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The Journal of Surgical Research Aug 2023Clinical trial registry searches for unpublished clinical trial data are a means of mitigating publication bias within systematic reviews (SRs). The purpose of our study... (Review)
Review
INTRODUCTION
Clinical trial registry searches for unpublished clinical trial data are a means of mitigating publication bias within systematic reviews (SRs). The purpose of our study is to look at the rate of clinical trial registry searches conducted by SRs in the top five Plastic and Reconstructive Surgery journals.
METHODS
We identified the top five plastic and reconstructive surgery journals using the Google h-5 index. We then searched Pubmed for SRs published in these journals and compared them to plastic surgery SRs published in the Cochrane Collaboration for SRs over the last 5 y. We included all SRs that were published within these top five journals and Cochrane between December 6, 2016 and December 6, 2021. We then conducted a secondary analysis on clinicaltrials.gov looking for unpublished clinical trials for 100 randomized SRs that did not conduct a clinical trial registry search.
RESULTS
In SRs, 3.3% (17/512) from plastic surgery journals conducted trial registry searches. In comparison, 95.0% (38/40) of Cochrane Collaboration SRs conducted trial registry searches. Our secondary analysis found that 50% (50/100) of SRs could have included at least one unpublished clinical trial data set.
CONCLUSIONS
We found that plastic surgery SRs rarely include searches for unpublished clinical trial data in clinical trial registries. To improve the data completeness of SRs in plastic surgery journals, we recommend journals alter their author guidelines to require a clinical trial registry search for unpublished literature.
Topics: Surgery, Plastic; Publication Bias; Epidemiologic Studies; Plastic Surgery Procedures; Registries
PubMed: 36948029
DOI: 10.1016/j.jss.2023.02.022 -
Journal of Plastic, Reconstructive &... Jun 2022To improve the safety and early detection of unexpected breast implant-related complications, the Korean Breast Implant Registry (K-BIR) was launched in 2020 in...
BACKGROUND
To improve the safety and early detection of unexpected breast implant-related complications, the Korean Breast Implant Registry (K-BIR) was launched in 2020 in cooperation with the Korean Society of Plastic and Reconstructive Surgeons and the Korean Ministry of Food and Drug Safety, and a pilot study was conducted.
OBJECTIVE
This article provides an overview of our pilot study and experiences of the K-BIR.
METHODS
The dataset to be used in the pilot form of K-BIR was constructed by holding online surveys and meetings focusing on the global breast device registry's minimum dataset. A pilot study was implemented from April 1, 2020, to July 31, 2020, with six university teaching hospitals and four private clinics.
RESULTS
During the pilot study period, 325 patients, 451 procedures, and 366 implants were entered into the K-BIR. The most common procedure registered was augmentation mammaplasty (30%) for cosmetic indications, followed by direct-to-implant breast reconstruction (27%). Smooth silicone implant was the most common type (73%) of implant used. A feedback survey after the pilot study included questions about the registration rate compared with an actual procedure, entry time, reasons for difficulty in entry, and additional data needed.
CONCLUSIONS
The continuous maintenance and development of K-BIR will require an effective dataset, a strengthened legal system for an opt-out registry and personal data protection, various incentives for increasing participation rates, and an electronic platform that patients, manufacturers, and clinicians can easily access. K-BIR has the potential to provide quality assurance and outcomes for research and post-market surveillance systems for breast implants as well as methods for enhancing patient safety.
Topics: Breast Implantation; Breast Implants; Female; Humans; Mammaplasty; Pilot Projects; Postoperative Complications; Registries; Republic of Korea
PubMed: 35151594
DOI: 10.1016/j.bjps.2022.01.024 -
Nature Reviews. Clinical Oncology Mar 2011Tumor biomarker studies may generate insights into the biological characteristics that drive the clinical behavior of a cancer. Publication bias and hidden multiple... (Review)
Review
Tumor biomarker studies may generate insights into the biological characteristics that drive the clinical behavior of a cancer. Publication bias and hidden multiple hypotheses testing distort the assessment of the true value of biomarkers. Publication bias from preferential reporting of 'positive' findings is well recognized. Hidden multihypothesis testing arises from several biomarkers being tested by different teams using the same samples. The more hypotheses (that is, biomarker association with outcome) tested, the greater the risk of false-positive findings. These biases inflate the potential clinical validity and utility of published biomarkers while negative results often remain hidden. Trial registries have been developed where all phase II and phase III trials should be listed regardless of study outcome. However, such steps have not been taken to reduce such bias in tumor biomarker research. We propose that a registry should be created for biomarker studies initially focused on studies that use specimens from randomized trials. Further development could include nonrandomized studies and deposition of raw data similar to existing genomic data repositories. The benefits of a comprehensive biomarker study registry include more balanced evaluation of proposed markers, fewer false positive leads in research, and hopefully more rapid identification of promising candidate biomarkers.
Topics: Biomarkers, Tumor; Humans; Neoplasms; Registries
PubMed: 21364690
DOI: 10.1038/nrclinonc.2011.4 -
Journal of Clinical Epidemiology Jan 2018
Topics: Humans; Registries; Research Design; Systematic Reviews as Topic
PubMed: 28951107
DOI: 10.1016/j.jclinepi.2017.09.016 -
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 -
Inflammatory Bowel Diseases Nov 2017There are different types of large registries which can be harnessed for inflammatory bowel disease research. Not one registry can answer all types of research... (Review)
Review
There are different types of large registries which can be harnessed for inflammatory bowel disease research. Not one registry can answer all types of research questions. It is important for both the researchers using the registries and readers of the reports generated, to be aware of the different strengths and weaknesses of each registry and whether the questions posed can reliably be answered. In this review, the use of large administrative databases/registries are discussed in the context of studying descriptive epidemiology, outcomes of inflammatory bowel disease, pharmacoepidemiology, and etiologic research.
Topics: Databases, Factual; Humans; Inflammatory Bowel Diseases; Registries
PubMed: 28991858
DOI: 10.1097/MIB.0000000000001279 -
EMBO Reports Jan 2020EMBO Press encourages to document or pre-register animal experiments on the new Animal Study Registry to increase reproducibility and efficacy of animal research.
EMBO Press encourages to document or pre-register animal experiments on the new Animal Study Registry to increase reproducibility and efficacy of animal research.
Topics: Animal Experimentation; Animals; Registries; Reproducibility of Results
PubMed: 31867857
DOI: 10.15252/embr.201949868 -
The Journal of Surgical Research Mar 2020To determine the extent to which systematic reviews published in surgery journals reported a clinical trial registry search as part of their search strategy and whether...
OBJECTIVE
To determine the extent to which systematic reviews published in surgery journals reported a clinical trial registry search as part of their search strategy and whether systematic reviews that omitted such searches would have located additional trials for inclusion.
BACKGROUND
Systematic reviews are used by clinicians to guide clinical decision making. When conducting systematic reviews, the comprehensive search strategy is particularly critical to identify all studies-whether published or not-for producing an overall summary effect. Inclusion of only published studies may lead to overestimated and inaccurate summary effects; thus, it is important to consider unpublished studies. Here, we investigate the extent of clinical trial registry searches performed in surgical systematic reviews because trial registries may be the most viable approach to locate unpublished trial data.
METHODS
We retrieved systematic reviews from the top surgery journals and the Cochrane Collaboration. Each was reviewed to determine which bibliographic databases were used and which, if any, trial registries were searched.
RESULTS
Of 996 total systematic reviews, 252 (25.3%) reported having included a clinical trial registry search, with systematic reviews published in journals reporting searches of unpublished research at a rate of 6.4% (47/737). Reviews published by the Cochrane Collaboration included searches of unpublished research 79.2% of the time (205/259).
CONCLUSIONS
Many systematic reviews published in surgery journals include only published research, which may contribute to publication bias. We recommend that authors maximize available information by using unpublished trial data found in clinical trial registries.
Topics: Clinical Trials as Topic; Cross-Sectional Studies; General Surgery; Meta-Analysis as Topic; Publication Bias; Registries; Systematic Reviews as Topic
PubMed: 31708197
DOI: 10.1016/j.jss.2019.09.067 -
Contemporary Clinical Trials Aug 2022Clinical registries have become an important platform for performance measurement, quality improvement, and clinical research including registry-based randomised... (Review)
Review
BACKGROUND
Clinical registries have become an important platform for performance measurement, quality improvement, and clinical research including registry-based randomised controlled trials (RRCTs). However, the success of RRCTs is highly dependent on the quality of the registry. The aim of this study was to undertake a scoping review to identify the key characteristics that a registry must possess to be considered of high quality to successfully support the conduct of a RRCT.
METHODS
A comprehensive search of four databases and grey literature was conducted. A narrative synthesis was conducted with a focus on summarising the characteristics that a high-quality registry must possess to support the conduct of RRCTs, and the mechanisms underpinning the collection of high-quality data.
RESULTS
A total of 50 articles were included. Data accuracy, completeness, population capture, data standardisation, and timeliness were identified as essential data attributes of a high-quality clinical registry. The legal and ethical environment in which a registry operates, the available infrastructure support, and ongoing participation by healthcare providers were identified as impacting the collection of high-quality data.
CONCLUSIONS
This review summarises the considerable work undertaken to determine the criteria with which to judge the suitability of a clinical registry to support a RRCT. Moving forward, the certification of individual clinical registries may be one way of identifying registries that can support a RRCT. In the interim, we propose the Registry Attributes Framework which can be used to ascertain the suitability of a registry to support a RRCT. Ultimately, the ideal goal should be to define minimum acceptable standards for a registry's key performance indicators (as depicted in the Framework) that would determine its certification status. New registries planned to support a RRCT should be designed and constructed against agreed standards once these are established.
Topics: Data Accuracy; Databases, Factual; Humans; Quality Improvement; Randomized Controlled Trials as Topic; Registries
PubMed: 35792338
DOI: 10.1016/j.cct.2022.106843 -
Brain and Nerve = Shinkei Kenkyu No... Nov 2014Remudy (Registry of Muscular Dystrophy), operated by NCNP (the National Center of Neurology and Psychiatry), Japan, runs two national registries for Dystrophinopathy and... (Review)
Review
Remudy (Registry of Muscular Dystrophy), operated by NCNP (the National Center of Neurology and Psychiatry), Japan, runs two national registries for Dystrophinopathy and GNE myopathy in collaboration with the TREAT-NMD (Translational Research in Europe--Assessment and Treatment of Neuromuscular Disease) alliance. The aim of Remudy is to construct a clinical research infrastructure that accelerates the pace of clinical development research for these rare diseases. We successfully provide data sets for feasibility studies, send out appropriate information about clinical trials to speed up the recruitment of candidates, as well as present the natural history and epidemiology data of these rare diseases using a new 'registry based' research style. Remudy presents a prototype model of the clinical research infrastructure to overcome these rare and incurable diseases.
Topics: Biomedical Research; Cooperative Behavior; Europe; Humans; Japan; Muscular Dystrophies; Registries; Translational Research, Biomedical
PubMed: 25407075
DOI: 10.11477/mf.1416200045