[Guidelines for quality control and management of death cases in medical institutions (2023)].

The report of death cases is an important source of information for cause analysis and monitoring of trends, which can reflect the death situation and characteristics of a population in a relatively accurate manner. It helps understand the health status of the population and the level of healthcare. The special deployment of case review for in-hospital deaths is not only the high priority for health authorities in terms of quality and safety of medical care but also a practical implementation of the concept that values people and life. Currently, there is a lack of scientific and standardized evaluation for the review of death cases in various specialties, excluding maternal and neonatal cases. To standardize the quality control and management of death cases in medical institutions, the Guidelines for quality control and management of death cases in medical institutions (2023) has been developed by the Hunan Province Resuscitation Quality Control Center. The members of the working group of this guideline visited medical institutions, conducted research, reviewed relevant guidelines from domestic and international sources, and integrated clinical experience to form a preliminary consensus. This consensus was submitted to the expert group for multiple discussions, underwent several revisions, and finally, it was sent to the experts in the form of a questionnaire for feedback. The guidelines clarify the scope, data collection, and quality control requirements for death case quality control, providing a reference for the quality control and management of death cases in medical institutions.

Relatório lançado pela OMS detalha o impacto devastador da hipertensão e as formas de combatê-la

A Organização Mundial da Saúde (OMS) publicou seu primeiro relatório sobre os efeitos globais devastadores da pressão alta, incluindo recomendações sobre como cobater esse assassino silencioso.

The Volume and Cost of Quality Metric Reporting.

Importance: US hospitals report data on many health care quality metrics to government and independent health care rating organizations, but the annual cost to acute care hospitals of measuring and reporting quality metric data, independent of resources spent on quality interventions, is not well known. Objective: To evaluate externally reported inpatient quality metrics for adult patients and estimate the cost of data collection and reporting, independent of quality-improvement efforts. Design, Setting, and Participants: Retrospective time-driven activity-based costing study at the Johns Hopkins Hospital (Baltimore, Maryland) with hospital personnel involved in quality metric reporting processes interviewed between January 1, 2019, and June 30, 2019, about quality reporting activities in the 2018 calendar year. Main Outcomes and Measures: Outcomes included the number of metrics, annual person-hours per metric type, and annual personnel cost per metric type. Results: A total of 162 unique metrics were identified, of which 96 (59.3%) were claims-based, 107 (66.0%) were outcome metrics, and 101 (62.3%) were related to patient safety. Preparing and reporting data for these metrics required an estimated 108 478 person-hours, with an estimated personnel cost of $5 038 218.28 (2022 USD) plus an additional $602 730.66 in vendor fees. Claims-based (96 metrics; $37 553.58 per metric per year) and chart-abstracted (26 metrics; $33 871.30 per metric per year) metrics used the most resources per metric, while electronic metrics consumed far less (4 metrics; $1901.58 per metric per year). Conclusions and Relevance: Significant resources are expended exclusively for quality reporting, and some methods of quality assessment are far more expensive than others. Claims-based metrics were unexpectedly found to be the most resource intensive of all metric types. Policy makers should consider reducing the number of metrics and shifting to electronic metrics, when possible, to optimize resources spent in the overall pursuit of higher quality.

Reporting system on mortality statistics in Lao People's Democratic Republic.

The system to collect information on mortality statistics in Lao PDR is not well established, accurate and timely death information is therefore not available. This article reports the system and process to make the mortality statistical data of Lao PDR. The country has a paper-based resident registration system, using a death notification document, a death certificate, and a family census book. The death notification document is important as it provides the cause of death, which is issued from a health facility and the village office. In the event of a death occurring at home, the family representative needs to report to the village office verbally to obtain a death notification document. On the other hand, if the death occurred in a medical facility, a death notification document from a health facility is provided. The family representative should bring the death notification document to the district Home Affairs office to register the death and obtain a death certificate. After that, the family representative needs to bring the death certificate to the district Public Security office for an amendment in the family census book. ICD-10 is under development regarding death notification from health facilities under the Ministry of Health. However, it is unclear how death notification from village offices can adopt ICD-10 as the majority of deaths occur outside health facilities. A comprehensive and integrated mortality reporting system is necessary in order to create a holistic health policy and welfare for the country.

O Câncer de Próstata Metastático Resistente à Castração no Brasil: um Estudo do Mundo Real Usando o Banco de Dados do INCA / Metastatic Castration-Resistant Prostate Cancer in Brazil: a Real-World Investigation Using INCA Database / El Cáncer de Próstata Metastático Resistente a Castración en el Brasil: Investigación en el Mundo Real Usando la Base de Datos del INCA

Introduction: Prostate cancer is the second most common cancer in men worldwide. In Brazil, regional disparities in incidences of intermediate and high-risk in late-diagnosed PC cases are expected. Objective: To investigate the clinical and demographic profiles of patients treated with metastatic castration-resistant prostate cancer (mCRPC) in Brazil, using real-world data from public databases. Method: Prostate cancer data from the Brazilian cancer registries were filtered from Brazilian public databases from 2008 to 2018. The number of health institutions and registries at a cancer public database were used to separate the Brazilian Federative Units into two comparison groups. mCRPC patients were estimated by using a combination of filters of staging and treatment (Tx, Nx and M1 + chemotherapy). The patients' median age and the number and type of treatments were evaluated. Results: A total of 325,987 patients with prostate cancer and 5,367 patients with mCRPC were identified. The median age of the mCRPC patients was 63 years. The percentage of patients who underwent one, two or three treatments was 21.0%, 43.2% and 28.1%, respectively. In addition, management differences were noticed depending on the group analyzed. Conclusion: The results revealed regional discrepancies in the distribution of registered mCRPC patients in the Brazilian territory and in their treatment. This information can be used to strengthen the recently updated treatment and improve the palliative care offered. This work presents suggestions to improve specific prostate cancer databases

Introdução: O câncer de próstata é o segundo tipo mais comum em homens ao redor do mundo. No Brasil, diferenças regionais de incidência em casos de risco intermediário e alto tardiamente diagnosticados são esperadas. Objetivo: Investigar os perfis clínico e demográfico de pacientes com câncer de próstata metastático resistente à castração (mCRPC) tratados no Brasil usando dados do mundo real de bancos de dados públicos brasileiros. Método: Os casos de câncer de próstata foram filtrados a partir dos registros brasileiros de câncer no período de 2008 a 2018. O número de instituições de saúde que registram esses casos foi usado para separar as Unidades Federativas brasileiras em dois grupos. O número de pacientes com mCRPC foi estimado usando uma combinação de filtros de estadiamento e tratamento (Tx, Nx e M1 + quimioterapia). A idade média e o número e tipos de tratamento realizados foram avaliados. Resultados: O estudo identificou 325.987 pacientes com câncer de próstata e 5.367 com mCRPC. A mediana das idades de pacientes com mCRPC foi de 63 anos. O percentual de pacientes submetidos a um, dois ou três tratamentos foi de 21,0%, 43,2% e 28,1%, respectivamente. Foram observadas diferenças de manejo nos grupos analisados. Conclusão: Os resultados revelaram diferenças regionais nas distribuições de pacientes com mCRPC no território brasileiro e no manejo da doença. Essa informação pode subsidiar decisões de incorporação de novos tratamentos e de melhoria dos cuidados paliativos oferecidos aos pacientes com mCRPC. Este trabalho apresenta sugestões para o desenvolvimento de bancos de dados específicos para câncer de próstata e aprimoramento dos já existentes

Introducción: El cáncer de próstata es el segundo tipo más común en hombres en el mundo. En el Brasil, se espera encontrar diferencias regionales en la incidencia de diagnósticos tardíos de riesgo intermedio y alto. Objetivo: Investigar los perfiles clínico y demográfico de pacientes con cáncer de próstata metastásico resistente a la castración (mCRPC) tratados en el Brasil utilizando datos del mundo real de bases de datos públicas brasileñas. Método: Los casos de cáncer de próstata fueron filtrados a partir de los registros brasileños de cáncer nel período de 2008 a 2018. El número de instituciones registradoras en la base de datos fue utilizado para separar los Estados Brasileños en dos grupos para comparación. El número de pacientes se estimó mediante una combinación de filtros de estadio y tratamiento (Tx, Nx y M1 + quimioterapia). Fueron evaluados la edad media y la cantidad y tipos de tratamiento realizados. Resultados: Se identificaron un total de 325.987 pacientes con cáncer de próstata y 5367 pacientes con mCRPC. La mediana de la edad de los pacientes con mCRPC fue de 63 años. El porcentaje de pacientes sometidos a uno, dos o tres tratamientos fue del 21,0%, 43,2% y 28,1%. Fueron observadas diferencias de manejo según el grupo analizado. Conclusión: Fueron reveladas diferencias regionales en la distribución de los pacientes con mCRPC en el Brasil y, especialmente, en el manejo de la enfermedad a partir de bases de datos públicas. Esta información puede apoyar las decisiones de incorporar nuevos tratamientos y mejorar los cuidados ofrecidos a los pacientes. Se presentan sugerencias para el desarrollo de bases de datos específicas y la mejora de las existentes

Mapeamento dos bancos de dados em dispositivos médicos: revisão narrativa e o cenário brasileiro para avaliação com dados de mundo real (RWD) / Mapping of database in medical devices: review and the Brazilian scenario for evaluation with real world data (RWD)

Objetivo: Pretendeu-se mapear os bancos de dados governamentais em dispositivos médicos, na perspectiva pública com o intuito de contribuir como fonte para gerar dados de mundo real (RWD) e potencial para subsidiar estudos de Avaliação de Tecnologias em Saúde (ATS). Métodos: Realizada revisão narrativa na base de dados do Embase. Os critérios para inclusão de elegibilidade foram: i) dimensão ampla de RDW nos processos de gestão de tecnologias; e ii) aplicação de RDW em processos regulatórios, cobertura e ATS. Também foram consultados os sistemas do Ministério da Saúde e da Anvisa. Resultados: A busca retornou 1.185 resultados; após leitura dos resumos, foram selecionados 29 artigos, sendo 5 incluídos. Na consulta ao catálogo do Datasus, foram localizados 262 sistemas informatizados; após análise da descrição sumária e principais objetivos, foram selecionados 12 sistemas que geram dados sobre dispositivos médicos. A falta de interoperabilidade dos sistemas é recorrente e a ausência de uma nomenclatura padronizada é um desafio a mais. Conclusão: Há crescente discussão do uso de RWD para subsidiar ATS em todo o ciclo de vida tecnológico, desde regulação até monitoramento do uso, como também para subsidiar análises de custo-efetividade e benefícios clínicos. Assim como nos demais países, o Brasil sistematizou inicialmente os dados administrativos para atender às demandas comerciais e financeiras. Os sistemas não geram dados dos resultados clínicos. São disponibilizados dados das tecnologias dispensadas e dos valores repassados e não são coletadas as informações dos benefícios do uso dessas tecnologias. Com a evolução dos métodos de ATS, a utilização de RWD tornou-se relevante.

Objective: It was intended to map government databases on medical devices, in the public perspective, in order to contribute as a source to generate real world data (RWD) and potential to subsidize Health Technology Assessment (HTA) studies. Methods: A narrative review was carried out in the Embase database. The criteria for inclusion of eligibility were: i) broad dimension of RDW in technology management processes; and ii) application of RDW in regulatory processes, coverage and HTA. The systems of the Ministry of Health and Anvisa were also consulted. Results: Results: The search returned 1,185 results, after reading the abstracts, 29 articles were selected, 5 of which were included. The catalog of Datasus database were consulted, 262 summaries with the description and the main objectives were analyzed, 12 systems were selected systems that generate medical devices. The lack of interoperability of systems is recurrent and the absence of a standardized nomenclature is an additional challenge. Conclusion: There is a growing discussion about the use of RWD to subsidize HTA throughout the technological life cycle, from regulation to monitoring of use, as well as to subsidize the examination of cost-effectiveness and clinical benefits. As in other countries, Brazil has systematized administrative data for commercial and financial data demands. The systems do not generate data on clinical outcomes. Data provided are on dispensed technologies, on transferred values and are not collected on the benefits of using these technologies. With the evolution of HTA methods, the use of RWD has become relevant.

Optimization of clinical risk-factor interpretation and radiological findings with machine learning for PIRADS category 3 patients.

BACKGROUND: Due to the low cancer-detection rate in patients with PIRADS category 3 lesions, we created machine learning (ML) models to facilitate decision-making about whether to perform prostate biopsies or monitor clinical information without biopsy results. METHODS: In our retrospective, single-center study, 101 eligible patients with at least one PIRADS category 3 lesion but no higher PIRADS lesions underwent MRI/US fusion biopsies between September 2017 and June 2020. Thirty additional patients were included as the validation cohort from the next chronological period from June 2020 to October 2020. Our ML research was a supervised classification problem, with a binary output based on pathological reports of cancerous or benign tissue. The clinical inputs were age, prostate-specific antigen (PSA), prostate volume, prostate-specific antigen density (PSAD), and the number of previous biopsies. The radiology-report inputs were the number of lesions, maximum lesion diameter, lesion location, and lesion zone. We subsequently removed the inputs with low importance. Logistic Regression, Support Vector Machine, Naive Bayes, Decision Tree, Random Forest, and eXtreme Gradient Boosting Tree (XGBoost) were employed. From receiver operating characteristic (ROC) curves, we determined Area Under the ROC Curve (AUC), the cut-off point, and sensitivity score (recall score) to evaluate the ML-model performance. RESULTS: Twenty-four adenocarcinoma patients had a mean age of 70 ± 5.79 years, a mean PSA of 12.42 ± 6.67 ng/ml, a mean prostate volume of 46.49 ± 23.13 ml, and a mean PSAD of 0.31 ± 0.22 ng/ml2 . Seventy-seven patients with benign tissue reports had a mean age of 66.39 ± 6.66 years, a mean PSA of 11.31 ± 7.50 ng/ml, a mean prostate volume of 65.25 ± 35.88 ml, and a mean PSAD of 0.19 ± 0.13 ng/ml2 . On the validation cohort, XGBoost had the best AUC of 0.76, which considered 80% sensitivity and 72% specificity at a probability cutoff of 57%. The remaining possible ML models performed worse with lesser AUC. The worst was Naïve Bayes, with AUC of 0.50. CONCLUSIONS: ML models facilitate PIRADS 3 patient selection for MRI/US fusion biopsies. ML could optimize how we use previously known clinical risk factors to their full potential.

Correlation between perioperative outcomes and long-term survival for non-small lung cancer treated at major centers.

BACKGROUND: The public is placing increased emphasis on specialty specific rankings, thereby affecting patients' choices of clinical care programs. In the spirit of transparency, public reporting initiatives are underway or being considered by various surgical specialties whose databases rank programs based on short-term outcomes. Of concern, short-term risk avoidance excludes important comparative cases from surgical database participation and may adversely affect overall long-term oncologic treatment team results. To assess the validity of comparing short-term perioperative and long-term survival outcomes of all patients treated at major centers, we studied the correlations between these variables. METHODS: The National Cancer Database was queried for patients diagnosed with non-small cell lung carcinoma (NSCLC) between 2008 and 2012, yielding 5-year follow-up data for all patients at centers treating at least 100 patients annually. Mortality (30- and 90-day), unplanned 30-day readmissions, and hospital length of stay were modeled using logistic regression with sex, race, age, Charlson-Deyo combined comorbidity, extent of surgery, income, insurance status, histology, grade, and analytic stage as predictors, all with 2-way interaction terms. The differences between the predicted rates and observed rates were calculated for each short-term outcome, and the average of these was used to create a short-term metric (STM). A similar approach was used to create a long-term metric (LTM) that used overall survival as a single dependent variable. Centers were ranked into deciles based on these metrics. Visual plotting as well as correlation coefficients were used to judge correlation between STM and LTM. RESULTS: A total of 298,175 patients from 541 centers were included in this analysis, of whom 102,860 underwent surgical resection for NSCLC. The correlation between STM and LTM was negative using parametric estimates (Pearson correlation coefficient = -0.09 [P = .03] and -0.22 [P < .01]) and nonparametric estimates (Spearman rank correlation coefficient = -0.09 [P = .02] and -0.22 [P < .01]) for squamous cell carcinoma and adenocarcinoma, respectively. CONCLUSIONS: Short-term perioperative outcome rankings correlate poorly with long-term survival outcome rankings when cancer treatment centers are compared. Factors explaining this discrepancy merit further study. Rankings based on short-term outcomes alone may be incomplete for public reporting.

Mapeamento dos bancos de dados em dispositivos médicos: revisão narrativa e o cenário brasileiro para avaliação com dados de mundo real (RWD) / Mapping of database in medical devices: review and the Brazilian scenario for evaluation with real world data (RWD)

Objetivo: Pretendeu-se mapear os bancos de dados governamentais em dispositivos médicos, na perspectiva pública com o intuito de contribuir como fonte para gerar dados de mundo real (RWD) e potencial para subsidiar estudos de Avaliação de Tecnologias em Saúde (ATS). Métodos: Realizada revisão narrativa na base de dados do Embase. Os critérios para inclusão de elegibilidade foram: i) dimensão ampla de RDW nos processos de gestão de tecnologias; e ii) aplicação de RDW em processos regulatórios, cobertura e ATS. Também foram consultados os sistemas do Ministério da Saúde e da Anvisa. Resultados: A busca retornou 1.185 resultados; após leitura dos resumos, foram selecionados 29 artigos, sendo 5 incluídos. Na consulta ao catálogo do Datasus, foram localizados 262 sistemas informatizados; após análise da descrição sumária e principais objetivos, foram selecionados 12 sistemas que geram dados sobre dispositivos médicos. A falta de interoperabilidade dos sistemas é recorrente e a ausência de uma nomenclatura padronizada é um desafio a mais. Conclusão: Há crescente discussão do uso de RWD para subsidiar ATS em todo o ciclo de vida tecnológico, desde regulação até monitoramento do uso, como também para subsidiar análises de custo-efetividade e benefícios clínicos. Assim como nos demais países, o Brasil sistematizou inicialmente os dados administrativos para atender às demandas comerciais e financeiras. Os sistemas não geram dados dos resultados clínicos. São disponibilizados dados das tecnologias dispensadas e dos valores repassados e não são coletadas as informações dos benefícios do uso dessas tecnologias. Com a evolução dos métodos de ATS, a utilização de RWD tornou-se relevante.

Mapping community pharmacy services in Brazil: a scoping review

Abstract The delivery of clinical pharmacy services has been growing in Brazilian community pharmacies, and it is necessary to have a comprehensive understanding of the topic. This scoping review aimed to provide an overview of Brazilian studies about clinical pharmacy services in community pharmacies. Original research articles, with no restriction of time, study design, or patient's health condition, were included. Searches were conducted in PubMed, Scopus, Web of Science, Scielo, and Lilacs. Two reviewers conducted the screening, full-text reading, and data extraction independently. ROB and ROBINS-I were used for the assessment of quality. Charts and tables were built to summarise the data. Seventy-two articles were included. A diversity of study designs, number of participants, terms used, and outcomes was found. São Paulo and Sergipe States had the highest number of studies (n=10). Pharmacists' interventions were not fully reported in 65% of studies, and most studies presented an unclear risk of bias. Studies were very diverse, impairing the comparisons between the results and hindering their reproducibility. This review suggests using guidelines and checklists for better structuration of pharmacists' interventions as well as reporting results and measuring fidelity in future research.

Diabetes in the public healthcare sector of four South African provinces: A comparative analysis

The growing burden of diabetes has long been under the radar in developing countries such as South Africa (SA). In recent years, there has been an unprecedented and exponential increase in recorded and undiagnosed diabetes mellitus (DM) cases. Unreliable data collection, overburdened health systems and poor infrastructure have all proved to be barriers to achieving optimum disease management. The District Health Information System (DHIS) serves as the data collection tool for the SA public healthcare sector. It is used in all nine SA provinces to gather data without individual patient identifiers. Objective. To analyse and compare the DM data collected by the DHIS in the Western Cape (WC), Eastern Cape (EC), KwaZulu-Natal (KZN) and Gauteng provinces of SA. Methods. An audit of diabetes-related data from the DHIS for 2016 was conducted. The data were then analysed using Excel. Time-series and cross-sectional analyses were made possible using pivot tables. Graphics were designed using Thinkcell software. Results. Of the four provinces surveyed, Gauteng recorded the highest incidence of DM, 67% higher than the reported global DM incidence estimate, while the WC had the lowest incidence. A similar pattern was also noted regarding the incidence of DM in people aged <18 years, with Gauteng having the highest and WC the lowest prevalence results. When comparing the number of DM-related consultations conducted in each province, the metropolitan districts were highlighted as hotspots of activity for DM care. This study found a moderate inversely proportional relationship between the incidence of DM in all provinces and education deprivation (p<0.05). Among the provinces that collected data on screening (excluding EC), KZN recorded the highest number of diabetic screenings. Conclusion. Metropolitan areas were highlighted as areas to be targeted, further reinforcing the current connection observed between urbanisation and DM in SA. The presence and recording of screening efforts is an excellent step in the right direction for the SA public healthcare sector and the DHIS. With improved interprovincial co-ordination regarding standardisation of the criteria and specifications of data collection fields, and enhanced training for data officers and primary collection agents, good quality and rich data is a very close possibility.

Trial registration and selective outcome reporting in 585 clinical trials investigating drugs for prevention of postoperative nausea and vomiting.

BACKGROUND: Selective outcome reporting in clinical trials introduces bias in the body of evidence distorting clinical decision making. Trial registration aims to prevent this bias and is suggested by the International Committee of Medical Journal Editors (ICMJE) since 2004. METHODS: The 585 randomized controlled trials (RCTs) published between 1965 and 2017 that were included in a recently published Cochrane review on antiemetic drugs for prevention of postoperative nausea and vomiting were selected. In a retrospective study, we assessed trial registration and selective outcome reporting by comparing study publications with their registered protocols according to the 'Cochrane Risk of bias' assessment tool 1.0. RESULTS: In the Cochrane review, the first study which referred to a registered trial protocol was published in 2004. Of all 585 trials included in the Cochrane review, 334 RCTs were published in 2004 or later, of which only 22% (75/334) were registered. Among the registered trials, 36% (27/75) were pro- and 64% (48/75) were retrospectively registered. 41% (11/27) of the prospectively registered trials were free of selective outcome reporting bias, 22% (6/27) were incompletely registered and assessed as unclear risk, and 37% (10/27) were assessed as high risk. Major outcome discrepancies between registered and published high risk trials were a change from the registered primary to a published secondary outcome (32%), a new primary outcome (26%), and different outcome assessment times (26%). Among trials with high risk of selective outcome reporting 80% favoured at least one statistically significant result. Registered trials were assessed more often as 'overall low risk of bias' compared to non-registered trials (64% vs 28%). CONCLUSIONS: In 2017, 13 years after the ICMJE declared prospective protocol registration a necessity for reliable clinical studies, the frequency and quality of trial registration in the field of PONV is very poor. Selective outcome reporting reduces trustworthiness in findings of clinical trials. Investigators and clinicians should be aware that only following a properly registered protocol and transparently reporting of predefined outcomes, regardless of the direction and significance of the result, will ultimately strengthen the body of evidence in the field of PONV research in the future.

Publicly reported health performance measures 2010-2020.

AIM: Performance measurement is central to healthcare management in many countries. The aim of this study was to determine whether performance measurement in a New Zealand healthcare organisation met a range of criteria supported by healthcare management literature. METHOD: Performance expectations published in statements of intent and annual plans from an 11-year period were analysed for evidence of continuity, accuracy, effectiveness, patient centredness and clinical relevance. RESULTS: 731 distinct performance measurements were identified. 48% were measured only once. Of those where comparison was possible, 21.9% met at least one expected target or range. In published reports there was limited reference to data verification methods, tests of significance, prospective linkage to actions, counterbalancing measures, application of benchmarks or standards, or patient measure prioritisation. CONCLUSIONS: These findings suggest that healthcare organisations do not find performance measurement easy. This may be due to the wrong choice of measures, inappropriate targets, incomplete analyses or difficulty in linking measurement results to actions.

Association of Hospital Public Quality Reporting With Electronic Health Record Medication Safety Performance.

Importance: Despite billions spent in public investment, electronic health records (EHRs) have not delivered on the promise of large quality and safety improvement. Simultaneously, there is debate on whether public quality reporting is a useful tool to incentivize quality improvement. Objective: To evaluate whether publicly reported feedback was associated with hospital improvement in an evaluation of medication-related clinical decision support (CDS) safety performance. Design, Settings, and Participants: This nonrandomized controlled trial included US hospitals that participated in the Computerized Provider Order Entry (CPOE) Evaluation Tool in the Leapfrog Hospital Survey, a national quality reporting program that evaluates safety performance of hospital CDS using simulated orders and patients, in 2017 to 2018. A sharp regression discontinuity design was used to identify the association of receiving negative feedback with hospital performance improvement in the subsequent year. Data were analyzed from January through September 2020. Exposures: Publicly reported quality feedback. Main Outcomes and Measures: The main outcome was improvement from 2017 to 2018 on the Leapfrog CPOE Evaluation Tool, using regression discontinuity model estimates of the association of receiving negative publicly reported feedback with quality improvement. Results: A total of 1183 hospitals were included, with a mean (SD) CPOE score of 59.3% (16.3%) at baseline. Hospitals receiving negative feedback improved 8.44 (95% CI, 0.09 to 16.80) percentage points more in the subsequent year compared with hospitals that received positive feedback on the same evaluation. This change was driven by differences in improvement in basic CDS capabilities (ß = 8.71 [95%CI, 1.67 to 18.73]) rather than advanced CDS (ß = 6.15 [95% CI, -9.11 to 26.83]). Conclusions and Relevance: In this nonrandomized controlled trial, publicly reported feedback was associated with quality improvement, suggesting targeted measurement and reporting of process quality may be an effective policy lever to encourage improvement in specific areas. Clinical decision support represents an important tool in ensuring patient safety and decreasing adverse drug events, especially for complex patients and those with multiple chronic conditions who often receive several different drugs during an episode of care.

Reporting of Clinical Outcomes After Endovascular Aortic Aneurysm Repair: A Systematic Review.

BACKGROUND: Endovascular aneurysm repair (EVAR) is an established treatment for many patients with infra-renal abdominal aortic aneurysm (AAA). Reporting standards were published in 2002 to ensure consistent measurement and reporting of outcomes following EVAR. We aimed to assess the range of clinical outcomes reported after EVAR and whether recent studies adhere to established reporting standards. METHODS: We searched MEDLINE and Embase from January 2014 until December 2018, using terms for 'EVAR' and 'AAA'. We included prospective studies and randomised controlled trials which reported clinical outcomes of elective infra-renal AAA repair. Data on clinical outcome reporting were extracted and compared with established reporting standards. RESULTS: 84 studies were included. Technical success was reported in 49 (58.3%) studies, but only defined in 40 (47.6%), with 22 distinct definitions. Clinical success was reported and defined in 19 (22.6%) studies. Aneurysm rupture was reported in 27 (32.1%) studies and death from rupture in 11 (13.1%) studies. All-cause and aneurysm-related mortality were reported in 72 (85.7%) and 52 (61.9%) studies, respectively. Endoleak type I (n = 61, 72.6%) and II (n = 52, 61.9%) were more commonly reported than type III (n = 45, 53.6%) or IV (n = 13, 15.5%). Complications and mortality were reported by a mean of 18 (21.4%) and 42 (50%) studies, respectively. CONCLUSIONS: A wide variety of clinical outcomes were reported following EVAR. Few studies adhered to reporting guidelines. We recommend modification of reporting standards to reflect advances in endovascular technology and creation of a core outcome set for EVAR.

The quality of clinical trials in neuroendocrine tumours; have we learnt from our mistakes? An evaluation of phase II and phase III clinical trials.

The quality and reporting of neuroendocrine tumour (NET) clinical trials has previously been found to be heterogeneous impairing trial interpretability. We aimed to perform an updated review of the quality of phase II/III clinical trials in NET to assess if trial design and reporting have improved since 2011. We performed a PubMed search for phase II/III trials evaluating systemic anticancer therapies or liver-directed therapies published between 2011 and 2018. Data collected comprised administrative data, study population characteristics, endpoints, reporting and statistical design parameters, and results. Sixty studies were included (5218 patients): 50 phase II and 10 phase III trials. Study populations were heterogeneous: 52% of trials allowed tumours from various primary sites, 28% allowed both well- and poorly-differentiated tumour morphology or did not specify, and 57% did not report proliferative indices and/or tumour grade in ≥80% of the study population. Only 36% of trials mandated radiological disease progression on participant enrolment using a validated measure. Statistical design and primary endpoint were clearly defined in 67% and 88% of trials, respectively. Toxicity (88%), radiological response rate (85%) and progression-free survival/time to progression (82%) were well reported in a majority of trials, but health-related quality of life was included in the minority. Of the randomised trials (n = 11), study populations were more homogeneous and study design was more often clearly defined; however, only 45% mandated radiological progression at baseline as measured per Response Evaluation Criteria In Solid Tumours, and reporting of health-related quality of life (55%) remained suboptimal. The design and reporting of NET clinical trials, predominantly of single-arm phase II trials, remains suboptimal and has not considerably improved over time despite the growth in our knowledge of the biology and unique characteristics of NETs. Higher quality is seen in randomised trials, although certain design and reporting elements remain inadequate in some studies. We must prioritise the design and conduct of NET clinical trials to effectively inform future research and guide practice change.