Development of National Research and Clinical Agendas for Patient-Reported Outcomes in IR: Proceedings from a Multidisciplinary Consensus Panel

Abstract

Patient-reported outcomes (PROs) are any report coming directly from patients about how they function or feel in relation to a health condition and its therapy without interpretation by physicians or others (1Food and Drug AdministrationGuidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.US Department of Health and Human Services. 2009; Google Scholar). Over the past 50 years, interventional radiology (IR) has pioneered minimally invasive, image-guided approaches that, in theory, lead to faster recovery and a better patient experience (2Charalel R.A. McGinty G. Brant-Zawadzki M. et al.Interventional radiology delivers high-value health care and is an Imaging 3.0 vanguard.J Am Coll Radiol. 2015; 12: 501-506Abstract Full Text Full Text PDF PubMed Scopus (23) Google Scholar). However, the evidence base to support these benefits has not yet been firmly established. The routine assessment of PROs could provide the needed evidence and guide shared decision making. Further, interventional radiologists are commonly involved in the care of patient populations for whom quality of life (QoL) may be more germane than clinician-reported outcomes. Examples include patients with chronic pain (3Turk D.C. Dworkin R.H. Allen R.R. et al.Core outcome domains for chronic pain clinical trials: IMMPACT recommendations.Pain. 2003; 106: 337-345Abstract Full Text Full Text PDF PubMed Scopus (948) Google Scholar), patients with cancer receiving rescue (also known as salvage) therapy, and patients in the end stages of disease seeking symptom palliation (4Kavalieratos D. Corbelli J. Zhang D. et al.Association between palliative care and patient and caregiver outcomes: a systematic review and meta-analysis.JAMA. 2016; 316: 2104Crossref PubMed Scopus (576) Google Scholar). Additionally, recent health care legislation emphasizes quality or value over quantity or volume of care, with financial incentives directly tied to higher care quality. In IR, tremendous opportunities exist to demonstrate quality using standardized instruments, also referred to as patient-related outcome measures (PROMs). Incorporating PROs into IR research and clinical practice may be challenging. For example, there are relatively few PROMs for disease states relevant to IR (5Meissner M.H. Gibson K. Clinical outcome after treatment of pelvic congestion syndrome: sense and nonsense.Phlebology. 2015; 30: 73-80Crossref PubMed Scopus (35) Google Scholar). Established PROMs for use in other contexts may not be optimal for use in IR-specific settings. Mounting demands on providers’ time must also be considered when integrating PRO into clinical practices. Not only must we seek to minimize administrative burden to practices, but there is also a risk of oversaturating patients with questionnaire requests. PRO collection may also be overly onerous for sick patients toward the end of life. Last, but not least, the heterogeneity of national IR practices and wide scope of individual practices (6Sunshine J.H. Lewis R.S. Bhargavan M. A portrait of interventional radiologists in the United States.AJR Am J Roentgenol. 2005; 185: 1103-1112Crossref PubMed Scopus (52) Google Scholar) preclude a one-size-fits-all approach; any strategy to incorporate PROs into IR will likely require a deliberate, systematic approach that initially targets high-yield populations and practice settings. In recognition of the strategic importance of and potential challenges to incorporating PROs into research and clinical practice, the Society of Interventional Radiology (SIR) Foundation convened a research consensus panel (RCP) to develop a cohesive strategy for the use of PROs in IR. On April 10, 2017, the SIR Foundation sponsored a panel of experts to meet and develop a national research and clinical agenda on PROs in IR. Panel members were selected from thought leaders and stakeholder representatives in the field of PROs by the RCP lead (S.W.K.) in consultation with SIR Foundation leadership. The 13-member panel was composed of 5 interventional radiologists, 3 PRO-research scientists, 2 surgeons, 1 medical oncologist, 1 representative from a patient advocacy group, and 1 representative from the Patient-Centered Outcomes Research Institute (PCORI). Provider, patient, and industry stakeholders were also invited to attend and participate in the meeting as audience members. Before the RCP meeting, participants were provided an agenda describing the meeting structure and intent of the meeting. The structure of the meeting differed slightly from previous SIR Foundation–sponsored RCPs, as the objective of this meeting was 2-fold: to identify and select priorities to advance the use of PROs in IR (i) for research and (ii) for clinical practice. The first half of the meeting was designed to improve understanding of PROs relevant to IR and to review the current status of PROs in IR and other medical specialties. Panelists gave 10-minute presentations related to their area of expertise as specified in discussions with the RCP lead before the meeting. Session topics included Background and Stakeholder Perspectives, Methodology, and Infrastructure and Implementation. Each session ended with question and answer opportunities for panel and audience members. The second half of the meeting consisted of round-table discussions with panel and audience members. To meet the bipartite objectives, discussions were focused around 4 subgoals (Table 1), which were sequenced so that the later subgoals were contingent on answers from the preceding subgoals. For each subgoal, panelists had an opportunity to suggest priorities during a brainstorming session. After consolidating similar ideas for priorities, panelists discussed the relative merits of each and degree of responsiveness to the RCP subgoals. Finally, panelists participated in open voting for specific priorities on the consolidated list, and the votes were tallied.Table 1Four Subgoals of the Research Consensus Panel1. Define objectives. What should be the goals of PRO-related research in IR? What should be the goals of collecting PROs in clinical IR practice?2. Identify target populations. What are the populations in which PRO data collection will yield the greatest return on investment?3. Determine requisite PROM characteristics. Acknowledging that there does not exist 1 perfect instrument for all purposes, what are the base requirements for PROM use in IR? What tradeoffs can be tolerated when choosing among imperfect PROMs?4. Identify specific avenues for advancing PROM use in IR. What are the next steps forward for IR to incorporate PROMs into research and clinical practice?PRO = patient-reported outcome; PROM = patient-related outcome measure. Open table in a new tab PRO = patient-reported outcome; PROM = patient-related outcome measure. The panelist presentations are summarized below. Substantial PRO research in IR-related therapies has focused on understanding changes to QoL following uterine fibroid embolization (UFE) (7Spies J.B. Warren E.H. Mathias S.D. Walsh S.M. Roth A.R. Pentecost M.J. Uterine fibroid embolization: measurement of health-related quality of life before and after therapy.J Vasc Interv Radiol. 1999; 10: 1293-1303Abstract Full Text PDF PubMed Scopus (90) Google Scholar, 8Spies J.B. Coyne K. Guaou Guaou N. Boyle D. Skyrnarz-Murphy K. Gonzalves S.M. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata.Obstet Gynecol. 2002; 99: 290-300Crossref PubMed Scopus (490) Google Scholar, 9Spies J.B. Myers E.R. Worthington-Kirsch R. et al.The FIBROID Registry: symptom and quality-of-life status 1 year after therapy.Obstet Gynecol. 2005; 106: 1309-1318Crossref PubMed Scopus (164) Google Scholar, 10Goodwin S.C. Spies J.B. Worthington-Kirsch R. et al.Uterine artery embolization for treatment of leiomyomata: long-term outcomes from the FIBROID Registry.Obstet Gynecol. 2008; 111: 22-33Crossref PubMed Scopus (196) Google Scholar), superficial and deep venous disease (11Kundu S. Lurie F. Millward S.F. et al.Recommended reporting standards for endovenous ablation for the treatment of venous insufficiency: joint statement of The American Venous Forum and The Society of Interventional Radiology.J Vasc Surg. 2007; 46: 582-589Abstract Full Text Full Text PDF PubMed Scopus (74) Google Scholar, 12Lamping D.L. Schroter S. Kurz X. Kahn S.R. Abenhaim L. Evaluation of outcomes in chronic venous disorders of the leg: development of a scientifically rigorous, patient-reported measure of symptoms and quality of life.J Vasc Surg. 2003; 37: 410-419Abstract Full Text PDF PubMed Scopus (260) Google Scholar, 13Kahn S.R. Lamping D.L. Ducruet T. et al.VEINES-QOL/Sym questionnaire was a reliable and valid disease-specific quality of life measure for deep venous thrombosis.J Clin Epidemiol. 2006; 59: 1049-1056Abstract Full Text Full Text PDF PubMed Scopus (119) Google Scholar, 14Vedantham S. Goldhaber S.Z. Kahn S.R. et al.Rationale and design of the ATTRACT Study: a multicenter randomized trial to evaluate pharmacomechanical catheter-directed thrombolysis for the prevention of postthrombotic syndrome in patients with proximal deep vein thrombosis.Am Heart J. 2013; 165: 523-530.e3Abstract Full Text Full Text PDF PubMed Scopus (151) Google Scholar), and catheter-directed treatment and locoregional therapy for hepatocellular carcinoma (15Wible B.C. Rilling W.S. Drescher P. et al.Longitudinal quality of life assessment of patients with hepatocellular carcinoma after primary transarterial chemoembolization.J Vasc Interv Radiol. 2010; 21: 1024-1030Abstract Full Text Full Text PDF PubMed Scopus (37) Google Scholar, 16Shun S.C. Chen C.H. Sheu J.C. Liang J.D. Yang J.C. Lai Y.H. Quality of life and its associated factors in patients with hepatocellular carcinoma receiving one course of transarterial chemoembolization treatment: a longitudinal study.Oncologist. 2012; 17: 732-739Crossref PubMed Scopus (35) Google Scholar, 17Toro A. Pulvirenti E. Palermo F. Di Carlo I. Health-related quality of life in patients with hepatocellular carcinoma after hepatic resection, transcatheter arterial chemoembolization, radiofrequency ablation or no treatment.Surg Oncol. 2012; 21: e23-e30Abstract Full Text Full Text PDF PubMed Scopus (54) Google Scholar, 18Salem R. Gilbertsen M. Butt Z. et al.Increased quality of life among hepatocellular carcinoma patients treated with radioembolization, compared with chemoembolization.Clin Gastroenterol Hepatol. 2013; 11: 1358-1365.e1Abstract Full Text Full Text PDF PubMed Scopus (164) Google Scholar) (also R. Salem, MD, et al, unpublished data, April 2017). PRO research in the arena of UFE has transformed practice patterns and treatment options for patients with uterine fibroids. A methodical research program first demonstrated health-related quality of life (HR-QoL) improvement following UFE in a single-center study (7Spies J.B. Warren E.H. Mathias S.D. Walsh S.M. Roth A.R. Pentecost M.J. Uterine fibroid embolization: measurement of health-related quality of life before and after therapy.J Vasc Interv Radiol. 1999; 10: 1293-1303Abstract Full Text PDF PubMed Scopus (90) Google Scholar), then created and validated a new PROM, the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire (8Spies J.B. Coyne K. Guaou Guaou N. Boyle D. Skyrnarz-Murphy K. Gonzalves S.M. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata.Obstet Gynecol. 2002; 99: 290-300Crossref PubMed Scopus (490) Google Scholar), and finally established a prospective registry (Fibroid Registry for Outcomes Data). The registry ultimately helped demonstrate significant improvement in mean symptom and HR-QoL scores by 1 year after UFE in a diverse patient and provider population (9Spies J.B. Myers E.R. Worthington-Kirsch R. et al.The FIBROID Registry: symptom and quality-of-life status 1 year after therapy.Obstet Gynecol. 2005; 106: 1309-1318Crossref PubMed Scopus (164) Google Scholar, 10Goodwin S.C. Spies J.B. Worthington-Kirsch R. et al.Uterine artery embolization for treatment of leiomyomata: long-term outcomes from the FIBROID Registry.Obstet Gynecol. 2008; 111: 22-33Crossref PubMed Scopus (196) Google Scholar). Together, these results demonstrate how a well–thought out, PRO-centered research agenda can support the widespread acceptance of a new, minimally invasive treatment. In the treatment of venous insufficiency, several questionnaires have been developed to assess disease and symptom severity, including the Venous Insufficiency Epidemiologic and Economic Study of Quality of Life (VEINES-QOL/Sym), Chronic Venous Insufficiency Questionnaire-2 (CIVIQ-2), and Aberdeen questionnaires (11Kundu S. Lurie F. Millward S.F. et al.Recommended reporting standards for endovenous ablation for the treatment of venous insufficiency: joint statement of The American Venous Forum and The Society of Interventional Radiology.J Vasc Surg. 2007; 46: 582-589Abstract Full Text Full Text PDF PubMed Scopus (74) Google Scholar). Recently, the landmark ATTRACT trial investigated PROs as a secondary outcome measure for patients with deep venous thrombosis who were randomly assigned to pharmacomechanical catheter-directed thrombolysis versus no pharmacomechanical catheter-directed thrombolysis and found no statistically significant QoL differences at 24 months between the groups (14Vedantham S. Goldhaber S.Z. Kahn S.R. et al.Rationale and design of the ATTRACT Study: a multicenter randomized trial to evaluate pharmacomechanical catheter-directed thrombolysis for the prevention of postthrombotic syndrome in patients with proximal deep vein thrombosis.Am Heart J. 2013; 165: 523-530.e3Abstract Full Text Full Text PDF PubMed Scopus (151) Google Scholar). Although there has been a large body of QoL-focused work on general oncology treatments, disease-specific QoL research following interventional oncology treatments remains limited. HR-QoL has been evaluated using generic QoL instruments following transarterial chemoembolization for hepatocellular carcinoma (15Wible B.C. Rilling W.S. Drescher P. et al.Longitudinal quality of life assessment of patients with hepatocellular carcinoma after primary transarterial chemoembolization.J Vasc Interv Radiol. 2010; 21: 1024-1030Abstract Full Text Full Text PDF PubMed Scopus (37) Google Scholar, 16Shun S.C. Chen C.H. Sheu J.C. Liang J.D. Yang J.C. Lai Y.H. Quality of life and its associated factors in patients with hepatocellular carcinoma receiving one course of transarterial chemoembolization treatment: a longitudinal study.Oncologist. 2012; 17: 732-739Crossref PubMed Scopus (35) Google Scholar), and smaller case series have compared transarterial chemoembolization with other alternative therapies using a disease-specific questionnaire, the FACT-Hep (17Toro A. Pulvirenti E. Palermo F. Di Carlo I. Health-related quality of life in patients with hepatocellular carcinoma after hepatic resection, transcatheter arterial chemoembolization, radiofrequency ablation or no treatment.Surg Oncol. 2012; 21: e23-e30Abstract Full Text Full Text PDF PubMed Scopus (54) Google Scholar). When comparing transarterial chemoembolization with radioembolization, no overall difference in FACT-Hep scores was seen at 2 or 4 weeks; however, social well-being and functional well-being scores were significantly higher in the radioembolization group (18Salem R. Gilbertsen M. Butt Z. et al.Increased quality of life among hepatocellular carcinoma patients treated with radioembolization, compared with chemoembolization.Clin Gastroenterol Hepatol. 2013; 11: 1358-1365.e1Abstract Full Text Full Text PDF PubMed Scopus (164) Google Scholar), suggesting better patient-centered outcomes in this group. These early experiences have shed light on the potential for varying results depending on PROM instrument choice and the nuanced differences between therapies. This is an area ripe for further research. Additional PRO research has been performed in other areas relevant to IR clinical practices, including hemodialysis (19Feroze U. Noori N. Kovesdy C.P. et al.Quality of life and mortality in hemodialysis patients: roles of race and nutritional status.Clin J Am Soc Nephrol. 2011; 6: 1100-1111Crossref PubMed Scopus (93) Google Scholar), stroke (20King R.B. Quality of life after stroke.Stroke. 1996; 27: 1467-1472Crossref PubMed Scopus (417) Google Scholar), and central venous access (21Bow E.J. Kilpatrick M.G. Clinch J.J. Totally implantable venous access ports systems for patients receiving chemotherapy for solid tissue malignancies: a randomized controlled clinical trial examining the safety, efficacy, costs, and impact on quality of life.J Clin Oncol. 1999; 17: 1267Crossref PubMed Google Scholar). Despite strides in certain disease domains, overall PRO integration and reporting remains limited in IR-based therapies compared with other medical and surgical alternatives. Patients and caregivers seek high-quality, person-centered care that provides (i) understandable information about treatment choices, tradeoffs, and functional and QoL implications; (ii) skilled clinical communication that engages patients and caregivers as partners in identifying goals, weighing options, and making decisions based on what’s important to them; and (iii) person-centered and coordinated care delivery that is accountable throughout the care continuum for honoring people’s priorities and preferences (22Institute of Medicine (US) Committee on Quality of Health Care in AmericaCrossing the Quality Chasm: A New Health System for the 21st Century. National Academies Press, Washington, D.C.2001Google Scholar, 23Institute of MedicineBest Care at Lower Cost: The Path to Continuously Learning Healthcare in America. National Academies Press, Washington, D.C.2012Google Scholar). Issues of concern during the course of receiving medical care may include functional status changes, role change, symptoms, stress of illness on family, loss of control, financial burden, stigma of illness, and conflict between wanting to know and a fear of knowing. To improve care, the outcomes measured should reflect the health circumstances most relevant to patients, and PRO data must be routinely monitored (eg, in a rapid learning cycle). PROs should also be shared among clinicians, patients, and families to enhance shared decision making. Truly person-centric care can result in a positive experience even when the ultimate medical outcome is poor (24Kotronoulas G. Kearney N. Maguire R. et al.What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials.J Clin Oncol. 2014; 32: 1480-1501Crossref PubMed Scopus (504) Google Scholar, 25Valderas J.M. Kotzeva A. Espallargues M. et al.The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature.Qual Life Res. 2008; 17: 179-193Crossref PubMed Scopus (514) Google Scholar). Researchers find value in PROs because, as a direct estimate of treatment effect on patient symptoms, functional status, and QoL, they provide outcome data that are not obtainable in other ways. PROs can allow for direct comparison of outcomes for disparate therapies. PROs are particularly important in situations where objective and surrogate measures of outcome are inadequate. These data are increasingly vital in an era where patients have an enhanced role in directing care as well as provide a basis for cost-effectiveness and cost-utility studies. For research purposes, disease-specific PROMs are often considered more useful owing to theoretically greater sensitivity to changes, although exceptions exist. An ideal PROM selected for a research protocol should be reliable, validated in the intended disease population, applicable to a range of therapeutic options for the disease in question, valid for both cross-sectional and longitudinal use, have an established minimally important clinical difference, and be short and easily administered (26Basch E. Spertus J. Dudley R.A. et al.Methods for developing Patient-Reported Outcome-Based Performance Measures (PRO-PMs).Value Health. 2015; 18: 493-504Abstract Full Text Full Text PDF PubMed Scopus (78) Google Scholar). Additional positive attributes include recognition by the US Food and Drug Administration as a valid primary outcome measure and demonstrated validity in the intended population when administered electronically. When an appropriate PROM meeting most of these criteria is not available, creation of a new instrument can be considered, but the process is time-consuming, is expensive, and may require collaboration with experienced psychometricians. As the major funder of patient-centered research in the United States, PCORI aims to support research that examines health care decision making, with an eye to learning more about potential benefits and harms from patient and caregiver perspectives. Selecting and integrating PROs represents an important hallmark of the commitment of PCORI to “research done differently.” PCORI investments that focus on and/or have sought to integrate PROs fall into 3 categories: comparative effectiveness research clinical studies, methodologic research, and research infrastructure. Successful grant submission for clinical studies should include PROs that reflect what is important to patients, provide rigorous proposals for the collection and analysis of PRO data, and ultimately generate PRO-related evidence that is both meaningful to patients and clinically actionable. Methodologic proposals should foster improvements in the analysis and interpretability of PRO data as well as innovations in routine implementation and collection of PROs. Research infrastructure investments, the prime example being the PCORnet, have led to incorporation of PROMs in the common data set recommendations for participating networks (27The National Patient-Centered Clinical Research NetworkPCORnet Common Data Model (CDM).http://www.pcornet.org/pcornet-common-data-model/Google Scholar). National organizations are moving toward recommending PRO-based performance metrics in addition to conventional metrics. The National Quality Forum makes a useful distinction between PROs, PROMs, and patient-reported outcome–based performance measures (PRO-PMs). PRO-PMs are quality-of-care metrics based on PROM data aggregated for an accountable health care entity and compared across systems (28Stover A.M. Care delivery case study: implementing patient-reported outcomes (PROs) measures into routine cancer care delivery.in: Chambers D.A. Norton W.E. Optimizing the Cancer Control Continuum: Advancing Implementation Research. Oxford University Press, New York, NY2018Google Scholar). For instance, the National Quality Forum depression PRO-PM (#0711) records the percentage of patients with major depressive disorder who initially present with a Patient Health Questionnaire-9 score > 9 (28Stover A.M. Care delivery case study: implementing patient-reported outcomes (PROs) measures into routine cancer care delivery.in: Chambers D.A. Norton W.E. Optimizing the Cancer Control Continuum: Advancing Implementation Research. Oxford University Press, New York, NY2018Google Scholar). High-quality care is defined as depression remission at 6 months (follow-up score of < 5) (29National Quality Forum. Patient-reported outcomes-based performance metrics. 2013. Available at: https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=72537. Accessed October 30, 2017.Google Scholar). In a PCORI-funded study, Stover (28Stover A.M. Care delivery case study: implementing patient-reported outcomes (PROs) measures into routine cancer care delivery.in: Chambers D.A. Norton W.E. Optimizing the Cancer Control Continuum: Advancing Implementation Research. Oxford University Press, New York, NY2018Google Scholar) interviewed clinicians, health care decision makers, and health services researchers about their perceptions of using PRO-PMs to evaluate the quality of care delivered during chemotherapy. Perceptions of using PRO-PMs to evaluate chemotherapy care were varied: there was trepidation about the unknown consequences of PRO-PM results within a health care system and with payers, but there were also positive ideas about quality improvement initiatives that could be undertaken in a health care system if PROM scores were available. Stakeholders were also asked about barriers to implementing PROs into routine care (29National Quality Forum. Patient-reported outcomes-based performance metrics. 2013. Available at: https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=72537. Accessed October 30, 2017.Google Scholar, 30Stover A.M. Basch E.M. Implementing symptom questionnaires into oncology workflow.J Oncol Pract. 2016; 12: 859-962Crossref PubMed Scopus (11) Google Scholar). A dominant theme was that PRO-PMs should be clinically useful, intuitive, and reported back to clinicians and patients frequently (ideally through the electronic health record [EHR]). Stakeholders suggested using PROM scores both for patient care and as quality metrics. The most frequently reported barriers to PROM implementation were structural and related to workflow, rather than acceptability. Cancer stakeholders consistently reported that one of their largest barriers was the lack of health record system functionality to collect, store, and feed back PROM scores to clinicians in intuitive ways. Clinicians from several health care systems described “black holes”—where PROMs were collected on paper and scanned into the EHR, where they were difficult to retrieve and therefore rarely examined. Patients may be less likely to complete PROMs at future visits if they perceive that clinicians are not going to review or use their responses as part of their care. The development, modification, and validation of a PRO instrument usually occur in a nonlinear fashion with a varying sequence of events, simultaneous processes, or iterations. The Food and Drug Administration has published a Roadmap to Patient-Focused Outcome Measurement in Clinical Trials (31Food and Drug AdministrationRoadmap to Patient-Focused Outcome Measurement in Clinical Trials.https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/UCM370174.pdfGoogle Scholar). The Roadmap outlines each step in the process for understanding the effects of a treatment, taking into account the condition of interest and the desired outcomes from the patient perspective, and incorporating this knowledge into the selection, adaptation, or development of appropriate endpoints reflective of outcomes meaningful and important to patients. The Roadmap can be applied to determination of disease-specific, targeted, or generic outcome measures as potential PROs in IR trials. Additional recommendations for application to clinical practice have been described by other organizations and individual authors, including the International Society for Quality of Life Research (32Reeve B.B. Wyrwich K.W. Wu A.W. et al.ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research.Qual Life Res. 2013; 22: 1889-1905Crossref PubMed Scopus (496) Google Scholar) and PCORI (33Patient Centered Outcomes Research Institute. The design and selection of Patient Reported Outcomes Measures for Use in Patient Centered outcomes research. 2012. Available at: https://www.pcori.org/assets/The-Design-and-Selection-of-Patient-Reported-Outcomes-Measures-for-Use-in-Patient-Centered-Outcomes-Research1.pdf. Accessed July 27, 2017.Google Scholar). Before the selection of an existing measure, modification of an existing measure for a specific application, or developing a new measure, the researcher or practitioner needs to develop a comprehensive understanding of the underlying disease or condition and conceptualize treatment benefit, in particular, the concept of interest and the context of use. The actual PROM can then be based on well-established procedures for measure development that build on decades of experience in psychological assessment and health outcomes research. In the final application of a PROM in research or practice, an important challenge resides in interpreting the measure, and a considerable literature exists on approaches to PROM interpretation. In clinical trials, the Cochrane Collaboration has produced guidelines for interpretation (34Higgins JPT, Churchill R, Chandler J, Cumpston MS, eds. Cochrane Handbook for Systematic Reviews of Interventions Version 5.2.0 (updated February 2017), 2017. Available at: http://training.cochrane.org/handbook. Accessed November 30, 2017.Google Scholar). In clinical practice and in the application of PROMs to individuals, the above-referenced guides assist in thinking through approaches to interpretation primarily based on identifying an anchor for helping to evaluate the meaning of a new or less well-known measure. Many groups have put forth standards for the development and validation of PROMs, including the Patient-Reported Outcomes Measurement Information System (PROMIS) Group funded by the National Institutes of Health (35PROMIS Instrument Development and Validation Scientific Standards Version 2.0.http://www.healthmeasures.net/images/PROMIS/PROMISStandards_Vers2.0_Final.pdfGoogle Scholar, 36Reeve B. Hays R. Bjorner J. et al.Psychometric evaluation and calibration of a health-related quality of life items banks: plans for the Patient-Reported Outcomes Measurement Information Systems (PROMIS).Med Care. 2007; 45: S22-S31Crossref PubMed Scop