Evidence inventory: A patient-centered framework for Centers for Medicare & Medicaid Services to assess the clinical benefit of drugs to inform its maximum fair price negotiation.

The Inflation Reduction Act passed in August 2022 empowers the Centers for Medicare & Medicaid Services (CMS) to negotiate maximum fair prices for certain expensive drugs. In the process of determining maximum fair prices, CMS gathers evidence on the clinical benefits of these drugs as compared with their therapeutic alternative(s) from various sources. As patients are the primary beneficiaries of the treatment, we recommend that CMS should embrace an approach that prioritizes patient experience when evaluating such diverse sources of evidence in the assessment of the clinical benefit. Thus, we propose to draw on several existing frameworks to support the concept of "evidence inventory," a patient-centered approach to systematically evaluate benefits of drugs under consideration. This 4-step process to develop an evidence inventory includes the following: (1) Formulate the research question-in a PICO(T) (P = population, I = Intervention or exposure, C = comparator, O = outcome, and T = time frame) format, (2) Synthesize evidence, (3) Evaluate the evidence-using evidence inventory, and (4) Reevaluate evidence as new information become available. Patients and other relevant stakeholders play a critical role in each of these 4 steps. The proposed evidence inventory holds the potential to provide a structured and transparent patient-centered framework for evaluating the clinical benefits of drugs as compared with their therapeutic alternative(s) informing CMS maximum fair price negotiation.

Ability of Caprini and Padua risk-assessment models to predict venous thromboembolism in a nationwide Veterans Affairs study.

OBJECTIVE: Venous thromboembolism (VTE) is a preventable complication of hospitalization. Risk-stratification is the cornerstone of prevention. The Caprini and Padua are two of the most commonly used risk-assessment models (RAMs) to quantify VTE risk. Both models perform well in select, high-risk cohorts. Although VTE RAMs were designed for use in all hospital admissions, they are mostly tested in select, high-risk cohorts. We aim to evaluate the two RAMs in a large, unselected cohort of patients. METHODS: We analyzed consecutive first hospital admissions of 1,252,460 unique surgical and non-surgical patients to 1298 Veterans Affairs facilities nationwide between January 2016 and December 2021. Caprini and Padua scores were generated using the Veterans Affairs' national data repository. We determined the ability of the two RAMs to predict VTE within 90 days of admission. In secondary analyses, we evaluated prediction at 30 and 60 days, in surgical vs non-surgical patients, after excluding patients with upper extremity deep vein thrombosis, in patients hospitalized ≥72 hours, after including all-cause mortality in a composite outcome, and after accounting for prophylaxis in the predictive model. We used area under the receiver operating characteristic curves (AUCs) as the metric of prediction. RESULTS: A total of 330,388 (26.4%) surgical and 922,072 (73.6%) non-surgical consecutively hospitalized patients (total N = 1,252,460) were analyzed. Caprini scores ranged from 0 to 28 (median, 4; interquartile range [IQR], 3-6); Padua scores ranged from 0-13 (median, 1; IQR, 1-3). The RAMs showed good calibration and higher scores were associated with higher VTE rates. VTE developed in 35,557 patients (2.8%) within 90 days of admission. The ability of both models to predict 90-day VTE was low (AUCs: Caprini, 0.56; 95% confidence interval [CI], 0.56-0.56; Padua, 0.59; 95% CI, 0.58-0.59). Prediction remained low for surgical (Caprini, 0.54; 95% CI, 0.53-0.54; Padua, 0.56; 95% CI, 0.56-0.57) and non-surgical patients (Caprini, 0.59; 95% CI, 0.58-0.59; Padua, 0.59; 95% CI, 0.59-0.60). There was no clinically meaningful change in predictive performance in any of the sensitivity analyses. CONCLUSIONS: Caprini and Padua RAM scores have low ability to predict VTE events in a cohort of unselected consecutive hospitalizations. Improved VTE RAMs must be developed before they can be applied to a general hospital population.

Age-stratified comparison of active surveillance versus radiofrequency ablation for papillary thyroid microcarcinoma using decision analysis.

BACKGROUND: Papillary thyroid microcarcinomas may be treated with radiofrequency ablation, active surveillance, or surgery. The objective of this study was to use mathematical modeling to compare treatment alternatives for papillary thyroid microcarcinomas among those who decline surgery. We hypothesized that radiofrequency ablation would outperform active surveillance in avoiding progression and surgery but that the effect size would be small for older patients. METHODS: We engaged stakeholders to identify meaningful long-term endpoints for papillary thyroid microcarcinoma treatment-(1) cancer progression/surgery, (2) need for thyroid replacement therapy, and (3) permanent treatment complication. A Markov decision analysis model was created to compare the probability of these endpoints after radiofrequency ablation or active surveillance for papillary thyroid microcarcinomas and overall cost. Transition probabilities were extracted from published literature. Model outcomes were estimated to have a 10-year time horizon. RESULTS: The primary outcome yielded a number needed to treat of 18.1 for the avoidance of progression and 27.4 for the avoidance of lifelong thyroid replacement therapy for radiofrequency ablation compared to active surveillance. However, as patient age increased, the number needed to treat to avoid progression increased from 5.2 (age 20-29) to 39.1 (age 60+). The number needed to treat to avoid lifelong thyroid replacement therapy increased with age from 7.8 (age 20-29) to 59.3 (age 60+). The average 10-year cost/treatment for active surveillance and radiofrequency ablation were $6,400 and $11,700, respectively, translating to a cost per progression-avoided of $106,500. CONCLUSION: As an alternative to active surveillance, radiofrequency ablation may have a greater therapeutic impact in younger patients. However, routine implementation may be cost-prohibitive for most patients with papillary thyroid microcarcinomas.

Impact of different interventions on preventing suicide and suicide attempt among children and adolescents in the United States: a microsimulation model study.

Introduction: Despite considerable investment in suicide prevention since 2001, there is limited evidence for the effect of suicide prevention interventions among children and adolescents. This study aimed to estimate the potential population impact of different interventions in preventing suicide-related behaviors in children and adolescents. Methods: A microsimulation model study used data from national surveys and clinical trials to emulate the dynamic processes of developing depression and care-seeking behaviors among a US sample of children and adolescents. The simulation model examined the effect of four hypothetical suicide prevention interventions on preventing suicide and suicide attempt in children and adolescents as follows: (1) reduce untreated depression by 20, 50, and 80% through depression screening; (2) increase the proportion of acute-phase treatment completion to 90% (i.e., reduce treatment attrition); (3) suicide screening and treatment among the depressed individuals; and (4) suicide screening and treatment to 20, 50, and 80% of individuals in medical care settings. The model without any intervention simulated was the baseline. We estimated the difference in the suicide rate and risk of suicide attempts in children and adolescents between baseline and different interventions. Results: No significant reduction in the suicide rate was observed for any of the interventions. A significant decrease in the risk of suicide attempt was observed for reducing untreated depression by 80%, and for suicide screening to individuals in medical settings as follows: 20% screened: -0.68% (95% credible interval (CI): -1.05%, -0.56%), 50% screened: -1.47% (95% CI: -2.00%, -1.34%), and 80% screened: -2.14% (95% CI: -2.48%, -2.08%). Combined with 90% completion of acute-phase treatment, the risk of suicide attempt changed by -0.33% (95% CI: -0.92%, 0.04%), -0.56% (95% CI: -1.06%, -0.17%), and -0.78% (95% CI: -1.29%, -0.40%) for reducing untreated depression by 20, 50, and 80%, respectively. Combined with suicide screening and treatment among the depressed, the risk of suicide attempt changed by -0.27% (95% CI: -0.dd%, -0.16%), -0.66% (95% CI: -0.90%, -0.46%), and -0.90% (95% CI: -1.10%, -0.69%) for reducing untreated depression by 20, 50, and 80%, respectively. Conclusion: Reducing undertreatment (the untreated and dropout) of depression and suicide screening and treatment in medical care settings may be effective in preventing suicide-related behaviors in children and adolescents.

Eliciting Low-Risk Thyroid Cancer Treatment Preferences Using Clinical Vignettes: A Pilot Study.

OBJECTIVE: While surgical resection has been the traditional standard treatment for small (≤1 cm), differentiated thyroid cancers, active surveillance (AS) and radiofrequency ablation (RFA) are increasingly considered. The aim of this study was to explore patient preferences in thyroid cancer treatment using a series of clinical vignettes. METHODS: Thyroid cancer survivors and general population volunteers were recruited to rank experience-driven clinical vignettes in order of preference. Rankings were compared using Wilcoxon signed rank. Formative qualitative methods were used to develop and refine clinical vignettes that captured 4 treatments-thyroid lobectomy (TL), total thyroidectomy (TT), AS, and RFA-along with 6 treatment complications. Content was validated via interviews with 5 academic subspecialists. RESULTS: Nineteen volunteers participated (10 survivors, 9 general population). Treatment complications were ranked lower than uncomplicated counterparts in 99.0% of cases, indicating excellent comprehension. Counter to our hypothesis, among uncomplicated vignettes, median rankings were 1 for AS, 2 for RFA, 3.5 for TL, and 5 for TT. Trends were consistent between thyroid cancer survivors and the general population. AS was significantly preferred over RFA (P = .02) and TT (P < .01). Among surgical options, TL was significantly preferred over TT (P < .01). CONCLUSION: When treatments for low-risk thyroid cancer are described clearly and accurately through clinical vignettes, patients may be more likely to choose less invasive treatment options over traditional surgical resection.

Ability of Caprini and Padua Risk-Assessment Models to Predict Venous Thromboembolism in a Nationwide Study.

Background: Venous thromboembolism (VTE) is a preventable complication of hospitalization. Risk-stratification is the cornerstone of prevention. The Caprini and Padua are the most commonly used risk-assessment models to quantify VTE risk. Both models perform well in select, high-risk cohorts. While VTE risk-stratification is recommended for all hospital admissions, few studies have evaluated the models in a large, unselected cohort of patients. Methods: We analyzed consecutive first hospital admissions of 1,252,460 unique surgical and non-surgical patients to 1,298 VA facilities nationwide between January 2016 and December 2021. Caprini and Padua scores were generated using the VA's national data repository. We first assessed the ability of the two RAMs to predict VTE within 90 days of admission. In secondary analyses, we evaluated prediction at 30 and 60 days, in surgical versus non-surgical patients, after excluding patients with upper extremity DVT, in patients hospitalized ≥72 hours, after including all-cause mortality in the composite outcome, and after accounting for prophylaxis in the predictive model. We used area under the receiver-operating characteristic curves (AUC) as the metric of prediction. Results: A total of 330,388 (26.4%) surgical and 922,072 (73.6%) non-surgical consecutively hospitalized patients (total n=1,252,460) were analyzed. Caprini scores ranged from 0-28 (median, interquartile range: 4, 3-6); Padua scores ranged from 0-13 (1, 1-3). The RAMs showed good calibration and higher scores were associated with higher VTE rates. VTE developed in 35,557 patients (2.8%) within 90 days of admission. The ability of both models to predict 90-day VTE was low (AUCs: Caprini 0.56 [95% CI 0.56-0.56], Padua 0.59 [0.58-0.59]). Prediction remained low for surgical (Caprini 0.54 [0.53-0.54], Padua 0.56 [0.56-0.57]) and non-surgical patients (Caprini 0.59 [0.58-0.59], Padua 0.59 [0.59-0.60]). There was no clinically meaningful change in predictive performance in patients admitted for ≥72 hours, after excluding upper extremity DVT from the outcome, after including all-cause mortality in the outcome, or after accounting for ongoing VTE prophylaxis. Conclusions: Caprini and Padua risk-assessment model scores have low ability to predict VTE events in a cohort of unselected consecutive hospitalizations. Improved VTE risk-assessment models must be developed before they can be applied to a general hospital population.

Association of individual low-income status and area deprivation with mortality in multiple myeloma.

INTRODUCTION: Lower individual-level socioeconomic status (SES) and area-level SES have each been associated with poor survival outcomes among patients with multiple myeloma (MM). A body of literature suggests that individual-level SES may be differentially associated with mortality depending on area-level SES, and vice versa. This study assessed the effect of the cross-level interaction between individual low-income status and area deprivation on mortality among patients with MM. MATERIALS AND METHODS: This retrospective cohort study used the Surveillance, Epidemiology, and End Results (SEER)-Medicare data (2006-2016). Individuals were defined as having low income if they were dually eligible for Medicare and Medicaid and/or if they received the Low-Income Subsidy. The county-level Social Deprivation Index (SDI) was linked to individual-level SEER-Medicare data and categorized into quintiles, from the least deprived (Quintile 1) to the most deprived (Quintile 5). Adjusted hazard ratios (HRs) for the associations between low-income status, area deprivation, and all-cause mortality were estimated from a mixed-effects Cox proportional-hazards (PH) model. RESULTS: The mortality hazard was higher for individuals with low income than individuals without low income in all quintiles of area deprivation, with the exception of Quintile 5 (Quintile 1: HR 1.53 [95% confidence interval [CI]: 1.32-1.77]; Quintile 2: HR 1.17 [95%CI: 1.01-1.36]; Quintile 3: HR 1.34 [95%CI: 1.18-1.53]; Quintile 4: HR 1.33 [95%CI: 1.17-1.52]; Quintile 5: HR 1.09 [95%CI: 0.96-1.23]). Among individuals without low income, individuals residing in the most deprived area had a higher mortality hazard than individuals residing in the least deprived area (HR: 1.22 [95%CI: 1.03-1.45]). In contrast, among individuals with low income, residing in a more deprived area, Quintile 2, was associated with a lower hazard of death than residing in the least deprived area, Quintile 1 (HR: 0.82 [95%CI: 0.67-0.99]), and there was no statistically significant difference between Quintile 1 and Quintiles 3, 4, and 5. DISCUSSION: In this analysis, there was a statistically significant cross-level interaction between individual low-income status and area deprivation on mortality. More research is needed to fully understand the mechanism behind these associations, but the findings show that patients and their health should be considered in the context of where they live.

Impact of Undertreatment of Depression on Suicide Risk Among Children and Adolescents With Major Depressive Disorder: A Microsimulation Study.

Undertreatment of depression is common among children and adolescents, but evidence of the impact of undertreatment of depression on risk of suicide is limited due to the low base rate of suicide in the population and lack of sufficient data sources. We developed a microsimulation model that uses evidence from multiple sources to study the impact of different durations of antidepressant treatment on suicide risk in a synthesized sample that is nationally representative of children and adolescents with major depressive disorder. Compared with receiving no treatment, suicide rate and risk of suicide attempt both decreased with increasing duration of antidepressant treatment (for 12 weeks, suicide rate ratios = 0.78 (95% credible interval (CrI): 0.58, 1.15), 36 weeks, 0.65 (95% CrI: 0.44, 0.90), and 52 weeks, 0.63 (95% CrI: 0.45, 0.72); for suicide attempt: 12 weeks, suicide risk ratios = 0.68 (95% CrI: 0.62, 0.69), 36 weeks, 0.56 (95% CrI: 0.52, 0.57), and 52 weeks, 0.55 (95% CrI: 0.51, 0.56). The suicide rate and risk of suicide attempt were lower in children than in adolescents. Males had a lower risk of suicide attempt but higher suicide rate than females. The findings from the microsimulation model show that completion of 12-36 weeks of antidepressant treatment may reduce suicide attempt and suicide among children and adolescents with major depressive disorder.

Total thyroidectomy is more cost-effective than radioactive iodine as an alternative to antithyroid medication for Graves' disease.

BACKGROUND: Patients with Graves' disease treated with radioactive iodine report worse quality of life than those treated by thyroidectomy. However, radioactive iodine is often selected due to lower risk of complications and lower cost. The objective of this study was to estimate the cost-effectiveness of radioactive iodine versus total thyroidectomy for treatment of Graves' disease. METHODS: A Markov decision-analytic model was created to simulate clinical outcomes and costs of medication-refractory Graves' disease treated with radioactive iodine or total thyroidectomy. Complication rates and utilities were derived from published data. Costs were extracted from national Medicare reimbursement rates. We conducted 1-way, 2-way, and probabilistic sensitivity analyses to identify factors that influence cost-effectiveness and reflect uncertainty in model parameters. The willingness-to-pay threshold was set at $100,000/quality-adjusted life-years. RESULTS: Total thyroidectomy yielded 23.6 quality-adjusted life-years versus 20.9 quality-adjusted life-years for radioactive iodine. The incremental cost-effectiveness ratio was $2,982 per quality-adjusted life-years, indicating that surgery is highly cost-effective relative to radioactive iodine. Surgery was more cost effective than radioactive iodine in 88.2% of model simulations. Sensitivity analyses indicate that the model outcomes are driven predominantly by posttreatment quality of life, with contributing effects from rates of treatment complications and the impact of these complications on quality of life. CONCLUSION: For patients with Graves' disease who either cannot tolerate or are refractory to antithyroid drugs, thyroidectomy is more cost-effective than radioactive iodine. Future research should validate reported differences in quality of life between these 2 treatment modalities.

Constructing Health State Descriptions for Low-Risk Thyroid Cancer: Stakeholder Engagement and Formative Qualitative Research.

OVERVIEW: This paper describes stakeholder involvement and formative qualitative research in the creation of health state descriptions (HSDs) or vignettes for low-risk thyroid cancer. The aim of this project was to engage stakeholders in the contribution of a novel set of HSDs, an important first step in the process of assessing value in thyroid cancer health states. METHODS: We draw upon formative, descriptive qualitative methods, following a multi-stage framework of data collection. We conducted individual semi-structured interviews, cognitive interviews, and focus groups with thyroid cancer patients, community providers, academic subspecialists, and participants with no thyroid cancer diagnosis (N = 31). The HSDs went through several iterations over the course of a year, in collaboration with a highly engaged community advisory board, laying the groundwork for HSDs that are comprehensible, comparable, and appropriate for stated-preference research. FINDINGS: Thyroid cancer survivors compared their experiences with those described in the HSDs. Feedback included concern for the emotional well-being of study participants who would be reading them. Providers were attuned to the need for clinical accuracy and made suggestions to reflect their clinical experience, including for patients with complications or disease progression. The pilot participants with no thyroid cancer were particularly valuable in promoting the need to simplify language and maximize readability. DISCUSSION: Stakeholder engagement was critical to being responsive to feedback as the iterations were refined and presented. Continuous engagement and consultation with multiple sources strengthened the HSDs. A secondary outcome from this project is that stakeholders expressed interest in adapting the HSDs into decision aids for people newly diagnosed with low-risk thyroid cancer.

Preferences for Treatments for Major Depressive Disorder: Formative Qualitative Research Using the Patient Experience.

OBJECTIVES: The goals of this formative research are to elicit attributes of treatment and desired outcomes that are important to individuals with major depressive disorder (MDD), to develop a stated preference instrument, and to pre-test the instrument. METHODS: A three-phase survey study design elicited the patient's journey with MDD to design and pre-test the discrete choice experiment (DCE) instrument. Participants were 20 adults aged ≥ 18 with MDD who did not also have bipolar disorder or post-partum depression. We engaged patient advocates and a multi-disciplinary stakeholder advisory group to select and refine attributes for inclusion in a DCE instrument. The DCE was incorporated into a survey that also collected depression treatment and management and sociodemographic characteristics. The DCE was pre-tested with ten adults with MDD. RESULTS: Six attributes were included in the DCE: mode of treatment (medicine only, psychotherapy only, all modalities including brain stimulation), time to treatment effect (6, 9, 12 weeks), days of hopefulness (2, 4, 6 days/week), effect on productivity (40%, 60%, 90% increase), relations with others (strained, improved, no impact), and out-of-pocket costs ($30, $60, $90/month). The DCE test led to the refinement of mode of treatment (medicine, medicine and psychotherapy, and all modalities); time to treatment effect (4, 6, 9 weeks); monthly out-of-pocket costs ($30, $90, $270). CONCLUSIONS: MDD treatment preferences revealed trade-offs among mode of treatment, time to treatment effect, functional outcomes, and cost. The findings demonstrate the potential for meaningfully incorporating the patient experience in preference measures.

Economic burden of interstitial lung disease in a commercially insured population with Sjögren syndrome in the United States.

BACKGROUND: Patients with Sjögren syndrome (SjS) have substantial cost burden on the health care system; among these patients, those who develop interstitial lung disease (ILD) experience poorer quality of life and have a higher mortality risk. However, the economic burden of ILD has not been documented. OBJECTIVE: To estimate the direct health care costs associated with ILD among patients with SjS in a representative sample of the commercially insured population in the United States. METHODS: Individuals with a diagnosis of SjS between January 1, 2006, and September 30, 2015, with and without a diagnosis of ILD, were identified from the PharMetrics Plus for Academics database. The index date was defined as the later date of the first claim with a diagnosis of SjS or the first claim with a diagnosis of ILD for individuals with SjS and ILD (SjS-ILD), and the first claim with a diagnosis of SjS for SjS-only controls. All baseline variables were measured in the 180 days preindex period. A 5:1 propensity score matching was applied to controls for baseline demographic and geographic variables. The cost ratio and average marginal effect for total direct medical costs comparing SjS patients with and without ILD were estimated using a generalized linear model. Costs per health care resource utilization category were also reported. All costs were represented from a health plan payer perspective and inflated to 2020 US dollars. RESULTS: After applying the inclusion criteria, 815 SjS-ILD cases were identified and matched to 4,075 SjS-only controls based on the 5:1 propensity score matching procedure. The 180-day total cost of SjS-ILD cases was about 2 times higher compared with that of SjS-only controls (adjusted cost ratio = 1.95; 95% CI = 1.76-2.15). The average difference in total cost between patients with and without ILD was $8,814 (95% CI = $7,149-$10,479). Costs were mainly contributed from outpatient services other than physician office visit (such as radiological and pathological tests), inpatient services, and outpatient pharmacy cost components for both groups (39.4%, 38.8%, and 16.3% for SjS-ILD cases; 43.7%, 22.6%, and 22.9% for SjS-only controls, respectively). CONCLUSIONS: Total direct health care cost was substantially higher in patients with SjS and ILD compared with patients with SjS without ILD. Our findings provide the foundation for further economic evaluation for preventive strategies to reduce the clinical and economic burden imposed by ILD among patients with SjS.

Economic burden of comorbidities among COPD Patients hospitalized for acute exacerbations: an analysis of a commercially insured population.

INTRODUCTION: This study quantifies costs associated with comorbid conditions among adults diagnosed with chronic obstructive pulmonary disease (COPD) who experience acute exacerbations (AECOPD) needing inpatient hospitalization. METHODS: This retrospective cohort study used 2006-2015 IQVIA PharMetrics® Plus data, a health plan claims database. Patients aged 40-64 years, with AECOPD, defined as an inpatient hospitalization for a COPD-related diagnosis were included. The impact of comorbidities on AECOPD costs (costs of the COPD-related inpatient stay plus healthcare services used 30 days post-discharge) was determined using multivariable regression. The models adjusted for clinical complications, previous utilization, age, sex, region, year, length of hospitalization, and season of admission. RESULTS: Among these COPD patients, 89.5% had at least 1 comorbidity. The mean cost for AECOPD was 2015 US $19,687 (SD: 27,035, median: 11,539). Congestive heart failure, lipid disorders, cancer, and presence of any of the 10 most frequent comorbidities were associated with $1,921 (95% confidence interval (CI): 977-2,866), $1,619 (95% CI: 967-2,272), $8,347 (95% CI: 7,236-9,458), and $4,433 (95% CI: 3,598-5,268) higher costs, respectively than corresponding individuals without these comorbid conditions. Patients with depressive disorders were associated with $1,592 (95% CI: 828-2,355) lower costs compared to those without depressive disorders. CONCLUSION: COPD comorbidity imposes a significant economic burden on AECOPD.

Population Decline in COPD Admissions During the COVID-19 Pandemic Associated with Lower Burden of Community Respiratory Viral Infections.

BACKGROUND: The Coronavirus disease 2019 (COVID-19) pandemic has led to widespread implementation of public health measures, such as stay-at-home orders, social distancing, and masking mandates. In addition to decreasing spread of severe acute respiratory syndrome coronavirus 2, these measures also impact the transmission of seasonal viral pathogens, which are common triggers of chronic obstructive pulmonary disease (COPD) exacerbations. Whether reduced viral prevalence mediates reduction in COPD exacerbation rates is unknown. METHODS: We performed retrospective analysis of data from a large, multicenter health care system to assess admission trends associated with community viral prevalence and with initiation of COVID-19 pandemic control measures. We applied difference-in-differences analysis to compare season-matched weekly frequency of hospital admissions for COPD prior to and after implementation of public health measures for COVID-19. Community viral prevalence was estimated using regional Centers for Disease Control and Prevention test positivity data and correlated to COPD admissions. RESULTS: Data involving 4422 COPD admissions demonstrated a season-matched 53% decline in COPD admissions during the COVID-19 pandemic, which correlated to community viral burden (r = 0.73; 95% confidence interval, 0.67-0.78) and represented a 36% greater decline over admission frequencies observed in other medical conditions less affected by respiratory viral infections (incidence rate ratio 0.64; 95% confidence interval, 0.57-0.71, P < .001). The post-COVID-19 decline in COPD admissions was most pronounced in patients with fewer comorbidities and without recurrent admissions. CONCLUSION: The implementation of public health measures during the COVID-19 pandemic was associated with decreased COPD admissions. These changes are plausibly explained by reduced prevalence of seasonal respiratory viruses.

Prioritization and Refinement of Patient-Informed Value Elements as Attributes for Chronic Obstructive Pulmonary Disease Treatment Preferences.

BACKGROUND AND OBJECTIVE: Formative research studies can inform stated-preference instrument development to quantify the importance of various attributes of healthcare treatments. The objective of this study was to elicit from patients with chronic obstructive pulmonary disease the prioritization of an established set of patient-informed value elements. METHODS: Using an iterative mixed-methods study design, we engaged individuals living with chronic obstructive pulmonary disease in Phase 1 value element elicitation and Phase 2 language refinement. Study participants were recruited from March to July 2019. Four guided activities, administered in an online instrument, elicited individual preferences for 40 disease-agnostic value elements that were aligned with treatment, outcomes, or care process. Responses from the guided activities were summarized and then presented to a patient advocate and additional patient participants for further refinement of the value elements and the phrasing. RESULTS: Twenty-three participants, 18 male and five female, mean age of 66 years (standard deviation = 7) were enrolled in Phase 1. Participant responses informed the selection of eight elements as the key candidates for the Phase 2 language refinement: Side Effects, New Therapeutic Option, Available Treatment, Appropriateness of Care, Predictable Healthcare Needs, Physical Activities: Endurance and Symptom Control, and Explanation of Treatment. With feedback from a patient advocate and additional patient participants, elements were refined, rephrased, or modified and this list was narrowed to six value elements (Side Effects, New Therapeutic Option, Willingness to Pay, Physical Activities, Explanation of Treatment, and Access to Care) to serve as attributes in a conceptual framework for a future quantitative stated-preference instrument. CONCLUSIONS: This patient-engaged formative work identified patients with chronic obstructive pulmonary disease key attributes of value-based decision making that underpin benefit-risk trade-offs between physical endurance, treatment side effects, care access, and cost. This study illustrates an iterative process for eliciting and refining a comprehensive list of value elements, resulting in a subgroup of elements important to a specific patient population.

Exploring the Use of State Medical Cannabis Legislation as a Proxy for Medical Cannabis Use Among Patients Receiving Chemotherapy.

OPINION STATEMENT: The use of medical cannabis is expanding in the USA. Due to conflicting, low-quality evidence, many oncologists may not feel confident to recommend it to patients. Given the potential for legal and financial risks when conducting clinical trials with medical cannabis, the use of observational data should be explored. Observational data that directly capture medical cannabis use in relation to prescription medications and track the prevalence and patterns of cannabis use is sparse. To gain insights into the role medical cannabis plays in the pharmaceutical landscape, proxies such as cannabis legislation need to be explored. In the context of recommendation-nonadherent antiemetic prescribing among patients experiencing chemotherapy-induced nausea and vomiting, medical cannabis may be a suitable alternative to an antiemetic in states that allow medical cannabis. Findings suggest that legislation may impact the use of certain antiemetics in states with cannabis legislation in place. The presence or absence of legislation regarding medical cannabis use may serve as an early, observable surrogate marker of medical cannabis use in the community. In light of the paucity of clinical trials and observational datasets that capture cannabis use, there remains a tremendous need for the development of methodologies or standardized datasets that appropriately and reliably capture the use of medical cannabis to facilitate research into its clinical application and effect on prescription medication use. Standardizing the reporting and destigmatizing use could eliminate the dependence upon proxy measures as a substitute for more extensive data and go a long way in improving data capture, thus allowing us to generate knowledge and hypotheses from observational data until research conditions improve and allow for expanded clinical trials involving medical cannabis.