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14 aspirin - analysis of gastrointestinal bleeding during the UK-TIA trial. Gut 1995; 37: 509-11 7. Weil J, Colin-Jones D, Langman MJS, et al. Prophylactic aspirin and risk of peptic ulcer bleeding. Br Med J 1995; 310: 827-30 8. Kaufman DW, Kelly JP, Sheehan JE, et al. Nonsteroidal anti-inflammatory drug use in relation to major upper gastrointestinal bleeding. Clin Pharmacol Ther 1993; 53: 485-94 9. Lee M, Cruer B, Feldman M. Dose effects of aspirin and gastric prostaglandins and stomach mucosal injury. Ann Intern Med 1994; 120: 184-9

10. Lanza F, Peace K, Gustitus L, et al. A blinded endoscopic comparative study of misoprostol versus sucralfate and placebo in the prevention of aspirin-induced gastric and duodenal ulceration. Am J Gastroenterol 1988; 83: 143-6 II. Goddard AF, Donnelly MT, Filipowicz B, et al. Low-dose misoprostol as prophylaxis against low-dose aspirin-induced gastroduodenal mucosal injury [abstract]. Gut 1996; 39 Suppl. I: A33 12. British National Formulary No. 33. London: The Pharmaceutical Press, 1997 Mar: 39

Quality-of-life measurements not yet proven useful in primary care of chronic obstructive pulmonary disease Quality of life (QOL) is important both to patients with chronic obstructive pulmonary disease (COPD) and their physicians. However, although QOL instruments have proved to be of value for research purposes, the value of these instruments within the primary-care setting has still to be established.

Measuring QOL Instruments used to measure QOL can be categorised as I of 2 types, those that assess overall QOL and those that assess aspects directly related to a particular disease. These 2 types are known as generic and disease-specific instruments, respectively.ll ,2]

For tile patient witll COPD, perceived l,eaitlT status is quite probably tile most important aspect of Il ealthca l'e There are limited data available from studies using disease-specific QOL instruments in patients with COPD.l2] Moreover, the value of generic instruments to monitor the course of COPD is questionable. r1J

Generic versus specific QOL instruments Although generic questionnaires enable comparisons between different diseases, they only give a general impression of health, and therefore are less able to establish the specific restrictions related to a certain disease or to detect a possible improvement after treatment. Disease-specific QOL instruments are much morc sensitive in establishing a decreased QOL for a specific disease. Examples of generic and COPD-specific QOL instruments are shown in table I.

Vol. 10, No.4; August 18,1997

QOL not always related to COPO severity It is now well known that a patient's perceived health status does not necessarily correspond to objective health as established by clinical parameters.f IJ Furthermore, subjective complaints experienced by the patient do not always correspond to a decrease in QOL measurements. Often, objective parameters indicate that a patient is seriously ill and requires treatment, without the patient perceiving this as a decline in health. In this situation, the patient will be less motivated to undergo treatment.[I] In COPD, some patients with serious airway obstruction have a QOL measurement that is not diminished. The fact that a patient has to stop for breath while halfway up the stairs does not necessarily mean that this is attributed by the patient to COPD; the patient may attribute this to advanced age or reduced physical condition, which might not be apparent in generic QOL questionnaires.

No correlation shown in generic questionnaires In a 4-year study of 28 patients receiving therapy for COPD[3J, no relationship was found between the change in QOL and change in lung function. QOL was assessed using the generic QOL instruments Inventory of Subjective Health (ISH) and Nottingham Health Profile (NHP). Objective parameters of the severity of COPD (lung function, bronchial hyper-responsiveness, peak flow and symptom score) were also assessed. The patients had an annual decline in forced expiratory volume in 1 second (FEV I) of ~80 ml/year combined with at least 2 exacerbations per year when treated only with bronchodilatory medication. In the first 2 years of the study, the patients only received bronchodilatory therapy, but during the second 2 years they also received an inhaled corticosteroid.l 4 ] Although corticosteroids caused a statistically significant increase in lung function during the first 6 months after

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/5

Some examples of quality-ot-life instruments that may be used in chronic obstructive pulmonary disease ent[2] Dimensions and domains examined

No. of items (time to conduct)

Method of administration

Chronic Respiratory Disease QuestionnaIre (CRDO)

Dyspnoea, emotional dysfuncllon , fatigue, mastery over disease

20 (20 min)

Trained interviewer

SI. George's Respiratory Questionnaire (SGRO)

Activity: physical functioning, housework, hobbies

76 (?)

Sell·administered

Symptoms: cough, sputum, breathlessness, wheeze

Oxygen Cost Diagram (OCD)

Single vertica l line marked in location to indicate degree of disability caused by dyspnoea

1 «5 min)

Sell-administered

Baseline Dyspnoea Index (BOI)

Functional Impairment , magnitude of effort evoking dyspnoea, magnitude of task evoking dyspnoea

3 «5 min)

Trained Interviewer

Sickness Impact Profile (SI P)

Social: general well·being, work/social role performance, global social funotion , social support and participation, global emotional functioning , personal re lationships

136 (30 min)

Sel f-administered

Medical Outcomes Study (MOS)

Functioning: physical, role , social

20 (3 min)

Self·administered

Quality of Wel f-Being

Mobility: access to transportation

50 (12 min)

Trained interviewer

45 (10 min)

Self-administered

COPO-speciflc instruments

Impact on daily life: social and emotional impact

Generic Instruments

Physical : ambulalion , mobility, body care

(aWS)

Well·being: health perceptions, mental health, bodily pain Physical: limits to activity Social : limits to activity Symptoms: review ot symptoms

Nottingham Health Profile (NHP)

Health: pain , energy, sle ep, emotional reactions, physical mobility, social isolation Life functioning : relationships , employment, personal life, hobbies, sex, vacations, housework

Symbol: ? = information not available.

they were initiated, there was no improvement in the ISH score or the scores for the 6 dimensions of the NHP.

... but specific questionnaires show OOL benefits In contrast, recent studies using disease-specific questionnaires have shown a positive effect of rehabilitation l5 ,6J and mucolytic treatment l7J on QOL in patients with severe impairment due to COPD.

Generic instruments useful in severe COPO? It has been postulated that the degree of correlation between lung function and QOL depends on the severity of obstruction. 181 When patients with COPD have very severe obstruction, QOL may be better related to the level of, or the changes in, lung function. In that case, measuring generic QOL would be of less importance in the primary-care setting, where mild to moderate cases of COPD are generally treated. Conversely, the measurement

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of QOL life via generic instruments would be more useful in patients with severe COPD. Another explanation for the lack of correlation between generic QOL and lung function is that in COPD the level of hypoxaemia is a potentially influential factor that might be, to some extent, independent of the degree of airways obstruction as measured by FEV 1J9]

OOL assessment: no proven benefit in COPO QOL is important to both the patient and the physician; for the patient, perceived health status is quite probably the most important aspect of healthcare.l 11 For the time being, however, it is difficult to include this aspect in the primary care of patients with COPD in a proper and well-balanced way, because it is not known what value to attach to a change in QOL scores and what consequence this has for medical care. Moreover, it might be possible that only patients with severe COPD have a detectably impaired QOL as assessed by generic instruments, which obviously makes

),,,1. 10, No.4; Augu.,t 18, 1997

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16 these instruments less suitable for use in the primarycare setting. Before QOL assessment is included in the medical care of patients with COPD, it will first have to be established if it really improves patient health, both in objective and subjective terms.[1]

I. van Schayck CPo Measurement of quality of life in patients with chronic obstructive pulmonary disease. PharmacoEconomics 1997 Jan; II (I): 13-8 2. Curtis JR, Deyo RA, Hudson LD. Health-related quality of life among patients with chronic obstructive pulmonary disease. Thorax 1994; 49: 162-70 3. van Schayck CP, Dompeling E, Rutten MPH, et al. The influence of an inhaled steroid on quality of life in patients with asthma or COPD. Chest 1995; 107: 1199-1205

crTllL'ltlJ.nj Perspectives

5. Goldstein R, Gort EH, Stubbling D, et al. Randomized controlled trial of respiratory rehabilitation. Lancet 1994; 344: 1394-7 6. Wijkstra PJ, van Altena R, Kraan J, et al. Quality of life in patients with chronic obstructive pulmonary disease improves after rehabilitation at home. Eur Respir J 1994; 7: 269-73

References

~prugs

4. Dompeling E, van Schayck CP, van Grunsven PM, et al. Slowing the deterioration of asthma and chronic obstructive pulmonary disease observed during bronchodilator treatment by adding inhaled corticosteroids: a 4-year prospective study. Ann Intern Med 1993; 118: 770-8

7. Petty TL. The national mucolytic study. Results of a randomized, double-blind placebo-controlled study of iodinated glycerol in chronic obstructive bronchitis. Chest 1990; 97: 75-83 8. Ketelaars CAJ, Schlosser MAG, Mostert R, et al. Determinants of health-related quality of life in patients with chronic obstructive pulmonary disease. Thorax 1996; 51: 39-41 9. Okubadejo AA, Jones PW, Wedzicha JA. Quality of life in patients with chronic obstructive pulmonary disease and severe hypoxaemia. Thorax 1996; 51: 44-7

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