Research Clinic (research + clinic)

Distribution by Scientific Domains


Selected Abstracts


Cost and cost-effectiveness of standard methadone maintenance treatment compared to enriched 180-day methadone detoxification

ADDICTION, Issue 6 2004
Carmen L. Masson
ABSTRACT Aims To compare the cost and cost-effectiveness of methadone maintenance treatment and 180-day methadone detoxification enriched with psychosocial services. Design Randomized controlled study conducted from May 1995 to April 1999. Setting Research clinic in an established drug treatment program. Participants One hundred and seventy-nine adults with diagnosed opioid dependence. Intervention Patients were randomized to methadone maintenance (n = 91), which required monthly 1 hour/week of psychosocial therapy during the first 6 months or 180-day detoxification (n = 88), which required 3 hours/week of psychosocial therapy and 14 education sessions during the first 6 months. Measurements Total health-care costs and self-reported injection drug use. A two-state Markov model was used to estimate quality-adjusted years of survival. Findings Methadone maintenance produced significantly greater reductions in illicit opioid use than 180-day detoxification during the last 6 months of treatment. Total health-care costs were greater for maintenance than detoxification treatment ($7564 versus $6687; P < 0.001). Although study costs were significantly higher for methadone maintenance than detoxification patients ($4739 versus $2855, P < 0.001), detoxification patients incurred significantly higher costs for substance abuse and mental health care received outside the study. Methadone maintenance may provide a modest survival advantage compared with detoxification. The cost per life-year gained is $16 967. Sensitivity analysis revealed a cost-effectiveness ratio of less than $20 000 per quality-adjusted life-year over a wide range of modeling assumptions. Conclusions Compared with enriched detoxification services, methadone maintenance is more effective than enriched detoxification services with a cost-effectiveness ratio within the range of many accepted medical interventions and may provide a survival advantage. Results provide additional support for the use of sustained methadone therapy as opposed to detoxification for treating opioid addiction. [source]


Sensitivity and Specificity of the Mini-Mental State Examination for Identifying Dementia in the Oldest-Old: The 90+ Study

JOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 2 2007
Kristin Kahle-Wrobleski PhD
OBJECTIVES: To evaluate the sensitivity and specificity of the Mini-Mental State Examination (MMSE) in identifying dementia in the oldest-old when stratified by age and education. DESIGN: Cross-sectional. SETTING: Research clinic and in-home visits. PARTICIPANTS: Population-based sample of adults aged 90 and older (n=435) who are enrolled in the 90+ Study, a longitudinal, population-based study. MEASUREMENTS: Neurological examination to determine dementia diagnosis, MMSE, and demographic data. RESULTS: Receiver operating characteristic (ROC) analyses indicated that the MMSE had high diagnostic accuracy for identifying dementia in subjects aged 90 and older across different age and education groups (area under the ROC curve values ranged from 0.82 to 0.98). A range of possible cutoff values and corresponding sensitivity and specificity are provided for the following age groups: 90,93, 94,96, and ,97. Age groups were subdivided by educational attainment (,high school, vocational school or some college, college degree or higher). In subjects aged 90 to 93 with a college degree or higher, the suggested MMSE cutoff score is ,25 (sensitivity=0.82, specificity=0.80). In those aged 94 to 96 with a college degree or higher, the suggested cutoff is ,24 (sensitivity=0.85, specificity=0.80). Those aged 97 and older with an education of high school or less had the lowest suggested cutoff ,22 (sensitivity=0.80, specificity=0.76). CONCLUSION: Overall, the MMSE had good sensitivity and specificity across all age and educational groups. Optimal cutoff points were lower in the older age groups and those with less education, primarily to preserve specificity. This screening instrument is appropriate for use with the oldest-old. [source]


Performance-Based Measures of Physical Function for High-Function Populations

JOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 5 2006
J. David Curb MD
OBJECTIVES: To improve and broaden the applicability of performance-based measures of function for use in clinical and research settings. DESIGN: Cross-sectional repeated-measures study. SETTING: Research clinic. PARTICIPANTS: Population-based sample of Japanese Americans without significant functional impairments aged 35 to 55 and 56 to 71 (N=203). MEASUREMENTS: Performance-based measures of physical function, including range of standard tests, newer automated measures of balance and strength and data on cognitive function, lifestyle, medical history, and physical activity. RESULTS: Of the nonplatform balance measures, only the one-leg stand was reliable (reliability coefficient (rc) =0.69) and able to discriminate between functional levels. Combining the Fourth National Health and Nutrition Examination Survey protocol of folded arm position while standing on a foam pad with the more-sophisticated balance platform test had the highest reliability and discrimination. With the strength chair, high rcs (0.88,0.96) were found for upper and lower extremity tests. Timed chair stands, a test of lower extremity and central strength were reliable. The 6-minute walk had a high rc (0.90). CONCLUSION: Many performance tests used today are not reliable. Only a few discriminate between the most highly functioning individuals and individuals with good function. Thus, a new recommended battery includes unassisted single-leg stand, balance platform "foam pad, eyes closed," elbow flexion and knee extension strength (strength chair), grip strength, timed chair stands, and the 6-minute walk. These simple performance-based tests have good reliability and discrimination across the range of function and can be used in most clinical and research settings to quickly assess global functional level. [source]


Automation in an addiction treatment research clinic: Computerised contingency management, ecological momentary assessment and a protocol workflow system

DRUG AND ALCOHOL REVIEW, Issue 1 2009
MASSOUD VAHABZADEH
Abstract Introduction and Aims. A challenge in treatment research is the necessity of adhering to protocol and regulatory strictures while maintaining flexibility to meet patients' treatment needs and to accommodate variations among protocols. Another challenge is the acquisition of large amounts of data in an occasionally hectic environment, along with the provision of seamless methods for exporting, mining and querying the data. Design and Methods. We have automated several major functions of our outpatient treatment research clinic for studies in drug abuse and dependence. Here we describe three such specialised applications: the Automated Contingency Management (ACM) system for the delivery of behavioural interventions, the transactional electronic diary (TED) system for the management of behavioural assessments and the Protocol Workflow System (PWS) for computerised workflow automation and guidance of each participant's daily clinic activities. These modules are integrated into our larger information system to enable data sharing in real time among authorised staff. Results. ACM and the TED have each permitted us to conduct research that was not previously possible. In addition, the time to data analysis at the end of each study is substantially shorter. With the implementation of the PWS, we have been able to manage a research clinic with an 80 patient capacity, having an annual average of 18 000 patient visits and 7300 urine collections with a research staff of five. Finally, automated data management has considerably enhanced our ability to monitor and summarise participant safety data for research oversight. Discussion and Conclusions. When developed in consultation with end users, automation in treatment research clinics can enable more efficient operations, better communication among staff and expansions in research methods. [Vahabzadeh M, Lin J-L, Mezghanni M, Epstein DH, Preston KL. Automation in an addiction treatment research clinic: Computerised contingency management, ecological momentary assessment and a protocol workflow system. Drug Alcohol Rev 2009;28:3,11] [source]


Extended treatment of older cigarette smokers

ADDICTION, Issue 6 2009
Sharon M. Hall
ABSTRACT Aims Tobacco dependence treatments achieve abstinence rates of 25,30% at 1 year. Low rates may reflect failure to conceptualize tobacco dependence as a chronic disorder. The aims of the present study were to determine the efficacy of extended cognitive behavioral and pharmacological interventions in smokers , 50 years of age, and to determine if gender differences in efficacy existed. Design Open randomized clinical trial. Setting A free-standing, smoking treatment research clinic. Participants A total of 402 smokers of , 10 cigarettes per day, all 50 years of age or older. Intervention Participants completed a 12-week treatment that included group counseling, nicotine replacement therapy (NRT) and bupropion. Participants, independent of smoking status, were then assigned randomly to follow-up conditions: (i) standard treatment (ST; no further treatment); (ii) extended NRT (E-NRT; 40 weeks of nicotine gum availability); (iii) extended cognitive behavioral therapy (E-CBT; 11 cognitive behavioral sessions over a 40-week period); or (iv) E-CBT plus E-NRT (E-combined; 11 cognitive behavioral sessions plus 40 weeks nicotine gum availability). Measurements Primary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at weeks 24, 52, 64 and 104. Findings The most clinically important findings were significant main effects for treatment condition, time and the treatment × time interaction. The E-CBT condition produced high cigarette abstinence rates that were maintained throughout the 2-year study period [(week 24 (58%), 52 (55%), 64 (55%) and 104 (55%)], and was significantly more effective than E-NRT and ST across that period. No other treatment condition was significantly different to ST. No effects for gender were found. Conclusions Extended cognitive behavioral treatments can produce high and stable cigarette abstinence rates for both men and women. NRT does not add to the efficacy of extended CBT, and may hamper its efficacy. Research is needed to determine if these results can be replicated in a sample with a greater range of ages, and improved upon with the addition of medications other than NRT. [source]


Effects of varying the monetary value of voucher-based incentives on abstinence achieved during and following treatment among cocaine-dependent outpatients

ADDICTION, Issue 2 2007
Stephen T. Higgins
ABSTRACT Aims This study examined whether increasing the amount of abstinence achieved during outpatient treatment for cocaine dependence is an effective method for increasing longer-term cocaine abstinence. Design A two-condition, parallel groups, randomized controlled trial was conducted. Setting The trial was conducted in a university-based research clinic. Participants A total of 100 cocaine-dependent outpatients participated in the trial. Intervention Participants were assigned randomly to receive treatment based on the community reinforcement approach (CRA) plus voucher-based incentives set at a relatively high monetary value (maximal value = $1995/12 weeks) or CRA with vouchers set at a relatively low monetary value (maximal value = $499/12 weeks). Vouchers were earned contingent on cocaine-negative urinalysis results during the initial 12 weeks of the 24-week outpatient treatment. Measurements Outcomes were evaluated using urine-toxicology testing, questionnaires and other self-report instruments. Findings Increasing voucher value increased the duration of continuous cocaine abstinence achieved during the 24-week treatment period. Point-prevalence cocaine abstinence assessed every 3 months throughout an 18-month follow-up period was greater in the high- than low-value voucher conditions. The duration of abstinence achieved during treatment predicted abstinence during follow-up, although that relationship weakened over time. Conclusions Increasing the value of abstinence-contingent incentives during the initial weeks of treatment appears to represent an effective method for increasing during-treatment and longer-term cocaine abstinence, but the positive association of during-treatment abstinence with longer-term outcome dissipates with time. [source]


Use of the Late-Life Function and Disability Instrument to Assess Disability in Major Depression

JOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 9 2009
Jordan F. Karp MD
OBJECTIVES: To determine whether there was greater disability in subjects with depression than in those without, the correlation between disability and depression severity and quality of life, and whether improvement in disability after antidepressant pharmacotherapy was greater in those who responded to antidepressant treatment. DESIGN: Disability in subjects with and without depression from two different studies was compared for 22 weeks. Correlations were performed for the subjects with depression between disability and depression, anxiety, health-related quality of life (HRQOL), and medical comorbidity. T -tests were used to compare disability between subjects who did and did not respond to antidepressant treatment and change in disability after pharmacotherapy. SETTING: Late-life depression research clinic. PARTICIPANTS: The 313 subjects were recruited from primary care and the community and were aged 60 and older; 244 subjects were participants in a depression treatment protocol, and 69 subjects without depression participated in a separate longitudinal observational study of the mental and cognitive health of depression-free older adults. MEASUREMENTS: The Late-Life Function and Disability Instrument (LL-FDI), a measure of instrumental activity of daily living, personal role, and social role functioning. RESULTS: Subjects with depression scored lower than controls for domains measuring limitation (can do) and frequency (does do) of activities. Both disability domains correlated with depression severity, anxiety, HRQOL, and cognition. Disability improved with antidepressant treatment; for partial responders who continued to receive higher-dose antidepressant treatment out to 22 weeks, there was continued improvement, although not to the level of comparison subjects without depression. CONCLUSION: The LL-FDI appears to discriminate subjects with depression from those without, correlates with depression severity, and demonstrates sensitivity to antidepressant treatment response. We recommend further investigation of the LL-FDI and similar disability instruments for assessing depression-related disability. [source]


Prevalence of chronic bronchitis and chronic respiratory symptoms in adults over the age of 35 years in Isfahan, Iran in 1998

RESPIROLOGY, Issue 3 2001
Mohammad Golshan
Objective: Chronic obstructive airways disease (COPD) in older patients is reported to be not only common, but also frequently overlooked and untreated by general practitioners. Chronic bronchitis is one of the major components of COPD and can be readily screened. This study investigates the prevalence of chronic bronchitis and related symptoms in Iran with special reference to COPD. Methodology: A random sample of 4636 participants aged 35 years and over, attended a research clinic for interview and physical examinations. Those reporting classic symptoms of chronic bronchitis were referred to a pulmonary clinic for pulmonary function testing. Results: Two hundred and sixteen patients (4.65%) had chronic bronchitis. Among these, 78 (36.1%) had obstructive airways disease. Decreased forced expiratory volume in 1 s/forced vital capacity to levels of less than 70% were recorded in 45 patients (42.9% of the tested population). Less than 25% of the patients had a previous diagnosis of chronic bronchitis and/or airways disease. Conclusion: Obstructive airway diseases are under-diagnosed in developing countries. Physicians practising in such areas of the world should be aware, and try to detect the subclinical illnesses, especially in urban areas. [source]


A randomised controlled trial of cytological surveillance versus patient choice between surveillance and colposcopy in managing mildly abnormal cervical smears

BJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 1 2004
H.C. Kitchener
Objective To determine whether choice of colposcopy or six month cytological surveillance would be beneficial to women with mildly abnormal smears when compared with the national policy of six months surveillance in terms of psychological morbidity. Design A randomised trial based on the Zelen design. Setting A hospital-based research clinic. Population Four hundred and seventy-six women who had had a recurrent borderline or mildly dyskaryotic smear on routine cervical screening in primary care. Methods Women were randomised either to six months cytological surveillance or to make a choice between that or colposcopy and were followed up for 1 year. Main outcome measures The primary outcome measure was caseness (score ,4) on the General Health Questionnaire at 12 months follow up. Other measures were the Spielberger State and Trait scores, default rates and cytology/colposcopy outcomes. Results There was no significant difference between the arms for General Health Questionnaire (GHQ) scores and Spielberger State and Trait at 12 months. There was a significant reduction in psychometric morbidity between baseline and 12 months in both arms. Overall rates of default from the protocol were the same in both arms, but default that led to uncertain ascertainment of cervical pathology was greater in the no-choice arm. Conclusions This trial indicates that having choice did not impact favourably or harmfully on anxiety or feelings of wellbeing. If a patient is anxious, allowing the patient to choose immediate colposcopy may be preferable because it will improve ascertainment of underlying disease in a group who are more likely to default. [source]


Developing a strategy to reduce the high morbidity of patients with long-term urinary catheters: the BioMed catheter research clinic

BJU INTERNATIONAL, Issue 6 2007
Azhar A. Khan
OBJECTIVE To assess the idea of managing patients having problems with long-term catheterization (LTC, normally used when all other methods of bladder management have failed or are unsuitable) in a dedicated clinic, to present a prospective analysis of consecutive new patients attending between February 2002 and October 2006, and to establish the incidence of bladder stones in patients who have recurrent catheter encrustation and blockage. PATIENTS AND METHODS Patients treated with LTC are a large heterogeneous group, mainly consisting of elderly people who have chronic disabilities, and catheter-associated complications occur in > 70% of them. In all, 260 consecutive new patients having problems with LTC were assessed; the evaluation consisted of basic demographics, a detailed history, clinical examination, urine analysis and flexible cystoscopy (FC) via the catheterization route. Patients with bladder stones were screened with FC for recurrence of stones at 3, 6 and 12 months after treatment. RESULTS In all, 117 men and 143 women (mean age 67.7 years, range 23,97) were assessed; 147 (55.5%) had catheter encrustation. FC showed that 66 of the 147 patients (45%) had bladder stones. Forty-eight patients (73%) were successfully treated at the same clinic appointment and their stones were removed with the help of a tip-less stone basket. Eighteen patients (27%) were referred for inpatient treatment of bladder stones under general anaesthesia. Twenty of 66 patients with bladder stones (30%) formed recurrent bladder stones at a mean (range) follow-up of 8.1 (3,18 months). In addition, 36 patients had successful insertion of suprapubic catheter (SPC) under local anaesthetic in the clinic, and 11 were referred for SPC insertion under general anaesthesia. Two patients were diagnosed with bladder transitional cell carcinoma. CONCLUSION The introduction of a dedicated catheter clinic, equipped with facilities such as FC and a hoist, enables patients to be treated in an environment that meets their needs and potentially reduces the risk of more complex stone removal and catheter problems at a later date. It can also act as a potential source of data for use in research and development. A significant proportion (45%) of patients with catheter encrustation and blockage had formed bladder stones. Our study provides a rationale for FC of all such patients to detect and remove stones. [source]


Automation in an addiction treatment research clinic: Computerised contingency management, ecological momentary assessment and a protocol workflow system

DRUG AND ALCOHOL REVIEW, Issue 1 2009
MASSOUD VAHABZADEH
Abstract Introduction and Aims. A challenge in treatment research is the necessity of adhering to protocol and regulatory strictures while maintaining flexibility to meet patients' treatment needs and to accommodate variations among protocols. Another challenge is the acquisition of large amounts of data in an occasionally hectic environment, along with the provision of seamless methods for exporting, mining and querying the data. Design and Methods. We have automated several major functions of our outpatient treatment research clinic for studies in drug abuse and dependence. Here we describe three such specialised applications: the Automated Contingency Management (ACM) system for the delivery of behavioural interventions, the transactional electronic diary (TED) system for the management of behavioural assessments and the Protocol Workflow System (PWS) for computerised workflow automation and guidance of each participant's daily clinic activities. These modules are integrated into our larger information system to enable data sharing in real time among authorised staff. Results. ACM and the TED have each permitted us to conduct research that was not previously possible. In addition, the time to data analysis at the end of each study is substantially shorter. With the implementation of the PWS, we have been able to manage a research clinic with an 80 patient capacity, having an annual average of 18 000 patient visits and 7300 urine collections with a research staff of five. Finally, automated data management has considerably enhanced our ability to monitor and summarise participant safety data for research oversight. Discussion and Conclusions. When developed in consultation with end users, automation in treatment research clinics can enable more efficient operations, better communication among staff and expansions in research methods. [Vahabzadeh M, Lin J-L, Mezghanni M, Epstein DH, Preston KL. Automation in an addiction treatment research clinic: Computerised contingency management, ecological momentary assessment and a protocol workflow system. Drug Alcohol Rev 2009;28:3,11] [source]


Cocaine Rapid Efficacy Screening Trial (CREST): a paradigm for the controlled evaluation of candidate medications for cocaine dependence

ADDICTION, Issue 2005
Deborah B. Leiderman
ABSTRACT Aim Development of effective medications for the treatment of cocaine dependence remains a major priority for the National Institute on Drug Abuse (NIDA) at the National Institutes of Health. The Cocaine Rapid Efficacy Screening Trial (CREST) paradigm was developed by the Division of Treatment Research and Development (DT R&D) at NIDA with the goal of enhancing pilot clinical trial validity when systematically assessing a range of medications and drug classes for potential utility in treatment of cocaine dependence. Design CREST utilizes a randomized, controlled, parallel group, blinded methodology for comparing one or more marketed medications against a standard, pharmaceutical grade placebo. The trial design is comprised of a flexible 2,4-week screening/baseline period followed by randomization to an 8-week treatment period. Measures Standard measures of outcomes for the CREST included urinary benzoylecgonine (primary metabolite of cocaine), retention, cocaine craving, depression, clinical global impression and HIV-risk behaviors. In order to facilitate comparisons of data from the CREST studies across sites, drug classes and time, standardized procedures, measures and psychosocial counseling were used. Results A total of 19 medications were evaluated in out-patient treatment research clinics in Boston, Cincinnati, Los Angeles, New York and Philadelphia. Conclusions Findings supported decisions to move forward three medications (cabergoline, reserpine, tiagabine) using full-scale, adequately powered, randomized placebo-controlled trial designs. Lessons learned from the CREST experience continue to shape cocaine pharmacotherapy trial design and execution. [source]


Health-related quality of life in a cohort of adult patients with mild hemophilia A

JOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 5 2008
M. WALSH
Summary.,Objectives:,To compare the health-related quality of life among adult males affected with mild hemophilia A due to the same mutation (Val2016ala) to that of unaffected age and sex matched controls from the same general population. Methods:,The Short-Form 36 (SF-36) and Health Assessment Questionnaire (HAQ) were used to measure health-related quality of life and physical function. Other measures included bleeding history, a measure of joint damage, body mass index, age, and viral infection status. Cross-sectional data were collected through research clinics and a retrospective chart audit over a two-year period. Results and Conclusions:,The study included 47 affected males and 33 controls. The affected males had a higher level of co-morbidity, prior bleeding, and existing joint damage than controls. With the exception of the social function and health transition scales, mean scores for each of the SF-36 domains were worse among affected males. Mean differences were more than a clinically important five points in five of eight domains, with the general health scale showing more than a 10-point difference. Despite the degree of difference noted, only two of the differences were statistically significant (general health and role emotional scales) because of the small sample size and considerable individual variation in SF-36 scale scores. Multiple regression analyses suggested existing joint damage and presence of heart disease as the strongest associates of lower physical health-related quality of life. Joint damage in turn was partly related to prior hemarthroses. Compared to the Canadian population, affected males had lower scores in six out of eight SF-36 domains as well as the physical component summary score. There were no significant differences found in the HAQ scores between the two groups. So-called mild hemophilia A was associated with a negative effect on physical health-related quality of life, contributed to by joint damage as a result of prior bleeding. [source]