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Du Débat Public « Le patient acteur de sa propre surveillance ».

Patient Reported Outcomes : Références bibliographiques

1          Patrick DL, Burke LB, Powers JH et al. Patient-reported outcomes to support medical product labeling claims: FDA perspective. Value Health 2007; 10 Suppl 2: S125-137.

2          Porter ME, Larsson S, Lee TH. Standardizing Patient Outcomes Measurement. N Engl J Med 2016; 374: 504–506.

3          U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes 2006; 4: 79.

4          Briançon S, Kessler M. Qualité de vie et maladies rénales chroniques. http://www.jle.com/fr/ouvrages/e-docs/qualite_de_vie_et_maladies_renales_chroniques_278626/ouvrage.phtml (accessed 9 Jun2017).

5          Vodicka E, Kim K, Devine EB, Gnanasakthy A, Scoggins JF, Patrick DL. Inclusion of patient-reported outcome measures in registered clinical trials: Evidence from ClinicalTrials.gov (2007-2013). Contemp Clin Trials 2015; 43: 1–9.

6          Basch E. The missing voice of patients in drug-safety reporting. N Engl J Med 2010; 362: 865–869.

7          Trotti A, Colevas AD, Setser A, Basch E. Patient-reported outcomes and the evolution of adverse event reporting in oncology. J Clin Oncol 2007; 25: 5121–5127.

8          Gravis G, Marino P, Joly F et al. Patients’ self-assessment versus investigators’ evaluation in a phase III trial in non-castrate metastatic prostate cancer (GETUG-AFU 15). European Journal of Cancer 2014; 50: 953–962.

9          Montemurro F, Mittica G, Cagnazzo C et al. Self-evaluation of Adjuvant Chemotherapy-Related Adverse Effects by Patients With Breast Cancer. JAMA Oncol 2016; 2: 445–452.

10        Di Maio M, Gallo C, Leighl NB et al. Symptomatic toxicities experienced during anticancer treatment: agreement between patient and physician reporting in three randomized trials. J Clin Oncol 2015; 33: 910–915.

11        Petersen MA, Larsen H, Pedersen L, Sonne N, Groenvold M. Assessing health-related quality of life in palliative care: comparing patient and physician assessments. Eur J Cancer 2006; 42: 1159–1166.

12        Fromme EK, Eilers KM, Mori M, Hsieh Y-C, Beer TM. How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30. J Clin Oncol 2004; 22: 3485–3490.

13        Basch E, Reeve BB, Mitchell SA et al. Development of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst 2014; 106. doi:10.1093/jnci/dju244.

14        Dueck AC, Mendoza TR, Mitchell SA et al. Validity and Reliability of the US National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). JAMA Oncol 2015; 1: 1051–1059.

15        Reeve BB, Mitchell SA, Dueck AC et al. Recommended Patient-Reported Core Set of Symptoms to Measure in Adult Cancer Treatment Trials. J Natl Cancer Inst 2014; 106. doi:10.1093/jnci/dju129.

16        Macquart-Moulin G, Viens P, Bouscary ML et al. Discordance between physicians’ estimations and breast cancer patients’ self-assessment of side-effects of chemotherapy: an issue for quality of care. Br J Cancer 1997; 76: 1640–1645.

17        Laugsand EA, Sprangers MAG, Bjordal K, Skorpen F, Kaasa S, Klepstad P. Health care providers underestimate symptom intensities of cancer patients: a multicenter European study. Health Qual Life Outcomes 2010; 8: 104.

18        Black N. Patient reported outcome measures could help transform healthcare. BMJ 2013; 346: f167.

19        Duran S, Spire B, Raffi F et al. Self-reported symptoms after initiation of a protease inhibitor in HIV-infected patients and their impact on adherence to HAART. HIV Clin Trials 2001; 2: 38–45.

20        Spire B, Duran S, Souville M et al. Adherence to highly active antiretroviral therapies (HAART) in HIV-infected patients: from a predictive to a dynamic approach. Soc Sci Med 2002; 54: 1481–1496.

21        Collette L, van Andel G, Bottomley A et al. Is baseline quality of life useful for predicting survival with hormone-refractory prostate cancer? A pooled analysis of three studies of the European Organisation for Research and Treatment of Cancer Genitourinary Group. J Clin Oncol 2004; 22: 3877–3885.

22        Efficace F, Bottomley A, Smit EF et al. Is a patient’s self-reported health-related quality of life a prognostic factor for survival in non-small-cell lung cancer patients? A multivariate analysis of prognostic factors of EORTC study 08975. Ann Oncol 2006; 17: 1698–1704.

23        Park SH, Cho MS, Kim YS et al. Self-reported health-related quality of life predicts survival for patients with advanced gastric cancer treated with first-line chemotherapy. Qual Life Res 2008; 17: 207–214.

24        Bonnetain F, Paoletti X, Collette S et al. Quality of life as a prognostic factor of overall survival in patients with advanced hepatocellular carcinoma: results from two French clinical trials. Qual Life Res 2008; 17: 831–843.

25        Diouf M, Filleron T, Barbare J-C et al. The added value of quality of life (QoL) for prognosis of overall survival in patients with palliative hepatocellular carcinoma. J Hepatol 2013; 58: 509–521.

26        Velikova G, Booth L, Smith AB et al. Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol 2004; 22: 714–724.

27        Basch E, Deal AM, Dueck AC et al. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA 2017. doi:10.1001/jama.2017.7156