Reporting of health-related quality of life in emergency laparotomy trials: a systematic review and narrative synthesis.

PURPOSE: Emergency laparotomy is associated with high morbidity for the surgical patient. Understanding patients' health-related quality of life after their surgery is important to enhance the informed consent process, and to enable the evaluation and improvement of surgical care. This review aims to summarise the use of health-related quality of life tools in clinical trials involving patients undergoing emergency laparotomy. METHODS: A systematic review was undertaken of the scientific literature published in the MEDLINE® and PubMed databases between January 2011 and July 2021. A narrative synthesis approach was chosen to synthesise the diverse range of studies in a structured manner. All included papers were evaluated using the Cochrane Collaboration's tool for assessing risk of bias. RESULTS: Eleven studies were selected for inclusion. Most of the studies had a low risk of bias. Two of the studies used health-related quality of life as the primary outcome measure. A variety of health-related quality of life measurement tools were used; the EQ-5D tool was the most popular questionnaire. Protocol adherence was dependent on the length of time which had elapsed after emergency surgery. CONCLUSION: There are many perceived challenges to collecting health-related quality of life data in the emergency surgery setting. Many of these can be offset with progressive trial designs. There is a need for further research in the systematic development of patient-reported outcomes for use in emergency surgery.

Robotic complete mesocolic excision with central vascular ligation for right colonic tumours - a propensity score-matching study comparing with standard laparoscopy.

BACKGROUND: Laparoscopic complete mesocolic excision (CME) of the right colon with central vascular ligation (CVL) is a technically demanding procedure. This study retrospectively evaluated the feasibility, safety and oncological outcomes of the procedure when performed using the da Vinci® robotic system. METHODS: A prospective case series was collected over 3 years for patients with right colonic cancers treated by standardized robotic CME with CVL using the superior mesenteric vessels first approach. The CME group was compared to a 2 : 1 propensity score-matched non-CME group who had conventional laparoscopic right colectomy with D2 nodal dissection. Primary outcomes were total lymph node harvest and length of specimen. Secondary outcomes were operative time, postoperative complications, and disease-free and overall survival. RESULTS: The study included 120 patients (40 in the CME group and 80 in the non-CME group). Lymph node yield was higher (29 versus 18, P = 0.006), the specimen length longer (322 versus 260 mm, P = 0.001) and median operative time was significantly longer (180 versus 130 min, P < 0.001) with robotic CME versus laparoscopy, respectively. Duration of hospital stay was longer with robotic CME, although not significantly (median 6 versus 5 days, P = 0.088). There were no significant differences in R0 resection rate, complications, readmission rates and local recurrence. A trend in survival benefit with robotic CME for disease-free (P = 0.0581) and overall survival (P = 0.0454) at 3 years was documented. CONCLUSION: Robotic CME with CVL is feasible and, although currently associated with a longer operation time, it provides good specimen quality, higher lymph node yield and acceptable morbidity, with a disease-free survival advantage.

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.

Dynamics of picosecond laser ablation for surgical treatment of colorectal cancer.

Endoluminal surgery for the treatment of colorectal neoplasia is typically carried out using electrocautery tools which imply limited precision and the risk of harm through collateral thermal damage to the adjacent healthy tissue. As a potential alternative, we present the successful colonic epithelial laser ablation by means of picosecond laser pulses. Laser ablation studies performed in ex-vivo colon tissue result in cavities with comparable thickness to early stage colorectal cancers. The corresponding histology sections exhibit only minimal collateral damage to the surrounding tissue and the depth of the ablation can be controlled precisely by means of the pulse energy. High-speed imaging has been used for the first time to visualize picosecond laser ablation of cancerous tissue in a clinically relevant model. This information was correlated with histopathology and optical surface profilometry revealing the dynamic nature of the laser tissue interaction and the need for temporal or spatial separation of pulses for optimum efficacy with regards to tissue removal. Overall, the application of picosecond laser pulses to ablate endoluminal bowel lesions demonstrates significantly improved precision and reduced thermal damage to the adjacent tissue in comparison to conventional procedures and hence will enable more precise surgical treatment of cancers.

Patient education about recovery after colorectal surgery: systematic scoping review.

AIM: Enhanced recovery after surgery (ERAS) protocols aim to optimize recovery through a series of evidence-based recommendations. A key component of ERAS is the provision of patient education. Whilst the recommendation for this is strong, the evidence to inform its format, timing and delivery is unclear. The aim of this review was to describe previous educational interventions used to improve recovery after colorectal surgery and to explore opportunities for future research. METHODS: A systematic scoping review was performed. MEDLINE and Embase databases were searched between 1 January 1990 and 12 February 2020. Studies which described or assessed the effectiveness of a patient education or information resource to improve recovery after colorectal surgery were eligible. Outcomes of interest included the format, timing and delivery of interventions, as well as key features of intervention and study design. A narrative synthesis of data was produced through a process of charting and summarizing key results. RESULTS: A total of 1298 papers were inspected, and 11 were eligible for inclusion. Five papers were reports of randomized controlled trials, and others reported a mix of non-randomized and qualitative studies. The design of educational interventions included audio-visual resources (n = 3), smartphone device applications (n = 3) and approaches to facilitate person-to-person counselling (n = 5). Most of the counselling interventions reported positive outcomes (mainly in length of hospital stay), whereas the other types reported mixed results. Patients and the public were seldom involved as collaborators in the design of interventions. CONCLUSIONS: Patient education is generally advantageous, but there is insufficient evidence to optimize its design and delivery in the setting of colorectal surgery.

Establishing core outcome sets for gastrointestinal recovery in studies of postoperative ileus and small bowel obstruction: protocol for a nested methodological study.

INTRODUCTION: Gastrointestinal recovery describes the restoration of normal bowel function in patients with bowel disease. This may be prolonged in two common clinical settings: postoperative ileus and small bowel obstruction. Improving gastrointestinal recovery is a research priority but researchers are limited by variation in outcome reporting across clinical studies. This protocol describes the development of core outcome sets for gastrointestinal recovery in the contexts of postoperative ileus and small bowel obstruction. METHOD: An international Steering Group consisting of patient and clinician representatives has been established. As overlap between clinical contexts is anticipated, both outcome sets will be co-developed and may be combined to form a common output with disease-specific domains. The development process will comprise three phases, including definition of outcomes relevant to postoperative ileus and small bowel obstruction from systematic literature reviews and nominal-group stakeholder discussions; online-facilitated Delphi surveys via international networks; and a consensus meeting to ratify the final output. A nested study will explore if the development of overlapping outcome sets can be rationalized. DISSEMINATION AND IMPLEMENTATION: The final output will be registered with the Core Outcome Measures in Effectiveness Trials initiative. A multi-faceted, quality improvement campaign for the reporting of gastrointestinal recovery in clinical studies will be launched, targeting international professional and patient groups, charitable organizations and editorial committees. Success will be explored via an updated systematic review of outcomes 5 years after registration of the core outcome set.

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.

Avoiding, diagnosing and treating well leg compartment syndrome after pelvic surgery.

BACKGROUND: Patients undergoing prolonged pelvic surgery may develop compartment syndrome of one or both lower limbs in the absence of direct trauma or pre-existing vascular disease (well leg compartment syndrome). This condition may have devastating consequences for postoperative recovery, including loss of life or limb, and irreversible disability. METHODS: These guidelines represent the collaboration of a multidisciplinary group of colorectal, vascular and orthopaedic surgeons, acting on behalf of their specialty associations in the UK and Ireland. A systematic analysis of the available peer-reviewed literature was undertaken to provide an evidence base from which these guidelines were developed. RESULTS: These guidelines encompass the risk factors (both patient- and procedure-related), diagnosis and management of the condition. Key recommendations for the adoption of perioperative strategies to facilitate prevention and effective treatment of well leg compartment syndrome are presented. CONCLUSION: All surgeons who carry out abdominopelvic surgical procedures should be aware of well leg compartment syndrome, and instigate policies within their own institution to reduce the risk of this potentially life-changing complication.

Disseminating technology in global surgery.

BACKGROUND: Effective dissemination of technology in global surgery is vital to realize universal health coverage by 2030. Challenges include a lack of human resource, infrastructure and finance. Understanding these challenges, and exploring opportunities and solutions to overcome them, are essential to improve global surgical care. METHODS: This review focuses on technologies and medical devices aimed at improving surgical care and training in low- and middle-income countries. The key considerations in the development of new technologies are described, along with strategies for evaluation and wider dissemination. Notable examples of where the dissemination of a new surgical technology has achieved impact are included. RESULTS: Employing the principles of frugal and responsible innovation, and aligning evaluation and development to high scientific standards help overcome some of the challenges in disseminating technology in global surgery. Exemplars of effective dissemination include low-cost laparoscopes, gasless laparoscopic techniques and innovative training programmes for laparoscopic surgery; low-cost and versatile external fixation devices for fractures; the LifeBox pulse oximeter project; and the use of immersive technologies in simulation, training and surgical care delivery. CONCLUSION: Core strategies to facilitate technology dissemination in global surgery include leveraging international funding, interdisciplinary collaboration involving all key stakeholders, and frugal scientific design, development and evaluation.

The role of robotics in colorectal surgery.

Robotic surgery is safe and feasible offering many potential advantages to the colorectal surgeon.

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.

Socioeconomic differences in selection for liver resection in metastatic colorectal cancer and the impact on survival.

BACKGROUND: Socioeconomic inequalities in colorectal cancer (CRC) survival are well recognised. The aim of this study was to describe the impact of socioeconomic deprivation on survival in patients with synchronous CRC liver-limited metastases, and to investigate if any survival inequalities are explained by differences in liver resection rates. METHODS: Patients in the National Bowel Cancer Audit diagnosed with CRC between 2010 and 2016 in the English National Health Service were included. Linked Hospital Episode Statistics data were used to identify the presence of liver metastases and whether a liver resection had been performed. Multivariable random-effects logistic regression was used to estimate the odds ratio (OR) of liver resection by Index of Multiple Deprivation (IMD) quintile. Cox-proportional hazards model was used to compare 3-year survival. RESULTS: 13,656 patients were included, of whom 2213 (16.2%) underwent liver resection. Patients in the least deprived IMD quintile were more likely to undergo liver resection than those in the most deprived quintile (adjusted OR 1.42, 95% confidence interval (CI) 1.18-1.70). Patients in the least deprived quintile had better 3-year survival (least deprived vs. most deprived quintile, 22.3% vs. 17.4%; adjusted hazard ratio (HR) 1.20, 1.11-1.30). Adjusting for liver resection attenuated, but did not remove, this effect. There was no difference in survival between IMD quintile when restricted to patients who underwent liver resection (adjusted HR 0.97, 0.76-1.23). CONCLUSIONS: Deprived CRC patients with synchronous liver-limited metastases have worse survival than more affluent patients. Lower rates of liver resection in more deprived patients is a contributory factor.

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.

Postoperative ileus following major colorectal surgery.

BACKGROUND: Postoperative ileus (POI) is characterized by delayed gastrointestinal recovery following surgery. Current knowledge of pathophysiology, clinical interventions and methodological challenges was reviewed to inform modern practice and future research. METHODS: A systematic search of MEDLINE and Embase databases was performed using search terms related to ileus and colorectal surgery. All RCTs involving an intervention to prevent or reduce POI published between 1990 and 2016 were identified. Grey literature, non-full-text manuscripts, and reanalyses of previous RCTs were excluded. Eligible articles were assessed using the Cochrane tool for assessing risk of bias. RESULTS: Of 5614 studies screened, 86 eligible articles describing 88 RCTs were identified. Current knowledge of pathophysiology acknowledges neurogenic, inflammatory and pharmacological mechanisms, but much of the evidence arises from animal studies. The most common interventions tested were chewing gum (11 trials) and early enteral feeding (11), which are safe but of unclear benefit for actively reducing POI. Others, including thoracic epidural analgesia (8), systemic lidocaine (8) and peripheral µ antagonists (5), show benefit but require further investigation for safety and cost-effectiveness. CONCLUSION: POI is a common condition with no established definition, aetiology or treatment. According to current literature, minimally invasive surgery, protocol-driven recovery (including early feeding and opioid avoidance strategies) and measures to avoid major inflammatory events (such as anastomotic leak) offer the best chances of reducing POI.

The timing of liver resection in patients with colorectal cancer and synchronous liver metastases: a population-based study of current practice and survival.

AIM: There is uncertainty regarding the optimal sequence of surgery for patients with colorectal cancer (CRC) and synchronous liver metastases. This study was designed to describe temporal trends and inter-hospital variation in surgical strategy, and to compare long-term survival in a propensity score-matched analysis. METHOD: The National Bowel Cancer Audit dataset was used to identify patients diagnosed with primary CRC between 1 January 2010 and 31 December 2015 who underwent CRC resection in the English National Health Service. Hospital Episode Statistics data were used to identify those with synchronous liver-limited metastases who underwent liver resection. Survival outcomes of propensity score-matched groups were compared. RESULTS: Of 1830 patients, 270 (14.8%) underwent a liver-first approach, 259 (14.2%) a simultaneous approach and 1301 (71.1%) a bowel-first approach. The proportion of patients undergoing either a liver-first or simultaneous approach increased over the study period from 26.8% in 2010 to 35.6% in 2015 (P < 0.001). There was wide variation in surgical approach according to hospital trust of diagnosis. There was no evidence of a difference in 4-year survival between the propensity score-matched cohorts according to surgical strategy: bowel first vs simultaneous [hazard ratio (HR) 0.92 (95% CI: 0.80-1.06)] or bowel first vs liver first [HR 0.99 (95% CI: 0.82-1.19)]. CONCLUSION: There is evidence of wide variation in surgical strategy in dealing with CRC and synchronous liver metastases. In selected patients, the simultaneous and liver-first strategies have comparable long-term survival to the bowel-first approach.

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.