In my last 2 columns, I discussed the problems associated with clinical practice guidelines and described how some physicians use them in practice. In this column, I will review studies on the validation of clinical algorithms, which are 1 of the 2 main types of practice guidelines. Algorithms are detailed, step-by-step flow charts that outline the recommended treatment for patients with a specific disorder.1
Initial studies—such as the stepped collaborative care intervention, Texas Medication Algorithm Project (TMAP), and German Algorithm Project (GAP) phase 2—predominantly investigated whether following an expert opinion–based clinical algorithm (irrespective of the content of the algorithm) led to a better outcome than treatment as usual did.2-4 Subsequent studies, including the Sequenced Treatment Alter na tives to Relieve Depression (STAR*D) and GAP phase 3, focused on comparing the effectiveness of different treatments that were provided at each step in a sequenced algorithm.5,6 The former studies tell us something about the process of care, or how treatment should be provided. The latter tell us about the content of care, or which treatment should be provided at each stage in the algorithm.
Clinical algorithm studies
Several studies suggest that patients with a major depressive or bipolar disorder who are treated according to an accepted clinical algorithm (ALGO) have more successful outcomes than those treated as usual (TAU).6 Some of these studies, and their results, are discussed below.
Stepped collaborative care study
Katon and colleagues3,7 studied the effect of a stepped collaborative care intervention for primary care patients who had persistent or treatment-resistant depression that did not respond to several weeks of conventional antidepressant treatment. Patients were divided into 2 groups: an ALGO group, treated using a "stepped-care" algorithm that included education and structured clinical interventions, and a TAU group, who were simply told to speak with their primary care physician about treatment for depression. Depression was measured using the 20-question depression subscale of the Hopkins Symptom Checklist-90. Patients in the ALGO group who had moderately severe depression—but not those who had severe depression—were significantly improved compared with patients in the TAU group (P = .004) after several months of treatment.
In the GAP, Adli and colleagues8 developed a standardized stepwise drug treatment regimen (SSTR) for treatment-resistant depression. In a randomized controlled study, they used the Bech-Rafaelsen Melancholia Scale (BRMS) to compare the outcome of patients treated by SSTR (n = 74) and TAU (n = 74).4 SSTR-treated patients had a better outcome than TAU patients (BRMS scores: SSTR = 5.4, TAU = 9.5; P < .01). The SSTR group also had a significantly higher dropout rate (45%) than the TAU group (16%). The authors commented that 33% of the dropouts were due to physician non compliance with algorithm rules.