Older adult participation in cancer clinical trials: A systematic review of barriers and interventions.

Cancer is a disease of aging and, as the world's population ages, the number of older persons with cancer is increasing and will make up a growing share of the oncology population in virtually every country. Despite this, older patients remain vastly underrepresented in research that sets the standards for cancer treatments. Consequently, most of what we know about cancer therapeutics is based on clinical trials conducted in younger, healthier patients, and effective strategies to improve clinical trial participation of older adults with cancer remain sparse. For this systematic review, the authors evaluated published studies regarding barriers to participation and interventions to improve participation of older adults in cancer trials. The quality of the available evidence was low and, despite a literature describing multifaceted barriers, only one intervention study aimed to increase enrollment of older adults in trials. The findings starkly amplify the paucity of evidence-based, effective strategies to improve participation of this underrepresented population in cancer trials. Within these limitations, the authors provide their opinion on how the current cancer research infrastructure must be modified to accommodate the needs of older patients. Several underused solutions are offered to expand clinical trials to include older adults with cancer. However, as currently constructed, these recommendations alone will not solve the evidence gap in geriatric oncology, and efforts are needed to meet older and frail adults where they are by expanding clinical trials designed specifically for this population and leveraging real-world data.

Factors influencing the participation of pregnant and lactating women in clinical trials: A mixed-methods systematic review.

BACKGROUND: Poor representation of pregnant and lactating women and people in clinical trials has marginalised their health concerns and denied the maternal-fetal/infant dyad benefits of innovation in therapeutic research and development. This mixed-methods systematic review synthesised factors affecting the participation of pregnant and lactating women in clinical trials, across all levels of the research ecosystem. METHODS AND FINDINGS: We searched 8 databases from inception to 14 February 2024 to identify qualitative, quantitative, and mixed-methods studies that described factors affecting participation of pregnant and lactating women in vaccine and therapeutic clinical trials in any setting. We used thematic synthesis to analyse the qualitative literature and assessed confidence in each qualitative review finding using the GRADE-CERQual approach. We compared quantitative data against the thematic synthesis findings to assess areas of convergence or divergence. We mapped review findings to the Theoretical Domains Framework (TDF) and Capability, Opportunity, and Motivation Model of Behaviour (COM-B) to inform future development of behaviour change strategies. We included 60 papers from 27 countries. We grouped 24 review findings under 5 overarching themes: (a) interplay between perceived risks and benefits of participation in women's decision-making; (b) engagement between women and the medical and research ecosystems; (c) gender norms and decision-making autonomy; (d) factors affecting clinical trial recruitment; and (e) upstream factors in the research ecosystem. Women's willingness to participate in trials was affected by: perceived risk of the health condition weighed against an intervention's risks and benefits, therapeutic optimism, intervention acceptability, expectations of receiving higher quality care in a trial, altruistic motivations, intimate relationship dynamics, and power and trust in medicine and research. Health workers supported women's participation in trials when they perceived clinical equipoise, had hope for novel therapeutic applications, and were convinced an intervention was safe. For research staff, developing reciprocal relationships with health workers, having access to resources for trial implementation, ensuring the trial was visible to potential participants and health workers, implementing a woman-centred approach when communicating with potential participants, and emotional orientations towards the trial were factors perceived to affect recruitment. For study investigators and ethics committees, the complexities and subjectivities in risk assessments and trial design, and limited funding of such trials contributed to their reluctance in leading and approving such trials. All included studies focused on factors affecting participation of cisgender pregnant women in clinical trials; future research should consider other pregnancy-capable populations, including transgender and nonbinary people. CONCLUSIONS: This systematic review highlights diverse factors across multiple levels and stakeholders affecting the participation of pregnant and lactating women in clinical trials. By linking identified factors to frameworks of behaviour change, we have developed theoretically informed strategies that can help optimise pregnant and lactating women's engagement, participation, and trust in such trials.

Decision-making and autonomy among participants in early-phase cancer immunotherapy trials: a qualitative study.

BACKGROUND: Participants considering early-phase cancer clinical trials (CTs) need to understand the unique risks and benefits prior to providing informed consent. This qualitative study explored the factors that influence patients' decisions about participating in early-phase cancer immunotherapy CTs through the ethical lens of relational autonomy. METHODS: Using an interpretive descriptive design, interviews were conducted with 21 adult patients with advanced cancer who had enrolled in an early-phase CT. Data was analyzed using relational autonomy ethical theory and constant comparative analysis. RESULTS: The extent to which participants perceived themselves as having a choice to participate in early-phase cancer immunotherapy CTs was a central construct. Perceptions of choice varied according to whether participants characterized their experience as an act of desperation or as an opportunity to receive a novel treatment. Intersecting psychosocial and structural factors influenced participants' decision making about participating in early-phase cancer immunotherapy trials. These relational factors included: (1) being provided with hope; (2) having trust; (3) having the ability to withdraw; and (4) timing constraints. CONCLUSIONS: Findings highlight the continuum of perceived choice that exists among patients with cancer when considering participation in early-phase cancer immunotherapy CTs. All participants were interpreted as exhibiting some degree of relational autonomy within the psychosocial and structural context of early-phase CT decision making. This study offers insights into the intersection of cancer care delivery, personal beliefs and values, and established CT processes and structures that can inform future practices and policies associated with early-phase cancer immunotherapy CTs to better support patients in making informed decisions.

Using brief reflections to capture and evaluate end-user engagement: a case example using the COMPASS study.

BACKGROUND: Use of participatory research methods is increasing in research trials. Once partnerships are established with end-users, there is less guidance about processes research teams can use to successfully incorporate end-user feedback. The current study describes the use of a brief reflections process to systematically examine and evaluate the impact of end-user feedback on study conduct. METHODS: The Comparative Effectiveness of Trauma-Focused and Non-Trauma- Focused Treatment Strategies for PTSD among those with Co-Occurring SUD (COMPASS) study was a randomized controlled trial to determine the effectiveness of trauma-focused psychotherapy versus non-trauma-focused psychotherapy for Veterans with co-occurring posttraumatic stress disorder and substance use disorder who were entering substance use treatment within the Department of Veterans Affairs. We developed and paired a process of "brief reflections" with our end-user engagement methods as part of a supplemental evaluation of the COMPASS study engagement plan. Brief reflections were 30-minute semi-structured discussions with the COMPASS Team following meetings with three study engagement panels about feedback received regarding study issues. To evaluate the impact of panel feedback, 16 reflections were audio-recorded, transcribed, rapidly analyzed, and integrated with other study data sources. RESULTS: Brief reflections revealed that the engagement panels made recommended changes in eight areas: enhancing recruitment; study assessment completion; creating uniformity across Study Coordinators; building Study Coordinator connection to Veteran participants; mismatch between study procedures and clinical practice; therapist skill with patients with active substance use; therapist burnout; and dissemination of study findings. Some recommendations positively impact study conduct while others had mixed impact. Reflections were iterative and led to emergent processes that included revisiting previously discussed topics, cross-pollination of ideas across panels, and sparking solutions amongst the Team when the panels did not make any recommendations or recommendations were not feasible. CONCLUSIONS: When paired with end-user engagement methods, brief reflections can facilitate systematic examination of end-user input, particularly when the engagement strategy is robust. Reflections offer a forum of accountability for researchers to give careful thought to end-user recommendations and make timely improvements to the study conduct. Reflections can also facilitate evaluation of these recommendations and reveal end-user-driven strategies that can effectively improve study conduct. TRIAL REGISTRATION: ClinicalTrials.gov (NCT04581434) on October 9, 2020; https://clinicaltrials.gov/ct2/show/study/NCT04581434?term=NCT04581434&draw=2&rank=1 .

Dose‒Response Effects of Patient Engagement on Anxiety and Depression in a Cognitive-Behavioral Intervention: Secondary Analysis of a Pilot Randomized Controlled Trial and a Clinical Controlled Trial.

Understanding the dose‒response relationship between patient engagement in cognitive behavioral therapy (CBT) and health outcomes is critical for developing and implementing effective CBT programs. In studies of CBT interventions, patient engagement is measured only at a single time point, and outcomes are typically assessed before and after the intervention. Examination of the dose‒response relationship between patient engagement in CBT and outcomes is limited. It is unclear whether a dose‒response relationship exists between patient engagement in on-site CBT intervention and anxiety and depression in people living with HIV (PLWH). If present, does this dose‒response relationship occur early or later in the intervention? This study aimed to address this gap by examining the dose‒response relationships between patient engagement and anxiety and depression in CBT interventions among PLWH. Utilizing data from a pilot randomized trial (10 participants) and a clinical controlled trial (70 participants), our secondary analysis spans baseline, 3-month, and 6-month assessments. Both trials implemented the nurse-led CBT intervention. Cluster analysis identified two groups based on on-site attendance and WeChat activity. Patients with good adherence (6-10 times) of on-site attendance exhibited significantly lower anxiety and depression scores at 3 months (ß = 1.220, P = 0.047; ß = 1.270, P = 0.019), with no significant differences observed at 6 months. WeChat activity did not significantly influence anxiety or depression scores. The findings highlight a significant short-term dose‒response relationship, endorsing nurse-led CBT interventions for mental health in PLWH. Organizational strategies should focus on incentivizing and facilitating patient engagement, particularly through enhancing WeChat features.

The Patient Activation Measure-13 (PAM-13) in an oncology patient population: psychometric properties and dimensionality evaluation.

BACKGROUND: Accurate assessment and enhancement of health-related skills among oncology patients are pivotal for optimizing cancer care. The Patient Activation Measure (PAM-13), a questionnaire designed to reflect an individual's knowledge, skills, and confidence in self-healthcare management, has been validated across diverse countries and settings. Concerns have been raised regarding the cross-situational applicability, as patients with specific diseases and cultural backgrounds interpret questionnaire items differently. This study aimed to examine the structural validity and psychometric properties of the PAM-13 in an oncological patient cohort. METHODS: Baseline data from a longitudinal non-randomized controlled study involving cancer out-patients (n = 1,125) from Comprehensive Cancer Centres in Southern Germany were analysed. The German version of the PAM-13 was employed. With classical test and item response theory methods data quality, reliability, convergent and structural validity, as well as psychometric properties were assessed. Exploratory (EFA) and confirmatory factor analyses (CFA) were employed to investigate the postulated unidimensionality of the underlying construct. With a partial credit model (PCM) we examined item fit, targeting, local independence and differential item functioning. RESULTS: Participants were predominantly female (73.0%) with a breast cancer diagnosis (41.3%). While items were generally well-accepted, ceiling effects were observed and a high mean PAM-13 score (69.7, SD = 14.2) was noted, potentially compromising responsiveness to interventions. Reliability was adequate (Cronbach's α = 0.81), person and item separation reliability were good to excellent (0.81 and 0.99, respectively). Explorations of the unidimensionality of the construct (EFA, CFA, PCM) yielded inconclusive results, hinting towards a two-factor solution. Item difficulty rankings deviated from the original. No differential item functioning was identified, and local independence was confirmed. CONCLUSIONS: While the PAM-13 serves as a valuable instrument for comprehending and promoting health-related skills in cancer patients, the identification of ceiling effects, disordered item-difficulty rankings, and inconclusive findings regarding unidimensionality contribute to the expanding body of evidence, emphasizing the dependency of PAM-13's validity and reliability on distinctive characteristics within the population under investigation. Future research should prioritize refining or adding PAM-13 items to better capture the specific health-related challenges within diverse populations, paving the way for more effective patient engagement strategies in oncology. TRIAL REGISTRATION NUMBER: DRKS00021779.

Interactive digital tools to support empowerment of people with cancer: a systematic literature review.

PURPOSE: To identify and synthesise interactive digital tools used to support the empowerment of people with cancer and the outcomes of these tools. METHODS: A systematic literature review was conducted using PubMed, CINAHL, Web of Science, Cochrane, Eric, Scopus, and PsycINFO databases in May 2023. Inclusion criteria were patient empowerment as an outcome supported by interactive digital tools expressed in study goal, methods or results, peer-reviewed studies published since 2010 in cancer care. Narrative synthesis was applied, and the quality of the studies was assessed following Joanna Briggs Institute checklists. RESULTS: Out of 1571 records screened, 39 studies published in 2011-2022 with RCT (17), single-arm trial (15), quasi-experimental (1), and qualitative designs (6) were included. A total of 30 interactive digital tools were identified to support empowerment (4) and related aspects, such as self-management (2), coping (4), patient activation (9), and self-efficacy (19). Significant positive effects were found on empowerment (1), self-management (1), coping (1), patient activation (2), and self-efficacy (10). Patient experiences were positive. Interactivity occurred with the tool itself (22), peers (7), or nurses (7), physicians (2), psychologists, (2) or social workers (1). CONCLUSION: Interactive digital tools have been developed extensively in recent years, varying in terms of content and methodology, favouring feasibility and pilot designs. In all of the tools, people with cancer are either active or recipients of information. The research evidence indicates positive outcomes for patient empowerment through interactive digital tools. Thus, even though promising, there still is need for further testing of the tools.

Oncology patients' willingness to report their medication safety concerns from home: a qualitative study.

PURPOSE: Oncology patients often struggle to manage their medications and related adverse events during transitions of care. They are expected to take an active role in self-monitoring and timely reporting of their medication safety events or concerns to clinicians. The purpose of this study was to explore the factors influencing oncology patients' willingness to report adverse events or concerns related to their medication after their transitions back home. METHODS: A qualitative interview study was conducted with adult patients with breast, prostate, lung, or colorectal cancer who experienced care transitions within the previous year. A semi-structured interview guide was developed to understand patients' perceptions of reporting mediation-related safety events or concerns from home. All interviews were conducted via phone calls, recorded, and transcribed for thematic data analysis. RESULTS: A total of 41 individuals participated in the interviews. Three main themes and six subthemes emerged, including patients' perceived relationship with clinicians (the quality of communication and trust in clinicians), perceived severity of adverse medication events (perceived severe vs. non-severe events), and patient activation in self-management (self-efficacy in self-management and engagement in monitoring health outcomes). CONCLUSION: The patient-clinician relationship significantly affects patients' reporting behaviors, which can potentially interact with other factors, including the severity of adverse events. It is important to engage oncology patients in medication safety self-reporting from home by enhancing health communication, understanding patients' perceptions of severe events, and promoting patient activation. By addressing these efforts, healthcare providers should adopt a more patient-centered approach to enhance the overall quality and safety of oncological care.

The relationship between medication beliefs, patient activation, and self-rated health in patients taking oral anticancer agents.

PURPOSE: Patients on oral anticancer agent (OAA) therapies have the autonomy to manage their cancer treatments in home settings. However, patients may not have adequate knowledge, confidence, or ability to effectively manage OAA-related consequences, which can significantly impact their treatment and health outcomes. This study aims to identify the associations between medication beliefs, patient activation, and self-rated health (SRH) among oncology patients taking OAAs and explore the potential mediation effects of patient activation on the relationship between medication beliefs and SRH. METHODS: A secondary data analysis was conducted on cross-sectional data from 114 patients who were diagnosed with breast, colorectal, lung, or prostate cancer. Patients completed a self-reported survey including items of SRH, Beliefs about Medicines Questionnaire (BMQ), and Patient Activation Measure (PAM-13). Descriptive statistics, bivariate correlation, hierarchical multiple linear regression, and mediation analysis were conducted. RESULTS: The results indicate that patients taking OAAs have ambivalent attitudes toward medication. Both medication necessity (r = - 0.27) and concerns (r = - 0.21) were negatively associated with SRH, while patient activation was positively associated with SRH (r = 0.38). Patient activation had a negative association with medication concerns (r = - 0.36) and fully mediated the relationship between medication concerns and SRH in patients taking OAAs (indirect effect = - 0.154, 95% confidence interval, - 0.276 to - 0.060). CONCLUSION: The findings highlight the significance of activating patients to better understand and manage their OAAs. It is crucial for oncology professionals to provide multifaceted interventions to promote patient activation with an effort to mitigate the negative impact of medication beliefs on patient-perceived health outcomes.

Measuring patient activation: the utility of the Patient Activation Measure administered in an interview setting.

BACKGROUND: Patient activation is an emerging field in healthcare research concerning knowledge, skills, and confidence of patients in managing their health. This is particularly important for patients with chronic diseases, who often require more complex care management and self-care skills. However, due to temporary or longer-lasting visual impairments, certain patient groups cannot answer a questionnaire independently. The main objective is to investigate the psychometric properties of the German Patient Activation Measure® (PAM) survey in an everyday clinical setting where it has to be read aloud. METHODS: Outpatients with macular edema participated in this questionnaire-based cross-sectional study. The study assessed patient activation by the PAM® survey, self-rated health, self-efficacy, quality of life, and general mood. Interviewers read questionnaires aloud to patients. Psychometric properties of the PAM® survey were investigated by item response theory (IRT), Cronbach's α and trait-trait correlations. RESULTS: The analysis included N = 554 patients. Median age was 69 (IQR 62.0-76.0) years and mean overall activation score 74.1 (SD 13.7). All items showed ceiling effects. Empirical reliability from the IRT model and Cronbach's α were 0.75. The PAM® survey showed a Spearman correlation of 0.54 with self-efficacy, 0.51 with quality of life and 0.34 with general mood. CONCLUSION: The read-aloud PAM® survey has been shown to provide to adequate measurement precision and convergent validity to be used as a screening tool in an everyday clinical setting. Objective assessment in an interview setting with the PAM® survey is possible. PAM® items are good in distinguishing lower to middle activated patients, but not patients with high activation. Further, issues with structural validity need more investigation.

Patient activation in adults with visual impairment: a study of related factors.

This study aims to analyze variables related to patient activation in 78 individuals with visual impairment. The Patient Activation Measure (PAM) scores of participants showed no differences between males and females. It was found that the individuals living in urban areas, and participants with higher income and education levels had higher PAM scores. Still, the difference between the groups was statistically insignificant (p > 0.05). The PAM scores of the visually impaired individuals reflect taking action level of activation (66.51 ± 18.14-PAM level 3). There was a moderately significant relationship between PAM scores and visually impaired individuals' self-management, self-efficacy, healthy life awareness, social relations, and environment (p < 0.001). We found that the variables included in the regression model (marital status, self-management, self-efficacy, healthy life awareness, social relations, and environment) explained 72.2% of the PAM score. Individuals with visual impairment can be given training on self-management, self-efficacy, healthy life awareness, and quality of life associated with social relations and environment to develop positive health behaviors.

Patient and family engagement in patient safety in the Eastern Mediterranean Region: a scoping review.

BACKGROUND: Patients can play a key role in delivering safe care by becoming actively involved in their health care. This study aimed at reviewing the literature for evidence of patients' and families' engagement in patient safety in the Eastern Mediterranean Region (EMR). METHODS: We conducted a scoping review of the literature published in English using PubMed, Medline, CINAHL, Scopus, ISI Web of Science, and PsycINFO until June 2023. RESULTS: A total of 9019 studies were screened, with 22 meeting the inclusion criteria. Our review found few published studies of patient and family engagement in patient safety research in the EMR. Thirteen studies explored the attitudes, perceptions, and/or experiences / preferences of patients, families, and healthcare providers (HCPs) regarding patient engagement in patient safety. Nine publications reported patient involvement in patient safety activities at varying levels. Three categories of factors were identified that may affect patient involvement: patient-related (e.g., lack of awareness on their role in preventing harms, unwillingness to challenge HCPs' authority, and cultural barriers); HCP-related (e.g., negative attitudes towards patient engagement, poor patient-provider communication, and high workload); and healthcare setting-related (e.g., lack of relevant policies and guidelines, lack of training for patients, and HCPs, and lack of patient-centered approach). CONCLUSION: This review highlighted limitations in the current literature on patient and family engagement in patient safety in the EMR, including both the depth of evidence and clarity of concepts. Further research is needed to explore how to actively involve patients and their families, as well as to determine whether such involvement translates into improved safety in practice.

Patients' experiences of shared decision-making in nursing care: A qualitative study.

AIM: To explore patients' experiences of shared decision-making, in nursing care during their stay in a healthcare institution. DESIGN: This study employed a qualitative descriptive design. METHODS: Twenty participants were interviewed from two rehabilitation centres, a nephrology ward of a hospital, and a rehabilitation ward of a long-term care facility. A constant comparative method was used for the inductive analysis. RESULTS: The main theme was 'feeling seen and understood', in the context of person-centred care, which served as the unifying thread across five themes. The five themes included the importance of a positive nurse-patient relationship as a foundation for shared decision-making. Next, patients experienced collaboration, and this was influenced by verbal and non-verbal communication. Another theme was that patients often felt overwhelmed during their stay, affecting shared decision-making. The fourth theme was that many decisions were not made through the shared decision-making process but were still perceived as satisfactory. The final theme highlighted patients' perspectives on their role in decision-making and influencing factors. CONCLUSION: Patients describe how feeling seen and understood is a prerequisite for shared decision-making as a part of person-centred care. For nurses, this implies that they should focus on aspects such as building a good relationship and acknowledgement of patients' feelings and circumstances, next to empowering patients to feel knowledgeable and valued. This way patient's motivation to participate in shared decision-making will be enhanced. REPORTING METHOD: Following the EQUATOR guidelines, reporting was guided by the Consolidated Criteria for Reporting Qualitative Research (COREQ). PATIENT OR PUBLIC CONTRIBUTION: Patients were involved in the study through interviews during the research process and member checks during analysis. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: Before initiating shared decision-making processes, prioritise making the patient feel seen and understood. Be mindful that patients often feel overwhelmed during their stay. Use a person-centred approach to make patients feel knowledgeable-this empowers them for shared decision-making. IMPACT: Research on patients' experiences of shared decision-making in nursing care is limited, yet crucial for understanding patients' needs in shared decision-making. This study highlights patients' perceptions that shared decision-making is best facilitated within the nurse-patient relationship by nurses who primarily focus on ensuring that patients feel acknowledged and understood.

Correlates of Control Preferences, Participation in Decision-making and Activation in Patients with Substance Use Disorder.

BACKGROUND: Treatment of Substance Use Disorder (SUD) is complex and therefore including patients in the therapeutic process is needed. Patient-Centered Care (PCC) and Shared Decision-Making (SDM) have been associated with greater satisfaction, self-control, and less substance use. However, correlates of SDM have not been investigated in this population. METHOD: A cross-sectional analysis was carried out in 214 SUD patients to identify sociodemographic, clinical and psychological correlates of preferences and perceptions about participation in SDM and degree of activation. The Control Preference Scale (CPS), the Shared Decision-Making Questionnaire (SDM-9-Q) and the Patient Activation Measure (PAM) were used to assess the PCC elements. Multinomial logistic regression was used to analyze the correlates of the CPS variables (preferred role, perceived role, and role matching). For SDM-9-Q and PAM, multilevel linear regression was used. RESULTS: Preferring an active role, compared to a shared one, was significantly associated with higher educational level, lower neuroticism, absence of affective and alcohol use disorders, and higher quality of life. Perceiving greater participation was significantly associated with not being a new patient, having fewer legal problems, higher severity of alcohol consumption, not presenting polydrug use and main substance use different than opioids or sedatives. Activation was associated with higher scores in the personality trait activity, a preference for an active role and greater perception of being involved in the decision process. CONCLUSIONS: Patients with milder clinical profiles prefer an active role compared to a shared one. Patients who prefer or perceive a shared or passive role did not show relevant differences. Greater activation was related to preference for an active role and the perception of having been involved in decisions.

A Virtual Photovoice Study of Older African Americans Perceptions of Neurovascular Clinical Trials.

BACKGROUND: Alzheimer disease (AD) poses a major public health crisis, especially among African Americans (AAs) who are up to 3 times more likely to develop AD compared with non-Hispanic Whites. Moreover, cardiovascular risk factors represent a precursor to cognitive decline, which contributes to racial/ethnic disparities seen within AD. Despite these disparities, AAs are underrepresented in neurovascular research. The purpose of this qualitative virtual photovoice project is to explore how older Midwestern AAs perceive neurovascular clinical trials. METHODS: Five photovoice sessions were held virtually over a 3-month period. Participants took photos each week that captured the salient features of their environment that described their perceptions and experiences related to neurovascular clinical trials. Structured discussion using the SHOWED method was used to generate new understandings about the perspectives and experiences in neurovascular clinical trials. Data was analyzed using strategies in participatory visual research. RESULTS: A total of 10 AAs aged 55 years and older participated and a total of 6 themes emerged from the photovoice group discussions. CONCLUSION: Findings from this study inform the development of culturally appropriate research protocols and effective recruitment strategies to enhance participation among older AAs in neurovascular clinical trials.

Service user involvement in mental health service commissioning, development and delivery: A systematic review of service level outcomes.

INTRODUCTION: Service user involvement is increasingly considered essential in mental health service development and delivery. However, the impact of this involvement on services is not well documented. We aimed to understand how user involvement shapes service commissioning, development and delivery, and if/how this leads to improved service-level outcomes. METHODS: A systematic review of electronic databases (MEDLINE, PsycINFO, CINAHL and EMBASE databases) was undertaken in June and November 2022 for studies that incorporated patient involvement in service development, and reported service-level outcomes. Included studies were synthesised into a logic model based on inputs (method of involvement), activities (changes to service) and outputs (indicators of improvement). PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines were followed when conducting this review. RESULTS: From 10,901 records identified, nine studies were included, of which six were judged to have used co-production or co-design approaches. Included studies described service user involvement ranging from consultation to co-production. We identified a range of outputs associated with service user involvement in service planning and delivery, and reported these in the form of a logic model. These service-level outputs included improved treatment accessibility, increased referrals and greater service user satisfaction. Longer-term outcomes were rarely reported and hence it was difficult to establish whether outputs are sustained. CONCLUSION: More extensive forms of involvement, namely, co-design and co-production, were associated with more positive and substantial outputs in regard to service effectiveness than more limited involvement methods. However, lived experience contributions highlighted service perception outputs may be valued more highly by service users than professionals and therefore should be considered equally important when evaluating service user involvement. Although evidence of longer term outcomes was scarce, meaningful involvement of service users in service planning and delivery appeared to improve the quality of mental health services. PATIENT OR PUBLIC CONTRIBUTION: Members of a lived experience advisory panel contributed to the review findings, which were co-authored by a peer researcher. Review findings were also presented to stakeholders including service users and mental health professionals.

The Patient Activation Measure (PAM) and the pandemic: Predictors of patient activation among Australian health consumers during the COVID-19 pandemic.

BACKGROUND: Preventative healthcare is crucial for improving individual patient outcomes and is integral to sustainable health systems. The effectiveness of prevention programs is enhanced by activated populations who are capable of managing their own health and are proactive to keep themselves well. However, little is known about the level of activation among people drawn from general populations. We used the Patient Activation Measure (PAM) to address this knowledge gap. METHODS: A representative, population-based survey of Australian adults was conducted in October 2021 during the Delta strain outbreak of the COVID-19 pandemic. Comprehensive demographic information was collected, and the participants completed the Kessler-6 psychological distress scale (K6) and PAM. Multinomial and binomial logistic regression analyses were performed to determine the effect of demographic factors on PAM scores, which are categorised into four levels: 1-participants disengaged with their health; 2-becoming aware of how to manage their health; 3-acting on their health; and 4-engaging with preventative healthcare and advocating for themselves. RESULTS: Of 5100 participants, 7.8% scored at PAM level 1; 13.7% level 2, 45.3% level 3, and 33.2% level 4. The mean score was 66.1, corresponding to PAM level 3. More than half of the participants (59.2%) reported having one or more chronic conditions. Respondents aged 18 to 24 years old were twice as likely to score PAM level 1 compared with people aged 25-44 (p < .001) or people aged over 65 years (p < .05). Speaking a language other than English at home was significantly associated with having low PAM (p < .05). Greater psychological distress scores (K6) were significantly predictive of low PAM scores (p < .001). CONCLUSION: Overall, Australian adults showed high levels of patient activation in 2021. People with lower incomes, of younger age, and those experiencing psychological distress were more likely to have low activation. Understanding the level of activation enables targeting sociodemographic groups for extra support to increase the capacity to engage in prevention activities. Conducted during the COVID-19 pandemic, our study provides a baseline for comparison as we move out of the pandemic and associated restrictions and lockdowns. PATIENT OR PUBLIC CONTRIBUTION: The study and survey questions were co-designed with consumer researchers from the Consumers Health Forum of Australia (CHF) as equal partners. Researchers from CHF were involved in the analysis of data and production of all publications using data from the consumer sentiment survey.

Reducing COVID-19 vaccine hesitancy among African Americans: the effects of narratives, character's self-persuasion, and trust in science.

This research examines the efficacy of self-persuasion narratives (i.e., narratives that describe how a character has changed their mind about the COVID-19 vaccines) in encouraging vaccine uptake among unvaccinated African Americans. A five-condition experiment (N = 394) was conducted in June 2021. Participants viewed one of the three pro-vaccine messages (a self-persuasion narrative, a narrative without self-persuasion, or a non-narrative message) or an irrelevant message or completed a self-persuasion task. Findings supported the persuasive benefits of the self-persuasion narrative compared to the narrative without self-persuasion, actual self-persuasion, and the irrelevant message. Its advantage over the narrative without self-persuasion was mediated by increased self-referencing, affective empathy, and perceived similarity with the character. Moreover, its psychological effects were moderated by participants' trust in science. Unexpectedly, the non-narrative showed persuasive benefits compared to other intervention strategies. The theoretical implications for narrative persuasion and practical implications for vaccine promotion were discussed.

Perceptions of Caring Recruitment Among Older Adults: African Americans and Non-Latinx Whites.

BACKGROUND: African Americans (AAs) are underrepresented in health-related research studies. Few studies have investigated how behaviors of study recruiters affect recruitment of older AAs versus non-Latinx Whites (NLWs). OBJECTIVES: The aim of this study was to explore whether caring behaviors influence AA and NLW older adults' decision to participate in hypothetical, high-commitment, health-related research studies and differences in participants' enrollment decisions by race. METHODS: Using a descriptive, cross-sectional study design, guided by Kristen Swanson's middle-range theory of caring, a research-savvy sample of 60 AA and 60 NLW adults (age > 65 years) were randomly assigned one of two written vignettes. The concept of caring behaviors was manipulated and illustrated in a hypothetical recruitment scenario. A participant feedback survey was used to assess (a) participants' perceptions of caring and uncaring behaviors exhibited by the fictitious research recruiter, (b) differences in their willingness to participate based on vignette type, and (c) participants' judgment of the research recruiter as being caring or uncaring. A chi-square test assessed the association among categorical variables (caring behavior and participants' race). RESULTS: Participants who received the vignette with the high caring recruiter were more than twice as likely to agree to participate in the study than those who received the vignette with the low caring recruiter. AA and NLW participants did not differ in their likelihood to agree to participate. Participants who received the caring vignette and judged the recruiter as caring were 5 times as likely to agree to participate in the high-commitment study than those who received the uncaring vignette ( p < .001). Associations did not vary by race. DISCUSSION: This experimental study of equally recruited older adults from an existing longitudinal study revealed that caring behaviors in recruitment strategies are associated with an increased likelihood of participation in high-commitment research with older adults. The research-savvy AA participants were just as likely to participate in the hypothetical high-commitment research as their NLW peers when the fictional research recruiter was perceived as having caring behaviors. When targeting specific populations, it is essential to employ nuanced recruitment approaches where the study recruiters are attuned to caring behaviors.

Management reasoning and patient-clinician interactions: Insights from shared decision-making and simulated outpatient encounters.

PURPOSE: To expand understanding of patient-clinician interactions in management reasoning. METHODS: We reviewed 10 videos of simulated patient-clinician encounters to identify instances of problematic and successful communication, then reviewed the videos again through the lens of two models of shared decision-making (SDM): an 'involvement-focused' model and a 'problem-focused' model. Using constant comparative qualitative analysis we explored the connections between these patient-clinician interactions and management reasoning. RESULTS: Problems in patient-clinician interactions included failures to: encourage patient autonomy; invite the patient's involvement in decision-making; convey the health impact of the problem; explore and address concerns and questions; explore the context of decision-making (including patient preferences); meet the patient where they are; integrate situational preferences and priorities; offer >1 viable option; work with the patient to solve a problem of mutual concern; explicitly agree to a final care plan; and build the patient-clinician relationship. Clinicians' 'management scripts' varied along a continuum of prioritizing clinician vs patient needs. Patients also have their own cognitive scripts that guide their interactions with clinicians. The involvement-focused and problem-focused SDM models illuminated distinct, complementary issues. CONCLUSIONS: Management reasoning is a deliberative interaction occurring in the space between individuals. Juxtaposing management reasoning alongside SDM generated numerous insights.