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This practical paper explains how to design an randomised controlled trial (RCT) for those who have little prior knowledge of the topic. It covers the basics of radomisation, statistical testing, sample size caluclations, bias and the role of Clinical Trial Units.
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Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Proyectos de Investigación , Sesgo , Humanos , Distribución Aleatoria , Tamaño de la Muestra , Estadística como Asunto/métodosRESUMEN
BACKGROUND: The efficacy of cognitive stimulation therapy (CST) has been demonstrated, but little is known about the characteristics of people with dementia, which may predict a more positive response to CST. This study sought to investigate which factors may predict response to CST. METHODS: Two hundred and seventy-two participants with dementia took part in a 7-week CST intervention. Assessments were carried out pre-treatment and post-treatment. The results were compared with those of a previous comparable CST randomised control trial. A comparison of mean scores pre-CST and post-CST groups was undertaken, and contributing factors that predicted change in outcomes were examined. RESULTS: CST improved cognition and quality of life, and the results showed that the benefits of CST were independent of whether people were taking acetylcholinesteraseinhibitor (AChEI) medication. Increasing age was associated with cognitive benefits, as was female gender. Care home residents improved more than community residents on quality of life, but the community sample seemed to benefit more in relation to behaviour problems. CONCLUSIONS: These results demonstrate that CST improves cognition and quality of life for people with dementia including those already on AChEIs. Older age and being female were associated with increased cognitive benefits from the intervention. Consideration should be given to aspects of CST, which may enhance the benefits for people with dementia who are male and those younger than 80 years.
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Terapia Cognitivo-Conductual/métodos , Demencia/terapia , Factores de Edad , Anciano , Anciano de 80 o más Años , Cognición/fisiología , Demencia/fisiopatología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Calidad de Vida , Factores SexualesRESUMEN
OBJECTIVES: The aim of the REMiniscence groups for people with dementia and their family CAREgivers (REMCARE) study was to assess the effectiveness and cost-effectiveness of joint reminiscence groups for people with dementia and their family caregivers as compared with usual care. DESIGN: A multicentre, pragmatic randomised controlled trial with two parallel arms - an intervention group and a usual-care control group - was carried out. A restricted dynamic method of randomisation was used with an overall allocation ratio of 1 : 1, restricted to ensure intervention groups of a viable size. Assessments, blind to treatment allocation, were carried out at baseline, 3 months and 10 months (primary end point). SETTING: Most participants were recruited through NHS Memory Clinics and Community Mental Health Teams for older people. Assessments were usually carried out in the person's home, and treatment groups were held in a variety of community settings. PARTICIPANTS: A total of 488 individuals (mean age 77.5 years) with mild to moderate dementia (meeting Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition criteria), who were initially living in the community, and who had a relative or other caregiver maintaining regular contact, who could act as an informant and was willing and able to participate in the intervention, were recruited to the study. Most carers were spouses (71%). A total of 350 dyads completed the study. INTERVENTIONS: The intervention consisted of joint reminiscence groups held weekly for 12 consecutive weeks, followed by monthly maintenance sessions for a further 7 months. The sessions followed a treatment manual, and were led by two trained facilitators in each centre, supported by a number of volunteers. Up to 12 dyads were invited to attend each group. MAIN OUTCOME MEASURES: The primary outcome measures were self-reported quality of life for the person with dementia and psychological distress for the carer [General Health Questionnaire-28 item version (GHQ-28)]. Secondary outcome measures included autobiographical memory and activities of daily living for the person with dementia, carer stress for the carer and mood, relationship quality and service use and costs for both parties. RESULTS: The intention-to-treat analysis identified no differences in outcome between the intervention and control conditions on primary or secondary outcomes [self-reported quality of life in Alzheimer's disease: mean difference 0.07, standard error (SE) 0.65; F = 0.48; p = 0.53]. Carers of people with dementia allocated to the reminiscence intervention reported a significant increase in anxiety on a subscale of the GHQ-28 at the 10-month end point (mean difference 1.25, SE 0.5; F = 8.28; p = 0.04). Compliance analyses suggested some benefits for people with dementia who attended more reminiscence sessions; however, carers attending more groups showed increased caregiving stress. Use of health- and social-care services was modest, with no significant difference in service use between conditions. Owing to negligible difference in quality-adjusted life-year gains (derived from European Quality of Life-5 Dimensions) between the conditions the planned full economic analysis was curtailed. CONCLUSIONS: This trial does not provide support for the effectiveness or cost-effectiveness of joint reminiscence groups for people with dementia and their carers. Although there may be some beneficial effects for people with dementia who attend sessions as planned, this must be viewed in the context of raised anxiety and stress in their carers. The reasons for these discrepant outcomes need to be explored further, and may necessitate reappraisal of the movement towards joint interventions. TRIAL REGISTRATION: Current Controlled Trials ISRCTN42430123. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 48. See the HTA programme website for further project information.
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Cuidadores/psicología , Demencia/enfermería , Recuerdo Mental , Evaluación de Resultado en la Atención de Salud , Psicoterapia de Grupo/economía , Psicoterapia de Grupo/métodos , Adulto , Anciano , Anciano de 80 o más Años , Análisis Costo-Beneficio , Femenino , Humanos , Masculino , Persona de Mediana Edad , Distribución por Sexo , Encuestas y Cuestionarios , Reino Unido , Adulto JovenRESUMEN
A flexible, generalized method of treatment allocation is proposed. The method uses a set of controlling parameters that enables the generic algorithm to produce a family of possible outcomes ranging from simple randomization to deterministic allocation. The method controls balance at stratum level, stratification level and overall without detriment to the predictability of the method. The paper lists the desirable characteristics of allocation methods and shows that the proposed method fulfils the majority and is easy to use in the clinical context, once the coding has been established. An explanation of the method for 2, 3 and 4 treatment group allocations is given. Simulations demonstrate the flexibility of the method.