Patient-Centered Research Research Articles

Priorities for Patient-Centered Research in Valvular Heart Disease: A Report From the National Heart, Lung, and Blood Institute Working Group.

Over the past decade, the field of valvular heart disease (VHD) has rapidly transformed, largely as a result of the development and improvement of less invasive transcatheter approaches to valve repair or replacement. This transformation has been supported by numerous well‐designed randomized trials, but they have centered almost entirely on devices and procedures. Outside this scope of focus, however, myriad aspects of therapy and management for patients with VHD have either no guidelines or recommendations based only on expert opinion and observational studies. Further, research in VHD has often failed to engage patients to inform study design and identify research questions of greatest importance and relevance from a patient perspective. Accordingly, the National Heart, Lung, and Blood Institute convened a Working Group on Patient‐Centered Research in Valvular Heart Disease, composed of clinician and research experts and patient advocacy experts to identify gaps and barriers to research in VHD and identify research priorities. While recognizing that important research remains to be done to test the safety and efficacy of devices and procedures to treat VHD, we intentionally focused less attention on these areas of research as they are more commonly pursued and supported by industry. Herein, we present the patient‐centered research gaps, barriers, and priorities in VHD and organized our report according to the “patient journey,” including access to care, screening and diagnosis, preprocedure therapy and management, decision making when a procedure is contemplated (clinician and patient perspectives), and postprocedure therapy and management. It is hoped that this report will foster collaboration among diverse stakeholders and highlight for funding bodies the pressing patient‐centered research gaps, opportunities, and priorities in VHD in order to produce impactful patient‐centered research that will inform and improve patient‐centered policy and care.

Abstracts From the 26th Annual Health Care Systems Research Network Conference, April 8–10, 2020

The Health Care Systems Research Network (HCSRN) is made up of community-based care delivery systems with a shared mission to improve health and health care through research. The network’s annual conference serves as a forum for attendees to disseminate study findings, stimulate collaborations, and share insights about conducting research in real-world care settings. Although this year’s live conference was cancelled to help slow the spread of COVID-19, the oral and poster abstracts accepted for presentation at HCSRN 2020 are published in this open access supplement to Volume 7, Issue 1 of the Journal of Patient-Centered Research and Reviews, the official scientific journal of the conference.

MP71-01 A TALE OF TWO SURGERIES: A NOVEL FAMILY DESIGNED RECRUITMENT STRATEGY FOR A BLINDED, RANDOMIZED SURGICAL TRIAL IN CHILDREN

You have accessJournal of UrologyPediatrics: Upper Urinary Tract Disorders and Fetal Urology (MP71)1 Apr 2020MP71-01 A TALE OF TWO SURGERIES: A NOVEL FAMILY DESIGNED RECRUITMENT STRATEGY FOR A BLINDED, RANDOMIZED SURGICAL TRIAL IN CHILDREN William Bennett, Konrad Szymanski, Mark Cain, Rosalie Misseri, and Benjamin Whittam* William BennettWilliam Bennett More articles by this author , Konrad SzymanskiKonrad Szymanski More articles by this author , Mark CainMark Cain More articles by this author , Rosalie MisseriRosalie Misseri More articles by this author , and Benjamin Whittam*Benjamin Whittam* More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000951.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: There are few randomized controlled trial (RCTs) comparing techniques in pediatric surgery. We propose the use of novel patient-centered research methods to develop a recruitment approach acceptable to pediatric patients and their families and to evaluate enrollment using this approach to conduct a pilot trial comparing open pyeloplasty (OP) vs. robotic-assisted pyeloplasty (RAP). METHODS: We performed a single-center qualitative study utilizing patient engagement methods to create a recruitment tool for a blinded, randomized controlled trial of two different surgical techniques. We enrolled a total of 28 parents to participate in three sessions focused on factors influencing the decision between RAP and OP, in order to identify barriers to randomization and blinding using established human-centered design techniques to generate multimedia tools (video and handouts) for use in recruitment. Patients planning OP or RAP as well as those who already had the procedure were recruited. RESULTS: From the initial sessions of parents of children who had either OP or RAP we discovered that the concept of two operations being interchangeable was difficult for participants to grasp. We learned to refer to them, not as two “operations”, but as two “surgical approaches”. With this knowledge, we developed two videos to introduce parents of children with ureteropelvic junction obstruction (UPJO) to the concept of clinical equipoise between the two corrective surgical approaches their child could undergo. A subsequent session with parents of children ages 2-8 years and no history of surgery or UPJO watched the two videos, discussed their choice for either approach and whether the videos altered that choice. We learned that the videos improved the parents’ understanding that two surgical approaches could be interchangeable. Using input from this last session, a final video was created to be used for a pilot prospective, blinded randomized controlled trial of RAP versus OP. To date, this video has been used with a successful enrollment rate of 92% (11 of 12 families approached over 16 months). CONCLUSIONS: Using generative qualitative human-centered design sessions, we found that the concept of clinical equipoise of two surgical approaches is a difficult concept to grasp for parents. Using concepts gleaned from this approach, we created a video focused on explaining this concept. Use of this video has resulted in over 90% patient enrollment in an ongoing randomized, blinded pilot study comparing two surgical approaches in children. Source of Funding: NIH: 1R21DK108134-01 © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e1064-e1064 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information William Bennett More articles by this author Konrad Szymanski More articles by this author Mark Cain More articles by this author Rosalie Misseri More articles by this author Benjamin Whittam* More articles by this author Expand All Advertisement PDF downloadLoading ...

Centring sexual and reproductive health and justice in the global COVID-19 response

Centring sexual and reproductive health and justice in the global COVID-19 response

Rationale and Design of the Aspirin Dosing—A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) Trial

Determining the right dosage of aspirin for the secondary prevention treatment of atherosclerotic cardiovascular disease (ASCVD) remains an unanswered and critical question. To report the rationale and design for a randomized clinical trial to determine the optimal dosage of aspirin to be used for secondary prevention of ASCVD, using an innovative research method. This pragmatic, open-label, patient-centered, randomized clinical trial is being conducted in 15 000 patients within the National Patient-Centered Clinical Research Network (PCORnet), a distributed research network of partners including clinical research networks, health plan research networks, and patient-powered research networks across the United States. Patients with established ASCVD treated in routine clinical practice within the network are eligible. Patient recruitment began in April 2016. Enrollment was completed in June 2019. Final follow-up is expected to be completed by June 2020. Participants are randomized on a web platform in a 1:1 fashion to either 81 mg or 325 mg of aspirin daily. The primary efficacy end point is the composite of all-cause mortality, hospitalization for nonfatal myocardial infarction, or hospitalization for a nonfatal stroke. The primary safety end point is hospitalization for major bleeding associated with a blood-product transfusion. End points are captured through regular queries of the health systems' common data model within the structure of PCORnet's distributed data environment. As a pragmatic study and the first interventional trial conducted within the PCORnet electronic data infrastructure, this trial is testing several unique and innovative operational approaches that have the potential to disrupt and transform the conduct of future patient-centered randomized clinical trials by evaluating treatments integrated in clinical practice while at the same time determining the optimal dosage of aspirin for secondary prevention of ASCVD. ClinicalTrials.gov Identifier: NCT02697916.

Abstract 56: Blood Pressure Control in the Real World - Early Evidence From a National Blood Pressure Surveillance System

Background: The Patient-Centered Outcomes Research Institute (PCORI) funded National Blood Pressure Surveillance System (BP Track) is a new national system that generates quarterly metrics of blood pressure (BP) control and BP-related quality metrics for participating healthcare systems from electronic health record (EHR) data. Methods: Queries against standardized EHR data in the national Patient-Centered Clinical Research Network (PCORnet) Common Data Model format produce a set of quality metrics relevant to improving BP control, including Controlling High BP (NQF 0018) and Improvement in BP (CMS65v7), and eight process measures specific to clinical management and treatment practices for improving BP control ( Table ). The metrics, aggregated overall and by health system are reported back to health systems via user-friendly Tableau dashboards, and allow for observation of metric trends. Results: To date, 19 datamarts have contributed EHR data from 1,177,232 patients who met the eligibility criteria for the BP Control measure and 4,454,729 encounters that included a BP measurement during the measurement period. Average age was 62 years; 10% were young adults (<45 years), 17% were African American, 52% female, 28% had diabetes, 15% had coronary heart disease, and 14% had depression. Results demonstrate substantial opportunity for improvement in overall BP control (60% with BP<140/<90 mmHg, range: 42-72%), and many healthcare processes, including medication intensification (12%, 0.6-22%) and use of fixed dose combination medications (24%, 0-88%, Table ). Conclusion: Major opportunities exist for improving BP control, especially in improving the frequency and quality of BP medication prescribing for patients with high BP. The BP Track National BP Surveillance System will track these metrics, by demographic subgroup and over time, and will generate data that can guide and focus quality improvement initiatives aimed at effective BP management.

Health-related quality of life in renal stone formers: are we improving?

Health-related quality of life (HRQOL) is a multidimensional construct measuring how disease impacts one's life. In the context of nephrolithiasis this is particularly relevant given the active and quiescent phases of the disease which may not correlate with the traditional index of stone free status. Several instruments are now available to objectively measure HRQOL in this population, including the first disease-specific instrument. Therefore, an overview of emerging data on HRQOL is provided that reviews the availability of these tools/instruments and emphasizes patient-centered care and research. The common generic instruments used to measure HRQOL in any population (36-Item Short Form health survey and Patient-Reported Outcomes Measurement Information System) and the only disease-specific instrument developed to measure HRQOL in nephrolithiasis (Wisconsin Stone Quality of Life Questionnaire) are described. Emerging evidence suggests that age and sex influence renal stone formers perception of their HRQOL across a range of dimensions. Several other factors also appear to play a role, such as socioeconomic status, but these have yet to be validated in more than one study or population, and postoperative outcomes measured in terms of HRQOL are almost absent from the literature. Physician-centric outcomes, such as stone status, are no longer the only objective and acceptable measures by which to understand the natural history of nephrolithiasis. Patient-centered approaches through the use of HRQOL are slowly emerging in research and clinical care alike. However, they remain largely in their infancy in these spheres.

Setting a research agenda for vascular Ehlers-Danlos syndrome using a patient and stakeholder engagement model

ObjectiveVascular Ehlers-Danlos syndrome (vEDS) is a rare, syndromic, heritable condition with life-threatening complications that include aortic and arterial aneurysms, dissection, and rupture. This study describes the formation of the vEDS Research Collaborative and methods used for stakeholder engagement. MethodsThe vEDS Research Collaborative was established with an engagement award from the Patient-Centered Outcomes Research Institute to create a framework for a patient-researcher partnership. Between October 1, 2017, and September 30, 2018, the Collaborative used the Patient-Centered Outcomes Research Institute Engagement Rubric to conduct stakeholder engagement to develop a patient-centered research agenda. A modified Delphi technique was used to develop and to refine research topics and questions, gathering input from all stakeholders during three rounds of feedback. ResultsFour topic areas were deemed important: mental health and quality of life issues, creating a care team, a holistic approach to vEDS management (medical and surgical), and pregnancy management. An online survey to rank a list of 12 research questions in these topic areas in order of importance was disseminated. The questions were ranked in order of importance through an online survey (N = 197 responses). The survey showed a high degree of alignment in the top priorities among stakeholders. There was a high degree of interest in pragmatic clinical trials evaluating medical management options and health-related quality of life outcomes. ConclusionsThe vEDS Research Collaborative has built a sustainable, coalition model of patient and stakeholder engagement, supported by the vEDS community, to identify a patient-centered, prioritized list of research questions. In articulating a shared vision for the future of vEDS research, the Collaborative has laid the groundwork for developing research protocols aligned with the highest priority questions for the individuals affected by this serious condition that can be translated into future clinical trials.

Role of health plan administrative claims data in participant recruitment for pragmatic clinical trials: An Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) example.

The purpose of this study is to evaluate HealthCore/Anthem Research Network recruitment strategies, compare response and enrollment rates for different recruitment strategies, and describe demographic and clinical characteristics of responders and enrollees. HealthCore/Anthem Research Network, a part of the Health Plan Research Network of the Patient-Centered Clinical Data Research Network, used administrative claims data to identify eligible health plan members for potential participation in the Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness study. We approached health plan members, identified with a validated Patient-Centered Clinical Data Research Network common data model computable phenotype, and their clinical providers during November 2017 to August 2018. Providers were offered the option to exclude their patients' participation in Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness prior to our direct patient (member) outreach. Member identification was in two phases: Phase 1: 1 January 2006 to 1 April 2017, and Phase 2: 1 January 2006 to 2 February 2018. Phase 1 consisted of two batches of mail and one phone call per patient. In Phase 2, which included two similar batches of patients, outreach was via either mail or brochure and one phone call. Phase 1 and Phase 2 included 133,373 and 51,777 members, respectively. We engaged 28,593 providers in Phase 1, and 5077 in Phase 2. In Phase 1, 264,158 mixed email/mail messages were delivered to 133,373 members, followed by 90,481 phone calls from November 2017 to February 2018. In Phase 2, after simple randomization to letter or brochure, 51,777 members were sent email/mail or mailed brochure in three waves from May 2018 to July 2018. In this 9-week period, 51,623 communications were sent to 25,914 members in the email/mail group, and 50,160 brochures to 25,863 in the brochure group. Following email/mail or mailed brochure outreach, 16,624 and 16,580 calls were made to the groups, respectively. Overall, 1549 health plan members visited the study portal by 1 September 2018; 355 electronically signed the Informed Consent Form and enrolled. Mailed brochures drove more portal visits in Phase 2, but a lower percentage of responders enrolled. Recruitment was better in Phase 2-2.3 enrollees per 1000 outreach members versus 1.8 in Phase 1. This study showed the ability of a health plan within Patient-Centered Clinical Data Research Network to identify potential study participants with administrative claims, and use different outreach methods to facilitate recruitment and enrollment for pragmatic clinical trials.

Adult Cancer Survivors' Engagement and Interest in Patient-Centered Research.

Limited information is available about the representativeness of survivors engaging in patient-centered research, despite the potential for threats to generalizability. We thus aimed to assess the representativeness of survivors engaged or interested in research development. We used data from the Health Information National Trends Survey, a nationally representative survey, to identify survivors of adult cancers. Our outcomes of interest were based on responses to questions about engagement or interest in developing patient-centered research. We estimated the ratio of relative frequencies (RRF) and corresponding 95% confidence limits (CL) of sociodemographic and survivorship characteristics between survivors engaged or interested in patient-centered research and the overall survivor population. Our study population comprised 934 survivors, of whom 5% reported being engaged in patient-centered research and 26% reported an interest in participating. Relative frequencies of characteristics were discordant for engaged survivors but largely similar for interested survivors compared with all survivors. In particular, engaged survivors had a higher relative frequency of individuals ages 50 to 64 years (RRF = 1.7; 95% CL, 1.1-2.5), Hispanic (RRF = 2.9; 95% CL, 1.2-6.9), non-Hispanic Black (RRF = 2.9; 95% CL, 1.1-2.5), and unemployment (RRF = 4.7; 95% CL, 1.4-16). We observed several meaningful differences in the characteristics of survivors engaged in patient-centered research compared with all survivors, which raises concerns about the generalizability of findings from such studies. Patient-centered research may not benefit the broader survivor community if survivors engaging in research development are not representative of all survivors. Greater attention to recruiting mechanisms is necessary to avoid creating disparities.

The Molecular Medicine Investigation Unit: Linking Patient Care and Scientific Inquiry in Physician-Scientist Training.

Medical innovation depends on translation, the process of applying clinical insights to solve biological problems, and vice versa, yet existing training programs provide few opportunities for physician-scientists to integrate their clinical and research training. We developed and determined the feasibility and acceptability of a rotation on the Molecular Medicine Investigation Unit (MMIU), a novel program that engages trainees in the deliberate linkage of patient care and scientific inquiry to cultivate their interest and skills in translation. Between July 2017 and January 2019, fourth-year medical students and internal medicine residents were offered a 4-week elective rotation on the MMIU. Supervised by 2 part-time faculty, trainees evaluated patients with unusual and perplexing presentations with the goal of generating hypotheses and a research plan to elucidate the underlying mechanisms of disease. We tracked the development of research hypotheses and resulting projects and surveyed participants about their satisfaction with the program. Over 18 months, 21 trainees (11 medical students and 10 residents) participated in the program and evaluated a total of 70 patients. Trainees generated a mechanistic hypothesis in 45 (64%) cases, and this resulted in a patient-centered research project in 38 (54%) cases. Trainees unanimously agreed that the program gave them an opportunity to integrate their clinical and research training, and many expressed that it reinforced their interests in translational research. With modest funding support, it was feasible to deliver authentic experiences of translational inquiry for medical students and internal medical residents, and these experiences were valued by trainees.

Development of an international standard set of outcome measures for patients with atrial fibrillation: a report of the International Consortium for Health Outcomes Measurement (ICHOM) atrial fibrillation working group.

AimsAs health systems around the world increasingly look to measure and improve the value of care that they provide to patients, being able to measure the outcomes that matter most to patients is vital. To support the shift towards value-based health care in atrial fibrillation (AF), the International Consortium for Health Outcomes Measurement (ICHOM) assembled an international Working Group (WG) of 30 volunteers, including health professionals and patient representatives to develop a standardized minimum set of outcomes for benchmarking care delivery in clinical settings.Methods and resultsUsing an online-modified Delphi process, outcomes important to patients and health professionals were selected and categorized into (i) long-term consequences of disease outcomes, (ii) complications of treatment outcomes, and (iii) patient-reported outcomes. The WG identified demographic and clinical variables for use as case-mix risk adjusters. These included baseline demographics, comorbidities, cognitive function, date of diagnosis, disease duration, medications prescribed and AF procedures, as well as smoking, body mass index (BMI), alcohol intake, and physical activity. Where appropriate, and for ease of implementation, standardization of outcomes and case-mix variables was achieved using ICD codes. The standard set underwent an open review process in which over 80% of patients surveyed agreed with the outcomes captured by the standard set.ConclusionImplementation of these consensus recommendations could help institutions to monitor, compare and improve the quality and delivery of chronic AF care. Their consistent definition and collection, using ICD codes where applicable, could also broaden the implementation of more patient-centric clinical outcomes research in AF.

Neoadjuvant therapy for resectable pancreatic ductal adenocarcinoma: The need for patient-centered research.

Pancreatic ductal adenocarcinoma is an aggressive cancer with high recurrence rates following surgical resection. While adjuvant chemotherapy improves survival, a significant proportion of patients are unable to initiate or complete all intended therapy following pancreatectomy due to postoperative complications or poor performance status. The administration of chemotherapy prior to surgical resection is an alternative strategy that ensures its early and near universal delivery as well as improves margin-negative resection rates and potentially improves long-term survival outcomes. Neoadjuvant therapy is increasingly being recommended to patients with pancreatic ductal adenocarcinoma, however, patient-centered research on its use is lacking. In this review, we highlight opportunities to focus research efforts in the domains of patient preferences, patient-reported outcomes, patient experience, and survivorship. Novel research in these areas may identify relevant barriers and facilitators to the use of neoadjuvant therapy thereby increasing its utilization, improve shared-decision making for patients and providers, and optimize the experience of those undergoing neoadjuvant therapy.

Assessment of the completeness of intervention reporting of randomized clinical trials for alcohol use disorders: Effect of the TIDieR checklist and guide

Background/purposeProperly designed randomized controlled trials (RCTs) are the gold standard in patient-centered clinical research. Incomplete intervention reporting affects the readers' ability to evaluate treatment efficacy. Previous studies show that detailed descriptions of trial interventions remains insufficient for reliable replication. Understanding reporting areas in need of improvement can improve the quality of intervention reporting. MethodsThis cross-sectional review uses the Template for Intervention Description and Replication (TIDieR) checklist to evaluate the quality of intervention reporting in RCTs. The primary outcome was to investigate the completeness of intervention reporting of RCTs reporting outcomes for patients with alcohol use disorder (AUD) published in highly ranked addiction journals. The secondary outcomes were to: 1) evaluate whether publication of the TIDieR checklist resulted in better intervention reporting practices and 2) determine whether particular trial characteristics were associated with the completeness of intervention reporting. ResultsThe final analysis included 56 records. The mean number of reported TIDieR items was 5.1 (SD = 1.47) of a possible 12. TIDieR checklist publication did not increase the average completion of the TIDieR checklist items (p = 0.76). Improved TIDieR adherence was associated with trials with double blinding, non-drug interventions, and CONSORT endorsement. Discussion/conclusionsWe found the reporting of interventions to be inadequate in our sample of AUD-related RCTs. Fundamental details were often not reported, hampering both clinical and research reproducibility. Moving forward, it may be necessary to consider additional mechanisms to either improve TIDieR uptake or to find other solutions to improve intervention reporting.

In Gratitude of 2019 JPCRR Peer Reviewers

Journal of Patient-Centered Research and Reviews gratefully acknowledges the contributions of its submission reviewers from the previous year. Peer review is an essential component to publishing high-quality scientific literature. The editors thank these individuals for their generous volunteerism.

Engaging young African American women breast cancer survivors: A novel storytelling approach to identify patient-centred research priorities.

BackgroundPatient‐centredness is considered an essential aspiration of a high‐quality health‐care system, and patient engagement is a critical precursor to patient‐centred care.ObjectivesTo engage patients, health‐care providers and stakeholders in identifying recommendations to address research and practice gaps that impact young African American breast cancer survivors.MethodsThis paper reported an approach for research priority setting. This approach applies an engagement process (January‐September 2018) of using patient and stakeholder groups, patient storytelling workshops and a culminating storytelling conference in Wisconsin to generate relevant research topics and recommendations. Topics were prioritized using an iterative engagement process. Research priorities and recommendation were ranked over the conference by counting participants’ anonymous votes.ResultsOne hundred attendees (43 patients/family members, 20 providers/researchers and 37 community members) participated in the conference. Five topics were identified as priorities. The results showed that three priority areas received the most votes, specifically community outreach and education, providing affordable health care and engaging in complementary care practice. Stakeholders also agreed it is critical to ‘include youth in the conversation’ when planning for cancer support and educational programmes for caregivers, friends and family members.ConclusionStorytelling as a patient engagement approach can build trust in the patient‐research partnership, ensure that patients are meaningfully engaged throughout the process and capture the diversity of patient experiences and perspectives.

Considerations for using distributed research networks to conduct aspects of randomized trials

Stakeholders in the clinical research enterprise are aligned around the need to make clinical research in general, and randomized controlled trials in particular, more meaningful and efficient. To that end, we have built distributed research networks (DRNs) for the Sentinel System, the National Institutes of Health (NIH) Collaboratory, and the National Patient-Centered Clinical Research Network (PCORnet). DRNs reuse electronic health record (EHR) and claims data for research. The design and use of health data DRNs is complicated by lack of uniformity in data collection, a fragmented healthcare system, and the imperative to protect research participants.We describe the key elements of successful DRNs, as well as methods, challenges, and solutions we have encountered in using DRNs to support different phases of randomized, multi-site, clinical research. This work supports “real-world” efforts to build a learning health system and will enable others to conduct randomized clinical trial research using a DRN.

Ethical Issues in the Design and Conduct of Pragmatic Cluster Randomized Trials in Hemodialysis Care: An Interview Study With Key Stakeholders.

Background:Pragmatic cluster randomized trials (CRTs) offer an opportunity to improve health care by answering important questions about the comparative effectiveness of treatments using a trial design that can be embedded in routine care. There is a lack of empirical research that addresses ethical issues generated by pragmatic CRTs in hemodialysis.Objective:To identify stakeholder perceptions of ethical issues in pragmatic CRTs conducted in hemodialysis.Design:Qualitative study using semi-structured interviews.Setting:In-person or telephone interviews with an international group of stakeholders.Participants:Stakeholders (clinical investigators, methodologists, ethicists and research ethics committee members, and other knowledge users) who had been involved in the design or conduct of a pragmatic individual patient or cluster randomized trial in hemodialysis, or their role would require them to review and evaluate pragmatic CRTs in hemodialysis.Methods:Interviews were conducted in-person or over the telephone and were audio-recorded with consent. Recorded interviews were transcribed verbatim prior to analysis. Transcripts and field notes were analyzed using a thematic analysis approach.Results:Sixteen interviews were conducted with 19 individuals. Interviewees were largely drawn from North America (84%) and were predominantly clinical investigators (42%). Six themes were identified in which pragmatic CRTs in hemodialysis raise ethical issues: (1) patients treated with hemodialysis as a vulnerable population, (2) appropriate approaches to informed consent, (3) research burdens, (4) roles and responsibilities of gatekeepers, (5) inequities in access to research, and (6) advocacy for patient-centered research and outcomes.Limitations:Participants were largely from North America and did not include research staff, who may have differing perspectives.Conclusions:The six themes reflect concerns relating to individual rights, but also the need to consider population-level issues. To date, concerns regarding inequity of access to research and the need for patient-centered research have received less coverage than other, well-known, issues such as consent. Pragmatic CRTs offer a potential approach to address equity concerns and we suggest future ethical analyses and guidance for pragmatic CRTs in hemodialysis embed equity considerations within them. We further note the potential for the co-creation of health data infrastructure with patients which would aid care but also facilitate patient-centered research. These present results will inform planned future guidance in relation to the ethical design and conduct of pragmatic CRTs in hemodialysis.Trial Registration:Registration is not applicable as this is a qualitative study.

Community-Initiated Research Engagement: Equitable Partnership Delivering Research-Ready Faith-Based Ambassadors.

Faith-based communities supporting diverse and underserved communities are increasingly being recognized by health researchers as valued partners for research engagement. Although the "why engage" is clearly documented, the how and lessons learned is less well evidenced. This article describes community-academic collaboration initiated by African American faith-based church leaders to foster equitable partnership, engagement and shared decision making in patient-centered health research initiatives. A phased process of relationship and capacity building was used to found and operationalize a mixed stakeholder community advisory board (CAB). Core phases presented in this article are (1) pre-CAB capacity building, (2) developing the CAB vision and mission, (3) extending CAB capacity, and (4) sustaining CAB capacity. Collaborative governance and shared goal setting delivers research engagement which supports the data needs and aspirations of faith-based communities. Faith-based communities have the capacity to design and deliver community appropriate governance for research engagement.

Barriers to and facilitators for use of augmentative and alternative communication and voice restorative devices in the adult intensive care unit: a scoping review protocol

BackgroundMechanically ventilated patients in the intensive care unit (ICU) experience profound communication impairment, placing them at risk for poor physical and psychological outcomes. Patient communication strategies such as augmentative and alternative communication (AAC) and voice restorative devices are recommended to facilitate communication. These strategies, however, are inconsistently adopted in ICU practice signaling utilization barriers. Our objective is to map and synthesize the current evidence-base for stakeholder-reported barriers and facilitators to patient communication strategy utilization for adults with an advanced airway in the ICU.Methods and analysisWe will use Arskey and O’Malley’s recommended methods to conduct a scoping review using a rapid review framework to streamline the process. A single reviewer will conduct a search and an initial screen of titles and abstracts from five electronic databases (MEDLINE, EMBASE, the Cochrane Library, Cumulative Index to Nursing and Allied Health Literature [CINAHL], and PsychInfo) from 1990 to present to identify English language peer-reviewed studies. Subsequently, two reviewers will independently screen a shorter list of studies for inclusion. We will also search the reference lists of eligible studies. Two reviewers will independently extract study characteristics, communication strategy, and stakeholder reported barriers and facilitators. We will code and categorize the extracted barriers and facilitators according to the Theoretical Domains Framework (TDF), an integrative framework of behavior change.DiscussionTo our knowledge, this will be the first scoping review to map and synthesize reported barriers and facilitators to communication strategy utilization in the adult ICU using a theoretical framework. The results of this scoping review will help to identify trends and gaps in the current evidence-base and support recommendations for improving patient-centered practice, policy, and research related to successfully establishing ICU patient communication.