Specialized Rheumatology Nurse Substitutes for Rheumatologists in the Diagnostic Process of Fibromyalgia: A Cost-Consequence Analysis and a Randomized Controlled Trial

2011 ◽  
Vol 38 (7) ◽  
pp. 1413-1422 ◽  
Author(s):  
MARIËLLE E. KROESE ◽  
JOHAN L. SEVERENS ◽  
GUY J. SCHULPEN ◽  
MONIQUE C. BESSEMS ◽  
FRANS J. NIJHUIS ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Health Status ◽  
Societal Perspective ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Diagnostic Process ◽  
Societal Costs ◽  
Consequence Analysis ◽  
Randomized Controlled ◽  
Cost Consequence

Objective.To perform a cost-consequence analysis of the substitution of specialized rheumatology nurses (SRN) for rheumatologists (RMT) in the diagnostic process of fibromyalgia (FM), using both a healthcare and societal perspective and a 9-month period.Methods.Alongside a randomized controlled trial, we measured costs and consequences of a nurse-led diagnostic consult (SRN group, n = 97) versus a rheumatologist-led diagnostic consult [usual care (UC) group, n = 96]. Patients were followed for 9 months. Every second month a questionnaire on medical consumption and social participation was filled out. Satisfaction was measured 1 week after the first consultation. During followup, health status was measured by health-related quality of life (EQ-5D), functional status (Fibromyalgia Impact Questionnaire), fatigue (Checklist Individual Strength), and self-efficacy (Generalized Self-Efficacy Scale).Results.Patients in the SRN group were significantly more satisfied. Improvements in health status were similar in both groups after 9 months of followup. Total costs for healthcare consumption and patient and family costs were significantly lower in the SRN group (€1298 vs €1644; difference €346; 95% CI –€746 to –€2). Total societal costs were €3853 per patient for the SRN group and €5293 for the UC group after 9 months of followup (difference €1440; 95% CI –€3721 to €577).Conclusion.From both a healthcare and societal perspective, the nurse-led diagnostic process can be recommended. Patients in the SRN group were significantly more satisfied, improvements in health status were similar in both groups, and total societal costs were lower for the SRN group compared to the RMT group after 9 months’ followup. Registered with Current Controlled Trials, no.ISRCTN77212411.

An Exploration of the Effectiveness of the Fun For Wellness Online Intervention to Promote Health in Adults With Obesity: A Randomized Controlled Trial

2020 ◽  
pp. 263207702096873
Author(s):  
Isaac Prilleltensky ◽  
Adam McMahon ◽  
Nicholas D. Myers ◽  
Ora Prilleltensky ◽  
Samantha Dietz ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Health Status ◽  
Self Efficacy ◽  
Large Scale ◽  
Controlled Trial ◽  
Well Being ◽  
The United States ◽  
Double Blind ◽  
Randomized Controlled ◽  
Positive Direct

Fun For Wellness (FFW) is an online behavioral intervention developed to promote well-being by enhancing the self-efficacy of participants. The objective of this study was to evaluate the effectiveness of FFW to promote health in adults with obesity in the United States in a relatively uncontrolled setting. The study design was a large-scale, prospective, double-blind, parallel group randomized controlled trial. Data collection occurred at three time points: baseline, 30 days, and 60 days after baseline. There was evidence for a positive direct effect of FFW on physical health status ([Formula: see text] = 1.33, p = .005, d = 0.24) at 60 days after baseline. In addition, there was evidence of a positive indirect effect of FFW on mental health status at 60 days after baseline through psychological well-being self-efficacy ([Formula: see text] = 0.44, [0.05, 0.94]).

scholarly journals An Internet-Based Cognitive Behavioral Program for Adolescents With Anxiety: Pilot Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Kathleen O'Connor ◽  
Alexa Bagnell ◽  
Patrick McGrath ◽  
Lori Wozney ◽  
Ashley Radomski ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Retention Rates ◽  
Control Group ◽  
Consequence Analysis ◽  
Randomized Controlled ◽  
Cost Consequence

BACKGROUND Internet-based cognitive behavioral therapy (ICBT) is a treatment approach recently developed and studied to provide frontline treatment to adolescents with anxiety disorders. OBJECTIVE This study aimed to pilot procedures and obtain data on methodological processes and intervention satisfaction to determine the feasibility of a definitive randomized controlled trial (RCT) to test the effectiveness of a self-managed ICBT program, Breathe (Being Real, Easing Anxiety: Tools Helping Electronically), for adolescents with anxiety concerns. METHODS This study employed a two-arm, multisite, pilot RCT. Adolescents aged 13 to 17 years with a self-identified anxiety concern were recruited online from health care settings and school-based mental health care services across Canada between April 2014 and May 2016. We compared 8 weeks of ICBT with ad hoc telephone and email support (Breathe experimental group) to access to a static webpage listing anxiety resources (control group). The primary outcome was the change in self-reported anxiety from baseline to 8 weeks (posttreatment), which was used to determine the sample size for a definitive RCT. Secondary outcomes were recruitment and retention rates, a minimal clinically important difference (MCID) for the primary outcome, intervention acceptability and satisfaction, use of cointerventions, and health care resource use, including a cost-consequence analysis. RESULTS Of the 588 adolescents screened, 94 were eligible and enrolled in the study (49 adolescents were allocated to Breathe and 45 were allocated to the control group). Analysis was based on 74% (70/94) of adolescents who completed baseline measures and progressed through the study. Enrolled adolescents were, on average, 15.3 years old (SD 1.2) and female (63/70, 90%). Retention rates at 8 weeks were 28% (13/46; Breathe group) and 58% (24/43; control group). Overall, 39% (14/36) of adolescents provided feedback on completion of the Breathe program. Adolescents’ scores on a satisfaction survey indicated a moderate level of satisfaction. All but one adolescent indicated that Breathe was easy to use and they understood all the material presented. The most frequent barrier identified for program completion was difficulty in completing exposure activities. The power analysis indicated that 177 adolescents per group would be needed to detect a medium effect size (<i>d</i>=0.3) between groups in a definitive trial. Data for calculating an MCID or conducting a cost-consequence analysis were insufficient due to a low response rate at 8 weeks. CONCLUSIONS Adolescents were moderately satisfied with Breathe. However, program adjustments will be needed to address attrition and reduce perceived barriers to completing key aspects of the program. A definitive RCT to evaluate the effectiveness of the program is feasible if protocol adjustments are made to improve recruitment and retention to ensure timely study completion and increase the completeness of the data at each outcome measurement time point. CLINICALTRIAL ClinicalTrials.gov NCT02059226; http://clinicaltrials.gov/ct2/show/NCT02059226.

scholarly journals An Internet-Based Cognitive Behavioral Program for Adolescents With Anxiety: Pilot Randomized Controlled Trial

10.2196/13356 ◽  
2020 ◽  
Vol 7 (7) ◽  
pp. e13356
Author(s):  
Kathleen O'Connor ◽  
Alexa Bagnell ◽  
Patrick McGrath ◽  
Lori Wozney ◽  
Ashley Radomski ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Retention Rates ◽  
Control Group ◽  
Consequence Analysis ◽  
Randomized Controlled ◽  
Cost Consequence

Background Internet-based cognitive behavioral therapy (ICBT) is a treatment approach recently developed and studied to provide frontline treatment to adolescents with anxiety disorders. Objective This study aimed to pilot procedures and obtain data on methodological processes and intervention satisfaction to determine the feasibility of a definitive randomized controlled trial (RCT) to test the effectiveness of a self-managed ICBT program, Breathe (Being Real, Easing Anxiety: Tools Helping Electronically), for adolescents with anxiety concerns. Methods This study employed a two-arm, multisite, pilot RCT. Adolescents aged 13 to 17 years with a self-identified anxiety concern were recruited online from health care settings and school-based mental health care services across Canada between April 2014 and May 2016. We compared 8 weeks of ICBT with ad hoc telephone and email support (Breathe experimental group) to access to a static webpage listing anxiety resources (control group). The primary outcome was the change in self-reported anxiety from baseline to 8 weeks (posttreatment), which was used to determine the sample size for a definitive RCT. Secondary outcomes were recruitment and retention rates, a minimal clinically important difference (MCID) for the primary outcome, intervention acceptability and satisfaction, use of cointerventions, and health care resource use, including a cost-consequence analysis. Results Of the 588 adolescents screened, 94 were eligible and enrolled in the study (49 adolescents were allocated to Breathe and 45 were allocated to the control group). Analysis was based on 74% (70/94) of adolescents who completed baseline measures and progressed through the study. Enrolled adolescents were, on average, 15.3 years old (SD 1.2) and female (63/70, 90%). Retention rates at 8 weeks were 28% (13/46; Breathe group) and 58% (24/43; control group). Overall, 39% (14/36) of adolescents provided feedback on completion of the Breathe program. Adolescents’ scores on a satisfaction survey indicated a moderate level of satisfaction. All but one adolescent indicated that Breathe was easy to use and they understood all the material presented. The most frequent barrier identified for program completion was difficulty in completing exposure activities. The power analysis indicated that 177 adolescents per group would be needed to detect a medium effect size (d=0.3) between groups in a definitive trial. Data for calculating an MCID or conducting a cost-consequence analysis were insufficient due to a low response rate at 8 weeks. Conclusions Adolescents were moderately satisfied with Breathe. However, program adjustments will be needed to address attrition and reduce perceived barriers to completing key aspects of the program. A definitive RCT to evaluate the effectiveness of the program is feasible if protocol adjustments are made to improve recruitment and retention to ensure timely study completion and increase the completeness of the data at each outcome measurement time point. Trial Registration ClinicalTrials.gov NCT02059226; http://clinicaltrials.gov/ct2/show/NCT02059226.

scholarly journals Neurocognitive and Self-efficacy Benefits of Cognitive Remediation in Schizophrenia: A Randomized Controlled Trial – Corrigendum

2019 ◽  
Vol 25 (6) ◽  
pp. 659-660
Author(s):  
Shayden D. Bryce ◽  
Susan L. Rossell ◽  
Stuart J. Lee ◽  
Richard J. Lawrence ◽  
Eric J. Tan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Cognitive Remediation ◽  
Randomized Controlled
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