The impacts of migraine on functioning: Results from two qualitative studies of people living with migraine.

OBJECTIVE: To describe the impact of migraine on functioning based on comprehensive data collection, analysis, and reporting of patients' experiences. BACKGROUND: Qualitative research conducted to understand patients' perspectives on living with migraine has often focused on narrow topics or specific groups of patients or has been selectively reported. METHODS: Qualitative interviews with 71 participants were conducted during two concept elicitation studies as part of the Migraine Clinical Outcome Assessment System (MiCOAS) project, an FDA grant-funded program designed to develop a core set of patient-centered outcome measures for migraine clinical trials. Participants self-reported being diagnosed with migraine by a healthcare professional and participated in semi-structured qualitative interviews about their experiences with the symptoms and impacts of migraine. Interview transcripts were coded to identify and define concepts, which were then grouped into broad domains based on conceptual similarities. RESULTS: A total of 66 concepts were identified: 12 for physical functioning, 16 for cognitive functioning, 10 for social role functioning, 19 for emotional and psychological functioning, and 9 related to migraine management. Participants described a complex and varied relationship between migraine attack symptoms and impacts on functioning. Impacts from migraine were further influenced by numerous contextual factors, such as people's individual social environments and the level of day-to-day demand for functioning they face. CONCLUSION: Findings showed that migraine impacted individual functioning in multiple ways and the nature of these impacts was dependent on social-contextual factors. The results are being used in the development of core measures designed to improve our understanding of the burden of migraine and the efficacy of migraine therapies. The results also offer new insights and raise new questions about migraine experience that can be used to guide future research.

Priority acute and preventive migraine treatment benefits: Results of the Migraine Clinical Outcome Assessment System (MiCOAS) qualitative study of people living with migraine.

BACKGROUND: There is renewed emphasis on including patients in determining, defining, and prioritizing outcomes for migraine treatment. OBJECTIVES: To obtain insights directly from people living with migraine on their priorities for treatment. METHODS: A total of 40 qualitative interviews were conducted as part of the Migraine Clinical Outcome Assessment System project, a United States Food and Drug Administration grant-funded program to develop a core set of patient-centered outcome measures for migraine clinical trials. Interviews included a structured exercise in which participants rank-ordered pre-defined lists of potential benefits for acute and preventive migraine therapy. The 40 study participants who reported being diagnosed with migraine by a clinician ranked the benefits and explained their rationale. RESULTS: Study participants consistently ranked either pain relief or absence of pain as their top priority for acute treatment. Relief/absence of other migraine symptoms and improved functioning were also prioritized. For preventive treatment, participants prioritized reductions in migraine frequency, symptom severity, and attack duration. Few differences were found between participants with episodic migraine and those with chronic migraine. However, participants with chronic migraine ranked "increased predictability of attacks" much higher than those with episodic migraine. Participants' rankings were influenced by prior expectations and experiences of migraine treatments, which caused many participants to deprioritize desired benefits as unrealistic. Participants also identified several additional priorities, including limited side-effects and reliable treatment efficacy in both acute and preventive treatments. CONCLUSION: The results showed the participants prioritized treatment benefits aligned with existing core clinical outcomes used in migraine research, but also valued benefits that are not typically assessed, such as predictability. Participants also deprioritized important benefits when they believed treatment was unlikely to deliver those outcomes.

Patient-reported outcome measures for individuals with temporomandibular joint disorders: a systematic review and evaluation.

OBJECTIVE: We used consensus-based, systematic protocols to evaluate the reliability and validity of patient-reported outcome measures (PROMs) for use in documenting treatment outcomes for temporomandibular disorders (TMDs). STUDY DESIGN: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we conducted a focused search of 5 literature databases resulting in a yield of 445 articles that qualified for full-text review. Our review identified 124 PROMs, from which we selected 19 directly related to symptoms of TMD including temporomandibular joint (TMJ) function. RESULTS: We abstracted data on 9 Consensus-based Standards of the selection of health Measurements INstruments (COSMIN) measurement properties and analyzed these data according to COSMIN criteria. Only 3 PROMs provided evidence for at least half of the COSMIN properties: Eight-item Jaw Function Limitations Scale, Oral Health Impact Profile (OHIP)-TMD (OHIP-TMD), and TMJ Ankylosis Specific Quality of Life Questionnaire. Only the OHIP-TMD provided evidence for properties essential to evaluating change over time: reliability, measurement error, and responsiveness. CONCLUSION: We believe these results can alert clinical practitioners to gaps in our knowledge about the most widely used PROMs in TMD practice, and identify topics requiring further study for clinical researchers.

Understanding the Influence and Impact of Stakeholder Engagement in Patient-centered Outcomes Research: a Qualitative Study.

BACKGROUND: Engaging patients and other stakeholders as partners in research offers promise in improving the relevance and usefulness of research findings. OBJECTIVE: To explore the influence and impact of patient and other stakeholder engagement on the planning and conduct of comparative effectiveness research studies. DESIGN: Qualitative study with virtual, hour-long semi-structured interviews. PARTICIPANTS: Fifty-eight researchers and fifty-one partners from a diverse purposeful sample of fifty-eight studies funded by the Patient-Centered Outcomes Research Institute (PCORI). APPROACH: Content and thematic analysis of interview data. KEY RESULTS: Described as an integral, long-term part of the research process, engagement influenced all aspects of the design and execution of studies. Partner influence was also dynamic and iterative, taking different forms over the course of the study. Across studies, we identified 387 discrete examples of influence and classified each as one of five types of influence, derived inductively from the interview data: co-producing, redirecting, refining, confirming, and limited. Most projects exhibited multiple types of influence, with 50 researchers and 41 partners reporting two or more types of influence within a project. Of the 387 examples of stakeholder influence, 306 had at least one reported impact on the study. Such impacts included changes to reflect the needs and preferences of patients or clinicians, as well as impacts on study feasibility, study quality, engagement scope or quality, and study relevance. Both researchers and partners identified multiple types of impact within projects, with 42 researchers and 38 partners reporting two or more types within a project. Because of these observable impacts, researchers and partners described engagement as worthwhile. CONCLUSIONS: Findings provide insights for funders and institutions supporting engagement, measurement efforts, and clinical researchers aiming to conduct engaged research and observe similar influences and impacts in their own studies.

Omissions of Care in Nursing Homes: A Uniform Definition for Research and Quality Improvement.

Omission of care in US nursing homes can lead to increased risk for harm or adverse outcomes, decreased quality of life for residents, and increased healthcare expenditures. However, scholars and policymakers in long-term care have taken varying approaches to defining omissions of care, which makes efforts to prevent them challenging. Subject matter experts and a broad range of nursing home stakeholders participated in iterative rounds of engagement to identify key concepts and aspects of omissions of care and develop a consensus-based definition that is clear, meaningful, and actionable for nursing homes. The resulting definition is "Omissions of care in nursing homes encompass situations when care-either clinical or nonclinical-is not provided for a resident and results in additional monitoring or intervention or increases the risk of an undesirable or adverse physical, emotional, or psychosocial outcome for the resident." This concise definition is grounded in goal-concordant, resident-centered care, and can be used for a variety quality improvement purposes and for research.

Omissions of Care in Nursing Home Settings: A Narrative Review.

OBJECTIVES: This review aims to (1) examine existing definitions of omissions of care in the healthcare environment and associated characteristics and (2) outline adverse events that may be attributable to omissions of care among nursing home populations. DESIGN: Nonsystematic review. A literature search for published articles on care omissions in nursing home settings and related adverse events was performed using the databases PubMed, Web of Science, EBSCO Academic Search Premier, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) until January 2019. Articles were excluded if they were published in a language other than English or included samples that were not relevant to nursing home settings. SETTINGS AND PARTICIPANTS: Adult samples in nursing home settings or settings likely to include nursing homes as part of the continuum of care. MEASURES: Articles must provide a definition of missed or omitted care relevant to nursing home settings or include adverse events that can be attributed to care omissions. RESULTS: From a total of 2155 articles retrieved, 34 were retained for thematic synthesis. Key themes included broad agreement that any delay or failure of care is an omission; diverse views on including consideration of risks or occurrence of adverse events within the definition; diverse approaches to including components of care delivery systems in the definition; recognition that care in nursing homes includes both clinical and psychosocial care; and awareness that insufficient or inadequate resources to meet care demands can cause omissions. For research on adverse events attributable to omissions, 327 of 8385 articles were included for review. Nineteen adverse events were identified and omissions contributing to their incidence are highlighted. CONCLUSIONS/IMPLICATIONS: Definitions of omissions of care for nursing homes vary in scope and level of detail. Substantial evidence connects omissions of care with an array of adverse events in nursing home populations.

What motivates patients and caregivers to engage in health research and how engagement affects their lives: Qualitative survey findings.

BACKGROUND: US research organizations increasingly are supporting patient and stakeholder engagement in health research with a goal of producing more useful, relevant and patient-centered evidence better aligned with real-world clinical needs. The Patient-Centered Outcomes Research Institute (PCORI) engages patients, family caregivers and other health-care stakeholders, including clinicians, payers and policymakers, as active partners in prioritizing, designing, conducting and disseminating research as a key strategy to produce useful evidence for health-care decision making. OBJECTIVE: To inform effective engagement practices and policies, we sought to understand what motivates patients and caregivers to engage as partners on PCORI-funded research projects and how such engagement changed their lives. METHODS: We conducted thematic analysis of open-ended survey responses from 255 patients, family caregivers and individuals from advocacy and community-based organizations who engaged as partners on 139 PCORI-funded research projects focusing on a range of health conditions. RESULTS: Partners' motivations for engaging in research were oriented primarily towards benefiting others, including a desire to improve patients' lives and to support effective health-care interventions. In addition to feeling they made a positive difference, many partners reported direct benefits from engagement, such as new relationships and improved health habits. DISCUSSION AND CONCLUSIONS: By identifying patient and caregiver motivations for engaging in research partnerships and what they get out of the experience, our study may help research teams and organizations attract partners and foster more satisfying and sustainable partnerships. Our findings also add to evidence that engagement benefits the people involved as partners, strengthening the case for more widespread engagement.

An informed public's views on reducing antibiotic overuse.

OBJECTIVE: To understand public attitudes about and recommendations to address antibiotic overuse by employing public deliberation (a method for eliciting informed input on value-laden issues). DATA SOURCES/STUDY SETTING: Participants in 24 Community Deliberation groups (CD; n = 263), four Citizens' Panel groups (CP; n = 96), and a control group (n = 348). Data were collected in 2012 in four U.S. STUDY DESIGN: Using mixed methods, we analyzed quantitative and qualitative data from a randomized control trial. DATA COLLECTION/EXTRACTION METHODS: Using pre/postdeliberation surveys, we compared CD and CP participant attitude changes regarding antibiotic use to the control group. We analyzed deliberation transcripts using qualitative techniques to provide context for survey results. PRINCIPAL FINDINGS: Compared to control group participants, CD and CP participants had a larger postdeliberation shift in attitudes toward support of government limits on when doctors can prescribe antibiotics. Participants described unawareness about antibiotic overuse and called for education. When discussing prescription limits, participants debated tensions between preserving patient/doctor autonomy and protecting society from antibiotic-related harms. Participants saw patient, physician, and government roles in antibiotic stewardship policies/programs. CONCLUSION: When informed about individual and social consequences of antibiotic overuse, patients may be more receptive to antibiotic prescription limits. Community-physician-government partnerships are needed to create solutions.

Hopeful and Concerned: Public Input on Building a Trustworthy Medical Information Commons.

A medical information commons (MIC) is a networked data environment utilized for research and clinical applications. At three deliberations across the U.S., we engaged 75 adults in two-day facilitated discussions on the ethical and social issues inherent to sharing data with an MIC. Deliberants made recommendations regarding opt-in consent, transparent data policies, public representation on MIC governing boards, and strict data security and privacy protection. Community engagement is critical to earning the public's trust.

Public Mistrust of the U.S. Health Care System's Profit Motives: Mixed-Methods Results from a Randomized Controlled Trial.

BACKGROUND: Decision makers are increasingly tasked with reducing health care costs, but the public may be mistrustful of these efforts. Public deliberation helps gather input on these types of issues by convening a group of diverse individuals to learn about and discuss values-based dilemmas. OBJECTIVE: To explore public perceptions of health care costs and how they intersect with medical mistrust. DESIGN AND PARTICIPANTS: This mixed-methods study analyzed data from a randomized controlled trial including four public deliberation groups (n = 96) and a control group (n = 348) comprising English-speaking adults aged 18 years and older. Data were collected in 2012 in four U.S. regions. APPROACH: We used data from four survey items to compare attitude shifts about costs among participants in deliberation groups to participants in the control group. We qualitatively analyzed deliberation transcripts to identify themes related to attitude shifts and to provide context for quantitative results about attitude shifts. KEY RESULTS: Deliberation participants were significantly more likely than control group participants to agree that doctors and patients should consider cost when making treatment decisions (ß = 0.59; p < 0.01) and that people should consider the effect on group premiums when making treatment decisions (ß = 0.48; p < 0.01). Qualitatively, participants mistrusted the health care system's profit motives (e.g., that systems prioritize making money over patient needs); however, after grappling with patient/doctor autonomy and learning about and examining their own views related to costs during the process of deliberation, they largely concluded that payers have the right to set some boundaries to curb costs. CONCLUSIONS: Individuals who are informed about costs may be receptive to boundaries that reduce societal health care costs, despite their mistrust of the health care system's profit motives, especially if decision makers communicate their rationale in a transparent manner. Future work should aim to develop transparent policies and practices that earn public trust.

Setting Boundaries: Public Views on Limiting Patient and Physician Autonomy in Health Care Decisions.

We obtained and qualitatively analyzed input from more than nine hundred citizens during seventy-six public deliberation sessions about patient and physician autonomy in decision making, setting health care boundaries, and the tensions among competing social values. Generally, participants resisted interference with the patient-physician relationship and believed strongly in the freedom of patient and physician to control individual medical decisions. However, during deliberation participants identified two situations where boundaries and regulations in health care were more acceptable: protecting people from harm and allocating limited resources. The core value of individual freedom was tempered in varying degrees by the values of concern for the greater good and fairness in allocating resources. Where tensions between values emerged, participants used different concepts-including accountability, transparency, trust, personal responsibility, and moral obligation-to navigate trade-offs. Fairly balancing the public's desire to protect individual freedom with their sense of responsibility for protecting the common good may be the key to developing acceptable, workable policies that promote evidence-based medical practice.

Understanding An Informed Public's Views On The Role Of Evidence In Making Health Care Decisions.

Policy makers and practitioners increasingly believe that medical evidence plays a critical role in improving care and health outcomes and lowering costs. However, public understanding of the role of evidence-based care may be different. Public deliberation is a process that convenes diverse citizens and has them learn about and consider ethical or values-based dilemmas and weigh alternative views. The Community Forum Deliberative Methods Demonstration project, sponsored by the Agency for Healthcare Research and Quality, obtained informed public views on the role of evidence in health care decisions through seventy-six deliberative groups involving 907 people overall, in the period August-November 2012. Although participants perceived evidence as being essential to high-quality care, they also believed that personal choice or clinical judgment could trump evidence. They viewed doctors as central figures in discussing evidence with patients and key arbiters of whether to follow evidence in individual cases. They found evidence of harm to individuals or the community to be more compelling than evidence of effectiveness. These findings indicate that increased public understanding of evidence can play an important role in advancing evidence-based care by helping create policies that better reflect the needs and values of the public.

Effectiveness of public deliberation methods for gathering input on issues in healthcare: Results from a randomized trial.

UNLABELLED: Public deliberation elicits informed perspectives on complex issues that are values-laden and lack technical solutions. This Deliberative Methods Demonstration examined the effectiveness of public deliberation for obtaining informed public input regarding the role of medical evidence in U.S. healthcare. We conducted a 5-arm randomized controlled trial, assigning participants to one of four deliberative methods or to a reading materials only (RMO) control group. The four deliberative methods reflected important differences in implementation, including length of the deliberative process and mode of interaction. The project convened 76 groups between August and November 2012 in four U.S. LOCATIONS: Chicago, IL; Sacramento, CA; Silver Spring, MD; and Durham, NC, capturing a sociodemographically diverse sample with specific attention to ensuring inclusion of Hispanic, African-American, and elderly participants. Of 1774 people recruited, 75% participated: 961 took part in a deliberative method and 377 participants comprised the RMO control group. To assess effectiveness of the deliberative methods overall and of individual methods, we evaluated whether mean pre-post changes on a knowledge and attitude survey were statistically different from the RMO control using ANCOVA. In addition, we calculated mean scores capturing participant views of the impact and value of deliberation. Participating in deliberation increased participants' knowledge of evidence and comparative effectiveness research and shifted participants' attitudes regarding the role of evidence in decision-making. When comparing each deliberative method to the RMO control group, all four deliberative methods resulted in statistically significant change on at least one knowledge or attitude measure. These findings were underscored by self-reports that the experience affected participants' opinions. Public deliberation offers unique potential for those seeking informed input on complex, values-laden topics affecting broad public constituencies.