Development and evaluation of a customized checklist to assess the quality control of disease registry systems of Tehran, the capital of Iran in 2021.

BACKGROUND: Clinical registries facilitate medical research by providing 'real data'. In the past decade, an increasing number of disease registry systems (DRS) have been initiated in Iran. Here, we assessed the quality control (QC) of the data recorded in the DRS established by Shahid Beheshti University of Medical Sciences in Tehran, the capital city of Iran, in 2021. METHODS: The present study was conducted in two consecutive qualitative and quantitative phases and employed a mixed-method design. A checklist containing 23 questions was developed based on a consensus reached following several panel group discussions, whose face content and construct validities were confirmed. Cronbach's alpha was calculated to verify the tool's internal consistency. Overall, the QC of 49 DRS was assessed in six dimensions, including completeness, timeliness, accessibility, validity, comparability, and interpretability. The seventy percent of the mean score was considered a cut-point for desirable domains. RESULTS: The total content validity index (CVI) was obtained as 0.79, which is a reasonable level. Cronbach's alpha coefficients obtained showed acceptable internal consistency for all of the six QC domains. The data recorded in the registries included different aspects of diagnosis/treatment (81.6%) and treatment quality requirements outcomes (12.2%). According to the acceptable quality cut-point, out of 49 evaluated registries, 48(98%), 46(94%), 41(84%), and 38(77.5%), fulfilled desirable quality scores in terms of interpretability, accessibility, completeness, and comparability, however, 36(73.5%) and 32(65.3%) of registries obtained the quality requirement for timeliness and validity, respectively. CONCLUSION: The checklist developed here, containing customized questions to assess six QC domains of DRSs, provided a valid and reliable tool that could be considered as a proof-of-concept for future investigations. The clinical data available in the studied DRSs fulfilled desirable levels in terms of interpretability, accessibility, comparability, and completeness; however, timeliness and validity of these registries needed to be improved.

Online Health Communities: an alternative feasible data registry tool for developing countries.

Given the many challenges facing healthcare access in many developing countries and the added limitations observed in emergencies like COVID-19 pandemic, the authors here discuss an alternative and feasible approach to overcome all these limitations.

Critical analysis of the literature and standards of reporting on stroke after carotid revascularization.

OBJECTIVE: Mechanisms of procedural stroke after carotid endarterectomy (CEA) or carotid artery stenting are surprisingly underresearched. However, understanding the underlying mechanism could (1) assist in balancing the choice for revascularization vs conservative therapy, (2) assist in choosing either open or endovascular techniques, and (3) assist in taking appropriate periprocedural measures to further decrease procedural stroke rate. The purpose of this study was to overview mechanisms of procedural stroke after carotid revascularization and establish reporting standards to facilitate more granular investigation and individual patient data meta-analysis in the future. METHODS: A systematic review was conducted according to the PRISMA statement. RESULTS: The limited evidence in the literature was heterogeneous and of low quality. Thus, no formal data meta-analysis could be performed. Procedural stroke was classified as hemorrhagic or ischemic; the latter was subclassified as hemodynamic, embolic (carotid embolic or cardioembolic) or carotid occlusion derived, using a combination of clinical inference and imaging data. Most events occurred in the first 24 hours after the procedure and were related to hypoperfusion (pooled incidence 10.2% [95% confidence interval (CI), 3.0-17.5] vs 13.9% [95% CI, 0.0-60.9] after CEA vs carotid artery stenting events, respectively) or atheroembolism (28.9% [95% CI, 10.9-47.0]) vs 34.3 [95% CI, 0.0-91.5]). After the first 24 hours, hemorrhagic stroke (11.6 [95% CI, 5.7-17.4] vs 9.0 [95% CI, 1.3-16.7]) or thrombotic occlusion (18.4 [95% CI, 0.9-35.8] vs 14.8 [95% CI, 0.0-30.5]) became more likely. CONCLUSIONS: Although procedural stroke incidence and etiology may have changed over the last decades owing to technical improvements and improvements in perioperative monitoring and quality control, the lack of literature data limits further statements. To simplify and enhance future reporting, procedural stroke analysis and classification should be documented preemptively in research settings. We propose a standardized form enclosing reporting standards for procedural stroke with a systematic approach to inference of the most likely etiology, for prospective use in registries and randomized controlled trials on carotid revascularization.

The limitations of hospital and law enforcement databases in characterizing the epidemiology of firearm injury.

BACKGROUND: Current data on the epidemiology of firearm injury in the United States are incomplete. Common sources include hospital, law enforcement, consumer, and public health databases, but each database has limitations that exclude injury subgroups. By integrating hospital (inpatient and outpatient) and law enforcement databases, we hypothesized that a more accurate depiction of the totality of firearm injury in our region could be achieved. METHODS: We constructed a collaborative firearm injury database consisting of all patients admitted as inpatients to the regional level 1 trauma hospital (inpatient registry), patients treated and released from the emergency department (ED), and subjects encountering local law enforcement as a result of firearm injury in Jefferson County, Kentucky. Injuries recorded from January 1, 2016, to December 31, 2020, were analyzed. Outcomes, demographics, and injury detection rates from individual databases were compared with those of the combined collaborative database and compared using χ2 testing across databases. RESULTS: The inpatient registry (n = 1,441) and ED database (n = 1,109) were combined, resulting in 2,550 incidents in the hospital database. The law enforcement database consisted of 2,665 patient incidents, with 2,008 incidents in common with the hospital database and 657 unique incidents. The merged collaborative database consisted of 3,207 incidents. In comparison with the collaborative database, the inpatient, total hospital (inpatient and ED), and law enforcement databases failed to include 55%, 20%, and 17% of all injuries, respectively. The hospital captured nearly 94% of survivors but less than 40% of nonsurvivors. Law enforcement captured 93% of nonsurvivors but missed 20% of survivors. Mortality (11-26%) and injury incidence were markedly different across the databases. DISCUSSION: The utilization of trauma registry or law enforcement databases alone do not accurately reflect the epidemiology of firearm injury and may misrepresent areas in need of greater injury prevention efforts. LEVEL OF EVIDENCE: Epidemiological, level IV.

External Validation of Risk Prediction Models to Improve Selection of Patients for Carotid Endarterectomy.

BACKGROUND AND PURPOSE: The net benefit of carotid endarterectomy (CEA) is determined partly by the risk of procedural stroke or death. Current guidelines recommend CEA if 30-day risks are <6% for symptomatic stenosis and <3% for asymptomatic stenosis. We aimed to identify prediction models for procedural stroke or death after CEA and to externally validate these models in a large registry of patients from the United States. METHODS: We conducted a systematic search in MEDLINE and EMBASE for prediction models of procedural outcomes after CEA. We validated these models with data from patients who underwent CEA in the American College of Surgeons National Surgical Quality Improvement Program (2011-2017). We assessed discrimination using C statistics and calibration graphically. We determined the number of patients with predicted risks that exceeded recommended thresholds of procedural risks to perform CEA. RESULTS: After screening 788 reports, 15 studies describing 17 prediction models were included. Nine were developed in populations including both asymptomatic and symptomatic patients, 2 in symptomatic and 5 in asymptomatic populations. In the external validation cohort of 26 293 patients who underwent CEA, 702 (2.7%) developed a stroke or died within 30-days. C statistics varied between 0.52 and 0.64 using all patients, between 0.51 and 0.59 using symptomatic patients, and between 0.49 to 0.58 using asymptomatic patients. The Ontario Carotid Endarterectomy Registry model that included symptomatic status, diabetes, heart failure, and contralateral occlusion as predictors, had C statistic of 0.64 and the best concordance between predicted and observed risks. This model identified 4.5% of symptomatic and 2.1% of asymptomatic patients with procedural risks that exceeded recommended thresholds. CONCLUSIONS: Of the 17 externally validated prediction models, the Ontario Carotid Endarterectomy Registry risk model had most reliable predictions of procedural stroke or death after CEA and can inform patients about procedural hazards and help focus CEA toward patients who would benefit most from it.

Reliability of Trial Information Across Registries for Trials With Multiple Registrations: A Systematic Review.

Importance: Clinical trial registries are important for gaining an overview of ongoing research efforts and for deterring and identifying publication bias and selective outcome reporting. The reliability of the information in trial registries is uncertain. Objective: To assess the reliability of information across registries for trials with multiple registrations. Evidence Review: For this systematic review, 360 protocols of randomized clinical trials (RCTs) approved by research ethics committees in Switzerland, the UK, Canada, and Germany in 2012 were evaluated. Clinical trial registries were searched from March to September 2019 for corresponding registrations of these RCTs. For RCTS that were recorded in more than 1 clinical trial registry, key trial characteristics that should be identical among all trial registries (ie, sponsor, funding source, primary outcome, target sample size, trial status, date of first patient enrollment, results available, and main publication indexed) were extracted in duplicate. Agreement between the different trial registries for these key characteristics was analyzed descriptively. Data analyses were conducted from May 1 to November 30, 2020. Representatives from clinical trial registries were interviewed to discuss the study findings between February 1 and March 31, 2021. Findings: The analysis included 197 RCTs registered in more than 1 trial registry (151 in 2 registries and 46 in 3 registries), with 188 trials in ClinicalTrials.gov, 185 in the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT), 20 in ISRCTN, and 47 in other registries. The agreement of key information across all registries was as follows: 178 of 197 RCTs (90%; 95% CI, 85%-94%) for sponsor, 18 of 20 (90%; 95% CI, 68%-99%) for funding source (funding was not reported on ClinicalTrials.gov), 154 of 197 (78%; 95% CI, 72%-84%) for primary outcome, 90 of 197 (46%; 95% CI, 39%-53%) for trial status, 122 of 194 (63%; 95% CI, 56%-70%) for target sample size, and 43 of 57 (75%; 95% CI, 62%-86%) for the date of first patient enrollment when the comparison time was increased to 30 days (date of first patient enrollment was not reported on EudraCT). For results availability in trial registries, agreement was 122 of 197 RCTs (62%; 95% CI, 55%-69%) for summary data reported in the registry and 91 of 197 (46%; 95% CI, 39%-53%) for whether a published article with the main results was indexed. Different legal requirements were stated as the main reason for inconsistencies by representatives of clinical trial registries. Conclusions and Relevance: In this systematic review, for a substantial proportion of registered RCTs, information about key trial characteristics was inconsistent across trial registries, raising concerns about the reliability of the information provided in these registries. Further harmonization across clinical trial registries may be necessary to increase their usefulness.

Validation of testicular germ cell tumor staging in nationwide cancer registries.

INTRODUCTION: Nationwide cancer registries such as the National Cancer Database and Surveillance, Epidemiology, and End Results rely on accurate data from tumor registries to formulate hypotheses and report outcomes and treatment patterns. We evaluated the accuracy of our institutional registry for testicular germ cell tumors by comparing data abstracted by urologists with data abstracted by registry. METHODS: We performed a retrospective review of patients receiving initial diagnosis and treatment for germ cell tumors at our hospital system from 2005 to 2016. We compared coding for American Joint Committee on Cancer TNMS staging, overall composite stage, and first-line treatment between urologists and tumor registry at the time of diagnosis. RESULTS: Paired staging from registry and urologist was available for 80 patients. T, N, M, and S-staging were accurate for 90%, 81%, 94%, and 54% of records, respectively. Composite staging and first-line treatment were concordant for 39% and 90% of patients, respectively. A separate review of 33 Stage IS patients per registry for composite staging revealed 15% concordance. CONCLUSION: Our institutional tumor registry had substantial inconsistencies in accurately staging N stage, S stage, and thus, composite stage for testicular cancer. An educational intervention to improve abstraction by registry led to increased concordance. Assuming similar discrepancies may exist at other institutions and for other cancer types, caution should be used when interpreting staging data in nationwide cancer registries. This sheds light on the need for improved clarification of staging guidelines, dynamic institutional internal auditing, and training reform within cancer registries.

Does the National Immunisation Register stack up? Quantifying accuracy when compared to parent-held health record books.

AIM: The National Immunisation Register (NIR), which is derived from general practice management systems, is an important tool for the provision of clinical services, national immunisation programme evaluation and immunisation research in New Zealand. However, the accuracy of the NIR data has not yet been quantified. This study aimed to examine, describe and quantify the extent of discrepancy in the NIR compared to Well Child Tamariki Ora parent-held health record books (Health Books). METHOD: Immunisation data for vaccinations given between birth and four years old for children born between 2006 and 2019 were compared between the Health Books and the NIR. Health Book records were used as the reference standard to calculate performance measures: sensitivity, specificity, positive and negative predictive values for the NIR. RESULTS: Overall, NIR performance was high: sensitivity ranged from 90% to 93%, specificity from 78% to 85%, the positive predictive value from 91% to 94% and the negative predictive value from 77% to 84%. NIR performance was higher for National Immunisation Schedule (NIS) vaccines compared with non-NIS vaccines. CONCLUSION: This study indicates the NIR data accuracy generally performs well compared with international equivalents, especially for NIS vaccine records. Further work is required to ascertain why discrepancies between the Health Books and NIR continue to occur, with particular attention to important subgroups and translating records across from migrant populations. Also, future work is required to understand the accuracy of vaccination records for groups who experience lower-quality healthcare and a higher burden of infectious diseases.

Region-wise analysis of dairy cow movements in Japan.

BACKGROUND: Animal movement is considered the most significant factor in the transmission of infectious diseases in livestock. A better understanding of its effects would help provide a more reliable estimation of the disease spread and help develop effective control measures. If the movement pattern is heterogeneous, its characteristics should be considered in epidemiological analyses, such as when using simulation models to obtain reliable outputs. In Japan, following the bovine spongiform encephalopathy epidemic, a traceability system for cattle was established in 2003, and the registration of all cattle movements in the national database began. This study is the first to analyze cattle movements in Japan. We examined regional and seasonal heterogeneity in dairy cow movements, which accounted for most Japanese breeding cattle. RESULTS: In the 14 years from April 2005 to March 2018, 4,577,709 between-farm movements of dairy cows were recorded, and the number of movements was counted by month and age for both inter- and intra-regional movements. As a result, two characteristic round-trip movements were observed: one was non-seasonal and inter-regional movements related to cattle-breeding ranches in Hokkaido (the northern region of Japan), which consists of the movement of cows around ages 6 to 8 and 21 to 23 months old. In addition, the seasonal movement of heifers for summer grazing within Hokkaido occurred in May and October at the peak ages of 13 to 14 and 19 to 20 months old, respectively. The observed heterogeneity seemed to reflect the suitability of raising the Holstein breed in Hokkaido and the shortage of supply of replacement heifers and available farming areas outside Hokkaido. CONCLUSIONS: Understanding the patterns of dairy cow movements will help develop reliable infectious disease models and be beneficial for developing effective control measures against these diseases.

Have inequalities in completeness of death registration between states in India narrowed during two decades of civil registration system strengthening?

BACKGROUND: In India the number of registered deaths increased substantially in recent years, improving the potential of the civil registration and vital statistics (CRVS) system to be the primary source of mortality data and providing more families of decedents with the benefits of possessing a death certificate. This study aims to identify whether inequalities in the completeness of death registration between states in India, including by sex, have narrowed during this period of CRVS system strengthening. METHODS: Data used in this study are registered deaths by state and year from 2000 to 2018 (and by sex from 2009 to 2018) reported in the Civil Registration Reports published by the Office of Registrar General of India. Completeness of death registration is calculated using the empirical completeness method. Levels and trends inequalities in completeness are measured in each state a socio-economic indicator - the Socio-Demographic Index (SDI). RESULTS: Estimated completeness of death registration in India increased from 58% in 2000 to 81% in 2018. Male completeness rose from 60% in 2009 to 85% in 2018 and was much higher than female completeness, which increased from 54 to 74% in the same period. Completeness remained very low in some states, particularly from the eastern (e.g. Bihar) and north-eastern regions. However, in states from the northern region (e.g. Uttar Pradesh) completeness increased significantly from a low level. There was a narrowing of inequalities in completeness according to the SDI during the period, however large inequalities between states remain. CONCLUSIONS: The increase in completeness of death registration in India is a substantial achievement and increases the potential of the death registration system as a routine source of mortality data. Although narrowing of inequalities in completeness demonstrates that the benefits of higher levels of death registration have spread to relatively poorer states of India in recent years, the continued low completeness in some states and for females are concerning. The Indian CRVS system also needs to increase the number of registered deaths with age at death reported to improve their usability for mortality statistics.

The Gold Coast criteria increases the diagnostic sensitivity for amyotrophic lateral sclerosis in a Chinese population.

OBJECTIVES: The aim of this study was to assess and compare the diagnostic utility of a new diagnostic criteria for amyotrophic lateral sclerosis (ALS), abbreviated as the 'Gold Coast Criteria', with the revised El Escorial (rEEC) and Awaji criteria. METHODS: Clinical and electrophysiological data of 1185 patients from January 2014 to December 2019 in the Peking Union Medical College Hospital ALS database were reviewed. The sensitivity of the Gold Coast criteria was compared to that of the possible rEEC and Awaji criteria (defined by the proportion of patients categorized as definite, probable, or possible ALS). RESULTS: A final diagnosis of ALS was recorded in 1162 patients. The sensitivity of the Gold Coast criteria (96.6%, 95% confidence interval [CI] = 95.3%-97.5%) was greater than that of the rEEC (85.1%, 95%CI = 82.9%-87.1%) and Awaji (85.3%, 95%CI = 83.2%-87.3%). In addition, the sensitivity of the novel criteria maintained robust across subgroups, and the advantage was more prominent in limb-onset ALS patients and those who completed electromyographic tests. In those who did not achieve any of the rEEC diagnostic categories, the sensitivity of Gold Coast criteria was 84.4%. CONCLUSIONS: The current study demonstrated that the Gold Coast criteria exhibited greater diagnostic sensitivity than the rEEC and Awaji criteria in a Chinese ALS population. The application of the Gold Coast criteria should be considered in clinical practice and future therapeutic trials.

Reweighting a Swedish health questionnaire survey using extensive population register and self-reported data for assessing and improving the validity of longitudinal associations.

BACKGROUND: In cohorts with voluntary participation, participants may not be representative of the underlying population, leading to distorted estimates. If the relevant sources of selective participation are observed, it is however possible to restore the representativeness by reweighting the sample to resemble the target population. So far, few studies in epidemiology have applied reweighting based on extensive register data on socio-demographics and disease history, or with self-reported data on health and health-related behaviors. METHODS: We examined selective participation at baseline and the first two follow-ups of the Scania Public Health Cohort (SPHC), a survey conducted in Southern Sweden in 1999/2000 (baseline survey; n = 13,581 participants, 58% participation rate), 2005 (first follow-up, n = 10,471), and 2010 (second follow-up; n = 9,026). Survey participants were reweighted to resemble the underlying population with respect to a broad range of socio-demographic, disease, and health-related characteristics, and we assessed how selective participation impacted the validity of associations between self-reported overall health and dimensions of socio-demographics and health. RESULTS: Participants in the baseline and follow-up surveys were healthier and more likely to be female, born in Sweden, middle-aged, and have higher socioeconomic status. However, the differences were not very large. In turn, reweighting the samples to match the target population had generally small or moderate impacts on associations. Most examined regression coefficients changed by less than 20%, with virtually no changes in the directions of the effects. CONCLUSION: Overall, selective participation with respect to the observed factors was not strong enough to substantially alter the associations with self-assessed health. These results are consistent with an interpretation that SPHC has high validity, perhaps reflective of a relatively high participation rate. Since validity must be determined on a case-by-case basis, however, researchers should apply the same method to other health cohorts to assess and potentially improve the validity.

The impact of incomplete registration on survival rate of children with very rare tumors.

Pediatric very rare tumors (VRTs) represent a heterogeneous subset of childhood cancers, with reliable survival estimates depending dramatically on each (un)registered case. The current study aimed to evaluate the number of VRTs among Lithuanian children, to assess the impact of the registration status on survival rates and to track changes in treatment outcomes over the 16-year study period. We performed a population-based retrospective study across children below 18 years old diagnosed with VRTs in Lithuania between the years 2000 and 2015. The identified cases were cross-checked with the Lithuanian Cancer Registry-a population-based epidemiology cancer registry-for the fact of registration and survival status. The overall survival was calculated in relation to the registration status and treatment period. Thirty-seven children with VRTs were identified within the defined time frame. Six of them (16.2%) were not reported to the Lithuanian Cancer Registry at diagnosis. The probability of overall survival at 5 years (OS5y) differed significantly between the registered (n = 31) and unregistered (n = 6) cohorts: 51.6% versus 100%, respectively (p = 0.049). A 5-year survival estimate for children diagnosed with a VRT at the age of 0-14 years differed by 10 percentage points according to the registration completeness: 52.1% calculated for the entire cohort versus 42.1% for registered patients only. The OS5y has not improved over the analyzed period: 61.1% in 2000-2007 versus 57.9% in 2008-2015 (p = 0.805). The survival continued to decline beyond 5 years post-diagnosis due to late cancer-related adverse events: 59.5% of patients were alive at 5 years as compared to 44.3% at 10 years. The OS5y of children affected by VRT was lower than in more common childhood cancers. The survival rate of the unregistered patients may lead to misinterpretation of treatment outcomes. Meticulous registration of VRTs is crucial for correct evaluation of treatment outcomes, especially across small countries with few cases.

Validation and minimum important difference of the UCSD Shortness of Breath Questionnaire in fibrotic interstitial lung disease.

RATIONALE: The University of California, San Diego Shortness of Breath Questionnaire (UCSDSOBQ) is a frequently used domain-specific dyspnea questionnaire; however, there is little information available regarding its use and minimum important difference (MID) in fibrotic interstitial lung disease (ILD). We aimed to describe the key performance characteristics of the UCSDSOBQ in this population. METHODS: UCSDSOBQ scores and selected anchors were measured in 1933 patients from the prospective multi-center Canadian Registry for Pulmonary Fibrosis. Anchors included the St. George's Respiratory Questionnaire (SGRQ), European Quality of Life 5 Dimensions 5 Levels questionnaire (EQ-5D-5L) and EQ visual analogue scale (EQ-VAS), percent-predicted forced vital capacity (FVC%), diffusing capacity of the lung for carbon monoxide (DLCO%), and 6-min walk distance (6MWD). Concurrent validity, internal consistency, ceiling and floor effects, and responsiveness were assessed, followed by estimation of the MID by anchor-based (linear regression) and distribution-based methods (standard error of measurement). RESULTS: The UCSDSOBQ had a high level of internal consistency (Cronbach's alpha = 0.97), no obvious floor or ceiling effect, strong correlations with SGRQ, EQ-5D-5L, and EQ-VAS (|r| > 0.5), and moderate correlations with FVC%, DLCO%, and 6MWD (0.3 < |r| < 0.5). The MID estimate for UCSDSOBQ was 5 points (1-8) for the anchor-based method, and 4.5 points for the distribution-based method. CONCLUSION: This study demonstrates the validity of UCSDSOBQ in a large and heterogeneous population of patients with fibrotic ILD, and provides a robust MID estimate of 5-8 points.

Evaluation of data quality in the Spanish EURECCA Esophagogastric Cancer Registry.

BACKGROUND: Although the number of nationwide clinical registries in upper gastrointestinal cancer is increasing, few of them perform regular clinical audits. The Spanish EURECCA Esophagogastric Cancer Registry (SEEGCR) was launched in 2013. The aim of this study was to assess the reliability of the data in terms of completeness and accuracy. METHODS: Patients who were registered (2014-2017) in the online SEEGCR and underwent esophagectomy or gastrectomy with curative intent were selected for auditing. Independent teams of surgeons visited each center between July 2018 and December 2019 and checked the reliability of data entered into the registry. Completeness was established by comparing the cases reported in the registry with those provided by the Medical Documentation Service of each center. Twenty percent of randomly selected cases per hospital were checked during on-site visits for testing the accuracy of data (27 items per patient file). Correlation between the quality of the data and the hospital volume was also assessed. RESULTS: Some 1839 patients from 19 centers were included in the registry. The mean completeness rate in the whole series was 97.8% (range 82.8-100%). For the accuracy, 462 (25.1%) cases were checked. Out of 12,312 items, 10,905 were available for verification, resulting in a perfect agreement of 95% (87.1-98.7%). There were 509 (4.7%) incorrect and 35 (0.3%) missing entries. No correlation between hospital volume and the rate of completeness and accuracy was observed. CONCLUSIONS: Our results indicate that the SEEGCR contains reliable data.