Implementation of home 'finger-prick' carcino-embryonic antigen testing for colorectal cancer follow-up - A pilot study of user acceptability.

Aim: Routine carcino-embryonic antigen blood testing is required after colorectal cancer resection, requiring face-to-face appointments. This has workforce implications, and impacts patients' lives. We assessed feasibility and acceptability of self-taken blood tests. Methods: 50 colorectal cancer patients with experience of face-to-face phlebotomy surveillance agreed to self-testing finger-prick kits. Follow-up questionnaires assessed perspectives and preferences. Results: 68% (50/74) of patients agreed to participate. 76% (38/50) successfully completed samples. 62% (29/47) felt it was no worse than their previous experience. Regarding future testing, 47% (22/47) preferred finger-prick testing. 19% (9/47) expressed no preference. This was unaffected by patient age. Qualitative assessment showed difficulties with pain, discomfort, and sample collection, but was more convenient and saved time for patients. Conclusions: Many preferred finger-prick assessment, but some found it challenging, unnecessary or less preferable. This may reduce burden of follow-up blood tests but currently would only be acceptable to a limited patient cohort.

Novel methods to define invasive procedures at the end of life were developed to improve quality of end of life care research: a population-based cohort study in colorectal cancer.

BACKGROUND: Understanding the use of invasive procedures (IPs) at the end of life (EoL) is important to avoid undertreatment and overtreatment, but epidemiologic analysis is hampered by limited methods to define treatment intent and EoL phase. This study applied novel methods to report IPs at the EoL using a colorectal cancer case study. METHODS: An English population-based cohort of adult patients diagnosed between 2013 and 2015 was used with follow-up to 2018. Procedure intent (curative, noncurative, diagnostic) by cancer site and stage at diagnosis was classified by two surgeons independently. Joinpoint regression modeled weekly rates of IPs for 36 subcohorts of patients with incremental survival of 0-36 months. EoL phase was defined by a significant IP rate change before death. Zero-inflated Poisson regression explored associations between IP rates and clinical/sociodemographic variables. RESULTS: Of 87,731 patients included, 41,972 (48%) died. Nine thousand four hundred ninety two procedures were classified by intent (inter-rater agreement 99.8%). Patients received 502,895 IPs (1.39 and 3.36 per person year for survivors and decedents). Joinpoint regression identified significant increases in IPs 4 weeks before death in those living 3-6 months and 8 weeks before death in those living 7-36 months from diagnosis. Seven thousand nine hundred eight (18.8%) patients underwent IPs at the EoL, with stoma formation the most common major procedure. Younger age, early-stage disease, men, lower comorbidity, those receiving chemotherapy, and living longer from diagnosis were associated with IPs. CONCLUSION: Methods to identify and classify IPs at the EoL were developed and tested within a colorectal cancer population. This approach can be now extended and validated to identify potential undertreatment and overtreatment.

Remote assessment of surgical site infection (SSI) using patient-taken wound images: Development and evaluation of a method for research and routine practice.

BACKGROUND/AIM: Clinical assessment of wounds for surgical site infection (SSI) after hospital discharge is challenging and resource intensive. Remote assessment using digital images may be feasible and expedite SSI diagnosis. Acceptable and accurate methods for this process are needed. This study developed and evaluated the feasibility, acceptability and usability of a method for patients to capture standardised wound images for remote wound assessment to detect SSI. MATERIALS AND METHODS: The work was conducted in two phases. Phase I involved: i) a review of literature to identify key components of photography relevant to taking wound images, ii) development of wound photography instructions for patients and a secure process for transmission of images using electronic survey software and iii) pre-testing of the photography instructions and processing method with a sample of 16 patients using cognitive interviews and observations. Phase II involved a prospective cohort study of 89 patients to evaluate the feasibility, acceptability and usability of the remote method following discharge from hospital after surgery. Quality of the images was assessed by three independent clinical reviewers. RESULTS: Some 21 key components for photographing wounds were identified from 11 documents. Of these, 16 were relevant to include in instructions for patients to photograph their wounds. Pre-testing and subsequent iterations improved understanding and ease of use of the instructions and the process for transmitting images. Fifty-two of 89 (58.4%) patients testing the method remotely took an image of their wound(s) and 46/52 (88.5%) successfully transmitted images. When it was possible to ascertain a reason for not taking/transmitting images, this was primarily health problems (n = 7) or lack of time/poor engagement with the study (n = 4) rather than problems relating to technology/competency (n = 2) or practical issues relating to the wound itself (n = 2). Eighty-seven (85.3%) of the 102 images received were evaluated to be of high quality and sufficient to remotely assess SSI by at least two independent reviewers. CONCLUSION: A simple, standardised and acceptable method for patients to take and transmit wound images suitable for remote assessment of SSI has been developed and tested and is now available for use in routine clinical care and research.

NEWS2 in out-of-hospital settings, the ambulance and the emergency department.

As more healthcare is provided in non-hospital settings, it is essential to support clinicians in recognising early signs of clinical deterioration to enable prompt intervention and treatment.There are intuitive reasons why the use of the National Early Warning Score 2 (NEWS2) in out-of-hospital settings may enhance the community response to acute illness by using a common language across healthcare. An additional advantage of the use of NEWS2 in community settings is that it is not disease specific and requires no expensive technology or great expertise to take a full set of observations that can be an indicator of clinical acuity.However, concerns have been expressed as NEWS2 was developed in acute hospital settings that it may not be applicable in community settings; this review shares some of the practical ways that NEWS2 can support clinical practice along with the emerging published evidence.

Using the recommended summary plan for emergency care and treatment (ReSPECT) in care homes: a qualitative interview study.

BACKGROUND: The Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) is an advance care planning process designed to facilitate discussion and documentation of preferences for care in a medical emergency. Advance care planning is important in residential and nursing homes. AIM: To explore the views and experiences of GPs and care home staff of the role of ReSPECT in: (i) supporting, and documenting, conversations about care home residents' preferences for emergency care situations, and (ii) supporting decision-making in clinical emergencies. SETTING/PARTICIPANTS: Sixteen GPs providing clinical care for care home residents and 11 care home staff in the West of England. METHODS: A qualitative research design using semi-structured interviews. RESULTS: Participants' accounts described the ReSPECT process as facilitating person-centred conversations about residents' preferences for care in emergency situations. The creation of personalised scenarios supported residents to consider their preferences. However, using ReSPECT was complex, requiring interactional work to identify and incorporate resident or relative preferences. Subsequent translation of preferences into action during emergency situations also proved difficult in some cases. Care staff played an important role in facilitating and supporting ReSPECT conversations and in translating it into action. CONCLUSIONS: The ReSPECT process in care homes was positive for GPs and care home staff. We highlight challenges with the process, communication of preferences in emergency situations and the importance of balancing detail with clarity. This study highlights the potential for a multi-disciplinary approach engaging care staff more in the process.

Improving the documentation of chaperones during intimate examinations in a surgical admissions unit: A four-stage approach.

BACKGROUND: The General Medical Council (GMC) states that all intimate examinations should have a chaperone offered. Documentation of chaperone identity, or patient's refusal, is essential. OBJECTIVE: This project aimed to improve documentation of chaperones during intimate examination of patients based in a Surgical Admissions Unit (SAU) within a large tertiary hospital in the Southwest of the UK. METHODS: A Plan-Do-Study-Act (PDSA) cycle structure was used. Initial data collection and planning occurred in December 2019. Intervention implementation and analysis occurred from January 2020 to March 2021. Intervention 1 involved presenting results at a clinical governance meeting. Intervention 2 was information posters in the SAU and intervention 3 involved training sessions for nursing staff. Intervention 4 was editing the surgical clerking proforma. RESULTS: Prior to interventions, chaperone identity or patient's refusal was correctly documented only 9.7% (N = 7 out of 72) of the time. Intervention 1 increased this to 34.6%. Following interventions 3 and 4, correct documentation was 25.0% and 28.6% respectively. After intervention 4 correct documentation was at 59.1%. CONCLUSIONS: Initial documentation of chaperones was poor. Interventions 1 to 3 were successful in educating clinicians how to document accurately, but engaging individuals in person was more successful than passive education through posters. Changing the proforma structure was the most successful intervention. This suggests a visual reminder for clinicians at the point of contact with the patient is the most effective way to encourage correct documentation of chaperones, improving patient care and clinical practice.

Urinary Volatile Organic Compound Testing in Fast-Track Patients with Suspected Colorectal Cancer.

Colorectal symptoms are common but only infrequently represent serious pathology, including colorectal cancer (CRC). A large number of invasive tests are presently performed for reassurance. We investigated the feasibility of urinary volatile organic compound (VOC) testing as a potential triage tool in patients fast-tracked for assessment for possible CRC. A prospective, multi-center, observational feasibility study was performed across three sites. Patients referred to NHS fast-track pathways for potential CRC provided a urine sample that underwent Gas Chromatography-Mass Spectrometry (GC-MS), Field Asymmetric Ion Mobility Spectrometry (FAIMS), and Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) analysis. Patients underwent colonoscopy and/or CT colonography and were grouped as either CRC, adenomatous polyp(s), or controls to explore the diagnostic accuracy of VOC output data supported by an artificial neural network (ANN) model. 558 patients participated with 23 (4%) CRC diagnosed. 59% of colonoscopies and 86% of CT colonographies showed no abnormalities. Urinary VOC testing was feasible, acceptable to patients, and applicable within the clinical fast track pathway. GC-MS showed the highest clinical utility for CRC and polyp detection vs. controls (sensitivity = 0.878, specificity = 0.882, AUROC = 0.896) but it is labour intensive. Urinary VOC testing and analysis are feasible within NHS fast-track CRC pathways. Clinically meaningful differences between patients with cancer, polyps, or no pathology were identified suggesting VOC analysis may have future utility as a triage tool.

Safety and transparency in surgical innovation.

Advances in healthcare require safe and transparent innovation. Currently in surgery it can be difficult to identify when innovation is occurring because of inconsistent oversight and reporting. New ways of identifying, monitoring and reporting surgical innovation are called for in order to optimise the process.

Prognostic value of National Early Warning Scores (NEWS2) and component physiology in hospitalised patients with COVID-19: a multicentre study.

BACKGROUND: National Early Warning Scores (NEWS2) are used to detect all-cause deterioration. While studies have looked at NEWS2, the use of virtual consultation and remote monitoring of patients with COVID-19 mean there is a need to know which physiological observations are important. AIM: To investigate the relationship between outcome and NEWS2, change in NEWS2 and component physiology in COVID-19 inpatients. METHODS: A multi-centre retrospective study of electronically recorded, routinely collected physiological measurements between March and June 2020. First and maximum NEWS2, component scores and outcomes were recorded. Areas under the curve (AUCs) for 2-day, 7-day and 30-day mortality were calculated. RESULTS: Of 1263 patients, 26% died, 7% were admitted to intensive care units (ICUs) before discharge and 67% were discharged without ICU. Of 1071 patients with initial NEWS2, most values were low: 50% NEWS2=0-2, 27% NEWS2=3-4, 14% NEWS2=5-6 and 9% NEWS2=7+. Maximum scores were: 14% NEWS2=0-2, 22% NEWS2=3-4, 17% NEWS2=5-6 and 47% NEWS2=7+. Higher first and maximum scores were predictive of mortality, ICU admission and longer length of stay. AUCs based on 2-day, 7-day, 30-day and any hospital mortality were 0.77 (95% CI 0.70 to 0.84), 0.70 (0.65 to 0.74), 0.65 (0.61 to 0.68) and 0.65 (0.61 to 0.68), respectively. The AUCs for 2-day mortality were 0.71 (0.65 to 0.77) for supplemental oxygen, 0.65 (0.56 to 0.73) oxygen saturation and 0.64 (0.56 to 0.73) respiratory rate. CONCLUSION: While respiratory parameters were most predictive, no individual parameter was as good as a full NEWS2, which is an acceptable predictor of short-term mortality in patients with COVID-19. This supports recommendation to use NEWS2 alongside clinical judgement to assess patients with COVID-19.

Removing hospital-based triage from suspected colorectal cancer pathways: the impact and learning from a primary care-led electronic straight-to-test pathway.

BACKGROUND: The 2-week wait referral pathway for suspected colorectal cancer was introduced in England to improve time from referral from a general practitioner (GP) to diagnosis and treatment. Patients are required to be seen by a hospital clinician within 2 weeks if their symptoms meet the criteria set by the National Institute for Health and Care Excellence (NICE) and to start cancer treatment within 62 days. To achieve this, many hospitals have introduced a straight-to-test (STT) strategy requiring hospital-based triage of referrals. We describe the impact and learning from a new pathway which has removed triage and moved the process of requesting tests from hospital to GPs in primary care. METHOD: An electronic STT pathway was introduced allowing GPs to book tests supported by a decision aid based on NICE guidance eliminating the need for a standard referral form or triage process. The hospital identified referrals as being on a cancer pathway and dealt with all ongoing management. Routinely collected cancer data were used to identify time to cancer diagnosis compared with national data RESULTS: 11357 patients were referred via the new pathway over 3 years. Time from referral to diagnosis reduced from 39 to 21 days and led to a dramatic improvement in patients starting treatment within 62 days. Challenges included adapting to a change in referral criteria and developing a robust hospital system to monitor the pathway. CONCLUSION: We have changed the way patients with suspected colorectal cancer are managed within the National Health Service by giving GPs the ability to order tests electronically within a monitored cancer pathway halving time from referral to diagnosis.

The community burden of surgical site infection following elective colorectal resection.

AIM: Surgical site infection (SSI) is common after colorectal surgery. Recent attempts to measure SSI have focused on inpatient SSI and readmissions. This study examined patient-reported SSI at 30 days over 8 years. METHODS: The Health Protection Agency questionnaire was used to prospectively measure 30-day patient-reported SSI in patients undergoing elective colorectal operations between February 2011 and April 2019. Questionnaires were sent by post and followed up with a phone call. Data relating to hospital stay were prospectively recorded on an enhanced recovery database. RESULTS: In all, 80.7% (1268) of 1559 patients responded to the questionnaire with an overall SSI rate of 15.9% (201/1268). The majority of patients who reported SSI presented in the community (66.7%) of whom 65% consulted their general practitioner and 35% saw a community nurse. Patient-reported SSI was validated by a health professional in over 90% of cases. Overall, only 1.5% of readmissions and 2% of ward attendances were due to an isolated wound problem. Patients who developed SSI during their index admission had a longer length of stay (11 days vs. 4 days) but there was no difference in delayed discharge or complications between patients with and without SSI, suggesting that a previously described association between SSI and increased length of stay may be due to observational bias. CONCLUSION: Existing surveillance audits are suboptimal for monitoring SSIs following colorectal surgery as most SSIs present after discharge. There is a need for robust 30-day surveillance with a standardized methodology if comparisons are to be made between units.

Implementation of the National Early Warning Score in patients with suspicion of sepsis: evaluation of a system-wide quality improvement project.

BACKGROUND: The National Early Warning Score (NEWS) was introduced to standardise early warning scores (EWS) in England. It has been recommended that NEWS should be used in pre-hospital care but there is no published evidence that this improves outcomes. In 2015, the West of England Academic Health Science Network region standardised to NEWS across all healthcare settings. Calculation of NEWS was recommended for acutely unwell patients at referral into secondary care. AIM: To evaluate whether implementation of NEWS across a healthcare system affects outcomes, specifically addressing the effect on mortality in patients with suspicion of sepsis (SOS). DESIGN AND SETTING: A quality improvement project undertaken across the West of England from March 2015 to March 2019, with the aim of standardising to NEWS in secondary care and introducing NEWS into community and primary care. METHOD: Data from the national dashboard for SOS for the West of England were examined over time and compared to the rest of England. Quality improvement methodology and statistical process control charts were used to measure improvement. RESULTS: There was a reduction in mortality in the SOS cohort in the West of England, which was not seen in the rest of England over the time period of the project. Admissions did not increase. By March 2019, the West of England had the lowest mortality in the SOS cohort in England. CONCLUSION: To the authors' knowledge, this is the first study demonstrating that use of NEWS in pre-hospital care is associated with improved outcomes in patients with SOS.

Association between National Early Warning Scores in primary care and clinical outcomes: an observational study in UK primary and secondary care.

BACKGROUND: NHS England has mandated use of the National Early Warning Score (NEWS), more recently NEWS2, in acute settings, and suggested its use in primary care. However, there is reluctance from GPs to adopt NEWS/NEWS2. AIM: To assess whether NEWS calculated at the point of GP referral into hospital is associated with outcomes in secondary care. DESIGN AND SETTING: An observational study using routinely collected data from primary and secondary care. METHOD: NEWS values were prospectively collected for 13 047 GP referrals into acute care between July 2017 and December 2018. NEWS values were examined and multivariate linear and logistic regression used to assess associations with process measures and clinical outcomes. RESULTS: Higher NEWS values were associated with faster conveyance for patients travelling by ambulance, for example, median 94 minutes (interquartile range [IQR] 69-139) for NEWS ≥7; median 132 minutes, (IQR 84-236) for NEWS = 0 to 2); faster time from hospital arrival to medical review (54 minutes [IQR 25-114] for NEWS ≥7; 78 minutes [IQR 34-158] for NEWS = 0 to 2); as well as increased length of stay (5 days [IQR 2-11] versus 1 day [IQR 0-5]); intensive care unit admissions (2.0% versus 0.5%); sepsis diagnosis (11.7% versus 2.5%); and mortality, for example, 30-day mortality 12.0% versus 4.1% for NEWS ≥7 versus NEWS = 0 to 2, respectively. On average, for patients referred without a NEWS value (NEWS = NR), most clinical outcomes were comparable with patients with NEWS = 3 to 4, but ambulance conveyance time and time to medical review were comparable with patients with NEWS = 0 to 2. CONCLUSION: This study has demonstrated that higher NEWS values calculated at GP referral into hospital are associated with a faster medical review and poorer clinical outcomes.

Development of a core information set for colorectal cancer surgery: a consensus study.

OBJECTIVE: 'Core information sets' (CISs) represent baseline information, agreed by patients and professionals, to stimulate individualised patient-centred discussions. This study developed a CIS for use before colorectal cancer (CRC) surgery. DESIGN: Three phase consensus study: (1) Systematic literature reviews and patient interviews to identify potential information of importance to patients, (2) UK national Delphi survey of patients and professionals to rate the importance of the information, (3) international consensus meeting to agree on the final CIS. SETTING: UK CRC centres. PARTICIPANTS: Purposive sampling was conducted to ensure CRC centre representation based upon geographical region and caseload volume. Responses were received from 63/81 (78%) centres (90 professionals). Adult patients who had undergone CRC surgery were eligible, and purposive sampling was conducted to ensure representation based on age, sex and cancer location (rectum, left and right colon). Responses were received from 97/267 (35%) patients with a wide age range (29-87), equal sex ratio and cancer location. Attendees of the international Tripartite Colorectal Conference were eligible for the consensus meeting. OUTCOMES: Phase 1: Information of potential importance to patients was extracted verbatim and operationalised into a Delphi questionnaire. Phase 2: Patients and professionals rated the importance information on a 9-point Likert scale, and resurveyed following group feedback. Information rated of low importance were discarded using predefined criteria. Phase 3: A modified nominal group technique was used to gain final consensus in separate consensus meetings with patients and professionals. RESULTS: Data sources identified 1216 pieces of information that informed a 98-item questionnaire. Analysis led to 50 and 23 information domains being retained after the first and second surveys, respectively. The final CIS included 11 concepts including specific surgical complications, short and long-term survival, disease recurrence, stoma and quality of life issues. CONCLUSIONS: This study has established a CIS for professionals to discuss with patients before CRC surgery.

Three wound-dressing strategies to reduce surgical site infection after abdominal surgery: the Bluebelle feasibility study and pilot RCT.

BACKGROUND: Surgical site infection (SSI) affects up to 20% of people with a primary closed wound after surgery. Wound dressings may reduce SSI. OBJECTIVE: To assess the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of dressing types or no dressing to reduce SSI in primary surgical wounds. DESIGN: Phase A - semistructured interviews, outcome measure development, practice survey, literature reviews and value-of-information analysis. Phase B - pilot RCT with qualitative research and questionnaire validation. Patients and the public were involved. SETTING: Usual NHS care. PARTICIPANTS: Patients undergoing elective/non-elective abdominal surgery, including caesarean section. INTERVENTIONS: Phase A - none. Phase B - simple dressing, glue-as-a-dressing (tissue adhesive) or 'no dressing'. MAIN OUTCOME MEASURES: Phase A - pilot RCT design; SSI, patient experience and wound management questionnaires; dressing practices; and value-of-information of a RCT. Phase B - participants screened, proportions consented/randomised; acceptability of interventions; adherence; retention; validity and reliability of SSI measure; and cost drivers. DATA SOURCES: Phase A - interviews with patients and health-care professionals (HCPs), narrative data from published RCTs and data about dressing practices. Phase B - participants and HCPs in five hospitals. RESULTS: Phase A - we interviewed 102 participants. HCPs interpreted 'dressing' variably and reported using available products. HCPs suggested practical/clinical reasons for dressing use, acknowledged the weak evidence base and felt that a RCT including a 'no dressing' group was acceptable. A survey showed that 68% of 1769 wounds (727 participants) had simple dressings and 27% had glue-as-a-dressing. Dressings were used similarly in elective and non-elective surgery. The SSI questionnaire was developed from a content analysis of existing SSI tools and interviews, yielding 19 domains and 16 items. A main RCT would be valuable to the NHS at a willingness to pay of £20,000 per quality-adjusted life-year. Phase B - from 4 March 2016 to 30 November 2016, we approached 862 patients for the pilot RCT; 81.1% were eligible, 59.4% consented and 394 were randomised (simple, n = 133; glue, n = 129; no dressing, n = 132); non-adherence was 3 out of 133, 8 out of 129 and 20 out of 132, respectively. SSI occurred in 51 out of 281 participants. We interviewed 55 participants. All dressing strategies were acceptable to stakeholders, with no indication that adherence was problematic. Adherence aids and patients' understanding of their allocated dressing appeared to be key. The SSI questionnaire response rate overall was 67.2%. Items in the SSI questionnaire fitted a single scale, which had good reliability (test-retest and Cronbach's alpha of > 0.7) and diagnostic accuracy (c-statistic = 0.906). The key cost drivers were hospital appointments, dressings and redressings, use of new medicines and primary care appointments. LIMITATIONS: Multiple activities, often in parallel, were challenging to co-ordinate. An amendment took 4 months, restricting recruitment to the pilot RCT. Only 67% of participants completed the SSI questionnaire. We could not implement photography in theatres. CONCLUSIONS: A main RCT of dressing strategies is feasible and would be valuable to the NHS. The SSI questionnaire is sufficiently accurate to be used as the primary outcome. A main trial with three groups (as in the pilot) would be valuable to the NHS, using a primary outcome of SSI at discharge and patient-reported SSI symptoms at 4-8 weeks. TRIAL REGISTRATION: Phase A - Current Controlled Trials ISRCTN06792113; Phase B - Current Controlled Trials ISRCTN49328913. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 39. See the NIHR Journals Library website for further project information. Funding was also provided by the Medical Research Council ConDuCT-II Hub (reference number MR/K025643/1).

Wound infections are common after surgery. Some are cured with simple treatment, but others may lead to serious problems. Reducing the risk of a wound infection is important. We do not know if the type of dressing, or not using a dressing, influences the risk of infection. A study that allocated patients to receive different dressings (or no dressing) would answer this question. We did preliminary research to explore whether or not such a study is possible. We interviewed doctors, nurses and patients about their views on dressings and a future study. We also described dressings currently being used in the NHS and found that simple dressings and tissue adhesive (glue) 'as-a-dressing' are used most frequently. We studied existing evidence and interviewed experts to develop a questionnaire, completed by patients, to identify wound infections after patients leave hospital and tested its accuracy. We also explored taking photographs of wounds. We investigated whether or not a major study would be worth the cost and designed a pilot study to test its feasibility. The pilot study recruited 394 patients undergoing abdominal operations in five NHS hospitals. These patients were allocated to have a simple dressing, glue-as-a-dressing or no dressing, and 92% received the allocated dressing method. Patients and their doctors and nurses found the dressing methods to be acceptable. We showed that the new patient questionnaire accurately identified infections. Patients or their carers also found it acceptable to photograph their wounds. Our research suggests that a future large study would be worth the investment and is possible.

Evaluation of the Collaborative Use of an Evidence-Based Care Bundle in Emergency Laparotomy.

Importance: Patients undergoing emergency laparotomy have high mortality, but few studies exist to improve outcomes for these patients. Objective: To assess whether a collaborative approach to implement a 6-point care bundle is associated with reduction in mortality and length of stay and improvement in the delivery of standards of care across a group of hospitals. Design, Setting, and Participants: The Emergency Laparotomy Collaborative (ELC) was a UK-based prospective quality improvement study of the implementation of a care bundle provided to patients requiring emergency laparotomy between October 1, 2015, and September 30, 2017. Participants were 28 National Health Service hospitals and emergency surgical patients who were treated at these hospitals and whose data were entered into the National Emergency Laparotomy Audit (NELA) database. Post-ELC implementation outcomes were compared with baseline data from July 1, 2014, to September 30, 2015. Data entry and collection were performed through the NELA. Interventions: A 6-point, evidence-based care bundle was used. The bundle included prompt measurement of blood lactate levels, early review and treatment for sepsis, transfer to the operating room within defined time goals after the decision to operate, use of goal-directed fluid therapy, postoperative admission to an intensive care unit, and multidisciplinary involvement of senior clinicians in the decision and delivery of perioperative care. Change management and leadership coaching were provided to ELC leadership teams. Main Outcome and Measures: Primary outcomes were in-hospital mortality, both crude and Portsmouth Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (P-POSSUM) risk-adjusted, and length of stay. Secondary outcomes were the changes after implementation of the separate metrics in the care bundle. Results: A total of 28 hospitals participated in the ELC and completed the project. The baseline group included 5562 patients (2937 female [52.8%] and a mean [range] age of 65.3 [18.0-114.0] years), whereas the post-ELC group had 9247 patients (4911 female [53.1%] and a mean [range] age of 65.0 [18.0-99.0] years). Unadjusted mortality rate decreased from 9.8% at baseline to 8.3% in year 2 of the project, and so did risk-adjusted mortality from a baseline of 5.3% to 4.5% post-ELC. Mean length of stay decreased from 20.1 days during year 1 to 18.9 days during year 2. Significant changes in 5 of the 6 metrics in the care bundle were achieved. Conclusions and Relevance: A collaborative approach using a quality improvement methodology and a care bundle appeared to be effective in reducing mortality and length of stay in emergency laparotomy, suggesting that hospitals should adopt such an approach to see better patient outcomes and care delivery performance.

Distributions of the National Early Warning Score (NEWS) across a healthcare system following a large-scale roll-out.

BACKGROUND: Early warning scores (EWS) were developed in acute hospital settings to improve recognition and response to patient deterioration. In 2012, the UK Royal College of Physicians developed the National Early Warning Score (NEWS) to standardise EWS across the NHS. Its use was also recommended outside acute hospital settings; however, there is limited information about NEWS in these settings. From March 2015, NEWS was implemented across the healthcare system in the West of England, with the aim that NEWS would be calculated for all patients prior to referral into acute care. AIM: To describe the distribution and use of NEWS in out-of-hospital settings for patients with acute illness or long-term conditions, following system wide implementation. METHOD: Anonymised data were obtained from 115 030 emergency department (ED) attendances, 1 137 734 ambulance electronic records, 31 063 community attendances and 15 160 general practitioner (GP) referrals into secondary care, in the West of England. Descriptive statistics are presented. RESULTS: Most attendance records had NEWS=0-2: 80% in ED, 67% of ambulance attendances and 72% in the community. In contrast, only 8%, 18% and 11% of attendances had NEWS ≥5 (the trigger for escalation of care in-hospital), respectively. Referrals by a GP had higher NEWS on average (46% NEWS=0-2 and 30% NEWS ≥5). By April 2016, the use of NEWS was reasonably stable in ED, ambulance and community populations, and still increasing for GP referrals. CONCLUSIONS: NEWS ≥5 occurred in less than 20% of ED, ambulance and community populations studied and 30% of GP referrals. This suggests that in most out-of-hospital settings studied, high scores are reasonably uncommon.

Using the National Early Warning Score (NEWS) outside acute hospital settings: a qualitative study of staff experiences in the West of England.

OBJECTIVES: Early warning scores were developed to improve recognition of clinical deterioration in acute hospital settings. In England, the National Early Warning Score (NEWS) is increasingly being recommended at a national level for use outside such settings. In 2015, the West of England Academic Health Science Network supported the roll-out of NEWS across a range of non-acute-hospital healthcare sectors. Research on the use of NEWS outside acute hospitals is limited. The objective of this study was to explore staff experiences of using NEWS in these new settings. DESIGN: Thematic analysis of qualitative semi-structured interviews with purposefully sampled healthcare staff. SETTING: West of England healthcare settings where NEWS was being used outside acute hospitals-primary care, ambulance, referral management, community and mental health services. PARTICIPANTS: Twenty-five healthcare staff interviewed from primary care (9), ambulance (3), referral management/acute interface (5), community (4) and mental health services (3), and service commissioning (1). RESULTS: Participants reported that NEWS could support clinical decision-making around escalation of care, and provide a clear means of communicating clinical acuity between clinicians and across different healthcare organisations. Challenges with implementing NEWS varied-in primary care, clinicians had to select patients for NEWS and adopt different methods of clinical assessment, whereas for paramedics it fitted well with usual clinical practice and was used for all patients. In community services and mental health, modifications were 'needed' to make the tool relevant to some patient populations. CONCLUSIONS: This study demonstrated that while NEWS can work for staff outside acute hospital settings, the potential for routine clinical practice to accommodate NEWS in such settings varied. A tailored approach to implementation in different settings, incorporating guidance supported by further research on the use of NEWS with specific patient groups in community settings, may be beneficial, and enhance staff confidence in the tool.

Can early warning scores identify deteriorating patients in pre-hospital settings? A systematic review.

OBJECTIVE: To evaluate the effectiveness and predictive accuracy of early warning scores (EWS) to predict deteriorating patients in pre-hospital settings. METHODS: Systematic review. Seven databases searched to August 2017. Study quality was assessed using QUADAS-2. A narrative synthesis is presented. ELIGIBILITY: Studies that evaluated EWS predictive accuracy or that compared outcomes in populations that did or did not use EWS, in any pre-hospital setting were eligible for inclusion. EWS were included if they aggregated three or more physiological parameters. RESULTS: Seventeen studies (157,878 participants) of predictive accuracy were included (16 in ambulance service and 1 in nursing home). AUCs ranged from 0.50 (CI not reported) to 0.89 (95%CI 0.82, 0.96). AUCs were generally higher (>0.80) for prediction of mortality within short time frames or for combination outcomes that included mortality and ICU admission. Few patients with low scores died at any time point. Patients with high scores were at risk of deterioration. Results were less clear for intermediate thresholds (≥4 or 5). Five studies were judged at low or unclear risk of bias, all others were judged at high risk of bias. CONCLUSIONS: Very low and high EWS are able to discriminate between patients who are not likely and those who are likely to deteriorate in the pre-hospital setting. No study compared outcomes pre- and post-implementation of EWS so there is no evidence on whether patient outcomes differ between pre-hospital settings that do and do not use EWS. Further studies are required to address this question and to evaluate EWS in pre-hospital settings.

Core Outcomes for Colorectal Cancer Surgery: A Consensus Study.

BACKGROUND: Colorectal cancer (CRC) is a major cause of worldwide morbidity and mortality. Surgical treatment is common, and there is a great need to improve the delivery of such care. The gold standard for evaluating surgery is within well-designed randomized controlled trials (RCTs); however, the impact of RCTs is diminished by a lack of coordinated outcome measurement and reporting. A solution to these issues is to develop an agreed standard "core" set of outcomes to be measured in all trials to facilitate cross-study comparisons, meta-analysis, and minimize outcome reporting bias. This study defines a core outcome set for CRC surgery. METHODS AND FINDINGS: The scope of this COS includes clinical effectiveness trials of surgical interventions for colorectal cancer. Excluded were nonsurgical oncological interventions. Potential outcomes of importance to patients and professionals were identified through systematic literature reviews and patient interviews. All outcomes were transcribed verbatim and categorized into domains by two independent researchers. This informed a questionnaire survey that asked stakeholders (patients and professionals) from United Kingdom CRC centers to rate the importance of each domain. Respondents were resurveyed following group feedback (Delphi methods). Outcomes rated as less important were discarded after each survey round according to predefined criteria, and remaining outcomes were considered at three consensus meetings; two involving international professionals and a separate one with patients. A modified nominal group technique was used to gain the final consensus. Data sources identified 1,216 outcomes of CRC surgery that informed a 91 domain questionnaire. First round questionnaires were returned from 63 out of 81 (78%) centers, including 90 professionals, and 97 out of 267 (35%) patients. Second round response rates were high for all stakeholders (>80%). Analysis of responses lead to 45 and 23 outcome domains being retained after the first and second surveys, respectively. Consensus meetings generated agreement on a 12 domain COS. This constituted five perioperative outcome domains (including anastomotic leak), four quality of life outcome domains (including fecal urgency and incontinence), and three oncological outcome domains (including long-term survival). CONCLUSION: This study used robust consensus methodology to develop a core outcome set for use in colorectal cancer surgical trials. It is now necessary to validate the use of this set in research practice.