Real-time monitoring and feedback to improve shared decision-making for surgery (the ALPACA Study): protocol for a mixed-methods study to inform co-development of an inclusive intervention

Introduction High-quality shared decision-making (SDM) is a priority of health services, but only achieved in a minority of surgical consultations. Improving SDM for surgical patients may lead to more effective care and moderate the impact of treatment consequences. There is a need to establish effective ways to achieve sustained and large-scale improvements in SDM for all patients whatever their background. The ALPACA Study aims to develop, pilot and evaluate a decision support intervention that uses real-time feedback of patients’ experience of SDM to change patients’ and healthcare professionals’ decision-making processes before adult elective surgery and to improve patient and health service outcomes.Methods and analysis This protocol outlines a mixed-methods study, involving diverse stakeholders (adult patients, healthcare professionals, members of the community) and three National Health Service (NHS) trusts in England. Detailed methods for the assessment of the feasibility, usability and stakeholder views of implementing a novel system to monitor the SDM process for surgery automatically and in real time are described. The study will measure the SDM process using validated instruments (CollaboRATE, SDM-Q-9, SHARED-Q10) and will conduct semi-structured interviews and focus groups to examine (1) the feasibility of automated data collection, (2) the usability of the novel system and (3) the views of diverse stakeholders to inform the use of the system to improve SDM. Future phases of this work will complete the development and evaluation of the intervention.Ethics and dissemination Ethical approval was granted by the NHS Health Research Authority North West-Liverpool Central Research Ethics Committee (reference: 21/PR/0345). Approval was also granted by North Bristol NHS Trust to undertake quality improvement work (reference: Q80008) overseen by the Consent and SDM Programme Board and reporting to an Executive Assurance Committee.Trial registration number ISRCTN17951423; Pre-results

Income deprivation and groin wound surgical site infection: cross-sectional analysis from the groin wound infection after vascular exposure multicenter cohort study

Background: Living in deprived areas is associated with poorer outcomes after certain vascular procedures and surgical site infection in other specialties. Our primary objective was to determine whether living in more income-deprived areas was associated with groin wound surgical site infection after arterial intervention. Secondary objectives were to determine whether living in more income-deprived areas was associated with mortality and clinical consequences of surgical site infection. Methods: Postal code data for patients from the United Kingdom who were included in the Groin Wound Infection after Vascular Exposure (GIVE) multicenter cohort study was used to determine income deprivation, based on index of multiple deprivation (IMD) data. Patients were divided into three IMD groups for descriptive analysis. Income deprivation score was integrated into the final multivariable model for predicting surgical site infection. Results: Only patients from England had sufficient postal code data, analysis included 772 groin incisions (624 patients from 22 centers). Surgical site infection occurred in 9.7% incisions (10.3% of patients). Surgical site infection was equivalent between income deprivation tertiles (tertile 1 = 9.5%; tertile 2 = 10.3%; tertile 3 = 8.6%; p = 0.828) as were the clinical consequences of surgical site infection and mortality. Income deprivation was not associated with surgical site infection in multivariable regression analysis (odds ratio [OR], 0.574; 95% confidence interval [CI], 0.038–8.747; p = 0.689). Median age at time of procedure was lower for patients living in more income-deprived areas (tertile 1 = 68 years; tertile 2 = 72 years; tertile 3 = 74 years; p < 0.001). Conclusions: We found no association between living in an income-deprived area and groin wound surgical site infection, clinical consequences of surgical site infection and mortality after arterial intervention. Patients living in more income-deprived areas presented for operative intervention at a younger age, with similar rates of comorbidities to patients living in less income-deprived areas. Groin wound surgical site infection (SSI) after arterial surgery is common [1], and research into reducing SSIs in vascular surgery is recognized as a priority by both clinicians and patient/caregiver representatives [2]. Despite the substantial potential morbidity and mortality of these SSIs [3,4], the available evidence relating to contributory factors is largely historic or reliant on retrospective data [5–7]. Further research on the epidemiology of SSI in this patient group is needed to allow better risk stratification, improve pre-operative discussions of risk with patients, and to guide targeted SSI prevention strategies that often include expensive prophylactic interventions [8]. However, little is currently known about the impact of socioeconomic characteristics on groin wound SSIs in this population. Socioeconomic deprivation is linked to health [9], and lifestyle-influenced cardiovascular diseases are more prevalent in more deprived areas [10]. Higher rates of unhealthy lifestyles (smoking, poor diet, and lack of physical exercise) in deprived areas are postulated to cause higher rates of cardiovascular risk increasing comorbidities, such as obesity and hyperlipidemia [10–12]. Several cardiovascular risk factors (e.g., smoking, body mass index, and diabetes mellitus), and peripheral arterial disease itself, are well recognized risk factors for SSI [13–16]. The association between socioeconomic deprivation and SSIs has previously been demonstrated in orthopedic surgery, cardiac surgery, and general surgery [17–19]. It is currently unknown whether living in an income-deprived area is associated with groin wound SSIs after arterial intervention. It was recently demonstrated in a large registry study in the United Kingdom, that outcomes following endovascular intervention for occlusive peripheral arterial disease were worse for patients living in deprived areas [20]. To the best of our knowledge, this aspect of outcomes after arterial intervention through a groin incision has not been investigated. Furthermore, studies demonstrating higher prevalence of cardiovascular disease risk factors in more deprived areas are now mostly historic and have not specifically investigated those presenting for arterial intervention through a groin incision for demographic differences in relation to deprivation [9–12]. Updated, prospective evidence is required to determine whether health inequalities persist for such patients today. Our primary objective was to determine whether residing in a more income-deprived area was associated with a higher risk of groin wound SSI after arterial intervention, by analyzing a subset of patients enrolled in the Groin wound Infection after Vascular Exposure (GIVE) multicenter cohort study [1,21]. Secondary objectives were to determine whether living in more income-deprived areas was associated with 30-day mortality and the clinical sequelae of SSI, and whether patients living in more income-deprived areas differed in terms of demographics and comorbidities compared with patients from less income-deprived areas