In this document,we summarise the unmet research needs to improve the services provided within primary care for patients with COPD.These are grouped into three key themes:case identification; therapeutic interventions and delivery of care for COPD.

A Case Identification:defining COPD

What is COPD? There are a number of definitions used in secondary care and guidelines,all of them dependent on spirometry.Primary care does not always have access to spirometry,which precludes the diagnosis of COPD using these criteria in many primary care practices.Even in practices where spirometry is available many GPs will diagnose a patient as having COPD on other issues such as symptoms and history.Most primary care physicians diagnose COPD clinically including chronic bronchitis and emphysema.A possibility would be that GPs consider COPD as a part of smoking related lung disease,as defined in several Scandinavian countries.Although there are a number of arguments that support this vision we have decided to adopt the Global Initiative on Obstructive Lung Disease (GOLD)3 committee guidelines for our definition of COPD.

Definition of COPD (www.goldcopd.com)

"COPD is a disease state characterized by airflow limitation that is not fully reversible.The airflow limitation is usually both progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases."

Therefore,in order to accurately diagnose and stage COPD in accord with these guidelines,a spirometer or access to spirometry should be readily available to every primary care physician.

The GOLD guidelines 3 consider the stage of disease definition of group 0,i.e.patients with chronic symptoms but without impairment of lung function (Table 1).These patients are of special interest for primary care.They often have severe symptoms and there is no evidence about how to treat these patients.While GOLD guidelines recommend smoking cessation as the sole intervention,patients themselves may consider this as insufficient treatment and that they need
more attention.

Table 1: The GOLD committee define four groups of severity³

Unresolved issues

Group 0 patients in GOLD guidelines 3

• Are there any co-morbidities which encourage people to continue smoking e.g.anxiety/depression?
  
• What are the patient needs in this group?
  
• Which interventions in this group of patients will really help?
  
• Why is it necessary to identify these patients?
  
• What is the cost and benefit of identifying these patients?
  
  COPD in general
  
  
• What is the influence of quality of life and symptoms in the perception of
  COPD and time of diagnosis?
  
• What are the influences of cultural differences in diagnosing COPD?
  
  B.Therapeutic interventions in COPD:the following key themes were regarded important in primary care:

i How to manage patients with apparent COPD currently treated with inhaled
corticosteroids (ICS)?
ii Research questions related to ICS and COPD
iii Education and self management plans or "Action plans"
iv What do patients with COPD want and how can these needs be identified?
v Smoking cessation.
vi Exacerbations
vii Guideline based management
viii Data recording

i How to manage patients with apparent COPD currently treated with inhaled corticosteroids (ICS)?

GOLD guidelines recommend the use of inhaled steroids in patients with COPD only when the effect of ICS has been proven over a period of 6 weeks or the patient is at risk of severe exacerbations.Since many patients currently receive ICS without a formal diagnosis or having had an ICS reversibility test, physicians may feel pressurized by guidelines to stop ICS in these patients.We believe that this could lead to serious problems for some of these patients.Anecdotally, we recall a number of cases experiencing sudden exacerbations and one case of fatal exacerbation. The Isolde and Euroscop trials demonstrated an improvement on IGCS,however,these trials were done using high doses of inhaled steroids and the improvement was only sustained for a period of three months.^4,5 We identified the following questions regarded inhaled steroids.

ii Research questions related to ICS and COPD:

• How long should a trial of Inhaled Glucocorticosteroids last?
  
• What dose should it be carried out?
  
• Is there any difference in outcomes between
  conventional CFC steroids and newer HFA steroids
  with greater small airways deposition?
  
• Is it possible to stop ICS in patients with apparent
  COPD and what are the effects on long and
  short-term outcomes?
  
• Which disease markers predict successful ICS
  treatment and cessation if already commenced?
  Do patients with non-smoking related COPD
  respond differently to ICS.

iii Education and self management plans or "Action plans"

Education and self-management plans are not always very successful,many primary care physicians and nurses regard these as complex.We believe self-management plans should be renamed as action plans. The clear consensus from research in other diseases including asthma is that these action plans need to be personalised to be effective.^3,4

Research questions:

• What is the influence of a personalised holistic
  action plan for patients with COPD on exacer-
  bations,quality of life,symptoms and costs?
  
• What is the patient attitude towards self-
  management or action plans?

iv What do patients with COPD want and how can
these needs be identified?

Much research has focused on therapeutic interventions although little account has been taken of the patient's agenda that may vary substantially from patient to patient. Understanding this agenda is fundamental to delivery of patient-centred care in primary care and understanding important outcome measures from the point of view of the patient.

Research needs:

• What are patients'beliefs about COPD/respiratory
  disease and smoking and how does this affect their
  attitudes to any form of intervention?
  
• What are the patients'needs with regard to
  symptom relief?
  
• Which symptoms should we focus on with
  therapeutic interventions in clinical practice and
  research?
  
• Are health care professionals informed enough
  about the needs of patients with COPD?
  
• What do patients consider the most important
  improvement that they could have as related to
  their disease?
  
• What is the impact of depression,neuroticism,
  anxiety,and cognitive failure on their perception
  and coping with COPD?
  
• Does it improve outcomes if we consider quality of
  life and depression as influential topics within our
  treatment plans?
  
• What are the relations of various patient-focused
  outcome measures?
  
• What are the goals of patients for treatment of their
  COPD?
  
• Can these goals be used for evaluation of treatment
  response and how should this be done?

v Smoking cessation

A number of significant barriers exist regarding general practitioners undertaking smoking cessation.We need to research effective ways of undertaking smoking cessation within "real-life"clinical practice.

Research that may help:

• Is it possible to develop an effective short "30
  second" method of smoking cessation appropriate for use in primary care consultations?
  
• Why are guidelines for smoking cessation not
  followed?
  
• What do patients want when they visit a primary
  care physician in relation to smoking behaviour?
  
• What is the effect of case finding in a general
  practice and does it have any influence on smoking
  behaviour?
  
• Furthermore does case finding followed by proper
  disease management have any influence on
  morbidity and mortality due to COPD?

vi Exacerbations

After decades of research and debate we have not reached a proper consensus on defining and treating an exacerbation of COPD.Exacerbations are generally considered to be an increase of breathlessness with increased quantity and purulence of sputum.

We therefore propose the following research
questions:

• What is an appropriate and useful definition of an
  exacerbation of COPD in primary care?
  
• When should we use antibiotics and /or steroids
  during an exacerbation of COPD?
  
• And how can this be incorporated into patient
  management/action plans?

vii Guideline based management

With the advent of international guidelines for the management of COPD it is fundamental that we examine a number of questions related to guideline implementation and effectiveness in primary care:

• What is the impact of guideline management on
  outcomes for patients with asthma?
  
• Can adherence to effective guidelines be
  improved in primary care?

viii Data recording

Currently no clear consensus exists on what is the most important data to collect in COPD management and it is therefore if we wish to audit care in primary care that we define an evidence based minimum dataset for the management of COPD.

C. Delivery of Care

Debate currently focuses on who should deliver care in COPD and to whom.Potential different models are shown in figure 1 with varying levels of specialism in primary and secondary care as well as the use of shared care between generalists and specialists as well.

Research needs:

• What are the necessary components of successful
  quality care in primary care?
  
• What equipment is required?
  
• What components of care can and should be
  delivered in every general practice?
  
• Can specialist care be effectively and cost-
  effectively delivered in primary care?
  
• Who should be referred to specialist care either
  in primary or secondary care?
  
• What equipment is necessary for differing levels
  of care in primary care?
  
• How is quality control maintained in primary care?
  
• What is the impact of differing health care
  systems in terms of health care costs and patient
  outcomes?
  
• What are the costs of differing models?
  
• Should the generalist GP deliver routine care for
  patient with COPD or is it a disease for
  secondary care?
  
• What system of monitoring and structured recall is
  appropriate for differing severities of COPD?
  
• Can pulmonary rehabilitation be delivered in primary care and is it effective in this setting?

Figure 1:Models of delivery of COPD Care

Conclusions and project development

The Aberdeen meeting has identified key essential research needs for ensuring effective care for patients with COPD in primary care.We have developed four strategic groups to develop detailed research agendas for the areas outlined above including literature reviews to lay the ground work for future research work to answer this research needs statement. This groundwork will be completed and published during the autumn. A follow-up conference is planned for March of 2002 to evaluate progress on designing research proposals and to feedback on some pilot research projects that are being undertaken.

REFERENCES

1. Charlton I,Charlton G,Broomfield J,Mullee MA.Evaluation of peak flow and symptoms only self management plans for control of asthma in general practice. BMJ 1990;301 :1355-59.
   
2. Lahdensuo A.Guided self-management of asthma. How to do it. BMJ 1999;319 :759-60.
   
3. Pauwels R et al .Global Strategy for the Diagnosis,Management, and Prevention of COPD.World Health Organisation.2001.
   
4. Pauwels RA,Lofdahl CG,Laitinen LA,Schouten JP,Postma DS, Pride NB,et al .Long-term treatment with inhaled budesonide in persons with mild chronic obstructive pulmonary disease who continue smoking. N Engl J Med 1999;340 :1948-53.
   
5. Burge PS,Calverley PM,Jones PW,Spencer S,Anderson JA,
   Maslen TK.Randomised,double blind,placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: the ISOLDE trial. BMJ 2000;320 :1297-303.

ACKNOWLEDGMENTS
We would like to thank:

Boehringer Ingelheim who supported this meeting with an independent educational grant to the University of Aberdeen.

The staff of the Department of General Practice and Primary Care at the University of Aberdeen for hosting and organising the meeting particularly Debbie Bone,Carol Morgan and Ann Christie.

Prim Care Respir J 2001:10(2);47-50