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The anchor design of anchor-based method to determine the minimal clinically important difference: a systematic review

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HEALTH AND QUALITY OF LIFE OUTCOMES 2023年第1期21卷 74-74页

作者： Zhang, Yu Xi, Xiaoyu Huang, Yuankai China Pharmaceut Univ 639Longmian AveJiangning Dist Nanjing 211198 Jiangsu Peoples R China

BackgroundPositive results for clinical outcomes should be not only statistically significant, but also clinically significant. The minimum clinically important difference (MCID) is used to define the minimum threshold of clinical significance. The anchor-based method is a classical method for ascertaining MCID. This study aimed to summarise the design of the anchors of the anchor-based method by reviewing the existing research and providing references and *** study was mainly based on literature research. We performed a systematic search using Web of Science, PubMed, CNKI, Wanfang, and VIP databases. Two reviewers independently screened titles and abstracts to identify relevant articles. Data were extracted from eligible articles using a predefined data collection form. Discrepancies were resolved by discussion and the involvement of a third *** hundred and forty articles were retained for final analysis. For the design of anchors, Subjective anchors (99.12%) were the most common type of anchor used, mainly the Patient's rating of change or patient satisfaction (66.47%) and related scale health status evaluation items or scores (39.41%). Almost half of the studies (48.53%) did not assess the correlation test between the anchor and the research indicator or scale. The cut-off values and grouping were usually based on the choice of the anchor types. In addition, due to the large number of included studies, this study selected the most calculated SF-36 (28 articles) for an in-depth analysis. The results showed that the overall design of the anchor and the cut-off value were the same as above. The statistical methods used were mostly traditional (mean change, ROC). The MCID thresholds of these studies had a wide range (SF-36 PCS: 2-17.4, SF-36 MCS: 1.46-10.28), and different anchors or statistical methods lead to different *** is of great importance to select several types of anchors and to use more reliable statisti

关键词： Minimal clinically important difference anchor-based method Patient-reported Outcome

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Comparison of anchor-based methods for estimating thresholds of meaningful within-patient change using simulated PROMIS PF 20a data under various joint distribution characteristic conditions

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QUALITY OF LIFE RESEARCH 2023年第5期32卷 1277-1293页

作者： Qin, Shanshan Nelson, Lauren Williams, Nicole Williams, Valerie Bender, Randall McLeod, Lori RTI Hlth Solut 3040 Cornwallis Rd Res Triangle Pk NC 27709 USA ICF Int 1902 Reston Metro Plaza Reston VA 20190 USA

Purpose To compare the performance of anchor-based methods for estimating thresholds of meaningful within-patient change (i.e., individual change) of clinical outcome assessments in conditions reflecting data characteristics of small- to medium-sized clinical trials. methods Datasets were generated from the joint distributions of the PROMIS PF 20a T-score changes and a seven-point global change anchor measure. The 108 simulation conditions (1000 replications per condition) included combinations of three marginal distributions of T-score changes, three improvement percentages in the anchor measure, four levels of responsiveness correlations, and three sample sizes. Threshold estimation methods included mean change, median change, ROC curve, predictive modeling, half SD, and SEM. Relative bias, precision, accuracy, and measurement significance of the estimates were evaluated based on comparison with true thresholds and IRT-based individual reliable changes of PROMIS scores. Quantile regression models were applied to select and interpret effects of simulation conditions on estimation bias. Results When PROMIS T-score changes were distributed normally, the predictive modeling method performed best with 50% or more responders identified by the anchor;the mean and median methods were preferred with 30% responders. For skewed distributions, the median method and ROC method gained more advantages. Among the evaluated study conditions, the improvement percentage condition had the most obvious effects on estimation bias. Conclusion To establish accurate and precise thresholds, clinical researchers are recommended to prioritize study designs with at least 50% anchor-defined responders and strongly responsive target endpoints with highly reliable scoring calibration and to select optimal anchor-based methods given the data characteristics.

关键词： Patient-reported outcome Distribution-based method anchor-based method Responder definition Meaningful change Minimal important difference MID Minimal clinically important difference MCID

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SvRetina-LPD: A Sliding Vertex-based RetinaNet for Robust Multi-Oriented License Plate Detection

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IEEE TRANSACTIONS ON INTELLIGENT TRANSPORTATION SYSTEMS 2024年第11期25卷 16421-16434页

作者： Yang, Shengying Zhang, Zhihao Shi, Wenbin Feng, Boyang Hua, Yongzhu Lei, Jingsheng Zhejiang Univ Sci & Technol Sch Informat & Elect Engn Hangzhou 310023 Peoples R China Univ Melbourne Dept Math & Stat Melbourne Vic 3000 Australia Hangzhou Dianzi Univ Sch Elect & Informat Engn Hangzhou 310018 Peoples R China

The performance of license plate detection has greatly improved with the development of deep learning. However, two challenges remain. First, in unconstrained scenarios, such as rotation and uneven lighting, license plate detection still faces significant challenges. Secondly, traditional horizontal bounding boxes are not suitable for representing multi-oriented license plates. And quadrilateral boxes can effectively represent them though, they cannot avoid the confusion caused by sequential label points. To address these challenges, we propose a license plate detection method called SvRetina-LPD. Specifically, we design an inception residual fusion pyramid network, which fuses multiple layers of features thoroughly. Then, by integrating spatial attention and channel attention, the inception residual multi-dimensional attention network is developed to weaken the noise and highlight the features of the license plate. Finally, we introduce a sliding vertex head network that incorporates a sliding vertex branch and regresses four length ratios to represent the relative sliding offsets of the corner points of the quadrilateral to the corresponding sides of the bounding rectangle. This method can accurately detect multi-directional license plate regions and effectively avoids the sequential label points. Extensive experimental tests were conducted on datasets such as CCPD, AOLP, and CLPD. On the CCPD test set, SvRetina-LPD demonstrated a high accuracy of $97.9\%$ , surpassing existing methods. In addition, SvRetina-LPD also demonstrated excellent detection accuracy in other subsets of CCPD, including various challenging scenarios, demonstrating its ability to accurately detect multi-directional license plates in unconstrained scenarios.

关键词： Licenses License plate detection multi-orientation convolutional neural networks anchor-based method License plate detection multi-orientation convolutional neural networks anchor-based method

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A weighted predictive modeling method for estimating thresholds of meaningful within-individual change for patient-reported outcomes

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QUALITY OF LIFE RESEARCH 2025年第6期34卷 1797-1808页

作者： Zhao, Chong-Ye Yan, Min-Qian Xu, Xiao-Han Ou, Chun-Quan Southern Med Univ Sch Publ Hlth Dept Biostat Guangdong Prov Key Lab Trop Dis ResState Key Lab Guangzhou 510515 Peoples R China

PurposeCalculating the threshold for meaningful within-individual change (MWIC) is essential for interpreting patient-reported outcomes (PRO). However, traditional methods of determining MWIC threshold yield varying estimates and lack a standardized approach. We aim to propose a novel method for more accurate MWIC threshold *** developed a weighted predictive modeling method. The weighting involved using the rank difference between PRO score change and the anchor of each individual. A Monte Carlo simulation was conducted to compare the performance of the new method and that of existing state-of-the-art methods. Simulation parameters included distributions of PRO score changes, sample sizes, improvement proportions, and correlation strengths. Statistical performance was assessed using relative bias (rbias), coefficient of variation (CV), and relative root mean squared error (rRMSE).ResultsDistribution-based methods had the largest rbias and rRMSE among all methods. Existing anchor-based methods except for the Terluin 2022 method were biased when the correlation strength was weak or when the improvement proportion was not 50%. The Terluin 2022 method requires estimating an important reliability parameter, and this method had highest CV compared to other predictive modeling methods. The new weighted method demonstrated the smallest rRMSE across most simulation settings. It also maintained relatively high accuracy under weak correlation strength or imbalanced improvement proportion. Similar results were presented under normal or skewed distributions of PRO score *** novel method offers a simple and feasible alternative to existing predictive modeling methods for estimating MWIC threshold, which can facilitate the application of PRO.

关键词： Patient-reported outcomes Meaningful within-individual change anchor-based method Weighted predictive modeling

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Minimal important changes in standard deviation units are highly variable and no universally applicable value can be determined

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JOURNAL OF CLINICAL EPIDEMIOLOGY 2022年 145卷 92-100页

作者： Tsujimoto, Yasushi Fujii, Tomoko Tsutsumi, Yusuke Kataoka, Yuki Tajika, Aran Okada, Yohei Carrasco-Labra, Alonso Devji, Tahira Wang, Yuting Guyatt, Gordon H. Furukawa, Toshi A. Kyoto Univ Dept Hlth Promot & Human Behav Grad Sch Med Sch Publ Hlth Kyoto Japan Kyoritsu Hosp Dept Nephrol & Dialysis Nagoya Aichi Japan Sci Res Works Peer Support Grp SRWS PSG Osaka Japan Jikei Univ Hosp Intens Care Unit Tokyo Japan Kyoto Univ Grad Sch Med Human Hlth Sci Kyoto Japan Natl Hosp Org Mito Med Ctr Dept Emergency Med 280 Sakuranosato Ibarakimachi Ibaraki Japan Kyoto Univ Dept Healthcare Epidemiol Grad Sch Med Sch Publ Hlth Kyoto Japan Kyoto Min Iren Asukai Hosp Dept Internal Med Kyoto Japan Kyoto Univ Dept Community Med Sect Clin Epidemiol Grad Sch Med Kyoto Japan Kyoto Univ Dept Prevent Serv Grad Sch Med Sch Publ Hlth Kyoto Japan Univ Penn Sch Dent Med Ctr Integrat Global Oral Hlth Philadelphia PA 19104 USA McMaster Univ Dept Hlth Res Methods Evidence & Impact Hamilton ON Canada

Objectives: This study aims to describe the distribution of anchor-based minimal important change (MIC) estimates in standard deviation (SD) units and examine if the robustness of such estimates depends on the specific SD used or on the methodological credibility of the anchor-based *** and Setting: We included all anchor-based MIC estimates from studies published in MEDLINE and relevant literature databases upto October 2018. Each MIC was converted to SD units using baseline, endpoint, and change from baseline SDs. We performed a descriptive analysis of MICs in SD units and checked how the distribution would change if MICs with low methodological credibility were excluded from the ***: We included 1,009 MIC estimates from 182 studies. The medians and interquartile ranges of MICs in SD units were 0.43 (0.25 to 0.69), 0.42 (0.22 to 0.70), and 0.51 (0.28 to 0.78) for baseline, endpoint, and change SD units, respectively. Some MICs were extremely large or small. The distribution did not change significantly after excluding MICs estimated by less credible ***: The size of the universally applicable MIC in SD units could not be determined. anchor-based MICs in SD units were widely distributed, with more than half in the range of 0.2 to 0.8. (c) 2022 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license ( http:// ***/ licenses/ by- nc-nd/ 4.0/ )

关键词： Minimal important change patient-reported outcome anchor-based method distribution-based method effect size

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Minimal important clinical difference values are not uniformly valid in the active duty military population recovering from shoulder surgery

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JOURNAL OF SHOULDER AND ELBOW SURGERY 2024年第11期33卷 E596-E605页

作者： Sheean, Andrew J. Tenan, Matthew S. DeFoor, Mikalyn T. Cognetti, Daniel J. Bedi, Asheesh Lin, Albert Dekker, Travis J. Dickens, Jonathan F. San Antonio Mil Med Ctr 3551 Roger Brooke Dr San Antonio TX 78234 USA Def Hlth Agcy College Pk MD USA West Virginia Univ Rockefeller Neurosci Inst Morgantown WV 26506 USA NorthShore Univ Hlth Syst Skokie IL USA Univ Pittsburg Med Ctr Pittsburgh PA USA US Air Force Acad Med Grp Colorado Springs CO 80840 USA Duke Univ Durham NC USA Walter Reed Natl Mil Med Ctr Bethesda MD USA Uniformed Serv Univ Hlth Sci Bethesda MD 20814 USA Gothenburg Univ Sahlgrenska Acad Inst Clin Sci Gothenburg Sweden

Background: There are multiple methods for calculating the minimal clinically important difference (MCID) threshold, and previous reports highlight heterogeneity and limitations of anchor-based and distribution-based analyses. The Warfighter Readiness Survey assesses the perception of a military population's fitness to deploy and may be used as a functional index in anchor-based MCID calculations. The purpose of the current study in a physically demanding population undergoing shoulder surgery was to compare the yields of 2 different anchor-based methods of calculating MCID for a battery of PROMs, a standard receiver operating characteristic (ROC) curve-based MCIDs and baseline-adjusted ROC curve MCIDs. methods: All service members enrolled prospectively in a multicenter database with prior shoulder surgery that completed pre- and postoperative PROMs at a minimum of 12 months were included. The PROM battery included Single Assessment Numeric Evaluation (SANE), American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), Patient Reported Outcome Management Information System (PROMIS) physical function (PF), PROMIS pain interference (PI), and the Warfighter Readiness Survey. Standard anchor-based and baseline-adjusted ROC curve MCIDs were employed to determine if the calculated MCIDs were both statistically and theoretically valid (95% confidence interval [CI] either completely negative or positive). Results: A total of 117 patients (136 operations) were identified, comprising 83% males with a mean age of 35.7 +/- 10.4 years and 47% arthroscopic labral repair/capsulorrhaphy. Using the standard, anchor-based ROC curve MCID calculation, the area under the curve (AUC) for SANE, ASES, PROMIS PF, and PROMIS PI were greater than 0.5 (statistically valid). For ASES, PROMIS PF, and PROMIS PI, the calculated MCID 95% CI all crossed 0 (theoretically invalid). Using the baseline-adjusted ROC curve MCID calculation, the MCID estimates for SANE, ASES, and PRO

关键词： Minimal clinically important difference (MCID) patient reported outcome measures (PROM) shoulder receiver operator curve (ROC) anchor-based method military readiness

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Establishing how much improvement in lung function and distance walked is clinically important for adult patients with Pompe disease

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EUROPEAN JOURNAL OF NEUROLOGY 2024年第5期31卷 e16223-e16223页

作者： Lika, Aglina Andrinopoulou, Eleni-Rosalina van Der Beek, Nadine A. M. E. Rizopoulos, Dimitris van Der Ploeg, Ans T. Kruijshaar, Michelle E. Erasmus MC Univ Med Ctr Ctr Lysosomal & Metab Dis Dept Pediat Dr Molewaterpl 40 NL-3015 GD Rotterdam Netherlands Erasmus MC Univ Med Ctr Dept Biostat Rotterdam Netherlands Erasmus MC Univ Med Ctr Dept Epidemiol Rotterdam Netherlands Erasmus MC Univ Med Ctr Ctr Lysosomal & Metab Dis Dept Neurol Rotterdam Netherlands

Background and purposePompe disease is a rare, inheritable, progressive metabolic myopathy. This study aimed to estimate the minimal clinically important difference (MCID) for an improvement in forced vital capacity in the upright seated position (FVCup) and the 6-min walk test (6MWT) after a year of treatment with enzyme replacement *** were obtained from two prospective follow-up studies. Between-group and within-group MCIDs were estimated using anchor-based methods. Additionally, a distribution-based method was used to generate supportive evidence. As anchors, self-reported change in health and in physical functioning, shortness of breath and a categorization of the Short-Form 36 Physical Component Summary score were used. anchor appropriateness was assessed using Spearman correlations (absolute values >= 0.29) and a sufficient number of observations in each *** all, 102 patients had at least one FVCup or 6MWT measurement during enzyme replacement therapy. based on the anchors assessed as appropriate, the between-group MCID for an improvement in FVCup ranged from 2.47% to 4.83% points. For the 6MWT, it ranged from 0.35% to 7.47% points which is equivalent to a distance of 2.18-46.61 m and 1.97-42.13 m for, respectively, a man and a woman of age 50, height 1.75 m and weight 80 kg. The results of the distribution-based method were within these ranges when applied to change in the outcome *** MCIDs for FVCup and 6MWT derived in this study can be used to interpret differences between and within groups of patients with Pompe disease in clinical trials and cohort studies.

关键词： anchor-based method clinically meaningful threshold forced vital capacity minimal clinically important difference minimal important change Pompe disease 6-minute walk test

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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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HEALTH AND QUALITY OF LIFE OUTCOMES 2021年第1期19卷 173-173页

作者： Ren, Dandan Wu, Ting Wan, Chonghua Li, Gaofeng Qi, Yanbo Fang, Yujing Zhong, Jiudi Guangdong Med Univ Sch Humanities & Management Res Ctr Qual Life & Appl Psychol Dongguan 523808 Peoples R China Kunming Med Univ Yunnan Tumor Hosp Affiliated Hosp 3 Kunming 650106 Yunnan Peoples R China Ctr Dis Control & Prevent Yunnan Prov Ctr Response & Management Emergence Publ Hlth Eve Kunming 650022 Yunnan Peoples R China Sun Yat Sen Univ Collaborat Innovat Ctr Canc Med Dept Thorac Surg State Key Lab Oncol South ChinaCanc Ctr Guangzhou 510060 Peoples R China

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 The item Q29 (How do you evaluate your overall health in the past week with 7 grades answers from 1 very poor to 7 excellent)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 models. In terms of anchor-based method, the mean of the absolute value of the difference before and after treatments is MCID. The point with the best sensitivity and specificity-Yorden index at the ROC curve is MCID for ROC curve method. In contrast, the predicted mean value based on a multiple linear regression model and the parameters of each factor is MCID. 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 models. 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 tha

关键词： Quality of life Esophageal cancer The minimum clinical important difference anchor-based method ROC curve Multiple linear regression model

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Physical activity in COPD: Minimal clinically important difference for medical events

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CHRONIC RESPIRATORY DISEASE 2018年第16期16卷 1479973118816424-1479973118816424页

作者： Teylan, Merilee Kantorowski, Ana Homsy, Diana Kadri, Reema Richardson, Caroline Moy, Marilyn VA Boston Healthcare Syst Pulm & Crit Care Med Sect Boston MA USA Univ Michigan Dept Family Med Ann Arbor MI 48109 USA Harvard Med Sch Boston MA 02115 USA

Estimates of the minimal clinically important difference (MCID) for physical activity (PA) in chronic obstructive pulmonary disease (COPD) are needed. The objective is to provide an anchor-based estimate of the MCID for daily step count. PA was promoted in persons with COPD using a pedometer (Omron HJ-720ITC) alone or a pedometer plus interactive website for 3 months. Participants wore the pedometer daily and received phone calls monthly to ascertain medical events. Medical events were counted when a participant self-reported that he/she had (1) worsening of breathing, (2) change to breathing medications, (3) medical care from an emergency room for any reason, or (4) hospitalization for any reason. Generalized linear regression models assessed daily step count as change at the end of study and averaged over the 15, 31, or 61 days centered on the event, in those with an event compared to those without one. All categories of events carried equal weight in the analyses. We studied 93 persons, 46 of whom had an event. Participants who experienced an event had a decrease of 1086 (95% confidence interval (CI): -2124 to -48) or 887 (95% CI: -2030 to 257) steps/day in the pedometer plus website or pedometer alone groups, respectively, compared to those without one. In the days centered on an event, participants who had an event experienced a decrease of 882-983 steps/day (pedometer plus website) or a decrease of 351-495 steps/day (pedometer alone), compared to those without one. The MCID for PA in COPD ranges from 350 steps/day to 1100 steps/day.

关键词： anchor-based method daily step count exercise physical activity COPD

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Impact of the occurrence of a response shift on the determination of the minimal important difference in a health-related quality of life score over time

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HEALTH AND QUALITY OF LIFE OUTCOMES 2016年第1期14卷 1-15页

作者： Ousmen, Ahmad Conroy, Thierry Guillemin, Francis Velten, Michel Jolly, Damien Mercier, Mariette Causeret, Sylvain Cuisenier, Jean Graesslin, Olivier Hamidou, Zeinab Bonnetain, Franck Anota, Amelie Univ Hosp Besancon Methodol & Qual Life Unit Oncol Besancon France Univ Franche Comte INSERM UMR 1098 Besancon France Ctr Alexis Vautrin Med Oncol Dept Nancy France French Natl Platform Qual Life & Canc Besancon France Inserm CIC EC 1433 Nancy France CHU Clin Epidemiol & Evaluat Dept Nancy France Univ Strasbourg EA 3430 Fac Med Dept Epidemiol & Publ Hlth Strasbourg France Univ Hosp Reims Pole Rech Innovat Reims France Ctr Georges Francois Leclerc Dept Surg Dijon France Univ Hosp Reims Inst Mere Enfant Gynecol & Obstet Dept Reims France Aix Marseille Univ EA 3279 Publ Hlth Lab Marseille France

Background: An important challenge of the longitudinal analysis of health-related quality of life (HRQOL) is the potential occurrence of a Response Shift (RS) effect. While the impact of RS effect on the longitudinal analysis of HRQOL has already been studied, few studies have been conducted on its impact on the determination of the Minimal Important Difference (MID). This study aims to investigate the impact of the RS effect on the determination of the MID over time for each scale of both EORTC QLQ-C30 and QLQ-BR23 questionnaires in breast cancer patients. methods: Patients with breast cancer completed the EORTC QLQ-C30 and the EORTC QLQ-BR23 questionnaires at baseline (time of diagnosis;T0), three months (T1) and six months after surgery (T2). Four hospitals and care centers participated in this study: cancer centers of Dijon and Nancy, the university hospitals of Reims and Strasbourg At T1 and T2, patients were asked to evaluate their HRQOL change during the last 3 months using the Jaeschke transition question. They were also asked to assess retrospectively their HRQOL level of three months ago. The occurrence of the RS effect was explored using the then-test method and its impact on the determination of the MID by using the anchor-based method. Results: Between February 2006 and February 2008, 381 patients were included of mean age 58 years old (SD = 11). For patients who reported a deterioration of their HRQOL level at each follow-up, an increase of RS effect has been detected between T1 and T2 in 13/15 dimensions of QLQ-C30 questionnaire, and 4/7 dimensions of QLQ-BR23 questionnaire. In contrast, a decrease of the RS effect was observed in 8/15 dimensions of QLQ-C30 questionnaire and in 5/7 dimensions of QLQ-BR23 questionnaire in case of improvement. At T2, the MID became = 5 points when taking into account the RS effect in 10/15 dimensions of QLQ-C30 questionnaire and in 5/7 dimensions of QLQ-BR23 questionnaire. Conclusions: This study highlights that the RS

关键词： Health-related quality of life Response shift Minimal important difference Then-test anchor-based method

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