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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 -
Therapeutic Innovation & Regulatory... Mar 2021The ability to detect patterns and trends across protocol deviations (PDs) is key to ensure high data quality and sufficient oversight of patient safety. In clinical... (Review)
Review
The ability to detect patterns and trends across protocol deviations (PDs) is key to ensure high data quality and sufficient oversight of patient safety. In clinical trial operations, some business processes and work instructions limit efficient protocol deviation trending because a majority of protocol deviations are left unclassified. When this occurs, it restricts clinical teams from determining systemic issues or signals in the data. The unstructured text in protocol deviation descriptions is an important component of trial operation knowledge. Natural language processing (NLP) can make protocol deviation descriptions more accessible and can support information extraction and trending analysis. This paper reviews how the natural language processing techniques of Term-Frequency Inverse-Document-Frequency (TF-IDF) combined with the supervised machine learning model of Support Vector Machines (SVM) and word embedding approaches such as word2vec can be used to categorize/label protocol deviations across multiple therapeutic areas. NLP is a key tool that will lead to more data driven decisions in clinical trial operations.
Topics: Humans; Natural Language Processing
PubMed: 33125616
DOI: 10.1007/s43441-020-00236-x -
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 -
The Journal of Prosthetic Dentistry Apr 2021Patients and clinicians are aware of the efficacy and benefits of complete dentures, but evidence regarding their longevity is limited. (Meta-Analysis)
Meta-Analysis Review
STATEMENT OF PROBLEM
Patients and clinicians are aware of the efficacy and benefits of complete dentures, but evidence regarding their longevity is limited.
PURPOSE
The purpose of this systematic review was to examine the literature describing the longevity of complete dentures and to review variations in longevity by denture type and duration of follow-up.
MATERIAL AND METHODS
Four electronic databases were searched by using key terms: MEDLINE, CINAHL (EBSCO), Dentistry and Oral Sciences Databases, and The Cochrane Library. Studies meeting the inclusion criteria were reviewed according to an established protocol and data extracted. Reference lists of identified studies were examined. Risk of bias was assessed by using the AXIS tool. Weighted means and weighted standard deviations were calculated. Pooled complete denture failure proportions were estimated by using random effects models based on the DerSimonian and Laird method.
RESULTS
The search yielded 21 607 unique abstracts, of which 273 met the inclusion criteria. Assessment of the full-text articles reduced this number to 42. Of these, 24 studies were rated as having low risk of bias and 18 as very low. The weighted mean ±standard deviation longevity of maxillary complete dentures was 10.3 ±3.8 years, of mandibular dentures was 8.6 ±2.6 years, and of both maxillary and mandibular dentures was 10.8 ±4.7 years. The pooled failure proportion for complete dentures observed for 2 years or less was 0.05 (95% confidence interval [CI]: 0.00-0.10), 5 to 6 years was 0.12 (95% CI: 0.08-0.16), and 10 years or more was 0.41 (95% CI: 0.28-0.53).
CONCLUSIONS
Complete dentures, fabricated primarily in university settings, were found to have a weighted mean ±standard deviation longevity of 10.1 ±4.0 years. The failure rate of these prostheses increased with denture age, and the longevity of maxillary dentures was greater than that of mandibular dentures.
Topics: Denture, Complete; Humans; Mandible; Maxilla
PubMed: 32359852
DOI: 10.1016/j.prosdent.2020.02.019 -
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 -
Radiotherapy and Oncology : Journal of... Jan 2022Quality assurance (QA) practices improve the quality level of oncology trials by ensuring that the protocol is followed and the results are valid and reproducible. This... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
Quality assurance (QA) practices improve the quality level of oncology trials by ensuring that the protocol is followed and the results are valid and reproducible. This study investigated the utilization of QA among randomized controlled trials that involve radiotherapy (RT).
METHODS AND MATERIALS
We searched ClinicalTrials.gov in February 2020 for all phase III oncology randomized clinical trials (RCTs). These trials were screened for RT-specific RCTs that had published primary trial results. Information regarding QA in each trial was collected from the study publications and trial protocol if available. Two individuals independently performed trial screening and data collection. Pearson's Chi-square tests analyses were used to assess factors that were associated with QA inclusion in RT trials.
RESULTS
Forty-two RCTs with RT as the primary intervention or as a mandatory component of the protocol were analyzed; the earliest was started in 1994 and one trial was still active though not recruiting. Twenty-nine (69%) trials mandated RT quality assurance (RTQA) practices as part of the trial protocol, with 19 (45%) trials requiring institutional credentialing. Twenty-one (50%) trials published protocol deviation outcomes. Clinical trials involving advanced radiation techniques (IMRT, VMAT, SRS, SBRT) did not include more RTQA than trials without these advanced techniques (73% vs. 65%, p = 0.55). Trials that reported protocol deviation outcomes were associated with mandating RTQA in their protocols as compared to trials that did not report these outcomes (100% vs. 38%, p < 0.001).
CONCLUSIONS
There is a lack of RTQA utilization and transparency in RT clinical trials. It is imperative for RT trials to include increased QA for safe, consistent, and high-quality RT planning and delivery.
Topics: Credentialing; Humans; Neoplasms; Quality Assurance, Health Care; Radiation Oncology
PubMed: 34838891
DOI: 10.1016/j.radonc.2021.11.018 -
CoDAS 2022Verify and compare vocal deviation in quality, vocal symptoms and reflux symptom index in patients with clinical diagnosis of laryngopharyngeal reflux (LPR).
PURPOSE
Verify and compare vocal deviation in quality, vocal symptoms and reflux symptom index in patients with clinical diagnosis of laryngopharyngeal reflux (LPR).
METHODS
100 individuals of both genders participated in this prospective study, aged between 18 and 60 years old, who presented signs of LPR in the nasofibrolaryngological exam. Participants answered the Reflux Symptom Index (RSI) questionnaire to determine the reflux index and the Voice Symptom Scale (VoiSS). Their voices were recorded for the auditory-perceptual assessment. Three speech therapists with voice experience were contacted and the most reliable one was maintained.
RESULTS
100 examined voices, 34 were classified as adapted and 66 as deviated. The predominant vocal quality type was rough and a slight degree of deviation. The average score on VoiSS and RSI of individuals with deviated voice is significantly higher than the adapted voice group on both protocols (p<0.01). The symptom reported with most frequency and intensity, in both analyses, was throat clearing. There were statistically significant differences once analyzed the vocal quality types by pairs: rough-adapted (p=0.0021) and tense-adapted (p=0.0075) on VoiSS, and rough-adapted (p=0.001) on RSI.
CONCLUSION
Individuals with deviated voice reported higher occurrence of LPR related vocal signals and symptoms measured by VoiSS and RSI. The numerous theories about the disease do not make possible a single conclusion on the subject. Further studies are needed in the area to assist the professional in the diagnosis and treatment of the RLF patient.
Topics: Adolescent; Adult; Female; Humans; Laryngopharyngeal Reflux; Male; Middle Aged; Prospective Studies; Surveys and Questionnaires; Voice; Voice Quality; Young Adult
PubMed: 35239772
DOI: 10.1590/2317-1782/20212019065 -
Applied Radiation and Isotopes :... Mar 2022Thermoluminescence (TL) dating is one of the most significant chronological tools used in Quaternary research. However, for changes in the characteristics of quartz, the... (Review)
Review
Thermoluminescence (TL) dating is one of the most significant chronological tools used in Quaternary research. However, for changes in the characteristics of quartz, the larger deviation is still a problem in TL dating, especially with the single-aliquot regeneration-does (SAR) procedure. In the SAR-TL protocol, changes in the characteristics of quartz inevitably cause a shift in the TL peak position and a reduction in the sensitivity of the TL peak during repetitive thermal treatment. In this paper, we studied the optimal TL parameters to minimize the effect of the above problems for TL dating. Based on the optimization experiment combining OSL and TL measurements, the optimal preheat temperature was found to be 300 °C for both silt-sized grains and sand-sized grains, which eliminates the remainder of the 325 °C TL signals and inhibits the 375 °C TL peak position shift. Referring to the test does in SAR-OSL dating protocol, the optimal test doses, 200 Gy and 250 Gy for the silt-sized grains and sand-sized grains respectively, were determined to correct the reduction in TL sensitivity, and they were added to improve the SAR-TL protocol. The improved SAR-TL protocol with the optimal measurement parameters, which we called the accurate-parametric SAR-TL protocol, improves the accuracy of quartz TL dating and expands the range of accurate TL dating. For the experimental doses of 400 Gy and 700 Gy, the relative error of D obtained by the accurate-parametric SAR-TL protocol was less than ±5.5% for both silt-sized grains and sand-sized grains. In addition, we discussed the application conditions of the accurate-parametric SAR-TL protocol and the method that obtains the same level of thermal lag for different luminescence measurement equipment.
PubMed: 34968882
DOI: 10.1016/j.apradiso.2021.110072 -
Journal of Clinical Pharmacy and... Mar 2022Paediatric intensive care patients are at high risk for prescription errors due to the more complex process of medication prescribing. Clinical decision support systems... (Observational Study)
Observational Study
WHAT IS KNOWN AND OBJECTIVE
Paediatric intensive care patients are at high risk for prescription errors due to the more complex process of medication prescribing. Clinical decision support systems (CDSS) have shown good results in effectively reducing prescription errors. A specific dosing CDSS was developed that can check and suggest normal dose, dose limits and administration frequencies. This study aimed to assess the effect of this CDSS on protocol deviation (as measure of prescription error) types and frequency in a paediatric intensive care unit (PICU).
METHODS
A retrospective observational study was conducted evaluating 9342 prescriptions in a 4-month period before and after the implementation of a CDSS in the PICU of the University Medical Center Utrecht. Medication forms were reviewed to identify protocol deviations (and therefore possible prescription errors). The incidence and nature of deviations from evidence-based protocols that were unintended and needed to be adjusted, were determined.
RESULTS AND DISCUSSION
In the period before the dosing CDSS, we identified 45 protocol deviations in 5034 prescriptions (0.89%), 28 of which could not be justified (0.56%) and 11 needed to be adjusted (0.22%). In the period after the implementation of the CDSS, there were 21 protocol deviations in 4308 prescriptions (0.49%) of which ten without a valid reason (0.23%) of which two were adjusted (0.05%).
WHAT IS NEW AND CONCLUSION
The specific dosing CDSS was able to significantly reduce unintentional prescription dose deviations and the number of prescriptions that needed to be adjusted, in an existing low incidence situation.
Topics: Child; Decision Support Systems, Clinical; Drug Prescriptions; Humans; Incidence; Intensive Care Units, Pediatric; Medication Errors
PubMed: 34734650
DOI: 10.1111/jcpt.13562 -
European Journal of Dental Education :... Aug 2022This study measured the duration, deviation and operator's perception of implant placement by fully guided (FG), pilot-guided (PG) and freehand (FH) protocols by...
INTRODUCTION
This study measured the duration, deviation and operator's perception of implant placement by fully guided (FG), pilot-guided (PG) and freehand (FH) protocols by postgraduate students with minimal implant experience.
MATERIALS AND METHODS
Twenty postgraduate students participated in the study. Half of them placed single anterior (S-Ant) and single posterior (S-Post) implants, and the other half placed anterior (B-Ant) and posterior (B-Post) implants in a wide edentulous area. The PG placement involved surgical guides that only controlled pilot drilling, whilst the FG placement controlled all the drilling steps and implant placement. The duration of implant placement and the operator's perception (ease of drilling, ease of implant placement and operator's preference) were measured. The deviations of placed implants were quantified by measuring the trueness and angulation deviations in relation to the planned implants.
RESULTS
The PG placement was the quickest for inserting implants, followed by FG and FH placements, respectively (p < .05). The location of the implant had influenced the duration of implant placement only for the PG placement. In relation to ease of drilling, ease of implant placement and operator's preference, there was no significant difference amongst the different placement protocols or implant locations. The FG placement was associated with least deviations, followed by PG and FH placements, respectively (p < .05).
CONCLUSIONS
In the hands of postgraduate students with minimal implant experience, FG and PG placements reduced the implant placement duration in comparison with FH placement. The FG placement was consistently more accurate followed by PG placement.
Topics: Computers; Cone-Beam Computed Tomography; Dental Implants; Education, Dental; Humans; Imaging, Three-Dimensional; Perception; Surgery, Computer-Assisted
PubMed: 34797018
DOI: 10.1111/eje.12724