A systematic review finds variable use of the intention-to-treat principle in musculoskeletal randomized controlled trials with missing data

Joseph, Royes; Sim, Julius; Ogollah, Reuben; Lewis, Martyn

doi:10.1016/j.jclinepi.2014.09.002

Cited by 36 publications

(23 citation statements)

References 49 publications

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“…The dietary intakes were analyzed by the Nutritionist (IV) software. The modified intention-to-treat (m-ITT) method [28] was used for the missing data (3 participants in the intervention group and 2 ones in the placebo group) ( Fig. 2).…”

Section: Discussionmentioning

confidence: 99%

Vitamin D supplementation improves SIRT1, Irisin, and glucose indices in overweight or obese type 2 diabetic patients: a double-blind randomized placebo-controlled clinical trial

et al. 2020

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Background: Vitamin D (VD) may increase sirtuin 1 (SIRT1) and subsequently PPAR-γ coactivator 1α (PGC-1α) and irisin levels and these improvements may reduce insulin resistance (IR). The aim was to assess the effects of vitamin D supplementation on SIRT1, irisin, and IR in overweight/obese type 2 diabetes (T2D) patients. Methods: Ninety T2D males and females were recruited as a clinical trial study (mean of age and body mass index (BMI) of intervention and placebo groups were 50.05 ± 10.17 and 50.36 ± 10.2 yrs. and 31.37 ± 3.4 and 30.43 ± 3.2 kg/m 2 , respectively). The inclusion criteria were T2D, VD deficient, BMI > 25 kg/m 2 , and serum HbA1c < 8.5%. The exclusion criteria were using vitamin and mineral supplements, having any acute disease, recent modifying dose or type of drugs. The supplementation was 50,000 IU/week VD or placebo for 8 weeks. The demographic characteristics, anthropometrics, dietary intakes and physical activity status, sun exposure status, fasting blood sugar (FBS) and insulin, glycosylated hemoglobin (HbA1c), irisin, SIRT1, 25-hydroxy D3 (25(OH)VD), homeostasis model assessment of insulin resistance (HOMA-IR), and quantitative insulin sensitivity check index (QUICKI) were determined. The significant P-value was ≤0.05. Results: The increase of serum VD, SIRT1, and irisin in the intervention group was significant (p < 0.001). HbA1c was decreased significantly by 1%. The changes in the other glucose indices (FBS, insulin, and IR) were non-significant. Conclusions: VD supplementation may improve T2D by decreasing HbA1c and increasing SIRT1 and irisin in VD deficient T2D patients. Further trials are suggested. Trial registration: Iranian Registry of Clinical Trials, IRCT201604202365N11. Registered 21/08/2016, http://en.irct. ir/trial/2019.

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Section: Discussionmentioning

confidence: 99%

Vitamin D supplementation improves SIRT1, Irisin, and glucose indices in overweight or obese type 2 diabetic patients: a double-blind randomized placebo-controlled clinical trial

et al. 2020

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“…This is in harmony with current best practices and recommendations for appropriate conduction of RCTs, recommending a multi-faceted approach to data analysis that centers on use of ITT [4]. This is also an improvement compared to previous evaluations of musculoskeletal and ear, nose, and throat (ENT) RCTs, where fewer studies (68 % and 12 %, respectively) used ITT or mITT as the primary data analysis population [6, 8]. While use of ITT is not specifically recommended in CONSORT, the relatively consistent use of ITT and mITT supports CONSORT Item 13, which advocate for clarity in describing the numbers of patients analyzed for each outcome, and providing reasons for patient exclusions [1].…”

Section: Discussionmentioning

confidence: 79%

“…These results were worse than prior studies where this information was provided in 58 to 65 % of RCTs [6, 16]. To the investigators’ knowledge, there is no current, rigorous standard regarding an ideal approach to this practice.…”

Section: Discussionmentioning

confidence: 80%

“…Investigators conducted a preliminary literature search that identified a two-year search timeframe would likely identify approximately 100 RCTs meeting study criteria. A goal anticipated sample of 100 RCTs was selected based on prior similar studies [6, 8]. …”

Section: Methodsmentioning

confidence: 99%

“…Few previous studies describe whether published RCTs are meeting the CONSORT recommendation of clearly defining the population that was analyzed; however, available studies suggest significant gaps, particularly in describing how missing data are handled [5, 6]. In the absence of consistently applied principles, medical professionals are left to compare trials of similar drugs under potentially very different conditions.…”

Section: Introductionmentioning

confidence: 99%

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Intention-to-treat and transparency of related practices in randomized, controlled trials of anti-infectives

Beckett

Loeser

Bowman³

et al. 2016

BMC Med Res Methodol

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BackgroundIntention-to-treat (ITT) analysis is commonly recommended for use, due to its benefits on external validity, in randomized, controlled trials (RCTs). No published reports describe how ITT analysis, as well as alternative approaches, are used in anti-infective RCTs. The purpose of this study is to describe the extent to which ITT analysis and alternative data approaches are used, the practices used to handle missing subject data, and whether non-inferiority trials present both ITT and per protocol (PP) analyses. Results of this analysis will help guide end users of infectious diseases primary drug literature.MethodsA cross-sectional study of RCTs of anti-infectives published from January 1, 2013 through December 31, 2014 was conducted. A PubMed search identified relevant articles published in five specialty infectious diseases journals and four general medical journals. Each article was reviewed by two independent investigators with discrepancies resolved by consensus. Descriptive statistics were used to quantify results.ResultsOne hundred four articles met study criteria. The most common medication classes represented in the RCTs were hepatitis C antivirals (26 %), antibacterials (25 %), and antiretrovirals (21 %). Thirty studies (29 %) were non-inferiority trials. Most studies (77 %) described use of ITT or modified ITT (mITT) in their methods. Of the ITT and mITT studies, most (73 %) did not describe practices used to handle missing data. Most (97 %) non-inferiority trials described use of ITT, mITT, or both; however, only 15 (50 %) also described use of PP.ConclusionsRCTs of anti-infectives commonly employ ITT and mITT. Most do not describe how missing data were addressed. Non-inferiority trials of anti-infectives do not consistently employ both ITT and PP populations.Electronic supplementary materialThe online version of this article (doi:10.1186/s12874-016-0215-2) contains supplementary material, which is available to authorized users.

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Sources of Bias in Randomised Controlled Trials

2021

Evidence in Medicine

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A systematic review finds variable use of the intention-to-treat principle in musculoskeletal randomized controlled trials with missing data

Abstract: It appears that many trials reporting missing data are inappropriately analyzed and may therefore be prone to biased estimates and invalid inferences.

Cited by 36 publications

References 49 publications

Vitamin D supplementation improves SIRT1, Irisin, and glucose indices in overweight or obese type 2 diabetic patients: a double-blind randomized placebo-controlled clinical trial

Vitamin D supplementation improves SIRT1, Irisin, and glucose indices in overweight or obese type 2 diabetic patients: a double-blind randomized placebo-controlled clinical trial

Intention-to-treat and transparency of related practices in randomized, controlled trials of anti-infectives

Sources of Bias in Randomised Controlled Trials

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