Oral corticosteroid exposure and adverse effects in asthmatic patients.

BACKGROUND: Significant adverse effects (AEs) have been associated with continuous exposure to oral corticosteroids (OCSs). The potential association with intermittent exposure is unknown. OBJECTIVE: We sought to assess the association between OCSs and AEs based on the number of OCS prescriptions. METHODS: This was a retrospective cohort study of asthmatic patients 18 years and older in the 2000-2014 MarketScan data set. Propensity score matching was used at baseline (12 months before the index date: first OCS use). Logistic regression was used to examine the association between OCSs and new incident AEs (either combined or individual) controlling for covariates. Follow-up continued for 24 months minimum and 10 years maximum after the index date. RESULTS: There were 72,063 and 156,373 subjects in the OCS and no OCS cohorts, respectively. Subjects taking 4 or more OCS (1-3) prescriptions within the year had 1.29 (1.04) times the odds of experiencing a new AE within the year. Each year of exposure to 4 or more OCS prescriptions (current and past) resulted in 1.20 times the odds of having an AE in the current year. Exposure to 4 or more prescriptions was associated with significantly greater odds of AEs for osteoporosis, hypertension, obesity, type 2 diabetes, gastrointestinal ulcers/bleeds, fractures, and cataracts (odds, 1.21-1.44 depending on the AE). CONCLUSION: Although previous research has documented the deleterious effect of continuous OCS exposure in patients with severe asthma, our results suggest that each OCS prescription might result in a cumulative burden on current and future health regardless of dose and duration. OCS-sparing strategies are extremely important to improve patient outcomes.

Is the EQ-5D fit for purpose in asthma? Acceptability and content validity from the patient perspective.

BACKGROUND: The increasing emphasis on patient-reported outcomes in health care decision making has prompted greater rigor in the evidence to support the instruments used. Acceptability and content validity are important properties of any measure to ensure it assesses the relevant aspects of the target concept. The purpose of this study was to evaluate the acceptability and content validity of the EQ-5D 5-Level (EQ-5D-5L) to assess the impact of asthma on patients' lives. METHODS: Qualitative interviews were conducted with 40 adults with asthma in the United Kingdom. The first 25 interviews used cognitive-debriefing methods to assess the relevance and acceptability of the EQ-5D-5L and two asthma-specific measures for comparison: an asthma-specific, preference-based measure (the Asthma Quality of Life Utility Index-5 Dimensions) and an Asthma Symptom Diary. The final 15 interviews combined concept elicitation to identify patient-perceived asthma impact, and cognitive debriefing to assess relevance and acceptability of the EQ-5D-5L and the Asthma Symptom Diary. Cognitive-debriefing feedback on the content of the measures was collated and summarized descriptively. The concept-elicitation data were analyzed thematically. RESULTS: Participants were aged 20 to 57 years and 62.5% were female. Although some participants expressed positive opinions on aspects of the EQ-5D-5L, only the usual activities dimension was consistently considered relevant to participants' asthma experiences. The mobility and self-care dimensions prompted strong negative reactions from some participants. Variations in interpretation of the mobility dimension and difficulties with multiple concepts in the pain/discomfort and anxiety/depression dimensions also were noted. Concepts reported by participants as missing included environmental triggers, asthma symptoms, emotions, and sleep. The EQ-5D-5L was the least preferred measure to describe the impact of asthma on participants' lives. Participants reported shortness of breath and impact on activities as especially salient issues. CONCLUSIONS: The content of the EQ-5D-5L was poorly aligned with the patient-perceived impact of asthma, and the measure failed to meet basic standards for acceptability and content validity as a measure to assess the impact of asthma from the patient perspective. The shortcomings identified raise concerns regarding the appropriateness of the EQ-5D in asthma and further evaluation is warranted.

Estimating asthma control questionnaire (ACQ) scores from claims data.

BACKGROUND: Asthma control is the main focus of treatment guidelines. Valid instruments such as the Asthma Control Questionnaire (ACQ) require prospective survey. These surveys may be challenging for large population health applications. OBJECTIVE: To develop an algorithm for estimating ACQ-5 scores from commonly available claims data. METHODS: Data was derived from four prospective surveys including the ACQ-5 combined with retrospective claims of Kaiser Permanente of Colorado (KPCO) patients. The statistical approach consisted of derivation and validation of a prediction algorithm including medical and pharmacy claims data using stepwise regression elimination. Validation was conducted by estimating mean squared error (MSE) and mean absolute error (MAE) in one hundred split-sample iterations. Ordinary least squares (OLS), Tobit and Median regression were used. RESULTS: There were 2,657 individuals with valid ACQ-5 scores, claims and eligibility at baseline. The following had statistically significant associations with ACQ-5 scores: gender, use of oral corticosteroids and short-acting beta agonists, the number of asthma drug classes, and emergency and outpatient visits. Average MSE and MAE were similar for the estimation and validation samples. CONCLUSION: This research provides preliminary results of the feasibility of predicting ACQ-5 scores using commonly available medical and pharmacy claims data. The resulting algorithm may facilitate public health and population level analyses of asthma control. Future studies in different populations will be important to validate the algorithm.

Measuring the cost of poor asthma control and exacerbations.

BACKGROUND: Previous studies have shown an association between cost and poor asthma control. However, longitudinal studies of general populations are lacking. OBJECTIVE: To examine the cost of poor asthma control and exacerbations across a broad spectrum of asthma patients. METHODS: The Observational Study of Asthma Control and Outcomes (OSACO) was a prospective survey of persistent asthma patients in Kaiser Colorado in 2011-2012. Patients received a survey 3 times in one year, which included the Asthma Control Questionnaire (ACQ) and questions on exacerbations. Self-reported exacerbations were compared to actual oral corticosteroid (OCS) use. Regression analyses examined the association of control (ACQ-5 scores) and exacerbations with healthcare expenditures, controlling for sociodemographics and smoking. Analyses of expenditures used Generalized Linear Models (GLM) with log-link. RESULTS: 2681 individuals completed at least one survey; 1799 completed all three. ACQ-5 scores were associated with higher all-cause and asthma-specific expenditures across all categories of costs (medical, outpatient, ER, pharmacy) except for inpatient expenditures. Each 1-point increase in the ACQ-5 score (i.e., worse control) was associated with a corresponding increase in all-cause annual healthcare and asthma-specific expenditures of $1443 and $927 ($US 2013). Asthma exacerbations with documented OCS use were associated with an increase of $3014 and $1626 over 4 months, while self-reported exacerbations were $713 and $506. CONCLUSION: Results demonstrate that poor asthma control and exacerbations are strongly associated with higher healthcare expenditures. Results also confirm that collection of validated measures of control such as the ACQ-5 may provide valuable information toward improving clinical and economic outcomes.

Health-related quality of life associated with systemic corticosteroids.

BACKGROUND: Systemic corticosteroids (SCS) are commonly used but are associated with adverse effects. Given their prevalent use, the potential impact of SCS use on health-related quality of life (HRQoL) is important to characterize. OBJECTIVE: To assess the HRQoL of patients taking SCS. METHODS: The 2000-2003 Medical Expenditure Panel Survey was used to examine EQ-5D and SF-6D scores associated with SCS use in adults. The study sample was restricted to those with a condition for which SCS are prescribed. SCS use was categorized into three levels: none; 1-3; and ≥4 prescriptions per year. HRQoL scores were regressed on SCS use (1-3 or ≥4 annual prescriptions) controlling for age, gender, race, ethnicity, education, income category, geographic region, number of ER visits, number of outpatient visits, total number of chronic conditions (for which SCS are not used) and conditions for which SCS are clinically indicated. RESULTS: There were 54,856 individuals with no SCS exposure, 2245 with 1-3 and 624 with ≥4 annual SCS prescriptions. In adjusted analyses, use of ≥4 annual SCS prescriptions appeared to be associated with significantly lower EQ-5D (US), EQ-5D (UK), SF-6D and EQ-5D VAS scores compared to no exposure: -0.032, -0.047, -0.036, and -7.58. CONCLUSION: While SCS are efficacious and widely used for numerous conditions, results suggest that their use may be associated with a substantial deleterious impact on HRQoL. This potential negative effect should be considered in balance with the cost and efficacy of comparable treatments.

Exploring asthma control cutoffs and economic outcomes using the Asthma Control Questionnaire.

BACKGROUND: Understanding the effect of worsening asthma control on expenditures and health resource utilization (HRU) is important. OBJECTIVE: To explore the association of economic outcomes with asthma control cutoffs and longitudinal changes on the Asthma Control Questionnaire 5 (ACQ-5). METHODS: The Observational Study of Asthma Control and Outcomes was a survey of patients with persistent asthma who were patients of Kaiser Colorado, including claims-based HRU. Patients completed the ACQ-5 three times during 1 year between April 2011 and June 2012. The ACQ-5 cutoffs that indicated control were assessed in cross-sectional analyses. Longitudinal changes in control were explored: controlled (ACQ-5 score <0.75), indeterminate (ACQ-5 score 0.75 to <1.5), not well controlled (ACQ-5 score 1.5 to <3.0), and very poorly controlled (ACQ-5 score ≥3.0). Analyses used generalized linear models with log link (expenditures) and negative binomial regression (HRU). RESULTS: There were 6,666 completed surveys (1,799 individuals completed all 3 survey waves). In the cross-sectional analyses, compared with an ACQ-5 score less than 0.5, individuals with ACQ-5 scores of 4 to 4.5 incurred 7.2 times the number of oral corticosteroid prescriptions, 4.3 times the number of emergency department visits, 6 times the number of inpatient visits, 10.4 times the number of asthma-specific emergency department visits, 4.58 times the number of asthma-specific inpatient visits, and $2,892 more in all-cause and $1,877 in asthma-specific expenditures during 4 months. In the longitudinal change analyses, individuals who improved from an ACQ-5 of 3.0 or greater to less than 0.75 incurred $6,023 less in asthma-specific expenditures during 4 months than those remaining at an ACQ-5 score of 3.0 or higher. CONCLUSION: Results provide preliminary economic data on possible control cutoffs for the ACQ-5. Improving asthma control over time may result in significant savings that may justify financial investments designed to improve control.

Development of the chronic obstructive pulmonary disease morning symptom diary (COPD-MSD).

BACKGROUND: The morning tends to be the most difficult time of day for many patients with chronic obstructive pulmonary disease (COPD) when symptoms can limit one's ability to perform even simple activities. Morning symptoms have been linked to higher levels of work absenteeism, thereby increasing the already substantial economic burden associated with COPD. A validated patient-reported outcome (PRO) instrument designed to capture morning symptoms will allow for a more comprehensive approach to the evaluation of treatment benefit in COPD clinical trials. METHODS: A qualitative interview study was conducted among a sample of symptomatic adults with COPD. Concept elicitation interviews (n = 35) were conducted to identify COPD morning symptoms, followed by cognitive interviews (n = 21) to ensure patient comprehension of the items, instructions and response options of the draft COPD Morning Symptom Diary (COPD-MSD). All interview transcript data were coded using ATLAS.ti software for content analysis. RESULTS: Mean age of the concept elicitation and cognitive interview sample was 65.0 years (±7.5) and 62.3 years (±8.3), respectively. The study sample represented the full range of COPD severity (Global Initiative for Chronic Lung Disease [GOLD] classifications I-IV) and included a mix of racial backgrounds, employment status and educational achievement. During the concept elicitation interviews, the three most frequently reported morning symptoms were shortness of breath (n = 35/35; 100 %), phlegm/mucus (n = 31/35; 88.6 %), and cough (n = 30/35; 85.7 %). A group of clinical and instrument development experts convened to review the concept elicitation data and develop the initial 32-item draft COPD-MSD. Cognitive interviews indicated subjects found the draft COPD-MSD to be comprehensive, clear, and easy to understand. The COPD-MSD underwent minor editorial revisions and streamlining based on cognitive interviews and input from the experts to yield the final 19-item daily diary. CONCLUSIONS: This study supports the content validity of the new COPD-MSD and positions the diary for quantitative psychometric testing.

Measurement of utility in asthma: evidence indicating that generic instruments may miss clinically important changes.

BACKGROUND: Accurate assessment of preference-based health-related quality of life is important in determining the value of asthma interventions. OBJECTIVE: To examine the sensitivity and responsiveness of the EQ-5D and the AQL-5D to differences in asthma control measured by the Asthma Control Questionnaire (ACQ-5). METHODS: The Observational Study of Asthma Control and Outcomes was a prospective survey of persistent asthma patients ≥12 years old in Kaiser Colorado. Patients received a survey three times in 1 year, including the ACQ-5, AQL-5D and EQ-5D-3L (including VAS). Censored Least Absolute Deviations (CLAD) and logistic regression were used, controlling for sociodemographics and smoking. RESULTS: There were 6666 completed surveys (1799 individuals completed all three survey waves). After controlling for covariates, each one-point increase in ACQ-5 was associated with a decrease of 0.066, 0.058, 0.074 and 6.12 in EQ-5D(US), EQ-5D(UK), AQL-5D and VAS scores. Uncontrolled asthma (ACQ-5 > 1.5) was associated with a decrease of 0.15, 0.17, 0.11 and 10, respectively (vs. ACQ ≤ 1.5). AQL-5D scores were statistically significantly different across categories of ACQ-5 scores of 0.5 (the minimum clinically important difference [MCID]), while EQ-5D scores were not significant across most categories. The AQL-5D appeared more robust to changes in control over time (responsiveness) compared to EQ-5D-3L. CONCLUSION: The AQL-5D appears more responsive to changes in asthma control over time and more sensitive to detecting differences corresponding to the ACQ-5 MCID than the EQ-5D-3L. Using the EQ-5D-3L without an asthma-specific measure such as the AQL-5D may miss clinically important changes in asthma control.

Clinical Practice Guideline: Chiropractic Care for Low Back Pain.

OBJECTIVE: The purpose of this article is to provide an update of a previously published evidence-based practice guideline on chiropractic management of low back pain. METHODS: This project updated and combined 3 previous guidelines. A systematic review of articles published between October 2009 through February 2014 was conducted to update the literature published since the previous Council on Chiropractic Guidelines and Practice Parameters (CCGPP) guideline was developed. Articles with new relevant information were summarized and provided to the Delphi panel as background information along with the previous CCGPP guidelines. Delphi panelists who served on previous consensus projects and represented a broad sampling of jurisdictions and practice experience related to low back pain management were invited to participate. Thirty-seven panelists participated; 33 were doctors of chiropractic (DCs). In addition, public comment was sought by posting the consensus statements on the CCGPP Web site. The RAND-UCLA methodology was used to reach formal consensus. RESULTS: Consensus was reached after 1 round of revisions, with an additional round conducted to reach consensus on the changes that resulted from the public comment period. Most recommendations made in the original guidelines were unchanged after going through the consensus process. CONCLUSIONS: The evidence supports that doctors of chiropractic are well suited to diagnose, treat, co-manage, and manage the treatment of patients with low back pain disorders.

Outcomes before and after treatment escalation to Global Initiative for Asthma steps 4 and 5 in severe asthma.

BACKGROUND: Little is known about health outcomes in severe asthma reflected by Global Initiative for Asthma steps 4 and 5. OBJECTIVE: To analyze control, risk, economic, and health resource use (HRU) outcomes associated with treatment escalation to Global Initiative for Asthma steps 4 and 5. METHODS: This was a before-vs-after retrospective cohort study of patients (12-75 years old) with asthma newly initiated to omalizumab, high-intensity corticosteroids (HICS; ≥1,000 µg/day of inhaled fluticasone equivalent or oral prednisone), or high-dose inhaled corticosteroid (HDICS; ≥500 to <1,000 µg/day of fluticasone equivalent) using 2002 to 2011 MarketScan data. Poisson regression was used to model HRU outcomes; Tobit regression was used to model medical expenditures. RESULTS: Of 19,227 patients, 856 initiated omalizumab, 6,926 initiated HICS, and 11,445 initiated HDICS. Use of ß-agonist increased for the HDICS and HICS cohorts and decreased for the omalizumab cohort; acute care visits and oral corticosteroid use decreased during follow-up for the HDICS and omalizumab cohorts. Annual health care expenditures, polypharmacy burden, and outpatient visits were high for all cohorts and increased in the follow-up year (baseline to follow-up; general health care expenditures: omalizumab $14,071 to $34,887, HICS $12,030 to $15,557, HDICS $7,570 to $9,826; annual number of asthma prescriptions: omalizumab 11.74 to 19.46, HICS 7.8 to 12.44, HDICS 5.17 to 9.69; outpatient visits: omalizumab 26.79 to 34.06, HICS 18.78 to 21.37, HDICS 15.06 to 16.64). CONCLUSION: Omalizumab use was associated with improvements in risk and control accompanied by large increases in expenditures per HRU. Patients on HDICS and HICS showed improvements in risk but worsening control and increased expenditures per HRU. Innovations in disease management and available treatment options are needed to more optimally achieve treatment goals.

Symptoms and markers of symptom severity in asthma--content validity of the asthma symptom diary.

BACKGROUND AND OBJECTIVES: The American Thoracic Society/European Respiratory Society (ATS/ERS) Task Force acknowledged the multi-faceted nature of asthma in its recent definition of asthma control as a summary term capturing symptoms, reliever use, frequency/severity of exacerbations, lung function, and future risk and the Global Initiative for Asthma (GINA) defines the clinical manifestations (well established markers of asthma severity) of asthma to include symptoms, sleep disturbances, limitations of daily activity, impairment of lung function, and use of rescue medications. The objectives of this qualitative work were to identify symptoms and markers of symptom severity relevant to patients with moderate to severe asthma and to evaluate the content validity of the asthma symptom diary (ASD). METHODS: A qualitative interview study was conducted using a purposive sample of symptomatic adult and adolescent (≥12 years) subjects with asthma. Concept elicitation (CE) interviews (n = 50) were conducted to identify core asthma symptoms and symptom-related clinical markers, followed by cognitive interviews (n = 24) to ensure patient comprehension of the items, instructions and response options. CE interviews were coded using ATLAS.ti for content analysis. RESULTS: The study sample had a diverse range of symptom severity, level of symptom control, sociodemographic and socioeconomic status. The most frequently reported symptoms in adults were chest tightness (n = 33/34; 97.1%), wheezing (n = 31; 91.2%), coughing (n = 30; 88.2%), and shortness of breath (n = 25; 73.5%); in adolescents they were wheezing (n = 14/16; 87.5%), coughing (n = 13; 81.3%), and chest tightness (n = 11; 68.8%). Adults identified chest tightness followed by shortness of breath as their most severe symptoms; while adolescents reported coughing and chest tightness as their most severe symptoms. Sleep awakenings and limitations in day-to-day activities were frequent symptom-related clinical markers. Day-to-day variability and differences between daytime and nighttime symptom experiences reported by subjects resulted in the need for the ASD to be administered twice daily. Cognitive interviews indicated that subjects found the revised ASD items clear and easy to understand. CONCLUSIONS: This study supports the content validity of the revised ASD, showing it to be consistent with patient experiences and ready for further psychometric testing.

Characterizing the severe asthma population in the United States: claims-based analysis of three treatment cohorts in the year prior to treatment escalation.

OBJECTIVES: Little is known about the disposition of severe patients prior to treatment escalation. To classify patients by treatment step using pharmacy data and describe their economic and healthcare utilization, insurance status, and sociodemographic characteristics in the year prior to escalation to Global Initiative for Asthma (GINA) steps 4 and 5. METHODS: This was a retrospective claims cohort study of asthma patients (age 12-75 years) newly initiated on "stable therapy" (three consecutive months of therapy) with omalizumab, high intensity corticosteroids (HICS; ≥1000 µg/d inhaled fluticasone equivalent or oral prednisone), or high-dose inhaled corticosteroid (HDICS; ≥500-<1000 µg/d fluticasone equivalent) from 2002 to 2011. Other asthma treatments were compared as a reference. RESULTS: Of 25,297 patients, 856 initiated omalizumab, 6926 initiated HICS, and 11,445 initiated HDICS. In the year prior to treatment escalation to omalizumab, HICS, and HDICS, respectively, individuals had high annual mean medical expenditures ($14,071, $12,030, and $7570), utilization (27 outpatient and 10 specialty care visits; 19 outpatient and three specialty; 15 outpatient and two specialty), asthma-related prescription drugs (11.74, 7.8, and 5.17) and chronic comorbidities (2.68, 2.67, and 2.19). Prior to omalizumab treatment, patients were more likely to be salaried, full-time employees with commercial PPO/POS insurance. CONCLUSIONS: Prior to escalating treatment to GINA steps 4 and 5, individuals experienced significant annual medical expenditures, healthcare resource utilization and polypharmacy burden, which may reflect poorly controlled asthma and the need to escalate treatment. Medical claims data and utilization-based measures may be helpful in classifying individuals by GINA treatment step.

Asthma control in the United States, 2008-2010: indicators of poor asthma control.

BACKGROUND: An estimated 23 million Americans have asthma, of whom at least 12 million experience an asthma exacerbation every year. Clinical practice guidelines focus on asthma control, with an emphasis on reducing both impairment and risk. OBJECTIVE: We sought to explore broad patterns of asthma prevalence, self-reported medication use, and indicators of control in a nationally representative sample. METHODS: The 2008, 2009, and 2010 Medical Expenditure Panel Surveys were used to examine the national prevalence of self-reported asthma, trends in medication use, and demographic characteristics of asthmatic patients. History of lifetime asthma and current diagnosis were ascertained based on self-report. Asthma management and control were examined by using patient-reported medication use. RESULTS: Of the 102,544 subjects asked about an asthma diagnosis, 9,782 reported lifetime asthma, and 8,837 reported current asthma. Five thousand five subjects (4.8% of the population) reported experiencing an asthma exacerbation in the previous year. Four thousand five hundred twenty-one subjects used a quick-relief inhaler for asthma symptoms, and 14.6% used more than 3 canisters of this type of medication in the past 3 months. Of this group, 60% were using daily long-term control medication but still required significant use of quick-relief inhalers, whereas 28% had never used long-term control medication. Of those who had a recent exacerbation, 29% were using daily preventive medication, whereas 54% had never used long-term control medication. CONCLUSIONS: Improvement of asthma control continues to be a US public health concern. Results suggest suboptimal asthma control with underuse of long-term control medications, overuse of quick-relief inhalers, and a significant number of self-reported asthma exacerbations.

Manipulative therapy and rehabilitation for recurrent ankle sprain with functional instability: a short-term, assessor-blind, parallel-group randomized trial.

OBJECTIVE: The purpose of this study was to compare manipulative therapy (MT) plus rehabilitation to rehabilitation alone for recurrent ankle sprain with functional instability (RASFI) to determine short-term outcomes. METHODS: This was an assessor-blind, parallel-group randomized comparative trial. Thirty-three eligible participants with RASFI were randomly allocated to receive rehabilitation alone or chiropractic MT plus rehabilitation. All participants undertook a daily rehabilitation program over the course of the 4-week treatment period. The participants receiving MT had 6 treatments over the same treatment period. The primary outcome measures were the Foot and Ankle Disability Index and the visual analogue pain scale, with the secondary outcome measure being joint motion palpation. Data were collected at baseline and during week 5. Missing scores were replaced using a multiple imputation method. Statistical analysis of the data composed of repeated-measures analysis of variance. RESULTS: Between-group analysis demonstrated a difference in scores at the final consultation for the visual analogue scale and frequency of joint motion restrictions (P ≤ .006) but not for the Foot and Ankle Disability Index (P = .26). CONCLUSIONS: This study showed that the patients with RASFI who received chiropractic MT plus rehabilitation showed significant short-term reduction in pain and the number of joint restrictions in the short-term but not disability when compared with rehabilitation alone.

Manual and manipulative therapy in addition to rehabilitation for osteoarthritis of the knee: assessor-blind randomized pilot trial.

OBJECTIVES: The purpose of this study was to examine the methodological integrity, sample size requirements, and short-term preliminary clinical outcomes of manual and manipulative therapy (MMT) in addition to a rehabilitation program for symptomatic knee osteoarthritis (OA). METHODS: This was a pilot study of an assessor-blinded, randomized, parallel-group trial in 2 independent university-based outpatient clinics. Participants with knee OA were randomized to 3 groups: 6 MMT sessions alone, training in rehabilitation followed by a home rehabilitation program alone, or MMT plus the same rehabilitation program, respectively. Six MMT treatment sessions (provided by a chiropractic intern under supervision or by an experienced chiropractor) were provided to participants over the 4-week treatment period. The primary outcome was a description of the research methodology and sample size estimation for a confirmatory study. The secondary outcome was the short-term preliminary clinical outcomes. Data were collected at baseline and 5weeks using the Western Ontario and McMasters Osteoarthritis Index questionnaire, goniometry for knee flexion/extension, and the McMaster Overall Therapy Effectiveness inventory. Analysis of variance was used to compare differences between groups. RESULTS: Eighty-three patients were randomly allocated to 1 of the 3 groups (27, 28, and 28, respectively). Despite 5 dropouts, the data from 78 participants were available for analysis with 10% of scores missing. A minimum of 462 patients is required for a confirmatory 3-arm trial including the respective interventions, accounting for cluster effects and a 20% dropout rate. Statistically significant and clinically meaningful changes in scores from baseline to week 5 were found for all groups for the Western Ontario and McMasters Osteoarthritis Index (P ≤ .008), with a greater change in scores for MMT and MMT plus rehabilitation. Between-group comparison did not reveal statistically significant differences between group scores at week 5 for any of the outcome measures (P ≥ .46). CONCLUSIONS: This pilot trial suggests that a confirmatory trial is feasible. There were significant changes in scores from baseline to week 5 across all groups, suggesting that all 3 treatment approaches may be of benefit to patients with mild-to-moderate knee OA, justifying a confirmatory trial to compare these interventions.

The relationship between asthma, asthma control and economic outcomes in the United States.

OBJECTIVE: Asthma, a serious chronic lung disease affecting approximately 26 million Americans, remains clinical and economic burdens on the healthcare system. Although associations between uncontrolled asthma and poor health outcomes is known, the extent of this impact of uncontrolled asthma on economic outcomes in the United States (US) is unknown. We sought to determine the relationship between asthma, asthma control and economic outcomes in the US. METHODS: The 2008-2010 Medical Expenditure Panel Surveys were used to estimate the impact of uncontrolled asthma (asthma-related emergency department [ED] visit, use of >3 canisters of quick-relief inhaler in past 3 months or asthma attack in past 12 months) on medical expenditures, utilization and productivity. Estimates were generated using multivariate regression controlling for sociodemographics and comorbidity. RESULTS: Medical expenditures attributable to asthma were up to $4423 greater for those with markers of uncontrolled asthma compared with those who did not have asthma. Frequency of hospital discharges were up to 4.6-fold greater for those with uncontrolled asthma than those without asthma (p < 0.01), while all others with asthma did not have significantly more discharges. ED visits were up to 1.8-fold greater for those with uncontrolled asthma compared with those without asthma (p < 0.01). Productivity was significantly (p < 0.01) decreased (more likely to be unemployed, more days absent from work and more activity limitations) for those with uncontrolled asthma. CONCLUSIONS: In recent national data, individuals with asthma and markers of uncontrolled asthma had higher medical expenditures, greater utilization and decreased productivity.

Asthma in USA: its impact on health-related quality of life.

OBJECTIVES: Given the growing prevalence of asthma in USA, it is important to understand its national burden from the patient's perspective. The objective of this research is to examine the national burden of asthma and poor asthma control on health function, health perception and preference-based health-related quality of life (HRQL). METHODS: The Medical Expenditure Panel Survey (MEPS), a nationally representative survey, was used to estimate the impact of asthma and indicators of poor asthma control on health function, self-rated health perception and preference-based HRQL using multivariate regression methods controlling for socioeconomic, clinical and demographic characteristics. Two HRQL instruments were used: SF-12v2 Physical Component Scale (PCS-12) and Mental Component Scale (MCS-12); EQ-5D-3L index and visual analogue scale (VAS). Two multivariate regression methods were used, Censored Least Absolute Deviation [EQ-5D-3L and VAS (due to censoring)] and Ordinary Least Squares (OLS) (PCS-12 and MCS-12). RESULTS: After controlling for covariates, asthma resulted in a statistically significant reduction in preference-based HRQL, health perception and physical and mental function (EQ-5D -0.023; VAS -2.21; PCS-12 -2.36; MCS-12 -0.96). Likewise, experiencing an exacerbation in the previous year and using more than three canisters of quick-relief medication in the previous 3 months were both associated with a statistically significant and clinically meaningful reduction in all four measures. CONCLUSIONS: Asthma itself and especially indicators of poor asthma control were associated with a deleterious effect on health function, preference-based HRQL and self-perceived health status. Given the prevalence of asthma, poorly controlled asthma constitutes a significant national burden in USA.

Treatment and referral patterns for psoriasis in United Kingdom primary care: a retrospective cohort study.

BACKGROUND: In the UK, referrals to specialists are initiated by general practitioners (GPs). Study objectives were to estimate the incidence of diagnosed psoriasis in the UK and identify factors associated with GP referrals to dermatologists. METHODS: Newly diagnosed patients with psoriasis were identified in The Health Improvement Network (THIN) database between 01 July 2007-31 Oct 2009. Incidence of diagnosed psoriasis was calculated using the number of new psoriasis patients in 2008 and the mid-year total patient count for THIN in 2008. A nested case-control design and conditional logistic regression were used to identify factors associated with referral. RESULTS: Incidence rate of diagnosed adult psoriasis in 2008 was 28/10,000 person-years. Referral rate to dermatologists was 18.1 (17.3-18.9) per 100 person-years. In the referred cohort (N=1,950), 61% were referred within 30 days of diagnosis and their median time to referral was 0 days from diagnosis. For those referred after 30 days (39%, median time to referral: 5.6 months), an increase in the number of GP visits prior to referral increased the likelihood of referral (OR=1.87 95% CI:1.73-2.01). A prescription of topical agents such as vitamin D3 analogues 30 days before referral increased the likelihood of being referred (OR=4.67 95% CI: 2.78-7.84), as did corticosteroids (OR=2.45 95% CI: 1.45-4.07) and tar products (OR=1.95 95% CI: 1.02-3.75). CONCLUSIONS: Estimates of the incidence of diagnosed adult psoriasis, referral rates to dermatologists, and characteristics of referred patients may assist in understanding the burden on the UK healthcare system and managing this population in primary and secondary care.

Full kinetic chain manual and manipulative therapy plus exercise compared with targeted manual and manipulative therapy plus exercise for symptomatic osteoarthritis of the hip: a randomized controlled trial.

OBJECTIVE: To determine the short-term effectiveness of full kinematic chain manual and manipulative therapy (MMT) plus exercise compared with targeted hip MMT plus exercise for symptomatic mild to moderate hip osteoarthritis (OA). DESIGN: Parallel-group randomized trial with 3-month follow-up. SETTING: Two chiropractic outpatient teaching clinics. PARTICIPANTS: Convenience sample of eligible participants (N=111) with symptomatic hip OA were consented and randomly allocated to receive either the experimental or comparison treatment, respectively. INTERVENTIONS: Participants in the experimental group received full kinematic chain MMT plus exercise while those in the comparison group received targeted hip MMT plus exercise. Participants in both groups received 9 treatments over a 5-week period. MAIN OUTCOME MEASURES: Western Ontario and McMasters Osteoarthritis Index (WOMAC), Harris hip score (HHS), and Overall Therapy Effectiveness, alongside estimation of clinically meaningful outcomes. RESULTS: Total dropout was 9% (n=10) with 7% of total data missing, replaced using a multiple imputation method. No statistically significant differences were found between the 2 groups for any of the outcome measures (analysis of covariance, P=.45 and P=.79 for the WOMAC and HHS, respectively). CONCLUSIONS: There were no statistically significant differences in the primary or secondary outcome scores when comparing full kinematic chain MMT plus exercise with targeted hip MMT plus exercise for mild to moderate symptomatic hip OA. Consequently, the nonsignificant findings suggest that there would also be no clinically meaningful difference between the 2 groups. The results of this study provides guidance to musculoskeletal practitioners who regularly use MMT that the full kinematic chain approach does not appear to have any benefit over targeted treatment.

Manipulative therapy for lower extremity conditions: update of a literature review.

OBJECTIVE: The purpose of this study is to update a systematic review on manipulative therapy (MT) for lower extremity conditions. METHODS: A review of literature was conducted using MEDLINE, MANTIS, Science Direct, Index to Chiropractic Literature, and PEDro from March 2008 to May 2011. Inclusion criteria required peripheral diagnosis and MT with or without adjunctive care. Clinical trials were assessed for quality using a modified Scottish Intercollegiate Guidelines Network (SIGN) ranking system. RESULTS: In addition to the citations used in a 2009 systematic review, an additional 399 new citations were accessed: 175 citations in Medline, 30 citations in MANTIS, 98 through Science Direct, 54 from Index to Chiropractic Literature, and 42 from the PEDro database. Forty-eight clinical trials were assessed for quality. CONCLUSIONS: Regarding MT for common lower extremity disorders, there is a level of B (fair evidence) for short-term and C (limited evidence) for long-term treatment of hip osteoarthritis. There is a level of B for short-term and C for long-term treatment of knee osteoarthritis, patellofemoral pain syndrome, and ankle inversion sprain. There is a level of B for short-term treatment of plantar fasciitis but C for short-term treatment of metatarsalgia and hallux limitus/rigidus and for loss of foot and/or ankle proprioception and balance. Finally, there is a level of I (insufficient evidence) for treatment of hallux abducto valgus. Further research is needed on MT as a treatment of lower extremity conditions, specifically larger trials with improved methodology.