Antimicrobial Desensitization: A Review of Published Protocols.
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ABSTRACT:
SUBMITTER: Chastain DB
PROVIDER: S-EPMC6789802 | biostudies-literature | 2019 Aug
REPOSITORIES: biostudies-literature
Publications
Antimicrobial Desensitization: A Review of Published Protocols.
Chastain Daniel B DB Hutzley Vanessa Johanna VJ Parekh Jay J Alegro Jason Val G JVG
Pharmacy (Basel, Switzerland) 20190809 3
Antimicrobial desensitization represents a last-line option for patients with no alternative therapies, where the benefits of this intensive process must outweigh the potential harm from drug exposure. The goal of antimicrobial desensitization procedures is to establish a temporary state of tolerance to drugs that may otherwise cause hypersensitivity reactions. While no universal antimicrobial desensitization protocols exist, this review critically analyzes previously published desensitization p ...[more]
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Project description:BackgroundInconsistencies between a protocol and its umbrella review (UR) may mislead readers about the importance of findings or lead to false-positive results. Furthermore, not documenting and explaining inconsistencies in the UR could reduce its transparency. To our knowledge, no study has examined the methodological consistency of the protocols with their URs and assessed the transparency of the URs when generating evidence.ObjectiveThis study aimed to investigate the inconsistency of protocols with their URs in the methodology and assess the transparency of the URs.MethodsWe searched medical-related electronic databases from their inception to January 1, 2022. We investigated inconsistencies between protocols and their publications and transparencies in the search strategy, inclusion criteria, methods of screening and data extraction, quality assessment, and statistical analysis.ResultsWe included 31 protocols and 35 publications. For the search strategy, 39 inconsistencies between the protocols and their publications were found in 26 of the 35 (74%) URs, and 16 of these inconsistencies were indicated and explained. There were 84 inconsistencies between the protocols and their URs regarding the inclusion criteria in 31 of the 35 (89%) URs, and 29 of the inconsistencies were indicated and explained. Deviations from their protocols were found in 12 of the 32 (38%) URs reporting the methods of screening, 14 of the 30 (47%) URs reporting the methods of data extraction, and 11 of the 32 (34%) URs reporting the methods for quality assessment. Of the 35 URs, 6 (17%) were inconsistent with their protocols in terms of the tools for quality assessment; one-half (3/6, 50%) of them indicated and explained the deviations. As for the statistical analysis, 31 of the 35 (89%) URs generated 61 inconsistencies between the publications and their protocols, and 16 inconsistencies were indicated and explained.ConclusionsThere was a high prevalence of inconsistencies between protocols and publications of URs, and more than one-half of the inconsistencies were not indicated and explained in the publications. Therefore, how to promote the transparency of URs will be a major part of future work.
| S-EPMC10433027 | biostudies-literature
Project description:ObjectivesTo map published data of antimicrobial stewardship (AMS) interventions that are currently being carried out in hospitals and clinics in the public and private health sectors of South Africa in line with the antimicrobial resistance (AMR) strategy of South Africa.MethodsA systematic scoping review was conducted to identify AMS initiatives in the public and private health sectors of South Africa for the period 1 January 2000 to 31 March 2019. An electronic search of databases was made including PubMed, Scopus, a key medical journal (South African Medical Journal), University of KwaZulu-Natal (UKZN) WorldCat iCatalogue and AMR networks: Federation of Infectious Diseases Societies in South Africa (FIDSSA). Reference lists of published articles were also reviewed for inclusion. Keywords included 'antimicrobial antibiotic stewardship South Africa'.FindingsOf a total of 411 articles, using a stepwise screening process, 18 articles were selected for inclusion in the review. The interventions/initiatives were divided into four broad categories: (i) AMS intervention: prescription audits and usage; (ii) AMS intervention: education and its impact; (iii) other AMS interventions; and (iv) the role of different healthcare professionals in AMS.ConclusionsThe data identifies a need for and the value of AMS in both the public and private health sectors of South Africa. Initiatives are carried out across both sectors but more attention needs to be focused on AMS implementation in line with the National AMR Strategy of South Africa. Collaboration between the different sectors will aid in overcoming the AMR challenge.
| S-EPMC8210007 | biostudies-literature
Project description:Poor reporting can lead to inadequate presentation of data, confusion regarding research methodology used, selective reporting of results, and other misinformation regarding health research. One of the most recent attempts to improve quality of reporting comes from the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Group, which makes recommendations for the reporting of protocols. In this report, we present a protocol for a systematic review of published surgical randomised controlled trial (RCT) protocols, with the purpose of assessing the reporting quality and completeness of the statistical aspects.We will include all published protocols of randomised trials that investigate surgical interventions. We will search MEDLINE, EMBASE, and CENTRAL for relevant studies. Author pairs will independently review all titles, abstracts, and full texts identified by the literature search, and extract data using a structured data extraction form. We will extract the following: year of publication, country, sample size, description of study population, description of intervention and control, primary outcome, important methodological qualities, and quality of reporting of planned statistical methods based on the SPIRIT guidelines.The results of this review will demonstrate the quality of statistical reporting of published surgical RCT protocols. This knowledge will inform recommendations to surgeons, researchers, journal editors and peer reviewers, and other knowledge users that focus on common deficiencies in reporting and how to rectify them. Ethics approval for this study is not required. We will disseminate the results of this review in peer-reviewed publications and conference presentations, and at a doctoral independent study of oral defence.
| S-EPMC4893854 | biostudies-other
Project description:BackgroundAn estimand is a precise description of the treatment effect to be estimated from a trial (the question) and is distinct from the methods of statistical analysis (how the question is to be answered). The potential use of estimands to improve trial research and reporting has been underpinned by the recent publication of the ICH E9(R1) Addendum on the use of estimands in clinical trials in 2019. We set out to assess how well estimands are described in published trial protocols.MethodsWe reviewed 50 trial protocols published in October 2020 in Trials and BMJ Open. For each protocol, we determined whether the estimand for the primary outcome was explicitly stated, not stated but inferable (i.e. could be constructed from the information given), or not inferable.ResultsNone of the 50 trials explicitly described the estimand for the primary outcome, and in 74% of trials, it was impossible to infer the estimand from the information included in the protocol. The population attribute of the estimand could not be inferred in 36% of trials, the treatment condition attribute in 20%, the population-level summary measure in 34%, and the handling of intercurrent events in 60% (the strategy for handling non-adherence was not inferable in 32% of protocols, and the strategy for handling mortality was not inferable in 80% of the protocols for which it was applicable). Conversely, the outcome attribute was stated for all trials. In 28% of trials, three or more of the five estimand attributes could not be inferred.ConclusionsThe description of estimands in published trial protocols is poor, and in most trials, it is impossible to understand exactly what treatment effect is being estimated. Given the utility of estimands to improve clinical research and reporting, this urgently needs to change.
| S-EPMC8500821 | biostudies-literature
Project description:Background: As desensitization protocols become more readily available and published, more institutions are implementing them and searching for ways to streamline the process. There have been no published studies to date on the effect that electronic medical record systems (EMR) have on the safety and efficiency of β-lactam antibiotic desensitization. Objective: The purpose of this study was to evaluate the changes in workflow, efficiency, and medical errors after implementation of β-lactam antibiotic desensitization. Methods: A collaborative effort between the Allergy/Immunology Division and the Pharmacy Department led to the creation and implementation of antibiotic desensitization order sets. Pre- and postimplementation of β-lactam antibiotic surveys were sent to pharmacists and allergy/immunology fellows and attendings at a single-center tertiary care center. Results: There were only 26 valid respondents (12.3%) to both the pre- and postimplementation surveys. The percentage of respondents who thought that the time needed to prepare desensitization materials was < 4 hours increased from 23% to 77% (p < 0.001). The percentage of respondents who thought that the time needed to input electronic desensitization orders was < 1 hour increased from 19% to 54% (p = 0.002). The percentage of respondents who identified zero errors increased from 42% to 92% (p = 0.001). The perception of the overall desensitization process efficiency significantly increased (p < 0.001). Conclusion: Creation of standardized electronic β-lactam antibiotic desensitization order sets significantly decreased the time taken to order and prepare materials and increased overall efficiency.
| S-EPMC8133017 | biostudies-literature
Project description:Antimicrobial resistance (AMR) has become a global threat to not only public health impacts but also clinical and economic outcomes. During the past decades, there have been many studies focusing on surveillance, mechanisms, and diagnostics of AMR in infectious diseases but the impacts on public health, clinical and economic outcomes due to emergence of these AMRs are rarely studied and reported. This review was aimed to summarize the findings from published studies to report the outcome impacts due to AMR of malaria, tuberculosis and HIV and briefly discuss the implications for application to other infectious diseases. PubMed/Medline and Google Scholar databases were used for search of empirical and peer-reviewed papers reporting public health, clinical and economic outcomes due to AMR of malaria, tuberculosis and HIV. Papers published through 1 December 2019 were included in this review. A total of 76 studies were included for this review, including 16, 49 and 11 on public health, clinical and economic outcomes, respectively. The synthesized data indicated that the emergence and spread of AMR of malaria, tuberculosis and HIV have resulted in adverse public health, clinical and economic outcomes. AMR of malaria, tuberculosis and HIV results in significant adverse impacts on public health, clinical and economic outcomes. Evidence from this review suggests the needs to consider the similar studies for other infectious diseases.
| S-EPMC7068360 | biostudies-literature
Project description:ImportancePublishing study protocols might reduce research waste because of unclear methods or incomplete reporting; on the other hand, there might be few additional benefits of publishing protocols for registered trials that are never completed or published. No study has investigated the proportion of published protocols associated with published results.ObjectiveTo estimate the proportion of published trial protocols for which there are not associated published results.Design, setting, and participantsThis cross-sectional study used stratified random sampling to identify registered clinical trials with protocols published between January 2011 and August 2022 and indexed in PubMed Central. Ongoing studies and those within 1 year of the primary completion date on ClinicalTrials.gov were excluded. Published results were sought from August 2022 to March 2023 by searching ClinicalTrials.gov, emailing authors, and using an automated tool, as well as through incidental discovery.Main outcomes and measuresThe primary outcome was a weighted estimate of the proportion of registered trials with published protocols that also had published main results. The proportion of trials with unpublished results was estimated using a weighted mean.ResultsFrom 1500 citations that were screened, 308 clinical trial protocols were included, and it was found that 87 trials had not published their main results. Most included trials were investigator-initiated evaluations of nonregulated products. When published, results appeared a mean (SD) of 3.4 (2.0) years after protocol publications. With the use of a weighted mean, an estimated 4754 (95% CI, 4296-5226) eligible clinical trial protocols were published and indexed in PubMed Central between 2011 and 2022. In the weighted analysis, 1708 of those protocols (36%; 95% CI, 31%-41%) were not associated with publication of main results. In a sensitivity analysis excluding protocols published after 2019, an estimated 25% (95% CI, 20%-30%) of 3670 (95% CI, 3310-4032) protocol publications were not associated with publication of main results.Conclusions and relevanceThis cross-sectional study of clinical trial protocols published on PubMed Central between 2011 and 2022 suggests that many protocols were not associated with subsequent publication of results. The overall benefits of publishing study protocols might outweigh the research waste caused by unnecessary protocol publications.
| S-EPMC10774993 | biostudies-literature
Project description:ContextElbow medial ulnar collateral ligament (UCL) injuries have become increasingly common in athletes. Despite this, rehabilitation protocols appear to vary drastically, which may explain the clinical equipoise regarding optimal management.ObjectiveThis systematic review reports rehabilitation characteristics reported after UCL injuries and compares reported outcomes based on early versus delayed rehabilitation.Data sourcesOur search utilized PubMed/MEDLINE, Embase, Web of Science, and Cochrane to identify all articles on UCL rehabilitation published between January 1, 2002 and October 1, 2022.Study selectionStudies in English with ≥5 patients that reported rehabilitation protocols for UCL injuries were evaluated.Study designSystematic review.Level of evidenceLevel 4.Data extractionData included sample characteristics, time to achieve physical therapy milestones, outcome scores, and return-to-play (RTP) rate and timing.ResultsOur review included 105 articles with a total of 15,928 elbows (98% male; weighted mean age, 23 years; follow-up, 47 months), with 15,077 treated operatively and 851 treated nonoperatively. The weighted mean time patients spent adhering to nonweightbearing status was 42 days. The mean time until patients were given clearance for active range of motion (ROM) 15 days, full ROM 40 days, and elbow strengthening exercises 32 days. The mean time until all restrictions were lifted was 309 days. The mean time to begin a throwing program was 120 days. Across all rehabilitation characteristics, protocols for patients undergoing nonoperative management started patients on rehabilitation earlier. After UCL reconstruction, earlier active ROM (≤14 days), elbow strengthening (≤30 days), no restrictions (≤180 days), and throwing (≤120 days) postoperatively led to earlier RTP without a negative effect on functional outcome scores.ConclusionCurrent literature provides a spectrum of protocols for elbow UCL rehabilitation, regardless of management. Nonoperative patients began ROM activities, strengthening, and throwing programs sooner than operative patients, and earlier milestones led to earlier RTP.
| S-EPMC11569531 | biostudies-literature
Project description:BackgroundAn a priori design is essential to reduce the risk of bias in systematic reviews (SRs). To this end, authors can register their SR with PROSPERO, and/or publish a SR protocol in an academic journal. The latter has the advantage that the manuscript for the SR protocol is usually peer-reviewed. However, since authors ought not to begin/continue the SR before their protocol has been accepted for publication, it is crucial that SR protocols are processed in a timely manner. Our main aim was to descriptively analyse the peer review process of SR protocols published in 'BMC Systematic Reviews' from 2012 to 2017.MethodsWe systematically searched MEDLINE via PubMed for all SR protocols published in 'BMC Systematic Reviews' between 2012 and 2017, except for protocols for overviews, scoping reviews or realist reviews. Data were extracted from the SR protocols and Open Peer Review reports. For each round of peer review, two researchers judged the extent of revision (minor/major) based on the reviewer reports. Their content was further investigated by two researchers in a random 10%-sample using PRISMA-P as a guideline. All data were analysed descriptively.ResultsWe identified 544 eligible protocols published in 'BMC Systematic Reviews' between 2012 and 2017. Of those, 485 (89.2%) also registered the SR in PROSPERO, the majority (87.4%) before first submission of the manuscript for the SR protocol (median 49 days). The absolute number of published SR protocols increased from 2012 to 2017 (21 vs 145 protocols), as did the median processing time (61 vs 142 days from submission to acceptance) and the proportion of protocols requiring a major revision after first peer review (19.1% vs 52.4%). Reviewer comments most frequently addressed the PRISMA-P item 'Eligibility criteria'. Overall, 76.0% of the reviewer comments suggested more transparency.ConclusionsThe number of published SR protocols increased over the years, but so did the processing time. In 2017, it took several months from submission to acceptance, which is critical from an author's perspective. New models of peer review such as post publication peer review for SR protocols should be investigated. This could probably be realized with PROSPERO.
| S-EPMC6415341 | biostudies-literature
Project description:IntroductionPublishing protocols of randomized controlled trials (RCT) facilitates a more detailed description of study rational, design, and related ethical and safety issues, which should promote transparency. Little is known about how the practice of publishing protocols developed over time. Therefore, this study describes the worldwide trends in volume and methodological quality of published RCT protocols.MethodsA systematic search was performed in PubMed and EMBASE, identifying RCT protocols published over a decade from 1 September 2001. Data were extracted on quality characteristics of RCT protocols. The primary outcome, methodological quality, was assessed by individual methodological characteristics (adequate generation of allocation, concealment of allocation and intention-to-treat analysis). A comparison was made by publication period (First, September 2001- December 2004; Second, January 2005-May 2008; Third, June 2008-September 2011), geographical region and medical specialty.ResultsThe number of published RCT protocols increased from 69 in the first, to 390 in the third period (p<0.0001). Internal medicine and paediatrics were the most common specialty topics. Whereas most published RCT protocols in the first period originated from North America (n = 30, 44%), in the second and third period this was Europe (respectively, n = 65, 47% and n = 190, 48%, p = 0.02). Quality of RCT protocols was higher in Europe and Australasia, compared to North America (OR = 0.63, CI = 0.40-0.99, p = 0.04). Adequate generation of allocation improved with time (44%, 58%, 67%, p = 0.001), as did concealment of allocation (38%, 53%, 55%, p = 0.03). Surgical protocols had the highest quality among the three specialty topics used in this study (OR = 1.94, CI = 1.09-3.45, p = 0.02).ConclusionPublishing RCT protocols has become popular, with a five-fold increase in the past decade. The quality of published RCT protocols also improved, although variation between geographical regions and across medical specialties was seen. This emphasizes the importance of international standards of comprehensive training in RCT methodology.
| S-EPMC5351864 | biostudies-literature