Baseline Observation Carry Forward: Reasoning, Properties, and Practical Issues

Shao, Jun; Jordan, David; Pritchett, Yili

doi:10.1080/10543400902964118

Cited by 34 publications

(29 citation statements)

References 12 publications

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“…The BOCF analysis was employed because it is recognized as more conservative than LOCF in intent‐to‐treat (ITT) analyses if symptoms are expected to improve over the course of the study, as would be expected in the treatment of pain (Shao et al., 2009). …”

Section: Discussionmentioning

confidence: 99%

Capsaicin 8% patch versus oral pregabalin in patients with peripheral neuropathic pain

Haanpää

Cruccu

Nurmikko

et al. 2015

European Journal of Pain

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BackgroundClinical trials have not yet compared the efficacy of capsaicin 8% patch with current standard therapy in peripheral neuropathic pain (PNP).ObjectivesHead‐to‐head efficacy and safety trial comparing the capsaicin patch with pregabalin in PNP.MethodsOpen‐label, randomized, multicentre, non‐inferiority trial. Patients with PNP, aged 18–80 years, were randomly assigned to either the capsaicin 8% patch (n = 282) or an optimised dose of oral pregabalin (n = 277), and assessed for a ≥30% mean decrease in Numeric Pain Rating Scale (NPRS) score from baseline to Week 8. Secondary endpoints included optimal therapeutic effect (OTE), time‐to‐onset of pain relief and treatment satisfaction.ResultsThe capsaicin 8% patch was non‐inferior to pregabalin in achievement of a ≥30% mean decrease in NPRS score from baseline to Week 8 (55.7% vs. 54.5%, respectively; Odds ratio: 1.03 [95% CI: 0.72, 1.50]). The proportion of patients achieving OTE at Week 8 was 52.1% for the capsaicin 8% patch versus 44.8% for pregabalin (difference: 7.3%; 95% CI: −0.9%, 15.6%). The median time‐to‐onset of pain relief was significantly shorter for capsaicin 8% patch versus pregabalin (7.5 vs. 36.0 days; Hazard ratio: 1.68 [95% CI: 1.35, 2.08]; p < 0.0001). Treatment satisfaction was also significantly greater with the capsaicin 8% patch versus pregabalin. TEAEs were mild‐to‐moderate in severity, and resulted in treatment discontinuation only with pregabalin (n = 24). Systemic adverse drug reactions ranged from 0 to 1.1% with capsaicin 8% patch and 2.5 to 18.4% with pregabalin.ConclusionsThe capsaicin 8% patch provided non‐inferior pain relief to an optimized dose of pregabalin in PNP, with a faster onset of action, fewer systemic side effects and greater treatment satisfaction.

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Section: Discussionmentioning

confidence: 99%

Capsaicin 8% patch versus oral pregabalin in patients with peripheral neuropathic pain

Haanpää

Cruccu

Nurmikko

et al. 2015

European Journal of Pain

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“…Nevertheless, whether correction of metabolic acidosis to the level of TA-Bic>24mEq/L provides additional protection for RRF in these patients is unknown. A randomized controlled trial which was aimed to detect the effect of oral bicarbonate on nutritional status and hospitalization of CAPD patients showed a tendency of slower decrease of RRF in the oral bicarbonate group [28]. Though, the absence of significant difference between the placebo and oral bicarbonate groups was probably due to the relative short follow-up.…”

Section: Discussionmentioning

confidence: 99%

“…An intention to treat analysis, including subjects who dropped out of the trial, was adopted to avoid the effects of dropout which may break the random assignment to the treatment groups in the study. Last observation carried forward (LOCF) method was used to replace missing data to diminish the different attrition rates between the groups [28]. Overall statistical comparisons between the two groups were performed by repeated measures ANOVA.…”

Section: Methodsmentioning

confidence: 99%

Oral Bicarbonate Slows Decline of Residual Renal Function in Peritoneal Dialysis Patients

Gao²,

Zhang³

et al. 2017

Kidney Blood Press Res

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Background/Aims: Metabolic acidosis is a common consequence of end-stage renal disease (ESRD) which may result in a substantial adverse outcome. The effect of oral bicarbonate on the preservation of residual renal function (RRF) in peritoneal dialysis (PD) patients has been rarely reported. Methods: We randomly assigned 40 continuous ambulatory peritoneal dialysis (CAPD) patients to the oral bicarbonate group or placebo group at a 1: 1 ratio. All enrollments were followed for a duration of 104 weeks. We took residual creatinine clearance (CCr), a measure of residual renal function (RRF), as the primary outcome. Residual CCr was calculated as the average of urea and creatinine clearance from a 24-hour urine collection. Results: Thirteen patients in the placebo group and 15 patients in the treatment group completed the 104 weeks of follow-up with a comparable dropout rate (placebo group: 35% vs treatment group: 25%). Compared with the placebo group, serum bicarbonate in treatment group was significantly increased at each time point, and oral bicarbonate resulted in a slower declining rate of residual CCr (F=5.113, p=0.031). Baseline residual CCr at enrollment also had a significant effect on residual CCr (F=168.779, P<0.001). Charlson Comorbidity Index which was adopted to calculate a comorbidity score had no significant effect on residual CCr loss (F=0.168, P=0.685). Conclusion: Oral bicarbonate may have a RRF preserving effect in CAPD patients, and a normal to high level of serum bicarbonate (≥24mmol/L) may be appropriate for RRF preservation.

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“…The BOCF method assumes that those who drop out of the program do not benefit from their participation in treatment and continue to smoke at an expected, consistent rate. Although this method of handling missing data has many well-recognized flaws and may bias results in favor of existing associations between baseline measures (National Research Council, 2010;Shao, Jordan, & Pritchett, 2009), we elected to use this method to parallel previous work using intent-to-treat analyses on the N-O-T dataset, as this approach is one of the most commonly used in similar cessation trials (Lancaster & Stead, 2005).…”

Section: Quit Statusmentioning

confidence: 99%