Health Services Research Studies Research Articles

What is health services research?

In health services research, the health care of the population is examined under everyday conditions. Scientific questions include medical, patient-oriented, system-, performance- and quality-related as well as health economics topics. In health services research, complex interventions, e.g., treatment concepts with multiple therapy components, and/or across multiple sectors, are often implemented. The design of studies in health services research is based on the research question, the setting, and the available data, which can come from avariety of sources.

The psychological effects of research participation on people with dementia: findings from a German exploratory interview study.

The German National Dementia Strategy aims to engage people with dementia in research projects. However, the effects of such research participation on experience and behavior have been insufficiently explored. This study aimed to investigate the psychological effect of research participation on people living with dementia. In a qualitative, exploratory approach, guideline-based interviews were conducted with four persons with dementia who had served as co-researchers on an advisory board in a health services research study for 8 months at that time. The analysis revealed predominantly positive effects of research participation at all levels of experience and behavior. Most effects were reported by the co-researchers on a cognitive level. Both the perception of being competent and of making a positive contribution to oneself and/or others are key effects of research participation. The main effects on an emotional level were joy and wellbeing and on a behavioral level were positive social contacts and social communication. Sadness and insecurity represent the sole negative effects. Nuanced focal points of effects among the individual interviews were found. The results align with existing research highlighting the positive effects of participation on people with dementia. Through advancing an interdisciplinary perspective on their research involvement, we advocate for heightened attention to this topic within the realm of psychology.

Clinical Characteristics and Hearing Aid Uptake Rate of Patients Seen at the Community Hearing Clinic: A Model of Upstream Preventive Care and Earlier Intervention

Background and Aim: Presbyacusis is one of the most common causes of hearing loss for seniors age above 60 years. Yet diagnostic hearing tests are not readily accessible to seniors in the community. Since 2018, the Ministry of Health in Singapore started a pilot program to screen them for their visual, oral, and hearing health in the community and improve accessibility to hearing healthcare. We describe the clinical characteristics of seniors presenting to Community Hearing Clinic (CHC) and compared hearing aid uptake rates with patients seen at a tertiary hospital. Methods: Retrospective cross-sectional descriptive study on Singaporeans with hearing difficulties presenting to the community clinics. Results: Attendance rates were generally positive at more than 80% and is comparable to the specialist outpatient clinic at the tertiary hospital. Hearing aid uptake rates were comparable between CHC and tertiary hospital at 61.9% and 66.9% respectively. Despite having better accessibility with direct access to the audiologists, and more financial subsidies, the eventual uptake rates of hearing aids are not clinically different at the CHC. Conclusion: CHC may be a viable model of improving accessibility to hearing healthcare with audiologists providing the 1st level of triaging safely. However, the cost-effectiveness of this model remains to be seen. Further health service research studies are warranted to determine the cost-effectiveness of sandbox CHC. Right-siting and expanding the sandbox to include access to hearing aid subsidies in private clinics may further help with this move beyond hospital to the community in line with our public health vision. Keywords: Community health services; audiology; hearing aids; financing; governmental

Improving myocardial infarction emergency care: a joint intervention study of the Berlin Brandenburg Myocardial Infarction Registry (B2HIR) and emergency medical services (QS-Notfall)

Abstract Background Rapid myocardial reperfusion is needed to improve clinical outcome after a ST-elevation myocardial infarction (STEMI). Missed early explicit STEMI diagnoses were shown to unfavourably delay STEMI care. A networked approach between emergency medical systems (EMS) and cardiology hospital departments is useful to establish early valid pre-hospital STEMI diagnoses. Purpose The publicly funded "QS-Notfall" joint health services research study intended to improve STEMI care in Berlin (BE) and Brandenburg (BB) by implementing pre-hospital tele-ECG transmission and online ECG training for EMS personnel. Methods As part of B2HIR, 21 cardiology hospital departments (19 in BE, 2 in BB) together with EMS (BE firefighters and regional BB EMS), supported by the Berlin Medical Chamber, established 2 joint interventions to accelerate STEMI care. All EMS and hospitals implemented GDPR compliant telemedical transmission and structured handling of pre-hospital ECGs from patients with chest pain. In addition, we developed an ECG e-learning for emergency physicians and EMS personnel ("STEMI einfach erkennen") and communication between EMS and hospitals was enforced. Patients with acute myocardial infarction (AMI) and symptom onset ≤24h were enrolled. Symptom onset, first medical contact, time of hospital admission ("door"), time of guidewire passage into the coronary artery (reperfusion), and respective care delays were assessed. First obtained ECGs were blindly validated by 3 expert cardiologists. We compared a reference period to a 12-month intervention period with regard to care delays. In addition, STEMI care was analyzed according to the actual use of telemedical ECG transmission and according to the validity of ECG diagnoses. Results N=7303 cases were enrolled (reference period 3657, intervention period 3646, age 66.9y, 27.1% female, STEMI 49.4%). The usage of ECG transmission varied notably between hospitals (7.5%–74%). Tele EMS ECG usage in STEMI was associated with shorter door to reperfusion time (BB 11min, p<0.04, BE 12min, p<0.001) compared to STEMI care w/o ECG transmission. The difference was more pronounced during hospital off-hours (BB 30min, p=0.003 and BE 14min, p<0.001). An unmistaken EMS STEMI diagnosis related to a shorter door to reperfusion time (BE: by 106min; BB: by 49min) compared to an unsettled STEMI diagnosis (p<0.001). The rate of ECG transmission for STEMI patients in BE was 21.4%, in BB 55.7%. Accordingly, we found no significant difference in STEMI door to reperfusion delays between the reference period and the intervention period in BE (+1min) and a shorter reperfusion delay (by 11min) in BB (p=0.049). Conclusions The universal implementation of a joint intervention to improve STEMI care in a complex system of various EMS and hospital departments is challenging. Telemedical ECG transmission and an unmistaken early STEMI diagnosis are associated with a significantly shorter time delay to myocardial reperfusion.

Computer model and code sharing practices in healthcare discrete-event simulation: a systematic scoping review

ABSTRACT Discrete-event simulation (DES) is a widely used computational method in health services and health economic studies. This scoping review investigates to what extent authors share DES models and audits if sharing adheres to best practice. The Web of Science, Scopus, PubMed, and ACM Digital Library databases were searched between January 1 2019 till December 31 2022. Cost-effectiveness, health service research and methodology studies in a health context were included. Data extraction and audit were performed by two reviewers. We measured the proportion of literature that shared models; we report analyses by publication type, year of publication, COVID-19 application; and free and open source versus commercial software. Out of the 564 studies included, 47 (8.3%) cited a published computer model, rising to 9.0% in 2022. Studies were more likely to share models if they had been developed using free and open source tools. Studies rarely followed best practice when sharing computer models. Although still in the minority, healthcare DES authors are increasingly sharing their computer model artefacts. Although commercial software dominates the DES literature, free and open source software plays a crucial role in sharing. The DES community can adopt simple best practices to improve the quality of sharing.

Mixed Methods Studies in Health Services Research: Requirements, Challenges and the Question of Integration - a Discussion Paper from the Perspective of Qualitative Researchers

With this discussion paper, the subgroup Mixed Methods of the working group Qualitative Research Methods in the non-profit organization German Network Health Services Research (DNVF) is taking up the topic of three previous discussion papers on the significance and potentials of qualitative research methods in health services research. Mixed methods are being increasingly used and demanded in health services research. However, there are also areas of conflict in the planning and implementation of mixed methods studies, and these are addressed in this paper from the perspective of qualitative research. Special attention is given to the aspect of integration as the fundamental signature of mixed methods research. With this discussion paper, our aim was to stimulate critical as well as constructive exchange of ideas on what constitutes high-quality health services research characterised by a diversity of methods and the framework conditions under which this can succeed.

Treatment of intermediate-risk prostate cancer with active surveillance in the routine care-Long-term outcomes of a prospective noninterventional study (HAROW).

We report here the long-term outcomes of patients with intermediate-risk prostate cancer (PCa) treated with active surveillance (AS) in a daily routine setting. HAROW (2008-2013) was a noninterventional, health service research study investigating the management of localized PCa in a community setting. A substantial proportion of the study centers were office-based urologists. A follow-up examination of all intermediate-risk patients with AS was conducted. Overall, cancer-specific, metastasis-free, and treatment-free survival rates, as well as reasons for discontinuation, were determined and discussed. Of the 2957 patients enrolled, 52 with intermediate-risk PCa were managed with AS and were available for evaluation. The median follow-up was 6.8 years (interquartile range, 3.4-8.6 years). Seven patients (13.5%) died of causes unrelated to PCa, of whom 4 were under AS or under watchful waiting. Two patients (3.8%) developed metastasis. The estimated 8-year overall, cancer-specific, metastasis-free, and treatment-free survival rates were 85% (95% confidence interval [CI], 72%-96%), 100%, 93% (95% CI, 82%-100%), and 31% (95% CI, 17%-45%), respectively. On multivariable analysis, prostate-specific antigen density of ≥0.2 ng/mL2 was significantly predictive of receiving invasive treatment (hazard ratio, 3.29; p = 0.006). Reasons for discontinuation were more often due to patient's or physician's concerns (36%) than due to observed clinical progression. Although survival outcome data for intermediate-risk patients managed with AS in real-life health care conditions were promising, rates of discontinuation were high, and discontinuation was often a patient's decision, even when the signs of disease progression were absent. This might be an indication of higher levels of mental burden and anxiety in this specific subgroup of patients, which should be considered when making treatment decisions. From a psychological perspective, not all intermediate-risk patients are optimal candidates for AS.

Health Services in Huntington Disease: A Systematic Literature Review.

Clinical trials for Huntington disease (HD) have primarily focused on managing chorea and, more recently, the development of disease-modifying therapies (DMTs). Nonetheless, understanding health services among patients with HD is essential for assessing new therapeutics, development of quality metrics, and overall quality of life of patients and families with HD. Health services assess health care utilization patterns, outcomes, and health care-associated costs, which can help shape the development of therapeutics and aid in policies that affect patients with a specific condition. In this systematic literature review, we analyze data of published studies looking at causes of hospitalization, outcomes, and health care costs in HD. The search yielded 8 articles published in the English language and comprising data from the United States, Australia, New Zealand, and Israel. The most common cause of hospitalization among patients with HD was dysphagia or dysphagia-related complications (e.g., aspiration pneumonia or malnutrition), followed by psychiatric or behavioral symptoms. Patients with HD had more prolonged hospitalizations than non-HD patients, and it was most prominent among those with advanced disease. Patients with HD were more likely to be discharged to a facility. A small percentage received inpatient palliative care consultation, and behavioral symptoms were a primary cause of discharge to another facility. Interventions such as gastrostomy tube placement had associated morbidity, and it was common among patients with HD with a diagnosis of dementia. Palliative care consultation and specialized nursing care were associated with more routine discharges and fewer hospitalizations. In terms of cost, patients with HD with private and public insurances had the highest expenditure with more advanced disease, and expenses were associated with hospitalization and medication costs. In addition to DMTs, HD clinical trial development should also consider the leading causes of hospitalization, morbidity, and mortality in patients with HD, including dysphagia and psychiatric disease. No research study, to our knowledge, has systematically reviewed health services research studies in HD. Evidence from health services research is needed to evaluate the efficacy of pharmacologic and supportive therapies. This type of research is also critical in understanding health care costs associated with the disease and to better advocate and shape policies that can benefit this patient population.

Applying cognitive task analysis to health services research.

Designing practical decision support tools and other health care technology in health services research relies on a clear understanding of the cognitive processes that underlie the use of these tools. Unfortunately, methods to explore cognitive processes are rarely used in health services research. Thus, the objective of this manuscript is to introduce cognitive task analysis (CTA), a family of methods to study cognitive processes involved in completing a task, to a health services research audience. This methods article describes CTA procedures, proposes a framework for their use in health services research studies, and provides an example of its application in a pilot study. Observations and interviews of health care providers involved in discharge planning at six hospitals in the Veterans Health Administration. Qualitative study of discharge planning using CTA. Data were collected from structured observations and semi-structured interviews using the Critical Decision Method and analyzed using thematic analysis. We developed an adaptation of CTA that could be used in a clinical environment to describe clinical decision-making and other cognitive processes. The adapted CTA framework guides the user through four steps: (1) Planning, (2) Environmental Analysis, (3) Knowledge Elicitation, and (4) Analyses and Results. This adapted CTA framework provides an iterative and systematic approach to identifying and describing the knowledge, expertise, thought processes, procedures, actors, goals, and mental strategies that underlie completing a clinical task. A better understanding of the cognitive processes that underly clinical tasks is key to developing health care technology and decision-support tools that will have a meaningful impact on processes of care and patient outcomes. Our adapted framework offers a more rigorous and detailed method for identifying task-related cognitive processes in implementation studies and quality improvement. Our adaptation of this underutilized qualitative research method may be helpful to other researchers and inform future research in health services research.

Ambulante Spezialfachärztliche Versorgung (ASV): eine multiperspektivische Studie zu Status quo, Herausforderungen und Perspektiven

BackgroundIn 2012, the so-called ambulatory medical specialist care (ASV) was implemented in accordance with para. 116b of Book V of the German Social Code (SGB V), enabling physicians in outpatient practices and hospitals to treat patients with rare diseases or complex courses of disease in a uniform framework. The implementation, however, is slow. The Joint Federal Committee (G-BA) has therefore commissioned an evaluation of the ASV with the aim to examine the reasons for this and to provide recommendations for further development. MethodsThe health services research study “GOAL-ASV” (Innovation Fund, 01VSF19002) included a multi-perspective design with primary data collection as well as secondary data analyses. Data from the ASV service center and the central association of statutory health insurances and the notification forms of the extended state committees were analyzed. Data from the Robert Koch-Institute, the Federal Joint Committee, the National Association of Statutory Health Insurance Funds and a literature database analysis were used in order to estimate the proportion of insured persons qualifying for ASV. Care was examined by analyzing pseudonymized routine data from the statutory health insurances using selected indicators. Participating and not participating physicians were asked to complete an online survey. ResultsSince the start of ASV, 615,531 insured persons have been treated in this form of care. At the time of analysis, 509 teams were operating, with 26,540 physicians treating 102,898 patients by the end of March 2021 in all indications. This comprises less than 9.8 %. of all approx. 1.05 million eligible patients. Especially in the case of rare diseases, a low willingness of participation can be seen. In addition, there was a relevant proportion of multiple uses of physicians within and outside ASV at 31 percent as well as indications of passive participation of doctors. We found significant regional differences in type and scope of the notification procedure as well as the implementation of teams with 13.4 teams per 1 million inhabitants in Schleswig-Holstein and no team in Mecklenburg-Vorpommern. Patient benefits (84 %), interdisciplinary (82 %) and cross-sectoral cooperation (75 %) were cited as motivations for participation. The main barriers reported by the respondents were the complex and laborious notification procedure (60 %), the administrative and documentation effort during participation (50 %), insufficient billing figures (49 %), and a small proportion of patients (32 %) with a consecutively unfavorable assessment of the cost to income ratio due to the current reimbursement system. DiscussionNearly ten years after its introduction, the ASV has not become established nationwide. The reasons for this probably are the complex notification procedure and the reimburesement system for rare diseases. In the case of rare diseases, the risk of underuse is becoming apparent. ConclusionStrategies to further develop the ASV should, in particular, simplify the notification procedure and reduce the obstacles during participation. The remuneration system should take more account of the specific care required.

The role of collaborative learning in resilience in healthcare—a thematic qualitative meta-synthesis of resilience narratives

BackgroundTo provide high quality services in increasingly complex, constantly changing circumstances, healthcare organizations worldwide need a high level of resilience, to adapt and respond to challenges and changes at all system levels. For healthcare organizations to strengthen their resilience, a significant level of continuous learning is required. Given the interdependence required amongst healthcare professionals and stakeholders when providing healthcare, this learning needs to be collaborative, as a prerequisite to operationalizing resilience in healthcare. As particular elements of collaborative working, and learning are likely to promote resilience, there is a need to explore the underlying collaborative learning mechanisms and how and why collaborations occur during adaptations and responses. The aim of this study is to describe collaborative learning processes in relation to resilient healthcare based on an investigation of narratives developed from studies representing diverse healthcare contexts and levels.MethodsThe method used to develop understanding of collaborative learning across diverse healthcare contexts and levels was to first conduct a narrative inquiry of a comprehensive dataset of published health services research studies. This resulted in 14 narratives (70 pages), synthesised from a total of 40 published articles and 6 PhD synopses. The narratives where then analysed using a thematic meta-synthesis approach.ResultsThe results show that, across levels and contexts, healthcare professionals collaborate to respond and adapt to change, maintain processes and functions, and improve quality and safety. This collaboration comprises activities and interactions such as exchanging information, coordinating, negotiating, and aligning needs and developing buffers. The learning activities embedded in these collaborations are both activities of daily work, such as discussions, prioritizing and delegation of tasks, and intentional educational activities such as seminars or simulation activities.ConclusionsBased on these findings, we propose that the enactment of resilience in healthcare is dependent on these collaborations and learning processes, across different levels and contexts. A systems perspective of resilience demands collaboration and learning within and across all system levels. Creating space for reflection and awareness through activities of everyday work, could support individual, team and organizational learning.

Implementing public involvement throughout the research process-Experience and learning from the GPs in EDs study.

Public involvement in health services research is encouraged. Descriptions of public involvement across the whole research cycle of a major study are uncommon and its effects on research conduct are poorly understood. This study aimed to describe how we implemented public involvement, reflect on process and effects in a large-scale multi-site research study and present learning for future involvement practice. We recorded public involvement roles and activities throughout the study and compared these to our original public involvement plan included in our project proposal. We held a group interview with study co-applicants to explore their experiences, transcribed the recorded discussion and conducted thematic analysis. We synthesized the findings to develop recommendations for future practice. Public contributors' activities went beyond strategic study planning and management to include active involvement in data collection, analysis and dissemination. They attended management, scrutiny, planning and task meetings. They also facilitated public involvement through annual planning and review sessions, conducted a Public Involvement audit and coordinated public and patient input to stakeholder discussions at key study stages. Group interview respondents said that involvement exceeded their expectations. They identified effects such as changes to patient recruitment, terminology clarification and extra dissemination activities. They identified factors enabling effective involvement including team and leader commitment, named support contact, building relationships and demonstrating equality and public contributors being confident to challenge and flexible to meet researchers' timescales and work patterns. There were challenges matching resources to roles and questions about the risk of over-professionalizing public contributors. We extended our planned approach to public involvement and identified benefits to the research process that were both specific and general. We identified good practice to support effective public involvement in health services research that study teams should consider in planning and undertaking research. This paper was co-conceived, co-planned and co-authored by public contributors to contribute research evidence, based on their experiences of active involvement in the design, implementation and dissemination of a major health services research study.

Military Health System Opioid, Tramadol, and Gabapentinoid Prescription Volumes Before and After a Defense Health Agency Policy Release

Clinical practice guidelines (CPGs) and health system policies to mitigate inappropriate opioid prescribing practices may have an extended impact on low-dose opioid (e.g., tramadol) and non-opioid (e.g., gabapentinoid) pain medication prescribing practices. To evaluate changes in opioid, tramadol, and gabapentinoid prescribing rates from January 2016 to February 2020 within the Military Health System, including the degree to which prescribing rates changed after release of a US Defense Health Agency Procedural Instruction. In this observational health services research study, opioid, tramadol, and gabapentin prescription dispense events of US Military Health System beneficiaries enrolled in care at military treatment facilities prior to US Defense Health Agency Procedural Instruction release (January 2016-May 2018) were used to forecast values from the post-intervention period (June 2018-February 2020). The median opioid and tramadol prescribing rates decreased from January 2016 to February 2020, aside from tramadol prescribing in Surgery Clinics, which increased. Gabapentinoid prescribing rate changes were mixed. In Bayesian time series models, the forecasted proportion of patients receiving each of the three medications, regardless of age group or clinic type, did not significantly vary from the actual prescribing rates in the post-intervention period. Overall, CPGs and policies targeting opioid prescribing practices may have provided the maximal impetus for providers to re-evaluate their prescribing practices, as the policy did not appear to change the slope in prescribing rates. However, it is unclear whether the policies mitigated the likelihood of plateaus in prescribing rates. Further work is needed to assess the degree to which providers simultaneously altered other non-opioid pain medication prescribing practices, self-management recommendations, and non-pharmacological therapy referrals.

Musculoskeletal healthcare at a Swiss university hospital chiropractic medicine outpatient clinic in 2019: a health services research study

BackgroundThe Balgrist University Hospital in Zurich, Switzerland, is an academic hospital focused on musculoskeletal disorders. An integrated chiropractic medicine clinic provides chiropractic care to a broad patient population. This health services research study aims to advance understanding of chiropractic healthcare service for quality assurance and healthcare quality improvement.MethodsWe performed an observational clinical cohort study at the Balgrist chiropractic medicine outpatient clinic in 2019. The records of all patients with initial visits or returning initial visits (> 3 months since last visit) and their subsequent visits from January 1, 2019, to December 31, 2019, were used to create the study dataset. Data collected included demographic characteristics, diagnoses, imaging data, conservative treatments, surgeries, and other clinical care data. Descriptive statistics were used to summarize data.Results1844 distinct patients (52% female, mean age 48 ± 17 years) were eligible and included in the study. 1742 patients had a single initial visit, 101 had 2 initial visits, and 1 patient had 3 initial visits during the study period (total of 1947 initial visit records). The most common main diagnoses were low back pain (42%; 95% CI 40–46%), neck pain (22%; 20–24%), and thoracic pain (8%; 7–9%). 32% of patients presented with acute (< 4 weeks) symptoms, 11% subacute (4–12 weeks), and 57% chronic (> 12 weeks). Patients had a median of 5 chiropractic visits during their episode of care within a median of 28 days duration. Only 49% (95% CI 47–52%) of patient records had a clinical outcome that was extractable from routine clinical documentation in the hospital information system.ConclusionThis health services study provides an initial understanding of patient characteristics and healthcare delivered in a Swiss academic hospital chiropractic outpatient setting and areas for improved clinical data quality assurance. A more concerted effort to systematically collect patient reported outcome measures would be a worthwhile healthcare quality improvement initiative.

Developing a checklist for reporting research using simulated patient methodology (CRiSP): a consensus study.

Simulated patients are increasingly used to measure outcomes in health services but reporting is suboptimal. This study aims to create a checklist for the reporting of simulated patient (SP) methodology. This was a Delphi study. The authors of health service research studies using SP methodology were invited to participate. Round 1 questionnaire assessed the applicability of the TIDieR (Template for Intervention Description and Replication) reporting checklist for SP methodology and asked for rewording of/additional items. Responses were thematically analysed to generate Round 2 items in which participants rated each item for importance (seven-point Likert scale) and median, mode and IQR were calculated. In Round 3, participants were invited to rescore their Round 2 responses. Consensus was defined as an IQR ≤ 1 (Extremely important) and median ≤ 2 (Very important). All consensus items were considered for inclusion in the checklist. Similarly, worded items were rationalised and items not specific to SP methodology or other existing checklists were excluded. Twenty-nine authors participated in Round 1 and a further seven for Rounds 2 and 3. Twenty-six responses were analysed for Round 1, 30 for Round 2 and 28 for Round 3. There was consensus on 29 of 54 items in Round 2 and 45 of 63 items in Round 3. The final checklist comprised 28 items. A new reporting checklist to guide the reporting of studies, using simulated patients, complementary to CONSORT or STROBE, has been developed and will now be tested for usability.

Quality assessment with diverse studies (QuADS): an appraisal tool for methodological and reporting quality in systematic reviews of mixed- or multi-method studies

BackgroundIn the context of the volume of mixed- and multi-methods studies in health services research, the present study sought to develop an appraisal tool to determine the methodological and reporting quality of such studies when included in systematic reviews. Evaluative evidence regarding the design and use of our existing Quality Assessment Tool for Studies with Diverse Designs (QATSDD) was synthesised to enhance and refine it for application across health services research.MethodsSecondary data were collected through a literature review of all articles identified using Google Scholar that had cited the QATSDD tool from its inception in 2012 to December 2019. First authors of all papers that had cited the QATSDD (n=197) were also invited to provide further evaluative data via a qualitative online survey. Evaluative findings from the survey and literature review were synthesised narratively and these data used to identify areas requiring refinement. The refined tool was subject to inter-rater reliability, face and content validity analyses.ResultsKey limitations of the QATSDD tool identified related to a lack of clarity regarding scope of use of the tool and in the ease of application of criteria beyond experimental psychological research. The Quality Appraisal for Diverse Studies (QuADS) tool emerged as a revised tool to address the limitations of the QATSDD. The QuADS tool demonstrated substantial inter-rater reliability (k=0.66), face and content validity for application in systematic reviews with mixed, or multi-methods health services research.ConclusionOur findings highlight the perceived value of appraisal tools to determine the methodological and reporting quality of studies in reviews that include heterogeneous studies. The QuADS tool demonstrates strong reliability and ease of use for application to multi or mixed-methods health services research.

Abstract PS18-35: Disparities in reporting of race and participation by race in genomic studies

Abstract Background: Black/African American(B/AA) women are more likely to die of breast cancer as compared to White (Wh) women but are underrepresented in genomic research. Current genomic research that aims to classify breast cancer in order to personalize treatment in early breast cancer or to identify targets for therapy in advanced breast cancer fails to adequately represent B/AA women and other minority groups. This negatively impacts our current knowledge of breast cancer in non-Wh women and raises questions about the applicability of such testing in minority groups. Objective: To evaluate the frequency of race reporting and representation of non-White women in genomic studies. Methods: This a database study of all PubMed reported genomic testing studies to classify breast cancer for prognostic or predictive purposes. A PubMed search was conducted with articles from inception to the present with the following keyword search terms: “Breast Cancer Gene Expression Assay” AND “Race”, “PAM50” AND “Race”, “MammaPrint” AND “Race”, “Oncotype Dx” AND “Race”, “76 gene prognostic score” AND “Race”, Intrinsic Subtype” AND “Breast Cancer” AND “Race”. This search yielded 129 articles. 31 articles were removed due to lack of relevance. Results: Of the 98 articles remaining after applying inclusion/exclusion criteria, 39 (40%) failed to report race in their analysis. Of the remaining 59 articles, 57 (96.61%) included Wh participants in their study, 54 (91.53%) included B/AA participants, 13 (22.04%) included Hispanics/Latinos, and 20 (33.90%) included Asians. Two of the major clinical trials of widely used testing such as Oncotype Dx and MammaPrint but did not report race in the pivotal studies. The genomic studies that included B/AA women were more likely to be health services research studies. The genomic studies that focused on triple-negative breast cancer (TNBC) were also more likely to have B/AA participants that ranged from 6%-52% of participants. For Oncotype Dx testing, B/AA women were more likely to have a later stage at diagnosis. While the number of patients with low risk was similar in all race groups, B/AA women were more likely to have high Ki-67 with uncertain significance of these findings. Conclusions: A significant number of genomic studies did not report race and ethnicity. Racial and ethnic minorities continue to be under-represented in genomic research and this raises questions about the wider applicability of this research in these populations. Large clinical studies should specifically report the race and ethnicity of participants to inform decision making. In addition, funders should require reporting of race in genomic studies. Citation Format: Niloufar R Khanna, Niharika Dixit. Disparities in reporting of race and participation by race in genomic studies [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS18-35.

Active Surveillance for Incidental (cT1a/b) Prostate Cancer: Long-Term Outcomes of the Prospective Noninterventional HAROW Study

Introduction: Optimal treatment for incidental prostate cancer (IPC) after surgical treatment for benign prostate obstruction is still debatable. We report on long-term outcomes of IPC patients managed with active surveillance (AS) in a German multicenter study. Methods: HAROW (2008–2013) was designed as a noninterventional, prospective, health-service research study for patients with localized prostate cancer (≤cT2), including patients with IPC (cT1a/b). A follow-up examination of all patients treated with AS was carried out. Overall, cancer-specific, and metastasis-free survival and discontinuation rates were determined. Results: Of 210 IPC patients, 68 opted for AS and were available for evaluation. Fifty-four patients had cT1a category and 14 cT1b category. Median follow-up was 7.7 years (IQR: 5.7–9.1). Eight patients died of which 6 were still under AS or watchful waiting (WW). No PCa-specific death could be observed. One patient developed metastasis. Twenty-three patients (33.8%) discontinued AS changing to invasive treatment: 12 chose radical prostatectomy, 7 radiotherapy, and 4 hormonal treatment. Another 19 patients switched to WW. The Kaplan-Meier estimated 10-year overall, cancer-specific, metastasis-free, and intervention-free survival was 83.8% (95% CI: 72.2–95.3), 100%, 98.4% (95% CI: 95.3–99.9), and 61.0% (95% CI: 47.7–74.3), respectively. In multivariable analysis, age (RR: 0.97; p < 0.001), PSA density ≥0.2 ng/mL² (RR: 13.23; p < 0.001), and PSA ≥1.0 ng/mL after surgery (RR: 5.19; p = 0.016) were significantly predictive for receiving an invasive treatment. Conclusion: In comparison with other AS series with a general low-risk prostate cancer population, our study confirmed the promising survival outcomes for IPC patients, whereas discontinuation rates seem to be lower for IPC. Thus, IPC patients at low risk of progression may be good candidates for AS.

Impact of ICD-9-CM to ICD-10-CM coding transition on trauma hospitalization trends among young adults in 12 states

BackgroundWe aimed to estimate the impact of the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) coding transition on traumatic injury-related hospitalization trends among young adults across a geographically and demographically diverse group of U.S. states.MethodsInterrupted time series analyses were conducted using statewide inpatient databases from 12 states and including traumatic injury-related hospitalizations in adults aged 19–44 years in 2011–2017. Segmented regression models were used to estimate the impact of the October 2015 coding transition on external cause of injury (ECOI) completeness (percentage of hospitalizations with a documented ECOI code) and on population-level rates of injury-related hospitalizations by nature, intent, mechanism, and severity of injury.ResultsThe transition to ICD-10-CM was associated with a drop in ECOI completion in the transition month (− 3.7%; P < .0001), but there was no significant change in the positive trend in ECOI completion from the pre- to post-transition periods. There were significant increases post-transition in the measured rates of hospitalization for traumatic brain injury (TBI), unintentional injury, mild injury (injury severity score (ISS) < 9), and injuries caused by drowning, firearms, machinery, other pedestrian, suffocation, and unspecified mechanism. Conversely, there were significant decreases in October 2015 in the rates of hospitalization for assault, injuries of undetermined intent, injuries of moderate severity (ISS 9–15), and injuries caused by fire/burn, other pedal cyclist, other transportation, natural/environmental, and other specified mechanism. A significant increase in the percentage of hospitalizations classified as resulting from severe injury (ISS > 15) was observed when the general equivalence mapping maximum severity method for converting ICD-10-CM codes to ICD-9-CM codes was used. State-specific results for the outcomes of ECOI completion and TBI-related hospitalization rates are provided in an online supplement.ConclusionsThe U.S. transition from ICD-9-CM to ICD-10-CM coding led to a significant decrease in ECOI completion and several significant changes in measured rates of injury-related hospitalizations by injury intent, mechanism, nature, and severity. The results of this study can inform the design and analysis of future traumatic injury-related health services research studies that use both ICD-9-CM and ICD-10-CM coded data.Level of evidenceII (Interrupted Time Series)

Long-term outcomes of active surveillance for clinically localized prostate cancer in a community-based setting: results from a prospective non-interventional study

PurposeTo report on long-term outcomes of patients treated with active surveillance (AS) for localized prostate cancer (PCa) in the daily routine setting.MethodsHAROW (2008–2013) was a non-interventional, health service research study about the management of localized PCa in the community setting, with 86% of the study centers being office-based urologists. A follow-up examination of all patients who opted for AS as primary treatment was carried out. Overall, cancer-specific, and metastasis-free survival, as well as discontinuation rates, were determined.ResultsOf 329 patients, 62.9% had very-low- and 21.3% low-risk tumours. The median follow-up was 7.7 years (IQR 4.7–9.1). Twenty-eight patients (8.5%) died unrelated to PCa, of whom 19 were under AS or watchful waiting (WW). Additionally, seven patients (2.1%) developed metastasis. The estimated 10-year overall and metastasis-free survival was 86% (95% CI 81.7–90.3) and 97% (95% CI 94.6–99.3), respectively. One hundred eighty-seven patients (56.8%) discontinued AS changing to invasive treatment: 104 radical prostatectomies (RP), 55 radiotherapies (RT), and 28 hormonal treatments (HT). Another 50 patients switched to WW. Finally, 37.4% remained alive without invasive therapy (22.2% AS and 15.2% WW). Intervention-free survival differed between the risk groups: 47.8% in the very-low-, 33.8% in the low- and 34.6% in the intermediate-/high-risk-group (p = 0.008). On multivariable analysis, PSA-density ≥ 0.2 ng/ml2 was significantly predictive for receiving invasive treatment (HR 2.55; p = 0.001).ConclusionEven in routine care, AS can be considered a safe treatment option. Our results might encourage office-based urologists regarding the implementation of AS and to counteract possible concerns against this treatment option.