Patients awaiting surgery for neurosurgical diseases during the first wave of the COVID-19 pandemic in Spain: a multicentre cohort study.

OBJECTIVES: The large number of infected patients requiring mechanical ventilation has led to the postponement of scheduled neurosurgical procedures during the first wave of the COVID-19 pandemic. The aims of this study were to investigate the factors that influence the decision to postpone scheduled neurosurgical procedures and to evaluate the effect of the restriction in scheduled surgery adopted to deal with the first outbreak of the COVID-19 pandemic in Spain on the outcome of patients awaiting surgery. DESIGN: This was an observational retrospective study. SETTINGS: A tertiary-level multicentre study of neurosurgery activity between 1 March and 30 June 2020. PARTICIPANTS: A total of 680 patients awaiting any scheduled neurosurgical procedure were enrolled. 470 patients (69.1%) were awaiting surgery because of spine degenerative disease, 86 patients (12.6%) due to functional disorders, 58 patients (8.5%) due to brain or spine tumours, 25 patients (3.7%) due to cerebrospinal fluid (CSF) disorders and 17 patients (2.5%) due to cerebrovascular disease. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was mortality due to any reason and any deterioration of the specific neurosurgical condition. Second, we analysed the rate of confirmed SARS-CoV-2 infection. RESULTS: More than one-quarter of patients experienced clinical or radiological deterioration. The rate of worsening was higher among patients with functional (39.5%) or CSF disorders (40%). Two patients died (0.4%) during the waiting period, both because of a concurrent disease. We performed a multivariate logistic regression analysis to determine independent covariates associated with maintaining the surgical indication. We found that community SARS-CoV-2 incidence (OR=1.011, p<0.001), degenerative spine (OR=0.296, p=0.027) and expedited indications (OR=6.095, p<0.001) were independent factors for being operated on during the pandemic. CONCLUSIONS: Patients awaiting neurosurgery experienced significant collateral damage even when they were considered for scheduled procedures.

Factors associated with cancer treatment delay: a protocol for a systematic review and meta-analysis.

INTRODUCTION: Treatment delays are significantly associated with increased mortality risk among adult cancer patients; however, factors associated with these delays have not been robustly evaluated. This review and meta-analysis will evaluate factors associated with treatment delays among patients with five common cancers. METHODS AND ANALYSIS: Scientific databases including Ovid MEDLINE, Elsevier Embase, EBSCOhost CINAHL Plus Full Text, Elsevier Scopus and ProQuest Dissertations and Theses Global will be searched to identify relevant articles published between January 2000 and October 2021. Research articles published in the USA evaluating factors associated with treatment delay among breast, lung, prostate, cervical or colorectal adult cancer patients will be included. The primary outcome of the meta-analysis will be the pooled adjusted and unadjusted odds of treatment delay for patient, disease, provider and system-level factors defined according to specified time intervals. The secondary outcomes will be mean or median treatment delay for each cancer site according to first treatment and the influence of factors on the pooled mean treatment delay for each cancer site (via meta-regression analyses). Results from qualitative and mixed-methods studies will be narratively synthesised. Three reviewers will independently screen records generated from the search and two reviewers will independently extract data following a consensus agreement. Statistical heterogeneity will be assessed with a standard I2 test and funnel plots will be conducted to evaluate publication bias. Risk of bias will be assessed independently by two authors using validated tools according to the article's study design. ETHICS AND DISSEMINATION: Formal ethical approval is not required because the work is being carried out on publicly accessible studies. The findings of this review will be disseminated through a peer-reviewed scientific journal, academic conferences, social media, and key stakeholders. PROSPERO REGISTRATION NUMBER: CRD42021293131.

Outcome in patients undergoing postponed elective surgery during the COVID-19 pandemic (TRACE II): study protocol for a multicentre prospective observational study.

INTRODUCTION: During the COVID-19 pandemic many non-acute elective surgeries were cancelled or postponed around the world. This has created an opportunity to study the effect of delayed surgery on health conditions prior to surgery and postsurgical outcomes in patients with postponed elective surgery. The control group of the Routine Postsurgical Anesthesia Visit to Improve Patient Outcome (TRACE I) study, conducted between 2016 and 2019, will serve as a control cohort. METHODS AND ANALYSIS: TRACE II is an observational, multicentre, prospective cohort study among surgical patients with postponed surgery due to COVID-19 in academic and non-academic hospitals in the Netherlands. We aim to include 2500 adult patients. The primary outcome will be the 30-day incidence of major postoperative complications. Secondary outcome measures include the 30-day incidence of minor postoperative complications, 1 year mortality, length of stay (in hospital, medium care and intensive care), quality of recovery 30 days after surgery and postoperative quality of life up to 1 year following surgery. Multivariable logistic mixed-effects regression analysis with a random intercept for hospital will be used to test group differences on the primary outcome. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Institutional Review Board of Maastricht University Medical Centre+ and Amsterdam UMC. Findings will be presented at national and international conferences, as well as published in peer-reviewed scientific journals, with a preference for open access journals. Data will be made publicly available after publication of the main results. TRIAL REGISTRATION NUMBER: NL8841.

Cohort profile: The Bariatric Experience Long Term (BELONG): a long-term prospective study to understand the psychosocial, environmental, health and behavioural predictors of weight loss and regain in patients who have bariatric surgery

PurposeThe Bariatric Experience Long Term (BELONG) prospective study cohort was created to address limitations in the literature regarding the relationship between surgical weight loss and psychosocial, health, behaviour and environmental factors. The BELONG cohort is unique because it contains 70% gastric sleeve and 64% patients with non-white race/ethnicity and was developed with strong stakeholder engagement including patients and providers.ParticipantsThe BELONG cohort study included 1975 patients preparing to have bariatric surgery who completed a baseline survey in a large integrated health system in Southern California. Patients were primarily women (84%), either black or Hispanic (59%), with a body mass index (BMI) of 45.1±7.4 kg/m2, age 43.3±11.5 years old, and 32% had at least one comorbidity.Findings to dateA total of 5552 patients were approached before surgery between February 2016 and May 2017, and 1975 (42%) completed a baseline survey. A total of 1203 (73%) patients completed the year 1 and 1033 (74%) patients completed the year 3 postoperative survey. Of these survey respondents, 1341 at baseline, 999 at year 1, and 951 at year 3 were included in the analyses of all survey and weight outcome data. A total of 803 (60% of eligible patients) had survey data for all time points. Data collected were self-reported constructs to support the proposed theoretical model. Height, weight and BMI were ed from the electronic medical record to obtain the main outcomes of the study: weight loss and regain.Future plansWe will collect self-reported constructs and obtain height, weight and BMI from the electronic medical record 5 years after bariatric surgery between April 2022 and January 2023. We will also collect patient experiences using focus groups of 8–12 patients each throughout 2022.

Protocol for a scoping review on transition-related surgery procedures, outcome measures and access to care.

INTRODUCTION: Transgender and gender diverse (TGD) individuals often identify with a gender different to the one assigned at birth. Transition is a term used to describe the process TGD individuals take to live as their true gender. Surgery can be a very important aspect of care for members of TGD communities. Transition-related surgery (TRS) refers to many different types of surgeries completed to meet a TGD individual's gender-related goals. While various systematic reviews have attempted to synthesise the existing peer-reviewed literature around aspects of TRS, there are few scoping reviews in this area. Our scoping review aims to address this gap through providing an up-to-date overview of the TRS literature in order to provide an overarching view of the topic. METHOD AND ANALYSIS: This review will follow the methods outlined by the Joanna Briggs Institute's methodology for scoping reviews and will be reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. A search of nine scientific databases resulted in 20 062 potential articles. After removing duplicates, articles will be screened for inclusion using Covidence. Data extraction and synthesis will be carried out using NVivo and reviewed by team members. ETHICS AND DISSEMINATION: As this study is a scoping review of the existing literature, no ethics review is required. The findings from this review will be disseminated through multiple pathways including open access publication, submission to conferences, social media and Listservs. The findings of the study will also be readily available to clinicians, organizations, interest groups, and policy-makers.

Impact of the first wave of the SARS-CoV-2 pandemic on the outcome of neurosurgical patients: a nationwide study in Spain.

OBJECTIVE: To assess the effect of the first wave of the SARS-CoV-2 pandemic on the outcome of neurosurgical patients in Spain. SETTINGS: The initial flood of COVID-19 patients overwhelmed an unprepared healthcare system. Different measures were taken to deal with this overburden. The effect of these measures on neurosurgical patients, as well as the effect of COVID-19 itself, has not been thoroughly studied. PARTICIPANTS: This was a multicentre, nationwide, observational retrospective study of patients who underwent any neurosurgical operation from March to July 2020. INTERVENTIONS: An exploratory factorial analysis was performed to select the most relevant variables of the sample. PRIMARY AND SECONDARY OUTCOME MEASURES: Univariate and multivariate analyses were performed to identify independent predictors of mortality and postoperative SARS-CoV-2 infection. RESULTS: Sixteen hospitals registered 1677 operated patients. The overall mortality was 6.4%, and 2.9% (44 patients) suffered a perioperative SARS-CoV-2 infection. Of those infections, 24 were diagnosed postoperatively. Age (OR 1.05), perioperative SARS-CoV-2 infection (OR 4.7), community COVID-19 incidence (cases/105 people/week) (OR 1.006), postoperative neurological worsening (OR 5.9), postoperative need for airway support (OR 5.38), ASA grade ≥3 (OR 2.5) and preoperative GCS 3-8 (OR 2.82) were independently associated with mortality. For SARS-CoV-2 postoperative infection, screening swab test <72 hours preoperatively (OR 0.76), community COVID-19 incidence (cases/105 people/week) (OR 1.011), preoperative cognitive impairment (OR 2.784), postoperative sepsis (OR 3.807) and an absence of postoperative complications (OR 0.188) were independently associated. CONCLUSIONS: Perioperative SARS-CoV-2 infection in neurosurgical patients was associated with an increase in mortality by almost fivefold. Community COVID-19 incidence (cases/105 people/week) was a statistically independent predictor of mortality. TRIAL REGISTRATION NUMBER: CEIM 20/217.

Behaviours of older adults and caregivers preparing for elective surgery: a virtually conducted mixed-methods research protocol to improve surgical outcomes.

INTRODUCTION: Older adults (age ≥65 years) are pursuing increasingly complex, elective surgeries; and, are at higher risk for intraoperative and postoperative complications. Patients and their caregivers frequently struggle with the postoperative recovery process at home, which may contribute to complications. We aim to identify opportunities to intervene during the preoperative period to improve postoperative outcomes by understanding the preparatory behaviours of older adults and their caregivers before a complex, elective surgery. METHODS AND ANALYSIS: As a result of the COVID-19 pandemic, we will conduct this study via telephone and videoconferencing. Using a multiphase mixed-methods research design, we will collect data on 10-15 patient-caregiver dyads from a pool of older adults (across a spectrum of cognitive abilities) scheduled for an elective colorectal surgery between 1 July 2020 and 30 May 2021. We will collect quantitative and qualitative data before (T1, T2) and after (T3, T4) surgery. Preoperatively, participants will each complete a cognitive assessment and a semi-structured qualitative interview that focuses on their preparatory behaviours (T1). They will then answer questionnaires about mood, self-efficacy and home environment (T2). Three weeks following hospital discharge, participants will complete another qualitative interview focusing on a comparison of preoperative and postoperative preparedness (T3). Researchers will also collect information about the patient's medical conditions, the postoperative complications and healthcare utilisation from the patient's chart 30 days following discharge (T4). We will code and conduct thematic analysis of the qualitative data to identify salient themes. Quantitative data will be analysed using basic descriptive statistics to characterise the participants. We will integrate the qualitative and quantitative findings using results from the quantitative scales to group participants and with use of joint display analysis. ETHICS AND DISSEMINATION: Ethics approval was obtained from the University of Michigan IRB. Study findings will be disseminated through peer-reviewed journals and presentations at conferences.

Are we advancing universal health coverage through cataract services? Protocol for a scoping review.

INTRODUCTION: Universal health coverage (UHC) includes the dimensions of equity in access, quality services that improve health and protection against financial hardship. Cataract continues to be the leading cause of blindness globally, despite cataract surgery being an efficacious intervention. The aim of this scoping review is to map the nature, extent and global distribution of data on cataract services for UHC in terms of equity, access, quality and financial protection. METHODS AND ANALYSIS: The search will be constructed by an Information Specialist and undertaken in MEDLINE, Embase and Global Health databases. We will include all published non-interventional primary research studies and systematic reviews that report a quantitative assessment of access, equity, quality or financial protection of cataract surgical services for adults at the subnational, national, regional or global level from population-based surveys or routinely collected health service data since 1 January 2000 and published through to February 2020.Screening and data charting will be undertaken using Covidence systematic review software. Titles and abstracts of identified studies will be screened by two authors independently. Full-text articles of potentially relevant studies will be obtained and reviewed independently by two authors against the inclusion criteria. Any discrepancies between the authors will be resolved by discussion, and with a third author as necessary. A data charting form will be developed and piloted on three studies by three authors and amendments made as necessary. Data will be extracted by two reviewers independently and summarised narratively and using maps. ETHICS AND DISSEMINATION: Ethical approval was not sought as the scoping review will only use published and publicly accessible data. The review will be published in an open access peer-reviewed journal. A summary of the results will be developed for website posting, stakeholder meetings and inclusion in the ongoing Lancet Global Health Commission on Global Eye Health.

Midline incisional hernia prophylaxis using synthetic mesh in an emergency or urgent gastrointestinal tract surgery: a protocol for multicentre randomised clinical trial.

INTRODUCTION: Between 5% and 30% of abdominal incisions eventually result in incisional hernias (IHs) that can lead to severe complications and impaired quality of life. Unfortunately, IH repair is often unsuccessful; therefore, hernia prophylaxis is an important issue. The efficacy of mesh augmentation has been proven for hernia prophylaxis in high-risk patients, but no randomised clinical trial has evaluated prophylactic mesh placement in emergency/urgent gastrointestinal operations. METHODS AND ANALYSIS: A multicentre, prospective randomised, open and patient-assessor blinded endpoint design will be conducted. A total of 470 patients will be enrolled and randomly allocated to retrorectus mesh augmentation with lightweight polypropylene mesh or primary suture closure. The primary outcome is IH occurrence within 24 months of follow-up, while other clinical outcomes are secondary endpoints. A cost-effectiveness analysis will be conducted from the societal and provider perspectives. ETHICS AND DISSEMINATION: Ethics approval was obtained from Ramathibodi Hospital (MURA2020/1478) and Vajira Hospital (COA164/2563). The protocol is on the process of submission to the local ethics committee of the other study sites. Results will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: TCTR20200924002.

Study protocol for a prospective, double-blinded, observational study investigating the diagnostic accuracy of an app-based diagnostic health care application in an emergency room setting: the eRadaR trial.

INTRODUCTION: Occurrence of inaccurate or delayed diagnoses is a significant concern in patient care, particularly in emergency medicine, where decision making is often constrained by high throughput and inaccurate admission diagnoses. Artificial intelligence-based diagnostic decision support system have been developed to enhance clinical performance by suggesting differential diagnoses to a given case, based on an integrated medical knowledge base and machine learning techniques. The purpose of the study is to evaluate the diagnostic accuracy of Ada, an app-based diagnostic tool and the impact on patient outcome. METHODS AND ANALYSIS: The eRadaR trial is a prospective, double-blinded study with patients presenting to the emergency room (ER) with abdominal pain. At initial contact in the ER, a structured interview will be performed using the Ada-App and both, patients and attending physicians, will be blinded to the proposed diagnosis lists until trial completion. Throughout the study, clinical data relating to diagnostic findings and types of therapy will be obtained and the follow-up until day 90 will comprise occurrence of complications and overall survival of patients. The primary efficacy of the trial is defined by the percentage of correct diagnoses suggested by Ada compared with the final discharge diagnosis. Further, accuracy and timing of diagnosis will be compared with decision making of classical doctor-patient interaction. Secondary objectives are complications, length of hospital stay and overall survival. ETHICS AND DISSEMINATION: Ethical approval was received by the independent ethics committee (IEC) of the Goethe-University Frankfurt on 9 April 2020 including the patient information material and informed consent form. All protocol amendments must be reported to and adapted by the IEC. The results from this study will be submitted to peer-reviewed journals and reported at suitable national and international meetings. TRIAL REGISTRATION NUMBER: DRKS00019098.