US Health Care Spending by Race and Ethnicity, 2002-2016.

Importance: Measuring health care spending by race and ethnicity is important for understanding patterns in utilization and treatment. Objective: To estimate, identify, and account for differences in health care spending by race and ethnicity from 2002 through 2016 in the US. Design, Setting, and Participants: This exploratory study included data from 7.3 million health system visits, admissions, or prescriptions captured in the Medical Expenditure Panel Survey (2002-2016) and the Medicare Current Beneficiary Survey (2002-2012), which were combined with the insured population and notified case estimates from the National Health Interview Survey (2002; 2016) and health care spending estimates from the Disease Expenditure project (1996-2016). Exposure: Six mutually exclusive self-reported race and ethnicity groups. Main Outcomes and Measures: Total and age-standardized health care spending per person by race and ethnicity for each year from 2002 through 2016 by type of care. Health care spending per notified case by race and ethnicity for key diseases in 2016. Differences in health care spending across race and ethnicity groups were decomposed into differences in utilization rate vs differences in price and intensity of care. Results: In 2016, an estimated $2.4 trillion (95% uncertainty interval [UI], $2.4 trillion-$2.4 trillion) was spent on health care across the 6 types of care included in this study. The estimated age-standardized total health care spending per person in 2016 was $7649 (95% UI, $6129-$8814) for American Indian and Alaska Native (non-Hispanic) individuals; $4692 (95% UI, $4068-$5202) for Asian, Native Hawaiian, and Pacific Islander (non-Hispanic) individuals; $7361 (95% UI, $6917-$7797) for Black (non-Hispanic) individuals; $6025 (95% UI, $5703-$6373) for Hispanic individuals; $9276 (95% UI, $8066-$10 601) for individuals categorized as multiple races (non-Hispanic); and $8141 (95% UI, $8038-$8258) for White (non-Hispanic) individuals, who accounted for an estimated 72% (95% UI, 71%-73%) of health care spending. After adjusting for population size and age, White individuals received an estimated 15% (95% UI, 13%-17%; P < .001) more spending on ambulatory care than the all-population mean. Black (non-Hispanic) individuals received an estimated 26% (95% UI, 19%-32%; P < .001) less spending than the all-population mean on ambulatory care but received 19% (95% UI, 3%-32%; P = .02) more on inpatient and 12% (95% UI, 4%-24%; P = .04) more on emergency department care. Hispanic individuals received an estimated 33% (95% UI, 26%-37%; P < .001) less spending per person on ambulatory care than the all-population mean. Asian, Native Hawaiian, and Pacific Islander (non-Hispanic) individuals received less spending than the all-population mean on all types of care except dental (all P < .001), while American Indian and Alaska Native (non-Hispanic) individuals had more spending on emergency department care than the all-population mean (estimated 90% more; 95% UI, 11%-165%; P = .04), and multiple-race (non-Hispanic) individuals had more spending on emergency department care than the all-population mean (estimated 40% more; 95% UI, 19%-63%; P = .006). All 18 of the statistically significant race and ethnicity spending differences by type of care corresponded with differences in utilization. These differences persisted when controlling for underlying disease burden. Conclusions and Relevance: In the US from 2002 through 2016, health care spending varied by race and ethnicity across different types of care even after adjusting for age and health conditions. Further research is needed to determine current health care spending by race and ethnicity, including spending related to the COVID-19 pandemic.

Comparison of bench test results measuring the accuracy of peak flow meters.

BACKGROUND: The study evaluates and compares the accuracy of nine peak flow meters ("PFMs") and spirometers that are currently available in Europe and have Conformité Européene ("CE") marking. The CE marking is a manufacturer's declaration that their product complies with European health regulations and it is a requirement for marketing medical devices in Europe. METHODS: The nine devices were selected as they all had received or were in the process of receiving CE approval in Europe and were readily obtainable. The devices were bench tested following the ISO 23747:2015 accuracy guidelines for medical devices measuring peak flow. All standards, including accuracy, from these guidelines must be met to obtain CE marking. This study was performed with a certified piston pump testing apparatus. The apparatus chosen was the pulmonary waveform generator manufactured by Piston Medical Ltd. Using predefined flow (time) and volume (time) waveforms, peak flow meters and spirometers were tested for validation and calibration. Three CE guideline tests were utilised, and standards require that all three tests are passed for the device to obtain certification. RESULTS: Of the nine devices that were tested, two passed and seven failed. The devices that passed the tests were the Smart Peak Flow® and the Mini Wright®. CONCLUSIONS: A high percentage of devices failed accuracy testing in this study. This is a concern as the CE marking is a manufacturer's certification documenting the accuracy, reliability and safety of devices. Of the seven devices that failed all have the CE marking. All tested devices are on the market in Europe based upon studies conducted by each of the manufacturers. The data used to obtain CE certification of these devices, however, are not in the public domain.

Silk garments plus standard care compared with standard care for treating eczema in children: A randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial).

BACKGROUND: The role of clothing in the management of eczema (also called atopic dermatitis or atopic eczema) is poorly understood. This trial evaluated the effectiveness and cost-effectiveness of silk garments (in addition to standard care) for the management of eczema in children with moderate to severe disease. METHODS AND FINDINGS: This was a parallel-group, randomised, controlled, observer-blind trial. Children aged 1 to 15 y with moderate to severe eczema were recruited from secondary care and the community at five UK medical centres. Participants were allocated using online randomisation (1:1) to standard care or to standard care plus silk garments, stratified by age and recruiting centre. Silk garments were worn for 6 mo. Primary outcome (eczema severity) was assessed at baseline, 2, 4, and 6 mo, by nurses blinded to treatment allocation, using the Eczema Area and Severity Index (EASI), which was log-transformed for analysis (intention-to-treat analysis). A safety outcome was number of skin infections. Three hundred children were randomised (26 November 2013 to 5 May 2015): 42% girls, 79% white, mean age 5 y. Primary analysis included 282/300 (94%) children (n = 141 in each group). The garments were worn more often at night than in the day (median of 81% of nights [25th to 75th centile 57% to 96%] and 34% of days [25th to 75th centile 10% to 76%]). Geometric mean EASI scores at baseline, 2, 4, and 6 mo were, respectively, 9.2, 6.4, 5.8, and 5.4 for silk clothing and 8.4, 6.6, 6.0, and 5.4 for standard care. There was no evidence of any difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age, and centre: adjusted ratio of geometric means 0.95, 95% CI 0.85 to 1.07, (p = 0.43). This confidence interval is equivalent to a difference of -1.5 to 0.5 in the original EASI units, which is not clinically important. Skin infections occurred in 36/142 (25%) and 39/141 (28%) of children in the silk clothing and standard care groups, respectively. Even if the small observed treatment effect was genuine, the incremental cost per quality-adjusted life year was £56,811 in the base case analysis from a National Health Service perspective, suggesting that silk garments are unlikely to be cost-effective using currently accepted thresholds. The main limitation of the study is that use of an objective primary outcome, whilst minimising detection bias, may have underestimated treatment effects. CONCLUSIONS: Silk clothing is unlikely to provide additional benefit over standard care in children with moderate to severe eczema. TRIAL REGISTRATION: Current Controlled Trials ISRCTN77261365.

Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial.

BACKGROUND: Atopic eczema (AE) is a chronic, itchy, inflammatory skin condition that affects the quality of life of children and their families. The role of specialist clothing in the management of AE is poorly understood. OBJECTIVES: To assess the effectiveness and cost-effectiveness of silk garments for the management of AE in children with moderate to severe disease. DESIGN: Parallel-group, observer-blind, randomised controlled trial of 6 months' duration, followed by a 2-month observational period. A nested qualitative study evaluated the beliefs of trial participants, health-care professionals and health-care commissioners about the use of silk garments for AE. SETTING: Secondary care and the community in five UK centres. PARTICIPANTS: Children aged 1-15 years with moderate or severe AE. INTERVENTIONS: Participants were randomised (1 : 1 using online randomisation) to standard care or standard care plus 100% silk garments made from antimicrobially protected knitted sericin-free silk [DermaSilkTM (AlPreTec Srl, San Donà di Piave, Italy) or DreamSkinTM (DreamSkin Health Ltd, Hatfield, UK)]. Three sets of garments were supplied per participant, to be worn for up to 6 months (day and night). At 6 months the standard care group received the garments to use for the remaining 2-month observational period. MAIN OUTCOME MEASURES: Primary outcome - AE severity using the Eczema Area and Severity Index (EASI) assessed at 2, 4 and 6 months, by nurses blinded to treatment allocation. EASI scores were log-transformed for analysis. Secondary outcomes - patient-reported eczema symptoms (Patient Oriented Eczema Measure); global assessment of severity (Investigator Global Assessment); quality of life of the child (Atopic Dermatitis Quality of Life, Child Health Utility - 9 Dimensions), family (Dermatitis Family Impact Questionnaire) and main carer (EuroQoL-5 Dimensions-3 Levels); use of standard eczema treatments (e.g. emollients, topical corticosteroids); and cost-effectiveness. The acceptability and durability of the clothing, and adherence to wearing the garments, were assessed by parental/carer self-report. Safety outcomes - number of skin infections and hospitalisations for AE. RESULTS: A total of 300 children were randomised (26 November 2013 to 5 May 2015): 42% female, 79% white, mean age 5 years. The primary analysis included 282 out of 300 (94%) children (n = 141 in each group). Garments were worn for at least 50% of the time by 82% of participants. Geometric mean EASI scores at baseline, 2, 4 and 6 months were 8.4, 6.6, 6.0, 5.4 for standard care and 9.2, 6.4, 5.8, 5.4 for silk clothing, respectively. There was no evidence of difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age and centre (ratio of geometric means 0.95, 95% confidence interval 0.85 to 1.07; p = 0.43). This confidence interval is equivalent to a difference of -1.5 to 0.5 in the original EASI scale units. Skin infections occurred in 39 out of 141 (28%) and 36 out of 142 (25%) participants for standard care and silk clothing groups, respectively. The incremental cost per QALY of silk garments for children with moderate to severe eczema was £56,811 from a NHS perspective in the base case. Sensitivity analyses supported the finding that silk garments do not appear to be cost-effective within currently accepted thresholds. LIMITATIONS: Knowledge of treatment allocation may have affected behaviour and outcome reporting for some of the patient-reported outcomes. CONCLUSIONS: The addition of silk garments to standard AE care is unlikely to improve AE severity, or to be cost-effective compared with standard care alone, for children with moderate or severe AE. This trial adds to the evidence base to guide clinical decision-making. FUTURE WORK: Non-pharmacological interventions for the management of AE remain a research priority among patients. TRIAL REGISTRATION: Current Controlled Trials ISRCTN77261365. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 16. See the NIHR Journals Library website for further project information.

How many paediatric referrals to an allergist could be managed by a general practitioner with special interest?

BACKGROUND: The concept of a general practitioner with special interest (GPwSI) was first proposed in the 2000 National Health Service Plan, as a way of providing specialized treatment closer to the patient's home and reducing hospital waiting times. Given the patchy and inadequate provision of paediatric allergy services in the UK, the introduction of GPwSIs might reduce pressure on existing specialist services. METHODS: A total of 100 consecutive referrals to a specialist paediatric allergy clinic were reviewed to assess what proportion could be managed by a GPwSI allergy service with a predefined range of facilities and expertise (accurate diagnosis and management of allergy; skin prick testing; provision of allergen avoidance advice; ability to assess suitability for desensitization). Each referral was reviewed independently by three allergy specialists. Cases were initially judged on the referral letter and then, to determine whether appropriate triage decisions could be made prospectively, cases were re-assessed with information summarized in the clinic letter. The proportion of referrals suitable for a GPwSI was calculated and their characteristics identified. RESULTS: At least 42% and up to 75% were suitable for management by a GPwSI in allergy based on unanimous and majority agreement, respectively. The appropriateness of 79% referrals could be identified based on the information in the referral letter. A total of 19% referrals were unsuitable for a GPwSI service because of complex or multisystem disease, need for specialist knowledge or facilities or patient's young age. CONCLUSIONS: At least two-fifths of paediatric allergy referrals to our hospital-based service could be dealt with in a GPwSI clinic, thereby diversifying the patient pathway, allowing specialist services to focus on complex cases and reducing waiting times for appointments.

A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial.

BACKGROUND: Eczema is a chronic, itchy skin condition that can have a large impact on the quality of life of patients and their families. People with eczema are often keen to try out non-pharmacological therapies like silk therapeutic garments that could reduce itching or the damage caused by scratching. However, the effectiveness and cost-effectiveness of these garments in the management of eczema has yet to be proven. The CLOTHES Trial will test the hypothesis that 'silk therapeutic garments plus standard eczema care' is superior to 'standard care alone' for children with moderate to severe eczema. METHODS/DESIGN: Parallel group, observer-blind, pragmatic, multi-centre randomised controlled trial of 6 months' duration. Three hundred children aged 1 to 15 years with moderate to severe eczema will be randomised (1:1) to receive silk therapeutic garments plus standard eczema care, or standard eczema care alone. Primary outcome is eczema severity, as assessed by trained and blinded investigators at 2, 4 and 6 months (using the Eczema Area and Severity Index (EASI)). Secondary outcomes include: patient-reported eczema symptoms (collected weekly for 6 months to capture long-term control); global assessment of severity; quality of life of the child, family and main carer; use of standard eczema treatments (emollients, corticosteroids applied topically, calcineurin inhibitors applied topically and wet wraps); frequency of infections; and cost-effectiveness. The acceptability and durability of the clothing will also be assessed, as will adherence to wearing the garments. A nested qualitative study will assess the views of a subset of children wearing the garments and their parents, and those of healthcare providers and commissioners. Randomisation uses a computer-generated sequence of permuted blocks of randomly varying size, stratified by recruiting hospital and child's age (< 2 years; 2 to 5 years; > 5 years), and concealed using a secure web-based system. The sequence of treatment allocations will remain concealed until randomisation and data collection are complete. Recruitment is taking place from November 2013 to May 2015, and the trial will be completed in 2016. Full details of results will be published in the National Institute for Health Research Journal series. TRIAL REGISTRATION: Current Controlled Trials ISRCTN77261365 (registered 11 November 2013).

Long-term use of a 4% sodium cromoglicate cutaneous emulsion in the treatment of moderate to severe atopic dermatitis in children.

INTRODUCTION: Sodium cromoglicate (SCG), a chromone with anti-inflammatory, anti-itch and anti-allergic properties. We report a long-term study of a 4% aqueous solution of SCG in children with moderate to severe atopic dermatitis (AD). MATERIALS AND METHODS: Children aged 1 to 12 years with AD were entered into a 12-week randomised clinical trial (RCT), followed by 12 months open treatment with known 4% SCG emulsion (Altocrom®). Primary endpoint was change in SCORAD score. Secondary endpoints included symptom severity, Quality of Life, concomitant treatment usage, global assessments. RESULTS: One hundred and seventy-seven subjects entered, 118 treated with 4% SCG emulsion and 59 with vehicle: 128 completed 12 months in open study. SCORAD score reduced during RCT by -15.3 (-33%) on 4% SCG emulsion and -18.0 (-39%) on vehicle: p = 0.2331. After 12 months reduction was 56%. No secondary endpoint showed differences between treatments during RCT. Thirty-two subjects reported treatment related events during RCT and open trial. Eleven (7%) reported application site discomfort. Most were reported as mild and most resolved without intervention and the study drug was stopped in one case only. CONCLUSIONS: SCG 4% cutaneous emulsion was well tolerated in children treated for 15 months.

A randomised, controlled trial of a 4% cutaneous emulsion of sodium cromoglicate in treatment of atopic dermatitis in children.

INTRODUCTION: Atopic dermatitis (AD) is a chronic inflammatory skin disease. Sodium cromoglicate (SCG) is a chromone with anti-inflammatory, anti-itch and anti-allergic activity. This trial is a 12-week comparison (RCT) of a 4% SCG cutaneous emulsion with its vehicle in AD. MATERIALS AND METHODS: 208 children aged 2-12 years participated, 104 in each group. The primary endpoint was change in SCORAD score. Secondary endpoints included SASSAD score, topical steroid usage and global assessments. RESULTS: SCORAD was reduced by 28% (SCG group) and by 19% (vehicle): difference was statistically significant (p = 0.03) after 8 weeks and nearly significant (p = 0.09) after 12. A similar result occurred in SASSAD (p = 0.001 at 8 weeks). In subjects without major protocol deviations (SCG-64, vehicle-63), difference in SCORAD remained significant at 12 weeks (p = 0.04). Weight of topical steroids reduced in both groups: -0.60 ± 1.3 g/day (35%), SCG and -0.05 ± 1.1 g/day vehicle (p = 0.04). Treatment success, defined as investigator global opinion graded very or moderately effective, was significantly more frequent in SCG group (p = 0.025). Application site discomfort reported by 12.5% of subjects in SCG group and 16.5% in vehicle group. CONCLUSIONS: SCG 4% cutaneous emulsion provides an effective, well-tolerated, steroid-sparing treatment for AD in children.