Effect of video-based self-reflection on intraoperative skills: A pilot randomized controlled trial.

BACKGROUND: The value of video-based self-assessment in enhancing surgical skills is uncertain. This study investigates the feasibility and estimates sample size for a full-scale randomized controlled trial to evaluate the effectiveness of video-based self-assessment to improve surgical performance of laparoscopic cholecystectomy in trainees. METHODS: This parallel pilot randomized controlled trial included general surgery trainees performing supervised laparoscopic cholecystectomy randomized 1:1 to control (traditional intraoperative teaching) or intervention group (traditional teaching plus video-based self-assessment). Operative performance was measured by the attending surgeon blinded to group assignment at the time of surgery using standardized assessment tools (Global Operative Assessment of Laparoscopic Skills and Operative Performance Rating System). The intervention group had access to their video recordings on a web-based platform for review and self-assessment using the same instruments. The primary outcome for the estimation of sample size was the difference in faculty-assessed final operative performance (third submitted case). Feasibility criteria included >85% participation, >85% adherence to case submission and >85% completion of self-assessment. RESULTS: Of 37 eligible trainees approached, 32 consented and were randomized (86%). There were 16 in the intervention group, 15 in the control group (55% male, 55% junior trainees), and 1 was excluded for protocol violation. Twenty-four (75%) of participants submitted 3 cases. Thirteen trainees (81%) accessed the platform and completed 26 (63.2%) case self-assessments. Fifty-five trainees per arm will be needed to power a full-scale laparoscopic cholecystectomy with Global Operative Assessment of Laparoscopic Skills and 130 trainees per arm with Operative Performance Rating System as the assessment tool. CONCLUSION: This pilot study contributes important data to inform the design of an adequately powered randomized controlled trial of video-based self-assessment to improve trainee performance of laparoscopic cholecystectomy. Although a priori trial feasibility criteria were not achieved, automated video capture and storage could significantly improve adherence in future trials.

S110-Opioid-free analgesia after outpatient general surgery: A qualitative study focused on the perspectives of patients and clinicians involved in a pilot trial.

BACKGROUND: Opioid-free analgesia (OFA) may mitigate opioid-related harms after outpatient general surgery; however, the comparative effectiveness of this approach should be assessed in robust randomized controlled trials (RCTs). Undertaking an RCT on OFA raises important practical concerns, including surgeon and patient hesitation regarding pain management without opioids. We conducted a qualitative study to explore patients' and clinicians' perspectives and experiences with a pilot trial focused on OFA after outpatient general surgery. METHODS: Patients undergoing outpatient abdominal and breast procedures were randomized to receive post-discharge opioid analgesia (OA) or OFA. Semi-structured interviews with patients and clinicians involved in the trial were conducted to elicit personal perspectives and experiences. Purposive sampling for maximum variation was used to recruit participants with diverse characteristics. Transcribed interviews were assessed using inductive thematic analysis. RESULTS: Ten patients (5 abdominal, 5 breast) and 10 clinicians (6 surgeons, 2 anesthesiologists, 2 nurses) were interviewed. Five major themes emerged: readiness for trial engagement, pre-trial thoughts about the interventions, postoperative pain experiences, intervention acceptability, and trial refinement. Most patients were open to OFA. Clinicians expressed willingness to prescribe OFA, particularly after less invasive procedures and when using peripheral nerve blocks (PNBs). Concerns were raised regarding the adequacy of pain control and side effects of non-opioid drugs (e.g., NSAID-induced bleeding, kidney injury). Overall, participants were enthusiastic about the trial and recognized its relevance; clinicians praised the study design and organization; and patients valued the use of electronic questionnaires. Suggestions for improvements included preventing potential bias arising from the use of PNBs (i.e., via standardization or stratification) and reducing patient burden (i.e., decreasing postoperative questionnaires). CONCLUSION: Patients and clinicians who participated in a pilot RCT generally accept the clinical equipoise between OA versus OFA after outpatient general surgery and recognize the need for methodologically robust trials to inform evidence-based analgesia prescribing.

Validity of video-based general and procedure-specific self-assessment tools for surgical trainees in laparoscopic cholecystectomy.

INTRODUCTION: Self-review of recorded surgical procedures offers new opportunities for trainees to extend technical learning outside the operating-room. Valid tools for self-assessment are required prior to evaluating the effectiveness of video-review in enhancing technical learning. Therefore, we aimed to contribute evidence regarding the validity of intraoperative performance assessment tools for video-based self-assessment by general surgery trainees when performing laparoscopic cholecystectomies. METHODS AND PROCEDURES: Using a web-based platform, general surgery trainees in a university-based residency program submitted recorded laparoscopic cholecystectomy procedures where they acted as the supervised primary surgeon. Attending surgeons measured operative performance at the time of surgery using general and procedure-specific assessment tools [Global Operative Assessment of Laparoscopic Skills (GOALS) and Operative Performance Rating System (OPRS), respectively] and entrustability level (O-SCORE). Trainees self-evaluated their performance from video-review using the same instruments. The validity of GOALS and OPRS for trainee self-assessment was investigated by testing the hypotheses that self-assessment scores correlate with (H1) expert assessment scores, (H2) O-SCORE, and (H3) procedure time and that (H4) self-assessment based on these instruments differentiates junior [postgraduate year (PGY) 1-3] and senior trainees (PGY 4-5), as well as (H5)simple [Visual Analogue Scale (VAS) ≤ 4] versus complex cases (VAS > 4). All hypotheses were based on previous literature, defined a priori, and were tested according to the COSMIN consensus on measurement properties. RESULTS: A total of 35 videos were submitted (45% female and 45% senior trainees) and self-assessed. Our data supported 2 out of 5 hypotheses (H1 and H4) for GOALS and 3 out of 5 hypotheses (H1, H4 and H5) for OPRS, for trainee self-assessment. CONCLUSIONS: OPRS, a procedure-specific assessment tool, was better able to differentiate between groups expected to have different levels of intraoperative performance, compared to GOALS, a general assessment tool. Given the interest in video-based learning, there is a need to further develop valid procedure-specific tools to support video-based self-assessment by trainees in a range of procedures.

Feasibility of Prospectively Comparing Opioid Analgesia With Opioid-Free Analgesia After Outpatient General Surgery: A Pilot Randomized Clinical Trial.

Importance: The overprescription of opioids to surgical patients is recognized as an important factor contributing to the opioid crisis. However, the value of prescribing opioid analgesia (OA) vs opioid-free analgesia (OFA) after postoperative discharge remains uncertain. Objective: To investigate the feasibility of conducting a full-scale randomized clinical trial (RCT) to assess the comparative effectiveness of OA vs OFA after outpatient general surgery. Design, Setting, and Participants: This parallel, 2-group, assessor-blind, pragmatic pilot RCT was conducted from January 29 to September 3, 2020 (last follow-up on October 2, 2020). at 2 university-affiliated hospitals in Montreal, Quebec, Canada. Participants were adult patients (aged ≥18 years) undergoing outpatient abdominal (ie, cholecystectomy, appendectomy, or hernia repair) or breast (ie, partial or total mastectomy) general surgical procedures. Exclusion criteria were contraindications to drugs used in the trial, preoperative opioid use, conditions that could affect assessment of outcomes, and intraoperative or early complications requiring hospitalization. Interventions: Patients were randomized 1:1 to receive OA (around-the-clock nonopioids and opioids for breakthrough pain) or OFA (around-the-clock nonopioids with increasing doses and/or addition of nonopioid medications for breakthrough pain) after postoperative discharge. Main Outcomes and Measures: Main outcomes were a priori RCT feasibility criteria (ie, rates of surgeon agreement, patient eligibility, patient consent, treatment adherence, loss to follow-up, and missing follow-up data). Secondary outcomes included pain intensity and interference, analgesic intake, 30-day unplanned health care use, and adverse events. Between-group comparison of outcomes followed the intention-to-treat principle. Results: A total of 15 surgeons were approached; all (100%; 95% CI, 78%-100%) agreed to have patients recruited and adhered to the study procedures. Rates of patient eligibility and consent were 73% (95% CI, 66%-78%) and 57% (95% CI, 49%-65%), respectively. Seventy-six patients were randomized (39 [51%] to OA and 37 [49%] to OFA) and included in the intention-to-treat analysis (mean [SD] age, 55.5 [14.5] years; 50 [66%] female); 40 (53%) underwent abdominal surgery, and 36 (47%) underwent breast surgery. Seventy-five patients (99%; 95% CI, 93%-100%) adhered to the allocated treatment; 1 patient randomly assigned to OFA received an opioid prescription. Seventeen patients (44%) randomly assigned to OA consumed opioids after discharge. Seventy-three patients (96%; 95% CI, 89%-99%) completed the 30-day follow-up. The rate of missing questionnaires was 37 of 3724 (1%; 95% CI, 0.7%-1.4%). All the a priori RCT feasibility criteria were fulfilled. Conclusions and Relevance: The findings of this pilot RCT support the feasibility of conducting a robust, full-scale RCT to inform evidence-based prescribing of analgesia after outpatient general surgery. Trial Registration: ClinicalTrials.gov Identifier: NCT04254679.

Establishing validity evidence for device-assisted advanced laparoscopic suturing tasks using simulation.

BACKGROUND: Laparoscopic suturing (LS) is an essential technique required for a wide range of procedures, and it is one of the most challenging for surgical trainees to master. We designed and collected validity evidence for advanced LS tasks using an automated suturing device and evaluated the perceived educational value of the tasks. METHODS: This project was a multicentre prospective study involving McGill University, University of Toronto (UofT), and Louisiana State University (LSU) Health New Orleans. Novice (NS) and experienced (ES) surgeons performed suturing under tension (UT) and continuous suturing (CS) tasks. ES performed the tasks twice to establish proficiency benchmarks, and they were interviewed to develop formative feedback tools (FFT). Participants were assessed on completion time, error, Global Operative Assessment of Laparoscopic Skills (GOALS), and FFT. Data were analyzed using descriptive and inferential statistical methods. RESULTS: Twenty-seven participants (13 ES, 14 NS, median age 34 years; 85% male) completed the study. Eight were attending surgeons, 7 fellows, 4 PGY5, 5 PGY4, and 3 PGY3 (18 from McGill, 5 UofT, and 4 LSU). Comparing ES and NS, for UT task, ES had significantly greater task scores (570 [563-648] vs 323 [130-464], p value 0.00036) and GOALS scores (14 [13-16] vs 10 [8-12], p value 0.0038). Similarly, for CS, ES had significantly greater task scores (976 [959-1010] vs 785 [626-856], p value 0.00009) and GOALS scores (16 [12-17] vs 12.5 [8.25-15], p value 0.028). After FFTs were developed, comparing ES and NS, for both UT and CS tasks, ES had significantly greater FFT scores (UT 25 [24-26] vs 17 [14-20], p value 0.0016 and CS 30 [27-32] vs 22[17.2-25.8], p value 0.00061). CONCLUSION: In conclusion, preliminary validity evidence was provided for the tasks. Once further validity evidence is established, incorporating the tasks into the training curricula could improve trainee skills and help to meet the need for better advanced suturing models.

The association between video-based assessment of intraoperative technical performance and patient outcomes: a systematic review.

BACKGROUND: Efforts to improve surgical safety and outcomes have traditionally placed little emphasis on intraoperative performance, partly due to difficulties in measurement. Video-based assessment (VBA) provides an opportunity for blinded and unbiased appraisal of surgeon performance. Therefore, we aimed to systematically review the existing literature on the association between intraoperative technical performance, measured using VBA, and patient outcomes. METHODS: Major databases (Medline, Embase, Cochrane Database, and Web of Science) were systematically searched for studies assessing the association of intraoperative technical performance measured by tools supported by validity evidence with short-term (≤ 30 days) and/or long-term postoperative outcomes. Study quality was assessed using the Newcastle-Ottawa Scale. Results were appraised descriptively as study heterogeneity precluded meta-analysis. RESULTS: A total of 11 observational studies were identified involving 8 different procedures in foregut/bariatric (n = 4), colorectal (n = 4), urologic (n = 2), and hepatobiliary surgery (n = 1). The number of surgeons assessed ranged from 1 to 34; patient sample size ranged from 47 to 10,242. High risk of bias was present in 5 of 8 studies assessing short-term outcomes and 2 of 6 studies assessing long-term outcomes. Short-term outcomes were reported in 8 studies (i.e., morbidity, mortality, and readmission), while 6 reported long-term outcomes (i.e., cancer outcomes, weight loss, and urinary continence). Better intraoperative performance was associated with fewer postoperative complications (6 of 7 studies), reoperations (3 of 4 studies), and readmissions (1 of 4 studies). Long-term outcomes were less commonly investigated, with mixed results. CONCLUSION: Current evidence supports an association between superior intraoperative technical performance measured using surgical videos and improved short-term postoperative outcomes. Intraoperative performance analysis using video-based assessment represents a promising approach to surgical quality-improvement.

Construct validity and responsiveness of the Duke Activity Status Index (DASI) as a measure of recovery after colorectal surgery.

BACKGROUND: Returning to preoperative levels of physical function is highly valued by patients recovering from surgery. The Duke Activity Status Index (DASI, a 12-item questionnaire) may be a simple yet robust tool to assess postoperative recovery of functional capacity. This study assessed construct validity and responsiveness of the DASI as a measure of recovery after colorectal surgery. METHODS: Data from a trial on early mobilization after colorectal surgery were analyzed. Patients completed the DASI questionnaire preoperatively and at postoperative weeks (POW) 2 and 4. Construct validity was assessed by testing the primary a priori hypotheses that postoperative DASI scores (1) are higher in patients without vs with postoperative complications and (2) correlate with six-minute walk test distance (6MWD). Exploratory analyses assessed the association between DASI scores and (1) preoperative physical status [higher (ASA ≤ 2) vs lower (ASA > 2)], (2) stoma creation (no stoma vs stoma), (3) age [younger (≤ 75 years) vs older (> 75 years)], (4) time to readiness for discharge [shorter (≤ 4 days) vs longer (> 4 days)], and (5) surgical approach (laparoscopic vs open). Responsiveness was assessed by testing a priori hypotheses that DASI scores are higher (1) preoperatively vs at POW2 and (2) at POW4 vs POW2. Mean differences in DASI scores were obtained using linear regression. The association between DASI and 6MWD was assessed via Pearson correlation. RESULTS: We analyzed data from 100 patients undergoing colorectal surgery (mean age 65; 57% male; 81% laparoscopic). Mean DASI scores were 47.9 ± 12.1 preoperatively, 22.4 ± 12.7 at POW2, and 33.2 ± 15.7 at POW4. The data supported our two primary construct validity hypotheses, as well as 3/5 exploratory hypotheses. Both responsiveness hypotheses were supported. CONCLUSIONS: Our findings support that the DASI questionnaire can be a useful tool to assess postoperative recovery of functional capacity in research and clinical practice.

The impact of the first wave of the COVID-19 pandemic on the exposure of general surgery trainees to operative procedures.

INTRODUCTION: During the COVID-19 pandemic, the redeployment of operating room (OR) staff resulted in a significant ramp-down of elective surgery. To mitigate the negative effects of the pandemic on surgical education, this study was planned to estimate the impact of the first wave of the pandemic on the participation of general surgery residency and fellowship trainees in operative procedures. METHODS: This study is a retrospective review of all adult general surgery procedures performed at 3 sites of an academic health care network. Cases performed during the first wave of the pandemic (March-June 2020) were compared to the same period of the previous year pre-pandemic (March-June 2019). Trainees were categorized as junior (Post-Graduate-Year [PGY] 1-2), senior (PGY3-5), or fellows (PGY6-7). Operating exposure was defined as (1) the total number of cases attended by at least one trainee and (2) total time spent in the OR by all trainees (hours). The impact of the pandemic was estimated as percentage of baseline (2019). RESULTS: During the first wave of the pandemic, a total of 914 cases were performed, compared to 1328 in the pre-pandemic period (69%). Junior trainees were more affected than senior trainees with reductions in both case volume (68% versus 78% of baseline attendance) and time (68% versus 77% of baseline operating time). Minimally invasive surgery fellows were most severely affected trainees and colorectal fellows were least affected (14% and 75% of baseline cases, respectively). Participation in emergency surgery cases and surgical oncology cases was relatively preserved (87% and 105% of baseline, respectively). CONCLUSIONS: The first wave of the COVID-19 pandemic reduced operative exposure for general surgery trainees by approximately 30%. Procedure-specific patterns reflected institutional policies for prioritizing cancer operations and emergency surgeries. These findings may inform the design of remediation activities to mitigate the impact of the pandemic on surgical training.

Impact of the Covid-19 pandemic on rates of emergency department utilization and hospital admission due to general surgery conditions.

BACKGROUND: Recent literature reports a decrease in healthcare-seeking behaviours by adults during the Covid-19 pandemic. Given that emergency general surgery (GS) conditions are often associated with high morbidity and mortality if left untreated, the objective of this study was to describe and quantify the impact of the Covid-19 pandemic on rates of emergency department (ED) utilization and hospital admission due to GS conditions. METHODS: This cohort study involved the analysis of an institutional database and retrospective chart review. We identified adult patients presenting to the ED in a network of three teaching hospitals in Montreal, Canada during the first wave of the Covid-19 pandemic (March13-May13, 2020) and a control pre-pandemic period (March13-May13, 2019). Patients with GS conditions were included in the analysis. ED utilization rates, admission rates and 30-day outcomes were compared between the two periods using multivariate regression analysis. RESULTS: During the pandemic period, 258 patients presented to ED with a GS diagnosis compared to 351 patients pre-pandemically (adjusted rate ratio (aRR) 0.75; p < 0.001). Rate of hospital admission during the pandemic was also significantly lower (aRR = 0.77, p < 0.001). Patients had a significantly shorter ED stay during the pandemic (adjusted mean difference 5.0 h; p < 0.001). Rates of operative management during the pandemic were preserved compared to the pre-pandemic period. There were no differences in 30-day complications (adjusted odds ratio (aOR) 1.46; p = 0.07), ED revisits (aOR 1.10; p = 0.66) and (re)admissions (aOR 1.42; p = 0.22) between the two periods. CONCLUSION: There was a decrease in rates of ED utilization and hospital admissions due to GS conditions during the first wave of the Covid -19 pandemic; however, rates of operative management, complications and healthcare reutilization were unchanged. Although our findings are not generalizable to patients who did not seek healthcare, it was possible to successfully uphold institutional standards of care once patients presented to the ED.

Systematic review of grading systems for adverse surgical outcomes.

Background: Grading scales for adverse surgical outcomes have been poorly characterized to date. The primary aim of this study was to conduct a systematic review to enumerate the various frameworks for grading adverse postoperative outcomes; our secondary objective was to outline the properties of each grading system, identifying its strengths and weaknesses. Methods: We searched 9 databases (Africa Wide Information, Biosis, Cochrane, Embase, Global Health, LILACs, Medline, PubMed and Web of Science) from 1992 (the year the Clavien-Dindo classification system was developed) until Mar. 2, 2017, for studies that aimed to develop or improve on an already existing generalizable system for grading adverse postoperative outcomes. Study selection was duplicated as per PRISMA recommendations. Procedure-specific grading systems were excluded. We assessed the framework, strengths and weaknesses of the systems qualitatively. Results: We identified 9 studies on 8 adverse outcome grading systems with frameworks generalizable to any surgical procedure. Most systems have not been widely incorporated in the literature. Seven of the 8 systems were produced without including patients' perspectives. Four allowed the derivation of a composite morbidity score, which had limited tangible significance for patients. Conclusion: Although each instrument identified offered its own advantages, none satisfied the need for a patient-centred tool capable of generating a composite score of all possible postoperative adverse outcomes (complications, sequelae and failure) that enables comparison of noninterventional and surgical management of disease. There is a need for development of a more comprehensive, patient-centred grading system for adverse postoperative outcomes.

Contexte: Jusqu'ici, les systèmes de classification des issues postopératoires indésirables n'ont pas encore fait l'objet d'une analyse comparative. Cette étude avait pour objectif principal de recenser, au moyen d'une revue systématique de la littérature, les divers systèmes de classification des issues postopératoire indésirables, et pour objectif secondaire de dégager les propriétés, les forces et les faiblesses de chaque système. Méthodes: Nous avons interrogé 9 bases de données (Africa Wide Information, Biosis Previews, Cochrane, Embase, Global Health, LILACS, Medline, PubMed et Web of Science) pour trouver des articles publiés entre 1992 (année de la mise au point du système de classification de Clavien­Dindo) et le 2 mars 2017. Ces articles devaient porter sur la création d'un système généralisable de classification des issues postopératoires indésirables, ou l'amélioration d'un système existant. La sélection des études a été faite en double, conformément aux recommandations PRISMA. Les systèmes de classification visant une seule intervention ont été exclus. Nous avons évalué, d'un point de vue qualitatif, le cadre, les forces et les faiblesses des systèmes retenus. Résultats: Nous avons retenu 9 études sur 8 systèmes de classification accompagnés d'un cadre pouvant être appliqué à n'importe quelle intervention chirurgicale. La plupart des systèmes n'avaient pas été largement étudiés. Sept des 8 systèmes avaient été développés sans tenir compte du point de vue des patients, et 4 permettaient de calculer un score de morbidité composite ayant des retombées concrètes limitées pour les patients. Conclusion: Tous les systèmes retenus s'accompagnaient d'avantages, mais aucun ne pouvait servir d'outil centré sur le patient permettant de calculer un score composite pour toutes les issues postopératoires possibles (complications, séquelles et échec), score qui pourrait servir à comparer les prises en charge conservatrice et chirurgicale des maladies. La création d'un système de classification des issues postopératoires indésirables exhaustif centré sur le patient est nécessaire.

Impact of Facilitation of Early Mobilization on Postoperative Pulmonary Outcomes After Colorectal Surgery: A Randomized Controlled Trial.

OBJECTIVE: To estimate the extent to which staff-directed facilitation of early mobilization impacts recovery of pulmonary function and 30-day postoperative pulmonary complications (PPCs) after colorectal surgery. SUMMARY BACKGROUND DATA: Early mobilization after surgery is believed to improve pulmonary function and prevent PPCs; however, adherence is low. The value of allocating resources (eg, staff time) to increase early mobilization is unknown. METHODS: This study involved the analysis of a priori secondary outcomes of a pragmatic, observer-blind, randomized trial. Consecutive patients undergoing colorectal surgery were randomized 1:1 to usual care (preoperative education) or facilitated mobilization (staff dedicated to assist transfers and walking during hospital stay). Forced vital capacity, forced expiratory volume in 1 second (FEV1), and peak cough flow were measured preoperatively and at 1, 2, 3 days and 4 weeks after surgery. PPCs were defined according to the European Perioperative Clinical Outcome Taskforce. RESULTS: Ninety-nine patients (57% male, 80% laparoscopic, median age 63, and predicted FEV1 97%) were included in the intention-to-treat analysis (usual care 49, facilitated mobilization 50). There was no between-group difference in recovery of forced vital capacity [adjusted difference in slopes 0.002 L/d (95% CI -0.01 to 0.01)], FEV1 [-0.002 L/d (-0.01 to 0.01)] or peak cough flow [-0.002 L/min/d (-0.02 to 0.02)]. Thirty-day PPCs were also not different between groups [adjusted odds ratio 0.67 (0.23-1.99)]. CONCLUSIONS: In this randomized controlled trial, staff-directed facilitation of early mobilization did not improve postoperative pulmonary function or reduce PPCs within an enhanced recovery pathway for colorectal surgery. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02131844.

A mobile device application (app) to improve adherence to an enhanced recovery program for colorectal surgery: a randomized controlled trial.

BACKGROUND: Increased adherence with enhanced recovery pathways (ERP) is associated with improved outcomes. However, adherence to postoperative elements that rely on patient participation remains suboptimal. Mobile device apps may improve delivery of health education material and have the potential to foster behavior change and improve patient compliance. The objective of this study was to estimate the extent to which a novel mobile device app affects adherence to an ERP for colorectal surgery in comparison to standard written education. METHODS: This was a superiority, parallel-group, assessor-blind, sham-controlled randomized trial involving 97 patients undergoing colorectal resection. Participants were randomly assigned with a 1:1 ratio into one of two groups: (1) iPad including a novel mobile device app for postoperative education and self-assessment of recovery, or (2) iPad without the app. The primary outcome measure was mean adherence (%) to a bundle of five postoperative ERP elements requiring patient participation: mobilization, gastrointestinal motility stimulation, breathing exercises, and consumption of oral liquids and nutritional drinks. RESULTS: In the intervention group, app usage was high (94% completed surveys on POD0, 82% on POD1, 72% on POD2). Mean overall adherence to the bundle on the two first postoperative days was similar between groups: 59% (95% CI 52-66%) in the intervention group and 62% (95% CI 56-68%) in the control group [Adjusted mean difference 2.4% (95% CI - 5 to 10%) p = 0.53]. CONCLUSIONS: In this randomized trial, access to a mobile health application did not improve adherence to a well-established enhanced recovery pathway in colorectal surgery patients, when compared to standard written patient education. Future research should evaluate the impact of applications integrating novel behavioral change techniques, particularly in contexts where adherence is low.

Incidence and prevalence of congenital anomalies in low- and middle-income countries: A systematic review.

BACKGROUND: In the absence of robust data from low- and middle-income countries (LMICs), most disease burden estimates and related resource allocation choices are based on historic Northern demographics. We hypothesize that significant discrepancies exist between directly reported LMIC data and surrogate high-income country (HIC) disease burden estimates of correctible congenital anomalies. METHODS: Nine online databases were searched for studies reporting incidence and prevalence data on surgically correctible congenital anomalies in LMICs between 2006 and 2017. Two independent reviewers screened titles and abstracts, with a third adjudicating discrepancies. Selected studies were reviewed and analyzed. RESULTS: Of 10,128 identified articles, 98 were extracted for full-text review, and 41 were included, representing 21 LMICs and 18 conditions. Study types included community surveys (34%), prospective (22%) and retrospective (17%) multi-site data, registries (12%), single-site data (12%), and systematic reviews (5%). Data collection periods were 1 to 10 years. The pooled epidemiologic data varied systematically from existing HIC literature, with the incidence of disease being generally lower in LMICs. CONCLUSIONS: Marked discrepancies exist between reported epidemiological data in LMICs and HIC literature, in part owing to varying quality of data collection in LMICs. Robust population-based surveys are needed to accurately estimate the burden of surgically correctable congenital anomalies in LMICs. LEVEL OF EVIDENCE: Level V, expert opinion without explicit critical appraisal.

Does adherence to perioperative enhanced recovery pathway elements influence patient-reported recovery following colorectal resection?

INTRODUCTION: Patient-reported outcome measures (PROMs) are pivotal to promote patient-centered perioperative care. Adherence to enhanced recovery programs (ERPs) is associated with improved clinical outcomes (i.e., morbidity, length of stay), but the impact of adherence on PROMs is uncertain. The objective of this study was to evaluate the extent to which adherence to an ERP for colorectal surgery is associated with postoperative recovery as assessed using PROMs. METHODS AND PROCEDURES: 100 patients were included [median age 63 (IQR 50-71) years, 81 laparoscopic, 37 rectal surgery]. Overall adherence to the ERP and adherence to specific ERP elements were analyzed. Adjusted linear regression was used to evaluate the association of adherence with PROMs assessing early recovery [Abdominal surgery impact scale (ASIS) and Multidimensional fatigue inventory (MFI) on POD2] and late recovery (Duke Activity Status Index, RAND-36 Physical and Mental Summary Scores, Life-Space Mobility Assessment at 4 weeks after surgery). Missing data were addressed using multiple imputations. RESULTS: Median adherence to the ERP was 80% (16/20 elements, IQR 70-90%). Overall adherence was associated with ASIS scores on POD2 (4% increase per additional element, 95% CI 1-8%; p = 0.018). When specific ERP elements were analyzed, ASIS scores were associated with adherence to PONV prophylaxis (34% increase, 95% CI 5-63%; p = 0.023) and early solid food diet (20% increase, 95% CI 5-35%; p = 0.009). MFI General fatigue and MFI Mental fatigue scores on POD2 were associated with adherence to PONV prophylaxis (36% decrease, 95% CI - 64 to - 8%, p = 0.014 and 22% decrease, 95% CI - 44 to - 8%, p = 0.042). Overall adherence and adherence to specific elements were not associated with PROMs at 4 weeks after surgery. CONCLUSION: Our findings suggest that, from the perspective of patients, adherence to an ERP for colorectal surgery impacts early, but not late postoperative recovery. This result may reflect the lack of PROMs able to validly measure postoperative recovery beyond hospital discharge.

Construct Validity and Responsiveness of the Abdominal Surgery Impact Scale in the Context of Recovery After Colorectal Surgery.

BACKGROUND: The Abdominal Surgery Impact Scale is a patient-reported outcome measure that evaluates quality of life after abdominal surgery. Evidence supporting its measurement properties is limited. OBJECTIVE: This study aimed to contribute evidence for the construct validity and responsiveness of the Abdominal Surgery Impact Scale as a measure of recovery after colorectal surgery in the context of an enhanced recovery pathway. DESIGN: This is an observational validation study designed according to the Consensus-based Standards for the Selection of Health Measurement Instruments checklist. SETTING: This study was conducted at a university-affiliated tertiary hospital. PATIENTS: Included were 100 consecutive patients undergoing colorectal surgery (mean age, 65; 57% male). INTERVENTION: There were no interventions. MAIN OUTCOME MEASURES: Construct validity was assessed at 2 days and 2 and 4 weeks after surgery by testing the hypotheses that Abdominal Surgery Impact Scale scores were higher 1) in patients without vs with postoperative complications, 2) with higher preoperative physical status vs lower, 3) without vs with postoperative stoma, 4) in men vs women, 5) with shorter time to readiness for discharge (≤4 days) vs longer, and 6) with shorter length of stay (≤4 days) vs longer. To test responsiveness, we hypothesized that scores would be higher 1) preoperatively vs 2 days postoperatively, 2) at 2 weeks vs 2 days postoperatively, and 3) at 4 weeks vs 2 weeks postoperatively. RESULTS: The data supported 3 of the 6 hypotheses (hypotheses 1, 5, and 6) tested for construct validity at all time points. Two of the 3 hypotheses tested for responsiveness (hypotheses 1 and 2) were supported. LIMITATIONS: This study was limited by the risk of selection bias due to the use of secondary data from a randomized controlled trial. CONCLUSIONS: The Abdominal Surgery Impact Scale was responsive to the expected trajectory of recovery up to 2 weeks after surgery, but did not discriminate between all groups expected to have different recovery trajectories. There remains a need for the development of recovery-specific, patient-reported outcome measures with adequate measurement properties. See Video Abstract at http://links.lww.com/DCR/A814.

Measuring In-Hospital Recovery After Colorectal Surgery Within a Well-Established Enhanced Recovery Pathway: A Comparison Between Hospital Length of Stay and Time to Readiness for Discharge.

BACKGROUND: Hospital length of stay is often used as a measure of in-hospital recovery but may be confounded by organizational factors. Time to readiness for discharge may provide a superior index of recovery. OBJECTIVE: The purpose of this study was to contribute evidence for the construct validity of time to readiness for discharge and length of stay as measures of in-hospital recovery after colorectal surgery in the context of a well-established enhanced recovery pathway. DESIGN: This was an observational validation study designed according to the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) checklist. SETTINGS: The study was conducted at a university-affiliated tertiary hospital. PATIENTS: A total of 100 consecutive patients undergoing elective colorectal resection (mean age = 65 y; 57% men; 81% laparoscopic) who participated in a randomized controlled trial were included. MAIN OUTCOME MEASURES: We tested a priori hypotheses that length of stay and time-to-readiness for discharge are longer in patients undergoing open surgery, with lower physical status, with severe comorbidities, with postoperative complications, undergoing rectal surgery, who are older (≥75 y), who have a new stoma, and who have inflammatory bowel disease. RESULTS: Median time-to-readiness for discharge and length of stay were both 3 days. For both measures, 6 of 8 construct validity hypotheses were supported (hypotheses 1 and 4-8). LIMITATIONS: The use of secondary data from a randomized controlled trial (risk of selection bias) was a limitation. Results may not be generalizable to institutions where patient care is not equally structured. CONCLUSIONS: This study contributes evidence to the construct validity of time-to-readiness for discharge and length of stay as measures of in-hospital recovery within enhanced recovery pathways. Our findings suggest that length of stay can be a less resource-intensive and equally construct-valid index of in-hospital recovery compared with time-to-readiness for discharge. Enhanced recovery pathways may decrease process-of-care variances that impact length of stay, allowing more timely discharge once discharge criteria are achieved. See Video Abstract at http://links.lww.com/DCR/A564.

Development of a patient-reported outcome measure of recovery after abdominal surgery: a hypothesized conceptual framework.

BACKGROUND: We initiated a research program to develop a novel patient-reported outcome measure (PROM) to assess postoperative recovery from the perspective of abdominal surgery patients. In light of FDA recommendations, the first stage of our program aimed to, based on previous literature and expert input, develop a hypothesized conceptual framework portraying the health domains that are potentially relevant to the process of recovery after abdominal surgery. METHODS: This study was conducted in three phases: (1) systematic review to identify PROMs with measurement properties appraised in the context of recovery after abdominal surgery, (2) content analysis to categorize the health domains covered by the PROMs according to the ICF, and (3) two-round Delphi study to gain expert input regarding which of these health domains are relevant to the process of recovery. Participants were experts in perioperative care identified through two major surgical societies (35 invited). RESULTS: The systematic review identified 19 PROMs covering 66 ICF domains. 23 experts (66%) participated in the Delphi process. After Round 2, experts agreed that 22 health domains (8 body functions, 14 activities and participation) are potentially relevant to the process of recovery after abdominal surgery. These domains were organized into a diagram, representing our hypothesized conceptual framework. CONCLUSIONS: This hypothesized conceptual framework is an important first step in our research program and will be further refined based on in-depth qualitative interviews with patients. The sound methodological approach used to derive this framework may be valuable for studies aimed to develop PROMs according to FDA standards.

How Do We Value Postoperative Recovery?: A Systematic Review of the Measurement Properties of Patient-reported Outcomes After Abdominal Surgery.

OBJECTIVE: To appraise the level of evidence supporting the measurement properties of patient-reported outcome measures (PROMs) in the context of postoperative recovery after abdominal surgery. BACKGROUND: There is growing interest in using PROMs to support value-based care in abdominal surgery; however, to draw valid conclusions regarding patient-reported outcomes data, PROMs with robust measurement properties are required. METHODS: Eight databases (MEDLINE, EMBASE, Biosis, PsycINFO, The Cochrane Library, CINAHL, Scopus, Web of Science) were searched for studies focused on the measurement properties of PROMs in the context of recovery after abdominal surgery. The methodological quality of individual studies was evaluated using the consensus-based COSMIN checklist. Evidence supporting the measurement properties of each PROM was synthetized according to standardized criteria and compared against the International Society of Quality of Life Research minimum standards for the selection of PROMs for outcomes research. RESULTS: We identified 35 studies evaluating 22 PROMs [12 focused on nonspecific surgical populations (55%), 4 focused on abdominal surgery (18%), and 6 generic PROMs (27%)]. The great majority of the studies (74%) received only poor or fair quality ratings. Measurement properties of PROMs were predominantly supported by limited or unknown evidence. None of the PROMs fulfilled International Society of Quality of Life Research's minimum standards, hindering specific recommendations. CONCLUSIONS: There is very limited evidence supporting the measurement properties of existing PROMs used in the context of recovery after abdominal surgery. This precludes the use of these PROMs to support value-based surgical care. Further research is required to bridge this major knowledge gap. REVIEW REGISTRATION: International Prospective Register of Systematic Reviews (PROSPERO): CRD42014014349.

Ensuring Early Mobilization Within an Enhanced Recovery Program for Colorectal Surgery: A Randomized Controlled Trial.

OBJECTIVE: To estimate the extent to which the addition of staff-directed facilitation of early mobilization to an Enhanced Recovery Program (ERP) impacts recovery after colorectal surgery, compared with usual care. SUMMARY BACKGROUND DATA: Early mobilization is considered an important component of ERPs but, despite guidelines recommendations, adherence remains quite low. The value of dedicating specific resources (eg, staff time) to increase early mobilization is unknown. METHODS: This randomized trial involved 99 colorectal surgery patients in an established ERP (median age 63, 57% male, 80% laparoscopic) randomized 1:1 to usual care (including preoperative education about early mobilization with postoperative daily targets) or facilitated mobilization [staff dedicated to assist transfers and walking from postoperative days (PODs) 0-3]. Primary outcome was the proportion of patients returning to preoperative functional walking capacity (6-min walk test) at 4 weeks after surgery. We also explored the association of the intervention with in-hospital mobilization, time to achieve discharge criteria, time to recover gastrointestinal function, 30-day comprehensive complication index, and patient-reported outcome measures. RESULTS: In the facilitated mobilization group, adherence to mobilization targets was greater on POD0 [OR 4.7 (95% CI 1.8-11.9)], POD1 [OR 6.5 (95% CI 2.3-18.3)], and POD2 [OR 3.7 (95% CI 1.2-11.3)]. Step count was at least 2-fold greater on POD1 [mean difference 843.3 steps (95% CI 219.5-1467.1)] and POD2 [mean difference 1099.4 steps (95% CI 282.7-1916.1)] There was no between-group difference in recovery of walking capacity at 4 weeks after surgery [OR 0.77 (95% CI 0.30-1.97)]. Other outcome measures were also not different between groups. CONCLUSIONS: In an ERP for colorectal surgery, staff-directed facilitation of early mobilization increased out-of-bed activities during hospital stay but did not improve outcomes. This study does not support the value of allocating additional resources to ensure early mobilization in ERPs. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02131844.