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1.
Psychother Psychosom ; 84(5): 304-13, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26278784

RESUMO

BACKGROUND: DIALOG+ was developed as a computer-mediated intervention, consisting of a structured assessment of patients' concerns combined with a solution-focused approach to initiate change. This study tested the effectiveness of DIALOG+ in the community treatment of patients with psychosis. METHOD: This was a pragmatic, exploratory, parallel-group, cluster-randomised controlled trial. Clinicians within community teams - along with patients with psychosis under their care - were randomised to use DIALOG+ once per month for 6 months or an active control. The primary outcome (subjective quality of life, SQOL) and secondary outcomes were assessed after 3, 6 and 12 months by blinded assessors and analysed using mixed-effect models. RESULTS: A total of 49 clinicians and 179 patients were randomised. Implementation of DIALOG+ was variable, with an average of 1.8 sessions (SD = 1.6) in the first 3 months and 1.1 (SD = 1.2) in the following 3 months. Patients in the DIALOG+ arm had better SQOL at 3, 6 and 12 months (p = 0.035, 0.058 and 0.014, respectively; Cohen's d = 0.29-0.34). They also had significantly fewer unmet needs at 3 and 6 months, fewer general psychopathological symptoms at all time points and better objective social outcomes at 12 months, with no significant differences in other outcomes. Overall care costs were lower in the intervention group. CONCLUSION: Despite variable implementation, DIALOG+ is a beneficial intervention for community patients with psychosis. As a non-expensive and potentially cost-saving, generic intervention, DIALOG+ may be widely used and may improve the effectiveness of community treatment. Further trials should test DIALOG+ in different patient groups and contexts.


Assuntos
Transtornos Psicóticos/terapia , Terapia Assistida por Computador/métodos , Adulto , Idoso , Análise por Conglomerados , Serviços Comunitários de Saúde Mental/economia , Análise Custo-Benefício , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Assistência Centrada no Paciente , Qualidade de Vida , Esquizofrenia/terapia , Terapia Assistida por Computador/economia , Adulto Jovem
2.
Int J Epidemiol ; 44(3): 1051-67, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-26174515

RESUMO

BACKGROUND: The use of cluster randomized trials (CRTs) is increasing, along with the variety in their design and analysis. The simplest approach for their sample size calculation is to calculate the sample size assuming individual randomization and inflate this by a design effect to account for randomization by cluster. The assumptions of a simple design effect may not always be met; alternative or more complicated approaches are required. METHODS: We summarise a wide range of sample size methods available for cluster randomized trials. For those familiar with sample size calculations for individually randomized trials but with less experience in the clustered case, this manuscript provides formulae for a wide range of scenarios with associated explanation and recommendations. For those with more experience, comprehensive summaries are provided that allow quick identification of methods for a given design, outcome and analysis method. RESULTS: We present first those methods applicable to the simplest two-arm, parallel group, completely randomized design followed by methods that incorporate deviations from this design such as: variability in cluster sizes; attrition; non-compliance; or the inclusion of baseline covariates or repeated measures. The paper concludes with methods for alternative designs. CONCLUSIONS: There is a large amount of methodology available for sample size calculations in CRTs. This paper gives the most comprehensive description of published methodology for sample size calculation and provides an important resource for those designing these trials.


Assuntos
Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Tamanho da Amostra , Humanos , Cooperação do Paciente
4.
J Clin Epidemiol ; 68(6): 716-23, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25523375

RESUMO

OBJECTIVES: To assess the quality of reporting and accuracy of a priori estimates used in sample size calculations for cluster randomized trials (CRTs). STUDY DESIGN AND SETTING: We reviewed 300 CRTs published between 2000 and 2008. The prevalence of reporting sample size elements from the 2004 CONSORT recommendations was evaluated and a priori estimates compared with those observed in the trial. RESULTS: Of the 300 trials, 166 (55%) reported a sample size calculation. Only 36 of 166 (22%) reported all recommended descriptive elements. Elements specific to CRTs were the worst reported: a measure of within-cluster correlation was specified in only 58 of 166 (35%). Only 18 of 166 articles (11%) reported both a priori and observed within-cluster correlation values. Except in two cases, observed within-cluster correlation values were either close to or less than a priori values. CONCLUSION: Even with the CONSORT extension for cluster randomization, the reporting of sample size elements specific to these trials remains below that necessary for transparent reporting. Journal editors and peer reviewers should implement stricter requirements for authors to follow CONSORT recommendations. Authors should report observed and a priori within-cluster correlation values to enable comparisons between these over a wider range of trials.


Assuntos
Análise por Conglomerados , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Relatório de Pesquisa , Tamanho da Amostra , Interpretação Estatística de Dados , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Projetos de Pesquisa
5.
Lancet Respir Med ; 2(10): 796-803, 2014 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-25212745

RESUMO

BACKGROUND: The effectiveness of intermittent montelukast for wheeze in young children is unclear. We aimed to assess whether intermittent montelukast is better than placebo for treatment of wheeze in this age group. Because copy numbers of the Sp1-binding motif in the arachidonate 5-lipoxygenase (ALOX5) gene promoter (either 5/5, 5/x, or x/x, where x does not equal 5) modifies response to montelukast in adults, we stratified by this genotype. METHODS: We did this multicentre, parallel-group, randomised, placebo-controlled trial between Oct 1, 2010, and Dec 20, 2013, at 21 primary care sites and 41 secondary care sites in England and Scotland. Children aged 10 months to 5 years with two or more wheeze episodes were allocated to either a 5/5 or 5/x+x/x ALOX5 promoter genotype stratum, then randomly assigned (1:1) via a permuted block schedule (size ten), to receive intermittent montelukast or placebo given by parents at each wheeze episode over a 12 month period. Clinical investigators and parents were masked to treatment group and genotype strata. The primary outcome was number of unscheduled medical attendances for wheezing episodes. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01142505. FINDINGS: We randomly assigned 1358 children to receive montelukast (n=669) or placebo (n=677). Consent was withdrawn for 12 (1%) children. Primary outcome data were available for 1308 (96%) children. There was no difference in unscheduled medical attendances for wheezing episodes between children in the montelukast and placebo groups (mean 2·0 [SD 2·6] vs 2·3 [2·7]; incidence rate ratio [IRR] 0·88, 95% CI: 0·77-1·01; p=0·06). Compared with placebo, unscheduled medical attendances for wheezing episodes were reduced in children given montelukast in the 5/5 stratum (2·0 [2·7] vs 2·4 [3·0]; IRR 0·80, 95% CI 0·68-0·95; p=0·01), but not in those in the 5/x+x/x stratum (2·0 [2·5] vs 2·0 [2·3]; 1·03, 0·83-1·29; p=0·79, pinteraction=0·08). We recorded one serious adverse event, which was a skin reaction in a child allocated to placebo. INTERPRETATION: Our findings show no clear benefit of intermittent montelukast in young children with wheeze. However, the 5/5 ALOX5 promoter genotype might identify a montelukast-responsive subgroup. FUNDING: Medical Research Council (UK) and National Institute for Health Research.


Assuntos
Acetatos/uso terapêutico , Antiasmáticos/uso terapêutico , Asma/tratamento farmacológico , Quinolinas/uso terapêutico , Sons Respiratórios/efeitos dos fármacos , Acetatos/administração & dosagem , Agendamento de Consultas , Araquidonato 5-Lipoxigenase/efeitos dos fármacos , Pré-Escolar , Ciclopropanos , Cisteína/urina , Esquema de Medicação , Feminino , Genótipo , Humanos , Lactente , Leucotrienos/urina , Masculino , Quinolinas/administração & dosagem , Sulfetos , Resultado do Tratamento
6.
BMC Psychiatry ; 14: 51, 2014 Feb 21.
Artigo em Inglês | MEDLINE | ID: mdl-24555511

RESUMO

BACKGROUND: The NOURISHED study: Nice OUtcomes for Referrals with Impulsivity, Self Harm and Eating Disorders.Eating Disorders (ED) and Borderline Personality Disorder (BPD) are both difficult to treat and the combination presents particular challenges. Both are associated with vulnerability to loss of mentalization (awareness of one's own and others' emotional state). In BPD, Mentalization Based therapy (MBT) has been found effective in reducing symptoms. In this trial we investigate the effectiveness and cost-effectiveness of MBT adapted for Eating disorders (Mentalization Based Therapy for Eating Disorders (MBT-ED)) compared to a standard comparison treatment, Specialist Supportive Clinical Management (SSCM-ED) in patients with a combination of an Eating Disorder and either a diagnosis of BPD or a history of self-harm and impulsivity in the previous 12 months. METHODS/DESIGN: We will complete a multi-site single-blind randomized controlled trial (RCT) of MBT-ED vs SSCM-ED. Participants will be recruited from three Eating Disorder Services and two Borderline Personality Disorder Services in London. Participants allocated to MBT-ED will receive one year of weekly group and individual therapy and participants allocated to SSCM-ED will receive 20 sessions of individual therapy over 1 year. In addition, participants in both groups will have access to up to 5 hours of dietetic advice. The primary outcome measure is the global score on the Eating Disorders Examination. Secondary outcome measures include total score on the Zanarini BPD scale, the Object Relations Inventory, the Depression Anxiety Stress Scales, quality of life and cost-effectiveness. Measures are taken at recruitment and at 6 month intervals up to 18 months. DISCUSSION: This is the first Randomised Controlled Trial of MBT-ED in patients with eating disorders and symptoms of BPD and will provide evidence to inform therapy decisions in this group of patients. During MBT-ED mentalization is encouraged, while in SSCM-ED it is not overtly addressed. This study will help elucidate mechanisms of change in the two therapies and analysis of therapy and interview transcripts will provide qualitative information about the conduct of therapy and changes in mentalization and object relations. TRIAL REGISTRATION: ISRCTN51304415.


Assuntos
Transtorno da Personalidade Borderline/terapia , Transtornos da Alimentação e da Ingestão de Alimentos/terapia , Psicoterapia/métodos , Teoria da Mente , Adulto , Transtorno da Personalidade Borderline/complicações , Análise Custo-Benefício , Transtornos da Alimentação e da Ingestão de Alimentos/complicações , Feminino , Humanos , Londres , Masculino , Qualidade de Vida , Comportamento Autodestrutivo/psicologia , Método Simples-Cego , Resultado do Tratamento
7.
J Allergy Clin Immunol ; 133(1): 225-32.e1-5, 2014 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-23806636

RESUMO

BACKGROUND: Alcohol consumption in western pregnant women is not uncommon and could be a risk factor for childhood atopic disease. However, reported alcohol intake may be unreliable, and associations are likely to be confounded. OBJECTIVE: We aimed to study the relation between prenatal alcohol exposure and atopic phenotypes in a large population-based birth cohort with the use of a Mendelian randomization approach to minimize bias and confounding. METHODS: In white mothers and children in the Avon Longitudinal Study of Parents and Children (ALSPAC) we first analyzed associations between reported maternal alcohol consumption during pregnancy and atopic outcomes in the offspring measured at 7 years of age (asthma, wheezing, hay fever, eczema, atopy, and total IgE). We then analyzed the relation of maternal alcohol dehydrogenase (ADH)1B genotype (rs1229984) with these outcomes (the A allele is associated with faster metabolism and reduced alcohol consumption and, among drinkers, would be expected to reduce fetal exposure to ethanol). RESULTS: After controlling for confounders, reported maternal drinking in late pregnancy was negatively associated with childhood asthma and hay fever (adjusted odds ratio [OR] per category increase in intake: 0.91 [95% CI, 0.82-1.01] and 0.87 [95% CI, 0.78-0.98], respectively). However, maternal ADH1B genotype was not associated with asthma comparing carriers of A allele with persons homozygous for G allele (OR, 0.98 [95% CI, 0.66-1.47]) or hay fever (OR, 1.11 [95% CI, 0.71-1.72]), nor with any other atopic outcome. CONCLUSION: We have found no evidence to suggest that prenatal alcohol exposure increases the risk of asthma or atopy in childhood.


Assuntos
Álcool Desidrogenase/genética , Consumo de Bebidas Alcoólicas/epidemiologia , Asma/epidemiologia , Dermatite Atópica/epidemiologia , Eczema/genética , Efeitos Tardios da Exposição Pré-Natal/genética , Adulto , Consumo de Bebidas Alcoólicas/genética , Asma/genética , Criança , Estudos de Coortes , Dermatite Atópica/genética , Eczema/epidemiologia , Feminino , Genótipo , Humanos , Análise da Randomização Mendeliana , Polimorfismo Genético , Gravidez , Rinite Alérgica Sazonal/epidemiologia , Rinite Alérgica Sazonal/genética , Risco , Fatores Socioeconômicos , Reino Unido , População Branca/genética , Adulto Jovem
8.
BMC Psychiatry ; 13: 173, 2013 Jun 26.
Artigo em Inglês | MEDLINE | ID: mdl-23802602

RESUMO

BACKGROUND: Large numbers of patients with psychosis have regular meetings with key clinicians in the community. There is little evidence on how these meetings should be conducted to be therapeutically effective. DIALOG, a computer mediated procedure, was shown to improve outcomes in a European multi-centre trial. DIALOG structures the patient-clinician communication and makes it patient-centred, but does not guide clinicians as to how to respond to patients' concerns. DIALOG has been further developed into DIALOG+, which uses advanced software and, additionally, provides a four step approach--based on a solution focused model--for addressing patients' concerns. We designed a cluster randomised controlled trial to test the effectiveness of DIALOG+ in improving treatment outcomes of patients with psychosis in the community. METHODS/DESIGN: Key workers are recruited from community mental health teams in East London and randomly allocated to either the intervention or control group. Out of their case loads, we identify patients with schizophrenia (F 20-29) and a moderate or lower level of subjective quality of life (MANSA score <5), who are treated according to the allocation of their key workers. Key workers in the intervention group are trained in using DIALOG+ and use it with each patient over a six-month period. Control patients rate their satisfaction with life and treatment on a tablet to control for the effect of regular ratings and the use of modern technology. We are recruiting up to 42 key workers to reach a total sample size of 180 patients. Clinical and social outcomes including costs are assessed after 3, 6 and 12 months. Primary outcome is subjective quality-of-life at 6 months. DISCUSSION: The trial aims to evaluate the effectiveness of a novel intervention (DIALOG+) which uses modern technology to support routine patient-clinician meetings in community care, makes the communication patient centred and guides patients and clinicians to address concerns. DIALOG+ is a generic and widely applicable intervention. If shown as effective, it can be used to improve outcomes of community care on a large scale, ensuring that routine encounters are therapeutically effective. DIALOG+ can also be implemented across services at relatively low additional costs. TRIAL REGISTRATION: Current Controlled Trials ISRCTN34757603.


Assuntos
Comunicação , Serviços Comunitários de Saúde Mental/métodos , Relações Médico-Paciente , Transtornos Psicóticos/terapia , Esquizofrenia/terapia , Adolescente , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Transtornos Psicóticos/psicologia , Resultado do Tratamento
9.
Br J Gen Pract ; 62(602): e647-55, 2012 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-22947586

RESUMO

BACKGROUND: Domestic violence affects one in four women and has significant health consequences. Women experiencing abuse identify doctors and other health professionals as potential sources of support. Primary care clinicians agree that domestic violence is a healthcare issue but have been reluctant to ask women if they are experiencing abuse. AIM: To measure selected UK primary care clinicians' current levels of knowledge, attitudes, and clinical skills in this area. DESIGN AND SETTING: Prospective observational cohort in 48 general practices from Hackney in London and Bristol, UK. METHOD: Administration of the Physician Readiness to Manage Intimate Partner Violence Survey (PREMIS), comprising five sections: responder profile, background (perceived preparation and knowledge), actual knowledge, opinions, and practice issues. RESULTS: Two hundred and seventy-two (59%) clinicians responded. Minimal previous domestic violence training was reported by participants. Clinicians only had basic knowledge about domestic violence but expressed a positive attitude towards engaging with women experiencing abuse. Many clinicians felt poorly prepared to ask relevant questions about domestic violence or to make appropriate referrals if abuse was disclosed. Forty per cent of participants never or seldom asked about abuse when a woman presented with injuries. Eighty per cent said that they did not have an adequate knowledge of local domestic violence resources. GPs were better prepared and more knowledgeable than practice nurses; they also identified a higher number of domestic violence cases. CONCLUSION: Primary care clinicians' attitudes towards women experiencing domestic violence are generally positive but they only have basic knowledge of the area. Both GPs and practice nurses need more comprehensive training on assessment and intervention, including the availability of local domestic violence services.


Assuntos
Competência Clínica/normas , Medicina Geral/normas , Conhecimentos, Atitudes e Prática em Saúde , Profissionais de Enfermagem/normas , Maus-Tratos Conjugais/prevenção & controle , Adulto , Comunicação , Estudos Transversais , Inglaterra , Feminino , Medicina Geral/educação , Humanos , Masculino , Anamnese/normas , Profissionais de Enfermagem/educação , Relações Enfermeiro-Paciente , Percepção , Relações Médico-Paciente , Padrões de Prática Médica , Autoeficácia
10.
Lancet ; 378(9805): 1788-95, 2011 Nov 19.
Artigo em Inglês | MEDLINE | ID: mdl-22000683

RESUMO

BACKGROUND: Most clinicians have no training about domestic violence, fail to identify patients experiencing abuse, and are uncertain about management after disclosure. We tested the effectiveness of a programme of training and support in primary health-care practices to increase identification of women experiencing domestic violence and their referral to specialist advocacy services. METHODS: In this cluster randomised controlled trial, we selected general practices in two urban primary care trusts, Hackney (London) and Bristol, UK. Practices in which investigators from this trial were employed or those who did not use electronic records were excluded. Practices were stratified by proportion of female doctors, postgraduate training status, number of patients registered, and percentage of practice population on low incomes. Within every primary care trust area, we randomised practices with a computer-minimisation programme with a random component to intervention or control groups. The intervention programme included practice-based training sessions, a prompt within the medical record to ask about abuse, and a referral pathway to a named domestic violence advocate, who also delivered the training and further consultancy. The primary outcome was recorded referral of patients to domestic violence advocacy services. The prespecified secondary outcome was recorded identification of domestic violence in the electronic medical records of the general practice. Poisson regression analyses accounting for clustering were done for all practices receiving the intervention. Practice staff and research associates were not masked and patients were not aware they were part of a study. This study is registered at Current Controlled Trials, ISRCTN74012786. FINDINGS: We randomised 51 (61%) of 84 eligible general practices in Hackney and Bristol. Of these, 24 received a training and support programme, 24 did not receive the programme, and three dropped out before the trial started. 1 year after the second training session, the 24 intervention practices recorded 223 referrals of patients to advocacy and the 24 control practices recorded 12 referrals (adjusted intervention rate ratio 22·1 [95% CI 11·5-42·4]). Intervention practices recorded 641 disclosures of domestic violence and control practices recorded 236 (adjusted intervention rate ratio 3·1 [95% CI 2·2-4·3). No adverse events were recorded. INTERPRETATION: A training and support programme targeted at primary care clinicians and administrative staff improved referral to specialist domestic violence agencies and recorded identification of women experiencing domestic violence. Our findings reduce the uncertainty about the benefit of training and support interventions in primary care settings for domestic violence and show that screening of women patients for domestic violence is not a necessary condition for improved identification and referral to advocacy services. FUNDING: Health Foundation.


Assuntos
Violência Doméstica/prevenção & controle , Educação Médica Continuada , Atenção Primária à Saúde , Encaminhamento e Consulta , Análise por Conglomerados , Feminino , Medicina Geral/educação , Humanos , Avaliação de Processos e Resultados em Cuidados de Saúde , Reino Unido
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