Chris Hinds

Collaboration and Trust in Healthcare Innovation: The eDiaMoND Case Study

This paper presents findings from an investigation into requirements for collaboration in e-Science in the context of eDiaMoND, a Grid-enabled prototype system intended in part to support breast cancer screening. Detailed studies based on ethnographic fieldwork reveal the importance of accountability and visibility of work for trust and for the various forms of ‘practical ethical action’ in which clinicians are seen to routinely engage in this setting. We discuss the implications of our findings, specifically for the prospect of using distributed screening to make more effective use of scarce clinical skills and, more generally, for realising the Grid’s potential for sharing data within and across institutions. Understanding how to afford trust and to provide adequate support for ethical concerns relating to the handling of sensitive data is a particular challenge for e-Health systems and for e-Science in general. Future e-Health and e-Science systems will need to be compatible with the ways in which trust is achieved, and practical ethical actions are realised and embedded within work practices.

The effects of improving sleep on mental health (OASIS): a randomised controlled trial with mediation analysis

Summary Background Sleep difficulties might be a contributory causal factor in the occurrence of mental health problems. If this is true, improving sleep should benefit psychological health. We aimed to determine whether treating insomnia leads to a reduction in paranoia and hallucinations. Methods We did this single-blind, randomised controlled trial (OASIS) at 26 UK universities. University students with insomnia were randomly assigned (1:1) with simple randomisation to receive digital cognitive behavioural therapy (CBT) for insomnia or usual care, and the research team were masked to the treatment. Online assessments took place at weeks 0, 3, 10 (end of therapy), and 22. The primary outcome measures were for insomnia, paranoia, and hallucinatory experiences. We did intention-to-treat analyses. The trial is registered with the ISRCTN registry, number ISRCTN61272251. Findings Between March 5, 2015, and Feb 17, 2016, we randomly assigned 3755 participants to receive digital CBT for insomnia (n=1891) or usual practice (n=1864). Compared with usual practice, the sleep intervention at 10 weeks reduced insomnia (adjusted difference 4·78, 95% CI 4·29 to 5·26, Cohens d=1·11; p<0·0001), paranoia (−2·22, −2·98 to −1·45, Cohens d=0·19; p<0·0001), and hallucinations (−1·58, −1·98 to −1·18, Cohens d=0·24; p<0·0001). Insomnia was a mediator of change in paranoia and hallucinations. No adverse events were reported. Interpretation To our knowledge, this is the largest randomised controlled trial of a psychological intervention for a mental health problem. It provides strong evidence that insomnia is a causal factor in the occurrence of psychotic experiences and other mental health problems. Whether the results generalise beyond a student population requires testing. The treatment of disrupted sleep might require a higher priority in mental health provision. Funding Wellcome Trust.

Comparative evaluation of quetiapine plus lamotrigine combination versus quetiapine monotherapy (and folic acid versus placebo) in bipolar depression (CEQUEL): a 2 × 2 factorial randomised trial

BACKGROUND Depressive symptoms are a major cause of disability in bipolar disorder and there are few safe and effective treatments. The combination of lamotrigine plus quetiapine potentially offers improved outcomes for people with bipolar depression. We aimed to determine if combination therapy with quetiapine plus lamotrigine leads to greater improvement in depressive symptoms over 12 weeks than quetiapine monotherapy plus lamotrigine placebo. METHODS In this double-blind, randomised, placebo-controlled, parallel group, 2 × 2 factorial trial (CEQUEL), patients with DSM-IV bipolar disorder I or II, who were aged 16 years or older, and required new treatment for a depressive episode, were enrolled from 27 sites in the UK. Patients were randomly assigned (1:1) by an adaptive minimisation algorithm to lamotrigine or placebo and to folic acid or placebo. Participants and investigators were masked to the treatment groups. The primary outcome was improvement in depressive symptoms at 12 weeks with the Quick Inventory of Depressive Symptomatology-self report version 16 (QIDS-SR16). Analysis was by modified intention-to-treat. This trial is registered with EUdraCT, number 2007-004513-33. FINDINGS Between Oct 21, 2008, and April 27, 2012, 202 participants were randomly assigned; 101 to lamotrigine and 101 to placebo. The mean difference in QIDS-SR16 total score between the group receiving lamotrigine versus the placebo group at 12 weeks was -1·73 ([95% CI -3·57 to 0·11]; p=0·066) and at 52 weeks was -2·69 ([-4·89 to -0·49]; p=0·017). Folic acid was not superior to placebo. There was a significant interaction (p=0·028), with folic acid reducing the effectiveness of lamotrigine at 12 weeks. The mean difference on QIDS-SR16 was -4·14 ([95% CI -6·90 to -1·37]; p=0·004) for patients receiving lamotrigine without folic acid compared with 0·12 ([-2·58 to 2·82]; p=0·931) for those receiving lamotrigine and folic acid. INTERPRETATION Addition of lamotrigine to quetiapine treatment improved outcomes. Folic acid seems to nullify the effect of lamotrigine. CEQUEL should encourage clinicians and patients to consider lamotrigine for bipolar depression, but also to be aware that concurrent folic acid might reduce its effectiveness. FUNDING Medical Research Council.

The case against a positivist philosophy of requirements engineering

Requirements engineering is a field with a heavy practical emphasis and for the most part is quite rightly unconcerned with philosophical reflection. However, there have been exceptions. Philosophical arguments are important because they can be used to powerful effect, facilitating explicit debate on views that may previously have been implicit, and shaping the direction of thought and research within the field. Several cases from both requirements engineering and software engineering have given prominence to the philosophy of positivism. This paper will outline arguments against such a view.

Longitudinal mood monitoring in bipolar disorder: Course of illness as revealed through a short messaging service

BACKGROUND Online self-monitoring of mood can be used to investigate differences in course patterns across patient groups. This study explored the feasibility of remote symptom capture with True Colours, a self-rated online mood monitoring tool completed on a weekly basis. METHODS Participants with bipolar disorder (N = 297) completed weekly depression and mania questionnaires over an average of 27.5 months (range 1 -81 months). Subgroups defined by sex, age, and bipolar I vs. II status were compared on time in various mood states, number of episodes, and week-to-week mood variability. RESULTS Compliance with weekly questionnaires was generally high (median, 92% of weeks). Mood symptoms occurred for an average of 55.4% of weeks across the follow-up period. Females spent more time with hypomanic/manic and depressive symptoms and had more depressive episodes compared to males. Younger participants were found to experience more hypomanic/manic episodes and showed greater variability in mood symptoms than older participants. No significant differences in mood symptoms or variability were observed between bipolar I and II patients. LIMITATIONS This was a naturalistic study with a heterogeneous cohort, and did not include a control group. True Colours does not identify mood fluctuations that may occur in the days between weekly assessments. CONCLUSIONS Monitoring moods through an online tool is both feasible and informative regarding course of illness in patients with bipolar disorder. Interventions aiming to reduce mood variability and manic/hypomanic episodes in the early phases of bipolar disorder may enhance the long-term symptomatic course of the illness.

On the importance of intellectual property rights for e-science and the integrated health record.

An integrated health record (IHR) that enables clinical data to be shared at a national level has profound implications for medical research. Data that have been useful primarily within a single clinic will instead be free to move rapidly around a national network infrastructure. This raises challenges for technologists, clinical practice, and for the governance of these data. This article considers one specific issue that is currently poorly understood: how intellectual property (IP) relates to the sharing of medical data for research on large-scale electronic networks. Based on an understanding of current practices, this article presents recommendations for the governance of IP in an integrated health record.

Web-Based Violence Risk Monitoring Tool in Psychoses: Pilot Study in Community Forensic Patients.

ABSTRACT We describe the development and pilot testing of a novel, web-based, violence risk monitoring instrument for use in community patients with psychoses. We describe the development of the tool, including drawing on systematic reviews of the field, how item content was operationalized, the development of a user interface, and its subsequent piloting. Sixty-eight patients were included from three English counties, who had been discharged from forensic psychiatric services. Over 12 months, 310 questionnaires were completed on the sample by professionals from several disciplines and qualitative feedback collected relating to the use of the tool using an electronic survey. Strengths of this approach for risk assessment, and potential limitations and areas for future research, are discussed.

1003 - New Faecal Calprotectin Cut-Off Points for Remission and Active Disease Defined by Uceis and Nancy Indices in Ulcerative Colitis

Disease activity assessment is an essential part of clinical management in UC, most accurately evaluated by endoscopy and biopsy, since patient symptoms may not reliably reflect activity. Published cut-offs for faecal calprotectin (FCal) in UC are largely based on prediction of relapse, rather than prediction of endoscopic or histopathologic activity.

Digital technologies for the assessment of cognition: a clinical review

Dementia is the most widespread form of neurodegenerative disorder and is associated with an immense societal and personal cost. Prevalence of this disorder is projected to triple worldwide by 2050 leading to an urgent need to make advances in the efficiency of both its care and therapy research. Digital technologies are a rapidly advancing field that provide a previously unavailable opportunity to alleviate challenges faced by clinicians and researchers working in this area. This clinical review aimed to summarise currently available evidence on digital technologies that can be used to monitor cognition. We identified a range of pervasive digital systems, such as smartphones, smartwatches and smart homes, to assess and assist elderly demented, prodromal and preclinical populations. Generally, the studies reported good level of agreement between the digital measures and the constructs they aimed to measure. However, most of the systems are still only in the initial stages of development with limited data on acceptability in patients. Although it is clear that the use of digital technology to monitor and support the cognitive domains affected by dementia is a promising area of development, additional research validating the efficacy, utility and cost-effectiveness of these systems in patient populations is needed.

Biochemical and genetic predictors and correlates of response to lamotrigine and folic acid in bipolar depression: Analysis of the CEQUEL clinical trial

CEQUEL (Comparative Evaluation of QUEtiapine plus Lamotrigine combination versus quetiapine monotherapy [and folic acid versus placebo] in bipolar depression) was a double‐blind, randomized, placebo‐controlled, parallel group, 2×2 factorial trial that examined the effect of adding lamotrigine and/or folic acid (FA) to quetiapine in bipolar depression. Lamotrigine improved depression, but its effectiveness was reduced by FA. We investigated the baseline predictors and correlates of clinical response, and the possible basis of the interaction.