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ObjectiveThe aim of this study is to examine the pathways by which work–life balance influences safety climate in hospital settings.DesignA national cross-sectional survey on patient safety culture.SettingsHealthcare workers from 56 hospitals in Taiwan, covering three work settings: intensive care units, operation rooms and emergency departments.Participants14 345 healthcare workers took part in the survey and were included in the present analysis.Primary and secondary outcome measuresThe Safety Attitudes, Maslach’s Burn-out Inventory and Work–life balance questionnaires were used to measure patient safety culture, teamwork, leadership, emotional exhaustion and work–life balance. Path analysis was conducted to determine the relationship between work–life balance and safety climate. We tested for mediating and moderating factors influencing this relationship.ResultsThe path between work–life balance and safety climate was found to be significant (b=0.32, pConclusionWe found work–life balance to be associated with safety climate through a fully mediated model. The mediation pathways are moderated by self-identified leadership and perceptions of leadership. Understanding the pathways on how work–life balance influences safety climate provides an explanatory model that can be used when designing effective interventions for implementation in system-based approaches to improve patient safety culture in hospital settings.

Introduction The burden of atrial fibrillation (AF) in Thailand is high and associated with increased morbidity, mortality and healthcare costs. Vitamin K antagonists (eg, warfarin), commonly used for stroke prevention in patients with AF in Thailand, are effective but are often suboptimally controlled. We aim to evaluate the impact of an SAMe-TT2R2 score-guided strategy and educational intervention compared to usual care on anticoagulation control expressed by the time in therapeutic range (TTR) at 12 months, in anticoagulant-naïve Thai patients with AF. Methods and analysis Multicentre, open-label, parallel-group, randomised controlled trial conducted in Thailand among adult patients (age: 18 years) with AF who are anticoagulant naïve. Patients will be randomised to one of two groups; an SAMe-TT2R2 score-guided strategy with educational intervention and usual care versus usual care alone. The planned follow-up period is 12 months. The primary outcome is TTR at 12 months. Secondary outcomes include: (1) TTR at 6 months; (2) thromboembolic and bleeding events at 12 months; (3) composite major adverse cardiovascular events at 12 months; (4) change in patients’ knowledge of AF between baseline and 6 months and 12 months; (5) cost effectiveness; (6) quality of life at baseline, 6 months and 12 months using EQ-5D-5L (Thai version) and (7) patient satisfaction/perceptions of the TREAT intervention. An embedded qualitative study will assess patient perceptions of the TREAT intervention. Ethics and dissemination The study has been approved by the Ethical Review Committee, Ministry of Public Health of Thailand, and registered in the Thai Clinical Trials Registry. The results of this trial will be submitted for publication in a peer-reviewed journal. Participants will be informed via a link to a preview of the publication. A lay summary will also be provided to all participants prior to publication. Trial registration number TCTR20180711003.

ObjectiveTransient ischaemic attacks (TIA) and minor strokes are important risk factors for further vascular events. We explored the role of albumin creatinine ratio (ACR) in improving risk prediction after a first event.SettingRapid access stroke clinics in the UK.Participants2202 patients attending with TIA or minor stroke diagnosed by the attending stroke physician, able to provide a urine sample to evaluate ACR using a near-patient testing device.Primary and secondary outcomesPrimary outcome was major adverse cardiac events (MACE: recurrent stroke, myocardial infarction or cardiovascular death) at 90 days. The key secondary outcome was to determine whether urinary ACR could contribute to a risk prediction tool for use in a clinic setting.Results151 MACE occurred in 144 participants within 90 days. Participants with MACE had higher ACR than those without. A composite score awarding a point each for age >80 years, previous stroke/TIA and presence of microalbuminuria identified those at low risk and high risk. 90% of patients were at low risk (scoring 0 or 1). Their 90-day risk of MACE was 5.7%. Of the remaining ‘high-risk’ population (scoring 2 or 3) 12.4% experienced MACE over 90 days (pConclusionA risk score comprising age, previous stroke/TIA and microalbuminuria predicts future MACE while identifying those at low risk of a recurrent event. This tool shows promise in the risk stratification of patients to avoid the admission of low-risk patients.

ObjectivesThe use of aspirin to prevent cardiovascular disease in vasospastic angina (VSA) patients without significant stenosis has yet to be investigated. This study aimed to investigate the efficacy of aspirin use among VSA patients.DesignSystematic review and meta-analysis.Data sourcesPubMed, Web of Science and Cochrane Central Register of Controlled Trials were searched for relevant information prior to October 2020.Eligibility criteria for selecting studiesAspirin use versus no aspirin use (placebo or no treatment) among VSA patients without significant stenosis.Data extraction and synthesisTwo investigators extracted the study data. ORs and 95% CIs were calculated and graphed as forest plots. The Newcastle-Ottawa Quality Assessment Scale tool and Begg’s funnel plot were used to assess risk of bias.ResultsFour propensity-matched cohorts, one retrospective analysis and one prospective multicentre cohort, in total comprising 3661 patients (aspirin use group, n=1695; no aspirin use group, n=1966) were included in this meta-analysis. Aspirin use and the incidence of major cardiovascular adverse events with follow-up of 1–5 years were not significantly correlated (combined OR=0.90, 95% CI: 0.55 to 1.68, p=0.829, I2=82.2%; subgroup analysis: OR=1.09, 95% CI: 0.81 to 1.47, I2=0%). No significant difference was found between aspirin use and the incidence of myocardial infarction (OR=0.62, 95% CI: 0.09 to 4.36, p=0.615, I2=73.8%) or cardiac death (OR=1.73, 95% CI: 0.61 to 4.94, p=0.444, I2=0%) during follow-up.ConclusionAspirin use may not reduce the risk of future cardiovascular events in VSA patients without significant stenosis.PROSPERO registration numberCRD42020214891.

ObjectiveRapid, accurate identification of patients with acute myocardial infarction (AMI) at high risk of in-hospital major adverse cardiac events (MACE) is critical for risk stratification and prompt management. This study aimed to develop a simple, accessible tool for predicting in-hospital MACE in Chinese patients with AMI.DesignRetrospective review of deidentified medical records.Setting38 urban and rural hospitals across diverse economic and geographic areas in China (Beijing, Henan Province and Jilin Province).Participants15 009 patients discharged from hospital with a diagnosis of AMI.Main outcome measureThe primary outcome was MACE occurrence during index hospitalisation. A multivariate logistic regression model (China AMI Risk Model, CHARM) derived using patient data from Beijing (n=7329) and validated with data from Henan (n=4247) and Jilin (n=3433) was constructed to predict the primary outcome using variables of age, white cell count (WCC) and Killip class. C-statistics evaluated discrimination in the derivation and validation cohorts, with goodness-of-fit assessed using Hosmer-Lemeshow statistics.ResultsThe CHARM model included age (OR: 1.06 per 1-year increment, 95% CI 1.05 to 1.07, p9/L increment: 1.10 (95% CI 1.07 to 1.13), pConclusionsThe CHARM model provides an inexpensive, accurate and readily accessible tool for predicting in-hospital MACE in Chinese patients with AMI.

ObjectiveIn 2014, an escalation plan and morning handover meetings were implemented in an intensive care unit (ICU) to reduce access block for post-operative care. In this study, the improvement intervention is revisited 5 years on with the objective to see if the changes are sustained and to understand factors contributing to sustainability.DesignA mixed-method approach was used, with quantitative analysis of ICU administrative data and qualitative analysis of interviews with hospital management and ICU staff.SettingICU with mixed surgical and non-surgical cases in a regional hospital in Australia.ParticipantsInterview participants: ICU nurses (four), ICU doctors (four) and hospital management (four).Main outcome measuresMonthly number of elective surgeries were cancelled due to unavailability of ICU beds. Staff perceptions of the interventions and factors contributed to sustainability.ResultsAfter a decline in elective surgeries being cancelled in the first year after the intervention, there was an increase in cancellations in the following years (χ2=16.38, p=0.003). Lack of knowledge about the intervention and competitive interests in the management of patient flow were believed to be obstacles for sustained effects of the original intervention. So were communication deficiencies that were reported within the ICU and between ICU and other departments. There are discrepancies between how nurses and doctors use the escalation plan and regard the availability of ICU beds.ConclusionImprovement interventions in healthcare that appear initially to be successful are not necessarily sustained over time, as was the case in this study. In healthcare, there is no such thing as a ‘fix and forget’ solution for interventions. Management commitment to support communication within and between microsystems, and to support healthcare staff understanding of the underlying reasons for intervention, are important implications for change and change management across healthcare systems.

Objectives Acute care units manage high risk patients at the edge of scientifically established treatments and organisational constraints while aiming to balance reliability to standards with the needs of situational adaptation (resilience). First-line managers are central in coordinating clinical care. Any systemic brittleness will be evident only in retrospect through, for example, care quality measures and accident statistics. This challenges us to understand what successful managerial strategies for adaptation are and how they could be improved. The managerial work of balancing reliability and adaptation is only partially understood. This study aims to explore and describe how system resilience is enhanced by naturally occurring coordination performed in situ by a management team under variable circumstances. Design An explorative observational study of a tertiary neonatal intensive care unit (NICU) in Sweden. One year of broad preparatory work followed by focused shadowing observations of coordination analysed through inductive–deductive content analysis from a perspective of resilience engineering. Participants A team of managers (ie, clinical coordinators, head nurses, senior medical doctors). Results The results describe a functional relationship between operational stress and a progression of adjustments in the actual situation, expressed through recurring patterns of adaptation. Managers focused on maintaining coherence in escalating problematic situations by facilitating teamwork through goalsetting, problem-solving and circumventing the technical systems’ limitations. Conclusions Coordination supports a coherent goal setting by increased team collaboration and is supported by team members’ abilities to predict the behaviour of each other. Our findings suggest that in design of future research or training for coordination, the focus of assessment and reflection on adaptive managerial responses may lie on situations where the system was ‘stretched’ or ‘needed reorganisation’ and that learning should be about whether the actions were able to achieve short-term goals while preserving the long-term goals.

ObjectivesTo assess the knowledge, attitude and practice (KAP) concerning healthcare-associated infections (HAIs) among healthcare givers and to identify the factors influencing KAP.DesignThis was a hospital-based, cross-sectional study.SettingTwo public hospitals in Wuhan, central China.ParticipantsParticipants were recruited among healthcare workers (HCWs) of one general hospital and one children’s hospital in Wuhan city between 1 June and 30 September 2019.Primary and secondary outcome measuresThe outcomes were KAPs concerning HAIs.ResultsData from 455 HCWs were included in the final data analysis. The mean scores of KAP and total KAP were 15.67±3.32, 25.00±2.75, 43.44±5.15 and 84.76±6.72, respectively. The following factors were significantly associated with the total KAP score concerning HAIs, explaining 61% of the variance (pConclusionThe controllable factors identified in this study can be used by hospital managers to implement measures that improve KAP among HCWs. Moreover, these measures should be customised, based on uncontrollable factors to suit the specific characteristics of medical staff and to improve KAP. Training programmes should be designed for medical workers to increase their awareness of HAIs and to foster positive attitudes and practices.

IntroductionInappropriate antimicrobial use increases the prevalence of antimicrobial-resistant bacteria. Surgeons are reluctant to implement recommendations of guidelines in clinical practice. Antimicrobial stewardship (AMS) is effective in antimicrobial management, but it remains labour intensive. The computerised decision support system (CDSS) has been identified as an effective way to enable key elements of AMS in clinical settings. However, insufficient evidence is available to evaluate the efficacy of computerised AMS in surgical settings.Methods and analysisThe Evaluate of the Potential Impact of Computerised AMS trial is an open-label, single-centre, two-arm, cluster-randomised, controlled trial, which aims to determine whether a multicomponent CDSS intervention reduces overall antimicrobial use after cardiovascular surgeries compared with usual clinical care in a specialty hospital with a big volume of cardiovascular surgeries. Eighteen cardiovascular surgical teams will be randomised 1:1 to either the intervention or the control arm. The intervention will consist of (1) re-evaluation alerts and decision support for the duration of antimicrobial treatment decision, (2) re-evaluation alerts and decision support for the choice of antimicrobial, (3) quality control audit and feedback. The primary outcome will be the overall systemic antimicrobial use measured in days of therapy (DOT) per admission and DOT per 1000 patient-days over the whole intervention period (6 months). Secondary outcomes include a series of indices to evaluate antimicrobial use, microbial resistance, perioperative infection outcomes, patient safety, resource consumption, and user compliance and satisfaction.Ethics and disseminationThe Ethics Committee in Fuwai Hospital approved this study (2020-1329). The results of the trial will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT04328090.

ObjectivesSeveral physiological abnormalities that develop during COVID-19 are associated with increased mortality. In the present study, we aimed to develop a clinical risk score to predict the in-hospital mortality in COVID-19 patients, based on a set of variables available soon after the hospitalisation triage.SettingRetrospective cohort study of 516 patients consecutively admitted for COVID-19 to two Italian tertiary hospitals located in Northern and Central Italy were collected from 22 February 2020 (date of first admission) to 10 April 2020.ParticipantsConsecutive patients≥18 years admitted for COVID-19.Main outcome measuresSimple clinical and laboratory findings readily available after triage were compared by patients’ survival status (‘dead’ vs ‘alive’), with the objective of identifying baseline variables associated with mortality. These were used to build a COVID-19 in-hospital mortality risk score (COVID-19MRS).ResultsMean age was 67±13 years (mean±SD), and 66.9% were male. Using Cox regression analysis, tertiles of increasing age (≥75, upper vs 2/FiO2 (HR 0.995 per unit increase; pConclusionsThe COVID-19MRS is a rapid, operator-independent and inexpensive clinical tool that objectively predicts mortality in patients with COVID-19. The score could be helpful from triage to guide earlier assignment of COVID-19 patients to the most appropriate level of care.

ObjectivesThis study aimed to set a data-driven achievable performance benchmark, explore the process–outcome association and speculate about the net gain in quality improvement with benchmarking.DesignObservational study.SettingPatient survey conducted at 466 secondary and tertiary hospitals across 31 provinces, autonomous regions and municipalities in China.Participants183 334 patients diagnosed with chronic heart failure (CHF) who were treated at 466 Chinese hospitals from January 2011 through May 2017.Primary independent variablesHospital process composite performance (HPCP).Secondary independent variablesPatient-level and hospital-level characteristics.Primary outcome measurePatients getting better or recovered after treatment, in-hospital mortality, length of hospital stay (LOS) and medical cost.MethodsHPCP was calculated using denominator-based weights. Mixed random-intercept models were used to evaluate the contributions of HPCP on patient outcomes and to speculate quality improvement after adjusting HPCP to benchmark level.ResultsWhen all hospitals were to operate at the benchmark level, the proportion of patients getting better or recovered after treatment would increase in most hospitals, particularly those with low baseline rates. However, there was no evidence for lowering in-hospital mortality, significant savings in cost or shortening LOS.ConclusionsIncreasing the adherence rate of CHF care and closing the gap in HPCP between hospitals have important implications for improving patient condition.

IntroductionThis clinical trial is designed to evaluate the effect of multiple-dose tranexamic acid (TXA) on perioperative blood loss in patients with rheumatoid arthritis (RA).Methods and analysisA randomised, single-blinded, parallel-controlled study will be designed. Patients with RA (age 50–75 years) undergoing unilateral primary end-stage total knee arthroplasty will be randomly divided into group A or group B. Group A will be treated with one dose of TXA (1 g; intravenous injection 3 hours postsurgery) and group B with three doses (1 g; intravenous injection at 3, 6 and 12 hours postsurgery) after surgery. The primary outcomes will be evaluated with blood loss, maximum haemoglobin drop and transfusion rate. The secondary outcomes will be evaluated with knee function and complications.Ethics and disseminationThe Shanghai Guanghua Hospital of Integrated Traditional Chinese Medicine and Western Medicine Ethics Committee approved in this study in July 2019. Informed consent will be obtained from all participants. Results of the trial will be published in the Dryad and repository in a peer-reviewed journal. Additionally, deidentified data collected and analysed for this study will be available for review from the corresponding author on reasonable request.Trial registration numberChiCTR1900025013.

Objective The influx of management ideas into healthcare has triggered considerable debate about if and how managerial and medical logics can coexist. Recent reviews suggest that clinician involvement in hospital management can lead to superior performance. We, therefore, sought to systematically explore conditions that can either facilitate or impede the influence of medical leadership on organisational performance. Design Systematic review using thematic synthesis guided by the Enhancing Transparency in Reporting the synthesis of Qualitative research statement. Data sources We searched PubMed, Web of Science and PsycINFO from 1 January 2006 to 21 January 2020. Eligibility criteria We included peer-reviewed, empirical, English language articles and literature reviews that focused on physicians in the leadership and management of healthcare. Data extraction and synthesis Data extraction and thematic synthesis followed an inductive approach. The results sections of the included studies were subjected to line-by-line coding to identify relevant meaning units. These were organised into descriptive themes and further synthesised into analytic themes presented as a model. Results The search yielded 2176 publications, of which 73 were included. The descriptive themes illustrated a movement from 1. medical protectionism to management through medicine; 2. command and control to participatory leadership practices; and 3. organisational practices that form either incidental or willing leaders. Based on the synthesis, the authors propose a model that describes a virtuous cycle of management through medicine or a vicious cycle of medical protectionism. Conclusions This review helps individuals, organisations, educators and trainers better understand how medical leadership can be both a boon and a barrier to organisational performance. In contrast to the conventional view of conflicting logics, medical leadership would benefit from a more integrative model of management and medicine. Nurturing medical engagement requires participatory leadership enabled through long-term investments at the individual, organisational and system levels.

Objective This study can be applied to cost the complex non-standardised processes used to treat patients with multiple chronic conditions. Design A mixed-method approach to cost analysis, following a modified healthcare-specific version of the seven-step Time-Driven Activity-Based Costing (TDABC) approach. Setting A multidisciplinary integrated and person-centred care delivery centre at a university-affiliated tertiary teaching hospital in Stockholm, Sweden, designed to improve care coordination for patients with multiple chronic conditions, specifically diabetes, cardiovascular disease and kidney disease. Participants 314 patients (248 men and 66 women) fit inclusion criteria. Average age was 80 years. Results This modified TDABC analysis costed outpatient care for patients with multiple chronic conditions. The approach accounted for the difficulty of conceptualising care cycles. The estimated total cost, stratified by resources, can be reviewed together with existing managerial accounting statements to inform management decisions regarding the multidisciplinary centre. Conclusions This article demonstrates that the healthcare-specific seven-step approach to TDABC can be applied to cost care for patients with multiple chronic conditions, where pathways are not yet discernable. It became clear that there was a need for slight methodological adaptations for this particular patient group to make it possible to cost these pathways, stratified by activity and resource. The value of this approach can be discerned from the way management incorporated the results of this analysis into the development of their hospital strategy. In the absence of integrated data infrastructures that can link patients and resources across financial, clinical and process data sets, the scalability of this method will be difficult.

IntroductionChronic pain and co-occurring disorders, such as sleep disorders, anxiety, depression, post-traumatic stress disorder and substance use disorders, are among the most common conditions for which cannabis and cannabinoid-based products derived from the cannabis plant (CBP) are used for therapeutic purposes. However, healthcare providers report that they lack sufficient information on the risks, benefits and appropriate use of cannabis and CBP derived from the cannabis plant for therapeutic purposes.Methods and analysisWe will conduct a systematic review of studies investigating the use of cannabis and CBP derived from the cannabis plant for the treatment of chronic pain and co-occurring conditions. Randomised controlled trials, meta-analyses and observational studies will be prioritised. We will exclude reviews of cannabinoid mechanisms of actions, commentary articles and narrative reviews. The primary outcome of interest will be efficacy in relieving chronic pain. Secondary outcomes will be efficacy in ameliorating conditions such as sleep disorders, anxiety, depression, post-traumatic stress disorder and substance use disorders. We will search electronic bibliographic databases including Academic Search Complete, Cochrane Database of Systematic Reviews, Evidence based Medicine Reviewes, OVID Medline, PsychINFO, PubMed, CINAHL and Web of Science. Two reviewers will conduct screening and data collection independently. Study level of bias will be assessed using the Cochrane Risk of Bias Assessment Tool for randomised controlled trials and non-randomised studies. Narrative analysis will be utilised to interpret the data.Ethics and disseminationThe results of this systematic review will inform guideline development for the use of cannabis and CBP derived from the cannabis plant in the management of chronic pain and co-occurring conditions. Areas requiring further study will also be highlighted.PROSPERO registration numberCRD42020135886.

ObjectivesThis scoping review aimed to describe available interventions for decreasing (post-traumatic stress disorder) PTSD symptoms among healthcare professionals in hospital care.MethodA scoping review was conducted following Arksey and O’Malley’s framework. PubMed, EMBASE, Cochrane Library, CINAHL, PsycINFO, Web of Science, Scopus and ProQuest were searched for original research published in English from 2011 to 2021, on 8 July 2021. We included studies that described interventions that focused on reducing the PTSD symptoms of healthcare professionals. A narrative synthesis was adopted to synthesise the data.ResultsA total of eight studies out of 2558 articles were identified. Six used a quantitative study design and two adopted qualitative methods. cognitive behavioural therapy and mindfulness-based interventions were the most commonly adopted. Most studies used a combination of different intervention strategies. Trauma-related knowledge, emotion regulation and relaxation skill training, and psychological support from peers and psychologists were three core intervention components. The duration ranged from 2 weeks to 6 months. Healthcare professionals who participated in training programmes reported both positive experiences and suggestions for the improvement of PTSD-reducing interventions in their qualitative feedback.ConclusionsThe scoping review provides a practical summary of the intervention characteristics for reducing the PTSD symptoms of healthcare professionals. Hospitals and managers could use the overview of interventions to assist healthcare professionals with PTSD symptoms. More research investigating the effects of PTSD symptom-reducing interventions for healthcare professionals with appropriate follow-up assessments is needed in the future.

ObjectivesThis study aims to analyse, from a descriptive and qualitative point of view, the episodes of violence reported by healthcare workers (HCWs) in a large public Italian hospital. Qualitative analysis permits us to collect the victims’ words used to describe the event and the ways in which they dealt with it. A comparison between genders was performed to better understand what type of different strategies could be used to improve the prevention of workplace violence for HCWs.Design and settingThe retrospective observational study was carried out in ‘Città della Salute e della Scienza’, a complex of four interconnected hospitals situated in Northern Italy. This study analysed aggression data from the 4-year period of 2015–2018 that included all HCW categories. The data were obtained from the aggression reporting form.ParticipantsThe analysed records were supplied by 396 HCWs (3.6% of all HCWs in the hospital).ResultsMale HCWs aged ConclusionsThe findings from this explorative study suggest that there is a gender difference in the characteristics of workplace violence perpetrated by patients, patients’ relatives and visitors and in the way in which these episodes are described. Consequently, it is important for informative and preventive courses to consider gender differences in experiencing a violent episode.

ObjectivesTo determine if there is an association between acuity level of care (ALC), case fatality and length of stay in patients admitted to hospital due to COVID-19.DesignA hospital-based observational follow-up study.SettingInternal Medicine Service of the Aga Khan University Hospital, Pakistan, from 26 February 2020 to 30 June 2020.ParticipantsAdult patients with confirmed COVID-19, aged ≥18 years.MethodsALC was categorised into low, intermediate and high level and patients were triaged using the standard emergency severity illness score. All patients were followed until the end of hospital admission for the outcome of case fatality and length of stay.ResultsA total of 822 patients with COVID-19 were admitted during the study period and 699 met inclusion criteria. The mean age was 54.5 years and 67% were males; 50.4% were triaged to low, 42.5% to intermediate and 7.2% to high acuity care. The overall case-fatality rate was 11.6%, with the highest (52%) in high acuity level followed by 16.2% in intermediate and 2% in low acuity care. Acuity level was associated with case fatality, with an HR (95% CI) of 5.0 (2.0 to 12.1) for high versus low acuity care and an HR of 2.7 (1.2, 6.4) for intermediate versus low acuity care, after adjusting for age, sex and common comorbidities including diabetes, hypertension, ischaemic heart disease and chronic lung disease. Similarly, acuity level was also associated with length of hospital stay.ConclusionHigh and intermediate acuity level is associated with higher case fatality rate and prolonged length of hospital stay in patients admitted with COVID-19. In resource-limited settings where the provision of high acuity care is limited, the intermediate care acuity could serve as a useful strategy to treat relatively less critical patients with COVID-19.

ObjectiveOur study compares physician judgement with an automated early warning system (EWS) for predicting clinical deterioration of hospitalised general internal medicine patients.DesignProspective observational study of clinical predictions made at the end of the daytime work-shift for an academic general internal medicine floor team compared with the risk assessment from an automated EWS collected at the same time.SettingInternal medicine teaching wards at a single tertiary care academic medical centre in the USA.ParticipantsIntern physicians working on the internal medicine wards and an automated EWS (Rothman Index by PeraHealth).OutcomeClinical deterioration within 24 hours including cardiac or pulmonary arrest, rapid response team activation or unscheduled intensive care unit transfer.ResultsWe collected predictions for 1874 patient days and saw 35 clinical deteriorations (1.9%). The area under the receiver operating curve (AUROC) for the EWS was 0.73 vs 0.70 for physicians (p=0.571). A linear regression model combining physician and EWS predictions had an AUROC of 0.75, outperforming physicians (p=0.016) and the EWS (p=0.05).ConclusionsThere is no significant difference in the performance of the EWS and physicians in predicting clinical deterioration at 24 hours on an inpatient general medicine ward. A combined model outperformed either alone. The EWS and physicians identify partially overlapping sets of at-risk patients suggesting they rely on different cues or decision rules for their predictions.Trial registration numberNCT02648828.

ObjectivesPrevious studies have shown that symptoms of sleep-disordered breathing are associated with metabolic derangements and vascular disease development. However, the relationship between snoring and renal function is not well investigated. The association between snoring and the development of incident chronic kidney disease (CKD) in subjects with normal renal function was evaluated.DesignProspective cohort study.SettingAnsung (rural community) and Ansan (urban community) cities.ParticipantsCommunity-based cohort participants aged 40–69 years.MethodsA total of 9062 participants in the Ansung–Ansan cohort study were prospectively followed up from 2001 to 2014. The participants were classified into three groups: non-snorer, 2during the follow-up period.Primary outcomeIncident CKD.ResultsThe mean subject age was 52.0±8.9 years, and 4372 (48.2%) subjects were male. The non-snorer,ConclusionSnoring may increase the risk of CKD development in subjects with normal renal function.

ObjectivesTo assess the degree to which variations in publicly reported hospital scores arising from the English Cancer Patient Experience Survey (CPES) are subject to chance.DesignSecondary analysis of publically reported data.SettingEnglish National Health Service hospitals.Participants72 756 patients who were recently treated for cancer in one of 146 hospitals and responded to the 2016 English CPES.Main outcome measuresSpearman-Brown reliability of hospital scores on 51 evaluative questions regarding cancer care.ResultsHospitals varied in respondent sample size with a median hospital sample size of 419 responses (range 31–1972). There were some hospitals with generally highly reliable scores across most questions, whereas other hospitals had generally unreliable scores (the median reliability of question scores within individual hospitals varied between 0.11 and 0.86). Similarly, there were some questions with generally high reliability across most hospitals, whereas other questions had generally low reliability. Of the 7377 individual hospital scores publically reported (146 hospitals by 51 questions, minus 69 suppressed scores), only 34% reached a reliability of 0.7, the minimum generally considered to be useful. In order for 80% of the individual hospital scores to reach a reliability of 0.7, some hospitals would require a fourfold increase in number of respondents; although in a few other hospitals sample sizes could be reduced.ConclusionsThe English Patient Experience Survey represents a globally unique source for understanding experience of a patient with cancer; but in its present form, it is not reliable for high stakes comparisons of the performance of different hospitals. Revised sampling strategies and survey questions could help increase the reliability of hospital scores, and thus make the survey fit for use in performance comparisons.

Introduction The purpose of this study is to assess the efficacy of electroacupuncture (EA) to relieve pain and promote functional rehabilitation after total knee surgery. Methods and analysis We propose a single-blinded, randomised placebo-controlled trial to evaluate the efficacy of EA. Patients with osteoarthritis (aged 55–80 years) undergoing unilateral total knee arthroplasty (TKA) will be included in the trial. They will be randomised to receive either EA or sham-EA. A total of 110 patients will receive EA and sham-EA for 3 days after TKA. Postoperative pain will be measured using visual analogue score, and the need for an additional dose of opioid and analgesics will be recorded as the primary outcome. Secondary outcomes include knee function and swelling, postoperative anxiety, postoperative nausea and vomiting among other complications. Ethics and dissemination This study has been approved by the ethics committee, and subsequent modifications of the protocol will be reported and approved by it. Written informed consent will be obtained from all of the participants or their authorised agents. Trial registration number ChiCTR1800016200; Pre-results.

ObjectivesLittle is known regarding how natural disasters affect patients with cancer in low-income and middle-income countries. The objective of the present study was to assess the impact of the 2015 Nepal earthquake on the admission of patients with cancer at a core medical institution in Kathmandu.Design, setting and participantsWe considered all 3520 cancer patient admissions to Tribhuvan University Teaching Hospital, from 25 April 2013 to 24 April 2017 (2 years before and 2 years after the earthquake).Outcome measuresThe number of cancer patient admissions was calculated for each month. Using a negative binomial model, we estimated the incidence rate ratio (IRR) for admission numbers each month after the earthquake compared with the pre-earthquake baseline and investigated chronological change.ResultsThe total admission number in the first month after the earthquake was decreased compared with that of the predisaster baseline (IRR=0.66, 95% CI 0.43 to 1.00), which largely reflected decreased admissions of patients from outside of the most disaster-affected districts. From the second month, the admission number consistently exceeded the predisaster baseline for the remaining postdisaster period. In contrast to the month of the disaster, the continuation of increased admissions was most prominent among those from outside of the most affected districts.ConclusionsAfter a transient decrease immediately following the 2015 Nepal earthquake, there was a long-term increase in cancer patient admissions in a core hospital in Kathmandu. These changes were seen most prominently in patients from outside the most disaster affected areas.

ObjectivesHospitals devoted to maternal and child health represent unique healthcare institutions in China. Healthcare professionals in these hospitals attend to health services for women and children, and also provide technical services and support for district maternal and children’s healthcare as well as family planning. However, few studies have examined occupational burnout among doctors employed in these hospitals. This research addresses the gap in the literature.MethodsA cross-sectional survey of obstetricians and paediatricians from 11 maternal and child health hospitals across China was conducted May through June 2017. A total of 678 people completed a self-administered questionnaire. The survey included questions about demographics, doctor–patient relationships and networks of support as well as characteristics designed to capture the occurrence of burnout, such as emotional exhaustion, cynicism and professional efficacy. T-test, variance and multiple regression analyses were used to examine the data.ResultsThe research revealed that 56.6% of obstetricians and paediatricians exhibited signs of occupational burnout. Poor doctor–patient relationships and high average number of weekly hours worked contributed to burnout. Additionally, low family support corresponded to physicians’ low sense of professional efficacy.ConclusionsSeveral factors have contributed to occupational burnout among paediatricians and obstetricians at maternal and child health hospitals in China, including lack of family support, poor doctor–patient relationships and heavy workloads.

IntroductionPlantar fasciitis (PF) is reported to be the most common cause of plantar heel pain. Acupuncture has been used for patients experiencing PF, but evidence of the efficacy of acupuncture on PF is limited. The primary objective of this trial is to compare combined acupuncture and sham acupuncture (SA) versus waitlist control for improving the level of pain experienced by patients suffering from chronic PF.Methods and analysisThis will be a two-centre, parallel-group, sham and no-treatment controlled, assessor-blinded randomised trial. We will randomly allocate 120 participants with chronic PF to acupuncture, SA and waitlist control groups at a ratio of 2:1:1. Participants in the acupuncture and SA groups will receive a 30 min acupuncture or SA treatment for a total of 12 sessions over 4 weeks, with a 12-week follow-up. Participants in the waitlist control group will not undergo treatment for a period of 16 weeks but instead will have the option of 4 weeks (12 sessions) of acupuncture free of charge at the end of the follow-up period. The primary outcome will be the treatment response rate 4 weeks after randomisation, assessed as a minimum of 50% improvement in the worst pain intensity during the first steps in the morning compared with the baseline. All analyses will be performed with a two-sided p value of Ethics and disseminationThe study has been approved by the Ethical Committee of the Guang’anmen Hospital, China Academy of Chinese Medical Sciences (approval no. 2019-210-KY). The results will be disseminated through presentation at a peer-reviewed medical journal, the relevant conferences and scientific meetings.Trial registrationNCT04185259.

IntroductionCarotid endarterectomy (CEA), carotid artery stenting (CAS) and best medical therapy (BMT) are the major treatments used for significant asymptomatic carotid artery stenosis (ACAS, ≥50%). However, the widespread use of lipid-lowering drugs in this century has improved BMT outcomes. This study aims to compare the treatment efficacy of current BMT, CEA+BMT and CAS+BMT in patients with significant ACAS.Methods and analysisThis protocol was designed based on the guidelines of the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Publication time for studies will be set from 1 January 2000 to 1 June 2020. We will search three databases: PubMed, EMBASE and The Cochrane Library. Suitable randomised controlled studies will be screened. The primary outcomes will include short-term and long-term mortality, stroke and myocardial infarction. OR and HR for dichotomous data and time-to-event data with 95% CIs will be calculated. Treatment effects among different therapies will be ranked according to the surface under the cumulative ranking curve and mean rank. A comprehensive evaluation of the risk of bias, heterogeneity and transitivity will be performed before data synthesis. Consistency and evidence quality will also be assessed.Ethics and disseminationThere will be no need for ethics approval as this systematic review is a summary and analysis of existing literature. Final results may be presented in international conferences or a peer-reviewed journal.PROSPERO registration numberCRD42019138942.

ObjectiveTo evaluate whether oral ciprofloxacin, levofloxacin, ofloxacin and moxifloxacin increase the risk of ventricular arrhythmia in Korea’s general population.DesignPopulation-based cohort study using administrative claims data on a national scale in Korea.SettingAll primary, secondary and tertiary care settings from 1 January 2015 to 31 December 2015.ParticipantsPatients who were prescribed the relevant study medications at outpatient visits.Primary outcome measuresEach patient group that was prescribed ciprofloxacin, levofloxacin, ofloxacin or moxifloxacin was compared with the group that was prescribed cefixime to assess the risk of serious ventricular arrhythmia (ventricular tachycardia, fibrillation, flutter and cardiac arrest). Using logistic regression analysis with inverse probability of treatment weighting using the propensity score, OR and 95% CI for serious ventricular arrhythmia were calculated for days 1–7 and 8–14 after the patients commenced antibiotic use.ResultsDuring the study period, 4 888 890 patients were prescribed the study medications. They included 1 466 133 ciprofloxacin users, 1 141 961 levofloxacin users, 1 830 786 ofloxacin users, 47 080 moxifloxacin users and 402 930 cefixime users. Between 1 and 7 days after index date, there was no evidence of increased serious ventricular arrhythmia related to the prescription of ciprofloxacin (OR 0.72; 95% CI 0.49 to 1.06) and levofloxacin (OR 0.92; 95% CI 0.66 to 1.29). Ofloxacin had a 59% reduced risk of serious ventricular arrhythmia compared with cefixime during 1–7 days after prescription. Whereas the OR of serious ventricular arrhythmia after the prescription of moxifloxacin was 1.87 (95% CI 1.15 to 3.11) compared with cefixime during 1–7 days after prescription.ConclusionsDuring 1–7 days after prescription, ciprofloxacin and levofloxacin were not associated with increased risk and ofloxacin showed reduced risk of serious ventricular arrhythmia. Moxifloxacin increased the risk of serious ventricular arrhythmia.

IntroductionPrimary membranous nephropathy (MN) is a common cause of nephrotic syndrome in adults. The disease may have different long-term outcomes. After 10 years of follow-up, 35%–50% of the untreated patients with persistent nephrotic syndrome may die or progress to end stage renal disease. The 2012 KDIGO (Kidney Disease Improving Global Outcomes) guidelines recommend that initial therapy should consist of alternating steroids and an alkylating agent for 6 months. Recent observational studies showed that the anti-CD20 antibody rituximab may be effective in inducing remission. We designed a pilot multicentre randomised trial to inform the design of a larger trial testing the efficacy and safety of treatment with steroids and cyclophosphamide versus rituximab in patients with primary MN and heavy proteinuria (>3.5 g/24 hours).Methods and analysisThis pilot, open-label, two-parallel-arm, randomised clinical trial will enrol 70 patients with primary MN and heavy proteinuria. Patients will be randomised in a 1:1 ratio to either the intervention arm (rituximab) or the active comparator arm (corticosteroid/alkylating-agent therapy). The study will provide estimates of the probability of complete remission of proteinuria and risk of serious side effects at 12 months to inform the design of a larger trial. We will also assess the recruitment potential of each participating centre to address study feasibility.Ethics and disseminationThe trial received ethics approval from the local ethics boards. We will publish pilot data to inform the design of a larger clinical trial.Trial registration numbersNCT03018535; 2011-006115-59.

ObjectivesDoctor–patient conflict is a phenomenon that has become one of the major social problems affecting China’s medical system today. This study aimed to analyse the nature of medical dispute incidents arising from dental practice, discover the related factors that may have incited such disputes and explore measures whereby the incidents of patients’ conflicts towards dentists can be reduced.MethodsA survey conducted in six public hospitals in Guangzhou, one of the largest cities in China, showed that more than two million patients received dental treatment between 2008 and 2012. χ2test and binary logistic regression analysis were used to identify statistically significant differences in incident rates.ResultsIn a total of more than two million outpatients, 541 reported dental disputes and lodged complaints with the medical service centre. Male patients reported higher dispute rates than did females (χ2=9.74, PConclusionsGender, specialties, cause of dispute, mode of payment and resolution duration are associated with the incidence of dental conflicts, suggesting that medical quality is positively correlated to dental disputes, the coverage of stomatology in medical insurance should be expanded and detailed negotiation system should be developed for resolving dental disputes.

ObjectivesIt has been proven that statin can protect synovial joints from developing osteoarthritis through its anti-inflammatory effects. However, studies on the effect of statins on spinal degenerative joint diseases are few and limited to in vitro studies. Therefore, we investigated the relationship between the statin dosage and the development of spinal degenerative joint diseases.DesignA retrospective cohort study.SettingPatients registered in Taiwan National Health Insurance Research Database.ParticipantsPatients aged 40–65 years old from 2001 to 2010 were included. Those who received statin treatment before 2001, were diagnosed with spinal degenerative joint diseases or received any spinal surgery before 2004 or had any spinal trauma before 2011 were excluded. A total of 7238 statin users and 164 454 non-users were identified and followed up for the next 7 years to trace the development of spinal degenerative joint disease.Outcome measuresThe incident rate of spinal degenerative joint diseases and HRs among the groups treated with different statin dosages.ResultsA higher dosage of statins was associated with a significantly lower risk of developing spinal degenerative joint disease in patients with hypercholesterolaemia. Compared with the group receiving less than 5400 mg of a statin, the HR of the 11 900–28 000 mg group was 0.83 (95% CI 0.70 to 0.99), and that of the group receiving more than 28 000 mg was 0.81 (95% CI 0.68 to 0.97). Results of subgroup analysis showed a significantly lower risk in men, those aged 50–59 years and those with a monthly income less than US$600.ConclusionsOur study’s findings clearly indicated that a higher dosage of statins can reduce the incidence of spinal degenerative joint disease in patients with hypercholesterolaemia, and it can be beneficial for people with a higher risk of spine degeneration.

ObjectiveClinics have been established to provide preoperative medical consultations, and enable the anaesthetist and surgeon to deliver the best surgical outcome for patients. However, there is uncertainty regarding the effect of such clinics on surgical, in-hospital and long-term outcomes. A systematic review of the literature was conducted to determine the effectiveness of preoperative medical consultations by internal medicine physicians for patients listed for elective surgery.DesignSystematic searches of MEDLINE, EMBASE, CINAHL, PubMed, Current Contents and the NHS Centre for Reviews and Dissemination were conducted up to 30 April 2017.SettingElective surgery.Study selectionRandomised controlled trials and non-randomised comparative studies conducted in adults.Outcome measuresLength of hospital stay, perioperative morbidity and mortality, costs and quality of life.ResultsThe one randomised trial reported that preadmission preoperative assessment was more effective than the option of an inpatient medical assessment in reducing the frequency of unnecessary admissions with significantly fewer surgical cancellations following admission for surgery. A small reduction in length of stay in patients was also observed. The three non-randomised studies reported increased lengths of stay, costs and postoperative complications in patients who received preoperative assessment. The timing and delivery of the preoperative medical consultation in the intervention group differed across the included studies.ConclusionFurther research is required to inform the design and implementation of coordinated involvement of physicians and surgeons in the provision of care for high-risk surgical patients. A standardised approach to perioperative decision-making processes should be developed with a clear protocol or guideline for the assessment and management of surgical patients.

Introduction The numbers of patients with three or more chronic conditions (multimorbidity) are increasing, and will rise to 2.9 million by 2018 in the UK alone. Currently in the UK, conditions are mainly managed using over 250 sets of single-condition guidance, which has the potential to generate conflicting recommendations for lifestyle and concurrent medication for individual patients with more than one condition. To address some of these issues, we are developing a new computer-based tool to help manage these patients more effectively. For this tool to be applicable and relevant to current practice, we must first better understand how existing patients with multimorbidity are being managed, particularly relating to concerns over prescribing and potential polypharmacy. Methods and analysis Up to four secondary care centres, two community pharmacies and between four and eight primary care centres in the West Midlands will be recruited. Interviewees will be purposively sampled from these sites, up to a maximum of 30. In this mixed methods study, we will perform a dual framework analysis on the qualitative data; the first analysis will use the Theoretical Domains Framework to assess barriers and enablers for healthcare professionals around the management of multimorbid patients; the second analysis will use Normalisation Process Theory to understand how interventions are currently being successfully implemented in both settings. We will also extract quantitative anonymised patient data from primary care to determine the extent of polypharmacy currently present for patients with multimorbidity in the West Midlands. Discussion We aim to combine these data so that we can build a useful, fully implementable tool which addresses the barriers most amenable to change within both primary and secondary care contexts. Ethics and dissemination Favourable ethical approval has been granted by The University of Birmingham Research Ethics Committee (ERN_16–0074) on 17 May 2016. Our work will be disseminated through peer-reviewed literature, trade journals and conferences. We will also use the dedicated web page hosted by the University to serve as a central point of contact and as a repository of our findings. We aim to produce a minimum of three articles from this work to contribute to the international scientific literature. Protocol registration number NIHR Clinical Research Network Portfolio Registration CPMS ID 30613.

IntroductionDespite common assumptions that doctors are well placed to lead hospitals and healthcare organisations, the peer-reviewed literature contains little evidence on the performance of doctors in leadership roles in comparison with that of non-medical managers.ObjectivesTo determine whether there is an association between the leader’s medical background and management performance in terms of organisational performance or patient outcomes.MethodsWe searched for peer-reviewed, English language studies using Medline, Embase and Emerald Management between 2005 and 2017. We included quantitative, qualitative and mixed method empirical studies on the performance of senior healthcare managers where participants were described as doctors or leaders and where comparative performance data were provided on non-medical leaders. Studies without full text available, or no organisational, leadership behaviour or patient measures, were excluded.ResultsThe search, conducted in Medline (n=3395), Embase (n=1913) and Emerald Management (n=454) databases, yielded 3926 entries. After the application of inclusion and exclusion criteria, 16 studies remained. Twelve studies found that there were positive differences between medical and non-medical leaders, and eight studies correlated those findings with hospital performance or patient outcomes. Six studies examined the composition of boards of directors; otherwise, there were few common areas of investigation. Five inter-related themes emerged from a narrative analysis: the impact of medical leadership on outcomes; doctors on boards; contribution of qualifications and experience; the medical leader as an individual or part of a team and doctors transitioning into the medical leadership role.Discussion and conclusionA modest body of evidence supports the importance of including doctors on organisational governing boards. Despite many published articles on the topic of whether hospitals and healthcare organisations perform better when led by doctors, there were few empirical studies that directly compared the performance of medical and non-medical managers. This is an under-researched area that requires further funding and focus.

IntroductionLeft ventricular ejection fraction (LVEF) ≤35%, as current significant implantable cardioverter-defibrillator (ICD) indication for primary prevention of sudden cardiac death (SCD) in heart failure (HF) patients, has been widely recognised to be inefficient. Improvement of patient selection for low LVEF (≤35%) is needed to optimise deployment of ICD. Most of the existing prediction models are not appropriate to identify ICD candidates at high risk of SCD in HF patients with low LVEF. Compared with traditional statistical analysis, machine learning (ML) can employ computer algorithms to identify patterns in large datasets, analyse rules automatically and build both linear and non-linear models in order to make data-driven predictions. This study is aimed to develop and validate new models using ML to improve the prediction of SCD in HF patients with low LVEF.Methods and analysisWe will conduct a retroprospective, multicentre, observational registry of Chinese HF patients with low LVEF. The HF patients with LVEF ≤35% after optimised medication at least 3 months will be enrolled in this study. The primary endpoints are all-cause death and SCD. The secondary endpoints are malignant arrhythmia, sudden cardiac arrest, cardiopulmonary resuscitation and rehospitalisation due to HF. The baseline demographic, clinical, biological, electrophysiological, social and psychological variables will be collected. Both ML and traditional multivariable Cox proportional hazards regression models will be developed and compared in the prediction of SCD. Moreover, the ML model will be validated in a prospective study.Ethics and disseminationThe study protocol has been approved by the Ethics Committee of the First Affiliated Hospital of Nanjing Medical University (2017-SR-06). All results of this study will be published in international peer-reviewed journals and presented at relevant conferences.Trial registration numberChiCTR-POC-17011842; Pre-results.

ObjectivesThe purpose of this study was to examine the expectations of patients attending an urban primary care out-of-hours (OOH) facility with acute upper respiratory tract infection (acute URTI) regarding clinical examination, symptom management, information on their condition, reassurance, antibiotic treatment and other possible options including referral.DesignCross-sectional design.SettingOne urban primary care OOH facility located in the midwest of Ireland.Participants457 patients filled out a questionnaire while waiting in the OOH facility; 22 surveys were excluded as the patients did not present with symptoms of acute URTI resulting in 435 patients’ data being included in this study. There were 59.5% female participants and 40.5% male participants.Results435 patients with acute URTI symptoms participated in the survey, representing 25.4% of those attending the single branch where the survey was conducted (n=1715). Of the study participants, 43% were aged under 6 years and 60% were women. The most common presenting symptoms were cough (72%), throat ache (46%) and common cold (26%). The most common expectations were for further examination (53%), reassurance (51%), information (49%) and medication for cough (47%), with 34% expecting an antibiotic.ConclusionsOnly one in three patients attending this primary care OOH facility with acute URTI symptoms had an expectation of antibiotics, with most seeking further assessment, information and reassurance. Recognition of such expectations may be important considerations for clinicians when deciding on management options for patients with acute URTI.

ObjectivesCrew resource management (CRM) training formats have become a popular method to increase patient safety by consideration of the role that human factors play in healthcare delivery. The purposes of this review were to identify what is subsumed under the label of CRM in a healthcare context and to determine how such training is delivered and evaluated.DesignSystematic review of published literature.Data sourcesPubMed, PsycINFO and ERIC were searched through 8 October 2018.Eligibility criteria for selecting studiesIndividually constructed interventions for healthcare staff that were labelled as CRM training, or described as based on CRM principles or on aviation-derived human factors training. Only studies reporting both an intervention and results were included.Data extraction and synthesisThe studies were examined and coded for relevant passages. Characteristics regarding intervention design, training conditions and evaluation methods were analysed and summarised both qualitatively and quantitatively.ResultsSixty-one interventions were included. 48% did not explain any keyword of their CRM intervention to a reproducible detail. Operating room teams and surgery, emergency medicine, intensive care unit staff and anaesthesiology came in contact most with a majority of the CRM interventions delivered in a 1-day or half-day format. Trainer qualification is reported seldomly. Evaluation methods and levels display strong variation.ConclusionsCritical topics were identified for the CRM training community and include the following: the need to agree on common terms and definitions for CRM in healthcare, standards of good practice for reporting CRM interventions and their effects, as well as the need for more research to establish non-educational criteria for success in the implementation of CRM in healthcare organisations.

Objectives\ud To examine which interventions healthcare professionals use to support patients with taking medicines and their perceptions about the effectiveness of those actions.\ud \ud Design\ud Cross-sectional multinational study.\ud \ud Setting\ud Online survey in Austria, Belgium, England, France, Germany, Hungary, The Netherlands, Poland, Portugal and Switzerland.\ud \ud Participants\ud A total of 3196 healthcare professionals comprising doctors (855), nurses (1047) and pharmacists (1294) currently registered and practising in primary care and community settings.\ud \ud Main outcome measures\ud Primary outcome: Responses to the question ‘I ask patients if they have missed any doses of their medication’ for each profession and in each country.\ud \ud Secondary outcome: Responses to 50 items concerning healthcare professional behaviour to support patients with medication-taking for each profession and in each country.\ud \ud Results\ud Approximately half of the healthcare professionals in the survey ask patients with long-term conditions whether they have missed any doses of their medication on a regular basis. Pharmacists persistently report that they intervene less than the other two professions to support patients with medicines. No country effects were found for the primary outcome.\ud \ud Conclusions\ud Healthcare professionals in Europe are limited in the extent to which they intervene to assist patients having long-term conditions with medication adherence. This represents a missed opportunity to support people with prescribed treatment. These conclusions are based on the largest international survey to date of healthcare professionals’ management of medication adherence.

ObjectivePulmonary oedema is recognised as a severe side effect of ritodrine hydrochloride. Recently, the number of twin pregnancies has been increasing. Few studies have reported the association between total dose of ritodrine hydrochloride prior to delivery and pulmonary oedema in twin pregnancy. We aimed to examine this association and determine the optimal cut-off threshold of total ritodrine hydrochloride dose to predict the incidence of pulmonary oedema in twin pregnancy based on obstetric records.DesignRetrospective cohort study.SettingYamanashi Prefectural Central Hospital, Japan.ParticipantsTwo hundred and twenty-six women with twin pregnancy who delivered at Yamanashi Prefectural Central Hospital between September 2009 and November 2016.MethodsThe obstetric records of the participants were analysed. We defined 1 unit of ritodrine hydrochloride as 72 mg per 24 hours continuous transfusion at 50 µg/min to calculate the dose of ritodrine used for tocolysis.Outcome measuresMultivariable logistic regression analysis was performed to examine the association between total dose of ritodrine hydrochloride used for threatened preterm labour and pulmonary oedema, while controlling for potential confounding factors. Then, a receiver–operating characteristic curve was used to determine the optimal cut-off of total ritodrine dose to predict pulmonary oedema incidence.ResultsMean maternal age was 32 (range, 18–46) years; 143 participants were nulliparous (63.3%), 109 had (48.2%) term deliveries and 194 (85.8%) had caesarean deliveries. The overall incidence of pulmonary oedema was 13.7% (31/226). Multivariable analysis showed that the total dose of ritodrine was significantly associated with pulmonary oedema (adjusted OR 1.02; 95% CI 1.004 to 1.03). The best cut-off point to predict the incidence of pulmonary oedema was 26 units (1872 mg) (sensitivity, 61.3%; specificity, 87.8%).ConclusionOur results suggest that consideration of the total dose of ritodrine hydrochloride is helpful in the management of patients with threatened preterm labour in twin pregnancy.

Introduction: while most respiratory tract infections (RTIs) will resolve without treatment, many children will receive antibiotics and some will develop severe symptoms requiring hospitalisation. There have been calls for evidence to reduce uncertainty regarding the identification of children who will and will not benefit from antibiotics. The aim of this feasibility trial is to test recruitment and the acceptance of a complex behavioural intervention designed to reduce antibiotic prescribing, and to inform how best to conduct a larger trial. Methods and analysis: the CHICO (Children's Cough) trial is a single-centre feasibility cluster randomised controlled trial (RCT) comparing a web-based, within-consultation, behavioural intervention with usual care for children presenting to general practitioner practices with RTI and acute cough. The trial aims to recruit at least 300 children between October 2014 and April 2015, in a single area in South West England. Following informed consent, demographic information will be recorded, and symptoms and signs measured. Parents/carers of recruited children will be followed up on a weekly basis to establish symptom duration, resource use and cost of the illness to the parent until the child's cough has resolved or up to 8 weeks, whichever occurs earlier. A review of medical notes, including clinical history, primary care reconsultations and hospitalisations will be undertaken 2 months after recruitment. The trial feasibility will be assessed by: determining acceptability of the intervention to clinicians and parent/carers; quantifying differential recruitment and follow-up; determining intervention fidelity; the success in gathering the data necessary to conduct a cost-effectiveness analysis; and collecting data about antibiotic prescribing rates to inform the sample size needed for a fully powered RCT. Ethics and dissemination: the study was approved by the North West--Haydock Research Ethics Committee, UK (reference number: 14/NW/1034). The findings from this feasibility trial will be disseminated through research conferences and peer-reviewed journals. Trial registration number ISRCTN23547970.

Objective To test the clinimetric properties and to evaluate the internal consistency, validity and reliability of the Polish version of the Knee injury and Osteoarthritis Outcome Score (KOOS) in older patients with end-stage knee osteoarthritis undergoing total knee replacement (TKR). Design and setting A prospective cohort study performed at the university hospital and the outpatient clinic. Methods The patients were asked to complete the KOOS questionnaire and the Short Form 36 Health Survey. We evaluated floor/ceiling effects, reliability (using Cronbach9s α, intraclass correlation coefficients (ICC) and measurement error), structural validity (performing exploratory principal factor analysis), construct validity (with the use of 3 a priori hypotheses) and responsiveness (using data obtained before and after the surgery, and described by Global Perceived Effect, effect size and standardised response mean). Results The study consisted of 68 participants (mean age 68.8, 82% women). The floor effects were found prior to surgery for the subscales Sports and Recreation Function, and Quality of Life. The Cronbach9s α was from 0.90 to 0.92 for all subscales, indicating excellent internal consistency. The test–retest reliability at follow-up was excellent, with ICCs ranging from 0.81 to 0.86 for all KOOS subscales. The minimal detectable change ranged from 18.2 to 24.3 on an individual level and from 2.4 to 2.9 on a group level. All KOOS items were relevant, and all a priori established hypotheses were supported. Responsiveness was confirmed with a statistically significant correlation between all KOOS subscales and the Global Perceived Effect score (ranging from 0.56 to 0.70, p Conclusions The Polish version of KOOS demonstrated good reliability, validity and responsiveness for use in patient groups that had undergone TKR. Since the smallest change considered clinically relevant cannot reliably be detected in individual cases, the Polish version of KOOS is advocated for assessment of groups of patients.

ObjectivesClinical guidelines have been recognised as an effective way to improve healthcare performance. However, little is known about the uptake and implementation of guidelines by general practitioners in China. The aim of this study was to investigate the guideline use behaviours and needs of practitioners in primary care settings in China.MethodsWe conducted a cross-sectional survey from December 2015 to May 2016 that included practitioners at 268 institutions in 15 provinces in China. Questionnaire development was informed by the execution of a literature review and consultation of experts. On-site surveys were implemented using a paper questionnaire to minimise missing responses. A multivariate logistic regression analysis was performed to identify factors associated with provider knowledge of and attitudes towards clinical guidelines.ResultsOf the respondents, 91.7% (1568/1708) were aware of clinical guidelines, but only 11.3% (177/1568) frequently used them. The main mechanism by which primary care practitioners accessed guidelines was public search engines (63.4%; 911/1438), and practitioners seldom reported using biomedical databases. The most frequently identified barriers to guideline use were lack of training (49.9%; 778/1560), lack of access (44.6%; 696/1560) and lack of awareness (38.0%; 592/1560). Less than one-quarter of respondents considered current guidelines ‘entirely appropriate’ for use in primary care (23.5%; 339/1442). Most participants (96.2%; 1509/1568) believed it was necessary to develop primary care guidelines. Provider attitudes towards current guidelines were associated with the location and level of the institution and professional title of the practitioner (pConclusionOur survey revealed poor knowledge and uptake of clinical guidelines in primary care, and we identified a gap between the needs of practitioners and availability of clinical guidelines for use in primary care in China. In addition, lacking access to and training in guidelines also prevented primary healthcare practitioners from using guidelines in daily practice.

Objectives We sought to clarify how large a proportion of fatal medical accidents can be considered to be caused by poor non-technical skills, and to support development of a policy to reduce number of such accidents by making recommendations about possible training requirements. Design Summaries of reports of fatal medical accidents, published by the Japan Medical Safety Research Organization, were reviewed individually. Three experienced clinicians and one patient safety expert conducted the reviews to determine the cause of death. Views of the patient safety expert were given additional weight in the overall determination. Setting A total of 73 summary reports of fatal medical accidents were reviewed. These reports had been submitted by healthcare organisations across Japan to the Japan Medical Safety Research Organization between April 2010 and March 2013. Primary and secondary outcome measures The cause of death in fatal medical accidents, categorised into technical skills, non-technical skills and inevitable progress of disease were evaluated. Non-technical skills were further subdivided into situation awareness, decision making, communication, team working, leadership, managing stress and coping with fatigue. Results Overall, the cause of death was identified as non-technical skills in 34 cases (46.6%), disease progression in 33 cases (45.2%) and technical skills in two cases (5.5%). In two cases, no consensual determination could be achieved. Further categorisation of cases of non-technical skills were identified as 14 cases (41.2%) of problems with situation awareness, eight (23.5%) with team working and three (8.8%) with decision making. These three subcategories, or combinations of them, were identified as the cause of death in 33 cases (97.1%). Conclusions Poor non-technical skills were considered to be a significant cause of adverse events in nearly half of the fatal medical accidents examined. Improving non-technical skills may be effective for reducing accidents, and training in particular subcategories of non-technical skills may be especially relevant.

Objectives Using the findings of incident investigations to improve patient safety management is well-established and mandatory under Swedish law. This study seeks to identify the mechanisms behind successful implementation of the recommendations of incident investigations. Setting This study was based in a university hospital in southern Sweden. Participants A sample of 55 incident investigations from 2008 to 2010 were selected from the hospital's incident reporting system by staff in the office of the chief medical officer. These investigations were initiated by 23 different commissioning bodies and contained 289 separate recommendations. We used a three-stage method: content analysis to code the recommendations, semi-structured interviews with the commissioning bodies focusing on which recommendations had been implemented and why, and data analysis of the coded recommendations together with data from the interviews. Results We found that a clear majority (70%) of the recommendations presented to the commissioning bodies were targeted at the micro-level of the organisation. In nearly half (45%) of all recommendations, actions had been taken and a clear majority (73%) of these were at the micro-level. Changes in the management positions of the commissioning bodies meant that very little further action was taken. Other actions, independent of incident investigations, were often taken within the organisation. Conclusions We conclude that two principles (‘close in space’ and ‘close in time’) seem to be important for bridging the gap between recommendation and implementation. The micro-level focus was expected because of the method of investigation used. Adverse events trigger organisational action independently of incident investigations.

Objectives To investigate the association between rheumatoid arthritis (RA) and self-reported sleep duration. Setting The present study analysed 7 years of aggregated cross-sectional data (2007–2013) from the Korea National Health and Nutrition Examination Surveys (KNHANES). Participants A total of 37 979 individuals were selected for the analyses. Interventions RA. Primary and secondary outcome measures Sleep duration. Results After adjusting for confounding factors, the odds of short-duration sleepers (≤6 hours/day) and long-duration sleepers (≥9 hours/day) for RA were 1.23-fold (95% CI 1.101 to 1.51) and 1.27-fold (95% CI 0.85 to 1.88) higher, respectively, than those for persons with sleep duration of 7–8 hours/day. A subgroup analysis according to the extent of pain in RA revealed that the strong relationship between RA and sleep disturbances was observed in those with high pain from RA (OR: 1.28 CI 1.04 to 1.58). Conclusions Individuals with RA may be at a higher risk for sleep disturbances compared with individuals without RA. Therefore, the provision of comprehensive care for patients with RA by healthcare professionals should include assessments of sleep duration and patients with RA should be encouraged to report sleep problems.

Objective Phase IV trials are often used to investigate drug safety after approval. However, little is known about the characteristics of contemporary phase IV clinical trials and whether these studies are of sufficient quality to advance medical knowledge in pharmacovigilance. We aimed to determine the fundamental characteristics of phase IV clinical trials that evaluated drug safety using the ClinicalTrials.gov registry data. Methods A data set of 19 359 phase IV clinical studies registered in ClinicalTrials.gov was downloaded. The characteristics of the phase IV trials focusing on safety only were compared with those evaluating both safety and efficacy. We also compared the characteristics of the phase IV trials in three major therapeutic areas (cardiovascular diseases, mental health and oncology). Multivariable logistic regression was used to evaluate factors associated with the use of blinding and randomisation. Results A total of 4772 phase IV trials were identified, including 330 focusing on drug safety alone and 4392 evaluating both safety and efficacy. Most of the phase IV trials evaluating drug safety (75.9%) had enrolment

Objective: To test whether the relatively unpredictable nature of labour onset can be described by the Poisson distribution. Design: A descriptive retrospective study. Setting: From the Danish Birth Registry, we identified births from all seven obstetric clinics in the capital region of Denmark (n=211 290) between 2000 and the end of 2009. On each date, the number of births at each department was registered. Births are categorised based on whether an elective caesarean section or induction of labour has been performed, and among the remaining ‘non-elective births’, acute caesareans were registered. Methods: After the exclusion of elective caesarean sections and births after induction of labour, only ‘non-elective’ births (n=171 009) were included for the main statistical analysis. Simple descriptive plots and one-way analysis of variance were used to analyse the distribution of ‘non-elective’ births for each day of the week. Main outcome measures: The daily number of ‘non-elective’ births. Results: The number of ‘non-elective’ births varies considerably over the days of the week and over the year for each obstetric clinic regardless of clinic size. However, for each fixed day of the week, the variation over the year is well described by a Poisson distribution, allowing simple prediction of the variability. For births at each fixed day of the week, the Poisson distribution is indistinguishable from a normal distribution. Conclusions: The number of ‘non-elective’ births for each day of the week is well described by a Poisson distribution. Consequently, the Poisson model is suitable for estimating the variation in the daily number of ‘non-elective’ births and could be used for planning of staffing in obstetric clinics. The model can be used in smaller as well as larger clinics.

Objective To assess the clinical status of chronic spontaneous urticaria (CSU) and understand treatment approaches in Italy through specialists who treat CSU (dermatologists and allergy specialists) and CSU patients' experience. Design Multicentre survey. Setting Online structured questionnaires (one for physicians and one for patients). Participants Physicians and patients with CSU in Italy. Interventions None. Primary/secondary outcomes Physician and patient attitudes/experiences. Results Survey results from 160 allergy and 160 dermatology specialists show that specialists see a median of 40 (IQR 20–80) patients with CSU/year. While most specialists (56%) know the CSU guidelines, only 27% use them regularly (36% of allergy specialists vs 18% of dermatologists). This is reflected in treatment choices with differences between physicians who use guidelines regularly and those who do not: 91.6% vs 71.7% choose standard-dose, non-sedating antihistamines as first-line treatment; 85.9% vs 56.0% select up-dosing for second-line treatment and 65.3% vs 37.2% add leukotriene receptor antagonists or H2-antihistamines as third-line treatment. The diaries from 1385 patients highlight that, regardless of treatment regimen, 29.4% of currently treated patients are refractory to therapy. Specialists aim to resolve symptoms and only 7.8% report improving quality of life (QoL) as a priority. Only 16.6% of specialists are familiar with and use the Urticaria Activity Score while 46.9% do not know it. Overall, 537 patients with CSU were surveyed (median age 37 years, IQR 30–46; 44.3% men; median disease duration 5 years, IQR 3–20). Approximately 62% confirm that CSU negatively impacts their QoL. Patients also complain of difficulties in getting information and support

Background Second victims are healthcare workers who experience emotional distress following patient adverse events. Studies indicate the need to develop organisational support programmes for these workers. The RISE (Resilience In Stressful Events) programme was developed at the Johns Hopkins Hospital to provide this support. Objective To describe the development of RISE and evaluate its initial feasibility and subsequent implementation. Programme phases included (1) developing the RISE programme, (2) recruiting and training peer responders, (3) pilot launch in the Department of Paediatrics and (4) hospital-wide implementation. Methods Mixed-methods study, including frequency counts of encounters, staff surveys and evaluations by RISE peer responders. Descriptive statistics were used to summarise demographic characteristics and proportions of responses to categorical, Likert and ordinal scales. Qualitative analysis and coding were used to analyse open-ended responses from questionnaires and focus groups. Results A baseline staff survey found that most staff had experienced an unanticipated adverse event, and most would prefer peer support. A total of 119 calls, involving ∼500 individuals, were received in the first 52 months. The majority of calls were from nurses, and very few were related to medical errors (4%). Peer responders reported that the encounters were successful in 88% of cases and 83.3% reported meeting the caller9s needs. Low awareness of the programme was a barrier to hospital-wide expansion. However, over the 4 years, the rate of calls increased from ∼1–4 calls per month. The programme evolved to accommodate requests for group support. Conclusions Hospital staff identified the need for a multidisciplinary peer support programme for second victims. Peer responders reported success in responding to calls, the majority of which were for adverse events rather than for medical errors. The low initial volume of calls emphasises the importance of promoting awareness of the value of emotional support and the availability of the programme.