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BMC Oral Health Aug 2022Accurate integration of the dentitions with the face is essential in dental clinical practice. Here we introduce a noninvasive and efficient protocol to integrate the...
BACKGROUND
Accurate integration of the dentitions with the face is essential in dental clinical practice. Here we introduce a noninvasive and efficient protocol to integrate the digitized maxillary dentition with the three-dimensional (3D) facial photo using a prefabricated modified computer-aided design/computer-aided manufacture (CAD/CAM) facebow.
METHODS
To integrate the maxillary dentition with the 3D facial photo, the CAD/CAM facebow protocol was applied to 20 patients by taking a series of 3D facial photos in the clinic and integrating them in the laboratory. The integration accuracy of this protocol was compared with that of a valid 3D computed tomography (CT)-aided protocol concerning translational deviations of the landmarks representing maxillary incisors and maxillary first molars as well as the rotational deviation of the maxillary dentition. The intra- and inter-observer reproducibility was assessed, and the time of clinical operation and laboratory integration was recorded.
RESULTS
This facebow-aided protocol generated 3D fused images with colored faces and high-resolution dentitions, and showed high reproducibility. Compared with the well-established CT-aided protocol, the translational deviations ranged from 0 to 1.196 mm, with mean values ranging from 0.134 to 0.444 mm, and a relatively high integration error was found in the vertical dimension (Z) with a mean ± standard deviation (SD) of 0.379 ± 0.282 mm. Meanwhile, the rotational deviations ranged from 0.020 to 0.930°, with mean values less than 1°, and the most evident deviation was seen in pitch rotation with a mean ± SD of 0.445 ± 0.262°. The workflow took 4.34 ± 0.19 min (mins) for clinical operation and 11.23 ± 0.29 min for laboratory integration.
CONCLUSION
The present radiation-free protocol with the modified CAD/CAM facebow provided accurate and reproducible transfer of the digitized maxillary dentition to the 3D facial photo with high efficiency.
Topics: Computer-Aided Design; Dentition; Humans; Imaging, Three-Dimensional; Reproducibility of Results; Tomography, X-Ray Computed
PubMed: 36028874
DOI: 10.1186/s12903-022-02394-w -
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 -
Respiratory Care Apr 2021Treatments for ARDS that improve patient outcomes include use of lung-protective ventilation, prone ventilation, and conservative fluid management. Implementation of...
BACKGROUND
Treatments for ARDS that improve patient outcomes include use of lung-protective ventilation, prone ventilation, and conservative fluid management. Implementation of ARDS protocols via educational programs might improve adherence and outcomes. The objective of this study was to investigate the effects of an ARDS protocol implementation on outcomes and adherence with ARDS guidelines.
METHODS
This was a single-center, interventional, comparative study before and after protocol implementation. Staff education for the ARDS protocol was implemented between June 2014 and May 2015. A retrospective cohort analysis was conducted during between January 2012 and May 2014 (pre-protocol) and between June 2015 and June 2017 (post-protocol). A total of 450 subjects with ARDS were included. After propensity score matching, 432 subjects were analyzed. Of those, 330 subjects were treated after protocol implementation.
RESULTS
The median (interquartile range [IQR]) plateau pressure and tidal volume over the first 3 d decreased significantly after protocol implementation (30.5 [IQR 24.2-33] vs 25.5 [IQR 21.7-30], = .01 and 7.65 vs 7.4 mL/kg predicted body weight, = .032, respectively). The percentage of subjects with unsafe tidal volume (> 10 mL/kg predicted body weight) decreased (14.4% vs 5.8%, = .02). The percentage of subjects with safe plateau pressure (≤ 30 cm HO) increased (47.4% vs 76.5%, < .001). PEEP deviation from the ARDSNet PEEP/[Formula: see text] table was significantly lower after the implementation. Mortality at 28 and 90 days improved after implementation (53.9% vs 41.8% and 61.8% vs 48.2%, respectively). Adjusted odds ratios for 28-d and 90-d mortality were 0.47 (95% CI 0.28-0.78) and 0.45 (95% CI 0.27-0.76), respectively.
CONCLUSIONS
ARDS protocol implementation was associated with improved survival and rate of adherence.
Topics: Humans; Lung; Respiration, Artificial; Respiratory Distress Syndrome; Retrospective Studies; Tidal Volume
PubMed: 33051253
DOI: 10.4187/respcare.07999 -
JAMA Network Open Feb 2021The cohort size of phase 1 clinical trials and thus the timing of the interim decisions are typically prespecified in the trial protocol. During trial implementation,...
IMPORTANCE
The cohort size of phase 1 clinical trials and thus the timing of the interim decisions are typically prespecified in the trial protocol. During trial implementation, however, the cohort size often deviates from the planned one, which shifts the schedule of the interims. Despite its pervasiveness in phase 1 trials, the association of cohort size deviation with the operating characteristics of these trials is not clear.
OBJECTIVE
To explore the association between cohort size deviation and the operating characteristics of phase 1 clinical trials.
DESIGN, SETTING, AND PARTICIPANTS
In this cross-sectional simulation study, a review was conducted of 102 phase 1 dose-escalation trials published between January 2017 and May 2018 in 3 peer-reviewed journals (Journal of Clinical Oncology, Clinical Cancer Research, and Cancer). After exclusion of studies that did not report the cohort size, 45 trials remained for analysis. Based on the analysis results, a simulation study was performed to systematically investigate the association of cohort size deviation with the operating characteristics of the trials.
MAIN OUTCOMES AND MEASURES
The prevalence of cohort size deviation and the percentage of correct selection of the maximum tolerated dose.
RESULTS
Of the 45 reviewed trials, 10 (22.2%) adhered strictly to the planned cohort size. The simulation study showed that when cohort size deviation was random, it had little association with the performance of novel model-based and model-assisted designs (mean reduction in the percentage of correct selection of the maximum tolerated dose was 0.87 percentage point for the continual reassessment method and 0.84 percentage point for the bayesian optimal interval design). When the cohort size deviation was informative and made based on the observed data on toxicity (eg, if dose-limiting toxicity was observed, the size of the next or current cohort was reduced or expanded), the variation of the design performance increased. The range of the change in the percentage of correct selection was -3.7 to 1.3 percentage points for the continual reassessment method and -4.5 to 0 percentage points for the bayesian optimal interval design.
CONCLUSIONS AND RELEVANCE
The findings suggest that when novel phase 1 clinical trial designs are used, some cohort size deviation is acceptable and has little association with the performance of the designs. These deviations may be used by expert investigators to properly interpret the data, ensure safety, and leverage flexibility in the protocol.
Topics: Antineoplastic Agents; Bayes Theorem; Clinical Trial Protocols as Topic; Clinical Trials, Phase I as Topic; Computer Simulation; Cross-Sectional Studies; Humans; Maximum Tolerated Dose; Neoplasms; Research Design; Sample Size
PubMed: 33595664
DOI: 10.1001/jamanetworkopen.2020.37563 -
Gynecologic Oncology Oct 2023Prior to the COVID-19 pandemic, telehealth visits and remote clinical trial operations (such as local collection of laboratory tests or imaging studies) were...
OBJECTIVE
Prior to the COVID-19 pandemic, telehealth visits and remote clinical trial operations (such as local collection of laboratory tests or imaging studies) were underutilized in gynecologic oncology clinical trials. Current literature on these operational changes provides anecdotal experience and expert opinion with few studies describing patient-level safety data. We aimed to evaluate the safety and feasibility of telehealth and remote clinical trial operations during the COVID-19 Pandemic.
METHODS
Gynecologic oncology patients enrolled and actively receiving treatment on a clinical trial at a single, academic institution during the designated pre-Telehealth and Telehealth periods were identified. Patients with at least 1 provider or research coordinator telehealth visit were included. Patient demographics, health system encounters, adverse events, and protocol deviations were collected. Pairwise comparisons were performed between the pre-Telehealth and Telehealth period with each patient serving as their own control.
RESULTS
Thirty-one patients met inclusion criteria. Virtual provider visits and off-site laboratory testing increased during the Telehealth period. Delays in provider visits, imaging, and laboratory testing did not differ between time periods. Total and minor protocol deviations increased in incidence during the Telehealth period and were due to documentation of telehealth and deferment of non-therapeutic testing. Major protocol deviations, emergency department visits, admissions, and severe adverse events were of low incidence and did not differ between time periods.
CONCLUSIONS
Telehealth and remote clinical trial operations appeared safe and did not compromise clinical trial protocols in a small, single institutional study. Larger scale evaluations of such trial adaptations should be performed to determine continued utility following the Pandemic.
PubMed: 37659265
DOI: 10.1016/j.ygyno.2023.08.011 -
Therapeutic Innovation & Regulatory... Jul 2021Improving interpretation of existing guidelines and management of protocol deviation processes could increase process efficiencies and help reduce noise to support rapid...
Improving interpretation of existing guidelines and management of protocol deviation processes could increase process efficiencies and help reduce noise to support rapid identification of important protocol deviations. Towards this end, TransCelerate identified key principles to build upon and clarify the definition of a protocol deviation and developed a holistic approach to protocol deviation management. The approaches are flexible to suit a variety of indications, study designs, and investigational agents while also supporting consistent application within a study, program or organization.
Topics: Research Design
PubMed: 33782921
DOI: 10.1007/s43441-021-00269-w -
Perspectives in Clinical Research 2023Failure to stay within an ethics committee (EC)-approved protocol limits is termed protocol deviation or violation (PD/PV), depending on the seriousness of the...
INTRODUCTION
Failure to stay within an ethics committee (EC)-approved protocol limits is termed protocol deviation or violation (PD/PV), depending on the seriousness of the transgression and its attendant risks and/or harms. PD/PVs arise in the post-approval phase of the research and are often missed. Current guidelines expect ECs to detect, report and recommend suitable actions such that research participants' risks and harms are mitigated, to the extent possible.
OBJECTIVE
Yenepoya Ethics Committee-1 conducted an internal audit of ongoing postgraduate dissertations involving human participants to assess the occurrence of PD/PVs.
MATERIALS AND METHODS
54 out of 80 postgraduates responded to our request for filling out a self-reported checklist. These responses were followed up with physical verification of the protocol-related documents.
RESULTS
Protocol transgressions were classified as non-compliance (administrative issues), protocol deviations (minor transgressions with minimal or less than minimal increase in attendant risk to participants) and protocol violations (serious transgressions with more than minimal increase in attendant risk to participants). The non-compliances included non-reporting for audit and non-reporting of PDs. Protocol deviations included non-conformance to EC validity, sample size, approved methodology, informed consent process and documentation and suboptimal data storage. No protocol violations were observed.
CONCLUSION
We report PD/PVs from these 54 protocols - with our assessment on the negative impact it may have on scientific validity, harm to participants, EC functioning and credibility of the institution - in the hope that our readers appreciate this important aspect of the post-approval process in the functioning of an EC.
PubMed: 37325575
DOI: 10.4103/picr.picr_235_21 -
Cancer Jul 2022The European Organization for Research and Treatment of Cancer 22092-62092 STRASS trial failed to demonstrate the superiority of neoadjuvant radiotherapy (RT) over...
BACKGROUND
The European Organization for Research and Treatment of Cancer 22092-62092 STRASS trial failed to demonstrate the superiority of neoadjuvant radiotherapy (RT) over surgery alone in patients with retroperitoneal sarcoma. Therefore, an RT quality-assurance program was added to the study protocol to detect and correct RT deviations. The authors report results from the trial RT quality-assurance program and its potential effect on patient outcomes.
METHODS
To evaluate the effect of RT compliance on survival outcomes, a composite end point was created. It combined the information related to planning target volume coverage, target delineation, total dose received, and overall treatment time into 2 groups: non-RT-compliant (NRC) for patients who had unacceptable deviation(s) in any of the previous categories and RT-compliant (RC) otherwise. Abdominal recurrence-free survival (ARFS) and overall survival were compared between the 2 groups using a Cox proportional hazard model adjusted for known prognostic factors.
RESULTS
Thirty-six of 125 patients (28.8%) were classified as NRC, and the remaining 89 patients (71.2%) were classified as RC. The 3-year ARFS rate was 66.8% (95% confidence interval [CI], 55.8%-75.7%) and 49.8% (95% CI, 32.7%-64.8%) for the RC and NRC groups, respectively (adjusted hazard ratio, 2.32; 95% CI, 1.25-4.32; P = .008). Local recurrence after macroscopic complete resection occurred in 13 of 89 patients (14.6%) versus 2 of 36 patients (5.6%) in the RC and NRC groups, respectively.
CONCLUSIONS
The current analysis suggests a significant benefit in terms of ARFS in favor of the RC group. This association did not translate into less local relapses after complete resection in the RC group. Multidisciplinary collaboration and review of cases are critical to avoid geographic misses, especially for rare tumors like retroperitoneal sarcoma.
Topics: Disease-Free Survival; Guideline Adherence; Humans; Neoadjuvant Therapy; Neoplasm Recurrence, Local; Proportional Hazards Models; Randomized Controlled Trials as Topic; Retroperitoneal Neoplasms; Sarcoma; Soft Tissue Neoplasms; Survival Rate
PubMed: 35536104
DOI: 10.1002/cncr.34239 -
Nihon Hoshasen Gijutsu Gakkai Zasshi Oct 2022There are problems with dose management in X-ray computed tomography (CT) because the protocol used for any examination is not always in the same scan range. The purpose...
PURPOSE
There are problems with dose management in X-ray computed tomography (CT) because the protocol used for any examination is not always in the same scan range. The purpose of this study was to investigate the usefulness of setting the CT protocol based on the scan range.
METHODS
We evaluated the examination data of patients who underwent plain CT based on a scan range of chest to pelvis and abdomen to pelvis. The previous protocol [Chest-Abdomen Routine] was changed to the current protocols [Chest_Abdomen] and [Chest_Pelvis], and the previous protocol of [Abdomen Routine] was changed to the current protocols [Abdomen] and [Abdomen_Pelvis]. Examination data of height, scan length, volume CT dose index (CTDI), and dose length product (DLP) were obtained from digital imaging and communications in medicine, and radiation dose structured report using Radimetrics. The relationship between patient height and scan range, and CTDI and DLP was indicated in a scatter plot. Standard deviation (SD) of scan length and DLP were compared between current and previous protocols. Outliers were defined as the data exceeding average ±2SD.
RESULTS
The SD of scan length decreased by 77.1% on abdomen to pelvis, and the SD of DLP decreased by 65.2% on abdomen to pelvis. The causes of the outliers were CT scan range, scan parameter, arm position, metal implants, and body thickness of patients.
CONCLUSION
Setting CT protocols based on the scan range reduced SD of scan length and DLP. It was helpful for reducing the number of scan range outliers and analyzing the cause of outliers.
Topics: Humans; Radiation Dosage; Tomography, X-Ray Computed; Pelvis; Thorax; Abdomen
PubMed: 36031372
DOI: 10.6009/jjrt.2022-1131 -
Cureus Oct 2022In today's world, the upper cross syndrome is growing more common and becoming very prevalent among dental undergraduate practitioners. One of the most important...
Measuring the Efficacy of Myofascial Rollers and Post-isometric Relaxation Technique in Relieving Pain Intensity and Postural Deviation Using Plumb Line Assessment for the Treatment of Upper Cross Syndrome in Dental Undergraduate (UG) Students.
BACKGROUND
In today's world, the upper cross syndrome is growing more common and becoming very prevalent among dental undergraduate practitioners. One of the most important conditions for which dentists seek physiotherapy treatment is neck pain. It is characterized by overactive pectoralis and trapezius muscles. It is frequently linked to poor posture in dental students' daily life, causing them to miss their work.
OBJECTIVES
The first objective of our study was to find the efficacy of myofascial rollers and post-isometric relaxation technique along with conventional therapy for pain relief and correction of postural deviation in undergraduate dental students. And, the second objective of the study was to compare the effect of myofascial rollers and post-isometric relaxation techniques in upper cross syndrome.
METHODS
The study was conducted with pre-test and post-test methods. The study consisted of 80 participants who were included based on our inclusion and exclusion criteria. The study sample was randomly assigned into two groups. Each group consisted of a total of 40 participants. Group A was treated using myofascial rollers and hot packs, and Group B was treated using the post-isometric relaxation technique and hot packs. Patients were asked to mark their intensity of pain on the Numerical Pain Rating Scale and an assessment of postural deviations (in mm) was noted through a plumb line in the posture grid. Posture assessment was done in lateral view. The protocol covered four weeks of treatment based on the defined protocol. Finally, the t-square test and Chi-square test were used to compare the difference in the result. Also, the level of significance was kept at <0.05.
RESULT
Statistical analysis was done using descriptive and inferential statistics using student paired, unpaired, and chi-square test. IBM SPSS Statistics for Windows, Version 27.0 (Released 2020; IBM Corp., Armonk, New York, United States) was used. The Numerical Pain Rating Scale showed mean deviations of (4.15±1.29) for Group A and (3.30±1.01) for Group B. Plumb line assessment showed mean deviations of (9.09±4.31) for Group A and (6.33±2.36) for Group B. Also, Numerical Pain Rating Scale showed (t=3.26, p=0.002) and Plumb line deviation showed (t=3.57, p=0.001).
CONCLUSION
Through our study, we conclude that statistically no significant differences were found in pre-intervention and post-intervention, but myofascial rollers gave better results as compared to the post-isometric relaxation technique in alleviating pain and correcting postural deviation.
PubMed: 36337788
DOI: 10.7759/cureus.29831