BACKGROUND

Feasibility studies are a necessary first step in assessing the practicality of methods and procedures used in a more extensive study. Others emphasize that feasibility studies aim to test the practical aspects of a future study and use the results to inform modifications that can enhance the study design and increase the chances of success in the more extensive study. Before conducting the main study, we rigorously refined data collection procedures based on the best available evidence, informed by the scoping review, expert consultation, and pilot testing.

To evaluate the feasibility and practicality of the proposed research methodology and to identify and address potential challenges associated with data collection. The specific objective is to determine the intra-rater reliability in determining MVIC, which is part of the procedure in the sEMG protocol.

This study is composed of two phases: (Phase 1) a pragmatic pilot study using an experienced biomechanist to refine the protocol. Thorough preparation, including a dry run and expert review, preceded the pilot study. (Phase 2) a preliminary testing phase to evaluate the protocol and to assess the intra-rater reliability of the MVIC used in the sEMG protocol. A high speed treadmill, Nexus software, Vicon and Delsys sEMG systems were used to capture kinematic and muscle activity data during high-speed running, enabling a comprehensive biomechanical analysis.

The final protocol underwent a feasibility and acceptability assessment based on five pre-defined metrics: recruitment efficacy, optimization of data acquisition methodologies, data integrity and completeness, procedural tolerability, and resource allocation efficiency. Pilot testing anomalies and their respective corrective actions were systematically documented. Furthermore, the intra-rater reliability of the maximum voluntary isometric contraction (MVIC) measurement exhibited a range from moderate to excellent, as determined by statistical analysis.

This study successfully demonstrated the feasibility and practicality of our research methods. We evaluated all identified parameters and completed the assessments on schedule. The feasibility study proved valuable in identifying and addressing challenges encountered during data collection, such as equipment malfunctions and logistical hurdles. The study also demonstrated a moderate to excellent intra-rater reliability of MVIC assessment.

Objectives: The Bioavailability/Bioequivalence Unit (BA/BE Unit) of the Department of Pharmacology and Toxicology, College of Medicine, University of the Philippines Manila which has not been operational since 2012, is due for renewal of its accreditation. To date, there are only three Philippine Food and Drug Administration-accredited laboratories that perform bioequivalence studies in the Philippines. One of the prerequisites of registering specific generic medicines is the conduct of Bioequivalence (BE) studies which are performed to ensure that the generic drug is at par with the innovator drug. Thus, this study aimed to determine the feasibility of re-establishing the BA/BE Unit as a bioequivalence testing center. Methods: The feasibility study done is a qualitative descriptive analysis based on expansive literature review and performance of SWOT analysis within the BA/BE unit. Literatures were selected based on its assessed relevance to the study. The databases checked were PubMed and Google Scholar. The terms used were from the Medical Subject Heading (MeSH) including feasibility studies, therapeutic equivalency, and generic drugs. Literature review was performed on the factors affecting the four types of feasibility studies (market, technical, financial, and organizational). A SWOT analysis of the BA/BE Unit was done through the review of records and documents of previous BE studies and focus group discussion among the BA/BE Unit team members. Results: The BA/BE Unit conducted 24 bioequivalence studies from 2006-2009 and still receives inquiries from drug companies. It implements its QMS throughout the pre-analytical, analytical, and post-analytical stages of the workflow. Its organizational structure consists of qualified professionals with updated GCP and GLP certificates. Because of the adequately equipped facility, lower honoraria for government-employed personnel, and lower expenses for laboratories and in-patient admissions, the cost of conducting a bioequivalence study in the BA/BE Unit will be lower than in other BE centers. Conclusion Based on the SWOT analysis and market, technical, financial, and organizational considerations, reestablishing the BA/BE Unit as a bioequivalence testing center is feasible.
Feasibility Studies ; Therapeutic Equivalency ; Drugs, Generic

OBJECTIVES: This study aimed to investigate the feasibility of measuring the soft tissue height of bone cristae around implant by digital method. METHODS: A total of 36 patients with dental implants were selected from the Dental Medicine Center of the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) from August 2022 to December 2022. A total of 43 dental implants were enrolled. All postoperative cone beam CT (CBCT) imaging data and intraoral digital impressions obtained before surgery were immediately obtained by the patients on the day of completion of oral implant surgery and they were imported into oral implant surgery planning software for image fitting. Then, virtual implants of the same specification were placed in the planting area, and the implant position was adjusted to overlap with the implant shadow in the CBCT image. Supracrestal tissue height (STH) was measured at the implant view interface (digital group). During the operation, implant holes were prepared step by step in accordance with the standard preparation method, and implants were implanted. The upper edge of the implant was flushed with the crest of the alveolar ridge. STH was measured by perio-dontal probing (periodontal probe group). Paired t-test was used to compare the STH differences between the digital and periodontal probe groups. Bland-Altman test was used to analyze the consistency of the two methods. Intra-group correlation coefficient (ICC) was used to verify the reliability of the results measured by different surveyors using di-gital methods. RESULTS: No statistical significance was observed in the STH difference between the two methods (P>0.05). Bland-Altman test showed good consistency between the two methods, but the measurement of mandibular posterior teeth showed that the results of periodontal probe were greater than those of digital method. The ICC and 95%CI of the STH results measured digitally by different surveyors are 0.992 (0.986-0.996). CONCLUSIONS The digital me-thod is in good agreement with the periodontal probe method in measuring the soft tissue height of the bone cristae around the implant.
Humans ; Alveolar Process/diagnostic imaging* ; Cone-Beam Computed Tomography/methods* ; Dental Implants ; Feasibility Studies ; Reproducibility of Results ; Tooth/diagnostic imaging*

OBJECTIVE: To evaluate the feasibility of S₂ alar iliac screw insertion in Chinese children using computerized three-dimension reconstruction and simulated screw placement technique, and to optimize the measurement of screw parameters. METHODS: A total of 83 pelvic CT data of children who underwent pelvic CT scan December 2018 to December 2020 were retrospectively analyzed, excluding fractures, deformities, and tumors. There were 44 boys and 39 girls, with an average age of (10.66±3.52) years, and were divided into 4 groups based on age (group A:5 to 7 years old;group B:8 to 10 years old;group C:11-13 years old;group D:14 to 16 years old). The original CT data obtained were imported into Mimics software, and the bony structure of the pelvis was reconstructed, and the maximum and minimum cranial angles of the screws were simulated in the three-dimensional view with the placement of 6.5 mm diameter S2 alar iliac screws. Subsequently, the coronal angle, sagittal angle, transverse angle, total length of the screw, length of the screw in the sacrum, width of the iliac, and distance of the entry point from the skin were measured in 3-Matic software at the maximum and minimum head tilt angles, respectively. The differences among the screw parameters of S₂ alar iliac screws in children of different ages and the differences between gender and side were compared and analyzed. RESULTS: In all 83 children, 6.5 mm diameter S₂ iliac screws could be placed. There was no significant difference between the side of each screw placement parameter. The 5 to 7 years old children had a significantly smaller screw coronal angle than other age groups, but in the screw sagittal angle, the difference was more mixed. The 5 to 7 years old children could obtain a larger angle at the maximum head tilt angle of the screw, but at the minimum cranial angle, the larger angle was obtained in the age group of 11 to 13 years old. There were no significant differences among the age groups. The coronal angle and sagittal angle under maximum cephalic angle and minimum cranial angle of 5 to 7 years old male were (40.91±2.91)° and (51.85±3.75)° respectively, which were significantly greater than in female. The coronal angle under minimum cranial angle was significantly greater in girls aged 8-10 years old than in boys. For the remaining screw placement angle parameters, there were no significant differences between gender. The differences in the minimum iliac width, the screw length, and the length of the sacral screws showed an increasing trend with age in all age groups. The distance from the screw entry point to the skin in boys were significantly smaller than that of girls. The minimum width of the iliac in boys at 14 to 16 years of age were significantly wider than that in girls at the same stage. In contrast, in girls aged 5 to 7 years and 11 to 13 years, the screw length was significantly longer than that of boys at the same stage. CONCLUSION The pelvis of children aged 5 to 16 years can safely accommodate the placement of 6.5 mm diameter S₂ alar iliac screws, but the bony structures of the pelvis are developing and growing in children, precise assessment is needed to plan a reasonable screw trajectory and select the appropriate screw length.
Humans ; Male ; Female ; Child ; Adolescent ; Child, Preschool ; Ilium/surgery* ; Retrospective Studies ; Feasibility Studies ; Bone Screws ; Pelvis ; Sacrum/surgery* ; Spinal Fusion/methods*

OBJECTIVE: To develop a novel cognitive screening tool for older adults in China. METHODS: "Game-based Cognitive Assessment-3 Minute Version"(G3) was designed and developed based on WeChat mini-program. And its feasibility was analyzed. RESULTS: G3 mini-program contains three one-minute mini digital games and supports users' self-assessment of cognitive functions with instant access to reports. G3 had a good correlation with Montreal Cognitive Assessment Basic (MoCA-B) with Pearson's r =0.611 (P<0.001). Among natural users aged 50 and older (71 179), the G3 initiation and completion rates were 99.55% and 92.28%, respectively. The average time to complete G3 assessments was (278.5±73.73) seconds. CONCLUSIONS The novel G3 mini-program has good feasibility and usability for older Chinese adults, and can be used for cognitive screening and home self-assessment.
Feasibility Studies ; Neuropsychological Tests ; Cognition ; China

OBJECTIVE: To explore the feasibility of snuff pot arterial pressure measurement for patients undergoing routine elective surgery during anesthesia. METHODS: A prospective randomized controlled trial was conducted. Patients undergoing elective surgery admitted to the Handan Hospital of Traditional Chinese Medicine from June 1, 2020 to June 1, 2022 were enrolled. Patients who needed arterial pressure measurement for hemodynamic monitoring were randomly divided into routine radial artery puncture group and snuff pot artery puncture group with their informed consent. The patients in the routine radial artery puncture group were placed a catheter at the styloid process of the patient's radius to measure pressure. In the snuff pot artery puncture group, the snuff pot artery, that was, the radial fossa on the back of the hand (snuff box), was selected to conduct the snuff pot artery puncture and tube placement for pressure measurement. The indwelling time of arterial puncture catheter, arterial blood pressure, and complications of puncture catheterization of patients in the two groups were observed. Multivariate Logistic regression analysis was used to screen the relevant factors that affect the outcome of arterial catheterization. RESULTS: Finally, a total of 252 patients were enrolled, of which 130 patients received routine radial artery puncture and 122 patients received snuff pot artery puncture. There was no statistically significant difference in general information such as gender, age, body mass index (BMI), and surgical type of patients between the two groups. There was no significant difference in the indwelling time of artery puncture catheter between the routine radial artery puncture group and the snuff pot artery puncture group (minutes: 3.4±0.3 vs. 3.6±0.3, P > 0.05). The systolic blood pressure (SBP) and the diastolic blood pressure (DBP) measured in the snuff pot artery puncture group were significantly higher than those in the conventional radial artery puncture group [SBP (mmHg, 1 mmHg ≈ 0.133 kPa): 162.3±14.3 vs. 156.6±12.5, DBP (mmHg): 85.3±12.6 vs. 82.9±11.3, both P < 0.05]. There was no statistically significant difference in the incidence of complications such as arterial spasm, arterial occlusion, and pseudoaneurysm formation between the two groups. However, the incidence of hematoma formation in the snuff pot artery puncture group was significantly lower than that in the conventional radial artery puncture group (2.5% vs. 4.6%, P < 0.05). Based on the difficulty of arterial puncture, multivariate Logistic regression analysis showed that gender [odds ratio (OR) = 0.643, 95% confidence interval (95%CI) was 0.525-0.967], age (OR = 2.481, 95%CI was 1.442-4.268) and BMI (OR = 0.786, 95%CI was 0.570-0.825) were related factors that affect the outcome of arterial catheterization during anesthesia in patients undergoing elective surgery (all P < 0.05). CONCLUSIONS Catheterization through the snuff pot artery can be a new and feasible alternative to conventional arterial pressure measurement.
Humans ; Arterial Pressure/physiology* ; Feasibility Studies ; Radial Artery/physiology* ; Prospective Studies ; Tobacco, Smokeless ; Catheterization, Peripheral ; Punctures

OBJECTIVE: To evaluate the clinical efficacy of spinal endoscopy in the treatment of severe free lumbar disc herniation and explore the feasibility and application of microscopic drills to expand ventral space. METHODS: Thirty patients with severe free lumbar intervertebral disc herniation treated by spinal endoscopic technique from April 2019 to March 2021 were collected, including 19 males and 11 females;aged from 19 to 76 years with an average of (44.03±16.92) years old. All patients had a single segmental lesion with prolapse of the nucleus pulposus. Among them, there were 3 cases on L_2,3, 3 cases on L_3,4, 15 cases on L_4,5, and 9 cases on L₅S₁. During operation, posterior bone of vertebral body and pedicle notch were removed by a drill under the endoscope to enlarge the ventral space. And the free nucleus pulposus was exposed and completely removed. The intraoperative blood loss, operation time, hospital stay and postoperative neurological complications were recorded, and Japanese Orthopaedic Association (JOA) score, Oswestry Disability Index (ODI) and visual analogue scale (VAS) were compared before operation, 2 days, 3 months and 1 year after operation, and Macnab standard was used to evaluate clinical efficacy. RESULTS: All operations were successful and the free nucleus pulposus was completely removed. Pain in the lower back and legs was significantly relieved on the day after operation. Two patients experienced transient pain and numbness in lower limbs after operation, and no serious nerve injury complications occurred. ODI and VAS at each time point after surgery were significantly lower than those before surgery (P<0.01), and JOA score was significantly higher than before surgery (P<0.01). The excellent and good rates of Macnab were 66.67% (20/30), 83.33% (25/30) and 90.00% (27/30) on 2 days, 3 months and 1 year after operation, respectively. CONCLUSION For severe free lumbar intervertebral disc herniation, using of a drill under endoscope to expand the ventral space can smoothly remove the free nucleus pulposus and avoid nerve damage.
Male ; Female ; Humans ; Young Adult ; Adult ; Middle Aged ; Aged ; Intervertebral Disc Displacement/surgery* ; Feasibility Studies ; Diskectomy, Percutaneous/methods* ; Lumbar Vertebrae/surgery* ; Retrospective Studies ; Endoscopy/methods* ; Treatment Outcome ; Pain/surgery*

OBJECTIVE: We aimed to assess the feasibility and superiority of machine learning (ML) methods to predict the risk of Major Adverse Cardiovascular Events (MACEs) in chest pain patients with NSTE-ACS. METHODS: Enrolled chest pain patients were from two centers, Beijing Anzhen Emergency Chest Pain Center Beijing Bo'ai Hospital, China Rehabilitation Research Center. Five classifiers were used to develop ML models. Accuracy, Precision, Recall, F-Measure and AUC were used to assess the model performance and prediction effect compared with HEART risk scoring system. Ultimately, ML model constructed by Naïve Bayes was employed to predict the occurrence of MACEs. RESULTS: According to learning metrics, ML models constructed by different classifiers were superior over HEART (History, ECG, Age, Risk factors, & Troponin) scoring system when predicting acute myocardial infarction (AMI) and all-cause death. However, according to ROC curves and AUC, ML model constructed by different classifiers performed better than HEART scoring system only in prediction for AMI. Among the five ML algorithms, Linear support vector machine (SVC), Naïve Bayes and Logistic regression classifiers stood out with all Accuracy, Precision, Recall and F-Measure from 0.8 to 1.0 for predicting any event, AMI, revascularization and all-cause death ( vs. HEART ≤ 0.78), with AUC from 0.88 to 0.98 for predicting any event, AMI and revascularization ( vs. HEART ≤ 0.85). ML model developed by Naïve Bayes predicted that suspected acute coronary syndrome (ACS), abnormal electrocardiogram (ECG), elevated hs-cTn I, sex and smoking were risk factors of MACEs. CONCLUSION Compared with HEART risk scoring system, the superiority of ML method was demonstrated when employing Linear SVC classifier, Naïve Bayes and Logistic. ML method could be a promising method to predict MACEs in chest pain patients with NSTE-ACS.
Humans ; Acute Coronary Syndrome/epidemiology* ; Bayes Theorem ; Feasibility Studies ; Risk Assessment/methods* ; Chest Pain/etiology* ; Myocardial Infarction/diagnosis*

OBJECTIVES: To evaluate the feasibility and safety of bipolar-plasmakinetic transurethral enucleation and resection of the prostate (B-TUERP) in day surgery. METHODS: From January 2021 to August 2022, 34 patients with benign prostatic hyperplasia (BPH) underwent B-TUERP in day surgery in the First Affiliated Hospital of Anhui Medical University. Patients completed the screening and anesthesia evaluation before admission and received the standard surgery which implements "anatomical enucleation of the prostate" and "absolute bleeding control" on the same day of admission, and by the same doctor. Bladder irrigation was stopped, catheter was removed and the discharge evaluation was performed on the first day after operation. The baseline data, perioperative conditions, time of recovery, treatment outcomes, hospitalization costs, and postoperative complications were analyzed. RESULTS: All operations were successfully conducted. The average age of the patients was (62.2±7.8) years, average prostate volume was (50.2±29.3) mL. The average operation time was (36.5±19.1) min, the average hemoglobin and blood sodium were decreased by (16.2±7.1) g/L and (2.2±2.0) mmol/L, respectively. The average postoperative length of hospital stay, and total length of hospital stay were (17.7±2.2) and (20.8±2.1) h, respectively, and the average hospitalization cost was (13 558±2320) CNY. All patients were discharged on the day after surgery except for one patient who was transferred to a general ward. Three patients received indwelling catheterization after catheter removal. The 3-month follow-up results showed a substantial improvement in the International Prostate Symptom Score, quality of life score and maximum urinary flow rate (all P<0.01). Three patients experienced temporary urinary incontinence, 1 patient experienced urinary tract infection, 4 patients were diagnosed with urethral stricture and 2 patients experienced bladder neck contracture. No complications above Clavien grade Ⅱ occurred. CONCLUSIONS The preliminary results showed that B-TUERP ambulatory surgery is a safe, feasible, economical and effective treatment for appropriately selected patients with BPH.
Male ; Humans ; Middle Aged ; Aged ; Prostate/surgery* ; Prostatic Hyperplasia/surgery* ; Ambulatory Surgical Procedures ; Quality of Life ; Feasibility Studies ; Retrospective Studies ; Treatment Outcome

OBJECTIVE: To study the feasibility and potential benefits of beam angle optimization (BAO) to automated planning in liver cancer. METHODS: An approach of beam angle sampling is proposed to implement BAO along with the module Auto-planning in treatment planning system (TPS) Pinnacle. An in-house developed plan quality metric (PQM) is taken as the preferred evaluating method during the sampling. The process is driven automatically by in-house made Pinnacle scripts both in sampling and scoring. In addition, dosimetry analysis and physician's opinion are also performed as the supplementary and compared with the result of PQM. RESULTS: It is revealed by the numerical analysis of PQM scores that only 15% patients whose superior trials evaluated by PQM are also the initial trials. Gantry optimization can bring benefit to plan quality along with auto-planning in liver cancer. Similar results are provided by both dose comparison and physician's opinion. CONCLUSIONS It is possible to introduce a full automated approach of beam angle optimization to automated planning process. The advantages of this procedure can be observed both in numerical analysis and physician's opinion.
Humans ; Radiotherapy Planning, Computer-Assisted/methods* ; Feasibility Studies ; Radiometry/methods* ; Liver Neoplasms/radiotherapy* ; Radiotherapy, Intensity-Modulated/methods* ; Radiotherapy Dosage