Substantial Practice Variation Research Articles

Prospective assessment of the impact of intraoperative diuretics in kidney transplant recipient surgery.

The use of intraoperative diuretics, such as furosemide or mannitol, during kidney transplantation has been suggested to reduce the rate of delayed graft function (DGF). The evidence base for this is sparse, however, and there is substantial variation in practice. We sought to evaluate whether the use of intraoperative diuretics during kidney transplantation translated into a reduction in DGF. We conducted a cohort study evaluating the use of furosemide or mannitol given intraoperatively before kidney reperfusion compared with control (no diuretic). Adult patients receiving a kidney transplant for end-stage renal disease were allocated to receive furosemide, mannitol, or no diuretic. The primary outcome was DGF; secondary outcomes were graft function at 30 days and perioperative changes in potassium levels. Descriptive and comparative statistics were used where appropriate. A total of 162 patients who received a kidney transplant from a deceased donor (either donation after neurologic determination of death or donation after circulatory death) were included over a 2-year period, with no significant between-group differences. There was no significant difference in DGF rates between the furosemide, mannitol, and control groups. When the furosemide and mannitol groups were pooled (any diuretic use) and compared with the control group, however, there was a significant improvement in the odds that patients would be free of DGF (odds ratio 2.10, 95% confidence interval 1.06-4.16, 26% v. 44%, p = 0.03). There were no significant differences noted in any secondary outcomes. This study suggests the use of an intraoperative diuretic (furosemide or mannitol) may result in a reduction in DGF in patients undergoing kidney transplantation. Further study in the form of a randomized controlled trial is warranted.

Cellulitis in the Emergency Department: A prospective cohort study with patient-centred follow-up.

There is substantial practice variation in the management of cellulitis with limited prospective studies describing the course of cellulitis after diagnosis. We aimed to describe the demographics, clinical features (erythema, warmth, swelling and pain), patient-reported disease trajectory and medium-term follow-up for ED patients with cellulitis. Prospective observational cohort study of adults diagnosed with cellulitis in two EDs in Southeast Queensland, Australia. Patients with (peri)orbital cellulitis and abscess were excluded. Data were obtained from a baseline questionnaire, electronic medical records and follow-up questionnaires at 3, 7 and 14 days. Clinician adjudication of day 14 cellulitis cure was compared to patient assessment. Descriptive analyses were conducted. Three-hundred patients (mean age 50 years, SD 19.9) with cellulitis were enrolled, predominantly affecting the lower limb (75%). Cellulitis features showed greatest improvement between enrolment and day 3. Clinical improvement continued gradually at days 7 and 14 with persistent skin erythema (41%) and swelling (37%) at day 14. Skin warmth was the feature most likely to be resolved at each time point. There was a discrepancy in clinician and patient assessment of cellulitis cure at day 14 (85.8% vs. 52.8% cured). A clinical response of cellulitis features can be expected at day 3 with ongoing slower improvement over time. Over one third of patients had erythema or swelling at day 14. Patients are less likely than clinicians to deem their cellulitis cured at day 14. Future research should include parallel patient and clinician evaluation of cellulitis to help develop clearer definitions of treatment failure and cure.

Temperature probe placement in very preterm infants during delivery room stabilization: an open-label randomized trial.

Variation in practice exists for temperature probe positioning during stabilization of very preterm infants (<32 weeks gestation). We explored the influence of temperature probe sites on thermoregulation. An open-label, stratified, balanced, parallel, randomized trial was conducted. Inborn infants were randomly assigned temperature probe to the axilla or to the upper back. The primary outcome was normothermia (local range: 36.8-37.3 °C and World Health Organization (WHO) range: 36.5-37.5 °C) at admission to the neonatal intensive care unit. Between 1 November 2018 and 4 July 2022, 178 infants were randomly assigned to one of the two sites (n = 89 each), 175 included in the final analysis. Normothermia (local range) was achieved for 39/87 infants (44.8%) assigned to the upper back compared to 28/88 infants (31.8%) assigned to the axilla [risk difference:13%; 95% CI -1.3-27.3]. Normothermia (WHO range) was achieved for 78/87 infants (89.7%) assigned to the upper back compared to 70/88 infants (79.6%) assigned to the axilla [risk difference:10.1%; 95% CI -0.5-20.7]. No infant recorded temperatures >38 °C or developed skin injury. In very preterm infants, upper back site was equally effective as the axilla in maintaining normothermia, with no increase in adverse events. The study was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12620000293965). Substantial variation in practice exists for the site of securing a temperature probe during delivery room stabilization of very preterm infants and the influence of temperature probe site on thermoregulation remains unknown. In this study, upper back site was equally effective as the axilla in maintaining normothermia, with no increase in adverse events. Clinicians could adopt upper back site for maintaining normothermia. This study may contribute data to future international participant data prospective meta analysis of randomized controlled trials worldwide on temperature probe positioning in very preterm infants, increasing translation of research findings to optimize thermoregulation and clinical outcomes.

The management of stage I Non-Small cell lung cancer (NSCLC) in Ontario: A Population-Based study of patterns of care and Stereotactic Ablative Body radiotherapy (SABR) utilization from 2010 to 2019

BackgroundStereotactic Ablative Body Radiotherapy (SABR) is the standard of care for medically inoperable patients with Stage I NSCLC. The adoption of SABR and its association with cancer outcomes requires characterization. AimWe described the management of biopsy-proven Stage I NSCLC with SABR, surgery, non-SABR curative radiotherapy (RT) and observation in Ontario, Canada, between 2010 and 2019. Temporal and geographic trends in practice and survival outcomes were analyzed. MethodsThis was a retrospective population-based cohort study conducted by linking electronic radiotherapy (RT) records to a population-based cancer registry. ResultsA total of 12,065 patients were identified, 61.7 % underwent surgery, 17.9 % received SABR, 8.6 % received non-SABR curative RT and 11.7 % were observed. Between 2010 and 2019, the utilization of surgery decreased (63.8 % to 49.9 %, p < 0.0001), while SABR use increased (7.5 % to 24.4 %, p < 0.0001), non-SABR curative RT use increased (6.7 % to 9.6 %, p < 0.0014) and patients observed decreased (14.4 % to 12.0 %, p < 0.0001). Substantial variation in practice exists across Ontario. Two- yr CSS improved for the entire cohort (81.9 % to 85.0 %, p < 0.0001). While there was improvement in 2 yr CSS for surgical patients (92.1 %% to 95.7 %, p < 0.001), survival for patients who received SABR, Non-SABR curative RT and observation remained stable. ConclusionThere has been an increase in SABR utilization and a reduction in surgical utilization with a corresponding increased survival of stage I patients in Ontario between 2010 and 2019. Substantial differences in practice patterns exist across health regions, suggesting the need for strategies to improve access to SABR in many jurisdictions.

Organization of head and neck cancer rehabilitation care: a national survey among healthcare professionals in Dutch head and neck cancer centers

PurposeHead and neck cancer (HNC) treatment often leads to physical and psychosocial impairments. Rehabilitation can overcome these limitations and improve quality of life. The aim of this study is to obtain an overview of rehabilitation care for HNC, and to investigate factors influencing rehabilitation provision, in Dutch HNC centers, and to some extent compare it to other countries.MethodsAn online survey, covering five themes: organizational structure; rehabilitation interventions; financing; barriers and facilitators; satisfaction and future improvements, among HNC healthcare- and financial professionals of Dutch HNC centers.ResultsMost centers (86%) applied some type of rehabilitation care, with variations in organizational structure. A speech language therapist, physiotherapist and dietitian were available in all centers, but other rehabilitation healthcare professionals in less than 60%. Facilitators for providing rehabilitation services included availability of a contact person, and positive attitude, motivation, and expertise of healthcare professionals. Barriers were lack of reimbursement, and patient related barriers including comorbidity, travel (time), low health literacy, limited financial capacity, and poor motivation.ConclusionAlthough all HNC centers included offer rehabilitation services, there is substantial practice variation, both nationally and internationally. Factors influencing rehabilitation are related to the motivation and expertise of the treatment team, but also to reimbursement aspects and patient related factors. More research is needed to investigate the extent to which practice variation impacts individual patient outcomes and how to integrate HNC rehabilitation into routine clinical pathways.

Privacy and confidentiality in Massachusetts' post-overdose outreach programs: Mixed methods analysis of outreach staff surveys and interviews

BackgroundPublic health-public safety partnerships for post-overdose outreach have emerged in many communities to prevent future overdose events. These efforts often identify overdose survivors through emergency call data and seek to link them with relevant services. The aim of this study was to describe how post-overdose outreach programs in Massachusetts manage the confidentiality of identifiable information and privacy of survivors. MethodsIn 2019, 138 Massachusetts programs completed surveys eliciting responses to questions about program operations. Descriptive statistics were calculated from the closed-ended survey responses. Thirty-eight interviews were conducted among outreach staff members during 2019–2020. Interview transcripts and open-ended survey responses were thematically analyzed using deductive and inductive approaches. ResultsOf programs that completed the survey, 90 % (n = 124/138) reported acting to protect the privacy of survivors following overdose events, and 84 % (n = 114/135) reported implementing a protocol to maintain the confidentiality of personal information. Interviews with outreach team members indicated substantial variation in practice. Outreach programs regularly employed discretion in determining actions in the field, sometimes undermining survivor privacy and confidentiality (e.g., by disclosing the overdose event to family members). Programs aiming to prioritize privacy and confidentiality attempted to make initial contact with survivors by phone, limited or concealed materials left behind when no one was home, and/or limited the number of contact attempts. ConclusionsDespite the establishment of privacy and confidentiality protocols within most post-overdose outreach programs, application of these procedures was varied, discretionary, and at times viewed by staff as competing with engagement efforts. Individual outreach overdose teams should prioritize privacy and confidentiality during outreach to protect overdose survivors from undesired exposure. In addition to individual program changes, access to overdose survivor information could be changed across all programs to bolster privacy and confidentiality protocols. For example, transitioning the management of overdose-related information to non-law enforcement agencies would limit officers’ ability to disseminate such information at their discretion.

Use of pudendal nerve blocks in rubber band ligation of haemorrhoids: an Australia-wide cross-sectional analysis.

Surgeons vary in their approach to preventing pain post rubber band ligation (RBL) of haemorrhoids, with pudendal nerve blocks (PNB) being one analgesic strategy. No data exists on how commonly PNBs are used in RBL in Australia, and whether use varies by year and patient and hospital characteristics. Aggregate data from the National Hospital Morbidity Database was obtained for all admissions for RBL in Australia from 2012 to 2021, with and without a PNB, overall and in relation to sex, age group, hospital remoteness, hospital sector, and year of procedure. Adjusted relative risks (adj. RR) of PNB were estimated using Poisson regression, mutually adjusting for all variables. Of the 346 542 admissions for RBL, 14013 (4.04%) involved a PNB. The proportion of patients receiving a PNB increased between 2012-2013 and 2020-2021, from 1.62% to 6.63% (adj. RR 3.99, CI 3.64-4.36). Patients most likely to receive a PNB were female (adj. RR 1.10; CI 1.07-1.14) aged 25-34 years (adj. RR 1.13; CI 1.01-1.26); in major-city (adj. RR 1.25 CI 1.20-1.30) and private hospitals (adj. RR 3.28 CI 3.13-3.45). This is the first published analysis of the use of PNB in RBL. Pudendal nerve block use has increased over time, with substantial variation in practice. Blocks were more than three times as likely to be used in private compared to public hospitals. If evidence supporting PNB use is established, equitable access to the procedure should be pursued.

A feasibility survey to inform trial design investigating surgical site infection prevention in vascular surgery

Introduction: Current surgical site infection (SSI) prevention guidance indicates low-quality evidence supporting many of their recommendations. Subsequently, there is substantial variation in practice and often implementation of unsubstantiated interventions. There is therefore a need to rapidly evaluate best practices to prevent SSI. This survey aimed to evaluate current practice in the prevention of SSI and equipoise regarding potential interventions to reduce SSI rates in major lower limb amputation (MLLA) and groin incisions. Methods: A cross-sectional national survey was developed from current international guidelines to prevent SSI, following CHERRIES and CROSS checklists. A study steering committee directed internal validation prior to dissemination via single stage sampling of the membership of the Vascular Society of Great Britain and Ireland. Results: The survey received 58 responses from clinicians across 38 NHS trusts. Most respondents were consultant vascular surgeons (91%; 53/58). Preoperatively, there was variable practice in the use of preoperative bathing, surgical site preparation, antibiotic prophylaxis duration and the use of incise drapes for both MLLA and groin incisions. Intraoperatively there was little consensus for wound irrigation, drain insertion, changing gloves and instruments prior to skin closure, skin closure technique, and the use of dressings for both MLLA and groin incisions. The majority of respondents were willing to randomise patients to most interventions. Nearly three-quarters (72%; 42/58) of respondents agreed or strongly agreed that a combined outcome measure of SSI and wound dehiscence would be the ideal primary outcome in a trial investigating SSI prevention in MLLA. Conclusions: Despite significant heterogeneity in practice to prevent SSI, the majority of surgeons surveyed showed they would be willing to randomise to interventions in a randomised controlled trial. This key finding is important in the design of future studies.

Second and Third Kidney Transplants.

Renal transplant is the best procedure for patients with end-stage renal disease. Although an ideal kidney transplant should survive for the lifetime of each recipient, there may be a need for a second, third, or even a fourth retransplant. The outcomes of these kidney allografts, surgical approaches, immunology issues, and drug therapies warrant greater focus. Pediatric kidney retransplant is even more important because these patients are more immunologically responsive to donor antigens and because they need longer allograft survival. Although kidney retransplant provides a survival advantage for patients who would otherwise remain on the wait list and/or hemodialysis, careful patient selection is crucial for second, third, and fourth renal transplants. Despite the shortage of donor organs, outcomes, manageable complications, and economic considerations support earlier kidney retransplants rather than delayed retransplants. Preoperative vascular imaging, appropriate induction therapy, regular monitoring of renal function, and regular surveillance for malignancy and infection are more important in the retransplanted kidneys than in cases of first kidney transplants. The lack of robust data on optimal clinical management of these retransplant recipients has contributed to substantial variations in clinical practice among different centers. In this review, we discuss medical and surgical approaches in the cases of second and third kidney transplants.

Short Course Adjuvant Vaginal Cuff Brachytherapy (VCB) in Early Endometrial Cancer: Primary Endpoint Results of the SAVE Randomized Clinical Trial

Prospective trials in early stage endometrial cancer demonstrate increased locoregional control with adjuvant radiotherapy for patients with high risk features. VCB is widely utilized, yet there is substantial practice variation and limited randomized data examining optimal dose/fractionation. We aimed to study the safety and efficacy of short course VCB compared to commonly used regimens. We conducted a prospective, randomized, multicenter trial examining short course adjuvant VCB (11 Gy x 2 fractions at the surface) compared with other standard regimens (7 Gy x 3 fractions at 0.5 cm depth, 6 Gy x 5 fractions at the surface, or 5-5.5 Gy x 4 fractions at 0.5 cm depth). Eligible patients underwent hysterectomy and had pathologically confirmed endometrioid adenocarcinoma, serous, clear cell, or carcinosarcoma. Patients with stage I and II cancers were included, with lymphovascular invasion (LVI) required for stage IAG1. The primary outcome was Global Health Status measured by the EORTC QLQ-C30 with a pre-specified non-inferiority margin of 15 points. Secondary outcomes included patient-reported outcomes, toxicities as assessed by CTCAEv5, and patterns of recurrence. Data were collected at each brachytherapy fraction and at 1-, 6-, and 12-month follow-up. One hundred eight patients were enrolled, 54 in each study arm. Data completion was 94%, 91%, and 77% at 1 month, 6 months, and 12 months, respectively. 70% of patients had endometrioid adenocarcinoma, 18% serous carcinoma, and 12% other histologies. 23% were FIGO grade 1, 33% grade 2, and 43% grade 3 or high risk histologies. The majority of patients were stage I (56% IA, 38% IB). 22% of patients had LVI. The QLQ-C30 Global Health Status for the experimental arm was within the predefined boundary and thus 2 fractions were non-inferior to standard of care at one month (p = 0.000005) and 12 months (p = 0.0005). Using EORTC EN24 for patient reported vaginal/sexual, urologic, and gastrointestinal symptoms, the change in mean patient reported symptom score from baseline to 1 month and baseline to 12 months were not significantly different between arms. Using CTCAEv5, 51 patients experienced short-term AEs related to study treatment, 20 in the experimental arm and 31 in the control arm (p = 0.053). All study treatment-related AEs were grade 1-2, except for two grade 3-4 AEs, both on the control arm. At median follow-up of 19 months, the isolated vaginal control rate in each arm was 100%. There was no significant difference in the total number of recurrences between study arms, with 3 distant and 3 distant/pelvic/vaginal recurrences in the experimental arm, and 2 distant, 2 pelvic, and 1 pelvic/vaginal recurrence in the control arm. Short course VCB is safe with acceptable acute toxicity and non-inferior patient reported outcomes. Short course VCB improves patient convenience and may improve access to care for rural or underserved populations while providing similar local control.

Critical Emergency Department Interventions and Clinical Deterioration in Children With Nonsevere Traumatic Intracranial Hemorrhage.

Substantial practice variation exists in the management of children with nonsevere traumatic intracranial hemorrhage (tICH). A comprehensive understanding of rates and timing of clinically important tICH, including critical interventions and deterioration, along with associated clinical and neuroradiographic characteristics, will inform accurate risk stratification. We conducted a single-center retrospective cohort study of children aged younger than 18 years evaluated in the emergency department (ED) from May 1, 2014 to February 28, 2020 with tICH and initial Glasgow Coma Scale (GCS) score of higher than 8. We determined rates of clinically important tICH after injury and within 96 hours of ED arrival, defined as immediate ED interventions (intubation, hyperosmotic agents, or neurosurgery within 4 hours of arrival) or clinically important deterioration (signs/symptoms with change in management). Associations between outcome and clinical and neuroradiographic characteristics were calculated using individual logistic regression models. Our sample included 135 children. Clinically important tICH was observed in 13.3% (n = 18); 9 (6.7%) underwent immediate ED interventions and 9 (6.7%) developed deterioration. Most (93.3%, n = 127) presented with an initial GCS ≥ 14, including all children who later deteriorated. Initial GCS (P = 0.001) and nonaccidental trauma (P = 0.024) mechanism were associated with the outcome. None of the 71 (52.6%) children with initial GCS ≥ 14, isolated, nonepidural hemorrhage after accidental injury developed clinically important tICH. Clinically important tICH occurred in 13% of children with nonsevere tICH, and 7% of children who did not undergo immediate ED interventions later deteriorated, all of whom had an initial GCS ≥ 14. However, a subgroup of children was identified as low risk based on clinical and neuroradiographic characteristics.

Impact of consensus guideline publication on the timing of elective pediatric umbilical hernia repair

BackgroundThe American Academy of Pediatrics published consensus guidelines advising observation of asymptomatic umbilical hernias until age 4 or 5, given unnecessary risks of early intervention and substantial practice variation. Yet, the impact of guidelines on early repair (age <4) or if certain groups remain at risk for avoidable intervention is unclear. MethodsThis retrospective study used data from children’s hospitals participating in the Pediatric Health Information System database. Children aged 17 years and younger who underwent umbilical hernia repair from July 2017 to August 2022 were eligible for inclusion. Children with recurrent hernias, an emergency, or urgent presentation were excluded. An interrupted time series using segmented multivariable logistic regression estimated the association of guideline publication in November 2019 with the odds of guideline-adherent repair (age ≥4) after adjusting for sociodemographic characteristics and hospital-level random effects. Results16,544 children underwent repair, of which 3,115 (18.8%) were children <4 years old. After adjustment, guideline publication was associated with an immediate increase in guideline-adherent repairs (odds ratio = 1.25 95% confidence interval = 1.05–1.49). The interrupted time series found that each month after publication was associated with a 2% increase in the odds of guideline-adherent repair (odds ratio = 1.02, 95% confidence interval = 1.01–1.03). Children with public insurance were nearly 20% less likely to receive guideline-adherent repair than privately insured children (odds ratio = 0.82, 95% confidence interval = 0.74–0.91). Children in the Midwest had lower odds of guideline-adherent repair (Midwest versus Northeast: odds ratio = 0.45. 95% confidence interval = 0.24–0.84). ConclusionGuideline publication was associated with greater odds of guideline-adherent repair, yet public insurance coverage and Midwest location remain significant predictors of early repair against recommendations.

Comparative effectiveness of decompressive craniectomy versus craniotomy for traumatic acute subdural hematoma (CENTER-TBI): an observational cohort study

Limited evidence existed on the comparative effectiveness of decompressive craniectomy (DC) versus craniotomy for evacuation of traumatic acute subdural hematoma (ASDH) until the recently published randomised clinical trial RESCUE-ASDH. In this study, that ran concurrently, we aimed to determine current practice patterns and compare outcomes of primary DC versus craniotomy. We conducted an analysis of centre treatment preference within the prospective, multicentre, observational Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (known as CENTER-TBI) and NeuroTraumatology Quality Registry (known as Net-QuRe) studies, which enrolled patients throughout Europe and Israel (2014-2020). We included patients with an ASDH who underwent acute neurosurgical evacuation. Patients with severe pre-existing neurological disorders were excluded. In an instrumental variable analysis, we compared outcomes between centres according to treatment preference, measured by the case-mix adjusted proportion DC per centre. The primary outcome was functional outcome rated by the 6-months Glasgow Outcome Scale Extended, estimated with ordinal regression as a common odds ratio (OR), adjusted for prespecified confounders. Variation in centre preference was quantified with the median odds ratio (MOR). CENTER-TBI is registered with ClinicalTrials.gov, number NCT02210221, and the Resource Identification Portal (Research Resource Identifier SCR_015582). Between December 19, 2014 and December 17, 2017, 4559 patients with traumatic brain injury were enrolled in CENTER-TBI of whom 336 (7%) underwent acute surgery for ASDH evacuation; 91 (27%) underwent DC and 245 (63%) craniotomy. The proportion primary DC within total acute surgery cases ranged from 6 to 67% with an interquartile range (IQR) of 12-26% among 46 centres; the odds of receiving a DC for prognostically similar patients in one centre versus another randomly selected centre were trebled (adjusted median odds ratio 2.7, p<0.0001). Higher centre preference for DC over craniotomy was not associated with better functional outcome (adjusted common odds ratio (OR) per 14% [IQR increase] more DC in a centre=0.9 [95% CI 0.7-1.1], n=200). Primary DC was associated with more follow-on surgeries and complications [secondary cranial surgery 27% vs. 18%; shunts 11 vs. 5%]; and similar odds of in-hospital mortality (adjusted OR per 14% IQR more primary DC 1.3 [95% CI (1.0-3.4), n=200]). We found substantial practice variation in the employment of DC over craniotomy for ASDH. This variation in treatment strategy did not result in different functional outcome. These findings suggest that primary DC should be restricted to salvageable patients in whom immediate replacement of the bone flap is not possible due to intraoperative brain swelling. Hersenstichting Nederland for the Dutch NeuroTraumatology Quality Registry and the European Union Seventh Framework Program.

Continuation of enteral nutrition until extubation in critically ill patients.

There is substantial variation in enteral nutrition practices for airway procedures in critically ill patients across individual specialists and intensive care units (ICUs). Fasting times can vary between 0 h and longer than 24 h before planned extubations. 1 Varghese JA Tatucu-Babet OA Miller E et al. Fasting practices of enteral nutrition delivery for airway procedures in critically ill adult patients: a scoping review. J Crit Care. 2022; 72154144 Crossref PubMed Scopus (0) Google Scholar Patients receiving mechanical ventilation are often underfed, and interruptions are one of the main causes that energy prescriptions are not met. 2 Torrini F Gendreau S Morel J et al. Prediction of extubation outcome in critically ill patients: a systematic review and meta-analysis. Crit Care. 2021; 25: 391 Crossref PubMed Scopus (11) Google Scholar Airway procedures, such as extubation or tracheotomy, lead to the longest fasting periods in the ICU, but the implementation of unit-wide guidelines can reduce fasting time and maximise caloric intake. 3 Segaran E Barker I Hartle A Optimising enteral nutrition in critically ill patients by reducing fasting times. J Intensive Care Soc. 2016; 17: 38-43 Crossref PubMed Scopus (26) Google Scholar , 4 Hoffmann M Schwarz CM Fürst S et al. Risks in management of enteral nutrition in intensive care units: a literature review and narrative synthesis. Nutrients. 2020; 13: 82 Crossref PubMed Scopus (4) Google Scholar However, most of this common practice comes from the theatre, and mainly preoperative fasting practice guidelines are being used with the hope of minimising the risk of aspiration in airway procedures. 5 Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of Anesthesiologists task force on preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration. Anesthesiology. 2017; 126: 376-393 Crossref PubMed Scopus (450) Google Scholar Patients are at increased risk of aspiration due to oropharyngeal dysfunction for several hours following extubation 6 Schefold JC Berger D Zürcher P et al. Dysphagia in mechanically ventilated ICU patients (DYnAMICS): a prospective observational trial. Crit Care Med. 2017; 45: 2061-2069 Crossref PubMed Scopus (95) Google Scholar and up to 20% of patients have to be reintubated within 7 days. 2 Torrini F Gendreau S Morel J et al. Prediction of extubation outcome in critically ill patients: a systematic review and meta-analysis. Crit Care. 2021; 25: 391 Crossref PubMed Scopus (11) Google Scholar A question that remained unanswered was whether it is really safe to continue enteral nutrition until attempting to extubate. Continued enteral nutrition until extubation compared with fasting before extubation in patients in the intensive care unit: an open-label, cluster-randomised, parallel-group, non-inferiority trialContinued enteral nutrition until extubation in critically ill patients in the intensive care unit was non-inferior to a 6-h fasting maximum gastric vacuity strategy comprising continuous gastric tube suctioning, in terms of extubation failure within 7 days (a patient-centred outcome), and thus represents a potential alternative in this population. Full-Text PDF

Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study

BackgroundExisting guidelines recommend statisticians remain blinded to treatment allocation prior to the final analysis and that any interim analyses should be conducted by a separate team from the one undertaking the final analysis. However, there remains substantial variation in practice between UK Clinical Trials Units (CTUs) when it comes to blinding statisticians. Therefore, the aim of this study was to develop guidance to advise CTUs on a risk-proportionate approach to blinding statisticians within clinical trials.MethodsThis study employed a mixed methods approach involving three stages: (I) a quantitative study using a cohort of 200 studies (from a major UK funder published between 2016 and 2020) to assess the impact of blinding statisticians on the proportion of trials reporting a statistically significant finding for the primary outcome(s); (II) a qualitative study using focus groups to determine the perspectives of key stakeholders on the practice of blinding trial statisticians; and (III) combining the results of stages I and II, along with a stakeholder meeting, to develop guidance for UK CTUs.ResultsAfter screening abstracts, 179 trials were included for review. The results of the primary analysis showed no evidence that involvement of an unblinded trial statistician was associated with the likelihood of statistically significant findings being reported, odds ratio (OR) 1.02 (95% confidence interval (CI) 0.49 to 2.13). Six focus groups were conducted, with 37 participants. The triangulation between stages I and II resulted in developing 40 provisional statements. These were rated independently by the stakeholder group prior to the meeting. Ten statements reached agreement with no agreement on 30 statements. At the meeting, various factors were identified that could influence the decision of blinding the statistician, including timing, study design, types of intervention and practicalities. Guidance including 21 recommendations/considerations was developed alongside a Risk Assessment Tool to provide CTUs with a framework for assessing the risks associated with blinding/not blinding statisticians and for identifying appropriate mitigation strategies.ConclusionsThis is the first study to develop a guidance document to enhance the understanding of blinding statisticians and to provide a framework for the decision-making process. The key finding was that the decision to blind statisticians should be based on the benefits and risks associated with a particular trial.

Survey of transfusion practices in preterm infants in Europe

BackgroundPreterm infants commonly receive red blood cell (RBC), platelet and fresh frozen plasma (FFP) transfusions. The aim of this Neonatal Transfusion Network survey was to describe current transfusion practices in...

Sedation Prior to Intubation at Birth in Infants with Congenital Diaphragmatic Hernia: An International Survey on Current Practices

Introduction: Infants with congenital diaphragmatic hernia (CDH) are commonly intubated immediately after birth. Consensus on whether to provide sedation prior to intubation in the delivery room is lacking, although avoidance of stress is especially important in this population with high risk of pulmonary hypertension. We aimed at obtaining an overview of local pharmacological interventions and at providing guidance on delivery room management. Methods: An electronic survey was sent to international clinicians in referral centres for prenatal and postnatally diagnosed infants with CDH. This survey addressed demographic information, use of sedation and/or muscle relaxant prior to intubation, and use of pain scales in the delivery room. Results: We received 93 relevant responses from 59 centres. Most centres were from Europe (n = 33, 56%), followed by North America (n = 16, 27%), Asia (n = 6, 10%), Australia (n = 2, 3%), and South America (n = 2, 3%). A total of 19% (11/59) of the centres routinely provided sedation prior to intubation in the delivery room, with midazolam and fentanyl being most often used. Methods of administration varied for all medications provided. Only 5 of 11 centres using sedation reported an adequate sedative effect prior to intubation. Muscle relaxants prior to intubation were used in 12% (7/59) of the centres, although not always in combination with sedation. Conclusion: This international survey shows a substantial variation in sedation practices in the delivery room and scarce use of both sedative agents and muscle relaxants prior to intubation of CDH infants. We provide guidance on developing protocols for pre-intubation medication in this population.

The variable role of damage control laparotomy over 19 years of trauma care in Pennsylvania

BackgroundDamage control laparotomy emphasizes physiologic stabilization of critically injured patients and allows staged surgical management. However, there is little consensus on the optimal criteria for damage control laparotomy. We examined variability between centers and over time in Pennsylvania. MethodsWe analyzed the Pennsylvania Trauma Outcomes Study data between 2000 and 2018, excluding centers performing <10 laparotomies/year. Laparotomy was defined using International Classification of Diseases codes, and damage control laparotomy was defined by a code for “reopening of recent laparotomy” or a return to the operating room >4 hours from index laparotomy that was not unplanned. We examined trends over time and by center. Multivariable logistic regression models were developed to predict both damage control laparotomy and mortality, generate observed:expected ratios, and identify outliers for each. We compared risk-adjusted mortality rates to center-level damage control laparotomy rates. ResultsIn total, 18,896 laparotomies from 22 centers were analyzed; 3,549 damage control laparotomies were performed (18.8% of all laparotomies). The use of damage control laparotomy in Pennsylvania varied from 13.9% to 22.8% over time. There was wide variation in center-level use of damage control laparotomy, from 11.1% to 29.4%, despite adjustment. Factors associated with damage control laparotomy included injury severity and admission vital signs. Center identity improved the model as demonstrated by likelihood ratio test (P < .001), suggesting differences in center-level practices. There was minimal correlation between center-level damage control laparotomy use and mortality. ConclusionThere is wide center-level variation in the use of damage control laparotomy among centers, despite adjustment for patient factors. Damage control laparotomy is both resource intensive and highly morbid; regional resources should be allocated to address this substantial practice variation to optimize damage control laparotomy use.

Wayfinding through the "ocean of the great unknown": how lactating parents establish a direct breastfeeding relationship with an infant with critical CHD.

Lactating parents of infants hospitalised for critical congenital heart disease (CHD) face significant barriers to direct breastfeeding. While experiences of directly breastfeeding other hospitalised neonates have been described, studies including infants with critical CHD are scarce. There is no evidence-based standard of direct breastfeeding care for these infants, and substantial practice variation exists. To explain how direct breastfeeding is established with an infant hospitalised for critical CHD, from lactating parents' perspectives. This study is a qualitative grounded dimensional analysis of interviews with 30 lactating parents of infants with critical CHD who directly breastfed within 3 years. Infants received care from 26 United States cardiac centres; 57% had single ventricle physiology. Analysis included open, axial, and selective coding; memoing; member checking; and explanatory matrices. Findings were represented by a conceptual model, "Wayfinding through the 'ocean of the great unknown'." The core process of Wayfinding involved a nonlinear trajectory requiring immense persistence in navigating obstacles, occurring in a context of life-and-death consequences for the infant. Wayfinding was characterised by three subprocesses: navigating the relationship with the healthcare team; protecting the direct breastfeeding relationship; and doing the long, hard work. Primary influencing conditions included relentless concern about weight gain, the infant's clinical course, and the parent's previous direct breastfeeding experience. For parents, engaging in the Wayfinding process to establish direct breastfeeding was feasible and meaningful - though challenging. The conceptual model of Wayfinding explains how direct breastfeeding can be established and provides a framework for research and practice.

STEMI Pakistan; A National Heart Attack Management Program.

Coronary artery disease (CAD) accounts for more than two-thirds of these deaths. It is indicated per the latest information that one in four Pakistani adults over 40 has CAD.&#x0D; The stable coronary disease has a relatively low annual mortality, while acute myocardial infarction (MI) carries a high mortality and morbidity. Though recent advancements in coronary interventions have however revolutionized the management of acute myocardial infarction, resulting in a significant reduction of cardiovascular morbidity and mortality in the developed world but in Pakistan, the majority of ST-elevation myocardial infarction (STEMI) patients still remain sub-optimally managed. Urban areas are relatively better equipped, but this does not necessarily translate into universal access to quality and timely cardiac care. There is not only substantial variation in accessibility and practices amongst cardiac healthcare facilities between rural and urban areas but also amongst major city hospitals. Such variations clearly indicate an urgent need for a nationwide standardized STEMI management program to ensure that everyone with an acute STEMI will have speedy access to quality and standard acute care without being economically burdened.