Moving from significance to real-world meaning: methods for interpreting change in clinical outcome assessment scores

Coon, Cheryl D.; Cook, Karon F.

doi:10.1007/s11136-017-1616-3

Cited by 95 publications

(117 citation statements)

References 11 publications

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“…Finally, the optimal scoring threshold was determined to identify patients whose AD would be considered "not in control." This study also validated the ADCT against a patientreported global assessment (i.e., PGA) of disease control, likely producing the most accurate and relevant data for establishing the validity of a new PRO because it is based on the patients' own experiences of the symptoms and/or functioning limitations 33 . In addition, a PGA of disease severity was used to measure patients' overall impression of their current AD severity.…”

Section: Discussionmentioning

confidence: 88%

Evaluating patient-perceived control of atopic dermatitis: design, validation, and scoring of the Atopic Dermatitis Control Tool (ADCT)

Pariser

Simpson

Gadkari

et al. 2019

Current Medical Research and Opinion

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Objectives: The Atopic Dermatitis Control Tool (ADCT) was designed to evaluate patient-perceived AD control and facilitate patient-physician discussion on long-term disease control. Methods: The study was performed in adult patients with AD. Development of the ADCT followed US Food and Drug Administration (FDA) guidelines on patient-reported outcome measures (PROMs). Qualitative research, including targeted literature review, interviews with clinical experts, and combined concept elicitation/cognitive debriefing with patients with AD, was conducted to provide a list of comprehensive concepts capturing AD control per physician and patient perspectives. Quantitative methods assessed psychometric properties of the instrument and defined the threshold for AD control. Results: The resulting pilot six-item ADCT, reflecting key concepts related to AD control, had 7-day recall and assessed symptoms and impacts on patients' everyday lives by severity and/or frequency. The ADCT showed good content validity (well understood by adult patients with AD), and quick completion time (<2 min). Psychometric analysis indicated no floor/ceiling effects for response distributions, particularly strong (r ! 0.80) inter-item correlations for the six ADCT items, robust construct validity (r > 0.50), and item-level discriminating ability (p < .03); this supported the derivation of a total score based on responses to all items. ADCT total score showed evidence of strong internal consistency reliability (Cronbach's alpha >0.80). A score !7 points was identified as an optimum threshold to identify patients whose AD is "not in control." Conclusions: No single validated instrument has been available to holistically evaluate patient-perceived AD control. The newly developed ADCT displays good-to-excellent content validity, construct validity, internal consistency, reliability, and discriminating ability.

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Section: Discussionmentioning

confidence: 88%

Evaluating patient-perceived control of atopic dermatitis: design, validation, and scoring of the Atopic Dermatitis Control Tool (ADCT)

Pariser

Simpson

Gadkari

et al. 2019

Current Medical Research and Opinion

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“…It has been suggested that the MID be used to identify ''responders'' to treatment. 21 For example, the U.S. Food and Drug Administration guidance document recommended identifying responders using empirical evidence from anchor-based methods and suggested that the ''difference in the PRO score for persons who rate their condition the same and better or worse can be used to define responders to treatment.'' 22 But using group-level change to identify responders would lead to misclassification of patients as responders when they have not actually changed.…”

Section: Methodsmentioning

confidence: 99%

Group and Individual-level Change on Health-related Quality of Life in Chiropractic Patients With Chronic Low Back or Neck Pain

Spritzer¹,

Sherbourne

Ryan

et al. 2019

Spine

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Study Design. A prospective observational study. Objective. The aim of this study was to evaluate group-level and individual-level change in health-related quality of life among persons with chronic low back pain or neck pain receiving chiropractic care in the United States. Summary of Background Data. Chiropractors treat chronic low back and neck pain, but there is limited evidence of the effectiveness of their treatment Methods. A 3-month longitudinal study of 2024 patients with chronic low back pain or neck pain receiving care from 125 chiropractic clinics at six locations throughout the United States was conducted. Ninety-one percent of the sample completed the baseline and 3-month follow-up survey (n ¼ 1835). Average age was 49, 74% females, and most of the sample had a college degree, were non-Hispanic White, worked full-time, and had an annual income of $60,000 or more. Group-level (within-group t tests) and individual-level (coefficient of repeatability) changes on the Patient-Reported Outcomes Measurement Information System (PROMIS-29) v2.0 profile measure was evaluated: six multi-item scales (physical functioning, pain, fatigue, sleep disturbance, social health, emotional distress) and physical and mental health summary scores. Results. Within-group t tests indicated significant group-level change (P < 0.05) for all scores except for emotional distress, and these changes represented small improvements in health (absolute value of effect sizes ranged from 0.08 for physical functioning to 0.20 for pain). From 13% (physical functioning) to 30% (PROMIS-29 v2.0 Mental Health Summary Score) got better from baseline to 3 months later according to the coefficient of repeatability. Conclusion. Chiropractic care was associated with significant group-level improvement in health-related quality of life over time, especially in pain. But only a minority of the individuals in the sample got significantly better (''responders''). This study suggests some benefits of chiropractic on functioning and wellbeing of patients with low back pain or neck pain.

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“…Anchor-based method is a traditional and widely used method, which can verify the signi cance of changes through external indicators based on patients' subjective feelings [29]. However, it also has many problems, such as determination of suitable anchor, calculation of the difference between positive and negative values, selection of mean and median according to scores distributions, the appropriateness of using clinical objective indicators as objective anchors, and so on [30,31].…”

Section: Socio-demographic Characteristics Of the Samplementioning

confidence: 99%

Exploration of the Methods of Establishing the Minimum Clinical Important Difference Based on Anchor and Its Application in the Quality of Life Measurement Scale QLICP-ES (V2.0) for Esophageal Cancer

Ren

Wan

et al. 2020

Preprint

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Background: The development of the minimum clinical important difference (MCID) can make it easier for researchers or doctors to judge the significance of research results and the effect of intervention measures, and improve the evaluation system of efficacy. This paper is aimed to calculate the MCID based on anchor and to develop MCID for esophageal cancer scale (QLICP-ES). Methods: Q29 of EORTC QLQ-C30 was used as the subjective anchor to calculate the score difference between each domain at discharge and admission. MCID was established according to two standards, "one grade difference"(A) and "at least one grade difference"(B), and developed by three methods: anchor-based method, ROC curve method and multiple linear regression model. Results: Most of the correlation coefficients of Q29 and various domains of the QLICP-ES were higher than 0.30. The rank of MCID values determined by different methods and standards were as follows: standard B> standard A, anchor-based method >ROC curve method > multiple linear regression model. The recommended MCID values of physical domain, psychological domain, social domain, common symptom and side-effects domain, the specific domain and the overall of the QLICP-ES were 7.8, 9.7, 4.7, 3.6, 4.3, 2.3 and 2.9, respectively. Conclusion: Different methods have their own advantages and disadvantages, and also different definitions and standards can be adopted according to research purposes and methods. A lot of different MCID values were presented in this paper so that it can be easy and convenient to select by users.

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Moving from significance to real-world meaning: methods for interpreting change in clinical outcome assessment scores

Abstract: By careful planning of anchor selection, study design, and psychometric methods, COA researchers can establish defensible responder thresholds that ultimately aid patients and clinicians in making informed treatment decisions.

Cited by 95 publications

References 11 publications

Evaluating patient-perceived control of atopic dermatitis: design, validation, and scoring of the Atopic Dermatitis Control Tool (ADCT)

Evaluating patient-perceived control of atopic dermatitis: design, validation, and scoring of the Atopic Dermatitis Control Tool (ADCT)

Group and Individual-level Change on Health-related Quality of Life in Chiropractic Patients With Chronic Low Back or Neck Pain

Exploration of the Methods of Establishing the Minimum Clinical Important Difference Based on Anchor and Its Application in the Quality of Life Measurement Scale QLICP-ES (V2.0) for Esophageal Cancer

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