Does a Concise Patient-reported Outcome Measure Provide a Valid Measure of Physical Function for Cancer Patients After Lower Extremity Surgery?

IF 4.2 2区 医学 Q1 ORTHOPEDICS Clinical Orthopaedics and Related Research® Pub Date : 2024-10-04 DOI:10.1097/corr.0000000000003257
Theresa Nalty,Shalin S Patel,Justin E Bird,Valerae O Lewis,Patrick P Lin
{"title":"Does a Concise Patient-reported Outcome Measure Provide a Valid Measure of Physical Function for Cancer Patients After Lower Extremity Surgery?","authors":"Theresa Nalty,Shalin S Patel,Justin E Bird,Valerae O Lewis,Patrick P Lin","doi":"10.1097/corr.0000000000003257","DOIUrl":null,"url":null,"abstract":"BACKGROUND\r\nCurrent functional assessment tools for orthopaedic oncology are long surveys that contribute to patients' survey fatigue and yet lack the ability to discern meaningful differences in a patient population that is often mobile but unable to perform strenuous activities. We sought to determine whether a shorter, novel tool based on existing, validated surveys could better capture differences in a sample of orthopaedic oncology patients.\r\n\r\nQUESTIONS/PURPOSES\r\n(1) Can a concise fixed-item functional tool derived from the 50 items in the Toronto Extremity Salvage Score for the lower extremity (TESS LE) and the Lower Extremity Functional Scale (LEFS) demonstrate similar responsiveness in terms of sensitivity and specificity? (2) What is the precision and accuracy of the concise tool compared with the TESS LE and LEFS?\r\n\r\nMETHODS\r\nFunctional outcome data were collected and maintained in a longitudinally maintained database at a single institution. Patients were included in the study if (1) they had undergone a tumor excision or a nononcologic orthopaedic procedure (for example, arthroplasty for osteoarthritis) for a bone or soft tissue tumor affecting lower extremity function, and (2) they had completed the LEFS, TESS LE, and Patient-Reported Outcomes Measurement Information System (PROMIS) global health tool on at least two clinic visits. Between September 2014 and April 2022, we treated 14,234 patients for primary bone or soft tissue sarcoma, metastatic disease to bone, or orthopaedic sequelae of chronic cancer care. Approximately 6% (854 of 14,234) were excluded due to the need of a language translator. Approximately 2% (278 of 13,380) refused or were unable to participate. Seventy-two percent (9433 of 13,102) of the patients had an operation on a lower extremity. Of these, 4% (339 of 9433) of the patients completed the TESS LE, LEFS, and Item 3 of the PROMIS global health tool on ≥ 2 clinic visits. Of the patients in the current study, 49% (167 of 339) were women, and 27% (93 of 339) had metastatic carcinoma. Twelve percent (41 of 339) of the patients died before the end of the study period. Spearman rank-order correlation, principal component analysis (PCA), and item response theory (IRT) modeling identified 14 highly discriminating items from the TESS LE and LEFS. Multiple linear stepwise regression (MLSR) was performed with the dependent variable being the summary score of the 14 items derived from the TESS LE and LEFS and standardized to a percentage of 100. The beta coefficient from the MLSR was used to derive a weight for each of the 14 items. Evaluation of the model with 10 to 17 variables was performed to ensure that the model with the 14 items met the most criteria for fit with the PCA, the receiver operating characteristic (ROC) curve, and the IRT modeling criteria. The responsiveness (sensitivity and specificity) of the change scores in the shortened 14-item survey, the 30-item TESS LE, and the 20-item LEFS as compared with the dichotomized changes in Item 3 of the PROMIS global health tool was evaluated using ROCs. The concordance (accuracy and precision) of the 14 items derived from the LEFS and TESS LE was evaluated.\r\n\r\nRESULTS\r\nThe responsiveness (sensitivity and specificity) of the shortened 14-item survey, the TESS LE, and the LEFS to the criterion target of the PROMIS global health tool (Item 3) was similar, with areas under the curve (AUCs) ranging from 0.62 to 0.65 for the ROC curves. The responsiveness of the 14-item survey to the TESS LE showed sensitivity of 96% and specificity of 90%, with an AUC of 0.98 (p < 0.001). The responsiveness of the 14 items to the LEFS showed sensitivity of 95% and specificity of 86%, with an AUC of 0.96. The validity of the 14 items to the TESS LE was measured by concordance, with a precision of 0.98 and an accuracy of 0.97. Concordance of the 14 items to the LEFS showed a precision of 0.98 and accuracy of 0.83.\r\n\r\nCONCLUSION\r\nThe concise 14 items derived from patient-reported responses in the TESS LE and LEFS outcome measures showed similar responsiveness (sensitivity and specificity) as the original TESS LE and LEFS for cancer patients after lower extremity orthopaedic surgery performed for oncologic and nononcologic indications. The concise 14 items have a similar ability to the TESS LE and LEFS to tell the clinician or patient how they are functioning compared with other patients. These 14 items are shorter than the combined 50 items of the TESS LE and LEFS while retaining the capacity to describe a broad range of lower extremity function for orthopaedic oncology patients. We have named the 14-item survey the Lower Extremity Oncology Functional Assessment Tool.Level of Evidence Level II, diagnostic study.","PeriodicalId":10404,"journal":{"name":"Clinical Orthopaedics and Related Research®","volume":null,"pages":null},"PeriodicalIF":4.2000,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Orthopaedics and Related Research®","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/corr.0000000000003257","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ORTHOPEDICS","Score":null,"Total":0}
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Abstract

BACKGROUND Current functional assessment tools for orthopaedic oncology are long surveys that contribute to patients' survey fatigue and yet lack the ability to discern meaningful differences in a patient population that is often mobile but unable to perform strenuous activities. We sought to determine whether a shorter, novel tool based on existing, validated surveys could better capture differences in a sample of orthopaedic oncology patients. QUESTIONS/PURPOSES (1) Can a concise fixed-item functional tool derived from the 50 items in the Toronto Extremity Salvage Score for the lower extremity (TESS LE) and the Lower Extremity Functional Scale (LEFS) demonstrate similar responsiveness in terms of sensitivity and specificity? (2) What is the precision and accuracy of the concise tool compared with the TESS LE and LEFS? METHODS Functional outcome data were collected and maintained in a longitudinally maintained database at a single institution. Patients were included in the study if (1) they had undergone a tumor excision or a nononcologic orthopaedic procedure (for example, arthroplasty for osteoarthritis) for a bone or soft tissue tumor affecting lower extremity function, and (2) they had completed the LEFS, TESS LE, and Patient-Reported Outcomes Measurement Information System (PROMIS) global health tool on at least two clinic visits. Between September 2014 and April 2022, we treated 14,234 patients for primary bone or soft tissue sarcoma, metastatic disease to bone, or orthopaedic sequelae of chronic cancer care. Approximately 6% (854 of 14,234) were excluded due to the need of a language translator. Approximately 2% (278 of 13,380) refused or were unable to participate. Seventy-two percent (9433 of 13,102) of the patients had an operation on a lower extremity. Of these, 4% (339 of 9433) of the patients completed the TESS LE, LEFS, and Item 3 of the PROMIS global health tool on ≥ 2 clinic visits. Of the patients in the current study, 49% (167 of 339) were women, and 27% (93 of 339) had metastatic carcinoma. Twelve percent (41 of 339) of the patients died before the end of the study period. Spearman rank-order correlation, principal component analysis (PCA), and item response theory (IRT) modeling identified 14 highly discriminating items from the TESS LE and LEFS. Multiple linear stepwise regression (MLSR) was performed with the dependent variable being the summary score of the 14 items derived from the TESS LE and LEFS and standardized to a percentage of 100. The beta coefficient from the MLSR was used to derive a weight for each of the 14 items. Evaluation of the model with 10 to 17 variables was performed to ensure that the model with the 14 items met the most criteria for fit with the PCA, the receiver operating characteristic (ROC) curve, and the IRT modeling criteria. The responsiveness (sensitivity and specificity) of the change scores in the shortened 14-item survey, the 30-item TESS LE, and the 20-item LEFS as compared with the dichotomized changes in Item 3 of the PROMIS global health tool was evaluated using ROCs. The concordance (accuracy and precision) of the 14 items derived from the LEFS and TESS LE was evaluated. RESULTS The responsiveness (sensitivity and specificity) of the shortened 14-item survey, the TESS LE, and the LEFS to the criterion target of the PROMIS global health tool (Item 3) was similar, with areas under the curve (AUCs) ranging from 0.62 to 0.65 for the ROC curves. The responsiveness of the 14-item survey to the TESS LE showed sensitivity of 96% and specificity of 90%, with an AUC of 0.98 (p < 0.001). The responsiveness of the 14 items to the LEFS showed sensitivity of 95% and specificity of 86%, with an AUC of 0.96. The validity of the 14 items to the TESS LE was measured by concordance, with a precision of 0.98 and an accuracy of 0.97. Concordance of the 14 items to the LEFS showed a precision of 0.98 and accuracy of 0.83. CONCLUSION The concise 14 items derived from patient-reported responses in the TESS LE and LEFS outcome measures showed similar responsiveness (sensitivity and specificity) as the original TESS LE and LEFS for cancer patients after lower extremity orthopaedic surgery performed for oncologic and nononcologic indications. The concise 14 items have a similar ability to the TESS LE and LEFS to tell the clinician or patient how they are functioning compared with other patients. These 14 items are shorter than the combined 50 items of the TESS LE and LEFS while retaining the capacity to describe a broad range of lower extremity function for orthopaedic oncology patients. We have named the 14-item survey the Lower Extremity Oncology Functional Assessment Tool.Level of Evidence Level II, diagnostic study.
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简明患者报告结果测量法能否有效测量癌症患者下肢手术后的身体功能?
背景目前用于骨科肿瘤学的功能评估工具都是冗长的调查表,会造成患者的调查疲劳,而且在经常活动但无法进行剧烈活动的患者群体中,缺乏辨别有意义差异的能力。我们试图确定一种基于现有有效调查的简短、新型工具能否更好地捕捉骨科肿瘤患者样本中的差异。问题/提案(1)从多伦多下肢功能挽救评分(TESS LE)和下肢功能量表(LEFS)的 50 个项目中衍生出的简明固定项目功能工具能否在灵敏度和特异性方面表现出相似的反应能力?(2) 与 TESS LE 和 LEFS 相比,简明工具的精确性和准确性如何?符合以下条件的患者被纳入研究:(1)因骨或软组织肿瘤影响下肢功能而接受过肿瘤切除术或非肿瘤性骨科手术(如骨关节炎关节成形术);(2)至少在两次门诊中完成了LEFS、TESS LE和患者报告结果测量信息系统(PROMIS)全球健康工具。2014 年 9 月至 2022 年 4 月期间,我们共治疗了 14234 名原发性骨或软组织肉瘤、骨转移疾病或慢性癌症治疗骨科后遗症患者。约 6%(14234 人中的 854 人)因需要语言翻译而被排除在外。约 2%(13,380 人中的 278 人)拒绝或无法参与。72%的患者(13102 人中的 9433 人)曾在下肢做过手术。其中,4% 的患者(9433 人中的 339 人)在≥ 2 次门诊中完成了 TESS LE、LEFS 和 PROMIS 全球健康工具的第 3 项。在本次研究中,49% 的患者(339 人中的 167 人)为女性,27% 的患者(339 人中的 93 人)患有转移性癌症。12%的患者(339 例中的 41 例)在研究结束前死亡。通过斯皮尔曼秩相关、主成分分析(PCA)和项目反应理论(IRT)建模,从 TESS LE 和 LEFS 中确定了 14 个高区分度项目。进行了多元线性逐步回归(MLSR),因变量为来自 TESS LE 和 LEFS 的 14 个项目的总分,并标准化为 100%。MLSR 的贝塔系数用于为 14 个项目中的每个项目确定权重。对包含 10 至 17 个变量的模型进行评估,以确保包含 14 个项目的模型符合 PCA、接收者操作特征曲线(ROC)和 IRT 建模标准中的大多数拟合标准。与 PROMIS 全球健康工具第 3 项的二分法变化相比,使用 ROC 评估了缩短的 14 项调查、30 项 TESS LE 和 20 项 LEFS 的变化得分的响应性(灵敏度和特异性)。结果缩短的14项调查、TESS LE和LEFS对PROMIS全球健康工具标准目标(项目3)的响应性(灵敏度和特异性)相似,ROC曲线的曲线下面积(AUC)在0.62到0.65之间。14 项调查对 TESS LE 的响应性显示灵敏度为 96%,特异度为 90%,AUC 为 0.98(p < 0.001)。14 个调查项目对 LEFS 的反应灵敏度为 95%,特异度为 86%,AUC 为 0.96。14 个项目与 TESS LE 的有效性通过一致性来衡量,精确度为 0.98,准确度为 0.97。结论:对于因肿瘤和非肿瘤适应症接受下肢矫形手术后的癌症患者,从患者报告的 TESS LE 和 LEFS 结果测量中得出的简明 14 个项目显示出与原始 TESS LE 和 LEFS 相似的响应性(灵敏度和特异性)。简明的 14 个项目与 TESS LE 和 LEFS 具有相似的能力,可以告诉临床医生或患者,与其他患者相比,他们的功能如何。这 14 个项目比 TESS LE 和 LEFS 的总和 50 个项目要短,但仍能描述骨科肿瘤患者广泛的下肢功能。我们将这 14 个调查项目命名为 "下肢肿瘤功能评估工具"。
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来源期刊
CiteScore
7.00
自引率
11.90%
发文量
722
审稿时长
2.5 months
期刊介绍: Clinical Orthopaedics and Related Research® is a leading peer-reviewed journal devoted to the dissemination of new and important orthopaedic knowledge. CORR® brings readers the latest clinical and basic research, along with columns, commentaries, and interviews with authors.
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