Randomised trials are a central component of all evidence-informed health care systems and the evidence coming from them helps to support health care users, health professionals and others to make more informed decisions about treatment. The evidence available to trialists to support decisions on design, conduct and reporting of randomised trials is, however, sparse. Trial Forge is an initiative that aims to increase the evidence base for trial decision-making and in doing so, to improve trial efficiency.One way to fill gaps in evidence is to run Studies Within A Trial, or SWATs. This guidance document provides a brief definition of SWATs, an explanation of why they are important and some practical ‘top tips’ that come from existing experience of doing SWATs. We hope the guidance will be useful to trialists, methodologists, funders, approvals agencies and others in making clear what a SWAT is, as well as what is involved in doing one.
Background: Understanding why people take part in health research is critical to improve research efficiency and generalisability. The aim of this overview of systematic reviews was to identify psychosocial determinants of research participation and map them to psychological theory and empirical recruitment research, to identify effective strategies to increase research participation. Methods: Qualitative and quantitative systematic reviews were systematically identified. No date or language limits were applied. Two reviewers independently selected reviews. Methodological quality was rated using AMSTAR, and poor-quality reviews (scoring 0-3) were excluded. Barriers and facilitators were coded to psychological theory (Theoretical Domains Framework) and empirical recruitment research (recruitment interventions that had been subjected to randomised controlled trial evaluation). Results: We included 26 systematic reviews (429 unique primary studies), covering a wide range of patient populations and health settings. We identified five groups of facilitators, of which three were dominant (potential for personal benefit, altruism, trust) and appear to be relevant across research setting and design. We identified nine groups of barriers, which were more dependent on the particular study (context, population, design). Two determinants (participant information, social influences) were found to be both barriers and facilitators. Barriers and facilitators could be coded to the Motivation and Opportunity components of the Theoretical Domains Framework; only one was coded to a Capability component. There was some overlap between psychosocial determinants and empirical recruitment research, but some barriers and facilitators had not been tested at all. Conclusions: Identifying effective recruitment strategies could increase the efficiency and generalisability of primary research. We identified a number of barriers and facilitators that could be addressed by researchers. There is a need for more research to identify effective recruitment strategies that draw on the psychosocial facilitators and barriers identified in this overview.
Certolizumab pegol (CZP), an anti-tumor necrosis factor a agent, is an effective therapy for Crohn's disease (CD). A population pharmacokinetic (PK) analysis of subcutaneously administered CZP was performed using data from 2157 CD patients from 9 separate studies. The aim was to determine which covariates influence the disposition of CZP. The final CZP population PK model consisted of a baseline, first-order absorption, and 1-compartment disposition. CZP antibodies were treated as a structural model covariate and caused apparent clearance (CL/F) to increase from 0.685 to 2.74 L/day. Body surface area (BSA) influenced both CL/F and apparent volume of distribution (V/F) in a linear fashion; both parameters increased by more than 53% and 49%, respectively, across the range of BSA measurements in the data. Albumin influenced CZP CL/F in a nonlinear fashion; CL/F decreased from 1.05 to 0.613 L/day with increasing albumin concentrations in antibody-negative patients. C-reactive protein (CRP) had a borderline influence and CL/F increased by more than 20% across the range of CRP measurements in the data set. Race had a minor influence on V/F. The determined covariates' impact on CZP disposition may be of clinical utility in CZP therapy of CD patients when the PK/pharmacodynamic relationship becomes available.
Aim To evaluate the effectiveness of pharmacological interventions for managing non‐respiratory sleep disturbances in children with neurodisabilities. Method We performed a systematic review and meta‐analyses of randomized controlled trials ( RCT s). We searched 16 databases, grey literature, and reference lists of included papers up to February 2017. Data were extracted and assessed for quality by two researchers (B.B., C.M., G.S., A.S., A.P.). Results Thirteen trials were included, all evaluating oral melatonin. All except one were at high or unclear risk of bias. There was a statistically significant increase in diary‐reported total sleep time for melatonin compared with placebo (pooled mean difference 29.6min, 95% confidence interval [ CI ] 6.9–52.4, p =0.01). Statistical heterogeneity was high (97%). For the single RCT with low risk of bias, the unadjusted mean difference in total sleep time was 13.2 minutes (95% CI −13.3 to 39.7) favouring melatonin, while the mean difference adjusted for baseline total sleep time was statistically significant (22.4min, 95% CI 0.5–44.3, p =0.04). Adverse event profile suggested that melatonin was well‐tolerated. Interpretation There is a paucity of evidence on managing sleep disturbances in children with neurodisabilities, and it is mostly of limited scope and poor quality. There is evidence of the benefit and safety of melatonin compared with placebo, although the extent of this benefit is unclear. What this paper adds Melatonin for the management of non‐respiratory sleep disturbances in children with neurodisabilities was well tolerated with minimal adverse effects. The extent of benefit and which children might benefit most from melatonin use is uncertain. Benefit may be greatest in those with autism spectrum disorder; however, this finding should be interpreted with caution.
ObjectiveTo identify existing evidence on interagency collaboration between law enforcement, emergency services, statutory services and third sector agencies regarding people with mental ill health.DesignSystematic scoping review. Scoping reviews map particular research areas to identify research gaps.Data sources and eligibilityASSIA, CENTRAL, the Cochrane Library databases, Criminal Justice Abstracts, ERIC, Embase, MEDLINE, PsycINFO, PROSPERO and Social Care Online and Social Sciences Citation Index were searched up to 2017, as were grey literature and hand searches. Eligible articles were empirical evaluations or descriptions of models of interagency collaboration between the police and other agencies.Study appraisal and synthesisScreening and data extraction were undertaken independently by two researchers. Arksey’s framework was used to collate and map included studies.ResultsOne hundred and twenty-five studies were included. The majority of articles were of descriptions of models (28%), mixed methods evaluations of models (18%) and single service evaluations (14%). The most frequently reported outcomes (52%) were ‘organisational or service level outcomes’ (eg, arrest rates). Most articles (53%) focused on adults with mental ill health, whereas others focused on adult offenders with mental ill health (17.4%). Thirteen models of interagency collaboration were described, each involving between 2 and 13 agencies. Frequently reported models were ‘prearrest diversion’ of people with mental ill health (34%), ‘coresponse’ involving joint response by police officers paired with mental health professionals (28.6%) and ‘jail diversion’ following arrest (23.8%).ConclusionsWe identified 13 different interagency collaboration models catering for a range of mental health-related interactions. All but one of these models involved the police and mental health services or professionals. Several models have sufficient literature to warrant full systematic reviews of their effectiveness, whereas others need robust evaluation, by randomised controlled trial where appropriate. Future evaluations should focus on health-related outcomes and the impact on key stakeholders.
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