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Giving Voice to Clinical Study Participants: Development and Deployment of Sequential Patient Experience Surveys for Global Clinical Studies.

ABSTRACT: BACKGROUND:Biopharmaceutical companies are piloting patient experience surveys (PES) to help enhance patient satisfaction with clinical studies. However, most PES have been conducted at study close-out, which can hinder recall and responsiveness, and at a limited number of sites, which restricts their applicability to global studies. Our aim was to investigate the feasibility of developing sequential PES, which would be deployed globally, and to provide practical recommendations based on our real-world experience. METHODS:To develop sequential PES (introductory, interim, close-out), we customized a previously developed patient experience close-out survey. Extensive input was gained from multiple stakeholders (e.g., survey experts, patient advisors, psychometricians, clinical trialists, lawyers). To deploy the PES in global studies, we prepared PES-specific ethics committee submissions, training materials (e.g., slides, videos), and PES invitation aids (postcards, digital app reminders). RESULTS:Developing and deploying sequential PES in global clinical studies was feasible. The 3-part online PES (25 to 37 questions per survey) passed health literacy testing. To facilitate benchmarking, the PES included core questions (including a Net Promoter Score question). The PES gained ethics approval and was deployed globally in 2017-2018 in 12 phase 2 and 3 clinical studies in North America, Europe, and the Asia-Pacific. Based on the real-world insights gained and the challenges encountered, we have made recommendations for PES. CONCLUSIONS:Our practical recommendations on the development and deployment of sequential global PES may assist others to implement PES efficiently and effectively, allowing them to gain feedback from patients globally during clinical studies.

SUBMITTER: Manning E

PROVIDER: S-EPMC7458896 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Giving Voice to Clinical Study Participants: Development and Deployment of Sequential Patient Experience Surveys for Global Clinical Studies.

Manning Elizabeth E Herndon Mitch M Frye Wendy W Ice Tammy S TS Thyssen Nadia N Pushparajah Daphnee S DS Yates Stephen L SL

Therapeutic innovation & regulatory science 20200121 5

<h4>Background</h4>Biopharmaceutical companies are piloting patient experience surveys (PES) to help enhance patient satisfaction with clinical studies. However, most PES have been conducted at study close-out, which can hinder recall and responsiveness, and at a limited number of sites, which restricts their applicability to global studies. Our aim was to investigate the feasibility of developing sequential PES, which would be deployed globally, and to provide practical recommendations based on ...[more]

PMID: 31965539

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Project description:Ethical controversy surrounds clinical research involving seriously ill participants. While many stakeholders have opinions, the extent to which protocol volunteers themselves see human research as ethically acceptable has not been documented. To address this gap of knowledge, authors sought to assess views of healthy and ill clinical research volunteers regarding the ethical acceptability of human studies involving individuals who are ill or are potentially vulnerable.Surveys and semi-structured interviews were used to query clinical research protocol participants and a comparison group of healthy individuals. A total of 179 respondents participated in this study: 150 in protocols (60 mentally ill, 43 physically ill, and 47 healthy clinical research protocol participants) and 29 healthy individuals not enrolled in protocols. Main outcome measures included responses regarding ethical acceptability of clinical research when it presents significant burdens and risks, involves people with serious mental and physical illness, or enrolls people with other potential vulnerabilities in the research situation.Respondents expressed decreasing levels of acceptance of participation in research that posed burdens of increasing severity. Participation in protocols with possibly life-threatening consequences was perceived as least acceptable (mean = 1.82, sd = 1.29). Research on serious illnesses, including HIV, cancer, schizophrenia, depression, and post-traumatic stress disorder, was seen as ethically acceptable across respondent groups (range of means = [4.0, 4.7]). Mentally ill volunteers expressed levels of ethical acceptability for physical illness research and mental illness research as acceptable and similar, while physically ill volunteers expressed greater ethical acceptability for physical illness research than for mental illness research. Mentally ill, physically ill, and healthy participants expressed neutral to favorable perspectives regarding the ethical acceptability of clinical research participation by potentially vulnerable subpopulations (difference in acceptability perceived by mentally ill - healthy = -0.04, CI [-0.46, 0.39]; physically ill - healthy = -0.13, CI [-0.62, -.36]).Clinical research volunteers and healthy clinical research-"naïve" individuals view studies involving ill people as ethically acceptable, and their responses reflect concern regarding research that poses considerable burdens and risks and research involving vulnerable subpopulations. Physically ill research volunteers may be more willing to see burdensome and risky research as acceptable. Mentally ill research volunteers and healthy individuals expressed similar perspectives in this study, helping to dispel a misconception that those with mental illness should be presumed to hold disparate views.

Project description:Background:Efforts to engage patients as partners in health research have grown and thereby the need for feedback and evaluation. In this pilot evaluation study, we aimed to 1) evaluate patient engagement in health research projects in Newfoundland and Labrador, Canada, and 2) learn more about how to best monitor and evaluate patient engagement. This paper presents the results of our participatory evaluation study and the lessons learned. The evaluation of the projects was driven by questions patients wanted answered. Methods:We conducted a formative evaluation of patient engagement in health research projects. Projects spanned a variety of topics, target groups, research designs and methods of patient engagement. Participants included principal investigators (n =?6) and their patient partners (n =?14). Furthermore, graduate students (n =?13) working on their own research projects participated. Participants completed an online survey with closed and open-ended questions about their patient engagement efforts, experiences and preliminary outcomes. Patients were involved as co-investigators in the entire evaluation study. We used qualitative methods to evaluate our participatory process. Results:The evaluation study results show that most patients and researchers felt prepared and worked together in various phases of the research process. Both groups felt that the insights and comments of patients influenced research decisions. They believed that patient engagement improved the quality and uptake of research. Students felt less prepared and were less satisfied with their patient engagement experience compared to researchers and their patient partners. Involvement of patient co-investigators in this evaluation resulted in learnings, transparency, validation of findings and increased applicability. Challenges were to select evaluation questions relevant to all stakeholders and to adapt evaluation tools to local needs. Conclusions:Our findings show that researchers, patient partners and students value patient engagement in health research. Capacity building at the supervisor level in academic institutions is needed to better support students. Sufficient time is also needed to permit observable outcomes. Participatory evaluation may increase the relevance and usefulness of information, but it also raises issues such as who defines and designs the content of evaluation tools. A co-creation process is required to develop appropriate monitoring and evaluation strategies.

Project description:ImportancePrecision oncology is revolutionizing cancer care, allowing for personalized treatments to improve outcomes. Cancer research has benefitted from well-designed studies incorporating precision medicine objectives, but it is unclear if these studies are representative of the diverse cancer population.ObjectiveTo evaluate racial and ethnic representation in breast, prostate, lung, and colorectal cancer studies incorporating precision oncology objectives in the Clinicaltrials.gov registry and compare with the incidence of these cancer types in racial and ethnic minority groups in the US population.Design, setting, and participantsThis cross-sectional study identified US-based breast, prostate, lung, and colorectal cancer studies incorporating precision oncology objectives for reporting of race and ethnicity. The Surveillance, Epidemiology, and End Results and US Census databases were used to determine cancer incidence by race and ethnicity, linked with cancer type and median year of enrollment for each trial. Data were collected and analyzed between December 2020 and April 2021.Main outcomes and measuresThe expected number of participants per study by each racial and ethnic group was calculated based on the corresponding US-based proportion. Under- and overrepresentation was defined as the ratio of the actual number of enrolled cases to the expected number of cases for each trial by cancer type. Ratios above 1 indicated overrepresentation while a ratio below 1 indicated underrepresentation. Random-effects meta-analysis of representation ratios of individual trials was performed to weigh each individual study.ResultsOf 93 studies encompassing 5867 enrollees with race and ethnicity data; 4826 participants (82.3%) were non-Hispanic White, 587 (10.0%) were Black, and 238 (4.1%) were Asian. Per observed-to-expected ratios, White participants were overrepresented in all studies, with a ratio of 1.35 (95% CI, 1.30-1.37), as well as Asian participants, with a ratio of 1.46 (95% CI, 1.28-1.66), while Black participants (ratio, 0.49; 95% CI, 0.45-0.54), Hispanic participants (ratio, 0.24; 95% CI, 0.20-0.28), and American Indian and Alaskan Native participants (ratio, 0.43; 95% CI, 0.24-0.78) were underrepresented. By individual cancer site, White participants were consistently overrepresented in all studies, while Black and Hispanic participants were underrepresented.Conclusions and relevanceThis analysis found that precision oncology studies for breast, lung, prostate, and colorectal cancers vastly underrepresent racial and ethnic minority populations relative to their cancer incidence in the US population. It is imperative to increase diversity among enrollees so that all individuals may benefit from cancer research breakthroughs and personalized treatments.

Project description:Background: While there is an increasing consensus that clinical trial results should be shared with trial participants, there is a lack of evidence on the most appropriate methods. The aim of this study is to use a patient and public involvement (PPI) approach to identify, develop and evaluate a patient-preferred method of receiving results of the Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial (TRUST). Methods: This is a mixed methods study with three consecutive phases. Phase 1 iteratively developed a patient-preferred result method using semi-structured focus groups and a consensus-orientated-decision model, a PPI group to refine the method and adult literacy review for plain English assessment. Phase 2 was a single-blind parallel group trial. Irish TRUST participants were randomised to the intervention (patient-preferred method) and control group (standard method developed by lead study site). Phase 3 used a patient understanding questionnaire to compare patient understanding of results between the two methods. Results: Patients want to receive results of clinical trials, with qualitative findings indicating three key themes including 'acknowledgement of individual contribution', 'contributing for a collective benefit' and 'receiving accessible and easy to understand results'. Building on these findings, a patient-preferred method of receiving results was developed as described above. TRUST participants (n=101) were randomised to the intervention. The questionnaire response rate was 74% for the intervention group and 62% for the control group. There were no differences in patient understanding between the two methods. Conclusions: We have demonstrated that it is feasible to conduct PPI with regard to the dissemination of results. The study identified and developed a patient-preferred method of receiving clinical trial results for older adults over 65 years. Although, in this study PPI did not influence patients' final understanding of results, it provides a record of the process of conducting PPI within the clinical trial setting.

Project description:BackgroundRecently WHO researchers described seven dimensions of mistreatment in maternity care that have adverse impacts on quality and safety. Applying the WHO framework for quality care, service users partnered with NGOs, clinicians, and researchers, to design and conduct the Giving Voice to Mothers (GVtM)-US study.MethodsOur multi-stakeholder team distributed an online cross-sectional survey to capture lived experiences of maternity care in diverse populations. Patient-designed items included indicators of verbal and physical abuse, autonomy, discrimination, failure to meet professional standards of care, poor rapport with providers, and poor conditions in the health system. We quantified the prevalence of mistreatment by race, socio-demographics, mode of birth, place of birth, and context of care, and describe the intersectional relationships between these variables.ResultsOf eligible participants (n = 2700), 2138 completed all sections of the survey. One in six women (17.3%) reported experiencing one or more types of mistreatment such as: loss of autonomy; being shouted at, scolded, or threatened; and being ignored, refused, or receiving no response to requests for help. Context of care (e.g. mode of birth; transfer; difference of opinion) correlated with increased reports of mistreatment. Experiences of mistreatment differed significantly by place of birth: 5.1% of women who gave birth at home versus 28.1% of women who gave birth at the hospital. Factors associated with a lower likelihood of mistreatment included having a vaginal birth, a community birth, a midwife, and being white, multiparous, and older than 30 years. Rates of mistreatment for women of colour were consistently higher even when examining interactions between race and other maternal characteristics. For example, 27.2% of women of colour with low SES reported any mistreatment versus 18.7% of white women with low SES. Regardless of maternal race, having a partner who was Black also increased reported mistreatment.ConclusionThis is the first study to use indicators developed by service users to describe mistreatment in childbirth in the US. Our findings suggest that mistreatment is experienced more frequently by women of colour, when birth occurs in hospitals, and among those with social, economic or health challenges. Mistreatment is exacerbated by unexpected obstetric interventions, and by patient-provider disagreements.

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Giving Voice to Clinical Study Participants: Development and Deployment of Sequential Patient Experience Surveys for Global Clinical Studies.

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Giving Voice to Clinical Study Participants: Development and Deployment of Sequential Patient Experience Surveys for Global Clinical Studies.

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