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Anterior Gastropexy for Paraesophageal Hernia Repair: A Randomized Clinical Trial

JAMA Surg. 2024 Dec 23. doi: 10.1001/jamasurg.2024.5788. Online ahead of print.

ABSTRACT

IMPORTANCE: Paraesophageal hernias can cause severe limitations in quality of life and life-threatening complications. Even though minimally invasive paraesophageal hernia repair (MIS-PEHR) is safe and effective, anatomic recurrence rates remain notoriously high. Retrospective data suggest that suturing the stomach to the anterior abdominal wall after repair-an anterior gastropexy-may reduce recurrence, but this adjunct is currently not the standard of care.

OBJECTIVE: To determine whether anterior gastropexy reduces 1-year recurrence after MIS-PEHR.

DESIGN, SETTING, AND PARTICIPANTS: This registry-based randomized clinical trial was conducted by 10 surgeons at 3 academic hospitals within the Cleveland Clinic Enterprise. Between June 26, 2019, and July 24, 2023, 348 patients were assessed for eligibility, and 240 patients were enrolled and randomized. Statistical analysis was performed from January to March 2024.

INTERVENTION: Enrolled patients were randomized to and received either an anterior gastropexy (n = 119) or no anterior gastropexy (n = 121).

MAIN OUTCOME: The primary outcome was recurrence as determined by reherniation of the stomach greater than 2 cm above the diaphragm on routine imaging at 1 year or reoperation. Secondary outcomes included quality of life as measured by the Gastroesophageal Reflux Health-Related Quality of Life survey, additional foregut symptom questionnaire, and patient satisfaction at 30 days and 1 year.

RESULTS: A total of 240 patients were randomized to either anterior gastropexy (n = 119; 104 [97%] women; median [IQR] age, 70 [64-75] years) or no anterior gastropexy (n = 121; 97 [80%] women; median [IQR] age, 68 [62-73] years) at the end of their MIS-PEHR. At 1 year, 188 patients (78%) had completed follow-up. By intention-to-treat analysis, 1-year recurrence was significantly lower in patients who received an anterior gastropexy (15% vs 36%; risk difference, 0.21 [95% CI, 0.09-0.33]), which remained significant after risk-adjusted regression analysis (hazard ratio, 0.38 [95% CI, 0.23-0.60]). Of 13 reoperations (5.4%) for recurrence in the first year, 3 (2.5%) were in the anterior gastropexy group and 10 (8.2%) were in the no-gastropexy group (P = .052). Two patients (1.7%) had their anterior gastropexy sutures removed for pain. There were no significant differences in quality-of-life outcomes at 30 days and 1 year between treatment groups.

CONCLUSIONS AND RELEVANCE: This randomized clinical trial found that the addition of an anterior gastropexy to MIS-PEHR is superior to no gastropexy in regard to reducing 1-year paraesophageal hernia recurrence. These results suggest that an anterior gastropexy should be routinely used in the context of minimally invasive paraesophageal hernia repair.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04007952.

PMID:39714889 | DOI:10.1001/jamasurg.2024.5788

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Home Visits and the Use of Routine and Emergency Postpartum Care Among Low-Income People: A Secondary Analysis of a Randomized Clinical Trial

JAMA Netw Open. 2024 Dec 2;7(12):e2451605. doi: 10.1001/jamanetworkopen.2024.51605.

ABSTRACT

IMPORTANCE: Access to appropriate postpartum care is essential for improving maternal health outcomes and promoting maternal health equity.

OBJECTIVE: To analyze the impact of the Nurse-Family Partnership (NFP) home visiting program on use of routine and emergency postpartum care.

DESIGN, SETTING, AND PARTICIPANTS: This study was a secondary analysis of a randomized clinical trial that enrolled eligible participants between 2016 and 2020 to receive NFP or usual care from a South Carolina Medicaid program. Participants were nulliparous pregnant individuals at less than 28 weeks’ gestation at enrollment who were enrolled in Medicaid during pregnancy or delivery. Analysis was performed February 2, 2023, to July 16, 2024.

INTERVENTION: Participants were enrolled in a 2:1 ratio to receive NFP, an established model of nurse home visiting, or usual care. NFP visits are conducted prenatally and for up to 2 years post partum.

MAIN OUTCOMES AND MEASURES: This study assessed one of the trial’s preregistered secondary outcomes: attendance at a routine postpartum health care visit before 12 weeks post partum. Other exploratory outcomes included outpatient care use, hospitalization, and emergent, nonemergent, and any use of emergency department (ED) health services at 12 weeks and 1 year post partum. Subgroup analyses examined individuals who underwent cesarean delivery, had chronic disease, experienced pregnancy complications, reported non-Hispanic Black race and ethnicity, were socially vulnerable, or were unaffected by COVID-19.

RESULTS: Among 5670 participants enrolled, 4877 were analyzed (median [IQR] age, 21 [19-25] years), including 3261 who received NFP and 1616 who received usual care. By race and ethnicity, the sample included 259 Hispanic individuals (5.7%); 56 non-Hispanic Asian, Indigenous, or Native Hawaiian and Pacific Islander individuals (1.2%); 2535 non-Hispanic Black individuals (55.4%); 1587 non-Hispanic White individuals (34.7%); and 141 individuals (3.1%) with more than 1 race reported (and non-Hispanic ethnicity). There was no significant difference in attendance of routine postpartum visit at 12 weeks between NFP and usual care groups (63.8% vs 64.2%; adjusted difference [AD] -0.3 [95% CI, -3.2 to 2.5] percentage points). In exploratory analyses, the NFP group was less likely to have a visit to the ED without admission (AD, -2.5 [95% CI, -4.8 to -0.1] percentage points) in the first 12 weeks post partum. Other outcomes, including hospitalizations, outpatient visits, and emergent and nonemergent ED visits, were not different between intervention and control groups. There were also no statistically significant differences within subgroups.

CONCLUSIONS AND RELEVANCE: In this secondary analysis of a randomized clinical trial of nulliparous pregnant individuals with low income, nurse home visiting did not increase use of routine postpartum care in the immediate or extended postpartum periods, even among those with greater health challenges. Nurse home visiting was associated with reduced ED use. More research is needed on how to improve continuity of perinatal care for low-income populations.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03360539.

PMID:39714843 | DOI:10.1001/jamanetworkopen.2024.51605

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Dental Clinic Deserts in the US: Spatial Accessibility Analysis

JAMA Netw Open. 2024 Dec 2;7(12):e2451625. doi: 10.1001/jamanetworkopen.2024.51625.

ABSTRACT

IMPORTANCE: Little is known about the spatial accessibility to dental clinics across the US.

OBJECTIVE: To map the spatial accessibility of dental clinics nationally and to examine the characteristics of counties and US Census block groups with dental care shortage areas.

DESIGN, SETTING, AND PARTICIPANTS: Cross-sectional study of US dental clinics in 2023 using data from the IQVIA national practitioners’ database, which includes 205 762 active dentists. Data were analyzed from November 2023 to April 2024.

EXPOSURES: Socioeconomic characteristics of block groups and counties including rurality, area deprivation, racial and ethnic segregation, and uninsured population.

MAIN OUTCOMES AND MEASURES: Enhanced 2-step floating catchment area method with a 30-minute drive time impedance was used to calculate the accessibility score to dental clinics at the block group level. The outcomes were dental clinic shortage areas and inequality in access to dental clinics.

RESULTS: Nearly 1.7 million people in the US (0.5%) lacked access to dental clinics within a 30-minute drive. This included 0.9 million male (52.2%), 1.2 million White (71.0%), 52 636 Black (3.0%), and 176 885 Hispanic (10.2%) individuals. Approximately 24.7 million people (7.5%) lived in dental care shortage areas (defined as <1 dentist per 5000 population). There was a significant difference in spatial accessibility scores between rural and urban areas, with 1 dentist for every 3850 people in rural areas and 1 dentist for every 1470 people in urban areas. Additionally, there were 387 counties with significant disparities in access to dental clinics. Rural block groups (23.9 percentage points [pp]; 95% CI, 23.6-24.3), block groups with higher levels of Black (1.5 pp; 95% CI, 1.3-1.7) and Hispanic (4.5 pp; 95% CI, 4.3-4.8) segregation, and block groups with the highest levels of area deprivation (5.5 pp; 95% CI, 5.1-5.9) were more likely to experience dental care shortages compared with urban block groups and those with lower levels of segregation and area deprivation. Moreover, rural counties (11.3 pp; 95% CI, 8.9-13.7), counties with a high uninsured population (3.0 pp; 95% CI, 1.5-4.4), and counties with high levels of deprivation (5.8 pp; 95% CI, 2.1-9.5) were more likely to have inequality in access to dental clinics.

CONCLUSIONS AND RELEVANCE: In this cross-sectional study of US dental clinics, there was geographic shortage and maldistribution of the dental workforce. These findings can support dental workforce planning efforts at the federal and state levels to encourage dentists to practice in underserved areas to reduce disparities in access to dental care.

PMID:39714842 | DOI:10.1001/jamanetworkopen.2024.51625

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Social Determinants of Health, Blood Pressure Classification, and Incident Stroke Among Chinese Adults

JAMA Netw Open. 2024 Dec 2;7(12):e2451844. doi: 10.1001/jamanetworkopen.2024.51844.

ABSTRACT

IMPORTANCE: Although cumulative evidence suggests that higher blood pressure (BP) and a greater burden of social determinants of health (SDOH) are associated with an increased risk of stroke, few studies have examined whether SDOH burden modifies the association between BP and stroke risk.

OBJECTIVE: To evaluate whether the association between BP classification and stroke risk differs by SDOH burden among Chinese adults.

DESIGN, SETTING, AND PARTICIPANTS: In this cohort study, analyses were conducted among 90 850 participants in the prospective subcohort of the China Patient-Centered Evaluative Assessment of Cardiac Events Million Persons Project, with recruitment from January 1, 2016, to December 31, 2020. Participants without cardiovascular diseases and with complete data were included and followed up for stroke events until June 30, 2023.

EXPOSURES: Social determinants of health burden was defined using 5 components: educational attainment, economic stability, health care access, social support, and urban vs rural residence. Blood pressure was categorized according to the 2017 American College of Cardiology/American Heart Association BP guideline.

MAIN OUTCOMES AND MEASURES: Multivariable Cox proportional hazards regression was used to estimate hazard ratios (HRs) and 95% CIs for associations of BP classification with incident stroke stratified by SDOH burden groups.

RESULTS: The study included 90 850 participants (median age, 54.0 years [IQR, 46.0-62.0 years]; 55 390 women [61.0%]). During a median follow-up of 5.0 years (IQR, 4.1-5.8 years), 4408 incident stroke events were recorded. Compared with normal BP, elevated BP (HR, 1.33 [95% CI, 1.17-1.52]), stage 1 hypertension (HR, 1.60 [95% CI, 1.43-1.78]), and stage 2 hypertension (HR, 1.79 [95% CI, 1.61-2.00]) were associated with stroke among participants with high SDOH burden, while only stage 2 hypertension (HR, 1.52 [95% CI, 1.20-1.93]) was associated with stroke among those with low SDOH burden, with a significant multiplicative interaction of SDOH burden and BP classification (P = .03). Participants with high SDOH burden and stage 2 hypertension had the highest risk of stroke compared with participants with low SDOH burden and normal BP (HR, 2.13 [95% CI, 1.75-2.60]).

CONCLUSIONS AND RELEVANCE: This study suggests that higher BP levels, even at lower stages of hypertension, pose a greater stroke risk for individuals with high SDOH burden. Early surveillance and intervention for high BP should be emphasized in socioeconomically disadvantaged populations.

PMID:39714839 | DOI:10.1001/jamanetworkopen.2024.51844

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Within-Hospital Price Gaps Across National Insurers

JAMA Netw Open. 2024 Dec 2;7(12):e2451941. doi: 10.1001/jamanetworkopen.2024.51941.

ABSTRACT

IMPORTANCE: Commercial prices for hospital care are high and vary widely in the US. Employers and state policymakers are exploring reference-based pricing (RBP) to set their payment rates as multiples of Medicare prices; understanding the range of commercial price variation within a hospital is important for calculating the appropriate price targets that are effectively low to generate savings but also feasible and viable to local hospital markets.

OBJECTIVE: To examine within-hospital maximum-to-minimum commercial hospital price gaps negotiated by 5 national insurers and estimate plan savings if the minimum prices within each hospital are used as new payment level.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used the insurer-disclosed Transparency in Coverage data as of March 2024. There were 40 382 commercial hospital facility prices extracted for 10 common services negotiated by CVS Health, Elevance Health, Blue Cross Blue Shield, Cigna, and United Healthcare, measured at the hospital-service-insurer level relative to the 2024 Medicare prices. For each hospital-service pair, the minimum, enrollment-weighted mean, and maximum prices were calculated, as well as the maximum-to-minimum price gaps. Plan savings were then estimated using the minimum within-hospital prices as the new payment levels.

EXPOSURE: Insurer price disclosure under federal Transparency in Coverage rule.

MAIN OUTCOMES AND MEASURES: Maximum-to-minimum commercial price gaps and estimated savings if using the minimum prices at hospital-service level.

RESULTS: Among 40 382 commercial hospital prices negotiated by 5 national insurers, the national means of minimum prices were 168% (95% CI, 167%-169%) of Medicare rates for inpatient services and 220% (95% CI, 215%-226%) of Medicare rates for outpatient services. National mean minimum-to-maximum price gaps were 86% (95% CI, 85%-87%) and 222% (95% CI, 215%-229%) of Medicare rates for inpatient and outpatient services, respectively. If using the minimum within-hospital prices, compared with current prices, payers could save 21% (95% CI, 20%-21%) for inpatient services and 29% (95% CI, 28%-30%) for outpatient services.

CONCLUSIONS AND RELEVANCE: In this cross-sectional study, commercial prices across different national insurers varied substantially for the same hospital and service. These results suggest that employers and policymakers interested in RBP benchmarking may use the lowest prices among major insurers in their local hospital market as references to negotiate lower prices.

PMID:39714838 | DOI:10.1001/jamanetworkopen.2024.51941

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Identification and Health Risks of an Emerging Means of Drug Use in Correctional Facilities

JAMA Netw Open. 2024 Dec 2;7(12):e2451951. doi: 10.1001/jamanetworkopen.2024.51951.

ABSTRACT

IMPORTANCE: Recreational use of drug-soaked paper strips (hereafter, strips) in correctional facilities poses a major public health risk owing to the diverse and potentially severe toxic effects of the substances they contain. Understanding the clinical manifestations and outcomes of exposure to these strips is important for developing effective management and prevention strategies.

OBJECTIVE: To characterize the clinical manifestations, management, and outcomes of intoxication from strips in a correctional facility population, and to identify the specific substances present in these strips.

DESIGN, SETTING, AND PARTICIPANTS: This is a case series with a retrospective medical record review and biospecimen analysis. Participants were incarcerated individuals from a county jail who presented to the emergency department of an urban hospital in Atlanta, Georgia, with suspected strip exposure between August 1, 2022, and November 1, 2023. Strip samples were tested using gas chromatography-mass spectrometry and liquid chromatography quadrupole time-of-flight mass spectrometry (LC-QTOF-MS), and serum samples were analyzed via LC-QTOF-MS.

EXPOSURES: All patients had suspected exposure to strips, thought to contain opioids, synthetic cannabinoid receptor agonists (SCRAs), and other novel synthetic drugs.

MAIN OUTCOMES AND MEASURES: The primary outcomes were clinical manifestations of strip exposure, including clinical signs and symptoms, vital sign derangements, laboratory and imaging findings, treatments administered, and patient outcomes.

RESULTS: There were 18 patients (all male; median [IQR] age, 27.5 [18.0-45.0] years) in total. Bradycardia (11 patients [61%]) and central nervous system depression (17 patients [94%]) were the most common clinical findings. Other symptoms included agitation (6 patients [33%]) and seizures (4 patients [22%]). Treatment primarily involved supportive care, with 2 patients requiring intubation. One patient died as a result of hypoxic ischemic encephalopathy. Analysis of strip samples revealed the presence of synthetic cannabinoids and benzimidazole opioids, but no household cleaners or pesticides. Serum testing confirmed the presence of SCRAs and their metabolites.

CONCLUSIONS AND RELEVANCE: In this case series study of strip intoxication among incarcerated individuals, severe and variable clinical manifestations were observed, predominantly associated with their SCRA content. Bradycardia in the context of major central nervous system depression was an indicator of severe SCRA toxic effects. Further research is needed to better understand strip use and to develop effective prevention and treatment strategies.

PMID:39714837 | DOI:10.1001/jamanetworkopen.2024.51951

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Outpatient Dermatology Productivity Measures by Patient Race, Sex, and Age

JAMA Dermatol. 2024 Dec 23. doi: 10.1001/jamadermatol.2024.5286. Online ahead of print.

ABSTRACT

IMPORTANCE: Clinical productivity measures may incentivize clinical care to specific patient populations and thus perpetuate inequitable care. Before the 2021 Medicare physician fee schedule changes, outpatient dermatology encounters for patients who were younger, female, and races other than White systematically generated fewer work relative value units (wRVUs).

OBJECTIVE: To examine the association of patient race, age, and sex with wRVUs generated by outpatient dermatology encounters after 2021.

DESIGN, SETTING, AND PARTICIPANTS: This multi-institutional cross-sectional study evaluated demographic and billing data for outpatient dermatology encounters across 3 academic dermatology practices. The study compared wRVUs generated by outpatient general dermatology encounters in 6-month periods before and after the 2021 fee schedule updates (March 1 to August 31, 2019, and March 1 to August 31, 2021). Eligibility required an age of 18 years or older and available age, race, and sex data. Data analysis was performed from September 2022 to March 2024.

MAIN OUTCOMES AND MEASURES: The primary outcome was wRVUs generated per encounter.

RESULTS: This study included 89 656 encounters (47 607 before the 2021 Medicare physician fee schedule update and 42 049 after the update). Across all encounters, the mean (SD) patient age was 56.3 (17.8) years; 55 460 encounters (61.9%) were with female patients and 34 196 (38.1%) were with male patients; and 3457 encounters (3.9%) were with Asian patients, 10 478 (11.7%) with Black patients, 72 894 (81.3%) with White patients, and 2287 (3.2%) with patients of other race or ethnicity (Latino and multiracial). The mean (SD) wRVUs per outpatient dermatology encounter was 1.44 (0.88) before the update and 1.80 (0.99) after (P < .001). After 2021, adjusted analyses demonstrated significantly fewer wRVUs per encounter for female (β, -0.11; 95% CI, -0.13 to -0.10) compared with male patients, and for younger (β, 0.04 [95% CI, 0.04 to 0.05] per 10-year increase in age) compared with older patients. After the update, compared with White patients, visits with Asian patients generated fewer wRVUs (β, -0.12; 95% CI, -0.17 to -0.08) as did visits with Black patients (β, -0.14; 95% CI, -0.17 to -0.11), both statistically significant reductions compared with prior comparisons (P < .001 for both). After 2021, mediation analysis identified that premalignant destructions and biopsies mediated many of the remaining differences in wRVU generation by patient age, race, and sex.

CONCLUSIONS AND RELEVANCE: This study found that after the 2021 Medicare fee schedule updates, there was a persistent, albeit reduced, gap between wRVU productivity in outpatient dermatology visits for Asian and Black compared with White patients. These persisting differences were attributable to skin biopsies and cryotherapy of premalignant lesions.

PMID:39714835 | DOI:10.1001/jamadermatol.2024.5286

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Firearm and Motor Vehicle Pediatric Deaths-Intersections of Age, Sex, Race, and Ethnicity

JAMA Pediatr. 2024 Dec 23. doi: 10.1001/jamapediatrics.2024.5089. Online ahead of print.

ABSTRACT

IMPORTANCE: Injuries from firearms and motor vehicle crashes (MVCs) are the leading causes of death among US children and youths aged 0 to 19 years. Examining the intersections of age group, sex, race, and ethnicity is essential to focus prevention efforts.

OBJECTIVE: To examine firearm and motor vehicle fatality rates by population subgroups and analyze changes over time.

DESIGN, SETTING, PARTICIPANTS: This cross-sectional study of firearm and MVC fatalities among US children and youths aged 0 to 19 years from the Centers for Disease Control and Prevention Web-Based Injury Statistics and Query Reporting System from 2011 to 2021. Participants included American Indian and Alaska Native; Asian, Hawaiian Native, and Pacific Islander; Black; Hispanic; and White youths. Data analysis was conducted from July 2023 to May 2024.

EXPOSURE: Firearm or MVC fatality.

MAIN OUTCOME MEASURES: Firearm and MVC fatality rates by year and over time, as measured by the Joinpoint regression annual percent change (APC).

RESULTS: From 2011 to 2021 there were 35 684 firearm and 40 735 MVC fatalities among US youths aged 0 to 19 years. For firearm fatalities, there were 21 332 homicides (59.8%), 12 113 suicides (33.9%), 1359 unintentional shootings (3.8%), 277 by legal enforcement (0.8%), and 603 from unknown intents (1.6%). When considering the intersections of age group, sex, race, and ethnicity, for firearm homicides among youths aged 15 to 19 years, the APCs were similar for Black (21.8%) and Hispanic (22.2%) males from 2018 to 2021, although with different peak rates (104.22 per 100 000 individuals and 17.80 per 100 000 individuals, respectively, in 2021). Black females aged 15 to 19 years demonstrated a dramatic APC increase of 40.7% from 2019 to 2021 (peak rate, 14.07 per 100 000 individuals). For firearm suicide in youths aged 10 to 19 years by sex, Black females had the greatest APC increase of 22.0% from 2016 to 2021. For MVC fatalities, the highest APC increase of 24.9% occurred among American Indian and Alaska Native females aged 15 to 19 years from 2018 to 2021. The highest MVC fatality rates occurred in 2021 among American Indian and Alaska Native males (38.16 per 100 000 individuals) and females (29.31 per 100 000 individuals) aged 15 to 19 years.

CONCLUSIONS AND RELEVANCE: In this cross-sectional study, US youths aged 0 to 19 years experienced important disparities in firearm and MVC fatality rates and increases over time when considering the intersectionality by age group, sex, race, and ethnicity. These findings suggest that a multipronged strategy focused on individual, community, and policy level approaches for specific high-risk groups for each injury mechanism is necessary to address these leading causes of death in US youths.

PMID:39714814 | DOI:10.1001/jamapediatrics.2024.5089

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Interpretation of research on patient volumes

Ned Tijdschr Geneeskd. 2024 Dec 26;168:D8275.

ABSTRACT

Healthcare research into patient volumes and volume-outcome relations can have far-reaching consequences. By means of a thought experiment, five core elements of valid research into patient volumes are identified: variation in numbers of patients, scalability of capacity, comparability regarding quality of care, comparability regarding groups of patients, and statistical precision. Practical challenges are described for each of these aspects as well as their possible impact on research quality. This is illustrated using the example of volume-outcome relations in the field of pediatric cardiac surgery.

PMID:39714806

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Less iron deficiency in whole-blood donors: the effect of ferritin-guided donation intervals

Ned Tijdschr Geneeskd. 2024 Dec 31;8:D8402.

ABSTRACT

OBJECTIVE: To evaluate the effect of ferritin-guided donation intervals on haemoglobin (Hb) and ferritin levels, iron deficiency and low Hb deferrals in whole-blood donors.

DESIGN: A cluster-randomized stepped-wedge trial.

METHODS: In 2017-2019, Sanquin gradually implemented ferritin-guided donation intervals. Ferritin levels are measured in new donors and at every fifth donation. Donors with ferritin levels ≤ 30 ng/mL are deferred for 6-12 months. Additionally, we assessed donor return within six months.

RESULTS: In the 36 months following the implementation of the policy, the percentage of donors with iron deficiency, low ferritin, and low Hb decreased. Additionally, Hb and ferritin levels increased significantly compared to the previous policy. In males, odds of return decreased significantly after implementation of the new policy.

CONCLUSION: Ferritin-guided donation intervals effectively improve donors’ iron status, but necessitate additional efforts in donor recruitment and retention.

PMID:39714800