Safety and tolerability of sauna detoxification for the protracted withdrawal symptoms of substance abuse.

OBJECTIVE: Protracted drug withdrawal symptoms can last months or years after drug cessation, often precipitating a return to substance misuse. We evaluated the safety and preliminary health benefits of a unique chemical exposure regimen based on exercise, sauna and therapeutic nutrients. METHODS: This was a prospective evaluation of 109 individuals sequentially enrolled into a sauna detoxification component of a multi-modal, long-term residential substance abuse treatment centre. RESULTS: Data from medical charts, client self-reports and Short Form Health Survey (SF-36) responses indicated that the Hubbard sauna detoxification method was well tolerated, with a 99% completion rate, including one human immunodeficiency virus and nine hepatitis C positive clients. There were no cases of dehydration, overhydration or heat illness. Statistically significant improvements were seen in both mental and physical SF-36 scores at regimen completion, as well as in Addiction Severity Index and Global Appraisal of Individual Needs Short Screener change scores at rehabilitation program discharge, compared with enrolment. CONCLUSIONS: The regimen lacked serious adverse events, had a very low discontinuation rate and high client-reported satisfaction. The SF-36 data indicated improved physical and emotional symptoms. Therefore, broader investigation of this sauna-based treatment regimen is warranted.

A simplified method for routine outcome monitoring after drug abuse treatment.

THE ROUTINE COLLECTION OF DRUG TREATMENT OUTCOMES TO MANAGE QUALITY OF CARE, IMPROVE PATIENT SATISFACTION, AND ALLOCATE TREATMENT RESOURCES IS CURRENTLY HAMPERED BY TWO KEY DIFFICULTIES: (1) problems locating clients once they leave treatment; and (2) the prohibitive cost of obtaining meaningful and reliable post-treatment data. This pilot describes precise methods for an economical staff-based routine outcome monitoring (ROM) system using an 18-item core measure telephone survey. As implemented at Narconon™ of Oklahoma, a behavioral and social skills based, residential drug rehabilitation program, the system was psychometrically adequate for aggregate reporting while providing clinically useful information. Standardized procedures for staff training, collecting client contact information, structuring exit interviews and maintaining post-treatment telephone contact produced follow-up rates that improved from 57.6% to 100% over the course of the project. Aggregate data was used to improve program delivery and thereby post-treatment substance use and social outcomes. These methods and use of data may contribute to the discussion on how to best monitor outcomes.

Comparison of the Addiction Severity Index (ASI) and the Global Appraisal of Individual Needs (GAIN) in predicting the effectiveness of drug treatment programs for pregnant and postpartum women.

This study conducts a within-subject comparison of the Addiction Severity Index (ASI) and the Global Appraisal of Individual Needs (GAIN) to assess change in alcohol and other drug treatment outcomes for pregnant and postpartum women. Data are from 139 women who were pregnant or who had children under 11 months old and were admitted to residential drug treatment, then re-interviewed 6 months postdischarge (83% follow-up rate). The ASI and GAIN change measures were compared on their ability to detect changes in alcohol and drug use, medical and HIV risk issues, employment issues, legal problems, family and recovery environment characteristics, and psychological/emotional issues. The measures were similar in their ability to detect treatment outcomes, and ASI and GAIN change scores were moderately correlated with each other. The GAIN scales had equal or slightly higher coefficient alpha values than the ASI composite scores. The GAIN also includes an HIV risk scale, which is particularly important for pregnant and postpartum women. These results suggest that the GAIN is comparable with the ASI and can be used for treatment research with pregnant and postpartum women.

Practical application of the vanishing tetrad test for causal indicator measurement models: an example from health-related quality of life.

Researchers are often faced with the task of trying to measure abstract concepts. The most common approach is to use multiple indicators that reflect an underlying latent variable. However, this 'effect indicator' measurement model is not always appropriate; sometimes the indicators instead cause the construct of interest. While the notion of 'causal indicators' has been known for some time, it is still too often ignored. However, there are limited means to determine whether a possible indicator should be treated as a cause or an effect of the latent construct of interest. Perhaps the best empirical way is to use the vanishing tetrad test (VTT), yet this method is still often overlooked. We speculate that one reason for this is the lack of published examples of its use in practice, written for an audience without extensive statistical training. The goal of this paper was to help fill this gap in the literature-to provide a basic example of how to use the VTT. We illustrated the VTT by looking at multiple items from a health related quality of life instrument that seem more likely to cause the latent variable rather than the other way around.

Remission, response without remission, and nonresponse in major depressive disorder: impact on functioning.

Major depressive disorder (MDD) is associated with significant functional impairment. This post-hoc analysis of data from two randomized trials assessed the impact of response status on functioning in MDD. Patients with at least one historical treatment failure followed by an inadequate response after 8 weeks of prospective open-label treatment with escitalopram, fluoxetine, paroxetine-CR, sertraline, or venlafaxine-XR plus single-blind placebo were randomized to 6 weeks of double-blind treatment with adjunctive placebo or adjunctive aripiprazole. At the end of double-blind treatment, patients were defined as: in remission [>or=50% reduction in Montgomery-Asberg Depression Rating Scale (MADRS) score with MADRS or=50% reduction in MADRS with MADRS >10); or with a nonresponse (all others). Functional status was assessed with the Sheehan Disability Scale. Of the 679 patients, 144 were in remission, 44 had a response without remission, and 491 had a nonresponse. Mean improvements in the Sheehan Disability Scale total and item scores were significantly greater in patients in remission versus those with a response without remission (P<0.02) as well as nonresponse (P<0.001). Structural Equation Modeling found that efficacy (Hamilton Rating Scale for Depression scores) did not significantly correlate with functioning in this study. In conclusion, MDD patients achieving symptomatic remission experience greater functional improvements than those respond without remission. Functioning may be a distinctly different outcome from symptom reduction. Treatments focused on producing high remission rates may improve patient functioning over and above that seen with patients who only achieve response.

The NARCONON drug education curriculum for high school students: a non-randomized, controlled prevention trial.

BACKGROUND: An estimated 13 million youths aged 12 to 17 become involved with alcohol, tobacco and other drugs annually. The number of 12- to 17-year olds abusing controlled prescription drugs increased an alarming 212 percent between 1992 and 2003. For many youths, substance abuse precedes academic and health problems including lower grades, higher truancy, drop out decisions, delayed or damaged physical, cognitive, and emotional development, or a variety of other costly consequences. For thirty years the Narconon program has worked with schools and community groups providing single educational modules aimed at supplementing existing classroom-based prevention activities. In 2004, Narconon International developed a multi-module, universal prevention curriculum for high school ages based on drug abuse etiology, program quality management data, prevention theory and best practices. We review the curriculum and its rationale and test its ability to change drug use behavior, perceptions of risk/benefits, and general knowledge. METHODS: After informed parental consent, approximately 1000 Oklahoma and Hawai'i high school students completed a modified Center for Substance Abuse Prevention (CSAP) Participant Outcome Measures for Discretionary Programs survey at three testing points: baseline, one month later, and six month follow-up. Schools assigned to experimental conditions scheduled the Narconon curriculum between the baseline and one-month follow-up test; schools in control conditions received drug education after the six-month follow-up. Student responses were analyzed controlling for baseline differences using analysis of covariance. RESULTS: At six month follow-up, youths who received the Narconon drug education curriculum showed reduced drug use compared with controls across all drug categories tested. The strongest effects were seen in all tobacco products and cigarette frequency followed by marijuana. There were also significant reductions measured for alcohol and amphetamines. The program also produced changes in knowledge, attitudes and perception of risk. CONCLUSION: The eight-module Narconon curriculum has thorough grounding in substance abuse etiology and prevention theory. Incorporating several historically successful prevention strategies this curriculum reduced drug use among youths.

Extending basic principles of measurement models to the design and validation of Patient Reported Outcomes.

A recently published article by the Scientific Advisory Committee of the Medical Outcomes Trust presents guidelines for selecting and evaluating health status and health-related quality of life measures used in health outcomes research. In their article, they propose a number of validation and performance criteria with which to evaluate such self-report measures. We provide an alternate, yet complementary, perspective by extending the types of measurement models which are available to the instrument designer. During psychometric development or selection of a Patient Reported Outcome measure it is necessary to determine which, of the five types of measurement models, the measure is based on; 1) a Multiple Effect Indicator model, 2) a Multiple Cause Indicator model, 3) a Single Item Effect Indicator model, 4) a Single Item Cause Indicator model, or 5) a Mixed Multiple Indicator model. Specification of the measurement model has a major influence on decisions about item and scale design, the appropriate application of statistical validation methods, and the suitability of the resulting measure for a particular use in clinical and population-based outcomes research activities.

Minimal important difference (MID) of the Dermatology Life Quality Index (DLQI): results from patients with chronic idiopathic urticaria.

BACKGROUND: The Dermatology Quality Life Index (DLQI) has seen widespread use as a health-related quality of life measure for a variety of dermatological diseases. The purpose of this study was to estimate the minimal important difference (MID) on the DLQI for patients with chronic idiopathic urticaria (CIU). METHODS: Data from 2 Phase III clinical trials of patients (N = 476 for Study A; N = 468 for Study B) with CIU were analyzed separately to estimate the MID for the DLQI for these populations. Both distributional based and anchor based approaches were used for deriving estimates. The anchor based approach relied upon patient self assessments of pruritus severity; the distributional based approaches relied upon estimating the standard error of measurement, as well as one-half the standard deviation of the DLQI from each study. RESULTS: The distributional approaches resulted in estimates of MID ranging from 2.24 to 3.10 for the two studies. The anchor based approach resulted in estimates of 3.21 and 2.97 for the two studies. CONCLUSION: An MID for the DLQI in the range of 2.24 to 3.10 is recommended in interpreting results for patients with CIU.

Psychometric validation of a patient-reported sensory perception and preference instrument: the Sensory Perceptions Questionnaire.

This study evaluated the psychometric properties of content validity, construct validity, and test-retest reliability of a 23-item Sensory Perceptions Questionnaire (SPQ) used to survey sensory perceptions of intranasal corticosteroid sprays. Two patient cohorts (men and women aged > or =18 years who had at least a 1-year history of allergic rhinitis and had been using a corticosteroid nasal spray) were enrolled. The content validity and construct validity of the SPQ questions were evaluated using a cognitive debriefing method after cohort 1 (n=15) completed the SPQ. Test-retest reliability (assessed with intraclass correlation coefficients [ICCs] of the SPQ questions) was evaluated in cohort 2 (n=50), after they answered a Web-based version of the SPQ on two occasions, each separated by 7 days. In cohort 1, 7 of 15 patients believed all relevant sensory perceptions were addressed in the questionnaire. Although 8 patients mentioned at least 1 sensory perception that was not addressed, only 4 sensory perceptions were mentioned by more than 1 patient, and none was mentioned reliably by more than 2 patients. Those 4 sensory perceptions not addressed in the SPQ were all intentionally excluded, because they were potential symptoms of rhinitis or adverse events associated with intranasal corticosteroid spray use. Patients regarded the questions as straightforward, nonburdensome, and nonthreatening, signs suggesting the questions were not likely to challenge the construct validity of the SPQ. The responses to 2 questions (one in which patients were asked to indicate whether they were pleased or displeased overall with a particular spray; the other to indicate their overall product preference) were somewhat influenced by the effectiveness of the sprays. Results of test-retest reliability (cohort 2) showed both high (>0.8) and low (<0.7) ICCs. A high degree of correspondence between the 2 administrations produced a low between-patient variance, which likely resulted in lower ICCs. The SPQ adequately represents the sensory attributes reported by patients regarding intranasal corticosteroid spray use and, overall, is a valid measure of patient preference based on sensory perception.

Validation of the Dermatology Life Quality Index as an outcome measure for urticaria-related quality of life.

BACKGROUND: Chronic idiopathic urticaria (CIU) is a debilitating skin disease that affects patients' quality of life (QOL). The Dermatology Life Quality Index (DLQI) assesses QOL parameters across several types of dermatologic conditions. However, an evaluation of the validity of the DLQI for use in CIU patients has not been undertaken, because CIU, unlike other chronic skin conditions, is subject to daily or weekly symptom fluctuations. OBJECTIVE: To test the reliability and validity of the DLQI in 2 samples of CIU patients treated with fexofenadine hydrochloride (20, 60, 120, or 240 mg twice daily). METHODS: Data were obtained from 2 similar multicenter, double-blind, randomized, placebo-controlled, parallel-group studies of CIU patients (n = 418 and n = 439). Patients completed the 10-item DLQI during 3 clinic visits (approximately 2 weeks apart). Clinic personnel also recorded patients' symptoms. RESULTS: The results of the DLQI items were similar to those obtained with other skin disease populations, indicating the presence of relatively symmetrical distributions. Reliability was high, demonstrating the lack of excessive random measurement error (alpha coefficient = .89 and .87 for samples 1 and 2). Factor analysis resulted in a unidimensional pattern, supporting the use of a total DLQI score. Most DLQI items distinguished patients with varying degrees of QOL impairment, highlighting the sensitivity of this instrument. Construct validity was moderate, providing evidence that the DLQI was responsive to changes in patients' clinical status. CONCLUSIONS: The DLQI is a valid, reliable, and clinically useful outcome measure for assessing QOL in CIU patients.