Compliance Enhancement Research Articles

5-HTTLPR moderates naltrexone and psychosocial treatment responses in heavy drinking men who have sex with men.

A functional polymorphism (5-HTTLPR) in the promoter region of the serotonin transporter gene has been widely studied as a risk factor and moderator of treatment for a variety of psychopathologic conditions. To evaluate whether 5-HTTLPR moderates the effects of treatment to reduce heavy drinking, we studied 112 high-functioning European-American men who have sex with men (MSM). Subjects participated in a randomized clinical trial of naltrexone (NTX) and cognitive behavioral therapy (CBT) for problem drinking. Subjects were treated for 12 weeks with 100 mg/d of oral NTX or placebo (PBO). All participants received medical management with adjusted brief behavioral compliance enhancement treatment (BBCET) alone or in combination with modified behavioral self-control therapy (MBSCT; an amalgam of motivational interviewing and CBT). Participants were genotyped for the tri-allelic 5-HTTLPR polymorphism (i.e., low-activity S' or high-activity L' alleles). During treatment, the number of weekly heavy drinking days (HDD; defined as 5 or more standard drinks per day) was significantly lower in subjects with the L'L' (N = 26, p = 0.015) or L'S' (N = 52, p = 0.016) genotype than those with the S'S' (N = 34) genotype regardless of treatment type. There was a significant interaction of genotype with treatment: For subjects with the S'S' genotype, the effects of MBSCT or NTX on HDD were significantly greater than the minimal intervention (i.e., BBCET or PBO, p = 0.007 and p = 0.049, respectively). In contrast, for subjects with 1 or 2 L' alleles, the effects of the more intensive psychosocial treatment (MBSCT) or NTX did not significantly differ from BBCET or PBO. These preliminary findings support the utility of the 5-HTTLPR polymorphism for personalizing treatment selection in problem drinkers.

Effectiveness of alcohol treatment interventions integrated into routine tuberculosis care in Tomsk, Russia

To test the feasibility and effectiveness of brief counseling intervention (BCI) and naltrexone integrated into tuberculosis (TB) care in Tomsk, Russia. Using a factorial randomized controlled trial design, patients were randomized into: naltrexone (NTX), brief behavioral compliance enhancement therapy (BBCET), treatment as usual (TAU) and BCI. In the Tomsk Oblast, hospitalized TB patients diagnosed with alcohol use disorders (AUDs) by the DSM-IV were referred at the start of TB treatment. Of the 196 participants, the mean age was 41 years and 82% were male. Severe TB (84.7% had cavitary disease) and smoking (92.9%) were common. The majority had a diagnosis of an AUD (63.0%); 27.6% reported nearly daily drinking and consumed a median of 16 standard drinks per day. Primary outcomes were 'favorable' TB outcome (cured, completed treatment) and change in mean number of abstinent days in the last month of study compared with baseline. Change in mean number of heavy drinking days, defined as four drinks per day and five drinks per day for women and men, respectively, and TB adherence, measured as percentage of doses taken as prescribed under direct observation, were secondary outcomes. Analysis based on 'intention-to-treat' was performed for multivariable analysis. Primary TB and alcohol end-points between naltrexone and no-naltrexone or BCI and no-BCI groups did not differ significantly. TB treatment adherence and change in number of heavy drinking days also did not differ significantly among treatment arms. Among individuals with a prior quitting attempt (n = 111), naltrexone use was associated with an increased likelihood of favorable TB outcomes (92.3% versus 75.9%, P = 0.02). In Tomsk Oblast, Russia, tuberculosis patients with severe alcohol use disorders who were not seeking alcohol treatment did not respond to naltrexone or behavioral counselling integrated into tuberculosis care; however, those patients with past attempts to quit drinking had improved tuberculosis outcomes.

Enhancing Homework Compliance in Correctional Psychotherapy

This study investigated the effects of three homework compliance enhancement strategies (task option, task modeling, and public commitment) on a sample of probationers’ compliance with therapeutic homework tasks during the course of a multiphasic correctional treatment program. The study featured a within-subjects, counterbalanced, experimental design. Homework compliance was measured on the basis of therapists’ record of probationers’ homework completion (i.e., “yes/no” tally), as well as probationers’ scores on the Homework Rating Scale–II Client and Therapist rater versions. Results were mixed but suggested that public commitment and task modeling are potentially useful strategies in enhancing probationers’ beliefs about, expectations of, and compliance with therapeutic homework tasks. Furthermore, results provided preliminary support for the reliability of the Homework Rating Scale–II within correctional populations. Implications for correctional service delivery, treatment programming, and treatment outcome are discussed, as is the need for further research in this area.

Variation in Mu-Opioid Receptor Gene (OPRM1) as a Moderator of Naltrexone Treatment to Reduce Heavy Drinking in a High Functioning Cohort.

It is well known that naltrexone, an FDA-approved medication for treatment of alcohol dependence, is effective for only a subset of individuals. Recent studies have examined the utility of a functional A118G single nucleotide polymorphism (SNP) of the mu-opioid receptor gene (OPRM1) as a predictor of naltrexone treatment response. Although the findings to date have generally been consistent with a moderating effect of the SNP, further evaluation of this hypothesis is warranted. To evaluate whether problem drinkers with one or two copies of the 118G allele respond better to naltrexone treatment. The treatment goal in this cohort of high functioning men who have sex with men (MSM) was to reduce heavy drinking, rather than to promote abstinence. 112 subjects of European ancestry from a randomized clinical trial of naltrexone and behavioral therapy for problem drinking MSM were included in the analysis. Subjects were treated for 12 weeks with 100 mg/day of oral naltrexone hydrochloride. All participants received medical management with a modified version of the Brief Behavioral Compliance Enhancement Treatment (BBCET), alone or in combination with Modified Behavioral Self-control Therapy (MBSCT). Naltrexone-treated subjects with one or two 118G alleles had a significantly greater percentage of non-hazardous drinking (NoH) (p < 0.01) than those treated with placebo or A118 homozygotes in either medication group. These results are consistent with a modest moderating effect of the OPRM1 118G allele on the reduction of heavy drinking by naltrexone treatment.

Topiramate for the treatment of methamphetamine addiction: a multi‐center placebo‐controlled trial

Topiramate has shown efficacy at facilitating abstinence from alcohol and cocaine abuse. This double-blind, placebo-controlled out-patient trial tested topiramate for treating methamphetamine addiction. Participants (n = 140) were randomized to receive topiramate or placebo (13 weeks) in escalating doses from 25 mg/day [DOSAGE ERROR CORRECTED] to the target maintenance of 200 mg/day in weeks 6-12 (tapered in week 13). Medication was combined with weekly brief behavioral compliance enhancement treatment. The trial was conducted at eight medical centers in the United States. One hundred and forty methamphetamine-dependent adults took part in the trial. The primary outcome was abstinence from methamphetamine during weeks 6-12. Secondary outcomes included use reduction versus baseline, as well as psychosocial variables. In the intent-to-treat analysis, topiramate did not increase abstinence from methamphetamine during weeks 6-12. For secondary outcomes, topiramate reduced weekly median urine methamphetamine levels and observer-rated severity of dependence scores significantly. Subjects with negative urine before randomization (n = 26) had significantly greater abstinence on topiramate versus placebo during study weeks 6-12. Topiramate was safe and well tolerated. Topiramate does not appear to promote abstinence in methamphetamine users but can reduce the amount taken and reduce relapse rates in those who are already abstinent.

A Double‐Blind, Placebo‐Controlled Trial Assessing the Efficacy of Levetiracetam Extended‐Release in Very Heavy Drinking Alcohol‐Dependent Patients

Despite advances in the development of medications to treat alcohol dependence, few medications have been approved by the U.S. Food and Drug Administration. The use of certain anticonvulsant medications has demonstrated potential efficacy in treating alcohol dependence. Previous research suggests that the anticonvulsant levetiracetam may be beneficial in an alcohol-dependent population of very heavy drinkers. In this double-blind, randomized, placebo-controlled clinical trial, 130 alcohol-dependent patients who reported very heavy drinking were recruited across 5 clinical sites. Patients received either levetiracetam extended-release (XR) or placebo and a Brief Behavioral Compliance Enhancement Treatment intervention. Levetiracetam XR was titrated during the first 4 weeks to 2,000 mg/d. This target dose was maintained during weeks 5 through 14 and was tapered during weeks 15 and 16. No significant differences were detected between the levetiracetam XR and placebo groups in either the primary outcomes (percent heavy drinking days and percent subjects with no heavy drinking days) or in other secondary drinking outcomes. Treatment groups did not differ on a number of nondrinking outcomes, including depression, anxiety, mood, and quality of life. The only difference observed was in alcohol-related consequences. The levetiracetam XR treatment group showed significantly fewer consequences than did the placebo group during the maintenance period (p = 0.02). Levetiracetam XR was well tolerated, with fatigue being the only significantly elevated adverse event, compared with placebo (53% vs. 24%, respectively; p = 0.001). This multisite clinical trial showed no efficacy for levetiracetam XR compared with placebo in reducing alcohol consumption in heavy drinking alcohol-dependent patients.

Compliance, capacity, and quality in colonoscopy screening for CRC: A novel solution.

357 Background: CRC is predominately preventable with high quality colonoscopy screenings. Unfortunately, less than half of Americans are “up-to-date.” When referred by primary care providers, less than half complete the process. We proposed to include the primary care provider (PCP) in a novel training program to extend skills from sigmoidoscopy to full colonoscopy in a “mentored and monitored” model. We know that quality in colonoscopy can vary widely (ten fold within a single 12-man group). The protective benefits of colonoscopy reflect the thoroughness of the removal of polyps. Unfortunately, the ACS projections for 2010 predict an increase of 4,400 deaths from CRC over 2009, an 8% rise! Furthermore the death rate for African American men has RISEN 28% since 1960. We are loosing a battle for which we posses the tools to win. To achieve victory we must successfully address all three factors: compliance, capacity and quality. Methods: Thirty primary care physicians in two states (SC, FL) were recruited. We measured compliance rates within the practice before and after enrollment. We further evaluated quality of the colonoscopies as reflected in completion, yield and complications. Results: Compliance more than doubled (38% to 84%). As a compliance enhancement tool, the results were outstanding. The evaluation of quality then became of paramount importance. The gross completion rate was 98.3%, the adenoma detection rate (reflecting polyp yield) was 38%. In over 20,000 cases there were only 5 perforations, substantially below published rates. The quality was consistently at the level of experienced conscientious gastroenterologists. The details of the training program and the use of the “two-man” colonoscopy technique have been reviewed elsewhere (MEDICAL CARE, Aug 2010). Conclusions: If replicated nationally, this model has the potential for saving 25,000 lives annually. The participation of the patient's PCP is a powerful influence for improved compliance. The availability of an “expert” for mentoring and monitoring results in outstanding and consistent quality. The model has the potential to dramatically enhance compliance simultaneously increasing capacity while maintaining outstanding quality. No significant financial relationships to disclose.

Long-Term Oxygen Therapy in COPD: Factors Affecting and Ways of Improving Patient Compliance

Long-term oxygen therapy (LTOT) is the cornerstone mode of treatment in patients with severe chronic obstructive pulmonary disease (COPD) associated with resting hypoxaemia. When appropriately prescribed and correctly used, LTOT has clearly been shown to improve survival in hypoxemic COPD patients. Adherence to LTOT ranges from 45% to 70% and utilization for more than 15 hours per day is widely accepted as efficacious. Although several studies have addressed the level of patients' adherence to LTOT, few have suggested or evaluated interventions that conduce to compliance enhancement. The lack of sufficient data regarding COPD patients following oxygen prescription is an enormous void that must be duly confronted to augment clinical effectiveness and cost containment for the long term use. The present review article highlights factors influencing the compliance of patients using LTOT and emphasizes novel strategies and interventions that may prove to be of significant benefit given the remarkably little current research appraising this issue. Therefore, additional research should be promptly performed to verify the efficacy of newly designed approaches in improving the outcomes of patients receiving LTOT.

A field experiment to explore the effects of detection and penalties communications and framing among Washington State retail firms

Abstract The Washington Department of Revenue facilitated a field experiment to explore opportunities to increase Use Tax and Business and Occupation (BO thus we tested two very different taxes. The results of the experiment suggest that revenue agencies with limited resources may benefit from focusing greater compliance enhancement efforts on firms with declining revenues as more tax dollars will be generated from these taxpayers. For tax researchers, this experiment demonstrates that gain/loss tax framing can occur in nature by means other than withholding.

Integrated Management of Physician-delivered Alcohol Care for Tuberculosis Patients: Design and Implementation.

While the integration of alcohol screening, treatment, and referral in primary care and other medical settings in the U.S. and worldwide has been recognized as a key health care priority, it is not routinely done. In spite of the high co-occurrence and excess mortality associated with alcohol use disorders (AUDs) among individuals with tuberculosis (TB), there are no studies evaluating effectiveness of integrating alcohol care into routine treatment for this disorder. We designed and implemented a randomized controlled trial (RCT) to determine the effectiveness of integrating pharmacotherapy and behavioral treatments for AUDs into routine medical care for TB in the Tomsk Oblast Tuberculosis Service (TOTBS) in Tomsk, Russia. Eligible patients are diagnosed with alcohol abuse or dependence, are newly diagnosed with TB, and initiating treatment in the TOTBS with Directly Observed Therapy-Short Course (DOTS) for TB. Utilizing a factorial design, the Integrated Management of Physician-delivered Alcohol Care for Tuberculosis Patients (IMPACT) study randomizes eligible patients who sign informed consent into 1 of 4 study arms: (1) Oral Naltrexone + Brief Behavioral Compliance Enhancement Therapy (BBCET) + treatment as usual (TAU), (2) Brief Counseling Intervention (BCI) + TAU, (3) Naltrexone + BBCET + BCI + TAU, or (4) TAU alone. Utilizing an iterative, collaborative approach, a multi-disciplinary U.S. and Russian team has implemented a model of alcohol management that is culturally appropriate to the patient and TB physician community in Russia. Implementation to date has achieved the integration of routine alcohol screening into TB care in Tomsk; an ethnographic assessment of knowledge, attitudes, and practices of AUD management among TB physicians in Tomsk; translation and cultural adaptation of the BCI to Russia and the TB setting; and training and certification of TB physicians to deliver oral naltrexone and brief counseling interventions for alcohol abuse and dependence as part of routine TB care. The study is successfully enrolling eligible subjects in the RCT to evaluate the relationship of integrating effective pharmacotherapy and brief behavioral intervention on TB and alcohol outcomes, as well as reduction in HIV risk behaviors. The IMPACT study utilizes an innovative approach to adapt 2 effective therapies for treatment of alcohol use disorders to the TB clinical services setting in the Tomsk Oblast, Siberia, Russia, and to train TB physicians to deliver state of the art alcohol pharmacotherapy and behavioral treatments as an integrated part of routine TB care. The proposed treatment strategy could be applied elsewhere in Russia and in other settings where TB control is jeopardized by AUDs. If demonstrated to be effective, this model of integrating alcohol interventions into routine TB care has the potential for expanded applicability to other chronic co-occurring infectious and other medical conditions seen in medical care settings.

Clinical pharmacy services and solid organ transplantation: a literature review

Organ transplantation represents the therapy of choice for most types of end-stage organ failure, and post-transplant patient care warrants great attention. The aim of this study was to summarise the available evidence regarding the role and impact of clinical pharmacy services in the care of solid organ transplant patients. A search of the literature was conducted using the MEDLINE, EMBASE and IPA databases to identify studies relevant to our investigation of the impact of clinical pharmacists' interventions. Only five out of nineteen of the included studies were randomised controlled trials; eleven studies were descriptive, and three were before-after studies. Interventions performed in these studies consisted of routine clinical pharmacy services with a focus on identifying, resolving and preventing drug-related problems; clinical pharmacy services with a focus on therapeutic drug monitoring; and those with a focus on compliance enhancement and educational interventions. The number and type of interventions and the physicians' acceptance rates were assessed in the majority of the included studies. Acceptance rates were generally above 95%, and most studies reported that clinical pharmacy services had a positive impact on the care of solid organ transplant patients. Positive perceptions of patients and health care professionals are also reported. In two of the studies, patients' compliance rates and drug knowledge were assessed following counselling by a pharmacist. Dosing-related interventions were the most common interventions proposed. Immunosuppressants, cardiovascular drugs and antimicrobials were the drug classes most affected by the clinical pharmacists' interventions. High quality evidence that supports the benefit of clinical pharmacy services in the care of solid organ transplant patients is rare. Nevertheless, all of the included studies showed that clinical pharmacy services had a positive impact. Furthermore, all included studies showed that patients and physicians appreciated clinical pharmacists. The various outcome measures used in these studies were improved by interactions with clinical pharmacists. More randomised controlled trials are needed to contribute to the paucity of the existing evidence.

Intermittent Marijuana Use Is Associated with Improved Retention in Naltrexone Treatment for Opiate‐Dependence

Naltrexone is a theoretically promising alternative to agonist substitution treatment for opioid dependence, but its effectiveness has been severely limited by poor adherence. This study examined, in an independent sample, a previously observed association between moderate cannabis use and improved retention in naltrexone treatment. Opioid dependent patients (N = 63), admitted for inpatient detoxification and induction onto oral naltrexone, and randomized into a six-month trial of intensive behavioral therapy (Behavioral Naltrexone Therapy) versus a control behavioral therapy (Compliance Enhancement), were classified into three levels of cannabis use during treatment based on biweekly urine toxicology: abstinent (0% cannabis positive urine samples); intermittent use (1% to 79% cannabis positive samples); and consistent use (80% or greater cannabis positive samples). Intermittent cannabis users showed superior retention in naltrexone treatment (median days retained = 133; mean = 112.8, SE = 17.5), compared to abstinent (median = 35; mean = 47.3, SE = 9.2) or consistent users (median = 35; mean = 68.3, SE = 14.1) (log rank = 12.2, df = 2, p = .002). The effect remained significant in a Cox model after adjustment for baseline level of heroin use and during treatment level of cocaine use. Intermittent cannabis use was also associated with greater adherence to naltrexone pill-taking. Treatment interacted with cannabis use level, such that intensive behavioral therapy appeared to moderate the adverse prognosis in the consistent cannabis use group. The association between moderate cannabis use and improved retention on naltrexone treatment was replicated. Experimental studies are needed to directly test the hypothesis that cannabinoid agonists exert a beneficial pharmacological effect on naltrexone maintenance and to understand the mechanism.

Effect of asthma compliance enhancement training on asthma control in patients on combination therapy with salmeterol/fluticasone propionate: a randomised controlled trial

We investigated if a higher proportion of adults with previously uncontrolled asthma can achieve total control when given salmeterol/fluticasone propionate (50/250 microg) bid and compliance enhancement training (CET) compared to those given medication alone. Open comparison of stable, but uncontrolled, adult asthmatics. After a 12-week treatment period on salmeterol/fluticasone propionate (period 1), patients who failed to achieve control were randomised to continuing treatment with or without CET for 12 weeks (period 2). The primary end point was the proportion achieving total control of their asthma in 7 of the last 8 consecutive weeks of period 2. A total of 361 subjects (50.4% males, mean age 40.0 +/- 14.4 years) in 29 centres were included, of whom 75.9% were randomised into treatment period 2 (n = 140 in the intervention group). The proportion of subjects achieving total asthma control was 8.8% and 7.6%, respectively, in the intervention and control group [not significant (NS)]. Mean morning peak flow, forced expiratory volume in one second (FEV(1)), asthma symptom score and quality of life improved significantly over the study period in both treatment groups. Furthermore, proportion of days with use of rescue medication declined from 59.7% +/- 34.6% (55.7% +/- 35.3%) during screening to 20.3% +/- 29.2% (19.4% +/- 30.9%) during treatment period 2 (NS). CET failed to increase the likelihood of achieving total control in asthmatics on salmeterol/fluticasone propionate compared to subjects receiving medication only. However, both groups had a significant improvement in asthma control. (Clinical Trials.gov number, NCT00351143)

Course of Late-Life Depression With Alcoholism Following Combination Therapy

The comorbidity of alcoholism and depression increases the complexity of treatment and is associated with severe disability and morbidity. However, long-term treatment algorithms have been understudied. This study examined the natural course of 74 depressed alcoholics over 6 to 12 months following a 12-week acute-phase trial of sertraline (Zoloft), naltrexone (Revia), and compliance enhancement therapy. Subjects were monitored for long-term outcomes based on their acute-phase trial response. Fifty-four subjects followed up at 6 months, and 50 subjects remained at the 12-month visit. Full responders at the end of the 12-week acute-phase trial sustained better overall outcomes (6 months: chi2=19.9, 4 df, p=.001; 12 months: chi2=11.7, 4 df, p=.020) and better drinking and depression outcomes, as compared with partial responders and nonresponders over a 6-month and 12-month period. Initial full responders sustain better overall treatment outcomes at 6 and 12 months, compared with partial responders and nonresponders. The defined outcome categories incorporate meaningful and practical measures of severity and can help predict treatment outcomes in clinical practice, thereby allowing timely interventions. Future studies should focus on maintenance strategies for full responders and treatment adaptations for partial responders and nonresponders.

Betting on change: Modeling transitional probabilities to guide therapy development for opioid dependence.

This study investigated the process of change by modeling transitions among four clinical states encountered in 64 detoxified opiate-dependent individuals treated with daily oral naltrexone: no opiate use, blocked opiate use (i.e., opiate use while adhering to oral naltrexone), unblocked opiate use (i.e., opiate use after having discontinued oral naltrexone), and treatment dropout. The effects of baseline characteristics and two psychosocial interventions of differing intensity, behavioral naltrexone therapy (BNT) and compliance enhancement (CE), on these transitions were studied. Participants using greater quantities of opiates were more likely than other participants to be retained in BNT relative to CE. Markov modeling indicated a transition from abstinence to treatment dropout was approximately 3.56 times greater among participants in CE relative to participants in BNT, indicating the more comprehensive psychosocial intervention kept participants engaged in treatment longer. Transitions to stopping treatment were more likely to occur after unblocked opiate use in both treatments. Continued opiate use while being blocked accounted for a relatively low proportion of transitions to abstinence and may have more deleterious effects later in a treatment episode. (PsycINFO Database Record (c) 2009 APA, all rights reserved).

Impact of enhanced compliance initiatives on the efficacy of rosuvastatin in reducing low density lipoprotein cholesterol levels in patients with primary hypercholesterolaemia.

The effectiveness of lipid-lowering medication critically depends on the patients' compliance and the efficacy of the prescribed drug. The primary objective of this multicentre study was to compare the efficacy of rosuvastatin with or without access to compliance initiatives, in bringing patients to the Joint European Task Force's (1998) recommended low-density lipoprotein cholesterol (LDL-C) level goal (LDL-C, <3.0 mmol/L) at week 24. Secondary objectives were comparison of the number and percentage of patients achieving European goals (1998, 2003) for LDL-C and other lipid parameters. Patients with primary hypercholesterolaemia and a 10-year coronary heart disease risk of >20% received open label rosuvastatin treatment for 24 weeks with or without access to compliance enhancement tools. The initial daily dosage of 10 mg could be doubled at week 12. Compliance tools included: a) a starter pack for subjects containing a videotape, an educational leaflet, a passport/goal diary and details of the helpline and/or website; b) regular personalised letters to provide message reinforcement; c) a toll-free helpline and a website. The majority of patients (67%) achieved the 1998 European goal for LDL-C at week 24. 31% required an increase in dosage of rosuvastatin to 20 mg at week 12. Compliance enhancement tools did not increase the number of patients achieving either the 1998 or the 2003 European target for plasma lipids. Rosuvastatin was well tolerated during this study. The safety profile was comparable with other drugs of the same class. 63 patients in the 10 mg group and 58 in the 10 mg Plus group discontinued treatment. The main reasons for discontinuation were adverse events (39 patients in the 10 mg group; 35 patients in the 10 mg Plus group) and loss to follow-up (13 patients in the 10 mg group; 9 patients in the 10 mg Plus group). The two most frequently reported adverse events were myalgia (34 patients, 3% respectively) and back pain (23 patients, 2% respectively). The overall rate of temporary or permanent study discontinuation due to adverse events was 9% (n = 101) in patients receiving 10 mg rosuvastatin and 3% (n = 9) in patients titrated up to 20 mg rosuvastatin. Rosuvastatin was effective in lowering LDL-C values in patients with hypercholesterolaemia to the 1998 European target at week 24. However, compliance enhancement tools did not increase the number of patients achieving any European targets for plasma lipids.

Impact of enhanced compliance initiatives on the efficacy of rosuvastatin in reducing low density lipoprotein cholesterol levels in patients with primary hypercholesterolaemia.

The effectiveness of lipid-lowering medication critically depends on the patients' compliance and the efficacy of the prescribed drug. The primary objective of this multicentre study was to compare the efficacy of rosuvastatin with or without access to compliance initiatives, in bringing patients to the Joint European Task Force's (1998) recommended low-density lipoprotein cholesterol (LDL-C) level goal (LDL-C, <3.0 mmol/L) at week 24. Secondary objectives were comparison of the number and percentage of patients achieving European goals (1998, 2003) for LDL-C and other lipid parameters. Patients with primary hypercholesterolaemia and a 10-year coronary heart disease risk of >20% received open label rosuvastatin treatment for 24 weeks with or without access to compliance enhancement tools. The initial daily dosage of 10 mg could be doubled at week 12. Compliance tools included: a) a starter pack for subjects containing a videotape, an educational leaflet, a passport/goal diary and details of the helpline and/or website; b) regular personalised letters to provide message reinforcement; c) a toll-free helpline and a website. The majority of patients (67%) achieved the 1998 European goal for LDL-C at week 24. 31% required an increase in dosage of rosuvastatin to 20 mg at week 12. Compliance enhancement tools did not increase the number of patients achieving either the 1998 or the 2003 European target for plasma lipids. Rosuvastatin was well tolerated during this study. The safety profile was comparable with other drugs of the same class. 63 patients in the 10 mg group and 58 in the 10 mg Plus group discontinued treatment. The main reasons for discontinuation were adverse events (39 patients in the 10 mg group; 35 patients in the 10 mg Plus group) and loss to follow-up (13 patients in the 10 mg group; 9 patients in the 10 mg Plus group). The two most frequently reported adverse events were myalgia (34 patients, 3% respectively) and back pain (23 patients, 2% respectively). The overall rate of temporary or permanent study discontinuation due to adverse events was 9% (n = 101) in patients receiving 10 mg rosuvastatin and 3% (n = 9) in patients titrated up to 20 mg rosuvastatin. Rosuvastatin was effective in lowering LDL-C values in patients with hypercholesterolaemia to the 1998 European target at week 24. However, compliance enhancement tools did not increase the number of patients achieving any European targets for plasma lipids.

The Korean language version of the Health Behavior Schedule-II as a predictor of compliance

Abstract This study is a preliminary psychometric evaluation of the Korean language version of the Health Behavior Schedule-II as a predictor of compliance or adherence to 12 health related habits. The 12 habits are (1) performing breast self-exams; (2) obtaining pap smear screens; (3) taking medication as prescribed; (4) not smoking cigarettes; (5) wearing a bike safety helmet (if applicable); (6) protecting skin from sun; (7) flossing teeth daily; (8) wearing a seat-belt; (9) limiting alcohol consumption; (10) practicing safe sex; (11) exercising regularly; and (12) eating a healthy diet. Predictors of compliance on the Schedule include 45 situational and behavioral competency factors. Past studies have shown the Schedule to be useful for a multiethnic sample of university students in Honolulu, USA and for a mono-ethnic university sample in Stuttgart, Germany. Among a mono-ethnic university sample in Seoul, Republic of Korea, this study found the Korean version of the Schedule yielded acceptable internal consistency and stability reliability estimates. Construct validity was supported for prediction of compliance to 11 of the 12 health behaviors. Compliance enhancement implications are offered.

Topiramate for Treating Alcohol Dependence&lt;SUBTITLE&gt;A Randomized Controlled Trial&lt;/SUBTITLE&gt;

Hypothetically, topiramate can improve drinking outcomes among alcohol-dependent individuals by reducing alcohol's reinforcing effects through facilitation of gamma-aminobutyric acid function and inhibition of glutaminergic pathways in the corticomesolimbic system. To determine if topiramate is a safe and efficacious treatment for alcohol dependence. Double-blind, randomized, placebo-controlled, 14-week trial of 371 men and women aged 18 to 65 years diagnosed with alcohol dependence, conducted between January 27, 2004, and August 4, 2006, at 17 US sites. Up to 300 mg/d of topiramate (n = 183) or placebo (n = 188), along with a weekly compliance enhancement intervention. Primary efficacy variable was self-reported percentage of heavy drinking days. Secondary outcomes included other self-reported drinking measures (percentage of days abstinent and drinks per drinking day) along with the laboratory measure of alcohol consumption (plasma gamma-glutamyltransferase). Treating all dropouts as relapse to baseline, topiramate was more efficacious than placebo at reducing the percentage of heavy drinking days from baseline to week 14 (mean difference, 8.44%; 95% confidence interval, 3.07%-13.80%; P = .002). Prespecified mixed-model analysis also showed that topiramate compared with placebo decreased the percentage of heavy drinking days (mean difference, 16.19%; 95% confidence interval, 10.79%-21.60%; P < .001) and all other drinking outcomes (P < .001 for all comparisons). Adverse events that were more common with topiramate vs placebo, respectively, included paresthesia (50.8% vs 10.6%), taste perversion (23.0% vs 4.8%), anorexia (19.7% vs 6.9%), and difficulty with concentration (14.8% vs 3.2%). Topiramate is a promising treatment for alcohol dependence. clinicaltrials.gov Identifier: NCT00210925.

Assessment of Determinants of Compliance to Twelve Health Behaviors: Psychometric Evaluation of the Health Behavior Schedule II

The test-retest reliability and content and construct validity of the Health Behavior Schedule II were examined. The Health Behavior Schedule II is a self-report intended to assess 45 potential predictors of compliance for 12 mainstream health practices: (1) eating a healthy diet, (2) exercising regularly, (3) flossing teeth daily, (4) protecting skin from sun, (5) wearing a seat belt, (6) practicing safe sex, (7) wearing a bike safety helmet, (8) not smoking cigarettes, (9) limiting alcohol consumption, (10) taking medication as prescribed, (11) obtaining cervical cancer screen, and (12) breast self-examination. The predictor items of the Health Behavior Schedule II were rationally derived from the Health Compliance Model-II and independently evaluated by three expert judges for content validity. The psychometric status of the Schedule was assessed using a multiethnic sample of 461 college students. 12 stepwise multiple regression analyses yielded 24 items as significant predictors of compliance. The configuration of predictor items varied across the 12 health behaviors with self-efficacy as the only common predictor. Effect size estimates were greatest for cervical cancer screening (R2 = .65) and least for breast self-exams (R2 = .38). Each predictor has implications for compliance enhancement strategies. These findings provide preliminary support for the utility of the questionnaire in assessing potential improvements in health compliance outcomes among young adults.