Which outcomes are most important to measure in patients with COVID-19 and how and when should these be measured? Development of an international standard set of outcomes measures for clinical use in patients with COVID-19: a report of the International Consortium for Health Outcomes Measurement (ICHOM) COVID-19 Working Group.

OBJECTIVES: The COVID-19 pandemic has resulted in widespread morbidity and mortality with the consequences expected to be felt for many years. Significant variation exists in the care even of similar patients with COVID-19, including treatment practices within and between institutions. Outcome measures vary among clinical trials on the same therapies. Understanding which therapies are of most value is not possible unless consensus can be reached on which outcomes are most important to measure. Furthermore, consensus on the most important outcomes may enable patients to monitor and track their care, and may help providers to improve the care they offer through quality improvement. To develop a standardised minimum set of outcomes for clinical care, the International Consortium for Health Outcomes Measurement (ICHOM) assembled a working group (WG) of 28 volunteers, including health professionals, patients and patient representatives. DESIGN: A list of outcomes important to patients and professionals was generated from a systematic review of the published literature using the MEDLINE database, from review of outcomes being measured in ongoing clinical trials, from a survey distributed to patients and patient networks, and from previously published ICHOM standard sets in other disease areas. Using an online-modified Delphi process, the WG selected outcomes of greatest importance. RESULTS: The outcomes considered by the WG to be most important were selected and categorised into five domains: (1) functional status and quality of life, (2) mental functioning, (3) social functioning, (4) clinical outcomes and (5) symptoms. The WG identified demographic and clinical variables for use as case-mix risk adjusters. These included baseline demographics, clinical factors and treatment-related factors. CONCLUSION: Implementation of these consensus recommendations could help institutions to monitor, compare and improve the quality and delivery of care to patients with COVID-19. Their consistent definition and collection could also broaden the implementation of more patient-centric clinical outcomes research.

Development of an international standard set of outcome measures for patients with atrial fibrillation: a report of the International Consortium for Health Outcomes Measurement (ICHOM) atrial fibrillation working group.

AIMS: As health systems around the world increasingly look to measure and improve the value of care that they provide to patients, being able to measure the outcomes that matter most to patients is vital. To support the shift towards value-based health care in atrial fibrillation (AF), the International Consortium for Health Outcomes Measurement (ICHOM) assembled an international Working Group (WG) of 30 volunteers, including health professionals and patient representatives to develop a standardized minimum set of outcomes for benchmarking care delivery in clinical settings. METHODS AND RESULTS: Using an online-modified Delphi process, outcomes important to patients and health professionals were selected and categorized into (i) long-term consequences of disease outcomes, (ii) complications of treatment outcomes, and (iii) patient-reported outcomes. The WG identified demographic and clinical variables for use as case-mix risk adjusters. These included baseline demographics, comorbidities, cognitive function, date of diagnosis, disease duration, medications prescribed and AF procedures, as well as smoking, body mass index (BMI), alcohol intake, and physical activity. Where appropriate, and for ease of implementation, standardization of outcomes and case-mix variables was achieved using ICD codes. The standard set underwent an open review process in which over 80% of patients surveyed agreed with the outcomes captured by the standard set. CONCLUSION: Implementation of these consensus recommendations could help institutions to monitor, compare and improve the quality and delivery of chronic AF care. Their consistent definition and collection, using ICD codes where applicable, could also broaden the implementation of more patient-centric clinical outcomes research in AF.

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.

Unlocking the potential of value-based health care by defining global standard sets of outcome measures that matter to patients with cardiovascular diseases.

As health systems around the world increasingly look to record and improve the value of care that they provide to patients, being able to measure the outcomes that matter most to patients is vital. Clinicians today gather more data than ever before, but what is measured often has little relationship to the results of care that matter most to patients. Through its working groups of global experts in particular diseases, the International Consortium for Health Outcomes Measurement aims to define minimum Standard Sets of outcomes, along with case-mix factors to support risk adjustment and meaningful comparison. These Standard Sets may then be implemented globally empowering patients to select providers with the best outcomes at the lowest cost, empowering providers that deliver superior outcomes at competitive costs to excel, and empowering payers to negotiate contracts based on results. The International Consortium for Health Outcomes Measurement has published 24 Standard Sets including coronary artery disease, heart failure, hypertension, and stroke and is nearing the completion of its work in atrial fibrillation.

Does the implementation of a novel intensive care discharge risk score and nurse-led inpatient review tool improve outcome? A prospective cohort study in two intensive care units in the UK.

OBJECTIVE: To develop a clinical prediction model for poor outcome after intensive care unit (ICU) discharge in a large observational data set and couple this to an acute post-ICU ward-based review tool (PIRT) to identify high-risk patients at the time of ICU discharge and improve their acute ward-based review and outcome. DESIGN: Retrospective patient cohort of index ICU admissions between June 2006 and October 2011 receiving routine inpatient review. Prospective cohort between March 2012 and March 2013 underwent risk scoring (PIRT) which subsequently guided inpatient ward-based review. SETTING: Two UK adult ICUs. PARTICIPANTS: 4212 eligible discharges from ICU in the retrospective development cohort and 1028 patients included in the prospective intervention cohort. INTERVENTIONS: Multivariate analysis was performed to determine factors associated with poor outcome in the retrospective cohort and used to generate a discharge risk score. A discharge and daily ward-based review tool incorporating an adjusted risk score was introduced. The prospective cohort underwent risk scoring at ICU discharge and inpatient review using the PIRT. OUTCOMES: The primary outcome was the composite of death or readmission to ICU within 14 days of ICU discharge following the index ICU admission. RESULTS: PIRT review was achieved for 67.3% of all eligible discharges and improved the targeting of acute post-ICU review to high-risk patients. The presence of ward-based PIRT review in the prospective cohort did not correlate with a reduction in poor outcome overall (P=0.876) or overall readmission but did reduce early readmission (within the first 48 hours) from 4.5% to 3.6% (P=0.039), while increasing the rate of late readmission (48 hours to 14 days) from 2.7% to 5.8% (P=0.046). CONCLUSION: PIRT facilitates the appropriate targeting of nurse-led inpatient review acutely after ICU discharge but does not reduce hospital mortality or overall readmission rates to ICU.

Establishing a legal service for major trauma patients at a major trauma centre in the UK.

BACKGROUND: Major trauma causes unanticipated critical illness and patients have often made few arrangements for what are sudden and life-changing circumstances. This can lead to financial, housing, insurance, legal and employment issues for patients and their families.A UK law firm worked with the major trauma services to develop a free and comprehensive legal service for major trauma patients and their families at a major trauma centre (MTC) in the UK. METHODS: In 2013, a legal service was established at North Bristol NHS Trust. Referrals are made by trauma nurse practitioners and it operates within a strict ethical framework. A retrospective analysis of the activity of this legal service between September 2013 and October 2015 was undertaken. RESULTS: 66 major trauma patients were seen by the legal teams at the MTC. 535 hours of free legal advice were provided on non-compensation issues-an average of 8 hours per patient. DISCUSSION: This initiative confirms a demand for the early availability of legal advice for major trauma patients to address a range of non-compensation issues as well as for identification of potential compensation claims. The availability of advice at the MTC is convenient for relatives who may be spending the majority of their time with injured relatives in hospital. More data are needed to establish the rehabilitation and health effects of receiving non-compensation advice after major injury; however, the utilisation of this service suggests that it should be considered at the UK MTCs.

Prevention of acute kidney injury through accurate fluid balance monitoring.

Acute kidney injury (AKI) is associated with increased patient morbidity, mortality and an extended hospital stay. The financial burden to the National Health Service is high and it can affect up to one in five inpatients. Optimal fluid balance management is essential for the prevention of AKI and this can be particularly challenging in the patient with trauma. Our aim was to reduce the rate of AKI in patients with traumatic injuries in the regional trauma centre. We developed new fluid balance charts and documented how well these were completed. The number of AKI alerts per month was calculated on our pathology system. Scenario training was delivered at handover meetings and an e-learning tool was designed at three levels: healthcare assistants; nurses; and medical staff, dietetics and pharmacists. Educational posters were placed in clinical areas and patient information leaflets produced. Junior doctors were regularly informed of AKI rates on the ward. The number of AKI alerts on our trauma ward declined from 50 in January 2016 to 19 in November 2016. The mean monthly rate of AKI fell 33% following the invention (P<0.001). Completion of fluid balance charts improved; 6 hourly urine output documentation increased from 36% to 68% and running 1 hourly output increased from 80% to 96%. Calculation of total daily fluid balance rose from 12% to 72%, before decreasing to 32%. This highlighted the need for continued encouragement. Improved fluid balance monitoring led to a reduction in the prevalence of AKI in patients admitted to this trauma centre.

A Case of Stercoral Perforation Detected on CT Requiring Proctocolectomy in a Heroin-Dependent Patient.

Stercoral perforation of the colon is rare but carries with it significant morbidity and mortality. Stercoral perforation usually occurs in elderly, immobile patients with chronic constipation. In this manuscript, we report the case of stercoral perforation in a patient due to chronic heroin dependence. We report the case of a 56-year-old male patient with stercoral perforation, diagnosed by computed tomography, secondary to heroin dependence, requiring proctocolectomy and an end ileostomy. There are very few reports in the literature describing cases of stercoral perforation and questions have been asked about the importance of preoperative cross-sectional imaging. In our case, the diagnosis of stercoral perforation was made only on CT. Although this is not the first such case to be reported, it is significant as preoperative CT imaging was influential not only in determining the aetiology of the abdominal distension seen on the plain film, but also in detecting the pneumoperitoneum which was not evident clinically or on plain radiographs.

Initial experience in setting up a medical student first responder scheme in South Central England.

Prehospital emergency medicine (PHEM) is a recently recognised subspecialty of emergency medicine, and anaesthetics, intensive care and acute medicine, in the UK, and yet it receives little to no mention in many undergraduate medical curricula. However, there is growing interest in PHEM among medical students and junior doctors. Several programmes are in existence across the UK that serve to provide teaching and exposure of prehospital care to medical students and junior doctors. However, relatively few students are able to gain significant first-hand experience of treating patients in the prehospital phase. In this short report, we discuss our experience of launching the student first responder (SFR) scheme across three counties in the Thames Valley. Medical students are trained by the regional ambulance service and respond to life-threatening medical emergencies in an ambulance response vehicle. The scheme is likely to benefit the ambulance service by providing a wider pool of trained volunteer first responders able to attend to emergency calls, to benefit patients by providing a quick response at their time of need, and to benefit medical students by providing first-hand experience of medical emergencies in the community. In its first 15 months of operation, SFRs were dispatched to 343 incidents. This scheme can serve as a training model for other ambulance services and medical schools across the UK.

"SHOUT" to improve the quality of care delivered to patients with acute kidney injury at Great Western Hospital.

Acute kidney injury (AKI) affects up to 20% of all patients admitted to hospital, and is associated with a higher risk of adverse clinical outcomes, increased healthcare costs, as well as long term risks of chronic kidney disease and end stage renal failure. The aim of this project was to improve the quality of care for patients with AKI admitted to the acute medical unit (AMU) at the Great Western Hospital (GWH). We assessed awareness and self reported confidence among physicians in our Trust, in addition to basic aspects of care relevant to AKI on our AMU. A multifaceted quality improvement strategy was developed, which included measures to improve awareness such as a Trust wide AKI awareness day, and reconfiguring the admission proforma on our AMU in order to enhance risk assessment, staging, and early response to AKI. Ancillary measures such as the dissemination of flashcards for lanyards containing core information were also used. Follow up assessments showed that foundation year one (FY1) doctors' self reported confidence in managing AKI increased from 2.8 to 4.2, as measured on a five point Likert scale (P=0.0003). AKI risk assessment increased from 13% to 57% (P=0.07) following a change in the admission proforma. Documentation of the diagnosis of AKI increased from 66% to 95% (P=0.038) among flagged patients. Documentation of urine dip results increased from 33% to 73% (P=0.01), in addition to a rise in appropriate referral for specialist input, although this was not statistically significant. Our results suggest that using the twin approaches of improving awareness, and small changes to systemic factors such as modification of the admission proforma, can lead to significant enhancements in the quality of care of patients with AKI.

The status quo has got to go.

The healthcare profession has a reputation as a very conservative occupation. As a result, innovation in medicine comes about very slowly. There are numerous examples from medical history where innovators were sanctioned and even ostracized for their new ideas and recommendations to make medical care for patients better. This also applies to the business of medicine. This article will discuss examples from history where doctors have attempted to advance the clinical aspects of medicine, receiving condemnation from their peers and colleagues, and ultimately receiving approval and even the Nobel Prize on several occasions. It will also review innovation and its implications for nonclinical aspects of medical care.

Abnormal gastric myoelectrical activity in postural tachycardia syndrome.

OBJECTIVE: Postural tachycardia syndrome (PoTS) is an important cause of orthostatic intolerance resulting from cardiovascular autonomic dysfunction. In addition to postural symptoms, PoTS patients may have allied features, including gastrointestinal (GI) symptoms, which have not yet been thoroughly investigated. We evaluated gastric myoelectrical activity in PoTS patients. METHODS: Using cutaneous electrogastrography (EGG), we recorded gastric myoelectrical activity before and after standard liquid meal ingestion in 15 PoTS patients (age 27 ± 4 years); including 7 with and 8 without GI symptoms, and in 11 healthy individuals (age 23 ± 7 years). We performed spectral analysis of EGG recordings to obtain the dominant frequency of gastric pacemaker rhythm (DF), instability coefficient of DF (ICDF), and low (LFR%), normal (NFR%), and high (HFR%) range power percentages of the total power. RESULTS: Instability coefficient of DF, an index of variability of gastric pacemaker rhythm, was significantly elevated both pre- and post-prandially (30-45 min after the meal) in the PoTS group (8.8 ± 6, 10.0 ± 8 %) compared with controls (4.0 ± 3, 4.0 ± 3 %; both p < 0.05). Patients with GI symptoms had significantly higher post-prandial ICDF (15.0 ± 5 %) than those without GI symptoms (5.6 ± 4 %; p < 0.05). There were no significant differences in DF, LFR%, NFR% and HFR% before and after the meal between the PoTS and control groups, or between PoTS patients with and without GI symptoms. INTERPRETATION: Our study revealed increased variability of gastric pacemaker rhythm in PoTS, and these findings might be related to pathophysiology of functional GI symptoms in PoTS.