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CBT for late-life insomnia and the accuracy of sleep and wake perceptions: Results from a randomized-controlled trial.

Subjective and objective estimates of sleep are often discordant among individuals with insomnia who typically under-report sleep time and over-report wake time at night. This study examined the impact and durability of cognitive-behavioural therapy for insomnia on improving the accuracy of sleep and wake perceptions in older adults, and tested whether changes in sleep quality were related to changes in the accuracy of sleep/wake perceptions. One-hundred and fifty-nine older veterans (97% male, mean age 72.2 years) who met diagnostic criteria for insomnia disorder were randomized to: (1) cognitive-behavioural therapy for insomnia (n = 106); or (2) attention control (n = 53). Assessments were conducted at baseline, post-treatment, 6-months and 12-months follow-up. Sleep measures included objective (via wrist actigraphy) and subjective (via self-report diary) total sleep time and total wake time, along with Pittsburgh Sleep Quality Index score. Discrepancy was computed as the difference between objective and subjective estimates of wake and sleep. Minutes of discrepancy were compared between groups across time, as were the relationships between Pittsburgh Sleep Quality Index scores and subsequent changes in discrepancy. Compared with controls, participants randomized to cognitive-behavioural therapy for insomnia became more accurate (i.e. minutes discrepancy was reduced) in their perceptions of sleep/wake at post-treatment, 6-months and 12-months follow-up (p < .05). Improved Pittsburgh Sleep Quality Index scores at each study assessment preceded and predicted reduced discrepancy at the next study assessment (p < .05). Cognitive-behavioural therapy for insomnia reduces sleep/wake discrepancy among older adults with insomnia. The reductions may be driven by improvements in sleep quality. Improving sleep quality appears to be a viable path to improving sleep perception and may contribute to the underlying effectiveness of cognitive-behavioural therapy for insomnia.

Journal of sleep research · randomised controlled trial · 22 citationsread the source →

Effectiveness and cost-effectiveness of guided Internet- and mobile-based CBT for adolescents and young adults with chronic somatic conditions and comorbid depression and anxiety symptoms (youthCOACHCD): study protocol for a multicentre randomized controlled trial.

Background: Adolescents and young adults (AYA) with chronic somatic conditions have an increased risk of comorbid depression and anxiety symptoms. Internet- and mobile-based cognitive behavioural therapy (iCBT) might be one possibility to extend the access to evidence-based treatments. Studies suggest that guided iCBT can reduce anxiety and depression symptoms in AYA. However, little is known about the effectiveness of iCBT for AYA with chronic somatic conditions and comorbid symptoms of anxiety and/or depression in routine care. Evidence on the (cost-)effectiveness of iCBT is essential for its implementation in health care. Objectives and methods: This multicentre two-armed randomized controlled trial (RCT) aims to evaluate the (cost-) effectiveness of guided iCBT (youthCOACHCD) in addition to treatment as usual (TAU) compared to enhanced treatment as usual (TAU+) in AYA aged 12-21 years with one of three chronic somatic conditions (type 1 diabetes, cystic fibrosis, or juvenile idiopathic arthritis). AYA with one of the chronic somatic conditions and elevated symptoms of anxiety or depression (Patient Health Questionnaire [PHQ-9] and/or Generalized Anxiety Disorder [GAD-7] Screener score ≥ 7) will be eligible for inclusion. We will recruit 212 patients (2 × n = 106) in routine care through three German patient registries. Assessments will take place at baseline and at 6 weeks, 3 months, 6 months, and 12 months post-randomization. The primary outcome will be combined depression and anxiety symptom severity as measured with the PHQ Anxiety and Depression Scale. Secondary outcomes will include health-related quality of life, coping strategies, self-efficacy, stress-related personal growth, social support, behavioural activation, adjustment and trauma-related symptoms, automatic thoughts, intervention satisfaction, working alliance, and Internet usage. The cost-effectiveness will be determined, and potential moderators and mediators of intervention effects will be explored. Discussion: iCBT might implicate novel ways to increase the access to evidence-based interventions in this specific population. The distinct focus on effectiveness and cost-effectiveness of youthCOACHCD in patients with chronic somatic conditions, as well as intervention safety, will most likely provide important new insights in the field of paediatric e-mental health. A particular strength of the present study is its implementation directly into routine collaborative health care. As such, this study will provide important insights for health care policy and stakeholders and indicate how iCBT can be integrated into existing health care systems. Trial registration: German Clinical Trials Register (DRKS), DRKS00017161. Registered on 17 September 2019.

Trials · clinical trial · 25 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 →

Changes in sexual functioning and sex hormone levels in women following bariatric surgery.

Importance: Obesity has been associated with impairments in sexual function and untoward changes in reproductive hormones in women. Relatively few studies have investigated changes in these domains following bariatric surgery. Objective: To investigate changes in sexual functioning, sex hormone levels, and relevant psychosocial constructs in women who underwent bariatric surgery. Design, setting, and participants: A prospective cohort study of 106 women from phase 2 of the Longitudinal Assessment of Bariatric Surgery who underwent bariatric surgery (median [interquartile range] body mass index, 44.5 [41.4-49.7]). Assessments were completed between 2006 and 2012. Interventions: Bariatric surgery was performed by a surgeon certified by the Longitudinal Assessment of Bariatric Surgery (85 women underwent a Roux-en-Y gastric bypass, and 21 women underwent laparoscopic adjustable gastric banding). Main outcomes and measures: Sexual functioning was assessed by use of the Female Sexual Function Index. Hormones were assessed by use of a blood assay. Quality of life, body image, depressive symptoms, and marital adjustment were assessed by use of validated questionnaires. Results: Women lost a mean 32.7% (95% CI, 30.7%-34.7%) of initial body weight at postoperative year 1 and a mean 33.5% (95% CI, 31.5%-35.6%) at postoperative year 2. Two years following surgery, women reported significant improvements in overall sexual functioning and specific domains of sexual functioning: arousal, lubrication, desires, and satisfaction. They also experienced significant changes at 2 years in all hormones of interest. Women reported significant improvements in most domains of quality of life, as well as body image and depressive symptoms, within the first year after surgery, with these improvements being maintained through the second postoperative year. Conclusions and relevance: Women who underwent bariatric surgery had significant improvements in overall sexual functioning, in most reproductive hormones of interest, and in psychosocial status. Improvements in sexual health can be added to the list of health benefits associated with bariatric surgery. Trial registration: clinicaltrials.gov Identifier: NCT00670098.

JAMA surgery · clinical trial · 74 citationsread the source →

Acute kidney injury is an independent risk factor for pediatric intensive care unit mortality, longer length of stay and prolonged mechanical ventilation in critically ill children: a two-center retrospective cohort study.

Introduction: In adults, small (< 50%) serum creatinine (SCr) increases predict mortality. It is unclear whether different baseline serum creatinine (bSCr) estimation methods affect findings of acute kidney injury (AKI)-outcome associations. We characterized pediatric AKI, evaluated the effect of bSCr estimation approaches on AKI-outcome associations and evaluated the use of small SCr increases to predict AKI development. Methods: We conducted a retrospective cohort database study of children (excluding postoperative cardiac or renal transplant patients) admitted to two pediatric intensive care units (PICUs) for at least one night in Montreal, QC, Canada. The AKI definition was based on the Acute Kidney Injury Network staging system, excluding the requirement of SCr increase within 48 hours, which was impossible to evaluate on the basis of our data set. We estimated bSCr two ways: (1) the lowest SCr level in the three months before admission or the average age- and gender-based norms (the standard method) or (2) by using average norms in all patients. Outcomes were PICU mortality and length of stay as well as required mechanical ventilation. We used multiple logistic regression analysis to evaluate AKI risk factors and the association between AKI and mortality. We used multiple linear regression analysis to evaluate the effect of AKI on other outcomes. We calculated diagnostic characteristics for early SCr increase (< 50%) to predict AKI development. Results: Of 2,106 admissions (mean age ± SD = 5.0 ± 5.5 years; 47% female), 377 patients (17.9%) developed AKI (using the standard bSCr method) during PICU admission. Higher Pediatric Risk of Mortality score, required mechanical ventilation, documented infection and having a bSCr measurement were independent predictors of AKI development. AKI was associated with increased mortality (adjusted odds ratio (OR) = 3.7, 95% confidence interval (95% CI) = 2.1 to 6.4, using the standard bSCr method; OR = 4.5, 95% CI = 2.6 to 7.9, using normative bSCr values in all patients). AKI was independently associated with longer PICU stay and required mechanical ventilation. In children with no admission AKI, the initial percentage SCr increase predicted AKI development (area under the curve = 0.67, 95% CI = 0.60 to 0.74). Conclusions: AKI is associated with increased mortality and morbidity in critically ill children, regardless of the bSCr used. Paying attention to small early SCr increases may contribute to early AKI diagnosis in conjunction with other new AKI biomarkers.

Critical care (London, England) · cohort or longitudinal · 254 citationsread the source →

Improving stress management, anxiety, and mental well-being in medical students through an online Mindfulness-Based Intervention: a randomized study.

Pressures and responsibilities of medical school put a strain on medical student's personal wellbeing, leading among all to high rates of anxiety, emotional discomfort and stress. In this work we evaluated the effectiveness of a comprehensive Mindfulness-Based Intervention (MBI) in reducing this load. The intervention comprised 10 twice-a-week Integral Meditation classes, dietary advice, and brief yoga sessions. We performed a randomized trial on two cohort of medical students from Italian universities: 239 in cohort 1 (106 treated and 133 controls), and 123 in cohort 2 (68 treated and 55 control) for a total sample of 362 students. Nine questionnaires for evaluating the effectiveness of our intervention on stress (PSS), state anxiety (STAIX-1), well-being (WEMWBS), mind-wandering (MW-S), overall distress (PANAS), emotion regulation (DERS), resilience (RS-14), and attentional control (ACS-C and ACS-D) were collected both pre and post intervention. Linear mixed effect models were run on the whole sample showing that, after multiple testing correction, our intervention was effective in reducing perceived stress (β = - 2.57 [- 4.02; - 1.12], p = 0.004), improving mental well-being (β = 2.82 [1.02; 4.63], p = 0.008) and emotional regulation (β = - 8.24 [- 12.98; - 3.51], p = 0.004), resilience (β = 3.79 [1.32; 6.26], p = 0.008), reducing the tendency to wander with the mind (β = - 0.70 [- 0.99; - 0.39], p = 0.0001), ameliorating the ability to maintain attention (AC-S (β = - 0.23 [- 0.44; - 0.02], p = 0.04) and AC-D (β = - 0.19 [- 0.36; - 0.01], p = 0.04)), and the overall distress (β = 1.84 [0.45; 3.23], p = 0.02).

Scientific reports · randomised controlled trial · 25 citationsread the source →

Stability and change in depressive symptoms from pregnancy to two months postpartum in childbearing immigrant women.

The present study explored changes in mental health and functional status from pregnancy to 2 months postpartum in a sample of 106 childbearing immigrant women. Three sets of variables were examined in relation to postpartum depressive symptomatology: (1) prenatal depression, worries, and somatic symptoms; (2) social relationships (marital quality and social support), and (3) factors related to migration (premigration stress and length of stay in the host country). We found that 37.7% of the women in this community sample scored above the cutpoint of 12 on the Edinburgh Postnatal Depression Scale; prenatal depressive and somatic symptoms, as well as marital quality, were the best predictors of postpartum depressive symptomatology. An examination of differing trajectories from pregnancy to the postpartum period suggests that women with relatively few somatic complaints, low levels of perinatal stress, and satisfactory marital relations were less likely to exhibit mental health problems during pregnancy and postpartum. Women who were not depressed prenatally but reported postpartum depressive symptomatology exhibited several predisposing risk factors during pregnancy: many somatic complaints, high perinatal anxiety, and premigration stress. Women who were depressed during pregnancy but not postpartum reported improved physical function after childbirth. The implications of these findings for screening childbearing immigrant women are discussed.

Archives of women's mental health · cohort or longitudinal · 75 citationsread the source →

Examining the role of cognitive fusion and experiential avoidance in predicting anxiety and depression.

Objectives: Acceptance and Commitment Therapy (ACT) proposes that cognitive fusion and experiential avoidance are inter-related processes underpinning distress. This study investigated whether worry, rumination, and stressful life events on the one hand and anxiety and depression on the other hand were mediated by cognitive fusion and experiential avoidance (bidirectional serial association). Design: A questionnaire design was conducted cross-sectionally in a clinical sample (study 1; N = 57) and cross-sectionally and longitudinally in a non-clinical student sample (study 2; N = 106 and N = 97 respectively). Methods: Participants completed measures of worry, rumination, stressful life events (predictors), cognitive fusion, experiential avoidance (mediators), anxiety, and depression (outcomes) at T1. In study 2, anxiety and depression were measured again 6 weeks later. Results: In the clinical sample, the bidirectional relationship between experiential avoidance and cognitive fusion accounted for a significant proportion of the association between rumination and depression, and stressful life events and anxiety and depression. The association between worry and anxiety was mediated by cognitive fusion → experiential avoidance only. In the non-clinical sample, in both cross-sectional and longitudinal analyses, cognitive fusion independently mediated the association between predictors and outcomes, as well as the experiential avoidance → cognitive fusion pathway. Conclusions: The bidirectional association between cognitive fusion and experiential avoidance was most predictive of distress in the clinical sample. In the non-clinical sample, cognitive fusion and the experiential avoidance → cognitive fusion pathway demonstrated more explanatory value. Given the cross-sectional nature of most of the data, the findings provide theoretical (as opposed to empirical) support for the models tested. Practitioner points: Interventions designed to reduce cognitive fusion may be a useful early intervention for sub-clinical anxiety and depression. Interventions focused on reducing both cognitive fusion and experiential avoidance may be helpful for individuals presenting with clinical anxiety and depression. Individuals presenting with particularly high levels of experiential avoidance may benefit from initial work defusing from difficult thoughts, as an inroad for reducing experiential avoidance, anxiety, and depression. Likewise, those with rigid cognitive fusion may benefit from initial work around acceptance skills to create a context that better supports defusion.

Psychology and psychotherapy · 54 citationsread the source →

Self-Compassion and Parenting in Mothers and Fathers with Depression.

Depression in parents impairs parenting and increases the risk of psychopathology among their children. Prevention and intervention could be informed by knowledge of the mechanisms that break the inter-generational transmission of psychopathology and build resilience in both parents and their children. We used data from two independent studies to examine whether higher levels of self-compassion were associated with better parenting and fewer emotional and behavioral problems in children of parents with a history of depression. Study 1 was a pilot trial of mindfulness-based cognitive therapy that included 38 parents with recurrent depression. Study 2 was a longitudinal study that consisted of 160 families, including 50 mothers and 40 fathers who had a history of depression. Families were followed up approximately 16 months after the first assessment (time 2; n = 106 families). In both studies, self-compassion was assessed with the Self-Compassion Scale. Parents reporting higher levels of self-compassion were more likely to attribute the cause of their children's behavior to external factors, were less critical, and used fewer distressed reactions to cope with their children's emotions. Parents' self-compassion was longitudinally associated with children's internalizing and externalizing problems, but these associations became nonsignificant after controlling for child gender, parent education, and depressive symptoms. Future larger scale and experimental designs need to examine whether interventions intended to increase self-compassion might reduce the use of negative parenting strategies and thereby the inter-generational transmission of psychopathology.

Mindfulness · 32 citationsread the source →

Trial Protocol: Cognitive functional therapy compared with combined manual therapy and motor control exercise for people with non-specific chronic low back pain: protocol for a randomised, controlled trial.

Introduction: Chronic low back pain is a public health problem, and there is strong evidence that it is associated with a complex interaction of biopsychosocial factors. Cognitive functional therapy is an intervention that deals with potentially modifiable multidimensional aspects of pain (eg, provocative cognitive, movement and lifestyle behaviours). There is evidence (from a single randomised, controlled trial) that cognitive functional therapy is better than combined manual therapy and motor control exercise. However, this study had significant methodological shortcomings including the failure to carry out an intention-to-treat analysis and a considerable loss of follow-up of participants. It is important to replicate this study in another domain through a randomised clinical trial with similar objectives but correcting these methodological shortcomings. Aim: To investigate the efficacy of cognitive functional therapy compared to combined manual therapy and exercise on pain and disability at 3 months in patients with chronic non-specific low back pain. Design: Two-group, randomised, multicentre controlled trial with blinded assessors. Participants and settings: One hundred and forty-eight participants with chronic low back pain that has persisted for >3months and no specific spinal pathology will be recruited from the school clinic of the Centro Universitário Augusto Motta and a private clinic in the city of Rio de Janeiro, Brazil. Intervention a: Four to 10 sessions of cognitive functional therapy. The physiotherapists who will treat the participants in the cognitive functional therapy group have previously attended 2 workshops with two different tutors of the method. Such physiotherapists have completed 106 hours of training, including workshops and patient examinations, as well as conducting a pilot study under the supervision of another physiotherapist with>3 years of clinical experience in cognitive functional therapy. Intervention b: Four to 10 sessions of combined manual therapy and motor control exercises. Participants in the combined manual therapy and exercise group will be treated by two physiotherapists with an average of >10years of clinical experience in manual therapy and motor control exercises, including isolated contractions of the deep abdominal muscles. Measurements: The primary outcome measures will be pain intensity and disability 3 months after randomisation. Secondary outcomes will be pain and disability assessed 6 and 12 months after randomisation, and both global perceived effect and patient satisfaction at 3, 6 and 12 months after randomisation. The potential outcome mediators will be assessed at 3 and 6 months after randomisation, with brief screening questions for anxiety, social isolation, catastrophisation, depression, fear of movement, stress and sleep. Non-specific predictors and moderators will include age, gender, duration of chronic low back pain, chronicity risk (Örebro and Start Back score), number of pain areas, stressful life event, MRI scan imaging, and family history. Analysis: Intention-to-treat analysis will be performed. Linear mixed models will be used to compare the mean differences in pain intensity, disability and global perceived effect between the intervention arms. The analysis of the effect of potential mediators of the treatment will be performed using the causal mediation methods described by Imai and colleagues. The baseline variables will be evaluated as predictors and moderators of treatment, including terms and interaction models. A level of statistical significance of 5% will be used in the analysis. All the analyses will be performed using RStudio. Significance: This study will investigate whether the results of the first cognitive functional therapy randomised clinical trial are reproducible. The present study will have a sample size capable of detecting clinically relevant effects of the treatment with a low risk of bias. In pragmatic terms, this clinical trial is designed to reproduce the intervention as it would be performed in clinical practice by a trained physiotherapist who works with cognitive functional therapy, which increases the relevance of this study. The combined manual therapy and exercise group comprises an intervention strategy widely used by physiotherapists to treat low back pain. As evidence of efficacy is still limited, the results of a randomised, controlled clinical trial of high methodological quality will help physiotherapists in clinical decision-making.

Journal of physiotherapy · randomised controlled trial · 9 citationsread the source →

Effects of a Combination of Three-Dimensional Virtual Reality and Hands-on Horticultural Therapy on Institutionalized Older Adults' Physical and Mental Health: Quasi-Experimental Design.

Background: Institutionalized older adults have limited ability to engage in horticultural activities that can improve their physical and mental health. Objective: This study explored the effects of a combination of 3D virtual reality and horticultural therapy on institutionalized older adults' physical and mental health. Methods: The study used a quasi-experimental design. A total of 106 older adults from 2 long-term care facilities were recruited and assigned to the experimental (n=59) or control (n=47) group. The experimental participants received a 9-week intervention. Both groups completed 3 assessments: at baseline, after the intervention, and 2 months later. The outcome variables included health status, meaning in life, perceived mattering, loneliness, and depression. Results: The experimental group demonstrated significantly improved health status (P<.001), meaning in life (P<.001), and perceived mattering (P<.001) as well as significantly reduced depression (P<.001) and loneliness (P<.001) compared to the control group immediately after the intervention; these effects persisted for up to 2 months. Conclusions: This study verified the beneficial effects of a combination of 3D virtual reality and hands-on horticultural therapy on older adults' health. These results could support the future successful implementation of similar programs for institutionalized older adults on a larger scale.

Journal of medical Internet research · 29 citationsread the source →

Using Participatory Design Methodologies to Co-Design and Culturally Adapt the Spanish Version of the Mental Health eClinic: Qualitative Study.

Background: The Mental Health eClinic (MHeC) aims to deliver best-practice clinical services to young people experiencing mental health problems by making clinical care accessible, affordable, and available to young people whenever and wherever they need it most. The original MHeC consists of home page with a visible triage system for those requiring urgent help; a online physical and mental health self-report assessment; a results dashboard; a booking and videoconferencing system; and the generation of a personalized well-being plan. Populations who do not speak English and reside in English-speaking countries are less likely to receive mental health care. In Australia, international students have been identified as disadvantaged compared with their peers; have weaker social support networks; and have higher rates of psychological distress. This scenario is acquiring significant relevance as Spanish-speaking migration is rapidly growing in Australia, and the mental health services for culturally and linguistically diverse populations are limited. Having a Spanish version (MHeC-S) of the Mental Health eClinic would greatly benefit these students. Objective: We used participatory design methodologies with users (young people aged 16-30 years, supportive others, and health professionals) to (1) conduct workshops with users to co-design and culturally adapt the MHeC; (2) inform the development of the MHeC-S alpha prototype; (3) test the usability of the MHeC-S alpha prototype; (4) translate, culturally adapt, and face-validate the MHeC-S self-report assessment; and (5) collect information to inform its beta prototype. Methods: A research and development cycle included several participatory design phases: co-design workshops; knowledge translation; language translation and cultural adaptation; and rapid prototyping and user testing of the MHeC-S alpha prototype. Results: We held 2 co-design workshops with 17 users (10 young people, 7 health professionals). A total of 15 participated in the one-on-one user testing sessions (7 young people, 5 health professionals, 3 supportive others). We collected 225 source documents, and thematic analysis resulted in 5 main themes (help-seeking barriers, technology platform, functionality, content, and user interface). A random sample of 106 source documents analyzed by 2 independent raters revealed almost perfect agreement for functionality (kappa=.86; P<.001) and content (kappa=.92; P<.001) and substantial agreement for the user interface (kappa=.785; P<.001). In this random sample, no annotations were coded for help-seeking barriers or the technology platform. Language was identified as the main barrier to getting medical or psychological services, and smartphones were the most-used device to access the internet. Acceptability was adequate for the prototype's 5 main elements: home page and triage system, self-report assessment, dashboard of results, booking and video visit system, and personalized well-being plan. The data also revealed gaps in the alpha prototype, such as the need for tailored assessment tools and a greater integration with Spanish-speaking services and communities. Spanish-language apps and e-tools, as well as online mental health information, were lacking. Conclusions: Through a research and development process, we co-designed and culturally adapted, developed and user tested, and evaluated the MHeC-S. By translating and culturally adapting the MHeC to Spanish, we aimed to increase accessibility and availability of e-mental health care in the developing world, and assist vulnerable populations that have migrated to English-speaking countries.

Journal of medical Internet research · 58 citationsread the source →

Telerehabilitation services for stroke.

Background: Telerehabilitation offers an alternate way of delivering rehabilitation services. Information and communication technologies are used to facilitate communication between the healthcare professional and the patient in a remote location. The use of telerehabilitation is becoming more viable as the speed and sophistication of communication technologies improve. However, it is currently unclear how effective this model of delivery is relative to rehabilitation delivered face-to-face or when added to usual care. Objectives: To determine whether the use of telerehabilitation leads to improved ability to perform activities of daily living amongst stroke survivors when compared with (1) in-person rehabilitation (when the clinician and the patient are at the same physical location and rehabilitation is provided face-to-face); or (2) no rehabilitation or usual care. Secondary objectives were to determine whether use of telerehabilitation leads to greater independence in self-care and domestic life and improved mobility, balance, health-related quality of life, depression, upper limb function, cognitive function or functional communication when compared with in-person rehabilitation and no rehabilitation. Additionally, we aimed to report on the presence of adverse events, cost-effectiveness, feasibility and levels of user satisfaction associated with telerehabilitation interventions. Search methods: We searched the Cochrane Stroke Group Trials Register (June 2019), the Cochrane Central Register of Controlled Trials (the Cochrane Library, Issue 6, 2019), MEDLINE (Ovid, 1946 to June 2019), Embase (1974 to June 2019), and eight additional databases. We searched trial registries and reference lists. Selection criteria: Randomised controlled trials (RCTs) of telerehabilitation in stroke. We included studies that compared telerehabilitation with in-person rehabilitation or no rehabilitation. In addition, we synthesised and described the results of RCTs that compared two different methods of delivering telerehabilitation services without an alternative group. We included rehabilitation programmes that used a combination of telerehabilitation and in-person rehabilitation provided that the greater proportion of intervention was provided via telerehabilitation. Data collection and analysis: Two review authors independently identified trials on the basis of prespecified inclusion criteria, extracted data and assessed risk of bias. A third review author moderated any disagreements. The review authors contacted investigators to ask for missing information. We used GRADE to assess the quality of the evidence and interpret findings. Main results: We included 22 trials in the review involving a total of 1937 participants. The studies ranged in size from the inclusion of 10 participants to 536 participants, and reporting quality was often inadequate, particularly in relation to random sequence generation and allocation concealment. Selective outcome reporting and incomplete outcome data were apparent in several studies. Study interventions and comparisons varied, meaning that, in many cases, it was inappropriate to pool studies. Intervention approaches included post-hospital discharge support programs, upper limb training, lower limb and mobility retraining and communication therapy for people with post-stroke language disorders. Studies were either conducted upon discharge from hospital or with people in the subacute or chronic phases following stroke. Primary outcome: we found moderate-quality evidence that there was no difference in activities of daily living between people who received a post-hospital discharge telerehabilitation intervention and those who received usual care (based on 2 studies with 661 participants (standardised mean difference (SMD) -0.00, 95% confidence interval (CI) -0.15 to 0.15)). We found low-quality evidence of no difference in effects on activities of daily living between telerehabilitation and in-person physical therapy programmes (based on 2 studies with 75 participants: SMD 0.03, 95% CI -0.43 to 0.48). Secondary outcomes: we found a low quality of evidence that there was no difference between telerehabilitation and in-person rehabilitation for balance outcomes (based on 3 studies with 106 participants: SMD 0.08, 95%CI -0.30 to 0.46). Pooling of three studies with 569 participants showed moderate-quality evidence that there was no difference between those who received post-discharge support interventions and those who received usual care on health-related quality of life (SMD 0.03, 95% CI -0.14 to 0.20). Similarly, pooling of six studies (with 1145 participants) found moderate-quality evidence that there was no difference in depressive symptoms when comparing post-discharge tele-support programs with usual care (SMD -0.04, 95% CI -0.19 to 0.11). We found no difference between groups for upper limb function (based on 3 studies with 170 participants: mean difference (MD) 1.23, 95% CI -2.17 to 4.64, low-quality evidence) when a computer program was used to remotely retrain upper limb function in comparison to in-person therapy. Evidence was insufficient to draw conclusions on the effects of telerehabilitation on mobility or participant satisfaction with the intervention. No studies evaluated the cost-effectiveness of telerehabilitation; however, five of the studies reported health service utilisation outcomes or costs of the interventions provided within the study. Two studies reported on adverse events, although no serious trial-related adverse events were reported. Authors' conclusions: While there is now an increasing number of RCTs testing the efficacy of telerehabilitation, it is hard to draw conclusions about the effects as interventions and comparators varied greatly across studies. In addition, there were few adequately powered studies and several studies included in this review were at risk of bias. At this point, there is only low or moderate-level evidence testing whether telerehabilitation is a more effective or similarly effective way to provide rehabilitation. Short-term post-hospital discharge telerehabilitation programmes have not been shown to reduce depressive symptoms, improve quality of life, or improve independence in activities of daily living when compared with usual care. Studies comparing telerehabilitation and in-person therapy have also not found significantly different outcomes between groups, suggesting that telerehabilitation is not inferior. Some studies reported that telerehabilitation was less expensive to provide but information was lacking about cost-effectiveness. Only two trials reported on whether or not any adverse events had occurred; these trials found no serious adverse events were related to telerehabilitation. The field is still emerging and more studies are needed to draw more definitive conclusions. In addition, while this review examined the efficacy of telerehabilitation when tested in randomised trials, studies that use mixed methods to evaluate the acceptability and feasibility of telehealth interventions are incredibly valuable in measuring outcomes.

The Cochrane database of systematic reviews · meta-analysis · 345 citationsread the source →

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

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

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

Subjective experience and meaning of delusions in psychosis: a systematic review and qualitative evidence synthesis.

Background: Delusions are a common transdiagnostic feature of psychotic disorders, and their treatment remains suboptimal. Despite the pressing need to better understand the nature, meaning, and course of these symptoms, research into the lived experience of delusional phenomena in psychosis is scarce. Thus, we aimed to explore the lived experience and subjective apprehension of delusions in help-seeking individuals with psychosis, regardless of diagnosis and thematic content of the delusion. Methods: In our systematic review and qualitative evidence synthesis, we searched MEDLINE, Embase, PsycINFO, CINAHL, and Web of Science for qualitative studies published in English from database inception, with the last search on Sept 9, 2021. Grey literature search and hand-searching of relevant journals were also done. Studies were eligible if they provided an analysis of lived experience of delusions or predelusional phenomena presented from the perspective of individuals (age 14-65 years) who had developed a clinical high-risk stage of psychosis, or a diagnosable affective or non-affective psychotic disorder (as clinically defined, self-reported, or assessed within the primary study). Studies with only a subset of relevant participants were eligible only if data for the population of interest were reported separately. Studies that did not discriminate between the experience of delusion and other positive symptoms (eg, hallucinations) were included only if data for delusions were reported separately or could be extracted. First-person accounts (and author interpretations) discussing changes in the sense of self, lived world, and meaning in relation to delusions were extracted and synthesised using a novel thematic synthesis approach informed by a critical realist stance and a phenomenological theoretical framework. Analytic themes were developed into a new overarching framework for understanding the emergence of delusional phenomena. The study was registered with PROSPERO, CRD42020222104. Findings: Of the 3265 records screened, 2115 were identified after duplicate removal. Of these, 1982 were excluded after title and abstract screening and 106 after full-text eligibility assessment. Of the 27 studies entering quality assessment, 24 eligible studies were included in the qualitative evidence synthesis, representing the perspectives of 373 help-seeking individuals with lived experience of delusions in the context of psychosis. Gender was reported as male (n=210), female (n=110), transgender (n=1), or not reported (n=52). Only 13 studies reported ethnicity, with White being predominant. The age of most participants ranged from 15 to 65 years. We found no eligible studies investigating subclinical or predelusional experiences in at-risk mental state populations through qualitative methods. Most studies were undertaken in western, educated, industrialised, rich, and democratic (WEIRD) societies, and most included participants had received or self-reported a diagnosis within the schizophrenia spectrum. Studies differed in relation to whether they focused on one kind or theme of delusion or delusional phenomena more generally as a unified category. Three superordinate themes relating to experiential changes and meanings in delusion were identified: (1) a radical rearrangement of the lived world dominated by intense emotions; (2) doubting, losing, and finding oneself again within delusional realities; and (3) searching for meaning, belonging, and coherence beyond mere dysfunction. Based on the review findings and thematic synthesis, we propose the Emergence Model of Delusion to advance understanding of delusional phenomena in psychosis. Interpretation: Delusions are best understood as strongly individualised and inherently complex phenomena emerging from a dynamic interplay between interdependent subpersonal, personal, interpersonal, and sociocultural processes. Integrative approaches to research on delusion, which consider their potential adaptiveness and favour explanatory pluralism, might be advantageous. Effective clinical care for individuals with psychosis might need adapting to match more closely, and take account of, the subjective experience and meaning of delusions as they are lived through, which might also help redress power imbalances and enduring epistemic injustices in mental health. Funding: Priestley Scholars, Wellcome Trust.

The lancet. Psychiatry · systematic review · 37 citationsread the source →

Telephone-Based Cognitive Behavioral Therapy for Insomnia in Perimenopausal and Postmenopausal Women With Vasomotor Symptoms: A MsFLASH Randomized Clinical Trial.

Importance: Effective, practical, nonpharmacologic therapies are needed to treat menopause-related insomnia symptoms in primary and women's specialty care settings. Objective: To evaluate the efficacy of telephone-based cognitive behavioral therapy for insomnia (CBT-I) vs menopause education control (MEC). Design, setting, and participants: A single-site, randomized clinical trial was conducted from September 1, 2013, to August 31, 2015, in western Washington State among 106 perimenopausal or postmenopausal women aged 40 to 65 years with moderate insomnia symptoms (Insomnia Severity Index [ISI] score, ≥12) and 2 or more daily hot flashes. Blinded assessments were conducted at baseline, 8, and 24 weeks postrandomization. An intent-to-treat analysis was conducted. Interventions: Six CBT-I or MEC telephone sessions in 8 weeks. Participants submitted weekly electronic sleep diaries and received group-specific written educational materials. The CBT-I sessions included sleep restriction, stimulus control, sleep hygiene education, cognitive restructuring, and behavioral homework; MEC sessions provided information about menopause and women's health. Main outcomes and measures: Primary outcome was scores on the ISI (score range, 0-28; scores ≥15 indicate moderate to severe insomnia). Secondary outcome was scores on the Pittsburgh Sleep Quality Index (score range, 0-21; higher scores indicate worse sleep quality). Additional outcomes included sleep and hot flash diary variables and hot flash interference. Results: At 8 weeks, ISI scores had decreased 9.9 points among 53 women receiving CBT-I (mean [SD] age, 55.0 [3.5] years) and 4.7 points among 53 women receiving MEC (age, 54.7 [4.7] years), a mean between-group difference of 5.2 points (95% CI, -6.1 to -3.3; P < .001). Pittsburgh Sleep Quality Index scores decreased 4.0 points in women receiving CBT-I and 1.4 points in women receiving MEC, a mean between-group difference of 2.7 points (95% CI, -3.9 to -1.5; P < .001). Significant group differences were sustained at 24 weeks. At 8 and 24 weeks, 33 of 47 women (70%) and 37 of 44 (84%) in the CBT-I group, respectively, had ISI scores in the no-insomnia range compared with 10 of 41 (24%) and 16 of 37 (43%) in the MEC group, respectively. The CBT-I group also had greater improvements in diary-reported sleep latency, wake time, and sleep efficiency. There were no between-group differences in frequency of daily hot flashes, but hot flash interference was significantly decreased at 8 weeks for the CBT-I group (-15.7; 95% CI, -20.4 to -11.0) compared with the MEC group (-7.1; 95% CI, -14.6 to 0.4) (P = .03), differences that were maintained at 24 weeks for the CBT-I group (-22.8; 95% CI, -28.6 to -16.9) and MEC group (-11.6; 95% CI, -19.4 to -3.8) (P = .003). Conclusions and relevance: Telephone-based CBT-I improved sleep in perimenopausal and postmenopausal women with insomnia and hot flashes. Results support further development and testing of centralized CBT-I programs for treating menopausal insomnia. Trial registration: clinicaltrials.gov Identifier: NCT01936441.

JAMA internal medicine · randomised controlled trial · 114 citationsread the source →

Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial.

Background: Long-term loss of arm function after ischaemic stroke is common and might be improved by vagus nerve stimulation paired with rehabilitation. We aimed to determine whether this strategy is a safe and effective treatment for improving arm function after stroke. Methods: In this pivotal, randomised, triple-blind, sham-controlled trial, done in 19 stroke rehabilitation services in the UK and the USA, participants with moderate-to-severe arm weakness, at least 9 months after ischaemic stroke, were randomly assigned (1:1) to either rehabilitation paired with active vagus nerve stimulation (VNS group) or rehabilitation paired with sham stimulation (control group). Randomisation was done by ResearchPoint Global (Austin, TX, USA) using SAS PROC PLAN (SAS Institute Software, Cary, NC, USA), with stratification by region (USA vs UK), age (≤30 years vs >30 years), and baseline Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score (20-35 vs 36-50). Participants, outcomes assessors, and treating therapists were masked to group assignment. All participants were implanted with a vagus nerve stimulation device. The VNS group received 0·8 mA, 100 μs, 30 Hz stimulation pulses, lasting 0·5 s. The control group received 0 mA pulses. Participants received 6 weeks of in-clinic therapy (three times per week; total of 18 sessions) followed by a home exercise programme. The primary outcome was the change in impairment measured by the FMA-UE score on the first day after completion of in-clinic therapy. FMA-UE response rates were also assessed at 90 days after in-clinic therapy (secondary endpoint). All analyses were by intention to treat. This trial is registered at ClinicalTrials.gov, NCT03131960. Findings: Between Oct 2, 2017, and Sept 12, 2019, 108 participants were randomly assigned to treatment (53 to the VNS group and 55 to the control group). 106 completed the study (one patient for each group did not complete the study). On the first day after completion of in-clinic therapy, the mean FMA-UE score increased by 5·0 points (SD 4·4) in the VNS group and by 2·4 points (3·8) in the control group (between group difference 2·6, 95% CI 1·0-4·2, p=0·0014). 90 days after in-clinic therapy, a clinically meaningful response on the FMA-UE score was achieved in 23 (47%) of 53 patients in the VNS group versus 13 (24%) of 55 patients in the control group (between group difference 24%, 6-41; p=0·0098). There was one serious adverse event related to surgery (vocal cord paresis) in the control group. Interpretation: Vagus nerve stimulation paired with rehabilitation is a novel potential treatment option for people with long-term moderate-to-severe arm impairment after ischaemic stroke. Funding: MicroTransponder.

Lancet (London, England) · randomised controlled trial · 397 citationsread the source →

Integrated Hepatitis C-Opioid Use Disorder Care Through Facilitated Telemedicine: A Randomized Trial.

Importance: Facilitated telemedicine may promote hepatitis C virus elimination by mitigating geographic and temporal barriers. Objective: To compare sustained virologic responses for hepatitis C virus among persons with opioid use disorder treated through facilitated telemedicine integrated into opioid treatment programs compared with off-site hepatitis specialist referral. Design, setting, and participants: Prospective, cluster randomized clinical trial using a stepped wedge design. Twelve programs throughout New York State included hepatitis C-infected participants (n = 602) enrolled between March 1, 2017, and February 29, 2020. Data were analyzed from December 1, 2022, through September 1, 2023. Intervention: Hepatitis C treatment with direct-acting antivirals through comanagement with a hepatitis specialist either through facilitated telemedicine integrated into opioid treatment programs (n = 290) or standard-of-care off-site referral (n = 312). Main outcomes and measures: The primary outcome was hepatitis C virus cure. Twelve programs began with off-site referral, and every 9 months, 4 randomly selected sites transitioned to facilitated telemedicine during 3 steps without participant crossover. Participants completed 2-year follow-up for reinfection assessment. Inclusion criteria required 6-month enrollment in opioid treatment and insurance coverage of hepatitis C medications. Generalized linear mixed-effects models were used to test for the intervention effect, adjusted for time, clustering, and effect modification in individual-based intention-to-treat analysis. Results: Among 602 participants, 369 were male (61.3%); 296 (49.2%) were American Indian or Alaska Native, Asian, Black or African American, multiracial, or other (ie, no race category was selected, with race data collected according to the 5 standard National Institutes of Health categories); and 306 (50.8%) were White. The mean (SD) age of the enrolled participants in the telemedicine group was 47.1 (13.1) years; that of the referral group was 48.9 (12.8) years. In telemedicine, 268 of 290 participants (92.4%) initiated treatment compared with 126 of 312 participants (40.4%) in referral. Intention-to-treat cure percentages were 90.3% (262 of 290) in telemedicine and 39.4% (123 of 312) in referral, with an estimated logarithmic odds ratio of the study group effect of 2.9 (95% CI, 2.0-3.5; P < .001) with no effect modification. Observed cure percentages were 246 of 290 participants (84.8%) in telemedicine vs 106 of 312 participants (34.0%) in referral. Subgroup effects were not significant, including fibrosis stage, urban or rural participant residence location, or mental health (anxiety or depression) comorbid conditions. Illicit drug use decreased significantly (referral: 95% CI, 1.2-4.8; P = .001; telemedicine: 95% CI, 0.3-1.0; P < .001) among cured participants. Minimal reinfections (n = 13) occurred, with hepatitis C virus reinfection incidence of 2.5 per 100 person-years. Participants in both groups rated health care delivery satisfaction as high or very high. Conclusions and relevance: Opioid treatment program-integrated facilitated telemedicine resulted in significantly higher hepatitis C virus cure rates compared with off-site referral, with high participant satisfaction. Illicit drug use declined significantly among cured participants with minimal reinfections. Trial registration: ClinicalTrials.gov Identifier: NCT02933970.

JAMA · randomised controlled trial · 49 citationsread the source →

Long-term developmental effects of withholding parenteral nutrition for 1 week in the paediatric intensive care unit: a 2-year follow-up of the PEPaNIC international, randomised, controlled trial.

Background: The paediatric early versus late parenteral nutrition in critical illness (PEPaNIC) multicentre, randomised, controlled trial showed that, compared with early parenteral nutrition, withholding supplemental parenteral nutrition for 1 week in the paediatric intensive care unit (PICU; late parenteral nutrition) reduced infections and accelerated recovery from critical illness in children. We aimed to investigate the long-term impact on physical and neurocognitive development of early versus late parenteral nutrition. Methods: In this preplanned 2-year follow-up study, all patients included in the PEPaNIC trial (which was done in University Hospitals Leuven, Belgium; Erasmus Medical Centre-Sophia Children's Hospital, Rotterdam, Netherlands; and Stollery Children's Hospital, Edmonton, AB, Canada) were approached for possible assessment of physical and neurocognitive development compared with healthy children who were matched for age and sex, and who had never been admitted to a neonatal ICU or a PICU. Assessed outcomes comprised anthropometric data; health status; parent-reported or caregiver-reported executive functions and emotional and behavioural problems; and tests for intelligence, visual-motor integration, alertness, motor coordination, inhibitory control, cognitive flexibility, and memory. To address partial responses among the children tested, we did multiple data imputation by chained equations before univariable and multivariable linear and logistic regression analyses adjusted for risk factors. This trial is registered with ClinicalTrials.gov, number NCT01536275. Findings: At the 2-year follow-up, 60 (8%) of 717 children who received late parenteral nutrition and 63 (9%) of 723 children who received early parenteral nutrition had died (p=0·81). 68 (9%) of 717 children who received late and 91 (13%) of 723 children who received early parenteral nutrition were too disabled for neurocognitive assessment (p=0·059), and 786 patients (395 assigned to late and 391 assigned to early parenteral nutrition) consented for testing. 786 patients and 405 healthy control children underwent long-term outcome testing between Aug 4, 2014, and Jan 19, 2018, and were included in the imputation model for subsequent multivariable analyses. Late parenteral nutrition did not adversely affect anthropometric data, health status, or neurological functioning, and improved parent-reported or caregiver-reported executive functioning (late vs early parenteral nutrition β estimate -2·258, 95% CI -4·012 to -0·504; p=0·011), more specifically inhibition (-3·422, -5·171 to -1·673; p=0·0001), working memory (-2·016, -3·761 to -0·270; p=0·023), and meta-cognition (-1·957, -3·694 to -0·220; p=0·027). Externalising behavioural problems (β estimate -1·715, 95% CI -3·325 to -0·106; p=0·036) and visual-motor integration (0·468, 0·087 to 0·850; p=0·016) were also improved in the late parenteral nutrition group compared with the early parenteral nutrition group. After Bonferroni correction for multiple comparisons, the effect on inhibitory control remained significant (p=0·0001). Interpretation: Withholding early parenteral nutrition for 1 week in the PICU did not negatively affect survival, anthropometrics, health status, and neurocognitive development, and improved inhibitory control 2 years after PICU admission. Funding: European Research Council Advanced Grant, Methusalem programme provided by the Flemish Government, Flemish Agency for Innovation by Science and Technology (IWT), Research Foundation Flanders (FWO), Sophia Children's Hospital Foundation (SSWO), Stichting Agis Zorginnovatie, Erasmus Trustfonds, and European Society for Parenteral and Enteral Nutrition (ESPEN) research grant.

The Lancet. Respiratory medicine · randomised controlled trial · 72 citationsread the source →

Mindfulness-based cognitive therapy for patients with chronic, treatment-resistant depression: A pragmatic randomized controlled trial.

Background: Chronic and treatment-resistant depressions pose serious problems in mental health care. Mindfulness-based cognitive therapy (MBCT) is an effective treatment for remitted and currently depressed patients. It is, however, unknown whether MBCT is effective for chronic, treatment-resistant depressed patients. Method: A pragmatic, multicenter, randomized-controlled trial was conducted comparing treatment-as-usual (TAU) with MBCT + TAU in 106 chronically depressed outpatients who previously received pharmacotherapy (≥4 weeks) and psychological treatment (≥10 sessions). Results: Based on the intention-to-treat (ITT) analysis, participants in the MBCT + TAU condition did not have significantly fewer depressive symptoms than those in the TAU condition (-3.23 [-6.99 to 0.54], d = 0.35, P = 0.09) at posttreatment. However, compared to TAU, the MBCT + TAU group reported significantly higher remission rates (χ2 (2) = 4.25, φ = 0.22, P = 0.04), lower levels of rumination (-3.85 [-7.55 to -0.15], d = 0.39, P = 0.04), a higher quality of life (4.42 [0.03-8.81], d = 0.42, P = 0.048), more mindfulness skills (11.25 [6.09-16.40], d = 0.73, P < 0.001), and more self-compassion (2.91 [1.17-4.65], d = 0.64, P = 0.001). The percentage of non-completers in the MBCT + TAU condition was relatively high (n = 12, 24.5%). Per-protocol analyses revealed that those who completed MBCT + TAU had significantly fewer depressive symptoms at posttreatment compared to participants receiving TAU (-4.24 [-8.38 to -0.11], d = 0.45, P = 0.04). Conclusion: Although the ITT analysis did not reveal a significant reduction in depressive symptoms of MBCT + TAU over TAU, MBCT + TAU seems to have beneficial effects for chronic, treatment-resistant depressed patients in terms of remission rates, rumination, quality of life, mindfulness skills, and self-compassion. Additionally, patients who completed MBCT showed significant reductions in depressive symptoms. Reasons for non-completion should be further investigated.

Depression and anxiety · randomised controlled trial · 78 citationsread the source →

Effect of Varenicline Combined With Medical Management on Alcohol Use Disorder With Comorbid Cigarette Smoking: A Randomized Clinical Trial.

Importance: Individuals with alcohol use disorder have high rates of cigarette smoking. Varenicline tartrate, an approved treatment for smoking cessation, may reduce both drinking and smoking. Objectives: To test the efficacy of varenicline with medical management for patients with alcohol use disorder and comorbid smoking seeking alcohol treatment, and to evaluate the secondary effects on smoking abstinence. Design, setting, and participants: This phase 2, randomized, double-blind, parallel group, placebo-controlled trial was conducted at 2 outpatient clinics from September 19, 2012, to August 31, 2015. Eligible participants met alcohol-dependence criteria and reported heavy drinking (≥5 drinks for men and ≥4 drinks for women) 2 or more times per week and smoking 2 or more times per week; 131 participants were randomized to either varenicline or placebo stratified by sex and site. All analyses were of the intention-to-treat type. Data analysis was conducted from February 5, 2016, to September 29, 2017. Interventions: Varenicline tartrate, 1 mg twice daily, and matching placebo pills for 16 weeks. Medical management emphasized medication adherence for 4 weeks followed by support for changing drinking. Main outcomes and measures: Percentage of heavy drinking days (PHDD) weeks 9 to 16, no heavy drinking days (NHDD) weeks 9 to 16, and prolonged smoking abstinence weeks 13 to 16. Results: Of 131 participants, 39 (29.8%) were women and 92 (70.2%) were men, the mean (SD) age was 42.7 (11.7) years, and the race/ethnicity self-identified by most respondents was black (69 [52.7%]). Sixty-four participants were randomized to receive varenicline, and 67 to receive placebo. Mean change in PHDD between varenicline and placebo across sex and site was not significantly different. However, a significant treatment by sex by time interaction for PHDD (F1,106 = 4.66; P = .03) revealed that varenicline compared with placebo resulted in a larger decrease in log-transformed PHDD in men (least square [LS] mean difference in change from baseline, 0.54; 95% CI, -0.09 to 1.18; P = .09; Cohen d = 0.45) but a smaller decrease in women (LS mean difference, -0.69; 95% CI, -1.63 to 0.25; P = .15; Cohen d = -0.53). Thirteen of 45 men (29%) had NHDD taking varenicline compared with 3 of 47 men (6%) taking placebo (Cohen h = 0.64; 95% CI, 0.22-1.03), whereas 1 of 19 women (5%) had NHDD compared with 5 of 20 women (25%) taking placebo (Cohen h = -0.60; 95% CI, -1.21 to 0.04). Taking varenicline, 8 of 64 participants (13%) achieved prolonged smoking abstinence; no one (0 of 67) quit smoking taking placebo (P = .003; Cohen h = 0.72; 95% CI, 0.38-1.07). Conclusions and relevance: Varenicline with medical management resulted in decreased heavy drinking among men and increased smoking abstinence in the overall sample. Varenicline could be considered to promote improvements in men with these dual behavioral health risks. Trial registration: clinicaltrials.gov Identifier: NCT01553136.

JAMA psychiatry · randomised controlled trial · 77 citationsread the source →

Early intervention for psychosis.

Background: Proponents of early intervention have argued that outcomes might be improved if more therapeutic efforts were focused on the early stages of schizophrenia or on people with prodromal symptoms. Early intervention in schizophrenia has two elements that are distinct from standard care: early detection, and phase-specific treatment (phase-specific treatment is a psychological, social or physical treatment developed, or modified, specifically for use with people at an early stage of the illness).Early detection and phase-specific treatment may both be offered as supplements to standard care, or may be provided through a specialised early intervention team. Early intervention is now well established as a therapeutic approach in America, Europe and Australasia. Objectives: To evaluate the effects of: (a) early detection; (b) phase-specific treatments; and (c) specialised early intervention teams in the treatment of people with prodromal symptoms or first-episode psychosis. Search strategy: We searched the Cochrane Schizophrenia Group Trials Register (March 2009), inspected reference lists of all identified trials and reviews and contacted experts in the field. Selection criteria: We included all randomised controlled trials (RCTs) designed to prevent progression to psychosis in people showing prodromal symptoms, or to improve outcome for people with first-episode psychosis. Eligible interventions, alone and in combination, included: early detection, phase-specific treatments, and care from specialised early intervention teams. We accepted cluster-randomised trials but excluded non-randomised trials. Data collection and analysis: We reliably selected studies, quality rated them and extracted data. For dichotomous data, we estimated relative risks (RR), with the 95% confidence intervals (CI). Where possible, we calculated the number needed to treat/harm statistic (NNT/H) and used intention-to-treat analysis (ITT). Main results: Studies were diverse, mostly small, undertaken by pioneering researchers and with many methodological limitations (18 RCTs, total n=1808). Mostly, meta-analyses were inappropriate. For the six studies addressing prevention of psychosis for people with prodromal symptoms, olanzapine seemed of little benefit (n=60, 1 RCT, RR conversion to psychosis 0.58 CI 0.3 to 1.2), and cognitive behavioural therapy (CBT) equally so (n=60, 1 RCT, RR conversion to psychosis 0.50 CI 0.2 to 1.7). A risperidone plus CBT plus specialised team did have benefit over specialist team alone at six months (n=59, 1 RCT, RR conversion to psychosis 0.27 CI 0.1 to 0.9, NNT 4 CI 2 to 20), but this was not seen by 12 months (n=59, 1 RCT, RR 0.54 CI 0.2 to 1.3). Omega 3 fatty acids (EPA) had advantage over placebo (n=76, 1 RCT, RR transition to psychosis 0.13 CI 0.02 to 1.0, NNT 6 CI 5 to 96). We know of no replications of this finding. The remaining trials aimed to improve outcome in first-episode psychosis. Phase-specific CBT for suicidality seemed to have little effect, but the single study was small (n=56, 1 RCT, RR suicide 0.81 CI 0.05 to 12.26). Family therapy plus a specialised team in the Netherlands did not clearly affect relapse (n=76, RR 1.05 CI 0.4 to 3.0), but without the specialised team in China it may (n=83, 1 RCT, RR admitted to hospital 0.28 CI 0.1 to 0.6, NNT 3 CI 2 to 6). The largest and highest quality study compared specialised team with standard care. Leaving the study early was reduced (n=547, 1 RCT, RR 0.59 CI 0.4 to 0.8, NNT 9 CI 6 to 18) and compliance with treatment improved (n=507, RR stopped treatment 0.20 CI 0.1 to 0.4, NNT 9 CI 8 to 12). The mean number of days spent in hospital at one year were not significantly different (n=507, WMD, -1.39 CI -2.8 to 0.1), neither were data for 'Not hospitalised' by five years (n=547, RR 1.05 CI 0.90 to 1.2). There were no significant differences in numbers 'not living independently' by one year (n=507, RR 0.55 CI 0.3 to 1.2). At five years significantly fewer participants in the treatment group were 'not living independently' (n=547, RR 0.42 CI 0.21 to 0.8, NNT 19 CI 14 to 62). When phase-specific treatment (CBT) was compared with befriending no significant differences emerged in the number of participants being hospitalised over the 12 months (n=62, 1 RCT, RR 1.08 CI 0.59 to 1.99).Phase-specific treatment E-EPA oils suggested no benefit (n=80, 1 RCT, RR no response 0.90 CI 0.6 to 1.4) as did phase-specific treatment brief intervention (n=106, 1 RCT, RR admission 0.86 CI 0.4 to 1.7). Phase-specific ACE found no benefit but participants given vocational intervention were more likely to be employed (n=41, 1 RCT, RR 0.39 CI 0.21 to 0.7, NNT 2 CI 2 to 4). Phase-specific cannabis and psychosis therapy did not show benefit (n=47, RR cannabis use 1.30 CI 0.8 to 2.2) and crisis assessment did not reduce hospitalisation (n=98, RR 0.85 CI 0.6 to 1.3). Weight was unaffected by early behavioural intervention. Authors' conclusions: There is emerging, but as yet inconclusive evidence, to suggest that people in the prodrome of psychosis can be helped by some interventions. There is some support for specialised early intervention services, but further trials would be desirable, and there is a question of whether gains are maintained. There is some support for phase-specific treatment focused on employment and family therapy, but again, this needs replicating with larger and longer trials.

The Cochrane database of systematic reviews · meta-analysis · 133 citationsread the source →

Omega-3 fatty acids, oxidative stress, and leukocyte telomere length: A randomized controlled trial.

Shorter telomeres have been associated with poor health behaviors, age-related diseases, and early mortality. Telomere length is regulated by the enzyme telomerase, and is linked to exposure to proinflammatory cytokines and oxidative stress. In our recent randomized controlled trial, omega-3 (n-3) polyunsaturated fatty acid (PUFA) supplementation lowered the concentration of serum proinflammatory cytokines. This study assessed whether n-3 PUFA supplementation also affected leukocyte telomere length, telomerase, and oxidative stress. In addition to testing for group differences, changes in the continuous n-6:n-3 PUFA ratio were assessed to account for individual differences in adherence, absorption, and metabolism. The double-blind four-month trial included 106 healthy sedentary overweight middle-aged and older adults who received (1) 2.5g/day n-3 PUFAs, (2) l.25g/day n-3 PUFAs, or (3) placebo capsules that mirrored the proportions of fatty acids in the typical American diet. Supplementation significantly lowered oxidative stress as measured by F2-isoprostanes (p=0.02). The estimated geometric mean log-F2-isoprostanes values were 15% lower in the two supplemented groups compared to placebo. Although group differences for telomerase and telomere length were nonsignificant, changes in the n-6:n-3 PUFA plasma ratios helped clarify the intervention's impact: telomere length increased with decreasing n-6:n-3 ratios, p=0.02. The data suggest that lower n-6:n-3 PUFA ratios can impact cell aging. The triad of inflammation, oxidative stress, and immune cell aging represents important pre-disease mechanisms that may be ameliorated through nutritional interventions. This translational research broadens our understanding of the potential impact of the n-6:n-3 PUFA balance. ClinicalTrials.gov identifier: NCT00385723.

Brain, behavior, and immunity · randomised controlled trial · 180 citationsread the source →

Preventive care at home for very preterm infants improves infant and caregiver outcomes at 2 years.

Objective: The objective of this study was to determine the effects of preventive care at home on child development and primary caregiver mental health at 2 years of age. Methods: A total of 120 very preterm infants (<30 weeks) were assigned randomly to intervention (n = 61) or control (n = 59) groups. The intervention group received the preventive care program (9 home visits over the first year from a physiotherapist and a psychologist, focusing on the parent-infant relationship, the parents' mental health, and the infant's development); and the control group received standard care. At corrected age of 2 years, developmental outcomes were assessed, and primary caregivers completed the Infant-Toddler Social and Emotional Assessment. The mental health of the primary caregivers was assessed with the Hospital Anxiety and Depression Scale. Results: At 2 years of age, 115 children (96%) were assessed with the Bayley Scales of Infant and Toddler Development III and 100 children (83%) with the Infant-Toddler Social and Emotional Assessment; and 91 (86%) of 106 caregivers completed the Hospital Anxiety and Depression Scale. There were no statistically significant differences in cognitive, language, or motor composite scores between the treatment groups. However, children in the intervention group were reported by their primary caregivers to exhibit less externalizing and dysregulation behaviors and increased competence, compared with control subjects. Primary caregivers in the intervention group reported less anxiety and depression. Conclusion: A preventive care program for very preterm infants and their families improved behavioral outcomes for infants and reduced anxiety and depression for primary caregivers.

Pediatrics · randomised controlled trial · 87 citationsread the source →

Video decision support tool for advance care planning in dementia: randomised controlled trial.

Objective: To evaluate the effect of a video decision support tool on the preferences for future medical care in older people if they develop advanced dementia, and the stability of those preferences after six weeks. Design: Randomised controlled trial conducted between 1 September 2007 and 30 May 2008. Setting Four primary care clinics (two geriatric and two adult medicine) affiliated with three academic medical centres in Boston. Participants: Convenience sample of 200 older people (>or=65 years) living in the community with previously scheduled appointments at one of the clinics. Mean age was 75 and 58% were women. Intervention: Verbal narrative alone (n=106) or with a video decision support tool (n=94). Main outcome measures: Preferred goal of care: life prolonging care (cardiopulmonary resuscitation, mechanical ventilation), limited care (admission to hospital, antibiotics, but not cardiopulmonary resuscitation), or comfort care (treatment only to relieve symptoms). Preferences after six weeks. The principal category for analysis was the difference in proportions of participants in each group who preferred comfort care. Results: Among participants receiving the verbal narrative alone, 68 (64%) chose comfort care, 20 (19%) chose limited care, 15 (14%) chose life prolonging care, and three (3%) were uncertain. In the video group, 81 (86%) chose comfort care, eight (9%) chose limited care, four (4%) chose life prolonging care, and one (1%) was uncertain (chi(2)=13.0, df=3, P=0.003). Among all participants the factors associated with a greater likelihood of opting for comfort care were being a college graduate or higher, good or better health status, greater health literacy, white race, and randomisation to the video arm. In multivariable analysis, participants in the video group were more likely to prefer comfort care than those in the verbal group (adjusted odds ratio 3.9, 95% confidence interval 1.8 to 8.6). Participants were re-interviewed after six weeks. Among the 94/106 (89%) participants re-interviewed in the verbal group, 27 (29%) changed their preferences (kappa=0.35). Among the 84/94 (89%) participants re-interviewed in the video group, five (6%) changed their preferences (kappa=0.79) (P<0.001 for difference). Conclusion: Older people who view a video depiction of a patient with advanced dementia after hearing a verbal description of the condition are more likely to opt for comfort as their goal of care compared with those who solely listen to a verbal description. They also have more stable preferences over time. Trial registration: Clinicaltrials.gov NCT00704886.

BMJ (Clinical research ed.) · randomised controlled trial · 207 citationsread the source →

Mediating effects of group cohesion on physical activity and diet in women of color: health is power.

Purpose: To determine the effects and mediating factors of a physical activity (PA) or vegetable and fruit (VF) group cohesion intervention. Design: Longitudinal design. Setting: Harris County and Travis County, Texas. Participants: Community-dwelling African-American and Hispanic or Latina women. Intervention: Three hundred ten women were randomized to a PA (n  =  204) or VF (n  =  106) intervention group. Women met in groups six times over the course of 6 months and were exposed to a group cohesion intervention to promote walking or to increase VF consumption. Measures: Women completed the International PA Questionnaire, National Cancer Institute VF and fat screeners, PA Group Environment Questionnaire, and 7-day accelerometer protocol at baseline and post-intervention. Analyses: The direct and mediated effects of the intervention on outcomes were evaluated using a mediational chain model, controlling for baseline values and covariates using path analysis. Results: Women were middle aged (mean  =  44.4 years) and overweight or obese (mean body mass index  =  34.0 kg/m(2)). PA increased and fat consumption decreased for both groups, whereas VF consumption increased for women in VF group only (all p < .05). Increased task cohesion led to hypothesized increases in psychosocial factors in the PA group but not to behavioral changes. Conclusions: Group cohesion interventions may have psychological and physical health benefits for African-American and Hispanic or Latina women, but refinement of measures and intervention delivery is needed to determine whether hypothesized mediational pathways are valid.

American journal of health promotion : AJHP · randomised controlled trial · 37 citationsread the source →

Effect of COVID-19 vaccination and booster on maternal-fetal outcomes: a retrospective cohort study.

Background: COVID-19 in pregnant people increases the risk for poor maternal-fetal outcomes. However, COVID-19 vaccination hesitancy remains due to concerns over the vaccine's potential effects on maternal-fetal outcomes. Here we examine the impact of COVID-19 vaccination and boosters on maternal SARS-CoV-2 infections and birth outcomes. Methods: This was a retrospective multicentre cohort study on the impact of COVID-19 vaccination on maternal-fetal outcomes for people who delivered (n=106 428) at Providence St Joseph Health across seven western US states from Jan 26, 2021 to Oct 26, 2022. Cohorts were defined by vaccination status at delivery: vaccinated (n=35 926; two or more doses of mRNA-1273 Moderna or BNT162b2 Pfizer-BioNTech), unvaccinated (n=55 878), unvaccinated propensity score matched (n=16 771), boosted (n=10 927; three or more doses), vaccinated unboosted (n=13 243; two doses only), and vaccinated unboosted with propensity score matching (n=4414). We built supervised machine learning classification models, which we used to determine which people were more likely to be vaccinated or boosted at delivery. The primary outcome was maternal SARS-CoV-2 infection. COVID-19 vaccination status at delivery, COVID-19-related health care, preterm birth, stillbirth, and very low birthweight were evaluated as secondary outcomes. Findings: Vaccinated people were more likely to conceive later in the pandemic, have commercial insurance, be older, live in areas with lower household composition vulnerability, and have a higher BMI than unvaccinated people. Boosted people were more likely to have more days since receiving the second COVID-19 vaccine dose, conceive earlier in the pandemic, have commercial insurance, be older, and live in areas with lower household composition vulnerability than vaccinated unboosted people. Vaccinated pregnant people had lower rates of COVID-19 during pregnancy (4·0%) compared with unvaccinated matched people (5·3%; p<0·0001). COVID-19 rates were even lower in boosted people (3·2%) compared with vaccinated unboosted matched people (5·6%; p<0·0001). Vaccinated people were also less likely to have a preterm birth (7·9%; p<0·0001), stillbirth (0·3%; p<0·0002), or very low birthweight neonate (1·0%; p<0·0001) compared with unvaccinated matched people (preterm birth 9·4%; stillbirth 0·6%; very low birthweight 1·5%). Boosted people were less likely to have a stillbirth (0·3%; p<0·025) and have no differences in rates of preterm birth (7·6%; p=0·090) or very low birthweight neonates (0·8%; p=0·092) compared with vaccinated unboosted matched people (stillbirth 0·5%; preterm birth 8·4%; very low birthweight 1·1%). Interpretation: COVID-19 vaccination protects against adverse maternal-fetal outcomes, with booster doses conferring additional protection. Pregnant people should be high priority for vaccination and stay up to date with their COVID-19 vaccination schedule. Funding: National Institute for Child Health & Human Development and the William O and K Carole Ellison Foundation.

The Lancet. Digital health · cohort or longitudinal · 34 citationsread the source →

Development and validation of the Short Professional Quality of Life Scale based on versions IV and V of the Professional Quality of Life Scale.

Background: This research presents a short version of the Professional Quality of Life (ProQOL) scale, one of the most frequently used questionnaires in the arena of applied healthcare investigation. It measures burnout (BO), compassion fatigue (CF), and compassion satisfaction (CS). Methods: A 9-item version of the ProQOL was developed. In Study 1, this short version, which used items from version IV of the ProQOL, was administered to 817 palliative care professionals from Spain, Argentina, and Brazil. In Study 2, the same nine items, but this time from version V of the ProQOL, were administered to 296 Spanish palliative care professionals. Results: Study 1: The Short ProQOL showed an adequate internal structure, and invariance across the countries studied (χ2(106) = 185.620 (p < 0.001), CFI = .929, RMSEA = 0.058 [0.044, 0.072], SRMR = 0.081). Argentinians showed higher levels of BO (mean difference = 0.172, p = 0.042, Cohen's d = 0.168), whereas Brazilians showed higher levels of CF (Mean difference = 0.384, p = 0.002, Cohen's d = 0.352). Study 2: the Short ProQOL again showed adequate internal structure and reliability (χ2(24) = 134.504 (p < 0.001); CFI = 0.953; RMSEA = 0.126 [0.106, 0.147]; SRMR = 0.063), and was related to coping with death, self-compassion, and self-care. Conclusions: The Short ProQOL could help facilitate the application of harmonizing measurements and its use for cross-cultural comparisons and occupational health monitoring was satisfactory.

Health and quality of life outcomes · cohort or longitudinal · 40 citationsread the source →

A longitudinal, observational study of the features of transitional healthcare associated with better outcomes for young people with long-term conditions.

Background: Most evidence about what works in transitional care comes from small studies in single clinical specialties. We tested the hypothesis that exposures to nine recommended features of transitional healthcare were associated with better outcomes for young people with long-term conditions during transition from child-centred to adult-oriented health services. Methods: This is a longitudinal, observational cohort study in UK secondary care including 374 young people, aged 14-18.9 years at recruitment, with type 1 diabetes (n = 150), cerebral palsy (n = 106) or autism spectrum disorder with an associated mental health problem (n = 118). All were pre-transfer and without significant learning disability. We approached all young people attending five paediatric diabetes centres, all young people with autism spectrum disorder attending four mental health centres, and randomly selected young people from two population-based cerebral palsy registers. Participants received four home research visits, 1 year apart and 274 participants (73%) completed follow-up. Outcome measures were Warwick Edinburgh Mental Wellbeing Scale, Mind the Gap Scale (satisfaction with services), Rotterdam Transition Profile (Participation) and Autonomy in Appointments. Results: Exposure to recommended features was 61% for 'coordinated team', 53% for 'age-banded clinic', 48% for 'holistic life-skills training', 42% for 'promotion of health self-efficacy', 40% for 'meeting the adult team before transfer', 34% for 'appropriate parent involvement' and less than 30% for 'written transition plan', 'key worker' and 'transition manager for clinical team'. Three features were strongly associated with improved outcomes. (1) 'Appropriate parent involvement', example association with Wellbeing (b = 4.5, 95% CI 2.0-7.0, p = 0.001); (2) 'Promotion of health self-efficacy', example association with Satisfaction with Services (b = - 0.5, 95% CI - 0.9 to - 0.2, p = 0.006); (3) 'Meeting the adult team before transfer', example associations with Participation (arranging services and aids) (odds ratio 5.2, 95% CI 2.1-12.8, p < 0.001) and with Autonomy in Appointments (average 1.7 points higher, 95% CI 0.8-2.6, p < 0.001). There was slightly less recruitment of participants from areas with greater socioeconomic deprivation, though not with respect to family composition. Conclusions: Three features of transitional care were associated with improved outcomes. Results are likely to be generalisable because participants had three very different conditions, attending services at many UK sites. Results are relevant for clinicians as well as for commissioners and managers of health services. The challenge of introducing these three features across child and adult healthcare services, and the effects of doing so, should be assessed.

BMC medicine · cohort or longitudinal · 94 citationsread the source →

Reference equations for the six-minute walk distance based on a Brazilian multicenter study.

Background: It is important to include large sample sizes and different factors that influence the six-minute walking distance (6MWD) in order to propose reference equations for the six-minute walking test (6 MWT). Objective: To evaluate the influence of anthropometric, demographic, and physiologic variables on the 6 MWD of healthy subjects from different regions of Brazil to establish a reference equation for the Brazilian population. Method: In a multicenter study, 617 healthy subjects performed two 6 MWTs and had their weight, height, and body mass index (BMI) measured, as well as their physiologic responses to the test. Delta heart rate (∆HR), perceived effort, and peripheral oxygen saturation were calculated by the difference between the respective values at the end of the test minus the baseline value. Results: Walking distance averaged 586 ± 106 m, 54 m greater in male compared to female subjects (p<0.001). No differences were observed among the 6 MWD from different regions. The quadratic regression analysis considering only anthropometric and demographic data explained 46% of the variability in the 6 MWT (p<0.001) and derived the equation: 6 MWD(pred)=890.46-(6.11 × age)+(0.0345 × age(2))+(48.87 × gender)-(4.87 × BMI). A second model of stepwise multiple regression including ∆HR explained 62% of the variability (p<0.0001) and derived the equation: 6 MWD(pred)=356.658-(2.303 × age)+(36.648 × gender)+(1.704 × height)+(1.365×∆HR). Conclusion: The equations proposed in this study, especially the second one, seem adequate to accurately predict the 6 MWD for Brazilians.

Brazilian journal of physical therapy · cohort or longitudinal · 166 citationsread the source →

The assessment of generalized anxiety disorder: psychometric validation of the Spanish version of the self-administered GAD-2 scale in daily medical practice.

Aim: To psychometrically validate the Spanish version of the self-administered 2-item GAD-2 scale for screening probable patients with generalised anxiety disorder (GAD). Methods: The GAD-2 was self-administered by patients diagnosed with GAD according to DSM-IV criteria and by age- and sex-matched controls who were recruited at random in mental health and primary care centres. Criteria validity was explored using ROC curve analysis, and sensitivity, specificity and positive and negative predictive values were determined for different cut-off values. Concurrent validity was also established using the HAM-A, HADS, and WHODAS II scales. Results: The study sample consisted of 212 subjects (106 patients with GAD) with a mean age of 50.38 years (SD = 16.76). No items of the scale were left blank. Floor and ceiling effects were negligible. No patients with GAD had to be assisted to complete the questionnaire. Reliability (internal consistency) was high; Cronbach's α = 0.875. A cut-off point of 3 showed adequate sensitivity (91.5%) and specificity (85.8%), with a statistically significant area under the curve (AUC = 0.937, p < 0.001), to distinguish GAD patients from controls. Concurrent validity was also high and significant with HAM-A (0.806, p < 0.001), HADS (anxiety domain, 0.825, p < 0.001) and WHO-DAS II (0.642, p < 0.001) scales. Conclusion: The Spanish version of the GAD-2 scale has been shown to have appropriate psychometric properties to rapidly detect probable cases of GAD in the Spanish cultural context under routine clinical practice conditions.

Health and quality of life outcomes · cohort or longitudinal · 65 citationsread the source →

Incidence and prevalence rates of diabetes mellitus in Saudi Arabia: An overview.

Objective: This study aimed to report on the trends in incidence and prevalence rates of diabetes mellitus in Saudi Arabia over the last 25 years (1990-2015). Design: A descriptive review. Methods: A systematic search was conducted for English-language, peer reviewed publications of any research design via Medline, EBSCO, PubMed and Scopus from 1990 to 2015. Of 106 articles retrieved, after removal of duplicates and quality appraisal, 8 studies were included in the review and synthesised based on study characteristics, design and findings. Findings: Studies originated from Saudi Arabia and applied a variety of research designs and tools to diagnosis diabetes. Of the 8 included studies; three reported type 1 diabetes and five on type 2 diabetes. Overall, findings indicated that the incidence and prevalence rate of diabetes is rising particularly among females, older children/adolescent and in urban areas. Conclusion: Further development are required to assess the health intervention, polices, guidelines, self-management programs in Saudi Arabia.

Journal of epidemiology and global health · review · 198 citationsread the source →

I fear your envy, I rejoice in your coveting: on the ambivalent experience of being envied by others.

We present 2 studies on being envied. Study 1 used an emotional narrative methodology. We asked 44 Spanish (23 women, 21 men) and 48 European American (36 women, 12 men) participants to tell us about a recent experience in which others envied them. We classified the antecedents, relationship context, markers of envy, coping strategies, and positive and negative implications of being envied. In Study 2, 174 Spanish (88 women, 86 men) and 205 European American (106 women, 99 men) participants responded to a situation in which they had something someone else wanted. We manipulated the object of desire (academic achievement or having "a better life"). We measured individual differences in orientation to achievement (i.e., vertical individualism), cooperation and interpersonal harmony (i.e., horizontal collectivism), a zero-sum view of success, beliefs that success begets hostile coveting, fear of success, and dispositional envy. We also measured participants' appraisals, positive and negative emotions, and coping strategies. The findings from both studies indicate that being envied has both positive (e.g., increased self-confidence) and negative consequences (e.g., fear of ill will from others). Being envied had more positive and more negative psychological and relational consequences among those participants who were achievement oriented (European Americans) than among participants who were oriented to cooperation and interpersonal harmony (Spanish).

Journal of personality and social psychology · 9 citationsread the source →

The pleasure of art as a matter of fact

You have accessMoreSectionsView PDF ToolsAdd to favoritesDownload CitationsTrack Citations ShareShare onFacebookTwitterLinked InRedditEmail Cite this article Nadal Marcos and Skov Martin 2018The pleasure of art as a matter of factProc. R. Soc. B.2852017225220172252http://doi.org/10.1098/rspb.2017.2252SectionYou have accessCommentThe pleasure of art as a matter of fact Marcos Nadal Marcos Nadal http://orcid.org/0000-0002-9341-4688 Department of Psychology, University of the Balearic Islands, Palma de Mallorca 07122, Spain [email protected] Google Scholar Find this author on PubMed Search for more papers by this author and Martin Skov Martin Skov Danish Research Centre for Magnetic Resonance, Copenhagen University Hospital Hvidovre, Copenhagen 2650, Denmark Center for Decision Neuroscience, Copenhagen Business School, Copenhagen 2000, Denmark Google Scholar Find this author on PubMed Search for more papers by this author Marcos Nadal Marcos Nadal http://orcid.org/0000-0002-9341-4688 Department of Psychology, University of the Balearic Islands, Palma de Mallorca 07122, Spain [email protected] Google Scholar Find this author on PubMed and Martin Skov Martin Skov Danish Research Centre for Magnetic Resonance, Copenhagen University Hospital Hvidovre, Copenhagen 2650, Denmark Center for Decision Neuroscience, Copenhagen Business School, Copenhagen 2000, Denmark Google Scholar Find this author on PubMed Published:21 March 2018https://doi.org/10.1098/rspb.2017.2252All other forms of perception divide a man, because they are exclusively based either on the sensuous or on the intellectual part of his being; only the perception of the Beautiful makes something whole of him, because both his natures must accord with it.— Schiller, 1793–1795, Letters on the Aesthetic Education of Man, p. 138, Letter 27Can art make us better people? Better members of society? In her recent article, 'Pleasure junkies all around! Why it matters and why "the arts" might be the answer: a biopsychological perspective', Christensen [1] claims that engaging with art can promote healthy choices, choices that balance short-term pleasure goals with long-term general well-being. She suggests that many modern life conveniences, such as social media, computer games or online shopping, have the potential to turn us into 'pleasure junkies' because they maximize short-term pleasures. But art, Christensen argues, is a safe choice and a means to remedy this unhealthy addiction to pleasure. Christensen's argument is grounded on three claims about the sort of pleasure we get from art. First, in contrast to low-level pleasure, which Christensen conceives as 'a mere perceptual stimulation leading to a rewarding sensation (food, sex, etc.)' ([1], p. 2), pleasure from art is presented as a kind of higher-order pleasure that engages 'broader neural networks implied in the attribution of meaning' (p. 2), presumably leading to 'long-term maintenance of healthy bodily function' (p. 2). Second, 'the arts do not induce states of craving without fulfilment—as do activities with reinforcement schedules which are prone to create habits and addictions such as intermittent variable ratio or interval reinforcement schedules (e.g. social media, gambling, football, extreme sports, drugs' (p. 4). Third, 'the arts do not search for a perceptual "Bliss point" […]. They do not just repeat over and over again a sensory stimulus that excites the senses and induces craving for more of a "pleasurable itch" (e.g. sugar, sexualized body displays, certain musical lyrics, tones; i.e. a perceptual "bliss point")' (p. 4).The claim, in a nutshell, is that the pleasure induced by art is different to the pleasure induced by food, sex, sports or drugs, because it is related to the balanced activation of brain systems related to short-term pleasure and long-term wellbeing goals, because it does not induce craving, and because it is not aimed at a perceptual 'bliss point'. This distinct sort of pleasure, according to Christensen, makes it possible for the arts to thwart the pernicious effects that the unhealthy urges and cravings licensed by 'today's mainstream acceptance of pleasure-seeking behaviour' (p. 5) have on individuals' lives and on societies. Such sweeping statements about art, food, sex, sports and society as a whole merit close examination. Christensen's primary claim that the pleasure induced by art is of a special kind, different to the pleasure induced by other activities is not supported by current understanding of what pleasure is. It is, moreover, contradicted by abundant empirical evidence. This evidence shows that pleasures, whatever their source, owe to activity in the same mesocorticolimbic circuit [2] and are encoded as a common neural currency [3]. As Kent Berridge and Morten Kringelbach put it: 'the brain mechanisms involved in fundamental pleasures (food and sexual pleasures) overlap with those for higher-order pleasures (e.g. monetary, artistic, musical, altruistic and transcendent pleasures) […] From sensory pleasures and drugs of abuse […] to monetary, aesthetic and musical delights, all pleasures seem to involve the same hedonic brain systems' ([4], p. 481). Thus, there is no evidence for specific brain regions or neural circuits related to the pleasure from art. Rather, the appreciation of art relies on brain mechanisms that evolved to appraise the value of biologically relevant objects in relation to internal homeostatic states [5]: 'Emotional reactions to music, further, activate the same cortical, subcortical and autonomic circuits, which are considered as the essential survival circuits of biological organisms in general' ([6], p. 6). In sum, the evidence shows that pleasure elicited by music and other art forms is no different in genesis and function to the pleasure induced by food, drugs and sex [7,8]. This is a matter of fact, not opinion. What supports Christensen's argument if not empirical evidence? In our view, her argument for the distinctness of art-induced pleasure seems based upon an oversimplified and devaluing conception of the pleasures of sex, food and sports, and a very narrow notion of art and its function. Christensen presents food, sex and sports as meaningless low-level sources of pleasure, and the arts as privileged vehicles for meaningful experiences. It is the personal and meaningful engagement with art—Christensen suggests—that fosters a balanced activation of brain systems related to short-term pleasure and long-term well-being goals. However, rarely—if ever—are food, sex and sports meaningless rewarding sensations. Contrary to Christensen's definition on page 2 of her article, pleasure—even sensory pleasure—is not simply reward, and never simply a sensation [4]. Indulging in food, sex or sports are meaningful and personally significant experiences that are not a matter of mere physical sensation. The experience of pleasure from food and sex is shaped by context, knowledge, expectations, anticipations, attitudes and beliefs that bring meaning to them [9–11]. Sex can be meaningful because it signifies physical connection with one's loved one, because it is cheating on someone, or deemed a sin. Likewise, eating is not about obtaining low-level pleasure. What we eat, the way we eat, what we believe about what we eat, where and whom we eat with, imbue eating with individual and social meaning, and shape the actual pleasure of eating [12]. On the other hand, encounters with art are not necessarily meaningful [13,14]. Actually, there is nothing intrinsically meaningful about engaging with art. Many laypeople lack the knowledge schemata required to engage meaningfully with abstract, cubist or contemporary art [15,16]. There are plenty of artworks people do not find meaningful or pleasant. Meaning making is not a special feature of art; it is a general feature of our species's cognition [17,18]. We can endow virtually any aspect of reality with meaning: sex, food, sports, a urinal, the shape of a cloud, an averted glance, someone's absence. Christensen's argument also rests on a historically and culturally narrow conception of art and its function. Art is presented as a circumscribed category of activities that elicit a unique sort of pleasant experiences: — The arts are set of activities of a special kind that share certain defining features distinguishing them from other activities: 'the arts push boundaries, surprise, reveal and excite both artist and spectator' ([1], p. 4).— Art encounters are positive, leading to 'pleasurable chills' and pleasurable experiences of understanding: 'The moment of meaning-assignation, also called "mastering" or "understanding" an artwork, is therefore a pleasurable experience' ([1], p. 4).— The pleasure elicited by art is special, because it does not involve craving for intense peaks: 'The arts do not search for a perceptual "bliss point" […] They do not just repeat over and over a sensory stimulus that excites the senses and induces craving for more of a "pleasurable itch"' ([1], p. 4).This characterization of the arts substantially overlaps with the notion of 'fine arts'. The core features of this characterization were instituted in the eighteenth century, after European intellectuals grouped certain activities into a distinct and autonomous collection, labelled 'fine arts'. To make sense of and promote this grouping, it became imperative to identify a common essence setting art apart from other activities [19,20,21]. One of the most popular proposals was that only art could produce a special sort of pleasure, sophisticated and polite [19,21]—a conception stemming not from any understanding of physiology, but from mere speculation. This limited historical and cultural scope renders this conception of the arts unfit for behavioural or neuroscientific research [19]. The category 'the arts' should not be mistaken for a natural kind. It is a historical convention, and has no direct biological correspondence. Moreover, this conception of art that Christensen espouses does not apply to art as practised in non-Western societies [19,22]. It does not even apply to Western art before the eighteenth century or after the nineteenth century [19,20,21]. First, art does not necessarily evoke pleasurable experiences. There are abundant artworks intended to arouse negative emotions [19,23], and to portray physical and moral ugliness [24]. Understanding art is not necessarily a pleasant experience: it can be an angering, disgusting or upsetting one [25]. Second, many artworks actually exploit repetition, bliss points and craving [26]. Repetition is a fundamental design feature of music and other performance arts [27]: In Relation in Space (1976) Marina Abramovic and Ulay ran into each other repeatedly for an hour; Ravel's Bolero is a 17 min-long instance of melodic and rhythmic repetitiveness. Anticipation and craving for bliss points are also essential to music [28]. In fact, the enjoyment of music is linked to intense feelings of anticipation and expectation caused by dopamine activity in the caudate nucleus (also involved in the rewarding aspect of food) [29,30], and peak pleasure states (bliss points) [31], caused by the release of dopamine and opioids in the brain's reward system (also involved in cocaine induced euphoria) [29,30]. Given the available evidence, therefore, there is no reason to believe that the pleasure from art is special or unique [32].In sum, Christensen's claim for the distinctiveness of pleasure from art is contradicted by empirical evidence, and her argument for the beneficial effects of art rests upon disputed foundations. Art's capacity to promote healthier choices and make us better people that can contribute to a better society remains as unconfirmed today as it was when Schiller speculated on art's power to harmonize human's conflicting sensuous and formal impulses. Christensen's argument is problematic even if intended to highlight hypothetical possibilities. Arguments about hypothetical possibilities should still rely on valid premises, and scientific hypotheses should be grounded on evidence, or at least in line with it. Otherwise, they are merely unfounded speculations. Scientific aesthetics is only just finding its footing and its place within cognitive neuroscience [33,34]. If evidence is ignored or rejected because it does not fit preconceived notions about art and its function, scientific aesthetics will become only an arena to promote and legitimize personally appealing notions of art by applying a scientific gloss over them. A proper scientific study of art needs to be grounded on empirical evidence and strong arguments that follow from solid premises [35,36]. 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(doi:10.1016/j.plrev.2017.06.013) PubMed, ISI, Google Scholar Previous ArticleNext Article VIEW FULL TEXT DOWNLOAD PDF FiguresRelatedReferencesDetailsCited by Clemente A, Pearce M, Skov M and Nadal M (2021) Evaluative judgment across domains: Liking balance, contour, symmetry and complexity in melodies and visual designs, Brain and Cognition, 10.1016/j.bandc.2021.105729, 151, (105729), Online publication date: 1-Jul-2021. Chuan-Peng H, Huang Y, Eickhoff S, Peng K and Sui J (2020) Seeking the "Beauty Center" in the Brain: A Meta-Analysis of fMRI Studies of Beautiful Human Faces and Visual Art, Cognitive, Affective, & Behavioral Neuroscience, 10.3758/s13415-020-00827-z, 20:6, (1200-1215), Online publication date: 1-Dec-2020. Skov M and Nadal M (2020) A Farewell to Art: Aesthetics as a Topic in Psychology and Neuroscience, Perspectives on Psychological Science, 10.1177/1745691619897963, 15:3, (630-642), Online publication date: 1-May-2020. Kalpokas I (2019) Making the Theory Political A Political Theory of Post-Truth, 10.1007/978-3-319-97713-3_4, (87-121), . Kalpokas I (2019) Affective Encounters of the Algorithmic Kind: Post-Truth and Posthuman Pleasure, Social Media + Society, 10.1177/2056305119845678, 5:2, (205630511984567), Online publication date: 1-Apr-2019. Skov M (2019) Aesthetic Appreciation: The View From Neuroimaging, Empirical Studies of the Arts, 10.1177/0276237419839257, 37:2, Online publication date: H, I and (2020) A for We Aesthetic in Human Neuroscience, A and in A New for Arts, This March Article in 2018 The Author(s)Published by the Royal Society. All rights Citations and are available with

Proceedings of the Royal Society B Biological Sciences · editorial or comment · 24 citationsread the source →

Refugee healthcare resilience and burdens: a 10-year mixed-methods analysis of system shocks in Canada.

Background: System shocks, including policy changes, refugee surges, and pandemics, strain healthcare systems. These shocks compound refugee health vulnerabilities, limiting care but may also trigger adaptive responses that build resilience. Understanding local responses is essential for resilient care models. Methods: This sequential explanatory mixed-methods retrospective study (2011-2020) examined how a refugee health centre in Alberta, Canada, responded to four shocks: Interim Federal Health Program (IFHP) Cuts (2012), Syrian Surge (2015), Yazidi Resettlement (2017), and COVID-19 (2020). We hypothesized that each shock would drive temporary utilization changes, reflected in level (immediate) and slope (monthly rate of change) shifts, with corresponding impacts on patients and providers. Interrupted time series analysis estimated level and slope differences in monthly appointments (total, family physician, specialist, multidisciplinary team). Interviews with health centre leaders were thematically analyzed using an adapted Health System Resilience framework and integrated with quantitative findings to assess resilience and operational burdens. Findings: Between 2011 and 2020, 10,661 refugees from 106 countries attended 107,642 appointments. The mean age was 24.49 years (SD 17.09; range 0-107), and 47.82% (5094) were female. Mean monthly appointments increased from 455 to 2,208, with an adjusted level difference of +1656.06 and slope increase of +95.68 (p < 0.0.01). Family physician and multidisciplinary team appointments rose substantially, while specialist care declined during COVID-19. Mean provider hours increased from 175.8 to 1097.3 (6.2-fold). Qualitative analysis indicated resilience capacities but also burnout, vicarious trauma, and financial strain. Integration revealed the centre developed resilience but experienced operational burden. Interpretation: Over a decade, the centre adapted to successive shocks, transforming into a beacon clinic. It demonstrated resilience through care expansion and innovation, at the cost of operational burden. Funding: O'Brien Institute for Public Health and the MSI Foundation of Alberta.

Lancet regional health. Americas · 1 citationsread the source →

Identifying and visualising multimorbidity and comorbidity patterns in patients in the English National Health Service: a population-based study.

Background: Globally, there is a paucity of multimorbidity and comorbidity data, especially for minority ethnic groups and younger people. We estimated the frequency of common disease combinations and identified non-random disease associations for all ages in a multiethnic population. Methods: In this population-based study, we examined multimorbidity and comorbidity patterns stratified by ethnicity or race, sex, and age for 308 health conditions using electronic health records from individuals included on the Clinical Practice Research Datalink linked with the Hospital Episode Statistics admitted patient care dataset in England. We included individuals who were older than 1 year and who had been registered for at least 1 year in a participating general practice during the study period (between April 1, 2010, and March 31, 2015). We identified the most common combinations of conditions and comorbidities for index conditions. We defined comorbidity as the accumulation of additional conditions to an index condition over an individual's lifetime. We used network analysis to identify conditions that co-occurred more often than expected by chance. We developed online interactive tools to explore multimorbidity and comorbidity patterns overall and by subgroup based on ethnicity, sex, and age. Findings: We collected data for 3 872 451 eligible patients, of whom 1 955 700 (50·5%) were women and girls, 1 916 751 (49·5%) were men and boys, 2 666 234 (68·9%) were White, 155 435 (4·0%) were south Asian, and 98 815 (2·6%) were Black. We found that a higher proportion of boys aged 1-9 years (132 506 [47·8%] of 277 158) had two or more diagnosed conditions than did girls in the same age group (106 982 [40·3%] of 265 179), but more women and girls were diagnosed with multimorbidity than were boys aged 10 years and older and men (1 361 232 [80·5%] of 1 690 521 vs 1 161 308 [70·8%] of 1 639 593). White individuals (2 097 536 [78·7%] of 2 666 234) were more likely to be diagnosed with two or more conditions than were Black (59 339 [60·1%] of 98 815) or south Asian individuals (93 617 [60·2%] of 155 435). Depression commonly co-occurred with anxiety, migraine, obesity, atopic conditions, deafness, soft-tissue disorders, and gastrointestinal disorders across all subgroups. Heart failure often co-occurred with hypertension, atrial fibrillation, osteoarthritis, stable angina, myocardial infarction, chronic kidney disease, type 2 diabetes, and chronic obstructive pulmonary disease. Spinal fractures were most strongly non-randomly associated with malignancy in Black individuals, but with osteoporosis in White individuals. Hypertension was most strongly associated with kidney disorders in those aged 20-29 years, but with dyslipidaemia, obesity, and type 2 diabetes in individuals aged 40 years and older. Breast cancer was associated with different comorbidities in individuals from different ethnic groups. Asthma was associated with different comorbidities between males and females. Bipolar disorder was associated with different comorbidities in younger age groups compared with older age groups. Interpretation: Our findings and interactive online tools are a resource for: patients and their clinicians, to prevent and detect comorbid conditions; research funders and policy makers, to redesign service provision, training priorities, and guideline development; and biomedical researchers and manufacturers of medicines, to provide leads for research into common or sequential pathways of disease and inform the design of clinical trials. Funding: UK Research and Innovation, Medical Research Council, National Institute for Health and Care Research, Department of Health and Social Care, Wellcome Trust, British Heart Foundation, and The Alan Turing Institute.

The Lancet. Digital health · 118 citationsread the source →

Racial Discrimination is Associated with Acute Posttraumatic Stress Symptoms and Predicts Future Posttraumatic Stress Disorder Symptom Severity in Trauma-Exposed Black Adults in the United States.

In the United States, Black residents exposed to a traumatic event are at an increased risk of developing posttraumatic stress disorder (PTSD) and experiencing more severe symptoms compared to their non-Hispanic White counterparts. Although previous work has suggested a link between racial discrimination and PTSD symptoms, no studies have assessed this association in a sample of traumatic injury survivors. The current study investigated whether (a) past racial discrimination was associated with acute posttraumatic stress symptoms (PTSS) and (b) discrimination prospectively contributed to the prediction of future PTSD symptoms. African American and/or Black patients (N = 113) were recruited from an emergency department in southeastern Wisconsin. Patients in the acute postinjury phase (i.e., 2 weeks posttrauma) completed self-report measures, with PTSD symptoms assessed using the Clinician-Administered PTSD Scale at 6-month follow-up. Bivariate associations indicated past racial discrimination was significantly related to acute PTSS. A multiple regression analysis revealed that pretrauma exposure to racial discrimination significantly predicted PTSD symptoms at follow-up, even after controlling for age, gender, previous psychiatric diagnosis, social support, and lifetime trauma history. Our results suggest that experiences of racial discrimination add significant additional risk for PTSD symptom development following traumatic injury, R2 = .16, F(6, 106) = 3.25, p = .006. Broadly, these findings add to the body of empirical evidence and personal testimonies of Black individuals in White-centric societies asserting that racial discrimination affects mental health and overall well-being and further highlight the recent call for racism to be classified as a public health crisis.

Journal of traumatic stress · 88 citationsread the source →

Relations of academic procrastination, rationalizations, and performance in a web course with deadlines.

This study compared students' academic procrastination tendency with the (1) frequency and nature of rationalizations used to justify procrastination, (2) self-regulation, and (3) performance in a web-based study strategies course with frequent performance deadlines. 106 college students completed the 16-item Tuckman Procrastination Scale, a measure of tendency to procrastinate, the Frequency of Use Self-survey of Rationalizations for Procrastination, and a 9-item self-regulation scale. Students' subsequent course performance was measured by total points earned. A linear regression with Academic Procrastination as the criterion variable and Rationalization score and Course Points as the predictor variables suggested academic procrastinators support procrastinating by rationalizing, not self-regulating, and thus put themselves at a disadvantage, with respect to evaluation in highly structured courses with frequent enforced deadlines.

Psychological reports · 10 citationsread the source →

Children's fearfulness as a moderator of parenting in early socialization: Two longitudinal studies.

Findings from 2 longitudinal studies replicate and considerably extend past work on child temperament as a moderating link between parenting and successful socialization outcomes. In Study 1 (N = 106 mothers and children), child fearfulness, mother-child positive relationship, and maternal power assertion were assessed at 22 and 33 months; the outcome--children's moral self--was assessed at 56 months. In Study 2 (N = 102 mothers, fathers, and children), child fearfulness and parent-child positive relationship were assessed at 7 and 15 months; parents' power assertion was assessed at 15 months. The outcomes were children's receptive, willing stance toward the parent at 25 months, and rule-compatible conduct without supervision at 38 months. Child fearfulness significantly moderated the impact of parenting: In both studies, for relatively fearless children, mother-child positive relationship predicted future successful socialization outcomes in mother-child dyads. There was no analogous moderation effect in father-child dyads in Study 2. For relatively fearful children, fathers' power assertion in Study 2 predicted poor socialization outcomes. All Temperament x Parenting interactions appeared limited to measures obtained in the 2nd year.

Developmental psychology · 112 citationsread the source →

Cancer mortality in India: a nationally representative survey.

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

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

An evaluation of the effect of infertility on marital, sexual satisfaction indices and health-related quality of life in women.

Background: The effect of infertility on marital and sexual functioning, health-related quality of life (QoL) and the acceptability of the treatment modalities is a poorly researched area in India. Aims and objectives: To measure and compare the impact of infertility on marital adjustment, sexual functioning, QoL and the acceptability of various treatment modalities in infertility. Design and setting: Hospital-based cross-sectional controlled study. Materials and methods: Data regarding infertility, socio-demographic characteristics and treatment acceptability was obtained via a semi-structured questionnaire. validated, standardized scales were used to measure marital adjustment (abbreviated dyadic adjustment scale), sexual functioning (abbreviated sexual functioning questionnaire) in cases and controls, and quality of life (FertiQol) in cases. Data from 106 women attending tertiary infertility centers who met the definition of primary infertility and 212 controls attending the medical outpatient department in the same centers was obtained. Results: Body mass index and socioeconomic status were significant (P < 0.006 and < 0.0001 respectively) for infertility. Fertility-enhancing regimens and adoption had the highest acceptability with a wide dispersion of range for adoption and least acceptance for sperm, egg, embryo donation and surrogate motherhood. Logistic regression analysis revealed a significant effect size of infertility on marital adjustment (Nagelkerke R(2) 0.725, Cohen's D 0.86) and sexual functioning (Nagelkerke R(2) 0.73, Cohen's D 0.815). QoL showed a decrease in mean scores on the FertiQol scale similar to normative data. Conclusions: Effective counseling, reassurance and measures to reduce the impact of the condition on marital and sexual life, overall QoL are needed to impart a holistic treatment in infertility.

Journal of human reproductive sciences · 62 citationsread the source →