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3.
Am J Public Health ; 111(S2): S101-S106, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-34314208

RESUMO

Objectives. To examine age and temporal trends in the proportion of COVID-19 deaths occurring out of hospital or in the emergency department and the proportion of all noninjury deaths assigned ill-defined causes in 2020. Methods. We analyzed newly released (March 2021) provisional COVID-19 death tabulations for the entire United States. Results. Children (younger than 18 years) were most likely (30.5%) and elders aged 64 to 74 years were least likely (10.4%) to die out of hospital or in the emergency department. In parallel, among all noninjury deaths, younger people had the highest proportions coded to symptoms, signs, and ill-defined conditions, and percentage symptoms, signs, and ill-defined conditions increased from 2019 to 2020 in all age-race/ethnicity groups. The majority of young COVID-19 decedents were racial/ethnic minorities. Conclusions. The high proportions of all noninjury deaths among children, adolescents, and young adults that were coded to ill-defined causes in 2020 suggest that some COVID-19 deaths were missed because of systemic failures in timely access to medical care for vulnerable young people. Public Health Implications. Increasing both availability of and access to the best hospital care for young people severely ill with COVID-19 will save lives and improve case fatality rates.


Assuntos
COVID-19/mortalidade , Codificação Clínica/normas , Controle de Formulários e Registros/normas , Garantia da Qualidade dos Cuidados de Saúde/normas , Adolescente , Idoso , COVID-19/epidemiologia , Causas de Morte , Criança , Pré-Escolar , Humanos , Masculino , Pessoa de Meia-Idade , Grupos Minoritários/estatística & dados numéricos , Controle de Qualidade , Distribuição por Sexo , Estados Unidos , Adulto Jovem
4.
J Forensic Leg Med ; 82: 102220, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34325081

RESUMO

The prevalence of death certificate (DC) completion errors is a universal issue. This research aimed to estimate the global prevalence of DC errors by performing a systematic review and meta-analysis. Databases including Web of Science, PubMed, Science Direct, Scopus, and Google search engine were searched by September 4, 2020. Thirty-five articles were included in the final analysis. The exact Clopper-Pearson confidence intervals, heterogeneity assessment, random effects models with Mantel-Haenszel methods were employed using STATA version 14.2 software. Absence of time interval (80.9%), absence/inappropriateness of comorbidities (45.1%), incorrect underlying cause-of-death (COD) statement (38.9%), improper sequence (36.2%), mechanism of death with underlying COD (UCOD) (33.6%), abbreviations (33.0%), mechanism only (23.9%), competing causes (21.5%), two or more condition per line (19.3%), incorrect COD (18.0%), nonspecific or ill-defined condition (16.4%), blanks/repetitive phrases (12.5%), and illegible handwriting (11.6%) were the most prevalent errors, respectively. Lack of or poor training/educating of certifiers, lack of physician understandings about the importance of DC and absence of quality assurance mechanisms were identified as the most significant causes of DC errors. Furthermore, providing ongoing, targeted and interactive training/education, and establishment of quality control and tracking mechanisms for completion of deficient DCs were suggested as the important improving solutions.


Assuntos
Causas de Morte , Atestado de Óbito , Confiabilidade dos Dados , Controle de Formulários e Registros/normas , Humanos
6.
Radiology ; 300(1): 187-189, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-33944630

RESUMO

Patients have a right to their medical records, and it has become commonplace for institutions to set up online portals through which patients can access their electronic health information, including radiology reports. However, institutional approaches vary on how and when such access is provided. Many institutions have advocated built-in "embargo" periods, during which radiology reports are not immediately released to patients, to give ordering clinicians the opportunity to first receive, review, and discuss the radiology report with their patients. To understand current practices, a telephone survey was conducted of 83 hospitals identified in the 2019-2020 U.S. News & World Report Best Hospitals Rankings. Of 70 respondents, 91% (64 of 70) offered online portal access. Forty-two percent of those with online access (27 of 64 respondents) reported a delay of 4 days or longer, and 52% (33 of 64 respondents) indicated that they first send reports for review by the referring clinician before releasing to the patient. This demonstrates a lack of standardized practice in prompt patient access to health records, which may soon be mandated under the final rule of the 21st Century Cures Act. This article discusses considerations and potential benefits of early access for patients, radiologists, and primary care physicians in communicating health information and providing patient-centered care. © RSNA, 2021.


Assuntos
Acesso à Informação , Registros Eletrônicos de Saúde/normas , Portais do Paciente/normas , Sistemas de Informação em Radiologia/normas , Controle de Formulários e Registros/normas , Registros de Saúde Pessoal , Humanos , Inquéritos e Questionários , Fatores de Tempo , Estados Unidos
7.
J Burn Care Res ; 42(3): 526-532, 2021 05 07.
Artigo em Inglês | MEDLINE | ID: mdl-33128370

RESUMO

Systematic data collection in high-income countries has demonstrated a decreasing burn morbidity and mortality, whereas lack of data from low- and middle-income countries hinders a global overview of burn epidemiology. In low- and middle-income countries, dedicated burn registries are few. Instead, burn data are often recorded in logbooks or as one variable in trauma registries, where incomplete or inconsistently recorded information is a known challenge. The University Teaching Hospital of Kigali hosts the only dedicated burn unit in Rwanda and has collected data on patients admitted for acute burn care in logbooks since 2005. This study aimed to assess the data registered between January 2005 and December 2019, to evaluate the extent of missing data, and to identify possible factors associated with "missingness." All data were analyzed using descriptive statistics, Fisher's exact test, and Wilcoxon Rank Sum test. In this study, 1093 acute burn patients were included and 64.2% of them had incomplete data. Data completeness improved significantly over time. The most commonly missing variables were whether the patient was referred from another facility and information regarding whether any surgical intervention was performed. Missing data on burn mechanism, burn degree, and surgical treatment were associated with in-hospital mortality. In conclusion, missing data is frequent for acute burn patients in Rwanda, although improvements have been seen over time. As Rwanda and other low- and middle-income countries strive to improve burn care, ensuring data completeness will be essential for the ability to accurately assess the quality of care, and hence improve it.


Assuntos
Unidades de Queimados/normas , Queimaduras/terapia , Coleta de Dados/normas , Controle de Formulários e Registros/normas , Registros Médicos/normas , Qualidade da Assistência à Saúde , Queimaduras/mortalidade , Queimaduras/patologia , Países em Desenvolvimento , Mortalidade Hospitalar , Hospitais Universitários , Humanos , Ruanda
8.
Mod Pathol ; 33(12): 2382-2396, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-32415266

RESUMO

The terminology and diagnostic criteria presently used by pathologists to report invasive placentation is inconsistent and does not reflect current knowledge of the pathogenesis of the disease or the needs of the clinical care team. A consensus panel was convened to recommend terminology and reporting elements unified across the spectrum of PAS specimens (i.e., delivered placenta, total or partial hysterectomy with or without extrauterine tissues, curetting for retained products of conception). The proposed nomenclature under the umbrella diagnosis of placenta accreta spectrum (PAS) replaces the traditional categorical terminology (placenta accreta, increta, percreta) with a descriptive grading system that parallels the guidelines endorsed by the International Federation of Gynaecology and Obstetrics (FIGO). In addition, the nomenclature for hysterectomy specimens is separated from that for delivered placentas. The goal for each element in the system of nomenclature was to provide diagnostic criteria and guidelines for expected use in clinical practice.


Assuntos
Registros Médicos/normas , Patologia Clínica/normas , Placenta Acreta/patologia , Placenta/patologia , Placentação , Terminologia como Assunto , Biópsia , Consenso , Documentação/normas , Feminino , Controle de Formulários e Registros/normas , Humanos , Histerectomia , Placenta/cirurgia , Placenta Acreta/classificação , Placenta Acreta/cirurgia , Valor Preditivo dos Testes , Gravidez , Índice de Gravidade de Doença
9.
Rev. clín. esp. (Ed. impr.) ; 220(4): 215-227, mayo 2020. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-194885

RESUMO

INTRODUCCIÓN: El certificado médico de defunción es un documento con una doble función: registro oficial del fallecimiento de una persona y análisis estadístico de las causas de muerte de la población. La cumplimentación de este documento en la práctica clínica genera grandes conflictos. OBJETIVOS: Analizar la cumplimentación y detectar los principales errores que existen al rellenar estos documentos. Se procedió a la comparación de las variables más importantes entre los diferentes tipos de documentos analizados. MATERIAL Y MÉTODOS: Estudio transversal descriptivo. Se analizaron 513 certificados del municipio de Madrid. El análisis incluía documentos oficiales, nuevos y antiguos, y de los hospitales. RESULTADOS: Como principal hallazgo destacó que 316 documentos empleaban el término «parada cardiorrespiratoria» como causa inmediata de muerte. En otros 98 casos se emplearon otras causas inmediatas mal definidas. También se pudo concluir que los documentos de los hospitales no siempre tienen los apartados requeridos para que el certificado haga su función legal. En los certificados de la Organización Médica Colegial existe una peor cumplimentación en el documento actual porque el propio documento dificulta que se rellene adecuadamente y precisa una mejor formación del médico para rellenarlo. CONCLUSIONES: Se proponen posibles mejoras en el propio documento oficial para que se consideren las exigencias legales, se facilite su cumplimentación y cumpla su función. También se proponen recomendaciones para los hospitales que tengan su propio documento y sugerencias de mejora de la cumplimentación


BACKGROUND: The medical certificate of cause of death is a dual-purpose document: an official registration of an individual's death and a statistical analysis of the populational causes of death. However, the completion of this document in clinical practice creates significant conflicts. OBJECTIVES: To analyse the completion and detect the main errors that occur when filling in these documents. We then compared the most important variables between the various types of documents analysed. MATERIAL AND METHODS: We conducted a descriptive cross-sectional study that analysed 513 certificates in the municipality of Madrid, Spain. The analysis included official documents (new and old versions) and hospital documents. RESULTS: The study's main finding was that 316 documents employed the term "cardiopulmonary arrest" as the immediate cause of death. In 98 other cases, other poorly defined immediate causes were listed. We were able to conclude that the hospital documents do not always have the required sections for the certificate to be legally functional. In the Professional Medical Association certificates, there is poorer completion of the current document because the document itself hinders its appropriate completion and requires better physician training to complete. CONCLUSIONS: We propose possible improvements to the official document so that it meets the legal requirements, facilitates its completion and fulfils its function. We also offer recommendations for hospitals that have their own document and suggestions for improving its completion


Assuntos
Humanos , Causas de Morte , Atestado de Óbito , Estudos Transversais , Erros de Diagnóstico , Epidemiologia Descritiva , Médicos , Médicos Legistas , Controle de Formulários e Registros/normas , Espanha/epidemiologia
11.
Chest ; 158(2): 698-704, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32084393

RESUMO

In early 2018, the Centers for Medicare & Medicaid Services released the Medical Review of Evaluation and Management (E/M) Documentation, which allows supervising teaching physicians to rely on a medical student's documentation to support billing for E/M services. This change has potential to enhance education, clinical documentation quality, and the satisfaction of students, postgraduate trainees, and teaching physicians. However, its practical adoption presents many challenges that must be navigated successfully to realize these important goals in compliance with federal and local requirements, while avoiding unintended downstream problems. Implementation requires careful planning, policy creation, education, and monitoring, all with collaboration between institutional leaders, compliance and information technology professionals, educators, and learners. In this paper, we review the 2018 Centers for Medicare & Medicaid Services rule change, address common questions and potential impacts, outline practical workflows to meet the supervision requirement, and discuss steps for successful implementation.


Assuntos
Documentação/normas , Controle de Formulários e Registros/normas , Medicaid/economia , Medicare/economia , Estudantes de Medicina , Centers for Medicare and Medicaid Services, U.S. , Humanos , Medicaid/legislação & jurisprudência , Medicare/legislação & jurisprudência , Estados Unidos
12.
J Med Syst ; 44(3): 62, 2020 Feb 08.
Artigo em Inglês | MEDLINE | ID: mdl-32036459

RESUMO

Coded data are the basis of information systems in all countries that rely on Diagnosis Related Groups in order to reimburse/finance hospitals, including both administrative and clinical data. To identify the problems and barriers that affect the quality of the coded data is paramount to improve data quality as well as to enhance its usability and outcomes. This study aims to explore problems and possible solutions associated with the clinical coding process. Problems were identified according to the perspective of ten medical coders, as the result of four focus groups sessions. This convenience sample was sourced from four public hospitals in Portugal. Questions relating to problems with the coding process were developed from the literature and authors' expertise. Focus groups sessions were taped, transcribed and analyzed to elicit themes. Variability in the documents used for coding, illegibility of hand writing when coding on paper, increase of errors due to an extra actor in the coding process when transcribed from paper, difficulties in the diagnoses' coding, coding delay and unavailability of resources and tools designed to help coders, were some of the problems identified. Some problems were identified and solutions such as the standardization of the documents used for coding an episode, the adoption of the electronic coding, the development of tools to help coding and audits, and the recognition of the importance of coding by the management were described as relevant factors for the improvement of the quality of data.


Assuntos
Codificação Clínica/normas , Grupos Diagnósticos Relacionados/classificação , Controle de Formulários e Registros/normas , Registros Médicos/normas , Competência Profissional/normas , Grupos Focais , Humanos , Classificação Internacional de Doenças , Portugal
13.
AJR Am J Roentgenol ; 214(4): 835-842, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32023118

RESUMO

OBJECTIVE. The objective of this study was to assess impact of a report template quality improvement (QI) initiative on use of preferred phrases for communicating normal findings in structured abdominal CT and MRI reports. SUBJECTS AND METHODS. This prospective QI initiative, designed to decrease use of equivocal phrases and increase use of preferred and acceptable phrases (defined by multidisciplinary experts including patient advocates) in radiology reports, was performed in an academic medical center with over 800,000 annual radiologic examinations and was exempt from institutional review board approval. The intervention populated the preferred term "normal" (default) and acceptable specified pertinent negative phrases (pick-list option) when describing abdominal organ subheadings (liver, pancreas, spleen, adrenal glands, kidneys) within the "Findings" heading of abdominal CT and MRI report templates. We tabulated frequencies of the term "normal", specified pertinent negatives, and equivocal phrases in 21,629 reports before (June 1, 2017, to February 28, 2018) and 23,051 reports after (April 1, 2018, to December 31, 2018) the intervention using natural language processing and recorded trainee participation in report generation. We assessed intervention impact using statistical process control (SPC) charts and the Fisher exact test. RESULTS. Equivocal phrases were used less frequently in abdominal CT and MRI reports for both attending radiologists and trainees after the intervention (p < 0.05, SPC). Use of the term "normal" increased for reports generated by attending radiologists alone but decreased for reports created with trainee participation (p < 0.05, SPC). Frequency of pertinent negatives increased for reports with trainee participation (p < 0.05, SPC). CONCLUSION. A QI intervention decreased use of equivocal terms and increased use of preferred and acceptable phrases when communicating normal findings in abdominal CT and MRI reports.


Assuntos
Controle de Formulários e Registros/normas , Imageamento por Ressonância Magnética , Melhoria de Qualidade , Terminologia como Assunto , Tomografia Computadorizada por Raios X , Humanos , Estudos Prospectivos , Sistemas de Informação em Radiologia
14.
Australas Psychiatry ; 28(2): 171-174, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32019349

RESUMO

OBJECTIVE: To assess the impact of a 2015 reform to the Mental Health Act 2007 (NSW) (MHA) that was interpreted as requiring a reference to decision-making capacity (DMC) in reports to the NSW Mental Health Review Tribunal (MHRT). METHOD: A sample of reports to the MHRT were audited for references to the MHA's treatment criteria and DMC in periods before and after the reforms, and the frequency of references between the two periods was compared. RESULTS: The frequency of references to DMC did not change significantly after the reforms. (However, references to the 'least restriction' criterion increased markedly between the two periods). CONCLUSION: Despite legislative reforms and a supporting education campaign promoting the importance of consideration of DMC, references to DMC did not increase after the reforms.


Assuntos
Internação Compulsória de Doente Mental/normas , Controle de Formulários e Registros/normas , Reforma dos Serviços de Saúde , Auditoria Médica , Transtornos Mentais/terapia , Adulto , Tomada de Decisões , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Amostragem
15.
J Trauma Acute Care Surg ; 89(1): 199-207, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-31914009

RESUMO

BACKGROUND: Accurate and reliable data are pivotal to credible risk-adjusted modeling and hospital benchmarking. Evidence assessing the reliability and accuracy of data elements considered as variables in risk-adjustment modeling and measurement of outcomes is lacking. This deficiency holds the potential to compromise benchmarking integrity. We detail the findings of a longitudinal program to evaluate the impact of external data validation on data validity and reliability for variables utilized in benchmarking of trauma centers. METHODS: A collaborative quality initiative-based study was conducted of 29 trauma centers from March 2010 through December 2018. Case selection criteria were applied to identify high-yield cases that were likely to challenge data abstractors. There were 127,238 total variables validated (i.e., reabstracted, compared, and reported to trauma centers). Study endpoints included data accuracy (agreement between registry data and contemporaneous documentation) and reliability (consistency of accuracy within and between hospitals). Data accuracy was assessed by mean error rate and type (under capture, inaccurate capture, or over capture). Cohen's kappa estimates were calculated to evaluate reliability. RESULTS: There were 185,120 patients that met the collaborative inclusion criteria. There were 1,243 submissions reabstracted. The initial validation visit demonstrated the highest mean error rate at 6.2% ± 4.7%, and subsequent validation visits demonstrated a statistically significant decrease in error rate compared with the first visit (p < 0.05). The mean hospital error rate within the collaborative steadily improved over time (2010, 8.0%; 2018, 3.2%) compared with the first year (p < 0.05). Reliability of substantial or higher (kappa ≥0.61) was demonstrated in 90% of the 20 comorbid conditions considered in the benchmark risk-adjustment modeling, 39% of these variables exhibited a statistically significant (p < 0.05) interval decrease in error rate from the initial visit. CONCLUSION: Implementation of an external data validation program is correlated with increased data accuracy and reliability. Improved data reliability both within and between trauma centers improved risk-adjustment model validity and quality improvement program feedback.


Assuntos
Benchmarking , Controle de Formulários e Registros/normas , Melhoria de Qualidade , Centros de Traumatologia/normas , Humanos , Michigan , Sistema de Registros , Reprodutibilidade dos Testes , Estudos Retrospectivos , Estados Unidos
16.
Health Inf Manag ; 49(1): 5-18, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31159578

RESUMO

BACKGROUND: Information technology has the potential to streamline processes in healthcare for improved efficiency, quality and safety, while reducing costs. Computer-assisted clinical coding (CAC) has made it possible to automate the clinical coding process by assigning diagnoses and procedures from electronic sources of clinical documentation. Implementation of CAC requires both investigation of the clinical coding workflow and exploration of how the clinical coding professional's role might change and evolve as a result of this technology. OBJECTIVE: To examine the benefits and limitations of CAC technology; best practices for CAC adoption; the impact of CAC on traditional coding practices and roles in the inpatient setting. METHOD: This narrative review explores the current literature available on CAC. Literature indexed in ProQuest, Medline and other relevant sources between January 2006 and June 2017 was considered. RESULTS: A total of 38 journal articles, published dissertations and case studies revealed that CAC has demonstrated value in improving clinical coding accuracy and quality, which can be missed during the manual clinical coding process. CONCLUSION: Clinical coding professionals should view CAC as an opportunity not a threat. CAC will allow clinical coding professionals to further develop their clinical coding skills and knowledge for future career progression into new roles such as clinical coding editors and clinical coding analysts. Sound change management strategies are essential for successful restructuring of the clinical coding workflows during the implementation of CAC.


Assuntos
Automação , Codificação Clínica/normas , Confiabilidade dos Dados , Controle de Formulários e Registros/normas , Administradores de Registros Médicos/normas , Papel Profissional , Humanos , Classificação Internacional de Doenças , Registros Médicos/normas , Competência Profissional
18.
Health Inf Manag ; 49(1): 28-37, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30744403

RESUMO

BACKGROUND: Health records are the basis of clinical coding. In Portugal, relevant diagnoses and procedures are abstracted and categorised using an internationally accepted classification system and the resulting codes, together with the administrative data, are then grouped into diagnosis-related groups (DRGs). Hospital reimbursement is partially calculated from the DRGs. Moreover, the administrative database generated with these data is widely used in research and epidemiology, among other purposes. OBJECTIVE: To explore the perceptions of medical coders (medical doctors) regarding possible problems with health records that may affect the quality of coded data. METHOD: A qualitative design using four focus groups sessions with 10 medical coders was undertaken between October and November 2017. The convenience sample was obtained from four public hospitals in Portugal. Questions related to problems with the coding process were developed from the literature and authors' expertise. The focus groups sessions were taped, transcribed and analysed to elicit themes. RESULTS: There are several problems, identified by the focus groups, in health records that influence the coded data: the lack of or unclear documented information; the variability in diagnosis description; "copy & paste"; and the lack of solutions to solve these problems. CONCLUSION AND IMPLICATIONS: The use of standards in health records, audits and physician awareness could increase the quality of health records, contributing to improvements in the quality of coded data, and in the fulfilment of its purposes (e.g. more accurate payments and more reliable research).


Assuntos
Codificação Clínica/normas , Confiabilidade dos Dados , Controle de Formulários e Registros/normas , Administradores de Registros Médicos , Registros Médicos/normas , Grupos Diagnósticos Relacionados/classificação , Grupos Focais , Humanos , Classificação Internacional de Doenças , Portugal , Competência Profissional , Pesquisa Qualitativa
19.
Eur Arch Otorhinolaryngol ; 277(1): 269-276, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31612337

RESUMO

PURPOSE: Free text reports (FTR) of head and neck ultrasound studies are currently deployed in most departments. Because of a lack of composition and language, these reports vary greatly in terms of quality and reliability. This may impair the learning process during residency. The purpose of the study was to analyze the longitudinal effects of using structured reports (SR) of head and neck ultrasound studies during residency. METHODS: Attending residents (n = 24) of a tripartite course on head and neck ultrasound, accredited by the German Society for Ultrasound in Medicine (DEGUM), were randomly allocated to pictures of common diseases. Both SRs and FTRs were compiled. All reports were analyzed concerning completeness, acquired time and legibility. Overall user contentment was evaluated by a questionnaire. RESULTS: SRs achieved significantly higher ratings regarding completeness (95.6% vs. 26.4%, p < 0.001), description of pathologies (72.2% vs. 58.9%, p < 0.001) and legibility (100% vs. 52.4%, p < 0.001) with a very high inter-rater reliability (Fleiss' kappa 0.9). Reports were finalized significantly faster (99.1 s vs. 115.0 s, p < 0.001) and user contentment was significantly better when using SRs (8.3 vs. 6.3, p < 0.001). In particular, only SRs showed a longitudinally increasing time efficiency (- 20.1 s, p = 0.036) while maintaining consistent completeness ratings. CONCLUSIONS: The use of SRs of head and neck ultrasound studies results in an increased longitudinal time-efficiency while upholding the report quality at the same time. This may indicate an additive learning effect of structured reporting. Superior outcomes in terms of comprehensiveness, legibility and time-efficiency can be observed immediately after implementation.


Assuntos
Neoplasias de Cabeça e Pescoço/diagnóstico por imagem , Internato e Residência/normas , Registros Médicos/normas , Ultrassonografia/normas , Adulto , Documentação/normas , Feminino , Controle de Formulários e Registros/normas , Cabeça/diagnóstico por imagem , Humanos , Masculino , Pescoço/diagnóstico por imagem , Sistemas de Informação em Radiologia/normas , Reprodutibilidade dos Testes , Inquéritos e Questionários
20.
Br J Clin Pharmacol ; 85(12): 2784-2792, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31471967

RESUMO

AIMS: Monitoring risk-based approaches in clinical trials are encouraged by regulatory guidance. However, the impact of a targeted source data verification (SDV) on data-management (DM) workload and on final data quality needs to be addressed. METHODS: MONITORING was a prospective study aiming at comparing full SDV (100% of data verified for all patients) and targeted SDV (only key data verified for all patients) followed by the same DM program (detecting missing data and checking consistency) on final data quality, global workload and staffing costs. RESULTS: In all, 137 008 data including 18 124 key data were collected for 126 patients from 6 clinical trials. Compared to the final database obtained using the full SDV monitoring process, the final database obtained using the targeted SDV monitoring process had a residual error rate of 1.47% (95% confidence interval, 1.41-1.53%) on overall data and 0.78% (95% confidence interval, 0.65-0.91%) on key data. There were nearly 4 times more queries per study with targeted SDV than with full SDV (mean ± standard deviation: 132 ± 101 vs 34 ± 26; P = .03). For a handling time of 15 minutes per query, the global workload of the targeted SDV monitoring strategy remained below that of the full SDV monitoring strategy. From 25 minutes per query it was above, increasing progressively to represent a 50% increase for 45 minutes per query. CONCLUSION: Targeted SDV monitoring is accompanied by increased workload for DM, which allows to obtain a small proportion of remaining errors on key data (<1%), but may substantially increase trial costs.


Assuntos
Confiabilidade dos Dados , Coleta de Dados/normas , Gerenciamento de Dados/normas , Bases de Dados Factuais/normas , Registros Eletrônicos de Saúde/normas , Controle de Formulários e Registros/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Carga de Trabalho/normas , Análise Custo-Benefício , Controle de Formulários e Registros/economia , Controle de Formulários e Registros/normas , Humanos , Estudos Prospectivos
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