Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma.

BACKGROUND: Black and Latinx patients bear a disproportionate burden of asthma. Efforts to reduce the disproportionate morbidity have been mostly unsuccessful, and guideline recommendations have not been based on studies in these populations. METHODS: In this pragmatic, open-label trial, we randomly assigned Black and Latinx adults with moderate-to-severe asthma to use a patient-activated, reliever-triggered inhaled glucocorticoid strategy (beclomethasone dipropionate, 80 µg) plus usual care (intervention) or to continue usual care. Participants had one instructional visit followed by 15 monthly questionnaires. The primary end point was the annualized rate of severe asthma exacerbations. Secondary end points included monthly asthma control as measured with the Asthma Control Test (ACT; range, 5 [poor] to 25 [complete control]), quality of life as measured with the Asthma Symptom Utility Index (ASUI; range, 0 to 1, with lower scores indicating greater impairment), and participant-reported missed days of work, school, or usual activities. Safety was also assessed. RESULTS: Of 1201 adults (603 Black and 598 Latinx), 600 were assigned to the intervention group and 601 to the usual-care group. The annualized rate of severe asthma exacerbations was 0.69 (95% confidence interval [CI], 0.61 to 0.78) in the intervention group and 0.82 (95% CI, 0.73 to 0.92) in the usual-care group (hazard ratio, 0.85; 95% CI, 0.72 to 0.999; P = 0.048). ACT scores increased by 3.4 points (95% CI, 3.1 to 3.6) in the intervention group and by 2.5 points (95% CI, 2.3 to 2.8) in the usual-care group (difference, 0.9; 95% CI, 0.5 to 1.2); ASUI scores increased by 0.12 points (95% CI, 0.11 to 0.13) and 0.08 points (95% CI, 0.07 to 0.09), respectively (difference, 0.04; 95% CI, 0.02 to 0.05). The annualized rate of missed days was 13.4 in the intervention group and 16.8 in the usual-care group (rate ratio, 0.80; 95% CI, 0.67 to 0.95). Serious adverse events occurred in 12.2% of the participants, with an even distribution between the groups. CONCLUSIONS: Among Black and Latinx adults with moderate-to-severe asthma, provision of an inhaled glucocorticoid and one-time instruction on its use, added to usual care, led to a lower rate of severe asthma exacerbations. (Funded by the Patient-Centered Outcomes Research Institute and others; PREPARE ClinicalTrials.gov number, NCT02995733.).

Consensus palliative care referral criteria for people with chronic obstructive pulmonary disease.

OBJECTIVE: People with advanced chronic obstructive pulmonary disease (COPD) have substantial palliative care needs, but uncertainty exists around appropriate identification of patients for palliative care referral.We conducted a Delphi study of international experts to identify consensus referral criteria for specialist outpatient palliative care for people with COPD. METHODS: Clinicians in the fields of respiratory medicine, palliative and primary care from five continents with expertise in respiratory medicine and palliative care rated 81 criteria over three Delphi rounds. Consensus was defined a priori as ≥70% agreement. A criterion was considered 'major' if experts endorsed meeting that criterion alone justified palliative care referral. RESULTS: Response rates from the 57 panellists were 86% (49), 84% (48) and 91% (52) over first, second and third rounds, respectively. Panellists reached consensus on 17 major criteria for specialist outpatient palliative care referral, categorised under: (1) 'Health service use and need for advanced respiratory therapies' (six criteria, eg, need for home non-invasive ventilation); (2) 'Presence of symptoms, psychosocial and decision-making needs' (eight criteria, eg, severe (7-10 on a 10 point scale) chronic breathlessness); and (3) 'Prognostic estimate and performance status' (three criteria, eg, physician-estimated life expectancy of 6 months or less). CONCLUSIONS: International experts evaluated 81 potential referral criteria, reaching consensus on 17 major criteria for referral to specialist outpatient palliative care for people with COPD. Evaluation of the feasibility of these criteria in practice is required to improve standardised palliative care delivery for people with COPD.

Questions in Mild Asthma: An Official American Thoracic Society Research Statement.

Background: Patients with mild asthma are believed to represent the majority of patients with asthma. Disease-associated risks such as exacerbations, lung function decline, and death have been understudied in this patient population. There have been no prior efforts from major societies to describe research needs in mild asthma. Methods: A multidisciplinary, diverse group of 24 international experts reviewed the literature, identified knowledge gaps, and provided research recommendations relating to mild asthma definition, pathophysiology, and management across all age groups. Research needs were also investigated from a patient perspective, generated in conjunction with patients with asthma, caregivers, and stakeholders. Of note, this project is not a systematic review of the evidence and is not a clinical practice guideline. Results: There are multiple unmet needs in research on mild asthma driven by large knowledge gaps in all areas. Specifically, there is an immediate need for a robust mild asthma definition and an improved understanding of its pathophysiology and management strategies across all age groups. Future research must factor in patient perspectives. Conclusions: Despite significant advances in severe asthma, there remain innumerable research areas requiring urgent attention in mild asthma. An important first step is to determine a better definition that will accurately reflect the heterogeneity and risks noted in this group. This research statement highlights the topics of research that are of the highest priority. Furthermore, it firmly advocates the need for engagement with patient groups and for more support for research in this field.

Risk factors for herpes zoster: should people with asthma or COPD be vaccinated?

Without vaccination, an estimated 1 in 3 individuals will develop herpes zoster (HZ) in their lifetime. Increased risk of HZ is attributed to impaired cell-mediated immunity, as observed in age-related immunosenescence or in individuals immunocompromised due to disease or immunosuppressive treatments. Most vaccination guidelines recommend HZ vaccination in all adults ≥ 50 years of age, although Shingrix® was recently approved by the U.S. Food and Drug Administration for use in individuals aged ≥ 18 years who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy, followed by approval by the European Medicines Agency for use in immunocompromised individuals aged ≥ 18 years. Chronic respiratory diseases are also risk factors for HZ. A new meta-analysis reported 24% and 41% increased risks of HZ in those with asthma and chronic obstructive pulmonary disorder (COPD), respectively, compared with healthy controls. Asthma and COPD increase a person's risk of HZ and associated complications at any age and may be further elevated in those receiving inhaled corticosteroids. Despite the increased risks, there is evidence that HZ vaccination uptake in those aged ≥ 50 years with COPD may be lower compared with the age-matched general population, potentially indicating a lack of awareness of HZ risk factors among clinicians and patients. The 2022 Global Initiative for Chronic Lung Disease report recognizes that Centers for Disease Control and Prevention recommended to vaccinate those aged ≥ 50 years against HZ, although health systems should consider the inclusion of all adults with asthma or COPD into their HZ vaccination programs. Further research into HZ vaccine efficacy/effectiveness and safety in younger populations is needed to inform vaccination guidelines.

What is the context? After experiencing chickenpox, the varicella-zoster virus remains in the body and can be reactivated years later in a form called herpes zoster, more commonly known as shingles. Although shingles is more common in people aged ≥ 50 years, it is also more likely to occur in people with immune systems that do not work normally, which may include those with respiratory conditions such as asthma and chronic obstructive pulmonary disorder (COPD). This disease can be prevented by vaccination. Therefore, it is important for doctors to know which patients are at increased risk of shingles and who could be considered for vaccination. What is new? This review is the first to summarize the risk of shingles in people with asthma or COPD, drawing together evidence from across the world. It also evaluates the recommended use of different shingles vaccines in these patients, with a focus on two widely used vaccines: Zostavax® (ZVL) and Shingrix® (RZV). Asthma or COPD can make people more likely to develop shingles and related medical complications, even in younger people. Most guidelines recommend vaccination against this disease for those aged 50 years and above, with some also recommending vaccination in people aged 18­49 years who may be at higher risk of shingles. There is limited information on the benefit of shingles vaccination in those aged ≤ 50 years with asthma or COPD, but their increased risk of developing shingles suggests they may also benefit from inclusion in vaccination programs. What is the impact? The data presented in the review suggest that people with asthma or COPD aged 18­49 years could benefit from shingles vaccination. This group is not currently included in most vaccination guidelines, despite the evidence of increased risk of shingles and its complications. More information is needed on the risks and benefits of vaccinating this group to determine if it would be cost-effective.

Comparing asthma control assessment using the Asthma Control Test and the Asthma APGAR in African American/Black and Hispanic/Latinx populations.

INTRODUCTION: The objective of this analysis was to compare the Asthma Control Test (ACT) and the Asthma APGAR asthma control assessment tools in African-Ancestry/Black (AA/B) and Hispanic/Latinx (H/L) adults with moderate to severe asthma. METHODS: This pre-planned sub-study of the PREPARE clinical trial compares the baseline ACT and Asthma APGAR scores for the PREPARE populations using correlation coefficients, generalized linear modeling and receiver operating curve (ROC) analyses. Correlations were also assessed for both control tests and the Asthma Symptom Utility Index (ASUI). RESULTS: Among the 1201 adults (603 AA/B and 598 H/L) with moderate to severe asthma, most had uncontrolled asthma by both the ACT and the Asthma APGAR. Correlation coefficients between the ACT, Asthma APGAR and ASUI were strong and did not differ significantly by race/ethnicity. The ACT consistently assessed more patients as uncontrolled compared with the Asthma APGAR. The differences in ACT and Asthma APGAR scores did not differ by age, gender, race/ethnicity, self-reported health literacy or medication adherence but did differ by education level. Both the ACT and Asthma APGAR had similar ROCs for predicting an asthma exacerbation in the next 3 months. CONCLUSIONS: Both the ACT and the Asthma APGAR can be used for asthma control assessment in AA/B and H/L populations with moderate to severe asthma, providing comparable rates of uncontrolled asthma and similar limited ability to predict exacerbations. Further work is required to better understand the basis and clinical implications of the higher rates of uncontrolled asthma identified using the ACT.

Discriminative Accuracy of the CAPTURE Tool for Identifying Chronic Obstructive Pulmonary Disease in US Primary Care Settings.

Importance: Chronic obstructive pulmonary disease (COPD) is underdiagnosed in primary care. Objective: To evaluate the operating characteristics of the CAPTURE (COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk) screening tool for identifying US primary care patients with undiagnosed, clinically significant COPD. Design, Setting, and Participants: In this cross-sectional study, 4679 primary care patients aged 45 years to 80 years without a prior COPD diagnosis were enrolled by 7 primary care practice-based research networks across the US between October 12, 2018, and April 1, 2022. The CAPTURE questionnaire responses, peak expiratory flow rate, COPD Assessment Test scores, history of acute respiratory illnesses, demographics, and spirometry results were collected. Exposure: Undiagnosed COPD. Main Outcomes and Measures: The primary outcome was the CAPTURE tool's sensitivity and specificity for identifying patients with undiagnosed, clinically significant COPD. The secondary outcomes included the analyses of varying thresholds for defining a positive screening result for clinically significant COPD. A positive screening result was defined as (1) a CAPTURE questionnaire score of 5 or 6 or (2) a questionnaire score of 2, 3, or 4 together with a peak expiratory flow rate of less than 250 L/min for females or less than 350 L/min for males. Clinically significant COPD was defined as spirometry-defined COPD (postbronchodilator ratio of forced expiratory volume in the first second of expiration [FEV1] to forced vital capacity [FEV1:FVC] <0.70 or prebronchodilator FEV1:FVC <0.65 if postbronchodilator spirometry was not completed) combined with either an FEV1 less than 60% of the predicted value or a self-reported history of an acute respiratory illness within the past 12 months. Results: Of the 4325 patients who had adequate data for analysis (63.0% were women; the mean age was 61.6 years [SD, 9.1 years]), 44.6% had ever smoked cigarettes, 18.3% reported a prior asthma diagnosis or use of inhaled respiratory medications, 13.2% currently smoked cigarettes, and 10.0% reported at least 1 cardiovascular comorbidity. Among the 110 patients (2.5% of 4325) with undiagnosed, clinically significant COPD, 53 had a positive screening result with a sensitivity of 48.2% (95% CI, 38.6%-57.9%) and a specificity of 88.6% (95% CI, 87.6%-89.6%). The area under the receiver operating curve for varying positive screening thresholds was 0.81 (95% CI, 0.77-0.85). Conclusions and Relevance: Within this US primary care population, the CAPTURE screening tool had a low sensitivity but a high specificity for identifying clinically significant COPD defined by presence of airflow obstruction that is of moderate severity or accompanied by a history of acute respiratory illness. Further research is needed to optimize performance of the screening tool and to understand whether its use affects clinical outcomes.

Risk of, and risk factors for, vasculopathy associated with acute herpes zoster.

OBJECTIVES: We aimed to summarize the known risk of vasculopathy (stroke, myocardial infarction [MI], and transient ischemic attack [TIA]) after herpes zoster (HZ) and the impact of antiviral treatment and vaccination against HZ on the risk of vasculopathy. MATERIALS AND METHODS: A narrative literature review was conducted in PubMed to identify evidence published in the past 15 years that was relevant to the scope of this article. RESULTS: Ten studies reported that HZ was associated with an increased risk of stroke and one UK study reported no association. Four studies reported that HZ was associated with an increased risk of MI, and four reported that HZ was associated with an increased risk of TIA. Two studies reported that antiviral treatment was associated with a reduced risk of stroke and an additional two studies reported no association between antiviral treatment and the risk of stroke. In addition, two studies reported that vaccination against HZ using the live zoster vaccine (ZVL) was associated with a reduced risk of stroke, and an additional two studies reported that the risk of stroke or MI after HZ was similar between ZVL vaccinated and unvaccinated individuals. CONCLUSIONS: HZ is associated with an increased risk of stroke, MI, or TIA (strongest association is between HZ and stroke). Further studies are needed to determine whether antiviral treatment or ZVL vaccination influence the risk of HZ-associated vasculopathy. In addition, the effect of the recombinant zoster vaccine on the risk of HZ-associated vasculopathy should be studied.

COPD Population in US Primary Care: Data From the Optimum Patient Care DARTNet Research Database and the Advancing the Patient Experience in COPD Registry.

PURPOSE: To describe demographic and clinical characteristics of chronic obstructive pulmonary disease patients managed in US primary care. METHODS: This was an observational registry study using data from the Chronic Obstructive Pulmonary Disease (COPD) Optimum Patient Care DARTNet Research Database from which the Advancing the Patient Experience COPD registry is derived. Registry patients were aged ≥35 years at diagnosis. Electronic health record data were collected from both registries, supplemented with patient-reported information/outcomes from the Advancing the Patient Experience registry from 5 primary care groups in Texas, Ohio, Colorado, New York, and North Carolina (June 2019 through November 2020). RESULTS: Of 17,192 patients included, 1,354 were also in the Advancing the Patient Experience registry. Patients were predominantly female (56%; 9,689/17,192), White (64%; 9,732/15,225), current/ex-smokers (80%; 13,784/17,192), and overweight/obese (69%; 11,628/16,849). The most commonly prescribed maintenance treatments were inhaled corticosteroid with a long-acting ß2-agonist (30%) and inhaled corticosteroid with a long-acting muscarinic antagonist (27%). Although 3% (565/17,192) of patitents were untreated, 9% (1,587/17,192) were on short-acting bronchodilator monotherapy, and 4% (756/17,192) were on inhaled corticosteroid monotherapy. Despite treatment, 38% (6,579/17,192) of patients experienced 1 or more exacerbations in the last 12 months. These findings were mirrored in the Advancing Patient Experience registry with many patients reporting high or very high impact of disease on their health (43%; 580/1,322), a breathlessness score 2 or more (45%; 588/1,315), and 1 or more exacerbation in the last 12 months (50%; 646/1,294). CONCLUSIONS: Our findings highlight the high exacerbation, symptom, and treatment burdens experienced by COPD patients managed in US primary care, and the need for more real-life effectiveness trials to support decision making at the primary care level.

Adherence to adding inhaled corticosteroids to rescue therapy in a pragmatic trial with adults with asthma: A pilot study.

BACKGROUND: Underuse of guideline-recommended inhaled corticosteroids (ICS) controller therapy is a risk factor for greater asthma burden. ICS concomitantly used with rescue inhalers (Patient-Activated Reliever-Triggered ICS ['PARTICS']) reduced asthma exacerbations in efficacy trials, but whether PARTICS is effective in pragmatic trials is unknown. OBJECTIVE: We conducted this pilot to determine the feasibility of executing a large-scale pragmatic PARTICS trial and to improve study protocols. METHODS: Four sites recruited 33 Hispanic or black adults with persistent asthma, randomized them approximately 3:1 to intervention or usual care, and followed them for 12 weeks. All participants received asthma guideline-based educational videos; intervention participants received video-based instructions on implementing PARTICS plus usual medications. The study involved 1 randomization visit and monthly questionnaires. Timely questionnaire responses (±2 weeks) were monitored. Participants underwent qualitative phone interviews to assess self-reported adherence to PARTICS and understand barriers to completing study procedures. RESULTS: Timely questionnaire response rates were 61%, 64%, and 70% at 4, 8, and 12 weeks, respectively. Self-reported adherence to PARTICS was 76% (95% confidence interval [CI], 58%-94% [n = 21]), 88% (95%CI, 72%-100% [n = 16]), and 62% (95%CI, 36%-88% [n = 13]) at weeks 1, 6, and 12, respectively. Barriers to completing study procedures included difficulties with questionnaire access, remembering to use ICS and rescue inhalers together, and obtaining refills. Only 22% of participants recognized their short-acting bronchodilator as "reliever" or "rescue." CONCLUSION: Recruitment was feasible within the allocated period. Adherence to PARTICS was incomplete, questionnaire completion was suboptimal, and common rescue inhaler nomenclature usage was limited. We have modified the full study protocol to attempt to improve adherence to PARTICS and minimize barriers to study procedures. CLINICAL TRIALS REGISTRATION: pilot study for 'PeRson EmPowered Asthma Relief' (PREPARE, NCT02995733).

The asthma Symptom Free Days Questionnaire: how reliable are patient responses?

Objective: Symptom free days are a widely used patient-reported outcome (PRO) in asthma clinical trials. We assessed the internal consistency of one instrument for this PRO, the Symptom Free Days Questionnaire (SFDQ), in a population of Black adults with asthma enrolled in the Blacks and Exacerbations on Long-acting beta agonists and Tiotropium (BELT) trial. Methods: We assessed responses to the SFDQ collected at baseline, 6 and 12 months as part of the BELT trial. The internal consistency of responses, specifically number of patient-reported days with symptoms in 14 days were compared to the number of patient-reported days with no symptoms in the same 14 days. Lin concordance correlation coefficients (Lin ccc) were calculated over time to assess "learning" and by age, sex, geographic location, and annual family income. Results: The internal consistency of the responses of the 1070 enrolled patients was consistently low over the 12 months of the study; varying from 43.8% at baseline to 52.1% at 12 months. This corresponded to Lin cccs of 0.33-0.32 over the study period. Internal consistency and the Lin ccc did not vary by age group, sex, geographic location or percent poverty. Concordance was slightly but not significantly higher at all time points in those with family annual income of ≥$50,000 compared to those with lower annual incomes. Conclusions: The SFDQ did not work well in the BELT population of Black adults with asthma. Further validation is required before the SFDQ is used in other large clinical trials with any population.

Susceptibility to exacerbations in Black adults with asthma.

OBJECTIVE: Exacerbations account for much of the morbidity in asthma. In a large intervention study, we sought to test the hypothesis that a Black adult exacerbation-prone phenotype - a group of Black people with asthma who are at high risk of repeat exacerbation within one year - exists in asthma independent of clinical control. METHODS: We analyzed exacerbation risk factors in 536 self-identified Black Americans with asthma eligible for, or on, Step 3 National Asthma Education and Prevention Program (NAEPP) therapy who participated in a randomized 6-18 month trial of tiotropium versus long acting beta agonist as add-on therapy to inhaled corticosteroids. Exacerbations were defined as events treated by oral or systemic corticosteroids. Clinical control was assessed by a validated asthma control questionnaire (ACQ5). RESULTS: Exacerbations became more likely with loss of clinical control. The mean baseline ACQs for exacerbators and non-exacerbators were 2.41 and 1.91, respectively (p < 0.001). The strongest independent factor associated with exacerbations across all ACQ levels was an exacerbation in the preceding year (adjusted OR 3.26; p < 0.001). The severity of prior exacerbations did not correlate with the likelihood of a future exacerbation. Lower baseline FEV1/FVC was also associated with increased risk of exacerbations. CONCLUSIONS: Even though exacerbations increase with loss of clinical control, an exacerbation susceptibility phenotype exists in Black adults with asthma, independent of clinical control. This phenotype requires precision therapeutic targeting.

Use of Asthma APGAR Tools in Primary Care Practices: A Cluster-Randomized Controlled Trial.

PURPOSE: The purpose of this study was to assess patient and practice outcomes after introducing the Asthma APGAR (Activities, Persistent, triGGers, Asthma medications, Response to therapy) tools into primary care practices. METHODS: We used a pragmatic cluster-randomized controlled design in 18 US family medicine and pediatric practices to compare outcomes in patients with persistent asthma aged 5 to 45 years after introduction of the Asthma APGAR tools vs usual care. Patient outcomes included asthma control, quality of life, and emergency department (ED), urgent care, and inpatient hospital visits. The practice outcome was adherence to asthma guidelines. RESULTS: We enrolled 1,066 patients: 245 children, 174 adolescents, and 647 adults. Sixty-five percent (692 patients) completed both baseline and 12-month questionnaires, allowing analysis for patient-reported outcomes. Electronic health record data were available for 1,063 patients (99.7%) for practice outcomes. The proportion of patients reporting an asthma-related ED, urgent care, or hospital visit in the final 6 months of the study was lower in the APGAR practices vs usual care practices (10.6% vs 20.9%, P = .004). The percentage of patients with "in control" asthma increased more between baseline and 1 year in the APGAR group vs usual care group (13.5% vs 3.4%, P =.0001 vs P =.86) with a trend toward better control scores and asthma-related quality of life in the former at 1 year (P ≤.06 and P = .06, respectively). APGAR practices improved their adherence to 3 or more guideline elements compared with usual care practices (20.7% increase vs 1.9% decrease, P = .001). CONCLUSIONS: Introduction of the Asthma APGAR tools improves rates of asthma control; reduces asthma-related ED, urgent care, and hospital visits; and increases practices' adherence to asthma management guidelines.

A New Approach for Identifying Patients with Undiagnosed Chronic Obstructive Pulmonary Disease.

RATIONALE: Chronic obstructive pulmonary disease (COPD) is often unrecognized and untreated. OBJECTIVES: To develop a method for identifying undiagnosed COPD requiring treatment with currently available therapies (FEV1 <60% predicted and/or exacerbation risk). METHODS: We conducted a multisite, cross-sectional, case-control study in U.S. pulmonary and primary care clinics that recruited subjects from primary care settings. Cases were patients with COPD and at least one exacerbation in the past year or FEV1 less than 60% of predicted without exacerbation in the past year. Control subjects were persons with no COPD or with mild COPD (FEV1 ≥60% predicted, no exacerbation in the past year). In random forests analyses, we identified the smallest set of questions plus peak expiratory flow (PEF) with optimal sensitivity (SN) and specificity (SP). MEASUREMENTS AND MAIN RESULTS: PEF and spirometry were recorded in 186 cases and 160 control subjects. The mean (SD) age of the sample population was 62.7 (10.1) years; 55% were female; 86% were white; and 16% had never smoked. The mean FEV1 percent predicted for cases was 42.5% (14.2%); for control subjects, it was 82.5% (15.7%). A five-item questionnaire, CAPTURE (COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk), was used to assess exposure, breathing problems, tiring easily, and acute respiratory illnesses. CAPTURE exhibited an SN of 95.7% and an SP of 44.4% for differentiating cases from all control subjects, and an SN of 95.7% and an SP of 67.8% for differentiating cases from no-COPD control subjects. The PEF (males, <350 L/min; females, <250 L/min) SN and SP were 88.0% and 77.5%, respectively, for differentiating cases from all control subjects, and they were 88.0% and 90.8%, respectively, for distinguishing cases from no-COPD control subjects. The CAPTURE plus PEF exhibited improved SN and SP for all cases versus all control subjects (89.7% and 78.1%, respectively) and for all cases versus no-COPD control subjects (89.7% and 93.1%, respectively). CONCLUSIONS: CAPTURE with PEF can identify patients with COPD who would benefit from currently available therapy and require further diagnostic evaluation. Clinical trial registered with clinicaltrials.gov (NCT01880177).

Adverse impacts of chronic pain on health-related quality of life, work productivity, depression and anxiety in a community-based study.

Background: Chronic pain has major clinical and social consequences. Few studies have examined any variation in the extent of impairment on quality of life and work productivity by site and type of chronic pain. Objective: The objective of our study is to examine adverse impacts of chronic pain on physical and psychological health and work productivity. Methods: Our community-population study was based on a phone-interview of adults with chronic pain, residing in Olmsted County, MN. Chronic pain groups were categorized into abdominal pain, back pain, joint pain, multisite pain, neuropathic pain or no chronic pain. We used standardized instruments, including the Brief Pain Inventory, the Patients Health Questionnair-9, and Work Productivity and Activity Impairment Questionnaire. Results: We evaluated 591 patients suffering from chronic pain and 150 participants with no chronic pain. Almost one third of patients with multisite pain (33%) and neuropathic pain (32%) reported mild/major depressive symptoms. Patients suffering from chronic pain, particularly from multisite pain and neuropathic pain, reported significant pain interferences with daily activities and impairments in physical function. Chronic pain was significantly associated with reduced performance at work but not with missed work hours. The average reported reduction in work productivity ranged from 2.4 hours (±5.6) per week for adults with joint chronic pain to 9.8 hours (±11.1) per week for adults with multisite chronic pain. Conclusions: Chronic pain, particularly multisite pain and neuropathic pain, significantly affected physical and psychological health. Chronic pain is a multifaceted health condition that requires a multidisciplinary treatment approach.

Developing a standardized healthcare cost data warehouse.

BACKGROUND: Research addressing value in healthcare requires a measure of cost. While there are many sources and types of cost data, each has strengths and weaknesses. Many researchers appear to create study-specific cost datasets, but the explanations of their costing methodologies are not always clear, causing their results to be difficult to interpret. Our solution, described in this paper, was to use widely accepted costing methodologies to create a service-level, standardized healthcare cost data warehouse from an institutional perspective that includes all professional and hospital-billed services for our patients. METHODS: The warehouse is based on a National Institutes of Research-funded research infrastructure containing the linked health records and medical care administrative data of two healthcare providers and their affiliated hospitals. Since all patients are identified in the data warehouse, their costs can be linked to other systems and databases, such as electronic health records, tumor registries, and disease or treatment registries. RESULTS: We describe the two institutions' administrative source data; the reference files, which include Medicare fee schedules and cost reports; the process of creating standardized costs; and the warehouse structure. The costing algorithm can create inflation-adjusted standardized costs at the service line level for defined study cohorts on request. CONCLUSION: The resulting standardized costs contained in the data warehouse can be used to create detailed, bottom-up analyses of professional and facility costs of procedures, medical conditions, and patient care cycles without revealing business-sensitive information. After its creation, a standardized cost data warehouse is relatively easy to maintain and can be expanded to include data from other providers. Individual investigators who may not have sufficient knowledge about administrative data do not have to try to create their own standardized costs on a project-by-project basis because our data warehouse generates standardized costs for defined cohorts upon request.