A guide to performing a peer review of randomised controlled trials

Peer review of journal articles is an important step in the research process. Editors rely on the expertise of peer reviewers to properly assess submissions. Yet, peer review quality varies widely and few receive training or guidance in how to approach the task. This paper describes some of the main steps that peer reviewers in general and, in particular, those performing reviewes of randomised controlled trials (RCT), can use when carrying out a review. It can be helpful to begin with a brief read to acquaint yourself with the study, followed by a detailed read and a careful check for flaws. These can be divided into ‘major’ (problems that must be resolved before publication can be considered) and ‘minor’ (suggested improvements that are discretionary) flaws. Being aware of the appropriate reporting checklist for the study being reviewed (such as CONSORT and its extensions for RCTs) can also be valuable. Competing interests or prejudices might corrode the review, so ensuring transparency about them is important. Finally, ensuring that the paper’s strengths are acknowledged along with a dissection of the weaknesses provides balance and perspective to both authors and editors. Helpful reviews are constructive and improve the quality of the paper. The proper conduct of a peer review is the responsibility of all who accept the role

Patients' expectations of the benefits and harms of treatments, screening, and tests a systematic review

IMPORTANCE Unrealistic patient expectations of the benefits and harms of interventions can influence decision making and may be contributing to increasing intervention uptake and health care costs. OBJECTIVE To systematically review all studies that have quantitatively assessed patients' expectations of the benefits and/or harms of any treatment, test, or screening test. EVIDENCE REVIEW A comprehensive search strategy was used in 4 databases (MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, PsycINFO) up to June 2013, with no language or study type restriction.We also ran cited reference searches of included studies and contacted experts and study authors. Two researchers independently evaluated methodological quality and extracted participants' estimates of benefit and harms and authors' contemporaneous estimates. FINDINGS Of the 15 343 records screened, 36 articles (from 35 studies) involving a total of 27 323 patients were eligible. Fourteen studies focused on a screen, 15 on treatment, 3 a test, and 3 on treatment and screening. More studies assessed only benefit expectations (22 [63%]) than benefit and harm expectations (10 [29%]) or only harm (3 [8%]). Fifty-four outcomes (across 32 studies) assessed benefit expectations: of the 34 outcomes with overestimation data available, the majority of participants overestimated benefit for 22 (65%) of them. For 17 benefit expectation outcomes, we could not calculate the proportion of participants who overestimated or underestimated, although for 15 (88%) of these, study authors concluded that participants overestimated benefits. Expectations of harm were assessed by 27 outcomes (across 13 studies): underestimation data were available for 15 outcomes and the majority of participants underestimated harm for 10 (67%) of these. A correct estimation by at least 50% of participants only occurred for 2 outcomes about benefit expectations and 2 outcomes about harm expectations. CONCLUSIONS AND RELEVANCE The majority of participants overestimated intervention benefit and underestimated harm. Clinicians should discuss accurate and balanced information about intervention benefits and harms with patients, providing the opportunity to develop realistic expectations and make informed decisions

Poor description of non-pharmacological interventions:Analysis of consecutive sample of randomised trials

Objectives To evaluate the completeness of descriptions of non-pharmacological interventions in randomised trials, identify which elements are most frequently missing, and assess whether authors can provide missing details. Design Analysis of consecutive sample of randomised trials of non-pharmacological interventions. Data sources and study selection All reports of randomised trials of non-pharmacological interventions published in 2009 in six leading general medical journals; 133 trial reports, with 137 interventions, met the inclusion criteria. Data collection Using an eight item checklist, two raters assessed the primary full trial report, plus any reference materials, appendices, or websites. Questions about missing details were emailed to corresponding authors, and relevant items were then reassessed. Results Of 137 interventions, only 53 (39%) were adequately described; this was increased to 81 (59%) by using 63 responses from 88 contacted authors. The most frequently missing item was the “intervention materials” (47% complete), but it also improved the most after author response (92% complete). Whereas some authors (27/70) provided materials or further information, other authors (21/70) could not; their reasons included copyright or intellectual property concerns, not having the materials or intervention details, or being unaware of their importance. Although 46 (34%) trial interventions had further information or materials readily available on a website, many were not mentioned in the report, were not freely accessible, or the URL was no longer functioning. Conclusions Missing essential information about interventions is a frequent, yet remediable, contributor to the worldwide waste in research funding. If trial reports do not have a sufficient description of interventions, other researchers cannot build on the findings, and clinicians and patients cannot reliably implement useful interventions. Improvement will require action by funders, researchers, and publishers, aided by long term repositories of materials linked to publications

Parents' beliefs and knowledge about the management of acute otitis media: A qualitative study

BACKGROUND: Acute otitis media is a common reason for antibiotic prescribing, despite strong evidence that antibiotics provide minimal benefit. Studies have demonstrated that patients’ (or parents’) expectations of antibiotics often influence general practitioners’ (GPs) decision to prescribe antibiotics, but few have explored parents’ expectations of the management of infections in children, or which factors influence the development of these expectations. This study aimed to explore parents’ knowledge and beliefs about the management of acute otitis media in children. METHODS: Individual semi-structured interviews were conducted with 15 parents of children who had recently presented to their GP with acute otitis media. Parents were recruited at childcare centres or playgroups in Brisbane, Australia. RESULTS: Many parents did not have an accurate understanding of what causes acute otitis media. GPs were primarily consulted for the management of symptoms such as pain and fever. Others specifically wanted reassurance or were concerned about hearing loss. Most parents assumed that antibiotics were the best treatment option. Parents’ perceptions about the best treatment were mainly based on their previous experience and the advice of the GP. Pain relief medications, such as paracetamol and non-steroidal anti-inflammatory drugs, were not considered by parents to be sufficient treatment on their own. CONCLUSION: There is discrepancy between parents’ beliefs and expectations of management of acute otitis media and the evidence-based recommendations. This study provides insights into parents’ expectations of management of acute otitis media, which may help inform clinicians about perceptions and misperceptions that may be valuable to elicit and discuss

Telehealth methods to deliver multifactorial dietary interventions in adults with chronic disease: A systematic review protocol

Background: The long-term management of chronic diseases requires adoption of complex dietary recommendations, which can be facilitated by regular coaching to support sustained behaviour change. Telehealth interventions can overcome patient-centred barriers to accessing face-to-face programs and provide feasible delivery methods, ubiquitous and accessible regardless of geographic location. The protocol for this systematic review explains the methods that will be utilised to answer the review question of whether telehealth interventions are effective at promoting change in dietary intake and improving diet quality in people with chronic disease. Methods/design: A structured search of Medline, EMBASE, CINAHL, and PsychINFO, from their inception, will be conducted. We will consider randomised controlled trials which evaluate complex dietary interventions in adults with chronic disease. Studies must provide diet education in an intervention longer than 4 weeks in duration, and at least half of the intervention contact must be delivered via telehealth. Comparisons will be made against usual care or a non-telehealth intervention. The primary outcome of interest is dietary change with secondary outcomes relating to clinical markers pre-specified in the methodology. The process for selecting studies, extracting data, and resolving conflicts will follow a set protocol. Two authors will independently appraise the studies and extract the data, using specified methods. Meta-analyses will be conducted where appropriate, with parameters for determining statistical heterogeneity pre-specified. The GRADE tool will be used for determining the quality of evidence for analysed outcomes. Discussion: To date, there has been a considerable variability in the strategies used to deliver dietary education, and the overall effectiveness of telehealth dietary interventions for facilitating dietary change has not been reviewed systematically in adults with chronic disease. A systematic synthesis of telehealth strategies will inform the development of evidence-based telehealth programs that can be tailored to deliver dietary interventions specific to chronic disease conditions. Systematic review registration: PROSPERO CRD42015026398

Educational interventions to improve people's understanding of key concepts in assessing the effects of health interventions: a systematic review

Abstract Background Health information is readily accessible but is of variable quality. General knowledge about how to assess whether claims about health interventions are trustworthy is not common, so people’s health decisions can be ill-informed, unnecessarily costly and even unsafe. This review aims to identify and evaluate studies of educational interventions designed to improve people’s understanding of key concepts for evaluating claims about the effects of health interventions. Methods/Design We searched multiple electronic databases and sources of grey literature. Inclusion criteria included all study types that included a comparison, any participants (except health professionals or health professional students) and educational interventions aimed at improving people’s understanding of one or more of the key concepts considered necessary for assessing health intervention claims. Knowledge and/or understanding of concepts or skills relevant to evaluating health information were our primary outcome measures. Secondary outcomes included behaviour, confidence, attitude and satisfaction with the educational interventions. Two authors independently screened search results, assessed study eligibility and risk of bias and extracted data. Results were summarised using descriptive synthesis. Results Among 24 eligible studies, 14 were randomised trials and 10 used other study designs. There was heterogeneity across study participants, settings and educational intervention type, content and delivery. The risk of bias was high in at least one domain for all randomised studies. Most studies measured outcomes immediately after the educational intervention, with few measuring later. In most of the comparisons, measures of knowledge and skills were better among those who had received educational interventions than among controls, and some of these differences were statistically significant. The effects on secondary outcomes were inconsistent. Conclusions Educational interventions to improve people’s understanding of key concepts for evaluating health intervention claims can improve people’s knowledge and skills, at least in the short term. Effects on confidence, attitude and behaviour are uncertain. Many of the studies were at moderate or greater risk of bias. Improvements in study quality, consistency of outcome measures and measures of longer-term effects are needed to improve confidence in estimates of the effects of educational interventions to improve people’s understanding of key concepts for evaluating health intervention claims. Systematic review registration PROSPERO CRD4201603310

Can nudge-interventions address health service overuse and underuse? Protocol for a systematic review

IntroductionNudge-interventions aimed at health professionals are proposed to reduce the overuse and underuse of health services. However, little is known about their effectiveness at changing health professionals’ behaviours in relation to overuse or underuse of tests or treatments.ObjectiveThe aim of this study is to systematically identify and synthesise the studies that have assessed the effect of nudge-interventions aimed at health professionals on the overuse or underuse of health services.Methods and analysisWe will perform a systematic review. All study designs that include a control comparison will be included. Any qualified health professional, across any specialty or setting, will be included. Only nudge-interventions aimed at altering the behaviour of health professionals will be included. We will examine the effect of choice architecture nudges (default options, active choice, framing effects, order effects) and social nudges (accountable justification and pre-commitment or publicly declared pledge/contract). Studies with outcomes relevant to overuse or underuse of health services will be included. Relevant studies will be identified by a computer-aided search of the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, CINAHL, Embase and PsycINFO databases. Two independent reviewers will screen studies for eligibility, extract data and perform the risk of bias assessment using the criteria recommended by the Cochrane Effective Practice and Organisation of Care (EPOC) group. We will report our results in a structured synthesis format, as recommended by the Cochrane EPOC group.Ethics and disseminationNo ethical approval is required for this study. Results will be presented at relevant scientific conferences and in peer-reviewed literature