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Objectives: Minimal important difference (MID), the smallest change or difference that patients perceive as important, aids interpretation of change in patient-reported outcome measure (PROM) scores. A credibility instrument that assesses the methodological rigor of an anchor-based MID includes one core item addressing the correlation between the PROM and the anchor. However, the majority of MID studies in the literature fail to report the correlation. To address this issue, we extended the anchor-based MID credibility instrument by adding an item addressing construct proximity as an alternative to the correlation item., Study Design and Setting: Informed by an MID methodological survey, we added an alternative item-a subjective assessment of similarity of the constructs (i.e., construct proximity) between PROM and anchor-to the correlation item and generated principles for the assessment. We sampled 101 MIDs and analyzed the assessments performed by each pair of raters. By calculating weighted Cohen's kappa, we assessed the reliability of the assessments., Results: Construct proximity assessment is based on the anticipated association between the anchor and PROM constructs: the closer the anticipated association, the higher the rating. Our detailed principles address the most frequently used anchors: transition ratings, measures of satisfaction, other PROMs, and clinical measures. The assessments showed acceptable agreement (weighted kappa 0.74, 95% CI 0.55-0.94) between raters., Conclusion: In the absence of a reported correlation coefficient, construct proximity assessment provides a useful alternative in the credibility assessment of anchor-based MID estimates., (Copyright © 2023 Elsevier Inc. All rights reserved.)

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., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objective: To systematically survey the literature addressing the reporting of studies estimating anchor-based minimal important differences (MIDs) and choice of optimal MIDs., Study Design and Setting: We searched Medline, Embase and PsycINFO from 1987 to March 2020. Teams of two reviewers independently identified eligible publications and extracted quotations addressing relevant issues for reporting and/or selecting anchor-based MIDs. Using a coding list, we assigned the same code to quotations capturing similar or related issues. For each code, we generated an 'item', i.e., a specific phrase or sentence capturing the underlying concept. When multiple concepts existed under a single code, the team created multiple items for that code. We clustered codes addressing a broader methodological issue into a 'category' and classified items as relevant for reporting, relevant for selecting an anchor-based MID, or both., Results: We identified 136 eligible publications that provided 6 categories (MID definition, anchors, patient-reported outcome measures, generalizability and statistics) and 24 codes. These codes contained 34 items related to reporting MID studies, of which 29 were also related to selecting MIDs., Conclusion: The systematic survey identified items related to reporting of anchor-based MID studies and selecting optimal MIDs. These provide a conceptual framework to inform the design of studies related to MIDs, and a basis for developing a reporting standard and a selection approach for MIDs., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Cough severity represents an important subjective endpoint in assessing the effectiveness of therapies for patients with chronic cough. Although cough-specific quality of life questionnaires exist, a widely available cough severity instrument with established measurement properties remains unavailable., Aims: To identify and summarise the results of studies reporting on the experience of patients with chronic cough and, in the process, develop a conceptual framework to inform development of a patient-reported outcome measurement (PROM) addressing cough severity., Results: We identified 61 eligible studies reporting on patient experience with chronic cough. Studies provided 82 potential items, of which 43 proved unique and relevant to cough severity. The urge-to-cough sensation and the cough symptom itself represented broad domains of cough severity. Two subdomains under urge-to-cough included frequency (1 item) and intensity (1 item). Five subdomains under cough symptoms included control (2 items), frequency (6 items), bout duration (1 item), intensity (8 items), and associated features/sequelae (24 items)., Conclusions: Our systematic survey and conceptual framework identified items and domains of cough severity in patients with refractory or unexplained chronic cough. The results support item generation and content validity for a PROM assessing cough severity., Competing Interests: Conflict of interest: E. Kum has nothing to disclose. Conflict of interest: G.H. Guyatt has nothing to disclose. Conflict of interest: T. Devji has nothing to disclose. Conflict of interest: Y. Wang has nothing to disclose. Conflict of interest: L. Bakaa has nothing to disclose. Conflict of interest: L. Lan has nothing to disclose. Conflict of interest: E. Liu has nothing to disclose. Conflict of interest: A. Mastrolonardo has nothing to disclose. Conflict of interest: R. Couban has nothing to disclose. Conflict of interest: P.M. O'Byrne reports grants and personal fees from AstraZeneca and Medimmune, personal fees from GSK and Chiesi, and grants from Novartis, outside the submitted work. Conflict of interest: I. Satia reports personal fees from Educational Talks for GPs, GSK and AstraZeneca, grants from ERS Respire 3 Marie Curie Fellowship and E. J. Moran Campbell Early Career Award, and grants and personal fees from Merck Canada, outside the submitted work., (Copyright ©The authors 2021.)

Objective: Clinical trialists, meta-analysts and clinical guideline developers are increasingly using minimal important differences (MIDs) to enhance the interpretability of patient-reported outcome measures (PROMs). Here, we elucidate three critical issues of which MID users should be aware. Improved understanding of MID concepts and awareness of common pitfalls in methodology and reporting will better inform the application of MIDs in clinical research and decision-making., Methods: We conducted a systematic review to inform the development of an inventory of anchor-based MID estimates for PROMs. We searched four electronic databases to identify primary studies empirically calculating an anchor-based MID estimate for any PROM in adolescent or adult populations across all clinical areas. Our findings are based on information from 338 studies reporting 3389 MIDs for 358 PROMs published between 1989 and 2015., Results: We identified three key issues in the MID literature that demand attention. (1) The profusion of terms representing the MID concept adds unnecessary complexity to users' task in identifying relevant MIDs, requiring meticulous inspection of methodology to ensure estimates offered truly reflect the MID. (2) A multitude of diverse methods for MID estimation that will yield different estimates exist, and whether there are superior options remains unresolved. (3) There are serious issues of incomplete presentation and reporting of key aspects of the design, methodology and results of studies providing anchor-based MIDs, which threatens the optimal use of these estimates for interpretation of intervention effects on PROMs., Conclusions: Although the MID represents a powerful tool for enhancing the interpretability of PROMs, realising its full value will require improved understanding and reporting of its measurement fundamentals., Competing Interests: Competing interests: No, there are no competing interests., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To identify credible anchor-based minimal important differences (MIDs) for patient-reported outcome measures (PROMs) relevant to a BMJ Rapid Recommendations addressing subacromial decompression surgery for shoulder pain., Design: Systematic review., Outcome Measures: Estimates of anchor-based MIDs, and their credibility, for PROMs judged by the parallel BMJ Rapid Recommendations panel as important for informing their recommendation (pain, function and health-related quality of life (HRQoL))., Data Sources: MEDLINE, EMBASE and PsycINFO up to August 2018., Study Selection and Review Methods: We included original studies of any intervention for shoulder conditions reporting estimates of anchor-based MIDs for relevant PROMs. Two reviewers independently evaluated potentially eligible studies according to predefined selection criteria. Six reviewers, working in pairs, independently extracted data from eligible studies using a predesigned, standardised, pilot-tested extraction form and independently assessed the credibility of included studies using an MID credibility tool., Results: We identified 22 studies involving 5562 patients that reported 74 empirically estimated anchor-based MIDs for 10 candidate instruments to assess shoulder pain, function and HRQoL. We identified MIDs of high credibility for pain and function outcomes and of low credibility for HRQoL. We offered median estimates for the systematic review team who applied these MIDs in Grading of Recommendations Assessment, Development and Evaluation (GRADE) evidence summaries and in their interpretations of results in the linked systematic review addressing the effectiveness of surgery for shoulder pain., Conclusions: Our review provides anchor-based MID estimates, as well as a rating of their credibility, for PROMs for patients with shoulder conditions. The MID estimates inform the interpretation for a linked systematic review and guideline addressing subacromial decompression surgery for shoulder pain, and could also prove useful for authors addressing other interventions for shoulder problems., Prospero Registration Number: CRD42018106531., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To identify the most credible anchor-based minimal important differences (MIDs) for patient important outcomes in patients with degenerative knee disease, and to inform BMJ Rapid Recommendations for arthroscopic surgery versus conservative management DESIGN: Systematic review., Outcome Measures: Estimates of anchor-based MIDs, and their credibility, for knee symptoms and health-related quality of life (HRQoL)., Data Sources: MEDLINE, EMBASE and PsycINFO., Eligibility Criteria: We included original studies documenting the development of anchor-based MIDs for patient-reported outcomes (PROs) reported in randomised controlled trials included in the linked systematic review and meta-analysis and judged by the parallel BMJ Rapid Recommendations panel as critically important for informing their recommendation: measures of pain, function and HRQoL., Results: 13 studies reported 95 empirically estimated anchor-based MIDs for 8 PRO instruments and/or their subdomains that measure knee pain, function or HRQoL. All studies used a transition rating (global rating of change) as the anchor to ascertain the MID. Among PROs with more than 1 estimated MID, we found wide variation in MID values. Many studies suffered from serious methodological limitations. We identified the following most credible MIDs: Western Ontario and McMaster University Osteoarthritis Index (WOMAC; pain: 12, function: 13), Knee injury and Osteoarthritis Outcome Score (KOOS; pain: 12, activities of daily living: 8) and EuroQol five dimensions Questionnaire (EQ-5D; 0.15)., Conclusions: We were able to distinguish between more and less credible MID estimates and provide best estimates for key instruments that informed evidence presentation in the associated systematic review and judgements made by the Rapid Recommendation panel., Trial Registration Number: CRD42016047912., Competing Interests: Competing interests: None declared., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)