When does NICE recommend the use of health technologies within a programme of evidence development?

This article is made available through the Brunel Open Access Publishing Fund. This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.This article has been made available through the Brunel Open Access Publishing Fund.Background: There is growing interest internationally in linking reimbursement decisions with recommendations for further research. In the UK, the National Institute for Health and Clinical Excellence (NICE) can issue guidance to approve the routine use of a health intervention, reject routine use or recommend use within a research programme. These latter recommendations have restricted use to ‘only in research’ (OIR) or have recommended further research alongside routine use (‘approval with research’ or AWR). However, it is not currently clear when such recommendations are likely to be made. Objectives: This study aims to identify NICE technology appraisals where OIR or AWR recommendations were made and to examine the key considerations that led to those decisions. Methods: Draft and final guidance including OIR/AWR recommendations were identified. The documents were reviewed to establish the characteristics of the technology appraisal, the cost effectiveness of the technologies, the key considerations that led to the recommendations and the types of research required. Results: In total, 29 final and 31 draft guidance documents included OIR/AWR recommendations up to January 2010. Overall, 86 % of final guidance included OIR recommendations. Of these, the majority were for technologies considered to be cost ineffective (83 %) and the majority of final guidance (66 %) specified the need for further evidence on relative effectiveness. The use of OIR/AWR recommendations is decreasing over time and they have rarely been used in appraisals conducted through the single technology appraisal process. Conclusion: NICE has used its ability to recommend technologies within research programmes, although predominantly within the multiple technology appraisal process. OIR recommendations have been most frequently issued for technologies considered cost ineffective and the most frequently cited consideration is uncertainty related to relative effectiveness. Key considerations cited for most AWR recommendations and some OIR recommendations included a need for further evidence on long-term outcomes and adverse effects of treatment.Medical Research Counci

Engagement and observation: a review of local policies in England and Wales

© 2020, Emerald Publishing Limited. Purpose: The purpose of this paper is to report on the content of local policies on engagement and observation written by National Health Service (NHS) organisations in England and Wales. Design/methodology/approach: Engagement and observation policies were obtained from all (n = 61) NHS mental health trusts in England and health boards in Wales via a Freedom of Information Act 2000 request. Data were analysed using content analysis. Findings: All organisations had a specific policy referring to either “observation and engagement” or “observation”. The policies varied considerably in quality, length, breadth and depth of the information provided. Significant variations existed in the terminology used to describe the different types of enhanced observation. Inconsistencies were also noted between organisations regarding: which members of the clinical team could initiate, increase, decrease and terminate observation; who could undertake the intervention (for example students); and the reasons for using it. Finally, despite rhetoric to the contrary, the emphasis of policies was on observation and not engagement. Research limitations/implications: This research has demonstrated the value of examining local policies for identifying inconsistencies in guidance given to practitioners on the implementation of engagement and observation. Further research should be undertaken to explore the impact of local policies on practice. Practical implications: Local policies remain variable in content and quality and do not reflect contemporary research. There is a need to produce evidence-based national standards that organisations are required to comply with. Originality/value: To the best of the author’s knowledge, this is the first research in 20 years examining the local policy framework for the implementation of engagement and observation

‘Golden age’ versus ‘bad old days’: A discursive examination of advice-giving in antenatal classes

Childbirth is seen as a medical event, and pregnancy, a time when parents-to-be are in need of advice. This article provides a discursive analysis of how such advice is given in antenatal classes. Using audio-recorded data from National Childbirth Trust (NCT)antenatal classes, we analyse how class leaders talk to class members about pregnancy, childbirth and infant care. We identify a pattern of advice giving in which class leaders construct ‘golden age’ or ‘bad old days’ stories variably to contrast the practices of the past (‘then’) with current practices (‘now’). These contrasting repertoires operate against a backdrop of medicalization and societal expectations that are both current and out-dated, providing a constitutive framework to support class leaders’ evaluations and advice on pregnancy, childbirth and infant care

Improving the psychological evaluation of exercise referral: psychometric properties of the Exercise Referral Quality of Life Scale

There is a growing need to assess the psychological outcomes of exercise referral and the National Institute of Health and Care Excellence has called for the routine assessment of life-quality. However, a quality of life scale specific to the requirements of exercise referral is currently unavailable. Therefore, the aim of this study was to produce a quality of life measure for this purpose. The Exercise Referral Quality of Life Scale is a 22-item measure comprising three domains: mental and physical health, injury pain and illness and physical activity facilitators. Exploratory factor analysis determined the initial factor structure and was subsequently confirmed by confirmatory factor analysis. Additional scale properties were also assessed. The scale contributes to the global need for improved consistent psychological outcome assessment of exercise referral

Is brief advice in primary care a cost-effective way to promote physical activity?

This article is made available through the Brunel Open Access Publishing Fund. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial.Aim: This study models the cost-effectiveness of brief advice (BA) in primary care for physical activity (PA) addressing the limitations in the current limited economic literature through the use of a time-based modelling approach. Methods: A Markov model was used to compare the lifetime costs and outcomes of a cohort of 100 000 people exposed to BA versus usual care. Health outcomes were expressed in terms of quality-adjusted life years (QALYs). Costs were assessed from a health provider perspective (£2010/11 prices). Data to populate the model were derived from systematic literature reviews and the literature searches of economic evaluations that were conducted for national guidelines. Deterministic and probability sensitivity analyses explored the uncertainty in parameter estimates including short-term mental health gains associated with PA. Results: Compared with usual care, BA is more expensive, incurring additional costs of £806 809 but it is more effective leading to 466 QALYs gained in the total cohort, a QALY gain of 0.0047/person. The incremental cost per QALY of BA is £1730 (including mental health gains) and thus can be considered cost-effective at a threshold of £20 000/QALY. Most changes in assumptions resulted in the incremental cost-effectiveness ratio (ICER) falling at or below £12 000/QALY gained. However, when short-term mental health gains were excluded the ICER was £27 000/QALY gained. The probabilistic sensitivity analysis showed that, at a threshold of £20 000/QALY, there was a 99.9% chance that BA would be cost-effective. Conclusions: BA is a cost-effective way to improve PA among adults, provided short-term mental health gains are considered. Further research is required to provide more accurate evidence on factors contributing to the cost-effectiveness of BA.NICE Centre for Public Health Excellenc

Out-of-school lives of physically disabled children and young people in the United Kingdom: A qualitative literature review

Currently there appears to be few opportunities and little evidence of physically disabled children and young people (C&YP) participating in mainstream social activities. A qualitative review was undertaken to examine the factors affecting physically disabled C&YP (8–15 years) in the United Kingdom participating in out-of-school activities. Views and experiences were explored from the perspective of the service users and providers to assess current provision and to determine the need for future research into factors that may affect participation. Searches were conducted across eight databases, the references of the included studies were checked and the websites were searched. Studies that used a qualitative design that examined the views relating to out-of-school activities were included. Nine papers were identified, which included three peer-reviewed papers and six pieces of grey literature and pertinent government documents to include views and experiences of out-of-school activity provision. The main themes emerging from the review were the need for social inclusion, out-of-school activities run by volunteers and accessibility, with threads throughout, which require further research including parental influence, provision, training and attitudes. This review highlights the absence of the service user’s voice and sheds light on the limited provision and barriers affecting participation in out-of-school activities

The cost of changing physical activity behaviour: Evidence from a "physical activity pathway" in the primary care setting

Copyright @ 2011 Boehler et al.BACKGROUND: The ‘Physical Activity Care Pathway’ (a Pilot for the ‘Let’s Get Moving’ policy) is a systematic approach to integrating physical activity promotion into the primary care setting. It combines several methods reported to support behavioural change, including brief interventions, motivational interviewing, goal setting, providing written resources, and follow-up support. This paper compares costs falling on the UK National Health Service (NHS) of implementing the care pathway using two different recruitment strategies and provides initial insights into the cost of changing physical activity behaviour. METHODS: A combination of a time driven variant of activity based costing, audit data through EMIS and a survey of practice managers provided patient-level cost data for 411 screened individuals. Self reported physical activity data of 70 people completing the care pathway at three month was compared with baseline using a regression based ‘difference in differences’ approach. Deterministic and probabilistic sensitivity analyses in combination with hypothesis testing were used to judge how robust findings are to key assumptions and to assess the uncertainty around estimates of the cost of changing physical activity behaviour. RESULTS: It cost £53 (SD 7.8) per patient completing the PACP in opportunistic centres and £191 (SD 39) at disease register sites. The completer rate was higher in disease register centres (27.3% vs. 16.2%) and the difference in differences in time spent on physical activity was 81.32 (SE 17.16) minutes/week in patients completing the PACP; so that the incremental cost of converting one sedentary adult to an ‘active state’ of 150 minutes of moderate intensity physical activity per week amounts to £ 886.50 in disease register practices, compared to opportunistic screening. CONCLUSIONS: Disease register screening is more costly than opportunistic patient recruitment. However, additional costs come with a higher completion rate and better outcomes in terms of behavioural change in patients completing the care pathway. Further research is needed to rigorously evaluate intervention efficiency and to assess the link between behavioural change and changes in quality adjusted life years (QALYs).This article is available through the Brunel Open Access Publishing Fund

Psychometric properties of the Behavioural Outcomes of Anxiety questionnaire in stroke patients with aphasia.

OBJECTIVE: To evaluate the psychometric properties of an observational, carer-completed anxiety screen for aphasic stroke patients. DESIGN: Phase 1: A cross-sectional questionnaire design to establish psychometric properties. Phase 2: A randomized longitudinal design with treatment and control to evaluate sensitivity to change and repeatability/reliability. SUBJECTS: Phase 1: 111 patient-carer dyads were recruited through stroke charities: patient mean age 69.7(10. 7), 6.2(5. 2) years since stroke, 76 male; carer mean age 64.7(12. 2), 27 male. Phase 2. A subsample of 50 dyads (29 completed). MEASURES: All patients completed the Tension Rating Circles and the Frenchay Aphasia Screening Test. Carers completed the Behavioural Outcomes of Anxiety questionnaire, observational versions of the Hospital Anxiety and Depression Scale (HADS-A) and the Generalised Anxiety Disorder-7, and a feedback questionnaire. INTERVENTION: Phase 2: 25 dyads were offered relaxation training and 25 acted as controls. RESULTS: The Behavioural Outcomes of Anxiety questionnaire correlated .77 with the HADS-A and Cronbach's Alpha was .82 demonstrating validity and internal consistency. Using HADS-A cut-off > 7 as criterion the area under the curve was 0.90 and at cut-off of > 16 sensitivity (0.85) and specificity (0.85) were both good. Scores declined significantly more in a group given anxiety training ( n = 12) than in a control group ( n = 17), demonstrating sensitivity to change and construct validity. Two-week repeatability/reliability was .92. Feedback suggested the scale was acceptable. CONCLUSIONS: The Behavioural Outcomes of Anxiety questionnaire shows promise as an anxiety screen for stroke patients with aphasia and is sensitive to change. Further analysis of dimensionality and discriminant validity is needed

Views about integrating smoking cessation treatment within psychological services for patients with common mental illness:A multi-perspective qualitative study

Background: Tobacco smoking rates are significantly higher in people with common mental illness compared to those without. Smoking cessation treatment could be offered as part of usual outpatient psychological care, but currently is not. Objective: To understand patient and health care professionals' views about integrating smoking cessation treatment into outpatient psychological services for common mental illness. Design: Qualitative in‐depth interviews, with thematic analysis. Participants: Eleven Improving Access to Psychological Therapies (IAPT) psychological wellbeing practitioners (PWPs), six IAPT patients, and six stop smoking advisors were recruited from English smoking cessation, and IAPT services. Results: Patients reported psychological benefits from smoking, and also described smoking as a form of self‐harm. Stop smoking advisors displayed therapeutic pessimism and stigmatizing attitudes towards helping people with mental illness to quit smoking. PWPs have positive attitudes towards smoking cessation treatment for people with common mental illness. PWPs and patients accept evidence that smoking tobacco may harm mental health, and quitting might benefit mental health. PWPs report expertise in helping people with common mental illness to make behavioural changes in the face of mood disturbances and low motivation. PWPs felt confident in offering smoking cessation treatments to patients, but suggested a caseload reduction may be required to deliver smoking cessation support in IAPT. Conclusions: IAPT appears to be a natural environment for smoking cessation treatment. PWPs may need additional training, and a caseload reduction. Integration of smoking cessation treatment into IAPT services should be tested in a pilot and feasibility study.</p

Bipolar at-risk criteria: an examination of which clinical features have optimal utility for identifying youth at risk of early transition from depression to bipolar disorders

Background: A clinical and research challenge is to identify which depressed youth are at risk of “early transition to bipolar disorders (ET-BD).” This 2-part study (1) examines the clinical utility of previously reported BD at-risk (BAR) criteria in differentiating ET-BD cases from unipolar depression (UP) controls; and (2) estimates the Number Needed to Screen (NNS) for research and general psychiatry settings. Methods: Fifty cases with reliably ascertained, ET-BD I  and II cases were matched for gender and birth year with 50 UP controls who did not develop BD over 2 years. We estimated the clinical utility for finding true cases and screening out non-cases for selected risk factors and their NNS. Using a convenience sample (N = 80), we estimated the NNS when adjustments were made to account for data missing from clinical case notes. Results: Sub-threshold mania, cyclothymia, family history of BD, atypical depression symptoms and probable antidepressant-emergent elation, occurred significantly more frequently in ET-BD youth. Each of these “BARDepression” criteria demonstrated clinical utility for screening out non-cases. Only cyclothymia demonstrated good utility for case finding in research settings; sub-threshold mania showed moderate utility. In the convenience sample, the NNS for each criterion ranged from ~4 to 7.  Conclusions: Cyclothymia showed the optimum profile for case finding, screening and NNS in research settings. However, its presence or absence was only reported in 50% of case notes. Future studies of ET-BD instruments should distinguish which criteria have clinical utility for case finding vs screening