Interpreting trial results following use of different intention-to-treat approaches for preventing attrition bias: a meta-epidemiological study protocol

Døssing, Anna; Tarp, Simon; Fürst, Daniel E.; Gluud, Christian; Beyene, Joseph; Hansen, Bjarke Brandt; Bliddal, Henning; Christensen, Robin

doi:10.1136/bmjopen-2014-005297

Cited by 18 publications

(11 citation statements)

References 63 publications

(70 reference statements)

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“…All available data were analyzed with an intention-to-treatapproach (66). Each participant that started the intervention was included in the analysis, regardless of the adherence rate (67). We assumed that all missing data were constant and replaced the missing values with the mean values of their allocated group (68).…”

Section: Discussionmentioning

confidence: 99%

“…As recommended in a systematic review on the quality of controlled trials (109), dropouts were analyzed in their original allocated group even if they did not participate in the entire intervention. This may have led to reduced variability of the data (68), but helped in avoiding selection and attrition bias (67,109). With a fully powered future trial both intentionto-treat and per-protocol analysis should be considered.…”

Section: Limitationsmentioning

confidence: 99%

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Combining Stochastic Resonance Vibration With Exergaming for Motor-Cognitive Training in Long-Term Care; A Sham-Control Randomized Controlled Pilot Trial

et al. 2020

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Purpose: Physical and mental functions allow classifying older adults as “Go-Go” (independent functioning); “Slow-Go” (in need of care with a slight handicap); and “No-Go” (in need of care with severe functional limitation). The latter group exhibits reduced exercise tolerance. More recently technology-based motor-cognitive types of training services emerged as a possible training service. This study examined the use of technology including stochastic resonance whole-body vibration and Exergame-dance training for motor-cognitive training in care home dwelling adults.Methods: Seventeen older adults (10 women, 7 men, age range: 79–98) were randomly assigned to the intervention (IG, n = 9) or the sham group (SG, n = 8). IG performed five sets of 1-min whole-body vibration with 1-min rest in between, three times a week for the first 4 weeks of the training period with varying frequency. From weeks five to eight the Exergame-dance training was conducted after the vibration sessions. SG performed a stochastic resonance whole-body vibration training with the same terms applied, however, with a fixed frequency of 1 Hz, Noise 1. From weeks five to eight a passive trampoline-programme of 5 min was applied following the vibration sessions. Primary outcome was the Short Physical Performance Battery (SPPB). Secondary outcomes were the Trail Making Test A and B (TMT A & B) and the Falls Efficacy Scale–International (FES-I). Outcomes were measured at baseline, after 4 and 8 weeks of intervention and at follow-up (4 weeks after the intervention). The non-parametric Puri and Sen rank-order test was applied, followed by an ANOVA for repeated measures to analyse main and interaction effects. Mann–Whitney U-Test was used to determine differences between the groups.Results: The post-hoc analysis showed significant effects on the SPPB total score with large effect sizes from baseline to 8 weeks (+72%, p = 0.005, η2 = 0.423). The TMT part B displayed significant improvements with large effect sizes from baseline to 8 weeks (+17.5%, p = 0.002, η2 = 0.779) and to follow-up (+21%, p = 0.001, η2 = 0.827).Conclusion: The technology based 8-week training programme consisting of a combination of stochastic resonance whole-body vibration and Exergame-dance training showed beneficial effects on both physical and cognitive performance in older care home dwelling adults.

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Section: Discussionmentioning

confidence: 99%

Section: Limitationsmentioning

confidence: 99%

Combining Stochastic Resonance Vibration With Exergaming for Motor-Cognitive Training in Long-Term Care; A Sham-Control Randomized Controlled Pilot Trial

et al. 2020

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“…Although in randomized studies, there is an established preference for analysis of a population using intention-to-treat (ITT) vs PPP due to a reduced risk of bias; given that our study is a non-inferiority study, the more restrictive analysis were chosen because ITT analysis tends to bias the results towards a lack of difference[ 34 ]. In this study, patient assignment was performed without blinding, a factor that may be related to selection bias[ 34 ], even though assignment without blinding is closer to routine clinical practice.…”

Section: Discussionmentioning

confidence: 99%

Tenofovir vs lamivudine plus adefovir in chronic hepatitis B: TENOSIMP-B study

Rodríguez

Pascasio

Fraga

et al. 2017

WJG

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AIMTo demonstrate the non-inferiority (15% non-inferiority limit) of monotherapy with tenofovir disoproxil fumarate (TDF) vs the combination of lamivudine (LAM) plus adefovir dipivoxil (ADV) in the maintenance of virologic response in patients with chronic hepatitis B (CHB) and prior failure with LAM.METHODSThis study was a Phase IV prospective, randomized, open, controlled study with 2 parallel groups (TDF and LAM+ADV) of adult patients with hepatitis B e antigen (HBeAg)-negative CHB, prior failure with LAM, on treatment with LAM+ADV for at least 6 mo, without prior resistance to ADV and with an undetectable viral load at the start of the study, in 14 Spanish hospitals. The follow-up time for each patient was 48 wk after randomization, with quarterly visits in which the viral load, biochemical and serological parameters, adverse effects, adherence to treatment and consumption of hospital resources were analysed.RESULTSForty-six patients were evaluated [median age: 55.4 years (30.2-75.2); 84.8% male], including 22 patients with TDF and 24 with LAM+ADV. During study development, hepatitis B virus DNA (HBV-DNA) remained undetectable, all patients remained HBeAg negative, and hepatitis B surface antigen (HBsAg) positive. Alanine aminotransferase (ALT) values at the end of the study were similar in the 2 groups (25.1 ± 7.65, TDF vs 24.22 ± 8.38, LAM+ADV, P = 0.646). No significant changes were observed in creatinine or serum phosphorus values in either group. No significant differences between the 2 groups were noted in the identification of adverse effects (AEs) (53.8%, TDF vs 37.5%, LAM+ADV, P = 0.170), and none of the AEs which occurred were serious. Treatment adherence was 95.5% and 83.3% in the TDF and the LAM+ADV groups, respectively (P = 0.488). The costs associated with hospital resource consumption were significantly lower with the TDF treatment than the LAM+ADV treatment (€4943 ± 1059 vs €5811 ± 1538, respectively, P < 0.001).CONCLUSIONTDF monotherapy proved to be safe and not inferior to the LAM+ADV combination therapy in maintaining virologic response in patients with CHB and previous LAM failure. In addition, the use of TDF generated a significant savings in hospital costs.

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“…Thus, all data analyses will be carried out according to a pre-established statistical analysis plan. The analyses for the primary and secondary endpoints will be conducted according to the ITT principle; that is, based on the full analysis set (all randomised individuals independent of protocol violations) with outcome data available (as observed) 53. For the equivalence analyses (ie, according to disease activity), imputations will not be used to replace missing data in the primary analyses, but will be included in a sensitivity analysis to assess the effect of missing data.…”

Section: Methods and Analysismentioning

confidence: 99%

Dosage reduction and discontinuation of biological disease-modifying antirheumatic drugs in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: protocol for a pragmatic, randomised controlled trial (the BIOlogical Dose OPTimisation (BIODOPT) trial)

et al. 2019

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IntroductionThe The BIOlogical Dose OPTimisation (BIODOPT) trial is a pragmatic, multicentre, randomised controlled, open-label, parallel-group, equivalence study designed to evaluate tapering of biological disease-modifying antirheumatic drugs (bDMARDs) in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) in sustained clinical remission or low disease activity (LDA). Traditionally, these patients maintain standard dosage of bDMARD lifelong; however, recent studies indicate that a significant proportion of patients in sustained remission or LDA can taper their bDMARD and maintain stable disease activity. Thus, this trial aims to evaluate whether a disease activity-guided tapering strategy for bDMARDs will enable a significant dosage reduction while maintaining disease activity compared with usual care. From the individual patient’s standpoint as well as from a societal perspective, it would be advantageous if bDMARDs could be reduced or even discontinued while maintaining disease activity.Methods and analysisA total of 180 patients with RA, PsA or axSpA treated with bDMARDs and in clinical remission/LDA during the past 12 months will be enrolled from four centres in Denmark. Patients will be randomised in a ratio of 2:1 to either disease activity-guided tapering of bDMARDs (intervention group) or continuation of bDMARDs as usual care (control group).The primary objective is the difference between the two groups in the proportion of patients who have reduced their inclusion dosage of bDMARDs to 50% or less while maintaining stable disease activity at 18 months follow-up.Ethics and disseminationThe study is approved by the ethics committee of Northern Jutland, Denmark (N-20170073) and by the Danish Medicine Agency. Patient research partner KHH contributed to refinement of the protocol and approved the final manuscript. Results will be disseminated through publication in international peer-reviewed journals.Trial registration number2017-001970-41; Pre-results.

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Interpreting trial results following use of different intention-to-treat approaches for preventing attrition bias: a meta-epidemiological study protocol

Cited by 18 publications

References 63 publications

Combining Stochastic Resonance Vibration With Exergaming for Motor-Cognitive Training in Long-Term Care; A Sham-Control Randomized Controlled Pilot Trial

Combining Stochastic Resonance Vibration With Exergaming for Motor-Cognitive Training in Long-Term Care; A Sham-Control Randomized Controlled Pilot Trial

Tenofovir vs lamivudine plus adefovir in chronic hepatitis B: TENOSIMP-B study

Dosage reduction and discontinuation of biological disease-modifying antirheumatic drugs in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: protocol for a pragmatic, randomised controlled trial (the BIOlogical Dose OPTimisation (BIODOPT) trial)

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