Pulmonary rehabilitation following exacerbations of chronic

obstructive pulmonary disease (Protocol)

Puhan M, Scharplatz M, Troosters T, Steurer J

This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The Cochrane
Library 2005, Issue 2
http://www.thecochranelibrary.com

Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease (Protocol)

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 TABLE OF CONTENTS
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
CRITERIA FOR CONSIDERING STUDIES FOR THIS REVIEW . . . . . . . . . . . . . . . . . . 2
SEARCH METHODS FOR IDENTIFICATION OF STUDIES . . . . . . . . . . . . . . . . . . . 2
METHODS OF THE REVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
POTENTIAL CONFLICT OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Table 01. MEDLINE & EMBASE search strategy . . . . . . . . . . . . . . . . . . . . . . . 5
COVER SHEET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease (Protocol) i

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd
Pulmonary rehabilitation following exacerbations of chronic
obstructive pulmonary disease (Protocol)

Puhan M, Scharplatz M, Troosters T, Steurer J

This record should be cited as:

Puhan M, Scharplatz M, Troosters T, Steurer J. Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary
disease. (Protocol) Cochrane Database of Systematic Reviews 2005, Issue 2. Art. No.: CD005305. DOI: 10.1002/14651858.CD005305.

This version first published online: 20 April 2005 in Issue 2, 2005.

Date of most recent substantive amendment: 20 February 2005

ABSTRACT
This is the protocol for a review and there is no abstract. The objectives are as follows:
To assess whether rehabilitation after acute care for exacerbations of COPD reduces hospital admissions, number of future exacerbations,
the need for outpatient care and mortality. The effect on HRQL and exercise capacity will also be assessed and on safety compared to
conventional community care.

BACKGROUND 2001). However, the articles focused on acute therapeutic inter-

Exacerbations and hospitalisations of patients with chronic ob-
structive pulmonary disease (COPD) represent a major health bur-
den in industrialized and developing countries for patients as well
as health care systems (Seemungal 1998; Sin 2002; Sullivan 2000;
Chan-Yeung 2004). Acute exacerbations are the most common
reason for hospital admissions and death among COPD patients
(Manino 2002). In addition, health-related quality of life (HRQL)
is reduced in COPD (Schlenk 1998) compared to the healthy
population and it is further impaired by acute and repeated exacer-
bations (Seemungal 1998). Patients are at risk for early death and
further exacerbations requiring hospitalisations. Mortality rates
during the year following a hospitalisation are around 35% (Al-
magro 2002; Connors 1996; Groenewegen 2003; Seneff 1995;
Vitacca 2001) and rehospitalisation rates around 60%.Connors
1996; Groenewegen 2003; Cydulka 1997; Martin 1982).
From the health care provider’s perspective, COPD is resource-
consuming (Sullivan 2000). Acute exacerbations account for over
70 percent of COPD-related costs because of emergency visits
and hospitalisations (Sullivan 2000; NHLBI 2001; Oostenbrink
2004). Thus the cost drivers for COPD care are emergency visits
and hospital admissions for acute exacerbations.
Recent position papers of the American College of Physicians and
American College of Chest Physicians provided recommendations
on the management of acute exacerbations (Bach 2001; Snow
Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease (Protocol)
Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd
ventions, but did not provide recommendations on how future
exacerbations and hospitalisations could be reduced, despite being
one of the main goals of COPD management. Respiratory rehabil-
itation could play an important role in the management of COPD
patients with repeated exacerbations. It combines interventions
on the respiratory system (i.e. smoking cessation, medications),
psychological support (i.e. patient education, psychological and
social support) and physical exercise and there is a large body of
evidence showing that respiratory rehabilitation improves exercise
capacity and health-related quality of life (HRQL) (Lacasse 2002),
and that may be cost effective (Griffiths 2001).
The effect of respiratory rehabilitation in patients in an unsta-
ble pulmonary condition is less clear. In addition, there might be
concerns that respiratory rehabilitation is not safe shortly after an
acute exacerbation. Therefore, our aim is to conduct a systematic
review to assess the effectiveness and safety of respiratory rehabil-
itation after acute exacerbations of COPD.
The protocol for this Cochrane review is based upon an unpub-
lished non-Cochrane systematic review. This will be submitted for
publication outside the Cochrane Library in early 2005.
OBJECTIVES
To assess whether rehabilitation after acute care for exacerbations
1
of COPD reduces hospital admissions, number of future exacer-
bations, the need for outpatient care and mortality. The effect on
HRQL and exercise capacity will also be assessed and on safety
compared to conventional community care.
CRITERIA FOR CONSIDERING
STUDIES FOR THIS REVIEW
We will perform a very broad literature search to identify any
randomised controlled studies on respiratory rehabilitation in
COPD patients. The search strategy for Medline and Embase
can be found in Table 01. In addition, we will use the Pub-med
“related articles” function for included studies to identify further
studies. Also, we will perform a Science citation index search for
studies that cite included studies as well as studies that are cited
by included studies.

In addition, a search of the Cochrane Airways Group Specialised

Types of studies Register of COPD trials will be carried out using the following
terms:
Randomised controlled trials and controlled clinical trials com-
paring rehabilitation after acute exacerbation of COPD to con- (rehabilitat* or fitness or exercis* or physical* or train* or kinesio*
ventional community care. or endurance*) and (acute* or exacerb* or emerg* or hospital* or
admit* or admis* or discharg*)
Types of participants
COPD patients after in- or outpatient care for acute exacerbation. Screening reference lists from included primary studies, review
More than 90% of study participants must be COPD patients. articles and conference proceedings (ATS, ERS) and contacting
experts in the field will complete the searches. There will be no
Types of intervention restrictions of language of the articles.
Any inpatient and/or outpatient rehabilitation program after acute
care including at least physical exercise.
METHODS OF THE REVIEW
Types of outcome measures
Primary outcome measure: Two members of the review team will independently assess the
Readmissions and length of readmissions titles and abstracts of all identified citations. Decisions of the two
reviewers will be recorded (order or reject) and then compared.
Secondary outcomes:
Any disagreements will be resolved by consensus with close
Health-related quality of life as measured by generic (e.g. SF-36)
attention to the inclusion/exclusion criteria. Two reviewers will
or disease-specific (e.g. CRQ, SGRQ) questionnaires.
evaluate the full text of all potentially eligible papers and make
Exacerbation rates (after discharge)
a decision whether to include or exclude each study according
Number of outpatient visits
to the inclusion and exclusion criteria specified above. Any
Mortality
disagreements will be resolved by consensus with close attention
Functional exercise capacity as measured by 2-, 4-, 6-, 12-minute-
to the inclusion/exclusion criteria. All studies that do not fulfil
walk test or a shuttle walk test.
all of the criteria will be excluded and their bibliographic details
Maximal exercise capacity
listed, with the reason for exclusion. A third reviewer will resolve
Exercise endurance
any discrepancies if the two reviewers disagree.
Withdrawals
Adverse events Data extraction strategy
Costs Two independent reviewers will independently screen the full text
of the included studies and record details about study design,
interventions, patients and outcome measures in a predefined
SEARCH METHODS FOR Windows Excel forms. A small sample of studies with high
IDENTIFICATION OF STUDIES likelihood for inclusion and exclusion will serve to pretest the data
forms. A third reviewer will resolve any discrepancies if the two
See: Cochrane Airways Group methods used in reviews. reviewers disagree. Bibliographic details such as author, journal,
year of publication and language, will be registered. To obtain
We will perform literature searches in the following electronic
missing information, we will contact authors of primary studies.
databases:
MEDLINE Quality assessment strategy
EMBASE Two reviewers will independently evaluate all included controlled
PEDro (Physiotherapy Evidence Database) trials using a list of selected quality items assessing components of
The Cochrane Central Register of Controlled Trials (CENTRAL, internal validity as: + Item properly addressed; +/- Item partially
Issue 4, 2004) addressed; - Item not addressed:
Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease (Protocol) 2
Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd
Concealment of allocation to treatment groups CRQ ± 0.5 on seven point scales; and St. George Respiratory
Prestratification (prognostically relevant variables) Questionnaire ± 4 points (Schunemann 2003). Where possible
Description of randomisation procedure we will also assess the number of patients who show changes that
Registration of loss to follow-up are greater than the MID, including those who show significant
Registration of co-interventions for each group increase and decrease in each treatment group, and compare the
Blinding of outcome assessors net benefit between treatments. All statistical analyses will be done
Check success of blinding with RevMan analysis software 1.0.2.

We will record the initial degree of discordance between the Numbers needed to treat (NNT) will be calculated from the
reviewers and correct discordant scores based on obvious errors. pooled OR and its 95% CI applied to a specified baseline risk
We will resolve discordant scores based on real differences in using an online calculator (Cates 2003). This calculator converts
interpretation through consensus or third party arbitration. The the risk in the placebo group to the corresponding odds, applies
reviewers will not be blinded to names of authors, institutions, the OR to estimate the odds in the treated group, and converts that
journals or the outcomes of the trials. odds to the corresponding risk and calculates the risk difference,
the inverse of which is the NNT.
Methods of analysis and synthesis
We will use forest plots to compare results across the Bias
trials. If appropriate we will explore sources of heterogeneity We will attempt to obtain data from intention-to-treat and per-
(i.e. differences between characteristics of the studies) using protocol populations. We will pool all data available and perform
multivariable regression models (Meta-regression analysis) where a sensitivty analysis to see whether this makes a difference in the
a priori defined clinical and methodological items form the quality meta-analyses.
assessment will serve as explanatory variables. These may include We will perform funnel plots to determine whether our summary
severity of disease (GOLD criteria), in- or outpatient treatment estimates are affected by publication bias.
of exacerbation, length of the intervention (< 6 months), length
of follow-up and comprehensiveness of rehabilitation programme
(patient education, psychosocial support, breathing exercises, POTENTIAL CONFLICT OF
relaxation therapies). INTEREST
We will pool trial results by calculating weighted mean differences
None declared.
and relative risk reductions. If random and fixed effect models
produce the same results, we will present the results from fixed
effect models only. No pooling will be undertaken in presence of SOURCES OF SUPPORT
significant heterogeneity (p<0.1 for Q statistic).
External sources of support
Whenever possible, estimates and confidence limits will be related
to the minimal important difference (MID)(Schunemann 2005) • No sources of support supplied
for each outcome. We will assess whether the estimates and 95%
confidence limits for the difference between study groups exceeded Internal sources of support
the MID (for the Six-minute walk distance the MID is ± 53 meters; • No sources of support supplied

REFERENCES

Additional references Cates 2003

Cates C. Visual Rx. Online NNT Calculator. http:
Almagro 2002 //www.nntonline.net/: Cates C, 2003.
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Chan-Yeung 2004
et al.Mortality after hospitalization for COPD. Chest 2002;121(5):
Chan-Yeung M, Ait-Khaled N, White N, Ip MS, Tan WC. The
1441–1448.
burden and impact of COPD in Asia and Africa. International Journal
of Tuberculosis and Lung Disease 2004;8(1):2–14.
Bach 2001
Bach PB, Brown C, Gelfand SE, McCrory DC. Management of acute Connors 1996
exacerbations of chronic obstructive pulmonary disease: a summary Connors AF, Jr, Dawson NV, Thomas C, Harrell FE, Jr, Desbiens
and appraisal of published evidence. Annals of Internal Medicine 2001; N, Fulkerson WJ, et al.Outcomes following acute exacerbation of
134(7):600–620. severe chronic obstructive lung disease. The SUPPORT investigators
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 (Study to Understand Prognoses and Preferences for Outcomes and
Risks of Treatments). American Journal of Respiratory and Critical
Care Medicine 1996;154(4 Pt 1):959–967.
Cydulka 1997
Cydulka RK, McFadden ER, Jr, Emerman CL, Sivinski LD, Pisanelli
W, Rimm AA. Patterns of hospitalization in elderly patients with
asthma and chronic obstructive pulmonary disease. American Journal
of Respiratory and Critical Care Medicine 1997;156(6):1807–12.
Devereaux 2002
Devereaux PJ, Schunemann HJ, Ravindran N, Bhandari M, Garg
AX, Choi PT, et al.Comparison of mortality between private for-
profit and private not-for-profit hemodialysis centers: a systematic
review and meta-analysis. Journal of the American Medical Association
2002;288(19):2449–57.
Griffiths 2001
Griffiths TL, Phillips CJ, Davies S, Burr ML, Campbell IA. Cost
effectiveness of an outpatient multidisciplinary pulmonary rehabili-
tation programme. Thorax 2001;56(10):779–84.
Groenewegen 2003
Groenewegen KH, Schols AM, Wouters EF. Mortality and mortal-
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Jaeschke 1989
Jaeschke R, Singer J, Guyatt GH. Measurement of health status.
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Clinical Trials 1989;10(4):407–15.
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Lacasse Y, Brosseau L, Milne S, Martin S, Wong E, Guyatt GH, et
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ease. Cochrane Database of Systemnatic Reviews 2002, Issue 3.
Manino 2002
Mannino DM. COPD : Epidemiology, Prevalence, Morbidity
and Mortality, and Disease Heterogeneity. Chest 2002;121(90050):
121S–6S.
Martin 1982
Martin TR, Lewis SW, Albert RK. The prognosis of patients with
chronic obstructive pulmonary disease after hospitalization for acute
respiratory failure. Chest 1982;82(3):310–314.
NHLBI 2001
National Heart
LaBI, U.S.Deapartment of Health and Human Services NIoH. Data
Fact Sheet: Chronic Obstructive Pulmonary Disease (COPD): http:
//www nhlbi nih gov/health/public/lung/other/copd_fact htm#cost
2001.
Oostenbrink 2004
Oostenbrink JB, Rutten-van Molken M. Resource use and risk factors
in high-cost exacerbations of COPD. Respiratory Medicine 2004;98:
883–91.
Redelmeier 1997
Redelmeier DA, Bayoumi AM, Goldstein RS, Guyatt GH. Interpret-
ing small differences in functional status: the Six Minute Walk test
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in chronic lung disease patients. American Journal of Respiratory and
Criticial Care Medicine 1997;155(4):1278–82.
Schlenk 1998
Schlenk EA, Erlen JA, Dunbar-Jacob J, McDowell J, Engberg S,
Sereika SM, et al.Health-related quality of life in chronic disorders:
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Research 1998;7(1):57–65.
Schunemann 2003
Schunemann HJ, Griffith L, Jaeschke R, Goldstein R, Stubbing D,
Guyatt GH. Evaluation of the minimal important difference for the
feeling thermometer and the St. George’s Respiratory Questionnaire
in patients with chronic airflow obstruction. Journal of Clinical Epi-
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Schunemann H, Puhan M, Goldstein R, Jaeschke R, Guyatt G. Mea-
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Seemungal T, Donaldson G, Paul E, Bestall J, Jeffries D, Wedzicha
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4
 ADDITIONAL TABLES

Table 01. MEDLINE & EMBASE search strategy

Search strategy
1 lung diseases obstructive.af.
2 chronic obstructive lung disease.af.
3 chronic obstructive pulmonary disease.af.
4 exp pulmonary disease chronic obstructive/
5 or/1-4
6 rh.fs.
7 rehabilitation.de.
8 exp exercise movement techniques/
9 exp exercise test/
10 exp physical endurance/
11 exp muscle training/
12 exp kinesiotherapy/
13 exp exercise/
14 or/6-13
15 5 and 14
16 clinical trial.pt.
17 exp epidemiologic methods/
18 exp controlled study/
19 exp major clinical study/
20 exp evidence based medicine/
21 or/16-20
22 15 and 21
23 comment.pt.
24 editorial.pt.
25 exp editorial/
26 or/23-25
27 22 not 26
28 remove duplicates from 27

COVER SHEET
Title Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease
Authors Puhan M, Scharplatz M, Troosters T, Steurer J
Contribution of author(s) Information not supplied by author
Issue protocol first published 2005/2
Date of most recent amendment 24 February 2005
Date of most recent 20 February 2005
SUBSTANTIVE amendment
What’s New Information not supplied by author
Contact address Dr Milo Puhan
Horten Centre
University Hospital of Zurich
Postfach Nord
Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease (Protocol) 5
Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd
 Zurich
CH-8091
SWITZERLAND
E-mail: milo.puhan@evimed.ch
Tel: +41 1 255 87 09
Fax: +41 1 255 97 20
DOI 10.1002/14651858.CD005305
Cochrane Library number CD005305
Editorial group Cochrane Airways Group
Editorial group code HM-AIRWAYS

Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease (Protocol) 6

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd