Development of a core outcome set for informed consent for therapy: An international key stakeholder consensus study.

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.

Activation of a cGAS-STING-mediated immune response predicts response to neoadjuvant chemotherapy in early breast cancer.

BACKGROUND: The 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. METHODS: This 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. RESULTS: DDIR 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. CONCLUSIONS: This 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 REGISTRATION: Not applicable (non-interventional study). CRUK Internal Database Number 14232.

Resilience in medical doctors: a systematic review.

INTRODUCTION: Resilience can be difficult to conceptualise and little is known about resilience in medical doctors. AIMS: This systematic review discusses the existing literature on influences on resilience levels of medical doctors. METHODS: The 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*). RESULTS: Twenty-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. CONCLUSIONS: Resilience is not limited to a doctor's own personal resource. Published studies also highlight the influence of other modifiable factors.

Evaluating interventions for informed consent for surgery (ICONS): Protocol for the development of a core outcome set.

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.

A study of the relationship between resilience, burnout and coping strategies in doctors.

PURPOSE OF THE STUDY: The aim of this study was to measure resilience, coping and professional quality of life in doctors. STUDY DESIGN: A cross-sectional study using an online questionnaire in a single National Health Service trust, including both primary and secondary care doctors. RESULTS: 283 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. CONCLUSIONS: Despite 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.

Illness perception clusters at diagnosis predict psychological distress among women with breast cancer at 6 months post diagnosis.

OBJECTIVE: This study aimed to examine the extent to which illness perceptions and coping strategies among women diagnosed with breast cancer explain psychological distress at diagnosis and at 6 months post diagnosis relative to demographic and illness-related variables. METHODS: Women were recruited to the study shortly after diagnosis. A total of 90 women completed study materials (Illness Perception Questionnaire-Revised, the Cancer Coping Questionnaire and the Hospital Anxiety and Depression Scale) at time 1. The same questionnaires were sent approximately 6 months later to those who had consented at time 1, and completed questionnaires were returned by 72 women. RESULTS: Cluster analysis was used to identify groups of respondents who reported a similar profile of illness perception scores. Regression analysis demonstrated that one of these clusters was more likely to experience psychological distress than the other both at diagnosis and at 6 months post diagnosis. Illness perception cluster membership and positive focus type coping were the most important and consistent predictors of lower psychological distress at diagnosis and at 6 months post diagnosis. CONCLUSIONS: Illness perceptions remained relatively stable over the study period, and therefore we are unable to clarify whether changes in illness cognitions are associated with a corresponding change in psychological symptoms. Future research should evaluate the impact on psychological distress of interventions specifically designed to modify illness cognitions among women with breast cancer.

The barrier method as a new tool to assist in career selection: covert observational study.

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.