Background The Sugammadex for preventIoN oF pOst-operative pulmoNary complIcAtions (SINFONIA) trial is a multi-centre, pragmatic, randomised superiority trial comparing sugammadex with neostigmine to reverse neuromuscular block after major abdominal or thoracic surgery. Neuromuscular blocking agents are routinely administered during general anaesthesia to facilitate intubation, ventilation, and surgical access. Residual neuromuscular block remains common despite reversal and is associated with increased risk of post-operative pulmonary complications. Sugammadex reduces residual paralysis compared with neostigmine, but its effect on patient-centred outcomes remains uncertain, and clinical equipoise persists. As intervention delivery is embedded within complex intra-operative decision-making, variation in implementation may influence trial outcomes. An embedded process evaluation will characterise intervention delivery and identify contextual and organisational factors influencing implementation across sites. This protocol describes the rationale, aims, and methods of the SINFONIA process evaluation. Methods This embedded mixed-methods process evaluation is informed by the PrOcess Evaluation of Trials In Critical care (POETIC) framework, examining Context, Fidelity, Dose, Reach, and Quality of Delivery. A logic model was developed, describing relationships between contextual factors, intervention delivery and trial outcomes. An explanatory sequential design will first analyse quantitative data describing intervention delivery, followed by qualitative data explaining observed variation. Data will be collected via electronic survey and semi-structured interviews, with findings integrated with the main trial results. Discussion This embedded process evaluation will characterise SINFONIA intervention delivery across sites, explain how contextual factors shape implementation, and support interpretation of trial findings through integrated process evaluation evidence. Clinical trial registration ISRCTN.com ISRCTN15109717. Registered on 21 December 2022.
Background:Cardiac surgery carries substantial risks of perioperative complications and mortality; however, outcome data from low- and middle-income countries are scarce. This prospective observational cohort study conducted across 11 Brazilian hospitals aimed to determine the incidence of early mortality and major postoperative complications in patients undergoing cardiac surgery in Brazil. Methods:Adults (≥18 yr) undergoing coronary, valvular, or percutaneous cardiac surgery requiring postoperative ICU admission, excluding patients under exclusive palliative care, device implantation only, or moribund before surgery. Risk factors and incidence of mortality or severe postoperative complications within the first 3 postoperative days or until ICU discharge (whichever occurs first). Risk factors were assessed using generalised linear mixed-effects models, reported as odds ratios with 95% confidence intervals. Results:Between September 2023 and March 2025, 528 patients were enrolled. Among 528 patients (91% open-heart, mainly coronary artery bypass grafting and valve replacements), 170 (32%) experienced early mortality or severe postoperative complications, most within the first 24 h. The most frequent complications were severe haemodynamic instability (126, 24%), and acute respiratory distress syndrome (71, 13%). Most events occurred on the day of ICU admission (132 of 170, 78%). Risk factors of the primary outcome were prior stroke (3.22 [1.02-10.17], P=0.046), preoperative thrombocytopenia (2.83 [1.46-5.48], P=0.002), open-heart surgery (6.34 [1.66-24.21], P=0.007), biological valves (3.94 [1.18-11.31] P=0.026). Early postoperative markers of clinical deterioration were higher Sequential Organ Failure Assessment score on day 0 (1.35 [1.19-1.53], P<0.001), lower arterial pH on day 0 (0.53 [0.34-0.83], P=0.006), and vasoplegia (15.35 [6.05-38.94], P<0.001). Conclusions:In this multicentre cohort of cardiac surgery patients in Brazil, one in three experienced early mortality or severe postoperative complications, mostly within the first 24 h. Identified predictors of early postoperative deterioration may help guide perioperative strategies and underscore the need for developing prognostic models adapted to local contexts. Clinical trial registration:NCT06154473.
Background:Myocardial injury after noncardiac surgery is common, is frequently clinically silent, and arises from heterogeneous mechanisms. Whether structured aetiological assessment using an existing hierarchical framework is applicable in high-risk patients remains uncertain. The primary aim of this study was to determine the aetiological distribution of myocardial injury in a selectively tested high-risk cohort. Methods:This single-centre retrospective cohort study included adults undergoing noncardiac surgery during the years 2017 to 2022. Myocardial injury is defined as a high-sensitivity cardiac troponin T concentration >50 ng L-1 within 72 h after surgery. Troponin was measured in selected high-risk patients, either routinely or at physician discretion. The primary outcome was aetiological distribution, classified by anaesthetists as extra-cardiac or cardiac, using an existing hierarchical adjudication model. Secondary outcomes were inter-rater agreement after independent reassessment and in-hospital mortality. Results:Of 6263 patients sampled, 1114 (18%) were diagnosed as having myocardial injury and 954 were analysed. Myocardial injury was classified as extra-cardiac in 544 (57%) and cardiac in 410 patients (43%). Renal failure was the most common extra-cardiac cause (37%) and type 2 myocardial injury the most common cardiac cause (81%). Patients with extra-cardiac injury more often underwent non-elective surgery (78% vs 55%; P<0.001). Inter-rater agreement after reassessment was 78% (κ=0.55), with discrepancies mainly in type 2 myocardial injury. In-hospital mortality in this high-risk cohort was 20% overall, 24% in those with extra-cardiac injury, and 15% in those with cardiac myocardial injury (P=0.002). Conclusions:In this single-centre high-risk noncardiac surgical cohort, pragmatic aetiological assessment attributed myocardial injury more often to extra-cardiac mechanisms, which were associated with higher in-hospital mortality. Limited by selective postoperative troponin sampling, these findings warrant future research into the prognostic value of troponin elevations across differing aetiologies.
Background:Hypothermia is common in patients admitted to the ICU after surgery; however, its relationship with postoperative outcomes has not been fully explored. This study investigates the association between postoperative hypothermia in the ICU and patient mortality. Methods:Retrospective cohort study using the Australian and New Zealand Intensive Care Society adult patient database. Postoperative noncardiac surgical ICU admissions between 2018 and 2023 were included. Hypothermia was defined as temperature <36°C. The lowest temperature recorded within the first 24 hours of ICU admission was used. The primary outcome was in hospital mortality with secondary outcomes including ICU mortality rate, length of stay and ICU readmission rates. Descriptive and multivariable logistic regression models were used to investigate the relationship between postoperative temperature and mortality. Results:Of 425,648 postoperative admissions to the ICU, 165,111 (38.8%) experienced hypothermia within 24 h of their admission. Patients with hypothermia had higher hospital mortality rates of 4.3%, compared with 2.1% in the normothermia group (adjusted odds ratio 1.34; 95% confidence interval 1.28-1.39). Mortality rates increased with lower temperatures with the 32-32.9°C group experiencing the highest mortality rate (adjusted odds ratio 3.03; 95% confidence interval 2.30-4.00). ICU readmission rates and hospital and ICU length of stay were similar between groups. Conclusions:In this retrospective cohort study we report that ostoperative hypothermia in the ICU setting is common in Austrailia and New Zealand and was associated with an increased mortality rate. Early recognition and prevention of hypothermia in the intensive care setting may be a modifiable risk factor to reduce mortality for this patient cohort.
Background Clinician well-being is essential for healthcare sustainability. Burnout and intention to leave remain prevalent in anaesthesiology, yet scalable, evidence-based systems-level interventions are limited. This study aimed to evaluate the impact of a pragmatic, clinician-driven departmental intervention designed to improve daily work experience. We hypothesised that this intervention would reduce burnout and improve related measurements of clinician well-being. Methods This mixed-methods study assessed the Pain Point Elimination Bringing Better Longitudinal Engagement and Satisfaction (PEBBLES) project across two US paediatric anaesthesiology departments over a 14 month period. Participants engaged in facilitated small-group sessions identifying actionable workplace issues that were iteratively addressed with structured feedback. Impact was assessed using both process measures (post-intervention qualitative focus groups analysed with a combined deductive and inductive thematic approach) and outcome measures (pre- and post-intervention quantitative measures of clinician well-being) to provide a comprehensive evaluation. Burnout was defined as the mean of work exhaustion and interpersonal disengagement as measured by the professional fulfilment index, where higher scores indicate greater burnout. Results Between April 2023 and June 2024, 75 clinicians participated. Within the matched participants subgroup, interpersonal disengagement decreased significantly at both 3 and 6 months compared with baseline. Overall burnout increased at 3 months but was not different from baseline by 6 months. Work exhaustion decreased significantly at 6 months. Other well-being metrics remained stable. At 12 months, 83.9% reported participation was worthwhile, and 87.1% would recommend the intervention. Qualitative analyses yielded three major themes: increased perceived agency in the local work environment, enhanced perceptions of being valued, and learned hopefulness that seemed to counter cynicism. Conclusions The PEBBLES intervention was associated with improvements in disengagement and work exhaustion alongside meaningful experiential gains in agency, valuation, and hopefulness. These findings support the feasibility of low-cost, clinician-driven system interventions as practical components of organisational well-being and workforce retention strategies.
Background:Cardiovascular complications are a leading cause of perioperative adverse outcomes, particularly in patients with pre-existing cardiovascular disease. Anaesthesiologists routinely assess cardiovascular risk preoperatively, yet the use of cardiovascular magnetic resonance (CMR) findings in this context remains unclear. This study evaluated how anaesthesiologists perceive and use preexisting CMR findings for perioperative risk evaluation. Methods:We conducted an online survey for anaesthesiologists. The primary endpoint was incorporation of CMR findings into perioperative decision-making, with secondary analyses examining factors associated with CMR use and understanding of CMR parameters. Results:A total of 455 anaesthesiologists from 32 countries completed the survey. Most were board certified (84%), and 56% indicated cardiovascular or thoracic anaesthesiology (CVA) as a clinical activity. Overall, 68% reported incorporating findings from CMR reports for perioperative risk assessment at least sometimes, with no difference in use between respondents specialising in CVA and those who do not (69% vs 67%; odds ratio 1.17 [95% confidence interval 0.84-1.63]; P=0.36). Although left ventricular anatomy and function were widely incorporated (72%), understanding of advanced tissue characterisation markers was limited, particularly among non-CVA anaesthesiologists. Notably, 74% agreed that CMR holds potential for perioperative risk evaluation, and 54% expressed interest in its future integration. Conclusions:Among respondents to this voluntary survey, CMR findings were frequently reported as being incorporated into perioperative risk evaluation, including those without CVA specialisation. However, use remains focused on conventional functional metrics, with limited knowledge of advanced CMR markers. Further research linking CMR parameters to perioperative outcomes, alongside targeted education initiatives, is needed to enable evidence-based implementation in anaesthetic practice.
Background: Prolonged hospital length of stay (LOS) after major upper gastrointestinal (GI) cancer surgery is associated with increased morbidity, mortality, and healthcare costs. Perioperative anaemia is common in this population. This study examined whether reduced haemoglobin (Hb) is independently associated with prolonged LOS after elective upper GI cancer surgery. Methods: We conducted a retrospective observational cohort study of patients undergoing elective upper GI cancer surgery at a tertiary hospital in Western Australia. Pre-, intra-, and postoperative data were obtained from a prospective institutional database. Patients were dichotomised into expected-LOS and prolonged-LOS groups based on the procedure-specific median LOS. Multivariable logistic regression was used to identify factors independently associated with prolonged LOS. Results: A total of 111 patients were included; 26 (23.4%) had prolonged LOS. These patients had lower Hb intraoperatively (106.5±17.9 vs 115.8±17.0 g L−1; P=0.021), on postoperative day 1 (100.1±17.3 vs 111.7±15.7 g L−1; P=0.002), and at first-week nadir (89.3±17.0 vs 104.9±16.6 g L−1; P<0.001). Reoperation (34.6% vs 7.1%; P=0.001) and unplanned ICU admission (15.4% vs 2.4%; P=0.023) were more frequent. After adjustment for these factors, a lower postoperative Hb concentration remained independently associated with a prolonged LOS. The first-week Hb nadir showed the strongest association (odds ratio 0.95 per g L−1; 95% confidence interval 0.92–0.98; P=0.002). Conclusions: Postoperative Hb decline is independently associated with prolonged LOS after elective upper GI cancer surgery. These findings support prospective evaluation of patient blood management strategies in this population.
Background:Patients' experiences of postoperative recovery provide insights beyond traditional outcomes. Postoperative complications impair recovery, prolong hospital stay, and affect well-being. Long-term data on recovery patterns, particularly regarding complications, are scarce but essential for guiding perioperative care. Methods:A pre-planned nested cohort study within the Myocardial Injury in Non-Cardiac Surgery in Sweden study was conducted at two Swedish hospitals; 124 adult patients undergoing major noncardiac surgery were followed for up to 1 yr. Lack of recovery was defined as a ≥6-point decrease in Quality of Recovery-15 (QoR-15) score from preoperative baseline. We assessed the incidence and risk factors, described the course of recovery, and examined the association between early lack of recovery and days alive and out of hospital (DAOH) at 30 days after surgery. Results:Lack of recovery was reported by 58%, 46%, and 24% of patients at 7-10 days, 30 days, and 1 yr, respectively. Complications occurred in 49% and were associated with a two-fold increase in the odds of lack of recovery at 30 days (adjusted odds ratio 2.60 [1.18-5.73]; P=0.018), independent of age, ASA physical classification score, and sex. Patients with complications reported lower QoR-15 scores and a slower recovery over time. Early lack of recovery was associated with 3.7 fewer days alive and out of hospital (mean difference -3.69 [-6.54 to -0.83]; P=0.012). Conclusions:Half of the study group reported a lack of recovery at 1 week, with persistence at 1 month. Complications were common and strongly associated with lack of recovery. Although recovery is slower in patients with complications, most regain or exceed baseline levels by 1 year. Early lack of recovery was linked to reduced days alive and out of hospital.
Background:Physiotherapy management of postoperative hypoxaemia is understudied. This trial aimed to assess the feasibility of a trial of physiotherapist-led noninvasive ventilation (NIV) in adults with hypoxaemia following major abdominal surgery. Methods:This prospective, single-centre, parallel-group, assessor-blinded, feasibility pilot trial with concealed allocation and intention-to-treat analysis randomised adults with hypoxaemia (oxyhaemoglobin saturations <90% on room air) within 72 h of major abdominal surgery to either usual care physiotherapy (education, early mobilisation, and deep breathing and coughing exercises), or usual care plus four 30-min sessions of physiotherapist-led NIV. The primary outcome was feasibility, including patient recruitment rates, NIV treatment adherence, and acceptability to patients. Exploratory outcomes included postoperative pulmonary complications (PPCs). Results:From 50 participants, 49 were analysed. Mean age (standard deviation) was 62 (10) yr and 51% were male. Over 30 weeks, the recruitment rate was 1.7 participants per week (95% confidence interval [CI], 0.7-3.4). Mean total NIV delivered was 78 min (95% CI, 55-100) of the protocolised 120 min. There were no serious adverse events. NIV was acceptable to 91% of participants (20/22; 95% CI, 72%-97%). The PPC incidence on trial enrolment ranged from 6% (3/49; 95% CI, 2%-17%) to 47% (23/49; 95% CI, 34%-61%) depending on the measurement tool used. Conclusions:Recruitment to this trial of physiotherapist-led NIV in patients with postoperative hypoxaemia was feasible. NIV was rated acceptable by most participants, and NIV adherence similar to that of previous trials. This study provides valuable insights for the design and conduct of future physiotherapy postoperative treatment studies. Clinical trial registration:ACTRN12622000839707. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382199&isReview=tru.
Background:Myocardial injury after noncardiac surgery (MINS) is associated with poor outcomes. Current prediction models have limitations and rarely incorporate postoperative hypotension. Our primary objective was to develop and validate a prediction model incorporating postoperative hypotension to predict subsequent postoperative high-sensitivity cardiac troponin T concentrations and MINS. Methods:We conducted a single-centre retrospective cohort study of patients aged ≥45 yr who underwent inpatient noncardiac surgery between 2020 and 2021 at St. Paul's Hospital, Canada. We excluded patients with missing vital signs or postoperative troponin concentrations, those who underwent repeat surgery <72 h after surgery, and those who were readmitted <72h after surgery. We developed multivariable linear mixed-effects models using percentage of time with postoperative hypotension (mean arterial pressure <75 mm Hg) on postoperative days (PODs) 0-2, age, sex, emergency surgery, and revised cardiac risk index to predict maximum troponin concentration on PODs 1-3 (primary model) and MINS (secondary model). Internal validation was performed using repeated patient-based five-fold cross-validation with 100 repetitions, using the root mean square error (RMSE), marginal R-squared (R2), and conditional R2 as metrics. Results:We included 846 patients (mean age 72 yr [standard deviation 11]; 57.4% male). Notably, 35% of patients (299 of 846) developed MINS between PODs 0 and 3. The primary linear mixed-effects model for log-transformed troponin showed a conditional R2 of 0.94, a marginal R2 of 0.20, and a cross-validated RMSE of 0.90 during internal validation. The internally validated MINS model area under the receiver operating characteristic curve was 0.69 (95% CI 0.63-0.75). The inclusion of intraoperative hypotension did not improve the prediction of troponin or MINS. Conclusions:A model including postoperative hypotension to predict postoperative troponin concentrations fits our data well, but did not show sufficient accuracy and is not ready for clinical practice. Better-quality data and additional clinical variables may enhance model development.Trial registration. Clinicaltrials.gov NCT05188001, registered 7 January 2022.
Background:Delirium is common among ICU patients and has been shown to be consistently associated with worse outcomes. Distinct outcomes among biological sexes in ICUs are being increasingly recognised; however, their role in the risk of delirium remains poorly characterised. Methods:This retrospective cohort study included adult patients admitted to ICUs at a tertiary-level academic medical centre from 2011 to 2024. The primary outcome was the incidence of delirium, measured using the Confusion Assessment Method for the ICU assessment tool as part of routine clinical care. Multivariable logistic regression analyses were used to characterise the association between biological sex and ICU delirium. Incidence of delirium between differing age groups and ICU admission types was also evaluated. Results:Of the 38 192 patients included, 56.1% (21 541) were male. In total, 46% (17 447) of patients experienced delirium during their ICU stay. Compared with female patients, male patients had a lower incidence of ICU delirium (adjusted odds ratio [aOR], 0.88; 95% confidence interval [CI], 0.83-0.93; P<0.001). Stratified by admission type, male patients, both <60 yr and 60 yr and above, admitted to medical ICUs had a lower risk of developing delirium compared with female patients (aOR, 0.82; 95% CI, 0.72-0.93; P=0.002; aOR, 0.89; 95% CI, 0.83-0.97; P=0.008, respectively), whereas this association was not significant among patients admitted to surgical ICUs, regardless of age group. Conclusions:Male patients had a lower incidence of ICU delirium. This association was most notable among patients admitted to medical ICUs. Assessment for delirium risk may include consideration of biological sex.
Goyal and colleagues share a large United States health system's experience of 9431 cases of real-world remimazolam use, offering insight into current practice patterns, recovery times, and accurate adverse event rates. The authors report rapid recovery after remimazolam, including shorter time to post-anaesthesia care unit discharge readiness and faster return to baseline on the Richmond Agitation-Sedation Scale following flumazenil administration, with a critical event rate of 0.7%. Interesting practice patterns were observed, including frequent co-administration with other anaesthetics rather than as a sole agent. Although only licensed for procedural sedation in the United States, the authors reported extensive use of remimazolam to induce anaesthesia, especially for patients with an American Society of Anesthesiologists physical status of 3-5. This editorial highlights the disconnect between the development of remimazolam and its practical clinical use, as well as the work still needed to clarify the agent's optimal role.
Moral injury, and stakes-dependent invisibility commonly arise from system issues and can lead to profound emotional distress, including feelings of shame and betrayal, but both are often disregarded by institutions. Stakes-dependent invisibility highlights the lack of power, the lack of perceived recognition of one’s contribution, and the lack of a voice, resulting in the failure to meet the individual’s needs. The mechanism of harm behind moral injury, however, is distinctively different: moral injury goes much deeper, focusing on the internal psychological and ethical damage caused by powerlessness or by actions taken or experienced, which are in direct conflict with the person’s own moral compass, violating their own conscience.
Background: Chronic post-surgical pain (CPSP) is a common long-term complication with multifactorial contributors, and improved risk stratification remains a clinical priority. This study aimed to identify factors associated with CPSP and related outcomes and to explore hypothesised multivariable pathways using a hybrid analytical approach. Methods: We performed a secondary observational analysis of 2999 participants from the Evaluation of Nitrous Oxide in the Gas Mixture for Anaesthesia (ENIGMA)-II CPSP substudy with 12-month postoperative assessment. Grouped lasso (GLASSO) was used for penalised feature selection across prespecified predictor groups, and partial least squares structural equation modelling (PLS-SEM) was applied within a theory-informed framework to explore associations among measured domains and outcomes. Analyses were exploratory and did not establish causal effects. Results: GLASSO models showed moderate discrimination/explanatory power (CPSP area under the curve 0.69, 95% confidence interval 0.64-0.74; EQ-5D R2=0.34; pain severity R2=0.29; pain interference R2=0.24). In PLS-SEM for CPSP, presurgical pain showed the strongest association (B=0.348), with smaller associations for demographics (B=0.169) and surgical aspects (B=0.091) and lifestyle patterns showed a small inverse association (B=-0.051). For EQ-5D, lifestyle was negatively associated (B=-0.248), and NSAID-related treatment patterns showed a small association (B=0.079). No clear associations were observed between dexamethasone or NSAID treatment patterns and CPSP. Conclusions: A GLASSO-PLS-SEM workflow provided an exploratory approach to identifying key features and mapping hypothesised multivariable associations in CPSP-related outcomes. External validation and richer psychosocial/structural measures are needed before clinical translation. Trial registration: ClinicalTrials.gov NCT00430989.
Background:Frozen plasma (FP) is the standard haemostatic therapy after cardiopulmonary bypass, but recent trials indicate that FP is inferior to four-factor prothrombin complex concentrate (PCC). Citrate content may contribute to this difference. We compared estimated citrate exposure between patients receiving FP and those receiving PCC and explored its association with postoperative bleeding. Methods:This post hoc analysis of the FARES-II randomised trial (30 November 2022 to 28 May 2024; 12 North American centres; 420 adults; 207 FP, 213 PCC) calculated estimated citrate load from all transfused products using published citrate-content data. The primary outcome was per-patient cumulative estimated citrate load at 12 and 24 h post-investigational medicinal product. Secondary outcomes were the hourly trajectory of group-total citrate delivery and its association with 12-h chest tube drainage by quartile. Results:In the FP group, total estimated citrate exposure was substantially higher, and the median per-patient estimated citrate load was approximately six-fold greater at 12-24 h. Administration of citrate-containing products continued through 8 h in patients receiving FP but was largely confined to the first 2 h in patients receiving PCC. Across all quartiles of estimated 12-h citrate load, patients treated with FP had higher estimated citrate exposure and chest tube drainage; patients treated with PCC in the highest quartile exhibited drainage volumes similar to those of patients treated with FP in the third quartile. Conclusions:This exploratory, hypothesis-generating analysis demonstrated markedly higher estimated citrate exposure with FP than PCC. Although causality cannot be established without direct citrate measurement, FP was associated with higher estimated citrate load and more variable chest tube drainage. Factor concentrates may reduce this burden, warranting further mechanistic investigation.ClinicalTrials.gov identifier: NCT05523297; https://clinicaltrials.gov/study/NCT05523297?term=NCT05523297&rank=1.
Background The primary treatment modality for colorectal cancer is surgery. Prehabilitation is advocated to mitigate risk and reduce complications, with benefits likely to be greatest in the least physically fit patients. There is an intersection between physical inactivity, socioeconomic deprivation and multimorbidity that increases surgical risk; however, these patients are under-represented in trials. This review aimed to scope the available evidence for prehabilitation in the least fit patients undergoing colorectal cancer surgery. Methods A scoping review was conducted using Joanna Briggs Institute methodology and reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. MEDLINE, EMBASE and CINAHL were searched for studies investigating exercise prehabilitation in adults undergoing colorectal cancer surgery. Studies were screened for low physical fitness using pre-determined criteria. Data charting included reporting of intervention characteristics (Template for Intervention Description and Replication [TIDieR] framework), adherence, outcomes, socioeconomic status and multimorbidity. Results Twelve studies investigating 408 patients were identified. Despite a relatively uniform high-risk patient profile, prehabilitation interventions were heterogeneous, encompassing six distinct approaches with limited tailoring to low baseline fitness. Trials reporting improved clinical outcomes demonstrated high adherence, but this was inconsistently defined and reported. Behaviour change strategies were not incorporated. No study reported socioeconomic status, and multimorbidity reporting was variable. Conclusions Prehabilitation research in patients with colorectal cancer and low physical fitness has focused on physiological risk. Wider socioeconomic and behavioural determinants of participation require consideration. A conceptual framework is proposed to guide future practice. This emphasises comprehensive risk screening, flexible and patient-centred interventions, and strategies to optimise adherence in those high-risk patients who stand to benefit the most.
Background Traditional randomized control trials underpin evidence generation in anaesthesia and perioperative medicine, but are often poorly suited to evaluating multiple, evolving clinical questions. Platform trials encorporate a trial design that evaluates multiple interventions within one or more domains, is governed centrally using a master or core protocol, and has the capacity to add new research questions through the addition of new treatments and/or subgroup. Platform trials offer a flexible alternative, enabling the concurrent and sequential evaluation of multiple interventions and more efficient identification of effective or harmful treatments. Methods We conducted a scoping review using the Joanna Briggs Institute methodology, reported in accordance with PRISMA-ScR. Searches of bibliographic databases, grey literature and clinical trial registries (Ovid MEDLINE, Ovid Embase, Scopus, CINAHL Complete, Web of Science and the Cochrane Library) were undertaken. Records meeting an a priori definition of platform trials in anaesthesia or perioperative medicine were included. Trial design and methodological features were extracted and synthesised descriptively. Results Among 32 062 records identified, nine platform trials met eligibility criteria. Most were registered (8/9) and university-sponsored, with nearly half in the planning phase. All trials were multicentre, predominantly conducted in high-income countries and 44% involved international collaboration. Adult surgical populations were most commonly studied, with surgical site infection prevention being the leading perioperative focus. Across the nine platform trials, 24 interventions were evaluated, predominantly surgical (58.3%), followed by anaesthetic (12.5%). Adaptive features were universal, and Bayesian statistical methods predominated. Conclusions Platform trials remain uncommon and methodologically diverse in anaesthesia and perioperative medicine, reflecting early-stage adoption within an evolving field. Greater consensus regarding nomenclature, governance, and methodological standards, alongside expansion into anaesthesia-specific domains, is needed to realise their efficiency and ethical advantages.
