Trial reportHealth and quality of life outcomes2020
Practical issues encountered while determining Minimal Clinically Important Difference in Patient-Reported Outcomes.
Trial report in Health and quality of life outcomes, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01240772 (Cost-effectiveness of New Surgical Treatments for Haemorrhoidal Disease - Randomized Controlled Trial Comparing Transanal Doppler-guided Arterial Ligation With Mucopexy and Stapled Haemorrhoidopexy), which is not on this map. Cited by 22 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Cost-effectiveness of New Surgical Treatments for Haemorrhoidal Disease - Randomized Controlled Trial Comparing Transanal Doppler-guided Arterial Ligation With Mucopexy and Stapled Haemorrhoidopexy (Longo's Technique)
Who cites it
22 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Comparative effects of salt substitutes on blood pressure, cardiovascular events and mortality: a systematic review and network meta-analysis.BMC medicine · 2026Pooled it
- Inconsistencies in clinically significant outcome metrics for knee cartilage repair: a systematic review.Musculoskeletal surgery · 2025Pooled it
- Longitudinal data on health-related quality of life and its association with time to readmission in bladder perfusion patients.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Observational
- Investigation of Minimal Clinically Important Difference of the Extended Barthel Index in Inpatients With Acute to Subacute Stroke in China.Hong Kong journal of occupational therapy : HKJOT · 2026Article
- Exploring multiple minimal clinically important differences for the esophageal cancer scale QLICP-ES (V2.0) based on anchor-based and distribution-based methods.Scientific reports · 2026Article
- Development and validation of machine learning models for predicting rehabilitation non-response after knee arthroplasty.Frontiers in rehabilitation sciences · 2026Article
- The Minimal Clinically Important Difference for the "Patient Activation Measure".Kidney international reports · 2025Article
- Clinical cut-offs for hip- and knee arthroplasty outcome - minimal clinically important improvement (MCII) and patient acceptable symptom state (PASS) of patient-reported outcome measures (PROM).Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025Article
- Estimating the minimum clinically important difference (MCID) of the five-repetition sit-to-stand test in patients with lumbar disc herniation.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2025Article
- Minimal Clinically Important Difference in Patients with Acute Neck Pain Undergoing Conservative Treatment with Korean Medicine.Journal of pain research · 2025Article
- Methodological considerations in calculating the minimal clinically important change score for the core outcome measures index (COMI): insights from a large single-centre spine surgery registry.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2024Article
- Calculation of the minimum clinically important difference (MCID) using different methodologies: case study and practical guide.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2024Article
- Overall Reporting Quality of Randomized Controlled Trials of Acupuncture for Knee Osteoarthritis: A Systematic Review.Journal of pain research · 2024Article
- Case-mix adjustments for patient reported experience and outcome measures in primary care: an empirical approach to identify patient characteristics as case-mix adjusters based on a secondary analysis of an international survey among patients and their general practitioners in 34 countries.Journal of patient-reported outcomes · 2023Article
- Clinically important change for the FACIT-Fatigue scale in paroxysmal nocturnal hemoglobinuria: a derivation from international PNH registry patient data.Journal of patient-reported outcomes · 2023Article
- Off the RADAR; questions regarding the trial protocol of a randomised controlled trial of antipsychotic reduction and discontinuation.Journal of psychopharmacology (Oxford, England) · 2023Article
- AFOs Improve Stride Length and Gait Velocity but Not Motor Function for Most with Mild Cerebral Palsy.Sensors (Basel, Switzerland) · 2023Article
- Precision in treatment evaluation: importance of minimal clinically important differences (MCIDs) of outcome measures for autoimmune blistering diseases.Frontiers in immunology · 2023Review
- Minimum clinically important differences in the Minnesota Living with Heart Failure questionnaire: from a study of heart failure patients treated with integrated Chinese and Western medicine.Frontiers in cardiovascular medicine · 2023Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
backgroundUsing a real dataset, we highlighted several major methodological issues raised by the estimation of the Minimal Clinically Important Difference (MCID) of a Patient-Reported Outcomes instrument. We especially considered the management of missing data and the use of more than two times of measurement. While inappropriate missing data management and inappropriate use of multiple time points can lead to loss of precision and/or bias in MCID estimation, these issues are almost never dealt with and require cautious considerations in the context of MCID estimation.
methodsWe used the LIGALONGO study (French Randomized Controlled Trial). We estimated MCID on the SF-36 General Health score by comparing many methods (distribution or anchor-based). Different techniques for imputation of missing data were performed (simple and multiple imputations). We also consider all measurement occasions by longitudinal modeling, and the dependence of the score difference on baseline.
resultsThree hundred ninety-three patients were studied. With distribution-based methods, a great variability in MCID was observed (from 3 to 26 points for improvement). Only 0.2 SD and 1/3 SD distribution methods gave MCID values consistent with anchor-based methods (from 4 to 7 points for improvement). The choice of missing data imputation technique clearly had an impact on MCID estimates. Simple imputation by mean score seemed to lead to out-of-range estimate, but as missing not at random mechanism can be hypothesized, even multiple imputations techniques can have led to an slight underestimation of MCID. Using 3 measurement occasions for improvement led to an increase in precision but lowered estimates.
conclusionThis practical example illustrates the substantial impact of some methodological issues that are usually never dealt with for MCID estimation. Simulation studies are needed to investigate those issues.
trial registrationNCT01240772 (ClinicalTrials.gov) registered on November 15, 2010.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.