scholarly journals A multisite randomized controlled trial of two group education programs for fatigue in multiple sclerosis: Very long term (5–6 year) follow-up at one site

2021 ◽  
Vol 7 (4) ◽  
pp. 205521732110544
Author(s):  
Julia Norton ◽  
Sandra Joos ◽  
Michelle H Cameron ◽  
Cinda L Hugos
Keyword(s):  
Controlled Trial ◽  
Management Program ◽  
Self Management ◽  
Behavior Changes ◽  
Similar Frequency ◽  
Impact Scale ◽  
Fatigue Impact Scale ◽  
And Behavior

Background A multicomponent group MS fatigue self-management program reduced fatigue impact compared to a rigorous control 12 months after enrollment. Objectives Assess and compare changes between groups in fatigue impact and behavior changes implemented 5–6 years after enrollment. Methods The Modified Fatigue Impact Scale (MFIS) and a behavior change questionnaire were administered 5–6 years after enrollment. Results There were no significant changes in mean MFIS scores within or between groups from baseline to 5–6 years later. Behavior changes were of similar frequency in both groups. Conclusion Fatigue impact was stable and behavior changes were similar between groups 5–6 years after a fatigue self-management program.

A multicenter randomized controlled trial of two group education programs for fatigue in multiple sclerosis: Long-term (12-month) follow-up at one site

2018 ◽  
Vol 25 (6) ◽  
pp. 871-875 ◽  
Author(s):  
Cinda L Hugos ◽  
Michelle H Cameron ◽  
Zunqiu Chen ◽  
Yiyi Chen ◽  
Dennis Bourdette
Keyword(s):  
Controlled Trial ◽  
Control Program ◽  
Group Program ◽  
Delayed Effect ◽  
Randomized Controlled ◽  
Impact Scale ◽  
Multicenter Randomized Controlled Trial ◽  
Fatigue Impact Scale

Background: A four-site RCT of Fatigue: Take Control (FTC), a multicomponent group program, found no significant differences from a control program, MS: Take Control (MSTC), in fatigue on the Modified Fatigue Impact Scale (MFIS) through 6 months. Objective: Assess FTC for a delayed effect on fatigue. Methods: Of 78 subjects at one site, 74 randomized to FTC or MSTC completed the MFIS at 12 months. Results: Compared to baseline, FTC produced greater improvements in MFIS scores than MSTC (FTC −8.9 (confidence interval (CI): 32.2, 45), MSTC −2.5 (CI 39.6, 47.7), p = 0.03) at 12 months. Conclusion: The delayed effect of FTC on fatigue suggests the need for longer follow-up when assessing interventions for fatigue.

scholarly journals Effects of a Mindfulness-Based Intervention versus Health Self-Management on Subclinical Anxiety in Older Adults with Subjective Cognitive Decline: The SCD-Well Randomized Superiority Trial

2021 ◽  
pp. 1-10
Author(s):  
Natalie L. Marchant ◽  
Thorsten Barnhofer ◽  
Roxane Coueron ◽  
Miranka Wirth ◽  
Antoine Lutz ◽  
...  
Keyword(s):  
Older Adults ◽  
Cognitive Decline ◽  
State Anxiety ◽  
Controlled Trial ◽  
Management Program ◽  
Anxiety Symptoms ◽  
Self Management ◽  
Subjective Cognitive Decline ◽  
Depression Symptoms

<b><i>Introduction:</i></b> Older adults experiencing subjective cognitive decline (SCD) have a heightened risk of developing dementia and frequently experience subclinical anxiety, which is itself associated with dementia risk. <b><i>Objective:</i></b> To understand whether subclinical anxiety symptoms in SCD can be reduced through behavioral interventions. <b><i>Methods:</i></b> SCD-Well is a randomized controlled trial designed to determine whether an 8-week mindfulness-based intervention (caring mindfulness-based approach for seniors; CMBAS) is superior to a structurally matched health self-management program (HSMP) in reducing subclinical anxiety. Participants were recruited from memory clinics at 4 European sites. The primary outcome was change in anxiety symptoms (trait subscale of the State-Trait Anxiety Inventory; trait-STAI) from pre- to postintervention. Secondary outcomes included a change in state anxiety and depression symptoms postintervention and 6 months postrandomization (follow-up). <b><i>Results:</i></b> One hundred forty-seven participants (mean [SD] age: 72.7 [6.9] years; 64.6% women; CMBAS, <i>n</i> = 73; HSMP, <i>n</i> = 74) were included in the intention-to-treat analysis. There was no difference in trait-STAI between groups postintervention (adjusted change difference: –1.25 points; 95% CI –4.76 to 2.25) or at follow-up (adjusted change difference: –0.43 points; 95% CI –2.92 to 2.07). Trait-STAI decreased postintervention in both groups (CMBAS: –3.43 points; 95% CI –5.27 to –1.59; HSMP: –2.29 points; 95% CI –4.14 to –0.44) and reductions were maintained at follow-up. No between-group differences were observed for change in state anxiety or depression symptoms. <b><i>Conclusions:</i></b> A time-limited mindfulness intervention is not superior to health self-management in reducing subclinical anxiety symptoms in SCD. The sustained reduction observed across both groups suggests that subclinical anxiety symptoms in SCD are modifiable. <b><i>ClinicalTrials.gov identifier:</i></b> NCT03005652.

scholarly journals The importance of maternal pregnancy vitamin D for offspring bone health: learnings from the MAVIDOS trial

2021 ◽  
Vol 13 ◽  
pp. 1759720X2110069
Author(s):  
Rebecca J. Moon ◽  
Elizabeth M. Curtis ◽  
Stephen J. Woolford ◽  
Shanze Ashai ◽  
Cyrus Cooper ◽  
...  
Keyword(s):  
Vitamin D ◽  
Bone Development ◽  
Controlled Trial ◽  
Clinical Care ◽  
Later Life ◽  
Vitamin D Supplementation ◽  
Public Health Policies ◽  
Positive Effects

Optimisation of skeletal mineralisation in childhood is important to reduce childhood fracture and the long-term risk of osteoporosis and fracture in later life. One approach to achieving this is antenatal vitamin D supplementation. The Maternal Vitamin D Osteoporosis Study is a randomised placebo-controlled trial, the aim of which was to assess the effect of antenatal vitamin D supplementation (1000 IU/day cholecalciferol) on offspring bone mass at birth. The study has since extended the follow up into childhood and diversified to assess demographic, lifestyle and genetic factors that determine the biochemical response to antenatal vitamin D supplementation, and to understand the mechanisms underpinning the effects of vitamin D supplementation on offspring bone development, including epigenetics. The demonstration of positive effects of maternal pregnancy vitamin D supplementation on offspring bone development and the delineation of underlying biological mechanisms inform clinical care and future public-health policies.

scholarly journals Nurse-based secondary preventive follow-up by telephone reduced recurrence of cardiovascular events: a randomised controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Anna-Lotta Irewall ◽  
Anders Ulvenstam ◽  
Anna Graipe ◽  
Joachim Ögren ◽  
Thomas Mooe
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Endpoint ◽  
Cardiovascular Events ◽  
Controlled Trial ◽  
Control Group ◽  
Coronary Syndrome ◽  
Secondary Endpoints ◽  
Randomised Controlled

AbstractEnhanced follow-up is needed to improve the results of secondary preventive care in patients with established cardiovascular disease. We examined the effect of long-term, nurse-based, secondary preventive follow-up by telephone on the recurrence of cardiovascular events. Open, randomised, controlled trial with two parallel groups. Between 1 January 2010 and 31 December 2014, consecutive patients (n = 1890) admitted to hospital due to stroke, transient ischaemic attack (TIA), or acute coronary syndrome (ACS) were included. Participants were randomised (1:1) to nurse-based telephone follow-up (intervention, n = 944) or usual care (control, n = 946) and followed until 31 December 2017. The primary endpoint was a composite of stroke, myocardial infarction, cardiac revascularisation, and cardiovascular death. The individual components of the primary endpoint, TIA, and all-cause mortality were analysed as secondary endpoints. The assessment of outcome events was blinded to study group assignment. After a mean follow-up of 4.5 years, 22.7% (n = 214) of patients in the intervention group and 27.1% (n = 256) in the control group reached the primary composite endpoint (HR 0.81, 95% CI 0.68–0.97; ARR 4.4%, 95% CI 0.5–8.3). Secondary endpoints did not differ significantly between groups. Nurse-based secondary preventive follow-up by telephone reduced the recurrence of cardiovascular events during long-term follow-up.

scholarly journals Long-term outcomes of two-stage, immediate and delayed breast reconstruction with polyurethane-covered versus textured implants: protocol of a prospective, multicentre randomised controlled trial (TIPI trial)

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e044219
Author(s):  
J X Harmeling ◽  
Kevin Peter Cinca ◽  
Eleni-Rosalina Andrinopoulou ◽  
Eveline M L Corten ◽  
M A Mureau
Keyword(s):  
Randomised Controlled Trial ◽  
Breast Reconstruction ◽  
Controlled Trial ◽  
Capsular Contracture ◽  
Tissue Expander ◽  
Complication Rates ◽  
Two Stage ◽  
Randomised Controlled

IntroductionTwo-stage implant-based breast reconstruction is the most commonly performed postmastectomy reconstructive technique. During the first stage, a tissue expander creates a sufficiently large pocket for the definite breast implant placed in the second stage. Capsular contracture is a common long-term complication associated with implant-based breast reconstruction, causing functional complaints and often requiring reoperation. The exact aetiology is still unknown, but a relationship between the outer surface of the implant and the probability of developing capsular contracture has been suggested. The purpose of this study is to determine whether polyurethane-covered implants result in a different capsular contracture rate than textured implants.Methods and analysisThe Textured Implants versus Polyurethane-covered Implants (TIPI) trial is a multicentre randomised controlled trial with a 1:1 allocation rate and a follow-up of 10 years. A total of 321 breasts of female adults undergoing a two-stage breast reconstruction will be enrolled. The primary outcome is capsular contracture at 10-year follow-up which is graded with the modified Baker classification. It is analysed with survival analysis using a frailty model for clustered interval-censored data, with both an intention-to-treat and per-protocol approach. Secondary outcomes are other complication rates, surgical revision rate, patient satisfaction and quality of life and user-friendliness. Outcomes are measured 2 weeks, 6 months, 1, 2, 3, 5 and 10 years postoperatively. Interim analysis is performed when 1-year, 3-year and 5-year follow-up is completed.Ethics and disseminationThe trial has been reviewed and approved by the Medical Research Ethics Committee of the Erasmus MC, University Medical Centre Rotterdam (MEC-2018-126) and locally by each participating centre. Written informed consent will be obtained from each study participant. The results will be disseminated by publication in peer-reviewed journals.Trial registrationNTR7265.

scholarly journals Randomized Controlled Trial of the Clinical Recovery and Biodegradation of Polylactide-co-glycolide Implants Used in the Intramedullary Nailing of Children’s Forearm Shaft Fractures with at Least Four Years of Follow-Up

2021 ◽  
Vol 10 (5) ◽  
pp. 995
Author(s):  
Marja Perhomaa ◽  
Tytti Pokka ◽  
Linda Korhonen ◽  
Antti Kyrö ◽  
Jaakko Niinimäki ◽  
...  
Keyword(s):  
Intramedullary Nailing ◽  
Controlled Trial ◽  
Long Term Outcomes ◽  
Intramedullary Nails ◽  
Metal Implants ◽  
Shaft Fractures ◽  
Fractures In Children ◽  
Significant Difference

The preferred surgical fixation of forearm shaft fractures in children is Elastic Stable Intramedullary Nailing (ESIN). Due to known disadvantageous effects of metal implants, a new surgical method using biodegradable polylactide-co-glycolide (PLGA) intramedullary nails has been developed but its long-term outcomes are unclear. The aim of this study was to compare the long-term outcomes of Biodegradable Intramedullary Nailing (BIN) to ESIN and assess the biodegradation of the study implants via magnetic resonance imaging (MRI). The study population of the prospective, randomized trial consisted of paediatric patients whose forearm shaft fractures were treated with BIN (n = 19) or ESIN (n = 16). Forearm rotation at minimally four years’ follow-up was the main outcome. There was no clinically significant difference in the recovery of the patients treated with the BIN as compared to those treated with the ESIN. More than half of the implants (57.7%, n = 15/26) were completely degraded, and the rest were degraded almost completely. The PLGA intramedullary nails used in the treatment of forearm shaft fractures in this study resulted in good function and anatomy. No unexpected disadvantages were found in the degradation of the implants. However, two implant failures had occurred in three months postoperatively.

Sign in / Sign up

Export Citation Format

Share Document