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Effectiveness of Family Integrated Care in neonatal intensive care units on infant and parent outcomes: a multicentre, multinational, cluster-randomised controlled trial.

Background: Despite evidence suggesting that parent involvement was beneficial for infant and parent outcomes, the Family Integrated Care (FICare) programme was one of the first pragmatic approaches to enable parents to become primary caregivers in the neonatal intensive care unit (NICU). We aimed to analyse the effect of FICare on infant and parent outcomes, safety, and resource use. Methods: In this multicentre, cluster-randomised controlled trial, we stratified 26 tertiary NICUs from Canada, Australia, and New Zealand by country and size, and assigned them, using a computer-generated random allocation sequence, to provide FICare or standard NICU care. Eligible infants were born at 33 weeks' gestation or earlier, and had no or low-level respiratory support; parents gave written informed consent for enrolment. To be eligible, parents in the FICare group had to commit to be present for at least 6 h a day, attend educational sessions, and actively care for their infant. The primary outcome, analysed at the individual level, was infant weight gain at day 21 after enrolment. Secondary outcomes were weight gain velocity, high frequency breastfeeding (≥6 times a day) at hospital discharge, parental stress and anxiety at enrolment and day 21, NICU mortality and major neonatal morbidities, safety, and resource use (including duration of oxygen therapy and hospital stay). This trial is registered with ClinicalTrials.gov, number NCT01852695. Findings: From Oct 1, 2012, 26 sites were randomly assigned to provide FICare (n=14) or standard care (n=12). One site assigned to FICare discontinued because of poor site enrolment. Parents and infants were enrolled between April 1, 2013, and Aug 31, 2015, with 895 infants being eligible in the FICare group and 891 in the standard care group. At day 21, weight gain was greater in the FICare group than in the standard care group (mean change in Z scores -0·071 [SD 0·42] vs -0·155 [0·42]; p<0·0002). Average daily weight gain was significantly higher in infants receiving FICare than those receiving standard care (mean daily weight gain 26·7 g [SD 9·4] vs 24·8 g [9·5]; p<0·0001). The high-frequency exclusive breastmilk feeding rate at discharge was higher for infants in the FICare group (279 [70%] of 396) than those in the standard care group (394 [63%] of 624; p=0·016). At day 21, parents in the FICare group had lower mean stress scores than did parents in the standard care group (2·3 [SD 0·8] vs 2·5 [0·8]; p<0·00043), and lower mean anxiety scores (70·8 [20·1] vs 74·2 [19·9]; p=0·0045). There were no significant differences between groups in the rates of the secondary outcomes of mortality, major morbidity, duration of oxygen therapy, and duration of hospital stay. Although the safety assessment was not completed, there were no adverse events. Interpretation: FICare improved infant weight gain, decreased parent stress and anxiety, and increased high-frequency exclusive breastmilk feeding at discharge, which together suggest that FICare is an important advancement in neonatal care. Further research is required to examine if these results translate into better long-term outcomes for families. Funding: Canadian Institutes of Health Research Partnerships for Health System Improvement, and Ontario Ministry of Health and Long-Term Care.

The Lancet. Child & adolescent health · randomised controlled trial · 374 citationsread the source →

Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial.

Importance: Mindfulness-based stress reduction (MBSR) has not been rigorously evaluated for young and middle-aged adults with chronic low back pain. Objective: To evaluate the effectiveness for chronic low back pain of MBSR vs cognitive behavioral therapy (CBT) or usual care. Design, setting, and participants: Randomized, interviewer-blind, clinical trial in an integrated health care system in Washington State of 342 adults aged 20 to 70 years with chronic low back pain enrolled between September 2012 and April 2014 and randomly assigned to receive MBSR (n = 116), CBT (n = 113), or usual care (n = 113). Interventions: CBT (training to change pain-related thoughts and behaviors) and MBSR (training in mindfulness meditation and yoga) were delivered in 8 weekly 2-hour groups. Usual care included whatever care participants received. Main outcomes and measures: Coprimary outcomes were the percentages of participants with clinically meaningful (≥30%) improvement from baseline in functional limitations (modified Roland Disability Questionnaire [RDQ]; range, 0-23) and in self-reported back pain bothersomeness (scale, 0-10) at 26 weeks. Outcomes were also assessed at 4, 8, and 52 weeks. Results: There were 342 randomized participants, the mean (SD) [range] age was 49.3 (12.3) [20-70] years, 224 (65.7%) were women, mean duration of back pain was 7.3 years (range, 3 months-50 years), 123 (53.7%) attended 6 or more of the 8 sessions, 294 (86.0%) completed the study at 26 weeks, and 290 (84.8%) completed the study at 52 weeks. In intent-to-treat analyses at 26 weeks, the percentage of participants with clinically meaningful improvement on the RDQ was higher for those who received MBSR (60.5%) and CBT (57.7%) than for usual care (44.1%) (overall P = .04; relative risk [RR] for MBSR vs usual care, 1.37 [95% CI, 1.06-1.77]; RR for MBSR vs CBT, 0.95 [95% CI, 0.77-1.18]; and RR for CBT vs usual care, 1.31 [95% CI, 1.01-1.69]). The percentage of participants with clinically meaningful improvement in pain bothersomeness at 26 weeks was 43.6% in the MBSR group and 44.9% in the CBT group, vs 26.6% in the usual care group (overall P = .01; RR for MBSR vs usual care, 1.64 [95% CI, 1.15-2.34]; RR for MBSR vs CBT, 1.03 [95% CI, 0.78-1.36]; and RR for CBT vs usual care, 1.69 [95% CI, 1.18-2.41]). Findings for MBSR persisted with little change at 52 weeks for both primary outcomes. Conclusions and relevance: Among adults with chronic low back pain, treatment with MBSR or CBT, compared with usual care, resulted in greater improvement in back pain and functional limitations at 26 weeks, with no significant differences in outcomes between MBSR and CBT. These findings suggest that MBSR may be an effective treatment option for patients with chronic low back pain. Trial registration: clinicaltrials.gov Identifier: NCT01467843.

JAMA · randomised controlled trial · 469 citationsread the source →

Exercise training for advanced lung cancer.

Background: Patients with advanced lung cancer have a high symptom burden, which is often complicated by coexisting conditions. These issues, combined with the indirect effects of cancer treatment, can cumulatively lead patients to continued deconditioning and low exercise capacity. This is a concern as exercise capacity is considered a measure of whole body health, and is critical in a patient's ability to participate in life activities and tolerate difficult treatments. There is evidence that exercise training improves exercise capacity and other outcomes, such as muscle force and health-related quality of life (HRQoL), in cancer survivors. However, the effectiveness of exercise training on these outcomes in people with advanced lung cancer is currently unclear. Objectives: The primary aim of this review was to investigate the effects of exercise training on exercise capacity in adults with advanced lung cancer. Exercise capacity was defined as the six-minute walk distance (6MWD; in meters) measured during a six-minute walk test (6MWT; i.e. how far an individual can walk in six minutes on a flat course), or the peak oxygen uptake (i.e. VO₂peak) measured during a maximal incremental cardiopulmonary exercise test (CPET).The secondary aims were to determine the effects of exercise training on the force-generating capacity of peripheral muscles, disease-specific global HRQoL, physical functioning component of HRQoL, dyspnoea, fatigue, feelings of anxiety and depression, lung function, level of physical activity, adverse events, performance status, body weight and overall survival in adults with advanced lung cancer. Search methods: We searched CENTRAL, MEDLINE (via PubMed), Embase (via Ovid), CINAHL, SPORTDiscus, PEDro, and SciELO on 7 July 2018. Selection criteria: We included randomised controlled trials (RCTs) which compared exercise training versus no exercise training in adults with advanced lung cancer. Data collection and analysis: Two review authors independently screened the studies and selected those for inclusion. We performed meta-analyses for the following outcomes: exercise capacity, disease-specific global HRQoL, physical functioning HRQoL, dyspnoea, fatigue, feelings of anxiety and depression, and lung function (forced expiratory volume in one second (FEV1)). Two studies reported force-generating capacity of peripheral muscles, and we presented the results narratively. Limited data were available for level of physical activity, adverse events, performance status, body weight and overall survival. Main results: We identified six RCTs, involving 221 participants. The mean age of participants ranged from 59 to 70 years; the sample size ranged from 20 to 111 participants. Overall, we found that the risk of bias in the included studies was high, and the quality of evidence for all outcomes was low. Pooled data from four studies demonstrated that, on completion of the intervention period, exercise capacity (6MWD) was significantly higher in the intervention group than the control group (mean difference (MD) 63.33 m; 95% confidence interval (CI) 3.70 to 122.96). On completion of the intervention period, disease-specific global HRQoL was significantly better in the intervention group compared to the control group (standardised mean difference (SMD) 0.51; 95% CI 0.08 to 0.93). There was no significant difference between the intervention and control groups in physical functioning HRQoL (SMD 0.11; 95% CI -0.36 to 0.58), dyspnoea (SMD -0.27; 95% CI -0.64 to 0.10), fatigue (SMD 0.03; 95% CI -0.51 to 0.58), feelings of anxiety (MD -1.21 units on Hospital Anxiety and Depression Scale; 95% CI -5.88 to 3.45) and depression (SMD -1.26; 95% CI -4.68 to 2.17), and FEV1 (SMD 0.43; 95% CI -0.11 to 0.97). Authors' conclusions: Exercise training may improve or avoid the decline in exercise capacity and disease-specific global HRQoL for adults with advanced lung cancer. We found no significant effects of exercise training on dyspnoea, fatigue, feelings of anxiety and depression, or lung function. The findings of this review should be viewed with caution because of the heterogeneity between studies, the small sample sizes, and the high risk of bias of included studies. Larger, high-quality RCTs are needed to confirm and expand knowledge on the effects of exercise training in this population.

The Cochrane database of systematic reviews · meta-analysis · 83 citationsread the source →

A systematic review of assessment tools for adults used in traumatic brain injury research and their relationship to the ICF.

Background and aims: Good assessment is an essential component of effective patient management. Yet the sheer volume of available assessment instruments presents a barrier for the clinician or researcher to (a) be knowledgeable about suitable measures and (b) keep up-to-date with new measures that are published. In order to create a resource of currently-used measures, we conducted a systematic review of assessment tools used in the research literature on traumatic brain injury (TBI). Methods: We used two electronic databases (Medline and PsycINFO) to identify full-length, English-language articles published between 2000 and 2012 in which outcome in adults with TBI was assessed with behavioural tests or questionnaires. Results: The searches yielded 5,735 articles and after deletion of duplicates (n = 1,383) and articles not meeting selection criteria (n = 1,759), 2,593 articles were further examined. The articles contained 910 behavioural instruments, with a final set of 728 unique instruments. Each instrument was classified against the International Classification of Functioning, Disability and Health (ICF). Half of the instruments (n = 370, 50.8%) evaluated the mental functions domain of the ICF body functions component, with a substantially smaller proportion (n = 64, 8.8%) examining specific motor-sensory and other body functions. Instruments also covered domains of activities/participation (n = 109, 15.0%), environmental factors (n = 22, 3.0%) and personal factors (n = 36, 4.9%). A substantial number of scales (n = 93, 12.8%) were multidimensional across the body function domains (n = 32), as well as the functioning and disability part of the ICF (n = 60). The remaining 5% of instruments addressed concepts not covered by the ICF, including quality of life (n = 19, 2.6%) and rehabilitation process tools (such as therapeutic alliance). The 728 instruments were listed and more than 70 of the most common, spread across 20 domains, were highlighted. Conclusion: These data provide a comprehensive and up-to-date resource that gives the researcher or clinician a very large selection of assessment instruments covering the major areas of function pertinent to TBI.

NeuroRehabilitation · systematic review · 37 citationsread the source →

Treating Acute Insomnia: A Randomized Controlled Trial of a "Single-Shot" of Cognitive Behavioral Therapy for Insomnia.

Study objectives: Despite considerable evidence supporting cognitive behavioral therapy for insomnia (CBT-I) for chronic insomnia, it remains untested within the context of acute insomnia. This study examined the efficacy of a single session of CBT-I, with an accompanying self-help pamphlet, for individuals with acute insomnia. Design: A pragmatic parallel group randomized controlled trial. Setting: Community. Participants: Forty adults (mean age 32.9 ± 13.72 y) with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) defined insomnia disorder, except a self-reported duration of less than 3 mo (i.e., acute insomnia), who reported no previous exposure to CBT-I and were not currently taking medication for sleep. Interventions: A single 60- to 70-min session of CBT-I (n = 20), with an accompanying self-help pamphlet, or wait list control group (n = 20). All subjects were offered a full individual course of CBT-I on completion of the study, regardless of group allocation. Measurements and results: Subjects completed sleep diaries and the Insomnia Severity Index (ISI) pretreatment and 1 mo following treatment. There were no between-group differences on baseline ISI scores or subjective sleep continuity. The intervention group reported significantly lower ISI scores than controls (t(38) 2.24, P < 0.05) at follow-up. Further, using proposed ISI scores for identifying insomnia caseness (i.e., ≥ 10), 60% of those in the CBT-I group had remitted by 1 mo compared to 15% of those in the control group. Conclusions: This single session of cognitive behavioral therapy for insomnia (CBT-I) is sufficiently efficacious for a significant proportion of those with acute insomnia. The results are discussed in terms of integrating this brief form of CBT-I into the "stepped care" model of insomnia. Trial registration: Testing the efficacy of an early intervention for acute insomnia (SRCTN05891695) http://www.controlled-trials.com/ISRCTN05891695.

Sleep · randomised controlled trial · 91 citationsread the source →

The distribution of ''sense of coherence'' among Swedish adults: a quantitative cross-sectional population study.

Background: Antonovsky's concept of ''sense of coherence'' (SOC) has been shown to be related to health. The aim of this study was to describe the distribution of SOC scores and their components in an adult Swedish population aged 20-80 years. Methods: A random sample of 910 individuals from Jönköping, Sweden, aged 20, 30, 40, 50, 60, 70 and 80 years, of which 589 agreed to participate in an oral health examination. The participants answered Antonovsky's 13-item version of ''the life orientation questionnaire scale''. The response to the items and the distribution of the three components of comprehensibility, manageability and meaningfulness were analyzed for different age groups and genders using mean values and standard deviations, Student's t-test and ANOVA. Results: A total of 526 individuals, 263 men and 263 women, answered all 13 questions and constituted the final material for the study (response rate 89%). The individual SOC score increased with age. The 20 year olds had a statistically significantly lower SOC score compared with the other age groups and 55% of them had a low SOC (< or = 66 points) compared with 17% of the 80 year olds. Men in the 60 and 70 year age groups had a statistically significantly higher SOC score compared with women of the same age. Conclusions: The individual distribution of SOC varied with age and gender. Twenty year olds had a significantly lower SOC score compared with elderly age groups. Elderly men had a statistically significantly higher SOC score compared with women of the same age.

Scandinavian journal of public health · cohort or longitudinal · 60 citationsread the source →

Misdiagnosed patients with bipolar disorder: comorbidities, treatment patterns, and direct treatment costs.

Objective: The purpose of this study was to examine comorbidities, treatment patterns, and direct treatment costs of patients with bipolar disorder who are misdiagnosed with unipolar depression. Method: This study is a retrospective analysis of data from the MarketScan Commercial Claims and Encounters (CCE) database. Logistic regressions and analyses of variance were used to compare the misdiagnosis cohort to 3 age- and gender-matched comparison cohorts (recognized bipolar, depression, and no psychiatric disorders based on ICD-9-CM criteria) during the year 2000. Results: Each cohort had 769 individuals (68.0% female; mean age of roughly 42 years). The misdiagnosis cohort had higher rates of several psychiatric comorbidities than the depression cohort (e.g., personality disorders, alcohol abuse, psychotic disorder) and the bipolar cohort (e.g., generalized anxiety disorder, panic) but a lower rate of psychotic disorders than the bipolar cohort (p < .05). Compared with the bipolar cohort, the misdiagnosis cohort was more likely to receive antidepressants, but less likely to receive anticonvulsants, antipsychotics, or lithium (all p < .001). Antidepressant rates were similar among the misdiagnosis and depression cohorts. Group differences were found in mean annual costs for anticonvulsants, antipsychotics, lithium, antidepressants, and total treatment costs: bipolar (USD $442, $310, $67, $497, $8600); misdiagnosis (USD $221, $185, $20, $704, $8761); depression (USD $70, $74, $5, $657, $7288). Conclusion: Misdiagnosed bipolar patients received inappropriate and costly treatment regimens involving overuse of antidepressants and underuse of potentially effective medications. Patterns of psychiatric comorbidity suggest one possible strategy for improving recognition of bipolar disorder among patients presenting with depressive symptoms. Patients who present with the observed pattern of comorbidities may benefit from additional screening for bipolar disorder. It is recommended that steps be taken to minimize misdiagnosis in clinical settings.

The Journal of clinical psychiatry · cohort or longitudinal · 95 citationsread the source →

Late-onset hypogonadism: current concepts and controversies of pathogenesis, diagnosis and treatment.

Although suppressed serum testosterone (T) is common in ageing men, only a small proportion of them develop the genuine syndrome of low T associated with diffuse sexual (e.g., erectile dysfunction), physical (e.g. loss of vigor and frailty) and psychological (e.g., depression) symptoms. This syndrome carries many names, including male menopause or climacterium, andropause and partial androgen deficiency of the ageing male (PADAM). Late-onset hypogonadism (LOH) describes it best and is therefore generally preferred. The decrease of T in LOH is often marginal, and hypogonadism can be either due to primary testicular failure (low T, high luteinizing hormone (LH)) or secondary to a hypothalamic-pituitary failure (low T, low or inappropriately normal LH). The latter form is more common and it is usually associated with overweight/obesity or chronic diseases (e.g., type 2 diabetes mellitus, the metabolic syndrome, cardiovascular and chronic obstructive pulmonary disease, and frailty). A problem with the diagnosis of LOH is that often the symptoms (in 20%-40% of unselected men) and low circulating T (in 20% of men >70 years of age) do not coincide in the same individual. The European Male Ageing Study (EMAS) has recently defined the strict diagnostic criteria for LOH to include the simultaneous presence of reproducibly low serum T (total T <11 nmol l-1 and free T <220 pmol l-1 ) and three sexual symptoms (erectile dysfunction, and reduced frequency of sexual thoughts and morning erections). By these criteria, only 2% of 40- to 80-year-old men have LOH. In particular obesity, but also impaired general health, are more common causes of low T than chronological age per se. Evidence-based information whether, and how, LOH should be treated is sparse. The most logical approach is lifestyle modification, weight reduction and good treatment of comorbid diseases. T replacement is widely used for the treatment, but evidence-based information about its real benefi ts and short- and long-term risks, is not yet available. In this review, we will summarize the current concepts and controversies in the pathogenesis, diagnosis and treatment of LOH.

Asian journal of andrology · review · 124 citationsread the source →

A pilot randomized trial of metacognitive therapy vs applied relaxation in the treatment of adults with generalized anxiety disorder.

Metacognitive Therapy (MCT) and Applied Relaxation (AR) were compared in a pilot treatment trial of generalized anxiety disorder (GAD). Twenty outpatients meeting criteria for DSM-IV-TR GAD were assessed before treatment, after treatment and at 6 m and 12 m follow-up. The patients were randomized and treated individually for 8-12 weekly sessions. There was no drop-out from MCT and 10% at 6 m follow-up from AR. At post-treatment and at both follow-up points MCT was superior to AR. Standardized recovery rates for MCT at post-treatment were 80% on measures of worry and trait-anxiety compared with 10% following AR. At 6 m follow-up recovery rates for MCT were 70% on both measures compared with 10% and 20% for AR. At 12 m follow-up recovery rates for MCT were 80% (worry) and 60% (trait-anxiety) compared with 10% and 20% following AR. The recovery rates for MCT are similar to those obtained in an earlier uncontrolled trial (Wells & King, 2006). The effect sizes and standardized recovery rates for MCT suggest that it is a highly effective treatment.

Behaviour research and therapy · randomised controlled trial · 79 citationsread the source →

Effects of intermittent (5:2) or continuous energy restriction on basal and postprandial metabolism: a randomised study in normal-weight, young participants.

Background/objectives: Intermittent energy restriction (IER) may overcome poor long-term adherence with continuous energy restriction (CER), for weight reduction. We compared the effects of IER with CER for fasting and postprandial metabolism and appetite in metabolically healthy participants, in whom excess weight would not confound intrinsic metabolic differences. Subjects/methods: In a 2-week randomised, parallel trial, 16 young, healthy-weight participants were assigned to either CER (20% below estimated energy requirements (EER)) or 5:2 IER (70% below EER on 2 non-consecutive days; 5 days at EER, per week). Metabolic and appetite regulation markers were assessed before and for 3 h after a liquid breakfast; followed by an ad libitum lunch; pre- and post-intervention. Results: Weight loss was similar in both groups: -2.5 (95% CI, -3.4, -1.6) kg for 5:2 IER vs. -2.3 (-2.9, -1.7) kg for CER. There were no differences between groups for postprandial incremental area under the curve for serum insulin, blood glucose or subjective appetite ratings. Compared with CER, 5:2 IER led to a reduction in fasting blood glucose concentrations (treatment-by-time interaction, P = 0.018, η2p = 0.14). Similarly, compared with CER, there were beneficial changes in fasting composite appetite scores after 5:2 IER (treatment-by-time interaction, P = 0.0003, η2p = 0.35). Conclusions: There were no significant differences in postprandial insulinaemic, glycaemic or appetite responses between treatments. However, 5:2 IER resulted in greater improvements in fasting blood glucose, and beneficial changes in fasting subjective appetite ratings.

European journal of clinical nutrition · randomised controlled trial · 24 citationsread the source →

Patient and Cardiologist Perspectives on Shared Decision Making in the Treatment of Older Adults Hospitalized for Acute Myocardial Infarction.

Background. Medical and interventional therapies for older adults with acute myocardial infarction (AMI) reduce mortality and improve outcomes in selected patients, but there are also risks associated with treatments. Shared decision making (SDM) may be useful in the management of such patients, but to date, patients' and cardiologists' perspectives on SDM in the setting of AMI remain poorly understood. Accordingly, we performed a qualitative study eliciting patients' and cardiologists' perceptions of SDM in this scenario. Methods. We conducted 20 in-depth, semistructured interviews with older patients (age ≥70) post-AMI and 20 interviews with cardiologists. The interviews were transcribed and analyzed using ATLAS.ti. Two investigators independently coded transcripts using the constant comparative method, and an integrative, team-based process was used to identify themes. Results. Six major themes emerged: 1) patients felt their only choice was to undergo an invasive procedure; 2) patients placed a high level of trust and gratitude toward physicians; 3) patients wanted to be more informed about the procedures they underwent; 4) for cardiologists, patients' age was not a major contraindication to intervention, while cognitive impairment and functional limitation were; 5) while cardiologists intuitively understood the concept of SDM, interpretations varied; and 6) cardiologists considered SDM to be useful in the setting of non-ST elevated myocardial infarction (NSTEMI) but not ST-elevated myocardial infarction (STEMI). Conclusions. Patients viewed intervention as "the only choice," whereas cardiologists saw a need for balancing risks and benefits in treating older adults post-NSTEMI. This discrepancy implies there is room to improve communication of risks and benefits to older patients. A decision aid informed by the needs of older adults could help to better convey patient-specific risk and increase choice awareness.

Medical decision making : an international journal of the Society for Medical Decision Making · 10 citationsread the source →

Using RE-AIM metrics to evaluate diabetes self-management support interventions.

Background: Current healthcare evidence relies on relatively narrow efficacy data to make decisions about program impact. This paper illustrates the application of impact indices derived from the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework that takes a broader perspective and includes issues important to decision makers, such as reach, adoption, and cost. Methods: Composite RE-AIM indices that summarize impact and cost efficiency at the individual participant and setting levels are used to compare two different diabetes self-management support approaches. One study, the Diabetes Priority (DP) program, involved 886 diabetes patients from 30 primary care offices, and relied on usual clinical staff for program implementation. The other study, Diabetes Health Connection (DHC), involved 335 diabetes patients in both HMO and fee-for-service settings, and used health education staff. Results: The DP performed better on the setting-level impact index, but the programs produced similar results on individual-level impact. The DP had a greater reach (50% vs 38%); was more effective at the initial follow-up (median effect size [ES]=0.23 vs 0.17); and had greater impact consistency across various populations. The DHC performed better on several indices, including higher physician office adoption (20% vs 6%) and staff adoption (79% vs 70%), and there was less variability among intervention staff on protocol implementation (median ES=0.0 vs 0.50). Conclusions: Greater use of indices focused on public health and external validity criteria could help identify programs most likely to have a meaningful impact on population health and to fit local settings and priorities.

American journal of preventive medicine · cohort or longitudinal · 116 citationsread the source →

Explanatory models of health and disease among South Asian immigrants in Chicago.

To identify concepts of health and disease as part of a study on designing culturally-targeted heart disease prevention messages for South Asians. We conducted qualitative, semi-structured interviews in English, Hindi and Urdu with 75 respondents from a federally qualified health center and at a community center for South Asian immigrants in Chicago, Illinois. Age ranged from 20 to 70 years; 60% were women; 60% held advanced degrees; 70% migrated to the US in the last 10 years; and 60% of the interviews were in Hindi or Urdu. Concepts of health and disease fell into four domains: behavioral, physical, psycho-social and spiritual. Muslim participants consistently evoked spiritual factors such as faith and prayer. Women more frequently included performing home duties and positive affect in their concept of health. Men more frequently cited behavioral factors such as smoking and drinking as the cause of disease. Many South Asians have a holistic conceptualization of health and disease, incorporating spiritual, physical and psycho-social factors. Health promotion strategies aimed at South Asians in the US should take into account this holistic model of health and disease, while also recognizing that variations exist within South Asians, by gender and religion.

Journal of immigrant and minority health · 52 citationsread the source →

Disparities in Breastfeeding: Impact on Maternal and Child Health Outcomes and Costs.

Objective: To estimate the disease burden and associated costs attributable to suboptimal breastfeeding rates among non-Hispanic blacks (NHBs), Hispanics, and non-Hispanic whites (NHWs). Study design: Using current literature on associations between breastfeeding and health outcomes for 8 pediatric and 5 maternal diseases, we used Monte Carlo simulations to evaluate 2 hypothetical cohorts of US women followed from age 15 to 70 years and their infants followed from birth to age 20 years. Accounting for differences in parity, maternal age, and birth weights by race/ethnicity, we examined disease outcomes and costs using 2012 breastfeeding rates by race/ethnicity and outcomes that would be expected if 90% of infants were breastfed according to recommendations for exclusive and continued breastfeeding duration. Results: Suboptimal breastfeeding is associated with a greater burden of disease among NHB and Hispanic populations. Compared with a NHW population, a NHB population had 1.7 times the number of excess cases of acute otitis media attributable to suboptimal breastfeeding (95% CI 1.7-1.7), 3.3 times the number of excess cases of necrotizing enterocolitis (95% CI 2.9-3.7), and 2.2 times the number of excess child deaths (95% CI 1.6-2.8). Compared with a NHW population, a Hispanic population had 1.4 times the number of excess cases of gastrointestinal infection (95% CI 1.4-1.4) and 1.5 times the number of excess child deaths (95% CI 1.2-1.9). Conclusions: Racial/ethnic disparities in breastfeeding have important social, economic, and health implications, assuming a causal relationship between breastfeeding and health outcomes.

The Journal of pediatrics · cohort or longitudinal · 108 citationsread the source →

Innovations in animal health: artificial intelligence-enhanced hematocrit analysis for rapid anemia detection in small ruminants.

Due to their value as a food source, fiber, and other products globally, there has been a growing focus on the wellbeing and health of small ruminants, particularly in relation to anemia induced by blood-feeding gastrointestinal parasites like Haemonchus contortus. The objective of this study was to assess the packed cell volume (PCV) levels in blood samples from small ruminants, specifically goats, and create an efficient biosensor for more convenient, yet accurate detection of anemia for on-farm use in agricultural environments for animal production optimization. The study encompassed 75 adult male Spanish goats, which underwent PCV testing to ascertain their PCV ranges and their association with anemic conditions. Using artificial intelligence-powered machine learning algorithms, an advanced, easy-to-use sensor was developed for rapidly alerting farmers as to low red blood cell count of their animals in this way to enable timely medical intervention. The developed sensor utilizes a semi-invasive technique that requires only a small blood sample. More precisely, a volume of 30 μL of blood was placed onto Whatman filter paper No. 1, previously soaked with anhydrous glycerol. The blood dispersion pattern on the glycerol-infused paper was then recorded using a smartphone after 180 s. Subsequently, these images were examined in correlation with established PCV values obtained from conventional PCV analysis. Four separate machine learning models (ML) supported models, namely support vector machine (SVM), K-nearest neighbors (KNN), backpropagation neural network (BPNN), and image classification-based Keras model, were created and assessed using the image dataset. The dataset consisted of 1,054 images that were divided into training, testing, and validation sets in a 70:20:10 ratio. The initial findings indicated a detection accuracy of 76.06% after only 10 epochs for recognizing different levels of PCV in relation to anemia, ranging from healthy to severely anemic. This testing accuracy increased markedly, to 95.8% after 100 epochs and other model parameter optimization. Results for SVM had an overall F1 score of 74-100% in identifying the PCV range for blood pattern images representing healthy to severely anemic animals, and BPNN showed 91-100% accuracy in identifying the PCV range for anemia detection. This work demonstrates that AI-driven biosensors can be used for on-site rapid anemia detection. Optimized machine learning models maximize detection accuracy, proving the sensor's validity and rapidity in assessing anemia levels. This breakthrough will allow farmers, with rapid results, to increase animal wellbeing and agricultural productivity.

Frontiers in veterinary science · 4 citationsread the source →

Loneliness and Mental Health: The Mediating Effect of Perceived Social Support.

Social connectedness is a fundamental human need. The Evolutionary Theory of Loneliness (ETL) predicts that a lack of social connectedness has long-term mental and physical health consequences. Social support is a potential mechanism through which loneliness influences health. The present cross-sectional study examined the relationship between loneliness and mental health, and the mediating effects of social support in a Dutch adult sample (N = 187, age 20 to 70). The health variables included in the study are anxiety, depression, somatic symptoms as measured by the SCL-90, and the DSM-5 diagnosis somatic symptom disorder. The results indicated that social support partially mediated the relationship between loneliness and anxiety, depression, and somatic symptoms. These results indicate that social support partially explains the relationship between loneliness and physical and mental health issues. The relationship between loneliness and being diagnosed with somatic symptom disorder was not mediated by social support. This suggests that the mechanisms through which loneliness relates to either somatic symptoms or somatic symptom disorder are different.

International journal of environmental research and public health · 74 citationsread the source →

Is envy harmful to a society's psychological health and wellbeing? A longitudinal study of 18,000 adults.

Nearly 100 years ago, the philosopher and mathematician Bertrand Russell warned of the social dangers of widespread envy. One view of modern society is that it is systematically developing a set of institutions -- such as social media and new forms of advertising -- that make people feel inadequate and envious of others. If so, how might that be influencing the psychological health of our citizens? This paper reports the first large-scale longitudinal research into envy and its possible repercussions. The paper studies 18,000 randomly selected individuals over the years 2005, 2009, and 2013. Using measures of SF-36 mental health and psychological well-being, four main conclusions emerge. First, the young are especially susceptible. Levels of envy fall as people grow older. This longitudinal finding is consistent with a cross-sectional pattern noted recently by Nicole E. Henniger and Christine R. Harris, and with the theory of socioemotional regulation suggested by scholars such as Laura L. Carstensen. Second, using fixed-effects equations and prospective analysis, the analysis reveals that envy today is a powerful predictor of worse SF-36 mental health and well-being in the future. A change from the lowest to the highest level of envy, for example, is associated with a worsening of SF-36 mental health by approximately half a standard deviation (p < .001). Third, no evidence is found for the idea that envy acts as a useful motivator. Greater envy is associated with slower -- not higher -- growth of psychological well-being in the future. Nor is envy a predictor of later economic success. Fourth, the longitudinal decline of envy leaves unaltered a U-shaped age pattern of well-being from age 20 to age 70. These results are consistent with the idea that society should be concerned about institutions that stimulate large-scale envy.

Social science & medicine (1982) · 14 citationsread the source →

Gender differences in substance use and psychiatric distress among medical students: A comprehensive statewide evaluation.

Background: Medical student wellness has emerged as an important issue in medical education. The purpose of the present study was to obtain a comprehensive assessment of substance use, psychological distress, and help-seeking among male and female medical students in order to identify targets for continued intervention efforts. Methods: Medical students from all 9 medical schools in the state of Florida were invited via e-mail and/or announcements to complete an anonymous online questionnaire assessing their well-being. Of 5053 matriculating medical students, 1137 (57.1% female) responded to the questionnaire. Descriptive statistics, t tests, and chi-square analyses were computed using SPSS 20. Results: Over 70% of students acknowledged binge drinking, with men reporting higher frequency than women (χ2 = 13.90, P = .003), and 22.7% (n = 201) reported marijuana use during medical school, with higher rates (χ2 = 9.50, P = .02) among men (27.0%, n = 99) than women (18.9%, n = 93). A significant minority of students reported nonmedical use of prescription stimulants and prescription opioids. In addition, 3.3% of male students (n = 12) compared with 0.6% of female students (n = 3) reported problematic drug use. Further, almost 2/3 of respondents reported decreased psychological health since beginning medical school, with women noting greater reductions (χ2 = 12.39, P = .05) and higher levels of stress (χ2 = 16.30, P = .003). Over 10% of students (n = 102) endorsed "thoughts of committing suicide" during medical school, and 70.1% felt they would benefit from mental healthcare (79.3% of women vs. 59.6% of men; χ2 = 41.94, P < .001), although only 39.8% accessed help. Conclusions: Despite efforts to address medical student wellness, students continue to report concerning levels of psychological distress, suicidal ideation, and substance use. More work is needed to effectively address medical student mental health and well-being.

Substance abuse · 34 citationsread the source →

Cardiac rehabilitation using the Family-Centered Empowerment Model versus home-based cardiac rehabilitation in patients with myocardial infarction: a randomised controlled trial.

Objective: To determine if a hybrid cardiac rehabilitation (CR) programme using the Family-Centered Empowerment Model (FCEM) as compared with standard CR will improve patient quality of life, perceived stress and state anxiety of patients with myocardial infarction (MI). Methods: We conducted a randomised controlled trial in which patients received either standard home CR or CR using the FCEM strategy. Patient empowerment was measured with FCEM questionnaires preintervention and postintervention for a total of 9 assessments. Quality of life, perceived stress, and state and trait anxiety were assessed using the 36-Item Short Form Health Survey (SF-36), the 14-item Perceived Stress, and the 20-item State and 20-item Trait Anxiety questionnaires, respectively. Results: 70 patients were randomised. Baseline characteristics were similar. Ejection fraction was significantly higher in the intervention group at measurements 2 (p=0.01) and 3 (p=0.001). Exercise tolerance measured as walking distance was significantly improved in the intervention group throughout the study. The quality of life results in the FCEM group showed significant improvement both within the group over time (p<0.0001) and when compared with control (p<0.0001). Similarly, the perceived stress and state anxiety results showed significant improvement both within the FCEM group over time (p<0.0001) and when compared with control (p<0.0001). No significant difference was found either within or between groups for trait anxiety. Conclusions: The family-centred empowerment model may be an effective hybrid cardiac rehabilitation method for improving the physical and mental health of patients post-MI; however, further study is needed to validate these findings. Clinical Trials.gov identifier NCT02402582. Trial registration number: NCT02402582.

Open heart · 36 citationsread the source →

High Prevalence of Orthostatic Dysregulation among Circadian Rhythm Disorder Patients.

Study objectives: Patients with circadian rhythm sleep disorders (CRSDs) often have coincidence of orthostatic dysregulation (OD). Both disorders have many common clinical features. However, the prevalence of OD in patients with CRSD has not been examined. Methods: Thirty-eight patients with CRSD with either delayed sleep phase disorder or free-running disorder were tested for OD using the new orthostatic test, which was originally established by Tanaka et al. (< 20 years) and the Schellong test, i.e., the active standing test (≥ 20 years). Results: The overall prevalence of OD in patients with CRSD was 57.9% (22/38), and prevalence of OD was 70% in patients under 20 years of age (14/20). These rates exceed the previously reported values in adolescents aged 14-15 years (15%), regarded as the age with highest OD prevalence. Prevalence was not significantly associated with CRSD severity and medications used. Conclusions: We observed a high prevalence of OD in patients with CRSD, suggesting some relationship between CRSD and OD. Large-scale case-control studies are warranted to investigate the underlying mechanisms for this comorbidity.

Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 8 citationsread the source →

Anxiety, depression, trauma-related, and sleep disorders among healthcare workers during the COVID-19 pandemic: A systematic review and meta-analysis.

Healthcare workers have been facing the COVID-19 pandemic, with numerous critical patients and deaths, and high workloads. Quality of care is related to the mental status of healthcare workers. This PRISMA systematic review and meta-analysis, on Pubmed/Psycinfo up to October 8, 2020, estimates the prevalence of mental health problems among healthcare workers during this pandemic. The systematic review included 70 studies (101 017 participants) and only high-quality studies were included in the meta-analysis. The following pooled prevalences were estimated: 300 % of anxiety (95 %CI, 24.2-37.05); 311 % of depression (95 %CI, 25.7-36.8); 565 % of acute stress (95 %CI - 30.6-80.5); 20,2% of post-traumatic stress (95 %CI, 9.9-33.0); 44.0 % of sleep disorders (95 %CI, 24.6-64.5). The following factors were found to be sources of heterogeneity in subgroups and metaregressions analysis: proportion of female, nurses, and location. Targeted prevention and support strategies are needed now, and early in case of future health crises.

Neuroscience and biobehavioral reviews · meta-analysis · 336 citationsread the source →

Probiotics for the prevention of pediatric antibiotic-associated diarrhea.

Background: Antibiotics alter the microbial balance commonly resulting in antibiotic-associated diarrhea (AAD). Probiotics may prevent AAD via providing gut barrier, restoration of the gut microflora, and other potential mechanisms of action. Objectives: The primary objectives were to assess the efficacy and safety of probiotics (any specified strain or dose) used for the prevention of AAD in children. Search methods: MEDLINE, Embase, CENTRAL, CINAHL, and the Web of Science (inception to 28 May 2018) were searched along with registers including the ISRCTN and Clinicaltrials.gov. We also searched the NICE Evidence Services database as well as reference lists from relevant articles. Selection criteria: Randomized, parallel, controlled trials in children (0 to 18 years) receiving antibiotics, that compare probiotics to placebo, active alternative prophylaxis, or no treatment and measure the incidence of diarrhea secondary to antibiotic use were considered for inclusion. Data collection and analysis: Study selection, data extraction, and risk of bias assessment were conducted independently by two authors. Dichotomous data (incidence of AAD, adverse events) were combined using a pooled risk ratio (RR) or risk difference (RD), and continuous data (mean duration of diarrhea) as mean difference (MD), along with corresponding 95% confidence interval (95% CI). We calculated the number needed to treat for an additional beneficial outcome (NNTB) where appropriate. For studies reporting on microbiome characteristics using heterogeneous outcomes, we describe the results narratively. The certainty of the evidence was evaluated using GRADE. Main results: Thirty-three studies (6352 participants) were included. Probiotics assessed included Bacillus spp., Bifidobacterium spp., Clostridium butyricum, Lactobacilli spp., Lactococcus spp., Leuconostoc cremoris, Saccharomyces spp., orStreptococcus spp., alone or in combination. The risk of bias was determined to be high in 20 studies and low in 13 studies. Complete case (patients who did not complete the studies were not included in the analysis) results from 33 trials reporting on the incidence of diarrhea show a precise benefit from probiotics compared to active, placebo or no treatment control. After 5 days to 12 weeks of follow-up, the incidence of AAD in the probiotic group was 8% (259/3232) compared to 19% (598/3120) in the control group (RR 0.45, 95% CI 0.36 to 0.56; I² = 57%, 6352 participants; NNTB 9, 95% CI 7 to 13; moderate certainty evidence). Nineteen studies had loss to follow-up ranging from 1% to 46%. After making assumptions for those lost, the observed benefit was still statistically significant using an extreme plausible intention-to-treat (ITT) analysis, wherein the incidence of AAD in the probiotic group was 12% (436/3551) compared to 19% (664/3468) in the control group (7019 participants; RR 0.61; 95% CI 0.49 to 0.77; P <0.00001; I² = 70%). An a priori available case subgroup analysis exploring heterogeneity indicated that high dose (≥ 5 billion CFUs per day) is more effective than low probiotic dose (< 5 billion CFUs per day), interaction P value = 0.01. For the high dose studies the incidence of AAD in the probiotic group was 8% (162/2029) compared to 23% (462/2009) in the control group (4038 participants; RR 0.37; 95% CI 0.30 to 0.46; P = 0.06; moderate certainty evidence). For the low dose studies the incidence of AAD in the probiotic group was 8% (97/1155) compared to 13% (133/1059) in the control group (2214 participants; RR 0.68; 95% CI 0.46 to 1.01; P = 0.02). Again, assumptions for loss to follow-up using an extreme plausible ITT analysis was statistically significant. For high dose studies the incidence of AAD in the probiotic group was 13% (278/2218) compared to 23% (503/2207) in control group (4425 participants; RR 0.54; 95% CI 0.42 to 0.70; P <0.00001; I² = 68%; moderate certainty evidence).None of the 24 trials (4415 participants) that reported on adverse events reported any serious adverse events attributable to probiotics. Adverse event rates were low. After 5 days to 4 weeks follow-up, 4% (86/2229) of probiotics participants had an adverse event compared to 6% (121/2186) of control participants (RD 0.00; 95% CI -0.01 to 0.01; P < 0.00001; I² = 75%; low certainty evidence). Common adverse events included rash, nausea, gas, flatulence, abdominal bloating, and constipation. After 10 days to 12 weeks of follow-up, eight studies recorded data on our secondary outcome, the mean duration of diarrhea; with probiotics reducing diarrhea duration by almost one day (MD -0.91; 95% CI -1.38 to -0.44; P <0.00001; low certainty evidence). One study reported on microbiome characteristics, reporting no difference in changes with concurrent antibiotic and probiotic use. Authors' conclusions: The overall evidence suggests a moderate protective effect of probiotics for preventing AAD (NNTB 9, 95% CI 7 to 13). Using five criteria to evaluate the credibility of the subgroup analysis on probiotic dose, the results indicate the subgroup effect based on high dose probiotics (≥ 5 billion CFUs per day) was credible. Based on high-dose probiotics, the NNTB to prevent one case of diarrhea is 6 (95% CI 5 to 9). The overall certainty of the evidence for the primary endpoint, incidence of AAD based on high dose probiotics was moderate due to the minor issues with risk of bias and inconsistency related to a diversity of probiotic agents used. Evidence also suggests that probiotics may moderately reduce the duration of diarrhea, a reduction by almost one day. The benefit of high dose probiotics (e.g. Lactobacillus rhamnosus orSaccharomyces boulardii) needs to be confirmed by a large well-designed multi-centered randomized trial. It is premature to draw firm conclusions about the efficacy and safety of 'other' probiotic agents as an adjunct to antibiotics in children. Adverse event rates were low and no serious adverse events were attributable to probiotics. Although no serious adverse events were observed among inpatient and outpatient children, including small studies conducted in the intensive care unit and in the neonatal unit, observational studies not included in this review have reported serious adverse events in severely debilitated or immuno-compromised children with underlying risk factors including central venous catheter use and disorders associated with bacterial/fungal translocation.

The Cochrane database of systematic reviews · meta-analysis · 162 citationsread the source →

Omega-3 fatty acid addition during pregnancy.

Background: Higher intakes of foods containing omega-3 long-chain polyunsaturated fatty acids (LCPUFA), such as fish, during pregnancy have been associated with longer gestations and improved perinatal outcomes. This is an update of a review that was first published in 2006. Objectives: To assess the effects of omega-3 LCPUFA, as supplements or as dietary additions, during pregnancy on maternal, perinatal, and neonatal outcomes and longer-term outcomes for mother and child. Search methods: For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (16 August 2018), and reference lists of retrieved studies. Selection criteria: Randomised controlled trials (RCTs) comparing omega-3 fatty acids (as supplements or as foods, stand-alone interventions, or with a co-intervention) during pregnancy with placebo or no omega-3, and studies or study arms directly comparing omega-3 LCPUFA doses or types. Trials published in abstract form were eligible for inclusion. Data collection and analysis: Two review authors independently assessed study eligibility, extracted data, assessed risk of bias in trials and assessed quality of evidence for prespecified birth/infant, maternal, child/adult and health service outcomes using the GRADE approach. Main results: In this update, we included 70 RCTs (involving 19,927 women at low, mixed or high risk of poor pregnancy outcomes) which compared omega-3 LCPUFA interventions (supplements and food) compared with placebo or no omega-3. Overall study-level risk of bias was mixed, with selection and performance bias mostly at low risk, but there was high risk of attrition bias in some trials. Most trials were conducted in upper-middle or high-income countries; and nearly half the trials included women at increased/high risk for factors which might increase the risk of adverse maternal and birth outcomes. Preterm birth < 37 weeks (13.4% versus 11.9%; risk ratio (RR) 0.89, 95% confidence interval (CI) 0.81 to 0.97; 26 RCTs, 10,304 participants; high-quality evidence) and early preterm birth < 34 weeks (4.6% versus 2.7%; RR 0.58, 95% CI 0.44 to 0.77; 9 RCTs, 5204 participants; high-quality evidence) were both lower in women who received omega-3 LCPUFA compared with no omega-3. Prolonged gestation > 42 weeks was probably increased from 1.6% to 2.6% in women who received omega-3 LCPUFA compared with no omega-3 (RR 1.61 95% CI 1.11 to 2.33; 5141 participants; 6 RCTs; moderate-quality evidence).For infants, there was a possibly reduced risk of perinatal death (RR 0.75, 95% CI 0.54 to 1.03; 10 RCTs, 7416 participants; moderate-quality evidence: 62/3715 versus 83/3701 infants) and possibly fewer neonatal care admissions (RR 0.92, 95% CI 0.83 to 1.03; 9 RCTs, 6920 participants; moderate-quality evidence - 483/3475 infants versus 519/3445 infants). There was a reduced risk of low birthweight (LBW) babies (15.6% versus 14%; RR 0.90, 95% CI 0.82 to 0.99; 15 trials, 8449 participants; high-quality evidence); but a possible small increase in large-for-gestational age (LGA) babies (RR 1.15, 95% CI 0.97 to 1.36; 6 RCTs, 3722 participants; moderate-quality evidence, for omega-3 LCPUFA compared with no omega-3. Little or no difference in small-for-gestational age or intrauterine growth restriction (RR 1.01, 95% CI 0.90 to 1.13; 8 RCTs, 6907 participants; moderate-quality evidence) was seen. For the maternal outcomes, there is insufficient evidence to determine the effects of omega-3 on induction post-term (average RR 0.82, 95% CI 0.22 to 2.98; 3 trials, 2900 participants; low-quality evidence), maternal serious adverse events (RR 1.04, 95% CI 0.40 to 2.72; 2 trials, 2690 participants; low-quality evidence), maternal admission to intensive care (RR 0.56, 95% CI 0.12 to 2.63; 2 trials, 2458 participants; low-quality evidence), or postnatal depression (average RR 0.99, 95% CI 0.56 to 1.77; 2 trials, 2431 participants; low-quality evidence). Mean gestational length was greater in women who received omega-3 LCPUFA (mean difference (MD) 1.67 days, 95% CI 0.95 to 2.39; 41 trials, 12,517 participants; moderate-quality evidence), and pre-eclampsia may possibly be reduced with omega-3 LCPUFA (RR 0.84, 95% CI 0.69 to 1.01; 20 trials, 8306 participants; low-quality evidence).For the child/adult outcomes, very few differences between antenatal omega-3 LCPUFA supplementation and no omega-3 were observed in cognition, IQ, vision, other neurodevelopment and growth outcomes, language and behaviour (mostly low-quality to very low-quality evidence). The effect of omega-3 LCPUFA on body mass index at 19 years (MD 0, 95% CI -0.83 to 0.83; 1 trial, 243 participants; very low-quality evidence) was uncertain. No data were reported for development of diabetes in the children of study participants. Authors' conclusions: In the overall analysis, preterm birth < 37 weeks and early preterm birth < 34 weeks were reduced in women receiving omega-3 LCPUFA compared with no omega-3. There was a possibly reduced risk of perinatal death and of neonatal care admission, a reduced risk of LBW babies; and possibly a small increased risk of LGA babies with omega-3 LCPUFA.For our GRADE quality assessments, we assessed most of the important perinatal outcomes as high-quality (e.g. preterm birth) or moderate-quality evidence (e.g. perinatal death). For the other outcome domains (maternal, child/adult and health service outcomes) GRADE ratings ranged from moderate to very low, with over half rated as low. Reasons for downgrading across the domain were mostly due to design limitations and imprecision. Omega-3 LCPUFA supplementation during pregnancy is an effective strategy for reducing the incidence of preterm birth, although it probably increases the incidence of post-term pregnancies. More studies comparing omega-3 LCPUFA and placebo (to establish causality in relation to preterm birth) are not needed at this stage. A further 23 ongoing trials are still to report on over 5000 women, so no more RCTs are needed that compare omega-3 LCPUFA against placebo or no intervention. However, further follow-up of completed trials is needed to assess longer-term outcomes for mother and child, to improve understanding of metabolic, growth and neurodevelopment pathways in particular, and to establish if, and how, outcomes vary by different types of omega-3 LCPUFA, timing and doses; or by characteristics of women.

The Cochrane database of systematic reviews · meta-analysis · 254 citationsread the source →

Cognitive behavioural therapy for tinnitus.

Background: Tinnitus affects up to 21% of the adult population with an estimated 1% to 3% experiencing severe problems. Cognitive behavioural therapy (CBT) is a collection of psychological treatments based on the cognitive and behavioural traditions in psychology and often used to treat people suffering from tinnitus. Objectives: To assess the effects and safety of CBT for tinnitus in adults. Search methods: The Cochrane ENT Information Specialist searched the ENT Trials Register; CENTRAL (2019, Issue 11); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 25 November 2019. Selection criteria: Randomised controlled trials (RCTs) of CBT versus no intervention, audiological care, tinnitus retraining therapy or any other active treatment in adult participants with tinnitus. Data collection and analysis: We used the standard methodological procedures expected by Cochrane. Our primary outcomes were the impact of tinnitus on disease-specific quality of life and serious adverse effects. Our secondary outcomes were: depression, anxiety, general health-related quality of life, negatively biased interpretations of tinnitus and other adverse effects. We used GRADE to assess the certainty of evidence for each outcome. Main results: We included 28 studies (mostly from Europe) with a total of 2733 participants. All participants had had tinnitus for at least three months and their average age ranged from 43 to 70 years. The duration of the CBT ranged from 3 to 22 weeks and it was mostly conducted in hospitals or online. There were four comparisons and we were interested in outcomes at end of treatment, and 6 and 12 months follow-up. The results below only refer to outcomes at end of treatment due to an absence of evidence at the other follow-up time points. CBT versus no intervention/wait list control Fourteen studies compared CBT with no intervention/wait list control. For the primary outcome, CBT may reduce the impact of tinnitus on quality of life at treatment end (standardised mean difference (SMD) -0.56, 95% confidence interval (CI) -0.83 to -0.30; 10 studies; 537 participants; low certainty). Re-expressed as a score on the Tinnitus Handicap Inventory (THI; range 0 to 100) this is equivalent to a score 10.91 points lower in the CBT group, with an estimated minimal clinically important difference (MCID) for this scale being 7 points. Seven studies, rated as moderate certainty, either reported or informed us via personal communication about serious adverse effects. CBT probably results in little or no difference in adverse effects: six studies reported none and in one study one participant in the CBT condition worsened (risk ratio (RR) 3.00, 95% CI 0.13 to 69.87). For the secondary outcomes, CBT may result in a slight reduction in depression (SMD -0.34, 95% CI-0.60 to -0.08; 8 studies; 502 participants; low certainty). However, we are uncertain whether CBT reduces anxiety, improves health-related quality of life or reduces negatively biased interpretations of tinnitus (all very low certainty). From seven studies, no other adverse effects were reported (moderate certainty). CBT versus audiological care Three studies compared CBT with audiological care. CBT probably reduces the impact of tinnitus on quality of life when compared with audiological care as measured by the THI (range 0 to 100; mean difference (MD) -5.65, 95% CI -9.79 to -1.50; 3 studies; 444 participants) (moderate certainty; MCID = 7 points). No serious adverse effects occurred in the two included studies reporting these, thus risk ratios were not calculated (moderate certainty). The evidence suggests that CBT may slightly reduce depression but may result in little or no difference in anxiety or health-related quality of life (all low certainty) when compared with audiological care. CBT may reduce negatively biased interpretations of tinnitus when compared with audiological care (low certainty). No other adverse effects were reported for either group (moderate certainty). CBT versus tinnitus retraining therapy (TRT) One study compared CBT with TRT (including bilateral sound generators as per TRT protocol). CBT may reduce the impact of tinnitus on quality of life as measured by the THI when compared with TRT (range 0 to 100) (MD -15.79, 95% CI -27.91 to -3.67; 1 study; 42 participants; low certainty). For serious adverse effects three participants deteriorated during the study: one in the CBT (n = 22) and two in the TRT group (n = 20) (RR 0.45, 95% CI 0.04 to 4.64; low certainty). We are uncertain whether CBT reduces depression and anxiety or improves health-related quality of life (low certainty). CBT may reduce negatively biased interpretations of tinnitus. No data were available for other adverse effects. CBT versus other active control Sixteen studies compared CBT with another active control (e.g. relaxation, information, Internet-based discussion forums). CBT may reduce the impact of tinnitus on quality of life when compared with other active treatments (SMD -0.30, 95% CI -0.55 to -0.05; 12 studies; 966 participants; low certainty). Re-expressed as a THI score this is equivalent to 5.84 points lower in the CBT group than the other active control group (MCID = 7 points). One study reported that three participants deteriorated: one in the CBT and two in the information only group (RR 1.70, 95% CI 0.16 to 18.36; low certainty). CBT may reduce depression and anxiety (both low certainty). We are uncertain whether CBT improves health-related quality of life compared with other control. CBT probably reduces negatively biased interpretations of tinnitus compared with other treatments. No data were available for other adverse effects. Authors' conclusions: CBT may be effective in reducing the negative impact that tinnitus can have on quality of life. There is, however, an absence of evidence at 6 or 12 months follow-up. There is also some evidence that adverse effects may be rare in adults with tinnitus receiving CBT, but this could be further investigated. CBT for tinnitus may have small additional benefit in reducing symptoms of depression although uncertainty remains due to concerns about the quality of the evidence. Overall, there is limited evidence for CBT for tinnitus improving anxiety, health-related quality of life or negatively biased interpretations of tinnitus.

The Cochrane database of systematic reviews · meta-analysis · 131 citationsread the source →

Adverse childhood experiences and the association with ever using alcohol and initiating alcohol use during adolescence.

Purpose: Alcohol is the most common and frequently used drug and has the potential to cause multiple deleterious effects throughout the lifespan. Because early age at initiation of alcohol use increases this potential and programs and laws are in place to attempt to delay the onset of alcohol use, we studied the relationship between multiple adverse childhood experiences (ACEs) and both the likelihood of ever drinking and the age at initiating alcohol use. Methods: This was a retrospective cohort study of 8417 adult health maintenance organization (HMO) members in California who completed a survey about ACEs, which included childhood abuse and neglect, growing up with various forms of household dysfunction and alcohol use in adolescence and adulthood. The main outcomes measured were ever drinking and age at initiating alcohol use among ever-drinkers for four age categories: < or = 14 years (early adolescence), 15 to 17 years (mid adolescence), and 18 to 20 years (late adolescence); age > or = 21 years was the referent. The relationship between the total number of adverse childhood experiences (ACE score) and early initiation of alcohol use (< or =14 years) among four birth cohorts dating back to 1900 was also examined. Results: Eighty-nine percent of the cohort reported ever drinking; all individual ACEs except physical neglect increased the risk of ever using alcohol (p < .05). Among ever drinkers, initiating alcohol use by age 14 years was increased two- to threefold by individual ACEs (p < .05). ACEs also accounted for a 20% to 70% increased likelihood of alcohol use initiated during mid adolescence (15-17 years). The total number of ACEs (ACE score) had a very strong graded relationship to initiating alcohol use during early adolescence and a robust but somewhat less strong relationship to initiation during mid adolescence. For each of the four birth cohorts, the ACE score had a strong, graded relationship to initiating alcohol use by age 14 years (p < .05). Conclusions: Adverse childhood experiences are strongly related to ever drinking alcohol and to alcohol initiation in early and mid adolescence, and the ACE score had a graded or "dose-response" relationship to these alcohol use behaviors. The persistent graded relationship between the ACE score and initiation of alcohol use by age 14 for four successive birth cohorts dating back to 1900 suggests that the stressful effects of ACEs transcend secular changes, including the increased availability of alcohol, alcohol advertising, and the recent campaigns and health education programs to prevent alcohol use. These findings strongly suggest that efforts to delay the age of onset of drinking must recognize the contribution of multiple traumatic and stressful events to alcohol-seeking behavior among children and adolescents.

The Journal of adolescent health : official publication of the Society for Adolescent Medicine · 367 citationsread the source →

Populations and Interventions for Palliative and End-of-Life Care: A Systematic Review.

Importance: Evidence supports palliative care effectiveness. Given workforce constraints and the costs of new services, payers and providers need help to prioritize their investments. They need to know which patients to target, which personnel to hire, and which services best improve outcomes. Objective: To inform how payers and providers should identify patients with "advanced illness" and the specific interventions they should implement, we reviewed the evidence to identify (1) individuals appropriate for palliative care and (2) elements of health service interventions (personnel involved, use of multidisciplinary teams, and settings of care) effective in achieving better outcomes for patients, caregivers, and the healthcare system. Evidence review: Systematic searches of MEDLINE, EMBASE, PsycINFO, Web of Science, and Cochrane Database of Systematic Reviews databases (1/1/2001-1/8/2015). Results: Randomized controlled trials (124) met inclusion criteria. The majority of studies in cancer (49%, 38 of 77 studies) demonstrated statistically significant patient or caregiver outcomes (e.g., p < 0.05), as did those in congestive heart failure (CHF) (62%, 13 of 21), chronic obstructive pulmonary disease (COPD; 58%, 11 of 19), and dementia (60%, 15 of 25). Most prognostic criteria used clinicians' judgment (73%, 22 of 30). Most interventions included a nurse (70%, 69 of 98), and many were nurse-only (39%, 27 of 69). Social workers were well represented, and home-based approaches were common (56%, 70 of 124). Home interventions with visits were more effective than those without (64%, 28 of 44; vs. 46%, 12 of 26). Interventions improved communication and care planning (70%, 12 of 18), psychosocial health (36%, 12 of 33, for depressive symptoms; 41%, 9 of 22, for anxiety), and patient (40%, 8 of 20) and caregiver experiences (63%, 5 of 8). Many interventions reduced hospital use (65%, 11 of 17), but most other economic outcomes, including costs, were poorly characterized. Palliative care teams did not reliably lower healthcare costs (20%, 2 of 10). Conclusions: Palliative care improves cancer, CHF, COPD, and dementia outcomes. Effective models include nurses, social workers, and home-based components, and a focus on communication, psychosocial support, and the patient or caregiver experience. High-quality research on intervention costs and cost outcomes in palliative care is limited.

Journal of palliative medicine · systematic review · 135 citationsread the source →

Efficacy, efficiency and safety of a cardiac telerehabilitation programme using wearable sensors in patients with coronary heart disease: the TELEWEAR-CR study protocol.

Introduction: Exercise-based cardiac rehabilitation (CR) is a beneficial tool for the secondary prevention of cardiovascular diseases with, however, low participation rates. Telerehabilitation, intergrading mobile technologies and wireless sensors may advance the cardiac patients' adherence. This study will investigate the efficacy, efficiency, safety and cost-effectiveness of a telerehabilitation programme based on objective exercise telemonitoring and evaluation of cardiorespiratory fitness. Methods and analysis: A supervised, parallel-group, single-blind randomised controlled trial will be conducted. A total of 124 patients with coronary disease will be randomised in a 1:1 ratio into two groups: intervention telerehabilitation group (TELE-CR) (n=62) and control centre-based cardiac rehabilitation group (CB-CR) (n=62). Participants will receive a 12-week exercise-based rehabilitation programme, remotely monitored for the TELE-CR group and standard supervised for the CB-CR group. All participants will perform aerobic training at 70% of their maximal heart rate, as obtained from cardiopulmonary exercise testing (CPET) for 20 min plus 20 min for strengthening and balance training, three times per week. The primary outcomes will be the assessment of cardiorespiratory fitness, expressed as peak oxygen uptake assessed by the CPET test and the 6 min walk test. Secondary outcomes will be the physical activity, the safety of the exercise intervention (number of adverse events that may occur during the exercise), the quality of life, the training adherence, the anxiety and depression levels, the nicotine dependence and cost-effectiveness. Assessments will be held at baseline, end of intervention (12 weeks) and follow-up (36 weeks). Ethics and dissemination: The study protocol has been reviewed and approved by the Ethics Committee of the University of Thessaly (1108/1-12-2021) and by the Ethics Committee of the General University Hospital of Larissa (3780/31-01-2022). The results of this study will be disseminated through manuscript publications and conference presentations. Trial registration number: NCT05019157.

BMJ open · clinical trial · 26 citationsread the source →

Laparoscopic ileocaecal resection versus infliximab for terminal ileitis in Crohn's disease: a randomised controlled, open-label, multicentre trial.

Background: Treatment of patients with ileocaecal Crohn's disease who have not responded to conventional therapy is commonly scaled up to biological agents, but surgery can also offer excellent short-term and long-term results. We compared laparoscopic ileocaecal resection with infliximab to assess how they affect health-related quality of life. Methods: In this randomised controlled, open-label trial, in 29 teaching hospitals and tertiary care centres in the Netherlands and the UK, adults with non-stricturing, ileocaecal Crohn's disease, in whom conventional therapy has failed were randomly allocated (1:1) by an internet randomisation module with biased-coin minimisation for participating centres and perianal fistula to receive laparoscopic ileocaecal resection or infliximab. Eligible patients were aged 18-80 years, had active Crohn's disease of the terminal ileum, and had not responded to at least 3 months of conventional therapy with glucocorticosteroids, thiopurines, or methotrexate. Patients with diseased terminal ileum longer than 40 cm or abdominal abscesses were excluded. The primary outcome was quality of life on the Inflammatory Bowel Disease Questionnaire (IBDQ) at 12 months. Secondary outcomes were general quality of life, measured by the Short Form-36 (SF-36) health survey and its physical and mental component subscales, days unable to participate in social life, days on sick leave, morbidity (additional procedures and hospital admissions), and body image and cosmesis. Analyses of the primary outcome were done in the intention-to-treat population, and safety analyses were done in the per-protocol population. This trial is registered at the Dutch Trial Registry (NTR1150). Findings: Between May 2, 2008, and October 14, 2015, 73 patients were allocated to have resection and 70 to receive infliximab. Corrected for baseline differences, the mean IBDQ score at 12 months was 178·1 (95% CI 171·1-185·0) in the resection group versus 172·0 (164·3-179·6) in the infliximab group (mean difference 6·1 points, 95% CI -4·2 to 16·4; p=0·25). At 12 months, the mean SF-36 total score was 112·1 (95% CI 108·0-116·2) in the resection group versus 106·5 (102·1-110·9) in the infliximab group (mean difference 5·6, 95% CI -0·4 to 11·6), the mean physical component score was 47·7 (45·7-49·7) versus 44·6 (42·5-46·8; mean difference 3·1, 4·2 to 6·0), and the mean mental component score was 49·5 (47·0-52·1) versus 46·1 (43·3-48·9; mean difference 3·5, -0·3 to 7·3). Mean numbers of days of sick leave were 3·4 days (SD 7·1) in the resection group versus 1·4 days (4·7) in the infliximab group (p<0·0001), days not able to take part in social life were 1·8 days (6·3) versus 1·1 days (4·5; p=0·20), days of scheduled hospital admission were 6·5 days (3·8) versus 6·8 days (3·2; p=0·84), and the number of patients who had unscheduled hospital admissions were 13 (18%) of 73 versus 15 (21%) of 70 (p=0·68). Body-image scale mean scores in the patients who had resection were 16·0 (95% CI 15·2-16·8) at baseline versus 17·8 (17·1-18·4) at 12 months, and cosmetic scale mean scores were 17·6 (16·6-18·6) versus 18·6 (17·6-19·6). Surgical intervention-related complications classified as IIIa or worse on the Clavien-Dindo scale occurred in four patients in the resection group. Treatment-related serious adverse events occurred in two patients in the infliximab group. During a median follow-up of 4 years (IQR 2-6), 26 (37%) of 70 patients in the infliximab group had resection, and 19 (26%) of 73 patients in the resection group received anti-TNF. Interpretation: Laparoscopic resection in patients with limited (diseased terminal ileum <40 cm), non-stricturing, ileocaecal Crohn's disease in whom conventional therapy has failed could be considered a reasonable alternative to infliximab therapy. Funding: Netherlands Organisation for Health Research and Development.

The lancet. Gastroenterology & hepatology · randomised controlled trial · 228 citationsread the source →

The effect of expressive writing intervention for infertile couples: a randomized controlled trial.

Study question: Is expressive writing intervention (EWI) efficacious in reducing distress and improving pregnancy rates for couples going through ART treatment? Summary answer: Compared to controls, EWI statistically significantly reduced depressive symptoms but not anxiety and infertility-related distress. What is known already: ART treatment is considered stressful. So far, various psychological interventions have been tested for their potential in reducing infertility-related distress and the results are generally positive. It remains unclear whether EWI, a brief and potentially cost-effective intervention, could be advantageous. Study design size, duration: Between November 2010 and July 2012, a total of 295 participants (163 women, 132 men) were randomly allocated to EWI or a neutral writing control group. Participants/materials, setting, methods: Participants were couples undergoing IVF/ICSI treatment. Single women and couples with Preimplantation Genetic Diagnosis or acute change of procedure from insemination to IVF, were excluded. EWI participants participated in three 20-min home-based writing exercises focusing on emotional disclosure in relation to infertility/fertility treatment (two sessions) and benefit finding (one session). Controls wrote non-emotionally in three 20-min sessions about their daily activities. The participants completed questionnaires at the beginning of treatment (t1), prior to the pregnancy test (t2), and 3 months later (t3). In total, 26.8% (79/295) were lost to follow-up. Mixed linear models were chosen to compare the two groups over time for psychological outcomes (depression, anxiety and infertility-related distress), and a Chi2 test was employed in order to examine group differences in pregnancy rates MAIN RESULTS AND THE ROLE OF CHANCE: One hundred and fifty-three participants received EWI (women = 83; men = 70) and 142 participants were allocated to the neutral writing control group (women = 83; men = 62). Both women and partners in the EWI group exhibited greater reductions in depressive symptoms compared with controls (P = 0.049; [CI 95%: -0.04; -0.01] Cohen's d = 0.27). The effect of EWI on anxiety did not reach statistical significance. Overall infertility-related distress increased marginally for the partners in the EWI group compared to the partners in the control group (P = 0.06; Cohen's d = 0.17). However, in relation to the personal subdomain, the increase was statistically significant (P = 0.01; Cohen's d = 0.24). EWI had no statistically significant effect on pregnancy rates with 42/83 (50.6%) achieving pregnancy in the EWI group compared with 40/80 (49.4%) in the control group (RR = 0.99 [CI 95% = 0.725, 1.341]; P = 0.94). Limitations, reasons for caution: The results for depressive symptoms corresponded to a small effect size and the remaining results failed to reach statistical significance. This could be due to sample characteristics leading to a possible floor-effect, as we did not exclude participants with low levels of emotional distress at baseline. Furthermore, men showed increased infertility-related distress over time. Wider implications of the findings: EWI is a potentially cost-effective and easy to implement home-based intervention, and even small effects may be relevant. When faced with infertility, EWI could thus be a relevant tool for alleviating depressive symptoms by allowing the expression of feelings about infertility that may be perceived as socially unacceptable. However, the implications do not seem to be applicable for men, who presented with increased infertility-related distress over time. Study funding/competing interests: The present study was supported by research grants from Merck Sharpe and Dohme and The Danish Agency for Science Technology and Innovation as part of a publicly funded PhD. The funding bodies had no influence on the data collection, analysis or conclusions of the study. None of the authors have any conflicts of interest to declare. Trial registration number: Clinicaltrials.gov, trial no. NCT01187095. Trial registration date: 7th September 2010 DATE OF FIRST PATIENT'S ENROLMENT: 23rd November 2010.

Human reproduction (Oxford, England) · randomised controlled trial · 36 citationsread the source →

Online positive-oriented counseling, taking vitamin D3 tablet, online lifestyle modification training on premenstrual syndrome: a 3-armed randomized clinical trial.

Lack of absolute treatment for premenstrual syndrome (PMS), its cyclic nature, considerable prevalence (70-90%), and its mental and physical burden imply necessity of effectiveness comparison of various treatments. Although antidepressant and hormonal drugs are well-known medications for PMS, in affected women who can't tolerate, or don't have compatibility or compliance with these drugs, other effective treatments have always been important concern. This study aimed to compare effectiveness of online positive-oriented counseling, taking vitamin D3 tablet, and online lifestyle modification training on alleviating PMS. 3-armed parallel randomized clinical trial was performed on 84 20-40-year-old eligible women with PMS. 84 women were randomly ( www.random.org/sequenc ) allocated into three groups, but data of 77 women (1, n = 25) online positive-oriented counseling group (6 sessions), (2, n = 27) vitamin D3 tablet group (one vitamin D3 tablet weekly for 6 weeks), and (3, n = 25) online lifestyle training group (6 sessions) were analyzed. Vitamin D3 was measured at baseline, week6 and fallow up week10. Primary outcome variable PMS was measured with Premenstrual Symptoms Screening Tool (PSST) at baseline, week 6, and follow-up week 10. Primary outcome satisfaction with intervention method was measured using satisfaction scale at week 6 and follow-up week 10. ANOVA, Repeated Measures, and Paired samples t-test were used for statistical analysis. There was no statistically significant difference in PMS at baseline between three groups respectively (33 ± 5.8, 34.1 ± 7.1, & 35.2 ± 6.4, P = 0.500). However, at follow-up week 10, there was statistically significant difference between three groups (22.3 ± 4.3, 25.4 ± 6.5, & 31.8 ± 6.5; P < 0.001), with greatest improvement in online positive-oriented counseling group (P < 0.001). Satisfaction differed significantly among three groups at week 6 (51 ± 6.8, 46.4 ± 12, & 42.3 ± 6.3, P = 0.001) and follow-up week 10 (55.7 ± 11.6, 51.4 ± 12; & 43 ± 3.3, P < 0.001), with most satisfaction in positive-oriented counseling group (P < 0.001). All three interventions alleviated PMS, but online positive-oriented counseling was more effective and satisfying. Superiority of positive-oriented counseling implies mechanism of adaptation, better relationships, forgiveness, self-mood-regulation, and feasibility of its skills that could be continued individually by women after counseling completion. It is recommended health providers, health policymakers and managers support use of these interventions in treatment program and clinical guidelines. Trial registration: RCT registration number: IRCT20191231045967N1, Registration date:11/02/2020, Registration timing: prospective (IRCT | Survey the effect of vitamin D3 tablet intake, positivism group consulting with changing in life style in the treatment of premenstrual syndrome in women).

Scientific reports · randomised controlled trial · 4 citationsread the source →

A randomized clinical trial of the effectiveness of a Web-based health behaviour change support system and group lifestyle counselling on body weight loss in overweight and obese subjects: 2-year outcomes.

Background: Weight loss can prevent and treat obesity-related diseases. However, lost weight is usually regained, returning to the initial or even higher levels in the long term. New counselling methods for maintaining lifestyle changes are urgently needed. Objectives: An information and communication technology-based health behaviour change support system (HBCSS) that utilizes persuasive design and methods of cognitive behavioural therapy (CBT) was developed with the aim of helping individuals to maintain body weight. The purpose of this study was to assess whether CBT-based group counselling combined with HBCSS or HBCSS alone helps to maintain improved lifestyle changes needed for weight loss compared to self-help guidance or usual care. Methods: A randomized lifestyle intervention for overweight or obese persons (BMI 27-35 kg m-2 and age 20-60 years), recruited from the population registry in the city of Oulu, Finland, was conducted. This study comprised six randomly assigned study arms: CBT-based group counselling (eight sessions led by a nutritionist), self-help guidance-based group counselling (SHG; two sessions led by a nurse) and control, each with or without HCBSS, for 52 weeks. Subjects visited the study centre for anthropometric measurements, blood sample collection and to complete questionnaires at baseline, 12 and 24 months. The main outcome was weight change from baseline to 12 months and from baseline to 24 months. Results: Of the 1065 volunteers screened for the study, 532 subjects (51% men) met the inclusion criteria and were enrolled. The retention rate was 80% at 12 months and 70% at 24 months. CBT-based counselling with HBCSS produced the largest weight reduction without any significant weight gain during follow-up. The mean weight change in this arm was 4.1% [95% confidence interval (CI), -5.4 to -2.8, P < 0.001) at 12 months and 3.4% (95% CI, -4.8 to -2.0, P < 0.001) at 24 months. HBCSS even without any group counselling reduced the mean weight by 1.6% (95% CI, -2.9 to -0.3, P = 0.015) at 24 months. Conclusion: The combination of CBT-based group counselling and HBCSS-based weight management is feasible for overweight or obese individuals. Moreover, HBCSS alone could be disseminated to the population at large as an effective means of treating obesity.

Journal of internal medicine · randomised controlled trial · 43 citationsread the source →

A task-shared, collaborative care psychosocial intervention for improving depressive symptomatology among older adults in a socioeconomically deprived area of Brazil (PROACTIVE): a pragmatic, two-arm, parallel-group, cluster-randomised controlled trial.

Background: There is an urgent need to reduce the burden of depression among older adults in low-income and middle-income countries (LMICs). We aimed to evaluate the efficacy of a task-shared, collaborative care psychosocial intervention for improving recovery from depression in older adults in Brazil. Methods: PROACTIVE was a pragmatic, two-arm, parallel-group, cluster-randomised controlled trial conducted in Guarulhos, Brazil. Primary care clinics (clusters) were stratified by educational level and randomly allocated (1:1) to either enhanced usual care alone (control group) or to enhanced usual care plus the psychosocial intervention (intervention group), which involved a 17-week psychosocial programme based on psychoeducation and behavioural activation approaches. Individuals approached for the initial screening assessment were selected randomly from a list of individuals provided by the Health Secretariat of Guarulhos. Face-to-face baseline assessments were conducted among adults aged 60 years or older registered with one of the primary care clinics and identified with clinically significant depressive symptomatology (9-item Patient Health Questionnaire [PHQ-9] score ≥10). Community health workers delivered the programme through home sessions, supported by a dedicated tablet application. Masking of clinic staff and community health workers who delivered the intervention was not feasible; however, research assistants conducting recruitment and follow-up assessments were masked to trial allocation. The primary outcome was recovery from depression (PHQ-9 score <10) at 8-month follow-up. All primary analyses were performed by intention to treat with imputed data. Adaptations to the protocol were made due to the COVID-19 pandemic; recruitment and intervention home sessions were stopped, and follow-up assessments were conducted by telephone. This trial is registered with the ISRCTN registry, ISRCTN57805470. Findings: We identified 24 primary care clinics in Guarulhos that were willing to participate, of which 20 were randomly allocated to either the control group (ten [50%] clusters) or to the intervention group (ten [50%] clusters). The four remaining eligible clusters were kept as reserves. Between May 23, 2019, and Feb 21, 2020, 8146 individuals were assessed for eligibility, of whom 715 (8·8%) participants were recruited: 355 (49·7%) in the control group and 360 (50·3%) in the intervention group. 284 (80·0%) participants in the control group and 253 (70·3%) in the intervention group completed follow-up at 8 months. At 8-month follow-up, 158 (62·5%) participants in the intervention group showed recovery from depression (PHQ-9 score <10) compared with 125 (44·0%) in the control group (adjusted odds ratio 2·16 [95% CI 1·47-3·18]; p<0·0001). These findings were maintained in the complete case analysis. No adverse events related to the intervention were observed. Interpretation: Although the COVID-19 pandemic altered delivery of the intervention, the low-intensity psychosocial intervention delivered mainly by non-mental health professionals was highly efficacious in improving recovery from depression in older adults in Brazil. Our results support a low-resource intervention that could be useful to reduce the treatment gap for depression among older people in other LMICs. Funding: São Paulo Research Foundation and Joint Global Health Trials (UK Department for International Development, Medical Research Council, and the Wellcome Trust).

The lancet. Healthy longevity · randomised controlled trial · 25 citationsread the source →

The effects of volunteering on loneliness among lonely older adults: the HEAL-HOA dual randomised controlled trial.

Background: Previous randomised controlled trials have largely relied on self-reported volunteer work to assess the effects of volunteering and have rarely provided structured volunteering activities during the intervention period. The present study aimed to investigate the effects of social volunteering work over 12 months on loneliness among older adults during the COVID-19 pandemic. Methods: A dual randomised controlled trial was done in Hong Kong to investigate the long-term effects of telephone-delivered psychosocial interventions by older Chinese volunteers who were screened as lonely, for older adult recipients who had low income, lived alone, felt lonely, and were digitally excluded. Participants were included if they were aged 50-70 years; had provided consent to be trained and serve as a volunteer for at least 2 h per week for 6 months; had at least 3 years of secondary school education; had no severe self-reported physical, mental, or cognitive health problems; were not working full or part-time; had engaged in formal volunteering fewer than four times within the past year; and were lonely (ie, had a score of at least 6 on the three-item UCLA Loneliness Scale). Participants were allocated into either the volunteering or control group (psychoeducation programme) using a random number method. The details of group allocation were concealed as the research assistant responsible for randomisation was different to the research assistants responsible for recruitment and assessments (who were masked to the condition). Following a 6-week training, the volunteers delivered a psychosocial intervention to older intervention recipients for 6 months. The primary outcome was loneliness measured with the 20-item UCLA Loneliness Scale and the De Jong Gierveld (DJG) Loneliness Scales at 6 months and 12 months. Assessments were performed before training (baseline; T1), at 6 months (T2), and at 12 months after training (T3). The intention-to-treat principle was used to compare the effects of volunteering between the two groups. The trial was registered in the Clinical Trials Registry of the University of Hong Kong Clinical Trials Centre (HKUCTR-2929). This trial has completed. Findings: Between May 3, 2021, and Oct 6, 2022, a total of 375 individuals were recruited to the trial, including 84 males (22%) and 291 females (78%). 185 were randomly assigned to the volunteering group (56 to deliver a mindfulness intervention, 65 to deliver a behavioural activation intervention, and 64 to deliver a befriending intervention) and 190 were assigned to the control group. 311 (83%) of 375 participants were 60 years or older (median 64 years [SD 4·86]). Participants in the volunteering group reported a significantly lower level of loneliness at T2 (dppc2 ranged from -0·41 to -0·70) compared with T1 than participants in the control condition. There was a significant decrease in loneliness measured using the UCLA Loneliness Scale at T2 in the volunteering group but such a decline was not shown in the control group (condition × time interaction, estimate 0·19 [95% CI 0·08 to 0·29], p=0·00058, dppc2=-0·41). Similarly, when measured with the DJG Loneliness Scale, there was a significantly greater decrease in loneliness in the volunteering group compared with the control group at T2, including a medium to large effect size on total DJG scores (estimate 1·34 [95% CI 0·83 to 1·84], p<0·0001, dppc2=-0·70) and a medium effect size on emotional (estimate 0·63 [0·35 to 0·90], p<0·0001, dppc2=-0·59) and social subscales (estimate 0·71 [95% CI 0·37 to 1·05], p<0·0001, dppc2=-0·58). Although most of the positive effects of volunteering were not sustained at T3, the volunteers who continued to volunteer for more than 2 h per week at T3 reported lower levels of loneliness than those who did not maintain volunteering. Interpretation: This randomised controlled trial demonstrates the beneficial effect of volunteering on reducing loneliness in older adults who feel lonely, and that this benefit can be maintained through continued participation in voluntary work. Future intervention programmes should strengthen older adults' commitment to volunteer. Funding: Research Grants Committee of the Hong Kong Special Administrative Region, China.

The lancet. Healthy longevity · randomised controlled trial · 16 citationsread the source →

Telehealth Home Monitoring and Postcardiac Surgery for Congenital Heart Disease.

Objectives: To test the effect of a 4-month telehealth home monitoring program (REACH), layered on usual care, on postdischarge outcomes in parents of infants recovering from cardiac surgery and their infants. Methods: Randomized trial of infants discharged from the hospital after cardiac surgery for congenital heart disease. Consecutive infants with complex congenital heart disease undergoing cardiac surgery within 21 days of life were enrolled at 3 university-affiliated pediatric cardiac centers. Results: From 2012 to 2016, 219 parent-infant dyads were enrolled; 109 were randomly assigned to the intervention group and 110 to the control group. At 4 months postdischarge, parenting stress was not significantly different between groups (total Parenting Stress Index in the intervention group was 220 and in the control group was 215; P = .61). The percentages of parents who met posttraumatic stress disorder (PTSD) criteria and parent quality of life inventory scores were also not significantly different between the 2 groups (PTSD in the intervention group was 18% and was 18% in the control group; P =.56; the mean Ulm Quality of Life Inventory for Parents in the intervention group was 71 andwas 70 in the control group; P = .88). Infant growth in both groups was suboptimal (the mean weight-for-age z scores were -1.1 in the intervention group and -1.2 in the control group; P = .56), and more infants in the intervention group were readmitted to the hospital (66% in the intervention group versus 57% in the control group; P < .001). Conclusions: When added to usual care, the REACH intervention was not associated with an improvement in parent or infant outcomes. Four months after neonatal heart surgery, ∼20% of parents demonstrate PTSD symptoms. Suboptimal infant growth and hospital readmissions were common.

Pediatrics · randomised controlled trial · 26 citationsread the source →

Feasibility and efficacy of a digital CBT intervention for symptoms of Generalized Anxiety Disorder: A randomized multiple-baseline study.

Background and objectives: Cognitive behavioral therapy (CBT) is a first-line treatment for anxiety, but it is not widely available as clinical guidelines recommend. We examined the feasibility and efficacy of a novel smartphone-based fully automated digital CBT intervention, 'Daylight™', to improve symptoms of Generalized Anxiety Disorder (GAD). Methods: In this multiple-baseline design, 21 adults (20 F; mean age 43yrs. range 19-65yrs.) with moderate-to-severe symptoms of GAD were randomized to one of three baseline durations (2-, 4-, or 6-weeks) and then received access to digital CBT. Participants completed daily ratings of anxiety and worry, weekly measures of anxiety, depressive symptoms, and sleep, and measures of anxiety, worry, wellbeing, quality of life, CBT skill acquisition, and work performance at initial assessment prior to baseline randomization, post-intervention, and follow-up. Results: Digital CBT was found to be feasible in terms of engagement, satisfaction, and safety. For preliminary efficacy, improvements were detected in daily and weekly outcomes of anxiety for most participants. Despite individual differences, significant improvements occurred with the introduction of digital CBT and not during baseline. Overall, 70% of participants no longer had clinically significant symptoms of GAD, 61% no longer had significant depressive symptoms, and 40% no longer had significant sleep difficulty at post-intervention. Limitations: The study sample was recruited using the internet and was mostly female, limiting the generalizability of the findings. Conclusions: Findings support the feasibility and efficacy of Daylight. Further examination in randomized controlled trials is now warranted.

Journal of behavior therapy and experimental psychiatry · randomised controlled trial · 24 citationsread the source →

Sense of coherence and its relationship with oral health-related behaviour and knowledge of and attitudes towards oral health.

Objective: To investigate the relationship between sense of coherence (SOC), oral health-related behaviour, knowledge of and attitudes towards oral health in an adult Swedish population. Methods: A cross-sectional design with a stratified random sample of 910 individuals aged 20, 30, 40, 50, 60, 70 and 80 years were invited to the study, from Jönköping, Sweden. The investigation used the Swedish short version of the SOC questionnaire comprising 13 items and self-reported questions about oral health habits and knowledge of and attitudes towards oral health. In addition, a self-report questionnaire to elicit demographic information was included. Results: A total of 525 individuals, 261 men and 264 women, answered all the 13-item SOC questions, which constituted the final number of the participants. After adjustment for all the sociodemographic factors included in the analysis, individuals with a stronger SOC had twice as high a chance of having healthier behaviour, including a lower frequency of snacks and drinks between meals, as well as a more positive attitude, such as the importance of having one's own teeth as one gets older, satisfaction with their own teeth, perceiving their teeth as good and no feeling of dental fear, compared with individuals with a poorer SOC. Moreover, SOC and a good knowledge of caries were significantly associated after adjustment for age and gender. Conclusions: SOC was significantly associated with several oral health-related behaviours, attitudes towards oral health and knowledge of dental caries. When working with oral health promotion, SOC could be a way for promoting a better understanding of the behaviour and attitudes of individuals and for enabling dental personals to use that knowledge for the guidance of the individual.

Community dentistry and oral epidemiology · 45 citationsread the source →

A randomized controlled trial of psychoanalytic psychotherapy or cognitive-behavioral therapy for bulimia nervosa.

Objective: The authors compared psychoanalytic psychotherapy and cognitive-behavioral therapy (CBT) in the treatment of bulimia nervosa. Method: A randomized controlled trial was conducted in which 70 patients with bulimia nervosa received either 2 years of weekly psychoanalytic psychotherapy or 20 sessions of CBT over 5 months. The main outcome measure was the Eating Disorder Examination interview, which was administered blind to treatment condition at baseline, after 5 months, and after 2 years. The primary outcome analyses were conducted using logistic regression analysis. Results: Both treatments resulted in improvement, but a marked difference was observed between CBT and psychoanalytic psychotherapy. After 5 months, 42% of patients in CBT (N=36) and 6% of patients in psychoanalytic psychotherapy (N=34) had stopped binge eating and purging (odds ratio=13.40, 95% confidence interval [CI]=2.45-73.42; p<0.01). At 2 years, 44% in the CBT group and 15% in the psychoanalytic psychotherapy group had stopped binge eating and purging (odds ratio=4.34, 95% CI=1.33-14.21; p=0.02). By the end of both treatments, substantial improvements in eating disorder features and general psychopathology were observed, but in general these changes took place more rapidly in CBT. Conclusions: Despite the marked disparity in the number of treatment sessions and the duration of treatment, CBT was more effective in relieving binging and purging than psychoanalytic psychotherapy and was generally faster in alleviating eating disorder features and general psychopathology. The findings indicate the need to develop and test a more structured and symptom-focused version of psychoanalytic psychotherapy for bulimia nervosa.

The American journal of psychiatry · randomised controlled trial · 126 citationsread the source →

Health of men, women, and children in post-trafficking services in Cambodia, Thailand, and Vietnam: an observational cross-sectional study.

Background: Trafficking is a crime of global proportions involving extreme forms of exploitation and abuse. Yet little research has been done of the health risks and morbidity patterns for men, women, and children trafficked for various forms of forced labour. Methods: We carried out face-to-face interviews with a consecutive sample of individuals entering 15 post-trafficking services in Cambodia, Thailand, and Vietnam. We asked participants about living and working conditions, experience of violence, and health outcomes. We measured symptoms of anxiety and depression with the Hopkins Symptoms Checklist and post-traumatic stress disorder with the Harvard Trauma Questionnaire, and used adjusted logistic regression models to estimate the effect of trafficking on these mental health outcomes, controlling for age, sector of exploitation, and time in trafficking. Findings: We interviewed 1102 people, of whom 1015 reached work destinations. Participants worked in various sectors including sex work (329 [32%]), fishing (275 [27%]), and factories (136 [13%]). 481 (48%) of 1015 experienced physical violence, sexual violence, or both, with 198 (35%) of 566 women and girls reporting sexual violence. 478 (47%) of 1015 participants were threatened and 198 (20%) were locked in a room. 685 (70%) of 985 who had data available worked 7 days per week and 296 (30%) of 989 worked at least 11 hours per day. 222 (22%) of 983 had a serious injury at work. 61·2% (95% CI 58·2-64·2) of participants reported symptom of depression, 42·8% (39·8-45·9) reported symptoms of anxiety, and 38·9% (36·0-42·0) reported symptoms of post-traumatic stress disorder. 5·2% (4·0-6·8) had attempted suicide in the past month. Participants who experienced extremely excessive overtime at work, restricted freedom, bad living conditions, threats, or severe violence were more likely to report symptoms of depression, anxiety, and post-traumatic stress disorder. Interpretation: This is the first health study of a large and diverse sample of men, women, and child survivors of trafficking for various forms of exploitation. Violence and unsafe working conditions were common and psychological morbidity was associated with severity of abuse. Survivors of trafficking need access to health care, especially mental health care. Funding: Anesvad Foundation and International Organization for Migration International Development Fund.

The Lancet. Global health · 87 citationsread the source →

Are workplace health promotion programs effective at improving presenteeism in workers? A systematic review and best evidence synthesis of the literature.

Background: Presenteeism is highly prevalent and costly to employers. It is defined as being present at work, but limited in some aspect of job performance by a health problem. Workplace health promotion (WHP) is a common strategy used to enhance on-the-job productivity. The primary objective is to determine if WHP programs are effective in improving presenteeism. The secondary objectives are to identify characteristics of successful programs and potential risk factors for presenteeism. Methods: The Cochrane Library, Medline, and other electronic databases were searched from 1990 to 2010. Reference lists were examined, key journals were hand-searched and experts were contacted. Included studies were original research that contained data on at least 20 participants (≥ 18 years of age), and examined the impacts of WHP programs implemented at the workplace. The Effective Public Health Practice Project Tool for Quantitative Studies was used to rate studies. 'Strong' and 'moderate' studies were abstracted into evidence tables, and a best evidence synthesis was performed. Interventions were deemed successful if they improved the outcome of interest. Their program components were identified, as were possible risk factors contributing to presenteeism. Results: After 2,032 titles and abstracts were screened, 47 articles were reviewed, and 14 were accepted (4 strong and 10 moderate studies). These studies contained preliminary evidence for a positive effect of some WHP programs. Successful programs offered organizational leadership, health risk screening, individually tailored programs, and a supportive workplace culture. Potential risk factors contributing to presenteeism included being overweight, a poor diet, a lack of exercise, high stress, and poor relations with co-workers and management. Limitations: This review is limited to English publications. A large number of reviewed studies (70%) were inadmissible due to issues of bias, thus limiting the amount of primary evidence. The uncertainties surrounding presenteeism measurement is of significant concern as a source of bias. Conclusions: The presenteeism literature is young and heterogeneous. There is preliminary evidence that some WHP programs can positively affect presenteeism and that certain risk factors are of importance. Future research would benefit from standard presenteeism metrics and studies conducted across a broad range of workplace settings.

BMC public health · systematic review · 191 citationsread the source →

Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial.

Background: Stereotactic ablative body radiotherapy (SABR) is an emerging treatment option for oligometastatic prostate cancer. However, limited prospective evidence is available. Objective: To determine the safety and feasibility of single fraction SABR for patients with oligometastatic prostate cancer. Secondary endpoints were local and distant progression-free survival (LPFS and DPFS), toxicity, quality of life (QoL), and prostate-specific antigen response. Design, setting, and participants: In a prospective clinical trial, patients were screened with computed tomography, bone scan, and sodium fluoride positron emission tomography scan and had one to three oligometastases. Kaplan-Meier methods were used to determine LPFS and DPFS. Toxicity was graded using Common Terminology Criteria for Adverse Event version 4.0. QoL was assessed using European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-BM22 at 1, 3,12, and 24 mo. Intervention: A single fraction of 20-Gy SABR to each lesion. Results and limitations: Between 2013 and 2014, 33 consecutive patients received SABR to a total of 50 oligometastases and were followed for 2 yr. The median age was 70 yr. The Gleason score was ≥8 in 15 patients (45%). Twenty patients had bone only, 12 had node only, and one had mixed disease. SABR was feasible and delivered as planned in 97% of cases. There was one grade 3 adverse event (3.0%, vertebral fracture). No patient died. The 1 and 2-yr LPFS was 97% (95% confidence interval [CI]: 91-100) and 93% (95% CI: 84-100), and DPFS was 58% (95% CI: 43-77) and 39% (95% CI: 25-60), respectively. In those not on androgen deprivation therapy (ADT; n=22), the 2-yr freedom from ADT was 48%. There was no significant difference from baseline QoL observed. Limitations include small sample size, limited duration of follow-up, and lack of a control arm. Conclusions: A single SABR session was feasible and associated with low morbidity in this cohort. Over one-third of patients did not progress and were free from ADT at 2-yr. QoL measures were maintained with this treatment strategy. Patient summary: This clinical trial investigated single treatment stereotactic radiotherapy for low volume advanced prostate cancer. The approach was found to be safe with avoidance of hormone therapy in almost half of the participants at 2 yr.

European urology · clinical trial · 222 citationsread the source →

Efficacy of Emotionally Focused Therapy among Spanish-speaking couples: study protocol of a randomized clinical trial in Argentina, Costa Rica, Guatemala, Mexico, and Spain

BACKGROUND: Couple relationship distress is common and associated with poor physical, psychological, and relational outcomes for both partners. Emotionally Focused Therapy for couples (EFT) is a short-term structured approach based on attachment theory that integrates a humanistic, experiential approach to restructuring emotional experience and a systemic structural approach to restructuring interactions. This model has been shown to be an effective treatment for couple distress. The supporting research, however, has only been conducted with English-speaking couples. Despite Spanish being the second-most spoken language and meaningful cultural differences between English- and Spanish-speaking countries, the efficacy of EFT has not been examined in this cultural context. This study will examine the efficacy of EFT in this particular context and advance the understanding of potential mechanisms of change. METHODS: We will use a multicenter randomized wait-list controlled design to examine the efficacy of EFT in a Spanish-speaking sample of moderately distressed couples. One hundred forty individuals in 70 couples in Argentina, Costa Rica, Guatemala, Mexico, and Spain will be randomly assigned to receive 19-21 sessions of EFT or be placed on a waitlist. Outcomes on a range of relational and individual mental health variables will be assessed prior to random assignment, throughout treatment, and at the conclusion of treatment. Primary outcomes will include dyadic adjustment, couple satisfaction, and attachment. Secondary variables, such as loneliness, parenting, affective communication, and sexual satisfaction, will be included as potential mediators of the treatment effect. Couples in the treatment group will also be assessed at 3-, 6-, 12-, 18-, and 24-month follow-ups. Process variables such as the therapeutic alliance will also be assessed routinely in couples assigned to the treatment group. Couples in the waitlist will receive a psycho-educational program based on EFT after completing the study. DISCUSSION: This study will be the first RCT of Emotionally Focused Therapy in a Spanish-speaking context. The results of the study will inform researchers interested in whether treatments developed and tested in the USA and Canada can be effective in differing cultural contexts. It may also point researchers and clinicians to areas where cultural adaptation is needed to improve efficacy. TRIAL REGISTRATION: ClinicalTrials.gov NCT04277325. Registered on February 20, 2020.

Trials · clinical trial · 4 citationsread the source →

Evaluation of the BALANCE Program as a Digital Therapeutic Solution for Type 2 Diabetes Management: Protocol for a Prospective Lifestyle Intervention Study.

Background: Type 2 diabetes mellitus (T2DM) is a growing global health concern. In 2016, 9.7% of Bruneian adults aged 18 to 69 years had diabetes, making it the third leading cause of death. Effective self-management can mitigate complications that require health care interventions and lower health care costs. Brunei Darussalam has deployed BruHealth, a national mobile health platform synced with the Brunei Health Information Management System, allowing patients to access health records, schedule appointments, and explore medical articles. A digital therapeutics module for T2DM (diabetes mellitus digital therapeutics [DM DTx]) has been developed, consisting of a digital lifestyle intervention module within BruHealth and a separate health care professional portal for health coaches. The 16-week BALANCE program aims to support self-management. This study explores the efficacy of DM DTx in managing T2DM through digital lifestyle interventions. Objective: The primary objective is to determine the proportion of participants who achieve at least a 0.6% reduction in glycated hemoglobin after 16 weeks. Secondary objectives include evaluating changes in glycated hemoglobin, fasting lipid profile, blood glucose, BMI, and waist circumference and analyzing participant feedback. Given the predominantly Muslim population, the study also aims to gain insight into fasting practices for Muslim participants with T2DM. Methods: This single-arm, nonrandomized intervention study involves adults aged 18 to 70 years with T2DM. Participants complete a fully online 16-week program via BruHealth that includes diabetes self-management education, personalized diet and exercise plans, self-monitoring tools (eg, glucometer and smartwatch), and support from health coaches through video consultations and instant messaging. Anthropometric and biochemical measures are collected at baseline and after the intervention. Data sources include the Brunei Health Information Management System, BruHealth app logs, and the health care professional portal. Descriptive statistics will summarize participant characteristics and outcomes. Paired 2-tailed t tests or Wilcoxon signed-rank tests will compare the results before and after the intervention. Subgroup analyses will explore outcomes based on glycemic changes, BMI, medication type, and program engagement. Participant feedback will be qualitatively analyzed. Fasting risk in Muslim participants will be stratified using the International Diabetes Federation-Diabetes and Ramadan Alliance Risk score. Results: Recruitment began on August 20, 2024, following project approval in July 2024, and continued until July 2025. By the end of data collection on November 12, 2025, a total of 459 participants had been enrolled, and 422 (91.9%) had completed the program. Data analysis is currently ongoing, with results expected in early 2026. Conclusions: Self-management mobile health apps are promising tools for chronic disease management, including T2DM. The BALANCE program is Brunei's first national-scale study evaluating a fully online T2DM intervention. Localization to a region's population may support improved health outcomes. International registered report identifier (irrid): DERR1-10.2196/73964.

JMIR research protocols · clinical trial · 1 citationsread the source →

Virtual reality exposure therapy and standard (in vivo) exposure therapy in the treatment of fear of flying.

This controlled clinical trial tested virtual reality exposure (VRE) therapy for the fear of flying (FOF), a relatively new and innovative way to do exposure therapy, and compared it to standard (in vivo) exposure therapy (SE) and a wait list (WL) control with a 6- and 12-month follow-up. Eighty-three participants with FOF were randomly assigned to VRE, SE, or WL. Seventy-five participants, 25 per group, completed the study. Twenty-three WL participants completed randomly assigned treatment following the waiting period. Treatment consisted of 4 sessions of anxiety management training followed either by exposure to a virtual airplane (VRE) or an actual airplane at the airport (SE) conducted over 6 weeks. Results indicate that VRE was superior to WL on all measures, including willingness to fly on the posttreatment flight (76% for VRE and SE; 20% for WL). VRE and SE were essentially equivalent on standardized questionnaires, willingness to fly, anxiety ratings during the flight, self-ratings of improvement, and patient satisfaction with treatment. Follow-up assessments at 6 and 12 months indicated that treatment gains were maintained, with more than 70% of respondents from both groups reporting continued flying at follow-up. Based on these findings, the use of VRE in the treatment of FOF was supported in this controlled study, suggesting that experiences in the virtual world can change experiences in the real world.

Behavior therapy · randomised controlled trial · 90 citationsread the source →

What is a meaningful change in physical performance? Findings from a clinical trial in older adults (the LIFE-P study).

Objective: Performance measures provide important information, but the meaning of change in these measures is not well known. The purpose of this research is to 1) examine the effect of treatment assignment on the relationship between self-report and performance; 2) to estimate the magnitude of meaningful change in 400-meter walk time (400MWT), 4-meter gait speed (4MGS), and Short Physical Performance Battery (SPPB) and 3) to evaluate the effect of direction of change on estimates of magnitude. Design: This is a secondary analysis of data from the LIFE-P study, a single blinded randomized clinical trial. Using change over one year, we applied distribution-based and anchor-based methods for self-reported mobility to estimate minimally important and substantial change in 400MWT, 4MGS and SPPB. Setting: Four university-based clinical research sites. Participants: Sedentary adults aged 70-89 whose SPPB scores were less than 10 and who were able to complete a 400MW at baseline (n=424). Interventions: A structured exercise program versus health education. Measurements: 400MWT, 4MGS, SPPB. Results: Relationships between self-report and performance measures were consistent between treatment arms. Minimally significant change estimates were 400MWT: 20-30 seconds, 4MGS: 0.03-0.05m/s and SPPB: 0.3 - 0.8 points. Substantial changes were 400MWT: 50-60 seconds, 4MGS: 0.08m/s, SPPB: 0.4 - 1.5 points. Magnitudes of change for improvement and decline were not significantly different. Conclusions: The magnitude of clinically important change in physical performance measures is reasonably consistent using several analytic techniques and appears to be achievable in clinical trials of exercise. Due to limited power, the effect of direction of change on estimates of magnitude remains uncertain.

The journal of nutrition, health & aging · randomised controlled trial · 388 citationsread the source →

Efficacy of extended-release naltrexone in alcohol-dependent patients who are abstinent before treatment.

Extended-release naltrexone (XR-NTX) is a once-a-month injectable formulation that is Food and Drug Administration-approved for the treatment of alcohol dependence in patients able to abstain from alcohol before treatment initiation. This paper presents the results of an analysis of efficacy data from a subgroup of patients with 4 days or more of voluntary abstinence before treatment initiation (n = 82) on a wide range of drinking-related outcomes. In these patients, all of whom received counseling, the rate of abstinence was severalfold higher for XR-NTX 380 mg compared with placebo: median time to first drink was 41 days versus 12 days, respectively; rate of continuous abstinence at end of the study was 32% versus 11% (P = 0.02). Extended-release naltrexone 380 mg, compared with placebo, substantially increased time to first heavy drinking event (>180 days vs 20 days; P = 0.04) and decreased the median number of any drinking days per month by 90% (0.7 vs 7.2; P = 0.005) and heavy drinking days per month by 93% (0.2 days vs 2.9 days; P = 0.007). The XR-NTX 380 mg group also had more than twice as many responders compared with placebo (70% vs 30%; P = 0.006; responder defined as having no more than 2 heavy drinking days in any consecutive 28-day period) and experienced greater improvement in gamma-glutamyl transpeptidase levels (P = 0.03). Outcomes for XR-NTX 190 mg (n = 26) were generally intermediate, demonstrating a dose-response effect. In conclusion, XR-NTX 380 mg prolonged abstinence and reduced the number of heavy drinking days and drinking days in patients who were abstinent for as few as 4 days before treatment initiation.

Journal of clinical psychopharmacology · randomised controlled trial · 89 citationsread the source →

Family-centered advance care planning for teens with cancer.

Importance: Advance care planning (ACP) prepares patients and their families for future health care decisions; however, the needs of adolescent oncology patients for participation in ACP have not been well studied. Objective: To examine the efficacy of family-centered ACP. Design and setting: Two-group randomized controlled trial in a pediatric oncology program. Participants: Sixty adolescents aged 14 to 21 years with cancer and their surrogates or families were enrolled in the study between January 17, 2011, and March 29, 2012. Intervention: Thirty dyads received 3- to 60-minute sessions 1 week apart. Intervention dyads completed (1) the Lyon Family-Centered ACP Survey, (2) the Respecting Choices interview, and (3) Five Wishes. Control subjects received standard care plus information. Main outcome measures: Statement of treatment preferences and Decisional Conflict Scale score. Results: The mean age of the adolescents was 16 years; 36 (60%) were male, 30 (50%) white, 26 (43%) black, and 4 (7%) Asian. Diagnoses were as follows: leukemia (14 patients [47%]), brain tumor (8 [27%]), solid tumor (6 [20%]), and lymphoma (2 [7%]). Significantly increased congruence was observed for intervention dyads compared with controls for 4 of the 6 disease-specific scenarios; for example, for situation 2 ("treatment would extend my life by not more than 2 to 3 months"), intervention dyads demonstrated higher congruence (κ = 0.660; P < .001) vs control dyads (κ = -0.0636; P = .70). Intervention adolescents (100%) wanted their families to do what is best at the time, whereas fewer control adolescents (62%) gave families this leeway. Intervention adolescents were significantly better informed about end-of-life decisions (t = 2.93; effect size, 0.961; 95% CI, 0.742-1.180; P = .007). Intervention families were more likely to concur on limiting treatments than controls. An ethnic difference was found in only one situation. Conclusions: Advance care planning enabled families to understand and honor their adolescents' wishes. Intervention dyads were more likely than controls to limit treatments. Underserved African American families were willing to participate.

JAMA pediatrics · randomised controlled trial · 149 citationsread the source →

The Effects of a Mindfulness-Based Intervention on Emotional Distress, Quality of Life, and HbA1c in Outpatients With Diabetes (DiaMind)

OBJECTIVE: Emotional distress is common in outpatients with diabetes, affecting ∼20-40% of the patients. The aim of this study was to determine the effectiveness of group therapy with Mindfulness-Based Cognitive Therapy (MBCT), relative to usual care, for patients with diabetes with regard to reducing emotional distress and improving health-related quality of life and glycemic control. RESEARCH DESIGN AND METHODS: In the present randomized controlled trial, 139 outpatients with diabetes (type 1 or type 2) and low levels of emotional well-being were randomized to MBCT (n = 70) or a waiting list group (n = 69). Primary outcomes were perceived stress (Perceived Stress Scale), anxiety and depressive symptoms (Hospital Anxiety and Depression Scale), mood (Profiles of Mood States), and diabetes-specific distress (Problem Areas In Diabetes). Secondary outcomes were health-related quality of life (12-Item Short-Form Health Survey), and glycemic control (HbA(1c)). Assessments were conducted at baseline and at 4 and 8 weeks of follow-up. RESULTS: Compared with control, MBCT was more effective in reducing stress (P < 0.001, Cohen d = 0.70), depressive symptoms (P = 0.006, d = 0.59), and anxiety (P = 0.019, d = 0.44). In addition, MBCT was more effective in improving quality of life (mental: P = 0.003, d = 0.55; physical: P = 0.032, d = 0.40). We found no significant effect on HbA(1c) or diabetes-specific distress, although patients with elevated diabetes distress in the MBCT group tended to show a decrease in diabetes distress (P = 0.07, d = 0.70) compared with the control group. CONCLUSIONS: Compared with usual care, MBCT resulted in a reduction of emotional distress and an increase in health-related quality of life in diabetic patients who had lower levels of emotional well-being.

Diabetes Care · randomised controlled trial · 168 citationsread the source →

Tadalafil for prevention of erectile dysfunction after radiotherapy for prostate cancer: the Radiation Therapy Oncology Group [0831] randomized clinical trial.

Importance: Tadalafil is used to treat erectile dysfunction after prostate cancer treatment, but its role as a preventive agent is undefined. Objectives: To determine primarily whether tadalafil preserved erectile function in men treated with radiotherapy for prostate cancer, and secondarily to determine whether participant- or partner-reported overall sexual function and sexual and marital satisfaction were affected. Design, setting, and participants: Stratified, placebo-controlled, double-blind, parallel-group study with 1:1 randomization at 76 community-based and tertiary medical sites in the United States and Canada. Two hundred forty-two participants with intact erectile function scheduled to receive radiotherapy for prostate cancer were recruited between November 2009 and February 2012 with follow-up through March 2013. Interventions: One hundred twenty-one participants were assigned 5 mg of tadalafil daily and 121 were assigned placebo for 24 weeks starting with external radiotherapy (63%) or brachytherapy (37%). Participant-reported International Index of Erectile Function response before radiotherapy and at weeks 2 and 4, between weeks 20 and 24, between weeks 28 and 30, and 1 year thereafter. Participants and partners could respond also to the Sexual Adjustment Questionnaire and to the Locke Marital Adjustment Test before radiotherapy, between weeks 20 and 24 and weeks 28 and 30, and at 1 year. Main outcomes and measures: Primary outcome was off-drug spontaneous erectile function 28 to 30 weeks after radiotherapy started. Secondary end points were spontaneous erection at 1 year; overall sexual function and satisfaction; marital adjustment; and partner-reported satisfaction and marital adjustment at 28 to 30 weeks and 1 year, predictors of tadalafil response; and adverse events. Results: Among 221 evaluable participants, 80 (79%; 95% CI, 70%-88%) assigned to receive tadalafil retained erectile function between weeks 28 and 30 compared with 61 (74%; 95% CI, 63%-85%) assigned to receive placebo (P = .49); an absolute difference of 5% (95% CI, -9% to 19%). A significant difference was also not observed at 1 year (72%; 95% CI, 60%-84% vs 71%; 95% CI, 59%-84%; P = .93). Tadalafil was not associated with significantly improved overall sexual function or satisfaction; a significant difference was not observed in any domain subscale. Partners of men assigned tadalafil noted no significant effect on sexual satisfaction, and marital adjustment was not significantly improved in participants or partners. Conclusions and relevance: Among men undergoing radiotherapy for prostate cancer, daily use of tadalafil compared with placebo did not result in improved erectile function. These findings do not support daily use of tadalafil to prevent erectile dysfunction in these patients. Trial registration: clinicaltrials.gov Identifier: NCT00931528.

JAMA · randomised controlled trial · 44 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 →

Performance characteristics and clinical utility of diagnostic criteria proposals in bereaved treatment-seeking patients.

Background: Persistent complex bereavement disorder (PCBD) is a protracted form of grief included in DSM Section 3 indicating a need for more research. Two other criteria sets [prolonged grief disorder (PGD) and complicated grief (CG) disorder] are also currently in use by researchers. This study evaluates rates of diagnosis of each proposed criteria set in a clinical sample of bereaved individuals participating in clinical research. Method: Two groups in which persistent grief was judged to be present or absent completed an assessment instrument that included items needed to diagnose PCBD as well as PGD and CG. One group included grief treatment-seeking participants in our multicenter National Institute of Mental Health (NIMH)-sponsored study who scored ⩾30 on the Inventory of Complicated Grief (ICG) and the other comprised bereaved adults enrolled in clinical research studies who scored <20 on the ICG. Rates of diagnosis were determined for proposed PCBD, PGD and CG criteria. Results: PCBD criteria diagnosed 70 [95% confidence interval (CI) 64.2-75.8] % of the grief treatment-seeking group, PGD criteria identified 59.6 (95% CI 53.4-65.8) % of these individuals and CG criteria identified 99.6 (95% CI 98.8-100.0) %. None of the three proposed criteria identified any cases in the bereaved comparison group. Conclusions: Both proposed DSM-5 criteria for PCBD and criteria for PGD appear to be too restrictive as they failed to identify substantial numbers of treatment-seeking individuals with clinically significant levels of grief-related distress and impairment. Use of CG criteria or a similar algorithm appears to be warranted.

Psychological medicine · cohort or longitudinal · 22 citationsread the source →

Improved quality of life at end of life related to home-based palliative care in children with cancer.

Background: Nearly 2000 children die due to a malignancy in the United States annually. Emerging data suggest that home is the desired location of care for children with cancer at end of life. However, one obstacle to enrollment in a pediatric palliative care (PPC) home care program may be fear that distressing symptoms at end of life cannot be adequately managed outside the hospital. Objective: To compare the symptom distress and quality-of-life experience for children who received concurrent end-of-life care from a PPC home care program (PPC/Oncology) with that of those who died without exposure to the PPC program (Oncology). Methods: We conducted a retrospective survey study of a cohort of bereaved parents of children who died of cancer between 2002 and 2008 at a U.S. tertiary pediatric institution. Results: Sixty bereaved parents were surveyed (50% PPC/Oncology). Prevalence of constipation and high distress from fatigue were more common in the PPC/Oncology group; other distressing symptoms were similar between groups, showing room for improvement. Children who received PPC/Oncology were significantly more likely to have fun (70% versus 45%), to experience events that added meaning to life (89% versus 63%), and to die at home (93% versus 20%). Conclusions: This is the first North American study to assess outcomes among children with cancer who received concurrent oncology and palliative home care compared with those who received oncology care alone. Symptom distress experiences were similar in groups. However, children enrolled in a PPC home care program appear to have improved quality of life and are more likely to die at home.

Journal of palliative medicine · cohort or longitudinal · 140 citationsread the source →

Association of hearing impairment and mortality in older adults.

Background: Hearing impairment (HI) is highly prevalent in older adults and is associated with social isolation, depression, and risk of dementia. Whether HI is associated with broader downstream outcomes is unclear. We undertook this study to determine whether audiometric HI is associated with mortality in older adults. Methods: Prospective observational data from 1,958 adults ≥70 years of age from the Health, Aging, and Body Composition Study were analyzed using Cox proportional hazards regression. Participants were followed for 8 years after audiometric examination. Mortality was adjudicated by obtaining death certificates. Hearing was defined as the pure-tone average of hearing thresholds in decibels re: hearing level (dB HL) at frequencies from 0.5 to 4kHz. HI was defined as pure-tone average >25 dB HL in the better ear. Results: Of the 1,146 participants with HI, 492 (42.9%) died compared with 255 (31.4%) of the 812 with normal hearing (odds ratio = 1.64, 95% CI: 1.36-1.98). After adjustment for demographics and cardiovascular risk factors, HI was associated with a 20% increased mortality risk compared with normal hearing (hazard ratio = 1.20, 95% CI: 1.03-1.41). Confirmatory analyses treating HI as a continuous predictor yielded similar results, demonstrating a nonlinear increase in mortality risk with increasing HI (hazard ratio = 1.14, 95% CI: 1.00-1.29 per 10 dB of threshold elevation up to 35 dB HL). Conclusions: HI in older adults is associated with increased mortality, independent of demographics and cardiovascular risk factors. Further research is necessary to understand the basis of this association and whether these pathways might be amenable to hearing rehabilitation.

The journals of gerontology. Series A, Biological sciences and medical sciences · cohort or longitudinal · 106 citationsread the source →

Trajectories of anxiety and depressive symptoms during enforced isolation due to COVID-19 in England: a longitudinal observational study.

Background: There is major concern about the impact of the global COVID-19 outbreak on mental health. Several studies suggest that mental health deteriorated in many countries before and during enforced isolation (ie, lockdown), but it remains unknown how mental health has changed week by week over the course of the COVID-19 pandemic. This study aimed to explore the trajectories of anxiety and depression over the 20 weeks after lockdown was announced in England, and compare the growth trajectories by individual characteristics. Methods: In this prospective longitudinal observational study, we analysed data from the UCL COVID-19 Social Study, a panel study weighted to population proportions, which collects information on anxiety (using the Generalised Anxiety Disorder assessment) and depressive symptoms (using the Patient Health Questionnaire) weekly in the UK since March 21, 2020. We included data from adults living in England who had at least three repeated measures between March 23 and Aug 9, 2020. Analyses were done using latent growth models, which were fitted to account for sociodemographic and health covariates. Findings: Between March 23, and Aug 9, data from over 70 000 adults were collected in the UCL COVID-19 Social Study. When including participants living in England with three follow-up measures and no missing values, our analytic sample consisted of 36 520 participants. The average depression score was 6·6 (SD=6·0, range 0-27) and the average anxiety score 5·7 (SD=5·6, range 0-21) in week 1. Anxiety and depression levels both declined across the first 20 weeks following the introduction of lockdown in England (b=-1·93, SE=0·26, p<0·0001 for anxiety; b=-2·52, SE=0·28, p<0·0001 for depressive symptoms). The fastest decreases were seen across the strict lockdown period (between weeks 2 and 5), with symptoms plateauing as further lockdown easing measures were introduced (between weeks 16 and 20). Being a woman or younger, having lower educational attainment, lower income, or pre-existing mental health conditions, and living alone or with children were all risk factors for higher levels of anxiety and depression at the start of lockdown. Many of these inequalities in experiences were reduced as lockdown continued, but differences were still evident 20 weeks after the start of lockdown. Interpretation: These data suggest that the highest levels of depression and anxiety occurred in the early stages of lockdown but declined fairly rapidly, possibly because individuals adapted to circumstances. Our findings emphasise the importance of supporting individuals in the lead-up to future lockdowns to try to reduce distress, and highlight that groups already at risk for poor mental health before the pandemic have remained at risk throughout lockdown and its aftermath. Funding: Nuffield Foundation, UK Research and Innovation, Wellcome Trust.

The lancet. Psychiatry · cohort or longitudinal · 745 citationsread the source →

Recovery and outcomes after the acute respiratory distress syndrome (ARDS) in patients and their family caregivers.

Outcomes after acute respiratory distress syndrome (ARDS) are similar to those of other survivors of critical illness and largely affect the nerve, muscle, and central nervous system but also include a constellation of varied physical devastations ranging from contractures and frozen joints to tooth loss and cosmesis. Compromised quality of life is related to a spectrum of impairment of physical, social, emotional, and neurocognitive function and to a much lesser extent discrete pulmonary disability. Intensive care unit-acquired weakness (ICUAW) is ubiquitous and includes contributions from both critical illness polyneuropathy and myopathy, and recovery from these lesions may be incomplete at 5 years after ICU discharge. Cognitive impairment in ARDS survivors ranges from 70 to 100 % at hospital discharge, 46 to 80 % at 1 year, and 20 % at 5 years, and mood disorders including depression and post-traumatic stress disorder (PTSD) are also sustained and prevalent. Robust multidisciplinary and longitudinal interventions that improve these outcomes are still uncertain and data in our literature are conflicting. Studies are needed in family members of ARDS survivors to better understand long-term outcomes of the post-ICU family syndrome and to evaluate how it affects patient recovery.

Intensive care medicine · review · 273 citationsread the source →

Visual outcome in infants born to drug-misusing mothers prescribed methadone in pregnancy.

Background: Flash visual evoked potentials (VEPs) were abnormal in a cohort of 100 neonates exposed to maintenance methadone in utero. This prospective cohort study now describes clinical visual and electrophysiological outcomes at 6 months. Methods: Visual assessment included modified Atkinson test battery; strabismus, nystagmus, reduced visual acuity, delayed visual maturation or refractive error (>3 dioptres) defined a fail. Pattern-onset VEPs were recorded to 120', 60' and 15' checks. Results: 81 drug-exposed and 26 comparison infants (79% and 52% of the original cohorts) were assessed at a median age of 27 weeks (range 26-30). 90% of drug-exposed infants had been additionally exposed to illicit drugs and 41% to excess alcohol in utero. 40% of the drug-exposed cohort failed clinical visual assessment: the relative risk of abnormal assessment was 5.1 (95% CI 1.3 to 20; p=0.02). Nystagmus was particularly common. VEP peak times were slower and amplitudes smaller in drug-exposed infants, of whom 70% had one or more abnormal VEP parameter. Abnormal visual outcome at 6 months was not associated with the pattern of additional drug exposure or a history of neonatal abstinence. Conclusions: Abnormal visual electrophysiology in infants born to drug-misusing mothers prescribed maintenance methadone persists to 6 months of age, and is associated with abnormal clinical visual assessment.

The British journal of ophthalmology · cohort or longitudinal · 53 citationsread the source →

Secular trends in self reported sexual activity and satisfaction in Swedish 70 year olds: cross sectional survey of four populations, 1971-2001.

Objective: To study secular trends in self reported sexual behaviour among 70 year olds. Design: Cross sectional survey. Settings Four samples representative of the general population in Gothenburg, Sweden. Participants: 1506 adults (946 women, 560 men) examined in 1971-2, 1976-7, 1992-3, and 2000-1. Main outcome measures: Sexual intercourse, attitudes to sexuality in later life, sexual dysfunctions, and marital satisfaction. Results: From 1971 to 2000 the proportion of 70 year olds reporting sexual intercourse increased among all groups: married men from 52% to 68% (P=0.002), married women from 38% to 56% (P=0.001), unmarried men from 30% to 54% (P=0.016), and unmarried women from 0.8% to 12% (P<0.001). Men and women from later birth cohorts reported higher satisfaction with sexuality, fewer sexual dysfunctions, and more positive attitudes to sexuality in later life than those from earlier birth cohorts. A larger proportion of men (57% v 40%, P<0.001) and women (52% v 35%, P<0.001) reported very happy relationships in 2000-1 compared with those in 1971-2. Sexual debut before age 20 increased in both sexes: in men from 52% to 77% (P<0.001) and in women from 19% to 64% (P<0.001). Conclusion: Self reported quantity and quality of sexual experiences among Swedish 70 year olds has improved over a 30 year period.

BMJ (Clinical research ed.) · cohort or longitudinal · 123 citationsread the source →

Effectiveness of one-year pharmacological treatment of adult attention-deficit/hyperactivity disorder (ADHD): an open-label prospective study of time in treatment, dose, side-effects and comorbidity.

How to generalize from randomized placebo controlled trials of ADHD drug treatment in adults to 'real-world' clinical practice is intriguing. This open-labeled prospective observational study examined the effectiveness of long-term stimulant and non-stimulant medication in adult ADHD including dose, side-effects and comorbidity in a clinical setting. A specialized ADHD outpatient clinic gave previously non-medicated adults (n=250) with ADHD methylphenidate as first-line drug according to current guidelines. Patients who were non-tolerant or experiencing low efficacy were switched to amphetamine or atomoxetine. Primary outcomes were changes of ADHD-symptoms evaluated with the Adult ADHD Self-Report Scale (ASRS) and overall severity by the Global Assessment of Functioning (GAF). Secondary outcomes were measures of mental distress, and response on the Clinical-Global-Impressions-Improvement Scale. Data at baseline and follow-ups were compared in longitudinal mixed model analyses for time on-medication, dosage, comorbidity, and side-effects. As results, 232 patients (93%) completed examination at the 12 month endpoint, and 163 (70%) remained on medication. Compared with the patients who discontinued medication, those still on medication had greater percentage reduction in ASRS-scores (median 39%, versus 13%, P<0.001) and greater improvement of GAF (median 20% versus 4%, P<0.001) and secondary outcomes. Continued medication and higher cumulated doses showed significant associations to sustained improvement. Conversely, psychiatric comorbidity and side-effects were related to lower effectiveness and more frequent termination of medication. Taken together, one-year treatment with stimulants or atomoxetine was associated with a clinically significant reduction in ADHD symptoms and mental distress, and improvement of measured function. No serious adverse events were observed.

European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology · cohort or longitudinal · 37 citationsread the source →

A comparison between patients with dysfunctional breathing and patients with asthma.

Introduction: The term dysfunctional breathing (DB) has been introduced to describe patients who display a divergent breathing pattern and have breathing problems that cannot be attributed to a specific medical diagnosis such as asthma, chronic obstructive pulmonary disease or sensory hyper-reactivity. Objective: The objective of this study was to investigate similarities and differences in patients with DB, and patients with well-controlled asthma regarding health-related quality of life, anxiety, depression, sense of coherence (SOC), hyperventilation and effects on daily life. Methods: Twenty-five consecutive patients with DB, and 25 age- and sex-matched patients with asthma (ages 20-73 years) participated in the study. The diagnosis of DB was based on the presence of a dysfunctional breathing pattern and at least five symptoms associated with DB. Results: The group with DB had lower health-related quality of life (short form 36): vitality (mean) 47 vs 62, social functioning 70 vs 94 and role emotional 64 vs 94 (P < 0.05) than the asthmatic group. The DB group also had a higher prevalence of anxiety (56% vs 24%) and a lower SOC (134 vs 156) (P < 0.05). Hyperventilation, defined according to the Nijmegen symptoms questionnaire, was observed in 56% of patients with DB vs 20% in the asthma group (P = 0.02). Conclusions: The results of the study indicate that patients with DB are more disabled than patients with well-controlled asthma. There is a great need for more knowledge about breathing symptoms of a dysfunctional nature, to be able to identify and manage these patients adequately.

The clinical respiratory journal · cohort or longitudinal · 55 citationsread the source →

Associations of salivary cortisol with cognitive function in the Baltimore memory study.

Context: The stress responses of the hypothalamic-pituitary-adrenal axis can produce adverse effects on the brain. Previous studies have concluded that an elevated level of cortisol is a risk factor for cognitive dysfunction and decline in aging but have been limited by sex exclusion, restricted cognitive batteries, and small sample sizes. Objective: To examine associations among salivary cortisol metrics and cognitive domain scores in an urban adult population. Design, setting, and participants: A cross-sectional analysis was conducted using data from a longitudinal study involving 1140 Baltimore, Maryland, residents aged 50 to 70 years. Four salivary cortisol samples were obtained from 967 participants across 1 study visit (before, during, and after cognitive testing as well as at the end of the visit) from which 7 cortisol metrics were created. We examined associations of cortisol metrics with cognitive performance using multiple linear regression. Main outcome measures: Performance on 20 standard cognitive tests was measured and combined to form summary measures in 7 domains (language, processing speed, eye-hand coordination, executive functioning, verbal memory and learning, visual memory, and visuoconstruction). Results: Higher levels of pretest and mean cortisol as well as the area under the curve of cortisol over the study visit were associated with worse performance (P < .05) in 6 domains (language, processing speed, eye-hand coordination, executive functioning, verbal memory and learning, and visual memory). For instance, an interquartile range increase in the area under the curve was equivalent to a decrease in the language score expected from an increase in 5.6 (95% confidence interval, 4.2-7.1) years of age. Conclusions: Elevated cortisol was associated with poorer cognitive function across a range of domains in this large population-based study. We believe the findings are consistent with the hypothesis that hypothalamic-pituitary-adrenal axis dysregulation may be a risk factor for poorer cognitive performance in older persons.

Archives of general psychiatry · cohort or longitudinal · 188 citationsread the source →

Heterogeneity of phenotypes in severe asthmatics. The Belgian Severe Asthma Registry (BSAR).

Unlabelled: The Belgian severe asthma registry is a web-based registry encompassing demographic, clinical, functional and inflammatory data of severe asthmatics (SA), aiming at improving awareness, knowledge on its natural history and subphenotypes, and offering tools to optimize care of this asthma population. Methods: The cross-sectional analyses of this registry included 350 SA as defined by the ATS (2000) from 9 Belgian centres, with at least one year follow up. Results: Mean age was 55 ± 14 yrs. SA were more frequently female (57%) and atopic (70%). Late-onset asthma (≥40 yr) was observed in 31% of SA. Current smokers represented 12% while 31% were ex-smokers. In addition to high doses ICS + LABA, 65% of patients were receiving LTRA, 27% anti-IgE and 24% maintenance oral corticosteroids (8 mg (Interquartile range-IQR:4-8) methylprednisolone). Despite impaired airflow (median FEV1:67%; IQR: 52-81) only 65% had a post-bronchodilator FEV1/FVC ratio <70%. The median blood eosinophil count was 240/mm³. The median FENO was 26 ppb (IQR: 15-43) and 22% of SA had FENO ≥ 50 ppb. Induced sputum was successful in 86 patients. Eosinophilic asthma (sputum Eos ≥ 3%) was the predominant phenotype (55%) while neutrophilic (sputum Neu ≥ 76%) and paucigranulocytic asthma accounted for 22% and 17% respectively. Comorbidities included rhinitis and chronic rhinosinusitis (49%), nasal polyposis (19%), oesophageal reflux (36%), overweight and obesity (47%) and depression (19%). In addition, 8% had aspirin-induced asthma and 3% ABPA. Asthma was not well-controlled in 83% according to ACT < 20 and 77% with ACQ > 1.5. Conclusion: In this cohort of patients with severe asthma, the majority displayed indices of persistent airflow limitation and eosinophilic inflammation despite high-dose corticosteroids, suggesting potential for eosinophil-targeted biotherapies.

Respiratory medicine · cohort or longitudinal · 199 citationsread the source →