Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial

Background Results of small trials indicate that fluoxetine might improve functional outcomes after stroke. The FOCUS trial aimed to provide a precise estimate of these effects. Methods FOCUS was a pragmatic, multicentre, parallel group, double-blind, randomised, placebo-controlled trial done at 103 hospitals in the UK. Patients were eligible if they were aged 18 years or older, had a clinical stroke diagnosis, were enrolled and randomly assigned between 2 days and 15 days after onset, and had focal neurological deficits. Patients were randomly allocated fluoxetine 20 mg or matching placebo orally once daily for 6 months via a web-based system by use of a minimisation algorithm. The primary outcome was functional status, measured with the modified Rankin Scale (mRS), at 6 months. Patients, carers, health-care staff, and the trial team were masked to treatment allocation. Functional status was assessed at 6 months and 12 months after randomisation. Patients were analysed according to their treatment allocation. This trial is registered with the ISRCTN registry, number ISRCTN83290762. Findings Between Sept 10, 2012, and March 31, 2017, 3127 patients were recruited. 1564 patients were allocated fluoxetine and 1563 allocated placebo. mRS data at 6 months were available for 1553 (99·3%) patients in each treatment group. The distribution across mRS categories at 6 months was similar in the fluoxetine and placebo groups (common odds ratio adjusted for minimisation variables 0·951 [95% CI 0·839–1·079]; p=0·439). Patients allocated fluoxetine were less likely than those allocated placebo to develop new depression by 6 months (210 [13·43%] patients vs 269 [17·21%]; difference 3·78% [95% CI 1·26–6·30]; p=0·0033), but they had more bone fractures (45 [2·88%] vs 23 [1·47%]; difference 1·41% [95% CI 0·38–2·43]; p=0·0070). There were no significant differences in any other event at 6 or 12 months. Interpretation Fluoxetine 20 mg given daily for 6 months after acute stroke does not seem to improve functional outcomes. Although the treatment reduced the occurrence of depression, it increased the frequency of bone fractures. These results do not support the routine use of fluoxetine either for the prevention of post-stroke depression or to promote recovery of function. Funding UK Stroke Association and NIHR Health Technology Assessment Programme

Recruitment of research participants

Successful recruitment and retention of study participants is essential for the overall success of a research study. The recruitment process involves identifying potential research participants and providing them with the information to establish their interest to join a proposed research study. Research studies are often time and labour intensive and inappropriate recruitment of research participants can significantly impact the study findings. This chapter will introduce readers to a range of associated issues, and offer possible solutions and mitigation strategies to enhance research participant engagement. First, this chapter describes the issues surrounding investigators’ and potential participants’ expectations related to their involvement in research. Next, the chapter will identify the facilitators, barriers, and challenges associated with recruitment and retention of participant. Then, the chapter will highlight some traditional and modern recruitment and retention techniques, for participation in health research across the life course: children and adolescents, adults, and seniors. Last, the chapter will detail the specific attention, resources, and sensitivity required to maximise recruitment and retention when conducting research with specific population groups such as minority populations and medically compromised people

Diagnostic performance of planar scintigraphy using (99m)Tc-MIBI in patients with secondary hyperparathyroidism: a meta-analysis

Parathyroid scintigraphy using (99m)Tc-MIBI is not currently considered a valuable diagnostic tool for the localization of involved glands in patients with secondary hyperparathyroidism (SHPT). However, published data about its diagnostic accuracy are discordant and a meta-analysis about this topic is still lacking. The aim of our study is to meta-analyze the published data about the diagnostic performance of (99m)Tc-MIBI parathyroid scintigraphy in patients with SHPT