Importance:Explanatory trials suggest that prehabilitation has efficacy in improving surgical outcomes. The effectiveness of offering home-based prehabilitation across multiple centers and for older adults with frailty remains unknown. Objective:To evaluate the effectiveness of offering coach-supported, home-based prehabilitation to older surgical patients with frailty. Design, Setting, and Participants:This study is a pragmatic, parallel-arm, multicenter randomized clinical trial with embedded qualitative assessment. Clinicians and assessors were fully blinded; participants were partially blinded in that the control arm received publicly available activity and nutritional guidelines. From March 2, 2020, to February 8, 2024, participants aged 60 years and older with frailty (Clinical Frailty Scale score ≥4) scheduled for elective, inpatient noncardiac surgery were recruited from surgeon's offices at 13 centers in Canada. Data analysis was completed from October 3, 2024, to December 5, 2024. Intervention:Assignment to a home-based, multimodal program of exercise and personalized nutritional recommendations, remotely supported by coaches using a theory-based approach to enhance adherence. Main Outcomes and Measures:The coprimary outcomes were patient-reported disability 30 days after surgery using the World Health Organization Disability Assessment Schedule 2.0 and the incidence of any postoperative complication during the surgical hospitalization. Barriers to adherence were identified using the Theoretical Domains Framework. Secondary outcomes were intervention-attributable safety events, health-related quality of life, survival, falls, complication severity, activities of daily living, length of stay, discharge disposition, lower limb function, and readmission. Analysis was by mixed-effects regression, adjusting for stratification and prespecified prognostic factors. Results:Of 992 eligible participants, 847 (85.4%) were randomized (423 to prehabilitation and 424 to usual care), and 705 participants had their planned surgery (353 in the prehabilitation group and 352 in the usual care group). A total of 452 participants (53.4%) were female, and mean (SD) participant age was 71.7 (7.1) years. A median (IQR) of 4 weeks (3-7) of prehabilitation enrollment was achieved. Preoperative safety outcomes did not differ between groups. Participants assigned to prehabilitation reported a mean (SD) postoperative disability score of 23.5 (21.8) compared to 24.7 (23.8) for usual care (adjusted mean difference, -1.4; 97.5% CI, -4.9 to 2.0; P = .36). Complications occurred in 177 participants (50.1%) assigned to prehabilitation and 168 control participants (47.7%) (adjusted odds ratio, 1.05; 97.5% CI, 0.73-1.49; P = .78). Participants completing more than 75% of prescribed exercises reported significantly lower disability scores with prehabilitation (mean difference, -4.9; 97.5% CI, -9.8 to -0.01; P = .02), but there was no significant difference in complications (odds ratio, 1.06; 97.5% CI, 0.67-1.67; P = .79). Primary barriers to adherence were competing priorities and motivation. Conclusions and Relevance:In this randomized clinical trial among older adults with frailty scheduled for surgery, assignment to home-based prehabilitation before surgery did not improve postoperative disability scores or reduce complications. Trial Registration:ClinicalTrials.gov Identifier: NCT04221295.
Systematic reviews with network meta-analysis frequently evaluate complex interventions combining multiple healthcare interventions (known as components). Components may act separately of each other or in conjunction with other components, synergistically or antagonistically. Component effect estimation is crucial to produce relevant and clinically meaningful evidence. However, standard network meta-analysis cannot quantify individual component effects of complex interventions. This article presents methods for modelling complex interventions and highlights the advantages and limitations of component network meta-analysis (CNMA). CNMA enables the estimation of individual component effects, whether additive or interactive. Interaction CNMA can be considered an extension of the additive CNMA model that allows component effects to vary in the presence of each other. This article presents practical guidance on how to carry out these analyses via empirical examples, which showcase both the strengths and limitations of CNMA. Implementing CNMA models is complex and requires the skills of a multidisciplinary team including clinicians, methodologists, and statisticians.
Frailty is increasingly recognised as a prognostic marker in cardiovascular disease, but its role in cardiogenic shock is less defined. In this retrospective cohort study across 188 intensive care units (ICUs), we analysed data from the Australia and New Zealand Intensive Care Society Adult Patient Database on adults (≥ 16 years) with admitted with cardiogenic shock between 2017–2023, and a documented Clinical Frailty Scale (CFS). The primary outcome was death at up to four years using an adjusted Cox proportional hazards model, which we also assessed using a time-varying model. We conducted subgroup analyses based on age, sex, aetiology of cardiogenic shock, and a landmark survival analysis at ICU discharge. We included 71,359 patients (median age 68.6 years, 70.0
BACKGROUND:Long-term care (LTC) residents are frequently transferred to emergency departments (ED), which may increase the risk of impairment. OBJECTIVE:To examine associations between all-cause ED transfers and development of new permanent severe physical and cognitive impairments, and death. SETTING AND PARTICIPANT:Adults ≥65 with incident admission to LTC homes in Ontario, Canada between 2013 and 2018. METHODS:We conducted a retrospective cohort study. We examined rates of (i) severe physical impairment, (ii) severe cognitive impairment and (iii) all-cause mortality after transfer to ED. We used marginal structural models to estimate the combined effect of acute illness and ED transfer. We used an instrumental variable (IV) analysis to isolate the effect of transfer, adjusting for acute illness. RESULTS:Of 120,238 residents, 78,546 (65.3%) residents had at least one transfer to the hospital. The mean (SD) age was 84.6 (7.9) years, 67.2% were female. The incidence rate ratios were 3.0 (95% CI, 2.9-3.1) for new physical impairment, 2.2 (95% CI, 2.1-2.3) for cognitive impairment and 5.8 (95% CI, 5.7-5.9) for mortality, comparing transferred to never-transferred residents. In IV analysis, transfers were not associated with permanent physical or cognitive impairment (hazard ratio [HR] (95% CI) [HR1.20] (0.92-1.55); [HR0.86] (0.69-1.06), but were associated with decreased mortality [HR0.57] (CI 0.50-0.63). CONCLUSION:In unadjusted analyses, residents transferred to ED had a higher incidence of permanent physical impairment, cognitive impairment and mortality. After adjusting for acute illness, transfer decisions were not associated with changes in the risk of severe impairment and were associated with reduced mortality.
BACKGROUND:Although selective cyclooxygenase-2 (COX‑2) inhibitors are commonly used in perioperative pain management, it is uncertain whether these anti-inflammatory agents meaningfully improve postoperative recovery, including the impact of pain on daily functioning. METHODS:This study systematically searched MEDLINE, Embase, and Cochrane CENTRAL for randomized controlled trials comparing systemic perioperative selective COX‑2 inhibitors with placebo, opioids, or usual care in adults. The primary outcome was postoperative acute pain, assessed using any validated multidimensional instrument evaluating pain‑related interference with daily living (e.g., Brief Pain Inventory; 0 to 10 scale, minimal clinically important difference = 1.0) within 1 month after surgery. Secondary outcomes included chronic pain, quality of recovery, and adverse events. Two reviewers independently performed study selection, data abstraction, risk of bias and certainty of evidence assessments. Clinical significance was assessed by estimating the difference between groups in the proportion of participants achieving the minimal important difference. RESULTS:A total of 9,071 citations were screened, and 38 randomized controlled trials (5,424 participants) met eligibility criteria. Selective COX-2 inhibitors were associated with a reduction in acute pain‑related interference (Brief Pain Inventory mean difference [MD], -1.1; 95% CI, -1.4 to -0.8; n = 7; moderate certainty) and in chronic pain incidence (odds ratio, 0.44; 95% CI, 0.21 to 0.93; n = 5; low certainty), but no significant effect was found on chronic pain intensity (MD, -1.0; 95% CI, -2.7 to 0.7; n = 1; very low certainty). The modeled risk difference for achieving a clinically important analgesic effect showed a substantial benefit of COX-2 inhibitors for acute pain. Quality of recovery improved with the intervention (Quality of Recovery-9 [0 to 18 scale] MD, 0.84; 95% CI, 0.33 to 1.35; n = 7; low certainty). Intraoperative blood loss was lower (MD, -22 ml; 95% CI, -40 to -4; n = 3; low certainty), and no differences were observed in other adverse events (i.e., acute renal failure, gastrointestinal bleeding, impaired bone healing, myocardial infarction, stroke, and death). CONCLUSIONS:Perioperative selective COX‑2 inhibitors likely provide a clinically meaningful reduction in acute pain-related interference with daily function and may improve chronic pain and quality of recovery.
BACKGROUND:Frailty is prevalent among older adults and associated with increased postoperative morbidity and death. Guidelines recommend consideration of frailty to inform preoperative cardiac risk stratification. However, its incremental prognostic value beyond established tools including clinical indices, functional capacity, and biomarkers is uncertain. METHODS:We conducted a secondary analysis of a multicenter prospective cohort study involving older adults (aged ≥65 years) undergoing major elective noncardiac surgery. Frailty was assessed using the Clinical Frailty Scale. The primary outcome was 30-day major adverse cardiac events, defined as myocardial infarction, nonfatal cardiac arrest, or death. Multivariable logistic regression evaluated the association between frailty (Clinical Frailty Scale ≥4) and major adverse cardiac events, adjusting for age, sex, Revised Cardiac Risk Index, Duke Activity Status Index, and natriuretic peptide concentration. Incremental prognostic value was assessed using the likelihood ratio test, concordance index, fraction of new predictive information, and decision curves. RESULTS:Among 1939 participants (median age, 72 years; 42% women), 43% had frailty, and 4.9% experienced 30-day major adverse cardiac events. The Duke Activity Status Index and the Clinical Frailty Scale were strongly correlated (R=-0.64). Frailty was associated with major adverse cardiac events after adjustment for age, sex, and Revised Cardiac Risk Index (odds ratio, 1.62 [95% CI, 1.05-2.51]) but not after further adjustment for Duke Activity Status Index or natriuretic peptide concentrations. Frailty improved prediction beyond clinical factors alone but not when functional capacity or biomarkers were included. CONCLUSIONS:Frailty was associated with increased cardiac risk and improved prediction beyond clinical factors, but its incremental prognostic value diminished when functional capacity or biomarkers were available, supporting its selective use when these measures are unavailable.
BACKGROUND:Cataract surgery is usually performed with topical anesthesia and sedation, which may be provided through a number of different care models with or without involvement of a physician anesthesiologist. We sought to describe anesthesiology care for cataract surgery in Ontario, Canada, and examine the association between the model of anesthesiology care and health service and perioperative outcomes after cataract surgery. METHODS:We conducted a population-based study of patients who underwent cataract surgery in Ontario using linked health administrative data between 2012 and 2021. The primary outcome was a composite of death, acute hospital admission, or emergency department visit up to 7 days postoperatively. We also collected data on health system costs and operative complications (from physician billing codes). We used multilevel, multivariable regression to estimate adjusted associations between anesthesiology care - fee-for-service anesthesiology care (FFS), care from an anesthesiology care team (ACT), or no physician anesthesiologist care - and outcomes. RESULTS:Of 1 271 251 patients who underwent cataract surgery, 670 754 (52.8%) received FFS care, 256 760 (20.2%) received ACT care, and 343 737 (27.0%) had no physician anesthesiologist care. Adjusted analyses estimated slightly lower odds of the primary composite outcome for patients who received FFS care (n = 8682, 1.3%; adjusted odds ratio [OR] 0.93, 95% confidence interval [CI] 0.88 to 0.99) or ACT care (n = 3034, 1.2%; adjusted OR 0.83, 95% CI 0.76 to 0.89) compared with those with no physician anesthesiologist care (n = 5056, 1.5%). Odds of operative complications were lower and overall costs were higher with any type of physician-provided anesthesiology care. Primary results differed by whether care was provided in a teaching or nonteaching hospital. INTERPRETATION:Care provided or overseen by a physician anesthesiologist was associated with significantly lower odds of an emergency department visit, hospital admission, or death; however, effect sizes were small and of limited clinical importance, and costs were higher. Given these findings, the use of physician anesthesiology care for routine cataract surgery should be reconsidered. PROTOCOL REGISTRATION:Open Science Framework identifier https://osf.io/9y3mt/overview.
Background:Guidelines recommend structured self-reported functional capacity assessment for preoperative cardiac risk stratification, including the Duke Activity Status Index (DASI). However, evidence supporting its incremental prognostic value beyond established risk factors remains limited. We evaluated the prognostic performance of the DASI using pooled data from two prospective cohorts. Methods:We conducted a pooled cohort analysis of adults undergoing elective major non-cardiac surgery enrolled in the Measurement of Exercise Tolerance before Surgery (METS) and Functional Improvement Trajectories After Surgery (FIT After Surgery) studies, including data collected between March 2013 and April 2023. Before surgery, participants completed the Duke Activity Status Index (DASI), a structured 12-item questionnaire based on daily physical activities, and underwent routine preoperative biomarker measurement. The primary outcome was 30-day major cardiac complications (myocardial infarction or non-fatal cardiac arrest) or death. The secondary outcome was all-cause major complications. Hierarchical logistic regression assessed the incremental prognostic value of the DASI beyond age, Revised Cardiac Risk Index (RCRI), and natriuretic peptide concentration. Prognostic performance was evaluated using the likelihood ratio test (LRT), fraction of new predictive information, net reclassification improvement, c-index, calibration plots, and decision curve analysis. Findings:Among 3485 patients, 3.6% (n = 126) experienced the primary outcome and 19% (n = 647) experienced the secondary outcome. The DASI provided prognostic information beyond age, RCRI, and natriuretic peptide concentration for the primary outcome (LRT p = 0.009), and beyond age, sex, and surgery type for the secondary outcome (LRT p < 0.001). Inclusion of the DASI improved prognostic performance across multiple metrics, but overall discrimination of the final models remained modest (c-index 0.70-0.71), with limited net clinical benefit. Predicted risk associated with a given DASI score varied substantially by age, RCRI, and natriuretic peptide concentration, supporting interpretation of the DASI as a continuous prognostic marker rather than a dichotomous screening test. Interpretation:The DASI provides incremental prognostic information for preoperative cardiac risk assessment beyond guideline-recommended predictors. Its prognostic implications are modest, context-dependent, and best interpreted as a continuous prognostic marker alongside established risk factors, rather than as a stand-alone threshold-based tool. Funding:Canadian Institutes of Health Research; PSI Foundation; and the Elizabeth A. and Richard J. Currie, O.C. Chair in Translational Anesthesia Research at St. Michael's Hospital and the University of Toronto; The Ottawa Hospital Academic Medical Organization Innovation Fund; Heart and Stroke Foundation of Canada; Ontario Ministry of Health and Long-Term Care; Ontario Ministry of Research, Innovation and Science; UK National Institute of Academic Anaesthesia; UK Clinical Research Collaboration; Australian and New Zealand College of Anaesthetists; Monash University.
Importance:The number of older adults living with frailty who undergo surgery is rapidly increasing worldwide. Life-space mobility (LSM) can capture physical and social dimensions of recovery and has been linked to functional decline and reduced quality of life. Objective:To examine postoperative recovery using LSM among older adults living with frailty and to identify factors associated with restricted mobility and readmission. Design, Setting, and Participants:This cohort study within the larger Functional Improvement Trajectories After Surgery study used a convergent mixed-methods exploratory design. Seventeen hospitals across Canada included older adults aged 65 years or older with a clinical frailty score (CFS) of 3 or more who underwent major elective noncardiac surgery from March 2021 to June 2023. Data were analyzed from September to October 2025. Exposure:Elective noncardiac surgery among older adults. Main Outcomes and Measures:LSM (range 0-120, with higher scores indicating more mobility) was measured at 1 to 2 months and 6 months postoperatively, with retrospective presurgery LSM captured at 1 to 2 months. Multivariable linear mixed-effects models and multivariable mixed-effects logistic regression were used to identify factors associated with LSM trajectories, restricted mobility (ie, LSM < 60), and hospital readmission. Results:This study included 204 participants (mean [SD] age, 72.8 [5.6] years; 108 males [53%]). The mean (SD) LSM was 65.1 (26.7) presurgery, 56.6 (26.7) at 2 months postsurgery, and 64.9 (25.9) at 6 months postsurgery. Eighty participants (39.2%) had restricted mobility presurgery, 114 (56.4%) at 2 months postsurgery, and 84 (41.2%) at 6 months postsurgery. Restricted mobility was associated with being a woman (odds ratio [OR], 4.72; 95% CI, 2.27-9.84), greater frailty (OR, 10.42; 95% CI, 3.56-30.49), and concurrent need for support from formal or informal caregivers (OR, 5.43; 95% CI, 2.72-10.86). Elevated-risk surgery was associated with hospital readmission at 6 months (OR, 3.18; 95% CI, 1.48-7.25). Conclusions and Relevance:In this nested cohort study, mean LSM recovered by 6 months postsurgery, but 41% of older adults still had restricted mobility. Being a woman, having greater frailty, and needing support from caregivers were associated with poor recovery. Integrating life-space assessments into individualized perioperative care planning may enhance evaluation of functional recovery, inform shared decision-making, and guide support strategies.
Importance:An increasing number of older adults living with frailty are undergoing surgery, yet scarce data on postoperative functional recovery, care needs after surgery, and extent of caregiver supports exist. Objective:To characterize older adults' and caregivers' recovery experiences in the first 6 months after surgery. Design, Setting, and Participants:This mixed-methods, multicenter, prospective nested cohort study included 17 hospitals in Canada. Participants included adults aged 65 years or older with a Clinical Frailty Scale score of 4 or more, who were recovering after major elective noncardiac surgery between March 16, 2021, and June 13, 2023, and their caregivers. Main Outcomes and Measures:Surveys included functional status via basic and instrumental activities of daily living, care needs, and care received or provided. A subset of patients and caregivers were invited to participate in semistructured interviews about their experiences and were analyzed using interpretive descriptive qualitative analysis. Results:There were 289 individuals, including 204 older adults (mean [SD] age, 72.8 [5.6] years; 108 males [52.9%]) and 85 caregivers (mean [SD] age, 68.2 [12.2] years; 50 females [59.5%]), who participated in surveys, and 63 individuals (43 older adults and 20 caregivers) who participated in interviews. Older adults had a median (range) Clinical Frailty Score of 4 (3-6), indicating mild frailty, and 190 (93.1%) had 1 or more chronic diseases. Caregivers had a median (range) of 2 (0-8) chronic diseases, and 69 (82%) were spouses. Two months postoperatively, 129 of 203 older adults (64%) had more than 1 instrumental activities of daily living impairment, decreasing to 84 of 198 (42%) at 6 months after surgery; 68 of 203 (33%) had more than 1 activities of daily living impairment 2 months postoperatively, and this decreased to 38 of 198 (19%) at 6 months after surgery. Themes related to the recovery experiences were: (1) inadequate patient and caregiver education, preparation for surgery, and discharge; (2) the association of reduced independence with patient and caregivers; (3) the association of surgery with mental health; and (4) postoperative support from the health care team. All participants indicated that they wanted to be better prepared for surgery and discharge. Conclusion and Relevance:In this mixed-methods cohort study, functional recovery in the first 6 months after noncardiac major elective surgery was associated with daily living impairment for older adults and their caregivers. Targeted interventions including preoperative education, caregiver-inclusive discharge planning (eg, wound-care teaching, how to recognize complications and what to do for support, and more rehabilitation), and early follow-up after discharge may optimize recovery experiences.
Background:A pragmatic, multicentre randomised trial of virtually supported, home-based prehabilitation is required to evaluate effectiveness in generalisable settings; however, feasibility is unknown. Methods:This was a pragmatic, parallel-arm, multicentre internal pilot randomised controlled trial. Adults aged 18 years or older preparing for planned, inpatient non-cardiac, non-orthopaedic surgery were recruited from surgeons' offices at five Canadian centres (30 January to 11 July 2024). Participants were randomised to a virtually supported home-based prehabilitation programme (exercise, protein supplementation, psychosocial support) delivered by trained coaches using a theory-based approach, or to usual care. Feasibility outcomes were recruitment (target >6 participants/centre/month), adherence (>75%), and outcome completeness (>90%). Barriers and facilitators were assessed using a validated Theoretical Domains Framework (TDF) survey. Cluster analyses explored patterns of TDF responses and associations with adherence. Results:We randomised 144/154 eligible participants (93.5%; recruitment rate: 8.4, standard deviation [sd] 4.4 participants/center/month). The mean participant age was 62 (sd 12, range 28-85). Trial-level median adherence was 95% (inter-quartile range 73-100), and 57 (78.5%) participants achieved >75% adherence. Patient-reported outcomes were complete for 137 (95.1%) participants at 30 days, 136 (94.4%) at 90 days, and 129 (89.5%) at 365 days after operation. Participants identified beliefs about consequences and capabilities, intentions, and social roles as facilitators. Environmental context and emotions were barriers. Participants' TDF response profiles clustered in three groups. Cluster membership was strongly associated with adherence (P<0.001) and explained 28% of observed variation in adherence to prehabilitation. Conclusions:A pragmatic, multicentre trial of virtually supported home-based multimodal prehabilitation is feasible. Findings support progression to a fully powered trial. Observed associations between perceived barriers, facilitators, and adherence should be validated. Trial registration:ClinicalTrials.gov NCT06042491.
BACKGROUND:Guidelines recommend routine preoperative frailty assessment; however, existing data suggest that adherence is low. The ability with which patients can evaluate their frailty before surgery is unknown. Our objective was to evaluate the agreement of patient self-reporting of frailty compared with trained assessors using the Clinical Frailty Scale (CFS). METHODS:This was a sub study of a multicentre prospective cohort study of people ≥65 yr of age having elective noncardiac surgery. Preoperatively, patients and trained assessors independently rated patient frailty using the CFS. Agreement between raters on the ordinal scale was estimated using weighted kappa. We evaluated agreement after dichotomising scores (CFS≥4) using Cohen's kappa. We also described the discriminative ability of self-reported and assessor-reported CFS scores in predicting the occurrence of death or new disability 90 days after surgery. RESULTS:There were 531 participants with both self-reported and assessor-reported CFS. Agreement was moderate (weighted kappa=0.58 [95% confidence interval, CI 0.53-0.63], Cohen's kappa=0.61 [95% CI 0.54-0.68]). Assessor-rated scores were systematically higher than self-rated scores by a mean of 0.45 points (95% CI 0.39-0.52; P<0.001). When predicting death or new disability, paired receiver operating characteristic curve analysis revealed no difference in discriminative capability of self-rated or assessor-rated CFS assessment (c-statistic difference 0.010 [95% CI -0.072 to 0.092; P=0.81]). CONCLUSIONS:Patients self-report their frailty status using the CFS with moderate agreement to a trained frailty assessor. Self-reported and assessor-rated scores had similar predictive capability for postoperative death or new disability.
QuestionCan home-based prehabilitation improve patient-centered outcomes after surgery for older adults living with frailty?FindingsIn this pragmatic randomized clinical trial that included 847 older adults living with frailty, assignment to home-based prehabilitation before surgery did not improve postoperative disability scores or reduce complications. However, participants completing more than 75% of prescribed exercises reported significantly lower disability scores with prehabilitation.MeaningAssignment to home-based prehabilitation with structured coaching did not improve patient-centered outcomes across all participants; given promising findings in adherent participants, intervention design and delivery require further optimization to overcome barriers to adherence. ImportanceExplanatory trials suggest that prehabilitation has efficacy in improving surgical outcomes. The effectiveness of offering home-based prehabilitation across multiple centers and for older adults with frailty remains unknown.ObjectiveTo evaluate the effectiveness of offering coach-supported, home-based prehabilitation to older surgical patients with frailty.Design, Setting, and ParticipantsThis study is a pragmatic, parallel-arm, multicenter randomized clinical trial with embedded qualitative assessment. Clinicians and assessors were fully blinded; participants were partially blinded in that the control arm received publicly available activity and nutritional guidelines. From March 2, 2020, to February 8, 2024, participants aged 60 years and older with frailty (Clinical Frailty Scale score >= 4) scheduled for elective, inpatient noncardiac surgery were recruited from surgeon's offices at 13 centers in Canada. Data analysis was completed from October 3, 2024, to December 5, 2024.InterventionAssignment to a home-based, multimodal program of exercise and personalized nutritional recommendations, remotely supported by coaches using a theory-based approach to enhance adherence.Main Outcomes and MeasuresThe coprimary outcomes were patient-reported disability 30 days after surgery using the World Health Organization Disability Assessment Schedule 2.0 and the incidence of any postoperative complication during the surgical hospitalization. Barriers to adherence were identified using the Theoretical Domains Framework. Secondary outcomes were intervention-attributable safety events, health-related quality of life, survival, falls, complication severity, activities of daily living, length of stay, discharge disposition, lower limb function, and readmission. Analysis was by mixed-effects regression, adjusting for stratification and prespecified prognostic factors.ResultsOf 992 eligible participants, 847 (85.4%) were randomized (423 to prehabilitation and 424 to usual care), and 705 participants had their planned surgery (353 in the prehabilitation group and 352 in the usual care group). A total of 452 participants (53.4%) were female, and mean (SD) participant age was 71.7 (7.1) years. A median (IQR) of 4 weeks (3-7) of prehabilitation enrollment was achieved. Preoperative safety outcomes did not differ between groups. Participants assigned to prehabilitation reported a mean (SD) postoperative disability score of 23.5 (21.8) compared to 24.7 (23.8) for usual care (adjusted mean difference, -1.4; 97.5% CI, -4.9 to 2.0; P = .36). Complications occurred in 177 participants (50.1%) assigned to prehabilitation and 168 control participants (47.7%) (adjusted odds ratio, 1.05; 97.5% CI, 0.73-1.49; P = .78). Participants completing more than 75% of prescribed exercises reported significantly lower disability scores with prehabilitation (mean difference, -4.9; 97.5% CI, -9.8 to -0.01; P = .02), but there was no significant difference in complications (odds ratio, 1.06; 97.5% CI, 0.67-1.67; P = .79). Primary barriers to adherence were competing priorities and motivation.Conclusions and RelevanceIn this randomized clinical trial among older adults with frailty scheduled for surgery, assignment to home-based prehabilitation before surgery did not improve postoperative disability scores or reduce complications.Trial RegistrationClinicalTrials.gov Identifier: NCT04221295 This multicenter randomized clinical trial evaluates the effectiveness of offering coach-supported, home-based prehabilitation to older patients with frailty scheduled for surgery.
BACKGROUND:Cognitive prehabilitation aims to increase preoperative cognitive reserve to improve neurocognitive outcomes. Structured synthesis is required to describe the design, feasibility, adherence and outcomes of cognitive prehabilitation trials to inform current practice and future research. METHODS:We conducted a scoping review using best practices. A protocol was registered, and a peer-reviewed search strategy was applied to MEDLINE, Embase, CINAHL, PsycINFO, Web of Science and Cochrane CENTRAL (inception to 04/2025). Duplicate, independent review identified studies that enrolled adults in randomised controlled trials of cognitive prehabilitation. Narrative synthesis described: 1) populations; 2) interventions; 3) adherence; 4) barriers; and 5) outcomes. RESULTS:Across eight included trials (n=833), mean age ranged from 56 to 73.2 yr; seven trials excluded participants with pre-existing cognitive impairment. Six trials evaluated home-based, computerised multidomain brain training; two involved supervised in-hospital sessions. Programme duration was 1-4 weeks; sessions lasted 15-60 min. Five trials reported low adherence (8.8%-40%); one achieved 68% adherence with supervision, whereas one in-hospital program achieved 94.1% adherence. Barriers included feeling overwhelmed, lacking technical support and time. Two trials with high adherence reported a significant reduction in delirium (Absolute Risk Reduction [ARR] 9.8%-15.9%) and postoperative neurocognitive disorders (ARR 20.2%-36.8%). CONCLUSIONS:Cognitive prehabilitation trials consistently evaluate multidomain, computerised brain training, and, with high adherence, efficacy is evident. Optimal duration and intensity must be established, and barriers related to support, time, and technology need be addressed before conducting evaluations in multicentre trials.
BACKGROUND:Extended-release opioids (EROs) are not recommended for acute postoperative pain, yet their prescribing persists. This study examined the incidence, predictors, and variation in ERO dispensing after total hip and knee arthroplasty. METHODS:This was a population-based cross-sectional study of adults undergoing primary total hip or knee arthroplasty between 2013 and 2022 using linked administrative databases in Ontario, Canada. The primary outcome was fulfillment of an ERO prescription within 7 days of discharge. Multilevel logistic regression estimated associations between patient, surgical, anesthetic, and hospital factors and filling an ERO prescription. Variation was quantified using variance partition coefficients (VPCs) and median odds ratios (MORs) with 95% CIs, based on random effects. RESULTS:Among 258,642 knee and hip arthroplasty procedures, 31,224 (12.1%) patients filled a new ERO prescription after discharge. Male sex (odds ratio [OR], 1.14; 95% CI, 1.09 to 1.19), preoperative opioid exposure (Opioid Naïve-Exposed-Tolerant score, 2; OR, 1.21; 95% CI, 1.15 to 1.27; Opioid Naïve-Exposed-Tolerant score, 3; OR, 1.38; 95% CI, 1.20 to 1.58), and American Society of Anesthesiologists status of III (OR, 1.07; 95% CI, 1.01 to 1.12) increased the odds of filling a new ERO prescription. Neuraxial anesthesia (OR, 0.79; 95% CI, 0.74 to 0.84), peripheral nerve block (OR, 0.84; 95% CI, 0.79 to 0.89), and acute pain service involvement (OR, 0.77; 95% CI, 0.70 to 0.85) were protective against filling a new ERO prescription. Substantial variation was found across hospitals (VPC, 46%; 95% CI, 0.4 to 0.54; and MOR, 9.3; 95% CI, 6.57 to 15.27) and surgeons (VPC, 26%; 95% CI, 0.24 to 0.26; and MOR, 5.3; 95% CI, 4.63 to 6.11), with minimal anesthetist-level variation (VPC, 1%; 95% CI, 0.010 to 0.011; and MOR, 1.4; 95% CI, 1.36 to 1.46). Patient-level factors explained a minority of variation. CONCLUSIONS:One in 10 patients fills an ERO prescription after total hip or knee arthroplasty, a practice with high variation that is predominantly driven by institutional and surgical practice patterns rather than patient factors. Future research should explore institutional stewardship, standardized discharge protocols, and multidisciplinary engagement to reduce unnecessary postoperative exposure to EROs.
BACKGROUND:Method comparison studies are conducted to examine the level of agreement between two instruments measuring physiological continuous parameters. The inclusion of repeated measurements in such studies poses additional challenges. The Bland & Altman limits of agreement (LOA) approach has been adapted to account for the correlation between repeated measurements and is widely used in method comparison studies. Alternate statistical methods are not always appropriate for the analysis of such data, and there is a paucity of evidence and guidelines pertaining to statistical methods that inform the analysis of method comparison studies that include repeated measurements. This scoping review aimed to identify methodological publications that propose statistical methods to inform the analysis of method comparison studies that include repeated measurements of continuous clinical data and that may be compared with the LOA method. METHODS:Six online databases were searched from inception to November 2022 using a peer-reviewed search strategy. Searching of grey literature and books, as well as backward citation searching were performed to identify additional sources of evidence. Screening and data abstraction were done by two independent reviewers. Results were synthesized narratively. RESULTS:Twenty-nine publications were included in this review. Thirty-two independent statistical methods were identified from the included publications, including variants of the LOA method. Four included publications compared findings from different versions of the LOA method. Four different approaches to handling repeated measurements in the context of method comparison studies were identified and were used to group findings from the included publications. Reported strengths and limitations of the LOA method were summarized. CONCLUSION:This scoping review provides a synthesis of existing statistical approaches to inform the analysis of method comparison studies with repeated measurements of clinical data, as well as how the various statistical methods perform when compared with various version of the LOA method. Based on the findings, it is generally advisable to consider using adjusted LOAs or modified mixed-effect LOAs in analyzing method comparison studies with repeated measurements. TRIAL REGISTRATION:The protocol was registered on Open Science Framework ( https://osf.io/4p8ut ).
BACKGROUND:Although polysomnography (PSG) is the diagnostic gold standard, PSG data on obstructive sleep apnea (OSA) presence and severity are rarely available at the population level. Health administrative databases offer broad coverage for OSA case ascertainment but require methods that address inherent misclassification. We utilized a previously validated probabilistic case ascertainment model of OSA to estimate population-level prevalence and correlates of OSA. METHODS:We conducted a population-based retrospective cohort study in Ontario, Canada. First, using a clinical cohort with PSG-confirmed OSA severity (measurement cohort; n = 18 581), we quantified misclassification in probabilistic OSA case definitions. We then applied the externally validated probability models to all adults 18 years and older in Ontario who underwent in-laboratory overnight PSG between 2010 and 2018 (provincial PSG cohort; n = 834 361). OSA prevalence and correlates were estimated using multiple probability thresholds and a threshold-free bootstrap imputation approach (BIA). RESULTS:Compared to the PSG-based gold standard, the BIA surrogate definition had the lowest average relative bias in OSA prevalence estimation (BIA: 5% versus >38% probability threshold: 11.4%). Using BIA, we estimate a 44.3% prevalence of moderate-severe OSA in the provincial PSG cohort, which in scenario-based projections yields a 3.4%-17.1% general population prevalence dependent on an assumed OSA underdiagnosis rate. OSA prevalence was higher in men, older ages, and previous comorbidity and was stable annually. CONCLUSION:Probabilistic case ascertainment using health administrative data enables robust population-level estimation of OSA epidemiology despite the absence of clinical diagnostic data and provides a framework for studying OSA prevalence, correlates, and outcomes over time.
OBJECTIVES:To describe preoperative testing for iron-deficiency anemia in cardiac surgery, including its prevalence and impact on outcomes. DESIGN:Retrospective cohort study. SETTING:Single academic center. PARTICIPANTS:A total of 5,960 consecutive adults undergoing coronary artery bypass grafting (CABG), valve, or combined CABG/valve surgery, of whom 338 (5.7%) had iron-deficiency anemia, 1,918 (32.2%) had unspecified anemia, and 3,704 (62.1%) had no anemia. INTERVENTIONS:None. MEASUREMENTS AND MAIN RESULTS:Associations between preoperative iron-deficiency anemia (ferritin ≤100 µg/L or ferritin ≤300 µg/L and transferrin saturation ≤20%), survival at 30 and 365 days, and resource utilization were analyzed using Cox proportional hazards, quantile regression, and negative binomial regression. After adjustment, compared to nonanemic patients, those with iron-deficiency anemia had higher 30-day (hazard ratio [HR], 1.91; 95% confidence interval [CI], 1.22 to 2.98; p = 0.004) and 365-day mortality (HR, 2.78; 95% CI, 2.13 to 3.62; p < 0.001), longer intensive care unit (HR, 0.84; 95% CI, 0.76 to 0.94; p = 0.002) and hospital length of stay (HR, 0.75; 95% CI, 0.68 to 0.83; p < 0.001), decreased median days alive at home (-3.71; 95% CI, -7.16 to -0.27; p = 0.03), and higher risk of emergency department (ED) visits at 1 year (incident rate ratio [IRR], 1.36; 95% CI, 1.15 to 1.61; p < 0.001). Iron-deficiency anemia was also associated with higher 365-day mortality (HR, 1.48; 95% CI, 1.17 to 1.88; p = 0.001) and ED visits at 1 year (IRR, 1.26; 95% CI, 1.07 to 1.50; p = 0.007) compared to unspecified anemia. CONCLUSIONS:Among cardiac surgery patients, preoperative iron-deficiency anemia is associated with decreased survival and higher health care utilization compared to patients with no anemia and unspecified anemia.
BACKGROUND:Whether a hospital policy of tranexamic acid administration for patients undergoing major noncardiac surgery safely reduces the need for red-cell transfusion is uncertain. METHODS:We conducted a multicenter, double-blind, cluster-randomized, placebo-controlled trial involving patients undergoing noncardiac surgery who were at high risk for red-cell transfusion. Hospitals were randomly assigned at 4-week intervals to a hospital-wide policy of intraoperative tranexamic acid or placebo. The coprimary effectiveness and safety outcomes were transfusion of red cells during the index hospitalization and diagnosis of venous thromboembolism within 90 days, respectively. The safety outcome was assessed for noninferiority, with a prespecified noninferiority margin defined as an upper boundary of 1.46 for the 95% confidence interval of the relative risk. Analyses used mixed-effects models that accounted for the cluster-crossover design. RESULTS:A total of 8273 patients enrolled across 10 Canadian hospitals could be evaluated for the coprimary outcomes. Oncologic surgery accounted for 60.5% of the surgical procedures (5002 of 8273). The percentage of patients who received a red-cell transfusion during hospitalization was 7.4% (306 of 4156) in the tranexamic acid group and 9.8% (403 of 4117) in the placebo group (relative risk, 0.73; 95% confidence interval [CI], 0.61 to 0.86; adjusted difference, -2.7 percentage points; 95% CI, -4.2 to -1.4). Venous thromboembolism within 90 days occurred in 2.1% of patients (86 of 4128) in the tranexamic acid group and 2.1% of patients (85 of 4052) in the placebo group (relative risk, 0.96; 95% CI, 0.65 to 1.38; adjusted difference, -0.1 percentage points; 95% CI, -0.9 to 0.7), which met the criterion for noninferiority. CONCLUSIONS:Among patients undergoing major noncardiac surgery, a hospital policy of tranexamic acid administration resulted in a lower incidence of red-cell transfusion than placebo administration, and tranexamic acid was noninferior to placebo with regard to diagnosis of venous thromboembolism. (Funded by the Canadian Institutes of Health Research and others; TRACTION ClinicalTrials.gov number, NCT04803747.).