A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance.

The UK Medical Research Council's widely used guidance for developing and evaluating complex interventions has been replaced by a new framework, commissioned jointly by the Medical Research Council and the National Institute for Health Research, which takes account of recent developments in theory and methods and the need to maximise the efficiency, use, and impact of research.

Large walking and wellbeing behaviour benefits of co-designed sustainable park improvements: A natural experimental study in a UK deprived urban area.

There is little robust evidence of how sustainable park interventions impact on physical activity and other behaviours important for wellbeing. This controlled natural experimental study aimed to examine the effects of co-designing a sustainable park intervention, in a deprived UK urban area, on walking and other wellbeing behaviours. Behaviour observations were conducted at two intervention sites and two matched comparison sites (n = 4,783). Walking observations (primary outcome), wellbeing behaviours (vigorous, sedentary, social and take notice activities) and demographic characteristics were assessed at pre-intervention, and post-intervention (3 and 15 months). Outcomes were compared between intervention and comparison groups, controlling for pre-intervention using multilevel negative binomial regression models. Additional behaviour observations were conducted in two unchanged nearby sites to assess changes in general local activity. Intercept surveys (n = 623) assessed change in self-reported outdoor space usage at intervention and control areas. Post-intervention, walking increased 203 % at 3 months (IRR 2·03, 95 % CI 1·01-4·09) and 351 % at 15 months (IRR 3·51, 95 % CI 2·07-5·93), for intervention sites relative to comparison sites. Large increases for other wellbeing behaviours were also observed. The proportion of non-white persons increased substantially post-intervention, compared to comparison sites. Nearby unchanged sites showed little evidence of general increased activity. Self-reported outdoor usage increased more in the intervention sites (p=<0·001). Sustainable solutions can yield large increases in walking and wellbeing in deprived areas, especially where interventions are co-designed with residents. More collaborative and robust natural experimental studies like this are needed to better inform decision-makers how to maximise health and wellbeing outcomes from sustainable interventions.

Emotion constructs and outcome measures following false positive breast screening test results: A systematic review of reporting clarity and selection rationale.

OBJECTIVE: (i) To systematically identify constructs and outcome measures used to assess the emotional and mood impact of false positive breast screening test results; (ii) to appraise the reporting clarity and rationale for selecting constructs and outcome measures. METHODS: Databases (MEDLINE, CINAHL, PsycINFO) were systematically searched from 1970. Studies using standardised and non-standardised outcome measures to evaluate the emotion or mood impact of false positive breast screening test results were eligible. A 15-item coding scheme was devised to appraise articles on clarity and rationale for selected constructs and measures. RESULTS: Forty-seven articles were identified. The most investigated constructs were general anxiety and depression and disease-specific anxiety and worry. Twenty-two standardised general outcome questionnaire measures and three standardised disease-specific outcome questionnaire measures were identified. Twenty articles used non-standardised scales/items. Reporting of constructs and outcome measures was generally clear, but rationales for their selection were lacking. Anxiety was typically justified, but justification for depression was almost always absent. Practical and psychometric justification for selecting outcome measures was lacking, and theoretical rationale was absent. CONCLUSIONS: Heterogeneity in constructs and measures, coupled with unclear rationale for these, impedes a thorough understanding of why there are emotional effects of false positive screening test results. This may explain the repeated practice of investigating less relevant outcomes such as depression. There is need to develop a consensual conceptual model of and standardised approach to measuring emotional impact from cancer screening test results, to address heterogeneity and other known issues of interpreting an inconsistent evidence base.

Healthcare professionals' experiences of caring for women with false-positive screening test results in the National Health Service Breast Screening Programme.

BACKGROUND: Understanding healthcare professionals' (HCPs) experiences of caring for women with false-positive screening test results in the National Health Service Breast Screening Programme (NHSBSP) is important for reducing the impact of such results. METHODS: Interviews were undertaken with 12 HCPs from a single NHSBSP unit, including advanced radiographer practitioners, breast radiographers, breast radiologists, clinical nurse specialists (CNSs), and a radiology healthcare assistant. Data were analysed thematically using Template Analysis. RESULTS: Two themes were produced: (1) Gauging and navigating women's anxiety during screening assessment was an inevitable and necessary task for all participants. CNSs were perceived as particularly adept at this, while breast radiographers reported a lack of adequate formal training. (2) Controlling the delivery of information to women (including amount, type and timing of information). HCPs reported various communication strategies to facilitate women's information processing and retention during a distressing time. CONCLUSIONS: Women's anxiety could be reduced through dedicated CNS support, but this should not replace support from other HCPs. Breast radiographers may benefit from more training to emotionally support recalled women. While HCPs emphasised taking a patient-centred communication approach, the use of other strategies (e.g., standardised scripts) and the constraints of the 'one-stop shop' model pose challenges to such an approach. PATIENT AND PUBLIC CONTRIBUTION: During the study design, two Patient and Public Involvement members (women with false-positive-breast screening test results) were consulted to gain an understanding of patient perspectives and experiences of being recalled specifically in the NHSBSP. Their feedback informed the formulations of the research aim, objectives and the direction of the interview guide.

Untapped Potential of Unobtrusive Observation for Studying Health Behaviors.

Improving the environment is an important upstream intervention to promote population health by influencing health behaviors such as physical activity, smoking, and social distancing. Examples of promising environmental interventions include creating high-quality green spaces, building active transport infrastructure, and implementing urban planning regulations. However, there is little robust evidence to inform policy and decision makers about what kinds of environmental interventions are effective and for which populations. In this viewpoint, we make the case that this evidence gap exists partly because health behavior research is dominated by obtrusive methods that focus on studying individual behavior and that are less suitable for understanding environmental influences. In contrast, unobtrusive observation can assess how behavior varies in different environmental contexts. It thereby provides valuable data relating to how environments affect the behavior of populations, which is often useful knowledge for effectively and equitably tackling population health challenges such as obesity and noncommunicable diseases. Yet despite a long history, unobtrusive observation methods are currently underused in health behavior research. We discuss how developing the use of video technology and automated computer vision techniques can offer a scalable solution for assessing health behaviors, facilitating a more thorough investigation of how environments influence health behaviors. We also reflect on the important ethical challenges associated with unobtrusive observation and the use of these emerging video technologies. By increasing the use of unobtrusive observation alongside other methods, we strongly believe this will improve our understanding of the influences of the environment on health behaviors.

Radiographic bone loss around dental implants: a large-cohort, long-term follow-up revealing prevalence and predictive factors.

OBJECTIVE: This retrospective study analyzed radiographic bone levels of 10,871 dental implants in a cohort of 4,247 patients over a 22-year period. The objectives of the study were to assess and explore risk factors associated with the radiographic bone level of dental implants. METHOD AND MATERIALS: A longitudinal observational cohort study based on data collected from 1995 to 2019 was conducted on implants placed by a single periodontist. Inclusion criteria included both partially and fully edentulous sites. Exclusion criteria were patients who were considered ASA 3 or greater. Information on medical and dental status prior to implant placement such as diabetes and smoking were included in the analysis. Implant factors such as the implant characteristics (length and diameter) and surgical site were recorded. The outcome assessed was the prevalence of bone loss around implants and any associative factors related to the bone loss. RESULTS: Overall, dental implants lost an average of 0.05 ± 0.38 mm of bone 2 to 3 years after placement and 0.21 ± 0.64 mm 8 years after placement. The soft tissue condition was evaluated using the Implant Mucosal Index (IMI), and bone loss around dental implants was significantly higher when bleeding on probing was multi-point and moderate, multi-point and profuse, and when infection with suppuration was recorded. The mean difference in bone level between smokers and nonsmokers was 0.26 mm (P < .01) over a 4-year period. A mean difference of 0.10 mm (P = .04) in bone loss over 4 years was found between those with an autoimmune disease compared to those without. The diameter of the implant and immediate loading of the dental implant did not influence the radiographic bone levels over time. CONCLUSIONS: This large dataset of dental implants highlights predictive risk factors for bone loss around dental implants and the impact these risk factors have on the implant bone level. Consideration of these risk factors by both the dental team and the patient prior to dental implant placement will promote success of the treatment.

Supporting people with type 2 diabetes in effective use of their medicine through mobile health technology integrated with clinical care (SuMMiT-D pilot): results of a feasibility randomised trial.

BACKGROUND: The purpose of this 6-month intervention pilot feasibility randomised trial was to test sending brief messages using mobile phones to promote self-management through taking medication as prescribed to people with type 2 diabetes. This was to inform the design and conduct of a future large-scale United Kingdom-based clinical trial and establish the feasibility of recruitment, the technology used, follow-up, and data collection. METHODS: A multicentre individually randomised, controlled parallel group trial in primary care, recruiting adults (≥ 35 years) with type 2 diabetes in England. Consenting participants were randomly allocated to receive short message system text messages up to four times a week, or usual care, for a period of 6 months; messages contained behavioural change techniques targeting medication use. The primary outcome was the rate of recruitment to randomisation of participants to the trial with a planned rate of 22 participants randomised per month. The study also aimed to establish the feasibility of follow-up at 6 months, with an aim of retaining more than 80% of participants. Data, including patient-reported measures, were collected at baseline and the end of the 6-month follow-up period, and a notes review was completed at 24 months. RESULTS: The trial took place between 26 November 2018 and 30 September 2019. In total 209 participants were randomly allocated to intervention (n = 103) or usual care (n = 106). The maximum rate of monthly recruitment to the trial was 60-80 participants per month. In total, 12,734 messages were sent to participants. Of these messages, 47 were identified as having failed to be sent by the service provider. Participants sent 2,864 messages to the automated messaging system. Baseline data from medical records were available for > 90% of participants with the exception of cholesterol (78.9%). At 6 months, a further HbA1c measurement was reported for 67% of participants. In total medical record data were available at 6 months for 207 (99.0%) of participants and completed self-report data were available for 177 (84.7%) of participants. CONCLUSION: The feasibility of a large-scale randomised evaluation of brief message intervention for people with type 2 diabetes appears to be high using this efficient design. Failure rate of sending messages is low, rapid recruitment was achieved among people with type 2 diabetes, clinical data is available on participants from routine medical records and self-report of economic measures was acceptable. TRIAL REGISTRATION: ISCTRN ISRCTN13404264. Registered on 10 October 2018.

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.

Experiences of online group support for engaging and supporting participants in the National Health Service Digital Diabetes Prevention Programme: A qualitative interview study.

OBJECTIVES: The National Health Service Digital Diabetes Prevention Programme is a nine-month behavioural intervention for adults in England at risk of type 2 diabetes. This qualitative study aimed to explore how service users engaged with the group support available within the programme. METHODS: The majority of participants (n = 33), all service users, were interviewed twice via telephone, at 2-4 months into the programme, and at the end of the programme at 8-10 months. Semi-structured interviews covered participants' experiences of online group support functions and how such groups served as a route of support to aid participants' behavioural changes. Data were analysed using manifest thematic analysis. RESULTS: The majority of participants valued the format of closed group chats, which provided an interactive platform to offer and receive support during their behaviour change journey. However, engagement with group chats reduced over time, and some participants did not find them useful when there was a lack of common interests within the group. Health coaches helped to promote engagement and build rapport among participants within the group chats. Participants reported mixed experiences of discussion forums. CONCLUSIONS: Programme developers should consider how to optimise online group support to help service users make behavioural changes, in terms of format, participant composition and use of health coach moderators. Further research is required to better understand who might benefit most from 'group chat' or 'discussion forum' support. Health coach moderation of online support groups is likely to facilitate engagement.

Impact of a prehabilitation and recovery programme on emotional well-being in individuals undergoing cancer surgery: a multi-perspective qualitative study.

BACKGROUND: Prehabilitation and recovery programmes aim to optimise patients' physical fitness and mental well-being before, during and after cancer treatment. This paper aimed to understand the impact of such a programme on emotional well-being in individuals undergoing cancer surgery. The programme was multi-modal, containing physical activity, well-being and nutritional support. METHODS: Qualitative interviews were conducted with 16 individuals who participated in a prehabilitation and recovery programme. Twenty-four health care staff involved in referral completed an online survey. An inductive, thematic analysis was conducted, integrating perspectives of patients and staff, structured with the Framework approach. RESULTS: Patients seemed to experience emotional benefits from the programme, appearing less anxious and more confident in their ability to cope with treatment. They seemed to value having something positive to focus on and control over an aspect of treatment. Ongoing, implicit psychological support provided by Exercise Specialists, who were perceived as expert, available and caring, seemed valued. Some patients appeared to appreciate opportunities to talk about cancer with peers and professionals. Discomfort with talking about cancer with other people, outside of the programme, was expressed. CONCLUSIONS: Participation in a prehabilitation and recovery programme appeared to yield valuable emotional well-being benefits, even without referral to specialist psychological support. STUDY REGISTRATION: The study protocol was uploaded onto the Open Science Framework 24 September 2020 ( https://osf.io/347qj/ ).

The state of knowledge regarding delivering behavior change techniques via short text messages is already quite advanced: A response to "Can behavior change techniques be delivered via short text messages?"

Dogru et al. recent study reported developing text messages that attempted to capture each of 93 behavior change techniques (BCTs) in a standardized taxonomy. They found that a panel of experts identified the majority of the messages developed as having good fidelity to the intended BCTs. While this work has clear merit, we do not believe it accurately reflects the large body of existing research in this area. A process of producing text messages to address BCTs that yielded high fidelity has previously been reported. Furthermore, this work showed that messages developed for one behavior can be modified to address another behavior with similarly good fidelity. Importantly, these messages have been shown to successfully change target constructs in an experimental study and are being used in a randomized trial that has recently completed recruitment of over 1000 people with Type 2 diabetes.

Dogru et al. developed a list of text messages to deliver behavior change techniques (BCTs). BCTs are methods for changing behavior and a standardized taxonomy has described 93 such BCTs. The authors found that of 93 messages addressing these 93 BCTs, 66 of the messages were agreed by experts to deliver the intended BCT. According to the authors, the next step would be to analyze the effectiveness of the messages. This work has clear merit, however, the suggested process does not accurately represent the work that has already been done in this area. A body of work has developed text messages to target adherence to medication in people with Type 2 diabetes. These messages were rated by experts as delivering the intended BCTs and were rated as acceptable by people with Type 2 diabetes. Furthermore, these messages have been successfully modified to address other behaviors such as diet and physical activity with experts rating these messages as delivering the intended BCTs. These messages have been found to change constructs such as intention when delivered in an experimental study and are now being used in a randomized controlled trial that has completed recruitment of over 1000 people with Type 2 diabetes.

Acceptability, fidelity and trial experience of four intervention components to support medication adherence in women with breast cancer: A process evaluation protocol for a pilot fractional factorial trial.

Background: The Refining and Optimising a behavioural intervention to Support Endocrine Therapy Adherence (ROSETA) programme has developed four intervention components aiming to improve medication adherence in women with early-stage breast cancer. These are (a) text messages, (b) information leaflet, (c) Acceptance and Commitment Therapy-based guided self-help (ACT), (d) side-effect management website. Guided by the Multiphase Optimisation Strategy, our pilot trial will use a fractional factorial design to evaluate the feasibility of undertaking a larger optimisation trial. The pilot will include a process evaluation to maximise learning regarding the fidelity and acceptability of the intervention components before proceeding with a larger trial. The trial process evaluation has three aims: to assess the (1) fidelity and (2) acceptability of the intervention components; and (3) to understand participant's trial experience, and barriers and facilitators to recruitment and retention. Methods: The process evaluation will use multiple methods. Fidelity of the intervention components will be assessed using self-reported questionnaire data, trial data on intervention component adherence, and observations of the ACT sessions. Acceptability of the intervention components and trial experience will be explored using an acceptability questionnaire and interviews with patients and trial therapists. Trial experience will be assessed using a questionnaire and interviews with participants, while barriers and facilitators to recruitment and retention will be assessed using a questionnaire completed by research nurses and participant interviews. The pilot trial opened for recruitment on 20th May 2022 and was open at the time of submission. Conclusions: This process evaluation will provide information regarding whether the intervention components can be delivered with fidelity within a national healthcare setting and are acceptable to participants. We will also better understand participant experience in a pilot trial with a fractional factorial design, and any barriers and facilitators to recruitment and retention. Registration: ISRCTN registry ( ISRCTN10487576, 16/12/2021).

BACKGROUND: The majority of women with early-stage breast cancer are recommended adjuvant endocrine therapy (AET) to reduce the chances of their cancer coming back. Many women given this medication don't take it every day or stop taking it earlier than they should. We have developed four different interventions to help women take AET. These are; text messages reminding women to take AET; an information leaflet explaining how AET works and its benefits and side-effects; a therapy programme to reduce distress, consisting of five support sessions and four module booklets; and a website with strategies to manage AET side-effects. We are now testing whether these interventions can be delivered within the NHS in different combinations, in a small trial. STUDY METHODS: We have three aims: 1. To find out if the interventions can be given and are received in the way they were supposed to (fidelity).2. To find out if the support received as part of the trial was acceptable to women with breast cancer (acceptability).3. To find out what women's experience was of taking part in the trial overall (trial experience). To do this we will: 1. Interview participants to ask them how acceptable they found the interventions, what they understood, whether they used the interventions, and how they found participating in the trial.2. Interview therapists who delivered the therapy programme to see if they delivered it as they were supposed to, and how they found delivering the intervention.3. Ask participants to complete questionnaires about how acceptable the interventions were, and whether they read and used them.4. Ask the staff involved in finding participants for the trial about challenges and improvements. We will use what we find to make improvements in a future trial where we will test whether the interventions help women to take AET.

Diabetes prevention at scale: Narrative review of findings and lessons from the DIPLOMA evaluation of the NHS Diabetes Prevention Programme in England.

AIMS: The NHS Diabetes Prevention Programme (NHS DPP) is a large-scale, England-wide behaviour change programme for people at high risk of progressing to type 2 diabetes. We summarise the findings of our six-year DIPLOMA evaluation of its implementation and impact and highlight insights for future programmes. METHODS: Using qualitative interviews, document analysis, observation, surveys and large dataset analysis, eight interlinked work packages considered: equity of access; implementation; service delivery and fidelity; programme outcomes; comparative effectiveness and cost-effectiveness in reducing diabetes incidence; and patient decision making and experience. RESULTS: Delivery of the NHS DPP encountered barriers across many aspects of the programme, and we identified inequalities in terms of the areas, organisations and patient populations most likely to engage with the programme. There was some loss of fidelity at all stages from commissioning to participant understanding. Despite these challenges, there was evidence of significant reductions in diabetes incidence at individual and population levels. The programme was cost-effective even within a short time period. CONCLUSIONS: Despite the challenge of translating research evidence into routine NHS delivery at scale, our findings suggest that an individual-level approach to the prevention of type 2 diabetes in a 'high-risk' population was more effective than usual care. By embedding evaluation with programme delivery and working closely with the NHS DPP team, we provided actionable insights for improving communications with potential participants, supporting primary care referral, honing the delivery model with better provider relationships and more patient choice, increasing understanding of behaviour change techniques, and enriching the educational and health coaching content.

Acceptability of prehabilitation for cancer surgery: a multi-perspective qualitative investigation of patient and 'clinician' experiences.

BACKGROUND: 'Prehabilitation' interventions aim to enhance individuals' physical fitness prior to cancer treatment, typically involve exercise training as a key component, and may continue to support physical activity, strength, and fitness during or after treatment. However, uptake of prehabilitation is variable. This study investigated how patients from diverse socio-economic status groups perceived an exemplar prehabilitation and recovery programme, aiming to understand factors impacting acceptability, engagement and referral. METHODS: This research was conducted in the context of the Prehab4Cancer and Recovery Programme, a prehabilitation and recovery programme available across Greater Manchester, UK. Qualitative, semi-structured phone/video-call interviews were conducted with 18 adult patient participants referred to the programme (16 'engagers', 2 'non-engagers'; half the sample lived in localities with low socio-economic status scores). An online questionnaire with free-response and categorical-response questions was completed by 24 'clinician' participants involved in referral (nurses, doctors and other staff roles). An inductive, multi-perspective, thematic analysis was performed, structured using the Framework approach. RESULTS: Discussing and referring patients to prehabilitation can be challenging due to large quantities of information for staff to cover, and for patients to absorb, around the time of diagnosis. The programme was highly valued by both participant groups; the belief that participation would improve recovery seemed a major motivator for engagement, and some 'clinicians' felt that prehabilitation should be treated as a routine part of treatment, or extended to support other patient groups. Engagers seemed to appreciate a supportive approach where they did not feel forced to do any activity and tailoring of the programme to meet individual needs and abilities was appreciated. Initial engagement could be daunting, but gaining experience with the programme seemed to increase confidence. CONCLUSIONS: The prehabilitation programme was highly valued by engagers. Introducing prehabilitation at a challenging time means that personalised approaches might be needed to support engagement, or participation could be encouraged at a later time. Strategies to support individuals lacking in confidence, such as buddying, may be valuable. STUDY REGISTRATION: The study protocol was uploaded onto the Open Science Framework 24 September 2020 ( https://osf.io/347qj/ ).

Engagement with a nationally-implemented digital behaviour change intervention: Usage patterns over the 9-month duration of the National Health Service Digital Diabetes Prevention Programme.

Background: Digital behaviour change interventions may offer a scalable way to promote weight loss by increasing physical activity and improving diet. However, user engagement is necessary for such benefits to be achieved. There is a dearth of research that assesses engagement with nationally implemented digital programmes offered in routine practice. The National Health Service Digital Diabetes Prevention Programme (NHS-DDPP) is a nine-month digital behaviour change intervention delivered by independent providers for adults in England who are at high risk of developing type 2 diabetes. This study reports engagement with the NHS-DDPP for users enrolled onto the programme over the nine-month duration. Methods: Anonymous usage data was obtained for a cohort of service users (n = 1826) enrolled on the NHS-DDPP with three independent providers, between December 2020 and June 2021. Usage data were obtained for time spent in app, and frequency of use of NHS-DDPP intervention features in the apps including self-monitoring, goal setting, receiving educational content (via articles) and social support (via health coaches and group forums), to allow patterns of usage of these key features to be quantified across the nine-month intervention. Median usage was calculated within nine 30-day engagement periods to allow a longitudinal analysis of the dose of usage for each feature. Results: App usage declined from a median of 32 min (IQR 191) in month one to 0 min (IQR 14) in month nine. Users self-monitored their behaviours (e.g., physical activity and diet) a median of 117 times (IQR 451) in the apps over the nine-month programme. The open group discussion forums were utilised less regularly (accessed a median of 0 times at all time-points). There was higher engagement with some intervention features (e.g., goal setting) when support from a health coach was linked to those features. Conclusions: App usage decreased over the nine-month programme, although the rate at which the decrease occurred varied substantially between individuals and providers. Health coach support may promote engagement with specific intervention features. Future research should assess whether engagement with particular features of digital diabetes prevention programmes is associated with outcomes such as reduced bodyweight and HbA1c levels.

Optimization of an Information Leaflet to Influence Medication Beliefs in Women With Breast Cancer: A Randomized Factorial Experiment.

BACKGROUND: Adherence to adjuvant endocrine therapy (AET) is low in women with breast cancer. Negative beliefs about the necessity of AET and high concerns are barriers to adherence. PURPOSE: To use the multiphase optimization strategy to optimize the content of an information leaflet intervention, to change AET beliefs. METHODS: We conducted an online screening experiment using a 25 factorial design to optimize the leaflet. The leaflet had five components, each with two levels: (i) diagrams about AET mechanisms (on/off); (ii) infographics displaying AET benefits (enhanced/basic); (iii) AET side effects (enhanced/basic); (iv) answers to AET concerns (on/off); (v) breast cancer survivor (patient) input: quotes and photographs (on/off). Healthy adult women (n = 1,604), recruited via a market research company, were randomized to 1 of 32 experimental conditions, which determined the levels of components received. Participants completed the Beliefs about Medicines Questionnaire before and after viewing the leaflet. RESULTS: There was a significant main effect of patient input on beliefs about medication (ß = 0.063, p < .001). There was one significant synergistic two-way interaction between diagrams and benefits (ß = 0.047, p = .006), and one antagonistic two-way interaction between diagrams and side effects (ß = -0.029, p = .093). There was a synergistic three-way interaction between diagrams, concerns, and patient input (ß = 0.029, p = .085), and an antagonistic four-way interaction between diagrams, benefits, side effects, and concerns (ß = -0.038, p = .024). In a stepped approach, we screened in four components and screened out the side effects component. CONCLUSIONS: The optimized leaflet did not contain enhanced AET side effect information. Factorial experiments are efficient and effective for refining the content of information leaflet interventions.

Adjuvant endocrine therapy (AET) is a medication given to women to stop breast cancer from returning. Many women do not take AET every day or stop taking it before they should. Some women do not take AET because they do not believe it will help them, or they have concerns about the side effects. We ran an online study aiming to create the best information leaflet to help women understand how AET is helpful and to reduce their concerns. The leaflet had five sections; diagrams explaining how AET works, visual pictures of the benefits of AET, information about the side effects, answers to common concerns, and quotes from other women with breast cancer. 1,604 healthy women filled in a questionnaire before and after looking at an information leaflet about AET. Women received different combinations of the five sections of the information leaflet. We found quotes from other women with breast cancer led to more positive beliefs about AET. Some sections of the leaflet worked better in combination, while other sections were worse in combination. Our results led us to remove the detailed side effect information from the leaflet, as in combination with the other sections this negatively affected women's beliefs about AET.

How do women at increased risk of breast cancer make sense of their risk? An interpretative phenomenological analysis.

OBJECTIVES: Offering breast cancer risk prediction for all women of screening age is being considered globally. For women who have received a clinically derived estimate, risk appraisals are often inaccurate. This study aimed to gain an in-depth understanding of women's lived experiences of receiving an increased breast cancer risk. DESIGN: One-to-one semi-structured telephone interviews. METHODS: Eight women informed that they were at a 10-year above-average (moderate) or high risk in a breast cancer risk study (BC-Predict) were interviewed about their views on breast cancer, personal breast cancer risk and risk prevention. Interviews lasted between 40 and 70 min. Data were analysed using Interpretative Phenomenological Analysis. RESULTS: Four themes were generated: (i) encounters with breast cancer and perceived personal significance, where the nature of women's lived experiences of others with breast cancer impacted their views on the significance of the disease, (ii) 'It's random really': difficulty in seeking causal attributions, where women encountered contradictions and confusion in attributing causes to breast cancer, (iii) believing versus identifying with a clinically-derived breast cancer risk, where personal risk appraisals and expectations influenced women's ability to internalize their clinically derived risk and pursue preventative action and (iv) perceived utility of breast cancer risk notification, where women reflected on the usefulness of knowing their risk. CONCLUSIONS: Providing (numerical) risk estimates appear to have little impact on stable yet internally contradictory beliefs about breast cancer risk. Given this, discussions with healthcare professionals are needed to help women form more accurate appraisals and make informed decisions.

"I don't know what I'm feeling for": young women's beliefs about breast cancer risk and experiences of breast awareness.

BACKGROUND: Younger women are often diagnosed with advanced breast cancer. Beliefs about risk are instrumental in motivating many health protective behaviours, but there may be confusion around which behaviour is appropriate to detect breast cancer earlier. Breast awareness, defined as an understanding of how the breasts look and feel so changes can be identified early, is widely recommended. In contrast, breast self-examination involves palpation using a specified method. We aimed to investigate young women's beliefs about their risk and experiences of breast awareness. METHODS: Thirty-seven women aged 30-39 years residing in a North West region of England with no family or personal history of breast cancer participated in seven focus groups (n = 29) and eight individual interviews. Data were analysed using reflexive thematic analysis. RESULTS: Three themes were generated. "Future me's problem" describes why women perceive breast cancer as an older woman's disease. Uncertainty regarding checking behaviours highlights how confusion about self-checking behaviour advice has resulted in women infrequently performing breast checks. Campaigns as a missed opportunity highlights the potential negative effects of current breast cancer fundraising campaigns and the perceived absence of educational campaigning about breast cancer for this demographic. CONCLUSIONS: Young women expressed low perceived susceptibility to developing breast cancer in the near future. Women did not know what breast self-checking behaviours they should be performing and expressed a lack of confidence in how to perform a breast check appropriately due to limited knowledge about what to look and feel for. Consequently, women reported disengagement with breast awareness. Defining and clearly communicating the best strategy for breast awareness and establishing whether it is beneficial or not are essential next steps.

Implementing a text message-based intervention to support type 2 diabetes medication adherence in primary care: a qualitative study with general practice staff.

BACKGROUND: The Support through Mobile Messaging and digital health Technology for Diabetes (SuMMiT-D) project has developed, and is evaluating, a mobile phone-based intervention delivering brief messages targeting identified behaviour change techniques promoting medication use to people with type 2 diabetes in general practice. The present study aimed to inform refinement and future implementation of the SuMMiT-D intervention by investigating general practice staff perceptions of how a text message-based intervention to support medication adherence should be implemented within current and future diabetes care. METHODS: Seven focus groups and five interviews were conducted with 46 general practice staff (including GPs, nurses, healthcare assistants, receptionists and linked pharmacists) with a potential role in the implementation of a text message-based intervention for people with type 2 diabetes. Interviews and focus groups were audio-recorded, transcribed and analysed using an inductive thematic analysis approach. RESULTS: Five themes were developed. One theme 'The potential of technology as a patient ally' described a need for diabetes support and the potential of technology to support medication use. Two themes outlined challenges to implementation, 'Limited resources and assigning responsibility' and 'Treating the patient; more than diabetes medication adherence'. The final two themes described recommendations to support implementation, 'Selling the intervention: what do general practice staff need to see?' and 'Fitting the mould; complementing current service delivery'. CONCLUSIONS: Staff see the potential for a text message-based support intervention to address unmet needs and to enhance care for people with diabetes. Digital interventions, such as SuMMiT-D, need to be compatible with existing systems, demonstrate measurable benefits, be incentivised and be quick and easy for staff to engage with. Interventions also need to be perceived to address general practice priorities, such as taking a holistic approach to care and having multi-cultural reach and relevance. Findings from this study are being combined with parallel work with people with type 2 diabetes to ensure stakeholder views inform further refinement and implementation of the SuMMiT-D intervention.

Estimating the Cost of 3 Risk Prediction Strategies for Potential Use in the United Kingdom National Breast Screening Program.

Background: Economic evaluations have suggested that risk-stratified breast cancer screening may be cost-effective but have used assumptions to estimate the cost of risk prediction. The aim of this study was to identify and quantify the resource use and associated costs required to introduce a breast cancer risk-stratification approach into the English national breast screening program. Methods: A micro-costing study, conducted alongside a cohort-based prospective trial (BC-PREDICT), identified the resource use and cost per individual (£; 2021 price year) of providing a risk-stratification strategy at a woman's first mammography. Costs were calculated for 3 risk-stratification approaches: Tyrer-Cuzick survey, Tyrer-Cuzick with Volpara breast-density measurement, and Tyrer-Cuzick with Volpara breast-density measurement and testing for 142 single nucleotide polymorphisms (SNP). Costs were determined for the intervention as implemented in the trial and in the health service. Results: The cost of providing the risk-stratification strategy was calculated to be £16.45 for the Tyrer-Cuzick survey approach, £21.82 for the Tyrer-Cuzick with Volpara breast-density measurement, and £102.22 for the Tyrer-Cuzick with Volpara breast-density measurement and SNP testing. Limitations: This study did not use formal expert elicitation methods to synthesize estimates. Conclusion: The costs of risk prediction using a survey and breast density measurement were low, but adding SNP testing substantially increases costs. Implementation issues present in the trial may also significantly increase the cost of risk prediction. Implications: This is the first study to robustly estimate the cost of risk-stratification for breast cancer screening. The cost of risk prediction using questionnaires and automated breast density measurement was low, but full economic evaluations including accurate costs are required to provide evidence of the cost-effectiveness of risk-stratified breast cancer screening. Highlights: Economic evaluations have suggested that risk-stratified breast cancer screening may be a cost-effective use of resources in the United Kingdom.Current estimates of the cost of risk stratification are based on pragmatic assumptions.This study provides estimates of the cost of risk stratification using 3 strategies and when these strategies are implemented perfectly and imperfectly in the health system.The cost of risk stratification is relatively low unless single nucleotide polymorphisms are included in the strategy.