The use of study registration and protocols in plastic surgery research: A systematic review

Pidgeon, Thomas E.; Limb, Christopher; Agha, Riaz; Whitehurst, Katharine; Chandrakumar, Charmilie; Wellstead, Georgina; Fowler, Alexander J.; Orgill, Dennis P.

doi:10.1016/j.ijsu.2017.06.035

Cited by 9 publications

(7 citation statements)

References 18 publications

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“… 8 , 177 , 179 The reporting of protocols, publishing protocols, and registering studies is an important step in robust medical research. 180 They not only allow independent peer review of the study at hand, which allows improvements in study methodology, but also ensure complete transparency in differences between the protocol and the final study. 180 Moreover, protocol registration may help prevent study duplication, in which researchers are able to access databases to ascertain whether there are similar studies in progress.…”

Section: Discussionmentioning

confidence: 99%

“… 180 They not only allow independent peer review of the study at hand, which allows improvements in study methodology, but also ensure complete transparency in differences between the protocol and the final study. 180 Moreover, protocol registration may help prevent study duplication, in which researchers are able to access databases to ascertain whether there are similar studies in progress. 181 Assessments of risk of bias within individual studies and across studies such as missing studies (known as publication bias) and missing data in included studies (known as selective reporting bias) are also important because if results are missed, it can lead to in overestimation or underestimation of treatment effects.…”

Section: Discussionmentioning

confidence: 99%

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Assessing the compliance of systematic review articles published in leading dermatology journals with the PRISMA statement guidelines: A systematic review

et al. 2020

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Background: Reporting quality of systematic reviews and meta-analyses is of critical importance in dermatology because of their key role in informing health care decisions. Objective: To assess the compliance of systematic reviews and meta-analyses in leading dermatology journals with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement guidelines. Methods: This review was carried out in accordance with PRISMA guidelines. Included studies were reviews published across 6 years in the top 4 highest-impact-factor dermatology journals of 2017. Records and full texts were screened independently. Data analysis was conducted with univariate multivariable linear regression. The primary outcome was to assess the compliance of systematic reviews and metaanalyses in leading dermatology journals with the PRISMA statement. Results: A total of 166 studies were included and mean PRISMA compliance across all articles was 73%. Compliance significantly improved over time (b = .016; P = \.001). The worst reported checklist item was item 5 (reporting on protocol existence), with a compliance of 15% of articles. Conclusion: PRISMA compliance within leading dermatology journals could be improved; however, it is steadily improving.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Assessing the compliance of systematic review articles published in leading dermatology journals with the PRISMA statement guidelines: A systematic review

et al. 2020

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“…The Declaration of Helsinki (World Medical Association https://www.wma.net/what-we-do/medic al-ethic s/decla ratio n-of-helsi nki/) states that research involving human subjects must have a protocol that is registered in a publicly accessible database before the recruitment of the first patient (Pidgeon et al, 2017;World Medical Association, 2013). Similarly, the protocol of a systematic review must be prepared and registered prior to conducting the review, rather than during the review process (Abuabara et al, 2019).…”

Section: International Endodontic Journal Policy On Mandatory Prospec...mentioning

confidence: 99%

InternationalEndodonticJournal policy on mandatory prospective (a priori) protocol registration for clinical trials and systematic reviews

2021

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“…Clinical trials are registered to facilitate oversight and scrutiny, and these public registries provide an opportunity to closely examine the body of work that is being conducted. 8 ClinicalTrials.gov is a registry consisting of nearly 350,000 clinical research studies, making it the most robust clinical trial registry in the world and the registry representing most plastic surgery clinical trials. Using this publicly available information, we identified all trials that were relevant to PRS within the database and analyzed characteristics of these trials to better understand the research and funding landscape of all PRS clinical trials.…”

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confidence: 99%

Characterizing Clinical Trials in Plastic and Reconstructive Surgery

Cai

Patel

Thirunavu³

et al. 2023

Ann Plast Surg

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Background Clinical trials form the backbone of evidence-based medicine. ClinicalTrials.gov is the world's largest clinical trial registry, and the state of clinical trials in plastic and reconstructive surgery (PRS) within that database has not been comprehensively studied. To that end, we explored the distribution of therapeutic areas that are under investigation, impact of funding on study design and data reporting, and trends in research patterns of all PRS interventional clinical trials registered with ClinicalTrials.gov. Methods Using the ClinicalTrials.gov database, we identified and extracted all clinical trials relevant to PRS that were submitted between 2007 and 2020. Studies were classified based on anatomic locations, therapeutic categories, and specialty topics. Cox proportional hazard was used to calculate adjusted hazard ratios (HRs) for early discontinuation and results reporting. Results A total of 3224 trials that included 372,095 participants were identified. The PRS trials grew at an annual rate of 7.9%. The therapeutic classes most represented were wound healing (41.3%) and cosmetics (18.1%). Funding for PRS clinical trials is largely provided through academic institutions (72.7%), while industry and US government constituted a minority. Industry-funded studies were more likely to be discontinued early than those funded by academics (HR, 1.89) or government (HR, 1.92) and to be nonblinded and nonrandomized. Academic-funded studies were the least likely to report results data within 3 years of trial completion (odds ratio, 0.87). Conclusions A gulf exists in the representation of different PRS specialties among clinical trials. We highlight the role of funding source in trial design and data reporting to identify a potential source of financial waste and to stress the need for continued appropriate oversight.

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The use of study registration and protocols in plastic surgery research: A systematic review

Abstract: Publication or registration of protocols for recent studies involving human participants in major plastic surgery journals is low. There is considerable scope to improve this and guidance is provided.

Cited by 9 publications

References 18 publications

Assessing the compliance of systematic review articles published in leading dermatology journals with the PRISMA statement guidelines: A systematic review

Assessing the compliance of systematic review articles published in leading dermatology journals with the PRISMA statement guidelines: A systematic review

InternationalEndodonticJournal policy on mandatory prospective (a priori) protocol registration for clinical trials and systematic reviews

Characterizing Clinical Trials in Plastic and Reconstructive Surgery

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