TIDieR: Improving Interventions Reporting & Replication - Essay Sample

Abstract

Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face to face panel meeting. The resultant 12 item TIDieR checklist (brief name, why, what (materials), what (procedure), who provided, how, where, when and how much, tailoring, modifications, how well (planned), how well (actual)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with an explanation and elaboration for each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.

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Introduction

The evaluation of interventions is a major research activity, yet the quality of descriptions of interventions in publications remains remarkably poor. Without a complete published description of the intervention, other researchers cannot replicate or build on research findings. For effective interventions, clinicians, patients, and other decision makers are left unclear about how to reliably implement the intervention. Intervention description involves more than providing a label or the ingredients list. Key features-including duration, dose or intensity, mode of delivery, essential processes, and monitoring-can all influence efficacy and replicability but are often missing or poorly described. For complex interventions, this detail is needed for each component of the intervention. For example, a recent analysis found that only 11% of 262 trials of cancer chemotherapy provided complete details of the trial treatments.1 The most frequently missing elements were dose adjustment and "premedications," but 16% of trials omitted even the route of drug administration. The completeness of intervention description is often worse for non-pharmacological interventions: one analysis of trials and reviews found that 67% of descriptions of drug interventions were adequate compared with only 29% of non-pharmacological interventions.2 A recent study of 137 interventions, from 133 trials of non-drug interventions, found that only 39% of interventions were described adequately in the primary paper or any references, appendices, or websites.3 This increased, albeit to only 59%, by contacting authors for additional information-a task almost no clinicians and few researchers have time to undertake.

The Consolidated Standards of Reporting Trials (CONSORT) 2010 statement4 currently suggests in item 5 that authors should report on "The interventions for each group with sufficient details to allow replication, including how and when they were actually administered." This is appropriate advice, but further guidance seems to be needed: despite endorsement of the CONSORT statement by many journals, reporting of interventions is deficient. The problem arises partly from lack of awareness among authors about what comprises a good description and partly from lack of attention by peer reviewers and editors.5A small number of CONSORT extension statements contain expanded guidance about describing interventions, such as non-pharmacological interventions,6 and specific categories of interventions, such as acupuncture and herbal interventions.7 8 The guidance for content of trial protocols, SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials), provides some recommendations for describing interventions in protocols.9 More generic and comprehensive guidance is needed along with robust ways to implement such guidance. We developed an extension of item 5 of the CONSORT 2010 statement and item 11 of the SPIRIT 2013 statement in the form of a checklist and guidance entitled TIDieR (Template for Intervention Description and Replication), with the objective of improving the completeness of reporting, and ultimately the replicability, of interventions. This article describes the methods used to develop and obtain consensus for this checklist and, for each item, provides an explanation, elaboration, and examples of good reporting. While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs, such as trials, case-control studies, and cohort studies.

Methods for Development of the TIDieR Checklist and Guide

Development of the checklist followed the methodological framework for developing reporting guidelines suggested by the EQUATOR Network.10 In collaboration with the CONSORT steering group, we established a TIDieR steering committee (PPG, TCH, IB, RM, RP). The committee generated a list of 34 potential items from relevant CONSORT checklists and checklists for reporting discipline-specific or particular categories of interventions. The group also reviewed other sources of guidance on intervention reporting identified from a thorough search of the literature, followed by a forward and backward citation search (see appendix 1).

We then used a two round modified Delphi consensus survey method11 involving a broad range of expertise and stakeholders. In the first round, each of the 34 items generated by the steering committee was rated by survey participants as "omit," "possible," "desirable," or "essential" to include in the final checklist. From the first round, some items were reworded and combined, and then the ranked items were divided into three groups for the second round. The first group contained 13 items with the highest rankings (rated as "essential" by 70% participants or "essential or desirable" by 85%), and participants were advised that these would be included in the checklist unless strong objection to their inclusion was received in the second round. The second group contained 13 items with moderate rankings ("essential or desirable" by 65%); participants were asked to rate each of these again as "omit," "possible," "desirable," or "essential." The third group contained three items with low rankings, and participants were advised that these items would be removed unless strong objection to their omission was received in the second round. In both rounds, participants could also suggest additional items, comment on item wording, or provide general comments.

Delphi participants (n=125) were authors of research on describing interventions, clinicians, authors of existing reporting guidelines, clinical trialists, methodologists or statisticians with expertise in clinical trials, and journal editors (see appendix 2). They were invited by email to complete the two rounds of the web based survey. The response rate was 72% (n=90) for the first round. Only those who completed round one and were willing to participate in round two were invited to participate in round two. The response rate for round two was 86% (74 of 86 invited).

After the two Delphi rounds, 13 items were included in the draft checklist, and 13 moderately rated items were retained for further discussion at the in person meeting. The results of the Delphi survey were reported at a two day consensus meeting on 27-28 March 2013, in Oxford, UK. Thirteen invited experts, representing a range of health disciplines (see author list) and with expertise in the development of trial, methodological, and/or reporting guidelines, attended and are all authors of this paper. The meeting began with a review of the literature on intervention reporting, followed by a report of the Delphi process, the draft checklist of 13 items, and rankings of and comments about the additional 13 moderately rated items. Meeting participants discussed the proposed items and agreed which should be included and the wording of each item.

After the meeting, the checklist was distributed to the participants to ensure it reflected the decisions made, and this explanation and elaboration document was drafted. This was then piloted with 26 researchers who were authoring papers of intervention studies and minor clarifications were made in the elaboration of some items.

Scope of the TIDier Checklist and Guide for Describing Interventions

The overarching purpose of the TIDieR checklist is to prompt authors to describe interventions in sufficient detail to allow their replication. The checklist contains the minimum recommended items for describing an intervention. Authors should provide additional information where they consider it necessary for the replication of an intervention.

Most TIDieR items are relevant for most interventions and applicable to even apparently simple drug interventions, which are sometimes poorly described.2 If we consider the elements of an evaluation of an intervention-the population, intervention...