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Two Randomized Controlled Trials to Help Teachers Develop Physical Education Students' Course-Specific Grit-Perseverance and Mental Toughness.

Adopting both a self-determination theory perspective and a proactive, asset-oriented approach to coping with stressors, we propose a hypothesized model to explain physical education students' year-long development of course-specific grit-perseverance (Study 1) and mental toughness (Study 2). In both studies, we used a randomized controlled trial research design with longitudinally assessed dependent measures (four waves) to test a hypothesized model in which teacher participation in an autonomy-supportive teaching workshop (experimental condition) would increase students' T2 perceived autonomy-supportive teaching and T2 perceived autonomy-supportive classmates, both of which would increase T3 need satisfaction, which would then explain longitudinal gains in students' T4 grit-perseverance (Study 1) and mental toughness (Study 2). In both Study 1 (57 teachers, 3,147 students) and Study 2 (38 teachers, 2,057 students), a multilevel structural equation modeling analysis showed that the hypothesized model fit the data very well. We conclude that the developmental roots of grit-perseverance and mental toughness can emerge proactively out of the asset-oriented experiences of interpersonal support and psychological need satisfaction that are central to self-determination theory.

Journal of sport & exercise psychology · randomised controlled trial · 1 citationsread the source →

Prevalence of symptoms of anxiety and depression in patients with inflammatory bowel disease: a systematic review and meta-analysis.

Background: Inflammatory bowel disease (IBD) is a lifelong condition with no cure. Patients with IBD might experience symptoms of common mental disorders such as anxiety and depression because of bidirectional communication via the gut-brain axis and chronicity of symptoms, and because of impaired quality of life and reduced social functioning. However, uncertainties remain about the magnitude of this problem. We aimed to assess prevalence of symptoms of anxiety or depression in adult patients with IBD. Methods: In this systematic review and meta-analysis, we searched MEDLINE, Embase, Embase Classic, and PsycINFO for papers published from inception to Sept 30, 2020, reporting observational studies that recruited at least 100 adult patients with IBD and that reported prevalence of symptoms of anxiety or depression according to validated screening instruments. We excluded studies that only used a structured interview to assess for these symptoms and studies that did not provide extractable data. We extracted data from published study reports and calculated pooled prevalences of symptoms of anxiety and depression, odds ratios (OR), and 95% CIs. Findings: Of 5544 studies identified, 77 fulfilled the eligibility criteria, including 30 118 patients in total. Overall, pooled prevalence of anxiety symptoms was 32·1% (95% CI 28·3-36·0) in 58 studies (I2=96·9%) and pooled prevalence of depression symptoms was 25·2% (22·0-28·5) in 75 studies (I2=97·6%). In studies that reported prevalence of anxiety or depression in patients with Crohn's disease and ulcerative colitis within the same study population, patients with Crohn's disease had higher odds of anxiety symptoms (OR 1·2, 95% CI 1·1-1·4) and depression symptoms (1·2, 1·1-1·4) than patients with ulcerative colitis. Overall, women with IBD were more likely to have symptoms of anxiety than were men with IBD (pooled prevalence 33·8% [95% CI 26·5-41·5] for women vs 22·8% [18·7-27·2] for men; OR 1·7 [95% CI 1·2-2·3]). They were also more likely to have symptoms of depression than men were (pooled prevalence 21·2% [95% CI 15·4-27·6] for women vs 16·2% [12·6-20·3] for men; OR 1·3 [95% CI 1·0-1·8]). The prevalence of symptoms of anxiety (57·6% [95% CI 38·6-75·4]) or depression (38·9% [26·2-52·3]) was higher in patients with active IBD than in patients with inactive disease (38·1% [30·9-45·7] for anxiety symptoms and 24·2% [14·7-35·3] for depression symptoms; ORs 2·5 [95% CI 1·5-4·1] for anxiety and 3·1 [1·9-4·9] for depression). Interpretation: There is a high prevalence of symptoms of anxiety and depression in patients with IBD, with up to a third of patients affected by anxiety symptoms and a quarter affected by depression symptoms. Prevalence was also increased in patients with active disease: half of these patients met criteria for anxiety symptoms and a third met criteria for depression symptoms. Encouraging gastroenterologists to screen for and treat these disorders might improve outcomes for patients with IBD. Funding: None.

The lancet. Gastroenterology & hepatology · meta-analysis · 514 citationsread the source →

Abusive head trauma and accidental head injury: a 20-year comparative study of referrals to a hospital child protection team.

Aim: To describe children referred for suspected abusive head trauma (AHT) to a hospital child protection team in Auckland, New Zealand. Methods: Comparative review of demographics, histories, injuries, investigations and diagnostic outcomes for referrals under 15 years old from 1991 to 2010. Results: Records were available for 345 children. Referrals increased markedly (88 in the first decade, 257 in the second), but the diagnostic ratio was stable: AHT 60%, accidental or natural 29% and uncertain cause 11%. The probability of AHT was similar regardless of socio-economic status or ethnicity. In children under 2 years old with accidental head injuries (75/255, 29%) or AHT (180/255, 71%), characteristics of particular interest for AHT included no history of trauma (88/98, 90%), no evidence of impact to the head (84/93, 90%), complex skull fractures with intracranial injury (22/28, 79%), subdural haemorrhage (160/179, 89%) and hypoxic ischaemic injury (38/39, 97%). In children over 2 years old, these characteristics did not differ significantly between children with accidental head injuries (21/47, 45%) and AHT (26/47, 55%). The mortality of AHT was higher in children over 2 years old (10/26, 38%) than under 2 years (19/180, 11%). Conclusions: The striking increase in referrals for AHT probably represents increasing incidence. The decision to refer a hospitalised child with a head injury for assessment for possible AHT should not be influenced by socio-economic status or ethnicity. Children over 2 years old hospitalised for AHT are usually injured by mechanisms involving impact and should be considered at high risk of death.

Archives of disease in childhood · cohort or longitudinal · 63 citationsread the source →

Group Cognitive Behavioral Therapy and Attention Bias Modification for Childhood Anxiety Disorders: A Factorial Randomized Trial of Efficacy.

Background: The objective of this study is to assess group differences in symptom reduction between individuals receiving group cognitive behavioral therapy (G-CBT) and attention bias modification (ABM) compared to their respective control interventions, control therapy (CT), and attention control training (ACT), in a 2 × 2 factorial design. Methods: A total of 310 treatment-naive children (7-11 years of age) were assessed for eligibility and 79 children with generalized, separation or social anxiety disorder were randomized and received G-CBT (n = 42) or CT (n = 37). Within each psychotherapy group, participants were again randomized to ABM (n = 38) or ACT (n = 41) in a 2 × 2 factorial design resulting in four groups: G-CBT + ABM (n = 21), G-CBT + ACT (n = 21), CT + ABM (n = 17), and CT + ACT (n = 20). Primary outcomes were responder designation as defined by Clinical Global Impression-Improvement (CGI-I) scale (≤2) and change on the Pediatric Anxiety Rating Scale (PARS). Results: There were significant improvements of symptoms in all groups. No differences in response rates or mean differences in PARS scores were found among groups: G-CBT + ABM group (23.8% response; 3.9 points, 95% confidence interval [CI] -0.3 to 8.1), G-CBT + ACT (42.9% response; 5.6 points, 95% CI 2.2-9.0), CT + ABM (47.1% response; 4.8 points 95% CI 1.08-8.57), and CT + ACT (30% response; 0.8 points, 95% CI -3.0 to 4.7). No evidence or synergic or antagonistic effects were found, but the combination of G-CBT and ABM was found to increase dropout rate. Conclusions: We found no effect of G-CBT or ABM beyond the effects of comparison groups. Results reveal no benefit from combining G-CBT and ABM for anxiety disorders in children and suggest potential deleterious effects of the combination on treatment acceptability.

Journal of child and adolescent psychopharmacology · randomised controlled trial · 15 citationsread the source →

Prevalence of depressive disorders and treatment in China: a cross-sectional epidemiological study.

Background: In China, depressive disorders have been estimated to be the second leading cause of years lived with disability. However, nationally representative epidemiological data for depressive disorders, in particular use of mental health services by adults with these disorders, are unavailable in China. The present study, part of the China Mental Health Survey, 2012-15, aims to describe the socioeconomic characteristics and the use of mental health services in people with depressive disorders in China. Methods: The China Mental Health Survey was a cross-sectional epidemiological survey of mental disorders in a multistage clustered-area probability sample of adults of Chinese nationality (≥18 years) from 157 nationwide representative population-based disease surveillance points in 31 provinces across China. Trained investigators interviewed the participants with the Composite International Diagnostic Interview 3.0 to ascertain the presence of lifetime and 12-month depressive disorders according to DSM-IV criteria, including major depressive disorder, dysthymic disorder, and depressive disorder not otherwise specified. Participants with 12-month depressive disorders were asked whether they received any treatment for their emotional problems during the past 12 months and, if so, the specific types of treatment providers. The Sheehan Disability Scale (SDS) was used to assess impairments associated with 12-month depressive symptoms. Data-quality control procedures included logic check by computers, sequential recording check, and phone-call check by the quality controllers, and reinterview check by the psychiatrists. Data were weighted according to the age-sex-residence distribution data from China's 2010 census population survey to adjust for differential probabilities of selection and differential response, as well as to post-stratify the sample to match the population distribution. Findings: 28 140 respondents (12 537 [44·6%] men and 15 603 [55·4%] women) completed the survey between July 22, 2013, and March 5, 2015. Ethnicity data (Han or non-Han) were collected for only a subsample. Prevalence of any depressive disorders was higher in women than men (lifetime prevalence odds ratio [OR] 1·44 [95% CI 1·20-1·72] and 12-month prevalence OR 1·41 [1·12-1·78]), in unemployed people than employed people (lifetime OR 2·38 [95% CI 1·68-3·38] and 12-month OR 2·80 [95% CI 1·88-4·18]), and in people who were separated, widowed, or divorced compared with those who were married or cohabiting (lifetime OR 1·87 [95% CI 1·39-2·51] and 12-month OR 1·85 [95% CI 1·40-2·46]). Overall, 574 (weighted % 75·9%) of 744 people with 12-month depressive disorders had role impairment of any SDS domain: 439 (83·6%) of 534 respondents with major depressive disorder, 207 (79·8%) of 254 respondents with dysthymic disorder, and 122 (59·9%) of 189 respondents with depressive disorder not otherwise specified. Only an estimated 84 (weighted % 9·5%) of 1007 participants with 12-month depressive disorders were treated in any treatment sector: 38 (3·6%) in speciality mental health, 20 (1·5%) in general medical, two (0·3%) in human services, and 21 (2·7%) in complementary and alternative medicine. Only 12 (0·5%) of 1007 participants with depressive disorders were treated adequately. Interpretation: Depressive disorders in China were more prevalent in women than men, unemployed people than employed, and those who were separated, widowed, or divorced than people who were married or cohabiting. Most people with depressive disorders reported social impairment. Treatment rates were very low, and few people received adequate treatment. National programmes are needed to remove barriers to availability, accessibility, and acceptability of care for depression in China. Funding: National Health Commission and Ministry of Science and Technology of People's Republic of China. Translation: For the Chinese translation of the abstract see Supplementary Materials section.

The lancet. Psychiatry · 591 citationsread the source →

A systematic review of influences on implementation of peer support work for adults with mental health problems.

Purpose: The evidence base for peer support work in mental health is established, yet implementation remains a challenge. The aim of this systematic review was to identify influences which facilitate or are barriers to implementation of mental health peer support work. Methods: Data sources comprised online databases (n = 11), journal table of contents (n = 2), conference proceedings (n = 18), peer support websites (n = 2), expert consultation (n = 38) and forward and backward citation tracking. Publications were included if they reported on implementation facilitators or barriers for formal face-to-face peer support work with adults with a mental health problem, and were available in English, French, German, Hebrew, Luganda, Spanish or Swahili. Data were analysed using narrative synthesis. A six-site international survey [Germany (2 sites), India, Israel, Tanzania, Uganda] using a measure based on the strongest influences was conducted. The review protocol was pre-registered (Prospero: CRD42018094838). Results: The search strategy identified 5813 publications, of which 53 were included. Fourteen implementation influences were identified, notably organisational culture (reported by 53% of papers), training (42%) and role definition (40%). Ratings on a measure using these influences demonstrated preliminary evidence for the convergent and discriminant validity of the identified influences. Conclusion: The identified influences provide a guide to implementation of peer support. For services developing a peer support service, organisational culture including role support (training, role clarity, resourcing and access to a peer network) and staff attitudes need to be considered. The identified influences provide a theory base to prepare research sites for implementing peer support worker interventions.

Social psychiatry and psychiatric epidemiology · systematic review · 139 citationsread the source →

Sumatriptan-naproxen for acute treatment of migraine: a randomized trial.

Context: Multiple pathogenic mechanisms may be involved in generating the migraine symptom complex, and multimechanism-targeted therapy may confer advantages over monotherapy. Objective: To evaluate the efficacy and safety of a fixed-dose tablet containing sumatriptan succinate and naproxen sodium relative to efficacy and safety of each monotherapy and placebo for the acute treatment of migraine. Design, setting, and participants: Two replicate, randomized, double-blind, single-attack, parallel-group studies conducted among 1461 (study 1) and 1495 (study 2) patients at 118 US clinical centers who were diagnosed as having migraine and received study treatment for a moderate or severe migraine attack. Interventions: Patients were randomized in a 1:1:1:1 ratio to receive a single tablet containing sumatriptan, 85 mg, and naproxen sodium, 500 mg; sumatriptan, 85 mg (monotherapy); naproxen sodium, 500 mg (monotherapy); or placebo, to be used after onset of a migraine with moderate to severe pain. Main outcome measures: Primary outcome measures included the percentages of patients with headache relief 2 hours after dosing, absence of photophobia, absence of phonophobia, and absence of nausea for the comparison between sumatriptan-naproxen sodium and placebo, and the percentages of patients with sustained pain-free response for the comparison between sumatriptan-naproxen sodium and each monotherapy. Results: Sumatriptan-naproxen sodium was more effective than placebo for headache relief at 2 hours after dosing (study 1, 65% vs 28%; P<.001 and study 2, 57% vs 29%; P<.001), absence of photophobia at 2 hours (58% vs 26%; P<.001 and 50% vs 32%; P<.001), and absence of phonophobia at 2 hours (61% vs 38%; P<.001 and 56% vs 34%; P<.001). The absence of nausea 2 hours after dosing was higher with sumatriptan-naproxen sodium than placebo in study 1 (71% vs 65%; P = .007), but in study 2 rates of absence of nausea did not differ between sumatriptan-naproxen sodium and placebo (65% vs 64%; P = .71). For 2- to 24-hour sustained pain-free response, sumatriptan-naproxen sodium was superior at P<.01 (25% and 23% in studies 1 and 2, respectively) to sumatriptan monotherapy (16% and 14% in studies 1 and 2), naproxen sodium monotherapy (10% and 10% in studies 1 and 2), and placebo (8% and 7% in studies 1 and 2). The incidence of adverse events was similar between sumatriptan-naproxen sodium and sumatriptan monotherapy. Conclusion: Sumatriptan, 85 mg, plus naproxen sodium, 500 mg, as a single tablet for acute treatment of migraine resulted in more favorable clinical benefits compared with either monotherapy, with an acceptable and well-tolerated adverse effect profile. Trial registration: clinicaltrials.gov Identifiers: NCT00434083 (study 1); NCT00433732 (study 2).

JAMA · randomised controlled trial · 181 citationsread the source →

Effect of dignity therapy on distress and end-of-life experience in terminally ill patients: a randomised controlled trial.

Background: Dignity therapy is a unique, individualised, short-term psychotherapy that was developed for patients (and their families) living with life-threatening or life-limiting illness. We investigated whether dignity therapy could mitigate distress or bolster the experience in patients nearing the end of their lives. Methods: Patients (aged ≥18 years) with a terminal prognosis (life expectancy ≤6 months) who were receiving palliative care in a hospital or community setting (hospice or home) in Canada, USA, and Australia were randomly assigned to dignity therapy, client-centred care, or standard palliative care in a 1:1:1 ratio. Randomisation was by use of a computer-generated table of random numbers in blocks of 30. Allocation concealment was by use of opaque sealed envelopes. The primary outcomes--reductions in various dimensions of distress before and after completion of the study--were measured with the Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Scale, Patient Dignity Inventory, Hospital Anxiety and Depression Scale, items from the Structured Interview for Symptoms and Concerns, Quality of Life Scale, and modified Edmonton Symptom Assessment Scale. Secondary outcomes of self-reported end-of-life experiences were assessed in a survey that was undertaken after the completion of the study. Outcomes were assessed by research staff with whom the participant had no previous contact to avoid any possible response bias or contamination. Analyses were done on all patients with available data at baseline and at the end of the study intervention. This study is registered with ClinicalTrials.gov, number NCT00133965. Findings: 165 of 441 patients were assigned to dignity therapy, 140 standard palliative care, and 136 client-centred care. 108, 111, and 107 patients, respectively, were analysed. No significant differences were noted in the distress levels before and after completion of the study in the three groups. For the secondary outcomes, patients reported that dignity therapy was significantly more likely than the other two interventions to have been helpful (χ(2)=35·50, df=2; p<0·0001), improve quality of life (χ(2)=14·52; p=0·001), increase sense of dignity (χ(2)=12·66; p=0·002), change how their family saw and appreciated them (χ(2)=33·81; p<0·0001), and be helpful to their family (χ(2)=33·86; p<0·0001). Dignity therapy was significantly better than client-centred care in improving spiritual wellbeing (χ(2)=10·35; p=0·006), and was significantly better than standard palliative care in terms of lessening sadness or depression (χ(2)=9·38; p=0·009); significantly more patients who had received dignity therapy reported that the study group had been satisfactory, compared with those who received standard palliative care (χ(2)=29·58; p<0·0001). Interpretation: Although the ability of dignity therapy to mitigate outright distress, such as depression, desire for death or suicidality, has yet to be proven, its benefits in terms of self-reported end-of-life experiences support its clinical application for patients nearing death. Funding: National Cancer Institute, National Institutes of Health.

The Lancet. Oncology · randomised controlled trial · 449 citationsread the source →

Whole-gland ablation of localized prostate cancer with high-intensity focused ultrasound: oncologic outcomes and morbidity in 1002 patients.

Background: High-intensity focused ultrasound (HIFU) is a nonsurgical therapy for selected patients with localized prostate cancer (PCa). Objective: The long-term oncologic and morbidity outcomes of primary HIFU therapy for localized PCa were evaluated in a prospective, single-arm, single-institution cohort study. Design, setting, and participants: Participants were patients treated with HIFU for localized PCa from 1997 to 2009. Excluded were patients with local recurrence following radiotherapy. A second HIFU session was systematically performed in patients with biopsy-proven local recurrence. Intervention: Whole-gland prostate ablation with transrectal HIFU. Outcome measurements and statistical analysis: Incontinence was assessed using the Ingelman-Sundberg score, and potency was assessed using the five-item version of the International Index of Erectile Function (IIEF-5) scores. Primary outcomes were survival rates (biochemical-free, cancer-specific, metastasis-free, and overall survival). Secondary outcomes were morbidity rates. Median follow-up was 6.4 yr (range: 0.2-13.9). The Kaplan-Meier method was used to determine survival estimates, and multivariate analysis was used to determine predictive factors of biochemical progression. Results and limitations: A total of 1002 patients were included. The median nadir prostate-specific antigen (PSA) was 0.14 ng/ml, with 63% of patients reaching a nadir PSA ≤0.3 ng/ml. Sixty percent of patients received one HIFU session, 38% received two sessions, and 2% received three sessions. The 8-yr biochemical-free survival rates (Phoenix definition) were 76%, 63%, and 57% for low-, intermediate-, and high-risk patients, respectively (p < 0.001). At 10 yr, the PCa-specific survival rate and metastasis-free survival rate (MFSR) were 97% and 94%, respectively. Salvage therapies included external-beam radiation therapy (EBRT) (13.8%), EBRT plus androgen-deprivation therapy (ADT) (9.7%), and ADT alone (12.1%). Severe incontinence and bladder outlet obstruction decreased with refinement in the technology, from 6.4% and 34.9% to 3.1% and 5.9%, respectively. Limitations included the fact that the study was a single-arm study without a comparison group, technological improvements, changes in surgical protocol during the study, and the use of ADT to downsize the prostate in 39% of patients. Conclusions: HIFU is a potentially effective treatment of localized PCa, with a low PCa-specific mortality rate and a high MFSR at 10 yr as well as acceptable morbidity.

European urology · clinical trial · 135 citationsread the source →

Effect of testicular sperm extraction outcome on sexual function in patients with male factor infertility.

Objectives: To document the effects of the outcome of testicular sperm extraction (TESE) procedures on erectile function in patients with male factor infertility. Methods: A total of 66 nonobstructive azoospermic patients were divided into 2 groups: group I, with sperm-positive results and group II, with sperm-negative results. The patients were evaluated with the International Index of Erectile Function-5 (IIEF-5) and Hospital Anxiety-Depression Scale. Hormones were analyzed before and 6 months after the procedure. Each group was compared with the use of the paired t test, where P <.05 was accepted as statistically significant. Results: The mean patient age was 34.8 years (range 24-53). Of 66 cases, 26 (40%) experienced positive results for the TESE. The median IIEF-5 score before TESE for group I and group II was 22 (minimum: 11, maximum: 25) and 23 (minimum: 10, maximum: 25), respectively. The median IIEF-5 score after TESE for group I and group II was 23.5 (minimum: 10, maximum: 25) and 18 (minimum: 15, maximum: 25), respectively. In patients who reported new onset erectile dysfunction (ED) 6 months after surgery, the mean follicle-stimulating hormone and luteinizing hormone levels increased from 21 +/- 2 to 38 +/- 3 IU/L (P <.001), and from 11 +/- 2 to 14 +/- 2 IU/L (P >.05), respectively. The mean total testosterone level decreased from 7.83 +/- 2 to 2.8 +/- 2 ng/mL (P <.001). The Hospital Anxiety and Depression Scale revealed that patients who reported new onset ED also reported both depression and anxiety. Conclusions: Unsuccessful TESE procedures might have a negative effect on erectile function because of hormonal and psychological reasons. The andrologist should treat the ED of the patients and refer them to the psychiatrist for anxiety and depression assessment.

Urology · 22 citationsread the source →

Digital Health Interventions for Depression and Anxiety Among People With Chronic Conditions: Scoping Review.

Background: Chronic conditions are characterized by their long duration (≥1 year), need for ongoing medical attention, and limitations in activities of daily living. These can often co-occur with depression and anxiety as common and detrimental comorbidities among the growing population living with chronic conditions. Digital health interventions (DHIs) hold promise in overcoming barriers to accessing mental health support for these individuals; however, the design and implementation of DHIs for depression and anxiety in people with chronic conditions are yet to be explored. Objective: This study aimed to explore what is known in the literature regarding DHIs for the prevention, detection, or treatment of depression and anxiety among people with chronic conditions. Methods: A scoping review of the literature was conducted using the Arksey and O'Malley framework. Searches of the literature published in 5 databases between 1990 and 2019 were conducted in April 2019 and updated in March 2021. To be included, studies must have described a DHI tested with, or designed for, the prevention, detection, or treatment of depression or anxiety in people with common chronic conditions (arthritis, asthma, diabetes mellitus, heart disease, chronic obstructive pulmonary disease, cancer, stroke, and Alzheimer disease or dementia). Studies were independently screened by 2 reviewers against the inclusion and exclusion criteria. Both quantitative and qualitative data were extracted, charted, and synthesized to provide a descriptive summary of the trends and considerations for future research. Results: Database searches yielded 11,422 articles across the initial and updated searches, 53 (0.46%) of which were included in this review. DHIs predominantly sought to provide treatment (44/53, 83%), followed by detection (5/53, 9%) and prevention (4/53, 8%). Most DHIs were focused on depression (36/53, 68%), guided (32/53, 60%), tailored to chronic physical conditions (19/53, 36%), and delivered through web-based platforms (20/53, 38%). Only 2 studies described the implementation of a DHI. Conclusions: As a growing research area, DHIs offer the potential to address the gap in care for depression and anxiety among people with chronic conditions; however, their implementation in standard care is scarce. Although stepped care has been identified as a promising model to implement efficacious DHIs, few studies have investigated the use of DHIs for depression and anxiety among chronic conditions using such models. In developing stepped care, we outlined DHI tailoring, guidance, and intensity as key considerations that require further research.

Journal of medical Internet research · review · 23 citationsread the source →

Burden of 375 diseases and injuries, risk-attributable burden of 88 risk factors, and healthy life expectancy in 204 countries and territories, including 660 subnational locations, 1990-2023: a systematic analysis for the Global Burden of Disease Study 2023.

Background: For more than three decades, the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) has provided a framework to quantify health loss due to diseases, injuries, and associated risk factors. This paper presents GBD 2023 findings on disease and injury burden and risk-attributable health loss, offering a global audit of the state of world health to inform public health priorities. This work captures the evolving landscape of health metrics across age groups, sexes, and locations, while reflecting on the remaining post-COVID-19 challenges to achieving our collective global health ambitions. Methods: The GBD 2023 combined analysis estimated years lived with disability (YLDs), years of life lost (YLLs), and disability-adjusted life-years (DALYs) for 375 diseases and injuries, and risk-attributable burden associated with 88 modifiable risk factors. Of the more than 310 000 total data sources used for all GBD 2023 (about 30% of which were new to this estimation round), more than 120 000 sources were used for estimation of disease and injury burden and 59 000 for risk factor estimation, and included vital registration systems, surveys, disease registries, and published scientific literature. Data were analysed using previously established modelling approaches, such as disease modelling meta-regression version 2.1 (DisMod-MR 2.1) and comparative risk assessment methods. Diseases and injuries were categorised into four levels on the basis of the established GBD cause hierarchy, as were risk factors using the GBD risk hierarchy. Estimates stratified by age, sex, location, and year from 1990 to 2023 were focused on disease-specific time trends over the 2010-23 period and presented as counts (to three significant figures) and age-standardised rates per 100 000 person-years (to one decimal place). For each measure, 95% uncertainty intervals [UIs] were calculated with the 2·5th and 97·5th percentile ordered values from a 250-draw distribution. Findings: Total numbers of global DALYs grew 6·1% (95% UI 4·0-8·1), from 2·64 billion (2·46-2·86) in 2010 to 2·80 billion (2·57-3·08) in 2023, but age-standardised DALY rates, which account for population growth and ageing, decreased by 12·6% (11·0-14·1), revealing large long-term health improvements. Non-communicable diseases (NCDs) contributed 1·45 billion (1·31-1·61) global DALYs in 2010, increasing to 1·80 billion (1·63-2·03) in 2023, alongside a concurrent 4·1% (1·9-6·3) reduction in age-standardised rates. Based on DALY counts, the leading level 3 NCDs in 2023 were ischaemic heart disease (193 million [176-209] DALYs), stroke (157 million [141-172]), and diabetes (90·2 million [75·2-107]), with the largest increases in age-standardised rates since 2010 occurring for anxiety disorders (62·8% [34·0-107·5]), depressive disorders (26·3% [11·6-42·9]), and diabetes (14·9% [7·5-25·6]). Remarkable health gains were made for communicable, maternal, neonatal, and nutritional (CMNN) diseases, with DALYs falling from 874 million (837-917) in 2010 to 681 million (642-736) in 2023, and a 25·8% (22·6-28·7) reduction in age-standardised DALY rates. During the COVID-19 pandemic, DALYs due to CMNN diseases rose but returned to pre-pandemic levels by 2023. From 2010 to 2023, decreases in age-standardised rates for CMNN diseases were led by rate decreases of 49·1% (32·7-61·0) for diarrhoeal diseases, 42·9% (38·0-48·0) for HIV/AIDS, and 42·2% (23·6-56·6) for tuberculosis. Neonatal disorders and lower respiratory infections remained the leading level 3 CMNN causes globally in 2023, although both showed notable rate decreases from 2010, declining by 16·5% (10·6-22·0) and 24·8% (7·4-36·7), respectively. Injury-related age-standardised DALY rates decreased by 15·6% (10·7-19·8) over the same period. Differences in burden due to NCDs, CMNN diseases, and injuries persisted across age, sex, time, and location. Based on our risk analysis, nearly 50% (1·27 billion [1·18-1·38]) of the roughly 2·80 billion total global DALYs in 2023 were attributable to the 88 risk factors analysed in GBD. Globally, the five level 3 risk factors contributing the highest proportion of risk-attributable DALYs were high systolic blood pressure (SBP), particulate matter pollution, high fasting plasma glucose (FPG), smoking, and low birthweight and short gestation-with high SBP accounting for 8·4% (6·9-10·0) of total DALYs. Of the three overarching level 1 GBD risk factor categories-behavioural, metabolic, and environmental and occupational-risk-attributable DALYs rose between 2010 and 2023 only for metabolic risks, increasing by 30·7% (24·8-37·3); however, age-standardised DALY rates attributable to metabolic risks decreased by 6·7% (2·0-11·0) over the same period. For all but three of the 25 leading level 3 risk factors, age-standardised rates dropped between 2010 and 2023-eg, declining by 54·4% (38·7-65·3) for unsafe sanitation, 50·5% (33·3-63·1) for unsafe water source, and 45·2% (25·6-72·0) for no access to handwashing facility, and by 44·9% (37·3-53·5) for child growth failure. The three leading level 3 risk factors for which age-standardised attributable DALY rates rose were high BMI (10·5% [0·1 to 20·9]), drug use (8·4% [2·6 to 15·3]), and high FPG (6·2% [-2·7 to 15·6]; non-significant). Interpretation: Our findings underscore the complex and dynamic nature of global health challenges. Since 2010, there have been large decreases in burden due to CMNN diseases and many environmental and behavioural risk factors, juxtaposed with sizeable increases in DALYs attributable to metabolic risk factors and NCDs in growing and ageing populations. This long-observed consequence of the global epidemiological transition was only temporarily interrupted by the COVID-19 pandemic. The substantially decreasing CMNN disease burden, despite the 2008 global financial crisis and pandemic-related disruptions, is one of the greatest collective public health successes known. However, these achievements are at risk of being reversed due to major cuts to development assistance for health globally, the effects of which will hit low-income countries with high burden the hardest. Without sustained investment in evidence-based interventions and policies, progress could stall or reverse, leading to widespread human costs and geopolitical instability. Moreover, the rising NCD burden necessitates intensified efforts to mitigate exposure to leading risk factors-eg, air pollution, smoking, and metabolic risks, such as high SBP, BMI, and FPG-including policies that promote food security, healthier diets, physical activity, and equitable and expanded access to potential treatments, such as GLP-1 receptor agonists. Decisive, coordinated action is needed to address long-standing yet growing health challenges, including depressive and anxiety disorders. Yet this can be only part of the solution. Our response to the NCD syndemic-the complex interaction of multiple health risks, social determinants, and systemic challenges-will define the future landscape of global health. To ensure human wellbeing, economic stability, and social equity, global action to sustain and advance health gains must prioritise reducing disparities by addressing socioeconomic and demographic determinants, ensuring equitable health-care access, tackling malnutrition, strengthening health systems, and improving vaccination coverage. We live in times of great opportunity. Funding: Gates Foundation and Bloomberg Philanthropies.

Lancet (London, England) · 257 citationsread the source →

Therapist-supported Internet cognitive behavioural therapy for anxiety disorders in adults.

Background: Cognitive behavioural therapy (CBT) is an evidence-based treatment for anxiety disorders. Many people have difficulty accessing treatment, due to a variety of obstacles. Researchers have therefore explored the possibility of using the Internet to deliver CBT; it is important to ensure the decision to promote such treatment is grounded in high quality evidence. Objectives: To assess the effects of therapist-supported Internet CBT (ICBT) on remission of anxiety disorder diagnosis and reduction of anxiety symptoms in adults as compared to waiting list control, unguided CBT, or face-to-face CBT. Effects of treatment on quality of life and patient satisfaction with the intervention were also assessed. Search methods: We searched the Cochrane Depression, Anxiety and Neurosis Review Group Specialised Register (CCDANCTR) to 16 March 2015. The CCDANCTR includes relevant randomised controlled trials from MEDLINE, EMBASE, PsycINFO and CENTRAL. We also searched online clinical trial registries and reference lists of included studies. We contacted authors to locate additional trials. Selection criteria: Each identified study was independently assessed for inclusion by two authors. To be included, studies had to be randomised controlled trials of therapist-supported ICBT compared to a waiting list, attention, information, or online discussion group; unguided CBT (that is, self-help); or face-to-face CBT. We included studies that treated adults with an anxiety disorder (panic disorder, agoraphobia, social phobia, post-traumatic stress disorder, acute stress disorder, generalized anxiety disorder, obsessive compulsive disorder, and specific phobia) defined according to the Diagnostic and Statistical Manual of Mental Disorders III, III-R, IV, IV-TR or the International Classification of Disesases 9 or 10. Data collection and analysis: Two authors independently assessed the risk of bias of included studies and judged overall study quality. We used data from intention-to-treat analyses wherever possible. We assessed treatment effect for the dichotomous outcome of clinically important improvement in anxiety using a risk ratio (RR) with 95% confidence interval (CI). For disorder-specific and general anxiety symptom measures and quality of life we assessed continuous scores using standardized mean differences (SMD). We examined statistical heterogeneity using the I(2) statistic. Main results: We screened 1736 citations and selected 38 studies (3214 participants) for inclusion. The studies examined social phobia (11 trials), panic disorder with or without agoraphobia (8 trials), generalized anxiety disorder (5 trials), post-traumatic stress disorder (2 trials), obsessive compulsive disorder (2 trials), and specific phobia (2 trials). Eight remaining studies included a range of anxiety disorder diagnoses. Studies were conducted in Sweden (18 trials), Australia (14 trials), Switzerland (3 trials), the Netherlands (2 trials), and the USA (1 trial) and investigated a variety of ICBT protocols. Three primary comparisons were identified, therapist-supported ICBT versus waiting list control, therapist-supported versus unguided ICBT, and therapist-supported ICBT versus face-to-face CBT.Low quality evidence from 11 studies (866 participants) contributed to a pooled risk ratio (RR) of 3.75 (95% CI 2.51 to 5.60; I(2) = 50%) for clinically important improvement in anxiety at post-treatment, favouring therapist-supported ICBT over a waiting list, attention, information, or online discussion group only. The SMD for disorder-specific symptoms at post-treatment (28 studies, 2147 participants; SMD -1.06, 95% CI -1.29 to -0.82; I(2) = 83%) and general anxiety symptoms at post-treatment (19 studies, 1496 participants; SMD -0.75, 95% CI -0.98 to -0.52; I(2) = 78%) favoured therapist-supported ICBT; the quality of the evidence for both outcomes was low. One study compared unguided CBT to therapist-supported ICBT for clinically important improvement in anxiety at post-treatment, showing no difference in outcome between treatments (54 participants; very low quality evidence). At post-treatment there were no clear differences between unguided CBT and therapist-supported ICBT for disorder-specific anxiety symptoms (5 studies, 312 participants; SMD -0.22, 95% CI -0.56 to 0.13; I(2) = 58%; very low quality evidence) or general anxiety symptoms (2 studies, 138 participants; SMD 0.28, 95% CI -2.21 to 2.78; I(2) = 0%; very low quality evidence).Compared to face-to-face CBT, therapist-supported ICBT showed no significant differences in clinically important improvement in anxiety at post-treatment (4 studies, 365 participants; RR 1.09, 95% CI 0.89 to 1.34; I(2) = 0%; low quality evidence). There were also no clear differences between face-to-face and therapist supported ICBT for disorder-specific anxiety symptoms at post-treatment (7 studies, 450 participants; SMD 0.06, 95% CI -0.25 to 0.37; I(2) = 60%; low quality evidence) or general anxiety symptoms at post-treatment (5 studies, 317 participants; SMD 0.17, 95% CI -0.35 to 0.69; I(2) = 78%; low quality evidence).Overall, risk of bias in included studies was low or unclear for most domains. However, due to the nature of psychosocial intervention trials, blinding of participants and personnel, and outcome assessment tended to have a high risk of bias. Heterogeneity across a number of the meta-analyses was substantial, some was explained by type of anxiety disorder or may be meta-analytic measurement artefact due to combining many assessment measures. Adverse events were rarely reported. Authors' conclusions: Therapist-supported ICBT appears to be an efficacious treatment for anxiety in adults. The evidence comparing therapist-supported ICBT to waiting list, attention, information, or online discussion group only control was low to moderate quality, the evidence comparing therapist-supported ICBT to unguided ICBT was very low quality, and comparisons of therapist-supported ICBT to face-to-face CBT were low quality. Further research is needed to better define and measure any potential harms resulting from treatment. These findings suggest that therapist-supported ICBT is more efficacious than a waiting list, attention, information, or online discussion group only control, and that there may not be a significant difference in outcome between unguided CBT and therapist-supported ICBT; however, this latter finding must be interpreted with caution due to imprecision. The evidence suggests that therapist-supported ICBT may not be significantly different from face-to-face CBT in reducing anxiety. Future research should explore heterogeneity among studies which is reducing the quality of the evidence body, involve equivalence trials comparing ICBT and face-to-face CBT, examine the importance of the role of the therapist in ICBT, and include effectiveness trials of ICBT in real-world settings. A timely update to this review is needed given the fast pace of this area of research.

The Cochrane database of systematic reviews · meta-analysis · 158 citationsread the source →

Metacognitive therapy versus cognitive-behavioural therapy in adults with generalised anxiety disorder.

Background: Cognitive-behavioural therapy (CBT) is the treatment of choice for generalised anxiety disorder (GAD), yielding significant improvements in approximately 50% of patients. There is significant room for improvement in the outcomes of treatment, especially in recovery. Aims: We aimed to compare metacognitive therapy (MCT) with the gold standard treatment, CBT, in patients with GAD (clinicaltrials.gov identifier: NCT00426426). Method: A total of 246 patients with long-term GAD were assessed and 81 were randomised into three conditions: CBT (n = 28), MCT (n = 32) and a wait-list control (n = 21). Assessments were made at pre-treatment, post-treatment and at 2 year follow-up. Results: Both CBT and MCT were effective treatments, but MCT was more effective (mean difference 9.762, 95% CI 2.679-16.845, P = 0.004) and led to significantly higher recovery rates (65% v. 38%). These differences were maintained at 2 year follow-up. Conclusions: MCT seems to produce recovery rates that exceed those of CBT. These results demonstrate that the effects of treatment cannot be attributed to non-specific therapy factors. Declaration of interest: A.W. wrote the treatment protocol in MCT and several books on CBT and MCT, and receives royalties from these. T.D.B. wrote the protocol in CBT and has published several articles and chapters on CBT and receives royalties from these. All other authors declare no competing interests.

BJPsych open · review · 57 citationsread the source →

Telemedicine Applications for Cancer Rehabilitation: Scoping Review.

Background: Cancer is a significant public health issue worldwide. Treatments such as surgery, chemotherapy, and radiation therapy often cause psychological and physiological side effects, affecting patients' ability to function and their quality of life (QoL). Physical activity is crucial to cancer rehabilitation, improving physical function and QoL and reducing cancer-related fatigue. However, many patients face barriers to accessing cancer rehabilitation due to socioeconomic factors, transportation issues, and time constraints. Telerehabilitation can potentially overcome these barriers by delivering rehabilitation remotely. Objective: The aim of the study is to identify how telemedicine is used for the rehabilitation of patients with cancer. Methods: This scoping review followed recognized frameworks. We conducted an electronic literature search on PubMed for studies published between January 2015 and May 2023. Inclusion criteria were studies reporting physical therapy telerehabilitation interventions for patients with cancer, including randomized and nonrandomized controlled trials, feasibility studies, and usability studies. In total, 21 studies met the criteria and were included in the final review. Results: Our search yielded 37 papers, with 21 included in the final review. Randomized controlled trials comprised 47% (n=10) of the studies, with feasibility studies at 33% (n=7) and usability studies at 19% (n=4). Sample sizes were typically 50 or fewer participants in 57% (n=12) of the reports. Participants were generally aged 65 years or younger (n=17, 81%), with a balanced gender distribution. Organ-specific cancers were the focus of 66% (n=14) of the papers, while 28% (n=6) included patients who were in the posttreatment period. Web-based systems were the most used technology (n=13, 61%), followed by phone call or SMS text messaging-based systems (n=9, 42%) and mobile apps (n=5, 23%). Exercise programs were mainly home based (n=19, 90%) and included aerobic (n=19, 90%), resistance (n=13, 61%), and flexibility training (n=7, 33%). Outcomes included improvements in functional capacity, cognitive functioning, and QoL (n=10, 47%); reductions in pain and hospital length of stay; and enhancements in fatigue, physical and emotional well-being, and anxiety. Positive effects on feasibility (n=3, 14%), acceptability (n=8, 38%), and cost-effectiveness (n=2, 9%) were also noted. Functional outcomes were frequently assessed (n=19, 71%) with tools like the 6-minute walk test and grip strength tests. Conclusions: Telerehabilitation for patients with cancer is beneficial and feasible, with diverse approaches in study design, technologies, exercises, and outcomes. Future research should focus on developing standardized methodologies, incorporating objective measures, and exploring emerging technologies like virtual reality, wearable or noncontact sensors, and artificial intelligence to optimize telerehabilitation interventions. Addressing these areas can enhance clinical practice and improve outcomes for remote rehabilitation with patients.

JMIR cancer · review · 17 citationsread the source →

Outcomes of Psychoeducation and a Text Messaging Adherence Intervention Among Individuals With Hypertension and Bipolar Disorder.

Objective: This study evaluated the feasibility, acceptability, and preliminary efficacy of psychoeducation plus an automated text messaging intervention (Individualized Texting for Adherence Building-Cardiovascular [iTAB-CV]) to improve adherence to antihypertensives and bipolar disorder medication. Methods: After a psychoeducation program, iTAB-CV was administered for 2 months. In month 1, participants received one educational-motivational and one mood rating text daily. In month 2, medication reminders were added. Results: The sample (N=38) was 74% African American and 53% women, with a mean±SD age of 51.53±9.06. Antihypertensive nonadherence decreased from a mean of 43%±23% to 21%±18% at 12 weeks (χ2=34.6, df=3, p<0.001). Systolic blood pressure decreased from a mean of 144.8±15.5 mmHg to 136.0±17.8 mmHg (χ2=17.6, df=3, p<.001). Retention was 100%. Conclusions: In this uncontrolled trial, participants were highly engaged and medication adherence and reduced systolic blood pressure were sustained after psychoeducation plus iTAB-CV. Because iTAB-CV is automated and delivered remotely, it has the potential to reach a large and challenging population.

Psychiatric services (Washington, D.C.) · clinical trial · 16 citationsread the source →

Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis.

Background: Dupilumab, a human monoclonal antibody against interleukin-4 receptor alpha, inhibits signaling of interleukin-4 and interleukin-13, type 2 cytokines that may be important drivers of atopic or allergic diseases such as atopic dermatitis. Methods: In two randomized, placebo-controlled, phase 3 trials of identical design (SOLO 1 and SOLO 2), we enrolled adults with moderate-to-severe atopic dermatitis whose disease was inadequately controlled by topical treatment. Patients were randomly assigned in a 1:1:1 ratio to receive, for 16 weeks, subcutaneous dupilumab (300 mg) or placebo weekly or the same dose of dupilumab every other week alternating with placebo. The primary outcome was the proportion of patients who had both a score of 0 or 1 (clear or almost clear) on the Investigator's Global Assessment and a reduction of 2 points or more in that score from baseline at week 16. Results: We enrolled 671 patients in SOLO 1 and 708 in SOLO 2. In SOLO 1, the primary outcome occurred in 85 patients (38%) who received dupilumab every other week and in 83 (37%) who received dupilumab weekly, as compared with 23 (10%) who received placebo (P<0.001 for both comparisons with placebo). The results were similar in SOLO 2, with the primary outcome occurring in 84 patients (36%) who received dupilumab every other week and in 87 (36%) who received dupilumab weekly, as compared with 20 (8%) who received placebo (P<0.001 for both comparisons). In addition, in the two trials, an improvement from baseline to week 16 of at least 75% on the Eczema Area and Severity Index was reported in significantly more patients who received each regimen of dupilumab than in patients who received placebo (P<0.001 for all comparisons). Dupilumab was also associated with improvement in other clinical end points, including reduction in pruritus and symptoms of anxiety or depression and improvement in quality of life. Injection-site reactions and conjunctivitis were more frequent in the dupilumab groups than in the placebo groups. Conclusions: In two phase 3 trials of identical design involving patients with atopic dermatitis, dupilumab improved the signs and symptoms of atopic dermatitis, including pruritus, symptoms of anxiety and depression, and quality of life, as compared with placebo. Trials of longer duration are needed to assess the long-term effectiveness and safety of dupilumab. (Funded by Sanofi and Regeneron Pharmaceuticals; SOLO 1 ClinicalTrials.gov number, NCT02277743 ; SOLO 2 ClinicalTrials.gov number, NCT02277769 .).

The New England journal of medicine · randomised controlled trial · 1521 citationsread the source →

Developing Behavioral Theory With the Systematic Integration of Community Social Capital Concepts.

Health behavior theories state that social environments influence health behaviors, but theories of how this occurs are relatively underdeveloped. This article systematically surveys community social capital concepts in health behavior literature and proposes a conceptual framework that integrates these concepts into existing behavioral theory. Fifty-three studies tested associations between community social capital concepts and physical activity (38 studies), smoking (19 studies), and diet (2 studies). Trustworthiness of community members was consistently associated with more health-promoting and less disease-promoting behaviors in 19 studies. Neighborly reciprocity showed mixed results in 10 studies. Reporting a good sense of community was associated with more physical activity in only 5 of 16 studies. Neighborhood collective efficacy, which includes social cohesion and informal social control, was inconsistently associated with behaviors in 22 studies. Behavioral social norms were associated with smoking and physical activity in 2 of 6 studies, and neighborhood modeling of physical activity was associated with increased activity in 12 of 17 studies, with 1 opposing result. This review identifies several community social capital-related concepts that are, at times, associated with both health-promoting and disease-promoting behaviors and often have no associations. Theory explains these findings by describing the relationships and interactions among these concepts. Using these findings, this article proposes a conceptual framework that integrates community social capital concepts into existing behavioral theory. Iterative empirically based theory development is needed to address these concepts, which affect behaviors. These results can also inform theoretically based community-based and socially tailored interventions.

Health education & behavior : the official publication of the Society for Public Health Education · review · 28 citationsread the source →

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

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

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

Social inequalities in multimorbidity, frailty, disability, and transitions to mortality: a 24-year follow-up of the Whitehall II cohort study.

Background: Social inequalities in mortality persist in high-income countries with universal health care, and the mechanisms by which these inequalities are generated remain unclear. We aimed to examine whether social inequalities were present before or after the onset of adverse health conditions (multimorbidity, frailty, and disability). Methods: Our analysis was based on data from the ongoing Whitehall II cohort study, which enrolled British civil servants aged 35-55 years in 1985-88. Participants were assessed for three indicators of socioeconomic status (education, occupational position, and literacy) at age 50 years. Participants underwent clinical examinations (in 2002-04, 2007-09, 2012-13, and 2015-16) for assessment of frailty (two or more of low physical activity, slow walking speed, poor grip strength, weight loss, and exhaustion) and disability (two or more difficulties in bathing, dressing, going to the toilet, transferring, feeding, and walking). In addition, electronic health records were used to assess the incidence of multimorbidity (two or more of diabetes, coronary heart disease, stroke, chronic obstructive pulmonary disease, depression, arthritis, cancer, dementia, and Parkinson's disease) and mortality. In analyses adjusted for sociodemographic factors, we used multistate models to examine social inequalities in transitions from healthy state to adverse health conditions and subsequently to mortality. Findings: Of 10 308 individuals in the Whitehall II study cohort, 6425 had relevant data available at 50 years and to the end of follow-up on Aug 31, 2017, and were included in our analysis. Participants were followed up for a median of 23·6 years (IQR 19·6-28·9). 1694 (26·4%) of 6425 participants developed multimorbidity, 1733 (27·0%) became frail, 692 (10·8%) had a disability, and 611 (9·5%) died. Multimorbidity (hazard ratio [HR] 4·12 [95% CI 3·41-4·98]), frailty (HR 2·38 [95% CI 1·93-2·93]), and disability (HR 1·73 [95% CI 1·34-2·22]) were associated with increased risk of mortality; these associations were not modified by socioeconomic status. In multistate models, occupation was the socioeconomic status indicator that was most strongly associated with inequalities in the transition from healthy state to multimorbidity (HR 1·54 [95% CI 1·37-1·73]), to frailty (HR 2·08 [95% CI 1·85-2·33]), and to disability (HR 1·44 [95% CI 1·18-1·74]). Socioeconomic status indicators did not affect transitions to mortality in those with multimorbidity, frailty, or disability. Interpretation: Socioeconomic status affects the risk of multimorbidity, frailty, and disability, but does not affect the risk of mortality after the onset of these adverse health conditions. Therefore, primary prevention is key to reducing social inequalities in mortality. Of the three adverse health conditions, multimorbidity had the strongest association with mortality, making it a central target for improving population health. Funding: UK Medical Research Council; National Institute on Aging, National Institutes of Health; British Heart Foundation.

The Lancet. Public health · 239 citationsread the source →

Latine mothers' conceptions of bien educado in U.S. Latine adolescents: Respect, humility, good manners, and consideration for others as Core aspects.

Developmental theories of ethnocultural socialization (Incorporating the cultural value of respeto into a framework of Latino parenting. Cultural Diversity and Ethnic Minority Psychology, 16(1), 77-86; Traditional and culture-specific parenting of prosociality in U.S. Latino/as. Oxford handbook of parenting and moral development, Oxford University Press.) emphasize the importance of understanding how caregivers instill culturally grounded values adapted to specific cultural and environmental contexts to support positive youth development. Caregivers are deemed to transmit these cultural values to their youth via ethnic heritage practices, customs, rituals, and cultural experiences. Importantly, work based on these models has shown that specific cultural values significantly predict the health and well-being of Latine youth (Cultural values, empathy, and prosocial behavior among U.S. Latino/a youth: A mediation model. Journal of Social and Personal Relationships, 38(2), 521-540; Familism values and adjustment among Hispanic/Latino individuals: A systematic review and meta-analysis. Psychological Bulletin, 147(9), 947-985). Among the cultural values instilled by many Latine parents is bien educado, a concept that emphasizes the importance that youth be well-mannered, display positive social behaviors, and exhibit a strong moral character (Familismo, respeto, and bien educado: Traditional/cultural models and values in Latinos. Critical Cultural Studies of Childhood. Springer). While much of the prior research has focused on cultural values such as familismo and respeto, relatively little is known about the cultural value of bien educado. Indeed, no studies exist on how bien educado is conceptualized and taught by Latine mothers. To address this gap, focus group interviews were conducted to explore how Latine mothers of adolescents define and teach bien educado to their adolescents. Seventeen Latine mothers (Mage = 41.88 years, SD = 6.23) reporting on their adolescents (Mage = 14.97 years, SD = 3.55) participated. On average, mothers had two children and lived in the United States for approximately 21.6 years. The majority were of Mexican origin and predominantly Spanish-speaking (88%). Focus group interviews were conducted in Spanish and English using semi-structured questions designed to explore mothers' definitions, beliefs, and practices related to bien educado. The questions included: "What is your own definition of bien educado?" and "What are some things you do to teach your child to be bien educado?" All focus groups were audio-recorded, transcribed verbatim, and trained; bilingual coders analyzed the transcripts using inductive thematic analysis (Qualitative inquiry and research design: Choosing among five approaches. SAGE Publications). Mothers conceptualized bien educado as encompassing four main aspects: respect, consideration for others, humility, and being well-mannered. Furthermore, mothers emphasized their intentionality to foster these traits in their youth and viewed the concept as a strength-based approach that contributed positively to their youth's moral development. The findings reveal that bien educado is a multidimensional cultural value construct and a Latine culturally-relevant parenting goal. Specifically, the findings highlight the central elements of bien educado as respect, consideration for others, being well-mannered, and humility. Given the centrality of these four elements in prosocial and moral development (The development and correlates of prosocial moral behaviors. Handbook of moral development. Psychology Press.), the present findings situate bien educado as a Latine-grounded value that can further our understanding of U.S. Latine youth prosocial and moral development. Moreover, the findings demonstrate the need to incorporate this understudied core Latine cultural value into sociocultural- and ecological-grounded parental socialization models and future research in U.S. Latine youth.

Journal of research on adolescence : the official journal of the Society for Research on Adolescenceread the source →

Association between the Munich Chronotype Questionnaire and Wrist Actigraphy.

Chronotype refers to individuals' preferences for timing of sleep and wakefulness. It can be quantified by measuring the midpoint time between the start and end of sleep during free days. Measuring chronotype is helpful to diagnose circadian rhythm sleep-wake disorders. The Munich Chronotype Questionnaire (MCTQ) is a self-reported measure of chronotype that calculates the midpoint of sleep on free days based on self-reported bed and wake times. Self-reports of sleep are prone to bias. The objective was to examine the agreement between the MCTQ-derived midpoint and an objective measure obtained using wrist actigraphy. The sleep of 115 participants aged 18-34 (mean = 24, SD = 4.6) was monitored with actigraphy for 4 to 6 consecutive nights. The corrected midpoint of sleep on free days was derived from sleep start and end times on both free days and scheduled days. The corrected midpoint of sleep on free days as measured by the MCTQ was 4:56 (SD = 1 : 16) and by actigraphy was 4:51 (SD = 1 : 23). They were not significantly different (t(87) = 0.66, p = 0.51). A strong correlation was found between these two measurements (r(88) = 0.73, p < 0.001). The 95% limits of agreement were between -1:37:19 and 2:14:38. MCTQ and actigraphy provide similar results for the corrected midpoint of sleep on free days.

Sleep disorders · 66 citationsread the source →

'I am a father but not pregnant': a qualitative analysis of the perspectives of pregnant couples on male partner role during pregnancy care in Bamenda, Cameroon.

Background: The reduction of maternal mortality has stagnated globally. Estimates project a rise to 140.9 deaths per 100,000 live births by 2030, which is double the Sustainable Development Goal target. Male involvement in pregnancy care has been proposed as an intervention to improve maternal and child health outcomes. However, there is limited understanding of how communities view the role of men beyond the instrumentalist approach that only targets men as accompanying partners without altering the underlying gender and socio-cultural determinants that shape their involvement in pregnancy care. This study broadens existing research by exploring and and contextualising the role of male partners during pregnancy in Bamenda, Cameroon. Methods: This study employed a qualitative design underpinned by symbolic interactionism. We conducted 68 semi-structured interviews (SSIs) and three focus group discussions (FGDs) with purposively selected pregnant women (n = 38 SSIs; n = 2, FGD) and male partners (n = 30 SSIs; n = 1, FGD) in an urban hospital in the North West Regional capital-Bamenda. Nvivo was used for data management and subsequently, we performed thematic analysis using a critical discourse lens to generate manifest and latent interpretations of study findings. Results: The role of male partners reflected hegemonic masculinity and was broadly conceptualised in three categories: breadwinner, protector/comforter, and 'sender' for antenatal care. Perceptions of men's role differed between male and female participants. While women sought male involvement for pragmatic reasons like joint attendance of antenatal care, psychosocial support (affirmation) and assistance with domestic chores, men limited their involvement to roles that matched gendered preconceptions of masculinity like financial support for antenatal fees, maternal nutrition and birth supplies. Nonetheless, the perceived benefits for antenatal attendance was expressed by some men in terms of the direct access it gives them to pregnancy-related education from experts, paternal bonding and the appeal of fast-track services for couples. Conclusion: Male involvement in maternal and child health in Bamenda Health District is an extension and reflection of how patriarchal norms on masculinity are constructed and adapted in this setting. To address gaps in male involvement, intervention designers and implementers will need to take into account prevailing culture-specific norms while deconstructing and leveraging masculine ideals to situate male involvement in the prenatal context.

Reproductive health · 3 citationsread the source →

The profile of psychiatric symptoms exacerbated by methamphetamine use.

Background: Methamphetamine use can produce symptoms almost indistinguishable from schizophrenia. Distinguishing between the two conditions has been hampered by the lack of a validated symptom profile for methamphetamine-induced psychiatric symptoms. We use data from a longitudinal cohort study to examine the profile of psychiatric symptoms that are acutely exacerbated by methamphetamine use. Methods: 164 methamphetamine users, who did not meet DSM-IV criteria for a lifetime primary psychotic disorder, were followed monthly for one year to assess the relationship between days of methamphetamine use and symptom severity on the 24-item Brief Psychiatric Rating Scale. Exacerbation of psychiatric symptoms with methamphetamine use was quantified using random coefficient models. The dimensions of symptom exacerbation were examined using principal axis factoring and a latent profile analysis. Results: Symptoms exacerbated by methamphetamine loaded on three factors: positive psychotic symptoms (suspiciousness, unusual thought content, hallucinations, bizarre behavior); affective symptoms (depression, suicidality, guilt, hostility, somatic concern, self-neglect); and psychomotor symptoms (tension, excitement, distractibility, motor hyperactivity). Methamphetamine use did not significantly increase negative symptoms. Vulnerability to positive psychotic and affective symptom exacerbation was shared by 28% of participants, and this vulnerability aligned with a past year DSM-IV diagnosis of substance-induced psychosis (38% vs. 22%, χ(2)(df1)=3.66, p=0.056). Conclusion: Methamphetamine use produced a symptom profile comprised of positive psychotic and affective symptoms, which aligned with a diagnosis of substance-induced psychosis, with no evidence of a negative syndrome.

Drug and alcohol dependence · 55 citationsread the source →

Implementing innovative evidence-based perinatal mental health screening for women of refugee background.

Problem: National guidelines recommend repeated screening for depression and anxiety for all women in the perinatal period. Routine screening in pregnancy is limited due to service, community and individual barriers. Background: Perinatal depression and perinatal anxiety affect up to 20% of all women. Women of refugee background are at even greater risk for perinatal mental health conditions due to refugee experiences and resettlement stressors. Aim: To evaluate the acceptability and feasibility of a perinatal mental health screening program for women of refugee background from the perspective of health professionals. Methods: A mixed methods design guided by the Normalization Process Theory was used. Data were collected at a dedicated refugee antenatal clinic in the south-eastern suburbs of Melbourne, Australia. An online survey (n=38), focus groups (n=2; 13 participants) and semi-structured interviews (n=8; 11 participants) with health professionals were conducted. Findings: Under the four constructs of the Normalization Process Theory, health professionals reported improvements in identifying and referring women with mental health issues, more open and in-depth conversations with women about mental health and valued using an evidenced-based measure. Key issues included professional development, language barriers and time constraints. Discussion: Implementing a perinatal mental health screening program has been positively received. Strategies for sustainability include professional development and the addition of audio versions of the measures. Conclusion: This perinatal mental health screening program is acceptable and a feasible option for health professionals. Health professionals value providing more holistic care and have more open discussion with women about mental health.

Women and birth : journal of the Australian College of Midwives · 24 citationsread the source →

Childhood maltreatment and unfavourable clinical outcomes in bipolar disorder: a systematic review and meta-analysis.

Background: Bipolar disorder affects up to one in 25 individuals and identification of early risk indicators of negative outcomes could facilitate early detection of patients with greatest clinical needs and risk. We aimed to investigate the association between childhood maltreatment and key negative outcomes in patients with bipolar disorder. Methods: For this systematic review and meta-analysis we searched MEDLINE, PsycINFO, and Embase to identify articles published before Jan 1, 2015, examining the association of maltreatment (physical, sexual, or emotional abuse, neglect, or family conflict) before age 18 years with clinical features and course of illness in bipolar disorder. Data were extracted from published reports and any missing information was requested from investigators. We did 12 independent random-effects meta-analyses to quantify the associations between childhood maltreatment and course of illness or clinical features. Findings: We initially identified 527 records and after unsuitable studies were removed, our search yielded 148 publications of which 30 were used in the meta-analysis. Patients with bipolar disorder and history of childhood maltreatment had greater mania severity (six studies, 780 participants; odds ratio [OR] 2·02, 95% CI 1·21-3·39, p=0·008), greater depression severity (eight studies, 1007 participants; 1·57, 1·25-1·99, p=0·0001), greater psychosis severity (seven studies, 1494 participants; 1·49, 1·10-2·04, p=0·011), higher risk of comorbidity with post-traumatic stress disorder (eight studies, 2494 participants; 3·60, 2·45-5·30, p<0·0001), anxiety disorders (seven studies, 5091 participants; 1·90, 1·39-2·61, p<0·0001), substance misuse disorders (11 studies, 5469 participants; 1·84, 1·41-2·39, p<0·0001), alcohol misuse disorder (eight studies, 5040 participants; 1·44, 1·13-1·83, p=0·003), earlier age of bipolar disorder onset (14 studies, 5733 participants; 1·85, 1·43-2·40, p<0·0001), higher risk of rapid cycling (eight studies, 3010 participants; 1·89, 1·45-2·48, p<0·0001), greater number of manic episodes (seven studies, 3909 participants; 1·26, 1·09-1·47, p=0·003), greater number of depressive episodes (eight studies, 4025 participants; 1·38, 1·07-1·79, p=0·013), and higher risk of suicide attempt (13 studies, 3422 participants; 2·25, 1·88-2·70, p<0·0001) compared with those with bipolar disorder without childhood maltreatment. Overall, these associations were not explained by publication bias, undue effects of individual studies, or variation in study quality. Interpretation: Childhood maltreatment predicts unfavourable clinical features and course of illness in patients with bipolar disorder. Funding: None.

The lancet. Psychiatry · meta-analysis · 278 citationsread the source →

Catastrophizing, pain, and functional outcomes for children with chronic pain: a meta-analytic review.

Pediatric chronic pain is associated with numerous negative outcomes including increased physical disability, increased rates of depression and anxiety, and decreased quality of life (QOL). Pain catastrophizing-broadly conceptualized as including rumination, magnification, and helplessness cognitions surrounding one's pain-has been linked with poor functional outcomes in children with chronic pain. Pain catastrophizing in pediatric chronic pain is often considered a key factor on which to focus treatment efforts. However, absent a systematic review that integrates the relevant literature, this call for routine assessment and targeted treatment may be premature. This study aimed to: (1) meta-analytically quantify the relationship between catastrophizing and pain and functional/psychosocial outcomes (functional disability/physical functioning, anxiety, depression, and QOL) in children with chronic pain, and (2) examine potential moderators of these relationships. Using a random-effects model, a total of 111 effect sizes from 38 studies were analyzed. Effect sizes ranged from medium to large, with anxiety, depression, and QOL demonstrating a strong association with catastrophizing. Pain intensity and physical disability had a moderate association with catastrophizing. These relationships were robust, minimizing potential publication bias. None of the examined moderators were significant. The strong relationships found between catastrophizing and anxiety, depression, and QOL suggest that successfully intervening on catastrophizing could have far reaching implications in improving pain outcomes in pediatric chronic pain.

Pain · meta-analysis · 60 citationsread the source →

Time-varying associations of pre-migration and post-migration stressors in refugees' mental health during resettlement: a longitudinal study in Australia.

Background: Understanding the time-varying association of pre-migration and post-migration stressors in refugees' mental health could help in designing tailored health promotion services at different resettlement stages and improving the efficiency of resource allocation. In this study, we explored these time-varying associations. Methods: We used data from the first four waves (October, 2013, to February, 2017) of a national refugee-based longitudinal study, the Building a New Life in Australia (BNLA) project. Post-traumatic stress disorder (PTSD) and high risk of severe mental illness (HR-SMI) were used to assess mental health. The independent variables included the number of potentially traumatic events experienced during the pre-migration process, and a range of post-migration stressors. We used logistic regression models to analyse the relative importance of variables and time-varying associations between the pre-migration potentially traumatic events, post-migration resettlement stressors, and refugees' mental health. Analyses were stratified by gender, and sociodemographic covariates included age, marital status, education level, country of birth, and weekly income. Results: 2399 participants were surveyed in Wave 1 of the BNLA project in 2013-14, of whom 2009 (83·7%) responded in Wave 2 in 2014-15, 1894 (78·9%) in Wave 3 in 2015-16, and 1929 (80·4%) in Wave 4 in 2016-17. The three most important factors associated with mental health in each wave differed for male and female refugees, but the socioeconomic stressors of loneliness and adjustment to life in Australia were consistently prominent. Positive associations between socioeconomic stressors and mental ill-health were found for both genders, with a peak at Wave 2 (adjusted odds ratio [AOR] among men, 1·60 [95% CI 1·26-2·03], p=0.0001 for PTSD; AOR 1·86 [1·35-2·55], p=0·0001 for HR-SMI; and among women, AOR 1·81 [1·27-2·57], p=0·0009 for PTSD; AOR 2·24 [1·49-3·38], p=0·0001 for HR-SMI). Associations between loneliness and mental health fluctuated, but were significant for both genders in Wave 4 (among men, AOR 1·90 [1·21-2·99], p=0·0051 for PTSD; AOR 3·70 [2·18-6·27], p<0·0001 for HR-SMI; and among women, AOR 3·65 [2·08-6·39], p<0·0001 for PTSD; AOR 3·68 [2·02-6·69], p<0·0001 for HR-SMI). The association between difficulties in adjustment to life in Australia and male refugees' mental ill-health increased continuously during the resettlement period. Interpretation: Gender-specific and time-sensitive services should be considered to improve refugees' mental health. For both genders, improved economic conditions that complement social security benefits deserve attention and are relevant throughout the resettlement process. At the later stage of resettlement, services to reduce loneliness could be carried out, and reducing stressors related to adjustment to life in the host country is especially needed for male refugees. Funding: None.

The lancet. Psychiatry · 63 citationsread the source →

Interactive telemedicine: effects on professional practice and health care outcomes.

Background: Telemedicine (TM) is the use of telecommunication systems to deliver health care at a distance. It has the potential to improve patient health outcomes, access to health care and reduce healthcare costs. As TM applications continue to evolve it is important to understand the impact TM might have on patients, healthcare professionals and the organisation of care. Objectives: To assess the effectiveness, acceptability and costs of interactive TM as an alternative to, or in addition to, usual care (i.e. face-to-face care, or telephone consultation). Search methods: We searched the Effective Practice and Organisation of Care (EPOC) Group's specialised register, CENTRAL, MEDLINE, EMBASE, five other databases and two trials registers to June 2013, together with reference checking, citation searching, handsearching and contact with study authors to identify additional studies. Selection criteria: We considered randomised controlled trials of interactive TM that involved direct patient-provider interaction and was delivered in addition to, or substituting for, usual care compared with usual care alone, to participants with any clinical condition. We excluded telephone only interventions and wholly automatic self-management TM interventions. Data collection and analysis: For each condition, we pooled outcome data that were sufficiently homogenous using fixed effect meta-analysis. We reported risk ratios (RR) and 95% confidence intervals (CI) for dichotomous outcomes, and mean differences (MD) for continuous outcomes. Main results: We included 93 eligible trials (N = 22,047 participants), which evaluated the effectiveness of interactive TM delivered in addition to (32% of studies), as an alternative to (57% of studies), or partly substituted for usual care (11%) as compared to usual care alone. The included studies recruited patients with the following clinical conditions: cardiovascular disease (36), diabetes (21), respiratory conditions (9), mental health or substance abuse conditions (7), conditions requiring a specialist consultation (6), co morbidities (3), urogenital conditions (3), neurological injuries and conditions (2), gastrointestinal conditions (2), neonatal conditions requiring specialist care (2), solid organ transplantation (1), and cancer (1).Telemedicine provided remote monitoring (55 studies), or real-time video-conferencing (38 studies), which was used either alone or in combination. The main TM function varied depending on clinical condition, but fell typically into one of the following six categories, with some overlap: i) monitoring of a chronic condition to detect early signs of deterioration and prompt treatment and advice, (41); ii) provision of treatment or rehabilitation (12), for example the delivery of cognitive behavioural therapy, or incontinence training; iii) education and advice for self-management (23), for example nurses delivering education to patients with diabetes or providing support to parents of very low birth weight infants or to patients with home parenteral nutrition; iv) specialist consultations for diagnosis and treatment decisions (8), v) real-time assessment of clinical status, for example post-operative assessment after minor operation or follow-up after solid organ transplantation (8) vi), screening, for angina (1).The type of data transmitted by the patient, the frequency of data transfer, (e.g. telephone, e-mail, SMS) and frequency of interactions between patient and healthcare provider varied across studies, as did the type of healthcare provider/s and healthcare system involved in delivering the intervention. We found no difference between groups for all-cause mortality for patients with heart failure (16 studies; N = 5239; RR:0.89, 95% CI 0.76 to 1.03, P = 0.12; I(2) = 44%) (moderate to high certainty of evidence) at a median of six months follow-up. Admissions to hospital (11 studies; N = 4529) ranged from a decrease of 64% to an increase of 60% at median eight months follow-up (moderate certainty of evidence). We found some evidence of improved quality of life (five studies; N = 482; MD:-4.39, 95% CI -7.94 to -0.83; P < 0.02; I(2) = 0%) (moderate certainty of evidence) for those allocated to TM as compared with usual care at a median three months follow-up. In studies recruiting participants with diabetes (16 studies; N = 2768) we found lower glycated haemoglobin (HbA1c %) levels in those allocated to TM than in controls (MD -0.31, 95% CI -0.37 to -0.24; P < 0.00001; I(2)= 42%, P = 0.04) (high certainty of evidence) at a median of nine months follow-up. We found some evidence for a decrease in LDL (four studies, N = 1692; MD -12.45, 95% CI -14.23 to -10.68; P < 0.00001; I(2 =) 0%) (moderate certainty of evidence), and blood pressure (four studies, N = 1770: MD: SBP:-4.33, 95% CI -5.30 to -3.35, P < 0.00001; I(2) = 17%; DBP: -2.75 95% CI -3.28 to -2.22, P < 0.00001; I(2) = 45% (moderate certainty evidence), in TM as compared with usual care. Seven studies that recruited participants with different mental health and substance abuse problems, reported no differences in the effect of therapy delivered over video-conferencing, as compared to face-to-face delivery. Findings from the other studies were inconsistent; there was some evidence that monitoring via TM improved blood pressure control in participants with hypertension, and a few studies reported improved symptom scores for those with a respiratory condition. Studies recruiting participants requiring mental health services and those requiring specialist consultation for a dermatological condition reported no differences between groups. Authors' conclusions: The findings in our review indicate that the use of TM in the management of heart failure appears to lead to similar health outcomes as face-to-face or telephone delivery of care; there is evidence that TM can improve the control of blood glucose in those with diabetes. The cost to a health service, and acceptability by patients and healthcare professionals, is not clear due to limited data reported for these outcomes. The effectiveness of TM may depend on a number of different factors, including those related to the study population e.g. the severity of the condition and the disease trajectory of the participants, the function of the intervention e.g., if it is used for monitoring a chronic condition, or to provide access to diagnostic services, as well as the healthcare provider and healthcare system involved in delivering the intervention.

The Cochrane database of systematic reviews · meta-analysis · 456 citationsread the source →

Prevalence of depression, anxiety, and insomnia among healthcare workers during the COVID-19 pandemic: A systematic review and meta-analysis.

Background: COVID-19 pandemic has the potential to significantly affect the mental health of healthcare workers (HCWs), who stand in the frontline of this crisis. It is, therefore, an immediate priority to monitor rates of mood, sleep and other mental health issues in order to understand mediating factors and inform tailored interventions. The aim of this review is to synthesize and analyze existing evidence on the prevalence of depression, anxiety and insomnia among HCWs during the Covid-19 outbreak. Methods: A systematic search of literature databases was conducted up to April 17th, 2020. Two reviewers independently assessed full-text articles according to predefined criteria. Risk of bias for each individual study was assessed and data pooled using random-effects meta-analyses to estimate the prevalence of specific mental health problems. The review protocol is registered in PROSPERO and is available online. Findings: Thirteen studies were included in the analysis with a combined total of 33,062 participants. Anxiety was assessed in 12 studies, with a pooled prevalence of 23·2% and depression in 10 studies, with a prevalence rate of 22·8%. A subgroup analysis revealed gender and occupational differences with female HCPs and nurses exhibiting higher rates of affective symptoms compared to male and medical staff respectively. Finally, insomnia prevalence was estimated at 38·9% across 5 studies. Interpretation: Early evidence suggests that a considerable proportion of HCWs experience mood and sleep disturbances during this outbreak, stressing the need to establish ways to mitigate mental health risks and adjust interventions under pandemic conditions.

Brain, behavior, and immunity · meta-analysis · 2357 citationsread the source →

Non-pharmacological interventions for treating chronic prostatitis/chronic pelvic pain syndrome.

Background: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common disorder in which the two main clinical features are pelvic pain and lower urinary tract symptoms. There are currently many approaches for its management, using both pharmacological and non-pharmacological interventions. The National Institute of Health - Chronic Prostatitis Symptom Index (NIH-CPSI) score is a validated measure commonly used to measure CP/CPPS symptoms. Objectives: To assess the effects of non-pharmacological therapies for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Search methods: We performed a comprehensive search using multiple databases, trial registries, grey literature and conference proceedings with no restrictions on the language of publication or publication status. The date of the latest search of all databases was August 2017. Selection criteria: We included randomised controlled trials. Inclusion criteria were men with a diagnosis of CP/CPPS. We included all available non-pharmacological interventions. Data collection and analysis: Two review authors independently classified studies and abstracted data from the included studies, performed statistical analyses and rated quality of evidence (QoE) according to the GRADE methods. Main results: We included 38 unique studies with 3290 men with CP/CPPS across 23 comparisons.1. Acupuncture: (three studies, 204 participants) based on short-term follow-up, acupuncture reduces prostatitis symptoms in an appreciable number of participants compared with sham procedure (mean difference (MD) in total NIH-CPSI score -5.79, 95% confidence interval (CI) -7.32 to -4.26, high QoE). Acupuncture likely results in little to no difference in adverse events (moderate QoE). It probably also decreases prostatitis symptoms compared with standard medical therapy in an appreciable number of participants (MD -6.05, 95% CI -7.87 to -4.24, two studies, 78 participants, moderate QoE).2. Circumcision: (one study, 713 participants) based on short-term follow-up, early circumcision probably decreases prostatitis symptoms slightly (NIH-CPSI score MD -3.00, 95% CI -3.82 to -2.18, moderate QoE) and may not be associated with a greater incidence of adverse events compared with control (a waiting list to be circumcised, low QoE).3. Electromagnetic chair: (two studies, 57 participants) based on short-term follow-up, we are uncertain of the effects of the use of an electromagnetic chair on prostatitis symptoms. It may be associated with a greater incidence of adverse events compared with sham procedure (low to very low QoE).4. Lifestyle modifications: (one study, 100 participants) based on short-term follow-up, lifestyle modifications may be associated with a greater improvement in prostatitis symptoms in an appreciable number of participants compared with control (risk ratio (RR) for improvement in NIH-CPSI scores 3.90, 95% CI 2.20 to 6.92, very low QoE). We found no information regarding adverse events.5. Physical activity: (one study, 85 participants) based on short-term follow-up, a physical activity programme may cause a small reduction in prostatitis symptoms compared with control (NIH-CPSI score MD -2.50, 95% CI -4.69 to -0.31, low QoE). We found no information regarding adverse events.6. Prostatic massage: (two studies, 115 participants) based on short-term follow-up, we are uncertain whether the prostatic massage reduces or increases prostatitis symptoms compared with control (very low QoE). We found no information regarding adverse events.7. Extracorporeal shockwave therapy: (three studies, 157 participants) based on short-term follow-up, extracorporeal shockwave therapy reduces prostatitis symptoms compared with control (NIH-CPSI score MD -6.18, 95% CI -7.46 to -4.89, high QoE). These results may not be sustained at medium-term follow-up (low QoE). This treatment may not be associated with a greater incidence of adverse events (low QoE).8. Transrectal thermotherapy compared to medical therapy: (two studies, 237 participants) based on short-term follow-up, transrectal thermotherapy alone or in combination with medical therapy may decrease prostatitis symptoms slightly when compared with medical therapy alone (NIH-CPSI score MD -2.50, 95% CI -3.82 to -1.18, low QoE). One included study reported that participants may experience transient adverse events.9. Other interventions: there is uncertainty about the effects of other interventions included in this review. We found no information regarding psychological support or prostatic surgery. Authors' conclusions: Some of the interventions can decrease prostatitis symptoms in an appreciable number without a greater incidence of adverse events. The QoE was mostly low. Future clinical trials should include a full report of their methods including adequate masking, consistent assessment of all patient-important outcomes including potential treatment-related adverse events and appropriate sample sizes.

The Cochrane database of systematic reviews · meta-analysis · 19 citationsread the source →

Mobile phone SMS messages can enhance healthy behaviour: a meta-analysis of randomised controlled trials.

Healthy behaviour, such as smoking cessation and adherence to prescribed medications, mitigates illness risk factors but health behaviour change can be challenging. Mobile phone short-message service (SMS) messages are increasingly used to deliver interventions designed to enhance healthy behaviour. This meta-analysis used a random-effects model to synthesise 38 randomised controlled trials that investigated the efficacy of SMS messages to enhance healthy behaviour. Participants (N = 19,641) lived in developed and developing countries and were diverse with respect to age, ethnicity, socioeconomic background and health behaviours targeted for change. SMS messages had a small, positive, significant effect (g = 0.291) on a broad range of healthy behaviour. This effect was maximised when multiple SMS messages per day were used (g = 0.395) compared to using lower frequencies (daily, multiple per week and once-off) (g = 0.244). The low heterogeneity in this meta-analysis (I (2) = 38.619) supports reporting a summary effect size and implies that the effect of SMS messaging is robust, regardless of population characteristics or healthy behaviour targeted. SMS messaging is a simple, cost-effective intervention that can be automated and can reach any mobile phone owner. While the effect size is small, potential health benefits are well worth achieving.

Health psychology review · meta-analysis · 112 citationsread the source →

Global prevalence of mental health problems among healthcare workers during the Covid-19 pandemic: A systematic review and meta-analysis.

Background: Healthcare workers are at high risk of developing mental health issues during the coronavirus disease 2019 (COVID-19) pandemic. However, there is a need for a full picture of mental health problems with comprehensive analysis among healthcare workers during the COVID-19 pandemic. Objective: This review aimed to systematically identify the mental health problems among healthcare workers in various countries during the COVID-19 pandemic. Design: Systematic review and meta-analysis. Methods: A systematic literature search was performed of the following databases: PubMed, Academic Search Complete, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Web of Science, MEDLINE Complete, and SocINDEX. The last date of our search was November 2, 2020. We included all cohort, case-control and cross-sectional studies and used the Joanna Briggs Institute tool to assess their quality. A meta-analysis was performed to synthesize the pooled prevalence of mental health problems using a random-effects model. Heterogeneity was measured using the I2 statistic and Egger's test was used to assess publication bias. Results: A total of 38 studies were identified that reported the mental health problems of healthcare workers during the COVID-19 pandemic. The distribution of healthcare workers analyzed in this review included 27.9% doctors, 43.7% nurses, and 7.0% allied health workers. The pooled prevalence of mental health problems for post-traumatic stress disorder, anxiety, depression, and distress was 49% (95% confidence interval [CI]: 22-75%), 40% (95% CI: 29-52%), 37% (95% CI: 29-45%), and 37% (95% CI: 25-50%), respectively. Conclusion: This review yielded evidence that estimated the global prevalence of mental health problems among healthcare workers during the COVID-19 pandemic. Post-traumatic stress disorder was the most common mental health disorder reported by healthcare workers during the COVID-19 pandemic, followed by anxiety, depression, and distress. Additional studies remain necessary to assess the appropriate management strategies for treating and preventing mental health disorders among healthcare workers during the pandemic.

International journal of nursing studies · meta-analysis · 281 citationsread the source →

Factors Associated With Post-Stroke Physical Activity: A Systematic Review and Meta-Analysis.

Objective: To integrate the literature investigating factors associated with post-stroke physical activity. Data sources: A search was conducted from database inception to June 2016 across 9 databases: Cochrane, MEDLINE, ProQuest, Web of Science, PsycINFO, Scopus, Embase, CINAHL, and Allied and Complementary Medicine Database. The reference lists of included articles were screened for secondary literature. Study selection: Cohort and cross-sectional studies were included if they recruited community-dwelling stroke survivors and measured factors associated with physical activity. Data extraction: Risk of bias was evaluated using the Quality in Prognosis Studies checklist. A meta-analysis was conducted for correlates where there were at least 2 studies that reported a correlation value. Correlation values were used in an effect size measure and converted to a standardized unit with Fisher r to z transformation and conversion back to r method. Results were described qualitatively for studies that could not be pooled. Data synthesis: There were 2161 studies screened and 26 studies included. Age (meta r=-.17; P≤.001) and sex (meta r=-.01; P=.02) were the nonmodifiable factors that were found to be associated with post-stroke physical activity. The modifiable factors were physical function (meta r=.68-.73; P<.001), cardiorespiratory fitness (meta r=.35; P≤.001), fatigue (meta r=-.22; P=.01), falls self-efficacy (meta r=-.33; P<.001), balance self-efficacy (meta r=.37; P<.001), depression (meta r=-.58 to .48; P<.001), and health-related quality of life (meta r=.38-.43; P<.001). The effect of side of infarct, neglect, and cognition on post-stroke physical activity was inconclusive. Conclusions: Age, sex, physical function, depression, fatigue, self-efficacy, and quality of life were factors associated with post-stroke physical activity. The cause and effect of these relations are unclear, and the possibility of reverse causality needs to be addressed.

Archives of physical medicine and rehabilitation · meta-analysis · 223 citationsread the source →

Effectiveness of brief alcohol interventions in primary care populations.

Background: Excessive drinking is a significant cause of mortality, morbidity and social problems in many countries. Brief interventions aim to reduce alcohol consumption and related harm in hazardous and harmful drinkers who are not actively seeking help for alcohol problems. Interventions usually take the form of a conversation with a primary care provider and may include feedback on the person's alcohol use, information about potential harms and benefits of reducing intake, and advice on how to reduce consumption. Discussion informs the development of a personal plan to help reduce consumption. Brief interventions can also include behaviour change or motivationally-focused counselling. This is an update of a Cochrane Review published in 2007. Objectives: To assess the effectiveness of screening and brief alcohol intervention to reduce excessive alcohol consumption in hazardous or harmful drinkers in general practice or emergency care settings. Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and 12 other bibliographic databases to September 2017. We searched Alcohol and Alcohol Problems Science Database (to December 2003, after which the database was discontinued), trials registries, and websites. We carried out handsearching and checked reference lists of included studies and relevant reviews. Selection criteria: We included randomised controlled trials (RCTs) of brief interventions to reduce hazardous or harmful alcohol consumption in people attending general practice, emergency care or other primary care settings for reasons other than alcohol treatment. The comparison group was no or minimal intervention, where a measure of alcohol consumption was reported. 'Brief intervention' was defined as a conversation comprising five or fewer sessions of brief advice or brief lifestyle counselling and a total duration of less than 60 minutes. Any more was considered an extended intervention. Digital interventions were not included in this review. Data collection and analysis: We used standard methodological procedures expected by Cochrane. We carried out subgroup analyses where possible to investigate the impact of factors such as gender, age, setting (general practice versus emergency care), treatment exposure and baseline consumption. Main results: We included 69 studies that randomised a total of 33,642 participants. Of these, 42 studies were added for this update (24,057 participants). Most interventions were delivered in general practice (38 studies, 55%) or emergency care (27 studies, 39%) settings. Most studies (61 studies, 88%) compared brief intervention to minimal or no intervention. Extended interventions were compared with brief (4 studies, 6%), minimal or no intervention (7 studies, 10%). Few studies targeted particular age groups: adolescents or young adults (6 studies, 9%) and older adults (4 studies, 6%). Mean baseline alcohol consumption was 244 g/week (30.5 standard UK units) among the studies that reported these data. Main sources of bias were attrition and lack of provider or participant blinding. The primary meta-analysis included 34 studies (15,197 participants) and provided moderate-quality evidence that participants who received brief intervention consumed less alcohol than minimal or no intervention participants after one year (mean difference (MD) -20 g/week, 95% confidence interval (CI) -28 to -12). There was substantial heterogeneity among studies (I² = 73%). A subgroup analysis by gender demonstrated that both men and women reduced alcohol consumption after receiving a brief intervention. We found moderate-quality evidence that brief alcohol interventions have little impact on frequency of binges per week (MD -0.08, 95% CI -0.14 to -0.02; 15 studies, 6946 participants); drinking days per week (MD -0.13, 95% CI -0.23 to -0.04; 11 studies, 5469 participants); or drinking intensity (-0.2 g/drinking day, 95% CI -3.1 to 2.7; 10 studies, 3128 participants).We found moderate-quality evidence of little difference in quantity of alcohol consumed when extended and no or minimal interventions were compared (-14 g/week, 95% CI -37 to 9; 6 studies, 1296 participants). There was little difference in binges per week (-0.08, 95% CI -0.28 to 0.12; 2 studies, 456 participants; moderate-quality evidence) or difference in days drinking per week (-0.45, 95% CI -0.81 to -0.09; 2 studies, 319 participants; moderate-quality evidence). Extended versus no or minimal intervention provided little impact on drinking intensity (9 g/drinking day, 95% CI -26 to 9; 1 study, 158 participants; low-quality evidence).Extended intervention had no greater impact than brief intervention on alcohol consumption, although findings were imprecise (MD 2 g/week, 95% CI -42 to 45; 3 studies, 552 participants; low-quality evidence). Numbers of binges were not reported for this comparison, but one trial suggested a possible drop in days drinking per week (-0.5, 95% CI -1.2 to 0.2; 147 participants; low-quality evidence). Results from this trial also suggested very little impact on drinking intensity (-1.7 g/drinking day, 95% CI -18.9 to 15.5; 147 participants; very low-quality evidence).Only five studies reported adverse effects (very low-quality evidence). No participants experienced any adverse effects in two studies; one study reported that the intervention increased binge drinking for women and two studies reported adverse events related to driving outcomes but concluded they were equivalent in both study arms. Sources of funding were reported by 67 studies (87%). With two exceptions, studies were funded by government institutes, research bodies or charitable foundations. One study was partly funded by a pharmaceutical company and a brewers association, another by a company developing diagnostic testing equipment. Authors' conclusions: We found moderate-quality evidence that brief interventions can reduce alcohol consumption in hazardous and harmful drinkers compared to minimal or no intervention. Longer counselling duration probably has little additional effect. Future studies should focus on identifying the components of interventions which are most closely associated with effectiveness.

The Cochrane database of systematic reviews · meta-analysis · 409 citationsread the source →

Interventions for the treatment of metastatic extradural spinal cord compression in adults.

Background: Metastatic extradural spinal cord compression (MESCC) is treated with radiotherapy, corticosteroids, and surgery, but there is uncertainty regarding their comparative effects. This is an updated version of the original Cochrane review published in theCochrane Database of Systematic Reviews (Issue 4, 2008). Objectives: To determine the efficacy and safety of radiotherapy, surgery and corticosteroids in MESCC. Search methods: In March 2015, we updated previous searches (July 2008 and December 2013) of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, LILACS, CANCERLIT, clinical trials registries, conference proceedings, and references, without language restrictions. We also contacted experts for relevant published, unpublished and ongoing trials. Selection criteria: Randomised controlled trials (RCTs) of radiotherapy, surgery and corticosteroids in adults with MESCC. Data collection and analysis: Three authors independently screened and selected trials, assessed risk of bias, and extracted data. We sought clarifications from trial authors. Where possible, we pooled relative risks with their 95% confidence intervals, using a random effects model if heterogeneity was significant. We assessed overall evidence-quality using the GRADE approach. Main results: This update includes seven trials involving 876 (723 evaluable) adult participants (19 to 87 years) in high-income countries. Most were free of the risk of bias. Different radiotherapy doses and schedulesTwo equivalence trials in people with MESCC and a poor prognosis evaluated different radiotherapy doses and schedules. In one, a single dose (8 Gray (Gy)) of radiotherapy (RT) was as effective as short-course RT (16 Gy in two fractions over one week) in enhancing ambulation in the short term (65% versus 69%; risk ratio (RR) was 0.93, (95% confidence interval (CI) 0.82 to 1.04); 303 participants; moderate quality evidence). The regimens were also equally effective in reducing analgesic and narcotic use (34% versus 40%; RR 0.85, 95% CI 0.62 to 1.16; 271 participants), and in maintaining urinary continence (90% versus 87%; RR 1.03, 95% CI 0.96 to 1.1; 303 participants) in the short term (moderate quality evidence). In the other trial, split-course RT (30 Gy in eight fractions over two weeks) was no different from short-course RT in enhancing ambulation (70% versus 68%; RR 1.02, 95% CI 0.9 to 1.15; 276 participants); reducing analgesic and narcotic use (49% versus 38%; RR 1.27, 95% CI 0.96 to 1.67; 262 participants); and in maintaining urinary continence (87% versus 90%; RR 0.97, 0.93 to 1.02; 275 participants) in the short term (moderate quality evidence). Median survival was similar with the three RT regimens (four months). Local tumour recurrence may be more common with single-dose compared to short-course RT (6% versus 3%; RR 2.21, 95% CI 0.69 to 7.01; 303 participants) and with short-course compared to split-course RT (4% versus 0%; RR 0.1, 95% CI 0.01 to 1.72; 276 participants), but these differences were not statistically significant (low quality evidence). Gastrointestinal adverse effects were infrequent with the three RT regimens (moderate quality evidence), and serious adverse events or post-radiotherapy myelopathy were not noted. We did not find trials comparing radiotherapy schedules in people with MESCC and a good prognosis. Surgery plus radiotherapy compared to radiotherapyLaminectomy plus RT offered no advantage over RT in one small trial with 29 participants (very low quality evidence). In another trial that was stopped early for apparent benefit, decompressive surgery plus RT resulted in better ambulatory rates (84% versus 57%; RR 1.48, 95% CI 1.16 to 1.90; 101 participants, low quality evidence). Narcotic use may also be lower, and bladder control may also be maintained longer than with than RT in selected patients (low quality evidence). Median survival was longer after surgery (126 days versus 100 days), but the proportions surviving at one month (94% versus 86%; RR 1.09, 95% CI 0.96 to 1.24; 101 participants) did not differ significantly (low quality evidence). Serious adverse events were not noted. Significant benefits with surgery occurred only in people younger than 65 years. High dose corticosteroids compared to moderate dose or no corticosteroidsData from three small trials suggest that high-dose steroids may not differ from moderate-dose or no corticosteroids in enhancing ambulation (60% versus 55%; RR 1.08, 95% CI 0.81 to 1.45; 3 RCTs, 105 participants); survival over two years (11% versus 10%; RR 1.11, 95% CI 0.24 to 5.05; 1 RCT, 57 participants); pain reduction (78% versus 91%; RR 0.86, 95% CI 0.62 to 1.20; 1 RCT, 25 participants); or urinary continence (63% versus 53%; RR 1.18, 95% CI 0.66 to 2.13; 1 RCT, 34 participants; low quality evidence). Serious adverse effects were more frequent with high-dose corticosteroids (17% versus 0%; RR 8.02, 95% CI 1.03 to 62.37; 2 RCTs, 77 participants; moderate quality evidence).None of the trials reported satisfaction with care or quality of life in participants. Authors' conclusions: Based on current evidence, ambulant adults with MESCC with stable spines and predicted survival of less than six months will probably benefit as much from one dose of radiation (8 Gy) as from two doses (16 Gy) or eight doses (30 Gy). We are unsure if a single dose is as effective as two or more doses in preventing local tumour recurrence. Laminectomy preceding radiotherapy may offer no benefits over radiotherapy alone. Decompressive surgery followed by radiotherapy may benefit ambulant and non-ambulant adults younger than 65 years of age, with poor prognostic factors for radiotherapy, a single area of compression, paraplegia for less than 48 hours, and a predicted survival of more than six months. We are uncertain whether high doses of corticosteroids offer any benefits over moderate doses or indeed no corticosteroids; but high-dose steroids probably significantly increases the risk of serious adverse effects. Early detection; and treatment based on neurological status, age and estimated survival, are crucial with all treatment modalities. Most of the evidence was of low quality. High-quality evidence from more trials is needed to clarify current uncertainties, and some studies are in progress.

The Cochrane database of systematic reviews · meta-analysis · 39 citationsread the source →

A randomized controlled comparison of guided self-help cognitive behavioral therapy and behavioral weight loss for binge eating disorder.

We performed a randomized controlled study to test the relative efficacy of guided self-help (gsh) cognitive-behavioral therapy (CBTgsh) and behavioral weight loss treatment (BWLgsh) treatments for binge eating disorder (BED). To provide an additional partial control for non-specific influences of attention, a third control (CON) treatment condition was included. We tested the treatments using a guided self-help approach given the promising results from initial studies using minimal therapist guidance. Ninety consecutive overweight patients (19 males, 71 females) with BED were randomly assigned (5:5:2 ratio) to one of three treatments: CBTgsh (N=37), BWLgsh (N=38), or CON (N=15). The three 12-week treatment conditions were administered individually following guided self-help protocols. Overall, 70 (78%) completed treatments; CBTgsh (87%) and CON (87%) had significantly higher completion rates than BWLgsh (67%). Intent-to-treat analyses revealed that CBTgsh had significantly higher remission rates (46%) than either BWLgsh (18%) or CON (13%). Weight loss was minimal and differed little across treatments. The findings suggest that CBT, administered via guided self-help, demonstrates efficacy for BED, but not for obesity. The findings support CBT administered via guided self-help as a first step in the treatment of BED and provide evidence for its specific effects.

Behaviour research and therapy · randomised controlled trial · 124 citationsread the source →

The effectiveness of manual-guided, problem-solving-based self-learning programme for family caregivers of people with recent-onset psychosis: A randomised controlled trial with 6-month follow-up.

Background: Family intervention for psychotic disorders is an integral part of psychiatric treatment with positive effects on patients' mental state and relapse rate. However, the effect of such family-based intervention on caregivers' psychological distress and well-being, especially in non-Western countries, has received comparatively much less attention. Objectives: To test the effects of guided problem-solving-based manual-guided self-learning programme for family caregivers of adults with recent-onset psychosis over a 6-month period of follow-up, when compared with those in usual family support service. Design: A single-centre randomised controlled trial, which was registered at ClinicalTrials.gov (NCT02391649), with a repeated-measures, two-arm (parallel-group) design. Settings: One main psychiatric outpatient clinic in the New Territories of Hong Kong. Participants: A random sample of 116 family caregiverss of adult outpatients with recent-onset psychosis. Methods: Following pre-test measurement, caregivers were assigned randomly to one of two study groups: a 5-month self-help, problem-solving-based manual-guided self-learning (or bibliotherapy) programme (in addition to usual care), or usual family support service only. Varieties of patient and caregiver health outcomes were assessed and compared at baseline and at 1-week and 6-month post-intervention. Results: One hundred and eleven (96%) caregivers completed the 6-month follow-up (two post-tests); 55 of them (95%) completed ≥4 modules and attended ≥2 review sessions (i.e., 75% of the intervention). The family participants' mean age was about 38 years and over 64% of them were female and patient's parent or spouse. Multivariate analyses of variance indicated that the manual-guided self-learning group reported significantly greater improvements than the usual care group in family burden [F(1,110)=6.21, p=0.006] and caregiving experience [F(1,110)=6.88, p=0.0004], and patients' psychotic symptoms [F(1,110)=6.25, p=0.0003], functioning [F(1,110)=7.01, p=0.0005] and number of hospitalisations [F(1,110)=5.71, p=0.005] over 6-month follow-up. Conclusions: Problem-solving-based, manual-guided self-learning programme for family caregivers of adults with recent-onset psychosis can be an effective self-help programme and provide medium-term benefits to patients' and caregivers' mental health and duration of patients' re-hospitalisations.

International journal of nursing studies · randomised controlled trial · 21 citationsread the source →

Arrhythmogenic right ventricular dysplasia: a United States experience.

Background: Arrhythmogenic right ventricular dysplasia (ARVD) is an inherited cardiomyopathy characterized by right ventricular dysfunction and ventricular arrhythmias. The purpose of our study was to describe the presentation, clinical features, survival, and natural history of ARVD in a large cohort of patients from the United States. Methods and results: The patient population included 100 ARVD patients (51 male; median age at presentation, 26 [interquartile range {IQR}, 18 to 38; range, 2 to 70] years). A familial pattern was observed in 32 patients. The most common presenting symptoms were palpitations, syncope, and sudden cardiac death (SCD) in 27%, 26%, and 23% of patients, respectively. Among those who were diagnosed while living (n=69), the median time between first presentation and diagnosis was 1 (range, 0 to 37) year. During a median follow-up of 6 (IQR, 2 to 13; range, 0 to 37) years, implantable cardioverter/defibrillators (ICD) were implanted in 47 patients, 29 of whom received an appropriate ICD discharge, including 3 patients who received the ICD for primary prevention. At follow-up, 66 patients were alive, of whom 44 had an ICD in place, 5 developed signs of heart failure, 2 had a heart transplant, and 18 were on drug therapy. Thirty-four patients died either at presentation (n=23: 21 SCD, 2 noncardiac deaths) or during follow-up (n=11: 10 SCD, 1 of biventricular heart failure), of whom only 3 were diagnosed while living and 1 had an ICD implanted. On Kaplan-Meier analysis, the median survival in the entire population was 60 years. Conclusions: ARVD patients present between the second and fifth decades of life either with symptoms of palpitations and syncope associated with ventricular tachycardia or with SCD. Diagnosis is often delayed. Once diagnosed and treated with an ICD, mortality is low. There is a wide variation in presentation and course of ARVD patients, which can likely be explained by the genetic heterogeneity of the disease.

Circulation · 328 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 →

Systematic review of systematic reviews of non-pharmacological interventions to treat behavioural disturbances in older patients with dementia. The SENATOR-OnTop series.

Objective: To provide an overview of non-pharmacological interventions for behavioural and psychological symptoms in dementia (BPSD). Design: Systematic overview of reviews. Data sources: PubMed, EMBASE, Cochrane Database of Systematic Reviews, CINAHL and PsycINFO (2009-March 2015). Eligibility criteria: Systematic reviews (SRs) that included at least one comparative study evaluating any non-pharmacological intervention, to treat BPSD. Data extraction: Eligible studies were selected and data extracted independently by 2 reviewers. The AMSTAR checklist was used to assess the quality of the SRs. Data analysis: Extracted data were synthesised using a narrative approach. Results: 38 SRs and 129 primary studies were identified, comprising the following categories of non-pharmacological interventions: (1) sensory stimulation interventions (25 SRs, 66 primary studies) that encompassed: shiatsu and acupressure, aromatherapy, massage/touch therapy, light therapy, sensory garden and horticultural activities, music/dance therapy, dance therapy, snoezelen multisensory stimulation therapy, transcutaneous electrical nerve stimulation; (2) cognitive/emotion-oriented interventions (13 SRs; 26 primary studies) that included cognitive stimulation, reminiscence therapy, validation therapy, simulated presence therapy; (3) behaviour management techniques (6 SRs; 22 primary studies); (4) Multicomponent interventions (3 SR; four primary studies); (5) other therapies (5 SRs, 15 primary studies) comprising exercise therapy, animal-assisted therapy, special care unit and dining room environment-based interventions. Conclusions: A large number of non-pharmacological interventions for BPSD were identified. The majority of the studies had great variation in how the same type of intervention was defined and applied, the follow-up duration, the type of outcome measured, usually with modest sample size. Overall, music therapy and behavioural management techniques were effective for reducing BPSD.

BMJ open · systematic review · 261 citationsread the source →

Social Media Use and Health and Well-being of Lesbian, Gay, Bisexual, Transgender, and Queer Youth: Systematic Review.

Background: Lesbian, gay, bisexual, transgender, and queer (LGBTQ) individuals are at higher risk of poor mental health and well-being. Social media platforms can provide LGBTQ youths with a space that counters heteronormative environments and potentially supports mental health and well-being. Mental health includes an individual's state of psychological and emotional well-being and not merely the absence of mental disorders. Objective: We sought to identify how LGBTQ youths and adolescents use social media for connection with other LGBTQ peers and groups, identity development, and social support and how these affect mental health and well-being. Methods: PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) procedures were used to guide this review. Searches were conducted in ACM Digital Library, CINAHL, Ovid Embase, Ovid MEDLINE, and Web of Science in March 2021. This review focused on LGBTQ youths aged 10 to 24 years. Included peer-reviewed studies must comprise social media; explore peer connection, identity development, or social support; and be published from 2012 onward. In total, 2 researchers extracted data and performed quality assessments independently using the Newcastle-Ottawa Scale for quantitative articles and the Critical Appraisal Skills Programme for qualitative articles. Qualitative synthesis was performed on articles that satisfied the eligibility criteria. Results: A total of 26 studies (n=15, 58% qualitative; n=8, 31% quantitative; n=3, 12% mixed methods) met the inclusion criteria. Of the 8 quantitative studies, 6 (75%) were cross-sectional, and 2 (25%) were cohort studies. All studies ranged from moderate to high quality. Social media was a popular tool used by LGBTQ youths to connect with LGBTQ communities. In qualitative data, we found that LGBTQ youths negotiated and explored identity and obtained support from peers on social media. Instagram, Tumblr, and Twitter were commonly used to access LGBTQ content owing to ease of anonymity. Identity management was the most studied social media affordance, important to LGBTQ youths for strategic disclosure. Key strategies for managing identities included being anonymous, censoring locations or content, restricting audiences, and using multiple accounts. Quantitative studies (3/8, 38%) showed that social media was associated with reduced mental health concerns and increased well-being among LGBTQ youths. Mental health concerns arising from social media use were attributed to discrimination, victimization, and policies that did not accommodate changed identities. Conclusions: We found that social media may support the mental health and well-being of LGBTQ youths through peer connection, identity management, and social support, but findings were limited by weaknesses in the evidence. More robust and longitudinal studies are needed to determine the relationship between social media use and LGBTQ mental health, particularly among adolescents. The findings may inform interventions to promote social media health literacy and the mental health and well-being of this vulnerable group. Trial registration: PROSPERO CRD42020222535; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=222535.

Journal of medical Internet research · systematic review · 84 citationsread the source →

Exercise as adjunctive therapy for systemic lupus erythematosus.

Background: Systemic lupus erythematosus (SLE) is a rare, chronic autoimmune inflammatory disease with a prevalence varying from 4.3 to 150 people in 100,000, or approximately five million people worldwide. Systemic manifestations frequently include internal organ involvement, a characteristic malar rash on the face, pain in joints and muscles, and profound fatigue. Exercise is purported to be beneficial for people with SLE. For this review, we focused on studies that examined all types of structured exercise as an adjunctive therapy in the management of SLE. Objectives: To evaluate the benefits and harms of structured exercise as adjunctive therapy for adults with SLE compared with usual pharmacological care, usual pharmacological care plus placebo and usual pharmacological care plus non-pharmacological care. Search methods: We used standard, extensive Cochrane search methods. The latest search date was 30 March 2022. Selection criteria: We included randomised controlled trials (RCTs) of exercise as an adjunct to usual pharmacological treatment in SLE compared with placebo, usual pharmacological care alone and another non-pharmacological treatment. Major outcomes were fatigue, functional capacity, disease activity, quality of life, pain, serious adverse events, and withdrawals due to any reason, including any adverse events. Data collection and analysis: We used standard Cochrane methods. Our major outcomes were 1. fatigue, 2. functional capacity, 3. disease activity, 4. quality of life, 5. pain, 6. serious adverse events, and 7. withdrawals due to any reason. Our minor outcomes were 8. responder rate, 9. aerobic fitness, 10. depression, and 11. anxiety. We used GRADE to assess certainty of evidence. The primary comparison was exercise compared with placebo. Main results: We included 13 studies (540 participants) in this review. Studies compared exercise as an adjunct to usual pharmacological care (antimalarials, immunosuppressants, and oral glucocorticoids) with usual pharmacological care plus placebo (one study); usual pharmacological care (six studies); and another non-pharmacological treatment such as relaxation therapy (seven studies). Most studies had selection bias, and all studies had performance and detection bias. We downgraded the evidence for all comparisons because of a high risk of bias and imprecision. Exercise plus usual pharmacological care versus placebo plus usual pharmacological care Evidence from a single small study (17 participants) that compared whole body vibration exercise to whole body placebo vibration exercise (vibrations switched off) indicated that exercise may have little to no effect on fatigue, functional capacity, and pain (low-certainty evidence). We are uncertain whether exercise results in fewer or more withdrawals (very low-certainty evidence). The study did not report disease activity, quality of life, and serious adverse events. The study measured fatigue using the self-reported Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue), scale 0 to 52; lower score means less fatigue. People who did not exercise rated their fatigue at 38 points and those who did exercise rated their fatigue at 33 points (mean difference (MD) 5 points lower, 95% confidence interval (CI) 13.29 lower to 3.29 higher). The study measured functional capacity using the self-reported 36-item Short Form health questionnaire (SF-36) Physical Function domain, scale 0 to 100; higher score means better function. People who did not exercise rated their functional capacity at 70 points and those who did exercise rated their functional capacity at 67.5 points (MD 2.5 points lower, 95% CI 23.78 lower to 18.78 higher). The study measured pain using the SF-36 Pain domain, scale 0 to 100; lower scores mean less pain. People who did not exercise rated their pain at 43 points and those who did exercise rated their pain at 34 points (MD 9 points lower, 95% CI 28.88 lower to 10.88 higher). More participants from the exercise group (3/11, 27%) withdrew from the study than the placebo group (1/10, 10%) (risk ratio (RR) 2.73, 95% CI 0.34 to 22.16). Exercise plus usual pharmacological care versus usual pharmacological care alone The addition of exercise to usual pharmacological care may have little to no effect on fatigue, functional capacity, and disease activity (low-certainty evidence). We are uncertain whether the addition of exercise improves pain (very low-certainty evidence), or results in fewer or more withdrawals (very low-certainty evidence). Serious adverse events and quality of life were not reported. Exercise plus usual care versus another non-pharmacological intervention such as receiving information about the disease or relaxation therapy Compared with education or relaxation therapy, exercise may reduce fatigue slightly (low-certainty evidence), may improve functional capacity (low-certainty evidence), probably results in little to no difference in disease activity (moderate-certainty evidence), and may result in little to no difference in pain (low-certainty evidence). We are uncertain whether exercise results in fewer or more withdrawals (very low-certainty evidence). Quality of life and serious adverse events were not reported. Authors' conclusions: Due to low- to very low-certainty evidence, we are not confident on the benefits of exercise on fatigue, functional capacity, disease activity, and pain, compared with placebo, usual care, or advice and relaxation therapy. Harms data were not well reported.

The Cochrane database of systematic reviews · systematic review · 11 citationsread the source →

Electronic cigarettes for smoking cessation.

Background: Electronic cigarettes (ECs) are handheld electronic vaping devices which produce an aerosol by heating an e-liquid. Some people who smoke use ECs to stop or reduce smoking, although some organizations, advocacy groups and policymakers have discouraged this, citing lack of evidence of efficacy and safety. People who smoke, healthcare providers and regulators want to know if ECs can help people quit smoking, and if they are safe to use for this purpose. This is a review update conducted as part of a living systematic review. Objectives: To examine the effectiveness, tolerability, and safety of using electronic cigarettes (ECs) to help people who smoke tobacco achieve long-term smoking abstinence. Search methods: We searched the Cochrane Tobacco Addiction Group's Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO to 1 July 2022, and reference-checked and contacted study authors.  SELECTION CRITERIA: We included randomized controlled trials (RCTs) and randomized cross-over trials, in which people who smoke were randomized to an EC or control condition. We also included uncontrolled intervention studies in which all participants received an EC intervention. Studies had to report abstinence from cigarettes at six months or longer or data on safety markers at one week or longer, or both. Data collection and analysis: We followed standard Cochrane methods for screening and data extraction. Our primary outcome measures were abstinence from smoking after at least six months follow-up, adverse events (AEs), and serious adverse events (SAEs). Secondary outcomes included the proportion of people still using study product (EC or pharmacotherapy) at six or more months after randomization or starting EC use, changes in carbon monoxide (CO), blood pressure (BP), heart rate, arterial oxygen saturation, lung function, and levels of carcinogens or toxicants, or both. We used a fixed-effect Mantel-Haenszel model to calculate risk ratios (RRs) with a 95% confidence interval (CI) for dichotomous outcomes. For continuous outcomes, we calculated mean differences. Where appropriate, we pooled data in meta-analyses. Main results: We included 78 completed studies, representing 22,052 participants, of which 40 were RCTs. Seventeen of the 78 included studies were new to this review update. Of the included studies, we rated ten (all but one contributing to our main comparisons) at low risk of bias overall, 50 at high risk overall (including all non-randomized studies), and the remainder at unclear risk. There was high certainty that quit rates were higher in people randomized to nicotine EC than in those randomized to nicotine replacement therapy (NRT) (RR 1.63, 95% CI 1.30 to 2.04; I2 = 10%; 6 studies, 2378 participants). In absolute terms, this might translate to an additional four quitters per 100 (95% CI 2 to 6). There was moderate-certainty evidence (limited by imprecision) that the rate of occurrence of AEs was similar between groups (RR 1.02, 95% CI 0.88 to 1.19; I2 = 0%; 4 studies, 1702 participants). SAEs were rare, but there was insufficient evidence to determine whether rates differed between groups due to very serious imprecision (RR 1.12, 95% CI 0.82 to 1.52; I2 = 34%; 5 studies, 2411 participants). There was moderate-certainty evidence, limited by imprecision, that quit rates were higher in people randomized to nicotine EC than to non-nicotine EC (RR 1.94, 95% CI 1.21 to 3.13; I2 = 0%; 5 studies, 1447 participants). In absolute terms, this might lead to an additional seven quitters per 100 (95% CI 2 to 16). There was moderate-certainty evidence of no difference in the rate of AEs between these groups (RR 1.01, 95% CI 0.91 to 1.11; I2 = 0%; 5 studies, 1840 participants). There was insufficient evidence to determine whether rates of SAEs differed between groups, due to very serious imprecision (RR 1.00, 95% CI 0.56 to 1.79; I2 = 0%; 8 studies, 1272 participants). Compared to behavioural support only/no support, quit rates were higher for participants randomized to nicotine EC (RR 2.66, 95% CI 1.52 to 4.65; I2 = 0%; 7 studies, 3126 participants). In absolute terms, this represents an additional two quitters per 100 (95% CI 1 to 3). However, this finding was of very low certainty, due to issues with imprecision and risk of bias. There was some evidence that (non-serious) AEs were more common in people randomized to nicotine EC (RR 1.22, 95% CI 1.12 to 1.32; I2 = 41%, low certainty; 4 studies, 765 participants) and, again, insufficient evidence to determine whether rates of SAEs differed between groups (RR 1.03, 95% CI 0.54 to 1.97; I2 = 38%; 9 studies, 1993 participants).  Data from non-randomized studies were consistent with RCT data. The most commonly reported AEs were throat/mouth irritation, headache, cough, and nausea, which tended to dissipate with continued EC use. Very few studies reported data on other outcomes or comparisons, hence evidence for these is limited, with CIs often encompassing clinically significant harm and benefit. Authors' conclusions: There is high-certainty evidence that ECs with nicotine increase quit rates compared to NRT and moderate-certainty evidence that they increase quit rates compared to ECs without nicotine. Evidence comparing nicotine EC with usual care/no treatment also suggests benefit, but is less certain. More studies are needed to confirm the effect size. Confidence intervals were for the most part wide for data on AEs, SAEs and other safety markers, with no difference in AEs between nicotine and non-nicotine ECs nor between nicotine ECs and NRT. Overall incidence of SAEs was low across all study arms. We did not detect evidence of serious harm from nicotine EC, but longest follow-up was two years and the number of studies was small. The main limitation of the evidence base remains imprecision due to the small number of RCTs, often with low event rates, but further RCTs are underway. To ensure the review continues to provide up-to-date information to decision-makers, this review is a living systematic review. We run searches monthly, with the review updated when relevant new evidence becomes available. Please refer to the Cochrane Database of Systematic Reviews for the review's current status.

The Cochrane database of systematic reviews · systematic review · 147 citationsread the source →

Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation.

Background: Nicotine replacement therapy (NRT) aims to replace nicotine from cigarettes to ease the transition from cigarette smoking to abstinence. It works by reducing the intensity of craving and withdrawal symptoms. Although there is clear evidence that NRT used after smoking cessation is effective, it is unclear whether higher doses, longer durations of treatment, or using NRT before cessation add to its effectiveness. Objectives: To determine the effectiveness and safety of different forms, deliveries, doses, durations and schedules of NRT, for achieving long-term smoking cessation, compared to one another. Search methods: We searched the Cochrane Tobacco Addiction Group trials register, and trial registries for papers mentioning NRT in the title, abstract or keywords. Date of most recent search: April 2018. Selection criteria: Randomized trials in people motivated to quit, comparing one type of NRT use with another. We excluded trials that did not assess cessation as an outcome, with follow-up less than six months, and with additional intervention components not matched between arms. Trials comparing NRT to control, and trials comparing NRT to other pharmacotherapies, are covered elsewhere. Data collection and analysis: We followed standard Cochrane methods. Smoking abstinence was measured after at least six months, using the most rigorous definition available. We extracted data on cardiac adverse events (AEs), serious adverse events (SAEs), and study withdrawals due to treatment. We calculated the risk ratio (RR) and the 95% confidence interval (CI) for each outcome for each study, where possible. We grouped eligible studies according to the type of comparison. We carried out meta-analyses where appropriate, using a Mantel-Haenszel fixed-effect model. Main results: We identified 63 trials with 41,509 participants. Most recruited adults either from the community or from healthcare clinics. People enrolled in the studies typically smoked at least 15 cigarettes a day. We judged 24 of the 63 studies to be at high risk of bias, but restricting the analysis only to those studies at low or unclear risk of bias did not significantly alter results, apart from in the case of the preloading comparison. There is high-certainty evidence that combination NRT (fast-acting form + patch) results in higher long-term quit rates than single form (RR 1.25, 95% CI 1.15 to 1.36, 14 studies, 11,356 participants; I2 = 4%). Moderate-certainty evidence, limited by imprecision, indicates that 42/44 mg are as effective as 21/22 mg (24-hour) patches (RR 1.09, 95% CI 0.93 to 1.29, 5 studies, 1655 participants; I2 = 38%), and that 21 mg are more effective than 14 mg (24-hour) patches (RR 1.48, 95% CI 1.06 to 2.08, 1 study, 537 participants). Moderate-certainty evidence (again limited by imprecision) also suggests a benefit of 25 mg over 15 mg (16-hour) patches, but the lower limit of the CI encompassed no difference (RR 1.19, 95% CI 1.00 to 1.41, 3 studies, 3446 participants; I2 = 0%). Five studies comparing 4 mg gum to 2 mg gum found a benefit of the higher dose (RR 1.43, 95% CI 1.12 to 1.83, 5 studies, 856 participants; I2 = 63%); however, results of a subgroup analysis suggest that only smokers who are highly dependent may benefit. Nine studies tested the effect of using NRT prior to quit day (preloading) in comparison to using it from quit day onward; there was moderate-certainty evidence, limited by risk of bias, of a favourable effect of preloading on abstinence (RR 1.25, 95% CI 1.08 to 1.44, 9 studies, 4395 participants; I2 = 0%). High-certainty evidence from eight studies suggests that using either a form of fast-acting NRT or a nicotine patch results in similar long-term quit rates (RR 0.90, 95% CI 0.77 to 1.05, 8 studies, 3319 participants; I2 = 0%). We found no evidence of an effect of duration of nicotine patch use (low-certainty evidence); 16-hour versus 24-hour daily patch use; duration of combination NRT use (low- and very low-certainty evidence); tapering of patch dose versus abrupt patch cessation; fast-acting NRT type (very low-certainty evidence); duration of nicotine gum use; ad lib versus fixed dosing of fast-acting NRT; free versus purchased NRT; length of provision of free NRT; ceasing versus continuing patch use on lapse; and participant- versus clinician-selected NRT. However, in most cases these findings are based on very low- or low-certainty evidence, and are the findings from single studies.AEs, SAEs and withdrawals due to treatment were all measured variably and infrequently across studies, resulting in low- or very low-certainty evidence for all comparisons. Most comparisons found no evidence of an effect on cardiac AEs, SAEs or withdrawals. Rates of these were low overall. Significantly more withdrawals due to treatment were reported in participants using nasal spray in comparison to patch in one trial (RR 3.47, 95% CI 1.15 to 10.46, 922 participants; very low certainty) and in participants using 42/44 mg patches in comparison to 21/22 mg patches across two trials (RR 4.99, 95% CI 1.60 to 15.50, 2 studies, 544 participants; I2 = 0%; low certainty). Authors' conclusions: There is high-certainty evidence that using combination NRT versus single-form NRT, and 4 mg versus 2 mg nicotine gum, can increase the chances of successfully stopping smoking. For patch dose comparisons, evidence was of moderate certainty, due to imprecision. Twenty-one mg patches resulted in higher quit rates than 14 mg (24-hour) patches, and using 25 mg patches resulted in higher quit rates than using 15 mg (16-hour) patches, although in the latter case the CI included one. There was no clear evidence of superiority for 42/44 mg over 21/22 mg (24-hour) patches. Using a fast-acting form of NRT, such as gum or lozenge, resulted in similar quit rates to nicotine patches. There is moderate-certainty evidence that using NRT prior to quitting may improve quit rates versus using it from quit date only; however, further research is needed to ensure the robustness of this finding. Evidence for the comparative safety and tolerability of different types of NRT use is of low and very low certainty. New studies should ensure that AEs, SAEs and withdrawals due to treatment are both measured and reported.

The Cochrane database of systematic reviews · systematic review · 126 citationsread the source →

Personal and work-related factors associated with nurse resilience: A systematic review.

Background: Nursing shortages have profoundly impacted hospitals and consequently increased financial expenditure, resulting in work overload, thus augmenting nurses' stress and burnout levels. Studies have found that resilience helps nurses reduce the effects of stress and burnout. However, the factors associated with nurse resilience are yet to be determined. Objectives: This systematic review aims to identify the associated personal and work-related factors of nurse resilience. Design: This systematic review has been registered in the international prospective register of systematic reviews (Registered Number: CRD 42018094080). Results are reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses protocol. Data sources: The systematic search was undertaken between March and April 2018 in five databases: CINAHL Plus, MEDLINE (Ovid), PsycINFO, EMBASE, and Scopus. The searched terms combined in each database were: resilience, hardiness, work, employ, occupation, job, and nursing. Review methods: Full-text English articles published between 2000 and 2018 were included. Studies were also included if they involved: (1) nurses who provided direct patient care, (2) resilience and its associated factors, (3) an empirical quantitative study, and (4) a quality assessment grade of 'good' or 'fair'. Two authors carried out the study eligibility and quality assessment independently. A narrative synthesis was utilised following the Job Demands-Resources model to identify the factors of job demands and resources, which were associated with nurse resilience. Results: A total of 38 articles met the criteria and were systematically reviewed and narratively synthesised. Various resilience scales utilised in these studies made it unfeasible to synthesise the evidence using a meta-analysis. Inconsistencies exist when examining personal and work-related factors. Job demands (stress, burnout, posttraumatic stress disorder, and workplace bullying) were negatively associated with resilience, while job resources (coping skills, self-efficacy, social support, job satisfaction, job retention, and general wellbeing) were positively related to resilience. Using a quality assessment tool, 23 studies were rated as 'Good', 15 were assessed as 'Fair', and 20 were found to have a risk of bias. Conclusions: Understanding nurse resilience can proactively help nurses identify or prevent potential problems, thus fostering job resources and ultimately achieving personal and professional growth. Increased nurse resilience can help nurses reduce emotional exhaustion, increase work engagement, and enhance function when facing workplace challenges. This can assist nurses to establish strategies to deal with adversity and attenuate the effects of job demands. Further research is needed to explore nurse resilience and develop a consistent instrument for measuring resilience.

International journal of nursing studies · systematic review · 267 citationsread the source →

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

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

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

Behavioural interventions for smoking cessation: an overview and network meta-analysis.

Background: Smoking is a leading cause of disease and death worldwide. In people who smoke, quitting smoking can reverse much of the damage. Many people use behavioural interventions to help them quit smoking; these interventions can vary substantially in their content and effectiveness. Objectives: To summarise the evidence from Cochrane Reviews that assessed the effect of behavioural interventions designed to support smoking cessation attempts and to conduct a network meta-analysis to determine how modes of delivery; person delivering the intervention; and the nature, focus, and intensity of behavioural interventions for smoking cessation influence the likelihood of achieving abstinence six months after attempting to stop smoking; and whether the effects of behavioural interventions depend upon other characteristics, including population, setting, and the provision of pharmacotherapy. To summarise the availability and principal findings of economic evaluations of behavioural interventions for smoking cessation, in terms of comparative costs and cost-effectiveness, in the form of a brief economic commentary. Methods: This work comprises two main elements. 1. We conducted a Cochrane Overview of reviews following standard Cochrane methods. We identified Cochrane Reviews of behavioural interventions (including all non-pharmacological interventions, e.g. counselling, exercise, hypnotherapy, self-help materials) for smoking cessation by searching the Cochrane Library in July 2020. We evaluated the methodological quality of reviews using AMSTAR 2 and synthesised data from the reviews narratively. 2. We used the included reviews to identify randomised controlled trials of behavioural interventions for smoking cessation compared with other behavioural interventions or no intervention for smoking cessation. To be included, studies had to include adult smokers and measure smoking abstinence at six months or longer. Screening, data extraction, and risk of bias assessment followed standard Cochrane methods. We synthesised data using Bayesian component network meta-analysis (CNMA), examining the effects of 38 different components compared to minimal intervention. Components included behavioural and motivational elements, intervention providers, delivery modes, nature, focus, and intensity of the behavioural intervention. We used component network meta-regression (CNMR) to evaluate the influence of population characteristics, provision of pharmacotherapy, and intervention intensity on the component effects. We evaluated certainty of the evidence using GRADE domains. We assumed an additive effect for individual components. Main results: We included 33 Cochrane Reviews, from which 312 randomised controlled trials, representing 250,563 participants and 845 distinct study arms, met the criteria for inclusion in our component network meta-analysis. This represented 437 different combinations of components. Of the 33 reviews, confidence in review findings was high in four reviews and moderate in nine reviews, as measured by the AMSTAR 2 critical appraisal tool. The remaining 20 reviews were low or critically low due to one or more critical weaknesses, most commonly inadequate investigation or discussion (or both) of the impact of publication bias. Of note, the critical weaknesses identified did not affect the searching, screening, or data extraction elements of the review process, which have direct bearing on our CNMA. Of the included studies, 125/312 were at low risk of bias overall, 50 were at high risk of bias, and the remainder were at unclear risk. Analyses from the contributing reviews and from our CNMA showed behavioural interventions for smoking cessation can increase quit rates, but effectiveness varies on characteristics of the support provided. There was high-certainty evidence of benefit for the provision of counselling (odds ratio (OR) 1.44, 95% credibility interval (CrI) 1.22 to 1.70, 194 studies, n = 72,273) and guaranteed financial incentives (OR 1.46, 95% CrI 1.15 to 1.85, 19 studies, n = 8877). Evidence of benefit remained when removing studies at high risk of bias. These findings were consistent with pair-wise meta-analyses from contributing reviews. There was moderate-certainty evidence of benefit for interventions delivered via text message (downgraded due to unexplained statistical heterogeneity in pair-wise comparison), and for the following components where point estimates suggested benefit but CrIs incorporated no clinically significant difference: individual tailoring; intervention content including motivational components; intervention content focused on how to quit. The remaining intervention components had low-to very low-certainty evidence, with the main issues being imprecision and risk of bias. There was no evidence to suggest an increase in harms in groups receiving behavioural support for smoking cessation. Intervention effects were not changed by adjusting for population characteristics, but data were limited. Increasing intensity of behavioural support, as measured through the number of contacts, duration of each contact, and programme length, had point estimates associated with modestly increased chances of quitting, but CrIs included no difference. The effect of behavioural support for smoking cessation appeared slightly less pronounced when people were already receiving smoking cessation pharmacotherapies. Authors' conclusions: Behavioural support for smoking cessation can increase quit rates at six months or longer, with no evidence that support increases harms. This is the case whether or not smoking cessation pharmacotherapy is also provided, but the effect is slightly more pronounced in the absence of pharmacotherapy. Evidence of benefit is strongest for the provision of any form of counselling, and guaranteed financial incentives. Evidence suggested possible benefit but the need of further studies to evaluate: individual tailoring; delivery via text message, email, and audio recording; delivery by lay health advisor; and intervention content with motivational components and a focus on how to quit. We identified 23 economic evaluations; evidence did not consistently suggest one type of behavioural intervention for smoking cessation was more cost-effective than another. Future reviews should fully consider publication bias. Tools to investigate publication bias and to evaluate certainty in CNMA are needed.

The Cochrane database of systematic reviews · systematic review · 160 citationsread the source →

Strategies for enhancing the implementation of school-based policies or practices targeting diet, physical activity, obesity, tobacco or alcohol use.

Background: Several school-based interventions are effective in improving child diet and physical activity, and preventing excessive weight gain, and tobacco or harmful alcohol use. However, schools are frequently unsuccessful in implementing such evidence-based interventions. Objectives: 1. To evaluate the benefits and harms of strategies aiming to improve school implementation of interventions to address student diet, physical activity, tobacco or alcohol use, and obesity. 2. To evaluate the benefits and harms of strategies to improve intervention implementation on measures of student diet, physical activity, obesity, tobacco use or alcohol use; describe their cost or cost-effectiveness; and any harms of strategies on schools, school staff or students. Search methods: We used standard, extensive Cochrane search methods. The latest search was between 1 September 2016 and 30 April 2021 to identify any relevant trials published since the last published review. Selection criteria: We defined 'Implementation' as the use of strategies to adopt and integrate evidence-based health interventions and to change practice patterns within specific settings. We included any trial (randomised controlled trial (RCT) or non-randomised controlled trial (non-RCT)) conducted at any scale, with a parallel control group that compared a strategy to implement policies or practices to address diet, physical activity, overweight or obesity, tobacco or alcohol use by students to 'no intervention', 'usual' practice or a different implementation strategy. Data collection and analysis: We used standard Cochrane methods. Given the large number of outcomes reported, we selected and included the effects of a single outcome measure for each trial for the primary (implementation) and secondary (student health behaviour and obesity) outcomes using a decision hierarchy. Where possible, we calculated standardised mean differences (SMDs) to account for variable outcome measures with 95% confidence intervals (CI). For RCTs, we conducted meta-analyses of primary and secondary outcomes using a random-effects model, or in instances where there were between two and five studies, a fixed-effect model. The synthesis of the effects for non-randomised studies followed the 'Synthesis without meta-analysis' (SWiM) guidelines. Main results: We included an additional 11 trials in this update bringing the total number of included studies in the review to 38. Of these, 22 were conducted in the USA. Twenty-six studies used RCT designs. Seventeen trials tested strategies to implement healthy eating, 12 physical activity and six a combination of risk factors. Just one trial sought to increase the implementation of interventions to delay initiation or reduce the consumption of alcohol. All trials used multiple implementation strategies, the most common being educational materials, educational outreach and educational meetings. The overall certainty of evidence was low and ranged from very low to moderate for secondary review outcomes. Pooled analyses of RCTs found, relative to a control, the use of implementation strategies may result in a large increase in the implementation of interventions in schools (SMD 1.04, 95% CI 0.74 to 1.34; 22 RCTs, 1917 participants; low-certainty evidence). For secondary outcomes we found, relative to control, the use of implementation strategies to support intervention implementation may result in a slight improvement on measures of student diet (SMD 0.08, 95% CI 0.02 to 0.15; 11 RCTs, 16,649 participants; low-certainty evidence) and physical activity (SMD 0.09, 95% CI -0.02 to 0.19; 9 RCTs, 16,389 participants; low-certainty evidence). The effects on obesity probably suggest little to no difference (SMD -0.02, 95% CI -0.05 to 0.02; 8 RCTs, 18,618 participants; moderate-certainty evidence). The effects on tobacco use are very uncertain (SMD -0.03, 95% CIs -0.23 to 0.18; 3 RCTs, 3635 participants; very low-certainty evidence). One RCT assessed measures of student alcohol use and found strategies to support implementation may result in a slight increase in use (odds ratio 1.10, 95% CI 0.77 to 1.56; P = 0.60; 2105 participants). Few trials reported the economic evaluations of implementation strategies, the methods of which were heterogeneous and evidence graded as very uncertain. A lack of consistent terminology describing implementation strategies was an important limitation of the review. Authors' conclusions: The use of implementation strategies may result in large increases in implementation of interventions, and slight improvements in measures of student diet, and physical activity. Further research is required to assess the impact of implementation strategies on such behavioural- and obesity-related outcomes, including on measures of alcohol use, where the findings of one trial suggest it may slightly increase student risk. Given the low certainty of the available evidence for most measures further research is required to guide efforts to facilitate the translation of evidence into practice in this setting.

The Cochrane database of systematic reviews · systematic review · 35 citationsread the source →

Effectiveness of a brief lay counsellor-delivered, problem-solving intervention for adolescent mental health problems in urban, low-income schools in India: a randomised controlled trial.

Background: Mental health problems are a leading cause of disability in adolescents worldwide. Problem solving is a well-tested mental health intervention in many populations. We aimed to investigate the effectiveness of a brief, transdiagnostic problem-solving intervention for common adolescent mental health problems when delivered by non-specialist school counsellors in New Delhi, India. Methods: This randomised trial was done in six government-run schools (three all-boys schools, two all-girls schools, and one co-educational school) that serve low-income communities. We recruited participants from grades 9 to 12 (ages 12-20 years) by selecting students with persistently elevated mental health symptoms accompanied by distress or functional impairment. Clinical eligibility criteria were assessed by research assistants using the Hindi-language version of the Strengths and Difficulties Questionnaire (SDQ), with reference to locally validated borderline cutoff scores of 19 or greater for boys and 20 or greater for girls on the SDQ Total Difficulties scale, an abnormal score of 2 or more on the SDQ Impact scale, and persistence of more than 1 month on the SDQ Chronicity index. Participants were randomly allocated (1:1) to problem solving delivered through a brief (2-3 week) counsellor-led intervention with supporting printed materials (intervention group), or problem solving delivered via printed booklets alone (control group). Primary outcomes were adolescent-reported mental health symptoms (SDQ Total Difficulties scale) and idiographic psychosocial problems (Youth Top Problems [YTP]) at 6 weeks. Primary analyses were done on an intention-to-treat basis at the 6-week endpoint. The trial is registered with ClinicalTrials.gov, NCT03630471. Findings: Participants were enrolled between Aug 20, and Dec 4, 2018. 283 eligible adolescents were referred to the trial, and 251 (89%) of these were enrolled (mean age 15·61 years; 174 [69%] boys). 125 participants were allocated to each group (after accounting for one participant in the intervention group who withdrew consent after randomisation). Primary outcome data were available for 245 (98%) participants. At 6 weeks, the mean YTP scores were 3·52 (SD 2·66) in the intervention group and 4·60 (2·75) in the control group (adjusted mean difference -1·01, 95% CI -1·63 to -0·38; adjusted effect size 0·36, 95% CI 0·11 to 0·61; p=0·0015). The mean SDQ Total Difficulties scores were 17·48 (5·45) in the intervention group and 18·33 (5·45) in the control group (-0·86, -2·14 to 0·41; 0·16, -0·09 to 0·41; p=0·18). We observed no adverse events. Interpretation: A brief lay counsellor-delivered problem-solving intervention combined with printed booklets seemed to have a modest effect on psychosocial outcomes among adolescents with diverse mental health problems compared with problem-solving booklets alone. This counsellor-delivered intervention might be a suitable first-line intervention in a stepped care approach, which is being evaluated in ongoing studies. Funding: Wellcome Trust.

The Lancet. Child & adolescent health · randomised controlled trial · 69 citationsread the source →

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

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

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

Fall rates in hospital rehabilitation units after individualised patient and staff education programmes: a pragmatic, stepped-wedge, cluster-randomised controlled trial.

Background: Falls are the most frequent adverse events that are reported in hospitals. We examined the effectiveness of individualised falls-prevention education for patients, supported by training and feedback for staff, delivered as a ward-level programme. Methods: Eight rehabilitation units in general hospitals in Australia participated in this stepped-wedge, cluster-randomised study, undertaken during a 50 week period. Units were randomly assigned to intervention or control groups by use of computer-generated, random allocation sequences. We included patients admitted to the unit during the study with a Mini-Mental State Examination (MMSE) score of more than 23/30 to receive individualised education that was based on principles of changes in health behaviour from a trained health professional, in addition to usual care. We provided information about patients' goals, feedback about the ward environment, and perceived barriers to engagement in falls-prevention strategies to staff who were trained to support the uptake of strategies by patients. The coprimary outcome measures were patient rate of falls per 1000 patient-days and the proportion of patients who were fallers. All analyses were by intention to treat. This trial is registered with the Australian New Zealand Clinical Trials registry, number ACTRN12612000877886). Findings: Between Jan 13, and Dec 27, 2013, 3606 patients were admitted to the eight units (n=1983 control period; n=1623 intervention period). There were fewer falls (n=196, 7·80/1000 patient-days vs n=380, 13·78/1000 patient-days, adjusted rate ratio 0·60 [robust 95% CI 0·42-0·94], p=0·003), injurious falls (n=66, 2·63/1000 patient-days vs 131, 4·75/1000 patient-days, 0·65 [robust 95% CI 0·42-0·88], p=0·006), and fallers (n=136 [8·38%] vs n=248 [12·51%] adjusted odds ratio 0·55 [robust 95% CI 0·38 to 0·81], p=0·003) in the intervention compared with the control group. There was no significant difference in length of stay (intervention median 11 days [IQR 7-19], control 10 days [6-18]). Interpretation: Individualised patient education programmes combined with training and feedback to staff added to usual care reduces the rates of falls and injurious falls in older patients in rehabilitation hospital-units. Funding: State Health Research Advisory Council, Department of Health, Government of Western Australia.

Lancet (London, England) · randomised controlled trial · 143 citationsread the source →

Combined education and patient-led goal setting intervention reduced chronic low back pain disability and intensity at 12 months: a randomised controlled trial.

Background: One model of care that has not been tested for chronic low back pain (LBP) is patient-led goal setting. We aimed to compare the clinical effectiveness and healthcare use of a patient-led goal setting approach (intervention) with simple advice to exercise (control) over 12 months. Methods: An assessor-blinded randomised controlled trial. Intervention was education combined with patient-led goal setting compared with a control group receiving a standardised exercise programme. The primary outcomes were back pain disability and pain intensity. Secondary outcomes were quality of life, kinesiophobia, self-efficacy, depression, anxiety and stress. Outcomes and healthcare use were assessed immediately post-treatment (2 months) and after 4 and 12 months. Analysis was by intention to treat. Results: Seventy-five patients were randomly assigned to either the intervention (n=37) or the control (n=38) group. Using linear mixed model analyses, adjusted mean changes in primary outcomes of disability and pain intensity were greater in the intervention group than in the control group (disability post-treatment: p<0.05). These differences were clinically meaningful. Mean differences in all secondary measures were greater in the intervention group than in the control group (p<0.05). There was no difference in healthcare use between groups over 12 months. Conclusion: A patient-led goal setting intervention was significantly more effective than advice to exercise for improving outcomes in disability, pain intensity, quality of life, self-efficacy and kinesiophobia in chronic LBP. These improvements were maintained at 12 months. Smaller effects were seen in measures of depression, anxiety and stress. Trial registration number: ACTRN12614000830695.

British journal of sports medicine · randomised controlled trial · 65 citationsread the source →

A comparative analysis of analgesic efficacy of ultrasound and shock wave therapy in the treatment of patients with inflammation of the attachment of the plantar fascia in the course of calcaneal spurs.

Introduction: Troublesome heel spur is a nuisance condition that affects people of all ages. Treatment of patients with heel spur is a difficult and lengthy process requiring patience from both the patient and the therapist. Sometimes, the only and ultimate method of treatment is surgery, although spurs tend to recur. The aim of the study is a comparative analysis of the analgesic efficacy of ultrasound and shock wave therapy in patients with heel spur. The cause of pain in the course of calcaneal spur is inflammation of the attachment of the plantar fascia, which plays an important role in the process of walking and is seriously strained during different types of movement. Treatment of patients is a difficult and lengthy process. Materials and methods: The study was conducted on a group of 47 patients of both sexes, aged 38-60 years (mean 51.3) with a plantar calcaneal spur confirmed by X-ray images. Patients were randomly assigned into two groups using a simple randomization: Group 1-ultrasound therapy group (a series of ten treatments) and Group 2-the radial shock wave group (series of four treatments). In all patients, pain intensity was assessed three times: before therapy, after the first and second weeks of treatment. A version of Laitinen's pain assessment questionnaire and the Huskisson visual analogue scale (VAS) were used. Of the group of studied respondents, 47 patients of both sexes and aged 38-60 years (mean age 51.3) with a heel spur (confirmed on X-rays), who had pain for at least a month, were randomly included in the study. The patients were classified into: Group 1-US therapeutic group (a series of ten treatments) and Group 2-with RSWT (a series of five treatments). Pain intensity was assessed three times: before the treatment, after the first and second week of the treatment with the application of the VAS and the Leitinen Pain Questionnaire. Results: However, a decrease in pain sensation was reported in all test intervals, and its largest decrease occurred in both groups within 1 week of beginning treatment. More dynamic change in this period was recorded in Group 1. Conclusion: The conclusion is that while ultrasound and shock wave therapy show significant analgesic efficacy in patients with heel spur, fewer shock wave therapy sessions are needed than ultrasound sessions for effective relief, suggesting that the shock wave therapy has greater analgesic efficacy. A similar analgesic effect was achieved with the administration of a smaller number of shock wave treatments and a full series of ultrasound treatments.

Archives of orthopaedic and trauma surgery · randomised controlled trial · 19 citationsread the source →

Novel community health worker strategy for HIV service engagement in a hyperendemic community in Rakai, Uganda: A pragmatic, cluster-randomized trial.

Background: Effective implementation strategies are needed to increase engagement in HIV services in hyperendemic settings. We conducted a pragmatic cluster-randomized trial in a high-risk, highly mobile fishing community (HIV prevalence: approximately 38%) in Rakai, Uganda, to assess the impact of a community health worker-delivered, theory-based (situated Information, Motivation, and Behavior Skills), motivational interviewing-informed, and mobile phone application-supported counseling strategy called "Health Scouts" to promote engagement in HIV treatment and prevention services. Methods and findings: The study community was divided into 40 contiguous, randomly allocated clusters (20 intervention clusters, n = 1,054 participants at baseline; 20 control clusters, n = 1,094 participants at baseline). From September 2015 to December 2018, the Health Scouts were deployed in intervention clusters. Community-wide, cross-sectional surveys of consenting 15 to 49-year-old residents were conducted at approximately 15 months (mid-study) and at approximately 39 months (end-study) assessing the primary programmatic outcomes of self-reported linkage to HIV care, antiretroviral therapy (ART) use, and male circumcision, and the primary biologic outcome of HIV viral suppression (<400 copies/mL). Secondary outcomes included HIV testing coverage, HIV incidence, and consistent condom use. The primary intent-to-treat analysis used log-linear binomial regression with generalized estimating equation to estimate prevalence risk ratios (PRR) in the intervention versus control arm. A total of 2,533 (45% female, mean age: 31 years) and 1,903 (46% female; mean age 32 years) residents completed the mid-study and end-study surveys, respectively. At mid-study, there were no differences in outcomes between arms. At end-study, self-reported receipt of the Health Scouts intervention was 38% in the intervention arm and 23% in the control arm, suggesting moderate intervention uptake in the intervention arm and substantial contamination in the control arm. At end-study, intention-to-treat analysis found higher HIV care coverage (PRR: 1.06, 95% CI: 1.01 to 1.10, p = 0.011) and ART coverage (PRR: 1.05, 95% CI: 1.01 to 1.10, p = 0.028) among HIV-positive participants in the intervention compared with the control arm. Male circumcision coverage among all men (PRR: 1.05, 95% CI: 0.96 to 1.14, p = 0.31) and HIV viral suppression among HIV-positive participants (PRR: 1.04, 95% CI: 0.98 to 1.12, p = 0.20) were higher in the intervention arm, but differences were not statistically significant. No differences were seen in secondary outcomes. Study limitations include reliance on self-report for programmatic outcomes and substantial contamination which may have diluted estimates of effect. Conclusions: A novel community health worker intervention improved HIV care and ART coverage in an HIV hyperendemic setting but did not clearly improve male circumcision coverage or HIV viral suppression. This community-based, implementation strategy may be a useful component in some settings for HIV epidemic control. Trial registration: ClinicalTrials.gov NCT02556957.

PLoS medicine · randomised controlled trial · 20 citationsread the source →

Coached Mobile App Platform for the Treatment of Depression and Anxiety Among Primary Care Patients: A Randomized Clinical Trial.

Importance: Depression and anxiety are common and disabling. Primary care is the de facto site for treating these mental health problems but is typically underresourced to meet the burden of these demands. Objective: To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients. Design, setting, and participants: Two-arm randomized clinical trial at internal medicine clinics at the University of Arkansas for Medical Sciences. Adult primary care patients (N = 146) who screened positive for depression on the Patient Health Questionnaire-8 (PHQ; score  ≥ 10) or anxiety on the Generalized Anxiety Disorder-7 (GAD-7; score ≥ 8) were recruited between July 17, 2018, and December 14, 2018. Interventions: The coach-supported platform composed of a suite of apps, was delivered over 8 weeks. Wait list control participants received treatment as usual for 8 weeks, then the mobile platform. Main outcomes and measures: Primary outcomes were changes in depression (PHQ-9) and anxiety (GAD-7) during the intervention period. Secondary outcomes were differences in the proportion of patients who achieved recovery (PHQ-9/GAD-7 <5 or 50% improvement from baseline), sustainment of intervention effects during 2-month follow-up, and app use during the intervention period. Results: One hundred forty-six patients were included (119 of 146 were women [81.5%]; mean [SD] age, 42.3 [13.8] years). Of the 146 patients, 122 (83.6%) were diagnosed as having depression and 131 (89.7%) were diagnosed as having anxiety. A greater proportion of intervention vs wait list control participants achieved recovery from depression (n = 38 of 64 [59%] vs n = 18 of 58 [31%]; odds ratio, 3.25; 95% CI, 1.54-6.86) and anxiety (n = 37 of 65 [57%] vs n = 25 of 66 [38%]; odds ratio, 2.17; 95% CI, 1.08-4.36). Sustained effects were observed for depression (slope, 0.01; 95% CI, -0.09 to 0.10; P = .92) and anxiety scores (slope, 0.02; 95% CI, -0.08 to 0.12; P = .67) during follow-up. App use was high, with a median of 93 and 98 sessions among participants with depression and anxiety, respectively. Conclusions and relevance: In this trial, a mobile intervention app was effective for depression and anxiety among primary care patients. Findings also support designing digital mental health interventions as platforms containing simple, brief apps that can be bundled by users to meet their needs. Trial registration: ClinicalTrials.gov Identifier: NCT03500536.

JAMA psychiatry · randomised controlled trial · 122 citationsread the source →

Effect of Pain Neuroscience Education Combined With Cognition-Targeted Motor Control Training on Chronic Spinal Pain: A Randomized Clinical Trial.

Importance: Effective treatments for chronic spinal pain are essential to reduce the related high personal and socioeconomic costs. Objective: To compare pain neuroscience education combined with cognition-targeted motor control training with current best-evidence physiotherapy for reducing pain and improving functionality, gray matter morphologic features, and pain cognitions in individuals with chronic spinal pain. Design, setting, and participants: Multicenter randomized clinical trial conducted from January 1, 2014, to January 30, 2017, among 120 patients with chronic nonspecific spinal pain in 2 outpatient hospitals with follow-up at 3, 6, and 12 months. Interventions: Participants were randomized into an experimental group (combined pain neuroscience education and cognition-targeted motor control training) and a control group (combining education on back and neck pain and general exercise therapy). Main outcomes and measures: Primary outcomes were pain (pressure pain thresholds, numeric rating scale, and central sensitization inventory) and function (pain disability index and mental health and physical health). Results: There were 22 men and 38 women in the experimental group (mean [SD] age, 39.9 [12.0] years) and 25 men and 35 women in the control group (mean [SD] age, 40.5 [12.9] years). Participants in the experimental group experienced reduced pain (small to medium effect sizes): higher pressure pain thresholds at primary test site at 3 months (estimated marginal [EM] mean, 0.971; 95% CI, -0.028 to 1.970) and reduced central sensitization inventory scores at 6 months (EM mean, -5.684; 95% CI, -10.589 to -0.780) and 12 months (EM mean, -6.053; 95% CI, -10.781 to -1.324). They also experienced improved function (small to medium effect sizes): significant and clinically relevant reduction of disability at 3 months (EM mean, -5.113; 95% CI, -9.994 to -0.232), 6 months (EM mean, -6.351; 95% CI, -11.153 to -1.550), and 12 months (EM mean, -5.779; 95% CI, -10.340 to -1.217); better mental health at 6 months (EM mean, 36.496; 95% CI, 7.998-64.995); and better physical health at 3 months (EM mean, 39.263; 95% CI, 9.644-66.882), 6 months (EM mean, 53.007; 95% CI, 23.805-82.209), and 12 months (EM mean, 32.208; 95% CI, 2.402-62.014). Conclusions and relevance: Pain neuroscience education combined with cognition-targeted motor control training appears to be more effective than current best-evidence physiotherapy for improving pain, symptoms of central sensitization, disability, mental and physical functioning, and pain cognitions in individuals with chronic spinal pain. Significant clinical improvements without detectable changes in brain gray matter morphologic features calls into question the relevance of brain gray matter alterations in this population. Trial registration: clinicaltrials.gov Identifier: NCT02098005.

JAMA neurology · randomised controlled trial · 193 citationsread the source →

Effect of a Workplace Wellness Program on Employee Health and Economic Outcomes: A Randomized Clinical Trial.

Importance: Employers have increasingly invested in workplace wellness programs to improve employee health and decrease health care costs. However, there is little experimental evidence on the effects of these programs. Objective: To evaluate a multicomponent workplace wellness program resembling programs offered by US employers. Design, setting, and participants: This clustered randomized trial was implemented at 160 worksites from January 2015 through June 2016. Administrative claims and employment data were gathered continuously through June 30, 2016; data from surveys and biometrics were collected from July 1, 2016, through August 31, 2016. Interventions: There were 20 randomly selected treatment worksites (4037 employees) and 140 randomly selected control worksites (28 937 employees, including 20 primary control worksites [4106 employees]). Control worksites received no wellness programming. The program comprised 8 modules focused on nutrition, physical activity, stress reduction, and related topics implemented by registered dietitians at the treatment worksites. Main outcomes and measures: Four outcome domains were assessed. Self-reported health and behaviors via surveys (29 outcomes) and clinical measures of health via screenings (10 outcomes) were compared among 20 intervention and 20 primary control sites; health care spending and utilization (38 outcomes) and employment outcomes (3 outcomes) from administrative data were compared among 20 intervention and 140 control sites. Results: Among 32 974 employees (mean [SD] age, 38.6 [15.2] years; 15 272 [45.9%] women), the mean participation rate in surveys and screenings at intervention sites was 36.2% to 44.6% (n = 4037 employees) and at primary control sites was 34.4% to 43.0% (n = 4106 employees) (mean of 1.3 program modules completed). After 18 months, the rates for 2 self-reported outcomes were higher in the intervention group than in the control group: for engaging in regular exercise (69.8% vs 61.9%; adjusted difference, 8.3 percentage points [95% CI, 3.9-12.8]; adjusted P = .03) and for actively managing weight (69.2% vs 54.7%; adjusted difference, 13.6 percentage points [95% CI, 7.1-20.2]; adjusted P = .02). The program had no significant effects on other prespecified outcomes: 27 self-reported health outcomes and behaviors (including self-reported health, sleep quality, and food choices), 10 clinical markers of health (including cholesterol, blood pressure, and body mass index), 38 medical and pharmaceutical spending and utilization measures, and 3 employment outcomes (absenteeism, job tenure, and job performance). Conclusions and relevance: Among employees of a large US warehouse retail company, a workplace wellness program resulted in significantly greater rates of some positive self-reported health behaviors among those exposed compared with employees who were not exposed, but there were no significant differences in clinical measures of health, health care spending and utilization, and employment outcomes after 18 months. Although limited by incomplete data on some outcomes, these findings may temper expectations about the financial return on investment that wellness programs can deliver in the short term. Trial registration: ClinicalTrials.gov Identifier: NCT03167658.

JAMA · randomised controlled trial · 170 citationsread the source →

A Randomized Trial of a Bereavement Intervention for Pregnancy Loss.

Objective: To examine the effects of a secondary bereavement intervention on grieving in women who experienced a miscarriage (pregnancy loss) at 12-20 weeks gestation. Design: Experimental, posttest only, control group design. Setting: Obstetric emergency center of a county hospital in a large city. Participants: Forty women who experienced complete spontaneous miscarriages in the first or second trimester (8-20 weeks gestation). Methods: Participants were randomly assigned to the grief intervention treatment group or usual standard care control group. The Medical Professional Guidelines for Health Care Professionals were used to construct the perinatal grief intervention. The Perinatal Grief Scale (PGS) was completed during a routine follow-up visit 2 weeks postloss. Results: A one-way multiple ANOVA (MANOVA) was used to examine the difference in grieving between the control and experimental groups. Three dependent variables were used: despair, difficulty coping, and active grieving. Analysis revealed a significant difference on the combined dependent variables, F(3, 36) = 22.40, p < .000. When considering the three dependent variables separately, the treatment group displayed significantly lower levels of despair, F(1, 38) = 42.27, p < .001. Active grieving was high in both groups with the treatment group mean higher than the control group. Group means were similar for coping difficulty. Conclusion: A bereavement intervention administered immediately after the miscarriage promotes women's ability to cope with early pregnancy loss.

Journal of obstetric, gynecologic, and neonatal nursing : JOGNN · randomised controlled trial · 32 citationsread the source →

Efficacy of the Mindfulness Meditation Mobile App “Calm” to Reduce Stress Among College Students: Randomized Controlled Trial

BACKGROUND: College students experience high levels of stress. Mindfulness meditation delivered via a mobile app may be an appealing, efficacious way to reduce stress in college students. OBJECTIVE: We aimed to test the initial efficacy and sustained effects of an 8-week mindfulness meditation mobile app-Calm-compared to a wait-list control on stress, mindfulness, and self-compassion in college students with elevated stress. We also explored the intervention's effect on health behaviors (ie, sleep disturbance, alcohol consumption [binge drinking], physical activity, and healthy eating [fruit and vegetable consumption]) and the feasibility and acceptability of the app. METHODS: This study was a randomized, wait-list, control trial with assessments at baseline, postintervention (8 weeks), and at follow-up (12 weeks). Participants were eligible if they were current full-time undergraduate students and (1) at least 18 years of age, (2) scored ≥14 points on the Perceived Stress Scale, (3) owned a smartphone, (4) were willing to download the Calm app, (5) were willing to be randomized, and (7) were able to read and understand English. Participants were asked to meditate using Calm at least 10 minutes per day. A P value ≤.05 was considered statistically significant. RESULTS: A total of 88 participants were included in the analysis. The mean age (SD) was 20.41 (2.31) years for the intervention group and 21.85 (6.3) years for the control group. There were significant differences in all outcomes (stress, mindfulness, and self-compassion) between the intervention and control groups after adjustment for covariates postintervention (all P<.04). These effects persisted at follow-up (all P<.03), except for the nonreacting subscale of mindfulness (P=.08). There was a significant interaction between group and time factors in perceived stress (P=.002), mindfulness (P<.001), and self-compassion (P<.001). Bonferroni posthoc tests showed significant within-group mean differences for perceived stress in the intervention group (P<.001), while there were no significant within-group mean differences in the control group (all P>.19). Similar results were found for mindfulness and self-compassion. Effect sizes ranged from moderate (0.59) to large (1.24) across all outcomes. A significant group×time interaction in models of sleep disturbance was found, but no significant effects were found for other health behaviors. The majority of students in the intervention group reported that Calm was helpful to reduce stress and stated they would use Calm in the future. The majority were satisfied using Calm and likely to recommend it to other college students. The intervention group participated in meditation for an average of 38 minutes/week during the intervention and 20 minutes/week during follow-up. CONCLUSIONS: Calm is an effective modality to deliver mindfulness meditation in order to reduce stress and improve mindfulness and self-compassion in stressed college students. Our findings provide important information that can be applied to the design of future studies or mental health resources in university programs. TRIAL REGISTRATION: ClinicalTrials.gov NCT03891810; https://clinicaltrials.gov/ct2/show/NCT03891810.

JMIR mhealth and uhealth · randomised controlled trial · 506 citationsread the source →