Methods for interpreting change over time in patient-reported outcome measures

Wyrwich, Kathleen W.; Norquist, Josephine M.; Lenderking, William R.; Acaster, Sarah

doi:10.1007/s11136-012-0175-x

Cited by 185 publications

(162 citation statements)

References 43 publications

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“…MCIDs were calculated separately for KOOS and SF12v2 PCS as half the SD of all change scores for that specific PROM [30]. Anchor-based methods require a separate subjective assessment measure of a patient's perceived benefit from an intervention, data not collected by our institution's joint replacement registry [47]. The calculated MCID value was 10 for the KOOS and 5 for the SF12v2 PCS (Table 2).…”

Section: Methodsmentioning

confidence: 99%

Can Preoperative Patient-reported Outcome Measures Be Used to Predict Meaningful Improvement in Function After TKA?

Berliner

Brodke

Chan

et al. 2017

Clinical Orthopaedics &Amp; Related Research

230

181

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Background Despite the overall effectiveness of total knee arthroplasty (TKA), a subset of patients do not experience expected improvements in pain, physical function, and quality of life as documented by patient-reported outcome measures (PROMs), which assess a patient's physical and emotional health and pain. It is therefore important to develop preoperative tools capable of identifying patients unlikely to improve by a clinically important margin after surgery.Questions/purposes The purpose of this study was to determine if an association exists between preoperative PROM scores and patients' likelihood of experiencing a clinically meaningful change in function 1 year after TKA. Methods A retrospective study design was used to evaluate preoperative and 1-year postoperative Knee injury and Osteoarthritis Outcome Score (KOOS) and SF-12 version 2 (SF12v2) scores from 562 patients who underwent primary unilateral TKA. This cohort represented 75% of the 750 patients who underwent surgery during that time period; a total of 188 others (25%) either did not complete PROM scores at the designated times or were lost to follow-up. Minimum clinically important differences (MCIDs) were calculated for each PROM using a distribution-based method and were used to define meaningful clinical improvement. MCID values for KOOS and SF12v2 physical component summary (PCS) scores were calculated to be 10 and 5, respectively. A receiver operating characteristic analysis was used to determine threshold values for preoperative KOOS and SF12v2 PCS scores and their respective predictive abilities. Threshold values defined the point after which the likelihood of clinically meaningful improvement began to diminish. Multivariate regression was used to control for the effect of preoperative mental and emotional health, patient attributes quantified by SF12v2 mental component summary (MCS) scores, on

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Section: Methodsmentioning

confidence: 99%

Can Preoperative Patient-reported Outcome Measures Be Used to Predict Meaningful Improvement in Function After TKA?

Berliner

Brodke

Chan

et al. 2017

Clinical Orthopaedics &Amp; Related Research

230

181

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“…When investigating the effect of low and high baseline disability (based on the 25th and 75th percentile of the baseline score for ODI), the cutoffs for Table 3 Baseline adjusted mean of the change score, % change score, and final raw score for all PROMS (95% of CI) according to the global perceived effect scale at 1-year follow-up GPE Completely recovered (1) Much better (2) Somewhat better (3) No change (4) Somewhat worse (5) Much worse (6) Worse than ever (7) N (%) 1659 (24) 3265 (48) 1093 (16) 358 (5) 216 (3) 153 (2) 66 (1 ''failure'' and ''worsening'' in the PROMs varied considerably, both for change scores, % change scores, and the final raw score (Table 1x, appendix). For example, in the group with high disability at baseline, the failure cutoff for the mean % change in ODI was 30% higher than in the low disability group.…”

Section: Sensitivity Analysismentioning

confidence: 99%

“…Still, clinicians are often unfamiliar with their interpretation. In large cohorts, even small and clinically irrelevant PROM changes tend to reach statistical significance [4]. To provide cutoffs on PROM changes that are perceived as meaningful and important by the patients, the ''minimal important change'' (MIC) has been defined by various methods [5][6][7].…”

Section: Introductionmentioning

confidence: 99%

Criteria for failure and worsening after surgery for lumbar disc herniation: a multicenter observational study based on data from the Norwegian Registry for Spine Surgery

et al. 2017

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“…7 However, despite the draft PRO Guidance clearly distinguishing between the importance of change within-patient and between-group, the term ''MID'' is sometimes erroneously used for these 2 concepts interchangeably. Given the long history, inconsistent use, and vagueness of ''minimal,'' some PRO experts have suggested that we eliminate the terms ''MID'' and ''MCID'' from our vocabulary (Figure 1).…”

Section: A Select History Level Of Measurementmentioning

confidence: 99%

Interpreting Change in Scores on Patient-Reported Outcome Instruments

Coon¹,

Cappelleri

2016

Ther Innov Regul Sci

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Interpreting change in scores on patient-reported outcome instruments is a key aspect of instrument development. Without interpretation guidelines, the clinical meaning of significant improvements observed within a treatment group cannot be ascertained. While the field has contemplated this topic for several decades, there remains inconsistency in terminology, methods, and application. Careful selection of methods can result in determining when change is meaningful, but researchers must keep an open mind to the methods that best fit their study and instrument. In many cases, anchor-based methods are appropriate, but the statistical model that evaluates them should be defensible (eg, linear regression, repeated-measures modeling, logistic regression). Sometimes, researchers must entertain the use of novel methods that may be more appropriate for their planned studies and instrument (eg, standard setting, exit interviews, conjoint analysis). The selection of the method is best supported by clear, transparent communication with the regulatory agency to ensure that the method can support its goals.

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Methods for interpreting change over time in patient-reported outcome measures

Abstract: While CDFs serve an important role, they should not be a replacement for the careful investigation of a PRO's relevant responder definition using anchor-based methods and providing stakeholders with a relevant threshold for the interpretation of change over time.

Cited by 185 publications

References 43 publications

Can Preoperative Patient-reported Outcome Measures Be Used to Predict Meaningful Improvement in Function After TKA?

Can Preoperative Patient-reported Outcome Measures Be Used to Predict Meaningful Improvement in Function After TKA?

Criteria for failure and worsening after surgery for lumbar disc herniation: a multicenter observational study based on data from the Norwegian Registry for Spine Surgery

Interpreting Change in Scores on Patient-Reported Outcome Instruments

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