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BackgroundThe DNA-damage immune-response (DDIR) signature is an immune-driven gene expression signature retrospectively validated as predicting response to anthracycline-based therapy. This feasibility study prospectively evaluates the use of this assay to predict neoadjuvant chemotherapy response in early breast cancer.MethodsThis feasibility study assessed the integration of a novel biomarker into clinical workflows. Tumour samples were collected from patients receiving standard of care neoadjuvant chemotherapy (FEC + /−taxane and anti-HER2 therapy as appropriate) at baseline, mid- and post-chemotherapy. Baseline DDIR signature scores were correlated with pathological treatment response. RNA sequencing was used to assess chemotherapy/response-related changes in biologically linked gene signatures.ResultsDDIR signature reports were available within 14 days for 97.8% of 46 patients (13 TNBC, 16 HER2 + ve, 27 ER + HER2-ve). Positive scores predicted response to treatment (odds ratio 4.67 for RCB 0-1 disease (95% CI 1.13–15.09, P = 0.032)). DDIR positivity correlated with immune infiltration and upregulated immune-checkpoint gene expression.ConclusionsThis study validates the DDIR signature as predictive of response to neoadjuvant chemotherapy which can be integrated into clinical workflows, potentially identifying a subgroup with high sensitivity to anthracycline chemotherapy. Transcriptomic data suggest induction with anthracycline-containing regimens in immune restricted, “cold” tumours may be effective for immune priming.Trial registrationNot applicable (non-interventional study). CRUK Internal Database Number 14232.

Background 300 million operations and procedures are performed annually across the world, all of which require a patient’s informed consent. No standardised measure of the consent process exists in current clinical practice. We aimed to define a core outcome set for informed consent for therapy. Methods The core outcome set was developed in accordance with a predefined research protocol and the Core OutcoMes in Effectiveness Trials (COMET) methodology comprising systematic review, qualitative semi structured interviews, a modified Delphi process and consensus webinars to ratify outcomes for inclusion in the final core outcome set. (Registration— https://www.comet-initiative.org/Studies/Details/1024 ). Participants from all key stakeholder groups took part in the process, including patients and the public, healthcare practitioners and consent researchers. Results 36 outcome domains were synthesised through systematic review and organised into a consent taxonomy. 41 semi-structured interviews were performed with all consent stakeholders groups. 164 participants from all stakeholder groups across 8 countries completed Delphi Round 1 and 125 completed Round 2. 11 outcomes met the ‘consensus in’ criteria. 6 met ‘consensus in’ all stakeholder groups and were included directly in the final core outcome set. 5 remaining outcomes meeting ‘consensus in’ were ratified over two consensus webinars. 9 core outcomes were included in the final core outcome set: Satisfaction with the quality and amount of information, Patient feeling that there was a choice, Patient feeling that the decision to consent was their own, Confidence in the decision made, Satisfaction with communication, Trust in the clinician, Patient satisfaction with the consent process, Patient rated adequacy of time and opportunity to ask questions. Conclusion This international mixed-methods qualitative study is the first of its kind to define a core outcome set for informed consent for intervention. It defines what outcomes are of importance to key stakeholders in the consent process and is a forward step towards standardising future consent research.

Background The concept of informed consent is fundamental to medical practice. Shortcomings in the process can lead to patient complaints, litigation, unmet expectations and poor outcomes. Consent research has focused on developing tools to improve patient recall and understanding. However, the definitions, methods of measurement and timing of measurement vary widely across the studies that have been done. Although a Cochrane review has reported that many of these interventions appear to work, the high level of heterogeneity in outcome reporting prevents the identification of those interventions that work best and why they do so. It is also not clear which outcomes are most important to each party involved in the consent process and why. Methods/design This project will develop a core outcome set for assessing the effects of interventions aimed at improving informed consent for surgery and other invasive procedures for adult patients with the capacity to consent for themselves. We will conduct a systematic review of the qualitative and quantitative literature to identify outcomes used to date in consent research and map these into domains. A series of semi-structured key stakeholder interviews will also be used to identify relevant outcomes. These processes will produce a list of potential outcomes for assessing the effects of interventions to improve consent, which will be refined through an international Delphi survey and consensus webinars involving key stakeholders to produce the core outcome set. Discussion The ICONS study aims to develop a core outcome set for use in trials and reviews of interventions designed to improve the informed consent process for surgery and other invasive procedures. Our aim is that this core outcome set will reduce the level of selection and reporting bias in consent research and help clinicians to compare tools to improve consent.

IntroductionResilience can be difficult to conceptualise and little is known about resilience in medical doctors.AimsThis systematic review discusses the existing literature on influences on resilience levels of medical doctors.MethodsThe bibliographic databases PubMed, MEDLINE, EMBASE and PsycINFO were searched from 2008 to November 2018 using keyword search terms resilience* AND (“medical physician*” OR doctor* OR surgeon* OR medical trainee* or clinician*).ResultsTwenty-four studies were deemed eligible for inclusion. A narrative synthesis was performed. The following influences on resilience in doctors were identified: demographics, personality factors, organisational or environmental factors, social support, leisure activities, overcoming previous adversity and interventions to improve resilience.ConclusionsResilience is not limited to a doctor’s own personal resource. Published studies also highlight the influence of other modifiable factors.

Purpose of the studyThe aim of this study was to measure resilience, coping and professional quality of life in doctors.Study designA cross-sectional study using an online questionnaire in a single National Health Service trust, including both primary and secondary care doctors.Results283 doctors were included. Mean resilience was 68.9, higher than population norms. 100 (37%) doctors had high burnout, 194 (72%) doctors had high secondary traumatic stress and 64 (24%) had low compassion satisfaction. Burnout was positively associated with low resilience, low compassion satisfaction, high secondary traumatic stress and more frequent use of maladaptive coping mechanisms, including self-blame, behavioural disengagement and substance use. Non-clinical issues in the workplace were the main factor perceived to cause low resilience in doctors.ConclusionsDespite high levels of resilience, doctors had high levels of burnout and secondary traumatic stress. Doctors suffering from burnout were more likely to use maladaptive coping mechanisms. As doctors already have high resilience, improving personal resilience further may not offer much benefit to professional quality of life. A national study of professional Quality of Life, Coping And REsilience, which we are proposing to undertake, will for the first time assess the UK and Ireland medical workforce in this regard and guide future targeted interventions to improve professional quality of life.

300 million operations and procedures are performed annually across the world, all of which require a patient's informed consent. No standardised measure of the consent process exists in current clinical practice. We aimed to define a core outcome set for informed consent for therapy. The core outcome set was developed in accordance with a predefined research protocol and the Core OutcoMes in Effectiveness Trials (COMET) methodology comprising systematic review, qualitative semi structured interviews, a modified Delphi process and consensus webinars to ratify outcomes for inclusion in the final core outcome set. (Registration--https://www.comet-initiative.org/Studies/Details/1024). Participants from all key stakeholder groups took part in the process, including patients and the public, healthcare practitioners and consent researchers. 36 outcome domains were synthesised through systematic review and organised into a consent taxonomy. 41 semi-structured interviews were performed with all consent stakeholders groups. 164 participants from all stakeholder groups across 8 countries completed Delphi Round 1 and 125 completed Round 2. 11 outcomes met the 'consensus in' criteria. 6 met 'consensus in' all stakeholder groups and were included directly in the final core outcome set. 5 remaining outcomes meeting 'consensus in' were ratified over two consensus webinars. 9 core outcomes were included in the final core outcome set: Satisfaction with the quality and amount of information, Patient feeling that there was a choice, Patient feeling that the decision to consent was their own, Confidence in the decision made, Satisfaction with communication, Trust in the clinician, Patient satisfaction with the consent process, Patient rated adequacy of time and opportunity to ask questions. This international mixed-methods qualitative study is the first of its kind to define a core outcome set for informed consent for intervention. It defines what outcomes are of importance to key stakeholders in the consent process and is a forward step towards standardising future consent research.

Objective To determine if senior doctors’ parking habits and skills are associated with clinical specialty and, if so, whether observation of junior doctors’ parking could provide guidance in choice of specialty.Design Covert observational study.Setting Pass-card controlled consultants’ car park (parking lot), December 2009.Participants 103 consultants entering the car park on three consecutive mornings.Main outcome measures The outcomes were specialty and sex of the consultants, manner of approaching the barrier (pass-card ready or not), and time taken to park, exit the vehicle, and walk to a designated point.Results Approaches to the barrier and parking were recorded for 103 consultants (79 men, 24 women): 28 anaesthetists (22 men, six women), 29 physicians (internists, 18 men, 11 women), 14 radiologists (nine men, five women), and 32 surgeons (30 men, two women). The manner of approaching the barrier (card ready) differed by specialty but not by sex. The total time taken to park (seconds) differed significantly between specialties: surgery (median 68, interquartile range 61-71 seconds), anaesthesia (82, 76-91), radiology (86, 70-103), and general medicine (112, 96-136). The time taken to park was overall longer among women, but this was explained by their specialty (men and women matched by specialty did not differ).Conclusions The total time taken to park and manner of approaching the barrier to gain entry to the car park differed across specialties. Surgical consultants were fastest, followed by consultant anaesthetists and consultant radiologists, with physicians slowest. Sex was not an influencing factor. If reproducible in studies of a similar nature the “barrier method” could allow for a low cost means of guiding junior doctors in career selection.

How one design firm integrated the scientific process of value engineering (VE) into its normal design decision-making process is explored. VE benefits both the owner and design team in several ways.

The need to identify appropriate value indices is discussed and how these indices might be utilized in the measurement of facility designs is explored. A methodology that deals with many value indices is necessary to effectively measure and achieve quality in a complex system.

Post-occupancy value engineering (VE) is discussed. Among other things, post-occupancy value engineering aims to test the performance of original project VE recommendations.