Statistical analysis plan for a cluster randomised trial in Madhya Pradesh, India: community health promotion and medical provision and impact on neonates (CHAMPION2).

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.

Proactive and integrated consultation-liaison psychiatry for older medical inpatients: A mixed methods description of training, care provided and clinician experience in the HOME study.

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.

Statistical analysis plan for a cluster randomised trial in Madhya Pradesh, India: support to rural India's public education system and impact on numeracy and literacy scores (STRIPES2).

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.

Depression and anxiety during the year before death from cancer.

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.

The Prevalence of Psychiatric Disorders in General Hospital Inpatients: A Systematic Umbrella Review.

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.

Implementing collaborative care for major depression in a cancer center: An observational study using mixed-methods.

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.

Suicidal Thoughts in Patients With Cancer and Comorbid Major Depression: Findings From a Depression Screening Program.

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.

The prevalence of anxiety in general hospital inpatients: A systematic review and meta-analysis.

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.

'Do not attempt cardiopulmonary resuscitation' (DNACPR)-difficulty in discussions with older medical inpatients and their families: a survey of hospital doctors.

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.

Major Depression and Survival in People With Cancer.

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.

Different independent associations of depression and anxiety with survival in patients with cancer.

OBJECTIVE: Depression and anxiety have both been reported to predict worse subsequent survival in people with cancer. However, depression and anxiety are mutually associated and we lack understanding of their independent associations with survival. We therefore aimed to investigate these in a large sample of patients with common cancers. METHODS: We analysed data on 19,966 patients with common cancers (breast, colorectal, gynaecological, lung and prostate) who had attended specialist NHS outpatient clinics in Scotland, UK. Hospital Anxiety and Depression Scale (HADS) data were linked with demographic, cancer and mortality data. We estimated the independent associations of depression (HADS depression score) and anxiety (HADS anxiety score) with survival by fitting (separately for each cancer) Cox proportional hazards models which incorporated cubic splines to allow for non-linear associations. We also adjusted for potential confounders. RESULTS: The median time from HADS completion to death or censoring was 1.9 years. Greater depression was found to be strongly associated with worse survival from all cancers. When adjusted for anxiety, this association remained in males and increased in females. Greater anxiety was also associated with worse survival in nearly all cancers. However, when adjusted for depression, the association of anxiety with worse survival was lost. In females the association reversed direction so that greater anxiety was associated with better survival. CONCLUSION: Although often considered together as aspects of 'emotional distress', depression and anxiety have different independent associations with survival in patients with cancer and should therefore be considered separately.

The HOME Study: Statistical and economic analysis plan for a randomised controlled trial comparing the addition of Proactive Psychological Medicine to usual care, with usual care alone, on the time spent in hospital by older acute hospital inpatients.

BACKGROUND: Prolonged acute hospital stays are a problem for older people and for health services. Failure to effectively manage the psychological and social aspects of illness is an important cause of prolonged hospital stay. Proactive Psychological Medicine (PPM) is a new way of providing psychiatry services to medical wards which is proactive, focussed, intensive and integrated with medical care. The primary aim of PPM is to reduce the time older people spend in hospital because of unmanaged psychological and social problems. The HOME Study will test the effectiveness and cost-effectiveness of PPM. METHODS/DESIGN: The study is a two-arm, parallel-group, randomised, controlled superiority trial with linked health economic analysis and an embedded process evaluation. The target population is people aged 65 years and older admitted to acute hospitals. Participants will be randomly allocated to either usual care plus PPM or usual care alone. The primary outcome is the number of days spent as an inpatient in a general hospital in the month following randomisation. Secondary outcomes include quality of life, cognitive function, independent functioning, symptoms of anxiety and depression, and experience of hospital stay. The cost-effectiveness of usual care plus PPM compared with usual care alone will be assessed using quality-adjusted life-years as an outcome as well as costs from the NHS perspective. DISCUSSION: This update to the published trial protocol gives a detailed plan of the statistical and economic analysis of The HOME Study. TRIAL REGISTRATION: ISRCTN registry, ISRCTN86120296. Registered on 3 January 2018.

The HOME Study: study protocol for a randomised controlled trial comparing the addition of Proactive Psychological Medicine to usual care, with usual care alone, on the time spent in hospital by older acute hospital inpatients.

BACKGROUND: Prolonged acute hospital stays are a major problem for older people and for health services. Failure to effectively manage the psychological and social aspects of illness is an important cause of prolonged hospital stays. Proactive Psychological Medicine (PPM) is a new way of providing psychiatry services to medical wards. PPM is proactive, focussed, intensive and integrated with medical care. A major aim of PPM is to reduce the time older people spend in hospital because of unmanaged psychological and social problems. The HOME Study will test the effectiveness and cost-effectiveness of PPM. METHODS/DESIGN: A two-arm parallel-group randomised controlled superiority trial, with a linked health economic analysis and an embedded process evaluation, will be conducted at three sites. A total of 3588 participants will be recruited and randomised to usual care or usual care plus PPM. The primary outcome is the number of days spent as an inpatient in a general hospital in the month (30 days) post-randomisation. Secondary outcomes for each participant (measured at 1 and 3 months) include quality of life, independent functioning, symptoms of anxiety and depression, cognitive function, and their experience of the hospital stay. DISCUSSION: The trial has been designed to produce findings that are generalisable to all older medical inpatients (including those with cognitive impairment). It will provide information on the effectiveness and cost-effectiveness of PPM, which we hope will be of value to patients, clinicians, managers and service planners. TRIAL REGISTRATION: ISRCTN86120296 . Registered on 3 January 2018.

C-reactive protein: what to expect after bony hip surgery for nonambulatory children and adolescents with cerebral palsy.

Bony hip reconstruction surgery in children with severe cerebral palsy is associated with high complication rates, usually postoperative chest and urinary tract infections. C-reactive protein (CRP) level is commonly used as an indication of infection; an understanding of its normal postoperative trends is crucial to allow early identification of abnormal levels and possible infection. Our aim was to describe the trends in CRP following bony hip surgery in children who had an uneventful postoperative course, on the basis that the children for whom CRP does not follow this course are likely to have a bacterial infection. A retrospective review was performed of 155 children with CP having bony hip surgery between 2012 and 2016. The median age was 9.9 years (interquartile range: 6.6-12.7). One hundred (64.5%) patients had a Gross Motor Function Classification System rating of V. All CRP levels measured in routine postoperative care were recorded, and medical records were examined for postoperative infective complications. The CRP levels of patients with clinically proven infections were excluded in order to describe what to expect in the absence of infection. Mean CRP peaked on the third postoperative day at 81 mg/l in those who had no postoperative infection. Twenty-five (16.1%) patients had a postoperative infection; their mean CRP was higher on all postoperative days and peaked at 128 mg/l on the third postoperative day. An understanding of the normal postoperative trends in CRP allows identification of those with abnormally raised levels. Postoperative CRP is consistently higher in children with an infective complication. We recommend that the CRP should be routinely checked following bony hip surgery in children with CP, and a careful search for infection undertaken in those with a raised level.

Preoperative botulinum neurotoxin A for children with bilateral cerebral palsy undergoing major hip surgery: a randomized double-blind placebo-controlled trial.

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.

A scoping review of the problems and solutions associated with contamination in trials of complex interventions in mental health.

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.

The association between mentoring and training outcomes in junior doctors in medicine: an observational study.

OBJECTIVE: To determine quantitatively if a positive association exists between the mentoring of junior doctors and better training outcomes in postgraduate medical training within the UK. DESIGN: Observational study. PARTICIPANTS: 117 trainees from the East of England Deanery (non-mentored group) and the recently established Royal College of Physicians (RCP) Mentoring scheme (mentored group) who were core medical trainees (CMTs) between 2015 and 2017 completed an online survey. Trainees who received mentoring at the start of higher specialty training, incomplete responses and trainees who were a part of both the East of England deanery and RCP Mentoring scheme were excluded leaving 85 trainees in the non-mentored arm and 25 trainees in the mentored arm. Responses from a total of 110 trainees were analysed. MAIN OUTCOME MEASURES: Pass rates of the various components of the Membership of the Royal College of Physicians (MRCP) (UK) examination (MRCP Part 1, MRCP Part 2 Written and MRCP Part 2 PACES), pass rates at the Annual Review of Competency Progression (ARCP), trainee involvement in significant events, clinical incidents or complaints and trainee feedback on career progression and confidence. RESULTS: Mentored trainees reported higher pass rates of the MRCP Part 1 exam versus non-mentored trainees (84.0% vs 42.4%, p<0.01). Mentored international medical graduates (IMGs) reported higher pass rates than non-mentored IMGs in the MRCP Part 2 Written exam (71.4% vs 24.0%, p<0.05). ARCP pass rates in mentored trainees were observed to be higher than non-mentored trainees (95.8% vs 69.9%, p<0.05). Rates of involvement in significant events, clinical incidents and complaints in both groups did not show any statistical difference. Mentored trainees reported higher confidence and career progression. CONCLUSIONS: A positive association is observed between the mentoring of CMTs and better training outcomes. Further studies are needed to investigate the causative effects of mentoring in postgraduate medical training within the UK.

Assessing treatment fidelity and contamination in a cluster randomised controlled trial of motivational interviewing and cognitive behavioural therapy skills in type 2 diabetes.

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.

A Systematic Review and Meta-Analysis of the Effectiveness of Acetylcholinesterase Inhibitors and Memantine in Treating the Cognitive Symptoms of Dementia.

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.