Dietary counseling plus omega-3 supplementation in the treatment of generalized anxiety disorder: results of a randomized wait-list controlled pilot trial (the 'EASe-GAD Trial').

OBJECTIVES: Clinical evidence suggests that nutrition interventions can significantly improve symptoms of major depressive disorder; however, the effect on clinical anxiety symptoms in individuals with anxiety disorders has not been studied. The primary objective of the present study was to assess the feasibility and acceptability of a nutrition intervention. The secondary objectives included assessing changes in anxiety symptom severity, diet quality, self-efficacy, mindful eating, quality of life, and biomarkers. METHODS: This study was a randomized, wait-list controlled pilot trial delivering a 12-week, biweekly dietary counseling intervention and omega-3 supplementation to 50 adult women with generalized anxiety disorder. Questionnaires and blood work were completed at baseline, after the waiting period, and after the intervention. RESULTS: 443 individuals expressed interest within eight months; 50 met the criteria for enrollment. The mean number of sessions attended was 6.4. Final questionnaires were completed by 46 participants. Eighty-four percent of participants strongly agreed with the statement 'My experience during this study was positive'. The mean anxiety symptom severity score in the intervention group was 26.2 (95% CI 22.94-29.48) at baseline and 11.0 (95% CI 8.05-13.87) at week 12. The mean diet quality score was 7.2 (95% CI 6.32-8.10) and 10.5 (95% CI 9.55-11.49) at baseline and week 12, respectively. Among the waitlist participants, the mean baseline anxiety score was 29.3 (95% CI 24.73-33.91) and 26.8 (95% CI 22.09-31.56) at week 12. DISCUSSION: This study was feasible and acceptable. Participation in the intervention was associated with a decrease in anxiety symptoms. These findings lay the foundation for large-scale studies. Trial registration: ClinicalTrials.gov NCT05573672.

Diagnostic Accuracy of Pre-operative Percutaneous Synovial Biopsy and Aspirate Compared with Open Biopsy for Prosthetic Shoulder Infections.

BACKGROUND: Shoulder arthroplasty revision is associated with a high prevalence of prosthetic infection, and diagnosis remains difficult. The primary aim of the study was to determine the diagnostic accuracy of percutaneous synovial biopsy (PSB) and joint aspiration compared with open culture results in detecting infection in revision shoulder arthroplasty. The second aim was to determine whether biopsy location within the shoulder was associated with culture status. METHODS: This was a multicenter prospective cohort study involving four sites and 69 patients undergoing revision shoulder arthroplasty. The cohort was 57% female with a mean age of 64 years. Preoperative fluoroscopic-guided PSB's and aspirates were carried out by a musculoskeletal radiologist prior to revision shoulder arthroplasty. The original prostheses consisted of hemiarthroplasties, total shoulder arthroplasties (TSA), resurfacing TSA, reverse shoulder arthroplasties (RSA), and antibiotic spacers. Six synovial tissue biopsies from separate regions in the shoulder were obtained both preoperatively and intra-operatively. The shoulder joint was aspirated, and synovial fluid collected, if available. Infection was considered positive in the setting of two or more matching positive cultures. The PSB cultures were considered "true positive" if the PSB cultures matched the open biopsy cultures. RESULTS: Nineteen percent had positive infection based on PSB and 23% had confirmed culture positive infections based on intra-operative biopsy. The diagnostic accuracy of PSB compared with open biopsy was as follows: sensitivity 0.37 (95% CI 0.13-0.61), specificity 0.81 (95% CI 0.7-0.91), positive predictive value 0.37 (95% CI 0.13 - 0.61), negative predictive value 0.81 (95% CI 0.70-0.91), positive likelihood ratio 1.98 and negative likelihood ratio 0.77. Of the 71 patients, aspiration yielded synovial fluid in 33 patients. Preoperative aspirates detected no infections confirmed positive by open biopsy and correctly identified 81% of absent infections. The diagnostic accuracy of aspirates compared with open biopsy was as follows: sensitivity 0%, specificity 0.81 (95% CI 0.66-0.96), positive predictive value 0%, negative predictive value 0.78 (95% CI 0.63-0.93). Biopsy location within the shoulder was not associated with infection status. DISCUSSION: Preoperative aspiration detected none of the infections proven positive via open biopsy. Although PSB was superior to synovial fluid aspirate, poor likelihood ratios suggests that PSB is not useful as an isolated test in the preoperative workup of the potentially infected patient. Biopsy location was not associated with culture status suggesting that the capsule is uniformly infected, and the location of tissue biopsies does not appear to matter.

Prevalence of anemia and association with outcome in joint arthroplasty - is there a difference between primary and revision cases?

PURPOSE: Anemia has been shown to be a modifiable pre-operative, patient factor associated with outcome following arthroplasty. The aims of this retrospective study were to (1) ascertain the prevalence of preoperative anemia in patients undergoing primary and revision hip and knee arthroplasty at a tertiary referral center and (2) to test the association with outcome and whether it differs between primary and revision cases. METHODS: All hip and knee primary and revision arthroplasties performed at a Canadian academic, tertiary-care, arthroplasty center between 2012 and 2017 were included in this study. The study group consisted of 5944 patients, of which 5251 were primary Total Hip and Knee Arthroplasties or Hip Resurfacings and 693 were revision arthroplasties (65% hip revisions/35% knee revisions). Anemia was classified as per WHO definition (hemoglobin < 130 g/L for men and < 120 g/L for women). All anemic patients were grouped into mild, moderate or severe anemia. Length-of-stay, perioperative transfusion-rate, 90-day readmission, overall complication rate and reoperation rates were recorded. The effect of preoperative anemia and the effect of severity of the anemia was evaluated through multivariable regression analysis controlling for relevant covariates. RESULTS: Preoperatively, 15% (786/5251) of the primary patients and 47% (322/693) of the revision arthroplasty patients were anemic preoperatively. Anemic revision patients were 3.1 times more likely (95% CI: 1.47-6.33) to obtain blood transfusions during the hospital stay, compared to a 4.9 times higher risk in primary patients. The odds ratio to sustain any postoperative complication if anemic was 1.5 times higher (95% CI: 0.73-3.16) in revision patients and 1.7 in primary cases. In addition, the 90-day readmission rate among both groups was 1.6 times higher in anemic patients. Furthermore, anemic revision patients had a 5.3 days longer length of stay (95% CI: 2.63-7.91), compared to only 1 additional day in anemic primary patients (95% CI: 0.69-1.34). CONCLUSION: In this study cohort, the prevalence of anemia in patients awaiting revision arthroplasty was 3 times higher (46.6%) than in primary arthroplasty patients (18.7%). Preoperative anemia was associated with similarly, inferior outcomes in both groups. To reduce postoperative complications and the "burden" associated with anemia, these findings strongly recommend optimizing the preoperative hemoglobin in all arthroplasty patients. However, revision patients are affected more frequently, and particular attention must therefore be taken to this growing group in the future. LEVEL OF EVIDENCE: Level III.

Association Between Length of Storage of Transfused Packed RBC Units and Outcome of Surgical Critically Ill Adults: A Subgroup Analysis of the Age of Blood Evaluation Randomized Trial.

OBJECTIVES: The Age of Blood Evaluation (ABLE) study reported no clinical benefit in fresher compared with standard delivery RBC units (length of storage: 6.9 ± 4.1 vs 22.0 ± 8.4 d, respectively). Perioperative patients are often anemic, at risk of blood loss, and more exposed to RBC transfusions. We address the question whether fresh RBC units are safer than standard delivery RBC units in perioperative ICU patients. DESIGN: Subgroup analysis of surgical nontrauma adults enrolled in the ABLE randomized controlled trial. SETTING: ICUs. PATIENTS: Three hundred twenty surgical patients among the 2,510 ICU adults recruited in the ABLE study who had a request for a first RBC transfusion in the first week in ICU stay and an anticipated length of mechanical ventilation greater than or equal to 48 hours. We included perioperative patients but excluded elective cardiac surgery and trauma. INTERVENTIONS: Surgical participants were allocated to receive either RBC units stored less than or equal to 7 days or standard issue RBC. MEASUREMENTS AND MAIN RESULTS: The primary outcome was 90-day all-cause mortality. One hundred seventy-two perioperative patients were allocated to the fresh and 148 to the standard group. Baseline data were similar. The length of storage was 7.2 ± 6.4 in fresh and 20.6 ± 8.4 days in standard group ( p < 0.0001). The 90-day mortality was 29.7% and 28.4%, respectively (absolute risk difference: 0.01; 95% CI -0.09 to 0.11; p = 0.803). No significant differences were observed for all secondary outcomes, including 6-month mortality, even after adjustment for age, country, and Acute Physiology and Chronic Health Evaluation score. CONCLUSIONS: There was no evidence that fresh red cells improved outcomes as compared to standard issue red cells in critically ill surgical patients, consistent with other patients enrolled in the ABLE trial.

A cross-sectional study of the interrelationship between burnout, empathy and resilience in academic physicians.

Burnout is a growing concern, with significant negative consequences for physicians and patient care. Burnout is negatively associated with physician empathy, while resilience may be a protective factor against the development of burnout but few studies have examined all three constructs in the same cohort. Understanding the associations between these constructs could aid in the development of interventions for physicians experiencing burnout and improve the delivery of compassionate care. We conducted a cross-sectional survey to determine levels of burnout, empathy and resilience in a sample of academic physicians and investigate the relationships between these variables. Validated scales were administered online to measure burnout (Maslach Burnout Inventory - Human Services Survey, MBI-HSS), empathy (Jefferson Scale of Empathy - Physicians/Health Professions Version, JSE) and resilience (Connor-Davidson Resilience Scale, CD-RISC). Descriptive statistics, correlation coefficients, and group comparisons were examined. Eighty-three physicians completed the JSE and CD-RISC, while a subset of 49 physicians also completed the MBI-HSS. Response rates were 31.9% and 18.8%, respectively. High burnout was reported by 49% of the sample. Physicians with high burnout reported lower levels of resilience than those who were not burnt-out. No differences in levels of empathy were observed between these two groups. Older physicians (>45 years) reported higher resilience scores than younger physicians. Resilience and empathy were significantly positively correlated. The reported rate of physician burnout in this sample of academic physicians is concerning, with burnout associated with lower levels of resilience. Further research is required to explore the relationship between physician age and resilience, the impact of resilience-building interventions on burnout and empathy in physicians, and how modifying these variables influences the delivery of compassionate care for patients.

Tumor Necrosis Factor Inhibitors May Have Limited Efficacy for Complex Perianal Fistulas Without Luminal Crohn's Disease.

BACKGROUND: Complex perianal fistulas occurring in the absence of luminal inflammation (isolated perianal disease, IPD) may represent a specific phenotype of Crohn's disease (CD). AIM: We assessed the effectiveness of tumor necrosis factor (TNF)-antagonists in patients with IPD compared to those with perianal CD (PCD) with luminal inflammation. METHODS: Patients were identified through our institutional radiology database and were classified as PCD or IPD based on the presence or absence of luminal inflammation by ileocolonoscopy and abdominal enterography. Consecutive adults (> 17 years) with recurrent IPD who were treated with TNF antagonists were matched by age and gender to patients with complex PCD (1:2 ratio). Fistula remission was defined as an absence of fistula drainage. Surgery-free survival was assessed by Cox proportional hazard models. RESULTS: Twenty-two patients with IPD treated with a TNF antagonist were compared with 44 matched patients with PCD. A similar proportion of patients with IPD and PCD were treated with concomitant immunomodulators (55% vs. 66%) and underwent examinations under anesthesia prior to therapy (36% vs. 46%). Fistula remission at 3, 6, and 12 months was lower for the IPD cohort: 9.5% versus 34%; 19% versus 39%; and 19% versus 43%. Surgical intervention after initiating anti-TNF therapy was more common for patients with IPD (HR 3.99: 95% CI, 1.62-9.83; p = 0.0026). CONCLUSIONS: Fewer patients with IPD achieved fistula remission, and more required surgical intervention after anti-TNF therapy, suggesting that TNF antagonists may not be as effective in these patients.

Does omitting teratospermia as a selection criterion for ICSI change pregnancy rates?

PURPOSE: There is controversy whether teratospermia is associated with poorer IVF outcomes and if ICSI may overcome this deficit. The debate likely lies in study heterogeneity, poor adjustment for confounders, and inter-observer variation in sperm morphology assessment. Given the current literature, a shift in practice was implemented at our center in February 2017, whereby teratospermia was no longer a criterion for ICSI. We hypothesized that, despite decreasing ICSI rates, we would see no change in ART outcomes. METHODS: A retrospective study was performed including 1821 couples undergoing IVF/ICSI at a single center from January 2016 to December 2018, divided into cohorts before and after the practice change. The primary outcome of clinical pregnancy and secondary outcomes of fertilization, fertilization failure, good quality blastocyst formation, embryo utilization, positive hCG, and miscarriage rates was compared, adjusting for potential confounders. Subgroup analysis was performed evaluating teratospermia as the only reason for a male factor infertility diagnosis. RESULTS: Despite a decrease in ICSI rate of 30.3%, we found no significant difference in clinical intrauterine pregnancy rate, with an adjusted relative risk of 0.93 (0.81, 1.07, P = 0.3008). There were no significant differences in other secondary outcomes after multivariate adjustment. Subgroup analysis for those with male factor infertility due to teratospermia showed no difference in outcomes. CONCLUSION: This study concurs with the recent data suggesting that employing ICSI solely for teratospermia is unnecessary. This may allow clinics to decrease ICSI rates without sacrificing success rates, leading to lower cost and risk associated with treatment.

Effect of age of transfused red blood cells on neurologic outcome following traumatic brain injury (ABLE-tbi Study): a nested study of the Age of Blood Evaluation (ABLE) trial.

BACKGROUND: Anemia is common in critically ill patients with traumatic brain injury, and often requires red blood cell transfusion. Studies suggest that prolonged storage causes lesions of the red blood cells, including a decreased ability to carry oxygen. Considering the susceptibility of the brain to hypoxemia, victims of traumatic brain injury may thus be more vulnerable to exposure to older red blood cells. METHODS: Our study aimed to ascertain whether the administration of fresh red blood cells (seven days or less) results in a better neurologic outcome compared with standard red blood cells in critically ill patients with traumatic brain injury requiring transfusion. The Age of Blood Evaluation in traumatic brain injury (ABLE-tbi) study was a nested study within the ABLE study (ISRCTN44878718). Our primary outcome was the extended Glasgow Outcome Scale (GOSe) at six months. RESULTS: In the ABLE study, 217 subjects suffered a traumatic brain injury: 110 in the fresh group, and 107 in the standard group. In the fresh group, 68 (73.1%) of the patients had an unfavourable neurologic outcome (GOSe ≤ 4) compared with 60 (64.5%) in the standard group (P = 0.21). Using a sliding dichotomy approach, we observed no overall effect of fresh red blood cells on neurologic outcome (odds ratio [OR], 1.34; 95% confidence interval [CI], 0.72 to 2.50; P = 0.35) but observed differences across prognostic bands with a decreased odds of unfavourable outcome in patients with the best prognosis at baseline (OR, 0.33; 95% CI, 0.11 to 0.96; P = 0.04) but an increased odds in those with intermediate and worst baseline prognosis (OR, 5.88; 95% CI,1.66 to 20.81; P = 0.006; and OR, 1.67; 95% CI, 0.53 to 5.30; P = 0.38, respectively). CONCLUSION: Overall, transfusion of fresh red blood cells was not associated with a better neurologic outcome at six months in critically ill patients with traumatic brain injury. Nevertheless, we cannot exclude a differential effect according to the patient baseline prognosis. TRIAL REGISTRATION: ABLE study (ISRCTN44878718); registered 22 August, 2008.

Age of transfused blood in critically ill adults.

BACKGROUND: Fresh red cells may improve outcomes in critically ill patients by enhancing oxygen delivery while minimizing the risks of toxic effects from cellular changes and the accumulation of bioactive materials in blood components during prolonged storage. METHODS: In this multicenter, randomized, blinded trial, we assigned critically ill adults to receive either red cells that had been stored for less than 8 days or standard-issue red cells (the oldest compatible units available in the blood bank). The primary outcome measure was 90-day mortality. RESULTS: Between March 2009 and May 2014, at 64 centers in Canada and Europe, 1211 patients were assigned to receive fresh red cells (fresh-blood group) and 1219 patients were assigned to receive standard-issue red cells (standard-blood group). Red cells were stored a mean (±SD) of 6.1±4.9 days in the fresh-blood group as compared with 22.0±8.4 days in the standard-blood group (P<0.001). At 90 days, 448 patients (37.0%) in the fresh-blood group and 430 patients (35.3%) in the standard-blood group had died (absolute risk difference, 1.7 percentage points; 95% confidence interval [CI], -2.1 to 5.5). In the survival analysis, the hazard ratio for death in the fresh-blood group, as compared with the standard-blood group, was 1.1 (95% CI, 0.9 to 1.2; P=0.38). There were no significant between-group differences in any of the secondary outcomes (major illnesses; duration of respiratory, hemodynamic, or renal support; length of stay in the hospital; and transfusion reactions) or in the subgroup analyses. CONCLUSIONS: Transfusion of fresh red cells, as compared with standard-issue red cells, did not decrease the 90-day mortality among critically ill adults. (Funded by the Canadian Institutes of Health Research and others; Current Controlled Trials number, ISRCTN44878718.).

Age of transfused blood in critically ill adult trauma patients: a prespecified nested analysis of the Age of Blood Evaluation randomized trial.

BACKGROUND: Blood transfusion is common in the resuscitation of patients with traumatic injury. However, the clinical impact of the length of storage of transfused blood is unclear in this population. STUDY DESIGN AND METHODS: We undertook a prespecified nested analysis of 372 trauma victims of the 2510 critically ill patients from 64 centers treated as part of the Age of Blood Evaluation (ABLE) randomized controlled trial. Patients were randomized according to their trauma status to receive either a transfusion of fresh blood stored not more than 7 days or standard-issue blood. Our primary outcome was 90-day all-cause mortality. RESULTS: Overall, 186 trauma patients received fresh blood and 186 received standard-issue blood. Adherence to transfusion protocol was 94% (915/971) for all fresh blood transfused and 100% (753/753) for all standard-issue blood transfused. Mean ± SD blood storage duration was 5.6 ± 3.8 days in the fresh group and 22.7 ± 8.4 days in the standard-issue group (p < 0.001). Ninety-day mortality in the fresh group was 21% (38/185), compared to 16% (29/184) in the standard-issue group, with an unadjusted absolute risk difference of 5% (95% confidence interval [CI], -3.1 to 12.6) and an adjusted absolute risk difference of 2% (95% CI, -3.5 to 6.8). CONCLUSION: In critically ill trauma patients, transfusion of fresh blood did not decrease 90-day mortality or secondary outcomes, a finding similar to the overall population of the ABLE trial.

Clinical research in surgical oncology: an analysis of ClinicalTrials.gov.

BACKGROUND: The objective of this study was to provide a descriptive analysis of registered clinical trials in surgical oncology at ClinicalTrials.gov. METHODS: Data was extracted from ClinicalTrials.gov using the following search engine criteria: "Cancer" as Condition, "Surgery OR Operation OR Resection" as Intervention, and Non-Industry sponsored. The search was limited to Canada and the United States and included trials registered from January 1, 2001 to January 1, 2011. RESULTS: Of 9,961 oncology trials, 1,049 (10.5%) included any type of surgical intervention. Of these trials, 125 (11.9%, 1.3% of all oncology trials) assessed a surgical variable, 773 (73.7%) assessed adjuvant/neoadjuvant therapies, and 151 (14.4%) were observational studies. Of the trials assessing adjuvant therapies, systemic treatment (362 trials, 46.8%) and multimodal therapy (129 trials, 16.7%) comprised a large focus. Of the 125 trials where surgery was the intervention, 59 trials (47.2%) focused on surgical techniques or devices, 45 trials (36.0%) studied invasive diagnostic methods, and 21 trials (16.8%) evaluated surgery versus no surgery. The majority of the 125 trials were nonrandomized (72, 57.6%). CONCLUSIONS: The number of registered surgical oncology trials is small in comparison to oncology trials as a whole. Clinical trials specifically designed to assess surgical interventions are vastly outnumbered by trials focusing on adjuvant therapies. Randomized surgical oncology trials account for <1% of all registered cancer trials. Barriers to the design and implementation of randomized trials in surgical oncology need to be clarified in order to facilitate higher-level evidence in surgical decision-making.

Healing rates and subscapularis fatty infiltration after lesser tuberosity osteotomy versus subscapularis peel for exposure during shoulder arthroplasty.

BACKGROUND: Controversy exists regarding the optimal technique of subscapularis mobilization during shoulder arthroplasty. The purpose of this study was to compare healing rates and subscapularis fatty infiltration in patients undergoing a lesser tuberosity osteotomy (LTO) versus subscapularis peel for exposure during shoulder arthroplasty. MATERIALS AND METHODS: Eighty-seven patients, with a mean age of 67.8 ± 10.9 years, undergoing shoulder arthroplasty, were randomized to receive either an LTO (n = 43) or peel (n = 44). Computed tomography scans were conducted preoperatively and at 12 months postoperatively. Outcome variables included healing rates and subscapularis Goutallier fatty infiltration grade, as well as subscapularis strength and Western Ontario Osteoarthritis of the Shoulder Index and American Shoulder and Elbow Surgeons outcome scores. RESULTS: Computed tomography imaging was available in 91% (n = 79) of the cohort. The healing rates for the peel (100%) and for the LTO (95%) did not differ significantly (P = .493). Preoperatively, the mean fatty infiltration grade for the peel (mean, 0.53) was not significantly different (P = .925) from the LTO (mean, 0.54). Postoperatively, the Goutallier mean fatty infiltration grade for the peel (mean, 0.95) did not differ significantly (P = .803) from the LTO (mean, 0.9). A significant increase in subscapularis fatty infiltration grade occurred postoperatively from the preoperative status (peel, P = .003; LTO, P = .0002). No statistically significant associations were observed between postoperative fatty infiltration grades and subscapularis strength, Western Ontario Osteoarthritis of the Shoulder Index scores, or American Shoulder and Elbow Surgeons scores. DISCUSSION: No statistically significant differences were observed in the healing rates or subscapularis fatty infiltration grades between the peel and the LTO. This trial does not show any clear difference in radiologic and clinical outcomes of one subscapularis management technique over the other.

Examination Under Anesthesia May Not Be Universally Required Prior to Anti-TNF Therapy in Perianal Crohn's Disease: A Comparative Cohort Study.

BACKGROUND: Multidisciplinary care involving exam under anesthesia (EUA) and tumor necrosis factor (TNF) inhibitors is recommended for perianal Crohn's disease. However, the impact of this combined approach is not well established. METHODS: We performed a comparative cohort study between 2009 and 2019. Patients with perianal Crohn's disease treated with EUA before anti-TNF therapy (combined modality therapy) were compared with anti-TNF alone. The primary outcome was fistula closure assessed clinically. Secondary outcomes included subsequent local surgery and fecal diversion. Multivariable analysis adjusted for abscesses, concomitant immunomodulators, and time to anti-TNF initiation was performed. RESULTS: Anti-TNF treatment was initiated 188 times in 155 distinct patients: 66 (35%) after EUA. Abscesses (50% vs 15%; P < .001) and concomitant immunomodulators (64% vs 50%; P = .07) were more common in the combined modality group, while age, smoking status, disease duration, and intestinal disease location were not significantly different. Combined modality therapy was not associated with higher rates of fistula closure at 3 (adjusted odds ratio [aOR], 0.7; 95% confidence interval [CI], 0.3-1.8), 6 (aOR, 0.8; 95% CI, 0.4-2.0) and 12 (aOR, 1.0; 95% CI, 0.4-2.2) months. After a median follow-up of 4.6 (interquartile range, 5.95; 2.23-8.18) years, combined therapy was associated with subsequent local surgical intervention (adjusted hazard ratio, 2.2; 95% CI, 1.3-3.6) but not with fecal diversion (adjusted hazard ratio, 1.3; 95% CI, 0.45-3.9). Results remained consistent when excluding patients with abscesses and prior biologic failure. CONCLUSIONS: EUA before anti-TNF therapy was not associated with improved clinical outcomes compared with anti-TNF therapy alone, suggesting that EUA may not be universally required. Future prospective studies controlling for fistula severity are warranted.

This comparative cohort study found that an exam under anesthesia before initiation of anti-tumor necrosis factor therapy in perianal Crohn's disease was not associated with higher rates of fistula closure, suggesting that an exam under anesthesia may not be universally required in patients with perianal Crohn's disease.

Video Capsule Endoscopy can Identify Occult Luminal Crohn's Disease in Patients with Isolated Perianal Fistulas.

BACKGROUND: Accurate tools to distinguish Crohn's disease [CD] from cryptoglandular disease in patients with perianal fistulas without detectable luminal inflammation on ileocolonoscopy and abdominal enterography (isolated perianal fistulas [IPF]) are lacking. We assessed the ability of video capsule endoscopy [VCE] to detect luminal inflammation in patients with IPF. METHODS: We studied consecutive adults [>17 years] with IPF who were evaluated by VCE after a negative ileocolonoscopy and abdominal enterography between 2013 and 2022. We defined luminal CD by VCE as diffuse erythema, three or more aphthous ulcers, or a Lewis score greater than 135. We compared rates of intestinal inflammation in this cohort with age- and sex-matched controls without perianal fistulas, who underwent VCE for other indications. We excluded persons with pre-existing inflammatory bowel disease [IBD] and exposure to non-steroidal anti-inflammatory drugs or immunosuppressive treatments. RESULTS: A total of 45 patients with IPF underwent VCE without complications. Twelve patients [26%] met our definition of luminal CD. Luminal CD was more common in patients with IPF than in controls [26% vs 3%; p <0.01]. Among patients with IPF, male sex (OR [odds ratio], 9.2; 95% confidence interval [CI] [1.1-79.4]), smoking (OR, 4.5; 95% CI [0.9-21.2]), abscess (OR, 6.3; 95% CI [1.5-26.8]), rectal enhancement on magnetic resonance imaging [MRI] (OR, 9.0; 95% CI [0.8-99.3]), and positive antimicrobial serology (OR, 7.1; 95% CI, [0.7-70.0]) were more common in those with a positive VCE study. CONCLUSIONS: VCE detected small intestinal inflammation suggestive of luminal CD in approximately one-quarter of patients with IPF. Larger studies are required to validate these findings.

Serial D-dimers after anticoagulant cessation in unprovoked venous thromboembolism: Data from the REVERSE cohort study.

INTRODUCTION: While several risk stratification tools have been developed to predict the risk of recurrence in patients with an unprovoked venous thromboembolism (VTE), only 1 in 4 patients are categorized as low-risk. Rather than a one-time measure, serial D-dimer assessment holds promise to enhance the prediction of VTE recurrence after oral anticoagulant (OAC) cessation. METHODS: Using the REVERSE cohort, we compared VTE recurrence among patients with normal D-dimer levels (<490 ng/mL among males under age 70, <500 ng/mL in others) at OAC cessation and 1-month follow-up, to those with an elevated D-dimer level at either timepoint. We also evaluated VTE recurrence based on absolute increase in D-dimer levels between the two timepoints (e.g., ∆D-dimer) according to quartiles. RESULTS: Among 214 patients with serial D-dimer levels measured at OAC cessation and 1-month follow-up, an elevated D-dimer level at either timepoint was associated with a numerically higher risk of recurrent VTE than patients with normal D-dimer levels at both timepoints (6.9 % vs. 4.2 % per year, hazard ratio 1.6; 95 % CI 0.9-2.7). Among women with <2 HERDOO2 criteria, a normal D-dimer level at both timepoints predicted a very low risk of recurrent VTE during follow-up (0.8 % per year, 95 % CI 0.1-2.8). Irrespective of baseline value, recurrent VTE risk was only 3 % per year (95 % CI 1.4-5.6) among patients in the lowest ∆D-dimer quartile. CONCLUSION: Serial normal D-dimer levels have the potential to identify patients at a low risk of recurrent VTE. In addition, ∆D-dimer, irrespective of its elevation above cutoff threshold, may predict recurrent VTE.

Intraoperative Channeling in Arthroscopic Rotator Cuff Repair: A Multicenter Randomized Controlled Trial.

BACKGROUND: Despite recent advances in arthroscopic rotator cuff repair, the retear rate remains high. New methods to optimize healing rates must be sought. Bone channeling may create a quicker and more vigorous healing response by attracting autologous mesenchymal stem cells, cytokines, and growth factors to the repair site. HYPOTHESIS: Arthroscopic rotator cuff repair with bone channeling would result in a higher healing rate compared with arthroscopic rotator cuff repair without adjuvant channeling. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: Our primary objective was to compare healing rates in patients undergoing arthroscopic rotator cuff repair for degenerative tears, with and without bone channeling. Secondary objectives included comparisons of the Western Ontario Rotator Cuff Index (WORC) score, American Shoulder and Elbow Surgeons (ASES) score, Constant score, Constant strength subscore, and visual analog scale (VAS) for pain score between groups. Patients undergoing arthroscopic rotator cuff repair were recruited at 3 sites and were randomized to receive either bone channeling augmentation or standard repair. Healing was determined via ultrasound at 24 months postoperatively. WORC, ASES, and Constant scores were compared between groups at baseline and at 3, 6, 12, and 24 months postoperatively. RESULTS: A total of 168 patients were enrolled between 2013 and 2018. Intention-to-treat analysis revealed no statistical differences in healing rates between the 2 interventions at 24 months postoperatively. Statistically significant improvements occurred in both groups from preoperatively to all time points for the WORC, the ASES score, the Constant score or Constant strength subscore, and the VAS for pain (P < .0001). No differences were observed between the bone channeling and control groups in WORC, ASES, Constant, and VAS pain scores at any time point. CONCLUSION: This trial did not demonstrate the superiority of intraoperative bone channeling in rotator cuff repair over standard rotator cuff repair at 24 months postoperatively. Healing rates, patient-reported function, and quality-of-life outcomes were similar between groups. REGISTRATION: NCT01877772 (ClinicalTrials.gov identifier).

Daily sedation interruption in mechanically ventilated critically ill patients cared for with a sedation protocol: a randomized controlled trial.

CONTEXT: Protocolized sedation and daily sedation interruption are 2 strategies to minimize sedation and reduce the duration of mechanical ventilation and intensive care unit (ICU) stay. We hypothesized that combining these strategies would augment the benefits. OBJECTIVE: To compare protocolized sedation with protocolized sedation plus daily sedation interruption in critically ill patients. DESIGN, SETTING, AND PATIENTS: Randomized controlled trial of 430 critically ill, mechanically ventilated adults conducted in 16 tertiary care medical and surgical ICUs in Canada and the United States between January 2008 and July 2011. INTERVENTION: Continuous opioid and/or benzodiazepine infusions and random allocation to protocolized sedation (n = 209) (control) or to protocolized sedation plus daily sedation interruption (n = 214). Using validated scales, nurses titrated infusions to achieve light sedation. For patients receiving daily interruption, nurses resumed infusions, if indicated, at half of previous doses. Patients were assessed for delirium and for readiness for unassisted breathing. MAIN OUTCOME MEASURE: Time to successful extubation. Secondary outcomes included duration of stay, doses of sedatives and opioids, unintentional device removal, delirium, and nurse and respiratory therapist clinical workload (on a 10-point visual analog scale [VAS]). RESULTS: Median time to successful extubation was 7 days in both the interruption and control groups (median [IQR], 7 [4-13] vs 7 [3-12]; interruption group hazard ratio, 1.08; 95% CI, 0.86-1.35; P = .52). Duration of ICU stay (median [IQR], 10 [5-17] days vs 10 [6-20] days; P = .36) and hospital stay (median [IQR], 20 [10-36] days vs 20 [10-48] days; P = .42) did not differ between the daily interruption and control groups, respectively. Daily interruption was associated with higher mean daily doses of midazolam (102 mg/d vs 82 mg/d; P = .04) and fentanyl (median [IQR], 550 [50-1850] vs 260 [0-1400]; P < .001) and more daily boluses of benzodiazepines (mean, 0.253 vs 0.177; P = .007) and opiates (mean, 2.18 vs 1.79; P < .001). Unintentional endotracheal tube removal occurred in 10 of 214 (4.7%) vs 12 of 207 patients (5.8%) in the interruption and control groups, respectively (relative risk, 0.82; 95% CI, 0.36-1.84; P = .64). Rates of delirium were not significantly different between groups (53.3% vs 54.1%; relative risk, 0.98; 95% CI, 0.82-1.17; P = .83). Nurse workload was greater in the interruption group (VAS score, 4.22 vs 3.80; mean difference, 0.41; 95% CI, 0.17-0.66; P = .001). CONCLUSION: For mechanically ventilated adults managed with protocolized sedation, the addition of daily sedation interruption did not reduce the duration of mechanical ventilation or ICU stay. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00675363.

Effect of delayed entry of blood culture bottles in BACTEC automated blood culture system in the context of laboratory consolidation.

Delayed entry of blood culture bottles is frequent in consolidated laboratories. A retrospective study evaluated time from insertion to detection and total detection time as a function of preincubation time, and we prospectively looked for false negative results. 69,604 blood culture bottles were reviewed for preincubation time, incubation time and total detection time. Positive cultures for specific bacterial subtypes were reviewed to assess the effect of preincubation time on likelihood of detection. 492 negative blood cultures were prospectively tested by 16S RNA PCR and Staphylococcus-specific PCR for the presence of bacterial DNA. Mean preincubation time for samples collected within the city-limits was 3.94 h versus 9.49-18.89 h for other client sites. Higher preincubation times were partially mitigated by a lower incubation time, with an overall increase in total detection time. A lower odds ratio of recovery of Staphylococcus spp was identified, but not confirmed by terminal subcultures and molecular assays. Prolonged preincubation of blood cultures affects total detection time despite a reduction in incubation time. Successful centralization of microbiological services may depend upon optimization of courier routes for inoculated blood culture bottles. Our data supports consideration for an increase in suggested maximum preincubation times.

Information on the internet for asplenic patients: a systematic review.

BACKGROUND: Asplenic patients in general have poor knowledge about their condition. Patients are increasingly turning to the Internet for their health care information, therefore this is a resource that many asplenic patients will use. The aim of our study was to determine the quality of information on the Internet for asplenic patients. METHODS: We identified websites by entering "splenectomy OR spleen removal" into 3 Internet search engines on July 28, 2008. The top 50 English-language websites from each search engine were included in our analysis. We evaluated the websites with our own 21-point content scale as well as 4 commonly used quality-assessment tools. All websites were analyzed independently by 2 reviewers. Correlations were made between the quality assessment instruments, content, readability and target audience. RESULTS: We included 89 websites in the study. The mean content score percentage for all websites was 49% (95% confidence interval 44%-54%). The long-term risk of infection was mentioned in 84% of websites, and the need for vaccination was mentioned in 79%. The mean quality assessment tool score was 61%, and the mean reading grade level was 11. CONCLUSION: Whereas websites on average did not cover most of the information that asplenic patients should receive, the long-term risk of serious infection and the need for vaccination was consistently mentioned. Websites were inconsistent with respect to adhering to standards advocated by the quality assessment instruments we used, and the mean reading grade level was far above what is recommended for patient literature.

Post-stroke fatigue: A factor associated with inability to return to work in patients <60 years-A 1-year follow-up.

This study investigated the association between post-stroke fatigue and inability to return to work/drive in young patients aged <60 years with first stroke who were employed prior to infarct while controlling for stroke severity, age, extent of disability, cognitive function, and depression. The Fatigue Severity Scale (FSS) was used to evaluate post-stroke fatigue in this 1-year prospective cohort study. Follow-ups were completed at 3, 6, and 12 months post rehabilitation discharge. A total of 112 patients were recruited, 7 were excluded, due to loss to follow-up (n = 6) and being palliative (n = 1), resulting in 105 participants (71% male, average age 49 ±10.63 years). Stroke patients receiving both inpatient and outpatient rehabilitation were consecutively recruited. Persistent fatigue remained associated with inability to return to work when controlling for other factors at 3 months (adjusted OR = 18, 95% CI: 2.9, 110.3, p = 0.002), 6 months (adjusted OR = 29.81, 95% CI: 1.7, 532.8, p = 0.021), and 12 months (adjusted OR = 31.6, 95% CI: 1.8, 545.0, p = 0.018). No association was found between persistent fatigue and return to driving. Fatigue at admission was associated with inability to return to work at 3 months but not return to drive. Persistent fatigue was found to be associated with inability to resume work but not driving. It may be beneficial to routinely screen post-stroke fatigue in rehabilitation and educate stroke survivors and employers on the impacts of post-stroke fatigue on return to work.