Valuing qalys at the end of life

There have been changes in the way that NICE evaluates medical treatments for patients who are in the last stages of their lives. If medicines fulfil some criteria to be considered “end of life” NICE considers if QALYs gained under these circumstances should receive an extra weight. In this paper we provide evidence about the social support that this policy may have. We present the result of three surveys conducted in the Spanish general population (n=813). Survey 1 compared increases in life expectancy for patients at the end of their lives with health gains from temporary health problems. Survey 2 compared health gains for temporary health problems with health gains from end of life palliative care. Survey 3 compared increases in life expectancy with palliative care in both cases for end of life patients. Preferences were elicited with Person Trade-Off and Willingness to pay techniques. Our results suggest that QALYs for end of life treatments have a higher social value than for temporary health problems. However, we also find that people discriminate between different ways of health gains within End of Life treatment. People seem to attach a greater weight to palliative care than to life extension.QALY weights, end of life, palliative care, life extension

The ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation) trial – a pragmatic multicentre randomised controlled trial evaluating the clinical effectiveness and cost-effectiveness of surgical compared with non-surgical treatment for proximal fracture of the humerus in adults

Background Proximal humeral fractures account for 5–6% of all fractures in adults. There is considerable variation in whether or not surgery is used in the management of displaced fractures involving the surgical neck. Objective To evaluate the clinical effectiveness and cost-effectiveness of surgical compared with non-surgical treatment of the majority of displaced fractures of the proximal humerus involving the surgical neck in adults. Design A pragmatic parallel-group multicentre randomised controlled trial with an economic evaluation. Follow-up was for 2 years. Setting Recruitment was undertaken in the orthopaedic departments of 33 acute NHS hospitals in the UK. Patient care pathways included outpatient and community-based rehabilitation. Participants Adults (aged ≥ 16 years) presenting within 3 weeks of their injury with a displaced fracture of the proximal humerus involving the surgical neck. Interventions The choice of surgical intervention was left to the treating surgeons, who used techniques with which they were experienced. Non-surgical treatment was initial sling immobilisation followed by active rehabilitation. Provision of rehabilitation was comparable in both groups. Main outcome measures The primary outcome was the Oxford Shoulder Score (OSS) assessed at 6, 12 and 24 months. Secondary outcomes were the 12-item Short Form health survey, surgical and other shoulder fracture-related complications, secondary surgery to the shoulder or increased/new shoulder-related therapy, medical complications during inpatient stay and mortality. European Quality of Life-5 Dimensions data and treatment costs were also collected. Results The mean age of the 250 trial participants was 66 years and 192 (77%) were female. Independent assessment using the Neer classification identified 18 one-part fractures, 128 two-part fractures and 104 three- or four-part fractures. OSS data were available for 215 participants at 2 years. We found no statistically or clinically significant differences in OSS scores between the two treatment groups (scale 0–48, with a higher score indicating a better outcome) over the 2-year period [difference of 0.75 points in favour of the surgery group, 95% confidence interval (CI) –1.33 to 2.84; p  = 0.479; data from 114 surgery and 117 non-surgery participants] or at individual time points. We found no statistically significant differences between surgical and non-surgical group participants in SF-12 physical or mental component summary scores; surgical or shoulder fracture-related complications (30 vs. 23 respectively); those undergoing further shoulder-related therapy, either surgery (11 vs. 11 respectively) or other therapy (seven vs. four respectively); or mortality (nine vs. five respectively). The base-case economic analysis showed that, at 2 years, the cost of surgical intervention was, on average, £1780.73 more per patient (95% CI £1152.71 to £2408.75) than the cost of non-surgical intervention. It was also slightly less beneficial in terms of utilities, although this difference was not statistically significant. The net monetary benefit associated with surgery is negative. There was only a 5% probability of surgery achieving the criterion of costing < £20,000 to gain a quality-adjusted life-year, which was confirmed by extensive sensitivity analyses. Conclusions Current surgical practice does not result in a better outcome for most patients with displaced fracture

Enhancing Gypsy, Roma and Traveller peoples’ trust:using maternity and early years’ health services and dental health services as exemplars of mainstream service provision

Gypsies, Roma and Travellers (GRT) are socially excluded groups where evidence for improving health is weakest. Although GRT communities are diverse, and robust evidence of health needs is lacking, there is consensus that GRT in the UK have poorer health and lower life expectancy than the general population and other disadvantaged groups. Reasons why GRT are vulnerable to poor health outcomes include poor living conditions, high rates of homelessness, low educational achievement, social exclusion, widespread prejudice and discrimination and barriers to accessing healthcare. These multiple factors, alongside poor quality care that does not meet needs, may lead to low expectations and mistrust of health services. Trust in services and personnel is associated with increased utilisation of healthcare, improved health behaviours and quality of care. Community engagement strategies have the potential to enhance trust and ensure services are tailored to the needs of specific populations. This multi-component study aimed to strengthen evidence on how to improve uptake and delivery of health services and thereby reduce health inequalities for GRT

The impact of surgeon and patient treatment preferences in an orthopaedic trauma surgery trial

El presente estudio de investigación se ejecutó para identificar el liderazgo empresarial desde la perspectiva de los colaboradores en la agencia de viajes CTM Tours del distrito de Miraflores, 2017. La información recogida a los encuestados se llevó a cabo en el mismo distrito perteneciente al periodo 2017 – I, la metodología empleada fue, de nivel descriptiva con diseño no experimental y de corte transversal, el instrumento para la recolección de datos fue el cuestionario que consto de 24 reactivos y la técnica utilizada fue la encuesta que se aplicó a 40 colaboradores de la agencia de viajes, así mismo se determinó la confiabilidad del instrumento a través del alfa de Cronbach con 0.931. Examinado los resultados que arrojó el programa estadístico, se determinó que el liderazgo empresarial en base a los 4 criterios expuestos en el estudio, consideran que se da un liderazgo consultivo en el proceso decisorio; en el sistema de comunicación y en las relaciones interpersonales, sin embargo un 53% concuerda que en cuanto al sistemas de recompensas el rango predominante es el autoritario benevolente. Finalmente, se llegó a la conclusión que desde la perspectiva de los colaboradores de la agencia CTM Tours prevalece un liderazgo consultivo en un 60%. Todos estos factores unidos favorecen el desarrollo del crecimiento personal y profesional, llevado de la mano con buena relación entre líder y los superiores

The impact of pre and perinatal lifestyle factors on child long term health and social outcomes : a systematic review

To understand the full extent of the impact of a trial, it is important to consider the long-term consequences of outcomes beyond the trial follow-up period, especially for early year's interventions. A systematic review of the literature associated with the long-term consequences of four key outcomes from the Building Blocks trial, specifically, low birth weight, smoking during pregnancy, interval to subsequent pregnancy and A&E attendance or inpatient admission was conducted. These factors were guided by the funders, the Department of Health, as being of particular interest in the UK context. Relevant studies were identified from a number of sources including large databases, reference checking and citation searching. The search yielded 3665 papers, 43 of which were considered appropriate for inclusion. Of these, 29 were relating to smoking during pregnancy, 13 to low birth weight, 0 to A&E attendances during early childhood and 1 to short (< 2 years) interval to subsequent pregnancy. Consistent associations were found between maternal smoking during pregnancy and the effects this has on children's health, educational attainment and likelihood of engaging in problem behaviour and criminal activity in later life. Low birth weight was also found to impact on children's long-term health and cognitive development. Subsequent pregnancies within two years of the previous birth were linked with increased likelihood of pre-term birth and neonatal death. Only minimal evidence was identified regarding the consequences of a short interval to second pregnancy and of child A&E and outpatient attendances. Given that these outcomes have been identified by the UK Department of Health as of particular interest for UK benefit, investment of research in these areas is recommended to establish a clearer picture of both short and long-term consequences

Evaluating ‘Enhancing Pragmatic Language skills for Young children with Social communication impairments’ (E-PLAYS): a feasibility cluster-randomised controlled trial

Background This article reports the results from a feasibility study of an intervention (‘E-PLAYS’) aimed at supporting children who experience difficulties with social communication. E-PLAYS is based around a dyadic computer game, which aims to develop collaborative and communication skills. A pilot study found that when E-PLAYS was delivered by researchers, improvements on communication test scores and on collaborative behaviours were observed. The aim of this study was to ascertain the feasibility of running a full-scale trial to test the effectiveness of E-PLAYS in a National Health Service (NHS) setting with delivery by speech and language therapists and teaching assistants. Methods The study was a two-arm feasibility cluster-randomised controlled trial of the E-PLAYS intervention with a treatment as usual control arm. Data relating to recruitment and retention, treatment fidelity, acceptability to participants, suitability of outcomes and feasibility of collecting health economic measures and of determining cost-effectiveness were collected. Speech and language therapists selected suitable children (ages 4–7 years old) from their caseload. E-PLAYS intervention (experimental group) was then delivered by teaching assistants overseen by speech and language therapists. The control group received usual care. Assessments included blinded language measures and observations, non-blinded teacher-reported measures of peer relations and classroom behaviour and non-blinded parent-reported use of health and education resources and quality of life. Results Planned recruitment was for 70 children, in the event, 50 children were recruited which was sufficient for feasibility purposes. E-PLAYS was very highly rated by children, teaching assistants and speech and language therapists and treatment fidelity did not pose any issues. We were able to collect health economic data which suggests that E-PLAYS would be a low-cost intervention. Conclusion Based on recruitment, retention and adherence rates and our outcome measures, a full-scale randomised controlled trial estimated appears feasible and warranted to assess the effectiveness of E-PLAYS for use by the NHS and schools. Trial registration ISRCTN 14818949 (retrospectively registered)

Effectiveness of a nurse-led intensive home-visitation programme for first-time teenage mothers (Building Blocks):a pragmatic randomised controlled trial

SummaryBackgroundMany countries now offer support to teenage mothers to help them to achieve long-term socioeconomic stability and to give a successful start to their children. The Family Nurse Partnership (FNP) is a licensed intensive home-visiting intervention developed in the USA and introduced into practice in England that involves up to 64 structured home visits from early pregnancy until the child's second birthday by specially recruited and trained family nurses. We aimed to assess the effectiveness of giving the programme to teenage first-time mothers on infant and maternal outcomes up to 24 months after birth.MethodsWe did a pragmatic, non-blinded, randomised controlled, parallel-group trial in community midwifery settings at 18 partnerships between local authorities and primary and secondary care organisations in England. Eligible participants were nulliparous and aged 19 years or younger, and were recruited at less than 25 weeks' gestation. Field-based researchers randomly allocated mothers (1:1) via remote randomisation (telephone and web) to FNP plus usual care (publicly funded health and social care) or to usual care alone. Allocation was stratified by site and minimised by gestation (<16 weeks vs ≥16 weeks), smoking status (yes vs no), and preferred language of data collection (English vs non-English). Mothers and assessors (local researchers at baseline and 24 months' follow-up) were not masked to group allocation, but telephone interviewers were blinded. Primary endpoints were biomarker-calibrated self-reported tobacco use by the mother at late pregnancy, birthweight of the baby, the proportion of women with a second pregnancy within 24 months post-partum, and emergency attendances and hospital admissions for the child within 24 months post-partum. Analyses were by intention to treat. This trial is registered with ISRCTN, number ISRCTN23019866.FindingsBetween June 16, 2009, and July 28, 2010, we screened 3251 women. After enrolment, 823 women were randomly assigned to receive FNP and 822 to usual care. All follow-up data were retrieved by April 25, 2014. 304 (56%) of 547 women assigned to FNP and 306 (56%) of 545 assigned to usual care smoked at late pregnancy (adjusted odds ratio [AOR] 0·90, 97·5% CI 0·64–1·28). Mean birthweight of 742 babies with mothers assigned to FNP was 3217·4 g (SD 618·0), whereas birthweight of 768 babies assigned to usual care was 3197·5 g (SD 581·5; adjusted mean difference 20·75 g, 97·5% CI −47·73 to 89·23. 587 (81%) of 725 assessed children with mothers assigned to FNP and 577 (77%) of 753 assessed children assigned to usual care attended an emergency department or were admitted to hospital at least once before their second birthday (AOR 1·32, 97·5% CI 0·99–1·76). 426 (66%) of 643 assessed women assigned to FNP and 427 (66%) 646 assigned to usual care had a second pregnancy within 2 years (AOR 1·01, 0·77–1·33). At least one serious adverse event (mainly clinical events associated with pregnancy and infancy period) was reported for 310 (38%) of 808 participants (mother–child) in the usual care group and 357 (44%) of 810 in the FNP group, none of which were considered related to the intervention.InterpretationAdding FNP to the usually provided health and social care provided no additional short-term benefit to our primary outcomes. Programme continuation is not justified on the basis of available evidence, but could be reconsidered should supportive longer-term evidence emerge.FundingDepartment of Health Policy Research Programme

An intervention to reassure patients about test results in rapid access chest pain clinic: a pilot randomised controlled trial

BACKGROUND: Most people referred to rapid access chest pain clinics have non-cardiac chest pain, and in those diagnosed with stable coronary heart disease, guidance recommends that first-line treatment is usually medication rather than revascularisation. Consequently, many patients are not reassured they have the correct diagnosis or treatment. A previous trial reported that, in people with non-cardiac chest pain, a brief discussion with a health psychologist before the tests about the meaning of potential results led to people being significantly more reassured. The aim of this pilot was to test study procedures and inform sample size for a future multi-centre trial and to gain initial estimates of effectiveness of the discussion intervention. METHODS: This was a two-arm pilot randomised controlled trial in outpatient rapid access chest pain clinic in 120 people undergoing investigation for new onset, non-urgent chest pain. Eligible participants were randomised to receive either: a discussion about the meaning and implication of test results, delivered by a nurse before tests in clinic, plus a pre-test pamphlet covering the same information (Discussion arm) or the pre-test pamphlet alone (Pamphlet arm). Main outcome measures were recruitment rate and feasibility for a future multi-centre trial, with an estimate of reassurance in the groups at month 1 and 6 using a 5-item patient-reported scale. RESULTS: Two hundred and seventy people attended rapid access chest pain clinic during recruitment and 120/270 participants (44%) were randomised, 60 to each arm. There was no evidence of a difference between the Discussion and Pamphlet arms in the mean reassurance score at month 1 (34.2 vs 33.7) or at month 6 (35.3 vs 35.9). Patient-reported chest pain and use of heart medications were also similar between the two arms. CONCLUSIONS: A larger trial of the discussion intervention in the UK would not be warranted. Patients reported high levels of reassurance which were similar in patients receiving the discussion with a nurse and in those receiving a pamphlet alone. TRIAL REGISTRATION: Current Controlled Trials ISRCTN60618114 (assigned 27.05.2011). ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/1471-2261-14-138) contains supplementary material, which is available to authorized users