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Background The credibility of a study and its internal and external validity depend crucially on the quality of the data produced. An in-depth knowledge of quality control processes is essential as large and integrative epidemiological studies are increasingly prioritized. Objective This study aimed to describe the stages of quality control in the POP-Brazil study and to present an analysis of the quality indicators. Methods Quality assurance and control were initiated with the planning of this nationwide, multicentric study and continued through the development of the project. All quality control protocol strategies, such as training, protocol implementation, audits, and inspection, were discussed one by one. We highlight the importance of conducting a pilot study that provides the researcher the opportunity to refine or modify the research methodology and validating the results through double data entry, test-retest, and analysis of nonresponse rates. Results This cross-sectional, nationwide, multicentric study recruited 8628 sexually active young adults (16-25 years old) in 119 public health units between September 2016 and November 2017. The Human Research Ethics Committee of the Moinhos de Vento Hospital approved this project. Conclusions Quality control processes are a continuum, not restricted to a single event, and are fundamental to the success of data integrity and the minimization of bias in epidemiological studies. The quality control steps described can be used as a guide to implement evidence-based, valid, reliable, and useful procedures in most observational studies to ensure data integrity. International Registered Report Identifier (IRRID) RR1-10.2196/31365
Background The credibility of a study and its internal and external validity depend crucially on the quality of the data produced. An in-depth knowledge of quality control processes is essential as large and integrative epidemiological studies are increasingly prioritized. Objective This study aimed to describe the stages of quality control in the POP-Brazil study and to present an analysis of the quality indicators. Methods Quality assurance and control were initiated with the planning of this nationwide, multicentric study and continued through the development of the project. All quality control protocol strategies, such as training, protocol implementation, audits, and inspection, were discussed one by one. We highlight the importance of conducting a pilot study that provides the researcher the opportunity to refine or modify the research methodology and validating the results through double data entry, test-retest, and analysis of nonresponse rates. Results This cross-sectional, nationwide, multicentric study recruited 8628 sexually active young adults (16-25 years old) in 119 public health units between September 2016 and November 2017. The Human Research Ethics Committee of the Moinhos de Vento Hospital approved this project. Conclusions Quality control processes are a continuum, not restricted to a single event, and are fundamental to the success of data integrity and the minimization of bias in epidemiological studies. The quality control steps described can be used as a guide to implement evidence-based, valid, reliable, and useful procedures in most observational studies to ensure data integrity. International Registered Report Identifier (IRRID) RR1-10.2196/31365
BACKGROUND The credibility of a study and its internal and external validity depend crucially on the quality of the data produced. Quality control aims to monitor sampling errors and measurements during the execution of a study and is based mainly on two pillars: planning and standardization of procedures. OBJECTIVE The present article aimed to describe the stages of quality control in the POP-Brazil study and to present an analysis of the quality indicators. METHODS Quality assurance and control included several phases and processes that were initiated with the planning of the study and continued through the development of the project; thus, all centers were trained in loco. RESULTS The data were through a structured questionnaire and collection of biological samples, both performed by more than 250 trained and certified health professionals. Furthermore, to correct possible inadequacies, all 119 centers (public health units) received at least one monitoring visit, which evaluated the professionals' performance and the process of completing the online data platform. The data were monitored daily and were audited through the double entry of data, performed by the central team. The reliability of data was analyzed through the test-retest method, comparing data from the online platform and a second application of the interview, and conducted through telephone, also by the central team. The agreement between the test and retest was considered good (kappa between 0.59 and 0.74). Large multicenter clinical trials are the basis of medical evidence-based and health-based prevention, so their design, logistics, and quality processes should always be carefully considered. CONCLUSIONS This article presents the processes and quality indicators in the POP-Brazil study that allow other studies to generate reliable data.
A assistência Farmacêutica abrange um conjunto de ações voltadas à promoção, proteção e recuperação da saúde em conformidade com os preceitos que asseguram seu uso, tanto no âmbito individual como no coletivo, entendendo-se como insumo básico o medicamento. Nesse contexto, a atuação da assistência farmacêutica traduz-se nas atitudes, habilidades, conhecimento e competência técnica do profissional farmacêutico, com base em metodologias científicas, voltada para a melhoria da qualidade de vida da sociedade. Sendo assim, a fim de dar norte a pesquisa, este artigo adotou como questão norteadora: como os profissionais farmacêuticos podem promover a saúde através de assistência e atenção básica farmacêutica e evitar desfechos de erros de administração de medicamentos? Para tanto, estabeleceu-se como objetivo apontar o propósito da assistência farmacêutica e o papel do profissional farmacêutico na prática clínica desta assistência para a melhoria da qualidade de vida do paciente. Diante disso, a metodologia utilizada para a construção deste artigo baseou-se na pesquisa bibliográfica, tendo como desfecho o reconhecimento da importância do papel do farmacêutico para o cuidado com o paciente na prática clínica, uma vez que visa a integração do conhecimento da farmacoterapia para se otimizar problemas relacionados aos medicamentos.
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