Project Direct: Pilot Study of A Collaborative Intervention for Depressed Seniors

2008 ◽  
Vol 27 (2) ◽  
pp. 201-218 ◽  
Author(s):  
Jane McCusker ◽  
Martin Cole ◽  
Mark Yaffe ◽  
Philippe Cappeliez ◽  
Martin Dawes ◽  
...  
Keyword(s):  
Pilot Study ◽  
Controlled Trial ◽  
Evidence Based ◽  
Depression Care ◽  
Screening Process ◽  
Problem Solving Therapy ◽  
Family Doctors ◽  
Randomized Controlled ◽  
Collaborative Intervention

This pilot study assessed the feasibility of a randomized controlled trial of an intervention for major depression among seniors in Canadian family practice. The intervention involved care by a family physician augmented by a Depression Care Practitioner, the latter working under the supervision of a psychiatrist. Treatments included family doctors' prescriptions of antidepressants according to an evidence-based study algorithm and/or brief problem-solving therapy. Eligible patients aged 60+ were identified in a 2-step screening process: 68 patients from 29 Montreal family practices were randomized, and 66 completed the 2-month follow-up. Results support the feasibility of a multisite trial of this intervention.

scholarly journals Effectiveness of Village Health Worker–Delivered Smoking Cessation Counseling in Vietnam

2018 ◽  
Vol 21 (11) ◽  
pp. 1524-1530 ◽  
Author(s):  
Nan Jiang ◽  
Nina Siman ◽  
Charles M Cleland ◽  
Nancy Van Devanter ◽  
Trang Nguyen ◽  
...  
Keyword(s):  
Primary Care ◽  
Health Care ◽  
Controlled Trial ◽  
Evidence Based ◽  
Care Providers ◽  
Water Pipe ◽  
Randomized Controlled ◽  
Provider Advice ◽  
Village Health

Abstract Introduction Smoking prevalence is high in Vietnam, yet tobacco dependence treatment (TDT) is not widely available. Methods We conducted a quasiexperimental study that compared the effectiveness of health care provider advice and assistance (ARM 1) versus ARM 1 plus village health worker (VHW) counseling (ARM 2) on abstinence at 6-month follow-up. This study was embedded in a larger two-arm cluster randomized controlled trial conducted in 26 community health centers (CHCs) in Vietnam. Subjects (N = 1318) were adult patients who visited any participating CHC during the parent randomized controlled trial intervention period and were self-identified as current tobacco users (cigarettes and/or water pipe). Results At 6-month follow-up, abstinences rates in ARM 2 were significantly higher than those in ARM 1 (25.7% vs. 10.5%; p < .001). In multivariate analyses, smokers in ARM 2 were almost three times more likely to quit compared with those in ARM 1 (adjusted odds ratio [AOR] = 2.96, 95% confidence interval [CI] = 1.78% to 4.92%). Compared to cigarette-only smokers, water pipe–only smokers (AOR = 0.4, 95% CI = 0.26% to 0.62%) and dual users (AOR = 0.62, 95% CI = 0.45% to 0.86%) were less likely to achieve abstinence; however, the addition of VHW counseling (ARM 2) was associated with higher quit rates compared with ARM 1 alone for all smoker types. Conclusion A team approach in TDT programs that offer a referral system for health care providers to refer smokers to VHW-led cessation counseling is a promising and potentially scalable model for increasing access to evidence-based TDT and increasing quit rates in low middle-income countries (LMICs). TDT programs may need to adapt interventions to improve outcomes for water pipe users. Implications The study fills literature gaps on effective models for TDT in LMICs. The addition of VHW-led cessation counseling, available through a referral from primary care providers in CHCs in Vietnam, to health care provider’s brief cessation advice, increased 6-month biochemically validated abstinence rates compared to provider advice alone. The study also demonstrated the potential effectiveness of VHW counseling on reducing water pipe use. For LMICs, TDT programs in primary care settings with a referral system to VHW-led cessation counseling might be a promising and potentially scalable model for increasing access to evidence-based treatment.

Bayesian methods for pilot studies

2020 ◽  
Vol 17 (4) ◽  
pp. 414-419 ◽  
Author(s):  
Andrew R Willan ◽  
Lehana Thabane
Keyword(s):  
Randomized Controlled Trial ◽  
Pilot Study ◽  
Bayesian Methods ◽  
Controlled Trial ◽  
Recruitment Strategies ◽  
Pilot Studies ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Study Results

Background/aims: The use of pilot studies to help inform the design of randomized controlled trials has increased significantly over the last couple of decades. A pilot study can provide estimates of feasibility parameters, such as the recruitment, compliance and follow-up probabilities. The use of frequentist confidence intervals of these estimates fails to provide a meaningful measure of the uncertainty as it pertains to the design of the associated randomized controlled trial. The objective of this article is to introduce Bayesian methods for the analysis of pilot studies for determining the feasibility of an associated randomized controlled trial. Methods: An example from the literature is used to illustrate the advantages of a Bayesian approach for accounting for the uncertainty in pilot study results when assessing the feasibility of an associated randomized controlled trial. Vague beta distribution priors for the feasibility parameters are used. Based on the results from a feasibility study, simulation methods are used to determine the expected power of specified recruitment strategies for an associated randomized controlled trial. Results: The vague priors used for the feasibility parameters are demonstrated to be considerably robust. Beta distribution posteriors for the feasibility parameters lead to beta-binomial predictive distributions for an associated randomized controlled trial regarding the number of patients randomized, the number of patients who are compliant and the number of patients who complete follow-up. Ignoring the uncertainty in pilot study results can lead to inadequate power for an associated randomized controlled trial. Conclusion: Applying Bayesian methods to pilot studies’ results provides direct inference about the feasibility parameters and quantifies the uncertainty regarding the feasibility of an associated randomized controlled trial in an intuitive and meaningful way. Furthermore, Bayesian methods can identify recruitment strategies that yield the desired power for an associated randomized controlled trial.

scholarly journals Long-term Efficacy of Percutaneous Epidural Neurolysis of Adhesions in Chronic Lumbar Radicular Pain: 10 Year Follow-up of a Randomized Controlled Trial

2021 ◽  
pp. 359-367
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Radicular Pain ◽  
Feasibility Trial ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Patient Factor ◽  
One Year

BACKGROUND: No long-term follow-up data exist in any treatment for chronic radicular pain occurring with disc pathology and after failed back surgery. A previous randomized controlled trial (RCT) has proven efficacy in short-term follow-up as an evidence-based effective therapeutic option. OBJECTIVES: Long term data is needed to determine the efficacy and cost- effectiveness of minimal invasive procedures. The present study reports 10 year follow-up results from the randomized trial. STUDY DESIGN: A prospective, randomized, placebo-controlled, interventional clinical trial. A power calculation was based on a previous feasibility trial. SETTING: University medical centers. METHODS: After a 4 year enrollment phase, 381 patients with chronic radicular pain persisting beyond 4 months, who failed conservative treatments, were screened. Ninety patients were enrolled. Patients were randomly assigned to receive percutaneous epidural lysis of adhesions or placebo with concealed allocation in permuted blocks of 4 to 8 patients each, and stratified by treatment center. The primary outcomes were a mean change of the Oswestry Disability Index (ODI) scores and Visual Analog Scale (VAS), one and 10 years after intervention. For each rating scale an analysis of variance with the within-patient factor time (baseline, one year follow-up, 10 year follow-up) and the between-patient factor treatment (lysis, placebo) was used. RESULTS: Homogeneity was shown at baseline between the groups. The ODI and VAS scores were significantly better one and 10 years in the lysis group vs the control group. The ODI in the lysis group improved from 55.3 ± 11.6 to 9.6 ± 9.3 after one year and to 11.7 ± 14.2 after 10 years. The placebo group also improved from 55.4 ± 11.5 to 30.7 ± 14.2 after one year and to 24.8 ± 12.0 after 10 years. The VAS improved from 6.7 ± 1.1 to 1.2 ± 1.1 after one year and to 1.5 ± 1.4 after 10 years in the lysis group and from 6.7 ± 1.1 to 2.8 ± 1.5 after one year and to 2.9 ± 1.3 after 10 years after placebo intervention. The statistical difference of the ODI and VAS between the treatment and control groups remain significant up to 10 years. No treatment-related severe adverse effects occurred within the 10 years, but minor transient neurological effects were seen directly after the intervention. LIMITATIONS: The long-term effects of single treatment components cannot be specified as no imaging examination was performed at 10 year follow-up. A large variety of unanalyzed noninvasive treatments were done within the 10 years. Some patients did not clearly remember the intervention after 10 years. Uncontrolled effects such as higher inhomogeneity of biometric properties, concomitant therapies, pain tolerance level, or just social effects could occur, but were not analyzed in the trial. CONCLUSION: This is the first 10 year follow-up report of a placebo-controlled RCT showing efficacy of the minimally invasive percutaneous adhesiolysis procedure for patients with chronic lumbosacral radicular pain. No alternative evidence-based treatment modality with 10 year follow-up is available to be recommended. This procedure should be considered as the first treatment option for patients with chronic lumbosacral radicular pain. KEY WORDS: Disc herniation, RCT, disc disease, radiculopathy, back pain, failed back syndrome, epidural, lysis of adhesions, adhesiolysis

scholarly journals Effectiveness of Dialectical Behavioral Therapy on Reduction of Recidivism Among Recently Incarcerated Homeless Women: A Pilot Study

2018 ◽  
Vol 62 (15) ◽  
pp. 4796-4813 ◽  
Author(s):  
Adeline Nyamathi ◽  
Sanghyuk S. Shin ◽  
Jolene Smeltzer ◽  
Benissa Salem ◽  
Kartik Yadav ◽  
...  
Keyword(s):  
Health Promotion ◽  
Pilot Study ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Homeless Women ◽  
Dialectical Behavioral Therapy ◽  
Randomized Controlled ◽  
Reducing Recidivism ◽  
Pilot Randomized Controlled Trial

The purpose of this pilot randomized controlled trial (RCT) was to compare the 6-month outcomes of a Dialectical Behavioral Therapy–Corrections Modified (DBT-CM) program versus a Health Promotion (HP) program on mitigating recidivism among 130 female parolees/probationers between baseline and 6-month follow-up. The effect of DBT-CM on reducing recidivism was greater among those who expressed a desire for help (risk ratio [RR] = 0.40; 95% confidence interval [CI] = [0.16, 1.00]; p = .050) and among homeless female ex-offenders (HFOs) who were younger (<50 years of age; RR = 0.46; 95% CI = [0.19, 1.11]; p = .085) and participants with Desire for Help score > 35 (Model 3; RR = 0.40; 95% CI = [0.16, 1.00]; p = .050). Findings from this pilot study suggest that the DBT-CM intervention may be effective in reducing reincarceration rates among some HFOs during reentry. Larger RCTs are needed to validate our findings.

scholarly journals The impact of a digital wheeze detector on parental disease management of pre-school children suffering from wheezing—a pilot study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Stephanie Dramburg ◽  
Ellen Dellbrügger ◽  
Wim van Aalderen ◽  
Paolo Maria Matricardi
Keyword(s):  
Randomized Controlled Trial ◽  
Pilot Study ◽  
Airway Obstruction ◽  
Controlled Trial ◽  
Electronic Diary ◽  
Asthma Control Test ◽  
Randomized Controlled ◽  
Airway Infections ◽  
The Impact

Abstract Background Viral airway infections are a major reason for doctor’s visits at pre-school age, especially when associated with wheezing. While proper treatment requires adequate recognition of airway obstruction, caretakers are often struggling with this judgment, consequently leading to insufficient or late treatment and an unnecessary discomfort of the patient. Digital technologies may serve to support parental decision taking. The aim of the present pilot study is to acquire data on the feasibility of recruitment and observation procedures for a randomized controlled trial on the impact of a digital wheeze detector in a home management setting of pre-school wheezing. Methods This single-armed pilot study enrolled patients with a doctor’s diagnosis of wheezing aged 9 to 72 months. Participants were asked to use a digital wheeze detector (WheezeScan, Omron Healthcare, Japan) 2×/day for 30 days and record the child’s respiratory symptoms, detection of wheezing, and medication intake via an electronic diary (eDiary) app. Demographic and clinical data were collected at the recruitment visit. The asthma control test and the Parent Asthma Management Self-Efficacy Scale (PAMSES) were assessed both, at recruitment and follow-up. Results Twenty families were recruited and completed the monitoring. All but one completed the follow-up after 30 days. The recruitment procedures were feasible, and adherence to daily monitoring reached an average of 81%. The use of the wheeze detector was rated as uncomplicated. Parents detected wheezing without digital support in only 22/708 (3.1%) of the recorded events. By contrast, the wheeze detector indicated an airway obstruction in 140/708 (19.8%) of the recordings. Conclusion In parallel to feasible recruitment procedures, we observed good usability of the wheeze detection device and high adherence to eDiary recording. The positive outcomes show that the WheezeScan may empower parents by increasing their capacity for wheeze detection. This deserves to be investigated in a larger randomized controlled trial.

scholarly journals Compassion-Focused Intervention for Highly Self-Critical Individuals: Pilot Study

2018 ◽  
Vol 46 (5) ◽  
pp. 583-600 ◽  
Author(s):  
Alexandra Rose ◽  
Ruth McIntyre ◽  
Katharine A. Rimes
Keyword(s):  
Pilot Study ◽  
Treatment Approach ◽  
Controlled Trial ◽  
Self Esteem ◽  
Preliminary Evidence ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Weekly Treatment ◽  
Compassion Focused Therapy

Self-criticism is a transdiagnostic process associated with a range of psychological problems. This uncontrolled pilot study evaluated the feasibility and acceptability of a six-session intervention using methods from compassion-focused therapy to reduce self-criticism, as well as investigating changes in a range of outcome measures. Twenty-three university student participants with significant impaired functioning associated with high levels of self-criticism received six individual weekly treatment sessions and a 2-month follow-up appointment. Acceptability was assessed through participant feedback. The intervention appeared to be feasible in terms of recruitment and retention of participants, and participant feedback indicated that overall the intervention seemed acceptable. There were statistically significant improvements between pre- and post-intervention for self-criticism, functional impairment, mood, self-esteem and maladaptive perfectionism with medium to large effect sizes at both post-intervention and follow-up. Gains were maintained or increased between post-treatment and 2-month follow-up. The study showed preliminary evidence of effectiveness of a compassion-focused intervention for self-critical students which appeared to be a feasible and acceptable treatment approach. This intervention now requires investigation in a randomized controlled trial.

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