Effects of Actissist, a digital health intervention for early psychosis: A randomized clinical trial.

Schizophrenia affects 24 million people worldwide. Digital health interventions drawing on psychological principles have been developed, but their effectiveness remains unclear. This parallel, assessor-blinded, randomized clinical trial aimed to investigate whether a cognitive behaviour therapy-informed digital health intervention (Actissist app) confers added benefit on psychotic symptoms over and above remote symptom monitoring (ClinTouch app). Participants recruited from UK community health services were randomized 1:1 to receive either Actissist plus treatment as usual (TAU) or ClinTouch plus TAU. Eligible participants were adults with schizophrenia-spectrum psychosis within five years of first episode onset meeting a criterion level of positive symptoms severity. The primary outcome was Positive and Negative Syndrome Scale (PANSS) symptoms total score at 12 weeks post-randomization. Intention-to-treat analysis included 172 participants, with 149 participants (86.6 %) providing primary outcome data. Actissist plus TAU was not associated with greater reduction than an active control remote symptom monitoring app (ClinTouch) in PANSS total score at post-randomization. There were no significant effects between groups across secondary measures. There were no serious adverse reactions. Both groups improved on the primary psychotic symptoms measure at primary end-point and on secondary measures over time. The Actissist app is safe but not superior to digital symptom monitoring.

A Core Outcome Set for Intact Abdominal Aortic Aneurysm Repair.

OBJECTIVE: Technology and advances in clinical care have changed the management of abdominal aortic aneurysms (AAAs) but the clinical effectiveness of continuing advances needs to be assessed. To facilitate rapid synthesis of new evidence and improve stakeholder representation, including patients, the concept of core outcome sets (COS) has been developed. COS, reflecting the needs of all stakeholders, have been established across several surgical specialties. This study aimed to develop an international core outcome set for intact AAA repair. METHODS: Following COMET methodology, potential outcomes were identified from a systematic review of published outcomes and focus groups involving patients, carers, and nurses. A 38 question Delphi consensus survey in lay language was developed (with translation to local languages); this included 35 themes identified from the findings of the systematic review and three themes from the focus groups. All three of the themes identified by the focus groups (cognitive, physical, and social functioning) can be evaluated from quality of life instruments, with overall quality of life being identified from the systematic review. The survey was completed by patients, carers or family members, vascular nurses, vascular surgeons, trainees, interventional radiologists, anaesthetists, and industry partners from six European countries. After two rounds of the survey, the top outcomes were discussed at a face to face multistakeholder consensus meeting. RESULTS: The 38 item questionnaire was amended after piloting among all stakeholder groups. After the first round of the Delphi survey (98 respondents) 15 questions were eliminated, and 11 further questions were eliminated after round 2 (90 respondents). This left two outcome questions for discussion at the consensus meeting, where the top six outcomes were unanimously endorsed: death at 30 days (or in hospital if longer), secondary AAA rupture, overall quality of life and retention of cognitive functioning after recovery, five year survival, and continued sac growth. CONCLUSION: Six core outcomes are recommended for use as a minimum framework in all future studies and registries of intact open and endovascular AAA repair. Further work to select instruments for quality of life and to define instruments for cognitive functioning is needed.

Implementing and Evaluating a National Integrated Digital Registry and Clinical Decision Support System in Early Intervention in Psychosis Services (Early Psychosis Informatics Into Care): Co-Designed Protocol.

BACKGROUND: Early intervention in psychosis (EIP) services are nationally mandated in England to provide multidisciplinary care to people experiencing first-episode psychosis, which disproportionately affects deprived and ethnic minority youth. Quality of service provision varies by region, and people from historically underserved populations have unequal access. In other disease areas, including stroke and dementia, national digital registries coupled with clinical decision support systems (CDSSs) have revolutionized the delivery of equitable, evidence-based interventions to transform patient outcomes and reduce population-level disparities in care. Given psychosis is ranked the third most burdensome mental health condition by the World Health Organization, it is essential that we achieve the same parity of health improvements. OBJECTIVE: This paper reports the protocol for the program development phase of this study, in which we aimed to co-design and produce an evidence-based, stakeholder-informed framework for the building, implementation, piloting, and evaluation of a national integrated digital registry and CDSS for psychosis, known as EPICare (Early Psychosis Informatics into Care). METHODS: We conducted 3 concurrent work packages, with reciprocal knowledge exchange between each. In work package 1, using a participatory co-design framework, key stakeholders (clinicians, academics, policy makers, and patient and public contributors) engaged in 4 workshops to review, refine, and identify a core set of essential and desirable measures and features of the EPICare registry and CDSS. Using a modified Delphi approach, we then developed a consensus of data priorities. In work package 2, we collaborated with National Health Service (NHS) informatics teams to identify relevant data currently captured in electronic health records, understand data retrieval methods, and design the software architecture and data model to inform future implementation. In work package 3, observations of stakeholder workshops and individual interviews with representative stakeholders (n=10) were subject to interpretative qualitative analysis, guided by normalization process theory, to identify factors likely to influence the adoption and implementation of EPICare into routine practice. RESULTS: Stage 1 of the EPICare study took place between December 2021 and September 2022. The next steps include stage 2 building, piloting, implementation, and evaluation of EPICare in 5 demonstrator NHS Trusts serving underserved and diverse populations with substantial need for EIP care in England. If successful, this will be followed by stage 3, in which we will seek NHS adoption of EPICare for rollout to all EIP services in England. CONCLUSIONS: By establishing a multistakeholder network and engaging them in an iterative co-design process, we have identified essential and desirable elements of the EPICare registry and CDSS; proactively identified and minimized potential challenges and barriers to uptake and implementation; and addressed key questions related to informatics architecture, infrastructure, governance, and integration in diverse NHS Trusts, enabling us to proceed with the building, piloting, implementation, and evaluation of EPICare. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/50177.

Evaluating pharmacological THRomboprophylaxis in Individuals undergoing superficial endoVEnous treatment across NHS and private clinics in the UK: a multi-centre, assessor-blind, randomised controlled trial-THRIVE trial.

INTRODUCTION: Endovenous therapy is the first choice management for symptomatic varicose veins in NICE guidelines, with 56-70 000 procedures performed annually in the UK. Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a known complication of endovenous therapy, occurring at a rate of up to 3.4%. Despite 73% of UK practitioners administering pharmacological thromboprophylaxis to reduce VTE, no high-quality evidence supporting this practice exists. Pharmacological thromboprophylaxis may have clinical and cost benefit in preventing VTE; however, further evidence is needed. This study aims to establish whether when endovenous therapy is undertaken: a single dose or course of pharmacological thromboprophylaxis alters the risk of VTE; pharmacological thromboprophylaxis is associated with an increased rate of bleeding events; pharmacological prophylaxis is cost effective. METHODS AND ANALYSIS: A multi-centre, assessor-blind, randomised controlled trial (RCT) will recruit 6660 participants from 40 NHS and private sites across the UK. Participants will be randomised to intervention (single dose or extended course of pharmacological thromboprophylaxis plus compression) or control (compression alone). Participants will undergo a lower limb venous duplex ultrasound scan at 21-28 days post-procedure to identify asymptomatic DVT. The duplex scan will be conducted locally by blinded assessors. Participants will be contacted remotely for follow-up at 7 days and 90 days post-procedure. The primary outcome is imaging-confirmed lower limb DVT with or without symptoms or PE with symptoms within 90 days of treatment. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, using a repeated measures analysis of variance, adjusting for any pre-specified strongly prognostic baseline covariates using a mixed effects logistic regression. ETHICS AND DISSEMINATION: Ethical approval was granted by Brent Research Ethics Committee (22/LO/0261). Results will be disseminated in a peer-reviewed journal and presented at national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN18501431.

Applying Team Science to Collaborative Digital Health Research: Learnings from the Wearable Clinic.

Collaboration across disciplinary boundaries is vital to address the complex challenges and opportunities in Digital Health. We present findings and experiences of applying the principles of Team Science to a digital health research project called 'The Wearable Clinic'. Challenges faced were a lack of shared understanding of key terminology and concepts, and differences in publication cultures between disciplines. We also encountered more profound discrepancies, relating to definitions of "success" in a research project. We recommend that collaborative digital health research projects select a formal Team Science methodology from the outset.

An Updated Systematic Review and Meta-analysis of the Impact of Graduated Compression Stockings in Addition to Pharmacological Thromboprophylaxis for Prevention of Venous Thromboembolism in Surgical Inpatients.

OBJECTIVE: To compare the rate of venous thromboembolism (VTE) in surgical inpatients with pharmacological thromboprophylaxis and additional graduated compression stockings (GCSs) versus pharmacological thromboprophylaxis alone. BACKGROUND: Surgical inpatients have elevated VTE risk; recent studies cast doubt on whether GCS confers additional protection against VTE, compared with pharmacological thromboprophylaxis alone. METHODS: The review followed "Preferred Reporting Items for Systematic Reviews and Meta-analyses" guidelines using a registered protocol (CRD42017062655). The MEDLINE and Embase databases were searched up to November 2022. Randomized trials reporting VTE rate after surgical procedures, utilizing pharmacological thromboprophylaxis, with or without GCS, were included. The rates of deep venous thrombosis (DVT), pulmonary embolism, and VTE-related mortality were pooled through fixed and random effects. RESULTS: In a head-to-head meta-analysis, the risk of DVT for GCS and pharmacological thromboprophylaxis was 0.85 (95% CI: 0.54-1.36) versus for pharmacological thromboprophylaxis alone (2 studies, 70 events, 2653 participants). The risk of DVT in pooled trial arms for GCS and pharmacological thromboprophylaxis was 0.54 (95% CI: 0.23-1.25) versus pharmacological thromboprophylaxis alone (33 trial arms, 1228 events, 14,108 participants). The risk of pulmonary embolism for GCS and pharmacological prophylaxis versus pharmacological prophylaxis alone was 0.71 (95% CI: 0.0-30.0) (27 trial arms, 32 events, 11,472 participants). There were no between-group differences in VTE-related mortality (27 trial arms, 3 events, 12,982 participants). CONCLUSIONS: Evidence from head-to-head meta-analysis and pooled trial arms demonstrates no additional benefit for GCS in preventing VTE and VTE-related mortality. GCS confer a risk of skin complications and an economic burden; current evidence does not support their use for surgical inpatients.

Systematic Review and Meta-Analysis of Elective Open Conversion versus Fenestrated and Branched Endovascular Repair for Previous Non-Infected Failed Endovascular Aneurysm Repair.

OBJECTIVE: To evaluate outcomes of patients electively undergoing fenestrated and branched endovascular repair (F/B-EVAR) or open conversion for failed previous non-infected endovascular aneurysm repair (EVAR). DATA SOURCES: Embase, MEDLINE, Cochrane Library. REVIEW METHOD: The protocol was prospectively registered on PROSPERO (CRD42023404091). The review followed the PRISMA guidelines; certainty was assessed through the GRADE and quality through MINORS tools. Outcomes data were pooled separately for F/B-EVAR and open conversion. A random effects meta-analysis of proportions was conducted; heterogeneity was assessed with the I2 statistic. RESULTS: Thirty eight studies were included, for a total of 1 645 patients of whom 1 001 (60.9%) underwent an open conversion and 644 (39.1%) a F/B-EVAR. The quality of evidence was generally limited. GRADE certainty was judged low for 30 day death (in both groups) and F/B-EVAR technical success, and very low for the other outcomes. Pooled 30 day death was 2.3% (I2 33%) in the open conversion group and 2.4% (I2 0%) in the F/B-EVAR conversion group (p = .36). Technical success for F/B-EVAR was 94.1% (I2 23%). The pooled 30 day major systemic complications rate was higher in the open conversion (21.3%; I2 74%) than in the F/B-EVAR (15.7%; I2 78%) group (p = .52). At 18 months follow up, the pooled re-intervention rate was 4.5% (I2 58%) in the open conversion and 26% (I2 0%) in the F/B-EVAR group (p < .001), and overall survival was 92.5% (I2 59%) and 81.6% (I2 68%), respectively (p = .005). CONCLUSION: In the elective setting, and excluding infections, the early results of both open conversion and F/B-EVAR after failed EVAR appear satisfactory. Although open conversion presented with higher complication rates in the first 30 days after surgery, at follow up it seemed to be associated with fewer re-interventions and better survival compared with F/B-EVAR.

Quantifying the effects of risk-stratified breast cancer screening when delivered in real time as routine practice versus usual screening: the BC-Predict non-randomised controlled study (NCT04359420).

BACKGROUND: Risk stratification as a routine part of the NHS Breast Screening Programme (NHSBSP) could provide a better balance of benefits and harms. We developed BC-Predict, to offer women when invited to the NHSBSP, which collects standard risk factor information; mammographic density; and in a sub-sample, a Polygenic Risk Score (PRS). METHODS: Risk prediction was estimated primarily from self-reported questionnaires and mammographic density using the Tyrer-Cuzick risk model. Women eligible for NHSBSP were recruited. BC-Predict produced risk feedback letters, inviting women at high risk (≥8% 10-year) or moderate risk (≥5-<8% 10-year) to have appointments to discuss prevention and additional screening. RESULTS: Overall uptake of BC-Predict in screening attendees was 16.9% with 2472 consenting to the study; 76.8% of those received risk feedback within the 8-week timeframe. Recruitment was 63.2% with an onsite recruiter and paper questionnaire compared to <10% with BC-Predict only (P < 0.0001). Risk appointment attendance was highest for those at high risk (40.6%); 77.5% of those opted for preventive medication. DISCUSSION: We have shown that a real-time offer of breast cancer risk information (including both mammographic density and PRS) is feasible and can be delivered in reasonable time, although uptake requires personal contact. Preventive medication uptake in women newly identified at high risk is high and could improve the cost-effectiveness of risk stratification. TRIAL REGISTRATION: Retrospectively registered with clinicaltrials.gov (NCT04359420).

Meta-analysis of lytic catheter-based intervention for acute proximal deep vein thrombosis in the reduction of post-thrombotic syndrome.

OBJECTIVE: Post-thrombotic syndrome (PTS) is a common complication of deep vein thrombosis (DVT) that can result in significant morbidity for the patient with detrimental impact on their quality of life. Evidence supporting lytic catheter-based interventions (LCBI) undertaken for early thrombus reduction in acute proximal DVT for the prevention of PTS is conflicting. Despite this, rates of LCBIs are increasing. To summaries the existing evidence and pool treatment effects, a meta-analysis of randomized controlled trials assessing the efficacy of LCBIs in proximal acute DVT for the prevention of PTS was undertaken. METHODS: This meta-analysis was undertaken aligning with PRISMA guidelines following a protocol pre-registered on PROSPERO. Online searches of Medline and Embase databases, as well as the gray literature, were performed up to December 2022. Included articles were randomized controlled trials that studied the use of LCBIs with additional anticoagulation vs anticoagulation alone and had determined follow-up periods. Outcomes of interest were PTS development, moderate to severe PTS, major bleeding episodes, and quality-of-life measures. Subgroup analyses were performed for DVTs involving the iliac vein and/r common femoral vein. Meta-analysis was performed using a fixed effects model. Quality assessment was performed using the Cochrane Risk of Bias and GRADE assessment tools. RESULTS: Three trials were included in the final meta-analysis, the Post-thrombotic Syndrome after Catheter-directed Thrombolysis for Deep Vein Thrombosis (CaVenT), Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT), and Ultrasound-accelerated Catheter-directed Thrombolysis Versus Anticoagulation for the Prevention of Post-thrombotic Syndrome (CAVA) trials, comprising 987 patients. Patients undergoing LCBIs had a reduced risk of PTS (relative risk [RR], 0.84; 95% confidence interval [CI], 0.74-0.95; P = .006) and a lower risk of developing moderate to severe PTS (RR, 0.75; 95% CI, 0.58-0.97; P = .03). LBCIs increased the risk of having a major bleed (RR, 2.03; 95% CI, 1.08-3.82; P = .03). In the iliofemoral DVT subgroup analysis, there was a trend toward decreasing the risk of developing PTS and moderate to severe PTS (P = .12 and P = .05, respectively). There was no significant difference in quality-of-life score (as measured by the Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms) between the two groups (P = .51). CONCLUSIONS: Pooling of current best evidence suggests that LCBIs in acute proximal DVT decreases the rate of PTS and moderate to severe PTS with a number needed to treat of 12 and 18, respectively. However, this is complicated by a significantly higher rate of major bleeding with a number needed to treat of 37. This evidence supports the use of LCBIs in selected patients, including those who are at low risk of major bleeding.

A Digital Intervention to Improve Mental Health and Interpersonal Resilience in Young People Who Have Experienced Technology-Assisted Sexual Abuse: Protocol for a Nonrandomized Feasibility Clinical Trial and Nested Qualitative Study.

BACKGROUND: No evidence-based support has been offered to young people (YP) who have experienced technology-assisted sexual abuse (TASA). Interventions aimed at improving mentalization (the ability to understand the mental states of oneself and others) are increasingly being applied to treat YP with various clinical issues. Digital technology use among YP is now common. A digital intervention aimed at improving mentalization in YP who have experienced TASA may reduce the risk of revictimization and future harm and make YP more resilient and able to manage distress that might result from TASA experiences. OBJECTIVE: In this paper, we describe a protocol for determining the feasibility of the i-Minds trial and the acceptability, safety, and usability of the digital intervention (the i-Minds app) and explore how to best integrate i-Minds into existing routine care pathways. METHODS: This is a mixed methods nonrandomized study aimed to determine the feasibility, acceptability, safety, and usability of the intervention. Participants aged between 12 and 18 years who report distress associated with TASA exposure will be recruited from the United Kingdom from the National Health Service (NHS) Trust Child and Adolescent Mental Health Services, sexual assault referral centers, and a web-based e-therapy provider. All participants will receive the i-Minds app for 6 weeks. Coproduced with YP and a range of stakeholders, the i-Minds app focuses on 4 main topics: mentalization, TASA and its impact, emotional and mental health, and trauma. A daily prompt will encourage YP to use the app, which is designed to be used in a stand-alone manner alongside routine care. We will follow participants up after the intervention and conduct interviews with stakeholders to explore the acceptability of the app and trial procedures and identify areas for improvement. Informed by the normalization process theory, we will examine barriers and enablers relevant to the future integration of the intervention into existing care pathways, including traditional clinic-based NHS and NHS e-therapy providers. RESULTS: This study was approved by the Research Ethics Board of Scotland. We expect data to be collected from up to 60 YP. We expect to conduct approximately 20 qualitative interviews with participants and 20 health care professionals who referred YP to the study. The results of this study have been submitted for publication. CONCLUSIONS: This study will provide preliminary evidence on the feasibility of recruiting YP to a trial of this nature and on the acceptability, safety, and usability of the i-Minds app, including how to best integrate it into existing routine care. The findings will inform the decision to proceed with a powered efficacy trial. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number Registry (ISRCTN) ISRCTN43130832; https://www.isrctn.com/ISRCTN43130832. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40539.

Exploring engagement with the CBT-informed Actissist smartphone application for early psychosis.

BACKGROUND: Individuals with psychosis report favourable attitudes towards psychological interventions delivered via smartphone apps. Evidence for acceptability, safety, feasibility and efficacy is promising but in-depth reporting of app engagement in trials is sparse. AIMS: To examine how people with psychosis engaged with the cognitive behaviour therapy (CBT)-informed Actissist app over a 12-week intervention period, and to examine factors associated with app engagement. METHODS: Secondary data from participants in the intervention arm (n = 24) of a proof-of-concept randomised controlled trial of the Actissist app were analysed. The app prompted participants to engage with app-based CBT-informed material in five domains (voices, socialization, cannabis use, paranoia, perceived criticism) at pseudo-random intervals (three notifications per day, six days per week). Participants could self-initiate use any time. App use was financially incentivised. RESULTS: Participants responded to 47% of app notifications. Most app engagements (87%) were app-initiated rather than self-initiated. Participants engaged most with the voices domain, then paranoia. Age and employment status were significantly associated with overall app engagement. CONCLUSION: Individuals with psychosis engaged well with Actissist, particularly with areas focussing on voice-hearing and paranoia. App-generated reminders successfully prompted app engagement. As financial incentives may have increased app engagement, future studies of non-incentivized engagement in larger samples are needed.

Examining the benefit of graduated compression stockings in the prevention of hospital-associated venous thromboembolism in low-risk surgical patients: a multicentre cluster randomised controlled trial (PETS trial).

INTRODUCTION: Hospital-acquired thrombosis (HAT) is defined as any venous thromboembolism (VTE)-related event during a hospital admission or occurring up to 90 days post discharge, and is associated with significant morbidity, mortality and healthcare-associated costs. Although surgery is an established risk factor for VTE, operations with a short hospital stay (<48 hours) and that permit early ambulation are associated with a low risk of VTE. Many patients undergoing short-stay surgical procedures and who are at low risk of VTE are treated with graduated compression stockings (GCS). However, evidence for the use of GCS in VTE prevention for this cohort is poor. METHODS AND ANALYSIS: A multicentre, cluster randomised controlled trial which aims to determine whether GCS are superior in comparison to no GCS in the prevention of VTE for surgical patients undergoing short-stay procedures assessed to be at low risk of VTE. A total of 50 sites (21 472 participants) will be randomised to either intervention (GCS) or control (no GCS). Adult participants (18-59 years) who undergo short-stay surgical procedures and are assessed as low risk of VTE will be included in the study. Participants will provide consent to be contacted for follow-up at 7-days and 90-days postsurgical procedure. The primary outcome is the rate of symptomatic VTE, that is, deep vein thrombosis or pulmonary embolism during admission or within 90 days. Secondary outcomes include healthcare costs and changes in quality of life. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, measured at an individual level, using hierarchical (multilevel) logistic regression. ETHICS AND DISSEMINATION: Ethical approval was granted by the Camden and Kings Cross Research Ethics Committee (22/LO/0390). Findings will be published in a peer-reviewed journal and presented at national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN13908683.

Shared Decision Making and the Management of Intact Abdominal Aortic Aneurysm: A Scoping Review of the Literature.

OBJECTIVE: The aim of this study was to summarise the current knowledge of shared decision making (SDM) in patients facing a treatment decision about an intact abdominal aortic aneurysm (AAA), and to identify where further evidence is needed. DATA SOURCES: MEDLINE, Embase, and the Cochrane Library were searched on 18 July 2021. An updated search was run on 31 May 2022 for relevant studies published from 1 January 2000 to 31 May 2022. REVIEW METHODS: This scoping review was undertaken in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines following a pre-defined protocol, retrieving studies reporting on aspects of SDM in those with intact AAAs. Qualitative synthesis of the articles was performed, and the results grouped according to theme. RESULTS: Fifteen articles reporting on a total of 1 344 participants (age range 62-74 years) from hospital vascular surgery clinics with intact AAAs were included. Studies were observational (n = 9), non-randomised studies of an intervention (n = 3), and randomised clinical trials (n = 3). The first theme was the preferences and practice of SDM. The proportion of patients preferring SDM ranged from 58% to 95% (three studies), although objective rating of SDM practice was consistently < 50% (three studies). Clinician training improved SDM practice. The second theme was poor provision of information. Fewer than half of patients (0 - 46%) surveyed were informed about all available treatment options (three studies). Publicly available information sources were rated as poor. The third theme concerned the utility of decision making support tools (DSTs). Two randomised trials demonstrated that the provision of DSTs improves patient knowledge and agreement between patient preference and repair type received but not objective measures of SDM for patients with AAAs. CONCLUSION: SDM for patients with an intact AAA appears to be in its infancy. Most patients with an AAA want SDM, but this is not commonly applied. Most patients with an AAA do not receive adequate information for SDM, although the use of bespoke DSTs leaves patients better informed to facilitate SDM.

Developing Core Outcome Sets for Vascular Conditions Across Europe, Not as Easy as It Sounds.

Introduction: Most of the outcomes reported in the literature have been chosen by doctors, constituting "traditional" outcome measures such as mortality and re-intervention. Some of the key outcome measures important to patients, families, health providers and other stakeholders may have been overlooked. Core outcome sets, consisting of 6-15 outcomes, can improve representation of all key stakeholders, standardise outcome reporting, and improve future ability to pool results. The aim of this study was to outline the methods and challenges of conducting European core outcome sets. Report: As an overview, development of core outcome sets follows a multistep iterative process: (1) Systematic review of the literature summarising existing outcome measures, (2) Focus Group meeting with patients and other stakeholders to establish missing outcome measures, (3) Development and piloting of Delphi survey, (4) Delphi consensus study for prioritisation of outcomes and establishing consensus, and (5) European consensus meeting to produce a core outcome set. The challenges include the varying ethical requirements for survey work across Europe and translation for surveys and consensus meetings. Discussion: There is an increasing need for core outcome sets to complement clinical practice guidelines. As a European vascular community we need to produce these through collaborative efforts. Unfortunately, there are considerable barriers to doing so - the time and energy required to set up a core outcome study is not dissimilar to that of a multicentre randomised trial. Currently only one core outcome set exists for vascular surgery, for critical limb ischaemia, but this was developed in a single country.

Systematic Review and Meta-Analysis of the Pooled Rate of Post-Thrombotic Syndrome After Isolated Distal Deep Venous Thrombosis.

OBJECTIVE: To identify the rate of post-thrombotic syndrome (PTS) after isolated distal deep venous thrombosis (IDDVT) by performing a meta-analysis of the rate of PTS across randomised and observational studies. DATA SOURCES: MEDLINE, Embase, the Cochrane Controlled Trials Register, Clinicaltrials.gov, European Union Clinical Trials, International Standard Randomised Controlled Trial Number, and the Australian and New-Zealand Trials Registries. REVIEW METHODS: This review followed PRISMA guidelines using a registered protocol (CRD42021282136). Databases were searched up to December 2021 and prospective studies reporting the development of post-thrombotic syndrome were included; these were pooled with the meta-analysis. RESULTS: The results showed a post-thrombotic rate of 17% (95% CI 11 - 26%) (seven studies, 217 cases, 1 105 participants). Heterogeneity was high (I2 = 89%). On meta-regression, the rate of post-thrombotic syndrome was not correlated with the length of follow up (p = .71). Three studies (302 participants) reported the severity of post-thrombotic syndrome: 78% were mild (Villalta score 5 - 9); 11% were moderate (Villalta score 10 - 14), and 11% were severe (Villalta score ≥ 15). CONCLUSION: The risk of post-thrombotic syndrome after IDDVT was one in five and the risk of severe clinical manifestations, including ulceration, was one in 50. There was significant clinical, methodological, and statistical heterogeneity between studies and a substantial risk of bias from pooled studies. Randomised trials to support interventions for prevention of post-thrombotic syndrome are urgently needed.

Systematic review and meta-analysis of exercise therapy for venous leg ulcer healing and recurrence.

OBJECTIVE: National guidelines in the United Kingdom have recommended regular exercise for individuals with venous leg ulceration. However, data on the effects of exercise on ulcer healing and recurrence are sparse. In the present study, we aimed to quantify the evidence for exercise regarding venous ulcer healing with respect to the primary outcomes of the proportion of healed ulcers and rate of ulcer recurrence. The secondary outcomes were improvement in ulcer symptoms, ulcer healing time, quality of life, compliance, and adverse events reported. METHODS: The review followed PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines using a registered protocol (CRD42021220925). The MEDLINE and Embase databases and Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, European Union Clinical Trials, and International Standard Randomised Controlled Trial Number registries were searched up to April 6, 2022 and included studies comparing exercise therapy and compression vs compression alone. Data for the proportion of healed ulcers were pooled using a fixed effects meta-analysis. RESULTS: After screening 1046 reports, 7 were included, with 121 participants allocated to exercise therapy and 125 to compression alone. All the reports were of randomized controlled trials and had reported ulcer healing at 12 weeks, with a pooled relative risk of ulcer healing of 1.38 for exercise vs compression (95% confidence interval, 1.11-1.71). Only one study had reported on recurrence; thus, data pooling was not performed. No differences between exercise and usual care were demonstrated. Compliance with exercise ranged from 33% to 81%. The included studies demonstrated low enrollment and a high risk of bias. Also, most of the trials had failed to demonstrate any differences in activity completed between the intervention and control arms. CONCLUSIONS: A paucity of studies has examined leg ulcer recurrence after exercise programs, with no evidence to show that exercise is beneficial. Furthermore, the quality of evidence supporting exercise as an adjunct to ulcer healing is very low, and the trials demonstrated serious methodologic flaws, chiefly in recording the activity undertaken by the participants in the intervention arm. Future randomized controlled trials should implement activity monitoring and standardize the reporting of key patient, ulcer, and reflux characteristics to enable future meaningful meta-analyses to determine the role of exercise as an adjunct to venous leg ulceration healing.

Systematic Review and Meta-analysis of the Additional Benefit of Pharmacological Thromboprophylaxis for Endovenous Varicose Vein Interventions.

OBJECTIVE: The primary objective of this systematic review and meta-analysis was to elucidate the rate of venous thromboembolism (VTE) after endovenous interventions for varicose veins in the presence of pharmacological and mechanical thromboprophylaxis versus mechanical thromboprophylaxis alone. BACKGROUND: The VTE rate after endovenous procedures for varicose veins is higher than other day-case procedures and could be reduced with pharmacological thromboprophylaxis. METHODS: The review followed Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines with a registered protocol (PROSPERO: CRD42021274963). Studies of endovenous intervention for superficial venous incompetence reporting the predefined outcomes with at least 30 patients were eligible. Data were pooled with a fixed effects model. RESULTS: There were 221 trials included in the review (47 randomized trial arms, 105 prospective cohort studies, and 69 retrospective studies). In randomized trial arms, the rate of deep venous thrombosis with additional pharmacological thromboprophylaxis was 0.52% (95% CI, 0.23%-1.19%) (9 studies, 1095 patients, 2 events) versus 2.26% (95% CI, 1.81%-2.82%) (38 studies, 6951 patients, 69 events) with mechanical thromboprophylaxis alone. The rate of pulmonary embolism in randomized trial arms with additional pharmacological thromboprophylaxis was 0.45% (95% CI, 0.09-2.35) (5 studies, 460 participants, 1 event) versus 0.23% (95% CI, 0.1%-0.52%) (28 studies, 4834 participants, 3 events) for mechanical measures alone. The rate of EHIT grade III to IV was 0.35% (95% CI, 0.09-1.40) versus 0.88% (95% CI, 0.28%-2.70%). There was 1 VTE-related mortality and 1 instance of major bleeding, with low rates of minor bleeding. CONCLUSIONS: There is a significant reduction in the rate of DVT with additional pharmacological thromboprophylaxis and routine prescription of anticoagulation after endovenous varicose vein intervention should be considered. VTE risk for individual study participants is heterogeneous and risk stratification in future randomized interventional studies is critical to establish the clinical effectiveness and safety of additional pharmacological thromboprophylaxis.

Systematic review of exercise therapy in the management of post-thrombotic syndrome.

OBJECTIVES: Exercise improves haemodynamic parameters in patients with chronic venous disease. There is a paucity of evidence on its effect in post-thrombotic syndrome (PTS). The aim of this systematic review is to assess the impact of exercise in PTS. METHODS: Adhering to PRISMA guidelines and following PROSPERO registration (CRD42021220924), MEDLINE, Cochrane Library, EMBASE database, and trial registries were searched on 19th May 2022. RESULTS: One article met the inclusion criteria and a narrative synthesis was carried out. The included randomised controlled trial reported a between-group mean difference of 4.6 points (p = .027) in the VEINES-QOL score and -2.0 points (p = .14) in the Villalta score, in favour of exercise therapy. The statistical significance threshold was not reached. CONCLUSION: Data on exercise in PTS remains sparse but exercise appears to be a safe intervention. In the context of this literature, a potential future trial and outcome reporting measures are suggested.

Acceptability of reducing sedentariness using a mobile-phone application based on 'if then' plans for people with psychosis: A focus-group study conducted in North West England, UK.

OBJECTIVE: To understand the acceptability of (a) reducing sedentary-behaviour in people with psychosis using 'if-then' plans and (b) the proposed app content. DESIGN: Qualitative acceptability study. METHOD: Three structured focus-groups and an interview were conducted with eight participants who had experience of a psychotic episode. They discussed sedentary-behaviour, being more active, critical situations in which they may be tempted to be sedentary and solutions to these (the if-then plans), and a mock-up of the mobile application. The Theoretical Framework of Acceptability (TFA) was used to analyse qualitatively the transcripts. RESULTS: All TFA constructs were coded in each of the transcripts. The idea of reducing sedentary-behaviour was acceptable to people with psychosis, participants knew the importance of being more active, however it is not always their main priority. Likewise, the proposed content of the app was found to be acceptable, with participants already using some of the proposed solutions. CONCLUSION: This was the first study to use the TFA framework to assess the acceptability of an app that uses critical situations and solutions ('if-then plans') to help reduce sedentary behaviour for people with psychosis. In this sample (male, English speaking mainly white people), participants understood the benefits of being more active. However, reducing sedentary-behaviour is not the main priority of this population and being sedentary has benefits when their mental-health is bad.