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.

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.

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.

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.

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.

How do doctors refer to patient-reported outcome measures (PROMS) in oncology consultations?

PURPOSE: We conducted a secondary qualitative analysis of consultations between oncologists and their patients to explore how patient-reported outcome measures (PROMs) data were referred to in the process of (1) eliciting and exploring patients' concerns; (2) making decisions about supportive treatment and (3) making decisions about chemotherapy and other systemic treatments. METHODS: We purposively sampled audio recordings of 18 consultations from the intervention arm and 4 from the attention control arm of a previous UK randomised controlled trial of the feedback of PROMs data to doctors (Velikova et al. in J Clin Oncol 22(4):714-724 [1]). We used a combination of content and conversation analysis to examine how opportunities for discussion of health-related quality of life issues are opened up or closed down within the consultation and explore why this may or may not lead to changes in patient management. FINDINGS: Explicit reference to the PROMs data provided an opportunity for the patient to clarify and further elaborate on the side effects of chemotherapy. High scores on the PROMs data were not explored further if the patient indicated they were not a problem or were not related to the cancer or chemotherapy. Symptomatic treatment was more often offered for problems like nausea, constipation, pain and depression but much less so for fatigue. Doctors discussed fatigue by providing a cause for the fatigue (e.g. the chemotherapy), presenting this as 'something to be expected', minimising its impact or moving on to another topic. Chemotherapy regimens were not changed on the basis of the PROMs data alone, but PROMs data were sometimes used to legitimise changes. CONCLUSIONS: Explicit mention of PROMs data in the consultation may strengthen opportunities for patients to elaborate on their problems, but doctors may not always know how to do this. Our findings have informed the development of a training package to enable doctors to optimise their use of PROMs data within the consultation.

Balancing the presentation of information and options in patient decision aids: an updated review.

BACKGROUND: Standards for patient decision aids require that information and options be presented in a balanced manner; this requirement is based on the argument that balanced presentation is essential to foster informed decision making. If information is presented in an incomplete/non-neutral manner, it can stimulate cognitive biases that can unduly affect individuals' knowledge, perceptions of risks and benefits, and, ultimately, preferences. However, there is little clarity about what constitutes balance, and how it can be determined and enhanced. We conducted a literature review to examine the theoretical and empirical evidence related to balancing the presentation of information and options. METHODS: A literature search related to patient decision aids and balance was conducted on Medline, using MeSH terms and PubMed; this search supplemented the 2011 Cochrane Collaboration's review of patient decision aids trials. Only English language articles relevant to patient decision making and addressing the balance of information and options were included. All members of the team independently screened clusters of articles; uncertainties were resolved by seeking review by another member. The team then worked in sub-groups to extract and synthesise data on theory, definitions, and evidence reported in these studies. RESULTS: A total of 40 articles met the inclusion criteria. Of these, six explained the rationale for balancing the presentation of information and options. Twelve defined "balance"; the definition of "balance" that emerged is as follows: "The complete and unbiased presentation of the relevant options and the information about those options-in content and in format-in a way that enables individuals to process this information without bias". Ten of the 40 articles reported assessing the balance of the relevant decision aid. All 10 did so exclusively from the users' or patients' perspective, using a five-point Likert-type scale. Presenting information in a side-by-side display form was associated with more respondents (ranging from 70% to 96%) judging the information as "balanced". CONCLUSION: There is a need for comparative studies investigating different ways to improve and measure balance in the presentation of information and options in patient decision aids.

Clarifying values: an updated review.

BACKGROUND: Consensus guidelines have recommended that decision aids include a process for helping patients clarify their values. We sought to examine the theoretical and empirical evidence related to the use of values clarification methods in patient decision aids. METHODS: Building on the International Patient Decision Aid Standards (IPDAS) Collaboration's 2005 review of values clarification methods in decision aids, we convened a multi-disciplinary expert group to examine key definitions, decision-making process theories, and empirical evidence about the effects of values clarification methods in decision aids. To summarize the current state of theory and evidence about the role of values clarification methods in decision aids, we undertook a process of evidence review and summary. RESULTS: Values clarification methods (VCMs) are best defined as methods to help patients think about the desirability of options or attributes of options within a specific decision context, in order to identify which option he/she prefers. Several decision making process theories were identified that can inform the design of values clarification methods, but no single "best" practice for how such methods should be constructed was determined. Our evidence review found that existing VCMs were used for a variety of different decisions, rarely referenced underlying theory for their design, but generally were well described in regard to their development process. Listing the pros and cons of a decision was the most common method used. The 13 trials that compared decision support with or without VCMs reached mixed results: some found that VCMs improved some decision-making processes, while others found no effect. CONCLUSIONS: Values clarification methods may improve decision-making processes and potentially more distal outcomes. However, the small number of evaluations of VCMs and, where evaluations exist, the heterogeneity in outcome measures makes it difficult to determine their overall effectiveness or the specific characteristics that increase effectiveness.

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.

Why values elicitation techniques enable people to make informed decisions about cancer trial participation.

BACKGROUND: Decision aids help patients make informed treatment decisions. Values clarification (VC) techniques are part of decision aids that help patients assimilate the information with their personal values. There is little evidence that these techniques contribute to enhanced decision making over and above the provision of good quality information. OBJECTIVES: To assess whether VC techniques are active ingredients in enhancing informed decision making and explain how and why they work. METHODS: Participants were randomly assigned to one of three groups: (i) information only, (ii) information plus implicit task, (iii) information plus explicit task. Thirty healthy women from a UK University participated by making a hypothetical choice between taking part in a clinical trial and having the standard treatment for breast cancer. Verbal protocols were elicited by think-aloud method and content analysed to assess informed decision making; a questionnaire was completed after the decision assessing decision preference, perceptions of decisional conflict and ambivalence. Data were analysed using multivariate statistics. FINDINGS: No participants changed their decision preference as a result of the VC techniques. Women in the explicit VC group evaluated more information in accord with personal values, expressed lower ambivalence, decisional uncertainty and greater clarity of personal values than those in the implicit VC and control groups. Feelings of ambivalence about both options were related to decisional conflict. CONCLUSION: Explicit VC techniques are likely to be active ingredients in decision aids. They work by enabling people to deliberate about the decision information in accord with their personal values, which is associated with a better decision experience.

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.

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.

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.

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.

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.

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.