Publications by authors named "Emma McIntosh"

74 Publications

Participant Experiences of a Quit Smoking Attempt Through Either Nicotine Replacement Therapy (NRT) Methods or the Use of an E-cigarette.

J Addict Med 2021 Jun 14. Epub 2021 Jun 14.

Academy for Sport and Physical Activity, Health and Wellbeing Department, Sheffield Hallam University, Sheffield, UK (GJ), Lifestyle Exercise and Nutrition Improvement (LENI) Research Group, Department of Nursing and Midwifery, College of Health, Wellbeing and Life Sciences, Sheffield Hallam University, Sheffield, UK (GJ, EM, MK), Addictions, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK and SPECTRUM Research Consortium, UK (LSB).

Objectives: There is a lack of evidence exploring experiences of using e-cigarettes for smoking cessation. The study's main aim was to explore participant experiences of e-cigarettes compared to nicotine replacement therapy (NRT) delivered through stop smoking services.

Methods: Semi-structured, face-to-face, and telephone interviews at 3-month post-quit follow-up in a randomized controlled trial comparing nicotine-containing e-cigarettes, nicotine-free e-cigarettes, and NRT for smoking cessation. N = 17 participants, 9 were male, mean age 44 years, 5 using nicotine-containing e-cigarettes, 7 nicotine-free e-cigarettes, and 5 NRT. Interviews were transcribed and analyzed using thematic analysis.

Results: Two global themes and 5 organizing themes were identified. Global themes included: (1) experiences of e-cigarette and NRT quit aids (e-cigarette positive impact and dilemmas, NRT perceptions and experiences), and (2) key mechanisms to support quit attempt (physical aids, advice and support, feedback and structure). E-cigarettes were viewed with caution, however, generally evaluated positively alongside NRT methods, finding e-cigarettes useful during a quit attempt due to their versatility in application. Nicotine-containing e-cigarettes were favored due to their support with nicotine cravings. Participants were, however, wary of replacing smoking addiction with vaping habit.

Conclusions: Participant e-cigarette experience were generally positive; however, concerns over long-term application were noted. There was a noticeable preference for nicotine-containing e-cigarettes, but further research is required to better understand how nicotine is used in conjunction with e-cigarettes long-term as a quit aid alongside other NRT.
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http://dx.doi.org/10.1097/ADM.0000000000000881DOI Listing
June 2021

Healthy eating and lifestyle in pregnancy (HELP): a cluster randomised trial to evaluate the effectiveness of a weight management intervention for pregnant women with obesity on weight at 12 months postpartum.

Int J Obes (Lond) 2021 May 21. Epub 2021 May 21.

Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.

Objective: To assess whether a weight management intervention for pregnant women with obesity was effective in reducing body mass index (BMI) 12 months after giving birth.

Methods: Pragmatic, cluster randomised controlled trial (RCT) with embedded cost-effectiveness analysis. 598 women with a BMI of ≥30 kg/m (between 12 and 20 weeks gestation) were recruited from 20 secondary care maternity units in England and Wales. BMI at 12 months postpartum was the primary outcome. A range of clinical and behavioural secondary outcomes were examined.

Interventions: Women attending maternity units randomised to intervention were invited to a weekly weight management group, which combined expertise from a commercial weight loss programme with clinical advice from midwives. Both intervention and control participants received usual care and leaflets on diet and physical activity in pregnancy.

Results: Mean (SD) BMI at 12 months postpartum was 36.0 kg/m (5.2) in the control group, and 37.5 kg/m (6.7) in the intervention group. After adjustment for baseline BMI, the intervention effect was -0.02 (95% CI -0.04 to 0.01). The intervention group had an improved healthy eating score (3.08, 95% CI 0.16 to 6.00, p < 0.04), improved fibre score (3.22, 1.07 to 5.37, p < 0.01) and lower levels of risky drinking at 12 months postpartum compared to the control group (OR 0.45, 0.27 to 0.74, p < 0.002). The net incremental monetary benefit was not statistically significantly different between arms, although the probability of the intervention being cost-effective was above 60%, at policy-relevant thresholds.

Conclusions: There was no significant difference between groups on the primary outcome of BMI at 12 months. Analyses of secondary outcomes indicated improved healthy eating and lower levels of risky drinking.

Trial Registration: Current Controlled Trials ISRCTN25260464.
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http://dx.doi.org/10.1038/s41366-021-00835-0DOI Listing
May 2021

Cost-Effectiveness of Dopamine Agonists and Monoamine Oxidase B Inhibitors in Early Parkinson's Disease.

Mov Disord 2021 May 7. Epub 2021 May 7.

University of Oxford, Oxford, United Kingdom.

Background: The PD MED study reported small but persistent benefits in patient-rated mobility scores and quality of life from initiating therapy with levodopa compared with levodopa-sparing therapies in early Parkinson's disease (PD).

Objectives: The objective was to estimate the cost-effectiveness of levodopa-sparing therapy (dopamine agonists or monoamine oxidase type B inhibitors compared with levodopa alone.

Methods: PD MED is a pragmatic, open-label randomized, controlled trial in which patients newly diagnosed with PD were randomly assigned between levodopa-sparing therapy (dopamine agonists or monoamine oxidase type B inhibitors ) and levodopa alone. Mean quality-adjusted life-years and costs were calculated for each participant. Differences in mean quality-adjusted life-years and costs between levodopa and levodopa-sparing therapies and between dopamine agonists and monoamine oxidase type B inhibitors were estimated using linear regression.

Results: Over a mean observation period of 4 years, levodopa was associated with significantly higher quality-adjusted life-years (difference, 0.18; 95% CI, 0.05-0.30; P < 0.01) and lower mean costs (£3390; £2671-£4109; P < 0.01) than levodopa-sparing therapies, the difference in costs driven by the higher costs of levodopa-sparing therapies. There were no significant differences in the costs of inpatient, social care, and institutional care between arms. There was no significant difference in quality-adjusted life-years between those allocated dopamine agonists and monoamine oxidase type B inhibitors (0.02; -0.17 to 0.13 in favor of dopamine agonists; P = 0.81); however costs were significantly lower for those allocated monoamine oxidase type B inhibitors (£2321; £1628-£3015; P < 0.01) because of the higher costs of dopamine agonists. There were no significant differences between arms for other costs.

Conclusions: Initial treatment with levodopa is highly cost-effective compared with levodopa-sparing therapies. Monoamine oxidase type B inhibitors, as initial levodopa-sparing therapy was more cost-effective, with similar quality-adjusted life-years but lower costs than dopamine agonists. © 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.
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http://dx.doi.org/10.1002/mds.28623DOI Listing
May 2021

Older Adults' Experiences of a Physical Activity and Sedentary Behaviour Intervention: A Nested Qualitative Study in the SITLESS Multi-Country Randomised Clinical Trial.

Int J Environ Res Public Health 2021 04 29;18(9). Epub 2021 Apr 29.

Fundació Salut i Envelliment (Foundation on Health and Ageing)-UAB, Universitat Autònoma de Barcelona, 08041 Barcelona, Spain.

Background: The SITLESS programme comprises exercise referral schemes and self-management strategies and has been evaluated in a trial in Denmark, Spain, Germany and Northern Ireland. The aim of this qualitative study was to understand the implementation and contextual aspects of the intervention in relation to the mechanisms of impact and to explore the perceived effects.

Methods: Qualitative methodologies were nested in the SITLESS trial including 71 individual interviews and 12 focus groups targeting intervention and control group participants from postintervention to 18-month follow-up in all intervention sites based on a semi-structured topic guide.

Results: Overarching themes were identified under the framework categories of context, implementation, mechanisms of impact and perceived effects. The findings highlight the perceived barriers and facilitators to older adults' engagement in exercise referral schemes. Social interaction and enjoyment through the group-based programmes are key components to promote adherence and encourage the maintenance of targeted behaviours through peer support and connectedness. Exit strategies and signposting to relevant classes and facilities enabled the maintenance of positive lifestyle behaviours.

Conclusions: When designing and implementing interventions, key components enhancing social interaction, enjoyment and continuity should be in place in order to successfully promote sustained behaviour change.
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http://dx.doi.org/10.3390/ijerph18094730DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8124427PMC
April 2021

Socially vs. Privately Optimal Control of Livestock Diseases: A Case for Integration of Epidemiology and Economics.

Front Vet Sci 2020 25;7:558409. Epub 2020 Nov 25.

College of Medical, Veterinary and Life Sciences, Institute of Biodiversity, Animal Health and Comparative Medicine, University of Glasgow, Glasgow, United Kingdom.

This paper aims to illustrate the interdependencies between key epidemiological and economic factors that influence the control of many livestock infectious diseases. The factors considered here are (i) farmer heterogeneity (i.e., differences in how farmers respond to a perceived disease risk), (ii) off-farm effects of farmers' actions to control a disease (i.e., costs and benefits borne by agents that are external to the farm), and (iii) misalignment between privately and socially optimal control efforts (i.e., privately optimal behavior not conducive to a socially optimal outcome). Endemic chronic diseases cause a wide range of adverse social and economic impacts, particularly in low-income countries. The actions taken by farmers to control livestock diseases minimize some of these impacts, and heterogeneity in those actions leads to variation in prevalence at the farm level. While some farmers respond to perceived disease risks, others free-ride on the actions of these individuals, thereby compromising the potential benefits of collective, coordinated behavior. When evaluating a plausible range of disease cost to price of control ratios and assuming that farmers choose their privately optimal control effort, we demonstrate that achievement of a socially optimal disease control target is unlikely, occurring in <25% of all price-cost combinations. To achieve a socially optimal disease control outcome (reliant on farmers' voluntary actions), control policies must consider farmer heterogeneity, off-farm effects, and the predicted uptake of control measures under the assumption of optimized behavior.
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http://dx.doi.org/10.3389/fvets.2020.558409DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7723844PMC
November 2020

An app-, web- and social support-based weight loss intervention for adults with obesity: the 'HelpMeDoIt!' feasibility randomised controlled trial.

Pilot Feasibility Stud 2020 19;6:133. Epub 2020 Sep 19.

MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Berkeley Square, 99 Berkeley Street, Glasgow, G3 7HR UK.

Background: Social support has an important role in successful weight loss. The aim of this study was to assess the feasibility and acceptability of an app-, web- and social support-based intervention in supporting adults with obesity to achieve weight loss.

Methods: The intervention and evaluation methods were tested in a feasibility randomised controlled trial. Adults in the Greater Glasgow and Clyde Health Board area of Scotland with a body mass index ≥ 30 kg/m were recruited and randomised 2:1 (intervention to control). The feasibility and acceptability of the intervention and trial methods were assessed against pre-specified progression criteria, via process, economic and outcome evaluation. Three primary outcomes were explored: BMI, diet and physical activity, as well as a number of secondary outcomes. The intervention group had access to the HelpMeDoIt! intervention for 12 months. This encouraged them to (i) set goals, (ii) monitor progress and (iii) harness social support by inviting 'helpers' from their existing social network. The control group received a healthy lifestyle leaflet.

Results: One hundred and nine participants were recruited, with 84 participants (77%) followed-up at 12 months. The intervention and trial methods were feasible and acceptable. Participants and helpers were generally positive. Of the 54 (74%) participants who downloaded the app, 48 (89%) used it. Interview data indicated that HelpMeDoIt! promoted social support from existing social networks to support weight loss. This support was often given outside of the app.Outcomes were compared using linear regression models, with randomised group, the baseline measurement of the outcome, age and gender as predictor variables. These analyses were exploratory and underpowered to detect effects. However, all pre-specified primary outcome effects (BMI, diet and physical activity) had wide confidence intervals and were therefore consistent with clinically relevant benefits. Objective physical activity measures perhaps showed most potential (daily step count ( = 0.098; 1187 steps [- 180, 2555])) and sedentary time ( = 0.022; - 60.8 min [- 110.5, - 11.0]). However, these outcomes were poorly completed.

Conclusions: The study demonstrated that a novel social support intervention involving support from participants' close social networks, delivered via app and website, has potential to promote weight loss and is feasible and acceptable.

Trial Registration: ISRCTN, ISRCTN85615983. Registered 25 September 2014.
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http://dx.doi.org/10.1186/s40814-020-00656-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7501712PMC
September 2020

Fluoride Varnish in Nursery Schools: A Randomised Controlled Trial - Protecting Teeth @3.

Caries Res 2020 10;54(3):274-282. Epub 2020 Sep 10.

Community Oral Health, University of Glasgow Dental School (MVLS), Glasgow, United Kingdom.

Studies suggest that fluoride varnish (FV) application can reduce dental caries in child populations. The multiple-component national child oral health improvement programme in Scotland (Childsmile) includes nursery-based universal supervised toothbrushing and deprivation-targeted FV applications, together with community and dental practice prevention interventions. This trial, a double-blind, two-arm randomised control trial, aimed to assess the effectiveness and cost-effectiveness of the nursery-based FV applications plus treatment-as-usual (TAU) Childsmile programme interventions, compared to TAU Childsmile interventions alone, in children not targeted to receive nursery FV as part of the programme. Participating children in the first year of nursery (aged three), with or without existing caries, were randomised to either FV or TAU and followed up for 24 months until the first year of primary school. Treatments were administered at six-monthly intervals. The primary endpoint was "worsening of d3mft" from baseline to 24 months. Secondary endpoints were worsening of d3mfs, d3t, mt, and ft. Individual record-linkage captured wider programme activities and tertiary endpoints. A total of 1,284 children were randomised, leading to 1,150 evaluable children (n = 577 FV, n = 573 TAU, 10% dropouts). Mean age was 3.5 years, 50% were female (n = 576), 17% had caries at baseline (n = 195), all balanced between the groups. Most children received three/four treatments. Overall, 26.9% (n = 155) had worsened d3mft in the FV group, and 31.6% (n = 181) in the TAU group, with an odds ratio (OR) of 0.80 (0.62-1.03), p = 0.078. The results for worsening of the secondary endpoints were: d3mfs 0.79 (0.61-1.01) p = 0.063, d3t 0.75 (0.57-0.99) p = 0.043, mt 1.34 (0.75-2.39) p = 0.319, and ft 0.77 (0.53-1.14) p = 0.191. We calculated a number needed to treat of 21 and a cost of GBP 686 to prevent a single worsening of d3mft. There was a modest non-significant reduction in the worsening of d3mft in the nursery FV group compared to TAU, suggesting that this intervention is unlikely to represent an effective or cost-effective addition to the population oral health improvement programme.
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http://dx.doi.org/10.1159/000509680DOI Listing
January 2021

Systematic Review of Economic Evaluations of Primary Caries Prevention in 2- to 5-Year-Old Preschool Children.

Value Health 2020 08 12;23(8):1109-1118. Epub 2020 Jul 12.

Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, Scotland, UK.

Objectives: To describe and summarize evidence on economic evaluations (EEs) of primary caries prevention in preschool children aged 2 to 5 years and to evaluate the reporting quality of full EE studies using a quality assessment tool.

Methods: A systematic literature search was conducted in several databases. Full and partial EEs were included. The reporting quality of full EE studies was assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist.

Results: A total of 808 studies were identified, and 39 were included in the review. Most papers were published between 2000 and 2017 and originated in the United States and the United Kingdom. The most common type of intervention investigated was a complex multicomponent intervention, followed by water fluoridation. Cost analysis and cost-effectiveness analysis were the most frequently used types of EE. One study employed cost-utility analysis. The proportion of full EEs increased over time. The parameters not reported well included study perspective, baseline year, sensitivity analysis, and discount rate. The CHEERS items that were most often unmet were characterizing uncertainty, study perspective, study parameters, and estimating resources and costs.

Conclusions: Within the past 2 decades, there has been an increase in the number of EEs of caries prevention interventions in preschool children. There was inconsistency in how EEs were conducted and reported. Lack of preference-based health-related quality-of-life measure utilization in the field was identified. The use of appropriate study methodologies and greater attention to recommended EE design are required to further improve quality.
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http://dx.doi.org/10.1016/j.jval.2020.04.1823DOI Listing
August 2020

Cost-effectiveness of the PDSAFE personalised physiotherapy intervention for fall prevention in Parkinson's: an economic evaluation alongside a randomised controlled trial.

BMC Neurol 2020 Aug 11;20(1):295. Epub 2020 Aug 11.

Health Economics and Health Technology Assessment (HEHTA), Institute of Health & Wellbeing, University of Glasgow, 1 Lilybank gardens, Glasgow, G12 8RZ, UK.

Background: PDSAFE is an individually-tailored, physiotherapist-delivered, balance, strength and strategy training programme aimed at preventing falls among people with Parkinson's. We evaluated the cost-effectiveness of PDSAFE compared with usual care for people with Parkinson's at higher risk of falling, from a UK National Health Service and Personal Social Service perspective.

Methods: Resource use and quality of life data (EQ-5D-3L) were collected from 238 participants randomised to the PDSAFE intervention and 236 participants randomised to control, at baseline, 3 months, 6 months (primary outcome), and 12 months. Adjusted cost and quality-adjusted life-years (QALYs) were estimated using generalised linear models and uncertainty estimated using a non-parametric bootstrap.

Results: Over 6 months, the PDSAFE intervention was associated with an incremental cost of £925 (95% CI £428 to £1422) and a very small and statistically insignificant QALY gain of 0.008 (95% CI - 0.006 to 0.021). The resulting incremental cost-effectiveness ratio (ICER) was £120,659 per QALY and the probability of the intervention being cost-effective at a UK threshold of £30,000/QALY was less than 1%. The ICER varied substantially across subgroups although no subgroup had an ICER lower than the £30,000 threshold. The result was sensitive to the time horizon with the ICER reducing to £55,176 per QALY when adopting a 12-month time horizon and assuming a sustained treatment effect on QoL, nevertheless, the intervention was still not cost-effective according to the current UK threshold.

Conclusions: Evidence from this trial suggests that the PDSAFE intervention is unlikely to be cost-effective at 6 months. The 12-month analysis suggested that the intervention became closer to being cost-effective if quality of life effects were sustained beyond the intervention period, however this would require confirmation. Further research, including qualitative studies, should be conducted to better understand the treatment effect of physiotherapy and its impact on quality of life in people with Parkinson's given existing mixed evidence on this topic.

Trial Registration: ISRCTN48152791. Registered 17 April 2014. http://www.isrctn.com/ISRCTN48152791.
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http://dx.doi.org/10.1186/s12883-020-01852-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7418432PMC
August 2020

Participant expectations and experiences of a tailored physiotherapy intervention for people with Parkinson's and a history of falls.

Disabil Rehabil 2020 Jun 23:1-9. Epub 2020 Jun 23.

Biomedical Research Centre, University of Southampton, Southampton, UK.

People with Parkinson's are twice as likely to fall as older people within the general population. This longitudinal qualitative study was part of a larger programme of research including a randomised controlled trial to test the effectiveness of a tailored physiotherapy intervention. Specific qualitative aims focused on a subsample of trial participants in the intervention arm of the trial, and comprised the following:To explore the expectations of participants about the intervention.To investigate participants' experiences of the intervention, and its perceived impacts.To understand the facilitators and barriers to engagement. Two semi-structured interviews were completed with a theoretical sample of people with Parkinson's from the intervention arm, initially after randomisation but before the intervention commenced, and then again six months later. Forty-two participants out of a large clinical trial were interviewed initially, with 37 agreeing to a second interview at six months. Prior experience of rehabilitation plus information accessed through the trial consent procedure informed participants' realistic expectations. Most found the level of the intervention acceptable, and perceived a range of benefits. However, views about equipment provided were more equivocal. The biggest barriers to participation were time and motivation, whilst social support facilitated engagement with the intervention. This study is the first to capture expectations about participation in a programme of exercises and strategies. It highlights that previous challenges to engagement in physical exercises and activities are not a barrier to future participation and provides new insights into the role of equipment and technology in programmes of physical activity for people with Parkinson's. The challenge of ensuring that programmes of exercise and strategies become an embedded feature of everyday life is highlighted, particularly alongside busy social engagements and leisure pursuits.Implications for rehabilitationFor people with Parkinsons, a programme of exercises and strategies has the potential to reduce the risk of falls amongst those with a history of falling.Adherence to such programmes can prove challenging for a variety of reasons, even when participants have realistic expectations about the commitment and effort needed.Clear explanations about the role of equipment and technology within such programmes could enhance adherence.In order to further individualise programmes of exercise for people with Parkinsons, choice regarding social support, reminders and integration into everyday activities should be explored.
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http://dx.doi.org/10.1080/09638288.2020.1779824DOI Listing
June 2020

Economic burden of rheumatoid arthritis: a systematic review of literature in biologic era.

Ann Rheum Dis 2020 06 3;79(6):771-777. Epub 2020 Apr 3.

Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.

Background: The past decades have seen rapid advances in the treatment of rheumatoid arthritis (RA). In particular, the introduction of biologic and targeted synthetic disease-modifying antirheumatic drugs have improved clinical outcomes and reconfigured traditional RA cost compositions.

Objectives: To map the existing evidence concerning cost of illness of RA, as the treatment pathway evolves in the biologic era, and examine how costs have been measured and estimated, in order to assemble and appropriately interpret available data.

Methods: Systematic review of studies that estimated the costs of patients with RA. Multiple electronic databases were searched to identify studies published between 2000 and 2019. The reported total costs and cost components were evaluated according to the study and population characteristics. The Cochran-Armitage test was used to determine statistically significant trends in increasing or decreasing proportions over time.

Results: Overall, 72 studies were included. Drug costs compromised the main component (up to 87%) of direct costs with an increasing trajectory over time, although not statistically significant. The proportion of costs for hospitalisation showed a statistically significant decrease chronologically (p=0.044). Indirect costs, primarily associated with absenteeism and work disability accounted for 39% to 86% of total costs. The reported indirect costs are highly sensitive to the approach to estimation.

Conclusions: A decreasing trend in inpatient costs chronologically suggested a cost shift in other components of direct costs. Indirect costs still contributed a considerable proportion of total costs, with work disability being the main cost component. Economic analyses that do not incorporate or appropriately measure indirect costs will underestimate the full economic impact of RA.
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http://dx.doi.org/10.1136/annrheumdis-2019-216243DOI Listing
June 2020

Accelerometer-Measured Sedentary and Physical Activity Time and Their Correlates in European Older Adults: The SITLESS Study.

J Gerontol A Biol Sci Med Sci 2020 09;75(9):1754-1762

Fundació Salut i Envelliment, Universitat Autònoma de Barcelona, Spain.

Background: Sedentary behavior (SB) and physical activity (PA) are important determinants of health in older adults. This study aimed to describe the composition of accelerometer-measured SB and PA in older adults, to explore self-reported context-specific SB, and to assess sociodemographic and functional correlates of engaging in higher levels of SB in participants of a multicenter study including four European countries.

Method: One thousand three hundred and sixty community-dwelling older adults from the SITLESS study (61.8% women; 75.3 ± 6.3 years) completed a self-reported SB questionnaire and wore an ActiGraph accelerometer for 7 days. Accelerometer-determined compositional descriptive statistics were calculated. A fixed-effects regression analysis was conducted to assess the sociodemographic (country, age, sex, civil status, education, and medications) and functional (body mass index and gait speed) correlates.

Results: Older adults spent 78.8% of waking time in SB, 18.6% in light-intensity PA, and 2.6% in moderate-to-vigorous PA. Accelerometry showed that women engaged in more light-intensity PA and walking and men engaged in higher amounts of moderate-to-vigorous PA. Watching television and reading accounted for 47.2% of waking time. Older age, being a man, single, taking more medications, being obese and overweight, and having a slower gait speed were statistically significant correlates of more sedentary time.

Conclusions: The high amount of SB of our participants justifies the need to develop and evaluate interventions to reduce sitting time. A clinically relevant change in gait speed can decrease almost 0.45 percentage points of sedentary time. The distribution of context-specific sedentary activities by country and sex showed minor differences, albeit worth noting.
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http://dx.doi.org/10.1093/gerona/glaa016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7494025PMC
September 2020

Participant experiences in a feasibility trial of supervised exercise training in adults with venous leg ulcers: A qualitative study.

Int Wound J 2019 Dec 13;16(6):1559-1569. Epub 2019 Oct 13.

The Centre for Sport and Exercise Science, Collegiate Hall, Sheffield Hallam University, Sheffield, UK.

Exercise training can improve lower-limb cutaneous microvascular reactivity in adults with venous leg ulceration; however, there is a lack of research on patients' views about the acceptability and feasibility of exercise interventions. The aim of this study was to explore participants' experiences of the trial "Exploring the Feasibility of Implementing a Supervised Exercise Training and Compression Hosiery Intervention in Patients with Venous Ulceration" (FISCU). Semi-structured face-to-face and telephone interviews were used to investigate participants' experiences (n = 16) of taking part in the FISCU trial. Data were analysed using thematic analysis. Three overarching themes were identified, along with 11 sub-themes: (a) sedentary cautious living (because of pain and reduced mobility, treatment and perceived control, and advice to rest and be careful), (b) key components of the exercise trial (including motivation, an individualised intervention supervised by a specialist exercise professional, and satisfaction with the intervention), and (c) benefits of exercise (physical benefits and healing, psychological well-being, positive impact on comorbidities, and an improved self-management strategy). This study found that an exercise intervention was viewed by participants as positive, acceptable, and feasible while living with a venous leg ulcer. An individualised and supervised exercise programme was key to build confidence to exercise.
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http://dx.doi.org/10.1111/iwj.13252DOI Listing
December 2019

Correction to: Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps for those with additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: study protocol for a randomised controlled trial.

Trials 2019 Sep 10;20(1):557. Epub 2019 Sep 10.

Medical Research Council/Chief Scientist Office Social and Public Health Sciences Unit, University of Glasgow, Top Floor 200 Renfield Street, Glasgow, G2 3AX, Scotland.

Following publication of the original article [1], it has been brought to our attention that an error was slipped into the article's title.
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http://dx.doi.org/10.1186/s13063-019-3674-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6737664PMC
September 2019

Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: study protocol for a randomised controlled trial.

Trials 2019 Aug 14;20(1):499. Epub 2019 Aug 14.

Medical Research Council/Chief Scientist Office Social and Public Health Sciences Unit, University of Glasgow, Top Floor 200 Renfield Street, Glasgow, G2 3AX, Scotland.

Background: Growing evidence suggests that experiences in the early years play a major role in children's development in terms of health, wellbeing and educational attainment. The Trial of healthy relationship initiatives for the very early years (THRIVE) aims to evaluate two antenatal group interventions, Enhanced Triple P for Baby and Mellow Bumps, designed for those with additional health or social care needs in pregnancy. As both interventions aim to improve maternal mental health and parenting skills, we hypothesise that in the longer term, participation may lead to an improvement in children's life trajectories.

Methods: THRIVE is a three-arm, longitudinal, randomised controlled trial aiming to recruit 500 pregnant women with additional health or social care needs. Participants will be referred by health and social care professionals, predominately midwives. Consenting participants will be block randomised to one of the three arms: Enhanced Triple P for Baby plus care as usual, Mellow Bumps plus care as usual or care as usual. Groups will commence when participants are between 20 and 34 weeks pregnant.

Discussion: The population we aim to recruit are traditionally referred to as "hard to reach", therefore we will monitor referrals received from maternity and social care pathways and will be open to innovation to boost referral rates. We will set geographically acceptable group locations for participants, to limit challenges we foresee for group participation and retention. We anticipate the results of the trial will help inform policy and practice in supporting women with additional health and social care needs during antenatal and early postnatal periods. This is currently a high priority for the Scottish and UK Governments.

Trial Registration: International Standard Randomised Controlled Trials Number (ISRCTN) Registry, ISRCTN:21656568 . Registered on 28 February 2014 (registered retrospectively (by 3 months)).
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http://dx.doi.org/10.1186/s13063-019-3571-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6694522PMC
August 2019

A randomised controlled trial of treatments of childhood anxiety disorder in the context of maternal anxiety disorder: clinical and cost-effectiveness outcomes.

J Child Psychol Psychiatry 2020 01 31;61(1):62-76. Epub 2019 Jul 31.

School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK.

Background: This study evaluated whether clinical and economic outcomes from CBT for child anxiety disorders in the context of maternal anxiety disorders are improved by adding treatment focused on (a) maternal anxiety disorders or (b) mother-child interactions.

Methods: Two hundred and eleven children (7-12 years, 85% White British, 52% female) with a primary anxiety disorder, whose mothers also had a current anxiety disorder, were randomised to receive (a) child-focused CBT with nonspecific control interventions (CCBT+Con), (b) CCBT with CBT for the maternal anxiety disorder (CCBT+MCBT), or (c) CCBT with an intervention targeting the mother-child interaction (CCBT+MCI). A cost-utility analysis from a societal perspective was conducted using mother/child combined quality-adjusted life years (QALYs). [Trial registration: https://doi.org/10.1186/isrctn19762288].

Results: MCBT was associated with immediate reductions in maternal anxiety compared to the nonspecific control; however, after children had also received CCBT, maternal outcomes in the CCBT+MCI and CCBT+Con arms improved and CCBT+MCBT was no longer superior. Neither CCBT+MCBT nor CCBT+MCI conferred a benefit over CCBT+Con in terms of child anxiety disorder diagnoses post-treatment [primary outcome] (adj RR: 1.22 (95% CI: 0.88, 1.67), p = .23; adj RR: 1.21 (95% CI: 0.88, 1.65), p = .24, respectively) or global improvement ratings (adj RR: 1.25 (95% CI: 0.99, 1.57), p = .06; adj RR: 1.18 (95% CI: 0.93, 1.50), p = .17) or six and 12 months later. No significant differences between the groups were found on the main economic outcome measures (child/mother combined QALY mean difference: CCBT+MCBT vs. CCBT+Con: -0.04 (95% CI: -0.12, 0.04), p = .29; CCBT+MCI vs. CCBT+Con: 0.02 (95% CI: -0.05, -0.09), p = .54). CCBT+MCI was associated with nonsignificantly higher costs than CCBT (mean difference: £154 (95% CI: -£1,239, £1,547), p = .83) but, when taking into account sampling uncertainty, it may be cost-effective compared with CCBT alone.

Conclusions: Good outcomes were achieved for children and their mothers across treatment arms. There was no evidence of significant clinical benefit from supplementing CCBT with either CBT for the maternal anxiety disorder or treatment focussed on mother-child interactions, but the addition of MCI (and not MCBT) may be cost-effective.
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http://dx.doi.org/10.1111/jcpp.13089DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6916180PMC
January 2020

Exercise- and strategy-based physiotherapy-delivered intervention for preventing repeat falls in people with Parkinson's: the PDSAFE RCT.

Health Technol Assess 2019 07;23(36):1-150

Faculty of Health Science, University of Southampton, Southampton, UK.

Background: People with Parkinson's disease are twice as likely to experience a fall as a healthy older person, often leading to debilitating effects on confidence, activity levels and quality of life.

Objective: To estimate the effect of a physiotherapy programme for fall prevention among people with Parkinson's disease.

Design: A multicentre, pragmatic, investigator-masked, individually randomised controlled trial (RCT) with prespecified subgroup analyses.

Setting: Recruitment from NHS hospitals and clinics and community and social services in eight English regions with home-based interventions.

Participants: A total of 474 people with Parkinson's disease (i.e. Hoehn and Yahr scale stages 1-4) were recruited: 238 were assigned to a physiotherapy programme and 236 were assigned to usual care. Random allocation was 50 : 50.

Interventions: All participants received routine care; the usual-care group received an information digital versatile disc (DVD) and a single advice session at trial completion. The intervention group had an individually tailored, progressive, home-based fall avoidance strategy training programme with balance and strengthening exercises: PDSAFE.

Main Outcome Measures: The primary outcome was the risk of repeat falling, collected by self-report monthly diaries between 0 and 6 months after randomisation. Secondary outcomes included near-falls, falls efficacy, freezing of gait (FoG), health-related quality of life, and measurements taken using the Mini-Balance Evaluation Systems Test (Mini-BESTest), the Chair Stand Test (CST), the Geriatric Depression Scale, the Physical Activity Scale for the Elderly and the Parkinson's Disease Questionnaire.

Results: PDSAFE is the largest RCT of falls management among people with Parkinson's disease: 541 patients were screened for eligibility. The average age was 72 years, and 266 out of 474 (56%) participants were men. Of the 474 randomised participants, 238 were randomised to the intervention group and 236 were randomised to the control group. No difference in repeat falling within 6 months of randomisation was found [PDSAFE group to control group odds ratio (OR) 1.21, 95% confidence interval (CI) 0.74 to 1.98;  = 0.447]. An analysis of secondary outcomes demonstrated better balance (Mini-BESTest: mean difference 0.95, 95% CI 0.24 to 1.67;  = 0.009), functional strength (CST:  = 0.041) and falls efficacy (Falls Efficacy Scale - International: mean difference 1.6, 95% CI -3.0 to -0.19;  = 0.026) with near-falling significantly reduced with PDSAFE (OR 0.67, 95% CI 0.53 to 0.86;  = 0.001) at 6 months. Prespecified subgroup analysis (i.e. disease severity and FoG) revealed a PDSAFE differing effect; the intervention may be of benefit for people with moderate disease but may increase falling for those in the more severe category, especially those with FoG.

Limitations: All participants were assessed at primary outcome; only 73% were assessed at 12 months owing to restricted funding.

Conclusions: PDSAFE was not effective in reducing repeat falling across the range of people with Parkinson's disease in the trial. Secondary analysis demonstrated that other functional tasks and self-efficacy improved and demonstrated differential patterns of intervention impact in accordance with disease severity and FoG, which supports previous secondary research findings and merits further primary evaluation.

Future Work: Further trials of falls prevention on targeted groups of people with Parkinson's disease are recommended.

Trial Registration: Current Controlled Trials ISRCTN48152791.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 23, No. 36. See the NIHR Journals Library website for further project information. Sarah E Lamb is funded by the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) at Oxford Health NHS Foundation Trust, the NIHR Oxford Biomedical Research Centre at the Oxford University Hospitals NHS Foundation Trust and CLAHRC Oxford. Victoria A Goodwin is supported by the NIHR Collaborations for Leadership in Applied Health Research and Care in the South West Peninsula (PenCLAHRC). Lynn Rochester is supported by the NIHR Newcastle Biomedical Research Centre based at Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University. The research was also supported by the NIHR Newcastle Clinical Research Facility Infrastructure funding. Helen C Roberts is supported by CLAHRC Wessex and the NIHR Southampton Biomedical Research Centre.
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http://dx.doi.org/10.3310/hta23360DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6680369PMC
July 2019

Exercise referral schemes enhanced by self-management strategies to reduce sedentary behaviour and increase physical activity among community-dwelling older adults from four European countries: protocol for the process evaluation of the SITLESS randomised controlled trial.

BMJ Open 2019 06 14;9(6):e027073. Epub 2019 Jun 14.

Fundació Salut i Envelliment (Foundation on Health and Ageing)- UAB, Universitat Autònoma de Barcelona, Barcelona, Spain.

Introduction: SITLESS is a randomised controlled trial determining whether exercise referral schemes can be enhanced by self-management strategies to reduce sedentary behaviour and increase physical activity in the long term, in community-dwelling older citizens. The intervention is complex and requires a process evaluation to understand how implementation, causal mechanisms and context shape outcomes. The specific aims are to assess fidelity and reach of the implementation, understand the contextual aspects of each intervention site, evaluate the mechanisms of impact, and explore perceived effects.

Methods And Analysis: Following the Medical Research Council guidance on complex interventions, a combination of qualitative and quantitative procedures is applied, including observational checklists and attendance registries, standardised scales (ie, Marcus's Self-Efficacy Questionnaire, Physical Activity Self-Regulation Scale and the Lubben Social Network Scale) at baseline, postintervention and follow-up assessments, semistructured questionnaires gathering contextual characteristics, and participant observations of the sessions. Semistructured interviews and focus groups with the participants and trainers are conducted at postintervention and during the follow-up to explore their experiences. Outcomes from the standardised scales are analysed as moderators within the impact evaluation. Descriptive results on context and perceived effects complement results on impact. The qualitative and quantitative findings will help to refine the logic model to finally support the interpretation of the results on the effectiveness of the intervention.

Ethics And Dissemination: The study design was approved by the respective Ethical Committee of Ramon Llull University, Southern Denmark, Northern Ireland and Ulm University. Participation is voluntary, and all participants are asked to sign informed consent before starting the study. A dissemination plan operationalises how to achieve a social impact by reaching academic and non-academic stakeholders. A data management plan describes the specific data sets and regulates its deposition and curation. All publications will be open access.

Trial Registration Number: NCT02629666; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2018-027073DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6588992PMC
June 2019

Multicentre, randomised controlled trial of PDSAFE, a physiotherapist-delivered fall prevention programme for people with Parkinson's.

J Neurol Neurosurg Psychiatry 2019 07 3;90(7):774-782. Epub 2019 Apr 3.

School of Health Sciences, University of Southampton, Southampton, UK

Objective: To estimate the effect of a physiotherapist-delivered fall prevention programme for people with Parkinson's (PwP).

Methods: People at risk of falls with confirmed Parkinson's were recruited to this multicentre, pragmatic, investigator blind, individually randomised controlled trial with prespecified subgroup analyses. 474 PwP (Hoehn and Yahr 1-4) were randomised: 238 allocated to a physiotherapy programme and 236 to control. All participants had routine care; the control group received a DVD about Parkinson's and single advice session at trial completion. The intervention group (PDSAFE) had an individually tailored, progressive home-based fall avoidance strategy training programme with balance and strengthening exercises. The primary outcome was risk of repeat falling, collected by self-report monthly diaries, 0-6 months after randomisation. Secondary outcomes included Mini-BESTest for balance, chair stand test, falls efficacy, freezing of gait, health-related quality of life (EuroQol EQ-5D), Geriatric Depression Scale, Physical Activity Scale for the Elderly and Parkinson's Disease Questionnaire, fractures and rate of near falling.

Results: Average age is 72 years and 266 (56%) were men. By 6 months, 116 (55%) of the control group and 125 (61.5%) of the intervention group reported repeat falls (controlled OR 1.21, 95% CI 0.74 to 1.98, p=0.447). Secondary subgroup analyses suggested a different response to the intervention between moderate and severe disease severity groups. Balance, falls efficacy and chair stand time improved with near falls reduced in the intervention arm.

Conclusion: PDSAFE did not reduce falling in this pragmatic trial of PwP. Other functional tasks improved and reduced fall rates were apparent among those with moderate disease.

Trial Registration Number: ISRCTN48152791.
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http://dx.doi.org/10.1136/jnnp-2018-319448DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6585265PMC
July 2019

Using Nominal Group Technique to Identify Key Attributes of Oncology Treatments for a Discrete Choice Experiment.

MDM Policy Pract 2019 Jan-Jun;4(1):2381468319837925. Epub 2019 Mar 20.

Memorial Sloan Kettering Cancer Center, New York.

Responding to rising oncology therapy costs, multiple value frameworks are emerging. However, input from economists in their design and conceptualization has been limited, and no existing framework has been developed using preference weightings as legitimate indicators of value. This article outlines use of the nominal group technique to identify valued treatment attributes (such as treatment inconvenience) and contextual considerations (such as current life expectancy) to inform the design of a discrete choice experiment to develop a preference weighted value framework for future decision makers. Three focus groups were conducted in 2017 with cancer patients, oncology physicians, and nurses. Using the nominal group technique, participants identified and prioritized cancer therapy treatment and delivery attributes as well as contextual issues considered when choosing treatment options. Focus groups with patients ( = 8), physicians ( = 6), and nurses ( = 10) identified 30 treatment attributes and contextual considerations. Therapy health gains was the first priority across all groups. Treatment burden/inconvenience to patients and their families and quality of evidence were prioritized treatment attributes alongside preferences for resource use and cost (to patients and society) attributes. The groups also demonstrated that contextual considerations when choosing treatment varied across the stakeholders. Patients prioritized existence of alternative treatments and oncologist/center reputation while nurses focused on administration harms, communication, and treatment innovation. The physicians did not prioritize any contextual issues in their top rankings. The study demonstrates that beyond health gains, there are treatment attributes and contextual considerations that are highly prioritized across stakeholder groups. These represent important candidates for inclusion in a discrete choice experiment seeking to provide weighted preferences for a value framework for oncology treatment that goes beyond health outcomes.
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http://dx.doi.org/10.1177/2381468319837925DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6429659PMC
March 2019

Valuing Mobile Health: An Open-Ended Contingent Valuation Survey of a National Digital Health Program.

JMIR Mhealth Uhealth 2019 01 17;7(1):e3. Epub 2019 Jan 17.

Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, United Kingdom.

Background: Changing population demographics and technology developments have resulted in growing interest in the potential of consumer-facing digital health. In the United Kingdom, a £37 million (US $49 million) national digital health program delivering assisted living lifestyles at scale (dallas) aimed to deploy such technologies at scale. However, little is known about how consumers value such digital health opportunities.

Objective: This study explored consumers' perspectives on the potential value of digital health technologies, particularly mobile health (mHealth), to promote well-being by examining their willingness-to-pay (WTP) for such health solutions.

Methods: A contingent valuation study involving a UK-wide survey that asked participants to report open-ended absolute and marginal WTP or willingness-to-accept for the gain or loss of a hypothetical mHealth app, Healthy Connections.

Results: A UK-representative cohort (n=1697) and a dallas-like (representative of dallas intervention communities) cohort (n=305) were surveyed. Positive absolute and marginal WTP valuations of the app were identified across both cohorts (absolute WTP: UK-representative cohort £196 or US $258 and dallas-like cohort £162 or US $214; marginal WTP: UK-representative cohort £160 or US $211 and dallas-like cohort £151 or US $199). Among both cohorts, there was a high prevalence of zeros for both the absolute WTP (UK-representative cohort: 467/1697, 27.52% and dallas-like cohort: 95/305, 31.15%) and marginal WTP (UK-representative cohort: 487/1697, 28.70% and dallas-like cohort: 99/305, 32.5%). In both cohorts, better general health, previous amount spent on health apps (UK-representative cohort 0.64, 95% CI 0.27 to 1.01; dallas-like cohort: 1.27, 95% CI 0.32 to 2.23), and age had a significant (P>.00) association with WTP (UK-representative cohort: -0.1, 95% CI -0.02 to -0.01; dallas-like cohort: -0.02, 95% CI -0.03 to -0.01), with younger participants willing to pay more for the app. In the UK-representative cohort, as expected, higher WTP was positively associated with income up to £30,000 or US $39,642 (0.21, 95% CI 0.14 to 0.4) and increased spending on existing phone and internet services (0.52, 95% CI 0.30 to 0.74). The amount spent on existing health apps was shown to be a positive indicator of WTP across cohorts, although the effect was marginal (UK-representative cohort 0.01, 95% CI 0.01 to 0.01; dallas-like cohort 0.01, 95% CI 0.01 to 0.02).

Conclusions: This study demonstrates that consumers value mHealth solutions that promote well-being, social connectivity, and health care control, but it is not universally embraced. For mHealth to achieve its potential, apps need to be tailored to user accessibility and health needs, and more understanding of what hinders frequent users of digital technologies and those with long-term conditions is required. This novel application of WTP in a digital health context demonstrates an economic argument for investing in upskilling the population to promote access and expedite uptake and utilization of such digital health and well-being apps.
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http://dx.doi.org/10.2196/mhealth.9990DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6354197PMC
January 2019

An evaluation of the effects of lowering blood alcohol concentration limits for drivers on the rates of road traffic accidents and alcohol consumption: a natural experiment.

Lancet 2019 01 12;393(10169):321-329. Epub 2018 Dec 12.

Public Health Observatory, NHS Health Scotland, Glasgow, UK.

Background: Drink driving is an important risk factor for road traffic accidents (RTAs), which cause high levels of morbidity and mortality globally. Lowering the permitted blood alcohol concentration (BAC) for drivers is a common public health intervention that is enacted in countries and jurisdictions across the world. In Scotland, on Dec 5, 2014, the BAC limit for drivers was reduced from 0·08 g/dL to 0·05 g/dL. We therefore aimed to evaluate the effects of this change on RTAs and alcohol consumption.

Methods: In this natural experiment, we used an observational, comparative interrupted time-series design by use of data on RTAs and alcohol consumption in Scotland (the interventional group) and England and Wales (the control group). We obtained weekly counts of RTAs from police accident records and we estimated weekly off-trade (eg, in supermarkets and convenience stores) and 4-weekly on-trade (eg, in bars and restaurants) alcohol consumption from market research data. We also used data from automated traffic counters as denominators to calculate RTA rates. We estimated the effect of the intervention on RTAs by use of negative binomial panel regression and on alcohol consumption outcomes by use of seasonal autoregressive integrated moving average models. Our primary outcome was weekly rates of RTAs in Scotland, England, and Wales. This study is registered with ISRCTN, number ISRCTN38602189.

Findings: We assessed the weekly rate of RTAs and alcohol consumption between Jan 1, 2013, and Dec 31, 2016, before and after the BAC limit came into effect on Dec 5, 2014. After the reduction in BAC limits for drivers in Scotland, we found no significant change in weekly RTA rates after adjustment for seasonality and underlying temporal trend (rate ratio 1·01, 95% CI 0·94-1·08; p=0.77) or after adjustment for seasonality, the underlying temporal trend, and the driver characteristics of age, sex, and socioeconomic deprivation (1·00, 0·96-1·06; p=0·73). Relative to RTAs in England and Wales, where the reduction in BAC limit for drivers did not occur, we found a 7% increase in weekly RTA rates in Scotland after this reduction in BAC limit for drivers (1·07, 1·02-1·13; p=0·007 in the fully-adjusted model). Similar findings were observed for serious or fatal RTAs and single-vehicle night-time RTAs. The change in legislation in Scotland was associated with no change in alcohol consumption, measured by per-capita off-trade sales (-0·3%, -1·7 to 1·1; p=0·71), but a 0·7% decrease in alcohol consumption measured by per-capita on-trade sales (-0·7%, -0·8 to -0·5; p<0·0001).

Interpretation: Lowering the driving BAC limit to 0·05 g/dL from 0·08 g/dL in Scotland was not associated with a reduction in RTAs, but this change was associated with a small reduction in per-capita alcohol consumption from on-trade alcohol sales. One plausible explanation is that the legislative change was not suitably enforced-for example with random breath testing measures. Our findings suggest that changing the legal BAC limit for drivers in isolation does not improve RTA outcomes. These findings have significant policy implications internationally as several countries and jurisdictions consider a similar reduction in the BAC limit for drivers.

Funding: National Institute for Health Research Public Health Research Programme.
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http://dx.doi.org/10.1016/S0140-6736(18)32850-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6346081PMC
January 2019

Effectiveness and cost-effectiveness of a loyalty scheme for physical activity behaviour change maintenance: results from a cluster randomised controlled trial.

Int J Behav Nutr Phys Act 2018 12 12;15(1):127. Epub 2018 Dec 12.

UKCRC Centre of Excellence for Public Health Research (NI)/Centre for Public Health, Queen's University Belfast, Grosvenor Road, Belfast, BT12 6BJ, Northern Ireland.

Background: We evaluated the effectiveness and cost-effectiveness of a loyalty scheme based intervention involving rewards for increasing physical activity in public sector employees.

Methods: A cluster randomised wait-list controlled trial in public sector organisations in Northern Ireland. We randomly assigned clusters (1:1) using a computer generated random sequence. Researchers were masked to allocation, but participants were not. Employees aged 18-65 years with no self-reported medical contraindications to physical activity were included. The Physical Activity Loyalty Scheme (PAL) intervention was based on high-street loyalty cards where participants earned points for minutes of activity that could be redeemed for rewards, complemented by evidence-based behaviour change techniques. The primary outcome was objectively measured mean steps/day at 6 months using a validated pedometer (Yamax Digi-Walker CW-701) over 7 days, assessed with intention to treat analysis. Secondary outcomes included health, mental wellbeing, quality of life, work absenteeism and presenteeism, and use of healthcare resources. Cost-effectiveness, cost-benefit and mediation analyses were conducted. Trial registered with Current Controlled Trials, number ISRCTN17975376.

Results: Between September 2014 and October 2015, we recruited and randomly assigned 37 clusters (from nine organisations; mean clusters per organisation = four) and 853 participants to the intervention (n = 19 with 457 participants) or control group (n = 18 with 396 participants). Primary outcome data were available for 249 (54·4%) intervention and 236 (59·6%) control participants. Mean steps/day were significantly lower in the intervention vs control group (adjusted mean difference = - 336, 95% CI: -612 to - 60, p = 0·02) at 6 months. Participants redeemed only 39% (SD 43%) of their earned points. Using the Quality Adjusted Life Year outcome, the intervention was not cost effective from an NHS/PSS perspective. A net cost analysis from an employer perspective demonstrated the intervention group was associated with a mean of 2·97 h less absenteeism over a 4 week period (p = 0·62), which could result in net savings ranging from £66 to £735 depending on the wage rate employed. At 4-weeks post-baseline there were significant increases in identified regulation, integrated regulation, intrinsic motivation, social norms and intentions in intervention compared to control participants.

Conclusions: Our mixed results pose challenges that are too infrequently exposed in public heath intervention trials. Although the intervention successfully altered several hypothesised mediating constructs it did not translate into long-term behaviour change. Our incentive level may have been too low to incentivise change, despite being designed a priori by a Contingent Valuation Survey. There were also major re-structuring of several organisations which presented significant implementation challenges, and technical limitations.

Trial Registration: ISRCTN17975376 (Registered 19/09/2014).
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http://dx.doi.org/10.1186/s12966-018-0758-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6291971PMC
December 2018

A framework for conducting economic evaluations alongside natural experiments.

Soc Sci Med 2019 01 27;220:353-361. Epub 2018 Nov 27.

Health Economics & Health Technology Assessment, Institute of Health & Wellbeing, University of Glasgow, 1 Lilybank Gardens, Glasgow, G12 8RZ, United Kingdom.

Internationally, policy makers are increasingly focussed on reducing the detrimental consequences and rising costs associated with unhealthy diets, inactivity, smoking, alcohol and other risk factors on the health of their populations. This has led to an increase in the demand for evidence-based, cost-effective Population Health Interventions (PHIs) to reverse this trend. Given that research designs such as randomised controlled trials (RCTs) are often not suited to the evaluation of PHIs, Natural Experiments (NEs) are now frequently being used as a design to evaluate such complex, preventive PHIs. However, current guidance for economic evaluation focusses on RCT designs and therefore does not address the specific challenges of NE designs. Using such guidance can lead to sub-optimal design, data collection and analysis for NEs, leading to bias in the estimated effectiveness and cost-effectiveness of the PHI. As a consequence, there is a growing recognition of the need to identify a robust methodological framework for the design and conducting of economic evaluations alongside such NEs. This paper outlines the challenges inherent to the design and conduct of economic evaluations of PHIs alongside NEs, providing a comprehensive framework and outlining a research agenda in this area.
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http://dx.doi.org/10.1016/j.socscimed.2018.11.032DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6323352PMC
January 2019

Cost-effectiveness of exercise referral schemes enhanced by self-management strategies to battle sedentary behaviour in older adults: protocol for an economic evaluation alongside the SITLESS three-armed pragmatic randomised controlled trial.

BMJ Open 2018 10 15;8(10):e022266. Epub 2018 Oct 15.

Health Economics and Health Technology Assessment (HEHTA), Institute of Health and Wellbeing (IHW), University of Glasgow, Glasgow, UK.

Introduction: Promoting physical activity (PA) and reducing sedentary behaviour (SB) may exert beneficial effects on the older adult population, improving behavioural, functional, health and psychosocial outcomes in addition to reducing health, social care and personal costs. This paper describes the planned economic evaluation of SITLESS, a multicountry three-armed pragmatic randomised controlled trial (RCT) which aims to assess the short-term and long-term effectiveness and cost-effectiveness of a complex intervention on SB and PA in community-dwelling older adults, based on exercise referral schemes enhanced by a group intervention providing self-management strategies to encourage lifestyle change.

Methods And Analysis: A within-trial economic evaluation and long-term model from both a National Health Service/personal social services perspective and a broader societal perspective will be undertaken alongside the SITLESS multinational RCT. Healthcare costs (hospitalisations, accident and emergency visits, appointment with health professionals) and social care costs (eg, community care) will be included in the economic evaluation. For the cost-utility analysis, quality-adjusted life-years will be measured using the EQ-5D-5L and capability well-being measured using the ICEpop CAPability measure for Older people (ICECAP-O) questionnaire. Other effectiveness outcomes (health related, behavioural, functional) will be incorporated into a cost-effectiveness analysis and cost-consequence analysis.The multinational nature of this RCT implies a hierarchical structure of the data and unobserved heterogeneity between clusters that needs to be adequately modelled with appropriate statistical and econometric techniques. In addition, a long-term population health economic model will be developed and will synthesise and extrapolate within-trial data with additional data extracted from the literature linking PA and SB outcomes with longer term health states.Methods guidance for population health economic evaluation will be adopted including the use of a long-time horizon, 1.5% discount rate for costs and benefits, cost consequence analysis framework and a multisector perspective.

Ethics And Dissemination: The study design was approved by the ethics and research committee of each intervention site: the Ethics and Research Committee of Ramon Llull University (reference number: 1314001P) (Fundació Blanquerna, Spain), the Regional Committees on Health Research Ethics for Southern Denmark (reference number: S-20150186) (University of Southern Denmark, Denmark), Office for Research Ethics Committees in Northern Ireland (ORECNI reference number: 16/NI/0185) (Queen's University of Belfast) and the Ethical Review Board of Ulm University (reference number: 354/15) (Ulm, Germany). Participation is voluntary and all participants will be asked to sign informed consent before the start of the study.This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement number 634 270. This article reflects only the authors' view and the Commission is not responsible for any use that may be made of the information it contains.The findings of the study will be disseminated to different target groups (academia, policymakers, end users) through different means following the national ethical guidelines and the dissemination regulation of the Horizon 2020 funding agency.Use of the EuroQol was registered with the EuroQol Group in 2016.Use of the ICECAP-O was registered with the University of Birmingham in March 2017.

Trial Registration Number: NCT02629666; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2018-022266DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6194476PMC
October 2018

Comment: Decentralized decision making through adaptive minimax regret-Complex yet intuitively appealing.

Authors:
Emma McIntosh

Health Econ 2018 10 2;27(10):1428-1430. Epub 2018 Aug 2.

Institute of Health and Wellbeing, Public Health and Health Policy, University of Glasgow, Glasgow, UK.

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http://dx.doi.org/10.1002/hec.3807DOI Listing
October 2018