메뉴 건너뛰기




Volumn 11, Issue 1, 2016, Pages

Management of Patient-Reported Outcome (PRO) Alerts in Clinical Trials: A Cross Sectional Survey.

Author keywords

[No Author keywords available]

Indexed keywords

CASE REPORT; CLINICAL RESEARCH; CLINICAL TRIAL; DOCTOR PATIENT RELATION; DOCUMENTATION; EXPOSURE; HUMAN; MANAGER; NURSE; PATIENT SAFETY; PERSONNEL; QUANTITATIVE STUDY; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; STAFF; THEMATIC ANALYSIS; VOLUNTEER; ADULT; AGED; CLINICAL TRIAL (TOPIC); CROSS-SECTIONAL STUDY; DISEASE MANAGEMENT; FEMALE; HEALTH CARE SURVEY; MALE; MIDDLE AGED; OUTCOME ASSESSMENT; PATIENT CARE; SELF REPORT; STATISTICS AND NUMERICAL DATA; YOUNG ADULT;

EID: 84958225940     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0144658     Document Type: Article
Times cited : (19)

References (24)
  • 1
    • 84902250286 scopus 로고
    • Patient-reported outcomes in randomised controlled trials of gynaecological cancers: Investigating methodological quality and impact on clinical decision-making
    • (Oxford, England Epub 2014/05/16 PMID: 24825114
    • Efficace F, Jacobs M, Pusic A, Greimel E, Piciocchi A, Kieffer JM, et al. Patient-reported outcomes in randomised controlled trials of gynaecological cancers: Investigating methodological quality and impact on clinical decision-making. European journal of cancer (Oxford, England: 1990). 2014. Epub 2014/05/16. doi: 10.1016/j.ejca.2014.04.005 PMID: 24825114.
    • (1990) European Journal of Cancer , vol.2014
    • Efficace, F.1    Jacobs, M.2    Pusic, A.3    Greimel, E.4    Piciocchi, A.5    Kieffer, J.M.6
  • 2
    • 0037950627 scopus 로고    scopus 로고
    • Cancer patients' preferences for communicating clinical trial quality of life information: A qualitative study
    • PMID: 12797712
    • Brundage M, Leis A, Bezjak A, Feldman-Stewart D, Degner L, Velji K, et al. Cancer patients' preferences for communicating clinical trial quality of life information: A qualitative study. Quality of Life Research. 2003; 12:395-404. PMID: 12797712
    • (2003) Quality of Life Research , vol.12 , pp. 395-404
    • Brundage, M.1    Leis, A.2    Bezjak, A.3    Feldman-Stewart, D.4    Degner, L.5    Velji, K.6
  • 3
    • 0037265996 scopus 로고    scopus 로고
    • Provision of individualized information to men and their partners to facilitate treatment decision making in prostate cancer
    • PMID: 12515988
    • Joyce Davidson B, Goldenberg L, Gleave ME, Degner L. Provision of Individualized Information to Men and Their Partners to Facilitate Treatment Decision Making in Prostate Cancer. Oncology Nursing Forum. 2003; 30(1):107-14. PMID: 12515988
    • (2003) Oncology Nursing Forum , vol.30 , Issue.1 , pp. 107-114
    • Joyce Davidson, B.1    Goldenberg, L.2    Gleave, M.E.3    Degner, L.4
  • 4
    • 84867068685 scopus 로고    scopus 로고
    • Implementing patient-reported outcomes assessment in clinical practice: A review of the options and considerations
    • PMID: 22048932
    • Snyder CF, Aaronson N, Chouchair AK, Elliott TE, Greenhalgh J, Halyard MY, et al. Implementing patient-reported outcomes assessment in clinical practice: a review of the options and considerations. Quality of Life Research. 2011; 21(8):1305-14. doi: 10.1007/s11136-011-0054-x PMID: 22048932
    • (2011) Quality of Life Research , vol.21 , Issue.8 , pp. 1305-1314
    • Snyder, C.F.1    Aaronson, N.2    Chouchair, A.K.3    Elliott, T.E.4    Greenhalgh, J.5    Halyard, M.Y.6
  • 5
    • 84870062280 scopus 로고    scopus 로고
    • The use of patientreported outcomes (pro) within comparative effectiveness research: Implications for clinical practice and health care policy
    • PMID 22922434
    • Ahmed S, Berzon RA, Revicki DA, Lenderking WR, Moinpour CM, Basch E, et al. The Use of Patientreported Outcomes (PRO) Within Comparative Effectiveness Research: Implications for Clinical Practice and Health Care Policy. Medical Care. 2012; 50(12):1060-70. doi: 10.1097/MLR. 0b013e318268aaff PMID: 22922434
    • (2012) Medical Care , vol.50 , Issue.12 , pp. 1060-1070
    • Ahmed, S.1    Berzon, R.A.2    Revicki, D.A.3    Lenderking, W.R.4    Moinpour, C.M.5    Basch, E.6
  • 6
    • 84875679183 scopus 로고    scopus 로고
    • Development of a guidance for including patient-reported outcomes (pros) in post-Approval clinical trials of oncology drugs for comparative effectiveness research (cer
    • PMID: 70490494
    • Basch EM, Abernethy A, Mullins CD, Tiglao MR, Tunis SR. Development of a guidance for including patient-reported outcomes (PROS) in post-Approval clinical trials of oncology drugs for comparative effectiveness research (CER). Value in Health. 2011; 14 (3):A10. PMID: 70490494.
    • (2011) Value in Health , vol.14 , Issue.3 , pp. A10
    • Basch, E.M.1    Abernethy, A.2    Mullins, C.D.3    Tiglao, M.R.4    Tunis, S.R.5
  • 7
    • 84874334842 scopus 로고    scopus 로고
    • Patient reported outcome measures could help transform healthcare
    • PMID: 23358487
    • Black N. Patient reported outcome measures could help transform healthcare. BMJ. 2013; 346:f167. doi: 10.1136/bmj.f167 PMID: 23358487
    • (2013) BMJ , vol.346 , pp. f167
    • Black, N.1
  • 8
    • 41649088640 scopus 로고    scopus 로고
    • The prognostic significance of patient-reported outcomes in cancer clinical trials
    • PMID 18227528
    • Gotay CC, Kawamoto CT, Bottomley A, Efficace F. The prognostic significance of patient-reported outcomes in cancer clinical trials. Journal of Clinical Oncology. 2008; 26(8):1355-63. doi: 10.1200/JCO. 2007.13.3439 PMID: 18227528
    • (2008) Journal of Clinical Oncology , vol.26 , Issue.8 , pp. 1355-1363
    • Gotay, C.C.1    Kawamoto, C.T.2    Bottomley, A.3    Efficace, F.4
  • 9
    • 84884623034 scopus 로고    scopus 로고
    • Patient-reported outcome alerts ethical and logistical considerations in clinical trials
    • PMID: 24065005
    • Kyte DG, Draper H, Calvert M. Patient-Reported Outcome Alerts: Ethical and Logistical Considerations in Clinical Trials. JAMA. 2013; 310(12):1229-30. doi: 10.1001/jama.2013.277222 PMID: 24065005
    • (2013) JAMA , vol.310 , Issue.12 , pp. 1229-1230
    • Kyte, D.G.1    Draper, H.2    Calvert, M.3
  • 10
    • 84885032561 scopus 로고    scopus 로고
    • Inconsistencies in quality of life data collection in clinical trials: A potential source of bias? Interviews with research nurses and trialists
    • Epub 2013/10/15 PMID: 24124580; PubMed Central PMCID: PMCPmc3790726
    • Kyte D, Ives J, Draper H, Keeley T, Calvert M. Inconsistencies in quality of life data collection in clinical trials: a potential source of bias? Interviews with research nurses and trialists. PLoS One. 2013; 8(10): e76625. Epub 2013/10/15. doi: 10.1371/journal.pone.0076625 PMID: 24124580; PubMed Central PMCID: PMCPmc3790726.
    • (2013) PLoS One , vol.8 , Issue.10 , pp. e76625
    • Kyte, D.1    Ives, J.2    Draper, H.3    Keeley, T.4    Calvert, M.5
  • 12
    • 84884623034 scopus 로고    scopus 로고
    • Patient-reported outcome alerts: Ethical and logistical considerations in clinical trials
    • Epub 2013/09/26 PMID: 24065005
    • Kyte D, Draper H, Calvert M. Patient-reported outcome alerts: ethical and logistical considerations in clinical trials. JAMA. 2013; 310(12):1229-30. Epub 2013/09/26. doi: 10.1001/jama.2013.277222 PMID: 24065005.
    • (2013) JAMA , vol.310 , Issue.12 , pp. 1229-1230
    • Kyte, D.1    Draper, H.2    Calvert, M.3
  • 13
    • 27844518793 scopus 로고    scopus 로고
    • Three approaches to qualitative content analysis
    • Epub 2005/10/06 PMID: 16204405
    • Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qualitative health research. 2005; 15(9):1277-88. Epub 2005/10/06. doi: 10.1177/1049732305276687 PMID: 16204405.
    • (2005) Qualitative Health Research , vol.15 , Issue.9 , pp. 1277-1288
    • Hsieh, H.F.1    Shannon, S.E.2
  • 14
    • 84925425625 scopus 로고    scopus 로고
    • Putting patients at the heart of health-care research
    • Epub 2015/03/24 PMID: 25797557
    • Calvert M, Kyte D, von Hildebrand M, King M, Moher D. Putting patients at the heart of health-care research. Lancet. 2015; 385(9973):1073-4. Epub 2015/03/24. doi: 10.1016/s0140-6736(15)60599-2 PMID: 25797557.
    • (2015) Lancet , vol.385 , Issue.9973 , pp. 1073-1074
    • Calvert, M.1    Kyte, D.2    Von Hildebrand, M.3    King, M.4    Moher, D.5
  • 15
    • 84958165484 scopus 로고    scopus 로고
    • Directive 2001/20/ec of the european parliament and of the council of 4 April 2001on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
    • EU
    • EU. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. The European Parliament and the Council of the European Union. 2001.
    • (2001) The European Parliament and the Council of the European Union
  • 16
    • 84958172380 scopus 로고    scopus 로고
    • Directive 2005/28/ec of 8 April 2005: Laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
    • EU
    • EU. Directive 2005/28/EC of 8 April 2005: laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. Official Journal of the European Union; 2005.
    • (2005) Official Journal of the European Union
  • 21
    • 0031691551 scopus 로고    scopus 로고
    • Estimating the effect of treatment on quality of life in the presence of missing data due to drop-out and death
    • Epub 1998/09/16. PMID: 9737138
    • Raboud JM, Singer J, Thorne A, Schechter MT, Shafran SD. Estimating the effect of treatment on quality of life in the presence of missing data due to drop-out and death. Qual Life Res. 1998; 7(6):487-94. Epub 1998/09/16. PMID: 9737138.
    • (1998) Qual Life Res , vol.7 , Issue.6 , pp. 487-494
    • Raboud, J.M.1    Singer, J.2    Thorne, A.3    Schechter, M.T.4    Shafran, S.D.5
  • 22
    • 80051691888 scopus 로고    scopus 로고
    • Clinician-trialist rounds 5. Cointervention bias ? How to diagnose it in their trial and prevent it in yours
    • PMID: 21835863
    • Sackett DL. Clinician-trialist rounds: 5. Cointervention bias ? how to diagnose it in their trial and prevent it in yours. Clinical Trials. 2011; 8:440-2. doi: 10.1177/1740774511410995 PMID: 21835863
    • (2011) Clinical Trials , vol.8 , pp. 440-442
    • Sackett, D.L.1
  • 23
    • 84908139094 scopus 로고    scopus 로고
    • Systematic evaluation of the patient-reported outcome (pro) content of clinical trial protocols
    • PMID: 25333349
    • Kyte D, Duffy H, Fletcher B, Gheorghe A, Mercieca-Bebber R, King M, et al. Systematic Evaluation of the Patient-Reported Outcome (PRO) Content of Clinical Trial Protocols. PLoS ONE. 2014; 9(10): e110229. doi: 10.1371/journal.pone.0110229 PMID: 25333349
    • (2014) PLoS ONE , vol.9 , Issue.10 , pp. e110229
    • Kyte, D.1    Duffy, H.2    Fletcher, B.3    Gheorghe, A.4    Mercieca-Bebber, R.5    King, M.6
  • 24
    • 84875673156 scopus 로고    scopus 로고
    • Patient reported outcomes (pros) in clinical trials: Is 'in-trial' guidance lacking? A systematic review
    • PMID: 23560103
    • Kyte D, Draper H, Ives J, Liles C, Gheorghe A, Calvert M. Patient Reported Outcomes (PROs) in Clinical Trials: Is 'In-Trial' Guidance Lacking? A Systematic Review. PLoS ONE. 2013; 8(4): e60684. doi: 10.1371/journal.pone.0060684 PMID: 23560103
    • (2013) PLoS ONE , vol.8 , Issue.4 , pp. e60684
    • Kyte, D.1    Draper, H.2    Ives, J.3    Liles, C.4    Gheorghe, A.5    Calvert, M.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.