Dataset Information

Management strategies for implementing a multicenter cross-sectional study: lessons from the ADHERE Brazil study.

ABSTRACT:

Background

Epidemiological studies involving large samples usually face financial and operational challenges.

Objectives

To describe the planning and execution of ADHERE Brazil, an epidemiological study on 1,105 kidney transplant patients, and report on how the study was structured, difficulties faced and solutions found.

Design and setting

Cross-sectional multicenter study in 20 Brazilian kidney transplantation centers.

Methods

Actions developed in each phase of implementation were described, with emphasis on innovations used within the logistics of this study, aimed at estimating the prevalence of nonadherence to treatment.

Results

Coordination of activities was divided into four areas: general, regulatory, data collection and statistics. Weekly meetings were held for action planning. The general coordination team was in charge of project elaboration, choice of participating centers, definition of publication policy and monitoring other coordination teams. The regulatory team provided support to centers for submitting the project to ethics committees. The data collection team prepared a manual on the electronic collection system, scheduled web meetings and was available to respond to queries. It also monitored the data quality and reported any inadequacies found. Communication with the centers was through monthly reports via e-mail and distribution of exclusive material. The statistical team acted in all phases of the study, especially in creating the data analysis plan and data bank, generation of randomization lists and data extraction.

Conclusions

Through these logistics, we collected high-quality data and built a local research infrastructure for further studies. We present supporting alternatives for conducting similar studies.

Clinical trial annotation

http://clinicaltrials.gov/ on October 10, 2013; NCT02066935.

SUBMITTER: Marsicano-Souza EO

PROVIDER: S-EPMC9671250 | biostudies-literature | 2022 May-Jun

REPOSITORIES: biostudies-literature

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Publications

Management strategies for implementing a multicenter cross-sectional study: lessons from the ADHERE Brazil study.

Marsicano-Souza Elisa Oliveira EO Colugnati Fernando Antônio Basile FAB de Castro Barbara Bruna Abreu BBA Van Keullen Maria do Socorro MDS De Geest Sabina S Sanders-Pinheiro Helady H

Sao Paulo medical journal = Revista paulista de medicina 20220501 3

<h4>Background</h4>Epidemiological studies involving large samples usually face financial and operational challenges.<h4>Objectives</h4>To describe the planning and execution of ADHERE Brazil, an epidemiological study on 1,105 kidney transplant patients, and report on how the study was structured, difficulties faced and solutions found.<h4>Design and setting</h4>Cross-sectional multicenter study in 20 Brazilian kidney transplantation centers.<h4>Methods</h4>Actions developed in each phase of imp ...[more]

PMID: 35507993

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Project description:BackgroundNon-adherence to immunosuppressive therapy is a prevalent risk factor for poor clinical and after kidney transplantation (KT), and has contributed to the lack of improvement in long-term graft survival over the past decade. Understanding the multilevel correlates and risk factors of non-adherence is crucial to determine the optimal level for planning interventions, namely at the patient, health care provider, KT centre, and health care system level. Brazil, having the largest public transplantation program in the world and with regional differences regarding access to health services and service implementation, is in a unique position to study this multilevel approach. Therefore, the Adhere Brazil Study (ADHERE BRAZIL) was designed to assess the prevalence and variability of non-adherence to immunosuppressants and to health behaviours among adult KT recipients in Brazil, and to assess the multilevel correlates of non-adherence to immunosuppressive medication. We describe the rationale, design, and methodology of the ADHERE BRAZIL study.Methods/designThis is an observational, cross-sectional, multicentre study that includes 20 Brazilian KT centres. A stratified sampling approach is used, based on strata, with the following characteristics considered: geographical region and transplant activity (number of KTs per year). A random sample of patients (proportional to the size of the centre within each stratum) is selected from each centre. The prevalence of different health behaviours is assessed through self-report. The assessment of multilevel correlates of non-adherence is guided by the ecological model that considers factors at the level of the patient, health-care professional, and transplant centre, using established instruments or instruments developed for this study. Data will be collected over an 18-month period, with information obtained during the regular follow-up visits to the transplant outpatient clinic and directly entered into the Research Electronic Data Capture (RedCap) system. Data entry is performed by a trained professional who is part of the transplant team. The data collection began in December 2015.DiscussionThis multicentre study is the first to evaluate multilevel correlates of non-adherence in KT patients and will provide a reliable estimate of non-adherence in Brazilian KT patients.Trial registrationClinicalTrials.gov on 10/10/2013, NCT02066935 .

Project description:Abstract Introduction COVID-19 has been declared a pandemic by the World Health Organization (WHO). Many of the COVID-19 patients develop acute respiratory distress syndrome (ARDS) and require ventilatory support based on their severity for which conventional strategies are being used along with few newer strategies. We conducted this multicenter survey to know the physician's current ventilation strategies adopted for the care of COVID-19 patients. Materials and methods The survey was conducted after taking the ethical committee clearance. The web-based multicenter, cross-sectional questionnaire study was sent to physicians, who were involved in the management of COVID-19 patients. The questionnaire was segregated into three parts: part one consisted of general information and consent form, part two was concerned regarding demographic characteristics, and part three was concerned about their practices and strategies for ventilation of COVID-19 patients. Results A total of 223 responders replied for the questionnaire; 190 participated in the study saying that they are involved in the management of COVID-19 patients. The answers to the questionnaires were expressed as a percentage of total responses. 86% of the respondents said they have a designated intensive care unit (ICU) and 89% of the responders said they have an intubation/extubation protocol for suspect/confirmed COVID-19 patients. The responses of junior residents (JRs), senior residents (SRs), assistant professors/junior consultants, and professors/consultants were analyzed separately, and a few significant differences were observed. 39% of JRs were aware of prone ventilation as the most effective rescue ventilation strategy compared to 69% of consultants/professors. Extracorporeal membranous oxygenation (ECMO) strategy was also more significant in consultants/professors (40%) vs JRs (12%). The responders were also diverged based on medical college and corporate hospitals, and their responses were noted. Most commonly, responders in the corporate hospitals had a facility to ventilate COVID-19 patients in a negative pressure isolation facility compared to a nonnegative pressure room isolation facility in medical colleges. Conclusion Most of the responders were practicing ventilation strategies in a standard manner. JRs need to undergo further training in a few aspects of the ventilatory management, and also, they need to update themselves with newer treatment modalities as they keep evolving. Medical colleges are providing at par facility compared to corporate hospitals except for few advance care facilities. Clinical significance This study highlights the current practice of ventilatory management of COVID-19 patients, which is satisfactory. The survey can be used to develop study tools, to educate resident doctors, to further improve quality of care of critical COVID-19 patients. How to cite this article Maddani SS, Deepa HC, Rao S, Chaudhuri S. A Multicenter Cross-sectional Questionnaire-based Study to know the Practices and Strategies of Ventilatory Management of COVID-19 Patients among the Treating Physicians. Indian J Crit Care Med 2020;24(8):643–648.

Project description:BackgroundThe use of web-based methods to collect population-based health behavior data has burgeoned over the past two decades. Researchers have used web-based platforms and research panels to study a myriad of topics. Data cleaning prior to statistical analysis of web-based survey data is an important step for data integrity. However, the data cleaning processes used by research teams are often not reported.ObjectiveThe objectives of this manuscript are to describe the use of a systematic approach to clean the data collected via a web-based platform from panelists and to share lessons learned with other research teams to promote high-quality data cleaning process improvements.MethodsData for this web-based survey study were collected from a research panel that is available for scientific and marketing research. Participants (N=4000) were panelists recruited either directly or through verified partners of the research panel, were aged 18 to 45 years, were living in the United States, had proficiency in the English language, and had access to the internet. Eligible participants completed a health behavior survey via Qualtrics. Informed by recommendations from the literature, our interdisciplinary research team developed and implemented a systematic and sequential plan to inform data cleaning processes. This included the following: (1) reviewing survey completion speed, (2) identifying consecutive responses, (3) identifying cases with contradictory responses, and (4) assessing the quality of open-ended responses. Implementation of these strategies is described in detail, and the Checklist for E-Survey Data Integrity is offered as a tool for other investigators.ResultsData cleaning procedures resulted in the removal of 1278 out of 4000 (31.95%) response records, which failed one or more data quality checks. First, approximately one-sixth of records (n=648, 16.20%) were removed because respondents completed the survey unrealistically quickly (ie, <10 minutes). Next, 7.30% (n=292) of records were removed because they contained evidence of consecutive responses. A total of 4.68% (n=187) of records were subsequently removed due to instances of conflicting responses. Finally, a total of 3.78% (n=151) of records were removed due to poor-quality open-ended responses. Thus, after these data cleaning steps, the final sample contained 2722 responses, representing 68.05% of the original sample.ConclusionsExamining data integrity and promoting transparency of data cleaning reporting is imperative for web-based survey research. Ensuring a high quality of data both prior to and following data collection is important. Our systematic approach helped eliminate records flagged as being of questionable quality. Data cleaning and management procedures should be reported more frequently, and systematic approaches should be adopted as standards of good practice in this type of research.

Project description:ObjectivesTo determine the frequency of risk factors for hypertension among Chinese cardiologists using a nation-wide survey.DesignMulticenter, cross-sectional observational study.Setting2441 hospitals across China were surveyed between September 2016 and August 2017.ParticipantsAll in-service cardiologists were surveyed (n=28 924).InterventionsWeChat-based electronic data capture system, a social application in China (Tencent, Nanshan, China), was used for data acquisition. Physician subscribed to the WeChat official account of the China Cardiologist Heart Study, and filled out an online questionnaire that included age, gender, level of in-service hospital, professional title, academic degree, area of expertise and cardiovascular risk factors. All information was required.Primary and secondary outcome measuresThe primary outcome was the presence of cardiovascular risk factors. The secondary outcome was the impact of the risk factors on the occurrence of hypertension.ResultsAmong 28 924 Chinese cardiologists who completed the questionnaire, 57.6% had blood pressure of 130-139/80-89 mm Hg (5.3% were taking antihypertensive drugs) and 22.0% had blood pressure >140/>90 mm Hg (36.5% were taking antihypertensive drugs). The multivariable analysis showed that age, gender, academic degree, hospital level, body mass index (BMI), smoking and comorbidities were independently associated with hypertension among cardiologists (all p<0.05). Age, female gender, BMI, smoking, family history of cardiovascular diseases (CVDs) and comorbidities were independently associated with taking antihypertensive drugs among hypertensive cardiologists (all p<0.05). Age, hospital level, professional title, BMI, family history of CVDs and comorbidities were independently associated with reaching target blood pressure among hypertensive cardiologists taking antihypertensive drugs.ConclusionChinese cardiologists do not recognise and pay attention to their own blood pressure. Their rate of antihypertensive treatment was low. The identified risk factors could be used to identify cardiologists at higher risk for hypertension and for implementing preventive interventions.

Dataset Information

Management strategies for implementing a multicenter cross-sectional study: lessons from the ADHERE Brazil study.

Background

Objectives

Design and setting

Methods

Results

Conclusions

Clinical trial annotation

Publications

Management strategies for implementing a multicenter cross-sectional study: lessons from the ADHERE Brazil study.

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