Family Practice Vol. 20, No. 5, 538-544
© Oxford University Press 2003
Information in practice |
Finding a vein or obtaining consent: a qualitative study of hepatitis C testing in GP methadone clinics
School of Primary Care, University of Manchester, Rusholme Health Centre, Walmer Street, Manchester M14 5NP, UK.
Correspondence to Mark Perry; E-mail: msperry{at}man.ac.uk
Perry M and Chew-Graham C. Finding a vein or obtaining consent: a qualitative study of hepatitis C testing in GP methadone clinics. Family Practice 2003; 20: 538–544.
Received 11 November 2002; Revised 8 May 2003; Accepted 19 May 2003.
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Abstract |
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Background. Informed consent is a professional norm, but the promotion of testing for infectious disease in organized clinics and the introduction of targets for uptake, such as those for human immunodeficiency virus (HIV) testing in antenatal clinics, might impair truly voluntary consent. Hepatitis C virus (HCV) is highly prevalent among intravenous drug users (IDUs) and the ‘offer’ of a serological test for HCV antibodies is now seen as a national standard within drug misuse services, including GP methadone clinics. We hoped that GPs’ descriptions of the context and offer of HCV testing could provide an exploratory study of consent within primary care clinics.
Objectives. The aim of this study was to understand GPs’ ethical practice when negotiating consent to HCV testing with IDUs.
Method. A qualitative semi-structured interview study of 20 GPs in Greater Manchester was carried out.
Results. GPs reported that they or their attached drug workers commonly tested for HCV, and many stressed the need for good teamwork and building relationships with ‘stable’ IDUs before testing. GPs’ views on the beneficence of testing and their practices in obtaining consent were diverse. GPs’ discourse highlighted important management problems: (i) the adequacy of preparation of some IDUs for testing; (ii) ‘opportunistic’ HCV testing; and (iii) GPs’ recognition of denial after testing. While GPs offered little explicit ethical reflection, occasionally they remarked on tendencies to control a patient’s decision, and a deviant case analysis demonstrates how poor teamwork can be associated with coercion.
Conclusion. GPs’ descriptions suggest that an effective informed consent process is the norm for HCV testing within GP methadone clinics. Importantly, a minority of GPs alluded to the directive effect of team protocols or other problems in obtaining valid consent. We offer recommendations for managing testing to ensure voluntary choice.
Keywords. Coercion, hepatitis C, informed consent, primary health care, substance abuse, intravenous.
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Introduction |
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Obtaining informed consent from a patient before testing for blood-borne virus (BBV) infection [human immunodeficiency virus (HIV) or hepatitis] is considered to be a professional norm. However, it might be argued that there should occasionally be exceptions to fully ‘voluntary’ consent when a professional can legitimately ‘direct’ a patient’s decision. A clear example occurs in secondary care antenatal clinics, where third party interests (of the fetus) have legitimized the introduction of targets for the uptake of HIV testing.1,2 Consequently, some clinicians view antenatal HIV testing as a routine, from which women may consent to opt out.3 Women’s involvement in much decision making within antenatal clinics has been characterized as ‘informed compliance’,4 and there has been wide variation in HIV testing rates.5
There have been few empirical studies of GPs’ ethical perception and practice,6 and little is known about informed consent in primary care. GPs who regularly see intravenous drug users (IDUs) might be atypical, but this group provides a focus for an exploratory study of the operation of consent in primary care-based clinics. This report offers GPs’ descriptions of antibody testing for an infectious disease, hepatitis C virus (HCV), and their experience of the consent process as ‘critical incidents’ for analysis.
Previous research
The European literature indicates that tacit consent is sometimes assumed to be given by passive and institutionalized patients in primary care,7 and non-consensual HIV testing is reported.8 A US study showed that while doctors described the nature of decisions to patients, they often omitted other elements of consent, including checks on understanding.9 Holm suggested that work pressures, poor team communication and the development of routine ‘solutions’ are all factors in doctors’ non-recognition of ethical problems.10 Research based on localities overlapping with our study area11 and elsewhere has demonstrated GPs’ lack of confidence in managing drug misuse.12 We sought to discover whether the known difficulties of drug misuse work could influence GPs’ interest in, and ability to involve, patients in the decision to test.
Hepatitis C and an ethical synopsis
Antibodies to the RNA virus HCV are highly prevalent (at least 30%) among IDUs, and chronic infection, usually asymptomatic, is present for most of these. A minority will progress to serious disease, although there is not always urgency in treatment. There is no vaccination to prevent HCV and, in marked contrast to hepatitis B and HIV infections, the rates of sexual and vertical transmission to third parties are relatively low (5%).13
A discussion of the beneficence of HCV testing for IDUs themselves is not our focus and is limited here. However, as with HIV testing in pregnant women, an argument for the protection of others through ‘directive’ testing might exist in specific cases. However, the case for the ‘directive’ testing of all IDUs, in the interests of third parties, is weak. After HCV testing, there may be a modest reduction in sharing injecting equipment (the main route of infection), but testing may not be causal.14 So it might be claimed that, in contrast to ‘directive’ HIV testing in antenatal care, most ‘directive’ HCV testing of IDUs would be motivated by paternalism (acting in ‘best interests’). However, the General Medical Council (GMC) advises that consent to testing for infections should ensure respect for autonomy,15 that doctors have a duty to involve team members, present a balanced view and to allow time for decision making.16 Official UK guidance issued during this study (2001) simply promoted access for those ‘who seek testing’, offering an overview of the process and team roles involved.17 Subsequent to our fieldwork, an English Department of Health consultation document on hepatitis C strategy has proposed that the routine offer of an HCV test to IDUs to identify those infected should now be the national standard and that testing rates should be monitored.13 While the consultation document shows that IDUs could be empowered by knowledge of their serostatus, it also appears to herald a policy shift that might be interpreted as advocacy of ‘directive’ testing.
‘Shared care’ clinics
Within practice-based methadone maintenance (MM) clinics, drug workers see IDUs frequently (2–4 weekly) often over years, controlling the dose and frequency of prescribing, while GPs offer medical and preventive services. Official guidance on consent suggests that involuntary detention is the main threat to free decisions;18 however, on entering MM clinics, IDUs could be said to submit to an informal contract allowing ‘harm minimization’.19 The latter is partly achieved through ‘weak’ paternalism.20 This is defined here as the justified prevention of self-harm that could be incurred by a patient’s non-autonomous actions. Such diminished autonomy would usually be transient, perhaps if an IDU was intoxicated. Hence it could be argued that ‘weak’ paternalism only justifies urgent interventions, typically tighter control of methadone dispensing, or its supervised consumption to prevent drug-related harm, such as overdose. Setting third party interests aside, if professionals were to influence choices (such as HCV testing) that could reasonably be made over time with a degree of autonomy, then such interventions would be inconsistent with respect for autonomy. Overriding autonomy constitutes ‘strong’ paternalism.
Variations in the organization of GP ‘shared care’ will be described, but the timing of testing could influence IDUs’ voluntary engagement. One example of the potential for different practices is highlighted below from the current UK guidelines on drug misuse management.19 The suggestion that serotesting occurs before hepatitis B immunization might be interpreted to also include routine HCV testing:
"It may be unwise to delay administration of the first dose of vaccine whilst awaiting test results; should a positive result then be obtained, it can be discussed with the user and immunisation discontinued." [Drug Misuse and Dependence—Guidelines on Clinical Management, Department of Health, 1999. www.doh.gov.uk/drugdep.htm Annex 7, pp. 89–93. p. 91.]
The standard of competence required to decide on HCV testing may be higher than that necessary for hepatitis B immunization, because the implications of a positive HCV test are more complex. Could the organization of clinics result in pressure on IDUs? If testing was proposed when IDUs were negotiating acceptance, it might appear to them to be simply part of the care package.
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Method |
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GPs were sampled in alphabetical sequence from three Greater Manchester Drug Services’ (denoted below as: Manchester, M; Trafford, T; and Stockport, S) area lists of practices offering methadone prescribing. Twenty GPs were interviewed about testing for HCV with a focus on informed consent. Elements of the consent process (giving information, checking understanding, the use of time and degree of control over IDUs’ decisions) were explored, as were the structure of clinics and team roles (Appendix 1). Although, as described elsewhere,21 MP as field researcher tended to be seen as an ‘expert’, his relationship as a GP colleague allowed ‘private’ themes22 to emerge and enabled the catharsis required for a significant deviant case.
The interviews were taped (with consent) and the transcribed interviews were subjected to constant comparative analysis by the authors until category saturation was reached. Both during the interviews and in reviewing the transcripts, the researchers sought disconfirming evidence, especially when an account seemed to confirm one hypothesis that early HCV testing occurred. A respondent’s revision then often indicated that a potential for voluntary testing existed. Both ‘a priori’ theory and the emergent categories were mutually ‘adapted’ throughout the research process (Layder’s ‘adaptive’ theory).23 A written invitation to the GPs to comment on a draft of this paper complemented earlier respondent validation within the interviews.
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Results |
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Of 40 GPs approached, 20 (Manchester 14, Trafford four and Stockport two) gave written consent to participate in the study (50%). Non-responders cited workload and media criticism (2000–2001) of methadone-prescribing doctors as reasons for non-participation. Respondents broadly matched the sample frame characteristics in age, gender and ethnicity, and worked in a range of city and suburban practices. Almost all offered shared care services through a regular community drug team (CDT) clinic within the practice, where the numbers of current or recent IDUs regularly seen ranged from 10 to 150.
There is no reason why respondents should not have been typical of GPs managing drug misuse, but they were dissimilar to GPs overall: a previous survey of Greater Manchester GPs suggests that only 
20% will encounter >10 IDUs annually.24 While few respondents cited formal drug misuse training, some described expertise (secondary care posts, prison or homeless-ness medicine and research). Almost all respondents were RCGP members, including several GP trainers and a member of a Local Research Ethics Committee.
Ethical concerns were not foremost among the wide range of iterative themes that emerged in response to the interview prompts. Our focus is upon those themes relevant to the consent process, but we trust that others, such as workload and the difficult dynamics of drug misuse work, will become apparent.
Patterns of ‘shared care’ in the clinics
Some GPs served settled communities and families, while others saw more transient IDUs. All but one of the practices operated clinics staffed by CDT drug workers, but GPs’ involvement varied. Often this involved some ‘open access’—the GP was available to consult with the CDT workers or IDUs during the clinic. Such GP responsibility for general medical and preventive care within ‘shared care’ clinics has long been formalized within one area (Trafford), while the development and pattern of services across Greater Manchester has been described elsewhere.25 Other GPs, mostly from Manchester itself, described more detached working, so that a few apologized for simply signing methadone prescriptions, a form of devolved secondary care.
Experience of HCV testing related to GPs involvement in the clinics, and five of the Manchester doctors had tested few patients themselves, perhaps partly because there was also a dedicated HCV service at a central Manchester location. In contrast, most Trafford GPs described HCV testing as a proactive CDT policy within the practice. GPs’ proactivity and testing activity thus tended to reflect the policy and provision of their local drug service. However, while Trafford GPs were in regular contact with IDUs, two of them appeared to distinguish their own role as being more reserved, or reactive, in offering testing.
". . . with CDT it is part of their protocol. They like people to get the test...the CDT are probably a bit more pushy about it than I am . . ." Dr 19T
Workload and pressures
GPs often began the interviews unprompted, by contrasting ‘shared care’ with the tensions and workload that had preceded the clinics. The apparent requirements of testing challenged few practices but, because of CDT input, GPs could feel distanced from the patients, and apologies for perceived shortcomings in medical care emerged as ‘asides’, as in the following account, discussing consent.
". . . often when the current methadone users come in they’re in a bit of a hurry, so I don’t know whether we do it as thoroughly as perhaps we should do." Dr 14M
Time and teamwork
CDTs were commonly described as a management filter that moderated drug users’ demands, and the pattern of frequent consultations helped to increase drug users’ understanding prior to testing.
"They have usually thought about it . . . They will see the drug worker one week and then they will eventually trail in to see me..." Dr 4T
A few GPs were explicit about using time to confirm a drug user’s voluntary intent to take a test, especially if the issue was raised at clinic entry. This doctor used the analogy of minor surgery.
". . . with all the minor ops, . . . I explain the procedure . . . They’ve got the opportunity to walk out, and they DO walk out. Then they’ve got the choice about whether they come back . . ." Dr 19T
However, time could also be incidental to the consent process—the difficulty in obtaining a blood sample appeared to be the prompt for doctors to defer testing. However, allowing for the possible reservations of two Trafford doctors (above), GPs indicated confidence that an effective informed consent process operated when team roles were clear. This was the norm, though duplication was described.
"Occasionally someone wanders in . . . and says, ‘The drug worker sent me’. I tend to ignore the fact that he’s probably done an immense amount of work and go through my own little ritual." Dr 17S
Two GPs clearly associated HCV testing with hepatitis B immunization and implied that these were necessarily linked in time.
"I don’t think its coercion. It relies on bringing everything together and making it very easy. If you have a drug worker who says, ‘Look, you could have your blood taken now, you can have your first dose of hepatitis B’, we can do it all together . . ."
". . . Ideally you would . . . give them some time . . . but that is not usually practical!" Dr 15M
Some doctors viewed delay as an impediment to testing, which became opportunist because it was felt that drug users would not return voluntarily. Linking testing to prescribing was seen as facilitating access.
". . . I’d say, ‘Well, we’ve raised an important issue today . . . I’d like to discuss this again with you when you come next time,’ and make sure that I only give them enough . . . of something they want, like their tablets, and that they can’t get them on repeat . . . it’s using what they want to get what I want. But you could say that’s not consent." Dr 16S
In the two previous accounts, GPs reflected on their tendencies to control a drug user’s decision, although explicit description of the use of repetition or repeat prescribing to encourage and increase testing uptake was unusual.
Proactive or reactive
There was a clear divide between doctors who preferred to respond to an IDU’s request to test and proactive GPs, along with those discussed above, who expected their team to promote tests. Reactive attitudes were linked to a view on the limited value of interventions. This doctor served a transient population.
"We shouldn’t screen for diseases where there is no effective intervention . . . People who ask for it are generally a bit more stable." Dr 7M
GPs’ proactivity thus also related to the perceived ‘stability’ of the individual, while a few seemed to construct the ethical issues as primarily those of beneficence.
"For me, I think it’s always better to know than not know." Dr 15M
Similar discourse described a doctor’s or team stance, and ‘directive’ testing was suggested by ‘vigilance’ and ‘persuade’, or the IDU’s response: ‘refusal’. In contrast, in Manchester, preventive work could centre on hepatitis B immunization alone.
". . . the policy was not to pre-test people . . . They just gave it to them . . . And not address the hepatitis C issue at all."
". . . It’s not a very definite message you are giving . . . A lot of these people are rushing round anyway. Chaotic lives."
". . . Unless a clear message comes out. A clear way of picking up people for treatment . . ." Dr 6M
These comments, from a doctor with a large clinic, suggest that ‘best interests’ were considered served by not discussing HCV testing.
Culture and relationships
Pre-test counselling seemed easier in localities where drug users were linked with an informed network of IDUs. However, in areas with small pockets of resident, rather than transient drug users, disease awareness could be lower and the GP later found it hard to share the diagnosis.
"We’ve not got an aware population here. The few people I’ve had to deal with, it’s been hard work . . . quite a shock." Dr 19T
This doctor also felt he knew the backgrounds of patients who would be likely to enter his clinic during the coming year. Establishing such relationships was considered important in preparing drug users for a test, and both patient turnover and staff changes were factors that could impact negatively on relationships.
". . . she (the drug worker) knew the client population very well . . . exactly what was needed . . . she has moved on . . . So the continuity hasn’t been quite as good." Dr 4T
Preparing for a positive and recognizing denial
Although GPs had rarely encountered bad reactions, preparing the IDU for the likelihood of a positive result was considered important. Two accounts described adverse reactions from IDUs with previous experience of negative HIV tests.
"I did say to him, ‘Of these, the hep C is much more likely to be positive’. The HIV was negative, but the hep C positive. Then he was quite devastated . . . he took ages to come back for his results . . . maybe he still felt he was going to be negative." Dr 7M
Denial could be seen as a barrier to informed consent and therefore to testing, but GPs could also accept it as a norm, with two important consequences. This GP may have felt that denial would compensate for any failure to confirm understanding.
"Either they understand that they’re going to address their lifestyle, or they don’t understand and it will make no difference . . ." Dr 19T
Secondly, if denial only became apparent after testing, it allowed a pause in the process of discovery.
"People don’t come back for the results and we can do it all again . . . It’s a brilliant safety signal . . . they come back when they want . . . I am not into chasing them . . ." Dr 17S
Within the setting of ongoing appointments, allowing patients to receive results ‘when ready’ is a departure from the formal and urgent HIV model of planning post-test consultations.
Few GPs had been involved in HIV testing. However, while GPs often acknowledged a need for pre-test HCV counselling, several were critical of replicating formal HIV testing services. This was either because they saw testing as routine work, or because they wished to ‘own’ the process.
". . . this counselling industry that came up with HIV was fascinating. Most people don’t need it." Dr 17S
Other doctors wanted training, or a dedicated testing service.
"Most of this we just picked up by reading. It’s not proper . . . I would much rather it was done by experts." Dr 13M
A deviant case analysis: negativity and control
A single deviant case offered an insight into the way that a GP’s negative attitudes could affect his/her behaviour. It is important to note that this doctor’s reluctance to work with the drug team was associated with repetitive ‘offers’ to a captive population of IDUs that were seen in his own surgery time during the initial weeks of contact. This GP then transferred ‘care’ to the CDT clinic, or ‘got rid’ of chaotic patients.
". . . I feel very negative about this issue in general practice, so I’ll tell anybody anything, as loud as I like. To get rid of this bloody thing!"
". . . I am fairly strongly against this shared care."
". . . I don’t want my families upset by the behaviour of the addicts . . ." Dr 11*
The doctor (*anonymous) perceived a duty to be owed towards families, to whom he is protective, as distinct from ‘addicts’.
". . . We have two waiting rooms—to isolate them from the main general practice crowd."
". . . I keep bringing it up while I have got them. Then they go to the drug team and they are not interested . . ."
". . . Obviously if I can do it then and there, I will. But usually that first consultation is a long one . . . I am not usually in a position then to start thinking about drug addicts’ veins!"
". . . I am going to lose that window of opportunity later. You see people week in, week out . . . just scripting. There is nothing very original about the consultation." Dr 11
We are struck by the doctor’s need for a ‘positive’ role, introducing a disease agenda to legitimize his behaviour within an otherwise uninteresting series of consultations. Teams who offer drug misuse care can express negative attitudes about aspects of this,26 and doctors’ involvement may be motivated by the creation of a medical agenda.27
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Discussion |
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GPs are encouraged to manage drug misuse, and their training needs are recognized.28 GPs’ experiences with IDUs at different levels of recovery and social stability have probably contributed to diverse perceptions of the benefit or futility of HCV testing, but our critical focus here is on an example of consent in primary care.
GPs described various ways of sharing the responsibility for obtaining consent over time between the drug worker, the GP and occasionally the practice nurse. For most GPs, good team-working and well-established relationships with patients meant that there was no suggestion of control over an IDU’s decision—there was no ethical problem. Others perceived a potential for coercion and used time to ensure that the drug user was engaged voluntarily, but this solution was not always apparent or acceptable. The deviant case analysis suggests that health professionals who lack trust in teamwork, or hasten the consent process to meet their own agenda, may become coercive. While this study indicates that teamwork may be important in implementing consent over time, we only interviewed doctors, and our conclusions about drug teams are tentative.
Doctors expressed uncertainty over the extent of sexual and vertical transmission of HCV. Although few doctors were explicit about testing in third party interests, this could be one reason why some descriptions suggested directive testing.
The range of views on the beneficence of testing and, in one area, the presence of a team protocol appears to have contributed to a spectrum of practice. Perhaps doctors at either extreme were describing paternalistic practices. These operate if doctors either assume a lack of benefit from intervention, so failing to raise IDUs’ autonomy and awareness to enable testing, or conversely if they, or their teams, convey an expectation of testing.
Analysis of the data also leads us to highlight three practical issues that are relevant to GPs’ everyday implementation of informed consent:
Simultaneous consent
Testing for HCV, as well as HBV, concurrent with administering a first dose of hepatitis B immunization, soon after the patient’s entry to the clinic, seemed problematic to some doctors. Clearly consent should be disease specific, and more complex decisions are likely to require more time. Perhaps the UK Department of Health guidelines should clarify that sero-testing could be raised as a separate issue from immunization.19
Preparation
GPs commented on two patients’ apparently worse reactions to a positive HCV test following previous experience of negative HIV testing. Previous reassurance could have been a factor in such adverse reactions, and health professionals need to remember to check expectations before testing.
Denial
Doctors’ description of IDUs’ failure to discover their test results emphasizes the importance of managing denial before testing. Post-test denial would not necessarily be associated with a lack of either pre-test understanding or intent. However, if there were no pre-test checks on these, the clinician’s possession of information, prior to giving the results, would be non-consensual.
GPs recognize that introducing HCV testing creates training and service needs, but their desire for involvement varies and many may refer patients for testing, thereby ensuring their voluntary engagement elsewhere. Alternatively, testing within shared care could offer IDUs ease of access and supportive relationships, both probably important in empowerment to testing and in follow up. The pro-active policies of some drug teams are no doubt necessary to raise drug users’, and perhaps also GPs’ awareness. However, where the whole consent process occurs in one clinical setting, testing ‘offers’ could be experienced by IDUs as directive. The timely offer of a test is important, but plans to monitor the uptake of ‘increased testing’13 might encourage coercion. Teams could reflect on who is ‘in control’ of a decision to test, actively using time to ensure that control rests with the drug user.
Although previous research has pointed to some reasons for non-consensual practices in primary care,7,8 we have described other ways that these occur. Paternalistic assumptions about the beneficence of testing or the lack of it seem to be held by both apparently well-developed and proactive teams and GPs working in less formal arrangements, where any protocols for offering testing appeared to be less clear to doctors. Our analysis suggests that paternalism may creep from a context where the prevention of imminent harm is justified (prescribing) to cause an unjustified restriction on either IDUs’ enablement or on their voluntary engagement.
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Conclusion |
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This study indicates that health professionals should consider the effect of the introduction of clinics, protocols and targets on the effectiveness of the consent process. Guidance on situations calling for more ‘directed’ consent could be made explicit within protocols, but our findings concerning GPs’ ethical perception suggest that training may be beneficial when new structures and processes develop within primary care.
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Appendix |
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Interview schedule
Introductory discussion: hepatitis C is highly prevalent among intravenous drug users, (IDUs). There may be a range of approaches to counselling and testing for hepatitis in primary care. This interview is intended to clarify existing patterns of practice and the ways in which we as GPs can know that IDUs offer valid consent.
Process
How many new patient contacts with IDUs does your practice have each month?
Does your practice offer advice on, or testing for hepatitis C to IDUs?
If you do so, who is involved?
drugs worker/doctor/practice nurse.
Consent
In counselling about hepatitis C, what areas do you usually cover?
What factors are important for you in determining whether an IDU has given informed consent to testing?
How often do they go away and come back?
How do IDUs arrange appointments for testing at later consultations?
Have you regretted offering or performing a test?
Do you find IDUs have misconceptions?
Is there anything else you want to talk about?
How do you feel about being interviewed by a colleague?
Background data
Age/date of qualification and postgraduate qualifications
Partnership and list size
Postgraduate courses relevant to drug misuse or medical ethics
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Acknowledgments |
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We are grateful to the GP respondents, Rebecca Bennett and Jan Lang.
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References |
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