Impact of enhanced recovery pathways on patient-reported outcomes after abdominal surgery: a systematic review.

INTRODUCTION: Evidence supports that enhanced recovery pathways (ERPs) reduce length of stay and complications; however, these measures may not reflect the perspective of patients who are the main stakeholders in the recovery process. This systematic review aimed to appraise the evidence regarding the impact of ERPs on patient-reported outcomes (PROs) after abdominal surgery. METHODS: Five databases (Medline, Embase, Biosis, Cochrane, and Web of Science) were searched for randomized controlled trials (RCTs) addressing the impact of ERPs on PROs after abdominal surgery. We focused on distinct periods of recovery: early (within 7 days postoperatively) and late (beyond 7 days). Risk of bias was assessed using Cochrane's RoB 2.0. Results were appraised descriptively as heterogeneity hindered meta-analysis. Certainty of evidence was evaluated using GRADE. RESULTS: Fifty-six RCTs were identified [colorectal (n = 18), hepatopancreaticobiliary (HPB) (n = 11), upper gastrointestinal (UGI) (n = 10), gynecological (n = 7), urological (n = 7), general surgery (n = 3)]. Most trials had 'some concerns' (n = 30) or 'high' (n = 25) risk of bias. In the early postoperative period, ERPs improved patient-reported general health (colorectal, HPB, UGI, urological; very low to low certainty), physical health (colorectal, gynecological; very low to low certainty), mental health (colorectal, gynecological; very low certainty), pain (all specialties; very low to moderate certainty), and fatigue (colorectal; low certainty). In the late postoperative period, ERPs improved general health (HPB, UGI, urological; very low certainty), physical health (UGI, gynecological, urological; very low to low certainty), mental health (UGI, gynecological, urological; very low certainty), social health (gynecological; very low certainty), pain (gynecological, urological; very low certainty), and fatigue (gynecological; very low certainty). CONCLUSION: This review supports that ERPs may have a positive impact on patient-reported postoperative health status (i.e., general, physical, mental, and social health) and symptom experience (i.e., pain and fatigue) after abdominal surgery; however, data were largely derived from low-quality trials. Although these findings contribute important knowledge to inform evidence-based ERP implementation, there remains a great need to improve PRO assessment in studies focused on postoperative recovery.

Opioid versus opioid-free analgesia after surgical discharge: a systematic review and meta-analysis of randomised trials.

BACKGROUND: Excessive opioid prescribing after surgery has contributed to the current opioid crisis; however, the value of prescribing opioids at surgical discharge remains uncertain. We aimed to estimate the extent to which opioid prescribing after discharge affects self-reported pain intensity and adverse events in comparison with an opioid-free analgesic regimen. METHODS: In this systematic review and meta-analysis, we searched MEDLINE, Embase, the Cochrane Library, Scopus, AMED, Biosis, and CINAHL from Jan 1, 1990, until July 8, 2021. We included multidose randomised controlled trials comparing opioid versus opioid-free analgesia in patients aged 15 years or older, discharged after undergoing a surgical procedure according to the Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity definition (minor, moderate, major, and major complex). We screened articles, extracted data, and assessed risk of bias (Cochrane's risk-of-bias tool for randomised trials) in duplicate. The primary outcomes of interest were self-reported pain intensity on day 1 after discharge (standardised to 0-10 cm visual analogue scale) and vomiting up to 30 days. Pain intensity at further timepoints, pain interference, other adverse events, risk of dissatisfaction, and health-care reutilisation were also assessed. We did random-effects meta-analyses and appraised evidence certainty using the Grading of Recommendations, Assessment, Development, and Evaluations scoring system. The review was registered with PROSPERO (ID CRD42020153050). FINDINGS: 47 trials (n=6607 patients) were included. 30 (64%) trials involved elective minor procedures (63% dental procedures) and 17 (36%) trials involved procedures of moderate extent (47% orthopaedic and 29% general surgery procedures). Compared with opioid-free analgesia, opioid prescribing did not reduce pain on the first day after discharge (weighted mean difference 0·01cm, 95% CI -0·26 to 0·27; moderate certainty) or at other postoperative timepoints (moderate-to-very-low certainty). Opioid prescribing was associated with increased risk of vomiting (relative risk 4·50, 95% CI 1·93 to 10·51; high certainty) and other adverse events, including nausea, constipation, dizziness, and drowsiness (high-to-moderate certainty). Opioids did not affect other outcomes. INTERPRETATION: Findings from this meta-analysis support that opioid prescribing at surgical discharge does not reduce pain intensity but does increase adverse events. Evidence relied on trials focused on elective surgeries of minor and moderate extent, suggesting that clinicians can consider prescribing opioid-free analgesia in these surgical settings. Data were largely derived from low-quality trials, and none involved patients having major or major-complex procedures. Given these limitations, there is a great need to advance the quality and scope of research in this field. FUNDING: The Canadian Institutes of Health Research.

The association of alvimopan treatment with postoperative outcomes after abdominal surgery: A systematic review across different surgical procedures and contexts of perioperative care.

BACKGROUND: Alvimopan is a Food and Drug Administration-approved treatment to accelerate gastrointestinal recovery after abdominal surgery; however, benefits may vary across different procedures and contexts of care. The purpose of this study is to summarize the evidence regarding the effect of alvimopan on postoperative outcomes after abdominal surgery. METHODS: Major databases (Medline, Embase, Biosis, Cochrane, Web of Science, and Scopus) were searched for randomized controlled trials and nonrandomized studies comparing alvimopan versus control. Risk of bias was assessed using Cochrane's risk of bias tool 2.0 (for randomized controlled trials) and Risk of Bias in Nonrandomized Studies-of Intervention tool (for nonrandomized studies). Results were appraised descriptively as heterogeneity in reporting and risk of bias hindered meta-analysis. Quality of evidence across different surgical procedures and contexts of care (ie, open versus minimally invasive surgery, traditional care versus enhanced recovery pathway) was evaluated using Grading of Recommendations Assessment, Development, and Evaluation. RESULTS: Nine randomized controlled trials and 35 nonrandomized studies were identified. Evidence of low to moderate certainty supports that alvimopan reduces length of stay and improves gastrointestinal recovery after open bowel resection and open radical cystectomy. Limited evidence supports alvimopan for surgeries not listed in Food and Drug Administration labels (ie, total abdominal hysterectomy and retroperitoneal lymph node dissection). Similar effects were observed in traditional and enhanced recovery pathway settings, but enhanced recovery pathway elements varied across studies. There is very low certainty of evidence supporting alvimopan for patients undergoing minimally invasive surgery. CONCLUSION: Evidence supports that alvimopan improves outcomes after open bowel resection and open radical cystectomy. Benefits for patients undergoing minimally invasive surgery and treated in contemporary enhanced recovery pathway settings remain uncertain. These findings contribute important new knowledge to inform evidence-based alvimopan prescribing.

Opioid versus opioid-free analgesia after surgical discharge: protocol for a systematic review and meta-analysis.

INTRODUCTION: Excessive prescribing after surgery has contributed to a public health crisis of opioid addiction and overdose in North America. However, the value of prescribing opioids to manage postoperative pain after surgical discharge remains unclear. We propose a systematic review and meta-analysis to assess the extent to which opioid analgesia impact postoperative pain intensity and adverse events in comparison to opioid-free analgesia in patients discharged after surgery. METHODS AND ANALYSIS: Major electronic databases (MEDLINE, Embase, Cochrane Library, Scopus, AMED, BIOSIS, CINAHL and PsycINFO) will be searched for multi-dose randomised-trials examining the comparative effectiveness of opioid versus opioid-free analgesia after surgical discharge. Studies published from January 1990 to July 2019 will be targeted, with no language restrictions. The search will be re-run before manuscript submission to include most recent literature. We will consider studies involving patients undergoing minor and major surgery. Teams of reviewers will, independently and in duplicate, assess eligibility, extract data and evaluate risk of bias. Our main outcomes of interest are pain intensity and postoperative vomiting. Study results will be pooled using random effects models. When trials report outcomes for a common domain (eg, pain intensity) using different scales, we will convert effect sizes to a common standard metric (eg, Visual Analogue Scale). Minimally important clinical differences reported in previous literature will be considered when interpreting results. Subgroup analyses defined a priori will be conducted to explore heterogeneity. Risk of bias will be assessed according to the Cochrane Collaboration's Risk of Bias Tool 2.0. The quality of evidence for all outcomes will be evaluated using the GRADE rating system. ETHICS AND DISSEMINATION: Ethical approval is not required since this is a systematic review of published studies. Our results will be published in a peer-reviewed journal and presented at relevant conferences. Further knowledge dissemination will be sought via public and patient organisations focussed on pain and opioid-related harms.

Implementation and Effectiveness of Coaching for Surgeons in Practice - A Mixed Studies Systematic Review.

INTRODUCTION: Despite recent changes to medical education, surgical training remains largely based on the apprenticeship model. However, after completing training, there are few structured learning opportunities available for surgeons in practice to refine their skills or acquire new skills. Personalized observation with feedback is rarely a feature of traditional continuing medical education learning. Coaching has recently been proposed as a modality to meet these educational gaps; however, data are limited, and few coaching programs presently exist. The purpose of this study is to summarize the characteristics of coaching programs for surgeons in practice including participant satisfaction, program outcomes, and barriers to implementation, in the published literature. METHODS: A mixed studies systematic review was conducted according to PRISMA guidelines to identify all original studies describing or investigating coaching for practicing surgeons up to 06/2019. Quantitative analysis was used to summarize numerical data, and qualitative analysis using grounded theory methodology for descriptive data was used to summarize the results into themes across studies. RESULTS: After identification of articles, 27 were included in the final synthesis. Twenty-six articles described execution of a coaching program. Programs varied widely with 18/26 focusing on teaching new skills, and the remainder on refinement of skills. Thematic analysis identified 2 major data categories that guided deeper analysis: outcomes of and barriers to coaching. Of the 16 (62%) programs that reported outcomes of coaching, 42% to 100% of participants reported changes in clinical practice directly associated with coaching. Positive satisfaction after completion of a program was reported by 82% to 100% of participants. Reported barriers to participating in a coaching program emerged along 3 main themes: logistical constraints, surgical culture, and perceived lack of need. CONCLUSIONS: Coaching for surgeons in practice is highly rated by participants and often results in clinical practice changes, while cultural and logistical issues were identified as barriers to implementation. A better understanding of these factors is required to guide coaching program development and implementation.

Systematic review of microRNA biomarkers in acute coronary syndrome and stable coronary artery disease.

The aim of this systematic review was to assess dysregulated miRNA biomarkers in coronary artery disease (CAD). Dysregulated microRNA (miRNAs) have been shown to be linked to cardiovascular pathologies including CAD and may have utility as diagnostic and prognostic biomarkers. We compared miRNAs identified in acute coronary syndrome (ACS) compared with stable CAD and control populations. We conducted a systematic search of controlled vocabulary and free text terms related to ACS, stable CAD and miRNA in Biosis Previews (OvidSP), The Cochrane Library (Wiley), Embase (OvidSP), Global Health (OvidSP), Medline (PubMed and OvidSP), Web of Science (Clarivate Analytics), and ClinicalTrials.gov which yielded 7370 articles. Of these, 140 original articles were appropriate for data extraction. The most frequently reported miRNAs in any CAD (miR-1, miR-133a, miR-208a/b, and miR-499) are expressed abundantly in the heart and play crucial roles in cardiac physiology. In studies comparing ACS cases with stable CAD patients, miR-21, miR-208a/b, miR-133a/b, miR-30 family, miR-19, and miR-20 were most frequently reported to be dysregulated in ACS. While a number of miRNAs feature consistently across studies in their expression in both ACS and stable CAD, when compared with controls, certain miRNAs were reported as biomarkers specifically in ACS (miR-499, miR-1, miR-133a/b, and miR-208a/b) and stable CAD (miR-215, miR-487a, and miR-502). Thus, miR-21, miR-133, and miR-499 appear to have the most potential as biomarkers to differentiate the diagnosis of ACS from stable CAD, especially miR-499 which showed a correlation between the level of their concentration gradient and myocardial damage. Although these miRNAs are potential diagnostic biomarkers, these findings should be interpreted with caution as the majority of studies conducted predefined candidate-driven assessments of a limited number of miRNAs (PROSPERO registration: CRD42017079744).

Preventing opioid prescription after major surgery: a scoping review of opioid-free analgesia.

BACKGROUND: Excessive opioid prescribing after surgery has been recognised as a contributor to the current crisis of opioid addiction and overdose. Clinicians may potentially tackle this crisis by using opioid-free postoperative analgesia; however, the scientific literature addressing this approach is sparse and heterogeneous, thereby limiting robust conclusions. A scoping review was conducted to systematically map the extent, range, and nature of the literature addressing postoperative opioid-free analgesia. METHODS: Eight bibliographic databases were searched for studies addressing opioid-free analgesia after a major surgery. We extracted the study characteristics, including design, country, year, surgical procedure(s), and interventions. Results were organised thematically according to surgical specialty and targeted phase of recovery: in hospital (early recovery, ≤24 h after operation; intermediate recovery, >24 h) and post-discharge (late recovery). Reporting was according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement for scoping reviews. RESULTS: We identified 424 studies addressing postoperative opioid-free analgesia. The number of studies conducted in countries where the opioid crisis is primarily focused was remarkably low (USA, n=11 [3%]; Canada, n=5 [1%]). Many RCTs compared opioid-free vs opioid analgesia during hospital stay (n=117), but few targeted analgesia post-discharge (n=8). Studies were predominantly focused on procedures in orthopaedic, general, and gynaecological/obstetric surgery. Limited attention has been directed towards non-pharmacological pain interventions. We did not identify knowledge synthesis studies (i.e. systematic reviews and meta-analyses) focused on the comparative effectiveness of opioid-free vs opioid analgesia. CONCLUSIONS: Opioids remain a mainstay analgesic for managing pain after surgery, but alternative analgesia strategies should not be overlooked. This scoping review indicates numerous opportunities for future research targeting opioid-free postoperative analgesia. REVIEW REGISTRATION: http://www.researchregistry.com; ID: reviewregistry576.

Simulation platforms to assess laparoscopic suturing skills: a scoping review.

BACKGROUND: Laparoscopic suturing (LS) has become a common technique used in a variety of advanced laparoscopic procedures. However, LS is a challenging skill to master, and many trainees may not be competent in performing LS at the end of their training. The purpose of this review is to identify simulation platforms available for assessment of LS skills, and determine the characteristics of the platforms and the LS skills that are targeted. METHODS: A scoping review was conducted between January 1997 and October 2018 for full-text articles. The search was done in various databases. Only articles written in English or French were included. Additional studies were identified through reference lists. The search terms included "laparoscopic suturing" and "clinical competence." RESULTS: Sixty-two studies were selected. The majority of the simulation platforms were box trainers with inanimate tissue, and targeted basic suturing and intracorporeal knot-tying techniques. Most of the validation came from internal structure (rater reliability) and relationship to other variables (compare training levels/case experience, and various metrics). Consequences were not addressed in any of the studies. CONCLUSION: We identified many types of simulation platforms that were used for assessing LS skills, with most being for assessment of basic skills. Platforms assessing the competence of trainees for advanced LS skills were limited. Therefore, future research should focus on development of LS tasks that better reflect the needs of the trainees.

Incidence and predictors of postoperative ileus after loop ileostomy closure: a systematic review and meta-analysis.

INTRODUCTION: Postoperative ileus (POI) is regarded as the most clinically significant morbidity following loop ileostomy closure; however, its incidence remains poorly understood. Our objective was therefore to determine the pooled incidence of POI after loop ileostomy closure and identify risk factors associated with its development. METHODS: We systematically searched MEDLINE (via Ovid and PubMed), Embase, the Cochrane Library, Biosis Previews, and Scopus to identify studies reporting the incidence of POI in patients who underwent loop ileostomy closure. Two independent reviewers extracted data and appraised study quality. Cumulative incidence proportions were pooled across studies using a random-effects meta-analytic model. RESULTS: Sixty-seven studies, including 9528 patients, met our inclusion criteria. The pooled estimate of POI was 8.0% (95% CI 6.9-9.3%; I2 = 74%). The estimated incidence varied by POI definition: studies with a robust definition of POI (n = 8) demonstrated the highest estimate of POI (12.4%, 95% CI 9.2-16.5%; I2 = 79%) while studies that did not report an explicit POI definition (n = 38) demonstrated the lowest estimate (6.7%, 95% CI 5.3-8.3%; I2 = 61%). Small bowel anastomosis technique (hand-sewn) and interval time from ileostomy creation to closure (longer time) were the factors most commonly associated with POI after loop ileostomy closure. However, most comparative studies were not powered to examine risk factors for POI. CONCLUSIONS: POI is an important complication after loop ileostomy closure, and its incidence is dependent on its definition. More research aimed at studying this complication is required to better understand risk factors for POI after loop ileostomy closure.

Preoperative Exercise Rehabilitation in Cardiac and Vascular Interventions.

BACKGROUND: Exercise-based interventions have become part of the standard of care in rehabilitation programs for cardiovascular risk reduction and the promotion of a healthy lifestyle. The systematic review describes the current state of knowledge of the effects of preoperative exercise training (prehabilitation) on perioperative clinical outcomes in patients undergoing cardiac and vascular interventions. METHODS: Studies were systematically searched within 14 databases from inception to October 2016. Only studies that assessed a preoperative exercise program in adult patients undergoing cardiac or vascular interventions with clinical or patient-centered endpoints were included in the review. Two independent reviewers selected studies for inclusion, extracted data, and assessed quality using Cochrane Collaboration's tool for RCTs11111111111111111 and ROBINS-I tool for nonrandomized studies. RESULTS: Nine studies met our inclusion criteria and were stratified for qualitative analyses by cardiac (n = 7) and vascular (n = 2) procedures. Prehabilitation was associated with decreased length of stay, reduced postoperative complications, improved objective physical functioning, and improved subjective quality of life (SF-36 physical and mental health domains) measures in patients undergoing cardiac and vascular procedures. Given the amount of heterogeneity that was present in the designs, populations, and comparators among the included studies, we were unable to statistically pool data across trials. CONCLUSIONS: Our qualitative findings suggest that prehabilitation may improve clinical outcomes, physical performance, and health-related quality-of-life measures in patients undergoing cardiac and vascular surgery procedures.

Antipsychotics for the treatment of sympathomimetic toxicity: A systematic review.

OBJECTIVE: Benzodiazepines are often recommended first-line for management of cocaine and amphetamine toxicity while antipsychotic treatment is discouraged due to the potential for lowering seizure threshold, prolonging the QT interval, and decreasing heat dissipation. We performed a systematic review including animal and human studies to elucidate the efficacy and safety of antipsychotics in managing sympathomimetic toxicity specifically evaluating the effect of treatment on mortality, seizures, hyperthermia, and cardiovascular effects. METHODS: We searched MEDLINE, Embase, BIOSIS Previews, Web of Science, Scopus, CENTRAL and gray literature from inception to 31 May 2017 to answer: Can antipsychotics be used safely and effectively to treat cocaine or amphetamine toxicity? Citations were screened by title and abstract. Additional citations were identified with citation tracking. Data were extracted from full-texts. RESULTS: 6539 citations were identified; 250 full-text articles were assessed. Citation tracking identified 2336 citations; 155 full texts were reviewed. Seventy-three papers were included in this review. In 96 subjects with cocaine toxicity treated with an antipsychotic, there were three deaths, two cardiac arrests, two seizures, and one episode of hyperthermia. In 330 subjects with amphetamine toxicity treated with an antipsychotic, there were two episodes of coma and QT prolongation and one episode of each: hypotension, NMS, cardiac arrest, and death. CONCLUSION: This systematic review represents an exhaustive compilation of the available evidence. There is neither a clear benefit of antipsychotics over benzodiazepines nor a definitive signal of harm noted. We encourage clinicians to adapt treatment based on specific circumstances and characteristics of their individual patients.

Assessment of surgical performance of laparoscopic benign hiatal surgery: a systematic review.

BACKGROUND: Operative skills correlate with patient outcomes, yet at the completion of training or after learning a new procedure, these skills are rarely formally evaluated. There is interest in the use of summative video assessment of laparoscopic benign foregut and hiatal surgery (LFS). If this is to be used to determine competency, it must meet the robust criteria established for high-stakes assessments. The purpose of this review is to identify tools that have been used to assess performance of LFS and evaluate the available validity evidence for each instrument. METHODS: A systematic search was conducted up to July 2017. Eligible studies reported data on tools used to assess performance in the operating room during LFS. Two independent reviewers considered 1084 citations for eligibility. The characteristics and testing conditions of each assessment tool were recorded. Validity evidence was evaluated using five sources of validity (content, response process, internal structure, relationship to other variables, and consequences). RESULTS: There were six separate tools identified. Two tools were generic to laparoscopy, and four were specific to LFS [two specific to Nissen fundoplication (NF), one heller myotomy (HM), and one paraesophageal hernia repair (PEH)]. Overall, only one assessment was supported by moderate evidence while the others had limited or unknown evidence. Validity evidence was based mainly on internal structure (all tools reporting reliability and item analysis) and content (two studies referencing previous papers for tool development in the context of clinical assessment, and four listing items without specifying the development procedures). There was little or no evidence supporting test response process (one study reporting rater training), relationship to other variables (two comparing scores in subjects with different clinical experience), and consequences (no studies). Two tools were identified to have evidence for video assessment, specific to NF. CONCLUSION: There is limited evidence supporting the validity of assessment tools for laparoscopic foregut surgery. This precludes their use for summative video-based assessment to verify competency. Further research is needed to develop an assessment tool designed for this purpose.

Scoping review of frailty in vascular surgery.

OBJECTIVE: This review sought to describe the current state of knowledge of the impact of frailty on perioperative clinical outcomes in patients undergoing vascular interventions. METHODS: A scoping review of the literature from both PubMed and Ovid Embase databases was conducted to identify relevant English- and French-language articles published from inception to May 31, 2018. Patients undergoing vascular surgery interventions were included. RESULTS: Twenty-three studies have addressed the prevalence or prognostic impact of frailty in patients undergoing vascular surgery procedures. The prevalence of frailty ranged from 20% to 60%, and notably 14 different frailty assessments were used in these studies. Frailty was associated with increased comorbid status, prolonged length of stay, discharge to assisted living facility, loss of independence, postoperative morbidity, and all-cause mortality. CONCLUSIONS: There are a variety of heterogeneous tools to measure frailty in patients undergoing vascular surgery interventions. The prevalence of frailty varies by the scale used to measure it, as does its predictive value. Clinicians and surgeons should be sensitized to the importance of assessing frailty preoperatively in older adults undergoing vascular surgery and using it to assist in the decision-making process and allocation of surgical resources.

Factors contributing to successful trauma registry implementation in low- and middle-income countries: A systematic review.

BACKGROUND: Trauma registries (TR) provide invaluable data, informing resource allocation and quality improvement. The purpose of this systematic review was to identify factors promoting and inhibiting successful TR implementation in low- and middle-income countries (LMICs). METHODS: The protocol was registered a priori (CRD42017058586). With librarian oversight, a peer-reviewed search strategy was developed. Adhering to PRISMA guidelines, two independent reviewers performed first-screen and full-text screening. Studies describing implementation of a TR in LMICs or reviewed the experience of registry users/implementers were included. Extracted data, focusing on publication, institution, registry and data factors, was summarized using descriptive statistics and subjected to thematic qualitative analysis. RESULTS: Out of 3842 screened references, 40 articles were included for analysis. Most registries were paper-based, implemented in single publicly-funded institutions within LMICs, benefited from funding, and were run by untrained house-staff with other clinical responsibilities. Constituent variables, injury scoring, outcome assessment, and quality assurance practices were very diverse. Principal obstacles to successful implementation were lack of funding, significant missing data, and insufficient resources. CONCLUSIONS: This work may contribute to the planning of future efforts towards TR implementation in LMICs, where better injury data has the potential to alleviate the morbidity and mortality associated with trauma through advocacy and quality-improvement.

Long-Term Cognitive Impairment After Preeclampsia: A Systematic Review and Meta-analysis.

OBJECTIVE: To systematically review and summarize studies investigating an association between a history of preeclampsia and cognitive function later in life. DATA SOURCES: Studies published before August 2017 were identified without any language restriction or study design limits through electronic searches of 10 main databases including MEDLINE and ClinicalTrials.gov. METHODS OF STUDY SELECTION: We considered all observational studies that included preeclampsia as a clearly defined prespecified risk factor and that examined a cognition-related outcome measure including validated cognitive tests, magnetic resonance brain imaging, or a clinical diagnosis of dementia. Study quality was assessed using the New-Castle Ottawa scale. All review stages were conducted independently by two reviewers, and disagreement was resolved by a third reviewer. Where possible, data were pooled using a random-effects model. TABULATION, INTEGRATION, AND RESULTS: Of 3,126 potentially relevant studies, 13 were included in our review (1,314 women with prior preeclampsia and 289,080 women with prior normotensive pregnancy); median time since pregnancy was 6 years. A higher number of self-reported deficits in perception, memory, and motor functioning on the Cognitive Failure Questionnaire was reported in women with vs without prior preeclamptic pregnancies (Cognitive Failure Questionnaire mean total score 41.5 vs 36.8 out of 100, weighted mean difference of -5.1 points [-9.4 to -0.8]). Our meta-analysis did not reveal significant differences in studies assessing attention (Digit Symbol Substitution or Coding); however, women with preeclampsia performed worse on one of two meta-analyzed tests assessing memory (Letter Number Sequencing mean total score: 10.6 vs 10.1 out of 21, weighted mean difference of 0.63 points 0.06-1.2). Pooling of cognitive outcome measures for studies assessing brain imaging or a clinical diagnosis of dementia were limited by differences in reporting and marked heterogeneity between studies. CONCLUSION: Although preeclampsia is associated with subjective cognitive symptoms, our systematic review did not demonstrate clear evidence of impairment on standard neurocognitive tests. There is a paucity of high-quality studies assessing cognitive outcomes after preeclampsia.

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.

Comparison of Endoscopic Dysplasia Detection Techniques in Patients With Ulcerative Colitis: A Systematic Review and Network Meta-analysis.

Background: We assessed the comparative efficacy of different dysplasia detection techniques in patients with ulcerative colitis (UC) through a network meta-analysis and rated the quality of evidence using GRADE approach. Methods: Through a systematic literature review of multiple databases through June 30, 2017, we identified parallel-group randomized controlled trials (RCTs) in adults with long-standing UC undergoing surveillance colonoscopy with standard definition-white light endoscopy (SD-WLE), high-definition WLE (HD-WLE), narrow band imaging (NBI), or dye-based chromoendoscopy. The primary outcome was the total number of dysplastic lesions. Pairwise and network meta-analysis was performed; ranking was assessed using surface under the cumulative ranking (SUCRA) probabilities. Results: Based on 8 parallel-group RCTs (924 patients), low-quality evidence supports chromoendoscopy over SD-WLE (odds ratio [OR], 2.37; 95% credible interval [CrI], 0.81-6.94) for any dysplasia detection, whereas very low-quality evidence supports using HD-WLE or NBI over SD-WLE (HD-WLE [vs SD-WLE]: OR, 1.21; 95% CrI, 0.30-4.85; NBI: OR, 1.68; 95% CrI, 0.54-5.22). Very low-quality evidence from indirect comparative analysis supports the use of chromoendoscopy over HD-WLE (OR, 1.96; 95% CrI, 0.72-5.34) or NBI (OR, 1.41; 95% CrI, 0.70-2.84) for any dysplasia detection. The number of patients with advanced neoplasia was very small, precluding meaningful analysis. Conclusions: Although we did not find any single technique to be superior, chromoendoscopy is probably more effective than SD-WLE for detecting any dysplasia, and there is low confidence in estimates supporting its use over HD-WLE or NBI. There is very low-quality evidence to inform the comparative efficacy of these interventions in detecting advanced neoplasia or preventing future colorectal cancer. Pragmatic, parallel-group RCTs with longitudinal follow-up are warranted to inform optimal dysplasia surveillance techniques. 10.1093/ibd/izy188_video1izy188.video15789702674001.

Enrollment and reporting practices in pediatric general surgical randomized clinical trials: A systematic review and observational analysis.

BACKGROUND: Pediatric surgical randomized clinical trials (RCTs) are labor-intensive and costly. This systematic review investigated patient accrual and estimates of study duration in RCTs by interrogating enrollment and registration practices. METHODS: We performed a peer-review search of multiple databases from 2000 to 2016 evaluating RCTs salient to the field with inclusion mandated that a self-identified pediatric surgeon be listed as an author. Trial registries were also searched. RCTs were appraised, and predictors of success were evaluated using multivariate logistic regression, with success defined as achievement of recruitment objectives. RESULTS: After screening, 137 RCTs were analyzed. Mean Jadad score was 1.80 (median=2). CONSORT scores ranged between 17% and 97% (median=58%). Sixty-seven studies described sample-size determination, 49 reported projected enrollment, and 26 were successful. Among 26 registered RCTs, 15 disclosed their expected completion date, which was achieved by 8. On average, protocols underwent 3.42 iterations. 9% of trials were terminated before completion, most commonly owing to poor recruitment. Trial registration and urgent cases significantly predicted success on multivariable analysis (p<0.05). CONCLUSION: Overall quality of reporting in pediatric surgical trials is poor. Sample-size calculation and patient accrual are frequently poorly performed or underestimated, resulting in trial overrun and/or premature termination. These data may help inform subsequent study design and facilitate successful completion. LEVEL OF EVIDENCE: Level III-Systematic Review and Observational (Case-Control) Analysis.