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Minimal clinically important difference in postoperative recovery among patients with gastrointestinal cancer

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Abstract

Purpose

The minimal clinically important difference (MCID) based on patient-reported outcomes is the smallest outcome change sufficiently significant to influence management and is crucial to the design and interpretation of comparative effectiveness trials. The purpose of this study was to estimate the MCID for postoperative recovery metrics in gastrointestinal cancer patients.

Methods

This was a three-institutional cohort study. Participants were 219 patients scheduled for gastrointestinal cancer elective surgery. Body mass index (BMI), isometric knee extension torque (IKET), 6-min walk test (6 MWT), and Short-Form 36-Item Health Survey (SF-36) version 2 were evaluated 1–2 days prior to surgery (baseline) and 4 weeks after surgery. Patients received postoperative rehabilitative care from a physical therapist during hospitalization. The MCID used anchor-based methods. The anchor was a score on the SF-36 physical functioning subscale greater or lower than the average score of the general Japanese population.

Results

The receiver operating curve indicated a cutoff value on the 6 MWT of −7.8 m for clinically relevant decline (area under curve [AUC] = 0.67, 95% confidence interval [CI] = 0.599–0.741) or a 1.5% change. The cutoff value on the SF-36 role-physical subscale was −34.4 for clinically relevant decline (AUC = 0.691, 95% CI = 0.621–0.761) or a 36.6% decrease. No significant correlation was found between changes in BMI, IKET, and anchor.

Conclusion

Plausible MCIDs are present in patients with gastrointestinal cancer. These values can assist the interpretation of clinical trials and observation of the postoperative clinical course of gastrointestinal cancer surgery.

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Data availability

The authors have full control of all primary data and agree to allow the journal to review the data if required.

Code availability

Not applicable.

References

  1. Wilson IB, Cleary PD (1995) Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA 273(1):59–65

    Article  CAS  Google Scholar 

  2. Urbach DR, Harnish JL, Long G (2005) Short-term health-related quality of life after abdominal surgery: a conceptual framework. Surg Innov 12(3):243–247. https://doi.org/10.1177/155335060501200310

    Article  PubMed  Google Scholar 

  3. Bergman S, Feldman LS, Barkun JS (2006) Evaluating surgical outcomes. Surg Clin North Am 86(1):129–149. https://doi.org/10.1016/j.suc.2005.10.007

    Article  PubMed  Google Scholar 

  4. Urbach DR, Harnish JL, McIlroy JH, Streiner DL (2006) A measure of quality of life after abdominal surgery. Qual Life Res 15(6):1053–1061. https://doi.org/10.1007/s11136-006-0047-3

    Article  PubMed  Google Scholar 

  5. Quinten C, Coens C, Mauer M, Comte S, Sprangers MA, Cleeland C et al (2009) Baseline quality of life as a prognostic indicator of survival: a meta-analysis of individual patient data from EORTC clinical trials. Lancet Oncol 10(9):865–871. https://doi.org/10.1016/S1470-2045(09)70200-1

    Article  PubMed  Google Scholar 

  6. Shi Q, Smith TG, Michonski JD, Stein KD, Kaw C, Cleeland CS (2011) Symptom burden in cancer survivors 1 year after diagnosis: a report from the American Cancer Society’s Studies of Cancer Survivors. Cancer 117(12):2779–2790. https://doi.org/10.1002/cncr.26146

    Article  PubMed  Google Scholar 

  7. Wu HS, Harden JK (2015) Symptom burden and quality of life in survivorship: a review of the literature. Cancer Nurs 38(1):E29-54. https://doi.org/10.1097/NCC.0000000000000135

    Article  PubMed  Google Scholar 

  8. Antonescu I, Scott S, Tran TT, Mayo NE, Feldman LS (2014) Measuring postoperative recovery: what are clinically meaningful differences? Surgery 156(2):319–327. https://doi.org/10.1016/j.surg.2014.03.005

    Article  PubMed  Google Scholar 

  9. Granger CL, Holland AE, Gordon IR, Denehy L (2015) Minimal important difference of the 6-minute walk distance in lung cancer. Chronic Respir Dis 12(2):146–154. https://doi.org/10.1177/1479972315575715

    Article  Google Scholar 

  10. Crosby RD, Kolotkin RL, Williams GR (2003) Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol 56(5):395–407. https://doi.org/10.1016/s0895-4356(03)00044-1

    Article  PubMed  Google Scholar 

  11. Revicki D, Hays RD, Cella D, Sloan J (2008) Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol 61(2):102–109. https://doi.org/10.1016/j.jclinepi.2007.03.012

    Article  PubMed  Google Scholar 

  12. Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD et al (2009) The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg 250(2):187–196. https://doi.org/10.1097/SLA.0b013e3181b13ca2

    Article  PubMed  Google Scholar 

  13. Lundy JJ, Coons SJ, Wendel C, Hornbrook MC, Herrinton L, Grant M et al (2009) Exploring household income as a predictor of psychological well-being among long-term colorectal cancer survivors. Qual Life Res 18(2):157–161. https://doi.org/10.1007/s11136-008-9432-4

    Article  PubMed  PubMed Central  Google Scholar 

  14. Soerjomataram I, Thong MS, Ezzati M, Lamont EB, Nusselder WJ, van de Poll-Franse LV (2012) Most colorectal cancer survivors live a large proportion of their remaining life in good health. Cancer Causes Control 23(9):1421–1428. https://doi.org/10.1007/s10552-012-0010-2

    Article  PubMed  PubMed Central  Google Scholar 

  15. Trentham-Dietz A, Remington PL, Moinpour CM, Hampton JM, Sapp AL, Newcomb PA (2003) Health-related quality of life in female long-term colorectal cancer survivors. Oncologist 8(4):342–349. https://doi.org/10.1634/theoncologist.8-4-342

    Article  CAS  PubMed  Google Scholar 

  16. Hara T, Kogure E, Kubo A (2020) Does age of patients with gastrointestinal cancer impact postoperative physical function and quality of life? A prospective study using the new Japanese elderly standard. J Phys Ther Sci 32(12):833–838. https://doi.org/10.1589/jpts.32.833

    Article  PubMed  PubMed Central  Google Scholar 

  17. Lee J, Lee M, Hong S, Kim JY, Park H, Oh M et al (2015) Association between physical fitness, quality of life, and depression in stage II–III colorectal cancer survivors. Support Care Cancer 23(9):2569–2577. https://doi.org/10.1007/s00520-015-2615-y

    Article  PubMed  Google Scholar 

  18. Tomruk M, Karadibak D, Yavuzşen T, Akman T (2015) Predictors of functional capacity in colorectal cancer patients. Support Care Cancer 23(9):2747–2754. https://doi.org/10.1007/s00520-015-2639-3

    Article  PubMed  Google Scholar 

  19. ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories (2002) ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 166(1):111–117. https://doi.org/10.1164/ajrccm.166.1.at1102

    Article  Google Scholar 

  20. Fukuhara S, Suzukamo Y (2019) Manual of SF-36v2 Japanese version. iHope International Inc., Kyoto

  21. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ et al (1993) The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Nat Cancer Inst 85(5):365–376. https://doi.org/10.1093/jnci/85.5.365

    Article  CAS  PubMed  Google Scholar 

  22. Bergman B, Aaronson NK, Ahmedzai S, Kaasa Sullivan M (1994) The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials. EORTC Study Group on Quality of Life. Eur J Cancer 30A(5):635–642

    Article  CAS  Google Scholar 

  23. Akobeng AK (2007) Understanding diagnostic tests 3: receiver operating characteristic curves. Acta Paediatr 96(5):644–647. https://doi.org/10.1111/j.1651-2227.2006.00178.x

    Article  PubMed  Google Scholar 

  24. Puhan MA, Chandra D, Mosenifar Z, Ries A, Make B, Hansel NN et al (2011) The minimal important difference of exercise tests in severe COPD. Eur Respir J 37(4):784–790. https://doi.org/10.1183/09031936.00063810

    Article  CAS  PubMed  Google Scholar 

  25. Hosmer DW, Lemeshow S (2000) Applied logistic regression. Wiley Inc., New York

    Book  Google Scholar 

  26. Buffart LM, De Backer IC, Schep G, Vreugdenhil A, Brug J, Chinapaw MJ (2013) Fatigue mediates the relationship between physical fitness and quality of life in cancer survivors. J Sci Med Sport 16(2):99–104. https://doi.org/10.1016/j.jsams.2012.05.014

    Article  PubMed  Google Scholar 

  27. Karvinen KH, Courneya KS, North S, Venner P (2007) Associations between exercise and quality of life in bladder cancer survivors: a population-based study. Cancer Epidemiol Biomarkers Prev 16(5):984–990

    Article  Google Scholar 

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Acknowledgements

The authors are grateful to the rehabilitation staff at the International University of Health and Welfare, Mita Hospital; the International University of Health and Welfare Hospital; and the International University of Health and Welfare, Ichikawa Hospital, for their help with data collection.

Funding

This study was funded by Grants-in-Aid for Scientific Research (grant number: 19K19880) from the Japan Society for the Promotion of Science.

Author information

Authors and Affiliations

  1. Department of Physical Therapy, School of Health Science, International University of Health and Welfare, Tochigi, Japan

    Tsuyoshi Hara & Akira Kubo

  2. Rehabilitation Progress Center Incorporated, Tokyo, Japan

    Eisuke Kogure

  3. Division of Rehabilitation, International University of Health and Welfare Hospital, Tochigi, Japan

    Shinno Iijima

  4. Division of Rehabilitation, International University of Health and Welfare Ichikawa Hospital, Chiba, Japan

    Yasuhisa Fukawa

  5. Department of Rehabilitation Medicine, School of Medicine, International University of Health and Welfare, Chiba, Japan

    Wataru Kakuda

Authors
  1. Tsuyoshi Hara
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  2. Eisuke Kogure
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  3. Shinno Iijima
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  4. Yasuhisa Fukawa
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  5. Akira Kubo
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  6. Wataru Kakuda
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Contributions

All the authors contributed to the conception and design of the study. Tsuyoshi Hara, Eisuke Kogure, Shinno Iijima, Yasuhisa Fukawa, Akira Kubo, and Wataru Kakuda performed the material preparation, and data collection and analysis. Tsuyoshi Hara wrote the first draft of the manuscript. All the authors commented on the initial and subsequent drafts of the manuscript. Every author read and approved the final manuscript.

Corresponding author

Correspondence to Tsuyoshi Hara.

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Ethics approval

The study was approved by the Research Ethics Board of the International University of Health and Welfare, Otawara-shi, Tochigi, Japan (Registration no. 17-Io-202-2). All study procedures were conducted in accordance with ethical standards and the Declaration of Helsinki.

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All the participants were informed about the research and voluntarily agreed to participate.

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Not applicable

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The authors declare no competing interests.

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Hara, T., Kogure, E., Iijima, S. et al. Minimal clinically important difference in postoperative recovery among patients with gastrointestinal cancer. Support Care Cancer 30, 2197–2205 (2022). https://doi.org/10.1007/s00520-021-06632-9

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  • DOI: https://doi.org/10.1007/s00520-021-06632-9

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