메뉴 건너뛰기




Volumn 10, Issue SUPPL. 2, 2007, Pages

Patient-reported outcome instrument selection: Designing a measurement strategy

Author keywords

Instrument selection; Patient reported outcomes; Validation

Indexed keywords

CONCEPTUAL FRAMEWORK; CONFERENCE PAPER; FOOD AND DRUG ADMINISTRATION; INSTRUMENT VALIDATION; OUTCOMES RESEARCH; PATIENT REPORTDE OUTCOMES; PRIORITY JOURNAL; RELIABILITY; UNITED STATES;

EID: 36048938965     PISSN: 10983015     EISSN: 15244733     Source Type: Journal    
DOI: 10.1111/j.1524-4733.2007.00270.x     Document Type: Conference Paper
Times cited : (80)

References (26)
  • 1
    • 36049030927 scopus 로고    scopus 로고
    • Food and Drug Administration. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims (DRAFT). US Department of Health and Human Services Food and Drug Administration; Center for Drug Evaluation and Research (CDER); Center for Biologics Evaluation and Research (CBER); Center for Devices and Radiological Health (CDRH), February 2006. Available from: [Accessed May 18, 2007].
    • Food and Drug Administration. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims (DRAFT). US Department of Health and Human Services Food and Drug Administration; Center for Drug Evaluation and Research (CDER); Center for Biologics Evaluation and Research (CBER); Center for Devices and Radiological Health (CDRH), February 2006. Available from: http://www.fda.gov/cder/guidance/ 5460dft.htm [Accessed May 18, 2007].
  • 2
    • 36048991575 scopus 로고    scopus 로고
    • Mayo/FDA Patient-Reported Outcome Meeting. Chantilly, VA, February 2006.
    • Mayo/FDA Patient-Reported Outcome Meeting. Chantilly, VA, February 2006.
  • 3
    • 36048955057 scopus 로고    scopus 로고
    • Patient reported outcomes: Conceptual issues
    • Mayo/FDA Patient-Reported Outcomes Consensus Writing Group.
    • Rothman M, Beltran P, Cappelleri JC, et al. Mayo/FDA Patient-Reported Outcomes Consensus Writing Group. Patient reported outcomes: conceptual issues. Value Health 2007 10 (Suppl. 2 S66 75.
    • (2007) Value Health , vol.10 , Issue.SUPPL. 2
    • Rothman, M.1    Beltran, P.2    Cappelleri, J.C.3
  • 4
    • 0033603814 scopus 로고    scopus 로고
    • Are surrogate markers adequate to assess cardiovascular disease drugs?
    • Temple R. Are surrogate markers adequate to assess cardiovascular disease drugs? JAMA 1999 282 : 790 5.
    • (1999) JAMA , vol.282 , pp. 790-795
    • Temple, R.1
  • 5
    • 0024852022 scopus 로고
    • Ascertaining the minimal clinically important difference
    • Jaeschke RJ, Singer J, Guyatt GH. Ascertaining the minimal clinically important difference. Control Clin Trial 1989 10 : 407 15.
    • (1989) Control Clin Trial , vol.10 , pp. 407-415
    • Jaeschke, R.J.1    Singer, J.2    Guyatt, G.H.3
  • 6
    • 0021807406 scopus 로고
    • When was a "negative" clinical trial big enough? How many patients you needed depends on what you found
    • Detsky AD, Sackett DL. When was a "negative" clinical trial big enough? How many patients you needed depends on what you found. Arch Intern Med 1985 145 : 709 12.
    • (1985) Arch Intern Med , vol.145 , pp. 709-712
    • Detsky, A.D.1    Sackett, D.L.2
  • 7
    • 0028000754 scopus 로고
    • Can there be a more patient-centered approach to determining clinically important effect sizes for randomized treatment trials?
    • Naylor CD, Llewellyn-Thomas HA. Can there be a more patient-centered approach to determining clinically important effect sizes for randomized treatment trials? J Clin Epid 1994 47 : 787 95.
    • (1994) J Clin Epid , vol.47 , pp. 787-795
    • Naylor, C.D.1    Llewellyn-Thomas, H.A.2
  • 8
    • 36048972378 scopus 로고    scopus 로고
    • Acceptable evidence for pharmaceutical advertising and labeling. DIA Workshop on Pharmacoeconomic and Quality of Life Labeling and Marketing Claims, October 2000.
    • Burke L. Acceptable evidence for pharmaceutical advertising and labeling. DIA Workshop on Pharmacoeconomic and Quality of Life Labeling and Marketing Claims, October 2000.
    • Burke, L.1
  • 9
    • 36048930205 scopus 로고    scopus 로고
    • A. guide for clinicians to compare the precision of health-related quality of life data relative to other clinical measures
    • (in press).
    • Hahn EA, Cella D, Chassany O, et al. A. guide for clinicians to compare the precision of health-related quality of life data relative to other clinical measures. Mayo Clinic Proc (in press).
    • Mayo Clinic Proc
    • Hahn, E.A.1    Cella, D.2    Chassany, O.3
  • 10
    • 0036171531 scopus 로고    scopus 로고
    • Regulatory issues for health-related quality of life - PhRMA Health Outcomes Committee Workshop, 1999
    • Santanello NC, Baker D, Cappelleri JC, et al. Regulatory issues for health-related quality of life - PhRMA Health Outcomes Committee Workshop, 1999. Value Health 2002 5 : 14 25.
    • (2002) Value Health , vol.5 , pp. 14-25
    • Santanello, N.C.1    Baker, D.2    Cappelleri, J.C.3
  • 11
    • 0032771192 scopus 로고    scopus 로고
    • A review of health-related quality-of-life concepts and measures for Parkinson's disease
    • Damiano AM, Snyder C, Strausser B, Willian MK. A review of health-related quality-of-life concepts and measures for Parkinson's disease. Qual Life Res 1999 8 : 235 43.
    • (1999) Qual Life Res , vol.8 , pp. 235-243
    • Damiano, A.M.1    Snyder, C.2    Strausser, B.3    Willian, M.K.4
  • 12
    • 0036112505 scopus 로고    scopus 로고
    • Assessing health status and quality-of-life instruments: Attributes and review criteria
    • Scientific Advisory Committee of the Medical Outcomes Trust.
    • Scientific Advisory Committee of the Medical Outcomes Trust. Assessing health status and quality-of-life instruments: attributes and review criteria. Qual Life Res 2002 11 : 193 205.
    • (2002) Qual Life Res , vol.11 , pp. 193-205
  • 13
    • 36049025508 scopus 로고    scopus 로고
    • What is sufficient evidence for the reliability and validity of patient-reported outcome measures?
    • Mayo/FDA Patient-Reported Outcomes Consensus Writing Group.
    • Frost MH, Reeve BB, Liepa AM, et al. Mayo/FDA Patient-Reported Outcomes Consensus Writing Group. What is sufficient evidence for the reliability and validity of patient-reported outcome measures? Value Health 2007 10 (Suppl. 2 S94 105.
    • (2007) Value Health , vol.10 , Issue.SUPPL. 2
    • Frost, M.H.1    Reeve, B.B.2    Liepa, A.M.3
  • 14
    • 36049024644 scopus 로고    scopus 로고
    • Food and Drug Administration. Advair information. Thomson's Physician Desk Reference
    • Food and Drug Administration. Advair information. Thomson's Physician Desk Reference, 2006.
    • (2006)
  • 15
    • 0033974505 scopus 로고    scopus 로고
    • Health-related quality of life and functional status of patients with rheumatoid arthritis randomly assigned to receive etanercept or placebo
    • Mathias SD, Colwell HH, Miller DP, et al. Health-related quality of life and functional status of patients with rheumatoid arthritis randomly assigned to receive etanercept or placebo. Clin Ther 2000 22 : 128 39.
    • (2000) Clin Ther , vol.22 , pp. 128-139
    • Mathias, S.D.1    Colwell, H.H.2    Miller, D.P.3
  • 16
    • 36048946415 scopus 로고    scopus 로고
    • Food and Drug Administration. Enbrel information. Physician Desk Reference (60th ed.) Thomson
    • Food and Drug Administration. Enbrel information. Physician Desk Reference (60th ed.) Thomson, 2006.
    • (2006)
  • 17
    • 36049026565 scopus 로고    scopus 로고
    • The bother assessment in skin conditions (BASC) scale: Redefining quality of life measures in dermatology. American Academy of Dermatology Annual Meeting
    • Caro G, Caro JJ, O'Brien JA, et al. The bother assessment in skin conditions (BASC) scale: Redefining quality of life measures in dermatology. American Academy of Dermatology Annual Meeting 1996.
    • (1996)
    • Caro, G.1    Caro, J.J.2    O'Brien, J.A.3
  • 18
    • 36048964279 scopus 로고    scopus 로고
    • Food and Drug Administration. Vaniqa information. Thompson's Physician Desk Reference
    • Food and Drug Administration. Vaniqa information. Thompson's Physician Desk Reference, 2006.
    • (2006)
  • 19
    • 0030926566 scopus 로고    scopus 로고
    • The international index of erectile function (IIEF): A multidimensional scale for assessment of erectile dysfunction
    • Rosen RC, Riley A, Wagner G, et al. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology 1997 49 : 822 30.
    • (1997) Urology , vol.49 , pp. 822-830
    • Rosen, R.C.1    Riley, A.2    Wagner, G.3
  • 20
    • 36048963661 scopus 로고    scopus 로고
    • Food and Drug Administration. Viagra information. Thomson's Physician Desk Reference
    • Food and Drug Administration. Viagra information. Thomson's Physician Desk Reference, 2006.
    • (2006)
  • 21
    • 36048932305 scopus 로고    scopus 로고
    • Patient-reported outcomes: Instrument development and selection issues
    • Mayo/FDA Patient-Reported Outcomes Consensus Writing Group.
    • Turner R, Quittner AL, Parasuraman BM, et al. Mayo/FDA Patient-Reported Outcomes Consensus Writing Group. Patient-reported outcomes: instrument development and selection issues. Value Health 2007 10 (Suppl. 2 S86 93.
    • (2007) Value Health , vol.10 , Issue.SUPPL. 2
    • Turner, R.1    Quittner, A.L.2    Parasuraman, B.M.3
  • 22
    • 0033844750 scopus 로고    scopus 로고
    • Evaluation of a measurement strategy for Parkinson's disease: Assessing patient health-related quality of life
    • Damiano AM, McGrath MM, Willian MK, et al. Evaluation of a measurement strategy for Parkinson's disease: assessing patient health-related quality of life. Qual Life Res 2000 9 : 87 100.
    • (2000) Qual Life Res , vol.9 , pp. 87-100
    • Damiano, A.M.1    McGrath, M.M.2    Willian, M.K.3
  • 23
    • 27944479014 scopus 로고    scopus 로고
    • Reflections on findings of the cancer outcomes measurement working group: Moving to the next phase
    • Gotay CC, Lipscomb J, Snyder CF. Reflections on findings of the cancer outcomes measurement working group: moving to the next phase. J Natl Cancer Inst 2005 97 : 1568 74.
    • (2005) J Natl Cancer Inst , vol.97 , pp. 1568-1574
    • Gotay, C.C.1    Lipscomb, J.2    Snyder, C.F.3
  • 24
    • 0034243790 scopus 로고    scopus 로고
    • Pain measurement: A comparison using horizontal and vertical visual analogue scales
    • Stephenson NL, Herman J. Pain measurement: a comparison using horizontal and vertical visual analogue scales. Appl Nurs Res 2000 13 : 157 8.
    • (2000) Appl Nurs Res , vol.13 , pp. 157-158
    • Stephenson, N.L.1    Herman, J.2
  • 25
    • 36049014744 scopus 로고    scopus 로고
    • SF-36® Health Survey update. Available from: [Accessed March 14, 2007].
    • Ware JE. SF-36® Health Survey update. Available from: http://www.sf-36.org/tools/sf36.shtml [Accessed March 14, 2007].
    • Ware, J.E.1
  • 26
    • 36049012777 scopus 로고    scopus 로고
    • The switch from paper. DIA Workshop on Benefits and Challenges with ePRO: Outcomes and Endpoints as We Emerge from the Long Age of Paper Methods, April 2005.
    • Guyatt G. The switch from paper. DIA Workshop on Benefits and Challenges with ePRO: Outcomes and Endpoints as We Emerge from the Long Age of Paper Methods, April 2005.
    • Guyatt, G.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.