A mixed methods systematic literature review of barriers and facilitators to help-seeking among women with stigmatised pelvic health symptoms.

BACKGROUND: Women's pelvic health is a globally important subject, included in international and United Kingdom health policies, emphasising the importance of improving information and access to pelvic health services. Consequences of pelvic symptoms are intimate, personal, and varied, often causing embarrassment and shame, affecting women's quality of life and wellbeing. AIM: To understand the experience of seeking healthcare for stigmatised pelvic health symptoms by synthesising all types of published primary research and mapping the results to behavioural theory, to identify potential targets for intervention. METHODS: Systematic search of MEDLINE, CINAHL, PsycINFO, SocINDEX, PubMED databases, CDSR and CENTRAL registers, from inception to May 2023 for all types of research capturing women's views and experiences of seeking help with stigmatised urogenital and bowel symptoms. Studies only reporting prevalence, predictors of help-seeking, non-health related help-seeking, or written in languages other than English, German, French, Spanish and Swedish were excluded. Reference checking and forward citation searching for all included studies was performed. A results-based synthesis approach was used to integrate quantitative and qualitative data. Themes were mapped to the Common-Sense model and Candidacy framework. The Mixed Methods Appraisal Tool was used for critical appraisal. Grading of Recommendations Assessment, Development and Evaluation - Confidence in Evidence from Reviews of Qualitative research for assessing certainty of review findings. RESULTS: 86 studies representing over 20,000 women from 24 high income countries were included. Confidence was high that barriers to help-seeking were similar across all study types and pelvic symptoms: stigma, lack of knowledge, women's perception that clinicians dismissed their symptoms, and associated normalising and deprioritising of low bother symptoms. Supportive clinicians and increased knowledge were key facilitators. CONCLUSIONS: Using the Common-Sense Model to explore women's help-seeking behaviour with stigmatised pelvic symptoms reveals problems with cognitive representation of symptom identity, emotional representations of embarrassment and shame, and a subjective norm that women believe their symptoms will be trivialised by clinicians. Together these barriers frustrate women's identification of their candidacy for healthcare. Addressing these issues through behavioural change interventions for women and clinicians, will help to achieve universal access to pelvic healthcare services (United Nations Sustainable Development Goal 3.7). SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021256956.

Provider-recipient perspectives on how social support and social identities influence adaptation to psychological stress in sport.

Psychological stress can be both a help and a hindrance to wellbeing and performance in sport. The provision and receipt of social support is a key resource for managing adaptations to stress. However, extant literature in this area is largely limited to the recipient's perspective of social support. Furthermore, social support is not always effective, with evidence suggesting it can contribute to positive, negative, and indifferent adaptations to stress. As such, we do not know how social support influences adaptations to stress in sport. The social identity approach may explain how social support can lead to both positive and negative adaptations to stress. Our purpose in this study was to explore how social support and social identities influence adaptations to stress in a Rugby Academy Programme. Using qualitative methods within a naturalistic research paradigm, semi-structured interviews were conducted with Rugby Academy co-ordinators (n = 6) and players (n = 12), and four focus groups were conducted with teams of support staff (n = 18). Data were analyzed using reflexive thematic analysis, which generated seven sub-themes categorized into two higher-order analytical themes. Our results demonstrate that group-based perceptions of social support influence adaptations to stress. Specifically, whether social support influences positive, negative, or indifferent adaptations to stress depended on (1) social factors influencing the nature of social support, and (2) social factors influencing the provision and receipt of social support. These findings advance our understanding of how adaptations to stress are influenced by social support. Implications are offered for how organizations, teams, and practitioners can facilitate positive adaptations to stress in sport.

Promoting smoking cessation during pregnancy: A feasibility and pilot trial of a digital storytelling intervention delivered via text-messaging.

OBJECTIVE: Smoking during pregnancy causes risks to mother and infant health. We investigated the feasibility and likely success of SKIP-IT, a narrative and picture-based smoking cessation intervention delivered via text messages. METHODS: A feasibility and pilot trial. We aimed to recruit 70 pregnant women who smoked, randomised to usual care alone, or usual care and the SKIP-IT intervention, between 12 weeks of pregnancy and 6 weeks post due-date. Outcomes assessed were recruitment, retention, acceptability of, and engagement with the intervention, smoking behaviour, intentions, perceived risk, and self-efficacy. RESULTS: Of 312 women initially approached by smoking cessation services only 54 (17%) agreed to be contacted by the research team. Twenty were then either ineligible or uncontactable and 28 (82%) participated. Most women reported texts to be entertaining and helpful. The proportion of women not smoking at follow-up was lower in the intervention group, but numbers were too small to draw conclusions about effectiveness. CONCLUSION: The intervention was acceptable, but difficulty in making initial and follow-up contacts meant our methods were unfeasible for a larger trial. PRACTICE IMPLICATIONS: Digital Storytelling interventions could help women quit smoking, but further research is required to identify alternative methods for studies with pregnant women who smoke.

What Works in Implementing Patient Decision Aids in Routine Clinical Settings? A Rapid Realist Review and Update from the International Patient Decision Aid Standards Collaboration.

BACKGROUND: Decades of effectiveness research has established the benefits of using patient decision aids (PtDAs), yet broad clinical implementation has not yet occurred. Evidence to date is mainly derived from highly controlled settings; if clinicians and health care organizations are expected to embed PtDAs as a means to support person-centered care, we need to better understand what this might look like outside of a research setting. AIM: This review was conducted in response to the IPDAS Collaboration's evidence update process, which informs their published standards for PtDA quality and effectiveness. The aim was to develop context-specific program theories that explain why and how PtDAs are successfully implemented in routine healthcare settings. METHODS: Rapid realist review methodology was used to identify articles that could contribute to theory development. We engaged key experts and stakeholders to identify key sources; this was supplemented by electronic database (Medline and CINAHL), gray literature, and forward/backward search strategies. Initial theories were refined to develop realist context-mechanism-outcome configurations, and these were mapped to the Consolidated Framework for Implementation Research. RESULTS: We developed 8 refined theories, using data from 23 implementation studies (29 articles), to describe the mechanisms by which PtDAs become successfully implemented into routine clinical settings. Recommended implementation strategies derived from the program theory include 1) co-production of PtDA content and processes (or local adaptation), 2) training the entire team, 3) preparing and prompting patients to engage, 4) senior-level buy-in, and 5) measuring to improve. CONCLUSIONS: We recommend key strategies that organizations and individuals intending to embed PtDAs routinely can use as a practical guide. Further work is needed to understand the importance of context in the success of different implementation studies.

Implementing pelvic floor muscle training for women with pelvic organ prolapse: a realist evaluation of different delivery models.

BACKGROUND: Pelvic Floor Muscle Training (PFMT) has been shown to be effective for pelvic organ prolapse in women, but its implementation in routine practice is challenging due to lack of adequate specialist staff. It is important to know if PFMT can be delivered by different staff skill mixes, what barriers and facilitators operate in different contexts, what strategies enable successful implementation and what are the underlying mechanisms of their action. PROPEL intervention was designed to maximise the delivery of effective PFMT in the UK NHS using different staff skill mixes. We conducted a realist evaluation (RE) of this implementation to understand what works, for whom, in what circumstances and why. METHODS: Informed by the Realist and RE-AIM frameworks, the study used a longitudinal, qualitative, multiple case study design. The study took place in five, purposively selected, diverse NHS sites across the UK and proceeded in three phases to identify, test and refine a theory of change. Data collection took place at 4 time points over an 18 month implementation period using focus groups and semi-structured interviews with a range of stakeholders including service leads/managers, senior practitioners, newly trained staff and women receiving care in the new service models. Data were analysed using thematic framework approach adapted to identify Context, Mechanism and Outcome (CMO) configurations of the RE. RESULTS: A heightened awareness of the service need among staff and management was a mechanism for change, particularly in areas where there was a shortage of skilled staff. In contrast, the most established specialist physiotherapist-delivered PFMT service activated feelings of role protection and compromised quality, which restricted the reach of PFMT through alternative models. Staff with some level of prior knowledge in women's health and adequate organisational support were more comfortable and confident in new role. Implementation was seamless when PFMT delivery was incorporated in newly trained staff's role and core work. CONCLUSION: Roll-out of PFMT delivery through different staff skill mixes is possible when it is undertaken by clinicians with an interest in women's health, and carefully implemented ensuring adequate levels of training and ongoing support from specialists, multi-disciplinary teams and management.

Intraoral plasmablastic lymphoma as a primary oral manifestation: A case report and review of literature.

Plasmablastic lymphoma (PBL) is an aggressive type of large B-cell lymphoma as stated in the WHO classification of 2008. It is a rare form of non-Hodgkin's lymphoma, generally seen in human immunodeficiency virus (HIV)-acquired immunodeficiency syndrome affected individuals. A case of a 42-year-old female patient is presented here. The patient complained of swelling in the lower right back tooth region and presented with a history of extraction of molars. The underlying HIV status was detected after the oral examination. The diagnosis of PBL was confirmed with immunohistochemical analysis.

Associations between body dissatisfaction and self-reported anxiety and depression in otherwise healthy men: A systematic review and meta-analysis.

INTRODUCTION: It is unknown whether male body dissatisfaction is related to anxiety and depression. This study investigates whether there is an association between body dissatisfaction and self-reported anxiety and/or depression in otherwise healthy adult males. METHOD: A systematic review was conducted using Preferred Reporting Items for Systematic Reviews and Meta Analyses as the reporting guideline. Four databases including CINAHL complete, Health Source: Nursing/Academic Edition, MEDLINE and PsycINFO were searched for observational studies with a correlational design. Studies were appraised using the Appraisal tool for Cross-Sectional Studies to measure quality and risk of bias. Data were extracted from studies to analyse and synthesise findings using content analysis and random effects meta-analyses in male body dissatisfaction and anxiety, depression, and both anxiety and depression. RESULTS: Twenty-three cross-sectional studies were included in the review. Nineteen studies found positive correlations between male body dissatisfaction and anxiety and/or depression. Meta-analyses of Pearson's correlation coefficients found statistically significant associations with body satisfaction for anxiety 0.40 (95% CI 0.28 to 0.51) depression 0.34 (95% CI 0.22 to 0.45) and both anxiety and depression outcomes 0.47 (95% CI 0.33 to 0.59). The quality appraisal found study samples were homogeneous being mostly ascertained through academic institutions where participants were predominantly young, Caucasian and with relatively high educational attainment. Measures of body satisfaction focused predominantly on muscularity and thinness. DISCUSSION: This study provides the first pooled estimates of the correlation between body dissatisfaction and anxiety and depression in men. Findings need to be interpreted with respect to the samples and outcomes of the included studies. It is recommended that future research should increase the diversity of men in studies. Studies should measure a wider range of body dissatisfaction types found in men. CONCLUSION: The findings demonstrate that an association between male body dissatisfaction and anxiety and depression is likely to exist. Future research should address the temporal relationship between body dissatisfaction and anxiety and depression.

Reducing delay in patients with acute coronary syndrome and other time-critical conditions: a systematic review to identify the behaviour change techniques associated with effective interventions.

Background: Time to treatment in many conditions, particularly acute coronary syndrome, is critical to reducing mortality. Delay between onset of symptoms and treatment remains a worldwide problem. Reducing patient delay has been particularly challenging. Embedding behaviour change techniques (BCTs) within interventions might lead to shorter delay. Objective: To identify which BCTs are associated with reductions in patient delay among people with symptoms or conditions where time to treatment is critical. Methods: The data sources were Cochrane Library, MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, and PsycINFO. Study eligibility criteria include intervention evaluations (randomised controlled trials, controlled clinical trials and cohort studies) involving adults (aged >18 years) and including an outcome measure of patient delay up to August 2016. Study appraisal and synthesis methods include screening potential studies using a transparent, replicable process. Study characteristics, outcomes and BCTs were extracted from eligible studies. Results: From 39 studies (200 538 participants), just over half (n=20) reported a significant reduction in delay. 19 BCTs were identified, plus 5 additional techniques, with a mean of 2 (SD=2.3) BCTs and 2 (SD=0.7) per intervention. No clear pattern between BCTs and effectiveness was found. In studies examining patient delay specifically, three of four studies that included two or more BCTs, in addition to the two most commonly used additional techniques, reported a significant reduction in delay. Conclusions: Around half of the interventions to reduce prehospital delay with time-critical symptoms report a significant reduction in delay time. It is not clear what differentiates effective from non-effective interventions, although in relation to patient delay particularly additional use of BCTs might be helpful. Trial registration number: CRD42014013106.

Women's experiences of receiving care for pelvic organ prolapse: a qualitative study.

BACKGROUND: Pelvic organ prolapse is a common urogenital condition affecting 41-50% of women over the age of 40. To achieve early diagnosis and appropriate treatment, it is important that care is sensitive to and meets women's needs, throughout their patient journey. This study explored women's experiences of seeking diagnosis and treatment for prolapse and their needs and priorities for improving person-centred care. METHODS: Twenty-two women receiving prolapse care through urogynaecology services across three purposefully selected NHS UK sites took part in three focus groups and four telephone interviews. A topic guide facilitated discussions about women's experiences of prolapse, diagnosis, treatment, follow-up, interactions with healthcare professionals, overall service delivery, and ideals for future services to meet their needs. Data were analysed thematically. RESULTS: Three themes emerged relating to women's experiences of a) Evaluating what is normal b) Hobson's choice of treatment decisions, and c) The trial and error of treatment and technique. Women often delayed seeking help for their symptoms due to lack of awareness, embarrassment and stigma. When presented to GPs, their symptoms were often dismissed and unaddressed until they became more severe. Women reported receiving little or no choice in treatment decisions. Choices were often influenced by health professionals' preferences which were subtly reflected through the framing of the offer. Women's embodied knowledge of their condition and treatment was largely unheeded, resulting in decisions that were inconsistent with women's preferences and needs. Physiotherapy based interventions were reported as helping women regain control over their symptoms and life. A need for greater awareness of prolapse and physiotherapy interventions among women, GPs and consultants was identified alongside greater focus on prevention, early diagnosis and regular follow-up. Greater choice and involvement in treatment decision making was desired. CONCLUSIONS: As prolapse treatment options expand to include more conservative choices, greater awareness and education is needed among women and professionals about these as a first line treatment and preventive measure, alongside a multi-professional team approach to treatment decision making. Women presenting with prolapse symptoms need to be listened to by the health care team, offered better information about treatment choices, and supported to make a decision that is right for them.

Explanation and elaboration of the Standards for UNiversal reporting of patient Decision Aid Evaluations (SUNDAE) guidelines: examples of reporting SUNDAE items from patient decision aid evaluation literature.

This Explanation and Elaboration (E&E) article expands on the 26 items in the Standards for UNiversal reporting of Decision Aid Evaluations guidelines. The E&E provides a rationale for each item and includes examples for how each item has been reported in published papers evaluating patient decision aids. The E&E focuses on items key to reporting studies evaluating patient decision aids and is intended to be illustrative rather than restrictive. Authors and reviewers may wish to use the E&E broadly to inform structuring of patient decision aid evaluation reports, or use it as a reference to obtain details about how to report individual checklist items.

Standards for UNiversal reporting of patient Decision Aid Evaluation studies: the development of SUNDAE Checklist.

BACKGROUND: Patient decision aids (PDAs) are evidence-based tools designed to help patients make specific and deliberated choices among healthcare options. The International Patient Decision Aid Standards (IPDAS) Collaboration review papers and Cochrane systematic review of PDAs have found significant gaps in the reporting of evaluations of PDAs, including poor or limited reporting of PDA content, development methods and delivery. This study sought to develop and reach consensus on reporting guidelines to improve the quality of publications evaluating PDAs. METHODS: An international workgroup, consisting of members from IPDAS Collaboration, followed established methods to develop reporting guidelines for PDA evaluation studies. This paper describes the results from three completed phases: (1) planning, (2) drafting and (3) consensus, which included a modified, two-stage, online international Delphi process. The work was conducted over 2 years with bimonthly conference calls and three in-person meetings. The workgroup used input from these phases to produce a final set of recommended items in the form of a checklist. RESULTS: The SUNDAE Checklist (Standards for UNiversal reporting of patient Decision Aid Evaluations) includes 26 items recommended for studies reporting evaluations of PDAs. In the two-stage Delphi process, 117/143 (82%) experts from 14 countries completed round 1 and 96/117 (82%) completed round 2. Respondents reached a high level of consensus on the importance of the items and indicated strong willingness to use the items when reporting PDA studies. CONCLUSION: The SUNDAE Checklist will help ensure that reports of PDA evaluation studies are understandable, transparent and of high quality. A separate Explanation and Elaboration publication provides additional details to support use of the checklist.

Regenerative medicine: Stroke survivor and carer views and motivations towards a proposed stem cell clinical trial using placebo neurosurgery.

BACKGROUND: Few studies explore stroke survivor views and motivations towards stem cell therapy (SCT). This qualitative study explores the views and motivations of both stroke survivors and their partners/carers towards a proposed 2-arm Phase III Randomised Controlled Trial (RCT) comparing intracerebral insertion of stem cells with placebo neurosurgery in stroke survivors with disability. OBJECTIVE: To explore views and motivations towards a proposed 2-arm stem cell trial and identify factors that may impede and enhance participation. DESIGN: This study adopts a naturalistic design to explore the complexity of this field, employing a participatory action-research approach comprising a specialized Conversation (World) Café form of focus group. Data were collected via 5 Conversation Cafés with stroke survivors (age 40-75) and partners/carers between June and October 2016. Of 66 participants, 53 (31 male, 22 female) were stroke survivors and 13 (6 female, 7 male) were partners/carers. Qualitative data were analysed using a thematic approach. DISCUSSION AND CONCLUSION: Stroke survivor views and motivations reflect anticipation of the personal and future benefits of regenerative medicine. Partners/carers sought to balance the value of stroke survivor hope with carrying the weight of hope as carer, a conflict burden adding to known caregiver burden. All participants expressed the need for during and post-trial psychological support. This study provides a rare opportunity to explore the prospective views and motivations of stroke survivors and their partners/carers towards a proposed Phase III 2-arm RCT. This adds weight to qualitative evidence exploring capacity, consent, decision making, perceptions of treatment risk and supports required for clinical trial participation.

PROPEL: implementation of an evidence based pelvic floor muscle training intervention for women with pelvic organ prolapse: a realist evaluation and outcomes study protocol.

BACKGROUND: Pelvic Organ Prolapse (POP) is estimated to affect 41%-50% of women aged over 40. Findings from the multi-centre randomised controlled "Pelvic Organ Prolapse PhysiotherapY" (POPPY) trial showed that individualised pelvic floor muscle training (PFMT) was effective in reducing symptoms of prolapse, improved quality of life and showed clear potential to be cost-effective. However, provision of PFMT for prolapse continues to vary across the UK, with limited numbers of women's health physiotherapists specialising in its delivery. Implementation of this robust evidence from the POPPY trial will require attention to different models of delivery (e.g. staff skill mix) to fit with differing care environments. METHODS: A Realist Evaluation (RE) of implementation and outcomes of PFMT delivery in contrasting NHS settings will be conducted using multiple case study sites. Involving substantial local stakeholder engagement will permit a detailed exploration of how local sites make decisions on how to deliver PFMT and how these lead to service change. The RE will track how implementation is working; identify what influences outcomes; and, guided by the RE-AIM framework, will collect robust outcomes data. This will require mixed methods data collection and analysis. Qualitative data will be collected at four time-points across each site to understand local contexts and decisions regarding options for intervention delivery and to monitor implementation, uptake, adherence and outcomes. Patient outcome data will be collected at baseline, six months and one year follow-up for 120 women. Primary outcome will be the Pelvic Organ Prolapse Symptom Score (POP-SS). An economic evaluation will assess the costs and benefits associated with different delivery models taking account of further health care resource use by the women. Cost data will be combined with the primary outcome in a cost effectiveness analysis, and the EQ-5D-5L data in a cost utility analysis for each of the different models of delivery. DISCUSSION: Study of the implementation of varying models of service delivery of PFMT across contrasting sites combined with outcomes data and a cost effectiveness analysis will provide insight into the implementation and value of different models of PFMT service delivery and the cost benefits to the NHS in the longer term.

Reducing patient delay in Acute Coronary Syndrome (RAPiD): research protocol for a web-based randomized controlled trial examining the effect of a behaviour change intervention.

AIMS: To evaluate the efficacy of a behaviour change technique-based intervention and compare two possible modes of delivery (text + visual and text-only) with usual care. BACKGROUND: Patient delay prevents many people from achieving optimal benefit of time-dependent treatments for acute coronary syndrome. Reducing delay would reduce mortality and morbidity, but interventions to change behaviour have had mixed results. Systematic inclusion of behaviour change techniques or a visual mode of delivery might improve the efficacy of interventions. DESIGN: A three-arm web-based, parallel randomized controlled trial of a theory-based intervention. METHODS: The intervention comprises 12 behaviour change techniques systematically identified following systematic review and a consensus exercise undertaken with behaviour change experts. We aim to recruit n = 177 participants who have experienced acute coronary syndrome in the previous 6 months from a National Health Service Hospital. Consenting participants will be randomly allocated in equal numbers to one of three study groups: i) usual care, ii) usual care plus text-only behaviour change technique-based intervention or iii) usual care plus text + visual behaviour change technique-based intervention. The primary outcome will be the change in intention to phone an ambulance immediately with symptoms of acute coronary syndrome ≥15-minute duration, assessed using two randomized series of eight scenarios representing varied symptoms before and after delivery of the interventions or control condition (usual care). Funding granted January 2014. DISCUSSION: Positive results changing intentions would lead to a randomized controlled trial of the behaviour change intervention in clinical practice, assessing patient delay in the event of actual symptoms. TRIAL REGISTRATION: Registered at ClinicalTrials.gov: NCT02820103.

Achieving Good Outcomes for Asthma Living (GOAL): mixed methods feasibility and pilot cluster randomised controlled trial of a practical intervention for eliciting, setting and achieving goals for adults with asthma.

BACKGROUND: Despite being a core component of self-management, goal setting is rarely used in routine care. We piloted a primary care, nurse-led intervention called Achieving Good Outcomes for Asthma Living (GOAL) for adults with asthma. Patients were invited to identify and prioritise their goals in preparation for discussing and negotiating an action/coping plan with the nurse at a routine asthma review. METHODS: The 18-month mixed methods feasibility cluster pilot trial stratified and then randomised practices to deliver usual care (UC) or a goal-setting intervention (GOAL). Practice asthma nurses and adult patients with active asthma were invited to participate. The primary outcome was asthma-specific quality of life. Semi-structured interviews with a purposive patient sample (n = 14) and 10 participating nurses explored GOAL perception. The constructs of normalisation process theory (NPT) were used to analyse and interpret data. RESULTS: Ten practices participated (five in each arm), exceeding our target of eight. However, only 48 patients (target 80) were recruited (18 in GOAL practices). At 6 months post-intervention, the difference in mean asthma-related quality of life (mAQLQ) between intervention and control was 0.1 (GOAL 6.20: SD 0.76 (CI 5.76-6.65) versus UC 6.1: SD 0.81 (CI 5.63-6.57)), less than the minimal clinically important difference (MCID) of 0.5. However, change from baseline was stronger in the intervention group: at 6 months the change in the emotions sub-score was 0.8 for intervention versus 0.2 for control. Costs were higher in the intervention group by £22.17. Routine review with goal setting was considered more holistic, enhancing rapport and enabling patients to become active rather than passive participants in healthcare. However, time was a major barrier for nurses, who admitted to screening out patient goals they believed were unrelated to asthma. CONCLUSIONS: The difference in AQLQ score from baseline is larger in the intervention arm than the control, indicating the intervention may have impact if appropriately strengthened. The GOAL intervention changed the review dynamic and was well received by patients, but necessitated additional time, which was problematic in the confines of the traditional nurse appointment. Modification to recruitment methods and further development of the intervention are needed before proceeding to a definitive cluster randomised controlled trial. TRIAL REGISTRATION: ISRCTN18912042 . Registered on 26 June 2012.

Identifying components in consent information needed to support informed decision making about trial participation: An interview study with women managing cancer.

BACKGROUND: Research governance requires patients give informed consent to participate in clinical trials. However, there are concerns that consent information may not support patient participation decisions. This study investigates the utility of consent information in supporting women's trial participation decisions when receiving treatment for cancer. DESIGN: An interview study with women receiving cancer treatments at a medical oncology outpatient clinic in Yorkshire (UK). All women over 18 years, not admitted to a hospital ward and who had currently or previously been invited to take part in a trial were invited to take part in the study over a three month period. Interviews were audio-tape recorded, transcribed and analysed using thematic analysis. RESULTS: Of those eligible (n = 41), 21 women with breast (n = 11), ovarian (n = 8) and endometrial (n = 2) cancer participated (mean age = 57 years). Eighteen had made at least one trial decision and three were considering taking part in a trial. Findings are synthesised under two analytical themes: 1) Influence of the cancer and cancer treatment context on decision making for trial participation; and 2) Experiences of the consenting process and their influence on decision making. CONCLUSIONS: Designing trial information to represent explicitly the trial participation decision as being between standard care and study-related care options is more likely to effectively support patients in making informed decisions between standard care treatments and taking part in a trial.

Framing Options as Choice or Opportunity: Does the Frame Influence Decisions?

OBJECTIVE: Health professionals must enable patients to make informed decisions about health care choices through unbiased presentation of all options. This study examined whether presenting the decision as "opportunity" rather than "choice" biased individuals' preferences in the context of trial participation for cancer treatment. METHODS: Self-selecting healthy women (N = 124) were randomly assigned to the following decision frames: opportunity to take part in the trial (opt-in), opportunity to be removed from the trial (opt-out), and choice to have standard treatment or take part in the trial (choice). The computer-based task required women to make a hypothetical choice about a real-world cancer treatment trial. The software presented the framed scenario, recorded initial preference, presented comprehensive and balanced information, traced participants' use of information during decision making, and recorded final decision. A posttask paper questionnaire assessed perceived risk, attitudes, subjective norm, perceived behavioral control, and satisfaction with decision. RESULTS: Framing influenced women's immediate preferences. Opportunity frames, whether opt-in or opt-out, introduced a bias as they discouraged women from choosing standard treatment. Using the choice frame avoided this bias. The opt-out opportunity frame also affected women's perceived social norm; women felt that others endorsed the trial option. The framing bias was not present once participants had had the opportunity to view detailed information on the options within a patient decision aid format. There were no group differences in information acquisition and final decisions. Sixteen percent changed their initial preference after receiving full information. CONCLUSIONS: A "choice" frame, where all treatment options are explicit, is less likely to bias preferences. Presentation of full information in parallel, option-by-attribute format is likely to "de-bias" the decision frame. Tailoring of information to initial preferences would be ill-advised as preferences may change following detailed information.

Consensus on items and quantities of clinical equipment required to deal with a mass casualties big bang incident: a national Delphi study.

BACKGROUND: Major short-notice or sudden impact incidents, which result in a large number of casualties, are rare events. However health services must be prepared to respond to such events appropriately. In the United Kingdom (UK), a mass casualties incident is when the normal response of several National Health Service organizations to a major incident, has to be supported with extraordinary measures. Having the right type and quantity of clinical equipment is essential, but planning for such emergencies is challenging. To date, the equipment stored for such events has been selected on the basis of local clinical judgment and has evolved without an explicit evidence-base. This has resulted in considerable variations in the types and quantities of clinical equipment being stored in different locations. This study aimed to develop an expert consensus opinion of the essential items and minimum quantities of clinical equipment that is required to treat 100 people at the scene of a big bang mass casualties event. METHODS: A three round modified Delphi study was conducted with 32 experts using a specifically developed web-based platform. Individuals were invited to participate if they had personal clinical experience of providing a pre-hospital emergency medical response to a mass casualties incident, or had responsibility in health emergency planning for mass casualties incidents and were in a position of authority within the sphere of emergency health planning. Each item's importance was measured on a 5-point Likert scale. The quantity of items required was measured numerically. Data were analyzed using nonparametric statistics. RESULTS: Experts achieved consensus on a total of 134 items (54%) on completion of the study. Experts did not reach consensus on 114 (46%) items. Median quantities and interquartile ranges of the items, and their recommended quantities were identified and are presented. CONCLUSIONS: This study is the first to produce an expert consensus on the items and quantities of clinical equipment that are required to treat 100 people at the scene of a big bang mass casualties event. The findings can be used, both in the UK and internationally, to support decision makers in the planning of equipment for such incidents.

Goal-setting intervention in patients with active asthma: protocol for a pilot cluster-randomised controlled trial.

BACKGROUND: Supporting self-management behaviours is recommended guidance for people with asthma. Preliminary work suggests that a brief, intensive, patient-centred intervention may be successful in supporting people with asthma to participate in life roles and activities they value. We seek to assess the feasibility of undertaking a cluster-randomised controlled trial (cRCT) of a brief, goal-setting intervention delivered in the context of an asthma review consultation. METHODS/DESIGN: A two armed, single-blinded, multi-centre, cluster-randomised controlled feasibility trial will be conducted in UK primary care. Randomisation will take place at the practice level. We aim to recruit a total of 80 primary care patients with active asthma from at least eight practices across two health boards in Scotland (10 patients per practice resulting in ~40 in each arm). Patients in the intervention arm will be asked to complete a novel goal-setting tool immediately prior to an asthma review consultation. This will be used to underpin a focussed discussion about their goals during the asthma review. A tailored management plan will then be negotiated to facilitate achieving their prioritised goals. Patients in the control arm will receive a usual care guideline-based review of asthma. Data on quality of life, asthma control and patient confidence will be collected from both arms at baseline and 3 and 6 months post-intervention. Data on health services resource use will be collected from all patient records 6 months pre- and post-intervention. Semi-structured interviews will be carried out with healthcare staff and a purposive sample of patients to elicit their views and experiences of the trial. The outcomes of interest in this feasibility trial are the ability to recruit patients and healthcare staff, the optimal method of delivering the intervention within routine clinical practice, and acceptability and perceived utility of the intervention among patients and staff. TRIAL REGISTRATION: ISRCTN18912042.

Empowering change: realist evaluation of a Scottish Government programme to support normal birth.

BACKGROUND: midwife-led care has consistently been found to be safe and effective in reducing routine childbirth interventions and improving women's experience of care. Despite consistent UK policy support for maximising the role of the midwife as the lead care provider for women with healthy pregnancies, implementation has been inconsistent and the persistent use of routine interventions in labour has given rise to concern. In response the Scottish Government initiated Keeping Childbirth Natural and Dynamic (KCND), a maternity care programme that aimed to support normal birth by implementing multiprofessional care pathways and making midwife-led care for healthy pregnant women the national norm. AIM: the evaluation was informed by realist evaluation. It aimed to explore and explain the ways in which the KCND programme worked or did not work in different maternity care contexts. METHODS: the evaluation was conducted in three phases. In phase one semi-structured interviews and focus groups were conducted with key informants to elicit the programme theory. At phase two, this theory was tested using a multiple case study approach. Semi-structured interviews and focus groups were conducted and a case record audit was undertaken. In the final phase the programme theory was refined through analyses and interpretation of the data. SETTING AND PARTICIPANTS: the setting for the evaluation was NHS Scotland. In phase one, 12 national programme stakeholders and 13 consultant midwives participated. In phase two case studies were undertaken in three health boards; overall 73 participants took part in interviews or focus groups. A case record audit was undertaken of all births in Scotland during one week in two consecutive years before and after pathway implementation. FINDINGS: government and health board level commitment to, and support of, the programme signalled its importance and facilitated change. Consultant midwives tailored change strategies, using different approaches in response to the culture of care and inter-professional relationships within contexts. In contexts where practice was already changing KCND was seen as validating and facilitating. In areas where a more medical culture existed there was strong resistance to change from midwives and medical staff and robust implementation strategies were required. Overall the pathways appeared to enable midwives to achieve change. KEY CONCLUSIONS: our study highlighted the importance of those involved in a change programme working across levels of hierarchy within an organisation and from the macro-context of national policy and institutions to the meso-context of regional health service delivery and the micro-context of practitioner's experiences of providing care. The assumptions and propositions that inform programmes of change, which are often left at a tacit level and unexamined by those charged with implementing them, were made explicit. This examination illuminated the roles of the three key change mechanisms adopted in the KCND programme - appointment of consultant midwives as programme champions, multidisciplinary care pathways, and midwife-led care. It revealed the role of the commitment mechanism, which built on the appointment of the local change champions. The analysis indicated that the process of change, despite these clear mechanisms, needed to be adapted to local contexts and responses to the implementation of KCND. IMPLICATIONS FOR PRACTICE: initial formative evaluation should be conducted prior to development of complex healthcare programmes to ensure that (1) the interventions will address the changes required, (2) key stakeholders who may support or resist change are identified, and (3) appropriate facilitation strategies are developed tailored to context.