Inhaler device feature preferences among patients with obstructive lung diseases: A systematic review and meta-analysis.

BACKGROUND: Bronchodilators administered through inhalation devices are the mainstay treatment for patients with obstructive lung diseases. Patients do not view devices as interchangeable. This systematic review and meta-analysis examined device feature preferences among patients with obstructive lung diseases treated with handheld inhalers. STUDY APPRAISAL AND SYNTHESIS METHODS: PubMed, EMBASE, PsycINFO, Cochrane, and Google Scholar were searched to identify publications between 2010 and 2019 that met the following criteria:A manual search extended the study period from 2001 to 2019. Random-effects models were used to generate pooled mean effect sizes and 95% confidence intervals (CIs) for preferred device features. Heterogeneity was measured by the I statistic. RESULTS: Nineteen studies (n = 11,256) were included in this meta-analysis. Average age ranged from 50.4 to 74.3 years. The majority of patients were male (57%) and had chronic obstructive pulmonary disease (92%).Patients preferred the following device features: CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS:: Adults with obstructive lung diseases preferred small inhaler devices that were portable, durable, perceived as easy to use, and fast in medication administration. Healthcare providers should give due consideration to the patient's device feature preferences when developing a treatment plan that prescribes an inhalation device.

Device use errors with soft mist inhalers: A global systematic literature review and meta-analysis.

Inhaled bronchodilators are the cornerstone of treatment for chronic obstructive pulmonary disease (COPD). Soft mist inhalers (SMIs) are devices that deliver bronchodilators. Although correct device use is paramount to successful medication delivery, patient errors are common. This global systematic literature review and meta-analysis examined device use errors with SMIs among patients with obstructive lung diseases. PubMed, EMBASE, PsycINFO, Cochrane, and Google Scholar were searched to identify studies published between 2010 and 2019 that met the following inclusion criteria: (a) English language; (b) a diagnosis of COPD, bronchitis, or emphysema; and (c) reported device use errors among adults receiving long-acting bronchodilator treatment with Respimat® SMI (i.e. Spiriva®, Stiolto®, Spiolto®, and Striverdi®). Descriptive statistics examined sociodemographics, clinical characteristics, and device use errors. Meta-analysis techniques were employed with random-effects models to generate pooled mean effect sizes and 95% confidence intervals (CIs) for overall and step-by-step errors. The I2 statistic measured heterogeneity. Twelve studies (n = 1288 patients) were included in this meta-analysis. Eighty-eight percent of patients had COPD, and most had moderate/very severe airflow limitation (Global Initiative for Chronic Obstructive Lung Disease spirometric stages II to IV). Aggregate results revealed that 58.9% (95% CI: 42.4-75.5; I2 = 92.8%) of patients made ≥1 device use errors. Among 11 studies with step-by-step data, the most common errors were failure to (1) exhale completely and away from the device (47.8% (95% CI: 33.6-62.0)); (2) hold breath for up to 10 seconds (30.6% (95% CI: 17.5-43.7)); (3) take a slow, deep breath while pressing the dose release button (27.9% (95% CI: 14.5-41.2)); (4) hold the inhaler upright (22.6% (95% CI: 6.2-39.0)); and (5) turn the base toward the arrows until it clicked (17.6% (95% CI: 3.0-32.2)). Device use errors occurred in about 6 of 10 patients who used SMIs. An individualized approach to inhalation device selection and ongoing training and monitoring of device use are important in optimizing bronchodilator treatment.

Exacerbations, Health Resource Utilization, and Costs Among Medicare Beneficiaries with Chronic Obstructive Pulmonary Disease Treated with Nebulized Arformoterol Following a Respiratory Event.

BACKGROUND: Long-acting beta2-agonists (LABAs), with or without inhaled corticosteroids (ICSs), delivered by handheld inhalers or nebulizers are recommended as maintenance therapy in chronic obstructive pulmonary disease (COPD). This study evaluated exacerbations, health resource utilization (HRU), and costs among Medicare beneficiaries with COPD on handheld ICS+LABA who switched to nebulized arformoterol (ARF) or continued ICS+LABA following a respiratory event. METHODS: Using Medicare claims, we identified beneficiaries with COPD (international classification of disease, 9th revision, clinical modification [ICD-9-CM] 490-492.xx, 494.xx, 496.xx) between 2010-2014 who had ≥ 1 year of continuous enrollment in Parts A, B, and D; ≥ 2 COPD-related outpatient visits ≥ 30 days apart or ≥ 1 hospitalization(s); ICS+LABA use 90-days before ARF initiation; and a respiratory event (COPD-related hospitalization or emergency department [ED] visit < 30 days before ARF initiation). Using propensity scores, 423 beneficiaries who switched to ARF were matched to 423 beneficiaries who continued on handheld ICS+LABA (controls). Difference-in-difference regression models examined outcomes at 180-days follow-up. RESULTS: Beneficiaries who switched to ARF had 1.5 fewer exacerbations (p=0.015) but no difference in hospitalizations and ED visits compared to controls. Durable medical equipment (DME) costs were higher among ARF users than controls ($1590), yet total health care costs were similar due to cost offsets by ARF in pharmacy (-$794), inpatient (-$524), and outpatient care (-$65). ARF accounted for 55% ($886.63) of DME costs, with the remaining costs attributed to oxygen therapy ($428.10) and nebulized corticosteroids ($590.85). CONCLUSIONS: Switching from handheld ICS+LABA to nebulized ARF resulted in fewer COPD exacerbations among Medicare beneficiaries. Nebulized LABAs may improve outcomes in selected patients with COPD.

Inhalation Technique Errors with Metered-Dose Inhalers Among Patients with Obstructive Lung Diseases: A Systematic Review and Meta-Analysis of U.S. Studies.

BACKGROUND: Metered dose inhalers (MDIs) are commonly prescribed for inhalation therapy, but correct use is critical to promoting effective medication delivery. This systematic literature review and meta-analysis evaluates the overall and step-by-step prevalence of errors among adults with obstructive lung diseases in the United States who used MDIs. METHODS: Electronic and manual searches conducted between 1979-2018 using PubMed, EMBASE, PsycINFO, Cochrane, and Google identified 10 articles that met the following inclusion criteria: (a) English language, (b) U.S. adults diagnosed with chronic obstructive pulmonary disease, and (c) MDI use error rates. Meta-analytic techniques using random-effects models were applied to calculate effect sizes, weighted proportions, and 95% confidence intervals (CIs). Heterogeneity was assessed by the I2 statistic. RESULTS: Aggregate findings revealed that 86.7% of patients (n=390, 95% CI 77.5-96.0) made at least 1 inhalation technique error, and 76.9% (n=885, 95% CI 65.8-87.9) incorrectly performed ≥ 20% of device use steps. The most prevalent step-by-step errors across the studies (n=1105) were failure to: (a) exhale fully and away from the inhaler before inhalation (65.5% [95% CI 52.0, 78.9]); (b) hold breath for 5-10 seconds (41.9% [95% CI 29.8, 53.9]); (c) inhale slowly and deeply (39.4% [95% CI 26.2, 52.5]); (d) exhale after inhalation (35.9% [95% CI 17.0, 54.8]); and (e) shake the inhaler before use (34.2% [95% CI 30.6, 37.7]). CONCLUSIONS: Across the studies used in this meta-analysis more than three-fourths of U.S. adults with obstructive lung diseases used MDIs incorrectly. Our findings suggest the need for ongoing patient education and consideration of alternative devices to mitigate errors.

Predictors of Nebulized Arformoterol Treatment: A Retrospective Analysis of Medicare Beneficiaries with Chronic Obstructive Pulmonary Disease.

This study examined sociodemographic and clinical characteristics, treatment patterns, and health resource utilization among Medicare beneficiaries with chronic obstructive pulmonary disease (COPD) to identify predictors of nebulized arformoterol treatment. Using Medicare administrative data from 2010 to 2014, beneficiaries with ≥2 COPD outpatient visits ≥30 d apart or ≥1 COPD-related hospitalization(s) (ICD-9-CM 491.xx, 492.xx, and 496) were identified. Inclusion criteria required ≥1 COPD medication claim(s) and continuous enrollment in Parts A, B, and D. Four cohorts were identified: (a) 11,887 arformoterol users, (b) a subsample of arformoterol users (n = 1,778) who were hospitalized and discharged 30 d before initiating arformoterol, (c) 450,178 controls who had not received arformoterol, and (d) a subsample of controls (n = 21,910) who had hospitalizations. Logistic regression analysis was used to evaluate predictors of arformoterol treatment. The majority of beneficiaries were older than 70 years of age, female, Caucasian, and 47% were dual-eligible. The strongest predictors of arformoterol treatment were oxygen therapy, systemic corticosteroid or methylxanthine use, an exacerbation, a COPD-related hospitalization, and receiving care from a pulmonologist (all p < .001). Dual-eligibility, being a racial/ethnic minority, and having severe psychiatric comorbidity or immunodeficiency lowered the odds of receiving nebulized arformoterol (all p < .001). Among beneficiaries with recent hospitalizations, exacerbations and COPD-related admissions increased the odds of receiving arformoterol (p < .001). Nebulized arformoterol treatment was more likely to be initiated in sicker patients with COPD. Ensuring access to nebulized maintenance therapy is important and particularly warranted for COPD populations with greater medical needs.

Medication management patterns among Medicare beneficiaries with chronic obstructive pulmonary disease who initiate nebulized arformoterol treatment.

Purpose: Global evidence-based treatment strategies for chronic obstructive pulmonary disease (COPD) recommend using long-acting bronchodilators (LABDs) as maintenance therapy. However, COPD patients are often undertreated. We examined COPD treatment patterns among Medicare beneficiaries who initiated arformoterol tartrate, a nebulized long-acting beta2 agonist (LABA), and identified the predictors of initiation. Methods: Using a 100% sample of Medicare administrative data, we identified beneficiaries with a COPD diagnosis (ICD-9 490-492.xx, 494.xx, 496.xx) between 2010 and 2014 who had ≥1 year of continuous enrollment in Parts A, B, and D, and ≥2 COPD-related outpatient visits within 30 days or ≥1 hospitalization(s). After applying inclusion/exclusion criteria, three cohorts were identified: (1) study group beneficiaries who received nebulized arformoterol (n=11,886), (2) a subset of the study group with no LABD use 90 days prior to initiating arformoterol (n=5,542), and (3) control group beneficiaries with no nebulized LABA use (n=220,429). Logistic regression was used to evaluate predictors of arformoterol initiation. Odds ratios (ORs), 95% confidence intervals (CIs), and p values were computed. Results: Among arformoterol users, 47% (n=5,542) had received no LABDs 90 days prior to initiating arformoterol. These beneficiaries were being treated with a nebulized (50%) or inhaled (37%) short-acting bronchodilator or a systemic corticosteroid (46%), and many received antibiotics (37%). Compared to controls, beneficiaries who initiated arformoterol were significantly more likely to have had an exacerbation, a COPD-related hospitalization, and a pulmonologist or respiratory therapist visit prior to initiation (all p<0.05). Beneficiaries with moderate/severe psychiatric comorbidity or dual-eligible status were significantly less likely to initiate arformoterol, as compared to controls (all p<0.05). Conclusion: Medicare beneficiaries who initiated nebulized arformoterol therapy had more exacerbations and hospitalizations than controls 90 days prior to initiation. Findings revealed inadequate use of maintenance medications, suggesting a lack of compliance with evidence-based treatment guidelines.

Impact of an Individualized Physical Activity Intervention on Improving Mental Health Outcomes in Family Caregivers of Persons with Dementia: A Randomized Controlled Trial.

PURPOSE: This study examined secondary benefits of an individualized physical activity intervention on improving dementia family caregivers' subjective burden, depressive symptoms and positive affect. DESIGN AND METHODS: A community-based randomized controlled trial (RCT) was implemented with family caregivers of persons with dementia (N = 211) who received the Enhanced Physical Activity Intervention (EPAI: treatment intervention, n = 106) or the Caregiver Skill Building Intervention (CSBI: control intervention, n = 105). Interventions were delivered over 12 months, including a baseline home visit and regularly spaced telephone calls. Data were collected in person at baseline, 6 and 12-months; and telephonically at 3 and 9-months. The EPAI integrated physical activity and caregiving content while the CSBI focused only on caregiving content. Descriptive, bivariate and intention-to-treat analyses using generalized estimating equations (GEE) were performed to examine secondary benefits of the EPAI on family caregiver burden, depressive symptoms and positive affect. RESULTS: Compared to caregivers in the CSBI group, caregivers in the EPAI significantly increased their overall and total moderate physical activity and showed a positive interaction between the intervention and time for positive affect at both six (p = 0.01) and 12-months (p = 0.03). The EPAI was significantly associated with improving burden at 3 months (p = 0.03) but had no significant effect on depressive symptoms. IMPLICATIONS: Caregiver involvement in an individualized physical activity intervention was associated with increased overall and total moderate physical activity and improved positive affect from baseline to 12 months. Improved positive affect may help caregivers to feel better about themselves and their situation, and better enable them to continue providing care for their family member for a longer time at lower risk to their own mental health.

Exacerbations, health services utilization, and costs in commercially-insured COPD patients treated with nebulized long-acting ß2-agonists.

OBJECTIVE: This retrospective cohort study compared exacerbations, health services utilization, and costs among chronic obstructive pulmonary disease (COPD) patients who received nebulized arformoterol or nebulized formoterol therapy. METHODS: Using PharMetrics Plus health plan claims, 417 nebulized long-acting ß2-agonist (LABA) users meeting the study inclusion criteria were identified: had ≥2 fills of nebulized arformoterol or nebulized formoterol from January 1, 2009, to December 31, 2011, adhered to using their index drug ≥60% of the days during 1 year post-index, were ≥35 years old and continuously enrolled 180 days pre- and 1 year post-index, and did not use a nebulized LABA or have an asthma diagnosis during the pre-index period. Descriptive and multivariate analyses were performed. RESULTS: A total of 274 nebulized arformoterol users and 143 nebulized formoterol users were identified with comparable demographic characteristics. However, significant differences were observed between the two groups in some clinical characteristics at index including comorbidities and use of antibiotics. At 1 year post-index, a lower proportion of nebulized arformoterol users had ≥1 exacerbation compared to nebulized formoterol users (70.4% vs 80.4%; p = 0.028). Among patients with ≥1 hospital admission, COPD-related costs per inpatient stay were significantly lower for nebulized arformoterol users than nebulized formoterol users (median = $9542 vs $14,025; p = 0.009). After controlling for confounders, nebulized arformoterol users had 19% marginally lower risk of exacerbations than nebulized formoterol users (hazard ratio = 0.81, 95% confidence interval = 0.64-1.03; p < 0.084) and 14.4% marginally lower COPD-related total costs at 1 year post-index (p = 0.062), primarily related to fewer hospital readmissions (7.6% vs 12.2%) and lower average costs per readmission stay (median = $7392 vs $18 081; p = 0.006). CONCLUSIONS: This study suggests that the choice of nebulized LABA may influence COPD-related exacerbation occurrence and costs. Future studies with larger and more closely matched nebulized arformoterol and nebulized formoterol users are needed to confirm these findings.

Diagnostic approach, treatment, and outcomes of cervical sympathetic chain schwannomas: a global narrative review.

OBJECTIVE: This review examined the diagnostic approach, surgical treatment, and outcomes of cervical sympathetic chain schwannomas (CSCS) to guide clinical decision making. DATA SOURCES: Medline, EMBASE, and Cochrane databases. REVIEW METHODS: A literature review from 1998 to 2013 identified 156 articles of which 51 representing 89 CSCS cases were evaluated in detail. Demographic, clinical, and outcomes data were extracted by 2 independent reviewers with high interrater reliability (κ = .79). Cases were mostly international (82%), predominantly from Asia (50%) and Europe (27%). CONCLUSIONS: On average, patients were 42.6 years old (SD = 13.3) and had a neck mass ranging between 2 to 4 cm (52.7%) or >4 cm (43.2%). Nearly 70% of cases were asymptomatic at presentation. Presurgical diagnosis relied on CT (63.4%), MRI (59.8%), or both (19.5%), supplemented by cytology (33.7%), which was nearly always inconclusive (96.7%). US-treated cases were significantly more likely to receive presurgical MRI than internationally treated cases but less likely to have cytology (P < .05). Presurgical diagnosis was challenging, with only 11% confirmatory accuracy postsurgically. Irrespective of mass size, extracapsular resection (ie, complete resection with nerve sacrifice) was the most frequently (87.6%) performed surgical procedure. Common postsurgical adverse events included Horner's syndrome (91.1%), first bite syndrome (21.1%), or both (15.7%), with higher prevalence when mass size was >4 cm. Adverse events persisted in 82.3% of cases at an average 30.0 months (SD = 30.1) follow-up time. IMPLICATIONS FOR PRACTICE: Given the typical CSCS patient is young and asymptomatic and the likelihood of persistent morbidity is high with standard surgical approaches, less invasive treatment options warrant consideration.

Stellate ganglion block improves refractory post-traumatic stress disorder and associated memory dysfunction: a case report and systematic literature review.

The prevalence of post-traumatic stress disorder (PTSD) has reached epidemic proportions among U.S. veterans, many of whom also have concurrent alcohol use disorder. This case report describes improvements in PTSD symptom severity and memory dysfunction in a combat-exposed veteran with persistent PTSD and alcohol use disorder following two treatments of stellate ganglion block (SGB). PTSD severity was measured using the PTSD Checklist, Military Version. Memory function was evaluated using the Rey Auditory Verbal Learning Test. One month after the first SGB, a 43.6% reduction in PTSD severity was observed along with increases in immediate memory (50%), recent memory (28%), and recognition memory (25%). Following a second SGB, PTSD severity decreased by 57.7% and memory function substantially improved, with pronounced changes in immediate memory (50%), recent memory (58%), and recognition memory (36%). One year after SGB treatments, the patient has stopped drinking alcohol, continues to have sustained relief from PTSD, has improved memory function, and has become gainfully employed. Future studies that employ robust epidemiologic methodologies are needed to generate confirmatory evidence that would substantiate SGB's clinical utility as an adjunctive treatment option for PTSD.

Joint chondrolysis.

Although the disease was first described in the hip, reports of chondrolysis in nearly all diarthrodial joints have since emerged with considerable variations in the literature.Despite speculation among clinicians and researchers about the implicit causal pathways and etiologic contributors associated with chondrolysis, definitive answers remain elusive.The term chondrolysis has been applied to varied levels of joint cartilage destruction from focal chondral defects to diffuse cartilage loss, revealing a lack of consistency in the application of diagnostic criteria to guide differential disease classification.Differentiating between the various potential etiologies associated with chondrolysis provides opportunities for the prevention of the disease.

Glenohumeral chondrolysis after arthroscopy: a systematic review of potential contributors and causal pathways.

PURPOSE: This systematic review provides (1) a synthesis of existing clinical evidence that helps identify factors associated with the development of glenohumeral chondrolysis after arthroscopy (PAGCL), (2) a consolidated conceptualization of potential causal pathways that elucidate proposed mechanisms leading to PAGCL, and (3) a summary of implications for practice, policy, and future research. METHODS: A computerized literature review using an iterative search process identified 245 publications in English between January 1960 and April 2009. After we applied inclusion and exclusion criteria, 35 articles were stratified into 4 categories of factors related to PAGCL: (1) patient factors, (2) surgical factors (preoperative and intraoperative), (3) postoperative factors, and (4) causal pathways. RESULTS: The majority of studies (61%) focused on surgical factors correlated with PAGCL, and most were laboratory based (n = 21). Publications involving human subjects were descriptive case reports (n = 15), not epidemiologic studies. A total of 88 patients (91 shoulder surgeries) with PAGCL were identified in case reports. The majority of patients (55%) was male, and the mean age was 27.9 years (range, 13.1 to 64 years). Among patients, 68% (n = 53) had implants/anchors, 67% (n = 59) received local anesthetics through a pain pump, and 45% (n = 41) had surgeries involving radiofrequency devices. The causal pathways to PAGCL likely involve initiating and secondary cartilage injury due to mechanical, thermal, or chemical events. The result is a cascade of interactive cellular responses that may include inflammation and chondrocyte apoptosis causing disturbance of cellular metabolism with subsequent loss of the gliding surface, congruity, and synovial fluid, leading to increased friction and accelerated wear that ultimately yield PAGCL. CONCLUSIONS: The literature is limited to correlates, rather than true risk factors, for PAGCL. Well-designed epidemiologic studies that examine various exposures in relation to health outcomes, while controlling for potential confounders, are needed to determine relative risks that allow causal inference, thereby facilitating sound practice and policy decision making. LEVEL OF EVIDENCE: Level IV, systematic review.