Recovery from recurrent depression with mindfulness-based cognitive therapy and antidepressants: a qualitative study with illustrative case studies

Objectives: This study aimed to describe the recovery journeys of people with a history of recurrent depression who took part in a psychosocial programme designed to teach skills to prevent depressive relapse (mindfulness-based cognitive therapy (MBCT)), alongside maintenance antidepressant medication (ADM). Design: A qualitative study embedded within a multicentre, single blind, randomised controlled trial (the PREVENT trial). Setting: Primary care urban and rural settings in the UK. Participants 42 people who participated in the MBCT arm of the parent trial were purposively sampled to represent a range of recovery journeys. Interventions: MBCT involves eight weekly group sessions, with four refresher sessions offered in the year following the end of the programme. It was adapted to offer bespoke support around ADM tapering and discontinuation. Methods: Written feedback and structured in-depth interviews were collected in the 2 years after participants undertook MBCT. Data were analysed using thematic analysis and case studies constructed to illustrate the findings. Results: People with recurrent depression have unique recovery journeys that shape and are shaped by their pharmacological and psychological treatment choices. Their journeys typically include several over-arching themes: (1) beliefs about the causes of depression, both biological and psychosocial; (2) personal agency, including expectations about their role in recovery and treatment; (3) acceptance, both of depression itself and the recovery journey; (4) quality of life; (5) experiences and perspectives on ADM and ADM tapering-discontinuation; and (6) the role of general practitioners, both positive and negative. Conclusions: People with recurrent depression describe unique, complex recovery journeys shaped by their experiences of depression, treatment and interactions with health professionals. Understanding how several themes coalesce for each individual can both support their recovery and treatment choices as well as health professionals in providing more accessible, collaborative, individualised and empowering care. :Trial registration number: Clinical trial number ISRCTN26666654; post results.</p

Quantification of breast density using dual-energy mammography with liquid phantom calibration

Breast density is a widely recognized potential risk factor for breast cancer. However, accurate quantification of breast density is a challenging task in mammography. The current use of plastic breast-equivalent phantoms for calibration provides limited accuracy in dual-energy mammography due to the chemical composition of the phantom. We implemented a breast-equivalent liquid phantom for dual-energy calibration in order to improve the accuracy of breast density measurement. To design these phantoms, three liquid compounds were chosen: water, isopropyl alcohol, and glycerol. Chemical compositions of glandular and adipose tissues, obtained from NIST database, were used as reference materials. Dual-energy signal of the liquid phantom at different breast densities (0% to 100%) and thicknesses (1 to 8 cm) were simulated. Glandular and adipose tissue thicknesses were estimated from a higher order polynomial of the signals. Our results indicated that the linear attenuation coefficients of the breast-equivalent liquid phantoms match those of the target material. Comparison between measured and known breast density data shows a linear correlation with a slope close to 1 and a non-zero intercept of 7%, while plastic phantoms showed a slope of 0.6 and a non-zero intercept of 8%. Breast density results derived from the liquid calibration phantoms showed higher accuracy than those derived from the plastic phantoms for different breast thicknesses and various tube voltages. We performed experimental phantom studies using liquid phantoms and then compared the computed breast density with those obtained using a bovine tissue model. The experimental data and the known values were in good correlation with a slope close to 1 (∼1.1). In conclusion, our results indicate that liquid phantoms are a reliable alternative for calibration in dual-energy mammography and better reproduce the chemical properties of the target material

Longitudinal evaluation of a countywide alternative to the Quality and Outcomes Framework in UK General Practice aimed at improving Person Centred Coordinated Care

Objectives To evaluate a county-wide deincentivisation of the Quality and Outcomes Framework (QOF) payment scheme for UK General Practice (GP). Setting In 2014, National Health Service England signalled a move towards devolution of QOF to Clinical Commissioning Groups. Fifty-five GPs in Somerset established the Somerset Practice Quality Scheme (SPQS)—a deincentivisation of QOF—with the goal of redirecting resources towards Person Centred Coordinated Care (P3C), especially for those with long-term conditions (LTCs). We evaluated the impact on processes and outcomes of care from April 2016 to March 2017. Participants and design The evaluation used data from 55 SPQS practices and 17 regional control practices for three survey instruments. We collected patient experiences (‘P3C-EQ’; 2363 returns from patients with 1+LTC; 36% response rate), staff experiences (‘P3C-practitioner’; 127 professionals) and organisational data (‘P3C-OCT’; 36 of 55 practices at two time points, 65% response rate; 17 control practices). Hospital Episode Statistics emergency admission data were analysed for 2014–2017 for ambulatory-sensitive conditions across Somerset using interrupted time series. Results Patient and practitioner experiences were similar in SPQS versus control practices. However, discretion from QOF incentives resulted in time savings in the majority of practices, and SPQS practice data showed a significant increase in P3C oriented organisational processes, with a moderate effect size (Wilcoxon signed rank test; p=0.01; r=0.42). Analysis of transformation plans and organisational data suggested stronger federation-level agreements and informal networks, increased multidisciplinary working, reallocation of resources for other healthcare professionals and changes to the structure and timings of GP appointments. No disbenefits were detected in admission data. Conclusion The SPQS scheme leveraged time savings and reduced administrative burden via discretionary removal of QOF incentives, enabling practices to engage actively in a number of schemes aimed at improving care for people with LTCs. We found no differences in the experiences of patients or healthcare professionals between SPQS and control practices.Objectives To evaluate a county-wide deincentivisation of the Quality and Outcomes Framework (QOF) payment scheme for UK General Practice (GP). Setting In 2014, National Health Service England signalled a move towards devolution of QOF to Clinical Commissioning Groups. Fifty-five GPs in Somerset established the Somerset Practice Quality Scheme (SPQS)—a deincentivisation of QOF—with the goal of redirecting resources towards Person Centred Coordinated Care (P3C), especially for those with long-term conditions (LTCs). We evaluated the impact on processes and outcomes of care from April 2016 to March 2017. Participants and design The evaluation used data from 55 SPQS practices and 17 regional control practices for three survey instruments. We collected patient experiences (‘P3C-EQ’; 2363 returns from patients with 1+LTC; 36% response rate), staff experiences (‘P3C-practitioner’; 127 professionals) and organisational data (‘P3C-OCT’; 36 of 55 practices at two time points, 65% response rate; 17 control practices). Hospital Episode Statistics emergency admission data were analysed for 2014–2017 for ambulatory-sensitive conditions across Somerset using interrupted time series. Results Patient and practitioner experiences were similar in SPQS versus control practices. However, discretion from QOF incentives resulted in time savings in the majority of practices, and SPQS practice data showed a significant increase in P3C oriented organisational processes, with a moderate effect size (Wilcoxon signed rank test; p=0.01; r=0.42). Analysis of transformation plans and organisational data suggested stronger federation-level agreements and informal networks, increased multidisciplinary working, reallocation of resources for other healthcare professionals and changes to the structure and timings of GP appointments. No disbenefits were detected in admission data. Conclusion The SPQS scheme leveraged time savings and reduced administrative burden via discretionary removal of QOF incentives, enabling practices to engage actively in a number of schemes aimed at improving care for people with LTCs. We found no differences in the experiences of patients or healthcare professionals between SPQS and control practices

The association of breast mitogens with mammographic densities

Radiologically dense breast tissue (mammographic density) is strongly associated with risk of breast cancer, but the biological basis for this association is unknown. In this study we have examined the association of circulating levels of hormones and growth factors with mammographic density. A total of 382 subjects, 193 premenopausal and 189 postmenopausal, without previous breast cancer or current hormone use, were selected in each of five categories of breast density from mammography units. Risk factor information, anthropometric measures, and blood samples were obtained, and oestradiol, progesterone, sex hormone binding globulin, growth hormone, insulin-like growth factor-I and its principal binding protein, and prolactin measured. Mammograms were digitised and measured using a computer-assisted method. After adjustment for other risk factors, we found in premenopausal women that serum insulin-like growth factor-I levels, and in postmenopausal women, serum levels of prolactin, were both significantly and positively associated with per cent density. Total oestradiol and progesterone levels were unrelated to per cent density in both groups. In postmenopausal women, free oestradiol (negatively), and sex hormone binding globulin (positively), were significantly related to per cent density. These data show an association between blood levels of breast mitogens and mammographic density, and suggest a biological basis for the associated risk of breast cancer

An exploratory randomised controlled trial of a premises-level intervention to reduce alcohol-related harm including violence in the United Kingdom

&lt;b&gt;Background&lt;/b&gt;&lt;p&gt;&lt;/p&gt; To assess the feasibility of a randomised controlled trial of a licensed premises intervention to reduce severe intoxication and disorder; to establish effect sizes and identify appropriate approaches to the development and maintenance of a rigorous research design and intervention implementation.&lt;p&gt;&lt;/p&gt; &lt;b&gt;Methods&lt;/b&gt;&lt;p&gt;&lt;/p&gt; An exploratory two-armed parallel randomised controlled trial with a nested process evaluation. An audit of risk factors and a tailored action plan for high risk premises, with three month follow up audit and feedback. Thirty-two premises that had experienced at least one assault in the year prior to the intervention were recruited, match paired and randomly allocated to control or intervention group. Police violence data and data from a street survey of study premises’ customers, including measures of breath alcohol concentration and surveyor rated customer intoxication, were used to assess effect sizes for a future definitive trial. A nested process evaluation explored implementation barriers and the fidelity of the intervention with key stakeholders and senior staff in intervention premises using semi-structured interviews.&lt;p&gt;&lt;/p&gt; &lt;b&gt;Results&lt;/b&gt;&lt;p&gt;&lt;/p&gt; The process evaluation indicated implementation barriers and low fidelity, with a reluctance to implement the intervention and to submit to a formal risk audit. Power calculations suggest the intervention effect on violence and subjective intoxication would be raised to significance with a study size of 517 premises.&lt;p&gt;&lt;/p&gt; &lt;b&gt;Conclusions&lt;/b&gt;&lt;p&gt;&lt;/p&gt; It is methodologically feasible to conduct randomised controlled trials where licensed premises are the unit of allocation. However, lack of enthusiasm in senior premises staff indicates the need for intervention enforcement, rather than voluntary agreements, and on-going strategies to promote sustainability

Interrogating intervention delivery and participants' emotional states to improve engagement and implementation: A realist informed multiple case study evaluation of Engager.

BACKGROUND: 'Engager' is an innovative 'through-the-gate' complex care intervention for male prison-leavers with common mental health problems. In parallel to the randomised-controlled trial of Engager (Trial registration number: ISRCTN11707331), a set of process evaluation analyses were undertaken. This paper reports on the depth multiple case study analysis part of the process evaluation, exploring how a sub-sample of prison-leavers engaged and responded to the intervention offer of one-to-one support during their re-integration into the community. METHODS: To understand intervention delivery and what response it elicited in individuals, we used a realist-informed qualitative multiple 'case' studies approach. We scrutinised how intervention component delivery lead to outcomes by examining underlying causal pathways or 'mechanisms' that promoted or hindered progress towards personal outcomes. 'Cases' (n = 24) were prison-leavers from the intervention arm of the trial. We collected practitioner activity logs and conducted semi-structured interviews with prison-leavers and Engager/other service practitioners. We mapped data for each case against the intervention logic model and then used Bhaskar's (2016) 'DREIC' analytic process to categorise cases according to extent of intervention delivery, outcomes evidenced, and contributing factors behind engagement or disengagement and progress achieved. RESULTS: There were variations in the dose and session focus of the intervention delivery, and how different participants responded. Participants sustaining long-term engagement and sustained change reached a state of 'crises but coping'. We found evidence that several components of the intervention were key to achieving this: trusting relationships, therapeutic work delivered well and over time; and an in-depth shared understanding of needs, concerns, and goals between the practitioner and participants. Those who disengaged were in one of the following states: 'Crises and chaos', 'Resigned acceptance', 'Honeymoon' or 'Wilful withdrawal'. CONCLUSIONS: We demonstrate that the 'implementability' of an intervention can be explained by examining the delivery of core intervention components in relation to the responses elicited in the participants. Core delivery mechanisms often had to be 'triggered' numerous times to produce sustained change. The improvements achieved, sustained, and valued by participants were not always reflected in the quantitative measures recorded in the RCT. The compatibility between the practitioner, participant and setting were continually at risk of being undermined by implementation failure as well as changing external circumstances and participants' own weaknesses. TRIAL REGISTRATION NUMBER: ISRCTN11707331, Wales Research Ethics Committee, Registered 02-04-2016-Retrospectively registered https://doi.org/10.1186/ISRCTN11707331

Evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release: study protocol for a randomised controlled trial.

INTRODUCTION: The 'Engager' programme is a 'through-the-gate' intervention designed to support prisoners with common mental health problems as they transition from prison back into the community. The trial will evaluate the clinical and cost-effectiveness of the Engager intervention. METHODS AND ANALYSIS: The study is a parallel two-group randomised controlled trial with 1:1 individual allocation to either: (a) the Engager intervention plus standard care (intervention group) or (b) standard care alone (control group) across two investigation centres (South West and North West of England). Two hundred and eighty prisoners meeting eligibility criteria will take part. Engager is a person-centred complex intervention delivered by practitioners and aimed at addressing offenders' mental health and social care needs. It comprises one-to-one support for participants prior to release from prison and for up to 20 weeks postrelease. The primary outcome is change in psychological distress measured by the Clinical Outcomes in Routine Evaluation-Outcome Measure at 6 months postrelease. Secondary outcomes include: assessment of subjective met/unmet need, drug and alcohol use, health-related quality of life and well-being-related quality of life measured at 3, 6 and 12 months postrelease; change in objective social domains, drug and alcohol dependence, service utilisation and perceived helpfulness of services and change in psychological constructs related to desistence at 6 and 12 months postrelease; and recidivism at 12 months postrelease. A process evaluation will assess fidelity of intervention delivery, test hypothesised mechanisms of action and look for unintended consequences. An economic evaluation will estimate the cost-effectiveness. ETHICS AND DISSEMINATION: This study has been approved by the Wales Research Ethics Committee 3 (ref: 15/WA/0314) and the National Offender Management Service (ref: 2015-283). Findings will be disseminated to commissioners, clinicians and service users via papers and presentations. TRIAL REGISTRATION NUMBER: ISRCTN11707331; Pre-results