Health interventions should be designed to be appropriate for scaling from the outset, but the extent to which factors that are important for scalability are reported on in pilot randomised trials is unclear. This review assesses the extent to which pilot randomised trials report on 15 domains of intervention scalability. Methodological review. Four journals were searched: BMJ Open, BMC Pilot and Feasibility Studies, BMC Trials and PLoS One for articles published between January 2023 and October 2024. We included pilot randomised trials of health interventions. Data relevant to 15 scalability domains, derived from the Intervention Scalability Assessment Tool and wider implementation science literature, were extracted. Data were double-extracted for 20% of the included studies. Two authors scored all studies from 0 to 3 (0=Not at all; 1=Small extent; 2=Moderate extent; 3=Large extent) on the extent to which each of the 15 scalability domains was reported. For each scalability domain, we calculated the mean score and the frequency of each categorical score across the included studies. Titles and abstracts screening (521 publications) resulted in 132 full-text publications for review. Of the 104 eligible studies, a random sample of 50 studies were selected for detailed review. Through snowballing, an additional 49 associated publications were identified (eg, protocols), resulting in 99 publications across 50 studies. Most studies reported the Problem (30/50, 60%; mean=2.4 ± 0.8) and the Intervention (37/50, 74%; mean=2.7 ± 0.4) to a large extent (ie, scored 3), with the Delivery Setting and Workforce domain most often receiving a score of 2 (28/50, 56%; mean=2.2 ± 0.7). For eight of the scalability domains, the majority of studies scored 0. The extent of scalability domain reporting in pilot trials of health interventions is limited. Explicit consideration of scalability in pilot trials could improve the design of fully powered randomised controlled trials and enhance the potential for effective interventions to be translated into practice. Future research should consider if and how to incorporate scalability considerations into pilot trials, and whether pilot trial and intervention reporting guidelines should be expanded to include scalability considerations.
Feline chronic gingivostomatitis (FCGS) is characterized by persistent oral inflammation, leading to severe pain, hyporexia, weight loss, and reduced well-being. Affected cats exhibit altered levels of inflammatory mediators; however, most diagnostic procedures require administration of anesthesia, highlighting the need for alternative monitoring approaches. This prospective exploratory pilot study aimed to compare two simple and rapid saliva collection methods-pipetting and absorbent paper points-used for assessing prostaglandin E2 (PGE2) and interleukin-6 (IL-6) levels in cats. Saliva samples were obtained from 86 cats that were initially evaluated and classified into three groups: FCGS (n=22), other oral inflammatory conditions (OOIC) (n=27), and controls without oral inflammation (n=37); 25 of the control animals were subsequently excluded from the analysis. Compared with pipetting, absorbent paper points were better tolerated by cats with oral inflammation. In the samples collected by pipetting, the mean IL-6 concentration was higher in the FCGS group (473.10 pg/mL) than in the control group (12.78 pg/mL). A similar pattern was observed in samples collected using absorbent paper points; IL-6 levels were highest in the FCGS group (170.90 pg/mL), followed by the OOIC (6.05 pg/mL) and control (1.50 pg/mL) groups. PGE2 levels were also highest in the FCGS group (647.52 pg/mL), followed by the control group (182.13 pg/mL) and the OOIC group (111.40 pg/mL). These findings should be interpreted in light of the pilot design, sample exclusions, and absence of a diagnostic reference standard. Nonetheless, salivary assessment appears to be a feasible and promising noninvasive approach for monitoring oral inflammation in cats with FCGS. A gengivoestomatite crônica felina (Feline Chronic Gingivostomatitis – FCGS) é caracterizada por inflamação oral persistente, resultando em dor intensa, hyporexia, perda de peso e redução do bem-estar. Gatos acometidos apresentam alterações em mediadores inflamatórios; entretanto, a maioria dos procedimentos diagnósticos requer anestesia, o que evidencia a necessidade de abordagens alternativas para monitoramento da doença. Este estudo prospectivo, piloto e exploratório teve como objetivo comparar dois métodos simples e rápidos de coleta de saliva — pipetagem e pontas de papel absorventes — para a avaliação dos níveis de prostaglandina E2 (PGE2) e interleucina-6 (IL-6) em gatos. Amostras de saliva foram obtidas de 86 gatos inicialmente avaliados e classificadas em três grupos: FCGS (n=22), outras condições inflamatórias orais (Other Oral Inflammatory Conditions – OOIC; n=27) e controles sem inflamação oral (n=37), dos quais 25 animais controle foram posteriormente excluídos da análise. As pontas de papel absorventes foram melhor toleradas por gatos com inflamação oral. Nas amostras coletadas por pipetagem, os níveis de IL-6 foram mais elevados no grupo FCGS (média de 473,10 pg/mL) em comparação aos controles (12,78 pg/mL). Padrão semelhante foi observado nas amostras coletadas com pontas de papel absorventes, com maiores níveis de IL-6 no grupo FCGS (170,90 pg/mL), seguido por OOIC (6,05 pg/mL) e controles (1,50 pg/mL). Os níveis de PGE2 também foram mais elevados no grupo FCGS (647,52 pg/mL), seguidos pelos controles (182,13 pg/mL) e pelo grupo OOIC (111,40 pg/mL). Esses achados devem ser interpretados à luz do delineamento piloto do estudo, das exclusões amostrais e da ausência de um padrão diagnóstico de referência aplicado de forma uniforme. Ainda assim, a avaliação salivar demonstra ser uma abordagem não invasiva, viável e promissora para o monitoramento da inflamação oral em gatos com FCGS.
REDE D+, a social prescribing (SP) program, offers a complementary approach to traditional T2DM management by connecting people to community activities designed to support them in self-care behaviors and health literacy (HL). This study aims to assess the feasibility of a pilot study by evaluating recruitment, adherence and retention rates among people with T2DM, health professionals (nurses), community stakeholders, while exploring preliminary results in improvements on self-care behaviors and HL. This 12-week non-randomized pilot cohort study, conducted in primary and community healthcare settings in accordance with the guidelines of the Medical Research Council, involved a personalized assessment during a diabetes nursing consultation, followed by the prescription of community-based activities. Subsequently, a social prescriber nurse acts as a liaison between the two settings through structured follow-up, ensuring the continuity of the prescribed community-based activities. Primary outcomes were feasibility (recruitment, adherence, and retention rates). The secondary outcomes included anthropometric values [weight, body mass index (BMI), and abdominal perimeter], clinical values [glycated hemoglobin A1c (HbA1c)], measures of self-care, HL, diabetes knowledge, quality of life, and wellbeing. Descriptive and exploratory inferential analyses were conducted to examine preliminary patterns. Magnitude of effect was estimated via Cohen's d, allowing for a standardized assessment of improvements across the secondary outcomes. The REDE D+ program revealed an 87.8% recruitment rate across the three participant groups, a 90% retention rate, and a good level of adherence to group community-based activities (94.4%). The secondary results suggest a small effect size of the SP intervention on weight, BMI, abdominal circumference, and HbA1c, and some improvements in HL and self-care behavior with a medium effect. The indicators related to physical activity and quality of life were the domains that showed the most statistically significant effects. The REDE D+ program has proven to be feasible, yielding positive results in terms of recruitment, retention, and adherence among people with T2DM. Preliminary secondary results suggest that has the potential to support the improvement of self-care behaviors and promote HL. However, future research is needed to evaluate its effectiveness and cost-effectiveness in large-scale studies.
Ticks are major ectoparasites and vectors of pathogens affecting humans, livestock, and wildlife. They harbor diverse microbial communities that may influence tick biology and interactions with microorganisms; however, functional information on tick-associated microbiomes remains limited, particularly in North Africa. In this pilot study, we applied a metaproteomic approach based on high-resolution tandem mass spectrometry to characterize bacterial communities associated with three tick species collected in Algeria: Rhipicephalus sanguineus sensu lato, Hyalomma aegyptium, and Hyalomma dromedarii. Peptide spectra were assigned to taxa using a two-step database search strategy based on NCBInr, and bacterial composition and relative abundance were compared across tick species and sampling locations. A total of 40 bacterial genera belonging to 32 families and four phyla were identified. Microbiome composition differed significantly between tick genera and collection locations, suggesting an influence of species-specific and geographical factors on microbial community structure. Dominant genera included Streptomyces, Bacillus, Clostridium, Escherichia, Flavobacterium, Paenibacillus, and Providencia. Peptides related to Coxiella spp. were frequently detected, consistent with previous reports of Coxiella-like endosymbionts in ticks. This pilot study provides a first metaproteomic characterization of tick-associated communities in Algeria. The results reveal species- and location-associated differences in microbial composition and highlight the potential of metaproteomics for exploring tick-associated microbiomes in North Africa.
To assess uptake of nirsevimab, a long-acting monoclonal antibody for respiratory syncytial virus (RSV) prevention, during the first season of Ireland's Pathfinder pilot universal newborn immunisation programme and to identify socio-demographic and perinatal predictors of uptake. Cross-sectional analysis of routinely collected programme data. Ireland's Mid-West region, served by University Maternity Hospital Limerick, the sole maternity and neonatal hospital for the region. Infants born 1 September 2024 to 28 February 2025. Uptake of nirsevimab before hospital discharge. Overall uptake was 89.4% (1600/1790) and did not vary by month (p=0.119); it was similar by sex (male 89.5%, female 89.2%; p=0.838). Preterm infants had higher uptake than term (96.9% vs 88.7%; p=0.001), and those admitted to the neonatal unit also had higher uptake (93.0% vs 88.4%; p=0.009). In adjusted analyses, maternal age (adjusted OR (aOR) 1.06 per year, 95% CI 1.03 to 1.09, p<0.001) and preterm birth (aOR 3.08 (95% CI 1.14 to 8.37), p=0.027) were associated with uptake. Uptake varied by maternal ethnicity: 91.5% in white Irish, 53.6% in Irish Traveller (aOR 0.13 (95% CI 0.08 to 0.23)), 79.7% in other white background (aOR 0.39 (95% CI 0.24 to 0.61)), 90.0% in black or black Irish, 98.3% in Asian or Asian Irish and 84.2% in other/mixed or prefer not to say. Although uptake among white Irish was high, they accounted for the largest absolute number of infants who did not receive nirsevimab, reflecting their predominance in the birth cohort. During the first season of Ireland's Pathfinder RSV pilot programme in the Mid-West region, nearly 90% of newborns received nirsevimab before discharge. Uptake was consistently high across months, indicating effective implementation but lower among infants of Irish Traveller and other white background mothers, highlighting the need for targeted, culturally adaptable equity strategies within a high-uptake programme. These findings may inform national and international policies and offer practical lessons for universal RSV immunisation.
Although technology has been widely implemented in Parkinson's disease (PD) research, little is known about its efficacy on participants' psychosocial domains. This study assessed the potential effect and usability of the Voice-Activated Intelligent Personal Assistant (VIPA) on participants' sense of coherence and psychosocial well-being. This single-blinded, 2-arm pilot randomised controlled trial, with 7 post-intervention interviews, recruited 48 participants. Intervention group participants received a user protocol for their 8-week VIPA usage, while the control group received usual care. Primary outcome was the Sense of Coherence 13-item scale (SOC-13). Other outcomes were Mental Health Continuum-Short Form (MHC-SF), UCLA Three-Item Loneliness Scale, Parkinson's Disease Questionnaire-8, Brief Resilient Coping Scale, and System Usability Scale. Generalized Estimating Equation (GEE) was selected as the primary analysis, with multiple imputation performed as sensitivity analysis. A significant reduction of positive emotion in IG was identified for the MHC-SF emotional well-being at post-intervention (β = -1.69, p = 0.028) but not at week 12 follow-up (β = -0.96, p = 0.31). Exploratory effect sizes were identified for SOC-13 meaningfulness (d = 0.27), manageability (d = 0.19), and MHC-SF psychological well-being (d = 0.27). Interviewee reportedly internalised their failed interaction attempts into speech characteristics, and it resembled being ignored by a real person. The study identified preliminary trends of improvements in participants' meaningfulness domain and psychological well-being. The decrease in emotional well-being could be attributed to the reported technical difficulties and VIPA's fair usability. A future VIPA redesign is required to avoid similar adverse effects.
Reduced or lost sensation and movement after a spinal cord injury (SCI) impairs the brain's ability to accurately localize paralyzed body parts, causing deficits in its internal body map, or "mental body representations" (MBR). These deficits hinder functional recovery and contribute to neuropathic pain. Medications for neuropathic pain are often ineffective and carry side-effects. Our pilot trials found that in-person Cognitive Multisensory Rehabilitation (CMR), a physical therapy restoring MBR, led to prolonged pain reduction, improved sensorimotor function, and enhanced brain function, to greater extent than adaptive fitness. To explore more accessible interventions for those in rural areas or with transportation challenges, we examined whether 12 weeks of remotely delivered CMR or exercise would (1) improve function and reduce pain; (2) increase brain activity and connectivity related to sensorimotor function and MBR in adults with SCI. Of 19 adults with SCI who consented, 15 (51±15 years old, 8±10 years post-SCI) were randomized to 12 weeks of remotely delivered CMR or exercise (45min, 3x/week). Eight reported neuropathic pain ≥3/10. The Numeric Pain Rating Scale (NPRS), ASIA Impairment Scale (AIS), and Neuromuscular Recovery Scale (NRS) assessed pain and sensorimotor function at baseline, post-intervention, and 6-month follow-up. Functional MRI included resting-state and four tasks: imagining feeling the left leg, imagining moving the left leg, whole-body movement imagery, and a sensation task. After CMR (n=8), participants improved on AIS (large effect sizes: touch: d=1.30; pinprick: d=1.21; lower limb motor function: d=1.83). Exercise (n=7) produced smaller improvements (touch: d=0.35; pinprick: d=0.36; lower limb motor function: d=0.80). CMR showed greater NRS effect sizes (core: d=1.48; upper limb: d=0.69; lower limb: d=1.25) than exercise (core: d=0.31; upper limb: d=0.74; lower limb: d=0.83). Benefits persisted at follow-up for both AIS and NRS, especially in the CMR group. Highest neuropathic pain intensity decreased in both groups post-intervention (CMR: d=-0.61; exercise: d=-0.73) and at 6-month follow-up (CMR: d=-0.55; exercise: d=-0.55). Unlike previous studies, group effects for CMR were not found due to high heterogeneity. Increased task-based activation, including in the lateral occipital cortex involved in visual body perception and spatial awareness, was seen for the exercise group (n=5). These preliminary results support the potential of remotely delivered CMR and exercise to improve function and reduce neuropathic pain in adults with SCI, highlighting the need for larger trials. Clinicaltrial.gov: NCT05870189.
Respiratory muscle weakness is common after cardiac surgery and may impair recovery. Although respiratory muscle training has demonstrated benefits, evidence during phase II cardiac rehabilitation remains limited, and many available devices are unidirectional and costly. TriBURTER® is a device that enables bidirectional respiratory muscle training. To evaluate the feasibility, safety, and explore the potential effect of the TriBURTER® device compared with flow incentive spirometry in patients undergoing phase II cardiac rehabilitation after cardiac surgery. This was a pilot, randomized, open-label, parallel study. Adults who had undergone cardiac surgery via sternotomy were included. Participants were assigned to training with TriBURTER® or flow incentive spirometry for 4 weeks. The primary outcome was respiratory muscle strength assessed by maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP). Secondary outcomes included pulmonary function (FEV1, FVC), functional capacity assessed by the six-minute walk test (6MWT), and quality of life (SF-36). Thirty patients were randomized (mean age 61.7±9.4 years; 13.3% women). No between-group differences in MIP or MEP were observed in the overall analysis. In exploratory subgroup analyses, patients with baseline respiratory muscle weakness showed greater increases in MIP (-68 to -93cmH2O) and MEP (93 to 116cmH2O) in the TriBURTER® group. In intragroup analyses, 6MWT distance increased; however, no between-group differences were observed after adjustment. No adverse events were reported. In this pilot study, TriBURTER® was safe and feasible to implement. The findings suggest a potential effect on respiratory muscle strength in exploratory analyses, particularly in patients with baseline weakness; these results require confirmation in larger, adequately powered trials.
Social support and social connectedness are key components of social health in later life, with reduced support linked to loneliness, social isolation, and adverse health outcomes. These challenges are intensified in remote and offshore communities, where geographic barriers limit social interaction and service access. In Ireland, nearly one in three adults over 50 experience emotional loneliness. While ICT-based interventions show promise, evidence for scalable, context-appropriate solutions remains limited. This study examines the feasibility and acceptability of a user-centred home telepresence approach in remote Irish settings. This nested case study, reported using the CASET framework, piloted a home telepresence intervention with older adults living alone in remote Irish communities. Following baseline surveys on expectations and preferences, participants engaged in scheduled video interactions. Post-intervention interviews assessed usability and general experience. The telepresence intervention was readily adopted by older adults, demonstrating high usability and accessibility. However, tensions emerged between automation and user control, alongside evolving privacy concerns. Engagement was strongest when supporting shared activities beyond conversation. Participant feedback highlighted the need for greater flexibility, improved controls, and enhanced on boarding to support sustained use. This case study demonstrates the feasibility of home telepresence as a rapid-deployment approach to support social connection among older adults in remote settings. Findings highlight the importance of usability, autonomy, privacy, and relational engagement for acceptability. Implementation Mapping supported structured, iterative development, informing future research, practice, and policy to enable sustainable, context-sensitive scale-up in rural and island communities.
Growing evidence suggests a potential role of the gut microbiota in pituitary neuroendocrine tumors (PitNETs). This exploratory study focused on prolactinoma, the most prevalent PitNET subtype, to preliminarily characterize gut microbial and metabolic features associated with the disease. Fecal samples were collected from five patients with hyperprolactinemic prolactinoma and five patients with nonfunctioning (NF) PitNETs. Exploratory metagenomic and metabolomic analyses were performed to profile gut microbiota composition and metabolic alterations. Compared with NF PitNET controls, prolactinoma patients showed distinct trends in gut microbial composition, including increased abundances of Bacteroides and Eubacterium and decreased abundances of Blautia and Clostridium. Metabolomic profiling identified differential metabolic features, including elevated fatty acid esters of hydroxy fatty acids (FAHFAs) and palmitoleic acid, which were mainly associated with glucose and lipid metabolism pathways. This pilot multi-omics analysis provides preliminary evidence of altered gut microbiome-metabolite profiles in prolactinoma. These findings are hypothesis-generating and may support further investigation of gut-pituitary axis interactions in larger, well-powered cohorts.
This pragmatic pilot study explored the potential effectiveness of a hybrid intervention combining transcutaneous auricular vagus nerve stimulation (taVNS) with slow breathing and assessed its feasibility, adherence, and acceptability among individuals with post-traumatic stress disorder (PTSD) symptoms related to the war in Ukraine. A delayed treatment within-subject design was used with five monthly assessments: one month before the intervention, pre- and postintervention (including physiologicdata), and two follow-ups with self-reported outcomes only. A total of 20 Ukrainian women (aged 18-49 years) with PTSD symptoms (PTSD checklist for DSM-5 [PCL-5] ≥31) practiced slow breathing paced by taVNS at 0.1 Hz (4-s inspiration and 6-s expiration with stimulation), twice daily for four weeks. Self-reported outcomes included PTSD symptoms (PCL-5), psychologic distress (Hopkins Symptom Checklist-25), well-being (World Health Organization-Five Well-Being Index), insomnia (Insomnia Severity Index), and somatic symptoms (Patient Health Questionnaire-15). Physiologic measures: heart rate, respiratory heart rate variability (respHRV), end-tidal CO2, and respiratory rate were collected at rest and during paced breathing to standardize respHRV measurement. Compared with the preintervention waiting period, improvements were observed during the intervention in most self-reported outcomes. The strongest effects were observed for insomnia (dz = 1.01) and somatic symptoms (dz = 0.84). PTSD improvement did not reach significance (p = 0.08, dz = 0.44). Follow-up data suggested partial persistence of benefits. No significant changes were found in physiologic outcomes. The intervention was well tolerated and positively evaluated, with mostly mild side effects. This study suggests that taVNS combined with slow breathing is feasible and potentially effective, with the most promising effects on insomnia and somatic symptoms. Further investigation in randomized controlled trials is warranted.
Intrahospital transport is often unavoidable in neonatal intensive care, but it may expose critically ill neonates to physiological instability and adverse events. Data from low- and middle-income settings remain limited, and differing hypothermia thresholds across studies may underestimate the true burden of transport-related harm. We conducted a prospective observational pilot study of intrahospital transport episodes from the neonatal intensive care unit (NICU) at a tertiary pediatric center in Ho Chi Minh City, Vietnam, between May and July 2024. Each transport episode was analyzed as a separate event. The primary outcome was unsafe transport, defined as at least one adverse event-including hypothermia <36.5°C, respiratory deterioration, hemodynamic instability, or device-related events-occurring during transport or within 24 h of NICU readmission. The secondary outcome excluded mild hypothermia and included only moderate hypothermia (32°C-35.9°C) and other clinically significant events. Of the 172 screened transport events, 138 involving 96 neonates were included. Under the primary definition, 71 transport events (51.4%) were unsafe, generating 100 adverse events; 89% occurred during the return leg or post-return period. Hypothermia was the most frequent event (74.0%): 40 mild (36.0°C-36.4°C) and 34 moderate (32°C-35.9°C). Under the secondary definition, 44 transport events (31.9%) were unsafe, with 60 adverse events. Transport was significantly associated with increased FiO2 (p = 0.008) and reduced SpO2/FiO2 ratio (p = 0.020). A surgical indication was the strongest independent predictor: moderate Bayesian model averaging evidence for the primary outcome [posterior inclusion probability (PIP) 0.616] and strong evidence for the secondary outcome (PIP 0.880; odds ratio 4.95, 95% credible interval 1.43-17.2). Moderate hypothermia was independently associated with support escalation (41.2% vs. 18.6%, p = 0.018), whereas mild hypothermia was not. The vasoactive-inotropic score showed negligible predictive value, equivalent to vasoactive drug count. Intrahospital transport of critically ill neonates is frequently associated with adverse events, predominantly hypothermia occurring on the return leg. A surgical indication-particularly for esophageal atresia, gastroschisis, or urgent procedures - is the dominant independent risk factor. Improved thermal protection (including routine incubator use for surgical cases), standardized postreturn temperature assessment, and enhanced preparation for surgical transport are the highest-priority evidence-based interventions.
Cystic fibrosis-related diabetes (CFRD) management is evolving as the CF population experiences increasing rates of overweight and obesity, particularly with widespread cystic fibrosis transmembrane conductance regulator (CFTR) modulator use. This article describes practical insights from implementing a pilot program evaluating injectable semaglutide, a GLP-1 receptor agonist (GLP-1 RA), in adults with CFRD. Our program followed 11 participants over 12 months, revealing important considerations for patient selection, monitoring protocols, and managing adverse effects in this unique population. While the majority of participants tolerated semaglutide well with clinically meaningful improvements in glycemic control, careful screening and close follow-up proved essential. These findings offer practical guidance for diabetes educators and clinicians considering GLP-1 RA therapy as an adjunct to insulin in carefully selected patients with CFRD.
The entrance of Generation Z into professional life, including the practice of medicine, marks a transformational shift in priorities and values. This also applies for urology. Consequently, we conducted a pilot survey among European leaders in urology to conduct first insights on generational change and its implications for clinical practice, education and healthcare systems. Between August and October 2025, a survey containing seven open-ended questions was sent out to 11 European leaders in urology. The results are presented in an only descriptive manner. Answers from all experts were received. We summarized the results in four take home messages: 1. Generation Z is capable and expects modern training environments. 2. Structural and legal frameworks drive most observed changes. 3. Reduced clinical presence affects surgical exposure and continuity of care. 4. Traditional apprenticeship models no longer fit current conditions. National and European urological societies, training committees and educational bodies were repeatedly referenced as key platforms for coordinating and implementing such adaptations. We provide first key factors as hypothesis for further discussion and evaluation of educational programs in urology in the future and therefore, improving patient care.
To determine the feasibility of using behavior change techniques in people with acute stroke during hospitalization and to evaluate the preliminary effects of these interventions on the physical activity and mobility of the participants. Nonblinded, parallel-group pilot randomized controlled trial. The trial was conducted in a stroke unit of a university hospital in Germany. A random sample of 24 participants (N=24) was selected. Included were people with acute stroke (<48h after the incident), with National Institutes of Health Stroke Scale score 0-5, who were able to ambulate independently. Participants of the intervention group received 3 behavior change techniques alongside standard physiotherapy during their hospital stay: education, goal setting, and monitoring. In the control group, participants received standard physiotherapy. Feasibility was assessed based on previously established feasibility criteria. Physical activity levels were measured using accelerometry, while mobility was evaluated with the de Morton Mobility Index. Twenty-four participants were recruited in total (participation rate: 77.4%), and 12 of them received the intervention. There were no drop-outs and none lost to follow-up (drop-out rate 0%; retention rate: 100%). The recruitment rate, retention, acceptability, and safety of the intervention were assessed as feasible. The target adherence of 80% potential wear time of an accelerometer could not be confirmed. No adverse events were reported. A trend for higher physical activity of the intervention group was observed; however, the results were not statistically significant. Despite a small number of participants, the feasibility and safety of the use of behavior change techniques in people with acute stroke, as well as indications of a potential effect, were established. Therefore, after implementing adjustments regarding the recruitment and inclusion of participants, the recommendation can be made to conduct a definite trial.
This study aims to estimate the rate of recruitment of participants. This is a pilot, multicentre, double-blind, placebo-controlled, randomised controlled trial of oral oxycodone and sublingual placebo vs sublingual buprenorphine and oral placebo for postoperative pain management for 7 days after pelvic exenteration. Patients will be recruited from three metropolitan quaternary referral centres that offer advanced gastrointestinal surgery in Australia. The inclusion criteria will be patients over the age of 18 years undergoing pelvic exenteration surgery and exclusion criteria are previous adverse events related to the study drugs, currently requiring monoamine oxidase inhibitor medications and if epidural analgesia is planned in the perioperative period. Enrolled patients will undergo pelvic exenteration surgery and be initiated postoperatively on patient-controlled analgesia. In the postoperative period, when clinically appropriate to take oral medications, patients will be commenced on trial analgesia for 7 days. Participants will be randomised to receive either oral active oxycodone 5-10 mg up to 3 hourly as required (with sublingual placebo) or sublingual active buprenorphine 200-400 mcg 3 hourly as required (with oral placebo). The primary outcome measure is the rate of recruitment over a 6-month period. Secondary outcomes include an assessment of missing data, protocol adherence and acceptability of the trial to participants. The trial received ethics approval from Sydney Local Health District, Royal Prince Alfred Hospital Human Research Ethics Committee (No: X25-0128 & 2025/ETH01058). The results of the study will be disseminated by publication and presentation at local annual scientific meetings in Australia. The study protocol is prospectively registered at the Australian New Zealand Clinical Trials Registry (ANZCTR) (www.anzctr.org.au; ACTRN12625000901404).
IC performed by patients themselves is the gold standard for patients suffering from neurogenic lower urinary tract dysfunction. But the process of intermittent self-catheterization (IC) by female patients can be challenging. A usability study for a new assistive device, named and trademarked 2LIP®, for facilitating urethral (IC) use by female patients suffering from a neurogenic disorder of the lower urinary tract (NLUTD) was realized. Leg spreading angles (LSA), forward body push distances (FBPD) and inner labia opening forces were measured in healthy women. A volunteer study group of paraplegic and incomplete tetraplegic female patients was anonymously interviewed and/or tested the new device. LSA was reduced from 50-110° without the device to 20-50° with the device. The range of anteroposterior and mediolateral inner labia opening forces ranged between 2 and 18N in 4 healthy subjects. FBPD was reduced modestly. 20 paraplegic and incomplete tetraplegic female patients were interviewed. In 20 tests, the first generation 2LIP opened the labia in 3 out of 9 women because the device was mechanically too short, whereas the optimized second generation opened the inner labia in 9 of 11 subjects successfully. 2LIP® enabled a reduction of the required LSA and a slightly reduced FBPD, which may lead to a more ergonomic, safer and facilitated self-catheterization. Labia opening forces can be used to quantify the mechanical device requirements. Women seek improvements in the self-catheterization procedure and see potential benefits from 2LIP®. Greater independence in continence is of individual and societal interest. Nursing efforts may be reduced. Easier self-catheterization may help raise the individual frequency of IC.
To determine the time spent by technical staff in the anatomical pathology department on each of the processes in which they were involved, and to define a workload unit. The time required for technical procedures was measured over 5 days in 10 hospitals. The median time for each process was calculated. The time required for registration was 3.92min/specimen; for embedding of small specimens, 1.96min/specimen; for embedding of large specimens 10.91min/specimen; for microtomy, 1.01min/specimen; for immunohistochemistry, 2.13min/specimen; for liquid-based cytology, 4.02min/specimen; and for archiving, 0.49min/specimen. The technical workload unit (TWU) is set at 11min, corresponding to the rounding of 10.91min/specimen for large-specimen embedding, as this is the most time-consuming task. Thus, TWU values range from 0.09TWU/specimen for block preparation and sectioning to 1TWU/specimen for large-specimen embedding.
Bone metabolism is typically impaired in patients with acromegaly due to increased bone turnover, increased bone resorption, and impaired bone neoformation. The pathogenetic mechanisms underlying skeletal fragility in patients with acromegaly remain not fully clarified. We aim to compare the bone proteome of patients with acromegaly to that of a control group of patients with non-secreting pituitary tumors (NSPTs). A Liquid Chromatography-Mass Spectrometry was conducted on ethmoid samples (after processing and digestion of the sample) of five patients with acromegaly and five patients with NSPTs, to identify and assay the proteome. Biological functions were investigated for proteins that were found quantitatively up- and down-regulated in the bone of acromegalic patients, with a ratio of variation based on Fold-Change (FC) >|1.50| and statistical significance (p-value < 0.05). 312 proteins belonging to each group were identified. Six proteins with positive FC (up-regulated) and 12 proteins with negative FC (down-regulated) significantly differ in patients with acromegaly than in patients with NSPTs. Among up- and down-regulated proteins, profilin-1, isoform 5 of the periostin, apolipoprotein E, and caveolin-1 were known to be involved in bone metabolism. In our cohort, a positive correlation was detected between the profilin-1, the isoform 5 of the periostin, GH, and IGF-I levels; and a negative correlation was detected between caveolin-1 and serum GH and IGF-I levels, and with apolipoprotein E and serum IGF-I levels. Our results proved that the bone of patients with acromegaly is characterized by a specific proteomic profile, which is closely correlated to GH and IGF-I hypersecretion.
This study aimed to evaluate the effects of dietary composition, physical activity, and body mass index on gallbladder recovery time following food consumption and to identify alternative scan preparation strategies for patients unable to fast before abdominal ultrasound. A quasi-experimental study involving 26 participants was conducted using four ultrasound sessions under different conditions: consumption of each dietary item with and without moderate physical activity. Gallbladder wall thickness and volume were measured hourly following standardised ultrasound protocols. Measurement reliability was assessed using the intraclass correlation coefficient on 30 randomly selected scans reviewed by two independent observers. Recovery time significantly varied among meal types (χ²(2) = 18.42, p < .001), with wholemeal bread yielding the fastest and yogurt the slowest recovery. Physical activity significantly enhanced wall recovery (p = 0.002) but did not affect volume (p = 0.317). Body mass index showed no significant effect. Moderate and excellent intraclass correlation coefficients were achieved for gallbladder wall thickness (0.52) and volume (0.88), respectively. Wholemeal bread and postprandial physical activity serve as effective alternatives for ultrasound preparation when assessing gallbladder wall recovery. These findings promote patient-specific ultrasound protocols to improve diagnostic efficiency and comfort.