Evaluating patient factors, operative management and postoperative outcomes in trauma laparotomy patients worldwide: a protocol for a global observational multicentre trauma study.

INTRODUCTION: Trauma contributes to the greatest loss of disability-adjusted life-years for adolescents and young adults worldwide. In the context of global abdominal trauma, the trauma laparotomy is the most commonly performed operation. Variation likely exists in how these patients are managed and their subsequent outcomes, yet very little global data on the topic currently exists. The objective of the GOAL-Trauma study is to evaluate both patient and injury factors for those undergoing trauma laparotomy, their clinical management and postoperative outcomes. METHODS: We describe a planned prospective multicentre observational cohort study of patients undergoing trauma laparotomy. We will include patients of all ages who present to hospital with a blunt or penetrating injury and undergo a trauma laparotomy within 5 days of presentation to the treating centre. The study will collect system, patient, process and outcome data, following patients up until 30 days postoperatively (or until discharge or death, whichever is first). Our sample size calculation suggests we will need to recruit 552 patients from approximately 150 recruiting centres. DISCUSSION: The GOAL-Trauma study will provide a global snapshot of the current management and outcomes for patients undergoing a trauma laparotomy. It will also provide insight into the variation seen in the time delays for receiving care, the disease and patient factors present, and patient outcomes. For current standards of trauma care to be improved worldwide, a greater understanding of the current state of trauma laparotomy care is paramount if appropriate interventions and targets are to be identified and implemented.

Impact of Medicaid Expansion and Firearm Legislation on Cost of Firearm Injuries.

INTRODUCTION: Firearm injury-related hospitalizations in the U.S. cost $900 million annually. Before the Affordable Care Act, government insurance programs covered 41% of the costs. This study describes the impact of Affordable Care Act Medicaid expansion and state-level firearm legislation on coverage and costs for firearm injuries. METHODS: This cross-sectional study included 35,854,586 hospitalizations from 27 states in 2013 and 2016. Data analyses were performed in 2022. Firearm injuries were classified by mechanism: assault, unintentional, self-harm, or undetermined. The impact of the Affordable Care Act expansion was determined using difference-in-differences analysis. Differences in per capita costs between states with stronger and weak firearm legislation were compared using univariable and multivariable analyses. RESULTS: The authors identified 31,451 initial firearm injury-related hospitalizations. In states with weak firearm legislation, hospitalization costs per 100,000 residents were higher from unintentional ($25,834; p=0.04) and self-inflicted ($11,550; p=0.02) injuries; there were no state-level differences in assault or total per capita firearm-related hospitalization costs. Affordable Care Act expansion increased government coverage of costs by 15 percentage points (95% CI=3, 29) and decreased costs to uninsured/self-pay by 14 percentage points (95% CI=6, 21). In 2016, states with weak firearm legislation and no Affordable Care Act expansion had the highest proportion of hospitalization costs attributed to uninsured/self-pay patients (24%, 95% CI=15, 34). CONCLUSIONS: Affordable Care Act expansion increased government coverage of hospitalizations for firearm injuries. Unintentional and self-harm costs were significantly higher for states with weak firearm legislation. States with weak firearm legislation that did not expand Medicaid had the highest proportion of uninsured/self-pay patients.

Thoracic and Lumbar Spine Injury: Evidence-Based Diagnosis, Management, and Outcomes.

BACKGROUND: Traumatic thoracolumbar spine injuries are associated with significant morbidity and mortality. Targeted for non-spine specialist trauma surgeons, this systematic scoping review aimed to examine literature for up-to-date evidence on presentation, management, and outcomes of thoracolumbar spine injuries in adult trauma patients. METHODS: This review was reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist. We searched four bibliographic databases: PubMed, EMBASE, Web of Science, and the Cochrane Library. Eligible studies included experimental, observational, and evidence-synthesis articles evaluating patients with thoracic, lumbar, or thoracolumbar spine injury, published in English between January 1, 2010 and January 31, 2021. Studies which focused on animals, cadavers, cohorts with N <30, and pediatric cohorts (age <18 years old), as well as case studies, abstracts, and commentaries were excluded. RESULTS: A total of 2501 studies were screened, of which 326 unique studies were fully text reviewed and twelve aspects of injury management were identified and discussed: injury patterns, determination of injury status and imaging options, considerations in management, and patient quality of life. We found: (1) imaging is a necessary diagnostic tool, (2) no consensus exists for preferred injury characterization scoring systems, (3) operative management should be considered for unstable fractures, decompression, and deformity, and (4) certain patients experience significant burden following injury. DISCUSSION: In this systematic scoping review, we present the most up-to-date information regarding the management of traumatic thoracolumbar spine injuries. This allows non-specialist trauma surgeons to become more familiar with thoracolumbar spine injuries in trauma patients and provides a framework for their management.

Scalability and Sustainability of a Surgical Infection Prevention Program in Low-Income Environments.

Importance: Surgical infections are a major cause of perioperative morbidity and mortality, particularly in low-resource settings. Clean Cut, a 6-month quality improvement program developed by the global nonprofit organization Lifebox, has demonstrated improvements in postoperative infectious complications. However, the pilot program required intense external programmatic and resource support. Objective: To examine the improvement in adherence to infection prevention and control standards and rates of postoperative infections in hospitals in the Clean Cut program after implementation strategies were updated and program execution was refined. Design, Setting, and Participants: This cohort study evaluated and refined the Clean Cut implementation strategy to enhance scalability based on a qualitative study of its pilot phase, including formalizing programmatic and educational materials, building an automated data entry and analysis platform, and reorganizing hospital-based team composition. Clean Cut was introduced from January 1, 2019, to February 28, 2022, in 7 Ethiopian hospitals that had not previously participated in the program. Prospective data initiated on arrival in the operating room were collected, and patients were followed up through hospital discharge and with 30-day follow-up telephone calls. Exposure: Implementation of the refined Clean Cut program. Main Outcomes and Measures: The primary outcome was surgical site infection (SSI); secondary outcomes were adherence to 6 infection prevention standards, mortality, hospital length of stay, and other infectious complications. Results: A total of 3364 patients (mean [SD] age, 26.5 [38.0] years; 2196 [65.3%] female) from 7 Ethiopian hospitals were studied (1575 at baseline and 1789 after intervention). After controlling for confounders, the relative risk of SSIs was reduced by 34.0% after program implementation (relative risk, 0.66; 95% CI, 0.54-0.81; P < .001). Appropriate Surgical Safety Checklist use increased from 16.3% to 43.0% (P < .001), surgeon hand and patient skin antisepsis improved from 46.0% to 66.0% (P < .001), and timely antibiotic administration improved from 17.8% to 39.0% (P < .001). Surgical instrument (38.7% vs 10.2%), linen sterility (35.5% vs 12.8%), and gauze counting (89.2% vs 82.5%; P < .001 for all comparisons) also improved significantly. Conclusions and Relevance: A modified implementation strategy for the Clean Cut program focusing on reduced external resource and programmatic input from Lifebox, structured education and training materials, and wider hospital engagement resulted in outcomes that matched our pilot study, with improved adherence to recognized infection prevention standards resulting in a reduction in SSIs. The demonstration of scalability reinforces the value of this SSI prevention program.

Correlation of effectiveness and tolerability assessments from a pharmacy-based observational study investigating the fixed-dose combination of 400 mg ibuprofen plus 100 mg caffeine for the treatment of acute headache.

Introduction: Observational studies are valuable for investigating correlations between patient-reported treatment outcomes. In this study, we report a secondary analysis of a published pharmacy-based observational (patient-centered "real-world" outcomes) study on experiences reported by patients who treated their headache with an over-the-counter analgesic. Methods: A pharmacy-based exploratory survey was conducted in German community pharmacies. Patients buying a fixed-dose analgesic combination product (400 mg ibuprofen + 100 mg caffeine; IbuCaff) to treat their headache were offered a questionnaire that contained-among others-questions about time to onset of pain relief (OPR), assessment of time to onset of pain relief (AOPR), assessment of efficacy and tolerability, and pain intensity 2 h after intake. A correlation analysis of the data was performed. Moreover, perceived treatment effects compared to other acute headache medications used in the past were collected. Results: The correlation between OPR and AOPR was high (Spearman rank correlation r = 0.594, p < 0.0001). Headache patients assessed the onset of analgesic action within 15 min as "very fast" and within 30 min as "fast". The other readouts were correlated as well [assessment of efficacy and % pain intensity difference (%PID) at 2 h: r = 0.487; OPR/AOPR and %PID at 2 h: r = 0.295/0.318; OPR/AOPR and assessment of tolerability: r = 0.206/0.397; OPR/AOPR and assessment of efficacy: r = 0.406/0.594; assessment of efficacy and assessment of tolerability: r = 0.608; p < 0.0001 for all correlations]. Compared to previous treatments, most patients (>89%) assessed the speed of analgesic action, efficacy, and tolerability of IbuCaff as equal to or better than for the previous treatment. Discussion: Headache patients assessed the onset of analgesia within 15 min as "very fast" and within 30 min as "fast". Efficacy assessments for acute headache medication appear to be highly correlated.

Perioperative optimisation in low- and middle-income countries (LMICs): A systematic review and meta-analysis of enhanced recovery after surgery (ERAS).

Background: Enhanced recovery after surgery (ERAS) protocols have largely been incorporated into practice in high-income settings due to proven improvement in perioperative outcomes. We aimed to review the implementation of ERAS protocols and other perioperative optimisation strategies in low- and middle-income countries (LMICs) and their impact on length of hospital stay (LOS). Methods: We searched MEDLINE, PubMed, Global Health (CABI), WHO Global Index Medicus, Index Medicus, and Latin American and Caribbean Health Sciences Literature (LILACS) for studies incorporating ERAS or other prehabilitation approaches in LMICs. We conducted a pooled analysis of LOS using a random-effects model to evaluate the impact of such programs. This systematic review was pre-registered on PROSPERO. Results: We screened 1205 studies and included 70 for a full-text review; six were eligible for inclusion and five for quantitative analysis, two of which were randomised controlled trials. ERAS was compared to routine practice in all included studies, while none implemented prehabilitation or other preoperative optimisation strategies. Pooled analysis of 290 patients showed reduced LOS in the ERAS group with a standardised mean difference of -2.18 (95% confidence interval (CI) = -4.13, -.0.05, P < 0.01). The prediction interval was wide (95% CI = -7.85, 3.48) with substantial heterogeneity (I2 = 94%). Conclusions: Perioperative optimisation is feasible in LMICs and appears to reduce LOS, despite high levels of between-study heterogeneity. There is a need for high-quality data on perioperative practice in LMICs and supplementary qualitative analysis to further understand barriers to perioperative optimisation implementation. Registration: PROSPERO: CRD42021279053.

Pulse oximetry training landscape for healthcare workers in low- and middle-income countries: A scoping review.

Background: Pulse oximetry has been used in medical care for decades. Its use quickly became standard of care in high resource settings, with delayed widespread availability and use in lower resource settings. Pulse oximetry training initiatives have been ongoing for years, but a map of the literature describing such initiatives among health care workers in low- and middle-income countries (LMICs) has not previously been conducted. Additionally, the coronavirus disease 2019 (COVID-19) pandemic further highlighted the inequitable distribution of pulse oximetry use and training. We aimed to characterise the landscape of pulse oximetry training for health care workers in LMICs prior to the COVID-19 pandemic as described in the literature. Methods: We systematically searched six databases to identify studies reporting pulse oximetry training among health care workers, broadly defined, in LMICs prior to the COVID-19 pandemic. Two reviewers independently assessed titles and abstracts and relevant full texts for eligibility. Data were charted by one author and reviewed for accuracy by a second. We synthesised the results using a narrative synthesis. Results: A total of 7423 studies were identified and 182 screened in full. A total of 55 training initiatives in 42 countries met inclusion criteria, as described in 66 studies since some included studies reported on different aspects of the same training initiative. Five overarching reasons for conducting pulse oximetry training were identified: 1) anaesthesia and perioperative care, 2) respiratory support programme expansion, 3) perinatal assessment and monitoring, 4) assessment and monitoring of children and 5) assessment and monitoring of adults. Educational programmes varied in their purpose with respect to the types of patients being targeted, the health care workers being instructed, and the depth of pulse oximetry specific training. Conclusions: Pulse oximetry training initiatives have been ongoing for decades for a variety of purposes, utilising a multitude of approaches to equip health care workers with tools to improve patient care. It is important that these initiatives continue as pulse oximetry availability and knowledge gaps remain. Neither pulse oximetry provision nor training alone is enough to bolster patient care, but sustainable solutions for both must be considered to meet the needs of both health care workers and patients.

Addressing knowledge gaps in Surgical Safety Checklist use: statistical process control analysis of a surgical quality improvement programme in Ethiopia.

BACKGROUND: The WHO Surgical Safety Checklist reduces morbidity and mortality after surgery, but uptake remains challenging. In particular, low-income countries have been found to have lower rates of checklist use compared with high-income countries. The aim of this study was to determine the impact of educational workshops on Surgical Safety Checklist use implemented as part of a quality improvement initiative in five hospitals in Ethiopia that had variable experience with the Surgical Safety Checklist. METHODS: From April 2019 to September 2020, each hospital implemented a 6-month surgical quality improvement programme, which included a Surgical Safety Checklist workshop. Statistical process control methodology was used to understand the variation in Surgical Safety Checklist compliance before and after workshops and a time-series analysis was performed using population-averaged generalized estimating equation Poisson regression. Checklist compliance was defined as correctly completing a sign in, timeout, and sign out. Incidence rate ratios of correct checklist use pre- and post-intervention were calculated and the change in mean weekly compliance was predicted. RESULTS: Checklist compliance data were obtained from 2767 operations (1940 (70 per cent) pre-intervention and 827 (30 per cent) post-intervention). Mean weekly checklist compliance improved from 27.3 to 41.2 per cent (mean difference 13.9 per cent, P = 0.001; incidence rate ratio 1.51, P = 0.001). Hospitals with higher checklist compliance at baseline had the greatest overall improvements in compliance, more than 50 per cent over pre-intervention, while low-performing hospitals showed no improvement. CONCLUSION: Surgical Safety Checklist workshops improved checklist compliance in hospitals with some experience with its use. Workshops had little effect in hospitals unfamiliar with the Surgical Safety Checklist, emphasizing the importance of multifactorial interventions and culture-change approaches. In receptive facilities, short workshops can accelerate behaviour change.

Exploring the Use of a Fit-for-Purpose Surgical Headlight in Sub-Saharan Africa: Mixed Methods Study.

BACKGROUND: High-quality surgical lighting is often lacking in low-resource settings. Commercial surgical headlights are unavailable due to high cost and supply and maintenance challenges. We aimed to understand user needs of a surgical headlight for low-resource settings by evaluating a preselected robust but relatively inexpensive headlight and lighting conditions. METHODS: We observed headlight use by ten surgeons in Ethiopia and six in Liberia. All surgeons completed surveys about their lighting environment and experience using headlight, and were subsequently interviewed. Twelve surgeons completed logbooks on headlight use. We distributed headlights to 48 additional surgeons, and all surgeons were surveyed for feedback. RESULTS: In Ethiopia, five surgeons ranked operating room light quality as poor or very poor; seven delayed or cancelled operations within the last year and five described intraoperative complications due to poor lighting. In Liberia, lighting was rated as "good", however fieldnotes, and interviews noted generator fuel-rationing, and poor lighting conditions. In both countries, the headlight was considered extremely useful. Surgeons recommended nine improvements, including comfort, durability, affordability and availability of multiple rechargeable batteries. Thematic analysis identified factors influencing headlight use, specifications and feedback, and infrastructure challenges. CONCLUSION: Lighting in surveyed operating rooms was poor. Although conditions and need for the headlights differed between Ethiopia and Liberia, headlights were considered highly useful. However, discomfort was a major limiting factor for ongoing use, and the hardest to objectively characterise for specification and engineering purposes. Specific needs for surgical headlights include comfort and durability. Refinement of a fit-for-purpose surgical headlight is ongoing.

Multisystem Inflammatory Syndrome in American Indian/Alaska Native Children, March 2020-May 2022.

We describe characteristics, clinical features and outcomes of multisystem inflammatory syndrome in children among American Indian and Alaska Native (AI/AN) persons compared with non-Hispanic white persons. AI/AN patients with multisystem inflammatory syndrome in children were younger, more often obese, and from areas of higher social vulnerability. A greater proportion of AI/AN patients had severe respiratory involvement and shock.

Lack of Evidence for Blood Pressure Effects of Caffeine Added to Ibuprofen.

BACKGROUND: Caffeine enhances the efficacy of non-opioid analgesics. Data on the cardiovascular health effects of caffeine intake are controversial, and studies on the cardiovascular effects of medical caffeine use are lacking. OBJECTIVE: The study aims to explore the cardiovascular effects of an ibuprofen/caffeine combination in comparison to ibuprofen alone. METHODS: Secondary analysis of a previously reported bioequivalence study of a single dose of a fixed dose ibuprofen/caffeine combination (400/100 mg) vs. ibuprofen alone in a randomized, cross-over design in 36 healthy volunteers. Plasma catecholamines were analyzed to enhance mechanistic interpretation of the data. RESULTS: After exclusion of 10 protocol violators (pre-dosing intake of caffeine), vital signs were comparable over a 24-h period in the absence and presence of caffeine. Plasma catecholamine levels were also comparable. CONCLUSION: These data do not support the hypothesis that occasional intake of a small dose of caffeine as part of pain medication imposes a health risk due to vital sign changes. Based on the proven increase in efficacy, the addition of caffeine to non-opioid analgesics such as IBU has a favorable risk/benefit profile for occasional use.

[Analgesic use in Germany : Survey of the years 2008 to 2019]. / Schmerzmittelgebrauch in Deutschland : Eine Erhebung über die Jahre 2008 bis 2019.

BACKGROUND: There are previously published data on the per capita use of analgesics in Germany, but only to 2005. In the present analysis, data for the years 2008-2019 were evaluated. The use of prescription and nonprescription analgesics was investigated and possible influencing factors were discussed. MATERIALS AND METHODS: The per capita use of prescription and nonprescription analgesics was determined based on data on prescriptions and cash purchases in pharmacies (IMS Pharmascope®, Wiener Neudorf, Austria). Moreover, an evaluation according to active substances was performed for nonprescription drugs. In addition, pharmaceutical manufacturers' advertising expenditures and changes in distribution channels were analyzed as possible influencing factors. RESULTS: During the observation period 2008-2019, the use of prescription analgesics in Germany increased, while the use of nonprescription analgesics decreased. Single-agent drugs constitute the majority of sales of nonprescription analgesics. The share of combination drugs has decreased in recent years. CONCLUSION: The use of nonprescription analgesics in Germany decreased between 2008 and 2019. The trend as of 1995, which was observed in a previous investigation, is therefore continuing. External factors, such as the increase in advertising expenses or easier access via mail-order pharmacies, do not appear to influence use.

Adapting a Telehealth Network for Emergency COVID-19 Pandemic Response, 2020-2021.

In March 2020, a Tribal telehealth program-the Indian Country Extension for Community Health Outcomes (ECHO)-added emergency COVID-19 to its programming to support the pandemic response. A long-standing relationship with a network of Indian Health Service, Tribal, and urban Indian clinicians supported a rapid launch of the COVID-19 telehealth program. This nationwide service offered primary care clinicians and staff serving American Indian/Alaska Native people access to virtual learning opportunities, expert clinical recommendations, technical assistance, and capacity building. From March 12, 2020, through April 30, 2021, the program provided 85 clinical sessions in 12 months, with an average participation of 120 attendees per clinic (N = 11 710). Attendees could complete a voluntary evaluation form for each session via an online link. A total of 2595 forms were completed. Attendees came from 33 states and 206 unique locations, primarily from the Pacific Northwest (n = 931, 35.9%). Most pharmacists (78.1%), providers (ie, medical doctor, doctor of osteopathy, advanced practice nurse, physician assistant, or clinical nurse midwife; 70.8%), and nurses (59.6%) gave the sessions the highest rating of "very satisfied." The highest proportion of attendees indicating that they planned a change in practice were pharmacists (68.0%), nurses, (64.1%), and providers (61.3%). Most attendees (93.1%) said that the COVID-19 sessions gave them a sense of social support. Lessons learned were that (1) a telehealth platform can be quickly retasked for emergency response with no further delays, (2) a telehealth network can be scaled up quickly with participation from preexisting relationships, and (3) the platform is flexible and adaptable to the needs of participants. An existing telehealth program can be a key part of timely, relevant, large-scale emergency readiness and response efforts.

Bridging the know-do gap in low-income surgical environments: Creating contextually appropriate training videos to promote safer surgery in Ethiopia.

Although international guidelines exist for the prevention of surgical site infections, their implementation in diverse clinical contexts, especially in low and middle-income countries, is challenging due to the lack of available resources and organizational structure of facilities. The goal of this project was to develop a series of video training aids to highlight best practices in surgical infection prevention in hospitals with limited resources and to provide practical solutions to common challenges faced in these settings. Using the validated Clean Cut education framework for infection prevention developed by Lifebox, a charity devoted to improving surgical and anesthetic safety, we partnered with clinicians in one Ethiopian hospital to create six educational videos giving practical guidelines for infection prevention under resource variable conditions. These include: 1) proper use of the WHO Surgical Safety Checklist, 2) hand and skin antisepsis, 3) confirming instrument sterility, 4) maintaining the sterile field, 5) antibiotic prophylaxis, and 6) gauze counting. Gaps in available online educational materials were identified in each of the six areas. Videos were created providing setting-specific education and addressing gaps in existing materials for each of the infection prevention topics. These videos are now integrated into infection prevention curricula through Lifebox in Ethiopia and ongoing data collection to evaluate acceptability and efficacy is ongoing. Surgical education videos on infection prevention topics addressing location-specific resources and workarounds can be useful to hospitals operating in resource-limited settings for training staff and supporting quality and safety efforts in surgery.

Mapping population access to essential surgical care in Liberia using equipment, personnel, and bellwether capability standards.

BACKGROUND: Accurate surveillance of population access to essential surgery is key for strategic healthcare planning. This study aimed to estimate population access to surgical facilities meeting standards for safe surgery equipment, specialized surgical personnel, and bellwether capability, cesarean delivery, emergency laparotomy, and long-bone fracture fixation and to evaluate the validity of using these standards to describe the full breadth of essential surgical care needs in Liberia. METHOD: An observational study of surgical facilities was conducted in Liberia between 20 September and 8 November 2018. Facility data were combined with geospatial data and analysed in an online visualization platform. RESULTS: Data were collected from 51 of 52 surgical facilities. Nationally, 52.9 per cent of the population (2 392 000 of 4 525 000 people) had 2-h access to their closest surgical facility, whereas 41.1 per cent (1 858 000 people) and 48.6 per cent (2 199 000 people) had 2-h access to a facility meeting the personnel and equipment standards respectively. Six facilities performed all bellwether procedures; 38.7 per cent of the population (1 751 000 people) had 2-h access to one of these facilities. Bellwether-capable facilities were more likely to perform other essential surgical procedures (OR 3.13, 95 per cent c.i. 1.28 to 7.65; P = 0.012). These facilities delivered a median of 13.0 (i.q.r. 11.3-16.5) additional essential procedures. CONCLUSION: Population access to essential surgery is limited in Liberia; strategies to reduce travel times ought to be part of healthcare policy. Policymakers should also be aware that bellwether capability might not be a valid proxy for the full breadth of essential surgical care in low-income settings.

Outcomes of Early Versus Late Tracheostomy in Patients With COVID-19: A Multinational Cohort Study.

Timing of tracheostomy in patients with COVID-19 has attracted substantial attention. Initial guidelines recommended delaying or avoiding tracheostomy due to the potential for particle aerosolization and theoretical risk to providers. However, early tracheostomy could improve patient outcomes and alleviate resource shortages. This study compares outcomes in a diverse population of hospitalized COVID-19 patients who underwent tracheostomy either "early" (within 14 d of intubation) or "late" (more than 14 d after intubation). DESIGN: International multi-institute retrospective cohort study. SETTING: Thirteen hospitals in Bolivia, Brazil, Spain, and the United States. PATIENTS: Hospitalized patients with COVID-19 undergoing early or late tracheostomy between March 1, 2020, and March 31, 2021. INTERVENTIONS: Not applicable. MEASUREMENTS AND MAIN RESULTS: A total of 549 patients from 13 hospitals in four countries were included in the final analysis. Multivariable regression analysis showed that early tracheostomy was associated with a 12-day decrease in time on mechanical ventilation (95% CI, -16 to -8; p < 0.001). Further, ICU and hospital lengths of stay in patients undergoing early tracheostomy were 15 days (95% CI, -23 to -9 d; p < 0.001) and 22 days (95% CI, -31 to -12 d) shorter, respectively. In contrast, early tracheostomy patients experienced lower risk-adjusted survival at 30-day post-admission (hazard ratio, 3.0; 95% CI, 1.8-5.2). Differences in 90-day post-admission survival were not identified. CONCLUSIONS: COVID-19 patients undergoing tracheostomy within 14 days of intubation have reduced ventilator dependence as well as reduced lengths of stay. However, early tracheostomy patients experienced lower 30-day survival. Future efforts should identify patients most likely to benefit from early tracheostomy while accounting for location-specific capacity.

Pulse oximeter provision and training of non-physician anesthetists in Zambia: a qualitative study exploring perioperative care after training.

BACKGROUND: Pulse oximetry monitoring is included in the WHO Safe Surgery Checklist and recognized as an essential perioperative safety monitoring device. However, many low resource countries do not have adequate numbers of pulse oximeters available or healthcare workers trained in their use. Lifebox, a nonprofit organization focused on improving anesthetic and surgical safety, has procured and distributed pulse oximeters and relevant educational training in over 100 countries. We aimed to understand qualitatively how pulse oximetry provision and training affected a group of Zambian non-physician anesthetists' perioperative care and what, if any, capacity gaps remain. METHODS: We identified and approached non-physician anesthetists (NPAPs) in Zambia who attended a 2019 Lifebox pulse oximetry training course to participate in a semi-structured interview. Interviews were audio recorded and transcribed. Codes were iteratively derived; the codebook was tested for inter-rater reliability (pooled kappa > 0.70). Team-based thematic analysis identified emergent themes on pulse oximetry training and perioperative patient care. RESULTS: Ten of the 35 attendees were interviewed. Two themes emerged concerning pulse oximetry provision and training in discussion with non-physician anesthetists about their experience after training: (1) Impact on Non-Physician Anesthetists and the Healthcare Team and (2) Impact on Perioperative Patient Monitoring. These broad themes were further explored through subthemes. Increased knowledge brought confidence in monitoring and facilitated quick interventions. NPAPs reported improved preoperative assessments and reaffirmed the necessity of having pulse oximetry intraoperatively. However, lack of device availability led to case delays or cancellations. A portable device travelling with the patient to the recovery ward was noted as a major improvement in postoperative care. Pulse oximeters also improved communication between nurses and NPAPs, giving NPAPs confidence in the recovery process. However, this was not always possible, as lack of pulse oximeters and ward staff unfamiliarity with oximetry was commonly reported. NPAPs expressed that wider pulse oximetry availability and training would be beneficial. CONCLUSION: Among a cohort of non-physician anesthetists in Zambia, the provision of pulse oximeters and training was perceived to improve patient care throughout the perioperative timeline. However, capacity and resource gaps remain in their practice settings, especially during transfers of care. NPAPs identified a number of areas where patient care and safety could be improved, including expanding access to pulse oximetry training and provision to ward and nursing staff to ensure the entire healthcare team is aware of the benefits and importance of its use.

Evaluation of an adaptive, multimodal intervention to reduce postoperative infections following cesarean delivery in Ethiopia: study protocol of the CLEAN-CS cluster-randomized stepped wedge interventional trial.

BACKGROUND: We previously developed and pilot tested Clean Cut, a program to prevent postoperative infections by improving compliance with the WHO Surgical Safety Checklist (SSC) and strengthening adherence to infection control practices. This protocol describes the CheckList Expansion for Antisepsis and iNfection Control in Cesarean Section (CLEAN-CS) trial evaluating our program's ability to reduce infections following CS and other obstetric and gynecological operations in Ethiopia. METHODS/DESIGN: CLEAN-CS is a cluster-randomized stepped wedge interventional trial with five clusters (two hospitals per cluster). It aims to assess the impact of Clean Cut on six critical perioperative infection prevention standards including antiseptic practices, antibiotic administration, and routine SCC use. The trial involves baseline data collection followed by Clean Cut training and implementation in each cluster in randomized order. The intervention consists of (1) modifying and implementing the SSC to fit local practices, (2) process mapping each standard, (3) coupling data and processes with site-specific action plans for improvement, and (4) targeted training focused on process gaps. The primary outcome is 30-day CS infection rates; secondary outcomes include other patient-level complications and compliance with standards. Assuming baseline SSI incidence of 12%, an effect size of 25% absolute reduction, and the ability to recruit 80-90 patients per cluster per month, we require a sample of 8100 patients for significance. We will report our study according to CONSORT. DISCUSSION: A cluster-randomized stepped wedge design is well-suited for evaluating this type of surgical safety program. The targeted standards are not in doubt, yet compliance is frequently difficult. Solutions are available and may be recognized by individuals, but teams dedicated to improvement are often lacking. Clean Cut was successfully piloted but requires a more rigorous methodological assessment. We seek to understand the qualities, characteristics, and resources needed to implement the program, the magnitude of effect on processes and outcomes, and to what degree it can enhance compliance with care standards. Challenges include a fraught social and political environment, pandemic travel restrictions, and a limited budget. TRIAL REGISTRATION: ClinicalTrials.gov NCT04812522 (registered on March 23, 2021); Pan-African Clinical Trials Registry PACTR202108717887402 (registered on August 24, 2021).