Feasibility and acceptability of offering breast cancer risk assessment to general population women aged 30-39 years: a mixed-methods study protocol.

INTRODUCTION: Breast cancer incidence starts to increase exponentially when women reach 30-39 years, hence before they are eligible for breast cancer screening. The introduction of breast cancer risk assessment for this age group could lead to those at higher risk receiving benefits of earlier screening and preventive strategies. Currently, risk assessment is limited to women with a family history of breast cancer only. The Breast CANcer Risk Assessment in Younger women (BCAN-RAY) study is evaluating a comprehensive breast cancer risk assessment strategy for women aged 30-39 years incorporating a questionnaire of breast cancer risk factors, low-dose mammography to assess breast density and polygenic risk. This study will assess the feasibility and acceptability of the BCAN-RAY risk assessment strategy. METHODS AND ANALYSIS: This study involves women undergoing risk assessment as part of the BCAN-RAY case-control study (n=750). They will be aged 30-39 years without a strong family history of breast cancer and invited to participate via general practice. A comparison of uptake rates by socioeconomic status and ethnicity between women who participated in the BCAN-RAY study and women who declined participation will be conducted. All participants will be asked to complete self-report questionnaires to assess key potential harms including increased state anxiety (State Trait Anxiety Inventory), cancer worry (Lerman Cancer Worry Scale) and satisfaction with the decision to participate (Decision Regret Scale), alongside potential benefits such as feeling more informed about breast cancer risk. A subsample of approximately 24 women (12 at average risk and 12 at increased risk) will additionally participate in semistructured interviews to understand the acceptability of the risk assessment strategy and identify any changes needed to it to increase uptake. ETHICS AND DISSEMINATION: Ethical approval was granted by North West-Greater Manchester West Research Ethics Committee (reference: 22/NW/0268). Study results will be disseminated through peer-reviewed journals, conference presentations and charitable organisations. TRIAL REGISTRATION NUMBER: NCT05305963.

Description of the nationally implemented National Health Service digital diabetes prevention programme and rationale for its development: mixed methods study.

BACKGROUND: The National Health Service (NHS) Digital Diabetes Prevention Programme (DDPP) is a behaviour change programme for adults in England who are at high risk of developing type 2 diabetes. Four independent providers deliver the NHS-DDPP following a competitive tendering process. Although providers work to a single service specification, there is potential for some variation in the service across providers. This study (1) assesses fidelity of the structural features of the design of the NHS-DDPP compared to the service specification, (2) describes the structural features of delivery of the NHS-DDPP as implemented (3) reports developers' views on how the structural components of the NHS-DDPP were developed and why changes were made following implementation. METHODS: Using mixed methods, we conducted a document review of providers' NHS-DDPP design and delivery documentation, and extracted information using the Template for Intervention Description and Replication checklist, which was adapted to capture features of digital delivery. Documentation was supplemented by content analysis of interviews with 12 health coaches involved in delivering the NHS-DDPP. Semi-structured interviews were also conducted with 6 programme developers employed by the digital providers. RESULTS: Provider plans for the NHS-DDPP show relatively high fidelity to the NHS service specification. Despite this, there was wide variation in structural features of delivery of the NHS-DDPP across providers, particularly for delivery of 'support' (e.g. use, dose and scheduling of health coaching and/or group support). Interviews with developers of the programmes showed that much of this variation is likely to be attributable to the origin of each provider's programme, which was usually a pre-existing programme that was adapted to conform to the NHS-DDPP service specification. The NHS-DDPP is continually improved and developed based on user experience feedback and research conducted by the providers. CONCLUSION: Indirect evidence suggests that variation in delivery of support could affect effectiveness of the NHS-DDPP. A priority for future research is ascertaining whether the variation in delivery of the NHS-DDPP across providers is related to any differences in health outcomes. It is recommended that future rounds of commissioning the NHS-DDPP pre-specify the type of support participants should receive, including expected dose and scheduling.

Optimising the delivery of breast cancer risk assessment for women aged 30-39 years: A qualitative study of women's views.

BACKGROUND: Identifying women aged 30-39 years at increased risk of developing breast cancer could allow them to consider screening and preventive strategies. Research is underway to determine the feasibility of offering breast cancer risk assessment to this age group. However, it is unclear how best to deliver and communicate risk estimates to these women, in order to avoid potential harms such as undue anxiety and increase benefits such as informed decision-making. OBJECTIVES: This study aimed to investigate women's views on, and requirements for, this proposed novel approach to risk assessment. DESIGN: A cross-sectional qualitative design was used. METHODS: Thirty-seven women aged 30-39 years with no family history or personal history of breast cancer participated in seven focus groups (n = 29) and eight individual interviews. Data were analysed thematically using a framework approach. RESULTS: Four themes were developed. Acceptability of risk assessment service concerns the positive views women have towards the prospect of participating in breast cancer risk assessment. Promoting engagement with the service describes the difficulties women in this age group experience in relation to healthcare access, including mental load and a lack of cultural awareness, and the implications of this for service design and delivery. Impact of receiving risk results focuses on the anticipated impacts of receiving different risk outcomes, namely, complacency towards breast awareness behaviours following low-risk results, an absence of reassurance following average-risk results and anxiety for high-risk results. Women's information requirements highlights women's desire to be fully informed at invite including understanding why the service is needed. In addition, women wanted risk feedback to focus on plans for management. CONCLUSION: The idea of breast cancer risk assessment was received favourably among this age group, providing that a risk management plan and support from healthcare professionals is available. Determinants of acceptability of a new service included minimising effort required to engage with service, co-development of invitation and risk feedback materials and the importance of educational campaigning about the potential benefits of participation in risk assessment.

Proactive breast cancer risk assessment in primary care: a review based on the principles of screening.

In the UK, the National Institute for Health and Care Excellence (NICE) recommends that women at moderate or high risk of breast cancer be offered risk-reducing medication and enhanced breast screening/surveillance. In June 2022, NICE withdrew a statement recommending assessment of risk in primary care only when women present with concerns. This shift to the proactive assessment of risk substantially changes the role of primary care, in effect paving the way for a primary care-based screening programme to identify those at moderate or high risk of breast cancer. In this article, we review the literature surrounding proactive breast cancer risk assessment within primary care against the consolidated framework for screening. We find that risk assessment for women under 50 years currently satisfies many of the standard principles for screening. Most notably, there are large numbers of women at moderate or high risk currently unidentified, risk models exist that can identify those women with reasonable accuracy, and management options offer the opportunity to reduce breast cancer incidence and mortality in that group. However, there remain a number of uncertainties and research gaps, particularly around the programme/system requirements, that need to be addressed before these benefits can be realised.

How the Behavior Change Content of a Nationally Implemented Digital Diabetes Prevention Program Is Understood and Used by Participants: Qualitative Study of Fidelity of Receipt and Enactment.

BACKGROUND: The National Health Service Digital Diabetes Prevention Programme (NHS-DDPP) is a program for adults in England at risk of developing type 2 diabetes mellitus (T2DM). It is based on NHS England specifications that stipulate specific behavior change techniques (BCTs), that is, active ingredients to produce behavior change to target diet and physical activity. Now rolled out nationally, the NHS-DDPP is being delivered by 4 independent providers as a 9-month intervention via apps, educational material, and remote health coaching. To optimize effectiveness, participants need to be able to understand and use behavior change content (eg, goal setting and problem solving) of an intervention delivered to them digitally. Previous research has shown that people benefit from support to aid the understanding and use of BCTs. OBJECTIVE: The objectives of this qualitative study were to evaluate how participants in the NHS-DDPP understand and use BCT content, investigate how participants describe the role of health coaches in supporting their behavior change, and examine how the understanding and use of behavior change content of the NHS-DDPP varies across providers. METHODS: In total, 45 service users were interviewed twice by telephone at 2 to 4 months into, and at the end of, the program. Topics included participants' understanding and use of key BCTs to support self-regulation (eg, goal setting) and the support they received via the program. Transcripts were analyzed thematically, informed by the framework method. RESULTS: Participants described their understanding and use of some behavior change content of the program as straightforward: use of BCTs (eg, self-monitoring of behavior) delivered digitally via provider apps. Participants valued the role of health coaches in supporting their behavior change through the emotional support they offered and their direct role in delivery and application of some BCTs (eg, problem solving) to their specific circumstances. Participants expressed frustration over the lack of monitoring or feedback regarding their T2DM risk within the program. Variations in the understanding and use of behavior change content of the NHS-DDPP were present across provider programs. CONCLUSIONS: Health coaches' support in delivery of key components of the program seems to be pivotal. To improve the understanding and use of BCTs in digital interventions, it is important to consider routes of delivery that offer additional interactive human support. Understanding of some self-regulatory BCTs may benefit from this support more than others; thus, identifying the optimal mode of delivery for behavior change content is a priority for future research. The NHS-DDPP could be improved by explicitly setting out the need for health coaches to support understanding of some self-regulatory BCT content such as problem solving in the service specification and amending the discharge process so that knowledge of any change in T2DM risk is available to participants.

Implementing Risk-Stratified Breast Screening in England: An Agenda Setting Meeting.

It is now possible to accurately assess breast cancer risk at routine NHS Breast Screening Programme (NHSBSP) appointments, provide risk feedback and offer risk management strategies to women at higher risk. These strategies include National Institute for Health and Care Excellence (NICE) approved additional breast screening and risk-reducing medication. However, the NHSBSP invites nearly all women three-yearly, regardless of risk. In March 2022, a one-day agenda setting meeting took place in Manchester to discuss the feasibility and desirability of implementation of risk-stratified screening in the NHSBSP. Fifty-eight individuals participated (38 face-to-face, 20 virtual) with relevant expertise from academic, clinical and/or policy-making perspectives. Key findings were presented from the PROCAS2 NIHR programme grant regarding feasibility of risk-stratified screening in the NHSBSP. Participants discussed key uncertainties in seven groups, followed by a plenary session. Discussions were audio-recorded and thematically analysed to produce descriptive themes. Five themes were developed: (i) risk and health economic modelling; (ii) health inequalities and communication with women; (iii); extending screening intervals for low-risk women; (iv) integration with existing NHSBSP; and (v) potential new service models. Most attendees expected some form of risk-stratified breast screening to be implemented in England and collectively identified key issues to be resolved to facilitate this.

Study protocol comparing the ethical, psychological and socio-economic impact of personalised breast cancer screening to that of standard screening in the "My Personal Breast Screening" (MyPeBS) randomised clinical trial.

BACKGROUND: The MyPeBS study is an ongoing randomised controlled trial testing whether a risk-stratified breast cancer screening strategy is non-inferior, or eventually superior, to standard age-based screening at reducing incidence of stage 2 or more cancers. This large European Commission-funded initiative aims to include 85,000 women aged 40 to 70 years, without prior breast cancer and not previously identified at high risk in six countries (Belgium, France, Italy, Israel, Spain, UK). A specific work package within MyPeBS examines psychological, socio-economic and ethical aspects of this new screening strategy. It compares women's reported data and outcomes in both trial arms on the following issues: general anxiety, cancer-related worry, understanding of breast cancer screening strategy and information-seeking behaviour, socio-demographic and economic characteristics, quality of life, risk perception, intention to change health-related behaviours, satisfaction with the trial. METHODS: At inclusion, 3-months, 1-year and 4-years, each woman participating in MyPeBS is asked to fill online questionnaires. Descriptive statistics, bivariate analyses, subgroup comparisons and analysis of variations over time will be performed with appropriate tests to assess differences between arms. Multivariate regression models will allow modelling of different patient reported data and outcomes such as comprehension of the information provided, general anxiety or cancer worry, and information seeking behaviour. In addition, a qualitative study (48 semi-structured interviews conducted in France and in the UK with women randomised in the risk-stratified arm), will help further understand participants' acceptability and comprehension of the trial, and their experience of risk assessment. DISCUSSION: Beyond the scientific and medical objectives of this clinical study, it is critical to acknowledge the consequences of such a paradigm shift for women. Indeed, introducing a risk-based screening relying on individual biological differences also implies addressing non-biological differences (e.g. social status or health literacy) from an ethical perspective, to ensure equal access to healthcare. The results of the present study will facilitate making recommendations on implementation at the end of the trial to accompany any potential change in screening strategy. TRIAL REGISTRATION: Study sponsor: UNICANCER. My personalised breast screening (MyPeBS). CLINICALTRIALS: gov (2018) available at: https://clinicaltrials.gov/ct2/show/NCT03672331 Contact: Cécile VISSAC SABATIER, PhD, + 33 (0)1 73 79 77 58 ext + 330,142,114,293, contact@mypebs.eu.

The Acceptability of Physical Activity to Older Adults Living in Lower Socioeconomic Status Areas: A Multi-Perspective Study.

Older adults in lower socioeconomic status (SES) areas are the least active of all adult groups but are often absent from physical activity research. The present study aimed to elicit perspectives on acceptability of physical activity from older adults and physical activity providers in lower SES areas. Semi-structured interviews were conducted with 19 older adults and eight physical activity trainers/providers in lower SES areas. An inductive, multi-perspective Thematic Analysis was conducted. Eight themes were identified that covered one or both groups' perceptions of what was important in ensuring acceptability of activity provision. Older adults perceived a lack of value that was reinforced by lack of resources and unequal provision. Acceptability was hindered by centralisation of facilities and lack of understanding of needs by facility management. Facilitating social interaction within physical activities appeared key, thereby meeting multiple needs with fewer resources. In conclusion, to increase acceptability of physical activity for older adults in low SES areas, providers should address the lack of perceived value felt by many older adults. Equitable provision of physical activities addressing multiple needs may allow older adults with limited resources to be physically active without sacrificing other needs. Facilitating creation of social bonds may foster maintenance of physical activities.

Reducing bias in trials from reactions to measurement: the MERIT study including developmental work and expert workshop.

BACKGROUND: Measurement can affect the people being measured; for example, asking people to complete a questionnaire can result in changes in behaviour (the 'question-behaviour effect'). The usual methods of conduct and analysis of randomised controlled trials implicitly assume that the taking of measurements has no effect on research participants. Changes in measured behaviour and other outcomes due to measurement reactivity may therefore introduce bias in otherwise well-conducted randomised controlled trials, yielding incorrect estimates of intervention effects, including underestimates. OBJECTIVES: The main objectives were (1) to promote awareness of how and where taking measurements can lead to bias and (2) to provide recommendations on how best to avoid or minimise bias due to measurement reactivity in randomised controlled trials of interventions to improve health. METHODS: We conducted (1) a series of systematic and rapid reviews, (2) a Delphi study and (3) an expert workshop. A protocol paper was published [Miles LM, Elbourne D, Farmer A, Gulliford M, Locock L, McCambridge J, et al. Bias due to MEasurement Reactions In Trials to improve health (MERIT): protocol for research to develop MRC guidance. Trials 2018;19:653]. An updated systematic review examined whether or not measuring participants had an effect on participants' health-related behaviours relative to no-measurement controls. Three new rapid systematic reviews were conducted to identify (1) existing guidance on measurement reactivity, (2) existing systematic reviews of studies that have quantified the effects of measurement on outcomes relating to behaviour and affective outcomes and (3) experimental studies that have investigated the effects of exposure to objective measurements of behaviour on health-related behaviour. The views of 40 experts defined the scope of the recommendations in two waves of data collection during the Delphi procedure. A workshop aimed to produce a set of recommendations that were formed in discussion in groups. RESULTS: Systematic reviews - we identified a total of 43 studies that compared interview or questionnaire measurement with no measurement and these had an overall small effect (standardised mean difference 0.06, 95% confidence interval 0.02 to 0.09; n = 104,096, I2 = 54%). The three rapid systematic reviews identified no existing guidance on measurement reactivity, but we did identify five systematic reviews that quantified the effects of measurement on outcomes (all focused on the question-behaviour effect, with all standardised mean differences in the range of 0.09-0.28) and 16 studies that examined reactive effects of objective measurement of behaviour, with most evidence of reactivity of small effect and short duration. Delphi procedure - substantial agreement was reached on the scope of the present recommendations. Workshop - 14 recommendations and three main aims were produced. The aims were to identify whether or not bias is likely to be a problem for a trial, to decide whether or not to collect further quantitative or qualitative data to inform decisions about if bias is likely to be a problem, and to identify how to design trials to minimise the likelihood of this bias. LIMITATION: The main limitation was the shortage of high-quality evidence regarding the extent of measurement reactivity, with some notable exceptions, and the circumstances that are likely to bring it about. CONCLUSION: We hope that these recommendations will be used to develop new trials that are less likely to be at risk of bias. FUTURE WORK: The greatest need is to increase the number of high-quality primary studies regarding the extent of measurement reactivity. STUDY REGISTRATION: The first systematic review in this study is registered as PROSPERO CRD42018102511. FUNDING: Funded by the Medical Research Council UK and the National Institute for Health Research as part of the Medical Research Council-National Institute for Health Research Methodology Research Programme.

When people are asked to complete measures such as questionnaires in research studies this can produce changes in the behaviour or emotions of those people. For example, people who are asked to complete questionnaires about drinking alcohol have been found to drink slightly less, on average, than people who are not asked to complete questionnaires. Current established methods of research usually ignore these reactions to measurement. The present research aimed to produce recommendations for how best to deal with reactions to measurement. The scope of these recommendations was limited to 'trials' used to test whether or not a treatment improves health. To do this, we identified relevant research studies that have investigated various different aspects of whether or not measurement affects the people being measured. We then consulted 40 experts about what the current recommendations should consider and what was not within the scope of the current recommendations. We then gathered 23 experts together for 2 days to produce a set of recommendations. We found 43 research studies that have looked at whether or not being asked to complete questionnaires or being interviewed affects the behaviour of those people invited. In general, there were some effects of completing questionnaires, but the effects were not very consistent across research studies. There were few studies that have looked at the effects of using measures of behaviour other than questionnaires (e.g. blood pressure cuffs). We could find no existing recommendations for how best to deal with reactions to measurement in research studies that examine whether or not treatments improve health. We have produced 14 recommendations for researchers to better take account of the issue of measuring affecting the people being measured. We hope that this will help future research produce more accurate answers. We also identified that there is a need for more studies of the effects of measures other than questionnaires.

Breast Cancer Risk Assessment and Primary Prevention Advice in Primary Care: A Systematic Review of Provider Attitudes and Routine Behaviours.

Implementing risk-stratified breast cancer screening is being considered internationally. It has been suggested that primary care will need to take a role in delivering this service, including risk assessment and provision of primary prevention advice. This systematic review aimed to assess the acceptability of these tasks to primary care providers. Five databases were searched up to July-August 2020, yielding 29 eligible studies, of which 27 were narratively synthesised. The review was pre-registered (PROSPERO: CRD42020197676). Primary care providers report frequently collecting breast cancer family history information, but rarely using quantitative tools integrating additional risk factors. Primary care providers reported high levels of discomfort and low confidence with respect to risk-reducing medications although very few reported doubts about the evidence base underpinning their use. Insufficient education/training and perceived discomfort conducting both tasks were notable barriers. Primary care providers are more likely to accept an increased role in breast cancer risk assessment than advising on risk-reducing medications. To realise the benefits of risk-based screening and prevention at a population level, primary care will need to proactively assess breast cancer risk and advise on risk-reducing medications. To facilitate this, adaptations to infrastructure such as integrated tools are necessary in addition to provision of education.

The theoretical basis of a nationally implemented type 2 diabetes prevention programme: how is the programme expected to produce changes in behaviour?

BACKGROUND: It is considered best practice to provide clear theoretical descriptions of how behaviour change interventions should produce changes in behaviour. Commissioners of the National Health Service Diabetes Prevention Programme (NHS-DPP) specified that the four independent provider organisations must explicitly describe the behaviour change theory underpinning their interventions. The nationally implemented programme, launched in 2016, aims to prevent progression to Type 2 diabetes in high-risk adults through changing diet and physical activity behaviours. This study aimed to: (a) develop a logic model describing how the NHS-DPP is expected to work, and (b) document the behaviour change theories underpinning providers' NHS-DPP interventions. METHODS: A logic model detailing how the programme should work in changing diet and activity behaviours was extracted from information in three specification documents underpinning the NHS-DPP. To establish how each of the four providers expected their interventions to produce behavioural changes, information was extracted from their programme plans, staff training materials, and audio-recorded observations of mandatory staff training courses attended in 2018. All materials were coded using Michie and Prestwich's Theory Coding Scheme. RESULTS: The NHS-DPP logic model included information provision to lead to behaviour change intentions, followed by a self-regulatory cycle including action planning and monitoring behaviour. None of the providers described an explicit logic model of how their programme will produce behavioural changes. Two providers stated their programmes were informed by the COM-B (Capability Opportunity Motivation - Behaviour) framework, the other two described targeting factors from multiple theories such as Self-Regulation Theory and Self-Determination Theory. All providers cited examples of proposed links between some theoretical constructs and behaviour change techniques (BCTs), but none linked all BCTs to specified constructs. Some discrepancies were noted between the theory described in providers' programme plans and theory described in staff training. CONCLUSIONS: A variety of behaviour change theories were used by each provider. This may explain the variation between providers in BCTs selected in intervention design, and the mismatch between theory described in providers' programme plans and staff training. Without a logic model describing how they expect their interventions to work, justification for intervention contents in providers' programmes is not clear.

What are the benefits and harms of risk stratified screening as part of the NHS breast screening Programme? Study protocol for a multi-site non-randomised comparison of BC-predict versus usual screening (NCT04359420).

BACKGROUND: In principle, risk-stratification as a routine part of the NHS Breast Screening Programme (NHSBSP) should produce a better balance of benefits and harms. The main benefit is the offer of NICE-approved more frequent screening and/ or chemoprevention for women who are at increased risk, but are unaware of this. We have developed BC-Predict, to be offered to women when invited to NHSBSP which collects information on risk factors (self-reported information on family history and hormone-related factors via questionnaire; mammographic density; and in a sub-sample, Single Nucleotide Polymorphisms). BC-Predict produces risk feedback letters, inviting women at high risk (≥8% 10-year) or moderate risk (≥5 to < 8% 10-year) to have discussion of prevention and early detection options at Family History, Risk and Prevention Clinics. Despite the promise of systems such as BC-Predict, there are still too many uncertainties for a fully-powered definitive trial to be appropriate or ethical. The present research aims to identify these key uncertainties regarding the feasibility of integrating BC-Predict into the NHSBSP. Key objectives of the present research are to quantify important potential benefits and harms, and identify key drivers of the relative cost-effectiveness of embedding BC-Predict into NHSBSP. METHODS: A non-randomised fully counterbalanced study design will be used, to include approximately equal numbers of women offered NHSBSP (n = 18,700) and BC-Predict (n = 18,700) from selected screening sites (n = 7). In the initial 8-month time period, women eligible for NHSBSP will be offered BC-Predict in four screening sites. Three screening sites will offer women usual NHSBSP. In the following 8-months the study sites offering usual NHSBSP switch to BC-Predict and vice versa. Key potential benefits including uptake of risk consultations, chemoprevention and additional screening will be obtained for both groups. Key potential harms such as increased anxiety will be obtained via self-report questionnaires, with embedded qualitative process analysis. A decision-analytic model-based cost-effectiveness analysis will identify the key uncertainties underpinning the relative cost-effectiveness of embedding BC-Predict into NHSBSP. DISCUSSION: We will assess the feasibility of integrating BC-Predict into the NHSBSP, and identify the main uncertainties for a definitive evaluation of the clinical and cost-effectiveness of BC-Predict. TRIAL REGISTRATION: Retrospectively registered with clinicaltrials.gov (NCT04359420).

Mechanisms of physical activity behavior change in an incentive-based intervention: Mediation analysis.

OBJECTIVE: The physical activity loyalty (PAL) scheme was a cluster randomized controlled trial of a 6-month complex intervention targeting workplace physical activity. Financial incentives were incorporated in an evidence-based behavior change program, including self-regulation techniques. This article examines short-term (< 6 months) and long-term (≥ 6 months) mediation effects on physical activity. METHOD: Participants included 853 adults (457 intervention, 396 control). Physical activity was objectively assessed using pedometers at baseline and at 6 and 12 months. Hypothesized short-term mediators (e.g., self-efficacy, intentions) were assessed at baseline and 4 weeks. Hypothesized long-term mediators (e.g., habit, intrinsic motivation) were assessed at baseline and 6 months. Mediation models employed the structural equation modeling product-of-coefficients approach. RESULTS: Intervention participants experienced significant decreases in 6-month pedometer steps/day versus controls (b = -336, p = .02), which were partially mitigated by positive indirect effects through 6-month integrated regulation (ab = 94.7, 95% CI [18.7, 204.4]), intrinsic motivation (ab = 59.0, 95% CI [3.09, 154.5]), and habit (ab = 198.7, 95% CI [84.3, 369.9]). There were no between-groups differences in 12-month pedometer steps/day but positive indirect effects through 6-month integrated regulation (ab = 128.0, 95% CI [27.3, 313.2]), planning (ab = 115.0, 95% CI [3.71, 285.5]), and habit (ab = 153.3, 95% CI [39.3, 333.1]). CONCLUSIONS: Most examined mediators were nonsignificant, and mediation analyses did not explain decreases in physical activity for interventions versus controls. Results show that, contrary to self-determination theory hypotheses, intrinsic motivation is not necessarily adversely impacted if financial incentives are embedded in a complex intervention. (PsycINFO Database Record (c) 2020 APA, all rights reserved).

Engagement barriers and service inequities in the NHS Breast Screening Programme: Views from British-Pakistani women.

OBJECTIVES: Previous research has largely attempted to explore breast screening experiences of South Asian women by combining opinions from Pakistani, Bangladeshi, and Indian women. This research often fails to reach the most underserved sub-groups of this population, with socioeconomic status not routinely reported, and English fluency being a participation requirement. With uptake low amongst British-Pakistani women, this study explores the experiences these women encounter when accessing the NHS Breast Screening Programme. METHODS: 19 one-to-one semi-structured interviews were carried out with British-Pakistani women from East Lancashire, UK. 14 interviews were conducted via an interpreter. RESULTS: Data were analysed using thematic analysis. Three themes were identified: 'Absence of autonomy in screening and healthcare access' describes how currently the screening service does not facilitate confidentiality or independence. Access requires third-party intervention, with language barriers preventing self-expression. 'Appraisal of information sources' makes distinctions between community and NHS communication. Whereas community communication was invaluable, NHS materials were deemed inaccessible due to translation incongruences and incomprehensible terminology. 'Personal suppositions of breast screening' explores the subjective issues associated with disengagement, including, the cultural misalignment of the service, and perceiving screening as a symptomatic service. CONCLUSIONS: British-Pakistani women face some unique challenges when accessing breast screening. To promote uptake, the service needs to address the translation of screening materials and optimize upon community networks to disseminate knowledge, including knowledge of the screening environment within the context of culture to promote informed choice about attendance.

Translating a walking intervention for health professional delivery within primary care: A mixed-methods treatment fidelity assessment.

OBJECTIVES: Existing fidelity studies of physical activity interventions are limited in methodological quality and rigour, particularly those delivered by health care providers in clinical settings. The present study aimed to enhance and assess the fidelity of a walking intervention delivered by health care providers within general practice in line with the NIH Behavior Change Consortium treatment fidelity framework. DESIGN: Two practice nurses and six health care assistants delivered a theory-based walking intervention to 63 patients in their own practices. A cross-sectional mixed-methods study assessed fidelity related to treatment delivery and treatment receipt, from the perspectives of health care providers and patients. METHODS: All providers received training and demonstrated delivery competence prior to the trial. Delivery of intervention content was coded from audio-recordings using a standardized checklist. Qualitative interviews with 12 patients were conducted to assess patient perspectives of treatment receipt and analysed using framework analysis. RESULTS: Overall, 78% of intervention components were delivered as per the protocol (range 36-91%), with greater fidelity for components requiring active engagement from patients (e.g., completion of worksheets). The qualitative data highlighted differences in patients' comprehension of specific intervention components. Understanding of, and engagement with, motivational components aimed at improving self-efficacy was poorer than for volitional planning components. CONCLUSIONS: High levels of fidelity of delivery were demonstrated. However, patient-, provider-, and component-level factors impacted on treatment delivery and receipt. We recommend that methods for the enhancement and assessment of treatment fidelity are consistently implemented to enhance the rigour of physical activity intervention research. Statement of contribution What is already known on this subject? Physical activity interventions delivered within primary care by health professionals have so far demonstrated limited impact on behaviour change initiation and maintenance. Treatment fidelity enhancement and assessment strategies can support the successful translation of behaviour change interventions into real-life settings. Few studies have examined treatment fidelity within the context of physical activity interventions, particularly within clinical settings, and existing fidelity studies are limited by methodological quality and rigour. What does this study add? High levels of fidelity were found for a physical activity intervention delivered in primary care. Patient-, provider-, and component-level factors may impact on treatment delivery and receipt. The implementation of best practice fidelity recommendations can support near-optimal fidelity.

Predicting Outcomes from Engagement With Specific Components of an Internet-Based Physical Activity Intervention With Financial Incentives: Process Analysis of a Cluster Randomized Controlled Trial.

BACKGROUND: Investigating participant engagement and nonusage attrition can help identify the likely active ingredients of electronic health interventions. Research on engagement can identify which intervention components predict health outcomes. Research on nonusage attrition is important to make recommendations for retaining participants in future studies. OBJECTIVE: This study aimed to investigate engagement and nonusage attrition in the Physical Activity Loyalty (PAL) scheme, a 6-month complex physical activity intervention in workplaces in Northern Ireland. The intervention included financial incentives with reward redemption and self-regulation techniques. Specific objectives were (1) to determine whether engagement in specific intervention components predicted physical activity at 6 months, (2) to determine whether engagement in specific intervention components predicted targeted mediators at 6 months, and (3) to investigate predictors of nonusage attrition for participants recording daily activity via the PAL scheme physical activity monitoring system and logging onto the website. METHODS: Physical activity was assessed at baseline and 6 months using pedometers (Yamax Digiwalker CW-701, Japan). Markers of engagement and website use, monitoring system use, and reward redemption were collected throughout the scheme. Random-effects generalized least-squares regressions determined whether engagement with specific intervention components predicted 6-month physical activity and mediators. Cox proportional hazards regressions were used to investigate predictors of nonusage attrition (days until first 2-week lapse). RESULTS: A multivariable generalized least-squares regression model (n=230) showed that the frequency of hits on the website's monitoring and feedback component (regression coefficient [b]=50.2; SE=24.5; P=.04) and the percentage of earned points redeemed for financial incentives (b=9.1; SE=3.3; P=.005) were positively related to 6-month pedometer steps per day. The frequency of hits on the discussion forum (b=-69.3; SE=26.6; P=.009) was negatively related to 6-month pedometer steps per day. Reward redemption was not related to levels of more internal forms of motivation. Multivariable Cox proportional hazards regression models identified several baseline predictors associated with nonusage attrition. These included identified regulation (hazard ratio [HR] 0.88, 95% CI 0.81-0.97), recovery self-efficacy (HR 0.88, 95% CI 0.80-0.98), and perceived workplace environment safety (HR 1.07, 95% CI 1.02-1.11) for using the physical activity monitoring system. The EuroQoL health index (HR 0.33, 95% CI 0.12-0.91), financial motivation (HR 0.93, 95% CI 0.87-0.99), and perceived availability of physical activity opportunities in the workplace environment (HR 0.96, 95% CI 0.93-0.99) were associated with website nonusage attrition. CONCLUSIONS: Our results provide evidence opposing one of the main hypotheses of self-determination theory by showing that financial rewards are not necessarily associated with decreases in more internal forms of motivation when offered as part of a complex multicomponent intervention. Identifying baseline predictors of nonusage attrition can help researchers to develop strategies to ensure maximum intervention adherence. TRIAL REGISTRATION: ISRCTN Registry ISRCTN17975376; http://www.isrctn.com/ISRCTN17975376 (Archived by WebCite at http://www.webcitation.org/76VGZsZug).

How Acceptable is Reducing Sedentary Behavior to Older Adults? Perceptions and Experiences Across Diverse Socioeconomic Areas.

Sedentary behavior is associated with negative health outcomes, and older adults represent the most sedentary age group. There is currently little qualitative evidence to inform the development of sedentary behavior interventions targeting older adults. This study explored factors affecting older adults' sedentary behaviors and the acceptability of potential strategies to reduce sedentary time. Semistructured interviews with 22 older adults with diverse socioeconomic backgrounds in Manchester, England were conducted. An inductive thematic analysis was structured using the framework approach. Limited availability of community resources was identified in deprived areas. Local environments impacted sedentary behavior, including sense of community belonging, crime, and physical infrastructure. Enjoyment, socializing, and feeling a sense of achievement were key motivations to engage in nonsedentary activities. As older adults desire social interaction and enjoyment, community interventions in urban settings should try to reduce sedentary behavior by offering group-based activities, particularly in deprived areas where current provision is limited.

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

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).

Better Outcomes for Older people with Spinal Trouble (BOOST) Trial: a randomised controlled trial of a combined physical and psychological intervention for older adults with neurogenic claudication, a protocol.

INTRODUCTION: Neurogenic claudication due to spinal stenosis is common in older adults. The effectiveness of conservative interventions is not known. The aim of the study is to estimate the clinical and cost-effectiveness of a physiotherapist-delivered, combined physical and psychological intervention. METHODS AND ANALYSIS: This is a pragmatic, multicentred, randomised controlled trial. Participants are randomised to a combined physical and psychological intervention (Better Outcomes for Older people with Spinal Trouble (BOOST) programme) or best practice advice (control). Community-dwelling adults, 65 years and over, with neurogenic claudication are identified from community and secondary care services. Recruitment is supplemented using a primary care-based cohort. Participants are registered prospectively and randomised in a 2:1 ratio (intervention:control) using a web-based service to ensure allocation concealment. The target sample size is a minimum of 402. The BOOST programme consists of an individual assessment and twelve 90 min classes, including education and discussion underpinned by cognitive behavioural techniques, exercises and walking circuit. During and after the classes, participants undertake home exercises and there are two support telephone calls to promote adherence with the exercises. Best practice advice is delivered in one to three individual sessions with a physiotherapist. The primary outcome is the Oswestry Disability Index at 12 months. Secondary outcomes include the 6 Minute Walk Test, Short Physical Performance Battery, Fear Avoidance Beliefs Questionnaire and Gait Self-Efficacy Scale. Outcomes are measured at 6 and 12 months by researchers who are masked to treatment allocation. The primary statistical analysis will be by 'intention to treat'. There is a parallel health economic evaluation and qualitative study. ETHICS AND DISSEMINATION: Ethical approval was given on 3 March 2016 (National Research Ethics Committee number: 16/LO/0349). This protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials checklist. The results will be reported at conferences and in peer-reviewed publications using the Consolidated Standards of Reporting Trials guidelines. A plain English summary will be published on the BOOST website. TRIAL REGISTRATION NUMBER: ISRCTN12698674; Pre-results.

Effectiveness of physical activity interventions in achieving behaviour change maintenance in young and middle aged adults: A systematic review and meta-analysis.

BACKGROUND: Physical activity (PA) interventions are generally effective in supporting short-term behaviour change, but increases are not always maintained. This review examined the effectiveness of PA interventions for behaviour change maintenance in young and middle-aged adults, and investigated which Behaviour Change Techniques (BCTs) and other intervention features were associated with maintenance. METHODS: Six databases (Medline, EMBASE, PsycINFO, Cochrane Database of Systematic Reviews, CINAHL, Web of Science) were systematically searched. Eligibility criteria were controlled trials investigating the effectiveness of PA interventions with adult (mean age 18-64 years) non-clinical populations using validated measures of PA behaviour at baseline and ≥six months' post-baseline. Results were pooled in meta-analyses using standardised mean differences (SMD) at five time intervals (6-9, 9-15, 15-21, 21-24, >24 months). Moderator analyses investigated the influence of sample and intervention characteristics on PA maintenance at 6-9 months. RESULTS: Sixty-two studies were included. PA interventions had a significant effect on behaviour maintenance 6-15 months post-baseline relative to controls. Interventions had a larger effect on maintenance at 6-9 months (SMD = 0.28; 95% CI: 0.20, 0.35; I2 = 73%) compared to 9-15 months (SMD = 0.20; 95% CI: 0.13, 0.26; I2 = 70%). Beyond 15 months, PA measurements were infrequent with little evidence supporting maintenance. Moderator analyses showed some BCTs and intervention settings moderated PA outcomes at 6-9 months. A multivariable meta-regression model showed interventions using the BCTs 'Prompt self-monitoring of behavioural outcome' (b = 1.46, p < 0.01) and 'Use of follow-up prompts' (b = 0.38, p < 0.01) demonstrated greater effectiveness at promoting PA maintenance at 6-9 months. Interventions implemented in primary care (versus community or workplace/university) settings (b = -0.13, p = 0.10) tended to demonstrate less effectiveness. CONCLUSIONS: This review provides evidence of some effective BCTs for maintaining behaviour to 15 months. Greater consideration must be given to how future interventions encourage and measure maintenance of changes, and investigate broader psychological, social and environmental influences of PA behaviour. PROSPERO REGISTRATION: PROSPERO 2015:CRD42015025462.