Assessing Education in Pulmonary Rehabilitation: The Understanding COPD (UCOPD) Questionnaire

Abstract

There is currently no questionnaire available that comprehensively assesses patients’ understanding, self-efficacy and satisfaction with the education component of pulmonary rehabilitation. The aim of this study was to develop the Understanding COPD (UCOPD) questionnaire. The key stages in the development of the UCOPD questionnaire were: (i) Generation of questions, and assessment of face and content validity, user-centredness, acceptability and feasibility; (ii) Assessment of plain English and readability; (iii) Assessment of structural validity; (iv) Assessment of test-retest reliability and internal consistency; (v) Assessment of the responsiveness, convergent validity and floor and ceiling effects. The UCOPD questionnaire assesses understanding, self-efficacy and use of key self-management skills (Section A) and satisfaction (Section B). It has good validity and practical properties, and readability was acceptable. It has good test-retest reliability (Section A: ICC range: 0.87 to 0.96; Section B: Wilcoxon: p > 0.05) and internal consistency (Cronbach's Alpha range: 0.78 to 0.95). It is responsive to pulmonary rehabilitation (Mean change: About COPD: 18.26 [12.12 to 24.40]%, Managing Symptoms 20.94 [13.86 to 28.01]%, Accessing Help and Support 24.06 [14.53 to 33.60]%, Total 20.59 [14.43 to 26.75]%, p < 0.001). It had a moderate correlation with the Bristol COPD Knowledge Questionnaire (BCKQ): pre-pulmonary rehabilitation: r = 0.41, p = 0.02; post-pulmonary rehabilitation: r = 0.35, p = 0.047. In conclusion, the UCOPD questionnaire offers the opportunity to assess the benefit of the education component of pulmonary rehabilitation in terms of its effect on understanding, self-efficacy and satisfaction. Further research is needed across different pulmonary rehabilitation settings to demonstrate the robustness of the UCOPD questionnaire, and to establish the minimum clinically important difference.     

Assessment of the Anti-Aging Klotho Protein in Patients with COPD Undergoing Pulmonary Rehabilitation

Chronic obstructive pulmonary disease (COPD) is associated with the accelerated aging of the lung. The protein klotho has been implicated in longevity, and there is some evidence that it might be involved in the pathomechanism of chronic respiratory diseases. Therefore, we aimed to examine whether the clinical condition of COPD patients is reflected in plasma klotho concentration. As plasma concentration of the protein is modulated by physiological factors that are generally improved during pulmonary rehabilitation, we hypothesized that a complex rehabilitation program may alter plasma klotho concentration. Blood samples were taken from 31 stable COPD patients. Clinical parameters such as respiratory function, 6-minute walking distance (6MWD), impact of disease (CAT), dyspnea, grip strength, chest expansion and breath holding time, smoking history, and body mass index (BMI) were evaluated. 19 patients who participated in a 3-week inpatient rehabilitation program had blood sample collection on the first, third, and last days of the program and had the above functional measurements before and after rehabilitation. Plasma klotho concentration was assessed by enzyme-linked immunosorbent assay. Klotho levels showed no correlation with clinical parameters (FEV1%, 6MWD, grip strength, CAT, smoking history, p > 0.05). Coefficient of variation of klotho measurements was 4.5% between Day 1 and Day 3. Although the rehabilitation resulted in significant improvements in 6MWD, CAT, grip strength, and chest expansion, klotho levels did not change significantly (510.1 ± 149.9 vs. 504.2 ± 139.8 pg/ml, p > 0.05). Plasma klotho concentration can be reliably measured in stable COPD; however, its levels are not correlated with clinical parameters of patients. Despite functional improvement, klotho level remains unchanged during the rehabilitation program.     

The Impact of Pulmonary Rehabilitation on Chronic Pain in People with COPD

Abstract

Chronic pain affects up to 88% of people with chronic obstructive pulmonary disease (COPD) and has been associated with comorbidities. However, with pain not evaluated during pulmonary rehabilitation (PR) assessments, it is unclear whether PR impacts pain intensity and coping ability. This study aimed to 1) determine the effect of PR on pain qualities, coping behavior and psychological symptoms in those with COPD and chronic pain; and 2) assess the impact of PR on exercise capacity and quality of life in individuals with COPD and chronic pain compared to those without pain. Patients with COPD and comorbidities enrolling in outpatient PR were assessed for chronic pain. Those with chronic pain completed the Brief Pain Inventory, Coping Strategies Questionnaire-24, Fear Avoidance Behavior Questionnaire and measures of anxiety and depression. Changes in HRQOL and 6-minute walk distance (6MWD) following PR were compared between participants with and without chronic pain. Thirty-four participants with chronic pain and 34 participants without pain were included (mean?±?SD, FEV₁ 47?±?19% predicted). In those with chronic pain, PR did not affect pain intensity (median[IQR] pre/post PR 3[2–5] vs. 4[2–6] points, p?=?0.21), anxiety (7[2–9] vs. 5[3–8] points, p?=?0.82) or depression (4[2–8] vs. 3[1–6] points, p?=?0.38) and did not change pain coping strategies. Both groups improved in 6MWD (mean difference [95% CI] 17[?39 to 72] m), and those without pain had greater improvement in mastery (p?=?0.013). PR was effective in patients with moderate to severe COPD whether or not they reported chronic pain at the time of their initial assessment.     

Outcomes of Pulmonary Rehabilitation for COPD in Older Patients: A Comparative Study

Pulmonary rehabilitation (PR) is established as an effective intervention in optimising function and quality of life in patients with chronic obstructive pulmonary disease (COPD). However, there are very limited data on the effectiveness of PR in older patients with COPD. We reviewed all patients attending an 8-week outpatient programme. Patients were divided into two groups; Group A (n = 202), below 70 years, and Group B (n = 122), above 70 years of age. Outcomes in both patient subgroups were compared using FEV¹, Incremental Shuttle Walk Test (ISWT), Endurance Shuttle Walk Test (ESWT), Grip Strength, St. George's Respiratory Questionnaire (SGRQ), Hospital Anxiety and Depression Score (HADS), and COPD Assessment Test (CAT) score. Statistical analysis was conducted using Mann-Whitney non-parametric testing and chi-square testing for comparison of clinically relevant improvements between groups. There was no significant difference in PR outcomes between Group A and Group B using absolute values. Mean changes in ISWT for Groups A and B 39.7 m vs. 32.8 m (p = 0.63), respectively, SGRQ ?2.5 vs. ?2.8 (p = 0.95), HADS anxiety score ?0.83 vs. ?0.57 (p = 0.43) and HADS depression score ?0.69 vs. ?0.39 (p = 0.48), respectively. There was no difference in the proportion of patients who achieved the minimal clinically significant improvement in Group A versus Group B for parameters ISWT (38.6% vs 42.7%), SGRQ (27.8% vs 21.3%), and HADS total score (20.5% vs 28.1%). These data suggest that benefits of PR in COPD are not age dependent. Age should not be a barrier to enrolling patients with COPD in PR programmes.     

Effects of 3-week Outpatient Pulmonary Rehabilitation on Exercise Capacity, Dyspnea, and Quality of Life in COPD

The effects of intensive 3-week outpatient pulmonary rehabilitation (PR) on exercise capacity, dyspnea, and health-related quality of life (HRQL) were investigated in patients with COPD. Two hundred ten patients with COPD (mean FEV₁ = 54%pred) underwent PR consisting of exercise training, patient and psychosocial education, breathing and relaxation therapy, nutrition counseling, and smoking cessation support. Before and after PR, exercise capacity was assessed with 6-min walking tests (6MWT) and constant cycle ergometer exercise (CEE). Dyspnea was measured after 6MWTs with a Borg scale and after PR with the Transition Dyspnoea Index (TDI). HRQL was examined with the Medical Outcomes Study Short Form 36 (SF-36). Results showed improvements in the 6MWT (+39 m, p < 0.001) and CEE (+241 W × min, p < 0.001) after PR, paralleled by decreased dyspnea during the 6MWT (−0.5, p < 0.001) and during activities (TDI score = 3.6). Increases in all SF-36 subscales reflected improved HRQL after PR (p < 0.001). No gender differences were found. Patients with milder versus more severe COPD improved similarly in most outcomes. Regression analyses revealed that TDI scores were the most important predictor of improvements in HRQL. The results suggest that intensive 3-week outpatient PR is associated with improvements in exercise capacity, dyspnea, and HRQL in male and female patients with COPD irrespective of COPD severity. Reduced dyspnea during activities contributed the most to improvements in HRQL.     

Distinct Trajectories of Physical Activity Among Patients with COPD During and After Pulmonary Rehabilitation

Little is known about longitudinal trends in objectively measured physical activity (PA) during and after pulmonary rehabilitation (PR) for individuals with Chronic Obstructive Pulmonary Disease (COPD). The purpose of this study was to examine the PA trajectories of patients with COPD during and after PR and whether demographic, clinical, or program characteristics differed across these trajectories. The study was approved by Research Ethics Boards at all participating institutions, and written informed consent was obtained from each participant prior to study inclusion. COPD patients (N = 190) completed a questionnaire and wore a pedometer for 7 days at baseline, end of PR, and 3 and 9 months after completing PR. Latent class growth analyses showed that two distinct PA trajectories emerged. Active Maintainers averaged 9177 steps/day at baseline, and maintained this level throughout the assessment and post rehabilitation period. In contrast, Inactive Maintainers averaged 3133 steps/day at baseline, which also remained stable during and after PR. Follow-up analyses showed the Inactive Maintainers were more likely to be retired from work and have lower baseline scores for their stress tests and 6-minute walk tests compared to Active Maintainers (all p < 0.05). These results suggest that two distinct steps/day trajectories exist for COPD patients during and after completing PR that are partially explained by specific demographic and clinical characteristics.     

Impact of severe haemophilia A on patients' health status: results from the guardian™ 1 clinical trial of turoctocog alfa (NovoEight®)

Haemophilia and its treatment interfere with patients' life and may affect adherence to treatment. This study explored the impact of severe haemophilia A on patients' health status, especially in young adults (YA), using data from guardian^? 1, a multinational, open‐label, non‐controlled phase 3 trial investigating safety and efficacy of turoctocog alfa (NovoEight^®) in previously treated patients aged 12 years and older with severe haemophilia A (FVIII ≤ 1%). Health status was assessed using the EuroQoL‐5 dimensions (EQ‐5D‐3L), covering 5 dimensions of health (mobility, self‐care, usual activities, pain/discomfort and anxiety/depression), and a visual analogue scale (VAS) measuring self‐rated overall health status. EQ‐5D was administered pretreatment (screening/baseline) and posttreatment (end‐of‐trial). Baseline responses to the EQ‐5D dimensions and VAS were described overall and by age and compared to reference values from UK general population. Guardian^? 1 included 150 patients (16 adolescents, 83 YA aged 16–29 and 51 adults aged 30+). All five dimensions of patients' health status were impacted at baseline. The percentage of haemophilia patients reporting problems was consistently significantly greater than age‐matched general population reference values. Likewise, for all age groups mean baseline EQ‐5D VAS score was significantly lower for haemophilia patients (YA: 78.0) than for the general population (YA aged 18–29: 87.3). The health status of patients with severe haemophilia A entering guardian^? 1 was markedly poorer than that of the general population, particularly regarding mobility and pain. YA patients reported better health status than older patients, but considerably lower than that of the general YA population.     

Validation of the i-BODE Index as a Predictor of hospitalization and Mortality in Patients with COPD Participating in Pulmonary Rehabilitation

The aim of this study was to examine the value of the i-BODE index to predict hospital admission and to confirm its usefulness to predict mortality in a Danish population. The incremental shuttle walking test (ISWT) is widely used in the UK and Europe and previous work has examined the replacement of the 6MWT with the ISWT within the BODE index for predicting the prognosis of COPD (i-BODE). The 674 patients included in the analysis participated in a 7-week pulmonary rehabilitation program from 2002 to 2011. The National Health Services Central Register ascertained vital status and provided information on all hospital admissions. The mean follow-up period was 66 months (range 11–118 months). Cox proportional hazards model was used to identify factors that significantly predicted mortality and time to first hospital admission.

The i-BODE index as well as body mass index, MRC dyspnea grade, and exercise capacity (ISWT) were significantly associated with all-cause mortality. The adjusted hazard ratio for death per one point increase in the i-BODE score was 1.28 (95% confidence interval 1.20 to 1.37). The i-BODE index was also a significant predictor of hospitalization, both for all causes and COPD exacerbation. Patients in the highest i-BODE quartile had a median time to first hospitalization of 17 months compared to 51 months for patients in the lowest quartile. The i-BODE index is a significant predictor of hospital admission and thus health care utilization, and also mortality.     

A Comparison of Pain,Fatigue, Dyspnea and their Impact on Quality of Life in Pulmonary Rehabilitation Participants with Chronic Obstructive Pulmonary Disease

In addition to dyspnea and fatigue, pain is a prevalent symptom in chronic obstructive pulmonary disease (COPD). Understanding the relative prevalence, magnitude, and interference with aspects of daily living of these symptoms can improve COPD management. Therefore, the purposes of this study were to: (1) compare the prevalence and magnitude of dyspnea, fatigue, and pain and how each limits aspects of daily living; (2) determine the association between pain and the other two symptoms; and (3) assess the impact of these symptoms on quality of life in COPD. Participants were recruited from pulmonary rehabilitation programs. Pain, dyspnea, and fatigue were measured using the Brief Pain Inventory (BPI), Brief Fatigue Inventory (BFI), and Dyspnea Inventory (DI), respectively. Quality of life was measured using the Clinical COPD Questionnaire (CCQ). The prevalence of dyspnea, fatigue, and pain were 93%, 77%, and 74%, respectively. Individuals with COPD reported similar severity scores of the three symptoms. Dyspnea interfered with general activity more than pain (F_1.7,79.9 = 3.1, p < 0.05), whilst pain interfered with mood (F_{1.8, 82.7} = 3.6, p < 0.05) and sleep (F_1,46 = 7.4, p < 0.01) more than dyspnea and fatigue. These three symptoms were moderately-to-highly correlated with each other (ρ = 0.49–0.78, p < 0.01) and all individually impacted quality of life. In summary, pain is a common symptom in addition to dyspnea and fatigue in COPD; all three interfere similarly among aspects of daily living with some exceptions. Accordingly, management of COPD should include a multifaceted approach that addresses pain as well as dyspnea and fatigue.     

Comparison of the COPD Assessment Test (CAT) and the Clinical COPD Questionnaire (CCQ) in a Clinical Population

Introduction: The COPD Assessment Test (CAT) and the Clinical COPD Questionnaire (CCQ) are both clinically useful health status instruments. The main objective was to compare CAT and CCQ measurement instruments. Methods: CAT and CCQ forms were completed by 432 randomly selected primary and secondary care patients with a COPD diagnosis. Correlation and linear regression analyses of CAT and CCQ were performed. Standardised scores were created for the CAT and CCQ scores, and separate multiple linear regression analyses for CAT and CCQ examined associations with sex, age (≤ 60, 61–70 and >70 years), exacerbations (≥1 vs 0 in the previous year), body mass index (BMI), heart disease, anxiety/depression and lung function (subgroup with n = 246). Results: CAT and CCQ correlated well (r = 0.88, p < 0.0001), as did CAT ≥ 10 and CCQ ≥ 1 (r = 0.78, p < 0.0001). CCQ 1.0 corresponded to CAT 9.93 and CAT 10 to CCQ 1.29. Both instruments were associated with BMI < 20 (standardised adjusted regression coefficient (95%CI) for CAT 0.56 (0.18 to 0.93) and CCQ 0.56 (0.20 to 0.92)), exacerbations (CAT 0.77 (0.58 to 0.95) and CCQ 0.94 (0.76 to 1.12)), heart disease (CAT 0.38 (0.17 to 0.59) and CCQ 0.23 (0.03 to 0.43)), anxiety/depression (CAT 0.35 (0.15 to 0.56) and CCQ 0.41 (0.21 to 0.60)) and COPD stage (CAT 0.19 (0.05 to 0.34) and CCQ 0.22 (0.07 to 0.36)). Conclusions: CAT and CCQ correlate well with each other. Heart disease, anxiety/depression, underweight, exacerbations, and low lung function are associated with worse health status assessed by both instruments.     

Detecting Improvements in Dyspnea in COPD Using a Three-Minute Constant Rate Shuttle Walking Protocol

Abstract

Rationale: We examined the responsiveness of a 3-minute constant rate shuttle walking protocol to detect improvements in exertional dyspnea following acute bronchodilation in COPD. Our hypothesis was that the 3-minute constant rate shuttle walking protocol would be able to adequately put forth improvements in exertional dyspnea following acute bronchodilation in this population. Methods: Using a placebo controlled, double-blind cross-over design, 39 patients with moderate to severe COPD performed a 3-min constant rate shuttle walking test during which they were asked to walk on a flat corridor at a speed that was externally imposed by an audio signal. During the test, dyspnea was graded using the 10-point modified Borg scale. The test was performed twice, following the administration of saline placebo or of 500 μg nebulized ipratropium bromide. Results: Improvements of respiratory pattern (respiratory rate and tidal volume) and statistically and clinically significant reductions in Borg dyspnea scores (? dyspnea score = 1.0 ± 0.2, p < 0.01) were seen during the 3-min shuttle walking protocol with ipratropium bromide compared to placebo. Conclusion: This 3-minute shuttle walking protocol adequately detected dyspnea and breathing pattern improvements following acute bronchodilation in COPD.     

Prevalence of Asthma among German Adults: Analysis of the German National Telephone Survey

Health-related quality-of-life scores depend on patients' judgments about their condition and its effect on them. Asthma is a long-term disease, and it is possible that patients may learn to accept some of its effects. We tested the hypothesis that patients come to accept some asthma effects and then discount them as being important when rating their health. We asked patients which of the asthma effects listed in the St. George's Respiratory Questionnaire were acceptable to them. This enabled us to calculate a score for effects of asthma that patients experienced, yet were acceptable to them. The comparative validity of the Current, Acceptable and Unacceptable St George's Respiratory Questionnaire scores was examined by testing their correlations with a variety of asthma-related variables. Eighty patients participated, mean age 50 years, mean forced expiratory volume in 1 second (FEV₁) 73 (SD 24)% predicted. Acceptability of St George's Respiratory Questionnaire items was related to the previously identified severity weights (rho = ?0.65, p < 0.0001), but some severe effects were acceptable to some patients. Patients who accepted higher levels of health impairment were older with more severe disease. Unacceptable health was less well correlated with asthma-related variables than was current health. We conclude that patients accept some asthma effects but do not appear to discount them when using a detailed health status questionnaire.     

Clinical Impact of Time of Day on Acute Exercise Response in COPD

The purpose of this pilot study was to determine the impact of time of day on the acute response to incremental exercise in chronic obstructive pulmonary disease (COPD). Fourteen subjects (nine men) aged 71 ± 7 years with moderate to severe airflow obstruction (FEV₁: 58 ± 13% predicted) followed a counterbalanced randomized design, performing three symptom-limited incremental cycling tests at 8:00, 12:00, and 16:00 hours on different days, each preceded by a spirometry. COPD medications were withdrawn prior to testing. No overall time effect was found for peak exercise capacity (p = 0.22) or pulmonary function (FEV₁, p = 0.56; FVC, p = 0.79). However, a large effect size (f = 0.48) was observed for peak exercise capacity and several pulmonary function parameters. For peak exercise capacity, the average within-subject coefficient of variation was 5.5 ± 3.9% and the average amplitude of change was 7 ± 5W. Seven subjects (50%) showed diurnal changes at levels equal to or beyond the minimal clinically important difference for both peak exercise capacity and pulmonary function. In this sub-group, peak exercise capacity was greatest at 16:00 hours (p = 0.03, ? = 1.04). No systematic time-of-day effect on peak exercise capacity was obtained in COPD patients in the present pilot study. However, based on the observed effect size and on the average amplitude of change and within-subject variations seen across testing times, the guidelines recommendation that time of day be standardized for repeat exercise testing in COPD should be maintained.     

Impact of health literacy on socioeconomic and racial differences in health in an elderly population

BACKGROUND: Differences in health literacy levels by race and education are widely hypothesized to contribute to health disparities, but there is little direct evidence. OBJECTIVE: To examine the extent to which low health literacy exacerbates differences between racial and socioeconomic groups in terms of health status and receipt of vaccinations. DESIGN: Retrospective cohort study. PARTICIPANTS (OR PATIENTS OR SUBJECTS): Three thousand two hundred and sixty noninstitutionalized elderly persons enrolling in a Medicare managed care plan in 1997 in Cleveland, OH; Houston, TX; South Florida; and Tampa, FL. MEASUREMENTS: Dependent variables were physical health SF-12 score, mental health SF-12 score, self-reported health status, receipt of influenza vaccine, and receipt of pneumococcal vaccine. Independent variables included health literacy, educational attainment, race, income, age, sex, chronic health conditions, and smoking status. RESULTS: After adjusting for demographic and health-related variables, individuals without a high school education had worse physical and mental health and worse self-reported health status than those with a high school degree. Accounting for health literacy reduced these differences by 22% to 41%. Black individuals had worse self-reported health status and lower influenza and pneumococcal vaccination rates. Accounting for health literacy reduced the observed difference in self-reported health by 25% but did not affect differences in vaccination rates. CONCLUSIONS: We found that health literacy explained a small to moderate fraction of the differences in health status and, to a lesser degree, receipt of vaccinations that would normally be attributed to educational attainment and/or race if literacy was not considered.     

One-Year Extension Study of ACCORD COPD I: Safety and Efficacy of Two Doses of Twice-daily Aclidinium Bromide in Patients with COPD

Abstract

This was a 52-week, double-blind, extension study in which COPD patients previously treated with twice-daily (BID) aclidinium bromide 200 μg or 400 μg during a 12-week lead-in study (ACCORD COPD I) continued the same treatment, while patients previously receiving placebo were rerandomized (1:1) to aclidinium 200 μg or 400 μg BID. The primary objective of this study was to evaluate the long-term safety and tolerability of aclidinium treatment. Efficacy outcomes included bronchodilation, health status, and rescue medication use. A total of 467 patients completed the lead-in study and 291 patients consented to participate in the extension. At study end, the percentages of patients who reported a treatment-emergent adverse event (TEAE) were similar for both treatments (200 μg, 77.4%; 400 μg, 73.7%). Incidence of anticholinergic TEAEs was low and similar for both treatments, with dry mouth reported in only 1 patient (400 μg). Cardiac TEAEs were reported by a similarly low percentage of patients (<5% for any event in any group) with no apparent dose dependence. Improvements from baseline in lung function were greatest for patients who received continuous aclidinium treatment and those who were rerandomized from placebo to aclidinium 400 μg; these improvements were generally sustained throughout the study. Health status and overall rescue medication use was improved from baseline for both treatments. The safety profile of twice-daily aclidinium and sustained improvements in lung function and health status throughout the 52-week extension study support its use as a long-term maintenance treatment for patients with COPD. (Clinical trial registration number NCT00970268).