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.

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.

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.

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.

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.

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.

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.

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.

Aspirin-Exacerbated Respiratory Disease: Association Between Patient-Reported Sinus and Asthma Morbidity.

BACKGROUND: The association between sinonasal and pulmonary symptoms in aspirin-exacerbated respiratory disease is not fully established. OBJECTIVE: To characterize sinonasal and asthma symptomatology, and to determine whether reported sinonasal symptoms predict asthma severity. METHODS: Prospectively collected data from an aspirin-exacerbated respiratory disease registry cohort were included from 2013 to 2018. Sinonasal symptomatology measured by Sino-Nasal Outcomes Test (SNOT) 22-item total scores was used as the predictor variable, with Asthma Control Test (ACT) scores and percent predicted FEV1 (FEV1% predicted) as primary outcomes. All instances of paired data on the same date were used. ACT score was also evaluated with FEV1% predicted as the outcome. Mixed effects regression was completed. RESULTS: From 1065 aspirin-exacerbated respiratory disease registry subjects (mean age, 48.1 ± 12.8 years; 68.0% females, 29.8% males), mean SNOT-22 score was 42.3 ± 24.12 (n = 1307 observations from 869 subjects), mean ACT score was 19.4 ± 5.2 (n = 1511 observations from 931 subjects), and mean FEV1% predicted was 82.8 ± 19.6 (n = 777 observations from 307 subjects). SNOT-22 score significantly predicted ACT scores (P < .0001, 1185 paired observations from 845 subjects) and FEV1% predicted (P = .018, 485 observations from 246 subjects). Any 10-point increase in SNOT-22 score was associated with a 0.87-point decrease in ACT score and a 0.75% decrease in FEV1% predicted. Any 1-point increase in ACT score was associated with a 1.0% increase in FEV1% predicted (P < .0001, 616 observations from 269 subjects). The most severe SNOT-22 symptoms were sense of smell/taste and blockage/congestion of nose. CONCLUSIONS: SNOT-22 scores significantly predict ACT scores and FEV1% predicted, and ACT scores significantly predict FEV1% predicted. This study demonstrates an association between patient-reported rhinosinusitis and asthma symptom severity and subjective and objective measures of asthma severity.

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.

Palliative Care-Related Knowledge, Attitudes, and Self-Assessment Among Physicians in Vietnam.

CONTEXT: Palliative care is rarely accessible in low- and middle-income countries, and lack of adequate training for health care providers is a key reason. In Vietnam, the Ministry of Health, major hospitals and medical universities, and foreign physician-educators have partnered to initiate palliative care training for physicians. OBJECTIVES: To measure the baseline palliative care-related knowledge, attitudes, and self-assessment of Vietnamese physicians as a basis for curriculum development and to enable evaluation of training courses. METHODS: Before palliative care training courses in Vietnam from 2007 to 2014, we collected data on the participating physicians' demographics, self-assessed competence in palliative care, and palliative care-related knowledge and attitudes. Scores were calculated in three outcome categories-knowledge, attitudes, and self-assessment-and in two subcategories related to physical and psychological symptoms. Associations between the demographic, education, and practice factors and these scores were assessed using linear regression. RESULTS: Among the 392 physicians surveyed, concern about untreated suffering was highly prevalent. 85% felt that most patients with cancer in Vietnam die in pain. On self-assessment, only 8% felt adequately trained in palliative care and the mean knowledge assessment score was 44%. Although 77% had prescribed an opioid in the past year and most had appropriate attitudes toward the use of morphine for pain, the majority reported explicit or implicit restrictions on prescribing morphine. CONCLUSION: There is a great need among Vietnam's physicians for training in palliative care and especially in nonpain and psychological symptom control. Rational, balanced, and clear opioid-prescribing policies are needed to enable physicians to treat pain without fear of repercussions.

A Cohort Analysis of Clinical and Ultrasound Variables Predicting Cancer Risk in 20,001 Consecutive Thyroid Nodules.

CONTEXT: Assessing thyroid nodules for malignancy is complex. The impact of patient and nodule factors on cancer evaluation is uncertain. OBJECTIVES: To determine precise estimates of cancer risk associated with clinical and sonographic variables obtained during thyroid nodule assessment. DESIGN: Analysis of consecutive adult patients evaluated with ultrasound-guided fine-needle aspiration for a thyroid nodule ≥1 cm between 1995 and 2017. Demographics, nodule sonographic appearance, and pathologic findings were collected. MAIN OUTCOME MEASURES: Estimated risk for thyroid nodule malignancy for patient and sonographic variables using mixed-effect logistic regression. RESULTS: In 9967 patients [84% women, median age 53 years (range 18 to 95)], thyroid cancer was confirmed in 1974 of 20,001 thyroid nodules (9.9%). Significant ORs for malignancy were demonstrated for patient age <52 years [OR: 1.82, 95% CI (1.63 to 2.05), P < 0.0001], male sex [OR: 1.68 (1.45 to 1.93), P < 0.0001], nodule size [OR: 1.30 (1.14 to 1.49) for 20 to 19 mm, OR: 1.59 (1.34 to 1.88) for 30 to 39 mm, and OR: 1.71 (1.43 to 2.04) for ≥40 mm compared with 10 to 19 mm, P < 0.0001 for all], cystic content [OR: 0.43 (0.37 to 0.50) for 25% to 75% cystic and OR: 0.21 (0.15 to 0.28) for >75% compared with predominantly solid, P < 0.0001 for both], and the presence of additional nodules ≥1 cm [OR: 0.69 (0.60 to 0.79) for two nodules, OR: 0.41 (0.34 to 0.49) for three nodules, and OR: 0.19 (0.16 to 0.22) for greater than or equal to four nodules compared with one nodule, P < 0.0001 for all]. A free online calculator was constructed to provide malignancy-risk estimates based on these variables. CONCLUSIONS: Patient and nodule characteristics enable more precise thyroid nodule risk assessment. These variables are obtained during routine initial thyroid nodule evaluation and provide new insights into individualized thyroid nodule care.

Prevalence and predictors of initiation of intrauterine devices and subdermal implants immediately after surgical abortion.

OBJECTIVES: To estimate uptake of long-acting reversible contraception (LARC) methods immediately after surgical abortion in a system that makes these methods readily available, and to determine demographic, medical, social, and visit-specific predictors of immediate post-abortion intrauterine device (IUD) and implant initiation. STUDY DESIGN: We performed a retrospective cohort study of LARC (levonorgestrel intrauterine system [IUS], copper IUD, and subdermal implant) initiation at the time of surgical abortion up to 21w0d gestation at Planned Parenthood League of Massachusetts from 2012 through 2017. We calculated proportions of IUD and implant initiation and used mixed effect logistic regression to estimate predictors of each outcome. RESULTS: Among 26,858 surgical abortion patients, 25.4% received immediate post-abortion LARC: 14.2%, 4.2%, and 7.0% received a levonorgestrel IUS, copper IUD, and implant, respectively. Compared to White women, Black women had lower odds of initiating an IUD (aOR 0.81, 95% CI 0.74-0.89). Multiparous women had greater odds than nulliparous women of initiating an IUD (aOR 1.69, 95% CI 1.57-1.82) or implant (aOR 1.36, 95% 1.20-1.53). We found age was the strongest predictor of implant initiation (<18 versus≥35: aOR 3.26, 95% CI 2.26-4.71), but was not associated with IUD uptake. Gestational age was not associated with IUD or implant uptake. Implant uptake increased from 2.4% (2012) to 8.7% (2017) (aOR 3.65, 95% CI 2.36-5.65) while IUD uptake remained fairly constant. CONCLUSION: About 25% of women chose to initiate intrauterine or implantable contraception immediately after surgical abortion when these methods are readily available. Implant uptake has increased significantly in recent years. Women who initiated IUDs and implants differed in their demographic and social profiles. IMPLICATIONS: Women seeking surgical abortion should have same-day access to IUDs and implants. Clinicians and researchers should analyze IUD and implant initiation separately.

A phase I trial of low-dose inhaled carbon monoxide in sepsis-induced ARDS.

BACKGROUND: Acute respiratory distress syndrome (ARDS) is a prevalent disease with significant mortality for which no effective pharmacologic therapy exists. Low-dose inhaled carbon monoxide (iCO) confers cytoprotection in preclinical models of sepsis and ARDS. METHODS: We conducted a phase I dose escalation trial to assess feasibility and safety of low-dose iCO administration in patients with sepsis-induced ARDS. Twelve participants were randomized to iCO or placebo air 2:1 in two cohorts. Four subjects each were administered iCO (100 ppm in cohort 1 or 200 ppm in cohort 2) or placebo for 90 minutes for up to 5 consecutive days. Primary outcomes included the incidence of carboxyhemoglobin (COHb) level ≥10%, prespecified administration-associated adverse events (AEs), and severe adverse events (SAEs). Secondary endpoints included the accuracy of the Coburn-Forster-Kane (CFK) equation to predict COHb levels, biomarker levels, and clinical outcomes. RESULTS: No participants exceeded a COHb level of 10%, and there were no administration-associated AEs or study-related SAEs. CO-treated participants had a significant increase in COHb (3.48% ± 0.7% [cohort 1]; 4.9% ± 0.28% [cohort 2]) compared with placebo-treated subjects (1.97% ± 0.39%). The CFK equation was highly accurate at predicting COHb levels, particularly in cohort 2 (R2 = 0.9205; P < 0.0001). Circulating mitochondrial DNA levels were reduced in iCO-treated participants compared with placebo-treated subjects. CONCLUSION: Precise administration of low-dose iCO is feasible, well-tolerated, and appears to be safe in patients with sepsis-induced ARDS. Excellent agreement between predicted and observed COHb should ensure that COHb levels remain in the target range during future efficacy trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT02425579. FUNDING: NIH grants P01HL108801, KL2TR002385, K08HL130557, and K08GM102695.