Action Plan for Chronic Obstructive Pulmonary Desease

Action plans for chronic obstructive pulmonary disease

(Review)

Turnock AC, Walters EH, Walters JAE, Wood-Baker R

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library2006, Issue 3

http://www.thecochranelibrary.com

1Action plans for chronic obstructive pulmonary disease (Review)

Copyright © 2006 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

http://www.thecochranelibrary.com

T A B L E O F C O N T E N T S

1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2CRITERIA FOR CONSIDERING STUDIES FOR THIS REVIEW . . . . . . . . . . . . . . . . . .

3SEARCH METHODS FOR IDENTIFICATION OF STUDIES . . . . . . . . . . . . . . . . . . .

3METHODS OF THE REVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4DESCRIPTION OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6METHODOLOGICAL QUALITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9POTENTIAL CONFLICT OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . .

9ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11Characteristics of included studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14Characteristics of excluded studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

15Characteristics of ongoing studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

16ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

16Comparison 01. Action Plan versus usual care . . . . . . . . . . . . . . . . . . . . . . . . .

18INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

18COVER SHEET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

19GRAPHS AND OTHER TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

19Analysis 01.01. Comparison 01 Action Plan versus usual care, Outcome 01 Number of admissions to hospital in 12

months . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

20Analysis 01.02. Comparison 01 Action Plan versus usual care, Outcome 02 Visits to GP/PN in 6 months . . . .

20Analysis 01.03. Comparison 01 Action Plan versus usual care, Outcome 03 Number scheduled GP visits in 12 months

20Analysis 01.04. Comparison 01 Action Plan versus usual care, Outcome 04 Number emergency visits to GP for COPD

in 12 months . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

21Analysis 01.05. Comparison 01 Action Plan versus usual care, Outcome 05 Number of total GP visits in 12 months

21Analysis 01.06. Comparison 01 Action Plan versus usual care, Outcome 06 Number of times treated in the emergency

department in 12 months . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

21Analysis 01.07. Comparison 01 Action Plan versus usual care, Outcome 07 Days on Antibiotics in 6 months . . .

22Analysis 01.08. Comparison 01 Action Plan versus usual care, Outcome 08 Days on corticosteroids in 6 months . .

22Analysis 01.09. Comparison 01 Action Plan versus usual care, Outcome 09 Patients initiating antibiotics in 6 months

23Analysis 01.10. Comparison 01 Action Plan versus usual care, Outcome 10 Patients initiating steroids in 6 months .

23Analysis 01.11. Comparison 01 Action Plan versus usual care, Outcome 11 Courses of Antibiotics in 12 months . .

24Analysis 01.12. Comparison 01 Action Plan versus usual care, Outcome 12 Courses of oral corticosteroids in 12 months

24Analysis 01.13. Comparison 01 Action Plan versus usual care, Outcome 13 Number of subjects with >= 1 exacerbation

COPD with antibiotics in 12 months . . . . . . . . . . . . . . . . . . . . . . . . .

25Analysis 01.14. Comparison 01 Action Plan versus usual care, Outcome 14 Length of exacerbations . . . . . .

25Analysis 01.15. Comparison 01 Action Plan versus usual care, Outcome 15 SGRQ symptom scores at 6 months . .

26Analysis 01.16. Comparison 01 Action Plan versus usual care, Outcome 16 SGRQ activity scores at 6 months . . .

26Analysis 01.17. Comparison 01 Action Plan versus usual care, Outcome 17 SGRQ impact scores at 6 months . . .

27Analysis 01.18. Comparison 01 Action Plan versus usual care, Outcome 18 SGRQ total scores at 6 months . . . .

27Analysis 01.19. Comparison 01 Action Plan versus usual care, Outcome 19 SGRQ symptom scores at 12 months .

28Analysis 01.20. Comparison 01 Action Plan versus usual care, Outcome 20 SGRQ activity scores at 12 months . .

28Analysis 01.21. Comparison 01 Action Plan versus usual care, Outcome 21 SGRQ impact scores at 12 months . .

29Analysis 01.22. Comparison 01 Action Plan versus usual care, Outcome 22 SGRQ total scores at 12 months . . .

iAction plans for chronic obstructive pulmonary disease (Review)


29Analysis 01.23. Comparison 01 Action Plan versus usual care, Outcome 23 FEV1 (mls) at 6 months . . . . . .

29Analysis 01.24. Comparison 01 Action Plan versus usual care, Outcome 24 FEV1 (mls) at 12 months . . . . .

30Analysis 01.25. Comparison 01 Action Plan versus usual care, Outcome 25 FEV1 % predicted at 6 months . . .

30Analysis 01.26. Comparison 01 Action Plan versus usual care, Outcome 26 FEV1 % predicted at 12 months . . .

30Analysis 01.27. Comparison 01 Action Plan versus usual care, Outcome 27 FEV1/FVC at 6 months . . . . . .

31Analysis 01.28. Comparison 01 Action Plan versus usual care, Outcome 28 FEV1/FVC at 12 months . . . . .

31Analysis 01.29. Comparison 01 Action Plan versus usual care, Outcome 29 Functional Capacity . . . . . . .

31Analysis 01.30. Comparison 01 Action Plan versus usual care, Outcome 30 Number of days symptoms recorded in 6

months . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

32Analysis 01.31. Comparison 01 Action Plan versus usual care, Outcome 31 Days of breathing recorded as usual in 6

months . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

32Analysis 01.32. Comparison 01 Action Plan versus usual care, Outcome 32 Days of breathing recorded as mild in 6

months . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

32Analysis 01.33. Comparison 01 Action Plan versus usual care, Outcome 33 Days of breathing recorded as moderate in 6

months . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

33Analysis 01.34. Comparison 01 Action Plan versus usual care, Outcome 34 Days of breathing recorded as severe in 6

months . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

33Analysis 01.35. Comparison 01 Action Plan versus usual care, Outcome 35 Mortality . . . . . . . . . . .

34Analysis 01.36. Comparison 01 Action Plan versus usual care, Outcome 36 Days lost from work . . . . . . .

34Analysis 01.37. Comparison 01 Action Plan versus usual care, Outcome 37 HADS anxiety . . . . . . . . .

34Analysis 01.38. Comparison 01 Action Plan versus usual care, Outcome 38 HADS depression . . . . . . . .

35Analysis 01.39. Comparison 01 Action Plan versus usual care, Outcome 39 SMI well knowledge . . . . . . .

35Analysis 01.40. Comparison 01 Action Plan versus usual care, Outcome 40 SMI well actions . . . . . . . . .

35Analysis 01.41. Comparison 01 Action Plan versus usual care, Outcome 41 SMI early exacerbation knowledge . .

36Analysis 01.42. Comparison 01 Action Plan versus usual care, Outcome 42 SMI early exacerbation actions . . . .

36Analysis 01.43. Comparison 01 Action Plan versus usual care, Outcome 43 SMI severe exacerbation knowledge . .

36Analysis 01.44. Comparison 01 Action Plan versus usual care, Outcome 44 SMI severe exacerbation actions . . .

iiAction plans for chronic obstructive pulmonary disease (Review)


Action plans for chronic obstructive pulmonary disease(Review)

Turnock AC, Walters EH, Walters JAE, Wood-Baker R

This record should be cited as:

Turnock AC, Walters EH, Walters JAE, Wood-Baker R. Action plans for chronic obstructive pulmonary disease. Cochrane Database ofSystematic Reviews 2005, Issue 4. Art. No.: CD005074. DOI: 10.1002/14651858.CD005074.pub2.

This version first published online: 19 October 2005 in Issue 4, 2005.

Date of most recent substantive amendment: 23 July 2005

A B S T R A C T

Background

The effectiveness of action plans as treatment for chronic obstructive pulmonary disease (COPD) is not known.

Objectives

To assess the efficacy of action plans in the management of COPD.

Search strategy

We searched the Cochrane Airways Group Specialised Register, CENTRAL, MEDLINE, CINAHL and the National Research Register

of Ongoing Trials. We also searched reference lists of identified studies. The search was completed in August 2004.

Selection criteria

Randomised controlled trials of action plans in COPD. Studies with a primary diagnosis of asthma excluded.

Data collection and analysis

Two reviewers independently assessed trial quality and extracted data. Investigators were contacted for additional information when

necessary. Study results were combined in meta-analyses using the Cochrane Collaboration software RevMan.

Main results

There was evidence of a positive effect of action plans on self-management knowledge. The mean difference (MD) for recognition of a

severe exacerbation was 2.50; 95% confidence interval 1.04 to 3.96, for self-action in severe exacerbations MD 1.50; 95% confidence

interval 0.62 to 2.38 and the use of antibiotics MD 6.00; 95% confidence interval 2.68 to 9.32. There was also evidence of a positive

effect on the initiation of antibiotics (odds ratio (OR) 10.16; 95% confidence interval 2.02 to 51.09) and/or oral steroids (OR 6.58;

95% confidence interval 1.29 to 33.62). However, there was no evidence of significant effects on healthcare utilisation, health-related

quality of life, lung function, functional capacity, symptom scores, mortality, anxiety, or depression. No trials used as outcomes: number

of exacerbations, length of exacerbations, or days lost from work.

Authors’ conclusions

This review shows there is evidence that action plans aid people with COPD in recognising and reacting appropriately to an exacerbation

of their symptoms via the self-initiation of antibiotics or steroids. Further research needs to be completed with more comprehensive

outcomes measures in order to ascertain whether this results in significantly decreased morbidity and/or mortality.

P L A I N L A N G U A G E S U M M A R Y

Chronic obstructive pulmonary disease (COPD) is a progressive disease characterised by exacerbations of symptoms which decrease

quality of life. Action plans are designed to help an individual recognise a deterioration in their symptoms and initiate changes to

treatment early. This is designed to reduce the impact of the exacerbation.



This review found that the use of action plans results in an increased ability to recognise and react appropriately to an exacerbation by

individuals. Unfortunately there was no evidence these behavioural changes alter health-care utilisation.

B A C K G R O U N D

Chronic obstructive pulmonary disease (COPD) is a progressive

respiratory condition usually related to cigarette smoking. The

prevalence of COPD was estimated to be 10.2 million or 5.9% of

the population in adults >25 years old in the United States in 1997

(Mannino 2002). Worldwide, COPD is expected to move up from

the 12th leading cause of disability-adjusted life-years (DALYs) in

1990 to the fifth leading cause in 2020 (Mannino 2002). Thus

COPD places a strain on patients, families, carers and the whole

community. It is a costly disease in terms of loss of quality of life,

decreased ability to contribute to society, and economic costs. The

estimated direct medical costs of COPD in the United States in

1993 was US$14.7 billion (Mannino 2002).

Historically, there has been debate over the definition and criteria

for the diagnosis of COPD, as well as uncertainty about its treat-

ment. The global initiative for chronic obstructive lung disease

(GOLD) criteria define COPD as a disease state characterised by

airflow limitation that is not fully reversible. The airflow limitation

is usually progressive and associated with an abnormal inflamma-

tory response of the lungs to noxious particles or gases (Pauwels

2001). The presence of a post-bronchodilator FEV1 <80% of the

predicted value in combination with an FEV1/FVC <70% con-

firms the presence of airflow limitation that is not fully reversible

(Pauwels 2001).

A major problem associated with COPD is the occurrence of ex-

acerbations, or periodic worsening of symptoms and lung func-

tion. Symptoms during exacerbations include increased shortness

of breath, cough and sputum production. These exacerbations re-

sult in increased utilisation of healthcare services, and decline in

health-related quality of life. They are usually managed with in-

creased bronchodilator medication, oral corticosteroids and an-

tibiotics. Early identification and treatment of exacerbations is im-

portant, although studies have shown that only up to 60% of exac-

erbations are reported to a healthcare provider (Wilkinson 2004).

The use of ’action plans’ aims to encourage early intervention.

They do this by providing guidelines on how to recognise an ex-

acerbation via symptoms, sometimes with associated lung func-

tion changes. This is used to define when to alter the medication

regime and visit healthcare providers. However, the evidence to

support the use of action plans in COPD at present is limited.

While action plans have been proven effective in the management

of asthma, their role in COPD is unclear. It cannot necessarily be

assumed that an action plan will have the same effect in COPD

as in asthma. For example, although it has been shown that asth-

matics who received a patient brochure and two two-hour group

education sessions had improved steroid inhaler compliance com-

pared to control asthmatics, COPD patients were unaffected by a

similar intervention (Gallefoss 1999).

As patients who receive prompt therapy after the onset of an ex-

acerbation recover sooner and COPD patients who consistently

neglect treatment for their exacerbations have a poorer quality of

life (Wilkinson 2004), any intervention that leads to better and

earlier intervention for exacerbations would be expected to have a

beneficial effect on health-related quality of life. However, studies

of self-management of COPD involving combinations of educa-

tion programs, brochures, exercise programs, and action plans have

produced varied results, ranging from inconclusive (Monninkhof

2003), to beneficial (Bourbeau 2003 (2); Worth 2004). They have

also failed to identify which components of comprehensive self-

management interventions are most effective (Bourbeau 2003 (1);

Bourbeau 2004), specifically whether action plans are beneficial

(Monninkhof 2003). This review aims to determine whether ac-

tion plans alone, or as part of a broader self-management inter-

vention, are an effective way to manage COPD exacerbations.

O B J E C T I V E S

The primary objective for this review was to determine whether

action plans for the management of exacerbations improve health

outcomes in people with COPD.

C R I T E R I A F O R C O N S I D E R I N G

S T U D I E S F O R T H I S R E V I E W

Types of studies

Randomised controlled trials (RCTs), excluding cross-over trials.

Types of participants

Participants were all patients with primary COPD diagnosed by

a health practitioner using spirometric criteria such as those of

GOLD. Thus participants must have had a FEV1 <80% of pre-

dicted value, and a FEV1/FVC <70% of the predicted value. They

must also have had a history of smoking. Studies with participants

who had a primary diagnosis of asthma were identified and ex-

cluded.

Types of intervention

The intervention in this study was the use of an action plan, de-

fined as the use of guidelines which outline self-initiated interven-

tions (such as changing medication regime or visiting the GP or



hospital) which are undertaken appropriately in response to alter-

ations in the state of the patients’ COPD (e.g. increase in breath-

lessness, increased amount or purulence of sputum) that suggest

the commencement of an exacerbation. Broader self-management

plans, which include primary interventions such as education and

exercise programs were not included, irrespective of whether they

included an action plan. The active intervention was compared to

’usual care’.

Types of outcome measures

Primary outcomes included:

1. Hospital admission

2. Healthcare utilisation: scheduled and unscheduled GP visits;

treatment in an emergency department

3. Use of medications: number of courses and days of antibiotic

and/or steroid use; number of participants initiating antibiotic

and/or steroid use

Secondary outcomes included:

1. Number of acute exacerbations

2. Length of exacerbations

3. Health related quality of life (HRQoL) using the St George’s

Respiratory Questionnaire (SGRQ)

4. Lung function

5. Functional capacity

6. Symptom scores

7. Mortality

8. Days lost from work

Additional outcomes:

1. Anxiety and depression scores using the Hospital Anxiety and

Depression scale (HADS)

2. Standardised self management interview for COPD (SMI)

S E A R C H M E T H O D S F O R

I D E N T I F I C A T I O N O F S T U D I E S

See: Airways Group methods used in reviews.

RCTs were identified using the Cochrane Airways Group

Specialised Register of RCTs. The Register’s records coded as

’COPD’ were searched using the following terms:

“action plan*” OR action-plan* OR self-car* OR “self car*” OR

self-manag* OR “self manag*” OR “management plan*” OR

management-plan* OR “management program*” OR behaviour*

OR behavior* OR educat*

A total of 197 references were found.

An advanced search on the Collaborations trial register

CENTRAL was carried out using the terms:

(Pulmonary disease, chronic obstructive) AND (self care OR

self administration OR self-evaluation programs OR models

educational OR cooperative behavior OR health behavior)

This search retrieved 8 references, none of which added to those

identified by the Airways Register search.

A direct search of CINAHL was completed using the search

terms:

(EXP(“Lung diseases, obstructive”) AND (“self care” OR “self-

care” OR “patient education” OR “behavioral changes” OR

“behavioral objectives”) AND EXP(“clinical trials”)

This search retrieved 77 references, none of which added to those

identified by the Airways Register search.

A direct search of MEDLINE via PubMed was completed using

the search:

“Pulmonary Disease, Chronic Obstructive”[MeSH] AND

(“self care”[MeSH] OR “patient education”[MeSH] OR

“Models, Educational”[MeSH] OR “Patient Education

Handout”[Publication Type] OR “Behavior”[MeSH]

OR “Behavior Therapy”[MeSH] OR “Cooperative

Behavior”[MeSH] OR “Behavior control”[MeSH] OR

“Behavioral Medicine”[MeSH] OR “Health Promotion”[MeSH]

This search was limited to RCTs and retrieved 53 references,

none of which added to those identified by the Airways Register

search.

A direct search of the National Research Register of Ongoing

Trials was also completed. The terms used were:

((pulmonary disease, chronic obstructive) AND ((action plan*)

OR action-plan* OR self-car* OR (self car*) OR self-manag* OR

(self manag*) OR (management plan*) OR management-plan*

OR (management program*) OR behaviour* OR behavior* OR

educat*))

This retrieved 23 records. One record had not been identified by

the search of the Airways Register.

From the full text papers obtained, the bibliographic lists were

hand searched for additional articles. This revealed no additional

articles. We also contacted researchers for information about

their ongoing trials.

M E T H O D S O F T H E R E V I E W

Titles, abstracts and citations were reviewed to assess relevance for

full review. Full text articles were reviewed and assessed by two

independent reviewers to determine inclusion or exclusion based

on the criteria set down for considering studies for this review (see

above), and grade of allocation concealment. Jadad score was also

assessed.

Any discrepancies were resolved via consensus between reviewers.

Data extraction

Two reviewers (AT & JW) independently extracted the data

(using a standardised form) considering the study population,

interventions and primary and secondary outcomes.



Included studies were then assessed for quality by the two

reviewers. Any discrepancies were again resolved via consensus.

Allocation concealment was first assessed in accordance with the

Cochrane approach. Each trial was given a score:

Grade A - adequate; i.e. formal randomisation using sealed

envelope

Grade B- unclear; uncertain or unclear concealment

Grade C- inadequate; clearly inadequate concealment, i.e.

assignment by alternation

As it was not possible for the trials to be double-blinded the

maximum Jadad score obtainable was three. Trials were evaluated

by sensitivity analysis using quality grades.

Analysis

The review included only RCTs in the analysis. Outcomes were

analysed as binary or continuous outcomes as appropriate for the

distribution of the data and used standard statistical techniques.

Cluster trials were combined using generic inverse variance (GIV)

method.

For dichotomous outcomes, the odds ratio was calculated with

95% confidence intervals by the method of Peto.

For continuous outcomes, the weighted mean difference and 95%

confidence intervals were calculated.

A funnel plot was constructed to identify possible asymmetry

suggesting publication bias.

Heterogeneity was explored. If significant heterogeneity existed,

subgroup analysis of severity of COPD was to be done.

We obtained the effect estimates (mean difference or odds/risk

ratio) and the 95% confidence interval (CI) for dichotomous and

continuous outcomes by entering data into the appropriate tables

for analysis in Rev Man. This enabled us to combine individually

randomised and cluster trials using the GIV. The 95% CI was

converted to SE using the equation:

SE = (upper limit - lower limit)/3.92

When data were expressed as a % of each group with one or more

episodes of health-care utilisation we calculated the number of

episodes (n) from the number of participants in the group (N).

Using RevMan an OR and 95% CI were obtained and the In(OR)

and In(SE) calculated.

In(OR) = InOR In(SE) = (In(upper limit)-In(lower limit))/3.92

Effect size = In(OR)/1.81 Standard error = In(SE)/1.81

Where 3.92 is 2 x 1.96 standard errors wide and calculates the

95% confidence interval.

To re-express the log odds ratio as standardised mean difference

divide by π/√3=1.81.

When data included a P value, the number of participants in the

both groups (Ne and Ni), and score for each group, the mean

difference(MD) was calculated, and the following procedure was

undertaken to arrive at the estimate and standard error.

t-statistic = tinv(P value, degrees of freedom) where degrees of

freedom = (Ne+Ni)-2

SE of MD = MD/t-statistic SD=SE of MD/(√(1/Ne +

1/Ni))

Once entered into RevMan, we can obtain the weighted mean

difference (WMD) and 95% CI and thus calculate the SE via the

equation:

SE = (upper limit - lower limit)/3.92

Where 3.92 is 2 x 1.96 standard errors wide and calculates the

95% confidence interval.

D E S C R I P T I O N O F S T U D I E S

See: Table of included studies.

Three studies were included in the review, McGlone 2004 was

a prospective parallel-group cluster randomised study; McGeoch

2004 was a prospective cluster randomised controlled trial; Watson

1997 was a parallel-group block randomised controlled study. All

studies recruited participants through general practitioners (GPs),

McGlone 2004 recruited from 54 GPs and Watson 1997 recruited

from 22 GPs. McGeoch 2004 also identified patients through pre-

scription databases of bronchodilators and inhaled corticosteroid

prescriptions to increase number of patients screened.

Baseline participant characteristics revealed that all the studies in-

volved people of a similar age. There were more male participants

in all studies, with significantly more in McGlone 2004 (73% in

intervention, 93% in control). The percentage of current smokers

in each group varied, with 24% in intervention and 33% in con-

trol still smoking in Watson 1997, 53% in intervention and 30%

in control still smoking in McGlone 2004, and 31% in interven-

tion and 23% in control still smoking in McGeoch 2004. The

FEV1% predicted varied slightly between groups in all studies:

37% (SD 14) intervention and 36% (SD 16) control in Watson

1997, 46.3% (SD 16) intervention and 44.2% (SD 15.8) con-

trol in McGlone 2004, and 54.6% (SD 18,7) intervention and

53.1% (SD 18.1) control in McGeoch 2004. According to the

COPDX plan McKenzie 2003, which are Australian and New

Zealand guidelines on the diagnosis and management of COPD,

this places the mean of participants in the Watson 1997 in the se-

vere COPD grouping and in McGeoch 2004 and McGlone 2004

in the moderate COPD category. In terms of baseline SGRQ the

scores were similar between groups.

All studies required participants to fit diagnostic criteria for COPD

as their major functionally limiting disease, as defined by the Amer-

ican Thoracic Society (ATS); smoking history of greater than 10

pack-years, and FEV1/FVC ratio <70%. McGlone 2004 partici-

pants also had to fit the criteria: aged more than 50 years. Both

Watson 1997 and McGlone 2004 also required a FEV1 <65% of

predicted. McGeoch 2004 also stated inclusion criteria of symp-

toms at least weekly and history of one or more exacerbations in

the previous 12 months requiring an increase in therapy. Entry

criteria for Watson 1997 included current use of bronchodilator

therapy.



In all studies nursing home residents were excluded. Watson 1997

and McGeoch 2004 had additional exclusion criteria, including

primary diagnosis of asthma (onset <35 years). Watson 1997 spec-

ified a primary diagnosis of cardiac disease (uncontrolled heart fail-

ure), primary or secondary diagnosis of another functionally lim-

iting disease (except cor pulmonale) that could significantly affect

either patient mortality within six months of entry to the study

or participation in the study, and continuous use of oral corticos-

teroid or long-term antibiotic therapy as exclusion criteria. Mc-

Geoch 2004 excluded participants with another primary limiting

disease, another medical condition likely to affect patient mortal-

ity, if already using a self-management plan, on domiciliary oxy-

gen, attending a GP that used self-management plans more than

occasionally, exacerbation of COPD requiring increased treatment

within six weeks or admission to a general hospital within three

months, cognitive impairment, alpha1 antitrypsin deficiency, or

being unable or unwilling to sign consent form.

In McGlone 2004 patients were randomised using a computer

generated randomisation software package at the general practice

level so that all participants from individual practices were given

the same intervention. Randomisation in Watson 1997 was gen-

erated via a computer in blocks of ten. Allocation concealment

grades were B for both trials. In McGeoch 2004, the GP practices

were randomised by one of the investigators, and if there were

too many patients identified in each practice, a random numbers

table was used to allocate individual patients. The allocation con-

cealment in this trial was thus B. One aspect of concern with this

method is that if the same GP is implementing both intervention

and usual care there may confounding between treatment meth-

ods, possibly diluting the effects of active intervention.

The interventions in Watson 1997, McGeoch 2004 and McGlone

2004 all involved the use of an action plan and an information

booklet. McGlone 2004 participants also received an individual

education session with a nurse experienced in managing respi-

ratory disease. Their action plan was a written self-management

plan that was developed in consultation with their treating GP. It

listed the patient’s maintenance medications and an individualised

action plan based on the early recognition of symptoms associ-

ated with exacerbations of COPD. Seventy six per cent received

a standard action plan with instructions to self-initiate a short-

course of oral corticosteroids and an antibiotic, whilst the other

24% received an action plan with instructions to either initiate an-

tibiotics only (n=10), double their dose of inhaled corticosteroids

and commence an antibiotic (n=2), initiate a short course of oral

corticosteroids only (n=1) or to contact their GP (n=3). Those

action plans that involved self-initiation of medication were given

prescriptions by their GP. All intervention participants were en-

couraged to present early to their GP.

The action plans used in Watson 1997 and McGeoch 2004 were

exactly the same and provided advice on management of usual care

and exacerbations, together with a booklet on self-management, a

prescription for prednisolone and a broad spectrum antibiotic for

self-administration during an exacerbation from their GP. Watson

1997 made no attempt to individualise the instructions in the

action plan, whereas standardised self-management plan education

was delivered in an individual session from a practice nurse or

respiratory educator in association with the participant’s GP in the

McGeoch 2004 trial.

Booklets were supplied with action plans that covered the topics of

smoking cessation, controlling breathlessness, nutrition, exercise,

clearing mucus from the lungs, medications, and contact details of

community support services. Watson 1997 and McGeoch 2004

also covered other topics; daily activities made easier, sleep, plan-

ning for the future, and oxygen therapy. McGlone 2004 also in-

cluded the basic pathology of COPD, immunisations, stress man-

agement, and the correct use of inhalers.

All control groups were provided with usual care, and although

this varied between studies they were always specifically denied

access to the action plan. In McGlone 2004, usual care included

provision of a booklet and an individual nurse education session. In

McGeoch 2004, non-standardised education according to routine

practice at the time was provided and in Watson 1997 there was

no educational intervention.

Outcome measures in the McGlone 2004 study were assessed at

baseline, 3, 6, 9, and 12 months. The 6 and 12 month assessments

were face-to-face at the GPs surgery or patient’s home, whilst the 3

and 9 month were done using a standardised telephone interview.

Demographics, smoking and symptom history, medications used

as maintenance and treatment over the preceding 12 months were

obtained at baseline from a standardised questionnaire. Height,

weight and spirometry were recorded at baseline, 6 and 12 months.

In Watson 1997 outcomes were measured at 6 and 12 months, and

reported as absolute means and standard deviations from baseline.

Both studies assessed HRQoL via SGRQ at baseline and six

months. However, Watson 1997 reported absolute mean and stan-

dard deviation, whilst McGlone 2004 reported mean change and

standard deviation at 6 and 12 months after having reported ab-

solute mean and standard deviation at baseline.

Other outcome measures assessed by McGlone 2004 included

physical activity over 7 days using a digital pedometer at baseline, 6

and 12 months; a diary record for use of antibiotics, short courses

of oral steroids, number of GP consultations, hospitalisations, and

attendances at emergency departments. Diary cards and smoking

status were reviewed at three monthly intervals.

Other outcome measures assessed by Watson 1997 included daily

diary cards which rated respiratory status as usual, mild, mod-

erate, or severe; prednisone use, antibiotic use, and contact with

GP, PN, hospital specialist, pharmacist. Subjects were interviewed

about access to and use of treatments, services and self-manage-

ment strategies. FEV1 and FVC were measured with a spirom-

eter. Application of outcome measures were delayed if subjects



had received a course of prednisone or antibiotics in the preced-

ing 21 days. McGeoch 2004 included study visits at baseline and

12 months, with telephone interviews at 3, 6, and 9 months. At

6 and 12 months the SGRQ, healthcare utilisation and medica-

tion scores were recorded. HADS was recorded at baseline and 12

months. The absolute COPD-SMI was recorded at 12 months.

Any missing data was addressed by contacting the author for ad-

ditional information. If there was no reply on the first occasion a

second attempt was made.

M E T H O D O L O G I C A L Q U A L I T Y

The allocation concealment grade for all studies was B, interpreted

as concealment being unclear. In Watson 1997, the randomisa-

tion list was available to the person recruiting the GPs and par-

ticipants, but not the participants or GPs themselves who found

out upon beginning the programme. In McGlone 2004, GPs were

randomised and aware of the arm they were randomised to. In

McGeoch 2004, the GP practices were randomised by one person

and if there were too many patients identified in each practice a

random numbers table was used to allocate individual patients.

None were double blind due to the nature of the study making it

impossible. A description of withdrawals and dropouts was given

in all studies.

R E S U L T S

INCLUSION

The searches identified a total of 199 titles and abstracts that

were screened to identify potential relevance to the topic of action

plans in COPD. Eleven studies appeared relevant to the review

and two reviewers (AT and JW) assessed them independently. Of

these, two are ongoing (Brightling; Sweeney 2002), two are com-

pleted but data could not be obtained either in published form

or from the investigators (Prigmore 2001; Wellingham 2002) and

four were excluded. Two were not randomised controlled trials

(Dhein 2003; Parenteau 2003) and two were comprehensive pro-

grammes in which the action plan component could not be iso-

lated (Bourbeau 2004; Worth 2004). Three articles were included

in the meta-analysis (McGeoch 2004; McGlone 2004; Watson

1997).

MISSING DATA

Authors were contacted twice via e-mail to request missing data.

Those listed in the acknowledgment section replied and were able

to provide requested information. Replies were not received from

two ongoing studies nor one full-text article.

INTERVENTIONS

All studies compared action plans with usual care, and all also

used an information booklet. McGeoch 2004 and Watson 1997

used the same action plan, whilst McGlone 2004 used a slightly

more personalised action plan for the patients. Education provided

with action plans included an individual education session with a

health-care worker in McGlone 2004 and McGeoch 2004, and an

unstandardised introduction to action plans upon presentation of

the action plan in Watson 1997. Follow-up time in Watson 1997

was six months, whilst in McGeoch 2004 and McGlone 2004 it

was 12 months. McGlone 2004 also recorded some outcomes at

six months.

COMPARISONS

All included studies used an action plan as the active intervention

and this was specifically denied to participants in the control group.

SUBJECTS/RECRUITMENT

A total of 367 patients were randomised in the three studies; 320

completed the studies. The drop out rate ranged from 4.4% to

18.8%.

All studies recruited from GP clinics. McGeoch 2004 recruited

additional participants from prescription databases, searching for

bronchodilator and inhaled corticosteroid prescriptions.

HETEROGENEITY AND SENSITIVITY ANALYSIS

No heterogeneity was identified. Nothing was revealed in sensi-

tivity analysis.

OUTCOMES

Number of studies reporting the outcome is given in brackets:

Primary outcomes:

A1. Hospital admission (3)

A2. Healthcare utilisation (3) specifically: scheduled and unsched-

uled GP visits; treatment in an emergency department.

A3. Use of medications (3) specifically: number of courses/days

of antibiotic and/or steroid use; number of participants initiating

antibiotic and/or steroid use

Secondary outcomes:

B1. Number of acute exacerbations (0)

B2. Length of exacerbations (0)

B3. HRQoL (3)

B4. Lung function (2)

B5. Functional capacity (1)

B6. Symptom scores (1)

B7. Mortality (2)

B8. Days lost from work (0)

Additional outcomes reported:

C1. Anxiety and depression (1)

C2. Self management knowledge(1)

A1. HOSPITAL ADMISSION

In McGeoch 2004 8% of the intervention group and 9% of the

usual care group had one or more hospital admissions over 12

months. In McGlone 2004 the mean number of hospital admis-

sions over 12 months was 0.5 (SD 0.8) for the intervention group

and 0.3 (SD 0.7) for the usual care group. Pooling the data found

no evidence of a significant effect of active intervention for this



outcome: weighted mean difference in number of admissions over

12 months from two studies was 0.16; 95% confidence interval

-0.09 to 0.42.

A2. HEALTHCARE UTILISATION

No significant difference in healthcare utilisation was seen between

groups for any type of healthcare utilisation:

Number of visits to GP or practice nurse in six months, WMD

1.00; 95% confidence interval -0.57 to 2.57 (two studies)

Number of scheduled visits to GP in 12 months, mean difference

-0.50; 95% confidence interval -4.06 to 3.06 (one study)

Number of emergency visits to GP for COPD in 12 months,

mean difference -0.20; 95% confidence interval -1.55 to 1.15 (one

study)

Number of emergency department visits in 12 months, WMD

-0.01; 95% confidence interval -0.12 to 0.10 (two studies)

A3. USE OF MEDICATIONS

The use of medications was reported in a variety of ways. Watson

1997 measured use of medications over six months and showed

a significant increase in the use antibiotics by the group using an

action plan. The mean difference in number of days on antibi-

otics was 6.00 days; 95% confidence interval 1.4 to 10.6, and

the Peto odds ratio for the initiation of corticosteroid was 6.51;

95% confidence interval 2.02 to 21.05. The difference between

groups was not as clear cut for oral corticosteroid use. The num-

ber of days on corticosteroids was not statistically significant be-

tween groups, mean difference 6.00 days; 95% confidence interval

-5.53 to 17.53, while the number of participants initiating corti-

costeroids was, Peto odds ratio 4.85; 95% confidence interval 1.37

to 17.21. McGlone 2004 and McGeoch 2004 both reported this

outcome using continuous data over 12 months, which could be

combined. There was no significant difference in medication use

for either antibiotics over 12 months; WMD 0.14 courses, 95%

confidence interval -0.20 to 0.48 or for oral corticosteroids over

21 months; WMD 0.35 courses, 95% confidence interval -0.17

to 0.88. The large weight allocated to McGeoch 2004 (94.76%)

is due to the small confidence interval. Attempts were made to

combine use of medications across all three trials, but the available

data did not permit this.

B1. NUMBER OF ACUTE EXACERBATIONS

None of the studies included measured the number of acute exac-

erbations using criteria such as those of Seemungal 2000, which re-

quires an increase in two of the “major symptoms”; dyspnoea, spu-

tum volume or sputum purulence, or one of these with an increase

in one “minor symptom” for two days (wheeze, sore throat, cough

or common cold symptoms). While McGlone 2004 reported that

83% of the intervention group and 67% of the usual care group

were treated for an exacerbation of COPD during 12 months, and

this difference was statistically significant, Peto odds ratio 2.44;

95% confidence interval 1.14 to 5.23, it should be borne in mind

that using treatment of an exacerbation as a surrogate for the total

number may underestimate the frequency as up to 40% are not

be reported to a health care provider ( Wilkinson 2004).

B2. LENGTH OF EXACERBATIONS

No studies reported this outcome

B3. HRQoL

Health-related quality of life was measured using the COPD-spe-

cific St George’s Respiratory Questionnaire (SGRQ) in all studies.

We combined the results from Watson 1997 and McGlone 2004.

At six months there were no statistically significant differences be-

tween groups for HRQoL.

Overall score: WMD -1.91; 95% confidence interval -5.46 to 1.63

Symptoms: WMD -4.78; 95% confidence interval -10.81 to 1.24

Activity: WMD -2.43; 95% confidence interval -7.37 to 2.50

Impacts: WMD -0.62; 95% confidence interval -4.45 to 3.21

Combining results from McGlone 2004 and McGeoch 2004 at 12

months also showed no statistically significant difference between

groups for HRQoL.

Overall score: WMD -0.32; 95% confidence interval -3.34 to 2.70

Symptoms: WMD 1.87; 95% confidence interval -3.27 to 7.00

Activity: WMD -2.82; 95% confidence interval -6.84 to 1.19

Impacts: WMD 1.16; 95% confidence interval -2.21 to 4.53

B4. LUNG FUNCTION

There were no statistically significant differences between inter-

ventions in lung function at either 6 or 12 months.

FEV1 ml at six months: mean difference 50.00 ml; 95% confi-

dence interval -29.86 to 129.86 (1 study)

% predicted FEV1 at six months: WMD 1.83 %; 95% confidence

interval -1.05 to 4.71 (2 studies)

FEV1 ml at 12 months: mean difference 43.00 ml; 95% confi-

dence interval -63.30 to 149.30 (1 study)

% predicted FEV1 at 12 months: mean difference 2.00 %; 95%

confidence interval -1.89 to 5.89 (1 study)

B5. FUNCTIONAL CAPACITY

Functional capacity was recorded in the McGlone 2004 study as

physical activity steps/day. No significant difference was found.

B6. SYMPTOM SCORES

There were no statistically significant changes in symptom scores

in the one study reporting this outcome Watson 1997. The mean

difference in the number of days with respiratory symptoms in

six months was -16.00 days; 95% confidence interval -45.65 to

13.65. Subjects breathing status was recorded in symptom diaries

on a four point scale (usual, mild, moderate, severe). There were

no significant differences in the percentage of days recorded as

mild, moderate or severe. Both groups had 8% of days in which

breathing was recorded as “severe”.

B7. MORTALITY

The difference in mortality was not statistically significant, Peto

odds ratio at 12 months 1.01; 95% confidence interval 0.32 to

3.24 McGeoch 2004; McGlone 2004.



B8. DAYS LOST FROM WORK

No studies reported this outcome

C1. ANXIETY AND DEPRESSION

No statistically significant differences between groups were found

in McGeoch 2004 using the HADS. The mean difference for

anxiety was 0.14; 95% confidence interval -1.66 to 1.94 and for

depression was 0.25; 95% confidence interval -0.59 to 1.09.

C2. SELF MANAGEMENT

Using a standardised COPD self management questionnaire, Mc-

Geoch 2004 showed a statistically significant difference in partic-

ipants’ knowledge favouring the action plan group. For recogni-

tion of when respiratory health is stable, the mean difference was

1.10; 95% confidence interval 0.46 to 1.74; for recognition of an

early exacerbation the mean difference was 1.80; 95% confidence

interval 0.75 to 2.85 or a severe exacerbation, mean difference

2.50; 95% confidence interval 1.04 to 3.96. There was also a sta-

tistically significant difference for knowledge on how to act when

each of these states of health is being experienced, again favouring

the action plan group. The mean difference when well was 0.50;

95% confidence interval 0.21 to 0.79, for an early exacerbation

was 2.30; 95% confidence interval 0.96 to 3.64 and for a severe

exacerbation was 1.50; 95% confidence interval 0.62 to 2.38. This

study shows patients have a better knowledge of the importance of

early intervention, and how to implement appropriate treatment

for an exacerbation if they are provided with an action plan.

D I S C U S S I O N

This paper systematically reviewed the literature comparing action

plans to usual care for COPD. From the three studies included,

there was no evidence of effect on healthcare utilisation, HRQoL,

lung function, functional capacity, symptom scores, mortality,

anxiety and depression. Evidence of a positive effect was seen in

one primary (medication usage) and one additional outcome (self-

management). The number of exacerbations, length of exacerba-

tions, and days lost from work were not recorded outcomes in any

of the trials.

For the primary outcomes, hospital admissions showed no signif-

icant difference between interventions. The two studies involved

in this analysis moved in opposite directions and interpretation of

the mean difference, 0.16 per year; 95% confidence interval -0.09

to 0.42, is unclear. Similarly, other healthcare utilisation showed

no statistical differences for the number of emergency GP visits

or visits to the emergency department . However, for the final pri-

mary outcome, a statistically significant increase in medication use

was seen favouring the action plan group. We suggest this repre-

sents an appropriate response to recognition of an acute exacerba-

tion, given that the active interventions in the studies were to ini-

tiate treatment with antibiotics and/or corticosteroids (McGeoch

2004; McGlone 2004), or subjects were supplied with these drugs

for use (Watson 1997). Further evidence to support the argument

that this represents a positive outcome for action plans is seen

in the McGeoch 2004 cluster trial, in which a greater ability to

recognise and appropriately react to symptoms suggesting an ex-

acerbation, was seen in the action plan arm. Given that there is ev-

idence from a systematic review that treatment of an exacerbation

of COPD with oral steroids reduces the risk of treatment failure,

improves FEV1 and breathlessness (Wood-Baker 2003) and that

oral steroids shorten the time to recovery from an exacerbation

(Seemungal 2000), it is disappointing that there was no evidence

that this translated into positive effects on other outcomes, and

questions whether action plans impact significantly upon patients’

health status. While an increased use of antibiotics and steroids

suggests greater self-initiation of medications as part of an action

plan, this also exposes patients to adverse effects including an in-

crease in bacterial resistance, and side effects of the drugs e.g. os-

teoporosis, which were poorly reported in all studies. Although

confounding is a potential problem in the Watson 1997 study, due

to self-selection of GPs with an interest in COPD who may be

more likely to treat severe COPD with antibiotics or prednisone

in the absence of an action plan, this should have been overcome

by the use of cluster randomisation in the later McGlone 2004

and McGeoch 2004 trials.

For secondary outcomes, neither the number or length of exacer-

bations were reported directly. HRQoL showed no significant dif-

ference in either the total or any sub-category at 6 or 12 months.

This absence of a difference between interventions in HRQoL was

mirrored by lung function and physical activity in the McGlone

2004 study. Given the known associations between lung func-

tion, HRQoL and physical activity, the absence of an improve-

ment in HRQoL without associated changes in other outcomes,

is not surprising. The decreased physical activity of both interven-

tion groups seen in McGlone 2004 study could be due to progres-

sion of COPD over the 12 months, unlikely given the stable lung

function, or be the result of other factors such as seasonal weather

variation. It is not impossible that the 6 and 12 month scores may

have been recorded in summer and winter months, accounting for

the changes in physical activity scores.

All the studies included in this review had methodological limita-

tions. None of the three studies achieved a grade A allocation con-

cealment, which highlights the main limitation. However, alloca-

tion concealment was traded off against potential confounding by

contamination within GP groups in the two later studies, after this

had been identified as an issue by Watson 1997. Although Mc-

Geoch 2004 reported undertaking cluster randomisation of GPs,

further information revealed that if the numbers of individuals

participating in the study were too large for the practice involved,

the individuals were then randomised via a random numbers ta-

ble. This effectively defeats the purpose of cluster randomisation

to reduce contamination.

Most of the reported outcomes were small and did not reach statis-



tical significance. This may reflect small numbers of participants

in each study and/or the ability to statistically combine many of

the outcomes in a meta-analysis. But the presence of a positive ef-

fect for some outcomes supports the contention that action plans

can alter patient actions, as has been demonstrated with asthma

patients. Whether larger numbers of subjects contributing data to

healthcare outcomes will subsequently demonstrate small benefits

in resource utilisation remains to be seen. To find a statistically sig-

nificant difference between interventions for the mean differences

would require large increases in sample sizes. Power calculations

indicate the numbers required to show statistically significant dif-

ferences between group are: 160 for hospitalisation, 746 for emer-

gency visits to the GP and 1970 for emergency department visits.

However, there is further evidence to support the use of action

plans in COPD from a retrospective cohort study which identified

reduced hospitalisation with the use of an action plan (0.8/patient)

compared to a control group (1.3/patient) (Parenteau 2003).

The results from this review show that action plans provide an

approach to the management of acute exacerbations of COPD

which increases patients self-efficacy and their use of oral antibi-

otics and corticosteroids. To date this has not shown any signif-

icant reduction in the use of healthcare resources, change in the

participants physiology or improved clinical outcomes. While the

lack of evidence to support the role of the action plan in COPD

management should not be necessarily seen as the evidence of lack

of efficacy, at this time a written action plan without a broader self-

management plan cannot be recommended for widespread adop-

tion in primary care.

A U T H O R S ’ C O N C L U S I O N S

Implications for practice

The data included in this review shows that the use of action plans

aids the COPD patient to recognise and respond to their exacer-

bations through the self-initiation of medication. The data in this

review is not sufficient, however, to draw clinical recommenda-

tions regarding the use of action plans in COPD, as the number

of studies and variability in published outcomes does not demon-

strate any significant change in clinical outcomes or use of health-

care resources.

Implications for research

This review highlights the need for continued research into the

use of action plans in COPD, to increase the number of studies

and study participants in outcomes so that the evidence can either

show benefit or provide evidence of no effect. The action plan may

need to be refined for optimal use by COPD patients.

P O T E N T I A L C O N F L I C T O F

I N T E R E S T

One reviewer (RWB) was an investigator in an included study

(McGlone 2004).

A C K N O W L E D G E M E N T S

Toby Lasserson- helped with the overall construction of the review

Chris Cates- shared with us his statistical knowledge

The following people conversed with us over articles for inclu-

sion, exclusion, and those still in progress- Elizabeth Arnold, Jean

Bourbeau, Michael Epton, Robyn Maguigan, Samantha Prigmore,

Harry Rea, Ian Town, Paul Watson, John Wellingham

S O U R C E S O F S U P P O R T

External sources of support

• Commonwealth Department of Health and Aging AUS-

TRALIA

Internal sources of support

• University of Tasmania AUSTRALIA

R E F E R E N C E S

References to studies included in this review

McGeoch 2004 {unpublished data only}

McGeoch GR, Willsman KJ, Dowson CA, Town GI, Frampton CM,

McCartin FJ, et al. Self-management plans in the primary care of

patients with COPD.

McGlone 2004 {unpublished data only}∗ McGlone S, Wood-Baker R, Walters EH. The effect of a written

action plan in COPD [Abstract]. Respirology 2004;9(2 Suppl):A46.

Watson 1997 {published data only}∗ Watson PB, Town GI, Holbrook N, Dwan C, Toop LJ, Drennan

CJ. Evaluation of a self-managment plan for chronic obstructive pul-

monary disease. European Respiratory Journal 1997;10:1267–71.

References to studies excluded from this review

Bourbeau 2004

Bourbeau J, Nault D, Dang-Tan T. Self-management and behaviour

modification in COPD. Patient Education & Counseling 2004;52:

271–7.

Dhein 2003

Dhein Y, Munks-Lederer C, Worth H. Evaluation of a structured

education programme for patients with COPD under outpatients



conditions - a pilot study. Medizinische Klinik 2003;57:591–7.

Parenteau 2003∗ Parenteau S, Scott AS, McKnight J, Menzies D, Bourbeau J. Im-

pact of an action plan that emphasizes the prompt use of oral pred-

nisone and antibiotics in COPD exacerbation [Abstract]. American

Thoracic Society 99th International Conference. 2003:A108 [Poster:

C62].

Worth 2004∗ Worth H, Dhein Y. Does patient education modify behaviour in

the management of COPD?. Medizinische Klinik 2004;52:267–70.

References to ongoing studies

Brightling

Brightling C. Self management in chronic obstructive pulmonary

disease: an approach to reduce the need for hospital admission.

Prigmore 2001

Prigmore S. Does an individualised self-management plan help pa-

tients with chronic obstructive pulmonary disease (COPD) initiate

early treatment for infective exacrebations?.

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∗Indicates the major publication for the study

T A B L E S

Characteristics of included studies

Study McGeoch 2004

Methods Trial type: RCT

Control: usual care

Blinding: nil

Dropouts/Crossovers: Intervention=1death, 1 withdrew consent; control=2 deaths, 2 wtihdrew consent, 1

unable to be contacted

Co-interventions:

Duration of use: 12 months

Participants Diagnosis: COPD according to ATS criteria (history of cough, sputum, SOB, >10y pack smoking); plus

FEV1/FVC<70%, weekly symptoms, history or 1+ exacerbations in previous 12 months requiring increase

in therapy.

No. eligible: 257 screened

No. Randomised: 159

No. Completed: 152

Age: int 69.8(11.6); control 72.1(9.9)

Male:Female: M 52% int; 67% cont

COPD severity: Moderate

Smoking history: >10 pack years



Characteristics of included studies (Continued )

Recruitment Centre: GP practices, also searched prescription databases for bronchodilator and inhaled

corticosteroid prescriptions to increase number patients screened.

Major exclusions: Unable/unwilling to sign consent, primary diagnosis asthma, other primary functionally

limiting disease, other medical condition likely to affect patient mortality, hospital level residential care,

already using self-management plan, on domicillary O2, attending GP that already uses self-managment plans

more than occasionally, exacerbation of COPD requiring increased treatment within 6 weeks or admission to

general hospital within 3 months, cognitive impairment as per 3MS of <75%, alpha1 antitrypsin deficiency.

Interventions Description AP intervention: usual care, and individual standardised education session from practice nurse

or respiratory educator on the use of a self-management plan which includes methods of early recognition

of exacerbations and appropriate self-initiated interventions including antibiotics and short-course oral cor-

ticosteroids; instruction to make early contact with GP

Description Control: Usual care, specifically denied access to written self-management plan.

Number interventions:84

Number controls: 73

Outcomes Length of times followed up: 12 months

Year study performed: July 2002-Dec 2003

Medications: % people used courses of antibiotics and oral steroids at 6 and 12 months

HRQoL: SGRQ measured at 6 and 12 months

Helathcrae utilisation: % of participants who attended GP visits, ED visits, and hospital admissions at 6 and

12 months

% who took courses of antibiotics/prednisone at 12 months

Hospital Anxiety and Depression Scale (HADS)

COPD-SMI at 12 months

Notes Note no method of randomisation and no details of allocation concealment are given.

Non-standard education on smoking cessation, exercise, controlling breathlessness, nutrition, use of inhaled

therapy and immunisation were given according to practice standards

Allocation concealment B – Unclear

Study McGlone 2004


Control: routine care, specifically denied AP

Blinding:

Dropouts/Crossovers: Intervention group: 5 deaths; 8 withdrawals. Control Group: 4 deaths; 8 withdrawals;

2 lost to follow-up.

Co-interventions:

Duration of use: 54 in intervention group and 58 in control group completed 12 months.

Participants Diagnosis:COPD as primary functionally limiting illness, aged >50yo, tobacco smoking history >10pack

years, and either a FEV1<65% and/or a FEV1/FVC<70%

No.eligible:262

No. Randomised: 139

No. completed: 112

Age: Intervention 69+/-7.8; Control 71+/-8.4 years

Male:Female: Intervention 49 males, 18 female; control 67 males, 5 females

COPD severity: Intervention FEV1%pred 46.3+/-16, FEV1/FVC 56.8+/-15.7; Control FEV1% pred 44.2+

/-15.8, FEV1/FVC 50.9+/-12.2

Smoking history: Intervention 55+/-26 pack years; control 59+/-33.7pack years. 1 intervention and 2 controls

ceased smoking during study. 2 in intervention group recommenced.

Recruitment centre: All GPs registered with Southern Tasmanian Divisio nof General Practitioners (n=255)

contacted and invited to participate.

Major exclusions: Nursing home residents.




Intervention characteristics: n=67: Age 69+/-7.8; 49 males; 46 married, 37 widowed; 12 separated/divorced;

5 never married; 40 labourers; 19 clerical, sales and service industry workers; 16 tradespersons; 11 managers,

admin and professional workers; 9 production and transport; 5 never worked; 36 current smokers; 55+/-26

pack year smoking history; BMI 25.9+/-5.8;

Control characteristics: n=72: Age 71+/-8.4; 67 males; 51 married, 33 widowed; 10 separated/divorced; 6

never married; 27 labourers; 28 clerical, sales and service industry workers; 27 tradespersons; 11 managers,

admin and professional workers; 7 production and transport; 0 never worked; 22 current smokers; 59+/-33.7

pack year smoking history; BMI 25.2+/-5.4;

Intervention Group: FEV1=1.1+/-0.5; FEV1% pred= 46.3+/-16; FEV1/FVC= 56.8+/-15.7; Daily steps 4751

(IQR 4473); SGRQ symptoms-59.9+/-22.7, activity-62.3+/-25.2, impacts 33.4+/-21.3, total 46.5+/-20.4;

Participation in pulmonary rehab 30; medications prescribed at enrolment: SABA 97, LABA 36, ipratropim

67, methylxanthine 8, inhaled corticosteroid 60, oral corticosteroid 8, O2 10.

Control group: FEV1=1.1+/-0.4; FEV1% pred=44.2+/-15.8 ; FEV1/FVC=50.9+/-12.2 ; Daily steps

3454(IQR=3041); SGRQ symptoms-62.7+/-20.6, activity-66.4+/-20.2, impacts 32.1+/-17.3, total 47.3+

/-16.6; Participation in pulmonary rehab 24; medications prescribed at enrolment: SABA 78, LABA 24,

ipratropim 57, methylxanthine 7, inhaled corticosteroid 43, oral corticosteroid 7, O2 4.

Interventions Description AP intervention: COPD info booklet and individual educational session with resp nurse (covered

basic COPD pathology, smoking cessation, immunisations, nutrition, exercise, clearing mucus from lungs,

controlling breathlessness during ADLs, stress management, medications, correct use of inhalers and contact

details of community support services). Also written self-management plan listing maintenance medications

and individual AP based on early recognition of exacerbations. 76% patients got instructions to start short

course oral corticosteroids and an antibiotic; remaining 24% received instructions to initiate antibiotics only

(n=10), double dose inhaled corticosteroids and start antibiotic (2), initiate short course oral corticosteroids

only(1), or contact GP(3). Prescriptions were provided as necessary. All were encouraged to present to GP

early during exacerbation.

Description control: Usual care, specifically denied action plan

Number interventions: 54

Number controls: 58

Outcomes Length of times followed up: 3, 6, 9, 12 months, 6 and 12 at GP, 3 and 9 using standard telephone interviews

Year study performed: 2002

No. exacerbation:

Medications: diary to record antibiotic use, short course corticosteroidsused

HRQoL: change score SGRQ at 6 and 12 months

Healthcare utilisation:diary used to record GP consults, hospitalisations and attendences to ER

Lung Function:

Functional capacity: physical activity assessed at baseline, 6 and 12 months using digital pedometer.

Symptom scores:

Mortality:

Days lost from work:

Notes


Study Watson 1997


Control: usual care; specifically denied access to AP and booklet

Blinding: nil

Dropouts/Crossovers: 13: 4 offended by questionnaire; 3 experienced complications from concurrent medical

problems; 3 felt study protocol too demanding; 1 left country;2 died.

Co-interventions: usual care

Duration of use: 6 months




Participants Diagnosis: COPD defined according to American Thoracic Society: diagnosis of COPD as major function-

ally limiting disease; smoking history >10 pack-years; FEV1<65%;FEV1/FVC<70%; current use of bron-

chodilator therapy.

No.eligible: 93 patients screened for possible inclusion; 24 did not meet inclusion criteria so 69 enrolled

No. Randomised: 69 enrolled

No. completed: 56

Age: mean age 68 years

Male:Female: 62% male

COPD severity:

Smoking history: must’ve had 10 pack-year history

Recruitment centre: 12 practices involving 22 GPs

Major exclusions: Primary diagnosis of asthma (onset<35yo), primary diagnosis of cardiac disease (uncon-

trolled heart failure); primary or secondary diagnosis of another functionally limiting disease (except cor

pulmonale) that could signif affect patient mortality within 6 months of entry to the study (malignant neo-

plasm) or participation in the study (psychoses); continuous use of oral corticosteroid; long-term antibiotic

therapy; and rest-home residents.

Intervention characteristics: Age 68(10);Male 62%;married52%; current smoker24%; FEV%pred 37(14);

access to nebulizer 17%; own a peak flow meter 76%; influenza vaccine in last year 72%

Control characteristics: Age 67(8), male67%; maried37%; current smoker33%; FEV1%pred 36(16); access

to nebulizer 26%; own a peak flow meter 70%; influenza vaccine in last year 44%

Intervention Group: Days in study:186(13); days recorded on symptom diary144(62); breathing recorded

as usual 56%(37);mild18%(19); moderate17%(24); severe 8(21); days on antibiotics 10(11); days on pred-

nisolone 15(22); visits to GP or PN 3(3)

Control group: Days in study:187(7); Days recorded on symptom diary 160(51); Breathing recorded as usual

51%(37);mild 21%(24); moderate 20%(26); severe 8(13); days on antibiotics 4(6); days on prednisolone

9(22); visits to GP or PN 2(3)

Interventions Description AP intervention: advice on management of usual care and exacerbations, and a booklet on

self-management; supply of prednisone and antibiotic from GP. Booklet ’A guide to living positively with

COPD’ was developed and circulated among patients GPs and family. Covered smoking cessation, controlling

breathlessness, exercise, daily activities, diet, sleep, clearin mucus, planning for future, medications, O2 and

contact details for support services

Description control: usual care

Number interventions:29

Number controls: 27

Outcomes Length of times followed up: 6 months

Year study performed: 1994

HRQoL: Used absolute SRGQ

Healthcare utilisation:

Lung Function:

Functional capacity:

Symptom scores:

Mortality:

Days lost from work:

Days on antibiotics/prednisone

Notes


Characteristics of excluded studies

Bourbeau 2004 Was not possible to extract outcome data in regard to AP only.

Dhein 2003 Not RCT.



Characteristics of excluded studies (Continued )

Parenteau 2003 Not RCT.

Worth 2004 Was not possible to extract outcome data in regard to AP only.

Characteristics of ongoing studies

Study Brightling

Trial name or title Self-management in chronic obstructive pulmonary disease: an approach to reduce the need for hospital ad-

mission.

Participants

Interventions

Outcomes

Starting date Jan 8 2001

Contact information [email protected]

Notes No reply received when contacted

Study Prigmore 2001

Trial name or title Does an individualised self-management plan help patients with chronic obstructive pulmonary disease (COPD

initiate early treatment for infective exacerbations?

Participants 40-20; diagnosis of COPD attending the nurse-led clinic at St.George’s Helathcare NHS Trust

Interventions Education, issuing of a self-management leaflet, symptom card and a prescription for antibiotics and cortico-

steroids

Outcomes See if individualised self-management plan improves patients ability to recognised early signs of an infection

and self initiate treatment during an exacerbation.

Starting date Jan 1 2004

Contact information Ms Samantha Prigmore

Chest Medicine

St George’s Hospital Medical School

Blackshaw Road

Tooting

London

SW17 0RE UK

[email protected]

Notes To be completed end of September 2004

Study Sweeney 2002

Trial name or title COPD - education & self-management intervention

Participants 20; from Chest Clinic

Interventions 30 minute education and issuing of a self-management plan

Outcomes Measured via COPD self efficacy questionairre, 15 MCQs on knowledge of self-management plan; questionnaire

on views of self-management plan; group discussion of self-management plan.

Starting date Nov 30 2002

Contact information Pam Sweeney

Outreach Service

Birmingham Heartlands & Solihull NHS Trust (Teaching)

Bordesley Green Road



Characteristics of ongoing studies (Continued )

Bordesley Green East Birmingham

B9 5SS’

UK

Ph: 01214240186

email: [email protected]

Notes No reply received when contacted

Study Wellingham 2002

Trial name or title Reducing hospital demand through a single chronic disease management programme for COPD and associated

co-morbidity [Abstract]

Participants 138

Interventions

Outcomes dyspnoea rating, spirometry, shuttle walk test, SF-36, and chronic respiratory questionnaire

Starting date June 2002

Contact information [email protected]

Notes Definitive article to be published in Internal Medicine Journal, hopefully in Sept/Oct 2004.

A N A L Y S E S

Comparison 01. Action Plan versus usual care

Outcome titleNo. of

studies

No. of

participants Statistical method Effect size

01 Number of admissions to

hospital in 12 months

2 WMD (Fixed) 95% CI 0.16 [-0.09, 0.42]

02 Visits to GP/PN in 6 months 1 56 Weighted Mean Difference (Fixed) 95% CI 1.00 [-0.57, 2.57]

03 Number scheduled GP visits in

12 months

1 Mean Difference (Fixed) 95% CI -0.50 [-4.06, 3.06]

04 Number emergency visits to

GP for COPD in 12 months

1 Mean difference (Fixed) 95% CI -0.20 [-1.55, 1.15]

05 Number of total GP visits in

12 months

1 Mean difference (Fixed) 95% CI 0.07 [-0.28, 0.43]

06 Number of times treated in the

emergency department in 12

months

2 WMD (Fixed) 95% CI -0.01 [-0.12, 0.10]

07 Days on Antibiotics in 6

months

1 56 Weighted Mean Difference (Fixed) 95% CI 6.00 [1.40, 10.60]

08 Days on corticosteroids in 6

months

1 56 Weighted Mean Difference (Fixed) 95% CI 6.00 [-5.53, 17.53]

09 Patients initiating antibiotics in

6 months

1 56 Odds Ratio (Fixed) 95% CI 10.16 [2.02, 51.09]

10 Patients initiating steroids in 6

months

1 56 Odds Ratio (Fixed) 95% CI 6.58 [1.29, 33.62]

11 Courses of Antibiotics in 12

months

2 WMD (Fixed) 95% CI 0.14 [-0.20, 0.48]

12 Courses of oral corticosteroids

in 12 months

2 WMD (Fixed) 95% CI 0.35 [-0.17, 0.88]



13 Number of subjects with >=

1 exacerbation COPD with

antibiotics in 12 months

1 139 Peto Odds Ratio 95% CI 2.44 [1.14, 5.23]

14 Length of exacerbations 0 0 Weighted Mean Difference (Fixed) 95% CI Not estimable

15 SGRQ symptom scores at 6

months

2 WMD (Fixed) 95% CI -4.78 [-10.81, 1.24]

16 SGRQ activity scores at 6

months

2 WMD (Fixed) 95% CI -2.43 [-7.37, 2.50]

17 SGRQ impact scores at 6

months

2 WMD (Fixed) 95% CI -0.62 [-4.45, 3.21]

18 SGRQ total scores at 6 months 2 WMD (Fixed) 95% CI -1.91 [-5.46, 1.63]

19 SGRQ symptom scores at 12

months

2 WMD (Fixed) 95% CI 1.87 [-3.27, 7.00]

20 SGRQ activity scores at 12

months

2 WMD (Fixed) 95% CI -2.82 [-6.84, 1.19]

21 SGRQ impact scores at 12

months

2 WMD (Fixed) 95% CI 1.16 [-2.21, 4.53]

22 SGRQ total scores at 12

months

2 WMD (Fixed) 95% CI -0.32 [-3.34, 2.70]

23 FEV1 (mls) at 6 months 1 Mean difference (Fixed) 95% CI 50.00 [-29.86,

129.86]

24 FEV1 (mls) at 12 months 1 Mean difference (Fixed) 95% CI 43.00 [-63.30,

149.30]

25 FEV1 % predicted at 6 months 2 WMD (Fixed) 95% CI 1.83 [-1.05, 4.71]

26 FEV1 % predicted at 12

months

1 Mean difference (Fixed) 95% CI 2.00 [-1.89, 5.89]

27 FEV1/FVC at 6 months 1 Mean difference (Fixed) 95% CI -0.50 [-3.99, 2.99]

28 FEV1/FVC at 12 months 1 Mean difference (Fixed) 95% CI -0.30 [-4.50, 3.90]

29 Functional Capacity 0 0 Weighted Mean Difference (Fixed) 95% CI Not estimable

30 Number of days symptoms

recorded in 6 months

1 56 Weighted Mean Difference (Fixed) 95% CI -16.00 [-45.65,

13.65]

31 Days of breathing recorded as

usual in 6 months



mild in 6 months

1 56 Weighted Mean Difference (Fixed) 95% CI -3.00 [-14.39, 8.39]


moderate in 6 months

1 56 Weighted Mean Difference (Fixed) 95% CI -3.00 [-16.13,

10.13]


severe in 6 months


35 Mortality 2 298 Peto Odds Ratio 95% CI 1.01 [0.32, 3.24]

36 Days lost from work 0 0 Weighted Mean Difference (Fixed) 95% CI Not estimable

37 HADS anxiety 1 Mean difference (Fixed) 95% CI 0.14 [-1.66, 1.94]

38 HADS depression 1 Mean difference (Fixed) 95% CI 0.25 [-0.59, 1.09]

39 SMI well knowledge 1 Mean difference (Fixed) 95% CI 1.10 [0.46, 1.74]

40 SMI well actions 1 Mean difference (Fixed) 95% CI 0.50 [0.21, 0.79]

41 SMI early exacerbation

knowledge

1 Mean difference (Fixed) 95% CI 1.80 [0.75, 2.85]

42 SMI early exacerbation actions 1 Mean difference (Fixed) 95% CI 2.30 [0.96, 3.64]

43 SMI severe exacerbation

knowledge

1 Mean difference (Fixed) 95% CI 2.50 [1.04, 3.96]

44 SMI severe exacerbation actions 1 Mean difference (Fixed) 95% CI 1.50 [0.62, 2.38]



I N D E X T E R M S

Medical Subject Headings (MeSH)

Behavior Therapy; Health Promotion; Patient Care Planning; ∗Patient Education; Pulmonary Disease, Chronic Obstructive [∗therapy];

Randomized Controlled Trials; Recurrence; ∗Self Care

MeSH check words

Humans

C O V E R S H E E T

Title Action plans for chronic obstructive pulmonary disease

Authors Turnock AC, Walters EH, Walters JAE, Wood-Baker R

Contribution of author(s) A. Turnock:

Screened search results against inclusion criteria

Data management for the review

Grading of reviews

Data extraction

Analysis of data

Writing review

Updating review

J. Walters:

Grading of reviews

Data extraction

Advice on search strategy, data extraction and meta-analysis

Revision of review drafts

R. Wood-Baker:

Formulated review topic

Advice on search strategy, data extraction and meta-analysis

Revision of review drafts

E. Walters:

Editing protocol and review

Issue protocol first published 2004/3

Review first published 2005/4

Date of most recent amendment 25 August 2005

Date of most recent

SUBSTANTIVE amendment

23 July 2005

What’s New Information not supplied by author

Date new studies sought but

none found

Information not supplied by author

Date new studies found but not

yet included/excluded


Date new studies found and

included/excluded

01 August 2004

Date authors’ conclusions

section amended


Contact address Miss Allison Turnock



Medical Student

Discipline of Medicine

University of Tasmania Medical School

Discipline of Medicine, University of Tasmania

43 Collins Street

Hobart

Tasmania

7001

AUSTRALIA

E-mail: [email protected]

DOI 10.1002/14651858.CD005074.pub2

Cochrane Library number CD005074

Editorial group Cochrane Airways Group

Editorial group code HM-AIRWAYS

G R A P H S A N D O T H E R T A B L E S

Analysis 01.01. Comparison 01 Action Plan versus usual care, Outcome 01 Number of admissions to hospital

in 12 months

Review: Action plans for chronic obstructive pulmonary disease

Comparison: 01 Action Plan versus usual care

Outcome: 01 Number of admissions to hospital in 12 months

Study WMD (SE) WMD (Fixed) Weight WMD (Fixed)

95% CI (%) 95% CI

McGeoch 2004 -0.02 (0.32) 16.5 -0.02 [ -0.65, 0.61 ]

McGlone 2004 0.20 (0.14) 83.5 0.20 [ -0.08, 0.48 ]

Total (95% CI) 100.0 0.16 [ -0.09, 0.42 ]

Test for heterogeneity chi-square=0.38 df=1 p=0.54 I?? =0.0%

Test for overall effect z=1.26 p=0.2

-1.0 -0.5 0 0.5 1.0

Favours Action Plan Favours Usual Care



Analysis 01.02. Comparison 01 Action Plan versus usual care, Outcome 02 Visits to GP/PN in 6 months



Outcome: 02 Visits to GP/PN in 6 months

Study Action Plan Usual Care Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed)

N Mean(SD) N Mean(SD) 95% CI (%) 95% CI

Watson 1997 29 3.00 (3.00) 27 2.00 (3.00) 100.0 1.00 [ -0.57, 2.57 ]

Total (95% CI) 29 27 100.0 1.00 [ -0.57, 2.57 ]

Test for heterogeneity: not applicable


-4.0 -2.0 0 2.0 4.0


Analysis 01.03. Comparison 01 Action Plan versus usual care, Outcome 03 Number scheduled GP visits in 12

months



Outcome: 03 Number scheduled GP visits in 12 months

Study Mean Difference (SE) Mean Difference (Fixed) Weight Mean Difference (Fixed)

95% CI (%) 95% CI

McGlone 2004 -0.50 (1.82) 100.0 -0.50 [ -4.06, 3.06 ]

Total (95% CI) 100.0 -0.50 [ -4.06, 3.06 ]



-10.0 -5.0 0 5.0 10.0

Favours Action Plans Favours Usual Care

Analysis 01.04. Comparison 01 Action Plan versus usual care, Outcome 04 Number emergency visits to GP

for COPD in 12 months



Outcome: 04 Number emergency visits to GP for COPD in 12 months

Study Mean difference (SE) Mean difference (Fixed) Weight Mean difference (Fixed)

95% CI (%) 95% CI

McGlone 2004 -0.20 (0.69) 100.0 -0.20 [ -1.55, 1.15 ]

Total (95% CI) 100.0 -0.20 [ -1.55, 1.15 ]



-4.0 -2.0 0 2.0 4.0




Analysis 01.05. Comparison 01 Action Plan versus usual care, Outcome 05 Number of total GP visits in 12

months



Outcome: 05 Number of total GP visits in 12 months


95% CI (%) 95% CI

McGeoch 2004 0.07 (0.18) 100.0 0.07 [ -0.28, 0.43 ]

Total (95% CI) 100.0 0.07 [ -0.28, 0.43 ]



-1.0 -0.5 0 0.5 1.0


Analysis 01.06. Comparison 01 Action Plan versus usual care, Outcome 06 Number of times treated in the

emergency department in 12 months



Outcome: 06 Number of times treated in the emergency department in 12 months


95% CI (%) 95% CI

McGeoch 2004 -0.25 (0.27) 4.2 -0.25 [ -0.77, 0.28 ]

McGlone 2004 0.00 (0.06) 95.8 0.00 [ -0.11, 0.11 ]

Total (95% CI) 100.0 -0.01 [ -0.12, 0.10 ]



-1.0 -0.5 0 0.5 1.0


Analysis 01.07. Comparison 01 Action Plan versus usual care, Outcome 07 Days on Antibiotics in 6 months



Outcome: 07 Days on Antibiotics in 6 months



Watson 1997 29 10.00 (11.00) 27 4.00 (6.00) 100.0 6.00 [ 1.40, 10.60 ]

Total (95% CI) 29 27 100.0 6.00 [ 1.40, 10.60 ]



-10.0 -5.0 0 5.0 10.0

Favours Usual Care Favours Action Plan



Analysis 01.08. Comparison 01 Action Plan versus usual care, Outcome 08 Days on corticosteroids in 6

months



Outcome: 08 Days on corticosteroids in 6 months



Watson 1997 29 15.00 (22.00) 27 9.00 (22.00) 100.0 6.00 [ -5.53, 17.53 ]

Total (95% CI) 29 27 100.0 6.00 [ -5.53, 17.53 ]



-100.0 -50.0 0 50.0 100.0


Analysis 01.09. Comparison 01 Action Plan versus usual care, Outcome 09 Patients initiating antibiotics in 6

months



Outcome: 09 Patients initiating antibiotics in 6 months

Study Action Plan Usual Care Odds Ratio (Fixed) Weight Odds Ratio (Fixed)

n/N n/N 95% CI (%) 95% CI

Watson 1997 13/29 2/27 100.0 10.16 [ 2.02, 51.09 ]

Total (95% CI) 29 27 100.0 10.16 [ 2.02, 51.09 ]

Total events: 13 (Action Plan), 2 (Usual Care)



0.01 0.1 1 10 100




Analysis 01.10. Comparison 01 Action Plan versus usual care, Outcome 10 Patients initiating steroids in 6

months



Outcome: 10 Patients initiating steroids in 6 months

Study Action Plan Usual Care Odds Ratio (Fixed) Weight Odds Ratio (Fixed)

n/N n/N 95% CI (%) 95% CI

Watson 1997 10/29 2/27 100.0 6.58 [ 1.29, 33.62 ]

Total (95% CI) 29 27 100.0 6.58 [ 1.29, 33.62 ]




0.01 0.1 1 10 100


Analysis 01.11. Comparison 01 Action Plan versus usual care, Outcome 11 Courses of Antibiotics in 12

months



Outcome: 11 Courses of Antibiotics in 12 months


95% CI (%) 95% CI

McGeoch 2004 0.13 (0.18) 94.8 0.13 [ -0.22, 0.48 ]

McGlone 2004 0.40 (0.76) 5.2 0.40 [ -1.09, 1.89 ]

Total (95% CI) 100.0 0.14 [ -0.20, 0.48 ]



-1.0 -0.5 0 0.5 1.0




Analysis 01.12. Comparison 01 Action Plan versus usual care, Outcome 12 Courses of oral corticosteroids in

12 months



Outcome: 12 Courses of oral corticosteroids in 12 months


95% CI (%) 95% CI

McGeoch 2004 0.13 (0.37) 52.4 0.13 [ -0.59, 0.86 ]

McGlone 2004 0.60 (0.39) 47.6 0.60 [ -0.16, 1.36 ]

Total (95% CI) 100.0 0.35 [ -0.17, 0.88 ]



-1.0 -0.5 0 0.5 1.0


Analysis 01.13. Comparison 01 Action Plan versus usual care, Outcome 13 Number of subjects with >= 1

exacerbation COPD with antibiotics in 12 months



Outcome: 13 Number of subjects with >= 1 exacerbation COPD with antibiotics in 12 months

Study Action plan Usual care Peto Odds Ratio Weight Peto Odds Ratio

n/N n/N 95% CI (%) 95% CI

McGlone 2004 56/67 48/72 100.0 2.44 [ 1.14, 5.23 ]

Total (95% CI) 67 72 100.0 2.44 [ 1.14, 5.23 ]

Total events: 56 (Action plan), 48 (Usual care)



0.1 0.2 0.5 1 2 5 10

Favours usual care Favours action plan



Analysis 01.14. Comparison 01 Action Plan versus usual care, Outcome 14 Length of exacerbations



Outcome: 14 Length of exacerbations

Study Treatment Control Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed)

N

Mean(SD) N

Mean(SD) 95% CI (%) 95% CI

Total (95% CI) 0 0 0.0 Not estimable


Test for overall effect: not applicable

-10.0 -5.0 0 5.0 10.0

Favours treatment Favours control

Analysis 01.15. Comparison 01 Action Plan versus usual care, Outcome 15 SGRQ symptom scores at 6

months



Outcome: 15 SGRQ symptom scores at 6 months


95% CI (%) 95% CI

McGlone 2004 -6.40 (3.67) 70.0 -6.40 [ -13.60, 0.80 ]

Watson 1997 -1.00 (5.62) 30.0 -1.00 [ -12.01, 10.01 ]

Total (95% CI) 100.0 -4.78 [ -10.81, 1.24 ]



-100.0 -50.0 0 50.0 100.0




Analysis 01.16. Comparison 01 Action Plan versus usual care, Outcome 16 SGRQ activity scores at 6 months



Outcome: 16 SGRQ activity scores at 6 months


95% CI (%) 95% CI

McGlone 2004 -3.20 (2.72) 85.3 -3.20 [ -8.54, 2.14 ]

Watson 1997 2.00 (6.56) 14.7 2.00 [ -10.85, 14.85 ]

Total (95% CI) 100.0 -2.43 [ -7.37, 2.50 ]



-100.0 -50.0 0 50.0 100.0


Analysis 01.17. Comparison 01 Action Plan versus usual care, Outcome 17 SGRQ impact scores at 6 months



Outcome: 17 SGRQ impact scores at 6 months


95% CI (%) 95% CI

McGlone 2004 -0.50 (2.24) 76.2 -0.50 [ -4.89, 3.89 ]

Watson 1997 -1.00 (4.01) 23.8 -1.00 [ -8.86, 6.86 ]

Total (95% CI) 100.0 -0.62 [ -4.45, 3.21 ]



-10.0 -5.0 0 5.0 10.0




Analysis 01.18. Comparison 01 Action Plan versus usual care, Outcome 18 SGRQ total scores at 6 months



Outcome: 18 SGRQ total scores at 6 months


95% CI (%) 95% CI

McGlone 2004 -2.30 (1.98) 83.1 -2.30 [ -6.19, 1.59 ]

Watson 1997 0.00 (4.41) 16.9 0.00 [ -8.64, 8.64 ]

Total (95% CI) 100.0 -1.91 [ -5.46, 1.63 ]



-10.0 -5.0 0 5.0 10.0


Analysis 01.19. Comparison 01 Action Plan versus usual care, Outcome 19 SGRQ symptom scores at 12

months



Outcome: 19 SGRQ symptom scores at 12 months


95% CI (%) 95% CI

McGeoch 2004 2.30 (3.48) 56.7 2.30 [ -4.52, 9.12 ]

McGlone 2004 1.30 (3.98) 43.3 1.30 [ -6.51, 9.11 ]

Total (95% CI) 100.0 1.87 [ -3.27, 7.00 ]



-10.0 -5.0 0 5.0 10.0

Favours Action Plan FavoursUsual Care



Analysis 01.20. Comparison 01 Action Plan versus usual care, Outcome 20 SGRQ activity scores at 12 months



Outcome: 20 SGRQ activity scores at 12 months


95% CI (%) 95% CI

McGeoch 2004 -2.02 (2.92) 49.2 -2.02 [ -7.74, 3.70 ]

McGlone 2004 -3.60 (2.87) 50.8 -3.60 [ -9.23, 2.03 ]

Total (95% CI) 100.0 -2.82 [ -6.84, 1.19 ]



-10.0 -5.0 0 5.0 10.0


Analysis 01.21. Comparison 01 Action Plan versus usual care, Outcome 21 SGRQ impact scores at 12 months



Outcome: 21 SGRQ impact scores at 12 months


95% CI (%) 95% CI

McGeoch 2004 3.30 (2.33) 54.5 3.30 [ -1.27, 7.87 ]

McGlone 2004 -1.40 (2.55) 45.5 -1.40 [ -6.40, 3.60 ]

Total (95% CI) 100.0 1.16 [ -2.21, 4.53 ]



-10.0 -5.0 0 5.0 10.0




Analysis 01.22. Comparison 01 Action Plan versus usual care, Outcome 22 SGRQ total scores at 12 months



Outcome: 22 SGRQ total scores at 12 months


95% CI (%) 95% CI

McGeoch 2004 1.27 (2.26) 46.5 1.27 [ -3.16, 5.70 ]

McGlone 2004 -1.70 (2.11) 53.5 -1.70 [ -5.83, 2.43 ]

Total (95% CI) 100.0 -0.32 [ -3.34, 2.70 ]



-10.0 -5.0 0 5.0 10.0


Analysis 01.23. Comparison 01 Action Plan versus usual care, Outcome 23 FEV1 (mls) at 6 months



Outcome: 23 FEV1 (mls) at 6 months


95% CI (%) 95% CI

McGlone 2004 50.00 (40.74) 100.0 50.00 [ -29.86, 129.86 ]

Total (95% CI) 100.0 50.00 [ -29.86, 129.86 ]



-1000.0 -500.0 0 500.0 1000.0


Analysis 01.24. Comparison 01 Action Plan versus usual care, Outcome 24 FEV1 (mls) at 12 months



Outcome: 24 FEV1 (mls) at 12 months


95% CI (%) 95% CI

McGlone 2004 43.00 (54.23) 100.0 43.00 [ -63.30, 149.30 ]

Total (95% CI) 100.0 43.00 [ -63.30, 149.30 ]



-1000.0 -500.0 0 500.0 1000.0




Analysis 01.25. Comparison 01 Action Plan versus usual care, Outcome 25 FEV1 % predicted at 6 months



Outcome: 25 FEV1 % predicted at 6 months


95% CI (%) 95% CI

McGlone 2004 2.30 (1.59) 85.7 2.30 [ -0.81, 5.41 ]

Watson 1997 -1.00 (3.88) 14.3 -1.00 [ -8.61, 6.61 ]

Total (95% CI) 100.0 1.83 [ -1.05, 4.71 ]



-10.0 -5.0 0 5.0 10.0


Analysis 01.26. Comparison 01 Action Plan versus usual care, Outcome 26 FEV1 % predicted at 12 months



Outcome: 26 FEV1 % predicted at 12 months


95% CI (%) 95% CI

McGlone 2004 2.00 (1.98) 100.0 2.00 [ -1.89, 5.89 ]

Total (95% CI) 100.0 2.00 [ -1.89, 5.89 ]



-10.0 -5.0 0 5.0 10.0


Analysis 01.27. Comparison 01 Action Plan versus usual care, Outcome 27 FEV1/FVC at 6 months



Outcome: 27 FEV1/FVC at 6 months


95% CI (%) 95% CI

McGlone 2004 -0.50 (1.78) 100.0 -0.50 [ -3.99, 2.99 ]

Total (95% CI) 100.0 -0.50 [ -3.99, 2.99 ]



-10.0 -5.0 0 5.0 10.0




Analysis 01.28. Comparison 01 Action Plan versus usual care, Outcome 28 FEV1/FVC at 12 months



Outcome: 28 FEV1/FVC at 12 months


95% CI (%) 95% CI

McGlone 2004 -0.30 (2.14) 100.0 -0.30 [ -4.50, 3.90 ]

Total (95% CI) 100.0 -0.30 [ -4.50, 3.90 ]



-10.0 -5.0 0 5.0 10.0


Analysis 01.29. Comparison 01 Action Plan versus usual care, Outcome 29 Functional Capacity



Outcome: 29 Functional Capacity


N

Mean(SD) N

Mean(SD) 95% CI (%) 95% CI




-10.0 -5.0 0 5.0 10.0


Analysis 01.30. Comparison 01 Action Plan versus usual care, Outcome 30 Number of days symptoms

recorded in 6 months



Outcome: 30 Number of days symptoms recorded in 6 months



Watson 1997 29 144.00 (62.00) 27 160.00 (51.00) 100.0 -16.00 [ -45.65, 13.65 ]

Total (95% CI) 29 27 100.0 -16.00 [ -45.65, 13.65 ]



-100.0 -50.0 0 50.0 100.0




Analysis 01.31. Comparison 01 Action Plan versus usual care, Outcome 31 Days of breathing recorded as

usual in 6 months



Outcome: 31 Days of breathing recorded as usual in 6 months



Watson 1997 29 56.00 (37.00) 27 51.00 (37.00) 100.0 5.00 [ -14.39, 24.39 ]

Total (95% CI) 29 27 100.0 5.00 [ -14.39, 24.39 ]



-100.0 -50.0 0 50.0 100.0



mild in 6 months



Outcome: 32 Days of breathing recorded as mild in 6 months

Study Action Plans Usual Care Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed)


Watson 1997 29 18.00 (19.00) 27 21.00 (24.00) 100.0 -3.00 [ -14.39, 8.39 ]

Total (95% CI) 29 27 100.0 -3.00 [ -14.39, 8.39 ]



-100.0 -50.0 0 50.0 100.0



moderate in 6 months



Outcome: 33 Days of breathing recorded as moderate in 6 months

Study Action Plans Usual Care Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed)


Watson 1997 29 17.00 (24.00) 27 20.00 (26.00) 100.0 -3.00 [ -16.13, 10.13 ]

Total (95% CI) 29 27 100.0 -3.00 [ -16.13, 10.13 ]



-100.0 -50.0 0 50.0 100.0

Favours Action Plans Favours Usual Care




severe in 6 months



Outcome: 34 Days of breathing recorded as severe in 6 months



Watson 1997 29 8.00 (21.00) 27 8.00 (13.00) 100.0 0.00 [ -9.08, 9.08 ]

Total (95% CI) 29 27 100.0 0.00 [ -9.08, 9.08 ]


Test for overall effect z=0.00 p=1

-100.0 -50.0 0 50.0 100.0


Analysis 01.35. Comparison 01 Action Plan versus usual care, Outcome 35 Mortality



Outcome: 35 Mortality

Study Action Plan Usual Care Peto Odds Ratio Weight Peto Odds Ratio

n/N n/N 95% CI (%) 95% CI

McGeoch 2004 1/86 2/73 25.8 0.43 [ 0.04, 4.22 ]

McGlone 2004 5/67 4/72 74.2 1.37 [ 0.36, 5.26 ]

Total (95% CI) 153 145 100.0 1.01 [ 0.32, 3.24 ]



Test for overall effect z=0.02 p=1

0.01 0.1 1 10 100




Analysis 01.36. Comparison 01 Action Plan versus usual care, Outcome 36 Days lost from work



Outcome: 36 Days lost from work


N

Mean(SD) N

Mean(SD) 95% CI (%) 95% CI




-10.0 -5.0 0 5.0 10.0


Analysis 01.37. Comparison 01 Action Plan versus usual care, Outcome 37 HADS anxiety



Outcome: 37 HADS anxiety


95% CI (%) 95% CI

McGeoch 2004 0.14 (0.92) 100.0 0.14 [ -1.66, 1.94 ]

Total (95% CI) 100.0 0.14 [ -1.66, 1.94 ]



-4.0 -2.0 0 2.0 4.0


Analysis 01.38. Comparison 01 Action Plan versus usual care, Outcome 38 HADS depression



Outcome: 38 HADS depression


95% CI (%) 95% CI

McGeoch 2004 0.25 (0.43) 100.0 0.25 [ -0.59, 1.09 ]

Total (95% CI) 100.0 0.25 [ -0.59, 1.09 ]



-4.0 -2.0 0 2.0 4.0




Analysis 01.39. Comparison 01 Action Plan versus usual care, Outcome 39 SMI well knowledge



Outcome: 39 SMI well knowledge


95% CI (%) 95% CI

McGeoch 2004 1.10 (0.33) 100.0 1.10 [ 0.46, 1.74 ]

Total (95% CI) 100.0 1.10 [ 0.46, 1.74 ]



-4.0 -2.0 0 2.0 4.0

Favours Usual Favours Action Plan

Analysis 01.40. Comparison 01 Action Plan versus usual care, Outcome 40 SMI well actions



Outcome: 40 SMI well actions


95% CI (%) 95% CI

McGeoch 2004 0.50 (0.15) 100.0 0.50 [ 0.21, 0.79 ]

Total (95% CI) 100.0 0.50 [ 0.21, 0.79 ]



-1.0 -0.5 0 0.5 1.0

Favours Usual Care Favours Action Plans

Analysis 01.41. Comparison 01 Action Plan versus usual care, Outcome 41 SMI early exacerbation knowledge



Outcome: 41 SMI early exacerbation knowledge


95% CI (%) 95% CI

McGeoch 2004 1.80 (0.54) 100.0 1.80 [ 0.75, 2.85 ]

Total (95% CI) 100.0 1.80 [ 0.75, 2.85 ]



-4.0 -2.0 0 2.0 4.0




Analysis 01.42. Comparison 01 Action Plan versus usual care, Outcome 42 SMI early exacerbation actions



Outcome: 42 SMI early exacerbation actions


95% CI (%) 95% CI

McGeoch 2004 2.30 (0.68) 100.0 2.30 [ 0.96, 3.64 ]

Total (95% CI) 100.0 2.30 [ 0.96, 3.64 ]



-4.0 -2.0 0 2.0 4.0


Analysis 01.43. Comparison 01 Action Plan versus usual care, Outcome 43 SMI severe exacerbation

knowledge



Outcome: 43 SMI severe exacerbation knowledge


95% CI (%) 95% CI

McGeoch 2004 2.50 (0.74) 100.0 2.50 [ 1.04, 3.96 ]

Total (95% CI) 100.0 2.50 [ 1.04, 3.96 ]



-4.0 -2.0 0 2.0 4.0


Analysis 01.44. Comparison 01 Action Plan versus usual care, Outcome 44 SMI severe exacerbation actions



Outcome: 44 SMI severe exacerbation actions


95% CI (%) 95% CI

McGeoch 2004 1.50 (0.45) 100.0 1.50 [ 0.62, 2.38 ]

Total (95% CI) 100.0 1.50 [ 0.62, 2.38 ]



-4.0 -2.0 0 2.0 4.0




Action Plan for Chronic Obstructive Pulmonary Desease

Documents

usual care

action plans

sgrq symptom scores

sgrq total scores

number of total gp visits

number emergency visits

sgrq activity scores

sgrq impact scores