Reliable tools to inform outpatient management of childhood pneumonia in resource-limited settings are needed. We investigated the value added by biomarkers of the host infection response to the performance of the Liverpool quick Sequential Organ Failure Assessment score (LqSOFA), for triage of children presenting with pneumonia to a primary care clinic in a refugee camp on the Thailand-Myanmar border. 900 consecutive presentations of children aged\u2009\u2264\u200924\u00a0months meeting WHO pneumonia criteria were included. The primary outcome was receipt of supplemental oxygen. We compared discrimination of a clinical risk score (LqSOFA) to markers of endothelial injury (Ang-1, Ang-2, sFlt-1), immune activation (CHI3L1, IP-10, IL-1ra, IL-6, IL-8, IL-10, sTNFR-1, sTREM-1), and inflammation (CRP, PCT), and quantified the net benefit of including biomarkers alongside LqSOFA. We evaluated the differential contribution of LqSOFA and host biomarkers to the diagnosis and prognosis of pneumonia severity. 49/900 (5.4%) presentations met the primary outcome. Discrimination of LqSOFA and Ang-2, the best performing biomarker, were comparable (AUC 0.82 [95% CI 0.76-0.88] and 0.81 [95% CI 0.74-0.87] respectively). Combining Ang-2 with LqSOFA improved discrimination (AUC 0.91; 95% CI 0.87-0.94; p\u2009
\n \n\n \n \nBackground: Many patients are currently unable to access psychological treatments for post-traumatic stress disorder (PTSD), and it is unclear which types of therapist-assisted internet-based treatments work best. We aimed to investigate whether a novel internet-delivered cognitive therapy for PTSD (iCT-PTSD), which implements all procedures of a first-line, trauma-focused intervention recommended by the UK National Institute for Health and Care Excellence (NICE) for PTSD, is superior to internet-delivered stress management therapy for PTSD (iStress-PTSD), a comprehensive cognitive behavioural treatment programme focusing on a wide range of coping skills. Methods: We did a single-blind, randomised controlled trial in three locations in the UK. Participants (\u226518 years) were recruited from UK National Health Service (NHS) Improving Access to Psychological Therapies (IAPT) services or by self-referral and met DSM-5 criteria for PTSD to single or multiple events. Participants were randomly allocated by a computer programme (3:3:1) to iCT-PTSD, iStress-PTSD, or a 3-month waiting list with usual NHS care, after which patients who still met PTSD criteria were randomly allocated (1:1) to iCT-PTSD or iStress-PTSD. Randomisation was stratified by location, duration of PTSD (<18 months or \u226518 months), and severity of PTSD symptoms (high vs low). iCT-PTSD and iStress-PTSD were delivered online with therapist support by messages and short weekly phone calls over the first 12 weeks (weekly treatment phase), and three phone calls over the next 3 months (booster phase). The primary outcome was the severity of PTSD symptoms at 13 weeks after random assignment, measured by self-report on the PTSD Checklist for DSM-5 (PCL-5), and analysed by intention-to-treat. Safety was assessed in all participants who started treatment. Process analyses investigated acceptability and compliance with treatment, and candidate moderators and mediators of outcome. The trial was prospectively registered with the ISRCTN registry, ISRCTN16806208. Findings: Of the 217 participants, 158 (73%) self-reported as female, 57 (26%) as male, and two (1%) as other; 170 (78%) were White British, 20 (9%) were other White, six (3%) were Asian, ten (5%) were Black, eight (4%) had a mixed ethnic background, and three (1%) had other ethnic backgrounds. Mean age was 36\u00b736 years (SD 12\u00b711; range 18\u201371 years). 52 (24%) participants met self-reported criteria for ICD-11 complex PTSD. Fewer than 10% of participants dropped out of each treatment group. iCT-PTSD was superior to iStress-PTSD in reducing PTSD symptoms, showing an adjusted difference on the PCL-5 of \u20134\u00b792 (95% CI \u20138\u00b792 to \u20130\u00b792; p=0\u00b7016; standardised effect size d=0\u00b738 [0\u00b707 to 0\u00b769]) for immediate allocations and \u20135\u00b782 (\u20139\u00b759 to \u20132\u00b704; p=0\u00b70027; d=0\u00b744 [0\u00b715 to 0\u00b772]) for all treatment allocations. Both treatments were superior to the waiting list for PCL-5 at 13 weeks (d=1\u00b767 [1\u00b723 to 2\u00b710] for iCT-PTSD and 1\u00b729 [0\u00b785 to 1\u00b772] for iStress-PTSD). The advantages in outcome for iCT-PTSD were greater for participants with high dissociation or complex PTSD symptoms, and mediation analyses showed both treatments worked by changing negative meanings of the trauma, unhelpful coping, and flashback memories. No serious adverse events were reported. Interpretation: Trauma-focused iCT-PTSD is effective and acceptable to patients with PTSD, and superior to a non-trauma-focused cognitive behavioural stress management therapy, suggesting that iCT-PTSD is an effective way of delivering the contents of CT-PTSD, one of the NICE-recommended first-line treatments for PTSD, while reducing therapist time compared with face-to-face therapy. Funding: Wellcome Trust, UK National Institute for Health and Care Research Oxford Health Biomedical Research Centre.
\n \n\n \n \nThe sources of bias in medication adherence research have not been comprehensively explored. We aimed to identify biases expected to affect adherence research and to develop a framework for mapping these onto the phases of adherence (initiation, implementation, and discontinuation). A literature search was conducted, key papers were reviewed and a Catalogue of Bias was consulted. The specific biases related to adherence measurement and metrics were mapped onto the phases of adherence using a tabular matrix. Twenty-three biases were identified, of which 11 were specifically relevant to adherence measures and metrics. The mapping framework showed differences in the numbers and types of biases associated with each measure and metric while highlighting those common to many adherence study designs (e.g. unacceptability bias, apprehension bias). The framework will inform the design of adherence studies and the development of risk of bias tools for adherence research.
\n \n\n \n \nOBJECTIVE: To understand: if professionals, citizens and patients can locate UK healthcare professionals' statements of declarations of interests, and what citizens understand by these. DESIGN: The study sample included two groups of participants in three phases. First, healthcare professionals working in the public domain (health professional participants, HPP) were invited to participate. Their conflicts and declarations of interest were searched for in publicly available data, which the HPP checked and confirmed as the 'gold standard'. In the second phase, laypeople, other healthcare professionals and healthcare students were invited to complete three online tasks. The first task was a questionnaire about their own demographics. The second task was questions about doctors' conflicts of interest in clinical vignette scenarios. The third task was a request for each participant to locate and describe the declarations of interest of one of the named healthcare professionals identified in the first phase, randomly assigned. At the end of this task, all lay participants were asked to indicate willingness to be interviewed at a later date. In the third phase, each lay respondent who was willing to be contacted was invited to a qualitative interview to obtain their views on the conflicts and declaration of interest they found and their meaning. SETTING: Online, based in the UK. PARTICIPANTS: 13 public-facing health professionals, 379 participants (healthcare professionals, students and laypeople), 21 lay interviewees. OUTCOME MEASURES: (1) Participants' level of trust in professionals with variable conflicts of interest, as expressed in vignettes, (2) participants' ability to locate the declarations of interest of a given well-known healthcare professional and (3) laypeoples' understanding of healthcare professionals declarations and conflicts of interest. RESULTS: In the first phase, 13 health professionals (HPP) participated and agreed on a 'gold standard' of their declarations. In the second phase, 379 citizens, patients, other healthcare professionals and students participated. Not all completed all aspects of the research. 85% of participants thought that knowing about professional declarations was definitely or probably important, but 76.8% were not confident they had found all relevant information after searching. As conflicts of interest increased in the vignettes, participants trusted doctors less. Least trust was associated with doctors who had not disclosed their conflicts of interest. 297 participants agreed to search for the HPP 'gold standard' declaration of interest, and 169 reported some data. Of those reporting any findings, 61 (36%) located a relevant link to some information deemed fit for purpose, and 5 (3%) participants found all the information contained in the 'gold standard'. In the third phase, qualitative interviews with 21 participants highlighted the importance of transparency but raised serious concerns about how useful declarations were in their current format, and whether they could improve patient care. Unintended consequences, such as the burden for patients and professionals to use declarations were identified, with participants additionally expressing concerns about professional bias and a lack of insight over conflicts. Suggestions for improvements included better regulation and organisation, but also second opinions and independent advice where conflicts of interest were suspected. CONCLUSION: Declarations of interest are important and conflicts of interest concern patients and professionals, particularly in regard to trust in decision-making. If declarations, as currently made, are intended to improve transparency, they do not achieve this, due to difficulties in locating and interpreting them. Unintended consequences may arise if transparency alone is assumed to provide management of conflicts. Increased trust resulting from transparency may be misplaced, given the evidence on the hazards associated with conflicts of interest. Clarity about the purposes of transparency is required. Future policies may be more successful if focused on reducing the potential for negative impacts of conflicts of interest, rather than relying on individuals to locate declarations and interpret them. TRIAL REGISTRATION NUMBER: The protocol was pre-registered at https://osf.io/e7gtq.
\n \n\n \n \nBackground: The purpose of this study is to develop a theory-driven understanding of the barriers and facilitators underpinning physicians\u2019 attitudes and capabilities to implementing SARS-CoV-2 point-of-care (POC) testing into primary care practices. Methods: We used a secondary qualitative analysis approach to re-analyse data from a qualitative, interview study of 22 primary care physicians from 21 primary care practices across three regions in England. We followed the three-step method based on the Behaviour Change Wheel to identify the barriers to implementing SARS-CoV-2 POC testing and identified strategies to address these challenges. Results: Several factors underpinned primary care physicians\u2019 attitudes and capabilities to implement SARS-CoV-2 POC testing into practice. First, limited knowledge of the SARS-CoV-2 POC testing landscape and a demanding workload affected physicians\u2019 willingness to use the tests. Second, there was scepticism about the insufficient evidence pertaining to the clinical efficacy and utility of POC tests, which affected physicians\u2019 confidence in the accuracy of tests. Third, physicians would adopt POC tests if they were prescribed and recommended by authorities. Fourth, physicians required professional education and training to increase their confidence in using POC tests but also suggested that healthcare assistants should administer the tests. Fifth, physicians expressed concerns about their limited workload capacity and that extra resources are needed to accommodate any anticipated changes. Sixth, information sharing across practices shaped perceptions of POC tests and the quality of information influenced physician perceptions. Seventh, financial incentives could motivate physicians and were also needed to cover the associated costs of testing. Eighth, physicians were worried that society will view primary care as an alternative to community testing centres, which would change perceptions around their professional identity. Ninth, physicians\u2019 perception of assurance/risk influenced their willingness to use POC testing if it could help identify infectious individuals, but they were also concerned about the risk of occupational exposure and potentially losing staff members who would need to self-isolate. Conclusions: Improving primary care physicians\u2019 knowledgebase of SARS-CoV-2 POC tests, introducing policies to embed testing into practice, and providing resources to meet the anticipated demands of testing are critical to implementing testing into practice.
\n \n\n \n \nBACKGROUND: Sleep disturbance (SD) is common among people living with dementia (PLwD) or mild cognitive impairment (MCI). It has a significant impact on the wellbeing of PLwD and caregivers, and makes care at home more difficult. Within primary care, assessment and management of SD for this population is complex and challenging. AIM: To identify what works, how, and for whom, in the assessment and management of SD for PLwD or MCI in primary care. METHOD: We conducted a realist review to develop explanations of causal relationships, using context-mechanism-outcome configurations (CMOCs). An initial programme theory was iteratively tested and refined, using data from relevant literature and stakeholder feedback. The study followed RAMESES reporting quality. RESULTS: In total, 71 papers from OECD countries were included for analysis, generating 19 CMOCs. Low awareness of SD and assessment methods resulted in underdiagnosis in primary care. Assessment and treatment of PLwD/MCI were, respectively, more challenging when people were unable to accurately report concerns or implement interventions independently. Sedative medication was commonly used to manage SD, often driven by low confidence in nonpharmacological strategies. Long-term medication use was common despite guidelines indicating limited efficacy, which was driven by perceived pressures to prescribe or concerns of relapse. In nursing homes, environments and routines could exacerbate SD. CONCLUSION: Increasing awareness, knowledge, and confidence in diagnosis and assessment of SD is needed. Primary care-specific assessment tools may help. Long-term medication use is the default option in absence of pragmatic and effective non-pharmacological interventions that can be easily incorporated into routine general practice.
\n \n\n \n \nBACKGROUND AND OBJECTIVE: Point-of-care lateral flow device antigen testing has been used extensively to identify individuals with active SARS-CoV-2 infection in the community. This study aimed to evaluate the diagnostic accuracy of two point-of-care tests (POCTs) for SARS-CoV-2 in routine community care. METHODS: Adults and children with symptoms consistent with suspected current COVID-19 infection were prospectively recruited from 19 UK general practices and two COVID-19 testing centres between October 2020 and October 2021. Participants were tested by trained healthcare workers using at least one of two index POCTs (Roche-branded SD Biosensor Standard\u2122 Q SARS-CoV-2 Rapid Antigen Test and/or BD Veritor\u2122 System for Rapid Detection of SARS-CoV-2). The reference standard was laboratory triplex reverse transcription quantitative PCR (RT-PCR) using a combined nasal/oropharyngeal swab. Diagnostic accuracy parameters were estimated, with 95% confidence intervals (CIs), overall, in relation to RT-PCR cycle threshold and in pre-specified subgroups. RESULTS: Of 663 participants included in the primary analysis, 39.2% (260/663, 95% CI 35.5% to 43.0%) had a positive RT-PCR result. The SD Biosensor POCT had sensitivity 84.0% (178/212, 78.3% to 88.6%) and specificity 98.5% (328/333, 96.5% to 99.5%), and the BD Veritor POCT had sensitivity 76.5% (127/166, 69.3% to 82.7%) and specificity 98.8% (249/252, 96.6% to 99.8%) compared with RT-PCR. Sensitivity of both devices dropped substantially at cycle thresholds \u226530 and in participants more than 7 days after onset of symptoms. CONCLUSIONS: Both POCTs assessed exceed the Medicines and Healthcare products Regulatory Agency target product profile's minimum acceptable specificity of 95%. Confidence intervals for both tests include the minimum acceptable sensitivity of 80%. In symptomatic patients, negative results on these two POCTs do not preclude the possibility of infection. Tests should not be expected to reliably detect disease more than a week after symptom onset, when viral load may be reduced. REGISTRATION: ISRCTN142269.
\n \n\n \n \nThe pediatric population receives the majority of vaccines globally, yet there is a paucity of studies on the transcriptional response induced by immunization in this special population. In this study, we performed a systems-level analysis of immune responses to the trivalent inactivated influenza vaccine adjuvanted with MF-59 in children (15\u201324 months old) and in young, healthy adults. We analyzed transcriptional responses elicited by vaccination in peripheral blood, as well as cellular and antibody responses following primary and booster vaccinations. Our analysis revealed that primary vaccination induced a persistent transcriptional signature of innate immunity; booster vaccination induced a transcriptional signature of an enhanced memory-like innate response, which was consistent with enhanced activation of myeloid cells assessed by flow cytometry. Furthermore, we identified a transcriptional signature of type 1 interferon response post-booster vaccination and at baseline that was correlated with the local reactogenicity to vaccination and defined an early signature that correlated with the hemagglutinin antibody titers. These results highlight an adaptive behavior of the innate immune system in evoking a memory-like response to secondary vaccination and define molecular correlates of reactogenicity and immunogenicity in infants.
\n \n\n \n \nBackground: At the outset of the COVID-19 pandemic, there was no routine comprehensive hospital medicines data from the UK available to researchers. These records can be important for many analyses including the effect of certain medicines on the risk of severe COVID-19 outcomes. With the approval of NHS England, we set out to obtain data on one specific group of medicines, \"high-cost drugs\" (HCD) which are typically specialist medicines for the management of long-term conditions, prescribed by hospitals to patients. Additionally, we aimed to make these data available to all approved researchers in OpenSAFELY-TPP. This report is intended to support all studies carried out in OpenSAFELY-TPP, and those elsewhere, working with this dataset or similar data. Methods: Working with the North East Commissioning Support Unit and NHS Digital, we arranged for collation of a single national HCD dataset to help inform responses to the COVID-19 pandemic. The dataset was developed from payment submissions from hospitals to commissioners. Results: In the financial year (FY) 2018/19 there were 2.8 million submissions for 1.1 million unique patient IDs recorded in the HCD. The average number of submissions per patient over the year was 2.6. In FY 2019/20 there were 4.0 million submissions for 1.3 million unique patient IDs. The average number of submissions per patient over the year was 3.1. Of the 21 variables in the dataset, three are now available for analysis in OpenSafely-TPP: Financial year and month of drug being dispensed; drug name; and a description of the drug dispensed. Conclusions: We have described the process for sourcing a national HCD dataset, making these data available for COVID-19-related analysis through OpenSAFELY-TPP and provided information on the variables included in the dataset, data coverage and an initial descriptive analysis.
\n \n\n \n \nOBJECTIVE: To assess the sex difference in hospital mortality following ST elevation myocardial infarction (STEMI) in China. DESIGN: Observational study of patients enrolled into a large trial, adjusting for age, presenting characteristics and hospital treatments using logistic regression. SETTINGS: 1250 hospitals in China during 1999-2005. PATIENTS: 42\u2005683 STEMI patients, including 31\u2005309 men and 11\u2005374 women. INTERVENTION: In the original trial, all patients received 162\u2005mg of aspirin plus 75\u2005mg of clopidogrel daily or matching placebo and metoprolol (15\u2005mg intravenous then 200\u2005mg oral daily) or matching placebo. All other aspects of patients' treatments were at the discretion of responsible doctors. MAJOR OUTCOMES: Hospital mortality from any cause during the scheduled trial treatment period (ie, up to 4\u2005weeks in hospital). RESULTS: Overall, 8% of the patients died in hospital, with the crude hospital mortality being twice as high in women as in men (12.6% vs 6.3%). After adjusting for age, the sex difference in hospital mortality attenuated but remained highly significant (OR 1.54; 95% CI 1.43 to 1.66). Further adjustment for other baseline characteristics and for the treatments given in hospital had little effect on the sex difference in hospital mortality (OR 1.50, 95% CI 1.38 to 1.62). The difference in hospital mortality was greater at a younger age, with the adjusted ORs being 2.14, 1.70, 1.48 and 1.18, respectively, for ages <55, 55-64, 65-74 and \u226575\u2005years (p=0.0001 for trend). CONCLUSION: Compared with men of the same age, women had approximately a 50% higher mortality following hospital admission for STEMI, with a particularly higher excess risk at age <55\u2005years.
\n \n\n \n \nBackground Underweight and severe and morbid obesity are associated with highly elevated risks of adverse health outcomes. We estimated trends in mean body-mass index (BMI), which characterises its population distribution, and in the prevalences of a complete set of BMI categories for adults in all countries. Methods We analysed, with use of a consistent protocol, population-based studies that had measured height and weight in adults aged 18 years and older. We applied a Bayesian hierarchical model to these data to estimate trends from 1975 to 2014 in mean BMI and in the prevalences of BMI categories (<18.5 kg/m2[underweight], 18.5 kg/m2to <20 kg/m2, 20 kg/m2to <25 kg/m2, 25 kg/m2to <30 kg/m2, 30 kg/m2to <35 kg/m2, 35 kg/m2to <40 kg/m2, \u226540 kg/m2[morbid obesity]), by sex in 200 countries and territories, organised in 21 regions. We calculated the posterior probability of meeting the target of halting by 2025 the rise in obesity at its 2010 levels, if post-2000 trends continue. Findings We used 1698 population-based data sources, with more than 19.2 million adult participants (9.9 million men and 9.3 million women) in 186 of 200 countries for which estimates were made. Global age-standardised mean BMI increased from 21.7 kg/m2(95% credible interval 21.3-22.1) in 1975 to 24.2 kg/m2(24.0-24.4) in 2014 in men, and from 22.1 kg/m2(21.7-22.5) in 1975 to 24.4 kg/m2(24.2-24.6) in 2014 in women. Regional mean BMIs in 2014 for men ranged from 21.4 kg/m2in central Africa and south Asia to 29.2 kg/m2(28.6-29.8) in Polynesia and Micronesia; for women the range was from 21.8 kg/m2(21.4-22.3) in south Asia to 32.2 kg/m2(31.5-32.8) in Polynesia and Micronesia. Over these four decades, age-standardised global prevalence of underweight decreased from 13.8% (10.5-17.4) to 8.8% (7.4-10.3) in men and from 14.6% (11.6-17.9) to 9.7% (8.3-11.1) in women. South Asia had the highest prevalence of underweight in 2014, 23.4% (17.8-29.2) in men and 24.0% (18.9-29.3) in women. Age-standardised prevalence of obesity increased from 3.2% (2.4-4.1) in 1975 to 10.8% (9.7-12.0) in 2014 in men, and from 6.4% (5.1-7.8) to 14.9% (13.6-16.1) in women. 2.3% (2.0-2.7) of the world's men and 5.0% (4.4-5.6) of women were severely obese (ie, have BMI \u226535 kg/m2). Globally, prevalence of morbid obesity was 0.64% (0.46-0.86) in men and 1.6% (1.3-1.9) in women. Interpretation If post-2000 trends continue, the probability of meeting the global obesity target is virtually zero. Rather, if these trends continue, by 2025, global obesity prevalence will reach 18% in men and surpass 21% in women; severe obesity will surpass 6% in men and 9% in women. Nonetheless, underweight remains prevalent in the world's poorest regions, especially in south Asia.
\n \n\n \n \nBeing taller is associated with enhanced longevity, and higher education and earnings. We reanalysed 1472 population-based studies, with measurement of height on more than 18.6 million participants to estimate mean height for people born between 1896 and 1996 in 200 countries. The largest gain in adult height over the past century has occurred in South Korean women and Iranian men, who became 20.2 cm (95% credible interval 17.5\u201322.7) and 16.5 cm (13.3\u2013 19.7) taller, respectively. In contrast, there was little change in adult height in some sub-Saharan African countries and in South Asia over the century of analysis. The tallest people over these 100 years are men born in the Netherlands in the last quarter of 20th century, whose average heights surpassed 182.5 cm, and the shortest were women born in Guatemala in 1896 (140.3 cm; 135.8\u2013 144.8). The height differential between the tallest and shortest populations was 19-20 cm a century ago, and has remained the same for women and increased for men a century later despite substantial changes in the ranking of countries.
\n \n\n \n \nBackground: High blood pressure, blood glucose, serum cholesterol, and BMI are risk factors for cardiovascular diseases and some of these factors also increase the risk of chronic kidney disease and diabetes. We estimated mortality from cardiovascular diseases, chronic kidney disease, and diabetes that was attributable to these four cardiometabolic risk factors for all countries and regions from 1980 to 2010. Methods: We used data for exposure to risk factors by country, age group, and sex from pooled analyses of population-based health surveys. We obtained relative risks for the effects of risk factors on cause-specific mortality from meta-analyses of large prospective studies. We calculated the population attributable fractions for each risk factor alone, and for the combination of all risk factors, accounting for multicausality and for mediation of the effects of BMI by the other three risks. We calculated attributable deaths by multiplying the cause-specific population attributable fractions by the number of disease-specific deaths. We obtained cause-specific mortality from the Global Burden of Diseases, Injuries, and Risk Factors 2010 Study. We propagated the uncertainties of all the inputs to the final estimates. Findings: In 2010, high blood pressure was the leading risk factor for deaths due to cardiovascular diseases, chronic kidney disease, and diabetes in every region, causing more than 40% of worldwide deaths from these diseases; high BMI and glucose were each responsible for about 15% of deaths, and high cholesterol for more than 10%. After accounting for multicausality, 63% (10\u00b78 million deaths, 95% CI 10\u00b71-11\u00b75) of deaths from these diseases in 2010 were attributable to the combined effect of these four metabolic risk factors, compared with 67% (7\u00b71 million deaths, 6\u00b76-7\u00b76) in 1980. The mortality burden of high BMI and glucose nearly doubled from 1980 to 2010. At the country level, age-standardised death rates from these diseases attributable to the combined effects of these four risk factors surpassed 925 deaths per 100 000 for men in Belarus, Kazakhstan, and Mongolia, but were less than 130 deaths per 100 000 for women and less than 200 for men in some high-income countries including Australia, Canada, France, Japan, the Netherlands, Singapore, South Korea, and Spain. Interpretation: The salient features of the cardiometabolic disease and risk factor epidemic at the beginning of the 21st century are high blood pressure and an increasing effect of obesity and diabetes. The mortality burden of cardiometabolic risk factors has shifted from high-income to low-income and middle-income countries. Lowering cardiometabolic risks through dietary, behavioural, and pharmacological interventions should be a part of the global response to non-communicable diseases. Funding: UK Medical Research Council, US National Institutes of Health. \u00a9 2014 Elsevier Ltd.
\n \n\n \n \nBACKGROUND: Assessment of suicide risk in individuals who have self-harmed is common in emergency departments, but is often based on tools developed for other purposes. OBJECTIVE: We developed and validated a predictive model for suicide following self-harm. METHODS: We used data from Swedish population-based registers. A cohort of 53 172 individuals aged 10+ years, with healthcare episodes of self-harm, was split into development (37 523 individuals, of whom 391 died from suicide within 12 months) and validation (15 649 individuals, 178 suicides within 12 months) samples. We fitted a multivariable accelerated failure time model for the association between risk factors and time to suicide. The final model contains 11 factors: age, sex, and variables related to substance misuse, mental health and treatment, and history of self-harm. Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis guidelines were followed for the design and reporting of this work. FINDINGS: An 11-item risk model to predict suicide was developed using sociodemographic and clinical risk factors, and showed good discrimination (c-index 0.77, 95% CI 0.75 to 0.78) and calibration in external validation. For risk of suicide within 12 months, using a 1% cut-off, sensitivity was 82% (75% to 87%) and specificity was 54% (53% to 55%). A web-based risk calculator is available (Oxford Suicide Assessment Tool for Self-harm or OxSATS). CONCLUSIONS: OxSATS accurately predicts 12-month risk of suicide. Further validations and linkage to effective interventions are required to examine clinical utility. CLINICAL IMPLICATIONS: Using a clinical prediction score may assist clinical decision-making and resource allocation.
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