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A patient-reported outcome instrument to assess the impact of oropharyngeal mucositis on health-related quality of life: a longitudinal psychometric evaluation

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Abstract

Goals of work

An oropharyngeal mucositis (OM)-specific health-related quality of life measure (OMQoL) has been developed to assess the impact of OM from the perspective of patients. The current paper describes the convergent, concurrent, and known-group validities and responsiveness in relation to clinical and health outcomes.

Materials and methods

A multicenter approach was used, and 137 patients treated with different cancer therapies completed the OMQoL and the European Organization for Research and Treatment of Cancer Quality of Life questionnaire [EORTC QLQ-C30 (Ch)] twice over a 4-week period or weekly over a 7-week period, along with concurrent measures of OM and its related symptoms.

Main results

The OM-related symptom scores correlated highly with the OMQoL, confirming its convergent validity (r = −0.724–−0.971, p < 0.01). Moderate correlations between the subscales of the OMQoL and EORTC QLQ-C30 (Ch) were indicative of good concurrent validity (r = 0.450–0.724, p < 0.01). The OMQoL was able to distinguish between patients with different severities of OM (p < 0.01) and types of cancer therapy (p < 0.01), providing evidence of good known-group validity. The changes in effects sizes corresponding to changes in OM curves indicate that the OMQoL is responsive to changes in OM status.

Conclusions

These findings suggest that the OMQoL has very good psychometric properties and can be used as a health-related quality of life assessment for cancer patients with OM. Much work is still needed in strengthening the psychometric qualities and interpretability of the OMQoL by demonstrating its ability to detect outcome changes over time.

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References

  1. Blijlevens NM, Donnelly JP, De Pauw (2000) Mucosal barrier injury: biology, pathology, clinical counterparts and consequences of intensive treatment for haematological malignancy: an overview. Bone Marrow Transplant 25:1269–1278 doi:10.1038/sj.bmt.1702447

    Article  PubMed  CAS  Google Scholar 

  2. Cheng KKF (2007) Oral mucositis & quality of life of Hong Kong Chinese patients with cancer therapy. Eur J Oncol Nurs 11:36–43 doi:10.1016/j.ejon.2006.03.004

    Article  PubMed  Google Scholar 

  3. Cheng KKF, Leung SF, Thompson DR et al (2007) A new measure of health-related quality of life for patients with oropharyngeal mucositis (OMQoL): development and preliminary psychometric evaluation. Cancer 109:2590–2599 doi:10.1002/cncr.22730

    Article  PubMed  Google Scholar 

  4. Chie WC, Hong RL, Lai CC et al (2003) Quality of life in patients of nasopharyngeal carcinoma: validation of the Taiwan Chinese version of the EORTC QLQ-C30 and the EORTC QLQ-H&N35. Qual Life Res 12:93–98 doi:10.1023/A:1022070220328

    Article  PubMed  CAS  Google Scholar 

  5. Cohen J (1992) A power primer. Psy Bull 1:155–159 doi:10.1037/0033-2909.112.1.155

    Article  Google Scholar 

  6. Dodd MJ, Dibble S, Miaskowski C et al (2001) A comparison of the affective state and quality of life of chemotherapy patients who do not and do not develop chemotherapy-induced oral mucositis. J Pain Symptom Manage 21:498–505 doi:10.1016/S0885-3924(01)00277-9

    Article  PubMed  CAS  Google Scholar 

  7. Duncan GG, Epstein JB, Dongsheng T et al (2005) Quality of life, mucositis, and xerostomia from radiotherapy for head and neck cancers: a report from the NCIC CTG HN2 randomized trial of an antimicrobial lozenge to prevent mucositis. Head Neck 27(5):421–428 doi:10.1002/hed.20162

    Article  PubMed  Google Scholar 

  8. Elting LS, Cooksley C, Chambers M et al (2003) The burdens of cancer therapy. Cancer 98:1521–1539 doi:10.1002/cncr.11671

    Article  Google Scholar 

  9. Engels JM, Diehr P (2003) Imputation of missing of longitudinal data: a comparison of methods. J Clin Epidemiol 56:968–976 doi:10.1016/S0895-4356(03)00170-7

    Article  PubMed  Google Scholar 

  10. EORTC (2001) EORTC QLQ-C30 scoring manual. Brussels

  11. Epstein JB, Beaumont JL, Gwede CK et al (2007) Longitudinal evaluation of the oral mucositis weekly questionnaire-head and neck cancer, a patient-reported outcomes questionnaire. Cancer 109:1914–1922 doi:10.1002/cncr.22620

    Article  PubMed  Google Scholar 

  12. Fayers PM, Machin D (2000) Quality of life: assessment, analysis and interpretation. Wiley, Chichester

    Google Scholar 

  13. Fletcher A, Gore S, Jones D et al (1992) Quality of life measures in health care II: design, analysis, and interpretation. BMJ 305:1145–1148

    PubMed  CAS  Google Scholar 

  14. Husted JA, Cook RJ, Farewell VT et al (2005) Methods for assessing responsiveness: a critical review and recommendations. J Clin Epidemiol 53:459–468 doi:10.1016/S0895-4356(99)00206-1

    Article  Google Scholar 

  15. Lipscomb J, Gotay CC, Snyder CF (2007) Patient-reported outcomes in cancer: A review of recent research and policy initiatives. CA Cancer J Clin 57:278–300

    Article  PubMed  Google Scholar 

  16. Matthews JNS, Altman DG, Campbell MJ et al (1990) Analysis of serial measurements in medical research. BMJ 300:230–235

    PubMed  CAS  Google Scholar 

  17. Mionpour CM, Denicoff AM, Bruner D et al (2007) Funding patient-reported outcomes in cancer clinical trials. J Clin Oncol 5:5100–5105 doi:10.1200/JCO.2007.11.5329

    Article  Google Scholar 

  18. Nunnally JC, Bernstein IH (1994) Psychometric theory (3rd edn). McGraw-Hill, New York

    Google Scholar 

  19. Osoba D, Zee B, Pater D et al (1994) Psychometric properties and responsiveness of the EORTC Quality of Life Questionnaire (QLQ-C30) in patients with breast, ovarian and lung cancer. Qual Life Res 3:353–364 doi:10.1007/BF00451727

    Article  PubMed  CAS  Google Scholar 

  20. Ramirez-Amador V, Esquivel-Pedraza L, Moha A et al (1996) Chemotherapy-associated oral mucosal lesions in patients with leukemia or lymphoma. Eur J Cancer Oral Oncol 32:322–337

    Article  Google Scholar 

  21. Revicki DA, Cella D, Hays RD et al (2006) Responsiveness and minimal important differences for patients reported outcomes. Health Qual Life Outcome 4:70 doi:10.1186/1477-7525-4-70

    Article  Google Scholar 

  22. Samsa G, Matchar DB, Dolor RJ et al (2004) A new instrument for measuring anticoagulation-related quality of life: development and preliminary validation. Health Qual Life Outcomes 2:22 doi:10.1186/1477-7525-2-22

    Article  PubMed  Google Scholar 

  23. Scully C, Sonis S, Diz PD (2006) Oral mucositis. Oral Dis 12:229–241 doi:10.1111/j.1601-0825.2006.01258.x

    Article  PubMed  CAS  Google Scholar 

  24. Shih A, Miaskowski C, Dodd JM et al (2003) Mechanisms for radiation-induced oral mucositis and the consequences. Cancer Nurs 26:222–229 doi:10.1097/00002820-200306000-00008

    Article  PubMed  Google Scholar 

  25. Sonis ST, Oster G, Fuchs H et al (2001) Oral mucositis and the clinical and economic outcomes of hematopoietic stem-cell transplantation. J Clin Oncol 19:2201–2205

    PubMed  CAS  Google Scholar 

  26. Spielberger R, Stiff P, Bensinger W et al (2004) Palifermin for oral mucositis after intensive therapy for hematologic cancers. N Engl J Med 351:2590–2598 doi:10.1056/NEJMoa040125

    Article  PubMed  CAS  Google Scholar 

  27. Stiff PJ, Emmanouilides C, Bensinger WI et al (2006) Palifermin reduces patient-reported mouth and throat soreness and improves patient functioning in the hematopoietic stem-cell. J Clin Oncol 24:5186–5193 doi:10.1200/JCO.2005.02.8340

    Article  PubMed  CAS  Google Scholar 

  28. Stiff PJ, Erder H, Bensinger WI et al (2006) Reliability and validity of a patient self-administered daily questionnaire to assess impact of oral mucositis (OM) on pain and daily functioning in patients undergoing autologous hematopoietic stem cell transplantation (HSCT). Bone Marrow Transplant 37:393–401 doi:10.1038/sj.bmt.1705250

    Article  PubMed  CAS  Google Scholar 

  29. Streiner DL, Norman GR (2003) Health measurement scales: a practical guide to their development and use (3rd edn). Oxford University Press, Oxford

    Google Scholar 

  30. Terwee CB, Dekker FW, Wiersinga WM et al (2003) On assessing responsiveness of health-related quality of life instruments: Guidelines for instrument evaluation. Qual Life Res 12:349–363 doi:10.1023/A:1023499322593

    Article  PubMed  CAS  Google Scholar 

  31. Trotte A, Bellm LA, Epstein JB et al (2003) Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiother Oncol 66:253–262 doi:10.1016/S0167-8140(02)00404-8

    Article  Google Scholar 

  32. World Health Organization (1979) Handbook for reporting results of cancer treatment. Offset Publication, Geneva

    Google Scholar 

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Acknowledgments

This study was supported by a grant from the Health, Welfare and Food Bureau of Hong Kong. We thank Alta Kan, WM Ling, and Maggie Tse for their efforts in coordinating the study in different sites and the physicians and nursing staff who were involved in various aspects of this study. Our special thanks go to all patients who gave their time to this study.

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Authors and Affiliations

  1. The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hongkong, Room732, Esther Lee Building, Shatin, New Territories, Hong Kong, China

    Karis K. F. Cheng

  2. Department of Clinical Oncology, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China

    S. F. Leung

  3. Division of Haematology, Medical Oncology and Bone Marrow transplantation, Faculty of Medicine, The University of Hong Kong, Hong Kong, China

    Raymond H. S. Liang

  4. Bone Marrow Transplantation Unit, Queen Mary Hospital, Hospital Authority, Hong Kong, China

    Josepha W. M. Tai

  5. Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong, China

    Rebecca M. W. Yeung

  6. Department of Health Sciences and Department of Cardiovascular Sciences, University of Leicester, Leicester, UK

    David R. Thompson

Authors
  1. Karis K. F. Cheng
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  2. S. F. Leung
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  3. Raymond H. S. Liang
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  4. Josepha W. M. Tai
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  5. Rebecca M. W. Yeung
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  6. David R. Thompson
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Corresponding author

Correspondence to Karis K. F. Cheng.

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Cheng, K.K.F., Leung, S.F., Liang, R.H.S. et al. A patient-reported outcome instrument to assess the impact of oropharyngeal mucositis on health-related quality of life: a longitudinal psychometric evaluation. Support Care Cancer 17, 389–398 (2009). https://doi.org/10.1007/s00520-008-0485-2

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