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 ‘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 Relative effectiveness of a full versus reduced version of the ‘Smoke Free’ mobile application for smoking cessation: a randomised controlled trial

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 1524 ◽  
Author(s):  
David Crane ◽  
Harveen Kaur Ubhi ◽  
Jamie Brown ◽  
Robert West
Keyword(s):  
Smoking Cessation ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Relative Effectiveness ◽  
Behaviour Change Techniques ◽  
Full Version ◽  
Intention To Treat ◽  
Support Programmes ◽  
Randomised Controlled

Background: Smartphone applications (apps) are popular aids for smoking cessation. Smoke Free is an app that delivers behaviour change techniques used in effective face-to-face behavioural support programmes. The aim of this study was to assess whether the full version of Smoke Free is more effective than the reduced version. Methods:  This was a two-arm randomised controlled trial. Smokers who downloaded Smoke Free were randomly offered the full or reduced version; 28,112 smokers aged 18+ years who set a quit date were included. The full version provided updates on benefits of abstinence, progress (days smoke free), virtual ‘badges’ and daily ‘missions’ with push notifications aimed at preventing and managing cravings. The reduced version did not include the missions. At baseline the app recorded users’: device type (iPhone or Android), age, sex, daily cigarette consumption, time to first cigarette of the day, and educational level. The primary outcome was self-reported complete abstinence from the quit date in a 3-month follow-up questionnaire delivered via the app. Analyses conducted included logistic regressions of outcome on to app version (full versus reduced) with adjustment for baseline variables using both intention-to-treat/missing-equals smoking (MES) and follow-up-only (FUO) analyses. Results: The 3-month follow-up rate was 8.5% (n=1,213) for the intervention and 6.5% (n=901) for the control. A total of 234 participants reported not smoking in the intervention versus 124 in the control, representing 1.6% versus 0.9% in the MES analysis and 19.3% versus 13.8% in the FUO analysis. Adjusted odds ratios were 1.90, 95%CI=1.53-2.37 (p<0.001) and 1.50, 95%CI=1.18-1.91 (p<0.001) in the MES and FUO analyses respectively. Conclusions: Despite very low follow-up rates using in-app follow up, both intention-to-treat/missing equals smoking and follow-up only analyses showed the full version of the Smoke Free app to result in higher self-reported 3-month continuous smoking abstinence rates than the reduced version.

scholarly journals Effect of manual therapy in patients with hemophilia and ankle arthropathy: a randomized clinical trial

2019 ◽  
Vol 34 (1) ◽  
pp. 111-119 ◽  
Author(s):  
Elena Donoso-Úbeda ◽  
Javier Meroño-Gallut ◽  
José Antonio López-Pina ◽  
Rubén Cuesta-Barriuso
Keyword(s):  
Manual Therapy ◽  
Joint Pain ◽  
Controlled Trial ◽  
Control Group ◽  
Load Bearing ◽  
Intention To Treat ◽  
Joint Health ◽  
Experimental Group ◽  
Treat Analysis

Objective: The aim of this study was to evaluate the effects of a manual therapy using fascial therapy on joint bleeding, joint pain and joint function in patients with hemophilic ankle arthropathy. Setting: Hemophilia patient associations. Design: Randomized, controlled trial, multicenter and intention-to-treat analysis. Participants: A total of 65 patients with hemophilic ankle arthropathy. Intervention: The experimental group ( n = 33) received one fascial therapy session per week for three weeks. The control group ( n = 32) received no treatment. Outcome measure: The primary outcome was frequency of joint bleeding measured using self-reporting. Secondary outcomes were joint pain (under load-bearing and non-load-bearing conditions) measured using the visual analog scale; joint condition was measured using the Hemophilia Joint Health Score. Outcomes were measured at baseline, posttreatment and after five months of follow-up. Results: Improvements in the frequency joint bleeding at T0, T1 and T2 were significantly higher in the experimental group (T0: mean (SD) = 1.56 (1.30); T1: mean (SD) = 0.00 (0.00); T2: mean (SD) = 0.27 (0.57)) compared to the control group (T0: mean (SD) = 1.70 (1.78); T1: mean (SD) = 0.05 (0.21); T2: mean (SD) = 0.58 (0.85)). Mean improvement of joint state after the study period was 1.74 points (±1.66) for patients in the experimental group, while the control group exhibited a joint deterioration with 0.43 points (±0.85). Ankle joint pain under load-bearing and non-load-bearing conditions improved in the experimental group with −1.72 (±1.86) and −0.50 (±1.39) points, respectively. Conclusion: The study showed that fascial therapy is favorable for patients with hemophilic ankle arthropathy.

scholarly journals Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial

Thorax ◽  
2020 ◽  
Vol 75 (5) ◽  
pp. 413-421 ◽  
Author(s):  
Henrik Hansen ◽  
Theresa Bieler ◽  
Nina Beyer ◽  
Thomas Kallemose ◽  
Jon Torgny Wilcke ◽  
...  
Keyword(s):  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Drop Out ◽  
Group Differences ◽  
Primary Analysis ◽  
Intention To Treat ◽  
Registration Number ◽  
Randomised Controlled

RationalePulmonary rehabilitation (PR) is an effective, key standard treatment for people with COPD. Nevertheless, low participant uptake, insufficient attendance and high drop-out rates are reported. Investigation is warranted of the benefits achieved through alternative approaches, such as pulmonary tele-rehabilitation (PTR).ObjectiveTo investigate whether PTR is superior to conventional PR on 6 min walk distance (6MWD) and secondarily on respiratory symptoms, quality of life, physical activity and lower limb muscle function in patients with COPD and FEV1 <50% eligible for routine hospital-based, outpatient PR.MethodsIn this single-blinded, multicentre, superiority randomised controlled trial, patients were assigned 1:1 to 10 weeks of groups-based PTR (60 min, three times weekly) or conventional PR (90 min, two times weekly). Assessments were performed by blinded assessors at baseline, end of intervention and at 22 weeks’ follow-up from baseline. The primary analysis was based on the intention-to-treat principle.Measurements and main resultsThe primary outcome was change in 6MWD from baseline to 10 weeks; 134 participants (74 females, mean±SD age 68±9 years, FEV1 33%±9% predicted, 6MWD 327±103 metres) were included and randomised. The analysis showed no between-group differences for changes in 6MWD after intervention (9.2 metres (95% CI: −6.6 to 24.9)) or at 22 weeks’ follow-up (−5.3 metres (95% CI: −28.9 to 18.3)). More participants completed the PTR intervention (n=57) than conventional PR (n=43) (χ2 test p<0.01).ConclusionPTR was not superior to conventional PR on the 6MWD and we found no differences between groups. As more participants completed PTR, supervised PTR would be relevant to compare with conventional PR in a non-inferiority design.Trial registration numberClinicalTrials.gov (NCT02667171), 28 January 2016.

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).

Presenting a randomised controlled trial

2013 ◽  
Author(s):  
Janet L. Peacock ◽  
Sally M. Kerry
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Consort Statement ◽  
Intention To Treat ◽  
The Consort Statement ◽  
Randomised Controlled ◽  
Treat Analysis

Chapter 12 covers presenting a randomised controlled trial, including the CONSORT statement and checklist, intention to treat analysis, and presenting trials with other designs.

scholarly journals Cost-effectiveness of cell salvage and donor blood transfusion during caesarean section: results from a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e022352 ◽  
Author(s):  
Carol McLoughlin ◽  
Tracy E Roberts ◽  
Louise J Jackson ◽  
Philip Moore ◽  
Matthew Wilson ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Caesarean Section ◽  
Blood Transfusion ◽  
Controlled Trial ◽  
Mean Difference ◽  
Cell Salvage ◽  
Donor Blood ◽  
Intention To Treat ◽  
The Mean ◽  
Randomised Controlled

ObjectivesTo evaluate the cost-effectiveness of routine use of cell salvage during caesarean section in mothers at risk of haemorrhage compared with current standard of care.DesignModel-based cost-effectiveness evaluation alongside a multicentre randomised controlled trial. Three main analyses were carried out on the trial data: (1) based on the intention-to-treat principle; (2) based on the per-protocol principle; (3) only participants who underwent an emergency caesarean section.Setting26 obstetric units in the UK.Participants3028 women at risk of haemorrhage recruited between June 2013 and April 2016.InterventionsCell salvage (intervention) versus routine care without salvage (control).Primary outcome measuresCost-effectiveness based on incremental cost per donor blood transfusion avoided.ResultsIn the intention-to-treat analysis, the mean difference in total costs between cell salvage and standard care was £83. The estimated incremental cost-effectiveness ratio (ICER) was £8110 per donor blood transfusion avoided. For the per-protocol analysis, the mean difference in total costs was £92 and the ICER was £8252. In the emergency caesarean section analysis, the mean difference in total costs was £55 and the ICER was £13 713 per donor blood transfusion avoided. This ICER is driven by the increased probability that these patients would require a higher level of postoperative care and additional surgeries. The results of these analyses were shown to be robust for the majority of deterministic sensitivity analyses.ConclusionsThe results of the economic evaluation suggest that while routine cell salvage is a marginally more effective strategy than standard care in avoiding a donor blood transfusion, there is uncertainty in relation to whether it is a less or more costly strategy. The lack of long-term data on the health and quality of life of patients in both arms of the trial means that further research is needed to fully understand the cost implications of both strategies.Trial registration numberISRCTN66118656.

scholarly journals Augmentation of clozapine with ECT: a retrospective case analysis

2020 ◽  
pp. 1-6
Author(s):  
John Lally ◽  
Emily Breese ◽  
Mugtaba Osman ◽  
Cai Hua Sim ◽  
Hitesh Shetty ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Meta Analysis ◽  
Retrospective Case ◽  
Clozapine Treatment ◽  
Duration Of Illness ◽  
Maintenance Ect ◽  
The Mean ◽  
Randomised Controlled ◽  
Clinical Global Impression Improvement

Abstract Objective: We sought to assess the effectiveness of clozapine augmentation with Electroconvulsive therapy (ECT) (C+ECT) in patients with clozapine-resistant schizophrenia. Methods: We conducted a retrospective review of electronic health records to identify patients treated with C+ECT. We determined the response to C+ECT and the rate of rehospitalisation over the year following treatment with C+ECT. Results: Forty-two patients were treated with C+ECT over a 10-year period. The mean age of the patients at initiation of ECT was 46.3 (SD = 8.2) years (range 27–62 years). The mean number of ECTs given was 10.6 (SD = 5.3) (range 3–25) with the majority receiving twice weekly ECT. Seventy-six per cent of patients (n = 32) showed a Clinical Global Impression-Improvement (CGI-I) score of ≤3 (at least minimally improved) following C+ECT. The mean number of ECT treatments was 10.6 (SD = 5.3) (range 3–25) with the majority receiving twice weekly ECT. Sixty-four per cent of patients experienced no adverse events. Response to C+ECT was not associated with gender, age, duration of illness or duration of clozapine treatment. Seventy-five per cent of responders remained out of hospital over the course of 1-year follow-up, while 70% of those with no response to C+ECT were not admitted to hospital. Three patients received maintenance ECT, one of whom was rehospitalised. Conclusion: This study lends support to emerging evidence for the effectiveness of C+ECT in clozapine-resistant schizophrenia. These results are consistent with the results of a meta-analysis and the only randomised controlled trial (RCT) of this intervention. Further RCTs are required before this treatment can be confidently recommended.

Protective efficacy of 6-week regimen for latent tuberculosis infection treatment in rural China: 5-year follow-up of a randomised controlled trial

2021 ◽  
pp. 2102359
Author(s):  
Henan Xin ◽  
Xuefang Cao ◽  
Haoran Zhang ◽  
Boxuan Feng ◽  
Ying Du ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Protocol Analysis ◽  
Latent Tuberculosis Infection ◽  
Protective Efficacy ◽  
Controlled Trial ◽  
Latent Tuberculosis ◽  
Protection Rate ◽  
Ifn Γ ◽  
Randomised Controlled

BackgroundEnlarging tuberculosis (TB) preventive treatment among at-risk populations is a critical component of the End TB Strategy. It is urgently needed to develop suitable latent tuberculosis infection (LTBI) testing and treatment tools according to local TB epidemic and available resources in worldwide.MethodsBased on an open-labeled randomised controlled trial conducted since 2015 among rural residents aged 50–70 years with LTBI, the protective efficacy of the 6-week twice-weekly regimen of rifapentine plus isoniazid was further evaluated in a 5-year follow-up survey.ResultsA total of 1298 treated participants and 1151 untreated controls were included in the 5-year protective efficacy analysis. In the per-protocol analysis, the incidence rate was 0.49/100 person-years (95% confidence interval (CI): 0.30–0.67) in the untreated control group and 0.19/100 person-years (95% CI: 0.07–0.32) in the treated group, the protection rate was 61.22%. Subgroup analysis showed that the protection rate was 76.82% in the per-protocol analysis among participants with baseline IFN-γ levels in the highest quartile (≥3.25 IU·mL−1). The multiple logistic regression analysis indicated that participants with baseline BMI <18.5 kg·m−2 and with pulmonary fibrotic lesions had increased hazard of developing active disease with an adjusted hazard ratio (aHR) of 3.64 (95% CI: 1.20–11.00) and 5.99 (95% CI: 2.20–16.27), respectively. In addition, individuals with higher baseline IFN-γ levels showed an increased risk of TB occurrence (aHR 2.27, 95% CI 1.13–4.58).ConclusionsOur findings suggested the 6-week twice-weekly regimen of rifapentine plus isoniazid for LTBI treatment might be an optional tool for TB control in Chinese population.

Comparison of two dose escalation strategies of methotrexate in active rheumatoid arthritis: a multicentre, parallel group, randomised controlled trial

2021 ◽  
pp. annrheumdis-2021-220512
Author(s):  
Siddharth Jain ◽  
Varun Dhir ◽  
Amita Aggarwal ◽  
Ranjan Gupta ◽  
Bidyalaxmi Leishangthem ◽  
...  
Keyword(s):  
Dose Escalation ◽  
Controlled Trial ◽  
Group Differences ◽  
Drug Discontinuation ◽  
Open Label ◽  
Intention To Treat ◽  
Parallel Group ◽  
Registration Number ◽  
Randomised Controlled

ObjectivesThere are no head-to-head trials of different dose escalation strategies of methotrexate (MTX) in RA. We compared the efficacy, safety and tolerability of ‘usual’ (5 mg every 4 weeks) versus ‘fast’ (5 mg every 2 weeks) escalation of oral MTX.MethodsThis multicentre, open-label (assessor blinded) RCT included patients 18-55 years of age having active RA with disease duration <5 years, and not on DMARDs. Patients were randomized 1:1 into usual or fast escalation groups, both groups starting MTX at 15 mg/week till a maximum of 25 mg/week. Primary outcome was EULAR good response at 16 weeks, secondary outcomes were ΔDAS28 and adverse effects (AE). Analyses were intention-to-treat.Results178 patients with mean DAS28-CRP of 5.4(1.1) were randomized to usual (n=89) or fast escalation groups (n=89). At 16 weeks, there was no difference in good EULAR response in the usual (28.1%) or fast escalation (22.5%) groups (p=0.8). There was no difference in mean ΔDAS28-CRP at 8 weeks (-0.9, -0.8, p=0.72) or 16 weeks (-1.3, -1.3, p=0.98). Even at 24 weeks (extended follow-up), responses were similar. There were no inter-group differences in ΔHAQ, or MTX-polyglutamates 1-3 levels at 8 or 16 weeks. Gastrointestinal AE were higher in the fast escalation group over initial 8 weeks (27%, 40%, p=0.048), but not over 16 weeks. There was no difference in cytopenias, transaminitis, or drug discontinuation/dose reduction between the groups. No serious AE were seen.ConclusionA faster MTX escalation strategy in RA was not more efficacious over 16-24 weeks, and did not significantly increase AE, except higher gastrointestinal AE initially.Trial registration numberCTRI/2018/12/016549

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