County characteristics and veteran suicide in the United States, 2011-2018.

INTRODUCTION: Few studies have examined county-level hotspots of veteran suicide and associated place-based contributors, limiting development of targeted community-level prevention strategies. The objectives of this national spatial analysis of all veteran suicides were to identify areas of the United States (U.S.) with higher-than-expected veteran suicide rates and determine county-level social and economic characteristics associated with areas of higher risk. METHODS: Using Bayesian hierarchical modeling, county-level standardized mortality ratios for veteran suicide deaths were estimated for time periods 2011-2018, 2011-2014, and 2015-2018. Adjusted relative risk, accounting for community characteristics, for each county was then estimated and associations between community characteristics and veteran suicide risk were examined. Analyses were conducted in 2023-2024. RESULTS: Risk of veteran suicide is predominantly concentrated in the Mountain West and West. Significant predictors of risk across all time periods were per capita number of firearm retailers (2011-2018 RR=1.065 [95%CI 1.030-1.102]), the proportion of residents who moved in the past year (2011-2018 RR=1.060 [95%CI 1.039-1.081]), the proportion of residents who live alone (2011-2018 RR=1.067 [95%CI 1.046-1.089]), the proportion of residents in rental housing (2011-2018 RR=1.041 [95%CI 1.018-1.065]), and the proportion of married residents (2011-2018 RR=0.915 [95%CI 0.890-0.941]). CONCLUSIONS: This study contributes to a comprehensive public health approach to veteran suicide prevention by identifying where resources are needed most, and which place-based intervention targets have the largest potential for impact. Findings suggest that public health efforts to address suicide among veterans should address community level firearm access and identify ways to alleviate deleterious effects of social fragmentation.

The effects of psychotherapy for anhedonia on subcortical brain volumes measured with ultra-high field MRI.

BACKGROUND: Anhedonia is a transdiagnostic symptom often resistant to treatment. The identification of biomarkers sensitive to anhedonia treatment will aid in the evaluation of novel anhedonia interventions. METHODS: This is an exploratory analysis of changes in subcortical brain volumes accompanying psychotherapy in a transdiagnostic anhedonic sample using ultra-high field (7-Tesla) MRI. Outpatients with clinically impairing anhedonia (n = 116) received Behavioral Activation Treatment for Anhedonia, a novel psychotherapy, or Mindfulness-Based Cognitive Therapy (ClinicalTrials.gov Identifiers NCT02874534 and NCT04036136). Subcortical brain volumes were estimated via the MultisegPipeline, and regions of interest were the amygdala, caudate nucleus, hippocampus, pallidum, putamen, and thalamus. Bivariate mixed effects models estimated pre-treatment relations between anhedonia severity and subcortical brain volumes, change over time in subcortical brain volumes, and associations between changes in subcortical brain volumes and changes in anhedonia symptoms. RESULTS: As reported previously (Cernasov et al., 2023), both forms of psychotherapy resulted in equivalent and significant reductions in anhedonia symptoms. Pre-treatment anhedonia severity and subcortical brain volumes were not related. No changes in subcortical brain volumes were observed over the course of treatment. Additionally, no relations were observed between changes in subcortical brain volumes and changes in anhedonia severity over the course of treatment. LIMITATIONS: This trial included a modest sample size and did not have a waitlist-control condition or a non-anhedonic comparison group. CONCLUSIONS: In this exploratory analysis, psychotherapy for anhedonia was not accompanied by changes in subcortical brain volumes, suggesting that subcortical brain volumes may not be a candidate biomarker sensitive to response to psychotherapy.

'The big value of it is getting the patient seen by the right person at the right time': clinician perceptions of the value of allied health primary contact models of care.

Allied health primary contact clinic models of care have increasingly been used as a strategy to increase public health service capacity. A recent systematic review found little consistency or agreement on how primary contact clinics are evaluated. The concept of value of primary contact clinics, which has important implications for evaluation, has not yet been explored in-depth. To explore allied health clinicians' perceptions of the value of allied health primary contact clinics, with the goal of informing an evaluation framework, a descriptive qualitative approach utilizing semi-structured interviews was employed. Participants included allied health staff embedded in clinical lead roles within primary contact clinics across four acute care hospitals in a metropolitan health service located in South-East Queensland, Australia. Lead staff from 30 identified primary contact clinic models in the health service were approached to take part via email. All eligible participants who provided consent were included. An inductive thematic analysis approach was used. A total of 23 clinicians (n = 23) representing 22 diverse models of primary contact clinics participated. Most participants were physiotherapists, dietitians, or occupational therapists, although speech pathology, audiology, and podiatry were also represented. Participant perceptions of the 'value' of PCCs were a highly complex phenomenon, comprising five intersecting domains: (i) patient satisfaction; (ii) clinical outcomes; (iii) care pathway and resource use; (iv) health service performance; and (v) staff satisfaction and professional standing. These five core value domains were positively or negatively influenced by 12 perceived benefits and 8 perceived drawbacks, respectively. Value domains were also highly interrelated and impacted upon each other. The concept of 'value' relating to primary contact clinics involves multiple intersecting domains encompassing different perspectives. This study highlighted potential benefits and drawbacks of primary contact clinics that have not yet been measured or explored in the literature, and as such may be useful for healthcare administrators to consider. The findings of this study will inform an evaluation framework including health economics calculator for primary contact clinics.

Compassion Meditation for Distressed Older Veterans: A Feasibility Study.

OBJECTIVES: Older Veterans are at elevated risk for psychological distress and may encounter barriers to accessing mental health services. Compassion Meditation (CM) promotes positive emotions and outcomes among distressed individuals; thus, we conducted a preliminary feasibility study of CM among distressed older Veterans. METHODS: Participants included 25 Veterans aged 55+ (M = 69.0, SD = 10.6) with anxiety and/or depressive symptoms, recruited from primary care, mostly male (76.0%), and White (60.0%). CM consisted of 10 groups, which were transitioned from in-person to telehealth due to COVID-19. Feasibility indices included rates of intervention initiation and completion, and attendance. Participants completed measures of symptom severity and well-being pre- and post-intervention. RESULTS: Of 25 enrolled participants, 88.0% (n = 22) attended at least one session, and 52% (n = 13) completed the intervention (attended six or more sessions). Among intervention completers, the average number of sessions attended was 9.46. Seven Veterans withdrew from intervention due to difficulties engaging via telehealth. CONCLUSIONS: These findings support the feasibility of CM training in older Veterans with psychological distress, though dropouts highlighted potential need for additional strategies to facilitate telehealth participation. CLINICAL IMPLICATIONS: Older Veterans appear amenable to meditation-based practices, provided they are easy to access.

Effect of Antibiotic Prophylaxis on Infection Rates in Pediatric Supracondylar Humerus Fractures Treated with Closed Reduction and Percutaneous Pinning: A Prospective Double-Blinded Randomized Controlled Trial.

BACKGROUND: Supracondylar humerus fractures (SCHFs) are the most common elbow fracture in the pediatric population. In the case of displaced fractures, closed reduction and percutaneous Kirschner wire pinning (CRPP) is commonly performed. Infection rates are between 0 and 7%; however, retrospective studies have shown no benefit of preoperative antibiotics. There continues to be notable variability in antibiotic usage based on surgeon preference and local institutional policy. We conducted a double-blinded, randomized controlled trial to evaluate whether antibiotic prophylaxis reduces the risk of infection in pediatric SCHF patients treated with CRPP. METHODS: Pediatric patients with displaced SCHF who presented to a pediatric hospital were enrolled and randomized into two groups. Group I received one dose of prophylactic antibiotics (25 mg/kg cefazolin IV up to 1g or clindamycin 10 mg/kg up to 600 mg/kg IV in the case of cefazolin allergy). Group II received placebo (10-mL prefilled syringe of normal saline). All patients underwent CRPP and casting followed by pin removal 3 to 6 weeks after the initial procedure. The presence of pin-site infection, erythema, drainage, septic arthritis, and osteomyelitis was recorded. RESULTS: One hundred sixty patients were enrolled in the study. Eighty-two patients were randomized to receive antibiotics, and 78 patients were randomized to placebo. No difference was seen in the rate of infection between the treatment groups (1.2% in the antibiotic group versus 1.3% in the placebo group; P = 1.00). Presence of purulent drainage (0.0% versus 1.3%; P = 0.49), septic arthritis (0.0% versus 0.0%; P = 1.00), and osteomyelitis (1.2% versus 0.0%; P = 1.00) was similar in both groups. No difference in the need for additional antibiotics (1.2% versus 1.3%; P = 1.00) or additional surgery (1.2% versus 0.0%; P = 1.00) was found between groups. DISCUSSION: The use of antibiotic prophylaxis did not affect the risk of infection in pediatric patients who underwent CRPP for displaced SCHF. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT03261830. LEVEL OF EVIDENCE: Therapeutic Level I.

Physical exercise to promote regeneration after peripheral nerve injury in animal models: A systematic review.

Peripheral nerve injuries are common injuries that often have a drastic effect on patient's activities of daily living and physical function. While techniques for the surgical repair of these injuries have improved over time, rehabilitation methods following these repairs have been non-standardized and under researched. Electronic searches were conducted in Ovid/Medline and SCOPUS to identify articles that discuss rehabilitation and exercise following peripheral nerve injury in animal models and its effects on peripheral nerve regeneration and recovery of function. Thirty-eight articles met inclusion criteria; all were prospective studies in animal models. This systematic review suggests that exercise is a useful tool in returning autonomy to the individual and has beneficial effects in the recovery from peripheral nerve injury. It is beneficial to use rehabilitation exercises following the repair of peripheral nerve injuries to promote regeneration, and timing of that exercise may be just as important as the exercise prescribed. However, further studies with standardized models and outcome measures need to be conducted before translation to clinical trials.

Neuromodulators can promote nerve regeneration and accelerate functional recovery after peripheral nerve injury: A systematic review.

Peripheral nerve injuries (PNIs) are debilitating injuries that are also challenging to treat. With several different techniques being investigated to optimize nerve regeneration, we performed this systematic review aiming to evaluate and synthesize the available peer-reviewed literature regarding PNIs and the research that has been done to optimize peripheral nerve regeneration. Two research databases were searched, and abstracts were reviewed for relevance. The abstracts that met screening criteria then underwent full-text review. Out of 6,128 unique citations, 164 publications were ultimately included in this review. Evidence supports many potential options for the management of PNIs, including surgical treatment and systemic and local administration of various pharmacological agents. Some of the reported benefits of treatment with such agents include faster nerve regeneration, improved functional recovery, neuroma prevention, and decreased scar formation. However, much of the research reviewed has been performed in animal models, not human trails. Additionally, the safety profile of some agents makes systemic treatment difficult. Further translational and clinical studies are needed to fill these remaining gaps in knowledge to make evidence-based recommendations regarding the most effective treatment for PNIs.

'Virtually daily grief'-understanding distress in health practitioners involved in a regulatory complaints process: a qualitative study in Australia.

Protection of the public is the paramount aim for health practitioner regulation, yet there has been growing concern globally on the association between regulatory complaints processes and practitioner mental health and wellbeing. The objective was to understand the experience, particularly distress, of health practitioners involved in a regulatory complaints process to identify potential strategies to minimise future risk of distress. Semi-structured qualitative interviews were conducted with health practitioners in Australia who had recently been through a regulatory complaints process, together with a retrospective analysis of documentation relating to all identified cases of self-harm or suicide of health practitioners who were involved in such a process over 4 years. Data from interviews and the serious incident analysis found there were elements of the regulatory complaints process contributing to practitioner distress. These included poor communication, extended time to close the investigation, and the management of health-related concerns. The study found external personal circumstances and pre-existing conditions could put the practitioner at greater risk of distress. There were found to be key moments in the process-triggers-where the practitioner was at particular risk of severe distress. Strong support networks, both personal and professional, were found to be protective against distress. Through process improvements and, where appropriate, additional support for practitioners, we hope to further minimise the risk of practitioner distress and harm when involved in a regulatory complaints process. The findings also point to the need for improved partnerships between regulators and key stakeholders, such as legal defence organisations, indemnity providers, employers, and those with lived experience of complaints processes. Together they can improve the support for practitioners facing a complaint and address the stigma, shame, and fear associated with regulatory complaints processes. This project provides further evidence that a more compassionate approach to regulation has the potential to be better for all parties and, ultimately, the wider healthcare system.

Substantial improvement in short-term pain following carpal tunnel surgery for patients with moderate preoperative electromyography findings is diminished with diabetes and smoking.

Purpose: Carpal tunnel syndrome is a common orthopedic diagnosis that often benefits from surgical intervention. There is limited published data analyzing the correlation of smoking and diabetes with the outcomes of open carpal tunnel release, specifically with pain perception and electrophysiology results. The purpose of this study is to determine if smoking and diabetes affect preoperative pain perception in patients with carpal tunnel syndrome when correlated with EMG findings and to determine the differences in pain relief obtained 2 weeks post-operatively in this population. Methods: Following IRB approval, the authors conducted a retrospective chart review of consecutive patients who underwent open carpal tunnel release from January 1, 2019, to June 30, 2022, by a single surgeon at an academic hospital. Demographic information was collected. Pre- and 2-week postoperative VAS pain scores and the severity of disease assessed by EMG preoperatively were recorded. Subgroup analysis was performed, and patients were further stratified by preoperative EMG result into mild, moderate, and severe cohorts. Results: Patients who smoked compared to non-smokers had an average improvement in VAS of 2.1 versus 2.8. Patients with reported diabetes compared to non-diabetics had an average improvement in VAS of 2.3 versus VAS of 2.7. Patients who smoked and had diabetes compared to non-smoking, non-diabetic patients reported a change in VAS of 1.92 compared to 2.6. Subgroup analysis of patients with moderate EMG findings demonstrated that patients with diabetes had significantly less improvement in VAS compared to patients without diabetes and smokers had significantly less improvement in VAS compared to non-smokers. Conclusion: This study showed that among the subgroup of patients with moderate preoperative EMG findings, there was more improvement in pain following carpal tunnel release in non-diabetic patients compared to diabetic patients, and among non-smokers compared to smokers. This study is useful when counseling patients on confounding factors that affect 2-week postoperative recovery.

Dry Wrist Arthroscopy: Technique and Rationale.

Wrist arthroscopy has been established as a useful, minimally invasive tool for diagnosing and treating many different wrist conditions. The standard portals are located on the dorsum of the hand and wrist and are named for their relation to the extensor compartments. They include the radiocarpal and midcarpal portals. The radiocarpal portals are 3-4, 4-5, 6R, 6U, and 1-2. The midcarpal portals are STT (scaphotrapeziotrapezoidal), MCR (midcarpal radial), and MCU (midcarpal ulnar). Traditionally, wrist arthroscopy is performed with constant inflow of saline solution for joint insufflation and visualization. Dry wrist arthroscopy (DWA) is a technique that allows for arthroscopic exploration and instrumentation without infusing any fluid into the joints. Some advantages of DWA include lack of fluid extravasation, less obstruction by floating synovial villi, decreased risk of compartment syndrome, and the ability to perform concomitant open procedures more easily than with a wet technique. Additionally, the risk of fluid displacing carefully laid bone graft is much less without constant flow. DWA can be used in the assessment and management of triangular fibrocartilage complex (TFCC) and scapholunate interosseous ligament tears and other ligamentous injuries. DWA can also be used in fracture fixation to assist with reduction and restoration of articular surfaces. Moreover, it is used in more chronic settings to diagnose scaphoid nonunions. DWA does have its disadvantages such as generation of heat through the use of burrs and shavers and clogging of these instruments during debridement of tissue. DWA is a technique that can be used to manage multiple orthopaedic conditions including soft-tissue and osseous injuries. With a minimal learning curve for surgeons who already perform wrist arthroscopy, DWA can be a useful addition to their practice.

Study protocol: the ILANA study - exploring optimal implementation strategies for long-acting antiretroviral therapy to ensure equity in clinical care and policy for women, racially minoritised people and older people living with HIV in the UK - a qualitative multiphase longitudinal study design.

INTRODUCTION: Cabotegravir and rilpivirine (CAB+RPV long-acting (LA)) is recommended as a treatment for HIV-1 allowing people living with HIV to receive 2 monthly injectable treatment, rather than daily pills. Providing injectable therapy in a system designed to provide and manage study participants on oral treatments poses logistical challenges namely how resources are used to accommodate patient preference within constrained health economies with capacity limitations. In this pragmatic multicentre study, we aim to understand the implementation of CAB-RPV-LA administration in two settings via mixed methods to explore perspectives of participants and the clinical team delivering CAB+RPV LA. METHODS AND ANALYSIS: Women, racially minoritised people and older people are chronically under-represented in HIV clinical trials so the ILANA trial has set recruitment caps to ensure recruitment of 50% women, 50% ethnically diverse people and 30% over 50 years of age to include a more representative study population. Using a mixed-methods approach, the primary objective is to identify and evaluate the critical implementation strategies for CAB+RPV LA in both hospital and community settings. Secondary objectives include evaluating feasibility and acceptability of CAB+RPV LA administration at UK clinics and community settings from the perspective of HIV care providers, nurses and representatives at community sites, evaluating barriers to implementation, the utility of implementation strategies and adherence. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Health Research Authority Research Ethics Committee (REC reference: 22/PR/0318). The dissemination strategy has been formulated with the SHARE Collaborative Community Advisory Board to maximise the impact of this work on clinical care and policy. This strategy draws on and leverages existing resources within the participating organisations, such as their academic infrastructure, professional relationships and community networks. The strategy will leverage the Public Engagement Team and press office to support dissemination of findings. TRIAL REGISTRATION NUMBER: NCT05294159.

Cost-minimization analysis of oral versus intravenous antibiotic treatment for Klebsiella pneumoniae liver abscess.

A cost-minimization analysis was conducted for Klebsiella pneumoniae liver abscess (KLA) patients enrolled in a randomized controlled trial which found oral ciprofloxacin to be non-inferior to intravenous (IV) ceftriaxone in terms of clinical outcomes. Healthcare service utilization and cost data were obtained from medical records and estimated from self-reported patient surveys in a non-inferiority trial of oral ciprofloxacin versus IV ceftriaxone administered to 152 hospitalized adults with KLA in Singapore between November 2013 and October 2017. Total costs were evaluated by category and payer, and compared between oral and IV antibiotic groups over the trial period of 12 weeks. Among the subset of 139 patients for whom cost data were collected, average total cost over 12 weeks was $16,378 (95% CI, $14,620-$18,136) for the oral ciprofloxacin group and $20,569 (95% CI, $18,296-$22,842) for the IV ceftriaxone group, largely driven by lower average outpatient costs, as the average number of outpatient visits was halved for the oral ciprofloxacin group. There were no other statistically significant differences, either in inpatient costs or in other informal healthcare costs. Oral ciprofloxacin is less costly than IV ceftriaxone in the treatment of Klebsiella liver abscess, largely driven by reduced outpatient service costs.Trial registration: ClinicalTrials.gov Identifier NCT01723150 (7/11/2012).

Obesity Severity Predicts Patient Dissatisfaction After Total Knee Arthroplasty.

BACKGROUND: Patient dissatisfaction has been reported in 15 to 20% of traditional total knee arthroplasty (TKA) procedures. While contemporary improvements may have positive effects on patient satisfaction, these may be offset by increasing obesity prevalence among patients who have knee osteoarthritis. We performed this study to determine whether obesity severity impacts patient-reported TKA satisfaction. METHODS: We compared patient demographic characteristics, preoperative expectations, preoperative and minimum 1-year postoperative patient-reported outcome measures as well as postoperative satisfaction level among 229 patients (243 TKAs) who had World Health Organization (WHO) Class II or III obesity (group A), and 287 patients (328 TKAs) who had WHO classifications of normal weight, overweight, or Class I obesity (group B). RESULTS: Group A patients were younger and had more severe preoperative back and contralateral knee pain, more frequent preoperative opioid medication use, and lower preoperative and postoperative patient-reported outcome measures (P < .01). A similar proportion of patients in both groups expected at least 75% improvement (68.5 versus 73.2%, P = .27). While satisfaction was higher than traditional reporting for both groups (89.4 versus 92.6%, P = .19), group A patients were less likely to be highly satisfied (68.1 versus 78.5%, P = .04) and were more likely to be highly dissatisfied (5.1 versus 0.9%, P < .01). CONCLUSIONS: Patients who have Class II and III obesity report greater TKA dissatisfaction. Additional studies should help determine whether specific implant designs or surgical techniques may improve patient satisfaction or whether preoperative counseling should incorporate lower satisfaction expectations for patients who have WHO Class II or III obesity.

Striatal dopamine in anhedonia: A simultaneous [11C]raclopride positron emission tomography and functional magnetic resonance imaging investigation.

BACKGROUND: Anhedonia is hypothesized to be associated with blunted mesocorticolimbic dopamine (DA) functioning in samples with major depressive disorder. The purpose of this study was to examine linkages between striatal DA, reward circuitry functioning, anhedonia, and, in an exploratory fashion, self-reported stress, in a transdiagnostic anhedonic sample. METHODS: Participants with (n = 25) and without (n = 12) clinically impairing anhedonia completed a reward-processing task during simultaneous positron emission tomography and magnetic resonance (PET-MR) imaging with [11C]raclopride, a DA D2/D3 receptor antagonist that selectively binds to striatal DA receptors. RESULTS: Relative to controls, the anhedonia group exhibited decreased task-related DA release in the left putamen, caudate, and nucleus accumbens and right putamen and pallidum. There were no group differences in task-related brain activation (fMRI) during reward processing after correcting for multiple comparisons. General functional connectivity (GFC) findings revealed blunted fMRI connectivity between PET-derived striatal seeds and target regions in the anhedonia group. Associations were identified between anhedonia severity and the magnitude of task-related DA release to rewards in the left putamen, but not mesocorticolimbic GFC. CONCLUSIONS: Results provide evidence for reduced striatal DA functioning during reward processing and blunted mesocorticolimbic network functional connectivity in a transdiagnostic sample with clinically significant anhedonia.

Parsing within & between-person dynamics of therapy homework completion and clinical symptoms in two cognitive behavioral treatments for adults with anhedonia.

OBJECTIVE: Homework is a key theoretical component of cognitive-behavioral therapies, however, the effects of homework on clinical outcomes have largely been evaluated between-persons rather than within-persons. METHODS: The effects of homework completion on treatment response were examined in a randomized trial comparing Behavioral Activation Treatment for Anhedonia (BATA, n = 38), a novel psychotherapy, to Mindfulness-Based Cognitive Therapy (MBCT, n=35). The primary endpoint was consummatory reward sensitivity, measured weekly by the Snaith Hamilton Pleasure Scale (SHAPS), up to 15 weeks. Multilevel models evaluated change in SHAPS scores over time and the effects of clinician-reported and participant-reported homework. RESULTS: BATA and MBCT resulted in significant, equivalent reductions in SHAPS scores. Unexpectedly, participants who completed greater mean total amounts of homework did not improve at a faster rate (i.e., no between-person effect). However, sessions with greater than average participant-reported homework completion were associated with greater than average reductions in SHAPS scores (i.e., a within-person effect). For clinician-reported homework, this effect was only evident within the BATA condition. CONCLUSION: This study shows psychotherapy homework completion relates to symptomatic improvement in cognitive-behavioral treatments for anhedonia when session-to-session changes are examined within-person. On the contrary, we found no evidence that total homework completion predicted greater improvements between-person. When possible, psychotherapy researchers should evaluate their constructs of interest across multiple sessions (not just pre/post) to allow more direct tests of hypotheses predicted by theoretical models of individual change processes.

Fluid Optimisation in Emergency Laparotomy (FLO-ELA) Trial: study protocol for a multi-centre randomised trial of cardiac output-guided fluid therapy compared to usual care in patients undergoing major emergency gastrointestinal surgery.

INTRODUCTION: Postoperative morbidity and mortality in patients undergoing major emergency gastrointestinal surgery are a major burden on healthcare systems. Optimal management of perioperative intravenous fluids may reduce mortality rates and improve outcomes from surgery. Previous small trials of cardiac-output guided haemodynamic therapy algorithms in patients undergoing gastrointestinal surgery have suggested this intervention results in reduced complications and a modest reduction in mortality. However, this existing evidence is based mainly on elective (planned) surgery, with little evaluation in the emergency setting. There are fundamental clinical and pathophysiological differences between the planned and emergency surgical setting which may influence the effects of this intervention. A large definitive trial in emergency surgery is needed to confirm or refute the potential benefits observed in elective surgery and to inform widespread clinical practice. METHODS: The FLO-ELA trial is a multi-centre, parallel-group, open, randomised controlled trial. 3138 patients aged 50 and over undergoing major emergency gastrointestinal surgery will be randomly allocated in a 1:1 ratio using minimisation to minimally invasive cardiac output monitoring to guide protocolised administration of intra-venous fluid, or usual care without cardiac output monitoring. The trial intervention will be carried out during surgery and for up to 6 h postoperatively. The trial is funded through an efficient design call by the National Institute for Health and Care Research Health Technology Assessment (NIHR HTA) programme and uses existing routinely collected datasets for the majority of data collection. The primary outcome is the number of days alive and out of hospital within 90 days of randomisation. Participants and those delivering the intervention will not be blinded to treatment allocation. Participant recruitment started in September 2017 with a 1-year internal pilot phase and is ongoing at the time of publication. DISCUSSION: This will be the largest contemporary randomised trial examining the effectiveness of perioperative cardiac output-guided haemodynamic therapy in patients undergoing major emergency gastrointestinal surgery. The multi-centre design and broad inclusion criteria support the external validity of the trial. Although the clinical teams delivering the trial interventions will not be blinded, significant trial outcome measures are objective and not subject to detection bias. TRIAL REGISTRATION: ISRCTN 14729158. Registered on 02 May 2017.

Economic evaluation of an integrated virtual care programme for people with chronic illness who are frequent users of health services in Australia.

OBJECTIVE: The MeCare programme is a tailored virtual care initiative targeted at frequent users of health services who have at least one chronic condition including cardiovascular disease, chronic respiratory disease, diabetes or chronic kidney disease. The programme aims to prevent unnecessary hospitalisations by helping patients to self-manage, improve their health literacy and engage in positive health behaviours. This study investigates the impact of the MeCare programme on healthcare resource use, costs and patient-reported outcomes. METHODS AND ANALYSIS: A retrospective pre-post study design was adopted. Data on emergency department presentations, hospital admissions, outpatient appointments and their associated costs were obtained from administrative databases. Probabilistic sensitivity analysis using Monte Carlo simulation was used to model changes in resource use and costs prior to, and following, participant enrolment on the MeCare programme. Generalised linear models were used to investigate the observed changes in patient-reported outcomes. RESULTS: The MeCare programme cost $A624 per participant month to deliver. Median monthly rates of ED presentations, hospital admissions and average length of stay post-MeCare reduced by 76%, 50% and 12%, respectively. This translated to a median net cost saving of $A982 per participant month (IQR: -1936; -152). A significant, positive trend in patient experience based on responses to the Patient Assessment of Care for Chronic Conditions Questionnaire was observed over the duration of programme enrolment. DISCUSSION: The MeCare programme is likely to result in substantial cost savings to the health system, while maintaining or improving patient-reported outcomes. Further research in multisite randomised studies is needed to confirm the generalisability of these results.

CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomized trials.

Randomized controlled trials remain the reference standard for healthcare research on effects of interventions, and the need to report both benefits and harms is essential. The Consolidated Standards of Reporting Trials (the main CONSORT) statement includes one item on reporting harms (i.e., all important harms or unintended effects in each group). In 2004, the CONSORT group developed the CONSORT Harms extension; however, it has not been consistently applied and needs to be updated. Here, we describe CONSORT Harms 2022, which replaces the CONSORT Harms 2004 checklist, and shows how CONSORT Harms 2022 items could be incorporated into the main CONSORT checklist. Thirteen items from the main CONSORT were modified to improve harms reporting. Three new items were added. In this article, we describe CONSORT Harms 2022 and how it was integrated into the main CONSORT checklist and elaborate on each item relevant to complete reporting of harms in randomized controlled trials. Until future work from the CONSORT group produces an updated checklist, authors, journal reviewers, and editors of randomized controlled trials should use the integrated checklist presented in this paper.