Is socioeconomic deprivation associated with worse quality of life, anxiety and depression in liver transplant recipients? A cross-sectional study in a national transplantation programme.

OBJECTIVE: To identify whether socioeconomic deprivation is associated with worse health-related quality of life (HR-QoL), anxiety and depression following liver transplantation. DESIGN: Cross-sectional study. SETTING AND PARTICIPANTS: Liver transplant recipients within a national transplantation programme. METHODS: Participants completed the condition-specific 'Short Form of Liver Disease Quality of Life' Questionnaire, the Generalised Anxiety Disorder-7 (GAD-7) Questionnaire and the Patient Health Questionnaire-9 (PHQ-9). The aggregate HR-QoL Score (range 0-100) was derived, and multivariable linear regression was performed based on sociodemographic and clinical variables to estimate its independent association with Scottish Index of Multiple Deprivation (SIMD) quintiles. The GAD-7 Questionnaire and PHQ-9 were used to screen respondents for anxiety and depression, and multivariable logistic regression was performed to estimate their independent association with SIMD quintiles. RESULTS: Some 331 patients completed the questionnaires. Quintiles were equally distributed in the cohort, with no significant differences observed in underlying patient characteristics. Following multivariable adjustment, greater socioeconomic deprivation was associated with lower post-transplantation HR-QoL scores, with a difference of 9.7 points (95% CI: 4.6 to 14.9, p<0.001) between the most and least deprived quintiles. Recipients living in areas of least deprivation were less likely to suffer from anxiety (OR 0.05, 95% CI: 0.00 to 0.28, p=0.003) or depression (OR 0.13, 95% CI: 0.02 to 0.56, p=0.009). CONCLUSION: Despite the highly selected nature of liver transplant recipients, those living in the most deprived areas have a significantly lower HR-QoL and are more likely to suffer from anxiety and depression.

Readiness for implementation of novel digital health interventions for postoperative monitoring: a systematic review and clinical innovation network analysis.

An increasing number of digital health interventions (DHIs) for remote postoperative monitoring have been developed and evaluated. This systematic review identifies DHIs for postoperative monitoring and evaluates their readiness for implementation into routine health care. Studies were defined according to idea, development, exploration, assessment, and long-term follow-up (IDEAL) stages of innovation. A novel clinical innovation network analysis used coauthorship and citations to examine collaboration and progression within the field. 126 DHIs were identified, with 101 (80%) being early stage innovations (IDEAL stage 1 and 2a). None of the DHIs identified had large-scale routine implementation. There is little evidence of collaboration, and there are clear omissions in the evaluation of feasibility, accessibility, and the health-care impact. Use of DHIs for postoperative monitoring remains at an early stage of innovation, with promising but generally low-quality supporting evidence. Comprehensive evaluation within high-quality, large-scale trials and real-world data are required to definitively establish readiness for routine implementation.

Studying the Long-term Impact of COVID-19 in Kids (SLICK). Healthcare use and costs in children and young people following community-acquired SARS-CoV-2 infection: protocol for an observational study using linked primary and secondary routinely collected healthcare data from England, Scotland and Wales.

INTRODUCTION: SARS-CoV-2 infection rarely causes hospitalisation in children and young people (CYP), but mild or asymptomatic infections are common. Persistent symptoms following infection have been reported in CYP but subsequent healthcare use is unclear. We aim to describe healthcare use in CYP following community-acquired SARS-CoV-2 infection and identify those at risk of ongoing healthcare needs. METHODS AND ANALYSIS: We will use anonymised individual-level, population-scale national data linking demographics, comorbidities, primary and secondary care use and mortality between 1 January 2019 and 1 May 2022. SARS-CoV-2 test data will be linked from 1 January 2020 to 1 May 2022. Analyses will use Trusted Research Environments: OpenSAFELY in England, Secure Anonymised Information Linkage (SAIL) Databank in Wales and Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 in Scotland (EAVE-II). CYP aged ≥4 and <18 years who underwent SARS-CoV-2 reverse transcription PCR (RT-PCR) testing between 1 January 2020 and 1 May 2021 and those untested CYP will be examined.The primary outcome measure is cumulative healthcare cost over 12 months following SARS-CoV-2 testing, stratified into primary or secondary care, and physical or mental healthcare. We will estimate the burden of healthcare use attributable to SARS-CoV-2 infections in the 12 months after testing using a matched cohort study of RT-PCR positive, negative or untested CYP matched on testing date, with adjustment for confounders. We will identify factors associated with higher healthcare needs in the 12 months following SARS-CoV-2 infection using an unmatched cohort of RT-PCR positive CYP. Multivariable logistic regression and machine learning approaches will identify risk factors for high healthcare use and characterise patterns of healthcare use post infection. ETHICS AND DISSEMINATION: This study was approved by the South-Central Oxford C Health Research Authority Ethics Committee (13/SC/0149). Findings will be preprinted and published in peer-reviewed journals. Analysis code and code lists will be available through public GitHub repositories and OpenCodelists with meta-data via HDR-UK Innovation Gateway.

Development stage of novel digital health interventions for postoperative monitoring: protocol of a systematic review.

Introduction: The postoperative period represents a time where patients are at a high-risk of morbidity, which warrants effective surveillance. While digital health interventions (DHIs) for postoperative monitoring are promising, a coordinated, standardized and evidence-based approach regarding their implementation and evaluation is currently lacking. This study aimed to identify DHIs implemented and evaluated in postoperative care to highlight research gaps and assess the readiness for routine implementation. Methods: A systematic review will be conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to identify studies describing the implementation and evaluation of DHIs for postoperative monitoring published since 2000 (PROSPERO ID: CRD42021264289). This will encompass the Embase, Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Web of Science and ClinicalTrials.gov databases, and manual search of bibliographies for relevant studies and gray literature. Methodological reporting quality will be evaluated using the Idea, Development, Exploration, Assessment and Long-term Follow-up (IDEAL) reporting guideline relevant to the IDEAL stage of the study, and risk of bias will be assessed using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) framework. Data will be extracted according to the WHO framework for monitoring and evaluating DHIs, and a narrative synthesis will be performed. Discussion: This review will assess the readiness for implementation of DHIs for routine postoperative monitoring and will include studies describing best practice from service changes already being piloted out of necessity during the COVID-19 pandemic. This will identify interventions with sufficient evidence to progress to the next IDEAL stage, and promote standardized and comprehensive evaluation of future implementational studies.

A Qualitative Exploration of Nutrition Screening, Assessment and Oral Support Used in Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries.

Preoperative undernutrition is a prognostic indicator for postoperative mortality and morbidity. Evidence suggests that treating undernutrition can improve surgical outcomes. This study explored the provision of nutritional screening, assessment and support on surgical cancer wards in low- and middle-income countries (LMICs). This was a qualitative study and participants took part in one focus group or one individual interview. Data were analysed thematically. There were 34 participants from Ghana, India, the Philippines and Zambia: 24 healthcare professionals (HCPs) and 10 patients. Results showed that knowledge levels and enthusiasm were high in HCPs. Barriers to adequate nutritional support were a lack of provision of ward and kitchen equipment, food and sustainable nutritional supplements. There was variation across countries towards nutritional screening and assessment which seemed to be driven by resources. Many hospitals where resources were scarce focused on the care of individual patients in favour of an integrated systems approach to identify and manage undernutrition. In conclusion, there is scope to improve the efficiency of nutritional management of surgical cancer patients in LMICs through the integration of nutrition assessment and support into routine hospital policies and procedures, moving from case management undertaken by interested personnel to a system-based approach including the whole multidisciplinary team.

Real-time assessment of COVID-19 impact on global surgical case volumes.

Importance: The COVID-19 pandemic has disrupted global surgical capacity. The impact of the pandemic in low and middle income countries has the potential to worsen already strained access to surgical care. Timely assessment of surgical volumes in these countries remains challenging. Objective: To determine whether usage data from a globally used anesthesiology calculator mobile application can serve as a proxy for global surgical case volume and contribute to monitoring of the impact of the COVID-19 pandemic, particularly in World Bank low income countries where official data collection is not currently practical. Design: Subset of data from an ongoing observational cohort study of users of the application collected from October 1, 2018 to April 18, 2020. Setting: The mobile application is available from public sources; users download and use the application per their own clinical needs on personal mobile devices. Participants: No user data was excluded from the study. Exposures: Events with impacts on surgical case volumes, including weekends, holidays, and the COVID-19 pandemic. Main Outcomes and Measures: It was previously noted that application usage was decreased on weekends and during winter holidays. We subsequently hypothesized that more detailed analysis would reveal impacts of country-specific or region-specific holidays on the volume of app use. Results: 4,300,975 data points from 92,878 unique users were analyzed. Physicians and other anesthesia providers comprised 85.8% of the study population. Application use was reduced on holidays and weekends and correlated with fluctuations in surgical volume. The COVID-19 pandemic was associated with substantial reductions in app use globally and regionally. There was strong cross correlation between COVID-19 case count and reductions in app use. By country, there was a median global reduction in app use to 58% of baseline (interquartile range, 46%-75%). Application use in low-income continues to decline but in high-income countries has stabilized. Conclusions and Relevance: Application usage metadata provides a real-time indicator of surgical volume. This data may be used to identify impacted regions where disruptions to surgical care are disproportionate or prolonged. A dashboard for continuous visualization of these data has been deployed.

Can a smartphone-delivered tool facilitate the assessment of surgical site infection and result in earlier treatment? Tracking wound infection with smartphone technology (TWIST): protocol for a randomised controlled trial in emergency surgery patients.

INTRODUCTION: National data suggest that surgical site infection (SSI) complicates 2%-10% of general surgery cases, although the patient-reported incidence is much higher. SSIs cause significant patient morbidity and represent a significant burden on acute healthcare services, in a cohort predominantly suitable for outpatient management. Over three-quarters of UK adults now own smartphones, which could be harnessed to improve access to care. We aim to investigate if a smartphone-delivered wound assessment tool results in earlier treatment. METHODS AND ANALYSIS: This is a randomised controlled trial aiming to recruit 500 patients across National Health Service (NHS) hospitals. All emergency abdominal surgery patients over the age of 16 who own smartphones will be considered eligible, with the exclusion of those with significant visual impairment. Participants will be randomised in a 1:1 ratio between standard postoperative care and the intervention - use of the smartphone tool in addition to standard postoperative care. The main outcome measure will be time-to-diagnosis of SSI with secondary outcome measures considering use of emergency department and general practitioner services and patient experience. Follow-up will be conducted by clinicians blinded to group allocation. Analysis of time-to-diagnosis will be by comparison of means using an independent two sample t-test. ETHICS AND DISSEMINATION: This is the first randomised controlled trial on the use of a smartphone-delivered wound assessment tool to facilitate the assessment of SSI and the impact on time-to-diagnosis. The intervention is being used in addition to standard postoperative care. The study design and protocol were reviewed and approved by Southeast Scotland Research and Ethics Committee (REC Ref: 16/SS/0072 24/05/2016). Study findings will be presented at academic conferences, published in peer-reviewed journals and are expected in 2020. A written lay summary will be available to study participants on request. TRIAL REGISTRATION NUMBER: NCT02704897; Pre-results.

Assessment of available evidence in the management of gallbladder and bile duct stones: a systematic review of international guidelines.

BACKGROUND: Gallstone disease is a frequent disorder in the Western world with a prevalence of 10-20%. Recommendations for the assessment and management of gallstones vary internationally. The aim of this systematic review was to assess quality of guideline recommendations for treatment of gallstones. METHODS: PubMed, EMBASE and websites of relevant associations were systematically searched. Guidelines without a critical appraisal of literature were excluded. Quality of guidelines was determined using the AGREE II instrument. Recommendations without consensus or with low level of evidence were considered to define problem areas and clinical research gaps. RESULTS: Fourteen guidelines were included. Overall quality of guidelines was low, with a mean score of 57/100 (standard deviation 19). Five of 14 guidelines were considered suitable for use in clinical practice without modifications. Ten recommendations from all included guidelines were based on low level of evidence and subject to controversy. These included major topics, such as definition of symptomatic gallstones, indications for cholecystectomy and intraoperative cholangiography. CONCLUSION: Only five guidelines on gallstones are evidence-based and of a high quality, but even in these controversy exists on important topics. High quality evidence is needed in specific areas before an international guideline can be developed and endorsed worldwide.

Energy Expenditure After Liver Resection: Validation of a Mobile Device for Estimating Resting Energy Expenditure and an Investigation of Energy Expenditure Change After Liver Resection.

BACKGROUND: Resting energy expenditure (REE) is the major component of total energy expenditure. REE is traditionally performed by indirect calorimetry (IC) and is not well investigated after liver surgery. A mobile device (SenseWear Armband [SWA]) has been validated when estimating REE in other clinical settings but not liver resection. The aims of this study are to validate SWA vs IC, quantify REE change following liver resection, and determine factors associated with REE change. MATERIALS AND METHODS: Patients listed for open liver resection prospectively underwent IC and SWA REE recordings pre- and postoperatively. In addition, the SWA was worn continuously postoperatively to estimate daily REE for the first 5 postoperative days. To determine acceptability of the SWA, validation analysis was performed. To assess REE change, peak postoperative REE was compared with preoperative levels. Factors associated with REE change were also analyzed. RESULTS: SWA showed satisfactory validity compared with IC when estimating REE, although postoperatively, the 95% levels of agreement (-5.56 to 3.18 kcal/kg/d) may introduce error. Postoperative REE (median, 23.5 kcal/kg/d; interquartile range [IQR], 22.6-25.7 kcal/kg/d) was significantly higher than predicted REE (median, 19.7 kcal/kg/d; IQR, 19.1-21.0 kcal/kg/d; P < .0001). Median REE rise was 11% (IQR, -1% to 25%). Factors associated with REE rise of >11% were age ( P = .017) and length of operation ( P = .03). CONCLUSIONS: SWA offers a suitable alternative to IC when estimating postoperative REE, but the magnitude of the error (8.74 kcal/kg/d) could hinder its accuracy. REE quantification after liver resection is important to identify patients who could be prone to energy imbalance and therefore malnutrition.

Decision modeling in donation after circulatory death liver transplantation.

Donation after circulatory death (DCD) liver allografts are increasingly used for transplantation. However, the posttransplantation clinical and quality of life outcomes of DCD recipients are traditionally considered to be inferior compared with donation after brain death (DBD) allograft recipients. Decision making for such marginal organs can be difficult. This study investigated the optimal decision to accept or decline a DCD liver allograft for a patient based on their current health. A Markov decision process model was constructed to predict the 5-year clinical course of patients on the liver transplant waiting list. Clinical outcomes were determined from the UK transplant registry or appropriate literature. Quality-adjusted life years (QALYs) were determined using the condition-specific short form of liver disease quality of life (SF-LDQoL) questionnaire. There were 293/374 (78.3%) eligible patients who completed the SF-LDQoL questionnaire. A total of 73 respondents (24.9%) were before transplant and 220 were after transplant (DBD recipient, 56.3%; DCD recipient, 8.5%; ischemic cholangiopathy patient, 2.4%; retransplant recipient, 7.9%). Predictive modeling indicated that QALYs gained at 5 years were significantly higher in DCD recipients (3.77; 95% confidence interval [CI], 3.44-4.10) compared with those who remained on the waiting list for a DBD transplant with Model for End-Stage Liver Disease (MELD) scores of 15-20 (3.36; 95% CI, 3.28-3.43), or >20 (3.07; 95% CI, 3.00-3.14). There was no significant advantage for individuals with MELD scores <15 (3.55; 95% CI, 3.47-3.63). In conclusion, this model predicts that patients on the UK liver transplant waiting list with MELD scores >15 should receive an offered DCD allograft based on the QALYs gained at 5 years. This analysis only accounts for donor-recipient risk pairings seen in current practice. The optimal decision for patients with MELD scores <15 remains unclear. However, a survival benefit was observed when a DCD organ was accepted. Liver Transplantation 23 594-603 2017 AASLD.

Discontinuation and non-publication of surgical randomised controlled trials: observational study.

OBJECTIVE: To determine the rate of early discontinuation and non-publication of randomised controlled trials involving patients undergoing surgery. DESIGN: Cross sectional observational study of registered and published trials. SETTING: Randomised controlled trials of interventions in patients undergoing a surgical procedure. DATA SOURCES: The ClinicalTrials.gov database was searched for interventional trials registered between January 2008 and December 2009 using the keyword "surgery". Recruitment status was extracted from the ClinicalTrials.gov database. A systematic search for studies published in peer reviewed journals was performed; if they were not found, results posted on the ClinicalTrials.gov results database were sought. Email queries were sent to trial investigators of discontinued and unpublished completed trials if no reason for the respective status was disclosed. MAIN OUTCOME MEASURES: Trial discontinuation before completion and non-publication after completion. Logistic regression was used to determine the effect of funding source on publication status, with adjustment for intervention type and trial size. RESULTS: Of 818 registered trials found using the keyword "surgery", 395 met the inclusion criteria. Of these, 21% (81/395) were discontinued early, most commonly owing to poor recruitment (44%, 36/81). The remaining 314 (79%) trials proceeded to completion, with a publication rate of 66% (208/314) at a median time of 4.9 (interquartile range 4.0-6.0) years from study completion to publication search. A further 6% (20/314) of studies presented results on ClinicalTrials.gov without a corresponding peer reviewed publication. Industry funding did not affect the rate of discontinuation (adjusted odds ratio 0.91, 95% confidence interval 0.54 to 1.55) but was associated with a lower odds of publication for completed trials (0.43, 0.26 to 0.72). Investigators' email addresses for trials with an uncertain fate were identified for 71.4% (10/14) of discontinued trials and 83% (101/122) of unpublished studies. Only 43% (6/14) and 20% (25/122) replies were received. Email responses for completed trials indicated 11 trials in press, five published studies (four in non-indexed peer reviewed journals), and nine trials remaining unpublished. CONCLUSIONS: One in five surgical randomised controlled trials are discontinued early, one in three completed trials remain unpublished, and investigators of unpublished studies are frequently not contactable. This represents a waste of research resources and raises ethical concerns regarding hidden clinical data and futile participation by patients with its attendant risks. To promote future efficiency and transparency, changes are proposed to research governance frameworks to overcome these concerns.