Factors associated with keratoconus in Israel-A cross-sectional population-based study.

PURPOSE: To identify potential factors associated with keratoconus. METHODS: This cross-sectional study included data from Israel's largest healthcare provider for the years 2005-2020. Keratoconus patients and age-matched controls were identified. Demographic factors and comorbid conditions, including smoking, diabetes mellitus, asthma, myalgia, mental retardation, Down syndrome, atopic dermatitis and allergy/allergic rhinitis, were compared between the two cohorts. The independent risk factors associated with keratoconus were determined using a multivariable conditional logistic regression model. RESULTS: Overall, 145 508 subjects were reviewed of which 13 228 were keratoconus patients. A ten-fold group (n = 132 280) of age-matched control subjects served as controls for comparisons. In multivariable analysis, several factors were found to be significantly associated with keratoconus. Male gender (OR = 1.27, p < 0.001), Arab ethnicity (OR = 1.50, p < 0.001), diabetes (OR = 1.19, p < 0.001), asthma (OR = 1.50, p < 0.001), myalgia (OR = 1.09, p = 0.02), mental retardation (OR = 2.63, p < 0.001), atopic dermatitis (OR = 1.35, p < 0.001) and allergic rhinitis (OR = 1.21, p < 0.001) were significantly associated with keratoconus. Smoking was significantly protective of keratoconus (OR = 0.66, p < 0.001). CONCLUSIONS: This population-based study reports male gender, Arab ethnicity, diabetes, asthma, myalgia, mental retardation/Down syndrome, atopic dermatitis and allergic rhinitis as factors associated with keratoconus while smoking demonstrates a protective effect. The results of this study could guide enhanced screening strategies and early interventions, particularly for high-risk groups.

Emerging Clinical Features of Acute Mastoiditis in Israel: A Registry Based Cohort.

BACKGROUND AND OBJECTIVES: Acute mastoiditis (AM) is a severe infection in the young population, with possible life-threatening complications. This study aimed to characterize AM presentation, symptoms and signs, complications, and management, over a period of 10 years. METHODS: This large-scale population-based cohort studied "Clalit Health Care" records, to include patients <18 years diagnosed with AM, hospitalized between the years 2008-2018. After validation, we investigated clinical symptoms and signs, pneumococcal vaccination status, complications, laboratory and microbiological parameters, imaging, antibiotic treatment and surgical interventions. RESULTS: AM was diagnosed in 1189 patients, mean age of 2.71 years and 591 (49.71%) were female. Most presented with protrusion of pinna (83.1%), retro auricular redness (73.5%) and fever (71.8%). Patients <2 years of age had more symptoms (3.8 ± 1.4, opposed to 3.6 ± 1.5, P = 0.006) and showed higher white blood cell count and C-reactive protein values. Local and intracranial complications occurred in 233 (20.8%) and 75 (6.5%) patients, respectively. Complications were associated with increased white blood cell count and C-reactive protein and related to bacterial type, specifically Fusobacterium necrophorum (P < 0.0001), for which 50% had an intracranial complication. Between the years 2008-2018, Streptococcus pneumoniae-positive cultures decreased (30.9% to 10.3%, P > 0.0001) as opposed to group-A Streptococcus (10.9% to 30.9%, P = 0.002). CONCLUSIONS: This study shows a difference in AM appearance in the <2 years population and the association between white blood cell count, C-reactive protein and microbiology results with the occurrence of a complication. This may play a role in the management process, such as imaging and intervention needs. Although performed during the pneumococcal vaccine era, the disease microbiology was shown to change significantly throughout the study.

Immediate Unilateral Subpectoral Implant-Based Breast Reconstruction does not Impair Pulmonary Functions: A Preliminary Prospective Study.

BACKGROUND: Implant-based breast reconstruction is one of the most common procedures among women with breast cancer undergoing mastectomy. Prosthetic devices may be positioned either beneath or above the pectoralis major muscle, which is considered an accessory muscle of ventilation. This preliminary prospective study aimed to investigate whether subpectoral unilateral implant-based breast reconstruction has any effect on patients' pulmonary functions. METHODS: A prospective study of fourteen women who underwent immediate unilateral implant-based subpectoral breast reconstruction by a single surgeon over 10 months was conducted. Spirometry and maximal voluntary ventilation tests were conducted 1 day prior to surgery, and 1- and 3 months following breast reconstruction. ANOVA or Friedman test were used to compare pulmonary function tests before and after surgery. RESULTS: Fourteen patients completed the study protocol. No statistically significant differences were found when comparing spirometry parameters in the three time points. CONCLUSIONS: Pectoralis muscle release does not impair pulmonary function among patients undergoing immediate unilateral implant-based breast reconstruction following mastectomy. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Clinical outcomes of clostridioides difficile infection in the very elderly.

BACKGROUND: Clostridioides difficile infection (CDI) causes considerable morbidity, mortality, and economic cost. Advanced age, prolonged stay in healthcare facility, and exposure to antibiotics are leading risk factors for CDI. Data on CDI clinical outcomes in the very elderly patients are limited. METHODS: A retrospective cohort study of patients hospitalized between 2016 and 2018 with CDI. We evaluated demographic clinical and laboratory parameters. Major clinical outcomes were evaluated including duration of hospital stay, admission to intensive care unit (ICU), in-hospital mortality, 30 days post-discharge mortality, and readmission/mortality composite outcome. We compared patients aged up to 80 years (elderly) to those of 80 years old or more (very elderly). RESULTS: Of 196 patients included in the study, 112 (57%) were very elderly with a mean age of 86 versus 67 years in the elderly group. The duration of hospital stays, and intensive care unit admission frequency were significantly reduced in the very elderly (13 vs. 22 days p = 0.003 and 1.8% vs. 10.7% p = 0.01, respectively). No significant difference was found in the frequencies of in-hospital and in 30 days post-discharge mortality. CONCLUSIONS: In our cohort, the duration of hospital stay seemed to be shorter in the very elderly with no increase of in-hospital and post-discharge mortality. Although admitted less frequently to ICU, the in-hospital survival of the very elderly was not adversely affected compared to the elderly, suggesting that very advanced age per se should not be a major factor to consider in determining the prognosis of a patient with CDI.

Identifying Factors Associated With Disparities in Access to Integrative Oncology Program.

CONTEXT AND OBJECTIVES: Cancer centers are increasingly providing complementary medicine as part of an emerging discipline termed 'integrative oncology' (IO). The present study explored factors associated with disparities in referral and adherence to a freely-provided IO program. METHODS: The databases of three oncology centers in northern Israel were searched retrospectively for chemotherapy-treated oncology patients eligible for referral by their oncology healthcare professionals to an integrative physician (IP) consultation. Demographic and cancer-related variables associated with the referral, and attendance by patients at the consultation were identified, as was adherence to the 6-week IO treatment program (high adherence, attending ≥4 IO treatment sessions; low adherence, 0-3 sessions). RESULTS: Of 4988 eligible patients, 1694 (34%) were referred to the IP consultation, with 1331 (78.6%) attending the consultation of which 766 (57.6%) were adherent to IO treatments. Multivariate analysis revealed lower referral rates among patients speaking primarily Arabic and Russian vs. Hebrew (OR = 3.0, 95% CI = 2.0-4.6, P < 0.0001); males vs. females (OR = 1.94, CI = 1.3-2.9, P = 0.001); those not reporting emotional distress (OR = 1.5, CI = 1.02-2.16, P = 0.037); and older age (OR = 1.04, CI = 1.03-1.06, P < 0.0001). Arabic and Russian-speaking patients were less likely to adhere to IO treatments (OR = 0.52, 95% CI = 0.32-0.83, P = 0.006). CONCLUSION: Patients' ethno-national origin and immigration status (primary language, Arabic and Russian), male gender and older age were associated with lower rates of referral to and attendance of the IP consultation, with reduced adherence to weekly IO treatments. These findings require further study to identify barriers toward diversity, equity and inclusion in IO care, increasing awareness among healthcare professionals regarding the benefits of these services for improving patient wellbeing.

Risk factors for recurrent acute mastoiditis in pediatric patients: a registry-based cohort study.

OBJECTIVE: To describe characteristics of pediatric patients with recurrent acute mastoiditis, and to identify risk factors for this condition. STUDY DESIGN: A retrospective cohort study. SETTING: Data based on electronic medical records of the largest Health Maintenance Organization in Israel. METHODS: Children hospitalized due to acute mastoiditis during the years 2008-2018 were identified, and their diagnosis was verified. Patients with recurrent acute mastoiditis were identified and grouped, and their characteristics were outlined and compared to those of the original group to identify risk factors for recurrence. RESULTS: During the 11-year period, a total of 1115 cases of children hospitalized due to acute mastoiditis were identified with a weighted incidence rate of 7.8/100,000. Of this group, 57 patients were diagnosed with recurrence following a full clinical recovery. The incidence proportion of recurrent acute mastoiditis was 5.1% (57/1115), male-to-female ratio was 27:30, 73.4% were younger than 24 months, the median period from the first episode was 3.4 months (IQR 2.0;10.0), and 82.5% of the patients (n = 47) had a single recurrence, whereas 18.5% (n = 10) had two recurrences or more. Mastoidectomy and swelling over the mastoid area during the first episode were identified as the main risk factors for recurrent mastoiditis HR = 4.7 [(2.7-8.2), p < 0.001] and HR = 2.55 [(1.4-4.8), p = 0.003], respectively. Mastoidectomy was the only independent significant risk factor for recurrence in a multivariate analysis. CONCLUSIONS: Mastoidectomy and swelling over the mastoid area during the first episode of acute mastoiditis were found strongly related independent risk factor for future recurrent episodes of acute mastoiditis.

Rhinitis medicamentosa - comparing two treatment strategies: a retrospective analysis.

OBJECTIVE: Rhinitis medicamentosa poses a therapeutic challenge for both patients and physicians. Treatment strategies vary, starting with avoidance of decongestants, followed by medications or surgical intervention. This study aimed to compare two treatment strategies for this condition. METHODS: A review was conducted of patients diagnosed with rhinitis medicamentosa from 2013 to 2021, who were managed conservatively with medications or surgically by inferior turbinate reduction. RESULTS: Forty-seven patients were included: 21 patients were treated conservatively and 26 underwent turbinate reduction. Following surgical therapy, the frequency of using decongestants was significantly reduced (p < 0.001), with a significant improvement in Sino-Nasal Outcome Test-22 scores (p < 0.001). The conservative treatment group was significantly older with more co-morbidities. Following medical therapy, the conservative treatment group had a significant decrease in the frequency of decongestant use, but there was no significant improvement in their Sino-Nasal Outcome Test-22 scores. CONCLUSION: Compared to conservative treatment, inferior turbinate reduction for rhinitis medicamentosa resulted in reduced decongestant use and improved quality of life.

Bronchiectasis with Chronic Rhinosinusitis Is Associated with Eosinophilic Airway Inflammation and Is Distinct from Asthma.

Rationale: Bronchiectasis is an airway inflammatory disease that is frequently associated with chronic rhinosinusitis (CRS). An eosinophilic endotype of bronchiectasis has recently been described, but detailed testing to differentiate eosinophilic bronchiectasis from asthma has not been performed. Objectives: This prospective observational study aimed to test the hypotheses that bronchiectasis with CRS is enriched for the eosinophilic phenotype in comparison with bronchiectasis alone and that the eosinophilic bronchiectasis phenotype exists as a separate entity from bronchiectasis associated with asthma. Methods: People with idiopathic or postinfectious bronchiectasis were assessed for concomitant CRS. We excluded people with asthma or primary ciliary dyskinesia and smokers. We assessed sputum and blood cell counts, nasal NO and fractional excreted NO, methacholine reactivity, skin allergy testing and total and specific immunoglobulin (Ig) E, cytokines in the sputum and serum, and the microbiome in the sputum and nasopharynx. Results: A total of 22 people with CRS (BE + CRS) and 17 without CRS (BE - CRS) were included. Sex, age, Reiff score, and bronchiectasis severity were similar. Median sputum eosinophil percentages were 0% (IQR, 0-1.5%) in BE - CRS and 3% (1-12%) in BE + CRS (P = 0.012). Blood eosinophil counts were predictive of sputum eosinophilia (counts ⩾3%; area under the receiver operating characteristic curve, 0.68; 95% confidence interval, 0.50-0.85). Inclusion of CRS improved the prediction of sputum eosinophilia by blood eosinophil counts (area under the receiver operating characteristic curve, 0.79; 95% confidence interval, 0.65-0.94). Methacholine tests were negative in 85.7% of patients in the BE - CRS group and 85.2% of patients in the BE + CRS group (P > 0.99). Specific IgE and skin testing were similar between the groups, but total IgE levels were increased in people with increased sputum eosinophils. Microbiome analysis demonstrated distinct microbiota in nasopharyngeal and airway samples in the BE + CRS and BE - CRS groups, without significant differences between groups. However, interactome analysis revealed altered interactomes in individuals with high sputum eosinophil counts and CRS. Conclusions: Bronchiectasis with CRS is associated with an eosinophilic airway inflammation that is distinct from asthma.

The Risk of Herpes Zoster Events in Patients with Spondyloarthritis and the Effect of BNT162b2 mRNA COVID-19 Vaccine.

The data on the risk of herpes zoster (HZ) in spondyloarthropathy (SpA) patients are sparse, especially regarding its association with the novel mRNA COVID-19 vaccines and immunosuppressants. We aimed to evaluate whether SpA diagnosis and/or immunosuppressant use affect HZ risk and the influence of mRNA COVID-19 vaccination. We assessed the association between SpA (psoriatic arthritis (PsA) and ankylosing spondylitis (AS)) diagnoses and HZ in a large population database with patients matched by age and sex to controls. We also assessed the association between the COVID-19 vaccine and new-onset HZ using two nested case-control studies, identifying all new HZ cases diagnosed from 1 January-31 December 2021 within the SpA and general population cohorts, matched randomly by sex, age and HZ index date to controls without HZ. Exposure to mRNA COVID-19 vaccination was ascertained in the 6 weeks prior to the index date both in cases and controls. In our results, the incidence rate of HZ was higher in PsA patients vs. the general population, at 1.03 vs. 0.64 per 100 person-years, respectively (adjusted HR = 1.55; 95%CI, 1.19-2.02). Within the SpA group, Jak-I treatment was associated with a higher risk of developing new-onset HZ (adjusted OR = 3.79; 1.15-12.5). Multivariable conditional logistic regression models we used showed no association between COVID-19 vaccination and new-onset HZ among the SpA patients (OR = 1.46; 0.68-3.14).

Xylitol nasal spray for prevention of recurrent acute otitis media in children: A prospective two-center cohort study.

OBJECTIVES: The purpose of this study was to assess the effectiveness and safety of xylitol nasal spray as a prophylactic treatment for children with recurrent acute otitis media (AOM). METHODS: This is a prospective pilot study of children aged 1-4 years, diagnosed with recurrent AOM (at least three episodes in the three months before recruitment) between December 1, 2019 and January 31, 2023. Children were treated with nasal xylitol spray 2-3 times daily for 3 months. The number of AOM episodes and treatments administered were compared within 3-month intervals: before recruitment, during xylitol use, and during the three subsequent months. RESULTS: Of 68 children enrolled, 66 (97%) completed the follow-up, until July 2023. Thirty-eight (58%) were males. Sixty-three children (95%) were 12-24-months old. The mean number of AOM episodes during xylitol use, 1.06 (95% confidence interval [CI]: 0.73-1.39), was lower than in the 3-month previous interval, 4.12 (95% CI: 3.89-4.40), p < 0.001; and similar to that in the subsequent 3-month interval, 0.79 (95% CI: 0.49-1.08), p = 0.082. A similar pattern was observed in an analysis of the number of AOM episodes per patient month. The data were similar during spring and summer months as during autumn and winter months. Across the consecutive three-month intervals, decreases were observed in the mean number of AOM episodes treated with systemic antibiotics (3.35, 0.65, and 0.41), p < 0.001; and with topical antibiotics (1.38, 0.55, and 0.32), p < 0.001. No major side effects were recorded. CONCLUSIONS: The findings support the effectiveness and safety of nasal xylitol spray, for preventing recurrent AOM in children aged 1-4 years.

Genotype-Specific Cortisol Reserve in a Cohort of Subjects With Nonclassic Congenital Adrenal Hyperplasia (NCCAH).

CONTEXT: Recent guidelines suggest that patients with nonclassic congenital adrenal hyperplasia (NCCAH) stop glucocorticoid therapy after achieving adult height. However, these guidelines do not differentiate between NCCAH genotype groups. OBJECTIVE: Compare ACTH-stimulated cortisol and 17-hydroxyprogesterone (17OHP) levels, and the rate of partial cortisol insufficiency in subjects with NCCAH carrying one mild and one severe (mild/severe) mutation vs subjects with biallelic mild (mild/mild) mutations. METHODS: Retrospective evaluation of the medical records of 122 patients who presented with postnatal virilization and were diagnosed with NCCAH. Patients underwent standard intravenous 0.25 mg/m2 ACTH stimulation testing. Those with stimulated 17OHP level ≥40 nmol/L were screened for the 9 most frequent CYP21A2 gene mutations followed by multiplex ligation-dependent probe amplification. A stimulated cortisol level below 500 nmol/L was defined as partial cortisol deficiency. RESULTS: Patients were subdivided into 3 genotype groups: 77 carried the mild/mild genotype, mainly homozygous for p.V281L mutation; 29 were compound heterozygous for mild/severe mutation, mainly p.V281L/p.I2Splice, and 16 were heterozygous for p.V281L, and were excluded from statistical evaluation. Stimulated cortisol levels were significantly lower in the mild/severe than in the mild/mild group (mean ± SD, 480 ± 90 vs 570 ± 125 nmol/L, P < .001). The mild/severe group exhibited a significantly higher rate of partial cortisol insufficiency (21/28, 75% vs 28/71, 39%, P = .004). Peak 17OHP was significantly higher in the mild/severe group (198 ± 92 vs 118 ± 50 nmol/L, P < .001). CONCLUSION: The high rate of partial adrenal insufficiency in the mild/severe group underscores the need to carefully consider the value of glucocorticoid therapy cessation and the importance of stress coverage in this group.

Treatment Persistence of Apremilast Among Patients with Psoriatic Arthritis.

Introduction: Persistence in drug therapy reflects treatment effectiveness and tolerability. We aim to estimate the persistence of apremilast prescribed to patients with psoriatic arthritis (PsA) and to identify characteristics associated with treatment discontinuation in a real-world setting. Methods: Patients with PsA treated with apremilast from January 2016 were identified from a large health database and followed until medication stop date (using 3-months grace period), death or the end of observation period (June 2021). Demographic data, Charlson comorbidity index and concomitant and previous use of conventional and biologic DMARDs were extracted. The reasons for drug discontinuation were manually retrieved from patient charts. Time to discontinuation was estimated using survival analysis using Kaplan-Meier functions. Results: Overall, 568 PsA patients treated with apremilast were identified. The mean age was 55.3±14.0 years, of whom 332 (58.5%) were females, 38.4% were obese (BMI>30), 75.2% had a Charlson comorbidity index>1, 24.1% were on concomitant treatment with methotrexate and 72.4% were biologic naïve. The median persistent period was 6.1,95% CI (5.2-6.9) months in which only 16.9% remained persistent on apremilast. No difference was found with regard to age, sex, socioeconomic status, ethnicity and obesity between patients who were persistent compared to patients who discontinued apremilast. Concomitant treatment with methotrexate and prior history of biologic therapy did not affect drug persistency (log rank P=0.957 and 0.082, respectively). Causes for treatment discontinuation were due to lack of skin efficacy in 19.4%, lack of joint efficacy in 33.3%, combined skin and joint inefficacy at 2.3% and due to side effects in 24.1%. Conclusion: In this large observational retrospective cohort of patients treated with apremilast, a relatively low drug persistence was observed with 6-month and 1-year survival rates of 50.3% and 31.3%, respectively. Treatment discontinuation was mainly due to joint inefficacy, advocating for more studies for proper patient selection to assure treatment effectiveness and persistency.

Trends in occurrence of takotsubo syndrome and association with SARS-CoV-2 infection and COVID-19 vaccination.

AIMS: Takotsubo syndrome (TTS) is a serious heart disease associated with significant morbidity and mortality. TTS has been related to SARS-CoV-2 infection and COVID-19 vaccine; however, the current data are scarce. We aimed to examine the associations between SARS-CoV-2 infection and its vaccine with TTS. METHODS: We conducted a nested case-control study in a cohort of 3 237 909 adults from the largest healthcare provider in Israel. Patients were followed from 1 March 2020 until 31 December 2021 for the occurrence of TTS. Ten randomly selected controls were matched to each case of TTS on age, sex, and duration of follow-up. Exposure to SARS-CoV-2 infection and COVID-19 vaccine in the prior 30 days was assessed in cases and controls. RESULTS: During the follow-up 144 patients developed TTS and were matched to 1440 controls. The mean age of cases and their matched controls was 71.4 ±â€Š12 years, and 136 (94.4%) of them were women. Conditional logistic regression analysis showed that SARS-CoV-2 infection and COVID-19 vaccine were not associated with an increased risk of TTS; odds ratio (OR) = 2.04 [95% confidence interval (CI), 0.50-8.2] and 0.87 (0.49-1.54), respectively. The absolute number of TTS cases in the prepandemic period (March-December 2018-2019) was 82 in 2018 and 80 in 2019. The number of TTS cases decreased to 56 during the corresponding period of 2020 (first pandemic year) and increased back to 81 in 2022. CONCLUSION: No significant association was found between SARS-CoV-2 infection or COVID-19 vaccination and TTS occurrence.

A randomized-controlled trial assessing the effect of intraoperative acupuncture on anesthesia-related parameters during gynecological oncology surgery.

CONTEXT AND OBJECTIVES: The present study examined the impact of intraoperative acupuncture on anesthesia-related parameters in patients undergoing gynecological oncology surgery. METHODS: Participants underwent preoperative integrative oncology (IO) touch/relaxation treatments, followed by intraoperative acupuncture (Group A); preoperative IO treatments without acupuncture (Group B); or standard care only (Group C). Mean arterial pressure (MAP), heart rate (HR), MAP variability (mean of MAP standard deviation), bispectral index (BIS), and calculated blood pressure Average Real Variability (ARV) were measured intraoperatively. RESULTS: A total of 91 patients participated: Group A, 41; Group B, 24; Group C, 26. Among patients undergoing open laparotomy, Group A showed lower and more stable MAP and HR compared to Group B, (MAP, p = 0.026; HR, p = 0.029) and Group C (MAP, p = 0.025). Mean BIS, from incision to suture closing, was lower in Group A (vs. controls, p = 0.024). In patients undergoing laparoscopic surgery, MAP was elevated within Group A (p = 0.026) throughout surgery, with MAP variability significantly higher in Group A (P = 0.023) and Group B (P = 0.013) 10 min post-incision (vs. pre-incision). All groups showed similar intraoperative and post-anesthesia use of analgesic medication. CONCLUSION: Intraoperative acupuncture was shown to reduce and stabilize MAP and HR, and reduce BIS in gynecology oncology patients undergoing laparotomy, with no impact on perioperative analgesic medication use. In the laparoscopic setting, intraoperative acupuncture was associated with elevated MAP. Further research is needed to explore the hemodynamic and BIS-associated benefits and risks of intraoperative acupuncture, and the impact on the use of analgesic drugs in response to these changes.

Development of Autoantibodies Following BNT162b2 mRNA COVID-19 Vaccination and Their Association with Disease Flares in Adult Patients with Autoimmune Inflammatory Rheumatic Diseases (AIIRD) and the General Population: Results of 1-Year Prospective Follow-Up Study.

Development of autoantibodies following BNT162b2 mRNA COVID-19 vaccination and their association with disease flares in adult patients with autoimmune inflammatory rheumatic diseases (AIIRD) and the general population: results of 1-year prospective follow-up study. We conducted a prospective study aimed at investigating the incidence of appearance of autoantibodies (antinuclear, antiphospholipid, and rheumatoid factor) in the sera of 463 adult patients with AIIRD compared to 55 controls from the general population prior to, and following the second and third vaccine doses, and at 1-year of follow-up. Pre- and post-vaccination disease activity indices and the association of autoantibodies with rheumatic disease flares and new onset AIIRD were examined. Autoantibody development of any type in AIIRD patients vs. the controls was 4.0% (vs. 6.7%, p = 0.423) following two vaccine doses and 7.6% (vs. 0%, p = 0.152) after three doses. There was no significant difference in sex, age, or disease-type among individuals with and without autoantibody development, regardless of the immunosuppressant use. More patients developed autoantibodies following the third than the second vaccine dose (p = 0.004). Disease flares occurred in 5.8% and 7.2% of AIIRD patients following second and third vaccine doses, respectively, with autoantibody production increasing the risk of flares following the second (p = 0.002) and third (p = 0.004) vaccine doses. BNT162b2 vaccination resulted in the development of autoantibodies in a minority of AIIRD patients and controls. Autoantibody development was associated with disease flares in patients, but no new-onset autoimmunity was observed.

Acupuncture during gynecological oncology surgery: A randomized controlled trial assessing the impact of integrative therapies on perioperative pain and anxiety.

BACKGROUND: In this study, the impact of a multimodal integrative oncology pre- and intraoperative intervention on pain and anxiety among patients undergoing gynecological oncology surgery was explored. METHODS: Study participants were randomized to three groups: Group A received preoperative touch/relaxation techniques, followed by intraoperative acupuncture; Group B received preoperative touch/relaxation only; and a control group (Group C) received standard care. Pain and anxiety were scored before and after surgery using the Measure Yourself Concerns and Wellbeing (MYCAW) and Quality of Recovery (QOR-15) questionnaires, using Part B of the QOR to assess pain, anxiety, and other quality-of-life parameters. RESULTS: A total of 99 patients participated in the study: 45 in Group A, 25 in Group B, and 29 in Group C. The three groups had similar baseline demographic and surgery-related characteristics. Postoperative QOR-Part B scores were significantly higher in the treatment groups (A and B) when compared with controls (p = .005), including for severe pain (p = .011) and anxiety (p = .007). Between-group improvement for severe pain was observed in Group A compared with controls (p = .011). Within-group improvement for QOR depression subscales was observed in only the intervention groups (p <0.0001). Compared with Group B, Group A had better improvement of MYCAW-reported concerns (p = .025). CONCLUSIONS: A preoperative touch/relaxation intervention may significantly reduce postoperative anxiety, possibly depression, in patients undergoing gynecological oncology surgery. The addition of intraoperative acupuncture significantly reduced severe pain when compared with controls. Further research is needed to confirm these findings and better understand the impact of intraoperative acupuncture on postoperative pain. PLAIN LANGUAGE SUMMARY: Integrative oncology programs are increasingly becoming part of supportive/palliative care, with many working within the Society for Integrative Oncology. This study examined the impact of a multimodal integrative oncology program on pain and anxiety among 99 patients undergoing gynecological oncology surgery. Participants were randomized to three groups: preoperative touch/relaxation treatments, followed by intraoperative acupuncture; preoperative touch/relaxation without acupuncture; and a control group receiving standard care only. The preoperative touch/relaxation intervention significantly reduced perioperative anxiety, with the addition of intraoperative acupuncture significantly reducing severe pain as well, when compared with controls. Further research is needed to confirm these findings.

Effectiveness of Evusheld in Immunocompromised Patients: Propensity Score-Matched Analysis.

BACKGROUND: Tixagevimab and cilgavimab, a combined monoclonal antibody (Evusheld), was granted emergency use authorization for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) preexposure prophylaxis in individuals with immunocompromising conditions. In this study we used population-based real-world data to evaluate the effectiveness of Evusheld in immunocompromised patients. METHODS: Using the computerized database of the largest healthcare provider in Israel, we identified all adult immunocompromised patients who were eligible to receive Evusheld (150 mg tixagevimab and 150 mg cilgavimab) on 15 February 2022. Patients with a documentation of a prior SARS-CoV-2 infection were excluded. A total of 703 patients who received Evusheld were propensity score matched, using a ratio of 1:4, with 2812 patients who had not received Evusheld (control group). Patients were followed through 30 June 2022 for up to 90 days for the first documentation of SARS-CoV-2 infection and coronavirus disease 2019 (COVID-19)-related hospitalization. RESULTS: Overall, 72 patients in the Evusheld group and 377 patients in the control group had SARS-CoV-2 infection, reflecting an incidence rate of 4.18 and 5.64 per 100 person-months, respectively. The hazard ratios were 0.75 (95% confidence interval [CI]: .58-.96) for SARS-CoV-2 infection and 0.41 (95% CI: .19-.89) for COVID-19-related hospitalization in the Evusheld group compared to the control group. The magnitude of relative risk reduction of each outcome was greater in nonobese patients (P for interaction = .020 and .045, respectively). CONCLUSIONS: This study suggests that Evusheld is effective in reducing the risk of SARS-CoV-2 infection and COVID-19 hospitalization in immunocompromised patients. The effectiveness of this dose appears to be greater in nonobese patients.

Treatment effects of Elexacaftor/Tezacaftor/Ivacaftor in people with CF carrying non-F508del mutations.

BACKGROUND: In vitro studies have demonstrated rescue of CFTR function with Elexacaftor/Tezacaftor/Ivacaftor (ETI) in several mutations other than F508del. However, clinical efficacy was not tested in vivo in people with CF (pwCF) carrying mutations other than F508del. We report effects of treatment with ETI in pwCF with non-F508del mutations. METHODS: We retrospectively analyzed pwCF with non-F508del mutations who received treatment with ETI. We evaluated sweat chloride, nutritional status, spirometry, antibiotic treatment, and pulmonary exacerbations (PEx), at baseline and 3-6 months after commencing treatment with ETI. RESULTS: We included 16 pwCF, including eight without previous use of CFTR modulators. Median time on treatment was 5.3 (range, 1.8-7.7) months. Compared to baseline, in the "naïve" group sweat chloride concentration was reduced from 113.0 (98-129) to 64.0 (32-97) mEq/L (n=7; median (IQR), p=0.018), and rate of pulmonary exacerbations declined from a median of 1.5 (IQR 1, 2.75) in the previous year to 0 (0,0) (p= 0.019) with a significant decline in annualized days with antibiotics (oral + parenteral) per year: 36 (17.5; 42) in the year before to 0 (0,0) (median (IQR), p= 0.027). Mean FEV1% changed from 66.3±25 to 72.4±29 % (mean ± SD, p=0.058). In the group of patients previously treated with Ivacaftor or Tezacaftor/Ivacaftor, we didn't observe significant improvements in any of the parameters. CONCLUSIONS: We demonstrate the clinical efficacy of ETI in pwCF carrying CFTR processing non-F508del mutations which are predicted to respond by in vitro studies. Our results support routine clinical use of ETI in this patient group.