Search

Background Although Alzheimer’s disease affects around 800,000 people in the UK and costs almost £23 billion per year, currently licenced treatments only offer modest benefit at best. Seizures, which are more common in patients with Alzheimer’s disease than age matched controls, may contribute to the loss of nerve cells and abnormal brain discharges can disrupt cognition. This aberrant electrical activity may therefore present potentially important drug targets. The anti-seizure medication levetiracetam can reduce abnormal cortical discharges and reverse memory deficits in a mouse model of Alzheimer’s disease. Levetiracetam has also been shown to improve memory difficulties in patients with mild cognitive impairment, a precursor to Alzheimer’s disease. Clinical use of levetiracetam is well-established in treatment of epilepsy and extensive safety data are available. Levetiracetam thus has the potential to provide safe and efficacious treatment to help with memory difficulties in Alzheimer’s disease. Methods The proposed project is a proof of concept study to test whether levetiracetam can help cognitive function in people with dementia. We plan to recruit thirty patients with mild to moderate Alzheimer’s disease with no history of previous seizures or other significant co-morbidity. Participants will be allocated to a double-blind placebo-controlled crossover trial that tests levetiracetam against placebo. Standardised scales to assess cognition and a computer-based touchscreen test that we have developed to better detect subtle improvements in hippocampal function will be used to measure changes in memory. All participants will have an electroencephalogram (EEG) at baseline. The primary outcome measure is a change in the computer-based touchscreen cognitive task while secondary outcomes include the effect of levetiracetam on mood, quality of life and modelling of the EEG, including time series measures and feature-based analysis to see whether the effect of levetiracetam can be predicted. The effect of levetiracetam and placebo will be compared within a given patient using the paired t-test and the analysis of covariance adjusting for baseline values. Discussion This is the first study to evaluate if an anti-seizure medication can offer meaningful benefit to patients with Alzheimer’s disease. If this study demonstrates at least stabilisation of memory function and/or good tolerability, the next step will be to rapidly progress to a larger study to establish whether levetiracetam may be a useful and cost-effective treatment for patients with Alzheimer’s disease. Trial registration ClinicalTrials.govNCT03489044. Registered on April 5, 2018.

Background Practitioners frequently use informed consent forms to support the physician-patient communication and the informed consent process. Informed consent for surgery often focuses on risk centered information due to high liability risks for treatment errors. This may affect patients’ anxiety of adverse events and the nocebo effect. This study focuses on the optimization of pre-surgical information on risks and complications, and at the same time reconciles these information with legal requirements. Methods The development, piloting, and evaluation of evidence-based informed consent forms for total knee arthroplasty (TKA) and related anesthesia procedures will follow the UK MRC Framework for developing and evaluating complex interventions. Conducting different sub-studies, we will (I) qualitatively explore the information acquisition and decision-making processes, (II) develop and pilot test evidence-based informed consent forms on the example of TKA and related anesthesia procedures, (III) conduct a monocentric interrupted time series (ITS) pilot study to evaluate the effects of evidence-based informed consent forms in comparison with standard consent forms, and (IV) perform a process evaluation to identify barriers and facilitators to the implementation of the intervention and to analyze mechanisms of impact. Discussion The evidence-based and understandable presentation of risks in informed consent forms aims at avoiding distorted risk depiction and strengthening the patients’ competencies to correctly assess the risks of undergoing surgery. This might reduce negative expectations and anxiety of adverse events, which in turn might reduce the nocebo effect. At the same time, the practitioners’ acceptance of evidence-based informed consent forms meeting legal requirements could be increased. Trial registration ClinicalTrials.gov, NCT04669483. Registered 15 December 2020. German Clinical Trials Registry, DRKS00022571. Registered 15 December 2020

International audience; AimsDilated cardiomyopathy (DCM) is a complex disease where genetics interplay with extrinsic factors. This study aims to compare the phenotype, management, and outcome of familial DCM (FDCM) and non‐familial (sporadic) DCM (SDCM) across Europe.Methods and resultsPatients with DCM that were enrolled in the prospective ESC EORP Cardiomyopathy & Myocarditis Registry were included. Baseline characteristics, genetic testing, genetic yield, and outcome were analysed comparing FDCM and SDCM; 1260 adult patients were studied (238 FDCM, 707 SDCM, and 315 not disclosed). Patients with FDCM were younger (P < 0.01), had less severe disease phenotype at presentation (P < 0.02), more favourable baseline cardiovascular risk profiles (P ≤ 0.007), and less medication use (P ≤ 0.042). Outcome at 1 year was similar and predicted by NYHA class (HR 0.45; 95% CI [0.25–0.81]) and LVEF per % decrease (HR 1.05; 95% CI [1.02–1.08]. Throughout Europe, patients with FDCM received more genetic testing (47% vs. 8%, P < 0.01) and had higher genetic yield (55% vs. 22%, P < 0.01).ConclusionsWe observed that FDCM and SDCM have significant differences at baseline but similar short‐term prognosis. Whether modification of associated cardiovascular risk factors provide opportunities for treatment remains to be investigated. Our results also show a prevalent role of genetics in FDCM and a non‐marginal yield in SDCM although genetic testing is largely neglected in SDCM. Limited genetic testing and heterogeneity in panels provides a scaffold for improvement of guideline adherence.

Background Corticosteroids (CS) have been used extensively to induce remission in Crohn’s disease (CD); however, they are associated with severe side effects. We hypothesized that the administration of an exclusive enteral nutrition (EEN) formula to CS would lead to increased CD remission rates and to decreased CS-related adverse events. We proposed to undertake a pilot study comparing EEN and CS therapy to CS alone to assess decrease symptoms and inflammatory markers over 6 weeks. Aim The overall aim was to assess study feasibility based on recruitment rates and acceptability of treatment in arms involving EEN Methods The pilot study intended to recruit 100 adult patients with active CD who had been prescribed CS to induce remission as part of their care. The patients were randomized to one of three arms: (i) standard-dose CS; (ii) standard-dose CS plus EEN (Modulen 1.5 kcal); or (iii) short-course CS plus EEN. Results A total of 2009 CD patients attending gastroenterology clinics were screened from October 2018 to November 2019. Prednisone was prescribed to only 6.8% (27/399) of patients with active CD attending outpatient clinics. Of the remaining 372 patients with active CD, 34.8% (139/399) started or escalated immunosuppressant or biologics, 49.6% (198/399) underwent further investigation and 8.8% (35/399) were offered an alternative treatment (e.g., antibiotics, surgery or investigational agents in clinical trials). Only three patients were enrolled in the study (recruitment rate 11%; 3/27), and the study was terminated for poor recruitment. Conclusion The apparent decline in use of CS for treatment of CD has implications for CS use as an entry criterion for clinical trials.

Background Pilot trials often use quantitative data such as recruitment rate and retention rate to inform the design and feasibility of a larger trial. However, qualitative data such as patient, healthcare provider, and research staff perceptions of an intervention may also provide insights for a larger trial. Methods As part of a larger study investigating the reporting of progression criteria in pilot studies, we sought to determine how often pilot studies planned to use qualitative data to inform the design and feasibility of a larger trial and the factors associated with plans to use qualitative data. We searched for protocols of pilot studies of randomized trials in PubMed between 2013 and 2017. Results We included 227 articles. Only 92 (40.5%; 95% confidence interval [CI] 34.1–47.2) reported plans to collect qualitative data. The factors associated with collecting qualitative data were large studies (defined as sample size ≥ 60; adjusted odds ratio [aOR] 2.77; 95% CI 1.47–5.23; p = 0.002) and studies from Europe (aOR 3.86; 95% CI 1.68–8.88; p = 0.001) compared to North America and the rest of the world. Pilot trials with pharmacological interventions were less likely to plan to collect qualitative data (aOR 0.20; 95% CI 0.07–0.58; p = 0.003). Conclusions Qualitative data is not used enough in pilot trials. Large pilot trials, pilot trials from Europe, and pilot trials of non-pharmacological interventions are more likely to plan for qualitative data.

Pilot fatigue is a great hazard to aviation safety. In recent years, long-distance fights have been increasing and flight hours have been increasing, which has made fatigue issues important. International organizations in the aviation sectors (ICAO, FAA, IATA etc.) recommend management of fatigue within the SMS (Safety Management System) framework. A scientific and systematic approach to measuring fatigue is required as a prerequisite to preparing safety management measures for pilot’s fatigue. Therefore, in this study, I would like to consider recent trends and implications for fatigue measurement. First, I aimed to consider recent the accident cases related to fatigue. Second, I also considered how to measure the pilot’s fatigue. Finally, the direction of the countermeasures against fatigue through fatigue measurement was developed and suggested.

Background Surgical bleeding is associated with postoperative cardiovascular complications. The efficacy and safety of tranexamic acid (TXA) in noncardiac surgery are still uncertain. Statins may prevent perioperative cardiovascular complications. We conducted a pilot to assess the feasibility of a perioperative trial of TXA and rosuvastatin. Methods Using a factorial design, we randomized patients at cardiovascular risk undergoing noncardiac surgery to intravenous TXA (1 g at the start and end of surgery) or placebo, and oral rosuvastatin (40 mg before and 20 mg daily for 30 days after surgery) or placebo. Feasibility outcomes included recruitment rates, follow-up, and compliance to interventions. Clinical outcomes were secondarily explored. Results After 3 months, we changed the design to a partial factorial due to the difficult recruitment of statin-naive patients. Over 6 months, 100 patients were randomized in the TXA trial (49 TXA, 51 placebo), 34 in the rosuvastatin trial (18 rosuvastatin, 16 placebo). Ninety-two percent (95% CI 80–98) of TXA and 86% (95% CI 74–94) of TXA-placebo patients received the 2 study doses. Thirty-three percent (95% CI 13–59) of rosuvastatin patients and 37% (95% CI 15–65) of rosuvastatin-placebo patients discontinued the study drug. A major cardiovascular complication occurred at 30 days in 1 TXA and 6 TXA-placebo patients, and 1 rosuvastatin and no rosuvastatin-placebo patients. Conclusions Our pilot study supports the feasibility of a perioperative TXA trial in noncardiac surgery. Feasibility of a perioperative rosuvastatin trial is uncertain because of a high prevalence of statin use in the target population and concerns about compliance. Trial registration ClinicalTrials.govNCT02546648.

Background A thoracolumbar fracture is the most common fracture of the spinal column. Where the fracture is not obviously stable or unstable, the optimal management is uncertain. There are variations between surgeons, treating centres and within the evidence base as to whether surgical or non-surgical approaches should be used. In addition, the boundaries of this zone of uncertainty for stability are unclear. This study has been designed in response to an NIHR HTA commissioning brief to assess the feasibility of undertaking a large-scale trial to evaluate the effectiveness of surgical and non-surgical treatments for thoracolumbar fractures without neurological deficit. Methods Assessment of feasibility will be addressed through three elements: a randomised external feasibility study, a national survey of surgeons and a qualitative study. The external feasibility study is a pragmatic, parallel-group, randomised controlled trial comparing surgical fixation (intervention) versus non-surgical management (control). Recruitment will take place in three secondary care centres in the UK. The primary outcome is recruitment rate, defined as the proportion of eligible participants who are randomised. Further outcomes related to recruitment, randomisation, drop-out, cross-over, loss to follow-up, completeness of outcome data, study processes and details of the interventions delivered will be collected. The survey of surgeons and qualitative study of clinicians, recruiting staff and patients will enhance the feasibility study, enabling a broad overview of current practice in the field in addition to perceived facilitators and barriers to running a full-scale trial. Discussion PRESTO is a feasibility study which aims to inform methodology for a definitive trial comparing surgical fixation with non-surgical management for patients with stable thoracolumbar fractures. Trial registration The trial is registered with the International Standard Randomised Controlled Trial Register (ISRCTN12094890). Date of registration was 22/02/2018 (http://www.isrctn.com/ISRCTN12094890).

BACKGROUND Colorectal cancer (CRC) could seriously threaten the physical and mental health of pilots. Shall they end their flying after treatment of CRC? With this study, we investigated the possibility of a gradual medical waiver for such pilots to fly aircrafts again after treatment of CRC. CASE SUMMARY We analyzed the medical waiver and clinical data of 3 pilots with CRC, who had accepted the treatment at the Department of General Surgery, Air Force Medical Center (formerly, Air Force General Hospital) between 2013 and 2018. All 3 cases underwent a series of comprehensive treatment courses, including radical resection of CRC, sequential radiotherapy, and chemotherapy. The follow-up results were satisfactory. After passing through the high-risk period of recurrence and metastasis of CRC, they all were given a medical waiver for flying again. Medical observation showed that their flying operations were safe. CONCLUSION The CRC treatment shall follow the guidelines for diagnosis and treatment and should simultaneously protect the combating capabilities of pilots as much as possible. It is safe for pilots with CRC, who are continuously monitored under medical observation after passing through the high-risk period of recurrence and metastasis, to undertake military flight missions again.

Objective The Rotterdam Healthy Aging Score (HAS) is a validated multidimensional index constructed from five health domains. We describe the HAS distribution in a cohort of HIV-positive adults and correlate it with health outcomes. Design A cross-sectional pilot study of 101 adults aged at least 40 years, on suppressive antiretroviral therapy attending a tertiary HIV clinic in Toronto, Canada. Methods Participants completed questionnaires to calculate their HAS (range 0-14). Demographics, HAS and sub-scores were compared by age and sex. The HAS was compared with results of the Fried Frailty Score, Short Performance Physical Battery score (SPPB) and measures of health utilization. Kruskal--Wallis Rank-Sum and Fisher's exact tests were used for all comparisons. Results Median (IQR) age was 56 (50--62), 81 (80%) men and 50 (50%) born in Canada. Median (IQR) CD4 cell count was 574 (417--794) cells/μl. Median (IQR) HAS was 12 (10--13) with 39 (39%) achieving a score more than 12 (considered healthy aging). Younger participants experienced more depression, whereas women had greater pain. The HAS score correlated with the Fried Frailty Score (P = 0.008) and trended with the SPPB Score (P = 0.077). Those with the poorest HAS scores were more likely to have been hospitalized in the preceding 6 months (P = 0.034). Conclusion The HAS ranged from 5 to 14 in this cohort of older HIV adults with 39% attaining scores in the 'healthy' range. The HAS correlated with measures of physical performance and health utilization. Further validation of an objective outcome in HIV-positive patients will facilitate evaluation of interventional studies to improve healthy aging.

Funder: Sue and Bob O'Donnell, Summary: Biases introduced in early���stage studies can lead to inflated early discoveries. The risk of generalizability biases (RGBs) identifies key features of feasibility studies that, when present, lead to reduced impact in a larger trial. This meta���study examined the influence of RGBs in adult obesity interventions. Behavioral interventions with a published feasibility study and a larger scale trial of the same intervention (e.g., pairs) were identified. Each pair was coded for the presence of RGBs. Quantitative outcomes were extracted. Multilevel meta���regression models were used to examine the impact of RGBs on the difference in the effect size (ES, standardized mean difference) from pilot to larger scale trial. A total of 114 pairs, representing 230 studies, were identified. Overall, 75% of the pairs had at least one RGB present. The four most prevalent RGBs were duration (33%), delivery agent (30%), implementation support (23%), and target audience (22%) bias. The largest reductions in the ES were observed in pairs where an RGB was present in the pilot and removed in the larger scale trial (average reduction ES ���0.41, range ���1.06 to 0.01), compared with pairs without an RGB (average reduction ES ���0.15, range ���0.18 to ���0.14). Eliminating RGBs during early���stage testing may result in improved evidence.

Background Lateral patellar dislocations mainly affect active teenagers and young adults. To help people recover, non-surgical exercise-based treatment is often recommended but the optimal exercise-based treatment is unknown. Currently, treatment outcomes after this injury are variable. Common problems include recurrent dislocation, reduced activity levels, and later surgery. A programme of intense leg resistance exercises, and dynamic exercises related to participants’ activity-related goals, has rationale, but has not been previously reported. In line with the Medical Research Council guidance, this study aimed to assess the acceptability of a novel evidence-based exercise programme for adults after acute lateral patellar dislocation and the feasibility of future research evaluating this treatment. Methods A single-group prospective study was conducted at the John Radcliffe Hospital, Oxford, UK. Participants were 16 years or older with an acute first-time or recurrent lateral patellar dislocation. Participants received up to six face-to-face, one-to-one, physiotherapy sessions, over a maximum of 3 months, and performed intensive home exercises independently at least three times per week. Strategies to increase exercise adherence were used. Primary objectives were to determine the number of eligible patients, the recruitment rate (proportion of eligible patients that provided written informed consent), participant adherence to scheduled physiotherapy sessions and self-reported adherence to prescribed exercise, and intervention acceptability to participants measured by attrition and a study-specific questionnaire. Data were analysed using descriptive statistics. Results Fifteen of 22 (68%) patients with a lateral patellar dislocation were eligible. All eligible (100%) were recruited. Two of 15 (13%) participants provided no outcome data, 2/15 (13%) provided partial outcome data, and 11/15 (73%) provided all outcome data. Questionnaire responses demonstrated high intervention acceptability to participants. Participants attended 56/66 (85%) physiotherapy sessions and 10/11 (91%) participants reported they ‘always’ or ‘often’ completed the prescribed exercise. One participant redislocated their patella; another experienced knee pain or swelling lasting more than one week after home exercise on three occasions. Conclusion The intervention appeared acceptable to adults after acute lateral patellar dislocation, and a future randomised pilot trial is feasible. This future pilot trial should estimate attrition with increased precision over a longer duration and assess participants’ willingness to be randomised to different treatments across multiple centres. Trial registration ClinicalTrials.govNCT03798483, registered on January 10, 2019

Background Survivors of critical illness experience long-term functional challenges, which are complex, heterogeneous, and multifactorial in nature. Although the importance of rehabilitation interventions after intensive care unit (ICU) discharge is universally recognized, evidence on feasibility and effectiveness of home-based rehabilitation programs is scarce and ambiguous. This study investigates the feasibility of an interdisciplinary rehabilitation program designed for patients with Post-Intensive Care Syndrome (PICS) who are discharged home. Methods A mixed method, non-randomized, prospective pilot feasibility study was performed with a 6-month follow-up, comparing the intervention (REACH) with usual care. REACH was provided by trained professionals and included a patient-centered, interdisciplinary approach starting directly after hospital discharge. Primary outcomes were patient safety, satisfaction, adherence, referral need and health care usage. Secondary outcomes, measured at 3 timepoints, were functional exercise capacity, self-perceived health status, health-related quality of life (HRQoL), return to work and psychotrauma. Risk of undernutrition was assessed at baseline. Results 43 patients with a median mechanical ventilation duration of 8 (IQR:10) days, were included in the study and 79.1% completed 6-month follow-up. 19 patients received the intervention, 23 received usual care. Groups were similar for gender distribution and ICU length of stay. No adverse events occurred. REACH participants showed higher satisfaction with treatment and reported more allied health professional visits, while the usual care group reported more visits to medical specialists. Qualitative analysis identified positive experiences among REACH-professionals related to providing state-of-the-art interventions and sharing knowledge and expertise within an interprofessional network. Similar recovery was seen between groups on all secondary outcomes, but neither group reached reference values for HRQoL at 6 months. Larger return to work rates were seen in the REACH group. Prevalence of undernutrition at hospital discharge was high in both groups (> 80%), warranting the need for careful tuning of physical therapy and nutritional interventions. Conclusions This study shows that providing early, home-based rehabilitation interventions for patients with PICS-related symptoms is feasible and perceived positively by patients and professionals. When provided in an interdisciplinary collaborative network state of the art, person-centered interventions can be tailored to individual needs potentially increasing patient satisfaction, adherence, and efficacy. Registered in the Dutch Trial register: NL7792: https://www.trialregister.nl/trial/7792, registered 7-06-2019.

Background: Research has consistently demonstrated that preventive cardiology programs have limited success, and healthy practices among high-risk individuals remain suboptimal. Furthermore, there are no current programmes in Malta that offer support to first-degree relatives of patients with premature coronary heart disease. This internal pilot study will determine the feasibility, acceptability, and potential effectiveness of a preventative intervention., Methods/design: We are conducting a 12-month single-centre, two-armed group randomised controlled trial (RCT), recruiting a sample of 100 asymptomatic first-degree relatives of patients with premature coronary heart disease (CHD). The study seeks to test an evidence-based intervention to reduce modifiable risk and determine its feasibility and acceptability. The Intervention will be delivered at an outpatient office based in a large acute academic hospital. It will comprise risk communication using an online risk calculator, a counselling style adapted from motivational interviewing, and 12 weekly telephone goal reinforcement calls (3 months). Control subjects will receive verbal lifestyle advice only. Feasibility will be assessed through recruitment and retention. Qualitative evaluation interviews will be conducted with a subsample of 24 purposefully selected participants at 12 months. Assessment for risk factor changes will be measured at pre-intervention and 6 and 12 months. Associations between variables will also be assessed descriptively, Discussion: Preventive cardiology guidelines highlighted the importance of lifestyle interventions, and lifestyle intervention adherence was proven to reduce atherosclerotic cardiovascular disease (ASCVD) risk, regardless of the individual's genetic risk. Preventive cardiology programmes may fail to adequately support persons in modifying risky behaviours, and research demonstrates that healthy practices among high-risk individuals can remain suboptimal. Siblings and offspring of patients with premature CHD are at increased risk of ASCVD. Despite this, there is no process in place for routine screening and support to modify risk. It is hypothesised that participants assigned to the intervention arm will show more cardio-protective lifestyle-related improvement from the baseline than those in the control group. To date, this is the first trial being conducted amongst Maltese first-degree relatives. This study addresses the needed research, and the results will inform a definitive trial. The funding institution is the University of Malta., peer-reviewed

Objective Ketamine has been shown to decrease sedative requirements in intensive care unit (ICU). Randomized trials are limited on patient-centered outcomes. We designed this pilot trial to evaluate the feasibility of a large randomized controlled trial (RCT) testing the effect of ketamine as an adjunct analgosedative compared with standard of care alone as a control group (CG) in critically ill patients with mechanical ventilation (MV). We also provided preliminary evidence on clinically relevant outcomes to plan a larger trial. Material and methods Pilot, active-controlled, open-label RCT was conducted at medical, surgical, and transplant ICUs at a large tertiary and quaternary care medical institution (King Faisal Specialist Hospital and Research Center, Saudi Arabia). The study included adult patients who were intubated within 24 h, expected to require MV for the next calendar day, and had institutional pain and sedation protocol initiated. Patients were randomized in a 1:1 ratio to adjunct ketamine infusion 1–2 μg/kg/min for 48 h or CG alone. Results Of 437 patients screened from September 2019 through November 2020, 83 (18.9%) patients were included (43 in CG and 40 in ketamine) and 352 (80.5%) were excluded. Average enrollment rate was 3–4 patients/month. Consent and protocol adherence rates were adequate (89.24% and 76%, respectively). Demographics were balanced between groups. Median MV duration was 7 (interquartile range [IQR] 3–9.25 days) in ketamine and 5 (IQR 2–8 days) in CG. Median VFDs was 19 (IQR 0–24.75 days) in ketamine and 19 (IQR 0–24 days) in the CG (p = 0.70). More patients attained goal Richmond Agitation–Sedation Scale at 24 and 48 h in ketamine (67.5% and 73.5%, respectively) compared with CG (52.4% and 66.7%, respectively). Sedatives and vasopressors cumulative use, and hemodynamic changes were similar. ICU length-of-stay was 12.5 (IQR 6–21.2 days) in ketamine, compared with 12 (IQR 5.5–23 days) in CG. No serious adverse events were observed in either group. Conclusions Ketamine as an adjunct analgosedative agent appeared to be feasible and safe with no negative impact on outcomes, including hemodynamics. This pilot RCT identified areas of improvement in study protocol before conducting a large, adequately powered, multicenter RCT which is likely justified to investigate ketamine association with patient-centered outcomes further. Trial registration ClinicalTrials.gov: NCT04075006. Registered on 30 August 2019. Current controlled trials: ISRCTN14730035. Registered on 3 February 2020

Purpose Evaluate the feasibility, acceptability and potential efficacy of a form of online therapy for clinical depression and/or anxiety in people living with advanced cancer. Methods A single-arm open trial of a six-lesson clinician-supervised, internet-delivered cognitive behavioural therapy (iCBT) transdiagnostic intervention (iCanADAPT Advanced) was undertaken. Qualitative (semi-structured telephone interview conducted at 3-months) and quantitative data (questionnaires collected at pre-, post-, and 3-month follow-up) were analysed. Results 27 participants partook (26 women, 56% breast cancer, mean age 56yo; average number of mental health diagnoses 1.8, with majority (81%) meeting criteria for generalised anxiety disorder). Feasibility - Unanticipated numbers (48%) of participants had physical health deterioration (cancer progression or death). iCBT had high adherence overall (completion rates: 37% did 6 lessons; 70% did 4 lessons) but adherence was higher for those whose cancer remained stable (completion rates: 43% did 6 lessons; 85% did 4 lessons). Acceptability - the intervention was acceptable to the majority of participants, with high treatment satisfaction. Advisory data was achieved regarding future versions. Potential efficacy - regardless of physical health status, participants who completed the iCBT showed a significant decrease over time in anxiety and depression symptoms. Conclusions Online therapies may be useful in assisting those living with advanced cancer dealing with clinical depression and anxiety disorders. The specific modality of clinician supervised iCBT has significant potential to be a suitable modality of online therapy., Highlights • There are few internet interventions to help people living with advanced cancer • An open trial of internet-delivered cognitive behavioural therapy (iCBT) was done • Recruitment was feasible but engagement for some participants was hindered due to cancer progression • Some participants encountered concentration and memory problems with online use • The iCBT intervention was acceptable and iCBT could improve accessibility for select patients with advanced cancer

Background Interactive Nutrition Comics for Urban Minority Youth (Intervention INC) is an innovative, web-based interactive comic tool for dietary self-management, which aims to decrease obesity risk among urban minority preadolescents. The feasibility and acceptability of Intervention INC was assessed by implementing a two-group randomized pilot study. To date, intervention studies have typically faced various barriers in recruiting and retaining study participants. The purpose of this paper is to describe recruitment and retention activities from this study and in particular, discuss challenges faced, strategies implemented, and lessons learned. Methods Black/AA and Latino children (ages 9–12 years) and their parent/guardian were recruited from East Harlem/Harlem, New York. Recruitment strategies included flyering in the community, having a convenient study location, providing participation incentives, and partnering with community/school-based organizations. Potential participants were screened for eligibility; enrollees completed online surveys and interviews at baseline (T1), intervention midpoint (T2), intervention end (T3), and 3-months post-intervention (T4). Retention strategies included flexible scheduling, reminder calls/texts, incremental compensation, and consistent study staff. Results Eighty-nine enrolled dyads completed a T1 visit (August to November 2017) and were randomized to the experimental (E, n = 45) or comparison (C, n = 44) group. Enrolled dyads learned about the study through community events (39%), community flyering (34%), friend/referral (15%), or a community clinic partner (12%). T1 child demographics were mean age = 10.4 ± 1.0 years, 61% female, 62% Black and 42% Latino, and 51% overweight/obese; parent demographics were mean age = 30.8 ± 8.9 years, 94% female, and 55% Black and 45% Latino. Survey completion rates by dyad were high throughout the study: T2, 87%; T3, 89%; and T4, 84%. Average data collection per session was 65 min. Parents at T4 (n = 76) felt they received enough study information (97%) and that their questions were answered properly (80%). Eighty-one percent of children at T4 (n = 75) were very satisfied/extremely satisfied with how study staff communicated and interacted with them. Conclusion Effective recruitment strategies consisted of community events and flyering, while a variety of retention strategies were also used to successfully engage urban Black/AA and Latino families in this study. Though our findings are limited to only Latino and Black families in low-income neighborhoods, we have identified successful strategies for this specific high-risk population and potentially similar others. Trial registration ClinicalTrials.gov, NCT03165474, registered 15 May 2017

Background Patients with stroke-associated pneumonia experience poorer outcomes (increased hospital stays, costs, discharge dependency, and risk of death). High-quality, organized oral healthcare may reduce the incidence of stroke-associated pneumonia and improve oral health and quality of life. Aims We piloted a pragmatic, stepped-wedge, cluster randomized controlled trial of clinical and cost effectiveness of enhanced versus usual oral healthcare for people in stroke rehabilitation settings. Methods Scottish stroke rehabilitation wards were randomly allocated to stepped time-points for conversion from usual to enhanced oral healthcare. All admissions and nursing staff were eligible for inclusion. We piloted the viability of randomization, intervention, data collection, record linkage procedures, our sample size, screening, and recruitment estimates. The stepped-wedge trial design prevented full blinding of outcome assessors and staff. Predetermined criteria for progression included the validity of enhanced oral healthcare intervention (training, oral healthcare protocol, assessment, equipment), data collection, and stroke-associated pneumonia event rate and relationship between stroke-associated pneumonia and plaque. Results We screened 1548/2613 (59%) admissions to four wards, recruiting n = 325 patients and n = 112 nurses. We observed marked between-site diversity in admissions, recruitment populations, stroke-associated pneumonia events (0% to 21%), training, and resource use. No adverse events were reported. Oral healthcare documentation was poor. We found no evidence of a difference in stroke-associated pneumonia between enhanced versus usual oral healthcare ( P = 0.62, odds ratio = 0.61, confidence interval: 0.08 to 4.42). Conclusions Our stepped-wedge cluster randomized control trial accommodated between-site diversity. The stroke-associated pneumonia event rate did not meet our predetermined progression criteria. We did not meet our predefined progression criteria including the SAP event rate and consequently were unable to establish whether there is a relationship between SAP and plaque. A wide confidence interval did not exclude the possibility that enhanced oral healthcare may result in a benefit or detrimental effect. Trial Registration NCT01954212.

With the rise in popularity and availability of simulators for the aircraft training of pilots, numerous side effects of that technology have been noted among their users. The symptoms of simulator sickness are similar to the symptoms of motion sickness. Dizziness, nausea, as well as spatial disorientation and a limited capacity for concentration may be observed. However, those symptoms depend on individual user's predispositions.The aim of the research was to assess the probability of occurrence of simulator sickness during exercises in virtual reality, and its impact on the effectiveness of training. Thirty two military and 16 civilian pilots of various types of aircraft took part in the research. For the subjective assessment of the psychophysical condition of the pilots, a questionnaire based oniSimulator Sickness Questionnaire/i(SSQ) was used.Four main factors that are associated with the prevalence of simulator sickness have been identified, i.e., age, a variety of missions, a type of aircraft and susceptibility to motion sickness.Due to the individual characteristics of each person, determining the risk of occurrence of simulator sickness seems to be difficult. However, there are some factors that increase the probability of getting sick, including cold, medications, lack of sleep and general fatigue. The lack of knowledge about simulator sickness among aircraft pilots appears rather alarming. When access to virtual reality is so wide, the possible ways of expanding the knowledge in this area should be considered, especially in order to obtain better results in simulator sessions. Med Pr. 2019;70(3):317-25.Wraz z większą popularnością i dostępnością szkoleń symulatorowych wykorzystywanych do treningu pilotów zaobserwowano pojawianie się licznych efektów ubocznych tej technologii. Objawy choroby symulatorowej są zbliżone do dolegliwości związanych z chorobą lokomocyjną – m.in. zawroty głowy, wymioty, a także dezorientacja przestrzenna oraz ograniczenie zdolności koncentracji. Zależą one jednak od indywidualnych predyspozycji użytkowników symulatorów.Celem pracy była ocena prawdopodobieństwa wystąpienia choroby symulatorowej podczas ćwiczeń w wirtualnej rzeczywistości oraz jej wpływu na efektywność szkolenia. Próba badawcza liczyła 32 wojskowych i 16 cywilnych pilotów różnych typów statków powietrznych. W celu subiektywnej oceny stanu psychofizycznego pilotów wykorzystano ankietę wzorowaną naiSimulator Sickness Questionnaire/i(SSQ).Wyodrębniono 4 główne czynniki wpływające na możliwość wystąpienia choroby symulatorowej: wiek badanej osoby, zróżnicowanie misji, rodzaj statku powietrznego i podatność na chorobę lokomocyjną.W związku z indywidualnymi predyspozycjami badanych pilotów określenie ryzyka wystąpienia choroby symulatorowej wydaje się trudne. Istnieją jednak czynniki, które zwiększają prawdopodobieństwo zachorowania – przeziębienie, spożywane leki, niedobór snu i ogólne zmęczenie. Niepokojący jest brak wiedzy na temat choroby symulatorowej wśród pilotów. Warto zatem zastanowić się nad możliwościami edukacji tej grupy zawodowej w tym zakresie, przede wszystkim w celu uzyskiwania lepszych wyników w sesjach symulatorowych, w sytuacji łatwego dostępu do wirtualnej rzeczywistości. Med. Pr. 2019;70(3):317–325.

Presented work is primarily oriented on the experimental verification of the influence of fatigue on the psychological condition of the flying personnel, using psychological and performance tests. For the evaluation of a pilot performance, the 24 hours experiment was conducted. In total, eight subjects participated in the experimental measurements. Eight participants went through several tests, including simulator flights, to investigate the effects of the fatigue on the results of psychological measurements. Measurements included workload evaluation, using NASA task load evaluation concept and performance testing, using the so-called OR-test. Significant statistical differences between measurements performed during 24 hours were not found in the case of NASA task load Scores. In the case of OR-test, Friedman ANOVA and subsequent post-hoc analysis show that the greatest decrease in performance was observed in approximately 22 hours of wakefulness, i.e. approximately in half of the measuring process. The concept of 24-hour measurements for the quantification of fatigue is not commonly used yet as well as objectivization using performance testing. As the apparent effect of fatigue is mainly on performance testing results, it can be argued that this work could serve as a basis for further studies on fatigue. Also, it could serve as a support for introducing new pilots' psychological testing procedures in the future, which could contribute to current efforts to improve aviation safety.

Background Migraine is one of the most common neurological disorders in clinical practice and is a substantial cause of disability worldwide. Current approaches to therapy are primarily based on medication but are often limited by inadequate effectiveness and common side effects. Newer, more effective medications are expensive. Mindfulness-based stress reduction (MBSR), an 8-week classroom-based meditation intervention, is inexpensive, has no known side effects, and has demonstrated clinically meaningful effectiveness for several chronic-pain syndromes. In addition, MBSR has shown promising results for migraine therapy in a few small case studies and pilot studies. We present here the protocol for a two-arm randomized controlled pilot trial of MBSR for moderate-to-severe episodic migraine, which, if successful, will form the basis for a fully powered clinical trial. Methods/design This study, set in Northern California, is a two-arm parallel-comparison single-blinded randomized controlled pilot trial with the goal of recruiting approximately 60 participants with moderate-to-severe episodic migraine. The feasibility outcomes include ability and time required to recruit, adherence to the MBSR treatment, and ability to measure outcomes using 31-day headache diaries and patient-reported questionnaire data. The active treatment arm consists of an 8-week community-based MBSR class plus usual care, and the wait-list control group is usual care. Recruitment is underway and expected to be complete by the end of 2018. Discussion To our knowledge, this is the first pragmatic trial in the U.S. of MBSR for migraine using community-based classes, and if it proves viable, we plan to conduct a fully powered trial to determine the effectiveness of the intervention for reducing headache days for moderate-to-severe episodic migraineurs. Trial registration Clinicaltrials.gov, NCT02824250. Registered on 6 July 2016. Electronic supplementary material The online version of this article (10.1186/s13063-019-3355-y) contains supplementary material, which is available to authorized users.

Training peer leaders (PLs) as implementation agents is a state-of-the-art approach in prevention, but the field lacks frameworks for providing support. Text messaging, a powerful tool for direct intervention, may be useful in this regard. We introduce a conceptual framework for engaging, retaining, and educating adolescent PLs and conduct a pilot test of this framework using text messages for delivery to middle school PLs in a new, peer-led substance use prevention program. Fifty eighth-graders were recruited as PLs. We used a newly-developed framework to create text messages to strengthen peer leaders’: (a) mission, agency, and team identity; (b) connection to adult mentors; (c) content knowledge and application to their own lives; and (d) preparation for prevention activities. Thirty-four texts were sent to PLs over 4 months. PL replies and participation were recorded to track engagement. Forty-one PLs (71%) received texts and completed baseline and post-program surveys. Parents and school staff completed post-program questionnaires. Eighty-five percent of PLs responded to at least one text message. Response rates for specific messages varied from 22 to 56%. Students were most likely to reply to texts about preparation for their own prevention activities in the school. Ninety-five percent of PLs said they read messages even when they did not reply. Eighty-three percent of PLs said the messages helped them accomplish their mission. PLs reported that they wanted to receive messages in the future. PL attendance had very little variability in two of the three schools, but replies to texts were associated with better attendance in one school. Our study provides a framework for supporting adolescent peer leaders in a network intervention. Automated text messaging supporting middle school PLs was feasible, engaging, and well-received. Texting activity was associated with participation in school-based activities. Future priorities include systematically varying text support to determine its true effect on implementation and on involvement by less engaged PLs.

Introduction: Most of previous studies on dyslipidemia among pilots were cross-sectional surveys which cannot explore the temporal trend of dyslipidemia, and these studies were normally conducted at least five years ago. In addition, studies focusing on pilots in Southwest China are scarce. This study aimed to describe the prevalence of and trends in dyslipidemia among pilots from an airline in Southwest China. Methods: This cross-sectional study evaluated the prevalence of adverse concentrations of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG) among all pilots from one airline in Southwest China in 2015. Analyses of linear trends in age-adjusted prevalence of dyslipidemia were conducted overall across a 3-year period (2013, 2014, and 2015). Results: In 2015, 3.4% of participating pilots had a high TC concentration, 16.4% had a high TG concentration, 2.6% had a high LDL-C concentration, 25.1% had a low HDL-C concentration, and 33.1% had dyslipidemia. Between 2013 and 2015, there were decreasing linear trends in age-adjusted prevalence of high TG (32% vs. 19.9%; P < 0.001) and dyslipidemia (51.9% vs. 38.4%; P < 0.001). During this 3-year period, declining trends were also observed in age-adjusted prevalence of LDL-C (10.0% vs. 4%; P < 0.001) and HDL-C (33.2% vs. 28.3%; P = 0.015). However, there was no change from 2013 to 2015 in age-adjusted prevalence of high TC (2.8% vs. 5.0%; P = 0.168). Conclusion: From 2013 to 2015, there were favorable trends in the prevalence of high TG, low HDL-C, high LDL-C, and overall dyslipidemia but no significant change in high TC among pilots from one airline in southwest China. The reasons for these trends need to be further explored.

Background Adherence to adjuvant endocrine therapy is affected by medication side-effects and associated distress. Previous interventions focused on educating women to enhance adherence have proved minimally effective. We co-designed an Acceptance and Commitment Therapy (ACT) intervention to enhance medication decision-making and quality of life by targeting a broader range of factors, including side-effect management and psychological flexibility. This study aims to establish key trial parameters, assess the acceptability of the intervention and the extent to which it can be delivered with fidelity, and to demonstrate “proof of principle” regarding its efficacy on primary and process outcomes. Methods The ACTION intervention includes an individual 1:1 ACT session followed by three group sessions involving 8–10 women and two practitioner psychologists. Participants are also provided with access to a website containing evidence-based methods for self-managing side-effects. The ACT sessions were adapted during the COVID-19 pandemic to be remotely delivered via video conferencing software. To evaluate the feasibility and acceptability of this intervention, a multi-site, exploratory, two-arm, individually randomised external pilot trial with a nested qualitative study will be undertaken. Eighty women with early stage breast cancer prescribed adjuvant endocrine therapy will be randomised (1:1) to receive treatment as usual or treatment as usual plus the ACTION intervention. The planned future primary outcome is medication adherence assessed by the ASK-12 measure. Progression to a phase III RCT will be based on criteria related to recruitment and follow-up rates, acceptability to patients, competency and fidelity of delivery, and proof of principle for change in medication adherence. Discussion This external pilot trial will be used to ascertain the feasibility of undertaking a future phase III RCT to definitively evaluate an ACT-based intervention to support medication taking behaviour and quality of life in women with early stage breast cancer on adjuvant endocrine therapy. Trial registration ISRCTN: 12027752. Registered 24 December 2020, https://doi.org/10.1186/ISRCTN12027752

Coordination of primary care is essential to improving care delivery within health systems, especially for older adults with increased health/social needs. A program jointly funded by the Canadian Foundation for Healthcare Improvement and Canadian Frailty Network, was implemented in a nurse practitioner-led clinic to address the gap in frailty care for older adults. The clinic was situated within a health and social services organization with a mandate to enhance the quality of life of older adults living in the community. Through this program, a frailty assessment pathway and social/clinical prescriptions were implemented with necessary adaptations as a result of COVID-19.

Background Over the last decade, virtual reality (VR) has emerged as a cutting-edge technology in stroke rehabilitation. VR is defined as a type of computer-user interface that implements real-time simulation of an activity or environment allowing user interaction via multiple sensory modalities. In a stroke population, VR interventions have been shown to enhance motor, cognitive, and psychological recovery when utilized as a rehabilitation adjunct. VR has also demonstrated noninferiority to usual care therapies for stroke rehabilitation. Objective The proposed pilot study aims to (1) determine the feasibility and tolerability of using a therapeutic VR platform in an inpatient comprehensive stroke rehabilitation program and (2) estimate the initial clinical efficacy (effect size) associated with the VR platform using apps for pain distraction and upper extremity exercise for poststroke neurologic recovery. Methods This study will be conducted in the Comprehensive Integrated Inpatient Rehabilitation Program at the James A Haley Veterans’ Hospital. Qualitative interviews will be conducted with 10 clinical staff members to assess the feasibility of the VR platform from the clinician perspective. A prospective within-subject pretest-posttest pilot design will be used to examine the tolerability of the VR platform and the clinical outcomes (ie, upper extremity neurologic recovery, hand dexterity, pain severity) in 10 veteran inpatients. A VR platform consisting of commercially available pain distraction and upper extremity apps will be available at the participants’ bedside for daily use during their inpatient stay (approximately 4-6 weeks). Clinician interviews will be analyzed using qualitative descriptive analysis. Cohen d effect sizes with corresponding 95% CIs will be calculated for upper extremity neurologic recovery, hand dexterity, and pain. The proportion of participants who achieve minimal clinically important difference after using the VR platform will be calculated for each clinical outcome. Results This study was selected for funding in August 2020. Institutional review board approval was received in October 2020. The project start date was December 2020. The United States Department has issued a moratorium on in-person research activities secondary to COVID-19. Data collection will commence once this moratorium is lifted. Conclusions Our next step is to conduct a large multi-site clinical trial that will incorporate the lessons learned from this pilot feasibility study to test the efficacy of a VR intervention in inpatient rehabilitation and transition to home environments. When VR is used in patients’ rooms, it serves to provide additional therapy and may reduce clinician burden. VR also presents an opportunity similar to home-based practice exercises. VR can be implemented in both clinical settings and people’s own homes, where engagement in ongoing self-management approaches is often most challenging. This unique experience offers the potential for seamless transition from inpatient rehabilitation to the home. International Registered Report Identifier (IRRID) PRR1-10.2196/26133

Abstract Having access to parenting interventions in the early years is key to improve the developmental outcomes of children with neurodevelopmental problems. The Incredible Years® (IY) Parent Program is a group intervention that has demonstrated efficacy in terms of reducing stress in parents, as well as improving behavioral, emotional, and social outcomes in children. The program has been recently adapted for families of children with autism or language delays (IY-ASLD®). This intervention has not yet been implemented in the Spanish Public Health System, where there is a scarcity of evidence-based interventions being offered to families with young children presenting neurodevelopmental problems. The main aims of this study are to determine the feasibility of implementing the IY-ASLD® program within Spanish Child Mental Health Services and to examine parents’ acceptability and satisfaction with the intervention. As a secondary objective, we aim to evaluate its preliminary effectiveness in terms of reducing parental stress and behavioral difficulties in their children. The FIRST STEPS study is a multicenter, pilot randomized controlled trial comparing the IY-ASLD® program with a treatment-as-usual (TAU) condition. Approximately 70 families of children with autism spectrum disorder (ASD) and preterm children with communication and/or socialization difficulties (aged 2–5 years) will be recruited. Families will be assessed prior to randomization and after the intervention. Due to the COVID-19 pandemic, the intervention will consist of 22 weekly online sessions (approximately 6 months). The FIRST STEPS pilot trial will demonstrate the feasibility and acceptability of reliably implementing the IY-ASLD® program within the Spanish Public Health System. The results of this study could represent the first step to inform policymakers in Spain when designing evidence-based healthcare pathways for families of children presenting ASD symptoms or neurodevelopmental difficulties at early stages. Trial registration ClinicalTrials.gov NCT04358484. Registered on 04 April 2020

Background As suggested by the World Health Organization, breastfeeding peer support is being introduced worldwide to support women’s breastfeeding needs. Evidence has shown that when such support is offered to women, the duration and exclusivity of breastfeeding is increased. We developed an innovative home-based intervention to sustain exclusive breastfeeding in Hong Kong. However, potential barriers must be addressed before a full randomised controlled trial (RCT) is conducted. The aim of this study was to determine the feasibility of a breastfeeding support programme with home-based visits from peer supporters over a six month period among postpartum Chinese women in Hong Kong. Methods We conducted a feasibility and pilot randomised controlled trial. Twenty primiparous women intending to breastfeed their healthy term singleton infant were recruited from a hospital in Kowloon, Hong Kong between February and March 2019. Participants were randomly allocated to the intervention or control group. Participants in the intervention group received five home-based visits with a peer supporter over a six month period, as well as standard care, whereas participants in the control group received standard care only. We assessed feasibility, compliance, and acceptability of the breastfeeding peer support programme. Other outcomes assessed were breastfeeding self-efficacy, duration, and exclusivity. Results It was feasible to recruit and train existing peer supporters, and peer supporters were able to deliver the intervention, which was acceptable to women, but rates of stopping the intervention and loss to follow-up were high. There was higher retention seen within the first month. Women interviewed at the end of the study reported that the intervention was positive. The cessation risk of any, and exclusive breastfeeding were not statistically different between the intervention and control groups. Conclusions This study provided valuable information on feasibility of the trial design and intervention. Modifications to the intervention, such as targeting women with lower breastfeeding self-efficacy, or combining home visits with technology and telephone follow-up may be more appropriate in a larger trial. Implementing the programme early during the antenatal phase and tailoring peer support to most appropriately sustain exclusive breastfeeding and other feeding modes should be incorporated in a future home-based peer support arm. Trial registration NCT03705494 on 15 Oct 2018.

Although effective in major depressive disorder (MDD), repetitive transcranial magnetic stimulation (rTMS) is costly and complex, limiting accessibility. To address this, we tested the feasibility of novel rTMS techniques with cost-saving opportunities, such as an open-room setting, large non-focal parabolic coils, and custom-built coil arms. We employed a low-frequency (LF) 1 Hz stimulation protocol (360 pulses per session), delivered on the most affordable FDA-approved device. MDD participants received an initial accelerated rTMS course (arTMS) of 6 sessions/day over 5 days (30 total), followed by a tapering course of daily sessions (up to 25) to decrease the odds of relapse. The self-reported Beck Depression Inventory II (BDI-II) was used to measure severity of depression. Forty-eight (48) patients completed the arTMS course. No serious adverse events occurred, and all patients reported manageable pain levels. Response and remission rates were 35.4% and 27.1% on the BDI-II, respectively, at the end of the tapering course. Repeated measures ANOVA showed significant changes of BDI-II scores over time. Even though our protocol will require further improvements, some of the concepts we introduced here could help guide the design of future trials aiming at increasing accessibility to rTMS.

Background Collaborative decision-making is an innovative decision-making approach that assigns equal power and responsibility to patients and providers. Most veterans with serious mental illnesses like schizophrenia want a greater role in treatment decisions, but there are no interventions targeted for this population. A skills-based intervention is promising because it is well-aligned with the recovery model, uses similar mechanisms as other evidence-based interventions in this population, and generalizes across decisional contexts while empowering veterans to decide when to initiate collaborative decision-making. Collaborative Decision Skills Training (CDST) was developed in a civilian serious mental illness sample and may fill this gap but needs to undergo a systematic adaptation process to ensure fit for veterans. Methods In aim 1, the IM Adapt systematic process will be used to adapt CDST for veterans with serious mental illness. Veterans and Veteran’s Affairs (VA) staff will join an Adaptation Resource Team and complete qualitative interviews to identify how elements of CDST or service delivery may need to be adapted to optimize its effectiveness or viability for veterans and the VA context. During aim 2, an open trial will be conducted with veterans in a VA Psychosocial Rehabilitation and Recovery Center (PRRC) to assess additional adaptations, feasibility, and initial evidence of effectiveness. Discussion This study will be the first to evaluate a collaborative decision-making intervention among veterans with serious mental illness. It will also contribute to the field’s understanding of perceptions of collaborative decision-making among veterans with serious mental illness and VA clinicians, and result in a service delivery manual that may be used to understand adaptation needs generally in VA PRRCs. Trial registration ClinicalTrials.gov Identifier: NCT04324944

Background Current guidelines recommend supervised exercise training (SET) as a first-line treatment in patients with intermittent claudication (IC). SET has been shown to be more effective than home-based exercise therapy (HBET). However, the lack of available SET programs hampers broad SET implementation in clinical practice. Objective The aim of this study is to assess patient satisfaction and acceptability of a structured HBET program using wearable technology and elastic band resistance exercises. Methods A total of 20 patients with IC (Rutherford 1-3) with internet access and currently not engaged in structured exercise training were recruited in a pragmatic observational pilot study. Participants were instructed to complete 3 walking sessions and 2 elastic band resistance exercise sessions per week in their home environment during a 4-week period. Patient satisfaction and acceptability were assessed using a 5-point Likert scale questionnaire (1-2=very unsatisfied, 3=neutral, and 4-5=very satisfied) evaluating the materials and intervention content. Secondary outcomes were evaluated at baseline and at completion of the 4-week intervention and included maximal walking distance (MWD) and pain-free walking distance (PFWD), physical fitness, and patient-reported outcomes on quality of life, walking capacity, levels of kinesiophobia, and self-efficacy. Statistically significant changes were tested using paired t tests or Wilcoxon signed-rank tests. Results All patients (15 men, 5 women; mean age 64.6, SD 10.6 years; range 41-81 years) completed the 4-week intervention and were highly satisfied with the program (mean overall score 4.5, SD 0.5). Patients’ questionnaire responses documented willingness to recommend the exercise program to other patients (mean 4.5, SD 0.5; median 4.5) and preference for continuing the intervention (mean 4.3, SD 0.5; median 4). Furthermore, participants endorsed the use of the sports watches to track walking sessions (mean 4.25, SD 0.6; median 4), felt safe (mean 4.4, SD 0.6; median 4), and appreciated personal feedback (mean 4.55, SD 0.5; median 5) and flexibility of training (mean 4.1, SD 0.7; median 4). Resistance training was not preferred over walking training (mean 2.65, SD 0.8; median 3). In addition, PFWD (+89 m; P=.001), MWD (+58 m; P=.03), Walking Impairment Questionnaire distance score (+0.18; P=.01), activity-related scores (+0.54; P Conclusions Patients with IC were satisfied and accepted technology to monitor and guide HBET, with observed short-term effectiveness regarding walking capacity and quality of life. However, elastic band resistance exercises as a part of HBET were not preferred over progressive walking. Trial Registration ClinicalTrials.gov NCT04043546; https://clinicaltrials.gov/ct2/show/NCT04043546

Background Children with profound intellectual and multiple disabilities (PIMD) or severe motor and intellectual disabilities (SMID) only communicate through movements, vocalizations, body postures, muscle tensions, or facial expressions on a pre- or protosymbolic level. Yet, to the best of our knowledge, there are few systems developed to specifically aid in categorizing and interpreting behaviors of children with PIMD or SMID to facilitate independent communication and mobility. Further, environmental data such as weather variables were found to have associations with human affects and behaviors among typically developing children; however, studies involving children with neurological functioning impairments that affect communication or those who have physical and/or motor disabilities are unexpectedly scarce. Objective This paper describes the design and development of the ChildSIDE app, which collects and transmits data associated with children’s behaviors, and linked location and environment information collected from data sources (GPS, iBeacon device, ALPS Sensor, and OpenWeatherMap application programming interface [API]) to the database. The aims of this study were to measure and compare the server/API performance of the app in detecting and transmitting environment data from the data sources to the database, and to categorize the movements associated with each behavior data as the basis for future development and analyses. Methods This study utilized a cross-sectional observational design by performing multiple single-subject face-to-face and video-recorded sessions among purposively sampled child-caregiver dyads (children diagnosed with PIMD/SMID, or severe or profound intellectual disability and their primary caregivers) from September 2019 to February 2020. To measure the server/API performance of the app in detecting and transmitting data from data sources to the database, frequency distribution and percentages of 31 location and environment data parameters were computed and compared. To categorize which body parts or movements were involved in each behavior, the interrater agreement κ statistic was used. Results The study comprised 150 sessions involving 20 child-caregiver dyads. The app collected 371 individual behavior data, 327 of which had associated location and environment data from data collection sources. The analyses revealed that ChildSIDE had a server/API performance >93% in detecting and transmitting outdoor location (GPS) and environment data (ALPS sensors, OpenWeatherMap API), whereas the performance with iBeacon data was lower (82.3%). Behaviors were manifested mainly through hand (22.8%) and body movements (27.7%), and vocalizations (21.6%). Conclusions The ChildSIDE app is an effective tool in collecting the behavior data of children with PIMD/SMID. The app showed high server/API performance in detecting outdoor location and environment data from sensors and an online API to the database with a performance rate above 93%. The results of the analysis and categorization of behaviors suggest a need for a system that uses motion capture and trajectory analyses for developing machine- or deep-learning algorithms to predict the needs of children with PIMD/SMID in the future.

Introduction: Advanced glycation end products (AGEs) in diet and serum are positively correlated with chronic conditions such as type 2 diabetes and cognitive decline. Dietary reduction of AGEs was shown to reduce their level in serum and to have a beneficial effect on metabolic biomarkers. However, in part due to limitations of feasibility, clinical trials have not tested its effect on cognition in elderly. The current pilot study examines the feasibility of AGE reduction in elderly with diabetes in terms of recruitment and retention.Methods: The design is a randomized controlled pilot trial of dietary AGEs in elderly with type 2 diabetes (clinicaltrials.gov NCT02739971). Recruitment followed two stages: we first recruited participants with mild cognitive impairment (MCI), and after expanding inclusion criteria, we later recruited cognitively normal participants with subjective memory complaints (SMCs). Participants were randomized to two arms. Participants in the control arm received standard of care (SOC) guidelines for good glycemic control; those in the experimental arm, in addition to SOC guidelines, were instructed to lower their dietary AGE intake, primarily by changing their cooking methods. Participants were closely followed for dietary adherence over 6 months and evaluated before and after the intervention for adherence to the assigned diet, blood tests, cognitive performance, and brain MRI.Results: Seventy-five participants (52 with MCI and 23 cognitively normal with SMCs) were recruited primarily through mass mailing and advertising in social media websites. Seventy participants finished the study, and dropout was similar in both groups (7.5% in control vs. 5.7% in intervention, p = 0.757). The majority (57.5%) of participants in the AGEs-lowering arm showed very high adherence with the dietary guidelines.Discussion: Targeting feasible lifestyle modifications in high-risk populations could prevent substantial cases of cognitive decline. Observational evidence supports that AGEs may contribute to cognitive decline; however, the cognitive effect of reducing AGEs exposure has yet to be evaluated in a randomized controlled trial (RCT). The results of our pilot trial delineate a methodology including effective recruitment strategies, population of choice, and ways to assure high adherence during lifestyle modifications, and significantly advance progress toward a definitive and well-powered future RCT.

Objectives Pilots with coronary artery disease (CAD) are at increased risk of myocardial infarction, stroke, and possibly death. Return to flying duties may be considered after a detailed risk assessment. The aim of this retrospective case series is to describe the return to flying duty process. Methods We conducted a retrospective case review of pilots diagnosed with CAD at the Institute of Aviation Medicine (IAM), Royal Malaysian Air Force (RMAF) in October 2020. Results Thirteen cases of CAD were included in the review. Ten pilots were diagnosed after developing acute coronary syndrome; the remaining three pilots were diagnosed during a routine medical examination via an exercise stress test. Twelve pilots required a revascularization procedure. A total of 11 pilots (84.6%) were recertified for flying duties, while another two were disqualified. The duration to recertification for these 11 pilots was between three months and one year. Conclusions The risk assessment was initiated with initial risk‐stratification using population‐appropriate risk calculator combined with the 4 × 4 aeromedical risk matrix. The reassessment of return to flying after coronary artery disease must be carried out no sooner than six months after the event. Pilots must be hemodynamically stable with no evidence of significant inducible ischemic left and a minimum 50% of ventricular ejection fraction (LVEF). A follow‐up is recommended at the initial six months after recertification and then annually with a routine noninvasive cardiac assessment.

Background Mild‐moderate psoriasis vulgaris is a common dermatological autoimmune condition with limited conventional therapeutic options. Safe and effective adjunct therapies to topical non‐steroidal antipsoriatic therapy are needed. The oral Chinese herbal medicine (CHM) formula PSORI‐CM01 has been evidenced potential antipsoriatic pharmacological activity. This article reports a pilot study which was designed as a double‐blinded, placebo‐controlled randomized controlled trial (RCT) evaluating the effects of PSORI‐CM01 when added to topical calcipotriol cream. Methods People with moderate psoriasis vulgaris were randomized to receive oral PSORI‐CM01 or placebo administered for 12 weeks in combination with calcipotriol. The primary clinical outcome was the change of psoriasis area severity index (PASI) score at week 12 and week 24. Secondary clinical outcomes were PASI75, PASI50, relapse rate, change in body surface area, dermatology life quality index and Skindex29, and adverse events (AEs). Participants’ satisfaction and willingness to repeat were also assessed. Results The pilot study was conducted in Australia and China, 29 participants were randomized with 26 completed the treatment and follow‐up. Participants’ baseline basic characteristics were comparable. No between‐group statistical significance was found on pre‐defined clinical outcome measures, although there seemed a trend of treatment effects favoring the combination of PSORI‐CM01 with calcipotriol. Frequency and severity of AEs were similar between two groups, with no severe AEs reported. Conclusions The design and duration of the study appears feasible. A proper powered RCT with slight adjustments in the methods is needed to reveal the add‐on effects of oral CHM PSORI‐CM01. The experience and results from this pilot study will contribute to the refine of objectives and design of a future study, and assist the sample size calculation for the full‐scale RCT.

This paper describes a ‘proof-of-concept’ pilot of the ‘Early FDAC model’. The evaluated Family Drug and Alcohol Court (FDAC) model, on which Early FDAC is based, is summarised and the rationale for introducing the pilot variation is set out. This short paper describes the learning from the pilot that set out to work with 30 families across three FDAC teams between 2015 and 2019. At the time of the pilot, there were, and remain, few other interventions in England for pregnant mothers who have already had children removed. An adaptation of the evaluated FDAC model suggested itself because of the overlap with families in public law care proceedings and emerging evidence that FDAC delivers a better experience of justice for families and professionals, better outcomes for children and families and better use of public money. Pilot families were engaged as soon as possible in the pregnancy (hence ‘Early’), and continued to receive support for up to two years. The process started in pre-proceedings with the aim of avoiding court. Where proceedings were necessary, cases were heard in an FDAC court, with provision for a post-proceedings phase. There were problems with recruitment and engagement and families had fewer ‘solvable problems’. Nevertheless, outcomes were promising, with 18 families keeping their children. This represents one-third of the referred families and almost two-thirds of the families who undertook a ‘Trial for Change’.

Background Healthcare associated infections (HAI) are estimated to affect up to 15% of hospital inpatients in low-income countries (LICs). A critical but often neglected aspect of HAI prevention is basic environmental hygiene, particularly surface cleaning and linen management. TEACH CLEAN is an educational intervention aimed at improving environmental hygiene. We evaluated the effectiveness of this intervention in a pilot study in three high-volume maternity and newborn units in Dar es Salaam, Tanzania. Methods This study design prospectively evaluated the intervention as a whole, and offered a before-and-after comparison of the impact of the main training. We measured changes in microbiological cleanliness [Aerobic Colony Counts (ACC) and presence of Staphylococcus aureus] using dipslides, and physical cleaning action using gel dots. These were analysed with descriptive statistics and logistic regression models. We used qualitative (focus group discussions, in-depth interviews, and semi-structured observation) and quantitative (observation checklist) tools to measure why and how the intervention worked. We describe these findings across the themes of adaptation, fidelity, dose, reach and context. Results Microbiological cleanliness improved during the study period (ACC pre-training: 19%; post-training: 41%). The odds of cleanliness increased on average by 1.33 weekly during the pre-training period (CI = 1.11–1.60), and by 1.08 (CI = 1.03–1.13) during the post-training period. Cleaning action improved only in the pre-training period. Detection of S. aureus on hospital surfaces did not change substantially. The intervention was well received and considered feasible in this context. The major pitfalls in the implementation were the limited number of training sessions at the hospital level and the lack of supportive supervision. A systems barrier to implementation was lack of regular cleaning supplies. Conclusions The evaluation suggests that improvements in microbiological cleanliness are possible using this intervention and can be sustained. Improved microbiological cleanliness is a key step on the pathway to infection prevention in hospitals. Future research should assess whether this bundle is cost-effective in reducing bacterial and viral transmission and infection using a rigorous study design.

Background People experiencing homelessness have higher rates of HIV than those who are stably housed. Mental health needs, substance use problems, and issues unique to homelessness such as lack of shelter and transiency need to be considered with regard to HIV prevention. To date, HIV prevention interventions for young adults experiencing homelessness have not specifically addressed modifiable real-time factors such as stress, sexual or drug use urge, or substance use, or been delivered at the time of heightened risk. Real-time, personalized HIV prevention messages may reduce HIV risk behaviors. Objective This pilot study tested the initial efficacy of an innovative, smartphone-based, just-in-time adaptive intervention that assessed predictors of HIV risk behaviors in real time and automatically provided behavioral feedback and goal attainment information. Methods A randomized attention control design was used among young adults experiencing homelessness, aged 18-25 years, recruited from shelters and drop-in centers in May 2019. Participants were randomized to either a control or an intervention group. The intervention (called MY-RID [Motivating Youth to Reduce Infection and Disconnection]) consisted of brief messages delivered via smartphone over 6 weeks in response to preidentified predictors that were assessed using ecological momentary assessments. Bayesian hierarchical regression models were used to assess intervention effects on sexual activity, drug use, alcohol use, and their corresponding urges. Results Participants (N=97) were predominantly youth (mean age 21.2, SD 2.1 years) who identified as heterosexual (n=51, 52%), male (n=56, 57%), and African American (n=56, 57%). Reports of sexual activity, drug use, alcohol use, stress, and all urges (ie, sexual, drug, alcohol) reduced over time in both groups. Daily drug use reduced by a factor of 13.8 times over 6 weeks in the intervention group relative to the control group (Multimedia Appendix 4). Lower urges for sex were found in the intervention group relative to the control group over the duration of the study. Finally, there was a statistically significant reduction in reports of feeling stressed the day before between the intervention and control conditions (P=.03). Conclusions Findings indicate promising intervention effects on drug use, stress, and urges for sex in a hard-to-reach, high-risk population. The MY-RID intervention should be further tested in a larger randomized controlled trial to further investigate its efficacy and impact on sexual risk behaviors. Trial Registration ClinicalTrials.gov NCT03911024; https://clinicaltrials.gov/ct2/show/NCT03911024

Background: Ample evidence demonstrates that placebo effects are modulated by contextual factors. Few interventions, however, attempt to combine a broad range of these factors. Here, we explore the therapeutic power of placebos by leveraging factors including social proof, positive suggestion, and social learning. This study aimed to test the feasibility of an elaborate “super placebo” intervention to reduce symptoms of various disorders in a pediatric population.Methods: In a single-arm qualitative study, participants entered an inactive MRI scanner which they were told could help their brain heal itself through the power of suggestion. The sample included 11 children (6–13 years old) diagnosed with disorders known to be receptive to placebos and suggestion (Attention Deficit Hyperactivity Disorder, Tourette Syndrome, chronic skin picking, and migraines). The children were given positive suggestions during 2–4 placebo machine sessions over the span of approximately 1 month. We assessed open-ended treatment outcomes via recorded interviews and home visits.Results: The procedure was feasible and no adverse events occurred. Ten of the 11 parents reported improvements in their children after the intervention, ranging from minor transient changes to long-term reductions in subjective and objective symptoms (e.g., migraines and skin lesions).Discussion: These preliminary findings demonstrate the feasibility and promise of combining a broad range of contextual factors in placebo studies. Future research is needed to assess the causal effects of such interventions.