Ancillary Care Research Articles

PCN62 Real-World Costs of FRONT-LINE Treatment for Peripheral T-Cell Lymphoma in France, Germany, and the United Kingdom

To estimate the cost of first-line treatment in patients with PTCL, from the government payer perspective, in France, Germany, and the UK A cost calculator was designed to apply country-specific unit costs to treatments and other healthcare resource use collected in a retrospective medical chart review study conducted in France, Germany, and the UK. The study included PTCL patients diagnosed between January 1, 2014 and December 31, 2016, who received at least front-line treatment for PTCL. Medical chart data, including PTCL treatments, adjunctive therapies (e.g., antibiotics, antivirals, granulocyte-colony stimulating factor), radiotherapy, laboratory tests, inpatient and outpatient visits, and ancillary care, were collected. Unit costs for each type of resource used were sourced from tariffs in each country, and adjusted to 2020 values. Resource use was then multiplied by the corresponding unit cost to calculate the total cost by resource type, and the mean cost per patient was calculated. Results were stratified by country, PTCL subtype, front-line treatment regimen, age, and receipt of stem cell transplant. Data for a total of 165 patients (France, 53; Germany, 56; UK, 56) were collected in the chart review. The median age at diagnosis was 62 years, 81% of patients had an ECOG status of 0-1 at diagnosis, and 72% had stage III/IV disease. Total costs of first-line therapy were €12,257 per patient in France, €22,392 in Germany, and €32,461 in the UK. The greatest proportion of costs was attributed to adjunctive therapies in France (€4,509) and Germany (€11,539), and stem cell transplant in the UK (€13,419). Of note, patients in the UK were more likely to have received a stem cell transplant (44.6%) compared to France (13.2%) and Germany (19.6%). Adjunctive therapies and stem cell transplants are major cost drivers in patients with PTCL receiving front-line treatment.

Aging and the prudential lifespan account.

As individuals grow older, they usually require assistance with the daily tasks of self-care. This type of assistance, ancillary care, is essential to maintaining the health of those who need these services. In his prudential lifespan account, Norman Daniels includes access to such services making his account an attractive proposal given the current demographic shift. In this paper, I examine the prudential lifespan account through the lens of old age and I focus on the two concepts on which the lifespan account relies. I show that these two concepts, normal species functioning and opportunity cannot buttress Daniels's lifespan account; at least it cannot do so for older persons. The tensions that I identify in the prudential lifespan account in relation to aging are instructive for the more recent proposals to include aging in a theory of health and health justice. In addition, my analysis allows me to demonstrate that Daniels's view of opportunity is irreconcilable to capabilities, the latter being more adaptable to the realities of aging. If capabilities appear more promising, it is nonetheless imperative that the specificities of extended care, such as the need for unpaid caregiving, be taken into consideration.

P0293 / #1640: BUBBLE CPAP AND HIGH FLOW NASAL CANNULA IN LOW- RESOURCE SETTINGS: PROMISING THERAPIES OR HAVE WE BURST THE BUBBLE?

Aims & Objectives: Pneumonia is a leading cause of mortality among children in low-resource settings (LRS). World Health Organization treatment recommendations include low-flow oxygen for children with severe pneumonia. Bubble continuous positive airway pressure (bCPAP) is a non-invasive respiratory support modality that may benefit children in LRS with severe pneumonia. We examine results from three randomized controlled trials comparing bCPAP with standard oxygen therapy among children with severe pneumonia in LRS. Methods: The data from the three trials1,2,3 vary greatly and were not amenable to a meta-analysis. However, a side-by-side comparison (Figure 1) will be used to foster discussion among session participants. Ongoing work will also be discussed. Results: Trials differed by location, access to critical care, and inclusion and exclusion criteria (Figure 1). Trials differed by bCPAP systems and pressures used, escalation and weaning protocols, frequency of monitoring, physician availability, nursing ratios and feeding protocols. Chisti et al., determined that bCPAP reduced treatment failure and mortality; Wilson et al., reported a survival benefit for patients under 12 months of age; the trial described by McCollum et al., was stopped early for futility and safety concerns. FIGURE 1Conclusions: bCPAP may offer benefit to children in LRS with severe pneumonia. Careful assessment must be made for children who will receive bCPAP. Areas of debate include: 1. Inclusion criteria; 2. Physician supervision and nurse ratios; 3. Escalation and weaning protocols; 4. Critical care access; 5. Ancillary care, including feeding. WFPICCS is an ideal platform in which to address the best practices for bCPAP in LRS.

HIV prevention research and COVID-19: putting ethics guidance to the test

BackgroundCritical public health measures implemented to mitigate the spread of the novel coronavirus disease (COVID-19) pandemic have disrupted health research worldwide, including HIV prevention research. While general guidance has been issued for the responsible conduct of research in these challenging circumstances, the contours of the dueling COVID-19 and HIV/AIDS pandemics raise some critical ethical issues for HIV prevention research. In this paper, we use the recently updated HIV Prevention Trials Network (HPTN) Ethics Guidance Document (EGD) to situate and analyze key ethical challenges related to the conduct of HIV prevention research during the COVID-19 pandemic as well as identify potential areas for refinement of the guidance document based on this unprecedented state of affairs.Main bodyNecessary actions taken for HIV prevention research studies due to the COVID-19 pandemic involve an array of ethical issues including those related to: (1) risk mitigation; (2) behavior change; (3) compounding vulnerability; (4) community engagement; (5) trial reopening; and 6) shifting research priorities.ConclusionsIn the context of the dueling HIV and COVID-19 global pandemics, research teams and sponsors must be nimble in responding to the rapidly changing environment by being sensitive to the associated ethical issues. The HTPN EGD provides a rich set of tools to help identify, analyze and address many of these issues. At the same time, future refinements of the HPTN EGD and other research ethics guidance could be strengthened by providing explicit advice regarding the ethical issues associated with disrupted research and the reopening of studies. In addition, additional consideration should be given to appropriately balancing domains of risk (e.g., physical versus social), addressing the vulnerability of research staff and community partners, and responding to un-anticipatable ancillary care needs of participants and communities. Appropriately addressing these issues will necessitate conceptual work, which would benefit from the careful documentation of the actual ethical issues encountered in research, the strategies implemented to overcome them, and their success in doing so. Throughout all of these efforts, it is critical to remember that the HIV pandemic not be forgotten in the rush to deal with the COVID-19 pandemic.

Practices and Attitudes toward Returning Genomic Research Results to Low-Resource Research Participants

Introduction: Many research programs are challenged to accommodate low-resource research participants’ (LRRP) ancillary care needs when returning genomic research results. We define LRRP as those who are low income, uninsured, underinsured, or facing barriers to act upon the results returned. This study evaluates current policies and practices surrounding return of results (RoR) to LRRP, as well as the attitudes of investigators toward providing ancillary care to LRRP. Methods: A semi-structured interview study was conducted with representatives of 35 genomic research programs nationwide. Eligible programs were returning, or planning to return, medically actionable genomic results to participants. Results: Three content categories emerged from this study, including: (1) RoR structures, (2) barriers to RoR to LRRP, and (3) solutions to meet community and LRRP needs. Three major structures of RoR emerged: (1) RoR Embedded in Clinical Care, (2) RoR Independent of Clinical Care, and (3) Reliance on Clinical Partnerships to Facilitate RoR. Inadequacy of program resources to address the needs of LRRP was commonly considered a significant obstacle. The attitudes and views of informants regarding responsibility to provide ancillary care for LRRP receiving genomic results were highly varied. Some informants believed that genomic sequencing and testing was not a priority for LRRP because of other pressing issues in their lives, such as housing and food insecurity. Research programs differ regarding whether clinical and social support for LRRP is considered within the purview of the research team. Some programs instituted accommodations for LRRP, including social work referral and insurance enrollment assistance. Conclusion: Support to access downstream treatment is not readily available for LRRP in many genomic research programs. Development of best practices and policies for managing RoR to LRRP is needed.

Towards an appropriate ethics framework for Health and Demographic Surveillance Systems (HDSS): learning from issues faced in diverse HDSS in sub-Saharan Africa

IntroductionHealth and Demographic Surveillance Systems (HDSS) collect data on births, deaths and migration from relatively small, geographically defined populations primarily in Africa and Asia. HDSS occupy a grey area between...

The Impact of COVID-19 on Service Provision for Emergency Department Patients Post-Opioid Overdose: A Field Report.

Background:To minimize the spread of COVID-19, health and ancillary care providers altered service delivery patterns. These changes included an increase in reliance on telemedicine modalities, a reduction in services or hours of operation, and prohibiting guests and nonessential personnel from healthcare settings. We describe a rapid environmental assessment with senior emergency department (ED) practitioners in Rhode Island to understand how COVID-related procedural changes impact the provision of post-overdose care in ED.Methods:Semi-structured interviews were conducted with 14 senior healthcare practitioners in EDs across Rhode Island from June to July 2020. Interviews were part of a larger, ongoing study examining the implementation and effectiveness of post-opioid overdose care in EDs and sought to understand how COVID-19 had impacted the provision of services for people who use drugs (PWUD).Results:COVID-related policy changes challenged the provision of services to PWUD in the ED, and extended challenges in connecting people with OUD to services in the community. Specifically, challenges included transitions to telehealth modalities, required COVID tests for treatment services, and gaps in community resources.Conclusions:This study underscores opportunities to improve the delivery of services amid overlapping public health crises for PWUD, including bolstering the use of telemedicine in EDs and across the care continuum.

Managing ancillary care in resource-constrained settings: Dilemmas faced by frontline HIV prevention researchers in a rural area in South Africa.

BackgroundWe describe the findings from a research ethics case study, linked with a team evaluating a package of intervention services to prevent HIV infection in adolescent girls and young women (AGYW) living in a rural and poor setting of KwaZulu-Natal, South Africa.MethodsWe conducted qualitative interviews (n=77) with members of the linked research team evaluating the intervention programme, programme implementing staff, AGYW enrolled in the intervention programme, caregivers, ethics committee members, Public Engagement officers, community advisory board members and community stakeholders. Data were analysed iteratively using thematic framework analysis. Themes were determined by the study aims combined with an inductive development of codes emerging from the data.ResultsThe findings show that the burden of providing ancillary care fell primarily on the shoulders of frontline researchers and programme staff. Dilemmas around responding to gender-based violence illustrated the limits of ‘referral to services’ as a solution for meeting ancillary care obligations in contexts with barriers to basic health and social services.ConclusionOur findings show important gaps in meeting ancillary care needs. Participants’ needs required social and economic support which frontline researchers and implementing partners were not able to meet, causing moral distress.

Modification of diet, exercise and lifestyle (MODEL) study: a randomised controlled trial protocol

IntroductionMost cardiovascular disease (CVD)-related events could be prevented or substantially delayed with improved diet and lifestyle. Providing information on structural vascular disease may improve CVD risk factor management, but its...

Comparative analysis of direct and indirect costs of two minimally invasive techniques for the treatment of renal/ureteral calculi smaller than 2 cm

ObjectiveTo perform a comparative analysis of indirect and direct costs of two minimally invasive techniques (extracorporeal shock wave lithotripsy (ESWL) vs. ureteroscopy with holmium laser (URS/RIRS)) for the treatment of renal/ureteral calculi smaller than 2 cm. Material and methodsProspective, comparative, non-randomized study of 84 patients treated for kidney stones smaller than 2 cm between January and December 2016. Of these, 38 (45.67%) were treated with ESWL (18 renal lithiasis and 20 ureteral lithiasis) and 46 (54.32%) with URS/RIRS (22 renal lithiasis and 24 ureteral lithiasis). A total of 19 (41.3%) patients in the URS/RIRS group and 15 (39.5%) patients in the ESWL group were actively working before treatment. The variables analyzed were sex, age, number and size of lithiasis, time (days) off from work due to treatment, estimate of indirect cost due to labor productivity loss and direct treatment costs including follow-up (total number of procedures, ancillary care, visits and diagnostic tests). The 2015 Wage Structure Survey (INE) was used to estimate the indirect cost. In addition, the “Work Productivity and Activity Impairment” (WPAI) questionnaire was also used to determine the level of perceived productivity loss. ResultsThe mean number of sessions until lithiasis resolution was achieved was 2.57 for the ESWL group and 1.04 for the URS. The mean number of days off from work in the URS group was 7.16 days and 3.18 (p = 0.034) in the ESWL group. The total indirect costs resulting from productivity loss were EUR 621.55 and EUR 276.05 for the URS and ESWL, respectively. Direct costs in the ESWL group were EUR 1382.9 and EUR 2317.71 in the URS group. The level of work impairment perceived by patients undergoing URS was 18.88% and 21.33% in the ESWL group. The degree of impairment for performing activities of daily living was 24.44% in the URS and 15% in ESWL. ConclusionsThe ESWL technique requires a higher number of sessions for the resolution of kidney stones under 2 cm, but it has a lower impact on total costs and on the perceived degree of affectation.

Ethics of returning children's individual research findings: from principles to practice.

Little ethical recommendations on returning children's individual research findings are available for researchers in behavioral sciences, especially when compared to genetic research. Anecdotic evidence suggests that since parents are often interested in their child's individual research findings, researchers tend to offer this information as a form of compensation for research participation. Despite good intentions, these practices are not without potential harmful consequences for children. We were confronted with these difficulties and with the paucity of available guidance on this topic, being involved in a longitudinal, infant development study, i.e. tracking infants at risk for autism (TIARA). First, we review current ethical recommendations and discuss their limitations in the light of the TIARA study. Second, we will suggest to revise these recommendations, by identifying and applying the relevant bioethical principles and concepts at hand. Third, as an example of practical implementation, the adopted 'return of research findings'-policy for the TIARA-study is presented. The principles and concepts we engage with are the ancillary care responsibilities of the researcher, non-maleficence and beneficence, the right to an open future of the child, and the avoidance of therapeutic misconception. Ultimately, we present the concrete return of research findings policy implemented in the TIARA-study. Here, we suggest restricting the systematic return of children's individual research findings to cases where findings are considered clinically significant and actionable for the child. We discuss the broader implications for designing and conducting research in behavioral sciences with children.

Análisis comparativo de costes directos e indirectos de dos técnicas mínimamente invasivas, para el tratamiento de la litiasis renoureteral menor de 2 cm

ObjectiveTo perform a comparative analysis of indirect and direct costs of two minimally invasive techniques (extracorporeal shock wave lithotripsy (ESWL) vs. ureteroscopy with holmium laser (URS/RIRS)) for the treatment of renal/ureteral calculi smaller than 2 cm. Material and methodsProspective, comparative, non-randomized study of 84 patients treated for kidney stones smaller than 2 cm between January and December 2016. Of these, 38 (45.67%) were treated with ESWL (18 renal lithiasis and 20 ureteral lithiasis) and 46 (54.32%) with URS/RIRS (22 renal lithiasis and 24 ureteral lithiasis). A total of 19 (41.3%) patients in the URS/RIRS group and 15 (39.5%) patients in the ESWL group were actively working before treatment. The variables analyzed were sex, age, number and size of lithiasis, time (days) off from work due to treatment, estimate of indirect cost due to labor productivity loss and direct treatment costs including follow-up (total number of procedures, ancillary care, visits and diagnostic tests). The 2015 Wage Structure Survey (INE) was used to estimate the indirect cost. In addition, the «Work Productivity and Activity Impairment» (WPAI) questionnaire was also used to determine the level of perceived productivity loss. ResultsThe mean number of sessions until lithiasis resolution was achieved was 2.57 for the ESWL group and 1.04 for the URS. The mean number of days off from work in the URS group was 7.16 days and 3.18 (p = 0.034) in the ESWL group. The total indirect costs resulting from productivity loss were EUR 621.55 and EUR 276.05 for the URS and ESWL, respectively. Direct costs in the ESWL group were EUR 1,382.9 and EUR 2,317.71 in the URS group. The level of work impairment perceived by patients undergoing URS was 18.88% and 21.33% in the ESWL group. The degree of impairment for performing activities of daily living was 24.44% in the URS and 15% in ESWL. ConclusionsThe ESWL technique requires a higher number of sessions for the resolution of kidney stones under 2 cm, but it has a lower impact on total costs and on the perceived degree of affectation.

Views among Malawian women about joining HIV prevention clinical trials when pregnant

BackgroundThe pressing need to expand the biomedical HIV prevention evidence base during pregnancy is now increasingly recognized. Women’s views regarding participation in such trials and initiating PrEP while pregnant are critical to inform evolving policy and best practices aimed at responsibly expanding evidence-based access for this population.MethodsWe conducted 35 semi-structured interviews with reproductive-aged women in Malawi in the local language, Chichewa. Participants were HIV-negative and purposively sampled to capture a range of experience with research during pregnancy. Women’s perspectives on enrolling in three hypothetical HIV prevention trial vignettes while pregnant were explored, testing: (1) oral PrEP (Truvada) (2) a vaginal ring (dapivirine), and (3) a randomized trial comparing the two. The vignettes were read aloud to participants and a simple visual was provided. Interviews were audio-recorded, transcribed, translated, and coded using NVivo 11. Thematic analysis informed the analytic approach.ResultsA majority of women accepted participation in all trials. Women’s views on research participation varied largely based on their assessment of whether participation or nonparticipation would best protect their own health and that of their offspring. Women interested in participating described power dynamics with their partner as fueling their HIV exposure concerns and highlighted health benefits of participation—principally, HIV protection and access to testing/treatment and ancillary care, and perceived potential risks of the vignettes as low. Women who were uninterested in participating highlighted potential maternal and fetal health risks of the trial, challenges of justifying prevention use to their partner, and raised some modality-specific concerns. Women also described ways their social networks, sense of altruism and adherence requirements would influence participation decisions.ConclusionsThe majority of participants conveyed strong interest in participating in biomedical HIV prevention research during pregnancy, largely motivated by a desire to protect themselves and their offspring. Our results are consistent with other studies that found high acceptance of HIV prevention products during pregnancy, and support the current direction of HIV research policies and practices that are increasingly aimed at protecting the health of pregnant women and their offspring through responsible research, rather than defaulting to their exclusion.

Three-Year Results of a Prospective Statewide Insurance Coverage Pilot for Proton Therapy: Stakeholder Collaboration Improves Patient Access to Care.

Proton therapy is increasingly prescribed, given its potential to improve outcomes; however, prior authorization remains a barrier to access and is associated with frequent denials and treatment delays. We sought to determine whether appropriate access to proton therapy could ensure timely care without overuse or increased costs. Our large academic cancer center collaborated with a statewide self-funded employer (n = 186,000 enrollees) on an insurance coverage pilot, incorporating a value-based analysis and ensuring preauthorization for appropriate indications. Coverage was ensured for prospective trials and five evidence-supported anatomic sites. Enrollment initiated in 2016 and continued for 3 years. Primary end points were use, authorization time, and cost of care, with case-matched comparison of total charges at 1 month pretreatment through 6 months posttreatment. Thirty-two patients were approved over 3 years, with only 22 actually receiving proton therapy, versus a predicted use by 120 patients (P < .01). Median follow-up was 20.1 months, and average authorization time decreased from 17 days to < 1 day (P < .01), significantly enhancing patient access. During this time, 25 patients who met pilot eligibility were instead treated with photons; and 17 patients with > 6 months of follow-up were case matched by treatment site to 17 patients receiving proton therapy, with no significant differences in sex, age, performance status, stage, histology, indication, prescribed fractions, or chemotherapy. Total medical costs (including radiation therapy [RT] and non-RT charges) for patients treated with PBT were lower than expected (a cost increase initially was expected), with no significant difference in total average charges (P = .82), in the context of overall ancillary care use. This coverage pilot demonstrated that appropriate access to proton therapy does not necessitate overuse or significantly increase comprehensive medical costs. Objective evidence-based coverage polices ensure appropriate patient selection. Stakeholder collaboration can streamline patient access while reducing administrative burden.

Reducing Readmissions for Heart Failure.

Reducing Readmissions for Heart Failure.

Costs and Cost Drivers Associated with Non-Small-Cell Lung Cancer Patients Who Received Two or More Lines of Therapy in Europe.

PurposeAdvanced non-small-cell lung cancer (aNSCLC; stage IIIB/IV) presents a substantial clinical burden to society; reliable estimates of its economic burden are lacking. Therefore, this study aimed to quantify real-world health care resource utilization (HCRU) and costs of patients with squamous (SQ) and non-SQ (NSQ) aNSCLC who received two or more lines of treatment (2L+) in Europe, and to describe cost-predictors.MethodsThe LENS (Leading the Evaluation of Non-squamous and Squamous NSCLC) retrospective chart review study collected data from 2L+ patients with aNSCLC diagnosed between 07/2009 and 08/2011 (wave 1) or 07/2010 and 09/2012 (wave 2) in France, Germany, Italy, Spain, England, the Netherlands, and Sweden. Patients were followed from diagnosis through most recent visit/death. A weighted average of country-specific unit costs (2018 Euro) was applied to systemic anti-cancer therapy usage and HCRU (hospital/emergency department visit, surgery, radiotherapy, ancillary care, biomarker testing) to determine the total cost from aNSCLC diagnosis to death. Generalized linear models (gamma distribution, log link) were used to assess clinical and demographic predictors.ResultsOf 973 2L+ aNSCLC patients, median overall survival (OS) was 1.5 years from advanced diagnosis (range: 0.2–5.3; median OS: 1.4 [SQ], 1.6 [NSQ]), 79.0% died during follow-up. Weighted mean total per-patient costs were €21,273, ranging from €17,761 (England) to €30,854 (Sweden), and €15,446 (SQ) to €26,477 (NSQ). Systemic drug costs comprised 77.4% of total costs. Insurance status, presence of epidermal growth factor receptor (EGFR) mutation, SQ histology, age, alcohol abuse, and year of diagnosis were significant predictors for lower total costs per patient-month, Eastern Cooperative Oncology Group performance status (ECOG PS) ≥1 and country for higher costs.ConclusionIn the era pre-immunotherapy, HCRU and costs were substantial in aNSCLC 2L+ patients, with most of the costs accrued prior to start of 2L. NSQ patients incurred significantly higher total costs than SQ patients in all participating countries.

Minimizing Risks Is Not Enough: The Relevance of Benefits to Protecting Research Participants.

Forty years ago, the Belmont Report counseled that a "systematic, nonarbitrary analysis of risks and benefits" is vital to ensuring the ethical appropriateness of research with human subjects. Since then, research ethics has devoted considerable attention to the first half of this advice, emphasizing the ethical importance of assessing and minimizing the risks of research with human subjects. Significantly less attention has been devoted to a systematic assessment of the potential benefits of research participation. To the extent that benefits for individual participants are considered at all, commentators tend to focus on their potential to undermine the goal of minimizing risks. A chance for clinical benefit may obscure the fact that research poses risks not present in clinical care, while an offer of financial compensation or ancillary care may induce individuals to accept risks that conflict with their long-term interests. This article argues that, while undoubtedly important, minimizing risks fails to offer sufficient protection for research participants, especially those who cannot consent, because it neither ensures that the risks of research are justified nor protects participants from exploitation. Belmont's advice to develop systematic and nonarbitrary ways to ensure that research participants receive appropriate benefits needs to be heeded as well.

Preeclampsia Risk and Prevention among Pregnant Medicaid Beneficiaries.

Pregnancy-related hypertensive disorders can cause morbidity and mortality. Low-dose aspirin (LDA) reduces risk. This paper aims to assess Medicaid beneficiaries' risk factors for preeclampsia and their providers' clinical use of LDA in the federal Strong Start for Mothers and Newborns II initiative. Twenty-seven awardees with more than 200 care sites served almost 46,000 women. This mixed-methods analysis assesses rates of risks, incidence of pregnancy-related hypertensive disorders, and assessment of care teams' LDA knowledge and reported prescription practices. Many Strong Start participants had risk factors that merited LDA, but most practices reported inconsistent or non-existent prescribing. Use varied within the three care models and among all provider types. Ancillary care team members often had no knowledge of LDA's benefits, resulting in lost opportunities for educating patients and assessing adherence to LDA use. Clear policies and well-integrated care teams could increase evidence-based use, improve pregnancy outcomes, and promote women's lifelong cardiovascular health.

National Database Reported Outcomes Following Craniosynostosis Reconstruction.

While there has been ample interest and literature published regarding craniosynostosis surgical technique, there are few reports on adverse hospital and health system outcomes. The purpose of this study was to describe rate of and risk factors for complications, and adverse outcomes following craniosynostosis reconstruction. This study retrospectively reviewed the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) Pediatric database and identified all patients undergoing craniosynostosis repair from 2012 to 2016. Univariate logistic regression analysis was used to identify significant associations between preoperative risk factors and adverse outcomes. Multivariate logistic regression analysis was then used to identify independent risk factors and causes of prolonged operative times, transfusions, reoperation, prolonged length of hospital stays, and readmission. There were 3924 patients included who underwent craniosynostosis repair, of whom 1732 underwent frontoorbital advancement and 2192 underwent cranial vault remodeling. Transfusion was the most common NSQIP reportable outcome, occurring for 66.5% of all patients. The incidence of reoperation was 2.4% and readmission was 3.0%. This study provides a large descriptive analysis of craniosynostosis repair throughout the United States. Largely nonmodifiable patient risk factors lead to worse health system metrics, with young age, gastrointestinal comorbidities, American Society of Anesthesiologist scores of 3 and greater, reoperation, and a prolonged length of stay as independent risk factors for readmission. This analysis can be used to identify the standard of practice in synostosis care and enhance the implementation of ancillary care services to provide safe and cost-effective care for patients undergoing craniosynostosis repair.

PMS8 RATE OF FRACTURES LEADING TO HOSPITALISATION AND HEALTHCARE BURDEN IN UNTREATED OSTEOPOROSIS ELDERLY PATIENTS IN GERMANY: AN INGEF HEALTHCARE INSURANCE DATABASE ANALYSIS

Osteoporosis (OP) is a skeletal disease that manifests as bone mineral density loss and low-trauma fractures. This database analysis describes the characteristics of untreated OP patients, their rate of fractures, health resource utilization and cost burden. From the InGef database (2011-2016), eligible patients (>=70 years) untreated for OP were identified via a recorded diagnosis of OP (ICD-10 codes M80/M81) or an initial fragility fracture (index point). All patients were followed up for fractures post index. Direct costs included inpatient, outpatient, pharmacy and ancillary care costs. 144,752 patients (mean age 78 years; 73% female, median follow-up of 3.2 years) met the eligibility criteria; 23% had a history of fractures. 48% of patients had cardiac diseases, 32% diabetes and 27% cerebrovascular disease. 30% (43,514) of patients had at least one post-index fracture; common post-index site-specific fractures were: femoral (10%), vertebral (12%), forearm (12%). Two or more post-index fractures were experienced in 7% (10,262) of patients. Median time from index date to 1st fracture was 145.5 days and 1st to 2nd fracture was 270.5 days. 15% (21,879), and 1% (1,658) of patients were hospitalized for fracture-specific and non-fracture OP care. Median number of all-cause admissions and outpatient visits were 2 and 13 per patient, respectively. Median length of hospital stay per patient for fractures and non-OP related stays were 12 and 17 days, respectively. During follow-up, 24% (34,762) of patients died, 11% (5,446) patients initiated OP treatment and 1% (1,929) were lost to follow-up due to other reasons. OP care and fragility fractures directly contributed to a cost burden of €300 million. In this representative cohort (5%) of German patients untreated for OP, the total cost burden of OP care and fragility fractures was €300 million. Such costs may be reduced through systematic OP diagnosis and appropriate treatment strategies.