Evaluating the credibility of anchor based estimates of minimal important differences for patient reported outcomes: instrument development and reliability study

被引：170

作者：

Devji, Tahira ^{[1
]}

Carrasco-Labra, Alonso ^{[1
]}

Qasim, Anila ^{[1
]}

Phillips, Mark ^{[1
]}

Johnston, Bradley C. ^{[1
,2
]}

Devasenapathy, Niveditha ^{[3
]}

Zeraatkar, Dena ^{[1
]}

Bhatt, Meha ^{[1
]}

Jin, Xuejing ^{[4
]}

Brignardello-Petersen, Romina ^{[1
]}

Urquhart, Olivia ^{[5
]}

Foroutan, Farid ^{[1
]}

Schandelmaier, Stefan ^{[1
]}

Pardo-Hernandez, Hector ^{[6
,7
]}

Vernooij, Robin W. M. ^{[8
]}

Huang, Hsiaomin ^{[9
]}

Rizwan, Yamna ^{[10
]}

Siemieniuk, Reed ^{[1
]}

Lytvyn, Lyubov ^{[1
]}

Patrick, Donald L. ^{[11
]}

Ebrahim, Shanil ^{[1
]}

Furukawa, Toshi ^{[12
]}

Nesrallah, Gihad ^{[13
,14
,15
]}

Schunemann, Holger J. ^{[1
,16
]}

Bhandari, Mohit ^{[1
,17
]}

Thabane, Lehana ^{[1
]}

Guyatt, Gordon H. ^{[1
,16
]}

机构：

[1] McMaster Univ, Dept Hlth Res Methods Evidence & Impact, 1280 Main St West, Hamilton, ON L8S 4L8, Canada

[2] Dalhousie Univ, Dept Community Hlth & Epidemiol, Halifax, NS, Canada

[3] Indian Inst Publ Hlth, Publ Hlth Fdn India, Gandhinagar, Gujarat, India

[4] Univ Alberta, Sch Publ Hlth, Edmonton, AB, Canada

[5] Amer Dent Assoc, Ctr Evidence Based Dent, Chicago, IL USA

[6] St Pau Biomed Res Inst IIB St Pau, Iberoamer Cochrane Ctr, Barcelona, Spain

[7] CIBER Epidemiol & Salud Publ CIBERESP, Barcelona, Spain

[8] Comprehens Canc Org, Dept Res, Utrecht, Netherlands

[9] Univ Michigan, Dept Orthoped Surg, Ann Arbor, MI 48109 USA

[10] Univ Guelph, Dept Mol & Cellular Biol, Guelph, ON, Canada

[11] Univ Washington, Dept Hlth Serv, Seattle, WA 98195 USA

[12] Kyoto Univ, Sch Publ Hlth, Dept Hlth Promot & Human Behav, Grad Sch Med, Kyoto, Japan

[13] Humber River Reg Hosp, Nephrol Program, Toronto, ON, Canada

[14] Univ Western Ontario, Div Nephrol, London, ON, Canada

[15] St Michaels Hosp, Li Ka Shing Knowledge Inst, Toronto, ON, Canada

[16] McMaster Univ, Dept Med, Hamilton, ON, Canada

[17] McMaster Univ, Dept Surg, Hamilton, ON, Canada

来源：

BMJ-BRITISH MEDICAL JOURNAL | 2020年 / 369卷

基金：

加拿大健康研究院;

关键词：

QUALITY-OF-LIFE; CLINICALLY IMPORTANT DIFFERENCE; OPERATING CHARACTERISTIC ANALYSIS; HEALTH-STATUS MEASURES; SELF-RATED HEALTH; MEANINGFUL CHANGE; RESPONSIVENESS; QUESTIONNAIRE; VALIDITY; TRIALS;

D O I：

10.1136/bmj.m1714

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

OBJECTIVE To develop an instrument to evaluate the credibility of anchor based minimal important differences (MIDs) for outcome measures reported by patients, and to assess the reliability of the instrument. DESIGN Instrument development and reliability study. DATA SOURCES Initial criteria were developed for evaluating the credibility of anchor based MIDs based on a literature review (Medline, Embase, CINAHL, and Psyclnfo databases) and the experience of the authors in the methodology for estimation of MIDs. Iterative discussions by the team and pilot testing with experts and potential users facilitated the development of the final instrument. PARTICIPANTS With the newly developed instrument, pairs of masters, doctoral, or postdoctoral students with a background in health research methodology independently evaluated the credibility of a sample of MID estimates. MAIN OUTCOME MEASURES Core credibility criteria applicable to all anchor types, additional criteria for transition rating anchors, and inter-rater reliability coefficients were determined. RESULTS The credibility instrument has five core criteria: the anchor is rated by the patient; the anchor is interpretable and relevant to the patient; the MID estimate is precise; the correlation between the anchor and the outcome measure reported by the patient is satisfactory; and the authors select a threshold on the anchor that reflects a small but important difference. The additional criteria for transition rating anchors are: the time elapsed between baseline and follow-up measurement for estimation of the MID is optimal; and the correlations of the transition rating with the baseline, follow-up, and change score in the patient reported outcome measures are satisfactory. Inter-rater reliability coefficients (K) for the core criteria and for one item from the additional criteria ranged from 0.70 to 0.94. Reporting issues prevented the evaluation of the reliability of the three other additional criteria for the transition rating anchors. CONCLUSIONS Researchers, clinicians, and healthcare policy decision makers can consider using this instrument to evaluate the design, conduct, and analysis of studies estimating anchor based minimal important differences.

引用

页数：11

共 98 条

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