Median Number Of Days Research Articles

Clinical and microbiological characteristics of and risk factors for bloodstream infections among patients with extracorporeal membrane oxygenation: a single-center retrospective cohort study

Extracorporeal membrane oxygenation (ECMO) provides hemodynamic and oxygenation support to critically ill patients. Due to multiple catheter cannulations, patients on ECMO are vulnerable to bloodstream infections (BSIs). We aimed to investigate the incidence, clinical characteristics, risk factors, and microorganisms associated with BSIs during ECMO. This single-center retrospective cohort study was conducted between January 2015 and May 2021. Patients aged 18 years or older with an ECMO duration of > 48 h for cardiogenic or respiratory support were included in the study. Patients who developed bacteremia or candidemia from 12 h after ECMO cannulation to 7 days after de-cannulation were included. The clinical factors between non-BSI and BSI were compared, along with an analysis of the risk factors associated with BSI during ECMO. A total of 480 patients underwent ECMO for cardiogenic shock (n = 267, 55.6%) or respiratory failure (n = 213, 44.4%) during the study period. The incidence was 20.0 episodes per 1000 ECMO-days. Approximately 20.2% (97/480) and 5.4% (26/480) of the patients developed bacteremia and candidemia, respectively. The median numbers of days of BSI development were 8.00 days for bacteremia and 11.0 days for candidemia. The most common pathogens were methicillin-resistant coagulase-negative staphylococci (n = 24), followed by vancomycin-resistant Enterococcus (n = 21). Multivariable logistic analysis demonstrated that hemodialysis (odds ratio [OR] 2.647, p < 0.001), veno-arterial-venous mode (OR 1.911, p = 0.030), and total ECMO duration (OR 1.030, p = 0.007) were significant risk factors for bacteremia. The total ECMO duration was the only risk factor associated with candidemia (OR 1.035, p = 0.010). The mortality rate was significantly higher in the bacteremia (57.7%) and candidemia (69.2%) groups than that in the non-BSI group (43.6%). BSI is a common complication of patients receiving ECMO support and is associated with poor clinical outcomes. Determining the type of frequently isolated organisms and the median onset time of BSI would help in the selection of appropriate prophylactic antibiotics or antifungal agents.

Adult pure red cell aplasia at Universitas Academic Hospital, Bloemfontein, South Africa: A 9-year review.

Pure red cell aplasia (PRCA) is characterised by severe normochromic, normocytic anaemia and partial or complete absence of reticulocytes from the peripheral blood. With bone marrow of normal cellularity, an almost complete absence of erythroblasts but preservation of other cell lines is observed. It may be congenital or acquired, with the latter presenting as a primary haematological disorder or secondary to various contributing factors. Management focuses on treatment of the underlying cause and supportive transfusions. Occasionally, immunosuppression or intravenous immunoglobulin (IVIG) is required. To describe the clinical characteristics, treatment and outcomes of adult patients diagnosed with PRCA at Universitas Academic Hospital (UAH) in Bloemfontein, South Africa, from 2010 to 2018. A retrospective descriptive file review was performed. All adult patients diagnosed with PRCA and treated in the Division of Clinical Haematology at UAH during the study period were included. Variables recorded included demographic information, clinical details of the PRCA diagnosis, classification of the PRCA, HIV and parvovirus B19 test results, results of special investigations, medical and drug history, treatment and response to treatment. Twenty-seven patients' files were included, with a female predominance (n=22; 81.5%). The median age at diagnosis was 35 years (range 20 - 62). The median number of days from onset of symptoms to date of diagnosis was 61 days (range 27 - 114). Approximately half (n=13; 48.2%) of the patients presented with a haemoglobin concentration of 1 - 3 g/dL. Most patients (n=26; 96.3%) were infected with HIV, with 76.9% (n=20) having a suppressed viral load. Parvovirus B19 infection accounted for 44.4% of cases (n=12), and all these patients were HIV positive. Lamivudine was a probable cause of PRCA in 18.5% of cases, although the true causal relationship was uncertain. Corticosteroids and IVIG were first-line therapy in 44.4% (n=12) and 37.0% (n=10) of cases, respectively. Thirteen patients (48.2%) achieved a complete response and 7 (25.9%) a partial response, while 2 (7.4%) showed no response, with continued transfusion dependence. In this population, women were disproportionately affected by PRCA. HIV was the single most important cause of acquired PRCA, which was independent of virological control. Parvovirus B19 and drugs were also important causes of acquired PRCA and played a critical part in the evaluation and work-up of PRCA. Nearly half of the patients achieved a complete response to therapy, which was sustained over 24 months.

Mental Health Beliefs, Access, and Engagement with Military Sexual Trauma–Related Mental Health Care

BackgroundMilitary sexual trauma (MST) is associated with negative mental health outcomes. Mental health beliefs, such as stigma or secondary victimization, have been identified as possible barriers to care; however, it is unclear whether such beliefs impact receiving care.ObjectiveTo assess if mental health beliefs impact MST-related mental health care access and engagement.DesignVeterans completed a survey following detection of MST. Survey data were linked to Veteran's Health Administration administrative data in order to examine associations with outpatient MST-related care in the year following MST detection.ParticipantsA national sample of women and men Veterans (N = 1,185) with newly detected MST who reported a perceived need for MST-related mental health treatment.Main MeasuresBuilding on prior work that identified four latent classes of mental health beliefs (Hahn et al., J Trauma Stress 34:394–404, 2020; low barrier, stigma-related beliefs, negative perceptions of care, high barrier), we examined associations with outpatient mental health care indicated by a provider as related to MST. Care was examined in total, as well as the specific categories of medication management, individual psychotherapy, and group psychotherapy.Key ResultsAccess to care following MST detection was high: most (71.6%) Veterans had an MST-related mental health visit within 30 days, and nearly all (83.6%) within 180 days, with the median number of days to receiving care being 2. Negative perceptions of care predicted a lower likelihood of treatment engagement (3+ encounters) with MST-related individual psychotherapy (OR = 0.65, 95% CI (0.43–0.96)), whereas the stigma-related beliefs and high barrier classes did not.ConclusionsThere appears to be excellent access to mental health care among Veterans with a perceived need for MST-related mental health treatment. However, treatment beliefs that represented negative perceptions of care may serve as barriers to engagement. Interventions targeting negative perceptions of care during early encounters could help promote subsequent engagement.

Factors associated with re-admission in the year after acute postpartum psychiatric treatment

PurposeTo examine factors associated with being re-admitted in the year after discharge from acute postpartum psychiatric treatment.MethodsSecondary data analysis of information collected from mothers who were admitted to acute psychiatric services in the year after childbirth between 2013 and 2017. We carried out univariable analyses and multivariable hierarchical logistic regression to examine risk factors for women’s re-admission to acute psychiatric care (inpatient or community crisis care) in the year following discharge.ResultsSixty-seven (24.1%) of 278 women were re-admitted in the year after discharge from acute care; the median number of days to re-admission was 86 (IQR 35–214), and women who were re-admitted accessed a median of two further acute services (IQR 1–3). In adjusted analyses, reporting a history of childhood trauma (aOR 1.02; 95% CI 1.00- 1.03, p = 0.036), a higher level of difficulties in the mother–infant bond (aOR 1.03; 95% CI 1.01–1.06, p = 0.009) and younger age (aOR 0.95; 95% CI 0.90–1.00, p = 0.066) were associated with re-admission.ConclusionThis study confirms that the role of childhood adverse experiences on mental health is relevant for outcomes in women experiencing acute postpartum psychiatric episodes. Ongoing parent–infant bonding difficulties are also independently associated with re-admission. Perinatal mental health services therefore need to offer evidence-based interventions to address histories of trauma and to support parent–infant bonding to optimise mental health in women following discharge from acute psychiatric services. However, further research is needed to explore what other factors, not measured in our study, are also influential to re-admission.

Intake assessments of salivary cortisol, survey responses, and adverse childhood experiences are associated with recovery success in an abstinence-based treatment program for substance use disorders.

Connecting patients to treatment for a substance use disorder (SUD) that satisfies their needs is often complicated by confounding factors. A reliable measurement of patients' underlying stress level may be helpful because it often reflects many of the same confounders as their SUD. Whereas cortisol levels reflect physiological responses to stress, patients' cortisol levels during recovery from an SUD may serve as biomarkers for stressors that result in poor treatment outcomes, including early discontinuation of treatment. However, further exploration of the relationship between patients' cortisol levels and their treatment outcomes is needed for this approach to be clinically useful. We enrolled participants from an abstinence-based, male-only, residential alcohol and drug recovery program to examine the relationship between salivary cortisol, stress exposure, ACEs, and treatment retention. Participants who remained in the program <90 days had significantly higher initial cortisol levels than those who remained ≥90 days (0.62 ± 0.074 μg/dl vs. 0.36 ± 0.037 μg/dl). Kaplan-Meier curves differed significantly when we grouped participants according to whether their cortisol level was below or above the overall average of 0.49 ± 0.044 μg/dl, with the median numbers of days before discontinuing being 110 and 60, respectively. A Cox proportional hazards model indicated that elevated salivary cortisol (with increases in μg/dl), marital/relationship status, andadverse childhood experiences (ACEs) score correlated significantly with hazards of discontinuing the program (hazard ratios for the three factors were 3.49, 2.39, and 1.50, respectively). Cortisol level may predict, at least partially, SUD treatment program retention regardless of individuals' numerous confounding factors or the substance used. If this approach is validated, it could enable providers to consider patients' cortisol levels at the time of admission to treatment to facilitate their retention in treatment and thereby enhance their recovery.

Endoscopic Ultrasound-Guided Antegrade Stent Placement in Patients with Failed ERCP as a Modality of Preoperative and Palliative Biliary Drainage.

No large studies have addressed the role of endoscopic-ultrasound biliary drainage (EUS-BD) as preoperative biliary drainage (PBD) for malignant extrahepatic biliary obstruction (MEBO). We aimed to discuss the outcomes of EUS antegrade stent placement (EUS-AG) in the preoperative and palliative setting. Retrospective review of patients who underwent EUS-AG for MEBO between December 2019 and December 2021 was done. Primary outcome measures were technical success and clinical success. Secondary outcome measures were number of days of hospitalization postprocedure, adverse events related to EUS-AG procedure, morbidity related to surgery, and 3-month mortality after surgery. 54 patients underwent attempt for EUS-AG (mean age 54.8 ± 12.1years; female 44.4%). Most common primary cancer was pancreatic cancer in 42.1% (23/54) patients. Indication was palliative in 34 (62.9%) patients and PBD in 20 (37%) patients. Level of block was distal in 35 (64.8%) and proximal in 19 (35.1%) patients. Technical success of EUS-AG was 88.7% (47/53). Clinical success was seen in 95.7% (45/47) patients. Median number of days of hospitalization postprocedure was 1day. No procedure-related severe adverse events were seen. Of 20 patients who underwent EUS-AG as PBD, 19 had technical success (95%) with clinical success in 94.5% (18/19). Surgery was performed in 11 patients, of whom 10 patients underwent successful PPPD (one intraoperative liver metastasis). Two patients had Clavein-Dindo III/IV complication post-PPPD, with one mortality within 30days of surgery. EUS-AG is safe and effective after failed ERCP in both preoperative and palliative setting.

Evaluating the effectiveness of using negative pressure wound therapy in the preservation of the infected prosthetic aortic graft

BackgroundInfected deep sternal infection due to an associated infection of the prosthetic aortic graft is a devastating condition. Standard management requires the removal of the graft and substituting it with a new one. Often, removal of the prosthetic graft is close to impossible. Negative pressure wound therapy is currently the treatment of choice for patients with deep sternal infection. However, its use in deep sternal infection with exposed infected prosthetic aortic graft has not been well described. MethodsEight patients were included in this study. All had type A aortic dissection of the ascending aorta and/or aortic arch. ResultsThere were 7 men and 1 woman. The median age was 53 years old (range 33–81 years old). The median number of days from the initial aortic operation to the diagnosis of infection was 20 days (range 14–52). The median length of stay in the intensive care unit was 17 days (range 6–338 days). The median time interval from the initial debridement to reconstruction was 20 days (range 6–43 days). The median number of times negative pressure wound therapy was changed was 4 (range 2–9). The most common flap used for reconstruction was the pectoralis major musculocutaneous flap in 7 patients, a free antero-lateral thigh flap in 1 patient, and pedicled omental flap in combination with pectoralis major musculocutaneous flap in 1 patient. One patient had persistent recurrent infection of the graft despite negative pressure wound therapy and flap reconstruction. The median length of follow-up was 38.5 months (range 4–120 months). ConclusionThis small study suggests that negative pressure wound therapy could be used successfully for the management of deep sternal infection due to infected prosthetic aortic grafts. In most cases, it eliminated the need to replace the infected prosthetic aortic graft in high-risk patients.

Dosage Frequency Effects on Treatment Outcomes Following Self-managed Digital Therapy: Retrospective Cohort Study.

BackgroundAlthough the efficacy of high-dose speech-language therapy (SLT) for individuals with poststroke aphasia has been established in the literature, there is a gap in translating these research findings to clinical practice. Therefore, patients continue to receive suboptimal amounts of SLT, with negative consequences for their functional communication recovery. Recent research has identified self-managed digital health technology as one way to close the dosage gap by enabling high-intensity therapy unrestricted by clinician availability or other practical constraints. However, there is limited empirical evidence available to rehabilitation professionals to guide dose prescriptions for self-managed SLT despite their increasing use in the COVID-19 era and likely beyond.ObjectiveThis study aims to leverage real-world mobile health data to investigate the effects of varied dosage frequency on performance outcomes for individuals with poststroke speech, language, and cognitive deficits following a 10-week period of self-managed treatment via a commercially available digital health platform.MethodsAnonymized data from 2249 poststroke survivors who used the Constant Therapy app between late 2016 and 2019 were analyzed. The data included therapy tasks spanning 13 different language and cognitive skill domains. For each patient, the weekly therapy dosage was calculated based on the median number of days per week of app use over the 10-week therapy period, binned into groups of 1, 2, 3, 4, or ≥5 days per week. Linear mixed-effects models were run to examine change in performance over time as a function of dosage group, with post hoc comparisons of slopes to evaluate the performance gain associated with each additional day of practice.ResultsAcross all skill domains, linear mixed-effects model results showed that performance improvement was significantly greater for patients who practiced 2 (β=.001; t15,355=2.37; P=.02), 3 (β=.003; t9738=5.21; P<.001), 4 (β=.005; t9289=7.82; P<.001), or ≥5 (β=.005; t6343=8.14; P<.001) days per week compared with those who only practiced for 1 day per week. Post hoc comparisons confirmed an incremental dosage effect accumulating with each day of practice (ie, 1 day vs 2 days, 2 days vs 3 days, and 3 days vs 4 days), apart from 4 days versus ≥5 days of practice per week. The result of greater improvement for higher versus lower dosage frequency groups was true not only across all domains but also within a majority of individual subdomains.ConclusionsThe findings from this study demonstrated that increased dosage frequency is associated with greater therapy gains over a 10-week treatment period of self-managed digital therapy. The use of real-world data maximizes the ecological validity of study results and makes the findings more generalizable to clinical settings. This study represents an important step toward the development of optimal dose recommendations for self-managed SLT.

Evaluation of an implementation strategy for Individual Placement and Support in the Netherlands: a 30-month observational study

BackgroundIndividual Placement and Support (IPS) is an evidence-based, effective approach to help people with severe mental illness (SMI) obtain and maintain competitive employment. The aim of the present study was to examine employment outcomes and associations with an organizational and a financial factor in people with SMI who participated in Individual Placement and Support using a multifaceted implementation strategy (IPS + MIS). The goal of this strategy was to improve IPS implementation by enhancing collaboration among mental health care and vocational rehabilitation stakeholders, and realizing secured IPS funding.MethodsAn observational cohort study including 103 participants was conducted, with a 30-month follow-up. Descriptive analyses were used to examine employment outcomes. Multivariable logistic and linear regression analyses were performed to study associations with an organizational and a financial factor: the level of experience of mental health agencies with providing IPS + MIS and the type of IPS funding (i.e. municipality funding (reference group) and the Dutch Social Security Institute: the Institute for Employee Benefits Schemes (UWV) funding).ResultsForty-six percent of the participants were competitively employed at any time during the 30-month follow-up; the median number of days until competitive job obtainment and in competitive jobs was 201 and 265, respectively. The majority of all jobs obtained (81%) were categorized as ‘elementary occupations’, ‘clerical support workers’, and ‘service and sales workers’. A higher level of experience of the mental health agencies with providing IPS + MIS was found to be positively associated with job obtainment (OR = 3.83, 95% CI 1.42–10.30, p = 0.01) and the number of days worked in competitive jobs (B = 1.21, 95% CI 0.36–2.07, p = 0.01). UWV funding was found to be negatively associated with job obtainment (OR = 0.30, 95% CI 0.11–0.77, p = 0.01). No association was found for the type of IPS funding and the number of days worked in competitive jobs (B = -0.73, 95% CI -1.48–0.02, p = 0.06).ConclusionsThis study shows that almost half of the people who participate in IPS + MIS obtain a competitive job within 30 months. The results further suggest that both the level of experience of mental health agencies with providing IPS + MIS, and funding may play a role in employment outcomes.

Factors Associated with Delayed Diagnosis among Patients with COVID-19 in Okinawa, Japan

The delayed presentation and diagnosis of COVID-19 can contribute to spread of the disease to others but can also cause severe conditions. This study examined factors associated with delayed diagnosis among patients with COVID-19 in Okinawa, Japan. We used the data from 7125 reported cases of people living in Okinawa prefecture with symptom onset between September 2020 and March 2021. The outcome variable was the number of days from symptom onset to diagnosis. The predictor variables included age, sex, occupation, residential area, presumed infection route, and the day of the week. Cox regression analysis was used to compare the outcome between categories for each predictor variable. The median number of days from onset to diagnosis was 3 days, with an interquartile range of 1 to 5 days. Significantly more time from onset to diagnosis was observed in patients in their 60s vs. those in their 20s (hazard ratio: 0.88; 95% confidence interval: 0.81–0.96); hospitality workers were compared to office workers (0.90; 0.83–0.97), patients with unknown infection routes to those with known infection routes (0.77; 0.70–0.84), and those with symptom onset on Sundays/national holidays to those with symptom onset on weekdays (0.90; 0.85–0.96).

Naturalistic study on the use of clozapine in the early phases of non-affective psychosis: A 10-year follow-up study in the PAFIP-10 cohort

Clozapine is seldom prescribed in treatment-resistant schizophrenia (TRS) patients during early phases of the illness. We aimed to examine the pathway and patterns and the impact of clozapine use in patients with TRS who were followed up for 10 years after the first outbreak of the illness. Data were obtained retrospectively from an epidemiological cohort of first episode schizophrenia patients (n = 218) who had been treated in a specialized intervention program (PAFIP). Out of 218, 35 (16%) individuals were on clozapine at 10-year assessment, while 183 (84%) were taking other antipsychotics. Among those 183 psychosis subjects who were not on clozapine, 13 (7.1%) met criteria for TRS. In the clozapine group, ten (28.6%) met criteria for early-TR and twenty-five (71.4%) met criteria for late-TR. Before clozapine treatment was initiated, the median number of days under other antipsychotic treatment was 1551 days (IQR = 1715) and the median time that subjects remained on clozapine was 6.3 years (IC95%: 5.49–7.20). At 10 years, we found that those individuals taking clozapine had higher CGI total scores (F = 12.0, p = 0.001) and SANS total scores (F = 9.27, p = 0.003) than subjects taking other antipsychotics after correcting for baseline values. Interestingly, when performing these analyses at 10 years between subjects taking clozapine (n = 35) and subjects who despite meeting TRS criteria were not taking clozapine (n = 13), we found that subjects taking clozapine had significantly lower total scores on all clinical scales compared with subjects who met TRS criteria and were not taking clozapine (p values < 0.05). TRS patients who took the longest time to start clozapine (third tertile) showed significantly higher CGI scores at 10-year follow-up compared to those who initiated clozapine earlier (first tertile) (t = 2.60; p = 0.043). Our findings reinforce the need of a timely assessment of treatment-resistant criteria in early schizophrenia patients and highlight the long-term benefits of an early introduction of clozapine on those patients meeting treatment-resistant criteria.

Extracorporeal Membrane Oxygenation in Pediatric Burn Patients Without Inhalation Injury: A Unique Population?

Prolonged mechanical ventilation (MV) before the initiation of extracorporeal membrane oxygenation (ECMO) is associated with decreased survival. Pediatric burn patients without inhalational injury are a unique population as they may be intubated for longer durations due to frequent interventions such as dressing changes and burn excisions. This study utilized the Extracorporeal Life Support Organization registry and evaluated patients 0 to 18 years old placed on ECMO and with a burn injury from January 2010 to December 2020. Inhalation injury was excluded. Descriptive statistics and bivariate analyses were performed. Multivariable logistic regression was used to assess the association between mortality and precannulation MV duration before ECMO cannulation, and odds ratios and predicted probabilities of mortality were estimated. Our cohort of 47 patients had a median age of 2.7 years old. Mortality occurred in 48.9% of the cohort. The overall median number of days on ECMO was 6.3 days, with no difference between survivors and non-survivors (6.8 days vs 6.3 days; P = .67). Survivors were ventilated for 4.1 days and non-survivors for 4.8 days before cannulation (P = .25). Regression modeling demonstrated that with each additional day on MV before ECMO cannulation, the odds of mortality increases by 12% (P = .03). Our study suggests that, similar to pediatric patients without thermal injury, increasing precannulation MV duration is associated with an increasing risk of mortality in pediatric burn patients without inhalational injury. Though the pediatric burn population is unique, evaluation of burn patients with respiratory failure for ECMO should be similar to the general population.

Rates and patterns of physical activity among Hispanics with multiple sclerosis in the NARCOMS Registry

BackgroundMultiple sclerosis (MS) is the most common cause of non-traumatic neurological disability among adults with an estimated incidence of 2.9 cases per 100,000 Hispanic adults. Hispanics with MS experience disproportionate rates of mobility disability compared to non-Hispanic Whites with MS. The current study aimed to examine the rates and patterns of physical activity (PA) behavior among Hispanics with MS and compare physical activity behavior to non-Hispanic Whites with MS in the North American Research Committee on Multiple Sclerosis Registry (NARCOMS). MethodsNARCOMS registry participants who completed the physical activity questions in the Spring 2015 semi-annual survey were included in the analyses. Self-identified Hispanic and non-Hispanic Whites were compared. Rates and patterns of physical activity were based on the International Physical Activity Questionnaire. We performed a 2:1 propensity score matching for comparing non-Hispanic White and Hispanic participants. ResultsOf the 6,352 NARCOMS participants in Spring 2015, we included 136 Hispanic and 6,216 non-Hispanic White participants. Among the Hispanic sample, median number of days engaged in vigorous PA was 0 and moderate PA was 1 day. Mean number of minutes sitting per day was 531±266 (approximately 9 hours). Further, a minority of Hispanic participants classified themselves as moderate or heavy active for work (11%), home (24%), and leisure (33%) physical activity. There were no significant differences between participants who identified as Hispanic (n=119) and propensity-matched non-Hispanics White participants (n=238) in demographics, clinical characteristics, or physical activity variables. ConclusionRates of physical activity were low among Hispanics with MS. This highlights an opportunity for examining the impact of physical activity interventions for improving mobility disability.

Pulmonary Barotrauma in COVID-19 Patients: Experience From a Secondary Care Hospital in Oman.

BackgroundDuring the COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), many patients developed pulmonary barotrauma either self-inflicted or ventilator-induced. In pulmonary barotrauma, air leaks into extra-alveolar tissue resulting in pneumomediastinum, subcutaneous emphysema, pneumothorax, and pneumoperitoneum.MethodsAfter obtaining institutional approval, we retrospectively reviewed data from March 1, 2021, to September 31, 2021. Being a retrospective study, informed consent was not applicable. Patient data were collected from the Al Shifa patient information portal, which is an electronic medical record system available to all hospitals in the Ministry of Health, Oman. After identifying patients with pulmonary barotrauma, the following details were recorded and entered into an Excel sheet (Microsoft Corporation, Albuquerque, New Mexico) and a database was created, which contained the following: age, sex, smoking history, comorbidities, type, location, mode of barotrauma, mode of ventilation, length of intensive care unit (ICU) stay, interventions performed, and overall outcome (survived/deceased).ResultsA total of 529 patients with COVID-19 pneumonia were admitted from March 2021 to September 2021 to the ICU. Twenty-eight patients developed barotrauma of variable severity and required interventions like the placement of intercostal drains. Out of 28, five patients developed spontaneous barotrauma, 14 patients had barotrauma after initiation of non-invasive ventilation, and nine patients had barotrauma as a result of invasive ventilation. The median number of days in the ICU was 19.5 (interquartile range: 12.5-26.5). Of the 28 patients, eight patients survived and were discharged from the hospital.ConclusionIn this single-center, retrospective study at a secondary care hospital in Oman, we described our experience with patients who suffered pulmonary barotrauma during their ICU admission. We have also presented the incidence of spontaneous versus ventilator-induced barotrauma, the length of stay of these patients, the outcomes in terms of survival or death, the need for tracheostomy, secondary infections, and interventions performed as indicated.

P1187: END OF TREATMENT 18F FDG-PET/CT RESPONSE IS PROGNOSTIC FOR OVERALL AND PROGRESSION-FREE SURVIVAL IN PERIPHERAL T-CELL LYMPHOMA: RESULTS OF THE UK NCRI PHASE 2 RANDOMISED CHEMO-T TRIAL PET/CT SUBSTUDY

Background: The role of 18F FDG PET (PET) in peripheral T-cell lymphoma (PTCL) remains under evaluation. The UK NCRI phase 2 randomised CHEMO-T trial compared cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP) with gemcitabine, cisplatin and methylprednisolone (GEM-P) in previously untreated PTCL patients. The primary endpoint, to demonstrate a superior complete response (CR) rate for GEM-P by contrast-enhanced CT (CECT) at end of treatment (EOT) was not met. Aims: To investigate the role of PET in determining baseline bone marrow (BM) involvement in PTCL and as a prognostic tool at EOT. Methods: Patients required a baseline PET (acquired as per protocol) within 28 days of randomisation and a PET at EOT at least 28 days post chemotherapy. Site accreditation, data collation, and quality control for PET imaging was performed by the UK PET Core Lab. BM biopsy was required within 6 weeks of randomisation. PET scans were centrally reviewed at The Royal Marsden by 2 expert nuclear medicine physicians (YD and NH). Baseline BM involvement by PTCL on PET was evaluated. PET response was assessed according to the revised response criteria for malignant lymphoma and by the Deauville score (DS) 5-point scale. Where discordance existed between reviewers, a third reviewer (SC) adjudicated. EOT PET response and PET status (DS 1-3=PET-negative, DS 4-5=PET-positive) were correlated with PFS and OS. Results: Baseline PET data was available for 82/84 patients, 80/82 (98%) had FDG-avid disease (n=2 with non-avid disease (n=1 AITL, n=1 EATL) were excluded). Clinical characteristics were similar to the main trial cohort: median age=63 yrs, male=73% and high-risk IPI=23%. PTCL subtypes were AITL n=33 (41%), PTCL-NOS n=32 (40%), ALK- ALCL n=14 (18%) and EATL n=1 (1%). For 20/79 (25%) patients with biopsy-proven BM infiltration 9/19 (47%) had BM uptake on baseline PET. Of 20/80 patients (25%) with BM uptake on baseline PET, 9/20 (45%) had biopsy-confirmed infiltration. PET had a sensitivity of 47% and a specificity 81% for determination of BM involvement. EOT PET was available for 69/80, n=4 were excluded as data was acquired following a later line (n=3) or complete imaging was not retrievable (n=1); therefore 65/80 had evaluable EOT PET data. The median number of days from EOT to PET was 41. At EOT, PET response was CR n=41 (63%), partial response (PR) n=15 (23%), stable disease n=0 and progressive disease (PD) n=9 (14%); 41 (63%) were PET-negative and 24 (37%) were PET-positive. At a median follow-up of 27 months, PET-negative vs. PET-positive patients at EOT had a 2-yr OS of 72% vs. 52% [HR 0.58; 95% CI 0.24–1.41), p=0.231] and 2-yr PFS of 55% and 29% [HR 0.45 (95% CI 0.23–0.88), p=0.021] respectively. EOT PET response correlation with 2-yr OS was CR=72%, PR=67%, PD=29%; and with 2-yr PFS was CR=55%, PR=32%, PD=25%. A CR by PET (vs. PD) was associated with improved OS [HR 0.245 (95% CI 0.083–0.730), p=0.012] (Figure 1) and PFS [HR 0.265 (95% CI 0.102–0.687), p=0.006]. Adjusting for stratification parameters at randomisation (IPI risk group, PTCL subtype) PET response remained prognostic for both OS and PFS while EOT PET status (positive vs. negative) did not. CECT response remained prognostic for PFS only. Image:Summary/Conclusion: Our findings indicate that PET has insufficient sensitivity for detection of BM involvement for baseline staging. Furthermore, while both EOT CECT and PET response were prognostic for PFS and OS, only PET response remained prognostic for OS following adjustment for stratification factors suggesting it is a superior prognostic tool in PTCL.

Search for a time- and cost-saving genetic testing strategy for maturity-onset diabetes of the young.

AimsCorrect genetic diagnosis of maturity-onset diabetes of the young (MODY) is beneficial for person’s diabetes management compared to no genetic testing. Aim of the present study was a search for optimal time- and cost-saving strategies by comparing two approaches of genetic testing of participants with clinical suspicion of MODY.MethodsA total of 121 consecutive probands referred for suspicion of MODY (Group A) were screened using targeted NGS (tNGS), while the other 112 consecutive probands (Group B) underwent a single gene test based on phenotype, and in cases of negative findings, tNGS was conducted. The study was performed in two subsequent years. The genetic results, time until reporting of the final results and financial expenses were compared between the groups.ResultsMODY was confirmed in 30.6% and 40.2% probands from Groups A and B, respectively; GCK-MODY was predominant (72.2% in Group A and 77.8% in Group B). The median number of days until results reporting was 184 days (IQR 122–258) in Group A and 91 days (44–174) in Group B (p < 0.00001). Mean costs per person were higher for Group A (639 ± 30 USD) than for Group B (584 ± 296 USD; p = 0.044).ConclusionsThe two-step approach represented a better strategy for genetic investigation of MODY concerning time and costs compared to direct tNGS. Although a single-gene investigation clarified the diabetes aetiology in the majority of cases, tNGS could reveal rare causes of MODY and expose possible limitations of both standard genetic techniques and clinical evaluation.Supplementary InformationThe online version contains supplementary material available at 10.1007/s00592-022-01915-x.

Abstract CT115: Safety and efficacy of Anti-PD-L1 antibody MEDI4736 (durvalumab) in combination with capecitabine in patients with advanced solid tumors (DURVA+)

Abstract Background: It is hypothesized that chemotherapy alters the tumor microenvironment (TME) by increasing T cell infiltration and enhancing antigen presentation to T cells, and thereby may enhance immune-mediated cytotoxicity and tumor response to immunotherapy. The goal of this trial (DURVA+) is to evaluate and compare the immune-modulating effects of six different chemotherapy agents with Durvalumab (D), a PD-L1 checkpoint inhibitor. We report here the first analysis of one of the arms of DURVA+: D plus capecitabine (C). Methods: This is a non-randomized phase 2 trial for adult patients (pts) with refractory advanced solid tumors. Pts received C at a dose of 1250 mg/m2 bid on days 1-14 of 21-day cycle. For the first 3 cycles, D is administered every 2 weeks at a dose of 750 mg IV starting on C1D8. From cycle 4 onwards, D was given at a dose of 1125 mg IV every 3 week (day 1 of each 21-day cycle). Tumor biopsies were required at baseline, C1D8 (prior to durvalumab), C3D8, and optional at progression. Radiologic tumor assessment occurs every 4 cycles by RECIST. iRECIST is assessed as a secondary endpoint. Baseline and at least one on-treatment biopsy were obtained for 11 patients, at least 8 of which are evaluable for pharmacodynamic (PD) response (treatment-induced changes in immune cell tumor content and function). Results: As of Nov 10, 2021, 14 pts were enrolled to this arm. Median age 57 (range 31-73 years), 7 males and 7 females, 4 black, 8 white, 2 unknown race. Majority of pts had colorectal carcinoma (ca) (n=8), other include (n=1 each): appendiceal, anal squamous cell ca, leiomyosarcoma, pancreatic ca, breast ca, and nasopharyngeal squamous cell ca. Median lines of prior treatment was 3.5 (1-13), 4 pts previously received ICI. Median number of days on study treatment were 83 days. One pt experience partial response (breast) and five pts experienced SD (3 colon, 1 pancreatic, 1 non-uterine leiomyosarcoma) for a median duration of 136 days as of Jan 3, 2022 (data cutoff); one pt with pancreatic ca experienced a 27% reduction in sum of target lesions. Treatment related adverse events (TrAE) of all grades occurred in 13 pts, serious TrAEs (more than grade 2) occurred in 8 pts and included anemia, pulmonary embolism, hyperbilirubinemia, palmar plantar syndrome, neutropenia, lymphopenia and diarrhea. Immune-mediated AEs included transaminitis/hepatitis (n=4, all grade 1/2), hypothyroidism (n=2, grade 1/2), rash (n=1, grade 1) and colitis (grade 3). PD studies are still ongoing. Conclusion: The combination of durvalumab with capecitabine is feasible with no unexpected adverse events. PD assessment is ongoing to examine the hypothesis that chemotherapy alters tumor micronenvironment (TME) and T cell activation. The study was sponsored by NCI, and was funded in part by NCI Contract HHSN261200800001E. DURVA+ is registered with ClinicalTrials.gov, NCT03907475. Citation Format: Mohamad Adham Salkeni, Geraldine O’Sullivan Coyne, Naoko Takebe, Elad Sharon, Howard Streicher, Jessica Mukherjee, Ashley Bruns, Arjun Mitra, Abdul R. Naqash, Larry Rubinstein, Kristin K. Fino, King L. Fung, Katherine Ferry-Galow, Ralph Parchment, Helen Chen, James Doroshow, Alice Chen. Safety and efficacy of Anti-PD-L1 antibody MEDI4736 (durvalumab) in combination with capecitabine in patients with advanced solid tumors (DURVA+) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr CT115.

Are Formal Voiding Trials Necessary After Posterior Compartment Reconstructive Surgery?

Posterior compartment surgery is considered a risk factor for postoperative urinary retention because of the impact of postoperative pain on the pelvic floor; however, few studies have examined the association between posterior compartment reconstructive surgery and urinary retention. The aim of the study was to compare rates of urinary retention in patients undergoing vaginal reconstructive surgery, without hysterectomy, in the posterior compartment only versus any apical and/or anterior compartment (with or without posterior compartment). In this retrospective cohort study, we evaluated patients who underwent surgery, without hysterectomy, in the posterior compartment only versus any apical and/or anterior compartment (with or without posterior compartment) from January 2015 to November 2020. Our primary outcome was rate of postoperative urinary retention, defined as a failed voiding trial before discharge. Secondary outcome was days of catheterization. Multivariable logistic regression was performed to assess variables associated with a failed voiding trial. Of 362 patients, 141 (39.0%) underwent surgery in the posterior compartment only and 221 (61.0%) underwent vaginal apical and/or anterior compartment surgical procedures. Rate of retention was significantly lower in the posterior compartment only group (9.9% vs 41.6%, P < 0.001). The median numbers of days of catheterization were significantly fewer in the posterior compartment only group (0 [0,0] vs 0 [0,3], P < 0.001). In multivariable logistic regression, posterior compartment only surgery was associated with passing the voiding trial (odds ratio, 6.0; 95% confidence interval, 2.97-12.03). Rates of postoperative urinary retention after surgery in the posterior compartment are low, and these patients may not require formal voiding trials after surgery.

Metabolic Alterations in Sputum and Exhaled Breath Condensate of Early Stage Non-Small Cell Lung Cancer Patients After Surgical Resection: A Pilot Study

Every year, close to two million people world-wide are diagnosed with and die of lung cancer. Most patients present with advanced-stage cancer with limited curative options and poor prognosis. Diagnosis of lung cancer at an early stage provides the best chance for a cure. Low- dose CT screening of the chest in the high-risk population is the current standard of care for early detection of lung cancer. However, CT screening is invasive due to radiation exposure and carries the risk of unnecessary biopsies in non-cancerous tumors. In this pilot study, we present metabolic alterations observed in sputum and breath condensate of the same population of early- stage non-small cell lung cancer (NSCLC) patients cancer before and after surgical resection (SR), which could serve as noninvasive diagnostic tool. Exhaled breath condensate (EBC) (n=35) and sputum (n=15) were collected from early-stage non-small cell lung cancer (NSCLC) patients before and after SR. Median number of days for EBC and sputum collection before and after SR were 7 and 42; and 7 and 36 respectively Nuclear magnetic resonance (NMR) and liquid chromatography quadrupole time-of-flight mass spectrometry (LC-QTOF-MS) were used to analyze the metabolic profile of the collected samples. A total of 26 metabolites with significant alteration post SR were identified, of which 14 (54%) were lipids and 12 constituted nine different chemical metabolite classes. Eighteen metabolites (69%) were significantly upregulated and 8 (31%) were downregulated. Median fold change for all the up- and downregulated metabolites (LC-QTOF-MS) were 10 and 8, respectively. Median fold change (MFC) in concentration of all the up- and downregulated metabolites (NMR) were 0.04 and 0.27, respectively. Furthermore, glucose (median fold change, 0.01, p=0.037), adenosine monophosphate (13 log fold, p=0.0037) and N1, N12- diacetylspermine (8 log fold p=0.011) sputum levels were significantly increased post-SR. These identified sputa and EBC indices of altered metabolism could serve as basis for further exploration of biomarkers for early detection of lung cancer, treatment response, and targets for drug discovery. Validation of these promising results by larger clinical studies is warranted.

Time to biopsy of screening mammography-detected abnormalities: Evaluating the impact of same-day services implemented during the COVID-19 pandemic.

1511 Background: Screening mammography programs often require patients undergo multiple visits (screening exam, diagnostic exam, and biopsy) before tissue diagnoisis of screen-detected abnormalities. During the COVID-19 pandemic, same-day breast imaging services were leveraged to decrease the number of visits following abnormal screening exams. Specifically, in May 2020, we implemented an immediate-read screening mammography program to synergize with our pre-existing same-day breast biopsy program, such that every effort was made to perform diagnostic imaging during the same visit after an abnormal screening mammogram. This study aims to evaluate the impact of these same-day breast imaging services on time and number of patient visits to undergo breast biopsy after an abnormal screening mammogram. Methods: Consecutive screening mammograms performed during normal business hours pre- (6/1/16 to 5/30/17) and post-implementation (6/1/20 to 5/30/21) of same-day services were identified. Patient demographics, imaging and biopsy results, and visit dates were extracted from the medical record. Multivariable logistic, linear, and ordinal regression models estimated with generalized estimating equations were fit to assess the association of period (pre- versus post-implementation), patient age, and race and ethnicity (White versus races other than White) with having a same-day biopsy (biopsy on the same day as the abnormal screening exam), number of days to biopsy, and number of visits. Adjusted odds ratios (aOR) and beta estimates (aBeta) of each covariate and corresponding 95% confidence intervals (CI) were estimated. Results: A total of 409/25,922 (1.6%) of patients (median age 61, IQR 50-70) pre-implementation and 221/20,452 (1.1%) patients (median age 62, IQR 49-71) post-implementation had screen-detected abnormalities leading to diagnostic breast imaging and biopsy. Median number of days from screening to biopsy decreased from 16 days pre-implementation to 5 days post-implementation (p &lt; 0.001). Pre-implementation, 86.8% of patients required 3 visits between screening and biopsy, while post-implementation only 23.1% required 3 visits (p &lt; 0.001). Compared to pre-implementation, the post-implementation period was associated with increased odds of undergoing same-day biopsy (aOR 20.7, 95% CI 8.3-51.7), p &lt; 0.001), fewer days from abnormal screening mammogram to biopsy (aBeta -13.3, 95% CI -15.7 to -10.9, p &lt; 0.001), and fewer visits (aOR 0.05, 95% CI 0.02-0.09), p &lt; 0.001), controlling for age and race and ethnicity. Conclusions: Same-day breast imaging services decreased time and patient visits between abnormal screening mammogram and breast biopsy. Same-day services implemented out of necessity during the COVID-19 pandemic should be continued after the pandemic has subsided to improve timeliness of care.