Challenges and solutions to returning to clinical training after research: a multidisciplinary survey of integrated academic trainees in West Yorkshire, United Kingdom.

BACKGROUND: Time out of clinical training can impact medical trainees' skills, competence and confidence. Periods of Out of Programme for Research (OOPR) are often much longer than other approved mechanisms for time of out training. The aim of this survey study was to explore the challenges of returning to clinical training following OOPR, and determine potential solutions. METHODS: All current integrated academic training (IAT) doctors at the University of Leeds (United Kingdom) and previous IAT trainees undertaking OOPR in the local region (West Yorkshire, United Kingdom)(n = 53) were invited to complete a multidisciplinary survey. RESULTS: The survey was completed by 33 participants (62% response rate). The most relevant challenges identified were completing the thesis whilst transitioning back to clinical work, the rapid transition between full-time research and clinical practice, a diminished confidence in clinical abilities and isolation from colleagues. Potential solutions included dedicated funds allocated for the renewal of lapsed skills, adequate notice of the clinical rotation to which trainees return, informing clinical supervisors about the OOPR trainee returning to practice and a mandatory return to standard clinical days. CONCLUSIONS: Addressing these issues has the potential to improve the trainee experience and encourage future trainees to take time out of training for research activities.

Trial of remote continuous versus intermittent NEWS monitoring after major surgery (TRaCINg): a feasibility randomised controlled trial.

BACKGROUND: Despite medical advances, major surgery remains high risk with up to 44% of patients experiencing postoperative complications. Early recognition of postoperative complications is crucial in reducing morbidity and preventing long-term disability. The current standard of care is intermittent manual vital signs monitoring, but new wearable remote monitors offer the benefits of continuous vital signs monitoring without limiting the patient's mobility. The aim of this study was to evaluate the feasibility, acceptability and clinical outcomes of continuous remote monitoring after major surgery. METHODS: The study was a randomised, controlled, unblinded, parallel group, feasibility trial. Adult patients undergoing elective major surgery were randomly assigned to receive continuous remote monitoring and normal National Early Warning Score (NEWS) monitoring (intervention group) or normal NEWS monitoring alone (control group). Continuous remote monitoring was achieved using the SensiumVitals® wireless patch which is worn on the patient's chest and monitors heart rate, respiratory rate and temperature continuously, and alerts the nurse when there is deviation from pre-set physiological norms. Feasibility was assessed by evaluating recruitment rate, adherence to protocol and randomisation and the amount of missing data. Clinical outcomes included time to antibiotics in cases of sepsis, length of hospital stay, number of critical care admissions and rate of hospital readmission within 30 days of discharge. RESULTS: One hundred and thirty-six patients were randomised between October 2018 and April 2019: 67 to the control group and 69 to the intervention group. Recruitment was completed prior to the 12 month target with a high rate of eligibility and consent. Missing data was limited only to questionnaire responses; no participants were lost to follow-up and only one participant was withdrawn due to loss of capacity. The number of patients classed as 'drop-out' due to design (8.1%) were less than anticipated, and there were no participants who crossed over into the alternative trial allocation group. Seventeen participants in the intervention group (28%) did not adhere to the monitoring protocol. No formal comparisons between arms was undertaken; however, participants had fewer unplanned critical care admissions (1 versus 5) and had a shorter average length of hospital stay (11.6 days (95% confidence interval 9.5-13.7 days) versus 16.2 days (95% confidence interval 11.3-21.2 days)) in the continuous vital signs monitoring group. The time taken to receive antibiotics in cases of sepsis was similar in both arms. A cost-utility analysis indicated that the remote monitoring system was cost-saving when compared to standard NEWS monitoring alone. CONCLUSIONS: It is feasible to perform a large-scale randomised controlled trial of continuous remote monitoring after major surgery. Progression to a definitive multicentre randomised controlled trial would be appropriate, taking consideration of factors, such as patient adherence, that might mask the potential benefit of additional monitoring. TRIAL REGISTRATION: ISRCTN registry with study ID ISRCTN16601772 . Registered 30 August 2017.

Research waste in surgical randomized controlled trials.

BACKGROUND: Research waste is a major challenge for evidence-based medicine. It implicates misused resources and increased risks for research participants. The aim of this study was to quantify constituent components of waste in surgical RCTs and explore targets for improvement. METHODS: ClinicalTrials.gov was searched for RCTs registered between January 2011 and December 2012 using the keyword 'surgery'. The primary outcome was research waste, defined as non-publication, inadequate reporting or presence of an avoidable design limitation. Serial systematic searches of PubMed and Scopus databases were performed to determine publication status. Adequacy of reporting was assessed using the CONSORT checklist. Avoidable design limitations were evaluated according to the presence of bias and/or the absence of a cited systematic review of the literature. RESULTS: Of 5617 registered RCTs, 304 met all eligibility criteria. Overall, 259 of 304 (85·2 per cent) demonstrated at least one feature of waste. Of these, 221 (72·7 per cent) were published in a peer-reviewed journal and 219 were accessible for full-text review. Only 73 of 131 (55·7 per cent) RCTs with a pharmacological intervention and 24 of 88 (27 per cent) with a non-pharmacological intervention were reported adequately, and 159 of 219 (72·6 per cent) demonstrated an avoidable design limitation. Multicentre (odds ratio 0·31, 95 per cent c.i. 0·11 to 0·88) and externally funded (OR 0·35, 0·15 to 0·82) RCTs were less associated with research waste. CONCLUSION: This study identified a considerable burden of research waste in surgical RCTs. Future initiatives should target improvements in single-centre, poorly supported RCTs.

ANTECEDENTES: El despilfarro en investigación es uno de los mayores retos para la medicina basada en la evidencia. Conlleva mala utilización de los recursos y aumento de los riesgos para los participantes en las investigaciones. El objetivo de este trabajo fue cuantificar los componentes que conforman este despilfarro en los ensayos aleatorizados y controlados (randomised controlled trials, RCTs) del ámbito quirúrgico y explorar los aspectos clave de mejora. MÉTODOS: Se realizó una búsqueda de los RCTs registrados en la base de datos ClinicalTrials.gov entre enero de 2011 y diciembre de 2012, utilizando la palabra clave cirugía. La variable primaria fue el despilfarro en investigación, definido como la no publicación, el informe inadecuado o la presencia de debilidades del diseño evitables. Para determinar el estado de las publicaciones, se realizaron búsquedas sistemáticas en las bases de datos PubMed y Scopus. La adecuación del informe se evaluó usando la lista de verificación CONSORT. Las debilidades del diseño evitables se evaluaron de acuerdo con la presencia de sesgo y/o la ausencia de citación en revisiones sistemáticas publicadas en la literatura. RESULTADOS: De los 5.617 RCTs registrados, 304 cumplieron con los criterios de elegibilidad. De ellos, 259/304 (85%) cumplieron al menos una de las características de despilfarro. De estos, 221 (73%) se publicaron en una revista con peer review y 219 eran accesibles a texto completo. Únicamente 73/131 (56%) RCTs con una intervención farmacológica y 24/88 (27%) con una intervención no farmacológica presentaban un informe adecuado, y 159/219 (73%) se demostró una debilidad del diseño evitable. Los RCTs multicéntricos (OR: 0,31; i.c. del 95%: 0,11 a 0,88) y con financiación externa (OR: 0,35; i.c. del 95%: 0,15 a 0,82) se asociaron con menos despilfarro de investigación. CONCLUSIÓN: Este estudio constató una carga considerable de despilfarro en investigación en los RCTs quirúrgicos. Se deberían promover iniciativas de mejora, especialmente dirigidas a los RCTs realizados en un solo centro y con menos financiación.

Trial of Remote Continuous versus Intermittent NEWS monitoring after major surgery (TRaCINg): protocol for a feasibility randomised controlled trial.

BACKGROUND: Despite medical advances, major surgery remains high risk. Up to 44% of patients experience postoperative complications, which can have huge impacts for patients and the healthcare system. Early recognition of postoperative complications is crucial in reducing morbidity and preventing long-term disability. The current standard of care is intermittent manual vital signs monitoring, but new wearable remote monitors offer the benefits of continuous vital signs monitoring without limiting the patient's mobility. The aim of this study is to evaluate the feasibility, acceptability and clinical impacts of continuous remote monitoring after major surgery. METHODS: The study is a randomised, controlled, unblinded, parallel group, feasibility trial. Adult patients undergoing elective major surgery will be invited to participate if they have the capacity to provided informed, written consent and do not have a cardiac pacemaker or an allergy to adhesives. Participants will be randomly assigned to receive continuous remote monitoring and normal National Early Warning Score (NEWS) monitoring (intervention group) or normal NEWS monitoring alone (control group). Continuous remote monitoring will be achieved using the SensiumVitals® wireless patch which is worn on the patient's chest and monitors heart rate, respiratory rate and temperature continuously and alerts the nurse when there is deviation from pre-set physiological norms. Participants will be followed up throughout their hospital admission and for 30 days after discharge. Feasibility will be assessed by evaluating recruitment rate, adherence to protocol and randomisation, and the amount of missing data. The acceptability of the patch to nursing staff and patients will be assessed using questionnaires and interviews. Clinical outcomes will include time to antibiotics in cases of sepsis, length of hospital stay, number of critical care admissions and rate of readmission within 30 days of discharge. DISCUSSION: Early detection and treatment of complications minimises the need for critical care, improves patient outcomes, and produces significant cost savings for the healthcare system. Remote continuous monitoring systems have the potential to allow earlier detection of complications, but evidence from the literature is mixed. Demonstrating significant benefit over intermittent monitoring to offset the practical and economic implications of continuous monitoring requires well-controlled studies in high-risk populations to demonstrate significant differences in clinical outcomes; this feasibility trial seeks to provide evidence of how best to conduct such a confirmatory trial. TRIAL REGISTRATION: This study is listed on the ISRCTN registry with study ID ISRCTN16601772.

The impact of continuous versus intermittent vital signs monitoring in hospitals: A systematic review and narrative synthesis.

BACKGROUND: Continuous vital signs monitoring on general hospital wards may allow earlier detection of patient deterioration and improve patient outcomes. This systematic review will assess if continuous monitoring is practical outside of the critical care setting, and whether it confers any clinical benefit to patients. METHODS: MEDLINE®, MEDLINE® In-Process, EMBASE, CINAHL and The Cochrane Library were searched for articles that evaluated the clinical or non-clinical outcomes of continuous vital signs monitoring in adults outside of the critical care setting. The protocol was registered with PROSPERO (CRD42017058098). FINDINGS: Twenty-four studies met the inclusion criteria and reported outcomes on a total of 40,274 patients and 59 ward staff in nine countries. The majority of studies showed benefits in terms of critical care use and length of hospital stay. Larger studies were more likely to demonstrate clinical benefit, particularly critical care use and length of hospital stay. Three studies showed cost-effectiveness. Barriers to implementation included nursing and patient satisfaction and the burden of false alerts. CONCLUSIONS: Continuous vital signs monitoring outside the critical care setting is feasible and may provide a benefit in terms of improved patient outcomes and cost efficiency. Large, well-controlled studies in high-risk populations are required to evaluate the clinical benefit of continuous monitoring systems.

Patient attitudes towards remote continuous vital signs monitoring on general surgery wards: An interview study.

BACKGROUND: Vital signs monitoring is used to identify deteriorating patients in hospital. The most common tool for vital signs monitoring is an early warning score, although emerging technologies allow for remote, continuous patient monitoring. A number of reviews have examined the impact of continuous monitoring on patient outcomes, but little is known about the patient experience. This study aims to discover what patients think of monitoring in hospital, with a particular emphasis on intermittent early warning scores versus remote continuous monitoring, in order to inform future implementations of continuous monitoring technology. METHODS: Semi-structured interviews were undertaken with 12 surgical inpatients as part of a study testing a remote continuous monitoring device. All patients were monitored with both an early warning score and the new device. Interviews were audio-recorded, transcribed verbatim and analysed using thematic analysis. FINDINGS: Patients can see the value in remote, continuous monitoring, particularly overnight. However, patients appreciate the face-to-face aspect of early warning score monitoring as it allows for reassurance, social interaction, and gives them further opportunity to ask questions about their medical care. CONCLUSION: Early warning score systems are widely used to facilitate detection of the deteriorating patient. Continuous monitoring technologies may provide added reassurance. However, patients value personal contact with their healthcare professionals and remote monitoring should not replace this. We suggest that remote monitoring is best introduced in a phased manner, and initially as an adjunct to usual care, with careful consideration of the patient experience throughout.

Strengths and limitations of early warning scores: A systematic review and narrative synthesis.

BACKGROUND: Early warning scores are widely used to identify deteriorating patients. Whilst their ability to predict clinical outcomes has been extensively reviewed, there has been no attempt to summarise the overall strengths and limitations of these scores for patients, staff and systems. This review aims to address this gap in the literature to guide improvements for the optimization of patient safety. METHODS: A systematic review was conducted of MEDLINE®, PubMed, CINAHL and The Cochrane Library in September 2016. The citations and reference lists of selected studies were reviewed for completeness. Studies were included if they evaluated vital signs monitoring in adult human subjects. Studies regarding the paediatric population were excluded, as were studies describing the development or validation of monitoring models. A narrative synthesis of qualitative, quantitative and mixed- methods studies was undertaken. FINDINGS: 232 studies met the inclusion criteria. Twelve themes were identified from synthesis of the data: Strengths of early warning scores included their prediction value, influence on clinical outcomes, cross-specialty application, international relevance, interaction with other variables, impact on communication and opportunity for automation. Limitations included their sensitivity, the need for practitioner engagement, the need for reaction to escalation and the need for clinical judgment, and the intermittent nature of recording. Early warning scores are known to have good predictive value for patient deterioration and have been shown to improve patient outcomes across a variety of specialties and international settings. This is partly due to their facilitation of communication between healthcare workers. There is evidence that the prediction value of generic early warning scores suffers in comparison to specialty-specific scores, and that their sensitivity can be improved by the addition of other variables. They are also prone to inaccurate recording and user error, which can be partly overcome by automation. CONCLUSIONS: Early warning scores provide the right language and environment for the timely escalation of patient care. They are limited by their intermittent and user-dependent nature, which can be partially overcome by automation and new continuous monitoring technologies, although clinical judgment remains paramount.

The prognostic significance of tumour-stroma ratio in oestrogen receptor-positive breast cancer.

BACKGROUND: A high percentage of stroma predicts poor survival in triple-negative breast cancers but is diminished in studies of unselected cases. We determined the prognostic significance of tumour-stroma ratio (TSR) in oestrogen receptor (ER)-positive male and female breast carcinomas. METHODS: TSR was measured in haematoxylin and eosin-stained tissue sections (118 female and 62 male). Relationship of TSR (cutoff 49%) to overall survival (OS) and relapse-free survival (RFS) was analysed. RESULTS: Tumours with ≥49% stroma were associated with better survival in female (OS P=0.008, HR=0.2-0.7; RFS P=0.006, HR=0.1-0.6) and male breast cancer (OS P=0.005, HR=0.05-0.6; RFS P=0.01, HR=0.87-5.6), confirmed in multivariate analysis. CONCLUSIONS: High stromal content was related to better survival in ER-positive breast cancers across both genders, contrasting data in triple-negative breast cancer and highlighting the importance of considering ER status when interpreting the prognostic value of TSR.