Integration of electronic project management software in an investigational drug service pharmacy within an academic medical center.

DISCLAIMER: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE: An investigational drug services (IDS) pharmacy plays a vital role in supporting clinical trial research by ensuring the safe and efficient management of investigational products. This article describes the implementation of an electronic project management software to improve an IDS pharmacy's study protocol work. The article describes the implementation of the software and how this approach addressed specific challenges, including project oversight, process standardization, documentation, reporting, accountability, and intrateam communication. SUMMARY: We describe an electronic project management software system used to streamline and standardize the work associated with study protocols. This software provides an organized and customizable workspace to manage tasks associated with each study protocol. The software automates task creation, tracks progress, and ensures comprehensive record keeping. Additionally, the software fosters effective communication within the team and offers real-time reporting to assess team productivity and progress. We have observed improved consistency, enhanced revenue, including approximately $18,000 in additional fee capture, and increased collaboration among pharmacy team members. CONCLUSION: Implementing an electronic project management software has proven highly beneficial in the IDS pharmacy. The software has significantly improved workflow efficiency by addressing challenges in study protocol management. While initial setup and training required time and resources, the long-term benefits in project oversight, collaboration, and revenue capture justify the investment. An electronic project management software is a valuable tool in managing the complexity of study protocol activities and supports the pharmacy's crucial role in advancing clinical research.

Cost-effectiveness of expanded latent TB infection testing and treatment: Lynn City, Massachusetts, USA.

BACKGROUND: Between October 2016 and March 2019, Lynn Community Health Center in Massachusetts implemented a targeted latent TB infection testing and treatment (TTT) program, increasing testing from a baseline of 1,200 patients tested to an average of 3,531 patients tested, or 9% of the population per year.METHODS: We compared pre-implementation TTT, represented by the first two quarters of implementation data, to TTT, represented by 12 quarters of data. Time, diagnostic, and laboratory resources were estimated using micro-costing. Other cost and testing data were obtained from the electronic health record, pharmaceutical claims, and published reimbursement rates. A Markov cohort model estimated future health outcomes and cost-effectiveness from a societal perspective in 2020 US dollars. Monte Carlo simulation generated 95% uncertainty intervals.RESULTS: The TTT program exhibited extended dominance over baseline pre-intervention testing and had an incremental cost-effectiveness ratio (ICER) of US$52,603 (US$22,008â-"US$95,360). When compared to baseline pre-TTT testing, the TTT program averted an estimated additional 7.12 TB cases, 3.49 hospitalizations, and 0.16 deaths per lifetime cohort each year.CONCLUSIONS: TTT was more cost-effective than baseline pre-implementation testing. Lynn Community Health Centerâ-™s experience can help inform other clinics considering expanding latent TB infection testing.

Analysis of the yearly transition function in measles disease modeling.

Globally, there were an estimated 9.8 million measles cases and 207 500 measles deaths in 2019. As the effort to eliminate measles around the world continues, modeling remains a valuable tool for public health decision-makers and program implementers. This study presents a novel approach to the use of a yearly transition function that formulates mathematically the vaccine schedules for different age groups while accounting for the effects of the age of vaccination, the timing of vaccination, and disease seasonality on the yearly number of measles cases in a country. The methodology presented adds to an existing modeling framework and expands its analysis, making its utilization more adjustable for the user and contributing to its conceptual clarity. This article also adjusts for the temporal interaction between vaccination and exposure to disease, applying adjustments to estimated yearly counts of cases and the number of vaccines administered that increase population immunity. These new model features provide the ability to forecast and compare the effects of different vaccination timing scenarios and seasonality of transmission on the expected disease incidence. Although the work presented is applied to the example of measles, it has potential relevance to modeling other vaccine-preventable diseases.

A systematic review and meta-analysis of the clinimetric properties of the core outcome measurement instruments for clinical effectiveness trials of nutritional and metabolic interventions in critical illness (CONCISE).

BACKGROUND: CONCISE is an internationally agreed minimum set of outcomes for use in nutritional and metabolic clinical research in critically ill adults. Clinicians and researchers need to be aware of the clinimetric properties of these instruments and understand any limitations to ensure valid and reliable research. This systematic review and meta-analysis were undertaken to evaluate the clinimetric properties of the measurement instruments identified in CONCISE. METHODS: Four electronic databases were searched from inception to December 2022 (MEDLINE via Ovid, EMBASE via Ovid, CINAHL via Healthcare Databases Advanced Search, CENTRAL via Cochrane). Studies were included if they examined at least one clinimetric property of a CONCISE measurement instrument or recognised variation in adults ≥ 18 years with critical illness or recovering from critical illness in any language. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist for systematic reviews of Patient-Reported Outcome Measures was used. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses were used in line with COSMIN guidance. The COSMIN checklist was used to evaluate the risk of bias and the quality of clinimetric properties. Overall certainty of the evidence was rated using a modified Grading of Recommendations, Assessment, Development and Evaluation approach. Narrative synthesis was performed and where possible, meta-analysis was conducted. RESULTS: A total of 4316 studies were screened. Forty-seven were included in the review, reporting data for 12308 participants. The Short Form-36 Questionnaire (Physical Component Score and Physical Functioning), sit-to-stand test, 6-m walk test and Barthel Index had the strongest clinimetric properties and certainty of evidence. The Short Physical Performance Battery, Katz Index and handgrip strength had less favourable results. There was limited data for Lawson Instrumental Activities of Daily Living and the Global Leadership Initiative on Malnutrition criteria. The risk of bias ranged from inadequate to very good. The certainty of the evidence ranged from very low to high. CONCLUSIONS: Variable evidence exists to support the clinimetric properties of the CONCISE measurement instruments. We suggest using this review alongside CONCISE to guide outcome selection for future trials of nutrition and metabolic interventions in critical illness. TRIAL REGISTRATION: PROSPERO (CRD42023438187). Registered 21/06/2023.

Adverse events among persons with TB using in-person vs. electronic directly observed therapy.

BACKGROUND: We evaluated patient safety within a randomized crossover trial comparing electronic directly observed therapy (eDOT) to in-person DOT (ipDOT) in persons undergoing TB treatment in New York City, NY, USA.METHODS: Participant symptoms, symptom severity, and clinical management were documented. We assessed adverse event reports (AERs) by DOT method during the two-period crossover. Using Cox proportional-hazards mixed-effects models, we estimated the adjusted hazard ratio (aHR) of participants reporting an adverse event (AE) vs. not reporting an AE.RESULTS: Of 211 participants, 57 (27.0%) reported AEs during the two-period crossover; of these, 54.4% (31/57) were reported while using eDOT vs. 45.6% (26/57) while using ipDOT. Controlling for study group and period, the aHR for eDOT vs. ipDOT was 0.98 (95% CI 0.49-1.93). Although statistically not significant, the wide confidence intervals suggest that a significant association cannot be entirely ruled out. Gastrointestinal symptoms were most frequently reported (42.1%, 24/57). AER types and severity did not differ significantly by DOT method. Days from symptom onset to medical attention was similar across DOT methods (median: 1.0 day, IQR 0.0-2.0). No participants switched DOT methods due to AERs or monitoring concerns.CONCLUSION: Further evaluation to ascertain whether AERs differ when patients use eDOT vs. ipDOT is warranted.

Prewarming effect on adaptation, porosities, and strength of a composite resin.

Warming composite resin before insertion to reduce viscosity is advocated for improving adaptation and reducing voids. This study evaluated how prewarming altered porosities, adaptation, and strength. Twenty composite restorations were placed in 2 increments in typodont teeth with a large Class II preparation. The composite was either at room temperature (control) or prewarmed to 68 °C (n = 10/group). Each increment was light-cured for 20s. After 24h, the restored teeth were sectioned and imaged under a stereomicroscope. Examiners ranked the quality of adaptation to walls and between increments, and the presence of voids on a 0-3 scale. Results were statistically analyzed using Mann-Whitney U Test. Diametral tensile strength of monolithic or incrementally-filled composite cylinders (6 mm diameter × 4 mm height; n = 10/group) made with room temperature or prewarmed composite were tested at 0.5 mm/min. Strength results were analyzed using ANOVA statistics followed by pairwise comparisons. Restorations made with prewarmed composite had significantly fewer large voids and better adaptation to cavity walls and between layers (P < 0.05). Strength of prewarmed composite was higher than room temperature composite, and was significantly higher in monolithic specimens (P < 0.05). It was concluded that prewarming conventional composite can improve its handling, making it handle more like a flowable composite without jeopardizing physical properties. The prewarmed composite was found to have better adaptation and fewer voids, and attained higher strength than composite that was not prewarmed.

Freshwater turtle admissions to a wildlife hospital in South-East Queensland, Australia over an eleven-year period, 2010-2021.

INTRODUCTION: Freshwater turtles in South-East Queensland face a multitude of anthropogenic threats that threaten their survival. Research exploring the morbidity and mortality of animals presented to wildlife hospitals has been used globally to assess the health of species populations, investigate anthropogenic interference and provide valuable information to veterinary professionals about ailments common to a particular species. MATERIALS AND METHODS: Medical records of 1739 chelonian patients admitted to Currumbin Wildlife Hospital, Currumbin, Queensland, Australia between March 2010 and March 2021 were analysed to obtain data on species, diagnoses, outcome and temporal trends. RESULTS: Six species of freshwater turtles were observed, with the Brisbane River turtle (Emydura macquarii signata) being the most common. While there was no significant trend in the number of cases over the study period, there was a decline in the number of Saw-shell turtles (Myuchelys latisternum) admitted each year. Admissions peaked in autumn and summer, likely coinciding with nesting and hatchling emergence. Trauma was the most common diagnosis, accounting for 83% of cases, and saw a decreasing incidence during the study period. In contrast, there was an increasing number of turtles presenting with disease within the same period. Overall, 67.4% of turtles were able to be released after a period of treatment, while 32.6% were euthanised or died due to their condition. Turtles presenting for trauma had the most favourable prognosis, and disease held the poorest prognosis. CONCLUSION AND CLINICAL RELEVANCE: These results confirmed that there are significant anthropogenic threats to freshwater turtle populations in South-East Queensland.

Association Between Genital Hiatus Size 8 Weeks Postpartum and Pelvic Organ Prolapse 1 Year After the First Vaginal Delivery.

IMPORTANCE: Evidence suggests that genital hiatus (GH) enlargement precedes pelvic organ prolapse development remote from delivery. However, the association of postpartum GH enlargement and prolapse is unknown. OBJECTIVE: The aim of this study was to determine the association between enlarged GH at 8 weeks postpartum and prolapse 1 year after first vaginal delivery. STUDY DESIGN: This is a secondary analysis of the Motherhood and Pelvic Health study, a prospective cohort of women after their first vaginal delivery. Enlarged GH was defined as ≥4 cm. Prolapse was defined as Pelvic Organ Prolapse Quantification points Ba, Bp, or C at or beyond the hymen. Kaplan-Meier analysis and proportional hazards modeling were used to analyze the association between enlarged GH at 8 weeks postpartum and prolapse at 1 year postpartum. Diagnostic test characteristics of enlarged GH were calculated. RESULTS: Five hundred eighty women were included. At 1 year postpartum, the prevalence of prolapse was 3 times higher in women with, versus without, an enlarged GH at 8 weeks postpartum (16% vs 5%, P < 0.001). This was confirmed in a Cox proportional hazards model while adjusting for age, body mass index, and early postpartum prolapse (adjusted hazard ratio, 3.3; 95% confidence interval, 1.85-6.06; P < 0.001). The diagnostic properties of postpartum GH to predict prolapse at 1 year are as follows: sensitivity, 0.63; specificity, 0.67; positive predictive value, 0.17; and negative predictive value, 0.95. CONCLUSIONS: Women with an enlarged GH at 8 weeks postpartum have a 3.3-fold increased risk of prolapse at 1 year. As a screening tool, GH <4 cm at 8 weeks postpartum has high negative predictive value.

Multidisciplinary staff perceived barriers and enablers to early mobilization of patients with burns in the ICU.

BACKGROUND: Complex challenges face clinicians managing critically ill patients with burns, particularly in the context of enhancing outcomes after a stay in ICU. Compounding this, a dearth of research explores the specific and modifiable factors that impact early mobilization in the ICU environment. AIM: To explore the barriers and enablers of early functional mobilization for patients with burns in the ICU from a multidisciplinary perspective. DESIGN: A qualitative phenomenological study. METHODS: Semi-structured interviews supplemented by online questionnaires conducted with 12 multidisciplinary clinicians (four doctors, three nurses and five physical therapists) who previously managed burn patients at a quaternary level ICU. Data were thematically analysed. RESULTS: Four main themes: patient, ICU clinicians, the workplace and the physical therapist were identified as impacting on early mobilization. Subthemes identified barriers or enablers to mobilization but all were strongly influenced by overarching theme of the clinician's "emotional filter." Barriers included high levels of pain, heavy sedation and low levels of clinician exposure to treating patients with burns. Enablers included higher levels of clinician's experience and knowledge about burn management and benefits of early mobilization; increased coordinated staff resources when undertaking mobilization; and, open communication and positive culture towards early mobilization across the multidisciplinary team. CONCLUSION: Patient, clinician and workplace barriers and enablers were identified to influencing the likelihood of achieving early mobilization of patients with burns in the ICU. Emotional support for staff through multidisciplinary collaboration and development of structured burns training program were key recommendations to address barriers and strengthen enablers to early mobilization of patients with burns in the ICU.

Introducing RELAX: An automated pre-processing pipeline for cleaning EEG data - Part 1: Algorithm and application to oscillations.

OBJECTIVE: Electroencephalographic (EEG) data are often contaminated with non-neural artifacts which can confound experimental results. Current artifact cleaning approaches often require costly manual input. Our aim was to provide a fully automated EEG cleaning pipeline that addresses all artifact types and improves measurement of EEG outcomes METHODS: We developed RELAX (the Reduction of Electroencephalographic Artifacts). RELAX cleans continuous data using Multi-channel Wiener filtering [MWF] and/or wavelet enhanced independent component analysis [wICA] applied to artifacts identified by ICLabel [wICA_ICLabel]). Several versions of RELAX were compared using three datasets (N = 213, 60 and 23 respectively) against six commonly used pipelines across a range of artifact cleaning metrics, including measures of remaining blink and muscle activity, and the variance explained by experimental manipulations after cleaning. RESULTS: RELAX with MWF and wICA_ICLabel showed amongst the best performance at cleaning blink and muscle artifacts while preserving neural signal. RELAX with wICA_ICLabel only may perform better at differentiating alpha oscillations between working memory conditions. CONCLUSIONS: RELAX provides automated, objective and high-performing EEG cleaning, is easy to use, and freely available on GitHub. SIGNIFICANCE: We recommend RELAX for data cleaning across EEG studies to reduce artifact confounds, improve outcome measurement and improve inter-study consistency.

RELAX part 2: A fully automated EEG data cleaning algorithm that is applicable to Event-Related-Potentials.

OBJECTIVE: Electroencephalography (EEG) is often used to examine neural activity time-locked to stimuli presentation, referred to as Event-Related Potentials (ERP). However, EEG is influenced by non-neural artifacts, which can confound ERP comparisons. Artifact cleaning reduces artifacts, but often requires time-consuming manual decisions. Most automated methods filter frequencies <1 Hz out of the data, so are not recommended for ERPs (which contain frequencies <1 Hz). Our aim was to test the RELAX (Reduction of Electroencephalographic Artifacts) pre-processing pipeline for use on ERP data. METHODS: The cleaning performance of multiple versions of RELAX were compared to four commonly used EEG cleaning pipelines across both artifact cleaning metrics and the amount of variance in ERPs explained by different conditions in a Go-Nogo task. Results RELAX with Multi-channel Wiener Filtering (MWF) and wavelet-enhanced independent component analysis applied to artifacts identified with ICLabel (wICA_ICLabel) cleaned data most effectively and produced amongst the most dependable ERP estimates. RELAX with wICA_ICLabel only or MWF_only may detect effects better for some ERPs. CONCLUSIONS: RELAX shows high artifact cleaning performance even when data is high-pass filtered at 0.25 Hz (applicable to ERP analyses). SIGNIFICANCE: RELAX is easy to implement via EEGLAB in MATLAB and freely available on GitHub. Given its performance and objectivity we recommend RELAX to improve artifact cleaning and consistency across ERP research.

Dissipative Reactions with Intermediate-Energy Beams: A Novel Approach to Populate Complex-Structure States in Rare Isotopes.

A novel pathway for the formation of multiparticle-multihole excited states in rare isotopes is reported from highly energy- and momentum-dissipative inelastic-scattering events measured in reactions of an intermediate-energy beam of ^{38}Ca on a Be target. The negative-parity, complex-structure final states in ^{38}Ca are observed following the in-beam γ-ray spectroscopy of events in the ^{9}Be(^{38}Ca,^{38}Ca+γ)X reaction in which the scattered projectile loses longitudinal momentum of order Δp_{||}=700 MeV/c. The characteristics of the observed final states are discussed and found to be consistent with the formation of excited states involving the rearrangement of multiple nucleons in a single, highly energetic projectile-target collision. Unlike the far-less-dissipative, surface-grazing reactions usually exploited for the in-beam γ-ray spectroscopy of rare isotopes, these more energetic collisions appear to offer a practical pathway to nuclear-structure studies of more complex multiparticle configurations in rare isotopes-final states conventionally thought to be out of reach with high-luminosity fast-beam-induced reactions.

Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE).

BACKGROUND: Clinical research on nutritional and metabolic interventions in critically ill patients is heterogenous regarding time points, outcomes and measurement instruments used, impeding intervention development and data syntheses, and ultimately worsening clinical outcomes. We aimed to identify and develop a set of core outcome domains and associated measurement instruments to include in all research in critically ill patients. METHODS: An updated systematic review informed a two-stage modified Delphi consensus process (domains followed by instruments). Measurement instruments for domains considered 'essential' were taken through the second stage of the Delphi and a subsequent consensus meeting. RESULTS: In total, 213 participants (41 patients/caregivers, 50 clinical researchers and 122 healthcare professionals) from 24 countries contributed. Consensus was reached on time points (30 and 90 days post-randomisation). Three domains were considered 'essential' at 30 days (survival, physical function and Infection) and five at 90 days (survival, physical function, activities of daily living, nutritional status and muscle/nerve function). Core 'essential' measurement instruments reached consensus for survival and activities of daily living, and 'recommended' measurement instruments for physical function, nutritional status and muscle/nerve function. No consensus was reached for a measurement instrument for Infection. Four further domains met criteria for 'recommended,' but not 'essential,' to measure at 30 days post-randomisation (organ dysfunction, muscle/nerve function, nutritional status and wound healing) and three at 90 days (frailty, body composition and organ dysfunction). CONCLUSION: The CONCISE core outcome set is an internationally agreed minimum set of outcomes for use at 30 and 90 days post-randomisation, in nutritional and metabolic clinical research in critically ill adults.

Nivolumab plus low-dose ipilimumab in previously treated patients with microsatellite instability-high/mismatch repair-deficient metastatic colorectal cancer: 4-year follow-up from CheckMate 142.

BACKGROUND: In the phase II multicohort CheckMate 142 study, nivolumab plus low-dose (1 mg/kg) ipilimumab provided robust and durable clinical benefit with a manageable safety profile in previously treated patients with microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC) at 13.4- and 25.4-month median follow-up (Overman MJ, Lonardi S, Wong KYM et al. Durable clinical benefit with nivolumab plus ipilimumab in DNA mismatch repair-deficient/microsatellite instability-high metastatic colorectal cancer. J Clin Oncol. 2018;36:773-779. Overman MJ, Lonardi S, Wong KYM, et al. Nivolumab plus low-dose ipilimumab in previously treated patients with microsatellite instability-high/mismatch repair deficient metastatic colorectal cancer: long-term follow-up. J Clin Oncol. 2019;37:635). Here, we present results from the 4-year follow-up of these patients. PATIENTS AND METHODS: Patients received nivolumab (3 mg/kg) plus low-dose (1 mg/kg) ipilimumab every 3 weeks (four doses) followed by nivolumab (3 mg/kg) every 2 weeks until disease progression. Primary endpoint was investigator-assessed objective response rate (ORR; as per RECIST version 1.1). RESULTS: A total of 119 patients were treated; 76% had ≥2 prior lines of therapy. Median follow-up was 50.9 months (range 46.9-62.7 months). Median duration of therapy was 24.9 months [95% confidence interval (CI) 15.8-33.2 months]. Investigator-assessed ORR increased from 55% (95% CI 45% to 64%) at 13.4 months to 65% (95% CI 55% to 73%) at 50.9 months with a disease control rate of 81% (95% CI 72% to 87%). The complete response rate increased from 3% at 13.4 months to 13% at 50.9 months. Partial responses were observed in 52% of patients; 21% had stable disease, and 12% had progressive disease. Median time to response was 2.8 months (range 1.1-37.1 months), and median duration of response was not reached (range 1.4+ to 58.0+ months). At data cut-off, 37 (48%) patients had ongoing responses. Median progression-free survival was not reached [95% CI 38.4 months-not estimable (NE)], and median overall survival was not reached (95% CI NE). Grade 3-4 treatment-related adverse events (TRAEs) were observed in 32% of patients; 13% of patients had any-grade TRAEs leading to discontinuation. CONCLUSIONS: The results confirm long-term benefit of nivolumab plus low-dose ipilimumab for previously treated patients with MSI-H/dMMR mCRC. The safety profile was manageable with no new safety signals.

Discrimination experienced by sexual minority males in Australia: Associations with suicidal ideation and depressive symptoms.

INTRODUCTION: Discrimination has been under-examined as a social determinant of the higher rates of poor mental health experienced by sexual minorities. The objectives of our study were to: 1) assess whether discrimination was independently associated with poor mental health among sexual minority males, and 2) assess the potential mediation role of discrimination in the associations between sexual minority status and poor mental health. METHODS: We used cross-sectional data on 13,230 males aged 18-55 years from the Australian Longitudinal Study on Male Health; bisexual and homosexual males comprised 1.5% and 1.6% of the sample, respectively. We fit Poisson regression and zero-inflated negative binomial regression models to examine suicidality, depressive symptoms and perceived discrimination in the past two years as correlates of suicidality and depressive symptoms. RESULTS: Statistically significant differences were observed in the prevalence of perceived discrimination by sexual orientation (p < 0.001), with the highest prevalence among bisexual (29.3%) and homosexual (40.4%) males, and the lowest prevalence among heterosexual males (18.6%). After adjusting for confounding, bisexual/homosexual males had higher rates of perceived discrimination (IRR = 1.88, p < 0.001), recent suicidal ideation (IRR = 1.51, p = 0.008), lifetime suicide attempt (IRR = 2.09, p < 0.001) and recent depressive symptoms (IRR = 1.34, p < 0.001) than heterosexual males. Analysis of ß-coefficients suggested that discrimination may mediate a small to moderate proportion of the association between sexual minority status and poor mental health. LIMITATIONS: Use of cross-sectional data. CONCLUSION: Poor mental health is more common among sexual minority males, and discrimination may be a contributor to these mental health disparities. Reducing discrimination should be considered as part of a strategy to improve the mental wellbeing of sexual minority males.

Acute complicated appendicitis caused by an ingested toothpick - A case report.

INTRODUCTION AND IMPORTANCE: Acute appendicitis is one of the most common presentations to the emergency department, particularly in young adults. A combination of clinical suspicion, inflammatory blood markers and imaging modalities such as ultrasound and CT are used for its definitive diagnosis. Early detection and intervention are paramount to reduce morbidity and mortality. Laparoscopic appendicectomy is the current gold standard in the management of appendicitis, especially if complicated according to EAES guidelines. There are few documented cases in the literature of acute appendicitis secondary to foreign body ingestion. On account of this, there are currently no guidelines for its management. Our literature review highlights the importance of surgical management of foreign body acute appendicitis. CASE PRESENTATION: This case report describes the rare presentation of acute complicated appendicitis caused by an ingested toothpick in a 64 year old woman. The patient was admitted with a 3 day history of lower abdominal pain, localizing to the right iliac fossa with raised inflammatory markers. CT imaging reported acute complicated appendicitis. Laparoscopic appendicectomy was performed during which a toothpick was seen protruding through the appendiceal wall. Post operatively the patient was treated with IV antibiotics for 5 days prior to discharge. CLINICAL DISCUSSION: Due to the rare nature of foreign body appendicitis there are no specific guidelines on the respective surgical approach. A literature review showed that in the setting of foreign body appendicitis, surgical intervention is paramount with no scope for conservative management. CONCLUSION: Surgical approach is based on the clinical judgement and skillset of the operating surgeon.

Isolated IgG2 deficiency is an independent risk factor for exacerbations in bronchiectasis.

BACKGROUND: Immunoglobulin G (IgG) subclass 2 deficiency is the most frequent IgG subclass deficiency identified in patients with bronchiectasis, but its clinical significance is not known. AIM: To analyse if bronchiectasis patients with isolated IgG2 deficiency at risk of recurrent exacerbations and/or hospitalization? Do patients with IgG2 deficiency have worse disease progression? DESIGN AND METHODS: This is a retrospective study (2015-20) exploring independent risk factors for recurrent exacerbations (3 or more per year) and/or hospitalization with bronchiectasis exacerbations using multivariable models using binary logistic regression. There was no patient with IgG deficiency, IgG 1, 3 or 4 deficiency, or IgA or IgM deficiency included. In this model, the authors included: serum IgG2 level; lung function; body mass index; MRC breathlessness scale; age; sex; number of bronchiectatic lobes; bacterial colonization; comorbidities; and the use of long-term immunosuppressant drugs or antibiotics for more than 28 days. Analysing 2-year longitudinal data, one-way ANOVA and Mann-Whitney U-test were used to compare bronchiectasis severity between patients with different IgG2 levels. RESULTS: Serum IgG2 levels (<2.68 g/l, 2.68-3.53 g/l and 3.54-4.45 g/l); hospital admission in the preceding 2 years; bacterial colonization with potentially pathogenic organisms and asthma were independent predictors for three or more bronchiectasis exacerbations. Those with low IgG2 levels (<2.68 g/l and 2.68-3.53 g/l), had worsening progression of their bronchiectasis, using the Bronchiectasis Severity Index, over 1 year compared with those who were IgG2 replete (>4.45 g/l) (P = 0.003, 0.013). CONCLUSION: Reduced IgG2 levels were an independent predictor for bronchiectasis exacerbations and have increased disease progression.