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Emotional impact on healthcare providers involved in medical assistance in dying (MAiD): a systematic review and qualitative meta-synthesis.

Background: Medical assistance in dying (MAiD) traverses challenging and emotionally overwhelming territories: healthcare providers (HCPs) across jurisdictions experience myriad of affective responses secondary to possible tensions between normative and interwoven values, such as sanctity of life, dignity in death and dying and duty to care. Objective: To determine the emotional impact on HCPs involved in MAiD. Methods: Inclusion restricted to English language qualitative research studies from four databases (OVID Medline, EMBASE, CINAHL and Scopus), from beginning until 30 April 2021, and grey literature up to August 2021 were searched. Key author, citation and reference searches were undertaken. We excluded studies without rigorous qualitative research methodology. Included studies were critically appraised using the Joanna Briggs Institute's critical appraisal tool. Analysis was conducted using thematic meta-synthesis. The cumulative evidence was assessed for confidence using the Confidence in the Evidence from Reviews of Qualitative Research approach. Results: The search identified 4522 papers. Data from 35 studies (393 physicians, 169 nurses, 53 social workers, 22 allied healthcare professionals) employing diverse qualitative research methodologies from five countries were coded and analysed. The thematic meta-synthesis showed three descriptive emotional themes: (1) polarised emotions including moral distress (n=153), (2) reflective emotions with MAiD as a 'sense-making process' (n=251), and (3) professional value-driven emotions (n=352). Discussion: This research attempts to answer the question, 'what it means at an emotional level', for a MAiD practitioner. Legislation allowing MAiD for terminal illness only influences the emotional impact: MAiD practitioners under this essential criterion experience more polarised emotions, whereas those practising in jurisdictions with greater emphasis on allaying intolerable suffering experience more reflective emotions. MAiD practitioner's professional values and their degree of engagement influence the emotional impact, which may help structure future support networks. English language literature restriction and absence of subgroup analyses limit the generalisability of results.

BMJ open · systematic review · 16 citationsread the source →

Working with parents to counteract bullying: A randomized controlled trial of an intervention to improve parent-school cooperation.

This study examined the effectiveness of an intervention aimed at improving parent-school cooperation in counteracting bullying. Using a randomized controlled trial, data of teachers, parents of non-victimized children, and children themselves were collected at 13 intervention and 14 control schools (grades 3-6, N at post-assessment: teachers = 83, parents = 153, children = 2,510) at two time points (time lag about 6 months). Results showed positive effects of the intervention for some aspects of the primary outcomes: parents' and teachers' attitudes and efforts, whereas no effects were found of teachers' or parents' competences in counteracting bullying. No intervention effects were found for secondary outcomes: children's self-reported bullying, victimization, well-being, and self-esteem. The findings indicate that, due to the intervention, teachers and parents were more aligned and able to cooperate, even within the short time of the intervention: one school year. This is the first essential step to systematically addressing parents' role in tackling bullying; future research is needed to examine the long-term effects of parent and school interventions in enhancing the effectiveness of anti-bullying programs.

Scandinavian journal of psychology · randomised controlled trial · 14 citationsread the source →

Clinical and cost-effectiveness of nurse-delivered sleep restriction therapy for insomnia in primary care (HABIT): a pragmatic, superiority, open-label, randomised controlled trial.

Background: Insomnia is prevalent and distressing but access to the first-line treatment, cognitive behavioural therapy (CBT), is extremely limited. We aimed to assess the clinical and cost-effectiveness of sleep restriction therapy, a key component of CBT, which has the potential to be widely implemented. Methods: We did a pragmatic, superiority, open-label, randomised controlled trial of sleep restriction therapy versus sleep hygiene. Adults with insomnia disorder were recruited from 35 general practices across England and randomly assigned (1:1) using a web-based randomisation programme to either four sessions of nurse-delivered sleep restriction therapy plus a sleep hygiene booklet or a sleep hygiene booklet only. There was no restriction on usual care for either group. Outcomes were assessed at 3 months, 6 months, and 12 months. The primary endpoint was self-reported insomnia severity at 6 months measured with the insomnia severity index (ISI). The primary analysis included participants according to their allocated group and who contributed at least one outcome measurement. Cost-effectiveness was evaluated from the UK National Health Service and personal social services perspective and expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. The trial was prospectively registered (ISRCTN42499563). Findings: Between Aug 29, 2018, and March 23, 2020 we randomly assigned 642 participants to sleep restriction therapy (n=321) or sleep hygiene (n=321). Mean age was 55·4 years (range 19-88), with 489 (76·2%) participants being female and 153 (23·8%) being male. 580 (90·3%) participants provided data for at least one outcome measurement. At 6 months, mean ISI score was 10·9 (SD 5·5) for sleep restriction therapy and 13·9 (5·2) for sleep hygiene (adjusted mean difference -3·05, 95% CI -3·83 to -2·28; p<0·0001; Cohen's d -0·74), indicating that participants in the sleep restriction therapy group reported lower insomnia severity than the sleep hygiene group. The incremental cost per QALY gained was £2076, giving a 95·3% probability that treatment was cost-effective at a cost-effectiveness threshold of £20 000. Eight participants in each group had serious adverse events, none of which were judged to be related to intervention. Interpretation: Brief nurse-delivered sleep restriction therapy in primary care reduces insomnia symptoms, is likely to be cost-effective, and has the potential to be widely implemented as a first-line treatment for insomnia disorder. Funding: The National Institute for Health and Care Research Health Technology Assessment Programme.

Lancet (London, England) · randomised controlled trial · 59 citationsread the source →

Impact of neighborhood resources on cardiovascular disease: a nationwide six-year follow-up.

Background: Living in a socially deprived neighborhood is associated with lifestyle risk factors, e.g., smoking, physical inactivity and unhealthy diet, as well as an increased risk of cardiovascular disease, i.e., coronary heart disease and stroke. The aim was to study whether the odds of cardiovascular disease vary with the neighbourhood availability of potentially health-damaging and health-promoting resources. Methods: A nationwide sample of 2 040 826 men and 2 153 426 women aged 35-80 years were followed for six years for first hospitalization of coronary heart disease or stroke. Neighborhood availability of health-damaging resources (i.e., fast-food restaurants and bars/pubs) and health-promoting resources (i.e., health care facilities and physical activity facilities) were determined by use of geographic information systems (GIS). Results: We found small or modestly increased odds ratios (ORs) for both coronary heart disease and stroke, related to the availability of both health-damaging and health-promoting resources. For example, in women, the unadjusted OR (95 % confidence interval) for stroke in relation to availability of fast-food restaurants was 1.18 (1.15-1.21). Similar patterns were observed in men, with an OR = 1.08 (1.05-1.10). However, the associations became weaker or disappeared after adjustment for neighborhood-level deprivation and individual-level age and income. Conclusions: This six year follow-up study shows that neighborhood availability of potentially health-damaging as well as health-promoting resources may make a small contribution to the risk of coronary heart disease and stroke. However, most of these associations were attenuated or disappeared after adjustment for neighborhood-level deprivation and individual-level age and income. Future studies are needed to further examine factors in the causal pathway between neighborhood deprivation and cardiovascular disease.

BMC public health · 26 citationsread the source →

Cost-effectiveness of Enhanced Recovery Versus Conventional Perioperative Management for Colorectal Surgery.

Objective: To determine the cost-effectiveness of enhanced recovery pathways (ERPs) versus conventional care for patients undergoing elective colorectal surgery. Background: ERPs for colorectal surgery are clinically effective, but their cost-effectiveness is unknown. Methods: A multi-institutional prospective cohort cost-effectiveness analysis was performed. Adult patients undergoing elective colorectal resection at 2 university-affiliated institutions from October 2012 to October 2013 were enrolled. One center used an ERP, whereas the other did not. Postoperative outcomes were recorded up to 60 days. Total costs were reported in 2013 Canadian dollars. Effectiveness was measured using the SF-6D, a health utility measure validated for postoperative recovery. Uncertainty was expressed using bootstrapped estimates (10,000 repetitions). Results: A total of 180 patients were included (conventional care: n = 95; ERP: n = 95). There were no differences in patient characteristics except for a higher proportion of laparoscopy in the ERP group. Mean length of stay was shorter in the ERP group (6.5 vs 9.8 days; P = 0.017), but there were no differences in complications or readmissions. Patients in the ERP group returned to work quicker and had less caregiver burden. There was no difference in quality of life between the 2 groups. The cost of the ERP program was $153 per patient. Overall societal costs were lower in the ERP group (mean difference = -2985; 95% confidence interval, -5753 to -373). The ERP had a greater than 99% probability of cost-effectiveness. The results were insensitive to a range of assumptions and subgroups. Conclusions: Enhanced recovery is cost-effective compared with conventional perioperative management for elective colorectal resection.

Annals of surgery · clinical trial · 116 citationsread the source →

Catastrophic health expenditure, social protection coverage, and financial coping strategies in adults with symptoms of chronic respiratory diseases in Kenya: a cross-sectional study.

Background: Despite the socioeconomic consequences of an increasing burden of chronic respiratory diseases, there is little evidence on the incidence and determinants of catastrophic health expenditure (CHE) in people with chronic respiratory disease symptoms in Kenya. We aimed to generate this evidence by collecting data on medical and non-medical costs, lost income, social protection coverage, and financial coping strategies for such people in Kenya. Methods: We conducted a cross-sectional survey of consecutively recruited adults seeking care for chronic respiratory disease symptoms at five public health-care facilities in Meru County, Kenya, between Sept 5, 2019, and Oct 1, 2020. Patient costs, National Health Insurance Fund (NHIF) coverage, financial coping strategies, and sociodemographic and clinical data were collected from surveys and medical records. The main study outcomes were the incidence of, and social and health factors associated with, CHE in this cohort. CHE incidence was calculated through the WHO threshold of direct out-of-pocket costs being greater than 10% of a household's monthly total expenditure. Multivariable logistic regression analyses generated adjusted odds ratios (aORs) with 95% CIs of health and social factors associated with CHE, including age, sex, education level, tobacco use, income, being accompanied, poverty level (with the first quintile being the richest to the fifth quintile being the poorest), NHIF usage, coping strategies, final diagnosis, and health system level at which they were seeking care. Findings: Of 319 eligible people invited, 296 (93%) consented to participate and completed surveys. Mean total cost was 1062 Kenyan shillings (KES; 95% CI 896-1228; US$9·1), of which 40·0% was due to direct non-medical costs (KES 425, 95% CI 361-489; $3·7), 36·7% to direct out-of-pocket medical costs (KES 390, 324-456; $3·1), and 23·3% to lost income (KES 247, 153-341, $2·1). 212 (72%) of 296 participants did not have NHIF, 282 (95%) of 296 used coping strategies during care-seeking, and 59 (20%) of 296 were accompanied by a carer during health-care seeking. 76 (26%) of 296 participants had CHE. CHE was associated with being aged 30-44 years old (aOR 2·6, 95% CI 1·3-5·3, p=0·010), being female (1·8, 1·3-2·7, p=0·0021), having higher than secondary school education (1·6, 1·1-2·3, p=0·0083), being accompanied during health-care-seeking visits (3·2, 1·7-5·9, p<0·0001), belonging to the second poverty quintile (2·0, 1·9-2·1, p<0·0001), and seeking care from subcounty hospitals (9·7, 9·6-9·8, p<0·0001) and county hospitals (25·1, 15·7-40·2, p<0·0001). Interpretation: These findings suggest a sizeable burden of CHE in people seeking care for chronic respiratory disease symptoms in Meru County in Kenya, driven by socioeconomic and sex inequalities and impaired access to health care and social protection. Funding: UK-Aid, UK National Institute for Health and Care Research, and UK Research and Innovation.

The Lancet. Global health · 3 citationsread the source →

Repetitive task training for improving functional ability after stroke.

Background: Repetitive task training (RTT) involves the active practice of task-specific motor activities and is a component of current therapy approaches in stroke rehabilitation. Objectives: Primary objective: To determine if RTT improves upper limb function/reach and lower limb function/balance in adults after stroke. Secondary objectives: 1) To determine the effect of RTT on secondary outcome measures including activities of daily living, global motor function, quality of life/health status and adverse events. 2) To determine the factors that could influence primary and secondary outcome measures, including the effect of 'dose' of task practice; type of task (whole therapy, mixed or single task); timing of the intervention and type of intervention. Search methods: We searched the Cochrane Stroke Group Trials Register (4 March 2016); the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library 2016, Issue 5: 1 October 2006 to 24 June 2016); MEDLINE (1 October 2006 to 8 March 2016); Embase (1 October 2006 to 8 March 2016); CINAHL (2006 to 23 June 2016); AMED (2006 to 21 June 2016) and SPORTSDiscus (2006 to 21 June 2016). Selection criteria: Randomised/quasi-randomised trials in adults after stroke, where the intervention was an active motor sequence performed repetitively within a single training session, aimed towards a clear functional goal. Data collection and analysis: Two review authors independently screened abstracts, extracted data and appraised trials. We determined the quality of evidence within each study and outcome group using the Cochrane 'Risk of bias' tool and GRADE (Grades of Recommendation, Assessment, Development and Evaluation) criteria. We did not assess follow-up outcome data using GRADE. We contacted trial authors for additional information. Main results: We included 33 trials with 36 intervention-control pairs and 1853 participants. The risk of bias present in many studies was unclear due to poor reporting; the evidence has therefore been rated 'moderate' or 'low' when using the GRADE system. There is low-quality evidence that RTT improves arm function (standardised mean difference (SMD) 0.25, 95% confidence interval (CI) 0.01 to 0.49; 11 studies, number of participants analysed = 749), hand function (SMD 0.25, 95% CI 0.00 to 0.51; eight studies, number of participants analysed = 619), and lower limb functional measures (SMD 0.29, 95% CI 0.10 to 0.48; five trials, number of participants analysed = 419). There is moderate-quality evidence that RTT improves walking distance (mean difference (MD) 34.80, 95% CI 18.19 to 51.41; nine studies, number of participants analysed = 610) and functional ambulation (SMD 0.35, 95% CI 0.04 to 0.66; eight studies, number of participants analysed = 525). We found significant differences between groups for both upper-limb (SMD 0.92, 95% CI 0.58 to 1.26; three studies, number of participants analysed = 153) and lower-limb (SMD 0.34, 95% CI 0.16 to 0.52; eight studies, number of participants analysed = 471) outcomes up to six months post treatment but not after six months. Effects were not modified by intervention type, dosage of task practice or time since stroke for upper or lower limb. There was insufficient evidence to be certain about the risk of adverse events. Authors' conclusions: There is low- to moderate-quality evidence that RTT improves upper and lower limb function; improvements were sustained up to six months post treatment. Further research should focus on the type and amount of training, including ways of measuring the number of repetitions actually performed by participants. The definition of RTT will need revisiting prior to further updates of this review in order to ensure it remains clinically meaningful and distinguishable from other interventions.

The Cochrane database of systematic reviews · meta-analysis · 242 citationsread the source →

Yoga for improving health-related quality of life, mental health and cancer-related symptoms in women diagnosed with breast cancer.

Background: Breast cancer is the cancer most frequently diagnosed in women worldwide. Even though survival rates are continually increasing, breast cancer is often associated with long-term psychological distress, chronic pain, fatigue and impaired quality of life. Yoga comprises advice for an ethical lifestyle, spiritual practice, physical activity, breathing exercises and meditation. It is a complementary therapy that is commonly recommended for breast cancer-related impairments and has been shown to improve physical and mental health in people with different cancer types. Objectives: To assess effects of yoga on health-related quality of life, mental health and cancer-related symptoms among women with a diagnosis of breast cancer who are receiving active treatment or have completed treatment. Search methods: We searched the Cochrane Breast Cancer Specialised Register, MEDLINE (via PubMed), Embase, the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 1), Indexing of Indian Medical Journals (IndMED), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal and Clinicaltrials.gov on 29 January 2016. We also searched reference lists of identified relevant trials or reviews, as well as conference proceedings of the International Congress on Complementary Medicine Research (ICCMR), the European Congress for Integrative Medicine (ECIM) and the American Society of Clinical Oncology (ASCO). We applied no language restrictions. Selection criteria: Randomised controlled trials were eligible when they (1) compared yoga interventions versus no therapy or versus any other active therapy in women with a diagnosis of non-metastatic or metastatic breast cancer, and (2) assessed at least one of the primary outcomes on patient-reported instruments, including health-related quality of life, depression, anxiety, fatigue or sleep disturbances. Data collection and analysis: Two review authors independently collected data on methods and results. We expressed outcomes as standardised mean differences (SMDs) with 95% confidence intervals (CIs) and conducted random-effects model meta-analyses. We assessed potential risk of publication bias through visual analysis of funnel plot symmetry and heterogeneity between studies by using the Chi2 test and the I2 statistic. We conducted subgroup analyses for current treatment status, time since diagnosis, stage of cancer and type of yoga intervention. Main results: We included 24 studies with a total of 2166 participants, 23 of which provided data for meta-analysis. Thirteen studies had low risk of selection bias, five studies reported adequate blinding of outcome assessment and 15 studies had low risk of attrition bias. Seventeen studies that compared yoga versus no therapy provided moderate-quality evidence showing that yoga improved health-related quality of life (pooled SMD 0.22, 95% CI 0.04 to 0.40; 10 studies, 675 participants), reduced fatigue (pooled SMD -0.48, 95% CI -0.75 to -0.20; 11 studies, 883 participants) and reduced sleep disturbances in the short term (pooled SMD -0.25, 95% CI -0.40 to -0.09; six studies, 657 participants). The funnel plot for health-related quality of life was asymmetrical, favouring no therapy, and the funnel plot for fatigue was roughly symmetrical. This hints at overall low risk of publication bias. Yoga did not appear to reduce depression (pooled SMD -0.13, 95% CI -0.31 to 0.05; seven studies, 496 participants; low-quality evidence) or anxiety (pooled SMD -0.53, 95% CI -1.10 to 0.04; six studies, 346 participants; very low-quality evidence) in the short term and had no medium-term effects on health-related quality of life (pooled SMD 0.10, 95% CI -0.23 to 0.42; two studies, 146 participants; low-quality evidence) or fatigue (pooled SMD -0.04, 95% CI -0.36 to 0.29; two studies, 146 participants; low-quality evidence). Investigators reported no serious adverse events. Four studies that compared yoga versus psychosocial/educational interventions provided moderate-quality evidence indicating that yoga can reduce depression (pooled SMD -2.29, 95% CI -3.97 to -0.61; four studies, 226 participants), anxiety (pooled SMD -2.21, 95% CI -3.90 to -0.52; three studies, 195 participants) and fatigue (pooled SMD -0.90, 95% CI -1.31 to -0.50; two studies, 106 participants) in the short term. Very low-quality evidence showed no short-term effects on health-related quality of life (pooled SMD 0.81, 95% CI -0.50 to 2.12; two studies, 153 participants) or sleep disturbances (pooled SMD -0.21, 95% CI -0.76 to 0.34; two studies, 119 participants). No trial adequately reported safety-related data. Three studies that compared yoga versus exercise presented very low-quality evidence showing no short-term effects on health-related quality of life (pooled SMD -0.04, 95% CI -0.30 to 0.23; three studies, 233 participants) or fatigue (pooled SMD -0.21, 95% CI -0.66 to 0.25; three studies, 233 participants); no trial provided safety-related data. Authors' conclusions: Moderate-quality evidence supports the recommendation of yoga as a supportive intervention for improving health-related quality of life and reducing fatigue and sleep disturbances when compared with no therapy, as well as for reducing depression, anxiety and fatigue, when compared with psychosocial/educational interventions. Very low-quality evidence suggests that yoga might be as effective as other exercise interventions and might be used as an alternative to other exercise programmes.

The Cochrane database of systematic reviews · meta-analysis · 217 citationsread the source →

Effects of Mindfulness Training and Exercise on Cognitive Function in Older Adults: A Randomized Clinical Trial.

Importance: Episodic memory and executive function are essential aspects of cognitive functioning that decline with aging. This decline may be ameliorable with lifestyle interventions. Objective: To determine whether mindfulness-based stress reduction (MBSR), exercise, or a combination of both improve cognitive function in older adults. Design, setting, and participants: This 2 × 2 factorial randomized clinical trial was conducted at 2 US sites (Washington University in St Louis and University of California, San Diego). A total of 585 older adults (aged 65-84 y) with subjective cognitive concerns, but not dementia, were randomized (enrollment from November 19, 2015, to January 23, 2019; final follow-up on March 16, 2020). Interventions: Participants were randomized to undergo the following interventions: MBSR with a target of 60 minutes daily of meditation (n = 150); exercise with aerobic, strength, and functional components with a target of at least 300 minutes weekly (n = 138); combined MBSR and exercise (n = 144); or a health education control group (n = 153). Interventions lasted 18 months and consisted of group-based classes and home practice. Main outcomes and measures: The 2 primary outcomes were composites of episodic memory and executive function (standardized to a mean [SD] of 0 [1]; higher composite scores indicate better cognitive performance) from neuropsychological testing; the primary end point was 6 months and the secondary end point was 18 months. There were 5 reported secondary outcomes: hippocampal volume and dorsolateral prefrontal cortex thickness and surface area from structural magnetic resonance imaging and functional cognitive capacity and self-reported cognitive concerns. Results: Among 585 randomized participants (mean age, 71.5 years; 424 [72.5%] women), 568 (97.1%) completed 6 months in the trial and 475 (81.2%) completed 18 months. At 6 months, there was no significant effect of mindfulness training or exercise on episodic memory (MBSR vs no MBSR: 0.44 vs 0.48; mean difference, -0.04 points [95% CI, -0.15 to 0.07]; P = .50; exercise vs no exercise: 0.49 vs 0.42; difference, 0.07 [95% CI, -0.04 to 0.17]; P = .23) or executive function (MBSR vs no MBSR: 0.39 vs 0.31; mean difference, 0.08 points [95% CI, -0.02 to 0.19]; P = .12; exercise vs no exercise: 0.39 vs 0.32; difference, 0.07 [95% CI, -0.03 to 0.18]; P = .17) and there were no intervention effects at the secondary end point of 18 months. There was no significant interaction between mindfulness training and exercise (P = .93 for memory and P = .29 for executive function) at 6 months. Of the 5 prespecified secondary outcomes, none showed a significant improvement with either intervention compared with those not receiving the intervention. Conclusions and relevance: Among older adults with subjective cognitive concerns, mindfulness training, exercise, or both did not result in significant differences in improvement in episodic memory or executive function at 6 months. The findings do not support the use of these interventions for improving cognition in older adults with subjective cognitive concerns. Trial registration: ClinicalTrials.gov Identifier: NCT02665481.

JAMA · randomised controlled trial · 109 citationsread the source →

Prospective association of a genetic risk score and lifestyle intervention with cardiovascular morbidity and mortality among individuals with type 2 diabetes: the Look AHEAD randomised controlled trial.

Aims/hypothesis: Both obesity and genetics contribute to cardiovascular disease (CVD). We examined whether a genetic risk score (GRS) prospectively predicted cardiovascular morbidity and mortality among overweight/obese individuals with type 2 diabetes and whether behavioural weight loss could diminish this association. Methods: Look AHEAD (Action for Health in Diabetes) is a randomised controlled trial to determine the effects of intensive lifestyle intervention (ILI), including weight loss and physical activity, relative to diabetes support and education, on cardiovascular outcomes among overweight/obese individuals with type 2 diabetes. Of the participants, 4,016 provided consent for genetic analyses and had DNA samples passing quality control procedures. These secondary data analyses focused on whether a GRS derived from 153 single nucleotide polymorphisms (SNPs) associated with coronary artery disease in the most recent genome-wide association study predicted cardiovascular morbidity and mortality over a median of 9.6 years of follow-up, and whether ILI would diminish this association. Results: The GRS significantly predicted the primary composite endpoint of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalisation for angina in the full sample (HR, 95% CI per 1 SD increase in GRS: 1.19 [1.10, 1.28]) and among individuals with no known history of CVD at baseline (HR 1.18 [95% CI 1.07, 1.30]). In no case did ILI significantly alter this association. Conclusions/interpretation: A GRS comprised of SNPs significantly predicts cardiovascular morbidity and mortality over 9.6 years of follow-up in Look AHEAD. Lifestyle intervention did not alter the genetic association. Clinical trial registration: NCT00017953; NCT01270763.

Diabetologia · randomised controlled trial · 19 citationsread the source →

Engaging Fathers to Increase Physical Activity in Girls: The "Dads And Daughters Exercising and Empowered" (DADEE) Randomized Controlled Trial.

Background: Existing strategies to increase girls' physical activity levels have seen limited success. Fathers may influence their children's physical activity, but often spend more time with their sons and rarely participate in family-based programs. Purpose: To test a novel program designed to increase the physical activity levels of fathers and their daughters. Methods: In a two-arm RCT, 115 fathers (29-53 years) and 153 daughters (4-12 years) were randomized to (i) the "Dads And Daughters Exercising and Empowered" (DADEE) program, or (ii) a wait-list control. The 8-week program included weekly educational and practical sessions plus home tasks. Assessments were at baseline, 2 months (postintervention), and 9 months. The primary outcomes were father-daughter physical activity levels (pedometry). Secondary outcomes included screen-time, daughters' fundamental movement skill proficiency (FMS: perceived and objective), and fathers' physical activity parenting practices. Results: Primary outcome data were obtained from 88% of daughters and 90% of fathers at 9 months. Intention-to-treat analyses revealed favorable group-by-time effects for physical activity in daughters (p = .02, d = 0.4) and fathers (p < .001, d = 0.7) at postintervention, which were maintained at 9 months. At postintervention and follow-up, significant effects (p < .05) were also identified for daughters' FMS competence (objective: d = 1.1-1.2; perceived: d = 0.4-0.6), a range of fathers' physical activity parenting practices (d = 0.3-0.8), and screen-time for daughters (d = 0.5-0.8) and fathers (d = 0.4-0.6, postintervention only). Program satisfaction and attendance were very high. Conclusions: This study provided the first experimental evidence that efforts to increase physical activity behavior in preadolescent girls would benefit from a meaningful engagement of fathers. Clinical Trial information: Australian New Zealand Clinical Trials Registry: ACTRN12615000022561.

Annals of behavioral medicine : a publication of the Society of Behavioral Medicine · randomised controlled trial · 86 citationsread the source →

Effect of Cognitive Bias Modification on Early Relapse Among Adults Undergoing Inpatient Alcohol Withdrawal Treatment: A Randomized Clinical Trial.

Importance: More than half of patients with alcohol use disorder who receive inpatient withdrawal treatment relapse within weeks of discharge, hampering subsequent uptake and effectiveness of psychological and pharmacologic interventions. Cognitive bias modification (CBM) improves outcomes after alcohol rehabilitation, but the efficacy of delivering CBM during withdrawal treatment has not yet been established. Objective: To test the hypothesis that CBM would increase the likelihood of abstaining from alcohol during the 2 weeks following discharge from inpatient withdrawal treatment. Design, setting, and participants: In a randomized clinical trial, 950 patients in 4 inpatient withdrawal units in Melbourne, Australia, were screened for eligibility between June 4, 2017, and July 14, 2019, to receive CBM or sham treatment. Patients with moderate or severe alcohol use disorder aged 18 to 65 years who had no neurologic illness or traumatic brain injury were eligible. Two-week follow-up, conducted by researchers blinded to the participant's condition, was the primary end point. Both per-protocol and intention-to-treat analysis were conducted. Interventions: Randomized to 4 consecutive daily sessions of CBM designed to reduce alcohol approach bias or sham training not designed to modify approach bias. Main outcomes and measures: Primary outcome was abstinence assessed using a timeline followback interview. Participants were classified as abstinent (no alcohol use in the first 14 days following discharge) or relapsed (any alcohol use during the first 14 days following discharge or lost to follow-up). Results: Of the 950 patients screened for eligibility, 338 did not meet inclusion criteria, 108 were discharged before being approached, and 192 refused. Of the 312 patients who consented (referred sample), 12 withdrew before being randomized. In the final population of 300 randomized patients (CBM, n = 147; sham, n = 153), 248 completed the intervention and 272 completed the follow-up. Of the 300 participants (173 [57.7%] men; mean [SD] age, 43.47 [10.43] years), 7 patients (3 controls, 4 CBM) withdrew after finding the training uncomfortable. Abstinence rates were 42.5% (95% CI, 34.3%-50.6%) in controls and 54.4% (95% CI, 46.0%-62.8%) in CBM participants, yielding an 11.9% (95% CI, 0.04%-23.8%; P = .04) difference in abstinence rates. In a per-protocol analysis including only those who completed 4 sessions of training and the follow-up, the difference in abstinence rate between groups was 17.0% (95% CI, 3.8%-30.2%; P = .008). Conclusions and relevance: The findings of this clinical trial support the efficacy of CBM for treatment of alcohol use disorder. Being safe and easy to implement, requiring only a computer and joystick, and needing no specialist staff/training, CBM could be routinely offered as an adjunctive intervention during withdrawal treatment to optimize outcomes. Trial registration: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12617001241325.

JAMA psychiatry · randomised controlled trial · 67 citationsread the source →

A multilevel, multicomponent childhood obesity prevention group-randomized controlled trial improves healthier food purchasing and reduces sweet-snack consumption among low-income African-American youth.

Background: Consumption of foods and beverages rich in sugar remains high across all races and ages in the United States. Interventions to address childhood obesity and decrease sugar intake are needed, particularly in low-income settings. Methods: B'more Healthy Communities for Kids (BHCK) was a group-randomized, controlled trial implemented among 9-15-year olds in 30 low-income areas of Baltimore. We increased access to low-sugar foods and beverages at wholesalers and small food stores. Concurrently, we encouraged their purchase and consumption by children through youth-led nutrition education in recreation centers, in-store promotions, text messaging and a social media program directed at caregivers. Sugar consumption (sugar sweetened beverage (SSB), sweets) in youth was assessed pre- (n = 534) and post-intervention (n = 401) using the Block Kids Food Frequency Questionnaire. Purchasing of 38 healthier and 28 less healthier food/beverage varieties in the previous 7 days was assessed via self-report. Multilevel models at the community and individual levels were used. Analyses were stratified by age (younger: 9-12-year olds (n = 339) vs older: 13-15 (n = 170)). Models were controlled for child's sex, race, total daily caloric intake, and caregiver's age and sex. Results: Overall baseline mean healthier food purchasing was 2.5 (+ 3.6; min. 0, max. 34 items per week), and unhealthier food purchasing 4.6 (+ 3.7; 0-19 items per week). Mean intake at baseline for kcal from SSB was 176 (+ 189.1) and 153 (+ 142.5), and % of calories from sweets (i.e. cookies, cakes, pies, donuts, candy, ice cream, sweetened cereals, and chocolate beverages) was 15.9 (+ 9.7) and 15.9 (+ 7.7) in comparison and intervention youth, respectively. Intervention youth increased healthier foods and beverages purchases by 1.4 more items per week than comparison youth (β = 1.4; 95% CI: 0.1; 2.8). After the intervention, there was a 3.5% decrease in kcal from sweets for older intervention youth, compared to the control group (β = - 3.5; 95% CI: -7.76; - 0.05). No impact was seen on SSB consumption. Conclusion: BHCK successfully increased healthier food purchasing variety in youth, and decreased % calories from sweet snacks in older youth. Multilevel, multicomponent environmental childhood obesity programs are a promising strategy to improve eating behaviors among low-income urban youth. Trial registration: NCT02181010 (July 2, 2014, retrospectively registered).

Nutrition journal · randomised controlled trial · 47 citationsread the source →

Clinical effectiveness and acceptability of structured group psychoeducation versus optimised unstructured peer support for patients with remitted bipolar disorder (PARADES): a pragmatic, multicentre, observer-blind, randomised controlled superiority trial.

Background: Group psychoeducation is a low-cost National Institute for Health and Care Excellence-recommended treatment for bipolar disorder. However, the clinical effectiveness and acceptability of this intervention are unclear compared with unstructured peer support matched for delivery and aim of treatment, and for previous bipolar history. We aimed to assess the clinical effectiveness and acceptability of structured group psychoeducation versus optimised unstructured peer support for patients with remitted bipolar disorder. Methods: We did this pragmatic, multicentre, parallel-group, observer-blind, randomised controlled superiority trial at eight community sites in two regions in England. Participants aged 18 years or older with bipolar disorder and no episode in the preceding 4 weeks were recruited via self-referral or secondary care referral. Participants were individually randomly assigned (1:1), via a computer-generated stochastic allocation sequence, to attend 21 2-h weekly sessions of either structured group psychoeducation or optimised unstructured peer support. Randomisation was minimised by number of previous episodes (one to seven, eight to 19, or ≥20) and stratified by clinical site. Outcome assessors were masked to group allocation. The primary outcome was time from randomisation to next bipolar episode, with planned moderator analysis of number of previous bipolar episodes and qualitative interview of participant experience. We did analysis by intention to treat. This trial is registered with the International Standard Randomised Controlled Trial registry, number ISRCTN62761948. Findings: Between Sept 28, 2009, and Jan 9, 2012, we randomly assigned 304 participants to receive psychoeducation (n=153) or peer support (n=151); all (100%) participants had complete primary outcome data. Attendance at psychoeducation groups was higher than at peer-support groups (median 14 sessions [IQR three to 18] vs nine sessions [two to 17]; p=0·026). At 96 weeks, 89 (58%) participants in the psychoeducation group had experienced a next bipolar episode compared with 98 (65%) participants in the peer-support group; time to next bipolar episode did not differ between groups (hazard ratio [HR] 0·83, 95% CI 0·62-1·11; p=0·217). Planned moderator analysis showed that psychoeducation was most beneficial in participants with few (one to seven) previous bipolar episodes (χ2; HR 0·28, 95% CI 0·12-0·68; p=0·034). Four (1%) participants (one in the psychoeducation group and three in the peer-support group) died during follow-up; these deaths were deemed unrelated to the study interventions or procedures. Interpretation: Structured group psychoeducation was no more clinically effective than similarly intensive unstructured peer support, but was more acceptable and improved outcome in participants with fewer previous bipolar episodes. Optimum provision of structured psychological interventions, such as group psychoeducation, early in the course of bipolar disorder might have important benefits on the course of illness, and merits further research. Funding: National Institute for Health Research.

The lancet. Psychiatry · randomised controlled trial · 42 citationsread the source →

'Dear Doctor': a randomised controlled trial of a text message intervention to reduce burnout in trainee anaesthetists.

One in four doctors in training in the UK reports feeling 'burnt out' due to their work and similar figures are reported in other countries. This two-group non-blinded randomised controlled trial aimed to determine if a novel text message intervention could reduce burnout and increase well-being in UK trainee anaesthetists. A total of 279 trainee anaesthetists (Core Training Year 2, Specialty Training Years 3 or 4) were included. All participants received one initial message sharing support resources. The intervention group (139 trainees) received 22 fortnightly text messages over approximately 10 months. Messages drew on 11 evidence-based themes including: gratitude; social support; self-efficacy; and self-compassion. Primary outcomes were burnout (Copenhagen Burnout Inventory) and well-being (Short Warwick-Edinburgh Mental Well-being Scale). Secondary outcomes were as follows: meaning in work; professional value; sickness absence; and consideration of career break. Outcomes were measured via online surveys. Measures of factors that may have affected well-being were included post-hoc, including the impact of COVID-19 (the first UK wave of which coincided with the second half of the trial). The final survey was completed by 153 trainees (74 in the intervention and 79 in the control groups). There were no significant group differences in: burnout (β = -1.82, 95%CI -6.54-2.91, p = 0.45); well-being (-0.52, -1.73-0.69, p = 0.40); meaning (-0.09, -0.67-0.50, p = 0.77); value (-0.01, -0.67-0.66, p = 0.99); sick days (0.88, -2.08-3.83, p = 0.56); or consideration of career break (OR = 0.44, -0.30-1.18, p = 0.24). Exploratory post-hoc analysis found the intervention was associated with reduced burnout in participants reporting personal or work-related difficulties during the trial period (-9.56, -17.35 to -1.77, p = 0.02) and in participants reporting that the COVID-19 pandemic had a big negative impact on their well-being (-10.38, -20.57 to -0.19, p = 0.05). Overall, this trial found the intervention had no impact. However, given this intervention is low cost and requires minimal time commitment from recipients, it may warrant adaptation and further evaluation.

Anaesthesia · randomised controlled trial · 10 citationsread the source →

Empagliflozin in Heart Failure: Diuretic and Cardiorenal Effects.

Background: Sodium-glucose cotransporter-2 inhibitors improve heart failure-related outcomes. The mechanisms underlying these benefits are not well understood, but diuretic properties may contribute. Traditional diuretics such as furosemide induce substantial neurohormonal activation, contributing to the limited improvement in intravascular volume often seen with these agents. However, the proximal tubular site of action of the sodium-glucose cotransporter-2 inhibitors may help circumvent these limitations. Methods: Twenty patients with type 2 diabetes mellitus and chronic, stable heart failure completed a randomized, placebo-controlled crossover study of empagliflozin 10 mg daily versus placebo. Patients underwent an intensive 6-hour biospecimen collection and cardiorenal phenotyping at baseline and again after 14 days of study drug. After a 2-week washout, patients crossed over to the alternate therapy with the above protocol repeated. Results: Oral empagliflozin was rapidly absorbed as evidenced by a 27-fold increase in urinary glucose excretion by 3 hours (P<0.0001). Fractional excretion of sodium increased significantly with empagliflozin monotherapy versus placebo (fractional excretion of sodium, 1.2±0.7% versus 0.7±0.4%; P=0.001), and there was a synergistic effect in combination with bumetanide (fractional excretion of sodium, 5.8±2.5% versus 3.9±1.9%; P=0.001). At 14 days, the natriuretic effect of empagliflozin persisted, resulting in a reduction in blood volume (-208 mL [interquartile range, -536 to 153 mL] versus -14 mL [interquartile range, -282 to 335 mL]; P=0.035) and plasma volume (-138 mL, interquartile range, -379 to 154±453 mL; P=0.04). This natriuresis was not, however, associated with evidence of neurohormonal activation because the change in norepinephrine was superior (P=0.02) and all other neurohormones were similar (P<0.34) during the empagliflozin versus placebo period. Furthermore, there was no evidence of potassium wasting (P=0.20) or renal dysfunction (P>0.11 for all biomarkers), whereas both serum magnesium (P<0.001) and uric acid levels (P=0.008) improved. Conclusions: Empagliflozin causes significant natriuresis, particularly when combined with loop diuretics, resulting in an improvement in blood volume. However, off-target electrolyte wasting, renal dysfunction, and neurohormonal activation were not observed. This favorable diuretic profile may offer significant advantage in the management of volume status in patients with heart failure and may represent a mechanism contributing to the superior long-term heart failure outcomes observed with these agents. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03027960.

Circulation · randomised controlled trial · 322 citationsread the source →

Classifying eating disorders based on "healthy" and "unhealthy" perfectionism and impulsivity.

Objective: Perfectionism and impulsivity are associated with eating disorders (EDs). The current study examines whether clinically relevant subgroups of women with EDs can be identified based on "healthy" and "unhealthy" perfectionism and impulsivity. Method: Latent profile analyses (LPA) were performed on data of 844 patients (DSM-IV diagnosis: 381 anorexia nervosa, 146 bulimia nervosa, 56 binge-eating disorder, 261 ED not otherwise specified). "Healthy" and "unhealthy" forms of perfectionism and impulsivity were assessed by the Frost Multidimensional Perfectionism Scale and the Dickman Impulsivity Inventory, respectively. The Eating Disorder Examination Questionnaire was completed to assess ED psychopathology. Furthermore, in 229 patients additional ED symptoms, depression, self-esteem, obsessive-compulsive symptoms, and personality features were assessed. Results: The LPA revealed four profiles; 1. "Healthy Impulsivity" (HI; n = 191), 2. "Unhealthy Impulsivity" (UI; n = 238), 3. "Healthy and Unhealthy Perfectionism" (HP + UP; n = 153), 4. "Healthy Perfectionism" (HP; n = 262). Patients belonging to the "HP + UP" and the "UI" classes reported higher levels of ED psychopathology. More severe comorbid symptoms (depressive, obsessive-compulsive and self-esteem) were found in the patients belonging to the "HP + UP" class. Patients from the "HP + UP" and "HP" classes had higher scores for the personality features Harm Avoidance, Persistence and Cooperativeness. Discussion: Women with EDs could be meaningfully grouped according to perfectionism and impulsivity. These findings can be used to improve treatment matching and intervention strategies. The use of dimensional features, like perfectionism and impulsivity, in ED research, may enable the identification of fundamental underlying mechanisms and provide more insight into potential mechanisms that may drive or maintain disordered eating. © 2016 Wiley Periodicals, Inc. (Int J Eat Disord 2016; 49:673-680).

The International journal of eating disorders · cohort or longitudinal · 27 citationsread the source →

Factors associated with attrition from a randomized controlled trial of meaning-centered group psychotherapy for patients with advanced cancer.

Objective: The generalizability of palliative care intervention research is often limited by high rates of study attrition. This study examined factors associated with attrition from a randomized controlled trial comparing meaning-centered group psychotherapy (MCGP), an intervention designed to help advanced cancer patients sustain or enhance their sense of meaning to the supportive group psychotherapy (SGP), a standardized support group. Methods: Patients with advanced solid tumor cancers (n = 153) were randomized to eight sessions of either the MCGP or SGP. They completed assessments of psychosocial, spiritual, and physical well-being pretreatment, midtreatment, and 2 months post-treatment. Attrition was assessed in terms of the percent of participants who failed to complete these assessments, and demographic, psychiatric, medical, and study-related correlates of attrition were examined for the participants in each of these categories. Results: The rates of attrition at these time points were 28.1%, 17.7%, and 11.1%, respectively; 43.1% of the participants (66 of 153) completed the entire study. The most common reason for dropout was patients feeling too ill. Attrition rates did not vary significantly between study arms. The participants who dropped out pretreatment reported less financial concerns than post-treatment dropouts, and the participants who dropped out of the study midtreatment had poorer physical health than treatment completers. There were no other significant associations between attrition and any demographic, medical, psychiatric, or study-related variables. Conclusions: These findings highlight the challenge of maintaining advanced cancer patients in longitudinal research and suggest the need to consider alternative approaches (e.g., telemedicine) for patients who might benefit from group interventions but are too ill to travel.

Psycho-oncology · randomised controlled trial · 54 citationsread the source →

Community based physiotherapeutic exercise in COPD self-management: a randomised controlled trial.

Little is known about effects of community-based physiotherapeutic exercise programmes incorporated in COPD self-management programmes. In a randomised trial, the effect of such a programme (COPE-active) on exercise capacity and various secondary outcomes including daily activity as a marker of behaviour change was evaluated. All patients attended four 2-h self-management sessions. In addition the intervention group participated in the COPE-active programme offered by physiotherapists of private practices, consisting of a 6-month "compulsory" period (3 sessions/week) and subsequently a 5-month "optional" period (2 sessions/week). Because COPE-active was intended to change behaviour with regard to exercise, one session/week in both periods consisted of unsupervised home-based exercise training. Of 153 patients, 74 intervention and 68 control patients completed the one-year follow-up. Statistically significant between-group differences in incremental shuttle walk test-distance (35.1 m; 95% CI (8.4; 61.8)) and daily activity (1190 steps/day; 95% CI (256; 2125)) were found in favour of the intervention group. Over the 12-month period a significant difference of the chronic respiratory questionnaire (CRQ) dyspnoea-score (0.33 points; 95% CI (0.01; 0.64)) and a non-significant difference of the endurance shuttle walk test (135 m (95% CI (-29; 298)) was found. No differences were found in the other CRQ-components, anxiety and depression scores and percentage of fat free mass. This study demonstrates that a community-based reactivation programme improves exercise capacity in patients with moderately to severe COPD. Even more important, the programme improves actual daily activity after one-year which indicates behaviour change with regard to daily exercise. Registered trail number: ISRCTN81447311.

Respiratory medicine · randomised controlled trial · 83 citationsread the source →

Effectiveness of collaborative care for older adults with Alzheimer disease in primary care: a randomized controlled trial.

Context: Most older adults with dementia will be cared for by primary care physicians, but the primary care practice environment presents important challenges to providing quality care. Objective: To test the effectiveness of a collaborative care model to improve the quality of care for patients with Alzheimer disease. Design, setting, and patients: Controlled clinical trial of 153 older adults with Alzheimer disease and their caregivers who were randomized by physician to receive collaborative care management (n = 84) or augmented usual care (n = 69) at primary care practices within 2 US university-affiliated health care systems from January 2002 through August 2004. Eligible patients (identified via screening or medical record) met diagnostic criteria for Alzheimer disease and had a self-identified caregiver. Intervention: Intervention patients received 1 year of care management by an interdisciplinary team led by an advanced practice nurse working with the patient's family caregiver and integrated within primary care. The team used standard protocols to initiate treatment and identify, monitor, and treat behavioral and psychological symptoms of dementia, stressing nonpharmacological management. Main outcome measures: Neuropsychiatric Inventory (NPI) administered at baseline and at 6, 12, and 18 months. Secondary outcomes included the Cornell Scale for Depression in Dementia (CSDD), cognition, activities of daily living, resource use, and caregiver's depression severity. Results: Initiated by caregivers' reports, 89% of intervention patients triggered at least 1 protocol for behavioral and psychological symptoms of dementia with a mean of 4 per patient from a total of 8 possible protocols. Intervention patients were more likely to receive cholinesterase inhibitors (79.8% vs 55.1%; P = .002) and antidepressants (45.2% vs 27.5%; P = .03). Intervention patients had significantly fewer behavioral and psychological symptoms of dementia as measured by the total NPI score at 12 months (mean difference, -5.6; P = .01) and at 18 months (mean difference, -5.4; P = .01). Intervention caregivers also reported significant improvements in distress as measured by the caregiver NPI at 12 months; at 18 months, caregivers showed improvement in depression as measured by the Patient Health Questionnaire-9. No group differences were found on the CSDD, cognition, activities of daily living, or on rates of hospitalization, nursing home placement, or death. Conclusions: Collaborative care for the treatment of Alzheimer disease resulted in significant improvement in the quality of care and in behavioral and psychological symptoms of dementia among primary care patients and their caregivers. These improvements were achieved without significantly increasing the use of antipsychotics or sedative-hypnotics. Trial registration: clinicaltrials.gov Identifier: NCT00246896.

JAMA · randomised controlled trial · 534 citationsread the source →

Long-term quality-of-life outcomes after radical prostatectomy or watchful waiting: the Scandinavian Prostate Cancer Group-4 randomised trial.

Background: For men with localised prostate cancer, surgery provides a survival benefit compared with watchful waiting. Treatments are associated with morbidity. Results for functional outcome and quality of life are rarely reported beyond 10 years and are lacking from randomised settings. We report results for quality of life for men in the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) after a median follow-up of more than 12 years. Methods: All living Swedish and Finnish men (400 of 695) randomly assigned to radical prostatectomy or watchful waiting in SPCG-4 from 1989 to 1999 were included in our analysis. An additional 281 men were included in a population-based control group matched for region and age. Physical symptoms, symptom-induced stress, and self-assessed quality of life were evaluated with a study-specific questionnaire. Longitudinal data were available for 166 Swedish men who had answered quality-of-life questionnaires at an earlier timepoint. Findings: 182 (88%) of 208 men in the radical prostatectomy group, 167 (87%) of 192 men in the watchful-waiting group, and 214 (76%) of 281 men in the population-based control group answered the questionnaire. Men in SPCG-4 had a median follow-up of 12·2 years (range 7-17) and a median age of 77·0 years (range 61-88). High self-assessed quality of life was reported by 62 (35%) of 179 men allocated radical prostatectomy, 55 (34%) of 160 men assigned to watchful waiting, and 93 (45%) of 208 men in the control group. Anxiety was higher in the SPCG-4 groups (77 [43%] of 178 and 69 [43%] of 161 men) than in the control group (68 [33%] of 208 men; relative risk 1·42, 95% CI 1·07-1·88). Prevalence of erectile dysfunction was 84% (146 of 173 men) in the radical prostatectomy group, 80% (122 of 153) in the watchful-waiting group, and 46% (95 of 208) in the control group and prevalence of urinary leakage was 41% (71 of 173), 11% (18 of 164), and 3% (six of 209), respectively. Distress caused by these symptoms was reported significantly more often by men allocated radical prostatectomy than by men assigned to watchful waiting. In a longitudinal analysis of men in SPCG-4 who provided information at two follow-up points 9 years apart, 38 (45%) of 85 men allocated radical prostatectomy and 48 (60%) of 80 men allocated watchful waiting reported an increase in number of physical symptoms; 50 (61%) of 82 and 47 (64%) of 74 men, respectively, reported a reduction in quality of life. Interpretation: For men in SPCG-4, negative side-effects were common and added more stress than was reported in the control population. In the radical prostatectomy group, erectile dysfunction and urinary leakage were often consequences of surgery. In the watchful-waiting group, side-effects can be caused by tumour progression. The number and severity of side-effects changes over time at a higher rate than is caused by normal ageing and a loss of sexual ability is a persistent psychological problem for both interventions. An understanding of the patterns of side-effects and time dimension of their occurrence for each treatment is important for full patient information. Funding: US National Institutes of Health; Swedish Cancer Society; Foundation in Memory of Johanna Hagstrand and Sigfrid Linnér.

The Lancet. Oncology · randomised controlled trial · 277 citationsread the source →

Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010.

Background: We used data from the Global Burden of Diseases, Injuries, and Risk Factors Study 2010 (GBD 2010) to estimate the burden of disease attributable to mental and substance use disorders in terms of disability-adjusted life years (DALYs), years of life lost to premature mortality (YLLs), and years lived with disability (YLDs). Methods: For each of the 20 mental and substance use disorders included in GBD 2010, we systematically reviewed epidemiological data and used a Bayesian meta-regression tool, DisMod-MR, to model prevalence by age, sex, country, region, and year. We obtained disability weights from representative community surveys and an internet-based survey to calculate YLDs. We calculated premature mortality as YLLs from cause of death estimates for 1980-2010 for 20 age groups, both sexes, and 187 countries. We derived DALYs from the sum of YLDs and YLLs. We adjusted burden estimates for comorbidity and present them with 95% uncertainty intervals. Findings: In 2010, mental and substance use disorders accounted for 183·9 million DALYs (95% UI 153·5 million-216·7 million), or 7·4% (6·2-8·6) of all DALYs worldwide. Such disorders accounted for 8·6 million YLLs (6·5 million-12·1 million; 0·5% [0·4-0·7] of all YLLs) and 175·3 million YLDs (144·5 million-207·8 million; 22·9% [18·6-27·2] of all YLDs). Mental and substance use disorders were the leading cause of YLDs worldwide. Depressive disorders accounted for 40·5% (31·7-49·2) of DALYs caused by mental and substance use disorders, with anxiety disorders accounting for 14·6% (11·2-18·4), illicit drug use disorders for 10·9% (8·9-13·2), alcohol use disorders for 9·6% (7·7-11·8), schizophrenia for 7·4% (5·0-9·8), bipolar disorder for 7·0% (4·4-10·3), pervasive developmental disorders for 4·2% (3·2-5·3), childhood behavioural disorders for 3·4% (2·2-4·7), and eating disorders for 1·2% (0·9-1·5). DALYs varied by age and sex, with the highest proportion of total DALYs occurring in people aged 10-29 years. The burden of mental and substance use disorders increased by 37·6% between 1990 and 2010, which for most disorders was driven by population growth and ageing. Interpretation: Despite the apparently small contribution of YLLs--with deaths in people with mental disorders coded to the physical cause of death and suicide coded to the category of injuries under self-harm--our findings show the striking and growing challenge that these disorders pose for health systems in developed and developing regions. In view of the magnitude of their contribution, improvement in population health is only possible if countries make the prevention and treatment of mental and substance use disorders a public health priority. Funding: Queensland Department of Health, National Health and Medical Research Council of Australia, National Drug and Alcohol Research Centre-University of New South Wales, Bill & Melinda Gates Foundation, University of Toronto, Technische Universität, Ontario Ministry of Health and Long Term Care, and the US National Institute of Alcohol Abuse and Alcoholism.

Lancet (London, England) · review · 3758 citationsread the source →

What makes adults with hearing impairment take up hearing AIDS or communication programs and achieve successful outcomes?

Objectives: Client involvement in health decision making, or shared decision making, is increasingly being advocated. For example, rehabilitation interventions such as hearing aids and communication programs can be presented as options to adults with hearing impairment seeking help for the first time. Our previous research focused on the predictors of intervention decisions when options were presented with a decision aid. However, not all participants took up the intervention they initially decided upon. Although it is interesting to understand what informs adults with hearing impairment's intervention decisions, it is their intervention uptake and outcomes which best represent the ultimate end result of the rehabilitation process. This prospective study investigated the predictors of uptake and of successful outcomes of hearing aids and communication programs in middle-aged and older adults with hearing impairment seeking help for the first time. Design: Using shared decision making, 153 participants with hearing impairment (average of air conduction thresholds at 0.5, 1, 2, and 4 kHz greater than 25 dB HL in at least one ear) aged 50 yr and older were presented with intervention options: hearing aids, communication programs (group or individual), and no intervention. Each participant received a decision aid and had at least 1 wk to consider intervention options before the intervention decision was made. Outcome measures for both hearing aids and communication programs at 3 mo after intervention completion were benefit (measured with the Client-Oriented Scale of Improvement), composite outcomes (measured with the International Outcome Inventory), and reduction in self-reported hearing disability (measured with the Hearing Handicap Questionnaire). Multivariate analysis (logistic and linear regression) identified predictors of intervention uptake and of successful outcomes when all other variables were held constant. Results: Almost a quarter of the 153 participants (24%) did not take up the intervention they initially decided upon: 6 mo after making their intervention decision, 66 participants (43%) obtained hearing aids, 28 participants (18%) completed communication programs, and 59 participants (39%) did not complete an intervention. Seven intervention uptake predictors were identified: (1) application for subsidized hearing services (participants more likely to obtain hearing aids and less likely to complete no intervention); (2) higher socioeconomic status (no intervention less likely); (3) greater communication self-efficacy (hearing aids less likely); (4) greater contemplation stage of change (no intervention less likely); (5) greater hearing disability perceived by others and self (communication programs less likely); (6) greater perceived communication program effectiveness (communication programs more likely); and (7) greater perceived suitability of individual communication program (hearing aids less likely and communication programs more likely). Six predictors of successful intervention outcomes were identified: (1) higher socioeconomic status; (2) greater initial self-reported hearing disability; (3) lower precontemplation stage of change; (4) greater action stage of change; (5) lower chance locus of control; and (6) greater hearing disability perceived by others and self. Conclusions: Self-reported hearing disability and stages of change are the two most robust predictors of intervention uptake and successful outcomes. Clinicians should offer intervention options and should discuss these predictors when helping adults with hearing impairment make optimal decisions.

Ear and hearing · 76 citationsread the source →

Digital Mental Health Intervention Plus Usual Care Compared With Usual Care Only and Usual Care Plus In-Person Psychological Counseling for Orthopedic Patients With Symptoms of Depression or Anxiety: Cohort Study.

Background: Depression and anxiety frequently coexist with chronic musculoskeletal pain and can negatively impact patients' responses to standard orthopedic treatments. Nevertheless, mental health is not routinely addressed in the orthopedic care setting. If effective, a digital mental health intervention may be a feasible and scalable method of addressing mental health in an orthopedic setting. Objective: We aimed to compare 2-month changes in mental and physical health between orthopedic patients who received a digital mental health intervention in addition to usual orthopedic care, those who received usual orthopedic care only (without a specific mental health intervention), and those who received in-person care with a psychologist as part of their orthopedic treatment plan. Methods: In this single-center retrospective cohort study involving ancillary analysis of a pilot feasibility study, 2-month self-reported health changes were compared between a cohort of orthopedic patients who received access to a digital mental health intervention (Wysa) and 2 convenience sample comparison cohorts (patients who received usual orthopedic care without a specific mental health intervention and patients who received in-person care with a psychologist as part of their orthopedic treatment plan). All patients were 18 years or older and reported elevated symptoms of depression or anxiety at an orthopedic clinic visit (Patient-Reported Outcomes Measurement Information System [PROMIS] Depression or Anxiety score ≥55). The digital intervention was a multi-component mobile app that used chatbot technology and text-based access to human counselors to provide cognitive behavioral therapy, mindfulness training, and sleep tools, among other features, with an emphasis on behavioral activation and pain acceptance. Outcomes of interest were between-cohort differences in the 2-month longitudinal changes in PROMIS Depression and Anxiety scores (primary outcomes) and PROMIS Pain Interference and Physical Function scores (secondary outcomes). Results: Among 153 patients (mean age 55, SD 15 years; 128 [83.7%] female; 51 patients per cohort), patients who received the digital mental health intervention showed clinically meaningful improvements at the 2-month follow-up for all PROMIS measures (mean longitudinal improvement 2.8-3.7 points; P≤.02). After controlling for age and BMI, the improvements in PROMIS Depression, Pain Interference, and Physical Function were meaningfully greater than longitudinal changes shown by patients who received usual orthopedic care (mean between-group difference 2.6-4.8 points; P≤.04). Improvements in PROMIS Physical Function were also meaningfully greater than longitudinal changes shown by patients who received in-person psychological counseling (mean between-group difference 2.4 points; P=.04). Conclusions: Patients who received a digital mental health intervention as part of orthopedic care reported greater 2-month mean improvements in depression, pain interference, and physical function than patients who received usual orthopedic care. They also reported a greater mean improvement in physical function and comparable improvements in depression, anxiety, and pain interference compared with orthopedic patients who received in-person psychological counseling.

JMIR formative research · 24 citationsread the source →

Long-term followup of bulbar end-to-end anastomosis: a retrospective analysis of 153 patients in a single center experience.

Purpose: We performed a retrospective evaluation and statistical analysis of outcome in patients who underwent bulbar end-to-end anastomosis. Materials and methods: We reviewed 153 patients with an average age of 39 years who underwent bulbar end-to-end anastomosis between 1988 and 2006. Mean followup was 68 months. Stricture etiology was unknown (62.7%), catheter (14.4%), blunt perineal trauma (11.7%), instrumentation (9.8%), radiotherapy (0.7%) and infection (0.7%). Stricture length was 1 to 2 cm (in 59.5%), 2 to 3 cm (37.9%), 3 to 4 cm (1.9%) or 4 to 5 cm (0.7%). A total of 90 patients (59%) underwent dilation, internal urethrotomy, urethroplasty or multiple procedures before being referred to our center. Clinical outcome was considered a treatment failure when any postoperative instrumentation was needed. The prevalence of postoperative sexual dysfunction was investigated using a nonvalidated questionnaire. Results: Of 153 cases 139 (90.8%) were successful and 14 (9.2%) were treatment failures. Treatment failure was managed with urethrotomy in 9 cases, end-to-end anastomosis in 2, buccal mucosal graft urethroplasty in 1 and 2-stage repair in 2. Of 14 cases of failure 12 had a satisfactory final outcome, 1 is still waiting for the second stage of urethroplasty and 1 underwent definitive perineostomy. There were 14 patients (23.3%) who experienced ejaculatory dysfunction, 1 (1.6%) a cold glans during erection, 7 (11.6%) a glans that was neither full nor swollen during erection and 11 (18.3%) had decreased glans sensitivity. No patients complained of penile chordee or impotence. Conclusions: Bulbar end-to-end anastomosis has a success rate of 90.8%. Most patients were satisfied with the surgical outcome despite postoperative complications such as ejaculatory dysfunction, a glans that was neither full nor swollen during erection, or decreased penile sensitivity.

The Journal of urology · 124 citationsread the source →

Self-management for obesity and cardio-metabolic fitness: description and evaluation of the lifestyle modification program of a randomised controlled trial.

Background: Sustainable lifestyle modification strategies are needed to address obesity and cardiovascular risk factors. Intensive, individualised programs have been successful, but are limited by time and resources. We have formulated a group-based lifestyle education program based upon national diet and physical activity (PA) recommendations to manage obesity and cardio-metabolic risk factors. This article describes the content and delivery of this program, with information on compliance and acceptability. Methods: Overweight/obese adults (n = 153) with metabolic syndrome were recruited from the community and randomly allocated to intervention (INT) or control (CON). Written copies of Australian national dietary and PA guidelines were provided to all participants. INT took part in a 16-week lifestyle program which provided a curriculum and practical strategies on 1) dietary and PA information based on national guidelines, 2) behavioural self-management tools, 3) food-label reading, supermarkets tour and cooking, 4) exercise sessions, and 5) peer-group support. Compliance was assessed using attendance records and weekly food/PA logs. Participants' motivations, perceived benefits and goals were assessed through facilitated discussion. Program acceptability feedback was collected through structured focus groups. Results: Although completion of weekly food/PA records was poor, attendance at information/education sessions (77% overall) and exercise participation (66% overall) was high, and compared with CON, multiple markers of body composition and cardio-metabolic health improved in INT. Participants reported that the most useful program components included food-label reading, cooking sessions, and learning new and different physical exercises, including home-based options. Participants also reported finding self-management techniques helpful, namely problem solving and short-term goal setting. The use of a group setting and supportive 'peer' leaders were found to be supportive. More frequent clinical assessment was suggested for future programs. Conclusion: This group-based lifestyle program achieved improvements in body composition and cardio-metabolic and physical fitness similar to individualised interventions which are more resource intensive to deliver. It confirmed that active training in lifestyle modification is more effective than passive provision of guidelines. Such programs should include social support and self-management techniques. Continued clinical follow up may be required for long-term maintenance in individuals attempting lifestyle behaviour change. Program facilitation by peers may help and should be further investigated in a community-based model.

The international journal of behavioral nutrition and physical activity · 31 citationsread the source →