Dataset Information

Implementation of Pharmacogenetics in Primary Care: A Multi-Stakeholder Perspective.

ABSTRACT: Introduction:Aberrant pharmacogenetic variants occur in a high proportion of people and might be relevant for the prescription of over 26 drugs in primary care. Early identification of patients who metabolize these drugs more rapidly or slowly than average could predict therapeutic effectivity and safety. Yet implementation of pharmacogenetics is progressing slowly. A high public health impact can potentially be achieved by increasing the proportion of people tested, when and where eligible according to clinical validity and utility. Methods:In this study we defined actions, roles, and responsibilities for implementation of pharmacogenetics in primary care in consultation with stakeholder groups, by using a three-step mixed-methods approach. First, to define barriers and facilitators, public pharmacists (n = 24), primary care physicians (n = 8), and patients (n = 21) participated in focus groups and face-to-face interviews. Second, a multidisciplinary expert meeting (n = 16) was organized to define desired actions, roles, and responsibilities. Third, an online Delphi Study (n = 18) was conducted to prioritize the designated actions. Results:For the integration of pharmacogenetics in primary care guidelines and practice, lack of evidence for clinical utility was mentioned as a main barrier. Furthermore, reimbursement, and facilitation of data registration and sharing were considered as key elements for future routine application of pharmacogenetic testing. Moreover, the division of roles and responsibilities, especially between general practitioners and pharmacists, is currently perceived as unclear. Sixteen actions in these four areas (clinical utility, reimbursement, data registration and sharing, and roles and responsibilities) were formulated and assigned to specific actors during the expert meeting. After ranking these 16 actions in the Delphi Study, nine actions remained pertinent, covering the four areas with at least one action. However, participants showed low agreement on the prioritization of the different actions, illustrating their different perspectives and the need to attune between them. Discussion:Stakeholders together were able to formulate required actions to achieve true integration of pharmacogenetics in primary care, but no consensus could be achieved on the prioritization of the actions. Coordination of the current independent initiatives by the different stakeholders could facilitate effective and efficient implementation of useful pharmacogenetics in primary care.

SUBMITTER: Rigter T

PROVIDER: S-EPMC7006602 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Implementation of Pharmacogenetics in Primary Care: A Multi-Stakeholder Perspective.

Rigter Tessel T Jansen Marleen E ME de Groot Jordy M JM Janssen Susan W J SWJ Rodenburg Wendy W Cornel Martina C MC

Frontiers in genetics 20200131

<h4>Introduction</h4>Aberrant pharmacogenetic variants occur in a high proportion of people and might be relevant for the prescription of over 26 drugs in primary care. Early identification of patients who metabolize these drugs more rapidly or slowly than average could predict therapeutic effectivity and safety. Yet implementation of pharmacogenetics is progressing slowly. A high public health impact can potentially be achieved by increasing the proportion of people tested, when and where eligi ...[more]

PMID: 32076434

Similar Datasets

Project description:BackgroundSevere primary insulin-like growth factor-I (IGF-I) deficiency (SPIGFD) is a rare growth disorder characterized by short stature (standard deviation score [SDS] ≤ 3.0), low circulating concentrations of IGF-I (SDS ≤ 3.0), and normal or elevated concentrations of growth hormone (GH). Laron syndrome is the best characterized form of SPIGFD, caused by a defect in the GH receptor (GHR) gene. However, awareness of SPIGFD remains low, and individuals living with SPIGFD continue to face challenges associated with diagnosis, treatment and care.ObjectiveTo gather perspectives on the key challenges for individuals and families living with SPIGFD through a multi-stakeholder approach. By highlighting critical gaps in the awareness, diagnosis, and management of SPIGFD, this report aims to provide recommendations to improve care for people affected by SPIGFD globally.MethodsAn international group of clinical experts, researchers, and patient and caregiver representatives from the SPIGFD community participated in a virtual, half-day meeting to discuss key unmet needs and opportunities to improve the care of people living with SPIGFD.ResultsAs a rare disorder, limited awareness and understanding of SPIGFD amongst healthcare professionals (HCPs) poses significant challenges in the diagnosis and treatment of those affected. Patients often face difficulties associated with receiving a formal diagnosis, delayed treatment initiation and limited access to appropriate therapy. This has a considerable impact on the physical health and quality of life for patients, highlighting a need for more education and clearer guidance for HCPs. Support from patient advocacy groups is valuable in helping patients and their families to find appropriate care. However, there remains a need to better understand the burden that SPIGFD has on individuals beyond height, including the impact on physical, emotional, and social wellbeing.ConclusionsTo address the challenges faced by individuals and families affected by SPIGFD, greater awareness of SPIGFD is needed within the healthcare community, and a consensus on best practice in the care of individuals affected by this condition. Continued efforts are also needed at a global level to challenge existing perceptions around SPIGFD, and identify solutions that promote equitable access to appropriate care. Medical writing support was industry-sponsored.

Project description:In primary health care, multi-stakeholder partnerships between clinicians, policy makers, academic representatives and other stakeholders to improve service delivery are becoming more common. Literature on processes and approaches that enhance partnership effectiveness is growing. However, evidence on the performance of the measures of partnership functioning and the achievement of desired outcomes is still limited, due to the field's definitional ambiguity and the challenges inherent in measuring complex and evolving collaborative processes. Reliable measures are needed for external or self-assessment of partnership functioning, as intermediate steps in the achievement of desired outcomes. We adapted the Partnership Self-Assessment Tool (PSAT) and distributed it to multiple stakeholders within five partnerships in Canada and Australia. The instrument contained a number of partnership functioning sub-scales. New sub-scales were developed for the domains of communication and external environment. Partnership synergy was assessed using modified Partnership Synergy Processes and Partnership Synergy Outcomes sub-scales, and a combined Partnership Synergy scale. Ranking by partnership scores was compared with independent ranks based on a qualitative evaluation of the partnerships' development. 55 (90%) questionnaires were returned. Our results indicate that the instrument was capable of discriminating between different levels of dimensions of partnership functioning and partnership synergy even in a limited sample. The sub-scales were sufficiently reliable to have the capacity to discriminate between individuals, and between partnerships. There was negligible difference in the correlations between different partnership functioning dimensions and Partnership Synergy sub-scales. The Communication and External Environment sub-scales did not perform well metrically. The adapted partnership assessment tool is suitable for assessing the achievement of partnership synergy and specific indicators of partnership functioning. Further development of Communication and External Environment sub-scales is warranted. The instrument could be applied to assess internal partnership performance on key indicators across settings, in order to determine if the collaborative process is working well.

Project description:BackgroundAdvance psychiatric agreements could guide medical teams in providing care consistent with the incapacitated service user's wishes. However, these types of agreements are rarely completed in Asian settings. What challenges can a traditionally paternalistic healthcare system expect to encounter when attempting to implement psychiatric advance directives?MethodsWe answered this research question by exploring the cultural, administrative and logistical challenges that might impede the implementation of the system supporting the service. We interviewed key stakeholders, 28 service users and 22 service providers, to seek their views and interests in the implementation of directives. We structured our analyses along a literature-review-based framework designed to guide further implementation studies, proposed by Nicaise and colleagues (2013). Accordingly, we divided our inductively generated themes into four longitudinal categories: pre-development stage, development stage, implementation stage, post-implementation stage.ResultsOverall, the findings indicated that many service users and service providers are interested in advance care planning. They believed that foreseeable challenges could be overcome with appropriate measures. However, the multiple challenges of implementation led some service providers to be ambivalent about their implementation and led service users to dismiss them. Specifically, factors related to the local culture in Singapore necessitated adjustments to the content and structure of the directives. These include language barriers in a multicultural society, conflicting wishes in a collectivist society, taboos for speaking about undesirable outcomes in a traditionalist society, and time limitations in a fast-paced society.ConclusionWhile culture-specific changes may be required to enable service users in a small Asian country to employ existing advance psychiatric agreement approaches, service providers and service users see their benefits. However, service providers must be mindful not to assume that service users are willing to defer every decision to their physician.

Project description:BACKGROUND:Pharmacogenetic testing (PGx) has the potential to improve the quality of psychiatric prescribing by considering patients' genetic profile. However, there is limited scientific evidence supporting its efficacy or guiding its implementation. The Precision Medicine in Mental Health (PRIME) Care study is a pragmatic randomized controlled trial evaluating the effectiveness of a specific commercially-available pharmacogenetic (PGx) test to inform antidepressant prescribing at 22 sites across the U.S. Simultaneous implementation science methods using the Consolidated Framework for Implementation Research (CFIR) are integrated throughout the trial to identify contextual factors likely to be important in future implementation of PGx. The goal of this study was to understand providers' perceptions of PGx for antidepressant prescribing and implications for future implementation. METHODS:Qualitative focus groups (n?=?10) were conducted at the beginning of the trial with Primary Care and Mental Health providers (n?=?31) from six PRIME Care sites. Focus groups were audio-recorded and transcribed and data were analyzed using rapid analytic procedures organized by CFIR domains. RESULTS:Analysis revealed themes in the CFIR Intervention Characteristics domain constructs of Evidence, Relative Advantage, Adaptability, Trialability, Complexity, and Design that are important for understanding providers' perceptions of PGx testing. Results indicate: 1) providers had limited experience and knowledge of PGx testing and its evidence base, particularly for psychiatric medications; 2) providers were hopeful that PGx could increase their precision in depression prescribing and improve patient engagement, but were uncertain about how results would influence treatment; 3) providers were concerned about potential misinterpretation of PGx results and how to incorporate testing into their workflow; 4) primary care providers were less familiar and comfortable with application of PGx testing to antidepressant prescribing than psychiatric providers. CONCLUSIONS:Provider perceptions may serve as facilitators or barriers to implementation of PGx for psychiatric prescribing. Incorporating implementation science into the conduct of the RCT adds value by uncovering factors to be addressed in preparing for future implementation, should the practice prove effective. TRIAL REGISTRATION:ClinicalTrials.gov ID: NCT03170362 ; Registered 31 May 2017.

Project description:BackgroundADHD commonly co-occurs in children and parents. When ADHD is untreated in parents, it contributes to negative child developmental and treatment outcomes. Screening for parent and child ADHD co-occurrence in pediatric primary care may be an effective strategy for early identification and treatment. There is no data on whether this screening model can be implemented successfully and there exists limited guidance on how to effectively approach parents about their own ADHD in pediatric settings. Even greater sensitivity may be required when engaging with families living in urban, low SES communities due to systemic inequities, mistrust, and stigma.MethodsThe current pilot study described the first 6 months of implementation of a parent and child ADHD screening protocol in urban pediatric primary care clinics serving a large population of families insured through Medicaid. Parents and children were screened for ADHD symptoms at annual well-child visits in pediatric primary care clinics as part of standard behavioral health screening. Independent stakeholder group meetings were held to gather feedback on factors influencing the implementation of the screening and treatment strategies. Mixed methods were used to examine initial screening completion rates and stakeholder perspectives (i.e., parents, primary care office staff, pediatricians, and behavioral health providers) on challenges of implementing the screening protocol within urban pediatric primary care.ResultsScreening completion rates were low (19.28%) during the initial 6-month implementation period. Thematic analysis of stakeholder meetings provided elaboration on the low screening completion rates. Identified themes included: 1) divergence between provider enthusiasm and parent hesitation; 2) parent preference versus logistic reality of providers; 3) centering the experiences of people with marginalized identities; and 4) sensitivity when discussing parent mental health and medication.ConclusionsFindings highlight the importance of developing flexible approaches to screening parent and child ADHD in urban pediatric health settings and emphasize the importance of cultural sensitivity when working with marginalized and under-resourced families.Trial registrationNCT04240756 (27/01/2020).

Project description:Cell-based therapies have been making great advances toward clinical reality. Despite the increase in trial activity, few therapies have successfully navigated late-phase clinical trials and received market authorization. One possible explanation for this is that additional tools and technologies to enable their development have only recently become available. To support the safety evaluation of cell therapies, the Health and Environmental Sciences Institute Cell Therapy-Tracking, Circulation and Safety Committee, a multisector collaborative committee, polled the attendees of the 2017 International Society for Cell & Gene Therapy conference in London, UK, to understand the gaps and needs that cell therapy developers have encountered regarding safety evaluations in vivo. The goal of the survey was to collect information to inform stakeholders of areas of interest that can help ensure the safe use of cellular therapeutics in the clinic. This review is a response to the cellular imaging interests of those respondents. The authors offer a brief overview of available technologies and then highlight the areas of interest from the survey by describing how imaging technologies can meet those needs. The areas of interest include imaging of cells over time, sensitivity of imaging modalities, ability to quantify cells, imaging cellular survival and differentiation and safety concerns around adding imaging agents to cellular therapy protocols. The Health and Environmental Sciences Institute Cell Therapy-Tracking, Circulation and Safety Committee believes that the ability to understand therapeutic cell fate is vital for determining and understanding cell therapy efficacy and safety and offers this review to aid in those needs. An aim of this article is to share the available imaging technologies with the cell therapy community to demonstrate how these technologies can accomplish unmet needs throughout the translational process and strengthen the understanding of cellular therapeutics.

Dataset Information

Implementation of Pharmacogenetics in Primary Care: A Multi-Stakeholder Perspective.

Publications

Implementation of Pharmacogenetics in Primary Care: A Multi-Stakeholder Perspective.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets