Physicians' perspectives regarding pragmatic clinical trials.
Ontology highlight
ABSTRACT: Aim
Practicing physicians inevitably become involved in pragmatic clinical trials (PCTs), including comparative effectiveness research. We sought to identify physicians' perspectives related to PCTs.Methods
In-depth semistructured interviews with 20 physicians in the USA.Results
Although physicians are generally willing to participate in PCTs, their support is predicated on several factors including expected benefits, minimization of time and workflow burdens and physician engagement. Physicians communicated a desire to respect patients' rights and interests while maintaining a high level of care.Conclusion
Future work is needed to systematically assess the impact of PCTs on clinicians in meeting their ethical obligations to patients and the burdens clinicians are willing to accept in exchange for potential benefits.
SUBMITTER: Topazian R
PROVIDER: S-EPMC4975022 | biostudies-literature | 2016 Aug
REPOSITORIES: biostudies-literature
Publications
Physicians' perspectives regarding pragmatic clinical trials.
Topazian Rachel R Bollinger Juli J Weinfurt Kevin P KP Dvoskin Rachel R Mathews Debra D Brelsford Kathleen K DeCamp Matthew M Sugarman Jeremy J
Journal of comparative effectiveness research 20160715 5
<h4>Aim</h4>Practicing physicians inevitably become involved in pragmatic clinical trials (PCTs), including comparative effectiveness research. We sought to identify physicians' perspectives related to PCTs.<h4>Methods</h4>In-depth semistructured interviews with 20 physicians in the USA.<h4>Results</h4>Although physicians are generally willing to participate in PCTs, their support is predicated on several factors including expected benefits, minimization of time and workflow burdens and physicia ...[more]
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Project description:BackgroundCluster randomized trials (CRTs) are trials in which intact groups such as hemodialysis centers or shifts are randomized to treatment or control arms. Pragmatic CRTs have been promoted as a promising trial design for nephrology research yet may also pose ethical challenges. While randomization occurs at the cluster level, the intervention and data collection may vary in a CRT, challenging the identification of research participants. Moreover, when a waiver of patient consent is granted by a research ethics committee, there is an open question as to whether and to what degree patients should be notified about ongoing research or be provided with a debrief regarding the nature and results of the trial upon completion. While empirical and conceptual research exploring ethical issues in pragmatic CRTs has begun to emerge, there has been limited discussion with patients, families, or caregivers of patients undergoing hemodialysis.ObjectiveTo explore with patients and families with experience of hemodialysis research the challenges raised by different approaches to designing pragmatic CRTs in hemodialysis. Specifically, their perceptions of (1) the use of a waiver of consent, (2) notification processes and information provided to participants, and (3) any other concerns about cluster randomized designs in hemodialysis.DesignFocus group and interview discussions of hypothetical clinical trial designs.SettingFocus groups and interviews were conducted in-person or via videoconference or telephone.ParticipantsPatient partners in hemodialysis research, defined as patients with personal experience of dialysis or a family member who had experience supporting a patient receiving hemodialysis, who have been actively involved in discussions to advise a research team on the design, conduct, or implementation of a hemodialysis trial.MethodsParticipants were invited to participate in focus groups or individual discussions that were audio recorded with consent. Recorded interviews were transcribed verbatim prior to analysis. Transcripts were analyzed using a thematic analysis approach.ResultsTwo focus groups, three individual interviews, and one interview involving a patient and family member were conducted with 17 individuals between February 2019 and May 2020. Participants expressed support for approaches that emphasized patient choice. Disclosure of patient-relevant risks and information were key themes. Both consent and notification processes served to generate trust, but bypassing patient choice was perceived as undermining this trust. Participants did not dismiss the option of a waiver of consent. They were, however, more restrictive in their views about when a waiver of consent may be acceptable. Patient partners were skeptical of claims to impracticability based on costs or the time commitments for staff.LimitationsAll participants were from Canada and had been involved in the design or conduct of a trial, limiting the degree to which results may be extrapolated.ConclusionsGiven the preferences of participants to be afforded the opportunity to decide about trial participation, we argue that investigators should thoroughly investigate approaches that allow participants to make an informed choice regarding trial participation. In keeping with the preference for autonomous choice, there remains a need to further explore how consent approaches can be designed to facilitate clinical trial conduct while meeting their ethical requirements. Finally, further work is needed to define the limited circumstances in which waivers of consent are appropriate.
| S-EPMC8317238 | biostudies-literature
Project description:BackgroundThe requirement to obtain written informed consent may undermine the potential of pragmatic randomized clinical trials (pRCTs) to improve evidence-based care. This requirement could compromise trials statistical power or even force it to close them down prematurely. However, recent data from the U.S. and Spain suggest that a majority of the public endorses written consent for low-risk pRCTs. The present manuscript assesses whether this view is shared by patients.MethodsThis was a cross-sectional, probability-based survey, with a 2 × 2 factorial design, assessing support for written informed consent versus verbal consent or general notification for two low-risk pRCTs in hypertension, one comparing 2 drugs with similar risk/benefit profiles and the other comparing the same drug being taken in the morning or at night. This web-based survey was conducted in May 2016. Two-thousand and eight adults who were representative of the Spanish population participated in the survey (response rate: 61%). Of these 2008 respondents, 338 indicated that they had been diagnosed with hypertension and were being treated with prescription medicines for this condition at the time of responding to the survey. The primary outcome measures were respondents' personal preference and recommendation to a research ethics committee regarding the use of written informed consent versus verbal consent or general notification.ResultsOverall, 74% of the 338 patient respondents endorsed written consent. In both scenarios, general notification received significantly more support (30.6%-44.7%) than verbal consent (13.3%-17.6%). 43% of respondents preferred and/or recommended general notification rather than written consent.ConclusionsAs in the survey of the general public, more patients endorsed written consent than the alternative option. However, two factors suggest that a different approach to written consent should be investigated for low-risk pRCTs: a) a substantial minority of respondents supported general notification, b) data from the US have shown that most patients who prefer written consent are willing to forego it if obtaining written consent makes the trial too difficult to be conducted; and c) 2016 CIOMS guidelines endorse waivers of consent when the trial fulfills specific conditions. Surveys in other EU countries are needed to assess what patients believe towards pRCTs. If similar results to that reported in this study are found, it is foreseeable that with educational efforts, general notification could be an acceptable and widespread approach to the conduct of low-risk pRCTs.
| S-EPMC5604493 | biostudies-literature
Project description:IntroductionNumerous arguments have been advanced for broadly sharing de-identified, participant-level clinical trial data. However, data sharing in pragmatic clinical trials (PCTs) presents ethical challenges. While prior scholarship has described aspects of PCTs that raise distinct considerations for data sharing, there have been no reports of the experiences of those at the leading edge of data-sharing efforts for PCTs, including how these particular challenges have been navigated. To address this gap, we conducted interviews with key stakeholders, with a focus on the ethical issues presented by sharing data from PCTs.MethodsWe recruited respondents using purposive sampling to reflect the range of stakeholder groups affected by efforts to expand PCT data sharing. Through semi-structured interviews, we explored respondents' experiences and perceptions about sharing de-identified, individual-level data from PCTs. An integrated approach was used to identify and describe key themes.ResultsWe conducted 40 interviews between April and September 2022. Five overarching themes emerged through analysis: (1) challenges in sharing data collected under a waiver or alteration of consent; (2) conflicting views regarding PCT patient-subject preferences for data sharing; (3) identification of respect-promoting practices beyond consent; (4) concerns about elevated risks or burdens from sharing PCT data; and (5) diverse views about the likely benefits resulting from sharing PCT data.ConclusionOur data indicate unresolved tensions in how to fulfill the expectation to broadly share de-identified, individual-level data from PCTs, and suggest that those promulgating and implementing data-sharing policies must be sensitive to PCT-specific considerations. Future work could inform efforts to tailor data-sharing policy and practice to reflect the challenges presented by PCTs, including sharing experiences from trials that have successfully navigated these tensions.
| S-EPMC10797577 | biostudies-literature
Project description:BackgroundInternational clinical trials are now rapidly expanding into Asia. However, the proportion of global trials is higher in South Korea compared to Japan despite implementation of similar governmental support in both countries. The difference in clinical trial environment might influence the respective physicians' attitudes and experience towards clinical trials. Therefore, we designed a questionnaire to explore how physicians conceive the issues surrounding clinical trials in both countries.MethodsA questionnaire survey was conducted at Kyoto University Hospital (KUHP) and Seoul National University Hospital (SNUH) in 2008. The questionnaire consisted of 15 questions and 2 open-ended questions on broad key issues relating to clinical trials.ResultsThe number of responders was 301 at KUHP and 398 at SNUH. Doctors with trial experience were 196 at KUHP and 150 at SNUH. Among them, 12% (24/196) at KUHP and 41% (61/150) at SUNH had global trial experience. Most respondents at both institutions viewed clinical trials favorably and thought that conducting clinical trials contributed to medical advances, which would ultimately lead to new and better treatments. The main reason raised as a hindrance to conducting clinical trials was the lack of personnel support and time. Doctors at both university hospitals thought that more clinical research coordinators were required to conduct clinical trials more efficiently. KUHP doctors were driven mainly by pure academic interest or for their desire to find new treatments, while obtaining credits for board certification and co-authorship on manuscripts also served as motivation factors for doctors at SNUH.ConclusionsOur results revealed that there might be two different approaches to increase clinical trial activity. One is a social level approach to establish clinical trial infrastructure providing sufficient clinical research professionals. The other is an individual level approach that would provide incentives to encourage doctors to participate in and conduct clinical trials.
| S-EPMC3830111 | biostudies-literature
Project description:Pragmatic clinical trials are conducted under the real-world conditions of clinical care delivery. As a result, these trials yield findings that are highly generalizable to the nonresearch setting, identify interventions that are readily translatable into clinical practice, and cost less than trials that require extensive research infrastructures. Maintenance dialysis is a setting especially well suited for pragmatic trials because of inherently frequent and predictable patient encounters, highly granular and uniform data collection, use of electronic data systems, and delivery of care by a small number of provider organizations to approximately 90% of patients nationally. Recognizing the potential for pragmatic trials to generate much needed evidence to guide the care of patients receiving maintenance dialysis, the Kidney Health Initiative assembled a group of individuals with relevant expertise from academia, industry, and government to provide the nephrology community with information about the design and conduct of such trials, with a specific focus on the dialysis setting. Here, we review this information, and where applicable, use experience from the ongoing Time to Reduce Mortality in End Stage Renal Disease Trial, a large cluster-randomized, pragmatic trial evaluating hemodialysis session duration, to illustrate challenges and solutions to operational, ethical, and regulatory issues.
| S-EPMC5042681 | biostudies-literature
Project description:BackgroundThere are unique opportunities related to the design and conduct of pragmatic trials embedded in health insurance plans, which have longitudinal data on member/patient demographics, dates of coverage, and reimbursed medical care, including prescription drug dispensings, vaccine administrations, behavioral healthcare encounters, and some laboratory results. Such trials can be large and efficient, using these data to identify trial-eligible patients and to ascertain outcomes.MethodsWe use our experience primarily with the National Institutes of Health Pragmatic Trials Collaboratory Distributed Research Network, which comprises health plans that participate in the US Food & Drug Administration's Sentinel System, to describe lessons learned from the conduct and planning of embedded pragmatic trials.ResultsInformation is available for research on more than 75 million people with commercial or Medicare Advantage health plans. We describe three studies that have used or plan to use the Network, as well as a single health plan study, from which we glean our lessons learned.ConclusionsStudies that are conducted in health plans provide much-needed evidence to drive clinically meaningful changes in care. However, there are many unique aspects of these trials that must be considered in the planning, implementation, and analytic phases. The type of trial best suited for studies embedded in health plans will be those that require large sample sizes, simple interventions that could be disseminated through health plans, and where data available to the health plan can be leveraged. These trials hold potential for substantial long-term impact on our ability to generate evidence to improve care and population health.
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Project description:Clinical trials test new ways to prevent, detect, diagnose, or treat diseases. Researchers have found that minority patients are willing to participate in clinical trials, yet these patients have barriers which hinder their access to trials.To explore African American women's participation in breast cancer clinical trials, eight focus groups were conducted with breast cancer patients, family members/care givers, religious leaders, and healthcare providers to gather information on the perspectives and opinions on the topic. The focus group conversations were transcribed, and transcripts were imported into QSR International's NVivo 10 software. The transcripts were organized into folders based on four categories. The content analysis performed was based on recordings and notes.The following themes were generated as a result of conducting these focus groups and gathering information on the perspectives and opinions about participating in clinical trials, based on the groups who participated: Promoting participation in research; Personal experience with cancer; Support and support services; Awareness, knowledge, and experience with clinical trials; Providers' roles in clinical trials.The data collected in this study present several actionable themes that, if addressed by individual researchers and the medical community at large, could increase participation in clinical trials by African American patients. They also provide a deeper and more nuanced understanding of the factors influencing African American patients' decisions around participating in clinical trials.
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Project description:BACKGROUND:Physicians are in an ideal position to describe the impact of medication non-medical switching (switching commonly due to formulary changes by insurer for reasons unrelated to patient health) on their practice dynamics and patient care. We sought to examine physicians' openness to requests for non-medical switching and their experiences and opinions regarding the impact of non-medical switching on their practice, staff and patients. METHODS:An online survey of randomly-sampled physicians spending ≥10% of time providing patient care and having received ≥1 non-medical switch request during the prior 12-months. The impact of non-medical switching on clinical decision-making process; professional experience with clinical practice, patient-physician relationship, insurance process; and perceived impact on practice, staff and patients were assessed. Weighted percent responses were calculated. RESULTS:We sampled 1,010 physicians (response rate = 55.5%). Many responded being frequently not amenable (26.0%) or had reservations (41.8%) to non-medical switch requests; with >50% indicating patient stability on current therapy and suboptimal alternatives as factors frequently influencing amenability. Physicians agreed non-medical switching can create ethical concerns (clinical judgement, autonomy, ability to treat per guidelines; 74.8%, 82.3%, 53.5%, respectively), while forcing them to take responsibility for insurers' decisions (81.1%) and diverting their clinical time (84.3%). Most indicated non-medical switching increased practice burden (administrative, non-billable interactions, additional staffing, non-office patient contact, calls to/from the pharmacy; 85.0%, 72.5%, 62.2%, 64.2%, 69.5%, respectively). Physicians felt insurer processes discouraged non-medical switch challenges (76.7%) and required inconvenient lengths-of-time (76.1%) speaking to insurer representatives without proper expertise (62.0%). They believed non-medical switching negatively impacted aspects of care (effectiveness, side-effects, medication adherence and abandonment, out-of-pocket costs, medication errors; 46.5%, 53.2%, 50.6%, 49.4%, 59.6%, 54.5%, respectively). CONCLUSIONS:Physicians were frequently not amenable or had reservations regarding non-medical switching. They noted ethical concerns due to non-medical switching. Most felt non-medical switches burdened their practice and negatively impacted care.
| S-EPMC6953849 | biostudies-literature
Project description:Randomized controlled trials in CKD lag in number behind those of other chronic diseases, despite the high morbidity and mortality experienced by patients with kidney disease and the exorbitant costs of their health care. Observational studies of CKD frequently yield seemingly paradoxic associations of traditional risk factors with outcomes, making it difficult to extrapolate the results of trials conducted in people with normal kidney function to patients with CKD. However, many completed trials in CKD have been limited by intermediate outcomes of unclear clinical significance or narrow eligibility criteria that limit external validity, and implementation of proven therapies remains a challenge. It is therefore imperative that the nephrology community capitalize on recent interest in novel approaches to trial design, such as pragmatic clinical trials. These trials are meant to promote research within real world settings to yield clinically relevant results with greater applicability than those of traditional trials, while maintaining many advantages, such as controlling for potential sources of bias. We provide a description of pragmatic clinical trials and a discussion of advantages, disadvantages, and practical challenges inherent to this study design, in the context of specific scientific questions relevant to patients with CKD.
| S-EPMC5042675 | biostudies-literature
Project description:PURPOSE:The prevalence and nature of clinical pharmacy services in academic emergency departments (EDs) were studied. METHODS:A Web-based survey instrument consisting of questions regarding clinical pharmacy services available in the ED was developed based on a review of the current literature and expert consensus. The revised instrument was sent to a representative of all emergency medicine (EM) residency programs listed in the Society for Academic Emergency Medicine residency catalog in June 2006. The survey included questions addressing characteristics of the institution and the availability and nature of various pharmacy services in the ED. EM physicians were deliberately targeted so that the results would represent the ED staff's perceptions of their use of pharmacy services. Only respondents' primary residency hospital sites were considered. Data were compiled and analyzed using descriptive statistics and 95% confidence intervals. RESULTS:Of the 135 EM residency programs surveyed, 99 responses (73%) were received. Eight percent of institutions reported that a dedicated pharmacist was available in the ED 24 hours a day, 22% reported partial coverage in the ED, and 70% reported no coverage. Six percent reported the presence of a satellite pharmacy located in the ED that was staffed by a pharmacist. The most common clinical pharmacy services reported in EDs with pharmacy coverage were modification of inventory according to formulary status, provision of drug or toxicology information, and adverse-drug-event reporting. CONCLUSION:A minority of respondents from academic EDs reported that clinical services are provided by a pharmacist working in the ED.
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