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In England and Wales, the Mental Health Act (MHA) 1983 provides the legal framework for the detention of individuals suffering from a mental disorder if they are judged to present a risk of harm to self or others. The MHA removes from certain psychiatric patients civil liberties otherwise inherent in our legal system. Through both statute and common law, it balances a patient’s right to autonomy with psychiatrists' duty of care by reference to the health and safety of the patient. It also balances the civil rights of individual patients against the right of society to protection.1 The 2018 Independent Review of the Mental Health Act (1983) set out recommendations for the government on how the MHA and associated practice needed to change in its final report ‘Modernising the Mental Health Act’.2 This led to the development of the government’s plans to reform the Act, together with the associated policy and practice, as set out in the white paper.3 The proposals take forward the recommendations made by the Independent Review and the full government response. The government is now consulting on its proposals before bringing forward a bill to amend the act. This commentary highlights the white paper’s marginalisation of patients detained under part III of the MHA. As a member of the Independent Review’s Department of Health and Social Care Topic Groups tasked with formulating recommendations for revision of the detention criteria and part III of the MHA, I am delighted that so many of our recommendations have been approved or are being given serious consideration by the government. However, I have substantial concerns about the white paper’s differential approach to civil (part II) and forensic (part III) patients, specifically the exclusion of forensic patients from the proposed changes to the detention criteria in the MHA. …

At the beginning of October, the member organisations of the European Association of Hospital Pharmacists (EAHP) adopted a new position paper on pharmacy preparations and compounding. The position aims at providing information about the practice of pharmacy preparations and compounding in hospitals and asks for a stronger embedment of compounding and reconstitution practices in European hospital pharmacies, linked to increasing capacity and training. The different sections of EAHP’s position paper touch on the importance of compounding for addressing patient needs, the involvement of hospital pharmacies in reconstitution practices and the role of hospital pharmacists in the preparation and use of advanced therapy medicinal products (ATMPs). Linked to personalised medication, it shares information on the engagement of hospital pharmacists and the adjustments …

IntroductionONCO-TreC platform consists of a mobile application delivered to patients as electronic diary and a web-based dashboard managed by healthcare professionals. We aim to compare the effectiveness of ONCO-TreC electronic diary with a standard paper diary, in improving adherence to oral cancer therapy in patients with solid and haematological tumours.Methods and analysisThis is an open label, superiority, randomised controlled trial conducted in two Italian oncology units. Patients will be randomised with a 1:1 ratio to electronic or paper diary. For both groups a counsellor will be responsible for drug and diary delivery. The evaluation period will end after six cycles of therapy. The primary aim is to compare the proportion of non-adherent patients in the two arms. Adherence will be measured through pill count; anyone who takes less than 90% of the total prescribed drug dose will be considered non-adherent. Assuming a percentage of non-adherent patients to oral therapy of 40% in arm B, and a 60% reduction in this percentage in arm A, a sample of 124 patients will provide 80% power to identify an absolute difference greater than 24 percentage points using a bilateral Fisher’s exact test with a significance level of 0.05. Considering a dropout rate of 10%, approximately 136 patients will have to be enrolled. The primary analysis will be performed on the intention-to-treat population. Secondary aims are to describe the reasons for non-adherence, the level of satisfaction of patients and healthcare professionals with the paper and electronic diary, and the impact of non-adherence in terms of healthcare costs.Ethics and disseminationEthical approval was obtained from Romagna Ethics Committee (CEROM), study ID 2108, prot. n. IRST 100.28 of 10/04/2020. Informed consent will be obtained from all study participants. Findings will be disseminated through peer-reviewed journals, conferences and event presentations.Protocol versionVersion 2, 6 April 2021.Trial registration numberNCT04826458.

Patient safety and quality of care are a priority for hospital pharmacists all across Europe. The European Association of Hospital Pharmacists (EAHP) has manifested the importance of patient safety for hospital pharmacy practice in a dedicated section of its European Statements of Hospital Pharmacy.1 As stewards of patients’ medication safety, hospital pharmacists are the key stakeholders ensuring the safe, effective and rational use of medicines by upholding the ‘rights’ of patients. This includes improving the safety of using medications, especially high-risk medication and look-alike and sound-alike (LASA) medications, through their close surveillance as well as advising on the most appropriate use of medicines. While some prescribing, dispensing and administration may not cause harm, it may not be cost-effective or beneficial for the patient. The abovementioned phrase 'appropriate use' encompasses a multitude of situations. Patient safety, which lies at the heart of all representations made by EAHP and its members, covers many aspects. EAHP’s position on patient safety specifically focuses on medication safety. In particular, medication errors, which occur when a medicine has been inappropriately prescribed, prepared, dispensed or administered to a patient, are a key concern for hospital pharmacists. Throughout the medication use process specific measures must be taken by healthcare professionals (figure 1). For hospital pharmacists these include improving medication safety by reducing available harm through using risk assessment procedures. Figure 1 The medication use process from a patient perspective. Even before a patient is treated for a specific disease, hospital pharmacists ensure the safety of the patient throughout the care pathway. These include actions linked to the hospital formulary, such as selecting narrow-spectrum antibiotics to prevent resistance, and implementation of the decision of the Drug and Therapeutics Committee, the proper selection and procurement as well as the application of appropriate quality assurance strategies for the medication use processes to …

Misuse of statistics in medical and sports science research is common and may lead to detrimental consequences to healthcare. Many authors, editors and peer reviewers of medical papers will not have expert knowledge of statistics or may be unconvinced about the importance of applying correct statistics in medical research. Although there are guidelines on reporting statistics in medical papers, a checklist on the more general and commonly seen aspects of statistics to assess when peer-reviewing an article is needed. In this article, we propose a CHecklist for statistical Assessment of Medical Papers (CHAMP) comprising 30 items related to the design and conduct, data analysis, reporting and presentation, and interpretation of a research paper. While CHAMP is primarily aimed at editors and peer reviewers during the statistical assessment of a medical paper, we believe it will serve as a useful reference to improve authors’ and readers’ practice in their use of statistics in medical research. We strongly encourage editors and peer reviewers to consult CHAMP when assessing manuscripts for potential publication. Authors also may apply CHAMP to ensure the validity of their statistical approach and reporting of medical research, and readers may consider using CHAMP to enhance their statistical assessment of a paper.

Misuse of statistics in medical and sports science research is common and may lead to detrimental consequences to healthcare. Many authors, editors and peer reviewers of medical papers will not have expert knowledge of statistics or may be unconvinced about the importance of applying correct statistics in medical research. Although there are guidelines on reporting statistics in medical papers, a checklist on the more general and commonly seen aspects of statistics to assess when peer-reviewing an article is needed. In this article, we propose a CHecklist for statistical Assessment of Medical Papers (CHAMP) comprising 30 items related to the design and conduct, data analysis, reporting and presentation, and interpretation of a research paper. While CHAMP is primarily aimed at editors and peer reviewers during the statistical assessment of a medical paper, we believe it will serve as a useful reference to improve authors’ and readers’ practice in their use of statistics in medical research. We strongly encourage editors and peer reviewers to consult CHAMP when assessing manuscripts for potential publication. Authors also may apply CHAMP to ensure the validity of their statistical approach and reporting of medical research, and readers may consider using CHAMP to enhance their statistical assessment of a paper.

In this White Paper, we discuss the current state of microbial cancer therapy. This paper resulted from a meeting (‘Microbial Based Cancer Therapy’) at the US National Cancer Institute in the summer of 2017. Here, we define ‘Microbial Therapy’ to include both oncolytic viral therapy and bacterial anticancer therapy. Both of these fields exploit tumor-specific infectious microbes to treat cancer, have similar mechanisms of action, and are facing similar challenges to commercialization. We designed this paper to nucleate this growing field of microbial therapeutics and increase interactions between researchers in it and related fields. The authors of this paper include many primary researchers in this field. In this paper, we discuss the potential, status and opportunities for microbial therapy as well as strategies attempted to date and important questions that need to be addressed. The main areas that we think will have the greatest impact are immune stimulation, control of efficacy, control of delivery, and safety. There is much excitement about the potential of this field to treat currently intractable cancer. Much of the potential exists because these therapies utilize unique mechanisms of action, difficult to achieve with other biological or small molecule drugs. By better understanding and controlling these mechanisms, we will create new therapies that will become integral components of cancer care.

BackgroundPrehospital delay contributes to treatment delay in acute stroke. Numerous prehospital stroke scales exist for stroke identification, but they lack the diagnostic accuracy of the in-hospital National Institutes of Health Stroke Scale (NIHSS). We have developed a mobile application to aid paramedics assessing prehospital NIHSS. This study explores agreement between NIHSS scores obtained using the Paramedic Norwegian Acute Stroke Prehospital Project (ParaNASPP) application compared with conventional assessment.Methods25 physicians working with stroke were randomised to an application group or control. 20 unique videos portraying acute stroke symptoms were scored by both groups. 95% limits of agreement (LoA) were calculated using Bland-Altman’s method, comparing the groups to predefined scores, and each other. LoAs within ±3 NIHSS points were considered acceptable. Cohen’s kappa was calculated on dichotomised NIHSS scores.ResultsThe ParaNASPP application group had 95% LoA of −2.33 to 2.71. The control group had LoA of −2.60 to 2.55. Direct comparison between the groups gave LoA of −3.12 to 3.55. When compared with the dichotomised predefined scores kappa was 0.93 in the application group and 0.89 in the control group. Kappa was 0.84 for direct comparison between the groups.DiscussionThere was very good agreement between the application and both the predefined score and the control group. Scores from the ParaNASPP application differ slightly more than our predefined goal when compared with the control group, but is well within when compared with the predefined NIHSS scores. We consider this acceptable and the ParaNASPP application validated for further clinical studies.

As the use of simulation has become more established in the delivery of healthcare education and training, there has been a corresponding increase in healthcare simulation research. Simulation-based research can be divided into research about simulation (answers research questions in which the focus is on simulation itself) and research through simulation (simulation as a method/tool for research). However, there are barriers, particularly for smaller less well-resourced simulation centres, that may prohibit participation in research. Therefore, it is suggested that quality improvement (QI) through simulation may be a pragmatic way in which simulation centres of all sizes can contribute to improving patient care beyond education and training. QI is defined as systematic, data-guided activities designed to bring about immediate, positive changes in the delivery of healthcare. Although not the case in healthcare, other industries routinely used simulation to support QI. For example, in aviation simulation is used to inform the design of the working environment, the appropriate use of technology, to exercise emergency procedures and to ‘re-fly’ flights following an adverse event as part of the mishap investigation. Integrating simulation within healthcare QI can support the development of novel interventions as well helping to address heretofore intractable issues.

IntroductionFront-line health workers in remote health facilities are the first contact of the formal health sector and are confronted with life-saving decisions. Health information systems (HIS) support the collection and use of health related data. However, HIS focus on reporting and are unfit to support decisions. Since data tools are paper-based in most primary healthcare settings, we have produced an innovative Paper-based Health Information System in Comprehensive Care (PHISICC) using a human-centred design approach. We are carrying out a cluster randomised controlled trial in three African countries to assess the effects of PHISICC compared with the current systems.Methods and analysisStudy areas are in rural zones of Côte d’Ivoire, Mozambique and Nigeria. Seventy health facilities in each country have been randomly allocated to using PHISICC tools or to continuing to use the regular HIS tools. We have randomly selected households in the catchment areas of each health facility to collect outcomes’ data (household surveys have been carried out in two of the three countries and the end-line data collection is planned for mid-2021). Primary outcomes include data quality and use, coverage of health services and health workers satisfaction; secondary outcomes are additional data quality and use parameters, childhood mortality and additional health workers and clients experience with the system. Just prior to the implementation of the trial, we had to relocate the study site in Mozambique due to unforeseen logistical issues. The effects of the intervention will be estimated using regression models and accounting for clustering using random effects.Ethics and disseminationEthics committees in Côte d’Ivoire, Mozambique and Nigeria approved the trials. We plan to disseminate our findings, data and research materials among researchers and policy-makers. We aim at having our findings included in systematic reviews on health systems interventions and future guidance development on HIS.Trial registration numberPACTR201904664660639; Pre-results.

IntroductionAs part of an investment by the Bill & Melinda Gates Foundation to support the Government of Bihar to improve reproductive, maternal, newborn and child health and nutrition (RMNCHN) statewide, BBC Media Action implemented multiple communication tools to support front-line worker (FLW) outreach. We analyse the impacts of a package of mHealth audio messaging and paper-based job aids used by FLWs during government-sponsored village health, sanitation and nutrition days (VHSNDs) on knowledge and practices of childbearing women across the RMNCHN continuum of care.MethodsData from two surveys collected between July and September 2016 were analysed using logistic regression to compare health-related knowledge and behaviours between women who had been exposed at VHSNDs to the mHealth GupShup Potli (GSP) audio recordings or interpersonal communication (IPC) tools versus those who were unexposed.ResultsExposure to GSP recordings (n=2608) was associated with improved knowledge across all continuum-of-care domains, as well as improved health-related behaviours in some domains. The odds of having taken iron-folic acid (IFA) tablets were significantly higher in exposed women (OR 1.5, 95% CI 1.1 to 2.2), as was contraceptive use (OR 2.0, 95% CI 1.2 to 3.2). There were no differences in birth preparedness or complementary feeding practices between groups. Exposure to IPC paper-based tools (n=2002) was associated with a twofold increased odds of IFA consumption (OR 2.3, 95% CI 1.7 to 3.2) and contraceptive use (OR 1.8, 95% CI 1.2 to 2.8). Women exposed to both tools were generally at least twice as likely to subsequently discuss the messages with others.ConclusionBBC Media Action’s mHealth audio messaging job aids and paper-based IPC tools were associated with improved knowledge and practices of women who were exposed to them across multiple domains, suggesting their important potential for improving health outcomes for beneficiaries at scale in low-resource settings.Trial registration numberNCT02726230.

IntroductionChronic breathlessness is a common and debilitating symptom, associated with high healthcare use and reduced quality of life. Challenges and delays in diagnosis for people with chronic breathlessness frequently occur, leading to delayed access to therapies. The overarching hypothesis is a symptom-based approach to diagnosis in primary care would lead to earlier diagnosis, and therefore earlier treatment and improved longer-term outcomes including health-related quality of life. This study aims to establish the feasibility of a multicentre cluster randomised controlled trial to assess the clinical and cost-effectiveness of a structured diagnostic pathway for breathlessness in primary care.Methods and analysisTen general practitioner (GP) practices across Leicester and Leicestershire will be cluster randomised to either a structured diagnostic pathway (intervention) or usual care. The structured diagnostic pathway includes a panel of investigations within 1 month. Usual care will proceed with patient care as per normal practice. Eligibility criteria include patients presenting with chronic breathlessness for the first time, who are over 40 years old and without a pre-existing diagnosis for their symptoms. An electronic template triggered at the point of consultation with the GP will aid opportunistic recruitment in primary care. The primary outcome for this feasibility study is recruitment rate. Secondary outcome measures, including time to diagnosis, will be collected to help inform outcomes for the future trial and to assess the impact of an earlier diagnosis. These will include symptoms, health-related quality of life, exercise capacity, measures of frailty, physical activity and healthcare utilisation. The study will include nested qualitative interviews with patients and healthcare staff to understand the feasibility outcomes, explore what is ‘usual care’ and the study experience.Ethics and disseminationThe Research Ethics Committee Nottingham 1 has provided ethical approval for this research study (REC Reference: 19/EM/0201). Results from the study will be disseminated by presentations at relevant meetings and conferences including British Thoracic Society and Primary Care Respiratory Society, as well as by peer-reviewed publications and through patient presentations and newsletters to patients, where available.Trial registration numberISRCTN14483247.

IntroductionAutism spectrum conditions (ASC) develop early in life and are thought to last a lifetime. However, ASC research has two major knowledge gaps that hinder progression in understanding the concept of ASC and in providing proper support for autistic adults: (1) the majority of knowledge about ASC mainly stems from childhood studies so little is known about older autistic adults and (2) while it is broadly recognised that ASC is a heterogeneous condition, we do not yet understand the differences in trajectories leading to their future outcome. We aim to fill both knowledge gaps.Methods and analysisA multistage overlapping cohort design assessing (cognitive) ageing in ASC is designed to obtain an accelerated longitudinal data set. Data, including a multitude of questionnaires, diagnostics and cognitive tests, are collected over four waves within a 10-year time frame. This will provide information regarding actual changes in quality of life, co-occurring health conditions and cognition as well as the possibility to test external validity and temporal stability in newly formed behavioural subtypes. Participants consist of three groups of adults aged 20–90 years: (1) with a clinical diagnosis of ASC, (2) with a clinical diagnosis of attention deficit hyperactivity disorder (ADHD) but no ASC, (3) no ASC/ADHD (ie, comparison group). The sample size differs between waves and instruments. Detailed analysis plans will be preregistered in AsPredicted or at the Open Science Framework.Ethics and disseminationEthical approval for this study was obtained from the ethical review board of the Department of Psychology of the University of Amsterdam (wave 1 2011-PN-1952 and 2013-PN-2668, wave 2 2015-BC-4270, waves 3 and 4 2018-BC-9285). In line with the funding policies of the grant organisation funding this study, future papers will be published open access.

Each year, the Heart editorial team selects the most meritorious research paper to receive the Heart Best Research Paper Award. Primary considerations are the relevance of the clinical question addressed by the research, the quality of the research study design and data presentation and the interest generated by the paper among other researchers, clinical cardiologists and the general public. This year, we are pleased to announce the winner and two finalists for the 2021 Heart Best Paper Research Award, highlighting the first author of each paper and sincerely congratulating the entire research team on their outstanding research contribution (table 1). Each of the authors contributed the text below summarising their background, research goals and the key findings of these studies. View this table: Table 1 Heart Best Research Paper Award winner and finalists 2020 Julia Hippisley-Cox (figure 1) is Professor of Clinical Epidemiology and General Practice at the University of Oxford and an NHS GP in Oxfordshire. She undertakes research to advance understanding of many diseases using routinely collected large-scale linked electronic health records. She is particularly interested in translational research where the results can lead to improvements in patient care and the health services. …

Introduction: Managing chronic musculoskeletal problems usually focuses on pain control using medications, but outcomes are often unsatisfactory and sometimes harmful. Information on a patient’s health-related quality of life (HRQOL) may trigger a doctor to tailor management improving quality of life. The aim of this trial is to find out whether routine measurement and reporting of a patient’s EuroQoL 5-Dimension 5-Level (EQ-5D-5L) HRQOL data using an electronic platform can improve HRQOL and pain in patients with chronic knee or back problems in primary care. We will also assess the acceptability of routine electronic measurements and reporting of the EQ-5D-5L in primary care settings. Methods: This is a multicentre, prospective, cluster randomised controlled trial set in six public primary care clinics in Hong Kong. At the intervention clinics, subjects will complete an electronic EQ-5D-5L form at recruitment and at each clinic follow-up over 12 months. A report of the patient’s longitudinal EQ-5D-5L data will be provided to the doctor. Subjects in the control clinics will receive care as usual. All subjects will complete the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a 10-point Pain Rating Scale and a structured questionnaire to collect sociodemographic information and data on morbidity and service utilisation at recruitment at baseline, 3, 6 and 12 months. Primary outcome is the change in WOMAC total score. Secondary outcomes are change in pain, other patient-reported outcome scores and doctor-rated severity of disease. Group differences in the changes in WOMAC and other outcome scores over time will be analysed using generalised estimating equation model with an intention-to-treat principle. Ethics and dissemination: Ethics approval has been obtained from The University of Hong Kong/Hospital Authority Hong Kong West Cluster (IRB reference number: UW 18-270). The results of the trial will be submitted for publication in a peer-reviewed journal. Trial registration number: NCT03609762.

IntroductionCompared with the rest of the UK and Western Europe, England has high rates of the infectious disease tuberculosis (TB). TB is curable, although treatment is for at least 6 months and longer when disease is drug resistant. If patients miss too many doses (non-adherence), they may transmit infection for longer and the infecting bacteria may develop resistance to the standard drugs used for treatment. Non-adherence may therefore risk both their health and that of others. Within England, certain population groups are thought to be at higher risk of non-adherence, but the factors contributing to this have been insufficiently determined, as have the best interventions to promote adherence. The objective of this study was to develop a manualised package of interventions for use as part of routine care within National Health Services to address the social and cultural factors that lead to poor adherence to treatment for TB disease.Methods and analysisThis study uses a mixed-methods approach, with six study components. These are (1) scoping reviews of the literature; (2) qualitative research with patients, carers and healthcare professionals; (3) development of the intervention; (4) a pilot randomised controlled trial of the manualised intervention; (5) a process evaluation to examine clinical utility; and (6) a cost analysis.Ethics and disseminationThis study received ethics approval on 24 December 2018 from Camberwell St. Giles Ethics Committee, UK (REC reference 18/LO/1818). Findings will be published and disseminated through peer-reviewed publications and conference presentations, published in an end of study report to our funder (the National Institute for Health Research, UK) and presented to key stakeholders.Trial registration numberNCT95243114Secondary identifying numbersUniversity College London/University College London Hospitals Joint Research Office 17/0726.National Institute for Health Research, UK 16/88/06.

Objective Analyses of the impact of a body of clinical trial reports subject to research misconduct have been few. Our objective was to examine the impact on clinically relevant research of a group of researchers’ trial reports (‘affected trial reports’) affected by research misconduct, and whether identification of misconduct invoked a reappraisal. Design In 2016, we used five databases and search engines to identify ‘citing publications’, that is, guidelines, systematic and other reviews, and clinical trials citing any of 12 affected trial reports, published 1998–2011, eventually retracted for research misconduct. The affected trial reports were assessed more likely to have had impact because they had hip fracture outcomes and were in journals with impact factor >4. Two authors assessed whether findings of the citing publications would change if the affected trial reports were removed. In 2018, we searched for evidence that the citing publications had undertaken a reassessment as a result of the potential influence of the affected trial reports. Results By 2016 the affected trial reports were cited in 1158 publications, including 68 systematic reviews, meta-analyses, narrative reviews, guidelines and clinical trials. We judged that 13 guidelines, systematic or other reviews would likely change their findings if the affected trial reports were removed, and in another eight it was unclear if findings would change. By 2018, only one of the 68 citing publications, a systematic review, appeared to have undertaken a reassessment, which led to a correction. Conclusions We found evidence that this group of affected trial reports distorted the evidence base. Correction of these distortions is slow, uncoordinated and inconsistent. Unless there is a rapid, systematic, coordinated approach by bibliographic databases, authors, journals and publishers to mitigate the impact of known cases of research misconduct, patients, other researchers and their funders may continue to be adversely affected.

When a patient presents with tremor, it can be useful to perform a few simple pen and paper tests. In this article, we explain how to maximise the value of handwriting and of drawing Archimedes spirals and straight lines as clinical assessments. These tasks take a matter of seconds to complete but provide a wealth of information that supplements the standard physical examination. They aid the diagnosis of a tremor disorder and can contribute to its longitudinal monitoring. Watching the patient’s upper limb while they write and draw may reveal abnormalities such as bradykinesia, dystonic posturing and distractibility. The finished script and drawings can then be evaluated for frequency, amplitude, direction and symmetry of oscillatory pen movements and for overall scale of penmanship. Essential, dystonic, functional and parkinsonian tremor each has a characteristic pattern of abnormality on these pen and paper tests.

IntroductionChronic kidney disease (CKD) management in the UK is usually primary care based, with National Institute for Health and Care Excellence (NICE) guidelines defining criteria for referral to secondary care nephrology services. Estimated glomerular filtration rate (eGFR) is commonly used to guide timing of referrals and preparation of patients approaching renal replacement therapy. However, eGFR lacks sensitivity for progression to end-stage renal failure; as a consequence, the international guideline group, Kidney Disease: Improving Global Outcomes has recommended the use of a risk calculator. The validated Kidney Failure Risk Equation may enable increased precision for the management of patients with CKD; however, there is little evidence to date for the implication of its use in routine clinical practice. This study will aim to determine the impact of the Kidney Failure Risk Equation on the redesignation of patients with CKD in the UK for referral to secondary care, compared with NICE CKD guidance.Method and analysisThis is a cross-sectional population-based observational study using The Health Improvement Network database to identify the impact of risk-based designation for referral into secondary care for patients with CKD in the UK. Adult patients registered in primary care and active in the database within the period 1 January 2016 to 31 March 2017 with confirmed CKD will be analysed. The proportion of patients who meet defined risk thresholds will be cross-referenced with the current NICE guideline recommendations for referral into secondary care along with an evaluation of urinary albumin–creatinine ratio monitoring.Ethics and disseminationApproval was granted by The Health Improvement Network Scientific Review Committee (Reference number: 18THIN061). Study outcomes will inform national and international guidelines including the next version of the NICE CKD guideline. Dissemination of findings will also be through publication in a peer-reviewed journal, presentation at conferences and inclusion in the core resources of the Think Kidneys programme.

Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology is used to assess and report certainty of evidence and strength of recommendations. This GRADE concept article is not GRADE guidance but introduces certainty of net benefit, defined as the certainty that the balance between desirable and undesirable health effects is favourable. Determining certainty of net benefit requires considering certainty of effect estimates, the expected importance of outcomes and variability in importance, and the interaction of these concepts. Certainty of net harm is the certainty that the net effect is unfavourable. Guideline panels using or testing this approach might limit strong recommendations to actions with a high certainty of net benefit or against actions with a moderate or high certainty of net harm. Recommendations may differ in direction or strength from that suggested by the certainty of net benefit or harm when influenced by cost, equity, acceptability or feasibility.

IntroductionThe occurrence of thyroid cancer is increasing throughout the developed world and since the 1990s has become the fastest increasing malignancy. In 2014, a total of 2693 Australians and 302 New Zealanders were diagnosed with thyroid cancer, with this number projected to rise to 3650 in 2018. The purpose of this protocol is to establish a binational population-based clinical quality registry with the aim of monitoring and improving the quality of care provided to patients diagnosed with thyroid cancer in Australia and New Zealand.Methods and analysisThe Australian and New Zealand Thyroid Cancer Registry (ANZTCR) aims to capture clinical data for all patients over the age of 16 years with thyroid cancer, confirmed by histopathology report, who have been diagnosed, assessed or treated at a contributing hospital. A multidisciplinary steering committee was formed which, with operational support from Monash University, established the ANZTCR in early 2017. The pilot phase of the registry is currently operating in Victoria, New South Wales, Queensland, Western Australia and South Australia, with over 20 sites expected to come on board across Australia in 2018. A modified Delphi process was undertaken to determine the clinical quality indicators to be reported by the registry, and a minimum data set was developed comprising information regarding thyroid cancer diagnosis, pathology, surgery and 90-day follow-up.Future plansThe establishment of the ANZTCR provides the opportunity for Australia and New Zealand to further understand current practice in the treatment of thyroid cancer and identify variation in outcomes. The engagement of endocrine surgeons in supporting this initiative is crucial. While the pilot registry has a focus on early clinical outcomes, it is anticipated that future collection of longer term outcome data particularly for patients with poor prognostic disease will add significant further value to the registry.

IntroductionMany patients now turn to the internet as a resource for healthcare information and advice. However, patients’ use of the internet to manage their health has been positioned as a potential source of strain on the doctor–patient relationship in primary care. The current evidence about what happens when internet-derived health information is introduced during consultations has relied on qualitative data derived from interview or questionnaire studies. The ‘Harnessing resources from the internet to maximise outcomes from GP consultations (HaRI)’ study combines questionnaire, interview and video-recorded consultation data to address this issue more fully.Methods and analysisThree data collection methods are employed: preconsultation patient questionnaires, video-recorded consultations between general practitioners (GP) and patients, and semistructured interviews with GPs and patients. We seek to recruit 10 GPs practising in Southeast England. We aim to collect up to 30 patient questionnaires and video-recorded consultations per GP, yielding up to 300. Up to 30 patients (approximately three per participating GP) will be selected for interviews sampled for a wide range of sociodemographic characteristics, and a variety of ways the use of, or information from, the internet was present or absent during their consultation. We will interview all 10 participating GPs about their views of online health information, reflecting on their own usage of online information during consultations and their patients’ references to online health information. Descriptive, conversation and thematic analysis will be used respectively for the patient questionnaires, video-recorded consultations and interviews.Ethics and disseminationEthical approval has been granted by the London–Camden & Kings Cross Research Ethics Committee. Alongside journal publications, dissemination activities include the creation of a toolkit to be shared with patients and doctors, to guide discussions of material from the internet in consultations.

Reviewing the landscape of Emergency Medicine (EM) publication and research over the past 50 years is an immensely rewarding exercise and emphasises with absolute clarity how far we have come as a specialty in such a relatively short time. The key words which apply to the review are prescient and resonant. The pioneering research undertaken in the earlier years of the specialty represents the very bedrock on which stands Emergency Medicine as we know it today. This paper will highlight some of the key publications during the 50 years of Emergency Medicine in the UK.

In this article we signpost readers to 10 papers we consider essential reading for anyone starting out on an evidence-based medicine journey. We have considered papers consisting a mix of old and new, seminal and cutting-edge that offer insight into what evidence-based medicine is, where it came from, why it matters and what it has achieved. This is balanced against some of the common criticisms of evidence-based medicine and efforts to tackle them. We have also highlighted papers acknowledging the importance of teaching and learning of the principles of evidence-based medicine and how health professionals can better use evidence in clinical decisions with patients.

Background Healthcare professionals develop workarounds rather than using electronic health record (EHR) systems. Understanding the reasons for workarounds is important to facilitate user-centered design and alignment between work context and available health information technology tools. Objective To examine both paper- and computerbased workarounds to the use of EHR systems in three benchmark institutions. Methods Qualitative data were collected in 11 primary care outpatient clinics across three healthcare institutions. Data collection methods included direct observation and opportunistic questions. In total, 120 clinic staff and providers and 118 patients were observed. All data were analyzed using previously developed workaround categories and examined for potential new categories. Additionally, workarounds were coded as either paper- or computer-based. Results Findings corresponded to 10 of 11 workaround categories identified in previous research. All 10 of these categories applied to paper-based workarounds; five categories also applied to computerbased workarounds. One new category, no correct path (eg, a desired option did not exist in the computer interface, precipitating a workaround), was identified for computer-based workarounds. The most consistent reasons for workarounds across the three institutions were efficiency, memory, and awareness. Conclusions Consistent workarounds across institutions suggest common challenges in outpatient clinical settings and failures to accommodate these challenges in EHR design. An examination of workarounds provides insight into how providers adapt to limiting EHR systems. Part of the design process for computer interfaces should include user-centered methods particular to providers and healthcare settings to ensure uptake and usability.

Introduction The overall aim of this project is to help develop knowledge about primary care delivery models likely to improve the accessibility, quality and efficiency of care. Operationally, this objective will be achieved through supporting and evaluating 8 primary care team pilot sites that rely on an expanded nursing role within a more intensive team-based, interdisciplinary setting. Methods and analysis The first research component is aimed at supporting the development and implementation of the pilot projects, and is divided into 2 parts. The first part is a logical analysis based on interpreting available scientific data to understand the causal processes by which the objectives of the intervention being studied may be achieved. The second part is a developmental evaluation to support teams in the field in a participatory manner and thereby learn from experience. Operationally, the developmental evaluation phase mainly involves semistructured interviews. The second component of the project design focuses on evaluating pilot project results and assessing their costs. This component is in turn made up of 2 parts. Part 1 is a pre-and-post survey of patients receiving the intervention care to analyse their care experience. In part 2, each patient enrolled in part 1 (around 4000 patients) will be matched with 2 patients followed within a traditional primary care model, so that a comparative analysis of the accessibility, quality and efficiency of the intervention can be performed. The cohorts formed in this way will be followed longitudinally for 4 years. Ethics and dissemination The project, as well as all consent forms and research tools, have been accepted by 2 health sciences research ethics committees. The procedures used will conform to best practices regarding the anonymity of patients.

Objectives Patients with complex long-term needs experience multiple parallel care processes, which may have conflicting or competing goals, within their individual patient trajectory (iPT). The alignment of multiple goals is often implicit or non-existent, and has received little attention in the literature. Research questions: (1) What goals for care relevant for the iPT can be identified from the literature? (2) What goal typology can be proposed based on goal characteristics? (3) How can professionals negotiate a consistent set of goals for the iPT? Design Document content analysis of health service research papers, on the topic of ‘goals for care’. Setting With the increasing prevalence of multimorbidity, guidance regarding the identification and alignment of goals for care across organisations and disciplines is urgently needed. Participants 70 papers that describe ‘goals for care’, ‘health’ or ‘the good healthcare process’ relevant to a general iPT, identified in a step-wise structured search of MEDLINE, Web of Science and Google Scholar. Results We developed a goal typology with four categories. Three categories are professionally defined: (1) Functional, (2) Biological/Disease and (3) Adaptive goals. The fourth category is the patient's personally defined goals. Professional and personal goals may conflict, in which case goal prioritisation by creation of a goal hierarchy can be useful. We argue that the patient has the moral and legal right to determine the goals at the top of such a goal hierarchy. Professionals can then translate personal goals into realistic professional goals such as standardised health outcomes linked to evidence-based guidelines. Thereby, when goals are aligned with one another, the iPT will be truly patient centred, while care follows professional guidelines. Conclusions Personal goals direct professional goals and define the success criteria of the iPT. However, making personal goals count requires brave and wide-sweeping attitudinal, organisational and regulatory transformation of care delivery. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

We present key points from the updated Dutch-Flemish guideline on comprehensive diagnostics in disorders/differences of sex development (DSD) that have not been widely addressed in the current (inter)national literature. These points are of interest to physicians working in DSD (expert) centres and to professionals who come across persons with a DSD but have no (or limited) experience in this area. The Dutch-Flemish guideline is based on internationally accepted principles. Recent initiatives striving for uniform high-quality care across Europe, and beyond, such as the completed COST action 1303 and the European Reference Network for rare endocrine conditions (EndoERN), have generated several excellent papers covering nearly all aspects of DSD. The Dutch-Flemish guideline follows these international consensus papers and covers a number of other topics relevant to daily practice. For instance, although next-generation sequencing (NGS)-based molecular diagnostics are becoming the gold standard for genetic evaluation, it can be difficult to prove variant causality or relate the genotype to the clinical presentation. Network formation and centralisation are essential to promote functional studies that assess the effects of genetic variants and to the correct histological assessment of gonadal material from DSD patients, as well as allowing for maximisation of expertise and possible cost reductions. The Dutch-Flemish guidelines uniquely address three aspects of DSD. First, we propose an algorithm for counselling and diagnostic evaluation when a DSD is suspected prenatally, a clinical situation that is becoming more common. Referral to ultrasound sonographers and obstetricians who are part of a DSD team is increasingly important here. Second, we pay special attention to healthcare professionals not working within a DSD centre as they are often the first to diagnose or suspect a DSD, but are not regularly exposed to DSDs and may have limited experience. Their thoughtful communication to patients, carers and colleagues, and the accessibility of protocols for first-line management and efficient referral are essential. Careful communication in the prenatal to neonatal period and the adolescent to adult transition are equally important and relatively under-reported in the literature. Third, we discuss the timing of (NGS-based) molecular diagnostics in the initial workup of new patients and in people with a diagnosis made solely on clinical grounds or those who had earlier genetic testing that is not compatible with current state-of-the-art diagnostics.

We present key points from the updated Dutch-Flemish guideline on comprehensive diagnostics in disorders/differences of sex development (DSD) that have not been widely addressed in the current (inter)national literature. These points are of interest to physicians working in DSD (expert) centres and to professionals who come across persons with a DSD but have no (or limited) experience in this area. The Dutch-Flemish guideline is based on internationally accepted principles. Recent initiatives striving for uniform high-quality care across Europe, and beyond, such as the completed COST action 1303 and the European Reference Network for rare endocrine conditions (EndoERN), have generated several excellent papers covering nearly all aspects of DSD. The Dutch-Flemish guideline follows these international consensus papers and covers a number of other topics relevant to daily practice. For instance, although next-generation sequencing (NGS)-based molecular diagnostics are becoming the gold standard for genetic evaluation, it can be difficult to prove variant causality or relate the genotype to the clinical presentation. Network formation and centralisation are essential to promote functional studies that assess the effects of genetic variants and to the correct histological assessment of gonadal material from DSD patients, as well as allowing for maximisation of expertise and possible cost reductions. The Dutch-Flemish guidelines uniquely address three aspects of DSD. First, we propose an algorithm for counselling and diagnostic evaluation when a DSD is suspected prenatally, a clinical situation that is becoming more common. Referral to ultrasound sonographers and obstetricians who are part of a DSD team is increasingly important here. Second, we pay special attention to healthcare professionals not working within a DSD centre as they are often the first to diagnose or suspect a DSD, but are not regularly exposed to DSDs and may have limited experience. Their thoughtful communication to patients, carers and colleagues, and the accessibility of protocols for first-line management and efficient referral are essential. Careful communication in the prenatal to neonatal period and the adolescent to adult transition are equally important and relatively under-reported in the literature. Third, we discuss the timing of (NGS-based) molecular diagnostics in the initial workup of new patients and in people with a diagnosis made solely on clinical grounds or those who had earlier genetic testing that is not compatible with current state-of-the-art diagnostics.

The white paper Choosing Health: making healthy choices easier lays out the government's approach to tackling a broad range of public health challenges from smoking, obesity, and drinking to mental and sexual health.1 Positive aspects, such as signposting foods to indicate their fat, salt, and sugar contents have quite rightly been welcomed. Limitations, including the ironic coupling of the emphasis on individual choice with a failure to tackle secondhand smoke, are being highlighted by the relevant expert groups. The public are developing an awareness of the relevance of these public health issues in their lives, thanks in part to the substantial media coverage of the report's contents and of stakeholders' responses. At least these problems are beginning to get a thorough public airing, which must be a step in the right direction for further policy change. However, to maximise the benefits of such a substantial switch towards prevention, as urged by Wanless,2 three fundamental blind spots need to be considered. The first exemplifies a historical failure to match rhetoric with action. The report promises to help local health services deal with inequalities: “We are giving primary care trusts the means to tackle health inequalities and improve health through funding to give greater priority to areas of high health need...” This implies recognition of the need to provide greater resources to those primary care trusts in most need in order to move disadvantaged people up to the level of advantaged people.3 However, the promise rings hollow for many primary care trusts serving deprived communities. The government has set inequalities targets for these primary care trusts requiring them to improve the health of their populations faster than the average for the United Kingdom.4 Many of these are already struggling because they have not even received the funding they are due according to the government's own calculations of their requirements.5 In northeast London, for example, all four of the primary care trusts defined as being in the government's “spearhead group” (which means they have the worst health and deprivation indices), are currently under-funded to a total of over £80m ($149m; €114m) against their weighted capitation target. The second blind spot is an inability to work through the consequences of worrying about being labelled as a nanny state. As a result, the recommendations on banning smoking are inconsistent and may actually increase health inequalities due to differential uptake by people across the socioeconomic divide.6 Encouraging smoking cessation on an individual level is one thing, but allowing smoking in pubs that do not serve prepared food undermines this effort. It is precisely people who visit pubs where food is not served who are in most need of protection from the effects of secondhand smoke. In this way the white paper fails to address the inequalities that purport to be the driving force behind it. The third blind spot is the government's reluctance to take its own medicine. That decisions should be informed by robust research evidence is becoming embedded across the health service, and the white paper does pay some attention to the need to use evidence based interventions. A pity then that such emphasis is placed on individualistic interventions such as the provision of educational materials, when it is well established that information alone does not entice people to change behaviour. Nor will the provision of fruit for your lunch box alter eating habits so long as healthy eating is perceived to be posh.7 That the government persists in believing that it is as simple as that is disappointing. Improving public health is about changing behaviour. We need an in-depth understanding of the personal values, beliefs, preferences, and aspirations that drive behaviours in different social groups. Only then can we begin to design interventions to modify deep seated cultural norms and to challenge ingrained ambivalence. Changing behaviour will require the implementation of comprehensive structural, environmental, and economic interventions. For example, the report has nothing about using the taxation system to increase the minimum weekly income for healthy living,8 or for increasing taxes on tobacco, which are known to have the greatest effects on smoking levels of young people.9 The white paper does signal a seminal moment in terms of attention to public health and could have a profound impact. But the government must consider its blind spots and show a commitment to tackle complex environmental and personal barriers to behaviour change if it is to fulfil its pledge to make healthy choices easier.

Introduction Inequalities are evident in early childhood caries rates with the socially disadvantaged experiencing greater burden of disease. This study builds on formative qualitative research, conducted in the Moreland/Hume local government areas of Melbourne, Victoria 2006–2009, in response to community concerns for oral health of children from refugee and migrant backgrounds. Development of the community-based intervention described here extends the partnership approach to cogeneration of contemporary evidence with continued and meaningful involvement of investigators, community, cultural and government partners. This trial aims to establish a model for child oral health promotion for culturally diverse communities in Australia. Methods and analysis This is an exploratory trial implementing a community-based child oral health promotion intervention for Australian families from refugee and migrant backgrounds. Families from an Iraqi, Lebanese or Pakistani background with children aged 1–4 years, residing in metropolitan Melbourne, were invited to participate in the trial by peer educators from their respective communities using snowball and purposive sampling techniques. Target sample size was 600. Moreland, a culturally diverse, inner-urban metropolitan area of Melbourne, was chosen as the intervention site. The intervention comprised peer educator led community oral health education sessions and reorienting of dental health and family services through cultural Competency Organisational Review (CORe). Ethics and dissemination Ethics approval for this trial was granted by the University of Melbourne Human Research Ethics Committee and the Department of Education and Early Childhood Development Research Committee. Study progress and output will be disseminated via periodic newsletters, peer-reviewed research papers, reports, community seminars and at National and International conferences. Trial registration number Australian New Zealand Clinical Trials Registry (ACTRN12611000532909).

Introduction Stroke is a major health problem and transient ischaemic attack (TIA) is an important risk factor for stroke. Primary prevention of stroke and TIA will have the greatest impact on reducing the burden of these conditions. Evidence-based guidelines for stroke/TIA prevention identify individuals eligible for preventative interventions in primary care. This study will investigate: (1) the proportion of strokes/TIAs with prior missed opportunities for prevention in primary care; (2) the influence of patient characteristics on missed prevention opportunities and (3) how the proportion of missed prevention opportunities has changed over time. Methods and analysis A retrospective case review will identify first-ever stroke and patients with TIA between 2000 and 2013 using anonymised electronic medical records extracted from the health improvement network (THIN) database. Four categories of missed opportunities for stroke/TIA prevention will be sought: untreated high blood pressure in patients eligible for treatment (either blood pressure ≥160/100 or ≥140/90 mm Hg in patients at high cardiovascular disease (CVD) risk); patients with atrial fibrillation with high stroke risk and no anticoagulant therapy; no lipid modifying drug therapy prescribed in patients at high CVD risk or with familial hypercholesterolaemia. The proportion of patients with each missed opportunity and multiple missed opportunities will be calculated. Mixed effect logistic regression will model the relationship between demographic and patient characteristics and missed opportunities for care; practice will be included as a random effect. Ethics and dissemination THIN data collection was approved by the NHS South East Multi-centre Research Ethics Committee (MREC) in 2003. This study was approved by the independent scientific review committee in May 2013. Dissemination of findings has the potential to change practice, improve the quality of care provided to patients and ultimately reduce the incidence of strokes and TIAs. Findings will be published in a peer-reviewed journal and disseminated at national and international conferences.

The emergence of SARS-CoV-2 in the end of 2019, an aetiologic agent responsible for the 1SARS plunged the world into an unprecedented sanitary crisis. Papers on COVID-19 have been fast-tracked since then.2–5 Accelerated time from submission to publication6–8 and qualitative changes in peer review,9 associated with empirical evidence that duplicate and implausible clinical trials have been carried out during the pandemic,10–12 could perhaps imply lower quality of peer review in COVID-19 research. Accumulating empirical evidence has also been indicating the pandemic era output to be less reliable than its prepandemic counterpart.2 10–14 A systematic review to evaluate the methodological quality of COVID-19 peer-reviewed clinical studies compared with historical controls found methodological quality scores to be lower in COVID-19 articles across all study designs.12 Meanwhile, data sharing practices remained largely unchanged during the first year of the pandemic.13 14 With no mandates of data sharing in place for COVID-19 studies, the reproducibility of these data on COVID-19 is yet to be independently verified as well.2 However, more efficiency in scientific publication did manifest in accelerated publication,6–8 journals tearing down their paywalls for their COVID-19 output,14 an increased usage of life and medical sciences preprint servers to increase speed and transparency,15 not to mention the intense international collaboration that resulted in the development of multiple high-efficacy vaccines within the first year of the pandemic.16 On the other hand, some pratices that reduce the reliability of clinical trials may have gained some traction during 2020, such as executing underpowered studies with small samples, multiplicity of trials testing ideas with low prior probability of being true, forgoing blinding to test interventions10 11 14 17–20 and incomplete reporting of findings, which was already an issue before the pandemic.12 21 To …

Making a difference in medication by delivering tailor-made medicines for the benefit of patients The patient-oriented preparation of medicines is anchored deeply in pharmacy practice. Since the establishment of the profession, hospital pharmacies have manufactured, prepared and compounded medicines to adequately respond to patient needs, especially for those individual patients or patient groups whose medical requirements cannot be met by industrially manufactured medicines.1 The term ‘compounding’2 is frequently used in the English speaking literature, while in continental Europe the term ‘pharmacy preparation’3 is mainly applied. This position paper regards both the term ‘pharmacy preparation’ and the term ‘compounding’ as interchangeable but will mainly refer to ‘compounding’. Another process related to preparation is ‘reconstitution’.4 This process is not necessarily confined to a pharmacy. Reconstitution entails, for example, adding a diluent to a powdered medication to prepare a solution or suspension. Due to the shift towards personalised medicines, including advanced therapy medicinal products (ATMPs), the strain on national healthcare budgets and medicines shortages, compounding has regained significance in Europe. The position paper of the European Association of Hospital Pharmacists (EAHP) aims at providing information about this practice in hospitals and asks for a stronger embedment of compounding and reconstitution practices in European hospital pharmacies, linked to increasing capacity and training. ### To further enhance patient care in Europe, EAHP

OBJECTIVES: To improve the disinfection methods for materials with a non-sterile surface to be used in aseptic handling.METHODS: The surface bioburden on ampoules (A) and injection vials (IV) is determined by contact plates and total immersion. The occurrence of spore-forming bacteria is determined by strain colouring and matrix-assisted laser desorption ionisation-time of flight mass spectrometry. The disinfection procedures of non-sterile materials in 10 hospital pharmacies are judged by observing.RESULTS: After wiping according to local disinfection methods, the mean surface bioburden determined by contact plates in 10 hospital pharmacies is 0.36 (plastic A), 0.50 (glass A) and 0.29 colony-forming unit (cfu) (IV). The observers found great differences in accuracy of wiping and degree of wetting the sterile gauzes.After improved wiping with commercially available alcohol impregnated sterile wipes and a two-towel technique (one-step TT disinfection), the mean surface bioburden determined by contact plates is 0.03 (plastic A), 0.2 (glass A) and 0.13 cfu (IV). Further improvement can be reached by submerging A and IV in ethanol 70% followed by improved wiping (two-step TT disinfection), but still micro-organisms will remain (mean surface bioburden determined by total immersion is 0 (plastic A) and 0.3 cfu (IV); glass A not determined). Two-step TT disinfection is more labour intensive. Spilling of alcohol is another disadvantage. However, we presume one-step TT disinfection is effective enough in daily practice. Routine surface bioburden determinations have to prove this.The effectiveness of the combination of spray and wipe is not examined because we observed a quick disappearance of alcohols from vertical as well as horizontal surfaces, which shortens the contact time to far below the advised 2 min.Spore-forming bacteria disappear as quickly as other micro-organisms during disinfection by alcohols.CONCLUSION: Local disinfection procedures can be improved. Complete removal of micro-organisms from materials with a non-sterile surface, even after two-step TT disinfection, is impossible. Routine surface bioburden determinations have to prove if one-step TT disinfection is effective enough.

The results of the Prevention Of Pelvic Infection (POPI) trial,1 published soon after criticism about the value for money of the chlamydia screening programme in England,2 should make us think even harder about how to investigate and control chlamydia and its associated morbidity. Should we be doing more of the same, but better? Should we be developing new approaches? Or do we need both? The innovative trial by Oakeshott et al in female college students in London provides new information about the effects on pelvic inflammatory disease (PID) of a single round of screening for Chlamydia trachomatis .1 By collecting specimens from all participants at baseline, Oakeshott and colleagues have provided the first data comparing the incidence of PID according to chlamydia infection status in women receiving immediate testing and treatment with those for whom testing and treatment were deferred by 12 months. The ethical decision to allow deferred testing is justified by the uncertainty about the incidence of PID in the community before the start of the trial, the low observed incidence in practice and the advice for all study participants about the availability of free chlamydia testing. The investigators randomised and followed 2529 women (mean age 20.9 years) and collected outcome data on 2377 (94%) from the women or their GPs. They obtained information from medical records of suspected PID cases and …

We were disappointed that Gornall's article1 was published without a response from us. It added nothing new.2 3 Our paper reviewed the first 57 deaths on the CONI (Care Of Next Infant), programme. We reaffirm that nine deaths were inevitable (recognised cause), and of the 48 unexpected deaths, seven were probable homicide. Professor Emery led the CONI …

BackgroundOlder patients compose approximately 30% of trauma patients treated in the USA but make up nearly 50% of deaths from trauma. To help standardize and elevate care of these patients, the American College of Surgeons (ACS) Trauma Quality Improvement Program’s best practice guidelines for geriatric trauma management was published in 2013 and that for palliative care was published in 2017. Here, we discuss how palliative care and geriatrics quality metrics can be tracked and used for performance improvement and leveraged as a strength for trauma verification.MethodsWe discuss the viewpoint of the ACS Verification, Review, and Consultation and three case studies, with practical tips and takeaways, of how these measures have been implemented at different institutions.ResultsWe describe the use of (1) targeted educational initiatives, (2) development of a consultation tool based on institutional resources, and (3) application of a nurse-led frailty screen.DiscussionSpecialized care and attention to these vulnerable populations is recommended, but the implementation of these programs can take many shapes.Level of evidence V

IntroductionPersonal protective equipment shortages require the reuse of N95 respirators. We sought the necessary conditions for ozone to disinfect N95 respirators for reuse and the effects of multiple cycles of exposure.MethodsPortions of 3M 1870 N95 respirators were exposed to ozone at 400 ppm with 80% humidity for 2 hours to determine effectiveness of ozone on killing Pseudomonas aeruginosa. Entire 3M 1870 N95 respirators were exposed to five cycles of 400 ppm with 80% or higher humidity for 2 hours then evaluated for ozone’s effects on airflow resistance, filtration efficiency, strap strength and quantitative fit.ResultsOzone exposure disinfected 3M 1870 N95 respirators heavily inoculated with P. aeruginosa. Ozone exposure did not negatively affect the airflow resistance, filtration efficiency, strap strength or fit of the 3M 1870 N95 respirator.DiscussionThese results suggest that ozone is a feasible strategy to disinfect N95 respirators for reuse during this and future pandemics.

BackgroundCompartment syndrome is the excess swelling within an inelastic compartment leading to excessive compartment pressure. Lower limb trauma has a high risk of compartment syndrome, which is typically mitigated using a two-incision fasciotomy. Our previous findings showed surgeons sometimes perform incomplete fasciotomies due to misidentifying the septum between the lateral and superficial posterior compartments as the septum between the anterior and lateral compartments. We conjectured this may be due to variability in the septal position between individuals leading to misinterpretation of the septal identity.MethodsA retrospective analysis was performed using CT angiograms to analyze septal position between the anterior and lateral compartments of the leg of 100 patients randomly selected from the University of Maryland Shock Trauma Center database.ResultsAnalysis of septal position showed that (1) as the septum progresses distally down the leg, the relative septum position shifts anteriorly; and that (2) there was considerable variability in the intermuscular septum position between individuals even when accounting for the anterior to posterior progression of septal position.DiscussionThis variability could lead to erroneous septal identification in individuals with a very anteriorly located septum during a leg fasciotomy with the classic initial incision being insufficiently anterior. We propose making the lateral initial incision ‘two finger breadths posterior the tibia’ rather than the traditional ‘one finger breadth anterior’ to the fibula. This moves the initial incision slightly anteriorly, uses the more readily palpable tibia, and makes the medial and lateral incisions symmetrical at ‘two finger breadths’ from the tibia, simplifying the procedure.Level of evidenceLevel 3.

BackgroundThe 2018 National Academies of Sciences, Engineering, and Medicine Report found substantial evidence that electronic cigarette use (vaping) by youth is strongly associated with an increased risk of ever using cigarettes (smoking) and moderately associated with progressing to more established smoking. However, the Report also noted that recent increases in vaping have been associated with declining rates of youth smoking. This paper examines the temporal relationship between vaping and youth smoking using multiple data sets to explore the question of whether vaping promotes smoking initiation in the USA.MethodsUsing publicly available, nationally representative data on smoking and vaping among youth and young adults, we conducted a trend line analysis of deviations from long-term trends in smoking starting from when vaping became more prevalent.ResultsThere was a substantial increase in youth vaping prevalence beginning in about 2014. Time trend analyses showed that the decline in past 30-day smoking prevalence accelerated by two to four times after 2014. Indicators of more established smoking rates, including the proportion of daily smokers among past 30-day smokers, also decreased more rapidly as vaping became more prevalent.ConclusionsThe inverse relationship between vaping and smoking was robust across different data sets for both youth and young adults and for current and more established smoking. While trying electronic cigarettes may causally increase smoking among some youth, the aggregate effect at the population level appears to be negligible given the reduction in smoking initiation during the period of vaping’s ascendance.

Generally, medical quizzes, multiple-choice questions (MCQs) and other types of mock exams are either created on Microsoft PowerPoint or are paper based. During these sessions, only a few participants are willing to discuss their answers, and it has the risk of becoming a didactic tutorial with minimal interaction, particularilywith larger groups. Kahoot! can be used as a technology-enhanced medium for delivering these types of sessions. It encourages an interactive side to the quiz, promotes fun and competition and thus can get students more motivated in answering questions. Likewise, social learning aspects can be introduced even to bigger groups, so that students can learn from one another by discussing why a particular answer is correct or incorrect. Kahoot! is an application used frequently in primary and secondary schools but less so in adult learning, although it is gaining popularity.1 Presentations are created on the Kahoot! website with the opportunity to upload images. There are options for both private and public quizzes. Participants can then …

Both electronic health (eHealth) and mobile health (mHealth) are becoming prominent components of healthcare. In order for healthcare electronic services to be safe and effective and add genuine value to the system, the European Association of Hospital Pharmacists (EAHP) believes that these should be developed in close collaboration with healthcare professionals including hospital pharmacists, and patients. Consequently, the EAHP calls in its position paper upon national governments and health systems across Europe to work towards (1) systematic and European Union-wide achievement of electronic prescribing, administration and use of electronic medical records; (2) ensuring barcoding of medicines to the single units in primary packages to enable more widespread take-up of bedside scanning in European hospitals, thus improving patient safety; (3) appropriate regulatory oversight mechanisms for mHealth applications to ensure that they have a positive impact and adequately protect patient data; (4) provision of appropriate eHealth/mHealth training opportunities to healthcare professionals and promotion of digital health literacy; and (5) involvement of hospital pharmacists in the design, specification of parameters and evaluation of information and communication technology within the medicines processes.

Objective To determine if Allen Carr’s Easyway to Stop Smoking (AC) was superior to Quit.ie in a randomised clinical trial (RCT). Setting Single centre, open RCT, general population based. Participants 300 adult smokers, 18 years plus, minimum 5 cigarettes daily, and English speaking. AC, 151 (females 44.4%) and Quit.ie, 149 (females 45.6%), mean age 44 years. outcomes for all 300 were analysed (intention-to-treat). Recruited through advertisement from July 2015 to February 2016. Intervention Randomly assigned to AC (n=151) and Quit.ie (n=149), matched for age, sex and education. Block randomisation, enrolment and follow-up at 1, 3, 6 and 12 months. Primary aim was to determine if AC had higher quit rates than Quit.ie service at 3 months. Secondary aims: quit rates at 1, 6 and 12 months and analysis of associated factors including weight. AC consisted of a 5-hour seminar, in a group setting. Quit.ie is an online portal for smoking cessation. Results AC had higher quit rates at 1, 3, 6 and 12 months. AC: 38%, (n=57), 27% (n=40), 23% (n=35), 22% (n=33) vs Quit.ie: 20% (n=30), 15% (n=22), 15% (n=23), 11% (n=17), respectively (all p values

The current morbidity of rib plating is due to the size of the incision required to perform an open procedure. We describe a minimally invasive laparoscopic approach to rib plating. A cadaver model was used to develop the surgical technique by performing both left and right posterior-lateral rib plating. A small incision was made over the auscultatory triangle. The potential working space is developed under the posterior shoulder girdle and the scapula. A table-based retractor was used to elevate the scapula and the muscles. Two separate ports were placed: one camera port and one working port. In three cadaver models, 12 rib fractures were plated and the surgical technique is described. This novel technique will likely allow for faster recovery and was especially useful in the subscapular space.Level of evidence II.

BackgroundThe Healthy China 2030 strategy sets ambitious targets for China’s policy-makers, including a decrease in the smoking rate from 27.7% in 2015 to 20% by 2030. China has made progress on tobacco control in recent years, but many key measures remain underused. This study explores the potential for full implementation of these measures to achieve the targeted reduction in smoking by 2030.MethodsFirst, a ‘business as usual’ scenario for China’s cigarette market was developed based only on underlying economic parameters. Second, non-price tobacco control measures were then added assuming they are fully implemented by 2030. Third, excise per pack was raised to a level that would increase the real price of cigarettes by 50% in 2030.FindingsUnder the business as usual scenario, the rate of smoking falls to around 26.6% in 2030. When non-price measures are included, the rate of smoking falls to 22.0% (20.9%~23.1%). Thus, non-price measures alone are unlikely to achieve the Healthy China target. Under the third scenario, excise per pack was roughly doubled in 2030 in order to increase real cigarette prices by 50%. The rate of smoking then falls to 19.7% (18.2%~21.3%), reflecting 78 million (59~97 million) fewer smokers compared with 2016. In addition, real excise revenue from cigarettes increases by 21% (−3%~47%) compared with 2016.ConclusionSignificantly higher tobacco taxes will be needed to achieve Healthy China 2030 target for reduced smoking even after the implementation of other tobacco control measures.

BackgroundAt its sixth meeting (Moscow, November 2014), the Conference of the Parties (COP) adopted decision FCTC/COP6(13) that called for an impact assessment to ‘examine the impact of the WHO Framework Convention on Tobacco Control (FCTC) on the implementation of tobacco control measures and on the effectiveness of its implementation’ after its first 10 years. An independent expert group (EG) was established to conduct the impact assessment, and report their findings at COP7 (Delhi, November 2016). This article describes the methodology used by the EG to conduct the first comprehensive multi-method assessment of the possible causal impact of the FCTC on global tobacco control over the past decade.MethodsThe EG developed and followed a four-stage process model to conduct the impact assessment: (1) desk review of literature on FCTC impact; (2) collection and analysis of interview data from 12 country missions; (3) data synthesis and interpretation; and (4) preparation of a final report.ConclusionsThe EG developed and engaged in a transparent and systematic process to conduct the FCTC impact assessment. The methods employed were rigorous, and explicitly guided by concerns about the difficulty of ascribing cause-and-effect relations. The EG’s report and supporting documents represent important sources of the positive impact of the Convention over its first decade. As development of the FCTC increasingly shifts to mechanisms for accelerating global implementation, the EG’s process model can be used as a methodology to assist Parties in carrying out their own assessments of the impact of the Treaty.

BackgroundSince the WHO Framework Convention on Tobacco Control’s (FCTC) entry into force, the tobacco industry has initiated litigation challenging tobacco control measures implemented by governments around the world, or supported others to initiate such litigation on its behalf. In defending their tobacco control measures against such litigation, governments have invoked their obligations and rights under the WHO FCTC. We assess the extent to which the WHO FCTC has provided legal weight to governments’ defences against legal challenge.MethodsWe reviewed 96 court decisions concerning legal challenges to tobacco control measures, determining whether or not they cited the WHO FCTC and their outcomes. We then reviewed the cases where the WHO FCTC was cited, analysing how the WHO FCTC contributed to the resolution of the case.ResultsThe WHO FCTC was cited in 45 decisions. Decisions both citing and not citing the WHO FCTC were largely decided in favour of governments, with 80% of WHO-FCTC-citing and 67% of non-WHO-FCTC-citing cases upholding the measure in its entirety and on every ground of challenge. In cases where it was cited, the WHO FCTC contributed to the resolution of the case in favour of governments by providing a legal basis for measures, demonstrating the measure’s public health purpose, demonstrating the evidence in favour of a measure, demonstrating international consensus, demonstrating that a measure promotes or protects health-related human rights and demonstrating whether or not a measure is reasonable, proportionate or justifiable.ConclusionsThe way the WHO FCTC has been cited in court decisions suggests that it has made a substantial contribution to courts’ reasoning in tobacco control legal challenges and has strengthened governments’ arguments in defending litigation.

ObjectiveDescribe the extent to which tobacco industry marketing tactics incorporated American Indian culture and traditional tobacco.MethodsA keyword search of industry documents was conducted using document archives from the Truth Tobacco Documents Library. Tobacco industry documents (n=76) were analysed for themes.ResultsTobacco industry marketing tactics have incorporated American Indian culture and traditional tobacco since at least the 1930s, with these tactics prominently highlighted during the 1990s with Natural American Spirit cigarettes. Documents revealed the use of American Indian imagery such as traditional headdresses and other cultural symbols in product branding and the portrayal of harmful stereotypes of Native people in advertising. The historical and cultural significance of traditional tobacco was used to validate commercially available tobacco.ConclusionsThe tobacco industry has misappropriated culture and traditional tobacco by misrepresenting American Indian traditions, values and beliefs to market and sell their products for profit. Findings underscore the need for ongoing monitoring of tobacco industry marketing tactics directed at exploiting Native culture and counter-marketing tactics that raise awareness about the distinction between commercial and traditional tobacco use. Such efforts should be embedded within a culturally sensitive framework to reduce the burden of commercial tobacco use.