RESUMO
This notice describes a correction to the above mentioned paper.
RESUMO
BackgroundKetamine has recently become an agent of interest as an acute treatment for severe depression and as the anaesthetic for electroconvulsive therapy (ECT). Subanaesthetic doses result in an acute reduction in depression severity while evidence is equivocal for this antidepressant effect with anaesthetic or adjuvant doses. Recent systematic reviews call for high-quality evidence from further randomised controlled trials (RCTs).AimsTo establish if ketamine as the anaesthetic for ECT results in fewer ECT treatments, improvements in depression severity ratings and less memory impairment than the standard anaesthetic.MethodDouble-blind, parallel-design, RCT of intravenous ketamine (up to 2 mg/kg) with an active comparator, intravenous propofol (up to 2.5 mg/kg), as the anaesthetic for ECT in patients receiving ECT for major depression on an informal basis. (Trial registration: European Clinical Trials Database (EudraCT): 2011-000396-14 and clinicalTrials.gov: NCT01306760)ResultsNo significant differences were found on any outcome measure during, at the end of or 1 month following the ECT course.ConclusionsKetamine as an anaesthetic does not enhance the efficacy of ECT.
Assuntos
Eletroconvulsoterapia , Ketamina/uso terapêutico , Adolescente , Adulto , Idoso , Anestésicos/uso terapêutico , Antidepressivos/uso terapêutico , Terapia Combinada , Transtorno Depressivo Maior/tratamento farmacológico , Transtorno Depressivo Maior/terapia , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Propofol/uso terapêutico , Resultado do Tratamento , Adulto JovemRESUMO
OBJECTIVE: The study aimed to explore cognitive outcomes after electroconvulsive therapy (ECT) depending on which version of common single nucleotide polymorphisms the patient expressed for brain-derived neurotrophic factor (BDNF) and catechol-O-methyltransferase (COMT). METHODS: A total of 87 patients from the clinical ECT service in Aberdeen, Scotland, were included in the study. Cognitive function testing (using Spatial Recognition Memory task from the Cambridge Neuropsychological Test Automated Battery and Mini-Mental State Examination) and mood ratings (Montgomery-Åsberg Depression Rating Scale) were performed before ECT, after 4 treatments, at the end of ECT and 1 and 3 months after the end of treatment. These scores were compared depending on BDNF and COMT variant at each time point using the Student t test and using a time series generalized least squares random effects model. RESULTS: No differences were found between the val and met versions of the BDNF or COMT polymorphism in either cognitive or mood outcomes at any time point during ECT treatment or up to 3 months of follow-up. CONCLUSIONS: This study did not detect significant differences in cognitive or mood outcomes between patients who have the val66val or met versions of the BDNF polymorphism. Our results suggest that these polymorphisms will not be helpful in clinical practice for predicting cognitive outcomes after ECT.
Assuntos
Fator Neurotrófico Derivado do Encéfalo/genética , Catecol O-Metiltransferase/genética , Cognição , Transtorno Depressivo Maior/genética , Transtorno Depressivo Maior/terapia , Eletroconvulsoterapia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Transtorno Depressivo Maior/psicologia , Feminino , Genótipo , Humanos , Masculino , Pessoa de Meia-Idade , Testes Neuropsicológicos , Polimorfismo Genético , Escalas de Graduação Psiquiátrica , Resultado do Tratamento , Adulto JovemRESUMO
OBJECTIVE: To assess the relationship between electrical stimulation administered to patients undergoing bilateral electroconvulsive therapy (ECT) and subsequent measures of cognitive function and depression severity. METHODS: Stimulus dose titrated patients receiving bilateral ECT were assessed with the Cambridge Neuropsychological Test Automated Battery (CANTAB) Spatial Recognition Memory test and Montgomery Asberg Depression Rating Scale (MADRS) at baseline, after 4 ECT treatments and on course completion. Changes in CANTAB and MADRS scores were assessed in relation to electrical dosage, initial stimulus dose, and demographic variables using linear mixed models. RESULTS: Data pertained to 143 patients (mean age, 56.85 [SD, 14.94], 43% male). Median change in CANTAB score was -10% (-20% to 5%) after 4 ECT treatments and -10% (-20% to 5%) at course completion. Median change in MADRS score was -22 (-33 to -13) after 4 ECT treatments and -14 (-25 to -7) at course completion. Electrical dosage had no effect on CANTAB or MADRS change scores either after 4 treatments or course completion. Improvement in CANTAB score at end of course was associated with female sex (P < 0.05), higher intelligence quotient (P = 0.01), and age. After 4 treatments, improvement in CANTAB score was associated with younger age (P < 0.001) and higher intelligence quotient (P < 0.01). Improved MADRS score at course completion was associated with older age (P < 0.001 at end of course and after 4 treatments). CONCLUSIONS: Electroconvulsive therapy has significant antidepressant and cognitive effects which are not associated with the total electrical dose administered. Other, unalterable variables, such as age and sex, have an influence on these effects.
Assuntos
Cognição , Transtorno Depressivo Maior/psicologia , Transtorno Depressivo Maior/terapia , Eletroconvulsoterapia/métodos , Eletroconvulsoterapia/psicologia , Adulto , Fatores Etários , Idoso , Relação Dose-Resposta à Radiação , Feminino , Humanos , Testes de Inteligência , Masculino , Pessoa de Meia-Idade , Testes Neuropsicológicos , Escalas de Graduação Psiquiátrica , Caracteres Sexuais , Resultado do TratamentoRESUMO
OBJECTIVE: This study aimed to explore the relationship of Montgomery-Åsberg Depression Rating Scale (MADRS) symptom subtypes with response to electroconvulsive therapy (ECT) and subsequent ECT treatment within 12 months. METHODS: A consecutive sample of 414 patients with depression receiving ECT in the North East of Scotland was assessed by retrospective chart review. Response rate was defined as greater than or equal to 50% decrease in pretreatment total MADRS score or a posttreatment total MADRS less than or equal to 10. Principal component analyses were conducted on a sample with psychotic features (n = 124) and a sample without psychotic features (n = 290). Scores on extracted factor subscales, clinical and demographic characteristics were assessed for association with response and subsequent ECT treatment within 12 months. Where more than 1 variable was associated with response or subsequent ECT, logistic regression analysis was applied. RESULTS: MADRS symptom subtypes formed 3 separate factors in both samples. Logistic regression revealed older age and high "Despondency" subscale score predicted response in the nonpsychotic group. Older age alone predicted response in the group with psychotic features. Nonpsychotic patients subsequently re-treated with ECT were older than those not prescribed subsequent ECT. No association of variables emerged with subsequent ECT treatment in the group with psychotic features. Being of older age and the presence of psychotic features predicted response. Presence of psychotic features alone predicted subsequent retreatment. CONCLUSIONS: Subscale scores of the MADRS are of limited use in predicting which patients with depression will respond to ECT, with the exception of "Despondency" subscale scores in patients without psychotic features.
Assuntos
Transtorno Depressivo Maior/terapia , Eletroconvulsoterapia , Escalas de Graduação Psiquiátrica , Fatores Etários , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Análise de Componente Principal , Estudos Retrospectivos , Fatores de Risco , Escócia , Resultado do TratamentoRESUMO
Aneurysmal subarachnoid haemorrhage (aSAH) is a devastating condition with high mortality and morbidity. The outcome measures used in aSAH clinical research vary making it challenging to compare and combine different studies. Additionally, there may be a mismatch between the outcomes prioritized by patients, caregivers, and health care providers and those selected by researchers. We conducted an international, online, multiple round Delphi study to develop consensus on domains (where a domain is a health concept or aspect) prioritized by key stakeholders including those with lived experience of aSAH, health care providers, and researchers, funders, or industry professionals. One hundred seventy-five people participated in the survey, 59% of whom had lived experience of aSAH. Over three rounds, 32 domains reached the consensus threshold pre-defined as 70% of participants rating the domain as being critically important. During the fourth round, participants ranked the importance of each of these 32 domains. The top ten domains ranked highest to lowest were (1) Cognition and executive function, (2) Aneurysm obliteration, (3) Cerebral infarction, (4) Functional outcomes including ability to walk, (5) Delayed cerebral ischemia, (6) The overall quality of life as reported by the SAH survivor, (7) Changes to emotions or mood (including depression), (8) The basic activities of daily living, (9) Vasospasm, and (10) ICU complications. Our findings confirm that there is a mismatch between domains prioritized by stakeholders and outcomes used in clinical research. Our future work aims to address this mismatch through the development of a core outcome set in aSAH research.
RESUMO
OBJECTIVES: Electroconvulsive therapy (ECT) is often given by a specialist ECT team on behalf of a patient's treating psychiatrist. A key aspect of this interface is the communication between these care teams. This study describes the introduction of an ECT treatment report at the Royal Cornhill Hospital in Aberdeen. The aim of the current study was to evaluate whether these reports were useful to psychiatrist. METHODS: The report was designed to provide feedback to the treating psychiatrists on a range cognitive (Mini Mental State Examination, spatial recognition memory on the Cambridge Automated Neuropsychological Testing Battery, Squire Subjective Memory Scale, and Prospective And Retrospective Memory Questionnaire) and mood scores (Montgomery Åsberg Depression Rating Scale) routinely collected by the ECT team. The reports contain the patient's score and the mean of all patients treated in the service. A questionnaire was sent to all treating psychiatrists to evaluate the usefulness of the reports. RESULTS: A 76% response rate was obtained. The reports were well received by treating teams, among whom 78.9% thought they were necessary, 74% thought they were easy to understand, and 79% thought the report was informative. A minority 47.4% thought the report influenced clinical practice, and only 31.3% showed the report to patients. CONCLUSIONS: From the results of our evaluation, the provision of an "ECT Treatment Report" providing a summary of the routinely collected mood and cognitive rating data was useful for psychiatrists prescribing ECT. It is thus likely that such a report would be useful in other ECT services.
Assuntos
Eletroconvulsoterapia/métodos , Comunicação Interdisciplinar , Planejamento de Assistência ao Paciente , Afeto/fisiologia , Humanos , Classificação Internacional de Doenças , Memória/fisiologia , Testes Neuropsicológicos , Pacientes , Escalas de Graduação Psiquiátrica , Psiquiatria , Reconhecimento Psicológico/fisiologia , Encaminhamento e Consulta , Inquéritos e QuestionáriosRESUMO
The question of what processes are involved in the acquisition and representation of categories remains unresolved despite several decades of research. Studies using the well-known prototype distortion task (Posner and Keele in J Exp Psychol 77:353-363, 1968) delineate three candidate models. According to exemplar-based models, we memorize each instance of a category and when asked to decide whether novel items are category members or not, the decision is explicitly based on a similarity comparison with each stored instance. By contrast, prototype models assume that categorization is based on the similarity of the target item to an implicit abstraction of the central tendency or average of previously encountered instances. A third model suggests that the categorization of prototype distortions does not depend on pre-exposure to study exemplars at all and instead reflects properties of the stimuli that are easily learned during the test. The four experiments reported here found evidence that categorization in this task is predicated on the first and third of these models, namely transfer at test and the exemplar-based model. But we found no evidence for the second candidate model that assumed that categorization is based on implicit prototype abstraction.
Assuntos
Aprendizagem/fisiologia , Modelos Neurológicos , Amnésia/psicologia , Conscientização , Formação de Conceito , Intervalos de Confiança , Feminino , Humanos , Masculino , Processos Mentais/fisiologia , Testes Neuropsicológicos , Estimulação Luminosa , Análise de Regressão , Adulto JovemRESUMO
SYNOPSIS: Advanced glaucoma is associated with sight loss. This within-trial economic evaluation compares medical and surgical management strategies. At 2 years, medication appears more cost-effective though longitudinal outcomes are an important subject in future research. BACKGROUND/AIMS: Open angle glaucoma (OAG) is a progressive optic neuropathy. Approximately 25% of newly diagnosed patients with OAG present with advanced disease in at least one eye. The vision loss associated with OAG can lead to significant impacts on vision, quality of life and health care resources. The Treatment of Advanced Glaucoma Study is a randomised controlled trial comparing the effectiveness of primary surgical and medical management for newly diagnosed advanced patients with OAG. An economic evaluation was carried out to understand the costs and benefits of each strategy. METHODS: A cost utility analysis was carried out from a National Health Service perspective over a 2-year time horizon inclusive of patient costs. The primary outcome was patient health-related quality of life measured by the EQ-5D-5L, Health Utilities Index 3 (HUI3) and Glaucoma Utility Index (GUI). Results were expressed as incremental cost per QALY gained. RESULTS: Trabeculectomy was associated with higher costs and greater effect, the EQ-5D-5L results have an incremental cost per QALY of £45,456. The likelihood of surgery being cost-effective at a £20, 000, £30,000 and £50,000 QALY threshold is 0%, 12% and 56%, respectively. The results for the HUI3, GUI and inclusion of patient costs do not change the conclusions of the study. CONCLUSION: This is the first study to evaluate management strategies for those presenting with advanced glaucoma. At a 2-year time horizon, medication is the more cost-effective approach for managing glaucoma. Future research can focus on the costs and benefits of the treatments over a longer time horizon.
RESUMO
OBJECTIVE: To determine whether primary trabeculectomy or primary medical treatment produces better outcomes in term of quality of life, clinical effectiveness, and safety in patients presenting with advanced glaucoma. DESIGN: Pragmatic multicentre randomised controlled trial. SETTING: 27 secondary care glaucoma departments in the UK. PARTICIPANTS: 453 adults presenting with newly diagnosed advanced open angle glaucoma in at least one eye (Hodapp classification) between 3 June 2014 and 31 May 2017. INTERVENTIONS: Mitomycin C augmented trabeculectomy (n=227) and escalating medical management with intraocular pressure reducing drops (n=226) MAIN OUTCOME MEASURES: Primary outcome: vision specific quality of life measured with Visual Function Questionnaire-25 (VFQ-25) at 24 months. SECONDARY OUTCOMES: general health status, glaucoma related quality of life, clinical effectiveness (intraocular pressure, visual field, visual acuity), and safety. RESULTS: At 24 months, the mean VFQ-25 scores in the trabeculectomy and medical arms were 85.4 (SD 13.8) and 84.5 (16.3), respectively (mean difference 1.06, 95% confidence interval -1.32 to 3.43; P=0.38). Mean intraocular pressure was 12.4 (SD 4.7) mm Hg for trabeculectomy and 15.1 (4.8) mm Hg for medical management (mean difference -2.8 (-3.8 to -1.7) mm Hg; P<0.001). Adverse events occurred in 88 (39%) patients in the trabeculectomy arm and 100 (44%) in the medical management arm (relative risk 0.88, 95% confidence interval 0.66 to 1.17; P=0.37). Serious side effects were rare. CONCLUSION: Primary trabeculectomy had similar quality of life and safety outcomes and achieved a lower intraocular pressure compared with primary medication. TRIAL REGISTRATION: Health Technology Assessment (NIHR-HTA) Programme (project number: 12/35/38). ISRCTN registry: ISRCTN56878850.
Assuntos
Glaucoma de Ângulo Aberto/cirurgia , Qualidade de Vida , Trabeculectomia/estatística & dados numéricos , Idoso , Feminino , Glaucoma de Ângulo Aberto/psicologia , Humanos , Pressão Intraocular , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários , Trabeculectomia/psicologia , Reino Unido , Acuidade VisualRESUMO
BACKGROUND: Patients diagnosed with advanced primary open-angle glaucoma are at a high risk of lifetime blindness. Uncertainty exists about whether primary medical management (glaucoma eye drops) or primary surgical treatment (augmented trabeculectomy) provide the best and safest patient outcomes. OBJECTIVES: To compare primary medical management with primary surgical treatment (augmented trabeculectomy) in patients with primary open-angle glaucoma presenting with advanced disease in terms of health-related quality of life, clinical effectiveness, safety and cost-effectiveness. DESIGN: This was a two-arm, parallel, multicentre, pragmatic randomised controlled trial. SETTING: Secondary care eye services. PARTICIPANTS: Adult patients presenting with advanced primary open-angle glaucoma in at least one eye, as defined by the Hodapp-Parrish-Anderson classification of severe glaucoma. INTERVENTION: Primary medical treatment - escalating medical management with glaucoma eye drops. Primary trabeculectomy treatment - trabeculectomy augmented with mitomycin C. MAIN OUTCOME MEASURES: The primary outcome was health-related quality of life measured with the Visual Function Questionnaire-25 at 2 years post randomisation. Secondary outcomes were mean intraocular pressure; EQ-5D-5L; Health Utilities Index 3; Glaucoma Utility Index; cost and cost-effectiveness; generic, vision-specific and disease-specific health-related quality of life; clinical effectiveness; and safety. RESULTS: A total of 453 participants were recruited. The mean age of the participants was 67 years (standard deviation 12 years) in the trabeculectomy arm and 68 years (standard deviation 12 years) in the medical management arm. Over 65% of participants were male and more than 80% were white. At 24 months, the mean difference in Visual Function Questionnaire-25 score was 1.06 (95% confidence interval -1.32 to 3.43; p = 0.383). There was no evidence of a difference between arms in the EQ-5D-5L score, the Health Utilities Index or the Glaucoma Utility Index. At 24 months, the mean intraocular pressure was 12.40 mmHg in the trabeculectomy arm and 15.07 mmHg in the medical management arm (mean difference -2.75 mmHg, 95% confidence interval -3.84 to -1.66 mmHg; p < 0.001). Fewer types of glaucoma eye drops were required in the trabeculectomy arm. LogMAR visual acuity was slightly better in the medical management arm (mean difference 0.07, 95% confidence interval 0.02 to 0.11; p = 0.006) than in the trabeculectomy arm. There was no evidence of difference in safety between the two arms. A discrete choice experiment updated the utility values for the Glaucoma Utility Index. The within-trial economic analysis found a small increase in the mean EQ-5D-5L score (0.04) and that trabeculectomy has a higher probability of being cost-effective than medical management. The incremental cost of trabeculectomy per quality-adjusted life-year was £45,456. Therefore, at 2 years, surgery is unlikely to be considered cost-effective at a threshold of £20,000 per quality-adjusted life-year. When extrapolated over a patient's lifetime in a model-based analysis, trabeculectomy, compared with medical treatment, was associated with higher costs (average £2687), a larger number of quality-adjusted life-years (average 0.28) and higher incremental cost per quality-adjusted life-year gained (average £9679). The likelihood of trabeculectomy being cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life year gained was 73%. CONCLUSIONS: Our results suggested that there was no difference between treatment arms in health-related quality of life, as measured with the Visual Function Questionnaire-25 at 24 months. Intraocular pressure was better controlled in the trabeculectomy arm, and this may reduce visual field progression. Modelling over the patient's lifetime suggests that trabeculectomy may be cost-effective over the range of values of society's willingness to pay for a quality-adjusted life-year. FUTURE WORK: Further follow-up of participants will allow us to estimate the long-term differences of disease progression, patient experience and cost-effectiveness. TRIAL REGISTRATION: Current Controlled Trials ISRCTN56878850. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 72. See the NIHR Journals Library website for further project information.
Glaucoma is an eye condition in which the intraocular pressure is too high, causing damage to the optic nerve and loss of vision. Patients with severe vision loss at diagnosis are the most at risk of blindness in their lifetime. Lowering pressure in the eye is the only way to prevent further vision loss. Two treatments to lower pressure are commonly used: using eye drops or having an operation known as a trabeculectomy. In England, Wales and Northern Ireland, the National Institute for Health and Care Excellence recommends surgery as the first treatment. However, we do not know which treatment is best for preventing vision loss or which is safest, has the best patient experience or provides the best value for money for the NHS. Therefore, surgery is not usually carried out in the first instance and patients start with eye drops instead. This study compared whether starting treatment with eye drops affected the quality of life of patients with advanced glaucoma more or less than starting treatment with trabeculectomy. We also investigated if initial treatment with surgery and initial treatment with eye drops were equally good at controlling pressure and were equally safe, and how much each treatment cost the NHS. Every patient had an equal chance of starting treatment with surgery or eye drops and they participated in the study for 2 years. We found that quality of life was similar regardless of treatment. Those starting with surgery had lower pressure and needed far fewer types of eye drops than those starting with eye drops. Thirty-nine patients in the eye drop arm required surgery to control their glaucoma. Initial treatment with eye drops was cheaper over 2 years' follow-up. Our study suggests that, over a 2-year period, having surgery in the first instance lowers intraocular pressure more than eye drops and is equally as safe as eye drops. Although eye drops are a cheaper treatment option for the NHS, if the effects of surgery on intraocular pressure are lasting, then the increased cost may be justified.
Assuntos
Glaucoma de Ângulo Aberto , Glaucoma , Trabeculectomia , Idoso , Análise Custo-Benefício , Feminino , Glaucoma de Ângulo Aberto/tratamento farmacológico , Glaucoma de Ângulo Aberto/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Soluções Oftálmicas , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de VidaRESUMO
To assess mild head injury effects in adolescent soccer players, neuropsychological performance across school team soccer players, rugby players and noncontact sport players was assessed in a quasi-experimental cross-sectional design. One hundred eighty-five males were tested (ages 13-16; response rate 55%) and 86 contributed data to the analyses after exclusion for recent concussion and overlapping sports participation. Soccer players showed lower premorbid intellectual functioning, but neither soccer players nor rugby players showed neuropsychological decrement compared with noncontact sport players. Cumulative heading did not predict neuropsychological performance. While no specific attribute of soccer was linked with neuropsychological impairment, head injury predicted reduced attention for all participants.
Assuntos
Atenção , Traumatismos Craniocerebrais , Função Executiva , Memória , Futebol/lesões , Adolescente , Análise de Variância , Estudos Transversais , Futebol Americano , Humanos , Masculino , Testes Neuropsicológicos , Reino UnidoRESUMO
PURPOSE: To report the baseline characteristics of participants enrolled in TAGS (Treatment of Advanced Glaucoma Study). DESIGN: Pragmatic randomized control trial (RCT). METHODS: Participants with newly diagnosed advanced glaucoma in at least 1 eye were recruited. Participants were patients with open angle glaucoma presenting with advanced glaucoma in at least 1 eye as defined by the Hodapp-Parrish-Anderson (HPA) criteria for severe defect. Participants were randomly allocated to receive either primary augmented trabeculectomy or primary medical management. When both eyes were eligible, the same intervention was undertaken in both eyes, and the index eye for analysis was the eye with the less severe visual field mean defect (MD). Main outcome measurements were visual field profile, defined by the HPA classification; clinical characteristics; quality of life, as measured by the National Eye Institute Visual Function Questionnaire 25 (VFQ-25), the EuroQual-5 Dimension (EQ-5D 5L), Health Utility Index-3 (HUI-3), and the Glaucoma Profile Instrument (GPI). RESULTS: A total of 453 patients were recruited. The mean visual field MD was -15.0 dB ± 6.3 in the index eye and -6.2 dB in the non-index eye. Of index eyes (HPA "severe" classification) at baseline, more than 70% of participants had a MD <-12.00 dB, and nearly 90% had more than 20 points defective at the 1% level. The mean LogMAR visual acuity of the index eye was 0.2 ± 0.3. CONCLUSIONS: TAGS is the first RCT to compare medical versus surgical treatments for patients presenting with advanced open angle glaucoma in a publicly funded health service. The study will provide clinical, health-related quality of life, and economic outcomes to inform future treatment choices for those presenting with advanced glaucoma.
Assuntos
Anti-Hipertensivos/uso terapêutico , Glaucoma de Ângulo Aberto/diagnóstico , Trabeculectomia/métodos , Idoso , Idoso de 80 Anos ou mais , Feminino , Glaucoma de Ângulo Aberto/fisiopatologia , Glaucoma de Ângulo Aberto/terapia , Humanos , Pressão Intraocular/fisiologia , Masculino , Pessoa de Meia-Idade , Qualidade de Vida/psicologia , Perfil de Impacto da Doença , Transtornos da Visão/fisiopatologia , Acuidade Visual/fisiologia , Campos Visuais/fisiologiaRESUMO
BACKGROUND: Data collection consumes a large proportion of clinical trial resources. Each data item requires time and effort for collection, processing and quality control procedures. In general, more data equals a heavier burden for trial staff and participants. It is also likely to increase costs. Knowing the types of data being collected, and in what proportion, will be helpful to ensure that limited trial resources and participant goodwill are used wisely. AIM: The aim of this study is to categorise the types of data collected across a broad range of trials and assess what proportion of collected data each category represents. METHODS: We developed a standard operating procedure to categorise data into primary outcome, secondary outcome and 15 other categories. We categorised all variables collected on trial data collection forms from 18, mainly publicly funded, randomised superiority trials, including trials of an investigational medicinal product and complex interventions. Categorisation was done independently in pairs: one person having in-depth knowledge of the trial, the other independent of the trial. Disagreement was resolved through reference to the trial protocol and discussion, with the project team being consulted if necessary. KEY RESULTS: Primary outcome data accounted for 5.0% (median)/11.2% (mean) of all data items collected. Secondary outcomes accounted for 39.9% (median)/42.5% (mean) of all data items. Non-outcome data such as participant identifiers and demographic data represented 32.4% (median)/36.5% (mean) of all data items collected. CONCLUSION: A small proportion of the data collected in our sample of 18 trials was related to the primary outcome. Secondary outcomes accounted for eight times the volume of data as the primary outcome. A substantial amount of data collection is not related to trial outcomes. Trialists should work to make sure that the data they collect are only those essential to support the health and treatment decisions of those whom the trial is designed to inform.
Assuntos
Ensaios Clínicos como Assunto/estatística & dados numéricos , Coleta de Dados/classificação , Coleta de Dados/normas , Interpretação Estatística de Dados , HumanosRESUMO
BACKGROUND: Presentation with advanced glaucoma is the major risk factor for lifetime blindness. Effective intervention at diagnosis is expected to minimise risk of further visual loss in this group of patients. AIM: To compare clinical and cost-effectiveness of primary medical management compared with primary surgery for people presenting with advanced open-angle glaucoma (OAG). METHODS: Design: A prospective, pragmatic multicentre randomised controlled trial (RCT). SETTING: Twenty-seven UK hospital eye services. PARTICIPANTS: Four hundred and forty patients presenting with advanced OAG, according to the Hodapp-Parish-Anderson classification of visual field loss. INTERVENTION: Participants will be randomised to medical treatment or augmented trabeculectomy (1:1 allocation minimised by centre and presence of advanced disease in both eyes). MAIN OUTCOME MEASURES: The primary outcome is vision-related quality of life measured by the National Eye Institute-Visual Function Questionnaire-25 at 24 months. Secondary outcomes include generic EQ-5D-5L, Health Utility Index-3 and glaucoma-related health status (Glaucoma Utility Index), patient experience, visual field measured by mean deviation value, logarithm of the mean angle of resolution visual acuity, intraocular pressure, adverse events, standards for driving and eligibility for blind certification. Incremental cost per quality-adjusted life-year (QALY) based on EQ-5D-5L and glaucoma profile instrument will be estimated. RESULTS: The study will report the comparative effectiveness and cost-effectiveness of medical treatment against augmented trabeculectomy in patients presenting with advanced glaucoma in terms of patient-reported health and visual function, clinical outcomes and incremental cost per QALY at 2 years. CONCLUSIONS: Treatment of Advanced Glaucoma Study will be the first RCT reporting outcomes from the perspective of those with advanced glaucoma. TRIAL REGISTRATION NUMBER: ISRCTN56878850, Pre-results.
Assuntos
Anti-Hipertensivos/uso terapêutico , Glaucoma de Ângulo Aberto/tratamento farmacológico , Glaucoma de Ângulo Aberto/cirurgia , Trabeculectomia/métodos , Idoso , Anti-Hipertensivos/economia , Análise Custo-Benefício , Feminino , Glaucoma de Ângulo Aberto/economia , Glaucoma de Ângulo Aberto/fisiopatologia , Nível de Saúde , Humanos , Pressão Intraocular/fisiologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Projetos de Pesquisa , Perfil de Impacto da Doença , Trabeculectomia/economia , Resultado do Tratamento , Acuidade Visual/fisiologia , Campos Visuais/fisiologiaRESUMO
BACKGROUND: The claim that recollection and familiarity based memory processes have distinct retrieval mechanisms is based partly on the observation that masked repetition and semantic priming influence estimates of familiarity derived from know responses but have no effect on estimates of recollection derived from remember responses. Close inspection of the experiments on which this claim is based reveal the effect size to be small, potentially the result of a type-2 error, and/or inflated due to participants not having the opportunity to report guesses. This paper re-evaluates these claims by attempting a partial replication of two such Experiments. METHODS: In Experiment 1 participants made remember, know, and guess responses following primed and unprimed target words. In Experiment 2 participants made sure, unsure, and guess following primed and unprimed target words. RESULTS: In Experiment 1 the repetition priming effect occurred only for guess responses and only for unstudied items. In Experiment 2 the priming effect occurred for both unsure and guess responses, but again only for unstudied items. CONCLUSION: The data are consistent with the view that remembering and knowing do not correspond to confidence ratings; and suggest that contrary to earlier findings, recollection and familiarity do not differ in retrieval mechanisms. As such the effects of repetition priming on subjective reports of remembering should not be cited as evidence for the distinction between recollection and familiarity based memory processes.
RESUMO
BACKGROUND: Despite extensive clinical concern about rates of obesity in patients with schizophrenia, there is little evidence of the extent of this problem at a population level. AIMS: To estimate levels of obesity in a national population sample by comparing patients with schizophrenia with matched controls. METHOD: We calculated levels of obesity for each patient with schizophrenia from the national Primary Care Clinical Informatics Unit database (n=4658) matched with age, gender and neighbourhood controls. RESULTS: We demonstrated a significant increased obesity hazard for the schizophrenia group using Cox regression analysis, with odds ratio (OR) of 1.94 (95% CI 1.81-2.10) (under the assumption of missing body mass index (BMI) indicating non-obesity) and OR=1.68 (95% CI 1.55-1.81) where no assumptions were made for missing BMI data. CONCLUSIONS: People with schizophrenia are at increased risk of being obese compared with controls matched by age, gender and practice attended. Priority should be given to research which aims to reduce weight and increase activity in those with schizophrenia. DECLARATION OF INTEREST: None. COPYRIGHT AND USAGE: © The Royal College of Psychiatrists 2017. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) license.
RESUMO
Footballers run the risk of incurring mild head injury from a variety of sources, including the intentional use of the head to play the ball, known as heading. This paper presents a preliminary exploratory analysis of data collected to examine whether cumulative incidence of mild head injury, or cumulative heading frequency, are related to neuropsychological functioning in male adolescent footballers. In a quasi-experimental cross-sectional design, neuropsychological test scores of school team footballers were compared with those of similarly aged rugby players and noncontact sport players. Cumulative mild head injury incidence was estimated using self-reports, and cumulative heading was estimated using a combination of observation and self-reports. No participants had sustained a head injury within 3 months of testing. There was no relationship between head injury and neuropsychological performance, and there were no decrements in either the footballers or the rugby players in comparison with the noncontact sport players. Within the footballers, cumulative heading did not predict any of the neuropsychological test scores. These findings indicate the absence of neuropsychological impairment arising due to cumulative mild head injury incidence, or cumulative heading. Although these null findings may be reassuring to players, parents, and football organizers, we stress that they are preliminary. Further data is being collected from the same populations to provide more reliable effect estimates.
Assuntos
Traumatismos em Atletas/diagnóstico , Dano Encefálico Crônico/diagnóstico , Traumatismos Cranianos Fechados/diagnóstico , Testes Neuropsicológicos/estatística & dados numéricos , Futebol/lesões , Adolescente , Estudos Transversais , Transtornos Traumáticos Cumulativos/diagnóstico , Humanos , Masculino , Psicometria/estatística & dados numéricos , Valores de ReferênciaRESUMO
The importance of unconscious autonomic activity vs. knowledge in influencing behavior on the Iowa Gambling Task (IGT) has been the subject of debate. The task's developers, Bechara and colleagues, have claimed that behavior on the IGT is influenced by somatic activity and that this activity precedes the emergence of knowledge about the task contingencies sufficient to guide behavior. Since then others have claimed that this knowledge emerges much earlier on the task. However, it has yet to be established whether somatic activity which differentiates between advantageous and disadvantageous choices on the IGT is found before this point. This study describes an experiment to determine whether knowledge sufficient to guide behavior precedes differential autonomic activity or vice versa. This experiment used a computerized version of the IGT, knowledge probes after every 10 trials and skin conductance recording to measure somatic activity. Whereas in previous reports the majority of participants end the task with full conceptual knowledge of the IGT contingencies we found little evidence in support of this conclusion. However, full conceptual knowledge was not critical for advantageous deck selection to occur and most participants had knowledge sufficient to guide behavior after approximately 40 trials. We did not find anticipatory physiological activity sufficient to differentiate between deck types in the period prior to acquiring this knowledge. However, post-punishment physiological activity was found to be larger for the disadvantageous decks in the pre-knowledge period, but only for participants who displayed knowledge. Post-reward physiological activity distinguished between the advantageous and disadvantageous decks across the whole experiment but, again, only in participants who displayed knowledge and then only in later trials following their display of knowledge.