Within person trial is an efficient study design for randomized controlled trials which has been widely used in fields of dentistry, dermatology and ophthalmology. However, due to a series of inherent methodological difficulties, the design, conduct and reporting of within person trials usually requires additional methodological knowledge and considerations from researchers. To standardize and improve the reporting quality of these trials, the BMJ recently published the CONSORT statement extension for within person trials. The present article aimed to provide interpretation of this reporting guideline, and thereby promote its understanding and use among Chinese researchers.
Objective To systematically review the effect of mobile phone management applications (APP) on biological and biochemical parameters in adults with type 2 diabetes mellitus (T2DM). Methods We electronically searched databases including PubMed, EMbase, The Cochrane Library, Web of Science, CINAHL, PsycINFO, WanFang Data, CBM, CNKI for randomized controlled trials compared mobile phone APP as interventions for managing T2DM with traditional methods from inception to September 30th 2016. Two researchers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was conducted using Stata 12.0 software. Results A total of 10 studies including 1 030 participants (563 in the App group and 467 in the traditional group) were included. The results of meta-analysis showed that the mobile phone app-based interventions group were superior to the control group in HbA1c (MD=–0.43, 95% CI –0.65 to –0.22, P<0.001), systolic blood pressure (MD=–2.53, 95% CI –4.89 to –0.17,P<0.05), triglyceride (SMD=–0.24, 95% CI –0.42 to –0.06,P<0.05) and waist circumference (MD=–1.57, 95% CI –2.65 to –0.48,P<0.05). No significant different were found on any other related results between two groups. Conclusion Mobile phone apps aimed at diabetes management can improve HbA1c, systolic blood pressure, triglyceride, and waist circumference for patients with T2DM. Due to the limited quality and quantity of the included studies, the above conclusions are needed more high quality studies to verify.