Researchers, patients, and other stakeholders' perspectives on challenges to and strategies for engagement.

BACKGROUND: There is growing interest in patient and stakeholder engagement in research, yet limited evidence about effective methods. Since 2012, the Patient-Centered Outcomes Research Institute (PCORI) has funded patient-centered comparative effectiveness research with a requirement for engaging patients and other stakeholders as research partners in study planning, conduct, and dissemination. This requirement, unique among large healthcare research funders in the US, provides an opportunity to learn about challenges encountered and specific strategies used by PCORI-funded study teams. The primary objective of this study is to describe -- from the perspective of PCORI investigators and research partners-the most common engagement challenges encountered in the first two years of the projects and promising strategies to prevent and overcome these challenges. METHODS: Descriptive information about investigators, partners, and their engagement was collected from investigators via annual (N = 235) and mid-year (N = 40) project progress reporting to PCORI, and from their partners (N = 260) via voluntary survey. Qualitative data were analyzed using content and thematic analyses. RESULTS: Investigators and partners most often described engagement challenges in three domains: (1) infrastructure to support engagement, (2) building relationships, and (3) maintaining relationships. Infrastructure challenges related to financial and human resources, including funding support and dedicated staff, identifying diverse groups of partners, and partners' logistical needs. Challenges for both building and maintaining relationships encompass a variety of aspects of authentic, positive interactions that facilitate mutual understanding, full participation, and genuine influence on the projects. Strategies to prevent or mitigate engagement challenges also corresponded overall to the same three domains. Both groups typically described strategies more generally, with applicability to a range of challenges rather than specific actions to address only particular challenges. CONCLUSION: Meaningful engagement of patients and other stakeholders comes with challenges, as does any innovation in the research process. The challenges and promising practices identified by these investigators and partners, related to engagement infrastructure and the building and maintenance of relationships, reveal actionable areas to improve engagement, including organizational policies and resources, training, new engagement models, and supporting engagement by viewing it as an investment in research uptake and impact.

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.

Researchers, Patients, and Stakeholders Evaluating Comparative-Effectiveness Research: A Mixed-Methods Study of the PCORI Reviewer Experience.

OBJECTIVES: The Patient-Centered Outcomes Research Institute (PCORI) includes patients and stakeholders alongside scientists in reviewing research applications using unique review criteria including patient-centeredness and patient and/or stakeholder engagement. To support extension of this unique collaborative model to other funders, information from the reviewers on the review process is needed to understand how scientists and nonscientists evaluate research proposals together. Thus, this study aimed to describe reviewers' perspectives of the interactions during the in-person review panel; to examine the value and challenges of including scientists, patients, and stakeholders together; and to understand the perceived importance of PCORI's review criteria. METHODS: This study utilized anonymous, cross-sectional surveys (N = 925 respondents from 5 funding cycles: 470 scientists, 217 patients, 238 stakeholders; survey completion rates by cycle: 70-89%) and group interviews (N = 18). RESULTS: Reviewers of all types describe PCORI Merit Review as respectful, balanced, and one of reciprocal influence among different reviewer types. Reviewers indicate strong support and value of input from all reviewer types, receptivity to input from others, and the panel chair's incorporation of all views. Patients and stakeholders provide real-world perspectives on importance to patients, research partnership plans, and study feasibility. Challenges included concerns about a lack of technical expertise of patient/stakeholder reviewers and about scientists dominating conversations. The most important criterion for assigning final review scores was technical merit-either alone or in conjunction with patient-centeredness or patient/ stakeholder engagement. CONCLUSIONS: PCORI Merit Reviewers' self-reports indicate that the perspectives of different reviewer types are influential in panel discussions and Merit Review outcomes.

Daily Marital Tension and Symptom Severity in Older Adults With Diabetes or Osteoarthritis.

Background: Greater marital quality is associated with better psychological and physical health. The quality of daily marital interactions is likely to be especially important for individuals with chronic illness, but this question has received little attention. Purpose: Using data from two diary studies, the current study examined whether individuals with chronic illness would experience more severe symptoms on days with more marital tension due in part to greater negative affect on those days. Methods: The samples included individuals with knee osteoarthritis (OA, N = 145) or type 2 diabetes mellitus (T2DM, N = 129) and their spouses. Participants reported on daily marital interaction quality, affect, and symptom severity (patients only) for 22 days (knee OA) or 24 days (T2DM). Separate multilevel models were run for patients and spouses, controlling for the partner's marital tension and negative affect as well as both partners' daily marital enjoyment and positive affect. We examined same-day and across-day associations. Results: For individuals with T2DM or knee OA, more severe symptoms on days with more marital tension were due in part to their greater negative affect on those days. Individuals with knee OA who experienced more pain had more negative affect and marital tension the next day. Conclusions: Negative marital interactions may exacerbate physical symptoms. Effects of daily marital tension likely accumulate over time and have long-term implications for health.

Spouse confidence and physical function among adults with osteoarthritis: The mediating role of spouse responses to pain.

OBJECTIVE: This study of adults with osteoarthritis and their spouses examined spouse responses to patients' pain as mediators of the associations between spouse confidence in patients' ability to manage arthritis and improvements in patients' physical function and activity levels over time. METHOD: Participants were 152 older adults with knee osteoarthritis and their spouses. In-person interviews were conducted with patients and spouses (separately) at 3 time points: baseline (Time[T] 1), 6 months after baseline (T2), and 18 months after baseline (T3). At each time point, patients reported their self-efficacy for arthritis management, functional limitations, and time spent in physical activity; spouses reported their confidence for patients' arthritis management and their empathic, solicitous, and punishing responses to patients' pain. Multiple mediation regression models were used to examine hypothesized associations across 2 distinct time frames: 6 months (T1-T2) and 12 months (T2-T3). RESULTS: Across 6 months, spouse confidence was indirectly related to improvements in patients' functional limitations and activity levels through increased empathic responses to patient pain. Across 12 months, spouse confidence was indirectly related to improvements in patients' functional limitations and activity levels through decreased solicitous responses to patient pain. CONCLUSIONS: This study adds to the literature on spousal influences on health by identifying 2 spouse behaviors that help to explain how spouse confidence for patients' illness management translates into improvements in patients' physical health over time. Findings can inform the development of couple-focused illness management interventions aiming to increase the positive influence of the spouse on patients' health behaviors and outcomes. (PsycINFO Database Record

Effects of change in arthritis severity on spouse well-being: The moderating role of relationship closeness.

The severity of a patient's illness may be detrimental for the psychological well-being of the spouse, especially for those in a particularly close relationship. Using 2 waves of data collected from a sample of 152 knee osteoarthritis (OA) patients and their spouses, we examined associations between change in patients' illness severity and change in 3 indicators of spouses' well-being (positive affect, depressive symptoms, and life satisfaction) over a 6-month period. We also tested the hypothesis that spouses' perceived relationship closeness with the patient would moderate these associations. Consistent with our prediction, a high level of relationship closeness exacerbated the negative impact of increases in patient illness severity on spouses' positive affect and depressive symptoms over 6 months. Spouses' life satisfaction declined when patients became more ill, regardless of level of relationship closeness. Our findings highlight the value of examining change in illness as a predictor of change in spouse well-being and the potential downside of relationship closeness for couples living with chronic illness.

Older adults' beliefs about the timeline of type 2 diabetes and adherence to dietary regimens.

The common-sense model posits that behavioural coping with illness is shaped by a complex combination of individuals' abstract and concrete beliefs about their illness. We investigated this theoretical assumption in a study of 116 older adults diagnosed with type 2 diabetes who completed in-person interviews at baseline and six and 12 months later. Specifically, we examined (1) the interaction of patients' abstract and concrete beliefs about the timeline of their diabetes as a predictor of change in adherence to a healthy diet and (2) whether these interactive effects differ among male and female patients. Abstract timeline beliefs were conceptualised as those pertaining to disease duration; concrete timeline beliefs were conceptualised as those pertaining to variability of disease symptoms (i.e. symptoms are stable versus fluctuating). As predicted, duration beliefs were positively associated with improvement in adherence among patients who viewed disease symptoms as stable, but not among those who viewed symptoms as variable. When gender was considered, these interactive effects were observed among male (but not female) patients. Findings revealed that the behavioural effects of men's abstract knowledge about their diabetes were conditioned by their concrete representations of the disease, suggesting a bottom-up process of influence with implications for intervention.

Spouses' attempts to regulate day-to-day dietary adherence among patients with type 2 diabetes.

OBJECTIVE: To investigate daily dietary adherence and diabetes-specific distress among older adults with type 2 diabetes mellitus (T2DM) as a function of spouses' diet-related support and diet-related control (persuasion and pressure) and whether these daily processes differ among couples who do and do not appraise responsibility for managing T2DM as shared. METHODS: End-of-day diaries were completed by 126 couples in which one partner had T2DM (patient) and the other did not (spouse). Using electronic diary methods, each partner independently recorded data for 24 consecutive days (patients recorded their day's dietary adherence and diabetes-specific distress; spouses recorded their day's involvement in patients' dietary management). To assess dietary adherence, patients reported the extent to which they followed dietary recommendations that day with items from the Summary of Diabetes Self-Care Activities Measure. To assess diabetes-specific distress, patients reported the extent to which they worried about diabetes that day using items from the Problem Areas in Diabetes (PAID) scale. RESULTS: Multilevel modeling revealed that, relative to the prior day, spouses' diet-related support was associated with increases in patients' adherence whereas diet-related persuasion and pressure were associated with decreases in adherence; spouses' pressure was associated with increases in patients' diabetes-specific distress. When partners appraised responsibility for managing T2DM as shared, support was associated with decreases in diabetes-specific distress; pressure was associated with decreases in adherence. CONCLUSIONS: Our findings offer insight into partners' day-to-day disease-related interactions and identify those that are likely to be beneficial versus detrimental for patients' physical and psychological health.

Setbacks in diet adherence and emotional distress: a study of older patients with type 2 diabetes and their spouses.

OBJECTIVES: We investigated patients' difficulties in managing their diet (i.e. diet setbacks) and associations with change in disease-specific and general emotional distress (diabetes distress and depressive symptoms) among patients with type 2 diabetes and their spouses. METHOD: Data for this study were collected in couples' homes (N=115 couples) using structured interviews and self-administered questionnaires at three time points: baseline (T1), six months after baseline (T2) and 12 months after baseline (T3). RESULTS: Patients' diet setbacks were associated with an increase in their diabetes distress in the shorter-term (over six months). Patients' diet setbacks were not associated with longer-term change in diabetes distress or with change in depressive symptoms at either time point (six months or one year). In contrast, spouses' perceptions of patients' diet setbacks were associated with increases in their own diabetes distress at both time points (over six months and one year), and also with an increase in their depressive symptoms in the longer-term (over one year). CONCLUSION: Findings reveal detrimental consequences of patients' diet nonadherence for emotional well-being that extend to the well-being of their spouses.