scholarly journals Correction: Online Alcohol Assessment and Feedback for Hazardous and Harmful Drinkers: Findings From the AMADEUS-2 Randomized Controlled Trial of Routine Practice in Swedish Universities

2016 ◽  
Vol 18 (5) ◽  
pp. e118
Author(s):  
Preben Bendtsen ◽  
Marcus Bendtsen ◽  
Nadine Karlsson ◽  
Ian R White ◽  
Jim McCambridge
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Routine Practice ◽  
Randomized Controlled ◽  
Alcohol Assessment

scholarly journals Text messaging as a tool to improve cancer screening programs (M-TICS Study): A randomized controlled trial protocol

PLoS ONE ◽  
2021 ◽  
Vol 16 (1) ◽  
pp. e0245806
Author(s):  
Nuria Vives ◽  
Albert Farre ◽  
Gemma Ibáñez-Sanz ◽  
Carmen Vidal ◽  
Gemma Binefa ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cancer Screening ◽  
Screening Program ◽  
Controlled Trial ◽  
Population Based ◽  
Routine Practice ◽  
Screening Programs ◽  
Crc Screening ◽  
Randomized Controlled ◽  
The Impact

Background Short message service (SMS) based interventions are widely used in healthcare and have shown promising results to improve cancer screening programs. However, more research is still needed to implement SMS in the screening process. We present a study protocol to assess the impact on health and economics of three targeted SMS-based interventions in population-based cancer screening programs. Methods/Design The M-TICs study is a randomized controlled trial with a formal process evaluation. Participants aged 50–69 years identified as eligible from the colorectal cancer (CRC) and breast cancer (BC) screening program of the Catalan Institute of Oncology (Catalonia, Spain) will be randomly assigned to receive standard invitation procedure (control group) or SMS-based intervention to promote participation. Two interventions will be conducted in the CRC screening program: 1) Screening invitation reminder: Those who do not participate in the CRC screening within 6 weeks of invite will receive a reminder (SMS or letter); 2) Reminder to complete and return fecal immunochemical test (FIT) kit: SMS reminder versus no intervention to individuals who have picked up a FIT kit at the pharmacy and they have not returned it after 14 days. The third intervention will be performed in the BC screening program. Women who had been screened previously will receive an SMS invitation or a letter invitation to participate in the screening. As a primary objective we will assess the impact on participation for each intervention. The secondary objectives will be to analyze the cost-effectiveness of the interventions and to assess participants’ perceptions. Expected results The results from this randomized controlled trial will provide important empirical evidence for the use of mobile phone technology as a tool for improving population-based cancer screening programs. These results may influence the cancer screening invitation procedure in future routine practice. Trial registration Registry: NCT04343950 (04/09/2020); clinicaltrials.gov.

scholarly journals Translating research to usual care of children with sickle cell disease in Northern Nigeria: lessons learned from the SPRING Trial Team

2022 ◽  
Vol 15 (1) ◽  
Author(s):  
Halima Bello-Manga ◽  
Lawal Haliru ◽  
Abdulkadir M. Tabari ◽  
Bilkisu Farouk ◽  
Aisha Suleiman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Usual Care ◽  
Sickle Cell ◽  
Organizational Support ◽  
Stroke Prevention ◽  
Controlled Trial ◽  
Routine Practice ◽  
Northern Nigeria ◽  
Randomized Controlled

Abstract Objectives Evidence-based practice for stroke prevention in high-income countries involves screening for abnormal transcranial Doppler (TCD) velocity and initiating regular blood transfusions for at least 1 year, followed by treatment with hydroxyurea. This practice has not been transferred to low-resource settings like Nigeria, the country with the highest global population density of SCD. Following a multi-center randomized controlled trial among children with SCA in northern Nigeria, screening for stroke and initiation of hydroxyurea was established as standard of care at the clinical trial sites and other locations. We aim to describe the critical steps we took in translating research into practice for stroke prevention in SCA in Nigeria. Guided by the PRISM framework, we describe how we translated results from a randomized controlled trial for primary prevention of stroke in children with sickle cell anemia into usual care for children with SCA in Kaduna, Nigeria. Results Findings from this study demonstrate the importance of organizational support and stakeholder involvement from the onset of a clinical trial. Having the dual objective of conducting an efficacy trial while simultaneously focusing on strategies for future implementation can significantly decrease the lag time between discovery and routine practice.

Behandlung der sozialen Angststörungen unter Routinebedingungen

2018 ◽  
Vol 68 (03/04) ◽  
pp. 98-98
Keyword(s):  
Randomized Controlled Trial ◽  
Anxiety Disorder ◽  
Social Anxiety Disorder ◽  
Behavioral Treatment ◽  
Controlled Trial ◽  
Routine Practice ◽  
Cognitive Behavioral Treatment ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Cluster Randomized

Hoyer J. et al. Manualized cognitive therapy versus cognitive-behavioral treatment-as-usual for social anxiety disorder in routine practice: A cluster-randomized controlled trial. Behav Res Ther 2017; 95: 87–98

A service evaluation of a group mindfulness-based intervention for distressing voices: how do findings from a randomized controlled trial compare with routine clinical practice?

2020 ◽  
pp. 1-15
Author(s):  
Anna-Marie Jones ◽  
Clara Strauss ◽  
Mark Hayward
Keyword(s):  
Randomized Controlled Trial ◽  
Clinical Practice ◽  
Controlled Trial ◽  
Service Level ◽  
Service Evaluation ◽  
Routine Clinical Practice ◽  
Routine Practice ◽  
Linear Regression Models ◽  
Randomized Controlled ◽  
Level Data

Abstract Background: Person-based cognitive therapy (PBCT) was developed as a treatment for psychosis. The effectiveness of group PBCT was examined in the Mindfulness for Voices (M4V) randomized controlled trial and generated promising results. Group PBCT was implemented as a trans-diagnostic treatment for distressing voices within the Sussex Voices Clinic (SVC), a specialist secondary care mental health service. Aim: To conduct a service evaluation of engagement, outcomes and cost of group PBCT within SVC, and to compare engagement and outcomes from routine practice with the M4V trial. Secondary aims were to explore predictors of levels of engagement and change in group PBCT. Method: Service level data from 95 SVC patients were evaluated. Descriptive statistics, hypothesis tests and linear regression models were used. The primary clinical outcome was voice-related distress. Engagement levels and pre–post effect sizes were estimated; associated predictors were explored. Results: Fifty-nine per cent of patients completed group PBCT within SVC, compared with 72% within M4V. Completers within SVC had lower baseline depression scores compared with non-completers. There were significant improvements in voice-related distress (Cohen’s d = –0.47; p = 0.001), subjective recovery (Cohen’s d = 0.35; p = 0.001) and depression (Cohen’s d = –0.20; p = 0.044); these outcomes were comparable to M4V. Higher baseline subjective recovery and lower depression both predicted improvement in voice-related distress. Therapy within SVC cost an average of £214 per patient. Conclusion: PBCT groups can be delivered trans-diagnostically in routine clinical practice. Engagement was lower when compared with an RCT, but outcomes were comparable. The low level of resources involved suggests that group PBCT can offer value for money.

scholarly journals Acceptability and Feasibility of Implementing Accelorometry-Based Activity Monitors and a Linked Web Portal in an Exercise Referral Scheme: Feasibility Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Jemma Hawkins ◽  
Joanna M Charles ◽  
Michelle Edwards ◽  
Britt Hallingberg ◽  
Linda McConnon ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Routine Practice ◽  
Usual Practice ◽  
Intervention Delivery ◽  
Wearable Technologies ◽  
Randomized Controlled ◽  
Context Specific ◽  
Exercise Referral

BACKGROUND Exercise referral schemes (ERSs) are recommended for patients with health conditions or risk factors. Evidence points to the initial effectiveness and cost-effectiveness of such schemes for increasing physical activity, but effects often diminish over time. Techniques such as goal setting, self-monitoring, and personalized feedback may support motivation for physical activity and maintenance of effects. Wearable technologies could provide an opportunity to integrate motivational techniques into exercise schemes. However, little is known about acceptability to exercise referral populations or implementation feasibility within exercise referral services. OBJECTIVE To determine the feasibility and acceptability of implementing an activity-monitoring device within the Welsh National ERS to inform a decision on whether and how to proceed to an effectiveness trial. METHODS We conducted a feasability randomized controlled trial with embedded mixed-methods process evaluation and an exploratory economic analysis. Adults (N=156) were randomized to intervention (plus usual practice; n=88) or usual practice only (n=68). Usual practice was a 16-week structured exercise program. The intervention group additionally received an accelerometry-based activity monitor (MyWellnessKey) and associated Web platform (MyWellnessCloud). The primary outcomes were predefined progression criteria assessing acceptability and feasibility of the intervention and proposed evaluation. Postal questionnaires were completed at baseline (time 0:T0), 16 weeks (T1), and 12 months after T0 (T2). Routine data were accessed at the same time-points. A subsample of intervention participants and scheme staff were interviewed following the initiation of intervention delivery and at T2. RESULTS Participants were on average aged 56.6 (SD 16.3) years and mostly female (101/156, 64.7%) and white (150/156, 96.2%). Only 2 of 5 progression criteria were met; recruitment and randomization methods were acceptable to participants, and contamination was low. However, recruitment and retention rates (11.3% and 67.3%, respectively) fell substantially short of target criteria (20% and 80%, respectively), and disproportionally recruited from the least deprived quintile. Only 57.4% of intervention participants reported receipt of the intervention (below the 80% progression threshold). Less than half reported the intervention to be acceptable at T2. Participant and staff interviews revealed barriers to intervention delivery and engagement related to the device design as well as context-specific technological challenges, all of which made it difficult to integrate the technology into the service. Routinely collected health economic measures had substantial missing data, suggesting that other methods for collecting these should be used in future. CONCLUSIONS To our knowledge, this is the first study to evaluate short- and long-term feasibility and acceptability of integrating wearable technologies into community-based ERSs. The findings highlight device- and context-specific barriers to doing this in routine practice, with typical exercise referral populations. Key criteria for progression to a full-scale evaluation were not met. CLINICALTRIAL ISRCTN Registry ISRCTN85785652; http://www.isrctn.com/ISRCTN85785652

Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

2020 ◽  
Vol 29 (1S) ◽  
pp. 412-424
Author(s):  
Elissa L. Conlon ◽  
Emily J. Braun ◽  
Edna M. Babbitt ◽  
Leora R. Cherney
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Treatment Fidelity ◽  
Protocol Adherence ◽  
Study Condition ◽  
Randomized Controlled ◽  
Aphasia Therapy ◽  
Percent Accuracy ◽  
Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

Phonomotor Versus Semantic Feature Analysis Treatment for Anomia in 58 Persons With Aphasia: A Randomized Controlled Trial

2019 ◽  
Vol 62 (12) ◽  
pp. 4464-4482 ◽  
Author(s):  
Diane L. Kendall ◽  
Megan Oelke Moldestad ◽  
Wesley Allen ◽  
Janaki Torrence ◽  
Stephen E. Nadeau
Keyword(s):  
Randomized Controlled Trial ◽  
Response Latency ◽  
Controlled Trial ◽  
Semantic Knowledge ◽  
Semantic Feature ◽  
Feature Analysis ◽  
Group Differences ◽  
Randomized Controlled ◽  
Confrontation Naming ◽  
Semantic Feature Analysis

Purpose The ultimate goal of anomia treatment should be to achieve gains in exemplars trained in the therapy session, as well as generalization to untrained exemplars and contexts. The purpose of this study was to test the efficacy of phonomotor treatment, a treatment focusing on enhancement of phonological sequence knowledge, against semantic feature analysis (SFA), a lexical-semantic therapy that focuses on enhancement of semantic knowledge and is well known and commonly used to treat anomia in aphasia. Method In a between-groups randomized controlled trial, 58 persons with aphasia characterized by anomia and phonological dysfunction were randomized to receive 56–60 hr of intensively delivered treatment over 6 weeks with testing pretreatment, posttreatment, and 3 months posttreatment termination. Results There was no significant between-groups difference on the primary outcome measure (untrained nouns phonologically and semantically unrelated to each treatment) at 3 months posttreatment. Significant within-group immediately posttreatment acquisition effects for confrontation naming and response latency were observed for both groups. Treatment-specific generalization effects for confrontation naming were observed for both groups immediately and 3 months posttreatment; a significant decrease in response latency was observed at both time points for the SFA group only. Finally, significant within-group differences on the Comprehensive Aphasia Test–Disability Questionnaire ( Swinburn, Porter, & Howard, 2004 ) were observed both immediately and 3 months posttreatment for the SFA group, and significant within-group differences on the Functional Outcome Questionnaire ( Glueckauf et al., 2003 ) were found for both treatment groups 3 months posttreatment. Discussion Our results are consistent with those of prior studies that have shown that SFA treatment and phonomotor treatment generalize to untrained words that share features (semantic or phonological sequence, respectively) with the training set. However, they show that there is no significant generalization to untrained words that do not share semantic features or phonological sequence features.

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