Leevi A Toivonen, Jenna L C Laurén, Hannu Kautiainen, Arja H Häkkinen, Marko H Neva
{"title":"腰椎融合术后 10 年最小重要变化和患者可接受症状状态的异质性。","authors":"Leevi A Toivonen, Jenna L C Laurén, Hannu Kautiainen, Arja H Häkkinen, Marko H Neva","doi":"10.1097/BRS.0000000000005065","DOIUrl":null,"url":null,"abstract":"<p><strong>Study design: </strong>Cohort study.</p><p><strong>Objective: </strong>To evaluate heterogeneity (fluctuation) in minimal important change (MIC) and patient-acceptable symptom state (PASS) for patient-reported outcomes (PROMs) through 10 years after lumbar fusion.</p><p><strong>Summary of background data: </strong>PROMs have become key determinants in spine surgery outcomes studies. MIC and PASS were established to aid PROM interpretations. However, their long-term stability has not yet been reported.</p><p><strong>Methods: </strong>A consecutive series of elective lumbar fusions were followed up using the Oswestry Disability Index (ODI) and Visual Analogue Scale (VAS) for pain. Improvement was rated by a 4-point Likert scale into \"improved\" or \"nonimproved.\" Satisfaction-to-treatment was rated by the patients' willingness to undergo surgery again. Receiver operating characteristics (ROC) curve analysis estimated MIC (95% confidence interval, CI) as the PROM change that best predicted improvement at distinct time-points. PASS (CI) was estimated as the lowest PROM score at which the patients were still satisfied. Heterogeneity across thresholds was evaluated using the DeLong algorithm.</p><p><strong>Results: </strong>MIC for ODI represented heterogeneity across 10 years, ranging from -21 (-24 to -16) at two years to -8 (-7 to -4) at five years, P<0.001. The areas under the ROC curves (AUCs) (0.79 to 0.85) indicated acceptable to excellent discrimination. Heterogeneity was not significant in the MICs for the pain scores. At one year, MIC for back pain was -24 (-38 to -15), AUC 0.77, and for leg pain, it was -26 (-44 to -8), AUC 0.78. No significant heterogeneity was observed in 10-year PASS scores. At 1-year, PASS for ODI was 22 (15 to 29), AUC 0.85. Similarly, the one-year PASS for back pain was 38 (20 to 56), AUC 0.81, and for leg pain, it was 49 (26 to 72), AUC 0.81.</p><p><strong>Conclusions: </strong>MIC for ODI fluctuated over 10 years after lumbar fusions. PASS values for all PROMs seemed most stable over time. Caution is needed when generic MIC values are used in long-term studies.</p><p><strong>Level of evidence: </strong>Level III.</p>","PeriodicalId":22193,"journal":{"name":"Spine","volume":" ","pages":"46-52"},"PeriodicalIF":2.6000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11627302/pdf/","citationCount":"0","resultStr":"{\"title\":\"Ten-Year Heterogeneity of Minimal Important Change and Patient Acceptable Symptom State After Lumbar Fusions.\",\"authors\":\"Leevi A Toivonen, Jenna L C Laurén, Hannu Kautiainen, Arja H Häkkinen, Marko H Neva\",\"doi\":\"10.1097/BRS.0000000000005065\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Study design: </strong>Cohort study.</p><p><strong>Objective: </strong>To evaluate heterogeneity (fluctuation) in minimal important change (MIC) and patient-acceptable symptom state (PASS) for patient-reported outcomes (PROMs) through 10 years after lumbar fusion.</p><p><strong>Summary of background data: </strong>PROMs have become key determinants in spine surgery outcomes studies. MIC and PASS were established to aid PROM interpretations. However, their long-term stability has not yet been reported.</p><p><strong>Methods: </strong>A consecutive series of elective lumbar fusions were followed up using the Oswestry Disability Index (ODI) and Visual Analogue Scale (VAS) for pain. Improvement was rated by a 4-point Likert scale into \\\"improved\\\" or \\\"nonimproved.\\\" Satisfaction-to-treatment was rated by the patients' willingness to undergo surgery again. Receiver operating characteristics (ROC) curve analysis estimated MIC (95% confidence interval, CI) as the PROM change that best predicted improvement at distinct time-points. PASS (CI) was estimated as the lowest PROM score at which the patients were still satisfied. Heterogeneity across thresholds was evaluated using the DeLong algorithm.</p><p><strong>Results: </strong>MIC for ODI represented heterogeneity across 10 years, ranging from -21 (-24 to -16) at two years to -8 (-7 to -4) at five years, P<0.001. The areas under the ROC curves (AUCs) (0.79 to 0.85) indicated acceptable to excellent discrimination. Heterogeneity was not significant in the MICs for the pain scores. At one year, MIC for back pain was -24 (-38 to -15), AUC 0.77, and for leg pain, it was -26 (-44 to -8), AUC 0.78. No significant heterogeneity was observed in 10-year PASS scores. At 1-year, PASS for ODI was 22 (15 to 29), AUC 0.85. Similarly, the one-year PASS for back pain was 38 (20 to 56), AUC 0.81, and for leg pain, it was 49 (26 to 72), AUC 0.81.</p><p><strong>Conclusions: </strong>MIC for ODI fluctuated over 10 years after lumbar fusions. PASS values for all PROMs seemed most stable over time. Caution is needed when generic MIC values are used in long-term studies.</p><p><strong>Level of evidence: </strong>Level III.</p>\",\"PeriodicalId\":22193,\"journal\":{\"name\":\"Spine\",\"volume\":\" \",\"pages\":\"46-52\"},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2025-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11627302/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Spine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/BRS.0000000000005065\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/6/13 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Spine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/BRS.0000000000005065","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/6/13 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
Ten-Year Heterogeneity of Minimal Important Change and Patient Acceptable Symptom State After Lumbar Fusions.
Study design: Cohort study.
Objective: To evaluate heterogeneity (fluctuation) in minimal important change (MIC) and patient-acceptable symptom state (PASS) for patient-reported outcomes (PROMs) through 10 years after lumbar fusion.
Summary of background data: PROMs have become key determinants in spine surgery outcomes studies. MIC and PASS were established to aid PROM interpretations. However, their long-term stability has not yet been reported.
Methods: A consecutive series of elective lumbar fusions were followed up using the Oswestry Disability Index (ODI) and Visual Analogue Scale (VAS) for pain. Improvement was rated by a 4-point Likert scale into "improved" or "nonimproved." Satisfaction-to-treatment was rated by the patients' willingness to undergo surgery again. Receiver operating characteristics (ROC) curve analysis estimated MIC (95% confidence interval, CI) as the PROM change that best predicted improvement at distinct time-points. PASS (CI) was estimated as the lowest PROM score at which the patients were still satisfied. Heterogeneity across thresholds was evaluated using the DeLong algorithm.
Results: MIC for ODI represented heterogeneity across 10 years, ranging from -21 (-24 to -16) at two years to -8 (-7 to -4) at five years, P<0.001. The areas under the ROC curves (AUCs) (0.79 to 0.85) indicated acceptable to excellent discrimination. Heterogeneity was not significant in the MICs for the pain scores. At one year, MIC for back pain was -24 (-38 to -15), AUC 0.77, and for leg pain, it was -26 (-44 to -8), AUC 0.78. No significant heterogeneity was observed in 10-year PASS scores. At 1-year, PASS for ODI was 22 (15 to 29), AUC 0.85. Similarly, the one-year PASS for back pain was 38 (20 to 56), AUC 0.81, and for leg pain, it was 49 (26 to 72), AUC 0.81.
Conclusions: MIC for ODI fluctuated over 10 years after lumbar fusions. PASS values for all PROMs seemed most stable over time. Caution is needed when generic MIC values are used in long-term studies.
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Recognized internationally as the leading journal in its field, Spine is an international, peer-reviewed, bi-weekly periodical that considers for publication original articles in the field of Spine. It is the leading subspecialty journal for the treatment of spinal disorders. Only original papers are considered for publication with the understanding that they are contributed solely to Spine. The Journal does not publish articles reporting material that has been reported at length elsewhere.
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