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  • 1. Graham, C.
    et al.
    Lewis, S.
    Forbes, J.
    Mead, G.
    Hackett, M. L.
    Hankey, G. J.
    Gommans, J.
    Nguyen, H. T.
    Lundström, E.
    Isaksson, E.
    Näsman, Per
    KTH.
    Rudberg, A. -S
    Dennis, M.
    The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: Statistical and health economic analysis plan for the trials and for the individual patient data meta-analysis2017Ingår i: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 18, nr 1, artikel-id 627Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Background: Small trials have suggested that fluoxetine may improve neurological recovery from stroke. FOCUS, AFFINITY and EFFECTS are a family of investigator-led, multicentre, parallel group, randomised, placebo-controlled trials which aim to determine whether the routine administration of fluoxetine (20 mg daily) for six months after an acute stroke improves patients' functional outcome. Methods/Design: The core protocol for the three trials has been published (Mead et al., Trials 20:369, 2015). The trials include patients aged 18 years and older with a clinical diagnosis of stroke and persisting focal neurological deficits at randomisation 2-15 days after stroke onset. Patients are randomised centrally via each trials' web-based randomisation system using a common minimisation algorithm. Patients are allocated fluoxetine 20 mg once daily or matching placebo capsules for six months. The primary outcome measure is the modified Rankin scale (mRS) at six months. Secondary outcomes include: living circumstances; the Stroke Impact Scale; EuroQol (EQ5D-5 L); the vitality subscale of the 36-Item Short Form Health Survey (SF36); diagnosis of depression; adherence to medication; serious adverse events including death and recurrent stroke; and resource use at six and 12 months and the mRS at 12 months. Discussion: Minor variations have been tailored to the national setting in the UK (FOCUS), Australia, New Zealand and Vietnam (AFFINITY) and Sweden (EFFECTS). Each trial is run and funded independently and will report its own results. A prospectively planned individual patient data meta-analysis of all three trials will provide the most precise estimate of the overall effect and establish whether any effects differ between trials or subgroups. This statistical analysis plan describes the core analyses for all three trials and that for the individual patient data meta-analysis. Recruitment and follow-up in the FOCUS trial is expected to be completed by the end of 2018. AFFINITY and EFFECTS are likely to complete follow-up in 2020.

  • 2. Howick, Jeremy
    et al.
    Mebius, Alexander
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Filosofi och teknikhistoria, Filosofi.
    In search of justification for the unpredictability paradox2014Ingår i: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 15, nr 480Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    A 2011 Cochrane Review found that adequately randomized trials sometimes revealed larger, sometimes smaller, and often similar effect sizes to inadequately randomized trials. However, they found no average statistically significant difference in effect sizes between the two study types. Yet instead of concluding that adequate randomization had no effect the review authors postulated the "unpredictability paradox", which states that randomized and non-randomized studies differ, but in an unpredictable direction. However, stipulating the unpredictability paradox is problematic for several reasons: 1) it makes the authors' conclusion that adequate randomization makes a difference unfalsifiable-if it turned out that adequately randomized trials had significantly different average results from inadequately randomized trials the authors could have pooled the results and concluded that adequate randomization protected against bias; 2) it leaves other authors of reviews with similar results confused about whether or not to pool results (and hence which conclusions to draw); 3) it discourages researchers from investigating the conditions under which adequate randomization over- or under-exaggerates apparent treatment benefits; and 4) it could obscure the relative importance of allocation concealment and blinding which may be more important than adequate randomization.

  • 3.
    Isaksson, Eva
    et al.
    Karolinska Inst, Dept Clin Neurosci, Neurol, Nobels Vag 6, SE-17176 Stockholm, Sweden..
    Wester, Per
    Danderyd Hosp, Karolinska Inst, Dept Clin Sci, SE-18288 Stockholm, Sweden.;Umea Univ, Dept Publ Hlth & Clin Med, S-90187 Umea, Sweden..
    Laska, Ann Charlotte
    Danderyd Hosp, Karolinska Inst, Dept Clin Sci, SE-18288 Stockholm, Sweden..
    Näsman, Per
    KTH, Skolan för arkitektur och samhällsbyggnad (ABE), Fastigheter och byggande, Bygg- och fastighetsekonomi. Center for Safety Research.
    Lundström, Erik
    Uppsala Univ, Dept Clin Neurosci, Neurol, SE-75185 Uppsala, Sweden..
    Identifying important barriers to recruitment of patients in randomised clinical studies using a questionnaire for study personnel2019Ingår i: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 20, nr 1, artikel-id 618Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Background: Many randomised controlled trials (RCT) fail to meet their recruitment goals. Study personnel play a key role in recruitment. The aim of this study was to identify successful strategies that study personnel consider to be important in patient recruitment to RCT. Methods: We constructed a questionnaire based on the literature, discussions with colleagues and our own experience as trialists. The survey was named "What is Important for Making a Study Successful questionnaire" (WIMSS-q). Our target group was the study personnel in the ongoing EFFECTS study. The questionnaire was sent out electronically to all physicians and nurses (n = 148). Success factors and barriers were divided according to patient, centre and study level, respectively. Results: Responses were received from 94% of the study personnel (139/148). The five most important factors at centre level for enhancing recruitment were that the research question was important (97%), a simple procedure for providing information and gaining consent (92%), a highly engaged local principal investigator and research nurse (both 87%), and that study-related follow-ups are practically feasible and possible to coordinate with the clinical follow-up (87%). The most significant barrier at the local centre was lack of time and resources devoted to research (72%). Important patient-related barriers were fear of side effects (35%) and language problems (30%). Conclusions: For recruitment in an RCT to be successful, the research question must be relevant, and the protocol must be simple and easy to implement in the daily routine.

  • 4. Lundstrom, Erik
    et al.
    Isaksson, Eva
    Wester, Per
    Laska, Ann-Charlotte
    Näsman, Per
    KTH.
    Enhancing Recruitment Using Teleconference and Commitment Contract (ERUTECC): study protocol for a randomised, stepped-wedge cluster trial within the EFFECTS trial2018Ingår i: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 19, artikel-id 14Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Background: Many randomised controlled trials (RCTs) fail to meet their recruitment goals in time. Trialists are advised to include study recruitment strategies within their trials. EFFECTS is a Swedish, academic-led RCT of fluoxetine for stroke recovery. The trial's primary objective is to investigate whether 20 mg fluoxetine daily compared with placebo for 6 months after an acute stroke improves the patient's functional outcome. The first patient was included on 20 October 2014 and, as of 31 August 2017, EFFECTS has included 810 of planned 1500 individuals. EFFECTS currently has 32 active centres. The primary objective of the ERUTECC (Enhancing Recruitment Using Teleconference and Commitment Contract) study is to investigate whether a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% at 60 days post intervention, compared with 60 days pre-intervention, in an ongoing RCT. Methods: ERUTECC is a randomised, stepped-wedge cluster trial embedded in EFFECTS. The plan is to start ERUTECC with a running-in period of September 2017. The first intervention is due in October 2017, and the study will continue for 12 months. We are planning to intervene at all active centres in EFFECTS, except the five top recruiting centres (n=27). The rationale for not intervening at the top recruiting centres is that we believe they have reached their full potential and the intervention would be too weak for them. The hypothesis of this study is that a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% 60 days post intervention, compared to 60 days pre-intervention, in an ongoing RCT. Discussion: EFFECTS is a large, pragmatic RCT of stroke in Sweden. Results from the embedded ERUTECC study could probably be generalised to high-income Western countries, and is relevant to trial management and could improve trial management in the future. It might also be useful in clinical settings outside the field of stroke.

  • 5. Moore, S. A.
    et al.
    Da Silva, R.
    Balaam, Madeline
    Newcastle University, United Kingdom.
    Brkic, L.
    Jackson, D.
    Jamieson, D.
    Ploetz, T.
    Rodgers, H.
    Shaw, L.
    van Wijck, F.
    Price, C.
    Wristband Accelerometers to motiVate arm Exercise after Stroke (WAVES): Study protocol for a pilot randomized controlled trial2016Ingår i: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 17, nr 1, artikel-id 508Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Background: Loss of upper limb function affects up to 85 % of acute stroke patients. Recovery of upper limb function requires regular intensive practise of specific upper limb tasks. To enhance intensity of practice interventions are being developed to encourage patients to undertake self-directed exercise practice. Most interventions do not translate well into everyday activities and stroke patients continue to find it difficult remembering integration of upper limb movements into daily activities. A wrist-worn device has been developed that monitors and provides 'live' upper limb activity feedback to remind patients to use their stroke arm in daily activities (The CueS wristband). The aim of this trial is to assess the feasibility of a multi-centre, observer blind, pilot randomised controlled trial of the CueS wristband in clinical stroke services. Methods/design: This pilot randomised controlled feasibility trial aims to recruit 60 participants over 15 months from North East England. Participants will be within 3 months of stroke which has caused new reduced upper limb function and will still be receiving therapy. Each participant will be randomised to an intervention or control group. Intervention participants will wear a CueS wristband (between 8 am and 8 pm) providing "live" feedback towards pre-set movement goals through a simple visual display and vibration prompts whilst undertaking a 4-week upper limb therapy programme (reviewed twice weekly by an occupational/physiotherapist). Control participants will also complete the 4-week upper limb therapy programme but will wear a 'sham' CueS wristband that monitors upper limb activity but provides no feedback. Outcomes will determine study feasibility in terms of recruitment, retention, adverse events, adherence and collection of descriptive clinical and accelerometer motor performance data at baseline, 4 weeks and 8 weeks. Discussion: The WAVES study will address an important gap in the evidence base by reporting the feasibility of undertaking an evaluation of emerging and affordable technology to encourage impaired upper limb activity after stroke. The study will establish whether the study protocol can be supported by clinical stroke services, thereby informing the design of a future multi-centre randomised controlled trial of clinical and cost-effectiveness.

  • 6. Rowbotham, S. E.
    et al.
    Pinchbeck, J. L.
    Anderson, G.
    Bourke, B.
    Bourke, M.
    Gasser, T. Christian
    KTH, Skolan för teknikvetenskap (SCI), Hållfasthetslära (Inst.).
    Jaeggi, R.
    Jenkins, J. S.
    Moran, C. S.
    Morton, S. K.
    Reid, C. M.
    Velu, R.
    Yip, L.
    Moxon, J. V.
    Golledge, J.
    Inositol in the MAnaGemENt of abdominal aortic aneurysm (IMAGEN): Study protocol for a randomised controlled trial2017Ingår i: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 18, nr 1, artikel-id 547Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Background: An abdominal aortic aneurysm (AAA) is a focal dilation of the abdominal aorta and is associated with a risk of fatal rupture. Experimental studies suggest that myo-inositol may exert beneficial effects on AAAs through favourable changes to biological pathways implicated in AAA pathology. The aim of the Inositol in the MAnaGemENt of abdominal aortic aneurysm (IMAGEN) trial is to assess if myo-inositol will reduce AAA growth. Methods/design: IMAGEN is a multi-centre, prospective, parallel-group, randomised, double-blind, placebo-controlled trial. A total of 164 participants with an AAA measuring ≥ 30 mm will be randomised to either 2 g of myo-inositol or identical placebo twice daily for 12 months. The primary outcome measure will be AAA growth estimated by increase in total infrarenal aortic volume measured on computed tomographic scans. Secondary outcome measures will include AAA diameter assessed by computed tomography and ultrasound, AAA peak wall stress and peak wall rupture index, serum lipids, circulating AAA biomarkers, circulating RNAs and health-related quality of life. All analysis will be based on the intention-to-treat principle at the time of randomisation. All patients who meet the eligibility criteria, provide written informed consent and are enrolled in the study will be included in the primary analysis, regardless of adherence to dietary allocation. Discussion: Currently, there is no known medical therapy to limit AAA progression. The IMAGEN trial will be the first randomised trial, to our knowledge, to assess the value of myo-inositol in limiting AAA growth.

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