In medicine and public health, the randomised controlled trial (RCT) is generally considered the key generator of 'gold standard' evidence. However, basic and clinical research and trials are often unrepresentative of real-world populations. Recruiting insufficiently diverse cohorts of participants in trials (e.g. in terms of socioeconomic status, racial and ethnic background, or sex and gender) may not only overstate the general effectiveness of a technology; it may also actively increase health inequalities. We highlight some general issues in this domain, before discussing several specific illustrative examples in the context of medical devices. High quality evidence on factors that would improve trial recruitment is extremely limited. There is a clear need for research on candidate strategies for improving recruitment of under-represented groups in RCTs. These could include, for example, offering various forms of financial incentives; non-monetary incentives, such as preferential access to the technologies that are being tested if they are found to be effective; and various types of informational messages and nudges; as well as involvement of community partners and champions in the recruitment process. Ideally, recruitment practices should ultimately be based on evidence generated from RCTs. Studies Within a Trial (SWAT), where randomised experiments are built into the actual recruitment processes in RCTs, are an ideal way to gain this evidence. SWAT studies are seeing an increase in traction, as indicated by funding streams in bodies such as the UK-based NIHR. Making greater funding available for studies of this kind is needed to improve the evidence base on how best to improve diversity in trial recruitment.

Lower limb amputation has been well characterized in the literature to cause resultant osteoarthritis in the hip of the contralateral limb. This further amplifies the already significant physical disability and morbidity that come with lower limb amputation. The use of total hip arthroplasty (THA) in patients with lower limb amputations is rare, with available literature subsequently also limited. In this case report, we describe a 52-year-old female with a right proximal femur (subtrochanteric) amputation who underwent left THA due to osteoarthritis. To our knowledge, this is the first published report describing THA, via direct anterior approach, in a patient with contralateral proximal femur (subtrochanteric) amputation. We discuss the complex surgical considerations for this patient population, selection of approach, prosthesis, and postoperative outcomes.

Patients With Stroke (PWS), like patients with other chronic health conditions, need long-term care in home settings. Patient transfer from hospital to home is associated with challenges such as care quality impairment and ineffective patient need fulfillment. The aim of this study was to assess the principles of Home Care (HC) for PWS.

This integrative review was conducted in 2023 using the method recommended by Whittemore and Knafl. The Web of Science, Google Scholar, ScienceDirect, ProQuest, Scopus, Cumulative Index to Nursing and Allied Health Literature, PubMed, and specific databases for stroke care guidelines were searched to find relevant articles published between 2010 and 2023. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was used for document screening and selection. The data were analyzed using the constant comparison method.

Primarily, 2608 documents were retrieved, and 22 of them were included in data analysis. The principles of HC for PWS were categorized into six main categories: principles of transition from hospital care to HC, principles of assessment for HC, principles of education for HC, principles of designing an HC plan, principles of HC measures, and principles of discharge from HC centers.

The present study provides a detailed overview of the principles of HC for PWS, which can be used to develop standard guidelines and improve the quality of HC for PWS.

We conducted the first non-inferiority, randomised controlled trial to determine whether lifestyle therapy is non-inferior to psychotherapy with respect to mental health outcomes and costs when delivered via online videoconferencing.

An individually randomised, group treatment design with computer-generated block randomisation was used. Between May 2021-April 2022, 182 adults with a Distress Questionnaire-5 score = ≥8 (indicative depression) were recruited from a tertiary mental health service in regional Victoria, Australia and surrounds. Participants were assigned to six 90-min sessions over 8-weeks using group-based, online videoconferencing comprising: (1) lifestyle therapy (targeting nutrition, physical activity) with a dietitian and exercise physiologist (n = 91) or (2) psychotherapy (Cognitive Behavioural Therapy) with psychologists (n = 91). The primary outcome was Patient Health Questionnaire-9 (PHQ-9) depression at 8-weeks (non-inferiority margin ≤2) using Generalised Estimating Equations (GEE). Cost-minimisation analysis estimated the mean difference in total costs from health sector and societal perspectives. Outcomes were assessed by blinded research assistants using Computer Assisted Telephone Interviews. Results are presented per-protocol (PP) and Intention to Treat (ITT) using beta coefficients with 95% Confidence Intervals (CIs).

The sample was 80% women (mean: 45-years [SD:13.4], mean PHQ-9:10.5 [SD:5.7]. An average 4.2 of 6 sessions were completed, with complete data for n = 132. Over 8-weeks, depression reduced in both arms (PP: Lifestyle (n = 70) mean difference:-3.97, 95% CIs:-5.10, -2.84; and Psychotherapy (n = 62): mean difference:-3.74, 95% CIs:-5.12, -2.37; ITT: Lifestyle (n = 91) mean difference:-4.42, 95% CIs: -4.59, -4.25; Psychotherapy (n = 91) mean difference:-3.82, 95% CIs:-4.05, -3.69) with evidence of non-inferiority (PP GEE β:-0.59; 95% CIs:-1.87, 0.70, n = 132; ITT GEE β:-0.49, 95% CIs:-1.73, 0.75, n = 182). Three serious adverse events were recorded. While lifestyle therapy was delivered at lower cost, there were no differences in total costs (health sector adjusted mean difference: PP AUD$156 [95% CIs -$182, $611, ITT AUD$190 [95% CIs -$155, $651] ]; societal adjusted mean difference: PP AUD$350 [95% CIs:-$222, $1152] ITT AUD$ 408 [95% CIs -$139, $1157].

Remote-delivered lifestyle therapy was non-inferior to psychotherapy with respect to clinical and cost outcomes. If replicated in a fully powered RCT, this approach could increase access to allied health professionals who, with adequate training and guidelines, can deliver mental healthcare at comparable cost to psychologists.

This trial was funded by the Australian Medical Research Future Fund (GA133346) under its Covid-19 Mental Health Research Grant Scheme.

We examined the inter-correlation between diet quality, objectively measured sleep duration, and subjectively measured sleep quality with flash glucose monitoring (FGM)-measured glycemia among young patients with type 1 diabetes (T1D).

Following cross-sectional design, Fitbit® accelerometers were used to objectively assess sleep duration, while the validated questionnaires Pittsburgh sleep quality index and Mediterranean diet (MD) adherence were used to subjectively assess sleep quality and diet quality, respectively. Glycated hemoglobin (HbA1c) and FGM-reported glycemia components among children with T1D were assessed as well.

Of the 47 participants surveyed (25 boys, 22 girls, 9.31 ± 2.88 years), the majority reported high HbA1c, good sleep quality, and high adherence to the MD. However, only one-third of the participants reported a healthy sleep duration. Only the sleep latency was significantly (P < 0.05) associated with the time above range level 2 and time below range level 2 (P = 0.048) components of the FGM. A positive correlation (r = 0.309, P = 0.035) was reported between adherence to MD and time in range of the FGM.

Diet quality and sleep quality are variably inter-correlated with FGM-measured glycemia among young patients with T1D and are suggested to be considered influential factors in FGM-monitored diabetes research on this age group.

Engaging in empowering exercise develops movement competency (MC) and strength and supports physical health, mental well-being, and quality of life. Powerbuilding combines powerlifting and bodybuilding to increase physical activity (PA), MC, and strength. To our knowledge, powerbuilding has not been explored as an exercise intervention. This pilot study investigated the impact of an eight-week powerbuilding intervention on women's PA, MC, strength, and empowerment. Eighteen women aged 25.1±9.8 with no powerbuilding experience participated in the intervention, meeting three times weekly for one hour. PA and MC were assessed pre- and post-intervention. Three-repetition maximum (3-RM) tests in the squat, bench press, and deadlift were completed in weeks one and eight of the intervention. Data were checked for normality; the Wilcoxon signed-rank test was used for non-normally distributed data. The McNemar test was used to analyze differences in dichotomous variables. Effect size was calculated and interpreted as follows small (r=0.1, d=0.2, ω=0.1), medium (r=0.3, d=0.5, ω=0.3), and large (r=0.5, d=0.8, ω=0.5) Total PA ([t(17)=3.52, p=0.003, d=0.83]) and participants who met the PA guidelines (Z=6.13, p=0.008, ω=0.82) increased significantly from pre- to post-intervention. Participants' MC scores improved significantly from pre- (24.3±3.5) to post-intervention (29.5±2.5; [t(17)=10.04, p<0.001; d=2.37]). Significant increases in strength were observed (squat [Z=-3.73, p<0.001, r=0.88], bench press [Z=-3.73, p<0.001, r=0.88], and deadlift [t(17)=16.41, p<0.001; d=3.87]). Empowerment in exercise scores averaged 56.3±6.6 (on a scale of 5-65). The intervention significantly increased total PA, improved MC, increased strength, and facilitated empowerment. Women's participation in powerbuilding may enhance their quality of life.

Engaging diverse populations in clinical trials is vital to research. This study evaluated the effects of varying recruitment messages for a clinical trial.

The messages were evaluated in a randomly assigned, factorial design that tested enhanced trust (vs. standard) and participant endorsement (vs. standard) messaging.Four postcards were developed and randomly assigned to 4000 potential participants' addresses. Except for the messages of interest, the cards were identical, and participants were directed to four identical study websites and screening forms. Outcomes include unique website visits, visit conversion rate, screening forms completed, and participants randomized into the parent study.

Study websites received 74 visits (range by message type 9 to 34). There was no significant difference by message type (p = 0.79). Online screening forms were completed by 15 participants (range by message type 0-6), representing a conversion rate of 20.3% of website visits. Seven participants were randomized into the study in response to the postcards (range by message type 0 to 3; 46.7% of screenings). Overall, 0.2% of individuals who received a postcard were randomized into the study.

Despite developing recruitment messages with participant input, the enhanced messages did not yield a greater response than standard messages. However, this method of evaluating recruitment messages shows promise.

Hepatic arterial infusion pump (HAIP) chemotherapy is an effective treatment for patients with unresectable intrahepatic cholangiocarcinoma (iCCA). HAIP chemotherapy requires a catheter inserted in the gastroduodenal artery and a subcutaneous pump. The catheter can be placed using an open or robotic approach.

This study aimed to compare perioperative outcomes of robotic versus open HAIP placement in patients with unresectable iCCA.

We analyzed patients with unresectable iCCA included in the PUMP-II trial from January 2020 to September 2022 undergoing robotic or open HAIP placement at Amsterdam UMC, Erasmus MC, and UMC Utrecht. The primary outcome was time to functional recovery (TTFR).

In total, 22 robotic and 28 open HAIP placements were performed. The median TTFR was 2 days after robotic placement versus 5 days after open HAIP placement (p < 0.001). One patient (4.5%) in the robotic group underwent a conversion to open because of a large bulky tumor leaning on the hilum immobilizing the liver. Postoperative complications were similar-36% (8/22) after robotic placement versus 39% (11/28) after open placement (p = 1.000). The median length of hospital stay was shorter in the robotic group-3 versus 5 days (p < 0.001). All 22 robotic patients initiated HAIP chemotherapy post-surgery, i.e. 93% (26/28) in the open group (p = 0.497). The median time to start HAIP chemotherapy was 14 versus 18 days (p = 0.153).

Robotic HAIP placement in patients with unresectable iCCA is a safe and effective procedure and is associated with a significantly shorter TTFR and hospital stay than open HAIP placement.

Background: Trauma exposure prevalence and consequent post-traumatic stress disorder among South African adolescents are significant. Sleep disturbances are among the most frequently reported difficulties faced by those dealing with PTSD. The current study examined the feasibility and preliminary efficacy of the South African Adolescence Group Sleep Intervention on PTSD symptom severity and sleep disturbance.Method: Sixty-one adolescents with PTSD diagnoses and sleep disturbance were randomly assigned (1:1) to one individual and four group sessions of a sleep intervention (SAASI) or a control group. Participants completed the Child PTSD symptom scale for DSM5 (CPSS-5) and the Pittsburgh Sleep Quality Index (PSQI) among other sleep and psychiatric measures. The trial was registered on the Pan African Trial Registry (PACTR202208559723690).Results: There was a significant but similar decrease in PSQI scores in both groups over time indicating no overall intervention effect (Wald test = -2.18, p = .029), mean slope = -0.2 (95% CI: -0.37 to -0.02) (p = .583). On the CPSS-5, interaction between groups was also not significant (p = .291). Despite this overall finding, the mean difference in CPSS-SR-5 scores increased over time, with the difference between groups post-treatment -9.10 (95%CI: -18.00 to -0.21), p = .045 and the 1-month follow-up contrast - 11.22 (95%CI: -22.43 to -0.03), p = .049 suggesting that PTSD symptom severity decreased more in the intervention group than the control group. The dropout rate was higher than expected for both the intervention (n = 10; 32%) and control (n = 8; 26.7%) groups. Dropout were mostly school commitments or travel related.Conclusions: Early findings suggest a trend towards dual improvement in sleep quality and PTSD symptom severity in adolescents with a sleep disturbance and PTSD receiving a group sleep intervention (SAASI). Further investigation in a properly powered RCT with detailed retention planning is indicated.

Generally, the health condition of those with higher socioeconomic status (SES) is better compared to those with lower SES. The application of appropriate strategies to reach low SES populations with electronic health (eHealth) interventions is thus of major importance to reduce health inequalities. eHealth-studies providing detailed information on recruitment strategies are scarce, despite the fact that this information is crucial for comparable research and implementation.

To provide insight into the reach, sample characteristics and costs of three pre-planned strategies for recruiting adults aged 50 years and older with low SES for participation in an online physical activity intervention, as part of a field study.

Recruitment took place via (1) invitation letters via a municipality, (2) gyms and (3) social media advertisements, aiming to include 400 participants. Additional procedures were followed to reach specifically the low SES group. Response rates, sociodemographic characteristics and costs per strategy were assessed.

The highest response was shown for the municipality approach (N = 281), followed by social media (N = 71) and gyms (N = 45). Ten participants were recruited via family/friends. The most low-educated participants were reached via the municipality (N = 128) followed by social media (N = 9), gyms (N = 8) and family/friends (N = 5). Recruitment costs were with €2,142.37 the highest for the municipality compared to €96.81 for social media and no costs for gyms.

Recruitment via invitation letters through a municipality has the highest potential for reaching low SES participants of the three applied strategies, although the higher recruitment costs need to be taken into account.

Physical activity and exercise are important aspects of maintaining health. People with mobility impairments, including survivors of stroke, are less likely to exercise and at greater risk of developing or worsening chronic health conditions. Increasing accessible, desired options for exercise may address the gap in available physical activity programs, provide an opportunity for continued services after rehabilitation, and cultivate social connections for people after stroke and others with mobility impairments. Existing evidence-based community programs for people after stroke target cardiovascular endurance, mobility, walking ability, balance, and education. While much is known about the effectiveness of these programs, it is important to understand the local environment as implementation and sustainment strategies are context-specific.

This study protocol aims to evaluate community needs and resources for exercise for adults living with mobility impairments with initial emphasis on survivors of stroke in Richland County, South Carolina. Results will inform a hybrid type I effectiveness and implementation pilot of an evidence-based group exercise program for survivors of stroke.

The exploration and preparation phases of the EPIS (Exploration, Preparation, Implementation, and Sustainment) implementation model guide the study. A community needs assessment will evaluate the needs and desires of survivors of stroke through qualitative semistructured interviews with survivors of stroke, rehabilitation professionals, and fitness trainers serving people with mobility impairments. Additional data will be collected from survivors of stroke through a survey. Fitness center sites will be assessed through interviews and the Accessibility Instrument Measuring Fitness and Recreation Environments inventory. Qualitative data will be evaluated using content analysis and supported by mean survey results. Data will be categorized by the community (outer context), potential participants (outer context), and fitness center (inner context) and evaluate needs, resources, barriers, and facilitators. Results will inform evidence-based exercise program selection, adaptations, and specific local implementation strategies to influence success. Pilot outcome measures for participants (clinical effectiveness), process, and program delivery levels will be identified. An implementation logic model for interventions will be created to reflect the design elements for the pilot and their complex interactions.

The study was reviewed by the institutional review board and exempt approved on December 19, 2023. The study data collection began in January 2024 and is projected to be completed in June 2024. A total of 17 participants have been interviewed as of manuscript submission. Results are expected to be published in early 2025.

Performing a needs assessment before implementing it in the community allows for early identification of complex relationships and preplanning to address problems that cannot be anticipated in controlled effectiveness research. Evaluation and preparation prior to implementation of a community exercise program enhance the potential to be successful, valued, and sustained in the community.

DERR1-10.2196/55432.

Informed consent as stipulated in regulatory human research guidelines requires volunteers to be well-informed about what will happen to them in a trial. However, researchers may be faced with the challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. This study aimed to find out volunteers' comprehension of informed consent and voluntary participation in Human Immunodeficiency Virus (HIV) clinical trials during the registration cohort.

We conducted a qualitative study among volunteers who were enrolled in the registration cohort of HIV clinical trials in Dar es Salaam, Tanzania. A purposive sampling strategy was used to obtain twenty study participants. The data were collected between June and September 2020 using a semi-structured interview guide. In-depth interviews were used to collect the data to obtain deep insights of the individual study participants on the comprehension of informed consent and participation in the clinical trial. A thematic analysis approach was used to analyze the data. Themes and subthemes were supported by the quotes from the participants.

Volunteers described comprehension of informed consent from different perspectives. They reported that various components of the informed consent such as study procedure, confidentiality, risk and benefits were grasped during engagement meetings. Furthermore, the volunteers' decision to participate in the registration cohort was voluntary. However, trial aspects such as health insurance, free condoms, and medical checkups could have indirectly influenced their reluctance to withdraw from the study.

Engagement meetings may increase the comprehension of informed consent among potential participants for HIV clinical trials. However, trial incentives may influence participation, and thus future research should focus on the challenges of giving incentives in the study. This will ensure comprehension and voluntary participation in the context of HIV clinical trials.

Despite the widespread use of the Bacillus Calmette-Guérin (BCG) vaccine, Mycobacterium tuberculosis (MTB) continues to be a global burden. Vaccination has been proposed to prevent and treat tuberculosis (TB) infection, and several of them are in different phases of clinical trials. Though vaccine production is in progress but requires more attention. There are several TB vaccines in the trial phase, most of which are based on a combination of proteins/adjuvants or recombinant viral vectors used for selected MTB antigens. In this review, we attempted to discuss different types of TB vaccines based on the vaccine composition, the immune responses generated, and their clinical trial phases. Furthermore, we have briefly overviewed the effective delivery systems used for the TB vaccine and their effectiveness in different vaccines.

Pancreatic ductal adenocarcinoma (PDAC) remains a highly lethal malignancy with a minority of patients eligible for curative-intent surgical intervention. Pancreatic resections are technically demanding operations associated with considerable morbidity and mortality. Minimally invasive pancreatic resections (MIPRs), which include laparoscopic and robotic approaches, may enhance postoperative outcomes by lessening physiological impact of open surgery. A limited number of randomized-controlled trials as well as numerous retrospective reports have focused on MIPR outcomes and role in management of a variety of tumors, including PDAC. Today, MIPRs are generally considered acceptable alternatives to open surgery as a trend towards improved short-term metrics is observed. However, several questions remain regarding the oncological adequacy of MIPR's as long-term experience is less extensive compared to open techniques. This review aims to summarize existing evidence on MIPRs with a focus on PDAC.

Given the dire need for health and rehabilitation services internationally, exacerbated during the COVID-19 pandemic, there is a critical need to develop tools to support service delivery. This need is palpable in the Global South where tools developed in Eurocentric contexts are not always adaptable, applicable, or relevant. It is for this reason that the researchers present three case studies of tool development using pilot and feasibility studies in South Africa and share the lessons learned from these studies.

To describe three case studies that developed new tools for health and rehabilitation services using pilot and feasibility studies. To synthesize lessons learned from these case studies on the development of tools.

The researchers describe three case studies that were developed. The case studies are summarized as follows: aims and objectives, context, problem, study design, findings, and what happened after the study. Thereafter, a qualitative cross-case analysis was conducted by the researchers to generate themes.

The case studies are described individually and followed by themes identified through cross-case analysis.

The lessons learned are discussed. It is essential to develop new tools and protocols, motivated by the need for equitable and contextually relevant practices. Partnerships and collaboration with end-users are critical for success. A critical, scientific process is essential in developing new tools. Pilot and feasibility studies are invaluable in developing tools and assessing the feasibility of tools and implementation. The goal is to develop practical, usable tools and protocols.

Through the lessons learned, the researchers are hopeful that the international health and rehabilitation professions will continue to strengthen the scientific development of contextually relevant tools and resources.

Background: Distal pancreatectomy (DP) represents the best therapeutic option for patients with body-tail pancreatic neoplasms (PNs). The enhanced recovery after surgery protocol is widely used for treating patients with PN to speed up postoperative recovery. This study aims to describe our institute's experience in the application of fast recovery protocol in a cohort of patients treated with DP, identifying predictors facilitating a decrease in the length of hospital stay. Patient and Methods: Were retrospectively enrolled 60 consecutive cases of DP performed from January 2016 to June 2022 in patients treated with enhanced recovery protocol, 25% of them were treated with spleen preserving procedure. Single-variable logistic regression models were used to evaluate the potential association between patient characteristics and the probability of postoperative complications. Standard linear regression models were used for length of stay, number of postoperative days (PODs) from surgery to full bowel function recovery, and PODs to the interruption of intravenous analgesia administration. Results: Thirty-four (57%) patients underwent open surgery and 26 (43%) laparoscopic surgery. Patients who underwent laparoscopic surgery and spleen-preserving procedures experienced a lower complication rate (P = .037), shorter length of stay, and time of analgesic requirements. With single-variable logistic regression models patients treated with laparoscopic surgery had statistically significant higher recovery times in terms of nasogastric tube removal (P = .004) and early enteral nutrition (P = .001). Conclusion: Continual refinement with enhanced recovery protocol for treating PN patients based on perioperative counseling and surgical decision-making is crucial to reduce patient morbidity and time for recovery.

Robotic pancreaticoduodenectomy (RPD) is technically demanding, and 20-50 cases are required to surpass the learning curve. This study aimed to show our experience of 76 cases from the introduction of RPD and report the changes in surgical results owing to the accumulation of cases and optimization of surgical techniques.

A total of 76 patients who underwent RPD between November 2009 and May 2023 at the Fujita Health University Hospital were divided into three groups: competency (n = 23, Nov 2009-Mar 2020), proficiency (n = 31, Apr 2020-Jun 2022), and mastery (n = 22, Jul 2022-May 2023) phases. In the mastery phase, for the education of new surgeons and maintenance of surgical quality, optimization of the procedure, including hanging maneuver with or without stapling transection of the retropancreatic tissue was implemented. The surgical outcomes were compared between the groups.

The mean operation time decreased over time despite of the participation of newly started operators in mastery phase [competency: 921.5 min (IQR 775-996 min) vs. proficiency: 802.8 min (IQR 715-887 min) vs. mastery: 609.2 min (IQR 514-699 min), p < 0.001]. Additionally, Clavien-Dindo ≥ grade IIIa complications decreased from 52.2% in competency phase to 35.5% and 9.1% in proficiency and mastery phases, respectively (p = 0.005).

Operation time and major complications decreased along the learning curve from the introduction of RPD. In addition, optimization of the procedure, including hanging maneuver of the retropancreatic tissue seemed to be effective in reducing operation time and educating new RPD surgeons.

Regular physical activity may promote beneficial neuroplasticity, e.g., increased hippocampus volume. However, it is unclear whether self-reported physical exercise in leisure (PEL) levels are associated with the brain structure features demonstrated by exercise interventions. This pilot study investigated the relationship between PEL, mood, cognition, and neuromorphometry in patients with idiopathic generalized epilepsy (IGEs) compared to healthy controls (HCs). Seventeen IGEs and 19 age- and sex-matched HCs underwent magnetic resonance imaging (MRI) at 3T. The Baecke Questionnaire of Habitual Physical Activity, Profile of Mood States, and Montreal Cognitive Assessment (MoCA) assessed PEL, mood, and cognition, respectively. Structural MRI data were analyzed by voxel- and surface-based morphometry. IGEs had significantly lower PEL (p < 0.001), poorer mood (p = 0.029), and lower MoCA scores (p = 0.027) than HCs. These group differences were associated with reduced volume, decreased gyrification, and altered surface topology (IGEs < HCs) in frontal, temporal and cerebellar regions involved in executive function, memory retrieval, and emotional regulation, respectively. These preliminary results support the notion that increased PEL may promote neuroplasticity in IGEs, thus emphasizing the role of physical activity in promoting brain health in people with epilepsy.

Malignant tumours within the proximal pancreas traditionally require pancreaticoduodenectomy (PD) for cure. For smaller lesions with borderline malignant potential the risk/benefit of PD becomes difficult to justify. Robotic approaches to these lesions allow for parenchymal preserving resection with reduced complication profile without oncological compromise.

A review of a single surgeons prospectively collated database across two institutions of consecutive robotic enucleations or parenchyma preserving resections of the proximal pancreas was performed between July 2018 and October 2021. Standard demographic data, preoperative variables, intraoperative parameters, post-operative outcomes, morbidity and mortality were recorded.

Thirteen patients (8 female and 5 male) underwent robotic enucleation (EN) (8) and/or uncinectomy (UN) (5) in the proximal pancreas. Mean BMI was 32(kg/m2 ). Three patients (21%) underwent preoperative prophylactic pancreatic duct stenting. One patient required conversion to open. The median operative time in the EN group was 170 min (108-224 min) and the UN group was 160 min (110-204 min). The majority (8) of lesions were pNETs. Three lesions were IPMNs, with 1 solitary fibrous tumour and a serous cystic neoplasm (SCN) respectively. Median tumour size was 23 mm (11-58 mm) in the EN group, and 27 mm (17-38 mm) in the UN group. Ten of 13 patients had an R0 resection. There was no mortality in our series. Four (31%) patients across both groups developed clinically relevant POPF while none developed new endocrine or exocrine insufficiency. Average outpatient follow-up has been 6 months (1-18 months).

A robotic approach in proximal parenchymal preserving pancreatectomy is expanding, safe and feasible.

Creating a tunnel between the pancreas and splenic vessels followed by pancreatic parenchyma transection ("tunnel-first" strategy) has long been used in spleen-preserving distal pancreatectomy (SPDP) with splenic vessel preservation (Kimura's procedure). However, the operation space is limited in the tunnel, leading to the risks of bleeding and difficulties in suturing. We adopted the pancreatic "parenchyma transection-first" strategy to optimize Kimura's procedure.

The clinical data of consecutive patients who underwent robotic SPDP with Kimura's procedure between January 2017 and September 2022 at our center were retrieved. The cohort was classified into a "parenchyma transection-first" strategy (P-F) group and a "tunnel-first" strategy (T-F) group and analyzed.

A total of 91 patients were enrolled in this cohort, with 49 in the T-F group and 42 in the P-F group. Compared with the T-F group, the P-F group had significantly shorter operative time (146.1 ± 39.2 min vs. 174.9 ± 46.6 min, P < 0.01) and lower estimated blood loss [40.0 (20.0-55.0) mL vs. 50.0 (20.0-100.0) mL, P = 0.03]. Failure of splenic vessel preservation occurred in 10.2% patients in the T-F group and 2.4% in the P-F group (P = 0.14). The grade 3/4 complications were similar between the two groups (P = 0.57). No differences in postoperative pancreatic fistula, abdominal infection or hemorrhage were observed between the two groups.

The pancreatic "parenchyma transection-first" strategy is safe and feasible compared with traditional "tunnel-first strategy" in SPDP with Kimura's procedure.

In this systematic review and meta-analysis, we sought to identify whether extracorporeal shockwave lithotripsy (ESWL) or ureteroscopic lithotripsy (URSL) is the most appropriate method for treating ureteral stones.

We identified relevant literature by searching the Google Scholar and PubMed databases in accordance with PRISMA guidelines. We focused on the outcomes of extracorporeal shockwave lithotripsy and ureteroscopic lithotripsy. For each method, we compared complications, hematuria, perforation, failure, stone clearance, initial stone-free, operating time, stone size, auxiliary procedures, and overall stone-free outcomes. Our analysis involved meta-analysis, heterogeneity testing, subgroup analysis, meta-regression sensitivity analyses, Egger's tests, Smoothed Variance Egger's (SVE) testing, and Smoothed Variance Thomson (SVT) testing. In addition, we detected publication bias for all outcomes related to the two procedures.

Based on ten eligible studies, we conducted a meta-analysis on a total of 1509 patients. Extracorporeal shockwave lithotripsy was used to treat 677 patients; the remaining 832 patients were treated by the ureteroscopic lithotripsy procedure. Considering the meta-analysis statistical parameters including odds ratio (OR), standardized mean difference (SMD), Q, I² and their p-values, the overall stone-free, operating time, stone size outcomes were identified with significant OR, SMD, and Q values. The hematuria, failure, and stone clearance outcomes were determined to have significant Q values. The perforation and initial stone free outcomes had significant OR values. And, complications and auxiliary urinary procedures were not significant in terms of OR and Q values.

Analysis indicated that ESWL and URSL procedures are essential for the treatment of ureteral stones, even though the perforation rate is higher for URSL than for ESWL. Overall stone-free rates were better for the URSL procedure.

Injuries during adolescence cause lifelong harm and death. Our study used a nationally representative sample to examine the prevalence and risk factors associated with serious injuries among in-school adolescents in Panama.

We analysed Panama's 2018 Global School-Based Student Health Survey data using SPSS. Percentages were used to summarise the results of the prevalence of serious injuries. Binomial logistic regression analysis was performed to examine the risk factors of serious injuries. The results were presented as an adjusted odds ratio (AOR) at a 95% confidence interval (CI).

The prevalence of serious injury among in-school adolescents in Panama is 45%. Furthermore, the study found that males (AOR= 1.495, CI=1.272--1.756), truancy (AOR=1.493, CI=1.249--1.785), overweight (AOR= 1.246, 95% CI=11.057--1.469), drinking alcohol (AOR= 1.397, CI=1.151--1.695), experiencing physical attack (AOR= 2.100, CI=11.646--2.681), engaging in a physical fight (AOR=1.586, CI=1.289--1.952) and bullied outside school (AOR=1.276, CI=1.005--1.621) significantly predict serious injuries among adolescents in Panama.

Multidisciplinary approaches targeting the correlates observed will help reduce the high prevalence of serious injuries among in-school adolescents in Panama.

Older adults living with the complexity of multiple long-term conditions (MLTC), frailty and a recent deterioration in health are under-served by research. As a result, current treatment guidelines are often based on data from studies of younger and less frail participants, and often single disease focused. The aims of this review were (i) to identify why older adults living with the complexity of MLTC, frailty and a recent deterioration in health are under-served by research and (ii) to identify strategies for increasing their recruitment and retention. Although a range of factors have been suggested to affect the participation of older adults with MLTC and frailty in research, this review shows that much less is known about the inclusion of older adults living with the complexity of MLTC, frailty and a recent deterioration in health. Researchers should focus on strategies that minimise participation burden for these patients, maintaining an adaptive and flexible approach, to increase their recruitment and retention. Future research should include qualitative interviews to provide further insights into how best to design and conduct research to suit the needs of this population group.

The preoperative total bilirubin-albumin ratio (TBAR) and fibrinogen-albumin ratio (FAR) have been proven to be valuable prognostic factors in various cancers.

To detect the prognostic value of TBAR and FAR in ampullary adenocarcinoma (AC) patients who underwent curative pancreaticoduodenectomy.

AC patients who underwent curative pancreaticoduodenectomy in the National Cancer Center of China between 1998 and 2020 were retrospectively reviewed. The prognostic cutoff values of TBAR and FAR were determined through the best survival separation model. Then, a novel prognostic score combining TBAR and FAR was calculated and validated through the logistic regression analysis and Cox regression analysis.

A total of 188 AC patients were enrolled in the current study. The best cutoff values of TBAR and FAR for predicting overall survival were 1.7943 and 0.1329, respectively. AC patients were divided into a TBAR-low group (score = 0) vs a TBAR-high group (score = 1) and a FAR-low group (score = 0) vs a FAR-high group (score = 1). The total score was calculated as a novel prognostic factor. Multivariable logistic regression analysis revealed that a high score was an independent protective factor for recurrence [score = 1 vs score = 0: Odds ratio (OR) = 0.517, P = 0.046; score = 2 vs score = 0 OR = 0.236, P = 0.038]. In addition, multivariable survival analysis also demonstrated that a high score was an independent protective factor in AC patients (score = 2 vs score = 0: Hazard ratio = 0.230, P = 0.046).

A novel prognostic score based on preoperative TBAR and FAR has been demonstrated to have good predictive power in AC patients who underwent curative pancreaticoduodenectomy. However, more studies with larger samples are needed to validate this conclusion.

Minimally invasive pancreatoduodenectomy (MIPD) aims to reduce the negative impact of surgery as compared to open pancreatoduodenectomy (OPD) and is increasingly becoming part of clinical practice for selected patients worldwide. However, the safety of MIPD remains a topic of debate and the potential shorter time to functional recovery needs to be confirmed. To guide safe implementation of MIPD, large-scale international randomized trials comparing MIPD and OPD in experienced high-volume centers are needed. We hypothesize that MIPD is non-inferior in terms of overall complications, but superior regarding time to functional recovery, as compared to OPD.

The DIPLOMA-2 trial is an international randomized controlled, patient-blinded, non-inferiority trial performed in 14 high-volume pancreatic centers in Europe with a minimum annual volume of 30 MIPD and 30 OPD. A total of 288 patients with an indication for elective pancreatoduodenectomy for pre-malignant and malignant disease, eligible for both open and minimally invasive approach, are randomly allocated for MIPD or OPD in a 2:1 ratio. Centers perform either laparoscopic or robot-assisted MIPD based on their surgical expertise. The primary outcome is the Comprehensive Complication Index (CCI®), measuring all complications graded according to the Clavien-Dindo classification up to 90 days after surgery. The sample size is calculated with the following assumptions: 2.5% one-sided significance level (α), 80% power (1-β), expected difference of the mean CCI® score of 0 points between MIPD and OPD, and a non-inferiority margin of 7.5 points. The main secondary outcome is time to functional recovery, which will be analyzed for superiority. Other secondary outcomes include post-operative 90-day Fitbit™ measured activity, operative outcomes (e.g., blood loss, operative time, conversion to open surgery, surgeon-reported outcomes), oncological findings in case of malignancy (e.g., R0-resection rate, time to adjuvant treatment, survival), postoperative outcomes (e.g., clinically relevant complications), healthcare resource utilization (length of stay, readmissions, intensive care stay), quality of life, and costs. Postoperative follow-up is up to 36 months.

The DIPLOMA-2 trial aims to establish the safety of MIPD as the new standard of care for this selected patient population undergoing pancreatoduodenectomy in high-volume centers, ultimately aiming for superior patient recovery.

ISRCTN27483786. Registered on August 2, 2023.

Knowledge on adverse events in psychotherapy for youth with OCD is sparse. No official guidelines exist for defining or monitoring adverse events in psychotherapy. Recent recommendations call for more qualitative and quantitative assessment of adverse events in psychotherapy trials. This mixed methods study aims to expand knowledge on adverse events in psychotherapy for youth with OCD.

This is an analysis plan for a convergent mixed methods study within a randomized clinical trial (the TECTO trial). We include at least 128 youth aged 8-17 years with obsessive-compulsive disorder (OCD). Participants are randomized to either family-based cognitive behavioral therapy (FCBT) or family-based psychoeducation and relaxation training (FPRT). Adverse events are monitored quantitatively with the Negative Effects Questionnaire. Furthermore, we assess psychiatric symptoms, global functioning, quality of life, and family factors to investigate predictors for adverse events. We conduct semi-structured qualitative interviews with all youths and their parents on their experience of adverse events in FCBT or FPRT. For the mixed methods analysis, we will merge 1) a qualitative content analysis with descriptive statistics comparing the types, frequencies, and severity of adverse events; 2) a qualitative content analysis of the perceived causes for adverse events with prediction models for adverse events; and 3) a thematic analysis of the participants' treatment evaluation with a correlational analysis of adverse events and OCD severity.

The in-depth mixed methods analysis can inform 1) safer and more effective psychotherapy for OCD; 2) instruments and guidelines for monitoring adverse events; and 3) patient information on potential adverse events. The main limitation is risk of missing data.

ClinicalTrials.gov identifier: NCT03595098. Registered on July 23, 2018.

An increasing number of robotic pancreatoduodenectomies (RPD) are reported, however, questions remain on the number of procedures needed for gaining technical proficiency in RPD. Therefore, we aimed to assess the influence of procedure volume on short-term RPD outcomes and assess the learning curve effect.

A retrospective review of consecutive RPD cases was undertaken. Non-adjusted cumulative sum (CUSUM) analysis was performed to identify the procedure volume threshold, following which before-threshold and after-threshold outcomes were compared.

Since May 2017, 60 patients had undergone an RPD at our institution. The median operative time was 360 min (IQR 302.25-442 min). CUSUM analysis of operative time identified 21 cases as proficiency threshold, indicated by curve inflexion. Median operative time was significantly shorter after the threshold of 21 cases (470 vs 320 min, p < 0.001). No significant difference was found between before- and after-threshold groups in major Clavien-Dindo complications (23.8 vs 25.6%, p = 0.876).

A decrease in operative time after 21 RPD cases suggests a threshold of technical proficiency potentially associated with an initial adjustment to new instrumentation, port placement and standardisation of operative step sequence. RPD can be safely performed by surgeons with prior laparoscopic surgery experience.

ARA 290, an 11-amino acid linear nonhematopoietic peptide derived from the three-dimensional structure of helix B of the erythropoietin (EPO), interacts selectively with the innate repair receptor (IRR) that arbitrates tissue protection. The aim of this study was to investigate the protective effects of ARA290 against cisplatin-induced nephrotoxicity. For this purpose, HEK-293 and ACHN cells were treated with ARA290 (50-400 nM) and cisplatin (2.5 μM) in pretreatment condition. Then, cytotoxicity, genotoxicity, oxidative stress parameters (ROS, GPx, SOD, and MDA), and inflammatory markers (TNFα, IL6, and IL1β) were evaluated. Furthermore, apoptotic cell death was assessed via caspase-3 activity and tunnel assay. To determine the molecular mechanisms of the possible nephroprotective effects of ARA290, gene and protein expressions of TNFα, IL1β, IL6, Caspase-3, Bax, and Bcl2 were evaluated by real-time PCR and western blot assay, respectively. The findings indicated that ARA290 significantly reduced the DNA damage parameters of comet assay and the frequency of micronuclei induced by cisplatin. Besides, ARA290 improved cisplatin-induced oxidative stress by reducing MDA/ROS levels and enhancing antioxidant enzyme levels. In addition, reduced levels of pro-inflammatory cytokines indicated that cisplatin-induced renal inflammation was mitigated upon the treatment with ARA290. Besides, ARA290 ameliorates cisplatin-induced cell injury by antagonizing apoptosis. Furthermore, the molecular findings indicated that gene and protein levels of TNFα, IL1β, IL6, Caspase-3, and Bax were significantly decreased and gene and protein levels of Bcl2 significantly increased in the ARA290 plus cisplatin group compared with the cisplatin group. These findings revealed that ARA290 as a potent chemo-preventive agent exerted a protective effect on cisplatin-induced nephrotoxicity mostly through its anti-apoptotic, anti-inflammatory, and antioxidant potentials and also suggested that ARA290 might be a new therapeutic approach for patients with acute kidney injury.

To evaluate how operative time interacts with outcomes among different approaches to pancreaticoduodenectomy (PD). Minimally invasive PDs (MIPD), which include laparoscopic (LPD) and robotic (RPD) approaches, are increasingly performed in the USA. MIPD are generally associated with longer operative times (OT) compared to open PD (OPD). Increased OT is associated with inferior outcomes for OPD; however, the effect of OT on MIPD is not well understood.

National Surgical Quality Improvement Program (NSQIP)-targeted pancreatectomy dataset was utilized (2014-2019). Propensity score matching, logistic regression, and mixed effect modeling were performed to determine the effect of OT on outcomes following PD. OTs were stratified by quartiles for each approach, and outcomes were subsequently compared.

Among 23,988 PDs, 22,185 were OPD and 1803 MIPD. Increased OT was associated with greater overall morbidity in all approaches. When comparing OT quartiles, MIPD was consistently associated with improved overall morbidity compared to OPD in matched cohorts. However, for upper quartiles, prolonged OT in MIPD was associated with significantly increased reoperation rates and mortality. The effect of OT on overall morbidity and other outcomes was comparable among LPD and RPD.

In this study, increased OT was associated with incremental increases in overall morbidity after PD, irrespective of approach. While MIPD was associated with improved overall morbidity compared to OPD when stratified by OT quartile, higher mortality rates were observed with prolonged OT only with MIPD. Those data suggest that MIPD is a safe alternative to OPD when OT is optimized. NSQIP was used to compare the effect of operative time (OT) on outcomes following pancreaticoduodenectomy (PD), stratified by approach. Increased OT was associated with inferior outcomes following open, laparoscopic, and robotic PD. Surgeons should attempt to optimize OT, regardless of the approach to PD.

Young men in South Africa face the intersecting epidemics of HIV, substance use and endemic poverty. We tested the effectiveness of a behavioral intervention using soccer training to reduce the cluster of risks associated with HIV and substance use. This cluster randomized controlled trial was conducted with men aged 18-29 years old in 27 neighborhoods in the townships of Cape Town, South Africa. Neighborhoods were randomized to receive for 6 months either: (1) Soccer League (SL; n = 18 neighborhoods, n = 778 men) who attended soccer three times weekly (72 sessions; 94% uptake, 45.5% weekly attendance rate), combined with an HIV/substance use, cognitive-behavioral intervention; or (2) a Control Condition (CC; n = 9; 415 men) who received educational materials and referrals at 3 month intervals. The primary outcome was the number of significant changes in a cluster of outcomes including HIV-related risks, substance abuse, employment/income, mental health, violence, and community engagement. There was only one significant difference on the rapid diagnostic tests for mandrax at 6 months, an insufficient number of changes to indicate a successful intervention. A group-based behavioral intervention was ineffective in addressing multiple risk behaviors among at-risk young men, similar to the findings of several recent soccer-related interventions. Early adulthood may be too late to alter well-established patterns of risk behaviors.Clinical Trial Registration This trial was prospectively registered on 24 November 2014 with ClinicalTrials.gov NCT02358226.

Short peripheral catheterization is the common procedure performed in every hospital with patients' admittance. It becomes challenging when it comes to children and requires more knowledge and skills. The aim of the current study was to assess the effectiveness of the reinforcement program on adherence to short peripheral catheter (SPC) care guidelines among registered nurses.

A quasi-experimental study was conducted among 44 registered nurses by observing 96 SPC care events before and after the reinforcement program in pediatric wards of a tertiary care hospital in Eastern India. The study was conducted in a tertiary care public hospital in Eastern India in 2019, and the data collection tool included children's and nurses' socio-demographic data and an observation checklist on intravenous catheterization care. Descriptive statistics were used to explain the participant characteristics, and McNemar's test was used to identify the adherence to SPC care guidelines.

There was a statistically significant improvement in most steps, such as hand washing, gloving, tray preparation, documentation initiation, maintenance, and removal (P = 0.001). A statistically significant reduction in the early stage of phlebitis was found from 66.7% in pre-intervention to 37.5% in post-intervention (P = 0.027).

The majority of nurses adhered to SPC care guidelines after the reinforcement program. From the study findings, it is recommended that regular reinforcement related to peripheral catheter care acts as a stimulant to adhere to SPC care guidelines. The nursing administration should take initiative by conducting in-service training for the nurses, which motivates them toward practicing quality nursing care.

meaningful community engagement is increasingly being considered the major determinant of successful research, innovation and intervention uptake. Even though there is available literature recommending community engagement in health research, there are still knowledge gaps in how communities might be best engaged in Sub-Saharan Africa. We, therefore, synthesized the existing literature on the current practices, barriers and facilitators, ethical considerations, and gender mainstreaming in the engagement of communities in research in sub-Saharan Africa.

this synthesis was developed following the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA). A combination of keywords and medical subject headings was used to search MEDLINE, EMBASE, Global Health Library through OVID SP, the Cochrane Library, PsychINFO, CINAHL, WHO Afro Library, WHO Global Index Medicus and the National Institute for Health Research, for all literature published between 1 January 2000 to 31 July 2021.

thirty articles met our inclusion criteria. The key reported facilitators of effective community engagement in research included appropriate community entry and engagement of stakeholders. Barriers to effective community engagement in research included the availability of prohibitive cultural, historical and religious practices; geographical/spatial limitations, difficulties in planning and executing community engagement activities and communication barriers. Awareness creation and sensitization on the research through drama, social media, documentaries, and community durbars are some of the existing practices adopted in engaging communities in research. Gender mainstreaming was not considered appropriately in the engagement of communities in research, as only a few studies made provisions for gender considerations, and most of the time, interchanging gender for sex. Respect for autonomy, privacy and informed consent were the main ethical issues reported.

gender mainstreaming and ethical standards were reported as important, but not explored in depth. Gender as a social construct needs to be carefully integrated in the entire research cycle. Clear ethical concerns within a research project have to be co-discussed by the research team, community members and potential research participants.

App-based interventions have the potential to enhance access to and quality of care for patients with schizophrenia. However, less is known about the current state of schizophrenia apps in research and how those translate to publicly available apps. This study, therefore, aimed to review schizophrenia apps offered on marketplaces and research literature with a focus on accessibility and availability. A search of recent reviews, gray literature, PubMed, and Google Scholar was conducted in August 2022. A search of the U.S. Apple App Store and Google Play App Store was conducted in July 2022. All eligible studies and apps were systematically screened/reviewed. The academic research search produced 264 results; 60 eligible studies were identified. 51.7% of research apps were built on psychosis-specific platforms and 48.3% of research apps were built on non-specific platforms. 83.3% of research apps offered monitoring functionalities. Only nine apps, two designed on psychosis-specific platforms and seven on non-specific platforms were easily accessible. The search of app marketplaces uncovered 537 apps; only six eligible marketplace apps were identified. 83.3% of marketplace apps only offered psychoeducation. All marketplace apps lacked frequent updates with the average time since last update 1121 days. There are few clinically relevant apps accessible to patients on the commercial marketplaces. While research efforts are expanding, many research apps are unavailable today. Better translation of apps from research to the marketplace and a focus on sustainable interventions are important targets for the field.

Children hospitalised with severe anaemia in malaria-endemic areas are at a high risk of dying or being readmitted within six months of discharge. A trial in Kenya and Uganda showed that three months of postdischarge malaria chemoprevention (PDMC) with monthly dihydroartemisinin-piperaquine (DP) substantially reduced this risk. The World Health Organization recently included PDMC in its malaria chemoprevention guidelines. We conducted a cost-effectiveness analysis of community-based PDMC delivery (supplying all three PDMC-DP courses to caregivers at discharge to administer at home), facility-based PDMC delivery (monthly dispensing of PDMC-DP at the hospital), and the standard of care (no PDMC).

We combined data from two recently completed trials; one placebo-controlled trial in Kenya and Uganda collecting efficacy data (May 6, 2016 until November 15, 2018; n=1049), and one delivery mechanism trial from Malawi collecting adherence data (March 24, 2016 until October 3, 2018; n=375). Cost data were collected alongside both trials. Three Markov decision models, one each for Malawi, Kenya, and Uganda, were used to compute incremental cost-effectiveness ratios expressed as costs per quality-adjusted life-year (QALY) gained. Deterministic and probabilistic sensitivity analyses were performed to account for uncertainty.

Both PDMC strategies were cost-saving in each country, meaning less costly and more effective in increasing health-adjusted life expectancy than the standard of care. The estimated incremental cost savings for community-based PDMC compared to the standard of care were US$ 22·10 (Malawi), 38·52 (Kenya), and 26·23 (Uganda) per child treated. The incremental effectiveness gain using either PDMC strategy varied between 0·3 and 0·4 QALYs. Community-based PDMC was less costly and more effective than facility-based PDMC. These results remained robust in sensitivity analyses.

PDMC under implementation conditions is cost-saving. Caregivers receiving PDMC at discharge is a cost-effective delivery strategy for implementation in malaria-endemic southeastern African settings.

Research Council of Norway.

People living with mental illness have difficulty obtaining quality physical care services. Nurses find it hard to fully assume their role and adopt a person-centered approach when they care for people with both physical and mental health problems. A scoping review was carried out to document the breadth and depth of literature on nurse interventions designed to improve nursing care in general healthcare settings for adults living with mental illness. Two researchers independently screened titles, abstracts and full documents to obtain publications, and the relevant data was extracted from individual studies. Of the 384 studies identified, 16 documents were included in the study. Few interventions have been the subject of scientific publications and they are scattered in their objectives and very heterogeneous in their content. Interventions are often included in a large program that may be difficult to apply in various care settings. There are many different nursing roles and activities in care-management and in support of behavioral changes although their main measured outcomes differ. This study highlights a tendency for interventions to relegate people with mental health problems to specialized services, which reinforces the dichotomization of services and does not favor a holistic and person-centered approach. There is an urgent need to develop and evaluate nursing interventions in general healthcare settings for adults living with mental illness. The development of relevant continuing education and training must take into account both the point of view of the people living with mental illness and that of nurses.

There is no general consensus on the feasibility and safety of robotic pancreatoduodenectomy (RPD) and whether it increases surgical risks. The purpose of this study was to assess the safety, feasibility, and rationality of RPD by comparing perioperative data among open pancreatoduodenectomy (OPD), laparoscopic pancreatoduodenectomy (LPD), and RPD performed in our center in recent years.

Clinical data of patients had undergone RPD (n = 32), LPD (n = 21), and OPD (n = 86) in The First Affiliated Hospital of Guangxi Medical University between January 2016 and June 2020 were retrospectively collected and analyzed.

RPD required more time for operation (537.2 min vs. 441.5 min, p < 0.001) than OPD did, but less time to remove abdominal drainage tube (12.5 d vs. 17.3 d, p = 0.001). The differences between the RPD group and LPD group were interesting, as the two groups had similar operation time (537.2 min vs. 592.9 min, p = 1.000) and blood loss (482.8 ml vs. 559.5 ml, p > 0.05), but the RPD group had a higher activity of daily living score on postoperative day 3 (35.8 vs. 25.7, p = 0.0017) and a lower rate of conversion to OPD (6.5% vs. 38.1%, p = 0.011). Regarding complications, such as the postoperative pancreatic fistula, abdominal hemorrhage, intra-abdominal infection, bile leakage, reoperation, and perioperative mortality, there were no significant differences among the three groups.

Not only is RPD feasible and reliable, it also offers significant advantages in that it improves postoperative recovery of skills needed for everyday life, has a low conversion rate to open surgery, and does not increase surgical risks.

The number of interventions to improve recruitment and retention of participants in trials is rising, with a corresponding growth in randomised Studies Within Trials (SWATs) to evaluate their (cost-)effectiveness. Despite recognised challenges in conducting trials involving adults who lack capacity to consent, until now, no individual-level recruitment interventions have focused on this population. Following the development of a decision aid for family members making non-emergency trial participation decisions on behalf of people with impaired capacity, we have designed a SWAT to evaluate the decision aid in a number of host trials (CONSULT). Unlike in recruitment SWATs to date, the CONSULT intervention is aimed at a 'proxy' decision-maker (a family member) who is not a participant in the host trial and does not receive the trial intervention. This commentary explores the methodological and ethical considerations encountered when designing such SWATs, using the CONSULT SWAT as a case example. Potential solutions to address these issues are also presented.

We encountered practical issues around informed consent, data collection, and follow-up which involves linking the intervention receiver (the proxy) with recruitment and retention data from the host trial, as well as issues around randomisation level, resource use, and maintaining the integrity of the host trial. Unless addressed, methodological uncertainty about differential recruitment and heterogeneity between trial populations could potentially limit the scope for drawing robust inferences and harmonising data from different SWAT host trials. Proxy consent is itself ethically complex, and so when conducting a SWAT which aims to disrupt and enhance proxy consent decisions, there are additional ethical issues to be considered.

Designing a SWAT to evaluate a recruitment intervention for non-emergency trials with adults lacking capacity to consent has raised a number of methodological and ethical considerations. Explicating these challenges, and some potential ways to address them, creates a starting point for discussions about conducting these potentially more challenging SWATs. Increasing the evidence base for the conduct of trials involving adults lacking capacity to consent is intended to improve both the ability to conduct these trials and their quality, and so help build research capacity for this under-served population.

Three recent advances in the surgical approach to pancreatic cancer over the past decade have improved both short- and long-term outcomes for patients with nonmetastatic, operable pancreatic cancer. These include (1) minimally invasive pancreatectomy to reduce operative morbidity while adhering to principles of open oncologic resections, (2) neoadjuvant chemotherapy to treat radiographically occult metastatic disease and improve locoregional control, and (3) applying irreversible electroporation as an adjunct to surgery, allowing a fraction of locally advanced pancreatic cancer to be resected.