Search the source libraries

Cancer mortality in India: a nationally representative survey.

Background: The age-specific mortality rates and total deaths from specific cancers have not been documented for the various regions and subpopulations of India. We therefore assessed the cause of death in 2001-03 in homes in small areas that were chosen to be representative of all the parts of India. Methods: At least 130 trained physicians independently assigned causes to 122,429 deaths, which occurred in 1·1 million homes in 6671 small areas that were randomly selected to be representative of all of India, based on a structured non-medical surveyor's field report. Findings: 7137 of 122,429 study deaths were due to cancer, corresponding to 556,400 national cancer deaths in India in 2010. 395,400 (71%) cancer deaths occurred in people aged 30-69 years (200,100 men and 195,300 women). At 30-69 years, the three most common fatal cancers were oral (including lip and pharynx, 45,800 [22·9%]), stomach (25,200 [12·6%]), and lung (including trachea and larynx, 22,900 [11·4%]) in men, and cervical (33,400 [17·1%]), stomach (27,500 [14·1%]), and breast (19,900 [10·2%]) in women. Tobacco-related cancers represented 42·0% (84,000) of male and 18·3% (35,700) of female cancer deaths and there were twice as many deaths from oral cancers as lung cancers. Age-standardised cancer mortality rates per 100,000 were similar in rural (men 95·6 [99% CI 89·6-101·7] and women 96·6 [90·7-102·6]) and urban areas (men 102·4 [92·7-112·1] and women 91·2 [81·9-100·5]), but varied greatly between the states, and were two times higher in the least educated than in the most educated adults (men, illiterate 106·6 [97·4-115·7] vs most educated 45·7 [37·8-53·6]; women, illiterate 106·7 [99·9-113·6] vs most educated 43·4 [30·7-56·1]). Cervical cancer was far less common in Muslim than in Hindu women (study deaths 24, age-standardised mortality ratio 0·68 [0·64-0·71] vs 340, 1·06 [1·05-1·08]). Interpretation: Prevention of tobacco-related and cervical cancers and earlier detection of treatable cancers would reduce cancer deaths in India, particularly in the rural areas that are underserved by cancer services. The substantial variation in cancer rates in India suggests other risk factors or causative agents that remain to be discovered. Funding: Bill & Melinda Gates Foundation and US National Institutes of Health.

Lancet (London, England) · 296 citationsread the source →

Cost and Outcome of Behavioural Activation versus Cognitive Behavioural Therapy for Depression (COBRA): a randomised, controlled, non-inferiority trial.

Background: Depression is a common, debilitating, and costly disorder. Many patients request psychological therapy, but the best-evidenced therapy-cognitive behavioural therapy (CBT)-is complex and costly. A simpler therapy-behavioural activation (BA)-might be as effective and cheaper than is CBT. We aimed to establish the clinical efficacy and cost-effectiveness of BA compared with CBT for adults with depression. Methods: In this randomised, controlled, non-inferiority trial, we recruited adults aged 18 years or older meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria for major depressive disorder from primary care and psychological therapy services in Devon, Durham, and Leeds (UK). We excluded people who were receiving psychological therapy, were alcohol or drug dependent, were acutely suicidal or had attempted suicide in the previous 2 months, or were cognitively impaired, or who had bipolar disorder or psychosis or psychotic symptoms. We randomly assigned participants (1:1) remotely using computer-generated allocation (minimisation used; stratified by depression severity [Patient Health Questionnaire 9 (PHQ-9) score of <19 vs ≥19], antidepressant use, and recruitment site) to BA from junior mental health workers or CBT from psychological therapists. Randomisation done at the Peninsula Clinical Trials Unit was concealed from investigators. Treatment was given open label, but outcome assessors were masked. The primary outcome was depression symptoms according to the PHQ-9 at 12 months. We analysed all those who were randomly allocated and had complete data (modified intention to treat [mITT]) and also all those who were randomly allocated, had complete data, and received at least eight treatment sessions (per protocol [PP]). We analysed safety in the mITT population. The non-inferiority margin was 1·9 PHQ-9 points. This trial is registered with the ISCRTN registry, number ISRCTN27473954. Findings: Between Sept 26, 2012, and April 3, 2014, we randomly allocated 221 (50%) participants to BA and 219 (50%) to CBT. 175 (79%) participants were assessable for the primary outcome in the mITT population in the BA group compared with 189 (86%) in the CBT group, whereas 135 (61%) were assessable in the PP population in the BA group compared with 151 (69%) in the CBT group. BA was non-inferior to CBT (mITT: CBT 8·4 PHQ-9 points [SD 7·5], BA 8·4 PHQ-9 points [7·0], mean difference 0·1 PHQ-9 points [95% CI -1·3 to 1·5], p=0·89; PP: CBT 7·9 PHQ-9 points [7·3]; BA 7·8 [6·5], mean difference 0·0 PHQ-9 points [-1·5 to 1·6], p=0·99). Two (1%) non-trial-related deaths (one [1%] multidrug toxicity in the BA group and one [1%] cancer in the CBT group) and 15 depression-related, but not treatment-related, serious adverse events (three in the BA group and 12 in the CBT group) occurred in three [2%] participants in the BA group (two [1%] patients who overdosed and one [1%] who self-harmed) and eight (4%) participants in the CBT group (seven [4%] who overdosed and one [1%] who self-harmed). Interpretation: We found that BA, a simpler psychological treatment than CBT, can be delivered by junior mental health workers with less intensive and costly training, with no lesser effect than CBT. Effective psychological therapy for depression can be delivered without the need for costly and highly trained professionals. Funding: National Institute for Health Research.

Lancet (London, England) · randomised controlled trial · 354 citationsread the source →

Internet-Delivered Exposure-Based Treatment vs. Stress Management for Irritable Bowel Syndrome: A Randomized Trial

OBJECTIVES: Our research group has developed an internet-delivered cognitive behavioral treatment (ICBT) for irritable bowel syndrome (IBS). We compared ICBT with internet-delivered stress management (ISM) for IBS to assess whether the effects of ICBT are specific. METHODS: This was a randomized controlled trial, including 195 self-referred participants diagnosed with IBS. The treatment interventions lasted for 10 weeks and included an online therapist contact. The ICBT emphasized acceptance of symptoms through exposure to IBS symptoms and related negative feelings. The ICBT also included mindfulness training. The ISM emphasized symptom control through relaxation techniques, dietary adjustments, and problem-solving skills. Severity of IBS symptoms was measured with the gastrointestinal symptom rating scale-IBS version (GSRS-IBS). Credibility of the treatments and expectancy of improvement were assessed with the treatment credibility scale. The participants' perceived therapeutic alliance with their online therapist was measured with the working alliance inventory. RESULTS: At post-treatment and 6-month follow-up, 192 (99%) and 169 (87%) participants returned data, respectively. At post-treatment and 6-month follow-up, we found significant differences on the GSRS-IBS, favoring ICBT. The difference on GSRS-IBS scores was 4.8 (95% confidence interval (CI): 1.2-8.4) at post-treatment and 5.9 (95% CI: 1.9-9.9) at 6-month follow-up. There were no significant differences on the treatment credibility scale or the working alliance inventory between the groups. CONCLUSIONS: Internet-delivered CBT has specific effects that cannot be attributed only to treatment credibility, expectancy of improvement, therapeutic alliance, or attention. Furthermore, a treatment based on exposure exercises specifically tailored for IBS may be a better treatment option than general stress and symptom management for IBS patients. ICBT is a promising treatment modality for IBS as it can be offered to IBS patients in much larger scale than conventional psychological treatments.

The American Journal of Gastroenterology · randomised controlled trial · 219 citationsread the source →

Gender differences among children with DSM-IV ADHD in Australia.

Objective: To examine gender differences among children meeting symptom criteria for DSM-IV attention-deficit/hyperactivity disorder (ADHD) identified in a nationally representative sample of Australian children. Method: From 2,404 children aged 6 to 13 years, 225 boys and 99 girls with ADHD symptoms were identified using the parent version of the Diagnostic Interview Schedule for Children and compared on parent reports of children's behavioral problems and impairment. Results: When ADHD types were collapsed into a single group, boys and girls did not differ on core symptoms, comorbidity, and impairment with the exception that girls rated higher on somatic complaints and boys had poorer school functioning. However, gender patterns were found to vary across ADHD type on impairment measures of social problems, schoolwork difficulties, and self-esteem, with boys being generally rated as more impaired in the combined and hyperactive-impulsive groups but equally or less impaired in the inattentive group. Conclusions: The findings suggest the possibility of gender-specific risks associated with high levels of inattentive and hyperactive-impulsive symptoms indicating that ADHD subtype membership should be considered when conducting ADHD gender comparisons.

Journal of the American Academy of Child and Adolescent Psychiatry · cohort or longitudinal · 79 citationsread the source →

Differential Mental Health Impact Six Months After Extensive River Flooding in Rural Australia: A Cross-Sectional Analysis Through an Equity Lens.

Background: Northern New South Wales in Australia is a "hotspot" for natural disaster declarations with recent extensive flooding in early 2017. With limited knowledge about how climate change affects mental health and resilience, robust local assessments are required to better understand long-term impact, particularly in communities prone to extreme weather events. Methods: Six months post-flood, a cross-sectional survey of adults living in the region during the flood was conducted to quantify associations between flood impact and psychological morbidity (post-traumatic stress (PTSD), anxiety, depression, suicidal ideation) for different exposure scenarios, and respondent groups. We adopted a community-academic partnership approach and purposive recruitment to increase participation from marginalized groups. Results: Of 2,180 respondents, almost all (91%) were affected by some degree of flood-related exposure at an individual and community level (ranging from suburb damage to home or business inundated). Socio-economically marginalized respondents were more likely to have their homes inundated and to be displaced. Mental health risk was significantly elevated for respondents: whose home/business/farm was inundated [e.g., home inundation: PTSD adjusted odds ratio (AOR) 13.72 (99% CI 4.53-41.56)]; who reported multiple exposures [e.g., three exposures: PTSD AOR 6.43 (99% CI 2.11-19.60)]; and who were still displaced after 6 months [e.g., PTSD AOR 24.43 (99% CI 7.05-84.69)]. Conclusion: The 2017 flood had profound impact, particularly for respondents still displaced and for socio-economically marginalized groups. Our community-academic partnership approach builds community cohesion, informs targeted mental health disaster preparedness and response policies for different sectors of the community and longer-term interventions aimed at improving community adaptability to climate change.

Frontiers in public health · 40 citationsread the source →

Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial.

Background: Obesity is associated with a reduction in life expectancy and an increase in mortality from cardiovascular diseases, cancer, and other causes. We therefore assessed the efficacy and safety of two doses of phentermine plus topiramate controlled-release combination as an adjunct to diet and lifestyle modification for weight loss and metabolic risk reduction in individuals who were overweight and obese, with two or more risk factors. Methods: In this 56-week phase 3 trial, we randomly assigned overweight or obese adults (aged 18-70 years), with a body-mass index of 27-45 kg/m(2) and two or more comorbidities (hypertension, dyslipidaemia, diabetes or prediabetes, or abdominal obesity) to placebo, once-daily phentermine 7·5 mg plus topiramate 46·0 mg, or once-daily phentermine 15·0 mg plus topiramate 92·0 mg in a 2:1:2 ratio in 93 centres in the USA. Drugs were administered orally. Patients were randomly assigned by use of a computer-generated algorithm that was implemented through an interactive voice response system, and were stratified by sex and diabetic status. Investigators, patients, and study sponsors were masked to treatment. Primary endpoints were the percentage change in bodyweight and the proportion of patients achieving at least 5% weight loss. Analysis was by intention to treat. This study is registered with Clinical Trials.gov, number NCT00553787. Findings: Of 2487 patients, 994 were assigned to placebo, 498 to phentermine 7·5 mg plus topiramate 46·0 mg, and 995 to phentermine 15·0 mg plus topiramate 92·0 mg; 979, 488, and 981 patients, respectively, were analysed. At 56 weeks, change in bodyweight was -1·4 kg (least-squares mean -1·2%, 95% CI -1·8 to -0·7), -8·1 kg (-7·8%, -8·5 to -7·1; p<0·0001), and -10·2 kg (-9·8%, -10·4 to -9·3; p<0·0001) in the patients assigned to placebo, phentermine 7·5 mg plus topiramate 46·0 mg, and phentermine 15·0 mg plus topiramate 92·0 mg, respectively. 204 (21%) patients achieved at least 5% weight loss with placebo, 303 (62%; odds ratio 6·3, 95% CI 4·9 to 8·0; p<0·0001) with phentermine 7·5 mg plus topiramate 46·0 mg, and 687 (70%; 9·0, 7·3 to 11·1; p<0·0001) with phentermine 15·0 mg plus topiramate 92·0 mg; for ≥10% weight loss, the corresponding numbers were 72 (7%), 182 (37%; 7·6, 5·6 to 10·2; p<0·0001), and 467 (48%; 11·7, 8·9 to 15·4; p<0·0001). The most common adverse events were dry mouth (24 [2%], 67 [13%], and 207 [21%] in the groups assigned to placebo, phentermine 7·5 mg plus topiramate 46·0 mg, and phentermine 15·0 mg plus topiramate 92·0 mg, respectively), paraesthesia (20 [2%], 68 [14%], and 204 [21%], respectively), constipation (59 [6%], 75 [15%], and 173 [17%], respectively), insomnia (47 [5%], 29 [6%], and 102 [10%], respectively), dizziness (31 [3%], 36 [7%], 99 [10%], respectively), and dysgeusia (11 [1%], 37 [7%], and 103 [10%], respectively). 38 (4%) patients assigned to placebo, 19 (4%) to phentermine 7·5 mg plus topiramate 46·0 mg, and 73 (7%) to phentermine 15·0 mg plus topiramate 92·0 mg had depression-related adverse events; and 28 (3%), 24 (5%), and 77 (8%), respectively, had anxiety-related adverse events. Interpretation: The combination of phentermine and topiramate, with office-based lifestyle interventions, might be a valuable treatment for obesity that can be provided by family doctors. Funding: Vivus.

Lancet (London, England) · randomised controlled trial · 667 citationsread the source →

"Favoring my playmate seems fair": Inhibitory control and theory of mind in preschoolers' self-disadvantaging behaviors.

The purpose of this study was to investigate the relationship between preschoolers' cognitive abilities and their fairness-related allocation behaviors in a dilemma of equity-efficiency conflict. In Experiment 1, 4- to 6-year-olds (N = 99) decided how to allocate five reward bells. In the first-party condition, preschoolers were asked to choose among giving more to self (self-advantageous inequity), wasting one bell (equity), or giving more to other (self-disadvantageous inequity); in the third-party condition, they chose either to allocate the extra bell to one of two equally deserving recipients or to waste it. Results showed that, compared with the pattern of decision in the third-party condition, preschoolers in the first-party condition were more likely to give the extra bell to other (self-disadvantaging behaviors) and that age, inhibitory control (IC), and theory of mind were positively correlated with their self-disadvantaging choices, but only IC mediated the relationship between age and self-disadvantaging behaviors. Experiment 2 (N = 41) showed that IC still predicted preschoolers' self-disadvantaging behaviors when they could choose only between equity and disadvantageous inequity. These results suggested that IC played a critical role in the implementation of self-disadvantaging behaviors when this required the control over selfishness and envy.

Journal of experimental child psychology · 8 citationsread the source →

Depression and resting state heart rate variability in children and adolescents - A systematic review and meta-analysis.

Among adults, depression is associated with reduced vagal activity, as indexed by high frequency heart rate variability [HF-HRV]), which correlates inversely with depression severity. Available evidence in depressed children and adolescents remains to be reviewed systematically. A search of the literature was performed to identify studies reporting (i) HF-HRV in clinically depressed children/adolescents relative to controls (k=4, n=259) and (ii) the association between HF-HRV and depressive symptoms as measured by standardized psychometric instruments in children and adolescents (k=6, n=2625). Random-effects meta-analysis on group differences revealed significant effects that were associated with a moderate effect size (Hedges' g=-0.59; 95% CI [-1.05; -0.13]), indicating lower resting state HF-HRV among clinically depressed children/adolescents (n=99) compared to healthy controls (n=160), consistent with findings among adults. While no correlation between HF-HRV and depressive symptom severity was observed (r=-.041 [-0.143; 0.062]), these additional correlational findings are limited to non-clinical samples. Findings have important clinical implications including a potentially increased risk for future physical ill health and also the identification of potential new treatment targets in child and adolescent depression.

Clinical psychology review · meta-analysis · 198 citationsread the source →

Do patients with bipolar disorder and subsyndromal symptoms benefit from functional remediation? A 12-month follow-up study.

We analyzed the efficacy of functional remediation, in a sample of patients with bipolar disorder who presented with subsyndromal symptoms. From a total sample of 239 patients with bipolar I and II disorder, according to DSM-IV-TR diagnostic criteria, entering a randomized clinical trial, those patients who presented with subsyndromal symptoms were selected based on a method already described by Berk and colleagues was applied. It consists of using the Clinical Global Impression-Bipolar version (CGI-BP) to establish the scores of the Hamilton Depression Rating Scale (HAM-D) and of the Young Mania Rating Scale (YMRS) that correspond with 1 in the CGI-BP. Functional outcome and mood symptoms were assessed at 6 and at 12-month follow-up. A total of 99 patients were selected for this post-hoc analysis, allocated as follows: functional remediation (n=33); psychoeducation (n=37) and treatment as usual (TAU,n=29). The repeated-measures analyses at 12-month follow-up revealed a significant group x time interaction in favour of the patients who received functional remediation when compared to psychoeducation and TAU (F=2.93; p=0.02) at improving psychosocial functioning. Finally, mood symptoms did not significantly change in any of the three groups at any time of follow-up, as shown by the non-significant group x time interaction effect in HAM-D scores (F=1.57; p=0.18) and YMRS scores (F=1.51; p=0.20). Bipolar patients with subsyndromal symptoms improve their functional outcome when exposed to functional remediation regardless of the persistence of mood symptomatology.

European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology · cohort or longitudinal · 24 citationsread the source →

Behavioural and cognitive-behavioural interventions for outwardly directed aggressive behaviour in people with intellectual disabilities.

Background: Outwardly directed aggressive behaviour in people with intellectual disabilities is a significant issue that may lead to poor quality of life, social exclusion and inpatient psychiatric admissions. Cognitive and behavioural approaches have been developed to manage aggressive behaviour but the effectiveness of these interventions on reducing aggressive behaviour and other outcomes are unclear. This is the third update of this review and adds nine new studies, resulting in a total of 15 studies in this review. Objectives: To evaluate the efficacy of behavioural and cognitive-behavioural interventions on outwardly directed aggressive behaviour compared to usual care, wait-list controls or no treatment in people with intellectual disability. We also evaluated enhanced interventions compared to non-enhanced interventions. Search methods: We used standard, extensive Cochrane search methods. The latest search date was March 2022. We revised the search terms to include positive behaviour support (PBS). Selection criteria: We included randomised and quasi-randomised trials of children and adults with intellectual disability of any duration, setting and any eligible comparator. Data collection and analysis: We used standard Cochrane methods. Our primary outcomes were change in 1. aggressive behaviour, 2. ability to control anger, and 3. adaptive functioning, and 4. Adverse effects: Our secondary outcomes were change in 5. mental state, 6. medication, 7. care needs and 8. quality of life, and 9. frequency of service utilisation and 10. user satisfaction data. We used GRADE to assess certainty of evidence for each outcome. We expressed treatment effects as mean differences (MD) or odds ratios (OR), with 95% confidence intervals (CI). Where possible, we pooled data using a fixed-effect model. Main results: This updated version comprises nine new studies giving 15 included studies and 921 participants. The update also adds new interventions including parent training (two studies), mindfulness-based positive behaviour support (MBPBS) (two studies), reciprocal imitation training (RIT; one study) and dialectical behavioural therapy (DBT; one study). It also adds two new studies on PBS. Most studies were based in the community (14 studies), and one was in an inpatient forensic service. Eleven studies involved adults only. The remaining studies involved children (one study), children and adolescents (one study), adolescents (one study), and adolescents and adults (one study). One study included boys with fragile X syndrome. Six studies were conducted in the UK, seven in the USA, one in Canada and one in Germany. Only five studies described sources of funding. Four studies compared anger management based on cognitive behaviour therapy to a wait-list or no treatment control group (n = 263); two studies compared PBS with treatment as usual (TAU) (n = 308); two studies compared carer training on mindfulness and PBS with PBS only (n = 128); two studies involving parent training on behavioural approaches compared to wait-list control or TAU (n = 99); one study of mindfulness to a wait-list control (n = 34); one study of adapted dialectal behavioural therapy compared to wait-list control (n = 21); one study of RIT compared to an active control (n = 20) and one study of modified relaxation compared to an active control group (n = 12). There was moderate-certainty evidence that anger management may improve severity of aggressive behaviour post-treatment (MD -3.50, 95% CI -6.21 to -0.79; P = 0.01; 1 study, 158 participants); very low-certainty evidence that it might improve self-reported ability to control anger (MD -8.38, 95% CI -14.05 to -2.71; P = 0.004, I2 = 2%; 3 studies, 212 participants), adaptive functioning (MD -21.73, 95% CI -36.44 to -7.02; P = 0.004; 1 study, 28 participants) and psychiatric symptoms (MD -0.48, 95% CI -0.79 to -0.17; P = 0.002; 1 study, 28 participants) post-treatment; and very low-certainty evidence that it does not improve quality of life post-treatment (MD -5.60, 95% CI -18.11 to 6.91; P = 0.38; 1 study, 129 participants) or reduce service utilisation and costs at 10 months (MD 102.99 British pounds, 95% CI -117.16 to 323.14; P = 0.36; 1 study, 133 participants). There was moderate-certainty evidence that PBS may reduce aggressive behaviour post-treatment (MD -7.78, 95% CI -15.23 to -0.32; P = 0.04, I2 = 0%; 2 studies, 275 participants) and low-certainty evidence that it probably does not reduce aggressive behaviour at 12 months (MD -5.20, 95% CI -13.27 to 2.87; P = 0.21; 1 study, 225 participants). There was low-certainty evidence that PBS does not improve mental state post-treatment (OR 1.44, 95% CI 0.83 to 2.49; P = 1.21; 1 study, 214 participants) and very low-certainty evidence that it might not reduce service utilisation at 12 months (MD -448.00 British pounds, 95% CI -1660.83 to 764.83; P = 0.47; 1 study, 225 participants). There was very low-certainty evidence that mindfulness may reduce incidents of physical aggression (MD -2.80, 95% CI -4.37 to -1.23; P < 0.001; 1 study; 34 participants) and low-certainty evidence that MBPBS may reduce incidents of aggression post-treatment (MD -10.27, 95% CI -14.86 to -5.67; P < 0.001, I2 = 87%; 2 studies, 128 participants). Reasons for downgrading the certainty of evidence were risk of bias (particularly selection and performance bias); imprecision (results from single, often small studies, wide CIs, and CIs crossing the null effect); and inconsistency (statistical heterogeneity). Authors' conclusions: There is moderate-certainty evidence that cognitive-behavioural approaches such as anger management and PBS may reduce outwardly directed aggressive behaviour in the short term but there is less certainty about the evidence in the medium and long term, particularly in relation to other outcomes such as quality of life. There is some evidence to suggest that combining more than one intervention may have cumulative benefits. Most studies were small and there is a need for larger, robust randomised controlled trials, particularly for interventions where the certainty of evidence is very low. More trials are needed that focus on children and whether psychological interventions lead to reductions in the use of psychotropic medications.

The Cochrane database of systematic reviews · systematic review · 6 citationsread the source →

A randomised clinical trial to evaluate the acceptability and efficacy of an early phase, online, guided augmentation of outpatient care for adults with anorexia nervosa.

Background: Outpatient interventions for adult anorexia nervosa typically have a modest impact on weight and eating disorder symptomatology. This study examined whether adding a brief online intervention focused on enhancing motivation to change and the development of a recovery identity (RecoveryMANTRA) would improve outcomes in adults with anorexia nervosa. Methods: Participants with anorexia nervosa (n = 187) were recruited from 22 eating disorder outpatient services throughout the UK. They were randomised to receiving RecoveryMANTRA in addition to treatment as usual (TAU) (n = 99; experimental group) or TAU only (n = 88; control group). Outcomes were measured at end-of-intervention (6 weeks), 6 and 12 months. Results: Adherence rates to RecoveryMANTRA were 83% for the online guidance sessions and 77% for the use of self-help materials (workbook and/or short video clips). Group differences in body mass index at 6 weeks (primary outcome) were not significant. Group differences in eating disorder symptoms, psychological wellbeing and work and social adjustment (at 6 weeks and at follow-up) were not significant, except for a trend-level greater reduction in anxiety at 6 weeks in the RecoveryMANTRA group (p = 0.06). However, the RecoveryMANTRA group had significantly higher levels of confidence in own ability to change (p = 0.02) and alliance with the therapist at the outpatient service (p = 0.005) compared to the control group at 6 weeks. Conclusions: Augmenting outpatient treatment for adult anorexia nervosa with a focus on recovery and motivation produced short-term reductions in anxiety and increased confidence to change and therapeutic alliance.

Psychological medicine · randomised controlled trial · 35 citationsread the source →

Psychotherapy for depression in older veterans via telemedicine: a randomised, open-label, non-inferiority trial.

Background: Many older adults with major depression, particularly veterans, do not have access to evidence-based psychotherapy. Telemedicine could increase access to best-practice care for older adults facing barriers of mobility, stigma, and geographical isolation. We aimed to establish non-inferiority of behavioural activation therapy for major depression delivered via telemedicine to same-room care in largely male, older adult veterans. Methods: In this randomised, controlled, open-label, non-inferiority trial, we recruited veterans (aged ≥58 years) meeting DSM-IV criteria for major depressive disorder from the Ralph H Johnson Veterans Affairs Medical Center and four associated community outpatient-based clinics in the USA. We excluded actively psychotic or demented people, those with both suicidal ideation and clear intent, and those with substance dependence. The study coordinator randomly assigned participants (1:1; block size 2-6; stratified by race; computer-generated randomisation sequence by RGK) to eight sessions of behavioural activation for depression either via telemedicine or in the same room. The primary outcome was treatment response according to the Geriatric Depression Scale (GDS) and Beck Depression Inventory (BDI; defined as a 50% reduction in symptoms from baseline at 12 months), and Structured Clinical Interview for DSM-IV, clinician version (defined as no longer being diagnosed with major depressive disorder at 12 months follow-up), in the per-protocol population (those who completed at least four treatment sessions and for whom all outcome measurements were done). Those assessing outcomes were masked. The non-inferiority margin was 15%. This trial is registered with ClinicalTrials.gov, number NCT00324701. Findings: Between April 1, 2007, and July 31, 2011, we screened 780 patients, and the study coordinator randomly assigned participants to either telemedicine (120 [50%]) or same-room treatment (121 [50%]). We included 100 (83%) patients in the per-protocol analysis in the telemedicine group and 104 (86%) in the same-room group. Treatment response according to GDS did not differ significantly between the telemedicine (22 [22·45%, 90% CI 15·52-29·38] patients) and same-room (21 [20·39%, 90% CI 13·86-26·92]) groups, with an absolute difference of 2·06% (90% CI -7·46 to 11·58). Response according to BDI also did not differ significantly (telemedicine 19 [24·05%, 90% CI 16·14-31·96] patients; same room 19 [23·17%, 90% CI 15·51-30·83]), with an absolute difference of 0·88% (90% CI -10·13 to 11·89). Response on the Structured Clinical Interview for DSM-IV, clinician version, also did not differ significantly (39 [43·33%, 90% CI 34·74-51·93] patients in the telemedicine group and 46 [48·42%, 90% CI 39·99-56·85] in the same-room group), with a difference of -5·09% (-17·13 to 6·95; p=0·487). Results from the intention-to-treat population were similar. MEM analyses showed that no significant differences existed between treatment trajectories over time for BDI and GDS. The criteria for non-inferiority were met. We did not note any adverse events. Interpretation: Telemedicine-delivered psychotherapy for older adults with major depression is not inferior to same-room treatment. This finding shows that evidence-based psychotherapy can be delivered, without modification, via home-based telemedicine, and that this method can be used to overcome barriers to care associated with distance from and difficulty with attendance at in-person sessions in older adults. Funding: US Department of Veterans Affairs.

The lancet. Psychiatry · randomised controlled trial · 123 citationsread the source →

Motivational interviewing targeting diet and physical activity improves adherence to paediatric obesity treatment: results from the MI Values randomized controlled trial.

Background: Adherence is a challenge in obesity treatment. Motivational interviewing (MI) may promote patient adherence. MI Values is a randomized controlled trial of MI implemented as an adjunct to an adolescent obesity treatment [Teaching Encouragement Exercise Nutrition Support (T.E.E.N.S.)]. Objective: Assess effects of MI Values on T.E.E.N.S. attrition and adherence. Methods: Participants were randomized to MI (n = 58) or control (n = 41). At weeks 1 and 10, MI participants had brief MI sessions; controls viewed health education videos. All participants continued with T.E.E.N.S. (biweekly dietitian and behavioural support visits; 3 times per week supervised physical activity). Assessments were repeated at baseline, 3 and 6 months. T-tests and chi-square analyses examined T.E.E.N.S. attrition and adherence by group. Results: Adolescents (N = 99) were primarily African-American (73%) females (74%); age = 13.8 ± 1.8 years, body mass index percentile = 98.0 ± 1.2. Compared with controls, MI participants had greater 3-month adherence overall (89.2% vs. 81.0%, P = 0.040), and to dietitian (91.3% vs. 84.0%; P = 0.046) and behavioural support (92.9% vs. 85.2%; P = 0.041) visits, and greater 6-month adherence overall (84.4% vs. 76.2%, P = 0.026) and to behavioural support visits (87.5% vs. 78.8%, P = 0.011). Conclusions: MI enhanced adherence to this obesity intervention. MI Values is the first study to examine the impact of MI on treatment adherence among obese, primarily African-American adolescents.

Pediatric obesity · randomised controlled trial · 54 citationsread the source →

Health behaviour outcomes of a family based intervention for paediatric obesity in primary care: A randomized type II hybrid effectiveness-implementation trial.

Background: Paediatric obesity is a multifaceted public health problem. Family based behavioural interventions are the recommended approach for the prevention of excess weight gain in children and adolescents, yet few have been tested under "real-world" conditions. Objectives: To evaluate the effectiveness of a family based intervention, delivered in coordination with paediatric primary care, on child and family health outcomes. Methods: A sample of 240 families with racially and ethnically diverse (86% non-White) and predominantly low-income children (49% female) ages 6 to 12 years (M = 9.5 years) with body mass index (BMI) ≥85th percentile for age and gender were identified in paediatric primary care. Participants were randomized to either the Family Check-Up 4 Health (FCU4Health) program (N = 141) or usual care plus information (N = 99). FCU4Health, an assessment-driven individually tailored intervention designed to preempt excess weight gain by improving parenting skills was delivered for 6 months in clinic, at home and in the community. Child BMI and body fat were assessed using a bioelectrical impedance scale and caregiver-reported health behaviours (eg, diet, physical activity and family health routines) were obtained at baseline, 3, 6 and 12 months. Results: Change in child BMI and percent body fat did not differ by group assignment. Path analysis indicated significant group differences in child health behaviours at 12 months, mediated by improved family health routines at 6 months. Conclusion: The FCU4Health, delivered in coordination with paediatric primary care, significantly impacted child and family health behaviours that are associated with the development and maintenance of paediatric obesity. BMI did not significantly differ.

Pediatric obesity · randomised controlled trial · 23 citationsread the source →

Symptoms and Distress in Children With Advanced Cancer: Prospective Patient-Reported Outcomes From the PediQUEST Study.

Purpose: Thousands of children are living with advanced cancer; yet patient-reported outcomes (PROs) have rarely been used to describe their experiences. We aimed to describe symptom distress in 104 children age 2 years or older with advanced cancer enrolled onto the Pediatric Quality of Life and Evaluation of Symptoms Technology (PediQUEST) Study (multisite clinical trial evaluating an electronic PRO system). Methods: Symptom data were collected using age- and respondent-adapted versions of the PediQUEST Memorial Symptom Assessment Scale (PQ-MSAS) at most once per week. Clinical and treatment data were obtained from medical records. Individual symptom scores were dichotomized into high/low distress. Determinants of PQ-MSAS scores were explored using linear mixed-effects models. Results: During 9 months of follow-up, PQ-MSAS was administered 920 times: 459 times in teens (99% self-report), 249 times in children ages 7 to 12 years (96% child/parent report), and 212 times in those ages 2 to 6 years (parent reports). Common symptoms included pain (48%), fatigue (46%), drowsiness (39%), and irritability (37%); most scores indicated high distress. Among the 73 PQ-MSAS surveys administered in the last 12 weeks of life, pain was highly prevalent (62%; 58% with high distress). Being female, having a brain tumor, experiencing recent disease progression, and receiving moderate- or high-intensity cancer-directed therapy in the prior 10 days were associated with worse PQ-MSAS scores. In the final 12 weeks of life, receiving mild cancer-directed therapy was associated with improved psychological PQ-MSAS scores. Conclusion: Children with advanced cancer experience high symptom distress. Strategies to promote intensive symptom management are indicated, especially with disease progression or administration of intensive treatments.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · randomised controlled trial · 212 citationsread the source →

Effect of an Internet-Delivered Stepped-Care Program vs In-Person Cognitive Behavioral Therapy on Obsessive-Compulsive Disorder Symptoms in Children and Adolescents: A Randomized Clinical Trial.

Importance: In most countries, young people with obsessive-compulsive disorder have limited access to specialist cognitive behavioral therapy (CBT), a first-line treatment. Objective: To investigate whether internet-delivered CBT implemented in a stepped-care model is noninferior to in-person CBT for pediatric obsessive-compulsive disorder. Design, setting and participants: A randomized clinical noninferiority trial conducted at 2 specialist child and adolescent mental health clinics in Sweden. Participants included 152 individuals aged 8 to 17 years with obsessive-compulsive disorder. Enrollment began in October 2017 and ended in May 2019. Follow-up ended in April 2020. Interventions: Participants randomized to the stepped-care group (n = 74) received internet-delivered CBT for 16 weeks. Nonresponders at the 3-month follow-up were then offered a course of traditional face-to-face treatment. Participants randomized to the control group (n = 78) immediately received in-person CBT for 16 weeks. Nonresponders at the 3-month follow-up received additional face-to-face treatment. Main outcomes and measures: The primary outcome was the masked assessor-rated Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score at the 6-month follow-up. The scale includes 10 items rated from 0 (no symptoms) to 4 (extreme symptoms), yielding a total score range of 0 to 40, with higher scores indicating greater severity. Assessors were masked to treatment allocation at pretreatment, posttreatment, 3-month follow-up, and 6-month follow-up assessments. The predefined noninferiority margin was 4 points on the CY-BOCS. Results: Among the 152 randomized participants (mean age, 13.4 years; 94 [62%] females), 151 (99%) completed the trial. At the 3-month follow-up, 34 participants (46%) in the stepped-care group and 23 (30%) in the in-person CBT group were nonresponders. At the 6-month follow-up, the CY-BOCS score was 11.57 points in the stepped-care group vs 10.57 points in the face-to-face treatment group, corresponding to an estimated mean difference of 0.91 points ([1-sided 97.5% CI, -∞ to 3.28]; P for noninferiority = .02). Increased anxiety (30%-36%) and depressive symptoms (20%-28%) were the most frequently reported adverse events in both groups. There were 2 unrelated serious adverse events (1 in each group). Conclusions and relevance: Among children and adolescents with obsessive-compulsive disorder, treatment with an internet-delivered CBT program followed by in-person CBT if necessary compared with in-person CBT alone resulted in a noninferior difference in symptoms at the 6-month follow-up. Further research is needed to understand the durability and generalizability of these findings. Trial registration: ClinicalTrials.gov Identifier: NCT03263546.

JAMA · randomised controlled trial · 42 citationsread the source →

Impact of motivational interviewing on outcomes of an adolescent obesity treatment: results from the MI Values randomized controlled pilot trial.

The aim of this study is to examine outcomes from MI Values, a motivational interviewing (MI) intervention implemented adjunctive to obesity treatment. Adolescents (n = 99; 73% African American; 74% female; mean body mass index [BMI] percentile = 98.9 ± 1.2) were randomized to receive two MI sessions or education control. All adolescents participated in structured behavioural weight management treatment. Baseline, 3- and 6-month assessments of anthropometrics, dietary intake and physical activity were obtained. Both groups had significant reductions in BMI z-scores and energy intake and increased physical activity at 3 and 6 months (P < 0.05). MI participants reported greater reductions in 3-month energy intake compared with controls. Participation in MI is associated with reduction in energy intake, consistent with better adherence to dietitian visits previously reported from MI Values. MI might be an effective adjunct to adolescent obesity treatment; future research is needed to determine if motivational interviewing can enhance BMI outcomes, via greater adherence to behavioural intervention.

Clinical obesity · randomised controlled trial · 27 citationsread the source →

Promoting school climate and health outcomes with the SEHER multi-component secondary school intervention in Bihar, India: a cluster-randomised controlled trial.

Background: School environments affect health and academic outcomes. With increasing secondary school retention in low-income and middle-income countries, promoting quality school social environments could offer a scalable opportunity to improve adolescent health and wellbeing. Methods: We did a cluster-randomised trial to assess the effectiveness of a multi-component whole-school health promotion intervention (SEHER) with integrated economic and process evaluations in grade 9 students (aged 13-14 years) at government-run secondary schools in the Nalanda district of Bihar state, India. Schools were randomly assigned (1:1:1) to three groups: the SEHER intervention delivered by a lay counsellor (the SEHER Mitra [SM] group), the SEHER intervention delivered by a teacher (teacher as SEHER Mitra [TSM] group), and a control group in which only the standard government-run classroom-based life-skills Adolescence Education Program was implemented. The primary outcome was school climate measured with the Beyond Blue School Climate Questionnaire (BBSCQ). Students were assessed at the start of the academic year (June, 2015) and again 8 months later at the end of the academic year (March, 2016) via self-completed questionnaires. This study is registered with ClinicalTrials.gov, number NCT02484014. Findings: Of the 112 eligible schools in the Nalanda district, 75 were randomly selected to participate in the trial. We randomly assigned 25 schools to each of the three groups. One school subsequently dropped out of the TSM group, leaving 24 schools in this group. The baseline survey included a total of 13 035 participants, and the endpoint survey included 14 414 participants. Participants in the SM-delivered intervention schools had substantially higher school climate scores at endpoint survey than those in the control group (BBSCQ baseline-adjusted mean difference [aMD] 7·57 [95% CI 6·11-9·03]; effect size 1·88 [95% CI 1·44-2·32], p<0·0001) and the TSM-delivered intervention (aMD 7·57 [95% CI 6·06-9·08]; effect size 1·88 [95% CI 1·43-2·34], p<0·0001). There was no effect of the TSM-delivered intervention compared with control (aMD -0·009 [95% CI -1·53 to 1·51], effect size 0·00 [95% CI -0·45 to 0·44], p=0·99). Compared with the control group, participants in the SM-delivered intervention schools had moderate to large improvements in the secondary outcomes of depression (aMD -1·23 [95% CI -1·89 to -0·57]), bullying (aMD -0·91 [95% CI -1·15 to -0·66]), violence victimisation (odds ratio [OR] 0·62 [95% CI 0·46-0·84]), violence perpetration (OR 0·68 [95% CI 0·48-0·96]), attitude towards gender equity (aMD 0·41 [95% CI 0·21-0·61]), and knowledge of reproductive and sexual health (aMD 0·29 [95% CI 0·06-0·53]). Similar results for these secondary outcomes were noted for the comparison between SM-delivered intervention schools and TSM-delivered intervention schools (depression: aMD -1·23 [95% CI -1·91 to -0·55]; bullying: aMD -0·83 [95% CI -1·08 to -0·57]; violence victimisation: OR 0·49 [95% CI 0·35-0·67]; violence perpetration: OR 0·49 [95% CI 0·34-0·71]; attitude towards gender equity: aMD 0·23 [95% CI 0·02-0·44]; and knowledge of reproductive and sexual health: aMD 0·22 [95% CI -0·02 to 0·47]). However, no effects on these secondary outcomes were observed for the TSM-delivered intervention schools compared with the control group (depression: aMD -0·03 [95% CI -0·70 to 0·65]; bullying: aMD -0·08 [95% CI -0·34 to 0·18]; violence victimisation: OR 1·27 [95% CI 0·93-1·73]; violence perpetration: OR 1·37 [95% CI 0·95-1·95]; attitude towards gender equity: aMD 0·17 [95% CI -0·09 to 0·38]; and knowledge of reproductive and sexual health: aMD 0·06 [95% CI -0·18 to 0·32]). Interpretation: The multi-component whole-school SEHER health promotion intervention had substantial beneficial effects on school climate and health-related outcomes when delivered by lay counsellors, but no effects when delivered by teachers. Future research should focus on the evaluation of the scaling up of the SEHER intervention in diverse contexts and delivery agents. Funding: John D. and Catherine T. MacArthur Foundation, USA and the United Nations Population Fund India Office.

Lancet (London, England) · randomised controlled trial · 121 citationsread the source →

Community psychosocial music intervention (CHIME) to reduce antenatal common mental disorder symptoms in The Gambia: a feasibility trial.

Objectives: Examine the feasibility of a Community Health Intervention through Musical Engagement (CHIME) in The Gambia to reduce common mental disorder (CMD) symptoms in pregnant women. Design: Feasibility trial testing a randomised stepped-wedge cluster design. Setting: Four local antenatal clinics. Participants: Women who were 14-24 weeks pregnant and spoke Mandinka or Wolof were recruited into the intervention (n=50) or control group (n=74). Intervention: Music-based psychosocial support sessions designed and delivered by all-female fertility societies. Sessions lasted 1 hour and were held weekly for 6 weeks. Delivered to groups of women with no preselection. Sessions were designed to lift mood, build social connection and provide health messaging through participatory music making. The control group received standard antenatal care. Outcomes: Demographic, feasibility, acceptability outcomes and the appropriateness of the study design were assessed. Translated measurement tools (Self-Reporting Questionnaire (SRQ-20); Edinburgh Postnatal Depression Scale (EPDS)) were used to assess CMD symptoms at baseline, post-intervention and 4-week follow-up. Results: All clinics and 82% of women approached consented to take part. A 33% attrition rate across all time points was observed. 72% in the intervention group attended at least three sessions. Audio and video analysis confirmed fidelity of the intervention and a thematic analysis of participant interviews demonstrated acceptability and positive evaluation. Results showed a potential beneficial effect with a reduction of 2.13 points (95% CI (0.89 to 3.38), p<0.01, n=99) on the SRQ-20 and 1.98 points (95% CI (1.06 to 2.90), p<0.01, n=99) on the EPDS at the post-intervention time point for the intervention group compared with standard care. Conclusion: Results demonstrate that CHIME is acceptable and feasible in The Gambia. To our knowledge, CHIME is the first example of a music-based psychosocial intervention to be applied to perinatal mental health in a low- and middle-income country context. Trial registration number: Pan African Clinical Trials Registry (PACTR201901917619299).

BMJ open · randomised controlled trial · 28 citationsread the source →

Comparison of behavioural activation with guided self-help for treatment of depression in adults with intellectual disabilities: a randomised controlled trial.

Background: Psychological therapies are first-line interventions for depression, but existing provision is not accessible for many adults with intellectual disabilities. We investigated the clinical and cost-effectiveness of a behavioural activation intervention (BeatIt) for people with intellectual disabilities and depression. BeatIt was compared with a guided self-help intervention (StepUp). Methods: We did a multicentre, single-blind, randomised, controlled trial with follow-up at 4 months and 12 months after randomisation. Participants aged 18 years or older, with mild to moderate intellectual disabilities and clinically significant depression were recruited from health and social care services in the UK. The primary outcome was the Glasgow Depression Scale for people with a Learning Disability (GDS-LD) score at 12 months. Analyses were done on an intention-to-treat basis. This trial is registered with ISCRTN, number ISRCTN09753005. Findings: Between Aug 8, 2013, and Sept 1, 2015, 161 participants were randomly assigned (84 to BeatIt; 77 to StepUp); 141 (88%) participants completed the trial. No group differences were found in the effects of BeatIt and StepUp based on GDS-LD scores at 12 months (12·03 [SD 7·99] GDS-LD points for BeatIt vs 12·43 [SD 7·64] GDS-LD points for StepUp; mean difference 0·26 GDS-LD points [95% CI -2·18 to 2·70]; p=0·833). Within-group improvements in GDS-LD scores occurred in both groups at 12 months (BeatIt, mean change -4·2 GDS-LD points [95% CI -6·0 to -2·4], p<0·0001; StepUp, mean change -4·5 GDS-LD points [-6·2 to -2·7], p<0·0001), with large effect sizes (BeatIt, 0·590 [95% CI 0·337-0·844]; StepUp, 0·627 [0·380-0·873]). BeatIt was not cost-effective when compared with StepUp, although the economic analyses indicated substantial uncertainty. Treatment costs were only approximately 3·6-6·8% of participants' total support costs. No treatment-related or trial-related adverse events were reported. Interpretation: This study is, to our knowledge, the first large randomised controlled trial assessing individual psychological interventions for people with intellectual disabilities and mental health problems. These findings show that there is no evidence that BeatIt is more effective than StepUp; both are active and potentially effective interventions. Funding: National Institute for Health Research.

The lancet. Psychiatry · randomised controlled trial · 49 citationsread the source →

Safety, tolerability, and immunogenicity of a 21-valent pneumococcal conjugate vaccine, V116, in healthy adults: phase 1/2, randomised, double-blind, active comparator-controlled, multicentre, US-based trial.

Background: A pneumococcal conjugate vaccine (PCV) specifically focused on serotypes associated with adult residual disease burden is urgently needed. We aimed to assess V116, an investigational 21-valent PCV, that contains pneumococcal polysaccharides (PnPs), which account for 74-94% of invasive pneumococcal disease in adults aged 65 years or older. Methods: We did a phase 1/2, randomised, double-blind, active comparator-controlled, multicentre, non-inferiority and superiority trial. The phase 1 study was done at two clinical sites in the USA, and the phase 2 study was done in 18 clinical sites in the USA. Eligible participants were healthy adults with or without chronic medical conditions assessed as stable, aged 18-49 years in the phase 1 trial and aged 50 years or older in the phase 2 trial. Participants were excluded if they had a history of invasive pneumococcal disease or other culture-positive pneumococcal disease within the past 3 years, known hypersensitivity to a vaccine component, known or suspected impairment of immunological function, were pregnant or were breastfeeding, or had previously received any pneumococcal vaccine. Participants had to abstain from sexual activity or use protocol approved contraception. All participants were centrally randomly assigned to a vaccine group using an interactive response technology system. Participants and investigators were masked to group assignment. In phase 1, participants were randomly assigned (1:1:1) to receive a single dose of V116-1 (2 μg per pneumococcal polysaccharide [PnP] per 0·5 mL) or V116-2 (4 μg per PnP per 1·0 mL) or the 23-valent unconjugated PnP vaccine, PPSV23 (25 μg per PnP per 0·5 mL). In phase 2, participants were randomly assigned (1:1) to receive one dose of V116 (4 μg per PnP per 1·0 mL) or PPSV23 (25 μg per PnP per 0·5 mL), stratified by age. Safety analyses included all randomly assigned participants who received study vaccine; immunogenicity analyses were per protocol. For both phases, the primary safety outcome was the proportion of participants with solicited injection-site adverse events and solicited systemic adverse events up to day 5 after vaccination and the proportion of participants with vaccine-related serious adverse events to 6 months after vaccination. In phase 2, primary immunogenicity outcomes were to test non-inferiority of V116 compared with PPSV23 as measured by serotype-specific opsonophagocytic antibody geometric mean titres (OPA-GMT) ratios for the serotypes common to the two vaccines at 30 days after vaccination (using a 0·33 margin) and to test superiority of V116 compared with PPSV23 as measured by serotype-specific OPA-GMT ratios for the serotypes unique to V116 at 30 days after vaccination (using a 1·0 margin). This trial is registered with Clinicaltrials.gov, NCT04168190. Findings: Between Dec 6 and 26, 2019, 92 volunteers were screened and 90 (98%) enrolled for phase 1 (59 [66%] women; 31 [34%] men); 30 participants were assigned to each group and received study vaccine. 30 (100%) participants in the V116-1 group, 29 (97%) in the V116-2 group, and 30 (100%) participants in the PPSV23 group were included in the per-protocol immunogenicity evaluation. From Sept 23, 2020, to Jan 12, 2021, 527 volunteers were screened, and 510 (97%) participants were enrolled in the phase 2 trial. 508 participants (>99%; 254 [100%] of 254 participants randomly assigned to the V116 group and 254 [99%] of 256 randomly assigned to PPSV23 group) received study vaccine (281 [55%] women; 227 [45%] men). 252 (99%) of 254 of participants in the V116 group and 254 (99%) of 256 participants in the PPSV23 group were included in the primary immunogenicity analyses. There were no vaccine-related serious adverse events or vaccine-related deaths in either study phase. In both phases, the most common solicited injection site adverse event was injection site pain (phase 1 22 [73%] participants in V116-1 group, 23 [77%] participants in V116-2 group, and 17 [57%] participants in the PPSV23 group; phase 2 118 [46%] of 254 participants in the V116 group and 96 [38%] of 254 in the PPSV23 group]. The most common solicited systemic adverse events in phase 1 was fatigue (eight [27%] participants in the V116-1 group, eight [27%] participants in the V116-2 group, and five [17%] participants in PPSV23 group) and myalgia (eight [27%] participants in the V116-1 group, nine (30%) participants in the V116-2 group, and four (13%) participants in the PPSV23 group]. In phase 2, the most frequently reported solicited systemic adverse event was fatigue (49 [19%] participants in V116 group, and 31 [12%] participants in PPSV23 group). In both phases, most of the solicited adverse events in all vaccine groups were mild and of short duration (≤3 days). V116 met non-inferiority criteria compared with PPSV23 for the 12 shared serotypes and met superiority criteria compared to PPSV23 for the nine unique serotypes. Interpretation: V116 was well tolerated with a safety profile generally similar to PPSV23; consistent with licensed pneumococcal conjugate vaccines. Functional OPA antibodies were induced to all V116 vaccine serotypes. The vaccine was non-inferior to PPSV23 for the 12 serotypes common to both vaccines and superior to PPSV23 for the nine unique serotypes in V116. Our findings support the development of V116 for prevention of pneumococcal disease in adults. Funding: Merck Sharp & Dohme, subsidiary of Merck & Co, Rahway, NJ, USA.

The Lancet. Infectious diseases · randomised controlled trial · 73 citationsread the source →

The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders Compared With Diagnosis-Specific Protocols for Anxiety Disorders: A Randomized Clinical Trial.

Importance: Transdiagnostic interventions have been developed to address barriers to the dissemination of evidence-based psychological treatments, but only a few preliminary studies have compared these approaches with existing evidence-based psychological treatments. Objective: To determine whether the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) is at least as efficacious as single-disorder protocols (SDPs) in the treatment of anxiety disorders. Design, setting, and participants: From June 23, 2011, to March 5, 2015, a total of 223 patients at an outpatient treatment center with a principal diagnosis of panic disorder with or without agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, or social anxiety disorder were randomly assigned by principal diagnosis to the UP, an SDP, or a waitlist control condition. Patients received up to 16 sessions of the UP or an SDP for 16 to 21 weeks. Outcomes were assessed at baseline, after treatment, and at 6-month follow-up. Analysis in this equivalence trial was based on intention to treat. Interventions: The UP or SDPs. Main outcomes and measures: Blinded evaluations of principal diagnosis clinical severity rating were used to evaluate an a priori hypothesis of equivalence between the UP and SDPs. Results: Among the 223 patients (124 women and 99 men; mean [SD] age, 31.1 [11.0] years), 88 were randomized to receive the UP, 91 to receive an SDP, and 44 to the waitlist control condition. Patients were more likely to complete treatment with the UP than with SDPs (odds ratio, 3.11; 95% CI, 1.44-6.74). Both the UP (Cohen d, -0.93; 95% CI, -1.29 to -0.57) and SDPs (Cohen d, -1.08; 95% CI, -1.43 to -0.73) were superior to the waitlist control condition at acute outcome. Reductions in clinical severity rating from baseline to the end of treatment (β, 0.25; 95% CI, -0.26 to 0.75) and from baseline to the 6-month follow-up (β, 0.16; 95% CI, -0.39 to 0.70) indicated statistical equivalence between the UP and SDPs. Conclusions and relevance: The UP produces symptom reduction equivalent to criterion standard evidence-based psychological treatments for anxiety disorders with less attrition. Thus, it may be possible to use 1 protocol instead of multiple SDPs to more efficiently treat the most commonly occurring anxiety and depressive disorders. Trial registration: clinicaltrials.gov Identifier: NCT01243606.

JAMA psychiatry · randomised controlled trial · 458 citationsread the source →

Effects of controlled school-based multi-component model of nutrition and lifestyle interventions on behavior modification, anthropometry and metabolic risk profile of urban Asian Indian adolescents in North India.

Background/objectives: To study the effectiveness of a multi-component intervention model of nutrition and lifestyle education on behavior modification, anthropometry and metabolic risk profile of urban Asian-Indian adolescents in North India. Subjects/methods: Two schools matched for student strength and middle socioeconomic strata were randomly allocated to intervention and control group. Changes in nutrition-related knowledge, attitude, lifestyle practices, food frequency and body image of eleventh-grade students (15-17 years) in both schools were tested using a validated questionnaire. Anthropometric and biochemical measurements were made using standard methods. Segmental body composition analysis was carried out using an 8-electrode multifrequency bioelectrical impedance method of body fat estimation. Results: At 6 months follow-up, significant improvement in several domains of knowledge was observed in intervention children (n=99; males=60; females=39) as compared with control school children (n=102; males=61; females=41). In the intervention group, significantly lower proportion of children consumed aerated drinks (15.1%; P<0.001) and energy-dense unhealthy foods (8.9%; P=0.03), whereas significantly higher proportion brought tiffin (packed lunch) to school (14.9%; P=0.004) and brought a fruit in their tiffin (30.7%; P<0.001) as compared with the control group. Significant decrease in mean waist circumference (P=0.02, 95% confidence interval (CI)=-2.43,-0.17), sagittal abdominal diameter (P<0.001, 95% CI=-0.82,-0.09), waist-to-hip ratio (P=0.02, 95% CI=-0.03,-0.004) and fasting blood glucose (P=0.05, 95% CI=-0.09, 5.00) was seen in intervention as compared with control school children. Conclusions: Multi-component model of nutrition and lifestyle education was successful in improving the nutrition-related knowledge, eating habits and lifestyle practices, and resulted in beneficial changes in anthropometric and biochemical profiles of the Asian Indian adolescents. This model should be applied on countrywide basis to prevent obesity and diabetes.

European journal of clinical nutrition · randomised controlled trial · 114 citationsread the source →

Preliminary results from a family-based HIV prevention intervention for South African youth.

Objectives: Approximately 5.6 million South Africans are living with human immunodeficiency virus (HIV; UNAIDS, 2010). Prevalence among Black adolescents and young adults is particularly alarming. This pilot study of an HIV preventive intervention targeting South African youth contributes to the growing body of research on culturally competent family-based interventions. Method: A total of 99 parent-child dyads were enrolled in an experimental repeated measures study, using a wait-list control group. Our 6-session intervention targeted general parenting (relationship quality, parental monitoring, and involvement), gender roles, and parent-youth communication about sex (content and quality). Parents and youth were assessed at baseline, postintervention, and 6-month follow-up. Eligibility included being the primary female caregiver of a 10- to 14-year-old child with whom they spent at least 4 nights a week and being able to participate in English or Xhosa. Results: Effect sizes with this small sample met or exceeded those of other family-based HIV interventions for youth in the United States and South Africa (e.g., Bell et al., 2008; Forehand et al., 2007). Parents' reports at postintervention indicated larger effect sizes for general parenting than youths' reports indicated. Parents' reports showed medium to large effects for all sex communication outcomes at postintervention and the 6-month follow-up. Youth reports demonstrated small to medium effects for most communication variables and these effects lasted through the 6-month follow-up period. Conclusions: Intergenerational social networks (e.g., families) hold promise for HIV prevention among South African youth. A full efficacy trial with longer-term follow-up and attention to maintenance of effects is warranted.

Health psychology : official journal of the Division of Health Psychology, American Psychological Association · randomised controlled trial · 25 citationsread the source →

Effectiveness of a web-based physical activity intervention in patients with knee and/or hip osteoarthritis: randomized controlled trial.

Background: Patients with knee and/or hip osteoarthritis (OA) are less physically active than the general population, while the benefits of physical activity (PA) have been well documented. Based on the behavioral graded activity treatment, we developed a Web-based intervention to improve PA levels in patients with knee and/or hip OA, entitled "Join2move". The Join2move intervention is a self-paced 9-week PA program in which the patient's favorite recreational activity is gradually increased in a time-contingent way. Objective: The aim of the study was to investigate whether a fully automated Web-based PA intervention in patients with knee and/or hip OA would result in improved levels of PA, physical function, and self-perceived effect compared with a waiting list control group. Methods: The study design was a two-armed randomized controlled trial which was not blinded. Volunteers were recruited via articles in newspapers and health-related websites. Eligibility criteria for participants were: (1) aged 50-75 years, (2) self-reported knee and/or hip OA, (3) self-reported inactivity (30 minutes of moderate PA, 5 times or less per week), (4) no face-to-face consultation with a health care provider other than general practitioners, for OA in the last 6 months, (5) ability to access the Internet weekly, and (6) no contra-indications to exercise without supervision. Baseline, 3-month, and 12-month follow-up data were collected through online questionnaires. Primary outcomes were PA, physical function, and self-perceived effect. In a subgroup of participants, PA was measured objectively using accelerometers. Secondary outcomes were pain, fatigue, anxiety, depression, symptoms, quality of life, self-efficacy, pain coping, and locus of control. Results: Of the 581 interested respondents, 199 eligible participants were randomly assigned to the intervention (n=100) or waiting list control group (n=99). Response rates of questionnaires were 84.4% (168/199) after 3 months and 75.4% (150/199) after 12 months. In this study, 94.0% (94/100) of participants actually started the program, and 46.0% (46/100) reached the adherence threshold of 6 out of 9 modules completed. At 3 months, participants in the intervention group reported a significantly improved physical function status (difference=6.5 points, 95% CI 1.8-11.2) and a positive self-perceived effect (OR 10.7, 95% CI 4.3-26.4) compared with the control group. No effect was found for self-reported PA. After 12 months, the intervention group showed higher levels of subjective (difference=21.2 points, 95% CI 3.6-38.9) and objective PA (difference=24 minutes, 95% CI 0.5-46.8) compared with the control group. After 12 months, no effect was found for physical function (difference=5 points, 95% CI -1.0 to 11.0) and self-perceived effect (OR 1.2, 95% CI 0.6-2.4). For several secondary endpoints, the intervention group demonstrated improvements in favor of the intervention group. Conclusions: Join2move resulted in changes in the desired direction for several primary and secondary outcomes. Given the benefits and its self-help format, Join2move could be a component in the effort to enhance PA in sedentary patients with knee and/or hip OA.

Journal of medical Internet research · randomised controlled trial · 141 citationsread the source →

Internet-based intervention for smoking cessation (StopAdvisor) in people with low and high socioeconomic status: a randomised controlled trial.

Background: Internet-based interventions for smoking cessation could help millions of people stop smoking at very low unit costs; however, long-term biochemically verified evidence is scarce and such interventions might be less effective for smokers with low socioeconomic status than for those with high status because of lower online literacy to engage with websites. We aimed to assess a new interactive internet-based intervention (StopAdvisor) for smoking cessation that was designed with particular attention directed to people with low socioeconomic status. Methods: We did this online randomised controlled trial between Dec 6, 2011, and Oct 11, 2013, in the UK. Participants aged 18 years and older who smoked every day were randomly assigned (1:1) to receive treatment with StopAdvisor or an information-only website. Randomisation was automated with an unseen random number function embedded in the website to establish which treatment was revealed after the online baseline assessment. Recruitment continued until the required sample size had been achieved from both high and low socioeconomic status subpopulations. Participants, and researchers who obtained data and did laboratory analyses, were masked to treatment allocation. The primary outcome was 6 month sustained, biochemically verified abstinence. The main secondary outcome was 6 month, 7 day biochemically verified point prevalence. Analysis was by intention to treat. Homogeneity of intervention effect across the socioeconomic subsamples was first assessed to establish whether overall or separate subsample analyses were appropriate. The study is registered as an International Standard Randomised Controlled Trial, number ISRCTN99820519. Findings: We randomly assigned 4613 participants to the StopAdvisor group (n=2321) or the control group (n=2292); 2142 participants were of low socioeconomic status and 2471 participants were of high status. The overall rate of smoking cessation was similar between participants in the StopAdvisor and control groups for the primary (237 [10%] vs 220 [10%] participants; relative risk [RR] 1·06, 95% CI 0·89-1·27; p=0·49) and the secondary (358 [15%] vs 332 [15%] participants; 1·06, 0·93-1·22; p=0·37) outcomes; however, the intervention effect differed across socioeconomic status subsamples (1·44, 0·99-2·09; p=0·0562 and 1·37, 1·02-1·84; p=0·0360, respectively). StopAdvisor helped participants with low socioeconomic status stop smoking compared with the information-only website (primary outcome: 90 [8%] of 1088 vs 64 [6%] of 1054 participants; RR 1·36, 95% CI 1·00-1·86; p=0·0499; secondary outcome: 136 [13%] vs 100 [10%] participants; 1·32, 1·03-1·68, p=0·0267), but did not improve cessation rates in those with high socioeconomic status (147 [12%] of 1233 vs 156 [13%] of 1238 participants; 0·95, 0·77-1·17; p=0·61 and 222 [18%] vs 232 [19%] participants; 0·96, 0·81-1·13, p=0·64, respectively). Interpretation: StopAdvisor was more effective than an information-only website in smokers of low, but not high, socioeconomic status. StopAdvisor could be implemented easily and made freely available, which would probably improve the success rates of smokers with low socioeconomic status who are seeking online support. Funding: National Prevention Research Initiative.

The Lancet. Respiratory medicine · randomised controlled trial · 99 citationsread the source →

Cognitive behavioural treatment for women who have menopausal symptoms after breast cancer treatment (MENOS 1): a randomised controlled trial.

Background: Hot flushes and night sweats (HFNS) affect 65-85% of women after breast cancer treatment; they are distressing, causing sleep problems and decreased quality of life. Hormone replacement therapy is often either undesirable or contraindicated. Safe, effective non-hormonal treatments are needed. We investigated whether cognitive behavioural therapy (CBT) can help breast cancer survivors to effectively manage HFNS. Methods: In this randomised controlled trial, we recruited women from breast clinics in London, UK, who had problematic HFNS (minimum ten problematic episodes a week) after breast-cancer treatment. Participants were randomly allocated to receive either usual care or usual care plus group CBT (1:1). Randomisation was done in blocks of 12-20 participants, stratifying by age (younger than 50 years, 50 years or older), and was done with a computer-generated sequence. The trial statistician and researchers collecting outcome measures were masked to group allocation. Group CBT comprised one 90 min session a week for 6 weeks, and included psycho-education, paced breathing, and cognitive and behavioural strategies to manage HFNS. Assessments were done at baseline, 9 weeks, and 26 weeks after randomisation. The primary outcome was the adjusted mean difference in HFNS problem rating (1-10) between CBT and usual care groups at 9 weeks after randomisation. Analysis of the primary endpoint was done by modified intention to treat. The trial is registered, ISRCTN13771934, and was closed March 15, 2011. Findings: Between May 5, 2009, and Aug 27, 2010, 96 women were randomly allocated to group CBT (n=47) or usual care (n=49). Group CBT significantly reduced HFNS problem rating at 9 weeks after randomisation compared with usual care (mean difference -1·67, 95% CI -2·43 to -0·91; p<0·0001) and improvements were maintained at 26 weeks (mean difference -1·76, -2·54 to -0·99; p<0·0001). We recorded no CBT-related adverse events. Interpretation: Group CBT seems to be a safe and effective treatment for women who have problematic HFNS after breast cancer treatment with additional benefits to mood, sleep, and quality of life. The treatment could be incorporated into breast cancer survivorship programmes and delivered by trained breast cancer nurses. Funding: Cancer Research UK.

The Lancet. Oncology · randomised controlled trial · 190 citationsread the source →

Anxiety diagnoses in smokers seeking cessation treatment: relations with tobacco dependence, withdrawal, outcome and response to treatment.

Aims: To understand the relations among anxiety disorders and tobacco dependence, withdrawal symptoms, response to smoking cessation pharmacotherapy and ability to quit smoking. Design: Randomized placebo-controlled clinical trial. Participants received six 10-minute individual counseling sessions and either: placebo, bupropion SR, nicotine patch, nicotine lozenge, bupropion SR + nicotine lozenge or nicotine patch + nicotine lozenge. Setting: Two urban research sites. Participants: Data were collected from 1504 daily smokers (>9 cigarettes per day) who were motivated to quit smoking and did not report current diagnoses of schizophrenia or psychosis or bupropion use. Measurements: Participants completed baseline assessments, the Composite International Diagnostic Interview and ecological momentary assessments for 2 weeks. Findings: A structured clinical interview identified participants who ever met criteria for a panic attack (n = 455), social anxiety (n = 199) or generalized anxiety disorder (n = 99), and those who qualified for no anxiety diagnosis (n = 891). Smokers with anxiety disorders reported higher levels of nicotine dependence and pre-quit withdrawal symptoms. Those ever meeting criteria for panic attacks or social anxiety disorder showed greater quit-day negative affect. Smokers ever meeting criteria for anxiety disorders were less likely to be abstinent at 8 weeks and 6 months post-quit and showed no benefit from single-agent or combination-agent pharmacotherapies. Conclusions: Anxiety diagnoses were common among treatment-seeking smokers and were related to increased motivation to smoke, elevated withdrawal, lack of response to pharmacotherapy and impaired ability to quit smoking. These findings could guide treatment assignment algorithms and treatment development for smokers with anxiety diagnoses.

Addiction (Abingdon, England) · randomised controlled trial · 141 citationsread the source →

Predictors of diaphragm use as a potential sexually transmitted disease/HIV prevention method in Zimbabwe.

Background: Women who are the most vulnerable to sexually transmitted diseases/HIV are often unable to consistently use condoms. One potential alternative method currently under investigation is the diaphragm. Goals: The goals of this study were to assess diaphragm uptake and use over time in Zimbabwe and to identify factors associated with self-reported consistent diaphragm use. Study: Women attending family planning clinics who were inconsistent condom users received a diaphragm intervention and were followed for 6 months. Results: Of the 186 participants, 99% ever reported using the diaphragm, and, at study exit, 96% had used it in the previous 2 months. Consistent diaphragm use since the previous visit was reported by 13% to 16% of the women, and in multivariate regression analysis, it was significantly associated with never using condoms (adjusted odds ratio, 24.08; 95% confidence interval, 6.71-86.34). Other factors included discreet use, preferring diaphragms to condoms, timing of insertion, domestic violence, and contraception. Conclusion: Diaphragms were well accepted among women at risk for sexually transmitted diseases/HIV.

Sexually transmitted diseases · 34 citationsread the source →

Transcaval Access and Closure for Transcatheter Aortic Valve Replacement: A Prospective Investigation.

Background: Transcaval access may enable fully percutaneous transcatheter aortic valve replacement (TAVR) without the hazards and discomfort of transthoracic (transapical or transaortic) access. Objectives: The authors performed a prospective, independently adjudicated, multicenter, single-arm trial of transcaval access for TAVR in patients who were ineligible for femoral artery access and had high or prohibitive risk of complications from transthoracic access. Methods: A total of 100 patients underwent attempted percutaneous transcaval access to the abdominal aorta by electrifying a caval guidewire and advancing it into a pre-positioned aortic snare. After exchanging for a rigid guidewire, conventional TAVR was performed through transcaval introducer sheaths. Transcaval access ports were closed with nitinol cardiac occluders. A core laboratory analyzed pre-discharge and 30-day abdominal computed tomograms. The Society of Thoracic Surgeons predicted risk of mortality was 9.6 ± 6.3%. Results: Transcaval access was successful in 99 of 100 patients. Device success (access and closure with a nitinol cardiac occluder without death or emergency surgical rescue) occurred 98 of 99 patients; 1 subject had closure with a covered stent. Inpatient survival was 96%, and 30-day survival was 92%. Second Valve Academic Research Consortium (VARC-2) life-threatening bleeding and modified VARC-2 major vascular complications possibly related to transcaval access were 7% and 13%, respectively. Median length of stay was 4 days (range 2 to 6 days). There were no vascular complications after discharge. Conclusions: Transcaval access enabled TAVR in patients who were not good candidates for transthoracic access. Bleeding and vascular complications, using permeable nitinol cardiac occluders to close the access ports, were common but acceptable in this high-risk cohort. Transcaval access should be investigated in patients who are eligible for transthoracic access. Purpose-built closure devices are in development that may simplify the procedure and reduce bleeding. (Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access; NCT02280824).

Journal of the American College of Cardiology · cohort or longitudinal · 155 citationsread the source →

Self-Injurious Thoughts and Behaviors Interview: development, reliability, and validity in an adolescent sample.

The authors developed the Self-Injurious Thoughts and Behaviors Interview (SITBI) and evaluated its psychometric properties. The SITBI is a structured interview that assesses the presence, frequency, and characteristics of a wide range of self-injurious thoughts and behaviors, including suicidal ideation, suicide plans, suicide gestures, suicide attempts, and nonsuicidal self-injury (NSSI). This initial study, based on the administration of the SITBI to 94 adolescents and young adults, suggested that the SITBI has strong interrater reliability (average kappa = .99, r = 1.0) and test-retest reliability (average kappa = .70, intraclass correlation coefficient = .44) over a 6-month period. Moreover, concurrent validity was demonstrated via strong correspondence between the SITBI and other measures of suicidal ideation (average kappa = .54), suicide attempt (kappa = .65), and NSSI (average kappa = .87). The authors concluded that the SITBI uniformly and comprehensively assesses a wide range of self-injury-related constructs and provides a new instrument that can be administered with relative ease in both research and clinical settings.

Psychological assessment · cohort or longitudinal · 844 citationsread the source →

Spiritual, religious, and personal beliefs are important and distinctive to assessing quality of life in health: a comparison of theoretical models.

Objectives: The study investigates theoretical debates on the contribution of spiritual, religious, and personal beliefs (SRPB) to quality of life (QoL) in health, by examining contrasting models. Design and method: The WHOQOL-SRPB assesses QoL relating to SRPB where 33 QoL facets are scored in 6 domains, of which SRPB is one. The measure was completed by a heterogeneous sample of 285 sick and well people representing a cross-section of religious, agnostic, and atheist beliefs in UK, and structured for gender (52% female) and age (mean 47 years). Results: No evidence was found to support the model of spiritual QoL as a concept that overarches every other QoL domain. Confirmatory factor analysis showed that SRPB is an integral concept to overall QoL, with a very good fit (comparative fit index=.99). Spiritual QoL made a significant, relatively independent contribution, similar to the other five domains (β=0.68). Spiritual QoL is most closely associated with the psychological domain, particularly hope and optimism and inner peace; two of the nine SRPB facets. Spiritual QoL, but not most other aspects of QoL, is higher for religious people. Conclusion: The results explain theoretical confusion arising from previous research. Spiritual QoL makes a significant and distinctive contribution to QoL assessment in health and should be assessed routinely in health care populations.

British journal of health psychology · cohort or longitudinal · 26 citationsread the source →

Digital Technologies for Health Promotion and Disease Prevention in Older People: Scoping Review.

Background: Digital technologies have the potential to contribute to health promotion and disease prevention in the aging world. Objective: This study aims to identify digital technologies for health promotion and disease prevention that could be used independently by older people in nonclinical settings using a scoping review. Methods: Through database (MEDLINE, PsycINFO, CINAHL, and SCOPUS; to March 3, 2022) and manual searches (to June 14, 2022), 90 primary studies and 8 systematic reviews were included in this scoping review. The eligibility was based on the PCC (Population, Concept, and Context) criteria: (1) people aged 50 years or older (population), (2) any digital (health) technology (eg, smartphone apps, websites, virtual reality; concept), and (3) health promotion and disease prevention in daily life in nonclinical and noninstitutional settings (context). Data items included study characteristics, PCC criteria, opportunities versus challenges, and evidence gaps. Data were synthesized using descriptive statistics or narratively described by identifying common themes. Results: The studies were published in 2005-2022 and originated predominantly from North America and Europe. Most primary studies were nonrandomized, reported quantitative data, and investigated effectiveness or feasibility (eg, acceptance or usability) of digital technologies in older people. The participants were aged 50 years to 99 years, predominantly female, affluent (ie, with high income, education, and digital competence), and intended to use or used digital technologies for a median of 3 months independently at home or in community settings. The digital technologies included mobile or nonmobile technologies or virtual reality. The studies used "modern devices" (eg, smartphones, wearables, or gaming consoles) or modern and "older devices" (eg, computers or mobile phones). The users interacted with digital technologies via websites, emails, text messages, apps, or virtual reality. Health targets of digital technologies were mobility, mental health, nutrition, or cognition. The opportunities versus challenges of digital technologies were (1) potential health benefits versus unclear or no benefits for some outcomes, (2) monitoring of health versus ethical issues with data collection and management, (3) implications for functioning in daily life (ie, potential to prolong independent living) versus unclear application for clinical management or care, (4) tailoring of technical properties and content toward older users versus general use, (5) importance of human support for feasibility versus other factors required to improve feasibility, (6) reduction of social isolation versus access to digital technologies, and (7) improvement in digital competence versus digital divide. Conclusions: Various digital technologies were independently used by people aged 50 years or older for health promotion and disease prevention. Future studies should focus on (1) more diverse populations of older people, (2) new digital technologies, (3) other (clinical and care) settings, and (4) outcome evaluation to identify factors that could enhance any health benefits of digital technologies. International registered report identifier (irrid): RR2-10.2196/37729.

Journal of medical Internet research · review · 79 citationsread the source →

Every Newborn: progress, priorities, and potential beyond survival.

In this Series paper, we review trends since the 2005 Lancet Series on Neonatal Survival to inform acceleration of progress for newborn health post-2015. On the basis of multicountry analyses and multi-stakeholder consultations, we propose national targets for 2035 of no more than 10 stillbirths per 1000 total births, and no more than 10 neonatal deaths per 1000 livebirths, compatible with the under-5 mortality targets of no more than 20 per 1000 livebirths. We also give targets for 2030. Reduction of neonatal mortality has been slower than that for maternal and child (1-59 months) mortality, slowest in the highest burden countries, especially in Africa, and reduction is even slower for stillbirth rates. Birth is the time of highest risk, when more than 40% of maternal deaths (total about 290,000) and stillbirths or neonatal deaths (5·5 million) occur every year. These deaths happen rapidly, needing a rapid response by health-care workers. The 2·9 million annual neonatal deaths worldwide are attributable to three main causes: infections (0·6 million), intrapartum conditions (0·7 million), and preterm birth complications (1·0 million). Boys have a higher biological risk of neonatal death, but girls often have a higher social risk. Small size at birth--due to preterm birth or small-for-gestational-age (SGA), or both--is the biggest risk factor for more than 80% of neonatal deaths and increases risk of post-neonatal mortality, growth failure, and adult-onset non-communicable diseases. South Asia has the highest SGA rates and sub-Saharan Africa has the highest preterm birth rates. Babies who are term SGA low birthweight (10·4 million in these regions) are at risk of stunting and adult-onset metabolic conditions. 15 million preterm births, especially of those younger than 32 weeks' gestation, are at the highest risk of neonatal death, with ongoing post-neonatal mortality risk, and important risk of long-term neurodevelopmental impairment, stunting, and non-communicable conditions. 4 million neonates annually have other life-threatening or disabling conditions including intrapartum-related brain injury, severe bacterial infections, or pathological jaundice. Half of the world's newborn babies do not get a birth certificate, and most neonatal deaths and almost all stillbirths have no death certificate. To count deaths is crucial to change them. Failure to improve birth outcomes by 2035 will result in an estimated 116 million deaths, 99 million survivors with disability or lost development potential, and millions of adults at increased risk of non-communicable diseases after low birthweight. In the post-2015 era, improvements in child survival, development, and human capital depend on ensuring a healthy start for every newborn baby--the citizens and workforce of the future.

Lancet (London, England) · review · 1326 citationsread the source →

Essential Hypertension

HomeCirculationVol. 101, No. 3Essential Hypertension Free AccessOtherPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyRedditDiggEmail Jump toFree AccessOtherPDF/EPUBEssential Hypertension Part I: Definition and Etiology Oscar A. Carretero and Suzanne Oparil Oscar A. CarreteroOscar A. Carretero From the Hypertension and Vascular Research Division, Heart and Vascular Institute, Henry Ford Hospital, Detroit, Mich (O.A.C.), and the Division of Cardiovascular Disease, Vascular Biology and Hypertension Program, University of Alabama School of Medicine, Birmingham (S.O.). and Suzanne OparilSuzanne Oparil From the Hypertension and Vascular Research Division, Heart and Vascular Institute, Henry Ford Hospital, Detroit, Mich (O.A.C.), and the Division of Cardiovascular Disease, Vascular Biology and Hypertension Program, University of Alabama School of Medicine, Birmingham (S.O.). Originally published25 Jan 2000https://doi.org/10.1161/01.CIR.101.3.329Circulation. 2000;101:329–335Essential hypertension remains a major modifiable risk factor for cardiovascular disease (CVD) despite important advances in our understanding of its pathophysiology and the availability of effective treatment strategies. High blood pressure (BP) increases the risk of CVD for millions of people worldwide, and there is evidence that the problem is only getting worse. In the past decade, age-adjusted rates of stroke incidence have risen, and the slope of the age-adjusted rate of decline in coronary disease has leveled off. The incidence of end-stage renal disease and the prevalence of heart failure have also increased. A major contributor to these trends is inadequate control of BP in the hypertensive population. This review of current concepts regarding the definition, etiology, and treatment of essential hypertension is intended to aid the clinician in identifying those individuals at high risk who need to undergo evaluation and treatment, as well as in selecting optimal treatment strategies for hypertensive patients with comorbid conditions and/or target organ damage. The part of the review that deals with the genetic basis of hypertension and the gene/environment interaction that may lead to elevated BP is still a work in progress. Information gained from the Human Genome Project and from ongoing studies of the genetic basis of hypertension both in animal models and human populations may revolutionize the treatment of hypertension by replacing current empirical therapy with more effective, targeted treatments based on the genotype of the patient. Concepts introduced in this review form the basis for such "pharmacogenomic" approaches to antihypertensive therapy. Definition of Essential or Primary HypertensionBP is a quantitative trait that is highly variable1 ; in population studies, BP has a normal distribution that is slightly skewed to the right. There is a strong positive and continuous correlation between BP and the risk of CVD (stroke, myocardial infarction, heart failure), renal disease, and mortality, even in the normotensive range. This correlation is more robust with systolic than with diastolic BP.2 There is no specific level of BP where cardiovascular and renal complications start to occur; thus the definition of hypertension is arbitrary but needed for practical reasons in patient assessment and treatment. The Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI) defined and classified hypertension in adults, as shown in Table 1.3 The diagnosis of hypertension is made when the average of 2 or more diastolic BP measurements on at least 2 subsequent visits is ≥90 mm Hg or when the average of multiple systolic BP readings on 2 or more subsequent visits is consistently ≥140 mm Hg. Isolated systolic hypertension is defined as systolic BP ≥140 mm Hg and diastolic BP <90 mm Hg. Individuals with high normal BP tend to maintain pressures that are above average for the general population and are at greater risk for development of definite hypertension and cardiovascular events than the general population. With the use of these definitions, it is estimated that 43 million people in the United States have hypertension or are taking antihypertensive medication, which is ≈24% of the adult population. This proportion changes with (1) race, being higher in blacks (32.4%) and lower in whites (23.3%) and Mexican Americans (22.6%); (2) age, because in industrialized countries systolic BP rises throughout life, whereas diastolic BP rises until age 55 to 60 years and thus the greater increase in prevalence of hypertension among the elderly is mainly due to systolic hypertension; (3) geographic patterns, because hypertension is more prevalent in the southeastern United States; (4) gender, because hypertension is more prevalent in men (though menopause tends to abolish this difference); and (5) socioeconomic status, which is an indicator of lifestyle attributes and is inversely related to the prevalence, morbidity, and mortality rates of hypertension. Essential, primary, or idiopathic hypertension is defined as high BP in which secondary causes such as renovascular disease, renal failure, pheochromocytoma, aldosteronism, or other causes of secondary hypertension or mendelian forms (monogenic) are not present. Essential hypertension accounts for 95% of all cases of hypertension. Essential hypertension is a heterogeneous disorder, with different patients having different causal factors that lead to high BP. Essential hypertension needs to be separated into various syndromes because the causes of high BP in most patients presently classified as having essential hypertension can be recognized. Known Etiological Factors in Essential HypertensionAlthough it has frequently been indicated that the causes of essential hypertension are not known, this is only partially true because we have little information on genetic variations or genes that are overexpressed or underexpressed as well as the intermediary phenotypes that they regulate to cause high BP.4 A number of factors increase BP, including (1) obesity, (2) insulin resistance, (3) high alcohol intake, (4) high salt intake (in salt-sensitive patients), (5) aging and perhaps (6) sedentary lifestyle, (7) stress, (8) low potassium intake, and (9) low calcium intake.56 Furthermore, many of these factors are additive, such as obesity and alcohol intake. In this review, variations in BP that are genetically determined will be called "inherited BP," although we do not know which genes cause BP to vary; we know from family studies that inherited BP can range from low normal BP to severe hypertension. Factors that increase BP, such as obesity and high alcohol and salt intake, will be called "hyperten-sinogenic factors." Some of these factors have inherited, behavioral, and environmental components. Inherited BP could be considered core BP, whereas hypertensinogenic factors cause BP to increase above the range of inherited BPs, thus creating 4 main possibilities: (1) patients who have inherited BP in the optimal category (<120/<80 mm Hg); if 1 or more hypertensinogenic factors are added, BP would probably increase but remain in the normal range (<135/<85 mm Hg) (Figure 1, first 2 columns); (2) patients who have inherited BP in the normal category (≤130/≤85 mm Hg); if 1 or more hypertensinogenic factors are added, BP will probably increase to the high normal range (130 to 139/85 to 89 mm Hg) or to stage 1 of the hypertensive category (140 to 159/90 to 99 mm Hg) (Figure 1, second 2 columns); (3) patients who have inherited BP in the high normal category (130 to 139/85 to 89 mm Hg); if 1 or more hypertensinogenic factors are added, BP will increase to the hypertensive range (≥140/≥90 mm Hg) (Figure 1, third 2 columns); and (4) patients who have inherited BP in the hypertensive range; addition of 1 or more hypertensinogenic factors will make hypertension more severe, changing it from stage 1 to stage 2 or 3 (Figure 1, fourth to sixth 2 columns).Theoretically, in a population unaffected by hypertensinogenic factors, BP will have a normal distribution; it will be skewed to the right and will have a narrow base or less variance (Figure 2, continuous line). When 1 hypertensinogenic factor is added to this population, such as increased body mass, one would expect the normal distribution curve to be further skewed to the right; consequently the base will be wider (more variance) and the curve will be flatter (Figure 2, broken line). If a second hypertensinogenic factor such as alcohol intake is added to increased body mass, the curve will be skewed more to the right and the variance will increase further, with more subjects classified as hypertensive (Figure 2, dotted line).Discovering which genetic variations place BP on the left or right side of the distribution curve is of both theoretical and practical importance because it could help the physician to better treat or cure hypertension.7 Recognition of the hypertensinogenic factors may allow nonpharmacological prevention, treatment, or cure of hypertension. Hypertensinogenic factors such as obesity, insulin resistance, or high alcohol intake also have an important genetic component. Furthermore, there are interactions between genetic and environmental factors (Figure 2) that influence intermediary phenotypes such as sympathetic nerve activity, the renin-angiotensin-aldosterone and renal kallikrein-kinin systems, and endothelial factors, which in turn influence other intermediary phenotypes such as sodium excretion, vascular reactivity, and cardiac contractility. These and many other intermediary phenotypes determine total vascular resistance and cardiac output and, consequently, BP. Recognition of the hypertensinogenic factor(s) and establishing that the patient's hypertension is the result of obesity (either alone or combined with other factors such as insulin resistance or high alcohol intake) or old age instead of essential hypertension may help the physician as well as the patient and his or her family to modify or eliminate these hypertensinogenic and CVD risk factors when possible, which may cure the hypertension or at least facilitate control of BP. When the hypertensinogenic factor cannot be reduced or eliminated, as with systolic hypertension induced by aging (arteriosclerosis), recognition of the underlying cause of high BP will emphasize the need for (1) further studies to determine whether the patient has arteriosclerosis and/or atherosclerosis, the magnitude of the disease, and whether there are occlusive lesions; (2) treatment of the atherosclerosis with lifestyle and dietary changes and lipid-lowering agents if necessary; and (3) pharmacological treatment of systolic hypertension to decrease passive stiffness (arteriosclerosis) of the major central elastic arteries and decrease morbidity and mortality rates. Thus recognition of factors that induce hypertension is not only of theoretical but also of practical importance. In conclusion, as stated by Beilin,8 "it is no longer appropriate to define essential hypertension as a rise in blood pressure without cause," since a number of causes can be clearly identified in most cases of so-called "essential hypertension." As discussed later in more detail, there is clear evidence that changes in lifestyle, including dietary changes that reduce body weight, fat, and alcohol intake and increase potassium and calcium intake,9 as well as exercise,1011 reduce or normalize BP in many patients. Inherited BPThe identification of variant (allelic) genes that contribute to the development of hypertension is complicated by the fact that the 2 phenotypes that determine BP, cardiac output and total peripheral resistance, are controlled by intermediary phenotypes, including the autonomic nervous system, vasopressor/vasodepressor hormones, the structure of the cardiovascular system, body fluid volume and renal function, and many others. Furthermore, these intermediary phenotypes are also controlled by complex mechanisms including BP itself.12 Thus there are many genes that could participate in the development of hypertension. The influence of genes on BP has been suggested by family studies demonstrating associations of BP among siblings and between parents and children. There is a better association among BP values in biological children than in adopted children and in identical as opposed to nonidentical twins. BP variability attributed to all genetic factors varies from 25% in pedigree studies to 65% in twin studies. Furthermore, genetic factors also influence behavioral patterns, which might lead to BP elevation. For example, a tendency toward obesity or alcoholism will be influenced by both genetic and environmental factors; thus the proportion of BP variability caused by inheritance is difficult to determine and may vary in different populations. Mutations in at least 10 genes have been shown to raise or lower BP through a common pathway by increasing or decreasing salt and water reabsorption by the nephron.1314 The genetic mutations responsible for 3 rare forms of mendelian (monogenic) hypertensive syndromes−glucocorticoid-remediable aldosteronism (GRA), Liddle's syndrome, and apparent mineralocorticoid excess−have been identified, whereas in a fourth, autosomal dominant hypertension with brachydactyly, the gene is not yet identified but has been mapped to chromosome 12 (12p). Subtle variations in one of these genes may also cause some forms of "essential" hypertension. For a review of the mutations that cause a decrease in BP, see Lifton.13Glucocorticoid-Remediable AldosteronismThis is an autosomal dominant form of monogenic hypertension in which aldosterone secretion is regulated by adrenocorticotropic hormone. Glucocorticoid treatment causes BP to decrease and gives the syndrome its name. The genetic mutation that causes GRA has been identified by Lifton14 as a chimeric gene fusing nucleotide sequences of the promoter-regulatory region of 11β-hydroxylase (controlled by adrenocorticotropic hormone) and the structural portion of the aldosterone synthase gene. The chimeric gene results from a meiotic mismatch and unequal crossing over. The patients are usually thought to have primary aldosteronism because they exhibit volume expansion, metabolic alkalosis with hypokalemia, low plasma renin, and high aldosterone. Most of the patients first described as having GRA showed severe hypertension and died prematurely from stroke. However, with the development of direct genetic testing, the BP of patients with this syndrome was found to cover a wide range, including normotensive levels.1516 In patients with GRA and normal BP, expression of the chimeric gene may be variable, but because steroid levels are similar in patients with severe and mild hypertension, this seems unlikely. It is also possible that the genetic background of the trait (other than the chimeric mutation), such as high renal kallikrein, places the inherited BP of these subjects in the low or ideal normal range and the mutation causes BP to increase to high normal or hypertensive stage 1. Thus the final BP would be the combined result of the inherited BP (including the genetic mutation) and the increase in BP caused by hypertensinogenic factors such as salt. Liddle's SyndromeThis is an autosomal dominant form of monogenic hypertension that results from mutations in the amiloride-sensitive epithelial sodium channel, leading to increased channel activity.17 The mutations reported to date result in the elimination of 45 to 75 amino acids from the cytoplasmic carboxyl terminus of β- or γ-subunits of the channel; thus Liddle's syndrome is genetically heterogeneous. It is characterized by the early onset of hypertension with hypokalemia and suppression of both plasma renin activity and aldosterone, the latter differentiating this syndrome from primary aldosteronism. Both the hypertension and the hypokalemia vary in severity, raising the possibility that some patients classified as having salt-sensitive essential hypertension actually have Liddle's syndrome.18 It is also possible that high BP in blacks, who are frequently salt-sensitive, is due to a polymorphism in one of the sodium channel genes or in one of the genes of systems that regulate it, causing its activity to increase. Apparent Mineralocorticoid ExcessThis is an autosomal recessive form of monogenic juvenile hypertension that results from a mutation in the renal-specific isoform 11β-hydroxysteroid dehydrogenase gene.19 Normally this enzyme converts cortisol to the inactive metabolite cortisone. In the distal nephron this is important because cortisol and aldosterone have a similar affinity for the mineralocorticoid receptor. The enzymatic deficiency allows the mineralocorticoid receptors in the nephron to be occupied and activated by cortisol, causing sodium and water retention, volume expansion, low renin, low aldosterone, and more importantly, a salt-sensitive form of hypertension. Thus this gene may be a locus for salt-sensitive essential hypertension. Autosomal Dominant Hypertension With BrachydactylyIn this monogenic syndrome, hypertension and brachydactyly are always inherited together (100% cosegregation).4 Affected persons are shorter than nonaffected relatives. The gene for hypertension has been mapped to the short arm of chromosome 12 (12p) in a large Turkish kindred. Two other families with this syndrome have been reported, 1 in Canada and 1 in the United States. In addition, the study of a Japanese child with hypertension and type E brachydactyly has allowed the area on 12p containing the gene mutation to be pinpointed further, although the gene responsible for this syndrome has not yet been cloned. Unlike the other 3 autosomal forms of hypertension, BP is not affected by volume expansion and the underlying mechanism is not known. Thus identification of the gene responsible may help clarify some of the genetic alterations in essential hypertension. Essential or Primary HypertensionThe genetic alterations responsible for inherited "essential" hypertension remain largely unknown.4 Results from family studies suggest several possible intermediary phenotypes (genetic traits) that may be related to inherited high BP, such as high sodium-lithium countertransport, low urinary kallikrein excretion, high fasting plasma insulin concentrations, high-density LDL subfractions, fat pattern index, and body mass index (BMI).12 Jeunemaitre et al2021 first reported a polymorphism in the angiotensinogen gene linked with essential hypertension in hypertensive siblings from Utah and France. This polymorphism consists of a substitution of thymidine for cytosine in nucleotide 704, which causes substitution of methionine for threonine at position 235 (M235T) and is associated with increased concentrations of plasma angiotensinogen. This variant appears to be in tight linkage disequilibrium with a promoter mutation in which adenine replaces guanine (-6A) upstream from the initiation side of transcription.22 Tests of promoter activity suggest that this nucleotide substitution increases the rate of gene transcription, which may explain the higher angiotensinogen concentration found in subjects with the variant M235T.22 Many studies have been published on various racial groups with regard to the association between allelic variations in angiotensinogen and hypertension.23 However, these variations explain only a small part of the BP variation (≈6%). Furthermore, plasma angiotensinogen concentrations, though higher in patients with the polymorphism, clearly overlap with normotensive patients. Polymorphisms and mutations in other genes such as angiotensin-converting enzyme, β2-adrenergic receptor, α-adducin, angiotensinase C, renin-binding protein, G-protein β3-subunit, atrial natriuretic factor, and the insulin receptor have also been linked to the development of essential hypertension; however, most of them show a weak association if any, and most of these studies need further confirmation. Thus these gene alterations will not be discussed here because they go beyond the scope of this review (see Luft4 ).Hypertensinogenic FactorsThere is evidence that obesity, insulin resistance, high alcohol intake, high salt intake, a sedentary lifestyle, stress, dyslipidemia, and low potassium or calcium intake increase BP in susceptible subjects. Here we will briefly discuss obesity and insulin resistance; other hypertensinogenic factors will be discussed in the section "Lifestyle Modification."Obesity and Insulin ResistanceObesity, and obesity, is the main hypertensinogenic It was estimated in the study that is associated with a mm Hg increase in systolic is also the cause of insulin resistance, left and Thus obesity is an important cardiovascular its incidence and prevalence are in most industrialized and in the United States has The between BP and body fat is not to the but is continuous throughout the range of body A direct association between hypertension and in by the in has been in and population studies from early to old A of is considered normal or whereas a of to with increases the risk of high BP by and the risk of insulin resistance by Thus insulin resistance is in many patients with obesity and hypertension. The mechanism by which obesity BP is not but increased is associated with an increase in plasma volume and cardiac both these alterations and BP can be by in both normotensive and hypertensive even when sodium intake is BP in is and fasting insulin is the of this In these BP by 10 mm Hg changing from 2 on a to a When some of these subjects by BP by 10 mm Hg and salt was no longer present. The that sodium fasting plasma plasma aldosterone, and plasma the that BP is to dietary sodium and that this may be due to the combined of and increased activity of the sympathetic nervous It is not clear whether body fat by is a factor because in for 1 3 BP, and this decrease was mainly in those who high fasting insulin and insulin levels in to In this study was not a factor because the subjects on a and actually gained an average of the which that plasma insulin by a different mechanism than of body These studies can be as that high plasma insulin causes salt and that decreasing insulin resistance by or BP. Furthermore, hypertensive subjects are more to exhibit insulin resistance than normotensive the other insulin by has a In subjects with hypertension there is resistance to the of insulin on However, in addition to this metabolic insulin increases both sympathetic nerve activity and sodium and water retention, and it could be that the hypertension is due to the of resistance to these secondary of factor and a that have also been in the of hypertension. although the mechanisms by which obesity and insulin resistance increase BP remain it is clear that these increases in BP are on the inherited of of the evaluation are to determine the and of target organ and for specific causes of hypertension hypertensinogenic factors and other CVD risk factors; and the patient to facilitate the of therapy and define and of BP by the is the most important part of the evaluation and of the patient and be in a 2) with the use of and A is a or a to an arm Two or 3 measurements be at and at least 2 be allowed between The diastolic is at the level when of BP by patients or family and/or BP the diagnosis and the of hypertension. BP values the are lower and better with target organ than BP measurements by of BP has several including hypertension from hypertension that only in the the to antihypertensive to treatment by the patient a in his or her and by the need for BP or of BP is for many patients with high BP, those who to be to antihypertensive A of or BP measurements is that and BP be and that and in to BP be and be and a in all patients The assessment the described in Table It help to known, causes of high the or of target organ and and other CVD or comorbid conditions that might or Tests and only blood blood fasting total and high-density or and a indicated in patients for the diagnosis of secondary hypertension and/or comorbid conditions urinary protein, of fasting and plasma renin is Part of a Part of this will be published in the 1, of 1. of hypertensinogenic factors such as obesity and alcohol intake on systolic and diastolic BP the stage of inherited BP to without the of the hypertensinogenic with normal or high normal inherited BP hypertensive stage 1 when BP is increased by a hypertensinogenic In patients with inherited hypertension in 1 to hypertension more severe when hypertensinogenic factors are among genetic and environmental factors in the development of hypertension. side of environmental factors and multiple genes responsible for high BP and intermediary The result of these intermediary phenotypes is blood pressure with a normal distribution skewed to the right. the theoretical BP of the population that is not affected by hypertensinogenic factors; area systolic BP in the hypertensive range. and dotted populations in which 1 or 2 hypertensinogenic factors high alcohol intake) have been that in these 2 populations the distribution are to the right and the number of hypertensive individuals is increased when hypertensinogenic factors are Table 1. and of Blood Pressure mm mm 1 2 3 systolic a patient's systolic and

Circulation · review · 1085 citationsread the source →

The utilization of advance telemetry to investigate critical physiological parameters including electroencephalography in cynomolgus macaques following aerosol challenge with eastern equine encephalitis virus.

Most alphaviruses are mosquito-borne and can cause severe disease in humans and domesticated animals. In North America, eastern equine encephalitis virus (EEEV) is an important human pathogen with case fatality rates of 30-90%. Currently, there are no therapeutics or vaccines to treat and/or prevent human infection. One critical impediment in countermeasure development is the lack of insight into clinically relevant parameters in a susceptible animal model. This study examined the disease course of EEEV in a cynomolgus macaque model utilizing advanced telemetry technology to continuously and simultaneously measure temperature, respiration, activity, heart rate, blood pressure, electrocardiogram (ECG), and electroencephalography (EEG) following an aerosol challenge at 7.0 log10 PFU. Following challenge, all parameters were rapidly and substantially altered with peak alterations from baseline ranged as follows: temperature (+3.0-4.2°C), respiration rate (+56-128%), activity (-15-76% daytime and +5-22% nighttime), heart rate (+67-190%), systolic (+44-67%) and diastolic blood pressure (+45-80%). Cardiac abnormalities comprised of alterations in QRS and PR duration, QTc Bazett, T wave morphology, amplitude of the QRS complex, and sinoatrial arrest. An unexpected finding of the study was the first documented evidence of a critical cardiac event as an immediate cause of euthanasia in one NHP. All brain waves were rapidly (~12-24 hpi) and profoundly altered with increases of up to 6,800% and severe diffuse slowing of all waves with decreases of ~99%. Lastly, all NHPs exhibited disruption of the circadian rhythm, sleep, and food/fluid intake. Accordingly, all NHPs met the euthanasia criteria by ~106-140 hpi. This is the first of its kind study utilizing state of the art telemetry to investigate multiple clinical parameters relevant to human EEEV infection in a susceptible cynomolgus macaque model. The study provides critical insights into EEEV pathogenesis and the parameters identified will improve animal model development to facilitate rapid evaluation of vaccines and therapeutics.

PLoS neglected tropical diseases · 10 citationsread the source →

Prenatal exposure to bisphenol A and child wheeze from birth to 3 years of age.

Background: Bisphenol A (BPA), an endocrine-disrupting chemical that is routinely detected in > 90% of Americans, promotes experimental asthma in mice. The association of prenatal BPA exposure and wheeze has not been evaluated in humans. Objective: We examined the relationship between prenatal BPA exposure and wheeze in early childhood. Methods: We measured BPA concentrations in serial maternal urine samples from a prospective birth cohort of 398 mother-infant pairs and assessed parent-reported child wheeze every 6 months for 3 years. We used generalized estimating equations with a logit link to evaluate the association of prenatal urinary BPA concentration with the dichotomous outcome wheeze (wheeze over the previous 6 months). Results: Data were available for 365 children; BPA was detected in 99% of maternal urine samples during pregnancy. In multivariable analysis, a one-unit increase in log-transformed creatinine-standardized mean prenatal urinary BPA concentration was not significantly associated with child wheeze from birth to 3 years of age, but there was an interaction of BPA concentration with time (p = 0.003). Mean prenatal BPA above versus below the median was positively associated with wheeze at 6 months of age [adjusted odds ratio (AOR) = 2.3; 95% confidence interval (CI): 1.3, 4.1] but not at 3 years (AOR = 0.6; 95% CI: 0.3, 1.1). In secondary analyses evaluating associations of each prenatal BPA concentration separately, urinary BPA concentrations measured at 16 weeks gestation were associated with wheeze (AOR = 1.2; 95% CI: 1.0, 1.5), but BPA concentrations at 26 weeks of gestation or at birth were not. Conclusions: Mean prenatal BPA was associated with increased odds of wheeze in early life, and the effect diminished over time. Evaluating exposure at each prenatal time point demonstrated an association between wheeze from 6 months to 3 years and log-transformed BPA concentration at 16 weeks gestation only.

Environmental health perspectives · 96 citationsread the source →

Trial of a patient-directed eHealth program to ameliorate perinatal depression: the MomMoodBooster2 practical effectiveness study.

Background: Depression is one of the most common complications of childbirth, and is experienced by approximately 17% of pregnant women and 13% of postpartum women. An estimated 85% of these women go untreated-an alarming statistic given the serious consequences for the mother, her child, other family members, and society. Professional societies (the American College of Obstetricians and Gynecologists and American Academy of Pediatrics) have recommended improvements in screening and treatment. Meta-analyses indicate that cognitive behavioral therapy eHealth interventions are efficacious for depression, generally, and for perinatal depression, specifically. Earlier controlled trials have established the effectiveness and acceptability of MomMoodBooster (including an Australian version, MumMoodBooster), an eHealth program for ameliorating postpartum depression. Objective: This study aimed to evaluate the effectiveness of a perinatal version of MomMoodBooster encompassing both prenatal and postpartum content in a healthcare delivery setting already providing universal screening and referral of at-risk patients as part of routine care. Study design: A practical effectiveness study randomly assigned 95 pregnant and 96 postpartum women screened as depressed and satisfying eligibility criteria to experimental groups: the healthcare organization's perinatal depression care program (routine-care group) and routine care+MomMoodBooster2 program (eHealth group). Eligibility criteria included: pregnant or <1 year postpartum, ≥18 years of age, no active suicidal ideation, access to broadband internet via desktop/laptop, tablet, or smartphone, and English language proficiency. Results: Intent-to-treat analyses of group effects used fixed-effects growth models to assess 12-week posttest change in outcomes. Results showed that both groups had significantly decreased depression severity, anxiety, stress, and automatic thoughts, and increased behavioral activation and self-efficacy. Relative to the routine-care group, the eHealth group displayed significantly greater decreases in depression severity and stress. These group comparisons were not moderated by depression severity (screening or baseline), anxiety, stress, or pregnant/postpartum status. Almost all (93%; n=89) women in the eHealth group visited their program, of whom 99% visited program sessions (M sessions visited=4.3±2.0; M total session duration=73.0±70.2 minutes; 49% viewed all 6 sessions). Among confirmed eHealth program users who provided ratings, 96% (79/82) rated their program as easy to use, 83% rated it helpful, and 93% (76/82) indicated that they would recommend it. Conclusion: Results support the effectiveness of using MomMoodBooster2 as a treatment option for perinatal women with depression, especially when combined with universal depression screening and referral. Consequently, the eHealth program shows promise as a tool to increase the reach of treatment delivery and to potentially reduce the number of untreated perinatal women with depression.

American journal of obstetrics and gynecology · 16 citationsread the source →

Acceptability and Preliminary Effects of a Mindfulness Mobile Application for Ruminative Adolescents.

Rumination is a transdiagnostic risk factor that appears to be reduced through mindfulness interventions. However, mindfulness mobile apps have not been tested for their effects on rumination, especially among adolescents. Thus, we aimed to test the acceptability and effects of a mindfulness mobile intervention among ruminative adolescents using a within-subjects pretest/posttest design. Participants were 80 adolescents ages 12-15, selected for moderate-to-high rumination (M age = 14.01, SD = .99; 46.2% girls; 86.25% White; 3.75% Hispanic). We asked adolescents to use our mindfulness app 3 times per day for 3 weeks. Participants and parents completed questionnaires at baseline, post-intervention, and 6 and 12 weeks later. Acceptability was assessed by tracking app use and asking adolescents and parents to report on their experiences post-intervention. We assessed repetitive negative thinking (i.e., rumination and worry) and internalizing symptoms via self- and parent-report. The intervention demonstrated acceptability, and there were significant reductions in rumination, worry, anxiety and parent-reported internalizing symptoms post-intervention. Effects on rumination, anxiety and internalizing symptoms persisted throughout the 12-week follow-up with large effect sizes using an intention-to-treat approach. Thus, a brief mindfulness mobile app intervention appeared to be both engaging and helpful in reducing negative repetitive thinking and internalizing symptoms among ruminative adolescents. It will be important to test this intervention in a randomized controlled trial to control for effects of time and attention.

Behavior therapy · 18 citationsread the source →

Gender gap in health service utilisation and outcomes of depression: A cross-country longitudinal analysis of European middle-aged and older adults.

Research has shown that health service utilisation for depression (HSUD) is less common among men than women. However, most evidence is cross-sectional, and there is limited information about gendered outcomes of depression. This cross-country study assesses gender differences in HSUD and in the persistence of depression by using cross-sectional and longitudinal data. We used data from the Survey of Health, Ageing and Retirement in Europe (SHARE), from 5428 participants between 50 and 80 from nine European countries, fulfilling criteria for depression in Wave 5 (assessed by the EURO-D depression scale). We modelled non-HSUD among all those depressed in Wave 5 ("cross-sectional data") and those not depressed in Wave 4 ("longitudinal data"), and the persistence of depression in Wave 6, as a function of gender. We used logistic regressions adjusted for age, marital status, country, education, financial strain, and severity of depression. Non-HSUD was more likely among depressed men than women in both cross-sectional (82.4% vs 73.2%, OR = 1.54, 99%CI = 1.54-1.55) and longitudinal analyses (94.4% vs 88.3%, OR = 2.27, 99%CI = 2.25-2.29). Gender differences were greater among low-educated participants and those with less pronounced financial strain. Among those with HSUD, men were more likely to remain depressed (62.3%, OR = 2.26, 99%CI = 2.22-2.30). Among those without HSUD, depression was more likely to persist among women (45.4%, OR = 0.79, 99%CI = 0.78-0.79). Results suggest that cross-sectional analyses underestimate men's disadvantage in HSUD. Interventions are needed to improve the demand for care and treatment adequacy among men, increasing their perception of need and their mental health literacy.

Preventive medicine · 13 citationsread the source →

Depressive symptoms and objectively measured physical activity and sedentary behaviour throughout adolescence: a prospective cohort study.

Background: Identifying modifiable risk factors is essential to reduce the prevalence adolescent depression. Self-report data suggest that physical activity and sedentary behaviour might be associated with depressive symptoms in adolescents. We examined associations between depressive symptoms and objectively measured physical activity and sedentary behaviour in adolescents. Methods: From a population-based cohort of adolescents whose mothers were invited to participate in the Avon Longitudinal Study of Parents and Children (ALSPAC) study, we included participants with at least one accelerometer recording and a Clinical Interview Schedule-Revised (CIS-R) depression score at age 17·8 years (reported as age 18 years hereafter). Amounts of time spent in sedentary behaviour and physical activity (light or moderate-to-vigorous) were measured with accelerometers at around 12 years, 14 years, and 16 years of age. Total physical activity was also recorded as count per minute (CPM), with raw accelerometer counts averaged over 60 s epochs. Associations between the physical activity and sedentary behaviour variables and depression (CIS-R) scores at age 18 years were analysed with regression and group-based trajectory modelling. Findings: 4257 adolescents from the 14 901 enrolled in the ALSPAC study had a CIS-R depression score at age 18 years. Longitudinal analyses included 2486 participants at age 12 years, 1938 at age 14 years, and 1220 at age 16 years. Total follow-up time was 6 years. Total physical activity decreased between 12 years and 16 years of age, driven by decreasing durations of light activity (mean 325·66 min/day [SD 58·09] at 12 years; 244·94 min/day [55·08] at 16 years) and increasing sedentary behaviour (430·99 min/day [65·80]; 523·02 min/day [65·25]). Higher depression scores at 18 years were associated with a 60 min/day increase in sedentary behaviour at 12 years (incidence rate ratio [IRR] 1·111 [95% CI 1·051-1·176]), 14 years (1·080 [1·012-1·152]), and 16 years of age (1·107 [1·015-1·208]). Depression scores at 18 years were lower for every additional 60 min/day of light activity at 12 years (0·904 [0·850-0·961]), 14 years (0·922 [0·857-0·992]), and 16 years of age (0·889 [0·809-0·974]). Group-based trajectory modelling across 12-16 years of age identified three latent subgroups of sedentary behaviour and activity levels. Depression scores were higher in those with persistently high (IRR 1·282 [95% CI 1·061-1·548]) and persistently average (1·249 [1·078-1·446]) sedentary behaviour compared with those with persistently low sedentary behaviour, and were lower in those with persistently high levels of light activity (0·804 [0·652-0·990]) compared with those with persistently low levels of light activity. Moderate-to-vigorous physical activity (per 15 min/day increase) at age 12 years (0·910 [0·857-0·966]) and total physical activity (per 100 CPM increase) at ages 12 years (0·941 [0·910-0·972]) and 14 years (0·965 [0·932-0·999]), were negatively associated with depressive symptoms. Interpretation: Sedentary behaviour displaces light activity throughout adolescence, and is associated with a greater risk of depressive symptoms at 18 years of age. Increasing light activity and decreasing sedentary behaviour during adolescence could be an important target for public health interventions aimed at reducing the prevalence of depression. Funding: Details of funding are provided in the Acknowledgments.

The lancet. Psychiatry · 211 citationsread the source →

Comprehensive Health Assessment 3 Months After Recovery From Acute Coronavirus Disease 2019 (COVID-19).

Background: Long-term health sequelae of coronavirus disease 2019 (COVID-19) may be multiple but have thus far not been systematically studied. Methods: All patients discharged after COVID-19 from the Radboud University Medical Center, Nijmegen, the Netherlands, were consecutively invited to a multidisciplinary outpatient facility. Also, nonadmitted patients with mild disease but with symptoms persisting >6 weeks could be referred by general practitioners. Patients underwent a standardized assessment including measurements of lung function, chest computed tomography (CT)/X-ray, 6-minute walking test, body composition, and questionnaires on mental, cognitive, health status, and quality of life (QoL). Results: 124 patients (59 ± 14 years, 60% male) were included: 27 with mild, 51 with moderate, 26 with severe, and 20 with critical disease. Lung diffusion capacity was below the lower limit of normal in 42% of discharged patients. 99% of discharged patients had reduced ground-glass opacification on repeat CT imaging, and normal chest X-rays were found in 93% of patients with mild disease. Residual pulmonary parenchymal abnormalities were present in 91% of discharged patients and correlated with reduced lung diffusion capacity. Twenty-two percent had low exercise capacity, 19% low fat-free mass index, and problems in mental and/or cognitive function were found in 36% of patients. Health status was generally poor, particularly in the domains functional impairment (64%), fatigue (69%), and QoL (72%). Conclusions: This comprehensive health assessment revealed severe problems in several health domains in a substantial number of ex-COVID-19 patients. Longer follow-up studies are warranted to elucidate natural trajectories and to find predictors of complicated long-term trajectories of recovery.

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 334 citationsread the source →

Mind-Body Skills Training for Resident Wellness: A Pilot Study of a Brief Mindfulness Intervention.

Background: Interventions to address burnout include mind-body skills training (MBST), but few studies have evaluated the feasibility of MBST for busy pediatric residents. Objective: In this pilot study, we tested the feasibility of a brief MBST intervention, using in-person peer-led training supported by online modules, to decrease stress and burnout in pediatric resident physicians. Methods: Of 99 (10%) residents, 10 residents at Nationwide Children's Hospital in Ohio participated in up to four 90-minute MBST sessions more than 1 month, led by a co-resident with 5 years of informal training in mind-body skills. Participants were offered 8 assigned online modules through OSU Center for Integrative Health and Wellness. Measures including Maslach Burnout Inventory (MBI), Cohen's Perceived Stress, Smith's Brief Resilience, Cognitive and Affective Mindfulness Scale-Revised, and Neff's Self-Compassion Scale (NSS) were administered before (T1) and after (T2) the course. Participants were offered optional monthly "maintenance" sessions for 6 months and completed a third set of measures at this follow-up (T3). Results: The residents completed an average of 4.3/8 online modules and attended an average of 2.8/4 in-person sessions. There was significant improvement in positive attitude, perceived stress, and resilience post intervention (T2). Follow-up evaluation (T3) also demonstrated significant improvement in burnout (depersonalization) and mindfulness. More than 75% of participants found the course worthwhile. Conclusions: A short mixed-method mindfulness-based skills course may be a practical way to offer resilience and stress management training to busy resident physicians.

Journal of medical education and curricular development · 30 citationsread the source →

Migration and risk of HIV acquisition in Rakai, Uganda: a population-based cohort study.

Background: In sub-Saharan Africa, migrants typically have higher HIV prevalence than non-migrants; however, whether HIV acquisition typically precedes or follows migration is unknown. We aimed to investigate the risk of HIV after migration in Rakai District, Uganda. Methods: In a prospective population-based cohort of HIV-negative participants aged 15-49 years in Rakai, Uganda, between April 6, 1999, and Jan 30, 2015, we assessed the association between migration and HIV acquisition. Individuals were classified as recent in-migrants (≤2 years in community), non-recent in-migrants (>2 years in community), or permanent residents with no migration history. The primary outcome was incident HIV infection. We used Poisson regression to estimate incidence rate ratios (IRRs) of HIV associated with residence status with adjustment for demographics, sexual behaviours, and time. Data were also stratified and analysed within three periods (1999-2004, 2005-11, and 2011-15) in relation to the introduction of combination HIV prevention (CHP; pre-CHP, early CHP, and late CHP). Findings: Among 26 995 HIV-negative people who participated in the Rakai Community Cohort Study survey, 15 187 (56%) contributed one or more follow-up visits (89 292 person-years of follow-up) and were included in our final analysis. 4451 (29%) were ever in-migrants and 10 736 (71%) were permanent residents. 841 incident HIV events occurred, including 243 (29%) among in-migrants. HIV incidence per 100 person-years was significantly increased among recent in-migrants compared with permanent residents, for both women (1·92, 95% CI 1·52-2·43 vs 0·93, 0·84-1·04; IRR adjusted for demographics 1·75, 95% CI 1·33-2·33) and men (1·52, 0·99-2·33 vs 0·84, 0·74-0·94; 1·74, 1·12-2·71), but not among non-recent in-migrants (IRR adjusted for demographics 0·94, 95% CI 0·74-1·19 for women and 1·28, 0·94-1·74 for men). Between the pre-CHP and late-CHP periods, HIV incidence declined among permanent resident men (p<0·0001) and women (p=0·002) and non-recent in-migrant men (p=0·031), but was unchanged among non-recent in-migrant women (p=0·13) and recent in-migrants (men p=0·76; women p=0·84) INTERPRETATION: The first 2 years after migration are associated with increased risk of HIV acquisition. Prevention programmes focused on migrants are needed to reduce HIV incidence in sub-Saharan Africa. Funding: National Institute of Mental Health, the National Institute of Allergy and Infectious Diseases, the National Institute of Child Health and Development, the National Institute for Allergy and Infectious Diseases Division of Intramural Research, National Institutes of Health; the Centers for Disease Control and Prevention; the Bill & Melinda Gates Foundation; and the Johns Hopkins University Center for AIDS Research.

The lancet. HIV · 83 citationsread the source →

Association of Short and Long Sleep Duration With Amyloid-β Burden and Cognition in Aging.

Importance: Disrupted sleep is common in aging and is associated with cognition. Age-related changes to sleep are associated with multiple causes, including early Alzheimer disease pathology (amyloid β [Aβ]), depression, and cardiovascular disease. Objective: To investigate the associations between self-reported sleep duration and brain Aβ burden as well as the demographic, cognitive, and lifestyle variables in adults with normal cognition. Design, setting, and participants: This cross-sectional study obtained data from participants in the Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4) study, which is being conducted in 67 sites in the United States, Canada, Australia, and Japan. The sample for this analysis consisted of individuals aged 65 to 85 years who underwent an Aβ positron emission tomography (PET) scan, had complete apolipoprotein E (APOE) genotype data, and were identified as clinically normal (per a Clinical Dementia Rating score of 0) and cognitively unimpaired (per a Mini-Mental State Examination score of 25 to 30 and Logical Memory Delayed Recall test score of 6 to 18). Data were analyzed from April 3, 2020, to June 20, 2021. Main outcomes and measures: The outcome was self-reported nightly sleep duration (grouped by short sleep duration: ≤6 hours, normal sleep duration: 7-8 hours, and long sleep duration: ≥9 hours) compared with demographic characteristics, Aβ burden (as measured with a fluorine 18-labeled-florbetapir PET scan), objective and subjective cognitive function measures, and lifestyle variables. Results: The 4417 participants in the study included 2618 women (59%) and had a mean (SD) age of 71.3 (4.7) years. Self-reported shorter sleep duration was linearly associated with higher Aβ burden (β [SE] = -0.01 [0.00]; P = .005), and short sleep duration was associated with reduced cognition that was mostly in memory domains. No difference in Aβ was found between long and normal sleep duration groups (β [SE] = 0.00 [0.01]; P = .99). However, compared with normal sleep duration, both short and long sleep durations were associated with higher body mass index (short vs normal sleep duration: β [SE] = 0.48 [0.17], P = .01; long vs normal sleep duration: β [SE] = 0.97 [0.31], P = .002), depressive symptoms (short vs normal sleep duration: β [SE] = 0.31 [0.05], P < .001; long vs normal sleep duration: β [SE] = 0.39 [0.09], P < .001), and daytime napping (short vs normal sleep duration: β [SE] = 2.66 [0.77], P = .001; long vs normal sleep duration: β [SE] = 3.62 [1.38], P = .01). Long sleep duration was associated with worse performance across multiple cognitive domains. Conclusions and relevance: In this cross-sectional study, both short and long sleep durations were associated with worse outcomes for older adults, such as greater Aβ burden, greater depressive symptoms, higher body mass index, and cognitive decline, emphasizing the importance of maintaining adequate sleep.

JAMA neurology · 219 citationsread the source →

Contribution of risk factors to excess mortality in isolated and lonely individuals: an analysis of data from the UK Biobank cohort study.

Background: The associations of social isolation and loneliness with premature mortality are well known, but the risk factors linking them remain unclear. We sought to identify risk factors that might explain the increased mortality in socially isolated and lonely individuals. Methods: We used prospective follow-up data from the UK Biobank cohort study to assess self-reported isolation (a three-item scale) and loneliness (two questions). The main outcomes were all-cause and cause-specific mortality. We calculated the percentage of excess risk mediated by risk factors to assess the extent to which the associations of social isolation and loneliness with mortality were attributable to differences between isolated and lonely individuals and others in biological (body-mass index, systolic and diastolic blood pressure, and handgrip strength), behavioural (smoking, alcohol consumption, and physical activity), socioeconomic (education, neighbourhood deprivation, and household income), and psychological (depressive symptoms and cognitive capacity) risk factors. Findings: 466 901 men and women (mean age at baseline 56·5 years [SD 8·1]) were included in the analyses, with a mean follow-up of 6·5 years (SD 0·8). The hazard ratio for all-cause mortality for social isolation compared with no social isolation was 1·73 (95% CI 1·65-1·82) after adjustment for age, sex, ethnic origin, and chronic disease (ie, minimally adjusted), and was 1·26 (95% CI 1·20-1·33) after further adjustment for socioeconomic factors, health-related behaviours, depressive symptoms, biological factors, cognitive performance, and self-rated health (ie, fully adjusted). The minimally adjusted hazard ratio for mortality risk related to loneliness was 1·38 (95% CI 1·30-1·47), which reduced to 0·99 (95% CI 0·93-1·06) after full adjustment for baseline risks. Interpretation: Isolated and lonely people are at increased risk of death. Health policies addressing risk factors such as adverse socioeconomic conditions, unhealthy lifestyle, and lower mental wellbeing might reduce excess mortality among the isolated and the lonely. Funding: Academy of Finland, NordForsk, and the UK Medical Research Council.

The Lancet. Public health · 295 citationsread the source →

Inflammation, But Not Telomere Length, Predicts Successful Ageing at Extreme Old Age: A Longitudinal Study of Semi-supercentenarians.

To determine the most important drivers of successful ageing at extreme old age, we combined community-based prospective cohorts: Tokyo Oldest Old Survey on Total Health (TOOTH), Tokyo Centenarians Study (TCS) and Japanese Semi-Supercentenarians Study (JSS) comprising 1554 individuals including 684 centenarians and (semi-)supercentenarians, 167 pairs of centenarian offspring and spouses, and 536 community-living very old (85 to 99 years). We combined z scores from multiple biomarkers to describe haematopoiesis, inflammation, lipid and glucose metabolism, liver function, renal function, and cellular senescence domains. In Cox proportional hazard models, inflammation predicted all-cause mortality with hazard ratios (95% CI) 1.89 (1.21 to 2.95) and 1.36 (1.05 to 1.78) in the very old and (semi-)supercentenarians, respectively. In linear forward stepwise models, inflammation predicted capability (10.8% variance explained) and cognition (8(.)6% variance explained) in (semi-)supercentenarians better than chronologic age or gender. The inflammation score was also lower in centenarian offspring compared to age-matched controls with Δ (95% CI) = - 0.795 (- 1.436 to - 0.154). Centenarians and their offspring were able to maintain long telomeres, but telomere length was not a predictor of successful ageing in centenarians and semi-supercentenarians. We conclude that inflammation is an important malleable driver of ageing up to extreme old age in humans.

EBioMedicine · 227 citationsread the source →

Primal world beliefs.

Beck's insight-that beliefs about one's self, future, and environment shape behavior-transformed depression treatment. Yet environment beliefs remain relatively understudied. We introduce a set of environment beliefs-primal world beliefs or primals-that concern the world's overall character (e.g., the world is interesting, the world is dangerous). To create a measure, we systematically identified candidate primals (e.g., analyzing tweets, historical texts, etc.); conducted exploratory factor analysis (N = 930) and two confirmatory factor analyses (N = 524; N = 529); examined sequence effects (N = 219) and concurrent validity (N = 122); and conducted test-retests over 2 weeks (n = 122), 9 months (n = 134), and 19 months (n = 398). The resulting 99-item Primals Inventory (PI-99) measures 26 primals with three overarching beliefs-Safe, Enticing, and Alive (mean α = .93)-that typically explain ∼55% of the common variance. These beliefs were normally distributed; stable (2 weeks, 9 months, and 19 month test-retest results averaged .88, .75, and .77, respectively); strongly correlated with many personality and wellbeing variables (e.g., Safe and optimism, r = .61; Enticing and depression, r = -.52; Alive and meaning, r = .54); and explained more variance in life satisfaction, transcendent experience, trust, and gratitude than the BIG 5 (3%, 3%, 6%, and 12% more variance, respectively). In sum, the PI-99 showed strong psychometric characteristics, primals plausibly shape many personality and wellbeing variables, and a broad research effort examining these relationships is warranted. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Psychological assessment · 48 citationsread the source →

Roles of cyberbullying, sleep, and physical activity in mediating the effects of social media use on mental health and wellbeing among young people in England: a secondary analysis of longitudinal data.

Background: There is growing concern about the potential associations between social media use and mental health and wellbeing in young people. We explored associations between the frequency of social media use and later mental health and wellbeing in adolescents, and how these effects might be mediated. Methods: We did secondary analyses of publicly available data from the Our Futures study, a nationally representative, longitudinal study of 12 866 young people from age 13 years to 16 years in England. The exposure considered was the frequency of social media use (from weekly or less to very frequent [multiple times daily]) at wave 1 (participants aged 13-14 years) through wave 3 of the study (participants aged 15-16 years). Outcomes were mental health at wave 2 (with high 12-item General Health Questionnaire [GHQ12] scores [≥3] indicating psychological distress), and wellbeing at wave 3 (life satisfaction, feeling life is worthwhile, happiness, and anxiety, rated from 1 to 10 by participants). Analyses were adjusted for a minimal sufficient confounding structure, and were done separately for boys and girls. Cyberbullying, sleep adequacy, and physical activity were assessed as potential mediators of the effects. Findings: Very frequent use of social media increased from wave 1 to wave 3: from 34·4% (95% CI 32·4-36·4) to 61·9% (60·3-63·6) in boys, and 51·4% (49·5-53·3) to 75·4% (73·8-76·9) in girls. Very frequent social media use in wave 1 predicted a high GHQ12 score at wave 2 among girls (adjusted odds ratio [OR] 1·31 [95% CI 1·06-1·63], p=0·014; N=4429) and boys (1·67 [1·24-2·26], p=0·0009; N=4379). Persistent very frequent social media use across waves 1 and 2 predicted lower wellbeing among girls only (adjusted ORs 0·86 [0·74-0·99], N=3753, p=0·039 for life satisfaction; 0·80 [0·70-0·92], N=3831, p=0·0013 for happiness; 1·28 [1·11-1·48], N=3745, p=0·0007 for anxiety). Adjustment for cyberbullying, sleep, and physical activity attenuated the associations of social media use with GHQ12 high score (proportion mediated 58·2%), life satisfaction (80·1%), happiness (47·7%), and anxiety (32·4%) in girls, such that these associations (except for anxiety) were no longer significant; however, the association with GHQ12 high score among boys remained significant, being mediated only 12·1% by these factors. Interpretation: Mental health harms related to very frequent social media use in girls might be due to a combination of exposure to cyberbullying or displacement of sleep or physical activity, whereas other mechanisms appear to be operative in boys. Interventions to promote mental health should include efforts to prevent or increase resilience to cyberbullying and ensure adequate sleep and physical activity in young people. Funding: None.

The Lancet. Child & adolescent health · 131 citationsread the source →

Pediatric Circumcision in the 21st Century National Health Service: A Snapshot of Practice in a United Kingdom Center.

Introduction  Pediatric circumcision is a commonly performed operation, yet outcomes related to procedures performed for medical indications remain underreported. Aim  The aim of this study was to report outcomes of therapeutic circumcision from our center. Methods  Prospective registry of elective circumcisions was maintained and analyzed at a single institution in the United Kingdom. Data collected included information on complications (early and late), emergency presentations, and referrals back from primary care services. Results  Between August 2015 and June 2019, 300 patients (mean age: 9 years; range: 3-16 years) underwent therapeutic circumcision. The average length of follow-up data available was 2.1 years (range: 6 months to 4 years). The overall complication rate was 4.7% ( n  = 16). There were no unplanned admissions and no cases returned to the operating room as emergency. Only 1% ( n  = 3) of patients presented with an early complication (minor bleeding, pain, urinary retention), and 3.7% ( n  = 11) suffered a late complication (meatal stenosis [2.7%]). All cases of meatal stenosis had lichen sclerosus confirmed on histology. Cosmetic satisfaction was 99%. Conclusion  Therapeutic circumcision is an effective procedure in the pediatric population, which carries a low risk of early and late complications. Our study found that meatal stenosis only occurred in those patients with confirmed lichen sclerosus histology.

Surgery journal (New York, N.Y.) · 3 citationsread the source →

Depression symptoms during pregnancy and postpartum in patients with recurrent pregnancy loss and infertility: The Japan environment and children's study.

There are a limited number of studies in which the depression status was followed up throughout pregnancy and postpartum to 1 year after delivery though 8.6-33% of women with recurrent pregnancy loss (RPL) and 10-25% of women who undergo in vitro fertilization and embryo transfer (IVF-ET) suffer from depression. We examined whether RPL and IVF-ET affect depressive symptoms during pregnancy and postpartum. A nationwide large-scale birth cohort study known as the "Japan Environment and Children's Study (JECS)" was conducted. The subjects consisted of 99,202 pregnant women recruited between January 2011 and March 2014. The Kessler Psychological Distress Scale was used for the 1st trimester, 2nd/3rd trimester and 1 year postpartum. The Edinburgh Postnatal Depression Scale was used for the first and the sixth month postpartum. The screening instruments were used to quantify depressive symptoms. Women with no live births had a significantly higher prevalence of elevated depressive symptoms throughout pregnancy and postpartum. The prevalence of elevated depressive symptoms was significantly higher in the second/third trimester among women with three or more pregnancy losses with no live births. IVF-ET was associated with reduced risk of developing depressive symptoms during all pregnancies and at 1 and 6 months after delivery in women with no live births. RPL and IVF-ET did not affect postpartum depressive symptoms, and IVF-ET rather reduced the risk of depression throughout pregnancy and postpartum. Psychological support for RPL women would be necessary.

Journal of reproductive immunology · 9 citationsread the source →

The family environment as a moderator of psychosocial outcomes following traumatic brain injury in young children.

Objective: This study sought to determine whether the family environment moderates psychosocial outcomes after traumatic brain injury (TBI) in young children. Method: Participants were recruited prospectively from consecutive hospital admissions of 3- to 6-year-old children, and included 19 with severe TBI, 56 with complicated mild/moderate TBI, and 99 with orthopedic injuries (OI). They completed 4 assessments across the first 18 months postinjury. The initial assessment included measures of parenting style, family functioning, and the quality of the home. Children's behavioral adjustment, adaptive functioning, and social competence were assessed at each occasion. Mixed model analyses examined the relationship of the family environment to psychosocial outcomes across time. Results: The OI and TBI groups differed significantly in social competence, but the family environment did not moderate the group difference, which was of medium magnitude. In contrast, group differences in behavioral adjustment became more pronounced across time at high levels of authoritarian and permissive parenting; among children with severe TBI, however, even those with low levels of permissive parenting showed increases in behavioral problems. For adaptive functioning, better home environments provided some protection following TBI, but not over time for the severe TBI group. These 3-way interactions of group, family environment, and time postinjury were all of medium magnitude. Conclusion: The findings indicate that the family environment moderates the psychosocial outcomes of TBI in young children, but the moderating influence may wane with time among children with severe TBI.

Neuropsychology · 176 citationsread the source →

Informal caregiver burden among survivors of prolonged mechanical ventilation.

Rationale: Although caregiver burden is well described in chronic illness, few studies have examined burden among caregivers of survivors of critical illness. In existing studies, it is unclear whether the observed burden is a consequence of critical illness or of preexisting patient illness. Objectives: To describe 1-yr longitudinal outcomes for caregivers of patients who survived critical illness, and to compare depression risk between caregivers of patients with and without pre-intensive care unit (ICU) functional dependency. Methods: Prospective, parallel, cohort study of survivors of prolonged (greater than 48 h) mechanical ventilation and their informal caregivers. Caregivers were divided into two cohorts on the basis of whether patients were functionally independent (n = 99, 59%), or dependent (n = 70, 41%) before admission. Functional dependency was defined as dependency in one or more activities of daily living or in three or more instrumental activities of daily living. Patient and caregiver outcomes were measured 2, 6, and 12 mo after mechanical ventilation initiation. Measurements and main results: We studied three caregiver outcomes: depression risk, lifestyle disruption, and employment reduction. Most patients were male (59.8%), with a mean (SD) age of 56.6 (19.0) yr. Caregivers were mostly female (75.7%), with a mean (SD) age of 54.6 (14.7) yr. Prevalence of caregiver depression risk was high at all time points (33.9, 30.8, and 22.8%; p = 0.83) and did not vary by patient pre-ICU functional status. Lifestyle disruption and employment reduction were also common and persistent. Conclusions: Depression symptoms, lifestyle disruption, and employment reduction were common among informal caregivers of critical illness survivors. Depression risk was high regardless of patient pre-ICU functional status.

American journal of respiratory and critical care medicine · 116 citationsread the source →

Opening communication channels with people living with HIV using mobile phone text messaging: insights from the CAMPS trial.

Background: Using two-way mobile phone text messages to improve adherence to antiretroviral medication enhances communication between patients and health workers. We describe the implications of participants' responses to text messages in the Cameroon Mobile Phone SMS (CAMPS) trial. Findings: This is a cross-sectional analysis of data from the intervention arm of the CAMPS trial. CAMPS was a randomized controlled trial of motivational text messaging versus usual care to improve adherence to antiretroviral medication among people living with HIV in Yaounde, Cameroon (n = 200) over a 6 month period. Participants in the intervention arm (n = 101) were given a contact phone number, but were not required to respond to their reminder messages. If they did, their responses were noted and reported as counts and percentages. We received 99 phone calls and 55 text messages (154 responses) from 48 participants during the study period. The median number of responses was 1 (first quartile [Q1]: 1; third quartile [Q3]: 3). Half (n = 79, 51.1%) of them were expressions of gratitude. The rest included requests for logistical (n = 21, 13.6%), medical (n = 20, 12.9%) and financial (n = 11, 7.1%) support. Conclusion: Initiating two-way mobile communication opens more channels for people living with HIV to express unmet needs. Researchers, policy makers and clinicians should be ready to respond to the needs expressed by patients who respond to text messages. Trial registration: Pan-African Clinical Trials Registry: PACTR201011000261458;

BMC research notes · 19 citationsread the source →

Childhood behavior problems and health at midlife: 35-year follow-up of a Scottish birth cohort.

Background: Childhood behavior problems are associated with premature mortality. To identify plausible pathways that may account for this association, we explored the extent to which childhood behavior problems relate to health behaviors and health outcomes at midlife. Methods: The Aberdeen Children of the 1950s (ACONF) study comprises 12,500 children from the Aberdeen area, Scotland, UK. Childhood behavior problems were assessed by teacher ratings at children's age of 6-12 years. Between 2001 and 2003, surviving study members, then aged 46-51 years, were mailed a questionnaire containing enquiries about physician-diagnosed conditions (long-term disease, diabetes, high blood pressure), general health, well-being, weight, smoking, and alcohol intake. A total of 7,183 responded. Results: Two dimensions of externalizing (conduct problems and hyperactivity) and one of internalizing (emotional problems) behaviors were associated with adult health. Childhood conduct problems were related to an increased risk of long-term disease (odds ratio per one standard deviation increase; 95% confidence interval: 1.15; 1.02-1.29 for men; 1.26; 1.08-1.47 for women), obesity (1.16; 1.01-1.33 in men; 1.38; 1.14-1.68 in women), cigarette smoking (1.20; 1.07-1.34 in men; 1.17; 1.01-1.35 in women), and lower well-being. Childhood hyperactivity was associated with earlier initiation of smoking in men and women; smoking more cigarettes in women; and binge-drinking, as well as a higher frequency of hangovers in men. Internalizing behavior was related to a reduced the risk of ever smoking (.87; .80-.95 in men; .92; .85-.99 in women) and to healthier drinking patterns. In women but not men, internalizing problems also predicted a later age of smoking onset. Adjusting for socio-economic status of origin, childhood intelligence, education and age had negligible effects on these results. Conclusions: Childhood behavior problems were associated with a series of adult health-related habits that may partially account for the link between early problem behaviors and premature mortality.

Journal of child psychology and psychiatry, and allied disciplines · 47 citationsread the source →

Taking a Spiritual History Allows Clinicians to Understand Patients More Fully

Journal of Palliative MedicineVol. 3, No. 1 Innovations in End-of-Life CareTaking a Spiritual History Allows Clinicians to Understand Patients More FullyDr. Christina Puchalski and Anna L. RomerDr. Christina Puchalski and Anna L. RomerPublished Online:19 Apr 2005https://doi.org/10.1089/jpm.2000.3.129AboutSectionsPDF/EPUB ToolsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail FiguresReferencesRelatedDetailsCited byVerbalizing spiritual needs in palliative care: a qualitative interview study on verbal and non-verbal communication in two Danish hospices4 January 2022 | BMC Palliative Care, Vol. 21, No. 1Implementation of an Educational Toolkit to Increase Nurse Competence in Spirituality and Spiritual Care of Oncology Patients8 November 2022 | Journal of Holistic Nursing, Vol. 5Posicionamento sobre a Saúde Cardiovascular nas Mulheres – 2022Arquivos Brasileiros de Cardiologia, Vol. 119, No. 5Experiences of German health care professionals with spiritual history taking in primary care: a mixed-methods process evaluation of the HoPES3 intervention15 October 2022 | Family Practice, Vol. 29Religious and spiritual journeys of LGBT older adults in rural Southern Appalachia25 October 2021 | Journal of Religion, Spirituality & Aging, Vol. 34, No. 4The CASH assessment tool: A window into existential suffering19 May 2021 | Journal of Health Care Chaplaincy, Vol. 28, No. 4Integrating religion/spirituality into professional social work practice27 July 2022 | Journal of Religion & Spirituality in Social Work: Social Thought, Vol. 41, No. 4The Concept of Spirituality in the Health Sector: Contributions from the Study of Religion27 September 2022 | International Journal of Latin American Religions, Vol. 12Systematic review: The relationship between religion, spirituality and mental health in adolescents who identify as transgender13 September 2022 | Journal of Gay & Lesbian Mental Health, Vol. 26„Des Lebens Ruf an uns wird niemals enden“ – Sinnzentrierte Interventionen im Überblick30 August 2022 | Zeitschrift für Palliativmedizin, Vol. 23, No. 05Case discussion: The critically ill older adult in spiritual distressGeriatric Nursing, Vol. 47Australian Patient Preferences for the Introduction of Spirituality into their Healthcare Journey: A Mixed Methods Study3 August 2022 | Journal of Religion and Health, Vol. 27Religion, Spirituality, and Ethics in Psychiatric Practice30 March 2022 | Journal of Nervous & Mental Disease, Vol. 210, No. 8Spiritual distress in dialysis: A case report21 July 2022 | Progress in Palliative Care, Vol. 211Interprofessional communication training to address spiritual aspects of cancer care19 July 2022 | Journal of Health Care Chaplaincy, Vol. 29Spirituality in Serious Illness and HealthJAMA, Vol. 328, No. 2What is the role of spiritual care specialists in teaching generalist spiritual care? The perspectives of pastoral care staff in a large Catholic health and aged care organisation.5 July 2022 | Journal of Health Care Chaplaincy, Vol. 63Teaching spirituality to medical students: a systematic review17 June 2021 | Journal of Health Care Chaplaincy, Vol. 28, No. 3Biblical narratives and the planned change process in social work: assessment tool integration of faith and learning5 May 2022 | Journal of Religion & Spirituality in Social Work: Social Thought, Vol. 41, No. 3God, spirituality and religion in women dying from gynecological cancer19 July 2021 | Climacteric, Vol. 25, No. 3Palliative Professionals’ Views on the Importance of Religion, Belief, and Spiritual Identities toward the End of Life16 May 2022 | International Journal of Environmental Research and Public Health, Vol. 19, No. 10“Spirituality is everybody’s business”: an exploration of the impact of spiritual care training upon the perceptions and practice of rehabilitation professionals25 September 2020 | Disability and Rehabilitation, Vol. 44, No. 8A quality improvement project to standardize chaplain documentation in the electronic medical record28 December 2020 | Journal of Health Care Chaplaincy, Vol. 28, No. 2Corrigendum: Spirituality/Religiosity as a Therapeutic Resource in Clinical Practice: Conception of Undergraduate Medical Students of the Paulista School of Medicine (Escola Paulista de Medicina) - Federal University of São Paulo (Universidade Federal de São Paulo)29 March 2022 | Frontiers in Psychology, Vol. 13AD-LAST! An interdisciplinary clinical workshop to improve cultural and spiritual awareness in advance care planning skills15 March 2022 | Palliative and Supportive Care, Vol. 55Hope pictured in drawings by patients newly diagnosed with advanced cancer11 March 2022 | Journal of Clinical Nursing, Vol. 298Addressing spiritual distress in pediatric oncology14 January 2022 | Pediatric Blood & Cancer, Vol. 69, No. 3Exploring the Meaning of Spirituality and Spiritual Care with Help From Viktor Frankl24 June 2021 | Journal of Holistic Nursing, Vol. 40, No. 1Standardized Spiritual Screening Increases Chaplain Referrals Through the EMR: A Nurse-Chaplain Collaboration for Holistic Acute Healthcare23 February 2022 | Journal of Holistic Nursing, Vol. 63Interplay between spirituality and religiosity on the physical and mental well-being of cancer survivors15 September 2021 | Supportive Care in Cancer, Vol. 30, No. 2Top Ten Tips Palliative Care Clinicians Should Know About Spirituality in Serious Illness Allison Kestenbaum, George Fitchett, Paul Galchutt, Dirk Labuschagne, Shelley E. Varner-Perez, Alexia M. Torke, and Arif H. Kamal3 February 2022 | Journal of Palliative Medicine, Vol. 25, No. 2Moving Beyond Spiritual Assessments: A Dynamic, Augustinian Approach to Spiritual Care of the Dying24 January 2022 | Journal of Pastoral Theology, Vol. 29Integrating Spiritual Care in the Frame1 January 2022Evaluation of a Spiritual History with Elderly Multi-Morbid Patients in General Practice—A Mixed-Methods Study within the Project HoPES34 January 2022 | International Journal of Environmental Research and Public Health, Vol. 19, No. 1Invited Commentary: Religious Service Attendance and Implications for Clinical Care, Community Participation, and Public Health11 May 2021 | American Journal of Epidemiology, Vol. 191, No. 1Use of the Classic Hallucinogen Psilocybin for Treatment of Existential Distress Associated with Cancer1 January 2022Religiousness and Spirituality in Coping with Cancer1 January 2022Spirituality/Religiosity as a Therapeutic Resource in Clinical Practice: Conception of Undergraduate Medical Students of the Paulista School of Medicine (Escola Paulista de Medicina) - Federal University of São Paulo (Universidade Federal de São Paulo)24 December 2021 | Frontiers in Psychology, Vol. 12Patient desire for spiritual assessment is unmet in urban and rural primary care settings31 March 2021 | BMC Health Services Research, Vol. 21, No. 1Australian perspectives on spiritual care training in healthcare: A Delphi study13 July 2021 | Palliative and Supportive Care, Vol. 19, No. 6Defining Spirituality in Healthcare: A Systematic Review and Conceptual Framework18 November 2021 | Frontiers in Psychology, Vol. 12Assessing the Impact of Provider Training and Perceived Barriers on the Provision of Spiritual Care: a Mixed Methods Study12 November 2021 | Journal of Cancer Education, Vol. 5Development of an Instrument to Assess Spirituality: Reliability and Validation of the Attitudes Related to Spirituality Scale (ARES)4 November 2021 | Frontiers in Psychology, Vol. 12Association between Spirituality, Religiosity, Spiritual Pain, Symptom Distress, and Quality of Life among Latin American Patients with Advanced Cancer: A Multicenter Study Marvin O. Delgado-Guay, Alejandra Palma, Eva Duarte, Mónica Grez, Laura Tupper, Diane D. Liu, and Eduardo Bruera27 October 2021 | Journal of Palliative Medicine, Vol. 24, No. 11Spirituality and Vicarious Trauma Among Trauma Clinicians: A Qualitative Study19 October 2021 | Journal of Trauma Nursing, Vol. 28, No. 6Abordando o Sofrimento Existencial na Pessoa com Cancro20 February 2022 | Revista Portuguesa de Psiquiatria e Saúde MentalQuestioning Capacity in an Elderly Jamaican Man with Terminal Cancer Exhibiting Near-Death Awareness: A Case Report and Review of Literature Cynthia X. Pan, Kelly Thomson, Bruno A. Costa, and Jane Morris13 August 2021 | Journal of Palliative Medicine, Vol. 24, No. 9Posicionamento sobre Hipertensão Arterial e Espiritualidade – 20211 September 2021 | Arquivos Brasileiros de Cardiologia, Vol. 117, No. 3The Content, Teaching Methods and Effectiveness of Spiritual Care Training for Healthcare Professionals: A Mixed-Methods Systematic ReviewJournal of Pain and Symptom Management, Vol. 62, No. 3Religiosity and spirituality in psychiatry residency programs: why, what, and how to teach?1 August 2021 | Brazilian Journal of Psychiatry, Vol. 43, No. 4Editorial: children’s life, religiosity and spirituality matter: perspectives of special groups and their related adults16 July 2021 | International Journal of Children's Spirituality, Vol. 26, No. 3Development and protocol for a nurse-led telephonic palliative care programNursing Outlook, Vol. 69, No. 4Psychological Distress Among a Tunisian Community Sample During the COVID-19 Pandemic: Correlations with Religious Coping27 March 2021 | Journal of Religion and Health, Vol. 60, No. 3Optimism and social support as contributing factors to spirituality in Cancer patients3 January 2021 | Supportive Care in Cancer, Vol. 29, No. 6A mixed‐methods approach to comparing perceptions of cancer patients' and cancer care providers' religious and spiritual beliefs, behaviours, and attitudes23 December 2020 | European Journal of Cancer Care, Vol. 30, No. 3Spirituality and religion in residents and inter-relationships with clinical practice and residency training: a scoping review28 May 2021 | BMJ Open, Vol. 11, No. 5Using Simulation to Prepare Students for Medical Mission TripsJournal of Christian Nursing, Vol. 38, No. 2Implementation of a Meaning-Centered Psychotherapy training (MCPT) program for oncology clinicians: a qualitative analysis of facilitators and barriers9 October 2019 | Translational Behavioral Medicine, Vol. 11, No. 1Medical student reflections: Chaplain shadowing as a model for compassionate care training27 September 2020 | Medical Teacher, Vol. 43, No. 1Competence 3: Spiritual Care, Assessment and Planning19 May 2021Psychospirituelle Ressourcen in einer VUCA-Welt: Implikationen für Beratung und Coaching26 May 2021Application and Implementation of the Spiritual Needs Questionnaire in Spiritual Care Processes29 May 2021Spiritual Care in Health Care: Guideline, Models, Spiritual Assessment and the Use of the ©FICA Spiritual History Tool29 May 2021Relevance of Addressing Spiritual Needs for Clinical Support in Palliative Medicine29 May 2021Addressing Spiritual Needs in Faith Community Nursing29 May 2021Sentidos de vida e morte: reflexões de pacientes em cuidados paliativos1 January 2021 | Psicologia USP, Vol. 32Spiritual Care Competencies for Advanced Practice Nurses16 October 2021Introduction to Spirituality16 October 2021Global APN Case Study in Spirituality-Stories of Hope from Australia16 October 2021Four aspects of spiritual care: a phenomenological action research study on practicing and improving spiritual care at two Danish hospices22 October 2021 | Palliative Care and Social Practice, Vol. 15A Holistic Approach to Meeting Physical, Social and Psychological Needs23 December 2020Effectiveness of spiritual care training for rehabilitation professionals: An exploratory controlled trialNeuroRehabilitation, Vol. 47, No. 4Spiritual Well-Being in People Living with Persistent Non-Cancer and Cancer-Related Pain9 December 2020 | Pain Medicine, Vol. 196Testing of a (Spiritual) Self-Assessment Tool ((S)SAT) in a Community Hospital Setting23 November 2020 | Journal of Pastoral Care & Counseling: Advancing theory and professional practice through scholarly and reflective publications, Vol. 74, No. 4Genetic counseling graduate training to address religion and spirituality in clinical practice: A qualitative exploration of programs in North America30 May 2020 | Journal of Genetic Counseling, Vol. 29, No. 6The relationship between caregivers’ perceptions of end-of-life care in long-term care and a good resident death15 May 2020 | Palliative and Supportive Care, Vol. 18, No. 6“Give them the door but don’t push them through it”: Family Attitudes Toward Physician-Led Spiritual Care in Pediatric Palliative Medicine12 February 2020 | Journal of Religion and Health, Vol. 59, No. 6Exploring spirituality with older people: (1) rich experiences11 August 2019 | Journal of Religion, Spirituality & Aging, Vol. 32, No. 4Cultural Competency9 September 2020The Urgency of Spiritual Care: COVID-19 and the Critical Need for Whole-Person PalliationJournal of Pain and Symptom Management, Vol. 60, No. 3Spirituality in Recovery From Substance Use DisordersJournal of Psychosocial Nursing and Mental Health Services, Vol. 58, No. 9A Narrative Approach to Spirituality and Spiritual Care in Health Care3 October 2019 | Journal of Religion and Health, Vol. 59, No. 3Neural underpinning of a personal relationship with God and sense of control: A lesion-mapping study25 April 2020 | Cognitive, Affective, & Behavioral Neuroscience, Vol. 20, No. 3Patterns of Religiosity, Death Anxiety, and Hope in a Population of Community-Dwelling Palliative Care Patients in New Zealand—What Gives Hope If Religion Can’t?9 December 2019 | American Journal of Hospice and Palliative Medicine®, Vol. 37, No. 5Pain Management in Patients with Serious IllnessMedical Clinics of North America, Vol. 104, No. 3Varieties of Religious (Non)AffiliationJournal of Nervous & Mental Disease, Vol. 208, No. 5Cuidados paliativos31 August 2020 | PAJAR - Pan American Journal of Aging Research, Vol. 8, No. 1The Invisibility of Spiritual Nursing Care in Clinical Practice28 November 2019 | Journal of Holistic Nursing, Vol. 38, No. 1Spirituality in heart failure: a review of the literature from 2014 to 2019 to identify spiritual care needs and spiritual interventionsCurrent Opinion in Supportive & Palliative Care, Vol. 14, No. 1Plädoyer für einen (berufs-) alltagstauglichen Begriff von Spiritualität9 July 2021 | Spiritual Care, Vol. 0, No. 0Spirituality and mental health17 February 2020 | Journal for the Study of Spirituality, Vol. 10, No. 1Positive Interventions in Substance Use Disorders25 January 2020Spirituality/religion and painA Mother’s Love – Support Despite Disagreeing with Goals of Care10 June 2020Charting Spiritual Care: Psychiatric and Psychotherapeutic Aspects11 August 2020Spirituality5 September 2020CE: Assessing and Managing Spiritual Distress in Cancer SurvivorshipAJN, American Journal of Nursing, Vol. 120, No. 1Health Care Professionals' Reflections on Their Learning as Spiritual Generalists and Integration Into Practice28 October 2020 | Journal of Continuing Education in the Health Professions, Vol. 40, No. 4End-of-Life, Grief, and Bereavement: Strategies to Provide Comfort?3 October 2020Our transformational leader might be replaced, we are extremely stressed out!Management Research Review, Vol. 43, No. 5Navigating the Murky Waters of Hope, Fear, and Spiritual SufferingSurgical Clinics of North America, Vol. 99, No. 5Spirituality and Religion-Relevance and Assessment in the Clinical SettingCurrent Psychiatry Research and Reviews, Vol. 15, No. 2Religion, Belief, and Spirituality in Health Care2 August 2019Faith-Health Collaboration to Improve Community and Population Health12 August 2019 | NAM PerspectivesBrazilian Physicians’ Beliefs and Attitudes Toward Patients’ Spirituality: Implications for Clinical Practice29 September 2018 | Journal of Religion and Health, Vol. 58, No. 4Recent Advances in Cognitive Behavioral Therapy For Digestive Disorders and the Role of Applied Positive Psychology Across the Spectrum of GI CareJournal of Clinical Gastroenterology, Vol. 53, No. 7Preferences, use of and satisfaction with mental health services among a sample of Puerto Rican cancer patients18 July 2019 | PLOS ONE, Vol. 14, No. 7Spirituality as agency and restoration in existential recovery11 April 2018 | Journal of Spirituality in Mental Health, Vol. 21, No. 3Meaning-Centered Interventions for Patients With Advanced or Terminal Cancer18 July 2018 | Cancer Nursing, Vol. 42, No. 4Spiritual and Religious Coping of Medical Decision Makers for Hospitalized Older Adult Patients Saneta M. Maiko, Steven Ivy, Beth Newton Watson, Kianna Montz, and Alexia M. Torke27 March 2019 | Journal of Palliative Medicine, Vol. 22, No. 4Time to follow the evidence – Spiritual care in health careEthics, Medicine and Public Health, Vol. 9How and When Is Role Modeling Effective? The Influence of Mentee Professional Identity on Mentoring Dynamics and Personal Learning Outcomes18 April 2019 | Group & Organization Management, Vol. 44, No. 2Teenagers and Cannabis Use: Why It's a Problem and What Can Be Done About ItJournal of Psychosocial Nursing and Mental Health Services, Vol. 57, No. 3Haken und Ösen: Spiritualität in der klinischen PalliativversorgungWege zum Menschen, Vol. 71, No. 2Approaching Spirituality Using the Patient-Centered Clinical Method27 January 2018 | Journal of Religion and Health, Vol. 58, No. 1Medical Students’ (Dis)comfort with Assessing Religious and Spiritual Needs in a Standardized Patient Encounter10 October 2018 | Journal of Religion and Health, Vol. 58, No. 1Spirituality and Religiosity of Pharmacy Students1 February 2019 | American Journal of Pharmaceutical Education, Vol. 83, No. 1Interprofessional spiritual care in oncology: a literature review16 February 2019 | ESMO Open, Vol. 4, No. 1Physical, Psychological/Psychiatric, Social, and Spiritual Problems and Symptoms13 April 2019Spiritual Assessment in Healthcare: An Overview of Comprehensive, Sensitive Approaches to Spiritual Assessment for Use Within the Interdisciplinary Healthcare Team18 May 2019The Role of the Nurse in Providing Spiritual Care: A Case Study Approach to Exploring Specific Care Provision by Healthcare Workers in the Context of an Interdisciplinary Healthcare Team18 May 2019Teaching and Learning About Spirituality in Healthcare Practice Settings18 May 2019Religion and Spirituality Among Medical Students5 June 2019Spiritual Care: The Role of Health Care Chaplaincy4 September 2019End-of-life milieu of critically sick children admitted to a pediatric hospital: A comparative study of survivors versus nonsurvivorsIndian Journal of Palliative Care, Vol. 25, No. 4Incorporating and Teaching Spirituality into Medical Education: An Overview of the Field and Possible Educational Strategies4 September 2019Religion, Spirituality, and Stress6 March 2019Toward Comprehensive Medicine: Listening to Spiritual and Religious Needs of Patients26 April 2019 | Gerontology and Geriatric Medicine, Vol. 5Din ve Psikoloji Arasındaki Uçurum Gerçekten Ne Kadar Derin? Psikoterapilerdeki Dini İzler15 December 2018 | Cumhuriyet İlahiyat Dergisi, Vol. 22, No. 3Women's Perceptions of Using Short Films to Integrate Spirituality in TherapyJournal of Systemic Therapies, Vol. 37, No. 4Content Validation of Advanced Illness Criteria of a Palliative Care Screening Tool Lauren C. DiLello, Karen Mulvihill, Jennifer Delli Carpini, Riddhi Shah, Julia Hermanowski, and Damanjeet Chaubey29 October 2018 | Journal of Palliative Medicine, Vol. 21, No. 11Understanding, assessing, and in the spiritual of medical and October 2018 | Theology, Vol. 11, No. and of in Living with October 2018 | Journal of & Social Services, Vol. No. for the spirituality as October 2018 | Revista de Vol. 71, No. An of an aged psychiatry March 2018 | Psychiatry, Vol. 26, No. de de vida de de Vol. 25, No. support and with in Care in the Care A Narrative June | Journal of Care Medicine, Vol. No. Care in Cancer: in the of of Clinical Oncology Educational Vol. 3, No. religion/spirituality in clinical practice: A among social and and October | Journal of Clinical Psychology, Vol. 74, No. Spirituality in Care December | Journal of Religion and Health, Vol. 57, No. of to spiritual care at the of a phenomenological exploration from the of palliative care February 2018 | Journal for the Study of Spirituality, Vol. 8, No. Existential Distress in Pediatric Cancer December and Patient Spiritual in the through October of Spirituality in November Psychological/Psychiatric, Social, and Spiritual Problems and July and End-of-Life Care in Cancer in Oncology Nursing, Vol. No. Care in Hospice and Palliative Journal of Hospice and Palliative Care, Vol. 20, No. and Spirituality: Literature review and Journal of Counseling, Vol. 18, No. of the tool existential communication between and cancer August | European Journal of General Practice, Vol. 23, No. Education and of Christian Nursing, Vol. 34, No. Care Interventions in to and Therapy C. and D. September | Journal of Palliative Medicine, Vol. 20, No. in Patients with A Qualitative September | Journal of Research in Nursing and Vol. 14, No. theory on the and in an exploratory case study September | Vol. 69, No. of the of Spirituality and Palliative Care Research and of Pain and Symptom Management, Vol. No. of a spiritual care training program for staff on November | Palliative and Supportive Care, Vol. 15, No. 4Spiritual distress and spiritual care in advanced heart July | Reviews, Vol. and Spiritual Patient Simulation in Nursing, Vol. No. Vol. 42, No. 4The impact of a spiritual in patients with and and their support December | Vol. 26, No. 3The Importance of a Spiritual History in Healthcare Vol. No. About Substance Use DisordersJournal of Psychosocial Nursing and Mental Health Services, Vol. No. and Spiritual Beliefs of April | Journal of Religion and Health, Vol. No. Care Perceptions of and With of Hospice & Palliative Nursing, Vol. 19, No. in Substance Use What to Know to Practice30 November | in Mental Health Nursing, Vol. 38, No. End-of-Life Care to Religious and Vol. No. of Social Education, Vol. 53, No. Nursing Care and of Christian Nursing, Vol. 34, No. 1The of taking a religious and spiritual July | Psychiatry, Vol. 24, No. religion and spirituality in Vol. No. the role of religious in the at the of of Vol. No. care spiritual March | Supportive Care in Cancer, Vol. 24, No. Spiritual Care and the Role of An Review of Literature and April | Journal of Religion and Health, Vol. No. of the Spiritual Needs of of with Is in the June | Journal of Palliative Medicine, Vol. 19, No. Impact of a Tool for Comprehensive Assessment of Palliative Care on Assessment at and of Pain and Symptom Management, Vol. No. from Healthcare Students to Understand Spiritual Assessment in Clinical Practice29 October | Journal of Religion and Health, Vol. No. Spirituality in January | Journal of Religion and Health, Vol. No. 3Development and of to Assess Nurse Provision of Spiritual August 2014 | Journal of Holistic Nursing, Vol. 34, No. and Validation of the Practice Assessment September 2014 | Research on Social Practice, Vol. 26, No. and the Medical A of July | Journal of Health Care Chaplaincy, Vol. 22, No. history taking in palliative care: A controlled September | Palliative Medicine, Vol. 30, No. Is Is Using A and the Life With American in Spiritual March | Journal of in Mental Health, Vol. 11, No. and spiritual in September | International Journal of and Mental Health, Vol. No. 1The of Hospital to and Patients’ Spiritual A May | Journal for the Study of Spirituality, Vol. No. 1The and to March End-of-Life Spiritual March in Holistic Patient Journal of Nursing, Vol. No. of spiritual assessment for older September 2014 | and Vol. No. und der der Care, Vol. No. Spirituality and A for Holistic January | Journal of Religion and Health, Vol. No. and Belief, in Care spiritual history tool by C. M. Puchalski as an for an interdisciplinary in January | Journal for of and Social Vol. 21, No. the of Spiritual A Pain and Palliative Care Service Quality of Pain and Symptom Management, Vol. No. of Spiritual Assessment in September | Vol. No. the of Christian Nursing, Vol. 32, No. 4Spiritual care: is the assessment tool for palliative Journal of Palliative Nursing, Vol. 21, No. und Spiritualität in der September | Vol. 60, No. of September of spirituality assessment in palliative care patients in November 2014 | Progress in Palliative Care, Vol. 23, No. 4The for Spiritual A Mixed-Methods July | Oncology Nursing Vol. 42, No. 4The Integration of Religion and Spirituality in Social Practice: A May | Social Vol. 60, No. 3The and Educational of a Spiritual Life Review for Patients with and June 2014 | Journal of Cancer Education, Vol. 30, No. in Geriatric Palliative in Geriatric Medicine, Vol. No. An for Spiritual Well-Being May | Journal of Religion & Spirituality in Social Work: Social Thought, Vol. 34, No. Spiritual Assessment March | Journal of Health Care Chaplaincy, Vol. 21, No. American on Mental Health, and Help April | and Vol. 60, No. of Christian Nursing, Vol. 32, No. the Spiritual Needs and of Oncology Patients in Nursing Practice, Vol. 29, No. Care Training to Healthcare Professionals: A Systematic April | Journal of Pastoral Care & Counseling: Advancing theory and professional practice through scholarly and reflective publications, Vol. 69, No. analysis of spiritual

Journal of Palliative Medicine · 741 citationsread the source →

Continuous low-level vagus nerve stimulation reduces stellate ganglion nerve activity and paroxysmal atrial tachyarrhythmias in ambulatory canines.

Background: We hypothesize that left-sided low-level vagus nerve stimulation (LL-VNS) can suppress sympathetic outflow and reduce atrial tachyarrhythmias in ambulatory dogs. Methods and results: We implanted a neurostimulator in 12 dogs to stimulate the left cervical vagus nerve and a radiotransmitter for continuous recording of left stellate ganglion nerve activity, vagal nerve activities, and ECGs. Group 1 dogs (N=6) underwent 1 week of continuous LL-VNS. Group 2 dogs (N=6) underwent intermittent rapid atrial pacing followed by active or sham LL-VNS on alternate weeks. Integrated stellate ganglion nerve activity was significantly reduced during LL-VNS (7.8 mV/s; 95% confidence interval [CI] 6.94 to 8.66 versus 9.4 mV/s [95% CI, 8.5 to 10.3] at baseline; P=0.033) in group 1. The reduction was most apparent at 8 am, along with a significantly reduced heart rate (P=0.008). Left-sided low-level vagus nerve stimulation did not change vagal nerve activity. The density of tyrosine hydroxylase-positive nerves in the left stellate ganglion 1 week after cessation of LL-VNS were 99 684 μm(2)/mm(2) (95% CI, 28 850 to 170 517) in LL-VNS dogs and 186 561 μm(2)/mm(2) (95% CI, 154 956 to 218 166; P=0.008) in normal dogs. In group 2, the frequencies of paroxysmal atrial fibrillation and tachycardia during active LL-VNS were 1.4/d (95% CI, 0.5 to 5.1) and 8.0/d (95% CI, 5.3 to 12.0), respectively, significantly lower than during sham stimulation (9.2/d [95% CI, 5.3 to 13.1]; P=0.001 and 22.0/d [95% CI, 19.1 to 25.5], P<0.001, respectively). Conclusions: Left-sided low-level vagus nerve stimulation suppresses stellate ganglion nerve activities and reduces the incidences of paroxysmal atrial tachyarrhythmias in ambulatory dogs. Significant neural remodeling of the left stellate ganglion is evident 1 week after cessation of continuous LL-VNS.

Circulation · 180 citationsread the source →

Does Improving Medical Record Documentation Better Reflect Severity of Illness in Neurosurgical Patients?

Physician documentation in the medical record is essential for communicating the clinical status and care plan to other healthcare providers. The medical record also serves as a medicolegal document to protect the physician should medical malpractice be alleged. In addition to these uses, documentation of patients' diagnoses and procedures is used by hospital coders to calculate severity of illness (SOI) and risk of mortality (ROM) ratings. A rating given from level 1 to 4 (4 being most severe), SOI reflects a patient's degree of physiological illness. Also scored from 1 to 4, ROM is a gauge of the patient's risk of death while in the hospital on the basis of the patient's diagnoses (Table 1).TABLE: 1. Severity of Illness and Risk of Mortality Grading SystemsBoth SOI and ROM have significant roles in healthcare economics. Hospital reimbursement depends in part on SOI. The Centers for Medicare and Medicaid Services (CMS) is the entity of the federal government that is responsible for healthcare financing, coverage, and payment of Medicare and Medicaid beneficiaries. Formerly known as the Health Care Financing Administration, CMS adopted diagnosis-related groups (DRGs) in 1983 after their development at Yale University in 1970. Their purpose was to replace the traditional per-diem method of hospital reimbursement. Per diems were cost based and characterized as an undifferentiated patient day regardless of patient illness. In contrast, each DRG classification represents similar resource consumption and length-of-stay patterns so that reimbursement is based on these expectations. In 2008, the CMS went one step further and added a severity-adjusted version to the original DRGs called Medicare-severity DRG.1 The severity adjustment takes into account the patient's SOI and is now used by the Medicare Inpatient Prospective Payment System. The SOI and ROM scores are also being used to gauge quality control issues. Data for every Medicare inpatient stay are maintained in the Medicare Provider and Analysis Review file.2 Quality improvement organizations contracted by CMS to provide quality oversight to Medicare providers use the data to assess potential problems with noncompliance. Additionally, these organizations analyze a facility's Medicare-severity DRG mix to look for problems with hospitals that may potentially always code for higher-weighted DRGs and appear as outliers compared with other similar facilities.3 Finally, “quality of care” assessments use SOI and ROM. Mortality rates vary between providers and hospitals; the presumption is that after controlling for patients' severity of illness, residual differences in mortality rates relate to differences in quality of care. Corporations such as Thompson Reuters have created a marketing tool and “status” based on this information that hospitals may strive to achieve. The well-known “Top 100 Hospitals”4 lists the 100 “best” hospitals across the country in a given specialty line. When the results of the Hospital Consumer Assessment of Healthcare Providers and Systems survey5 are compared between winners of the Top 100 Hospitals award and nonwinners, the award winners do slightly better than nonwinners on all survey items that showed modest but statistically significant differences between the 2 groups.6 These findings suggest that marketing tools such as the Top 100 Hospitals might play a role in consumer perception, assessment, and decision making. All-patient-refined DRGs (APR-DRGs) are another mode for comparison. Trademarked by 3M, APR-DRGs classify all inpatient admissions based on the SOI and ROM levels represented by International Classification of Disease, ninth revision (ICD-9), codes. Institutions such as the Agency for Healthcare Research and Quality are using APR-DRGs for quality monitoring purposes, especially for severity adjustment of mortality rates.1 The SOI and ROM are derived from documentation of patients' diagnoses and comorbidities.1,7 Errors in documentation can lead to overestimation or underestimation of expected mortality, which has an effect on an institution's comparison with other hospitals.8,9 Furthermore, neurosurgeons contribute significantly to hospitals' financial health.10,11 Better documentation of admitting diagnoses and comorbidities should enable more accurate ICD-9 coding, which in turn should lead to more accurate calculation of SOI and ROM. The rationale for the study stemmed from a need for resident participation in a quality improvement project, a requirement dictated by the Accreditation Council of Graduate Medical Education.12 Before the project, a preliminary review of progress notes on the neurosurgery service by one of the authors (N.S.L.) indicated suboptimal documentation of patient comorbidities. The objective of this study was to determine whether interventions designed to effectively improve physician clinical documentation would subsequently lead to increased capture of SOI and ROM. A secondary aim of the project was to simultaneously provide residents with a quality improvement opportunity. We hypothesize that the multimodality interventions that improve neurosurgeons' clinical documentation lead to better characterization of SOI and ROM. MATERIALS AND METHODS Documentation Improvement Interventions Before data collection, 3 specific interventions were used to educate physicians with the goal of improving medical record documentation as part of the master's thesis of one of the authors (C.H.). These modalities included the following: group in-service, development and use of a progress note template, and concurrent medical record coder review and feedback to the physician during the patients' in-hospital stays. Faculty and residents in the Division of Neurological Surgery at University of Missouri Hospitals and Clinics participated in a 30-minute in-service on coding, SOI, and ROM. A new neurosurgery progress note template (Figure 1) was introduced, and instructions for its use were provided. The template was organized to include comorbidities listed as ICD-9 codes and grouped into organ system for ease of location.FIGURE 1: Neurosurgery progress note. Mechanisms for queries to the physicians from the nurse reviewer and appropriate responses were explained to the group. Informed consent was obtained from the participating physicians. The study was approved by the Health Sciences Institutional Review Board. After the in-service, a nurse-reviewer (working in the capacity of assistant manager of medical records) began random review of neurosurgical patient records. Random record review was performed 2 to 3 times per week, averaging 10 to 15 h/wk, while patients were still hospitalized to look for potential diagnoses that were not appropriately documented. Charts for review were chosen at random; however, intensive care unit patients were given priority for review over floor patients. Information gathered was kept on a worksheet (Figure 2), and cases for which questions existed were e-mailed to the physicians with a copy to the senior author (N.S.L). A typical query follows: “Patient X, MNICU 13, had a 3400cc EBL during OR, and received several units of PRBCx and FFP. H&H dropped from 12.1/35.2 to 5.9/17. Would a secondary diagnosis of acute blood loss anemia be appropriate? If so, please document in the progress notes.”FIGURE 2: Clinical documentation review tool. Follow-up on queries was completed to determine whether the physician had documented the diagnosis in question. If no response was made, a second e-mail was sent. In cases when the patient had been discharged and confirmation or disagreement with the query was not documented in the progress notes as requested, an e-mail notification was sent, asking the physician to address the query in the discharge summary. This method of review, queries by e-mail, and rereview occurred for 8 weeks. Data Collection All neurosurgery service adult in-patient charts at University of Missouri Hospital and Clinics were retrospectively reviewed from 3 time intervals. June 2004 to December 2004 represented the preintervention period. August 2007 to December 2007 was the time period during active educational intervention. Finally, June 2008 to December 2008 represented the postintervention period. Data collected included patient age, sex, ICD-9 diagnoses, raw patient mortality, SOI, and ROM. Patients younger than 18 years of age at the time of admission were excluded. Versions 24 and 25 of the 3M APR-DRGs13,14 were used to calculate ROM and SOI. Preliminary data were pulled from each time period and analyzed according to the description below. From the results of the preliminary data analysis, the standard deviation for the SOI and ROM outcomes was estimated to be about 1.0 units. It was determined that sample sizes of 300 patients per time period would give well over 80% power for detecting differences in mean scores of 0.25 units. The estimated power was found using the POWER procedure in SAS version 9 (SAS Institute Inc, Cary, North Carolina). Data Analysis The outcomes of mortality, SOI, and ROM can all be influenced by a patient's age, sex, and primary diagnosis. Consequently, analyses were done to determine whether any of these variables differed between time periods. Furthermore, these variables were considered covariates when testing the primary outcomes for differences between time periods. Primary diagnoses were grouped into 9 categories based on ICD-9 codes as follows: malignant neoplasms, benign neoplasms, nervous system disorders, cardiovascular disease, musculoskeletal disorders, skull/spine injuries, brain contusions, complications, and other diagnoses. The Kruskal-Wallis test was used to test for differences in age between time periods. Sex differences were assessed with a χ2 model. Stratification or adjustment for differences in age and sex was performed with the Cochran-Mantel-Haenszel test. For the prediction of the probability of occurrence of mortality, logistic regression was used. Finally, the cumulative logit model was used to analyze SOI and ROM, taking into account differences in primary diagnoses over time. The SAS Analytical Software version 9.0 was used for the analysis. In view of the fact that preliminary data were reanalyzed, allowing 2 opportunities to reject the null hypothesis of no group differences, only values of P < .01 were considered significant. RESULTS Chart Review Intervention During the 8-week period of chart review, 53 inpatient charts were reviewed. A total of 99 reviews were completed in total, with 41 queries sent to physicians (41%). All but 2 queries were sent via e-mail. Sixteen second-request queries were sent. Twenty queries (53%) were agreed on and documented in the record. A physician disagreed with 1 query, so no change in documentation was made, and 17 queries yielded no response (44.7%). SOI/ROM Values Over the 3 time periods, 1009 cases were analyzed: 329 patients during the preintervention period, 306 patients during the intervention period, and 374 patients during the post-intervention period. The simple mean values of SOI in the 3 time periods were as follows: 1.72 before intervention, 1.69 during intervention, and 1.82 after intervention (P = .09, χ2). Simple mean values of ROM in each time period were 1.40, 1.43, and 1.56 respectively (P = .02, χ2), with mortality rates of 6.38%, 3.59%, and 5.61% respectively (P = .27, χ2). Raw data results are summarized in Table 2.TABLE: 2. Summary of Raw DataaEffect of Age and Sex on SOI and ROM Mean patient age differed significantly between time periods: 48.3 years of age before intervention, 52.1 years of age during intervention, and 53.1 years of age after intervention (P = .001, Kruskal-Wallis). Accounting for differences in age did not affect SOI (P = .24), ROM (P = .48), and raw mortality (P = .06, Cochran-Mantel-Haenszel). Sex distributions were similar in each time period (P = .64, χ2). Effect of Diagnosis The distribution of diagnoses in each time period is shown in Table 3. Primary diagnosis did not differ significantly between the preintervention and intervention time periods (P = .13), even when adjusted for age and sex (P = .28, Cochran-Mantel-Haenszel). However, when the preintervention and intervention periods were combined and compared with the postintervention period, differences in diagnoses were noted (P < .001, Cochran-Mantel-Haenszel).TABLE: 3. Distributions of Diagnoses Between 3 Time PeriodsIn an effort to account for differences in diagnoses, a statistical compromise had to be achieved between not using primary diagnoses as a covariant and using them with a large number of categories. Therefore, 3 categories were established on the basis of the diagnosis frequency: cardiovascular disease (32 deaths), brain contusion (6 deaths), and other (15 deaths). After diagnosis differences (3 categories) were accounted for with logistic regression, no differences in mortality rate were found between the postintervention period and either the intervention (P = .08) or preintervention (P = .15) period. No significant differences between preintervention and postinterventional periods for SOI (P = .29) or ROM (P = .48) were present when differences in diagnoses were accounted for (cumulative logit model). DISCUSSION Overall, we expected SOI to be lower during the preintervention period and the ROM modified by SOI to be lower during the intervention and postintervention periods. However, despite interventions such as educational in-service, progress note template, and reminders about the possibility of addending progress notes, no differences in SOI or ROM were present during active intervention or in the period after intervention. The lack of impact of intervention on SOI and ROM was not affected by the differences in age or diagnoses present among the 3 time periods. Other studies have shown success with progress note templates. Grogan et al15 focused on improvements to physician documentation and evaluated the effectiveness in terms of ICD-9 coding, APR-DRG, DRG weight, and University Healthcare Consortium-predicted mortality. A progress note template included a section developed by coding specialists with 40 of the most common general surgery comorbidities and complications (in check-box format). A significant increase was found in total ICD-9 codes, template-specific ICD-9 codes, APR-DRG, DRG weight, and University Healthcare Consortium-predicted mortality. Sprtel and Zlabek16 also showed success with the implementation of a progress note template in conjunction with a brief documentation lecture. Their results showed an absolute increase in the highest code by 14.5%, increased billable income by $10 385, and improved resident awareness of documentation. A number of interventions for improvement in documentation and assessment end points have been suggested. Marco and Buchman17 noted that simply asking for private commitment to change can yield measurable results. They obtained in writing acknowledgement that improvement in documentation was necessary and noticed that the acknowledging physicians showed improvement in the percentage of cases with the required documentation over time. As-Sanie et al18 had success with obstetrics/gynecology residents after providing individual instructional sessions with faculty on coding and documentation, whereas Lemen19 also showed success within the same specialty with the assistance of an online module. At the other end of the spectrum, Tinsley20 described the use of a whole multidisciplinary team to improve documentation among psychiatry residents. The team met regularly to clarify resident charting responsibilities, to make the inpatient record a better communication tool, and to consider the various causes of charting deficiencies. Improvement in charting 4 of 5 items (admission note, an off-service note, descriptions of medication changes, daily progress notes, and the name and discipline of the individual recording these items) improved significantly after 1 month of intervention and was maintained at 6 months. Table 4 summarizes these intervention results.TABLE: 4. Summary of Literature ReviewaTime is likely necessary to establish educational interventions that generate long-lasting habits in physicians and improve documentation. Relationships are present between repetition and automaticity of such habits. For instance, in 1 study,33 82 mostly postgraduate students were asked to choose a healthy eating, drinking, or exercise behavior to convert into a daily habit. A self-report habit index34 was used to quantify habit strength. During 12 weeks of active study, 48% of participants reached levels thought to be consistent with habit formation. Further analysis concluded that the time needed for participants to reach 95% of their automaticity ranged from 18 to 254 days (mean, 64 days). The 8 weeks of active intervention in this study may not have been sufficient to allow documentation habits to form fully. Furthermore, educators must also question whether the amount of time required to learn simple habits differs from more complex habits requiring additional planning. Verplanken35 showed that when repetitions are limited, a simple behavior had a higher habit score than a complex behavior. Physician documentation in the setting of demanding schedules and the intricacies of medical coding likely falls into the category of a complex habit. Therefore, physicians' documentation habits promoting better documentation may be on the longer end of the to The effect the number of daily repetitions on the time to automaticity is also This study other that may improvement in documentation. did not to of queries with documentation The physicians would not be to their e-mail in the day or and progress note were not Additionally, physicians may have that an or new note in the medical record for the purpose of to a query was given their other A more of review and physician feedback have to an increase in in the medical record. and medical for diagnoses that were and not appropriately documented is a Over the 8 weeks of the intervention period, 99 reviews on 53 charts were Therefore, of the total neurosurgical admissions during the 8-week period, only of them were reviewed at during their For review and more nurse-reviewer might be required to review a of inpatient charts before significant results can be in improving documentation be that the progress note template was progress note was from Grogan et was modified by a multidisciplinary the of neurosurgical and the assistant manager of medical to include complications and comorbidities typical of neurosurgical patients. No studies were to the of the template in accurate diagnoses. the educational interventions improved medical record documentation, SOI and ROM may not have differed between the 3 time periods for other This study did not assess the level and of the medical Medical coders are by to them on can and codes However, a is required to review and to the clinical between various and common complications with specific for the to documentation to look Documentation of comorbidities and complications on a progress note template might provide more documentation but not more accurate must also consider whether ICD-9 codes are appropriate for SOI and ROM. have found of in codes, on the diagnoses and being After a review of medical from et concluded that coding of diagnosis had an rate of compared with medical record et the of codes for cardiovascular and risk Overall, in Medicare the of codes was whereas the ranged from only to the ICD-9 data to illness, other studies have shown that these can is in disease and For instance, et and the of Health found that an illness of ICD-9 data from a in the with from and ICD-9 codes have been found in of disease to be for is not known whether the same can be for using ICD-9 codes to calculate of SOI and ROM. Interventions to improve documentation by physicians to change SOI or ROM in patients on a neurosurgical these interventions were to make a or coders a amount of and to at documentation to look to improve their quality in to SOI and ROM must be to time and to the of the of these physicians should play an active role in the development and of educational such as physician feedback and chart review all patients on the inpatient service may lead to a more medical record documentation. for this project was by the Division of Neurological Surgery Research The authors have no financial or in any of the or described in this This was based in part on the 2007 master's thesis project by for the University of Missouri Health and are Interventions for Physician Documentation of Severity of Illness and Risk of We to of University of Missouri for assistance with the statistical analysis. We also to for

Neurosurgery · 11 citationsread the source →