Dataset Information

Are We Improving? Update and Critical Appraisal of the Reporting of Decision Process and Quality Measures in Trials Evaluating Patient Decision Aids.

ABSTRACT:

Background

In 2014, a systematic review found large gaps in the quality of reporting of measures used in 86 published trials evaluating the effectiveness of patient decision aids (PtDAs). The purpose of this study was to update that review.

Methods

We examined measures of decision making used in 49 randomized controlled trials included in the 2014 and 2017 Cochrane Collaboration systematic review of PtDAs. Data on development of the measures, reliability, validity, responsiveness, precision, interpretability, feasibility, and acceptability were independently abstracted by 2 paired reviewers.

Results

Information from 273 measures was abstracted, and 109 of these covered the core domains of decision processes (n = 55) and decision quality including informed choice/knowledge (n = 48) and values-choice concordance (n = 12). Very few studies reported data on the performance and clinical sensibility of measures, with reliability (23%) and validity (6%) being the most common. Studies using new measures were less likely to include information about their psychometric performance compared with previously published measures.

Limitations

The review was limited to reporting of measures in studies included in the Cochrane review and did not consult prior publications.

Conclusion

There continues to be very little reported about the development or performance of measures used to evaluate the effectiveness of PtDAs in published trials. Minimum reporting standards have been published, and efforts to require investigators to use them are needed.

SUBMITTER: Trenaman L

PROVIDER: S-EPMC8474325 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe original version of the International Patient Decision Aid Standards (IPDAS) recommended that patient decision aids (PtDAs) should be carefully developed, user-tested and open to scrutiny, with a well-documented and systematically applied development process. We carried out a review to check the relevance and scope of this quality dimension and, if necessary, to update it.MethodsOur review drew on three sources: a) published papers describing PtDAs evaluated in randomised controlled trials and included in the most recent Cochrane Collaboration review; b) linked papers cited in the trial reports that described how the PtDAs had been developed; and c) papers and web reports outlining the development process used by organisations experienced in developing multiple PtDAs. We then developed an extended model of the development process indicating the various steps on which documentation is required, as well as a checklist to assess the frequency with which each of the elements was publicly reported.ResultsKey features common to all patient decision aid (PtDA) development processes include: scoping and design; development of a prototype; 'alpha' testing with patients and clinicians in an iterative process; 'beta' testing in 'real life' conditions (field tests); and production of a final version for use and/or further evaluation. Only about half of the published reports on the development of PtDAs that we reviewed appear to have been field tested with patients, and even fewer had been reviewed or tested by clinicians not involved in the development process. Very few described a distribution strategy, and surprisingly few (17%) described a method for reviewing and synthesizing the clinical evidence. We describe a model development process that includes all the original elements of the original IPDAS criterion, expanded to include consideration of format and distribution plans as well as prototype development.ConclusionsThe case for including each of the elements outlined in our model development process is pragmatic rather than evidence-based. Optimal methods for ensuring that each stage of the process is carried out effectively require further development and testing.