SummaryBackgroundResults of small trials indicate that fluoxetine might improve functional outcomes after stroke. The FOCUS trial aimed to provide a precise estimate of these effects.MethodsFOCUS 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.FindingsBetween 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.InterpretationFluoxetine 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.FundingUK Stroke Association and NIHR Health Technology Assessment Programme.
In 2012, I conducted my first PhD study exploring general practitioners' attitudes toward online patient feedback. After designing the research questions and topic guide to conduct the interviews, I reviewed existing literature where authors described recruiting general practitioners to take part in research. I found there was some focus in the literature on the challenges associated with low general practitioner participation in survey-based and intervention studies, but little that described the process, experience, and challenges associated with recruiting general practitioners to take part in qualitative research. Although general practitioners are known to be a difficult group to recruit to take part in research, the recruitment process I experienced was much more challenging than I had anticipated. This case study sheds light on my experience of recruiting 20 general practitioners in England to an interview-based study, and outlines a critical reflection on the eight strategies used for recruitment. I started by using traditional methods such as postal invitations and faxes to recruit general practitioners. Due to the very low success rate, I resorted to using more inexpensive and creative methods, such as sending an invitation letter through email, advertising in general practitioner Email Newsletters, seeking help from existing research networks, recruiting through friends and acquaintances, and using social media. In this case study, I also describe the participants' (general practitioners') motivations for taking part in the study, and I conclude with offering suggestions on how to maximize response rates to general practitioner-based qualitative studies in England. Learning Outcomes By the end of the case, students should be able to Have a better understanding of the potential challenges faced when recruiting general practitioners (GPs) to take part in research Understand that sometimes probability sampling cannot be used due to difficulties with recruiting Learn to be creative and flexible when recruiting participants to research Understand the strategies and approaches that could be used to increase GP participation in research Project Overview and Context In 2012, I embarked on conducting a qualitative interview study with general practitioners (GPs), exploring their attitudes toward online patient feedback. GPs are the first point of call for patients in the United Kingdom. They treat all common medical conditions and refer patients to hospitals or other medical services for specialist or urgent care. Once my research questions and interview topic guide was designed, I focused my energies on exploring what strategies I should use for recruiting GPs to the study and what type of response rate I should expect.
Bortezomib treatment requires four visits to a chemotherapy unit in each 21-day cycle. Analysis of the Day 1 full blood count could allow clinicians to predict the risk of Grade 4 thrombocytopenia, thus negating the need to review the full blood count prior to each dose. The freedom to administer bortezomib without reviewing full blood count results on each treatment day could minimise appointment times and be a step toward home administration. A prospective study of treatment authorisation following a full toxicity assessment and full blood count results from the previous treatment day was undertaken. The full blood count results from 27 patients, receiving 381 doses revealed 12 treatment episodes where bortezomib was administered in the presence of Grade 4 thrombocytopenia. One instance of bleeding and two episodes of neutropenic sepsis were detected during toxicity assessments and treatment was not administered. Only one instance of Grade 4 thrombocytopenia was reported on any other treatment day when the Day 1 platelet count was greater than 75 × 10(9) units/l. From this data, Day 1 full blood count parameters were derived, which minimise the risk of Grade 4 haematological toxicity on subsequent treatment days, allowing clinicians to identify suitable patients for administration of bortezomib prior to reviewing full blood count results. When platelet counts on Day 1 are greater than 75 × 10(9) units/l and neutrophil counts are greater than 1.0 × 10(9) units/l, the administration of bortezomib can be authorised without the need for review of the full blood count on subsequent days of that cycle.
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