Abstract:

The objective of this study was to assess the quality of randomized controlled trials (RCTs) on pharmaceutical care for asthmatic patients conducted by pharmacists in mainland China, to identify the problems in current studies, and to provide some references for further studies. The China National Knowledge Infrastructure (CNKI), Wanfang Database, and VIP Database were searched for randomized controlled trials on pharmaceutical care for asthmatic patients, and only those studies undertaken by pharmacists were included. Information about the study design and reporting of selected studies was extracted and collected to systematically analyze these studies. Meanwhile, the Cochrane Collaboration‟s tool for assessing risk of bias was used to assess potential biases related to these studies. Ultimately, 14 articles were included in this study. No study determined the sample size in a scientific way. No article reported a scientific and detailed method of random sequence generation or allocation concealment. Two (14.3%) studies claimed to have implemented a double-blinding and a single-blinding respectively, but neither of them reported any details about how they performed the blinding. No study employed a blinding of outcome assessment. Five (35.7%) studies either stated statistical methods incompletely or used them incorrectly. One (7.1%) study reported an attrition without employing an intention-to-treat analysis. All studies reported eligibility criteria for participants to some extent, and all these criteria involved diagnosis of asthma, but only four (28.6%) of them reported patients‟ ages and three (21.4%) described the severity and the stage of asthma. Nine (64.3%) reported baseline data in the text rather than in a table, and 13 (92.9%) involved comparisons between groups with significance tests either explicitly or implicitly. No report made a distinction between primary and secondary outcomes. Two (14.3%) mentioned informed consent of subjects, while no article reported ethical approval. “Unclear risk” made up the highest percentage of the studies analyzed according to the risk of bias assessment by the Cochrane Collaboration‟s tool. Our study demonstrates that the quality of RCTs on pharmaceutical care for asthmatic patients conducted by Chinese pharmacists is suboptimal, especially with regards to study design and reporting.

Key words: Asthma, Pharmaceutical care, Pharmacist, Randomized controlled trial, Quality assessment