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Journal of Medical Internet Research Aug 2023Inconsistencies between a protocol and its umbrella review (UR) may mislead readers about the importance of findings or lead to false-positive results. Furthermore, not...
BACKGROUND
Inconsistencies 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.
OBJECTIVE
This study aimed to investigate the inconsistency of protocols with their URs in the methodology and assess the transparency of the URs.
METHODS
We 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.
RESULTS
We 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.
CONCLUSIONS
There 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.
Topics: Humans; Publications; Research Design; Databases, Factual; Review Literature as Topic
PubMed: 37531172
DOI: 10.2196/43299 -
Journal of Stroke and Cerebrovascular... Jan 2016Protocol deviations before and after tissue plasminogen activator (tPA) treatment for ischemic stroke are common. It is unclear if patient or hospital factors predict...
BACKGROUND
Protocol deviations before and after tissue plasminogen activator (tPA) treatment for ischemic stroke are common. It is unclear if patient or hospital factors predict protocol deviations. We examined predictors of protocol deviations and the effects of protocol violations on symptomatic intracerebral hemorrhage (sICH).
METHODS
We used data from the Increasing Stroke Treatment through Interventional Behavior Change Tactics trial, a cluster-randomized, controlled trial evaluating the efficacy of a barrier assessment and educational intervention to increase appropriate tPA use in 24 Michigan community hospitals, to review tPA treatments between 2007 and 2010. Protocol violations were defined as deviations from the standard tPA protocol, both before and after treatment. Multilevel logistic regression models were fitted to determine if patient and hospital variables were associated with pretreatment or post-treatment protocol deviations.
RESULTS
During the study, 557 patients (mean age 70, 52% male, median National Institutes of Health Stroke Scale score 12) were treated with tPA. Protocol deviations occurred in 233 (42%) patients: 16% had pretreatment deviations, 35% had post-treatment deviations, and 9% had both. The most common protocol deviations included elevated post-treatment blood pressure, antithrombotic agent use within 24 hours of treatment, and elevated pretreatment blood pressure. Protocol deviations were not associated with sICH, stroke severity, or hospital factors. Older age was associated with pretreatment protocol deviations (adjusted odds ratio [OR], .52; 95% confidence interval [CI], .30-.92). Pretreatment deviations were associated with post-treatment deviations (adjusted OR, 3.20; 95% CI, 1.91-5.35).
CONCLUSIONS
Protocol deviations were not associated with sICH. Aside from age, patient and hospital factors were not associated with protocol deviations.
Topics: Age Factors; Brain Ischemia; Cerebral Hemorrhage; Clinical Protocols; Emergency Service, Hospital; Fibrinolytic Agents; Guideline Adherence; Health Personnel; Hospitals, Community; Humans; Hypertension; Infusions, Intravenous; Logistic Models; Multicenter Studies as Topic; Randomized Controlled Trials as Topic; Recombinant Proteins; Thrombolytic Therapy; Tissue Plasminogen Activator; Treatment Outcome
PubMed: 26419527
DOI: 10.1016/j.jstrokecerebrovasdis.2015.08.036 -
The Journal of Prosthetic Dentistry Sep 2015Even though high-precision technologies have been used in computer-guided implant surgery, studies have shown that linear and angular deviations between the planned and...
STATEMENT OF PROBLEM
Even though high-precision technologies have been used in computer-guided implant surgery, studies have shown that linear and angular deviations between the planned and placed implants can be expected.
PURPOSE
The purpose of this study was to evaluate the effect of operator experience on the accuracy of implant placement with a computer-guided surgery protocol.
MATERIAL AND METHODS
Ten surgically experienced and 10 surgically inexperienced operators participated in this study. Each operator placed 1 dental implant (Replace Select) on the partially edentulous mandibular model that had been planned with software by following a computer-guided surgery (NobelGuide) protocol. Three-dimensional information of the planned and placed implants were then superimposed. The horizontal and vertical linear deviations at both the apex and platform levels and the angular deviation were measured and compared between the experienced and inexperienced groups with the independent t test with Bonferroni adjustment (α=.01). The magnitude and direction of the horizontal deviations were also measured and recorded.
RESULTS
No significant differences were found in the angular and linear deviations between the 2 groups (P>.01). Although not statistically significant (P>.01), the amount of vertical deviation in the coronal direction of the implants placed by the inexperienced operators was about twice that placed by the experienced operators. Overall, buccal apical deviations were most frequent and of the highest magnitude.
CONCLUSIONS
When a computer-guided protocol was used, the accuracy of the vertical dimension (depth of implant placement) was most influenced by the operator's level of experience.
Topics: Computer-Aided Design; Cone-Beam Computed Tomography; Dental Implantation; Dental Implants; Humans; Image Processing, Computer-Assisted; Jaw, Edentulous, Partially; Mandible; Mouth, Edentulous; Software; Surgery, Computer-Assisted; User-Computer Interface
PubMed: 26119019
DOI: 10.1016/j.prosdent.2015.04.004 -
ACS Omega Dec 2020The KID (Koopmans in DFT) protocol usually applies in organic molecules of the closed-shell type. We used the KID procedure on an open-shell Mo-based system for the...
The KID (Koopmans in DFT) protocol usually applies in organic molecules of the closed-shell type. We used the KID procedure on an open-shell Mo-based system for the first time to choose the most suitable density functional to compute global and local reactivity descriptors obtained from the conceptual density-functional theory (DFT). From a set of 18 density functionals, spread from the second until the fourth rung of Jacob's ladder: BLYP, BP86, B97-D, MN12-L, MN15-L, M06-L, M11-L, CAM-B3LYP, PBE0, B3LYP, N12-SX, M06-2X, MN15, MN12-SX, ωB97X-D, M11, LC-ωHPBE, and APFD, we concluded that CAM-B3LYP provides the best outcome, and in the second place, M06-2X. Because the vertical first ionization potential and vertical first electron affinity in the ground state (gs) are defined as follows = ( - 1) - () and = () - ( + 1), where ( - 1), (), and ( + 1) correspond to energies of the system bearing , + 1, and - 1 electrons, along with Koopmans' theorem (KT) given by ≈ -ε (ε, highest occupied molecular orbital energy) and ≈ -ε (ε, lowest unoccupied molecular orbital energy), the deviation from the KT was performed by the use of the index, such that = | ( - 1) - () + ε| and = | () - ( + 1) + ε|, which are absolute deviations from the perspective of and , respectively. Furthermore, the ε (SOMO: singly-occupied molecular orbital energy) leads us to another index given by |ΔSL| = |ε - ε|. Therefore, and |ΔSL| are indexes defined to evaluate the quality of the KT when employed within the context of quantum chemical calculations based on DFT and not the Hartree-Fock theory. We propose the index that could be more suitable to choose the most proper density functional because the and |ΔSL| are independent indexes.
PubMed: 33283103
DOI: 10.1021/acsomega.0c04450 -
Journal of Clinical Medicine Apr 2022Guided implant surgery can enhance implant placement positioning, increasing predictability and decreasing postoperative complications., To date, the best protocol to be...
Guided implant surgery can enhance implant placement positioning, increasing predictability and decreasing postoperative complications., To date, the best protocol to be used for template realization is still unknown. Thus, the aim herein was to clinically compare the accuracy of two different protocols. A total of 48 implants were divided into Group A (24 implants), in which a stereolithographic template was realized using the digital imaging and communications in medicine (DICOM) data arrived from cone beam computer tomographies (CBCTs) (patients and prothesis alone), and Group B (24 implant), in which a standard intraoral stent with a standardized extraoral support was used for patients’ intraoral impressions and CBCT. The preimplant virtual planning and postsurgery CBCT images of both groups were superimposed, and differences were registered in terms of average deviations at the platform (a) and implant apex (b), mean depth change (c), and angular deviation (d). The results demonstrated that there were no statistically significant differences between groups (p = 0.76) for the parameters measured. However, statistically significant differences (p < 0.05) were found between maxillary and mandible implant surgery, as the latter showed greater accuracy. Additional studies are necessary to further reduce discrepancies between planning and surgical procedures.
PubMed: 35566462
DOI: 10.3390/jcm11092336 -
Access Microbiology 2023Diagnosis of COVID-19 (coronavirus disease 2019) is best performed with real-time (quantitative) PCR (qPCR), the most sensitive method for detection and quantification...
INTRODUCTION
Diagnosis of COVID-19 (coronavirus disease 2019) is best performed with real-time (quantitative) PCR (qPCR), the most sensitive method for detection and quantification of viral RNA. Using the Centers for Disease Control and Prevention (CDC) protocol, for each sample tested for the virus, three qPCR tests are performed, targeting the viral genes N1 and N2, in addition to the internal control gene RNase P. Samples in which internal control fails to amplify should be labelled 'invalid'.
METHODS
This study aims to determine the frequency of inhibition of the RNase P gene used as an internal control in qPCR tests for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) in a reference hospital in Southern Brazil during the COVID-19 pandemic (1 February 2021 to 31 March 2021).
RESULTS
A total 10, 311 samples were available for analysis. The mean cycle threshold (Ct) value for the RNAse P gene was 26.65 and the standard deviation was 3.18. A total of 252 samples were inhibited (2.4%) during the study period: amongst these, 77 (30.5%) showed late amplifications (beyond 2 standard deviations from the mean Ct value), and 175 (69.4%) revealed no fluorescence at all for the RNase P gene.
CONCLUSIONS
This study showed a low percentage of inhibition using RNase P as an internal control in COVID-19 PCRs using the CDC protocol, thus proving the effectiveness of this protocol for identification of SARS-CoV-2 in clinical samples. Re-extraction was efficacious for samples that showed little or no fluorescence for the RNase P gene.
PubMed: 37323943
DOI: 10.1099/acmi.0.000478.v3 -
Journal of Clinical Medicine Apr 2022To compile existing knowledge on the level of cervical regeneration (detected by ultrasound) after loop electrosurgical excision procedure (LEEP) and to suggest research... (Review)
Review
OBJECTIVE
To compile existing knowledge on the level of cervical regeneration (detected by ultrasound) after loop electrosurgical excision procedure (LEEP) and to suggest research protocol for further studies.
METHODS
We conducted a literature search of Medline, Web of Science, Scopus, and Cochrane databases using the keywords "cervix" and "regeneration" without year restrictions. Our eligibility criteria included studies that analysed cervical volume and length regeneration using ultrasound. A literature review was conducted following PRISMA guidelines and registered in PROSPERO (reg. no. CRD42021264062). Information about the studies was extracted from each analysed study on an Excel datasheet and the average regeneration with standard deviation was calculated. All included studies' possible biases were assessed by the National Institutes of Health's (NIH) quality assessment tool.
RESULTS
The literature search identified 802 papers and four trials ( = 309) that met our criteria. They investigated cervical length and volume regeneration after LEEP using ultrasound, concluding that there is a profound regeneration deficit. Average cervical length regeneration after 6 months was 83.4% (±10.8%) and volume regeneration was 87.4% (±6.1%). All analysed studies had their biases; therefore, based on the conducted studies' protocols, we present a CeVaLEP research protocol to guide high-quality studies.
CONCLUSION
After LEEP, there is a cervical regeneration deficit. There is a lack of high-quality studies that assess cervical volume regeneration and its relation to obstetrical outcomes. There is a gap in the field and more research is needed to define the prenatal risks related to cervical regeneration.
PubMed: 35456188
DOI: 10.3390/jcm11082096 -
JMIR Research Protocols Oct 2020Approximately 90% of currently published clinical and public health research is in the form of observational studies. Having a detailed and registered study protocol...
BACKGROUND
Approximately 90% of currently published clinical and public health research is in the form of observational studies. Having a detailed and registered study protocol prior to data collection is important in any empirical study. Without this, there is no reliable way to assess the occurrence of publication bias, outcome reporting bias, and other protocol deviations. However, there is currently no solid guidance available on the information that a protocol for an observational study should contain.
OBJECTIVE
The aim of this study is to formulate the Standardized Protocol Items Recommendations for Observational Studies (SPIROS) reporting guidelines, which focus on 3 main study designs of analytical epidemiology: cohort, case-control, and cross-sectional studies.
METHODS
A scoping review of published protocol papers of observational studies in epidemiology will identify candidate items for the SPIROS reporting guidelines. The list of items will be extended with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist items and recommendations from the SPIROS steering committee. This long list serves as the basis for a 2-round Delphi survey among experts to obtain consensus on which items to include. Each candidate item from the long list will be rated on a 5-point Likert scale to assess relevance for inclusion in the SPIROS reporting guidelines. Following the Delphi survey, an expert-driven consensus workshop will be convened to finalize the reporting guidelines.
RESULTS
A scoping review of published observational study protocols has been completed, with 59 candidate items identified for inclusion into the Delphi survey, itself launched in early 2020.
CONCLUSIONS
This project aims to improve the timeliness, completeness, and clarity of study protocols of observational studies in analytical epidemiology by producing expert-based recommendations of items to be addressed. These reporting guidelines will facilitate and encourage researchers to prepare and register study protocols of sufficient quality prior to data collection in order to improve the transparency, reproducibility, and quality of observational studies.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
PRR1-10.2196/17864.
PubMed: 33084592
DOI: 10.2196/17864 -
Journal of Clinical Medicine May 2019Breast density, a measure of dense fibroglandular tissue relative to non-dense fatty tissue, is confirmed as an independent risk factor of breast cancer. Although there... (Review)
Review
Breast density, a measure of dense fibroglandular tissue relative to non-dense fatty tissue, is confirmed as an independent risk factor of breast cancer. Although there has been an increasing interest in the quantitative assessment of breast density, no research has investigated the optimal technical approach of breast MRI in this aspect. Therefore, we performed a systematic review and meta-analysis to analyze the current studies on quantitative assessment of breast density using MRI and to determine the most appropriate technical/operational protocol. Databases (PubMed, EMBASE, ScienceDirect, and Web of Science) were searched systematically for eligible studies. Single arm meta-analysis was conducted to determine quantitative values of MRI in breast density assessments. Combined means with their 95% confidence interval (CI) were calculated using a fixed-effect model. In addition, subgroup meta-analyses were performed with stratification by breast density segmentation/measurement method. Furthermore, alternative groupings based on statistical similarities were identified via a cluster analysis employing study means and standard deviations in a Nearest Neighbor/Single Linkage. A total of 38 studies matched the inclusion criteria for this systematic review. Twenty-one of these studies were judged to be eligible for meta-analysis. The results indicated, generally, high levels of heterogeneity between study means within groups and high levels of heterogeneity between study variances within groups. The studies in two main clusters identified by the cluster analysis were also subjected to meta-analyses. The review confirmed high levels of heterogeneity within the breast density studies, considered to be due mainly to the applications of MR breast-imaging protocols and the use of breast density segmentation/measurement methods. Further research should be performed to determine the most appropriate protocol and method for quantifying breast density using MRI.
PubMed: 31137728
DOI: 10.3390/jcm8050745 -
Journal of the American Heart... May 2022Background In the GLOBAL LEADERS trial, ticagrelor monotherapy beyond 1 month compared with standard antiplatelet regimens after coronary stent implantation did not... (Clinical Trial)
Clinical Trial
Background In the GLOBAL LEADERS trial, ticagrelor monotherapy beyond 1 month compared with standard antiplatelet regimens after coronary stent implantation did not improve outcomes at intention-to-treat analysis. Considerable differences in treatment adherence between the experimental and control groups may have affected the intention-to-treat results. In this reanalysis of the GLOBAL LEADERS trial, we compared the experimental and control treatment strategies in a per-protocol analysis of patients who did not deviate from the study protocol. Methods and Results Baseline and postrandomization information were used to classify whether and when patients were deviating from the study protocol. With logistic regressions, we derived time-varying inverse probabilities of nondeviation from protocol to reconstruct the trial population without protocol deviation. The primary end point was a composite of all-cause mortality or nonfatal Q-wave myocardial infarction at 2 years. At 2-year follow-up, 1103 (13.8%) of 7980 patients in the experimental group and 785 (9.8%) of 7988 patients in the control group qualified as protocol deviators. At per-protocol analysis, the rate ratio for the primary end point was 0.88 (95% CI, 0.75-1.03; =0.10) on the basis of 274 versus 325 events in the experimental versus control group. The rate ratio for the key safety end point of major bleeding was 1.00 (95% CI, 0.79-1.26; =0.99). The per-protocol and intention-to-treat effect estimates were overall consistent. Conclusions Among patients who complied with the study protocol in the GLOBAL LEADERS trial, ticagrelor plus aspirin for 1 month followed by ticagrelor monotherapy was not superior to 1-year standard dual antiplatelet therapy followed by aspirin alone at 2 years after coronary stenting. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01813435.
Topics: Aspirin; Drug Therapy, Combination; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Ticagrelor; Treatment Outcome
PubMed: 35229616
DOI: 10.1161/JAHA.121.024291