A systematic review of training programmes for recruiters to randomised controlled trials

BACKGROUND: Recruitment to randomised controlled trials (RCTs) is often difficult. Clinician related factors have been implicated as important reasons for low rates of recruitment. Clinicians (doctors and other health professionals) can experience discomfort with some underlying principles of RCTs and experience difficulties in conveying them positively to potential trial participants. Recruiter training has been suggested to address identified problems but a synthesis of this research is lacking. The aim of our study was to systematically review the available evidence on training interventions for recruiters to randomised trials. METHODS: Studies that evaluated training programmes for trial recruiters were included. Those that provided only general communication training not linked to RCT recruitment were excluded. Data extraction and quality assessment were completed by two reviewers independently, with a third author where necessary. RESULTS: Seventeen studies of 9615 potentially eligible titles and abstracts were included in the review: three randomised controlled studies, two non-randomised controlled studies, nine uncontrolled pre-test/post-test studies, two qualitative studies, and a post-training questionnaire survey. Most studies were of moderate or weak quality. Training programmes were mostly set within cancer trials, and usually consisted of workshops with a mix of health professionals over one or two consecutive days covering generic and trial specific issues. Recruiter training programmes were well received and some increased recruiters’ self-confidence in communicating key RCT concepts to patients. There was, however, little evidence that this training increased actual recruitment rates or patient understanding, satisfaction, or levels of informed consent. CONCLUSIONS: There is a need to develop recruiter training programmes that can lead to improved recruitment and informed consent in randomised trials. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-015-0908-6) contains supplementary material, which is available to authorized users

Does immediate dentin sealing influence postoperative sensitivity in teeth restored with indirect restorations? A systematic review and meta-analysis

Objective: This study comprehensively reviewed clinical trials that investigated the effect of immediate dentin sealing (IDS) technique on postoperative sensitivity (POS) and clinical performance of indirect restorations. Materials and methods: The systematic review was conducted according to the preferred reporting items for systematic reviews and meta-analyses statement, and was guided by the PICOS strategy. Clinical trials in which adult patients received at least one indirect restoration cemented with IDS approach and one restoration cemented following the delayed dentin sealing (DDS) were considered. Results: Following title screening and full-text reading, four studies met the inclusion criteria and were included for qualitative synthesis, while two studies were selected for quantitative synthesis. According to Risk of bias-2 tool, two studies were classified as “some concerns” for the outcome POS. No statistically significant differences were found between teeth restored with indirect restorations using the IDS and DDS approach for POS (p > 0.05), neither at the baseline (very low certainty of evidence according to GRADE) nor after 2 years of follow-up (low certainty of evidence according to GRADE). Conclusion: There is low-certainty evidence that IDS does not reduce POS in teeth restored with indirect restorations. Clinical significance: There is no clinical evidence to favor IDS over DDS when restoring teeth with indirect restorations

Quality of relationships as predictors of outcomes in people with dementia: a systematic review protocol

INTRODUCTION: Serious adverse outcomes for people with dementia include institutionalisation, hospitalisation, death, development of behavioural and psychiatric symptoms, and reduced quality of life. The quality of the relationship between the person with dementia and their informal/family carer is thought to affect the risk of these outcomes. However, little is known about which aspects of relationship quality are important, or how they affect outcomes for people with dementia. METHODS AND ANALYSIS: This will be a systematic review of the literature. Electronic databases MEDLINE, EMBASE, Web of Science, PsycInfo, the Cochrane Database, ALOIS and OpenGrey will be searched from inception. 2 independent reviewers will screen results for eligibility with standardised criteria. Data will be extracted for relevant studies, and information on the associations between relationship quality and dementia outcomes will be synthesised. Meta-analysis will be performed if possible to calculate pooled effect sizes. Narrative synthesis will be performed if study heterogeneity rules out meta-analysis. ETHICS AND DISSEMINATION: Ethical review is not necessary as this review summarises data from previous studies. Results will be disseminated via peer-reviewed publication. Results will also be disseminated to a patient and public involvement group and an expert panel for their views on the findings and implications for future work. TRIAL REGISTRATION NUMBER: CRD42015020518

Pre-admission interventions to improve outcome after elective surgery-protocol for a systematic review

BACKGROUND: Poor physical health and fitness increases the risk of death and complications after major elective surgery. Pre-admission interventions to improve patients’ health and fitness (referred to as prehabilitation) may reduce postoperative complications, decrease the length of hospital stay and facilitate the patient’s recovery. We will conduct a systematic review of RCTs to examine the effectiveness of different types of prehabilitation interventions in improving the surgical outcomes of patients undergoing elective surgery. METHODS: This review will be conducted and reported according to the Cochrane and PRISMA reporting guidelines. MEDLINE, EMBASE, CENTRAL, CINAHL, PsycINFO, ISI Web of Science and clinical trial registers will be searched for any intervention administered before any elective surgery (including physical activity, nutritional, educational, psychological, clinical or multicomponent), which aims to improve postoperative outcomes. Reference lists of included studies will be searched, and grey literature including conference proceedings, theses, dissertations and preoperative assessment protocols will be examined. Study quality will be assessed using Cochrane’s risk of bias tool, and meta-analyses for trials that use similar interventions and report similar outcomes will be undertaken where possible. DISCUSSION: This systematic review will determine whether different types of interventions administered before elective surgery are effective in improving postoperative outcomes. It will also determine which components or combinations of components would form the most effective prehabilitation intervention. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD4201501919

Evidence of detrimental effects of prenatal alcohol exposure on offspring birthweight and neurodevelopment from a systematic review of quasi-experimental studies

Background: Systematic reviews of prenatal alcohol exposure effects generally only include conventional observational studies. However, estimates from such studi

Reducing bias in open-label trials where blinded outcome assessment is not feasible: strategies from two randomised trials

Background Blinded outcome assessment is recommended in open-label trials to reduce bias, however it is not always feasible. It is therefore important to find other means of reducing bias in these scenarios. Methods We describe two randomised trials where blinded outcome assessment was not possible, and discuss the strategies used to reduce the possibility of bias. Results TRIGGER was an open-label cluster randomised trial whose primary outcome was further bleeding. Because of the cluster randomisation, all researchers in a hospital were aware of treatment allocation and so could not perform a blinded assessment. A blinded adjudication committee was also not feasible as it was impossible to compile relevant information to send to the committee in a blinded manner. Therefore, the definition of further bleeding was modified to exclude subjective aspects (such as whether symptoms like vomiting blood were severe enough to indicate the outcome had been met), leaving only objective aspects (the presence versus absence of active bleeding in the upper gastrointestinal tract confirmed by an internal examination). TAPPS was an open-label trial whose primary outcome was whether the patient was referred for a pleural drainage procedure. Allowing a blinded assessor to decide whether to refer the patient for a procedure was not feasible as many clinicians may be reluctant to enrol patients into the trial if they cannot be involved in their care during follow-up. Assessment by an adjudication committee was not possible, as the outcome either occurred or did not. Therefore, the decision pathway for procedure referral was modified. If a chest x-ray indicated that more than a third of the pleural space filled with fluid, the patient could be referred for a procedure; otherwise, the unblinded clinician was required to reach a consensus on referral with a blinded assessor. This process allowed the unblinded clinician to be involved in the patient’s care, while reducing the potential for bias. Conclusions When blinded outcome assessment is not possible, it may be useful to modify the outcome definition or method of assessment to reduce the risk of bias

RoB 2: a revised tool for assessing risk of bias in randomised trials

Assessment of risk of bias is regarded as an essential component of a systematic review on the effects of an intervention. The most commonly used tool for randomised trials is the Cochrane risk-of-bias tool. We updated the tool to respond to developments in understanding how bias arises in randomised trials, and to address user feedback on and limitations of the original tool

A threshold analysis assessed the credibility of conclusions from network meta-analysis

Objective: To assess the reliability of treatment recommendations based on network meta-analysis (NMA)Study design: We consider evidence in an NMA to be potentially biased. Taking each pair-wise contrast in turn we use a structured series of threshold analyses to ask: (a) “How large would the bias in this evidence-base have to be before it changed our decision?” and (b) “If the decision changed, what is the new recommendation?” We illustrate the method via two NMAs in which a GRADE assessment for NMAs has been implemented: weight-loss and osteoporosis.Results. Four of the weight-loss NMA estimates were assessed as “low” and 6 as “moderate” quality by GRADE; for osteoporosis 6 were “low”, 9 “moderate” and 1 “high”. The threshold analysis suggests plausible bias in 3 of 10 estimates in the weight-loss network could have changed the treatment recommendation. For osteoporosis plausible bias in 6 of 16 estimates could change the recommendation. There was no relation between plausible bias changing a treatment recommendation and the original GRADE assessments.Conclusions. Reliability judgements on individual NMA contrasts do not help decision makers understand whether a treatment recommendation is reliable. Threshold analysis reveals whether the final recommendation is robust against plausible degrees of bias in the data

Mechanical versus manual chest compressions in the treatment of in-hospital cardiac arrest patients in a non-shockable rhythm : a randomised controlled feasibility trial (COMPRESS-RCT)

Background Mechanical chest compression devices consistently deliver high-quality chest compressions. Small very low-quality studies suggest mechanical devices may be effective as an alternative to manual chest compressions in the treatment of adult in-hospital cardiac arrest patients. The aim of this feasibility trial is to assess the feasibility of conducting an effectiveness trial in this patient population. Methods COMPRESS-RCT is a multi-centre parallel group feasibility randomised controlled trial, designed to assess the feasibility of undertaking an effectiveness to compare the effect of mechanical chest compressions with manual chest compressions on 30-day survival following in-hospital cardiac arrest. Over approximately two years, 330 adult patients who sustain an in-hospital cardiac arrest and are in a non-shockable rhythm will be randomised in a 3:1 ratio to receive ongoing treatment with a mechanical chest compression device (LUCAS 2/3, Jolife AB/Stryker, Lund, Sweden) or continued manual chest compressions. It is intended that recruitment will occur on a 24/7 basis by the clinical cardiac arrest team. The primary study outcome is the proportion of eligible participants randomised in the study during site operational recruitment hours. Participants will be enrolled using a model of deferred consent, with consent for follow-up sought from patients or their consultee in those that survive the cardiac arrest event. The trial will have an embedded qualitative study, in which we will conduct semi-structured interviews with hospital staff to explore facilitators and barriers to study recruitment. Discussion The findings of COMPRESS-RCT will provide important information about the deliverability of an effectiveness trial to evaluate the effect on 30-day mortality of routine use of mechanical chest compression devices in adult in-hospital cardiac arrest patients