A systematic review of economic analyses of psychological interventions and therapies in health-related settings

Additional file 1

Use of methods for specifying the target difference in randomised controlled trial sample size calculations : Two surveys of trialists' practice

© The Author(s), 2014.Peer reviewedPublisher PD

Family physicians’ and trainees’ experiences regarding cancer screening with patients with intellectual disability: an interpretive description study

People with intellectual disability receive breast, cervical, and colorectal cancer screening at lower rates relative to the general population, although the reasons for this disparity are largely unknown. Research, both with the general population and specific to people with intellectual disability, has revealed that a family physician’s recommendation for cancer screening or continuity of primary care may increase screening rates. We interviewed family physicians and family medicine trainees regarding their experiences recommending cancer screening to patients with intellectual disability. We concluded that the decision to recommend cancer screening is complex, and includes physicians weighing their clinical judgement as to the best provision of care for patients with a patient’s eligibility for screening, while continuing to respect patients’ autonomy. This patient-physician interaction occurs within the larger medical environment. Further research with experienced family physicians is warranted to better understand this complex phenomenon

Baseline characteristics of people experiencing homelessness with a recent drug overdose in the PHOENIx pilot randomised controlled trial

Background: Drug-related deaths in Scotland are the highest in Europe. Half of all deaths in people experiencing homelessness are drug related, yet we know little about the unmet health needs of people experiencing homelessness with recent non-fatal overdose, limiting a tailored practice and policy response to a public health crisis. Methods: People experiencing homelessness with at least one non-fatal street drug overdose in the previous 6 months were recruited from 20 venues in Glasgow, Scotland, and randomised into PHOENIx plus usual care, or usual care. PHOENIx is a collaborative assertive outreach intervention by independent prescriber NHS Pharmacists and third sector homelessness workers, offering repeated integrated, holistic physical, mental and addictions health and social care support including prescribing. We describe comprehensive baseline characteristics of randomised participants. Results: One hundred and twenty-eight participants had a mean age of 42 years (SD 8.4); 71% male, homelessness for a median of 24 years (IQR 12–30). One hundred and eighteen (92%) lived in large, congregate city centre temporary accommodation. A quarter (25%) were not registered with a General Practitioner. Participants had overdosed a mean of 3.2 (SD 3.2) times in the preceding 6 months, using a median of 3 (IQR 2–4) non-prescription drugs concurrently: 112 (87.5%) street valium (benzodiazepine-type new psychoactive substances); 77 (60%) heroin; and 76 (59%) cocaine. Half (50%) were injecting, 50% into their groins. 90% were receiving care from Alcohol and Drug Recovery Services (ADRS), and in addition to using street drugs, 90% received opioid substitution therapy (OST), 10% diazepam for street valium use and one participant received heroin-assisted treatment. Participants had a mean of 2.2 (SD 1.3) mental health problems and 5.4 (SD 2.5) physical health problems; 50% received treatment for physical or mental health problems. Ninety-one per cent had at least one mental health problem; 66% had no specialist mental health support. Participants were frail (70%) or pre-frail (28%), with maximal levels of psychological distress, 44% received one or no daily meal, and 58% had previously attempted suicide. Conclusions: People at high risk of drug-related death continue to overdose repeatedly despite receiving OST. High levels of frailty, multimorbidity, unsuitable accommodation and unmet mental and physical health care needs require a reorientation of services informed by evidence of effectiveness and cost-effectiveness. Trial registration UK Clinical Trials Registry identifier: ISRCTN 10585019

Pharmaceutical regulation in 15 European countries: review

In the context of pharmaceutical care, policy-makers repeatedly face the challenge of balancing patient access to effective medicines with affordability and rising costs. With the aim of guiding the health policy discourse towards questions that are important to actual and potential patients, this study investigates a broad range of regulatory measures, spanning marketing authorization to generic substitution and resulting price levels in a sample of 16 European health systems (Austria, Belgium, Denmark, England, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Poland, Portugal, Scotland, Spain and Sweden). All countries employ a mix of regulatory mechanisms to contain pharmaceutical expenditure and ensure quality and efficiency in pharmaceutical care, albeit with varying configurations and rigour. This variation also influences the extent of publicly financed pharmaceutical costs. Overall, observed differences in pharmaceutical expenditure should be interpreted in conjunction with the differing volume and composition of consumption and price levels, as well as dispensation practices and their impact on measurement of pharmaceutical costs. No definitive evidence has yet been produced on the effects of different cost-containment measures on patient outcomes. Depending on the foremost policy concerns in each country, different levers will have to be used to enable the delivery of appropriate care at affordable prices

Facilitating the transition of young people with long-term conditions through health services from childhood to adulthood: the Transition research programme

Background: As young people with long-term conditions move from childhood to adulthood, their health may deteriorate and their social participation may reduce. ‘Transition’ is the ‘process’ that addresses the medical, psychosocial and educational needs of young people during this time. ‘Transfer’ is the ‘event’ when medical care moves from children’s to adults’ services. In a typical NHS Trust serving a population of 270,000, approximately 100 young people with long-term conditions requiring secondary care reach the age of 16 years each year. As transition extends over about 7 years, the number in transition at any time is approximately 700. Objectives: Purpose – to promote the health and well-being of young people with long-term conditions by generating evidence to enable NHS commissioners and providers to facilitate successful health-care transition. Objectives – (1) to work with young people to determine what is important in their transitional health care, (2) to identify the effective and efficient features of transitional health care and (3) to determine how transitional health care should be commissioned and provided. Design, settings and participants: Three work packages addressed each objective. Objective 1. (i) A young people’s advisory group met monthly throughout the programme. (ii) It explored the usefulness of patient-held health information. (iii) A ‘Q-sort’ study examined how young people approached transitional health care. Objective 2. (i) We followed, for 3 years, 374 young people with type 1 diabetes mellitus (150 from five sites in England), autism spectrum disorder (118 from four sites in England) or cerebral palsy (106 from 18 sites in England and Northern Ireland). We assessed whether or not nine proposed beneficial features (PBFs) of transitional health care predicted better outcomes. (ii) We interviewed a subset of 13 young people about their transition. (iii) We undertook a discrete choice experiment and examined the efficiency of illustrative models of transition. Objective 3. (i) We interviewed staff and observed meetings in three trusts to identify the facilitators of and barriers to introducing developmentally appropriate health care (DAH). We developed a toolkit to assist the introduction of DAH. (ii) We undertook a literature review, interviews and site visits to identify the facilitators of and barriers to commissioning transitional health care. (iii) We synthesised learning on ‘what’ and ‘how’ to commission, drawing on meetings with commissioners. Main outcome measures: Participation in life situations, mental well-being, satisfaction with services and condition-specific outcomes. Strengths: This was a longitudinal study with a large sample; the conditions chosen were representative; non-participation and attrition appeared unlikely to introduce bias; the research on commissioning was novel; and a young person’s group was involved. Limitations: There is uncertainty about whether or not the regions and trusts in the longitudinal study were representative; however, we recruited from 27 trusts widely spread over England and Northern Ireland, which varied greatly in the number and variety of the PBFs they offered. The quality of delivery of each PBF was not assessed. Owing to the nature of the data, only exploratory rather than strict economic modelling was undertaken. Results and conclusions: (1) Commissioners and providers regarded transition as the responsibility of children’s services. This is inappropriate, given that transition extends to approximately the age of 24 years. Our findings indicate an important role for commissioners of adults’ services to commission transitional health care, in addition to commissioners of children’s services with whom responsibility for transitional health care currently lies. (2) DAH is a crucial aspect of transitional health care. Our findings indicate the importance of health services being commissioned to ensure that providers deliver DAH across all health-care services, and that this will be facilitated by commitment from senior provider and commissioner leaders. (3) Good practice led by enthusiasts rarely generalised to other specialties or to adults’ services. This indicates the importance of NHS Trusts adopting a trust-wide approach to implementation of transitional health care. (4) Adults’ and children’s services were often not joined up. This indicates the importance of adults’ clinicians, children’s clinicians and general practitioners planning transition procedures together. (5) Young people adopted one of four broad interaction styles during transition: ‘laid back’, ‘anxious’, ‘wanting autonomy’ or ‘socially oriented’. Identifying a young person’s style would help personalise communication with them. (6) Three PBFs of transitional health care were significantly associated with better outcomes: ‘parental involvement, suiting parent and young person’, ‘promotion of a young person’s confidence in managing their health’ and ‘meeting the adult team before transfer’. (7) Maximal service uptake would be achieved by services encouraging appropriate parental involvement with young people to make decisions about their care. A service involving ‘appropriate parental involvement’ and ‘promotion of confidence in managing one’s health’ may offer good value for money. Future work: How might the programme’s findings be implemented by commissioners and health-care providers? What are the most effective ways for primary health care to assist transition and support young people after transfer

Holistic health and social care outreach for people experiencing homelessness with recent non-fatal overdose in Glasgow, Scotland: the Pharmacist and third sector Homeless charity worker Outreach Engagement Non-medical Independent prescriber Rx (PHOENIx) pilot randomised controlled trial

Objectives: To examine randomised controlled trial (RCT) progression criteria including emergency department (ED) attendance and non-fatal overdose, from a holistic, integrated health and social care outreach intervention (PHOENIx), for people experiencing homelessness with recent non-fatal street drug overdose. Design: Pilot RCT. 1:1 randomisation to PHOENIx plus usual care (UC) or UC. Setting: Glasgow, Scotland. Participants: 128 adults experiencing homelessness with at least one non-fatal street drug overdose in the preceding 6 months. Interventions: Pharmacists from the National Health Service and third sector homelessness workers offered weekly outreach. PHOENIx teams develop therapeutic relationships to address health (physical health, mental health and problem drug use) and social care (housing, welfare benefits and social prescribing) in addition to UC. UC comprised building-based primary and secondary health, social and third sector services. Outcomes: Primary: progression criteria: recruitment (≥100 participants in 4 months); ≥80% of participants with data collected at baseline, 6 and 9 months; ≥60% of participants retained in the trial at each follow-up period (6 and 9 months); ≥60% of participants receiving the intervention weekly; any reduction in the rate of presentation to ED and overdoses, at 6- or 9-month follow-up. Secondary: participants with, and time to: hospitalisations; health-related quality of life (QoL); treatment uptake for physical and mental health conditions, and problematic drug use. Results: Progression criteria were exceeded. In PHOENIx compared with UC, there appeared to be a delay in the median time to ED visit, overdose and hospitalisation but no improvement in number of participants with ED visits, overdoses or hospitalisations. QoL and treatment uptake appeared to be higher in PHOENIx versus UC at 6 and 9 months. Conclusions: A definitive RCT is merited, to assess the impact of PHOENIx on people with multiple, severe disadvantages

Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial.

BACKGROUND: Loss of arm function is a common and distressing consequence of stroke. We describe the protocol for a pragmatic, multicentre randomised controlled trial to determine whether robot-assisted training improves upper limb function following stroke. METHODS/DESIGN: Study design: a pragmatic, three-arm, multicentre randomised controlled trial, economic analysis and process evaluation. SETTING: NHS stroke services. PARTICIPANTS: adults with acute or chronic first-ever stroke (1 week to 5 years post stroke) causing moderate to severe upper limb functional limitation. Randomisation groups: 1. Robot-assisted training using the InMotion robotic gym system for 45 min, three times/week for 12 weeks 2. Enhanced upper limb therapy for 45 min, three times/week for 12 weeks 3. Usual NHS care in accordance with local clinical practice Randomisation: individual participant randomisation stratified by centre, time since stroke, and severity of upper limb impairment. PRIMARY OUTCOME: upper limb function measured by the Action Research Arm Test (ARAT) at 3 months post randomisation. SECONDARY OUTCOMES: upper limb impairment (Fugl-Meyer Test), activities of daily living (Barthel ADL Index), quality of life (Stroke Impact Scale, EQ-5D-5L), resource use, cost per quality-adjusted life year and adverse events, at 3 and 6 months. Blinding: outcomes are undertaken by blinded assessors. Economic analysis: micro-costing and economic evaluation of interventions compared to usual NHS care. A within-trial analysis, with an economic model will be used to extrapolate longer-term costs and outcomes. Process evaluation: semi-structured interviews with participants and professionals to seek their views and experiences of the rehabilitation that they have received or provided, and factors affecting the implementation of the trial. SAMPLE SIZE: allowing for 10% attrition, 720 participants provide 80% power to detect a 15% difference in successful outcome between each of the treatment pairs. Successful outcome definition: baseline ARAT 0-7 must improve by 3 or more points; baseline ARAT 8-13 improve by 4 or more points; baseline ARAT 14-19 improve by 5 or more points; baseline ARAT 20-39 improve by 6 or more points. DISCUSSION: The results from this trial will determine whether robot-assisted training improves upper limb function post stroke. TRIAL REGISTRATION: ISRCTN, identifier: ISRCTN69371850 . Registered 4 October 2013

Patient and public involvement (PPI) in UK surgical trials: a survey and focus groups with stakeholders to identify practices, views, and experiences

Background and aims Historically, patient and public involvement (PPI) in the design and conduct of surgical trials has been absent or minimal, but it is now routinely recommended and even required by some research funders. We aimed to identify and describe current PPI practice in surgical trials in the United Kingdom, and to explore the views and experiences of surgical trial staff and patient or public contributors in relation to these practices. This was part of a larger study to inform development of a robust PPI intervention aimed at improving recruitment and retention in surgical trials. Methods Our study had two stages: 1) an online survey to identify current PPI practice in active UK-led, adult surgical trials; and 2) focus groups and interviews with key stakeholders (surgical trial investigators, administrators, and patient or public contributors) to explore their views and experiences of PPI. Results Of 129 eligible surgical trial teams identified, 71 (55%) took part in the survey. In addition, 54 stakeholders subsequently took part in focus groups or interviews. Sixty-five (92%) survey respondents reported some kind of PPI, most commonly at the design and dissemination stages and in oversight or advisory roles. The single most common PPI activity was developing participant information sheets (72%). Participants reported mixed practice and views on a variety of issues including the involvement of patients versus lay members of the public, recruitment methods, use of role descriptions and payment for the time of PPI contributors. They suggested some solutions, including the use of written role descriptions and databases of potential PPI contributors to aid recruitment. Conclusions UK surgical trials involve patients and members of the public in a variety of different ways, most commonly at the beginning and end of the trial lifecycle and in oversight or advisory roles. These are not without challenges and there remain uncertainties about who best to involve, why, and how. Future research should aim to address these issues