Validation of a questionnaire assessing smell loss in an international aspirin-exacerbated respiratory disease population.

Background: Olfactory dysfunction (OD) and smell loss affects aspects of patients' everyday life and lowers their quality of life. OD questionnaires are considered one of the core-outcome measures in chronic rhinosinusitis, but many existing smell loss questionnaires contained pandemic-prohibitive questions on social gatherings or restaurant visits, were too culture specific or gender specific, or were overly long and cumbersome. Objective: We aimed to develop a new brief questionnaire to assess the impact and consequences of smell loss and its burden on daily life. This study validates this new, short, multicultural, dichotomized questionnaire in an international population that has aspirin-exacerbated disease (AERD). Methods: The Consequences of Smell Loss (COSL) questionnaire was developed and content validity was assessed by experts and patients at Brigham and Women's Hospital. The questionnaire, along with other validated quality-of-life surveys, was answered by 853 patients with AERD. We evaluated the factor structure, reliability, validity, and discriminative ability of the COSL questionnaire. Results: The final version of the COSL questionnaire consisted of 13 items divided into three subdomains (emotional distress, food and safety, and physical health) through factor analysis. The Cronbach α for internal consistency was 0.82. Convergent and discriminant validity with the 22-item Sinonasal Outcome Test (SNOT-22), Healthy Days Core Module-4, Patient Health Questionnaire-4, and a specific question on taste and smell were high (p < 0.0001 for all). The COSL questionnaire score was associated with SNOT-22 categories (p < 0.001) and was categorized as follows: normal, 0-1 points; very few consequences, 2-3 points; few, 4 points; moderate, 5-6 points; and severe, 7-13 points. Conclusion: The COSL questionnaire is a new, brief, valid, reliable tool that can effectively screen for a high burden of OD in patients with AERD and has the potential to be used in other patient populations with OD as well.

Rapid and sustained effect of dupilumab on clinical and mechanistic outcomes in aspirin-exacerbated respiratory disease.

BACKGROUND: Dupilumab, a mAb targeting IL-4Rα, improves upper and lower airway symptoms in patients with aspirin-exacerbated respiratory disease (AERD), but the mechanisms leading to clinical improvement are not fully elucidated. OBJECTIVE: Our aim was to identify the mechanistic basis of clinical improvement in patients with AERD treated with dupilumab. METHODS: A total of 22 patients with AERD were treated with dupilumab for 3 months for severe asthma and/or chronic rhinosinusitis with nasal polyps. Clinical outcomes were assessed at baseline and at 1 and 3 months after initiation of dupilumab. Nasal fluid, urine, blood, and inferior turbinate scrapings were collected at the 3 time points for determination of mediator levels, cellular assays, and RNA sequencing. RESULTS: Participants had rapid improvement in clinical measures, including sense of smell, sinonasal symptoms, and lung function after 1 month of treatment with dupilumab; the improvements were sustained after 3 months of dupilumab. Baseline severity of smell loss was correlated with lower nasal prostaglandin E2 levels. Dupilumab increased nasal prostaglandin E2 level and decreased levels of nasal albumin, nasal and urinary leukotriene E4, and serum and nasal IgE. Transcripts related to epithelial dysfunction and leukocyte activation and migration were downregulated in inferior turbinate tissue after treatment with dupilumab. There were no dupilumab-induced changes in nasal eosinophilia. CONCLUSION: Inhibition of IL-4Rα in AERD led to rapid improvement in respiratory symptoms and smell, with a concomitant improvement in epithelial barrier function, a decrease in inflammatory eicosanoid levels, and an increase in the anti-inflammatory eicosanoid prostaglandin E2 level. The therapeutic effects of dupilumab are likely due to decreased IL-4Rα signaling on respiratory tissue granulocytes, epithelial cells, and B cells.

Serum proteomic profiling of rheumatoid arthritis-interstitial lung disease with a comparison to idiopathic pulmonary fibrosis.

Although interstitial lung disease (ILD) causes significant morbidity and mortality in rheumatoid arthritis (RA), it is difficult to predict the development or progression of ILD, emphasising the need for improved discovery through minimally invasive diagnostic tests. Aptamer-based proteomic profiling was used to assess 1321 proteins from 159 patients with rheumatoid arthritis with interstitial lung disease (RA-ILD), RA without ILD, idiopathic pulmonary fibrosis and healthy controls. Differential expression and gene set enrichment analyses revealed molecular signatures that are strongly associated with the presence and severity of RA-ILD and provided insight into unexplored pathways of disease. These warrant further study as non-invasive diagnostic tools and future therapeutic targets.

Loss of smell in patients with aspirin-exacerbated respiratory disease impacts mental health and quality of life.

BACKGROUND: The impact of anosmia on quality-of-life (QoL) for patients with aspirin-exacerbated respiratory disease (AERD) is poorly understood. We aimed to investigate how the severity of smell loss and olfactory dysfunction (OD) in patients with AERD affects their QoL, mental health and physical well-being. METHODS: Five validated QoL questionnaires (Sinonasal Outcome Test-22, Asthma Control Test, Healthy Days Core Module-4, Short Form-36 and Patient Health Questionnaire-4) and two newly developed questionnaires assessing severity and consequences of OD were electronically sent to all 2913 patients in the Brigham and Women's Hospital AERD registry. Responses were received from 853 participants for analysis. RESULTS: Overall, 85% of participants reported a present diminished sense of smell and/or taste, and 30% categorized their OD severity was, "as bad as it can be." There were significant relationships between the severity of self-reported OD and both psychological distress and general health scores, even after adjusting for asthma control. Additionally, incidence rates for physically and mentally unhealthy days in the prior month were higher for patients with moderate or severe OD than for normosmic patients. Patients with diminished smell responded that they could not identify spoiled food (86%), did not enjoy food (71%), felt unsafe (63%) and had encountered dangerous situations (51%) as consequences of their OD. CONCLUSIONS: Anosmia and hyposmia severely impact the physical, emotional and mental health of AERD patients, and lead to safety concerns in their daily lives. The importance of olfaction and the relevance of OD to patients' QoL should be acknowledged and evaluated by clinicians caring for these patients.

Aspirin desensitization and biologics in aspirin-exacerbated respiratory disease: Efficacy, tolerability, and patient experience.

BACKGROUND: Patterns of medication use and efficacy in aspirin-exacerbated respiratory disease (AERD) have not been well characterized, especially since the advent of respiratory biologics. Aspirin therapy after desensitization (ATAD) is efficacious for upper and lower respiratory symptoms for patients with AERD, though aspirin-related adverse effects can limit therapy. The optimal coordination of ATAD and respiratory biologics for the treatment of AERD remains unclear. OBJECTIVE: We aimed to characterize patterns of medication use and treatment experience with biologics and ATAD in AERD. METHODS: We surveyed 98 patients with AERD recruited from the Brigham and Women's Hospital AERD registry. Patients completed an online questionnaire describing their medication history and treatment experience. RESULTS: A total of 52 (53.0%) patients reported a history of use of one or more respiratory biologics (omalizumab, mepolizumab, reslizumab, benralizumab, or dupilumab), and 84 (85.7%) reported undergoing aspirin desensitization. There were 24 patients (24.4%) who reported concurrent use of a biologic and ATAD. Compared with those taking ATAD alone, patients taking a biologic and ATAD concurrently were less likely to report that aspirin was effective for their AERD symptoms (odds ratio, 0.161 [95% confidence interval, 0.03-0.76]; P =.02). Whereas patients reported varying efficacy with biologics, dupilumab had the highest odds of patients reporting it worked "very well" (odds ratio, 17.58 [95% confidence interval, 5.68-54.35]; P < .001). CONCLUSION: Biologics are emerging as a treatment option for AERD and are generally well tolerated. Biologic efficacy in AERD is variable by agent, though most patients taking dupilumab found it to be effective. Patients on a biologic in conjunction with ATAD may represent a more severe subset of AERD for which ATAD alone is insufficient.

Reduced risk of myocardial infarct and revascularization following coronary artery bypass grafting compared with percutaneous coronary intervention in patients with chronic kidney disease.

Coronary atherosclerotic disease is highly prevalent in chronic kidney disease (CKD). Although revascularization improves outcomes, procedural risks are increased in CKD, and unbiased data comparing coronary artery bypass grafting (CABG) and percutaneous intervention (PCI) in CKD are sparse. To compare outcomes of CABG and PCI in stage 3 to 5 CKD, we identified randomized trials comparing these procedures. Investigators were contacted to obtain individual, patient-level data. Ten of 27 trials meeting inclusion criteria provided data. These trials enrolled 3993 patients encompassing 526 patients with stage 3 to 5 CKD of whom 137 were stage 3b-5 CKD. Among individuals with stage 3 to 5 CKD, mortality through 5 years was not different after CABG compared with PCI (hazard ratio [HR] 0.99, 95% confidence interval [CI] 0.67-1.46) or stage 3b-5 CKD (HR 1.29, CI 0.68-2.46). However, CKD modified the impact on survival free of myocardial infarction: it was not different between CABG and PCI for individuals with preserved kidney function (HR 0.97, CI 0.80-1.17), but was significantly lower after CABG in stage 3-5 CKD (HR 0.49, CI 0.29-0.82) and stage 3b-5 CKD (HR 0.23, CI 0.09-0.58). Repeat revascularization was reduced after CABG compared with PCI regardless, of baseline kidney function. Results were limited by unavailability of data from several trials and paucity of enrolled patients with stage 4-5 CKD. Thus, our patient-level meta-analysis of individuals with CKD randomized to CABG versus PCI suggests that CABG significantly reduces the risk of subsequent myocardial infarction and revascularization without affecting survival in these patients.

Helping patients choose between pain control options for outpatient procedural abortion at less than 12 weeks' gestation.

OBJECTIVES: This study aimed to identify predictors of patient satisfaction with their chosen pain control regimen for procedural abortion at <12 weeks' gestation in the outpatient setting. STUDY DESIGN: In this prospective cohort study, we developed an instrument to evaluate predictors of satisfaction with pain control regimens among patients choosing local anesthesia alone (paracervical block with 20 mL of 1% buffered lidocaine) or local anesthesia plus intravenous (IV) moderate sedation with 100 mcg of fentanyl and 2 mg of midazolam. Our primary outcome was to identify predictors of satisfaction with both anesthesia cohorts as measured on a 4-point Likert scale, but due to high satisfaction levels in the IV group, we focused our analysis on the local anesthesia group. RESULTS: We enrolled 149 patients in the local anesthesia group and 155 in the moderate IV sedation group. The mean procedure pain scores were 6.9 (±2.1) out of 10 in the local group and 4.0 (±2.7) in the IV group (p < 0.0001). More women in the IV group (92%) were satisfied or very satisfied with the amount of pain relief they experienced compared to the local group (66%; p < 0.0001). In the univariable model, only being afraid of a minor medical procedure was predictive of less satisfaction with local anesthesia for pain control (relative risk 0.8 [95% CI, 0.6-0.9]). Age, gestational age, anticipated pain, self-reported pain tolerance, self-reported anxiety, discomfort with the abortion decision, and history of prior vaginal or cesarean delivery or induced abortion did not predict satisfaction levels. CONCLUSIONS: Fear of minor medical procedures was the only variable that predicted decreased satisfaction with local anesthesia alone for procedural abortion under 12 weeks. IMPLICATIONS: Reliable predictors for satisfaction with local anesthesia alone for procedural abortion in the outpatient setting remain elusive. Fear of minor medical procedures may serve as an indicator of decreased satisfaction and could be incorporated into patient counseling. Moderate IV sedation is associated with high satisfaction levels.

Intrauterine device knowledge and practices: a national survey of obstetrics and gynecology residents.

OBJECTIVES: The primary objective of this study was to assess the current intrauterine device (IUD) knowledge and counseling practices of US obstetrics and gynecology chief residents. The secondary objective was to evaluate the current IUD experience of obstetrics and gynecology residents. METHODS: A Web-based survey about IUD knowledge and practices was sent to US obstetrics and gynecology residents in January 2010. An analysis of responses by postgraduate year was completed using descriptive statistics. RESULTS: We received 699 surveys (36%) from a pool of 1922 residents in 96 different residency programs. A total of 654 respondents (94%) had placed an IUD during residency and 88% had received formal teaching about IUDs during residency. Only 53% of respondents knew that the copper IUD could be used for emergency contraception. Less than 65% of respondents would routinely recommend the IUD to adolescents or immediately after first trimester abortion. CONCLUSIONS: Many US obstetrics and gynecology residents lack knowledge about IUD benefits and do not counsel all eligible women to use IUDs. We should continue to evaluate our training and educational programs to ensure that women's health providers do not act as a barrier to IUD use.

Acute complications with same-day versus overnight cervical preparation before dilation and evacuation at 14 to 16 weeks.

OBJECTIVE: Evaluate if same-day cervical preparation is associated with a clinically acceptable complication rate compared with overnight osmotic dilators for dilation and evacuation (D&E). STUDY DESIGN: This retrospective, noninferiority, cohort study compared complication rates for same-day versus overnight cervical preparation with D&E between 14 and 16 weeks gestation. Cervical preparation was achieved with misoprostol, osmotic dilators, or both. Our primary outcome was the acute complication rate, defined as: hemorrhage (≥500 mL); hospitalization or hospital transfer; transfusion; or unplanned procedure occurring within 24 hours of the index procedure. Secondarily we evaluated nonmajor (re-aspiration, suture repair of cervical laceration, uterine tamponade, or emergency department only transfer) and major (transfusion, uterine artery embolization, abdominal surgery, or hospital admission) complications separately. Inverse probability of treatment weighting using the propensity score was used to perform an adjusted analysis, taking into account age, ethnicity, clinic location, insurance, gestational age, gravidity, and prior pregnancy outcomes. RESULTS: We analyzed 1,319 subjects (n = 864 same-day, n = 455 overnight). Same-day cervical preparation patients were more likely to have Medicaid and a prior vaginal delivery. In both unadjusted and adjusted analyses, acute complication rates for same-day were noninferior to overnight preparation (unadjusted 0.93% vs 1.98%, difference of -1.05%, CI: -2.48% to 0.38%; adjusted difference -0.50%, CI: -1.45 to 0.44%). Only one major complication in the same-day group, a cervical laceration resulting in hemorrhage requiring transfusion, occurred in the entire sample. CONCLUSIONS: In this retrospective review, same-day cervical preparation was noninferior to overnight preparation for D&E between 14 and 16 weeks gestation, both with low complication rates. IMPLICATIONS: For early second trimester dilation and evacuation, same-day cervical preparation should be considered a safe alternative to overnight cervical preparation.

Physical and psychological recovery after vaginal childbirth with and without epidural analgesia: A prospective cohort study.

BACKGROUND: Enhanced recovery is the gold standard in modern perioperative management, including that for cesarean deliveries. However, qualitative and quantitative data on the physical and psychological recovery of women after vaginal childbirth are limited. Whether neuraxial labor analgesia influences postpartum recovery is unknown. METHODS: Primiparous women anticipating a vaginal childbirth between January 2020 and May 2021 were enrolled. Women with major comorbidities or postpartum complications and those who underwent a cesarean delivery were excluded. Daily step count was measured using a wrist-worn activity tracker (FitbitTM Inspire HR) for 120 hours after vaginal childbirth. Subjective fatigue levels and health-related quality of life were assessed using the Multidimensional Fatigue Inventory (MFI) and EuroQol 5 Dimension 5 Level (EQ-5D-5L), respectively, at the 3rd trimester antenatal visit, on postpartum day 1 and 3, and at the one-month postpartum visit. Rest and dynamic pain scores and the location of pain were documented by participants during postpartum hospitalization. RESULTS: Among 300 women who were enrolled antenatally, 95 and 116 had a vaginal delivery without (NCB group) and with (EPL group) epidural analgesia, respectively. The median number of steps per 24 hours increased daily in both groups, and no significant difference was detected between the groups. Postpartum pain was mild overall, with median rest and dynamic pain scores being less than 4 and similar between the groups. MFI and EQ-5D-5L scores were the worst on postpartum day 1 in both groups and gradually improved to antepartum level by the one-month postpartum visit. Higher MFI score on postpartum day 1, but not the use of epidural analgesia, was associated with lower odds of achieving adequate postpartum ambulation (defined as >3500 steps between 48 and 72 hours postpartum). CONCLUSION: The use of epidural analgesia was not associated with worse recovery outcomes during postpartum hospitalization. TRIAL REGISTRATION: UMIN-CTR, #UMIN000039343, registered on January 31, 2020.

Safety, tolerability, and efficacy of pirfenidone in patients with rheumatoid arthritis-associated interstitial lung disease: a randomised, double-blind, placebo-controlled, phase 2 study.

BACKGROUND: Interstitial lung disease is a known complication of rheumatoid arthritis, with a lifetime risk of developing the disease in any individual of 7·7%. We aimed to assess the safety, tolerability, and efficacy of pirfenidone for the treatment of patients with rheumatoid arthritis-associated interstitial lung disease (RA-ILD). METHODS: TRAIL1 was a randomised, double-blind, placebo-controlled, phase 2 trial done in 34 academic centres specialising in interstitial lung disease in four countries (the UK, the USA, Australia, and Canada). Adults aged 18-85 years were eligible for inclusion if they met the 2010 American College of Rheumatology and European Alliance of Associations for Rheumatology criteria for rheumatoid arthritis and had interstitial lung disease on a high-resolution CT scan imaging and, when available, lung biopsy. Exclusion criteria include smoking, clinical history of other known causes of interstitial lung disease, and coexistant clinically significant COPD or asthma. Patients were randomly assigned (1:1) to receive 2403 mg oral pirfenidone (pirfenidone group) or placebo (placebo group) daily. The primary endpoint was the incidence of the composite endpoint of a decline from baseline in percent predicted forced vital capacity (FVC%) of 10% or more or death during the 52-week treatment period assessed in the intention-to-treat population. Key secondary endpoints included change in absolute and FVC% over 52 weeks, the proportion of patients with a decline in FVC% of 10% or more, and the frequency of progression as defined by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02808871. FINDINGS: From May 15, 2017, to March 31, 2020, 231 patients were assessed for inclusion, of whom 123 patients were randomly assigned (63 [51%] to the pirfenidone group and 60 [49%] to the placebo group). The trial was stopped early (March 31, 2020) due to slow recruitment and the COVID-19 pandemic. The difference in the proportion of patients who met the composite primary endpoint (decline in FVC% from baseline of 10% or more or death) between the two groups was not significant (seven [11%] of 63 patients in the pirfenidone group vs nine [15%] of 60 patients in the placebo group; OR 0·67 [95% CI 0·22 to 2·03]; p=0·48). Compared with the placebo group, patients in the pirfenidone group had a slower rate of decline in lung function, measured by estimated annual change in absolute FVC (-66 vs -146; p=0·0082) and FVC% (-1·02 vs -3·21; p=0·0028). The groups were similar with regards to the decline in FVC% by 10% or more (five [8%] participants in the pirfenidone group vs seven [12%] in the placebo group; OR 0·52 [95% CI 0·14-1·90]; p=0·32) and the frequency of progression as defined by OMERACT (16 [25%] in the pirfenidone group vs 19 [32%] in the placebo group; OR 0·68 [0·30-1·54]; p=0·35). There was no significant difference in the rate of treatment-emergent serious adverse events between the two groups, and there were no treatment-related deaths. INTERPRETATION: Due to early termination of the study and underpowering, the results should be interpreted with caution. Despite not meeting the composite primary endpoint, pirfenidone slowed the rate of decline of FVC over time in patients with RA-ILD. Safety in patients with RA-ILD was similar to that seen in other pirfenidone trials. FUNDING: Genentech.

A comparative evaluation of radiologic and clinical scoring systems in the early prediction of severity in acute pancreatitis.

OBJECTIVES: The early identification of clinically severe acute pancreatitis (AP) is critical for the triage and treatment of patients. The aim of this study was to compare the accuracy of computed tomography (CT) and clinical scoring systems for predicting the severity of AP on admission. METHODS: Demographic, clinical, and laboratory data of all consecutive patients with a primary diagnosis of AP during a two-and-half-year period was prospectively collected for this study. A retrospective analysis of the abdominal CT data was performed. Seven CT scoring systems (CT severity index (CTSI), modified CT severity index (MCTSI), pancreatic size index (PSI), extrapancreatic score (EP), ''extrapancreatic inflammation on CT'' score (EPIC), ''mesenteric oedema and peritoneal fluid'' score (MOP), and Balthazar grade) as well as two clinical scoring systems: Acute Physiology, Age, and Chronic Health Evaluation (APACHE)-II and Bedside Index for Severity in AP (BISAP) were comparatively evaluated with regard to their ability to predict the severity of AP on admission (first 24 h of hospitalization). Clinically severe AP was defined as one or more of the following: mortality, persistent organ failure and/or the presence of local pancreatic complications that require intervention. All CT scans were reviewed in consensus by two radiologists, each blinded to patient outcome. The accuracy of each imaging and clinical scoring system for predicting the severity of AP was assessed using receiver operating curve analysis. RESULTS: Of 346 consecutive episodes of AP, there were 159 (46%) episodes in 150 patients (84 men, 66 women; mean age, 54 years; age range, 21-91 years) who were evaluated with a contrast-enhanced CT scan (n = 131 episodes) or an unenhanced CT scan (n = 28 episodes) on the first day of admission. Clinically severe AP was diagnosed in 29/159 (18%) episodes; 9 (6%) patients died. Overall, the Balthazar grading system (any CT technique) and CTSI (contrast-enhanced CT only) demonstrated the highest accuracy among the CT scoring systems for predicting severity, but this was not statistically significant. There were no statistically significant differences between the predictive accuracies of CT and clinical scoring systems. CONCLUSIONS: The predictive accuracy of CT scoring systems for severity of AP is similar to clinical scoring systems. Hence, a CT on admission solely for severity assessment in AP is not recommended.

Diagnostic yield of dual-phase computed tomography enterography in patients with obscure gastrointestinal bleeding and a non-diagnostic capsule endoscopy.

BACKGROUND AND AIM: In patients with obscure gastrointestinal (GI) bleeding, capsule endoscopy is widely used to determine the source of bleeding. However, there is currently no consensus on how to further evaluate patients with obscure GI bleeding with a non-diagnostic capsule endoscopy examination. This study aims to determine the diagnostic yield of dual-phase computed tomographic enterography (CTE) in patients with obscure GI bleeding and a non-diagnostic capsule endoscopy. METHODS: Patients with obscure GI bleeding who were referred for capsule endoscopy were prospectively enrolled. Obscure GI bleeding was defined as overt if there was obvious GI bleeding; otherwise it was defined as occult. Patients with a non-diagnostic capsule endoscopy and no contraindications underwent a CTE. RESULTS: Capsule endoscopy was performed in 52 patients; 26 patients (50%) had occult GI bleeding and 26 patients (50%) had overt GI bleeding. CTE was then performed in 25 of the 48 patients without a definitive source of bleeding seen on capsule endoscopy. The diagnostic yield of CTE was 0% (0/11) in patients with occult bleeding versus 50% (7/14) in patients with overt bleeding (P < 0.01). Using clinical follow up as the gold standard, for the 25 patients with a non-diagnostic capsule, CTE had a sensitivity of 33% (95% confidence interval 0.15, 0.56) and a specificity of 75% (95% confidence interval 0.22, 0.99). CONCLUSIONS: In patients with a non-diagnostic capsule endoscopy examination, CTE is useful for detecting a source of GI bleeding in patients with overt, but not occult, obscure GI bleeding.

Perioperative dexamethasone administration and risk of bleeding following tonsillectomy in children: a randomized controlled trial.

CONTEXT: Corticosteroids are commonly given to children undergoing tonsillectomy to reduce postoperative nausea and vomiting; however, they might increase the risk of perioperative and postoperative hemorrhage. OBJECTIVE: To determine the effect of dexamethasone on bleeding following tonsillectomy in children. DESIGN, SETTING, AND PATIENTS: A multicenter, prospective, randomized, double-blind, placebo-controlled study at 2 tertiary medical centers of 314 children aged 3 to 18 years undergoing tonsillectomy without a history of bleeding disorder or recent corticosteroid medication use and conducted between July 15, 2010, and December 20, 2011, with 14-day follow-up. We tested the hypothesis that dexamethasone would not result in 5% more bleeding events than placebo using a noninferiority statistical design. INTERVENTION: A single perioperative dose of dexamethasone (0.5 mg/kg; maximum dose, 20 mg), with an equivalent volume of 0.9% saline administered to the placebo group. MAIN OUTCOME MEASURES: Rate and severity of posttonsillectomy hemorrhage in the 14-day postoperative period using a bleeding severity scale (level I, self-reported or parent-reported postoperative bleeding; level II, required inpatient admission for postoperative bleeding; or level III, required reoperation to control postoperative bleeding). RESULTS: One hundred fifty-seven children (median [interquartile range] age, 6 [4-8] years) were randomized into each study group, with 17 patients (10.8%) in the dexamethasone group and 13 patients (8.2%) in the placebo group reporting bleeding events. In an intention-to-treat analysis, the rates of level I bleeding were 7.0% (n = 11) in the dexamethasone group and 4.5% (n = 7) in the placebo group (difference, 2.6%; upper limit 97.5% CI, 7.7%; P for noninferiority = .17); rates of level II bleeding were 1.9% (n = 3) and 3.2% (n = 5), respectively (difference, -1.3%; upper limit 97.5% CI, 2.2%; P for noninferiority < .001); and rates of level III bleeding were 1.9% (n = 3) and 0.6% (n = 1), respectively (difference, 1.3%; upper limit 97.5% CI, 3.8%; P for noninferiority = .002). CONCLUSIONS: Perioperative dexamethasone administered during pediatric tonsillectomy was not associated with excessive, clinically significant level II or III bleeding events based on not having crossed the noninferior threshold of 5%. Increased subjective (level I) bleeding events caused by dexamethasone could not be excluded because the noninferiority threshold was crossed. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01415583.

An assessment of the severity of interstitial pancreatitis.

BACKGROUND & AIMS: There is limited information on the incidence of and factors associated with severe disease among patients with interstitial pancreatitis (IP). We evaluated a large cohort of patients with IP and compared data with those from patients with extrapancreatic necrosis (EXPN). METHODS: We evaluated 149 consecutive patients with IP admitted over a 2.5-year period. Transferred patients were excluded. We collected data on age, Charlson comorbidity score (CCI), measures of severity on admission or within 24 hours (Acute Physiology and Chronic Health Evaluation II, bedside index for severity of acute pancreatitis scores), persistent (>48 h) systemic inflammatory response syndrome, persistent organ failure, need for intensive care unit, length of hospital stay (in days), and mortality. We also analyzed levels of severity among those with IP and EXPN. Statistical analysis was performed using SAS version 9.1 (Cary, NC). RESULTS: Among the patients with IP, the median CCI score was 1, the median Acute Physiology and Chronic Health Evaluation II score was 7, and the median bedside index for severity of acute pancreatitis score was 1. In addition, the median length of hospital stay was only 4 days; only 1% had persistent organ failure and only 1% to 2% required intervention. The mortality rate of IP was 3%; it was associated significantly with comorbidity (the median CCI scores of nonsurvivors and survivors was 4 and 1, respectively, P = .003). Patients with EXPN had greater levels of disease severity, compared with patients with IP. CONCLUSIONS: IP is severe in only 1% to 3% of patients; mortality of IP is associated strongly with comorbidity. EXPN is more frequently severe than IP; EXPN must be distinguished from IP in clinical studies.

Comparative evaluation of the modified CT severity index and CT severity index in assessing severity of acute pancreatitis.

OBJECTIVE: The purpose of this study was to compare the modified CT severity index (MCTSI) with the CT severity index (CTSI) regarding assessment of severity parameters in acute pancreatitis (AP). Both CT indexes were also compared with the Acute Physiology, Age, and Chronic Health Evaluation (APACHE II) index. MATERIALS AND METHODS: Of 397 consecutive cases of AP, 196 (49%) patients underwent contrast-enhanced CT (n = 175) or MRI (n = 21) within 1 week of onset of symptoms. Two radiologists independently scored both CT indexes. Severity parameters included mortality, organ failure, pancreatic infection, admission to and length of ICU stay, length of hospital stay, need for intervention, and clinical severity of pancreatitis. Discrimination analysis and kappa statistics were performed. RESULTS: Although for both CT indexes a significant relationship was observed between the score and each severity parameter (p < 0.0001), no significant differences were seen between the CT indexes. Compared with the APACHE II index, both CT indexes more accurately correlated with the need for intervention (CTSI, p = 0.006; MCTSI, p = 0.01) and pancreatic infection (CTSI, p = 0.04; MCTSI, p = 0.06) and more accurately diagnosed clinically severe disease (area under the curve, 0.87; 95% CI, 0.82-0.92). Interobserver agreement was excellent for both indexes: for CTSI, 0.85 (95% CI, 0.80-0.90) and for MCTSI, 0.90 (95% CI, 0.85-0.95). CONCLUSION: No significant differences were noted between the CTSI and the MCTSI in evaluating the severity of AP. Compared with APACHE II, both CT indexes more accurately diagnose clinically severe disease and better correlate with the need for intervention and pancreatic infection.

Prospective evaluation of quality of life in total versus supracervical laparoscopic hysterectomy.

STUDY OBJECTIVE: To evaluate and compare recovery times and quality of life (QOL) in patients undergoing a total laparoscopic hysterectomy (TLH) and laparoscopic supracervical hysterectomy (LSH). DESIGN: Patients underwent either a TLH or LSH. After surgery, patients maintained a daily log documenting pain, nausea, use of pain medications, and return to daily activities. They also completed a QOL questionnaire (SF-36) before and after surgery. DESIGN CLASSIFICATION: Prospective cohort study (Canadian Task Force Classification II-1). SETTING: University teaching hospital. PATIENTS: A total of 122 women undergoing laparoscopic hysterectomy. MEASUREMENTS AND MAIN RESULTS: A total of 122 women underwent TLH (n = 71) or LSH (n = 51) for benign indications from February 2008 to January 2010. There was a significantly higher postoperative improvement of QOL scores in the LSH group in 6 of 10 questionnaire categories and summary scores, including physical functioning (p =.03), role physical (p =.002), and bodily pain (p =.03). There were no significant differences in use of pain medications, level of pain, level of nausea, or return to normal activities. CONCLUSION: LSH appears to provide greater improvement in short-term postoperative QOL compared with TLH. No significant differences were found in postoperative pain or return to daily activities.

Contraception After Surgical Abortion in Patients With Opioid Use Disorder.

OBJECTIVES: This study describes the prevalence of medications for opioid use disorder (MOUD) among surgical abortion patients, evaluates long-acting reversible contraception (LARC) uptake after surgical abortion among patients on MOUD, and identifies predictors of immediate postabortion LARC uptake among individuals on MOUD. METHODS: We performed a secondary analysis of data from a retrospective observational cohort study of LARC uptake immediately after surgical abortion up to 210/7 weeks gestation at Planned Parenthood League of Massachusetts between October 2012 and April 2017. We estimated proportions and analyzed predictors of LARC uptake among women on MOUD using logistic regression analysis to control for possible confounders. RESULTS: During the study period, 26,858 patients had an abortion procedure; 768 (2.9%; 95% confidence interval, 2.7%-3.1%) used MOUD. In the primary study, controlling for demographic factors, MOUD was not an independent predictor of LARC uptake. In this analysis, patients on MOUD differed demographically from non-MOUD users and were significantly more likely to initiate a LARC method immediately after their procedure: 30.1% versus 25.3% (p = .002), including 22.7% who obtained an intrauterine device and 7.4% who obtained an implant. Among patients on MOUD, a prior live birth and public insurance predicted LARC uptake at the time of abortion. CONCLUSION: Women on MOUD had higher postabortion LARC uptake compared with those not on MOUD in a setting with easy access to postabortion LARC. Public insurance coverage for abortion was associated with LARC uptake among women on MOUD.