Development and Testing of a Chronic-Disease Patient Experience Mapping Toolbox.

BACKGROUND: Stakeholders increasingly expect research and care delivery to be guided by and to optimize patient experiences. However, standardized tools to engage patients to gather high-quality data about their experiences, priorities, and desired outcomes are not publicly available. The objective of this study was to develop and test a Toolbox with a disease-agnostic interview guide template and accompanying resources to assist researchers in engaging patients living with chronic disease in a dialogue about their experiences. METHODS: Guided by a multidisciplinary workgroup, a targeted literature review (PubMed) was conducted, followed by group discussions to identify/thematically organize patient experience concepts, development of a conceptual model, and drafting of an interview guide template and patient-facing visual. Materials were tested/refined via cognitive (n = 5) and pilot (n = 30) interviews conducted virtually with US patients diagnosed with chronic/potentially disabling conditions from December 2020 to April 2021. Patient-facing tools were reviewed by health literacy experts for applicability/accessibility. English-speaking adults who self-reported receiving a chronic condition diagnosis at least 6 months prior participated in a 60-90 min interview. RESULTS: Patient experience concepts were organized thematically under three domains: (1) life before a diagnosis, (2) experiences getting a diagnosis, and (3) experiences living with a diagnosis. A plain language consent sheet template, interview guide template, and patient experience conceptual model were developed and revised based on input from interviewees, interviewers, and the workgroup. CONCLUSIONS: A disease-agnostic patient-engagement Toolbox was developed and tested to capture patient experience data. These materials can be customized based on study objectives and leveraged by various stakeholders to identify opportunities to enhance the patient centricity of healthcare delivery and research.

Patient-centeredness and psychometric properties of the Defense and Veterans Pain Rating Scale 2.0 (DVPRS).

OBJECTIVE: This study aims to assess the patient-centeredness and psychometric properties of the Defense and Veterans Pain Rating Scale 2.0 (DVPRS) as a patient-reported outcome measure (PROM) for pain assessment in a military population. DESIGN: A critical evaluation of the DVPRS was conducted, considering its fit-for-purpose as a PROM and its patient-centeredness using the National Health Council's Rubric to Capture the Patient Voice. SETTING: The study focused on the use of the DVPRS within the Department of Defense (DoD) and Veterans Health Administration (VA) healthcare settings. SUBJECTS: The DVPRS was evaluated based on published studies and information provided by measure developers. The assessment included content validity, reliability, construct validity, and ability to detect change. Patient-centeredness and patient engagement were assessed across multiple domains. METHODS: Two independent reviewers assessed the DVPRS using a tool/checklist/questionnaire, and any rating discrepancies were resolved through consensus. The assessment included an evaluation of psychometric properties and patient-centeredness based on established criteria. RESULTS: The DVPRS lacked sufficient evidence of content validity, with no patient involvement in its development. Construct validity was not assessed adequately, and confirmatory factor analysis was not performed. Patient-centeredness and patient engagement were also limited, with only a few domains showing meaningful evidence of patient partnership. CONCLUSIONS: The DVPRS as a PROM for pain assessment in the military population falls short in terms of content validity, construct validity, and patient-centeredness. It requires further development and validation, including meaningful patient engagement, to meet current standards and best practices for PROMs.

Patient-Centered Core Impacts Sets (PC-CIS): What They Are and What They Are Not.

Letter to the Editor We are writing regarding the Innovations in Pharmacy commentary entitled, "Evidentiary Standards for Patient-Centered Core Impact Value Claims."(1) We thank Dr. Langley for commenting on the National Health Council's work on patient-centered core impact sets (PC-CIS), an initiative spearheaded by the nonprofit organization and its membership with multi-stakeholder representation and input.(2-4) While we have tried to be clear and transparent about the intent of PC-CIS, the commentary made it apparent to us we need to (and will) do more to be explicit about what a PC-CIS is and is not, and its possible downstream uses. We believe the PC-CIS concept was misrepresented in the commentary and want to provide clarification for readers so they can consider the merits of the initiative for themselves.

A Foundation for Patient-Centered Core Impact Sets: Key Learnings from Past and Existing Approaches.

Despite growing commitment to patient centricity, challenges persist in consistently identifying the impacts of disease and/or treatment that patients report as most important to them, especially across myriad potential downstream uses. Patient-centered core impact sets (PC-CIS), disease-specific lists of impacts that patients report as most important, are proposed as a solution. But, PC-CIS is a new concept, currently in the pilot stage with patient advocacy groups. We conducted an environmental scan to explore PC-CIS conceptual overlap with past/existing efforts [e.g., core outcome sets (COS)] and to inform general feasibility for further development and operationalization. With guidance and advice from an expert advisory committee, we conducted a search of the literature and relevant websites. Identified resources were reviewed for alignment with the PC-CIS definition, and key insights were gleaned. We identified 51 existing resources and five key insights: (1) no existing efforts identified meet the definition of PC-CIS as we have specified it in terms of patient centricity, (2) existing COS-development efforts are a valuable source of foundational resources for PC-CIS, (3) existing health-outcome taxonomies can be augmented with patient-prioritized impacts to create a comprehensive impact taxonomy, (4) current approaches/methods can inadvertently exclude patient priorities from core lists/sets and will need to be modified to protect the patient voice, and (5) there is need for clarity and transparency on how patients were engaged in individual past/existing efforts. PC-CIS is conceptually unique from past/existing efforts in its explicit emphasis on patient leadership and being patient driven. However, PC-CIS development can leverage many resources from the past/existing related work.

Developing Patient-Centered Real-World Evidence: Emerging Methods Recommendations From a Consensus Process.

OBJECTIVES: The Joint ISPOR-ISPE Special Task Force on Real-World Evidence included patient/stakeholder engagement as a recommended good procedural practice when designing, conducting, and disseminating real-world evidence (RWE). However, there are no guidelines describing how patient experience data (PED) can be applied when designing real-world data (RWD) studies. This article describes development of consensus recommendations to guide researchers in applying PED to develop patient-centered RWE. METHODS: A multidisciplinary advisory board, identified through recommendations of collaborators, was established to guide development of recommendations. Semistructured interviews were conducted to identify how experienced RWD researchers (n = 15) would apply PED when designing a hypothetical RWD study. Transcripts were analyzed and emerging themes developed into preliminary methods recommendations. An eDelphi survey (n = 26) was conducted to refine/develop consensus on the draft recommendations. RESULTS: We identified 13 recommendations for incorporating PED throughout the design, conduct, and translation of RWE. The recommendations encompass themes related to the development of a patient-centered research question, designing a study, disseminating RWE, and general considerations. For example, consider how patient input can inform population/subgroups, comparators, and study period. Researchers can leverage existing information describing PED and may be able to apply those insights to studies relying on traditional RWD sources and/or patient registries. CONCLUSIONS: Applying these emerging recommendations may improve the patient centricity of RWE through improved relevance of RWE to patient communities of interest and foster greater multidisciplinary participation and transparency in RWD research. As researchers gather experience by applying the methods recommendations, further refinement of these consensus recommendations may lead to "best practices."

Stakeholder perception of pharmaceutical value: A multicriteria decision analysis pilot case study for value assessment in the United States.

BACKGROUND: Recent attention to value frameworks has highlighted limitations of current conventional value and health technology assessment (V/HTA) methods (eg, cost-effectiveness). Multicriteria decision analysis (MCDA) has potential as a supplemental tool to incorporate additional value criteria into conventional value assessment. OBJECTIVE: To conduct a pilot study to illustrate the impact of an MCDA approach on the value perceptions of hypothetical treatment profiles from a multistakeholder panel. METHODS: Participants voted on value perceptions of 2 hypothetical treatments with similar cost-effectiveness evidence: Treatment A for aggressive B-cell non-Hodgkin lymphoma in adults and treatment B for episodic migraine in adults. Participants voted treatments A and B as low, intermediate, or high value before and after a weighting exercise on prespecified, additional value criteria. Weights from participants were used to calculate treatment-specific MCDA scores from 0 (least favorable) to 100 (most favorable) and were presented to participants for a second value-perception vote. Analyses compared changes in value perceptions within treatments A and B post-MCDA exercise. RESULTS: Before considering MCDA scores for treatment A, 0% of participants considered it to be low, 52% intermediate, and 48% high value. After considering MCDA scores for treatment A, 4% considered it low, 29% intermediate, and 67% high value. Both before and after considering MCDA scores for treatment B, 13%, considered it low, 57% intermediate, and 30% high value. Mean MCDA scores for treatments A and B were 67 and 63, respectively. Of all stakeholders, 41% altered their perception of value for treatment A (9% negatively and 32% positively) and, separately, 45% for treatment B (23% both negatively and positively) after considering MCDA scores. CONCLUSIONS: With nearly half of participants altering their perception of value after consideration of additional value criteria, findings support the need for a more inclusive and flexible value assessment process. DISCLOSURES: This study was funded by The National Pharmaceutical Council. Dr Perfetto was employed by the National Health Council (NHC) at the time this work was completed, and all honoraria and consulting and travel fees were paid to the NHC. The NHC is a not-for-profit, membership organization. It is supported through membership dues and sponsorship funds. The complete list of members and sponsors is located on the NHC's website at www.nationalhealthcouncil.org. She is also an advisor for the Brain Injury Association of America, Dan Lewis Foundation, and Canter for Medical Technology Policy.

Patient-Centered Core Impact Sets: What They are and Why We Need Them.

A quote attributed to Mark Twain states, "What gets us into trouble is not what we don't know. It's what we know for sure that just ain't so." The growing focus on patient centricity has revealed a misalignment between what patients report as important to them about their disease and/or treatment, and the data collected in research and care. Decisions across healthcare are made using an evidence base most stakeholders acknowledge is inadequate. Patients might report that what is important to them are everyday life impacts, concepts that can be very different from the more typical clinical outcomes we often track. In this paper, we encourage expanding current thinking to all "impacts," not only health outcomes, but also the other equally (and sometimes more important) concerns patients report as important to them. We propose that a patient-centered core impact set be developed for each disease or condition of interest, and/or subpopulation of patients. A patient-centered core impact set begins with gathering from patients and caregivers an inventory of all impacts disease and treatments have on a patient's (and carers' and families') life. Then, through a formal prioritization process, a core set of impacts is derived, inclusive of but extending beyond relevant health outcomes. We offer several recommendations on how to move the goal of a patient-centered core impact set forward through collaboration, leadership, and establishment of a patient-centered core impact set development blueprint with supporting tools.

Value-based evidence across health care sectors: a push for transparent real-world studies, data, and evidence dissemination.

There is currently a heightened need for transparency in pharmaceutical sectors. The inclusion of real-world (RW) evidence, in addition to clinical trial evidence, in decision-making processes, was an important step forward toward a more inclusive established value proposition. This advance has introduced new transparency challenges. Increasing transparency is a critical step toward accelerating improvement in type, quality, and access to data, regardless of whether these originate from clinical trials or from RW studies. However, so far, advances in transparency have been relatively restricted to clinical trials, and there remains a lack of similar expectations or standards of transparency concerning the generation and reporting of RW data. This perspective paper aims to highlight the need for transparency concerning RW studies, data, and evidence across health care sectors, to identify areas for improvement, and provide concrete recommendations and practices for the future. Specific issues are discussed from different stakeholder perspectives, culminating in recommended actions, from individual stakeholder perspectives, for improved RW study, data, and evidence transparency. Furthermore, a list of potential guidelines for consideration by stakeholders is proposed. While recommendations from different stakeholder perspectives are made, true transparency in the processes involved in the generation, reporting, and use of RW evidence will require a concerted effort from all stakeholders across health care sectors.

Capturing the patient experience in systemic lupus erythematosus: Are widely used measures fit-for-purpose and adherent to FDA PRO guidance recommendations?

BACKGROUND: The 2009 Food and Drug Administration (FDA) patient-reported outcome (PRO) guidance outlines characteristics of rigorous PRO-measure development. There are a number of widely used PRO measures for Systemic Lupus Erythematosus (SLE), but it is unknown how well the development processes of SLE PRO measures align with FDA guidance; including updated versions. The objective of this study was to assess how well the LupusQoL and LupusPRO, and corresponding updated versions, LupusQoL-US and LupusPROv1.8, align with Food and Drug Administration (FDA) 2009 patient-reported outcome (PRO) guidance. METHODS: LupusQoL and LupusPRO were selected as the most widely studied and used Lupus PROs in the UK and US. Original (LupusQoL (2007) and LupusQoL-US (2010)) and revised (LupusPROVv1.7 (2012) and LupusPROv1.8 (2018)) versions were reviewed. We used FDA PRO guidance to create evaluation criteria for key components: target population, concepts measured, measurement properties, documentation across the phases of content validity (item-generation and cognitive interviewing, separately) and other psychometric-property testing. Two reviewers abstracted data independently, compared results, and resolved discrepancies. RESULTS: For all measures, the target population was unclear as population characteristics (e.g., ethnicity, education, disease severity) varied, and/or were not consistently reported or not considered across the three phases (e.g., LupusQoL item-generation lacked male involvement, LupusPRO cognitive-interviewing population characteristics were not reported). The item-generation phase for both original measures was conducted with concepts elicited via patient-engagement interviews and item derivation from experts. Cognitive interviewing was conducted via patient feedback with limited item-tracking for original measures. In contrast, the revised measures assumed content validity. Other psychometric testing recommendations (reliability, construct validity, ability to detect change) were reported for both original and revised measures, except for ability to detect change for revised measures. CONCLUSIONS: The SLE PRO measures adhere to some but not all FDA PRO guidance recommendations. Limitations in processes and documentation of the study population, make it unclear for which target population(s) the current Lupus measures are fit-for-purpose.

A Useful and Sustainable Role for N-of-1 Trials in the Healthcare Ecosystem.

Clinicians and patients often try a treatment for an initial period to inform longer-term therapeutic decisions. A more rigorous approach involves N-of-1 trials. In these single-patient crossover trials, typically conducted in patients with chronic conditions, individual patients are given candidate treatments in a double-blinded, random sequence of alternating periods to determine the most effective treatment for that patient. However, to date, these trials are rarely done outside of research settings and have not been integrated into general care where they could offer substantial benefit. Designating this classical, N-of-1 trial design as type 1, there also are new and evolving uses of N-of-1 trials that we designate as type 2. In these, rather than focusing on optimizing treatment for chronic diseases when multiple approved choices are available, as is typical of type 1, a type 2 N-of-1 trial tests treatments designed specifically for a patient with a rare disease, to facilitate personalized medicine. While the aims differ, both types face the challenge of collecting individual-patient evidence using standard, trusted, widely accepted methods. To fulfill their potential for producing both clinical and research benefits, and to be available for wide use, N-of-1 trials will have to fit into the current healthcare ecosystem. This will require generalizable and accepted processes, platforms, methods, and standards. This also will require sustainable value-based arrangements among key stakeholders. In this article, we review opportunities, stakeholders, issues, and possible approaches that could support general use of N-of-1 trials and deliver benefit to patients and the healthcare enterprise. To assess and expand the benefits of N-of-1 trials, we propose multistakeholder meetings, workshops, and the generation of methods, standards, and platforms that would support wider availability and the value of N-of-1 trials.

Patient-reported outcomes in breast cancer FDA drug labels and review documents.

BACKGROUND: Patient-reported outcomes (PROs) can provide valuable information about drug benefit-risk tradeoffs from the patient perspective and are particularly important to patients with breast cancer due to its symptoms and adverse events from breast cancer treatments. The United States Food and Drug Administration (U.S. FDA) has acknowledged PROs as important approval endpoints used in clinical trials of cancer drugs. However, previous studies found that PROs are rarely mentioned in cancer drug labels, a widely used and trusted source of information about drugs. Our objectives were to compare PRO data reported in FDA labeling versus FDA medical review documents for breast cancer drugs approved in the U.S. between 2000 and 2019 to identify possible causes for PRO-data labeling exclusions. METHODS: We included new molecular entities (NMEs) and biologic license applications (BLAs) initially approved for breast cancer treatment by the FDA between 1/1/2000 and 12/31/2019. Product labeling and FDA medical review documents were collected from the FDA-Approved Drugs database (Drugs@FDA). From these resources, details on PRO measures used in trials, design of trials using PRO measures, PRO-endpoint status, analytical methods, and FDA reviewer comments regarding PRO measurement were extracted. RESULTS: Of 633 FDA-approved drugs, 13 were indicated for breast cancer treatment; none of their prescribing information contained information about PROs. However, 11 of 13 (85%) included PRO measures and endpoint information in FDA medical review documents. PRO measures were used in 14 different clinical trials, and FDA reviewers' comments regarding PRO measurement were related to lack of meaningfulness and clinical significance, lack of content validity, and inadequate analytical methods. CONCLUSIONS: Despite the importance of PROs to patients with breast cancer, PRO measures were only described in FDA medical review documents of breast cancer drugs, but not in drug product labeling. Therefore, it appears that PRO data are often collected in breast cancer trials, but have not been methodologically acceptable to FDA reviewers. Collaborative efforts between the FDA and industry are warranted to increase the number of breast cancer drug applications with appropriate use of PRO measures and endpoints.

Patient Centeredness in Hepatitis C Direct-Acting Antiviral Treatment Delivery to People Who Inject Drugs: A Scoping Review.

BACKGROUND AND OBJECTIVE: Patient-centered care (PCC) is crucial for value-based care. We aimed to assess PCC dimensions addressed in hepatitis C virus direct-acting antiviral treatment delivery to people who inject drugs. METHODS: We conducted a scoping review to identify the studies that described hepatitis C virus treatment delivery to people who inject drugs in the direct-acting antiviral treatment era. We analyzed the included studies against eight PCC dimensions: (1) access to care; (2) coordination and integration of care; (3) continuity and translation; (4) physical comfort; (5) information, education, and communication; (6) emotional support; (7) involvement of family and friends; and (8) respect for individual patient preferences, perceived needs, and values. Additionally, we assessed the use of patient-centered terminology and the recognition of PCC importance and its relevance to treatment outcomes. RESULTS: None of the identified 36 studies addressed all PCC dimensions (highest seven, lowest two). Our findings revealed that PCC dimensions are prioritized differently and addressed using different approaches and strategies. Studies that used PCC terminology referred to personalized activities, which does not imply comprehensive PCC. About one-third of the studies acknowledged the importance of patient centeredness and two-thirds recognized its relevance to treatment outcomes. CONCLUSIONS: Our findings suggest more engagement of people who inject drugs and comprehensive involvement of their families and friends in hepatitis C virus treatment journey, decisions, and outcomes. The recognition of PCC importance and its relevance to treatment outcomes in the analyzed studies emphasizes the need for more patient-centered hepatitis C virus treatment for people who inject drugs.

Medical costs of Alpha-1 antitrypsin deficiency-associated COPD in the United States.

BACKGROUND: There are limited data on economic aspects of the genetic variant of chronic obstructive pulmonary disease (COPD) in the context of the more prevalent form of COPD. The objective of this study was to isolate the healthcare resource utilization and economic burden attributable to the presence of a genetic factor among COPD patients with and without Alpha-1 Antitrypsin Deficiency (AATD), twelve months before and after their initial COPD diagnosis. METHODS: Retrospective analysis of OptumLabs® Data Warehouse claims (OLDW; 2000-2017). The OLDW is a comprehensive, longitudinal real-world data asset with de-identified lives across claims and clinical information. AATD-associated COPD cases were matched with up to 10 unique non-AATD-associated COPD controls. Healthcare resource use and costs were assigned into the following categories: office (OV), outpatient (OP), and emergency room visits (ER), inpatients stays (IP), prescription drugs (RX), and other services (OTH). A generalized linear model was used to estimate total pre- and post-index (initial COPD diagnosis) costs from a third-party payer's perspective (2018 USD) controlling for confounders. Healthcare resource utilization was estimated using a negative binomial regression. RESULTS: The study population consisted of 8881 patients (953 cases matched with 7928 controls). The AATD-associated COPD cohort had higher expenditures and use of office visits (OV) and other (OTH) services, as well as OV, outpatient (OP), emergency room (ER), and prescription drugs (RX) before and after the index date, respectively. Adjusted total all-healthcare cost ratios for AATD-associated COPD patients as compared to controls were 2.04 [95% CI: 1.60-2.59] and 1.98 [95% CI: 1.55-2.52] while the incremental cost difference totaled $6861 [95% CI: $3025 - $10,698] and $5772 [95% CI: $1940 - $9604] per patient before and after the index date, respectively. CONCLUSIONS: Twelve months before and after their initial COPD diagnosis, patients with AATD incur higher healthcare utilization costs that are double the cost of similar COPD patients without AATD. This study also suggests that increased costs of AATD-associated COPD are not solely attributable to augmentation therapy use. Future studies should further explore the relationship between augmentation therapy, healthcare resource use, and other AATD-associated COPD expenditures.

Defining Patient Engagement in Research: Results of a Systematic Review and Analysis: Report of the ISPOR Patient-Centered Special Interest Group.

OBJECTIVES: Lack of clarity on the definition of "patient engagement" has been highlighted as a barrier to fully implementing patient engagement in research. This study identified themes within existing definitions related to patient engagement and proposes a consensus definition of "patient engagement in research." METHODS: A systematic review was conducted to identify definitions of patient engagement and related terms in published literature (2006-2018). Definitions were extracted and qualitatively analyzed to identify themes and characteristics. A multistakeholder approach, including academia, industry, and patient representation, was taken at all stages. A proposed definition is offered based on a synthesis of the findings. RESULTS: Of 1821 abstracts identified and screened for eligibility, 317 were selected for full-text review. Of these, 169 articles met inclusion criteria, from which 244 distinct definitions were extracted for analysis. The most frequently defined terms were: "patient-centered" (30.5%), "patient engagement" (15.5%), and "patient participation" (13.4%). The majority of definitions were specific to the healthcare delivery setting (70.5%); 11.9% were specific to research. Among the definitions of "patient engagement," the most common themes were "active process," "patient involvement," and "patient as participant." In the research setting, the top themes were "patient as partner," "patient involvement," and "active process"; these did not appear in the top 3 themes of nonresearch definitions. CONCLUSION: Distinct themes are associated with the term "patient engagement" and with engagement in the "research" setting. Based on an analysis of existing literature and review by patient, industry, and academic stakeholders, we propose a scalable consensus definition of "patient engagement in research."

Peer Review and Transparency in Evidence-Source Selection in Value and Health Technology Assessment.

OBJECTIVES: Value and health technology assessment (V/HTA) is often used in clinical, access, and reimbursement decisions. V/HTA data-source selection may not be transparent, which is a necessary element for stakeholder understanding and trust and for fostering accountability among decision makers. Peer review is considered one mechanism for judging data trustworthiness. Our objective was (1) to use publicly available documentation of V/HTA methods to identify requirements for inclusion of peer-reviewed evidence sources, (2) to compare and contrast US and non-US approaches, and (3) to assess evidence sources used in published V/HTA reports. METHODS: Publicly available methods documentation from 11 V/HTA organizations in North America and Europe were manually searched and abstracted for descriptions of requirements and recommendations regarding search strategy and evidence-source selection. The bibliographies of a subset of V/HTA reports published in 2018 were manually abstracted for evidence-source types used in each. RESULTS: Heterogeneity in evidence-source retrieval and selection was observed across all V/HTA organizations, with more pronounced differences between US and non-US organizations. Not all documentation of organizations' methods address the evidence-source selection processes (7 of 11), and few explicitly reference peer-reviewed sources (3 of 11). Documentation of the evidence-source selection strategy was inconsistent across reports (6 of 13), and the level of detail provided varied across organizations. Some information on evidence-source selection was often included in confidential documentation and was not publicly available. CONCLUSIONS: Disparities exist among V/HTA organizations in requirements and guidance regarding evidence-source selection. Standardization of evidence-source selection strategies and documentation could help improve V/HTA transparency and has implications for decision making based on report findings.

Use of Pharmacy Quality Measures to Enhance Value-Based Performance Within the Military Health System.

INTRODUCTION: As the healthcare system shifts from fee-for service toward value-driven healthcare, interest has grown in medication-related quality metrics to evaluate quality and value within the healthcare system. While the Defense Health Agency (DHA) has taken steps to align healthcare quality measures across the enterprise, the extent to which DHA utilizes pharmacy quality measures (PQMs) or evaluates the quality of direct and purchased pharmacy care is unknown. MATERIALS AND METHODS: A comparison was made between existing PQMs utilized by DHA and all measures published and endorsed by the Pharmacy Quality Alliance (PQA), a recognized, PQM standard-setting organization. We also compared DHA PQMs to those used within the Medicare Part D Star Rating Program. RESULTS: DHA has implemented 10 (28%) of the 36 PQA measures available for evaluation as of August 2019. Of the five measures included in the 2020 CMS Part D Star Rating program, DHA has currently implemented four (80%) of the measures. DHA has implemented 3 of the 5 (60%) PQA CMS Display Measures, and 5 of 9 (56%) PQA CMS Patient Safety Report Measures that are not part of the Star Ratings, but that are used to benchmark and provide feedback to health plans. CONCLUSION: Opportunities exist within the DHA to leverage PQMs to evaluate the quality of pharmaceutical care, build trust with beneficiaries by increasing transparency, and maintain parity with the civilian healthcare system. Existing models and commercially available technology could be considered to rapidly operationalize the use of PQMs within the MHS.