Financial incentive interventions have been suggested as one method of promoting healthy behaviour change.
To conduct a systematic review of the effectiveness of financial incentive interventions for ...encouraging healthy behaviour change; to explore whether effects vary according to the type of behaviour incentivised, post-intervention follow-up time, or incentive value.
Searches were of relevant electronic databases, research registers, www.google.com, and the reference lists of previous reviews; and requests for information sent to relevant mailing lists.
Controlled evaluations of the effectiveness of financial incentive interventions, compared to no intervention or usual care, to encourage healthy behaviour change, in non-clinical adult populations, living in high-income countries, were included.
The Cochrane Risk of Bias tool was used to assess all included studies. Meta-analysis was used to explore the effect of financial incentive interventions within groups of similar behaviours and overall. Meta-regression was used to determine if effect varied according to post-intervention follow up time, or incentive value.
Seventeen papers reporting on 16 studies on smoking cessation (n = 10), attendance for vaccination or screening (n = 5), and physical activity (n = 1) were included. In meta-analyses, the average effect of incentive interventions was greater than control for short-term (≤ six months) smoking cessation (relative risk (95% confidence intervals): 2.48 (1.77 to 3.46); long-term (>six months) smoking cessation (1.50 (1.05 to 2.14)); attendance for vaccination or screening (1.92 (1.46 to 2.53)); and for all behaviours combined (1.62 (1.38 to 1.91)). There was not convincing evidence that effects were different between different groups of behaviours. Meta-regression found some, limited, evidence that effect sizes decreased as post-intervention follow-up period and incentive value increased. However, the latter effect may be confounded by the former.
The available evidence suggests that financial incentive interventions are more effective than usual care or no intervention for encouraging healthy behaviour change.
PROSPERO CRD42012002393.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Summary Background Whole brain radiotherapy (WBRT) and dexamethasone are widely used to treat brain metastases from non-small cell lung cancer (NSCLC), although there have been no randomised clinical ...trials showing that WBRT improves either quality of life or overall survival. Even after treatment with WBRT, the prognosis of this patient group is poor. We aimed to establish whether WBRT could be omitted without a significant effect on survival or quality of life. Methods The Quality of Life after Treatment for Brain Metastases (QUARTZ) study is a non-inferiority, phase 3 randomised trial done at 69 UK and three Australian centres. NSCLC patients with brain metastases unsuitable for surgical resection or stereotactic radiotherapy were randomly assigned (1:1) to optimal supportive care (OSC) including dexamethasone plus WBRT (20 Gy in five daily fractions) or OSC alone (including dexamethasone). The dose of dexamethasone was determined by the patients' symptoms and titrated downwards if symptoms improved. Allocation to treatment group was done by a phone call from the hospital to the Medical Research Council Clinical Trials Unit at University College London using a minimisation programme with a random element and stratification by centre, Karnofsky Performance Status (KPS), gender, status of brain metastases, and the status of primary lung cancer. The primary outcome measure was quality-adjusted life-years (QALYs). QALYs were generated from overall survival and patients' weekly completion of the EQ-5D questionnaire. Treatment with OSC alone was considered non-inferior if it was no more than 7 QALY days worse than treatment with WBRT plus OSC, which required 534 patients (80% power, 5% one-sided significance level). Analysis was done by intention to treat for all randomly assigned patients. The trial is registered with ISRCTN, number ISRCTN3826061. Findings Between March 2, 2007, and Aug 29, 2014, 538 patients were recruited from 69 UK and three Australian centres, and were randomly assigned to receive either OSC plus WBRT (269) or OSC alone (269). Baseline characteristics were balanced between groups, and the median age of participants was 66 years (range 38–85). Significantly more episodes of drowsiness, hair loss, nausea, and dry or itchy scalp were reported while patients were receiving WBRT, although there was no evidence of a difference in the rate of serious adverse events between the two groups. There was no evidence of a difference in overall survival (hazard ratio 1·06, 95% CI 0·90–1·26), overall quality of life, or dexamethasone use between the two groups. The difference between the mean QALYs was 4·7 days (46·4 QALY days for the OSC plus WBRT group vs 41·7 QALY days for the OSC group), with two-sided 90% CI of −12·7 to 3·3. Interpretation Although the primary outcome measure result includes the prespecified non-inferiority margin, the combination of the small difference in QALYs and the absence of a difference in survival and quality of life between the two groups suggests that WBRT provides little additional clinically significant benefit for this patient group. Funding Cancer Research UK, Medical Research Council Clinical Trials Unit at University College London, and the National Health and Medical Research Council in Australia.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
The needs of children with autism spectrum disorder (ASD) are complex and this is reflected in the number and diversity of outcomes assessed and measurement tools used to collect evidence about ...children's progress. Relevant outcomes include improvement in core ASD impairments, such as communication, social awareness, sensory sensitivities and repetitiveness; skills such as social functioning and play; participation outcomes such as social inclusion; and parent and family impact.
To examine the measurement properties of tools used to measure progress and outcomes in children with ASD up to the age of 6 years. To identify outcome areas regarded as important by people with ASD and parents.
The MeASURe (Measurement in Autism Spectrum disorder Under Review) research collaboration included ASD experts and review methodologists. We undertook systematic review of tools used in ASD early intervention and observational studies from 1992 to 2013; systematic review, using the COSMIN checklist (Consensus-based Standards for the selection of health Measurement Instruments) of papers addressing the measurement properties of identified tools in children with ASD; and synthesis of evidence and gaps. The review design and process was informed throughout by consultation with stakeholders including parents, young people with ASD, clinicians and researchers.
The conceptual framework developed for the review was drawn from the International Classification of Functioning, Disability and Health, including the domains 'Impairments', 'Activity Level Indicators', 'Participation', and 'Family Measures'. In review 1, 10,154 papers were sifted - 3091 by full text - and data extracted from 184; in total, 131 tools were identified, excluding observational coding, study-specific measures and those not in English. In review 2, 2665 papers were sifted and data concerning measurement properties of 57 (43%) tools were extracted from 128 papers. Evidence for the measurement properties of the reviewed tools was combined with information about their accessibility and presentation. Twelve tools were identified as having the strongest supporting evidence, the majority measuring autism characteristics and problem behaviour. The patchy evidence and limited scope of outcomes measured mean these tools do not constitute a 'recommended battery' for use. In particular, there is little evidence that the identified tools would be good at detecting change in intervention studies. The obvious gaps in available outcome measurement include well-being and participation outcomes for children, and family quality-of-life outcomes, domains particularly valued by our informants (young people with ASD and parents).
This is the first systematic review of the quality and appropriateness of tools designed to monitor progress and outcomes of young children with ASD. Although it was not possible to recommend fully robust tools at this stage, the review consolidates what is known about the field and will act as a benchmark for future developments. With input from parents and other stakeholders, recommendations are made about priority targets for research.
Priorities include development of a tool to measure child quality of life in ASD, and validation of a potential primary outcome tool for trials of early social communication intervention.
This study is registered as PROSPERO CRD42012002223.
The National Institute for Health Research Health Technology Assessment programme.
Objectives
Data sharing is well established in biological research, but evidence on sharing of clinical trial or public health research study data remains limited, in particular studies of research ...participants’ perspectives of data sharing. This study systematically reviewed international evidence of research participants’ attitudes towards the sharing of data for secondary research use.
Methods
Systematic search of seven databases, and author-, citation- and bibliography-follow up to identify studies examining research participants’ attitudes towards data sharing. Studies were thematically analysed using NVivo v10 to identify recurring themes.
Results
Nine studies were eligible for inclusion. Thematic analysis identified four key themes: (1) benefits of data sharing, including benefit to participants or immediate community, benefits to the public and benefits to science or research; (2) fears and harms, such as fear of exploitation, stigmatization or repercussions, alongside concerns about confidentiality and misuse of data; (3) data sharing processes, in particular the role of consent in the process; and (4) the relationship between participants and research such as trust in different types of research or organization and the relationship with the original research team.
Conclusions
The available literature on attitudes towards sharing data from clinical trials or public health interventions remains scant. This study has identified four themes regarding research participants’ attitudes and preferences, which should be considered by policy makers, and explored with further research.
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BFBNIB, NMLJ, NUK, PNG, UL, UM, UPUK
Successful implementation and embedding of new health care practices relies on co-ordinated, collective behaviour of individuals working within the constraints of health care settings. Normalization ...Process Theory (NPT) provides a theory of implementation that emphasises collective action in explaining, and shaping, the embedding of new practices. To extend the practical utility of NPT for improving implementation success, an instrument (NoMAD) was developed and validated.
Descriptive analysis and psychometric testing of an instrument developed by the authors, through an iterative process that included item generation, consensus methods, item appraisal, and cognitive testing. A 46 item questionnaire was tested in 6 sites implementing health related interventions, using paper and online completion. Participants were staff directly involved in working with the interventions. Descriptive analysis and consensus methods were used to remove redundancy, reducing the final tool to 23 items. Data were subject to confirmatory factor analysis which sought to confirm the theoretical structure within the sample.
We obtained 831 completed questionnaires, an average response rate of 39% (range: 22-77%). Full completion of items was 50% (n = 413). The confirmatory factor analysis showed the model achieved acceptable fit (CFI = 0.95, TLI = 0.93, RMSEA = 0.08, SRMR = 0.03). Construct validity of the four theoretical constructs of NPT was supported, and internal consistency (Cronbach's alpha) were as follows: Coherence (4 items, α = 0.71); Collective Action (7 items, α = 0.78); Cognitive Participation (4 items, α = 0.81); Reflexive Monitoring (5 items, α = 0.65). The normalisation scale overall, was highly reliable (20 items, α = 0.89).
The NoMAD instrument has good face validity, construct validity and internal consistency, for assessing staff perceptions of factors relevant to embedding interventions that change their work practices. Uses in evaluating and guiding implementation are proposed.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Falls cause fear, anxiety and loss of confidence, resulting in activity avoidance, social isolation and increasing frailty. The umbrella term for these problems is 'fear of falling', seen in up to ...85% of older adults who fall. Evidence of effectiveness of physical and psychological interventions is limited, with no previous studies examining the role of an individually delivered cognitive-behavioural therapy (CBT) approach.
Primary objective To develop and then determine the effectiveness of a new CBT intervention (CBTi) delivered by health-care assistants (HCAs) plus usual care compared with usual care alone in reducing fear of falling. Secondary objectives To measure the impact of the intervention on falls, injuries, functional abilities, anxiety/depression, quality of life, social participation and loneliness; investigate the acceptability of the intervention for patients, family members and professionals and factors that promote or inhibit its implementation; and measure the costs and benefits of the intervention.
Phase I CBTi development. Phase II Parallel-group patient randomised controlled trial (RCT) of the new CBTi plus usual care compared with usual care alone.
Multidisciplinary falls services.
Consecutive community-dwelling older adults, both sexes, aged ≥ 60 years, with excessive or undue fear of falling per Falls Efficacy Scale-International (FES-I) score of > 23.
Phase I Development of the CBTi. The CBTi was developed following patient interviews and taught to HCAs to maximise the potential for uptake and generalisability to a UK NHS setting. Phase II RCT. The CBTi was delivered by HCAs weekly for 8 weeks, with a 6-month booster session plus usual care.
These were assessed at baseline, 8 weeks, 6 months and 12 months. Primary outcome measure Fear of falling measured by change in FES-I scores at 12 months. Secondary outcome measures These comprised falls, injuries, anxiety/depression Hospital Anxiety and Depression Scale (HADS), quality of life, social participation, loneliness and measures of physical function. There were process and health-economic evaluations alongside the trial.
Four hundred and fifteen patients were recruited, with 210 patients randomised to CBTi group and 205 to the control group. There were significant reductions in mean FES-I -4.02; 95% confidence interval (CI) -5.95 to -2.1, single-item numerical fear of falling scale (-1.42; 95% CI -1.87 to 1.07) and HADS (-1; 95% CI -1.6 to -0.3) scores at 12 months in the CBTi group compared with the usual care group. There were no differences in the other secondary outcome measures. Most patients found the CBTi acceptable. Factors affecting the delivery of the CBTi as part of routine practice were identified. There was no evidence that the intervention was cost-effective.
Our new CBTi delivered by HCAs significantly improved fear of falling and depression scores in older adults who were attending falls services. There was no impact on other measures.
Further work should focus on a joint CBTi and physical training approach to fear of falling, more rational targeting of CBTi, the possibility of mixed group and individual CBTi, and the cost-effectiveness of provision of CBTi by non-specialists.
Current Controlled Trials ISRCTN78396615.
This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 56. See the NIHR Journals Library website for further project information.
Understanding and measuring implementation processes is a key challenge for implementation researchers. This study draws on Normalization Process Theory (NPT) to develop an instrument that can be ...applied to assess, monitor or measure factors likely to affect normalization from the perspective of implementation participants.
An iterative process of instrument development was undertaken using the following methods: theoretical elaboration, item generation and item reduction (team workshops); item appraisal (QAS-99); cognitive testing with complex intervention teams; theory re-validation with NPT experts; and pilot testing of instrument.
We initially generated 112 potential questionnaire items; these were then reduced to 47 through team workshops and item appraisal. No concerns about item wording and construction were raised through the item appraisal process. We undertook three rounds of cognitive interviews with professionals (n = 30) involved in the development, evaluation, delivery or reception of complex interventions. We identified minor issues around wording of some items; universal issues around how to engage with people at different time points in an intervention; and conceptual issues around the types of people for whom the instrument should be designed. We managed these by adding extra items (n = 6) and including a new set of option responses: 'not relevant at this stage', 'not relevant to my role' and 'not relevant to this intervention' and decided to design an instrument explicitly for those people either delivering or receiving an intervention. This version of the instrument had 53 items. Twenty-three people with a good working knowledge of NPT reviewed the items for theoretical drift. Items that displayed a poor alignment with NPT sub-constructs were removed (n = 8) and others revised or combined (n = 6). The final instrument, with 43 items, was successfully piloted with five people, with a 100% completion rate of items.
The process of moving through cycles of theoretical translation, item generation, cognitive testing, and theoretical (re)validation was essential for maintaining a balance between the theoretical integrity of the NPT concepts and the ease with which intended respondents could answer the questions. The final instrument could be easily understood and completed, while retaining theoretical validity. NoMAD represents a measure that can be used to understand implementation participants' experiences. It is intended as a measure that can be used alongside instruments that measure other dimensions of implementation activity, such as implementation fidelity, adoption, and readiness.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Maternal weight management is a priority due to pregnancy risks for women and babies. Interventions significantly improve maternal diet, physical activity, weight, and pregnancy outcomes. There are ...complex barriers to midwives' implementation of guidelines; low self-efficacy is a core implementation barrier. The GLOWING intervention uses social cognitive theory (SCT) to address evidence-based barriers to practice. The intervention aimed to support midwives' implementation of guidelines.
An external rehearsal pilot cluster randomised controlled trial in four NHS Trusts (clusters) in England, UK. Clusters were randomised to intervention (where all eligible midwives received the intervention) or control (no intervention delivered) arms. A random sample of 100 midwives were invited to complete questionnaires pre- and post-intervention. UK guideline recommendations relating to midwives' practice were categorised into: 1) communication-related behaviours (including weight- and risk-communication), and 2) support/intervention-related behaviours (including diet/nutrition, physical activity, weight management, referrals/signposting). Questionnaires were developed using SCT constructs (self-efficacy, outcome expectancies, intentions, behaviours) and 7-point Likert scale, converted to a 0-100 scale. Higher scores were more positive. Descriptive statistics compared intervention and control arms, pre- and post-intervention.
Seventy-four midwives consented and 68 returned questionnaires. Pre-intervention, self-efficacy for support/intervention-related behaviours scored lowest. In controls, there was limited difference between the pre- and post-intervention scores. Post-intervention, mean (SD) scores were consistently higher among intervention midwives than controls, particularly for support/intervention self-efficacy (71.4 (17.1) vs. 58.4 (20.1)). Mean (SD) self-efficacy was higher post-intervention than pre-intervention for all outcomes among intervention midwives, and consistently higher than controls. Mean differences pre- and post-intervention were greatest for support/intervention self-efficacy (17.92, 95% CI 7.78-28.07) and intentions (12.68, 95% CI 2.76-22.59). Self-efficacy was particularly increased for diet/nutrition and physical activity (MD 24.77, 95% CI 14.09-35.44) and weight management (18.88, 95% CI 7.88-29.88) behaviours, which showed the largest increase in scores.
This study supports the theoretical models used to develop GLOWING, where low self-efficacy was a core implementation barrier. Results suggest that GLOWING successfully targets self-efficacy, potentially with a positive impact on guideline implementation. A definitive trial is required to determine effectiveness.
ISRCTN46869894, retrospectively registered 25/05/2016, http://isrctn.com/ISRCTN46869894.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
In the UK, there are currently 800 000 people living with dementia. This number is expected to double in the next 20 years. Two-thirds of people with dementia live in the community supported by ...informal carers. Caring for a person with dementia has adverse effects on psychological, physical, social wellbeing and quality of life. The measurement of quality of life of carers of people with dementia is increasingly of interest to health and social care practitioners and commissioners, policymakers, and carers themselves. However, there is lack of consensus on the most suitable instrument(s) for undertaking this.
A systematic review of the literature using COSMIN methodology. Searching of electronic databases (Medline, PsycINFO, CINAHL and Web of Science), reference list and citation searching of key papers was undertaken. COSMIN methodology was used to simultaneously extract data from and assess methodological quality of included studies, and make a recommendation for the instrument with the most high quality evidence for its measurement properties.
Ten instruments were suitable for inclusion in this review. The Carer well-being and support questionnaire (CWS) has the best quality evidence for the greatest number of measurement of properties. The Caregiver Well-Being Scale is also worthy of consideration. There is not presently a measure which could be recommended for use in economic evaluations, however the Impact of Alzheimer's Disease on the Caregiver questionnaire (IADCQ) could potentially be used following further investigation of its measurement properties in a representative population.
The CWS is the most appropriate instrument to recommend for the assessment of quality of life in informal carers of people with dementia at present. All instruments included in this review would benefit from more rigorous evaluation of their measurement properties.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Context
Pre‐appointment written materials, including letters and leaflets, are commonly used by healthcare organisations to deliver professional‐patient interactions. The written materials ...potentially change patients’ knowledge and behaviour as part of a healthcare intervention but have received little investigation.
Objective
To describe the content of pre‐appointment written materials through a behaviour change intervention perspective.
Design
Mixed methods study with an online questionnaire about pre‐appointment written materials and an analysis of actual materials. Questionnaire data were analysed descriptively and pre‐appointment materials by qualitative framework analysis.
Setting and participants
Children's community/outpatient occupational therapy, physiotherapy and/or speech and language therapy services across the UK. Service managers/clinical leads provided data.
Intervention
Pre‐appointment written materials.
Results
Questionnaire responses were received from n = 110 managers/clinical leads from n = 58 NHS organisations. Written materials (n = 64) were received from n = 24 organisations. Current materials are used by therapy services as a conduit to convey the therapy service's expectations related to: accessing the service, decision‐making about care and help‐giving. The materials enrol the parent and child to the therapy services’ expectations by behaviour change techniques. The materials configure the parent/child expectations, knowledge and behaviour towards the therapy services’ operational procedures.
Conclusion
Pre‐appointment written materials configure patients to organisations’ operational procedures. The written materials currently lack support for parent/child empowerment, shared decision‐making and self‐management to improve health.
Patient Contribution
Four parents of children accessing therapy services were involved in the study. The parents shared their experiences to highlight the importance of the topic and contributed to the final research design and methods.
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BFBNIB, DOBA, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, SIK, UILJ, UKNU, UL, UM, UPUK, VSZLJ
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