External Pilot Research Articles

Three-outcome designs for external pilot trials with progression criteria

BackgroundWhether or not to progress from a pilot study to a definitive trial is often guided by pre-specified quantitative progression criteria with three possible outcomes. Although the choice of these progression criteria will help to determine the statistical properties of the pilot trial, there is a lack of research examining how they, or the pilot sample size, should be determined.MethodsWe review three-outcome trial designs originally proposed in the phase II oncology setting and extend these to the case of external pilots, proposing a unified framework based on univariate hypothesis tests and the control of frequentist error rates. We apply this framework to an example and compare against a simple two-outcome alternative.ResultsWe find that three-outcome designs can be used in the pilot setting, although they are not generally more efficient than simpler two-outcome alternatives. We show that three-outcome designs can help allow for other sources of information or other stakeholders to feed into progression decisions in the event of a borderline result, but this will come at the cost of a larger pilot sample size than the two-outcome case. We also show that three-outcome designs can be used to allow adjustments to be made to the intervention or trial design before commencing the definitive trial, providing the effect of the adjustment can be accurately predicted at the pilot design stage. An R package, tout, is provided to optimise progression criteria and pilot sample size.ConclusionsThe proposed three-outcome framework provides a way to optimise pilot trial progression criteria and sample size in a way that leads to desired operating characteristics. It can be applied whether or not an adjustment following the pilot trial is anticipated, but will generally lead to larger sample size requirements than simpler two-outcome alternatives.

616. POST-ESOPHAGECTOMY REHABILITATION IS ASSOCIATED WITH EARLY IMPROVEMENTS IN PHYSICAL FITNESS AND SARCOPENIA: PRELIMINARY RESULTS FROM THE FITNESS AFTER OESOPHAGECTOMY (FARO) TRIAL

Abstract Introduction Curative treatment of gastro-esophageal cancer encompasses surgery and peri-operative chemo(radio)therapy. Advancements in oncological treatment and surgical techniques have resulted in incremental prognostic gains with increasing focus on survivorship and optimising quality of life (QoL). Despite enhanced recovery pathways, patients receive no assistance to improve physical functioning and QoL in the post-esophagectomy recovery period. Post-operative rehabilitation has demonstrated improvement in physical fitness and psychosocial wellbeing among other cancer subtypes. The aim of this study was to determine the impact of a patient-directed, home-based rehabilitation programme upon physical functioning in the early recovery phase following an esophagectomy. Methods The Fitness AfteR Oesophagectomy (FARO) study was a prospective, single-centre, parallel-group, open-label, two-arm, pragmatic randomised controlled external pilot trial. Patients were randomised to receive post-operative rehabilitation (alongside routine care- REHAB) or standard clinical care (NO-REHAB) alone in a 1:1 ratio. The rehabilitation intervention encompassed a 12-week home-based programme with weekly step-count targets, completion of resistance exercises and dietary monitoring. Cardiorespiratory fitness was determined by the 6-minute walk test (6MWT) and the functional impact of sarcopenia was assessed by the hand-grip strength (HGS). Outcomes were measured at baseline and 6 weeks post-esophagectomy. Between-group differences were analysed using linear mixed effects models. Results A total of 60 patients were included and randomised to REHAB (n=31) or NO-REHAB (n=29). A total of 29 patients in the REHAB group (93.5%) completed the rehabilitation programme with a 100% adherence rate. At 6 weeks post-esophagectomy, there was statistically significant improvements in the functional impact of sarcopenia as denoted by improvements in HGS in REHAB versus the NO-REHAB cohorts (mean difference= 4.237; 95% c.i 0.80-7.70; p=0.017). Cardiopulmonary fitness, as determined by the 6MWT, was comparable between cohorts with no statistically significant intergroup differences at 6 weeks (mean difference= 62.008; 95% c.i -5.85-129.91; p=0.073). Conclusion Post-operative rehabilitative interventions result in improvements in physical functioning in the early recovery phase following an esophagectomy. Further analysis from the FARO trial will determine if rehabilitation restores and improves QoL and recovery of cardiopulmonary fitness into survivorship.

Evaluating the impact of a year-long external mentorship pilot program in classical hematology

AbstractEffective mentorship is a pivotal factor in shaping the career trajectory of trainees interested in classical hematology (CH), which is of critical importance due to the anticipated decline in the CH workforce. However, there is a lack of mentorship opportunities within CH compared with medical oncology. To address this need, a year-long external mentorship program was implemented through the American Society of Hematology Medical Educators Institute. Thirty-five hematology/oncology fellows interested in CH and 34 academically productive faculty mentors from different institutions across North America were paired in a meticulous process that considered individual interests, experiences, and background. Pairs were expected to meet virtually once a month. Participation in a scholarly project was optional. A mixed-methods sequential explanatory design was used to evaluate the program using mentee and mentor surveys, a mentee interview, and a mentee focus group. Thirty-three mentee-mentor pairs (94.2%) completed the program. Sixty-three percent of mentee respondents worked on a scholarly project with their mentor; several mentees earned publications, grants, and awards. Mentee perception that their assigned mentor was a good match was associated with a perceived positive impact on confidence (P = .0423), career development (P = .0423), and professional identity (P = .0302). Furthermore, 23 mentees (66%) accepted CH faculty positions after fellowship. All mentor respondents believed that this program would increase retention in CH. This mentorship program demonstrates a productive, beneficial way of connecting mentees and mentors from different institutions to improve the careers of CH trainees, with the ultimate goal of increasing retention in CH.

Comparison of Serial Amnioinfusion Strategies for Isolated Early-Onset Fetal Renal Anhydramnios.

The optimal protocol for serial amnioinfusions to maintain amniotic fluid in pregnancies with early-onset fetal renal anhydramnios before 22 weeks is not known. We compared the performance of two different approaches. A secondary analysis was conducted of serial amnioinfusions performed by a single center during the external pilot and feasibility phases of the Renal Anhydramnios Fetal Therapy (RAFT) trial. During the external pilot, higher amnioinfusion volumes were given less frequently; in the feasibility study, smaller volume amnioinfusions were administered more frequently. Procedural details, complications, and obstetric outcomes were compared between the two groups using Pearson's χ2 or Fisher's exact tests for categorical variables and Student's t tests or Wilcoxon rank-sum tests for continuous variables. The adjusted association between procedural details and chorioamniotic separation was obtained through a multivariate repeated measure logistic regression model. Eleven participants underwent 159 amnioinfusions (external pilot: 3 patients, 21 amnioinfusions; feasibility: 8 patients, 138 amnioinfusions). External pilot participants had fewer amnioinfusions (7 vs. 19.5 in the feasibility group, p = 0.04), larger amnioinfusion volume (750 vs. 500 mL, p < 0.01), and longer interval between amnioinfusions (6 [4-7] vs. 4 [3-5] days, p < 0.01). In the external pilot, chorioamniotic separation was more common (28.6% vs. 5.8%, p < 0.01), preterm prelabor rupture of membranes (PPROM) occurred sooner after amnioinfusion initiation (28 ± 21.5 vs. 75.6 ± 24.1 days, p = 0.03), and duration of maintained amniotic fluid between first and last amnioinfusion was shorter (38 ± 17.3 vs. 71 ± 19 days, p = 0.03), compared to the feasibility group. While delivery gestational age was similar (35.1 ± 1.7 vs. 33.8 ± 1.5 weeks, p = 0.21), feasibility participants maintained amniotic fluid longer. Small volume serial amnioinfusions performed more frequently maintain normal amniotic fluid volume longer because of delayed occurrence of PPROM.

Feasibility and acceptability of autism adapted safety plans: an external pilot randomised controlled trial

Autistic people are a high-risk group for self-harm and suicide. There are no evidence-based suicide prevention interventions developed specifically for autistic people. We undertook a pilot feasibility randomised controlled trial of autism adapted safety plans (AASP) to reduce self-harm and suicide for autistic people. This study took place in the United Kingdom and followed a randomised, two-arm, controlled design. Autistic adults (n=53, mean age=39, gender=49% female, 29% not male or female) were recruited via third sector organisations and self-referral between 11.8.21 and 19.10.22. Participants were randomised without stratification to usual care with or without AASP. The AASP was completed by the autistic adults together with someone trained to support them. Research staff who completed follow-up assessments were blind to participant allocation. Primary outcomes were feasibility and acceptability. Participants were assessed at baseline, 1 and 6 months. Primary data were analysed under the intention to treat principle. Study protocol is published. The trial is closed to new participants. This study is registered with the ISRCTN registry, ISRCTN70594445. 53 participants consented, 49 were randomised to either AASP with usual care (n=25) or usual care (n=24). 68% of participants in the AASP arm were satisfied with the AASP and 41% rated it as useable. Feedback on the AASP and research methods were positive with suggested adaptations to some outcome measures. Retention and completion of outcomes measures in both arms was excellent, as was fidelity of delivery of the AASP. Study progression criteria were met, suggesting that the parameters of a future definitive trial of clinical and cost effectiveness of AASP to reduce self-harm and suicide in autistic adults are achievable, with minor recommended adaptions to outcome measures and AASP. Future research should explore the use of AASP in routine clinical practice. This study is funded by the NIHR [Public Health Research Programme (NIHR129196)].

Feasibility and acceptability of autism adapted safety plans: an external pilot randomised controlled trial

Feasibility and acceptability of autism adapted safety plans: an external pilot randomised controlled trial

“Reality is frequently inaccurate” A case study examining the whens and whys of post-live database changes in a UK clinical trials unit *Douglas Adams

IntroductionAccurately estimating the costs of clinical trials is challenging. There is currently no reference class data to allow researchers to understand the potential costs associated with database change management in clinical trials. MethodsWe used a case-based approach, summarising post-live changes in eleven clinical trial databases managed by Sheffield Clinical Trials Research Unit. We reviewed the database specifications for each trial and summarised the number of changes, change type, change category, and timing of changes. We pooled our experiences and made observations in relation to key themes. ResultsMedian total number of changes across the eleven trials was 71 (range 40–155) and median number of changes per study week was 0.48 (range 0.32–1.34). The most common change type was modification (median 39, range 20–90), followed by additions (median 32, range 18–55), then deletions (median 7, range 1–12). In our sample, changes were more common in the first half of the trial's lifespan, regardless of its overall duration. Trials which saw continuous changes seemed more likely to be external pilots or trials in areas where the trial team was either less experienced overall or within the particular therapeutic area. ConclusionsResearchers should plan trials with the expectation that clinical trial databases will require changes within the life of the trial, particularly in the early stages or with a less experienced trial team. More research is required to understand potential differences between clinical trial units and database types.

A pilot randomised controlled trial of acceptance and commitment therapy for medication decision-making and quality of life in women with breast cancer: The ACTION trial.

Non-adherence to adjuvant endocrine therapy (AET) in women with breast cancer is common and associated with medication side-effects and distress. We co-designed an Acceptance and Commitment Therapy intervention (ACTION) to enhance medication decision-making and quality of life (QoL). We undertook a pilot trial of ACTION to inform the feasibility of a phase III trial, and to examine intervention acceptability. This was a multi-site, exploratory, two-arm, individually randomised external pilot trial. Women with early breast cancer prescribed AET were randomised (1:1) to receive usual care (UC) or UC+ACTION. The ACTION intervention comprised a remotely delivered one-to-one ACT session followed by three group sessions delivered by clinical psychologists, alongside a website containing ideas for the self-management of side effects. Of the 480 women screened for eligibility, 260 (54.2%) were approached and 79 (30.4%) randomised. 71 (89.9%) women provided data at 3-month and 70 (88.6%) at 6-month 40 women were randomised to receive UC+ACTION and 32 (80.0%) completed the intervention. Most (75.0%) accessed the website at least once. ACTION was acceptable to participants (Borkovec & Nau Scale: mean=7.8 [SD=2.7] out of 10). Signals of effectiveness in favour of the UC+ACTION arm were observed for medication adherence (Adherence Starts with Knowledge questionnaire-12), QoL (work and social adjustment scale), health-related QoL (functional assessment of cancer therapy[FACT] general and FACT-ES-19/23), distress (generalised anxiety disorder -7, patient health questionnaire-9) and psychological flexibility (valuing questionnaire). The ACTION intervention was acceptable to patients. There were promising signals for effectiveness on primary and secondary outcomes. A phase III randomised controlled trial is feasible. ISRCTN12027752.

Considering Burnout and Well-Being: Emergency Medicine Resident Shift Scheduling Platform and Satisfaction Insights from a Quality Improvement Project.

Few studies explore emergency medicine (EM) residency shift scheduling software as a mechanism to reduce administrative demands and broader resident burnout. A local needs assessment demonstrated a learning curve for chief resident schedulers and several areas for improvement. In an institutional quality improvement project, we utilized an external online cross-sectional convenience sampling pilot survey of United States EM residency programs to collect information on manual versus software-based resident shift scheduling practices and associated scheduler and scheduler-perceived resident satisfaction. Our external survey response rate was 19/253 (8%), with all United States regions (i.e., northeast, southeast, midwest, west, and southwest) represented. Two programs (11%) reported manual scheduling without any software. ShiftAdmin was the most popularly reported scheduling software (53%). Although not statistically significant, manual scheduling had the lowest satisfaction score and programs with ≤30 residents reported the highest levels of satisfaction. Our data suggest that improvements in existing software-based technologies are needed. Artificial intelligence technologies may prove useful for reducing administrative scheduling demands and optimizing resident scheduling satisfaction.

Assessment of Heart Rate Variability and Energy Expenditure Index during Ambulation on Uneven Surface Among Young Adults of Aged 18–30 years

Context: Walking on uneven surfaces is a common daily activity that presents unique challenges to the human body’s energy expenditure and cardiovascular system. This research delves into the unique demands of navigating such surfaces, focusing on two key metrics: energy expenditure index (EEI) and heart rate variability (HRV). Understanding how these physiological parameters are affected during ambulation on irregular terrain is crucial for various fields, including sports science, rehabilitation, and occupational health. Aim: Despite the ubiquity of uneven terrain ambulation in low- and middle-income countries, the physiological responses to such terrain remain understudied. This external pilot study addresses this gap by investigating HRV and EEI during ambulation on various uneven surfaces in healthy young adults. Objectives: The objectives of this study were to evaluate how HRV parameters and EEI respond to ambulation on various uneven surfaces such as roads, grass, sand, and pebbles. Methods and Material: This observational cross-sectional study employed a convenience sample of 35 healthy young adults aged 18–30 years. Participants completed 5-min walks on various surfaces (level, road, grass, sand, and pebbles), whereas HRV and EEI were measured using a polar H10 HR monitor and the elite HRV mobile application and EEI through standard formula. Results: Data were analyzed using descriptive statistics, Shapiro–Wilk tests for normality, and one-way analysis of variance with Bonferroni post hoc tests. No statistically significant differences in HRV or EEI were found between level, sand, pebbles, road, or grass surfaces in healthy young adults (P > 0.05 for all comparisons). Conclusions: While healthy young adults adapted readily to navigating diverse uneven terrain, showing no significant changes in HRV or EEI, research with larger, diverse samples, and longer exposure is needed to confirm clinical implications for populations with lower adaptability or facing more challenging surfaces.

Determining the Effectiveness of Fibrin Sealants in Reducing Complications in Patients Undergoing Lateral Neck Dissection (DEFeND): A Randomised External Pilot Trial.

High-quality randomised controlled trials (RCT) to support the use of Fibrin Sealants (FS) in neck dissection (ND) are lacking. The DEFeND trial assessed critical pilot/feasibility questions and signals from clinical outcomes to inform a future definitive trial. The study design piloted was a blinded surgical RCT. All participants underwent unilateral ND for head and neck cancer. Interventional arm: ND with application of FS. ND alone. Feasibility outcomes included recruitment, effectiveness of blinding, protocol adherence and evaluating administrative processes. Clinical outcomes included surgical complications (primary outcome), drainage volume, time to drain removal, length of hospital stay, pain and the Neck Dissection Impairment Index. Recruitment completed ahead of time. Fifty-three patients were recruited, and 48 were randomised at a rate of 5.3 patients/month. Blinding of patients, research nurses and outcome assessors was effective. Two protocol deviations occurred. Two patients were lost to follow-up. The mean (SD) Comprehensive Complication Index in the interventional arm was 6.5 (12.8), and it was 9.9 (14.2) in the control arm. The median (IQR) time to drain removal (days) was shorter in the interventional arm (2.67 (2.42, 3.58) vs. 3.40 (2.50, 4.27)). However, this did not translate to a clinically significant reduction in median (IQR) length of hospital stay in days (intervention: 3.48 (2.64, 4.54), control: 3.74 (3.11, 4.62)). The proposed trial design was effective, and a definitive surgical trial is feasible. Whilst there was a tendency for FS to improve clinical outcomes, the effect size did not reach clinical or statistical significance. (ISRCTN99181100).

Fitness AfteR Oesophagectomy (FARO): study protocol for an external pilot trial of the impact of rehabilitation on quality of life after surgery for oesophageal cancer

Introduction Curative treatment of gastro-oesophageal cancer encompasses surgery and peri-operative chemo(radio)therapy. Oesophagectomy carries significant morbidity and mortality with an adverse impact upon patients’ quality of life (QoL). Advancements in oncological treatment and surgical techniques have resulted in incremental prognostic gains with increasing focus on survivorship and optimising QoL. Despite enhanced recovery pathways, patients receive no assistance to improve physical functioning and QoL in the recovery period following hospital discharge. Post-operative rehabilitation has demonstrated improvement in physical fitness and psychosocial wellbeing among other cancer subtypes. There is a need to develop rehabilitative interventions that improve and restore patients’ QoL following an oesophagectomy. The aim of the FARO (Fitness AfteR Oesophagectomy) pilot trial is to determine if a pragmatic, patient-directed rehabilitation programme following oesophagectomy improves patients’ QoL. Methods The FARO study is a prospective, single-centre, parallel group, open-label, two-arm pragmatic randomised controlled external pilot trial that will run over 24 months. The trial aims to recruit 60 patients undergoing oesophageal cancer surgery. Patients will be randomized to receive standard clinical care or post-operative rehabilitation (alongside standard clinical care) in a 1:1 ratio. The rehabilitation intervention encompasses a 12-week home-based programme with weekly step-count targets, completion of resistance exercises and dietary monitoring. The primary outcome is patients’ health-related quality of life (assessed by the EORTC QLQ-C30 and OG-25 questionnaires). Secondary outcomes include cardiopulmonary fitness, functional impact of sarcopenia and biochemical nutritional markers. Outcomes are measured at baseline (at discharge from hospital post-oesophagectomy), 6 weeks, 3- and 6 months post-surgery. Discussion This external pilot trial aims to assess if a patient-directed rehabilitation programme following oesophagectomy restores and improves patients’ HR-QOL and recovery of physical functioning. Further, the trial aims to obtain adequate pilot data to plan a future definitive UK-wide trial of perioperative rehabilitation following oesophagectomy. Trial registration number: ISRCTN Registry ISCRTN73024784; Pre-results

Sample size determination for external pilot cluster randomised trials with binary feasibility outcomes: a tutorial

Justifying sample size for a pilot trial is a reporting requirement, but few pilot trials report a clear rationale for their chosen sample size. Unlike full-scale trials, pilot trials should not be designed to test effectiveness, and so, conventional sample size justification approaches do not apply. Rather, pilot trials typically specify a range of primary and secondary feasibility objectives. Often, these objectives relate to estimation of parameters that inform the sample size justification for the full-scale trial, many of which are binary. These binary outcomes are referred to as “feasibility outcomes” and include expected prevalence of the primary trial outcome, primary outcome availability, or recruitment or retention proportions.For pilot cluster trials, sample size calculations depend on the number of clusters, the cluster sizes, the anticipated intra-cluster correlation coefficient for the feasibility outcome and the anticipated proportion for that outcome. Of key importance is the intra-cluster correlation coefficient for the feasibility outcome. It has been suggested that correlations for feasibility outcomes are larger than for clinical outcomes measuring effectiveness. Yet, there is a dearth of information on realised values for these correlations.In this tutorial, we demonstrate how to justify sample size in external pilot cluster trials where the objective is to estimate a binary feasibility outcome. We provide sample size calculation formulae for a variety of scenarios, make available an R Shiny app for implementation, and compile a report of intra-cluster correlations for feasibility outcomes from a convenience sample. We demonstrate that unless correlations are very low, external pilot cluster trials can be made more efficient by including more clusters and fewer observations per cluster.

Intervention to reduce sedentary behaviour and improve outcomes after stroke (Get Set Go): a study protocol for the process evaluation of a pilot cluster randomised controlled trial (RECREATE)

IntroductionStroke survivors spend long periods of time engaging in sedentary behaviour (SB) even when their functional recovery is good. In the RECREATE programme, an intervention aimed at reducing SB (‘Get...

ENSURING SPEED STABILITY OF THE UNMANNED AERIAL VEHICLE IN DIF-FERENT FLIGHT MODES

The publication deals with the issue of ensuring the stability of an unmanned aerial vehicle flight by speed. An analysis of the physical essence of the process of ensuring the unmanned aerial vehicle stability by speed is presented. Attention is paid to the flight modes in which the operator (external pilot) may encounter difficulties in the practical piloting of the unmanned aerial vehicle. The possible causes of abnormal situations when flying the unmanned aerial vehicle at speeds close to the borderline low are analyzed. Possible actions of the operator (external pilot) to return the unmanned aerial vehicle to the operating speed range from the area of instability are considered. The article shows the features of stability and controllability of an unmanned aerial vehicle in a route flight mode. Attention is paid to the complexity of piloting and safety of flight in the second modes. The article demonstrates the method of determining the boundary between the first and second flight modes. The features of unmanned aerial vehicle management and ensuring stability in the first and second modes are shown. The issue of dynamic stability of the unmanned aerial vehicle is investigated. Numerical modeling of the longitudinal movement of the unmanned aerial vehicle in free, uncontrolled flight was carried out, trajectories for the unmanned aerial vehicle of the selected configuration with a change in speed and angle of inclination of the trajectory in time were obtained. Graphs of movement trajectories with changes in speed and height over time were constructed, graphs of transient processes were constructed for cases of stable and unstable flight modes. An analysis of the external factors that most affect the flight parameters in various conditions of unmanned aerial vehicle use was carried out.

Physiotherapy Rehabilitation Post Patellar Dislocation (PRePPeD)—protocol for an external pilot randomised controlled trial and qualitative study comparing supervised versus self-managed rehabilitation for people after acute patellar dislocation

BackgroundPatellar dislocations mainly affect adolescents and young adults. After this injury, patients are usually referred to physiotherapy for exercise-based rehabilitation. Currently, limited high-quality evidence exists to guide rehabilitation practice and treatment outcomes vary. A full-scale trial comparing different rehabilitation approaches would provide high-quality evidence to inform rehabilitation practice. Whether this full-scale trial is feasible is uncertain: the only previous trial that compared exercise-based programmes in this patient population had high loss to follow-up. This study aims to assess the feasibility of conducting a future full-scale trial comparing the clinical and cost-effectiveness of two different rehabilitation approaches for people with an acute patellar dislocation.MethodsTwo-arm parallel external pilot randomised controlled trial and qualitative study. We aim to recruit at least 50 participants aged ≥ 14 years with an acute first-time or recurrent patellar dislocation from at least three English National Health Service hospitals. Participants will be randomised 1:1 to supervised rehabilitation (four to six, one-to-one, physiotherapy sessions of advice and prescription of tailored progressive home exercise over a maximum of 6 months) or self-managed rehabilitation (one physiotherapy session of self-management advice, exercise, and provision of self-management materials). Pilot objectives are (1) willingness to be randomised, (2) recruitment rate, (3) retention, (4) intervention adherence, and (5) intervention and follow-up method acceptability to participants assessed through one-to-one semi-structured interviews (maximum 20 participants). Follow-up data will be collected 3, 6, and 9 months after randomisation. Quantitative pilot and clinical outcomes will be numerically summarised, with 95% confidence intervals generated for the pilot outcomes using Wilson’s and exact Poisson methods as appropriate.DiscussionThis study will assess the feasibility of conducting a full-scale trial comparing supervised versus self-managed rehabilitation for people after acute first-time or recurrent patellar dislocation. This full-scale trial’s results would provide high-quality evidence to guide rehabilitation provision for patients with this injury.Trial registrationISRCTN registry ISRCTN14235231. Registered on 09 August 2022.

RECREATE: a study protocol for a multicentre pilot cluster randomised controlled trial (cRCT) in UK stroke services evaluating an intervention to reduce sedentary behaviour in stroke survivors (Get Set Go) with embedded process and economic evaluations

IntroductionSedentary behaviour (sitting or lying during waking hours without being otherwise active) is strongly associated with adverse health outcomes, including all-cause, cancer and cardiovascular mortality in adults. Stroke survivors are...

Evolving the Cybersecurity of Clinical Photography in Plastic Surgery.

Point-of-care photography and photo sharing optimize patient outcomes and facilitate remote consultation imperative for resident surgeons. This literature review and external pilot survey study highlight the risks associated with current practices concerning patient privacy and biometric security. In a survey of 30 plastic surgeon residents and attendings, we found that the majority took photos of patients with their iPhones and shared them with colleagues via Apple iMessage. These findings corroborate previous reports and highlight a lack of physician user acceptance of secure photo-sharing platforms. Finally, we frame a successful example from the literature in the context of a postulated framework for institutional change. Prioritizing the privacy and safety of patients requires a strategic approach that preserves the ease and frequency of use of current practices.

Engineering and navigating calculation the flight of unmanned aircrafts of tactical class

The regulatory documents of the Ministry of Defense of Ukraine provide for navigational training of the crews of unmanned aircraft complexes and establish the necessity of having a navigational plan and an engineering-navigator flight calculation at the workplace of an external UAV pilot. The article notes that today there are no normative documents that would establish the content and scope of engineering and navigational calculations and methods of their implementation for unmanned aircraft complexes of tactical classes. The article as a whole is devoted to the consideration of issues of methodical support of navigator training of crews of unmanned aerial systems of the tactical class with an electric power plant. It is indicated that, based on the tactical and technical capabilities of UAVs of tactical classes, the nature of the tasks performed by them and the typical educational level of their external pilots, the creation of the most simplified methodology for performing basic engineering and navigational calculations of UAV flights is required. The mathematical complexity of such a method should not go beyond general secondary education. When performing navigational calculations of aircraft flights, the main difficulty is created by the problem of taking into account the influence of the wind. Simple algorithms for calculating the correction to the wind drift course, road speed and flight duration on straight sections of the route and sections of U-turns in the presence of wind are proposed. Algorithms for calculating the total need for energy resources for a flight along a given route and for separate sections of the route, including additional energy resource needs for sections of altitude gain, are proposed. Recommendations for evaluating the energy capacity of the battery available for flight performance are given. An algorithm for calculating the critical reserve of energy resources, which is necessary for the possibility of returning the UAV from the farthest point of the route under meteorological conditions for the scheduled flight time, is proposed. Options for full and abbreviated engineering and navigational calculations are offered.

Effect of quadriceps training at different levels of blood flow restriction on quadriceps strength and thickness in the mid-term postoperative period after anterior cruciate ligament reconstruction: a randomized controlled external pilot study

BackgroundMore than 2 million anterior cruciate ligament (ACL) injuries occur worldwide each year. Most surgeons suggest that athletes and active persons with significant knee functional demands, including cutting motions, require and should be offered ligament reconstruction surgery. Despite concentrated rehabilitation efforts, deficits in quadriceps size and strength can persist for years after surgery. Blood flow restriction (BFR) training can help overcome disuse muscular atrophy in the mid-term postoperative period after anterior cruciate ligament reconstruction (ACLR) surgery. The purpose of this study was to evaluate the effects of quadriceps training with different levels of blood flow restriction on quadriceps strength and thickness of participants after ACLR.MethodsIn this study, 30 post-ACL reconstruction participants were randomly divided into three groups (control, 40% Arterial Occlusion Pressure [AOP] and 80% AOP groups). All patients were subjected to different levels of BFR, combined with conventional quadriceps rehabilitation, for 8 weeks. Assessments included scaled maximal isokinetic knee extension strength at 60°/s and 180°/s, the sum of the thickness of the affected femoris rectus and vastus intermedius, Y-balance test performance, and International Knee Documentation Committee questionnaire responses before and after the intervention.ResultsIn total, 23 participants completed the entire study. The 80% AOP compression group showed an increase in quadriceps femoris muscle strength and muscle thickness (p < 0.01). As compared with the control group, outcome indicators in the 40% AOP and 80% AOP group were improved (p < 0.05). After 8 weeks of experimental BFR intervention, the results were better for the 80% AOP compression group than for the 40% AOP compression group in quadriceps peak torque to body weight at 60°/s and 180°/s angular velocity, as well as the sum of the thickness of the rectus femoris and vastus intermedius.ConclusionThe combination of BFR and low-intensity quadriceps femoris training can effectively improve the muscle strength and thickness of knee extensors in participants with ACLR and help reduce the difference between the healthy and surgical sides of the knee joint while improving knee-joint function. Choosing quadriceps training with 80% AOP compression intensity could provide the most benefits. Meanwhile, BFR can accelerate the rehabilitation process of patients and allow early entry into the next rehabilitation cycle.RegistrationTrial registration Chinese Clinical Trial Registry, registration number ChiCTR2100050011, date of registration: 15/08/2021.