Entity

Time filter

Source Type


Calvert M.,University of Birmingham | Brundage M.,Queens University | Jacobsen P.B.,H. Lee Moffitt Cancer Center and Research Institute | Schunemann H.J.,McMaster University | Efficace F.,Health Outcomes Research Unit
Health and Quality of Life Outcomes | Year: 2013

To inform clinical guidelines and patient care we need high quality evidence on the relative benefits and harms of intervention. Patient reported outcome (PRO) data from clinical trials can " empower patients to make decisions based on their values" and " level the playing field between physician and patient" While clinicians have a good understanding of the concept of health-related quality of life and other PROs, evidence suggests that many do not feel comfortable in using the data from trials to inform discussions with patients and clinical practice. This may in part reflect concerns over the integrity of the data and difficulties in interpreting the results arising from poor reporting.The new CONSORT PRO extension aims to improve the reporting of PROs in trials to facilitate the use of results to inform clinical practice and health policy. While the CONSORT PRO extension is an important first step in the process, we need broader engagement with the guidance to facilitate optimal reporting and maximize use of PRO data in a clinical setting. Endorsement by journal editors, authors and peer reviewers are crucial steps. Improved design, implementation and transparent reporting of PROs in clinical trials are necessary to provide high quality evidence to inform evidence synthesis and clinical practice guidelines. © 2013 Calvert et al.; licensee BioMed Central Ltd. Source


Efficace F.,Health Outcomes Research Unit | Taphoorn M.,VU University Amsterdam | Taphoorn M.,Medical Center Haaglanden
Journal of Neuro-Oncology | Year: 2012

Health-related quality of life (HRQOL) and other types of patient-reported outcomes (PROs) are nowimportant outcome measures in cancer clinical trials. A number of potentially less toxic drugs are available, and newer treatments can potentially offer cancer patients the possibility to be treated with less aggressive approaches, making PROs more critical in evaluating treatment effectiveness. However, assessing PROs in clinical trials requires careful consideration of a number of methodological issues. Robust methodology and accurate reporting of results are crucial to provide the scientific community and health care providers with a transparent message about the impact of a given drug or a new medical approach on patients' health status. This paper provides basic guidance onmethodological issues to be addressed when designing and reporting HRQOL in clinical trials and presents examples of relevant brain cancer studies. © Springer Science+Business Media, LLC. 2012. Source


Bredart A.,University Pierre and Marie Curie | Bredart A.,University of Paris Descartes | Kop J.-L.,University of Lorraine | Efficace F.,Health Outcomes Research Unit | And 6 more authors.
Psycho-Oncology | Year: 2015

Background Cancer care is increasingly provided in the outpatient setting, requiring specific monitoring of care quality. The patients' perspective is an important indicator of care quality and needs to be assessed with well designed, psychometrically sound questionnaires. We performed a systematic literature review of currently available patient satisfaction measures for use in cancer outpatient care settings. Methods We carried out MEDLINE/PubMed, PsycINFO, CINAHL, and Scopus searches of papers published over the past 15 years that describe cancer patient satisfaction questionnaires for use in the outpatient setting. We used the adapted COSMIN checklist to assess the quality of the questionnaires' measurement properties. Results A total of 6677 citations were identified and 76 relevant articles were read, of which 55 were found either not to be relevant or to provide insufficient psychometric information. The remaining 21 studies pertained to 14 patient satisfaction questionnaires. Continuity and transition, accessibility, and involvement of family/friends were less frequently addressed despite their relevance in outpatient oncology. Almost half of the psychometric studies did not provide information on item level missing data. Most internal consistency estimates (Cronbach's α) were satisfactory. Few studies reported test-retest assessment (n = 5), used confirmatory factor analysis (n = 2), or assessed fit to a graded response item response theory model (n = 3). Only three questionnaires were cross-culturally validated. Conclusion Important aspects of care may be missed by current patient satisfaction questionnaires for use in the cancer outpatient setting. Additional evidence is needed of their psychometric performance, especially for cross-cultural comparative assessments. © 2014 John Wiley & Sons, Ltd. Source


Efficace F.,Health Outcomes Research Unit | Breccia M.,University of Rome La Sapienza | Saussele S.,University of Heidelberg | Kossak-Roth U.,University of Heidelberg | And 10 more authors.
Annals of Hematology | Year: 2012

The objective of this study was to investigate the health-related quality of life (HRQOL) aspects valued the most by patients with chronic myeloid leukemia (CML) receiving targeted therapies (TT), and to compare their perception with that of health-care professionals' (HCPs). Semi-structured interviews were conducted with 137 CML patients receiving TT from five different countries. An additional sample of 99 CML patients, completing an online interview, was considered for supportive analyses. A sample of 59 HCPs from 12 countries also participated in the study. Patients and HCPs were asked to rate and rank the importance of a predefined list of 74 HRQOL aspects of potential relevance for CML patients. Patients and HCPs agreed that the following five aspects are most important: fatigue, muscle cramps, swelling, worries, and uncertainty about health condition in the future, and importance of social support in coping with the disease. However, the difference in rankings between the two groups was substantial with respect to other HRQOL aspects investigated. Patients valued some issues related to symptoms much higher than HCPs, thus suggesting that a better symptom management could be the crucial aspects to improve HRQOL of CML patients.© 2012 Springer-Verlag. Source


Efficace F.,Health Outcomes Research Unit | Baccarani M.,University of Bologna | Breccia M.,University of Rome La Sapienza | Alimena G.,University of Rome La Sapienza | And 21 more authors.
Blood | Year: 2011

The main objective of this study was to investigate whether patients with chronic myeloid leukemia (CML) in treatment with long-term therapy imatinib have a different health-related quality-of-life (HRQOL) profile compared with the general population. In total, 448 CML patients were enrolled, and the SF-36 Health Survey was used to compare generic HRQOL profiles. Symptoms were also assessed. HRQOL comparisons were adjusted for key possible confounders. The median age of patients was 57 years and the median time of imatinib treatment was 5 years (range 3-9 years). The largest HRQOL differences were found in younger patients. In particular, patients aged between 18 and 39 years had marked impairments in role limitations because of physical and emotional problems, respectively: -22.6 (P < .001), -22.3 (P < .001). Patients with CML age 60 or older had a HRQOL profile very similar to that reported by the general population. Women had a worse profile than men when each were compared with their peers in the general population. Fatigue was the most frequently reported symptom. The HRQOL of CML patients is comparable with that of population norms in many areas, however, younger and female patients seem to report the major limitations. © 2011 by The American Society of Hematology. Source

Discover hidden collaborations