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

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: To investigate the operation of children's vaccination clinics in Shandong Province, simulate the efficiency of vaccination capacity utilization, and explore the feasibility of carrying out adult vaccination in children's vaccination clinics. Methods: Using the extreme hypothesis method to determine the maximum vaccination capacity of children's vaccination clinics. Based on on-site surveys, population, and vaccination rate data, simulation parameters were determined, and the simulation method was used to simulate the utilization efficiency of vaccination capacity in different scenarios of children's vaccination clinics. Results: There were 2 654 children's vaccination clinics by the end of 2021 in Shandong province. There was (6.93±4.02) staff per vaccination clinic, with an average opening day of (4.16±2.19) days per week. In the scenario of only vaccinating children, the utilization efficiency of vaccination capacity during the non-influenza vaccination season was only 30.74% and 14.07% in urban and rural vaccination clinics, respectively. During the influenza vaccination season, the utilization efficiency of the vaccination capacity of urban vaccination clinics reached 49.26% when the child influenza vaccination rate reached 20%. In the scenario of simultaneous vaccination of children and adults, the utilization efficiency of vaccination capacity during the non-influenza vaccination season was 41.48% and 18.52% in urban and rural vaccination clinics, respectively. During the influenza vaccination season, the utilization efficiency of vaccination capacity in urban vaccination clinics reached 51.47% when the influenza vaccination rate of the entire population reached 3%. The utilization efficiency of vaccination capacity in rural vaccination clinics reached 52.44% when the influenza vaccination rate of the entire population reached 20%. Conclusion: The accessibility of children's vaccination is good in Shandong province, and the utilization efficiency of vaccination capacity can meet the current vaccination needs of children and adults. The vaccination capacity in urban areas needs to be strengthened to meet the growing vaccination needs of children and adults in the future.
Adult ; Child ; Humans ; Feasibility Studies ; Influenza, Human ; Seasons ; Vaccination

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

OBJECTIVE: This study aimed to investigate the feasibility of implementing a manual therapy technique (muscle energy technique, MET) protocol in a hospital pulmonary rehabilitation (PR) program for patients with moderate to severe chronic obstructive pulmonary disease (COPD). Please cite this article as: Baxter DA, Coyle ME, Hill CJ, Worsnop C, Shergis JL. Muscle energy technique for chronic obstructive pulmonary disease: A feasibility study. J Integr Med. 2023; 21(3): 245-253. METHODS: Participants aged 40 years and over, with moderate to severe COPD, were recruited into this 12-week study. The primary outcome measures were feasibility (acceptability of the intervention and attendance/adherence to the trial) and safety (adverse events, AEs). All participants received the MET and PR therapies. Participants and assessors were unblinded. Semi-standardized MET was delivered on 6 occasions (a maximum of once per week) at the hospital directly before a PR session. Participants undertook PR sessions as per the hospital program at a frequency of two days per week for 8 weeks. Participants were contacted 4 weeks after their final MET treatment via a telephone call to assess acceptability of the intervention. RESULTS: Thirty-three participants were enrolled, with a median age of 74 years (range 45-89 years). The median number of MET sessions that participants attended was 5 (range 0-6) out of a possible 6 sessions (83% attendance). At follow-up, participants overwhelmingly enjoyed the MET treatment with some subjectively reporting improved breathing. There were no major AEs related to the intervention, with the majority of AEs classified as expected events related to COPD exacerbations. CONCLUSION It is feasible to implement a manual therapy protocol using MET as an adjunct to PR in a hospital setting. Recruitment rates were satisfactory and there were no AEs related to the MET component of the intervention.
Humans ; Adult ; Middle Aged ; Aged ; Aged, 80 and over ; Feasibility Studies ; Pulmonary Disease, Chronic Obstructive/therapy* ; Muscles ; Quality of Life

BACKGROUND: With the COVID-19 pandemic and sudden transition to online learning, students experience academic difficulties, which are correlated to physical and mental health. The need for implementation of an online wellbeing intervention program for students may lead to better health and improved academic performance. OBJECTIVES: This study aims to evaluate the feasibility and effectiveness of a six-week online educational wellbeing program for University of Santo Tomas College of Rehabilitation Sciences (UST-CRS) students on their physical and mental health. METHOD: This will utilize a quasi-experimental one-group pretest-posttest design, with purposive sampling of at least 40 participants with no physical and/or mental condition. Participants’ eligibility will be screened using the Physical Activity Readiness Questionnaire and Counseling Center Assessment of Psychological Symptoms. Wix platform will be used to assess participants’ well-being, which encompasses psychological and physical activities including physical activity tracking, virtual group exercises, Positive Psychological Intervention, walking, motivational interviewing, mindfulness exercises, Acceptance and Commitment Therapy, and Internet-based cognitive behavioral therapy. The International Physical Activity Questionnaire and World Health Organization-Five WellBeing Index will be used as pre and post-tests. Descriptive statistics will be used to summarize data and inferential statistics for Paired t-tests or Wilcoxon. EXPECTED RESULTS The findings will include the participants’ responses on the feasibility of the physical and mental wellbeing components of the proposed online program. Results are expected to be beneficial to students and university personnel for promoting a conducive learning environment and may be recommended for college-wide online program implementation.
online ; feasibility

Objective: To determine the feasibility of using temporary permanent pacemaker (TPPM) in patients with high-degree atrioventricular block (AVB) after transcatheter aortic valve replacement (TAVR) as bridging strategy to reduce avoidable permanent pacemaker implantation. Methods: This is a prospective observational study. Consecutive patients undergoing TAVR at Beijing Anzhen Hospital and the First Affiliated Hospital of Zhengzhou University from August 2021 to February 2022 were screened. Patients with high-degree AVB and TPPM were included. Patients were followed up for 4 weeks with pacemaker interrogation at every week. The endpoint was the success rate of TPPM removal and free from permanent pacemaker at 1 month after TPPM. The criteria of removing TPPM was no indication of permanent pacing and no pacing signal in 12 lead electrocardiogram (EGG) and 24 hours dynamic EGG, meanwhile the last pacemaker interrogation indicated that ventricular pacing rate was 0. Routinely follow-up ECG was extended to 6 months after removal of TPPM. Results: Ten patients met the inclusion criteria for TPPM, aged (77.0±11.1) years, wirh 7 females. There were 7 patients with third-degree AVB, 1 patient with second-degree AVB, 2 patients with first degree AVB with PR interval>240 ms and LBBB with QRS duration>150 ms. TPPM were applied on the 10 patients for (35±7) days. Among 8 patients with high-degree AVB, 3 recovered to sinus rhythm, and 3 recovered to sinus rhythm with bundle branch block. The other 2 patients with persistent third-degree AVB received permanent pacemaker implantation. For the 2 patients with first-degree AVB and LBBB, PR interval shortened to within 200 ms. TPPM was successfully removed in 8 patients (8/10) at 1 month without permanent pacemaker implantation, of which 2 patients recovered within 24 hours after TAVR and 6 patients recovered 24 hours later after TAVR. No aggravation of conduction block or permanent pacemaker indication were observed in 8 patients during follow-up at 6 months. No procedure-related adverse events occurred in all patients. Conclusion: TPPM is reliable and safe to provide certain buffer time to distinguish whether a permanent pacemaker is necessary in patients with high-degree conduction block after TAVR.
Female ; Humans ; Atrioventricular Block/therapy* ; Feasibility Studies ; Transcatheter Aortic Valve Replacement ; Pacemaker, Artificial ; Bundle-Branch Block

Objective: To investigate the oncologic and surgical safety of the fused fascia method for immediate breast reconstruction with implants. Methods: The clinical data of 343 patients with immediate breast reconstruction with implants in Tianjin Medical University Cancer Hospital from 2014-2017 were retrospectively analyzed to compare the 5-year local recurrence-free survival, 5-year disease-free survival and 5-year overall survival of patients with breast reconstruction by fusion fascia and other methods, and to analyze the complication incidences of implant removal between different implant groups. Results: Of the 343 patients with breast reconstruction, 95 were in the fused fascia group (fascia group) and 248 were in the non-fascia group (25 in the bovine pericardial patch group and 223 in the muscle flap group). At a median follow-up of 49 months, the differences in 5-year local recurrence-free survival (90.1% and 94.9%, respectively), 5-year disease-free survival (89.2% and 87.6%, respectively), and 5-year overall survival (95.2% and 95.1%, respectively) between patients in the fascial and non-fascial groups were not statistically significant (P>0.05). The complication incidence of implant removal was 24.0% (6/25) in the patch group and 2.1% (2/95) and 2.2% (5/223) in the fascia and muscle flap groups, respectively. Conclusion: Immediate breast reconstruction with fused fascial combined with implant is safe and feasible, less invasive than muscle flaps, more economical and with fewer complications than patches.
Humans ; Animals ; Cattle ; Female ; Mastectomy/methods* ; Retrospective Studies ; Breast Implants/adverse effects* ; Feasibility Studies ; Mammaplasty/methods* ; Breast Neoplasms/complications* ; Treatment Outcome ; Postoperative Complications/surgery*