RESUMO
OBJECTIVE: The question of whether depression is associated with worse survival in people with cancer remains unanswered because of methodological criticism of the published research on the topic. We aimed to study the association in a large methodologically robust study. METHODS: We analyzed data on 20,582 patients with breast, colorectal, gynecological, lung, and prostate cancers who had attended cancer outpatient clinics in Scotland, United Kingdom. Patients had completed two-stage screening for major depression as part of their cancer care. These data on depression status were linked to demographic, cancer, and subsequent mortality data from national databases. We estimated the association of major depression with survival for each cancer using Cox regression. We adjusted for potential confounders and interactions between potentially time-varying confounders and the interval between cancer diagnosis and depression screening, and used multiple imputation for missing depression and confounder data. We pooled the cancer-specific results using fixed-effects meta-analysis. RESULTS: Major depression was associated with worse survival for all cancers, with similar adjusted hazard ratios (HRs): breast cancer (HR = 1.42, 95% confidence interval [CI] = 1.15-1.75), colorectal cancer (HR = 1.47, 95% CI = 1.11-1.94), gynecological cancer (HR = 1.36, 95% CI = 1.08-1.71), lung cancer (HR = 1.39, 95% CI = 1.24-1.56), and prostate cancer (HR = 1.76, 95% CI = 1.08-2.85). The pooled HR was 1.41 (95% CI = 1.29-1.54, p < .001, I2 = 0%). These findings were not materially different when we only considered the deaths (90%) that were attributed to cancer. CONCLUSIONS: Major depression is associated with worse survival in patients with common cancers. The mechanisms of this association and the clinical implications require further study.
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Neoplasias da Mama , Transtorno Depressivo Maior , Depressão , Transtorno Depressivo Maior/epidemiologia , Humanos , Masculino , Modelos de Riscos Proporcionais , Reino UnidoRESUMO
BACKGROUND: In a randomised controlled trial, contamination is defined as the receipt of active intervention amongst participants in the control arm. This review assessed the processes leading to contamination, its typical quantity, methods used to mitigate it, and impact of use of cluster randomisation to prevent it on study findings in trials of complex interventions in mental health. METHODS: This is a scoping review of trial design approaches and methods of study conduct to address contamination. Studies included were randomised controlled trials of complex interventions in mental health that described the process leading to, amount of, or solution used to counter contamination. The Medline, Embase, and PsycInfo databases were searched for trials published between 2000 and 2015. Risk of bias was assessed using the Jadad score and domains recommended by Cochrane plus some relevant to cluster randomised trials. RESULTS: Two hundred and thirty-four articles were included in the review. The main processes that led to contamination were health professionals delivering both active and comparator treatments and communication among clinicians and participants from the different trial arms. Twenty-three trials (10%) measured binary treatment receipt in the control arm with median 13% of participants found to be contaminated (IQR 5-33%). The most common design approach for dealing with contamination was the use of cluster randomisation (n = 93). In addition, many researchers used simple trial conduct methods to minimise contamination due to suspected contamination processes, such as organising for each clinician to provide only one treatment and separating trial arms spatially or temporally. There was little evidence for a relationship between cluster randomisation to avoid contamination and size of treatment effect estimate. CONCLUSION: There was some evidence of modest levels of treatment contamination with a large range, although a minority of studies reported the amount of contamination. A limitation was that many trials described the problem in little detail. Overall there is a need for greater measurement and reporting of treatment receipt in the control arm of trials. Researchers should be aware of trial conduct methods that can be used to minimise contamination without resorting to cluster randomisation.
Assuntos
Pesquisa Biomédica/métodos , Controle de Qualidade , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Humanos , Saúde MentalRESUMO
AIM: To assess whether preoperative botulinum neurotoxin A (BoNT-A) affects pain after major hip surgery for children with bilateral cerebral palsy (CP). METHOD: This was a randomized, parallel arms, placebo-contolled trial. Children with hypertonic CP aged 2 to 15 years awaiting bony hip surgery at a tertiary hospital were randomized to receive either BoNT-A or placebo injections into the muscles of the hip on a single occasion immediately before surgery. The primary outcome was the paediatric pain profile (PPP), which was assessed at baseline and weekly for 6 weeks. Treatment allocation was by minimization. Participants, clinicians, and outcome assessors were masked to group assignment. RESULTS: Twenty-seven participants (17 males, 10 females; mean 8y 8mo [SD 3y 9mo], range 3y 4mo-15y 10mo) were allocated to BoNT-A and 27 participants (14 males, 13 females; mean 8y 11mo [SD 3y 5mo], range 4y 1mo-15y 2mo) to placebo. Mean (SD) PPP at 6 weeks for the BoNT-A group (n=24 followed up) was 10.96 (7.22) and for the placebo group (n=26) was 10.04 (8.54) (p=0.69; 95% confidence interval [CI] -4.82, 3.18). There were 16 serious adverse events in total during 6 months of follow-up (n=6 in BoNT-A group). INTERPRETATION: Use of BoNT-A immediately before bony hip surgery for reducing postoperative pain for children with CP was not supported. WHAT THIS PAPER ADDS: Botulinum neurotoxin A (BoNT-A) does not reduce postoperative pain following bony hip surgery. BoNT-A also does not affect postoperative quality of life.
NEUROTÓXINA A BOTULÍNICA PREOPERATORIA PARA NIÑOS CON PARÁLISIS CEREBRAL BILATERAL QUE VAN A SER SOMETIDOS A UNA CIRUGÍA MAYOR DE CADERA: UN ENSAYO ALEATORIO, DOBLE CIEGO, CONTROLADO CON PLACEBO: OBJETIVE: Evaluar si la neurotóxina A botulínica preoperatoria (BoNT-A) afecta el dolor después de una cirugía mayor de cadera en niños con parálisis cerebral bilateral (PC). MÉTODO: Este fue un ensayo aleatorio, con brazos paralelos, controlado con placebo. Los niños con PC hipertónica de 2 a 15 años de edad que esperaban una cirugía de cadera en un hospital terciario se escogieron al azar para recibir inyecciones de BoNT-A o de placebo en los músculos de la cadera una sola administración previa a la cirugía. El resultado primario fue el perfil de dolor pediátrico (PPP, siglas en ingles), que se evaluó al inicio del estudio y semanalmente durante 6 semanas. La asignación del tratamiento fue por minimización. Tanto los participantes, como los clínicos y evaluadores de resultados, eran desconocidos para la asignación de grupo. RESULTADOS: Veintisiete participantes (17 varones y 10 mujeres; medios 8 años 8 meses) [Desviación Estandar SD 3 años 9 meses], rango 3 años 4 meses-15 años 10 meses) se les administro BoNT-A y 27 participantes (14 varones y 13 mujeres; media 8 años 11 meses [SD 3 años 5 meses], rango 4 años 1 mes - 15 años 2 meses) a placebo. La PPP media (SD) a las 6 semanas para el grupo de BoNT-A (n = 24 seguidas) fue de 10,96 (7,22) y para el grupo de placebo (n = 26) fue de 10,04 (8,54) (p = 0,69; intervalo de confianza del 95% [CI, siglas en ingles] -4,82, 3,18). Hubo 16 eventos adversos graves en total durante 6 meses de seguimiento (n = 6 en el grupo BoNT-A). INTERPRETACIÓN: El uso de BoNT-A inmediatamente antes de la cirugía de cadera con el fin de reducir el dolor postoperatorio en niños con PC no fue consistente.
NEUROTOXINA BOTULÍNICA A PRÉ-OPERATÓRIA PARA CRIANÇAS COM PARALISIA CEREBRAL BILATERAL SUBMETIDAS A GRANDE CIRURGIA DE QUADRIL: UM ESTUDO RANDOMIZADO, DUPLO-CEGO, CONTROLADO POR PLACEBO: OBJETIVO: Avaliar se a neurotoxina botulínica tipo A (BTA) pré-operatória A afeta a dor após grande cirurgia de quadril em crianças com paralisia cerebral bilateral (PC). MÉTODO: Este foi um estudo randomizado, com braços paralelos e controlado por placebo. Crianças com PC espástica com idade entre 2 a 15 anos aguardando cirurgia óssea de quadril em um hospital terciário foram randomizadas para receber ou BTA ou injeções de placebo nos músculos do quadril em uma única ocasião imediatamente antes da cirurgia. O desfecho primário foi o perfil de dor pediátrica (PDP), que foi avaliado na linha de base e semanalmente por 6 semanas. A alocação de tratamento foi por minimização. Os participantes, clínicos e avaliadores de resultados foram cegados quanto a atribuição de grupo. RESULTADOS: Vinte e sete participantes (17 homens, 10 mulheres; média de 8 anos e 8 meses [DP 3 anos e 9 meses], com idade entre 3 anos e 4 meses à 15 anos e 10 meses) foram alocados para o grupo BTA e 27 participantes (14 homens, 13 mulheres; média de 8 anos e 11 meses [DP 3 anos e 5 meses], com idade entre 4anos e 1mês à 15anos e 2 meses) foram alocados no grupo placebo. A média (DP) do PDP às 6 semanas para o grupo BTA (n = 24) foi de 10,96 (7,22) e para o grupo placebo (n = 26) foi de 10,04 (8,54) (p = 0,69; intervalo de confiança de 95% [IC] -4,82, 3,18). Houve 16 eventos adversos sérios no total durante 6 meses de acompanhamento (n = 6 no grupo BTA). INTERPRETAÇÃO: O uso da BTA imediatamente antes da cirurgia óssea do quadril para reduzir a dor pós-operatória em crianças com PC não foi apoiado.
Assuntos
Toxinas Botulínicas Tipo A/uso terapêutico , Paralisia Cerebral/cirurgia , Articulação do Quadril/cirurgia , Fármacos Neuromusculares/uso terapêutico , Procedimentos Ortopédicos/métodos , Dor Pós-Operatória/prevenção & controle , Adolescente , Criança , Pré-Escolar , Método Duplo-Cego , Feminino , Humanos , Masculino , Procedimentos Ortopédicos/efeitos adversos , Qualidade de Vida , Resultado do TratamentoRESUMO
BACKGROUND: Acetylcholinesterase inhibitors (AChEIs) and memantine are commonly used in the management of dementia. In routine clinical practice, dementia is often monitored via the Mini-Mental State Examination (MMSE). We conducted a systematic review and meta-analysis of the effects of these drugs on MMSE scores. SUMMARY: Eighty trials were identified. Pooled effect estimates were in favour of both AChEIs and memantine at 6 months. Meta-regression indicated that dementia subtype was a moderator of AChEI treatment effect, with the effect of treatment versus control twice as high for patients with Parkinson disease dementia/ dementia with Lewy bodies (2.11 MMSE points at 6 months) as for patients with Alzheimer disease/vascular dementia (0.91 MMSE points at 6 months). Key Messages: AChEIs demonstrate a modest effect versus control on MMSE scores which is moderated by dementia subtype. For memantine the effect is smaller.
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Doença de Alzheimer/tratamento farmacológico , Inibidores da Colinesterase/farmacologia , Cognição/efeitos dos fármacos , Demência Vascular/tratamento farmacológico , Memantina/farmacologia , Doença de Alzheimer/psicologia , Demência Vascular/psicologia , Dopaminérgicos/farmacologia , Humanos , Resultado do TratamentoRESUMO
BACKGROUND: Competencies in psychological techniques delivered by primary care nurses to support diabetes self-management were compared between the intervention and control arms of a cluster randomised controlled trial as part of a process evaluation. The trial was pragmatic and designed to assess effectiveness. This article addresses the question of whether the care that was delivered in the intervention and control trial arms represented high fidelity treatment and attention control, respectively. METHODS: Twenty-three primary care nurses were either trained in motivational interviewing (MI) and cognitive behavioural therapy (CBT) skills or delivered attention control. Nurses' skills in these treatments were evaluated soon after training (treatment arm) and treatment fidelity was assessed after treatment delivery for sessions midway through regimen (both arms) using the Motivational Interviewing Treatment Integrity (MITI) domains and Behaviour Change Counselling Index (BECCI) based on consultations with 151 participants (45% of those who entered the study). The MITI Global Spirit subscale measured demonstration of MI principles: evocation, collaboration, autonomy/support. RESULTS: After training, median MITI MI-Adherence was 86.2% (IQR 76.9-100%) and mean MITI Empathy was 4.09 (SD 1.04). During delivery of treatment, in the intervention arm mean MITI Spirit was 4.03 (SD 1.05), mean Empathy was 4.23 (SD 0.89), and median Percentage Complex Reflections was 53.8% (IQR 40.0-71.4%). In the attention control arm mean Empathy was 3.40 (SD 0.98) and median Percentage Complex Reflections was 55.6% (IQR 41.9-71.4%). CONCLUSIONS: After MI and CBT skills training, detailed assessment showed that nurses had basic competencies in some psychological techniques. There appeared to be some delivery of elements of psychological treatment by nurses in the control arm. This model of training and delivery of MI and CBT skills integrated into routine nursing care to support diabetes self-management in primary care was not associated with high competency levels in all skills. TRIAL REGISTRATION: ISRCTN75776892 ; date registered: 19/05/2010.
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Competência Clínica , Terapia Cognitivo-Comportamental , Diabetes Mellitus Tipo 2/terapia , Educação Continuada em Enfermagem , Entrevista Motivacional , Enfermagem de Atenção Primária , Adulto , Terapia Cognitivo-Comportamental/educação , Aconselhamento/educação , Feminino , Humanos , Pessoa de Meia-Idade , AutogestãoRESUMO
BACKGROUND: Active family engagement improves outcomes from adolescent inpatient care, but the impact on adult anorexia nervosa is uncertain. AIM: The aim of this study was to describe the 2-year outcome following a pragmatic randomised controlled trial in which a skill training intervention (Experienced Caregivers Helping Others) for carers was added to inpatient care. METHOD: Patient, caregiver and service outcomes were measured for 2 years following discharge from the index inpatient admission. RESULTS: There were small-sized/moderate-sized effects and consistent improvements in all outcomes from both patients and carers in the Experienced Caregivers Helping Others group over 2 years. The marked change in body mass index and carers' time caregiving following inpatient care was sustained. Approximately 20% of cases had further periods of inpatient care. CONCLUSION: In this predominately adult anorexia nervosa sample, enabling carers to provide active support and management skills may improve the benefits in all symptom domains that gradually follow from a period of inpatient care.
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Anorexia Nervosa/terapia , Cuidadores/educação , Pacientes Internados/psicologia , Adolescente , Adulto , Anorexia Nervosa/psicologia , Cuidadores/estatística & dados numéricos , Feminino , Seguimentos , Hospitalização , Humanos , Pacientes Internados/estatística & dados numéricos , Masculino , Resultado do TratamentoRESUMO
BACKGROUND: Teaching people with epilepsy to identify and manage seizure triggers, implement strategies to remember to take antiepileptic drugs, implement precautions to minimize risks during seizures, tell others what to do during a seizure and learn what to do during recovery may lead to better self-management. No teaching programme exists for adults with epilepsy in the United Kingdom although a number of surveys have shown patients want more information. METHODS/DESIGN: This is a multicentre, pragmatic, parallel group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of a two-day Self-Management education for epILEpsy (SMILE (UK)), which was originally developed in Germany (MOSES).Four hundred and twenty eight adult patients who attended specialist epilepsy outpatient clinics at 15 NHS participating sites in the previous 12 months, and who fulfil other eligibility criteria will be randomised to receive the intervention (SMILE (UK) course with treatment as usual- TAU) or to have TAU only (control). The primary outcome is the effect on patient reported quality of life (QoL). Secondary outcomes are seizure frequency and psychological distress (anxiety and depression), perceived impact of epilepsy, adherence to medication, management of adverse effects from medication, and improved self-efficacy in management (mastery/control) of epilepsy.Within the trial there will be a nested qualitative study to explore users' views of the intervention, including barriers to participation and the perceived benefits of the intervention. The cost-effectiveness of the intervention will also be assessed. DISCUSSION: This study will provide quantitative and qualitative evidence of the impact of a structured self management programme on quality of life and other aspects of clinical and cost effectiveness in adults with poorly controlled epilepsy. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN57937389.
Assuntos
Epilepsia/terapia , Educação de Pacientes como Assunto/métodos , Autocuidado/métodos , Análise Custo-Benefício , Humanos , Educação de Pacientes como Assunto/economia , Projetos de Pesquisa , Autocuidado/economiaRESUMO
BACKGROUND: Painful hip displacement is difficult to treat in severe cerebral palsy. Proximal femoral resection (PFR) is an excellent procedure for pain relief but has a high rate of heterotopic ossification (HO). Indomethacin is the gold standard therapy used for prevention in hip and acetabular surgery. There is no evidence of its benefit in this complex patient group. METHODS: Forty-one consecutive patients with severe cerebral palsy underwent 52 primary PFRs for severe pain in 2 pediatric orthopaedic units in London, UK. Twenty-one patients received a prophylactic postoperative dose of indomethacin for the prevention of HO. Notes and radiographs were reviewed independently by 2 orthopaedic trainees. RESULTS: The mean age of patients was 14.3 and 14.8 years in the group administered with and administered without indomethacin, respectively, and mean follow-up was 4.5 and 4.3 years. Five patients in each group developed HO. One patient in the indomethacin group was offered reexcision for HO but declined. Two in the nonindomethacin group were offered reexcision and one accepted and made a good recovery. There was no difference in pain relief between the groups and no correlation between the degree of HO and level of postoperative pain. CONCLUSIONS: This study does not support the use of prophylactic indomethacin in severe cerebral palsy patients undergoing PFR. We also question the importance of HO in the outcome of this procedure. LEVEL OF EVIDENCE: Level III.
Assuntos
Paralisia Cerebral/tratamento farmacológico , Fêmur , Luxação do Quadril/tratamento farmacológico , Indometacina/uso terapêutico , Ossificação Heterotópica/prevenção & controle , Dor/tratamento farmacológico , Adolescente , Anti-Inflamatórios não Esteroides/uso terapêutico , Paralisia Cerebral/diagnóstico por imagem , Paralisia Cerebral/cirurgia , Criança , Feminino , Fêmur/diagnóstico por imagem , Fêmur/cirurgia , Luxação do Quadril/diagnóstico por imagem , Luxação do Quadril/cirurgia , Humanos , Masculino , Ossificação Heterotópica/diagnóstico por imagem , Dor/diagnóstico por imagem , Radiografia , Adulto JovemRESUMO
OBJECTIVE: Intellectual disability liaison nurses in general hospitals could enhance access to high-quality, adapted healthcare and improve outcomes. We aimed to explore associations between the input of intellectual disability liaison nurses and the quality of care in people with intellectual disability who are admitted to hospital. DESIGN: Retrospective analysis of a national dataset of mortality reviews. SETTING: General hospitals in England. PARTICIPANTS: 4742 adults with intellectual disability who died in hospital between 2016 and 2021 and whose deaths were reviewed as part of the Learning from Lives and Deaths mortality review programme. OUTCOME MEASURES: We used logistic regression to compare the sociodemographic and clinical characteristics of those who did, and did not, receive input from an intellectual disability liaison nurse. We explored associations between liaison nurse input, care processes and overall quality of care. RESULTS: One-third of people with intellectual disability who died in hospital in England between 2016 and 2021 had input from an intellectual disability liaison nurse. Intellectual disability liaison nurse input was not evenly distributed across England and was more common in those who died of cancer. Having an intellectual disability liaison nurse involved in an individual's care was associated with increased likelihood of reasonable adjustments being made to care (adjusted OR (aOR) 1.95, 95% CI 1.63 to 2.32) and of best practice being identified (aOR 1.37, 95% CI 1.17 to 1.60) but was not associated with a rating of overall quality of care received (aOR 0.94, 95% CI 0.78 to 1.12). CONCLUSIONS: Intellectual disability liaison nurses see only a minority of people with intellectual disability who are admitted to hospital in England. Increasing the availability of intellectual disability liaison nurses could improve care for this disadvantaged group.
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Hospitais Gerais , Deficiência Intelectual , Humanos , Inglaterra/epidemiologia , Deficiência Intelectual/enfermagem , Deficiência Intelectual/mortalidade , Masculino , Feminino , Pessoa de Meia-Idade , Estudos Retrospectivos , Adulto , Mortalidade Hospitalar , Idoso , Qualidade da Assistência à Saúde , Adulto Jovem , Modelos LogísticosRESUMO
BACKGROUND: Neonatal mortality in India has fallen steadily and was estimated to be 24 per 1000 live births in the year 2017. However, neonatal mortality remains high in rural parts of the country. The Community Health Promotion and Medical Provision and Impact On Neonates (CHAMPION2) trial investigates the effect of a complex health intervention on neonatal mortality in the Satna District of Madhya Pradesh. METHODS/DESIGN: The CHAMPION2 trial forms one part of a cluster-randomised controlled trial with villages (clusters) randomised to receive either a health (CHAMPION2) or education (STRIPES2) intervention. Villages receiving the health intervention are controls for the education intervention and vice versa. The primary outcome is neonatal mortality. The effect of the active intervention on the primary outcome (compared to usual care) will be expressed as a risk ratio, estimated using a generalised estimating equation approach with robust standard errors that take account of clustering at village level. Secondary outcomes include maternal mortality, stillbirths, perinatal deaths, causes of death, health care and knowledge, hospital admissions of enrolled women during pregnancy or in the immediate post-natal care period or of their babies (during the neonatal period), maternal blood transfusions, and the cost effectiveness of the intervention. A total of 196 villages have been randomised and over 34,000 women have been recruited in CHAMPION2. DISCUSSION: This update to the published trial protocol gives a detailed plan for the statistical analysis of the CHAMPION2 trial. TRIAL REGISTRATION: Registry of India: CTRI/2019/05/019296. Registered on 23 May 2019. https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MzExOTg=&Enc=&userName=champion2.
Assuntos
Promoção da Saúde , Mortalidade Infantil , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Índia , Recém-Nascido , Promoção da Saúde/métodos , Feminino , Lactente , Gravidez , Interpretação Estatística de Dados , Serviços de Saúde Comunitária , Mortalidade Materna , Análise Custo-BenefícioRESUMO
BACKGROUND: This update outlines amendments to the CHAMPION2/STRIPES2 cluster randomised trial protocol primarily made due to the COVID-19 pandemic and nationwide lockdown in India in 2020. These amendments were in line with national guidelines for health research during the COVID-19 pandemic. METHODS: We did not change the original trial design, eligibility, and outcomes. Amendments were introduced to minimise the risk of COVID-19 transmission and ensure safety and wellbeing of trial staff, participants, and other villagers. CHAMPION2 intervention: participatory learning and action (PLA) and fixed day service (FDS) meeting were revised to incorporate social distancing and hygiene precautions. During the COVID-19 pandemic, PLA participation was limited to pregnant women and birthing partners. STRIPES2 intervention: before/after-school classes were halted for a period and then modified temporarily (reducing class sizes, and/or changing meeting places) with hygiene and safe distancing practices introduced. DATA COLLECTION: The research team gathered as much information as possible from participants by telephone. If the participant had no telephone or could not be contacted by telephone, data were collected in person. COVID-19 precautions: trial teams were trained on COVID-19 precautions and used personal protective equipment whilst in the villages for trial-related activities. After restarting the trial between June and September 2020 in a phased manner, some trial activities were suspended again in all the trial villages from April to June 2021 due to the second wave of COVID-19 cases and lockdown imposed in Satna, Madhya Pradesh. Trial timelines were also revised, with outcomes measured later than originally planned. TRIAL REGISTRATION: Clinical Trial Registry of India CTRI/2019/05/019296. Registered 23 May 2019. https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MzExOTg=&Enc=&userName=champion2 .
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COVID-19 , Promoção da Saúde , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Índia , COVID-19/prevenção & controle , COVID-19/epidemiologia , Promoção da Saúde/métodos , Recém-Nascido , Feminino , SARS-CoV-2 , Gravidez , Letramento em Saúde , População Rural , AlfabetizaçãoRESUMO
BACKGROUND: Older people admitted to hospital in an emergency often have prolonged inpatient stays that worsen their outcomes, increase health-care costs, and reduce bed availability. Growing evidence suggests that the biopsychosocial complexity of their problems, which include cognitive impairment, depression, anxiety, multiple medical illnesses, and care needs resulting from functional dependency, prolongs hospital stays by making medical treatment less efficient and the planning of post-discharge care more difficult. We aimed to assess the effects of enhancing older inpatients' care with Proactive Integrated Consultation-Liaison Psychiatry (PICLP) in The HOME Study. We have previously described the benefits of PICLP reported by patients and clinicians. In this Article, we report the effectiveness and cost-effectiveness of PICLP-enhanced care, compared with usual care alone, in reducing time in hospital. METHODS: We did a parallel-group, multicentre, randomised controlled trial in 24 medical wards of three English acute general hospitals. Patients were eligible to take part if they were 65 years or older, had been admitted in an emergency, and were expected to remain in hospital for at least 2 days from the time of enrolment. Participants were randomly allocated to PICLP or usual care in a 1:1 ratio by a database software algorithm that used stratification by hospital, sex, and age, and randomly selected block sizes to ensure allocation concealment. PICLP clinicians (consultation-liaison psychiatrists supported by assisting clinicians) made proactive biopsychosocial assessments of patients' problems, then delivered discharge-focused care as integrated members of ward teams. The primary outcome was time spent as an inpatient (during the index admission and any emergency readmissions) in the 30 days post-randomisation. Secondary outcomes were the rate of discharge from hospital for the total length of the index admission; discharge destination; the length of the index admission after random allocation truncated at 30 days; the number of emergency readmissions to hospital, the number of days spent as an inpatient in an acute general hospital, and the rate of death in the year after random allocation; the patient's experience of the hospital stay; their view on the length of the hospital stay; anxiety (Generalized Anxiety Disorder-2); depression (Patient Health Questionnaire-2); cognitive function (Montreal Cognitive Assessment-Telephone version); independent functioning (Barthel Index of Activities of Daily Living); health-related quality of life (five-level EuroQol five-dimension questionnaire); and overall quality of life. Statisticians and data collectors were masked to treatment allocation; participants and ward staff could not be. Analyses were intention-to-treat. The trial had a patient and public involvement panel and was registered with ISRTCN (ISRCTN86120296). FINDINGS: 2744 participants (1399 [51·0%] male and 1345 [49·0%] female) were enrolled between May 2, 2018, and March 5, 2020; 1373 were allocated to PICLP and 1371 to usual care. Participants' mean age was 82·3 years (SD 8·2) and 2565 (93·5%) participants were White. The mean time spent in hospital in the 30 days post-randomisation (analysed for 2710 [98·8%] participants) was 11·37 days (SD 8·74) with PICLP and 11·85 days (SD 9·00) with usual care; adjusted mean difference -0·45 (95% CI -1·11 to 0·21; p=0·18). The only statistically and clinically significant difference in secondary outcomes was the rate of discharge, which was 8.5% higher (rate ratio 1·09 [95% CI 1·00 to 1·17]; p=0·042) with PICLP-a difference most apparent in patients who stayed for more than 2 weeks. Compared with usual care, PICLP was estimated to be modestly cost-saving and cost-effective over 1 and 3, but not 12, months. No intervention-related serious adverse events occurred. INTERPRETATION: This is the first randomised controlled trial of PICLP. PICLP is experienced by older medical inpatients and ward staff as enhancing medical care. It is also likely to be cost-saving in the short-term. Although the trial does not provide strong evidence that PICLP reduces time in hospital, it does support and inform its future development and evaluation. FUNDING: UK National Institute for Health and Care Research.
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Tempo de Internação , Encaminhamento e Consulta , Humanos , Feminino , Masculino , Idoso , Inglaterra , Tempo de Internação/estatística & dados numéricos , Análise Custo-Benefício , Idoso de 80 Anos ou mais , Pacientes Internados/psicologia , Hospitalização , Transtornos Mentais/terapiaRESUMO
OBJECTIVES: To describe the practical experience of delivering a proactive and integrated consultation-liaison (C-L) psychiatry service model (PICLP). PICLP is designed for older medical inpatients and is explicitly biopsychosocial and discharge-focused. In this paper we report: (a) observations on the training of 15 clinicians (seven senior C-L psychiatrists and eight assisting clinicians) to deliver PICLP; (b) the care they provided to 1359 patients; (c) their experiences of working in this new way. METHOD: A mixed methods observational study using quantitative and qualitative data, collected prospectively over two years as part of The HOME Study (a randomized trial comparing PICLP with usual care). RESULTS: The clinicians were successfully trained to deliver PICLP according to the service manual. They proactively assessed all patients and found that most had multiple biopsychosocial problems impeding their timely discharge from hospital. They integrated with ward teams to provide a range of interventions aimed at addressing these problems. Delivering PICLP took a modest amount of clinical time, and the clinicians experienced it as both clinically valuable and professionally rewarding. CONCLUSION: The experience of delivering PICLP highlights the special role that C-L psychiatry clinicians, working in a proactive and integrated way, can play in medical care.
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Pacientes Internados , Psiquiatria , Humanos , Hospitais , Alta do Paciente , Psiquiatria/educação , Encaminhamento e Consulta , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: India has made steady progress in improving rates of primary school enrolment but levels of learning achievement remain low. The Support To Rural India's Public Education System (STRIPES) trial provided evidence that an after-school para-teacher intervention improved numeracy and literacy levels in Telangana, India. The STRIPES2 trial investigates whether such an intervention will have a similar effect on the literacy and numeracy of primary school age children in the Satna District of Madhya Pradesh, India. METHODS/DESIGN: The STRIPES2 trial forms one part of a cluster-randomised controlled trial with villages (clusters) randomised to receive either a health (CHAMPION2) or education (STRIPES2) intervention. Building on the design of the earlier CHAMPION/STRIPES trial, villages receiving the health intervention are controls for the education intervention and vice versa. The primary outcome is a combined literacy and numeracy score. Secondary outcomes include separate scores for literacy and numeracy; caregivers' engagement with child's learning; expenditure on education; enrolment in school; caregiver's report of school attendance and the cost effectiveness of the intervention. Over 7000 primary school age children have been recruited and randomised in STRIPES2. DISCUSSION: This update to the published trial protocol gives a detailed plan for the statistical analysis of the STRIPES 2 trial. TRIAL REGISTRATION: Registry of India: CTRI/2019/05/019296. Registered on 23 May 2019. http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=31198&EncHid=&modid=&compid=%27,%2731198det%27.
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Alfabetização , Instituições Acadêmicas , Criança , Humanos , Escolaridade , Aprendizagem , ÍndiaRESUMO
BACKGROUND: Major depression is found in around ten percent of patients attending cancer clinics. One of the symptoms of major depression, defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM), is "thoughts of death or suicide." To implement depression screening programs for patients with cancer, we need to know the prevalence not only of this broadly defined symptom but also of more specific suicidal thoughts, as only the latter clearly indicates the need for specialist psychiatric assessment and management of suicide risk. METHODS: We analyzed data from a routine 2-stage depression screening program that operated in 3 UK cancer centers, linked with demographic and clinical data obtained from a national cancer registry. We included data on 2217 patients with common cancers and comorbid, interview-diagnosed, major depression. We determined the percentage of patients with (a) the DSM-IV symptom "thoughts of death or suicide" and (b) suicidal thoughts, defined as an affirmative response to the question "have you had thoughts of ending your life?" We investigated the associations of patients' demographic and clinical characteristics with each of these using logistic regression models. RESULTS: We found that 641 of 2217 (29%) of patients had the DSM symptom "thoughts of death or suicide" and 207 of 2217 (9%) had suicidal thoughts. Of the demographic and clinical characteristics that we studied, none had statistically significant associations with having the DSM symptom. Only younger age and primary cancer were associated with having suicidal thoughts. CONCLUSIONS: We found that almost one-third of patients with cancer and comorbid major depression have the DSM symptom "thoughts of death or suicide." However, only a third of the patients with this symptom report suicidal thoughts. These findings suggest that around one in ten patients found by a screening program to have major depression will have suicidal thoughts requiring a psychiatric assessment. The staffing of depression screening programs should be designed with these data in mind.
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Transtorno Depressivo Maior , Neoplasias , Prevenção do Suicídio , Suicídio , Depressão , Transtorno Depressivo Maior/diagnóstico , Transtorno Depressivo Maior/epidemiologia , Detecção Precoce de Câncer , Humanos , Neoplasias/diagnóstico , Neoplasias/epidemiologia , Ideação Suicida , Suicídio/psicologiaRESUMO
OBJECTIVE: Previous studies of depression and anxiety during the year before death have reported different findings. We therefore aimed to study depression and anxiety in patients who had died from cancer and had previously attended cancer clinics. METHODS: We analysed routine data on 4869 deceased patients who had completed the Hospital Anxiety and Depression Scale (HADS) as part of their routine cancer care. The HADS data were linked with demographic, cancer and mortality data from national registries. We used data from all HADS completed in the last year of life to investigate the relationships between mean depression (HADS-D) and anxiety (HADS-A) scores and the percentages of high scores (≥11 on each subscale) and time to death (Analysis 1). This analysis used multivariable linear regression with cubic splines and robust standard errors to allow for multiple HADS from the same patients. We also investigated within-patient changes in scores (Analysis 2) in a subset of patients who had completed more than one HADS. RESULTS: In Analysis 1, modelled mean HADS-D scores increased by around 2.5 and the percentage of high HADS-D scores increased from 13% at six months before death to 30% at one month before death. Changes in HADS-A were smaller and occurred later. In Analysis 2, similar patterns were observed in individual patients' HADS scores. CONCLUSION: Depression should be looked for and treated in patients with cancer and a prognosis of six months or less, in order to maximise the quality of patients' remaining life.
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Depressão , Neoplasias , Ansiedade , Transtornos de Ansiedade , Humanos , Qualidade de VidaRESUMO
OBJECTIVES: To describe the implementation of a collaborative care (CC) screening and treatment program for major depression in people with cancer, found to be effective in clinical trials, into routine outpatient care of a cancer center. METHOD: A mixed-methods observational study guided by the RE-AIM implementation framework using quantitative and qualitative data collected over five years. RESULTS: Program set-up took three years and required more involvement of CC experts than anticipated. Barriers to implementation were uncertainty about whether oncology or psychiatry owned the program and the hospital's organizational complexity. Selecting and training CC team members was a major task. 90% (14,412/16,074) of patients participated in depression screening and 61% (136/224) of those offered treatment attended at least one session. Depression outcomes were similar to trial benchmarks (61%; 78/127 patients had a treatment response). After two years the program obtained long-term funding. Facilitators of implementation were strong trial evidence, effective integration into cancer care and ongoing clinical and managerial support. CONCLUSION: A CC program for major depression, designed for the cancer setting, can be successfully implemented into routine care, but requires time, persistence and involvement of CC experts. Once operating it can be an effective and valued component of medical care.
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Transtorno Depressivo Maior , Neoplasias , Assistência Ambulatorial , Depressão/terapia , Transtorno Depressivo Maior/terapia , Humanos , Programas de Rastreamento , Neoplasias/terapiaRESUMO
BACKGROUND: To inform the future development of consultation-liaison psychiatry services, we need accurate information on the prevalence of psychiatric disorders in the general hospital inpatient setting. Systematic reviews have summarized the literature on specific aspects of this broad topic, but there has been no high-level overview that aggregates their findings and identifies gaps in the relevant literature. OBJECTIVE: We aimed to produce a comprehensive overview of the field, summarizing the research literature on the prevalence of psychiatric disorders (i.e., interview-based psychiatric diagnoses) in general hospital inpatients. We did this using a systematic umbrella review (systematic review of systematic reviews), which is the best and most efficient method for summarizing a broad area of research. METHODS: We searched Ovid Medline, Ovid Embase, Ovid PsycINFO, EBSCO CINAHL, and Scopus from database inception to September 2021 for systematic reviews that provided a pooled prevalence estimate, or prevalence range, for interview-diagnosed psychiatric disorders in general hospital inpatients. Two reviewers independently assessed articles and extracted data. The review is registered with PROSPERO, number CRD42019125574. RESULTS: We screened 11,728 articles and included 10 systematic reviews in our umbrella review. We were able to extract pooled prevalence estimates from these as follows: major depression 12% to 20%, any anxiety disorder 8%, generalized anxiety disorder 5%, panic disorder 3%, delirium 15%. We were only able to extract a prevalence range for dementia, which was 3% to 63%. We found no systematic reviews from which we could extract prevalence data for the other psychiatric disorders that we included in our searches, indicating important gaps. From these data, we estimated that approximately one-third of inpatients have a psychiatric disorder. CONCLUSIONS: Psychiatric disorders are very common in general hospital inpatients. While the planning of consultation-liaison psychiatry services will benefit from more research on the prevalence of each of the full range of disorders encountered in the inpatient setting, our findings indicate that we already know enough to justify increased and more population-based service provision.
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Pacientes Internados , Transtornos Mentais , Humanos , Hospitais Gerais , Transtornos Mentais/epidemiologia , Prevalência , Revisões Sistemáticas como AssuntoRESUMO
OBJECTIVE: To determine the prevalence of anxiety in general hospital inpatients by conducting a systematic review and meta-analysis of all relevant published studies. METHOD: We searched Ovid Medline, Ovid Embase and Ovid PsycINFO from inception to December 2020. We included studies of the prevalence of anxiety symptoms of clinically significant severity (using cut-off scores on rating scales) and of the prevalence of anxiety disorders (using diagnostic interviews) in general hospital inpatients. Two independent reviewers assessed articles and extracted data. The review is registered with PROSPERO, number CRD42020189722. RESULTS: We included 32 studies. Pooled prevalence estimates in random-effects meta-analyses were: anxiety symptoms 28% (95% CI 19% to 38%, 95% prediction interval 5% to 72%), any anxiety disorder 8% (95% CI 5% to 12%, 95% prediction interval 2% to 33%), panic disorder 3% (95% CI 2% to 4%, 95% prediction interval 1% to 8%), generalized anxiety disorder 5% (95% CI 3% to 8%, 95% prediction interval 1% to 23%). There was high heterogeneity in prevalence, little of which was explained in exploratory analyses of a limited number of potential determinants. CONCLUSION: Anxiety symptoms of clinically significant severity affect more than one in four inpatients and anxiety disorders affect nearly one in ten.
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Hospitais Gerais , Pacientes Internados , Ansiedade/epidemiologia , Transtornos de Ansiedade/epidemiologia , Humanos , PrevalênciaRESUMO
OBJECTIVES: To determine, for doctors looking after older medical inpatients: (1) how difficult they find discussions about 'do not attempt cardiopulmonary resuscitation' (DNACPR); (2) whether difficulty is associated with doctors' personal and professional characteristics; (3) how frequently DNACPR discussions are made more difficult by practical issues and by doctors' uncertainties. METHODS: Survey of hospital doctors working on the acute medical wards of a UK NHS teaching hospital. RESULTS: 171/200 (86%) of eligible doctors participated. 165 had experience of DNACPR discussions with older inpatients and/or their families and were included in our analysis. 'Difficulty' (defined as finding discussions 'fairly difficult' or 'difficult') was experienced by 52/165 (32%) for discussions with patients and 60/165 (36%) for discussions with families. Doctors with specific training in DNACPR discussions were less likely to have difficulty in discussions with patients. Older, more experienced doctors were less likely to have difficulty in discussions with families. Lack of time and place, and uncertainty about prognosis were the most frequently reported causes of difficulty. CONCLUSIONS: Many doctors have difficulty in DNACPR discussions. Training needs to include managing discussions with families, as well as with patients, and doctors need time and space to deliver this important part of their job.