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  • 1
    Online Resource
    Online Resource
    Use of methods for specifying the target difference in randomised controlled trial sample size calculations: Two surveys of trialists’ practice
    SAGE Publications ; 2014
    In:  Clinical Trials Vol. 11, No. 3 ( 2014-06), p. 300-308
    Details
    In: Clinical Trials, SAGE Publications, Vol. 11, No. 3 ( 2014-06), p. 300-308
    Abstract: Central to the design of a randomised controlled trial (RCT) is a calculation of the number of participants needed. This is typically achieved by specifying a target difference, which enables the trial to identify a difference of a particular magnitude should one exist. Seven methods have been proposed for formally determining what the target difference should be. However, in practice, it may be driven by convenience or some other informal basis. It is unclear how aware the trialist community is of these formal methods or whether they are used. Purpose To determine current practice regarding the specification of the target difference by surveying trialists. Methods Two surveys were conducted: (1) Members of the Society for Clinical Trials (SCT): participants were invited to complete an online survey through the society’s email distribution list. Respondents were asked about their awareness, use of, and willingness to recommend methods; (2) Leading UK- and Ireland-based trialists: the survey was sent to UK Clinical Research Collaboration registered Clinical Trials Units, Medical Research Council UK Hubs for Trial Methodology Research, and the Research Design Services of the National Institute for Health Research. This survey also included questions about the most recent trial developed by the respondent’s group. Results Survey 1: Of the 1182 members on the SCT membership email distribution list, 180 responses were received (15%). Awareness of methods ranged from 69 (38%) for health economic methods to 162 (90%) for pilot study. Willingness to recommend among those who had used a particular method ranged from 56% for the opinion-seeking method to 89% for the review of evidence-base method. Survey 2: Of the 61 surveys sent out, 34 (56%) responses were received. Awareness of methods ranged from 33 (97%) for the review of evidence-base and pilot methods to 14 (41%) for the distribution method. The highest level of willingness to recommend among users was for the anchor method (87%). Based upon the most recent trial, the target difference was usually one viewed as important by a stakeholder group, mostly also viewed as a realistic difference given the interventions under evaluation, and sometimes one that led to an achievable sample size. Limitations The response rates achieved were relatively low despite the surveys being short, well presented, and having utilised reminders. Conclusion Substantial variations in practice exist with awareness, use, and willingness to recommend methods varying substantially. The findings support the view that sample size calculation is a more complex process than would appear to be the case from trial reports and protocols. Guidance on approaches for sample size estimation may increase both awareness and use of appropriate formal methods.
    Type of Medium: Online Resource
    ISSN: 1740-7745 , 1740-7753
    URL: Article
    DOI: 10.1177/1740774514521907
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2014
    detail.hit.zdb_id: 2159773-X
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  • 2
    Online Resource
    Online Resource
    Safety and efficacy of fluoxetine on functional outcome after acute stroke (AFFINITY): a randomised, double-blind, placebo-controlled trial
    Elsevier BV ; 2020
    In:  The Lancet Neurology Vol. 19, No. 8 ( 2020-08), p. 651-660
    Details
    In: The Lancet Neurology, Elsevier BV, Vol. 19, No. 8 ( 2020-08), p. 651-660
    Type of Medium: Online Resource
    ISSN: 1474-4422
    URL: Article
    DOI: 10.1016/S1474-4422(20)30207-6
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2020
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  • 3
    Online Resource
    Online Resource
    Twelve-Month Outcomes of the AFFINITY Trial of Fluoxetine for Functional Recovery After Acute Stroke: AFFINITY Trial Steering Committee on Behalf of the AFFINITY Trial Collaboration
    Ovid Technologies (Wolters Kluwer Health) ; 2021
    In:  Stroke Vol. 52, No. 8 ( 2021-08), p. 2502-2509
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 52, No. 8 ( 2021-08), p. 2502-2509
    Abstract: The AFFINITY trial (Assessment of Fluoxetine in Stroke Recovery) reported that oral fluoxetine 20 mg daily for 6 months after acute stroke did not improve functional outcome and increased the risk of falls, bone fractures, and seizures. After trial medication was ceased at 6 months, survivors were followed to 12 months post-randomization. This preplanned secondary analysis aimed to determine any sustained or delayed effects of fluoxetine at 12 months post-randomization. Methods: AFFINITY was a randomized, parallel-group, double-blind, placebo-controlled trial in adults (n=1280) with a clinical diagnosis of stroke in the previous 2 to 15 days and persisting neurological deficit who were recruited at 43 hospital stroke units in Australia (n=29), New Zealand (4), and Vietnam (10) between 2013 and 2019. Participants were randomized to oral fluoxetine 20 mg once daily (n=642) or matching placebo (n=638) for 6 months and followed until 12 months after randomization. The primary outcome was function, measured by the modified Rankin Scale, at 6 months. Secondary outcomes for these analyses included measures of the modified Rankin Scale, mood, cognition, overall health status, fatigue, health-related quality of life, and safety at 12 months. Results: Adherence to trial medication was for a mean 167 (SD 48) days and similar between randomized groups. At 12 months, the distribution of modified Rankin Scale categories was similar in the fluoxetine and placebo groups (adjusted common odds ratio, 0.93 [95% CI, 0.76–1.14]; P =0.46). Compared with placebo, patients allocated fluoxetine had fewer recurrent ischemic strokes (14 [2.18%] versus 29 [4.55%] ; P =0.02), and no longer had significantly more falls (27 [4.21%] versus 15 [2.35%] ; P =0.08), bone fractures (23 [3.58%] versus 11 [1.72%] ; P =0.05), or seizures (11 [1.71%] versus 8 [1.25%] ; P =0.64) at 12 months. Conclusions: Fluoxetine 20 mg daily for 6 months after acute stroke had no delayed or sustained effect on functional outcome, falls, bone fractures, or seizures at 12 months poststroke. The lower rate of recurrent ischemic stroke in the fluoxetine group is most likely a chance finding. Registration: URL: http://www.anzctr.org.au/ ; Unique identifier: ACTRN12611000774921.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.120.033070
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 1467823-8
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  • 4
    Online Resource
    Online Resource
    Endemic Human Coronavirus Antibody Levels Are Unchanged after Convalescent or Control Plasma Transfusion for Early Outpatient COVID-19 Treatment
    American Society for Microbiology ; 2023
    In:  mBio Vol. 14, No. 1 ( 2023-02-28)
    Details
    In: mBio, American Society for Microbiology, Vol. 14, No. 1 ( 2023-02-28)
    Abstract: The impact of preexisting antibodies to the four endemic human coronaviruses (ehCoV) (229E, OC43, NL63, and HKU1) on severe (hospitalization) coronavirus disease 2019 (COVID-19) outcomes has been described in small cohorts. Many studies have measured ehCoV 229E, OC43, NL63, and HKU1 antibody levels weeks after recovery rather than in the first weeks of illness, which is more relevant to early hospitalizations. Antibody levels to the spike protein of the four coronaviruses (229E, OC43, NL63, and HKU1), as well as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), were measured both before and immediately after convalescent or control plasma transfusion in 51 participants who were hospitalized and 250 who were not hospitalized, as well as in 71 convalescent and 50 control plasma donors as a subset from a completed randomized controlled trial. In COVID-19 convalescent plasma donors, the ehCoV spike antibodies were 1.2 to 2 times greater than the control donor unit levels, while donor COVID-19 convalescent plasma (CCP) SARS-CoV-2 spike antibodies were more than 600 times the control plasma units. Plasma transfusion, whether COVID-19 convalescent or control, did not alter the post-transfusion antibody levels for the endemic human coronaviruses (229E, OC43, NL63, and HKU1) in those hospitalized and not hospitalized, despite the 1.2- to 2-fold elevation in donor COVID-19 convalescent plasma. There was no influence of prior antibody levels to 229E, OC43, NL63, and HKU1 or post-transfusion antibody levels on subsequent hospitalization. These data, from a well-controlled prospective randomized clinical trial, add evidence that antibodies to ehCoV do not significantly impact COVID-19 outcomes, despite the apparent back-boosting of some ehCoV after SARS-CoV-2 infection. IMPORTANCE The relevance of preexisting immunity to the four endemic human coronaviruses in the first week of COVID-19 illness on the outcome of COVID-19 progression stems from the high prevalence of the ehCoV and SARS-CoV-2 coronaviruses. The question has been raised of whether therapeutic convalescent plasma or control plasma containing ehCoV antibodies might alter the outcome of COVID-19 progression to hospitalization. Here, we observed that plasma transfusion did not significantly change the preexisting ehCoV antibody levels. In over 50 hospitalized participants and 250 nonhospitalized participants, ehCoV antibody levels were comparable, without statistical differences. Antibody levels were stable over the more than 12 months of the intervention trial, with individual heterogeneity similar in hospitalized and nonhospitalized participants. The ehCoV antibodies in plasma transfusion did not alter the recipient preexisting antibody levels nor hasten the COVID-19 progression to hospitalization in this clinical trial data.
    Type of Medium: Online Resource
    ISSN: 2150-7511
    URL: Article
    DOI: 10.1128/mbio.03287-22
    Language: English
    Publisher: American Society for Microbiology
    Publication Date: 2023
    detail.hit.zdb_id: 2557172-2
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  • 5
    Online Resource
    Online Resource
    Distinct cognitive phenotypes in Alzheimer's disease in older people
    Cambridge University Press (CUP) ; 2013
    In:  International Psychogeriatrics Vol. 25, No. 10 ( 2013-10), p. 1659-1666
    Details
    In: International Psychogeriatrics, Cambridge University Press (CUP), Vol. 25, No. 10 ( 2013-10), p. 1659-1666
    Abstract: Alzheimer's disease (AD) is considered to be a disorder predominantly affecting memory. It is increasingly recognized that the cognitive profile may be heterogeneous. We hypothesized that it would be possible to define distinct “cognitive phenotypes” in older people with AD. Methods: Participants from three individual studies were included, consisting of 109 patients with a diagnosis of probable AD, and 91 age- and gender-matched control participants. All had demographic and cognitive assessment data available, including the Cambridge Cognitive Examination of the Elderly (CAMCOG). The CAMCOG scores and sub-scores were further analyzed using hierarchical cluster analysis and factor analysis. Results: Three clusters were identified. The scores loaded onto three factors representing the domains of attention, praxis, calculation, and perception; memory; and language comprehension and executive function. The main difference between the clusters related to degree of memory impairment. The composite score for memory between the clusters remained significantly different despite adjustment for illness duration and age of onset (p 〈 0.001). Conclusions: These data suggest clinical heterogeneity within an older group of people with AD. This may have implications for diagnosis, prognosis, response to currently available treatments, and the development of novel therapies.
    Type of Medium: Online Resource
    ISSN: 1041-6102 , 1741-203X
    URL: Article
    DOI: 10.1017/S1041610213000914
    Language: English
    Publisher: Cambridge University Press (CUP)
    Publication Date: 2013
    detail.hit.zdb_id: 2147136-8
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  • 6
    Online Resource
    Online Resource
    The 2006 American Association of Feline Practitioners Feline Vaccine Advisory Panel Report
    American Veterinary Medical Association (AVMA) ; 2006
    In:  Journal of the American Veterinary Medical Association Vol. 229, No. 9 ( 2006-11), p. 1405-1441
    Details
    In: Journal of the American Veterinary Medical Association, American Veterinary Medical Association (AVMA), Vol. 229, No. 9 ( 2006-11), p. 1405-1441
    Type of Medium: Online Resource
    ISSN: 0003-1488
    URL: Article
    DOI: 10.2460/javma.229.9.1405
    Language: English
    Publisher: American Veterinary Medical Association (AVMA)
    Publication Date: 2006
    detail.hit.zdb_id: 2904887-4
    SSG: 22
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  • 7
    Online Resource
    Online Resource
    Are We Getting Better at Managing Agitation in Dementia?
    Elsevier BV ; 2020
    In:  The American Journal of Geriatric Psychiatry Vol. 28, No. 4 ( 2020-04), p. 401-403
    Details
    In: The American Journal of Geriatric Psychiatry, Elsevier BV, Vol. 28, No. 4 ( 2020-04), p. 401-403
    Type of Medium: Online Resource
    ISSN: 1064-7481
    URL: Article
    DOI: 10.1016/j.jagp.2019.11.004
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2020
    detail.hit.zdb_id: 1474415-6
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  • 8
    Online Resource
    Online Resource
    Risk of dementia associated with psychotic disorders in later life: the health in men study (HIMS)
    Cambridge University Press (CUP) ; 2019
    In:  Psychological Medicine Vol. 49, No. 2 ( 2019-01), p. 232-242
    Details
    In: Psychological Medicine, Cambridge University Press (CUP), Vol. 49, No. 2 ( 2019-01), p. 232-242
    Abstract: Recent research has identified several potentially modifiable risk factors for dementia, including mental disorders. Psychotic disorders, such as schizophrenia and delusional disorder, have also been associated with increased risk of cognitive impairment and dementia, but currently available data difficult to generalise because of bias and confounding. We designed the present study to investigate if the presence of a psychotic disorder increased the risk of incident dementia in later life. Methods Prospective cohort study of a community-representative sample of 37 770 men aged 65–85 years who were free of dementia at study entry. They were followed for up to 17.7 years using electronic health records. Clinical diagnoses followed the International Classification of Diseases guidelines. As psychotic disorders increase mortality, we considered death a competing risk. Results A total of 8068 (21.4%) men developed dementia and 23 999 (63.5%) died during follow up. The sub-hazard ratio of dementia associated with a psychotic disorder was 2.67 (95% CI 2.30–3.09), after statistical adjustments for age and prevalent cardiovascular, respiratory, gastrointestinal and renal diseases, cancer, as well as hearing loss, depressive and bipolar disorders, and alcohol use disorder. The association between psychotic disorder and dementia risk varied slightly according to the duration of the psychotic disorder (highest for those with the shortest illness duration), but not the age of onset. No information about the use of antipsychotics was available. Conclusion Older men with a psychotic disorder have nearly three times greater risk of developing dementia than those without psychosis. The pathways linking psychotic disorders to dementia remain unclear but may involve mechanisms other than those associated with Alzheimer's disease and other common dementia syndromes.
    Type of Medium: Online Resource
    ISSN: 0033-2917 , 1469-8978
    URL: Article
    DOI: 10.1017/S003329171800065X
    RVK:
    XA 10000
    Language: English
    Publisher: Cambridge University Press (CUP)
    Publication Date: 2019
    detail.hit.zdb_id: 1470300-2
    SSG: 5,2
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  • 9
    Online Resource
    Online Resource
    Insulin Resistance and Depressive Symptoms in Older Men: The Health in Men Study
    Elsevier BV ; 2015
    In:  The American Journal of Geriatric Psychiatry Vol. 23, No. 8 ( 2015-08), p. 872-880
    Details
    In: The American Journal of Geriatric Psychiatry, Elsevier BV, Vol. 23, No. 8 ( 2015-08), p. 872-880
    Type of Medium: Online Resource
    ISSN: 1064-7481
    URL: Article
    DOI: 10.1016/j.jagp.2014.10.010
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2015
    detail.hit.zdb_id: 1474415-6
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  • 10
    Online Resource
    Online Resource
    Effect of B Vitamins and Lowering Homocysteine on Cognitive Impairment in Patients With Previous Stroke or Transient Ischemic Attack : A Prespecified Secondary Analysis of a Randomized, Placebo-Controlled Trial and Meta-Analysis
    Ovid Technologies (Wolters Kluwer Health) ; 2013
    In:  Stroke Vol. 44, No. 8 ( 2013-08), p. 2232-2239
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 44, No. 8 ( 2013-08), p. 2232-2239
    Abstract: High plasma total homocysteine (tHcy) has been associated with cognitive impairment but lowering tHcy with B-vitamins has produced equivocal results. We aimed to determine whether B-vitamin supplementation would reduce tHcy and the incidence of new cognitive impairment among individuals with stroke or transient ischemic attack ≥6 months previously. Methods— A total of 8164 patients with stroke or transient ischemic attack were randomly allocated to double-blind treatment with one tablet daily of B-vitamins (folic acid, 2 mg; vitamin B6, 25 mg; vitamin B12, 500 μg) or placebo and followed up for 3.4 years (median) in the VITAmins TO Prevent Stroke (VITATOPS) trial. For this prespecified secondary analysis of VITATOPS, the primary outcome was a new diagnosis of cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score 〈 24 on ≥2 follow-up visits. Secondary outcomes were cognitive decline, and the mean tHcy and MMSE at final follow-up. Results— A total of 3089 participants (38%) voluntarily undertook the MMSE 〉 6 months after the qualifying stroke; 2608 participants were cognitively unimpaired (MMSE ≥24), of whom 2214 participants (1110 B-vitamins versus 1104 placebo) had follow-up MMSEs during 2.8 years (median). At final follow-up, allocation to B-vitamins, compared with placebo, was associated with a reduction in mean tHcy (10.2 μmol/L versus 14.2 μmol/L; P 〈 0.001) but no change from baseline in the mean MMSE score (−0.22 points versus −0.25 points; difference, 0.03; 95% confidence interval, −0.13 to 0.19; P =0.726) and no difference in the incidence of cognitive impairment (5.51% versus 5.47%; risk ratio, 1.01; 95% confidence interval, 0.69–1.48; P =0.976), cognitive decline (9.1% versus 10.3%; risk ratio, 0.89; 0.67–1.18; P =0.414), or cognitive impairment or decline (11.0% versus 11.3%; risk ratio, 0.98; 0.75–1.27; P =0.855). Conclusions— Daily supplementation with folic acid, vitamin B6, and vitamin B12 to a self-selected clinical trial cohort of cognitively unimpaired patients with previous stroke or transient ischemic attack lowered mean tHcy but had no effect on the incidence of cognitive impairment or cognitive decline, as measured by the MMSE, during a median of 2.8 years. Clinical Trial Registration— URL: http://www.controlled-trials.com . Unique identifier: ISRCTN74743444; URL: http://www.clinicaltrials.gov . Unique identifier: NCT00097669.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.113.001886
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2013
    detail.hit.zdb_id: 1467823-8
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