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Automated telephone communication systems for preventive healthcare and management of long-term conditions.

Background: Automated telephone communication systems (ATCS) can deliver voice messages and collect health-related information from patients using either their telephone's touch-tone keypad or voice recognition software. ATCS can supplement or replace telephone contact between health professionals and patients. There are four different types of ATCS: unidirectional (one-way, non-interactive voice communication), interactive voice response (IVR) systems, ATCS with additional functions such as access to an expert to request advice (ATCS Plus) and multimodal ATCS, where the calls are delivered as part of a multicomponent intervention. Objectives: To assess the effects of ATCS for preventing disease and managing long-term conditions on behavioural change, clinical, process, cognitive, patient-centred and adverse outcomes. Search methods: We searched 10 electronic databases (the Cochrane Central Register of Controlled Trials; MEDLINE; Embase; PsycINFO; CINAHL; Global Health; WHOLIS; LILACS; Web of Science; and ASSIA); three grey literature sources (Dissertation Abstracts, Index to Theses, Australasian Digital Theses); and two trial registries (www.controlled-trials.com; www.clinicaltrials.gov) for papers published between 1980 and June 2015. Selection criteria: Randomised, cluster- and quasi-randomised trials, interrupted time series and controlled before-and-after studies comparing ATCS interventions, with any control or another ATCS type were eligible for inclusion. Studies in all settings, for all consumers/carers, in any preventive healthcare or long term condition management role were eligible. Data collection and analysis: We used standard Cochrane methods to select and extract data and to appraise eligible studies. Main results: We included 132 trials (N = 4,669,689). Studies spanned across several clinical areas, assessing many comparisons based on evaluation of different ATCS types and variable comparison groups. Forty-one studies evaluated ATCS for delivering preventive healthcare, 84 for managing long-term conditions, and seven studies for appointment reminders. We downgraded our certainty in the evidence primarily because of the risk of bias for many outcomes. We judged the risk of bias arising from allocation processes to be low for just over half the studies and unclear for the remainder. We considered most studies to be at unclear risk of performance or detection bias due to blinding, while only 16% of studies were at low risk. We generally judged the risk of bias due to missing data and selective outcome reporting to be unclear. For preventive healthcare, ATCS (ATCS Plus, IVR, unidirectional) probably increase immunisation uptake in children (risk ratio (RR) 1.25, 95% confidence interval (CI) 1.18 to 1.32; 5 studies, N = 10,454; moderate certainty) and to a lesser extent in adolescents (RR 1.06, 95% CI 1.02 to 1.11; 2 studies, N = 5725; moderate certainty). The effects of ATCS in adults are unclear (RR 2.18, 95% CI 0.53 to 9.02; 2 studies, N = 1743; very low certainty).For screening, multimodal ATCS increase uptake of screening for breast cancer (RR 2.17, 95% CI 1.55 to 3.04; 2 studies, N = 462; high certainty) and colorectal cancer (CRC) (RR 2.19, 95% CI 1.88 to 2.55; 3 studies, N = 1013; high certainty) versus usual care. It may also increase osteoporosis screening. ATCS Plus interventions probably slightly increase cervical cancer screening (moderate certainty), but effects on osteoporosis screening are uncertain. IVR systems probably increase CRC screening at 6 months (RR 1.36, 95% CI 1.25 to 1.48; 2 studies, N = 16,915; moderate certainty) but not at 9 to 12 months, with probably little or no effect of IVR (RR 1.05, 95% CI 0.99, 1.11; 2 studies, 2599 participants; moderate certainty) or unidirectional ATCS on breast cancer screening. Appointment reminders delivered through IVR or unidirectional ATCS may improve attendance rates compared with no calls (low certainty). For long-term management, medication or laboratory test adherence provided the most general evidence across conditions (25 studies, data not combined). Multimodal ATCS versus usual care showed conflicting effects (positive and uncertain) on medication adherence. ATCS Plus probably slightly (versus control; moderate certainty) or probably (versus usual care; moderate certainty) improves medication adherence but may have little effect on adherence to tests (versus control). IVR probably slightly improves medication adherence versus control (moderate certainty). Compared with usual care, IVR probably improves test adherence and slightly increases medication adherence up to six months but has little or no effect at longer time points (moderate certainty). Unidirectional ATCS, compared with control, may have little effect or slightly improve medication adherence (low certainty). The evidence suggested little or no consistent effect of any ATCS type on clinical outcomes (blood pressure control, blood lipids, asthma control, therapeutic coverage) related to adherence, but only a small number of studies contributed clinical outcome data. The above results focus on areas with the most general findings across conditions. In condition-specific areas, the effects of ATCS varied, including by the type of ATCS intervention in use. Multimodal ATCS probably decrease both cancer pain and chronic pain as well as depression (moderate certainty), but other ATCS types were less effective. Depending on the type of intervention, ATCS may have small effects on outcomes for physical activity, weight management, alcohol consumption, and diabetes mellitus. ATCS have little or no effect on outcomes related to heart failure, hypertension, mental health or smoking cessation, and there is insufficient evidence to determine their effects for preventing alcohol/substance misuse or managing illicit drug addiction, asthma, chronic obstructive pulmonary disease, HIV/AIDS, hypercholesterolaemia, obstructive sleep apnoea, spinal cord dysfunction or psychological stress in carers. Only four trials (3%) reported adverse events, and it was unclear whether these were related to the interventions. Authors' conclusions: ATCS interventions can change patients' health behaviours, improve clinical outcomes and increase healthcare uptake with positive effects in several important areas including immunisation, screening, appointment attendance, and adherence to medications or tests. The decision to integrate ATCS interventions in routine healthcare delivery should reflect variations in the certainty of the evidence available and the size of effects across different conditions, together with the varied nature of ATCS interventions assessed. Future research should investigate both the content of ATCS interventions and the mode of delivery; users' experiences, particularly with regard to acceptability; and clarify which ATCS types are most effective and cost-effective.

The Cochrane database of systematic reviews · meta-analysis · 86 citationsread the source →

Interventions to prevent obesity in children aged 5 to 11 years old.

Background: Prevention of obesity in children is an international public health priority given the prevalence of the condition (and its significant impact on health, development and well-being). Interventions that aim to prevent obesity involve behavioural change strategies that promote healthy eating or 'activity' levels (physical activity, sedentary behaviour and/or sleep) or both, and work by reducing energy intake and/or increasing energy expenditure, respectively. There is uncertainty over which approaches are more effective and numerous new studies have been published over the last five years, since the previous version of this Cochrane review. Objectives: To assess the effects of interventions that aim to prevent obesity in children by modifying dietary intake or 'activity' levels, or a combination of both, on changes in BMI, zBMI score and serious adverse events. Search methods: We used standard, extensive Cochrane search methods. The latest search date was February 2023. Selection criteria: Randomised controlled trials in children (mean age 5 years and above but less than 12 years), comparing diet or 'activity' interventions (or both) to prevent obesity with no intervention, usual care, or with another eligible intervention, in any setting. Studies had to measure outcomes at a minimum of 12 weeks post baseline. We excluded interventions designed primarily to improve sporting performance. Data collection and analysis: We used standard Cochrane methods. Our outcomes were body mass index (BMI), zBMI score and serious adverse events, assessed at short- (12 weeks to < 9 months from baseline), medium- (9 months to < 15 months) and long-term (≥ 15 months) follow-up. We used GRADE to assess the certainty of the evidence for each outcome. Main results: This review includes 172 studies (189,707 participants); 149 studies (160,267 participants) were included in meta-analyses. One hundred forty-six studies were based in high-income countries. The main setting for intervention delivery was schools (111 studies), followed by the community (15 studies), the home (eight studies) and a clinical setting (seven studies); one intervention was conducted by telehealth and 31 studies were conducted in more than one setting. Eighty-six interventions were implemented for less than nine months; the shortest was conducted over one visit and the longest over four years. Non-industry funding was declared by 132 studies; 24 studies were funded in part or wholly by industry. Dietary interventions versus control Dietary interventions, compared with control, may have little to no effect on BMI at short-term follow-up (mean difference (MD) 0, 95% confidence interval (CI) -0.10 to 0.10; 5 studies, 2107 participants; low-certainty evidence) and at medium-term follow-up (MD -0.01, 95% CI -0.15 to 0.12; 9 studies, 6815 participants; low-certainty evidence) or zBMI at long-term follow-up (MD -0.05, 95% CI -0.10 to 0.01; 7 studies, 5285 participants; low-certainty evidence). Dietary interventions, compared with control, probably have little to no effect on BMI at long-term follow-up (MD -0.17, 95% CI -0.48 to 0.13; 2 studies, 945 participants; moderate-certainty evidence) and zBMI at short- or medium-term follow-up (MD -0.06, 95% CI -0.13 to 0.01; 8 studies, 3695 participants; MD -0.04, 95% CI -0.10 to 0.02; 9 studies, 7048 participants; moderate-certainty evidence). Five studies (1913 participants; very low-certainty evidence) reported data on serious adverse events: one reported serious adverse events (e.g. allergy, behavioural problems and abdominal discomfort) that may have occurred as a result of the intervention; four reported no effect. Activity interventions versus control Activity interventions, compared with control, may have little to no effect on BMI and zBMI at short-term or long-term follow-up (BMI short-term: MD -0.02, 95% CI -0.17 to 0.13; 14 studies, 4069 participants; zBMI short-term: MD -0.02, 95% CI -0.07 to 0.02; 6 studies, 3580 participants; low-certainty evidence; BMI long-term: MD -0.07, 95% CI -0.24 to 0.10; 8 studies, 8302 participants; zBMI long-term: MD -0.02, 95% CI -0.09 to 0.04; 6 studies, 6940 participants; low-certainty evidence). Activity interventions likely result in a slight reduction of BMI and zBMI at medium-term follow-up (BMI: MD -0.11, 95% CI -0.18 to -0.05; 16 studies, 21,286 participants; zBMI: MD -0.05, 95% CI -0.09 to -0.02; 13 studies, 20,600 participants; moderate-certainty evidence). Eleven studies (21,278 participants; low-certainty evidence) reported data on serious adverse events; one study reported two minor ankle sprains and one study reported the incident rate of adverse events (e.g. musculoskeletal injuries) that may have occurred as a result of the intervention; nine studies reported no effect. Dietary and activity interventions versus control Dietary and activity interventions, compared with control, may result in a slight reduction in BMI and zBMI at short-term follow-up (BMI: MD -0.11, 95% CI -0.21 to -0.01; 27 studies, 16,066 participants; zBMI: MD -0.03, 95% CI -0.06 to 0.00; 26 studies, 12,784 participants; low-certainty evidence) and likely result in a reduction of BMI and zBMI at medium-term follow-up (BMI: MD -0.11, 95% CI -0.21 to 0.00; 21 studies, 17,547 participants; zBMI: MD -0.05, 95% CI -0.07 to -0.02; 24 studies, 20,998 participants; moderate-certainty evidence). Dietary and activity interventions compared with control may result in little to no difference in BMI and zBMI at long-term follow-up (BMI: MD 0.03, 95% CI -0.11 to 0.16; 16 studies, 22,098 participants; zBMI: MD -0.02, 95% CI -0.06 to 0.01; 22 studies, 23,594 participants; low-certainty evidence). Nineteen studies (27,882 participants; low-certainty evidence) reported data on serious adverse events: four studies reported occurrence of serious adverse events (e.g. injuries, low levels of extreme dieting behaviour); 15 studies reported no effect. Heterogeneity was apparent in the results for all outcomes at the three follow-up times, which could not be explained by the main setting of the interventions (school, home, school and home, other), country income status (high-income versus non-high-income), participants' socioeconomic status (low versus mixed) and duration of the intervention. Most studies excluded children with a mental or physical disability. Authors' conclusions: The body of evidence in this review demonstrates that a range of school-based 'activity' interventions, alone or in combination with dietary interventions, may have a modest beneficial effect on obesity in childhood at short- and medium-term, but not at long-term follow-up. Dietary interventions alone may result in little to no difference. Limited evidence of low quality was identified on the effect of dietary and/or activity interventions on severe adverse events and health inequalities; exploratory analyses of these data suggest no meaningful impact. We identified a dearth of evidence for home and community-based settings (e.g. delivered through local youth groups), for children living with disabilities and indicators of health inequities.

The Cochrane database of systematic reviews · meta-analysis · 40 citationsread the source →

Neurostimulation of the cholinergic anti-inflammatory pathway ameliorates disease in rat collagen-induced arthritis.

Introduction: The inflammatory reflex is a physiological mechanism through which the nervous system maintains immunologic homeostasis by modulating innate and adaptive immunity. We postulated that the reflex might be harnessed therapeutically to reduce pathological levels of inflammation in rheumatoid arthritis by activating its prototypical efferent arm, termed the cholinergic anti-inflammatory pathway. To explore this, we determined whether electrical neurostimulation of the cholinergic anti-inflammatory pathway reduced disease severity in the collagen-induced arthritis model. Methods: Rats implanted with vagus nerve cuff electrodes had collagen-induced arthritis induced and were followed for 15 days. Animals underwent active or sham electrical stimulation once daily from day 9 through the conclusion of the study. Joint swelling, histology, and levels of cytokines and bone metabolism mediators were assessed. Results: Compared with sham treatment, active neurostimulation of the cholinergic anti-inflammatory pathway resulted in a 52% reduction in ankle diameter (p = 0.02), a 57% reduction in ankle diameter (area under curve; p = 0.02) and 46% reduction overall histological arthritis score (p = 0.01) with significant improvements in inflammation, pannus formation, cartilage destruction, and bone erosion (p = 0.02), accompanied by numerical reductions in systemic cytokine levels, not reaching statistical significance. Bone erosion improvement was associated with a decrease in serum levels of receptor activator of NF-κB ligand (RANKL) from 132±13 to 6±2 pg/mL (mean±SEM, p = 0.01). Conclusions: The severity of collagen-induced arthritis is reduced by neurostimulation of the cholinergic anti-inflammatory pathway delivered using an implanted electrical vagus nerve stimulation cuff electrode, and supports the rationale for testing this approach in human inflammatory disorders.

PloS one · 142 citationsread the source →

Underlying mechanisms and efficacy of a suicide-focused psychological intervention for psychosis, the Cognitive Approaches to Combatting Suicidality (CARMS): a multicentre, assessor-masked, randomised controlled trial in the UK.

Background: There is a need for theoretically grounded and testable suicide-focused psychological therapies, especially in people with severe mental health problems, specifically non-affective psychosis. We aimed to test both the underlying mechanisms and efficacy of a suicide-focused therapy, cognitive behavioural suicide prevention for psychosis (CBSPp). Methods: We did a multicentre, assessor-masked, randomised controlled trial conducted at four UK National Health Service (NHS) sites. Participants were eligible for enrolment if they were 18 years or older; met ICD-10 criteria for non-affective psychosis (F20-F29); had self-reported suicidal experiences in the 3 months before recruitment; were under the care of an NHS mental health services team; were not receiving a psychological therapy as part of a similar trial; had sufficient competency in the English language not to need an interpreter to participate; and were able to give informed consent. After screening for eligibility and completion of baseline assessments, participants were randomly allocated in a 1:1 ratio to either the treatment as usual group (control) or CBSPp therapy plus standard treatment group (treatment), with stratification by use of antidepressant medication and NHS site. Randomisation took place using an online Sealed Envelope randomisation procedure conducted and overseen by the Manchester Academic Health Sciences Centre Clinical Trials Unit (MCTU). This system was accessed only by specially allocated staff (eg, the CARMS Trial Manager or the MCTU Trial manager). When the system randomly allocated a participant, an unmasked email confirmation was sent to the unmasked coprincipal investigator and the CARMS Trial Manager (also unmasked). Assessors, the trial statistician, and one coprincipal investigator were masked to allocation group. Participants were informed of their randomised allocation group by an unmasked CARMS staff member. Experts-by-experience were involved in all stages of the research. For those in the treatment group, approximately 24 one-to-one therapy sessions were offered, usually weekly, for around 50 min per session. Assessments were conducted at baseline, month 6, and month 12. The primary outcome was suicide ideation severity measured by the 25-item Adult Suicide Ideation Questionnaire (ASIQ), assessed at month 6 relative to baseline. Outcome analyses used mixed models in the intention-to-treat population. Planned mediation indirect linear regression models examined appraisals of poor social support, emotional difficulties, interpersonal problem-solving difficulties, defeat, entrapment, and hopelessness as mediators at 6 months with allocation condition (treatment vs control) as the predictor variable and suicidal ideation severity (ASIQ) at 6 months as the outcome variable, whilst controlling for baseline levels of the mediator and outcome variables. The trial was registered before recruitment at ClinicalTrials.gov (NCT03114917) and ISRCTN (ISRCTN17776666) and is complete. Findings: We recruited participants from four NHS sites from June 21, 2017, to Nov 25, 2020, with the final 12-month assessment completed on Jan 10, 2022. 479 participants were screened for eligibility, and of these 329 (69%) provided consent and were enrolled. After 69 participants were lost to follow-up, 292 participants were randomly allocated to the treatment and control groups (149 [51%] and 143 [49%], respectively). At baseline, 161 (55%) participants were male and 130 (45%) were female; one participant (<1%) in the treatment group was missing gender data. Mean age was 35·1 years (SD 13·2; range 18-69), and 247 (85%) were White or Caucasian. Severity of suicidal ideation was not statistically different between the treatment (n=136) and the control groups (n=116) at 6 months (p=0·07; Cohen's d -0·20 [95% CI -0·42 to 0·02]). A significant indirect mediation effect (-2·85, -7·00 to -0·23) showed that therapy strengthened social support appraisals which, in turn, reduced suicidal ideation severity at 6 months more in the treatment group than in the control group. Suicide attempts were the most frequent severe adverse event (132 attempts in 26 participants in the treatment group vs 91 attempts in 30 participants in the control group). There were four deaths in the CARMS study, none of which were by suicide or considered related to treatment. Interpretation: CBSPp had no effect on suicidal ideation at 6 months, but it did have a significant indirect effect via improving appraisals of social support. It is important to explore how suicide-focused therapies can be developed and implemented in mental health services so that they maximally enhance appraisals of social support and social connection in ways that endure. Funding: Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health and Care Research partnership (reference number: 13/161/25).

The lancet. Psychiatry · randomised controlled trial · 4 citationsread the source →

Remdesivir plus standard of care versus standard of care alone for the treatment of patients admitted to hospital with COVID-19 (DisCoVeRy): a phase 3, randomised, controlled, open-label trial.

Background: The antiviral efficacy of remdesivir against SARS-CoV-2 is still controversial. We aimed to evaluate the clinical efficacy of remdesivir plus standard of care compared with standard of care alone in patients admitted to hospital with COVID-19, with indication of oxygen or ventilator support. Methods: DisCoVeRy was a phase 3, open-label, adaptive, multicentre, randomised, controlled trial conducted in 48 sites in Europe (France, Belgium, Austria, Portugal, Luxembourg). Adult patients (aged ≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection and illness of any duration were eligible if they had clinical evidence of hypoxaemic pneumonia, or required oxygen supplementation. Exclusion criteria included elevated liver enzymes, severe chronic kidney disease, any contraindication to one of the studied treatments or their use in the 29 days before random assignment, or use of ribavirin, as well as pregnancy or breastfeeding. Participants were randomly assigned (1:1:1:1:1) to receive standard of care alone or in combination with remdesivir, lopinavir-ritonavir, lopinavir-ritonavir and interferon beta-1a, or hydroxychloroquine. Randomisation used computer-generated blocks of various sizes; it was stratified on severity of disease at inclusion and on European administrative region. Remdesivir was administered as 200 mg intravenous infusion on day 1, followed by once daily, 1-h infusions of 100 mg up to 9 days, for a total duration of 10 days. It could be stopped after 5 days if the participant was discharged. The primary outcome was the clinical status at day 15 measured by the WHO seven-point ordinal scale, assessed in the intention-to-treat population. Safety was assessed in the modified intention-to-treat population and was one of the secondary outcomes. This trial is registered with the European Clinical Trials Database, EudraCT2020-000936-23, and ClinicalTrials.gov, NCT04315948. Findings: Between March 22, 2020, and Jan 21, 2021, 857 participants were enrolled and randomly assigned to remdesivir plus standard of care (n=429) or standard of care only (n=428). 15 participants were excluded from analysis in the remdesivir group, and ten in the control group. At day 15, the distribution of the WHO ordinal scale was: (1) not hospitalised, no limitations on activities (61 [15%] of 414 in the remdesivir group vs 73 [17%] of 418 in the control group); (2) not hospitalised, limitation on activities (129 [31%] vs 132 [32%]); (3) hospitalised, not requiring supplemental oxygen (50 [12%] vs 29 [7%]); (4) hospitalised, requiring supplemental oxygen (76 [18%] vs 67 [16%]); (5) hospitalised, on non-invasive ventilation or high flow oxygen devices (15 [4%] vs 14 [3%]); (6) hospitalised, on invasive mechanical ventilation or extracorporeal membrane oxygenation (62 [15%] vs 79 [19%]); (7) death (21 [5%] vs 24 [6%]). The difference between treatment groups was not significant (odds ratio 0·98 [95% CI 0·77-1·25]; p=0·85). There was no significant difference in the occurrence of serious adverse events between treatment groups (remdesivir, 135 [33%] of 406 vs control, 130 [31%] of 418; p=0·48). Three deaths (acute respiratory distress syndrome, bacterial infection, and hepatorenal syndrome) were considered related to remdesivir by the investigators, but only one by the sponsor's safety team (hepatorenal syndrome). Interpretation: No clinical benefit was observed from the use of remdesivir in patients who were admitted to hospital for COVID-19, were symptomatic for more than 7 days, and required oxygen support. Funding: European Union Commission, French Ministry of Health, Domaine d'intérêt majeur One Health Île-de-France, REACTing, Fonds Erasme-COVID-Université Libre de Bruxelles, Belgian Health Care Knowledge Centre, Austrian Group Medical Tumor, European Regional Development Fund, Portugal Ministry of Health, Portugal Agency for Clinical Research and Biomedical Innovation. Translation: For the French translation of the abstract see Supplementary Materials section.

The Lancet. Infectious diseases · randomised controlled trial · 264 citationsread the source →

Vagus Nerve Stimulation for the Treatment of Heart Failure: The INOVATE-HF Trial.

Background: Heart failure (HF) is increasing in prevalence and is a major cause of morbidity and mortality despite advances in medical and device therapy. Autonomic imbalance, with excess sympathetic activation and decreased vagal tone, is an integral component of the pathophysiology of HF. Objectives: The INOVATE-HF (Increase of Vagal Tone in Heart Failure) trial assessed the safety and efficacy of vagal nerve stimulation (VNS) among patients with HF and a reduced ejection fraction. Methods: INOVATE-HF was a multinational, randomized trial involving 85 centers including patients with chronic HF, New York Heart Association functional class III symptoms and ejection fraction ≤40%. Patients were assigned to device implantation to provide VNS (active) or continued medical therapy (control) in a 3:2 ratio. The primary efficacy endpoint was composite of death from any cause or first event for worsening HF. Results: Patients (n = 707) were randomized and followed up for a mean of 16 months. The primary efficacy outcome occurred in 132 of 436 patients in the VNS group, compared to 70 of 271 in the control group (30.3% vs. 25.8%; hazard ratio: 1.14; 95% confidence interval: 0.86 to 1.53; p = 0.37). During the trial, the estimated annual mortality rates were 9.3% and 7.1%, respectively (p = 0.19). Quality of life, New York Heart Association functional class, and 6-min walking distance were favorably affected by VNS (p < 0.05), but left ventricular end-systolic volume index was not different (p = 0.49). Conclusions: VNS does not reduce the rate of death or HF events in chronic HF patients. (INcrease Of VAgal TonE in CHF [INOVATE-HF]; NCT01303718).

Journal of the American College of Cardiology · randomised controlled trial · 281 citationsread the source →

Effect of a Health Care Professional Communication Training Intervention on Adolescent Human Papillomavirus Vaccination: A Cluster Randomized Clinical Trial.

Importance: The incidence of human papillomavirus (HPV)-related cancers is more than 35 000 cases in the United States each year. Effective HPV vaccines have been available in the United States for several years but are underused among adolescents, the target population for vaccination. Interventions to increase uptake are needed. Objective: To evaluate the effect of a 5-component health care professional HPV vaccine communication intervention on adolescent HPV vaccination. Design, setting, and participants: A cluster randomized clinical trial using covariate-constrained randomization to assign study arms and an intent-to-treat protocol was conducted in 16 primary care practices in the Denver, Colorado, metropolitan area. Participants included 188 medical professionals and 43 132 adolescents. Interventions: The 5 components of the intervention were an HPV fact sheet library to create customized information sheets relevant to each practice's patient population, a tailored parent education website, a set of HPV-related disease images, an HPV vaccine decision aid, and 2½ hours of communication training on using a presumptive vaccine recommendation, followed by motivational interviewing if parents were resistant to vaccination. Each practice participated in a series of 2 intervention development meetings over a 6-month period (August 1, 2014, to January 31, 2015) before the intervention. Main outcomes and measures: Differences between control and intervention changes over time (ie, difference in differences between the baseline and intervention period cohorts of patients) in HPV vaccine series initiation (≥1 dose) and completion (≥3 doses) among patients aged 11 to 17 years seen at the practices between February 1, 2015, and January 31, 2016. Vaccination data were obtained from the practices' records and augmented with state immunization information system data. Results: Sixteen practices and 43 132 patients (50.3% female; median age, 12.6 years [interquartile range, 10.8-14.7 years] at the beginning of the study period) participated in this trial. Adolescents in the intervention practices had significantly higher odds of HPV vaccine series initiation (adjusted odds ratio [aOR], 1.46; 95% CI, 1.31-1.62) and completion (aOR, 1.56; 95% CI, 1.27-1.92) than those in the control practices (a 9.5-absolute percentage point increase in HPV vaccine series initiation and a 4.4-absolute percentage point increase in HPV vaccine series completion in intervention practices). The intervention had a greater effect in pediatric practices compared with family medicine practices and in private practices compared with public ones. Health care professionals reported that communication training and the fact sheets were the most used and useful intervention components. Conclusions and relevance: A health care professional communication intervention significantly improved HPV vaccine series initiation and completion among adolescent patients. Trial registration: clinicaltrials.gov Identifier: NCT02456077.

JAMA pediatrics · randomised controlled trial · 226 citationsread the source →

Association of behaviour change techniques with effectiveness of dietary interventions among adults of retirement age: a systematic review and meta-analysis of randomised controlled trials.

Background: There is a need for development of more effective interventions to achieve healthy eating, enhance healthy ageing, and to reduce the risk of age-related diseases. The aim of this study was to identify the behaviour change techniques (BCTs) used in complex dietary behaviour change interventions and to explore the association between BCTs utilised and intervention effectiveness. Methods: We undertook a secondary analysis of data from a previous systematic review with meta-analysis of the effectiveness of dietary interventions among people of retirement age. BCTs were identified using the reliable CALO-RE taxonomy in studies reporting fruit and vegetable (F and V) consumption as outcomes. The mean difference in F and V intake between active and control arms was compared between studies in which the BCTs were identified versus those not using the BCTs. Random-effects meta-regression models were used to assess the association of interventions BCTs with F and V intakes. Results: Twenty-eight of the 40 BCTs listed in the CALO-RE taxonomy were identified in the 22 papers reviewed. Studies using the techniques 'barrier identification/problem solving' (93 g, 95% confidence interval (CI) 48 to 137 greater F and V intake), 'plan social support/social change' (78 g, 95%CI 24 to 132 greater F and V intake), 'goal setting (outcome)' (55 g 95%CI 7 to 103 greater F and V intake), 'use of follow-up prompts' (66 g, 95%CI 10 to 123 greater F and V intake) and 'provide feedback on performance' (39 g, 95%CI -2 to 81 greater F and V intake) were associated with greater effects of interventions on F and V consumption compared with studies not using these BCTs. The number of BCTs per study ranged from 2 to 16 (median = 6). Meta-regression showed that one additional BCT led to 8.3 g (95%CI 0.006 to 16.6 g) increase in F and V intake. Conclusions: Overall, this study has identified BCTs associated with effectiveness suggesting that these might be active ingredients of dietary interventions which will be effective in increasing F and V intake in older adults. For interventions targeting those in the peri-retirement age group, 'barrier identification/problem solving' and 'plan for social support/social change' may be particularly useful in increasing the effectiveness of dietary interventions.

BMC medicine · meta-analysis · 78 citationsread the source →

Disorder-specific impact of coordinated anxiety learning and management treatment for anxiety disorders in primary care.

Context: Anxiety disorders commonly present in primary care, where evidence-based mental health treatments often are unavailable or suboptimally delivered. Objective: To compare evidence-based treatment for anxiety disorders with usual care (UC) in primary care for principal and comorbid generalized anxiety disorder (GAD), panic disorder (PD), social anxiety disorder (SAD), and posttraumatic stress disorder (PTSD). Design: A randomized controlled trial comparing the Coordinated Anxiety Learning and Management (CALM) intervention with UC at baseline and at 6-, 12-, and 18-month follow-up assessments. Setting: Seventeen US primary care clinics. Patients: Referred primary care sample, 1004 patients, with principal DSM-IV diagnoses of GAD (n = 549), PD (n = 262), SAD (n = 132), or PTSD (n = 61) (mean [SD] age, 43.7 [13.7] years; 70.9% were female). Eighty percent of the participants completed 18-month follow-up. Interventions: CALM (cognitive behavior therapy and pharmacotherapy recommendations) and UC. Main outcome measures: Generalized Anxiety Disorder Severity Scale, Panic Disorder Severity-Self-report Scale, Social Phobia Inventory, and PTSD Checklist-Civilian Version scores. Results: CALM was superior to UC for principal GAD at 6-month (-1.61; 95% confidence interval [CI], -2.42 to -0.79), 12-month (-2.34; -3.22 to -1.45), and 18-month (-2.37; -3.24 to -1.50), PD at 6-month (-2.00; -3.55 to -0.44) and 12-month (-2.71; -4.29 to -1.14), and SAD at 6-month (-7.05; -12.11 to -2.00) outcomes. CALM was superior to UC for comorbid SAD at 6-month (-4.26; 95% CI, -7.96 to -0.56), 12-month (-8.12, -11.84 to -4.40), and 18- month (-6.23, -9.90 to -2.55) outcomes. Effect sizes favored CALM but were not statistically significant for other comorbid disorders. Conclusions: CALM (cognitive behavior therapy and pharmacotherapy medication recommendations) is more effective than is UC for principal anxiety disorders and, to a lesser extent, comorbid anxiety disorders that present in primary care.

Archives of general psychiatry · randomised controlled trial · 94 citationsread the source →

Telemedicine-Based Collaborative Care for Posttraumatic Stress Disorder

IMPORTANCE: Posttraumatic stress disorder (PTSD) is prevalent, persistent, and disabling. Although psychotherapy and pharmacotherapy have proven efficacious in randomized clinical trials, geographic barriers impede rural veterans from engaging in these evidence-based treatments. OBJECTIVE: To test a telemedicine-based collaborative care model designed to improve engagement in evidence-based treatment of PTSD. DESIGN, SETTING, AND PARTICIPANTS: The Telemedicine Outreach for PTSD (TOP) study used a pragmatic randomized effectiveness trial design with intention-to-treat analyses. Outpatients were recruited from 11 Department of Veterans Affairs (VA) community-based outpatient clinics serving predominantly rural veterans. Inclusion required meeting diagnostic criteria for current PTSD according to the Clinician-Administered PTSD Scale. Exclusion criteria included receiving PTSD treatment at a VA medical center or a current diagnosis of schizophrenia, bipolar disorder, or substance dependence. Two hundred sixty-five veterans were enrolled from November 23, 2009, through September 28, 2011, randomized to usual care (UC) or the TOP intervention, and followed up for 12 months. INTERVENTIONS: Off-site PTSD care teams located at VA medical centers supported on-site community-based outpatient clinic providers. Off-site PTSD care teams included telephone nurse care managers, telephone pharmacists, telepsychologists, and telepsychiatrists. Nurses conducted care management activities. Pharmacists reviewed medication histories. Psychologists delivered cognitive processing therapy via interactive video. Psychiatrists supervised the team and conducted interactive video psychiatric consultations. MAIN OUTCOMES AND MEASURES: The primary outcome was PTSD severity as measured by the Posttraumatic Diagnostic Scale. Process-of-care outcomes included medication prescribing and regimen adherence and initiation of and adherence to cognitive processing therapy. RESULTS: During the 12-month follow-up period, 73 of the 133 patients randomized to TOP (54.9%) received cognitive processing therapy compared with 16 of 132 randomized to UC (12.1%) (odds ratio, 18.08 [95% CI, 7.96-41.06]; P < .001). Patients in the TOP arm had significantly larger decreases in Posttraumatic Diagnostic Scale scores (from 35.0 to 29.1) compared with those in the UC arm (from 33.5 to 32.1) at 6 months (β = -3.81; P = .002). Patients in the TOP arm also had significantly larger decreases in Posttraumatic Diagnostic Scale scores (from 35.0 to 30.1) compared with those in the UC arm (from 33.5 to 31.7) at 12 months (β = -2.49; P=.04). There were no significant group differences in the number of PTSD medications prescribed and adherence to medication regimens were not significant. Attendance at 8 or more sessions of cognitive processing therapy significantly predicted improvement in Posttraumatic Diagnostic Scale scores (β = -3.86 [95% CI, -7.19 to -0.54]; P = .02) and fully mediated the intervention effect at 12 months. CONCLUSIONS AND RELEVANCE: Telemedicine-based collaborative care can successfully engage rural veterans in evidence-based psychotherapy to improve PTSD outcomes. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00821678.

JAMA Psychiatry · randomised controlled trial · 277 citationsread the source →

Cost-effectiveness analysis of a rural telemedicine collaborative care intervention for depression.

Context: Collaborative care interventions for depression in primary care settings are clinically beneficial and cost-effective. Most prior studies were conducted in urban settings. Objective: To examine the cost-effectiveness of a rural telemedicine-based collaborative care depression intervention. Design: Randomized controlled trial of intervention vs usual care. Setting: Seven small (serving 1000 to 5000 veterans) Veterans Health Administration community-based outpatient clinics serving rural catchment areas in 3 mid-South states. Each site had interactive televideo dedicated to mental health but no psychiatrist or psychologist on site. Patients Among 18 306 primary care patients who were screened, 1260 (6.9%) screened positive for depression; 395 met eligibility criteria and were enrolled from April 2003 to September 2004. Of those enrolled, 360 (91.1%) completed a 6-month follow-up and 335 (84.8%) completed a 12-month follow-up. Intervention A stepped-care model for depression treatment was used by an off-site depression care team to make treatment recommendations via electronic medical record. The team included a nurse depression care manager, clinical pharmacist, and psychiatrist. The depression care manager communicated with patients via telephone and was supported by computerized decision support software. Main outcome measures: The base case cost analysis included outpatient, pharmacy, and intervention expenditures. The effectiveness outcomes were depression-free days and quality-adjusted life years (QALYs) calculated using the 12-Item Short Form Health Survey standard gamble conversion formula. Results: The incremental depression-free days outcome was not significant (P = .10); therefore, further cost-effectiveness analyses were not done. The incremental QALY outcome was significant (P = .04) and the mean base case incremental cost-effectiveness ratio was $85 634/QALY. Results adding inpatient costs were $111 999/QALY to $132 175/QALY. Conclusions: In rural settings, a telemedicine-based collaborative care intervention for depression is effective and expensive. The mean base case result was $85 634/QALY, which is greater than cost per QALY ratios reported for other, mostly urban, depression collaborative care interventions.

Archives of general psychiatry · randomised controlled trial · 76 citationsread the source →

Internet-based guided self-help for several anxiety disorders: a randomized controlled trial comparing a tailored with a standardized disorder-specific approach.

Internet-delivered self-help with minimal therapist guidance has shown promising results for a number of diagnoses. Most of the evidence comes from studies evaluating standardized disorder-specific treatments. A recent development in the field includes transdiagnostic and tailored Internet-based treatments that address comorbid symptoms and a broader range of patients. This study evaluated an Internet-based tailored guided self-help treatment, which targeted symptoms of social anxiety disorder, panic disorder with or without agoraphobia, and generalized anxiety disorder. The tailored treatment was compared both with standardized disorder-specific Internet-based treatment and with a wait-list control group. Both active treatment conditions were based on cognitive-behavioral therapy and lasted for 8 weeks. A total of 132 individuals meeting diagnostic criteria for at least one of the anxiety disorders were randomly assigned to 1 of the 3 conditions. Both treatment groups showed significant symptom reductions as compared with the wait-list control group on primary disorder-unspecific measures of anxiety, depression, and general symptomatology and on secondary anxiety disorder-specific measures. Based on the intention-to-treat sample, mean between-group effect sizes were d = 0.80 for the tailored treatment and d = 0.82 for the standardized treatment, versus wait-list controls. Treatment gains were maintained at 6-month follow-up. No differences were found between the 2 active treatment conditions on any of the measures, including a telephone-administered diagnostic interview conducted at posttreatment. The findings suggest that both Internet-based tailored guided self-help treatments and Internet-based standardized treatments are promising treatment options for several anxiety disorders.

Psychotherapy (Chicago, Ill.) · randomised controlled trial · 99 citationsread the source →

Intergenerational programming of impaired nephrogenesis and hypertension in rats following maternal protein restriction during pregnancy.

Associations between birth weight and CVD in adult life are supported by experiments showing that undernutrition in fetal life programmes blood pressure. In rats, the feeding of a maternal low-protein (MLP) diet during gestation programmes hypertension. The present study aimed to assess the potential for a nutritional insult to impact across several generations. Pregnant female Wistar (F0) rats were fed a control (CON; n 10) or MLP (n 10) diet throughout gestation. At delivery all animals were fed a standard laboratory chow diet. At 10 weeks of age, F1 generation offspring were mated to produce a second generation (F2) without any further dietary change. The same procedure produced an F3 generation. Blood pressure in all generations was determined at 4, 6 and 8 weeks of age and nephron number was determined at 10 weeks of age. F1 generation MLP-exposed offspring exhibited raised (P < 0.001) systolic blood pressure (male 143 (sem 4) mmHg; female 141 (sem 4) mmHg) compared with CON animals (male 132 (sem 3) mmHg; female 134 (sem 4) mmHg). Raised blood pressure and reduced nephron number was also noted in the F2 generation (P < 0.001) and this intergenerational transmission occurred via both the maternal and paternal lines, as all three possible offspring crosses (MLP x CON, CON x MLP and MLP x MLP) were hypertensive (132 (sem 3) mmHg) compared with CON animals (CON x CON; 123 (sem 2) mmHg). No effect was noted in the F3 generation. It is concluded that fetal protein restriction may play a critical role in determining blood pressure and overall disease risk in a subsequent generation.

The British journal of nutrition · cohort or longitudinal · 99 citationsread the source →

Music interventions for improving psychological and physical outcomes in cancer patients.

Background: Having cancer may result in extensive emotional, physical and social suffering. Music interventions have been used to alleviate symptoms and treatment side effects in cancer patients. Objectives: To assess and compare the effects of music therapy and music medicine interventions for psychological and physical outcomes in people with cancer. Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2016, Issue 1), MEDLINE, Embase, CINAHL, PsycINFO, LILACS, Science Citation Index, CancerLit, CAIRSS, Proquest Digital Dissertations, ClinicalTrials.gov, Current Controlled Trials, the RILM Abstracts of Music Literature, http://www.wfmt.info/Musictherapyworld/ and the National Research Register. We searched all databases, except for the last two, from their inception to January 2016; the other two are no longer functional, so we searched them until their termination date. We handsearched music therapy journals, reviewed reference lists and contacted experts. There was no language restriction. Selection criteria: We included all randomized and quasi-randomized controlled trials of music interventions for improving psychological and physical outcomes in adult and pediatric patients with cancer. We excluded participants undergoing biopsy and aspiration for diagnostic purposes. Data collection and analysis: Two review authors independently extracted the data and assessed the risk of bias. Where possible, we presented results in meta-analyses using mean differences and standardized mean differences. We used post-test scores. In cases of significant baseline difference, we used change scores. Main results: We identified 22 new trials for inclusion in this update. In total, the evidence of this review rests on 52 trials with a total of 3731 participants. We included music therapy interventions offered by trained music therapists, as well as music medicine interventions, which are defined as listening to pre-recorded music, offered by medical staff. We categorized 23 trials as music therapy trials and 29 as music medicine trials. The results suggest that music interventions may have a beneficial effect on anxiety in people with cancer, with a reported average anxiety reduction of 8.54 units (95% confidence interval (CI) -12.04 to -5.05, P < 0.0001) on the Spielberger State Anxiety Inventory - State Anxiety (STAI-S) scale (range 20 to 80) and -0.71 standardized units (13 studies, 1028 participants; 95% CI -0.98 to -0.43, P < 0.00001; low quality evidence) on other anxiety scales, a moderate to strong effect. Results also suggested a moderately strong, positive impact on depression (7 studies, 723 participants; standardized mean difference (SMD): -0.40, 95% CI -0.74 to -0.06, P = 0.02; very low quality evidence), but because of the very low quality of the evidence for this outcome, this result needs to be interpreted with caution. We found no support for an effect of music interventions on mood or distress. Music interventions may lead to small reductions in heart rate, respiratory rate and blood pressure but do not appear to impact oxygen saturation level. We found a large pain-reducing effect (7 studies, 528 participants; SMD: -0.91, 95% CI -1.46 to -0.36, P = 0.001, low quality evidence). In addition, music interventions had a small to moderate treatment effect on fatigue (6 studies, 253 participants; SMD: -0.38, 95% CI -0.72 to -0.04, P = 0.03; low quality evidence), but we did not find strong evidence for improvement in physical functioning. The results suggest a large effect of music interventions on patients' quality of life (QoL), but the results were highly inconsistent across studies, and the pooled effect size for the music medicine and music therapy studies was accompanied by a large confidence interval (SMD: 0.98, 95% CI -0.36 to 2.33, P = 0.15, low quality evidence). A comparison between music therapy and music medicine interventions suggests a moderate effect of music therapy interventions for patients' quality of life (QoL) (3 studies, 132 participants; SMD: 0.42, 95% CI 0.06 to 0.78, P = 0.02; very low quality evidence), but we found no evidence of an effect for music medicine interventions. A comparison between music therapy and music medicine studies was also possible for anxiety, depression and mood, but we found no difference between the two types of interventions for these outcomes. The results of single studies suggest that music listening may reduce the need for anesthetics and analgesics as well as decrease recovery time and duration of hospitalization, but more research is needed for these outcomes. We could not draw any conclusions regarding the effect of music interventions on immunologic functioning, coping, resilience or communication outcomes because either we could not pool the results of the studies that included these outcomes or we could only identify one trial. For spiritual well-being, we found no evidence of an effect in adolescents or young adults, and we could not draw any conclusions in adults. The majority of studies included in this review update presented a high risk of bias, and therefore the quality of evidence is low. Authors' conclusions: This systematic review indicates that music interventions may have beneficial effects on anxiety, pain, fatigue and QoL in people with cancer. Furthermore, music may have a small effect on heart rate, respiratory rate and blood pressure. Most trials were at high risk of bias and, therefore, these results need to be interpreted with caution.

The Cochrane database of systematic reviews · meta-analysis · 177 citationsread the source →

Early adolescent outcomes of institutionally-deprived and non-deprived adoptees. II: language as a protective factor and a vulnerable outcome.

Background: There is uncertainty about the extent to which language skills are part of general intelligence and even more uncertainty on whether deprivation has differential effects on language and non-language skills. Methods: Language and cognitive outcomes at 6 and 11 years of age were compared between a sample of 132 institution-reared Romanian children adopted into UK families under the age of 42 months, and a sample of 49 children adopted within the UK under the age of 6 months who had not experienced either institutional rearing or profound deprivation. Results: The effects of institutional deprivation were basically similar for language and cognitive outcomes at age 6; in both there were few negative effects of deprivation if it ended before the age of 6 months and there was no linear association with duration of deprivation within the 6 to 42 month range. For the children over 18 months on arrival (range 18-42 months), the presence of even very minimal language skills (imitation of speech sounds) at the time of arrival was a strong beneficial prognostic factor for language and cognitive outcomes, but not for social/emotional/behavioural outcomes. Individual variations in adoptive parent characteristics were unrelated to differences in language or cognitive outcomes, possibly as a consequence of the limited variability in the adoptive family group. Conclusions: Minimal language probably indexes some form of cognitive reserve that, in turn, indexes the degree of institutional deprivation.

Journal of child psychology and psychiatry, and allied disciplines · 48 citationsread the source →

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

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

The Lancet. Digital health · 118 citationsread the source →

A longitudinal investigation of the role of parental responses in predicting children's post-traumatic distress.

Background: While parental post-trauma support is considered theoretically important for child adjustment, empirical evidence concerning the specific aspects of parental responding that influence child post-traumatic distress, or the processes via which any such impacts occur, is extremely limited. We conducted a longitudinal examination of whether parental post-trauma appraisals, trauma-specific support style and general parenting style predicted child post-traumatic stress symptom severity (PTSS) following trauma; and whether such influences operated via the child's own appraisals and coping style. Method: We recruited 132 parent-child pairs following children's experience of acute trauma. We examined whether parental responses assessed at 1-month post-trauma, predicted child PTSS at 6-month follow-up. Parental trauma-specific appraisals and responses, and general parenting style, were assessed via both self-report and direct observations. Child-report questionnaires were used to assess PTSS and potential mediators. Results: Initial parent negative appraisals and encouragement of avoidant coping were associated with higher child-reported PTSS at 6-month follow-up. Predictive effects were maintained even when controlling for initial child symptom levels. Observational assessments broadly supported conclusions from self-report. There was evidence that parental influences may operate, in part, by influencing the child's own appraisals and coping responses. In contrast, there was no evidence for an influence of more "adaptive" support or general parenting style on child PTSS. Conclusions: Findings provide important insight into how elements of social support may influence child post-trauma outcomes.

Journal of child psychology and psychiatry, and allied disciplines · 39 citationsread the source →

Socioeconomic Associations with ADHD: Findings from a Mediation Analysis.

Background: Children from disadvantaged socioeconomic backgrounds are at greater risk of a range of negative outcomes throughout their life course than their peers; however the specific mechanisms by which socioeconomic status relates to different health outcomes in childhood are as yet unclear. Aims: The current study investigates the relationship between socioeconomic disadvantage in childhood and attention deficit/hyperactivity disorder (ADHD), and investigates putative mediators of this association in a longitudinal population-based birth cohort in the UK. Methods: Data from the Avon Longitudinal Study of Parents and Children was used (n = 8,132) to explore the relationship between different measures of socioeconomic status at birth-3 years and their association with a diagnosis of ADHD at age 7. A multiple mediation model was utilised to examine factors occurring between these ages that may mediate the association. Results: Financial difficulties, housing tenure, maternal age at birth of child and marital status were significantly associated with an outcome of ADHD, such that families either living in financial difficulty, living in council housing, with younger or single mothers' were more likely to have a child with a research diagnosis of ADHD at age 7. Financial difficulties was the strongest predictor of ADHD (OR 2.23 95% CI 1.57-3.16). In the multiple mediation model, involvement in parenting at age 6 and presence of adversity at age 2-4 mediated 27.8% of the association. Conclusions: Socioeconomic disadvantage, conceptualised as reported difficulty in affording basic necessities (e.g. heating, food) has both direct and indirect impacts on a child's risk of ADHD. Lower levels of parent involvement mediates this association, as does presence of adversity; with children exposed to adversity and those with less involved parents being at an increased risk of having ADHD. This study highlights the importance of home and environmental factors as small but important contributors toward the aetiology of ADHD.

PloS one · 100 citationsread the source →

Assessment of Parents' Preferences for Incentives to Promote Engagement in Family-Based Childhood Obesity Treatment.

Importance: Family-based treatment (FBT) is recommended for childhood obesity, but even when sought, attrition is high. Extrinsic incentives, which have been effective for improving adult health, could improve FBT engagement. Objective: To assess parents' preferences for FBT incentives. Design, setting, and participants: Survey study of parents of children aged 6 to 17 years with obesity (body mass index in ≥95th percentile for age and sex). Parents' preferences for FBT incentive program attributes were assessed in a discrete choice experiment conducted using a nationally representative, web-based survey in March 2018. Attributes included (1) the monetary value of the incentive, (2) the payment structure, (3) the goal being incentivized, and (4) the person(s) being incentivized. A fractional factorial design was used to create a set of profiles representing hypothetical FBT incentives. Parents were presented with 10 pairs of profiles and asked which would most motivate them in FBT. Parents were also asked about preferences between a small, guaranteed incentive and a lottery for a large incentive. Analyses used a hierarchical Bayesian model and linear regressions. Main outcomes and measures: Parents' preference for different incentive program attributes and levels. Results: The nationally representative survey had a 41.4% eligibility rate (n = 339) and a 89.7% completion rate (n = 304). A total of 53.3% of respondents (weighted percentage) were non-Hispanic white, 42.6% had an annual household income less than $50 000, and 28.3% had a bachelor's degree. Parents preferred higher incentives, although they were willing to accept lower-value incentives if both the parent and the child (vs the child alone) were required to meet the goal (mean difference [MD], -$108; 95% CI, -$132 to -$84), if the incentive used a gain-framed vs loss-framed payment structure (MD, -$72; 95% CI, -$85 to -$59), and if physical activity goals were incentivized over weight loss (MD, -$63; 95% CI, -$82 to -$44) or dietary monitoring (MD, -$5; 95% CI, -$1 to $28). Only 20.6% of parents preferred a lottery over a guaranteed payment. Preferences did not vary among demographic or health subgroups. Conclusions and relevance: In this study, parent-stated preferences did not align with FBT best practices or behavioral economic theory. A randomized clinical trial could examine whether aligning incentives with preferences or best practices would maximize FBT engagement and behavior change.

JAMA network open · 13 citationsread the source →

Effect of exclusive breastfeeding on selected adverse health and nutritional outcomes: a nationally representative study.

Background: Despite growing evidence in support of exclusive breastfeeding (EBF) among infants in the first 6 months of birth, the debate over the optimal duration of EBF continues. This study examines the effect of termination of EBF during the first 2, 4 and 6 months of birth on a set of adverse health and nutritional outcomes of infants. Methods: Three waves of Bangladesh Demographic and Health Survey data were analysed using multivariate regression. The adverse health outcomes were: an episode of diarrhea, fever or acute respiratory infection (ARI) during the 2 weeks prior to the survey. Nutritional outcomes were assessed by stunting (height-for-age), wasting (weight-for-height) and underweight (weight-for-age). Population attributable fraction was calculated to estimate percentages of these six outcomes that could have been prevented by supplying EBF. Results: Fifty-six percent of infants were exclusively breastfed during the first 6 months. Lack of EBF increased the odds of diarrhea, fever and ARI. Among the babies aged 6 months or less 27.37% of diarrhea, 13.24% of fever and 8.94% of ARI could have been prevented if EBF was not discontinued. If EBF was terminated during 0-2 months, 2-4 months the odds of becoming underweight were 2.16 and 2.01 times higher, respectively, than babies for whom EBF was not terminated. Conclusion: Children who are not offered EBF up to 6 months of their birth may suffer from a range of infectious diseases and under-nutrition. Health promotion and other public health interventions should be enhanced to encourage EBF at least up to six-month of birth. Trail registration: Data of this study were collected following the guidelines of ICF International and Bangladesh Medical Research Council. The registration number of data collection is 132,989.0.000 and the data-request was registered on September 11, 2016.

BMC public health · 54 citationsread the source →

Maternal depression and child development

Maternal depression is considered a risk factor for the socioemotional and cognitive development of children [1]. The current prevalence of depression in Canada averages at 6%, which is similar to the rates in other western countries [2] (the female-to-male ratio average is 2:1 [3]). However, the prevalence of postpartum depression is approximately 13% [4]. Women of childbearing age are particularly at risk for depression, and many of them experience high levels of social morbidity and depressive symptoms that are often unrecognized and untreated. Mothers already at risk for depression are particularly fragile during the first months postpartum. Maternal depression has consequences on the child’s development. Because physicians who care for infants and children encounter mothers repeatedly, it is important that they have the knowledge and skills for the detection of symptoms of maternal depression. The objectives of this statement are: To review the present knowledge on the consequences of maternal depression on the development of children at various ages; To review the evidence-based literature on the treatment of maternal depression and its impact on newborns, infants and children; and To review the role of the child’s physician in the detection of symptoms of maternal depression, and the coordination of appropriate support and management. A literature search for the past 15 years was conducted using the MEDLINE database, and by reviewing the bibliographies of the retrieved articles. Of particular interest were the prospective longitudinal cohort studies in which mothers were recruited during their pregnancy or postpartum period, and the children were assessed at regular intervals. Postpartum psychiatric disorders are generally divided into three categories: postpartum blues, postpartum psychosis and postpartum depression. Postpartum blues is a relatively common emotional disturbance with crying, confusion, mood lability, anxiety and depressed mood. The symptoms appear during the first week postpartum, last for a few hours to a few days and have few negative sequelae. At the other end of the spectrum, postpartum psychosis refers to a severe disorder beginning within four weeks postpartum, with delusions, hallucinations and gross impairment in functioning. Postpartum depression begins in or extends into the postpartum period and core features include dysphoric mood, fatigue, anorexia, sleep disturbances, anxiety, excessive guilt and suicidal thoughts [5]. The diagnosis requires that symptoms be present for at least one month and result in some impairment in the woman’s functioning [6]. Women who have experienced postpartum depression have a 50% to 62% risk for future depressions [7]. Other risk factors for postpartum depression include a history of mood disorders, depression symptoms during the pregnancy and a family history of psychiatric disorders [4]. Stress factors, such as negative life events, poor marital relationships, having a special needs infant or medically ‘fragile’ infant, lack of social support, drug abuse, and personal and family psychopathology, have been associated with postpartum depression in some studies, but other studies have found no association [6]. Postpartum depression tends to be milder than episodes of depression that occur at other times, with lower levels of anxiety, agitation, insomnia and somatic symptoms [8]. However, the duration seems to be the same in postpartum and nonpostpartum depression, and lasts several months [6]. The consequences on the child of maternal postpartum depression are not restricted to infancy, but can extend into toddlerhood, preschool age and even school age. Maternal depression that occurs later influences the development of the school-age child and the adolescent. Table 1 summarizes the consequences of maternal depression from prenatal issues to adolescence. Consequences of maternal depression Consequences of maternal depression The associations between maternal depression, maternal behaviour and child outcomes are complex, and not all studies have found a relationship between maternal depression and indicators of poor parenting. Variations in the type, severity, chronicity and timing of maternal depression [9], heterogeneity in sampling (community versus high-risk multiproblem samples), and potentiating risk factors, such as family adversity, low social support and financial stress [10], all contribute to differences in outcomes in children. On the other hand, stress factors can be responsible for adverse child outcomes in the absence of maternal depression. On a daily basis, infants repeatedly participate in interactive routines with their mothers. Maternal depression compromises the dyad’s capacity to mutually regulate the interaction, through two interactive patterns, intrusiveness or withdrawal. Intrusive mothers display a hostile affect, and disrupt the infant’s activity. The infants experience anger, turn away from the mother to limit her intrusiveness and internalize an angry and protective style of coping. Withdrawn mothers are disengaged, unresponsive, affectively flat and do little to support the infant’s activity. The infants are unable to cope or self-regulate this negative state, and develop passivity, withdrawal and self-regulatory behaviours (eg, looking away or sucking on thumb) [11],[12]. Infants of postnatally depressed mothers have been reported to show patterns of dysregulated attention and arousal. In a study by Murray [13], cognitive performance regarding the independent existence of objects was worse for infants of 61 postnatally depressed mothers than the infants of 42 nondepressed mothers, even after adjustment for contextual adversity. Depressed mothers are less likely to offer contingent stimulation to their infants [14], and this disrupts their performance on nonsocial learning tasks [15]. Another factor that may interfere with learning is the negative affect shown by infants of depressed mothers, even when they are interacting with nondepressed adults [16]. It has been documented that an infant’s own negative affect interferes with learning and the ability to process information [17]. Depressed mothers generally show less attentiveness and responsiveness to their children’s needs. They are also poor models for negative mood regulation and problem solving. Longitudinal studies have compared the behaviours of depressed and nondepressed mothers, and the outcome of their children. They showed that depressed mothers were less likely to set limits on their children and to follow through if they did set limits [18]. Children of depressed mothers appeared more passively noncompliant, with less mature expressions of age-appropriate autonomy [19]. They were rated by their dysphoric mothers as being more vulnerable, and having more internalizing (depressed) and externalizing problems (aggressive and destructive), which are associated with lower interaction ratings [20]. They were also more likely to respond negatively to friendly approaches, more likely to engage in low-level physical play and less likely to engage in individual creative play than control children [21]. These aspects of child behaviour were associated with postnatal depression, even when taking adverse situations such as marital conflict, and demographic variables, such as maternal age, ethnicity, socioeconomic status, marital status, child’s age and number of siblings, into account. Studies on large samples all agree on the negative impact of maternal postpartum depression on a child’s cognitive development. Early experience with insensitive maternal interactions (as in maternal postpartum depression) appears to be predictive of poorer cognitive functioning [22]. Boys may be more sensitive than girls to the effects of the mother’s illness. In a study by Sharp et al [23], only boys showed a decrease on standardized tests of intellectual attainment (mainly on indexes of abstract intelligence, reasoning about opposites and analogies) and the “draw-a-child” task. Other aspects of cognitive development, such as cognitive-linguistic functioning [24], have also been shown to be negatively affected, and there were also deficits on the perceptual and performance scale [25]. Outcome effects were independent of birth order, maternal education, family income, marital status and social support. Various studies have shown that school-age children of depressed mothers display impaired adaptive functioning, including internalizing and externalizing problems. Although the studies reviewed by Beardslee et al [26] were uncontrolled studies, a more recent review by Downey and Coyne [27] included studies using control groups (matched for age of parents, occupational status, ethnicity, marital status, and number and age of children), standardized diagnostic criteria to identify parental depression and valid measures of psychological functioning in children. Billings and Moos [28] showed that family stress and low support added to the prediction of child disturbance beyond that accounted for by having a depressed parent. However, the study of Lee and Gotlib [29] comparing children of depressed psychiatric mothers and nondepressed psychiatric mothers showed that the child’s adjustment was more strongly related to the severity of maternal psychopathology than to diagnosis status. Children of depressed parents are also at higher risk of psychopathology, including affective (mainly depression), anxiety and conduct disorders. Hammen et al [30] compared children from four groups of mothers (mothers with unipolar disorder, bipolar disorder and chronic medical illness, and normal mothers) with no differences in ethnicity, age, socioeconomic status or educational level. They showed that, even with the effects of chronic stress statistically controlled, there were still differences in the psychosocial outcome variables among groups, and there was particular impairment in children of unipolar mothers [30]. Other studies [31]–[34], in which there were no demographic differences (age, marital status and socioeconomic level) between depressed and nondepressed parents, have confirmed an increased risk of psychopathology in the children of depressed parents. It seems that onset of a major depression disorder before 30 years of age in parents increases the risk of their children developing depression quite early during childhood [33],[34]. It is somewhat difficult to delineate which behavioural disorders are due to maternal depression and other environmental factors, and which are due to genetic susceptibility. There seems to be an association between attention deficit/hyperactivity disorder (ADHD) in children and maternal mental health, as shown by a cross-sectional study by Lesesne et al [35]. Using the 1998 National Health Interview Study on 9529 mother-child dyads, they found an association between an activity-limiting depression, anxiety or emotional problem in mothers, and ADHD in their children aged four to 17 years, even after adjusting for the child’s age, sex, race, household income and type of family structure [35]. In a longitudinal study of 132 children by Hay et al [36], lower IQ scores, attentional problems, difficulties in mathematical reasoning and special educational needs were significantly more frequent in children whose mothers were depressed at three months postpartum than in controls. In addition, boys were more affected than girls. However, academic difficulties in children of depressed mothers were not mediated by parental IQ, sociodemographic variables or the mother’s mental health after the postpartum depressive episode. Generally, adolescence is a vulnerable period for affective illness and major depressive disorder, which are observed twice as often in girls than in boys [37]. Two cross-sectional studies showed that adolescents with a depressed parent suffered from psychosocial maladjustment [38] and experienced a significantly higher rate of affective disorder than adolescents of nonaffective psychiatric control parents [39]. Longitudinal studies have consistently reported higher rates of major depression and other psychopathology (anxiety disorders, conduct disorders and substance abuse disorders) in adolescents with an affectively ill parent than in control families with similar demographic characteristics (age, ethnicity, socioeconomic status and educational level). Hammen et al [40] followed a cohort of 92 children/adolescents between the ages of eight and 16 years over a three-year They found that children/adolescents with mothers from unipolar depression higher rates of affective disorders, with frequent the disorders in children/adolescents with mothers from bipolar depression were less et al families with children between and years over a They observed higher rates of major depression, disorder and in the of depressed parents than in the major depression onset was between the ages of 15 and Beardslee et al at an of a health with children between the ages of and At the of the children/adolescents with an affectively ill parent at least one of an affective illness compared with in the control years the rates of affective disorders were and and of affectively ill parents onset and a number of in school-age ADHD and learning into adolescence [35]. It has been in many studies that some children with depressed do not display behavioural and that some factors may or the effects of parental depression contextual risk factors, marital life social support lower social and lower maternal are factors that may parental depression and parenting. In a study of mothers with major depressive disorder the child’s et al showed that contextual risk factors mediated the between maternal depression and child behaviour problems. The role of and in child development are to be on mothers, the for the infant is the However, in their study of to et al showed that infants of depressed mothers with their nondepressed who the effects of the mother’s depression on infant interaction In addition, a cross-sectional study of families with children between the ages of and years showed that in families in which the mother was children showed lower social and emotional if the also a psychiatric The role of has been in the of marital to a review by Downey and Coyne marital to children externalizing problems, and increases their risk for depression by and parental depression. differences have been in some studies with boys being more vulnerable and by maternal depression than girls. of the child also to the of parental depression. It has been shown that mothers more negative of their child’s less in their parental and more often A child with a more and be more to their depressed mother’s negative behaviour and not show a of Other of in children include social and cognitive skills that them attention from adults other than their depressed parents and their depressed of and It seems that an of the illness and by the child that or is not to for the behaviour is important to the development of in a child Although the interaction between parents and their child is beyond the of the present it has been that parents of children higher depression than control parents and that is a of maternal depression Because many depressive episodes occur during childbearing years, the to be between the mother’s and a who from depression with is at high risk of [7]. during pregnancy is associated with prenatal poor higher low birth substance abuse and The morbidity of depression during pregnancy be the risk of have been by that are associated with a low risk of and the However, et al did not in major or in taking compared with controls. Another study on taking showed an in when the was during the In the period, it seems that behavioural and rate to are in infants to in et al compared children of mothers with a during children of mothers with and control children of nondepressed mothers who did not during adjusting for the duration and severity of maternal depression, duration of number of depressive episodes after maternal IQ and socioeconomic status, the study showed that and no adverse effects on the IQ, development or behaviour of children between 15 and months of age In a et al compared children to depressed mothers who not to during pregnancy and children to mothers with Although the on the indexes were similar in groups of children to children to lower on the indexes and the factors of the of the of is the of It is important that a depressed mother who to be the is in the postnatal period, there is a risk of with negative consequences on the emotional and behavioural development of the On the other hand, all are in of the information from and to a review by and the and are the of or have been in children or through To infant when postpartum depressed mothers, it is important to all maternal of and and to the of environmental and maternal illness is interaction with the infant or other it is to on the of treatment it is to the of the be on the mother’s and experience of adverse effects with a particular risk of interactions with and adverse effects associated with a particular on mothers and their Maternal be to for the that control of the depressive is and the in pregnancy be in the postnatal The infant’s to can be by the of and it and approximately to after the mother has the Although there is no on the of during pregnancy and be considered in the of a as by the of et al be considered in who have to severe symptoms and who have not to show that and appear to be quite during pregnancy and the postnatal period, and may be during pregnancy and Because of the consequences of maternal depression on an infant’s development, many studies have postnatal mothers. have on the mother’s mood state, her to or of the infant’s and the negative about the infant’s behaviours [16]. to the of by mothers to their infants or by mothers to and their attention support and have been in depressed and as as their and development treatment have been an interactive treatment at problems by the mother in the of her infant that support, and education, with of depressed mothers and their a and in a infant over a period to of months mothers from the showed more interaction and their infants and scores, as as more interaction behaviours than in the control children and adolescents from families with a depressed parent may from a on about the illness within the family and on the development of in the In a study by Beardslee et al families who an to child and a parent with an affective disorder were to a or a parents information about the and symptoms of childhood and depression, and the for within the However, the cognitive to the life of the in the showed more behaviour and among parents and including higher levels of from parents to children about the illness and by the child of the affective illness et al compared with interaction The treatment on the mother’s of her infant and her relationship with the infant, and aspects of the mother’s own childhood and early already the interaction to identify behaviours and to of an infant’s a of there was a in The sleep and difficulties maternal to increased and control In addition, maternal and infants more less and showed more on and problems experienced by depressed postpartum mothers. In a study of depressed postpartum depressive symptoms and social adjustment in the compared with the control on the has also been in the of postpartum depression in with at least one risk factor for postpartum depression and are and is the in Canada seems to be for to depression, it has many drug interactions There are no on its and it be as during pregnancy on its during are a it was observed that was in at a low and the lower limit of in the infant’s A prospective study of found no differences in the of in over the first of life compared with a control to the of the on the Health to of for depression using the Health or the of of from the Health However, it is strongly that a high of for depression among their In their statement the adults for depression in that have in to treatment and of of In their for the of on the that the physical and mental health of the parents in their and review the of attention to their own mental health needs. In a of three et al reported that more than of mothers the impact of depression on the child’s health and and that more than of mothers the role in and to However, a recent study showed that maternal depression was by health care et al reported that in their ability to maternal depression and their of knowledge and The role in maternal depression be one of followed by for and There be a about family history of depression and about episodes of maternal depression. have been and to postpartum depression of that may information about postpartum depression are in Table depression is the can and with the mother’s physician or an appropriate to psychiatric between the mother’s physician and the child’s physician is to information about postpartum depression are about being a that is or difficult to care are in is the past have often been by depressed or the past have often been by having little interest or in are about being a that is or difficult to care are in is the past have often been by depressed or the past have often been by having little interest or in to information about postpartum depression are about being a that is or difficult to care are in is the past have often been by depressed or the past have often been by having little interest or in are about being a that is or difficult to care are in is the past have often been by depressed or the past have often been by having little interest or in many mothers, care may be their with health care The child’s physician may be the first to of the and difficulties of a the child’s physician can the depressed mother her mood affect her and contribute to the child’s problems. of include infant sleep problems, child social and family It is important to a high of of maternal depression when child behaviour problems are during a medical for the depression of the mother over behavioural for the Because postpartum depression can have effects on mothers and children and its prevalence occurs at approximately three it has been to for postpartum depression at the and care In school-age children and the of difficulties in child adjustment and impaired functioning at and in school the physician to the of maternal depression. in families with a history of depression, one in that may depressed or display other psychopathology, at adolescence. These often and for a for the The child’s physician has a role in to the appropriate for the and the parent. that children of depressed mothers are at risk for and behavioural problems, as as their for developing a depressive disorder the physician conduct regular of the offer and them early for more and of and behavioural disorders. Postpartum depression occurs in approximately 13% of and often it is there is often a of between and psychiatric and treatment of the lack of The infant of a depressed mother is at risk for developing negative affect and dysregulated attention and arousal. and of depressed mothers are at risk for developing poor internalizing and externalizing problems, and difficulties in cognitive functioning and in social interactions with parents and and children of depressed parents are at risk for impaired adaptive functioning and psychopathology, including conduct disorders, affective disorders and anxiety disorders. They are also at risk for ADHD and learning risk factors such as marital and life may parental depression and child behaviour problems. On the other hand, some children develop through an social cognitive skills and of the illness. with during pregnancy and is but no major or physical and to the or the infant have been The of the mother’s depression to the low of on the or the the of the and development of infants and the physician to of mother-child interaction and behavioural and problems in the such they in the of maternal depression, a few and with the mother’s physician or psychiatric Mothers who have during pregnancy be that of the to that there is no increased risk of or Mothers who have during pregnancy be about the of their child studies have not shown adverse for differences whose to be Mothers who have during be that of the to that there are no or in children to such through Mothers be that on are and that such not be during pregnancy and on of and of of The in this statement do not an of treatment or to be taking into individual may be are current at of

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