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Testing the face validity and inter-rater agreement of a simple approach to drug-drug interaction evidence assessment.

ABSTRACT: Low concordance between drug-drug interaction (DDI) knowledge bases is a well-documented concern. One potential cause of inconsistency is variability between drug experts in approach to assessing evidence about potential DDIs. In this study, we examined the face validity and inter-rater reliability of a novel DDI evidence evaluation instrument designed to be simple and easy to use.

Methods

A convenience sample of participants with professional experience evaluating DDI evidence was recruited. Participants independently evaluated pre-selected evidence items for 5 drug pairs using the new instrument. For each drug pair, participants labeled each evidence item as sufficient or insufficient to establish the existence of a DDI based on the evidence categories provided by the instrument. Participants also decided if the overall body of evidence supported a DDI involving the drug pair. Agreement was computed both at the evidence item and drug pair levels. A cut-off of ? 70% was chosen as the agreement threshold for percent agreement, while a coefficient > 0.6 was used as the cut-off for chance-corrected agreement. Open ended comments were collected and coded to identify themes related to the participants' experience using the novel approach.

Results

The face validity of the new instrument was established by two rounds of evaluation involving a total of 6 experts. Fifteen experts agreed to participate in the reliability assessment, and 14 completed the study. Participant agreement on the sufficiency of 22 of the 34 evidence items (65%) did not exceed the a priori agreement threshold. Similarly, agreement on the sufficiency of evidence for 3 of the 5 drug pairs (60%) was poor. Chance-corrected agreement at the drug pair level further confirmed the poor interrater reliability of the instrument (Gwet's AC₁ = 0.24, Conger's Kappa = 0.24). Participant comments suggested several possible reasons for the disagreements including unaddressed subjectivity in assessing an evidence item's type and study design, an infeasible separation of evidence evaluation from the consideration of clinical relevance, and potential issues related to the evaluation of DDI case reports.

Conclusions

Even though the key findings were negative, the study's results shed light on how experts approach DDI evidence assessment, including the importance situating evidence assessment within the context of consideration of clinical relevance. Analysis of participant comments within the context of the negative findings identified several promising future research directions including: novel computer-based support for evidence assessment; formal evaluation of a more comprehensive evidence assessment approach that requires consideration of specific, explicitly stated, clinical consequences; and more formal investigation of DDI case report assessment instruments.

SUBMITTER: Grizzle AJ

PROVIDER: S-EPMC7537787 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Publications

Testing the face validity and inter-rater agreement of a simple approach to drug-drug interaction evidence assessment.

Grizzle Amy J AJ Hines Lisa E LE Malone Daniel C DC Kravchenko Olga O Hochheiser Harry H Boyce Richard D RD

Journal of biomedical informatics 20191212

Low concordance between drug-drug interaction (DDI) knowledge bases is a well-documented concern. One potential cause of inconsistency is variability between drug experts in approach to assessing evidence about potential DDIs. In this study, we examined the face validity and inter-rater reliability of a novel DDI evidence evaluation instrument designed to be simple and easy to use.<h4>Methods</h4>A convenience sample of participants with professional experience evaluating DDI evidence was recrui ...[more]

PMID: 31838211

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Project description:Objectives To explore agreement among healthcare professionals assessing eligibility for work disability benefits.Design Systematic review and narrative synthesis of reproducibility studies.Data sources Medline, Embase, and PsycINFO searched up to 16 March 2016, without language restrictions, and review of bibliographies of included studies.Eligibility criteria Observational studies investigating reproducibility among healthcare professionals performing disability evaluations using a global rating of working capacity and reporting inter-rater reliability by a statistical measure or descriptively. Studies could be conducted in insurance settings, where decisions on ability to work include normative judgments based on legal considerations, or in research settings, where decisions on ability to work disregard normative considerations. : Teams of paired reviewers identified eligible studies, appraised their methodological quality and generalisability, and abstracted results with pretested forms. As heterogeneity of research designs and findings impeded a quantitative analysis, a descriptive synthesis stratified by setting (insurance or research) was performed.Results From 4562 references, 101 full text articles were reviewed. Of these, 16 studies conducted in an insurance setting and seven in a research setting, performed in 12 countries, met the inclusion criteria. Studies in the insurance setting were conducted with medical experts assessing claimants who were actual disability claimants or played by actors, hypothetical cases, or short written scenarios. Conditions were mental (n=6, 38%), musculoskeletal (n=4, 25%), or mixed (n=6, 38%). Applicability of findings from studies conducted in an insurance setting to real life evaluations ranged from generalisable (n=7, 44%) and probably generalisable (n=3, 19%) to probably not generalisable (n=6, 37%). Median inter-rater reliability among experts was 0.45 (range intraclass correlation coefficient 0.86 to κ-0.10). Inter-rater reliability was poor in six studies (37%) and excellent in only two (13%). This contrasts with studies conducted in the research setting, where the median inter-rater reliability was 0.76 (range 0.91-0.53), and 71% (5/7) studies achieved excellent inter-rater reliability. Reliability between assessing professionals was higher when the evaluation was guided by a standardised instrument (23 studies, P=0.006). No such association was detected for subjective or chronic health conditions or the studies' generalisability to real world evaluation of disability (P=0.46, 0.45, and 0.65, respectively).Conclusions Despite their common use and far reaching consequences for workers claiming disabling injury or illness, research on the reliability of medical evaluations of disability for work is limited and indicates high variation in judgments among assessing professionals. Standardising the evaluation process could improve reliability. Development and testing of instruments and structured approaches to improve reliability in evaluation of disability are urgently needed.

Project description:Objectives: It has been recommended that clinical trials of Traditional Chinese Medicine (TCM) would be more ecologically valid if its characteristic mode of diagnostic reasoning were integrated into their design. In that context, however, it is also widely held that demonstrating a high level of agreement on initial TCM diagnoses is necessary for the replicability that the biomedical paradigm requires for the conclusions from such trials. Our aim was to review, summarize, and critique quantitative experimental studies of inter-rater agreement in TCM, and some of their underlying assumptions. Design: Systematic electronic searches were conducted for articles that reported a quantitative measure of inter-rater agreement across a number of rating choices based on examinations of human subjects in person by TCM practitioners, and published in English language peer-reviewed journals. Publications in languages other than English were not included, nor those appearing in other than peer-reviewed journals. Predefined categories of information were extracted from full texts by two investigators working independently. Each article was scored for methodological quality. Outcome measures: Design features across all studies and levels of inter-rater agreement across studies that reported the same type of outcome statistic were compared. Results: Twenty-one articles met inclusion criteria. Fourteen assessed inter-rater agreement on TCM diagnoses, two on diagnostic signs found upon traditional TCM examination, and five on novel rating schemes derived from TCM theory and practice. Raters were students of TCM colleges or graduates of TCM training programs with 3 or more years experience and licensure. Type of outcome statistic varied. Mean rates of pairwise agreement averaged 57% (median 65, range 19-96) across the 9 studies reporting them. Mean Cohen's kappa averaged 0.34 (median 0.34, range 0.07-0.59) across the seven studies reporting them. Meta-analysis was not possible due to variations in study design and outcome statistics. High risks of bias and confounding, and deficits in statistical reporting were common. Conclusions: With a few exceptions, the levels of agreement were low to moderate. Most studies had significant deficits of both methodology and reporting. Results overall suggest a few design features that might contribute to higher levels of agreement. These should be studied further with better experimental controls and more thorough reporting of outcomes. In addition, methods of complex systems analysis should be explored to more adequately model the relationship between clinical outcomes, and the series of diagnoses and treatments that are the norm in actual TCM practice.

Dataset Information

Testing the face validity and inter-rater agreement of a simple approach to drug-drug interaction evidence assessment.

Methods

Results

Conclusions

Publications

Testing the face validity and inter-rater agreement of a simple approach to drug-drug interaction evidence assessment.

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