Pandora Pound, Michael Bury, Patrick Gompertz, Shah Ebrahim ... views 10 months after the stroke. .... sampling during the last two months of the sampling.
Key messages * The aetiology of chronic fatigue syndrome is poorly understood * It is viewed by some as a variety of somatisation or abnormal illness behaviour * The illness behaviour profile in the chronic fatigue syndrome is the same as that in multiple sclerosis * Scores on the illness behaviour questionnaire cannot be taken as evidence that the chronic fatigue syndrome is a variety of somatisation * We need to know more about the origins of illness beliefs in the chronic fatigue syndrome, especially as they are important in determining outcome.
3 McEvedy CP, Beard AW. Concept of benign myalgic encephalomyelitis. BMY 1970;i:1 1-5. 4 Kleinman A, Kleinman J. Somatisation: the interconnections in Chinese society among culture, depressive experiences, and meaning of pain. In: Kleinman A, Good B, eds. Culture and depression. Studies in the anthropology and cross culture psychiatry of affect and disorder. Berkeley: University of California Press, 1985:429-90. 5 American Psychiatric Association. Diagnostic and statistical manual of mental disorders, third editwn, revised. Washington, DC: APA, 1987. 6 Manu P, Matthews DA, Lane TJ. The mental health of patients with a chief complaint of chronic fatigue: prospective evaluation and follow-up. Arch Intern Med 1988;148:2213-7. 7 Wessely S, Powell R. Fatigue syndromes: a comparison of chronic postviral fatigue with neuromuscular and affective disorder. J Neurol Neurosurg Psychiatry 1989;52:940-8. 8 Smith GR, Monson RA, Ray DC. Patients with multiple unexplained symptoms: their characteristics, functional health, and health care utilisation. Arch Intern Med 1986;146:69-72. 9 Pilowsky I. Abnormal illness behaviour. BrJMedPsychol 1969;42:347-51. 10 Mechanic D. The concept of illness behavior. Journal of Chronic Diseases
1961;5:189-94.
how patients represent illness to themselves and others we need to know not just what beliefs and behaviours the patients have but how they have acquired them and what evidence they use to support them. To our knowledge, a standardised measure for these aspects of the so called illness representation 25 does not exist; it needs to be developed. Secondly, we have confirmed that disease conviction is common in chronic fatigue syndrome. We need to understand not just why that is but whether disease conviction has the relation to outcome reported elsewhere and how such a relation is mediated if it is confirmed. This study formed part of an MMedSc dissertation by PT. We thank Amanda Trigwell for help in computerising and handling the data, Dr Stephen Morley for statistical advice, and Dr Helen Ford for advice and information regarding the multiple sclerosis group. Source of funding: No additional funding. Conflicts of interest: None. 1 Wessely S, Thomas PK. The chronic fatigue syndrome-myalgic encephalomyelitis or postviral fadgue? In: Kennard C, ed. Recent advances in neurology. Vol 6. Edinburgh: Churchil livingptone, 1990. 2 David AS, Wessely S, Pelosi AJ. Poseviral fatigue syndrome: time for a new approach. BMJ 1988;296:696-8.
11 Parsons T. The social system. New York: Free Press of Glencoe, 1952. 12 Pilowsky I, Spence ND. Manual for the illness behaviour questionnaire (IBQ). 2nd ed. Adelaide: University of Adelaide, 1983. 13 Hickie I, Lloyd A, Wakefield D, Parker G. The psychiatric status of patients with the chronic fatigue syndrome. BrJPsychiatry 1990;156:534-40. 14 Schweitzer R, Robertson DL, Kelly B, Whiting J. Illness behaviour of patients with chronic fatigue syndrome.JPsychosom Res 1994;38:41-9. 15 Wilson A, Hickie I, Lloyd A, Hadzi-Pavlovic D, Boughton C, Dwyer J, et al. Longitudinal study of outcome of chronic fatigue syndrome. BM3 1994;308:756-9. 16 Freal JE, Kraft GH, Coryell JK. Symptomatic fatigue in multiple sclerosis. Arch Phys Med Rehabil 1984;65:135-8. 17 Krupp LB, Alvarez LA, LaRocca NG, Scheinberg LC. Fatigue in multiple sclerosis. Arch Neurol 1988;45:435-7. 18 Pemberton S, House AO, Stanley PJ, Hatcher S. Chronic fatigue syndromea way forward. BritishJournal of Occupational Therapy (in press). 19 Sharpe MC, Archard LC, Banatvala JE, Borysiewicz LK, Clare AW, David A, et al. A report-chronic fatigue syndrome: guidelines for research. Y R Soc Med 1991;84:118-21. 20 Poser CM, Paty DW, Scheinberg L, McDonald WI, Davis FA, Ebers GC, et al. New diagnostic criteria for multiple sclerosis: guidelines for research protocols. Ann Neurol 1983;13:227-31. 21 Confavreux C, Aimard G, Devic M. Course and prognosis of multiple sclerosis assessed by the computerised data processing of 349 patients. Brain 1980;103:281-300. 22 Poser S, Wilkstrom J, Bauer HJ. Clinical data and the identification of special forms of multiple sclerosis in 1271 cases studied with a standardised documentation system. Neurol Sci 1979;40:159-68. 23 Matthews WB. Course and prognosis. In: Matthews WB, ed. McAlpine's multiple sclerosis. 2nd ed. London: Churchill Livingstone, 1991:139-64. 24 Zonderman AB, Heft MW, Costa PT. Does the illness behavior questionnaire measure abnormnal illness behavior? Heakh Psychol 1985;4:425-36. 25 Murray M. Lay representations of illness. In: Bennett P, Weinman J, Spurgeon P, eds. Current developments in health psychology. London: Harwood Academic, 1991:63-90.
(Accepted 13April 1995)
Stroke patients' views on their admission to hospital Pandora Pound, Michael Bury, Patrick Gompertz, Shah Ebrahim
Department of Public Health, Royal Free Hospital School of Medicine, London NW3 2PF Pandora Pound, research
sociologist Patrick Gompertz, research fellow Shah Ebrahim, professor of dinical epidemiology Department ofSocial Policy and Social Science, Royal Holloway College, University of London, Egham Hill, Surrey W20 OEX Michael Bury, professor of sociology
Correspondence to: Ms Pound. BMe 1995;311:18-22
18
Abstract Objective-To explore which components of care were valued by patients admitted to hospital following a stroke. Design-Qualitative study using in depth interviews 10 months after the stroke. Setting-Two adjacent districts in North Thames Regional Health Authority. Subjects-82 survivors of stroke taken consecutively from a stroke register, 40 of whom agreed to be interviewed. Results-Patients reported that during the acute stage of the stroke they wanted to put their faith in experienced and trusted experts who would help them make sense of the event, take all the actions necessary to ensure survival, and provide comfort and human warmth during the crisis. In addition to being reassured by the clinical tests and practical nursing help they received, patients valued feeling cared about by the staff. In most cases patients reported that their needs were met; however, the institutional nature of the hospital sometimes obstructed the fiulflment oftheir needs. Conclusion-Patients have important psychosocial needs during the acute stage of the stroke,
which are often met by hospital admission. Patients gained benefits from their admission over and above those measurable in terms of morbidity or function. They used a combination of criteria to evaluate their care, focusing on the process as well as the outcome of care. Researchers and clinicians should do likewise.
Introduction Whether people should be admitted to hospital or cared for at home in the immediate aftermath of stroke has been debated for almost two decades.14 At first the prevailing belief was that unless it was absolutely necessary, people should be admitted to hospital on medical grounds only, while domiciliary care should be improved so that more patients could remain at home. The arguments in favour of hospital admission focused firmly on the potential clinical benefits, with mortality and levels of disability being the outcomes of interest. Isascs was alone in considering the possibility that less tangible benefits might be gained from hospital admission.7 While it is increasingly recognised that patients have psychosocial needs in the aftermath of stroke, it has recently been argued that these needs may be BMJ VOLUME 311
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neglected in hospital.8 Throughout the course of this debate, however, there has been little interest in researching the views of people who have actually experienced treatment for stroke. An early, qualitative study of stroke patients in a Canadian teaching hospital found that health professionals felt uneasy when dealing with stroke patients because they believed that nothing could be done for them in the acute care setting.9 Hoffman explored the impact of this unease on professionals' interactions with stroke patients and found that communication was often hindered as a result. Indeed, one of the few later studies which explored the attitudes of stroke patients towards hospital admission found that, although patients seemed to respect the technical skills of health professionals, they complained of poor communication, insensitivity, and a lack of empathy.10 More recently, however, a relatively high level of satisfaction with inpatient care has been found, including communication and the personal social skills of staff," while a longitudinal survey of patients' and carers' experiences after stroke reported mixed views.12 As part of the latter survey, patients were asked if there was anything about their hospital stay that especially pleased or upset them. About two thirds of the sample reported something positive, most commonly the kindness of the nurses. Under half identified something upsetting, and this again related to nurses, the most common complaint being difficulty in obtaining help with getting to the toilet. The experience of chronically ill patients within an acute care setting is a relevant area of inquiry, yet it remains relatively neglected."3 This paper reports the findings from a qualitative study of people's experiences in hospital immediately after a stroke. The study attempted to find out which components of care were valued by patients during their acute admission. We considered that a methodology which allowed a free flowing account of patients' experiences, rather than simply their opinions, would yield insights unattainable through the more structured approaches mentioned above." 12 Qualitative methods are increasingly recognised as an important element in health services research, especially in clarifying the dimensions of care that matter to patients and providing a conceptual framework for analysing them.'4
between those who accepted and those who refused the invitation to participate in the in depth interviews were explored using Student's t test, the Mann-Whitney U test, and X2 where appropriate. For the interviews, people were asked to provide accounts of their experiences, beginning with what happened on the day of the stroke and continuing through to their admission to hospital and their experiences there. Each interview covered the same general areas, but within subject areas the conversation was flexible. Carers were sometimes present during interviews, and their accounts were also included here; since some people had speech impairments, their contributions were helpful and important. The interviews were conducted an average of 10 months after the stroke. All (except one) were conducted in people's homes and tape recorded. The transcripts of the recordings were then content analysed, which involves reading through the data, identifying recurrent themes, coding them, and organising them into categories. These categories were then systematically compared across the transcripts to refine the classifications or create new typologies.'4 Results SAMPLE
Of the 82 people approached, 40 accepted our invitation to participate in the interviews, giving a take up rate of 49%/o. The sample consisted of 21 men and 19 women. Thirty five were white, three were Bangladeshi, and two were black Caribbean. The mean age at the time ofinterview was 71 (range 40-87) years. Twenty three people lived in council housing and five in warden supervised accommodation; eight were owner occupiers, two were living in privately rented houses, one person was in bed and breakfast accommodation, and another was staying in her daughter's home at the time of the interview. Thirty nine people identified a main carer, of whom 19 were spouses. Sixteen people lived alone. Six months after the stroke there were no significant differences between those who accepted the invitation to be interviewed and those who refused, either in terms of disability (using the Barthel and the extended activities of daily living scale) or according to age at time of stroke, age they left full time education, last employment (manual or non-manual), whether they lived alone, housing tenure, sex, or race.20 However, those who accepted were slightly less disabled 12 months after the stroke than those who refused, as the table shows.
Methods During a period of nine months, survivors' names were taken consecutively from the North East Thames Stroke Outcome Study stroke register when they reached the 10th month after their stroke, and people were invited to take part in an interview. The register COMPONENTS OF CARE contains data on all acute stroke admissions to the four In general, 26 people were positive about their stay major hospitals in two adjacent health districts in in hospital, five were negative, and an additional six North Thames Regional Health Authority between were both positive and negative. (Three people were January 1991 and March 1992 and has been described more concerned to discuss their housing problems and in more detail elsewhere."5 Those lost to follow up in their interviews were not used.) Four components of the study, those who had moved out of the study area, care were identified; being cared about (14 people), those who were still inpatients at 10 months, and those clinical care (13), nursing care (10), and information or known to be unable to participate owing to dementia advice (4). Seven people referred to aspects of care in (n=3) or severe speech impairment (n=3) were two categories and two to aspects in three categories. excluded from the sampling frame. Additionally, because fewer women than men were able to partici- Being cared about pate, owing to ill health, men were excluded from The feeling of being personally valued and cared sampling during the last two months of the sampling about by the staff in the hospital was of great importperiod. ance to respondents. Such feelings arose from nurses or For the North East Thames Stroke Outcome Study, doctors displaying kindness, warmth, individual attenpatients were followed up at six and 12 months with a tion, encouragement, and other apparently genuine range of outcome measures, including the Barthel indications that the person had been recognised as an index,'6 the Nottingham extended activities of daily important individual and not "just another patient." living scale,'7 the Nottingham health profile,"' the short Recovery, then, was atttibuted not only to the clinical form of the geriatric depression score,"9 and a patient skills of health professionals but to the experience of satisfaction questionnaire." Differences in outcome being looked after and attended to at the level of the
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19
Test scores of stroke patients who accepted invitation to intenoiew and those who did not. Scores are means unless otherwise indicated. (Reproducedfirom Pound etaP°)
6 Months after stroke: Barthel index (median) Nottingham extended activities of dailyliving(median) Nottingham health profile: Energy Pain Emotion Sleep Social isolation Physical mobility Geriatric depression 12 Months after stroke: Barthel index (median) Nottingham extended activities of daily living (median) Nottingham health profile: Energy Pain Emotion Sleep Social isolation Physical mobility Geriatric depression
*n=39. tn=29.
Interview
No interview
P value
n=40 17
n=41 16
0-19
8* 56 20 27 30 21 40 7 n=38 16-5 9 56 21 28 31 27 48 7
7
0-13
58 28 24 35 23 45 6* n=28 13t
0 50 0-19 0 97 0-67 0-22 0-19
3.5t 60 35 29 36 28 54
8*
0-92
0 039 0-014 0-71 0-06 0-83 0-51 0-89 0-47 0-45
#n=25.
person as well as the affected body. People were asked if they thought going into hospital after their stroke had been important and if so, why. The following are typical replies: 'Well, I mean people say what they think. I think they made me feel as though I was wanted and I could be looked after. To be-to know that you've got somebody that's caring. You know? Oh I think that goes a long way." "Oh the attention they gave me, definitely, and the nurses. Oh
definitely." "I think the attention you get from the nurses really." These interviews suggested that the sense of being respected and valued contributed towards a favourable outcome after their stroke. If this sort of "emotional work" was not in evidence, and particularly if
people felt their humanity had been denied, great distress could ensue. One woman felt that the nurses had been so rude to her that, when it later became necessary to be readmitted, she refused despite her family doctor's best efforts to persuade her. Similarly, a husband reported that nurses had been so slow in responding to his wife's calls to go to the toilet that she had to lie in her faeces until the nurses arrived, upon which she was chastised for having soiled the bed. He complained to the consultant, but the flippancy with which he felt the complaint was received only increased the couple's sense of humiliation and injustice. Another example of lack of care was in the case of doctors' insensitivity in conveying the diagnosis. "I had one doctor come over to me and he said, 'Ah, you've had a stroke.' And he went away. The second doctor came up, he said-he looked at me-he said to me, 'Lift your arm, lift your leg.' I said, 'I can't.' He said, 'You've had a stroke.'... You think, how do they do-and they're so cold at hospitals, you know? 'Oh, you've had a stroke,' and walk away."
Clinical care The people in this sample expected doctors to know exactly what was wrong with them, and in all but three cases their expectations were fulfilled. As one woman said with satisfaction: "Anyway, she [sister] came over and sent for the doctor, but
he was very good. He knew what was wrong with me. He told them exactly what was wrong."
The acute stage of stroke may be a bewildering and shocking time for a patient, but health professionals have a set response to this crisis. Patients and carers appreciated being able to hand over responsibility to a team of people who could take decisive actions on their
behalf. The following two comments illustrate patients' appreciation of the combination of knowledge and expertise that they felt was on hand at hospital and which helped them make sense of the stroke: "It was the first time I had seen a stroke, I didn't know what a stroke was. And at the hospital they gave me medicine, and exercises, and the doctor was telling me it was a stroke and that slowly it would get better." "When you've had that stroke and you need the hospital for their help, the nurses know exactly what to do, the doctors know exactly what to do. The physiotherapist knows what to do."
Most of those who referred to clinical aspects of care were positive. People generally seemed to have realistic expectations about what acute care after stroke consisted of, with few seeming to foster a belief in a "magic bullet." For example, one man felt that he would have recovered if he had simply stayed at home after his stroke; nevertheless he appreciated being admitted to hospital because it made him aware that tests were being conducted to find the underlying cause of the stroke and that people were interested in his
condition: "Well I actually think, it does boost you, it does give you that extra boost 'cause you know people there are trying to help. Whereas if you-presumably, I mean if I'd just stayed at home, hopefully it would have got better of its own accord, but... [PP: How does it boost you?] Well the fact that people are trying to find out sort of why it's happened and, you know, it just gives you that added extra."
Routine tests seemed to provide reassurance: "They said that she'd had a mild stroke. The scan showedthat it wasn't anything very serious, you know. No, nothing positive shown on all the different scans. And they said that er, hadn't got anything serious and that, should she take it easy, she could overcome it."
Rehabilitation was generally not discussed in relation to the immediate aftermath of the stroke, but three people were positive about the help they received from physiotherapists at this stage. Nursing care With regard to nursing care, some people were thankful because their families were relieved of heavy or unpleasant tasks such as lifting and toileting during the acute stage. The chance to rest and relinquish responsibilities for cooking, cleaning, and shopping was also appreciated. As one person said: "They did everything for me, just tucked me up in a bed and they used to come and wash me and that, you know, bring me meals up and that...." Another woman appreciated the fact that she had been washed and cleaned by the nurses, since during the stroke she had become incontinent. The matter of fact way in which the nurses dealt with this lessened
her feelings of shame. A few, however, felt that good care was prevented by the inflexibility of the ward regime. Problems could arise if people attempted to introduce their own routines onto the ward. For example, a carer wanted to help feed his wife at mealtimes but was prevented from doing so outside of normal visiting times. Another wanted to help his partner while she was using the commode but was asked by the nurses to leave her alone: "Because, nobody looked after you more than I did while you were in. I don't need to be asked to leave the bedspace when they put you on the commode. I'd only stepped outside the curtain and-crash--on the floor. It concerns me because although they're rushed around trying to do things and that, it's the care of the patient that worries me.... If they couldn't do it themselves, then they should have let me stay there and hold you, not let you fall off the commode." These carers felt that their partners were not being
cared for adequately in hospital; however, when they attempted to compensate for this lack of care by
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conducting tasks that they would soon have sole responsibility for at home, they were obstructed by the institutional regulations. Information and advice Only four people mentioned information and advice in relation to their acute admission, but of the four who did, three were dissatisfied. One man was trying hard to give up smoking but felt that he was given unhelpful advice: "I mean I spoke to medical registrars in [the local] hospital, and one of them actually told me to carry around a cut up carrot; she said, 'Every time you want a cigarette just eat the carrot'! I mean you'd look well walking down [a main road in the east end] with a handful of carrots, wouldn't you?!"
Another felt that he had to "drag" information about his condition out of the nurses and doctors: "You go to hospital, you've got to ask everything, right, and I'm a worrier. If I don't know what's the matter with me, or don't know what's going on, I like to know the details."
Finally, one person complained that he did not receive enough advice about his partner's condition; consequently he was not sure whether he was damaging her legs or improving her mobility by encouraging her to walk. Discussion RESPONSE RATE
The main reasons stated for non-participation were the effects of ill health, which is not surprising, given the population studied. However, those who accepted were no different 6 months after the stroke from those who refused. At 12 months, those in the interview group were slightly less disabled, yet the level and the range of disability were still fairly high, as the median Barthel and Nottingham extended activities of daily living scores indicate. Given this range of disability and also the age, sex, class, and ethnic mix it is probably safe to assume that a reasonable spread of different viewpoints has been achieved, which in qualitative research is one of the most relevant concerns. 14 IMPLICATIONS FOR CARE OF PEOPLE WITH STROKE
In the immediate aftermath of stroke, patients and their families were shocked and frightened. At this point, their expressed needs were to hand over responsibility to experienced and trusted experts, who would help them make sense of the event, take all the actions necessary to ensure survival, and provide warmth and reassurance during the crisis. People appreciated being admitted to hospital because they felt cared about by staff, they gained reassurance from clinical and diagnostic procedures, and they were given support in everyday activities. Patients' needs during the acute stage of stroke will not necessarily be fulfilled only by hospital admission, but if acute care for stroke is attempted within the community, these needs will still have to be met in some way.
Although hospital admission may meet important psychosocial needs during the crisis stage, as time goes on the needs which evolve in the longer term may be neglected in the hospital,8 since it is organised on a model of acute care. As the stroke "career" evolves and the acute stage passes, patients and carers may increasingly desire support relating to rehabilitation, discharge, secondary prevention, prognosis, or domiciliary services. More information is needed about the stages of the stroke career so that care may be tailored to respond sensitively and flexibly to the different stages.
The positive aspects of acute care which patients reported here, such as expertise, support, and reassurance, should be borne in mind when developing new services such as stroke units. However, patients
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Key messages * The experience of chronically ill patients in an acute care setting is a relatively neglected area of research * Interviews with stroke patients, 10 months after admission, identified four components of care: being cared about, clinical care, nursing care, and information and advice * Hospital admission meets important psychosocial needs during the crisis stage * Positive aspects of acute care which patients reported should be borne in mind when new services, such as stroke units, are developed * The quality of interaction between stroke patients and health professionals may have an important impact on the recovering person's self esteem were not uncritical-indeed they highlighted areas where there is considerable room for improvement. Complaints that calls to go to the toilet are ignored, or that spouses are prevented from caring for each other in hospital should be taken seriously. While hospitals may offer hope and shelter in times of distress, they may also be approached with trepidation and it is likely that, for this generation at least, the legacy of large institutions is fairly strong; indeed several people referred to themselves as "inmates" during the inter-
views.
For some people, stroke leads to drastic changes in mind and body, challenging lifelong perceptions of self and identity.2' As such, the quality of interaction between stroke patients and health professionals may have an important impact on the recovering person's self esteem. Wade suggested22 and Anderson later echoed him,'2 that the nurses' input may be crucial: "Nurses are perhaps the most important profession, as they are with the patient throughout the 24 hours ofthe day. Through their handling of the patient, physically, emotionally and socially, nurses can probably do more good or harm than any other profession." This was bome out by the findings in this study; most of the "caring about" was done by nurses, yet at the same time several complaints were raised about the quality of nursing
care.
IMPLICATIONS FOR RESEARCH
In 1980 Ben-Sira distinguished between two different components of care: the affective, relating to the emotional and personal aspects of care, and the instrumental, encompassing the more tangible, physical caring tasks.2' The affective may be compared with the component we have referred to here as "caring about," which is borrowed from Parker.24 Previous evidence, which the findings from this study support, suggests that, although the affective and instrumental aspects of care are distinguishable, people seem to draw on both when evaluating their health care.25 Certainly the accounts of these stroke patients suggest that they were reassured by a combination of medical and nursing care and warmth and empathy. Although patients define care in this wider sense, focusing on the process as well as the results of care, most clinicians and stroke researchers remain concerned only to assess the outcomes of clinical care, using mortality rates and measures of function to do so. McKeown has said that a wide range of responsibilities lie within the remit of clinical medicine, including reassurance, treatment of an acute emergency, cure, care, and comfort.26 This broad spectrum of care coincides closely with the dimensions of care high-
21
lighted by patients in this study. If it is agreed that these are important and desirable tasks, then the dimensions of care discussed in this paper should feature more prominently in assessments of outcome after stroke. We acknowledge funding from the Stroke Association, the Research Unit of the Royal College of Physicians of London, and the North East Thames Regional Health Authority locally organised research scheme and the generosity of all the people we interviewed. 1 Brocklehurst JC, Andrews K, Morris P, Richards BR, Laycock PL. Why admit stroke patients to hospital?AgeAgeing 1978;7:100-8. 2 Wade DT, Langton Hewer R. Why admit stroke patients to hospital? Lancet 1983;i:807-9. 3 Wade DT, Langton Hewer R. Hospital admission for acute stroke: who, for how long, and to what effect? J? Epidemiol Community Health 1985;39: 347-52. 4 Wade DT, Langton Hewer R, Skilbeck CE, Bainton D, Bums-Cox C. Controlled trial of a home-care service for acute stroke patients. Lancet 1985;i:323-6. 5 Bamford J, Sandercock P, Warlow C, Gray M. Why are patients with acute stroke admitted to hospital? BMJ 1986;292:1369-72. 6 Mulley G, Arie T. Treating stroke: home or hospital? BMJ 1978;ii: 1321-2. 7 Isaacs B. Treating stroke: home or hospital? BMJ 1978;ii: 1640. 8 Young J. Community care allows patients to reach their full potential. BMJ 1994;309:1356-7. 9 Hoffman JE. 'Nothing can be done': social dimensions of the treatment of stroke patients in a general hospital. Urban Life and Culture 1974;3:50-70. 10 Christie D, Lawrence L. Patients and hospitals: a study of the attitudes of stroke patients. Soc Sci Med 1978;12:49-51.
11 Pound P, Gompertz P, Ebrahim S. Patients' satisfacion with stroke services. Clin Rehab 1994;8:7-17. 12 Anderson R The aftermath of stroke. The expenence of patienu and their families. Cambridge: Cambridge University Press, 1992. 13 Bury M. Health care and chronic illness: a sociological view. Health Care Analysis 1994;2:240-6. 14 Fitzpatrick R, Boulton M. Qualitative methods for assessing health care. Quality in Heakh Care 1994;3:107-13. 15 Gompertz P, Pound P, Briffa J, Ebrahim S. How useful are non-random comparisons in making decisions about purchasing stroke services? Age Ageing 1995;24:137-41. 16 Mahoney FI, Barthel DW. Functional evaluation: the Barthel Index. Maryland State MedJ 1965;14:61-5. 17 Nouri FM, Lincoln NB. An extended activities of daily living index for stroke patients. Clinical Rehabilitation 1987;1:301-5. 18 Hunt SM, McEwen J, McKenna SP. Measuring health status. London: Croom Helm, 1986. 19 Lum 0, Brink TL, Yesavage JA, Heersetma P, Ade YM, Rose TL. Screening tests for geriatric depression. Clin Gerontol 1982;1:37-43. 20 Pound P, Bury M, Gompertz P, Ebrahim S. Views of survivors of stroke on benefits of physiotherapy. Quality in Health Care 1994:3:69-74. 21 Kaufman SR. Stroke rehabilitation and the negotiation of identity. In: Reinharz S, Rowles GD, eds. Qualitative gerontology. New York: Springer, 1988:82-103. 22 Wade DT. Who looks after stroke patients? BrJHosp Med 1987;37:200-4. 23 Ben-Sira Z. Affective and instrumental components in the physician-patient relationship: an additional dimension of interaction theory. J Health Soc Behav 1980;21:170-80. 24 Parker RA. Tending and social policy. In: Goldberg EM, Hatch S, eds. A new look at the personal social services. London: Policy Studies Institute, 1981:17-34. 25 Williams SJ, Calnan M. Convergence and divergence: assessing criteria of consumer satisfaction across general practice, dental and hospital care settings. Soc Sci Med 1991;33:707-16. 26 McKeown T. The rok of medicine. Oxford: Blackwell, 1979.
(Accepted 2June 1995)
Topical non-steroidal anti-inflammatory drugs and admission to hospital for upper gastrointestinal bleeding and perforation: a record linkage case-control study J M M Evans, A D McMahon, M M McGilchrist, G White, F E Murray, D G McDevitt, T M MacDonald
Medicines Monitoring Unit, Department of Clinical Pharmacology, Ninewells Hospital and Medical School, Dundee DD1 9SY J M M Evans, research assistant A D McMahon, statistician M M McGilchrist, senior computer programmer G White, senior computer
programmer F E Murray, consultant physician D G McDevitt, professor of clinical pharmacology T M MacDonald, senior lecturer
Correspondence to: Dr MacDonald. BMJ 1995;311:22-6
22
Abstract Objective-To evaluate the relation between topically applied non-steroidal anti-inflammatory drugs and upper gastrointestinal bleeding and perforation. Design-A case-control study with 1103 patients admitted to hospital for upper gastrointestinal bleeding or perforation between January 1990 and December 1992 (cases). Two different control groups were used, with six community controls and with two hospital controls for each case. Previous exposure to topical and oral non-steroidal antiinflammatory drugs and ulcer healing drugs was assessed. Study population-The population of 319465 people who were resident in Tayside and were registered with a Tayside general practitioner between January 1989 and October 1994. A record linkage database containing all data on hospital events and dispensed drugs between 1989 and 1992 was used for this population. Main outcome measures-Unadjusted and adjusted odds ratios of exposure in those admitted to hospital compared with controls. Results-Significant unadjusted associations were detected between all three classes of drug and upper gastrointestinal complications. The significant association detected for topical non-steroidal anti-inflammatory drugs was no longer evident in analyses which adjusted for the confounding effect of concomitant exposure to oral anti-inflammatories and ulcer healing drugs (odds ratio=1-45; 95% confidence interval 0-84 to 2 50 with community controls; 1*06; 0*60 to 1-88 with hospital controls). Conclusion-In this study topical non-steroidal
anti-inflammatory drugs were not significandy asso-
ciated with upper gastrointestinal bleeding and perforation after adjustment for the confounding effects of concomitant use of oral anti-inflammatories and ulcer healing drugs. Introduction The use of oral non-steroidal anti-inflammatory drugs is associated with upper gastrointestinal complications, particularly perforated and bleeding peptic ulcer.' Meta-analyses suggest that the relative risk is about 3.0.2 Recent studies have shown this risk to be dose related.34 This is one reason why the use of topically applied non-steroidal anti-inflemmatory drugs is advocated as plasma concentrations of the drugs remain relatively low after topical application. Despite this, spontaneous reporting data from the "yellow card" system of the Medicines Control Agency' suggest that the risks of topical antiinflammatory drugs may not be negligible. For example, since July 1963 there have been seven reports of adverse events in the gastrointestinal tract after topical application of diclofenac, four with ibuprofen, one with ketoprofen, 25 with piroxicam, and 47 with felbinac (an active metabolite of fenbufen) (Committee on Safety of Medicines, personal communication). Furthermore, in a post-marketing study of 23 590 patients exposed to topical felbinac 3% gel (Traxam), 327 patients experienced 331 adverse events, of which 24 were related to the gastrointestinal tract.6 This study may have been confounded by the use of other drugs as 17 of these patients were taking additional medication. Nevertheless, six cases were judged to be "definitely" or "probably" related to the use of topical nonsteroidal anti-inflammatory drugs.
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