What is meant by intention to treat analysis? Survey of published randomised controlled trials

Hollis, Sally; Campbell, Fiona

doi:10.1136/bmj.319.7211.670

Cited by 1,872 publications

(1,318 citation statements)

References 32 publications

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“…At all other follow-ups, the last value was carried forward [19,24]. Missing data about satisfaction at 3-month postoperatively were imputed using the 6-month value.…”

Section: Discussionmentioning

confidence: 99%

Postoperative rehabilitation does not improve functional outcome in lumbar spinal stenosis: a prospective study with 2-year postoperative follow-up

et al. 2011

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“…At all other follow-ups, the last value was carried forward [19,24]. Missing data about satisfaction at 3-month postoperatively were imputed using the 6-month value.…”

Section: Discussionmentioning

confidence: 99%

Postoperative rehabilitation does not improve functional outcome in lumbar spinal stenosis: a prospective study with 2-year postoperative follow-up

et al. 2011

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“…Study results were evaluated with the intent to treat population which is a suitable application in pragmatic trials meaning that the effectiveness of vitamin D treatment was assessed in conjunction with routine clinical practice [170,171]. between groups is difficult to explain in such a small sample size (n=12).…”

Section: Strengths and Limitationsmentioning

confidence: 99%

Effect of high-dose vitamin D supplementation on bone density in youth with osteogenesis imperfecta: A randomized controlled trial

Plante

Veilleux

Glorieux

et al. 2016

Bone

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Background Osteogenesis imperfecta (OI) is a genetic disease characterized by fragile bones and short stature. Recently, a positive association was found between serum 25‐hydroxyvitamin D (25OHD) concentrations and lumbar spine areal bone mineral density (LS‐aBMD) z‐scores in this population. Objectives: To assess whether high‐dose vitamin D supplementation (2000 IU) will result in significantly higher LS‐aBMD z‐scores after one‐year; and to evaluate the effect of vitamin D supplementation on lower limb muscle power. Results: At baseline, average serum 25OHD concentration was 65.6 nmol/L (SD 20.4) with no difference seen between treatment groups (p=0.77). Deficient serum 25OHD concentrations (<50 nmol/L) were measured in only 21% of patients at baseline. Supplementation resulted in higher serum 25OHD concentrations in almost all participants (90%) with significantly higher increases seen with 2000 IU (mean [95% C.I.] = 30.5 nmol/L [21.3; 39.6] vs 15.2 nmol/L [6.4; 24.1], p= 0.02). No significant changes were detected in BMD measurements or in lower limb muscle power between treatment groups from baseline to final visit. Conclusions Supplementation with either 400 or 2000 IU of vitamin D translates into significant increases in serum 25OHD concentrations in children with OI. However, increases in baseline serum 25OHD concentrations already within a healthy range (蠅50 nmol/L) do not translate into increases in BMD z‐scores in children with OI. This research was supported by the Shriners Hospital for Children as well as by The Network for Oral and Bone Health Research.

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“…In an additional analysis, patients who dropped out were included. 28 Comparisons were made using t-test and analysis of variance with adjustment for contributing baseline characteristics, including BP. As this design involves a superiority comparison, a one-tail P-value is required, 29 that is, given two interventions A and B, a superiority comparison of response to A þ B with response to A requires one-tail P-value, whereas a similarity comparison of A with B requires two tails.…”

Section: Study Populationmentioning

confidence: 99%

Treating hypertension in type II diabetic patients with device-guided breathing: a randomized controlled trial

et al. 2008

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The objective of the study was to evaluate the efficacy of device-guided breathing to lower blood pressure (BP) in hypertensive type II diabetic patients. A randomized controlled trial was carried out in four urban family practice clinics in Israel. Non-insulin-dependent diabetic, hypertensive patients with uncontrolled BP, receiving antihypertensive therapy or those non-medicated were enrolled. Baseline characteristics of the 66 patients who completed the study (33 intervention and 33 control) were: 62% men, age 62±8 years (mean±s.d.); body mass index 29±5 kg/m 2 ; systolic BP 148±11 mm Hg and diastolic BP 81 ± 9 mm Hg. The intervention group used a device (RESPeRATE), which interactively guides the user towards slow and regular breathing by synchronizing respiration voluntarily to musical tones for 15 min daily for an 8-week period. The control group continued with their regular treatment. BP was measured in the clinic at baseline, after 4 weeks and at 8 weeks.Medication was unchanged for 4 weeks prior to and during the study period. The main outcome measure was the office BP change from baseline to the end of the 8-week period. BP was reduced in the treatment group (mean ± s.e.) systolic À10.0 ± 1.8 mm Hg and diastolic À3.6 ± 1.3 mm Hg (Po0.0001 and Po0.01), but not in the controls þ 1.6±2.1 and À1.0±1.4 mm Hg P40.4 and P40.4, respectively. Test for between group difference Po0.0001 and P ¼ 0.08. The subjects were highly compliant with the treatment, performing 75% of the requested exercise sessions. Greater BP reduction was observed with increased compliance with device usage (P ¼ 0.01 and P ¼ 0.001). It is concluded that self-treatment with device-guided breathing at home for 8 weeks by non-insulin-dependent diabetic patients was associated with a substantial reduction in office systolic BP.

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What is meant by intention to treat analysis? Survey of published randomised controlled trials

Abstract: Objectives To assess the methodological quality of intention to treat analysis as reported in randomised controlled trials in four large medical journals.

Cited by 1,872 publications

References 32 publications

Postoperative rehabilitation does not improve functional outcome in lumbar spinal stenosis: a prospective study with 2-year postoperative follow-up

Postoperative rehabilitation does not improve functional outcome in lumbar spinal stenosis: a prospective study with 2-year postoperative follow-up

Effect of high-dose vitamin D supplementation on bone density in youth with osteogenesis imperfecta: A randomized controlled trial

Treating hypertension in type II diabetic patients with device-guided breathing: a randomized controlled trial

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