Baseline asthma burden, comorbidities, and biomarkers in omalizumab-treated patients in PROSPERO.

BACKGROUND: Patients included in clinical trials do not necessarily reflect the real-world population. OBJECTIVE: To understand the characteristics, including disease and comorbidity burden, of patients with asthma receiving omalizumab in a real-world setting. METHODS: The Prospective Observational Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab (PROSPERO) was a US-based, multicenter, single-arm, and prospective study. Patients (≥12 years of age) with allergic asthma initiating omalizumab treatment based on physician-assessed need were included and followed for 12 months. Exacerbations, health care use, adverse events, and Asthma Control Test (ACT) scores were assessed monthly. Biomarkers (blood eosinophils, fractional exhaled nitric oxide, and periostin) were evaluated and patient-reported outcomes (Asthma Quality of Life Questionnaire for 12 Years and Older [AQLQ+12] and Work Productivity and Activity Impairment: Asthma questionnaire [WPAI:Asthma]) were completed at baseline and months 6 and 12. The Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) was completed at baseline and 12 months. RESULTS: Most of the 806 enrollees (91.4%) were adults (mean age 47.3 years, SD 17.4), white (70.3%), and female (63.5%). Allergic comorbidity was frequently reported (84.2%), as were hypertension (35.5%) and depression (22.1%). In the 12 months before study entry, 22.1% of patients reported at least 1 asthma-related hospitalization, 60.7% reported at least 2 exacerbations, and 83.3% reported ACT scores no higher than 19 (uncontrolled asthma). Most patients had low biomarker levels based on prespecified cut-points. Baseline mean patient-reported outcome scores were 4.0 (SD 1.4) for AQLQ+12, 2.7 (SD 1.4) for MiniRQLQ, and 47.7 (SD 28.9) for WPAI:Asthma percentage of activity impairment and 33.5 (SD 28.7) for percentage of overall work impairment. CONCLUSION: The population initiating omalizumab in PROSPERO reported poorly controlled asthma and a substantial disease burden. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01922037.

Timing and duration of omalizumab response in patients with chronic idiopathic/spontaneous urticaria.

BACKGROUND: Few data are available that describe response patterns in patients with chronic idiopathic urticaria (CIU)/chronic spontaneous urticaria (CSU) treated with omalizumab. OBJECTIVE: We sought to describe response patterns by using data from the 3 pivotal omalizumab CIU/CSU trials. METHODS: Every 4 weeks, randomized patients received dosing with placebo or 75, 150, or 300 mg of omalizumab (ASTERIA I: n = 318, 24 weeks; ASTERIA II: n = 322, 12 weeks) or placebo or 300 mg of omalizumab (GLACIAL: n = 335, 24 weeks). Response was defined as well-controlled urticaria (weekly Urticaria Activity Score [UAS7] ≤ 6) or complete response (UAS7 = 0). RESULTS: Response rates were dose dependent and highest with 300 mg of omalizumab. Some patients responded early (before week 4). At week 12, a higher proportion of patients treated with 300 mg of omalizumab reported a UAS7 ≤ 6 (26.0% [75 mg of omalizumab], 40.0% [150 mg of omalizumab], 51.9% [300 mg of omalizumab], and 11.3% [placebo] for ASTERIA I; 26.8% [75 mg of omalizumab], 42.7% [150 mg of omalizumab], 65.8% [300 mg of omalizumab], and 19.0% [placebo] for ASTERIA II; and 52.4% [300 mg of omalizumab] and 12.0% [placebo] for GLACIAL) or a UAS7 = 0 (11.7% [75 mg of omalizumab], 15.0% [150 mg of omalizumab], 35.8% [300 mg of omalizumab], and 8.8% [placebo] for ASTERIA I; 15.9% [75 mg of omalizumab], 22.0% [150 mg of omalizumab], 44.3% [300 mg of omalizumab], and 5.1% [placebo] for ASTERIA II; and 33.7% [300 mg of omalizumab] and 4.8% [placebo] for GLACIAL). In patients receiving 300 mg of omalizumab with 24 weeks of treatment, median time to achieve a UAS7 ≤ 6 was 6 weeks (ASTERIA I and GLACIAL) and median time to achieve a UAS7 = 0 was 12 or 13 weeks (ASTERIA I and GLACIAL, respectively). Some patients who achieved well-controlled urticaria or complete response sustained response throughout the treatment period. CONCLUSION: Benefits of omalizumab treatment were evident early (before week 4) in some patients and persisted to week 24. Use of 300 mg of omalizumab demonstrated best results in controlling CIU/CSU symptoms.

Angioedema in the omalizumab chronic idiopathic/spontaneous urticaria pivotal studies.

BACKGROUND: Angioedema, present in some patients with chronic idiopathic/spontaneous urticaria (CIU/CSU), may have a negative effect on patient quality of life. OBJECTIVE: To describe patient-reported angioedema and its management in the pivotal omalizumab studies (ASTERIA I, ASTERIA II, GLACIAL). METHODS: Enrolled patients with CIU/CSU remained symptomatic despite treatment with histamine1 (H1)-antihistamines at licensed doses (ASTERIA I, ASTERIA II) or H1-antihistamines at up to 4 times the approved dose plus H2-antihistamines and/or a leukotriene receptor antagonist (GLACIAL). All studies administered omalizumab (75, 150, or 300 mg in ASTERIA I and ASTERIA II; 300 mg in GLACIAL) or placebo subcutaneously every 4 weeks for at least 12 weeks. Urticaria Patient Daily Diary entries were completed by patients and summarized. RESULTS: At baseline, angioedema prevalence was higher in GLACIAL (53.1%) than in ASTERIA I (47.5%) or ASTERIA II (40.7%). The mean proportion of angioedema-free days during weeks 4 to 12 was greater for patients treated with 300 mg of omalizumab than placebo in ASTERIA I (96.1% vs 88.2%, P < .001), ASTERIA II (95.5% vs 89.2%, P < .001), and GLACIAL (91.0% vs 88.7%, P = .006). Most patient-reported angioedema was managed by low-intensity interventions (doing nothing or taking medication). CONCLUSION: Treatment with 300 mg of omalizumab was efficacious in reducing patient-reported angioedema. Low-intensity interventions were generally used to manage angioedema episodes. TRIAL REGISTRATION: clinicaltrials.gov Identifiers: NCT01287117 (ASTERIA I), NCT01292473 (ASTERIA II), and NCT01264939 (GLACIAL).

Corticosteroid-related toxicity in patients with chronic idiopathic urticariachronic spontaneous urticaria.

BACKGROUND: Treatments for patients with chronic idiopathic urticaria (CIU)chronic spontaneous urticaria (CSU) who were unresponsive to antihistamines include oral corticosteroids (OCS). Risks of OCS-related side effects in these patients have not been described quantitatively. OBJECTIVE: To investigate the relationship between OCS use and the risk of developing side effects possibly attributable to OCS and associated health care costs in privately insured patients with CIU/CSU. METHODS: This retrospective cohort study analyzed a commercial claims data base from January 1, 2008, to December 31, 2012. Patients with CIU/CSU were identified by International Classification of Diseases, Ninth Revision, Clinical Modification codes via a validated algorithm. Possible OCS-related side effects included the following: diabetes mellitus, hypertension, lipid disorders, cataracts, depression or mania, osteoporosis or fractures, and infectious diseases. A time-dependent Cox regression (adjusted for age, sex, Charlson Comorbidity Index, and immunomodulator use) was used to separately model cumulative oral prednisone-equivalent exposure and the risk of side effects. Incremental total adjusted health care costs were compared in patients with versus patients without possible OCS-related side effects. RESULTS: Among 12,647 patients with CIU/CSU, 55.4% used OCS. An additional 1 g of prednisone-equivalent exposure was associated with a 7% increase in the likelihood of developing a possible side effect (hazard ratio, 1.07 [95% confidence interval, 1.051.08]). From the period before to the period after OCS initiation, the total mean adjusted annual health care costs increased by 1833 in users of OCS with new possible side effects and decreased by 2183 in patients without new possible side effects (p 0.001). CONCLUSION: Patients with CIU/CSU who were treated with OCS had an increased risk of possible OCS-related side effects and higher total health care costs than their counterparts not treated with OCS.

Can bundled payment improve quality and efficiency of care for patients with hip fractures?

The current Medicare reimbursement for hip fractures lacks accountability and promotes cost cutting. A bundled payment system-analogous to the Medicare Acute Care Episodes Demonstration for Orthopedic and Cardiovascular Surgery-may help curtail costs, foster communication among health care providers, and improve their accountability for patient outcomes. In hip fracture care, bundled payment may spur development of multidisciplinary best practice guidelines, quality assessment, and reporting, and result in benchmarking and best practices sharing. However, its implementation may face challenges: the need for quality assessment criteria and risk adjustment methods and possible risks of pushing costs outside of Medicare boundaries.

Tibia shaft fractures: costly burden of nonunions.

BACKGROUND: Tibia shaft fractures (TSF) are common for men and women and cause substantial morbidity, healthcare use, and costs. The impact of nonunions on healthcare use and costs is poorly described. Our goal was to investigate patient characteristics and healthcare use and costs associated with TSF in patients with and without nonunion. METHODS: We retrospectively analyzed medical claims in large U.S. managed care claims databases (Thomson Reuters MarketScan®, 16 million lives). We studied patients ≥ 18 years old with a TSF diagnosis (ICD-9 codes: 823.20, 823.22, 823.30, 823.32) in 2006 with continuous pharmaceutical and medical benefit enrollment 1 year prior and 2 years post-fracture. Nonunion was defined by ICD-9 code 733.82 (after the TSF date). RESULTS: Among the 853 patients with TSF, 99 (12%) had nonunion. Patients with nonunion had more comorbidities (30 vs. 21, pre-fracture) and were more likely to have their TSF open (87% vs. 70%) than those without nonunion. Patients with nonunion were more likely to have additional fractures during the 2-year follow-up (of lower limb [88.9% vs. 69.5%, P < 0.001], spine or trunk [16.2% vs. 7.2%, P = 0.002], and skull [5.1% vs. 1.3%, P = 0.008]) than those without nonunion. Nonunion patients were more likely to use various types of surgical care, inpatient care (tibia and non-tibia related: 65% vs. 40%, P < 0.001) and outpatient physical therapy (tibia-related: 60% vs. 42%, P < 0.001) than those without nonunion. All categories of care (except emergency room costs) were more expensive in nonunion patients than in those without nonunion: median total care cost $25,556 vs. $11,686, P < 0.001. Nonunion patients were much more likely to be prescribed pain medications (99% vs. 92%, P = 0.009), especially strong opioids (90% vs. 76.4%, P = 0.002) and had longer length of opioid therapy (5.4 months vs. 2.8 months, P < 0.001) than patients without nonunion. Tibia fracture patterns in men differed from those in women. CONCLUSIONS: Nonunions in TSF's are associated with substantial healthcare resource use, common use of strong opioids, and high per-patient costs. Open fractures are associated with higher likelihood of nonunion than closed ones. Effective screening of nonunion risk may decrease this morbidity and subsequent healthcare resource use and costs.

Burden of paediatric influenza in Western Europe: a systematic review.

BACKGROUND: Influenza illness in children causes significant clinical and economic burden. Although some European countries have adopted influenza immunisation policies for healthy children, the debate about paediatric influenza vaccination in most countries of the European Union is ongoing. Our aim was to summarise influenza burden (in terms of health outcomes and economic burden) in children in Western Europe via a systematic literature review. METHODS: We conducted a systematic literature search of PubMed, EMBASE, and the Cochrane Library (1970-April 2011) and extracted data on influenza burden in children (defined as aged ≤ 18 years) from 50 publications (13 reporting laboratory-confirmed influenza; 37 reporting influenza-like illness). RESULTS: Children with laboratory-confirmed influenza experienced hospitalisations (0.3%-20%), medical visits (1.7-2.8 visits per case), antibiotic prescriptions (7%-55%), and antipyretic or other medications for symptomatic relief (76%-99%); young children and those with severe illness had the highest rates of health care use. Influenza in children also led to absenteeism from day care, school, or work for the children, their siblings, and their parents. Average (mean or median) length of absence from school or day care associated with confirmed influenza ranged from 2.8 to 12.0 days for the children, from 1.3 to 6.0 days for their siblings, and from 1.3 to 6.3 days for their parents. Influenza negatively affected health-related quality of life in children with asthma, including symptoms and activities; this negative effect was smaller in vaccinated children than in non-vaccinated children. CONCLUSIONS: Influenza burden in children is substantial and has a significant direct impact on the ill children and an indirect impact on their siblings and parents. The identified evidence regarding the burden of influenza may help inform both influenza antiviral use in children and paediatric immunisation policies in European countries.

Older people presenting to the emergency department after a fall: a population with substantial recurrent healthcare use.

OBJECTIVES: To document patient characteristics, care pathways, healthcare use and costs of fall-related emergency department (ED) presentations by older adults. PARTICIPANTS AND METHODS: All fallers aged ≥70 years, presenting to the ED of a 450-bed metropolitan university hospital in Sydney, Australia (1 April 2007 through 31 March 2009) were studied. Data were collected from the ED electronic information system, ED clinical records and the hospital electronic information system database. Population estimates for 2008 for the local areas served by the hospital were used to estimate ED presentation rates. RESULTS: Of 18 902 all-cause ED presentations, 3220 (17.0%) were due to a fall. Among fallers, 35.4% had one or more ED presentations and 20.3% had had one or more hospital admissions in the preceding 12 months. Fall-related ED presentation led directly to hospital admission in 42.7% of the cases, the majority of which (78.0%) received acute care only (length of stay-14.4 days for men and 13.7 days for women) and the remaining cases underwent further inpatient rehabilitation (length of stay 35.6 days for men and 30.1 days for women). After hospitalisation, 9.5% of patients became first-time residents of long-term care facilities. All fall-related ED presentations and hospitalisations cost a total of A$11 241 387 over the study period. CONCLUSIONS: Older fallers presenting to the ED consume significant healthcare resources and are an easily identifiable high-risk population. They may benefit from systematic fall-risk assessment and tailored fall-prevention interventions.

Patient Outcomes, Health Care Resource Use, and Costs Associated with High Versus Low HEDIS Asthma Medication Ratio.

BACKGROUND: The Healthcare Effectiveness Data and Information Set (HEDIS) quality measures for asthma include the asthma medication ratio (AMR) as a marker of quality of care for patients with asthma. Few data are available to describe the association between health care use and costs in patients with high versus low AMR. OBJECTIVE: To characterize health care use and costs associated with high versus low AMR in patients participating in commercial health plans. METHODS: In a commercial claims database, this study retrospectively identified patients aged 5 to 64 years on December 31, 2011, who met the HEDIS definition of asthma in the premeasurement year (January 1, 2010-December 31, 2010) and the measurement year (January 1, 2011-December 31, 2011). Each patient was classified as having either high or low AMR based on the HEDIS definition. AMR was calculated as the ratio of controller to total asthma medications; high AMR was defined as ≥ 0.5. Annual per-patient health care use and costs were compared in patients with high versus low AMR using (a) multivariable linear regression models to estimate mean annual number of office visits, oral corticosteroids (OCS) bursts (≤ 15-day supply), and costs and (b) negative binomial models to estimate mean annual hospitalization and emergency department (ED) visits. All estimates were adjusted for age, sex, region, and Charlson Comorbidity Index score to control for differences between patients with high versus low AMR. RESULTS: Patients were identified with high (30,575) and low (6,479) AMR. An average patient with high AMR had more all-cause office visits (14.1 vs. 11.0; P < 0.001), fewer all-cause hospitalizations (0.109 vs. 0.215; P < 0.001), fewer all-cause ED visits (0.321 vs. 0.768; P < 0.001), and fewer OCS bursts (0.83 vs. 1.33; P < 0.001) than an average patient with low AMR. An average patient with high AMR had fewer asthma-related hospitalizations (0.024 vs. 0.088; P < 0.001) and ED visits (0.060 vs. 0.304; P < 0.001) than an average patient with low AMR. Numbers of asthma-related annual office visits were similar between the high and low AMR groups (high 2.2 vs. low 2.2; not significant). The rate of poor asthma control events (≥ 6 short-acting beta-agonist dispensing events or ≥ 2 OCS bursts, asthma-related ED visits, or hospitalizations) was greater in patients with low AMR than in patients with high AMR (74.3% vs. 26.9%). An average patient with high AMR had lower annual nonmedication costs than an average patient with low AMR ($5,733 vs. $6,295; P = 0.011). Similar trends emerged for asthma-related costs. A patient with high AMR had higher average total annual health care costs than a patient with low AMR ($9,811 vs. $8,398; P < 0.001). These increased costs primarily resulted from increased medication costs for patients with high versus low AMR ($4,077 vs. $2,103; P < 0.001). CONCLUSIONS: Although patients with high AMR had more office visits and higher medication (which resulted in higher overall health care) costs, their care was marked by fewer OCS bursts (indicating fewer instances of poor asthma control), fewer ED visits, and fewer hospitalizations and lower non-medication costs than those patients with low AMR. These findings support the use of AMR as a care quality measure for patients with persistent asthma. DISCLOSURES: This study was funded by Genentech. Luskin has received consulting and lecture fees, research and travel support, and payment for developing educational presentations from Genentech and has received lecture fees from Merck. Raimundo and Solari are employees of Genentech. Antonova was employed by Genentech at the time of this study. Broder and Chang are employees of Partnership for Health Analytic Research, which received funding from Genentech to conduct this research. Study concept and design were contributed by all authors. Broder and Chang conducted analyses. All authors interpreted the data. Antonova wrote the manuscript with assistance from the other authors. All authors participated in manuscript review and revisions.

Health care resource use and costs associated with possible side effects of high oral corticosteroid use in asthma: a claims-based analysis.

BACKGROUND: The objective of this study was to estimate the prevalence of possible oral corticosteroid (OCS)-related side effects and health care resource use and costs in patients with asthma. METHODS: This was a cross-sectional, matched-cohort, retrospective study using a commercial claims database. Adults with asthma diagnosis codes and evidence of asthma medication use were studied. Patients with high OCS use (≥30 days of OCS annually) were divided into those who did versus those who did not experience OCS-related possible side effects. Their health care resource use and costs were compared using linear regression or negative binomial regression models, adjusting for age, sex, geographic region, Charlson Comorbidity Index score, and chronic obstructive pulmonary disease status. RESULTS: After adjustment, high OCS users with possible side effects were more likely to have office visits (23.0 vs 19.6; P<0.001) and hospitalizations (0.44 vs 0.22; P<0.001) than those without possible side effects. Emergency department visits were similar between the groups. High OCS users with possible side effects had higher adjusted total annual mean health care costs ($25,168) than those without such side effects ($21,882; P=0.009). CONCLUSION: Among high OCS users, patients with possible OCS-related side effects are more likely to use health care services than those without such side effects. Although OCS may help control asthma and manage exacerbations, OCS side effects may result in additional health care resource use and costs, highlighting the need for OCS-sparing asthma therapies.

Improvement of sleep in patients with chronic idiopathic/spontaneous urticaria treated with omalizumab: results of three randomized, double-blind, placebo-controlled studies.

BACKGROUND: Patients with chronic idiopathic/spontaneous urticaria (CIU/CSU) report difficulty with sleep. METHODS: We examined the effect of omalizumab on sleep-related outcomes during 3-6 months omalizumab or placebo treatment and a 16-week follow-up period within three Phase III double-blind randomized placebo-controlled pivotal trials in CIU/CSU: ASTERIA I, ASTERIA II, and GLACIAL. Sleep quality was assessed in all three studies using sleep-related questions included in an electronic diary, the Chronic Urticaria Quality of Life Questionnaire, and the Medical Outcomes Study Sleep Scale. Score changes from baseline in the treatment arms were compared with that in the placebo arm and adjusted for baseline score and weight. We also examined correlations of sleep scores at baseline, week 12, and week 24 and the slopes of change between sleep and itch and hive. RESULTS: Patients treated with omalizumab reported a larger reduction in sleep problems than those in the placebo arm; omalizumab 300 mg demonstrated the greatest improvement on all sleep components among all treatment arms. The largest reduction in sleep problems was reported within the first 4 weeks of therapy. After treatment discontinuation, sleep quality worsened. Sleep scores demonstrated moderate-to-strong correlation between them, and the change in sleep scores was associated with changes in itch and hives. CONCLUSIONS: Improvement in sleep was reported after the first dose of omalizumab. Sleep continued to improve throughout the active treatment period. Patients receiving omalizumab 300 mg achieved greater improvement in sleep than those in other treatment arms. Trial registration ClinicalTrials.gov, NCT01287117 (ASTERIA I), NCT01292473 (ASTERIA II), and NCT01264939 (GLACIAL).

Resource use and costs in an insured population of patients with chronic idiopathic/spontaneous urticaria.

BACKGROUND: Chronic idiopathic or spontaneous urticaria (CIU/CSU) impairs patients' quality of life, and updated information on disease prevalence, treatment patterns, and disease burden is lacking. OBJECTIVES: We aimed to estimate these figures in a large US real-world claims database via a validated algorithm. METHODS: In this retrospective cross-sectional cohort study, we identified patients with CIU/CSU, estimated disease prevalence, comorbidities, and healthcare use (medications, office visits, emergency department visits, and hospitalizations) and costs (urticaria related and all cause). RESULTS: We identified 6350 CIU/CSU patients in a population of just over 5.8 million: 0.11 % prevalence. Women accounted for the majority of sufferers (68.3 %) and had a greater burden of illness than men. Patients had relatively few comorbidities (mean 3.3, standard deviation 2.2). Primary care physicians and allergists were the most common providers of CIU/CSU-related care. Oral corticosteroids were the most commonly prescribed medication, used in 54.7 % of patients. Patients accumulated a mean of 15.1 office visits per year (standard deviation 12.6). The mean all-cause healthcare cost totaled over US$9000 per year. CONCLUSIONS: Although the disease affects a relatively young population, CIU/CSU carries a substantial cost. Frequent oral corticosteroid use in CIU/CSU patients is a concern because of adverse events associated with the drug.

Seasonal influenza vaccination trends from 2007-2011 in privately insured children and adults in the United States.

BACKGROUND: To ensure adequate protection from seasonal influenza in the US, the Advisory Committee on Immunization Practices recommends vaccination of all persons aged 6 months or older, with rare exceptions. It also advises starting vaccination as soon as available and continuing throughout the influenza season. This study examined US seasonal vaccination trends during five consecutive influenza seasons in privately-insured children and adults. METHODS: This retrospective, observational cohort study examined trends in influenza vaccination during the 2007-2008 through 2011-2012 influenza seasons using administrative claims data from a large national insurer. RESULTS: The size of analysis population ranged from 1144,098 to 1245,487 (children, ≥6 months-17 years of age) and from 3931,622 to 4158,223 (adults, 18-64 years of age). Vaccination frequency increased through 2010-2011, was most frequent in young children, and decreased with age. Vaccination rates were highest in the Northeast and lowest in the West and were higher in individuals with frequent outpatient office visits than in those with no or rare visits, with larger differences seen in children. Between 2007 and 2011, the use of preservative-free inactivated vaccine increased, the use of multidose vaccines containing preservatives decreased, and the use of live attenuated influenza vaccines increased among children 2-17 years of age. From 2007-2008 through 2009-2010, the timing of vaccination each year began earlier than the previous one; it remained stable from 2009-2010 through 2011-2012. CONCLUSION: Annual influenza vaccination claims for privately-insured children and adults increased and shifted earlier from 2007 through 2009-2011. During the 2011-2012 influenza season, 25.4% of children aged 6 months-17 years and 12.3% of adults aged 18-64 years were vaccinated. Increasing influenza vaccination should remain a priority, and alternative venues for seasonal influenza vaccination should be considered in order to meet the Healthy People 2020 goal of 80% to 90% coverage among children.

Scope and severity index: a metric for quantifying nursing home survey deficiency number, scope, and severity adjusted for the state-related measurement bias.

OBJECTIVES: To develop a metric (scope and severity index [SSI]) to measure nursing home deficiency number, scope, and severity adjusted for the state-related bias and to test its convergent and predictive validity. DESIGN: We assigned scope and severity weights to each level of scope and severity (A-L). SSI was calculated as a sum of all weights per survey which was further corrected for the state-level bias by dividing by the state average number of health deficiencies and multiplying by the national average number of health deficiencies. Data source - National Online Survey, Certification, and Reporting system. SETTING: All Medicare/Medicaid-certified skilled nursing facilities. MEASUREMENTS: We correlated SSI with nursing home staffing levels (convergent validity) and denial of payment for new admissions (predictive validity). RESULTS: The expert panel reached agreement on the scope and severity weights: Level A = 5, B = 10, C = 15, D = 20, E = 30, F = 40, G = 35, H = 50, I = 65, J = 55, K = 75, and L = 100 points. Scope and severity per deficiency was positively correlated with the number of deficiencies in that survey. SSI contained almost no state-related bias, but yet related state-level variability. It demonstrated strong face, convergent, and predictive validity. CONCLUSIONS: SSI rendered a valuable metric to conduct quantitative analyses of nursing home deficiency number, scope, and severity across states. Future research should investigate the positive relationship between scope and severity of deficiencies and their number. Better understanding and correction of other factors introducing systematic bias to the survey results (e.g. regional impact) can further improve the accuracy of survey result evaluation.