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Gutman SI, Oliansky DM, Belinson S, et al. PCA3 Testing in the Diagnosis and Management of Prostate Cancer: Future Research Needs: Identification of Future Research Needs From Comparative Effectiveness Review No. 98 [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Apr. (Future Research Needs Papers, No. 24.)
PCA3 Testing in the Diagnosis and Management of Prostate Cancer: Future Research Needs: Identification of Future Research Needs From Comparative Effectiveness Review No. 98 [Internet].
Show detailsFigure 3 outlines the steps of the process, briefly summarized here, which was used to conduct the PCA3 future research needs project. First, evidence gaps identified from the draft CER on PCA3 Testing in the Diagnosis and Management of Prostate Cancer were used to develop future research needs and preliminary questions. After the draft CER was completed, the literature search was updated and ClinicalTrials.gov was searched to identify any ongoing research studies that might address the research needs. Next, an eight-member Stakeholder Panel was convened, comprised of individuals with expertise and experience relevant to the topic under review. Stakeholders were charged with prioritizing research needs and generating and prioritizing research questions. Research needs and research questions were prioritized online using the SurveyMonkey® Web site. Finally, the exploration of the appropriateness of various study designs to address the research questions was conducted by the EPC. Details of these steps follow.
Figure 3
Process flow diagram for PCA3 FRN project. Abbreviations: EHC = effective health care; EPC = Evidence-based Practice Center
Identification and Prioritization of Research Needs
Project Scope
The PCA3 CER project team collaboratively identified evidence gaps for the draft CER. Two types of research needs were identified from these gaps: one set that focused on clinical issues specific to PCA3 testing and a second set that focused on statistical and methodological issues and were broadly relevant to the study of new biomarkers. The PCA3 Future Research Needs (FRN) team, with input from the AHRQ Task Order Officer, made the decision to focus on the issues of direct clinical importance in understanding the use of PCA3 testing. These included issues related to the clinical validity (diagnostic accuracy) of the test, as well as to its clinical utility (use in decisionmaking and impact on intermediate and long-term health outcomes). For informational purposes, the statistical and methodological issues identified in the draft PCA3 CER are presented in Appendix B.
Literature Search Update
To identify any recent, important published and ongoing studies potentially addressing the PCA3 research needs, a literature search was conducted on May 15, 2012, using MEDLINE® (via PubMed®), Embase.com, the Cochrane Library, and the ClinicalTrials.gov databases, as well as the American Society of Clinical Oncology conference abstracts. The search strategy captured studies published since August 1, 2011, and is provided in Appendix C.
Criteria for Prioritization
In developing criteria for prioritization, the Effective Health Care (EHC) Program Selection Criteria9 were modified to be applicable to primary research, rather than to systematic reviews of original research. They keep the spirit of the EHC criteria, but are more succinct. Table 1 provides a list of the prioritization criteria, which were used by the Stakeholder Panel when prioritizing the research needs and research questions relevant to this project.
Table 1
Prioritization criteria for PCA3 research needs and proposed research studies.
Engagement of Stakeholders, Researchers, Funders
Central to the methodology of this report was the use of a multidisciplinary Stakeholder Panel to identity and prioritize research needs and research questions. The Panel included individuals interested in comparative effectiveness research and who were knowledgeable about current research on PCA3. They consisted of eight participants (including two Federal representatives) representing diverse perspectives, including methodological/research expertise, clinical experience (urology, oncology, epidemiology), clinical laboratory experience, and patient and payer representation. The Stakeholder Panel included individuals with specific experience on the identification and treatment of prostate cancer. As proscribed by AHRQ, conflict of interest forms were completed by all members of the Stakeholder Panel and staff on this project.
The Stakeholders participated in a brief (i.e., 30-minute) orientation call with the team leader, who framed the topic and requested preliminary suggestions on further research needs. In addition, Stakeholders participated in two teleconference calls (1 hour each) over the course of the project, during which they provided input, first on the research needs and then the research questions. Alternative calls were scheduled as necessary with members who were unable to participate during the panel calls. All teleconference call materials were distributed a few days prior to scheduled calls. Interim communications were carried out by email.
The main role of the Stakeholder Panel was to refine and then prioritize, using an online survey, the list of research needs generated from the CER and from feedback obtained in the orientation calls. The Stakeholders also helped to refine, and then prioritized, a list of potential research questions to address the highest priority research needs.
Methods for Ranking Research Needs and Questions
Research needs were ranked via the SurveyMonkey® Web site. The Stakeholder Panel was sent a link to the Web site where they ranked the research needs from 3, for a ranking of first, to 1, for a ranking of third. The research need with the largest number of points was assigned the highest priority. Stakeholders also had the opportunity to provide comments about the survey. The same process was used by Stakeholders to prioritize the research questions associated with each research need.
Research Question Development and Study Design Considerations
Research questions for each research need were generated based on the original CER and input from Stakeholders during the orientation call, the two followup teleconferences, and by on-line solicitation. The project team compiled a final list of research questions for the three highest priority research needs; these were then prioritized by the Stakeholders according to importance.
The research needs and research questions were characterized according to the PICOTS framework using patient population (P), intervention (I), comparison (C), outcomes (O), timing (T), and setting (S). This approach is consistent with the guidance produced by the John Hopkins University EPC on behalf of AHRQ.10
Study design considerations were handled by the EPC in accordance with the recent Future Research Needs methods report authored by the RTI-UNC EPC on behalf of AHRQ.11 The following criteria were used to evaluate the appropriateness of any one study design to address a research need:
- Advantages of the study design for producing a valid result;
- Resource use, size, and duration;
- Ethical, legal, and social issues;
- Availability of data or ability to recruit
The PCA3 FRN team relied on this framework as a guide during discussions of the least biased study design that was likely to be feasible and affordable for each research question. The Stakeholder Panel provided insight into how future research agendas and proposed studies to address research needs fit within these prespecified criteria.
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