Ethnicity Data Research Articles

Representation in the UK MS Register: A Comparison of Nationwide Ethnicity and Register Data

BackgroundThe United Kingdom MS Register (UKMSR) collects longitudinal data on people with Multiple Sclerosis (pwMS) from clinical sources and as Patient Reported Outcomes (PROs) via a web portal. People from non-white ethnicities are often poorly represented in research and clinical trials; the UKMSR aims to be representative of people with MS (pwMS) across the UK. AimTo compare ethnic representation in the UKMSR to data from the Office for National Statistics (ONS). MethodEthnicity data was taken from the UKMSR as a ‘snapshot’ in 2024. Comparative data from ONS in England and Wales was gathered. Due to low numbers in the UKMSR of some ethnicities and areas, participants were grouped into ‘White’ and ‘All Other Ethnicities’. Using Chi-Sq tests, we compared ethnicities across ten regions of ONS 2021 Census data. ResultsTen regions were compared (nine in England, Wales as one). Analysis of both web-reported (n = 18648) and clinical (n = 5456) ethnicity found UKMSR diversity to be significantly lower than national statistics (p < .05), with the exception of the clinical Register in Wales (numbers were insufficient to test) and clinical Register in the English West Midlands. The clinical Register was more representative in 7/10 regions than the web Register. DiscussionThe clinical Register, via NHS hospital sites reaches a more diverse audience than the patient-reported web Register; further work is needed in reaching a broader audience of pwMS, as well as harmonising discrepancies between the clinical and web Register populations.

As our population changes, so must we: how race and ethnicity data merging has evolved over time in the Wisconsin Administrative Data Core

The Institute for Research on Poverty (IRP), centered at the University of Wisconsin-Madison in Wisconsin, USA, began collaboration with various Wisconsin state agencies in 1985 to link data between disparate state agencies. These initial efforts have since evolved into the Wisconsin Administrative Data Core (WADC) which is an individual-level population dataset connecting extensive administrative data spanning decades of Wisconsin social services program history. Since its purpose is to facilitate evidence-driven policymaking and support program evaluation, it is essential that our data linking efforts accurately represent our Wisconsin population. Since its inception, the WADC has adapted to changes in how race and ethnicity are collected and reported. While Wisconsin has a racial makeup that is generally less diverse than the national population, the number of non-white and multi-racial identifying residents has increased over time. Furthermore, varying state agency demographic collection and reporting methods have fueled the need for our linking methods to change, too. IRP initially implemented standard data linkage methods using a mixture of probabilistic and deterministic matching of personal identifying information. But as the racial composition of Wisconsin residents changed over time, our linking assumptions induced implicit biases. In response, we updated our matching algorithm to account for the cultural nuances in how personally identifying information is assigned and reported within various racial and ethnic subgroups. Furthermore, we prioritized values from data sources that were self-reported rather than assigned from a third-party. These methodological modifications have improved the WADC’s reliability and representativeness of the population.

Error Rates in Race and Ethnicity Designation Across Large Pediatric Health Systems

Without knowledge of the degree of misattribution in racial and ethnic designations in data, studies run the risk of missing existing inequities and disparities and identifying others that do not exist. Further, accuracy of racial and ethnic designations is important to clinical care improvement efforts and health outcomes. To determine the error rate of racial and ethnic attribution in the electronic medical records (EMRs) across the 3 largest pediatric health systems in Michigan. This cross-sectional study collected race and ethnicity data from parents in outpatient clinics, emergency departments, and inpatient units at the 3 largest pediatric health systems in Michigan. A total of 1594 parents or guardians participated at health system A, 1537 at health system B, and 1202 at health system C from September 1, 2023, to January 31, 2024. Parent or guardian report of race and ethnicity for a child was used as the gold standard for comparison with the designation in the EMR. Race and ethnicity designations in the EMR. Options for race designation across the health systems ranged from 6 to 49; options for ethnicity, from 2 to 10. Matching occurred in 3 stages. First, the exact racial and ethnic designations made by parents for their child were compared with what was found in the EMR. Second, for any child whose parent selected more than 1 racial category or for whom more than 1 appeared in the EMR, the designation of a minoritized racial group was used for matching purposes. Third, starting with the product of stage 2, racial designations were combined or collapsed into 6 (health systems A and C) or 5 (health system B) designations. A total of 4333 survey responses were included in the analysis. The greatest error rate across the health systems occurred with the exact match of parental report of racial designation with the EMR, which ranged from 41% to 78% across the health systems. Improvement in the matching rate for each health system occurred with consolidation of race options provided. Differences between the health systems narrowed at the final consolidation to varying from 79% to 88% matching. Ethnicity matching between the EMR and the parental report ranged from 65% to 95% across the health systems. Missing race or ethnicity data in the EMR was counted as a nonmatch. Rates of missing racial data varied across the health systems from 2% to 10%. The health system with the greatest number of options for race and ethnicity had the highest error rates. Although there will always be some misattribution of race and ethnicity in the EMR, the results of this cross-sectional study suggest that significant error in these data may undermine strategies to improve care. It is unclear whether those in an organization who determine the number of potential categories are the same persons who use those data to investigate potential disparities and inequities.

Zooming in to Advance Health Equity for Heart Failure—Disaggregating Race, Ethnicity, and Social Data

Zooming in to Advance Health Equity for Heart Failure—Disaggregating Race, Ethnicity, and Social Data

Examining factors associated with poor metered-dose inhaler technique in a cohort of bronx patients with uncontrolled asthma

Objective Most studies investigating at-risk groups for poor inhaler technique (PT) have been in adolescents. However, evidence suggests older age correlates with PT. This study aimed to correlate patient characteristics with PT in an adult asthma cohort in the Bronx. Methods We categorized 237 patients with uncontrolled asthma by demonstration of good inhaler technique (GT) (n = 112) or PT (n = 58) at their initial visit. Independent variables included age, sex, ethnicity, language, insurance status, BMI, depression severity, and socioeconomic data. Two logistic regression models were created to assess odds of PT among independent variables at initial visit and odds of improvement in technique at follow-up. Results At the initial visit, patients with PT had a mean age of 53.74 (±13.54) versus 45.12 (±13.26) among those with GT (p= <0.001). The PT group also had a lower percentage of patients with private insurance (52.53% versus 71.15%, p = 0.037). When controlling for language, ethnicity, insurance status, and educational attainment, the odds of PT increased with age (OR, 1.051; CI, 1.017-1.087, p = 0.003) and BMI (OR, 1.065; CI, 1.010-1.123, p = 0.020). Males had lower odds of PT (OR, 0.379; CI, 0.144-0.997; p = 0.049). While insurance status did not affect odds of PT, Medicaid users had lower odds of improving technique (OR, 0.184; CI, 0.040-0.854; p = 0.031). Conclusions At baseline, individuals with PT were younger and more likely to be on a public health insurance plan. Increasing age, increasing BMI, and female sex were associated with higher odds of PT at the baseline visit, but were not associated with improvements in technique.

Genetic testing for familial hyperaldosteronism type 1 in Aotearoa/New Zealand.

Primary aldosteronism (PA) is the most common secondary endocrine cause of hypertension with familial hyperaldosteronism type 1 (FH-1), a rare heritable subtype. Timely identification of FH-1 is important because of an increased risk of vascular events in affected individuals and because it provides the opportunity to guide appropriate treatment. Genetic testing is recommended if onset is at a young age (<20 years), there is a family history of PA or early cerebrovascular events occur. To assess national rates of testing for FH-1, whether this varied over time and by region. De-identified data were obtained on genetic testing performed for FH-1 from 1 April 2010 to 30 October 2023 (163 months) from the Canterbury Health Laboratories database, the sole national testing laboratory for FH-1. A total of 147 tests were performed, of which 19 (12.9%) were positive. Eleven of the positive tests were requested by one region. Testing rates varied from 0.00 to 0.63 per 100 000 people per annum. Most tests were requested by endocrinology services. Testing increased over time from an average of 4.6 tests per annum in the first 5 years of the period studied to 17.7 tests in the most recent 5 years. Limitations include lack of ethnicity data, information on testing indications and testing rates for other familial PA subtypes. Testing for FH-1 has increased over time but remains low. Testing for familial forms of PA should be considered in those in whom PA was diagnosed at a young age or with a suggestive family history.

Validation of Patients' Race, Ethnicity, and Language Data in a Pediatric Emergency Department.

Validation of Patients' Race, Ethnicity, and Language Data in a Pediatric Emergency Department.

The Prevalence of Different Genotypic Forms of Familial Hypercholesterolemia in Relation to Race and Ethnicity

In the present study, a systematic literature review was conducted to examine the prevalence of homo- and heterozygous forms of Familial hypercholesterolemia among different racial and ethnic groups. Familial hypercholesterolemia (FH) is an inherited disorder characterised by elevated blood levels of cholesterol and low-density lipoprotein (LDL), which increases the risk of cardiovascular disease. Databases PubMed, Web of Science, and Elsiever were searched and only peer-reviewed articles with a large number of contributors and sufficient prevalence and ethnicity data were included. Diagnosis of FH was based on genetic testing or clinical criteria. The results of the study indicate inadequate and untimely diagnosis of FH, resulting in inadequate treatment. To date, only 9% of countries have statistical data on the prevalence of FH in the general population. In order to develop effective prevention strategies for cardiovascular diseases associated with FH, further research is needed to obtain accurate epidemiological data, including the race and ethnicity of patients. This will allow optimisation of strategies to reduce the burden of preventable cardiovascular disease associated with FH.&lt;br /&gt; &amp;nbsp;

Underrepresentation of Racial and Ethnic Minorities in Metastatic Colorectal Carcinoma Clinical Trials within the United States.

To investigate if underrepresentation of racial and ethnic minorities exists in metastatic colorectal carcinoma (CRC) clinical trials. Representation of vulnerable subpopulations is essential for generalizability of clinical trials. Limited studies to date have investigated racial and ethnic representation of patients enrolled in clinical trials for metastatic CRC. ClinicalTrials.gov was queried for metastatic CRC clinical trials in the United States from 2000-2020. Incidence data were extracted from the SEER Database. Enrollment fraction (EF) was defined as number of trial participants divided by U.S. incidence of metastatic CRC in each race, ethnicity, and gender. Representation Quotient (RQ) was defined as the proportion of trial participants divided by proportion of U.S. metastatic CRC incidence for each subgroup. 8084 patients from 135 clinical trials were analyzed. 49.6% of clinical trials reported race data and 34.8% reported ethnicity data. Compared to 2000-2009, 2010-2019 had increased representation data reporting for race (61.2% vs. 38.8%) and ethnicity (64.6% vs. 35.4%). Of trials with race data, White patients represented 77.0%, Black patients 6.6%, Asian/Pacific Islander (API) patients 16.1%, American Indian/Alaska Native (AIAN) patients 0.2%, and Hispanic patients 6.8%. Black patients (median RQ 0.54), API patients (median RQ 0.19), AIAN patients (median RQ 0.00), and Hispanic patients (median RQ 0.26) were underrepresented. Black patients had a higher degree of underrepresentation in clinical trials with serum creatinine inclusion criteria (RQ 0.40 vs. 0.86, P=0.034). Strategies are needed to increase minority enrollment in clinical trials for metastatic CRC. Identification of systemic barriers is integral in public policy advocacy to increase representation.

Indocyanine green near-infrared fluorescence bowel perfusion assessment to prevent anastomotic leakage in minimally invasive colorectal surgery (AVOID): a multicentre, randomised, controlled, phase 3 trial

Anastomotic leakage is a severe postoperative complication in colorectal surgery and compromised bowel perfusion is considered a major contributing factor. Conventional methods to assess bowel perfusion have a low predictive value for anastomotic leakage. We therefore aimed to evaluate the efficacy of real-time assessment with near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) in the prevention of anastomotic leakage. This multicentre, randomised, controlled, phase 3 trial was done in eight hospitals in the Netherlands. We included adults (aged >18 years) who were scheduled for laparoscopic or robotic colorectal surgery (with planned primary anastomosis) for benign and malignant diseases. Preoperatively, patients were randomly assigned (1:1) to fluorescence-guided bowel anastomosis (FGBA) or conventional bowel anastomosis (CBA) by variable block randomisation (block sizes 4, 6, and 8) and stratified by site. The operating surgeon and investigators analysing the data were not masked to group assignment. Patients were unmasked after the surgical procedure or after study end. In the FGBA group, surgeons marked anastomosis levels per conventional perfusion assessment and then administered 5 mg of ICG by 2 mL intravenous bolus. They assessed bowel perfusion using NIR fluorescence imaging and adjusted (or kept) transection lines accordingly. Only conventional methods for bowel perfusion assessment were used in the CBA group. The primary outcome was the difference in the rate of clinically relevant anastomotic leakage (ie, requiring active therapeutic intervention but manageable without reoperation [grade B] or requiring reoperation [grade C], per the International Study Group of Rectal Cancer) between the FGBA group and the CBA group within 90 days post-surgery. The primary outcome and safety were assessed in the intention-to-treat population. This study was registered with ToetsingOnline.nl (NL7502) and ClinicalTrials.gov (NCT04712032) and is complete. Between July 2, 2020, and Feb 21, 2023, 982 patients were enrolled, of whom 490 were assigned to FGBA and 492 were assigned to CBA. After excluding 51 patients, the intention-to-treat population comprised 931 (463 assigned FGBA and 468 assigned CBA). Patients had a median age of 68·0 years (IQR 59·0-75·0) and 485 (52%) were male and 446 (48%) were female. Ethnicity data were not available. The overall 90-day rate of clinically relevant anastomotic leakage was not significantly different between the FGBA group (32 [7%] of 463 patients) and the CBA group (42 [9%] of 468 patients; relative risk 0·77 [95% CI 0·50-1·20]; p=0·24). No adverse events related to ICG use were observed. 313 serious adverse events in 229 (25%) patients were at 90-day follow-up (159 serious adverse events in 113 [24%] patients in the FGBA group and 154 serious adverse events in 116 [25%] patients in the CBA group). 18 (2%) people died by 90 days (ten in the FGBA group and eight in the CBA group). ICG NIR fluorescence imaging did not reduce 90-day anastomotic leakage rates in this trial across all types of colorectal surgeries. Further research should be done in subgroups, such as rectosigmoid resections, for which evidence suggests ICG NIR might be beneficial. Olympus Medical, Diagnostic Green, and Intuitive Foundation.

Race, ethnicity, and risk for colonization and infection with key bacterial pathogens: a scoping review.

Racial and ethnic disparities in infectious disease burden have been reported in the USA and globally, most recently for COVID-19. It remains unclear whether such disparities also exist for priority bacterial pathogens that are increasingly antimicrobial-resistant. We conducted a scoping review to summarize published studies that report on colonization or community-acquired infection with pathogens among different races and ethnicities. We conducted an electronic literature search of MEDLINE®, Daily, Global Health, Embase, Cochrane Central, and Web of Science from inception to January 2022 for eligible observational studies. Abstracts and full-text publications were screened in duplicate for studies that reported data for race or ethnicity for at least one of the pathogens of interest. Fifty-four observational studies in 59 publications met our inclusion criteria. Studies reported results for Staphylococcus aureus (n=56), Escherichia coli (n=8), Pseudomonas aeruginosa (n=2), Enterobacterales (n=1), Enterococcus faecium (n=1), and Klebsiella pneumoniae (n=1), and were conducted in the USA (n=42), Israel (n=5), New Zealand (n=4), Australia (n=2), and Brazil (n=1). USA studies most often examined Black and Hispanic minority groups and regularly reported a higher risk of these pathogens in Black persons and mixed results for Hispanic persons. Ethnic minority groups were often reported to be at a higher risk in other countries. Sufficient evidence was identified to justify systematic reviews and meta-analyses evaluating the relationship between race, ethnicity, and community-acquired S. aureus and E. coli, although data were rare for other pathogens. We recommend that future studies clarify whether race and ethnicity data are self-reported, collect race and ethnicity data in conjunction with the social determinants of health, and make a concerted effort to include non-English speakers and Indigenous populations from the Americas, when possible.

THE FORECAST STUDY: FACTORS PREDICTING PAIN PERSISTENCE IN SCIATICA. AN UPDATE ON BASELINE AND PRELIMINARY LONGITUDINAL DATA

BackgroundFORECAST is a prospective longitudinal cohort study exploring mechanism-based prognostic factors for pain persistence in sciatica. Here, we share an update on this largest deeply-phenotyped primary care sciatica cohort.Methods/resultsOur cohort includes 180 people with sciatica (score &gt;4 on Stynes’ Sum Score), aged 18–85, within 3 months of symptom onset. Psychosocial factors, self-reported sensory profiling, clinical examination, quantitative sensory testing (QST), biological samples (blood and skin samples), and Magnetic Resonance Neurography of lumbar nerve roots were collected at baseline. Pain persistence was determined at three and twelve months with the Sciatica Bothersomeness Index (SBI) and a numeric pain rating scale (NRS) as primary outcomes. Recruitment nears completion, with 160 participants enrolled to date. 127 and 96 participants have completed 3 and 12 months follow-up respectively.Overall, 56% of our cohort are female, with a mean age (SD) of 54.14yrs (16.57). Ethnicity data approximates local populations.SBI at baseline was (median [IQR]) 13[10-17], and interim longitudinal data shows stepwise improvement at 3 and 12 months. Baseline ‘average’ pain intensity was 5.56 (2.15) for leg pain, and 4.14(2.82) for low back pain (LBP). Overall, pain scores decreased at 3 and 12 months, with greater reductions in leg pain than LBP at 12 months. However, around 55–80% and 40–65% of people reported persistent pain at 3 and 12 months respectively.ConclusionLeg pain severity was moderate and higher than LBP at baseline. All primary outcome measures demonstrate improvement over time, however 40–65% of patients report persistent pain at 12 months.Conflicts of interestLR: Paid facilitation of post-graduate courses internationally. SK, MT, FP, KM, WS, CP, CR, SC: No conflicts of interest. GC: Editor in Chief of Health Psychology Review. Director of board of directors, MentalCHealth Care setting NoordWestVlaanderen. JF: Copyright holder of ODI (Oswestry Disability Index). Served on a data monitoring committee for a clinical trial of 2 different surgical approaches to cervical disc herniation (FORVAD). Member of HTA Prioritisation Committee B: Inside hospital Care from 2015-February 2019. Member of HTA Interventional Procedures Panel from 2010–2015. Trustee and board member of 3 spine related charities – Back to Back; British Scoliosis Research Foundation and BackCare. Expert instructed by both claimant and defendant solicitors in negligence and person injury cases. GB: Paid consultancy (RNA-seq) with Ivy Farm and Coding.bioABS: Paid post-graduate lecturing internationally. Co-chair NeupSig sciatica working group (unpaid).Sources of fundingThis project is funded by UKRI and Versus Arthritis as part of the UKRI Strategic Priorities Fund (SPF) Advanced Pain Discovery Platform (APDP), a co-funded initiative by UKRI (MRC, BBSRC, ESRC), Versus Arthritis, the Medical Research Foundation and Eli Lilly and Company Ltd (Grant MR/W027003/1). Additional funding has been received from the back to back charity to expand longitudinal components of the study. LR has received support with PhD fees from the CSP charitable trust. ABS is supported by a Wellcome Trust Clinical Career Development Fellowship(222101/Z/20/Z). WS is partly funded through the National Institute for Health and Care Research (NIHR) Biomedical Research Centre at the South London and Maudsley NHS Foundation Trust and King's College London. FP is funded by a Dorothy Hodgkin Career Development Fellowship in Chemistry in association with Somerville College. GB is supported by the Wellcome Trust (223149/Z/21/Z) and Diabetes UK (19/0005984). GC and KRM are partly funded by UKRI and Versus Arthritis as part of the Advanced Pain Discovery Platform (APDP) PAINSTORM (MR/W002388/1). The UKRI and Versus Arhthritis (APDP) are the major funders of FORECAST. All other funders provided either some people support, or funded projects with legacy data that we reuse.

Exploring ethnicity dynamics in Wales: a longitudinal population-scale linked data study and development of a harmonised ethnicity spine

ObjectiveThis study aims to create a national ethnicity spine based on all available ethnicity records in linkable anonymised electronic health record and administrative data sources.DesignA longitudinal study using anonymised individual-level...

Social Determinants of Health and Surgical Desirability of Outcome Ranking in Older Veterans

Evaluating how social determinants of health (SDOH) influence veteran outcomes is crucial, particularly for quality improvement. To measure associations between SDOH, care fragmentation, and surgical outcomes using a Desirability of Outcome Ranking (DOOR). This was a cohort study of US veterans using data from the Veterans Affairs (VA) Surgical Quality Improvement Program (VASQIP; 2013-2019) limited to patients aged 65 years or older with inpatient stays between 2 and 30 days, merged with multiple data sources, including Medicare. Race and ethnicity data were retrieved from VASQIP, Medicare and Medicaid beneficiary summary files, the Veterans Health Administration Corporate Data Warehouse, and the United States Veterans Eligibility Trends and Statistics file. Data were analyzed between September 2023 and February 2024. Living in a highly deprived neighborhood (Area Deprivation Index >85), race and ethnicity used as a social construct, rurality, and care fragmentation (percentage of non-VA care days). DOOR is a composite, patient-centered ranking of 26 outcomes ranging from no complication (1, best) to 90-day mortality or near-death complications (6, worst). A series of proportional odds regressions was used to assess the impact of SDOH and care fragmentation adjusted for clinical risk factors, including presentation acuity (presenting with preoperative acute serious conditions and urgent or emergent surgical procedures). The cohort had 93 644 patients (mean [SD] age, 72.3 [6.2] years; 91 443 [97.6%] male; 74 624 [79.7%] White). Veterans who identified as Black (adjusted odds ratio [aOR], 1.06; 95% CI, 1.02-1.10; P = .048) vs White and veterans with higher care fragmentation (per 20% increase in VA care days relative to all care days: aOR, 1.01; 95% CI, 1.01-1.02; P < .001) were associated with worse (higher) DOOR scores until adjusting for presentation acuity. Living in rural geographic areas was associated with better DOOR scores than living in urban areas (aOR, 0.93; 95% CI, 0.91-0.96; P < .001), and rurality was associated with lower presentation acuity (preoperative acute serious conditions: aOR, 0.88; 95% CI, 0.81-0.95; P = .001). Presentation acuity was higher in veterans identifying as Black, living in deprived neighborhoods, and with increased care fragmentation. Veterans identifying as Black and veterans with greater proportions of non-VA care had worse surgical outcomes. VA programs should direct resources to reduce presentation acuity among Black veterans, incentivize veterans to receive care within the VA where possible, and better coordinate veterans' treatment and records between care sources.

Assessing disparities through missing race and ethnicity data: results from a juvenile arthritis registry.

Ensuring high-quality race and ethnicity data within the electronic health record (EHR) and across linked systems, such as patient registries, is necessary to achieving the goal of inclusion of racial and ethnic minorities in scientific research and detecting disparities associated with race and ethnicity. The project goal was to improve race and ethnicity data completion within the Pediatric Rheumatology Care Outcomes Improvement Network and assess impact of improved data completion on conclusions drawn from the registry. This is a mixed-methods quality improvement study that consisted of five parts, as follows: (1) Identifying baseline missing race and ethnicity data, (2) Surveying current collection and entry, (3) Completing data through audit and feedback cycles, (4) Assessing the impact on outcome measures, and (5) Conducting participant interviews and thematic analysis. Across six participating centers, 29% of the patients were missing data on race and 31% were missing data on ethnicity. Of patients missing data, most patients were missing both race and ethnicity. Rates of missingness varied by data entry method (electronic vs. manual). Recovered data had a higher percentage of patients with Other race or Hispanic/Latino ethnicity compared with patients with non-missing race and ethnicity data at baseline. Black patients had a significantly higher odds ratio of having a clinical juvenile arthritis disease activity score (cJADAS10) of ≥5 at first follow-up compared with White patients. There was no significant change in odds ratio of cJADAS10 ≥5 for race and ethnicity after data completion. Patients missing race and ethnicity were more likely to be missing cJADAS values, which may affect the ability to detect changes in odds ratio of cJADAS ≥5 after completion. About one-third of the patients in a pediatric rheumatology registry were missing race and ethnicity data. After three audit and feedback cycles, centers decreased missing data by 94%, primarily via data recovery from the EHR. In this sample, completion of missing data did not change the findings related to differential outcomes by race. Recovered data were not uniformly distributed compared with those with non-missing race and ethnicity data at baseline, suggesting that differences in outcomes after completing race and ethnicity data may be seen with larger sample sizes.

Ethnicity and Observed Oxygen Saturations, Fraction of Inspired Oxygen, and Clinical Outcomes: A Post-Hoc Analysis of the Oxy-PICU Trial of Conservative Oxygenation.

A conservative oxygenation strategy, targeting peripheral oxygen saturations (Sp o2 ) between 88% and 92% in mechanically ventilated children in PICU, was associated with a shorter duration of organ support and greater survival compared with Sp o2 greater than 94% in our recent Oxy-PICU trial. Sp o2 monitors may overestimate arterial oxygen saturation (Sa o2 ) in patients with higher levels of skin pigmentation compared with those with less skin pigmentation. We investigated if ethnicity was associated with changes in distributions of Sp o2 and F io2 and outcome. Post-hoc analysis of a pragmatic, open-label, multicenter randomized controlled trial. Fifteen PICUs across the United Kingdom and Scotland. Children aged 38 weeks corrected gestational age to 15 years accepted to a participating PICU as an unplanned admission and receiving invasive mechanical ventilation with supplemental oxygen for abnormal gas exchange. Hierarchical regression models for Sp o2 and F io2 , and ordinal models for the primary trial outcome of a composite of the duration of organ support at 30 days and death, were used to examine the effects of ethnicity, accounting for baseline Sp o2 , F io2 , and mean airway pressure and trial allocation. Ethnicity data were available for 1577 of 1986 eligible children, 1408 (89.3%) of which were White, Asian, or Black. Sp o2 and F io2 distributions did not vary according to Black or Asian ethnicity compared with White children. The trial primary outcome measure also did not vary significantly with ethnicity. The point estimate for the treatment effect of conservative oxygenation in Black children was 0.64 (95% CI, 0.33-1.25) compared with 0.84 (0.68-1.04) in the overall trial population. These data do not suggest that the association between improved outcomes and conservative oxygenation strategy in mechanically ventilated children in PICU is modified by ethnicity.

Indigenous governance, ethics and data collection in Australian clinical registries.

To examine Indigenous Governance of Data processes in Australian clinical registries. Audit (via desktop review and interviews) of registries in the Australian Register of Clinical Registries from 17 January 2022 to 30 April 2023. The number of clinical registries collecting ethnicity data, reporting Aboriginal and/or Torres Strait Islander representation on registry governance or steering committees, and reporting human research ethics committee approval. A total of 107 clinical registries were reviewed. Of these registries, 65 (61%) collected ethnicity data; when these were grouped by geographical coverage, those most likely to collect ethnicity data were binational (24/40 [60%]), national (19/26 [73%]) or state based (19/26 [73%]). Of the registries that collected ethnicity data, 29 (45%) classified their ethnicity item as Aboriginal and/or Torres Strait Islander. Only eight clinical registries (7%) reported Aboriginal and/or Torres Strait Islander representation on their governance or steering committees. Human research ethics approval was reported in 94 registries (88%), with only 11 (12%) having Aboriginal human research ethics committee approval. Significant variability is evident in clinical registry recording of Indigenous governance of data, meaning that Aboriginal and Torres Strait Islander communities remain invisible in data which is used to inform policy, clinical models of care, health services and initiatives. Radical change is required to facilitate meaningful change in quality indicators for clinical registries nationally.

Consistency, completeness and external validity of ethnicity recording in NHS primary care records: a cohort study in 25 million patients’ records at source using OpenSAFELY

BackgroundEthnicity is known to be an important correlate of health outcomes, particularly during the COVID-19 pandemic, where some ethnic groups were shown to be at higher risk of infection and adverse outcomes. The recording of patients’ ethnic groups in primary care can support research and efforts to achieve equity in service provision and outcomes; however, the coding of ethnicity is known to present complex challenges. We therefore set out to describe ethnicity coding in detail with a view to supporting the use of this data in a wide range of settings, as part of wider efforts to robustly describe and define methods of using administrative data.MethodsWe describe the completeness and consistency of primary care ethnicity recording in the OpenSAFELY-TPP database, containing linked primary care and hospital records in > 25 million patients in England. We also compared the ethnic breakdown in OpenSAFELY-TPP with that of the 2021 UK census.Results78.2% of patients registered in OpenSAFELY-TPP on 1 January 2022 had their ethnicity recorded in primary care records, rising to 92.5% when supplemented with hospital data. The completeness of ethnicity recording was higher for women than for men. The rate of primary care ethnicity recording ranged from 77% in the South East of England to 82.2% in the West Midlands. Ethnicity recording rates were higher in patients with chronic or other serious health conditions. For each of the five broad ethnicity groups, primary care recorded ethnicity was within 2.9 percentage points of the population rate as recorded in the 2021 Census for England as a whole. For patients with multiple ethnicity records, 98.7% of the latest recorded ethnicities matched the most frequently coded ethnicity. Patients whose latest recorded ethnicity was categorised as Other were most likely to have a discordant ethnicity recording (32.2%).ConclusionsPrimary care ethnicity data in OpenSAFELY is present for over three quarters of all patients, and combined with data from other sources can achieve a high level of completeness. The overall distribution of ethnicities across all English OpenSAFELY-TPP practices was similar to the 2021 Census, with some regional variation. This report identifies the best available codelist for use in OpenSAFELY and similar electronic health record data.

Gaps in Long COVID treatments research: A scoping review

Background Long COVID affects 6 to 10% of people following SARS-CoV-2 infection. It has been documented worldwide, with over 200 symptoms reported. This scoping review assesses the evidence on Long COVID treatments to identify gaps in the evidence-base to inform research prioritisation. Methods We searched four databases (MEDLINE, Embase, Cochrane’s Trial register, Epistemonikos) supplemented by a grey literature search up to April 2023. Two reviewers screened articles and extracted data. Data were analysed using a thematic approach. Results Of 3675 records identified, 26 studies were included. Most were in high-income countries (92%), with two in upper-middle-income countries (8%). None reported inclusion of children, nor pregnant women and only 37.5% included adults over 64 years. Five (20.8%) presented ethnicity data, of these 92.9% of participants were of white ethnicity. Treatments included nutritional supplements (46%), conventional medicines (38%), hyperbaric medicine (8%), COVID-19 vaccination (4%) and complementary, alternative medicine (4%). Conclusion This scoping review highlights that more than four years after the start of the pandemic, research gaps remain for Long COVID treatments. There is a lack of research in low-income countries, despite trials being best placed locally to reflect different population demographics. There is a lack of inclusion of population sub-groups, particularly children, pregnant women and ethnic minority groups. Inclusion of these groups in future research is important given they may be at a higher risk of adverse outcomes of COVID-19, and a lack of appropriate treatments for Long COVID may contribute to the widening of health inequalities.

Medication development for AUD: A systematic review of clinical trial methodology

Refining clinical trial methodology has become increasingly important as study design is shown to influence treatment efficacy. To maximize the efficiency of randomized clinical trials (RCTs), researchers aim to establish standardized practices. The goal of this systematic review is to describe methodological practices of clinical trials for alcohol use disorder (AUD) over the past 40 years. To achieve this goal, a PubMed search was conducted in April 2023 for RCTs on AUD medications published between July 2018 through April 2023. Resulting studies were combined with a previous search from 1985 through 2018. Inclusion criteria for the RCT studies were: (1) a randomized controlled trial, (2) double or single blinded, (3) placebo or active control condition, (4) alcohol use as the primary endpoint, (5) 4 or more weeks of treatment, and (6) 12 or more weeks of follow-up. In total, methodological data from 139 RCTs representing 19 medications and spanning the past four decades were summarized. Results indicated that the most common medications tested were naltrexone (k = 42), acamprosate (k = 24), and baclofen (k = 11). On average, participants were 74% male and consumed 226 drinks per month pre-randomization. The median length of treatment was 12 weeks (IQR = 12–16; min = 4 max = 52) and the median follow-up duration was 12.5 weeks (IQR: 12–26; min = 7 max = 104). There were two broad domains of outcomes (i.e., abstinence and heavy drinking), with most studies featuring outcomes from both domains (k = 87; 63%). Reporting practices were summarized by decade, revealing an increased enrollment of females, better reporting of race and ethnicity data, and less studies requiring pre-trial abstinence. This review summarizes the current state of the literature on randomized clinical trials for AUD including effect sizes for individual studies and summaries of key methodological features across this representative set of clinical trials.