Preferred reporting items for overviews of systematic reviews including harms checklist: a pilot tool to be used for balanced reporting of benefits and harms

Konstantinos I Bougioukas; Aris Liakos; Apostolos Tsapas; Evangelia Ntzani; Anna-Bettina Haidich

doi:10.1016/j.jclinepi.2017.10.002

Preferred reporting items for overviews of systematic reviews including harms checklist: a pilot tool to be used for balanced reporting of benefits and harms

J Clin Epidemiol. 2018 Jan:93:9-24. doi: 10.1016/j.jclinepi.2017.10.002. Epub 2017 Oct 14.

Authors

Konstantinos I Bougioukas¹, Aris Liakos², Apostolos Tsapas³, Evangelia Ntzani⁴, Anna-Bettina Haidich⁵

Affiliations

¹ Department of Hygiene and Epidemiology, Medical School, Aristotle University of Thessaloniki, University Campus, 54124 Thessaloniki, Greece.
² Second Medical Department, Clinical Research and Evidence-Based Medicine Unit, Aristotle University of Thessaloniki, Konstantinoupoleos 49, 54642 Thessaloniki, Greece.
³ Second Medical Department, Clinical Research and Evidence-Based Medicine Unit, Aristotle University of Thessaloniki, Konstantinoupoleos 49, 54642 Thessaloniki, Greece; Harris Manchester College, University of Oxford, Mansfield Rd, Oxford, OX1 3TD, UK.
⁴ Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, University Campus, Stavros Niarchos Av., Ioannina, Greece; Center for Evidence Synthesis in Health, Department of Health Services, Policy and Practice, School of Public Health, Brown University, 121 South Main Street, Providence, RI 02903, USA.
⁵ Department of Hygiene and Epidemiology, Medical School, Aristotle University of Thessaloniki, University Campus, 54124 Thessaloniki, Greece. Electronic address: haidich@auth.gr.

PMID: 29037888
DOI: 10.1016/j.jclinepi.2017.10.002

Abstract

Objectives: An overview of systematic reviews (OoSRs) is a study designed to synthesize multiple evidence from existing systematic reviews on a specific domain. The aim of this paper was to offer a pilot version checklist with Preferred Reporting Items for OoSRs (PRIO-harms) to promote a more balanced reporting of benefits and harms in OoSRs of health care interventions.

Study design and setting: The included items were developed by combining key features from health care OoSRs designs with recommendations from statements of other relevant checklists and pertinent methodological review articles. Two raters independently used the PRIO-harms checklist to assess a sample of 20 OoSRs.

Results: The PRIO-harms tool consists of a 27-item (56 (sub-)items in total) checklist and is accompanied by a five-stage process flow diagram (identification, screening, eligibility, inclusion, and separation of relevant studies). The mean interrater reliability (Gwet's AC1 statistic) between reviewers was 0.90 (95% confidence interval: 0.88, 0.92) indicating a very good agreement.

Conclusion: The PRIO-harms tool can be used in every OoSRs that addresses health care interventions. This instrument will assist overview authors to improve completeness and transparency of research reporting with emphasis on harms. However, it might benefit from critical review and further validation from experts and research teams that produce OoSRs.

Keywords: Adverse events; Checklist; Harms; Overview of systematic reviews; Reporting; Umbrella reviews.

Publication types

Review

MeSH terms

Checklist / standards*
Evidence-Based Medicine
Humans
Pilot Projects
Practice Guidelines as Topic
Research Personnel
Research Report / standards*
Systematic Reviews as Topic*