-
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 -
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 -
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 -
Evidence-based Dentistry Sep 2022Study design Retrospective cohort study.Cohort selection and data analysis In total, 89 implants were placed in 34 patients (19 men and 15 women; average 62.1 years of... (Review)
Review
Study design Retrospective cohort study.Cohort selection and data analysis In total, 89 implants were placed in 34 patients (19 men and 15 women; average 62.1 years of age) using computer-guided implant surgery with cone beam computed tomography (CBCT). All patients included in this study were adults and the computed-guided implant surgery was planned according to a digital guide protocol based on CBCT. Group 1 patients received the implants with the guide and flapped surgical approach, Group 2 with the guide and flapless approach. Group 3 was the drop-out group which included other patients in who the implant could not be placed according to the guide. CBCT data from before and after the surgeries were superimposed to evaluate the accuracy of implant positioning among all the groups. The differences in distance of the entry point (deviation distance) and in the degree of the insertion angle (deviation angle) were measured on the superimposed CBCT. Statistical analysis was performed with SPSS software and an independent sample t-test was done to analyse the difference of measurements among the groups.Results The authors observed greater accuracy in Group 2 in terms of deviation distance and angulation when compared to Group 1. The deviated position of the implant fixtures was greater in the drop-out group when compared to the guided groups in terms of the displacement of entrance point and the degree of insertion.Conclusions The authors concluded that flapless guided implant surgery is more accurate than flap guided implant surgery. The results of this study can be useful to clinicians in making decisions between flapless surgical approach and flapped approach when using a guide for implant placement.
Topics: Adult; Computers; Dental Implantation, Endosseous; Dental Implants; Female; Humans; Male; Retrospective Studies; Surgery, Computer-Assisted
PubMed: 36151285
DOI: 10.1038/s41432-022-0813-2 -
Shanghai Kou Qiang Yi Xue = Shanghai... Feb 2021Judged from the clinical manifestations, etiological mechanisms and jaw morphological structures, malocclusions with mandibular deviation and facial asymmetry are...
Judged from the clinical manifestations, etiological mechanisms and jaw morphological structures, malocclusions with mandibular deviation and facial asymmetry are classified into three main categories, i.e., those with mandibular positioning factors, those with mandibular condyle defects, and those with jaw congenital deformities. In the first category, three subtypes, including mandibular rotation caused by dentitional irregularities, by dental compensation and by habitual posturing, are further defined. In the second category, mandibular deviation caused by condylar asymmetrical resorption or hyperplasia are defined as the two subtypes. The third category is further divided into two subtypes, i.e., jaw and facial asymmetry resulting from maxillary or mandibular structural deformities. The prime goal of orthodontic therapy is to displace and restore the deviated mandible to its right position, followed by correction of occlusal intercuspation. As an important procedure of the whole treatment protocol, It is critical to detect and localize the correct mandibular position by manipulation and then register it by wax pattern and articulator transferring. For the cases with mandibular functional elements and condylar asymmetrical length, the treatment modalities include orthopedic repositioning of the mandible by using occlusal and bite plane, SGTB and SGHB therapies; for cases with growth and developmental anomalies, orthognathic intervention should be an optimal solution.
Topics: Dental Occlusion; Facial Asymmetry; Humans; Malocclusion; Mandible; Mandibular Condyle
PubMed: 33907770
DOI: No ID Found -
Indian Journal of Pediatrics Dec 2022To develop and validate a mobile application-based tool for the management guidance of children and adolescents with diabetic ketoacidosis (DKA).
OBJECTIVE
To develop and validate a mobile application-based tool for the management guidance of children and adolescents with diabetic ketoacidosis (DKA).
METHODS
The study involved the development of a mobile application-based tool for DKA management in accordance with the International Society of Pediatric and Adolescent Diabetes (ISAPD) guidelines, 2018. The impact of the mobile application in preventing protocol deviation and resultant complications was assessed. Case records of 70 children and adolescents [39 boys, 8.9 (4.1) y of age] with severe DKA managed in the authors' intensive care unit were examined. The application guidance and real-time management were compared to the standard protocol.
RESULTS
Protocol deviations were observed in 58 (82.9%), with two or more errors in 28 (40%). These included lack of initial fluid bolus (4, 5.7%), excessive fluid supplementation (8, 11.4%), inadequate initial fluid (25, 35.7%) and potassium supplementation (13, 18.6%), delayed response to fall in potassium (15, 21.4%) and glucose levels (24, 34.3%), and erroneous insulin administration (19, 27.1%). These errors contributed to 42.1% of severe hypokalemia and 56% of significant hypoglycemia episodes. The mobile application guidance was in accordance with the protocol in all the case scenario.
CONCLUSION
Deviation from the management protocol is common in DKA and associated with adverse outcomes. Mobile application guidance is expected to reduce the protocol deviation with a potential of improving outcomes.
Topics: Male; Adolescent; Child; Humans; Diabetic Ketoacidosis; Mobile Applications; Retrospective Studies; Insulin; Potassium; Diabetes Mellitus
PubMed: 35653075
DOI: 10.1007/s12098-022-04159-3 -
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 -
Family Practice Mar 2022Chronic benzodiazepine use is a challenge in primary care practice. Protocols to support safe discontinuation are still needed, especially in countries with high... (Clinical Trial)
Clinical Trial
BACKGROUND
Chronic benzodiazepine use is a challenge in primary care practice. Protocols to support safe discontinuation are still needed, especially in countries with high utilization rates.
OBJECTIVES
To evaluate the feasibility, effectiveness, and safety of a benzodiazepine discontinuation protocol in primary care setting.
METHODS
Nonrandomized, single-arm interventional study, at primary care units. Family physicians (FPs) recruited patients (18-85 years-old) with benzodiazepine dependence and chronic daily use ≥3 months. Patients with daily dosages ≥30 mg diazepam-equivalent, taking zolpidem, with a history of other substance abuse or major psychiatric disease were excluded. After the switch to diazepam, the dosage was gradually tapered according to a standardized protocol. Primary endpoint was the percentage of patients who stopped benzodiazepine at the intervention last visit. Dosage reduction, withdrawal symptoms, patients' and FPs' satisfaction with the protocol were evaluated.
RESULTS
From 66 enrolled patients (74% female; 66.7% aged >64 years; median time of benzodiazepine use was 120 months), 2 withdrew due to medical reasons and 3 presented protocol deviations. Overall, 59.4% of participants successfully stopped benzodiazepine (60.7% when excluding protocol deviations). Men had higher probability of success (relative risk = 0.51, P = 0.001). A total of 31 patients reported at least 1 withdrawal symptom, most frequently insomnia and anxiety. Most of participating FP considered the clinical protocol useful and feasible in daily practice. Among patients completing the protocol, 77% were satisfied. For the patients who reduced dosage, 85% kept without benzodiazepines after 12 months.
CONCLUSION
The discontinuation protocol with standardized dosage reduction was feasible at primary care and showed long-term effectiveness.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Anxiety Agents; Benzodiazepines; Diazepam; Female; Humans; Male; Middle Aged; Primary Health Care; Substance Withdrawal Syndrome; Substance-Related Disorders; Young Adult
PubMed: 35196378
DOI: 10.1093/fampra/cmab143 -
Clinical Nutrition (Edinburgh, Scotland) Apr 2020Esophagectomy is associated with high postoperative morbidity rates, which can result in decreased quality of life and impaired recovery. Implementation of enhanced...
BACKGROUND
Esophagectomy is associated with high postoperative morbidity rates, which can result in decreased quality of life and impaired recovery. Implementation of enhanced recovery after surgery (ERAS) protocols have made a great impact in optimizing postoperative recovery. However, the best timing to start oral intake is still unclear. Conservative feeding protocols have been developed with a nil-by-mouth period in the first postoperative days to reduce postoperative complication rates (e.g. anastomotic leakage and pneumonia). This study aimed to evaluate adherence to the feeding protocol following minimal invasive esophagectomy and identify reasons for protocol deviation.
METHODS
All consecutive patients who underwent an esophagectomy with gastric tube reconstruction between 2014 and 2016 in two high-volume hospitals in the Netherlands were retrospectively analyzed. All patients were planned to receive enteral tube feeding via jejunostomy directly after surgery. Data regarding postoperative feeding related symptoms (e.g. nausea, vomiting, regurgitation) and adherence to the postoperative feeding protocol were gathered.
RESULTS
A total of 186 patients were included. Feeding protocol deviation was observed in 109 patients (59%) and was significantly more common in patients with anastomotic leakage, chyle leakage, and acute respiratory distress. Postoperative feeding related symptoms were present in 107 patients (58%) and were significantly more common in female patients and patients with a cervical anastomosis.
CONCLUSION
In this study, more than half of the patients deviated from the intended feeding protocol after esophagectomy. Postoperative complications appeared to be the main reason for feeding protocol deviation. This study shows that a predefined feeding protocol including an oral fasting period is often violated because of complications.
Topics: Administration, Oral; Aged; Clinical Protocols; Enteral Nutrition; Esophagectomy; Female; Humans; Length of Stay; Male; Middle Aged; Netherlands; Postoperative Care; Practice Guidelines as Topic; Prospective Studies; Retrospective Studies; Sex Factors; Treatment Outcome
PubMed: 31174943
DOI: 10.1016/j.clnu.2019.05.018 -
Therapeutic Innovation & Regulatory... Nov 2016The DIA's Good Clinical Practice and Quality Assurance Community (DIA GCP/QA) created a working group to develop templates for a protocol deviation standard operating...
BACKGROUND
The DIA's Good Clinical Practice and Quality Assurance Community (DIA GCP/QA) created a working group to develop templates for a protocol deviation standard operating procedure (SOP) and protocol deviation handling plan (PDHP).
METHODS
The working group consisted of QA auditors, data managers, statisticians, and clinical monitors from several pharmaceutical companies, academia, and independent auditing firms. Various examples of standard operating procedures, data handling plans, and auditing plans were examined, and the core elements extracted into the initial PD SOP and PDHP templates. The draft templates were presented at a workshop at the DIA 51st Annual Meeting held in June 2015 in Washington, DC, and feedback was incorporated. The workshop came at the heels of a previously published position paper, "The Lifecycle and Management of Protocol Deviations."
RESULTS
The PD SOP and the PDHP templates are presented in this article. They are a starting point, and each company will need to modify to suit its individual needs.
CONCLUSIONS
This article expands on the position paper to include concrete tools for the management of protocol deviations, including best practices for detection, classification, mitigation, and management of protocol deviations with a goal to reduce the impact on subject safety and data integrity.
PubMed: 30231739
DOI: 10.1177/2168479016647987