Publications by authors named "Laura Potts"

23 Publications

  • Page 1 of 1

ADVANCE integrated group intervention to address both substance use and intimate partner abuse perpetration by men in substance use treatment: a feasibility randomised controlled trial.

BMC Public Health 2021 05 25;21(1):980. Epub 2021 May 25.

Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.

Background: Substance use is a risk factor for intimate partner abuse (IPA) perpetration. Delivering perpetrator interventions concurrently with substance use treatment shows promise.

Methods: The feasibility of conducting an efficacy and cost-effectiveness trial of the ADVANCE 16-week intervention to reduce IPA by men in substance use treatment was explored. A multicentre, parallel group individually randomised controlled feasibility trial and formative evaluation was conducted. Over three temporal cycles, 104 men who had perpetrated IPA towards a female (ex) partner in the past year were randomly allocated to receive the ADVANCE intervention + substance use treatment as usual (TAU) (n = 54) or TAU only (n = 50) and assessed 16-weeks post-randomisation. Participants' (ex) partners were offered support and 27 provided outcome data. Thirty-one staff and 12 men who attended the intervention participated in focus groups or interviews that were analysed using the framework approach. Pre-specified criteria assessed the feasibility of progression to a definitive trial: 1) ≥ 60% of eligible male participants recruited; 2) intervention acceptable to staff and male participants; 3) ≥ 70% of participants followed-up and 4) levels of substance use and 5) IPA perpetrated by men in the intervention arm did not increase from average baseline level at 16-weeks post-randomisation.

Results: 70.7% (104/147) of eligible men were recruited. The formative evaluation confirmed the intervention's acceptability. Therapeutic alliance and session satisfaction were rated highly. The overall median rate of intervention session attendance (of 14 compulsory sessions) was 28.6% (range 14.3-64.3% by the third cycle). 49.0% (51/104) of men and 63.0% (17/27) of their (ex) partners were followed-up 16-weeks post-randomisation. This increased to 100% of men and women by cycle three. At follow-up, neither substance use nor IPA perpetration had worsened for men in the intervention arm.

Conclusions: It was feasible to deliver the ADVANCE intervention in substance use treatment services, although it proved difficult to collect data from female (ex)partners. While some progression criteria were met, others were not, although improvements were demonstrated by the third cycle. Lessons learned will be implemented into the study design for a definitive trial of the ADVANCE intervention.

Trial Registration: ISRCTN79435190 prospectively registered 22nd May 2018.
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http://dx.doi.org/10.1186/s12889-021-11012-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8147906PMC
May 2021

Evaluation of anti-stigma social marketing campaigns in Ghana and Kenya: Time to Change Global.

BMC Public Health 2021 05 8;21(1):886. Epub 2021 May 8.

Health Service and Population Research Department, King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, SE5 8AF, UK.

Background: Launched in 2018, Time to Change Global is a new anti-stigma programme to tackle stigma and discrimination towards people with mental health problems in low- and middle-income countries. Our aim was to evaluate pre-post changes in stigma within the target populations for the social marketing campaigns ran in Ghana and Kenya carried out as components of the wider Time to Change Global programme.

Methods: Using data collected before and after each campaign in Accra and Nairobi, we investigated pre-post differences in stigma-related outcome measures: mental health-related knowledge (MAKS), mental health-related attitudes (CAMI), and desire for social distance (RIBS), with regression analyses. Other covariates were included in the models to control for differences in participant demographics.

Results: A significant positive change in a stigma related outcome was found at each site. Reported in standard deviation units, desire for social distance from people with mental health problems in Accra was lower after the launch of the campaign, measured as an increase in intended contact (β = 0.29, 95% CI = 0.14 to 0.43, p < 0.001). In Nairobi, the stigma related knowledge score was higher in the post campaign sample (β = 0.21, 95% CI = 0.07 to 0.34, p = 0.003).

Conclusion: The increase in intended contact in the absence of other changes seen in Ghana, is consistent with the early results for Time to Change England. The estimate for the magnitude of this change is the same as Time to Change England for the general population between 2009 and 19, a very promising result for a short term public mental health campaign. The different results observed between sites may be due to campaign as well as population differences.
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http://dx.doi.org/10.1186/s12889-021-10966-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8106856PMC
May 2021

Optimising psychological treatment for Anxiety DisordErs in Pregnancy (ADEPT): study protocol for a feasibility trial of time-intensive CBT versus weekly CBT.

Pilot Feasibility Stud 2021 Apr 30;7(1):101. Epub 2021 Apr 30.

Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.

Background: Moderate to severe anxiety disorders such as obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), social phobia and panic disorder are common, and affect approximately 11-16% of women in pregnancy. Psychological treatments for anxiety disorders, primarily cognitive behaviour therapy (CBT), have a substantial evidence base and recently time-intensive versions have been found as effective as weekly treatments. However, this has not been trialled in women who are pregnant, where a shorter intervention may be desirable.

Methods: The ADEPT study is a feasibility randomised controlled trial with two parallel intervention groups. Time-intensive one-to-one CBT and standard weekly one-to-one CBT delivered during pregnancy will be compared. Feasibility outcomes including participation and follow-up rates will be assessed, alongside the acceptability of the interventions using qualitative methods.

Discussion: The study will provide preliminary data to inform the design of a full-scale randomised controlled trial of a time-intensive intervention for anxiety during pregnancy. This will include information on the acceptability of time-intensive interventions for pregnant women with anxiety disorders.

Trial Registration: https://doi.org/10.1186/ISRCTN81203286 prospectively registered 27/6/2019.
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http://dx.doi.org/10.1186/s40814-021-00838-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8085465PMC
April 2021

Characteristics and mortality rates among patients requiring intermediate care: a national cohort study using linked databases.

BMC Med 2021 02 12;19(1):48. Epub 2021 Feb 12.

King's College London, Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, Bessemer Road, London, SE5 9PJ, England.

Background: Adults increasingly live and die with chronic progressive conditions into advanced age. Many live with multimorbidity and an uncertain illness trajectory with points of marked decline, loss of function and increased risk of end of life. Intermediate care units support mainly older adults in transition between hospital and home to regain function and anticipate and plan for end of life. This study examined the patient characteristics and the factors associated with mortality over 1 year post-admission to an intermediate care unit to inform priorities for care.

Methods: A national cohort study of adults admitted to intermediate care units in England using linked individual-level Hospital Episode Statistics and death registration data. The main outcome was mortality within 1 year from admission. The cohort was examined as two groups with significant differences in mortality between main diagnosis of a non-cancer condition and cancer. Data analysis used Kaplan-Meier curves to explore mortality differences between the groups and a time-dependant Cox proportional hazards model to determine mortality risk factors.

Results: The cohort comprised 76,704 adults with median age 81 years (IQR 70-88) admitted to 220 intermediate care units over 1 year in 2016. Overall, 28.0% died within 1 year post-admission. Mortality varied by the main diagnosis of cancer (total n = 3680, 70.8% died) and non-cancer condition (total n = 73,024, 25.8% died). Illness-related factors had the highest adjusted hazard ratios [aHRs]. At 0-28 days post-admission, risks were highest for non-cancer respiratory conditions (pneumonia (aHR 6.17 [95%CI 4.90-7.76]), chronic obstructive pulmonary disease (aHR 5.01 [95% CI 3.78-6.62]), dementia (aHR 5.07 [95% CI 3.80-6.77]) and liver disease (aHR 9.75 [95% CI 6.50-14.6]) compared with musculoskeletal disorders. In cancer, lung cancer showed largest risk (aHR 1.20 [95%CI 1.04-1.39]) compared with cancer 'other'. Risks increased with high multimorbidity for non-cancer (aHR 2.57 [95% CI 2.36-2.79]) and cancer (aHR 2.59 [95% CI 2.13-3.15]) (reference: lowest).

Conclusions: One in four patients died within 1 year. Indicators for palliative care assessment are respiratory conditions, dementia, liver disease, cancer and rising multimorbidity. The traditional emphasis on rehabilitation and recovery in intermediate care units has changed with an ageing population and the need for greater integration of palliative care.
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http://dx.doi.org/10.1186/s12916-021-01912-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7880511PMC
February 2021

Health impact assessment to predict the impact of tobacco price increases on COPD burden in Italy, England and Sweden.

Sci Rep 2021 Jan 27;11(1):2311. Epub 2021 Jan 27.

National Heart and Lung Institute, Emmanuel Kaye Building, Imperial College London, 1B Manresa Road, London, SW3 6LR, UK.

Raising tobacco prices effectively reduces smoking, the main risk factor for chronic obstructive pulmonary disease (COPD). Using the Health Impact Assessment tool "DYNAMO-HIA", this study quantified the reduction in COPD burden that would occur in Italy, England and Sweden over 40 years if tobacco prices were increased by 5%, 10% and 20% over current local prices, with larger increases considered in secondary analyses. A dynamic Markov-based multi-state simulation modelling approach estimated the effect of changes in smoking prevalence states and probabilities of transitioning between smoking states on future smoking prevalence, COPD burden and life expectancy in each country. Data inputs included demographics, smoking prevalences and behaviour and COPD burden from national data resources, large observational cohorts and datasets within DYNAMO-HIA. In the 20% price increase scenario, the cumulative number of COPD incident cases saved over 40 years was 479,059 and 479,302 in Italy and England (populous countries with higher smoking prevalences) and 83,694 in Sweden (smaller country with lower smoking prevalence). Gains in overall life expectancy ranged from 0.25 to 0.45 years for a 20 year-old. Increasing tobacco prices would reduce COPD burden and increase life expectancy through smoking behavior changes, with modest but important public health benefits observed in all three countries.
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http://dx.doi.org/10.1038/s41598-021-81876-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7840977PMC
January 2021

Relationships between types of UK national newspapers, illness classification, and stigmatising coverage of mental disorders.

Soc Psychiatry Psychiatr Epidemiol 2021 Jan 22. Epub 2021 Jan 22.

Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.

Background: Media coverage on mental health problems has been found to vary by newspaper type, and stigma disproportionately affects people with mental illness by diagnosis.

Objective: This study investigated the relationships between types of UK national newspaper (tabloid vs. broadsheet), illness classification (SMI-severe mental illnesses vs. CMD-common mental disorders), and stigmatising coverage of mental disorders, and whether these relationships changed over the course of the Time to Change anti-stigma programmes in England and Wales.

Methods: Secondary analysis of data from a study of UK newspaper coverage of mental illness was performed. Relevant articles from nine UK national newspapers in 2008-11, 2013, 2016 and 2019 were retrieved. A structured coding framework was used for content analysis. The odds an article was stigmatising in a tabloid compared to a broadsheet, and about SMI compared to CMD, were calculated. Coverage of CMD and SMI by newspaper type was compared using the content elements categorised as stigmatising or anti-stigmatising.

Results: 2719 articles were included for analysis. Articles in tabloids had 1.32 times higher odds of being stigmatising than articles in broadsheet newspapers (OR 1.32, 95% CI 1.12-1.55). Odds of stigmatising coverage was 1.72 times higher for articles on SMI than CMD (OR  1.72, 95% CI 1.39-2.13). Different patterns in reporting were observed when results were stratified by years for all analyses. A few significant associations were observed for the portrays of stigmatising elements between tabloid and broadsheet newspapers regarding SMI or CMD.

Conclusions: Tailored interventions are needed for editors and journalists of different newspaper types, to include specific strategies for different diagnoses.
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http://dx.doi.org/10.1007/s00127-021-02027-7DOI Listing
January 2021

The Rapid Risk of Violence Screen (RROVS): a Brief Violence Risk Screening Tool for People in a Community Behavioral Health Setting.

J Behav Health Serv Res 2020 Nov 5. Epub 2020 Nov 5.

Ohio Department of Mental Health and Addiction Services, Columbus, OH, USA.

The Rapid Risk of Violence Screen (RROVS) is a brief screening tool that is designed for use in community-based behavioral health service settings to identify people who may need comprehensive violence risk assessment. This study examined the association between the RROVS total score and future criminal justice involvement including violent offenses. Results from this study suggest that the RROVS screening tool has predictive validity as it is associated with later criminal justice involvement with a violent offense. The RROVS may be a helpful tool for community-based behavioral health providers to screen incoming clients for violence risk to inform whether additional assessment for violence potential is warranted.
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http://dx.doi.org/10.1007/s11414-020-09736-yDOI Listing
November 2020

Mothers' experiences of acute perinatal mental health services in England and Wales: a qualitative analysis.

J Reprod Infant Psychol 2020 Sep 3:1-13. Epub 2020 Sep 3.

Section of Women's Mental Health, King's College London, London, UK.

Background/objective: Perinatal mental health services are a current NHS priority and services are being increased for women. There is limited research on mothers' perspectives of these services and most research focuses on mother and baby units (MBUs). This study explored women's views of their experiences of generic wards, MBUs and crisis resolution teams.

Methods: A qualitative thematic analysis was conducted on written feedback on a service-user-designed questionnaire. One hundred and thirty-nine women recruited across 42 mental health trusts made comments.

Results: Two key themes were identified: support networks and staff authority. Support networks included subthemes relating to families, peers and staff. The theme of staff authority incorporated subthemes about communication, confidence in staff and service-user autonomy. All themes contributed to whether mothers felt safe in these services. Mothers reported the benefits of positive, non-coercive relationships with family and staff for their recovery. The findings highlight that the challenges women face in perinatal settings reflect the literature on general psychiatric services, particularly around coercion.

Conclusions: Specific implications for mothers accessing perinatal mental health services: 1) integrated mental health care and support with babies; 2) support with separation from babies for mothers in acute wards; 3) improvement of women's relationships with social services across all services.
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http://dx.doi.org/10.1080/02646838.2020.1814225DOI Listing
September 2020

Moderation by socioeconomic status of the relationship between familiarity with mental illness and stigma outcomes.

SSM Popul Health 2020 Aug 12;11:100611. Epub 2020 Jun 12.

Health Service and Population Research Department, King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, SE5 8AF, UK.

Purpose: Multiple studies suggest response to mental health treatment is worse for people of lower socioeconomic status, a group who also express more mental illness stigma. Worse response to treatment may lead to greater therapeutic pessimism, an important component of stigma. However, familiarity with mental illness is associated with lower levels of stigma. This study therefore examines whether, among the general public, socioeconomic status moderates the relationships between familiarity and stigma related outcomes: knowledge; attitudes; and desire for social distance.

Methods: We carried out secondary analysis of data from the Attitudes to Mental Illness survey, collected annually from different general population samples from 2009-17, and every two years from 2017-19. Three separate multiple linear regression models examined factors associated with each outcome, with interaction tests between socioeconomic status and familiarity. Stigma related knowledge was measured using the Mental Health Knowledge Schedule (MAKS), which includes items on treatment effectiveness and recovery, thus addressing aspects of therapeutic pessimism. Attitudes were measured using the Community Attitudes towards the Mentally Ill Scale; and desire for social distance using the Reported and Intended Behaviour scale.

Results: In lower socioeconomic groups, personal experience was more frequent, while familiarity with someone else was less frequent. Interaction tests were significant for stigma related knowledge (p<0.0001) and desire for social distance (p=0.0118), but not for attitudes (p=0.057). The direction of the interaction differed between knowledge and the other outcomes. In lower socioeconomic groups the positive effect of familiarity on knowledge was weaker, as hypothesised, but for attitudes and desire for social distance, its effect was stronger.

Conclusions: Our results support the promotion of familiarity through encouraging discussion of mental health problems within social networks. However, lower stigma related knowledge among people with personal experience in lower socioeconomic groups suggests different responses to mental illness among these groups are needed.
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http://dx.doi.org/10.1016/j.ssmph.2020.100611DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7378684PMC
August 2020

Mental illness stigma after a decade of Time to Change England: inequalities as targets for further improvement.

Eur J Public Health 2020 06;30(3):526-532

Faculty of Life Sciences and Medicine, School of Population Health and Environmental Sciences, King's College London, London, SE5 8AF, UK.

Background: England's Time to Change programme to reduce mental health-related stigma and discrimination included a social marketing campaign using traditional and social media, and targeted middle-income groups aged 25-45 between 2009 and 2016. From 2017, the same age group on low to middle incomes were targeted, and the content focused on men's mental health, by changing the advertising and adapting the 'key messages'. This study investigates changes in stigma-related public knowledge, attitudes and desire for social distance in England since Time to Change began in 2008-19 and for 2017-19.

Methods: Using data from a face-to-face survey of a nationally representative quota sample of adults for England, we evaluated longitudinal trends in outcomes with regression analyses and made assumptions based on a simple random sample. The pre-existing survey used a measure of attitudes; measures of knowledge and desire for social distance were added in 2009.

Results: Reported in standard deviation units (95% CI), the improvement for knowledge for 2009-19 was 0.25 (0.19, 0.32); for attitudes, 2008-19, 0.32 (0.26, 0.39) and for desire for social distance, 2009-19 0.29 (0.23, 0.36). Significant interactions between year and both region and age suggest greater improvements in London, where stigma is higher, and narrowing of age differences. There were significant improvements between 2017 and 2019 in knowledge [0.09 (0.02, 0.16)] and attitudes [0.08 (0.02, 0.14)] but not social distance.

Conclusion: The positive changes support the effectiveness of Time to Change but cannot be definitively attributed to it. Inequalities in stigma by demographic characteristics present targets for research and intervention.
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http://dx.doi.org/10.1093/eurpub/ckaa013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7292343PMC
June 2020

A study protocol to assess the feasibility of conducting an evaluation trial of the ADVANCE integrated intervention to address both substance use and intimate partner abuse perpetration to men in substance use treatment.

Pilot Feasibility Stud 2020 11;6:62. Epub 2020 May 11.

9School of Health in Social Science, University of Edinburgh, 8-9 Hope Park Square, Edinburgh, 8HQ 9NW UK.

Background: Strong evidence exists that substance use is a contributory risk factor for intimate partner abuse (IPA) perpetration. Men in substance use treatment are more likely to perpetrate IPA than men from the general population. Despite this, referral pathways are lacking for this group. This trial will assess the feasibility of conducting an evaluation trial of a tailored integrated intervention to address substance use and IPA perpetration to men in substance use treatment.

Methods/design: ADVANCE is a multicentre, parallel-group individually randomised controlled feasibility trial, with a nested formative evaluation, comparing an integrated intervention to reduce IPA + substance use treatment as usual (TAU) to TAU only. One hundred and eight men who have perpetrated IPA in the past 12 months from community substance use treatment in London, the West Midlands, and the South West will be recruited. ADVANCE is a manualised intervention comprising 2-4 individual sessions (2 compulsory) with a keyworker to set goals, develop a personal safety plan and increase motivation and readiness, followed by a 12-session weekly group intervention delivered in substance use services. Men will be randomly allocated (ratio 1:1) to receive the ADVANCE intervention + TAU or TAU only. Men's female (ex) partners will be invited to provide outcome data and offered support from integrated safety services (ISS). Regular case management meetings between substance use and ISS will manage risk. Outcome measures will be obtained at the end of the intervention (approximately 4 months post-randomisation) for all male and female participants. The main objective of this feasibility trial is to estimate parameters required for planning a definitive trial including rates of consent, recruitment, and follow-up by site and group allocation. Nested formative evaluation including focus groups and in-depth interviews will explore the intervention's acceptability to participants, group facilitators, keyworkers and ISS workers. Secondary outcomes include substance use, IPA, mental health, self-management, health and social care service use, criminal justice contacts, and quality of life.

Discussion: Findings from this feasibility trial will inform the design of a multicentre randomised controlled trial evaluating the efficacy and cost-effectiveness of the ADVANCE intervention for reducing IPA and improving the well-being of female (ex)partners.

Trial Registration: ISRCTN79435190.
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http://dx.doi.org/10.1186/s40814-020-00580-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7212681PMC
May 2020

Time to Change's social marketing campaign for a new target population: results from 2017 to 2019.

BMC Psychiatry 2019 12 27;19(1):417. Epub 2019 Dec 27.

Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.

Background: Since 2009 Time to Change has included among its strategies a social marketing campaign to tackle the stigma surrounding mental health problems. At the start of its third phase (2016-2021) the target group of the campaign was kept as people aged between mid-twenties and mid-forties but changed to middle-low income groups and the content was focused on men.

Methods: Participants (n = 3700) were recruited through an online market research panel, before and after each burst of the campaign. They completed an online questionnaire evaluating knowledge (Mental Health Knowledge Schedule, MAKS); attitudes (Community Attitudes toward Mental Illness, CAMI); and desire for social distance (Intended Behaviour subscale of the Reported and Intended Behaviour Scale, RIBS). Socio-demographic data and awareness of the campaign were also collected.

Results: For each of the 3 bursts, significant pre-post awareness differences were found (OR = 2.83, CI = 1.90-4.20, p < 0.001; OR = 1.72, CI = 1.22-2.42, p = 0.002; OR = 1.41, CI = 1.01-1.97, p = 0.043), and awareness at the end of the third burst was 33%. Demographic factors associated with awareness for one or more bursts included having children, familiarity with mental illness, male sex, being Black, Asian or other ethnic minorities and living in London or the East Midlands regions. An improvement across bursts in the "living with" subscale item of the RIBS, and in the "recover" and "advice to a friend" MAKS items were found. Familiarity with mental illness had the strongest association with all outcome measures, while the awareness of the campaign was also related with higher scores in MAKS and RIBS.

Conclusions: These interim results suggest that the campaign is reaching and having an impact on its new target audience to a similar extent as did the TTC phase 1 campaign. While over the course of TTC we have found no evidence that demographic differences in stigma have widened, and indeed those by age group and region of England have narrowed, those for socioeconomic status, ethnicity and sex have so far remained unchanged. By targeting a lower socioeconomic group and creating relatively greater awareness among men and in Black and ethnic minority groups, the campaign is showing the potential to address these persistent differences in stigma.
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http://dx.doi.org/10.1186/s12888-019-2415-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6933720PMC
December 2019

Hypoglycaemia Awareness Restoration Programme for People with Type 1 Diabetes and Problematic Hypoglycaemia Persisting Despite Optimised Self-care (HARPdoc): protocol for a group randomised controlled trial of a novel intervention addressing cognitions.

BMJ Open 2019 06 16;9(6):e030356. Epub 2019 Jun 16.

Department of Biostatistics, Department of Health Services and Population Research, Institute of Psychiatry Psychology and Neuroscience, London, UK.

Introduction: Severe hypoglycaemia (SH), when blood glucose falls too low to support brain function, is the most feared acute complication of insulin therapy for type 1 diabetes mellitus (T1DM). 10% of people with T1DM contribute nearly 70% of all episodes, with impaired awareness of hypoglycaemia (IAH) a major risk factor. People with IAH may be refractory to conventional approaches to reduce SH, with evidence for cognitive barriers to hypoglycaemia avoidance. This paper describes the protocol for the Hypoglycaemia Awareness Restoration Programme for People with Type 1 Diabetes and Problematic Hypoglycaemia Persisting Despite Optimised Self-care (HARPdoc) study, a trial to assess the impact on hypoglycaemia experience of a novel intervention that addresses cognitive barriers to hypoglycaemia avoidance, compared with an existing control intervention, recommended by the National Institute of Health and Care Excellence.

Methods And Analysis: A randomised parallel two-arm trial of two group therapies: HARPdoc versus Blood Glucose Awareness Training, among 96 adults with T1DM and problematic hypoglycaemia, despite attendance at education with or without technology use, in four centres providing specialist T1DM services. The primary outcome will be the SH rate at 12 and/or 24 months after randomisation to either course. Secondary outcomes include rates of SH requiring parenteral therapy, involving unconsciousness or needing emergency services; hypoglycaemia awareness status, overall diabetes control and quality of life measures. An implementation study to evaluate how the interventions are delivered and how implementation impacts on clinical effectiveness is planned as a parallel study, with its own protocol.

Ethics And Dissemination: The protocol was approved by the London Dulwich Research Ethics Committee, the Health Research Authority, National Health Service R&D and the Institutional Review Board of the Joslin Diabetes Center in the USA. Study findings will be disseminated to study participants and through peer-reviewed publications and conference presentations, including user groups.

Trial Registration Number: NCY02940873; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2019-030356DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6588968PMC
June 2019

Protocol for a quasi-experimental study of the effectiveness and cost-effectiveness of mother and baby units compared with general psychiatric inpatient wards and crisis resolution team services (The ESMI study) in the provision of care for women in the postpartum period.

BMJ Open 2019 03 23;9(3):e025906. Epub 2019 Mar 23.

Section of Women's Mental Health, Institute of Psychiatry, Psychology & Neuroscience at King's College London, London, UK.

Introduction: Research into what constitutes the best and most effective care for women with an acute severe postpartum mental disorder is lacking. The effectiveness and cost-effectiveness of psychiatric mother and baby units (MBUs) has not been investigated systematically and there has been no direct comparison of the outcomes of mothers and infants admitted to these units, compared with those accessing generic acute psychiatric wards or crisis resolution teams (CRTs). Our primary hypothesis is that women with an acute psychiatric disorder, in the first year after giving birth, admitted to MBUs are significantly less likely to be readmitted to acute care (an MBU, CRTs or generic acute ward) in the year following discharge than women admitted to generic acute wards or cared for by CRTs.

Methods And Analysis: Quasi-experimental study of women accessing different types of acute psychiatric services in the first year after childbirth. Analysis of the primary outcome will be compared across the three service types, at 1-year postdischarge. Cost-effectiveness will be compared across the three service types, at 1-month and 1-year postdischarge; explored in terms of quality-adjusted life years. Secondary outcomes include unmet needs, service satisfaction, maternal adjustment, quality of mother-infant interaction. Outcomes will be analysed using propensity scoring to account for systematic differences between MBU and non-MBU participants. Analyses will take place separately within strata, defined by the propensity score, and estimates pooled to produce an average treatment effect with weights to account for cohort attrition.

Ethics And Dissemination: The study has National Health Service (NHS) Ethics Approval and NHS Trust Research and Development approvals. The study has produced protocols on safeguarding maternal/child welfare. With input from our lived experience group, we have developed a dissemination strategy for academics/policy-makers/public.
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http://dx.doi.org/10.1136/bmjopen-2018-025906DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6475160PMC
March 2019

Response to the editorial by Dr Geraghty.

J Health Psychol 2017 08 24;22(9):1113-1117. Epub 2017 Jan 24.

12 Western General Hospital, UK.

This article is written in response to the linked editorial by Dr Geraghty about the adaptive Pacing, graded Activity and Cognitive behaviour therapy; a randomised Evaluation (PACE) trial, which we led, implemented and published. The PACE trial compared four treatments for people diagnosed with chronic fatigue syndrome. All participants in the trial received specialist medical care. The trial found that adding cognitive behaviour therapy or graded exercise therapy to specialist medical care was as safe as, and more effective than, adding adaptive pacing therapy or specialist medical care alone. Dr Geraghty has challenged these findings. In this article, we suggest that Dr Geraghty's views are based on misunderstandings and misrepresentations of the PACE trial; these are corrected.
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http://dx.doi.org/10.1177/1359105316688953DOI Listing
August 2017

Biochemical and Psychological Effects of Omega-3/6 Supplements in Male Adolescents with Attention-Deficit/Hyperactivity Disorder: A Randomized, Placebo-Controlled, Clinical Trial.

J Child Adolesc Psychopharmacol 2015 Dec;25(10):775-82

1 Department of Adolescent and Child Psychiatry, Institute of Psychiatry , Psychology and Neuroscience, London, United Kingdom .

Background: An abnormality in long chain-polyunsaturated fatty acid (LC-PUFA) levels has been implicated in attention-deficit/hyperactivity disorder (ADHD). Studies evaluating LC-PUFA supplementation for therapeutic efficacy in ADHD have shown mixed and, therefore, inconclusive results.

Methods: Seventy-six male adolescents (age 12-16 years, mean = 13.7) with ADHD were assessed for the effects of 12 weeks omega-3 and omega-6 supplements on biochemical and psychological outcomes in a randomized, placebo-controlled, clinical trial. The primary outcome measure was change in the Conners' Teacher Rating Scales (CTRS) following 12 weeks of supplementation of LC-PUFA or placebo. At baseline, the placebo and treatment groups had comparable levels of LC-PUFA as measured by red blood cell phosphatidylcholine. In the treatment group, supplementation enhanced eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and total omega-3 fatty acid levels.

Results: No superiority of LC-PUFAs to placebo was observed on the primary outcome. Further, there were no reliable treatment effects on aggression, impulsivity, depression, and anxiety.

Conclusions: Future studies should use larger sample sizes and longer supplementation period to detect small-modest effects for clinical recommendations in ADHD.
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http://dx.doi.org/10.1089/cap.2015.0052DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4691649PMC
December 2015

A randomised trial of adaptive pacing therapy, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome (PACE): statistical analysis plan.

Trials 2013 Nov 13;14:386. Epub 2013 Nov 13.

MH&N Clinical Trials Unit, Institute of Psychiatry, King's College London, DeCrespigny Park, London SE5 8AF, UK.

Background: The publication of protocols by medical journals is increasingly becoming an accepted means for promoting good quality research and maximising transparency. Recently, Finfer and Bellomo have suggested the publication of statistical analysis plans (SAPs).The aim of this paper is to make public and to report in detail the planned analyses that were approved by the Trial Steering Committee in May 2010 for the principal papers of the PACE (Pacing, graded Activity, and Cognitive behaviour therapy: a randomised Evaluation) trial, a treatment trial for chronic fatigue syndrome. It illustrates planned analyses of a complex intervention trial that allows for the impact of clustering by care providers, where multiple care-providers are present for each patient in some but not all arms of the trial.

Results: The trial design, objectives and data collection are reported. Considerations relating to blinding, samples, adherence to the protocol, stratification, centre and other clustering effects, missing data, multiplicity and compliance are described. Descriptive, interim and final analyses of the primary and secondary outcomes are then outlined.

Conclusions: This SAP maximises transparency, providing a record of all planned analyses, and it may be a resource for those who are developing SAPs, acting as an illustrative example for teaching and methodological research. It is not the sum of the statistical analysis sections of the principal papers, being completed well before individual papers were drafted.

Trial Registration: ISRCTN54285094 assigned 22 May 2003; First participant was randomised on 18 March 2005.
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http://dx.doi.org/10.1186/1745-6215-14-386DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4226009PMC
November 2013

Supervised injectable heroin or injectable methadone versus optimised oral methadone as treatment for chronic heroin addicts in England after persistent failure in orthodox treatment (RIOTT): a randomised trial.

Lancet 2010 May;375(9729):1885-95

King's College London, National Addiction Centre, London, UK.

Background: Some heroin addicts persistently fail to benefit from conventional treatments. We aimed to compare the effectiveness of supervised injectable treatment with medicinal heroin (diamorphine or diacetylmorphine) or supervised injectable methadone versus optimised oral methadone for chronic heroin addiction.

Methods: In this multisite, open-label, randomised controlled trial, we enrolled chronic heroin addicts who were receiving conventional oral treatment (>or=6 months), but continued to inject street heroin regularly (>or=50% of days in preceding 3 months). Randomisation by minimisation was used to assign patients to receive supervised injectable methadone, supervised injectable heroin, or optimised oral methadone. Treatment was provided for 26 weeks in three supervised injecting clinics in England. Primary outcome was 50% or more of negative specimens for street heroin on weekly urinalysis during weeks 14-26. Primary analysis was by intention to treat; data were adjusted for centre, regular crack use at baseline, and treatment with optimised oral methadone at baseline. Percentages were calculated with Rubin's rules and were then used to estimate numbers of patients in the multiple imputed samples. This study is registered, ISRCTN01338071.

Findings: Of 301 patients screened, 127 were enrolled and randomly allocated to receive injectable methadone (n=42 patients), injectable heroin (n=43), or oral methadone (n=42); all patients were included in the primary analysis. At 26 weeks, 80% (n=101) patients remained in assigned treatment: 81% (n=34) on injectable methadone, 88% (n=38) on injectable heroin, and 69% (n=29) on oral methadone. Patients on injectable heroin were significantly more likely to have achieved the primary outcome (72% [n=31]) than were those on oral methadone (27% [n=11], OR 7.42, 95% CI 2.69-20.46, p<0.0001; adjusted: 66% [n=28] vs 19% [n=8], 8.17, 2.88-23.16, p<0.0001), with number needed to treat of 2.17 (95% CI 1.60-3.97). For injectable methadone (39% [n=16]; adjusted: 30% [n=14]) versus oral methadone, the difference was not significant (OR 1.74, 95% CI 0.66-4.60, p=0.264; adjusted: 1.79, 0.67-4.82, p=0.249). For injectable heroin versus injectable methadone, a significant difference was recorded (4.26, 1.63-11.14, p=0.003; adjusted: 4.57, 1.71-12.19, p=0.002), but the study was not powered for this comparison. Differences were evident within the first 6 weeks of treatment.

Interpretation: Treatment with supervised injectable heroin leads to significantly lower use of street heroin than does supervised injectable methadone or optimised oral methadone. UK Government proposals should be rolled out to support the positive response that can be achieved with heroin maintenance treatment for previously unresponsive chronic heroin addicts.

Funding: Community Fund (Big Lottery) Research section, through Action on Addiction.
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http://dx.doi.org/10.1016/S0140-6736(10)60349-2DOI Listing
May 2010

Impacts of climate change on indirect human exposure to pathogens and chemicals from agriculture.

Cien Saude Colet 2010 May;15(3):743-56

CSL, EcoChemistry Team, University of York, York, UK, YO41 1LZ.

Climate change is likely to affect the nature of pathogens/ chemicals in the environment and their fate and transport. We assess the implications of climate change for changes in human exposures to pathogens/chemicals in agricultural systems in the UK and discuss the effects on health impacts, using expert input and literature on climate change; health effects from exposure to pathogens/chemicals arising from agriculture; inputs of chemicals/pathogens to agricultural systems; and human exposure pathways for pathogens/chemicals in agricultural systems. We established the evidence base for health effects of chemicals/pathogens in the agricultural environment; determined the potential implications of climate change on chemical/pathogen inputs in agricultural systems; and explored the effects of climate change on environmental transport and fate of various contaminants. We merged data to assess the implications of climate change in terms of indirect human exposure to pathogens/chemicals in agricultural systems, and defined recommendations on future research and policy changes to manage adverse increases in risks.
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http://dx.doi.org/10.1590/s1413-81232010000300017DOI Listing
May 2010

A randomised controlled trial of a worry intervention for individuals with persistent persecutory delusions.

J Behav Ther Exp Psychiatry 2010 Mar 17;41(1):45-51. Epub 2009 Sep 17.

Department of Psychology, Institute of Psychiatry, King's College London, Denmark Hill, UK.

Recent research has shown that worry is associated with distressing paranoia. Therefore, the aim was to target worry in a therapeutic intervention for individuals with delusions. It was predicted that a worry intervention would reduce levels of worry and paranoia distress. Twenty-four individuals with persistent persecutory delusions and high levels of worry were randomly assigned to receive a four session cognitive-behavioural worry intervention (W-CBT) or treatment as usual (TAU). The worry intervention was specifically designed not to target the content of delusions. In this open-label evaluation, assessments of worry and paranoia were conducted at baseline, at one month (end of treatment) and at two months. The worry intervention achieved a statistically significant reduction in worry which was maintained at two month follow up. A significant reduction in delusional distress was also reported. There was an indication that the worry intervention may also reduce the frequency of paranoid thoughts but this was not statistically significant. In the first trial specifically for persecutory delusions, a brief worry intervention was shown to have benefits. The results support a causal role for worry in paranoid experience.
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http://dx.doi.org/10.1016/j.jbtep.2009.09.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2828542PMC
March 2010

Mortality associated with attention-deficit hyperactivity disorder (ADHD) drug treatment: a retrospective cohort study of children, adolescents and young adults using the general practice research database.

Drug Saf 2009 ;32(11):1089-96

Centre for Paediatric Pharmacy Research, The School of Pharmacy, University of London and The Institute of Child Health, University College London, London, UK.

Background: Following reports of sudden death in patients taking medication to treat attention-deficit hyperactivity disorder (ADHD), this study aimed to identify cases of death in patients prescribed stimulants and atomoxetine and to determine any association between these and sudden death.

Method: The UK General Practice Research Database (GPRD) was used to identify patients aged 2-21 years from 1 January 1993 to 30 June 2006 with a prescription for methylphenidate, dexamfetamine or atomoxetine. Patients were followed from the date of first prescription until whichever came first: date of death, transferred-out date, age >21 years or end of the study period.

Results: From a cohort of 18 637 patient-years, seven patients died. Cause of death was obtained for six of the patients. None were deemed to be cases of sudden death. Compared with a general population rate of sudden death in the literature, the worst-case scenario of one case of sudden death gave an incident rate ratio of 1.63 (95% CI 0.04, 9.71). Although it was not the primary outcome of the study, following reports of suicide in the cohort the standardized mortality ratio (SMR) of suicide was calculated. Due to differences in the definition of suicide used for children and adults, patients were categorized into two age groups: 11-14 years and 15-21 years. The SMR for suicide for patients aged 11-14 years was 161.91 (95% CI 19.61, 584.88). The SMR for suicide for patients aged 15-21 years was 1.84 (95% CI 0.05, 10.25).

Conclusion: This study demonstrated no increase in the risk of sudden death associated with stimulants or atomoxetine. However, an increased risk of suicide was seen. Although we cannot exclude that the medications may contribute to the increased risk of suicide, there are other factors such as depression and antisocial behaviour that frequently co-exist with ADHD, which can also predispose to teenage suicide. Clinicians should identify patients at increased risk of cardiovascular events and identify those patients at increased risk of suicide, particularly males with co-morbid conditions, and monitor them appropriately.
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http://dx.doi.org/10.2165/11317630-000000000-00000DOI Listing
December 2009

Impacts of climate change on indirect human exposure to pathogens and chemicals from agriculture.

Environ Health Perspect 2009 Apr 10;117(4):508-14. Epub 2008 Dec 10.

EcoChemistry Team, University of York, Heslington, York, United Kingdom.

Objective: Climate change is likely to affect the nature of pathogens and chemicals in the environment and their fate and transport. Future risks of pathogens and chemicals could therefore be very different from those of today. In this review, we assess the implications of climate change for changes in human exposures to pathogens and chemicals in agricultural systems in the United Kingdom and discuss the subsequent effects on health impacts.

Data Sources: In this review, we used expert input and considered literature on climate change; health effects resulting from exposure to pathogens and chemicals arising from agriculture; inputs of chemicals and pathogens to agricultural systems; and human exposure pathways for pathogens and chemicals in agricultural systems.

Data Synthesis: We established the current evidence base for health effects of chemicals and pathogens in the agricultural environment; determined the potential implications of climate change on chemical and pathogen inputs in agricultural systems; and explored the effects of climate change on environmental transport and fate of different contaminant types. We combined these data to assess the implications of climate change in terms of indirect human exposure to pathogens and chemicals in agricultural systems. We then developed recommendations on future research and policy changes to manage any adverse increases in risks.

Conclusions: Overall, climate change is likely to increase human exposures to agricultural contaminants. The magnitude of the increases will be highly dependent on the contaminant type. Risks from many pathogens and particulate and particle-associated contaminants could increase significantly. These increases in exposure can, however, be managed for the most part through targeted research and policy changes.
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http://dx.doi.org/10.1289/ehp.0800084DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2679592PMC
April 2009

Attention-deficit hyperactivity disorder: treatment discontinuation in adolescents and young adults.

Br J Psychiatry 2009 Mar;194(3):273-7

Centre for Paediatric Pharmacy Research, School of Pharmacy, University of London and Institute of Child Health, University College London, UK.

Background: Symptoms of attention-deficit hyperactivity disorder (ADHD) are known to persist into adulthood in the majority of cases.

Aims: To determine the prevalence of methylphenidate, dexamfetamine and atomoxetine prescribing and treatment discontinuation in adolescents and young adults.

Method: A descriptive cohort study using the UK General Practice Research Database included patients aged 15-21 years from 1999 to 2006 with a prescription for a study drug.

Results: Prevalence of prescribing averaged across all ages increased 6.23-fold over the study period. Overall, prevalence decreased with age: in 2006, prevalence in males dropped 95% from 12.77 per 1000 in 15-year-olds to 0.64 per 1000 in 21-year-olds. A longitudinal analysis of a cohort of 44 patients aged 15 years in 1999 demonstrated that no patient received treatment after the age of 21 years.

Conclusions: The prevalence of prescribing by general practitioners to patients with ADHD drops significantly from age 15 to age 21 years. The fall in prescribing is greater than the reported age-related decrease in symptoms, raising the possibility that treatment is prematurely discontinued in some young adults in whom symptoms persist.
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http://dx.doi.org/10.1192/bjp.bp.107.045245DOI Listing
March 2009