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1.  Baseline participant characteristics and risk for dropout from ten obesity randomized controlled trials: a pooled analysis of individual level data 
Frontiers in nutrition  2014;1(25):00025.
Understanding participant demographic characteristics that inform the optimal design of obesity RCTs have been examined in few studies. The objective of this study was to investigate the association of individual participant characteristics and dropout rates (DORs) in obesity randomized controlled trials (RCT) by pooling data from several publicly available datasets for analyses. We comprehensively characterize DORs and patterns in obesity RCTs at the individual study level, and describe how such rates and patterns vary as a function of individual-level characteristics.
We obtained and analyzed nine publicly-available, obesity RCT datasets that examined weight loss or weight gain prevention as a primary or secondary endpoint. Four risk factors for dropout were examined by Cox proportional hazards including sex, age, baseline BMI, and race/ethnicity. The individual study data were pooled in the final analyses with a random effect for study, and HR and 95% CIs were computed.
Results of the multivariate analysis indicated that the risk of dropout was significantly higher for females compared to males (HR= 1.24, 95% CI = 1.05, 1.46). Hispanics and Non-Hispanic blacks had a significantly higher dropout rate compared to non-Hispanic whites (HR= 1.62, 95% CI = 1.37, 1.91; HR= 1.22, 95% CI = 1.11, 1.35, respectively). There was a significantly increased risk of dropout associated with advancing age (HR= 1.02, 95% CI = 1.01, 1.02) and increasing BMI (HR= 1.03, 95% CI = 1.03, 1.04).
As more studies may focus on special populations, researchers designing obesity RCTs may wish to oversample in certain demographic groups if attempting to match comparison groups based on generalized estimates of expected dropout rates, or otherwise adjust a priori power estimates. Understanding true reasons for dropout may require additional methods of data gathering not generally employed in obesity RCTs, e.g. time on treatment.
PMCID: PMC4296899  PMID: 25599077
obesity; pooled analysis; randomized trials; dropout; participant characteristics
2.  Impact of Educational Level on Study Attrition and Evaluation of Web-Based Computer-Tailored Interventions: Results From Seven Randomized Controlled Trials 
Web-based computer-tailored interventions have shown to be effective in improving health behavior; however, high dropout attrition is a major issue in these interventions.
The aim of this study is to assess whether people with a lower educational level drop out from studies more frequently compared to people with a higher educational level and to what extent this depends on evaluation of these interventions.
Data from 7 randomized controlled trials of Web-based computer-tailored interventions were used to investigate dropout rates among participants with different educational levels. To be able to compare higher and lower educated participants, intervention evaluation was assessed by pooling data from these studies. Logistic regression analysis was used to assess whether intervention evaluation predicted dropout at follow-up measurements.
In 3 studies, we found a higher study dropout attrition rate among participants with a lower educational level, whereas in 2 studies we found that middle educated participants had a higher dropout attrition rate compared to highly educated participants. In 4 studies, no such significant difference was found. Three of 7 studies showed that participants with a lower or middle educational level evaluated the interventions significantly better than highly educated participants (“Alcohol-Everything within the Limit”: F 2,376=5.97, P=.003; “My Healthy Behavior”: F 2,359=5.52, P=.004; “Master Your Breath”: F 2,317=3.17, P=.04). One study found lower intervention evaluation by lower educated participants compared to participants with a middle educational level (“Weight in Balance”: F 2,37=3.17, P=.05). Low evaluation of the interventions was not a significant predictor of dropout at a later follow-up measurement in any of the studies.
Dropout attrition rates were higher among participants with a lower or middle educational level compared with highly educated participants. Although lower educated participants evaluated the interventions better in approximately half of the studies, evaluation did not predict dropout attrition. Further research is needed to find other explanations for high dropout rates among lower educated participants.
PMCID: PMC4642402  PMID: 26446779
dropout; attrition; educational level; computer tailoring; Web-based intervention; eHealth; evaluation; meta-analysis
3.  Effect of Black Tea Intake on Blood Cholesterol Concentrations in Individuals with Mild Hypercholesterolemia: A Diet-Controlled Randomized Trial 
Habitual intake of black tea has been associated with relatively lower serum cholesterol concentrations in observational studies. However, clinical trial results evaluating the effects of black tea on serum cholesterol have been inconsistent. Several factors could explain these mixed results, in particular, uncontrolled confounding caused by lifestyle factors, e.g. diet. This diet-controlled clinical trial estimates the effect of black tea flavonoid consumption on cholesterol concentrations in 57 borderline hypercholesterolemic individuals (total cholesterol concentrations between 190 and 260 mg/dl (4.9 and 6.7 mmol/L)). A double blind, randomized crossover trial was conducted in Minneapolis, MN from April 2002 through April 2004, wherein key conditions were tightly controlled to minimize possible confounding. Participants consumed a controlled low-flavonoid diet plus 5 cups per day of black tea or tea-like placebo over two 4-week treatment periods. The flavonoid-free caffeinated placebo matched the tea in color and taste. Differences in cholesterol concentrations at the end of each treatment period were evaluated via linear mixed models. Differences (95% CI) in mg/dl among those treated with tea versus placebo were 3.43 (−7.08, 13.94) for total cholesterol, −1.02 (−11.34, 9.30) for low-density lipoprotein cholesterol (LDL-C), 0.58 (−2.98, 4.14) for high-density lipoprotein cholesterol (HDL-C), 15.22 (−40.91, 71.35) for triglycerides, and −0.39 (−11.16, 10.38) for LDL plus HDL cholesterol fraction. The LCL-C/HDL-C ratio decreased by −0.1 units (95% CI −0.41, 0.21). No results were statistically or clinically significant. Thus, the intake of 5 cups of black tea per day did not significantly alter the lipid profile of borderline hypercholesterolemic subjects.
PMCID: PMC4312726  PMID: 25266246
serum lipids; hypercholesterolemia; black tea; flavonoids; randomized crossover control trial
4.  Maintenance Treatment With Varenicline for Smoking Cessation in Patients With Schizophrenia and Bipolar Disorder 
It is estimated that more than half of those with serious mental illness smoke tobacco regularly. Standard courses of pharmacotherapeutic cessation aids improve short-term abstinence, but most who attain abstinence relapse rapidly after discontinuation of pharmacotherapy.
To determine whether smokers diagnosed with schizophrenia and bipolar disease have higher rates of prolonged tobacco abstinence with maintenance pharmacotherapy than with standard treatment.
Design, Setting, and Participants
Randomized, double-blind, placebo-controlled, parallel-group, relapse-prevention clinical trial conducted in 10 community mental-health centers. Of 247 smokers with schizophrenia or bipolar disease recruited from March 2008-April 2012, 203 received 12-weeks' open-label varenicline and cognitive behavioral therapy and 87 met abstinence criteria to enter the relapse prevention intervention.
Participants who had 2 weeks or more of continuous abstinence at week 12 of open treatment were randomly assigned to receive cognitive behavioral therapy and double-blind varenicline (1 mg, 2 per day) or placebo from weeks 12 to 52. Participants then discontinued study treatment and were followed up to week 76.
Main Outcomes and Measures
Seven-day rate of continuous abstinence at study week 52, the end of the relapse-prevention phase, confirmed by exhaled carbon monoxide. Secondary outcomes were continuous abstinence rates for weeks 12 through 64 based on biochemically verified abstinence and weeks 12 through 76, based on self-reported smoking behavior.
Sixty-one participants completed the relapse-prevention phase; 26 discontinued participation (7 varenicline, 19 placebo) and were considered to have relapsed for the analyses; 18 of these had relapsed prior to dropout. At week 52, point-prevalence abstinence rates were 60% in the varenicline group (24 of 40) vs 19% (9 of 47) in the placebo group (odds ratio [OR], 6.2; 95% CI, 2.2-19.2; P < .001). From weeks 12 through 64,45% (18 of 40) among those in the varenicline group vs 15% (7 of 47) in the placebo group were continuously abstinent (OR, 4.6; 95% CI, 1.5-15.7; P = .004), and from weeks 12 through 76,30% (12 of 40) in the varenicline group vs 11% (5 of 47) in the placebo group were continuously abstinent (OR, 3.4; 95% CI, 1.02-13.6; P = .03). There were no significant treatment effects on psychiatric symptom ratings or psychiatric adverse events.
Conclusions and Relevance
Among smokers with serious mental illness who attained initial abstinence with standard treatment, maintenance pharmacotherapy with varenicline and cognitive behavioral therapy improved prolonged tobacco abstinence rates compared with cognitive behavioral therapy alone after 1 year of treatment and at 6 months after treatment discontinuation.
PMCID: PMC4124884  PMID: 24399553
5.  Retention and Attrition Among African Americans in the STAR*D Study: What Causes Research Volunteers to Stay or Stray? 
Depression and anxiety  2013;30(11):10.1002/da.22134.
High attrition rates among African-Americans (AA) volunteers are a persistent problem that makes clinical trials less representative and complicates estimation of treatment outcomes. Many studies contrast AA with other ethnic/racial groups, but few compare the AA volunteers who remain in treatment with those who leave. Here, in addition to comparing patterns of attrition between African Americans and whites, we identify predictors of overall and early attrition among African Americans.
Sample comprised non-Hispanic African-American (n=673) and white (n=2,549) participants in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. Chi-square tests were used to examine racial group differences in reasons for exit. Multivariate logistic regression was used to examine predictors of overall attrition, early attrition (by Level 2) and top reasons cited for attrition among African Americans.
For both African-American and white dropouts, non-compliance reasons for attrition were most commonly cited during the earlier phases of the study while reasons related to efficacy and medication side effects were cited later in the study. Satisfaction with treatment strongly predicted overall attrition among African Americans independent of socioeconomic, clinical, medical or psychosocial factors. Early attrition among African American dropouts was associated with less psychiatric comorbidity, and higher perceived physical functioning but greater severity of clinician-rated depression.
The decision to drop out is a dynamic process that changes over the course of a clinical trial. Strategies aimed at retaining African Americans in such trials should emphasize engagement with treatment and patient satisfaction immediately following enrollment and after treatment initiation.
PMCID: PMC3818393  PMID: 23723044
Research Volunteers; Ethnic Groups; Blacks; Depression; Disparities; Treatment
6.  Dropout from Outpatient Mental Health Care in the United States 
Although mental health treatment dropout is common, patterns and predictors of dropout are poorly understood. This study explores patterns and predictors of mental health treatment dropout in a nationally representative sample.
Data come from the National Comorbidity Survey Replication (NCS-R), a nationally representative household survey. Respondents in mental health treatment in the 12 months (n=1,664) before interview were asked about dropout defined as quitting treatment before the provider wanted. Cross-tabulation and discrete-time survival analyses were used to identify predictors.
Approximately one-fifth (22.4%) of patients quit treatment prematurely. The highest dropout rate was from the general medical sector (31.6%) and the lowest was from psychiatrists (15.1%). Dropout rates were intermediate in the human service sector (19.7%) and among patients seen by non-psychiatrist mental health professionals (18.9%). Over 70% of all dropout occurred after the first or second visits. Mental health insurance was associated with low odds of dropout (0.6, 0.4–0.9). Psychiatric comorbidity was associated with a trend towards dropout. Several patient characteristics differentially predicted dropout across treatment sectors and in early and later phases of treatment.
Roughly one-fifth of adults in mental health treatment each year drop out before completing the recommended course of treatment. Dropout is most common in the general medical sector and varies by patient characteristics across treatment sectors. Interventions focused on high-risk patients and sectors will likely be required to reduce the high proportion of patients who prematurely terminate treatment.
PMCID: PMC2774713  PMID: 19564219
Mental health treatment adherence; treatment dropout; termination of treatment
7.  Baseline Participant Characteristics and Risk for Dropout from 10 Obesity Randomized Controlled Trials: A Pooled Analysis of Individual Level Data 
Introduction: Understanding participant demographic characteristics that inform the optimal design of obesity randomized controlled trials (RCTs) have been examined in few studies. The objective of this study was to investigate the association of individual participant characteristics and dropout rates (DORs) in obesity RCTs by pooling data from several publicly available datasets for analyses. We comprehensively characterize DORs and patterns in obesity RCTs at the individual study level, and describe how such rates and patterns vary as a function of individual level characteristics.
Methods: We obtained and analyzed nine publicly available, obesity RCT datasets that examined weight loss or weight gain prevention as a primary or secondary endpoint. Four risk factors for dropout were examined by Cox proportional hazards including sex, age, baseline BMI, and race/ethnicity. The individual study data were pooled in the final analyses with a random effect for study, and HR and 95% CIs were computed.
Results: Results of the multivariate analysis indicated that the risk of dropout was significantly higher for females compared to males (HR = 1.24, 95% CI = 1.05, 1.46). Hispanics and Non-Hispanic blacks had a significantly higher dropout rate compared to non-Hispanic whites (HR = 1.62, 95% CI = 1.37, 1.91; HR = 1.22, 95% CI = 1.11, 1.35, respectively). There was a significantly increased risk of dropout associated with advancing age (HR = 1.02, 95% CI = 1.01, 1.02) and increasing BMI (HR = 1.03, 95% CI = 1.03, 1.04).
Conclusion/Significance: As more studies may focus on special populations, researchers designing obesity RCTs may wish to oversample in certain demographic groups if attempting to match comparison groups based on generalized estimates of expected DORs, or otherwise adjust a priori power estimates. Understanding true reasons for dropout may require additional methods of data gathering not generally employed in obesity RCTs, e.g., time on treatment.
PMCID: PMC4296899  PMID: 25599077
obesity; pooled analysis; randomized trials; dropout; participant characteristics
8.  Complementary therapies for acne vulgaris 
Acne is a chronic skin disease characterised by inflamed spots and blackheads on the face, neck, back, and chest. Cysts and scarring can also occur, especially in more severe disease. People with acne often turn to complementary and alternative medicine (CAM), such as herbal medicine, acupuncture, and dietary modifications, because of their concerns about the adverse effects of conventional medicines. However, evidence for CAM therapies has not been systematically assessed.
To assess the effects and safety of any complementary therapies in people with acne vulgaris.
Search methods
We searched the following databases from inception up to 22 January 2014: the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 1), MEDLINE (from 1946), Embase (from 1974), PsycINFO (from 1806), AMED (from 1985), CINAHL (from 1981), Scopus (from 1966), and a number of other databases listed in the Methods section of the review. The Cochrane CAM Field Specialised Register was searched up to May 2014. We also searched five trials registers and checked the reference lists of articles for further references to relevant trials.
Selection criteria
We included parallel-group randomised controlled trials (or the first phase data of randomised cross-over trials) of any kind of CAM, compared with no treatment, placebo, or other active therapies, in people with a diagnosis of acne vulgaris.
Data collection and analysis
Three authors collected data from each included trial and evaluated the methodological quality independently. They resolved disagreements by discussion and, as needed, arbitration by another author.
Main results
We included 35 studies, with a total of 3227 participants. We evaluated the majority as having unclear risk of selection, attrition, reporting, detection, and other biases. Because of the clinical heterogeneity between trials and the incomplete data reporting, we could only include four trials in two meta-analyses, with two trials in each meta-analysis. The categories of CAM included herbal medicine, acupuncture, cupping therapy, diet, purified bee venom (PBV), and tea tree oil. A pharmaceutical company funded one trial; the other trials did not report their funding sources.
Our main primary outcome was ’Improvement of clinical signs assessed through skin lesion counts’, which we have reported as ’Change in inflammatory and non-inflammatory lesion counts’, ’Change of total skin lesion counts’, ’Skin lesion scores’, and ’Change of acne severity score’. For ’Change in inflammatory and non-inflammatory lesion counts’, we combined 2 studies that compared a low- with a high-glycaemic-load diet (LGLD, HGLD) at 12 weeks and found no clear evidence of a difference between the groups in change in non-inflammatory lesion counts (mean difference (MD) −3.89, 95% confidence interval (CI) −10.07 to 2.29, P = 0.10, 75 participants, 2 trials, low quality of evidence). However, although data from 1 of these 2 trials showed benefit of LGLD for reducing inflammatory lesions (MD −7.60, 95% CI −13.52 to −1.68, 43 participants, 1 trial) and total skin lesion counts (MD −8.10, 95% CI −14.89 to −1.31, 43 participants, 1 trial) for people with acne vulgaris, data regarding inflammatory and total lesion counts from the other study were incomplete and unusable in synthesis.
Data from a single trial showed potential benefit of tea tree oil compared with placebo in improving total skin lesion counts (MD −7.53, 95% CI −10.40 to −4.66, 60 participants, 1 trial, low quality of evidence) and acne severity scores (MD −5.75, 95% CI −9.51 to −1.99, 60 participants, 1 trial). Another trial showed pollen bee venom to be better than control in reducing numbers of skin lesions (MD −1.17, 95% CI −2.06 to −0.28, 12 participants, 1 trial).
Results from the other 31 trials showed inconsistent effects in terms of whether acupuncture, herbal medicine, or wet-cupping therapy were superior to controls in increasing remission or reducing skin lesions.
Twenty-six of the 35 included studies reported adverse effects; they did not report any severe adverse events, but specific included trials reported mild adverse effects from herbal medicines, wet-cupping therapy, and tea tree oil gel.
Thirty trials measured two of our secondary outcomes, which we combined and expressed as ’Number of participants with remission’. We were able to combine 2 studies (low quality of evidence), which compared Ziyin Qinggan Xiaocuo Granule and the antibiotic, minocycline (100 mg daily) (worst case = risk ratio (RR) 0.49, 95% CI 0.09 to 2.53, 2 trials, 206 participants at 4 weeks; best case = RR 2.82, 95% CI 0.82 to 9.06, 2 trials, 206 participants at 4 weeks), but there was no clear evidence of a difference between the groups.
None of the included studies assessed ’Psychosocial function’.
Two studies assessed ’Quality of life’, and significant differences in favour of the complementary therapy were found in both of them on ’feelings of self-worth’ (MD 1.51, 95% CI 0.88 to 2.14, P < 0.00001, 1 trial, 70 participants; MD 1.26, 95% CI 0.20 to 2.32, 1 trial, 46 participants) and emotional functionality (MD 2.20, 95% CI 1.75 to 2.65, P < 0.00001, 1 trial, 70 participants; MD 0.93, 95% CI 0.17 to 1.69, 1 trial, 46 participants).
Because of limitations and concerns about the quality of the included studies, we could not draw a robust conclusion for consistency, size, and direction of outcome effects in this review.
Authors’ conclusions
There is some low-quality evidence from single trials that LGLD, tea tree oil, and bee venom may reduce total skin lesions in acne vulgaris, but there is a lack of evidence from the current review to support the use of other CAMs, such as herbal medicine, acupuncture, or wet-cupping therapy, for the treatment of this condition. There is a potential for adverse effects from herbal medicines; however, future studies need to assess the safety of all of these CAM therapies. Methodological and reporting quality limitations in the included studies weakened any evidence. Future studies should be designed to ensure low risk of bias and meet current reporting standards for clinical trials.
PMCID: PMC4486007  PMID: 25597924
9.  Tea consumption is inversely related to 5-year blood pressure change among adults in Jiangsu, China: a cross-sectional study 
Nutrition Journal  2014;13:98.
Data relating to the association between tea consumption and blood pressure change are inconsistent. The aim of this analysis was to investigate the association between tea consumption and the change in blood pressure (BP) in Chinese adults over a 5-year period.
Data from 1109 Chinese men (N= 472) and women (N= 637) who participated in the Jiangsu Nutrition Study (JIN) were analysed. BP was measured in 2002 and 2007. Tea (green, black and total tea) consumption was quantitatively assessed at the follow-up survey in 2007.
Total tea and green tea consumption were inversely associated with 5-year diastolic BP (DBP) but not systolic BP (SBP) change. In the multivariable analysis, compared with no consumption of tea, those with daily total tea/green tea consumption of at least10 g had 2.41 mmHg and 3.68 mmHg smaller increase of DBP respectively. There was a significant interaction between smoking and total tea/green tea consumption and DBP change. The inverse association between total tea/green tea consumption and DBP change was significant only in non-smokers. Green tea consumption was inversely associated with SBP change only in non-smokers and those without central obesity.
The consumption of green tea is inversely associated with 5-year BP change among Chinese adults, an effect abrogated by smoking.
Electronic supplementary material
The online version of this article (doi:10.1186/1475-2891-13-98) contains supplementary material, which is available to authorized users.
PMCID: PMC4209085  PMID: 25311544
Blood pressure change; Tea consumption; Epidemiology; Nutrition; Population study
10.  A Controlled Trial of Bupropion Added to Nicotine Patch and Behavioral Therapy for Smoking Cessation in Adults with Unipolar Depressive Disorders 
Although there is a strong relationship between depression and smoking, most nicotine dependence treatment trials exclude depressed smokers. Our objective was to determine if bupropion improves abstinence rates and abstinence-associated depressive symptoms when added to transdermal nicotine replacement therapy (NRT) and group cognitive behavioral therapy (CBT) in smokers with unipolar depressive disorder (UDD). Adult smokers with current (n=90) or past (n=109) UDD were randomly assigned to receive bupropion or placebo added to NRT and CBT for 13 weeks. In the primary analysis, with dropouts considered smokers, 36% (35/97) of those on bupropion and 31% (32/102) on placebo attained biochemically-validated 7-day point-prevalence abstinence at end of treatment (NS). Because of a high drop out rate (50%) and a significant difference in abstinence status at dropout by treatment group, a traditional intent-to-treat (ITT) analysis with last observation carried forward imputation of abstinence status was performed. In this secondary analysis, 56% (54/97) of those on bupropion and 41% (42/102) on placebo met criteria for abstinence at end of trial, Chi2=4.18, p=0.04. NRT usage and absence of a co-morbid anxiety disorder predicted abstinence. Abstinence was associated with increased depressive symptoms, regardless of bupropion treatment. Thus, in the primary analysis, bupropion neither increased the efficacy of intensive group CBT and NRT for smoking cessation in smokers with UDD nor prevented abstinence-associated depressive symptoms. Bupropion appeared to provide an advantage for smoking cessation for those who remained in the trial. The dropout rate was high and was characterized by higher prevalence of current comorbid anxiety disorder. Given the high abstinence rate achieved with CBT plus NRT, a ceiling effect related to the high level of intervention received by all subjects may have prevented an adequate test of bupropion.
PMCID: PMC3505846  PMID: 19011435
Depression; Major Depressive Disorder; Unipolar Depressive Disorder; Nicotine; Smoking Cessation; Bupropion; Cognitive Behavioral Therapy; Nicotine Replacement Therapy; Relapse
11.  Smoking Cessation for Patients With Chronic Obstructive Pulmonary Disease (COPD) 
Executive Summary
In July 2010, the Medical Advisory Secretariat (MAS) began work on a Chronic Obstructive Pulmonary Disease (COPD) evidentiary framework, an evidence-based review of the literature surrounding treatment strategies for patients with COPD. This project emerged from a request by the Health System Strategy Division of the Ministry of Health and Long-Term Care that MAS provide them with an evidentiary platform on the effectiveness and cost-effectiveness of COPD interventions.
After an initial review of health technology assessments and systematic reviews of COPD literature, and consultation with experts, MAS identified the following topics for analysis: vaccinations (influenza and pneumococcal), smoking cessation, multidisciplinary care, pulmonary rehabilitation, long-term oxygen therapy, noninvasive positive pressure ventilation for acute and chronic respiratory failure, hospital-at-home for acute exacerbations of COPD, and telehealth (including telemonitoring and telephone support). Evidence-based analyses were prepared for each of these topics. For each technology, an economic analysis was also completed where appropriate. In addition, a review of the qualitative literature on patient, caregiver, and provider perspectives on living and dying with COPD was conducted, as were reviews of the qualitative literature on each of the technologies included in these analyses.
The Chronic Obstructive Pulmonary Disease Mega-Analysis series is made up of the following reports, which can be publicly accessed at the MAS website at:
Chronic Obstructive Pulmonary Disease (COPD) Evidentiary Framework
Influenza and Pneumococcal Vaccinations for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Smoking Cessation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Community-Based Multidisciplinary Care for Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Long-term Oxygen Therapy for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Noninvasive Positive Pressure Ventilation for Acute Respiratory Failure Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Noninvasive Positive Pressure Ventilation for Chronic Respiratory Failure Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Hospital-at-Home Programs for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Home Telehealth for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Cost-Effectiveness of Interventions for Chronic Obstructive Pulmonary Disease Using an Ontario Policy Model
Experiences of Living and Dying With COPD: A Systematic Review and Synthesis of the Qualitative Empirical Literature
For more information on the qualitative review, please contact Mita Giacomini at: member_giacomini.htm.
For more information on the economic analysis, please visit the PATH website:
The Toronto Health Economics and Technology Assessment (THETA) collaborative has produced an associated report on patient preference for mechanical ventilation. For more information, please visit the THETA website:
The objective of this evidence-based analysis was to determine the effectiveness and cost-effectiveness of smoking cessation interventions in the management of chronic obstructive pulmonary disease (COPD).
Clinical Need: Condition and Target Population
Tobacco smoking is the main risk factor for COPD. It is estimated that 50% of older smokers develop COPD and more than 80% of COPD-associated morbidity is attributed to tobacco smoking. According to the Canadian Community Health Survey, 38.5% of Ontarians who smoke have COPD. In patients with a significant history of smoking, COPD is usually present with symptoms of progressive dyspnea (shortness of breath), cough, and sputum production. Patients with COPD who smoke have a particularly high level of nicotine dependence, and about 30.4% to 43% of patients with moderate to severe COPD continue to smoke. Despite the severe symptoms that COPD patients suffer, the majority of patients with COPD are unable to quit smoking on their own; each year only about 1% of smokers succeed in quitting on their own initiative.
Smoking cessation is the process of discontinuing the practice of inhaling a smoked substance. Smoking cessation can help to slow or halt the progression of COPD. Smoking cessation programs mainly target tobacco smoking, but may also encompass other substances that can be difficult to stop smoking due to the development of strong physical addictions or psychological dependencies resulting from their habitual use.
Smoking cessation strategies include both pharmacological and nonpharmacological (behavioural or psychosocial) approaches. The basic components of smoking cessation interventions include simple advice, written self-help materials, individual and group behavioural support, telephone quit lines, nicotine replacement therapy (NRT), and antidepressants. As nicotine addiction is a chronic, relapsing condition that usually requires several attempts to overcome, cessation support is often tailored to individual needs, while recognizing that in general, the more intensive the support, the greater the chance of success. Success at quitting smoking decreases in relation to:
a lack of motivation to quit,
a history of smoking more than a pack of cigarettes a day for more than 10 years,
a lack of social support, such as from family and friends, and
the presence of mental health disorders (such as depression).
Research Question
What are the effectiveness and cost-effectiveness of smoking cessation interventions compared with usual care for patients with COPD?
Research Methods
Literature Search
Search Strategy
A literature search was performed on June 24, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations (1950 to June Week 3 2010), EMBASE (1980 to 2010 Week 24), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Cochrane Library, and the Centre for Reviews and Dissemination for studies published between 1950 and June 2010. A single reviewer reviewed the abstracts and obtained full-text articles for those studies meeting the eligibility criteria. Reference lists were also examined for any additional relevant studies not identified through the search. Data were extracted using a standardized data abstraction form.
Inclusion Criteria
English-language, full reports from 1950 to week 3 of June, 2010;
either randomized controlled trials (RCTs), systematic reviews and meta-analyses, or non-RCTs with controls;
a proven diagnosis of COPD;
adult patients (≥ 18 years);
a smoking cessation intervention that comprised at least one of the treatment arms;
≥ 6 months’ abstinence as an outcome; and
patients followed for ≥ 6 months.
Exclusion Criteria
case reports
case series
Outcomes of Interest
≥ 6 months’ abstinence
Quality of Evidence
The quality of each included study was assessed taking into consideration allocation concealment, randomization, blinding, power/sample size, withdrawals/dropouts, and intention-to-treat analyses.
The quality of the body of evidence was assessed as high, moderate, low, or very low according to the GRADE Working Group criteria. The following definitions of quality were used in grading the quality of the evidence:
Summary of Findings
Nine RCTs were identified from the literature search. The sample sizes ranged from 74 to 5,887 participants. A total of 8,291 participants were included in the nine studies. The mean age of the patients in the studies ranged from 54 to 64 years. The majority of studies used the Global Initiative for Chronic Obstructive Lung Disease (GOLD) COPD staging criteria to stage the disease in study subjects. Studies included patients with mild COPD (2 studies), mild-moderate COPD (3 studies), moderate–severe COPD (1 study) and severe–very severe COPD (1 study). One study included persons at risk of COPD in addition to those with mild, moderate, or severe COPD, and 1 study did not define the stages of COPD. The individual quality of the studies was high. Smoking cessation interventions varied across studies and included counselling or pharmacotherapy or a combination of both. Two studies were delivered in a hospital setting, whereas the remaining 7 studies were delivered in an outpatient setting. All studies reported a usual care group or a placebo-controlled group (for the drug-only trials). The follow-up periods ranged from 6 months to 5 years. Due to excessive clinical heterogeneity in the interventions, studies were first grouped into categories of similar interventions; statistical pooling was subsequently performed, where appropriate. When possible, pooled estimates using relative risks for abstinence rates with 95% confidence intervals were calculated. The remaining studies were reported separately.
Abstinence Rates
Table ES1 provides a summary of the pooled estimates for abstinence, at longest follow-up, from the trials included in this review. It also shows the respective GRADE qualities of evidence.
Summary of Results*
Abbreviations: CI, confidence interval; NRT, nicotine replacement therapy.
Statistically significant (P < 0.05).
One trial used in this comparison had 2 treatment arms each examining a different antidepressant.
Based on a moderate quality of evidence, compared with usual care, abstinence rates are significantly higher in COPD patients receiving intensive counselling or a combination of intensive counselling and NRT.
Based on limited and moderate quality of evidence, abstinence rates are significantly higher in COPD patients receiving NRT compared with placebo.
Based on a moderate quality of evidence, abstinence rates are significantly higher in COPD patients receiving the antidepressant bupropion compared to placebo.
PMCID: PMC3384371  PMID: 23074432
12.  Injectable, sustained-release naltrexone for the treatment of opioid dependence: a randomized, placebo-controlled trial 
Archives of general psychiatry  2006;63(2):210-218.
Naltrexone is a medication available in oral form that can completely block the effects produced by opioid agonists, such as heroin. However, poor medication compliance with naltrexone has been a major obstacle to the effective treatment of opioid dependence.
To evaluate the safety and efficacy of a sustained-release depot formulation of naltrexone in treating opioid dependence.
Design, Setting, and Participants
Randomized, double-blind, placebo-controlled, 8-week multi-center trial of male and female heroin-dependent patients who participated in the study between September 2000 and November 2003. Participants were stratified by years of heroin use (≥5, <4.9) and gender, and then randomized to receive one of three doses: placebo, 192 mg, or 384 mg depot naltrexone. Doses were administered at the beginning of Week 1 and then again four weeks later at the beginning of Week 5. All participants received twice-weekly relapse prevention therapy, provided observed urine samples, and completed other assessments at each visit.
Main Outcome Measures
Primary outcome measures were retention in treatment and percentage of opioid-negative urine samples.
A total of 60 patients were randomized at two centers. Retention in treatment was dose related with 39%, 60%, and 68% of the patients in the placebo, naltrexone 192 mg, and naltrexone 384 mg groups, respectively, remaining in treatment at the end of the two-month treatment period. Analysis of the time to dropout revealed a significant main effect of dose with mean time to dropout of 27, 36, and 48 days, respectively, for the placebo, naltrexone 192 mg, and naltrexone 384 mg groups. The percentage of urine samples negative for opioids varied significantly as a function of dose, as did the percentage of urine samples negative for methadone, cocaine, benzodiazepines, and amphetamine. The percentage of urine samples negative for cannabinoids was not significantly different across groups. When the data were recalculated without the assumption that missing urine samples were positive, however, a main effect of group was not found for any of the drugs tested with the exception of cocaine, where the percentage of cocaine-negative urines was lower in the placebo group. Adverse events were minimal and generally mild in severity. This sustained-release formulation of naltrexone was well tolerated and produced a robust and dose-related increase in treatment retention.
The present data provide exciting new evidence for the feasibility, efficacy, and tolerability of long-lasting antagonist treatments for opioid dependence.
PMCID: PMC4200530  PMID: 16461865
13.  Adherence in Internet Interventions for Anxiety and Depression: Systematic Review 
Open access websites which deliver cognitive and behavioral interventions for anxiety and depression are characterised by poor adherence. We need to understand more about adherence in order to maximize the impact of Internet-based interventions on the disease burden associated with common mental disorders.
The aims of this paper are to review briefly the adherence literature with respect to Internet interventions and to investigate the rates of dropout and compliance in randomized controlled trials of anxiety and depression Web studies.
A systematic review of randomized controlled trials using Internet interventions for anxiety and depression was conducted, and data was collected on dropout and adherence, predictors of adherence, and reasons for dropout.
Relative to reported rates of dropout from open access sites, the present study found that the rates of attrition in randomized controlled trials were lower, ranging from approximately 1 - 50%. Predictors of adherence included disease severity, treatment length, and chronicity. Very few studies formally examined reasons for dropout, and most studies failed to use appropriate statistical techniques to analyze missing data.
Dropout rates from randomized controlled trials of Web interventions are low relative to dropout from open access websites. The development of theoretical models of adherence is as important in the area of Internet intervention research as it is in the behavioral health literature. Disease-based factors in anxiety and depression need further investigation.
PMCID: PMC2762797  PMID: 19403466
Patient dropouts; depression; depressive disorder, major; anxiety disorders; Internet; mental health services; treatment outcome
14.  Differences in Reach and Attrition Between Web-Based and Print-Delivered Tailored Interventions Among Adults over 50 Years of Age: Clustered Randomized Trial 
The Internet has the potential to provide large populations with individual health promotion advice at a relatively low cost. Despite the high rates of Internet access, actual reach by Web-based interventions is often disappointingly low, and differences in use between demographic subgroups are present. Furthermore, Web-based interventions often have to deal with high rates of attrition.
This study aims to assess user characteristics related to participation and attrition when comparing Web-based and print-delivered tailored interventions containing similar content and thereby to provide recommendations in choosing the appropriate delivery mode for a particular target audience.
We studied the distribution of a Web-based and a print-delivered version of the Active Plus intervention in a clustered randomized controlled trial (RCT). Participants were recruited via direct mailing within the participating Municipal Health Council regions and randomized to the printed or Web-based intervention by their region. Based on the answers given in a prior assessment, participants received tailored advice on 3 occasions: (1) within 2 weeks after the baseline, (2) 2 months after the baseline, and (3) within 4 months after the baseline (based on a second assessment at 3 months). The baseline (printed or Web-based) results were analyzed using ANOVA and chi-square tests to establish the differences in user characteristics between both intervention groups. We used logistic regression analyses to study the interaction between the user characteristics and the delivery mode in the prediction of dropout rate within the intervention period.
The printed intervention resulted in a higher participation rate (19%) than the Web-based intervention (12%). Participants of the Web-based intervention were significantly younger (P<.001), more often men (P=.01), had a higher body mass index (BMI) (P=.001) and a lower intention to be physically active (P=.03) than participants of the printed intervention. The dropout rate was significantly higher in the Web-based intervention group (53%) compared to the print-delivered intervention (39%, P<.001). A low intention to be physically active was a strong predictor for dropout within both delivery modes (P<.001). The difference in dropout rate between the Web-based and the printed intervention was not explained by user characteristics.
The reach of the same tailored physical activity (PA) intervention in a printed or Web-based delivery mode differed between sociodemographic subgroups of participants over 50 years of age. Although the reach of the Web-based intervention is lower, Web-based interventions can be a good channel to reach high-risk populations (lower PA intention and higher BMI). While the dropout rate was significantly higher in the Web-based intervention group, no specific user characteristics explained the difference in dropout rates between the delivery modes. More research is needed to determine what caused the high rate of dropout in the Web-based intervention.
Trial Registration
Dutch Trial Register (NTR): 2297: (Archived by WebCite at
PMCID: PMC3803160  PMID: 23246790
Web-based; print-delivered; physical activity; older adults; response; reach; adoption; attrition; dropout; tailored advice
15.  Dropout, Nonusage Attrition, and Pretreatment Predictors of Nonusage Attrition in a Commercial Web-Based Weight Loss Program 
An understanding of the factors that predict retention and website use are critical to the development of effective Web-based weight loss interventions. However, poor retention (dropout attrition) and website utilization (nonusage attrition) are major inhibitors to the effectiveness of Web-based programs.
The study aimed to (1) describe the prevalence of dropout and nonusage attrition and (2) examine pretreatment predictors of nonusage attrition in a cohort of commercial Web-based weight loss program participants.
Participants enrolled in the online program, The Biggest Loser Club, Australia, from August 15, 2007, to May 31, 2008. Only those who subscribed for 12 or 52 weeks were included in this study. All data were collected by the program proprietors, SP Health Co Pty Ltd (Sydney, Australia), and provided in “deidentified” form. Data collected included responses to a pretreatment survey (sociodemographic and behavioral characteristics), subscription history (date of enrollment and subscription end), and website use (log-ins, food and exercise diary entries, weigh-ins, and forum posts). Participants were classified as a member of the program at 12 or 52 weeks if they held an active subscription plan at that point in time. Participants were classified as nonusers at 12 or 52 weeks if they had stopped using all of the website features and had not returned. Predictors of nonusage attrition were explored using Cox proportional hazards regression analysis.
Of the 9599 eligible participants, 6943 (72%) subscribed to the program for 12 weeks, and 2656 (28%) subscribed for 52 weeks. Of all participants, 31% (2975/9599) were classified as overweight, 61% (5866/9599) were classified as obese, 86% (8279/9599) were female, and participants’ mean (SD) age was 35.7 (9.5) years. The 12 week and 52 week subscribers’ retention rates were 97% and 77% respectively. Of 12 week subscribers, 35% were classified as program “users” after 12 weeks, and 30% of 52 week subscribers were classified as “users” after 52 weeks. Significant predictors of nonusage attrition among 12 week subscribers included age (hazard ratio for 45 to 55 years of age = 0.83, 95% confidence interval [CI] 0.73 - 0.93, P = .001; hazard ratio for 55 to 65 years of age = 0.80, 95% CI 0.66 - 0.99, P = .04), exercise level (hazard ratio = 0.76, 95% CI 0.72 - 0.81, P < .001), emotional eating (hazard ratio = 1.11, 95% CI 1.04 - 1.18, P = .001), eating breakfast (hazard ratio = 0.88, 95% CI 0.82 - 0.95, P = .001), and skipping meals (hazard ratio = 1.12, 95% CI 1.04 -1.19, P = .001). For 52 week subscribers, eating breakfast (hazard ratio = 0.88, 95% CI 0.79 - 0.99, P = .04) and not drinking tea or coffee with sugar (hazard ratio = 1.23, 95% CI 1.11 - 1.37, P < .001) were the pretreatment characteristics that significantly decreased risk of nonusage attrition.
The findings demonstrate a high prevalence of nonusage attrition among a cohort of commercial Web-based weight loss program participants. Several sociodemographic and behavioral factors were shown to independently predict nonusage attrition.
PMCID: PMC3056525  PMID: 21156470
Weight loss; Internet; commercial sector; retention
16.  Methods to Analyze Treatment Effects in the Presence of Missing Data for a Continuous Heavy Drinking Outcome Measure when Participants Drop Out from Treatment in Alcohol Clinical Trials 
Attrition is common in alcohol clinical trials and the resultant loss of data represents an important methodological problem. In the absence of a simulation study, the drinking outcomes among those who are lost to follow-up are not known. Individuals who drop out of treatment and continue to provide drinking data, however, may be a reasonable proxy group for making inferences about the drinking outcomes of those lost to follow-up.
We used data from the COMBINE study, a multisite, randomized clinical trial, to examine drinking during the four months of treatment among individuals who dropped out of treatment but continued to provide drinking data (i.e., “treatment dropouts;” n=185). First, we estimated the observed treatment effect size for naltrexone versus placebo in a sample that included both treatment completers (n=961) and treatment dropouts (n=185; total N=1146), as well as the observed treatment effect size among just those who dropped out of treatment (n=185). In both the total sample (N=1146) and the dropout sample (n=185), we then deleted the drinking data after treatment dropout from those 185 individuals to simulate missing data. Using the deleted datasets we then estimated the effect of naltrexone on the continuous outcome percent heavy drinking days using six methods to handle missing data (last observation carried forward, baseline observation carried forward, placebo mean imputation, missing=heavy drinking days, multiple imputation (MI), and full information maximum likelihood (FIML)).
MI and FIML produced effect size estimates that were most similar to the true effects observed in the full data set in all analyses, while missing=heavy drinking days performed the worst.
Although missing drinking data should be avoided whenever possible, MI and FIML yield the best estimates of the treatment effect for a continuous outcome measure of heavy drinking when there is dropout in an alcohol clinical trial.
PMCID: PMC4244651  PMID: 25421518
missing data; alcohol use disorder; relapse; treatment; clinical trials; continuous outcome measure
17.  Medical School Attrition-Beyond the Statistics A Ten Year Retrospective Study 
BMC Medical Education  2013;13:13.
Medical school attrition is important - securing a place in medical school is difficult and a high attrition rate can affect the academic reputation of a medical school and staff morale. More important, however, are the personal consequences of dropout for the student. The aims of our study were to examine factors associated with attrition over a ten-year period (2001–2011) and to study the personal effects of dropout on individual students.
The study included quantitative analysis of completed cohorts and qualitative analysis of ten-year data. Data were collected from individual student files, examination and admission records, exit interviews and staff interviews. Statistical analysis was carried out on five successive completed cohorts. Qualitative data from student files was transcribed and independently analysed by three authors. Data was coded and categorized and key themes were identified.
Overall attrition rate was 5.7% (45/779) in 6 completed cohorts when students who transferred to other medical courses were excluded. Students from Kuwait and United Arab Emirates had the highest dropout rate (RR = 5.70, 95% Confidence Intervals 2.65 to 12.27;p < 0.0001) compared to Irish and EU students combined. North American students had a higher dropout rate than Irish and EU students; RR = 2.68 (1.09 to 6.58;p = 0.027) but this was not significant when transfers were excluded (RR = 1.32(0.38, 4.62);p = 0.75). Male students were more likely to dropout than females (RR 1.70, .93 to 3.11) but this was not significant (p = 0.079).
Absenteeism was documented in 30% of students, academic difficulty in 55.7%, social isolation in 20%, and psychological morbidity in 40% (higher than other studies). Qualitative analysis revealed recurrent themes of isolation, failure, and despair. Student Welfare services were only accessed by one-third of dropout students.
While dropout is often multifactorial, certain red flag signals may alert us to risk of dropout including non-EU origin, academic struggling, absenteeism, social isolation, depression and leave of absence. Psychological morbidity amongst dropout students is high and Student Welfare services should be actively promoted. Absenteeism should prompt early intervention. Behind every dropout statistic lies a personal story. All medical schools have a duty of care to support students who leave the medical programme.
PMCID: PMC3565981  PMID: 23363547
Medical school attrition; Dropout; Exit interviews; Student welfare services; Academic difficulty; Absenteeism
18.  Participant recruitment and retention in a pilot program to prevent weight gain in low-income overweight and obese mothers 
BMC Public Health  2009;9:424.
Recruitment and retention are key functions for programs promoting nutrition and other lifestyle behavioral changes in low-income populations. This paper describes strategies for recruitment and retention and presents predictors of early (two-month post intervention) and late (eight-month post intervention) dropout (non retention) and overall retention among young, low-income overweight and obese mothers participating in a community-based randomized pilot trial called Mothers In Motion.
Low-income overweight and obese African American and white mothers ages 18 to 34 were recruited from the Special Supplemental Nutrition Program for Women, Infants, and Children in southern Michigan. Participants (n = 129) were randomly assigned to an intervention (n = 64) or control (n = 65) group according to a stratification procedure to equalize representation in two racial groups (African American and white) and three body mass index categories (25.0-29.9 kg/m2, 30.0-34.9 kg/m2, and 35.0-39.9 kg/m2). The 10-week theory-based culturally sensitive intervention focused on healthy eating, physical activity, and stress management messages that were delivered via an interactive DVD and reinforced by five peer-support group teleconferences. Forward stepwise multiple logistic regression was performed to examine whether dietary fat, fruit and vegetable intake behaviors, physical activity, perceived stress, positive and negative affect, depression, and race predicted dropout as data were collected two-month and eight-month after the active intervention phase.
Trained personnel were successful in recruiting subjects. Increased level of depression was a predictor of early dropout (odds ratio = 1.04; 95% CI = 1.00, 1.08; p = 0.03). Greater stress predicted late dropout (odds ratio = 0.20; 95% CI = 0.00, 0.37; p = 0.01). Dietary fat, fruit, and vegetable intake behaviors, physical activity, positive and negative affect, and race were not associated with either early or late dropout. Less negative affect was a marginal predictor of participant retention (odds ratio = 0.57; 95% CI = 0.31, 1.03; p = 0.06).
Dropout rates in this study were higher for participants who reported higher levels of depression and stress.
Trial registration
Current Controlled Trials NCT00944060
PMCID: PMC2785793  PMID: 19930587
19.  Effect of green tea on reward learning in healthy individuals: a randomized, double-blind, placebo-controlled pilot study 
Nutrition Journal  2013;12:84.
Both clinical and preclinical studies revealed that regular intake of green tea reduced the prevalence of depressive symptoms, as well as produced antidepressant-like effects in rodents. Evidence proposed that disturbed reward learning has been associated with the development of anhedonia, a core symptom of depression. However, the relationship between green tea and reward learning is poorly investigated. Our goal was to test whether chronic treatment with green tea in healthy subjects affects the process of reward learning and subsequently regulates the depressive symptoms.
Seventy-four healthy subjects participated in a double-blind, randomized placebo-controlled study with oral administration of green tea or placebo for 5weeks. We used the monetary incentive delay task to evaluate the reward learning by measurement of the response to reward trial or no-reward trial. We compared the reaction time of reward responsiveness between green tea and placebo treatment. Furthermore, we selected Montgomery-Asberg depression rating scale (MADRS) and 17-item Hamilton Rating Scale for Depression (HRSD-17) to estimate the depressive symptoms in these two groups.
The results showed chronic treatment of green tea increased reward learning compared with placebo by decreasing the reaction time in monetary incentive delay task. Moreover, participants treated with green tea showed reduced scores measured in MADRS and HRSD-17 compared with participants treated with placebo.
Our findings reveal that chronic green tea increased the reward learning and prevented the depressive symptoms. These results also raised the possibility that supplementary administration of green tea might reverse the development of depression through normalization of the reward function.
PMCID: PMC3702504  PMID: 23777561
Green tea; Depression; Reward learning; Anhedonia
20.  A Standardized Transcutaneous Electric Acupoint Stimulation for Relieving Tobacco Urges in Dependent Smokers 
The efficacy of acupuncture in smoking cessation, and its effect on the urge to smoke are unclear. We evaluated the effect of a standardized protocol of transcutaneous electric acupoint stimulations (TEAS) on alleviating the urge to smoke. Ninety-eight smokers were recruited in two double-blind studies. Participants abstained from smoking for 26 h, and were randomized to receive TEAS alternating between 2 and 100 Hz at four acupoints (LI4 and PC8, PC6 and TE5) at four different intensities (10, 5, Intermittent 5 or 0 mA). The urge to smoke was assessed by the Questionnaire of Smoking Urges (QSU-Brief). In Experiment 1, the 10 mA group (n = 20) was compared with the 5 mA group (n = 20); the increase in smoking urges did not differ significantly. Considering the possibility that 5 mA may be an active intervention, in Experiment 2, a true placebo (0 mA), and a proxy of placebo [Intermittent 5 mA (i5 mA)] were compared with 10 mA TEAS. In this experiment, 10 mA (n = 20) TEAS showed a tendency to alleviate smoking urges compared with 0 mA (n = 16), and i5 mA (n = 19) TEAS. Only when the data of smokers with Fagerstöm Test for Nicotine Dependence score ≥5 were analyzed that the difference between the 10 mA group and the control group (0 and i5 mA) became significant. Based on these preliminary findings, we conclude that TEAS applied on the skin may antagonize the increase in urge to smoke in abstinent-dependent smokers. It seems warranted to assess the efficacy of TEAS in smoking cessation clinical trials involving a larger population of dependent smokers.
PMCID: PMC3135870  PMID: 19073777
21.  Early dropout predictive factors in obesity treatment 
Diet attrition and failure of long term treatment are very frequent in obese patients. This study aimed to identify pre-treatment variables determining dropout and to customise the characteristics of those most likely to abandon the program before treatment, thus making it possible to modify the therapy to increase compliance. A total of 146 outpatients were consecutively enrolled; 73 patients followed a prescriptive diet while 73 followed a novel brief group Cognitive Behavioural Treatment (CBT) in addition to prescriptive diet. The two interventions lasted for six months. Anthropometric, demographic, psychological parameters and feeding behaviour were assessed, the last two with the Italian instrument VCAO Ansisa; than, a semi-structured interview was performed on motivation to lose weight. To identify the baseline dropout risk factors among these parameters, univariate and multivariate logistic models were used. Comparison of the results in the two different treatments showed a higher attrition rate in CBT group, despite no statistically significant difference between the two treatment arms (P = 0.127). Dropout patients did not differ significantly from those who did not dropout with regards to sex, age, Body Mass Index (BMI), history of cycling, education, work and marriage. Regardless of weight loss, the most important factor that determines the dropout appears to be a high level of stress revealed by General Health Questionnaire-28 items (GHQ-28) score within VCAO test. The identification of hindering factors during the assessment is fundamental to reduce the dropout risk. For subjects at risk, it would be useful to dedicate a stress management program before beginning a dietary restriction.
PMCID: PMC3944162  PMID: 24611111
Obesity treatment; weight loss; diet attrition; dropout risk factor; dropout predictive factor
22.  Identifying Risk for Attrition during Treatment for Depression 
Psychotherapy and Psychosomatics  2009;78(6):372-379.
Understanding patients’ ambivalence about treatment persistence may be useful in tailoring retention interventions for individual patients with major depressive disorder.
Participants (n = 265) with major depressive disorder were enrolled into an 8-week trial with a selective serotonin reuptake inhibitor. At baseline and week 2, the participants were asked about their intent to return for the next visit, complete the study and continue in the study should they experience side effects or no improvement. Dropouts were defined as participants who discontinued attending clinic visits before completing the trial.
Participants who at baseline reported an uncertain/negative intent to continue if they experienced side effects or no improvement dropped out at a significantly higher rate by weeks 6 and 8. Uncertain/negative intent at week 2 predicted attrition at all following visits. Dropouts without side effects were more likely to have reported an uncertain/negative intent to attend at both baseline and week 2, while dropouts who experienced side effects were more likely to have reported an uncertain/negative intent to attend only at baseline. Positive intent to continue was associated with greater symptom improvement in both dropouts and completers despite the possibility of lack of efficacy.
Participants’ pretreatment concerns about continuing antidepressant treatment in the presence of side effects signals challenges to the completion of a full 8-week acute phase treatment, even if the participant does not develop side effects. Individualized review of concerns and tailoring appropriate interventions may be necessary to reduce attrition.
PMCID: PMC2820313  PMID: 19738403
Attrition; Adherence; Depression; Antidepressant; Attitudes
23.  Feasibility and Effectiveness of a Web-Based Positive Psychology Program for Youth Mental Health: Randomized Controlled Trial 
Youth mental health is a significant public health concern due to the high prevalence of mental health problems in this population and the low rate of those affected seeking help. While it is increasingly recognized that prevention is better than cure, most youth prevention programs have utilized interventions based on clinical treatments (eg, cognitive behavioral therapy) with inconsistent results.
This study explores the feasibility of the online delivery of a youth positive psychology program, Bite Back, to improve the well-being and mental health outcomes of Australian youth. Further aims were to examine rates of adherence and attrition, and to investigate the program’s acceptability.
Participants (N=235) aged 12-18 years were randomly assigned to either of two conditions: Bite Back (n=120) or control websites (n=115). The Bite Back website comprised interactive exercises and information across a variety of positive psychology domains; the control condition was assigned to neutral entertainment-based websites that contained no psychology information. Participants in both groups were instructed to use their allocated website for 6 consecutive weeks. Participants were assessed pre- and postintervention on the Depression Anxiety Stress Scale-Short form (DASS-21) and the Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS).
Of the 235 randomized participants, 154 (65.5%) completed baseline and post measures after 6 weeks. Completers and dropouts were equivalent in demographics, the SWEMWBS, and the depression and anxiety subscales of the DASS-21, but dropouts reported significantly higher levels of stress than completers. There were no differences between the Bite Back and control conditions at baseline on demographic variables, DASS-21, or SWEMWBS scores. Qualitative data indicated that 49 of 61 Bite Back users (79%) reported positive experiences using the website and 55 (89%) agreed they would continue to use it after study completion. Compared to the control condition, participants in the Bite Back condition with high levels of adherence (usage of the website for 30 minutes or more per week) reported significant decreases in depression and stress and improvements in well-being. Bite Back users who visited the site more frequently (≥3 times per week) reported significant decreases in depression and anxiety and improvements in well-being. No significant improvements were found among Bite Back users who demonstrated low levels of adherence or who used the website less frequently.
Results suggest that using an online positive psychology program can decrease symptoms of psychopathology and increase well-being in young people, especially for those who use the website for 30 minutes or longer per week or more frequently (≥3 times per week). Acceptability of the Bite Back website was high. These findings are encouraging and suggest that the online delivery of positive psychology programs may be an alternate way to address mental health issues and improve youth well-being nationally.
Trial Registration
Australian New Zealand Clinical Trials Registry: ACTRN1261200057831; (Archived by Webcite at
PMCID: PMC4071231  PMID: 24901900
adolescent; resilience; psychological; mental health; Internet; early medical intervention
24.  Opioid use and dropout in patients receiving oral naltrexone with or without single administration of injection naltrexone 
Drug and alcohol dependence  2014;147:122-129.
Adherence to oral naltrexone has been poor and can be improved somewhat with behavioral therapy. We compared Behavioral Naltrexone Therapy (BNT) to Compliance Enhancement (CE) and tested efficacy of single-dose injection naltrexone (XR-NTX; 384 mg) with behavioral therapies at further improving aherence to oral naltrexone.
A 24-week, randomized, placebo-controlled trial (N=125) compared four treatment conditions following inpatient detoxification and oral naltrexone induction: (1) BNT+XR-NTX; (2) BNT+ placebo injection; (3) CE+ XR-NTX; and (4) CE+placebo injection. All participants were maintained on oral naltrexone throughout the trial. Primary outcome was retention in treatment.
Of 89 randomized participants, 78.7% (70/89) completed 4 weeks, 58.2% (54/89) completed 8 weeks, 47.2% (42/89) completed 12 weeks, and 25.8% (23/89) completed 24 weeks. A Cox proportional hazards regression modeled time to dropout as a function of treatment condition, baseline opioid dependence severity (bags per day of heroin use), and their interaction. Interaction of conditions by baseline severity was significant (X23 = 9.19, p = .027). For low-severity patients (<6 bags/day), retention was highest in the BNT-XRNTX group (60% at 6 months), as hypothesized. For high-severity (> 6 bags/day) patients, BNT-XR-NTX did not perform as well, due to high early attrition.
For low-severity heroin users, single-dose XR-NTX improved long-term treatment retention when combined with behavioral therapy. In higher-severity opioid-dependent patients, XR-NTX was less helpful, perhaps because, combined with oral naltrexone, it produced higher blood levels and more withdrawal discomfort. When cost considerations recommend oral naltrexone following XR-NTX, the latter should be phased in slowly.
PMCID: PMC4435949  PMID: 25555621
Opiate dependence treatment; Pharmacotherapy trials; Injection naltrexone; oral naltrexone; Opioid antagonist
25.  Meta-analysis of Dropout in Treatments for Post-traumatic Stress Disorder 
Many patients dropout of treatments for Post-traumatic stress disorder (PTSD) and some clinicians believe that ‘trauma focused’ treatments increase dropout.
We conducted a meta-analysis of dropout among active treatments in clinical trials for PTSD (42 studies; 17 direct comparisons).
The average dropout rate was 18%, but it varied significantly across studies. Group modality and greater number of sessions, but not trauma focus, predicted increased dropout. When the meta-analysis was restricted to direct comparisons of active treatments, there were no differences in dropout. Differences in trauma focus between treatments in the same study did not predict dropout. However, trauma focused treatments resulted in higher dropout as compared to Present Centered Therapy (PCT) – a treatment originally designed as a control, but now listed as a research supported intervention for PTSD.
Dropout varies between active interventions for PTSD across studies, but differences are primarily driven by differences between studies. There do not appear to be systematic differences across active interventions when they are directly compared in the same study. The degree of clinical attention placed on the traumatic event does not appear to be a primary cause of dropout from active treatments. However comparisons of PCT may be an exception to this general pattern, perhaps due to a restriction of variability in trauma focus among comparisons of active treatments. More research is needed comparing trauma focused interventions to trauma avoidant treatments such as PCT.
PMCID: PMC3893277  PMID: 23339535

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