Retrospective Patient Chart Research Articles

The Role of the Integrated District Hospital Based Non Communicable Diseases' Clinics in Cardiovascular Disease Control: Preliminary Data from Rwanda.

IntroductionNoncommunicable diseases (NCDs), remain the leading cause of death worldwide and represent an emerging global health threat. In Rwanda and elsewhere, the prevalence of cardiovascular diseases is increasing. To address this global health threat, Rwanda launched integrated nurse-led NCD clinics in all the forty-five District Hospitals across the country in 2006, but no evaluation study has been conducted so far for the added value of this program. The main goal of this study was to assess the impact of NCD clinics on disease control in Rwanda.MethodsThis was a retrospective ambulatory patient chart review at a rural district hospital and an urban teaching hospital; which enrolled patients with diabetes and/or hypertension who consulted in a period of 1 month with retrospective data of one year.ResultsA total of 199 patients’ electronic health records were reviewed from the University Teaching Hospital of Kigali (CHUK) (53%) and Nyamata District Hospital (47%). Among them, 31% had diabetes, 38% had hypertension and 31% had both diseases. The mean age for the total cohort was 60 years and was predominantly female at 70%. Throughout the year, about 59% patients with hypertension had blood pressure control at the district hospital as opposed to 38% at the referral hospital. The rate of diabetes control was 20% at the referral hospital, but no comparison could be established between the two health facilities as the follow up laboratory markers were not available at the district hospital.ConclusionThere was a consistent blood pressure control at the district hospital. Diabetes control was not optimal at the referral hospital despite the presence of human resources and logistics required for diabetes care. The situation was even worse at the district hospital where the follow up markers were rarely available.

Treatment patterns and real-world clinical outcomes in patients with advanced endometrial cancer that are non-microsatellite instability high (non-MSI-high) or mismatch repair proficient (pMMR) in the United States

ObjectiveMicrosatellite instability (MSI) due to defective DNA mismatch repair has emerged as an actionable biomarker in advanced endometrial cancer (aEC). Currently, there are no treatment patterns and outcomes data in non-MSI-high (non-MSI-H) or mismatch repair proficient (pMMR) aEC patients following prior systemic therapy (FPST). Our goal was to describe real-world data in this population in the US in 2019 and prior years. MethodsEndometrial Cancer Health Outcomes (ECHO) is a retrospective patient chart review study conducted in the US. Patients with non-MSI-H/pMMR aEC and progression between 06/01/2016–06/30/2019 FPST were eligible. Data collected included patient demographics, clinical and treatment characteristics, and clinical outcomes. Kaplan-Meier analyses were performed to estimate time to treatment discontinuation, real-world progression-free survival (rwPFS), and overall survival (OS), separately by treatment category. ResultsA total of 165 eligible patients initiated second-line therapy with chemotherapy ± bevacizumab (n = 140) or hormonal therapy (n = 25). Median age was 66.0 years at aEC diagnosis, 70.2% were Stage IIIB-IV, 40.0% had ECOG ≥ 2 at second-line therapy initiation. Median rwPFS was 5.0 months (95% CI: 4.0–6.0) for patients receiving chemotherapy ± bevacizumab and 5.5 months (95% CI: 3.0–29.0) for those receiving hormonal therapy. Median OS was 10.0 months (95% CI: 8.0–13.0) and 9.0 months (95% CI: 6.0-NA) in these groups, respectively. ConclusionsNon-MSI-H/pMMR patients who initiated second-line therapy with chemotherapy ± bevacizumab or hormonal therapy had poor clinical outcomes with a median survival less than 1 year and rwPFS less than 6 months. This was the first study to define the clinical unmet need in patients with non-MSI-H/pMMR aEC with conventional therapy.

On the recovery of disorders of consciousness under intrathecal baclofen administration for severe spasticity-An observational study.

BackgroundOccasionally, patients show dramatic recovery from disorders of consciousness (DOC) under intrathecal baclofen (ITB), an established treatment option for severe supraspinal spasticity. Anecdotal explanations for ITB‐related recovery of cognition include modulation of afferent impulses at the spinal level, thereby reducing spasticity‐related proprioceptive information overload within cortico–thalamo–cortical connections.ObjectiveIn this retrospective patient chart analysis, we assessed whether a reduction in spasticity would be associated with an increase in Coma Recovery Scale revised (CRS‐R) scores in a larger sample of patients than previously published.MethodsFrom a hospital‐based ITB treatment register, we extracted data from 26 patients with DOC and severe supraspinal spasticity who improved by >2 points on the Coma Recovery Scale revised (CRS‐R) within 6 months after ITB treatment initiation. We assessed Modified Ashworth scale (MAS) scores and CRS‐R scores on admission (PRE) and 3 and 6 months after initiation of ITB treatment (3M, 6M). We performed correlation analysis of the scores and their respective changes (PRE to 3M, 3M to 6M). We also correlated the time from acute event until ITB initiation to CRS‐R scores at 3M and 6M.ResultsITB led to significant improvement in spasticity based on MAS scores, which did not correlate to the improvements seen in CRS‐R total and subscale scores. Daily ITB dose did neither correlate to MAS scores nor to CRS‐total scores in the whole patient group, but after 3 months, ITB dose correlated to some CRS‐R subscale scores in some patient subgroups. Time until ITB treatment did not correlate to CRS‐R scores later on.ConclusionsOur data confirm that ITB may exert beneficial effects in selected DOC patients with respect to improved cognitive functions, which, however, do not correlate to its antispastic effect. The lack of correlation between time to ITB and CRS‐R outcome, but significant CRS‐R improvements following pump implantation, renders spontaneous remissions unlikely and leaves room for alternative pharmacological mechanisms.

Towards a pituitary apoplexy classification based on clinical presentation and patient journey

PurposeThe condition of pituitary apoplexia contains the clinical spectre from life-threatening emergency to asymptomatic self-limiting course, which partly determines diagnostic delay and management. Outcome evaluation of course and management of pituitary apoplexia is hampered by the diverse presentation of this condition and requires appraisal. This study aimed to describe the patient journey, clinical presentation, and management of various types of pituitary apoplexy in a new classification to facilitate future outcome evaluation and identify unmet needs in the care process.MethodsA single-center retrospective patient chart study was conducted between 2005–2021 (N = 98). Outcome measures were clinical symptoms at first presentation in hospital, being headache, consciousness, visual acuity, visual field defects (VFD), ophthalmoplegia, nausea, vomiting, fever, and hypopituitarism and care process characteristics.ResultsMean age was 47.6 ± 16.6 years (51.0% male). We describe their patient journey and identified three different types, differing in clinical presentation, in-hospital route, and final treatment, e.g., Acute (type A, 52%), Subacute (type B, 22.5%), and Non-acute (type C, 25.5%). Type A generally presents with acute onset headaches, VFD, or ophthalmoplegia emergency setting, with lowest mean visual acuity of both eyes and frequent hypocortisolism.ConclusionsPituitary apoplexy can be approached as a spectrum of disease with 3 main subtypes, with a different initial presentation, different in-hospital route resulting in different management. Acknowledging subtypes with particular needs for (emergency) referrals to Pituitary Tumors Center of Excellence (PTCOE) will serve patient care improvements, outcome evaluations and address areas for improvement.

Anterior circulation large vessel occlusion outcomes in patients transferred from a peripheral primary stroke centre

ABSTRACT Objectives To identify predictors of functional outcome in patients with an anterior circulation large-vessel occlusion (LVO) in a setting of long transfer distances. Methods Outcomes of LVO patients transferred for an endovascular thrombectomy (EVT) from North Karelia Central Hospital to Kuopio University Hospital between January 2018 and October 2019 were analysed using retrospective patient chart review. Results Three months after the stroke, modified Rankin Scale (mRS) was 0–2 in 20 of the 41 transferred patients. They were younger (66.7 vs. 74.2 years, p = 0.032) and had less severe stroke symptoms (National Institutes of Health Stroke Scale, NIHSS, 11.5 vs. 16.5, p = 0.029) than those with mRS 3–6. They also had the occlusion less often in M1 and more often in M2. EVT was performed in 32 patients (no differences between those treated with EVT and those not treated with EVT). Their median age was 73.0 years (interquartile range 65.5, 79.8; range 32–86; 25% over 80), mean NIHSS score 14.0 (standard deviation 5.9) and mRS eventually 0–2 in 44%. Only NIHSS was associated with mRS (OR = 1.16; p = 0.016) in the EVT-treated patients. mRS was 0 in 38% of all EVT-treated octogenarians but 4–6 in 83% of those with an internal carotid artery and/or M1 occlusion. Discussion Outcomes depended on stroke severity, age and vessel of occlusion. Prognosis was worse if the occlusion included M1, especially in octogenarians. Mothership and Drip-n-ship strategies should be compared in patients from remote locations stratified by stroke severity and patient age.

Discontinuation Due to Toxicity Limits Treatment Duration of BTK Inhibitors in Non-Hodgkin Lymphoma

Background: Although clinical trial data exist describing the adverse effects of Bruton's tyrosine kinase inhibitors (BTKi)s, the patient experience outside clinical trials, including differences among agents is less well-described. We evaluated the selection criteria, efficacy and toxicities related to the use of BTKi at our site.Methods: A retrospective patient chart review was used to collect data from patients treated with one or more BTKi. Demographics, prior therapies, duration of treatment, response to treatment, and incidence and severity of pre-determined toxicities of interest were collected for each patient. Descriptive statistics for each variable were reported. Association between variables of interest and the study cohort were examined using ANOVA for categorical variables and Pearson correlation coefficient for continuous variables. Survival and duration of treatment were estimated using the Kaplan-Meier method according to first novel agent. Survival analysis for each novel agent was conducted using Cox proportional hazards models and log-rank tests.Results: One hundred forty patients were included in this study, including 94 patients with CLL, 24 with MCL, and 22 with other NHL subtypes. One hundred thirteen patients received ibrutinib, while 17 patients received acalabrutinib (n=16) or zanubrutinib (n=1), which were combined in the statistical analysis. Of patients receiving ibrutinib, 69% reported at least one toxicity event during the duration of their treatment. Across all patients who received ibrutinib, 35 individuals did not report a toxicity, 48 individuals reported one toxicity, and 30 individuals reported two or more toxicities. Among the 78 patients who experienced at least one toxicity, 41 (52.5%) discontinued the medication due to these adverse effects, most commonly cytopenias (n=9), diarrhea (n=8), and fatigue (n=9). 57% of patients who reported diarrhea, 36% of patients who reported cytopenias, and 33% of patients who reported fatigue discontinued therapy due to that reported AE. In total, 60/113 patients receiving ibrutinib discontinued therapy, including 40 (66%) due to toxicity and 14 (23.3%) due to disease progression. The remaining patients discontinued therapy due to voluntary choice of new therapy or due to personal decision to stop treatment. Patients remained on ibrutinib therapy for a median duration of 40 months. 53% of patients taking zanabrutinib or acalabrutinib reported at least 1 toxicity, but only 11.7% of patients discontinued therapy for any reason. All patients who discontinued zanubrutinib/acalabrutinib therapy did so due to toxicity, with no patients ceasing therapy due to disease progression. Because only 2 of 17 patients discontinued zanubrutinib/acalabrutinib treatment, a raw median duration of treatment was calculated to be 5 months. 12.4% of patients taking ibrutinib experienced a gastrointestinal toxicity, whereas 5.9% of patients taking acalabrutinib/zanubrutinib experienced a gastrointestinal toxicity (Table 1). Additionally, 8% of individuals taking ibrutinib reported a musculoskeletal toxicity, while no acalabrutinib/zanubrutinib patients reported a musculoskeletal toxicity. There were no statistically significant differences in frequency of toxicities encountered, possibly due to study size. Other toxicities common to all analyzed BTK inhibitors included hematological, cardiovascular, and constitutional adverse effects with no significant difference between agents.Conclusions: We identified that >1/3 of individuals taking BTK inhibitors are stopping therapy prematurely due to toxicity related outcomes rather than due to disease progression. Our findings suggest that proactive identification and management of adverse effects could prolong therapy duration and provide better outcomes for patients. Strategies to personalize therapy selection to limit therapy discontinuation due to toxicity are needed as additional targeted agents are developed. [Display omitted] DisclosuresValla: BeiGene: Speakers Bureau. Cohen: Janssen, Adaptive, Aptitude Health, BeiGene, Cellectar, Adicet, Loxo/Lilly, AStra ZenecaKite/Gilead: Consultancy; Genentech, Takeda, BMS/Celgene, BioInvent, LAM, Astra Zeneca, Novartis, Loxo/Lilly: Research Funding.

P148 Solriamfetol Titration & AdministRaTion (START): Dosing and titration strategies in patients with narcolepsy starting solriamfetol

Abstract Introduction Solriamfetol (Sunosi) is a dopamine/norepinephrine reuptake inhibitor approved (EU/US) to treat excessive daytime sleepiness (EDS) in adults with narcolepsy (75–150 mg/day) or obstructive sleep apnoea (OSA) (37.5–150 mg/day). This study characterised real-world dosing and titration with solriamfetol in patients with narcolepsy. Methods A retrospective patient chart review was conducted among US-based physicians prescribing solriamfetol. Initiation strategies were de novo (no prior EDS medication), transition (switched/switching from existing EDS medications to solriamfetol), or add-on (adding solriamfetol to current EDS medication). Results Twenty-three physicians entered data from 70 patients with narcolepsy (type 1, 24/70; type 2, 46/70; mean+/-SD age, 40+/-11 years; 57% female; 6 also had OSA). EDS was mainly moderate (59%) or severe (36%). Nineteen patients (27%) initiated de novo, 31 (44%) transitioned, and 20 (29%) were add-on. Most patients started solriamfetol at 75 mg (86%) and were stable at 150 mg (76%). Most (67%) had 1 dose adjustment; median (range) time to a stable dose was 14 (1–60) days. EDS severity (44% of patients) was frequently considered when titrating. Fourteen of 22 (64%) transitioning from wake-promoting agents (WPAs) stopped them abruptly; 5/9 (56%) using stimulants tapered off. Discussion In a real-world study, most physicians prescribing solriamfetol to patients with narcolepsy started at 75 mg, tapered stimulants, abruptly discontinued WPAs, and made 1 dose adjustment. Support Jazz Pharmaceuticals

P147 Solriamfetol Titration & AdministRaTion (START): Characteristics of patients with obstructive sleep apnoea (OSA) and prescriber rationale for starting treatment with solriamfetol

Abstract Introduction Solriamfetol (Sunosi) is a dopamine/norepinephrine reuptake inhibitor approved (EU/US) to treat excessive daytime sleepiness (EDS) in adults with OSA (37.5–150 mg/day) or narcolepsy (75–150 mg/day). This study examined characteristics of patients with OSA initiating solriamfetol and prescribers’ rationales. Methods This descriptive study included a retrospective patient chart review among US-based physicians prescribing solriamfetol for patients with OSA/narcolepsy. Solriamfetol initiation strategies were classified as de novo (no prior EDS medication), transition (switched/switching from existing EDS medications), or add-on (adding to current EDS medication). Results Physicians (n=24) entered data from 50 patients with OSA (mean+/-SD age, 52+/-9.1 years; 62% male). EDS was primarily moderate (56%) or severe (36%). Mean+/-SD Apnea-Hypopnoea Index at OSA diagnosis was 33.1+/-19.7 (n=37). The most common nonpharmacologic treatment was positive airway pressure (n=39, 78%); 36/39 (92%) were considered adherent. Common comorbidities included obesity (BMI>/=30) (n=25, 50%), cardiovascular disorders (n=16, 32%), and type 2 diabetes (n=14, 28%). Twenty-two (44%) patients were de novo, 26 (52%) transitioned (primarily from wake-promoting agents [18/26, 69%]), and 2 (4%) added solriamfetol (to stimulants). The efficacy of solriamfetol prompted most discussions to prescribe de novo (18/22, 82%); a desire for improved efficacy and/or augmentation of other medications prompted most transitioning (15/26, 58%) and add-on (2/2, 100%) therapy. At data collection, 48 (96%) patients were stable on solriamfetol; one each discontinued due to lack of efficacy and side effects. Discussion Efficacy was a key consideration for physicians prescribing solriamfetol for EDS in a real-world sample of patients with OSA. Support Jazz Pharmaceuticals

Lengthening the Lower Extremities of Children with Ollier's and Maffucci's Enchondromatosis Using Implantable Lengthening Nails.

There are multiple forms of enchondromatosis with Ollier’s and Maffucci’s being the most prevalent types. Limb length discrepancy is a common problem in patients with Ollier’s and Maffucci’s enchondromatosis. There are multiple reports about lengthening bones in patients with enchondromatosis using external fixators. However, there are no case series regarding the use of implantable lengthening technology. The purpose of this paper is to describe our experience with implantable nail lengthening in patients with enchondromatosis. A retrospective chart and radiographic review of patients with enchondromatosis who underwent implantable nail limb lengthening was performed. Seven patients with 14 bony segments were reviewed. A total of 11/14 lengthenings were completed without difficulty. There were no issues in terms of fixation location in patients with Ollier’s disease. One patient with Maffucci’s syndrome experienced migration of the nail during two lengthenings due to a combination of intralesional fixation and preconsolidation. One patient with Ollier’s disease developed a knee extension contracture requiring manipulation under anesthesia. No other complications were recorded. The use of implantable nail lengthening to resolve limb length discrepancies in patients with Ollier’s disease appears to be safe and effective.

Epidemiology of keratitis/scleritis-related endophthalmitis in a university hospital in Thailand

To demonstrate the demographics, associated factors, clinical presentations, microbiology, management, visual outcome and complications of keratitis/scleritis-related endophthalmitis (KSE). A retrospective chart of all endophthalmitis patients diagnosed between September 2001 and August 2011 was reviewed. Only endophthalmitis cases with previous corneal or scleral infection were included in the study. The patients were followed until losing vision or eyeball, becoming phthisis, or the end of 2018. Eighty-seven patients with KSE were identified, all unilateral. The mean age was 56.4 ± 21.4 years. There was a slight male predilection (55 patients, 63.2%). The mean follow-up time was 50 ± 149 weeks. The causative pathogens were identified in 35 patients (40.2%), with the highest frequency being bacteria. The most common bacterium was Pseudomonas aeruginosa (n = 13), and the most common fungus was Aspergillus sp. (n = 5). Fifteen patients achieved (17.2%) final visual acuity (VA) of hand motion or better after treatment. Eyeball removal was performed in 61 (70.1%) patients. From multivariate analysis, the only prognostic factor for poor final VA (worse than hand motion, HM) was poor VA (worse than HM) at the initial visit (relative risk 1.97, 95% confidence interval 1.15–3.36, p = 0.013). KSE is uncommon but has a devastating outcome. We found that the patient’s initial VA was the only predictor for their final vision. P. aeruginosa was the most common identifiable organism in this study. However, several fungal infections were recognised. These findings should raise awareness for treatment of KSE in the tropics.

Real-world effectiveness of lenvatinib monotherapy among previously treated unresectable hepatocellular carcinoma patients in United States clinical practices.

e16129 Background: In the United States (U.S.), lenvatinib monotherapy was approved in August 2018 for first-line treatment of patients with unresectable hepatocellular carcinoma (uHCC) based on the pivotal trial, REFLECT. Treatment patterns in uHCC are evolving with recent approvals. The main objective of our real-world data (RWD) study was to assess treatment patterns and clinical effectiveness of lenvatinib among previously treated uHCC patients in U.S. clinical practices. Methods: A retrospective patient chart review study was conducted among U.S. adult patients (≥18 years) with uHCC and ECOG status of 0 or 1, who initiated lenvatinib monotherapy as second- or later-line systemic therapy between Aug 2018 and Sept 2019. Data were extracted from individual patients’ electronic health records and captured in electronic case report forms. Clinical outcomes assessed include provider-reported best response, progression-free survival (PFS) and overall survival (OS). PFS and OS were estimated using Kaplan-Meier methods. For PFS, patients were censored at end of treatment or end of follow-up in case of ongoing treatment, while censoring occurred at end of follow-up for OS. Results: Of 164 patients, median age was 62 years, majority were male (72%), and most were Caucasian (56%) followed by African American (23%). The most common liver disease etiologies were alcohol-related (32%), hepatitis C (26%), non-alcoholic steatohepatitis (21%) and hepatitis B (15%). Only one-third (31%) had Child Pugh A cirrhosis, with nearly half (49%) having Child Pugh B cirrhosis. Most patients had Barcelona Clinic Liver Cancer Stage B (24%) or C (38%) disease. Median body weight was 77 kg, and the median starting dose of lenvatinib was 12 mg daily. Median duration of lenvatinib treatment was 6.9 months, with 43% of patients remaining on lenvatinib at end of follow-up. RECIST v1.1 was reported as the criteria used to assess response in 60% of patients. Provider-reported best response was complete response (CR):9%, partial response (PR):45% and stable disease (SD): 26%. Median PFS and median OS were estimated to be 12.5 months and 14.0 months respectively. At 6 and 12 months, landmark PFS was 71% and 52%, respectively and landmark OS was 84% and 58%, respectively. PFS and OS estimates were consistent in subgroup analyses among those who had received lenvatinib in the second-line (81%, n=133) or treated with lenvatinib post immunotherapy (66%, n=109) (Table). Conclusions: Results from this retrospective real-world study affirm the clinical effectiveness of lenvatinib monotherapy among previously treated uHCC patients, including those with prior immunotherapy.[Table: see text]

482 Solriamfetol Titration & AdministRaTion (START): dosing and titration strategies in patients with narcolepsy starting solriamfetol

Abstract Introduction Solriamfetol (Sunosi®), a dopamine/norepinephrine reuptake inhibitor, is approved (US and EU) to treat excessive daytime sleepiness (EDS) in adults with narcolepsy (75–150 mg/day) or obstructive sleep apnea (OSA) (37.5–150 mg/day). Previous research examined the use of solriamfetol in clinical trial settings but research in real-world settings was not previously conducted. This study characterized real-world dosing and titration with solriamfetol. Methods This virtual, descriptive study included a quantitative retrospective patient chart review among US-based physicians prescribing solriamfetol. Target enrollment was 25 physicians treating patients with EDS associated with OSA or narcolepsy. Titration strategies were classified as de novo (no prior EDS medication), transition (switched/switching from existing EDS medications onto solriamfetol), or add-on (adding solriamfetol to current EDS medication). Results Twenty-six physicians participated. Seventy patients with narcolepsy were analyzed (type 1, n=24; type 2, n=46; mean±SD age, 40±11 years; 57% female; 6 also had OSA); EDS was primarily moderate (59%) or severe (36%). Solriamfetol initiation was de novo for 19 (27%) patients, transition for 31 (44%), and add-on for 20 (29%). Most patients (86%) started solriamfetol at 75 mg; 11% and 3% started at 37.5 mg and 150 mg, respectively. The final/stable dose was 150 mg for 76% (53/70) of patients and 75 mg for 24% (17/70). Most patients (67%) had 1 dose adjustment to reach their final dose; 4% had 2 adjustments, 4% had 3 adjustments, and 24% had none. Mean±SD time to reach a stable dose was 15.1±11.8 days overall, 19.4±9.3 days with de novo treatment, 15.0±13.7 days for transition, and 11.9±8.6 days for add-on. Physicians most frequently considered EDS severity (44% of patients) when titrating. Among patients transitioning, 14/22 (64%) taking a wake-promoting agent (WPA) discontinued it abruptly while 5/9 (56%) taking a stimulant were tapered off. Physicians were overall likely (n=33, 47%) or very likely (n=30, 43%) to recommend their approach for similar patients. Conclusion In a real-world study, the majority of physicians prescribing solriamfetol for patients with narcolepsy started at the 75-mg dose, tapered stimulants but abruptly discontinued WPAs, and made 1 adjustment to reach a stable dose across 15 days on average. Support (if any) Jazz Pharmaceuticals

481 Solriamfetol Titration & AdministRaTion (START): Characteristics of patients with narcolepsy and solriamfetol prescriber rationale

Abstract Introduction Pharmacotherapy for excessive daytime sleepiness (EDS) associated with narcolepsy is diverse, with factors such as efficacy, side effects, and tolerance influencing treatment decisions. Solriamfetol (Sunosi®), a dopamine/norepinephrine reuptake inhibitor, is approved (US and EU) to treat EDS in adults with narcolepsy (75–150 mg/day) or obstructive sleep apnea (OSA) (37.5–150 mg/day). This study characterized real-world patients with narcolepsy starting solriamfetol and prescribers’ rationales for initiating treatment. Methods This virtual, descriptive study included a quantitative retrospective patient chart review among US-based physicians prescribing solriamfetol. Target enrollment was 25 physicians treating patients with EDS associated with OSA or narcolepsy. Treatment initiation was classified as de novo (no EDS medication prior to solriamfetol), transition (switched/switching from existing EDS medications onto solriamfetol), or add-on (adding solriamfetol to current EDS medication). Results Twenty-six physicians participated. Seventy patients with narcolepsy were analyzed (type 1, n=24; type 2, n=46; mean±SD age, 40±11 years; 57% female; 6 also had OSA); EDS was primarily moderate (59%) or severe (36%). Twenty-two patients (31%) were obese (BMI≥30); other common physician-reported comorbidities were migraine headaches (n=12, 17%), depression (n=10, 14%), and cardiovascular disorders (n=10, 14%). Solriamfetol initiation was de novo for 19 (27%) patients, transition for 31 (44%), and add-on for 20 (29%). Patients transitioning to solriamfetol were taking 1 (29/31, 94%) or 2 (2/31, 7%) prior EDS medications; patients adding solriamfetol were taking 1 (16/20, 80%), 2 (3/20, 15%) or 3 (1/20, 5%). Most patients transitioning to solriamfetol were taking wake-promoting agents (22/31, 71%); patients adding solriamfetol were most frequently taking sodium oxybate (11/20, 55%). Solriamfetol’s efficacy profile was the primary reason prompting the discussion to prescribe solriamfetol de novo (12/19, 63%); need for better efficacy/augmenting effects of other medications was the primary reason for transitioning (18/31, 58%) and add-on therapy (19/20, 95%). At data collection, 63 (90%) patients were still on a stable solriamfetol dose. The most common reasons for discontinuing solriamfetol were lack of efficacy (n=3) and side effects (n=3). Conclusion Efficacy and the need for improved efficacy over existing medication(s) were key considerations for physicians prescribing solriamfetol treatment to patients with narcolepsy in clinical practice. Support (if any) Jazz Pharmaceuticals

Epidemiology of hip fracture in Botswana

SummaryA retrospective population-based survey in the Republic of Botswana determined the incidence of fractures at the hip over 3 years. The estimated number of such fractures nationwide for 2020 was 103 and is predicted to increase.ObjectiveThis article describes the epidemiology of hip fractures in the Republic of Botswana.MethodsA retrospective patient chart review was conducted to identify from hospital registers the number of patients diagnosed with hip fracture in 2009, 2010, and 2011. Age- and sex-specific incidence of hip fracture was determined from which lifetime probabilities and future projections for hip fracture were calculated.ResultsThe incidence of hip fracture was low and comparable to rates reported from Tunisia. The remaining lifetime risk of hip fracture at the age of 50 years in men and women was 1.4 and 1.1%, respectively. The incidence of hip fracture suggested that the estimated number of hip fractures nationwide in persons over the age of 50 years for 2020 was 103 and is predicted to increase by more than threefold to 372 in 2050.ConclusionThe hip fracture rates can be used for healthcare planning. Additionally, these data can be used to create a FRAX model to help guide decisions about treatment.

Primary Testicular Non-Hodgkin Lymphoma: A Retrospective Single Centre Experience of 26 Cases with Long Follow Up

Introduction: Primary testicular lymphoma is a rare and aggressive malignancy representing 1% to 2% of all non-Hodgkin lymphomas (NHL) and accounts for approximately 5% of all testicular tumors. The aim of this study was to analyse clinical characteristics, therapy and survival outcomes of patients with primary testicular lymphoma diagnosed at our hospital from 1998 to 2017, and to compare differences in survival based on Ann Arbor Stages. Methods: A retrospective patient chart review was done to analyse the patient clinical characteristics, therapy and survival outcomes. Survival was calculated using Kaplan-Meier survival analysis. Results: Twenty-six patients were included; the mean age was 85±6.7 years. All patients presented with testicular tumor. Of the 26 patients, 17 patients were stage I, one stage III, and 8 stage IV. Orchiectomy was performed in all patients. 8 patients received no further treatment. Of the remaining 18 patients, overall, 18 received systemic chemotherapy and 5 radiation therapy. Six patients received intrathecal chemotherapy prophylaxis. Seventeen patients achieved complete remission. Four patients achieved partial remission; one patient had no response. Eleven patients died. Median survival was 144 months and was statistically significantly different between early versus advanced stage (stage I/II: 144 months; stage III-IV: 73 months, p=0.006). Conclusion: Primary testicular lymphomas are a rare and aggressive malignancy of extranodal lymphomas. Survival was different in early stages I/II versus advanced stages III- IV. Randomized, multi-center prospective studies could help to establish better prognostic and multi-modal therapy strategies.

Real-world effectiveness of lenvatinib monotherapy among unresectable hepatocellular carcinoma patients treated in United States clinical practices.

273 Background: In the United States (U.S.), lenvatinib monotherapy was approved in August 2018 for first-line treatment of patients with unresectable hepatocellular carcinoma (uHCC) based on the pivotal trial, REFLECT. Real-world data are essential to assess if this efficacy translates into effectiveness in clinical practice. The main objective of our real-world data (RWD) study was to assess clinical characteristics and effectiveness of lenvatinib among patients treated in U.S. clinical practices. Methods: A retrospective patient chart review study was conducted among adult patients (≥18 years) in the U.S. initiating lenvatinib monotherapy as first-line (1L) systemic therapy for uHCC between Aug 2018 and Sept 2019 and with ECOG status of 0 or 1. Data were extracted from individual patients’ electronic health records and captured in electronic case report forms. Clinical outcomes assessed include provider-reported best response, progression-free survival (PFS) and overall survival (OS). PFS and OS were estimated using Kaplan-Meier methods. For PFS, patients were censored at end of treatment or end of follow-up in case of ongoing treatment, while censoring occurred at end of follow-up for OS. Results: Among 233 patients treated with 1L lenvatinib monotherapy, majority were male (68%) and most were Caucasian (52%) or African American (25%). Median age was 63 years and median body weight was 76 kg. The most common etiologies of liver disease were hepatitis C (36%), alcohol-related liver disease (28%), hepatitis B (16%) and non-alcoholic steatohepatitis (14%). Most patients had compensated cirrhosis, with 49% Child Pugh A and 43% Child Pugh B. All patients had uHCC, with most having Barcelona Clinic Liver Cancer stage B (29%) or C (44%) disease. Portal vein invasion was reported in 19%, of whom7% had main portal vein involvement. The median starting dose of lenvatinib was 12 mg daily. Over a median follow-up period of 9 months from HCC diagnosis, median PFS and OS were not reached. At 6 and 12 months landmark PFS was 85% and 65%, respectively and landmark OS was 92% and 73%, respectively. In the overall cohort, provider-reported best response was complete response (CR): 21%, partial response (PR):44% and stable disease (SD): 26%. Based on RECIST 1.1 (n = 125) CR:16%, PR:54%, SD:26% and mRECIST (n = 11) CR:73%, PR:0% and SD:18% were reported. Average duration of lenvatinib treatment was 7.4 months (median: 6.7 months) with 61% of patients remaining on lenvatinib at end of follow-up. Second-line (2L) treatment was initiated in 32 patients, with immunotherapy (50%), sorafenib (31%) and regorafenib (9%) being most common. Median time to 2L treatment from initiation of lenvatinib was about 8 months. Conclusions: Results from this retrospective real-world study in an U.S. population affirm the clinical effectiveness of 1L lenvatinib monotherapy among patients with uHCC.

Evaluating antibiotic use and developing a tool to optimize prescribing in a family-centered HIV clinic in Eswatini.

In a human immunodeficiency virus (HIV) clinic for children and their families in Eswatini, we sought to understand the use of antibiotics and identify specific areas for improvement. We performed a retrospective patient chart review as part of a quality improvement (QI) initiative to assess antimicrobial use before and after implementation of a standardized antimicrobial guide. For each prescribing period, 100 random patient encounters were selected for review if the indication for antibiotics, duration, and dose were consistent with World Health Organization (WHO) guidelines. Two physicians reviewed each encounter using a structured abstraction tool, with a third resolving discrepancies. Results were analyzed using a chi-square test of proportions and a structured survey was performed to assess perceptions of the guide. After the implementation of an antimicrobial guide, there was a significant decrease in the proportion of clinic visits with an antibiotic prescribed (p < 0.001). Incorrect indication for antimicrobial use decreased from 20.4% in the initial period to 10.31% and 10.2% but did not reach significance (p = .0621) in the subsequent periods after implementation. Incorrect dose/duration decreased from 10.47% in the initial period to 7.37% and 3.1% in the subsequent periods, but this was also was not significant (p = 0.139). All prescribers who completed the survey felt that it positively impacted their prescribing. Our study found that an antimicrobial guide reduced and improved the prescription of antimicrobials, demonstrating practical solutions can have a lasting impact on prescribing in low resource settings.

156. Evaluating Antibiotic Use and Developing a Tool to Optimize Prescribing in a Pediatric HIV Clinic in Eswatini

BackgroundAntibiotic resistance is an emerging global health issue, fueled by inadequate surveillance systems and the absence of antimicrobial stewardship. In resource-limited settings, antimicrobial use is often based on clinical evaluation rather than microbiologic evidence, making treatment guidelines and the education of healthcare providers paramount to ensuring appropriate antimicrobial prescribing. In a human immunodeficiency virus (HIV) clinic for children and their families in Eswatini, we sought to understand the use of antibiotics and identify specific areas for improvement.MethodsWe performed a retrospective patient chart review as part of a quality improvement (QI) initiative to assess antimicrobial use before and after implementation of a standardized antimicrobial guide. For each prescribing period, 100 random patient encounters were selected for review to observe if the indication for antibiotics, duration, and dose were consistent with World Health Organization (WHO) guidelines. Two physicians reviewed each encounter to determine the appropriateness of antibiotic use using a structured abstraction tool, with a third resolving discrepancies. Results were analyzed using a chi-square test of proportions and a structured survey was performed to assess perceptions of the guide.ResultsAfter the implementation of an antimicrobial guide, there was a significant decrease in the proportion of clinic visits with an antibiotic prescribed (p < 0.001). Incorrect indication for antimicrobial use decreased from 20.4% in the initial period, to 10.31% and 10.2% but did not reach significance (p=.0621) in the subsequent periods after implementation. Incorrect dose/duration decreased from 10.47% in the initial period to 7.37% and 3.1% in the subsequent periods, but this was also was not significant (p = 0.139). All prescribers who completed the survey used the antimicrobial guide and felt that it positively impacted their prescribing patterns.ConclusionOur study found that an antibiotic guide reduced and improved the prescription of antimicrobials. Antimicrobial stewardship is a global problem and this data demonstrates that practical solutions can have a lasting impact on antimicrobial prescribing in low resource settings.Disclosures All Authors: No reported disclosures

The prevalence of asymptomatic carriers of COVID-19 as determined by routine preoperative testing.

The coronavirus disease SARS-CoV-2 (COVID-19) has swiftly spread throughout the globe, greatly influencing all aspects of life. As in previous pandemics, concerns for limited resources and a sustainable medical workforce have been on the forefront of infrastructure modifications. Consequently, surgical specialties have needed to consider each surgical case for necessity and safety during the COVID-19 outbreak. At our institution, availability of SARS-CoV-2 assay has allowed preoperative testing of asymptomatic surgical patients. To better define the prevalence of asymptomatic carriers in a surgical population and to better understand the impact of testing on our personal protective equipment (PPE) supply. We began routine, preoperative testing for all asymptomatic patients coming to our academic medical centre on 30 March 2020. Scheduled surgeries were deemed urgent by the surgeon with a review for appropriateness by a novel surgical committee. A retrospective patient chart review was performed. Emergency surgeries were excluded. Asymptomatic patients with positive test results had their surgeries rescheduled at the discretion of the surgeon and patient. Patients who tested negative underwent surgery with staff using standard PPE. Eighty-four asymptomatic surgical patients were tested preoperatively with three (3.6%) testing positive for SARS-CoV-2. Preoperative testing saved 498 N95 respirators over this time period. This is the first report of routine COVID-19 preoperative testing in an asymptomatic surgical population. Within this population, there is a 3.6% rate of asymptomatic SARS-CoV-2 carriers. Through this practice, personnel exposure can be minimised and access to PPE can be preserved.

Inclusion of L5–S1 in oblique lumbar interbody fusion–techniques and early complications–a single center experience

Background contextThe oblique prepsoas retroperitoneal approach to the lumbar spine for interbody fusion or oblique lumbar interbody fusion (OLIF) provides safe access to nearly all lumbar levels. A wide interval between the psoas and aorta allows for a safe and straightforward left-sided oblique approach to the discs above L5. Inclusion of L5–S1 in this approach, however, requires modifications in the technique to navigate the complex and variable vascular anatomy distal to the bifurcation of the great vessels. While different oblique approaches to L5–S1 have been described in the literature, to our knowledge, no previous study has provided guidance for the choice of technique. PurposeOur objectives were to evaluate our early experience with the safety of including L5–S1 in OLIF using 3 different approach techniques, as well as to compare early complications between OLIF with and without L5–S1 inclusion. Study designRetrospective cohort study. Patient sampleOf the 87 patients who underwent lumbar interbody fusion at 167 spinal levels via an OLIF approach, 19 included L5–S1 (group A) and 68 did not (group B). Outcome measuresDemographics, levels fused, indications, operative time (ORT), estimated blood loss (EBL), vascular ligation, intraoperative blood transfusion, length of stay (LOS), discharge to rehabilitation facility, and complications (intraoperative, early ≤90 days, and delayed >90 days) were retrospectively assessed and compared between the groups. MethodsA retrospective chart and imaging review of all consecutive patients who underwent OLIF at a single institution was performed. Indications for OLIF included symptomatic lumbar degenerative stenosis, deformity, and spondylolisthesis. The L5–S1 level, when included, was approached via one of the following 3 techniques: (1) a left-sided intrabifurcation approach; (2) left-sided prepsoas approach; and (3) right-sided prepsoas approach. Vascular anatomic variations at the lumbosacral junction were evaluated using the preoperative magnetic resonance imaging (MRI), and a “facet line” was proposed to assess this relationship. A minimum of 6 months of follow-up data were assessed for approach-related morbidities. ResultsDemographics and operative indications were similar between the groups. The mean follow-up was 10.8 (6–36) months. ORT was significantly longer in group A than in group B (322 vs. 256.3 min, respectively; p=.001); however, no difference in ORT between the two groups was found in the subanalyses for 2- and 3-level surgeries. Differences in EBL (260 vs. 207.91 cc, p=.251) and LOS (2.76 vs. 2.48 days, p=.491) did not reach statistical significance. Ligation of the iliolumbar vein, segmental veins, median sacral vessels, or any vascular structure, as needed for adequate exposure, was required in 13 (68.4%) patients from group A and 4 (5.9%) from group B (p<.00001). Two patients suffered minor vascular injuries (1 in each group); however, no major vascular injuries were seen. Complications were not significantly different between groups A and B, or between the three approaches to L5–S1, and trended lower in the latter part of the series as the learning curve progressed. ConclusionsInclusion of L5–S1 in OLIF is safe and feasible through three different approaches but likely involves greater operative complexity. In our early experience, inclusion of L5–S1 showed no increase in early complications. This is the first series that reports the use of 3 different oblique approaches to L5–S1. The proposed “facet line” in the preoperative MRI may guide the choice of approach.