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British Medical Bulletin 57:193-206 (2001)
© 2001 Oxford University Press
Treatment delivery and guidelines in primary care
Depression and public health
Community Clinical Sciences Division, University of Southampton, Southampton, UK
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Abstract |
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Top
Abstract
IntroductionBecause depressive illness is so prevalent, the majority of patients are managed in primary care, without recourse to specialist services. Primary care management is seen to fall short of the standards set in secondary care, but unfortunately there is as yet relatively little evidence from primary care to guide management in this distinctive patient population. Guidelines have been introduced as a means of quality management, and their value in improving care has been assessed in trials. To date, the benefits of the implementation of guidelines have been marginal at best. By contrast, strategies which improve the access of patients to specialist services do seem to be beneficial. There is also evidence that such strategies may be associated with ‘cost-offset’. Choice of antidepressant medication for maximum cost benefit should also be informed by an evidence base, which is beginning to be accumulated. Further research on this topic in the primary care context is still needed.
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Introduction |
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Depressive illness is a major public health problem, affecting 5–10% of the population annually, and associated with significant social and occupational disability. Because of its high prevalence, it is mostly managed in primary care, with only a minority of cases referred for specialist assessment and management1
. Until recently, however, few general practitioners (GPs) in the UK or other countries have received training or specialist experience in the detection and management of depression and other common mental disorders. It is, therefore, not surprising that evidence has accumulated that depressive illness often goes unrecognized in primary care, and even when it is recognized it is often sub-optimally managed2. The evidence that treatments for depression are effective has almost all been gathered from secondary care, where the majority of large randomized treatment trials have been carried out. Such trials have inevitably recruited patients who have more severe or enduring depression than those usually encountered in primary care, raising doubts about the generalizability of their findings to primary care. However, until evidence is available directly from primary care trials, concern persists about the failure to deliver treatment consistently with current best evidence.
The nature of practice in primary care brings particular difficulties, as well as opportunities. GPs do have the advantage of continuity of care, but usually work under considerable time pressure, with an average consultation time of only 8 min, and have to deal with the full range of physical and psychological aspects of medical care. The current diagnostic criteria for offering treatment were also developed in specialist practice and, like any criteria developed in secondary care, will have a lower positive predictive value in primary care, due to the relatively lower prevalence of the disorder3. This means there is a greater risk of ‘false positives’. Because of concern about the consequences of labelling people as depressed unnecessarily, primary care practitioners tend to set a higher threshold for diagnosis4.
Even when GPs do decide to offer treatment, they find that many people think antidepressants are addictive, do not like taking higher doses, and tend to want to stop treatment as soon as they start to feel better5,6. Such attitudes are, of course, far less common in patients who have already accepted referral to secondary care. The remainder of this chapter relies heavily on research comparing primary care practice with standards derived from specialist secondary care settings. The body of research evidence available directly from primary care is relatively much smaller, although now growing more rapidly.
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Under-recognition of depression |
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It has been reported that depressive symptoms are not recognized in around 50% of attending patients with depressive disorders (ascertained by research diagnostic interview) in UK general practice7
–9. Similar findings have been reported in the US, with detection rates found to be lower in patients in pre-paid health plans than for those in fee-for-service plans10. It is important to note though that many of these patients are actually consulting with physical symptoms, and furthermore, whilst depression may not be detected on a single visit, a proportion of the cases missed on that visit may be detected subsequently11.
The actual proportion of treatable depression that is missed overall is, therefore, hard to estimate accurately, but most of the ‘missed cases’ are probably close to the threshold for diagnosis, and GPs probably recognize the large majority of patients with more severe depression4. For example, more than half of the undetected patients in one study had mild depression (low Hamilton rating scale scores and better social functioning), whereas only 7.5% of the missed patients were severely depressed12. It should be noted, in addition, that depression may also be recognised but not recorded13, perhaps because of the stigma attached to the diagnosis, or its implications for possible increases in insurance premiums or difficulties obtaining or maintaining employment.
The clinical significance of non-recognition has also been questioned, with some experts suggesting this has been overstated14,15. Such findings are difficult to interpret, however, if recognition is not always followed by optimal management. Problems are also created by the tendency of the literature to regard depressive illness as a categorical diagnosis, without regard to the continuous distribution of severity and chronicity of depression observed in population studies16. The clinical utility of the diagnostic categories used by specialists requires further evaluation in primary care.
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Quality of treatment |
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Antidepressant medication, brief focused psychological treatments and social interventions all have evidence to support their use in secondary care patients. In primary care, medication tends to be the mainstay of treatment, but there is evidence that it is often given in doses below those shown to be effective, and for periods shorter than those which have been shown to be necessary to prevent relapse and recurrence17
. Non-drug treatments are also under-used, usually because they are difficult to access from primary care as a result of under-provision.
Most authorities believe that a categorical diagnosis of ‘major depression’ (DSM-IV)18 represents the threshold at which antidepressant drug treatment is more effective than placebo. It is important to note, however, that the only direct evidence for this in UK primary care comes from a post hoc analysis of sub-groups with major and minor depression in one relatively small trial of amitriptyline19, and may need to be revised in the light of further evidence. Further suggestive evidence supporting the use of this threshold comes from two studies, one of collaborative management20 and one of compliance therapy21 in which outcome was improved only in major depressive disorder subgroups.
Another ‘structural’ difficulty in primary care is that arrangements for routine follow-up, audit and monitoring of treated patients are not well established. Quality control of care is, therefore, difficult to establish even if adequate treatment has been commenced. Disease registers and special chronic disease clinics may represent a partial solution to this problem, but may be constrained by re-imbursement systems22.
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The proliferation of guidelines |
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In the light of the apparent shortcomings of primary care management, two principal approaches to improving the care of depressed patients in general practice have evolved. One is to improve care delivered by the primary care team, and the other is to improve access to specialist management. Initial efforts to improve care were largely focused on education of GPs in the disease area23
. However, in the past decade, clinical guidelines have come to the fore as a potential vehicle to increase the impact of education and to support quality improvement initiatives. In 1992, the Defeat Depression campaign was launched, heavily based upon the first UK national guideline2. Similar initiatives and guideline development have taken place in other countries, including the US24,25.
Ideally, a clinical guideline should take the form of a systematically developed set of statements designed to help practitioners and patients make decisions about appropriate health care for specific circumstances and should be based upon current best research evidence26. Initial attempts to produce guidelines often had significant weaknesses, and there are now clear guidelines for guideline development27, accompanied by methods of assessing their quality. In short, guidelines have to be simple, specific and user-friendly with a focus on key decisions if they are to be used in routine practice; they must demonstrate how they are derived from research evidence in a way that is relevant to decisions about individual patients; and the evidence and recommendations must be presented in a concise accessible format.
A systematic review28 concluded that guidelines were most likely to be adopted if local clinicians were involved in their development and had a sense of ownership; if they were disseminated through a specific educational programme; and were implemented with patient-specific reminders available during actual consultations. Attempts to introduce guidelines need to take account of best methods of dissemination, benefits and barriers to adoption, the extent of perception of need for change (i.e. recognition of unsatisfactory quality of existing care), the relative priority of the clinical topic, and the usefulness and ease of use of the guideline.
Unfortunately, guidelines may come to have purposes beyond simply enhancing clinical care, often being used as management tools by purchasers and providers of care to contain costs, and having inescapable legal and ethical consequences. This inevitably has had an impact upon their reception by health professionals, and may impede the purposes for which they were originally developed. Thus the development of a high quality guideline does not necessarily ensure its adoption in practice and automatically lead to improvement in quality of care. The costs of producing a guideline, though high, may be dwarfed by the costs of implementation and dissemination.
In the UK, GPs have been described as suffering from a ‘tidal wave’ of guidelines, with over 2000 guidelines or protocols for different clinical areas identified27. A useful review has assessed the quality of depression guidelines produced in Britain between 1991 and 199629. Forty-five guidelines were identified over this period, and a critical appraisal instrument was used to assess the quality of all nine nationally produced guidelines, and a sample of the 36 local guidelines. Most of the guidelines were heavily based upon the earliest UK national guideline2, adapted to reflect local priorities and circumstances. However, the known gaps in research evidence were clearly apparent in the review process. There was also considerable variation in the style in which information was presented to the clinician, ranging from in-depth discussion of latest research to simple lists of bullet points. The authors comment that debating the strengths and weaknesses of developing and using guidelines is a sterile exercise in the current climate, when the tidal wave shows no sign of abating.
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Existing guidelines |
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The first national guideline on the recognition and management launched in the UK2
was developed by a consensus conference, and drew explicitly upon available research evidence. Dissemination was via the regional organizations of the Royal College of General Practitioners, supported by a network of regional education fellows, and audio-visual materials including video, slides and booklets.
In 1993, the British Association for Psychopharmacology (BAP) produced their own guideline, with particular emphasis upon choice of drug treatment30. This guideline has subsequently been updated following a further consensus meeting in 1998, with the revised version being published in 200031. Also published in 1993, the Department of Health in England commissioned an Effective Health Care Bulletin on depression, from the Centre for Health Economics at the University of York32. This guideline was notable for its emphasis upon use of cheaper and older medications as first-line treatments. The North of England evidence-based guideline development project produced a further British guideline in 199933. Probably the most detailed current guideline is the American Agency for Health Care Policy and Research guideline (1993)25.
The range and scope of all the guidelines is broadly similar, considering the epidemiology of depression, the diagnosis of depressive illness, and factors affecting recognition. Guidance for clinical assessment, assessment of suicide risk and initial management usually follows, and the guidelines then discuss longer-term management and prevention of recurrence, with variation in the degree of detail about choice of medication, how long to continue it, and how to stop it. Other issues covered (more variably) include dealing with diagnostic uncertainty and treatment failure, the presence of physical illness, physical complications and side-effects of treatment, other psychiatric co-morbidity including psychotic symptoms, and guidance on when to refer for specialist management. The current version of the BAP guideline31 probably represents the best and most up-to-date guideline. Its recommendations are clearly summarised in helpful boxes within the text, and the explicit use of evidence is commendable.
Once guidelines have been developed and implementation has begun, it is necessary to address the thorny question of whether they are having any impact upon quality of care, and ultimately on patient outcome. There was preliminary evidence from the Gotland study that education of GPs led to improved patient outcome in terms of reduced sickness absence, hospital referrals, and an apparent fall in the suicide rate on the island, mirrored by a rise in the prescribing of antidepressants23. This evidence was based upon a before-and-after comparison rather than a controlled study, however, and the benefits seemed to wane quickly once the intervention was withdrawn34. Many evaluations of guidelines have concentrated upon improving the process of care35,36 making the assumption that improved care must lead to better outcomes. Such an assumption may be unwarranted, however, and there is an obligation on researchers to tackle also the difficult task of seeking benefits in terms of outcome.
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A study of guideline implementation: the Hampshire Depression Project |
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The only study in the UK to date which has attempted to evaluate the implementation of a guideline in terms of both quality of care and patient outcome was the Hampshire Depression Project37
, a pragmatic randomized controlled clinical trial of the implementation of a clinical guideline modelled upon that of Paykel and Priest2. It was based upon three assumptions: (i) that cases of depression can be reliably identified; (ii) that effective treatments can be generally applied; and (iii) that it is possible to modify the behaviour of health professionals through supported education. The main hypotheses tested were that a group of GPs who had received education built upon a clinical guideline would demonstrate improved recognition of depressive cases, and greater recovery rates in patients treated by their practice teams.
The guideline38 was presented to the multidisciplinary practice teams via a carefully chosen education team consisting of a GP, a practice nurse and a psychiatric nurse carrying out visits to the intervention practices. Videos, written materials, small group teaching sessions and role play were used, and the educational approach was validated by external educational experts as of the best possible quality likely to be affordable for generalised administration to all practices if it proved to be effective. Great care was taken in training the team to avoid at all costs the perception that the education consisted of ‘secondary care telling primary care what to do’. Sixty (out of 232) practices volunteered to take part in the study, and 59 were randomized to receive education immediately, or to wait to receive it in the second year of the study. Consecutive attending patients were screened, and practitioners were asked to indicate if they felt significant depression was present, to enable calculation of the recognition rate. Postal questionnaires at 6 weeks and 6 months were used to estimate recovery rates. The principal outcome variables were compared in the first year between educated and uneducated practices, both immediately after the end of the education sessions, and after a further period of 9 months. Attendance at educational events was good, and feedback from practice teams was strongly positive.
Although the guideline and education were regarded as being of high quality by external peer review, and the education team were perceived to be very helpful, competent and effective by participants, the main finding of the study was that they had no impact on the practitioners' ability to recognize depression, or on patient outcome. Recognized patients of educated practitioners did have better outcomes in the immediate aftermath of the education sessions, but this difference did not persist at follow-up, and was offset by a (non-significant) trend for unrecognized patients in the same practices to have worse outcomes.
There were no significant differences in the proportions of depressed patients prescribed antidepressants, or referred for psychiatric reasons, which might have supported the apparent improvement in short-term outcome. Levels of tricyclic antidepressant (TCA) prescribing were maintained at a significantly higher level in the intervention group, but antidepressant drug costs per patient treated were not significantly lower. Only 15% of those with possible, and 26% of those with probable, major depressive disorder were prescribed an adequate dosage and duration of treatment. Overall, the authors had to conclude that the apparent short-term benefit in patient outcomes in the intervention arm may have been a chance finding, and there were no significant savings in health service costs as a result of this relatively costly intervention.
The failure to observe any positive benefit could obviously have resulted from several factors, including limitations in the guideline itself, the design of the education, the delivery of the education or the design of the evaluation. The guideline was based upon current evidence, which has not changed dramatically since the study was conducted, and so cannot feasibly be improved upon at the present time. The educational approach followed the recommendations of Grimshaw and Russell28, and so again reflected best practice both at the time of the study and today. Increasing the intensity of education further would have compromised the generalizability of the findings. It is possible that only the most motivated practices decided to take part, and this may have imposed a ‘ceiling’ effect on potential improvement, but this is unlikely as the performance of the practices was not noticeably better than that reported in previous studies.
The inclusion of prevalent cases introduced a conservative bias for the estimation of outcome, but reflects the reality of the clinical setting, where chronic depression is a large part of the problem. Significantly, around 90% of depressed patients were on non-psychiatric medication, and around 40% were referred to non-psychiatric specialist out-patient clinics, suggesting a high level of physical co-morbidity. The participating GPs might well have thought that if they could solve their patients' physical problems through these responses they would also reduce their psychological symptoms. The doctors' behaviour, therefore, seems to be in line with recent exhortations that we should respect the role of physical health problems in determining psychological disability and not just apply non-specific treatment with antidepressants or referral for psychological treatment39,40.
An interesting post hoc finding of the Hampshire Depression Project was that the strongest predictor of both the prevalence of depressive illness and of its persistence was the measure of social deprivation of the area in which each practice was located41. This highlights the very important role of social factors in the causation and maintenance of depressive states, particularly for the less severely ill, and casts doubt on the statement in most guidelines that depression responds to medical treatment regardless of the influence of psychosocial factors in its causation. This effect is likely to be far more pronounced in a primary care population than in secondary care, and is an important area for further research. The results re-inforce the view that studies of implementation should not rely solely on the opinion of the participants or measures of process of care, but must include measures of patient outcomes.
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Other interventions to improve quality |
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In contrast to the apparent failure of guideline-based education of practice teams to yield significant improvement in patient outcomes in the UK, studies based upon delivery of intensified treatment to selected populations of patients with major depression in the managed care context of the US have shown benefits. Katon et al20
,42 were able to demonstrate that in such a selected patient population intensified care incorporating patient education, shared care between the primary care physician, psychiatrist and psychologist (using a cognitive-behavioural approach), and a relapse prevention plan were associated with improved treatment adherence and patient recovery rates. This improvement in outcome was accompanied by a cost-offset effect such that the additional costs incurred by intensified treatment were compensated for by the improved success rate, resulting in a lower overall cost per case43. In a further study, patients who had failed to respond to 6–8 weeks of routine care in general practice were randomly assigned to receive intensified care from the specialist team or further routine care. Even in such relatively persistent cases, benefits from intensified collaborative management were identified.
These studies involved additional resources above and beyond those routinely available in primary care. Wells et al44 investigated the dissemination of a quality improvement programme in which the additional costs of enhanced depression management were met by the practices themselves. Basing the programme upon the AHCPR guidelines, practice nursing staff were trained to become depression specialists, and to establish a case register of depressed patients within the practice. The nurses carried out regular review of medication. In a second intervention group of practices, enhanced access to cognitive-behavioural treatment was provided. Modest benefits in recovery rates were again demonstrated.
Taking a different approach, Simon et al investigated a telephone case management system operated by nurses45. At a relatively low cost (approximately £50 per patient), improvements in the number of patients receiving appropriate medication and in depression outcome were demonstrated. This finding was obtained without selecting only patients with major depression, although the proportion of patients included with milder forms of depression may still have been lower than is the case in UK general practice.
Confirming that such findings are not unique to the US, a further Southampton study demonstrated that minimal extra intervention by a nurse could enhance care. Two sessions with the patient of approximately 20 min focused upon the need for medication and appropriate utilization of medicines led to a significant improvement in adherence, and improved outcome in the subset of patients with major depression who were receiving prescriptions for adequate doses of treatment21. This approach is currently being tested further by application to primary care patients selected for the presence of major depression and adequate medication dosage in Ireland (Bradley, personal communication).
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Cost-effectiveness of treatment in primary care |
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It has been suggested that, in spite of their higher unit cost, newer antidepressants may be more cost-effective than older tricyclics, as they may be better tolerated, and therefore, more effective in preventing costly treatment failure30
. However, this has been the subject of considerable debate46–48. Meta-analyses of randomised trials comparing the two groups for their efficacy and discontinuation rates have found no overall difference in efficacy and only small absolute differences (around 3%) in drop-out rates, with more patients in the tricyclic groups citing side-effects as the reason for dropping out49–52. The advantage in drop-out rates for selective serotonin re-uptake inhibitors (SSRIs) holds only against the older, more toxic compounds (amitriptyline and imipramine) and not the newer tricyclics (dothiepin, nortriptyline, and clomipramine) or the ‘heterocyclics’ (mianserin, trazodone, desipramine and maprotiline)53.
In these clinical trial populations, this advantage does not seem to be clinically important – the number needed to treat with SSRIs to prevent one drop-out is more than 3053,54. However, evidence from these trials may not be directly applicable to clinical practice in primary care, as trial populations are often selected for narrowly defined levels of severity of depression and the absence of co-morbid conditions, such as alcohol use, which might make the SSRIs a more attractive option. A study of the ratio of discontinuations to inceptions of treatment in routine general practice found an 11% difference (22% versus 33%) in favour of the SSRIs, and the reported perceptions of the GPs studied suggested that tolerability rather than lack of efficacy explained most of this difference55. Similarly Thompson et al56 were able to show a 15% advantage in compliance for fluoxetine when compared with dothiepin in a primary care population.
As their patents expire, the SSRIs will become cheaper, although not nearly as cheap as the old tricyclics; therefore, this will not end the debate over cost-effectiveness. A cost-effectiveness comparison of imipramine, desipramine, and fluoxetine in a primary care population in Seattle, USA, funded by Lilly Research Laboratories (the makers of fluoxetine), found no significant differences in total healthcare costs over 6 months, with higher antidepressant costs in the fluoxetine group balanced by lower out-patient and in-patient costs57. However, it has been pointed out that these findings may not generalise to the UK given the very different patterns of health-care utilisation58. We are currently carrying out a study of the relative cost-effectiveness of TCAs, SSRIs, and lofepramine in a more representative sample of UK general practice patients (the AHEAD study).
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Implications for future practice and organization of depression management in primary care |
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As the primary care research agenda has begun to be pursued, a number of messages now seem to be becoming clearer. The first and probably most important discovery is that primary care differs from secondary care in a number of important ways, and it is unwise to extrapolate research evidence beyond the limits of its applicability. The content of guidelines may have to change as new evidence is accumulated, for example about the efficacy of medication in patients with significant social difficulties or milder forms of depression, and about the most effective forms of brief psychological treatment. The threshold at which drug treatment becomes more effective than placebo needs definition as soon as possible, and this information can only be derived from a large pragmatic treatment trial in primary care.
Secondly the extent to which depression should be seen as a chronic disease rather than as an episodic acute illness needs further consideration. The management of chronic diseases is often more effectively organised through the provision of special clinic sessions outside routine surgeries, usually staffed by practice nurses. Such ‘mini-clinics’ have been shown to improve the outcome of asthma59 and diabetes60, and are now widespread in UK general practice, encouraged by the provision of special chronic disease management payments. Special clinic sessions usually feature systematic assessment of symptoms, treatment effects, and side-effects; protocols for modifying management; and pro-active follow-up, with outreach to non-attenders. It is becoming clear that some aspects of the management of depression lend themselves well to this approach.
There is good evidence that, as well as improving adherence to drug treatment21, practice nurses can be trained to deliver effective structured psychological treatments such as problem-solving in primary care61. The US models of intensified case management suggest further research designs for UK teams to adopt, and the development of primary care groups and trusts in England and Wales creates an opportunity to develop sub-specialisation at primary care level, similar to that possible within US-style Health Maintenance Organizations.
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Key points for clinical practice |
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- The prevalence of depressive illness and the nature of mental health service provision dictate that the large majority of patients with depression are managed in primary care
- By comparison with standards derived from secondary care, primary care management often appears to be sub-optimal, but generalising research findings from secondary to primary care settings may not be justified
- Guidelines and education alone are of limited effectiveness in improving primary care management
- Provision of enhanced care supported by additional resource has been shown to be of benefit, involving either placing or developing more specialised workers in primary care
- The benefits of psychological treatments of proven effectiveness are constrained by limited availability in most healthcare systems, while resources are being spent on other treatments of unproven effectiveness, such as non-directive counselling
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Footnotes |
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Correspondence to: Prof R Peveler,University Department of Psychiatry, Royal South Hants Hospital, Brintons Terrace, Southampton SO14 0YG, UK
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