Summary Rationale Health-related quality of life (HRQL) is an important outcome in drug trials. Little is known about how the Short Form-36 (SF-36) and Saint George's Respiratory Questionnaire (SGRQ) ...perform in idiopathic pulmonary fibrosis (IPF). Objectives To examine the validity of the SF-36 and SGRQ and to determine scores from each that would constitute a minimum important difference (MID). Methods We analyzed data from a recently completed trial that enrolled subjects with well-defined IPF who completed the SF-36, SGRQ, and Baseline/Transition Dyspnea Index at baseline and six months. We compared mean changes in HRQL scores between groups of subjects whose disease severity changed over six months according to clinical anchors (FVC, DLCO, and dyspnea). We estimated the MID for each domain by using both anchor- and distribution-based approaches. Main results Results supported the validity of the SF-36 and SGRQ for use in longitudinal studies. Mean changes in domain scores differed significantly between subjects whose clinical status improved and those whose clinical status declined according to the anchors. MID estimates for the SF-36 ranged from 2–4 points and from 5–8 points for the SGRQ. Conclusion In IPF, the SF-36 and SGRQ possess reasonable validity for differentiating subjects whose disease severity changes over time. More studies are needed to continue the validation process, to refine estimates of the MIDs for the SF-36 or SGRQ, and to determine if a disease-specific instrument will perform better than either of these.
Background Information comparing subjective and objective measurements of adherence to study medications and the effects of adherence on treatment-related differences in asthma clinical trials are ...limited. Objective We sought to compare subjective and objective measurements of children’s adherence to inhaled corticosteroids or placebo and to determine whether adherence to study medications modified treatment-related differences in outcomes. Methods In an ancillary study conducted in 3 of 8 Childhood Asthma Management Program Clinical Centers, adherence was assessed by using self-reported and objective data in 5- to 12-year-old children with mild or moderate asthma who were randomly assigned to 200 μg of inhaled budesonide twice per day (n = 84) or placebo (n = 56) for 4 years. The κ statistic was used to evaluate agreement between self-reported adherence (daily diary cards) and objectively measured adherence (number of doses left in study inhalers). Multivariable analyses were used to determine whether adherence to study treatment modified treatment-related differences in outcomes. Results Adherence of less than 80% was seen in 75% of 140 children when adherence was measured objectively but only in 6% of children when measured by means of self-report. There was poor agreement between objective and subjective measurements of adherence of at least 80% (κ = 0.00; 95% CI, −0.05 to 0.04); self-reported adherence over the 4-year period generally overestimated objectively measured adherence (93.6% vs 60.8%, P < .0001). There was little evidence to indicate that adherence modified treatment-related differences in outcomes. Conclusion Researchers should use objective rather than self-reported adherence data to identify clinical trial participants with low levels of adherence to study treatment.
To evaluate the relationship between intimate partner violence (IPV) and adult and childhood asthma outcomes.
We conducted a systematic literature review using 4 databases (PubMed, Ovid MEDLINE, Ovid ...Embase, and Ovid PsycINFO) with asthma and IPV-associated terms.
We included published studies, available in English, to October 2021, which included IPV as an exposure and asthma as an outcome. Both adult and pediatric populations were included in the following settings: community, health care, and home.
There were 37 articles identified. There was evidence among multiple studies to support increased prevalence of asthma in adults exposed to IPV and prevalence and incidence in children with parental IPV exposure. There were fewer studies evaluating IPV exposure and adult asthma morbidity, but they found statistically significant associations between IPV and increased rate of asthma exacerbations and worsened asthma control. There was sparse evidence evaluating a relationship between IPV and adult asthma mortality. There were no studies identified evaluating IPV and childhood asthma morbidity or mortality.
The association between IPV and increased asthma prevalence, incidence, and worsened morbidity merits recognition and further investigation into potential mechanisms. Health care providers can implement practical strategies to help mitigate the negative effects of IPV on health and asthma. These include addressing potential impactful biopsychosocial factors and comorbidities, implementing routine screening and referrals, and partnering with community advocacy organizations. Given their positions of respect and power in society, health care providers can have lasting impacts on the lives of pediatric and adult patients affected by IPV.
No formal guidelines exist to guide physicians caring for patients with sarcoidosis in their screening for management of patients with cardiac sarcoidosis. We conducted a modified Delphi study to ...investigate if a consensus could be reached on the best approaches for screening for and management of cardiac sarcoidosis.
A modified Delphi study design with two rounds of questionnaires was used to investigate if a consensus existed among sarcoid experts in the United States on the best management approaches for cardiac sarcoidosis. Experts were identified based on their national reputation as sarcoid experts and by being actively involved in sarcoidosis clinics at their institutions.
Overall agreement was low to moderate. Agreement was reached on the role of history, physical examination, and 12-lead ECG in screening, echocardiogram, Holter monitor, myocardial fluorodeoxyglucose PET scan, and cardiac MRI in workup, and steroids in treatment. Agreement was not reached on the role of signal-averaged ECG in screening, optimum dose of prednisone, use of steroid-sparing agents, and duration of treatment. Several comments underscore the diverse approaches and uncertainty that exist in managing cardiac sarcoidosis.
Our study highlights the dilemma that sarcoid experts face in their approach to cardiac sarcoidosis. It also highlights the lack of agreement among sarcoid experts on key aspects of diagnosis and management and stresses the importance of collaborative efforts to investigate the best strategies for screening for and management of cardiac sarcoidosis.
The response characteristics of the 6 minute walk test (6MWT) in studies of idiopathic pulmonary fibrosis (IPF) are only poorly understood, and the change in walk distance that constitutes the ...minimum important difference (MID) over time is unknown.
To examine changes over time in distance walked (ie, 6MWD) during the 6MWT and to estimate the change in distance that constitutes the MID in patients with IPF.
Data from a recently completed trial that included subjects with IPF who completed the 6MWT, Saint George's Respiratory Questionnaire (SGRQ) and forced vital capacity (FVC) at 6 and 12 months were used to examine longitudinal changes in 6MWD. Both anchor- and distribution-based approaches as well as linear regression analyses were used to determine the MID for 6MWD. The SGRQ Total score and FVC were used as clinical anchors.
Among 123 subjects alive and able to complete the 6MWT at both follow-up time points, 6MWD did not change significantly over time (378.1 m at baseline vs 376.8 m at 6 months vs 361.3 m at 12 months, p=0.5). The point estimate for the 6MWD MID was 28 m with a range of 10.8-58.5 m.
In a group of patients with IPF with moderate physiological impairment, for those alive and able to complete a 6MWT, 6MWD does not change over 12 months. At the population level, the MID for 6MWD appears to be approximately 28 m. Further investigation using other anchors and derivation methods is required to refine estimates of the MID for 6MWD in this patient population.
In a secondary analysis of data from a prior study, we calculated the relationships among depression (PHQ-8), anxiety (GAD-7), and measures of asthma in 69 steroid-naïve patients with mild and ...moderate symptomatic asthma. Average levels of pulmonary function, depression and anxiety tended to be in the normal range, and asthma tended to be well controlled (Asthma Control Test). Nevertheless, PHQ-8 scores were significantly correlated with forced oscillation (FO) measures of airway reactance (AX) and resistance at a low frequency of stimulation (Rrs5 Hz). GAD-7 scores also were significantly related to Rrs5 Hz. Exploratory analyses in Supplementary data provide no evidence for vagal mediation of the association. Further research is necessary to discover mechanisms for the associations found here. Future studies might examine the utility of assessing and treating mild anxiety and depression in mild to moderate asthma.
•Airway measures correlate with depression and anxiety in patients with mild symptoms.•Forced oscillation is sensitive to emotional variations in mild asthma.•Treating nonclinical depression and anxiety in mild asthma may be beneficial.
There is no disease-specific instrument to assess health-related quality of life (HRQL) in patients with idiopathic pulmonary fibrosis (IPF).
Patients' perspectives were collected to develop domains ...and items for an IPF-specific HRQL instrument. We used item variance and Rasch analysis to construct the ATAQ-IPF (A Tool to Assess Quality of life in IPF).
The ATAQ-IPF version 1 is composed of 74 items comprising 13 domains. All items fit the Rasch model. Domains and the total instrument possess acceptable psychometric characteristics for a multidimensional questionnaire. The pattern of correlations between ATAQ-IPF scores and physiologic variables known to be important in IPF, along with significant differences in ATAQ-IPF scores between subjects using versus those not using supplemental oxygen, support its validity.
Patient-centered and careful statistical methodologies were used to construct the ATAQ-IPF version 1, an IPF-specific HRQL instrument. Simple summation scoring is used to derive individual domain scores as well as a total score. Results support the validity of the ATAQ-IPF, and future studies will build on that validity.
The etiologies for difficult-to-control asthma are complex and incompletely understood. Intimate partner violence (IPV) is a pervasive problem and may play a role in difficult-to-control asthma. IPV ...is associated with increased prevalence of asthma. There are no prior studies evaluating IPV's association with adult asthma exacerbations.
This study hypothesized that IPV exposure would be associated with increased asthma exacerbations, higher symptom burden, and poorer asthma control among adults.
Analyses are based on 2634 adults who participated in the 2005 Behavioral Risk Factor Surveillance System survey, reported active asthma, and completed the asthma and IPV questions. We used multivariate logistic regression to examine the association of IPV with asthma morbidity outcomes while controlling for the following potential confounders: sex, race, education, health care coverage, smoking status, age, and body mass index.
The prevalence of IPV was 32.4%. IPV was associated with increased odds of an asthma exacerbation (adjusted odds ratio AOR = 1.75, 95% confidence interval CI = 1.26-2.43), higher symptom burden (AOR = 2.33, 95% CI = 1.53-3.55), and lack of asthma control (AOR = 2.23, 95% CI = 1.22-4.09) when using composite measures for these outcomes. When using single-item measures for outcomes, IPV was also associated with increased asthma-related emergency department or urgent care visits (AOR = 2.35, 95% CI = 1.56-3.54), other urgent provider visits (AOR = 1.84, 95% CI = 1.28-2.64), perceived asthma attacks (AOR = 1.53, 95% CI = 1.12-2.09), limitations (AOR = 2.07, 95% CI = 1.49-2.89), daytime symptoms (AOR = 1.92, 95% CI = 1.35-2.72), and nocturnal awakenings (AOR = 1.88, 95% CI = 1.32-2.69).
IPV is prevalent in adult asthmatics and consistently and significantly associated with worsened adult asthma morbidity, even after adjusting for key confounders. Further research is needed to more fully understand the mechanisms underlying these relationships.
Most patients with asthma take fewer than half of prescribed doses of controller medication. Interventions to improve adherence have typically been costly, impractical, and at best only minimally ...successful.
To test a speech recognition (SR) intervention to improve adherence to pediatric asthma controller medication.
The Breathe Well study was a 24-month pragmatic randomized clinical trial. The study was conducted within Kaiser Permanente Colorado, a large, group-model health maintenance organization. A total of 1187 children aged 3 to 12 years with a persistent asthma diagnosis and prescription for an inhaled corticosteroid were randomized to the computerized SR intervention or usual care condition and followed up for 24 months between October 2009 and February 2013.
Speech recognition telephone calls to parents in the intervention condition were triggered when an inhaled corticosteroid refill was due or overdue. Calls were automatically tailored with medical and demographic information from the electronic health record and from parent answers to questions in the call regarding recent refills or a desire to receive help refilling, learn more about asthma control, or speak with an asthma nurse or pharmacy staff member.
Adherence to pediatric asthma controller medication, measured as the medication possession ratio over 24 months.
In the intention-to-treat analysis, inhaled corticosteroid adherence was 25.4% higher in the intervention group than in the usual care group (24-month mean SE adherence, 44.5% 1.2% vs 35.5% 1.1%, respectively; P < .001). Asthma-related urgent care events did not differ between the 2 groups. The intervention effect was consistent in subgroups stratified by age, sex, race/ethnicity, body mass index, and disease-related characteristics.
The intervention's significant impact on adherence demonstrates strong potential for low-cost SR adherence programs integrated with an electronic health record. The absence of change in urgent care visits may be attributable to the already low number of asthma urgent care visits within Kaiser Permanente Colorado. Application of electronic health record-leveraged SR interventions may reduce health care utilization when applied in a population with less-controlled asthma.
clinicaltrials.gov Identifier: NCT00958932.
Background
The comparative effectiveness study (ClinicalTrials.gov, NCT03016403) assessed the effects of a stepped‐care intervention versus usual care on mental health outcomes, including anxiety, ...depression, coping self‐efficacy, emotional distress (anxiety and depression combined), health‐related quality of life (HRQoL), and perceived stress among underserved patients (i.e., low‐income, uninsured, underinsured) with lung cancer (LC) and head‐and‐neck cancer (HNC).
Methods
In a randomized controlled trial, we investigated if 147 patients who received the stepped‐care intervention had better mental health outcomes compared to 139 patients who received usual care. Using an intent‐to‐treat approach, we analyzed outcomes with linear mixed models.
Results
For the primary outcomes estimated mean differences (denoted by “Δ”), depression (Δ = 1.75, 95% CI = 0.52, 2.98, p = 0.01) and coping self‐efficacy (Δ = −15.24, 95% CI = −26.12, −4.36, p = 0.01) were better for patients who received the intervention compared to patients who received usual care, but anxiety outcomes were not different. For secondary outcomes, emotional distress (Δ = 1.97, 95% CI: 0.68, 3.54, p =< 0.01) and HRQoL (Δ = −4.16 95% CI: −7.45, −0.87, p = 0.01) were better for patients who received the intervention compared to usual care patients, while perceived stress was not different across groups.
Conclusions
The stepped‐care intervention influenced depression and coping self‐efficacy, important outcomes for patients with acute illnesses like LC and HNC. Although differences in emotional distress met the minimally important differences (MID) previously reported, depression and HRQoL were not above the MID threshold. Our study is among a few to report differences in mental health outcomes for underserved LC and HNC patients after receiving a psychological intervention.
ClinicalTrials.gov identifier
NCT03016403.
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