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.

Surgical trainee experience and opinion of robotic surgery in surgical training and vision for the future: a snapshot study of pan-specialty surgical trainees.

BACKGROUND:  Robotic surgery is well established across multiple surgical specialities in the United Kingdom (UK) and Republic of Ireland (ROI). We aimed to elucidate current surgical trainee experience of and attitudes to robotic surgery in a surgical training programme across the UK and ROI to determine the future role of robotic surgery in international surgical training programmes. Methods: A pan-specialty trainee cross-sectional study was performed on behalf of the Association of Surgeons in Training (ASiT) using mixed-methodology. Round 1: a digital questionnaire was disseminated to all ASiT members. Round 2: 'live-polling' was performed prior to and following the Robotic Surgery plenary session convened at the ASiT 2020 International Conference (Birmingham). Data analysis was performed using a combination of quantitative and qualitative methods. RESULTS:  Three hundred and four responses were analysed (n = 244 digital questionnaire, n = 60 live-polling). Overall, 73.8% (n = 180) of trainees would value greater access to robotic surgery training. 73.4% (n = 179) believed that robotic surgery was important for the future of their desired specialty and 77.2% (n = 156) believed it should be incorporated into formal surgical training. Qualitative analysis identified that trainees believe that robotic training should have a formal role in surgical training. Perceived disadvantages of robotic surgery experience in surgical training included expense and the current impact of consultant robotic learning curves on training. CONCLUSION:  Current surgical trainees desire greater access to robotic surgery in surgical training. Robotic surgery is developing an increasing role in current surgical practice and it is important that it is introduced in a timely, evidence-based fashion to surgical trainees at an appropriate stage of training.

Australian community pharmacists' perceptions of public health before the COVID-19 pandemic.

BACKGROUND: Consensus is lacking regarding delivery of public health services in community pharmacy. OBJECTIVE: The objective of this study was to explore pharmacists' perspectives on public health initiatives in community practice. METHOD: Australian community pharmacists were randomly sampled to participate in face-to-face, semi-structured interviews to explore public health definitions and perceptions. KEY FINDINGS: Nine pharmacists participated early 2020, pre-COVID-19. Mean interview duration was 23 min. Results revealed little distinction between individual and public health services. Barriers to service provision were lack of time, remuneration, training, standards and privacy. Enablers opposed barriers, namely accessibility, improved funding, education, standardised services and consulting rooms. CONCLUSION: Improved clarity is required regarding the role that community pharmacists can assume in provision of public health.

Bullying and undermining behaviours in surgery: A qualitative study of surgical trainee experiences in the United Kingdom (UK) & Republic of Ireland (ROI).

BACKGROUND: Bullying and undermining (B/U) behaviours are documented in the international surgical workplace. This study is the largest assessment of prevalence of B/U behaviours within UK & ROI surgical training to date. MATERIALS AND METHODS: UK & ROI surgical trainees were electronically surveyed in July 2017. The survey was open for one month and sent to all registered trainees at Core and Specialty level by the Joint Committee on Surgical Training (JCST) along with email and social media dissemination by the Association of Surgeons in Training (ASiT) and the British Orthopaedic Trainees Association (BOTA). A consensus session on the topic was conducted at the ASiT Conference in Edinburgh in March 2018. Standards for reporting of Qualitative Research were followed. RESULTS: 1412 responses were received (26.6% response rate). All training regions, grades and specialties were represented. 60% of trainees (n = 837) reported witnessing or experiencing B/U behaviours in the surgical workplace. The most common reports related to sexism; 42% (n = 568) reported witnessing or experiencing sexist language/attitudes in the workplace. This was reported more by female respondents (66% compared to 27% male). 21% (n = 291) and 13% (n = 180) reported witnessing or personally experiencing racist and homophobic language or attitudes respectively. Consultants were identified as the most frequent perpetrators. The surgical wards or theatres were the most frequently reported areas that trainees either witnessed or experienced B/U behaviours. Of those trainees who had reported a personal experience of B/U behaviours (n = 344), 20% described their experiences of reporting as negative or very negative. 48.1% of respondents felt that surgery as a whole had a moderate, high or very high degree of a concern about B/U behaviours. CONCLUSION: B/U behaviours are prevalent in the surgical domain. Urgent action is required to eradicate this unacceptable behaviour. A cross-specialty, intercollegiate response is required to tackle this issue and improve the working culture in surgery for all.

Consensus recommendations on balancing educational opportunities and service provision in surgical training: Association of Surgeons in Training Delphi qualitative study.

BACKGROUND: Ensuring the highest quality of surgical training remains a challenge as demands on health service provision rise. This study aimed to explore the differences and potential conflicts between service provision and dedicated training activity provided by surgical trainees, and recommend solutions. METHODS: Participants were drawn from the Association of Surgeons in Training (ASiT) national council. Nominal Group Technique (NGT) was employed by members of the ASiT executive addressing 3 key domains (1) defining differences between training and service tasks, (2) impact of service-provision on training and (3) ways to improve training. A two-round Delphi process was conducted via electronic survey to ASiT council. Consensus was considered achieved for any statement where 80% or more of respondents indicated agreement. RESULTS: 47 statements were generated through NGT which were put to the Delphi process. Consensus was reached on a total of 24/47 statements. Educational or training tasks were identified as being activities which progressed a trainee's skill set, could be tailored to a trainee's own ability, and involved acting as a trainer to more junior colleagues. The negative impact of excess service provision included training quality, trainee mental health, and surgical trainee recruitment. Potential measures to improve training included increasing hospital staffing and resources, protected training times, trainee-specific or competency-based learning and training or incentivising trainers. CONCLUSION: This trainee-based study provides several consensus recommendations on the characteristics that define surgical training and how a balance between service provision and training can potentially be achieved. Policy makers and health systems may be guided by these to ensure high quality training and a satisfied workforce.

Disease outcomes and nodal recurrence in patients with papillary thyroid cancer and lateral neck nodal metastases.

BACKGROUND: The prognostic influence of lateral neck nodal metastases present at the time of diagnosis of papillary thyroid cancer (PTC) remains controversial. This study aims to document disease outcomes and nodal recurrence rates in such patients. METHODS: Patients with PTC and lateral neck nodal metastases who underwent concurrent total thyroidectomy, central and lateral compartment neck dissection between 2000 and 2010 were identified from the prospectively maintained surgical databases of The University of Sydney and University of Wisconsin Endocrine Surgical Units. Disease outcomes and nodal recurrence rates were compared at 12 months post-operatively and in longer-term follow-up. RESULTS: During this 11-year period, 121 patients were identified. Mean age was 45 years; 58% were female and 98% underwent post-operative radioactive iodine ablation. At a median follow-up of 31 months (range 12-140), there were no disease-specific deaths and disease-free survival (defined by stimulated serum thyroglobulin (Tg) < 2.0 µg/L, negative clinical and radiological examination) was 66%. Of the 50 patients with persistently elevated Tg measured 12 months post-operatively, 15 developed clinical lateral neck nodal recurrence. All have undergone re-operative surgery. Elevated stimulated Tg at 12 months post-operatively and a nodal ratio of >30% were significantly associated with an increased risk of lateral neck nodal recurrence. CONCLUSION: With total thyroidectomy, formal compartmental neck dissection and radioactive iodine treatment, disease-free survival can be achieved in the majority of patients with PTC and synchronous lateral neck nodal metastases. A persistently elevated Tg post-operatively and a high ratio of metastatic nodes identify patients at increased risk of locoregional recurrence.