Members of many racial and ethnic population subgroups are underrepresented in clinical trials and research. We present perspectives on barriers and facilitators to study participation gathered from Hispanic participants in a population-based genetic screening study.

Seven focus groups (five in English and two in Spanish) were conducted with self-identified Hispanic participants of the Healthy Oregon Project (HOP), a large population-based cohort of adults residing in Oregon. HOP study participants complete surveys about cancer and chronic disease risks with the option to donate a saliva sample for no-cost genetic risk screening for inherited disorders. HOP invited Hispanic participants via email to join a focus group about their experiences. Focus groups, generally lasting 60–90 minutes, occurred in person and virtually. Notes were coded and content-analyzed.

49 Hispanic adults participated in the focus groups (37 women; 9 men; 3 non-binary people). Identified facilitators for HOP study participation were trust in the academic medical center leading the study, having a family member who was impacted by cancer, and receiving free genetic screening. Identified barriers were difficulty completing the family history survey, lack of understanding or familiarity with research, immigration status, and navigating technology challenges. Recommendations to improve recruitment of Hispanic populations included promoting the study at community events, clinics, or schools, simplifying the consenting process and providing patient-focused videos to demonstrate study tasks, providing real-time sample tracking, and offering monetary incentives.

Our findings can inform strategies for bolstering recruitment of Hispanic adults in biomedical research studies.

The study, conducted by the French National Authority for Health (HAS), aimed to identify available online health technology assessment (HTA) training tools for patients, specifically those used by HTA bodies (HTAbs) and major selected European and international patient and consumer groups (PCGs), to inform an HTA training approach for HAS.

A literature search, a review of selected websites, semi-structured interviews with HTAbs and patient groups, and discussion within a dedicated working group to help target the needs and preferences of patients and consumers were conducted. Online HTA training tools relating to HTA and patient and public involvement (PPI), published or translated into English or French, were included in the study results.

Eighty-two online HTA training tools for patients and consumers were selected according to the specified inclusion criteria coming from sixteen international HTAbs, nine European and international PCGs, and thirteen other organizations. Two main categories emerged: the first relating to HTA and the second relating to PPI in HTA. The formats of these tools ranged from interactive and non-interactive formats with varying accessibility and assessment methods. No journal articles mentioned explicitly the content and format of PCG training tools.

This research served as a basis for HAS to develop their own HTA training tools and materials for patients and consumers. Two training tools were subsequently developed, guided by the needs and preferences of a patient and consumer working group, and were published on the HAS website in November 2022.

In current clinical practices, there exist very few methods that allow patients to be truly engaged in violence risk assessment and management. This may hinder an individual’s experience of basic psychological needs; autonomy, competence, and relatedness.

To describe patients’ ideas on how they would develop current violence risk assessment and management practices.

The data collection took place as part of a larger project in one PICU unit specialized in the treatment of patients with psychosis and violent behavior in Finland. Individual interviews were conducted with patients (n=13) and were guided to focus on the development of violence risk assessment and management. The data were analyzed using inductive content analysis.

Patients’ ideas focused on themes related to developing patient engagement and violence risk management methods. Developing patient engagement involved noticing patient’s individuality and collaboration between a patient and staff: for instance, by shared risk assessment and individualized risk management. Developing violence risk management methods included themes about providing alternative risk management methods and developing nursing staff’s work. Suggestions were, for example, related to providing ways how to calm down, having meaningful activities during treatment days, and ensuring the realization of patient’s rights.

Patients having treatment in the PICU unit have clear and concrete ideas on how violence risk assessment and management methods could be developed further. These findings indicate, that patients need to be given a more active role in their care and thus ensure that basic psychological needs are promoted. Funding by Academy of Finland (316206 ) and TYKS foundation.

No significant relationships.

Conquering CHD, formerly known as the Pediatric Congenital Heart Association (PCHA), is the leading congenital heart disease (CHD) patient advocacy organisation in the United States of America, and places high priority on patient engagement in the research process. Participatory design is an approach to problem-solving that utilises the knowledge and opinions of groups of people to generate plans and new ideas. Utilising this mode of patient engagement, patients and families engaged with Conquering CHD assisted in developing a list of research priorities which was then distributed to the larger membership with instructions to rank the priorities in order of importance. Upon completion, these items were compared to the current scientific literature to assess correlation with current publications. This cross-sectional study and literature review aimed to assess the priorities of patients and families in CHD research and to determine the reflection of these areas in the current body of scientific literature.

This cross-sectional study utilised a survey asking participants to rank the importance of research items within categories including “Technology Advances,” “Genetic and Cellular Research,” “Broad Understanding of CHD,” and “Psychosocial Outcomes” which was distributed through social media and email to 43,168 accounts across all platforms. Respondents were asked to place each item in a ranked order in each category, with the value “1” representing the most preferred for each participant. Anyone engaged with Conquering CHD was eligible to complete the study, including patients and families. Subsequently, a literature review of the largest medical databases including PubMed, Scopus, and ScienceDirect was undertaken to determine the number of articles published per each topic which was then assessed to determine if there is a correlation between patient-ranked priorities and the current body of literature.

The study generated a total response of 527 participants. Regarding “Technology Advances,” valve replacement was the preferred topic (mean rank 2.07, IQR 2). Stem cell research was the favoured topic in “Genetic and Cellular Research” (mean rank 2.53, IQR 2). Access to care was the priority in the “Broadening Understanding of CHD” (mean rank 1.24, IQR 1). Pertaining to “Psychosocial Outcomes”, psychological/emotional effects was the highest ranked topic (mean rank 1.46, IQR 1). The literature review returned a total of 135,672 articles in the areas of interest. For “Valve Replacement”, 8361 articles resulted reflecting a proportion of 0.097 of total articles. For “Stem Cell Research”, 9921 articles resulted reflecting a proportion of 0.115 of total articles. For “Access to Care”, 7845 articles resulted reflecting a proportion of 0.091 of total articles. For “Psychological/Emotional Effects”, 6422 articles resulted reflecting a proportion of 0.074 of total articles. A Spearman’s correlation demonstrated no correlation between the preferred domain of CHD research and the number of articles published for that domain (rs = 0.02, p = 0.94).

This process demonstrates the effectiveness of participatory design, using a patient and family network to determine the research items of concern to those affected by CHD. The cross-sectional survey was effective in assessing patient and family priorities but was limited by access to reliable internet and delivery only in English. Though the study had a large response rate, it was limited to patients already engaged with Conquering CHD. For these reasons, it may not completely reflect the opinions of the total population affected by CHD. However, this offers valuable insight into patient-determined priorities and reveals that the current scientific literature does not correlate with these items. These data serve to inform individual and institutional research agendas to better reflect the needs and desires of this population.

Motivation deficit is a significant aspect of lack of improvement in patients with schizophrenia especially with predominant negative symptoms (PNS). Therefore, improvement depends not only on symptoms reduction and better social functioning but also on patient engagement which is a key but less investigated aspect of successful treatment.

To investigate and compare patient engagement in PNS patients after cariprazine and risperidone treatment characterized by the 11 items of the Positive and Negative Syndrome Scale (PANSS-11).

In this phase 3 study patients suffering from PNS of schizophrenia (PANSS-FSNS≥24) were randomized to 26 weeks of treatment with either cariprazine or risperidone (target dose 4.5 and 4 mg/day, respectively). To compare the effects of the two drugs on patient engagement the PANSS-11 scale was used. Change from baseline (CfB) on the selected items and PANSS-11 total score were analyzed using mixed model of repeated measures approach without correction for multiplicity.

PANSS-11 total score mean CfB were -11.20 (SD=0.43) for cariprazine-, and -9.44 (SD=0.45) for risperidone-treated patients with a -1.79 (95% CI=-3.01, -0.56) mean difference (p=0.004) in favor of cariprazine. Most item differences were statistically significant (N1, N2, N3, N4, N5, G16) or numerically higher (N6, G7, G13) for cariprazine versus risperidone.

Cariprazine significantly improved patient engagement in patients with PNS of schizophrenia compared to risperidone based on the PANSS-11 post-hoc analysis. These results suggest that cariprazine treatment may improve not only the symptoms and everyday functioning of PNS patients but their engagement with life.

Studies were funded by Gedeon Richter Plc. and Allergan Plc (prior to its acquisition by AbbVie). Dr. Laszlovszky, Dombi, Balogh, Dr Barabassy, Dr Vass, Dr. Szatmári and Dr. Németh are employees of Gedeon Richter Plc.

Research Electronic Data Capture (REDCap) is a secure, web-based electronic data capture application for building and managing surveys and databases. It can also be used for study management, data transfer, and data export into a variety of statistical programs. REDcap was developed and supported by the National Center for Advancing Translational Sciences Program and is used in over 3700 institutions worldwide. It can also be used to track and measure stakeholder engagement, an integral element of research funded by the Patient-Centered Outcomes Research Institute (PCORI). Continuously and accurately tracking and reporting on stakeholder engagement activities throughout the life of a PCORI-funded trial can be challenging, particularly in complex trials with multiple types of engagement.

In this paper, we show our approach for collecting and capturing stakeholder engagement activities using a shareable REDCap tool in one of the PCORI’s first large pragmatic clinical trials (the Comprehensive Post-Acute Stroke Services) to inform other investigators planning cluster-randomized pragmatic trials. Benefits and challenges are highlighted for researchers seeking to consistently monitor and measure stakeholder engagement.

We describe how REDCap can provide a time-saving approach to capturing how stakeholders engage in a PCORI-funded study and reporting how stakeholders influenced the study in progress reports back to PCORI.