Asian Pacific Journal of Cancer Prevention

  • 제16권18호
  • /
  • Pages.8573-8578
  • /
  • 2016
  • /
  • 1513-7368(pISSN)
  • /
  • 2476-762X(eISSN)
아시아태평양암예방학회 (Asian Pacific Journal of Cancer Prevention)
권호 표지
DOI QR코드

DOI QR Code

Development and Evaluation of a Patient-Reported Outcome (PRO) Scale for Breast Cancer

  • Zhang, Jun (Department of General Surgery, Nanjing Medical University Affiliated Cancer Hospital, Cancer Institute of Jiangsu Province) ;
  • Yao, Yu-Feng (Department of General Surgery, Nanjing Medical University Affiliated Cancer Hospital, Cancer Institute of Jiangsu Province) ;
  • Zha, Xiao-Ming (Department of Breast Surgery, The First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital) ;
  • Pan, Li-Qun (Department of Breast Surgery, The First Affiliated Hospital with Nanjing Medical University of TCM, Jiangsu Province Hospital of TCM) ;
  • Bian, Wei-He (Department of Breast Surgery, The First Affiliated Hospital with Nanjing Medical University of TCM, Jiangsu Province Hospital of TCM) ;
  • Tang, Jin Hai (Department of General Surgery, Nanjing Medical University Affiliated Cancer Hospital, Cancer Institute of Jiangsu Province)
  • 발행 : 2016.01.11
PDF 다운로드
⟨ 이전 논문 다음 논문 ⟩

초록

Background: This study was guided by principles of the theoretical system of evidence-based medicine. In particular, when searching for evidence of breast cancer, a measuring scale is an instrument for evaluating curative effects in accordance with the laws and characteristics of medicine and exploring the establishment of a system for medically assessing curative effects. At present, there exist few tools for evaluating curative effects. Patient-reported outcomes (PROs) refer to outcomes directly reported by patients (without input or explanations from doctors or other intermediaries) with respect to all aspects of their health. Data obtained from PROs provide evidence of treatment effects. Materials and Methods: In accordance with the tenets of theoretical medicine and ancient medical theory regarding breast cancer, principles for developing a PRO scale were established, and a theoretical model was developed and a literature review was performed, items from this pool were combined and split, and an initial scale was constructed. After a pilot survey and additional modifications, a pre-questionnaire scale was formed and used in a field investigation. After the application of statistical methods, the item pool was used to create a formal scale. The reliability, validity and feasibility of this formal scale were then assessed. Results: In a clinical investigation, 479 responses were recovered, with an acceptance rate of 95%. a combination of various methods was employed, and the items that were selected by all methods or more than half of the methods were employed in the questionnaire. In these cases, the screening methods were combined with certain features of the item, A total of four domains and 38 items were reserved. The reliability analysis indicated that the PRO scale was relatively reliable. Conclusions: Scientific assessment proved that the proposed scale exhibited good reliability and validity. This scale was readily accepted and could be used to assess the curative effects of medical therapy. However, given the limited scope of this investigation, the capacity for adapting this scale to incorporate other theories could not be determined.

키워드

참고문헌

  1. Arbuckle R, Abetz L, Durmer JS, et al (2010). Development of the pediatric restless legs syndrome severity scale (P-RLSSS): a patient-reported outcome measure of pediatric RLS symptoms and impact. Sleep Med, 11, 897-906. https://doi.org/10.1016/j.sleep.2010.03.016
  2. Anthoine E, Moret L, Regnault A, et al (2014). Sample size used to validate a scale : a review of publications on newlydeveloped patient reported outcomes measures. Health Qual Life Outcomes, 12, 176.
  3. Cella D, Yount S, Rothrock N (2007). The patient-reported outcomes measurement information system (promis) progress of an NIH roadmap cooperative group during its first Two Years. Medical Care, 45, 3-11. https://doi.org/10.1097/01.mlr.0000252647.00688.d2
  4. FDA (2006). Guidance for industry-patient-reported outcome measuresuse in medical product development to support labeling claims, draft guidance. Health Qual Life, 4, 79 https://doi.org/10.1186/1477-7525-4-79
  5. Fiscella K, Ransom S, Jean-Pierre P, et al (2011). Patient reported outcome measures suitable to assessment of patient navigation. Cancer, 117, 3603-17.
  6. Kanatas A, Velikova G, Roe B, et al (2012). Patient-reported outcomes in breast oncology: a review of validated outcome instruments. Tumori, 98, 678-88. https://doi.org/10.1177/030089161209800602
  7. Luquiens A, Whalley D, Crawford SR, et al (2015). Development of the alcohol quality of life scale (AQoLS): a new patientreported outcome measure to assesshealth-related quality of life in alcohol use disorder. Qual Life Res, 24, 1471-81. https://doi.org/10.1007/s11136-014-0865-7
  8. Mills RJ, Young CA, Pallant JF, et al (2010). Development of a patient reported outcome scale for fatigue in multiple sclerosis. The neurological fatigue index (NFI-MS). Health Qual Life Outcomes, 12, 22.
  9. McAllister M, Wood AM, Dunn G, et al (2011). The genetic counseling outcome scale: a new patient-reported outcome measure for clinical genetics services. Clin Genet, 79, 413-24. https://doi.org/10.1111/j.1399-0004.2011.01636.x
  10. Ohsumi S, Shimozuma K (2013). Current status and future perspectives of patient-reported outcome research in clinical trials for patients with breast cancer in Japan. Breast Cancer, 20, 296-301. https://doi.org/10.1007/s12282-012-0368-8
  11. Pusic AL, Klassen AF, Scott AM, et al (2009). Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg, 124, 345-53. https://doi.org/10.1097/PRS.0b013e3181aee807
  12. Pusic AL, Cemal Y, Albornoz C, et al (2013). Quality of life among breast cancer patients with lymphedema: a systematic review of patient-reported outcomeinstruments and outcomes. J Cancer Surviv, 7, 83-92. https://doi.org/10.1007/s11764-012-0247-5
  13. Pusic AL, Klassen AF, Scott AM, et al (2013). Development and psychometric evaluation of the FACE-Q satisfaction with appearance scale:a new patient-reported outcome instrument for facial aesthetics patients. Clin Plast Surg, 40, 249-60. https://doi.org/10.1016/j.cps.2012.12.001
  14. Zhao L, Chan K (2005). Patient-reported outcomes (PROs): an approach to evaluate treatment efficacy of chinese medicine or integrative medicine. CJIM, 11, 151-3.