Dropout rates

High dropout rates notwithstanding, those who stay in treatment have excellent results. Clients remaining for 90 days or more do better than dropouts on legitimate employment, number of arrests, self-reported drug use, and antisocial behavior these results hold true at 1- and 5-year follow-ups (Bale et al. 1984 DeLeon 1985). However, some research showed a negative correlation between duration of residence and outcome, particularly for clients with extensive psychiatric symptoms, who do comparatively poorly in therapeutic community settings (McLeUan 1986). 

With few exceptions, models find in favour of newer compounds Qonsson and Bebbington, 1994 Le Pen et al, 1994 McFarland, 1994 Stewart, 1994 Einarson et al, 1995 Lapierre et al, 1995 Nuitjen et al, 1995 Montgomeiy et al, 1996). One study (CCOHTA, 1997) did make allowances for variations in practice and patient behaviour. The results indicated that in the short term treatment was likely to be more successful with an SSRI than with a TCA, but at a higher cost. However, when treatment dropout rates found in naturalistic studies were substituted for drop-out rates found in controlled trials, the cost differences became smaller. When cost-utility analysis was applied, this increased cost was offset by improvements in quality of life for the patients. 

A prospective, randomized, placebo-controlled trial of paroxetine in adults with chronic post-traumatic stress disorder (PTSD) was recently conducted (Marshall etal., 2007). The subjects were New Yorkers, predominantly female (67%) and Hispanic (65.4%). Seventy subjects entered the study and after a one week placebo lead-in, 52 subjects were randomized to placebo or paroxetine for ten weeks. The subjects were treated with a flexible dosage design (mean dosage, 40.4 mg/day). Dropout rates were 32% for paroxetine and 51.9% for placebo. There were no differences in rates of adverse effects between treatment arms. Paroxetine was superior to placebo in ameliorating the primary symptoms of PTSD (56% vs. 22.2%). 

This corresponds to similar dropout rates across the treatment groups. The answer to the question is no It is the mix of patients that is the basis of a valid comparison, not the numbers of patients. It is almost inevitable that if... 

What are the implications of the trial procedures on the potential dropout rate and the extent of missing data ... 

That SSRIs are more acceptable from the patient s perspective than traditional TCAs is largely accepted by clinicians but has recently been questioned in an article by F. Song et al. [1993]. These researchers conducted a metaanalysis of 63 randomized controlled trials comparing the efficacy and acceptability of SSRIs with those of tricyclic and related antidepressants. The article has been cited widely, especially in the United Kingdom. The authors suggest that the dropout rate in patients receiving SSRIs is similar to that of patients receiving TCAs in controlled studies. They concluded that the routine use of SSRIs as the first-line treatment of depressive illness was not... 

TABLE 7-27. Dropout rates (%) as a function of dose in fixed-dose, placebo-controlled studies... 

Braden et al. (95) did a similar study in primarily schizophrenic or schizoaffective patients, but the sample also included some affectively-ill cases (i.e., 21% met Feighner criteria for mood disorder). Of the 43 patients on lithium, 15 dropped out because they did not improve, worsened, or were unmanageable or confused. By comparison, only one of 35 treated with CPZ dropped out in the first 10 days. CPZ produced better results in the overactive group, whereas both drugs were comparable in the less active group. As with the VA study, the poor results with lithium in the overactive group may have been an artifact of insufficient duration due to the high dropout rate, or because of the inclusion of patients with a core schizophrenic illness. 

Finally, only the lithium group had a significantly higher dropout rate due to adverse effects in comparison with those in the placebo group. 

The long-term efficacy and safety of finasteride have been studied in 102 patients with benign prostatic hyperplasia (62). Adverse experiences due to sexual dysfunction continued throughout the study, but the low continuous dropout rate may have reflected a natural process in this aged population, and not necessarily a drug-related effect. 

Specific immunotherapy using subcutaneous injections (SCIT) has been used for almost 100 years. It is clearly helpful for allergic rhinitis from pollens. Treatment of asthma, especially from molds, is not as clearly successful. Factors such as the inconvenience and expense of traveling for allergy shots contribute to a dropout rate greater than 50% over a multiyear course of... 

Inhalant abuse is found in both urban and mral areas of the United States and Canada. Research indicates social and economic rather than racial and cultural factors in general impact the rate of inhalant abuse. Poverty, physical or mental abuse as a child, poor grades in school, and dropping out of school are all associated with increased inhalant abuse. At particularly high risk are Native American youths who live on reservations where poverty and school dropout rates are high. 

One of the worst aspects of heavy marijuana use may be what researchers call the amotivational syndrome that robs people of their ambition, drive, and energy. A 2000 study showed that teenagers who use marijuana drop out of high school at more than twice the rate of nonusers those who also abuse other drugs have even higher dropout rates. 

Substance abuse in general is a far-reaching societal problem, impacting personal relationships and health as well as crime, domestic violence, sexual assault, dropout rates, unemployment, and homelessness. It is also a factor in public health problems such as unwanted pregnancy, HIV/AIDS transmission, and the spread of sexually transmitted diseases (STDs). 

Through FOIA, I have had the opportunity to review the Zoloft Summary Basis of Approval (1988). Many of the problems that plagued the NDA of Prozac were also rampant in the NDA for Zoloft, including numerous violations of protocol, the use of concomitant long-acting benzodiazepines, high dropout rates, many negative studies, and no evidence of efficacy in hospitalized patients. In fact, the efficacy of Zoloft was considered questionable until the last minute before its final approval (discussed in chapter 13). 

Two basic procedures seem called for compare the dropout rates and time-to-dropout across all treatment groups, and analyze the intent-to-treat group (all randomized patients). Beyond this, consider two analyses (in addition to intent-to-treat) to assess the impact of the dropouts on the final results an end point analysis (the last clinical and laboratory observations of each patient) and an analysis of all patients actually evaluated at each of the scheduled patient visits. 

In a 9-week double-blind, randomized, placebo-con-trolled study, subjects were assigned to either risperidone (n = 14, 13 men and 1 woman mean age 42 years dose titrated upwards up to 2 mg/day) or to placebo (n = 9, 6 men and 3 women mean age 39 years) (43). Adverse effects were reported in seven subjects who took risperidone, including dry mouth, tiredness, weakness, reduced sexual arousal and delayed ejaculation, and a mild dys-tonic reaction. However, five placebo-treated subjects also reported adverse effects, which might have been due to the strong tendency of these patients to become somatically preoccupied. There were no group differences in dropout rates due to adverse effects. 

In two studies of rivastigmine, 38% of users suffered from nausea, 23% from vomiting, and 24% from vertigo (8). Over 6 months there was a dropout rate of 25%. The gastrointestinal effects led to significant loss of weight. The positive response rate was only 10%, compared with a 6% response to placebo. 

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