Center For Outcomes Research Research Articles

PP132 Health Technology Assessment Agencies’ Expectations Regarding Patient Experience Data in Australia, China, And Japan

IntroductionHealth technology assessment (HTA) agencies are increasingly embracing patient experience data (PED) to support reimbursement decisions. This study aimed to review HTA agencies’ expectations with regards to utilizing PED to support drug reimbursement in Australia, Japan, and China.MethodsPublished HTA guidance documents were reviewed in 2021 to identify any PED-specific information. If available, recommendations related to the type of PED (e.g., generic vs. disease-specific clinical outcomes assessment (COA)); COA validation, analyses, endpoints and interpretation; and the interest in PED beyond COA in HTA decision-making (e.g., patient preference information) were reviewed. Literature review and semi-structured interviews with key opinion leaders (KOLs) were conducted to further explore these themes and future trends with regards to PED.ResultsAustralia’s Pharmaceutical Benefits Advisory Committee guidance document includes a dedicated section on patient-reported outcomes (PRO), providing details on preferred PRO instruments; validation expectations; and recommended methods to explore score interpretation, assess and report PRO results and handle missing data. While PED derived from non-PRO sources are not discussed in the guidance, the KOL noted that they should not be ruled out. Japan’s Center for Outcomes Research and Economic Evaluation for Health guideline includes a section dedicated to PROs without details related to instrument validation, analyses and interpretation, however, is focused on the use of PRO to inform health economic assessments. In China, the HTA center of China National Health Commission drafted two disease-specific technical guidance documents recommending the inclusion of PROs in efficacy assessments and use of instruments relevant in the Chinese population; these points were echoed by the KOL interviewed.ConclusionsThere are recommendations on PED use included in country-specific guidance documents, however their level of detail varies greatly. Knowing each agency’s expectations with regards to PED is key when submitting HTA evidence dossiers and should be considered early in clinical trial design to integrate market access perspectives and optimize drug development.

0820 Integrated Polysomnographic and Sleep Symptom-Based Cluster Subtypes Associated with Incident Atrial Fibrillation

Abstract Introduction While sleep disorders are implicated in atrial fibrillation (AF), the interplay and overlap of these disorders in AF risk remains unclear and a risk stratification challenge. Sleep-based clusters associated with AF can account for this complexity and translate to actionable approaches to identify at-risk patients. We hypothesized discrete phenotypes of symptoms and polysomnography (PSG)-based data differ in relation to incident AF. Methods Cleveland Clinic patients (age>18) who underwent PSG 11/27/2004-12/30/2015 were retrospectively examined. Clusters were identified using latent class analysis of 23 symptoms (e.g. related to sleep disordered breathing (SDB), sleepiness, REM intrusion, NREM parasomnias), Epworth Sleepiness Scale (ESS) score, and 24 measures of SDB and sleep architecture from PSG reports. Outcome was 5-year incident AF. Cox-proportional hazards models were adjusted for age, sex, race, body mass index, cardiovascular disease and risk factors, tobacco use, chronic obstructive pulmonary disease, anti-arrhythmic medication use, and positive airway pressure use. Results The sample included 43,433 patients: age 51.8±14.5, 51.9% (n=22,548) male, 74.4% (n=32,313) White, 7.3% (n=3,151) with baseline AF, and 4.3% (n=1,875) developed 5-year incident AF. Five clusters were identified and ranked by strength of AF association: 1) Hypoxemic (n=3,245): highest %time SaO2< 90% (T90), 2) Apneas+Arousals (n=4,592): most witnessed apneas, highest apnea hypopnea index (AHI), highest arousal index, least hypopneas, 3) Short sleep+NREM (n=6,126): shortest sleep time, longest REM latency, lowest %REM, 4) Hypopneas (n=2,661): most hypopneas, 5) Long sleep+REM (n=26,809): longest sleep time, shortest REM latency, highest %REM. Compared to ‘Long sleep+REM’, ‘Hypoxemic’ had 47% higher AF risk (HR=1.47,95%CI=1.27-1.69), and ‘Hypopneas’ did not differ (HR=1.05,95%CI=0.86-1.28). Conclusion Of five clusters identified, the ‘Hypoxemic’ subtype conferred the strongest AF risk with the highest degree of hypoxemia (highest T90, lowest minimum and mean SaO2), maximum end-tidal CO2, heart rate, and ESS score. Consistent with prior evidence of hypoxemia as an AF driver and cardiovascular risk of the sleepy phenotype, this constellation of symptoms and physiologic alterations illustrates risk in the clinical setting, providing potential value as a risk prediction tool. Future investigation should focus on external validation of these findings. Support (if any) Cleveland Clinic Neurological Institute Center for Outcomes Research & Evaluation Pilot Grant, Transformative Research Resource Development Award

PP94 Exploring The Relationship Between Price And Outcome Of The Health-Economic Assessment In Japan

IntroductionThis study reviewed all publicly available Japanese cost-effectiveness appraisals delivered by the Center for Outcomes Research and Economic Evaluation for Health (C2H) from the national institute of public health (NIPH) and analyzed the relationship between the outcomes of the health-economic assessments and the final price adjustment decisions made by the Ministry of Health, Labour and Welfare (MHLW).MethodsData were extracted from all official health-economic assessments published by C2H website for the analysis. The extractions were structured based on the following items: indication, assessment methodology, appropriate comparators, health-economic outcomes, and key uncertainties identified by C2H. The analysis was performed on 29th November 2021. A threshold of 5 million JPY per Quality Adjusted Life Year gained (JPY/QALY) was used for the incremental cost-effectiveness ratio (ICER) analysis cut-off.ResultsUp to the time of this analysis, six health-economic assessments had been conducted for five products: three assessments performed cost-effectiveness analysis, one performed cost-minimization analysis and two performed cost-effectiveness and cost-minimization analysis for different comparators and different patient subgroups respectively. Among the five assessments’ reported ICER values, four of them are under the 5 million JPY/QALY threshold, ranging from 328,585 JPY/QALY to 483,056 JPY/QALY. However, price adjustments were still implemented on three out of the four products which were deemed to be cost-effective, ranging from -0.5 percent to -4.3 percent (mean: -3.0%). For the only product deemed to be not cost-effective, a price adjustment of -4.3 percent was implemented.ConclusionsA price discount could be implemented regardless of whether the ICER value falls under the 5 million JPY/QALY threshold. However, a lower magnitude of price discount is likely to be applied by MHLW for more cost effective treatments. The outcome of this analysis may be limited by the small sample size and continuous monitoring of further HTA publications in Japan is needed.

Cost-effectiveness of insulin degludec/insulin aspart versus biphasic insulin aspart in Chinese population with type 2 diabetes.

To evaluate the long-term cost effectiveness of insulin degludec/insulin aspart (IDegAsp) vs. biphasic insulin aspart 30 (BIAsp 30) for the treatment of people with type 2 diabetes mellitus (T2DM) inadequately managed on basal insulin in China. The CORE (the Center for Outcomes Research) Diabetes Model, which has been published and verified, was used to simulate disease progression and calculate the total direct medical costs, life years (LYs) and quality-adjusted life years (QALYs) over 30 years, from the perspective of Chinese healthcare system. The patient demographic information and clinical data needed for the model were gathered from a phase III treat-to-target clinical trial (NCT02762578) and other Chinese cohort studies. Medical costs on treating diabetes were calculated based on clinical trial and local sources. The diabetes management and complications costs were derived from published literature. A discounting rate of 5% was applied to both health and cost outcomes. And one-way and probabilistic sensitivity analyses were carried out to test the reliability of the results. Compared with BIAsp 30, treatment with IDegAsp was associated with an incremental benefit of 0.001 LYs (12.439 vs. 12.438) and 0.280 QALYs (9.522 vs. 9.242) over a 30-year time horizon, and increased CNY (Chinese Yuan) 3,888 (390,152 vs. 386,264) for total costs. IDegAsp was cost-effective vs. BIAsp 30 therapy with an incremental cost-effectiveness ratio of CNY 13,886 per QALY gained. Results were robust across a range of sensitivity analyses. Compared with BIAsp 30, IDegAsp was a cost-effective treatment option for people with T2DM with inadequate glycemic management on basal insulin in China.

0614 Polysomnographic Measures of Sleep Architectural Disruption and Incident Atrial Fibrillation and Stroke in a Large Clinical Cohort

Abstract Introduction Although epidemiologic studies have identified associations of architectural disruptions in sleep and atrial fibrillation (AF), inconsistencies in results limit understanding of longitudinal AF and stroke development in clinic-based cohorts. We hypothesize lower arousal index as a biomarker of prolonged respiratory events and objective measures of sleep disruption increase incident AF and stroke. Methods Cleveland Clinic patients (age>18) who underwent polysomnogram (PSG) or split studies 11/27/2004-12/30/2015 were examined. Arousal index, total sleep time (TST,hours), sleep efficiency (SE,%), and wake after sleep onset (WASO,hours) were assessed as predictors of incident AF. Cox proportional hazard models were fit with time from sleep study to AF diagnosis. Secondary analyses were conducted in the subset of patients with baseline AF, with time from sleep study to stroke. Covariates included age, sex, race, body mass index (BMI,kg/m2), cardiovascular risk factors (hypertension, diabetes mellitus, hyperlipidemia), heart failure, coronary artery disease, myocardial infarction, coronary artery bypass grafting, chronic obstructive pulmonary disease, tobacco use, and use of anti-arrhythmic drugs. Data were censored at date of last follow up or the 5-year mark. Results The sample comprised 43,634 patients: age 51.7±14.5, 51.9% male, 74.5% White, and 7.1%(n=3,090) with AF. Of those without baseline AF, 1,176(2.9%) developed 5-year incident AF. Incident AF increased by 9% (HR=1.09, 95%CI=1.04-1.13) for each hour of lost TST. For every 10 percentage point decreased SE, incident AF increased by 7% (HR=1.07, 95%CI=1.04-1.11). For every hour increased WASO, incident AF increased by 14% (HR=1.14, 95%CI=1.07-1.21). Arousal index conferred no statistically detectable change of incident AF. In secondary analyses, any association of arousal index and incident stroke was attenuated after accounting for confounding comorbidities (omnibus p=0.055). Conclusion Objective measures of disrupted sleep architecture predicted incident AF in this clinical cohort. However, arousal index was not associated with AF development, nor stroke development in secondary analyses. Further investigation is needed to elucidate the role of arousal in SDB, perhaps with hierarchal models to clarify the degree to which confounders attenuate or accentuate any relationship. Support (If Any) Cleveland Clinic Neurological Institute Center for Outcomes Research & Education Pilot Grant

0745 Sleep-Related Hypoxemia Association with Incident Atrial Fibrillation in a Clinic-Based Cohort

Abstract Introduction Sleep disordered breathing (SDB) has been implicated in atrial fibrillation (AF) in population-based studies, however, its role remains unclear and inconsistent. We hypothesize greater risk of 5-year incident AF with SDB and sleep-related hypoxia in a clinic-based cohort. Methods Cleveland Clinic patients (age>18) who underwent polysomnogram (PSG) or split studies 11/27/2004-12/30/2015 with >3 hours diagnostic time were examined. Predictors include AHI, % sleep time oxygen saturation<90% (T90), and minimum and mean oxygen saturation(minSaO2 and meanSaO2, respectively). Cox proportional hazard models were fit with time from sleep study to AF diagnosis as the dependent variable. Covariates included age, sex, race, body mass index(BMI), cardiovascular risk factors (hypertension, diabetes mellitus, hyperlipidemia), heart failure, coronary artery disease, myocardial infarction, history of coronary artery bypass grafting, chronic obstructive pulmonary disease, tobacco use, and use of anti-arrhythmic drugs. Data were censored at date of last follow up or at 5-years. Results The sample was comprised of 43,634 patients: age 51.7±14.5, 51.9% male, 74.5% White, and 7.1%(n=3,090) with AF. Of those without AF, 1,176(2.9%) developed 5-year incident AF. For each 10% increase in T90, incident AF increased by 7% (HR=1.07, 95%CI=1.05-1.10). Compared to reference, patients with 25.01-50%, 50.01-75%, and 75.01-100% time T90 had 22% (HR=1.22, 95%CI=1.01-1.46), 49% (HR=1.49, 95%CI=1.20-1.85), and 65% (HR=1.65, 95%CI=1.26-2.15) higher incident AF, respectively. For every 10-unit increase in minSaO2 and meanSaO2, incident AF decreased by 11%(HR=0.89, 95%CI=0.83-0.95) and 23% (HR=0.77, 95%CI=0.68-0.86), respectively. AHI did not demonstrate a statistically significant relationship with incident AF at a significance level of 0.05. Conclusion Sleep-related hypoxemia, defined by cumulative burden below 90% SaO2, demonstrated an association with incident AF in this large clinic-based cohort, even considering confounding factors. On the other hand, SDB severity as defined by AHI did not demonstrate this relationship. These findings are consistent with experimental models that identify intermittent hypoxia and oxidative stress leading to alterations of the cardiac substrate, thus implicating sleep-related hypoxemic mechanisms as a salient driver in the evolution of atrial arrhythmogenesis. Support (If Any) Cleveland Clinic Neurological Institute Center for Outcomes Research & Education Pilot Grant, Neuroscience Transformative Research Resource Development Award

Diabetes Screening by Race and Ethnicity in the United States: Equivalent Body Mass Index and Age Thresholds.

Racial/ethnic minority populations in the United States have increased rates of diabetes compared with White populations. The 2021 guidelines from the U.S. Preventive Services Task Force recommend diabetes screening for adults aged 35 to 70 years with a body mass index (BMI) of 25 kg/m2 or greater. To determine the BMI threshold for diabetes screening in major racial/ethnic minority populations with benefits and harms equivalent to those of the current diabetes screening threshold in White adults. Cross-sectional study. NHANES (National Health and Nutrition Examination Survey), 2011 to 2018. Nonpregnant U.S. adults aged 18 to 70 years (n= 19335). A logistic regression model was used to estimate diabetes prevalence at various BMIs for White, Asian, Black, and Hispanic Americans. For each racial/ethnic minority group, the equivalent BMI threshold was defined as the BMI at which the prevalence of diabetes in 35-year-old persons in that group is equal to that in 35-year-old White adults at a BMI of 25 kg/m2. Ranges were estimated to account for the uncertainty in prevalence estimates for White and racial/ethnic minority populations. Among adults aged 35 years with a BMI of 25 kg/m2, the prevalence of diabetes in Asian Americans (3.8% [95% CI, 2.8% to 5.1%]), Black Americans (3.5% [CI, 2.7% to 4.7%]), and Hispanic Americans (3.0% [CI, 2.1% to 4.2%]) was significantly higher than that in White Americans (1.4% [CI, 1.0% to 2.0%]). Compared with a BMI threshold of 25 kg/m2 in White Americans, the equivalent BMI thresholds for diabetes prevalence were 20 kg/m2 (range, <18.5 to 23 kg/m2) for Asian Americans, less than 18.5 kg/m2 (range, <18.5 to 23 kg/m2) for Black Americans, and 18.5 kg/m2 (range, <18.5 to 24 kg/m2) for Hispanic Americans. Sample size limitations precluded assessment of heterogeneity within racial/ethnic groups. Among U.S. adults aged 35 years or older, offering diabetes screening to Black Americans and Hispanic Americans with a BMI of 18.5 kg/m2 or greater and Asian Americans with a BMI of 20 kg/m2 or greater would be equivalent to screening White adults with a BMI of 25 kg/m2 or greater. Using screening thresholds specific to race/ethnicity has the potential to reduce disparities in diabetes diagnosis. Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology.

Editorial introductions

Current Opinion in Rheumatology was launched in 1989. It is one of a successful series of review journals whose unique format is designed to provide a systematic and critical assessment of the literature as presented in the many primary journals. The field of Rheumatology is divided into 15 sections that are reviewed once a year. Each section is assigned a Section Editor, a leading authority in the area, who identifies the most important topics at that time. Here we are pleased to introduce the Journal's Section Editors for this issue. SECTION EDITORS Kenneth G. SaagKenneth G. SaagKenneth G. Saag, MD, MSc, is Jane Knight Lowe Professor of Medicine, Division of Clinical Immunology and Rheumatology, at the University of Alabama at Birmingham (UAB) in Birmingham, Alabama, USA and Professor of Epidemiology, at the UAB School of Public Health. Dr Saag is a native of Chicago, and following studies in engineering at the University of Michigan, USA, he returned to Chicago for medical school and Internal Medicine Residency at Northwestern University, USA. He then traveled to the University of Iowa, USA, for his rheumatology and epidemiology training and remained on the faculty there until moving to UAB in 1998. Dr Saag is the founding Director of the Agency for Health Care Research and Quality Deep South Center for Education and Research on Therapeutics, the UAB Center of Research Translation in Gout and Hyperuricemia, and the UAB Outcomes Research Center. He also serves as a Vice Chair for the UAB Department of Medicine. He has published over 300 peer reviewed manuscripts; has also authored more than 100 reviews, editorials, and book chapters. Recently he published the first edition of the clinical handbook Diagnosis and Management of Osteoporosis. Dr Saag is the Secretary of the American College of Rheumatology (ACR) and Past President of the Board of Trustees of the National Osteoporosis Foundation. Sara K. TedeschiSara K. TedeschiDr Tedeschi is a Rheumatologist at Brigham and Women's Hospital and an Assistant Professor of Medicine at Harvard Medical School, both in Boston, Massachusetts, USA. She completed medical school at Vanderbilt University School of Medicine in Nashville, Tennessee, USA. Dr Tedeschi then completed both her internal medicine residency and rheumatology fellowship training at Brigham and Women's Hospital and received her MPH from the Harvard T.H. Chan School of Public Health. Her clinical research focuses on risk factors for and outcomes in rheumatic diseases. Dr Tedeschi's current work which focuses on calcium pyrophosphate crystal deposition disease is funded by the National Institutes of Health. She is Co-Chair of the OMERACT CPPD Working Group and serves on the leadership team of the ACR/EULAR CPPD Classification Criteria working group. George C. TsokosGeorge C. TsokosDr George C. Tsokos, MD is Professor of Medicine at Harvard Medical School and Chief, Rheumatology Division, Beth Israel Deaconess Medical Center in Boston, USA. He trained in Rheumatology at the National Institutes of Health, USA. He has served various leadership positions including President of the Clinical Immunology Society, Chair of the Council of the University of Athens and Member or Chair of multiple federal study sections and Editor or Member of editorial boards of scientific journals. Dr Tsokos holds a MERIT Award from the National Institutes of Health and has received several prestigious awards including the Kirkland, Howley, Evelyn Hess awards and the Distinguished Basic Investigator Award from the American College of Rheumatology, the Lupus Insight Award, the Carol Nachman International Prize in Rheumatology and the Marian Ropes Physician Achievement Award. Dr Tsokos’ laboratory has opened and led the field of molecular abnormalities on immune cells in patients with SLE and identified previously unknown pathways which have served as the basis for novel treatments which are currently in various phases of development.

Is Value Portable? An Examination of Contextual and Practical Considerations that Affect the Transferability of Value Assessments between Settings.

Abstract Objectives The extent to which value assessments are uniquely deployed in any given geographic setting is variable. Increasingly, markets are seeking insights from external health technology assessments (HTAs) to assist with decisions surrounding the adoption of new technologies. We reviewed the environment, infrastructure, and practice of value assessment in six countries, with a focus on how these elements influence the transferability of value assessments between settings. Methods We reviewed the diverse settings in which six organizations conducting HTA operate, and explored how differences might affect the transferability of value assessment. We focused attention on Australia’s Pharmaceutical Benefits Advisory Committee, China’s National Center for Medicine and HTA, Germany’s Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, Japan’s Center for Outcomes Research and Economic Evaluation for Health (Core 2 Health), the National Institute for Health and Care Excellence in England and Wales, and the Institute for Clinical and Economic Review in the United States. Results HTA is adopted to address unique objectives for a given health system and is tailored to support local standards and preferences. Some elements of a value assessment, such as evidence on clinical effectiveness, may be more transferable than others. It is challenging to appropriately adjust external assessments to the local context. Conclusions Contextual differences influence both the role and application of HTA. These differences limit the transferability of value assessments from one setting to another. De novo appraisals, customized to the local decision context, are the ideal approach to determinations about value.

Editorial Comment.

No AccessJournal of UrologyAdult Urology1 Feb 2022Editorial CommentThis article comments on the following:Survival after Radical Prostatectomy versus Radiation Therapy in High-Risk and Very High-Risk Prostate Cancer Sami Majdalany, and Firas Abdollah Sami MajdalanySami Majdalany Vattikuti Urology Institute Center for Outcomes Research, Analytics and Evaluation (VCORE) Vattikuti Urology Institute, Henry Ford Health System, Detroit, Michigan More articles by this author , and Firas AbdollahFiras Abdollah Vattikuti Urology Institute Center for Outcomes Research, Analytics and Evaluation (VCORE) Vattikuti Urology Institute, Henry Ford Health System, Detroit, Michigan More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002250.02AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail "Editorial Comment." The Journal of Urology, 207(2), p. 384 © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsRelated articlesJournal of UrologySep 24, 2021, 12:00:00 AMSurvival after Radical Prostatectomy versus Radiation Therapy in High-Risk and Very High-Risk Prostate Cancer Volume 207Issue 2February 2022Page: 384-384 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Sami Majdalany Vattikuti Urology Institute Center for Outcomes Research, Analytics and Evaluation (VCORE) Vattikuti Urology Institute, Henry Ford Health System, Detroit, Michigan More articles by this author Firas Abdollah Vattikuti Urology Institute Center for Outcomes Research, Analytics and Evaluation (VCORE) Vattikuti Urology Institute, Henry Ford Health System, Detroit, Michigan More articles by this author Expand All Advertisement PDF DownloadLoading ...

Association of 5-Alpha Reductase Inhibitor Use with Prostate Specific Antigen Level at the Time of Urology Referral in a Retrospective Cohort at a Large, Integrated Health Care System.

5-Alpha reductase inhibitor (5-ARI) use leads to a 50% decline in serum prostate specific antigen (PSA) without a concomitant decrease in prostate cancer (PCa) risk. We hypothesize that failure to account for the effect of 5-ARI use on serum PSA leads to increased PCa risk at urology referral among 5-ARI users. This is a retrospective cohort study for the years 2018-2019. Atrium Health is a large, vertically integrated health system with over 900 care locations in North Carolina and South Carolina. Men ≥40 years old during 2018-2019 who had a PSA test performed were included. We determined differences in corrected serum PSA level at the time of referral to urology. 5-ARI users and nonusers were compared using the chi-square test, Student's t-test and gamma regression. From 2018-2019, there were 91,368 men who underwent PSA testing, including 2,939 5-ARI users. At referral, 5-ARI users had similar uncorrected median PSA (5.8 vs 5.6 ng/ml, p=0.05). After correcting for the effect of 5-ARIs on PSA, 5-ARI users had a median PSA of 11.6 ng/ml at urology referral, compared to 5.6 ng/ml in nonusers. Men taking 5-ARIs have higher corrected serum PSA at time of referral to urology. As the unadjusted PSA at referral to urology for PCa risk was similar between 5-ARI users and nonusers, this indicates that the effect of 5-ARI use on serum PSA levels is not routinely accounted for when assessing PCa risk.

Non-specific pain and 30-day readmission in acute coronary syndromes: findings from the TRACE-CORE prospective cohort

BackgroundPatients with acute coronary syndromes often experience non-specific (generic) pain after hospital discharge. However, evidence about the association between post-discharge non-specific pain and rehospitalization remains limited.MethodsWe analyzed data from the Transitions, Risks, and Actions in Coronary Events Center for Outcomes Research and Education (TRACE-CORE) prospective cohort. TRACE-CORE followed patients with acute coronary syndromes for 24 months post-discharge from the index hospitalization, collected patient-reported generic pain (using SF-36) and chest pain (using the Seattle Angina Questionnaire) and rehospitalization events. We assessed the association between generic pain and 30-day rehospitalization using multivariable logistic regression (N = 787). We also examined the associations among patient-reported pain, pain documentation identified by natural language processing (NLP) from electronic health record (EHR) notes, and the outcome.ResultsPatients were 62 years old (SD = 11.4), with 5.1% Black or Hispanic individuals and 29.9% women. Within 30 days post-discharge, 87 (11.1%) patients were re-hospitalized. Patient-reported mild-to-moderate pain, without EHR documentation, was associated with 30-day rehospitalization (odds ratio [OR]: 2.03, 95% confidence interval [CI]: 1.14–3.62, reference: no pain) after adjusting for baseline characteristics; while patient-reported mild-to-moderate pain with EHR documentation (presumably addressed) was not (OR: 1.23, 95% CI: 0.52–2.90). Severe pain was also associated with 30-day rehospitalization (OR: 3.16, 95% CI: 1.32–7.54), even after further adjusting for chest pain (OR: 2.59, 95% CI: 1.06–6.35).ConclusionsPatient-reported post-discharge generic pain was positively associated with 30-day rehospitalization. Future studies should further disentangle the impact of cardiac and non-cardiac pain on rehospitalization and develop strategies to support the timely management of post-discharge pain by healthcare providers.

Leveraging Remote Physiologic Monitoring in the COVID-19 Pandemic to Improve Care After Cardiovascular Hospitalizations.

Leveraging Remote Physiologic Monitoring in the COVID-19 Pandemic to Improve Care After Cardiovascular Hospitalizations.

Healthcare System Stress Due to Covid‐19: Evading an Evolving Crisis

Journal of Hospital MedicineVolume 16, Issue 2 p. 127-127 Editorial Healthcare System Stress Due to Covid-19: Evading an Evolving Crisis Abraar Karan MD, MPH, Abraar Karan MD, MPH Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MassachusettsSearch for more papers by this authorRishi K Wadhera MD, MPP, MPhil, Corresponding Author Rishi K Wadhera MD, MPP, MPhil rwadhera@bidmc.harvard.edu Richard A and Susan F Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MassachusettsCorresponding Author: Rishi K Wadhera, MD, MPP, MPhil; Email: rwadhera@bidmc.harvard.edu; Telephone: 617-632-7698; Twitter: @rkwadhera; @AbraarKaran.Search for more papers by this author Abraar Karan MD, MPH, Abraar Karan MD, MPH Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MassachusettsSearch for more papers by this authorRishi K Wadhera MD, MPP, MPhil, Corresponding Author Rishi K Wadhera MD, MPP, MPhil rwadhera@bidmc.harvard.edu Richard A and Susan F Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MassachusettsCorresponding Author: Rishi K Wadhera, MD, MPP, MPhil; Email: rwadhera@bidmc.harvard.edu; Telephone: 617-632-7698; Twitter: @rkwadhera; @AbraarKaran.Search for more papers by this author First published: 01 February 2021 https://doi.org/10.12788/jhm.3583Citations: 2Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article.Citing Literature Volume16, Issue2February 2021Pages 127-127 RelatedInformation

Cost-effectiveness evaluation for pricing medicines and devices: A new value-based price adjustment system in Japan.

In Japan, a new cost-effectiveness evaluation system for medicine and medical device pricing was employed in April 2019 after a trial implementation. This study describes the discussions held from April 2016 to March 2019 concerning the newly introduced system. Using published government documents, discussions with stakeholders, and the minutes of the Chuikyo committee meetings, the following issues are addressed: (i) the results of the trial implementation and (ii) an overview of the newly introduced system. During the trial implementation, thirteen products were evaluated and their prices adjusted. The process of the new system-which was to be implemented in FY 2019-takes about 15-18 months to complete after listing of the target products by the National Health Insurance. The target products are selected principally based on sales volume, degree of innovation (premium), and disclosure of rationale for price setting. First, a manufacturer submits the cost-effectiveness data, which is then reviewed by the Center for Outcomes Research and Economic Evaluation for Health (C2H) in collaboration with academics. The results of the cost-effectiveness evaluation are not considered during the decision-making process concerning the product's listing. The price adjustment system is similar to value-based pricing (VBP); hence, the new system can be considered as VBP adjustment. Cost-effectiveness evaluation can help promote both technological innovation and sustainability of the healthcare system. We need to create a greater capacity for enhancing this academic review system.

Provider Burnout and Fatigue During the COVID-19 Pandemic: Lessons Learned From a High-Volume Intensive Care Unit.

Provider Burnout and Fatigue During the COVID-19 Pandemic: Lessons Learned From a High-Volume Intensive Care Unit.

Editorial introductions

Current Opinion in Rheumatology was launched in 1989. It is one of a successful series of review journals whose unique format is designed to provide a systematic and critical assessment of the literature as presented in the many primary journals. The field of Rheumatology is divided into 15 sections that are reviewed once a year. Each section is assigned a Section Editor, a leading authority in the area, who identifies the most important topics at that time. Here we are pleased to introduce the Journal's Section Editors for this issue. SECTION EDITORS Kenneth SaagKenneth SaagKenneth Saag, MD, MSc, is Jane Knight Lowe Professor of Medicine, Division of Clinical Immunology and Rheumatology, at the University of Alabama at Birmingham (UAB) in Birmingham, Alabama, USA and Professor of Epidemiology, at the UAB School of Public Health. Dr Saag is a native of Chicago, and following studies in engineering at the University of Michigan, USA, he returned to Chicago for medical school and Internal Medicine Residency at Northwestern University, USA. He then traveled to the University of Iowa, USA, for his rheumatology and epidemiology training and remained on the faculty there until moving to UAB in 1998. Dr Saag is the founding Director of the Agency for Health Care Research and Quality Deep South Center for Education and Research on Therapeutics, the UAB Center of Research Translation in Gout and Hyperuricemia, and the UAB Outcomes Research Center. He also serves as a Vice Chair for the UAB Department of Medicine. He has published over 300 peer reviewed manuscripts; has also authored more than 100 reviews, editorials, and book chapters. Recently he published the first edition of the clinical handbook Diagnosis and Management of Osteoporosis. Dr Saag is the Secretary of the American College of Rheumatology (ACR) and Past President of the Board of Trustees of the National Osteoporosis Foundation. Sara K. TedeschiSara K. TedeschiDr Tedeschi is a Rheumatologist at Brigham and Women's Hospital and an Assistant Professor of Medicine at Harvard Medical School, both in Boston, Massachusetts, USA. She completed medical school at Vanderbilt University School of Medicine in Nashville, Tennessee, USA. Dr Tedeschi then completed both her internal medicine residency and rheumatology fellowship training at Brigham and Women's Hospital and received her MPH from the Harvard T.H. Chan School of Public Health. Her clinical research focuses on risk factors for and outcomes in rheumatic diseases. Dr Tedeschi's current work which focuses on calcium pyrophosphate crystal deposition disease is funded by the National Institutes of Health. She has received several prestigious awards including the Distinguished Fellow Award from the American College of Rheumatology and election to Alpha Omega Alpha. George C. TsokosGeorge C. TsokosDr George C. Tsokos, MD, is Professor of Medicine at Harvard Medical School and Chief, Rheumatology Division, Beth Israel Deaconess Medical Center in Boston, USA. He trained in Rheumatology at the National Institutes of Health, USA. He has served various leadership positions including President of the Clinical Immunology Society, Chair of the Council of the University of Athens and Member or Chair of multiple federal study sections and Editor or Member of editorial boards of scientific journals. Dr Tsokos holds a MERIT Award from the National Institutes of Health and has received several prestigious awards including the Kirkland, Howley, Evelyn Hess awards and the Distinguished Basic Investigator Award from the American College of Rheumatology, the Lupus Insight Award, the Carol Nachman International Prize in Rheumatology and the Marian Ropes Physician Achievement Award. Dr Tsokos’ laboratory has opened and led the field of molecular abnormalities on immune cells in patients with SLE and identified previously unknown pathways which have served as the basis for novel treatments which are currently in various phases of development.

Religiosity and Patient Activation Among Hospital Survivors of an Acute Coronary Syndrome.

Optimum management after an acute coronary syndrome (ACS) requires considerable patient engagement/activation. Religious practices permeate people's lives and may influence engagement in their healthcare. Little is known about the relationship between religiosity and patient activation. To examine the association between religiosity and patient activation in hospital survivors of an ACS. Secondary analysis using baseline data from Transitions, Risks, and Actions in Coronary Events: Center for Outcomes Research and Education (TRACE-CORE) Study. A total of 2067 patients hospitalized for an ACS at six medical centers in Central Massachusetts and Georgia (2011-2013). Study participants self-reported three items assessing religiosity-strength and comfort from religion, making petition prayers, and awareness of intercessory prayers for health. Patient activation was assessed using the 6-item Patient Activation Measure (PAM-6). Participants were categorized as either having low (levels 1 and 2) or high (levels 3 and 4) activation. The mean age of study participants was 61years, 33% were women, and 81% were non-Hispanic White. Approximately 85% derived strength and comfort from religion, 61% prayed for their health, and 89% received intercessory prayers for their health. Overall, 58% had low activation. Reports of a great deal (aOR, 2.02; 95% CI, 1.44-2.84), and little/some (aOR, 1.45; 95% CI, 1.07-1.98) strength and comfort from religion were associated with high activation, as were receipt of intercessions (aOR, 1.48; 95% CI, 1.07-2.05). Praying for one's health was associated with low activation (aOR, 0.78; 95% CI, 0.61-0.99). Most ACS survivors acknowledge religious practices toward their recovery. Strength and comfort from religion and intercessory prayers for health were associated with high patient activation. Petition prayers for health were associated with low activation. Healthcare providers should use knowledge about patient's religiosity to enhance patient engagement in their care.

Highlights From the Circulation Family of Journals.

Highlights From the Circulation Family of Journals.

Cost-effectiveness of a fixed-dose combination pill for secondary prevention of cardiovascular disease in China, India, Mexico, Nigeria, and South Africa: a modelling study

Fewer than 25% of patients with atherosclerotic cardiovascular disease in countries of low and middle income (LMICs) use guideline-directed drugs for secondary prevention. A fixed-dose combination polypill might improve cardiovascular outcomes by increasing prescription rates and adherence, but the cost-effectiveness of this approach is uncertain. We developed microsimulation models to assess the cost-effectiveness of a polypill containing aspirin, lisinopril, atenolol, and simvastatin for secondary prevention of atherosclerotic cardiovascular disease compared with current care in China, India, Mexico, Nigeria, and South Africa. We modelled baseline use of secondary prevention drugs on the Prospective Urban Rural Epidemiological study. In the intervention arm, we assumed that patients currently prescribed any prevention drug for atherosclerotic cardiovascular disease would receive the polypill instead, which would improve adherence by 32% (from a meta-analysis of two randomised trials in LMICs). We assessed the cost-effectiveness of the polypill at prices in the public sector and on the retail market. Key outcomes were major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) over a 5-year period and the incremental cost-effectiveness ratio (ICER) from the perspective of the health-care sector and a lifetime analytical horizon. We assumed a cost-effectiveness threshold equal to each country's per capita gross domestic product (GDP) per disability-adjusted life-year (DALY) averted. In sensitivity analyses, we examined the population health effect achievable by increasing the uptake of the polypill in the eligible population. Among adults aged 30-84 years with established atherosclerotic cardiovascular disease, adoption of the polypill for secondary prevention compared with current care was projected to avert 40-54 major adverse cardiovascular events for every 1000 patients treated for 5 years and produce between three and ten additional serious adverse events. Assuming public-sector pharmaceutical prices, the ICER of the polypill compared with current care over a lifetime analytical horizon was Int$168 (95% UI 55 to 337) per DALY averted in China, $154 (57 to 289) in India, $88 (15 to 193) in Mexico, $364 (147 to 692) in Nigeria, and $64 (cost-saving to 203) in South Africa, amounting to 0·4-6·2% of the per capita GDP in these countries. The ICER of the polypill compared with current care increased to 3·3-14·6% of the per capita GDP at retail market pharmaceutical prices. Use of the polypill at current rates of prescription of secondary prevention drugs would produce modest health benefits, reducing DALYs from atherosclerotic cardiovascular disease among patients with established disease by 3·1-10·1% over 10 years. Increasing use to 50% or 75% of the eligible population would produce substantially larger health gains (up to 24·3% atherosclerotic cardiovascular disease DALYs averted). The polypill is projected to be cost-effective compared with current care for secondary prevention of atherosclerotic cardiovascular disease in China, India, Mexico, Nigeria, and South Africa, particularly if it is made available at public-sector pricing. However, achieving meaningful improvements in cardiovascular health will require simultaneous investments in health infrastructure to increase the uptake of the polypill among patients with established atherosclerotic cardiovascular disease. Richard A and Susan F Smith Center for Outcomes Research in Cardiology, Hellman Family Foundation, Department of Veterans Affairs, and University of California at San Francisco.