Standards for Protocol development

Intervention Trials

The protocol of a clinical trial is essential for study conduct, review, reporting, and interpretation. SPIRIT (Standard Protocol Items: Recommendations for Intervention Trials) is an international initiative that aims to improve the quality of clinical trial protocols by defining an evidence-based set of items to address in a protocol.

Systematic Reviews

Systematic reviews should build on a protocol that describes the rationale, hypothesis, and planned methods of the review. Detailed, well-described protocols can facilitate the understanding and appraisal of the review methods, as well as the detection of modifications to methods and selective reporting in completed reviews. PRISMA-P (the Preferred Reporting Items for Systematic reviews and Meta-Analyses for Protocols) consists of a 17-item checklist intended to facilitate the preparation and reporting of a robust protocol for the systematic review.

Standards for conducting systematic reviews

IOM Standards for Systematic Reviews

These standards are for systematic reviews of comparative effectiveness research of therapeutic medical or surgical interventions. Read the Standards for Systematic Reviews

Cochrane Handbook for Systematic Reviews of Interventions

The Cochrane Handbook for Systematic Reviews of Interventions (the Handbook) provides guidance to authors for the preparation of Cochrane Intervention reviews (including Cochrane Overviews of reviews). The Handbook is updated regularly to reflect advances in systematic review methodology and in response to feedback from users.

CRD’s guidance for undertaking reviews in health care

The methods and steps necessary to conduct a systematic review are presented in a core chapter (Chapter 1). Additional issues specific to reviews in more specialised topic areas are addressed in separate, complementary chapters: clinical tests (diagnostic, screening and prognostic) (Chapter 2), public health (Chapter 3), questions relating to harm (Chapter 4) costs (Chapter 5) and how and why interventions work (Chapter 6). This guide focuses on the methods relating to use of aggregate study level data. Individual patient data (IPD) metaanalysis, which is a specific method of systematic review, is discussed briefly in relevant sections. Download the CRD’s guidance for undertaking reviews in health care

Standards for reporting research

The CONSORT 2010 statement is used worldwide to improve the reporting of randomized controlled trials. Here is the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience.

STAndards for the Reporting of Diagnostic accuracy studies (STARD) – The STARD statement consists of a checklist and recommends the use of a flow diagram which describe the design of the study and the flow of patients. Read more

Guidelines for reporting observational studies: The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement.

PRISMA stands for Preferred Reporting Items for Systematic Reviews and Meta-Analyses. It is an evidence-based minimum set of items for reporting in systematic reviews and meta-analyses.