Minimal important difference to infer changes in health-related quality of life—a systematic review

Jayadevappa, Ravishankar; Cook, R. J.; Chhatre, Sumedha

doi:10.1016/j.jclinepi.2017.06.009

Cited by 190 publications

(177 citation statements)

References 46 publications

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“…The MCID of SNOT‐22 is 9‐point . But, the within‐individual difference of CARAT (U) was 1.55, which did not meet the accepted MCID of 3.5 in CARAT . However, the Cohen's d was similar for SNOT‐22 and CARAT (U).…”

Section: Discussionmentioning

confidence: 92%

Add‐on probiotics in patients with persistent allergic rhinitis: A randomized crossover clinical trial

et al. 2019

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Objectives Current medications for allergic rhinitis (AR) may have undesirable side effects that could affect quality of life (QoL). Probiotics could be an alternative in these patients. The aim of this study was to assess the impact of add‐on probiotics on symptoms and QoL of patients. Methods In this randomized crossover clinical trial, patients with persistent AR were included. Each subject received budesonide with probiotic supplements (BP) or budesonide with placebo for 8 weeks (B), then vice versa for a further 8 weeks. There was an 8‐week washout. The primary outcome was the change of the Short Form 36‐Item Health Survey (SF‐36) score. The secondary outcomes were assessed by the Sinonasal Outcome Test‐22 (SNOT‐22) and the Control of Allergic Rhinitis and Asthma Test (CARAT) questionnaires. Results A total of 152 subjects (30.1 ± 7.6 years) completed the study. The SF‐36 score in both groups showed improvement compared with baseline values. Treatment BP was more effective than that of B. The Cohen's d and the number needed to treat for Physical Component Scales of SF‐36 were 0.40 and 10.77, respectively. These values for Mental Component Scales were 0.33 and 12.61, respectively. Also, treatment BP showed more reduction in the score of SNOT‐22 and CARAT. Conclusion This study showed that the addition of probiotics to budesonide significantly improved QoL in persistent AR patients. However, the clinical situation of these patients may be not very representative of AR patients in general population. Further studies are recommended. Level of Evidence 1bLaryngoscope, 129:1744–1750, 2019

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Section: Discussionmentioning

confidence: 92%

Add‐on probiotics in patients with persistent allergic rhinitis: A randomized crossover clinical trial

et al. 2019

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“…Although the study by Hopkins et al did not determine the accuracy (sensitivity and specificity) with which an improvement greater than the SNOT‐22 MCID identified patients who reported improved quality of life on the anchor question, previous studies have reported that there is inherent variability in any outcome metric's MCID. This variability may lead to an overall suboptimal accuracy for the MCID to definitively identify all patients who truly experience noticeable subjective improvement . This concept is best reflected by the finding that our estimates of the SNOT‐22 MCID, including those which maximises sensitivity and specificity, only had sensitivities of 50‐60% for detecting patients who reported noticeable improvement with medical management.…”

Section: Discussionmentioning

confidence: 99%

“…The 22‐item Sinonasal Outcome Test (SNOT‐22), which reflects nasal, sleep, ear/facial discomfort and emotional symptoms, is one such questionnaire and is widely utilised in both the clinical and research settings . An important concept regarding the use of patient‐reported outcome measures, such as the SNOT‐22, is the minimal clinically important difference (MCID) . The MCID reflects the minimum change in a patient‐reported outcome measure that translates to a noticeable, and therefore clinically meaningful, change for the patient.…”

Section: Introductionmentioning

confidence: 99%

“…10,11 An important concept regarding the use of patient-reported outcome measures, such as the SNOT-22, is the minimal clinically important difference (MCID). 12,13 The MCID reflects the minimum change in a patient-reported outcome measure that translates to a noticeable, and therefore clinically meaningful, change for the patient. The SNOT-22 has been extensively validated and its MCID has been defined in patients undergoing endoscopic sinus surgery.…”

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confidence: 99%

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Minimal clinically important difference for the 22‐item Sinonasal Outcome Test in medically managed patients with chronic rhinosinusitis

Phillips

Hoehle

Caradonna

et al. 2018

Clinical Otolaryngology

102

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“…Along with other analytical approaches (e.g., Cohen's effect size, number needed to treat [NNT]), one way to estimate clinical relevance of recent TD trial results would be to identify a minimal clinically important difference (MCID) for the AIMS total score. Two approaches are generally used to estimate MCIDs: distribution‐based, which relies on a standard deviation (SD) or standard error of the measurement; and anchor‐based, which uses an external measure (e.g., 7‐point global assessment scale) as an independent criterion for improvement . An MCID for the AIMS has not been established in patients with TD, possibly because of the lack of large, well‐controlled, and prospectively designed studies in this population.…”

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confidence: 99%

Abnormal involuntary movement scale in tardive dyskinesia: Minimal clinically important difference

et al. 2019

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Background A minimal clinically important difference has not been established for the Abnormal Involuntary Movement Scale in patients with tardive dyskinesia. Valbenazine is a vesicular monoamine transporter 2 inhibitor approved for the treatment of tardive dyskinesia in adults. Efficacy in randomized, double‐blind, placebo‐controlled trials was defined as the change from baseline in Abnormal Involuntary Movement Scale total score (sum of items 1‐7). Objectives To estimate an minimal clinically important difference for the Abnormal Involuntary Movement Scale using valbenazine trial data and an anchor‐based method. Methods Data were pooled from three 6‐week double‐blind, placebo‐controlled trials: KINECT (NCT01688037), KINECT 2 (NCT01733121), and KINECT 3 (NCT02274558). Valbenazine doses were pooled for analyses as follows: “low dose,” which includes 40 or 50 mg/day; and “high dose,” which includes 75 or 80 mg/day. Mean changes from baseline in Abnormal Involuntary Movement Scale total score were analyzed in all participants (valbenazine‐ and placebo‐treated) with a Clinical Global Impression of Change‐Tardive Dyskinesia or Patient Global Impression of Change score of 1 (very much improved) to 3 (minimally improved). Results The least squares mean improvement from baseline to week 6 in Abnormal Involuntary Movement Scale total score was significantly greater with valbenazine (low dose: –2.4; high dose: –3.2; both, P < 0.001) versus placebo (–0.7). An minimal clinically important difference of 2 points was estimated based on least squares mean changes in Abnormal Involuntary Movement Scale total score in participants with a Clinical Global Impression of Change‐Tardive Dyskinesia score ≤3 at week 6 (mean change: –2.2; median change: –2) or Patient Global Impression of Change score ≤3 at week 6 (mean change: –2.0; median change: –2). Conclusions Results from an anchor‐based method indicate that a 2‐point decrease in Abnormal Involuntary Movement Scale total score may be considered clinically important. © 2019 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.

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Minimal important difference to infer changes in health-related quality of life—a systematic review

Cited by 190 publications

References 46 publications

Add‐on probiotics in patients with persistent allergic rhinitis: A randomized crossover clinical trial

Add‐on probiotics in patients with persistent allergic rhinitis: A randomized crossover clinical trial

Minimal clinically important difference for the 22‐item Sinonasal Outcome Test in medically managed patients with chronic rhinosinusitis

Abnormal involuntary movement scale in tardive dyskinesia: Minimal clinically important difference

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