Perioperative Care of Patients Using Wearable Diabetes Devices.

The increasing prevalence of diabetes mellitus has been accompanied by a rapid expansion in wearable continuous glucose monitoring (CGM) devices and insulin pumps. Systems combining these components in a "closed loop," where interstitial glucose measurement guides automated insulin delivery (AID, or closed loop) based on sophisticated algorithms, are increasingly common. While these devices' efficacy in achieving near-normoglycemia is contributing to increasing usage among patients with diabetes, the management of these patients in operative and procedural environments remains understudied with limited published guidance available, particularly regarding AID systems. With their growing prevalence, practical management advice is needed for their utilization, or for the rational temporary substitution of alternative diabetes monitoring and treatments, during surgical care. CGM devices monitor interstitial glucose in real time; however, there are potential limitations to use and accuracy in the perioperative period, and, at the present time, their use should not replace regular point-of-care glucose monitoring. Avoiding perioperative removal of CGMs when possible is important, as removal of these prescribed devices can result in prolonged interruptions in CGM-informed treatments during and after procedures, particularly AID system use. Standalone insulin pumps provide continuous subcutaneous insulin delivery without automated adjustments for glucose concentrations and can be continued during some procedures. The safe intraoperative use of AID devices in their hybrid closed-loop mode (AID mode) requires the CGM component of the system to continue to communicate valid blood glucose data, and thus introduces the additional need to ensure this portion of the system is functioning appropriately to enable intraprocedural use. AID devices revert to non-AID insulin therapy modes when paired CGMs are disconnected or when the closed-loop mode is intentionally disabled. For patients using insulin pumps, we describe procedural factors that may compromise CGM, insulin pump, and AID use, necessitating a proactive transition to an alternative insulin regimen. Procedure duration and invasiveness is an important factor as longer procedures increase the risk of stress hyperglycemia, tissue malperfusion, and device malfunction. Whether insulin pumps should be continued through procedures, or substituted by alternative insulin delivery methods, is a complex decision that requires all parties to understand potential risks and contingency plans relating to patient and procedural factors. Currently available CGMs and insulin pumps are reviewed, and practical recommendations for safe glycemic management during the phases of perioperative care are provided.

Reducing perioperative red blood cell unit issue orders, returns, and waste using failure modes and effects analysis.

BACKGROUND: Surgical transfusion has an outsized impact on hospital-based transfusion services, leading to blood product waste and unnecessary costs. The objective of this study was to design and implement a streamlined, reliable process for perioperative blood issue ordering and delivery to reduce waste. STUDY DESIGN AND METHODS: To address the high rates of surgical blood issue requests and red blood cell (RBC) unit waste at a large academic medical center, a failure modes and effects analysis was used to systematically examine perioperative blood management practices. Based on identified failure modes (e.g., miscommunication, knowledge gaps), a multi-component action plan was devised involving process changes, education, electronic clinical decision support, audit, and feedback. Changes in RBC unit issue requests, returns, waste, labor, and cost were measured pre- and post-intervention. RESULTS: The number of perioperative RBC unit issue requests decreased from 358 per month (SD 24) pre-intervention to 282 per month (SD 16) post-intervention (p < .001), resulting in an estimated savings of 8.9 h per month in blood bank staff labor. The issue-to-transfusion ratio decreased from 2.7 to 2.1 (p < .001). Perioperative RBC unit waste decreased from 4.5% of units issued pre-intervention to 0.8% of units issued post-intervention (p < .001), saving an estimated $148,543 in RBC unit acquisition costs and $546,093 in overhead costs per year. DISCUSSION: Our intervention, designed based on a structured failure modes analysis, achieved sustained reductions in perioperative RBC unit issue orders, returns, and waste, with associated benefits for blood conservation and transfusion program costs.

Postoperative Delirium Severity and Recovery Correlate With Electroencephalogram Spectral Features.

BACKGROUND: Delirium is an acute syndrome characterized by inattention, disorganized thinking, and an altered level of consciousness. A reliable biomarker for tracking delirium does not exist, but oscillations in the electroencephalogram (EEG) could address this need. We evaluated whether the frequencies of EEG oscillations are associated with delirium onset, severity, and recovery in the postoperative period. METHODS: Twenty-six adults enrolled in the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES; ClinicalTrials.gov NCT02241655) study underwent major surgery requiring general anesthesia, and provided longitudinal postoperative EEG recordings for this prespecified substudy. The presence and severity of delirium were evaluated with the confusion assessment method (CAM) or the CAM-intensive care unit. EEG data obtained during awake eyes-open and eyes-closed states yielded relative power in the delta (1-4 Hz), theta (4-8 Hz), and alpha (8-13 Hz) bands. Discriminability for delirium presence was evaluated with c-statistics. To account for correlation among repeated measures within patients, mixed-effects models were generated to assess relationships between: (1) delirium severity and EEG relative power (ordinal), and (2) EEG relative power and time (linear). Slopes of ordinal and linear mixed-effects models are reported as the change in delirium severity score/change in EEG relative power, and the change in EEG relative power/time (days), respectively. Bonferroni correction was applied to confidence intervals (CIs) to account for multiple comparisons. RESULTS: Occipital alpha relative power during eyes-closed states offered moderate discriminability (c-statistic, 0.75; 98% CI, 0.58-0.87), varying inversely with delirium severity (slope, -0.67; 98% CI, -1.36 to -0.01; P = .01) and with severity of inattention (slope, -1.44; 98% CI, -2.30 to -0.58; P = .002). Occipital theta relative power during eyes-open states correlated directly with severity of delirium (slope, 1.28; 98% CI, 0.12-2.44; P = .007), inattention (slope, 2.00; 98% CI, 0.48-3.54; P = .01), and disorganized thinking (slope, 3.15; 98% CI, 0.66-5.65; P = .01). Corresponding frontal EEG measures recapitulated these relationships to varying degrees. Severity of altered level of consciousness correlated with frontal theta relative power during eyes-open states (slope, 11.52; 98% CI, 6.33-16.71; P < .001). Frontal theta relative power during eyes-open states correlated inversely with time (slope, -0.05; 98% CI, -0.12 to -0.04; P = .002). CONCLUSIONS: Presence, severity, and core features of postoperative delirium covary with spectral features of the EEG. The cost and accessibility of EEG facilitate the translation of these findings to future mechanistic and interventional trials.

Personalized Surgical Transfusion Risk Prediction Using Machine Learning to Guide Preoperative Type and Screen Orders.

BACKGROUND: Accurate estimation of surgical transfusion risk is essential for efficient allocation of blood bank resources and for other aspects of anesthetic planning. This study hypothesized that a machine learning model incorporating both surgery- and patient-specific variables would outperform the traditional approach that uses only procedure-specific information, allowing for more efficient allocation of preoperative type and screen orders. METHODS: The American College of Surgeons National Surgical Quality Improvement Program Participant Use File was used to train four machine learning models to predict the likelihood of red cell transfusion using surgery-specific and patient-specific variables. A baseline model using only procedure-specific information was created for comparison. The models were trained on surgical encounters that occurred at 722 hospitals in 2016 through 2018. The models were internally validated on surgical cases that occurred at 719 hospitals in 2019. Generalizability of the best-performing model was assessed by external validation on surgical cases occurring at a single institution in 2020. RESULTS: Transfusion prevalence was 2.4% (73,313 of 3,049,617), 2.2% (23,205 of 1,076,441), and 6.7% (1,104 of 16,053) across the training, internal validation, and external validation cohorts, respectively. The gradient boosting machine outperformed the baseline model and was the best- performing model. At a fixed 96% sensitivity, this model had a positive predictive value of 0.06 and 0.21 and recommended type and screens for 36% and 30% of the patients in internal and external validation, respectively. By comparison, the baseline model at the same sensitivity had a positive predictive value of 0.04 and 0.144 and recommended type and screens for 57% and 45% of the patients in internal and external validation, respectively. The most important predictor variables were overall procedure-specific transfusion rate and preoperative hematocrit. CONCLUSIONS: A personalized transfusion risk prediction model was created using both surgery- and patient-specific variables to guide preoperative type and screen orders and showed better performance compared to the traditional procedure-centric approach.

Abnormal preoperative cognitive screening in aged surgical patients: a retrospective cohort analysis.

BACKGROUND: Preoperative cognitive dysfunction has been associated with adverse postoperative outcomes. There are limited data characterising the epidemiology of preoperative cognitive dysfunction in older surgical patients. METHODS: This retrospective cohort included all patients ≥65 yr old seen at the Washington University preoperative clinic between January 2013 and June 2018. Cognitive screening was performed using the Short-Blessed Test (SBT) and Eight-Item Interview to Differentiate Aging and Dementia (AD8) screen. The primary outcome of abnormal cognitive screening was defined as SBT score ≥5 or AD8 score ≥2. Multivariable logistic regression was used to identify associated factors. RESULTS: Overall, 21 666 patients ≥65 yr old completed screening during the study period; 23.5% (n=5099) of cognitive screens were abnormal. Abnormal cognitive screening was associated with increasing age, decreasing BMI, male sex, non-Caucasian race, decreased functional independence, and decreased metabolic functional capacity. Patients with a history of stroke or transient ischaemic attack, chronic obstructive pulmonary disease, diabetes mellitus, hepatic cirrhosis, and heavy alcohol use were also more likely to have an abnormal cognitive screen. Predictive modelling showed no combination of patient factors was able to reliably identify patients who had a <10% probability of abnormal cognitive screening. CONCLUSIONS: Routine preoperative cognitive screening of unselected aged surgical patients often revealed deficits consistent with cognitive impairment or dementia. Such deficits were associated with increased age, decreased function, decreased BMI, and several common medical comorbidities. Further research is necessary to characterise the clinical implications of preoperative cognitive dysfunction and identify interventions that may reduce related postoperative complications.

Effect of electroencephalogram-guided anaesthesia administration on 1-yr mortality: follow-up of a randomised clinical trial.

BACKGROUND: Intraoperative EEG suppression duration has been associated with postoperative delirium and mortality. In a clinical trial testing anaesthesia titration to avoid EEG suppression, the intervention did not decrease the incidence of postoperative delirium, but was associated with reduced 30-day mortality. The present study evaluated whether the EEG-guided anaesthesia intervention was also associated with reduced 1-yr mortality. METHODS: This manuscript reports 1 yr follow-up of subjects from a single-centre RCT, including a post hoc secondary outcome (1-yr mortality) in addition to pre-specified secondary outcomes. The trial included subjects aged 60 yr or older undergoing surgery with general anaesthesia between January 2015 and May 2018. Patients were randomised to receive EEG-guided anaesthesia or usual care. The previously reported primary outcome was postoperative delirium. The outcome of the current study was all-cause 1-yr mortality. RESULTS: Of the 1232 subjects enrolled, 614 subjects were randomised to EEG-guided anaesthesia and 618 subjects to usual care. One-year mortality was 57/591 (9.6%) in the guided group and 62/601 (10.3%) in the usual-care group. No significant difference in mortality was observed (adjusted absolute risk difference, -0.7%; 99.5% confidence interval, -5.8% to 4.3%; P=0.68). CONCLUSIONS: An EEG-guided anaesthesia intervention aiming to decrease duration of EEG suppression during surgery did not significantly decrease 1-yr mortality. These findings, in the context of other studies, do not provide supportive evidence for EEG-guided anaesthesia to prevent intermediate term postoperative death. CLINICAL TRIAL REGISTRATION: NCT02241655.

Preoperative Cognitive Abnormality, Intraoperative Electroencephalogram Suppression, and Postoperative Delirium: A Mediation Analysis.

BACKGROUND: Postoperative delirium is a common complication that hinders recovery after surgery. Intraoperative electroencephalogram suppression has been linked to postoperative delirium, but it is unknown if this relationship is causal or if electroencephalogram suppression is merely a marker of underlying cognitive abnormalities. The hypothesis of this study was that intraoperative electroencephalogram suppression mediates a nonzero portion of the effect between preoperative abnormal cognition and postoperative delirium. METHODS: This is a prespecified secondary analysis of the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) randomized trial, which enrolled patients age 60 yr or older undergoing surgery with general anesthesia at a single academic medical center between January 2015 and May 2018. Patients were randomized to electroencephalogram-guided anesthesia or usual care. Preoperative abnormal cognition was defined as a composite of previous delirium, Short Blessed Test cognitive score greater than 4 points, or Eight Item Interview to Differentiate Aging and Dementia score greater than 1 point. Duration of intraoperative electroencephalogram suppression was defined as number of minutes with suppression ratio greater than 1%. Postoperative delirium was detected via Confusion Assessment Method or chart review on postoperative days 1 to 5. RESULTS: Among 1,113 patients, 430 patients showed evidence of preoperative abnormal cognition. These patients had an increased incidence of postoperative delirium (151 of 430 [35%] vs.123 of 683 [18%], P < 0.001). Of this 17.2% total effect size (99.5% CI, 9.3 to 25.1%), an absolute 2.4% (99.5% CI, 0.6 to 4.8%) was an indirect effect mediated by electroencephalogram suppression, while an absolute 14.8% (99.5% CI, 7.2 to 22.5%) was a direct effect of preoperative abnormal cognition. Randomization to electroencephalogram-guided anesthesia did not change the mediated effect size (P = 0.078 for moderation). CONCLUSIONS: A small portion of the total effect of preoperative abnormal cognition on postoperative delirium was mediated by electroencephalogram suppression. Study precision was too low to determine if the intervention changed the mediated effect.

Association between postoperative complications and lingering post-surgical pain: an observational cohort study.

BACKGROUND: Post-surgical pain that lingers beyond the initial few-week period of tissue healing is a major predictor of pain chronification, which leads to substantial disability and new persistent opioid analgesic use. We investigated whether postoperative medical complications increase the risk of lingering post-surgical pain. METHODS: The study population consisted of patients undergoing diverse elective surgical procedures in an academic referral centre in the USA, between September 2013 and May 2017. Multivariable logistic regression, adjusting for confounding variables and patient-specific risk factors, was used to test for an independent association between any major postoperative complication and functionally limiting lingering pain 1-3 months after surgery, as obtained from patient self-reports. RESULTS: The cohort included 11 986 adult surgical patients; 10 562 with complete data. At least one complication (cardiovascular, respiratory, renal/gastrointestinal, wound, thrombotic, or neural) was reported by 13.3% (95% confidence interval: 12.7-14.0) of patients, and 19.7% (19.0-20.5%) reported functionally limiting lingering post-surgical pain. After adjusting for known risk factors, the patients were twice as likely (odds ratio: 2.04; 1.78-2.35) to report lingering post-surgical pain if they also self-reported a postoperative complication. Experiencing a complication was also independently predictive of lingering post-surgical pain (odds ratio: 1.95; 1.26-3.04) when complication data were extracted from the National Surgical Quality Improvement Program registry, instead of being obtained from patient self-report. CONCLUSIONS: Medical complications were associated with a two-fold increase in functionally limiting pain 1-3 months after surgery. Understanding the mechanisms that link complications to pathological persistence of pain could help develop future approaches to prevent persistent post-surgical pain.

Practical Training of Anesthesia Clinicians in Electroencephalogram-Based Determination of Hypnotic Depth of General Anesthesia.

BACKGROUND: Electroencephalographic (EEG) brain monitoring during general anesthesia provides information on hypnotic depth. We hypothesized that anesthesia clinicians could be trained rapidly to recognize typical EEG waveforms occurring with volatile-based general anesthesia. METHODS: This was a substudy of a trial testing the hypothesis that EEG-guided anesthesia prevents postoperative delirium. The intervention was a 35-minute training session, summarizing typical EEG changes with volatile-based anesthesia. Participants completed a preeducational test, underwent training, and completed a posteducational test. For each question, participants indicated whether the EEG was consistent with (1) wakefulness, (2) non-slow-wave anesthesia, (3) slow-wave anesthesia, or (4) burst suppression. They also indicated whether the processed EEG (pEEG) index was discordant with the EEG waveforms. Four clinicians, experienced in intraoperative EEG interpretation, independently evaluated the EEG waveforms, resolved disagreements, and provided reference answers. Ten questions were assessed in the preeducational test and 9 in the posteducational test. RESULTS: There were 71 participants; 13 had previous anesthetic-associated EEG interpretation training. After training, the 58 participants without prior training improved at identifying dominant EEG waveforms (median 60% with interquartile range [IQR], 50%-70% vs 78% with IQR, 67%-89%; difference: 18%; 95% confidence interval [CI], 8-27; P < .001). In contrast, there was no significant improvement following the training for the 13 participants who reported previous training (median 70% with IQR, 60%-80% vs 67% with IQR, 67%-78%; difference: -3%; 95% CI, -18 to 11; P = .88). The difference in the change between the pre- and posteducational session for the previously untrained versus previously trained was statistically significant (difference in medians: 21%; 95% CI, 2-28; P = .005). Clinicians without prior training also improved in identifying discordance between the pEEG index and the EEG waveform (median 60% with IQR, 40%-60% vs median 100% with IQR, 75%-100%; difference: 40%; 95% CI, 30-50; P < .001). Clinicians with prior training showed no significant improvement (median 60% with IQR, 60%-80% vs 75% with IQR, 75%-100%; difference: 15%; 95% CI, -16 to 46; P = .16). Regarding the identification of discordance, the difference in the change between the pre- and posteducational session for the previously untrained versus previously trained was statistically significant (difference in medians: 25%; 95% CI, 5-45; P = .012). CONCLUSIONS: A brief training session was associated with improvements in clinicians without prior EEG training in (1) identifying EEG waveforms corresponding to different hypnotic depths and (2) recognizing when the hypnotic depth suggested by the EEG was discordant with the pEEG index.

Intraoperative Awareness With Recall: A Descriptive, Survey-Based, Cohort Study.

BACKGROUND: Unintended intraoperative awareness with recall (AWR) is a potential complication of general anesthesia. Patients typically report recollections of (1) hearing sounds or conversations, (2) being unable to breathe or move, (3), feeling pain, and/or (4) experiencing emotional distress. The purpose of the current study was to identify and further characterize AWR experiences identified through postoperative surveys of a large unselected adult surgical cohort. METHODS: This is a substudy of a prospective registry study, which surveys patients on their health and well-being after surgery. Responses to 4 questions focusing on AWR were analyzed. Patients who reported AWR with pain, paralysis, and/or distress were contacted by telephone to obtain more information about their AWR experience. The interview results for patients who received general anesthesia were sent to 3 anesthesiologists, who adjudicated the reported AWR episodes. RESULTS: Of 48,151 surveys sent, 17,875 patient responses were received. Of these respondents, 622 reported a specific memory from the period between going to sleep and waking up from perceived general anesthesia and 282 of these reported related pain, paralysis, and/or distress. An attempt was made to contact these 282 patients, and 149 participated in a telephone survey. Among the 149 participants, 87 endorsed their prior report of AWR. However, only 22 of these patients had received general anesthesia, while 51 received only sedation and 14 received regional anesthesia. Three anesthesiologists independently adjudicated the survey results of the 22 general anesthesia cases and assigned 6 as definite AWR, 8 as possible AWR, and 8 as not AWR episodes. Of the 65 patients who confirmed their report of AWR after regional or sedation anesthesia, 37 (31 with sedation and 6 with regional anesthesia) had not expected to be conscious during surgery. CONCLUSIONS: The complication of AWR continues to occur during intended general anesthesia. Many reports of AWR episodes occur in patients receiving sedation or regional anesthesia and relate to incorrect expectations regarding anesthetic techniques and conscious experiences, representing a potential target for intervention.

Effect of Electroencephalography-Guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery: The ENGAGES Randomized Clinical Trial.

Importance: Intraoperative electroencephalogram (EEG) waveform suppression, often suggesting excessive general anesthesia, has been associated with postoperative delirium. Objective: To assess whether EEG-guided anesthetic administration decreases the incidence of postoperative delirium. Design, Setting, and Participants: Randomized clinical trial of 1232 adults aged 60 years and older undergoing major surgery and receiving general anesthesia at Barnes-Jewish Hospital in St Louis. Recruitment was from January 2015 to May 2018, with follow-up until July 2018. Interventions: Patients were randomized 1:1 (stratified by cardiac vs noncardiac surgery and positive vs negative recent fall history) to receive EEG-guided anesthetic administration (n = 614) or usual anesthetic care (n = 618). Main Outcomes and Measures: The primary outcome was incident delirium during postoperative days 1 through 5. Intraoperative measures included anesthetic concentration, EEG suppression, and hypotension. Adverse events included undesirable intraoperative movement, intraoperative awareness with recall, postoperative nausea and vomiting, medical complications, and death. Results: Of the 1232 randomized patients (median age, 69 years [range, 60 to 95]; 563 women [45.7%]), 1213 (98.5%) were assessed for the primary outcome. Delirium during postoperative days 1 to 5 occurred in 157 of 604 patients (26.0%) in the guided group and 140 of 609 patients (23.0%) in the usual care group (difference, 3.0% [95% CI, -2.0% to 8.0%]; P = .22). Median end-tidal volatile anesthetic concentration was significantly lower in the guided group than the usual care group (0.69 vs 0.80 minimum alveolar concentration; difference, -0.11 [95% CI, -0.13 to -0.10), and median cumulative time with EEG suppression was significantly less (7 vs 13 minutes; difference, -6.0 [95% CI, -9.9 to -2.1]). There was no significant difference between groups in the median cumulative time with mean arterial pressure below 60 mm Hg (7 vs 7 minutes; difference, 0.0 [95% CI, -1.7 to 1.7]). Undesirable movement occurred in 137 patients (22.3%) in the guided and 95 (15.4%) in the usual care group. No patients reported intraoperative awareness. Postoperative nausea and vomiting was reported in 48 patients (7.8%) in the guided and 55 patients (8.9%) in the usual care group. Serious adverse events were reported in 124 patients (20.2%) in the guided and 130 (21.0%) in the usual care group. Within 30 days of surgery, 4 patients (0.65%) in the guided group and 19 (3.07%) in the usual care group died. Conclusions and Relevance: Among older adults undergoing major surgery, EEG-guided anesthetic administration, compared with usual care, did not decrease the incidence of postoperative delirium. This finding does not support the use of EEG-guided anesthetic administration for this indication. Trial Registration: ClinicalTrials.gov Identifier: NCT02241655.

Frailty Phenotypes and Relations With Surgical Outcomes: A Latent Class Analysis.

BACKGROUND: Frailty is an important concept in the care of older adults although controversy remains regarding its defining features and clinical utility. Both the Fried phenotype and the Rockwood deficit accumulation approaches cast frailty as a "burden" without exploring the relative salience of its cardinal markers and their relevance to the patient. New multifactorial perspectives require a reliable assessment of frailty that can validly predict postoperative health outcomes. METHODS: In a retrospective study of 2828 unselected surgical patients, we used item response theory to examine the ability of 32 heterogeneous markers capturing limitations in physical, functional, emotional, and social activity domains to indicate severity of frailty as a latent continuum. Eighteen markers efficiently indicated frailty severity and were then subject to latent class analysis to derive discrete phenotypes. Next, we validated the obtained frailty phenotypes against patient-reported 30-day postoperative outcomes using multivariable logistic regression. Models were adjusted for demographics, comorbidity, type and duration of surgery, and cigarette and alcohol consumption. RESULTS: The 18 markers provided psychometric evidence of a single reliable continuum of frailty severity. Latent class analyses produced 3 distinct subtypes, based on patients' endorsement probabilities of the frailty indicators: not frail (49.7%), moderately frail (33.5%), and severely frail (16.7%). Unlike the moderate class, severely frail endorsed emotional health problems in addition to physical burdens and functional limitations. Models adjusting for age, sex, type of anesthesia, and intraoperative factors indicated that severely frail (odds ratio, 1.89; 95% confidence interval, 1.42-2.50) and moderately frail patients (odds ratio, 1.31; 95% confidence interval, 1.03-1.67) both had higher odds of experiencing postoperative complications compared to not frail patients. In a 3-way comparison, a higher proportion of severely frail patients (10.7%) reported poorer quality of life after surgery compared to moderately frail (9.2%) and not frail (8.3%) patients (P < .001). There was no significant difference among these groups in proportions reporting hospital readmission (5.6%, 5.1%, and 3.8%, respectively; P = .067). CONCLUSIONS: Self-report frailty items can accurately discern 3 distinct phenotypes differing in composition and their relations with surgical outcomes. Systematically assessing a wider set of domains including limitations in functional, emotional, and social activities can inform clinicians on what precipitates loss of physiological reserve and profoundly influences patients' lives. This information can help guide the current discussion on frailty and add meaningful clinical tools to the surgical practice.

Achieving Milestones as a Prerequisite for Proceeding With a Clinical Trial.

BACKGROUND: Although the National Institutes of Health (NIH) invests $30 billion in research annually, many funded studies fail to generate results that can inform practice. The National Institutes of Health introduced a phased funding mechanism as one potential solution. Study-specific milestones are established for an initial pilot phase. We assess the utility of this phased approach through the ongoing Electroencephalography (EEG) Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) pragmatic clinical trial. The hypothesis of the trial is that EEG guidance of general anesthesia, through prevention of EEG suppression, can decrease postoperative delirium and its downstream negative sequelae. METHODS: In collaboration with study stakeholders, we identified critical milestones for the ENGAGES study, with themes common to many clinical trials. These themes include: regulatory tasks; enrollment targets; feasibility and impact of study intervention; primary outcome incidence; measurement reliability of primary outcome; and follow-up. Progress in achieving the milestones was assessed at regular intervals during the pilot phase by ENGAGES investigators, a National Institute on Aging program officer, and a nonpartisan research organization (Westat). RESULTS: Regulatory tasks, including institutional review board approval, infrastructure establishment, and trial registration, were completed on schedule. A total of 117 patients were randomized, exceeding the target by 51. The EEG-guided protocol was successfully implemented, and a relevant effect on anesthetic practice was demonstrated (decrease in median age-adjusted minimum alveolar anesthetic concentration from 0.93 to 0.78 [P < .001] and increase in median proportion of zero EEG suppression time from 87% to 94% [P < .01]). Nearly all patients (115 of 117, 98.3%) were assessed for delirium using the Confusion Assessment Method, and the delirium incidence was similar (28.1%; 95% CI, 20%-37%) to the estimate (25%) used for the sample size calculation. Good interrater reliability of delirium assessment was demonstrated (κ = 0.94 [95% CI, 0.86-1]). Finally, 1-month follow-up vital status data were obtained for 96.9% of patients, with 85.7% of patients completing at least 1 survey. CONCLUSIONS: With the ENGAGES trial, we demonstrated that key milestones can be identified and progressively assessed during a pilot phase. Success in attaining appropriate milestones hypothetically predicts meaningful completion of a study, and can provide justification for proceeding beyond a pilot phase. The impact of this phased approach on return on investment and scientific yield requires additional study.

Changes in quality of life after elective surgery: an observational study comparing two measures.

PURPOSE: Our main objective was to compare the change in a validated quality of life measure to a global assessment measure. The secondary objectives were to estimate the minimum clinically important difference (MCID) and to describe the change in quality of life by surgical specialty. METHODS: This prospective cohort study included 7902 adult patients undergoing elective surgery. Changes in the Veterans RAND 12-Item Health Survey (VR-12), composed of a physical component summary (PCS) and a mental component summary (MCS), were calculated using preoperative and postoperative questionnaires. The latter also contained a global assessment question for quality of life. We compared PCS and MCS to the global assessment using descriptive statistics and weighted kappa. MCID was calculated using an anchor-based approach. Analyses were pre-specified and registered (NCT02771964). RESULTS: By the change in VR-12 scores, an equal proportion of patients experienced improvement and deterioration in quality of life (28% for PCS, 25% for MCS). In contrast, by the global assessment measure, 61% reported improvement, while only 10% reported deterioration. Agreement with the global assessment was slight for both PCS (kappa = 0.20, 57% matched) and MCS (kappa = 0.10, 54% matched). The MCID for the overall VR-12 score was approximately 2.5 points. Patients undergoing orthopedic surgery showed the most improvement in quality of life measures, while patients undergoing gastrointestinal/hepatobiliary or urologic surgery showed the most deterioration. CONCLUSIONS: Subjective global quality of life report does not agree well with a validated quality of life instrument, perhaps due to patient over-optimism.

Methodologic Considerations for Collecting Patient-reported Outcomes from Unselected Surgical Patients.

BACKGROUND: The impact of surgery on health is only appreciated long after hospital discharge. Furthermore, patients' perceptions of postoperative health are not routinely ascertained. The authors instituted the Systematic Assessment and Targeted Improvement of Services Following Yearlong Surgical Outcomes Surveys (SATISFY-SOS) registry to evaluate patients' postoperative health based on patient-reported outcomes (PROs). METHODS: This article describes the methods of establishing the SATISFY-SOS registry from an unselected surgical population, combining perioperative PROs with information from electronic medical records. Patients enrolled during their preoperative visit were surveyed at enrollment, 30 days, and 1-yr postoperatively. Information on PROs, including quality of life, return to work, pain, functional status, medical complications, and cognition, was obtained from online, mail, or telephone surveys. RESULTS: Using structured query language, 44,081 patients were identified in the electronic medical records as having visited the Center for Preoperative Assessment and Planning for preoperative assessment between July 16, 2012, and June 15, 2014, and 20,719 patients (47%) consented to participate in SATISFY-SOS. Baseline characteristics and health status were similar between enrolled and not enrolled patients. The response rate for the 30-day survey was 62% (8% e-mail, 73% mail, and 19% telephone) and for the 1-yr survey was 71% (13% e-mail, 78% mail, and 8% telephone). CONCLUSIONS: SATISFY-SOS demonstrates the feasibility of establishing a PRO registry reflective of a busy preoperative assessment center population, without disrupting clinical workflow. Our experience suggests that patient engagement, including informed consent and multiple survey modalities, enhances PROs collection from a large cohort of unselected surgical patients. Initiatives like SATISFY-SOS could promote quality improvement, enable efficient perioperative research, and facilitate outcomes that matter to surgical patients.

Preoperative Falls and Their Association with Functional Dependence and Quality of Life.

BACKGROUND: No study has rigorously explored the characteristics of surgical patients with recent preoperative falls. Our objective was to describe the essential features of preoperative falls and determine whether they are associated with preoperative functional dependence and poor quality of life. METHODS: This was an observational study involving 15,060 surveys from adult patients undergoing elective surgery. The surveys were collected between January 2014 and August 2015, with a response rate of 92%. RESULTS: In the 6 months before surgery, 26% (99% CI, 25 to 27%) of patients fell at least once, and 12% (99% CI, 11 to 13%) fell at least twice. The proportion of patients who fell was highest among patients presenting for neurosurgery (41%; 99% CI, 36 to 45%). At least one fall-related injury occurred in 58% (99% CI, 56 to 60%) of those who fell. Falls were common in all age groups, but surprisingly, they did not increase monotonically with age. Middle-aged patients (45 to 64 yr) had the highest proportion of fallers (28%), recurrent fallers (13%), and severe fall-related injuries (27%) compared to younger (18 to 44 yr) and older (65+ yr) patients (P < 0.001 for each). A fall within 6 months was independently associated with preoperative functional dependence (odds ratio, 1.94; 99% CI, 1.68 to 2.24) and poor physical quality of life (odds ratio, 2.18; 99% CI, 1.88 to 2.52). CONCLUSIONS: Preoperative falls might be common and are possibly often injurious in the presurgical population, across all ages. A history of falls could enhance the assessment of preoperative functional dependence and quality of life.

Convergent Validity of Three Methods for Measuring Postoperative Complications.

BACKGROUND: Anesthesiologists need tools to accurately track postoperative outcomes. The accuracy of patient report in identifying a wide variety of postoperative complications after diverse surgical procedures has not previously been investigated. METHODS: In this cohort study, 1,578 adult surgical patients completed a survey at least 30 days after their procedure asking if they had experienced any of 18 complications while in the hospital after surgery. Patient responses were compared to the results of an automated electronic chart review and (for a random subset of 750 patients) to a manual chart review. Results from automated chart review were also compared to those from manual chart review. Forty-two randomly selected patients were contacted by telephone to explore reasons for discrepancies between patient report and manual chart review. RESULTS: Comparisons between patient report, automated chart review, and manual chart review demonstrated poor-to-moderate positive agreement (range, 0 to 58%) and excellent negative agreement (range, 82 to 100%). Discordance between patient report and manual chart review was frequently explicable by patients reporting events that happened outside the time period of interest. CONCLUSIONS: Patient report can provide information about subjective experiences or events that happen after hospital discharge, but often yields different results from chart review for specific in-hospital complications. Effective in-hospital communication with patients and thoughtful survey design may increase the quality of patient-reported complication data.

The impact of obesity on complications of elbow, forearm, and hand surgeries.

PURPOSE: To compare the rates of postoperative complications in obese and nonobese patients following elbow, forearm, and hand surgeries. METHODS: This case-control study examined 436 patients whose body mass index (BMI) was over 35 and who underwent hand, wrist, forearm, or elbow surgery between 2009 and 2013. Controls were patients (n = 433) with a BMI less than 30 who had similar surgeries over the same period, and who were frequency-matched by type of surgery (ie, bony, soft tissue, or nerve), age, and sex. Postoperative complications were defined as infection requiring antibiotic or reoperation, delayed incision healing, nerve dysfunction, wound dehiscence, hematoma, and other reoperation. Medical comorbidities (e.g., hypertension, diabetes, stroke, vascular disease, kidney disease, and liver disease) were recorded. Chi-square analyses were performed to explore the association between obesity and postoperative complications. Similar analyses were performed stratified by surgery type and BMI classification. Logisticregression modeling was performed to identify predictors of postoperative complications accounting for surgery type, BMI, the presence of comorbidities, patient age, and patient sex. This same model was also run separately for case and control patients. RESULTS: The overall complication rate was 8.7% with similar rates between obese and nonobese patients (8.5% vs. 9.0%). Bony procedures resulted in the greatest risk of complication in both groups (15% each group). Multivariate analysis confirmed surgery type as the only significant predictor of complications for nonobese patients. However, among obese patients, both bony surgery and increasing BMI were associated with greater complication rates. CONCLUSIONS: Not all obese patients appear to be at any higher risk for complications after elbow, forearm, and hand surgery compared with nonobese patients. However, there appears to be a dose-dependent effect of BMI among obese patients such that increasing obesity heightens the risk of complications, especially for those with a BMI greater than 45. TYPE OF STUDY/LEVEL OF EVIDENCE: Prognostic II.