Exempting low-risk health and medical research from ethics reviews: Comparing Australia, the United Kingdom, the United States and the Netherlands

Background: Disproportionate regulation of health and medical research contributes to research waste. Better understanding of exemptions of research from ethics review in different jurisdictions may help to guide modification of review processes and reduce research waste. Our aim was to identify examples of low-risk human health and medical research exempt from ethics reviews in Australia, the United Kingdom, the United States and the Netherlands. Methods: We examined documents providing national guidance on research ethics in each country, including those authored by the National Health and Medical Research Council (Australia), National Health Service (United Kingdom), the Office for Human Research Protections (United States) and the Central Committee on Research Involving Humans (the Netherlands). Examples and types of research projects exempt from ethics reviews were identified, and similar examples and types were grouped together. Results: Nine categories of research were exempt from ethics reviews across the four countries; these were existing data or specimen, questionnaire or survey, interview, post-marketing study, evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, audit and service evaluation, and other exemptions. Existing non-identifiable data and specimens were exempt in all countries. Four categories - evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, and audit and service evaluation - were exempted by one country each. The remaining categories were exempted by two or three countries. Conclusions: Examples and types of research exempt from research ethics reviews varied considerably. Given the considerable costs and burdens on researchers and ethics committees, it would be worthwhile to develop and provide clearer guidance on exemptions, illustrated with examples, with transparent underpinning rationales

Resistance decay in individuals after antibiotic exposure in primary care: A systematic review and meta-analysis

Abstract Background Antibiotic resistance is an urgent global problem, but reversibility is poorly understood. We examined the development and decay of bacterial resistance in community patients after antibiotic use. Methods This was a systematic review and meta-analysis. PubMed, EMBASE and CENTRAL (from inception to May 2017) were searched, with forward and backward citation searches of the identified studies. We contacted authors whose data were unclear, and of abstract-only reports, for further information. We considered controlled or times-series studies of patients in the community who were given antibiotics and where the subsequent prevalence of resistant bacteria was measured. Two authors extracted risk of bias and data. The meta-analysis used a fixed-effects model. Results Of 24,492 articles screened, five controlled and 20 time-series studies (total 16,353 children and 1461 adults) were eligible. Resistance in Streptococcus pneumoniae initially increased fourfold after penicillin-class antibiotic exposure [odds ratio (OR) 4.2, 95% confidence interval (CI) 3.5–5.4], but this fell after 1 month (OR 1.7, 95% CI 1.3–2.1). After cephalosporin-class antibiotics, resistance increased (OR 2.2, 95%CI 1.7-2.9); and fell to (OR 1.6, 95% CI 1.2-2.3) at 1 month. After macrolide-class antibiotics, resistance increased (OR 3.8, 95% CI 1.9–7.6) and persisted for 1 month (OR 5.2, 95% CI 2.6–10.3) and 3 months (OR 8.1, 95% CI 4.6–14.2, from controlled studies and OR 2.3, 95% CI 0.6–9.4, from time-series studies). Resistance in Haemophilus influenzae after penicillins was not significantly increased (OR 1.3, 95% CI 0.9–1.9) initially but was at 1 month (OR 3.4, 95% CI 1.5–7.6), falling after 3 months (OR 1.0, 95% CI 0.5–2.2). Data were sparse for cephalosporins and macrolides. Resistance in Enterobacter increased post-exposure (OR 3.2, 95% CI 0.9–10.8, from controlled studies and OR 7.1, 95% CI 4.2–12, from time-series studies], but was lower after 1 month (OR 1.8, 95% CI 0.9–3.6). Conclusions Resistance generally increased soon after antibiotic use. For some antibiotic classes and bacteria, it partially diminished after 1 and 3 months, but longer-term data are lacking and urgently needed. Trial registration PROSPERO CRD42015025499

Cochrane acute respiratory infections group's stakeholder engagement project identified systematic review priority areas

Objective: Cochrane acute respiratory infections (ARIs) group conducts systematic reviews of the evidence for treatment and prevention of ARIs. We report the results of a prioritization project, aiming to identify highest priority systematic review topics. Study Design/Setting: The project consisted of two phases. Phase 1 analyzed the gap between existing randomized controlled trials and Cochrane systematic reviews (reported previously). Phase 2 (reported here) consisted of a two-round survey. In round 1, respondents prioritized 68 topics and suggested up to 10 additional topics; in round 2, respondents prioritized top 25 topics from round 1. Results: Respondents included clinicians, researchers, systematic reviewers, allied health, patients, and carers, from 33 different countries. In round 1, 154 respondents identified 20 priority topics, most commonly selecting topics in nonspecific ARIs, influenza, and common cold. Fifty respondents also collectively suggested 134 additional topics. In round 2, 78 respondents prioritized top 25 topics, most commonly in the areas of nonspecific ARIs, pneumonia, and influenza. Conclusion: We generated a list of priority systematic review topics to guide the Cochrane ARI group's systematic review work for the next 24 months. Stakeholder involvement enhanced the transparency of the process and will increase the usability and relevance of the group's work to stakeholders

Q-SEA - a tool for quality assessment of ethics analyses conducted as part of health technology assessments

Introduction: Assessment of ethics issues is an important part of health technology assessments (HTA). However, in terms of existence of quality assessment tools, ethics for HTA is methodologically under-developed in comparison to other areas of HTA, such as clinical or cost effectiveness.Objective: To methodologically advance ethics for HTA by: (1) proposing and elaborating Q-SEA, the first instrument for quality assessment of ethics analyses, and (2) applying Q-SEA to a sample systematic review of ethics for HTA, in order to illustrate and facilitate its use. Methods: To develop a list of items for the Q-SEA instrument, we sys-tematically reviewed the literature on methodology in ethics for HTA, reviewed HTA organizations’ websites, and solicited views from 32 ex-perts in the field of ethics for HTA at two 2-day workshops. We sub-sequently refined Q-SEA through its application to an ethics analysis conducted for HTA.Results: Q-SEA instrument consists of two domains – the process do-main and the output domain. The process domain consists of 5 ele-ments: research question, literature search, inclusion/exclusion criteria, perspective, and ethics framework. The output domain consists of 5 elements: completeness, bias, implications, conceptual clarification, and conflicting values.Conclusion: Q-SEA is the first instrument for quality assessment of ethics analyses in HTA. Further refinements to the instrument to enhance its usability continue

Patient and public involvement in the development of clinical practice guidelines: a scoping review

OBJECTIVES: Organisations that develop clinical practice guidelines (CPGs) encourage involvement of patients and the publics in their development, however, there are no standard methodologies for doing so. To examine how CPGs report patient and public involvement (PPI), we conducted a scoping review of the evidence addressing the following four questions: (1) who are the patients and publics involved in developing the CPG?; (2) from where and how are the patients and publics recruited?; (3) at what stage in the CPG development process are the patients and publics involved? and (4) how do the patients and publics contribute their views? We also extracted data on the use of PPI reporting checklists by the included studies. DESIGN: We used the methodology developed by Arksey and O’Malley and refined by the Joanna Briggs Institute. We searched PubMed, Embase, CINAHL and PsycINFO, websites of national guideline bodies from the UK, Canada, Australia and the USA, and conducted a forward citation search. No language, date or participant demographics restrictions were applied. Data were synthesised narratively. RESULTS: We included 47 studies addressing 1 or more of the 4 questions. All included studies reported who the patient and publics involved (PPI members) were, and several studies reported PPI members from different groups. Patients were reported in 43/47 studies, advocates were reported in 22/47 studies, patients and advocates reported in 17/47 studies, and general public reported in 2/47 studies. Thirty-four studies reported from where the patients and publics were recruited, with patient groups being the most common (20/34). Stage of involvement was reported by 42/47 studies, most commonly at question identification (26/42) and draft review (18/42) stages. Forty-two studies reported how the patients contributed, most commonly via group meetings (18/42) or individual interviews. Ten studies cited or used a reporting checklist to report findings. CONCLUSIONS: Our scoping review has revealed knowledge gaps to inform future research in several ways: replication, terminology and inclusion. First, no standard approach to PPI in CPG development could be inferred from the research. Second, inconsistent terminology to describe patients and publics reduces clarity around which patients and publics have been involved in developing CPGs. Finally, the under-representation of research describing PPI in the development of screening, as opposed to treatment, CPGs warrants further attention