Understanding the minimum clinically important difference: a review of concepts and methods

Copay, Anne G.; Subach, Brian R.; Glassman, Steven D.; Polly, David W.; Schuler, Thomas C.

doi:10.1016/j.spinee.2007.01.008

Cited by 1,352 publications

(1,341 citation statements)

References 27 publications

Supporting

Mentioning

1,309

Contrasting

Unclassified

Order By: Relevance

“…Using a very strict estimate of the MID may lead to success being defined as something unachievable for a substantial proportion of patients, whereas using a lenient MID could lead to overestimation of the responder rate. Therefore, it has been recommended that distribution‐based measures are used only to provide supportive information for anchor‐based estimates of the MID; generating an overall body of evidence and agreeing on an MID or a small range of MIDs is generally acknowledged to be the most appropriate strategy 28, 29, 34…”

Section: Discussionmentioning

confidence: 99%

ThePAC‐SYMquestionnaire for chronic constipation: defining the minimal important difference

Yiannakou

Tack

Piessevaux

et al. 2017

Aliment Pharmacol Ther

View full text Add to dashboard Cite

SummaryBackgroundThe Patient Assessment of Constipation‐Symptoms (PAC‐SYM) questionnaire is frequently used in clinical trials of constipation. However, the threshold for reduction in total PAC‐SYM score used to define a clinical response on this 0‐4 point scale has not undergone formal appraisal, and its relationship with clinical benefit as perceived by patients has not been defined.AimTo determine the minimal important difference in PAC‐SYM score, and the optimum cut‐off value for defining responders.MethodsThe minimal important difference was estimated using data from six international phase 3/4, double‐blind, randomised controlled trials of prucalopride in patients with chronic constipation (NCT01147926, NCT01424228, NCT01116206, NCT00485940, NCT00483886, NCT00488137), with anchor‐ and distribution‐based approaches. Five appropriate patient‐reported outcomes were selected as anchors. In addition, receiver operating characteristics (ROC) curve analyses were used to investigate responder discrimination for each anchor.ResultsData from 2884 patients were included. Minimal important difference estimates ranged from –0.52 to –0.63 across the five anchors. Estimates were not affected by study location but were consistently lower for rectal symptoms than for abdominal and stool symptoms. Distribution‐based estimates were considerably lower than anchor‐based estimates. ROC curve analyses showed optimum cut‐off scores for discriminating responders to be similar to anchor‐based minimal important difference estimates.ConclusionsAnchor‐based methods gave consistent results for the minimal important difference, at approximately –0.6, and this value was close to the ROC‐determined optimal cut‐off scores for responder discrimination. This value could be considered in clinical practice. A slightly more conservative threshold (eg –0.75) could be used in clinical trials to reduce the placebo response rate.

show abstract

Section: Discussionmentioning

confidence: 99%

ThePAC‐SYMquestionnaire for chronic constipation: defining the minimal important difference

Yiannakou

Tack

Piessevaux

et al. 2017

Aliment Pharmacol Ther

View full text Add to dashboard Cite

show abstract

“…Still, it has several weaknesses related to recall bias [17], lack of objectivity [36], and for not taking into account the measurement precision [6]. More objective criteria, such as return to work or use of pain killers, have been proposed [36].…”

Section: Methodological Challengesmentioning

confidence: 99%

“…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%

“…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]. A recent review proposed an MIC cutoff for the ODI of ten points, or 30% improvement from baseline [8].…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

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

View full text Add to dashboard Cite

“…Outcome measure change was evaluated on the basis of both the mean change and the percentage of patients reaching a minimum clinically important difference threshold. The minimum clinically important difference is a threshold level of outcome score change above which patients recognize their improvement to be clinically relevant [2]. We used the previously published minimum clinically important difference threshold of 10 points for the Oswestry Disability Index score [10].…”

Section: Outcome Measuresmentioning

confidence: 99%

Minimally Invasive Transforaminal Lumbar Interbody Fusion for Spondylolisthesis and Degenerative Spondylosis: 5-year Results

Park

Lee

et al. 2014

Clinical Orthopaedics &Amp; Related Research

View full text Add to dashboard Cite

Background Multiple studies have reported favorable short-term results after treatment of spondylolisthesis and other degenerative lumbar diseases with minimally invasive transforaminal lumbar interbody fusion. However, to our knowledge, results at a minimum of 5 years have not been reported. Questions/purposes We determined (1) changes to the Oswestry Disability Index, (2) frequency of radiographic fusion, (3) complications and reoperations, and (4) the learning curve associated with minimally invasive transforaminal lumbar interbody fusion at minimum 5-year followup. Methods We reviewed our first 124 patients who underwent minimally invasive transforaminal lumbar interbody fusion to treat low-grade spondylolisthesis and degenerative lumbar diseases and did not need a major deformity correction. This represented 63% (124 of 198) of the transforaminal lumbar interbody fusion procedures we performed for those indications during the study period (2003)(2004)(2005)(2006)(2007). Eighty-three (67%) patients had complete 5-year followup. Plain radiographs and CT scans were evaluated by two reviewers. Trends of surgical time, blood loss, and hospital stay over time were examined by logarithmic curve fit-regression analysis to evaluate the learning curve. Results At 5 years, mean Oswestry Disability Index improved from 60 points preoperatively to 24 points and 79 of 83 patients (95%) had improvement of greater than 10 points. At 5 years, 67 of 83 (81%) achieved radiographic fusion, including 64 of 72 patients (89%) who had single-level surgery. Perioperative complications occurred in 11 of 124 patients (9%), and another surgical procedure was performed in eight of 124 patients (6.5%) involving the index level and seven of 124 patients (5.6%) at adjacent levels. There were slowly decreasing trends of surgical time and hospital stay only in single-level surgery and almost no change in intraoperative blood loss over time, suggesting a challenging learning curve. Conclusions Oswestry Disability Index scores improved for patients with spondylolisthesis and degenerative lumbar diseases treated with minimally invasive transforaminal lumbar interbody fusion at minimum 5-year followup. We suggest this procedure is reasonable for properly selected patients with these indications; however, traditional approaches should still be performed for patients with high-grade spondylolisthesis, patients with a severely collapsed disc space and no motion seen on the dynamic radiographs, patients who need multilevel decompression and arthrodesis, and patients with kyphoscoliosis needing correction.

show abstract

Understanding the minimum clinically important difference: a review of concepts and methods

Cited by 1,352 publications

References 27 publications

ThePAC‐SYMquestionnaire for chronic constipation: defining the minimal important difference

ThePAC‐SYMquestionnaire for chronic constipation: defining the minimal important difference

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

Minimally Invasive Transforaminal Lumbar Interbody Fusion for Spondylolisthesis and Degenerative Spondylosis: 5-year Results

Contact Info

Product

Resources

About