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Cost-effectiveness and economic returns of group-based parenting interventions to promote early childhood development: Results from a randomized controlled trial in rural Kenya.

Background: Early childhood development (ECD) programs can help address disadvantages for the 43% of children under 5 in low- and middle-income countries (LMICs) experiencing compromised development. However, very few studies from LMIC settings include information on their program's cost-effectiveness or potential returns to investment. We estimated the cost-effectiveness, benefit-cost ratios (BCRs), and returns on investment (ROIs) for 2 effective group-based delivery models of an ECD parenting intervention that utilized Kenya's network of local community health volunteers (CHVs). Methods and findings: Between October 1 and November 12, 2018, 1,152 mothers with children aged 6 to 24 months were surveyed from 60 villages in rural western Kenya. After baseline, villages were randomly assigned to one of 3 intervention arms: a group-only delivery model with 16 fortnightly sessions, a mixed-delivery model combining 12 group sessions with 4 home visits, and a control group. At endline (August 5 to October 31, 2019), 1,070 children were retained and assessed for primary outcomes including cognitive and receptive language development (with the Bayley Scales of Infant Development, Third Edition) and socioemotional development (with the Wolke scale). Children in the 2 intervention arms showed better developmental outcomes than children in the control arm, although the group-only delivery model generally had larger effects on children. Total program costs included provider's implementation costs collected during the intervention period using financial reports from the local nongovernmental organization (NGO) implementer, as well as societal costs such as opportunity costs to mothers and delivery agents. We combined program impacts with these total costs to estimate incremental cost-effectiveness ratios (ICERs), as well as BCRs and the program's ROI for the government based on predictions of future lifetime wages and societal costs. Total costs per child were US$140 in the group-only arm and US$145 in the mixed-delivery arm. Because of higher intention-to-treat (ITT) impacts at marginally lower costs, the group-only model was the most cost-effective across all child outcomes. Focusing on child cognition in this arm, we estimated an ICER of a 0.37 standard deviation (SD) improvement in cognition per US$100 invested, a BCR of 15.5, and an ROI of 127%. A limitation of our study is that our estimated BCR and ROI necessarily make assumptions about the discount rate, income tax rates, and predictions of intervention impacts on future wages and schooling. We examine the sensitivity of our results to these assumptions. Conclusions: To the best of our knowledge, this study is the first economic evaluation of an effective ECD parenting intervention targeted to young children in sub-Saharan Africa (SSA) and the first to adopt a societal perspective in calculating cost-effectiveness that accounts for opportunity costs to delivery agents and program participants. Our cost-effectiveness and benefit-cost estimates are higher than most of the limited number of prior studies from LMIC settings providing information about costs. Our results represent a strong case for scaling similar interventions in impoverished rural settings, and, under reasonable assumptions about the future, demonstrate that the private and social returns of such investments are likely to largely outweigh their costs. Trial registration: This trial is registered at ClinicalTrials.gov, NCT03548558, June 7, 2018. American Economic Association RCT Registry trial AEARCTR-0002913.

PLoS medicine · randomised controlled trial · 24 citationsread the source →

Feasibility and impact of a mental health chatbot on postpartum mental health: a randomized controlled trial.

Background: Perinatal mood disorders are common yet underdiagnosed and un- or undertreated. Barriers exist to accessing perinatal mental health services, including limited availability, time, and cost. Automated conversational agents (chatbots) can deliver evidence-based cognitive behavioral therapy content through text message-based conversations and reduce depression and anxiety symptoms in select populations. Such digital mental health technologies are poised to overcome barriers to mental health care access but need to be evaluated for efficacy, as well as for preliminary feasibility and acceptability among perinatal populations. Objective: To evaluate the acceptability and preliminary efficacy of a mental health chatbot for mood management in a general postpartum population. Study design: An unblinded randomized controlled trial was conducted at a tertiary academic center. English-speaking postpartum women aged 18 years or above with a live birth and access to a smartphone were eligible for enrollment prior to discharge from delivery hospitalization. Baseline surveys were administered to all participants prior to randomization to a mental health chatbot intervention or to usual care only. The intervention group downloaded the mental health chatbot smartphone application with perinatal-specific content, in addition to continuing usual care. Usual care consisted of routine postpartum follow up and mental health care as dictated by the patient's obstetric provider. Surveys were administered during delivery hospitalization (baseline) and at 2-, 4-, and 6-weeks postpartum to assess depression and anxiety symptoms. The primary outcome was a change in depression symptoms at 6-weeks as measured using two depression screening tools: Patient Health Questionnaire-9 and Edinburgh Postnatal Depression Scale. Secondary outcomes included anxiety symptoms measured using Generalized Anxiety Disorder-7, and satisfaction and acceptability using validated scales. Based on a prior study, we estimated a sample size of 130 would have sufficient (80%) power to detect a moderate effect size (d=.4) in between group difference on the Patient Health Questionnaire-9. Results: A total of 192 women were randomized equally 1:1 to the chatbot or usual care; of these, 152 women completed the 6-week survey (n=68 chatbot, n=84 usual care) and were included in the final analysis. Mean baseline mental health assessment scores were below positive screening thresholds. At 6-weeks, there was a greater decrease in Patient Health Questionnaire-9 scores among the chatbot group compared to the usual care group (mean decrease=1.32, standard deviation=3.4 vs mean decrease=0.13, standard deviation=3.01, respectively). 6-week mean Edinburgh Postnatal Depression Scale and Generalized Anxiety Disorder-7 scores did not differ between groups and were similar to baseline. 91% (n=62) of the chatbot users were satisfied or highly satisfied with the chatbot, and 74% (n=50) of the intervention group reported use of the chatbot at least once in 2 weeks prior to the 6-week survey. 80% of study participants reported being comfortable with the use of a mobile smartphone application for mood management. Conclusion: Use of a chatbot was acceptable to women in the early postpartum period. The sample did not screen positive for depression at baseline and thus the potential of the chatbot to reduce depressive symptoms in this population was limited. This study was conducted in a general obstetric population. Future studies of longer duration in high-risk postpartum populations who screen positive for depression are needed to further understand the utility and efficacy of such digital therapeutics for that population.

AJOG global reports · 48 citationsread the source →

Interventions for fatigue in people with kidney failure requiring dialysis.

Background: Fatigue is a common and debilitating symptom in people receiving dialysis that is associated with an increased risk of death, cardiovascular disease and depression. Fatigue can also impair quality of life (QoL) and the ability to participate in daily activities. Fatigue has been established by patients, caregivers and health professionals as a core outcome for haemodialysis (HD). Objectives: We aimed to evaluate the effects of pharmacological and non-pharmacological interventions on fatigue in people with kidney failure receiving dialysis, including HD and peritoneal dialysis (PD), including any setting and frequency of the dialysis treatment. Search methods: We searched the Cochrane Kidney and Transplant Register of Studies up to 18 October 2022 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Registry Platform (ICTRP) Search Portal and ClinicalTrials.gov. Selection criteria: Studies evaluating pharmacological and non-pharmacological interventions affecting levels of fatigue or fatigue-related outcomes in people receiving dialysis were included. Studies were eligible if fatigue or fatigue-related outcomes were reported as a primary or secondary outcome. Any mode, frequency, prescription, and duration of therapy were considered. Data collection and analysis: Three authors independently extracted data and assessed the risk of bias. Treatment estimates were summarised using random effects meta-analysis and expressed as a risk ratio (RR) or mean difference (MD), with a corresponding 95% confidence interval (CI) or standardised MD (SMD) if different scales were used. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Main results: Ninety-four studies involving 8191 randomised participants were eligible. Pharmacological and non-pharmacological interventions were compared either to placebo or control, or to another pharmacological or non-pharmacological intervention. In the majority of domains, risks of bias in the included studies were unclear or high. In low certainty evidence, when compared to control, exercise may improve fatigue (4 studies, 217 participants (Iowa Fatigue Scale, Modified Fatigue Impact Scale, Piper Fatigue Scale (PFS), or Haemodialysis-Related Fatigue scale score): SMD -1.18, 95% CI -2.04 to -0.31; I2 = 87%) in HD. In low certainty evidence, when compared to placebo or standard care, aromatherapy may improve fatigue (7 studies, 542 participants (Fatigue Severity Scale (FSS), Rhoten Fatigue Scale (RFS), PFS or Brief Fatigue Inventory score): SMD -1.23, 95% CI -1.96 to -0.50; I2 = 93%) in HD. In low certainty evidence, when compared to no intervention, massage may improve fatigue (7 studies, 657 participants (FSS, RFS, PFS or Visual Analogue Scale (VAS) score): SMD -1.06, 95% CI -1.47, -0.65; I2 = 81%) and increase energy (2 studies, 152 participants (VAS score): MD 4.87, 95% CI 1.69 to 8.06, I2 = 59%) in HD. In low certainty evidence, when compared to placebo or control, acupressure may reduce fatigue (6 studies, 459 participants (PFS score, revised PFS, or Fatigue Index): SMD -0.64, 95% CI -1.03 to -0.25; I2 = 75%) in HD. A wide range of heterogenous interventions and fatigue-related outcomes were reported for exercise, aromatherapy, massage and acupressure, preventing our capability to pool and analyse the data. Due to the paucity of studies, the effects of pharmacological and other non-pharmacological interventions on fatigue or fatigue-related outcomes, including non-physiological neutral amino acid, relaxation with or without music therapy, meditation, exercise with nandrolone, nutritional supplementation, cognitive-behavioural therapy, ESAs, frequent HD sections, home blood pressure monitoring, blood flow rate reduction, serotonin reuptake inhibitor, beta-blockers, anabolic steroids, glucose-enriched dialysate, or light therapy, were very uncertain. The effects of pharmacological and non-pharmacological treatments on death, cardiovascular diseases, vascular access, QoL, depression, anxiety, hypertension or diabetes were sparse. No studies assessed tiredness, exhaustion or asthenia. Adverse events were rarely and inconsistently reported. Authors' conclusions: Exercise, aromatherapy, massage and acupressure may improve fatigue compared to placebo, standard care or no intervention. Pharmacological and other non-pharmacological interventions had uncertain effects on fatigue or fatigue-related outcomes in people receiving dialysis. Future adequately powered, high-quality studies are likely to change the estimated effects of interventions for fatigue and fatigue-related outcomes in people receiving dialysis.

The Cochrane database of systematic reviews · meta-analysis · 16 citationsread the source →

Efficacy of school-based interventions aimed at decreasing sugar-sweetened beverage consumption among adolescents: a systematic review.

Objective: To verify the efficacy of school-based interventions aimed at reducing sugar-sweetened beverage (SSB) consumption among adolescents in order to develop or improve public health interventions. Design: Systematic review of interventions targeting adolescents and/or the school environment. Setting: The following databases were investigated: MEDLINE/PubMed, PsycINFO, CINAHL and EMBASE. Proquest Dissertations and Theses was also investigated for unpublished trials. Subjects: Adolescents were defined as individuals between the ages of 12 and 17 years. Results: A total of thirty-six studies detailing thirty-six different interventions tested among independent samples (n 152 001) were included in the review. Twenty interventions were classified as educational/behavioural and ten were classified as legislative/environmental interventions. Only six interventions targeted both individuals and their environment. Over 70 % of all interventions, regardless of whether they targeted individuals, their environment or both, were effective in decreasing SSB consumption. Legislative/environmental studies had the highest success rate (90·0 %). Educational/behavioural interventions only and interventions that combined educational/behavioural and legislative/environmental approaches were almost equally effective in reducing SSB consumption with success rates of 65·0 and 66·7 %, respectively. Among the interventions that had an educational/behavioural component, 61·5 % were theory-based. The behaviour change techniques most frequently used in interventions were providing information about the health consequences of performing the behaviour (72·2 %), restructuring the physical environment (47·2 %), behavioural goal setting (36·1 %), self-monitoring of behaviour (33·3 %), threat to health (30·6 %) and providing general social support (30·6 %). Conclusions: School-based interventions show promising results to reduce SSB consumption among adolescents. A number of recommendations are made to improve future studies.

Public health nutrition · meta-analysis · 69 citationsread the source →

A Mediterranean-style dietary intervention supplemented with fish oil improves diet quality and mental health in people with depression: A randomized controlled trial (HELFIMED).

Objectives: We investigated whether a Mediterranean-style diet (MedDiet) supplemented with fish oil can improve mental health in adults suffering depression. Methods: Adults with self-reported depression were randomized to receive fortnightly food hampers and MedDiet cooking workshops for 3 months and fish oil supplements for 6 months, or attend social groups fortnightly for 3 months. Assessments at baseline, 3 and 6 months included mental health, quality of life (QoL) and dietary questionnaires, and blood samples for erythrocyte fatty acid analysis. Results: n = 152 eligible adults aged 18-65 were recruited (n = 95 completed 3-month and n = 85 completed 6-month assessments). At 3 months, the MedDiet group had a higher MedDiet score (t = 3.95, P < 0.01), consumed more vegetables (t = 3.95, P < 0.01), fruit (t = 2.10, P = 0.04), nuts (t = 2.29, P = 0.02), legumes (t = 2.41, P = 0.02) wholegrains (t = 2.63, P = 0.01), and vegetable diversity (t = 3.27, P < 0.01); less unhealthy snacks (t = -2.10, P = 0.04) and red meat/chicken (t = -2.13, P = 0.04). The MedDiet group had greater reduction in depression (t = -2.24, P = 0.03) and improved mental health QoL scores (t = 2.10, P = 0.04) at 3 months. Improved diet and mental health were sustained at 6 months. Reduced depression was correlated with an increased MedDiet score (r = -0.298, P = 0.01), nuts (r = -0.264, P = 0.01), and vegetable diversity (r = -0.303, P = 0.01). Other mental health improvements had similar correlations, most notably for increased vegetable diversity and legumes. There were some correlations between increased omega-3, decreased omega-6 and improved mental health. Discussion: This is one of the first randomized controlled trials to show that healthy dietary changes are achievable and, supplemented with fish oil, can improve mental health in people with depression.

Nutritional neuroscience · randomised controlled trial · 365 citationsread the source →

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

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

JAMA · randomised controlled trial · 42 citationsread the source →

Efficacy of a transdiagnostic Internet prevention approach in adolescents (EMPATIA study): study protocol of a randomized controlled trial.

Background: Most mental disorders have their onset in adolescence. Preventive interventions during this period are important; however, help-seeking behavior is generally poor in this age group resulting in low treatment rates. Internet interventions are expected to be an effective, low-threshold, and scalable approach to overcome barriers to help-seeking, particularly for individuals experiencing subclinical symptoms. Internet-delivered indicated prevention seems promising as it targets individuals with minimal symptoms of mental disorders who might need care but are not help-seeking yet. Previous indicated prevention-approaches have mainly targeted specific risk-syndromes. However, this contradicts the increasing recognition of emerging psychopathology as a complex system characterized by co-occurrence and rapid shifts of subclinical symptoms cutting across diagnostic categories. Therefore, this study will investigate the efficacy, mediators, moderators, and core symptomatic changes of a transdiagnostic Internet-delivered indicated prevention program (EMPATIA program) for adolescents. Methods: This randomized controlled trial (RCT) will be conducted in a general population sample (planned n = 152) of adolescents aged 12-18 years with subclinical symptoms but without any current or past mental disorder. Participants will be randomly assigned to the EMPATIA program or a care as usual (CAU) control condition. The 8-week guided EMPATIA program encompasses 8 modules targeting the following transdiagnostic mechanisms: repetitive negative thinking, self-perfectionism, emotion regulation, intolerance of uncertainty, rejection sensitivity, and behavioral avoidance. Participants will be asked to answer online self-report questionnaires at baseline, after 8 weeks, and at 6-, 9-, and 12-month follow-up. Diagnostic telephone interviews will be conducted at baseline and at 12-month follow-up. Additionally, intervention-specific constructs (motivation, alliance, negative effects, satisfaction, adherence) will be assessed during and after the EMPATIA program. The level of self-reported general psychopathology post-intervention is the primary outcome. Discussion: Results will be discussed considering the potential of Internet interventions as a scalable, low-threshold option for indicated prevention in adolescents experiencing subclinical symptoms. The EMPATIA program introduces a novel Internet prevention program targeting six transdiagnostic mechanisms associated with various mental health outcomes. Thereby, this trial pursues a very timely and important topic because it may contribute to narrow the current care gap for adolescents, to prevent mental health problems and related negative consequences, and to promote mental health in the long-term. Trial registration: The trial was approved by Swissmedic (Registration Number: 10001035, 08/22/2022) and the Ethics Committee of Bern (Registration Number: 2022-D0036, 08/22/2022). The trial was registered at ClinicalTrials.gov NCT05934019 on 07-03-2023.

Trials · clinical trialread the source →

Self-management and peer support among people with arthritis on a hospital joint replacement waiting list: a randomised controlled trial.

Introduction: To evaluate the efficacy of a self-management support program including a 6 week self-management course, individualised phone support and goal setting in osteoarthritis patients on a waiting list for arthroplasty surgery. Method: Randomised controlled trial of 152 public hospital outpatients awaiting hip or knee replacement surgery who were not classified as requiring urgent surgery. Participants were randomised to a self-management program or to usual care. The primary outcome was change in the Health Education Intervention Questionnaire (HeiQ) from randomisation to 6 month follow-up. Quality of life and depressive symptoms were also measured. Changes in pain and function were assessed using the Western Ontario and McMaster Universities (WOMAC) Arthritis Index. Results: At 6 month follow-up, health-directed behaviour was significantly greater in the intervention [mean 4.29, 95% confidence interval (CI) 3.99-4.58] than the control (mean 3.81, 95% CI 3.52-4.09; P=0.017). There was also a significant effect on skill and technique acquisition for the intervention (mean 4.37, 95% CI 4.19-4.55) in comparison to control (mean 4.11, 95% CI 3.93-4.29; P=0.036). There was no significant effect of the intervention on the remaining HeiQ subscales, WOMAC pain or disability, quality of life or depressive symptoms. Discussion: The arthritis self-management program improved health-directed behaviours, skill acquisition and stiffness in patients on a joint replacement waiting list, although the observed effects were of modest size (Cohen's d between 0.36 and 0.42). There was no significant effect on pain, function or quality of life in the short term. Self-management programs can assist in maintaining health behaviours (particularly walking) in this patient group. Further research is needed to assess their impact on quality of life and over longer periods.

Osteoarthritis and cartilage · randomised controlled trial · 52 citationsread the source →

Poor vitamin C status is associated with increased depression symptoms following acute illness in older people.

Background: Vitamin C has important physical and mental health benefits and plasma concentrations reflect recent intakes. Inflammation associated with any acute illness can lead to poor appetite and low food intake in older people. The aims of this report were to assess the prevalence and clinical significance of vitamin C deficiency among hospitalized acutely-ill older patients. Methods: Three hundred and twenty two patients (152 [47%] female), aged 65 yrs. and over who took part in a randomized, double blind, placebo-controlled trial had their nutritional status assessed from anthropometric, hematological and biochemical data at baseline, and after 6 weeks and 6 months. Vitamin C was measured using a fluorimetric technique and logistic regression analysis was performed to determine the influence of a number of clinical indicators, including tissue inflammation measured using C-reactive protein on vitamin C concentrations. Clinical outcome measures including symptoms of depression were also compared between patients with vitamin C deficiency and those with normal levels. Results: At baseline, 116 (36%) patients had a vitamin C concentration below 11 µmol/L indicating biochemical depletion. The figures at 6 weeks and 6 months were 28 (22%) and 44 (28%) patients, respectively. Older age, male gender, smoking, increased dependency and tissue inflammation were associated with lower vitamin C concentrations. Patients with vitamin C biochemical depletion had significantly increased symptoms of depression compared with those with higher concentrations at baseline (p=0.035) and at 6 weeks (p=0.028). Conclusions: A high proportion of older patients had sub-optimal vitamin C status and this was associated with increased symptoms of depression.

International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition · randomised controlled trial · 37 citationsread the source →

Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock (IABP-SHOCK II): final 12 month results of a randomised, open-label trial.

Background: In current international guidelines the recommendation for intra-aortic balloon pump (IABP) use has been downgraded in cardiogenic shock complicating acute myocardial infarction on the basis of registry data. In the largest randomised trial (IABP-SHOCK II), IABP support did not reduce 30 day mortality compared with control. However, previous trials in cardiogenic shock showed a mortality benefit only at extended follow-up. The present analysis therefore reports 6 and 12 month results. Methods: The IABP-SHOCK II trial was a randomised, open-label, multicentre trial. Patients with cardiogenic shock complicating acute myocardial infarction who were undergoing early revascularisation and optimum medical therapy were randomly assigned (1:1) to IABP versus control via a central web-based system. The primary efficacy endpoint was 30 day all-cause mortality, but 6 and 12 month follow-up was done in addition to quality-of-life assessment for all survivors with the Euroqol-5D questionnaire. A masked central committee adjudicated clinical outcomes. Patients and investigators were not masked to treatment allocation. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, NCT00491036. Findings: Between June 16, 2009, and March 3, 2012, 600 patients were assigned to IABP (n=301) or control (n=299). Of 595 patients completing 12 month follow-up, 155 (52%) of 299 patients in the IABP group and 152 (51%) of 296 patients in the control group had died (relative risk [RR] 1·01, 95% CI 0·86-1·18, p=0·91). There were no significant differences in reinfarction (RR 2·60, 95% CI 0·95-7·10, p=0·05), recurrent revascularisation (0·91, 0·58-1·41, p=0·77), or stroke (1·50, 0·25-8·84, p=1·00). For survivors, quality-of-life measures including mobility, self-care, usual activities, pain or discomfort, and anxiety or depression did not differ significantly between study groups. Interpretation: In patients undergoing early revascularisation for myocardial infarction complicated by cardiogenic shock, IABP did not reduce 12 month all-cause mortality. Funding: German Research Foundation; German Heart Research Foundation; German Cardiac Society; Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte; University of Leipzig--Heart Centre; Maquet Cardiopulmonary; Teleflex Medical.

Lancet (London, England) · randomised controlled trial · 641 citationsread the source →

Premature mortality attributable to socioeconomic inequality in England between 2003 and 2018: an observational study.

Background: Low socioeconomic position is consistently associated with increased risk of premature death. The aim of this study is to measure the aggregate scale of inequality in premature mortality for the whole population of England. Methods: We used mortality records from the UK Office for National Statistics to study all 2 465 285 premature deaths (defined as those before age 75 years) in England between Jan 1, 2003, and Dec 31, 2018. Socioeconomic position was defined using deciles of the Index of Multiple Deprivation: a measure of neighbourhood income, employment, education levels, crime, health, availability of services, and local environment. We calculated the number of expected deaths by applying mortality in the least deprived decile to other deciles, within the strata of age, sex, and time. The mortality attributable to socioeconomic inequality was defined as the difference between the observed and expected deaths. We also used life table modelling to estimate years-of-life lost attributable to socioeconomic inequality. Findings: 35·6% (95% CI 35·3-35·9) of premature deaths were attributable to socioeconomic inequality, equating to 877 082 deaths, or one every 10 min. The biggest contributors were ischaemic heart disease (152 171 excess deaths), respiratory cancers (111 083) and chronic obstructive pulmonary disease (83 593). The most unequal causes of death were tuberculosis, opioid use, HIV, psychoactive drugs use, viral hepatitis, and obesity, each with more than two-thirds attributable to inequality. Inequality was greater among men and peaked in early childhood and at age 40-49 years. The proportion of deaths attributable to inequality increased during the study period, particularly for women, because mortality rates among the most deprived women (excluding cardiovascular diseases) plateaued, and for some diseases increased. A mean of 14·4 months of life before age 75 years are lost due to socioeconomic inequality. Interpretation: One in three premature deaths are attributable to socioeconomic inequality, making this our most important public health challenge. Interventions that address upstream determinants of health should be prioritised. Funding: National Institute of Health Research; Wellcome Trust.

The Lancet. Public health · cohort or longitudinal · 143 citationsread the source →

Do illness perceptions predict pain-related disability and mood in chronic orofacial pain patients? A 6-month follow-up study.

Unlabelled: In our study, we investigated the predictive value of illness beliefs as measured by the revised illness perception questionnaire (IPQ-R) in the context of other clinical predictors in patients with chronic orofacial pain over a 6-month follow-up period. Consecutive patients (152) referred to the interdisciplinary orofacial pain service at the Centre for Dental and Oral Medicine and Cranio-Maxillofacial Surgery, University of Zurich received questionnaires to assess pain and pain-related disability, anxiety, depression as well as physical and mental quality of life at three time points: prior to treatment, 3 and 6 months after beginning of treatment. Results: significant improvement was found over time for all outcome measures except mental quality of life. RESULTS of the regression analysis indicated that believing pain could have serious consequences on one's life (IPQ subscale consequences) is one of the most important predictors for treatment outcome. The belief in low personal control and in a chronic timeline is also shown to be predictive for outcome, though explaining a smaller proportion of variance. These results provided evidence that beliefs about pain are important predictors for treatment outcome even when controlled for pain and mood. They therefore need to be considered in the management of patients with chronic orofacial pain. Assessing patients' illness beliefs can provide essential information on these important psychological determinants of adjustment to chronic pain and may be specific targets for individualised treatment approaches.

European journal of pain (London, England) · 60 citationsread the source →

The effect of metabolic syndrome components on exercise performance in patients with intermittent claudication.

Purpose: To determine the effect of metabolic syndrome components on intermittent claudication, physical function, health-related quality of life, and peripheral circulation in patients with peripheral arterial disease (PAD), and to identify the metabolic syndrome components most predictive of each outcome measure. Methods: Patients limited by intermittent claudication with three (n = 48), four (n = 45), or five (n = 40) components of metabolic syndrome were studied. Patients were assessed on PAD-specific measures consisting of ankle-brachial index (ABI), initial claudication distance, absolute claudication distance, physical function measures, health-related quality of life, and calf blood flow and transcutaneous oxygen tension responses after 3 minutes of vascular occlusion. Results: Initial claudication distance (mean +/- SD) progressively declined (P = .019) in those with three (203 +/- 167 m), four (124 +/- 77 m), and five (78 +/- 57 m) metabolic syndrome components, and absolute claudication distance progressively declined (P = .036) in these groups as well (414 +/- 224 m vs 323 +/- 153 m vs 249 +/- 152 m, respectively). Furthermore, compared with patients with only three components of metabolic syndrome, those with all five components had impaired values (P < .05) for peak oxygen uptake, ischemic window, 6-minute walk distance, self-perceived walking ability and health, daily physical activity, health-related quality of life on six of eight domains, calf hyperemia, and calf ischemia after vascular occlusion. Abdominal obesity was the predictor (P < .05) of exercise performance during the treadmill and 6-minute walk tests, as well as physical activity. Elevated fasting glucose was the predictor (P < .05) of peripheral vascular measures, self-perceived walking ability and health, and health-related quality of life. Conclusion: PAD patients with more metabolic syndrome components have worsened intermittent claudication, physical function, health-related quality of life, and peripheral circulation. Abdominal obesity and elevated fasting glucose are the metabolic syndrome components that are most predictive of these outcome measures. Aggressively treating these metabolic syndrome components may be particularly important in managing symptoms and long-term prognosis of PAD patients.

Journal of vascular surgery · cohort or longitudinal · 40 citationsread the source →

Smartphone Apps for Smoking Cessation: Systematic Framework for App Review and Analysis.

Background: Cigarette smoking is a leading cause of preventable death, and identifying novel treatment approaches to promote smoking cessation is critical for improving public health. With the rise of digital health and mobile apps, these tools offer potential opportunities to address smoking cessation, yet the functionality of these apps and whether they offer scientifically based support for smoking cessation are unknown. Objective: The goal of this research was to use the American Psychiatric Association app evaluation model to evaluate the top-returned apps from Android and Apple app store platforms related to smoking cessation and investigate the common app features available for end users. Methods: We conducted a search of both Android and iOS app stores in July 2021 for apps related to the keywords "smoking," "tobacco," "smoke," and "cigarette" to evaluate apps for smoking cessation. Apps were screened for relevance, and trained raters identified and analyzed features, including accessibility (ie, cost), privacy, clinical foundation, and features of the apps, using a systematic framework of 105 objective questions from the American Psychiatric Association app evaluation model. All app rating data were deposited in mindapps, a publicly accessible database that is continuously updated every 6 months given the dynamic nature of apps available in the marketplace. We characterized apps available in July 2021 and November 2022. Results: We initially identified 389 apps, excluded 161 due to irrelevance and nonfunctioning, and rated 228, including 152 available for Android platforms and 120 available for iOS platforms. Some of the top-returned apps (71/228, 31%) in 2021 were no longer functioning in 2022. Our analysis of rated apps revealed limitations in accessibility and features. While most apps (179/228, 78%) were free to download, over half had costs associated with in-app purchases or full use. Less than 65% (149/228) had a privacy policy addressing the data collected in the app. In terms of intervention features, more than 56% (128/228) of apps allowed the user to set and check in on goals, and more than 46% (106/228) of them provided psychoeducation, although few apps provided evidence-based support for smoking cessation, such as peer support or skill training, including mindfulness and deep breathing, and even fewer provided evidence-based interventions, such as acceptance and commitment therapy or cognitive behavioral therapy. Only 12 apps in 2021 and 11 in 2022 had published studies supporting the feasibility or efficacy for smoking cessation. Conclusions: Numerous smoking cessation apps were identified, but analysis revealed limitations, including high rates of irrelevant and nonfunctioning apps, high rates of turnover, and few apps providing evidence-based support for smoking cessation. Thus, it may be challenging for consumers to identify relevant, evidence-based apps to support smoking cessation in the app store, and a comprehensive evaluation system of mental health apps is critically important.

Journal of medical Internet research · review · 25 citationsread the source →

Is knowledge "half the battle"? The role of depression literacy in help-seeking among a non-clinical sample of adults with currently untreated mental health problems.

Backgrounds: The concept of mental health literacy suggests that higher literacy increases the likelihood of seeking treatment. However, previous studies mostly use vignettes, and do not investigate actual help-seeking behaviour. Methods: We assessed depression literacy and type of mental illness in a convenience sample of 207 adults with currently untreated mental health problems from the general population. Our analysis sample comprised 152 adults (Mage = 52.12; 73.0% female) with a depressive disorder. Help-seeking behaviour was measured 3 and 6 months after the initial assessment. We conducted multiple logistic regression models to test whether depression literacy predicted help-seeking from mental health professionals, general practitioner, family and friends, or counselling, controlling for sociodemographic data, and depression severity. Results: Depression literacy was lower in men and older participants, and higher in participants with prior treatment experience. Depression literacy was negatively linked to informal help-seeking (aOR = 0.33 [0.13; 0.84]) when included as a dichotomous predictor (i.e., 'high' versus 'low' literacy). Limitations: Our sample was small, thus we did not differentiate between types of depressive disorders in our analysis. Conclusion: We could not corroborate most postulated associations between depression literacy and help-seeking, except for the negative association with informal help. Our findings underline differences between previous vignette-based and community-based investigations of the help-seeking process for mental health problems. To explore underlying mechanisms, future research should investigate the role of intermediary variables and processes in the association between depression literacy and help-seeking, such as self-efficacy and symptom attribution, which might be more clinically relevant in help-seeking for depressive symptoms.

Journal of affective disorders · 27 citationsread the source →

Association Between Screen Time Trajectory and Early Childhood Development in Children in China.

Importance: Screen time has become an integral part of children's daily lives. Nevertheless, the developmental consequences of screen exposure in young children remain unclear. Objective: To investigate the screen time trajectory from 6 to 72 months of age and its association with children's development at age 72 months in a prospective birth cohort. Design, setting, and participants: Women in Shanghai, China, who were at 34 to 36 gestational weeks and had an expected delivery date between May 2012 and July 2013 were recruited for this cohort study. Their children were followed up at 6, 9, 12, 18, 24, 36, 48, and 72 months of age. Children's screen time was classified into 3 groups at age 6 months: continued low (ie, stable amount of screen time), late increasing (ie, sharp increase in screen time at age 36 months), and early increasing (ie, large amount of screen time in early stages that remained stable after age 36 months). Cognitive development was assessed by specially trained research staff in a research clinic. Of 262 eligible mother-offspring pairs, 152 dyads had complete data regarding all variables of interest and were included in the analyses. Data were analyzed from September 2019 to November 2021. Exposures: Mothers reported screen times of children at 6, 9, 12, 18, 24, 36, 48, and 72 months of age. Main outcomes and measures: The cognitive development of children was evaluated using the Wechsler Intelligence Scale for Children, 4th edition, at age 72 months. Social-emotional development was measured by the Strengths and Difficulties Questionnaire, which was completed by the child's mother. The study described demographic characteristics, maternal mental health, child's temperament at age 6 months, and mental development at age 12 months by subgroups clustered by a group-based trajectory model. Group difference was examined by analysis of variance. Results: A total of 152 mother-offspring dyads were included in this study, including 77 girls (50.7%) and 75 boys (49.3%) (mean [SD] age of the mothers was 29.7 [3.3] years). Children's screen time trajectory from age 6 to 72 months was classified into 3 groups: continued low (110 [72.4%]), late increasing (17 [11.2%]), and early increasing (25 [16.4%]). Compared with the continued low group, the late increasing group had lower scores on the Full-Scale Intelligence Quotient (β coefficient, -8.23; 95% CI, -15.16 to -1.30; P < .05) and the General Ability Index (β coefficient, -6.42; 95% CI, -13.70 to 0.86; P = .08); the early increasing group presented with lower scores on the Full-Scale Intelligence Quotient (β coefficient, -6.68; 95% CI, -12.35 to -1.02; P < .05) and the Cognitive Proficiency Index (β coefficient, -10.56; 95% CI, -17.23 to -3.90; P < .01) and a higher total difficulties score (β coefficient, 2.62; 95% CI, 0.49-4.76; P < .05). Conclusions and relevance: This cohort study found that excessive screen time in early years was associated with poor cognitive and social-emotional development. This finding may be helpful in encouraging awareness among parents of the importance of onset and duration of children's screen time.

JAMA pediatrics · 59 citationsread the source →

Empowering With PrEP (E-PrEP), a Peer-Led Social Media-Based Intervention to Facilitate HIV Preexposure Prophylaxis Adoption Among Young Black and Latinx Gay and Bisexual Men: Protocol for a Cluster Randomized Controlled Trial.

Background: Young black and Latinx, gay, bisexual, and other men who have sex with men (YBLGBM, aged 18-29 years) have among the highest rates of new HIV infections in the United States and are not consistently reached by existing prevention interventions. Preexposure prophylaxis (PrEP), an oral antiretroviral regimen taken daily by HIV-uninfected individuals to prevent HIV acquisition, is highly efficacious in reducing HIV acquisition and could help stop the HIV epidemic in YBLGBM. Use of social media (eg, Facebook, Twitter, online dating sites) is ubiquitous among young people, providing an efficient avenue to engage YBLGBM to facilitate PrEP adoption. Objective: Our overall goal was to develop and pilot test a theoretically grounded, social media-based, peer-led intervention to increase PrEP uptake in YBLGBM. We used diffusion of innovation and information-motivation-behavioral skills frameworks to (1) identify potential factors associated with interest in and adoption of PrEP among YBLGBM; (2) develop Empowering with PrEP (E-PrEP), a social media-based, peer-led intervention to increase PrEP uptake in YBLGBM; and (3) pilot test the feasibility and acceptability of E-PrEP, and determine its preliminary efficacy for increasing adoption of PrEP by YBLGBM. We describe the development and protocol for E-PrEP. Methods: Using a participatory research approach, we partnered with YBLGBM intervention development partners to develop a social media-based behavioral intervention to facilitate PrEP uptake, which involved an online messaging campaign disseminated by YBLGBM peer leaders to their existing online networks. We designed the 6-week campaign to provide education about PrEP, increase motivation to use PrEP, and facilitate access to PrEP. We then conducted a cluster-randomized trial of E-PrEP compared with an attention-matched general health control condition (E-Health) among YBLGBM aged 18 to 29 years to assess E-PrEP's feasibility, acceptability, preliminary efficacy for increasing self-reported intention to use PrEP, PrEP uptake, and impact on knowledge and attitudes about PrEP at 12-week follow-up (6 weeks after the end of the online campaign). Results: From October 2016 to March 2017, we developed, pretested, and refined E-PrEP with 6 YBLGBM intervention development partners. From May to June 2017, we recruited, enrolled, and randomly assigned 10 peer leaders (n=5 for each condition). The 10 peer leaders then recruited and enrolled 152 participants from their existing online networks (range 3-33 per peer leader), during June and July 2017. Intervention follow-up was completed after 12 weeks, in November 2017, with analyses underway. Conclusions: We hypothesize that, compared with E-Health, participants randomly assigned to E-PrEP will be more likely to express intention to use PrEP and greater PrEP uptake, and will also show changes in potential mediators of PrEP uptake (knowledge, attitudes, stigma, and access). A Web-based biobehavioral intervention model such as E-PrEP could be rapidly scaled even with limited resources and have significant population-level impact. Trial registration: ClinicalTrials.gov NCT03213366; https://clinicaltrials.gov/ct2/show/NCT03213366 (Archived by WebCite at http://www.webcitation.org/71onSdcXY). Registered report identifier: RR1-10.2196/11375.

JMIR research protocols · 74 citationsread the source →

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

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

The lancet. Psychiatry · 211 citationsread the source →

Association of tiered restrictions and a second lockdown with COVID-19 deaths and hospital admissions in England: a modelling study.

Background: A second wave of COVID-19 cases in autumn, 2020, in England led to localised, tiered restrictions (so-called alert levels) and, subsequently, a second national lockdown. We examined the impact of these tiered restrictions, and alternatives for lockdown stringency, timing, and duration, on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission and hospital admissions and deaths from COVID-19. Methods: We fit an age-structured mathematical model of SARS-CoV-2 transmission to data on hospital admissions and hospital bed occupancy (ISARIC4C/COVID-19 Clinical Information Network, National Health Service [NHS] England), seroprevalence (Office for National Statistics, UK Biobank, REACT-2 study), virology (REACT-1 study), and deaths (Public Health England) across the seven NHS England regions from March 1, to Oct 13, 2020. We analysed mobility (Google Community Mobility) and social contact (CoMix study) data to estimate the effect of tiered restrictions implemented in England, and of lockdowns implemented in Northern Ireland and Wales, in October, 2020, and projected epidemiological scenarios for England up to March 31, 2021. Findings: We estimated a reduction in the effective reproduction number (Rt) of 2% (95% credible interval [CrI] 0-4) for tier 2, 10% (6-14) for tier 3, 35% (30-41) for a Northern Ireland-stringency lockdown with schools closed, and 44% (37-49) for a Wales-stringency lockdown with schools closed. From Oct 1, 2020, to March 31, 2021, a projected COVID-19 epidemic without tiered restrictions or lockdown results in 280 000 (95% projection interval 274 000-287 000) hospital admissions and 58 500 (55 800-61 100) deaths. Tiered restrictions would reduce hospital admissions to 238 000 (231 000-245 000) and deaths to 48 600 (46 400-50 700). From Nov 5, 2020, a 4-week Wales-type lockdown with schools remaining open-similar to the lockdown measures announced in England in November, 2020-was projected to further reduce hospital admissions to 186 000 (179 000-193 000) and deaths to 36 800 (34 900-38 800). Closing schools was projected to further reduce hospital admissions to 157 000 (152 000-163 000) and deaths to 30 300 (29 000-31 900). A projected lockdown of greater than 4 weeks would reduce deaths but would bring diminishing returns in reducing peak pressure on hospital services. An earlier lockdown would have reduced deaths and hospitalisations in the short term, but would lead to a faster resurgence in cases after January, 2021. In a post-hoc analysis, we estimated that the second lockdown in England (Nov 5-Dec 2) reduced Rt by 22% (95% CrI 15-29), rather than the 32% (25-39) reduction estimated for a Wales-stringency lockdown with schools open. Interpretation: Lockdown measures outperform less stringent restrictions in reducing cumulative deaths. We projected that the lockdown policy announced to commence in England on Nov 5, with a similar stringency to the lockdown adopted in Wales, would reduce pressure on the health service and would be well timed to suppress deaths over the winter period, while allowing schools to remain open. Following completion of the analysis, we analysed new data from November, 2020, and found that despite similarities in policy, the second lockdown in England had a smaller impact on behaviour than did the second lockdown in Wales, resulting in more deaths and hospitalisations than we originally projected when focusing on a Wales-stringency scenario for the lockdown. Funding: Horizon 2020, UK Medical Research Council, and the National Institute for Health Research.

The Lancet. Infectious diseases · 109 citationsread the source →

A Multi-Domain Self-Report Measure of Coparenting.

OBJECTIVE: This study reports the psychometric properties of a multi-domain measure of the coparenting relationship in dual-parent families. METHOD: 152 couples participating in a transition to parenthood study completed the Coparenting Relationship Scale and additional measures during home visits at child age 6 months, 1 year, and 3 years. RESULTS: Psychometric and construct validity assessments indicated the measure performed satisfactorily. The 35-item measure demonstrated good reliability and strong stability. Subscales measuring theoretically and empirically important aspects of coparenting (coparenting agreement, coparenting closeness, exposure of child to conflict, coparenting support, coparenting undermining, endorsement of partner's parenting, and division of labor) demonstrated good reliability as well. A 14-item brief overall measure showed very strong associations with the overall measure. Relations of the full scale with a measure of social desirability were weak, and the full scale was positively associated with positive dimensions of the dyadic couple relationship (love, sex/romance, couple efficacy) and inversely associated with negative dimensions (conflict, ineffective arguing)-as expected. CONCLUSIONS: This initial examination of the Coparenting Relationship Scale suggests that it possesses good psychometric properties (reliability, stability, construct validity, and inter-rater agreement), can be flexibly administered in short and long forms, and is positioned to promote further conceptual and methodological progress in the study of coparenting.

Parenting, science and practice · 214 citationsread the source →