'Would I risk it again?' The long-term impacts of a traumatic birth, as experienced by fathers.

BACKGROUND: Extensive research has explored the impact of traumatic births on mothers, capturing enduring adverse outcomes as well as post-traumatic growth. The literature on fathers' experiences of birth trauma is more limited and little is known of the ongoing impact. The present study aimed to investigate the long-term effects of attending a traumatic birth. METHOD: Semi-structured interviews were completed with fathers who identified as having a traumatic birth experience two or more years ago. Thematic analysis was conducted on eight interview transcripts. RESULTS: Despite the time since the birth trauma, fathers described ongoing impact, which is captured in five themes. Four of these focus on the negative impacts: their attempts to cope by boxing away emotions, which they thought they should not feel; anxieties over having further children; negative effects on parenting; and ongoing distress or negative impact on their wellbeing. The final theme highlighted some positives from the experience, primarily a strengthened relationship with their partner. CONCLUSIONS: Traumatic birth can result in fathers experiencing difficulties beyond the perinatal period, whilst thinking that they should not feel or discuss their distress. As a result of a traumatic birth fathers can experience ongoing guilt and poor mental health, which may lead them to delay subsequent pregnancies. Most participants had not accessed support regarding the traumatic birth, instead coping by trying to avoid their memories and emotional reaction. These findings highlight the need for increased acknowledgement of the impact of birth trauma and intervention for fathers, during and after the perinatal period.

'A more human approach I haven't found that really': experiences of hoarding difficulties and seeking help.

BACKGROUND AND AIMS: People with hoarding behaviours often struggle to engage in treatment. This study aimed to explore the experiences of a sample of people who identify as engaging in hoarding behaviours and who are seeking support. Exploring motivation to seek help, the barriers those who hoard face in accessing support and what facilitates accepting help, can aid understanding of how best to intervene. METHOD: Eight individuals who self-identified as seeking help in relation to hoarding behaviours were recruited via social media and support groups. Interviews were conducted by telephone or video call, before being transcribed and analysed using interpretative phenomenological analysis. RESULTS: Participants described complex help-seeking narratives and reported continued ambivalence about addressing their hoarding behaviours. The four group experiential themes identified were Wrestling with identity; Who can I trust?; Services don't fit; and Being overlooked: 'they're too busy looking at the thing, not the person'. Difficulties trusting others and services were identified; services were experienced as rejecting and many participants sought help for problems other than their hoarding. Problems accessing appropriate help for hoarding were predominant in the narratives, although participants who had accessed peer support described this as valuable. CONCLUSIONS: There are both internal (e.g. fear of judgement; feeling overwhelmed) and external (e.g. service gaps) barriers that make finding useful help for hoarding behaviours very difficult. Services may facilitate those seeking help by taking a compassionate and person-centred approach to hoarding problems.

Health equity for persons with disabilities: a global scoping review on barriers and interventions in healthcare services.

BACKGROUND: Persons with disabilities experience health inequities in terms of increased mortality, morbidity, and limitations in functioning when compared to the rest of the population. Many of the poor health outcomes experienced by persons with disabilities cannot be explained by the underlying health condition or impairment, but are health inequities driven by unfair societal and health system factors. A synthesis of the global evidence is needed to identify the factors that hinder equitable access to healthcare services for persons with disabilities, and the interventions to remove these barriers and promote disability inclusion. METHODS: We conducted a scoping review following the methodological framework proposed by Arksey and O'Malley, Int J Soc Res Methodol 8:19-32. We searched two scholarly databases, namely MEDLINE (Ovid) and Web of Science, the websites of Organizations of Persons with Disabilities and governments, and reviewed evidence shared during WHO-led consultations on the topic of health equity for persons with disabilities. We included articles published after 2011 with no restriction to geographical location, the type of underlying impairments or healthcare services. A charting form was developed and used to extract the relevant information for each included article. RESULTS: Of 11,884 articles identified in the search, we included 182 articles in this review. The majority of sources originated from high-income countries. Barriers were identified worldwide across different levels of the health system (such as healthcare costs, untrained healthcare workforces, issues of inclusive and coordinated services delivery), and through wider contributing factors of health inequities that expand beyond the health system (such as societal stigma or health literacy). However, the interventions to promote equitable access to healthcare services for persons with disabilities were not readily mapped onto those needs, their sources of funding and projected sustainability were often unclear, and few offered targeted approaches to address issues faced by marginalized groups of persons with disabilities with intersectional identities. CONCLUSION: Persons with disabilities continue to face considerable barriers when accessing healthcare services, which negatively affects their chances of achieving their highest attainable standard of health. It is encouraging to note the increasing evidence on interventions targeting equitable access to healthcare services, but they remain too few and sparce to meet the populations' needs. Profound systemic changes and action-oriented strategies are warranted to promote health equity for persons with disabilities, and advance global health priorities.

Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups and a call to action.

BACKGROUND: Informed consent is considered a fundamental requirement for participation in trials, yet obtaining consent is challenging in a number of populations and settings. This may be due to participants having communication or other disabilities, their capacity to consent fluctuates or they lack capacity, or in emergency situations where their medical condition or the urgent nature of the treatment precludes seeking consent from either the participant or a representative. These challenges, and the subsequent complexity of designing and conducting trials where alternative consent pathways are required, contribute to these populations being underserved in research. Recognising and addressing these challenges is essential to support trials involving these populations and ensure that they have an equitable opportunity to participate in, and benefit from, research. Given the complex nature of these challenges, which are encountered by both adults and children, a cross-disciplinary approach is required. DISCUSSION: A UK-wide collaboration, a sub-group of the Trial Conduct Working Group in the MRC-NIHR Trial Methodology Research Partnership, was formed to collectively address these challenges. Members are drawn from disciplines including bioethics, qualitative research, trials methodology, healthcare professions, and social sciences. This commentary draws on our collective expertise to identify key populations where particular methodological and ethical challenges around consent are encountered, articulate the specific issues arising in each population, summarise ongoing and completed research, and identify targets for future research. Key populations include people with communication or other disabilities, people whose capacity to consent fluctuates, adults who lack the capacity to consent, and adults and children in emergency and urgent care settings. Work is ongoing by the sub-group to create a database of resources, to update NIHR guidance, and to develop proposals to address identified research gaps. CONCLUSION: Collaboration across disciplines, sectors, organisations, and countries is essential if the ethical and methodological challenges surrounding trials involving complex and alternate consent pathways are to be addressed. Explicating these challenges, sharing resources, and identifying gaps for future research is an essential first step. We hope that doing so will serve as a call to action for others seeking ways to address the current consent-based exclusion of underserved populations from trials.

Trial Forge Guidance 3: randomised trials and how to recruit and retain individuals from ethnic minority groups-practical guidance to support better practice.

Randomised trials, especially those intended to directly inform clinical practice and policy, should be designed to reflect all those who could benefit from the intervention under test should it prove effective. This does not always happen. The UK National Institute for Health and Care Research (NIHR) INCLUDE project identified many groups in the UK that are under-served by trials, including ethnic minorities.This guidance document presents four key recommendations for designing and running trials that include the ethnic groups needed by the trial. These are (1) ensure eligibility criteria and recruitment pathway do not limit participation in ways you do not intend, (2) ensure your trial materials are developed with inclusion in mind, (3) ensure staff are culturally competent and (4) build trusting partnerships with community organisations that work with ethnic minority groups. Each recommendation comes with best practice advice, public contributor testimonials, examples of the inclusion problem tackled by the recommendation, or strategies to mitigate the problem, as well as a collection of resources to support implementation of the recommendations.We encourage trial teams to follow the recommendations and, where possible, evaluate the strategies they use to implement them. Finally, while our primary audience is those designing, running and reporting trials, we hope funders, grant reviewers and approvals agencies may also find our guidance useful.

Development of a supported self-management intervention for adults with type 2 diabetes and a learning disability.

BACKGROUND: Although supported self-management is a well-recognised part of chronic disease management, it has not been routinely used as part of healthcare for adults with a learning disability. We developed an intervention for adults with a mild or moderate learning disability and type 2 diabetes, building on the principles of supported self-management with reasonable adjustments made for the target population. METHODS: In five steps, we:Clarified the principles of supported self-management as reported in the published literatureIdentified the barriers to effective self-management of type 2 diabetes in adults with a learning disabilityReviewed existing materials that aim to support self-management of diabetes for people with a learning disabilitySynthesised the outputs from the first three phases and identified elements of supported self-management that were (a) most relevant to the needs of our target population and (b) most likely to be acceptable and useful to themImplemented and field tested the intervention. RESULTS: The final intervention had four standardised components: (1) establishing the participant's daily routines and lifestyle, (2) identifying supporters and their roles, (3) using this information to inform setting realistic goals and providing materials to the patient and supporter to help them be achieved and (4) monitoring progress against goals.Of 41 people randomised in a feasibility RCT, thirty five (85%) completed the intervention sessions, with over three quarters of all participants (78%) attending at least three sessions.Twenty-three out of 40 (58%) participants were deemed to be very engaged with the sessions and 12/40 (30%) with the materials; 30 (73%) participants had another person present with them during at least one of their sessions; 15/41 (37%) were reported to have a very engaged main supporter, and 18/41 (44%) had a different person who was not their main supporter but who was engaged in the intervention implementation. CONCLUSIONS: The intervention was feasible to deliver and, as judged by participation and engagement, acceptable to participants and those who supported them. TRIAL REGISTRATION: Current Controlled Trials ISRCTN41897033 (registered 21/01/2013).

Managing with Learning Disability and Diabetes: OK-Diabetes - a case-finding study and feasibility randomised controlled trial.

BACKGROUND: Obesity and type 2 diabetes are common in adults with a learning disability. It is not known if the principles of self-management can be applied in this population. OBJECTIVES: To develop and evaluate a case-finding method and undertake an observational study of adults with a learning disability and type 2 diabetes, to develop a standardised supported self-management (SSM) intervention and measure of adherence and to undertake a feasibility randomised controlled trial (RCT) of SSM versus treatment as usual (TAU). DESIGN: Observational study and an individually randomised feasibility RCT. SETTING: Three cities in West Yorkshire, UK. PARTICIPANTS: In the observational study: adults aged > 18 years with a mild or moderate learning disability, who have type 2 diabetes that is not being treated with insulin and who are living in the community. Participants had mental capacity to consent to research and to the intervention. In the RCT participants had glycated haemoglobin (HbA1c) levels of > 6.5% (48 mmol/mol), a body mass index (BMI) of > 25 kg/m2 or self-reported physical activity below national guideline levels. INTERVENTIONS: Standardised SSM. TAU supported by an easy-read booklet. MAIN OUTCOME MEASURES: (1) The number of eligible participants identified and sources of referral; (2) current living and support arrangements; (3) current health state, including level of HbA1c, BMI and waist circumference, blood pressure and lipids; (4) mood, preferences for change; (5) recruitment and retention in RCT; (6) implementation and adherence to the intervention; (7) completeness of data collection and values for candidate primary outcomes; and (8) qualitative data on participant experience of the research process and intervention. RESULTS: In the observational study we identified 147 eligible consenting participants. The mean age was 54.4 years. In total, 130 out of 147 (88%) named a key supporter, with 113 supporters (77%) being involved in diabetes management. The mean HbA1c level was 54.5 mmol/mol [standard deviation (SD) 14.8 mmol/mol; 7.1%, SD 1.4%]. The BMI of 65% of participants was > 30 kg/m2 and of 21% was > 40 kg/m2. Many participants reported low mood, dissatisfaction with lifestyle and diabetes management and an interest in change. Non-response rates were high (45/147, 31%) for medical data requested from the primary care team. In the RCT, 82 participants were randomised. The mean baseline HbA1c level was 56 mmol/mol (SD 16.5 mmol/mol; 7.3%, SD 1.5%) and the mean BMI was 34 kg/m2 (SD 7.6 kg/m2). All SSM sessions were completed by 35 out of 41 participants. The adherence measure was obtained in 37 out of 41 participants. The follow-up HbA1c level and BMI was obtained for 75 out of 82 (91%) and 77 out of 82 (94%) participants, respectively. Most participants reported a positive experience of the intervention. A low response rate and difficulty understanding the EuroQol-5 Dimensions were challenges in obtaining data for an economic analysis. LIMITATIONS: We recruited from only 60% of eligible general practices, and 90% of participants were on a general practice learning disability register, which meant that we did not recruit many participants from the wider population with milder learning disability. CONCLUSIONS: A definitive RCT is feasible and would need to recruit 194 participants per arm. The main barrier is the resource-intensive nature of recruitment. Future research is needed into the effectiveness of obesity treatments in this population, particularly estimating the longer-term outcomes that are important for health benefit. Research is also needed into improving ways of assessing quality of life in adults with a learning disability. TRIAL REGISTRATION: Current Controlled Trials ISRCTN41897033. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 26. See the NIHR Journals Library website for further project information.

Developing and feasibility testing of data collection methods for an economic evaluation of a supported selfmanagement programme for adults with a learning disability and type 2 diabetes.

BACKGROUND: The challenges of conducting research with hard to reach vulnerable groups are particularly pertinent for people with learning disabilities. Data collection methods for previous cost and cost-effectiveness analyses of health and social care interventions targeting people with learning disabilities have relied on health care/health insurance records or data collection forms completed by the service provider rather than by people with learning disabilities themselves. This paper reports on the development and testing of data collection methods for an economic evaluation within a randomised controlled trial (RCT) for a supported self-management programme for people with mild/moderate learning disabilities and type 2 diabetes. METHODS: A case finding study was conducted to identify types of health and social care use and data collection methods employed in previous studies with this population. Based on this evidence, resource use questionnaires for completion by GP staff and interviewer-administered participant questionnaires (covering a wider cost perspective and health-related quality of life) were tested within a feasibility RCT. Interviewer-administered questionnaires included the EQ-5D-3L (the NICE recommended measure for use in economic evaluation). Participants were adults > 18 years with a mild or moderate learning disability and type 2 diabetes, with mental capacity to give consent to research participation. RESULTS: Data collection for questionnaires completed by GP staff requesting data for the last 12 months proved time intensive and difficult. Whilst 82.3% (121/147) of questionnaires were returned, up to 17% of service use items were recorded as unknown. Subsequently, a shorter recall period (4 months) led to a higher return rate but with a higher rate of missing data. Missing data for interviewer-administered participant questionnaires was > 8% but the interviewers reported difficulty with participant recall. Almost 60% (48/80) of participants had difficulty completing the EQ-5D-3L. CONCLUSIONS: Further investigation as to how service use can be recorded is recommended. Concerns about the reliability of identifying service use data directly from participants with a learning disability due to challenges in completion, specifically around recall, remain. The degree of difficulty to complete EQ-5D-3L indicates concerns regarding the appropriateness of using this measure in its current form in research with this population. TRIAL REGISTRATION: Current Controlled Trials ISRCTN41897033 (registered 21 January 2013).

Identifying people with a learning disability: an advanced search for general practice.

BACKGROUND: People with learning disabilities (LD) have poor physical and mental health when compared with the general population. They are also likely to find it more difficult than others to describe their symptoms adequately. It is therefore harder for healthcare workers to identify the health needs of those with learning disabilities, with the danger of some problems being left unrecognised. Practice registers record only a proportion of those who are eligible, making it difficult to target improvements in their health care. AIM: To test a Read Code search supporting the identification of people with a mild-to-moderate learning disability who are not currently on the learning disability register. DESIGN AND SETTING: An observational study in primary care in West Yorkshire. METHOD: Read Code searches were created to identify individuals with a learning disability not on the LD register; they were field tested and further refined before testing in general practice. RESULTS: Diagnostic codes identified small numbers of individuals who should have been on the LD register. Functional and service use codes often created large numbers of false-positive results. The specific descriptive codes 'Learning difficulties' and 'Referral to learning disability team' needed follow-up review, and then identified some individuals with LD who were not on the register. CONCLUSION: The Read Code search supported practices to populate their registers and was quick to run and review, making it a viable choice to support register revalidation. However, it did not find large numbers of people eligible for the LD register who were previously unidentified by their practice, suggesting that additional complementary methods are required to support practices to validate their registers.

Measurement of adherence in a randomised controlled trial of a complex intervention: supported self-management for adults with learning disability and type 2 diabetes.

BACKGROUND: Reporting adherence to intervention delivery and uptake is a detailed way of describing what was actually delivered and received, in comparison to what was intended. Measuring and reporting adherence is not routinely done well in complex interventions. The OK Diabetes trial (ISRCTN41897033) aimed to develop and subsequently test the feasibility of implementing a supported self-management intervention in adults with a learning disability and type 2 diabetes. A key study objective was to develop a measure of adherence to the intervention. METHODS: We conducted a systematic review of published literature, extracting data from included papers using a standardised proforma. We undertook a narrative synthesis of papers to determine the form and content of methods for adherence measurement for self-management interventions in this population that had already been developed. We used the framework and data extraction form developed for the review as the basis for an adherence measurement tool that we applied in the OK Diabetes trial. RESULTS: The literature review found variability in the quality and content of adherence measurement and reporting, with no standardised approach. We were able to develop an adherence measure based upon the review, and populate it with data collected during the OK Diabetes trial. The adherence tool proved satisfactory for recording and measuring adherence in the trial. CONCLUSION: There remains a need for a standardised approach to adherence measurement in the field of complex interventions. We have shown that it is possible to produce a simple, feasible measure for assessing adherence in the OK Diabetes trial.

Supported self-management for adults with type 2 diabetes and a learning disability (OK-Diabetes): study protocol for a randomised controlled feasibility trial.

BACKGROUND: Individuals with a learning disability (LD) are at higher risk of developing type 2 diabetes, but LD is not straightforward to define or identify, especially at the milder end of the spectrum, which makes case finding difficult. While supported self-management of health problems is now established, current material is largely educational and didactic with little that facilitates behavioural change. The interaction between the person with diabetes and others supporting their care is also largely unknown. For these reasons, there is considerable work needed to prepare for a definitive trial. The aim of this paper is to publish the abridged protocol of this preparatory work. METHODS/DESIGN: Phase I is a prospective case-finding study (target n = 120 to 350) to identify and characterise potential participants, while developing a standardised supported self-management intervention. Phase II is a randomised feasibility trial (target n = 80) with blinded outcome assessment. Patients identified in Phase I will be interviewed and consented prior to being randomised to (1) standard treatment, or (2) supported self-management. Both arms will also be provided with an 'easy read' accessible information resource on managing type 2 diabetes. The intervention will be standardised but delivered flexibly depending on patient need, including components for the participant, a supporter, and shared activities. Outcomes will be (i) robust estimates of eligibility, consent and recruitment rates with refined recruitment procedures; (ii) characterisation of the eligible population; (iii) a standardised intervention with associated written materials, (iv) adherence and negative outcomes measures; (v) preliminary estimates of adherence, acceptability, follow-up and missing data rates, along with refined procedures; and (vi) description of standard treatment. DISCUSSION: Our study will provide important information on the nature of type 2 diabetes in adults with LD living in the community, on the challenges of identifying those with milder LD, and on the possibilities of evaluating a standardised intervention to improve self-management in this population. TRIAL REGISTRATION: Current Controlled Trials ISRCTN41897033 (registered 21 January 2013).

The effects of financial incentives for case finding for depression in patients with diabetes and coronary heart disease: interrupted time series analysis.

OBJECTIVE: To evaluate the effects of Quality and Outcomes Framework (QOF) incentivised case finding for depression on diagnosis and treatment in targeted and non-targeted long-term conditions. DESIGN: Interrupted time series analysis. SETTING: General practices in Leeds, UK. PARTICIPANTS: 65 (58%) of 112 general practices shared data on 37,229 patients with diabetes and coronary heart disease targeted by case finding incentives, and 101,008 patients with four other long-term conditions not targeted (hypertension, epilepsy, chronic obstructive pulmonary disease and asthma). INTERVENTION: Incentivised case finding for depression using two standard screening questions. MAIN OUTCOME MEASURES: Clinical codes indicating new depression-related diagnoses and new prescriptions of antidepressants. We extracted routinely recorded data from February 2002 through April 2012. The number of new diagnoses and prescriptions for those on registers was modelled with a binomial regression, which provided the strength of associations between time periods and their rates. RESULTS: New diagnoses of depression increased from 21 to 94/100,000 per month in targeted patients between the periods 2002-2004 and 2007-2011 (OR 2.09; 1.92 to 2.27). The rate increased from 27 to 77/100,000 per month in non-targeted patients (OR 1.53; 1.46 to 1.62). The slopes in prescribing for both groups flattened to zero immediately after QOF was introduced but before incentivised case finding (p<0.01 for both). Antidepressant prescribing in targeted patients returned to the pre-QOF secular upward trend (Wald test for equivalence of slope, z=0.73, p=0.47); the slope was less steep for non-targeted patients (z=-4.14, p<0.01). CONCLUSIONS: Incentivised case finding increased new depression-related diagnoses. The establishment of QOF disrupted rising trends in new prescriptions of antidepressants, which resumed following the introduction of incentivised case finding. Prescribing trends are of concern given that they may include people with mild-to-moderate depression unlikely to respond to such treatment.

Incentivised case finding for depression in patients with chronic heart disease and diabetes in primary care: an ethnographic study.

OBJECTIVE: To examine the process of case finding for depression in people with diabetes and coronary heart disease within the context of a pay-for-performance scheme. DESIGN: Ethnographic study drawing on observations of practice routines and consultations, debriefing interviews with staff and patients and review of patient records. SETTING: General practices in Leeds, UK. PARTICIPANTS: 12 purposively sampled practices with a total of 119 staff; 63 consultation observations and 57 patient interviews. MAIN OUTCOME MEASURE: Audio recorded consultations and interviews with patients and healthcare professionals along with observation field notes were thematically analysed. We assessed outcomes of case finding from patient records. RESULTS: Case finding exacerbated the discordance between patient and professional agendas, the latter already dominated by the tightly structured and time-limited nature of chronic illness reviews. Professional beliefs and abilities affected how case finding was undertaken; there was uncertainty about how to ask the questions, particularly among nursing staff. Professionals were often wary of opening an emotional 'can of worms'. Subsequently, patient responses potentially suggesting emotional problems could be prematurely shut down by professionals. Patients did not understand why they were asked questions about depression. This sometimes led to defensive or even defiant answers to case finding. Follow-up of patients highlighted inconsistent systems and lines of communication for dealing with positive results on case finding. CONCLUSIONS: Case finding does not fit naturally within consultations; both professional and patient reactions somewhat subverted the process recommended by national guidance. Quality improvement strategies will need to take account of our results in two ways. First, despite their apparent simplicity, the case finding questions are not consultation-friendly and acceptable alternative ways to raise the issue of depression need to be supported. Second, case finding needs to operate within structured pathways which can be accommodated within available systems and resources.