Digital health technology-specific risks for medical malpractice liability.

Medical professionals are increasingly required to use digital technologies as part of care delivery and this may represent a risk for medical error and subsequent malpractice liability. For example, if there is a medical error, should the error be attributed to the clinician or the artificial intelligence-based clinical decision-making system? In this article, we identify and discuss digital health technology-specific risks for malpractice liability and offer practical advice for the mitigation of malpractice risk.

Real-world use of workplace based assessments in surgical training: A UK nationwide cross-sectional exploration of trainee perspectives and consensus recommendations from the Association of Surgeons in Training.

BACKGROUND: Despite widespread uptake, the utility of Workplace Based Assessments (WBAs) is disputed and evidence underpinning their use is largely based upon their completion in ideal conditions, rather than the real-world setting. AIM: To ascertain the real-world usage of WBAs, as perceived by UK surgical trainees. MATERIALS AND METHODS: An anonymous online questionnaire conducted nationally via the Association of Surgeons in Training (ASiT). Evaluation of 906 completed trainee responses, across all surgical specialties and training levels, employed mixed methods to interpret quantitative and qualitative data. RESULTS: The sample permitted a 3.0% confidence level with acceptable internal consistency (Cronbach's alpha 0.755). Formative use was supported by 72.5% and summative use was rejected by almost as many (66.3%). WBA use was perceived to deviate markedly from that recommended by the Joint Committee on Surgical Training (JCST). Significant misuse was identified and elements perceived as inaccurate appear commonplace across the breadth of surgical specialties. Inaccurate completion was acknowledged by 89.6% of respondents and some trainers appear complicit, 147 individuals (16.2%) having reported this to trainers, 40.9% aware of 'unobserved sign-off', and 33.6% aware of 'password disclosure' by trainers. Furthermore, a majority of trainees felt the Annual Review of Competency Progression (ARCP) respected WBA quantity above quality (55.4%), and a third felt pressure to overstate the number completed (32.0%). Reasons for misuse appeared largely centred upon time restraints, lack of engagement and a will to achieve the required targets for career progression. 1.5 CONCLUSIONS: This study demonstrates that UK surgical trainees perceive that most trainees deviate from guidance in their use of WBAs. This is worrying in both the apparent frequency and nature of misuse and somewhat undermines existing evidence for their role in surgical training. Trainees perceive that required numbers of WBAs are too high, that training programmes fail to encourage their use as formative assessments, and that there is a lack of engagement by many trainees and trainers. We present consensus recommendations from ASiT for the improvement of WBA use in UK surgical training.

What is the clinical value of mHealth for patients?

Despite growing interest from both patients and healthcare providers, there is little clinical guidance on how mobile apps should be utilized to add value to patient care. We categorize apps according to their functionality (e.g. preventative behavior change, digital self-management of a specific condition, diagnostic) and discuss evidence for effectiveness from published systematic reviews and meta-analyses and the relevance to patient care. We discuss the limitations of the current literature describing clinical outcomes from mHealth apps, what FDA clearance means now (510(k)/de novo FDA clearance) and in the future. We discuss data security and privacy as a major concern for patients when using mHealth apps. Patients are often not involved in the development of mobile health guidelines, and professionals' views regarding high-quality health apps may not reflect patients' views. We discuss efforts to develop guidelines for the development of safe and effective mHealth apps in the US and elsewhere and the role of independent app reviews sites in identifying mHealth apps for patient care. There are only a small number of clinical scenarios where published evidence suggests that mHealth apps may improve patient outcomes.

Surgical trainees' experience of pregnancy, maternity and paternity leave: a cross-sectional study.

BACKGROUND: Internationally, supporting surgical trainees during pregnancy, maternity and paternity leave is essential for trainee well-being and for retention of high-calibre surgeons, regardless of their parental status. This study sought to determine the current experience of surgical trainees regarding pregnancy, maternity and paternity leave. METHODS: A cross-sectional anonymised electronic voluntary survey of all surgical trainees working in the UK and Ireland was distributed via the Association of Surgeons in Training and the British Orthopaedic Trainees' Association. RESULTS: There were 876 complete responses, of whom 61.4% (n=555) were female. 46.5% (258/555) had been pregnant during surgical training. The majority (51.9%, n=134/258) stopped night on-call shifts by 30 weeks' gestation. The most common reason for this was concerns related to tiredness and maternal health. 41% did not have rest facilities available on night shifts. 27.1% (n=70/258) of trainees did not feel supported by their department during pregnancy, and 17.1% (n=50/258) found the process of arranging maternity leave difficult or very difficult. 61% (n=118/193) of trainees felt they had returned to their normal level of working within 6 months of returning to work after maternity leave, while a significant minority took longer. 25% (n=33/135) of trainees found arranging paternity leave difficult or very difficult, and the most common source of information regarding paternity leave was other trainees. CONCLUSION: Over a quarter of surgical trainees felt unsupported by their department during pregnancy, while a quarter of male trainees experience difficulty in arranging paternity leave. Efforts must be made to ensure support is available in pregnancy and maternity/paternity leave.

Surgical safety checklist training: a national study of undergraduate medical and nursing student teaching, understanding and influencing factors.

INTRODUCTION: Use of the WHO surgical safety checklist is consistently recognised to reduce harm caused by human error during the perioperative period. Inconsistent engagement is considered to contribute to persistence of surgical Never Events in the National Health Service. Most medical and nursing graduates will join teams responsible for the perioperative care of patients, therefore appropriate undergraduate surgical safety training is needed. AIMS: To investigate UK medical and nursing undergraduate experience of the surgical safety checklist training. METHODS: An eight-item electronic questionnaire was distributed electronically to 32 medical schools and 72 nursing schools. Analysis was conducted for the two cohorts, and responses from final year students were included. RESULTS: 87/224 (38.8%) of medical students received teaching on the surgical safety checklist, compared with 380/711 (52.0%) of nursing students. 172/224 (76.8%) of medical students and 489/711 (66.9%) of nursing students understood its purpose and 8/224 (3.6%) medical students and 54/711 (7.4%) nursing students reported never being included in the Time Out. After adjusting for confounding factors, provision of formal teaching in checklist use increased understanding significantly (OR 50.39 (14.07 to 325.79, P<0.001)), as did routine student involvement in time outs (OR 5.72 (2.36 to 14.58, P<0.001)). DISCUSSION: Knowledge of perioperative patient safety systems and the ability to participate in safety protocols are important skills that should be formally taught at the undergraduate level. Results of this study show that UK undergraduate surgical safety checklist training does not meet the minimum standards set by the WHO.

Cross-sectional study of the financial cost of training to the surgical trainee in the UK and Ireland.

OBJECTIVES: Applications for surgical training have declined over the last decade, and anecdotally the costs of training at the expense of the surgical trainee are rising. We aimed to quantify the costs surgical trainees are expected to cover for postgraduate training. DESIGN: Prospective, cross-sectional, questionnaire-based study. SETTING/PARTICIPANTS: A non-mandatory online questionnaire for UK-based trainees was distributed nationally. A similar national questionnaire was distributed for Ireland, taking into account differences between the healthcare systems. Only fully completed responses were included. RESULTS: There were 848 and 58 fully completed responses from doctors based in the UK and Ireland, respectively. Medical students in the UK reported a significant increase in debt on graduation by 55% from £17 892 (2000-2004) to £27 655 (2010-2014) (p<0.01). 41% of specialty trainees in the UK indicated that some or all of their study budget was used to fund mandatory regional teaching. By the end of training, a surgical trainee in the UK spends on average £9105 on courses, £5411 on conferences and £4185 on exams, not covered by training budget. Irish trainees report similarly high costs. Most trainees undertake a higher degree during their postgraduate training. The cost of achieving the mandatory requirements for completion of training ranges between £20 000 and £26 000 (dependent on specialty), except oral and maxillofacial surgery, which is considerably higher (£71 431). CONCLUSIONS: Medical students are graduating with significantly larger debt than before. Surgical trainees achieve their educational requirements at substantial personal expenditure. To encourage graduates to pursue and remain in surgical training, urgent action is required to fund the mandatory requirements and annual training costs for completion of training and provide greater transparency to inform doctors of what their postgraduate training costs will be. This is necessary to increase diversity in surgery, reduce debt load and ensure surgery remains a popular career choice.

Impact of Surgical Lighting on Intraoperative Safety in Low-Resource Settings: A Cross-Sectional Survey of Surgical Providers.

BACKGROUND: Safe surgery requires high-quality, reliable lighting of the surgical field. Little is reported on the quality or potential safety impact of surgical lighting in low-resource settings, where power failures are common and equipment and resources are limited. METHODS: Members of the Lifebox Foundation created a novel, non-mandatory, 18-item survey tool using an iterative process. This was distributed to surgical providers practicing in low-resource settings through surgical societies and mailing lists. RESULTS: We received 100 complete responses, representing a range of surgical centres from 39 countries. Poor-quality surgical field lighting was reported by 40% of respondents, with 32% reporting delayed or cancelled operations due to poor lighting and 48% reporting electrical power failures at least once per week. Eighty per cent reported the quality of their surgical lighting presents a patient safety risk with 18% having direct experience of poor-quality lighting leading to negative patient outcomes. When power outages occur, 58% of surgeons rely on a backup generator and 29% operate by mobile phone light. Only 9% of respondents regularly use a surgical headlight, with the most common barriers reported as unaffordability and poor in-country suppliers. CONCLUSIONS: In our survey of surgeons working in low-resource settings, a majority report poor surgical lighting as a major risk to patient safety and nearly one-third report delayed or cancelled operations due to poor lighting. Developing and distributing robust, affordable, high-quality surgical headlights could provide an ideal solution to this significant surgical safety issue.

Interval follow up of a 4-day pilot program to implement the WHO surgical safety checklist at a Congolese hospital.

BACKGROUND: The World Health Organisation Surgical Safety Checklist (SSC) improves surgical outcomes and the research question is no longer 'does the SSC work?' but, 'how to make the SSC work?' Evidence for implementation strategies in low-income countries is sparse and existing strategies are heavily based on long-term external support. Short but effective implementation programs are required if widespread scale up is to be achieved. We designed and delivered a four-day pilot SSC training course at a single hospital centre in the Republic of Congo, and evaluated the implementation after one year. We hypothesised that participants would still be using the checklist over 50% of the time. METHOD: We taught the four-day SSC training course at Dolisie hospital in February 2014, and undertook a mixed methods impact evaluation based on the Kirkpatrick model in May 2015. SSC implementation was evaluated using self-reported questionnaire with a 3 point Likert scale to assess six key process measures. Learning, behaviour, organisational change and facilitators and inhibitors to change were evaluated with questionnaires, interviews and focus group discussion. RESULTS: Seventeen individuals participated in the training and seven (40%) were available for impact evaluation at 15 months. No participant had used the SSC prior to training. Over half the participants were following the six processes measures always or most of the time: confirmation of patient identity and the surgical procedure (57%), assessment of difficult intubation risk (72%), assessment of the risk of major blood loss (86%), antibiotic prophylaxis given before skin incision (86%), use of a pulse oximeter (86%), and counting sponges and instruments (71%). All participants reported positive improvements in teamwork, organisation and safe anesthesia. Most participants reported they worked in helpful, supportive and respectful atmosphere; and could speak up if they saw something that might harm a patient. However, less than half felt able to challenge those in authority. CONCLUSION: Our study demonstrates that a 4-day pilot course for SSC implementation resulted in over 50% of participants using the SSC at 15 months, positive changes in learning, behaviour and organisational change, but less impact on hierarchical culture. The next step is to test our novel implementation strategy in a larger hospital setting.

Less than full-time training in surgery: a cross-sectional study evaluating the accessibility and experiences of flexible training in the surgical trainee workforce.

OBJECTIVES: Generational changes in lifestyle expectations, working environments and the feminisation of the medical workforce have seen an increased demand in postgraduate less than full-time training (LTFT). Despite this, concerns remain regarding access to, and information about, flexible training for surgeons. This study aimed to assess the opinions and experiences of LTFT for surgical trainees. DESIGN: Prospective, questionnaire-based cross-sectional study. SETTING/PARTICIPANTS: An electronic, self-administered questionnaire was distributed in the UK and Republic of Ireland through mailing lists via the Association of Surgeons in Training and British Orthopedic Trainee Association. RESULTS: Overall, 876 completed responses were received, representing all grades of trainee across all 10 surgical specialties. Median age was 33 years and 63.4% were female. Of those who had undertaken LTFT, 92.5% (148/160) were female. Most worked 60% of a full-time post (86/160, 53.8%). The reasons for either choosing or considering LTFT were childrearing (82.7%), caring for a dependent (12.6%) and sporting commitments (6.8%). Males were less likely to list childrearing than females (64.9% vs 87.6%; p<0.0001). Only 38% (60/160) found the application process easy and 53.8% (86/160) experienced undermining behaviour from workplace staff as a result of undertaking LTFT. Of all respondents, an additional 53.7% (385/716) would consider LTFT in future; 27.5% of which were male (106/385). Overall, only 9.9% of all respondents rated current LTFT information as adequate. Common sources of information were other trainees (47.3%), educational supervisors (20.6%) and local postgraduate school website (19.5%). CONCLUSIONS: Over half of surgical trainees working LTFT have experienced undermining behaviour as a result of their LTFT. Despite a reported need for LTFT in both genders, this remains difficult to organise, access to useful information is poor and negative attitudes among staff remain. Recommendations are made to provide improved support and information for those wishing to pursue LTFT.

Less Than Full-time Training in surgical specialities: Consensus recommendations for flexible training by the Association of Surgeons in Training.

Changes in lifestyle, career expectations, and working environments, alongside the feminisation of the workforce have resulted in an increased demand for Less Than Full-time Training (LTFT) within surgery. However, provision of and adequacy of flexible training remain variable. It is important that LTFT options are provided to ensure surgery is an attractive and viable career option, and can compete with other specialties to attract and retain the best candidates to maintain high standards of patient care. LTFT options should be readily available to both genders within surgical specialities. Furthermore, improved information for those considering LTFT should be available, locally, regionally and nationally. Training within LTFT posts should be tailored to the training requirements of the individual, in order to achieve the competencies necessary for completion of training. The recommendations set out in this consensus statement should inform the trainee's position and help guide discussions with respect to the provision of LTFT within surgery.

Determining Surgical Complications in the Overweight (DISCOVER): a multicentre observational cohort study to evaluate the role of obesity as a risk factor for postoperative complications in general surgery.

INTRODUCTION: Obesity is increasingly prevalent among patients undergoing surgery. Conflicting evidence exists regarding the impact of obesity on postoperative complications. This multicentre study aims to determine whether obesity is associated with increased postoperative complications following general surgery. METHODS AND ANALYSIS: This prospective, multicentre cohort study will be performed utilising a collaborative methodology. Consecutive adults undergoing open or laparoscopic, elective or emergency, gastrointestinal, bariatric or hepatobiliary surgery will be included. Day case patients will be excluded. The primary end point will be the overall 30-day major complication rate (Clavien-Dindo grade III-V complications). Data will be collected to risk-adjust outcomes for potential confounding factors, such as preoperative cardiac risk. This study will be disseminated through structured medical student networks using established collaborative methodology. The study will be powered to detect a two-percentage point increase in the major postoperative complication rate in obese versus non-obese patients. ETHICS AND DISSEMINATION: Following appropriate assessment, an exemption from full ethics committee review has been received, and the study will be registered as a clinical audit or service evaluation at each participating hospital. Dissemination will take place through national and local research collaborative networks.

Promoting research and audit at medical school: evaluating the educational impact of participation in a student-led national collaborative study.

BACKGROUND: Medical students often struggle to engage in extra-curricular research and audit. The Student Audit and Research in Surgery (STARSurg) network is a novel student-led, national research collaborative. Student collaborators contribute data to national, clinical studies while gaining an understanding of audit and research methodology and ethical principles. This study aimed to evaluate the educational impact of participation. METHODS: Participation in the national, clinical project was supported with training interventions, including an academic training day, an online e-learning module, weekly discussion forums and YouTube® educational videos. A non-mandatory, online questionnaire assessed collaborators' self-reported confidence in performing key academic skills and their perceptions of audit and research prior to and following participation. RESULTS: The group completed its first national clinical study ("STARSurgUK") with 273 student collaborators across 109 hospital centres. Ninety-seven paired pre- and post-study participation responses (35.5%) were received (male = 51.5%; median age = 23). Participation led to increased confidence in key academic domains including: communication with local research governance bodies (p < 0.001), approaching clinical staff to initiate local collaboration (p < 0.001), data collection in a clinical setting (p < 0.001) and presentation of scientific results (p < 0.013). Collaborators also reported an increased appreciation of research, audit and study design (p < 0.001). CONCLUSIONS: Engagement with the STARSurg network empowered students to participate in a national clinical study, which increased their confidence and appreciation of academic principles and skills. Encouraging active participation in collaborative, student-led, national studies offers a novel approach for delivering essential academic training.

Social media and internet driven study recruitment: evaluating a new model for promoting collaborator engagement and participation.

AIMS: A substantial challenge facing multicentre audit and research projects is timely recruitment of collaborators and their study centres. Cost-effective strategies are required and fee-free social media has previously been identified as a potential conduit. We investigated and evaluated the effectiveness of a novel multi-format social media and Internet strategy for targeted recruitment to a national multicentre cohort study. METHODS: Interventions involved a new Twitter account, including weekly live question-and-answer sessions, a new Facebook group page, online YouTube presentations and an information page on a national association website. Link tracking analysis was undertaken using Google Analytics, which was then related to subsequent registration. Social influence was calculated using the proprietary Klout score. RESULTS: Internet traffic analysis identified a total of 1562 unique registration site views, of which 285 originated from social media (18.2%). Some 528 unique registrations were received, with 96 via social media platforms (18.2%). Traffic source analysis identified a separate national association webpage as resulting in the majority of registration page views (15.8%), followed by Facebook (11.9%), Twitter (4.8%) and YouTube (1.5%). A combination of publicity through Facebook, Twitter and the dedicated national association webpage contributed to the greatest rise in registration traffic and accounted for 312 (48%) of the total registrations within a 2-week period. A Twitter 'social influence' (Klout) score of 42/100 was obtained during this period. CONCLUSIONS: Targeted social media substantially aided study dissemination and collaborator recruitment. It acted as an adjunct to traditional methods, accounting for 18.2% of collaborator registration in a short time period with no associated financial costs. We provide a practical model for designing future recruitment campaigns, and recommend Facebook, Twitter and targeted websites as the most effective adjuncts for maximising cost-effective study recruitment.

Health Education England, Local Education and Training Boards (LETBs) and reform of healthcare education: implications for surgical training.

BACKGROUND: National Health Service (NHS) reforms have changed the structure of postgraduate healthcare education and training. With a Government mandate that promotes multi-professional education and training aligned with policy driven initiatives, this article highlights concerns over the impact that these changes may have on surgical training. DISCUSSION: The creation of Health Education England (HEE) and its local education and training boards (LETBs), which are dominated by NHS healthcare providers, should result in greater accountability of employers in workforce planning, enhanced local responsibility and increased transparency of funding allocation. However, these changes may also create a potential poacher-turned-gamekeeper role of employers, who now have responsibility for junior doctors' training. Analysis of LETB membership reveals a dearth of representation of surgeons, who comprise only 2% of board members, with the input of trainees also seemingly overlooked. A lack of engagement with the LETBs by the independent sector is a concern with increasing numbers of training opportunities potentially being lost as a result.The new system also needs to recognise the specific training needs required by the craft specialties given the demands of technical skill acquisition, in particular regarding the provision of simulation training facilities and trainer recognition. However, training budget cuts may result in a disproportionate reduction of funding for surgical training. Surgical training posts will also be endangered, opportunities for out-of-programme experience and research may also decline and further costs are likely to be passed onto the trainee. SUMMARY: Although there are several facets to the recent reforms of the healthcare education and training system that have potential to improve surgical training, concerns need to be addressed. Engagement from the independent sector and further clarification on how the LETBs will be aligned with commissioning services are also required. Surgical training is in danger of taking a back seat to Government mandated priorities. Representation of trainees and surgeons on LETB committees is essential to ensure a surgical viewpoint so that the training needs of the future consultant workforce meet the demands of a 21st century health service.

Discontinuation and non-publication of surgical randomised controlled trials: observational study.

OBJECTIVE: To determine the rate of early discontinuation and non-publication of randomised controlled trials involving patients undergoing surgery. DESIGN: Cross sectional observational study of registered and published trials. SETTING: Randomised controlled trials of interventions in patients undergoing a surgical procedure. DATA SOURCES: The ClinicalTrials.gov database was searched for interventional trials registered between January 2008 and December 2009 using the keyword "surgery". Recruitment status was extracted from the ClinicalTrials.gov database. A systematic search for studies published in peer reviewed journals was performed; if they were not found, results posted on the ClinicalTrials.gov results database were sought. Email queries were sent to trial investigators of discontinued and unpublished completed trials if no reason for the respective status was disclosed. MAIN OUTCOME MEASURES: Trial discontinuation before completion and non-publication after completion. Logistic regression was used to determine the effect of funding source on publication status, with adjustment for intervention type and trial size. RESULTS: Of 818 registered trials found using the keyword "surgery", 395 met the inclusion criteria. Of these, 21% (81/395) were discontinued early, most commonly owing to poor recruitment (44%, 36/81). The remaining 314 (79%) trials proceeded to completion, with a publication rate of 66% (208/314) at a median time of 4.9 (interquartile range 4.0-6.0) years from study completion to publication search. A further 6% (20/314) of studies presented results on ClinicalTrials.gov without a corresponding peer reviewed publication. Industry funding did not affect the rate of discontinuation (adjusted odds ratio 0.91, 95% confidence interval 0.54 to 1.55) but was associated with a lower odds of publication for completed trials (0.43, 0.26 to 0.72). Investigators' email addresses for trials with an uncertain fate were identified for 71.4% (10/14) of discontinued trials and 83% (101/122) of unpublished studies. Only 43% (6/14) and 20% (25/122) replies were received. Email responses for completed trials indicated 11 trials in press, five published studies (four in non-indexed peer reviewed journals), and nine trials remaining unpublished. CONCLUSIONS: One in five surgical randomised controlled trials are discontinued early, one in three completed trials remain unpublished, and investigators of unpublished studies are frequently not contactable. This represents a waste of research resources and raises ethical concerns regarding hidden clinical data and futile participation by patients with its attendant risks. To promote future efficiency and transparency, changes are proposed to research governance frameworks to overcome these concerns.