Health System Approach to Improve Chronic Obstructive Pulmonary Disease Care after Hospital Discharge: Stepped-Wedge Clinical Trial.

Rationale: Patients discharged from the hospital for chronic obstructive pulmonary disease (COPD) exacerbation have impaired quality of life and frequent readmission and death. Clinical trials to reduce readmission demonstrate inconsistent results, including some demonstrating potential harms. Objectives: We tested whether a pragmatic proactive interdisciplinary and virtual review of patients discharged after hospitalization for COPD exacerbation would improve quality of life, using the Clinical COPD Questionnaire, and reduce all-cause 180-day readmission and/or mortality. Methods: We performed a stepped-wedge clinical trial. We enrolled primary care providers and their patients after hospital discharge for COPD at two Department of Veterans Affairs medical centers and 10 outpatient clinics. A multidisciplinary team reviewed health records and developed treatment recommendations delivered to primary care providers via E-consult. We facilitated uptake by entering recommendations as unsigned orders that could be accepted, modified, or canceled. Providers and patients made all final treatment decisions. Measurements and Main Results: We enrolled 365 primary care providers. Over a 30-month period, 352 patients met eligibility criteria, with 191 (54.3%) patients participating in the control and 161 (45.7%) in the intervention. The intervention led to clinically significant better Clinical COPD Questionnaire scores (-0.47; 95% confidence interval [CI], -0.85 to -0.09; 52.6% missing) but did not reduce 180-day readmission and/or mortality (adjusted odds ratio, 0.83; 95% CI, 0.49 to 1.38), in part because of wide CIs. Among the 161 patients in the intervention group, we entered 519 recommendations as unsigned orders, of which 401 (77.3%) were endorsed. Conclusions: A pragmatic health system-level intervention that delivered proactive specialty supported care improved quality of life but did not reduce 180-day readmission or death. Clinical trial registered with www.clinicaltrials.gov (NCT02021955).

Impact of mail-based continuous positive airway pressure initiation on treatment usage and effectiveness.

PURPOSE: In-person visits with a trained therapist have been standard care for patients initiating continuous positive airway pressure (CPAP). These visits provide an opportunity for hands-on training and an in-person assessment of mask fit. However, to improve access, many health systems are shifting to remote CPAP initiation with equipment mailed to patients. While there are potential benefits of a mailed approach, relative patient outcomes are unclear. Specifically, many have concerns that a lack of in-person training may contribute to reduced CPAP adherence. To inform this knowledge gap, we aimed to compare treatment usage after in-person or mailed CPAP initiation. METHODS: Our medical center shifted from in-person to mailed CPAP dispensation in March 2020 during the COVID-19 pandemic. We assembled a cohort of patients with newly diagnosed obstructive sleep apnea (OSA) who initiated CPAP in the months before (n = 433) and after (n = 186) this shift. We compared 90-day adherence between groups. RESULTS: Mean nightly PAP usage was modest in both groups (in-person 145.2, mailed 140.6 min/night). We did not detect between-group differences in either unadjusted or adjusted analyses (adjusted difference - 0.2 min/night, 95% - 27.0 to + 26.5). CONCLUSIONS: Mail-based systems of CPAP initiation may be able to improve access without reducing CPAP usage. Future work should consider the impact of mailed CPAP on patient-reported outcomes and the impact of different remote setup strategies.

Protocol for a pragmatic trial testing a self-directed lifestyle program targeting weight loss among patients with obstructive sleep apnea (POWER Trial).

BACKGROUND: Obesity comprises the single greatest reversible risk factor for obstructive sleep apnea (OSA). Despite the potential of lifestyle-based weight loss services to improve OSA severity and symptoms, these programs have limited reach. POWER is a pragmatic trial of a remote self-directed weight loss care among patients with OSA. METHODS: POWER randomizes 696 patients with obesity (BMI 30-45 kg/m2) and recent diagnosis or re-confirmation of OSA 1:1 to either a self-directed weight loss intervention or usual care. POWER tests whether such an intervention improves co-primary outcomes of weight and sleep-related quality of life at 12 months. Secondary outcomes include sleep symptoms, global ratings of change, and cardiovascular risk scores. Finally, consistent with a hybrid type 1 approach, the trial embeds an implementation process evaluation. We will use quantitative and qualitative methods including budget impact analyses and qualitative interviews to assess barriers to implementation. CONCLUSIONS: The results of POWER will inform population health approaches to the delivery of weight loss care. A remote self-directed program has the potential to be disseminated widely with limited health system resources and likely low-cost.

Development and validation of the effectiveness of [corrected] auditory rehabilitation scale.

OBJECTIVE: To develop a new scale of hearing-related function and quality of life in patients with hearing aids that addresses overlooked concerns, such as hearing-aid comfort, convenience, and cosmetic appearance, that may influence hearing-aid adherence while maintaining brevity and sensitivity to clinical change. DESIGN: Prospective, multicenter instrument validation. SETTING: Four diverse sites in Washington State, including 2 private practices, 1 university setting, and 1 Veterans Affairs hospital. PATIENTS: Seventy-eight patients with hearing aids. INTERVENTIONS: We created 2 modules in the Effectiveness of Auditory Rehabilitation (EAR) scale. The first module (Inner EAR) covers intrinsic hearing issues such as hearing in quiet and hearing in noise and is administered both before and after treatment. The second module (Outer EAR) covers extrinsic (hearing-aid related) issues such as comfort, appearance, and convenience and is administered after hearing-aid fitting. MAIN OUTCOME MEASURES: Both scales were developed and validated in 3 stages. Stage 1 used a qualitative approach from multiple data sources to develop preliminary instruments. Stage 2 used approaches from classic test theory to reduce the number of items and psychometrically validate the instruments. Stage 3 examined the responsiveness or sensitivity to clinical change. RESULTS: A 10-item Inner EAR module and a 10-item Outer EAR module were created and validated. Internal consistency of individual domains (Cronbach alpha = 0.85 and 0.72, respectively) and test-retest reliability (intraclass correlation coefficients = 0.76 and 0.81, respectively) were excellent. Evidence of construct validity included concurrent validity with other hearing scales and global visual analog scales, discriminant validity with dizziness handicap, correlation with hearing-aid adherence, and confirmatory factor analyses. Both scales had strong evidence of responsiveness (sensitivity to change), with higher effect sizes and Guyatt responsiveness statistics than the 2 widely used hearing scales in this study. The scales took an average of 5 minutes to complete. CONCLUSIONS: The EAR scale is a valid and reliable measure of the effectiveness of amplification in the treatment of sensorineural hearing loss. It addresses the range of issues that are of importance to hearing-aid patients. The scales have excellent psychometric properties, are more responsive than several widely used hearing scales, and are minimally burdensome for patients to complete. The EAR may be a valuable outcome measure in future studies of both existing hearing aids and newer hearing-aid technologies, such as bone-anchored aids or middle ear implants.

Environmental cadmium levels increase phytochelatin and glutathione in lettuce grown in a chelator-buffered nutrient solution.

Phytochelatins are enzymatically synthesized peptides involved in metal detoxification and have been measured in plants grown at very high Cd concentrations, but few studies have examined the response of plants at lower environmentally relevant Cd concentrations. Using an ethylenediaminetetraacetic acid (EDTA)-buffered nutrient medium, we have varied Cd exposure and measured phytochelatin and glutathione concentrations in romaine lettuce (Lactuca sativa L. var. longifolia Lam. var. Parris Island) grown in a flow-through hydroponic (FTH) system. Very low free ionic Cd (10(-9.6) M) increased average phytochelatin concentrations above those of controls, and increasing Cd resulted in increased phytochelatin production, though increases were tissue dependent. Glutathione concentrations also increased with increasing Cd. In other standard hydroponic experiments, the media were manipulated to vary total Cd concentration while the ionic Cd was fixed. We found that the total amount of Cd (primarily EDTA bound) in the medium altered thiol production in roots, whereas thiols in leaves remained constant. The Cd uptake into roots and translocation to old leaves was also influenced by the total concentration in the medium. Cadmium in all tissues was lower and in some tissues thiol concentrations were higher than in FTH-grown plants grown in identical medium, suggesting that nutrient delivery technique is also an important variable. Though phytochelatin and glutathione production can be sensitive to changes in bioavailable Cd, thiol concentrations will not necessarily reflect the Cd content of the plant tissues.

A teledermatology care management protocol for tracking completion of teledermatology recommendations.

In July 2009 we implemented a 3-year store-and-forward teledermatology project to provide dermatology care to veterans living in rural and underserved areas of the US Pacific Northwest. We also developed a follow-up protocol and tracking system. Information about all completed teledermatology consultations was entered into a database, and major procedures and select medications were tracked. In the first 21 months, 8202 dermatology conditions in 5232 veterans were treated and 3370 major procedures carried out. Ninety-five percent of conditions were associated with no more than two teledermatology consultations, and no condition required more than ten consultations. In total, 1454 conditions were reviewed for clinical pathological correlation, and in 310 (21%) there was a subsequent clinical pathological correlation conference, resulting in a change in final diagnosis for 93 conditions. The follow-up was important in ensuring high quality patient care.

Spanish validation of the University of Washington Quality of Life questionnaire for head and neck cancer patients.

OBJECTIVE: The University of Washington Quality of Life (UW-QOL) questionnaire is one of the most widely used instruments to evaluate the quality of life of head and neck cancer patients. The aim of this study was to perform a Spanish translation and validation of the UW-QOL questionnaire. STUDY DESIGN: A cross-sectional study. SETTING: Three tertiary-care hospitals and a laryngectomee rehabilitation center. SUBJECTS AND METHODS: The translation and cultural adaptation of the questionnaire were performed following accepted international guidelines. The psychometric validation was performed on a consecutive series of patients treated for squamous cell carcinoma of the upper aerodigestive tract with no signs of relapse, recruited from May 2007 to December 2008. Eligible subjects were invited to complete the Spanish version of the UW-QOL questionnaire during routine clinical consultation, and complete it again within 15 days. Subjects also completed a validated Spanish version of the Goldberg Mental Health Survey and were evaluated by the use of the Karnofsky Index. RESULTS: A Spanish version of the questionnaire was developed in iterative fashion. In the psychometric validation process, a total of 76 patients were analyzed. Reliability was excellent, including both internal consistency (Cronbach's alpha of 0.84) and test-retest reliability (intraclass correlation coefficient between 0.91 and 0.97 with a confidence interval of 95%). Construct validity was supported by statistically significant relationships between the Karnofsky Index, the Goldberg Mental Health Survey, and the translated UW-QOL questionnaire. CONCLUSION: The Spanish version of the UW-QOL questionnaire appears to be culturally appropriate and psychometrically valid.

Influences and predictors of long-term quality of life in head and neck cancer survivors.

OBJECTIVE: To examine the impact of clinical predictors (pretreatment variables) and other influences (treatment and posttreatment variables) on long-term quality of life (QOL) in patients treated for squamous cell carcinoma of the upper aerodigestive tract. We hypothesized that baseline QOL and comorbidity would be predictors of QOL 1 year after treatment. DESIGN: Retrospective cohort study. SETTING: Academic Medical Center in Seattle, Washington. PATIENTS: Patients (N = 173) with baseline (pretreatment) and 1-year posttreatment QOL data. MAIN OUTCOME MEASURE: Head and neck-specific QOL scores at 1 year after treatment (as measured by the University of Washington Quality of Life [UW-QOL] scale). RESULTS: We identified strong relationships between 1-year UW-QOL scores and baseline UW-QOL scores (correlation coefficient [Pearson r] = 0.58; P < .001) and pretreatment comorbidity (as measured by the Adult Comorbidity Evaluation scale) (Spearman rho = 0.23; P < .001). T stage and N stage were also predictive. Although not a predictive variable, the presence of a gastrostomy tube at 1 year also strongly influenced 1-year UW-QOL scores. Patients with gastrostomy tubes had UW-QOL scores 11.5 points worse than those without (P < .001), when a 7-point difference is considered clinically significant. In predictive multivariate regression models, pretreatment QOL scores, comorbidity, and T stage had the strongest prognostic impact on 1-year UW-QOL scores. CONCLUSIONS: In bivariate analyses, the presence of a gastrostomy tube worsens UW-QOL scores at 1 year and requires further investigation. When considering predictive variables only, baseline QOL and comorbidity appear to have strong influences on posttreatment QOL and have greater impact than treatment modality. Greater attention to these baseline predictors should be given when counseling patients about long-term function after treatment.

Brazilian-Portuguese validation of the University of Washington Quality of Life Questionnaire for patients with head and neck cancer.

BACKGROUND: The University of Washington Quality of Life (UW-QOL) questionnaire is an English-language survey instrument used worldwide to assess the quality of life of patients with head and neck cancer. To be used in other cultures, such instruments require careful translation and psychometric validation in other languages. METHODS: The translation and cultural adaptation of the questionnaire were performed following accepted international guidelines. The psychometric validation was performed on a consecutive series of patients with at least 1 year of disease-free survival after treatment for squamous cell carcinoma of the upper aerodigestive tract, recruited from October 2004 to January 2005 from a tertiary cancer center hospital. Eligible subjects were invited to complete the Portuguese version of the UW-QOL questionnaire during routine clinical consultation and complete it again within 15 days. They also completed a validated Portuguese version of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and a questionnaire to evaluate anxiety and depression symptoms (Hospital Anxiety and Depression Scale [HADS]). RESULTS: A Portuguese version of the questionnaire was developed in iterative fashion. In the psychometric validation process, a total of 109 patients were analyzed. Reliability was excellent, including both internal consistency (Cronbach's alpha [alpha] of 0.744) and test retest reliability (intraclass correlation coefficient [ICC] of 0.882). Construct validity was supported by statistically significant relationships between the SF-36 and HAD questionnaires and the translated UW-QOL questionnaire. CONCLUSIONS: The Brazilian-Portuguese version of the UW-QOL questionnaire appears to be culturally appropriate and psychometrically valid. This version is a valuable tool to evaluate accurately the quality of life of Brazilian patients with head and neck cancer.