Fifteen-minute consultation: An evidence-based approach to research without prior consent (deferred consent) in neonatal and paediatric critical care trials

What do we mean by research without prior consent (deferred consent)? Emergency research with critically unwell children is vital to make sure that the most ill and injured children benefit from evidence-based healthcare.1 Ethical guidance require that consent be sought from parents (or legal representatives) on behalf of their children2 before research is initiated, yet concerns about problems in seeking parents’ consent when their child is critically ill have been a significant barrier to conducting clinical trials.3 ,4 Taking time out to seek informed consent before starting treatment will often be difficult to justify as delaying any intervention in an emergency could diminish a child's chances of recovery. Parents will usually be highly distressed in a critical care situation, and many will struggle to make an informed decision about research in the limited time available. Many countries have legislated to permit variations to informed consent and allow progress in research to develop critical care treatments.5–7 While the details vary, a common feature is that informed consent is not requested before the patient receives the intervention being researched.8 In the USA, the Food and Drug Administration (FDA) Exception from Informed Consent (EFIC) essentially ‘waives’ informed consent, although practitioners must show that they have attempted to contact legal representatives and tried to provide the opportunity to ‘opt out’ of a trial.5 ,9 The FDA's detailed guidance aims to assist researchers in implementing EFIC,10 ,11 although the accompanying public consultation requirements have led to varied practice and costly delays in setting up trialsCATCH was funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) programme (project number 08/13/47). CONNECTwas funded by Wellcome Trust (WT095874MF) and supported by the MRC Network of Hubs for Trials Methodology Research (MR/L004933/1- R/N42)

Alcohol dependence in public policy: towards its (re)inclusion

Public policy on alcohol in the UK relies on health promotion campaigns that encourage individuals who misuse alcohol to make healthier choices about their drinking. Individuals with alcohol-dependence syndrome have an impaired capacity to choose health. As a result, individuals with the worst alcohol misuse problems lie largely outside the reach of choice-based policy. However, such policy has been widely criticized and efforts to reform it are underway. This paper argues that the British Medical Association’s recent attempt to improve policy on alcohol in the UK by introducing strategies which have been shown to control drinking within populations still gives insufficient attention to alcohol dependence. This is because it fails accurately and consistently to characterize alcohol dependence and gives insufficient attention to the social challenges it presents

Predictive risk stratification model: a randomised stepped-wedge trial in primary care (PRISMATIC)

Background: With a higher proportion of older people in the UK population, new approaches are needed to reduce emergency hospital admissions, thereby shifting care delivery out of hospital when possible and safe. Study aim: To evaluate the introduction of predictive risk stratification in primary care. Objectives: To (1) measure the effects on service usage, particularly emergency admissions to hospital; (2) assess the effects of the Predictive RIsk Stratification Model (PRISM) on quality of life and satisfaction; (3) assess the technical performance of PRISM; (4) estimate the costs of PRISM implementation and its effects; and (5) describe the processes of change associated with PRISM. Design: Randomised stepped-wedge trial with economic and qualitative components. Setting: Abertawe Bro Morgannwg University Health Board, south Wales. Participants: Patients registered with 32 participating general practices. Intervention: PRISM software, which stratifies patients into four (emergency admission) risk groups; practice-based training; and clinical support. Main outcome measures: Primary outcome – emergency hospital admissions. Secondary outcomes – emergency department (ED) and outpatient attendances, general practitioner (GP) activity, time in hospital, quality of life, satisfaction and costs. Data sources: Routine anonymised linked health service use data, self-completed questionnaires and staff focus groups and interviews. Results: Across 230,099 participants, PRISM implementation led to increased emergency admissions to hospital [ΔL = 0.011, 95% confidence interval (CI) 0.010 to 0.013], ED attendances (ΔL = 0.030, 95% CI 0.028 to 0.032), GP event-days (ΔL = 0.011, 95% CI 0.007 to 0.014), outpatient visits (ΔL = 0.055, 95% CI 0.051 to 0.058) and time spent in hospital (ΔL = 0.029, 95% CI 0.026 to 0.031). Quality-of-life scores related to mental health were similar between phases (Δ = –0.720, 95% CI –1.469 to 0.030); physical health scores improved in the intervention phase (Δ = 1.465, 95% CI 0.774 to 2.157); and satisfaction levels were lower (Δ = –0.074, 95% CI – 0.133 to –0.015). PRISM implementation cost £0.12 per patient per year and costs of health-care use per patient were higher in the intervention phase (Δ = £76, 95% CI £46 to £106). There was no evidence of any significant difference in deaths between phases (9.58 per 1000 patients per year in the control phase and 9.25 per 1000 patients per year in the intervention phase). PRISM showed good general technical performance, comparable with existing risk prediction tools (c-statistic of 0.749). Qualitative data showed low use by GPs and practice staff, although they all reported using PRISM to generate lists of patients to target for prioritised care to meet Quality and Outcomes Framework (QOF) targets. Limitations: In Wales during the study period, QOF targets were introduced into general practice to encourage targeting care to those at highest risk of emergency admission to hospital. Within this dynamic context, we therefore evaluated the combined effects of PRISM and this contemporaneous policy initiative. Conclusions: Introduction of PRISM increased emergency episodes, hospitalisation and costs across, and within, risk levels without clear evidence of benefits to patients. Future research: (1) Evaluation of targeting of different services to different levels of risk; (2) investigation of effects on vulnerable populations and health inequalities; (3) secondary analysis of the Predictive Risk Stratification: A Trial in Chronic Conditions Management data set by health condition type; and (4) acceptability of predictive risk stratification to patients and practitioners. Trial and study registration: Current Controlled Trials ISRCTN55538212 and PROSPERO CRD42015016874. Funding: The National Institute for Health Research Health Services Delivery and Research programme

Care and communication between health professionals and patients affected by severe or chronic illness in community care settings: a qualitative study of care at the end of life

Background: Advance care planning (ACP) enables patients to consider, discuss and, if they wish, document their wishes and preferences for future care, including decisions to refuse treatment, in the event that they lose capacity to make decisions for themselves. ACP is a key component of UK health policy to improve the experience of death and dying for patients and their families. There is limited evidence about how patients and health professionals understand ACP, or when and how this is initiated. It is evident that many people find discussion of and planning for end of life care difficult, and tend to avoid the topic. Aim: To investigate how patients, their relatives and health professionals initiate and experience discussion of ACP and the outcomes of advance discussions in shaping care at the end of life. Design and data collection: Qualitative study with two workstreams: (1) interviews with 37 health professionals (general practitioners, specialist nurses and community nurses) about their experiences of ACP; and (2) longitudinal case studies of 21 patients with 6-month follow-up. Cases included a patient and, where possible, a nominated key relative and/or health professional as well as a review of medical records. Complete case triads were obtained for 11 patients. Four cases comprised the patient alone, where respondents were unable or unwilling to nominate either a family member or a professional carer they wished to include in the study. Patients were identified as likely to be within the last 6 months of life. Ninety-seven interviews were completed in total. Setting: General practices and community care settings in the East Midlands of England. Findings: The study found ACP to be uncommon and focused primarily on specific documented tasks involving decisions about preferred place of death and cardiopulmonary resuscitation, supporting earlier research. There was no evidence of ACP in nearly half (9 of 21) of patient cases. Professionals reported ACP discussions to be challenging. It was difficult to recognise when patients had entered the last year of life, or to identify their readiness to consider future planning. Patients often did not wish to do so before they had become gravely ill. Consequently, ACP discussions tended to be reactive, rather than pre-emptive, occurring in response to critical events or evidence of marked deterioration. ACP discussions intersected two parallel strands of planning: professional organisation and co-ordination of care; and the practical and emotional preparatory work that patients and families undertook to prepare themselves for death. Reference to ACP as a means of guiding decisions for patients who had lost capacity was rare. Conclusions: Advance care planning remains uncommon, is often limited to documentation of a few key decisions, is reported to be challenging by many health professionals, is not welcomed by a substantial number of patients and tends to be postponed until death is clearly imminent. Current implementation largely ignores the purpose of ACP as a means of extending personal autonomy in the event of lost capacity. Future work: Attention should be paid to public attitudes to death and dying (including those of culturally diverse and ethnic minority groups), place of death, resuscitation and the value of anticipatory planning. In addition the experiences and needs of two under-researched groups should be explored: the frail elderly, including those who manage complex comorbid conditions, unrecognised as vulnerable cases; and those patients affected by stigmatised conditions, such as substance abuse or serious mental illness who fail to engage constructively with services and are not recognised as suitable referrals for palliative and end of life care. Funding: The National Institute for Health Research Health Services and Delivery Research programme

What is the impact of rerouting a cancer diagnosis from emergency presentation to GP referral on resource use and survival? Evidence from a population-based study

Background: Studies on alternative routes to diagnosis stimulated successful policy interventions reducing the number of emergency diagnoses and associated mortality risk. A dearth of evidence on the costs of such interventions might prevent new policies from achieving more ambitious targets. Methods: We conducted a retrospective cohort study on the population of colorectal (88,051), breast (90,387), prostate (96,219), and lung (97,696) cancer patients diagnosed after a GP referral or an emergency presentation and reported in the Cancer Registry of England. Resource use and survival were compared 1 year before and 5 years after diagnosis (3 years for lung), including the costs of GP referrals not converted into a positive diagnosis. Risk-adjusted statistical models were used to calculate the effect of rerouting patient' diagnoses from emergency presentation to GP referral. Results: Rerouting a cancer diagnosis results in a relatively small additional costs to the National Health System against additional years of life saved to the patient. The cost per year of life saved is £6456 in colorectal, £1057 in breast, £662 in prostate (savings), and £819 in lung cancer. Reducing the overall prevalence of emergency presentations to the level achieved by the 20% of Clinical Commissioning Groups with the lowest prevalence would result in £11,481,948 against 1863 years of life saved for Colorectal, £847,750 against 889 years for breast, £943,434 (cost savings) against 1195 years for prostate, and £609,938 against 1011 years for lung cancer. Conclusion: Redirecting diagnoses from emergency presentation to GP referral appears an achievable target that can produce large benefits to patients against modest additional costs to the National Health System

The behaviour change wheel: a new method for characterising and designing behaviour change interventions

Background: Improving the design and implementation of evidence-based practice depends on successful behaviour change interventions. This requires an appropriate method for characterising interventions and linking them to an analysis of the targeted behaviour. There exists a plethora of frameworks of behaviour change interventions, but it is not clear how well they serve this purpose. This paper evaluates these frameworks, and develops and evaluates a new framework aimed at overcoming their limitations.Methods: A systematic search of electronic databases and consultation with behaviour change experts were used to identify frameworks of behaviour change interventions. These were evaluated according to three criteria: comprehensiveness, coherence, and a clear link to an overarching model of behaviour. A new framework was developed to meet these criteria. The reliability with which it could be applied was examined in two domains of behaviour change: tobacco control and obesity.Results: Nineteen frameworks were identified covering nine intervention functions and seven policy categories that could enable those interventions. None of the frameworks reviewed covered the full range of intervention functions or policies, and only a minority met the criteria of coherence or linkage to a model of behaviour. At the centre of a proposed new framework is a 'behaviour system' involving three essential conditions: capability, opportunity, and motivation (what we term the 'COM-B system'). This forms the hub of a 'behaviour change wheel' (BCW) around which are positioned the nine intervention functions aimed at addressing deficits in one or more of these conditions; around this are placed seven categories of policy that could enable those interventions to occur. The BCW was used reliably to characterise interventions within the English Department of Health's 2010 tobacco control strategy and the National Institute of Health and Clinical Excellence's guidance on reducing obesity.Conclusions: Interventions and policies to change behaviour can be usefully characterised by means of a BCW comprising: a 'behaviour system' at the hub, encircled by intervention functions and then by policy categories. Research is needed to establish how far the BCW can lead to more efficient design of effective interventions

Cognitive behaviour therapy (CBT) for anxiety and depression in adults with mild intellectual disabilities (ID): a pilot randomised controlled trial

Background: Several studies have showed that people with intellectual disabilities (ID) have suitable skills to undergo cognitive behavioural therapy (CBT). Case studies have reported successful use of cognitive behavioural therapy techniques (with adaptations) in people with ID. Modified cognitive behavioural therapy may be a feasible and effective approach for the treatment of depression, anxiety, and other mood disorders in ID. To date, two studies have reported group-based manaulised cognitive behavioural treatment programs for depression in people with mild ID. However, there is no individual manualised programme for anxiety or depression in people with intellectual disabilities. The aims of the study are to determine the feasibility of conducting a randomised controlled trial for CBT in people with ID. The data will inform the power calculation and other aspects of carrying out a definitive randomised controlled trial.Methods: Thirty participants with mild ID will be allocated randomly to either CBT or treatment as usual (TAU). The CBT group will receive up to 20 hourly individual CBT over a period of 4 months. TAU is the standard treatment which is available to any adult with an intellectual disability who is referred to the intellectual disability service (including care management, community support, medical, nursing or social support). Beck Youth Inventories (Beck Anxiety Inventory & Beck Depression Inventory) will be administered at baseline; end of treatment (4 months) and at six months to evaluate the changes in depression and anxiety. Client satisfaction, quality of life and the health economics will be secondary outcomes.Discussion: The broad outcome of the study will be to produce clear guidance for therapists to apply an established psychological intervention and identify how and whether it works with people with intellectual disabilities