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Background: Women who have experienced domestic violence and abuse (DVA) are at increased risk of developing post-traumatic stress disorder (PTSD) and complex PTSD (CPTSD). In 2014-15, we developed a prototype trauma-specific mindfulness-based cognitive therapy curriculum (TS-MBCT) for the treatment of PTSD in a DVA population. This study aimed to refine the prototype TS-MBCT and evaluate the feasibility of conducting a randomised controlled trial (RCT) testing its effectiveness and cost-effectiveness. Methods: Intervention refinement phase was informed by evidence synthesis from a literature review, qualitative interviews with professionals and DVA survivors, and a consensus exercise with experts in trauma and mindfulness. We tested the refined TS-MBCT intervention in an individually randomised parallel group feasibility trial with pre-specified progression criteria, a traffic light system, and embedded process and health economics evaluations. Results: The TS-MBCT intervention consisted of eight group sessions and home practice. We screened 109 women in a DVA agency and recruited 20 (15 TS-MBCT, 5 self-referral to National Health Service (NHS) psychological treatment), with 80% follow-up at 6 months. Our TS-MBCT intervention had 73% uptake, 100% retention, and high acceptability. Participants suggested recruitment via multiple agencies, and additional safety measures. Randomisation into the NHS control arm did not work due to long waiting lists and previous negative experiences. Three self-administered PTSD/CPTSD questionnaires produced differing outcomes thus a clinician administered measure might work better. We met six out of nine feasibility progression criteria at green and three at amber targets demonstrating that it is possible to conduct a full-size RCT of the TS-MBCT intervention after making minor amendments to recruitment and randomisation procedures, the control intervention, primary outcomes measures, and intervention content. At 6 months, none of the PTSD/CPTSD outcomes ruled out a clinically important difference between trial arms indicating that it is reasonable to proceed to a full-size RCT to estimate these outcomes with greater precision. Conclusions: A future RCT of the coMforT TS-MBCT intervention should recruit from multiple DVA agencies, NHS and non-NHS settings, have an active control psychological treatment, use robust randomisation and safety procedures, and clinician-administered measures for PTSD/CPTSD. Trial registration: ISRCTN64458065 11/01/2019, https://www.isrctn.com/ISRCTN64458065?q=64458065&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10

Background Up to one in eight women experience depression during pregnancy. In the UK, low intensity cognitive behavioural therapy (CBT) is the main psychological treatment offered for those with mild or moderate depression and is recommended during the perinatal period, however referral by midwives and take up of treatment by pregnant women is extremely low. Interpersonal Counselling (IPC) is a brief, low-intensity form of Interpersonal Psychotherapy (IPT) that focuses on areas of concern to service users during pregnancy. To improve psychological treatment for depression during pregnancy, the study aimed to assess the feasibility and acceptability of a trial of IPC for antenatal depression in routine NHS services compared to low intensity perinatal specific CBT. Methods We conducted a small randomised controlled trial in two centres. A total of 52 pregnant women with mild or moderate depression were randomised to receive 6 sessions of IPC or perinatal specific CBT. Treatment was provided by 12 junior mental health workers (jMHW). The primary outcome was the number of women recruited to the point of randomisation. Secondary outcomes included maternal mood, couple functioning, attachment, functioning, treatment adherence, and participant and staff acceptability. Results The study was feasible and acceptable. Recruitment was successful through scanning clinics, only 6 of the 52 women were recruited through midwives. 71% of women in IPC completed treatment. Women reported IPC was acceptable, and supervisors reported high treatment competence in IPC arm by jMHWs. Outcome measures indicated there was improvement in mood in both groups (Change in EPDS score IPC 4.4 (s.d. 5.1) and CBT 4.0 (s.d. 4.8). Conclusions This was a feasibility study and was not large enough to detect important differences between IPC and perinatal specific CBT. A full-scale trial of IPC for antenatal depression in routine IAPT services is feasible. Trial registration This study has been registered with ISRCTN registry 11513120. – date of registration 05/04/2018.

Background Up to one in eight women experience depression during pregnancy. In the UK, low intensity cognitive behavioural therapy (CBT) is the main psychological treatment offered for those with mild or moderate antenatal depression, but has limited relevance to the perinatal context. Referral by midwives and take up of treatment by pregnant women is extremely low. Interpersonal Counselling (IPC) is a brief, low-intensity form of Interpersonal Psychotherapy (IPT) that focuses on areas of concern to service users during pregnancy.To improve psychological treatment for depression during pregnancy, the study aimed to assess the feasibility and acceptability of a trial of IPC for antenatal depression in routine NHS services compared to low intensity perinatal specific CBT.Methods. We conducted a small randomised controlled trial in two centres. A total of 52 pregnant women with mild or moderate depression were randomised to receive 6 sessions of IPC or perinatal specific CBT. Treatment was provided by 12 junior mental health workers (jMHW). The primary outcome was the number of women recruited to the point of randomisation. Secondary outcomes included maternal mood, couple functioning, attachment, functioning, treatment adherence, and participant and staff acceptability. Results. The study was feasible and acceptable. Recruitment was successful through scanning clinics, only 6 of the 52 women were recruited through midwives. Treatment competence by jMHWs was high. 71% of women in IPC completed treatment. Women reported IPC was acceptable, and supervisors reported high treatment fidelity in IPC therapists. Outcome measures indicated there was improvement in mood in both groups (Change in EPDS score IPC 4.4 (s.d. 5.1) and CBT 4.0 (s.d. 4.8).Conclusions. This was a feasibility study and was not large enough to detect important differences between IPC and perinatal specific CBT. A full-scale trial of IPC for antenatal depression in routine IAPT services is feasible.Trial registrationThis study has been registered with ISRCTN registry 11513120. – date of registration 05/04/2018. https://doi.org/10.1186/ISRCTN11513120

IntroductionLateral compression type 1 (LC1) pelvic fractures are the most common type of pelvic fracture. The majority of LC1 fractures are considered stable. Fractures where a complete sacral fracture is present increases the degree of potential instability and have the potential to displace over time. Non-operative management of these unstable fractures may involve restricted weight bearing and significant rehabilitation. Frequent monitoring with X-rays is also necessary for displacement of the fracture. Operative stabilisation of these fractures may be appropriate to prevent displacement of the fracture. This may allow patients to mobilise pain-free, quicker.Methods and analysisThe study is a feasibility study to inform the design of a full definitive randomised controlled trial to guide the most appropriate management of these injuries. Participants will be recruited from major trauma centres and randomly allocated to either operative or non-operative management of their injuries. A variety of outcome instruments, measuring health-related quality of life, functional outcome and pain, will be completed at several time points up to 12 months post injury. Qualitative interviews will be undertaken with participants to explore their views of the treatments under investigation and trial processes.Eligibility and recruitment to the study will be analysed to inform the feasibility of a definitive trial. Completion rates of the measurement instruments will be assessed, as well as their sensitivity to change and the presence of floor or ceiling effects in this population, to inform the choice of the primary outcome for a definitive trial.Ethics and disseminationEthical approval for the study was given by the South West—Central Bristol NHS Research Ethics Committee on 2nd July 2018 (Ref; 18/SW/0135). The study will be reported in relevant specialist journals and through presentation at specialist conferences.Trial registration numberISRCTN10649958

Summary: We studied the association between deprivation and healthcare costs after hip fracture. Hospital costs in the year following hip fracture were £1120 higher for those living in more deprived areas. Most of this difference was explained by preexisting health inequalities which should be targeted to reduce this disparity.Introduction: To quantify differences in hospital costs following hip fracture between those living in higher and lower deprivation areas of England, we investigate pre- and post-fracture variables that explain the association.Methods: We used English Hospital Episodes Statistics linked to the National Hip Fracture Database (April 2011–March 2015) and national mortality data to identify patients admitted with hip fracture aged 60+ years. Hospital care was costed using 2017/2018 national reference costs, by index of multiple deprivation quintile. Three generalised linear model regressions estimated associations between deprivation and costs and the pre- and post-fracture variables that mediate this relationship.Results: Patients from the most deprived areas had higher hospital costs in the year post-fracture (£1,120; 95% CI £993 to £1,247) than those from the least deprived areas. If all patients could have incurred similar costs to those in the least deprived quintile, this would equate to an annual reduction in expenditure of £28.8 million. Pre-fracture characteristics, particularly comorbidities and anaesthetic risk grade, accounted for approximately 50% of the association between deprivation and costs. No evidence was found that post-fracture variables, such as transfer to a residential or nursing home, contributed to the association between deprivation and costs.Conclusions: Socioeconomic inequalities are associated with substantial costs for the NHS after hip fracture. We did not identify post-fracture targets for intervention to reduce the impact of inequalities on post-fracture costs. The case for interventions to reduce comorbid conditions, improve health-related behaviours and prevent falls in deprived areas is clear but challenging to implement.

IntroductionOne in eight women suffer from depression during pregnancy. Currently, low-intensity brief treatment based on cognitive behavioural therapy (CBT) is the only talking treatment widely available in the National Health Service (NHS) for mild and moderate depression. CBT involves identifying and changing unhelpful negative thoughts and behaviours to improve mood. Mothers in our patient advisory groups requested greater treatment choice. Interpersonal counselling (IPC) is a low-intensity version of interpersonal therapy. It may have important advantages during pregnancy over CBT because it targets relationship problems, changes in role and previous losses (eg, miscarriage). We aim to compare CBT and IPC for pregnant women with depression in a feasibility study.Methods and analysisA two-arm non-blinded randomised feasibility study of 60 women will be conducted in two UK localities. Women with depression will be identified through midwife clinics and ultrasound scanning appointments and randomised to receive six sessions of IPC or CBT. In every other way, these women will receive usual care. Women thought to have severe depression will be referred for more intensive treatment. After 12 weeks, we will measure women’s mood, well-being, relationship satisfaction and use of healthcare. Women, their partners and staff providing treatments will be interviewed to understand whether IPC is an acceptable approach and whether changes should be introduced before applying to run a larger trial.Several groups of patients with depression during pregnancy have contributed to our study design. A patient advisory group will meet and advise us during the study.Ethics and disseminationStudy results will inform the design of a larger multicentre randomised controlled trial (RCT). Our findings will be shared through public engagement events, papers and reports to organisations within the NHS. National Research Ethics Service Committee approved the study protocol.Trial registration numberISRCTN11513120.

Background Coeliac disease affects approximately 1% of the population and is increasingly diagnosed in the United Kingdom. A nationwide consultation in England has recommend that state-funded provisions for gluten-free (GF) food should be restricted to bread and mixes but not banned, yet financial strain has prompted regions of England to begin partially or fully ceasing access to these provisions. The impact of these policy changes on different stakeholders remains unclear. Methods Prescription data were collected for general practice services across England (n = 7176) to explore changes in National Health Service (NHS) expenditure on GF foods over time (2012–2017). The effects of sex, age, deprivation and rurality on GF product expenditure were estimated using a multi-level gamma regression model. Spending rate within NHS regions that had introduced a ‘complete ban’ or a ‘complete ban with age-related exceptions’ was compared to spending in the same time periods amongst NHS regions which continued to fund prescriptions for GF products. Results Annual expenditure on GF products in 2012 (before bans were introduced in any area) was £25.1 million. Higher levels of GF product expenditure were found in general practices in areas with lower levels of deprivation, higher levels of rurality and higher proportions of patients aged under 18 and over 75. Expenditure on GF food within localities that introduced a ‘complete ban’ or a ‘complete ban with age-related exceptions’ were reduced by approximately 80% within the 3 months following policy changes. If all regions had introduced a ‘complete ban’ policy in 2014, the NHS in England would have made an annual cost-saving of £21.1 million (equivalent to 0.24% of the total primary care medicines expenditure), assuming no negative sequelae. Conclusions The introduction of more restrictive GF prescribing policies has been associated with ‘quick wins’ for NHS regions under extreme financial pressure. However, these initial savings will be largely negated if GF product policies revert to recently published national recommendations. Better evidence of the long-term impact of restricting GF prescribing on patient health, expenses and use of NHS services is needed to inform policy. Electronic supplementary material The online version of this article (10.1186/s12916-018-1106-7) contains supplementary material, which is available to authorized users.