Implementing Serosurveys in India: Experiences, Lessons Learned, and Recommendations.
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SUBMITTER: Hasan AZ
PROVIDER: S-EPMC8641364 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Although traditional methods of data collection in naturalistic settings can shed light on constructs of interest to researchers, advances in sensor-based technology allow researchers to capture continuous physiological and behavioral data to provide a more comprehensive understanding of the constructs that are examined in a dynamic health care setting. This study gives examples for implementing technology-facilitated approaches and provides the following recommendations for conducting such longitudinal, sensor-based research, with both environmental and wearable sensors in a health care setting: pilot test sensors and software early and often; build trust with key stakeholders and with potential participants who may be wary of sensor-based data collection and concerned about privacy; generate excitement for novel, new technology during recruitment; monitor incoming sensor data to troubleshoot sensor issues; and consider the logistical constraints of sensor-based research. The study describes how these recommendations were successfully implemented by providing examples from a large-scale, longitudinal, sensor-based study of hospital employees at a large hospital in California. The knowledge gained from this study may be helpful to researchers interested in obtaining dynamic, longitudinal sensor data from both wearable and environmental sensors in a health care setting (eg, a hospital) to obtain a more comprehensive understanding of constructs of interest in an ecologically valid, secure, and efficient way.
| S-EPMC6930504 | biostudies-literature
Project description:BackgroundThe WHO Safe Childbirth Checklist (SCC) contains 29 evidence-based practices (EBPs) across four pause points spanning admission to discharge. It has been shown to increase EBP uptake and has been tailored to specific contexts. However, little research has been conducted in East Africa on use of the SCC to improve intrapartum care, particularly for preterm birth despite its burden. We describe checklist adaptation, user acceptability, implementation and lessons learned.MethodsThe East Africa Preterm Birth Initiative (PTBi EA) modified the SCC for use in 23 facilities in Western Kenya and Eastern Uganda as part of a cluster randomized controlled trial evaluating a package of facility-based interventions to improve preterm birth outcomes. The modified SCC (mSCC) for prematurity included: addition of a triage pause point before admission; focus on gestational age assessment, identification and management of preterm labour; and alignment with national guidelines. Following introduction, implementation lasted 24 and 34 months in Uganda and Kenya respectively and was supported through complementary mentoring and data strengthening at all sites. PRONTO® simulation training and quality improvement (QI) activities further supported mSCC use at intervention facilities only. A mixed methods approach, including checklist monitoring, provider surveys and in-depth interviews, was used in this analysis.ResultsA total of 19,443 and 2229 checklists were assessed in Kenya and Uganda, respectively. In both countries, triage and admission pause points had the highest rates of completion. Kenya's completion was greater than 70% for all pause points; Uganda ranged from 39 to 75%. Intervention facilities exposed to PRONTO and QI had higher completion rates than control sites. Provider perceptions cited clinical utility of the checklist, particularly when integrated into patient charts. However, some felt it repeated information in other documentation tools. Completion was hindered by workload and staffing issues.ConclusionThis study highlights the feasibility and importance of adaptation, iterative modification and complementary activities to reinforce SCC use. There are important opportunities to improve its clinical utility by the addition of prompts specific to the needs of different contexts. The trial assessing the PTBi EA intervention package was registered at ClinicalTrials.gov NCT03112018 Registered December 2016, retrospectively registered.
| S-EPMC8896298 | biostudies-literature
Project description:PurposeInvestigational and marketed vaccines are increasingly evaluated, and manufacturers are required to put in place mechanisms to monitor long-term benefit-risk profiles. However, generating such evidence in real-world settings remains challenging, especially when rare adverse events are assessed. Planning of an appropriate study design is key to conducting a valid study. The aim of this paper is to illustrate how feasibility assessments support the generation of robust pharmacoepidemiological data.MethodsFollowing an initiative launched by the International Society for Pharmacoepidemiology in May 2014, a working group including members of the private and public sectors, was formed to assess the value of conducting feasibility assessments as a necessary step before embarking on larger-scale post-licensure studies. Based on five real-life examples of feasibility assessments, lessons learned and recommendations were issued by the working group to support scientific reasoning and decision making when designing pharmacoepidemiologic vaccine studies.ResultsThe working group developed a toolbox to provide a pragmatic approach to conducting feasibility assessments. The toolbox contains two main components: the scientific feasibility and the operational feasibility. Both components comprise a series of specific questions aimed at overcoming methodological and operational challenges.ConclusionsA feasibility assessment should be formalized as a necessary step prior to the actual start of any pharmacoepidemiologic study. It should remain a technical evaluation and not a hypothesis testing. The feasibility assessment report may facilitate communication with regulatory agencies toward improving the quality of study protocols and supporting the endorsement of study objectives and methods addressing regulatory commitments. © 2016 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.
| S-EPMC5157751 | biostudies-literature
Project description:BackgroundChronic disease management models of care provide an opportunity to assist home care clients to manage their disease burden. However, pragmatic trial management practices and lessons learned from such models are poorly illustrated in the literature.MethodsWe describe the processes of implementing a community-based cardiorespiratory self-management model, known as DIVERT-CARE, across the home care programs of three health regions in Canada. The DIVERT-CARE model is a multi-component complex intervention that identifies home care clients at the highest risk of deterioration and provides them with resources and capacity to manage their conditions. We conducted a retrospective analysis of baseline participant characteristics, needs assessments, reviewed findings from site visits and a national workshop with study partners, and examined other study documentation.ResultsThree home care regions in Canada participated in the study. A robust and data-driven review of each site was necessary to understand the local context, home care caseloads, structure of local systems, and intensity of resources, which influenced study processes. The creation of an intervention framework highlighted the need to adapt the intervention in a way that was sensitive to the local context while maintaining intervention outcomes.ConclusionOur detailed review showcases the relevant activities and on-the-ground steps needed to manage and conduct a multi-site pragmatic trial in home care. This example can help other researchers in implementing multi-disciplinary and multi-component care models for practice-based research.
| S-EPMC8111935 | biostudies-literature
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:BackgroundExcessive inpatient administrative tasks can lead to adverse consequences for residents and their patients. Furthermore, this burden has been linked to depersonalization, a major component of physician burnout.ObjectiveTo describe the development, implementation, feasibility, acceptability, and early outcomes of Resident Team Assistant (RTA) programs.MethodsThree large academic medical centers created RTA programs in which administrative assistants are incorporated into inpatient medical teams. First steps included a needs assessment and driver diagram creation to identify key issues and to solidify goals. Program directors were assigned, and RTAs were hired, trained, and incorporated into inpatient teams at each institution (2003, 2016, 2018). Program leadership and institutional stakeholders met regularly to discuss development and quality assurance. Surveys and direct interviews were performed to evaluate impact and acceptability. Institutional goals in accordance to RTAs tasks were also investigated.ResultsResident surveys and interviews have shown acceptability with RTAs completing a large percentage of resident administrative tasks while promoting time spent in direct clinical care and job satisfaction. Hospital-specific improvements have included increase in referring physician communication rate and decrease in work hour violations. The programs have maintained high feasibility and sustainability with a relatively low time commitment from leadership and cost for the institutions.ConclusionsThe RTA programs at the 3 institutions have continued to be sustained over time with perceived improvements in administrative task burden and job satisfaction for the residents. They have maintained high acceptability and feasibility in terms of effort and costs for the hospitals.
| S-EPMC7771612 | biostudies-literature
Project description:BackgroundDrug overdose has become a leading cause of accidental death in the United States. Between 2000 and 2015, the rate of deaths from drug overdoses increased 137%, including a 200% increase in the rate of overdose deaths involving opioids (including opioid pain relievers and heroin). Unnecessary opioid prescribing is one of the factors driving this epidemic.ObjectivesThe primary objective of this paper is to share lessons learned while conducting a randomized trial to de-implement opioids for post-extraction pain management utilizing clinical decision support (CDS) with and without patient education. The lessons learned from conducting this trial in a real-world setting can be applied to future dissemination and implementation oral health research.MethodsThe sources informing lessons learned were generated from qualitative interviews conducted with 20 of the forty-nine dental providers involved in the study following the implementation phase of the trial. Ongoing policy, social and environmental factors were tracked throughout the study.ResultsDental providers in the trial identified the impact of training that involved health professionals sharing information about the personal impact of pain and opioid use. Additionally, they found utility in being presented with a dashboard detailing their prescribing patterns related to other dentists. For the 30 general dentists with access to the CDS, use of its portal varied widely, with most using it 10%-49% of the time related to extractions.ConclusionsIn the context of a downward trend in opioid prescribing and considering the influence of the COVID pandemic during the trial, dental providers indicated benefit in training about negative personal impacts of prescribing opioids, and personally relevant feedback about their prescribing patterns. Only modest use of the CDS was realized. Implementation of this trial was impacted by governmental and health system policies and the COVID pandemic, prompt the consideration of implications regarding continuing ways to limit opioid prescribing among dental providers.
| S-EPMC9993482 | 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:BackgroundIn spite of considerable improvement in maternal and neonatal outcomes over the past decade in India, the current maternal mortality ratio and neonatal mortality rate are far from the Sustainable Development Goal targets due to suboptimal quality of maternity care. A package of interventions for improving quality of intrapartum and immediate postpartum care was co-designed with the Ministry of Health as the Dakshata program and implemented in public sector health facilities in selected districts in the state of Rajasthan of India since June 2015. This article describes the key strategies, interventions, results and challenges from four years of Dakshata program implementation.MethodsWe have conducted secondary analysis of program data (government data) collected from 202 public facilities across 20 districts of Rajasthan state. The data collected between June-August 2015 (baseline) and the data collected between May-August 2019 (latest) were analyzed. The data sources included: facility assessments, service statistics, monthly progress reports.ResultsDuring the period of program implementation, there were 17,94,249 deliveries accounting for 70% of institutional deliveries in intervention districts. As a result of the intervention, there was a notable increase in competency of health care providers, availability of essential resources, achievement of labour room standards and adherence to evidence-based clinical standards. We also observed reductions in the proportion of referrals for pre-eclampsia/eclampsia, postpartum hemorrhage and neonatal asphyxia by 11, 8 and 3 percentage points respectively. Similarly, data revealed a reduction in stillbirth rates in Dakshata intervention facilities (19.3 vs 15.3) compared to non-Dakshata facilities (21.8 vs 18).ConclusionsOur experience and findings indicate that the quality of intrapartum and immediate postpartum care can be improved in low- and middle-income countries with the approach presented in this paper.
| S-EPMC9308226 | biostudies-literature
Project description:BACKGROUND:Falls lead to a disproportionate burden of death and disability among older adults despite evidence-based recommendations to screen regularly for fall risk and clinical trials demonstrating the effectiveness of multifactorial interventions to reduce falls. The Centers for Disease Control and Prevention developed STEADI (Stopping Elderly Accidents, Deaths, and Injuries) to assist primary care teams to screen for fall risk and reduce risk of falling in older adults. PURPOSE OF THE STUDY:This paper describes a practical application of STEADI in a large academic internal medicine clinic utilizing the Kotter framework, a tool used to guide clinical practice change. DESIGN AND METHODS:We describe key steps and decision points in the implementation of STEADI as they relate to the recommended strategies of the Kotter framework. Strategies include: creating a sense of urgency, building a guiding coalition, forming a strategic vision and initiative, enlisting volunteers, enabling success by removing barriers, generating short-term wins, sustaining change, and instituting change. RESULTS:Fifty-six patients were screened during pilot testing; 360 patients were screened during the first 3 months of implementation. Key to successful implementation was (a) the development of electronic health record (EHR) tools and workflow to guide clinical practice and (b) the proactive leadership of clinical champions within the practice to identify and respond to barriers. IMPLICATIONS:Implementing falls prevention in a clinical setting required support and effort across multiple stakeholders. We highlight challenges, successes, and lessons learned that offer guidance for other clinical practices in their falls prevention efforts.
| S-EPMC5940581 | biostudies-literature