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Influence of lung volume reduction surgery (LVRS) on health related quality of life in patients with chronic obstructive pulmonary disease
Goldstein RS, Todd TR, Guyatt G, Keshavjee S, Dolmage TE, van Rooy S, Krip B, Maltais F, LeBlanc P, Pakhale S, Waddell TK
Thorax 2003 May;58(5):405-410
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: The clinical value of LVRS has been questioned in the absence of trials comparing it with pulmonary rehabilitation, the prevailing standard of care in COPD. Patients with heterogeneous emphysema are more likely to benefit from volume reduction than those with homogeneous disease. Disease specific quality of life is a responsive interpretable outcome that enables health professionals to identify the magnitude of the effect of an intervention across several domains. METHODS: Non-smoking patients aged < 75 years with severe COPD (FEV1 < 40% predicted, FEV1/FVC < 0.7), hyperinflation, and evidence of heterogeneity were randomised to surgical or control groups after pulmonary rehabilitation and monitored at 3 month intervals for 12 months with no crossover between the groups. The primary outcome was disease specific quality of life as measured by the Chronic Respiratory Questionnaire (CRQ). Treatment failure was defined as death or functional decline (fall of 1 unit in any two domains of the CRQ). Secondary outcomes included pulmonary function and exercise capacity. RESULTS: LVRS resulted in significant between group differences in each domain of the CRQ at 12 months (change of 0.5 represents a small but important difference): dyspnoea 1.9 (95% confidence interval (CI) 1.3 to 2.6; p < 0.0001); emotional function 1.5 (95% CI 0.9 to 2.1; p < 0.0001); fatigue 2.0 (95% CI 1.4 to 2.6; p < 0.0001); mastery 1.8 (95% CI 1.2 to 2.5; p < 0.0001). In the control group one of 27 patients died and 16 experienced functional decline over 12 months. In the surgical group four of 28 patients died and three experienced functional decline (hazard ratio = 3.1 (95% CI 1.3 to 7.6; p = 0.01). Between group improvements (p < 0.05) in lung volumes, flow rates, and exercise were sustained at 12 months (RV -47% predicted (95% CI -71 to -23; p = 0.0002); FEV1 0.3 l (95% CI 0.1 to 0.5; p = 0.0003); submaximal exercise 7.3 min (95% CI 3.9 to 10.8; p < 0.0001); 6 minute walk 66 metres (95% CI 32 to 101; p = 0.0002). CONCLUSIONS: In COPD patients with heterogeneous emphysema, LVRS resulted in important benefits in disease specific quality of life compared with medical management, which were sustained at 12 months after treatment.
Reproduced with permission from the BMJ Publishing Group.

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