Background: Randomized controlled trials (RCTs), or experiments, are the gold standard for intervention evaluation. However, the main appeal of RCTs--the clean identification of causal effects--can be compromised by interference, when one subject's actions can influence another subject's behavior or outcomes. In this paper, we formalize and study…

Background: Although existing studies have shown that both repetitive transcranial magnetic stimulation (rTMS) and music therapy have advantages in the treatment of non-fluent aphasia, the efficacy of the combination of these two methods remains to be investigated. Aims: To investigate the clinical efficacy of low-frequency rTMS combined with…

Some patients benefit from a treatment while others may do so less or do not benefit at all. We have previously developed a two-stage network meta-regression prediction model that synthesized randomized trials and evaluates how treatment effects vary across patient characteristics. In this article, we extended this model to combine different…

Using the Hartung-Knapp method and 95% prediction intervals (PIs) in random-effects meta-analyses is recommended by experts but rarely applied. Therefore, we aimed to reevaluate statistically significant meta-analyses using the Hartung-Knapp method and 95% PIs. In this methodological study, three databases were searched from January 2010 to July…

Rare events meta-analyses of randomized controlled trials (RCTs) are often underpowered because the outcomes are infrequent. Real-world evidence (RWE) from non-randomized studies may provide valuable complementary evidence about the effects of rare events, and there is growing interest in including such evidence in the decision-making process.…

During drug development, a biomarker is sometimes identified as separating a patient population into those with more and those with less benefit from evaluated treatments. Consequently, later studies might be targeted, while earlier ones are performed in mixed patient populations. This poses a challenge in evidence synthesis, especially if only…

Indirect comparisons are used to obtain estimates of relative effectiveness between two treatments that have not been compared in the same randomized controlled trial, but have instead been compared against a common comparator in separate trials. Standard indirect comparisons use only aggregate data, under the assumption that there are no…

It is now widely accepted that the standard inferential toolkit used by the scientific research community--null-hypothesis significance testing (NHST)--is not fit for purpose. Yet despite the threat posed to the scientific enterprise, there is no agreement concerning alternative approaches for evidence assessment. This lack of consensus reflects…

Background: Network meta-analysis (NMA) of survival data with a multidimensional treatment effect has been introduced as an alternative to NMA based on the proportional hazards assumption. However, these flexible models have some limitations, such as the use of an approximate likelihood based on discrete hazards, rather than a likelihood for…

Incentivising has shown to improve participation in clinical trials. However, ethical concerns suggest that incentives may be coercive, obscure trial risks and encourage individuals to enrol in clinical trials for the wrong reasons. The aim of our study was to develop and pilot a discrete choice experiment (DCE) to explore and identify preferences…

Prior studies have demonstrated successful irritability treatment using dopaminergic antagonists in autistic patients. The purpose of this pilot study was to assess the effect of dextromethorphan/quinidine (DM/Q) in autistic adults (18-60 years of age). This was a randomized, blinded, crossover, study of 14 patients randomized to DM/Q or a placebo…

Purpose: The aim of this study was to investigate secondary voice outcomes and detraining effects of 2 head and neck strengthening exercises, which have been used in swallowing rehabilitation, that is, the head-lift exercise (HLE) and the recline exercise (RE), in healthy older adults. Method: Twenty-seven healthy older adults (between 60 and 85…

A non-inferiority design accepts the possibility of some efficacy loss, as part of a "successful", statistically significant result. That loss may be excessive when the non-inferiority threshold is lenient. However, even stringent significance thresholds and safety monitoring may fail to adequately protect study participants when the…

Education is an important aspect of care for diabetic patients. This study aimed to compare the effect of education by health care provider and peer on self-care behaviors among Iranian patients with diabetes. In this clinical randomized control trial, we enrolled 120 patients with type 2 diabetes who were referred to the Diabetes Clinic at a…

Wound cleansing remains a corner stone in the management of diabetic foot ulcer. Hydrogen Peroxide (H[subscript 2]O[subscript 2]) and Povidone Iodine are topical antimicrobial agents but known to be toxic to cells involved in the wound healing cascade. The biggest challenge for the physicians and nurses is searching for a safe, noncytotoxic and…