Quality of randomised trials in COPD. Effects of psychotherapy in moderately severe COPD: a pilot study. Can small group education and peer review improve care for patients with asthma/chronic obstructive pulmonary disease?
Randomised trials can provide high-level evidence to inform treatment decisions. Since their quality in respiratory medicine is largely unknown, we assessed the quality of a large set of chronic obstructive pulmonary disease (COPD) trials. As a marker of trial quality, we assessed the procedure and concealment of random allocation, and the conduct of an intention-to-treat-analysis in 344 randomised trials published between 1957 and 2006. We used ordered logistic regression to assess the association between trial quality and type of intervention, type of journal, journal impact factor and year of publication. 257 (75%) trials assessed pharmacological and 87 (25%) assessed nonpharmacological interventions. The generation of appropriate randomisation was reported in 27.0% of the trials, concealment of random allocation in 11.6% and an intention-to-treat analysis in 21.8% of trials. Significantly higher quality was found in trials on nonpharmacological interventions (OR 2.49, 95% CI 1.56-3.99), and in trials published in general medical journals (versus specialised journals; OR 2.25, 95% CI 1.30-3.90) and after 2000 (versus 1957-2000; OR 2.28, 95% CI 1.45-3.58). The association of quality with a high impact factor was of borderline significance (p = 0.06). The quality of many COPD trials is low but tends to become better since the adoption of the CONSORT (Consolidated Standards of Reporting Trials) statement. Anxiety is common in the "pink puffer" syndrome associated with chronic obstructive pulmonary disease (COPD). The degree of anxiety correlates well with perceived dyspnoea. This pilot study examines the effect of group psychotherapy on anxiety, exercise tolerance, dyspnoea and quality of life. Ten patients with moderately severe, stable COPD (mean forced expiratory volume in one second (FEV1)-1.15 L) had six 90 min sessions of cognitive and behavioural psychotherapy at weekly intervals. Patients completed the Hospital Anxiety and Depression Scale (HADS), Medical Research Council Questionnaire (MRCQ) and St George's Respiratory Questionnaires (SGRQ), 1 week before and after therapy. FEV1, forced vital capacity (FVC), slow vital capacity (SVC), blood gas tensions and 6 min walking distance (6MWD) were measured. Eight control patients attended weekly for lung function and 6MWD for 6 weeks, but had no psychotherapy. Mean baseline HADS score was significantly higher in the psychotherapy group (12) than in controls (7), but otherwise there were no differences in lung function, blood gas tensions, 6MWD, or the other questionnaire scores between groups. After treatment, the physiological and psychological parameters where unchanged in both groups with the exception of the mean 6MWD, which had improved in the psychotherapy group only, from 351 to 423 m (p<0.001), an increase of 24%. Three months after treatment, the 6MWD was still 16% above the baseline value (p=0.02). In conclusion, six sessions of cognitive and behavioural psychotherapy produced a sustained improvement in exercise tolerance in a group of 10 anxious patients with severe chronic obstructive pulmonary disease, without any change in anxiety scores on the Hospital Anxiety and Depression Scale. Further studies of more prolonged, intensive psychotherapy would establish whether better symptom and quality of life scores accompany more dramatic increases in exercise tolerance in "pink puffers". To study the effectiveness of an intensive small group education and peer review programme aimed at implementing national guidelines on asthma/chronic obstructive pulmonary disease (COPD) on care provision by general practitioners (GPs) and on patient outcomes.
                A randomised experimental study with pre-measurement and post-measurement (after one year) in an experimental group and a control group in Dutch general practice.
                Two groups of GPs were formed and randomised. The education and peer review group (17 GPs with 210 patients) had an intervention consisting of an interactive group education and peer review programme (four sessions each lasting two hours). The control group consisted of 17 GPs with 223 patients (no intervention).
                Knowledge, skills, opinion about asthma and COPD care, presence of equipment in practice; actual performance about peakflow measurement, non-pharmacological and pharmacological treatment; asthma symptoms (Dutch Medical Research Council), smoking habits, exacerbation ratio, and disease specific quality of life (QOL-RIQ). Data were collected by a written questionnaire for GPs, by self recording of consultations by GPs, and by a written self administered questionnaire for adult patients with asthma/COPD.
                Data from 34 GP questionnaires, 433 patient questionnaires, and recordings from 934 consultations/visits and 350 repeat prescriptions were available. Compared with the control group there were only significant changes for self estimated skills (+16%, 95% confidence interval 4% to 26%) and presence of peakflow meters in practice (+18%, p < 0.05). No significant changes were found for provided care and patient outcomes compared with the control group. In the subgroup of more severe patients, the group of older patients, and in the group of patients not using anti-inflammatory medication at baseline, no significant changes compared with the control group were seen in patient outcomes.
                Except for two aspects, intensive small group education and peer review in asthma and COPD care do not seem to be effective in changing relevant aspects of the provided care by GPs in accordance with guidelines, nor in changing patients' health status.
Due to the sub-optimal quality of the trials and statistically non-significant results, it is not possible to draw any conclusions for treatment. This review highlights the paucity of data in this area. As such, there is a need for scientifically rigorous research trials to evaluate the role of pharmacological interventions for anxiety disorders in patients with COPD, using a sample size large enough to demonstrate meaningful clinical significance.