The influence of demographic, health and psychosocial factors on patient uptake of the English NHS diabetes prevention programme.

BACKGROUND: The prevention of type 2 diabetes (T2DM) is a major concern for health services around the world. The English NHS Diabetes Prevention Programme (NHS-DPP) offers a group face-to-face behaviour change intervention, based around exercise and diet, to adults with non-diabetic hyperglycaemia (NDH), referred from primary care. Previous analysis of the first 100,000 referrals revealed just over half of those referred to the NHS-DPP took up a place. This study aimed to identify the demographic, health and psychosocial factors associated with NHS-DPP uptake to help inform the development of interventions to improve uptake and address inequities between population groups. METHODS: Drawing on the Behavioral Model of Health Services Utilization we developed a survey questionnaire to collect data on a wide range of demographic, health and psychosocial factors that might influence uptake of the NHS-DPP. We distributed this questionnaire to a cross-sectional random sample of 597 patients referred to the NHS-DPP across 17 general practices, chosen for variation. Multivariable regression analysis was used to identify factors associated with NHS-DPP uptake. RESULTS: 325 out of 597 questionnaires were completed (54%). Only a third of responders took up the offer of a place. The best performing model for uptake (AUC = 0.78) consisted of four factors: older age; beliefs concerning personal vulnerability to T2DM; self-efficacy for reducing T2DM risk; and the efficacy of the NHS-DPP. After accounting for these, demographic and health-related factors played only a minor role. CONCLUSION: Unlike fixed demographic characteristics, psychosocial perceptions may be amenable to change. NHS-DPP uptake rates may be improved by targeting the beliefs of patients about their risk of developing T2DM, their ability to carry out and sustain behaviours to reduce this risk, and the efficacy of the NHS-DPP in providing the necessary understanding and skills required. The recently introduced digital version of the NHS DPP could help address the even lower uptake amongst younger adults. Such changes could facilitate proportional access from across different demographic strata.

Retrospective study of more than 5 million emergency admissions to hospitals in England: Epidemiology and outcomes for people with dementia.

INTRODUCTION: People living with dementia (PwD) admitted in emergency to an acute hospital may be at higher risk of inappropriate care and poorer outcomes including longer hospitalisations and higher risk of emergency re-admission or death. Since 2009 numerous national and local initiatives in England have sought to improve hospital care for PwD. We compared outcomes of emergency admissions for cohorts of patients aged 65+ with and without dementia at three points in time. METHODS: We analysed emergency admissions (EAs) from the Hospital Episodes Statistics datasets for England 2010/11, 2012/13 and 2016/17. Dementia upon admission was based on a diagnosis in the patient's hospital records within the last five years. Outcomes were length of hospital stays (LoS), long stays (> = 15 days), emergency re-admissions (ERAs) and death in hospital or within 30 days post-discharge. A wide range of covariates were taken into account, including patient demographics, pre-existing health and reasons for admission. Hierarchical multivariable regression analysis, applied separately for males and females, estimated group differences adjusted for covariates. RESULTS: We included 178 acute hospitals and 5,580,106 EAs, of which 356,992 (13.9%) were male PwD and 561,349 (18.6%) female PwD. Uncontrolled differences in outcomes between the patient groups were substantial but were considerably reduced after control for covariates. Covariate-adjusted differences in LoS were similar at all time-points and in 2016/17 were 17% (95%CI 15%-18%) and 12% (10%-14%) longer for male and female PwD respectively compared to patients without dementia. Adjusted excess risk of an ERA for PwD reduced over time to 17% (15%-18%) for males and 17% (16%-19%) for females, but principally due to increased ERA rates amongst patients without dementia. Adjusted overall mortality was 30% to 40% higher for PwD of both sexes throughout the time-period; however, adjusted in-hospital rates of mortality differed only slightly between the patient groups, whereas PwD had around double the risk of dying within 30 days of being discharged. CONCLUSION: Over the six-year period, covariate-adjusted hospital LoS, ERA rates and in-hospital mortality rates for PwD were only slightly elevated compared to similar patients without dementia and remaining differences potentially reflect uncontrolled confounding. PwD however, were around twice as likely to die shortly after discharge, the reasons for which require further investigation. Despite being widely used for service evaluation, LoS, ERA and mortality may lack sensitivity to changes in hospital care and support to PwD.

Development and validation of the Montreal cognitive assessment for people with hearing impairment (MoCA-H).

BACKGROUND: Hearing impairment is common among older adults and affects cognitive assessments for identification of dementia which rely on good hearing function. We developed and validated a version of the Montreal Cognitive Assessment (MoCA) for people with hearing impairment. METHODS: We adapted existing MoCA 8.1 items for people with hearing impairment by presenting instructions and stimuli in written rather than spoken format. One Attention domain and two Language domain items required substitution by alternative items. Three and four candidate items respectively were constructed and field-tested along with the items adapted to written form. We used a combination of individual item analysis and item substitution to select the set of alternative items to be included in the final form of the MoCA-H in place of the excluded original items. We then evaluated the performance and reliability of the final tool, including making any required adjustments for demographic factors. RESULTS: One hundred and fifty-nine hearing-impaired participants, including 76 with normal cognition and 83 with dementia, completed the adapted version of the MoCA. A further 97 participants with normal hearing completed the standard MoCA as well as the novel items developed for the MoCA-H to assess score equivalence between the existing and alternative MoCA items and for independence from hearing impairment. Twenty-eight participants were retested between 2-4 weeks after initial testing. After the selection of optimal item set, the final MoCA-H had an area under the curve of 0.973 (95% CI 0.952-0.994). At a cut-point of 24 points or less sensitivity and specificity for dementia was 92.8% and 90.8%, respectively. The intraclass correlation for test-retest reliability was 0.92 (95%CI 0.78-0.97). CONCLUSION: The MoCA-H is a sensitive and reliable means of identifying dementia among adults with acquired hearing impairment.

Information about fetal movements and stillbirth trends: Analysis of time series data.

OBJECTIVE: To investigate the implementation of the Count the Kicks campaign in Iowa to increase maternal awareness of fetal movements and its association with stillbirth rates. DESIGN: Time series analysis. SETTING: Iowa, Illinois, Minnesota and Missouri, USA. SAMPLE: Women giving birth between 2005 and 2018. METHODS: Data regarding campaign activity, including uptake of the app and the distribution of information materials, and population-level data on stillbirth rates and potential confounding risk factors were obtained from publicly available data for 2005-2018. Data were plotted over time and examined in relation to key implementation phases. MAIN OUTCOME MEASURE: Stillbirth. RESULTS: App users were largely centred on Iowa, and increased over time, although the numbers were modest relative to the number of births. Only Iowa demonstrated a reduction in stillbirth (OR 0.96, 95% CI 0.96-1.00 per year; interaction between state and time, p < 0.001); there was a decline from 2008 to 2013 (before the launch of the app), an increase from 2014 to 2016 and a decrease from 2017 to 2018, which coincided with increased app use (interaction between period and time, p = 0.06). With the exception of smoking (which fell from approx. 20% in 2005 to approx. 15% in 2018 in Iowa), all risk factors increased in prevalence, so are unlikely to account for a reduction in stillbirth. CONCLUSIONS: There was a reduction in the stillbirth rate in Iowa, where an information campaign about fetal movements was active; this reduction was not present in neighbouring states. Large-scale intervention studies are needed to determine whether the temporal associations between app use and stillbirth rate are causally related.

Digital Interventions Supporting Self-care in People With Type 2 Diabetes Across Greater Manchester (Greater Manchester Diabetes My Way): Protocol for a Mixed Methods Evaluation.

BACKGROUND: Type 2 Diabetes (T2D) is common, with a prevalence of approximately 7% of the population in the United Kingdom. The quality of T2D care is inconsistent across the United Kingdom, and Greater Manchester (GM) does not currently achieve the National Institute for Health and Care Excellence treatment targets. Barriers to delivery of care include low attendance and poor engagement with local T2D interventions, which tend to consist of programs of education delivered in traditional, face-to-face clinical settings. Thus, a flexible approach to T2D management that is accessible to people from different backgrounds and communities is needed. Diabetes My Way (DMW) is a digital platform that offers a comprehensive self-management and educational program that should be accessible to a wide range of people through mobile apps and websites. Building on evidence generated by a Scotland-wide pilot study, DMW is being rolled out and tested across GM. OBJECTIVE: The overarching objectives are to assess whether DMW improves outcomes for patients with T2D in the GM area, to explore the acceptability of the DMW intervention to stakeholders, and to assess the cost-effectiveness of the intervention. METHODS: A mixed methods approach will be used. We will take a census approach to recruitment in that all eligible participants in GM will be invited to participate. The primary outcomes will be intervention-related changes compared with changes observed in a matched group of controls, and the secondary outcomes will be within-person intervention-related changes. The cost-effectiveness analysis will focus on obtaining reliable estimates of how each intervention affects risk factors such as HbA1c and costs across population groups. Qualitative data will be collected via semistructured interviews and focus groups and organized using template analysis. RESULTS: As of May 10, 2021, a total of 316 participants have been recruited for the quantitative study and have successfully enrolled. A total of 278 participants attempted to register but did not have appropriate permissions set by the general practitioners to gain access to their data. In total, 10 participants have been recruited for the qualitative study (7 practitioners and 3 patients). An extension to recruitment has been granted for the quantitative element of the research, and analysis should be complete by December 2022. Recruitment and analysis for the qualitative study should be complete by December 2021. CONCLUSIONS: The findings from this study can be used both to develop the DMW system and improve accessibility and usability in more deprived populations generally, thus improving equity in access to support for T2D self-management. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/26237.

Incidence, origins and avoidable harm of missed opportunities in diagnosis: longitudinal patient record review in 21 English general practices.

BACKGROUND: Diagnostic error is a global patient safety priority. OBJECTIVES: To estimate the incidence, origins and avoidable harm of diagnostic errors in English general practice. Diagnostic errors were defined as missed opportunities to make a correct or timely diagnosis based on the evidence available (missed diagnostic opportunities, MDOs). METHOD: Retrospective medical record reviews identified MDOs in 21 general practices. In each practice, two trained general practitioner reviewers independently conducted case note reviews on 100 randomly selected adult consultations performed during 2013-2014. Consultations where either reviewer identified an MDO were jointly reviewed. RESULTS: Across 2057 unique consultations, reviewers agreed that an MDO was possible, likely or certain in 89 cases or 4.3% (95% CI 3.6% to 5.2%) of reviewed consultations. Inter-reviewer agreement was higher than most comparable studies (Fleiss' kappa=0.63). Sixty-four MDOs (72%) had two or more contributing process breakdowns. Breakdowns involved problems in the patient-practitioner encounter such as history taking, examination or ordering tests (main or secondary factor in 61 (68%) cases), performance and interpretation of diagnostic tests (31; 35%) and follow-up and tracking of diagnostic information (43; 48%). 37% of MDOs were rated as resulting in moderate to severe avoidable patient harm. CONCLUSIONS: Although MDOs occurred in fewer than 5% of the investigated consultations, the high numbers of primary care contacts nationally suggest that several million patients are potentially at risk of avoidable harm from MDOs each year. Causes of MDOs were frequently multifactorial, suggesting the need for development and evaluation of multipronged interventions, along with policy changes to support them.

Developing the evidence base for evaluating dementia training in NHS hospitals (DEMTRAIN): a mixed-methods study protocol.

INTRODUCTION: Around 70% of acute hospital beds in the UK are occupied by older people, approximately 40% of whom have dementia. Improving the quality of care in hospitals is a key priority within national dementia strategies. Limited research has been conducted to evaluate dementia training packages for staff, and evaluation of training often focuses on immediate, on-the-day training feedback and effects. OBJECTIVES: Our study aims to answer two research questions: (1) How do variations in content, implementation and intensity of staff dementia training in acute hospitals in England relate to health service outcome/process measures and staff outcomes? and (2) What components of staff dementia training are most strongly related to improved patient and staff outcomes? METHODS AND ANALYSIS: Using the principles of programme theory, a mixed-method study will be used to identify mechanisms and the interactions between them, as well as facilitators and barriers to dementia training in hospitals. We will use existing data, such as Hospital Episode Statistics, alongside two surveys (at hospital and staff level).We will recruit up to 193 acute hospitals in England to participate in the hospital level survey. We aim to recruit up to 30 staff members per hospital, from a random sample of 24 hospitals. In addition, we will explore the cost-effectiveness of dementia training packages and carry out an in-depth case study of up to six hospitals. ETHICS AND DISSEMINATION: The study has been reviewed and approved by the Faculty of Health and Medicine Research Ethics Committee (FHMREC 17056) and Health Research Authority (Integrated Research Approval System (IRAS) ID 242166: REC reference 18/HRA/1198). We plan to develop both standard (eg, academic publications, presentations at conferences) and innovative (eg, citizen scientist web portals, online fora, links with hospitals and third sector organisations) means of ensuring the study findings are accessible and disseminated regionally, nationally and internationally.

Feasibility and acceptability of integrated psychological therapy versus treatment as usual for people with bipolar disorder and co-morbid alcohol use: A single blind randomised controlled trial.

BACKGROUND: Alcohol use is a common problem in bipolar disorder (BD) and evidence indicates more promising outcomes for alcohol use than other substances. No trials have evaluated individual integrated motivational interviewing and cognitive behaviour therapy (MI-CBT) for problematic alcohol use in BD. We therefore assessed the feasibility and acceptability of a novel MI-CBT intervention for alcohol use in BD. METHODS: A single blind RCT was conducted to compare MI-CBT plus treatment as usual (TAU) with TAU only. MI-CBT was delivered over 20 sessions with participants followed up at 3, 6, 9 and 12 months post-randomisation. Primary outcomes were the feasibility and acceptability of MI-CBT (recruitment to target, retention to follow-up and therapy, acceptability of therapy and absence of adverse events). We also conducted preliminary analyses of alcohol and mood outcomes (frequency and severity of alcohol use and time to mood relapse). RESULTS: 44 participants were recruited with 75% retention to 6 and 12 months follow-up. Therapy participants attended a mean of 17.6 (SD 4.5) sessions. Therapy alliance and treatment fidelity were acceptable. Qualitative interviews indicated the intervention was experienced as collaborative, and helpful, in addressing mood and alcohol issues, although risk of overconfidence following therapy was also identified. Clinical outcomes did not differ between arms at 12 months follow-up. LIMITATIONS: As a feasibility and acceptability trial any secondary results should be treated with caution. CONCLUSIONS: Integrated MI-CBT is feasible and acceptable, but lack of clinical impact, albeit in a feasibility study, suggests need for further development. Potential adaptations are discussed.

The feasibility and acceptability of a novel anxiety in bipolar disorder intervention compared to treatment as usual: A randomized controlled trial.

BACKGROUND: Comorbid anxiety is common in bipolar disorder (BD) and associated with worse clinical outcomes including increased suicidality. Despite effective psychological treatments for anxiety, research into treating anxiety in BD is underdeveloped. This paper describes a novel psychological intervention to address anxiety in context of bipolar disorder (AIBD). METHODS: Adults with BD and clinically significant anxiety symptoms were randomized to AIBD plus treatment as usual (TAU) or TAU alone. AIBD offered 10 sessions of psychological therapy using a formulation-based approach. Feasibility and acceptability were evaluated through recruitment, retention, therapy attendance, alliance, fidelity, and qualitative feedback. Clinical outcomes were assessed at baseline, 16, 48, and 80 weeks: interim assessments of relapse at 32 and 64 weeks. RESULTS: Seventy-two participants were recruited with 88% retention to 16 weeks and 74% to 80 weeks (similar between arms). Therapy participants attended x ¯ 7.7 (SD 2.8) sessions. Therapeutic alliance and therapy fidelity were acceptable. Qualitative interviews indicated that participants valued integrated support for anxiety with BD and coping strategies. Some suggested a longer intervention period. Clinical outcomes were not significantly different between arms up to 80 weeks follow-up. CONCLUSIONS: AIBD is feasible and acceptable but lack of impact on clinical outcomes indicates that adaptations are required. These are discussed in relation to qualitative feedback and recent literature published since the trial completed.

Developing a core outcome set for people living with dementia at home in their neighbourhoods and communities: study protocol for use in the evaluation of non-pharmacological community-based health and social care interventions.

BACKGROUND: The key aim of the study is to establish an agreed standardised core outcome set (COS) for use when evaluating non-pharmacological health and social care interventions for people living at home with dementia. METHODS/DESIGN: Drawing on the guidance and approaches of the Core Outcome Measures in Effectiveness Trials (COMET), this study uses a four-phase mixed-methods design: 1 Focus groups and interviews with key stakeholder groups (people living with dementia, care partners, relevant health and social care professionals, researchers and policymakers) and a review of the literature will be undertaken to build a long list of outcomes. 2 Two rounds of Delphi surveys will be used with key stakeholder groups. Statements for the Delphi surveys and participation processes will be developed and informed through substantial member involvement with people living with dementia and care partners. A consensus meeting will be convened with key participant groups to discuss the key findings and finalise the COS. 3 A systematic literature review will be undertaken to assess the properties of tools and instruments to assess components of the COS. Measurement properties, validity and reliability will be assessed using the Consensus-based Standards for the Selection of Health Measurement (COSMIN) and COMET guidance. 4 A stated preference survey will elicit the preferences of key stakeholders for the outcomes identified as important to measure in the COS. DISCUSSION: To the best of our knowledge, this study is the first to use a modified Delphi process to involve people living with dementia as a participant group. Though the study is confined to collecting data in the United Kingdom, use of the COS by researchers will enhance the comparability of studies evaluating non-pharmacological and community-based interventions. TRIAL REGISTRATION: The study is registered on the COMET initiative, registered in 2014 at comet-initiative.org .

Delivery of cognitive-behaviour therapy for psychosis: a service user preference trial.

BACKGROUND: Clinical guidelines recommend cognitive behaviour therapy (CBT) for people with psychosis, however, implementation is poor and not everyone wishes to engage with therapy. Understanding service user (SU) preferences for receiving such treatments is a priority for services. AIMS: To explore SU preferences and outcomes of different methods of delivering CBT for psychosis. METHOD: SUs experiencing psychosis could choose between treatment as usual (TAU); TAU plus telephone-delivered CBT with self-help, CBT recovery manual (TS); high support CBT (HS - TAU plus TS plus group sessions) or randomisation. Participants received their option of choice and were followed-up on several outcomes over 9 and 15 months. RESULTS: Of 89 people recruited, three chose to be randomised and 86 expressed a treatment preference (32 chose TAU, 34 chose TS, 23 chose HS). There were few differences between those who chose therapy compared to those who chose TAU. Those who had more positive impacts from their symptoms were significantly more likely to choose TAU. CONCLUSIONS: Most people had strong preferences about treatment delivery and a substantial number did not wish to receive additional therapy. These findings have to be considered when planning and allocating resources for people with psychosis.

'Do you mean I'm not whole?': Exploring the role of support in women's experiences of mastectomy without reconstruction.

This study explores the role of others in supporting younger women who opt not to reconstruct their breast post-mastectomy. Semi-structured interviews were conducted with six women diagnosed with breast cancer in their 30s/40s. The women lived in England, had been diagnosed a minimum of 5 years previously and had undergone unilateral mastectomy. An interpretative phenomenological analysis revealed three themes: Assuring the self: 'I'll love you whatever', Challenging the self: 'Do you mean I'm not whole?' and Accepting the self: 'I've come out the other side'. The women's experiences of positive support and challenges to their sense of self are discussed.

Ketamine augmentation of electroconvulsive therapy to improve neuropsychological and clinical outcomes in depression (Ketamine-ECT): a multicentre, double-blind, randomised, parallel-group, superiority trial.

BACKGROUND: The use of electroconvulsive therapy (ECT) is limited by concerns about its cognitive adverse effects. Preliminary evidence suggests that administering the glutamate antagonist ketamine with ECT might alleviate cognitive adverse effects and accelerate symptomatic improvement; we tested this in a randomised trial of low-dose ketamine. METHODS: In this multicentre, randomised, parallel-group study in 11 ECT suites serving inpatient and outpatient care settings in seven National Health Service trusts in the North of England, we recruited severely depressed patients, who were diagnosed as having unipolar or bipolar depressive episodes defined as moderate or severe by DSM-IV criteria, aged at least 18 years, and were able and willing to provide written consent to participate in the study. Patients were randomly assigned (1:1) to ketamine (0·5 mg/kg intravenous bolus) or saline adjunctive to the anaesthetic for the duration of their ECT course. Patients and assessment and ECT treatment teams were masked to treatment allocation, although anaesthetists administering the study medication were not. We analysed the primary outcome, Hopkins Verbal Learning Test-Revised delayed verbal recall (HVLT-R-DR) after four ECT treatments, using a Gaussian repeated measures model in all patients receiving the first ECT treatment. In the same population, safety was assessed by adverse effect monitoring. This trial was registered with International Standard Randomised Controlled Trial Number, number ISRCTN14689382. FINDINGS: Between early December, 2012, and mid-June, 2015, 628 patients were screened for eligibility, of whom 79 were randomly assigned to treatment (40 in the ketamine group vs 39 in the saline group). Ketamine (mean 5·17, SD 2·92), when compared with saline (5·54, 3·42), had no benefit on the primary outcome (HVLT-R-DR; difference in means -0·43 [95% CI -1·73 to 0·87]). 15 (45%) of 33 ketamine-treated patients compared with 10 (27%) of 37 patients receiving saline experienced at least one adverse event which included two (6%) of 33 patients who had ketamine-attributable transient psychological effects. Psychiatric adverse events were the most common in both groups (six [27%] of 22 adverse events in the ketamine group vs seven [54%] of 13 in the saline group). INTERPRETATION: No evidence of benefit for ketamine was found although the sample size used was small; however, the results excluded greater than a small to moderate benefit with 95% confidence. The results do not support the use of adjunctive low-dose ketamine in routine ECT treatment. FUNDING: National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme, an MRC and NIHR partnership.

Cognitive-behavioural therapy and short-term psychoanalytic psychotherapy versus brief psychosocial intervention in adolescents with unipolar major depression (IMPACT): a multicentre, pragmatic, observer-blind, randomised controlled trial.

BACKGROUND: Although there are effective psychological treatments for unipolar major depression in adolescents, whether or not one or more of the available therapies maintain reduced depressive symptoms 1 year after the end of treatment is not known. This is a non-trivial issue because maintaining lowered depressive symptoms below a clinical threshold level reduces the risk for diagnostic relapse into the adult years. OBJECTIVE: To determine whether or not either of two specialist psychological treatments, cognitive-behavioural therapy (CBT) or short-term psychoanalytic psychotherapy (STPP), is more effective than a reference brief psychosocial intervention (BPI) in maintaining reduction of depression symptoms in the year after treatment. DESIGN: Observer-blind, parallel-group, pragmatic superiority randomised controlled trial. SETTING: A total of 15 outpatient NHS clinics in the UK from East Anglia, north-west England and North London. PARTICIPANTS: Adolescents aged 11-17 years with Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition major depression including those with suicidality, depressive psychosis and conduct disorder. Patients were randomised using stochastic minimisation controlling for age, sex and self-reported depression sum score; 470 patients were randomised and 465 were included in the analyses. INTERVENTIONS: In total, 154 adolescents received CBT, 156 received STPP and 155 received BPI. The trial lasted 86 weeks and study treatments were delivered in the first 36 weeks, with 52 weeks of follow-up. MAIN OUTCOME MEASURES: Mean sum score on self-reported depressive symptoms (primary outcome) at final study assessment (nominally 86 weeks, at least 52 weeks after end of treatment). Secondary measures were change in mean sum scores on self-reported anxiety symptoms and researcher-rated Health of the Nation scales for children and adolescents measuring psychosocial function. Following baseline assessment, there were a further five planned follow-up reassessments at nominal time points of 6, 12, 52 and 86 weeks post randomisation. RESULTS: There were non-inferiority effects of CBT compared with STPP [treatment effect by final follow-up = -0.578, 95% confidence interval (CI) -2.948 to 4.104; p = 0.748]. There were no superiority effects for the two specialist treatments (CBT + STPP) compared with BPI (treatment effect by final follow-up = -1.898, 95% CI -4.922 to 1.126; p = 0.219). At final assessment there was no significant difference in the mean depressive symptom score between treatment groups. There was an average 49-52% reduction in depression symptoms by the end of the study. There were no differences in total costs or quality-of-life scores between treatment groups and prescribing a selective serotonin reuptake inhibitor (SSRI) during treatment or follow-up did not differ between the therapy arms and, therefore, did not mediate the outcome. CONCLUSIONS: The three psychological treatments differed markedly in theoretical and clinical approach and are associated with a similar degree of clinical improvement, cost-effectiveness and subsequent maintenance of lowered depressive symptoms. Both STPP and BPI offer an additional patient treatment choice, alongside CBT, for depressed adolescents attending specialist Child and Adolescent Mental Health Services. Further research should focus on psychological mechanisms that are associated with treatment response, the maintenance of positive effects, determinants of non-response and whether or not brief psychotherapies are of use in primary care and community settings. LIMITATIONS: Neither reason for SSRI prescribing or monitoring of medication compliance was controlled for over the course of the study, and the economic results were limited by missing data. TRIAL REGISTRATION: Current Controlled Trials ISRCTN83033550. FUNDING: This project was funded by the National Institute for Heath Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 12. See the National Institute for Heath Research Journals Library website for further project information. Funding was also provided by the Department of Health. The funders had no role in the study design, patient recruitment, data collection, analysis or writing of the study, any aspect pertinent to the study or the decision to submit to The Lancet.

Cognitive behavioural therapy and short-term psychoanalytical psychotherapy versus a brief psychosocial intervention in adolescents with unipolar major depressive disorder (IMPACT): a multicentre, pragmatic, observer-blind, randomised controlled superiority trial.

BACKGROUND: Psychological treatments for adolescents with unipolar major depressive disorder are associated with diagnostic remission within 28 weeks in 65-70% of patients. We aimed to assess the medium-term effects and costs of psychological therapies on maintenance of reduced depression symptoms 12 months after treatment. METHODS: We did this multicentre, pragmatic, observer-blind, randomised controlled superiority trial (IMPACT) at 15 National Health Service child and adolescent mental health service (CAMHS) clinics in three regions in England. Adolescent patients (aged 11-17 years) with a diagnosis of DSM IV major depressive disorder were randomly assigned (1:1:1), via a web-based randomisation service, to receive cognitive behavioural therapy (CBT) or short-term psychoanalytical therapy versus a reference brief psychological intervention. Randomisation was stochastically minimised by age, sex, self-reported depression sum score, and region. Patients and clinicians were aware of group allocation, but allocation was concealed from outcome assessors. Patients were followed up and reassessed at weeks 6, 12, 36, 52, and 86 post-randomisation. The primary outcome was self-reported depression symptoms at weeks 36, 52, and 86, as measured with the self-reported Mood and Feelings Questionnaire (MFQ). Because our aim was to compare the two psychological therapies with the brief psychosocial intervention, we first established whether CBT was inferior to short-term psychoanalytical psychotherapy for the same outcome. Primary analysis was by intention to treat. This trial is registered with Current Controlled Trials, number ISRCTN83033550. FINDINGS: Between June 29, 2010, and Jan 17, 2013, we randomly assigned 470 patients to receive the brief psychosocial intervention (n=158), CBT (n=155), or short-term psychoanalytical therapy (n=157); 465 patients comprised the intention-to-treat population. 392 (84%) patients had available data for primary analysis by the end of follow-up. Treatment fidelity and differentiation were established between the three interventions. The median number of treatment sessions differed significantly between patients in the brief psychosocial intervention group (n=6 [IQR 4-11]), CBT group (n=9 [5-14]), and short-term psychoanalytical therapy group (n=11 [5-23]; p<0·0001), but there was no difference between groups in the average duration of treatment (27·5 [SD 21·5], 24·9 [17·7], 27·9 [16·8] weeks, respectively; Kruskal-Wallis p=0·238). Self-reported depression symptoms did not differ significantly between patients given CBT and those given short-term psychoanalytical therapy at weeks 36 (treatment effect 0·179, 95% CI -3·731 to 4·088; p=0·929), 52 (0·307, -3·161 to 3·774; p=0·862), or 86 (0·578, -2·948 to 4·104; p=0·748). These two psychological treatments had no superiority effect compared with brief psychosocial intervention at weeks 36 (treatment effect -3·234, 95% CI -6·611 to 0·143; p=0·061), 52 (-2·806, -5·790 to 0·177; p=0·065), or 86 (-1·898, -4·922 to 1·126; p=0·219). Physical adverse events (self-reported breathing problems, sleep disturbances, drowsiness or tiredness, nausea, sweating, and being restless or overactive) did not differ between the groups. Total costs of the trial interventions did not differ significantly between treatment groups. INTERPRETATION: We found no evidence for the superiority of CBT or short-term psychoanalytical therapy compared with a brief psychosocial intervention in maintenance of reduced depression symptoms 12 months after treatment. Short-term psychoanalytical therapy was as effective as CBT and, together with brief psychosocial intervention, offers additional patient choice for psychological therapy, alongside CBT, for adolescents with moderate to severe depression who are attending routine specialist CAMHS clinics. FUNDING: National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme, and the Department of Health.

Accounting for reporting fatigue is required to accurately estimate incidence in voluntary reporting health schemes.

OBJECTIVE: Accurate estimation of the true incidence of ill-health is a goal of many surveillance systems. In surveillance schemes including zero reporting to remove ambiguity with nonresponse, reporter fatigue might increase the likelihood of a false zero case report in turn underestimating the true incidence rate and creating a biased downward trend over time. STUDY DESIGN AND SETTING: Multilevel zero-inflated negative binomial models were fitted to incidence case reports of three surveillance schemes running between 1996 and 2012 in the United Kingdom. Estimates of the true annual incidence rates were produced by weighting the reported number of cases by the predicted excess zero rate in addition to the within-scheme standard adjustment for response rate and the participation rate. RESULTS: Time since joining the scheme was associated with the odds of excess zero case reports for most schemes, resulting in weaker calendar trends. Estimated incidence rates (95% confidence interval) per 100,000 person years, were approximately doubled to 30 (21-39), 137 (116-157), 33 (27-39), when excess zero-rate adjustment was applied. CONCLUSION: If we accept that excess zeros are in reality nonresponse by busy reporters, then usual estimates of incidence are likely to be significantly underestimated and previously thought strong downward trends overestimated.

Clinical effectiveness and acceptability of structured group psychoeducation versus optimised unstructured peer support for patients with remitted bipolar disorder (PARADES): a pragmatic, multicentre, observer-blind, randomised controlled superiority trial.

BACKGROUND: Group psychoeducation is a low-cost National Institute for Health and Care Excellence-recommended treatment for bipolar disorder. However, the clinical effectiveness and acceptability of this intervention are unclear compared with unstructured peer support matched for delivery and aim of treatment, and for previous bipolar history. We aimed to assess the clinical effectiveness and acceptability of structured group psychoeducation versus optimised unstructured peer support for patients with remitted bipolar disorder. METHODS: We did this pragmatic, multicentre, parallel-group, observer-blind, randomised controlled superiority trial at eight community sites in two regions in England. Participants aged 18 years or older with bipolar disorder and no episode in the preceding 4 weeks were recruited via self-referral or secondary care referral. Participants were individually randomly assigned (1:1), via a computer-generated stochastic allocation sequence, to attend 21 2-h weekly sessions of either structured group psychoeducation or optimised unstructured peer support. Randomisation was minimised by number of previous episodes (one to seven, eight to 19, or ≥20) and stratified by clinical site. Outcome assessors were masked to group allocation. The primary outcome was time from randomisation to next bipolar episode, with planned moderator analysis of number of previous bipolar episodes and qualitative interview of participant experience. We did analysis by intention to treat. This trial is registered with the International Standard Randomised Controlled Trial registry, number ISRCTN62761948. FINDINGS: Between Sept 28, 2009, and Jan 9, 2012, we randomly assigned 304 participants to receive psychoeducation (n=153) or peer support (n=151); all (100%) participants had complete primary outcome data. Attendance at psychoeducation groups was higher than at peer-support groups (median 14 sessions [IQR three to 18] vs nine sessions [two to 17]; p=0·026). At 96 weeks, 89 (58%) participants in the psychoeducation group had experienced a next bipolar episode compared with 98 (65%) participants in the peer-support group; time to next bipolar episode did not differ between groups (hazard ratio [HR] 0·83, 95% CI 0·62-1·11; p=0·217). Planned moderator analysis showed that psychoeducation was most beneficial in participants with few (one to seven) previous bipolar episodes (χ2; HR 0·28, 95% CI 0·12-0·68; p=0·034). Four (1%) participants (one in the psychoeducation group and three in the peer-support group) died during follow-up; these deaths were deemed unrelated to the study interventions or procedures. INTERPRETATION: Structured group psychoeducation was no more clinically effective than similarly intensive unstructured peer support, but was more acceptable and improved outcome in participants with fewer previous bipolar episodes. Optimum provision of structured psychological interventions, such as group psychoeducation, early in the course of bipolar disorder might have important benefits on the course of illness, and merits further research. FUNDING: National Institute for Health Research.

Clinical characteristics associated with the prescribing of SSRI medication in adolescents with major unipolar depression.

Unipolar major depressions (MD) emerge markedly during adolescence. National Institute for Health and Care Excellence (NICE) UK recommends psychological therapies, with accompanying selective serotonin reuptake inhibitors (SSRIs) prescribed in severe cases only. Here, we seek to determine the extent and rationale of SSRI prescribing in adolescent MD before entering a randomised clinical trial. SSRI prescribing, together with their clinical characteristics was determined in 465 adolescent patients with MD prior to receiving a standardised psychological therapy as part of the Improving mood with psychoanalytic and cognitive therapies (IMPACT) clinical trial. Overall, 88 (19 %) had been prescribed antidepressants prior to psychological treatment. The clinical correlates varied by gender: respectively, depression severity in boys and self-harming behaviours in girls. Prescribing also differed between clinical research centres. Medical practitioners consider severity of depression in boys as an indicator for antidepressant prescribing. Self-injury in girls appears to be utilised as a prescribing aid which is inconsistent with past and current revised UK NICE guidelines.

Younger women's experiences of deciding against delayed breast reconstruction post-mastectomy following breast cancer: An interpretative phenomenological analysis.

Most women do not reconstruct their breast(s) post-mastectomy. The experiences of younger women who maintain this decision, although important to understand, are largely absent in the research literature. This interview-based study uses interpretative phenomenological analysis to explore the experiences of six women, diagnosed with primary breast cancer in their 30s/40s, who decided against delayed reconstruction. Findings reported here focus on one superordinate theme (decision-making) from a larger analysis, illustrating that the women's drive to survive clearly influenced their initial decision-making process. Their tenacity in maintaining their decision is highlighted, despite non-reconstruction sometimes being presented negatively by medical teams. Patient-centred support recommendations are made.

Study protocol for the randomised controlled trial: Ketamine augmentation of ECT to improve outcomes in depression (Ketamine-ECT study).

BACKGROUND: There is a robust empirical evidence base supporting the acute efficacy of electroconvulsive therapy (ECT) for severe and treatment resistant depression. However, a major limitation, probably contributing to its declining use, is that ECT is associated with impairment in cognition, notably in anterograde and retrograde memory and executive function. Preclinical and preliminary human data suggests that ketamine, used either as the sole anaesthetic agent or in addition to other anaesthetics, may reduce or prevent cognitive impairment following ECT. A putative hypothesis is that ketamine, through antagonising glutamate receptors, protects from excess excitatory neurotransmitter stimulation during ECT. The primary aim of the ketamine-ECT study is to investigate whether adjunctive ketamine can attenuate the cognitive impairment caused by ECT. Its secondary aim is to examine if ketamine increases the speed of clinical improvement with ECT. METHODS/DESIGN: The ketamine ECT study is a multi-site randomised, placebo-controlled, double blind trial. It was originally planned to recruit 160 moderately to severely depressed patients who had been clinically prescribed ECT. This recruitment target was subsequently revised to 100 patients due to recruitment difficulties. Patients will be randomly allocated on a 1:1 basis to receive either adjunctive ketamine or saline in addition to standard anaesthesia for ECT. The primary neuropsychological outcome measure is anterograde verbal memory (Hopkins Verbal Learning Test-Revised delayed recall task) after 4 ECT treatments. Secondary cognitive outcomes include verbal fluency, autobiographical memory, visuospatial memory and digit span. Efficacy is assessed using observer and self-report efficacy measures of depressive symptomatology. The effects of ECT and ketamine on cortical activity during cognitive tasks will be studied in a sub-sample using functional near-infrared spectroscopy (fNIRS). DISCUSSION: The ketamine-ECT study aims to establish whether or not adjunctive ketamine used together with standard anaesthesia for ECT will significantly reduce the adverse cognitive effects observed after ECT. Potential efficacy benefits of increased speed of symptom improvement and a reduction in the number of ECT treatments required will also be assessed, as will safety and tolerability of adjunctive ketamine. This study will provide important evidence as to whether adjunctive ketamine is routinely indicated for ECT given for depression in routine NHS clinical practice. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN14689382 (assigned 30/07/2012); EudraCT Number: 2011-005476-41.