Accelerating clinical trial implementation in the context of the COVID-19 pandemic: challenges, lessons learned and recommendations from DisCoVeRy and the EU-SolidAct EU response group.
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ABSTRACT:
SUBMITTER: EU-Response investigators group
PROVIDER: S-EPMC8572734 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:The recipients of NIH's Clinical and Translational Science Awards (CTSA) have worked for over a decade to build informatics infrastructure in support of clinical and translational research. This infrastructure has proved invaluable for supporting responses to the current COVID-19 pandemic through direct patient care, clinical decision support, training researchers and practitioners, as well as public health surveillance and clinical research to levels that could not have been accomplished without the years of ground-laying work by the CTSAs. In this paper, we provide a perspective on our COVID-19 work and present relevant results of a survey of CTSA sites to broaden our understanding of the key features of their informatics programs, the informatics-related challenges they have experienced under COVID-19, and some of the innovations and solutions they developed in response to the pandemic. Responses demonstrated increased reliance by healthcare providers and researchers on access to electronic health record (EHR) data, both for local needs and for sharing with other institutions and national consortia. The initial work of the CTSAs on data capture, standards, interchange, and sharing policies all contributed to solutions, best illustrated by the creation, in record time, of a national clinical data repository in the National COVID-19 Cohort Collaborative (N3C). The survey data support seven recommendations for areas of informatics and public health investment and further study to support clinical and translational research in the post-COVID-19 era.
| S-EPMC8209435 | biostudies-literature
Project description:BackgroundHemolytic uremic syndrome (HUS) is a rare condition which diagnosed with the triad of thrombocytopenia, microangiopathic hemolytic anemia, and acute renal injury. There is a high requirement for research to discover treatments. HUS registries can be used as an important information infrastructure. In this study, we identified and compared the different features of HUS registries to present a guide for the development and implementation of HUS registries.ResultsThe purposes of registries were classified as clinical (9 registries), research (7 registries), and epidemiological (5 registries), and only 3 registries pursued all three types of purposes. The data set included demographic data, medical and family history, para-clinical and diagnostic measures, treatment and pharmacological data, complications, and outcomes. The assessment strategies of data quality included monthly evaluation and data audit, the participation of physicians to collect data, editing and correcting data errors, increasing the rate of data completion, following guidelines and data quality training, using specific data quality indicators, and real-time evaluation of data at the time of data entry. 8 registries include atypical HUS patients, and 7 registries include all patients regardless of age. Only two registries focused on children. 4 registries apply prospective and 4 applied both prospective, and retrospective data collection. Finally, specialized hospitals were the main data source for these registries.ConclusionBased on the findings, we suggested a learning framework for developing and implementing an HUS registry. This framework includes lessons learned and suggestions for HUS registry purposes, minimum data set, data quality assurance, data collection methods, inclusion and exclusion criteria as well as data sources. This framework can help researchers develop HUS registries.
| S-EPMC8146148 | biostudies-literature
Project description:An important aim of clinical prediction models is to positively impact clinical decision making and subsequent patient outcomes. The impact on clinical decision making and patient outcome can be quantified in prospective comparative-ideally cluster-randomized-studies, known as 'impact studies'. However, such impact studies often require a lot of time and resources, especially when they are (cluster-)randomized studies. Before envisioning such large-scale randomized impact study, it is important to ensure a reasonable chance that the use of the prediction model by the targeted healthcare professionals and patients will indeed have a positive effect on both decision making and subsequent outcomes. We recently performed two differently designed, prospective impact studies on a clinical prediction model to be used in surgical patients. Both studies taught us new valuable lessons on several aspects of prediction model impact studies, and which considerations may guide researchers in their decision to conduct a prospective comparative impact study. We provide considerations on how to prepare a prediction model for implementation in practice, how to present the model predictions, and how to choose the proper design for a prediction model impact study.
| S-EPMC6460651 | biostudies-literature
Project description:This study uses data collected in the intervention classrooms (N = 22) of Head Start REDI (Research-based, Developmentally Informed), a randomized clinical trial testing the efficacy of a comprehensive preschool curriculum targeting children's social-emotional competence, language, and emergent literacy skills delivered by teachers who received weekly coaching support. Multiple dimensions of implementation (Dosage, Fidelity, Generalization, and Child Engagement) were assessed across curriculum components. Results indicated that REDI Trainers perceived significant growth in teacher implementation quality over time but that patterns differed by implementation dimension. Dosage and Fidelity of all intervention components were high at the beginning of the year and remained so over time while Generalization was low at baseline but increased significantly across the year. Variation in implementation was associated with variation on several child outcome measures in the social-emotional domain but not in the language and literacy domains.
| S-EPMC3404616 | biostudies-literature
Project description:Global health education programs should strive continually to improve the quality of education, increase access, create communities that foster excellence in global health practices, and ensure sustainability. The COVID-19 pandemic forced the University of Minnesota's extensive global health education programs, which includes a decade of hybrid online and in-person programing, to move completely online. We share our experience, a working framework for evaluating global health educational programming, and lessons learned. Over the decades we have moved from a predominantly passive, lecture-based, in-person course to a hybrid online (passive) course with an intensive hands-on 2-week requirement. The pandemic forced us to explore new active online learning models. We retained our on-demand, online passive didactics, which used experts' time efficiently and was widely accessible and well received. In addition, we developed a highly effective synchronous online component that we felt replaced some of the hands-on activities effectively and led us to develop new and innovative "hands-on" experiences. This new, fully online model combining quality asynchronous and synchronous learning provided many unanticipated advantages, such as increasing access while decreasing our carbon footprint dramatically. By sharing our experience, lessons learned, and resources, we hope to inspire other programs likewise to innovate to improve quality, access, community, and sustainability in global health, especially if these innovations can help decrease negative aspects of global health education such as its environmental impact.
| S-EPMC8641357 | biostudies-literature
Project description:Introduction: The main challenge of modern hospitals is purchasing medical technologies. Hospital-based health technology assessments (HB-HTAs) are used in healthcare facilities around the world to support management boards in providing relevant technologies for patients. Aim: This study was undertaken to update the existing body of knowledge on the characteristics of HB-HTA systems/models in the selected European countries. Insights gained from this study were used to provide an optimal approach for implementing HB-HTA in Poland. Materials and methods: Firstly, we carried out a systematic review in PubMed and embase. Secondly, we searched for gray literature via the AdHopHTA online handbook and the design book of the AdHopHTA project, as well as literature describing healthcare systems provided by the WHO. Then, we conducted in-depth interviews with HB-HTA experts from four countries. Finally, we selected ten countries from Europe and prepared frameworks for data collection and analyses. Results: The selected countries (Switzerland, Spain, France, Italy, Denmark, Finland, Sweden, the Netherlands, and Austria) are examples of decentralized or deconcentrated healthcare systems. In terms of HB-HTA, differences in organisational models (independent group, stand-alone, integrated-essential, integrated-specialised), type of financing (internally vs. externally), collaboration with an HTA National Agency and other stakeholders (e.g., Patients' Associations) were identified. HB-HTA engages multi-skilled staff with various academic backgrounds and operates mainly on a voluntary basis. Conclusion: Strengths and weaknesses associated with various organisational models must be carefully considered in the context of support for decentralized or centralized models of implementation while embarking on HTA activities in Polish hospitals.
| S-EPMC8155722 | biostudies-literature
Project description:BackgroundThe Ankylosing Spondylitis Association of Switzerland (SVMB) aimed to implement physical activity recommendations (PAR) within their exercise groups (EGs). The PAR promote exercise in all fitness dimensions at the correct dose. To implement the PAR within EGs, they were translated into a new EG concept with five key activities: (a) training for supervising physiotherapists (PTs), (b) correctly dosed exercises in all fitness dimensions, (c) exercise counselling, (d) bi-annual fitness assessments, and (e) individual exercise training, in addition to EG. All these activities were realized in close coordination with SVMB management.ObjectivesTo analyse the implementation success by evaluating adherence/fidelity, feasibility, and satisfaction at the patient, PTs, and organisational level.MethodsThe five key activities of the new EG concept were developed, executed, and assessed after 6 months. The primary outcomes for implementation success were adherence of patients to the recommended exercise behaviour, self-reported by electronic diary; fidelity of PTs to the new concept, self-reported by diary; SVMB organisational changes. Secondary outcomes were feasibility and satisfaction with the new EG concept at all three levels. The tertiary outcome, to evaluate the effectiveness of PAR, was patient fitness, assessed through fitness assessments.Results30 patients with axSpA (ten women, mean age 58 ± 9 years) and four PTs (three women, mean age 46 ± 9 years) participated. The patients' self-reporting of adherence to the PAR was insufficient (43%), possibly due to technical problems with the electronic dairy. The PTs' fidelity to the new EG concept was satisfactory. On all levels, the new concept was generally perceived as feasible and useful for supporting personalised exercise.The frequency of exercise counselling and the fitness assessments was found by patients and PTs to be too high and rigid. Patients' cardiorespiratory fitness [ES 1.21 (95%CI 0.59, 1.89)] and core strength [ES 0.61 (95%CI 0.18, 1.06)] improved over the 6 months.ConclusionsThe pilot implementation of PAR showed acceptance and satisfaction to be sufficient, thus confirming the need for evidence-based EGs, provided by a patient organisation in order to support active PA behaviour. However, adaptations are necessary to increase its feasibility for nationwide implementation.Trial registrationSNCTP, SNCTP000002880. Registered 31 May 2018, https://www.kofam.ch/en/snctp-portal/search/0/study/42491 .
| S-EPMC8762948 | biostudies-literature
Project description:Serological surveillance for vaccine-preventable diseases, such as measles and rubella, can provide direct measures of population immunity across age groups, identify gaps in immunity, and document changes in immunity over time. Rigorously conducted, representative household serosurveys provide high-quality estimates with minimal bias. However, they can be logistically challenging, expensive, and have higher refusal rates than vaccine coverage surveys. This article shares lessons learned through implementing nine measles and rubella household serosurveys in five districts in India-the challenges faced, the potential impact on results, and recommendations to facilitate the conduct of serosurveys. Specific lessons learned arose from challenges related to community mobilization owing to lack of cooperation in certain settings and populations, limitations of outdated census information, nonresponse due to refusal or unavailability during survey enumeration and enrollment, data collection issues, and specimen collection and handling issues. Although some experiences are specific to serosurveys in India, these lessons are generalizable to other household surveys, particularly vaccination coverage and serosurveys conducted in low- and middle-income settings.
| S-EPMC8641364 | biostudies-literature
Project description:Background:With the uncertainties of COVID-19, people infected with coronavirus present with diverse psychiatric presentations. Some institutions have had to manage their patients with existing protocols, others have had to create them. In this article we aimed to report the challenges and good practices in the management of psychiatric conditions and delirium coexisting with COVID-19 across continents. Methods:Early Career Psychiatrists (ECPs) from across five continents were approached to share their experiences on the management of psychiatric conditions in patients with COVID-19 during the current pandemic. Results:We collected information about the experiences from sixteen countries. Commonalities were similar psychiatric presentations and poor preparedness across countries. Differences were varying adjustments made in the management of psychiatric conditions coexisting with COVID-19 and different innovations. Good practices which can be adopted by other countries are novel approaches such as telepsychiatry, proactive consultation-liaison units and enhanced community services targeted at circumventing challenges faced when providing mental health services. Conclusions:These findings highlight the need for global preparedness in the mental health sector during outbreaks of infectious diseases, and the need for concerted efforts targeted at global and locally sensitive adaptation of existing protocols and the development of new guidelines for the management of psychiatric conditions for the present pandemic and subsequent occurrences.
| S-EPMC7501517 | biostudies-literature
Project description:PURPOSE:Incorporating a patient's genotype into the clinical decision-making process is one approach to precision medicine. The University of Florida (UF) Health Precision Medicine Program is a pharmacist-led multidisciplinary effort that has led the clinical implementation of six gene-drug(s) pairs to date. This study focuses on the challenges encountered and lessons learned with implementing pharmacogenetic testing for three of these: CYP2D6-opioids, CYP2D6/CYP2C19-selective serotonin reuptake inhibitors, and CYP2C19-proton pump inhibitors within six pragmatic clinical trials at UF Health and partners. METHODS:We compared common measures collected within each of the pharmacogenetic implementations as well as solicited feedback from stakeholders to identify challenges, successes, and lessons learned. RESULTS:We identified several challenges related to trial design and implementation, and learned valuable lessons. Most notably, case discussions are effective for prescriber education, prescribers need clear concise guidance on genotype-based actions, having genotype results available at the time of the patient-prescriber encounter helps optimize the ability to act on them, children prefer noninvasive sample collection, and study participants are willing to answer patient-reported outcomes questionnaires if they are not overly burdensome, among others. CONCLUSION:The lessons learned from implementing three gene-drug pairs in ambulatory care settings will help shape future pharmacogenetic clinical trials and clinical implementations.
| S-EPMC6768772 | biostudies-literature