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E-pneumo.frCite this article as: BMJ, doi:10.1136/bmj.38258.662720.3A (published 25 October 2004)
Community pulmonary rehabilitation after hospitalisation for acute
exacerbations of chronic obstructive pulmonary disease: randomised
William D-C Man, Michael I Polkey, Nora Donaldson, Barry J Gray, John Moxham
NHS) but also to real improvements in quality of life andfunctional ability in breathless and vulnerable patients with Objective To evaluate the effects of an early community based
pulmonary rehabilitation programme after hospitalisation for Pulmonary rehabilitation is a multidisciplinary programme acute exacerbations of chronic obstructive pulmonary disease of care for patients with chronic respiratory impairment that is individually tailored and designed to optimise each patient’s Design A single centre, randomised controlled trial.
physical and social performance and autonomy. Pulmonary Setting An inner city, secondary and tertiary care hospital in
rehabilitation leads to statistically significant and clinically mean- ingful improvements in health related quality of life, functional Participants 42 patients admitted with an acute exacerbation of
exercise capacity, and maximum exercise capacity in patients with stable COPD.3 4 Consequently, the recent guidelines on the Intervention An eight week, pulmonary rehabilitation
management of COPD published by the National Institute for programme for outpatients, started within 10 days of hospital Clinical Excellence (NICE) and the British Thoracic Society rec- ommend that pulmonary rehabilitation should be made Main outcome measures Incremental shuttle walk distance,
available to all appropriate patients.5 However, the effects of early disease specific health status (St George’s respiratory pulmonary rehabilitation of outpatients in the acute recovery questionnaire, SGRQ; chronic respiratory questionnaire, CRQ) phase after hospital admission for acute exacerbations of COPD and generic health status (medical outcomes short form 36 have not previously been studied. Patients are particularly questionnaire, SF-36) at three months after hospital discharge.
vulnerable after a hospital admission, and we assumed that early Results Early pulmonary rehabilitation, compared with usual
pulmonary rehabilitation of outpatients would lead to notable care, led to significant improvements in median incremental improvements in exercise capacity and health status, as it does in shuttle walk distance (60 metres, 95% confidence interval 26.6 metres to 93.4 metres, P = 0.0002), mean SGRQ total score We assessed the feasibility and safety of an early pulmonary ( − 12.7, − 5.0 to − 20.3, P = 0.002), all four domains of the CRQ rehabilitation programme for outpatients and determined the (dyspnoea 5.5, 2.0 to 9.0, P = 0.003; fatigue 5.3, 1.9 to 8.8, effects on exercise capacity and quality of life, compared with P = 0.004; emotion 8.7, 2.4 to 15.0, P = 0.008; and mastery 7.5, usual care, at three months after a hospital admission for acute 4.2 to 10.7, P < 0.001) and the mental component score of the SF-36 (20.1, 3.3 to 36.8, P = 0.02). Improvements in the physicalcomponent score of the SF-36 did not reach significance (10.6, Conclusion Early pulmonary rehabilitation after admission to
hospital for acute exacerbations of COPD is safe and leads to We recruited 42 patients admitted to King’s College Hospital in statistically and clinically significant improvements in exercise London with a primary diagnosis of acute exacerbation of capacity and health status at three months.
COPD. All were deemed sufficiently unwell by the duty medicalregistrar to warrant admission to hospital. Exclusion criteriaincluded comorbidity that could limit exercise training. In addi- Introduction
tion, to allow for a suitable washout period, we also excluded Admissions to hospital for acute exacerbations of chronic patients who had attended a pulmonary rehabilitation obstructive pulmonary disease (COPD) are a massive burden to programme in the preceding year. All patients gave written the NHS. Over the past decade, such admissions have increased by 50%, and annual hospital costs for COPD in the United King-dom amount to more than £587m ($1.05bn;€850m).1 Exacerba- Protocol
tions are also associated with impaired quality of life, reduced All admitted patients received standard treatment, including exercise capacity, and increased risk of readmission.2 Interven- nebulised bronchodilators, oxygen, oral or intravenous antibiot- tions designed to hasten recovery and improve symptoms afteradmission to hospital may lead not only to reduced use of health The CONSORT checklist of items to include when reporting a randomised care in the future (and subsequent economic benefits to the BMJ Online First bmj.com
on self management of the disease, nutrition, and lifestyle issues).
Table 1 Patients’ characteristics on day of hospital discharge. Values are
Respiratory physiotherapists and nurses supervised the exercise means with standard deviations unless otherwise indicated component, as did health centre based fitness instructors. Physi- Usual care group (n=21)
Rehabilitation group (n=21)
otherapists, respiratory nurses, an occupational therapist, a dieti- cian, a respiratory doctor, a smoking cessation adviser, a social worker, a pharmacist, and a lay member of a patients’ group supervised education activities on a rolling rota. Patients also received individualised home exercise programmes, which encouraged at least 20 minutes of exercise per day.
Assessment of outcome
We reassessed primary outcome measures (exercise capacity and Unpaired t tests were used for comparisons between groups.
disease specific and generic health status) at three months afterhospital discharge. In addition, we recorded secondary outcome ics, non-invasive ventilation (if required), and a one to two week measures of use of hospital resources, including number of course of oral prednisolone (30-40 mg daily). On discharge from readmissions, hospital days, and visits to the accident and emer- hospital, patients were allocated to either an early pulmonary gency department not requiring admission. We gathered this rehabilitation programme (within 10 days of hospital discharge) information principally from hospital records, corroborated by or usual care. Both groups of patients were discharged having optimal medical treatment, with a summary of their admission,to the care of their general practitioner and received standard Blinding
follow up outpatient appointments with a pulmonary specialist.
Owing to the nature of the intervention and financial and logis- All patients received home diaries, which included a disease spe- tical considerations, it was not possible to blind the patients or the assessors. The assessors were either the investigator respon-sible for assignment or members of the pulmonary rehabilitation Baseline assessment
team who were directly or indirectly involved in the delivery of We made baseline assessments in the 24 hours before patients were discharged from hospital and assigned to the intervention.
We measured exercise capacity by the incremental shuttle walk Sample size calculation
test,6 a standardised, externally paced, corridor walking test, The primary outcome measure for the study was the incremen- which is reproducible after a single practice walk. Patients are tal shuttle walk distance. On the basis of previous audit data, a instructed to walk along a 10 metre course in time with sample size calculation estimated that at least 30 patients (15 in prerecorded signals; initial walking speed is set at 0.50 metres per each group) would be required to show a 50 metre difference in second, and increased each minute by 0.17 metres/second. The shuttle walk distance (standardised difference 1.2) with 90% distance walked correlates well with maximum consumption of oxygen. The incremental shuttle walk is commonly used in pul- Data analysis and statistical methods
monary rehabilitation programmes in the United Kingdom as a We analysed data on an intention to treat basis. We made no functional outcome measure of maximum exercise capacity. We attempt to impute “missing” data from those participants who used the St George’s respiratory questionnaire (SGRQ) and the were lost to follow up. We calculated means (standard deviations) chronic respiratory disease questionnaire (CRQ), both well vali- or medians (ranges or interquartile ranges) as appropriate. We dated in patients with COPD7 8 and often used outcome used unpaired t tests to compare mean differences between measures in pulmonary rehabilitation studies, to measure groups for SGRQ, CRQ, and SF-36 scores. Because of the highly disease specific health status. We measured generic health status skewed distribution we used Mann-Whitney and univariate with the short form, 36 item questionnaire for medical outcomes median regressions to compare median shuttle walks between groups. We used the Mann-Whitney test to test differences Assignment
between groups in hospital bed days. We used incident rate ratios A random number generator was our tool to assign an interven- and the Poisson regression for rates of hospital readmission and tion to the first patient entering the study. We used the minimisa- accident and emergency visits. We used SPSS, version 12, and tion method to assign patients further to the intervention group, Stata, version 8, for the computations.
taking into account five factors: age ( < 70 years or ≥ 70 years),sex, length of hospital admission ( < 7 days or ≥ 7 days), incremental shuttle walk distance at discharge ( < 100 metres or ≥ 100 metres), and predicted forced expiratory volume in one Flow and follow up of participants
second (FEV ; < 30% or ≥ 30%). Table 1 shows baseline charac- Figure 1 shows the progress of participants through the study.
We initially assessed 69 patients for eligibility over a six monthperiod. Seventeen patients were not enrolled for medical reasons Pulmonary rehabilitation
or met exclusion criteria: coexisting unstable ischaemic heart A multidisciplinary team ran the pulmonary rehabilitation disease (n = 7), pulmonary rehabilitation in preceding year programme, which consisted of two classes per week for eight (n = 4), coexisting probable or definite diagnosis of lung cancer weeks. Patients were given a choice of three locations around the (n = 3), chronic alcohol abuse (n = 2), and wheelchair bound London boroughs of Lambeth and Southwark, but the classes owing to rheumatoid arthritis (n = 1). Ten patients refused were run by the same team with the same equipment. Each class consent: “felt too ill” (n = 4), “clash with other social activities” lasted two hours, consisting of one hour of exercise (aerobic (n = 3), “no likely benefit to me” (n = 3). Of the 42 patients walking and cycling, strength training for the upper and lower recruited, three month exercise capacity and health status data limb) and one hour of educational activities (with an emphasis were not available for eight patients because they died (n = 3), BMJ Online First bmj.com
exceeded the recognised minimal clinically important differ- ences for these measures. In addition, the rehabilitation groupmade far fewer visits to accident and emergency departments, and we saw a trend towards reduced hospital readmission rate Discussion
Attendance at a community based pulmonary rehabilitation programme shortly after a hospital admission for an acute exac- erbation of COPD leads to clinically important improvements inexercise capacity and health status at three months. Further- more, the number of attendances at the accident and emergency department was lower and hospital admission was required in Comparison with other studies
Excellent evidence supports the benefits of pulmonary rehabili-
tation in stable patients with COPD.3 4 This study examines theeffects of this outpatient intervention in patients during the early recovery period after a hospital admission for an acute exacerba-tion. Despite optimal medical treatment during hospital were lost to follow up because they had moved abroad or out of admission, patients at discharge take considerable time to area (n = 2), developed serious comorbidity unrelated to COPD recover to baseline levels of physical functioning and health sta- (n = 2), and withdrew because of allocation to usual care (n = 1).
tus. Previous studies have shown that up to 25% of patients after The mean attendance rate at the pulmonary rehabilitation class an acute exacerbation do not fully recover to baseline peak flow was 73%, with 6 of the 18 patients attending less than 50% of the at three months10 and that the recovery period in health status is classes. No adverse events were reported in the early long even in patients who do not have further exacerbations.11 rehabilitation group. Table 2 shows baseline and three month Our data indicate that patients can safely participate in a data in the usual care and early pulmonary rehabilitation groups.
community based pulmonary rehabilitation programme for out- Exercise capacity, the SGRQ impacts and total score, all four patients shortly after an exacerbation and that such a domains of the CRQ, and the mental component score of the programme speeds up recovery from the debilitating effects of a SF-36 in favour of early pulmonary rehabilitation improved sig- hospital admission. Furthermore, the magnitude of the effects of nificantly. The magnitude of these mean improvements greatly early pulmonary rehabilitation on exercise capacity and health Table 2 Baseline and three month data. Data are mean scores (SD) and differences between groups were compared by using unpaired t tests unless
Usual care (n=16)
Early rehabilitation (n=18)
Mean difference between
At three months
At three months
groups (95% CI)
St George’s respiratory questionnaire (range 100-0)‡: Chronic respiratory disease questionnaire§: * Median difference.
‡Decreased score denotes improvement. Minimal clinically important difference is 4 points on the total score.
§Increased score denotes improvement. Minimal clinically important difference is 2.5 (dyspnoea domain), 2 (fatigue domain), 3.5 (emotion domain) and 2 (mastery domain).
¶Increased score denotes improvement.
**Incident rate ratio.
BMJ Online First bmj.com
status are considerably greater than, and in addition to, the What is already known on this topic
effects of bronchodilator or corticosteroid therapy.12 Hospital admission for acute exacerbations of chronic Limitations of the study
obstructive pulmonary disease (COPD) is an enormous The study did not explore the mechanisms by which early pulmonary rehabilitation achieves its effects. Possible explana-tions include physiological improvements in skeletal muscle Pulmonary rehabilitation is an effective, function, desensitisation to dyspnoea, and psychosocial lifestyle non-pharmacological intervention in the management of changes. Dysfunction of the skeletal muscles is well recognised in stable patients with COPD, and the recent guidelines from patients with COPD13 and is particularly marked during a hospi- the National Institute for Clinical Excellence recommend tal admission14 owing to a variety of factors, including atrophy that it should be made available to all patients who would resulting from disuse, systemic inflammatory mediators, and use of corticosteroids. A limitation of this study is that, for obviousreasons, it was not possible to blind patients to the intervention.
What this study adds
Hence a placebo effect cannot be excluded as the principal Early pulmonary rehabilitation, in the recovery period after mechanism for the improvements observed. However, it should hospital discharge after an admission for an acute be noted that early pulmonary rehabilitation led to considerable exacerbation of COPD, leads to significant improvements in improvements in the distances covered in the incremental shut- functional capacity and quality of life at three months tle walk. The maximum distance walked during this test correlates well with peak oxygen consumption,6 hence it is likelythat a true physiological training effect contributed to theimprovements. The psychological effects, effects of self education trend towards fewer hospital inpatient days. The results therefore about the disease, or placebo effects of pulmonary rehabilitation imply that early pulmonary rehabilitation may reduce usage of in an often socially isolated group of patients should not be healthcare resources and bring improvements in exercise capac- minimised. A recent, multicentre, randomised controlled trial showed that an education programme for patients (consisting of Larger randomised studies are required to determine weekly visits by a health professional for a two month period, whether the benefits of early pulmonary rehabilitation translate with monthly telephone follow up) led to reduced use of health- into improved health economics. Other unanswered questions care resources in patients with severe COPD.15 Another include the long term effects of early pulmonary rehabilitation, limitation of the study is that the assessors were not fully blinded and the optimal structure, location, and duration of pulmonary to treatment allocation as they may have been directly or indirectly involved in the delivery of the intervention. This intro- Despite medical optimisation during hospital admission for duces an element of bias to the results, but it is important to note acute exacerbations of COPD, early pulmonary rehabilitation that the SGRQ and the SF-36 questionnaires are completed by after discharge from hospital leads to additional notable the patients themselves, without direct input from investigators, improvements in exercise capacity and health status at three and the incremental shuttle walk and the CRQ are highly stand- ardised outcome measures that do not place subjective require- We thank the Southwark and Lambeth pulmonary rehabilitation team for running and supervising the rehabilitation programme described in thiswork.
Viability of the programme
Contributors: WD-CM conceived the idea of the study, obtained grant Exercise training after an acute exacerbation of COPD is not a funding, designed the protocol, recruited subjects, collected and analysed novel concept. Behnke et al looked at the effects of an initial, 10 data and wrote the first and final drafts of the manuscript. MIP helped day, inpatient training programme, followed by six months of design the protocol of the study, interpreted data, and helped write the first supervised home training, compared with usual care, in patients and final drafts of the manuscript. ND helped design the study, performedstatistical analysis of the data and helped write the first and final drafts of admitted for an acute exacerbation of COPD.16 They showed the manuscript. BJG helped design the study, recruited patients, interpreted improvements in six minute walking distance and sum scores on data and helped write the first and final drafts of the manuscript. JM was the the questionnaire on chronic respiratory disease at three months senior investigator, and will act as guarantor. He helped conceive the idea and six months after training compared with control. However, and design of the study, obtained grant funding, interpreted data, andhelped write the first and final drafts of the manuscript. Christine Jones and such a programme would not be viable in terms of manpower or Caroline Mooney helped in the recruitment of subjects. Renata Morello, finance, given that inpatient stay contributes 54% of all direct Sheena Radford, Julie Backley, Lynda Haggis, Claire Bradley, Lauren healthcare costs associated with COPD in the United Kingdom.17 Moore, and Debbie James were involved in data collection and were mem- In contrast, a community based pulmonary rehabilitation bers of the multidisciplinary team that provided the active intervention.
programme for outpatients is a more realistic option. Previous Funding: This study was supported by a British Lung Foundation Trevor data support the cost effectiveness of pulmonary rehabilitation Clay Memorial Grant. WD-CM is a clinical research training fellow of theMedical Research Council (UK). The Southwark and Lambeth pulmonary programmes on an outpatient basis and the likelihood of finan- rehabilitation team is in part funded by “Pursuing Perfection,” coordinated by the NHS Modernisation AgencyCompeting interests: None declared.
Possible health economic impact and outlook
Ethical approval: The local research ethics committee approved the study.
The a priori primary outcome measures were exercise capacity,as measured by the incremental shuttle walk, and health status.
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10 Seemungal TA, Donaldson GC, Bhowmik A, Jeffries DJ, Wedzicha JA. Time course and recovery of exacerbations in patients with chronic obstructive pulmonary disease. Am JRespir Crit Care Med 2000;161:1608-13.
Respiratory Muscle Laboratory, Guy’s, King’s, and St Thomas’ School of Medicine, 11 Spencer S, Jones PW. Time course of recovery of health status following an infective King’s College Hospital, London SE5 9PJ exacerbation of chronic bronchitis. Thorax 2003;58:589-93.
William D-C Man MRC clinical research fellow 12 Aaron SD, Vandemheen KL, Hebert P, Dales R, Stiell IG, Ahuja J, et al. Outpatient oral John Moxham professor of respiratory medicine prednisone after emergency treatment of chronic obstructive pulmonary disease. NEngl J Med 2003;348:2618-25.
King’s College Hospital, London SE5 9RS 13 Man WD, Soliman MG, Nikoletou D, Harris ML, Rafferty GF, Mustfa N, et al.
Nora Donaldson senior lecturer in statistics Non-volitional assessment of skeletal muscle strength in patients with chronic obstruc- Barry J Gray consultant physician in respiratory medicine tive pulmonary disease. Thorax 2003;58:665-9.
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Muscle force during an acute exacerbation in hospitalised patients with COPD and its Michael I Polkey consultant physician in respiratory medicine relationship with CXCL8 and IGF-I. Thorax 2003;58:752-6.
Correspondence to: W D-C Man [email protected] BMJ Online First bmj.com
New Zealand white rabbits were treated with Retin-A Micro (tretinoin gel) microsphere, 0.1%, at doses of 0.2, 0.5, and 1.0 mg/kg/day, administered topical y for 24 hours a day while wearing Elizabethan col ars to prevent ingestion of the drug. There appeared to be increased incidences of certain alterations, including domed head and hydrocephaly, typical of retinoid-induced fetal malformations