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Treating of Major Depression in Primary Care Practices: A Critique of Guidelines
Physicians are trained to follow guidelines and best practices. The guidelines they are reading for treating major depression are seriously flawed and we need to challenge the guidelines. The original guidelines were written in1993. The update appeared in an article in the December 1998 Archives of General Psychiatry, vol. 55, pp. 1121-1127. The full text can be downloaded from: http://www.ama-assn.org/sci-pubs/journals/archive/psyc/vol_55/no_12/yps8016.htm. I encourage you to download and read the article for content and to examine the reviewers’ objectivity. At the conclusion of the first paragraph the authors write with great understatement that the guidelines’ potential to improve patient outcomes and reduce practice variation was not totally fulfilled. They then take a conservative and politically correct position that unless there is overwhelming evidence they do not challenge the adequacy of the guidelines issued in 1993. They close the article with seven unanswered questions which are worthy of attention to practitioner and researcher alike. I am personally grateful for the effort and acumen which they put into this presentation of the data available to them at the time. I do not agree with some of their conclusions. Some of the data and conclusions are the ones I would use to argue for prescriptive authority for psychologists. This is why I am calling it to your attention. They examined over 200 articles and selected for review randomized controlled trials in primary care settings published between 1992 and 1998. They conclude in part “This evidence indicates that both antidepressant pharmacotherapy and time-limited depression targeted psychotherapies are efficacious when transferred from psychiatric to primary care settings. In most cases, the choice between these treatments should depend on patient preference. Studies to date suggest that improving treatment of depression in primary care requires properly organized treatment programs, regular follow-up, monitoring of treatment adherence, and a prominent role for the mental health specialist as educator, consultant and clinician for the more severely ill. Future research should focus on how guidelines are best implemented in routine practice, since conventional dissemination strategies have little impact.” (This is a potent argument for prescription privileges.) The first question addressed is “Does The Efficacy Of Antidepressant Pharmacotherapy Transfer From Specialty To Primary Care Practice?” The percentage of patients whose improved 50% on the Hamilton Rating Scale or whose Clinical Global Improvement score indicated marked or extensive improvement were the criteria. Efficacy rate were 64% for tricyclics, 65% for heterocyclics and 54% for SSRIs. Efficacy rates for random trial in psychiatric setting were 52%, 62% and 47% respectively. They cite Lin’s report of a 37% relapse rate within one year. The authors cite data from other studies and “conclude, therefore, that antidepressant medications prescribed for acute and continuation-phase treatment of depressed primary care patients are associated with a response rate of 50%-60%, which approximates that found for psychiatric patients.” Another question taken out of order of presentation for sake of comparison was “Does The Efficacy Of Depression-Specific Psychotherapies Transfer From Specialty To Primary Care Practice?” They note that no primary care studies of psychosocial interventions for major depression met the AHCPR Panel’s rigorous methodical standards. (This was one of my criticisms of the 1993 guidelines.) Thus, the Panel’s estimates of 46% efficacy for cognitive therapy, 55% for behavioral therapy, and 52% for interpersonal therapy (IPT) were derived from psychiatric studies. Three new studies are reported from primary care settings with response rates of 60% to 72% . “We conclude, therefore that the efficacy of psychosocial treatments as a monotherapy for major depression does transfer from specialist to generalist settings.” The reader will note the similarity of the outcome rates between monotherapy whether by means of pharmacotherapy or psychotherapy. The authors addressed, “Are Tricyclic Antidepressants Or Newer Antidepressants Preferable For First Line Pharmacotherapy?” Ten studies are cited with mixed results. Attrition rates (discontinuation of treatment) were used as the measure. Attrition rates were highest in HMOs when tricyclics and hetercyclics were use and the lowest for fee-for-service patients where SSRIs were prescribed. Costs of medication comparisons were made by five studies. The authors concluded that while costs were higher for SSRIs, total treatment costs per depressive episode are similar for patients treated with SSRI or TCA medications. The next asked question was “Do Weekly Or Biweekly Visits During Acute-Phase Pharmacotherapy Enhance Patient Outcomes?” AHCPR Panel guidelines recommended weekly or 10-14 day consultations for the first six to eight weeks of pharmacotherapy depending on the severity of the depression. No studies were found to address this question directly Katon et al. found that patients in a HMO were seen approximately monthly during acute phase pharmacotherapy and high rates of attrition and low rates of recovery. Schulberg found patients randomly assigned to weekly or biweekly visits had significantly better outcomes than patients provided with usual care. When prescribed antidepressant medication the usual care group averaged only four visits in eight months. This finding should be no surprise. Nevertheless it provides a powerful argument for psychologists being able to prescribe and manage patient care for depression in comparison to usual care by primary care physicians! “Is Pharmacotherapy or Depression-Specific Psychotherapy Preferable As A First-Line Treatment?” The AHCPR Panel recommended pharmacotherapy over psychotherapy for the severely depressed and less severely depressed were deemed to benefit from IPT, cognitive therapy, imipramine or even placebo with supportive management. Either medication or psychotherapy could serve as the initial treatment for patients with mild or moderate depression. Two randomized trials in primary care found comparable efficacy for pharmacotherapy and psychotherapy: 1. Mynors-Wallis found 52% for amitriptyline, 60% for problem-solving therapy and 27% for placebo, 2. Schulberg et al found 48% for nortriptyline and 46% for IPT. In a secondary analysis of baseline severity and treatment selection Schulberg data did not confirm better outcomes for the severely depressed with pharmacotherapy. Others reported presence or absence of endogenous symptoms did not affect the outcome of either antidepressant medication or cognitive therapy. Schulberg concluded psychotherapy and pharmacotherapy were equally efficacious. The authors found little new evidence of the relative efficacy of combined treatment in primary care settings. (Maybe because the rarity of the practice of the combined treatment in primary care.) Data for combined treatment comes from patients seen in psychiatric settings. There is some support for combined treatment there. They conclude, “The Panel’s recommendation, therefore, should continue as current practice based on face validity rather than empirical support.” (This position of empiricism is difficult for clinician to accept when on the treatment firing line of patient care. When to change the treatment protocol or modify a treatment regimen is discretionary is up to the judgment of the treating clinician according to my viewpoint.) “Which Patients Should Be Referred for Specialty Care? The guidelines list severe symptoms, suicide risk, comorbid medical, psychiatric, or substance abuse disorder; and failure to respond to treatment as reasons to refer for specialty care. “Katon et al demonstrated that collaboration between psychiatrists or psychologists and primary care physicians significantly improved clinical outcomes over the generalist’s usual care.” … “Thus, it remains unclear whether the commonsense AHCPR recommendations for specialty referral are clinically or economically justified.” “Can Guideline Principles Be Implemented In Primary Care?” The authors cite some studies where primary care physicians could be trained and supported in the treatment of depression with a structured protocol. Compared with usual primary care, these structured programs achieved improved acute-phase outcomes. The authors presented some trials for educational intervention of depression that did not benefit the patient Dowrick and Buchan showed providing primary care physicians the results of depression screening results had no significant impact. Callahan that an educational program followed by feedback of depression screening and treatment recommendations to primary care physicians did not increase the quality of pharmacotherapy or its clinical outcomes. Goldberg in randomized trial of implementing depression guidelines with primary care physicians found no significant impact on recognition of depression, appropriateness of pharmacotherapy, or clinical outcomes. Lin found that the improved patient outcomes by Katon et al in their collaborative care programs faded after the withdrawal of the mental health specialist and systematic monitoring of treatment. They conclude “Absent a structured follow-up system, didactic education of physicians, academic detailing, or even patient-specific treatment recommendations are insufficient to achieve practice changes.” (Thus, there is a place for psychologists in primary care and this provides a rationale why appropriately trained psychologists should be authorized to prescribe.) For practice guidelines to be implemented in practice patients must be willing to participate in the treatment. Schulberg found 55% of patients assigned to guideline-based group completed the acute-phase but only 33% completed both the acute and continuation phases. (This is a 30% attrition rate of the completers.) Randomized clinical trials in primary care of psychotherapy achieved completion rates of 93% for a six-session course in problem solving therapy, 88% for four sessions of a multifaceted intervention, 47% who attended a 12 session of interpersonal therapy and 42% who participated in the IPT acute and continuation-phase sessions. (In sum, IPT shows a net gain in completing a treatment regimen over pharmacotherapy. It is speculated that this is due to the personal attention and relationships developed with psychotherapy. It is difficult to understand how a practice guideline can replace the personal interest in psychotherapy. It can seen how this personal interest can be minimal or lost in following a practice guideline.) Finally, “Does The Implementation Of Treatment Guidelines Produce Cost-Effective Services?” The AHCPR Panel of 1993 did not address cost- effectiveness in treating depression. (This was a glaring omission in my judgment.) Von Korff found that additional expenditures of $250 to $450 in collaborative management of depressed patients increased the likelihood of treatment response from 40% to 70%. Lave et al analyzed guideline based pharmacotherapy and psychotherapy over a 12 month period and determined that either treatment produced significantly more depression free days than usual care by internists and family physicians. Pharmacotherapy resulted in 58 more depression free days at a cost of $13 per day and psychotherapy 49 days at cost of $22 per day. (Apparently relapse rates and costs were not factored in. Paykel et al. reported cognitive psychotherapy reduced relapse of depression from 47% in routine clinical management by psychiatrists to 29% (Arch. Gen. Psychiatry, Sept 99). Sturm and Wells’ analysis “How can care for depression become more cost-effective?” (JAMA 1995; 273:52-58) concluded, “Shifting patients away from mental health specialists decreases costs but worsens functioning outcomes. The best strategy for making care for depression treatment cost-effective is through quality improvement not through changing specialty mix.” (Non-medical therapists [psychologists] managing patients on antidepressant medications did as well as psychiatrists in reducing functioning limitations and were superior to primary care physicians.) Sturm and Wells data indicated the cost of removing a functioning limitation to be between $1,000 and $2,000 with a result of increased family income of $2,000 and $3,000 annually. Taxes on this added income would offset the added costs of treatment. The authors of this report include some of Sturm and Wells data and conclude,”… clinical and functional outcomes of depressed patients can be improved at a cost of $750 to $1500 per enhanced treatment episode. What they do not include is the data showing that primary care physicians treatment of depressed patients with antidepressant medication does not remove functioning limitations. Two-thirds of the improvement in functioning limitations was attributed to counseling and combining counseling with the use of antidepressants without the use of anti-anxiety medications resulted in a 50% improvement rate over counseling alone. In their “Comment” section the lead sentence is “Recent studies support the AHCPR Panel’s major conclusions.” The last sentence is “ Nevertheless, improved clinical practice also requires properly organized treatment programs, and a prominent role for the specialty clinician as educator, consultant, and primary provider for the more severely ill.” In all fairness to the authors, they have done excellent work in assembling and reporting the data within the narrow empiricism of proven treatments and outcomes. Again, let me urge you to read the article yourself and draw your own conclusions. My objections come not from the empirical work done but from the position of the practicing clinician seeking solutions to current treatment issues not responding to the guidelines or receiving direction from them. Slavish empiricism with its focus on the past stifles creativity and clinical progress. Yet, the backward focus of research can provide some assistance in avoiding pitfalls and can tell us what won’t work even if it cannot answer why what we are doing does work. My summation is that the attempt to turn treatment of depression over to primary care physicians using antidepressant medications has been less than a success. The potency of these newer antidepressant medications has not (and will not) overcome the lack of training in modern psychological treatments and procedures. The practice patterns used by primary care physicians to deal with public demands is not designed to deal with the unique requirements of patients with depression. The subtle stigma against mental conditions allows physicians in the trenches to subtly triage their efforts to those they can help within the tight time constraints they are allowed to see patients and earn a decent wage. I would probably do the same if I were wearing a white coat. Treatment of depression doesn’t fit in these parameters. What should psychology do if the treatment of depression in primary care has not been a great success and the incidence of depression is expected to increase so that it will be the second leading cause of disabling effects of illness and injury by the Year 2020? My answer is to prepare ourselves as a primary health care discipline to address the public needs through enhanced skills of, not only psychotherapy, but pharmacotherapy, as well. As rehabilitation experts we must deal with the disabling effects of non-fatal outcomes of illness and injury, 47% of which is attributed to psychological depression. Most psychologists practicing in health care already have a good knowledge base in psychotropic medications, including the routine introduction, monitoring and discontinuance of antidepressants. We now have ten psychologically grounded training programs in psychopharmacology to provide systematic training. We now have an APA sponsored national examination in psychopharmacology to assess the knowledge base of psychological practitioners. We have public acceptance of our skills in managing mental conditions with medications. As a primary health care profession we only lack legislative authority to provide psychological services augmented by the use of psychotropic medications. It is my judgment that it is now time to fulfill psychology’s role as a primary care discipline with prescriptive authority.
Jack Wiggins, Ph.D. is a past president of APA and has been very active in pursuing prescription privileges. This article was excerpted from the Weekly Reader (#65 September 29, 1999), which he writes. The Weekly Reader is an electronic newsletter distributed free by the Psychologists for the Advancement of Pharmacotherapy (PAP), a Section of Division 42. The listserv is apap@lists.apa.org . To subscribe to the Weekly Reader contact dr_wiggins@psychological.com. To review abstracts of the psychological aspects of physical disorders go to http://www.apa.org/divisions/div42/primepsych. PAP has filed a Petition for Division status in APA. |
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