scholarly journals ‘New Medicine Service’: supporting adherence in people starting a new medication for a long-term condition: 26-week follow-up of a pragmatic randomised controlled trial

2019 ◽  
Vol 29 (4) ◽  
pp. 286-295 ◽  
Author(s):  
Rachel Ann Elliott ◽  
Matthew J Boyd ◽  
Lukasz Tanajewski ◽  
Nick Barber ◽  
Georgios Gkountouras ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Controlled Trial ◽  
Intention To Treat ◽  
Link Type ◽  
Medicine Service ◽  
Randomised Controlled ◽  
Treat Analysis ◽  
New Medicine Service

ObjectiveTo examine the effectiveness and cost-effectiveness of the community pharmacy New Medicine Service (NMS) at 26 weeks.MethodsPragmatic patient-level parallel randomised controlled trial in 46 English community pharmacies. 504 participants aged ≥14, identified in the pharmacy when presenting a prescription for a new medicine for predefined long-term conditions, randomised to receive NMS (n=251) or normal practice (n=253) (NMS intervention: 2 consultations 1 and 2 weeks after prescription presentation). Adherence assessed through patient self-report at 26-week follow-up. Intention-to-treat analysis employed. National Health Service (NHS) costs calculated. Disease-specific Markov models estimating impact of non-adherence combined with clinical trial data to calculate costs per extra quality-adjusted life-year (QALY; NHS England perspective).ResultsUnadjusted analysis: of 327 patients still taking the initial medicine, 97/170 (57.1%) and 103/157 (65.6%) (p=0.113) patients were adherent in normal practice and NMS arms, respectively. Adjusted intention-to-treat analysis: adherence OR 1.50 (95% CI 0.93 to 2.44, p=0.095), in favour of NMS. There was a non-significant reduction in 26-week NHS costs for NMS: −£104 (95% CI −£37 to £257, p=0.168) per patient. NMS generated a mean of 0.04 (95% CI −0.01 to 0.13) more QALYs per patient, with mean reduction in lifetime cost of −£113.9 (−1159.4, 683.7). The incremental cost-effectiveness ratio was −£2758/QALY (2.5% and 97.5%: −38 739.5, 34 024.2. NMS has an 89% probability of cost-effectiveness at a willingness to pay of £20 000 per QALY.ConclusionsAt 26-week follow-up, NMS was unable to demonstrate a statistically significant increase in adherence or reduction in NHS costs, which may be attributable to patient attrition from the study. Long-term economic evaluation suggested NMS may deliver better patient outcomes and reduced overall healthcare costs than normal practice, but uncertainty around this finding is high.Trial registration numberNCT01635361, ISRCTN23560818, ISRCTN23560818, UKCRN12494.

scholarly journals Cost-effectiveness of an app-based treatment for urinary incontinence in comparison to care as usual in general practice: A pragmatic randomised controlled trial over 12 months

2021 ◽  
Author(s):  
Anne Loohuis ◽  
Henk van der Worp ◽  
Nienke Wessels ◽  
Janny Dekker ◽  
Marijke Slieker-ten Hove ◽  
...  
Keyword(s):  
Primary Care ◽  
Urinary Incontinence ◽  
Cost Effectiveness ◽  
Mobile Apps ◽  
Controlled Trial ◽  
Intention To Treat ◽  
Life Years ◽  
Randomised Controlled

Objective: Long-term cost-effectiveness of app-based treatment for female stress, urgency, or mixed urinary incontinence (UI) compared to care-as-usual in primary care. Design: A pragmatic, randomised controlled, superiority trial. Setting: Primary care in the Netherlands from 2015 to 2018, follow-up at 12 months. Population: Women with ≥2 UI-episodes per week, access to mobile apps, wanting treatment. 262 women randomised equally to app or care-as-usual; 89 (68%) and 83 (63%) attended follow-up. Methods: The standalone app included conservative management for UI with motivation aids (e.g., reminders). Care-as-usual delivered according to the Dutch GP guideline for UI. Main outcome measures: Effectiveness assessed by the change in symptom severity score (ICIQ-UI-SF) and the change in quality of life (ICIQ-LUTS-QoL, EQ-5D-5L) on superiority with linear regression on an intention-to-treat basis. Cost-effectiveness and -utility from a societal perspective, based on Incontinence Impact Adjusted Life Years (IIALYs) and Quality Adjusted Life years (QALYs). Results: Clinically relevant improvement of UI severity for both app (-2.17 ± 2.81) and care-as-usual (-3.43 ± 3.6), with a non-significant mean difference of 0.903 (-0.66 to 1.871). Costs were lower for app-based treatment with \euro-161 (95%CI: -180 to -151) per year. Cost-effectiveness showed small mean differences in effect for IIALY (0.04) and QALY (-0.03) and thus larger ICER (-3,696) and ICUR (\euro6,379). Conclusion: App-based treatment is a viable alternative to care-as-usual for UI in primary care in terms of long-term cost-effectiveness. Funding: Dutch Organisation for Health Research and Development (ZonMw: 837001508), sub-funding P.W. Boer Foundation Dutch Trial Register identifier: Trial NL4948 (www.trialregister.nl/trial/4948).

scholarly journals Telemedical coaching for weight loss in overweight employees: a three-armed randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e022242 ◽  
Author(s):  
Kerstin Kempf ◽  
Martin Röhling ◽  
Stephan Martin ◽  
Michael Schneider
Keyword(s):  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Weight Reduction ◽  
Controlled Trial ◽  
Eating Behaviour ◽  
Healthcare Setting ◽  
Intention To Treat ◽  
Link Type ◽  
Randomised Controlled

ObjectivesWe examined the effect of a telemedical coaching (TMC) programme accompanied with or without telemonitoring on weight loss in an occupational healthcare setting with a three-armed randomised controlled trial (NCT01837134’Pre-results').MethodsOverweight employees (n=104, body mass index [BMI] ≥25 kg/m2) were invited by their medical corporate department and randomised into either a TMC group (n=34) or in one of the two control groups (C1, n=34; C2, n=36). TMC and C1 were equipped with telemonitoring devices (scales and pedometers) at baseline, and C2 after 6 months. Telemonitoring devices automatically transferred data into a personalised online portal. TMC was coached with weekly care calls in months 3–6 and monthly calls from months 7 to 12. C2 had a short coaching phase in months 6–9. C1 received no further support. After the 12-month intervention phase, participants could take advantage of further company health promotion offers. Follow-up data were determined after 12 months of intervention and per-protocol (PP) and intention-to-treat (ITT) analyses were performed. Weight change was followed up after 36 months. Estimated treatment difference (ETD) was calculated for weight reduction.ResultsETD from TMC to C1 (−3.6 kg 95% CI −7.40 to −0.1, p=0.047) and to C2 (−4.2 kg [−7.90 to −0.5], p=0.026) was significantly different at the 12 months follow-up in the PP-analysis, but lost significance in the ITT analysis. All groups reduced weight after 12 months (−3.3 to −8.4 kg [5.5–10.3 kg], all p<0.01) and sustained it during the 36 months follow-up (−4.8 to −7.8 kg [5.6–12.8 kg], all p<0.01). ETD analyses revealed no difference between all groups neither in the PP nor in the ITT analysis at the 3 years follow-up. All groups reduced BMI, systolic and diastolic blood pressure and improved eating behaviour in the PP or ITT analyses.ConclusionsTMC and/or telemonitoring support long-term weight reduction in overweight employees. The combination of both interventions points towards an additional effect.Trial registration numberNCT01837134.

scholarly journals Update to the effectiveness and cost-effectiveness of a mindfulness training programme in schools compared with normal school provision (MYRIAD): study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jesus Montero-Marin ◽  
◽  
Elizabeth Nuthall ◽  
Sarah Byford ◽  
Catherine Crane ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Primary Endpoint ◽  
Controlled Trial ◽  
Mindfulness Training ◽  
Secondary Outcome ◽  
Link Type ◽  
Randomised Controlled

Abstract Background MYRIAD (My Resilience in Adolescence) is a superiority, parallel group, cluster randomised controlled trial designed to examine the effectiveness and cost-effectiveness of a mindfulness training (MT) programme, compared with normal social and emotional learning (SEL) school provision to enhance mental health, social-emotional-behavioural functioning and well-being in adolescence. The original trial protocol was published in Trials (accessible at 10.1186/s13063-017-1917-4). This included recruitment in two cohorts, enabling the learning from the smaller first cohort to be incorporated in the second cohort. Here we describe final amendments to the study protocol and discuss their underlying rationale. Methods Four major changes were introduced into the study protocol: (1) there were changes in eligibility criteria, including a clearer operational definition to assess the degree of SEL implementation in schools, and also new criteria to avoid experimental contamination; (2) the number of schools and pupils that had to be recruited was increased based on what we learned in the first cohort; (3) some changes were made to the secondary outcome measures to improve their validity and ability to measure constructs of interest and to reduce the burden on school staff; and (4) the current Coronavirus Disease 2019 (SARS-CoV-2 or COVID-19) pandemic both influences and makes it difficult to interpret the 2-year follow-up primary endpoint results, so we changed our primary endpoint to 1-year follow-up. Discussion These changes to the study protocol were approved by the Trial Management Group, Trial Steering Committee and Data and Ethics Monitoring Committees and improved the enrolment of participants and quality of measures. Furthermore, the change in the primary endpoint will give a more reliable answer to our primary question because it was collected prior to the COVID-19 pandemic in both cohort 1 and cohort 2. Nevertheless, the longer 2-year follow-up data will still be acquired, although this time-point will be now framed as a second major investigation to answer some new important questions presented by the combination of the pandemic and our study design. Trial registration International Standard Randomised Controlled Trials ISRCTN86619085. Registered on 3 June 2016.

scholarly journals Evaluating the effectiveness of the smartphone app, Drink Less, compared with the NHS alcohol advice webpage, for the reduction of alcohol consumption among hazardous and harmful adult drinkers in the UK at six-month follow-up: protocol for a randomised controlled trial

2020 ◽  
Author(s):  
Claire Garnett ◽  
Melissa Oldham ◽  
Colin Angus ◽  
Emma Beard ◽  
Robyn Burton ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Alcohol Consumption ◽  
Large Scale ◽  
Controlled Trial ◽  
Economic Evaluations ◽  
Intention To Treat ◽  
Randomised Controlled ◽  
The Uk

AbstractBackground and AimsDigital interventions are effective for reducing alcohol consumption but evidence is limited regarding smartphone apps. Drink Less is a theory- and evidence-informed app to help people reduce their alcohol consumption that has been refined in terms of its content and design for usability across the socio-demographic spectrum. We aim to evaluate the effectiveness and cost-effectiveness of recommending Drink Less at reducing alcohol consumption compared with usual digital care.DesignTwo-arm individually randomised controlled trial.SettingOnline trial in the UK.ParticipantsHazardous or harmful drinkers (Alcohol Use Disorders Identification Test score >=8) aged 18+, and want to drink less alcohol (n=5,562). Participants will be recruited from July 2020 to May 2022 using multiple strategies with a focus on remote digital methods.Intervention and comparatorParticipants will be randomised to receive either an email recommending that they use Drink Less (intervention) or view the NHS webpage on alcohol advice (comparator).MeasurementsThe primary outcome is change in self-reported weekly alcohol consumption between baseline and 6-month follow-up. Secondary outcomes include the proportion of hazardous drinkers; alcohol-related problems and injury; health-related quality of life, and use of health services assessed at 6-month follow-up. Effectiveness will be examined with one-way ANCOVAs, adjusting for baseline alcohol consumption, and using an intention-to-treat approach. A mixed-methods process evaluation will assess engagement, acceptability and mechanism of action. Economic evaluations will be conducted using both a short- and longer-term time horizon.CommentsThis study will establish the effectiveness and cost-effectiveness of the Drink Less app at reducing alcohol consumption among hazardous and harmful adult drinkers and will be the first RCT of an alcohol reduction app for the general population in the UK. This study will inform the decision on whether it is worth investing resources in large-scale implementation.

scholarly journals Randomised comparison of postpolypectomy surveillance intervals following a two-round baseline colonoscopy: the Japan Polyp Study Workgroup

Gut ◽  
2020 ◽  
pp. gutjnl-2020-321996
Author(s):  
Takahisa Matsuda ◽  
Takahiro Fujii ◽  
Yasushi Sano ◽  
Shin-ei Kudo ◽  
Yasushi Oda ◽  
...  
Keyword(s):  
Protocol Analysis ◽  
Controlled Trial ◽  
Low Grade ◽  
Intention To Treat ◽  
Neoplastic Lesions ◽  
The Mean ◽  
Low Grade Dysplasia ◽  
Randomised Controlled ◽  
Treat Analysis

ObjectiveTo assess whether follow-up colonoscopy after polypectomy at 3 years only, or at 1 and 3 years would effectively detect advanced neoplasia (AN), including nonpolypoid colorectal neoplasms (NP-CRNs).DesignA prospective multicentre randomised controlled trial was conducted in 11 Japanese institutions. The enrolled participants underwent a two-round baseline colonoscopy (interval: 1 year) to remove all neoplastic lesions. Subsequently, they were randomly assigned to undergo follow-up colonoscopy at 1 and 3 years (2-examination group) or at 3 years only (1-examination group). The incidence of AN, defined as lesions with low-grade dysplasia ≥10 mm, high-grade dysplasia or invasive cancer, at follow-up colonoscopy was evaluated.ResultsA total of 3926 patients were enrolled in this study. The mean age was 57.3 (range: 40–69) years, and 2440 (62%) were male. Of these, 2166 patients were assigned to two groups (2-examination: 1087, 1-examination: 1079). Overall, we detected 29 AN in 28 patients at follow-up colonoscopy in both groups. On per-protocol analysis (701 in 2-examination vs 763 in 1-examination group), the incidence of AN was similar between the two groups (1.7% vs 2.1%, p=0.599). The results of the non-inferiority test were significant (p=0.017 in per-protocol, p=0.001 in intention-to-treat analysis). NP-CRNs composed of dominantly of the detected AN (62%, 18/29), and most of them were classified into laterally spreading tumour non-granular type (83%, 15/18).ConclusionAfter a two-round baseline colonoscopy, follow-up colonoscopy at 3 years detected AN, including NP-CRNs, as effectively as follow-up colonoscopies performed after 1 and 3 years.

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 Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Laura Williams ◽  
Charlotte L. Hall ◽  
Sue Brown ◽  
Boliang Guo ◽  
Marilyn James ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Controlled Trial ◽  
Medication Management ◽  
Control Group ◽  
Global Functioning ◽  
Children And Young People ◽  
Link Type ◽  
Randomised Controlled

Abstract Background Medication for attention deficit hyperactivity disorder (ADHD) should be closely monitored to ensure optimisation. There is growing interest in using computerised assessments of ADHD symptoms to support medication monitoring. The aim of this study was to assess the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate the efficacy of one such computerised assessment, the Quantified Behavior (Qb) Test, as part of medication management for ADHD. Methods This feasibility multi-site RCT conducted in child and adolescent mental health and community paediatric settings recruited participants aged 6–15 years diagnosed with ADHD starting stimulant medication. Participants were randomised into one of two arms: experimental (QbTest protocol) where participants completed a QbTest at baseline and two follow-up QbTests on medication (2–4 weeks and 8–10 weeks later) and control where participants received treatment as usual, including at least two follow-up consultations. Measures of parent, teacher, and clinician-rated symptoms and global functioning were completed at each time point. Clinicians recorded treatment decision-making and health economic measures were obtained. Data were analysed using multi-level modelling and participants (children and parents) and clinicians were interviewed about their experiences, resulting data were thematically analysed. Results Forty-four children and young people were randomised. Completion of study outcome measures by care-givers and teachers ranged from 52 to 78% at baseline to 47–65% at follow-up. Participants reported the questionnaires to be useful to complete. SNAP-IV inattention scores showed greater reduction in the intervention than the control group (− 5.85, 95% CI − 10.33, − 1.36,). Engagement with the intervention ranged from 100% at baseline, to 78% follow-up 1 and 57% follow-up 2. However, only 37% of QbTests were conducted in the correct time period. Interview data highlighted that the objectivity of the QbTest was appreciated by clinicians and parents. Clinicians commented that the additional time and resources required meant that it is not feasible to use QbTest for all cases. Conclusion The trial design and protocol appear to be feasible and acceptable but could be improved by modifying QbTest time periods and the method of data collection. With these changes, the protocol may be appropriate for a full trial. Adding QbTest may improve symptom outcome as measured by SNAP-IV. Trial registration ClinicalTrials.gov, NCT03368573, prospectively registered, 11th December 2017, and ISRCTN, ISRCTN69461593, retrospectively registered, 10th April 2018

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