Bridging the gap from medical to psychological safety assessment: consensus study in a digital mental health context.

BACKGROUND: Digital Mental Health Interventions (DMHIs) that meet the definition of a medical device are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. The MHRA uses procedures that were originally developed for pharmaceuticals to assess the safety of DMHIs. There is recognition that this may not be ideal, as is evident by an ongoing consultation for reform led by the MHRA and the National Institute for Health and Care Excellence. AIMS: The aim of this study was to generate an experts' consensus on how the medical regulatory method used for assessing safety could best be adapted for DMHIs. METHOD: An online Delphi study containing three rounds was conducted with an international panel of 20 experts with experience/knowledge in the field of UK digital mental health. RESULTS: Sixty-four items were generated, of which 41 achieved consensus (64%). Consensus emerged around ten recommendations, falling into five main themes: Enhancing the quality of adverse events data in DMHIs; Re-defining serious adverse events for DMHIs; Reassessing short-term symptom deterioration in psychological interventions as a therapeutic risk; Maximising the benefit of the Yellow Card Scheme; and Developing a harmonised approach for assessing the safety of psychological interventions in general. CONCLUSION: The implementation of the recommendations provided by this consensus could improve the assessment of safety of DMHIs, making them more effective in detecting and mitigating risk.

Mental health service changes, organisational factors, and patient suicide in England in 1997-2012: a before-and-after study.

BACKGROUND: Research into which aspects of service provision in mental health are most effective in preventing suicide is sparse. We examined the association between service changes, organisational factors, and suicide rates in a national sample. METHODS: We did a before-and-after analysis of service delivery data and an ecological analysis of organisational characteristics, in relation to suicide rates, in providers of mental health care in England. We also investigated whether the effect of service changes varied according to markers of organisational functioning. FINDINGS: Overall, 19 248 individuals who died by suicide within 12 months of contact with mental health services were included (1997-2012). Various service changes related to ward safety, improved community services, staff training, and implementation of policy and guidance were associated with a lower suicide rate after the introduction of these changes (incidence rate ratios ranged from 0·71 to 0·79, p<0·0001). Some wider organisational factors, such as non-medical staff turnover (Spearman's r=0·34, p=0·01) and incident reporting (0·46, 0·0004), were also related to suicide rates but others, such as staff sickness (-0·12, 0·37) and patient satisfaction (-0·06, 0·64), were not. Service changes had more effect in organisations that had low rates of staff turnover but high rates of overall event reporting. INTERPRETATION: Aspects of mental health service provision might have an effect on suicide rates in clinical populations but the wider organisational context in which service changes are made are likely to be important too. System-wide change implemented across the patient care pathway could be a key strategy for improving patient safety in mental health care. FUNDING: The Healthcare Quality Improvement Partnership commissions the Mental Health Clinical Outcome Review Programme, National Confidential Inquiry into Suicide and Homicide by People with Mental Illness, on behalf of NHS England, NHS Wales, the Scottish Government Health and Social Care Directorate, the Northern Ireland Department of Health, Social Services and Public Safety, and the States of Jersey and Guernsey.

A role for risperidone in the treatment of communication disorder and comorbid mental health problems?

This case report describes the co-occurrence of a psychiatric disorder with a specific communication disorder in a teenage girl who presented to youth mental health services in crisis, posing a significant risk of harm to herself and others. Description of this case would be of interest to practitioners in youth mental health in relation to the assessment and treatment of young people with similar difficulties. We present the case of a 17-year-old girl previously admitted to an inpatient adolescent unit. Her diagnosis was reformulated 4 months into her second admission to include a specific communication disorder with both receptive and expressive difficulties, evident from her pragmatic use of language. She was started on risperidone in month eight; following this, a significant improvement was seen and the patient was discharged a month later. Prior to the start of risperidone, a referral had been made to low secure adolescent services for further assessment and advice on management, due to the patient's challenging presentation and poor engagement with treatment.

Does money or the law reduce doctors' working hours in the UK?

What can be learned from a 45-year journey to reduced junior doctors' working hours? The authors investigated the impact of financially punitive measures (the 2001 New Deal contract) and legislation (Working Time Regulations) on the average working week for doctors-in-training.

Learning the lessons from banding appeals: evidence based guidance for running junior doctor rotas.

PURPOSE: Designing and running robust junior doctor rotas is a challenging task and much previous advice has been based on consensus or anecdote. This paper aims to discern the most frequently occurring problems with trainee working patterns and produce evidence-based guidance for implementing and running contract-compliant rotas. DESIGN/METHODOLOGY/APPROACH: A total of 35 secondary care trusts in North West England were invited to supply information on pay banding appeals requested under the New Deal junior doctor contract. Of these, 15 (43 per cent) participated with data from 35 appeals between 2004 and 2012. A thematic analysis was undertaken to discern the commonly occurring causes of contractual breaches. FINDINGS: A total of 83 per cent (n = 29/35) of appeals were based on data showing the rota to be non-compliant with the contract (band 3), with the remainder being compliant with the contract but not in keeping with the pay banding currently assigned. Inability to take adequate natural breaks was the most frequently cited cause of rota non-compliance. Where underlying reasons were given for breaches of hours/rest limits they clustered around 20 themes, the top four being poor or absent dialogue between HR and doctors, excessive workload, inappropriately timed ward rounds, and inadequate or non-existent bleep policies. ORIGINALITY/VALUE: This is the first analysis of banding appeals under the UK junior doctor contract. The findings show that problems with rotas cluster around specific themes. The authors provide recommendations to target these so as to avoid financially detrimental contract breaches and trainee dissatisfaction.

Does access to role models influence future career choice? Impact of psychiatry teaching on recently graduated doctors in the United Kingdom.

OBJECTIVE: The authors determined who provides formal psychiatry teaching to newly-qualified doctors and whether the amount of such teaching correlates to a later career preference for psychiatry. METHODS: Data were collected on the cohort starting work in 2010 until applying to a specialty training program 16 months later. Total hours of psychiatry teaching was compared with the number choosing a residency in the same specialty. RESULTS: A total of 19 hospitals in northwest England provided teaching programs for their interns and first-year residents (U.K. foundation doctors); 15 provided information on doctors' later specialty choice. Only 2.3% of teaching was dedicated to psychiatry. Doctors led a higher proportion of medicine or surgery sessions (63%) than those on psychiatry (48%). Provision of psychiatry teaching was associated with entering psychiatry residency. CONCLUSIONS: Hospitals providing the most formal psychiatry training have the highest proportions matriculating into a psychiatry residency.

Safety during night shifts: a cross-sectional survey of junior doctors' preparation and practice.

OBJECTIVES: We aimed to determine whether junior doctors and trusts in the region make use of published evidence relating to best practice during night shift work that can safeguard alertness, reduce fatigue and limit mistakes. We surveyed junior doctors' preparation for and practice during night shifts, and the working and living conditions offered by hospitals for junior doctors carrying out night duties. DESIGN: Cross-sectional survey. SETTING: An anonymous online questionnaire was sent to junior doctors training within Health Education North West from 13 December 2012 to 14 February 2013. PARTICIPANTS: 32% (16/42) of trusts within Health Education North West sent the survey to 2139 junior doctor email addresses; 24.5% (524/2139) entered data into the survey. RESULTS: 91.6% of surveyed junior doctors worked night shifts. Prior to starting night shifts, 65% do not have a 'prophylactic' afternoon nap. At work, half (49%) can access a room with a reclining chair while 24% have a room with a bed. 37% 'never' achieve a 'natural break' on night shift; 53% 'never' achieve the recommended 20-45 min nap. 91% of respondents were unaware of the duration of sleep inertia that can affect alertness upon waking. When converting between day/night shifts, 2% use light lamps and 6% use non-benzodiazepine sedatives. Principal themes from free text analysis were feeling lethargic or unwell during night shifts, concern for patient and personal safety and inability to rest or take breaks. CONCLUSIONS: The trainees surveyed find night shifts difficult, yet do not/are unable to implement evidence-based recommendations to limit fatigue. Results suggest those surveyed experience a lack of rest facilities within their place of work and a demanding workload. The results may indicate the need to increase awareness of the potential benefits associated with different interventions that can help mitigate the fatigue associated with rotating shift work.