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[Efficacy and efficiency of antitubercular treatment in health jurisdictions of Morelos].

OBJECTIVE: To evaluate the efficacy and efficiency of tuberculosis treatment administered by the Secretaría de Salud (SSA) in the sanitary jurisdictions of Cuernavaca and Cuautla, Morelos, for the 1992-1996 period by retrospectively reviewing tuberculosis treatment control cards. MATERIAL AND METHODS: Official Norm for Tuberculosis Prevention and Control in Primary Care Units outcome definitions were used. Data was collected on standardized forms and analyzed with SAS and Epi Info programs; 149 primary care units and 4 hospitals in the study area were visited. RESULTS: There were found 288 patients cards, of which 260 were new cases. These patients received 311 treatments of which 85% were directly observed. Reviewed cards represented 60% of SSA notified cases for this period. There were analyzed 246 treatments of which 32% were bacteriological cures, 26% probable cures, 18% dropouts, 1% failures and 3% deaths. In 20% of treatments the outcome was unknown. Cure rate was better in new cases (61%) than in retreatments (38%), p < 0.01. Efficacy of treatment was 71% and efficiency 58%. Patients receiving retreatment abandoned it more frequently (32%) than new cases (16%), p < 0.01. A statistically significant association was found between abandoned treatment and being retreated (OR = 3.3, CI 95% 1.3-8.5, p = 0.01) or belonging to a lower socioeconomic level (OR = 2.3, CI 95% 1.0-4.9, p = 0.04). In the 34 retreatment programs, 22 were initiated after abandonment, failure or relapse. CONCLUSIONS: Proportion of cure rate (58%) compares unfavorably with WHO recommendations (85%). Implications of a high dropout rate and probability of circulation of resistant strains of M tuberculosis are discussed. Creative strategies to reinforce patient compliance which take into account the patient and not only the health services, extension of cultures to known M. tuberculosis drug resistance and evaluation of modifications to drug regimens are proposed. Review of treatment control cards is a useful tool for program evaluation.

Adult↗

Comparative evaluation of two methods of natural family planning in Columbia.

Results of a comparative study of the ovulation method (OM) and symptothermal method (STM) of natural family planning in Colombia are presented. Recruitment of volunteer couples began in August, 1976, and continued through December, 1978, during which time 566 couples were randomly assigned to one or the other of the two methods. The study included 3 to 5 months of training in the method assigned, after which the couples entered the follow-up phase of the study. They remained in follow-up until (1) they dropped out or (2) the study closed in June, 1979. Total dropout rates were high for both methods of natural family planning. One year after entry into the follow-up phase of the study, net pregnancy rates were 24.2% for OM users and 19.8% for STM users. Gross pregnancy rates were 29.2% for OM and 26.1% for STM. Differences in pregnancy rates between the two methods were not statistically significant.

Adolescent↗

Effectiveness of low-dose methadone maintenance for the treatment of inner city heroin addicts.

Addicts were maintained on a daily average methadone dose of 30 mg. Clients remaining in treatment for 6 and 12 months were compared to clients dropping out of treatment within the first 30 days and followed up 1 year later. Results showed that clients remaining in treatment showed signficant reductions in heroin usage and arrests, and large increases in full-time employment. One year later, the dropouts were doing as poorly as they had 1 year earlier. Methadone maintenance averaging 30 mg/day achieved similar "success' rates as other studies using larger daily doses, but did so at the expense of retaining fewer clients in treatment. It was recommended that treatment strategies be designed to impact at the first 30 days of treatment to retain them in treatment in view of the beneficial effects awaiting them if they stay.

Crime↗

Hypertension continuation adherence: natural history and role as an indicator condition.

We analyzed a random sample of general medicine clinic patients to determine the natural history of newly treated hypertensive (NH) patients: discontinuation patterns, critical intervention periods, and hypertension's (HBP) utility as an indicator condition. The NH patients exhibited a 48% dropout rate in the first year and better continuation adherence than new nonhypertensive (NNH) patients. Patients with HBP and other chronic diseases had better continuation adherence than those with HBP alone, although no predictive patterns emerged. New patients displayed rapid early discontinuation, with further linear decline by four months for NNH and by eight months for NH patients. All patients showed similar subsequent falloff: linear annual decline at 13% to 36%. We conclude that discontinuation rates are unacceptably high, that interventions must be continued throughout treatment, and that HBP has limited utility as an indicator chronic disease.

Adult↗

Withdrawal from methadone maintenance. Rate of withdrawal and expectation.

One hundred twenty-seven successfully methadone-hydrochloride-maintained patients were randomly assigned to one of the following four groups and studied for 30 weeks: (1) known maintenance-patients were maintained on methadone under open conditions; (2) blind maintenance-patients were maintained on methadone under double blind conditions; (3) rapid withdrawal-patients were withdrawn under double-blind conditions at a rate of 10% of initial dose per week; (4) gradual withdrawal-patients were withdrawn under double-blind conditions at a rate of 3% of initial dose per week. Differences in dropout rates, illicit drug use, symptoms scores, and requests for study interruption indicate that withdrawal from methadone maintenance should be carried out at approximately 3% of initial dose per week. Better patient preparation also is indicated to reduce the effects of expectation.

Adult↗

Pretraining for group psychotherapy. A cognitive-experiential approach.

Pretherapy training for group psychotherapy is conceptualized in terms of learned conditions of preparedness (objectives) and in terms of methods of preparation (procedures). Controlled studies of pretraining for group psychotherapy were reviewed in reference to these two dimensions and their effects. A controlled study of pretraining involving five outpatient therapy groups that used a new cognitive-experiential approach to pretraining was performed. Pretrained groups had significantly higher patient attendance and significantly fewer dropouts than nonpretrained groups.

Adult↗

Focusing on dreams. A preparation program for psychotherapy.

Forty-eight patients selected as potential early dropouts from insight-oriented psychotherapy were offered a two-week program to prepare them for treatment. Thirty-two were sleep-monitored for eight nights; half were given access to their dreams by awakening them from rapid eye movement (REM) sleep periods; the other half were awakened as often, but only from non-FEM (NREM) stages. A third group of 16 subjects went directly into treatment. All laboratory subjects were asked each morning to recall and discuss the reports they had given during the night. The effect of these discussions was measured on the drop-out rate during the first ten treatment hours and on the development of treatment-appropriate behaviors. Those who successfully retrieved and discussed dreams as opposed to other content stayed in therapy at a significantly higher rate and used the hours more productively.

Adolescent↗

Long-term treatment of anxiety and risk of withdrawal. Prospective comparison of clorazepate and buspirone.

Risk of withdrawal was investigated in a prospective, double-blind comparison of clorazepate dipotassium, a benzodiazepine with a long half-life, and the nonbenzodiazepine buspirone hydrochloride in the long-term treatment of anxious outpatients. Patients were treated with therapeutic doses of clorazepate dipotassium (15 to 60 mg/d) or buspirone hydrochloride (10 to 40 mg/d) for six continuous months before their tranquilizer therapy was blindly and abruptly stopped. There was a significant increase in symptom severity consistent with a withdrawal reaction for the clorazepate group but not the buspirone group. For the clorazepate group, there was a suggestion that previous discontinuous exposure to benzodiazepines might sensitize patients to subsequent withdrawal effects. For the buspirone group, a higher dropout rate raised questions about patient satisfaction with therapy in this rather chronically anxious population.

Adult↗

A double-blind comparison of clomipramine and desipramine treatment of severe onychophagia (nail biting).

Twenty-five adult subjects with severe morbid onychophagia (nail biting) and no history of obsessive-compulsive disorder were enrolled in a 10-week double-blind cross-over trial of clomipramine hydrochloride and desipramine hydrochloride. For the 14 subjects who completed the study, clomipramine hydrochloride (mean +/- SD dose, 120 +/- 48 mg/d) was superior to desipramine hydrochloride (mean +/- SD dose, 135 +/- 53 mg/d) in decreasing nail biting as measured by a repeated-measures analysis of variance on the Nail Biting Severity, Nailbiting Impairment, and Clinical Progress scales. The high dropout rate at every stage of the study was in sharp contrast to that seen with psychiatric populations. From a neuroethologic perspective, similar biologic systems are hypothesized to mediate a spectrum of grooming behaviors, including onychophagia, trichotillomania, and obsessive-compulsive disorder.

Adult↗

Desipramine treatment of cocaine dependence in methadone-maintained patients.

We performed a double-blind, placebo-controlled, randomized 12-week trial of desipramine hydrochloride treatment of cocaine dependence among methadone-maintained patients. Fifty-nine patients completed the 12-week medication trial (36 received desipramine and 23 received placebo), and 94% were recontacted 1, 3, and 6 months after treatment. There were significantly more dropouts in the desipramine than in the placebo group. Baseline to 12-week comparisons of Addiction Severity Index interview data indicated that both groups showed improvements. At 12 weeks, the desipramine group showed significantly better psychiatric status than the placebo group but did not differ from the placebo group on any of 21 other outcome measures, including cocaine use. During the 12-week medication phase and at the 1-month follow-up evaluation, urine toxicology screenings showed no significant difference between groups, but the placebo group had significantly less cocaine use at both the 3- and 6-month follow-up points. We conclude that desipramine has few benefits with regard to control of cocaine use in this population.

Adult↗

Induction with levomethadyl acetate: safety and efficacy.

BACKGROUND: Levomethadyl acetate hydrochloride (known as LAAM) is a mu-opioid agonist approved for the treatment of opioid dependence. Clinical trials comparing LAAM and methadone have reported lower patient retention rates during LAAM induction; however, this may reflect dose and schedule differences. Few studies have systematically examined LAAM dose induction. This study compared induction with 3 different LAAM dosage levels. METHODS: In a randomized, double-blind trial, male and female opioid-dependent patients (N = 180) were assigned to 1 of 3 LAAM doses. The low-dose (25 mg) induction was constant from the onset of treatment, the medium-dose (50 mg) induction lasted 7 days, and the high-dose (100 mg) induction lasted 17 days. Safety and efficacy were assessed on retention, urinalysis and self-reported drug use, symptoms, and patient ratings of medication adequacy. RESULTS: The high-dose group had significantly fewer illicit opioid-positive urine samples in weeks 3 and 4 as compared with the low-dose group. The high-dose group had significantly lower self-reported heroin craving in weeks 2 and 3. All groups demonstrated significant decreases in illicit drug use, withdrawal symptoms, and depression. There were no between-group differences in retention; however, there was a trend (P = .08) for lower retention and a greater number of agonist adverse effects were observed in the high-dose group. Overall, LAAM doses were well tolerated by most patients. CONCLUSION: Induction with low and medium LAAM doses can be safely and effectively achieved within 7 days. Induction with higher LAAM doses can be safely achieved within 17 days, but may result in greater rates of patient dropout and opioid agonist adverse effects. Therefore, higher doses should be approached more slowly.

Adult↗

Randomized trial of trauma-focused group therapy for posttraumatic stress disorder: results from a department of veterans affairs cooperative study.

BACKGROUND: Department of Veterans Affairs Cooperative Study 420 is a randomized clinical trial of 2 methods of group psychotherapy for treating posttraumatic stress disorder (PTSD) in male Vietnam veterans. METHODS: Vietnam veterans (360 men) were randomly assigned to receive trauma-focused group psychotherapy or a present-centered comparison treatment that avoided trauma focus. Treatment was provided weekly to groups of 6 members for 30 weeks, followed by 5 monthly booster sessions. Severity of PTSD was the primary outcome. Additional measures were other psychiatric symptoms, functional status, quality of life, physical health, and service utilization. Follow-up assessments were conducted at the end of treatment (7 months) and at the end of the booster sessions (12 months); 325 individuals participated in 1 or both assessments. Additional follow-up for PTSD severity was performed in a subset of participants at 18 and 24 months. RESULTS: Although posttreatment assessments of PTSD severity and other measures were significantly improved from baseline, intention-to-treat analyses found no overall differences between therapy groups on any outcome. Analyses of data from participants who received an adequate dose of treatment suggested that trauma-focused group therapy reduced avoidance and numbing and, possibly, PTSD symptoms. Dropout from treatment was higher in trauma-focused group treatment. Average improvement was modest in both treatments, although approximately 40% of participants showed clinically significant change. CONCLUSIONS: This study did not find a treatment effect for trauma-focused group therapy. The difference between the effectiveness and adequate dose findings suggests the possible value of methods to enhance the delivery of cognitive-behavioral treatments in clinical practice settings.

Ambulatory Care↗

Threats to validity in randomized clinical trials.

The purposes of this article are to present an overview of randomized clinical trials (RCTs) and describe some of the methodological problems inherent in using RCTs in nursing research. Many nursing intervention studies are fraught with problems that defy the stringent control criteria required for RCTs, leading to biased estimates of intervention efficacy. Five threats to validity in RCTs are presented, including problems related to (a) differential dropout, (b) random assignment, (c) identifying and maintaining an adequate control condition, (d) nonadherence to research protocols, and (e) assessment of clinically meaningful change. Three strategies are recommended for addressing some of the problems posed by RCTs and improving inference.

Clinical Nursing Research↗

Defense mechanisms and personality in depression.

There is a longstanding belief that personality represents a structure that is stable over time, and changes, if at all, very slowly. Nonetheless, clinical and empirical evidence suggests that in patients with some Axis I disorders, the rate of personality disorders using DSM criteria decreases after treatment, suggesting that personality as assessed by phenomenological systems is state-dependent. An alternative to the DSM phenomenological system of conceptualizing personality is the dynamic concept of character, that is, a predictable pattern of both adaptive and pathological defense mechanisms, and personality organization comprised of object relations, ego strengths, and superego development. Data from this study address the hypothesis that defense mechanisms and personality organization remain relatively stable in patients treated for Axis I disorders, irrespective of clinical improvement. Patients meeting DSM-IV criteria for major depressive disorder (MDD) entered randomized, controlled medication trials. Defensive functioning was evaluated with the Defense Style Questionnaire (DSQ) [Bond et al., 1983: Arch Gen Psychiatry 40:333-338], and personality organization was assessed with the Inventory of Personality Organization (IPO; Clarkin et al., unpublished), both at baseline and at the completion of the clinical trial. Data were analyzed for whether an individual's pattern of defense mechanisms and personality organization were stable over time regardless of response to treatment of MDD. The question was also asked whether a predominant pattern of defense mechanisms or level of personality organization predicts response to treatment or dropout rate. Among treatment responders, nonresponders and drop-outs, baseline DSQ scores were similar except for "image-distorting" defenses, which were significantly more prevalent among drop-outs compared to responders (P = .016). Post-treatment DSQ values revealed a significant decrease in "maladaptive" defenses (P = .01) in the entire sample, while intermediate and "adaptive" defenses remained unchanged. This same pattern was found to hold true in treatment responders. When comparing treatment responders and nonresponders at the end of the trial, medication responders used significantly less "maladaptive" defenses than did nonresponders (P = .003), and had a significantly higher, or healthier level of "overall defensive functioning" (P = .04). Baseline and post-treatment IPO values did not show significant differences. Results of the study address the question of whether there are personality characteristics that are enduring and that can be appreciated irrespective of an Axis I disorder.

Adult↗

Sexual functioning in depressed outpatients taking mirtazapine.

OBJECTIVES: One-third of patients with untreated depression have sexual difficulties manifested by decreased libido, erectile dysfunction or delayed ejaculation. This dysfunction may be exacerbated by stimulation of post-synaptic serotonin 5HT2 receptors, a side-effect of most widely-used antidepressant medications, especially the selective serotonin reuptake inhibitors (SSRIs). Mirtazapine is an atypical antidepressant with alpha 2 adrenergic antagonist and serotonin 5-HT2 and 5-HT3 receptor-blocking activity. In theory, it should not worsen and perhaps may improve sexual function. This pilot study investigated sexual functioning and antidepressant activity in depressed patients taking mirtazapine. EXPERIMENTAL DESIGN: Twenty-five (F = 18, M = 7) sexually active adult outpatients with a DSM-IV-diagnosis of major depressive episode entered a 12-week, flexible-dosing, open-label pilot study. The Arizona Sexual Experiences Scale (ASEX) assessed sexual functioning and the Hamilton Depression Rating Scale (HAM-D) assessed depressive symptoms on a bimonthly basis. PRINCIPAL OBSERVATIONS: Desire, arousal/lubrication, and ease/satisfaction of orgasm improved (by 41%, 52%, and 48%, respectively) in the depressed women. In men, desire, arousal/erection, and ease/satisfaction of orgasm also improved (by 10%, 23% and 14%, respectively) but much more modestly. HAM-D, Clinical Global Impression (CGI) Sheehan Disability Scale (SDS), and Symptom Checklist-90 (SCL-90) scores improved in both groups. There was a 50% dropout rate among women before six weeks of treatment. However, the ASEX and HAM-D scores of the groups terminating before and after six weeks of treatment showed similar rates of improvement. CONCLUSIONS: Mirtazapine has a beneficial effect on sexual functioning in both depressed women and men. Longer-term double-blind research assessing sexual function during the administration of mirtazapine as well as other antidepressants is recommended.

Adult↗

Relationship of clients' reasons for dropping out of treatment to outcome and satisfaction.

Forty-nine adult drop-outs and parents of 37 child drop-outs were contacted 4 months after intake and asked why they terminated treatment. Outcome and satisfaction data also were obtained for these clients, 45 treatment completers, and 51 who were still in treatment. Problem improvement, environmental obstacles, and dissatisfaction with treatment were the reasons most often cited for dropping out. For adults, client measures indicated that "problem improved" drop-outs had superior outcome and satisfaction and that "dissatisfied" drop-outs had inferior outcome and satisfaction relative to other drop-out groups. For children, "dissatisfied" and "environmental obstacle" drop-outs had inferior outcome and satisfaction. Therapist ratings did not differ among dropout groups and were lower than those of completers and continuers.

Adjustment Disorders↗

Clinical trial of penicillamine in rheumatoid arthritis.

The medical records of our first 200 consecutive rheumatoid arthritis patients treated with penicillamine were analyzed retrospectively. All but 5 patients (97.5%) had undergone earlier chrysotherapy that resulted in either therapeutic failure or toxicity. Only 57 patients (28.5%) were still receiving penicillamine on January 1, 1981, and the duration of therapy ranged from 23 to 62 months. The dropout rate due to toxicity, therapeutic failure, relapse, or other reasons was very high (71.5%). Toxic effects required permanent discontinuance in 56 patients (28%). Therapy was discontinued for 36 patients (18%) because of no benefit. A striking number (20) had relapse after therapeutic success and while continuing to take penicillamine, and the therapy had to be discontinued, a relapse rate of 10%. Therapy for the remaining 15.5% was discontinued for miscellaneous reasons that were not related to penicillamine per se: patient anxiety (6%), lost to followup (5%), hospitalization for reasons unrelated to penicillamine therapy (2%), lack of cooperation and study protocol (1% each), or pregnancy (0.5%). By our criteria, 142 patients (71%) received benefit (remission or improvement). Therapy results for these patients were as follows: still on penicillamine on January 1, 1981 (28.5%); no longer receiving the drug due to toxicity (19.5%); no longer receiving penicillamine due to relapse while on continuing therapy (10%); no longer receiving penicillamine due to miscellaneous reasons not related to penicillamine therapy (13%). This study shows that penicillamine is a valuable drug in the treatment of rheumatoid arthritis, but its value in clinical practice is limited by a rather high incidence of both toxicity and relapse during treatment.

Adult↗

Effectiveness of coronary heart disease risk management in high-risk patients.

The purpose of this study was to investigate the efficacy of the patient-based coronary heart disease (CHD) risk management strategy in general practice by analyzing patients who were sent to a specialized center as refractory to conventional treatment. Of the 452 patients studied, 152 were excluded because of secondary hyperlipidemia. The effects of a food protocol-monitored dietary/drug treatment on lipid profiles and CHD risk indices and the compliance to this approach were monitored for 12 months in 300 of 452 patients. CHD risk classification was performed according to NIH criteria by the referring physicians, but secondary hyperlipidemia was not identified and treated appropriately. Physicians did not fully utilize dietary and drug treatment and referred the patients to a specialized center too early. The initiated food protocol-controlled treatment was more efficient than pretreatment in general practice, with a compliance of 80.3% by patients selected according to their CHD risk. Long-term CHD risk reduction was persistent for 12 months in compliant patients; however, a cumulative dropout rate of 43% after 6 months and of 68% after 12 months was noted. Statistical analysis failed to reveal consistent prognostic factors of long-term compliance.

Apolipoproteins A↗