-
Michael Brundage,
Jane Blazeby,
Dennis Revicki, Brenda Bass,
Henrica de Vet,
Helen Duffy,
Fabio Efficace,
Madeleine King,
Cindy L K Lam,
David Moher,
Jane Scott,
Jeff Sloan,
Claire Snyder,
Susan Yount,
Melanie Calvert
[show abstract]
[hide abstract]
ABSTRACT: PURPOSE: To develop expert consensus on a suite of reporting standards for HRQL outcomes of RCTs. METHODS: A Task Force of The International Society of Quality of Life Research (ISOQOL) undertook a systematic review of the literature to identify candidate reporting standards for HRQL in RCTs. Subsequently, a web-based survey was circulated to the ISOQOL membership. Respondents were asked to rate candidate standards on a 4-point Likert scale based on their perceived value in reporting studies in which HRQL was a study outcome (primary or secondary). Results were synthesized into draft reporting guidelines, which were further reviewed by the membership to inform the final guidance. RESULTS: Forty-six existing candidate standards for reporting HRQL results in RCTs were synthesized to produce a 40 item survey that was completed electronically by 161 respondents. The majority of respondents rated all 40 items to be either 'essential' or 'desirable' when HRQL was a primary RCT outcome. Ratings changed when HRQL was a secondary study outcome. Feedback on the survey findings resulted in the Task Force generalizing the guidance to include patient-reported outcomes (PROs). The final guidance, which recommends standards for use in reporting PROs generally, and more specifically, for PROs identified as primary study outcomes, was approved by the ISOQOL Board of Directors. CONCLUSIONS: ISOQOL has developed a suite of recommended standards for reporting PRO results of RCTs. Improved reporting of PROs will enable accurate interpretation of evidence to inform patient choice, aid clinical decision making, and inform health policy.
Quality of Life Research 09/2012; · 2.30 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Study Type - Prognosis (systematic review) Level of Evidence 1a What's known on the subject? and What does the study add? Prognostic factors such as serum PSA, tumor T stage, and Gleason grading are commonly used to predict disease progression and mortality in prostate cancer and to guide treatment decision-making. These markers are combined to define risk strata that are commonly accepted in practice. Despite the assignment of patients to a specific risk stratum (e.g. intermediate-risk disease), however, within-stratum survival duration varies considerably, suggesting that many other factors, including lymphovascular invasion (LVI) may influence prognosis. LVI is currently a recognized prognostic factor in the management of some cancers (e.g. in early-stage breast cancer) and prostate cancer is known to spread via lymphatic channels. Furthermore, the reporting of microscopic lymphovascular invasion is now considered part of the standard pathologic report of prostatectomy specimens. Nevertheless, scientific studies in this area have produced conflicting conclusions regarding the utility of LVI as a prognostic indicator in prostate cancer. This paper provides a comprehensive review and synthesis of the recent literature. Although a number of studies examining the role of LVI as an independent prognostic factor for biochemical recurrence in prostate cancer have been reported, the characteristics, quality and results of these studies vary considerably. The value of using LVI as a prognostic factor in prostate cancer remains unclear. This study provides a systematically-performed synthesis of the results of recent research including lymphovascular invasion (LVI) in the multivariate analyses of potential prostate cancer prognostic factors. Not only do we report on the results of these studies, we assess the heterogeneity of the study populations, disease characteristics, and quality of the studies. Ultimately, we determined that meta-analysis of the existing data is not possible, and thus, there is no 'best estimate' of the strength of association between LVI status and disease recurrence after prostatectomy. Most studies, but not all, reveal a weak or statistically insignificant association between LVI status and recurrence. We therefore conclude with a recommendation to clinicians that they should not overweight the importance of LVI status on clinical prognostication. The use of LVI status as a strong predictor of clinical outcomes is not recommended. OBJECTIVES: • To synthesize the results of studies including lymphovascular invasion (LVI) in the multivariate analyses of potential prostate cancer prognostic factors. • To determine the role of LVI as an independent prognostic factor for biochemical recurrence in prostate cancer. PATIENTS AND METHODS: • We performed a comprehensive systematic literature review of studies examining the association between LVI in prostatectomy specimens and prostate cancer recurrence. • Ovid MEDLINE, Embase, Web of Knowledge, Cochrane Database of Systematic Reviews, Database of Abstracts of Review of Effects (DARE) and Google Scholar were searched from January 2000 to February 2009. • The primary outcome of interest was biochemical recurrence measured by serum prostate specific antigen (PSA). RESULTS: • One thousand two hundred and forty-eight papers met our search criteria. Of these, 19 articles meeting our selection criteria reported results of a multivariate analysis to evaluate LVI as an independent prognostic factor of biochemical recurrence. • Eleven (58%) of these studies concluded that LVI was an independent prognostic factor. • Significant heterogeneity in the study population, disease characteristics and quality of the studies prevented meta-analysis of the results. • In the nine studies in which the magnitude of independent association of LVI with recurrence was reported, it ranged from an odds ratio or relative risk of 1.37 to 4.39. CONCLUSIONS: • The existing literature is conflicting and of insufficient homogeneity to definitively establish LVI as an important independent prognostic factor of biochemical recurrence in prostate cancer prostatectomy specimens. • Additional adequately powered studies are required to determine the clinical value of reports of LVI involvement. • In the meantime, the use of LVI status as an independent prognostic factor for clinical prognostication and medical decision making is not recommended.
BJU International 04/2012; · 2.84 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: To develop a set of indicators of the quality of radiotherapy (RT) for localized prostate cancer.
Following a comprehensive review of the literature to identify candidate quality indicators, we utilized a modified Delphi technique to develop a set of indicators of the quality of RT for localized prostate cancer. The first Delphi round consisted of an online survey in which radiation oncologists were asked to rate the importance of the candidate quality indicators. The second round was a face-to-face meeting of a smaller group of radiation oncologists to discuss, rate, and rank a final set of quality indicators.
The literature review identified 57 candidate quality indicators. After the two rounds of the Delphi process, a final set of 25 indicators was agreed upon. The set includes quality indicators covering all aspects of prostate cancer radical RT management: pre-treatment assessment, external beam RT, brachytherapy, androgen deprivation therapy, and follow-up.
This new set of quality indicators is more comprehensive than others described in the literature, and can be applied to patterns of care studies that assess the quality of RT for prostate cancer. The process used to develop this set of indicators can be readily adapted for use in other contexts.
Radiotherapy and Oncology 03/2011; 99(1):29-36. · 5.58 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Measurement and reporting of health-related quality of life (HRQL) data have evolved considerably over the past 10 years. Our goal was to identify the current barriers to, and enablers of, the effective translation of HRQL outcome data from randomized clinical trials by investigating physician attitudes, knowledge, and education needs.
We undertook a mixed qualitative and quantitative study of 33 oncologists' attitudes and educational needs around the value, interpretation, and application of HRQL data from cancer clinical trials. The approach was designed to identify barriers and enablers relating to the characteristics of the knowledge itself, to the potential users of the knowledge, and to the environment in which the knowledge is used.
The majority of barriers and enablers identified were "second order", i.e., related to the understandability and generalizability of the data, its presentation, its accessibility within the medical literature, and its relevance to specific patient populations.
Our results suggest knowledge translation (KT) of HRQL results would improve if the clinical trial HRQL data were easily accessible to clinicians, and presented in a comprehensible and clinically applicable format, which includes discussion of the relevance of the measurement domains and implications of the findings. We recommend that standards of clinical trial HRQL reporting be implemented in clinical journals.
Quality of Life Research 01/2011; 20(7):979-85. · 2.30 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: To assess the patterns of, and trends over time in, health-related quality of life (HRQL) reporting in randomized controlled trials (RCTs).
The English-language literature of RCTs published in 2002-2008 was identified using Medline, Embase, and Healthstar databases, in addition to the Cochrane Clinical Trials Registry. Eligible trials were phase III studies that included an HRQL outcome. Data were abstracted on eight outcomes derived from previously recommended quality standards for reporting HRQL, and on four outcomes describing how HRQL data are presented in RCT reports. Two readers examined each article; discrepancies were resolved through discussion and third review if required.
A sample of 794 RCTs was identified. HRQL was a primary outcome in 25.4% (200/794). One hundred and ten RCTs (14%) used "supplementary" reports (separate from the first publication) to report HRQL findings. The proportion of RCTs that met the eight quality indicators ranged from 15% (HRQL used in the calculation of sample size) to 81% (reporting instrument validity). RCTs with HRQL as a primary outcome or with a supplementary report had higher concordance on the quality measures. Reporting improved on many indicators over time. Substantive variation in how HRQL data are presented in RCTs was evident.
Current practice of reporting HRQL outcomes in RCTs remains highly variable, both with regard to quality of reporting and the patterns of data analysis and presentation. This variation presents challenges for clinicians to apply these data in clinical practice. Consistent reporting practices, which are interpretable by clinicians, are required, as are processes to achieve this consistency in future reports.
Quality of Life Research 11/2010; 20(5):653-64. · 2.30 Impact Factor
