Research O ver the past decade, several initiatives have been established to attempt to improve end-of-life care. 1-3Quality of life for terminally ill patients, 4,5 quality of death and dying 6,7 and quality care at the end of life 8 are related concepts that have been evaluated in these efforts to improve end-of-life care. Quality of care at the end of life is distinguished from quality of life and of death by its focus on the optimization of care and satisfaction with care, clearly linking quality measurement and quality improvement. 6,9Unfortunately, initiatives to improve satisfaction with endof-life care remain hampered by our nascent understanding of what quality care means to patients and their families, and how it is best measured.9-11 Several experts and professional societies have attempted to define the specific components and related areas (domains) involved in quality end-of-life care;12-16 in contrast, patient and family perspectives are surprisingly lacking.Most previous studies of quality have focused on outpatients and people with cancer.17-21 We recently documented that most Canadians (> 70%) die in hospitals, and the majority of decedents are elderly patients who died from causes unrelated to cancer.22,23 The trajectory of a patient dying from cancer differs from one dying from other, chronic, end-stage medical conditions.24 Thus, issues deemed important to quality end-of-life care that were identified by previous investigators may not be generalizable to seriously ill patients with advanced disease other than cancer, who have a more uncertain prognosis.The primary purpose of this study was to describe what seriously ill patients admitted to hospital and their family members consider the key elements of quality end-of-life care. Our secondary objectives included exploring whether differences in ratings of importance exist between patient and caregiver subgroups and between patients and family members. MethodsWe designed a cross-sectional survey to be conducted at 5 tertiary care teaching hospitals across Canada. From west to east, they were St. Paul's Hospital, Vancouver, BC; Royal Alexandra Hospital, Edmonton, Alta.; Toronto General Hospital, Toronto, and Kingston General Hospital, Kingston, Ont.; and Queen Elizabeth II Health Sciences Centre, Halifax, NS.
Changes in lung hyperinflation, dyspnea, and exercise endurance are important outcomes in assessing therapeutic responses in chronic obstructive pulmonary disease (COPD). Therefore, we studied the reproducibility of Borg dyspnea ratings, inspiratory capacity (IC; to monitor lung hyperinflation), and endurance time during constant-load symptom-limited cycle exercise in 29 patients with COPD (FEV1 = 40 +/- 2% predicted; mean +/- SEM). Responsiveness was also studied by determining the acute effects of nebulized 500 micrograms ipratropium bromide (IB) or saline placebo (P) on these measurements. During each of four visits conducted over an 8-wk period, spirometry and exercise testing were performed before and 1 h after receiving IB or P (randomized, double-blinded). Highly reproducible measurements included: endurance time (intraclass correlation R = 0.77, p < 0.0001); Borg ratings and IC at rest, at a standardized exercise time (STD), and at peak exercise (R > 0.6, p < 0.0001); and slopes of Borg ratings over time, oxygen consumption (V O2), and ventilation (R > 0.6, p < 0.0001). Responsiveness was confirmed by finding a significant drug effect for: change (Delta) in endurance time (p = 0.0001); DeltaBorgSTD and DeltaBorg-time slopes (p < 0.05); and DeltaIC at rest, at STD, and at peak exercise (p = 0.0001). With all completed visits, DeltaBorgSTD correlated better with DeltaICSTD than any other resting or exercise parameter (n = 115, r = -0.35, p < 0.001). We concluded that Borg dyspnea ratings, and measurements of IC and endurance time during submaximal cycle exercise testing are highly reproducible and responsive to change in severe COPD.
Background: Controlled clinical trials of health care interventions are either explanatory or pragmatic. Explanatory trials test whether an intervention is efficacious; that is, whether it can have a beneficial effect in an ideal situation. Pragmatic trials measure effectiveness; they measure the degree of beneficial effect in real clinical practice. In pragmatic trials, a balance between external validity (generalizability of the results) and internal validity (reliability or accuracy of the results) needs to be achieved. The explanatory trial seeks to maximize the internal validity by assuring rigorous control of all variables other than the intervention. The pragmatic trial seeks to maximize external validity to ensure that the results can be generalized. However the danger of pragmatic trials is that internal validity may be overly compromised in the effort to ensure generalizability. We are conducting two pragmatic randomized controlled trials on interventions in the management of hypertension in primary care. We describe the design of the trials and the steps taken to deal with the competing demands of external and internal validity.
We wished to determine which resting spirometric parameters best reflect improvements in exercise tolerance and exertional dyspnea in response to acute high-dose anticholinergic therapy in advanced COPD. We studied 29 patients with stable COPD (FEV(1) = 40 +/- 2% predicted [%pred]; mean +/- SEM) and moderate to severe chronic dyspnea. In a double-blind placebo-controlled cross-over study, patients performed spirometry and symptom-limited constant-load cycle exercise before and 1 h after receiving 500 micrograms of nebulized ipratropium bromide (IB) or saline placebo. There were no significant changes in spirometry, exercise endurance, or exertional dyspnea after receiving placebo. In response to IB (n = 58): FEV(1), FVC, and inspiratory capacity (IC) increased by 7 +/- 1%pred, 10 +/- 1%pred, and 14 +/- 2%pred, respectively (p < 0.001), with no change in the FEV(1)/FVC ratio. After receiving IB, exercise endurance time (Tlim) increased by 32 +/- 9% (p < 0.001) and slopes of Borg dyspnea ratings over time decreased by 11 +/- 6% (p < 0.05). Percent change (%Delta) in Tlim correlated best with DeltaIC%pred (p = 0.020) and change in inspiratory reserve volume (DeltaTLC%pred) (p = 0.014), but not with DeltaFVC%pred, DeltaPEFR%pred, or DeltaFEV(1)%pred. Change in Borg dyspnea ratings at isotime near end exercise also correlated with DeltaIC%pred (p = 0.04), but not with any other resting parameter. Changes in spirometric measurements are generally poor predictors of clinical improvement in response to bronchodilators in COPD. Of the available parameters, increased IC, which is an index of reduced resting lung hyperinflation, best reflected the improvements in exercise endurance and dyspnea after IB. IC should be used in conjunction with FEV(1) when evaluating therapeutic responses in COPD.
clinicaltrials.gov Identifier: NCT00520858.
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