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1.
JMIR Med Inform ; 12: e49785, 2024 Jun 25.
Artigo em Inglês | MEDLINE | ID: mdl-38917448

RESUMO

BACKGROUND: Self-administered web-based questionnaires are widely used to collect health data from patients and clinical research participants. REDCap (Research Electronic Data Capture; Vanderbilt University) is a global, secure web application for building and managing electronic data capture. Unfortunately, stakeholder needs and preferences of electronic data collection via REDCap have rarely been studied. OBJECTIVE: This study aims to survey REDCap researchers and administrators to assess their experience with REDCap, especially their perspectives on the advantages, challenges, and suggestions for the enhancement of REDCap as a data collection tool. METHODS: We conducted a web-based survey with representatives of REDCap member organizations in the United States. The survey captured information on respondent demographics, quality of patient-reported data collected via REDCap, patient experience of data collection with REDCap, and open-ended questions focusing on the advantages, challenges, and suggestions to enhance REDCap's data collection experience. Descriptive and inferential analysis measures were used to analyze quantitative data. Thematic analysis was used to analyze open-ended responses focusing on the advantages, disadvantages, and enhancements in data collection experience. RESULTS: A total of 207 respondents completed the survey. Respondents strongly agreed or agreed that the data collected via REDCap are accurate (188/207, 90.8%), reliable (182/207, 87.9%), and complete (166/207, 80.2%). More than half of respondents strongly agreed or agreed that patients find REDCap easy to use (165/207, 79.7%), could successfully complete tasks without help (151/207, 72.9%), and could do so in a timely manner (163/207, 78.7%). Thematic analysis of open-ended responses yielded 8 major themes: survey development, user experience, survey distribution, survey results, training and support, technology, security, and platform features. The user experience category included more than half of the advantage codes (307/594, 51.7% of codes); meanwhile, respondents reported higher challenges in survey development (169/516, 32.8% of codes), also suggesting the highest enhancement suggestions for the category (162/439, 36.9% of codes). CONCLUSIONS: Respondents indicated that REDCap is a valued, low-cost, secure resource for clinical research data collection. REDCap's data collection experience was generally positive among clinical research and care staff members and patients. However, with the advancements in data collection technologies and the availability of modern, intuitive, and mobile-friendly data collection interfaces, there is a critical opportunity to enhance the REDCap experience to meet the needs of researchers and patients.

2.
Health Informatics J ; 30(2): 14604582241249927, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38717450

RESUMO

A public health registry and intervention was created in response to the Flint water crisis to identify and refer exposed individuals to public health services to ameliorate the deleterious impact of lead exposure. Traditional technology architecture domains, funded scope of work, as well as community input were considered when defining the requirements of the selected solutions. A hybrid software solution was created using Research Electronic Data Capture (REDCap) to deploy an open participant survey and bypass requirements to create user accounts, and Epic to manage deduplication and participant communication and tracking. To bridge the two software systems, REDCap to Epic unidirectional ADT and Documentation Flowsheet interfaces were built to automate creation of subject records in Epic identical to those created in REDCap and to copy key protocol-driving variables from REDCap to Epic. The interfaces were critical to deliver a successful hybrid solution in which the desired features of each software could be leveraged to satisfy specific protocol requirements and community input. Data from the start of survey administration (December 2018) through 31 December 2020 are reported to demonstrate the usefulness of the interfaces.


Assuntos
Saúde Pública , Sistema de Registros , Software , Humanos , Sistema de Registros/estatística & dados numéricos , Saúde Pública/métodos , Registros Eletrônicos de Saúde , Interface Usuário-Computador , Inquéritos e Questionários
3.
Sensors (Basel) ; 24(8)2024 Apr 14.
Artigo em Inglês | MEDLINE | ID: mdl-38676127

RESUMO

The Internet of Things (IoT) will bring about the next industrial revolution in Industry 4.0. The communication aspect of IoT devices is one of the most critical factors in choosing the device that is suitable for use. Thus far, the IoT physical layer communication challenges have been met with various communications protocols that provide varying strengths and weaknesses. This paper summarizes the network architectures of some of the most popular IoT wireless communications protocols. It also presents a comparative analysis of some of the critical features, including power consumption, coverage, data rate, security, cost, and quality of service (QoS). This comparative study shows that low-power wide area network (LPWAN)-based IoT protocols (LoRa, Sigfox, NB-IoT, LTE-M) are more suitable for future industrial applications because of their energy efficiency, high coverage, and cost efficiency. In addition, the study also presents an Industrial Internet of Things (IIoT) application perspective on the suitability of LPWAN protocols in a particular scenario and addresses some open issues that need to be researched. Thus, this study can assist in deciding the most suitable IoT communication protocol for an industrial and production field.

4.
JMIR Form Res ; 8: e50897, 2024 Apr 16.
Artigo em Inglês | MEDLINE | ID: mdl-38625736

RESUMO

BACKGROUND: The COVID-19 pandemic brought challenges requiring timely health data sharing to inform accurate decision-making at national levels. In Botswana, we adapted and integrated the Research Electronic Data Capture (REDCap) and the District Health Information System version 2 (DHIS2) platforms to support timely collection and reporting of COVID-19 cases. We focused on establishing an effective COVID-19 data flow at the national public health laboratory, being guided by the needs of health care professionals at the National Health Laboratory (NHL). This integration contributed to automated centralized reporting of COVID-19 results at the Ministry of Health (MOH). OBJECTIVE: This paper reports the experiences, challenges, and lessons learned while designing, adapting, and implementing the REDCap and DHIS2 platforms to support COVID-19 data management at the NHL in Botswana. METHODS: A participatory design approach was adopted to guide the design, customization, and implementation of the REDCap platform in support of COVID-19 data management at the NHL. Study participants included 29 NHL and 4 MOH personnel, and the study was conducted from March 2, 2020, to June 30, 2020. Participants' requirements for an ideal COVID-19 data management system were established. NVivo 11 software supported thematic analysis of the challenges and resolutions identified during this study. These were categorized according to the 4 themes of infrastructure, capacity development, platform constraints, and interoperability. RESULTS: Overall, REDCap supported the majority of perceived technical and nontechnical requirements for an ideal COVID-19 data management system at the NHL. Although some implementation challenges were identified, each had mitigation strategies such as procurement of mobile Internet routers, engagement of senior management to resolve conflicting policies, continuous REDCap training, and the development of a third-party web application to enhance REDCap's capabilities. Lessons learned informed next steps and further refinement of the REDCap platform. CONCLUSIONS: Implementation of REDCap at the NHL to streamline COVID-19 data collection and integration with the DHIS2 platform was feasible despite the urgency of implementation during the pandemic. By implementing the REDCap platform at the NHL, we demonstrated the possibility of achieving a centralized reporting system of COVID-19 cases, hence enabling timely and informed decision-making at a national level. Challenges faced presented lessons learned to inform sustainable implementation of digital health innovations in Botswana and similar resource-limited countries.

5.
J Audiol Otol ; 2024 Apr 30.
Artigo em Inglês | MEDLINE | ID: mdl-38685833

RESUMO

Background and Objectives: : A cochlear implant (CI) is an effective prosthetic device used to treat severe-to-profound hearing loss. The present study examined cognitive function in CI users by employing a web-based cognitive testing platform, i.e., BrainCheck, and explored the correlation between cognitive function and subjective evaluation of hearing. Subjects and Methods: : Forty-two CI users (mean age: 58.90 years) were surveyed in the subjective evaluation of hearing, and 20/42 participated in the BrainCheck cognitive tests (immediate recognition, Trail Making A, Trail Making B, Stroop, digit symbol substitution, and delayed recognition). As controls for cognitive function, young normal-hearing (YNH, mean age=23.83 years) and older normal-hearing (ONH, mean age=52.67 years) listener groups were subjected to Brain- Check testing. Results: : CI users exhibited poorer cognitive function than the normal hearing groups in all tasks except for immediate and delayed recognition. The highest percentage of CI users who had "possible" and "likely" cognitive impairment, based on BrainCheck scores (ranging from 0-200), was observed in tests assessing executive function. The composite cognitive score across domains tended to be related to subjective hearing (p=0.07). Conclusions: : The findings of the current study suggest that CI users had a higher likelihood of cognitive impairment in the executive function domain than in lower-level domains. BrianCheck online cognitive testing affords a convenient and effective tool to self-evaluate cognitive function in CI users.

6.
Artigo em Inglês | MEDLINE | ID: mdl-38454797

RESUMO

CONTEXT: The mortality rate in thyroid storm (TS) has been reported to be higher than 10%. OBJECTIVE: We aimed to evaluate the effectiveness of the 2016 guidelines for the management of TS proposed by the Japan Thyroid Association and Japan Endocrine Society. DESIGN: Prospective registry-based study through a secure web platform. SETTING: Prospective multicenter registry. PATIENTS AND MEASUREMENTS: Patients with new-onset TS were registered in the Research Electronic Data Capture (REDCap). On day 30 after admission, clinical information and prognosis of each patient were added to the platform. On day 180, the prognosis was described. RESULTS: This study included 110 patients with TS. The median of Acute Physiology and Chronic Health Evaluation (APACHE) II score was 13, higher than the score in the previous nationwide epidemiological study, 10 (p = 0.001). Nonetheless, the mortality rate at day 30 was 5.5%, approximately half compared with 10.7% in the previous nationwide survey. Lower body mass index, shock and lower left ventricular ejection fraction were positively associated with poor prognosis at day 30, while the lack of fever ≥ 38℃ was related to the outcome. The mortality rate in patients with an APACHE II score ≥12 for whom the guidelines were not followed was significantly higher than the rate in patients for whom the guidelines were followed (50% vs. 4.7%) (p = 0.01). CONCLUSIONS: Prognosis seemed better than in the previous nationwide survey, even though disease severity was higher. The mortality rate was lower when the guidelines were followed. Thus, the guidelines are useful for managing TS.

7.
Clin Pediatr (Phila) ; : 99228241237908, 2024 Mar 12.
Artigo em Inglês | MEDLINE | ID: mdl-38469805

RESUMO

The primary objective was to evaluate Group A streptococcal (GAS) tests performed with a Modified Centor Criteria (MCC) Score < 3 at Urgent Care Clinics (UCC). Secondary objectives included evaluating the MCC sensitivity and specificity, antibiotics prescribed with an MCC score < 3, and association between palatal petechiae and GAS pharyngitis infections. This was a retrospective review from July 1, 2018, to June 30, 2019, of Rapid Antigen Detection Tests (RADTs) on patients with ICD codes associated with pharyngitis. Fifteen hundred patient charts were reviewed. The majority of MCC scores were < 3 at 60.0% (878/1464). Sensitivity of GAS testing (RADT/culture) slightly increased for MCC scores ≥ 3 and was better than the specificity of those scores. In comparison, MCC scores < 3, showed better specificity compared to sensitivity. Over 50% of RADTs performed were inappropriate per clinical guidelines. MCC score < 3 had higher rates of negative test results.

8.
BMC Med Res Methodol ; 24(1): 55, 2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-38429658

RESUMO

BACKGROUND: Research Electronic Data CAPture (REDCap) is a web application for creating and managing online surveys and databases. Clinical data management is an essential process before performing any statistical analysis to ensure the quality and reliability of study information. Processing REDCap data in R can be complex and often benefits from automation. While there are several R packages available for specific tasks, none offer an expansive approach to data management. RESULTS: The REDCapDM is an R package for accessing and managing REDCap data. It imports data from REDCap to R using either an API connection or the files in R format exported directly from REDCap. It has several functions for data processing and transformation, and it helps to generate and manage queries to clarify or resolve discrepancies found in the data. CONCLUSION: The REDCapDM package is a valuable tool for data scientists and clinical data managers who use REDCap and R. It assists in tasks such as importing, processing, and quality-checking data from their research studies.


Assuntos
Gerenciamento de Dados , Software , Humanos , Reprodutibilidade dos Testes , Inquéritos e Questionários , Registros
10.
Am J Otolaryngol ; 45(1): 104100, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-37977060

RESUMO

PURPOSE: To describe the creation of a multi-center cochlear implant database as a template for future medical database design. The first clinical question examined was the association between BMI on cochlear implant surgical time and postoperative outcome. MATERIALS AND METHODS: A retrospective repository in REDCap, named the "Repository of Cochlear Implant Information" (ROCII), was created and collected de-identified data on patients who underwent cochlear implantation. Data was exported and stratified into three BMI groupings (<25, 25.0-29.9, ≥ 30.0). Differences in surgical time and AZBio Sentence Test postoperative score changes were analyzed using the mixed-effect model. RESULTS: The mean BMI (n = 145) was 28.52, and the mean surgical time was 128.9 min. The BMI < 25 reference group (n = 50) and the BMI 25.0-29.9 group (n = 50) had an identical mean surgical time of 127.5 min. The BMI ≥30.0 group (n = 45) had a mean surgical time of 132 min, however this difference was not statistically significant when compared to the reference group (p = 0.4727). The mean AZBio postoperative score change (n = 74) was 63.32. The BMI < 25 reference group (n = 29) had a mean postoperative change of 56.66. The BMI 25.0-29.9 group (n = 22) and BMI ≥30.0 group (n = 23) had mean postoperative changes of 61.32 and 73.65 respectively, however these differences were not statistically significant compared to the reference group (p = 0.5847, 0.0637). CONCLUSION: BMI did not have a significant association with surgical time or postoperative outcome and therefore should not be a contraindication for implantation. ROCII will facilitate a deeper understanding of the evaluation process, outcomes, and patient experience of cochlear implantation across institutions. LEVEL OF EVIDENCE: Level 1.


Assuntos
Implante Coclear , Implantes Cocleares , Perda Auditiva Neurossensorial , Percepção da Fala , Humanos , Perda Auditiva Neurossensorial/cirurgia , Estudos Retrospectivos , Resultado do Tratamento , Estudos Multicêntricos como Assunto , Bases de Dados como Assunto
11.
J Arrhythm ; 39(6): 853-859, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-38045445

RESUMO

The Japanese Catheter Ablation (J-AB) registry, started in August 2017, is a voluntary, nationwide, multicenter, prospective, observational registry, performed by the Japanese Heart Rhythm Society (JHRS) in collaboration with the National Cerebral and Cardiovascular Center using a Research Electronic Data Capture system. The purpose of this registry is to collect the details of target arrhythmias, the ablation procedures, including the type of target arrhythmias, outcomes, and acute complications in the real-world settings. During the year of 2021, we have collected a total of 89 609 procedures (mean age of 66.1 years and 65.9% male) from 506 participant hospitals. Detailed data are shown in Figures and Tables.

12.
Biopreserv Biobank ; 2023 Nov 09.
Artigo em Inglês | MEDLINE | ID: mdl-37943607

RESUMO

In Africa, sickle cell disease phenotypes' genetic contributors remain understudied due to the dearth of databases that pair biospecimens with demographic and clinical details. The absence of biorepositories in these settings can exacerbate this issue. This article documents the physical verification process of biospecimens in the biorepository, connecting them to patient clinical and demographic data and aiding in the planning of future genomic and clinical research studies' experience from the Muhimbili Sickle Cell Program in Dar es Salaam, Tanzania. The biospecimen database was updated with the current biospecimen position following the physical verification and then mapping this information to its demographic and clinical data using demographic identifiers. The biorepository stored 74,079 biospecimens in three -80°C freezers, including 63,345 from 5159 patients enrolled in the cohort between 2004 and 2016. Patients were identified by a control (first visit), entry (when confirmed sickle cell homozygous), admission (when hospitalized), and follow-up numbers (subsequent visits). Of 63,345 biospecimens, follow-ups were 46,915 (74.06%), control 8067 (12.74%), admission 5517 (8.71%), and entry 2846 (4.49%). Of these registered patients, females were 2521 (48.87%) and males were 2638 (51.13%). The age distribution was 1-59 years, with those older than 18 years being 577 (11.18%) and children 4582 (88.82%) of registered patients. The notable findings during the process include a lack of automated biospecimen checks, laboratory information management system, and tubes with volume calibration; this caused the verification process to be tedious and manual. Biospecimens not linked to clinical and demographic data, date format inconsistencies, and lack of regular updating of a database on exhausted biospecimens and updates when biospecimens are moved between positions within freezers were other findings that were found. A well-organized biorepository plays a crucial role in answering future research questions. Enforcing standard operating procedures and quality control will ensure that laboratory users adhere to the best biospecimen management procedures.

13.
Digit Threat ; 4(2)2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-37937206

RESUMO

Clinical trials are a multi-billion dollar industry. One of the biggest challenges facing the clinical trial research community is satisfying Part 11 of Title 21 of the Code of Federal Regulations [7] and ISO 27789 [40]. These controls provide audit requirements that guarantee the reliability of the data contained in the electronic records. Context-aware smart devices and wearable IoT devices have become increasingly common in clinical trials. Electronic Data Capture (EDC) and Clinical Data Management Systems (CDMS) do not currently address the new challenges introduced using these devices. The healthcare digital threat landscape is continually evolving, and the prevalence of sensor fusion and wearable devices compounds the growing attack surface. We propose Scrybe, a permissioned blockchain, to store proof of clinical trial data provenance. We illustrate how Scrybe addresses each control and the limitations of the Ethereum-based blockchains. Finally, we provide a proof-of-concept integration with REDCap to show tamper resistance.

14.
MethodsX ; 11: 102454, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37920872

RESUMO

Data quality monitoring plays a crucial role in multicenter prospective registries. By maintaining high data accuracy, completeness, and consistency, researchers can improve the overall quality and reliability of the registry data, enabling meaningful conclusions and supporting evidence-based decisions. The purpose of the present study was to evaluate data quality metrics (completeness, accuracy, and temporal plausibility) of a Multicenter Registry of Cardiac Implantable Electronic Devices (CIEDs) and to perform a direct data audit of a random sample of records to assess the agreement levels with the source documents. The CIED Registry was a prospective, multicenter, real-world observational study carried out from January 2020 to December 2022 in five designated centers across Sao Paulo, Brazil. We assessed the data quality of the CIED Registry by using two distinct approaches:•Dynamic data monitoring using features of the REDCap (Research Electronic Data Capture) software, including data reports and data quality rules•Direct data audit in which information from a random sample of 10 % of cases from the coordinating center was compared with original source documents Our findings suggest that the methodological approach applied to the CIED Registry resulted in high data completeness, accuracy, temporal plausibility, and excellent agreement levels with the source documents.

15.
Stud Health Technol Inform ; 307: 51-59, 2023 Sep 12.
Artigo em Inglês | MEDLINE | ID: mdl-37697837

RESUMO

INTRODUCTION: The collection of examination data for large clinical studies is often done with proprietary systems, which are accompanied by several disadvantages such as high cost and low flexibility. With the use of open-source tools, these disadvantages can be overcome and thereby improve data collection as well as data quality. Here we exemplary use the data collection process of the Hamburg City Health Study (HCHS), carried out at the University Medical Center Hamburg-Eppendorf (UKE). We evaluated how the recording of the examination data can be converted from an established, proprietary electronic healthcare record (EHR) system to the free-to-use Research Electronic Data Capture (REDCap) software. METHODS: For this purpose, a technical conversion of the EHR system is described first. Metafiles derived from the EHR system were used for REDCap electronic case report form (eCRF) building. The REDCap system was tested by HCHS study assistants via completion of self-developed tasks mimicking their everyday study life. Usability was quantitatively evaluated via the IBM Computer System Usability Questionnaire (CSUQ) and qualitatively assessed with a semi-structured interview. RESULTS: With the IBM CSUQ, the study assistants rated the usage of the basic REDCap system for HCHS examination data collection with an overall score of 4.39, which represents a medium acceptance. The interview feedback was used to formulate user stories to subsequently increase the administrative sovereignty and to conceptualize a REDCap HCHS information technology (IT) infrastructure. CONCLUSION: Our work aims to serve as a template for evaluating the feasibility of a conversion from a proprietary to a free-to-use data collection tool for large clinical studies such as the HCHS. REDCap has great potential, but extensions and an integration to the current IT infrastructure are required.


Assuntos
Centros Médicos Acadêmicos , Confiabilidade dos Dados , Humanos , Coleta de Dados , Sistemas Computacionais , Eletrônica
16.
JAMIA Open ; 6(3): ooad074, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37649989

RESUMO

Objective: Patient-reported outcome measures (PROMs) are critical to drive patient-centered care and to understanding patients' perspectives on their health status, quality of life, and the overall effectiveness of the care they receive. PROMs are increasingly being used in clinical and research settings, but the mechanisms to aggregate data from different systems can be cumbersome. Materials and methods: As part of an FDA Real-World Evidence demonstration project, we enriched routine care clinical data from our Cerner electronic health record (EHR) with PROMs collected using REDCap. We used SSIS, sFTP, and the REDCap Application Programming Interface to aggregate both data sources into the Cerner HealtheIntent Population Health Platform. Results: We successfully built dashboards, reports, and datasets containing both REDCap and EHR data collected prospectively. Discussion: This technically straightforward approach using commonly available clinical and research tools can be readily adopted and adapted by others to better integrate PROMs with clinical data sources.

17.
J Clin Transl Sci ; 7(1): e153, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37528946

RESUMO

Introduction: Designing and conducting clinical trials is challenging for some institutions and researchers due to associated time and personnel requirements. We conducted recruitment, screening, informed consent, study product distribution, and data collection remotely. Our objective is to describe how to conduct a randomized clinical trial using remote and automated methods. Methods: A randomized clinical trial in healthcare workers is used as a model. A random group of workers were invited to participate in the study through email. Following an automated process, interested individuals scheduled consent/screening interviews. Enrollees received study product by mail and surveys via email. Adherence to study product and safety were monitored with survey data review and via real-time safety alerts to study staff. Results: A staff of 10 remotely screened 406 subjects and enrolled 299 over a 3-month period. Adherence to study product was 87%, and survey data completeness was 98.5% over 9 months. Participants and study staff scored the System Usability Scale 93.8% and 90%, respectively. The automated and remote methods allowed the study maintenance period to be managed by a small study team of two members, while safety monitoring was conducted by three to four team members. Conception of the trial to study completion was 21 months. Conclusions: The remote and automated methods produced efficient subject recruitment with excellent study product adherence and data completeness. These methods can improve efficiency without sacrificing safety or quality. We share our XML file for researchers to use as a template for learning purposes or designing their own clinical trials.

18.
J Am Med Inform Assoc ; 30(10): 1634-1644, 2023 09 25.
Artigo em Inglês | MEDLINE | ID: mdl-37487555

RESUMO

OBJECTIVE: Rare disease research requires data sharing networks to power translational studies. We describe novel use of Research Electronic Data Capture (REDCap), a web application for managing clinical data, by the National Mesothelioma Virtual Bank, a federated biospecimen, and data sharing network. MATERIALS AND METHODS: National Mesothelioma Virtual Bank (NMVB) uses REDCap to integrate honest broker activities, enabling biospecimen and associated clinical data provisioning to investigators. A Web Portal Query tool was developed to source and visualize REDCap data in interactive, faceted search, enabling cohort discovery by public users. An AWS Lambda function behind an API calculates the counts visually presented, while protecting record level data. The user-friendly interface, quick responsiveness, automatic generation from REDCap, and flexibility to new data, was engineered to sustain the NMVB research community. RESULTS: NMVB implementations enabled a network of 8 research institutions with over 2000 mesothelioma cases, including clinical annotations and biospecimens, and public users' cohort discovery and summary statistics. NMVB usage and impact is demonstrated by high website visits (>150 unique queries per month), resource use requests (>50 letter of interests), and citations (>900) to papers published using NMVB resources. DISCUSSION: NMVB's REDCap implementation and query tool is a framework for implementing federated and integrated rare disease biobanks and registries. Advantages of this framework include being low-cost, modular, scalable, and efficient. Future advances to NVMB's implementations will include incorporation of -omics data and development of downstream analysis tools to advance mesothelioma and rare disease research. CONCLUSION: NVMB presents a framework for integrating biobanks and patient registries to enable translational research for rare diseases.


Assuntos
Mesotelioma , Doenças Raras , Humanos , Software , Pesquisa Translacional Biomédica , Bancos de Espécimes Biológicos
19.
BMC Med Res Methodol ; 23(1): 162, 2023 07 06.
Artigo em Inglês | MEDLINE | ID: mdl-37415099

RESUMO

BACKGROUND: Adaptive interventions are often used in individualized health care to meet the unique needs of clients. Recently, more researchers have adopted the Sequential Multiple Assignment Randomized Trial (SMART), a type of research design, to build optimal adaptive interventions. SMART requires research participants to be randomized multiple times over time, depending upon their response to earlier interventions. Despite the increasing popularity of SMART designs, conducting a successful SMART study poses unique technological and logistical challenges (e.g., effectively concealing and masking allocation sequence to investigators, involved health care providers, and subjects) in addition to other challenges common to all study designs (e.g., study invitations, eligibility screening, consenting procedures, and data confidentiality protocols). Research Electronic Data Capture (REDCap) is a secure, browser-based web application widely used by researchers for data collection. REDCap offers unique features that support researchers' ability to conduct rigorous SMARTs. This manuscript provides an effective strategy for performing automatic double randomization for SMARTs using REDCap. METHODS: Between January and March 2022, we conducted a SMART using a sample of adult (age 18 and older) New Jersey residents to optimize an adaptive intervention to increase COVID-19 testing uptake. In the current report, we discuss how we used REDCap for our SMART, which required double randomization. Further, we share our REDCap project XML file for future investigators to use when designing and conducting SMARTs. RESULTS: We report on the randomization feature that REDCap offers and describe how the study team automated an additional randomization that was required for our SMART. An application programming interface was used to automate the double randomizations in conjunction with the randomization feature provided by REDCap. CONCLUSIONS: REDCap offers powerful tools to facilitate the implementation of longitudinal data collection and SMARTs. Investigators can make use of this electronic data capturing system to reduce errors and bias in the implementation of their SMARTs by automating double randomization. TRIAL REGISTRATION: The SMART study was prospectively registered at Clinicaltrials.gov; registration number: NCT04757298, date of registration: 17/02/2021.


Assuntos
COVID-19 , Adulto , Humanos , Adolescente , Teste para COVID-19 , Distribuição Aleatória , Eletrônica
20.
South Afr J HIV Med ; 24(1): 1482, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37293602

RESUMO

Background: Index contact testing is an HIV case-finding approach that elicits sexual or needle-sharing partners, as well as biological children, of people living with HIV (PLHIV) and offers them HIV testing services. Objectives: We aim to describe the results of an innovative project in Sedibeng District that expanded index testing by retesting previously negative contacts and incorporating status-neutral testing. Method: We used registers to identify people who previously tested HIV-negative through index testing from March 2019 to September 2021. The individuals were telephonically traced and offered HIV retesting. Data were collected on a weekly basis using REDCap®. We monitored the number of individuals called, those who came back for retest, and their HIV results. Results: Fifteen counsellors contacted 968 people over 12 months. Forty-eight percent (462 out of 968) of those called returned for testing. Of those, 121 (26%) tested positive. Overall, 66 out of 276 (24%) men with HIV and 55 out of 186 (30%) women with HIV were identified and linked to antiretroviral treatment (ART). Fifty-seven percent (194 out of 341) of clients who tested HIV-negative were offered, and 124 out of 194 (64%) initiated, pre-exposure prophylaxis (PrEP). All individuals who retested HIV-positive had a new diagnosis; none reported having had another positive test result between the original negative and the positive retest. Conclusion: Revisiting index clients with a previous negative HIV test result is worthwhile, creating an opportunity to identify undiagnosed PLHIV and high-risk people for PrEP. The high positivity rate highlights the importance of providing a sero-neutral approach to HIV testing, including integrating prevention messaging and linkage to PrEP services.

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