Pilot Randomized Controlled Trial Research Articles

A Pilot Randomized Control Trial Demonstrating the Efficacy of the SIESTA Sleep Hygiene Intervention.

Shorter sleep duration can negatively impact children's daytime functioning and health. Latino children living near urban areas in the Mainland U.S. and Island Puerto Rico (PR) can be exposed to urban poverty and sociocultural stressors that challenge optimal sleep outcomes. Interventions to improve urban Latino children's sleep health should consider families' cultural background and environmental context to enhance acceptability and feasibility. This work describes our stepwise, multimethod approach to adapting a culturally and contextually tailored "School Intervention to Enhance Latino Students' Time Asleep (SIESTA)" for sixth- to eighth-grade Latino children residing in Greater Providence and San Juan and findings from a pilot randomized control trial (RCT) demonstrating SIESTA's efficacy. Results indicated high acceptability and greater improvement of sleep duration and behaviors in SIESTA versus control participants. The SIESTA shows potential to improve sleep outcomes in urban Latino middle schoolers. Results will inform a large-scale RCT to evaluate SIESTA's effectiveness and barriers to implementation.

Social support for exercise from pregnancy to postpartum and the potential impact of a mobile application: A randomized control pilot trial in Southern United States

This study compared perceived social support among women of all body mass index (BMI) categories with an attempt to assess the efficacy of the BumptUp® mobile application to improve social support for exercise during pregnancy and postpartum. Thirty-five pregnant women living in Southern United States were included in the sample. The intervention group received access to the BumptUp® mobile application that was designed to promote physical activity during pregnancy and postpartum. The control group received an evidence-based educational brochure. Perceived social support for exercise was assessed at four-time points using the social support and exercise survey. Outcomes were evaluated at 23–25, 35–37 gestational weeks, and 6 and 12 weeks postpartum. Based on their pre-pregnancy weight and height, BMI was computed to categorize participants into lean, overweight, and obese groups. Social support across BMI categories and between control and intervention groups were compared using linear mixed-effect models. Women grouped in the overweight and obese BMI categories reported receiving significantly lower levels of social support for exercise than women in the lean category throughout pregnancy and postpartum during mid-pregnancy, late pregnancy, and at 12 weeks postpartum (p < 0.05). Although the intervention group received higher social support than the control group throughout all four assessment points, the difference was not statistically significant (p > 0.05). Women with a pre-pregnancy BMI of overweight and obese received lower social support for exercise during pregnancy and postpartum. The efficacy of BumptUp® to improve perceived social support for exercise in pregnancy and postpartum was not evident in the results.

Innovative online portal to support persons with obesity: STOP Project RCT

Abstract Background This research is part of the STOP project, a H2020 RISE project funded by European Commission (GA No 823978) to address the challenge of preventing obesity in Europe. The interdisciplinary European STOP project aims to establish a data and knowledge ecosystem as a basis for the STOP Portal to enable healthcare professionals in decision support, and persons with obesity in analysis and feedback of health information to optimise healthy nutrition. The aim of this current randomised controlled trial (RCT) was to determine the effectiveness of the newly developed system for adults with overweight and obesity to lose weight. Methods This was a pilot two-arm RCT: 1. intervention (n = 15) and 2. control (n = 15). All the participants were adults with overweight or obesity. The intervention group used the STOP Portal, while the control group did not use this system, no intervention. Participants were randomised into one of the two groups using a computer randomised programme. The primary outcome was percentage reported weight loss, by three months. Four data collection points for both the intervention and control groups at 1. baseline (month 0); 2. month 1; 3. month 2; and 4. month 3. The STOP Portal collects the following data: physiological data, knowledge resources, biomedical data, self-reporting activity and food data. Ethical approval was obtained. Results A total of 30 adults registered for this pilot RCT and participated up to three months. The results clearly indicated that adults (18 years+) who were overweight or obese and were in the intervention group and using the STOP Portal significantly (P &amp;lt; 0.001) lost body weight (kg; % weight loss; BMI). Thus the STOP Portal was significantly effective for participants losing body weight. Conclusions Overall, the STOP Portal is easy to use, fit for purpose and is significantly effective for adults with overweight and obesity to lose weight. Key messages • Innovative online portal, STOP Portal, is significantly effective for adults with overweight and obesity to lose weight. • This project addresses obesity management and prevention through the foundation of an innovative platform to support persons with obesity with a better nutrition.

Feasibility and acceptability of an online mental health intervention for pregnant women and their partners: a mixed method study with a pilot randomized control trial

BackgroundUntreated perinatal mood and anxiety disorders (PMAD) have short- and long-term health and social consequences; online cognitive behavioral therapy (CBT) interventions can reduce symptoms. Despite partner support being protective online interventions rarely target couples. This study builds on research on an existing CBT-based intervention, the Mothers and Babies Online Course (eMB), by testing its feasibility with prenatal couples.MethodsWe conducted a pilot, randomized, controlled feasibility trial using a 1:1 parallel design. To be eligible, participant dyads were pregnant people (between 13–30 weeks gestation and with a score of 10 or greater on either the GAD-7 or PHQ-9 scale indicating elevated symptoms of anxiety or depression) and their cohabitating partners, living in Missouri, with access to the internet; both in the dyad consented to participate. Recruitment occurred via Facebook ads, flyers, and a snowball approach. The intervention group received eMB, and the control group received a list of community resources. We examined retention and adherence data extracted from eMB analytics and study databases. All participants were given depression and anxiety scales at baseline, 4 and 8 weeks to test preliminary efficacy; satisfaction and acceptability were measured at trial end (i.e., eight weeks) and via interview.ResultsThere were 441 people who responded to recruitment materials, 74 pregnant people were screened; 19 partners did not complete enrolment, and 25 dyads were ineligible. There were 15 dyads per group (N = 30) who enrolled; all completed the study. The survey response rate was 90% but partners required nearly twice the number of reminders. No participant completed all lessons. Mean depression and anxiety scores dropped over time for dyads in control (M = -1.99, -1.53) and intervention (M = -4.80, -1.99). Intervention pregnant people’s anxiety significantly decreased (M = -4.05; 95% CI [0.82, 7.27]) at time two compared to control. Twelve pregnant people and four partners participated in post-intervention interviews and suggested improvements for eMB.ConclusionOnline dyadic interventions can potentially reduce PMAD symptoms. However, to feasibly study eMB with couples, strategies to increase program adherence are necessary. Tailoring interventions to overtly include partners may be advantageous.Trial registrationClinicalTrials.gov NCT05867680, 19/05/2023.

Repurposing Metformin for periodontal disease management as a form of oral-systemic preventive medicine

BackgroundDespite the improvements in treatment over the last decades, periodontal disease (PD) affects millions of people around the world and the only treatment available is based on controlling microbial load. Diabetes is known to increase the risk of PD establishment and progression, and recently, glucose metabolism modulation by pharmaceutical or dietarian means has been emphasised as a significant modulator of non-communicable disease development.MethodsThe impact of pharmaceutically controlling glucose metabolism in non-diabetic animals and humans (REBEC, UTN code: U1111-1276-1942) was investigated by repurposing Metformin, as a mean to manage periodontal disease and its associated systemic risk factors.ResultsWe found that glucose metabolism control via use of Metformin aimed at PD management resulted in significant prevention of bone loss during induced periodontal disease and age-related bone loss in vivo. Metformin also influenced the bacterial species present in the oral environment and impacted the metabolic epithelial and stromal responses to bacterial dysbiosis at a single cell level. Systemically, Metformin controlled blood glucose levels and age-related weight gain when used long-term. Translationally, our pilot randomized control trial indicated that systemic Metformin was safe to use in non-diabetic patients and affected the periodontal tissues. During the medication window, patients showed stable levels of systemic blood glucose, lower circulating hsCRP and lower insulin levels after periodontal treatment when compared to placebo. Finally, patients treated with Metformin had improved periodontal parameters when compared to placebo treated patients.ConclusionThis is the first study to demonstrate that systemic interventions using Metformin in non-diabetic individuals aimed at PD prevention have oral-systemic effects constituting a possible novel form of preventive medicine for oral-systemic disease management.

Povidone-iodine intra-abdominal irrigation versus no irrigation in pediatric perforated appendicitis: A secondary economic analysis of a Bayesian randomized controlled trial

BackgroundA pilot randomized controlled trial (RCT) conducted in children (2–17 ​y) with perforated appendicitis demonstrated an 89% probability of reduced intra-abdominal abscess (IAA) rate with povidone-iodine (PVI) irrigation, compared with no irrigation (NI). We hypothesized that PVI also reduced 30-day hospital costs. MethodsWe conducted a retrospective economic analysis of a pilot RCT. Hospital costs, inflated to 2019 U.S. dollars, were obtained for index admissions and 30-day emergency visits and readmissions. Cost differences between groups were assessed using frequentist and Bayesian generalized linear models. ResultsWe observed a 95% Bayesian probability that PVI reduced 30-day mean total hospital costs ($16,555 [PVI] versus $18,509 [NI]; Bayesian cost ratio: 0.90, 95% CrI, 0.78–1.03). The mean absolute difference per patient was $1,954 less with PVI (95% CI, -$4,288 to $379). ConclusionsPVI likely reduced the IAA rate and 30-day hospital costs, suggesting the intervention is both clinically superior and cost saving.

A qualitative study of the perceived benefits of participating in a spinal cord rehabilitation intervention in a low-middle income country

Purpose Improving quality of life (QoL) is a major goal of rehabilitation following spinal cord injury (SCI). However, people with disabilities in resource constrained contexts have limited access to rehabilitation and poorer health outcomes, including QoL. There is a paucity of qualitative research on the experiences of persons with SCI involved in rehabilitation programmes in low-middle income countries. This study aimed to assess participants’ perceptions of the benefits of a 24-week SCI rehabilitation programme delivered as part of a pilot randomized controlled trial (RCT) in South Africa. Materials and methods Sixteen participants, with chronic motor-incomplete tetraplegia, were enrolled in a two-arm pilot RCT involving robotic locomotor training, a novel technology, and standard activity-based training (Pan African Clinical Trial Registry (PACTR201608001647143)). Data were collected via in-depth interviews and analysed using thematic analysis. Results Participants described several improvements in QoL, including enhanced functional independence; reduced secondary complications; and improved psychosocial and emotional well-being. Conclusions The holistic approach to rehabilitation calls for the involvement of individuals’ views about what matters to them to inform clinical practice and to highlight the role that physical activity and the perceived successes play in shaping the lived experiences after SCI. Trial registration Pan African Clinical Trial Registry (PACTR201608001647143), registration date (21st May 2016), study start date (30th Nov 2016)https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1647

Exploring the feasibility of a cluster pilot randomised control trial to improve children’s 24-hour movement behaviours and dietary intake: Happy homework

ABSTRACT We aimed to explore the feasibility, acceptability, and potential efficacy of Happy Homework (HH); an 8-week home-focussed intervention, with the purpose of encouraging children’s positive dietary behaviours and engagement in positive physical activity (PA) and sleep behaviours. We randomised four Scottish schools (n = 71 participants; 5 classrooms) to either the HH intervention (n = 2) or usual curriculum control group (n = 2). HH consisted of movement and dietary-focused parent and child tasks. Primary outcome measures were intervention feasibility, acceptability, and potential efficacy. Secondary outcomes were objectively measured PA via ActiGraph GT3X+, sedentary behaviours (SBs) and sleep duration via activPAL4™ accelerometers and dietary behaviours, fruit and vegetable consumption and screen-time via questionnaires. After controlling for pre-test levels, post intervention stepping time and sleep duration were significantly greater for the HH group in comparison to the control group. The HH group reported eating more fruit and vegetables at post-test than the control group. Participants also reported the intervention to be enjoyable and motivating. These findings provide promising evidence that given a greater sample size, better retention and the prioritisation of health and wellbeing homework, HH could enhance children’s health and wellbeing.

High flow nasal oxygen versus usual care in improving pulmonary rehabilitation outcomes of chronic obstructive pulmonary disease patients after an exacerbation - a pilot randomized controlled trial

Introduction Early pulmonary rehabilitation (PR) is guideline-recommended for all chronic obstructive pulmonary disease (COPD) patients post-hospitalization for COPD exacerbation but many patients experience difficulties participating in early PR due to significant breathlessness. High flow nasal oxygen (HFO) has been shown to improve ventilatory efficiency in stable COPD patients, but there is little data on HFO use during exercise training in PR post-COPD exacerbation. Methods We conducted a pilot randomized controlled trial (RCT) to explore the feasibility of a prospective large-scale RCT to evaluate the impact of HFO in improving PR outcomes of COPD patients post-exacerbation. Patients recently hospitalized for COPD exacerbation were enrolled and randomized to either HFO or usual care during an early 6-weeks, outpatient PR program. Results Twenty two patients were randomized between May 2019 to Dec 2019 and 18 patients completed the study. The HFO arm achieved a greater improvement in exercise capacity than the usual care arm, with the mean difference in 6-min walk distance (6MWD) being 30 m (95% CI: −23 m to 84 m), although this was not statistically significant. All 18 patients in both arms were compliant to the pulmonary rehabilitation program (defined by attending ≥75% of exercise sessions). HFO was well tolerated with no adverse events reported. Conclusion This pilot RCT has shown preliminary evidence of the feasibility and high patient acceptability of HFO during early PR on improving exercise capacity in COPD patients post-exacerbation These promising results would justify a larger RCT to confirm HFO’s benefits and has the potential to change PR practice.

The development and initial feasibility testing of D-HOMES: a behavioral activation-based intervention for diabetes medication adherence and psychological wellness among people experiencing homelessness.

Compared to stably housed peers, people experiencing homelessness (PEH) have lower rates of ideal glycemic control, and experience premature morbidity and mortality. High rates of behavioral health comorbidities and trauma add to access barriers driving poor outcomes. Limited evidence guides behavioral approaches to support the needs of PEH with diabetes. Lay coaching models can improve care for low-resource populations with diabetes, yet we found no evidence of programs specifically tailored to the needs of PEH. We used a multistep, iterative process following the ORBIT model to develop the Diabetes Homeless Medication Support (D-HOMES) program, a new lifestyle intervention for PEH with type 2 diabetes. We built a community-engaged research team who participated in all of the following steps of treatment development: (1) initial treatment conceptualization drawing from evidence-based programs, (2) qualitative interviews with affected people and multi-disciplinary housing and healthcare providers, and (3) an open trial of D-HOMES to evaluate acceptability (Client Satisfaction Questionnaire, exit interview) and treatment engagement (completion rate of up to 10 offered coaching sessions). In step (1), the D-HOMES treatment manual drew from existing behavioral activation and lay health coach programs for diabetes as well as clinical resources from Health Care for the Homeless. Step (2) qualitative interviews (n = 26 patients, n = 21 providers) shaped counseling approaches, language and choices regarding interventionists, tools, and resources. PTSD symptoms were reported in 69% of patients. Step (3) trial participants (N = 10) overall found the program acceptable, however, we saw better program satisfaction and treatment engagement among more stably housed people. We developed adapted treatment materials for the target population and refined recruitment/retention strategies and trial procedures sensitive to prevalent discrimination and racism to better retain people of color and those with less stable housing. The research team has used these findings to inform an NIH-funded randomized control pilot trial. We found synergy between community-engaged research and the ORBIT model of behavioral treatment development to develop a new intervention designed for PEH with type 2 diabetes and address health equity gaps in people who have experienced trauma. We conclude that more work and different approaches are needed to address the needs of participants with the least stable housing.

Long-Term Outcomes of a Comprehensive Mobile Smoking Cessation Program With Nicotine Replacement Therapy in Adult Smokers: Pilot Randomized Controlled Trial.

Increased smartphone ownership has led to the development of mobile smoking cessation programs. Although the related body of evidence, gathered through the conduct of randomized controlled trials (RCTs), has grown in quality and rigor, there is a need for longer-term data to assess associated smoking cessation durability. The primary aim was to compare smoking cessation outcomes at 52 weeks in adult smokers randomized to a mobile smoking cessation program, Pivot (intervention), versus QuitGuide (control). The secondary aims included comparison of other smoking-related behaviors, outcomes and participant feedback, and exploratory analyses of baseline factors associated with smoking cessation. In this remote pilot RCT, cigarette smokers in the United States were recruited on the web. Participants were offered 12 weeks of free nicotine replacement therapy (NRT). Data were self-reported via a web-based questionnaire with videoconference biovalidation in participants who reported 7-day point-prevalence abstinence (PPA). Outcomes focused on cessation rates with additional assessment of quit attempts, cigarettes per day (CPD), self-efficacy via the Smoking Abstinence Self-Efficacy Questionnaire, NRT use, and participant feedback. Cessation outcomes included self-reported 7- and 30-day PPA, abstinence from all tobacco products, and continuous abstinence. PPA and continuous abstinence were biovalidated using witnessed breath carbon monoxide samples. Exploratory post hoc regression analyses were performed to identify baseline variables associated with smoking cessation. Participants comprised 188 smokers (n=94, 50% in the Pivot group and n=94, 50% in the QuitGuide group; mean age 46.4, SD 9.2 years; n=104, 55.3% women; n=128, 68.1% White individuals; mean CPD 17.6, SD 9.0). Several cessation rates were higher in the Pivot group (intention to treat): self-reported continuous abstinence was 20% (19/94) versus 9% (8/94; P=.03) for QuitGuide, biochemically confirmed abstinence was 31% (29/94) versus 18% (17/94; P=.04) for QuitGuide, and biochemically confirmed continuous abstinence was 19% (18/94) versus 9% (8/94; P=.046) for QuitGuide. More Pivot participants (93/94, 99% vs 80/94, 85% in the QuitGuide group; P<.001) placed NRT orders (mean 3.3, SD 2.0 vs 1.8, SD 1.6 for QuitGuide; P<.001). Pivot participants had increased self-efficacy via the Smoking Abstinence Self-Efficacy Questionnaire (mean point increase 3.2, SD 7.8, P<.001 vs 1.0, SD 8.5, P=.26 for QuitGuide). QuitGuide participants made more mean quit attempts (7.0, SD 6.3 for Pivot vs 9.5, SD 7.5 for QuitGuide; P=.01). Among those who did not achieve abstinence, QuitGuide participants reported greater CPD reduction (mean -34.6%, SD 35.5% for Pivot vs -46.1%, SD 32.3% for QuitGuide; P=.04). Among those who reported abstinence, 90% (35/39) of Pivot participants and 90% (26/29) of QuitGuide participants indicated that their cessation program helped them quit. This pilot RCT supports the long-term effectiveness of the Pivot mobile smoking cessation program, with abstinence rates durable to 52 weeks. ClinicalTrials.gov NCT04955639; https://clinicaltrials.gov/ct2/show/NCT04955639.

Impact of Tailored-Enhanced Recovery After Surgery Versus Conventional Care in Patients of Gastro-Duodenal Perforation: A Pilot Randomized Control Trial.

The enhanced recovery after surgery (ERAS) program established improved clinical outcomes in elective surgery; however, its role in emergencies is uncertain. This study was designed to assess the feasibility, safety, and efficacy of a tailored-ERAS (t-ERAS) protocol in patients undergoing modified Graham's patch closure for gastro-duodenal perforation. A single-centre, prospective, parallel-arm, open-label, randomized controlled trial was conducted from February 2021 to December 2021. Patients with gastroduodenal perforation undergoing modified Graham's patch were randomly assigned to either conventional care or the t-ERAS pathway. Patients with refractory septic shock, psychiatric or neurological disorders, pregnancy, multiple perforations, sealed-off perforations, and perforation sizes greater than 1.5 cm were excluded. The primary outcome was to compare the length of hospitalization (LOH). Functional recovery parameters and morbidity were compared in secondary outcomes. Twenty-five patients each were included in conventional care and the t-ERAS group. In the t-ERAS group, LOH was significantly shorter (6.3 SD2.15 days versus 9.56 SD4.33 days, p = 0.001). Patients in the t-ERAS group had significantly early functional recovery (days) with time to first bowel sound (1.8 SD0.41; p 0.002), first flatus (2.52 SD0.65; p = 0.026), first stool (3.04 SD0.68; p < 0.001), first liquid diet (2.24 SD0.60; p = 0.002), and duration of ileus (2.64 SD0.86; p = 0.038). There was no significant difference in morbidity such as post-operative nausea and vomiting, SSI, or pulmonary complications between the two groups. Tailored ERAS pathways are safe and effective in reducing the LOH and promoting early functional recovery in patients undergoing emergency closure of gastro-duodenal perforation.

Effects of pole dance on mental wellbeing and the sexual self-concept—a pilot randomized-controlled trial

BackgroundPrior studies on beneficial effects of dance have primarily focused on traditional and expressionistic dance forms, neglecting newer dance styles like pole dance, which employ distinct techniques. The present pilot randomized controlled trial examined psychological and psychosexual effects of pole dancing.MethodsFifty women were randomized to an eight-weeks pole dancing program or waitlist. The primary outcome was global mental wellbeing. Secondary outcomes included several dimensions of the sexual self-concept, as well as body appreciation and global self-esteem.ResultsCompared to waitlist, the pole dance group showed an increase in mental wellbeing and improvements in sexual self-efficacy, sexual anxiety, sexual self-esteem, and body appreciation.ConclusionsPole dancing may have broad psychological effects on both overall mental wellbeing and important domains of the sexual self-concept.

Effects of digital-based physical activity intervention on pain, function and adherence in individuals with knee osteoarthritis: a pilot randomized-controlled trial

Effects of digital-based physical activity intervention on pain, function and adherence in individuals with knee osteoarthritis: a pilot randomized-controlled trial

Controlling peripheral intravenous catheter failure by needleless connector design: A pilot randomised controlledtrial.

To test the feasibility of a study protocol that compared the efficacy of neutral- and negative-pressure needleless connectors (NCs). A single-centre, parallel-group, pilot randomised control trial. Our study compared neutral-(intervention) and negative-pressure (control) NCs among adult patients in an Australian hospital. The primary feasibility outcome was measured against predetermined criteria (e.g. eligibility, attrition). The primary efficacy outcome was all-cause peripheral intravenous catheter failure, analysed as time-to-event data. In total, 201 (100 control; 101 intervention) participants were enrolled between March 2020 and September 2020. All feasibility criteria were met except eligibility, which was lower (78%) than the 90% criterion. All-cause peripheral intravenous catheter failure was significantly higher in the intervention group (39%) compared to control (19%). With minor modifications to participant screening for eligibility, this randomised control trial is feasible for a large multicentre randomised control trial. The neutral NC was associated with an increased risk of peripheral intravenous catheter failure. There are several NC designs available, often identified by their mechanism of pressure (positive, negative and neutral). However, NCs can contribute to peripheral intravenous catheter failure. This is the first randomised controlled trial to compare neutral and negative NC designs. Negative pressure NCs had lower PIVC failure compared to neutral NCs, however the results might not be generalisable to other brands or treatment settings. Further high-quality research is needed to explore NC design. Study methods and results reported in adherence to the CONSORT Statement. No patient or public contribution.

Pain Informed Movement for people with knee osteoarthritis: Protocol for a pilot randomized controlled trial

ObjectiveConservative pain management strategies for knee osteoarthritis (KOA) have limited effectiveness and do not employ a pain-mechanism informed approach. Pain Informed Movement is a novel intervention combining mind-body techniques with neuromuscular exercise and pain neuroscience education (PNE), aimed at improving endogenous pain modulation. While the feasibility and acceptability of this program has been previously established, it now requires further evaluation in comparison to standard KOA care. DesignThis protocol describes the design of a pilot two-arm randomized controlled trial (RCT) with an embedded qualitative component. The primary outcome is complete follow-up rate. With an allocation ratio of 1:1, 66 participants (33/arm) (age ≥40 years, KOA diagnosis or meeting KOA NICE criteria, and pain intensity ≥3/10), will be randomly allocated to two groups that will both receive 8 weeks of twice weekly in-person exercise sessions. Those randomized to Pain Informed Movement will receive PNE and mind-body technique instruction provided initially as videos and integrated into exercise sessions. The control arm will receive neuromuscular exercise and standard OA education. Assessment will include clinical questionnaires, physical and psychophysical tests, and blood draws at baseline and program completion. Secondary outcomes are program acceptability, burden, rate of recruitment, compliance and adherence, and adverse events. Participants will be invited to an online focus group at program completion. ConclusionThe results of this pilot RCT will serve as the basis for a larger multi-site RCT aimed at determining the program's effectiveness with the primary outcome of assessing the mediating effects of descending modulation on changes in pain.

Multi-disciplinary community-based group intervention for fibromyalgia: a pilot randomized controlled trial.

Fibromyalgia is characterized by widespread pain, fatigue, sleep disturbances, mood disturbances, and cognitive impairment. Most individuals with fibromyalgia experience poorly managed symptoms and increased healthcare service use. Multicomponent therapies, with a focus on nonpharmacological modalities, are increasingly supported in the literature. However, given the limited resources available, implementation in smaller communities remains a challenge. This research tested a community-based multidisciplinary group intervention for individuals diagnosed with FM living in a small urban centre. The primary outcome was perceptions of quality of care and secondary outcomes included disease-related functioning, anxious and depressive symptoms, pain beliefs, and health service utilization. A pilot randomized control trial was conducted in which 60 patients diagnosed with fibromyalgia were randomized into a 10-week community-based multidisciplinary group intervention program or usual care. Treatment components included twice-weekly exercise sessions and weekly education sessions (e.g., pain education, cognitive behavioral strategies for stress, nutrition, peer support). The trial (NCT03270449) was registered September 1 2017. Statistically significant post-intervention improvements were found in the primary outcome, perceived quality of care (Cohen's d = 0.61, 0.66 for follow up care and goal setting, respectively). Secondary outcomes showing statistically significant improvements were disease-related daily functioning (Cohen's d = 0.70), depressive symptoms (Cohen's d = 0.87), and pain beliefs (Cohen's d = 0.61, 0.67, 0.82 for harm, disability and control, respectively). No adverse events were reported. Community-based multidisciplinary group interventions for fibromyalgia show promise for improving satisfaction with quality of care, disease-related functioning, and depression, and fostering more adaptive pain beliefs.

Feasibility and Effectiveness of Speech Intervention Implemented with a Virtual Reality System in Children with Developmental Language Disorders: A Pilot Randomized Control Trial.

Language disorders are characterized by impairments in verbal expression/understanding, including difficulties with one or more language components. The Virtual Reality Rehabilitation System (VRRS) is a bioelectromedical device equipped with exercise sections aimed at improving cognitive and language deficits. It also increases patient motivation and engagement. The aim of our study was to test the feasibility and efficacy of VRRS intervention to improve speech therapy treatment for children with speech disorders. Thirty-two patients were enrolled in this study and randomly assigned to the experimental (EG) or control group (CG). The CG underwent conventional speech therapy, while EG underwent VRRS-implemented speech therapy. Both groups were evaluated before (T0) and after (T1) the intervention using the Language Assessment Test. The results showed improvements in both groups. However, the EG group showed greater improvement in various areas, including comprehension of total words, repetition, naming of body parts, naming of everyday objects, total naming, morphosyntactic accuracy, sentence construction, average length of utterance, and spontaneous word production. This study demonstrated that VRRS can be a valuable tool for implementing effective speech rehabilitation. Further studies are needed, as the use of VRRS is still in its early stages, requiring larger samples sizes and long-term follow-up.

Computer-assisted intraoperative 3D-navigation for liver surgery: a prospective randomized-controlled pilot study.

Liver surgery is the standard of care for primary and many secondary liver tumors. Due to variability and complexity in liver anatomy preoperative imaging is necessary to determine resectability and for planning the surgical strategy. In the last few years, computer-assisted resection planning has been introduced in liver surgery. Aim of this trial was the evaluation of computer-assisted three-dimensional (3D)-navigation for liver surgery. This study was a prospective randomized-controlled pilot trial and patients were randomized in navigated or non-navigated group. Primary end point was the quotient of intraoperative resected volume and planned resection volume. Secondary end points included operation time, resection margin and postoperative complications. 3D reconstructions were performed with MeVis Distant Services (MeVis AG, Bremen, Germany). The navigation system CAS-One Liver (CAScination AG, Bern, Switzerland) was used for intraoperative computer-assisted 3D-navigation. The data of 16 patients with 20 liver tumors were used in this analysis. Of these, 8 liver tumors were resected with the utilization of intraoperative navigation. Two postoperative complications were classified grade IIIa or higher. There was no difference in duration of operation (189 vs. 180 min, P=0.970), rate of postoperative complications (n=1 vs. n=1, P=0.696) and length of hospital stay (9 vs. 7 days, P=0.368) between the two groups. Minimal resection margin (0.15 vs. 0.40 cm, P=0.384) and quotient of planned to intraoperative resection volume (0.94 vs. 1.11, P=0.305) were also similar. Intraoperative navigation is a technology that can be safely used during liver resection. Surgical accuracy is not yet superior to the current standard of intraoperative orientation. Further technological advances with suitable deformation algorithms and augmented reality systems will enable a further improvement of the technical feasibility.

Pilot Randomized, Double-Blind, Placebo-Controlled Crossover Trial Evaluating the Feasibility of an Intranasal Oxytocin in Improving Social Cognition in Individuals Living with Alzheimer's Disease.

Individuals living with Alzheimer's disease (AD) demonstrate extensive deficits in social cognition. To date, no studies have investigated the feasibility of an intranasal oxytocin (INOT) treatment to improve social cognition in individuals living with AD. We conducted a pilot trial to determine recruitment feasibility, enrolment acceptability, and adherence to an INOT treatment to inform on the subsequent design of a future randomized controlled trial (RCT). We also estimated the effect sizes of potential social cognitive function outcome measures related to participants and their caregivers. Four individuals with AD were enrolled in a single-center, randomized, double-blind, placebo-controlled crossover trial involving a one-week treatment period with both INOT (72 IU twice daily) and placebo. All participants reported no treatment-causative or serious adverse events following repeated INOT administration. While enrolment acceptability (100%) and INOT adherence (placebo, 95%; INOT, 98%) were excellent, feasibility of recruitment was not acceptable (i.e., n = 4/58 individuals screened met inclusion criteria). However, positive/large effects were associated with secondary outcomes of self-reported health and wellbeing, caregiver 'burden', intimacy and interpersonal-bonding, following repeated INOT administration. No positive effects were associated with participant outcomes of social cognition. This pilot RCT provides first evidence that INOT administration in individuals living with AD is safe and well-tolerated. Despite limitations in sample size, moderate-to-large effect size improvements were identified in participant health outcomes as well as core social cognitive functions and 'burden' as reported by a caregiver. This suggests potential broad-ranging beneficial effects of INOT which should be assessed in future RCTs.