scholarly journals Beyond current research practice: Methodological considerations in MS rehabilitation research (is designing the perfect rehabilitation trial the Holy Grail or a Gordian knot?)

2019 ◽  
Vol 25 (10) ◽  
pp. 1337-1347
Author(s):  
Roshan das Nair ◽  
Vincent de Groot ◽  
Jennifer Freeman
Keyword(s):  
Primary Outcome ◽  
Critical Mass ◽  
Complex Interventions ◽  
Reporting Quality ◽  
Control Groups ◽  
Participant Selection ◽  
Methodological Considerations ◽  
Randomised Controlled ◽  
The Right

Rehabilitation is an essential aspect of symptomatic and supportive treatment for people with multiple sclerosis (MS). The number of randomised controlled trials (RCTs) for rehabilitation interventions in MS has increased over the last two decades. The design, conduct and reporting quality of some of these trials could be improved. There are, however, some specific challenges that researchers face in conducting RCTs of rehabilitation interventions, which are often ‘complex interventions’. This paper explores some of the challenges of undertaking robust clinical trials in rehabilitation. We focus on issues related to (1) participant selection and sample size, (2) interventions – the ‘dose’, content, active ingredients, targeting, fidelity of delivery and treatment adherence, (3) control groups and (4) outcomes – choosing the right type, number, timing of outcomes, and the importance of defining a primary outcome and clinically important difference between groups. We believe that by following internationally accepted RCT guidelines, by developing a critical mass of MS rehabilitation ‘trialists’ through international collaboration and by continuing to critique, challenge, and develop RCT designs, we can exploit the potential of RCTs to answer important questions related to the effectiveness of rehabilitation interventions.

scholarly journals Maintaining musculoskeletal health using a behavioural therapy approach: a population-based randomised controlled trial (the MAmMOTH Study)

2021 ◽  
pp. annrheumdis-2020-219091 ◽  
Author(s):  
Gary J Macfarlane ◽  
Marcus Beasley ◽  
Neil Scott ◽  
Huey Chong ◽  
Paul McNamee ◽  
...  
Keyword(s):  
Quality Of Life ◽  
High Risk ◽  
Primary Outcome ◽  
Population Based ◽  
Behavioural Therapy ◽  
Short Course ◽  
Life Years ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectiveCognitive–behavioural therapy (CBT) has been shown to be effective in the management of chronic widespread pain (CWP); we now test whether it can prevent onset among adults at high risk.MethodsA population-based randomised controlled prevention trial, with recruitment through UK general practices. A mailed screening questionnaire identified adults at high risk of CWP. Participants received either usual care (UC) or a short course of telephone CBT (tCBT). The primary outcome was CWP onset at 12 months assessed by mailed questionnaire. There were seven secondary outcomes including quality of life (EuroQol Questionnaire-five dimensions-five levels/EQ-5D-5L) used as part of a health economic assessment.Results996 participants were randomised and included in the intention-to-treat analysis of which 825 provided primary outcome data. The median age of participants was 59 years; 59% were women. At 12 months there was no difference in the onset of CWP (tCBT: 18.0% vs UC: 17.5%; OR 1.05; 95% CI 0.75 to 1.48). Participants who received tCBT were more likely to report better quality of life (EQ-5D-5L utility score mean difference 0.024 (95% CI 0.009 to 0.040)); and had 0.023 (95% CI 0.007 to 0.039) more quality-adjusted life-years at an additional cost of £42.30 (95% CI −£451.19 to £597.90), yielding an incremental cost-effectiveness ratio of £1828. Most secondary outcomes showed significant benefit for the intervention.ConclusionsA short course of tCBT did not prevent onset of CWP in adults at high risk, but improved quality of life and was cost-effective. A low-cost, short-duration intervention benefits persons at risk of CWP.Trial registration numberClinicalTrials.gov Registry (NCT02668003).

A Tablet ‐ Based Intervention for Activating Nursing Home Residents with Dementia: Results from a Cluster-Randomised Controlled Trial

2020 ◽  
Author(s):  
Julie Lorraine O'Sullivan ◽  
Sonia Lech ◽  
Paul Gellert ◽  
Ulrike Grittner ◽  
Jan-Niklas Voigt-Antons ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Nursing Home ◽  
Nursing Homes ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Nursing Home Residents ◽  
Cluster Randomised Controlled Trial ◽  
Post Intervention ◽  
Randomised Controlled

Abstract Background: Non-pharmacological interventions (NPI) can improve cognitive and non-cognitive symptoms in nursing home residents living with dementia. However, delivery of suitable NPI can be challenging in everyday nursing home settings. Internet and communication technologies (ICT) may be promising tools for supporting NPI delivery in nursing homes. Methods: A two-arm cluster-randomised controlled trial was conducted to investigate global and momentary effects of a novel ICT-based NPI for nursing home residents with dementia. Ten nursing homes were randomly allocated to the tablet-based intervention (TBI) or conventional activity sessions (CAS) group (each with five nursing homes) between April 2016 and May 2017. A total of N = 162 participants received either regular TBI (n = 80) or CAS (n = 82) over a period of eight weeks. Linear mixed models were used to analyse group differences regarding the primary outcome apathy (AES-I), and secondary outcomes quality of life (QOL-AD, QUALIDEM), neuropsychiatric (NPI-NH, psychotropic medication) and depressive symptoms (GDS). Ecological Momentary Assessments (EMA) of quality of life were also conducted in both groups before and after each activity session.Results: No significant group difference in the change of apathy (AES-I score, primary outcome) was found post intervention (mean group difference: B = .19; 95% CI: -3.90 to 4.28, p = .93). Regarding secondary outcomes, a reduction of psychotropic medication was found for TBI compared to CAS (B = .42; 95% CI: .15 to .69, p < .01). Further analyses revealed a post-intervention improvement of informant-rated quality of life across both groups (B = 3.69; 95% CI: .68 to 6.69, p = .02). Analysis of EMA also rendered short-term post-session improvements of quality of life in the CAS group (B = .43; 95% CI: .30 to .57, p < .001). Conclusions: These findings suggest that NPI involving individually tailored activities have a beneficial impact on quality of life in nursing home residents with dementia. Although we found no clear advantage of TBI compared to CAS, ICT have the potential to support NPI delivery and facilitate regular assessments of fluctuating momentary states in nursing home residents with dementia. Trial registration: The trial was retrospectively registered with the ISRCTN registry (Trial registration number: ISRCTN98947160) on 01/09/2016 http://www.isrctn.com/ISRCTN98947160.

scholarly journals Evaluation of a positive psychotherapy group intervention for people with psychosis: pilot randomised controlled trial

2015 ◽  
Vol 25 (3) ◽  
pp. 235-246 ◽  
Author(s):  
Beate Schrank ◽  
Tamsin Brownell ◽  
Zivile Jakaite ◽  
Charley Larkin ◽  
Francesca Pesola ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Group Intervention ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Self Esteem ◽  
Positive Psychotherapy ◽  
Main Effect ◽  
Randomised Controlled

Aims.Third-wave psychological interventions have gained relevance in mental health service provision but their application to people with psychosis is in its infancy and interventions targeting wellbeing in psychosis are scarce. This study tested the feasibility and preliminary effectiveness of positive psychotherapy adapted for people with psychosis (WELLFOCUS PPT) to improve wellbeing.Methods.WELLFOCUS PPT was tested as an 11-week group intervention in a convenience sample of people with psychosis in a single centre randomised controlled trial (ISRCTN04199273) involving 94 people with psychosis. Patients were individually randomised in blocks to receive either WELLFOCUS PPT in addition to treatment as usual (TAU), or TAU only. Assessments took place before randomisation and after the therapy. The primary outcome was wellbeing (Warwick-Edinburgh Mental Well-Being Scale, WEMWBS). Secondary outcomes included symptoms (Brief Psychiatric Rating Scale), depression (Short Depression-Happiness Scale), self-esteem, empowerment, hope, sense of coherence, savouring beliefs and functioning, as well as two alternative measures of wellbeing (the Positive Psychotherapy Inventory and Quality of Life). Intention-to-treat analysis was performed. This involved calculating crude changes and paired-sample t-tests for all variables, as well as ANCOVA and Complier Average Causal Effect (CACE) Analysis to estimate the main effect of group on all outcomes.Results.The intervention and trial procedures proved feasible and well accepted. Crude changes between baseline and follow-up showed a significant improvement in the intervention group for wellbeing according to all three concepts assessed (i.e., WEMWBS, Positive Psychotherapy Inventory and Quality of Life), as well as for symptoms, depression, hope, self-esteem and sense of coherence. No significant changes were observed in the control group. ANCOVA showed no main effect on wellbeing according to the primary outcome scale (WEMWBS) but significant effects on symptoms (p = 0.006, ES = 0.42), depression (p = 0.03, ES = 0.38) and wellbeing according to the Positive Psychotherapy Inventory (p = 0.02, ES = 0.30). Secondary analysis adapting for therapy group further improved the results for symptom reduction (p = 0.004, ES = 0.43) and depression (p = 0.03, ES = 0.41) but did not lead to any more outcomes falling below the p = 0.05 significance level. CACE analysis showed a non-significant positive association between the intervention and WEMWBS scores at follow-up (b = 0.21, z = 0.9, p = 0.4).Conclusions.This study provides initial evidence on the feasibility of WELLFOCUS PPT in people with psychosis, positively affecting symptoms and depression. However, more work is needed to optimise its effectiveness. Future research might evaluate positive psychotherapy as a treatment for comorbid depression in psychosis, and consider alternative measurements of wellbeing.

scholarly journals Reporting quality of chronic kidney disease practice guidelines according to the RIGHT statement: a systematic analysis

2020 ◽  
Vol 11 ◽  
pp. 204062232092201
Author(s):  
Yang Zhao ◽  
Yanyan Li ◽  
Junwei Li ◽  
Weijuan Song ◽  
Jun Zhao ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Practice Guidelines ◽  
Reporting Quality ◽  
Basic Information ◽  
Average Quality ◽  
Systematic Analysis ◽  
Other Information ◽  
The Right

Aim: The aim of this study was to evaluate the reporting quality of chronic kidney disease (CKD) guidelines. Methods: PubMed, EMBASE, and guideline-related websites were searched from 2008 to 2019. The CKD guidelines were included. Two reviewers used the RIGHT (Reporting Items for Practice Guidelines in Healthcare) checklist to assess the quality of guidelines and calculate the reporting proportion of each guideline. Results: We included 13 guidelines, of which 30.8% (4/13) were developed in Europe and about two-thirds (8/13) were published on their own website. The average quality of the 13 guidelines was 68.57%. The reporting proportion of the seven domains (i.e. basic information; background; evidence; recommendations; review and quality assurance; funding and declaration and management of interests; other information) were 65.39%, 81.73%, 63.08%, 69.23%, 53.85%, 63.46%, and 61.54%, respectively. Conclusion: CKD guidelines had moderate reporting quality in some domains, but guideline developers should increase the reporting items in basic information, guideline evidence, and recommendations. The RIGHT checklist would be a useful tool to improve the reporting quality of guidelines.

scholarly journals Quality of reporting for randomised clinical trials published in Latin American and Spanish journals: A protocol for a systematic survey of three clinical specialities

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e036148
Author(s):  
Vivienne C Bachelet ◽  
Víctor A Carrasco ◽  
Fabiana Bravo-Córdova ◽  
Ruben A Díaz ◽  
Francisca J Lizana ◽  
...  
Keyword(s):  
Latin American ◽  
Reporting Quality ◽  
Quality Of Reporting ◽  
Systematic Survey ◽  
Secondary Analyses ◽  
Randomised Controlled ◽  
Changes Over Time ◽  
The Impact ◽  
Internal And External Validity

IntroductionQuality of reporting refers to how published articles communicate how the research was done and what was found. Gaps and imprecisions of reporting hamper the assessment of the methodological quality and internal and external validity. The CONsolidated Standards of Reporting Trials (CONSORT) are a set of evidence-based recommendations of the minimum elements to be included in the reporting of randomised controlled trials (RCTs) to ensure a complete and transparent account of what was done, how it was done and what was found. Few studies have been conducted on the impact of CONSORT on RCTs published in Latin American and Spanish journals. We aim to assess the reporting quality of RCTs of three clinical specialities published in Spanish and Latin American journals, as well as to assess changes over time and associations of quality with journal and country indicators.Methods and analysisWe will conduct a systematic survey of all RCTs published in Spanish-language journals in three clinical fields (dentistry, neurology and geriatrics) from 1990 to 2018. We will include RCTs from previous work that has identified all RCTs on these medical fields published in Spain and Latin America. We will update this work via handsearching of relevant journals. Assessment of quality of reporting will be conducted independently and in duplicate using the CONSORT 2010 Statement. We will also extract journal and country indicators. We will conduct descriptive statistics and secondary analyses considering the year, country, and journal of publication, among others.Ethics and disseminationThe Universidad de Santiago de Chile’s ethics committee approved the protocol. We will disseminate the results of this work in peer-reviewed scientific journals and conference proceedings. We expect to raise awareness among researchers, journal editors and funders on the importance of training in reporting guidelines and using them from the inception of RCT protocols.

Assessment of Reporting Quality in Randomised Controlled Trials of Acupuncture for Post-Stroke Rehabilitation Using the Consort Statement and Stricta Guidelines

2017 ◽  
Vol 35 (2) ◽  
pp. 100-106 ◽  
Author(s):  
Jingchun Zeng ◽  
Guohua Lin ◽  
Lixia Li ◽  
Liming Lu ◽  
Chuyun Chen ◽  
...  
Keyword(s):  
Stroke Rehabilitation ◽  
Randomised Controlled Trials ◽  
Reporting Quality ◽  
Consort Statement ◽  
Allocation Concealment ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Post Stroke ◽  
Randomised Controlled

Objectives To evaluate the completeness of reporting of randomised controlled trials (RCTs) of acupuncture for post-stroke rehabilitation in order to provide information to facilitate transparent and more complete reporting of acupuncture RCTs in this field. Methods Multiple databases were searched from their inception through September 2015. Quality of reporting for included papers was assessed against a subset of criteria adapted from the Consolidated Standards for Reporting Trials (CONSORT) 2010 statement and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines. Each item was scored 1 if it was reported, or 0 if it was not clearly stated. Descriptive statistical analysis was performed. Cohen's κ-statistics were calculated to assess agreement between the two reviewers. Results A total of 87 RCTs were included in the full text. Based on CONSORT, good reporting was evident for items “Randomised’ in the title or abstract’, ‘Participants’, ‘Statistical methods’, ‘Recruitment’, ‘Baseline data’, and ‘Outcomes and estimation’, with positive rates >80%. However, the quality of reporting for the items ‘Trial design’, ‘Outcomes’, ‘Sample size’, ‘Allocation concealment’, ‘Implementation’, ‘Blinding’, ‘Flow chart’, ‘Intent-to-treat analysis’, and ‘Ancillary analyses’ was very poor with positive rates <10%. Based on STRICTA, the items ‘Number of needle insertions per subject per session’, ‘Responses sought’, and ‘Needle type’ had poor reporting with positive rates <50%. Substantial agreement was observed for most items and good agreement was observed for some items. Conclusions The reporting quality of RCTs in acupuncture for post-stroke rehabilitation is unsatisfactory and needs improvement.

Sign in / Sign up

Export Citation Format

Share Document