Case study: lessons learned through digitizing the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Collection.
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ABSTRACT:
SUBMITTER: Hatfield AJ
PROVIDER: S-EPMC1924953 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Pharmacists are vital health care providers to patients with heart failure (HF), but their compliance to the HF core measure has not been clearly defined.The objective of this study was to measure the impact of pharmacist involvement at discharge on compliance with The Joint Commission HF core measure.This prospective study was conducted at a 361-bed academic teaching institution. A pharmacist performed chart reviews just prior to discharge on adult patients with a preliminary diagnosis of HF (ie, clinical suspicion) to evaluate compliance with the HF core measure. The pharmacist then intervened as needed to ensure compliance. The primary outcome was HF core measure compliance rates with pharmacist involvement at discharge compared to rates during the same 3-month period during the previous year (without pharmacist involvement).Of 92 patients admitted with clinical suspicion of HF, the pharmacist was able to review 45 patient charts at discharge (49%). The majority of interventions made by the pharmacist were due to medication discrepancies within the discharge instructions found during medication reconciliation. Rates of compliance with the HF core measure did not differ between the period with pharmacist involvement at discharge and the previous period (without pharmacist involvement, P = .39). However, barriers to compliance related to discharge medication documentation, interdisciplinary communication, and manpower were identified through the process.Although pharmacist involvement at discharge did not translate into improved compliance with the HF core measure, systematic barriers to compliance were identified and are currently being addressed.
| S-EPMC4319801 | biostudies-other
Project description:BackgroundType 2 diabetes mellitus is preventable through lifestyle intervention. Diabetes prevention programmes (DPPs) aim to deliver prevention-based behaviour change interventions to reduce incidence. Such programmes vary from usual primary care in terms of where, how, and by whom they are delivered. Implementation is therefore likely to face new commissioning, incentive and delivery challenges. We report on the implementation of a national DPP in NHS England, and identify lessons learned in addressing the implementation challenges.MethodsIn 2017/18, we conducted 20 semi-structured telephone interviews covering 16 sampled case sites with the designated lead(s) responsible for local implementation of the programme. Interviews explored the process of implementation, including organisation of the programme, expectations and attitudes to the programme, funding, target populations and referral and clinical pathways. We drew on constant comparative methods to analyse the data and generate over-arching themes. We complemented our qualitative data with a survey focused on variation in the financial incentives used across sites to ensure usual primary care services recruited patients to new providers.ResultsWe identified five over-arching areas of learning for implementing this large-scale programme: 1) managing new providers; 2) promoting awareness of services; 3) recruiting patients; 4) incentive payments; and 5) mechanisms for sharing learning. In general, tensions appeared to be caused by a lack of clear roles/responsibilities between hierarchical actors, and lack of communication. Both local sites and the national NHS coordination team gained experience through learning by doing. Initial tensions with roles and expectations have been worked out during implementation.ConclusionsImplementing a national disease prevention programme is a major task, and one that will be increasingly faced by health systems globally as they aim to adjust to demand pressures. We provide practical learning opportunities for the wider uptake and sustainability of prevention programmes. Future implementers might wish to define clear responsibilities for each actor prior to implementation, ensure early engagement with new providers, offer mechanisms/forums for sharing learning, generate evidence and provide advice on incentive payments, and prioritise public and professional awareness of the programme.
| S-EPMC6929377 | biostudies-literature
Project description:PurposeTo increase access of underserved/health disparities communities to National Cancer Institute (NCI) clinical trials, the Radiation Research Program piloted a unique model - the Cancer Disparities Research Partnership (CDRP) program. CDRP targeted community hospitals with a limited past NCI funding history and provided funding to establish the infrastructure for their clinical research program.MethodsInitially, 5-year planning phase funding was awarded to six CDRP institutions through a cooperative agreement (U56). Five were subsequently eligible to compete for 5-year implementation phase (U54) funding and three received a second award. Additionally, the NCI Center to Reduce Cancer Health Disparities supported their U56 patient navigation programs.ResultsCommunity-based hospitals with little or no clinical trials experience required at least a year to develop the infrastructure and establish community outreach/education and patient navigation programs before accrual to clinical trials could begin. Once established, CDRP sites increased their yearly patient accrual mainly to NCI-sponsored cooperative group trials (~60%) and Principal Investigator/mentor-initiated trials (~30%). The total number of patients accrued on all types of trials was 2,371, while 5,147 patients received navigation services.ConclusionDespite a historical gap in participation in clinical cancer research, underserved communities are willing/eager to participate. Since a limited number of cooperative group trials address locally advanced diseases seen in health disparities populations; this shortcoming needs to be rectified. Sustainability for these programs remains a challenge. Addressing these gaps through research and public health mechanisms may have an important impact on their health, scientific progress, and efforts to increase diversity in NCI clinical trials.
| S-EPMC4217306 | biostudies-literature
Project description:OBJECTIVE:To describe lessons learned from the use of different strategies for recruiting physicians responsible for trauma triage, we summarize recruitment data from four behavioral trials run in the United States between 2010 and 2016. RESULTS:We ran a series of behavioral trials with the primary objective of understanding the influence of heuristics on physician decision making in trauma triage. Three studies were observational; one tested an intervention. The trials used different methods of recruitment (in-person vs. email), timing of the honorarium (pre-paid vs. conditional on completion), type of honorarium [a $100 gift card (monetary reward) vs. an iPad mini 2 (material incentive)], and study tasks (a vignette-based questionnaire, virtual simulation, and intervention plus virtual simulation). We recruited 989 physicians, asking each to complete a questionnaire or virtual simulation online. Recruitment and response rates were 80% in the study where we approached physicians in person, used a pre-paid material incentive, and required that they complete both an intervention plus a virtual simulation. They were 56% when we recruited physicians via email, used a monetary incentive conditional on completion of the task, and required that they complete a vignette-based questionnaire. Trial registration clinicaltrials.gov; NCT02857348.
| S-EPMC5745997 | biostudies-literature
Project description:BackgroundMany large-scale cardiovascular clinical trials are plagued with escalating costs and low enrollment. Implementing a computable phenotype, which is a set of executable algorithms, to identify a group of clinical characteristics derivable from electronic health records or administrative claims records, is essential to successful recruitment in large-scale pragmatic clinical trials. This methods paper provides an overview of the development and implementation of a computable phenotype in ADAPTABLE (Aspirin Dosing: a Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness)-a pragmatic, randomized, open-label clinical trial testing the optimal dose of aspirin for secondary prevention of atherosclerotic cardiovascular disease events.Methods and resultsA multidisciplinary team developed and tested the computable phenotype to identify adults ≥18 years of age with a history of atherosclerotic cardiovascular disease without safety concerns around using aspirin and meeting trial eligibility criteria. Using the computable phenotype, investigators identified over 650 000 potentially eligible patients from the 40 participating sites from Patient-Centered Outcomes Research Network-a network of Clinical Data Research Networks, Patient-Powered Research Networks, and Health Plan Research Networks. Leveraging diverse recruitment methods, sites enrolled 15 076 participants from April 2016 to June 2019. During the process of developing and implementing the ADAPTABLE computable phenotype, several key lessons were learned. The accuracy and utility of a computable phenotype are dependent on the quality of the source data, which can be variable even with a common data model. Local validation and modification were required based on site factors, such as recruitment strategies, data quality, and local coding patterns. Sustained collaboration among a diverse team of researchers is needed during computable phenotype development and implementation.ConclusionsThe ADAPTABLE computable phenotype served as an efficient method to recruit patients in a multisite pragmatic clinical trial. This process of development and implementation will be informative for future large-scale, pragmatic clinical trials. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02697916.
| S-EPMC7321832 | biostudies-literature
Project description:Since its start in 1998, Software Carpentry has evolved from a week-long training course at the US national laboratories into a worldwide volunteer effort to improve researchers' computing skills. This paper explains what we have learned along the way, the challenges we now face, and our plans for the future.
| S-EPMC3976103 | biostudies-literature
Project description:Adolescent depression is common; however, over 60% of depressed adolescents do not receive mental health care. Digitally-delivered evidence-based psychosocial interventions (EBPIs) may provide an opportunity to improve access and engagement in mental health care. We present a case study that reviews lessons learned from using the Discover - Design - Build - Test (DDBT) model to create, develop, and evaluate a high-fidelity prototype of an app to deliver an EBPI for depression, behavioral activation (BA), on an Asynchronous Remote Communities (ARC) platform (referred to as ActivaTeen). We review work at each stage of the DDBT framework, including initial formative work, iterative design and development work, and an initial feasibility study. We engaged teens with depression, mental health clinicians, and expert evaluators through the process. We found that the DDBT model supported the research team in understanding the requirements for our prototype system, ActivaTeen, and conceiving of and developing specific ideas for implementation. Our work contributes a case study of how the DDBT framework can be applied to adapting an EBPI to a new, scalable and digital format. We provide lessons learned from engaging teens and clinicians with an asynchronous approach to EBPIs and human centered design considerations for teen mental health.
| S-EPMC8983010 | biostudies-literature
Project description:Substantial information regarding the role of lung volume reduction surgery (LVRS) in severe emphysema emanates from the National Emphysema Treatment Trial (NETT). The NETT was not a crossover trial and therefore was able to examine the effects of optimal medical management and LVRS on short- and long-term survival,as well as lung function, exercise performance, and quality of life.The NETT generated multiple insights into the preoperative, perioperative,and postoperative management of patients undergoing thoracotomy; described pain control techniques that were safe and effective; and emphasized the need to address nonpulmonary issues to optimize surgical outcomes. After the NETT, newer investigation has focused on bronchoscopic endobronchial interventions and other techniques less invasive than LVRS to achieve lung reduction.In this review, we summarize what we currently know about the role of LVRS in the treatment of severe emphysema as a result of insights gained from the NETT and provide a brief review of the newer techniques of lung volume reduction.
| S-EPMC3208657 | biostudies-literature
Project description:Objective and methodsWorldwide, tuberculosis (TB) is the leading cause of death from a single infectious agent. In many countries, national TB prevalence surveys are the only way to reliably measure the burden of TB disease and can also provide other evidence to inform national efforts to improve TB detection and treatment. Our objective was to synthesise the results and lessons learned from national surveys completed in Africa between 2008 and 2016, to complement a previous review for Asia.ResultsTwelve surveys completed in Africa were identified: Ethiopia (2010-2011), Gambia (2011-2013), Ghana (2013), Kenya (2015-2016), Malawi (2013-2014), Nigeria (2012), Rwanda (2012), Sudan (2013-2014), Tanzania (2011-2012), Uganda (2014-2015), Zambia (2013-2014) and Zimbabwe (2014). The eligible population in all surveys was people aged ≥15 years who met residency criteria. In total 588 105 individuals participated, equivalent to 82% (range 57-96%) of those eligible. The prevalence of bacteriologically confirmed pulmonary TB disease in those ≥15 years varied from 119 (95% CI 79-160) per 100 000 population in Rwanda and 638 (95% CI 502-774) per 100 000 population in Zambia. The male:female ratio was 2.0 overall, ranging from 1.2 (Ethiopia) to 4.1 (Uganda). Prevalence per 100 000 population generally increased with age, but the absolute number of cases was usually highest among those aged 35-44 years. Of identified TB cases, 44% (95% CI 40-49) did not report TB symptoms during screening and were only identified as eligible for diagnostic testing due to an abnormal chest X-ray. The overall ratio of prevalence to case notifications was 2.5 (95% CI 1.8-3.2) and was consistently higher for men than women. Many participants who did report TB symptoms had not sought care; those that had were more likely to seek care in a public health facility. HIV prevalence was systematically lower among prevalent cases than officially notified TB patients with an overall ratio of 0.5 (95% CI 0.3-0.7). The two main study limitations were that none of the surveys included people <15 years, and 5 of 12 surveys did not have data on HIV status.ConclusionsNational TB prevalence surveys implemented in Africa between 2010 and 2016 have contributed substantial new evidence about the burden of TB disease, its distribution by age and sex, and gaps in TB detection and treatment. Policies and practices to improve access to health services and reduce under-reporting of detected TB cases are needed, especially among men. All surveys provide a valuable baseline for future assessment of trends in TB disease burden.
| S-EPMC8043149 | biostudies-literature
Project description:Background:Women enrolled in human immunodeficiency virus (HIV) prevention efficacy trials receive counseling on prevention of HIV, sexually transmitted infections (STIs), and pregnancy during every visit. Incident pregnancy has an impact on efficacy outcomes. Incidence rates of pregnancy and HIV/STIs among women who became pregnant and associated risk factors were assessed. Methods:Data from 9165 women participating in HIV prevention trials in KwaZulu-Natal, South Africa from 2002-2012 were combined. Demographic and behavioral predictors of incidence pregnancy and incidence HIV and STIs were determined using Cox regression models. Results:Overall pregnancy incidence was 9.6 per 100 person-year (py) (95% confidence interval [Cl], 9.1-10.3). Human immunodeficiency virus incidence among pregnant women was 5.93 per 100 py (95% Cl, 4.73-7.44). Incidence of STIs among pregnant women for Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae, and Treponema pallidum (syphilis) were 10.87, 7.42, 3.92, and 1.43 per 100 py, respectively. In the adjusted analyses, we observed overlapping risk factors for HIV acquisition during pregnancy, ie, young age, not married/not cohabitating, and low parity. The risk of pregnancy and HIV acquisition is more than 3 times higher among young women (<20 years of age). Conclusions:We identified overlapping risk factors for pregnancy and HIV incidence, suggesting an urgent need for appropriate, targeted, individual-centred counseling for women participating in HIV prevention trials.
| S-EPMC7191892 | biostudies-literature