The culture of designing hepato-biliary randomised trials

Paring and intense pulsed light versus paring alone for recalcitrant hand and foot warts: A randomized clinical trial with blinded outcome evaluation

“…IPL patients reported more pain and as this is a patient-reported outcome and patients were not blinded to intervention we cannot tell if this pain was real or perceived [19][20][21]. However, pain of mild to moderate intensities related to IPL is a known adverse effect [23][24][25].…”

“…High-quality randomized clinical trials are, therefore, important in order to assess the true treatment efficacy, and there is a particular need for randomized clinical trials in the field of light and laser treatments of warts due to lack of existing evidence. In this randomized trial, we used welldefined in-and exclusion criteria to ensure a homogenous study population, as well as we applied centralized treatment allocation, blinded evaluation of treatment outcome and blinded data analysis in order to minimize investigator-associated bias [19][20][21].…”

Meta‐analysis: antioxidant supplements for liver diseases – the Cochrane Hepato‐Biliary Group

“…64,65 The use of new interventions in hepatology should not be justified until these have been proven to be beneficial on clinical outcomes. 66,67 The increase in the number of hepato-biliary randomized trials will never be considered a sufficient valuable source for data if aspects of the trial design, like sample size, completeness of data reporting, duration of follow-up and bias risk, are not improved, and trial performance and reporting do not follow the CONSORT guidelines. 68 Our results are in accordance with the results of other recently published meta-analyses and systematic reviews [9][10][11][12][13][14] as well as recommendations of the United…”

Hepatology may have problems with putative surrogate outcome measures

“…Well-designed and -executed randomised clinical trials constitute the gold standard for assessing the benefits and harms of a new intervention [16][17][18][19][20][21]. In phase III trials, the primary outcome ideally is a clinical outcome measure such as mortality, need for liver transplantation, or variceal bleeding.…”

“…As a result, hepatologists may be prone to making errors that are disservices to their patients. In general, hepatology needs more definitive clinical trials [20,21].…”