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Trials Dec 2023Retention to trials is important to ensure the results of the trial are valid and reliable. The SPIRIT guidelines (18b) require "plans to promote participant retention... (Review)
Review
BACKGROUND
Retention to trials is important to ensure the results of the trial are valid and reliable. The SPIRIT guidelines (18b) require "plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols" be included in trial protocols. It is unknown how often protocols report this retention information. The purpose of our scoping review is to establish if, and how, trial teams report plans for retention during the design stage of the trial.
MATERIALS AND METHODS
A scoping review with searches in key databases (PubMed, Scopus, EMBASE, CINAHL (EBSCO), and Web of Science from 2014 to 2019 inclusive) to identify randomised controlled trial protocols. We produced descriptive statistics on the characteristics of the trial protocols and also on those adhering to SPIRIT item 18b. A narrative synthesis of the retention strategies was also conducted.
RESULTS
Eight-hundred and twenty-four protocols met our inclusion criteria. RCTs (n = 722) and pilot and feasibility trial protocols (n = 102) reported using the SPIRIT guidelines during protocol development 35% and 34.3% of the time respectively. Of these protocols, only 9.5% and 11.4% respectively reported all aspects of SPIRIT item 18b "plans to promote participant retention and to complete follow-up, including list of any outcome data for participants who discontinue or deviate from intervention protocols". Of the RCT protocols, 36.8% included proactive "plans to promote participant retention" regardless of whether they reported using SPIRIT guidelines or not. Most protocols planned "combined strategies" (48.1%). Of these, the joint most commonly reported were "reminders and data collection location and method" and "reminders and monetary incentives". The most popular individual retention strategy was "reminders" (14.7%) followed by "monetary incentives- conditional" (10.2%). Of the pilot and feasibility protocols, 40.2% included proactive "plans to promote participant retention" with the use of "combined strategies" being most frequent (46.3%). The use of "monetary incentives - conditional" (22%) was the most popular individual reported retention strategy.
CONCLUSION
There is a lack of reporting of plans to promote participant retention in trial protocols. Proactive planning of retention strategies during the trial design stage is preferable to the reactive implementation of retention strategies. Prospective retention planning and clear communication in protocols may inform more suitable choice, costing and implementation of retention strategies and improve transparency in trial conduct.
Topics: Humans; Randomized Controlled Trials as Topic; Retention in Care; Research Design
PubMed: 38049833
DOI: 10.1186/s13063-023-07775-2 -
Open Heart Dec 2023Targeted temperature management (TTM) is a recommended therapy for postcardiac arrest patients. Hyperthermia worsened the patient outcome, and overcooling increased the... (Observational Study)
Observational Study
BACKGROUND
Targeted temperature management (TTM) is a recommended therapy for postcardiac arrest patients. Hyperthermia worsened the patient outcome, and overcooling increased the incidence of complications; therefore, a high-quality TTM is required. The target temperature tended to be modified worldwide after the TTM trial in 2013. Our institute modified the target temperature to 35°C in 2017. This study aimed to compare the conventional and modified protocols, assess the relationship between target temperature deviation and patient outcomes, and identify the factors influencing temperature deviation.
METHODS
This single-centre, retrospective, observational study included adult out-of-hospital cardiac arrest patients who underwent TTM between April 2013 and October 2019. We compared the conventional and modified protocol groups to evaluate the difference in the background characteristics and details on TTM. Subsequently, we assessed the relationship of deviation (>±0.5°C, >37°C, or<33°C) rates from the target temperature with mortality and neurological outcomes. We assessed the factors that influenced the deviation from the target temperature.
RESULTS
Temperature deviation was frequently observed in the conventional protocol group (p=0.012), and the modified protocol group required higher doses of neuromuscular blocking agents (NMBAs) during TTM (p=0.016). Other background data, completion of protocol, incidence of complications, mortality and rate of favourable neurological outcomes were not significantly different. The performance rate of TTM was significantly higher in the modified group than in the conventional protocol group (p<0.001). Temperature deviation did not have an impact on the outcomes. Age, sex, body surface area, NMBA doses and type of cooling device were the factors influencing temperature deviation.
CONCLUSIONS
A target temperature of 35°C might be acceptable and easily attainable if shivering of the patients was well controlled using NMBAs. Temperature deviation did not have an impact on outcomes. The identified factors influencing deviation from target temperature might be useful for ensuring a high-quality TTM.
Topics: Adult; Humans; Body Temperature; Hypothermia, Induced; Retrospective Studies; Temperature; Treatment Outcome; Male; Female
PubMed: 38101858
DOI: 10.1136/openhrt-2023-002459 -
Mutation Research. Genetic Toxicology... Jan 2023Several trials have attempted to identify sources of inter-laboratory variability in comet assay results, aiming at achieving more equal responses. Ionising radiation...
Several trials have attempted to identify sources of inter-laboratory variability in comet assay results, aiming at achieving more equal responses. Ionising radiation induces a defined level of DNA single-strand breaks (per dose/base pairs) and is used as a reference when comparing comet results but relies on accurately determined radiation doses. In this ring test we studied the significance of dose calibrations and comet assay protocol differences, with the object of identifying causes of variability and how to deal with them. Eight participating laboratories, using either x-ray or gamma radiation units, measured dose rates using alanine pellet dosimeters that were subsequently sent to a specialised laboratory for analysis. We found substantial deviations between calibrated and nominal (uncalibrated) dose rates, with up to 46% difference comparing highest and lowest values. Three additional dosimetry systems were employed in some laboratories: thermoluminescence detectors and two aqueous chemical dosimeters. Fricke's and Benzoic Acid dosimetry solutions gave reliable quantitative dose estimations using local equipment. Mononuclear cells from fresh human blood or mammalian cell lines were irradiated locally with calibrated (alanine) radiation doses and analysed for DNA damage using a standardised comet assay protocol and a lab-specific protocol. The dose response of eight laboratories, calculated against calibrated radiation doses, was linear with slope variance CV= 29% with the lab-specific protocol, reduced to CV= 16% with the standard protocol. Variation between laboratories indicate post-irradiation repair differences. Intra-laboratory variation was very low judging from the dose response of 8 donors (CV=4%). Electrophoresis conditions were different in the lab-specific protocols explaining some dose response variations which were reduced by systematic corrections for electrophoresis conditions. The study shows that comet assay data obtained in different laboratories can be compared quantitatively using calibrated radiation doses and that systematic corrections for electrophoresis conditions are useful.
Topics: Animals; Humans; Comet Assay; Calibration; DNA Damage; Radiation, Ionizing; Gamma Rays; Dose-Response Relationship, Radiation; Mammals
PubMed: 36669811
DOI: 10.1016/j.mrgentox.2022.503560 -
Journal of Oral and Maxillofacial... May 2023Implant surgical guides, in combination with implant planning software, have been designed for accurate surgery, especially in partial edentulism. The purpose of this...
PURPOSE
Implant surgical guides, in combination with implant planning software, have been designed for accurate surgery, especially in partial edentulism. The purpose of this study was to examine the effect of fixation pins of surgical guides on the accuracy of static computer-assisted implant surgeries in a maxillary free-end situation.
MATERIALS AND METHODS
This in vitro study was conducted to compare surgical guides using various fixation pin protocols in implant surgery. A patient dental model with missing teeth from maxillary right first premolar to third molar was used as the study model… Implant placement was planned at maxillary right first premolar, right first molar, and right second molar; Straumann full guide templates were designed and fabricated using the coDiagnostiX software. The experiment involved surgical guides with no fixation pins (NF), buccal unilateral fixation pin (BF), palatal unilateral fixation pin (PF), and bilateral fixation pins on the buccal and palatal sides (BPF), based on the position and number of fixation pins. The deviation between the actual and planned positions was used to evaluate implant accuracy. The fixation pin protocols were the primary predictive variables. Angular, 3D platform, and 3D apex deviations were the primary outcome variables. Statistical analysis was performed using the one-way analysis of variance and Tukey's test (α = 0.05).
RESULTS
NF generated the maximum angular deviation (3.65 ± 1.39°), 3D platform deviation (1.58 ± 0.55 mm), and 3D apex deviation (2.18 ± 0.79 mm), whereas BPF produced the minimum angular deviation (1.88 ± 0.86°), 3D platform deviation (1.09 ± 0.51 mm), and 3D apex deviation (1.53 ± 0.45 mm). A statistically significant difference between NF and BPF in the angular deviation, 3D platform, and apex deviation (P < .0001, P = .009, and P = .002, respectively) was identified. The unilateral fixation pin exerted a significant effect only on the angular accuracy (BF, P = .0018; PF, P = .0001).
CONCLUSION
In a maxillary free-end situation, templates with a fixation pin generate better implant accuracy than those without it. A bilateral fixation pin protocol may produce less deviation than those without fixation pins. The implant accuracy does not appear to be affected by the position of the unilateral fixation pin.
Topics: Humans; Dental Implantation, Endosseous; Dental Implants; Cone-Beam Computed Tomography; Imaging, Three-Dimensional; Computer-Aided Design; Surgery, Computer-Assisted
PubMed: 36716792
DOI: 10.1016/j.joms.2022.12.017 -
American Journal of Surgery Jan 2024Enhanced Recovery After Surgery protocols and minimally invasive surgery have decreased colorectal length of stay. Our institution implemented a Same Day Discharge (SDD)... (Review)
Review
BACKGROUND
Enhanced Recovery After Surgery protocols and minimally invasive surgery have decreased colorectal length of stay. Our institution implemented a Same Day Discharge (SDD) colorectal protocol, and this study evaluates factors associated with unplanned admission.
METHODS
. Retrospective review was performed from February 2019 to January 2022. Admitted SDD candidates were identified, and their course evaluated. Demographics, clinical characteristics, and outcomes were compared between cohorts.
RESULTS
Review identified 152 potential SDD patients, 47 successfully discharged. Of the 105 admitted patients, the most common reasons were operative complexity (47.6 %) and social reasons (23.8 %). No differences were seen in operative times, gender, BMI, anticoagulation, or diabetes. The admission cohort was more likely to undergo low anterior resection or right colectomy and was older in age. Case complexity was the highest factor for affecting discharge.
CONCLUSION
SDD can be feasible after colectomy, but in certain patients may require deviation. The most common factors requiring admission were complexity and social factors.
Topics: Humans; Patient Discharge; Colorectal Surgery; Hospitalization; Retrospective Studies; Colorectal Neoplasms; Length of Stay; Postoperative Complications
PubMed: 38587048
DOI: 10.1016/j.amjsurg.2023.09.037 -
Journal of the American Dental... Nov 2022Dental health care personnel (DHCP) may be at increased risk of exposure to severe acute respiratory syndrome coronavirus 2, the virus that causes COVID-19, as well as...
BACKGROUND
Dental health care personnel (DHCP) may be at increased risk of exposure to severe acute respiratory syndrome coronavirus 2, the virus that causes COVID-19, as well as other clinically important pathogens. Proper use of personal protective equipment (PPE) reduces occupational exposure to pathogens. The authors performed an assessment of PPE donning and doffing practices among DHCP, using a fluorescent marker as a surrogate for pathogen transmission.
METHODS
Participants donned PPE (that is, disposable gown, gloves, face mask, and eye protection) and the fluorescent marker was applied to their palms and abdomen. DHCP then doffed PPE according to their usual practices. The donning and doffing processes were video recorded, areas of fluorescence were noted, and protocol deviations were assessed. Statistical analyses included frequency, type, and descriptions of protocol deviations and factors associated with fluorescence.
RESULTS
Seventy DHCP were enrolled. The donning and doffing steps with the highest frequency of protocol deviations were hand hygiene (66% of donning and 78% of doffing observations involved a deviation) and disposable gown use (63% of donning and 60% of doffing observations involved a deviation). Fluorescence was detected on 69% of DHCP after doffing, most frequently on hands. An increasing number of protocol deviations was significantly associated with increased risk of fluorescence. DHCP with a gown doffing deviation, excluding doffing out of order, were more likely to have fluorescence detected.
CONCLUSIONS
DHCP self-contamination was common with both donning and doffing PPE.
PRACTICAL IMPLICATIONS
Proper use of PPE is an important component of occupational health.
Topics: Humans; Personal Protective Equipment; COVID-19; Health Personnel; SARS-CoV-2; Delivery of Health Care
PubMed: 36175202
DOI: 10.1016/j.adaj.2022.08.004 -
Journal of Dentistry Aug 2023To (1) validate the use of a post-operative intraoral scan (IOS) versus Cone Beam Computed Tomography (CBCT), gold standard, on its ability to measure the accuracy of...
OBJECTIVES
To (1) validate the use of a post-operative intraoral scan (IOS) versus Cone Beam Computed Tomography (CBCT), gold standard, on its ability to measure the accuracy of guided endodontics, and (2) present clinical data on the accuracy of guided endodontics.
METHODS
Four models, including 10 extracted teeth each, were created. Forty guided access cavities were planned on dentin to simulate pulp canal obliteration (PCO). Two operators performed guided access cavities. A post-operative CBCT and IOS were acquired. The coronal, apical, and angular deviations were measured with CBCT and IOS. Clinical accuracy was measured using an IOS acquired immediately after drilling the access cavity with the aid of a guide. Data analysis was performed using multiway Anova and corrected for simultaneous hypothesis testing according to Tukey. P ≤ 0.05 was considered statistically significant. Descriptive statistics on the clinical accuracy of guided endodontics were performed.
RESULTS
Thirty-eight cavities were assessed with a mean length of 13.8 mm. No statistical difference between operators and methods was found for all parameters (P > 0.05). Thirty-three patients were treated with guided endodontics and measured using an IOS. Results show an average coronal, apical, and angular deviation of 0.2 mm, 0.45 mm, and 1.91 respectively. The average length of the access cavities was 12.5 mm.
CONCLUSIONS
An IOS can be used to measure the accuracy of guided endodontics. Clinical data showed high accuracy of guided endodontics with a mean apical deviation smaller than 0.5 mm and a mean angular deviation of less than 2.
CLINICAL SIGNIFICANCE
The use of an IOS does not involve additional radiation exposure. A safety margin of at least 1 mm around the planned trajectory should be respected when planning the case to minimize the possibility of root perforation.
Topics: Humans; Dental Pulp Cavity; Endodontics; Dental Caries; Dental Pulp Diseases; Cone-Beam Computed Tomography
PubMed: 37263407
DOI: 10.1016/j.jdent.2023.104566 -
Clinical Oral Implants Research Sep 2021To compare fully guided with conventionally guided implant surgery performed by dental students in terms of deviation of actual implant position from an ideal implant... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To compare fully guided with conventionally guided implant surgery performed by dental students in terms of deviation of actual implant position from an ideal implant position.
MATERIALS AND METHODS
Twenty-five patients in need of 26 straightforward implant-supported single crowns were randomly allocated to a fully guided (FG, n = 14) or a conventionally guided (CG, n = 12) implant surgery. In the preoperative CBCTs, 3 experienced investigators placed a virtual implant in the ideal position, twice, allowing deviational analysis in the facio-lingual (coronal) and mesio-distal (sagittal) planes for 7 parameters. Facio-lingual crestal deviation, facio-lingual apical deviation, facio-lingual angular deviation, mesio-distal crestal deviation, mesio-distal apical deviation, mesio-distal angular deviation, and vertical deviation between the ideal, virtually placed position and actual implant position for the FG and CG groups were compared statistically (p < .05).
RESULTS
Statistically significant differences between ideal and actual implant position were only seen for the facio-lingual apical deviation (p = .047) and for the facio-lingual angular deviation (p = .019), where the CG group deviated more from the ideal position than the FG group. The 5 other examined variables did not show any significant differences, and none of the implants in the FG group and CG group were placed in conflict with the clinical guidelines.
CONCLUSIONS
The present study reported no difference in 5 out of 7 deviational parameters concerning actual implant position in relation to ideal implant position between a FG and CG implant placement protocol performed by dental students. Facio-lingual angular deviation and apical deviation were lower, when a FG protocol was followed. All implants were positioned according to clinical guidelines.
Topics: Computer-Aided Design; Crowns; Dental Implantation, Endosseous; Dental Implants; Humans; Students, Dental; Surgery, Computer-Assisted
PubMed: 34166539
DOI: 10.1111/clr.13802 -
Epidemiology (Cambridge, Mass.) Jul 2021Important questions exist regarding the comparative effectiveness of alternative childhood vaccine schedules; however, optimal approaches to studying this complex issue...
BACKGROUND
Important questions exist regarding the comparative effectiveness of alternative childhood vaccine schedules; however, optimal approaches to studying this complex issue are unclear.
METHODS
We applied methods for studying dynamic treatment regimens to estimate the comparative effectiveness of different rotavirus vaccine (RV) schedules for preventing acute gastroenteritis-related emergency department (ED) visits or hospitalization. We studied the effectiveness of six separate protocols: one- and two-dose monovalent rotavirus vaccine (RV1); one-, two-, and three-dose pentavalent rotavirus vaccine (RV5); and no RV vaccine. We used data on all infants to estimate the counterfactual cumulative risk for each protocol. Infants were censored when vaccine receipt deviated from the protocol. Inverse probability of censoring-weighted estimation addressed potentially informative censoring by protocol deviations. A nonparametric group-based bootstrap procedure provided statistical inference.
RESULTS
The method yielded similar 2-year effectiveness estimates for the full-series protocols; weighted risk difference estimates comparing unvaccinated children to those adherent to either full-series (two-dose RV1, three-dose RV5) corresponded to four fewer hospitalizations and 12 fewer ED visits over the 2-year period per 1,000 children. We observed dose-response relationships, such that additional doses further reduced risk of acute gastroenteritis. Under a theoretical intervention to fully vaccinate all children, the 2-year risk differences comparing full to observed adherence were 0.04% (95% CI = 0.03%, 0.05%) for hospitalizations and 0.17% (95% CI = 0.14%, 0.19%) for ED visits.
CONCLUSIONS
The proposed approach can generate important evidence about the consequences of delaying or skipping vaccine doses, and the impact of interventions to improve vaccine schedule adherence.
Topics: Child; Gastroenteritis; Hospitalization; Humans; Infant; Rotavirus; Rotavirus Infections; Rotavirus Vaccines; Vaccines, Attenuated
PubMed: 33927157
DOI: 10.1097/EDE.0000000000001363 -
Radiotherapy and Oncology : Journal of... May 2022Image-guided adaptive brachytherapy (IGABT) is a key component in the treatment of cervical cancer, but the nature of the clinical workflow makes it vulnerable to...
BACKGROUND AND PURPOSE
Image-guided adaptive brachytherapy (IGABT) is a key component in the treatment of cervical cancer, but the nature of the clinical workflow makes it vulnerable to suboptimal plans, as the theoretical optimal plan depends heavily on organ configuration. Patient anatomy-based quality-assurance (QA) with overlap volume histograms (OVHs) is a promising tool to detect such suboptimal plans, and in this analysis its suitability as a multi-institutional clinical QA tool is investigated.
MATERIALS AND METHODS
A total of 223 plans of 145 patients treated in accordance with the current state-of-the-art IGABT protocols from UMC Utrecht (UMCU) and Erasmus MC (EMC) were included. Machine-learning models were trained to predict dose D to bladder, rectum, sigmoid and small bowel with the help of OVHs. For this strategy, points are sampled on the organs-at-risk (OARs), and the distances of the sampled points to the target are computed and combined in a histogram. Machine-learning models can then be trained to predict dose-volume histograms (DVHs) for unseen data. Single-center model robustness to needle use and applicator type and multi-center model translatability were investigated. Performance of models was assessed by the difference between planned (clinical) and predicted D values.
RESULTS
Intra-validation of UMCU data demonstrated OVH model robustness to needle use and applicator type. The model trained on UMCU data was found to be robust within the same protocol on EMC data, for all investigated OARs. Mean squared error between planned and predicted D values of OARs ranged between 0.13 and 0.40 Gy within the same protocol, indicating model translatability. For the former protocol cohort of Erasmus MC large deviations were found between the planned and predicted D values, indicating plan deviation from protocol. Mean squared error for this cohort ranged from 0.84 to 4.71 Gy.
CONCLUSION
OVH-based models can provide a solid basis for multi-institutional QA when trained on a sufficiently strict protocol. Further research will quantify the model's impact as a QA tool.
Topics: Brachytherapy; Female; Humans; Machine Learning; Organs at Risk; Radiotherapy Dosage; Radiotherapy Planning, Computer-Assisted; Uterine Cervical Neoplasms
PubMed: 35219799
DOI: 10.1016/j.radonc.2022.02.022