Serious reporting deficiencies exist in minimal important difference studies: current state and suggestions for improvement

Alonso Carrasco-Labra; Tahira Devji; Anila Qasim; Mark Phillips; Bradley C Johnston; Niveditha Devasenapathy; Dena Zeraatkar; Meha Bhatt; Xuejing Jin; Romina Brignardello-Petersen; Olivia Urquhart; Farid Foroutan; Stefan Schandelmaier; Hector Pardo-Hernandez; Robin Wm Vernooij; Hsiaomin Huang; Yamna Rizwan; Reed Siemieniuk; Lyubov Lytvyn; Donald L Patrick; Shanil Ebrahim; Toshi A Furukawa; Gihad Nesrallah; Holger J Schunemann; Mohit Bhandari; Lehana Thabane; Gordon H Guyatt

doi:10.1016/j.jclinepi.2022.06.010

Serious reporting deficiencies exist in minimal important difference studies: current state and suggestions for improvement

J Clin Epidemiol. 2022 Oct:150:25-32. doi: 10.1016/j.jclinepi.2022.06.010. Epub 2022 Jun 24.

Authors

Alonso Carrasco-Labra¹, Tahira Devji², Anila Qasim², Mark Phillips², Bradley C Johnston³, Niveditha Devasenapathy⁴, Dena Zeraatkar², Meha Bhatt², Xuejing Jin⁵, Romina Brignardello-Petersen², Olivia Urquhart⁶, Farid Foroutan², Stefan Schandelmaier², Hector Pardo-Hernandez⁷, Robin Wm Vernooij⁸, Hsiaomin Huang⁹, Yamna Rizwan¹⁰, Reed Siemieniuk², Lyubov Lytvyn², Donald L Patrick¹¹, Shanil Ebrahim², Toshi A Furukawa¹², Gihad Nesrallah¹³, Holger J Schunemann¹⁴, Mohit Bhandari¹⁵, Lehana Thabane², Gordon H Guyatt¹⁴

Affiliations

¹ Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main St East, Hamilton, Ontario, Canada L8S 4L8; Center for Integrative Global Oral Health, University of Pennsylvania, School of Dental Medicine, 240 S. 40th Street, 3rd Fl East, Philadelphia, PA 19104, USA. Electronic address: carrascl@upenn.edu.
² Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main St East, Hamilton, Ontario, Canada L8S 4L8.
³ Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main St East, Hamilton, Ontario, Canada L8S 4L8; Departments of Nutrition, Epidemiology and Biostatistics, Texas A&M University, 373 Olsen Blvd, Cater-Mattil Building, College Station, TX 77843, USA.
⁴ Indian Institute of Public Health, Delhi, Public Health Foundation of India, Plot No. 47, Sector 44, Institutional Area Gurgaon, Haryana 122002, India.
⁵ School of Public Health, University of Alberta, Edmonton, Alberta, 85 Ave, Edmonton, AB T6G 2R3, Canada.
⁶ Evidence Synthesis and Translation Research, Science and Research Institute, American Dental Association, 211 E Chicago Avenue, Chicago, IL, USA.
⁷ Iberoamerican Cochrane Centre; Biomedical Research Institute (IIB Sant Pau); CIBERESP, Hospital de la Santa Creu i Sant Pau, C/ Sant Antoni M. Claret 167 Pavelló 18 planta 0, 08025 Barcelona, Spain.
⁸ Department of Nephrology & Hypertension, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands.
⁹ Department of Orthopaedic Surgery, University of Michigan, 1500 E Medical Center Dr, Ann Arbor, MI 48109, USA.
¹⁰ Department of Molecular and Cellular Biology, University of Guelph, 50 Stone Rd E, Guelph, ON N1G 2W1, Canada.
¹¹ Department of Health Services, University of Washington, 1705 NE Pacific St, Seattle, WA 98195, USA.
¹² Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Yoshidakonoecho, Sakyo Ward, Kyoto 606-8315, Japan.
¹³ Nephrology Program, Humber River Regional Hospital, 1235 Wilson Ave, Toronto, ON M3M 0B2, Canada.
¹⁴ Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main St East, Hamilton, Ontario, Canada L8S 4L8; Department of Medicine, McMaster University, 1280 Main St East, Hamilton L8S 4L8, Canada.
¹⁵ Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main St East, Hamilton, Ontario, Canada L8S 4L8; Department of Surgery, McMaster University, 1280 Main St East, Hamilton L8S 4L8, Canada.

PMID: 35760237
DOI: 10.1016/j.jclinepi.2022.06.010

Abstract

Background and objectives: To evaluate reporting of minimal important difference (MID) estimates using anchor-based methods for patient-reported outcome measures (PROMs), and the association with reporting deficiencies on their credibility.

Methods: Systematic survey of primary studies empirically estimating MIDs. We searched Medline, EMBASE, PsycINFO, and the Patient-Reported Outcome and Quality of Life Instruments Database until October 2018. We evaluated study reporting, focusing on participants' demographics, intervention(s), characteristics of PROMs and anchors, and MID estimation method(s). We assessed the impact of reporting issues on credibility of MID estimates.

Results: In 585 studies reporting on 5,324 MID estimates for 526 distinct PROMs, authors frequently failed to adequately report key characteristics of PROMs and MIDs, including minimum and maximum values of PROM scale, measure of variability accompanying the MID estimate and number of participants included in the MID calculation. Across MID estimates (n = 5,324), the most serious reporting issues impacting credibility included infrequent reporting of the correlation between the anchor and PROM (66%), inadequate details to judge precision of MID point estimate (13%), and insufficient information about the threshold used to ascertain MIDs (16%).

Conclusion: Serious issues of incomplete reporting in the MID literature threaten the optimal use of MID estimates to inform the magnitude of effects of interventions on PROMs.

Keywords: Anchor-based methods; Credibility; Minimal important difference; Patient-reported outcome; Reporting quality; Systematic survey.

Publication types

Review
Research Support, Non-U.S. Gov't

MeSH terms

Humans
Patient Reported Outcome Measures*
Quality of Life*
Surveys and Questionnaires

Grants and funding

DC0190SR/CIHR/Canada