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Fertility and Sterility Jul 2011Clinical trials must be appropriately registered prior to patient enrollment to be considered for publication by most top journals, including Fertility and Sterility.... (Review)
Review
Clinical trials must be appropriately registered prior to patient enrollment to be considered for publication by most top journals, including Fertility and Sterility. Clinical trials involving FDA regulated drugs, whether investigational or already approved, must be registered by law, and summary results must be posted in the registry whether ultimately published or not. This review provides detailed information for authors regarding these requirements and a discussion as to their importance for acceptance of a manuscript and for reviewers to be assured of the integrity of the trial design, execution, and analysis. The accompanying review on study design and statistics is meant to illustrate the difficulties reviewers experience in evaluating a manuscript that does not follow these requirements. The editors of Fertility and Sterility reiterate that clinical trials that have not been registered will not be accepted for review.
Topics: Clinical Trials as Topic; Humans; Registries; Time Factors; World Health Organization
PubMed: 21621769
DOI: 10.1016/j.fertnstert.2011.05.028 -
BMJ (Clinical Research Ed.) Oct 2013To estimate the frequency with which results of large randomized clinical trials registered with ClinicalTrials.gov are not available to the public. (Review)
Review
OBJECTIVE
To estimate the frequency with which results of large randomized clinical trials registered with ClinicalTrials.gov are not available to the public.
DESIGN
Cross sectional analysis
SETTING
Trials with at least 500 participants that were prospectively registered with ClinicalTrials.gov and completed prior to January 2009.
DATA SOURCES
PubMed, Google Scholar, and Embase were searched to identify published manuscripts containing trial results. The final literature search occurred in November 2012. Registry entries for unpublished trials were reviewed to determine whether results for these studies were available in the ClinicalTrials.gov results database.
MAIN OUTCOME MEASURES
The frequency of non-publication of trial results and, among unpublished studies, the frequency with which results are unavailable in the ClinicalTrials.gov database.
RESULTS
Of 585 registered trials, 171 (29%) remained unpublished. These 171 unpublished trials had an estimated total enrollment of 299,763 study participants. The median time between study completion and the final literature search was 60 months for unpublished trials. Non-publication was more common among trials that received industry funding (150/468, 32%) than those that did not (21/117, 18%), P=0.003. Of the 171 unpublished trials, 133 (78%) had no results available in ClinicalTrials.gov.
CONCLUSIONS
Among this group of large clinical trials, non-publication of results was common and the availability of results in the ClinicalTrials.gov database was limited. A substantial number of study participants were exposed to the risks of trial participation without the societal benefits that accompany the dissemination of trial results.
Topics: Access to Information; Cross-Sectional Studies; Publishing; Randomized Controlled Trials as Topic; Registries; Time Factors
PubMed: 24169943
DOI: 10.1136/bmj.f6104 -
BMC Health Services Research Aug 2022Urinary stone disease is a widespread disease with tremendous impact on those affected and on societies around the globe. Nevertheless, clinical and health care research...
BACKGROUND
Urinary stone disease is a widespread disease with tremendous impact on those affected and on societies around the globe. Nevertheless, clinical and health care research in this area seem to lag far behind cardiovascular diseases or cancer. This may be due to the lack of an immediate deadly threat from the disease and therefore less public and professional interest. However, the patients suffer from recurring, sometimes intense pain and often must be treated in hospital. Long-term morbidity includes doubled rates of chronic kidney disease and arterial hypertension after at least one stone-related event. Observational studies, more specifically, registries and other electronic data sets have been proposed as a means of filling critical gaps in evidence. We propose a nationwide digital and fully automated registry as part of the German Ministry for Education and Research (BMBF) call for the "establishment of model registries".
METHODS
RECUR builds on the technical infrastructure of Germany's Medical Informatics Initiative. Local data integration centres (DIC) of participating medical universities will collect pseudonymized and harmonized data from respective hospital information systems. In addition to their clinical data, participants will provide patient reported outcomes using a mobile patient app. Scientific data exploration includes queries and analysis of federated data from DICs of eleven participating sites. All primary patient data will remain at the participating sites at all times. With comprehensive data from this longitudinal registry, we will be able to describe the disease burden, to determine and validate risk factors, and to evaluate treatments. Implementation and operation of the RECUR registry will be funded by the BMBF for five years. Subsequently, the registry is to be continued by the German Society of Urology without significant costs for study personnel.
DISCUSSION
The proposed registry will substantially improve the structural and procedural framework for patients with recurrent urolithiasis. This includes advanced diagnostic algorithms and treatment pathways. The registry will help us identify those patients who will most benefit from specific interventions to prevent recurrences. The RECUR study protocol and the registry's technical architecture including full digitalization and automation of almost all registry-associated proceedings can be transferred to future registries.
TRIAL REGISTRATION
This study is registered at the German Clinical Trial Register (Deutsches Register Klinischer Studien), DRKS-ID DRKS00026923 , date of registration January, 11 2022.
Topics: Humans; Patient Reported Outcome Measures; Recurrence; Registries; Urinary Tract; Urolithiasis
PubMed: 35986287
DOI: 10.1186/s12913-022-08375-7 -
Orphanet Journal of Rare Diseases Sep 2023The European Reference Network for craniofacial anomalies and ear, nose and throat disorders (ERN-CRANIO) aims to improve craniofacial care on a European scale. Within... (Review)
Review
AIM
The European Reference Network for craniofacial anomalies and ear, nose and throat disorders (ERN-CRANIO) aims to improve craniofacial care on a European scale. Within ERN-CRANIO, the cleft lip and palate (CL/P) work stream seeks to ameliorate health outcomes for patients with CL/P. This work stream acknowledged the need for a European wide registry for comparable outcome measures and therapy endpoints to achieve this goal. This review aimed to provide a scientific basis for the conceptualization of this registry by studying previous registry initiatives.
METHODS
This review performed thematic analysis on twenty-four articles through narrative synthesis. An iterative process was used to identify key-themes required for prolonged registry success.
RESULTS
Analysis of the literature resulted in twenty-one distinct headings including quantitative and qualitative data. Quantitative data including registry characteristics were visualized in a table. The analysis of qualitative data resulted in the identification of fourteen key-themes, which have been summarized and visualized in a guidance.
CONCLUSION
This review has successfully identified key-themes required for the development of an international, multidisciplinary, pediatric registry for pan-European cleft care. The guidance provided by this review applies to the goals of ERN-CRANIO, but can be used by any initiative developing a registry.
Topics: Humans; Child; Cleft Lip; Cleft Palate; Registries; Surveys and Questionnaires
PubMed: 37735442
DOI: 10.1186/s13023-023-02901-4 -
Journal of Registry Management 2014The results of a 2001-2005 polycythemia vera (PV) investigation in Eastern Pennsylvania revealed a disease cluster plus underreporting and false reporting to the...
INTRODUCTION
The results of a 2001-2005 polycythemia vera (PV) investigation in Eastern Pennsylvania revealed a disease cluster plus underreporting and false reporting to the Pennsylvania Cancer Registry (PCR).
PURPOSE
The objectives of this study were 1) to assess PV reporting to the PCR in 2006-2009, 2) to determine whether a cancer cluster persisted, and 3) to determine whether other myeloproliferative neoplasms (MPNs), including essential thrombocytopenia (ET), were subject to similar reporting problems.
METHODS
Cases were identified from: 1) PCR records from the Tri-County, 2) reviewing billing records at Tri-County hematologist/oncologist offices, and 3) self-identification. An expert panel of physicians reviewed medical records and determined "true," "false," or "indeterminate" cases reported to the PCR. The analyses were conducted to determine sensitivity and positive predictive value (PPV) of case reporting to the PCR, estimate cancer incidence rates, and evaluate the presence of cancer clusters.
RESULTS
Of 290 cases identified, 90% were from the original PCR, 9% from billing records, and 1% from self-report. Fifty-five cases consented to participate, and medical records were obtained for 44. The expert panel determined that 45% were true cases, 32% were false cases, and 23% were indeterminate. PV had 100% (95% CI, 59-100) sensitivity, but only 47% PPV (95% CI, 20-70): ET had 78% (95% CI, 47-99) sensitivity and 100% PPV (95% CI, 59-100). Low participation and chart review rates led to rates with wide confidence intervals. We did not identify any PV cancer clusters, but we did identify a cluster of 9 ET cases in the Wilkes-Barre, Pennsylvania area.
CONCLUSION
The current study was limited by the low response rate (22%) from MPN patients in the Tri-County area. This study identified 47% PPV for PV reporting and 100% PPV for ET.
Topics: Disease Notification; Humans; Janus Kinase 2; Myeloproliferative Disorders; Pennsylvania; Polycythemia Vera; Public Health Surveillance; Registries; Reproducibility of Results; Research Design
PubMed: 25803630
DOI: No ID Found -
Arquivos Brasileiros de Cardiologia May 2013Several local registries have sought to individually depict clinical characteristics of patients hospitalized with heart failure (HF) in Brazilian hospitals and...
BACKGROUND
Several local registries have sought to individually depict clinical characteristics of patients hospitalized with heart failure (HF) in Brazilian hospitals and communities. Overall, the analysis of these data suggests that there are important differences in etiology, decompensation factors, treatment and prognosis of patients with HF in different Brazilian regions.
OBJECTIVES
To evaluate the demographic, clinical and prognostic characteristics of 1,200 patients admitted with a clinical diagnosis of decompensated HF in a group of 60 hospitals representative of the different Brazilian regions.
METHODS
Transversal observational study (registry) with a longitudinal twelve-month follow-up (admission consultations, hospital discharge, three months, six months and twelve months after inclusion), in which patients admitted to public and private hospitals clinical with a primarily defined HF diagnosis will be studied.
RESULTS
The results will be shown soon after data collection completion, quality assessment and statistical analysis.
CONCLUSIONS
The results of this multicenter registry will allow for a more appropriate planning of financial, technological and personal resource supply for the health care area, as well as the planning of more effective preventive measures in decompensated HF.
Topics: Brazil; Cross-Sectional Studies; Heart Failure; Humans; Multicenter Studies as Topic; Registries
PubMed: 23740432
DOI: 10.5935/abc.20130093 -
The Journal of Prevention of... 2022Disparities in clinical research participation perpetuate broader health disparities. Recruitment registries are novel tools to address known challenges in accrual to...
BACKGROUND
Disparities in clinical research participation perpetuate broader health disparities. Recruitment registries are novel tools to address known challenges in accrual to clinical research. Registries may accelerate accrual, but the utility of these tools to improve generalizability is unclear.
OBJECTIVE
To examine the diversity of a local on-line recruitment registry using the Area Deprivation Index (ADI), a publicly available metric of neighborhood disadvantage.
DESIGN
Retrospective analysis.
SETTING
Data were collected in the University of California Irvine Consent-to-Contact Registry.
PARTICIPANTS
We categorized N=2,837 registry participants based on the ADI decile (collapsed into quintiles) using a state-based rankings.
MEASUREMENTS
We examined the proportion of enrollees per ADI quintile and quantified the demographics of these groups. We assessed willingness to participate in studies involving unique research procedures among the ADI groups.
RESULTS
Although registry enrollees represented the full spectrum of the ADI, they disproportionately represented less disadvantaged neighborhoods (lowest to highest quintiles: 42%, 30%, 15%, 6%, 7%). Compared to participants from less disadvantaged neighborhoods, participants from more disadvantaged neighborhoods were more often female, of non-white race, and Hispanic ethnicity. Despite demographic differences, ADI groups were observed to have similar willingness to participate in research studies.
CONCLUSIONS
People from more disadvantaged neighborhoods may be underrepresented in recruitment registries, increasing the risk that they will be underrepresented when using these tools to facilitate prospective recruitment to clinical research. Once enrolled in registries, participants from more disadvantaged neighborhoods may be equally willing to participate in research. Efforts to increase representation of participants from disadvantaged neighborhoods in registries could be an important first step toward increasing the generalizability of clinical research.
Topics: Female; Humans; Prospective Studies; Quality Indicators, Health Care; Registries; Residence Characteristics; Retrospective Studies
PubMed: 35098982
DOI: 10.14283/jpad.2021.50 -
Asian Pacific Journal of Cancer... Nov 2020This study aims to determine the survival rates for children and adolescents aged 0-19 years diagnosed with childhood cancer and to evaluate the associated factors for...
BACKGROUND
This study aims to determine the survival rates for children and adolescents aged 0-19 years diagnosed with childhood cancer and to evaluate the associated factors for childhood cancer survival in Brunei Darussalam.
METHODS
The analysis was based on de-identified data of 263 childhood cancer for the period 2002 to 2017 retrieved from a population-based cancer registry. Overall survival was estimated using the Kaplan-Meier method. Univariate analysis, using the log-rank test, was used to examine the differences in survival between groups. Multivariate analysis, using the Cox Proportional Hazard (PH) regression model, was used to estimate the hazard ratios (HRs) and select the significant associated factors for childhood cancer patients' survival.
RESULTS
The overall 1-, 5- and 10-year survival rates for all childhood cancers combined were 79.4%, 70.0% and 68.8% respectively. The most common types of cancer were leukemias, malignant epithelial neoplasms, lymphomas and tumours of the central nervous system (CNS). The 5-year survival estimates were highest for malignant epithelial neoplasms (84.2%) while the lowest was tumours of the CNS (44.1%). Log rank tests showed significant differences in childhood cancer patients' survival between tumour types and period of diagnosis. In the Cox PH analysis, the presence of lymphomas, gonodal and germ cell neoplasms, and malignant epithelial neoplasms compared to leukemia; children aged 1-4 and 5-9 years compared to adolescents aged 15-19 years; and periods of diagnosis in 2002-2006 and 2007-2011 compared to 2012-2017 were significantly associated with lower hazard of death in this study.
CONCLUSION
This study provides a baseline measurement of childhood cancer survival for monitoring and evaluation of cancer control programmes, to allow planning of cancer control program strategies such as surveillance, screening, and treatment to improve childhood survival rates in Brunei Darussalam.
Topics: Adolescent; Adult; Brunei; Cancer Survivors; Child; Child, Preschool; Female; Follow-Up Studies; Humans; Infant; Infant, Newborn; Male; Neoplasms; Prognosis; Registries; Retrospective Studies; Survival Rate; Young Adult
PubMed: 33247683
DOI: 10.31557/APJCP.2020.21.11.3259 -
Danish Medical Journal Mar 2023Health registries provide opportunities for conducting large-scale, population-based studies, but attention must be devoted to their specific limitations. Herein, we... (Review)
Review
Health registries provide opportunities for conducting large-scale, population-based studies, but attention must be devoted to their specific limitations. Herein, we describe potential limitations that may affect the validity of registry-based research. Our review includes descriptions of 1) populations, 2) variables, 3) medical coding systems for medical information and 4) selected key methodological challenges. Knowledge of such factors and epidemiological study designs in general is likely to increase the quality of registry-based research and reduce potential biases.
Topics: Humans; Registries; Biomedical Research
PubMed: 36999820
DOI: No ID Found -
BMC Health Services Research Jun 2022The choice of what patient outcomes are included in clinical quality registries is crucial for comparable and relevant data collection. Ideally, a uniform outcome...
BACKGROUND
The choice of what patient outcomes are included in clinical quality registries is crucial for comparable and relevant data collection. Ideally, a uniform outcome framework could be used to classify the outcomes included in registries, steer the development of outcome measurement, and ultimately enable better patient care through benchmarking and registry research. The aim of this study was to compare clinical quality registry outcomes against the COMET taxonomy to assess its suitability in the registry context.
METHODS
We conducted an organizational case study that included outcomes from 63 somatic clinical quality registries in use at HUS Helsinki University Hospital, Finland. Outcomes were extracted and classified according to the COMET taxonomy and the suitability of the taxonomy was assessed.
RESULTS
HUS clinical quality registries showed great variation in outcome domains and in number of measures. Physiological outcomes were present in 98%, resource use in all, and functioning domains in 62% of the registries. Patient-reported outcome measures were found in 48% of the registries.
CONCLUSIONS
The COMET taxonomy was found to be mostly suitable for classifying the choice of outcomes in clinical quality registries, but improvements are suggested. HUS Helsinki University Hospital clinical quality registries exist at different maturity levels, showing room for improvement in life impact outcomes and in outcome prioritization. This article offers an example of classifying the choice of outcomes included in clinical quality registries and a comparison point for other registry evaluators.
Topics: Benchmarking; Humans; Patient Care; Patient Reported Outcome Measures; Registries; Tertiary Healthcare
PubMed: 35729629
DOI: 10.1186/s12913-022-08132-w