Category: Statistics

JAMA Pediatr. 2024 Oct 28. doi: 10.1001/jamapediatrics.2024.4376. Online ahead of print.

ABSTRACT

IMPORTANCE: Parenting is associated with brain development and long-term health outcomes, although whether these associations depend on the developmental timing of exposure remains understudied. Identifying these sensitive periods can inform when and how parenting is associated with neurodevelopment and risk for mental illness.

OBJECTIVE: To characterize how harsh and warm parenting during early, middle, and late childhood are associated with brain architecture during adolescence and, in turn, psychiatric symptoms in early adulthood during the COVID-19 pandemic.

DESIGN, SETTING, AND PARTICIPANTS: This population-based, 21-year observational, longitudinal birth cohort study of low-income youths and families from Detroit, Michigan; Toledo, Ohio; and Chicago, Illinois, used data from the Future of Families and Child Well-being Study. Data were collected from February 1998 to June 2021. Analyses were conducted from May to October 2023.

EXPOSURES: Parent-reported harsh parenting (psychological aggression or physical aggression) and observer-rated warm parenting (responsiveness) at ages 3, 5, and 9 years.

MAIN OUTCOMES AND MEASURES: The primary outcomes were brainwide (segregation, integration, and small-worldness), circuit (prefrontal cortex [PFC]-amygdala connectivity), and regional (betweenness centrality of amygdala and PFC) architecture at age 15 years, determined using functional magnetic resonance imaging, and youth-reported anxiety and depression symptoms at age 21 years. The structured life-course modeling approach was used to disentangle timing-dependent from cumulative associations between parenting and brain architecture.

RESULTS: A total of 173 youths (mean [SD] age, 15.88 [0.53] years; 95 female [55%]) were included. Parental psychological aggression during early childhood was positively associated with brainwide segregation (β = 0.30; 95% CI, 0.14 to 0.45) and small-worldness (β = 0.17; 95% CI, 0.03 to 0.28), whereas parental psychological aggression during late childhood was negatively associated with PFC-amygdala connectivity (β = -0.37; 95% CI, -0.55 to -0.12). Warm parenting during middle childhood was positively associated with amygdala centrality (β = 0.23; 95% CI, 0.06 to 0.38) and negatively associated with PFC centrality (β = -0.18; 95% CI, -0.31 to -0.03). Warmer parenting during middle childhood was associated with reduced anxiety (β = -0.05; 95% CI -0.10 to -0.01) and depression (β = -0.05; 95% CI -0.10 to -0.003) during early adulthood via greater adolescent amygdala centrality.

CONCLUSIONS AND RELEVANCE: Neural associations with harsh parenting were widespread across the brain in early childhood but localized in late childhood. Neural associations with warm parenting were localized in middle childhood and, in turn, were associated with mental health during future stress. These developmentally contingent associations can inform the type and timing of interventions.

PMID:39466276 | DOI:10.1001/jamapediatrics.2024.4376

Am J Gastroenterol. 2024 Oct 11. doi: 10.14309/ajg.0000000000003131. Online ahead of print.

ABSTRACT

INTRODUCTION: Rising healthcare costs have led to decreasing reimbursements for various procedures and providers. We chose to analyze Medicare reimbursement trends for 26 esophagogastroduodenoscopy (EGD) and 31 colonoscopy current procedural terminology (CPT) codes from 2018 to 2023 for hospital outpatient centers, ambulatory surgical centers and gastroenterologists. We also wanted to look at the effects of inflation on these Medicare reimbursements.

METHODS: We calculated the nominal percentage change from 2018 to 2023 for each CPT code. We then took inflation data provided by the U.S. Bureau of Labor Statistics and calculated the real change in reimbursements from 2018 to 2023 for each of the 31 colonoscopy and 26 EGD CPT codes.

RESULTS: Our results show that while nominal reimbursements to physicians have been steadily declining for performing gastrointestinal procedures, nominal reimbursements to hospital outpatient and ambulatory surgical centers have been increasing from 2018 to 2023. After taking into account inflation, physicians saw significant decreases in real purchasing power for performing EGD and colonoscopies. Ambulatory surgical centers and hospital outpatient centers saw reimbursements keep up with inflation.

DISCUSSION: Physician reimbursements by Medicare for gastroenterology procedures make up a small portion of the reimbursements by Medicare to facilities like ambulatory surgical centers and hospital outpatient centers. However physicians have seen significant reimbursement cuts while facilities have not. Moreover, higher inflation leads to increased expenses for gastroenterology practices. It remains to be seen how these reimbursement changes will affect patients access to care as well as physicians practice sustainability.

PMID:39466273 | DOI:10.14309/ajg.0000000000003131

JAMA Pediatr. 2024 Oct 28. doi: 10.1001/jamapediatrics.2024.4699. Online ahead of print.

ABSTRACT

IMPORTANCE: In 2017, New York, New York, launched the United States’ first right-to-counsel program, guaranteeing lawyers to low-income tenants in select zip codes, which was associated with reducing eviction risk by half. Given documented associations between evictions during pregnancy and adverse birth outcomes, the right-to-counsel program may be associated with improved birth outcomes.

OBJECTIVE: To measure associations between zip code-level right-to-counsel access and risk of adverse birth outcomes, including preterm birth and low birth weight, among infants born to Medicaid-insured birthing parents.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study leveraged the staggered rollout of New York’s right-to-counsel program from January 2016 to February 2020 as a natural experiment using a population-based sample of live births to Medicaid-insured birthing parents residing in New York, New York. Data were analyzed from February 2022 to September 2024.

EXPOSURE: Zip code right-to-counsel status 9 months prior to birth.

MAIN OUTCOMES AND MEASURES: Adverse birth outcomes were measured using individual birth records from the New York Bureau of Vital Statistics. Outcomes included dichotomous indicators of low birth weight (<2500 g), preterm birth (<37 weeks’ gestation), and a composite of both. Difference-in-differences linear probability models controlled for year, month, and zip code and included clustered standard errors.

RESULTS: Among 260 493 live births (mean [SD] birthing parent age, 29 [6] years) from January 2016 to February 2020, 43 081 births (17%) were to birthing parents residing in zip codes where right-to-counsel was available during pregnancy. Exposure to right-to-counsel during pregnancy was associated with statistically significant reductions in infants’ probability of adverse birth outcomes, with reductions of 0.73 (95% CI, 0.06-1.41) percentage points in low birth weight, 0.91 (95% CI, 0.10-1.71) percentage points in preterm birth, and 0.96 (95% CI, 0.09-1.84) percentage points in the composite outcome in treated vs untreated zip codes.

CONCLUSIONS AND RELEVANCE: This cohort study found that right-to-counsel was associated with reduced risk of adverse birth outcomes among Medicaid-insured birthing parents. These findings suggest that eviction prevention via right-to-counsel may have benefits that extend beyond the courtroom and across the life-course.

PMID:39466257 | DOI:10.1001/jamapediatrics.2024.4699

JAMA Netw Open. 2024 Oct 1;7(10):e2440969. doi: 10.1001/jamanetworkopen.2024.40969.

ABSTRACT

IMPORTANCE: Large language models (LLMs) have shown promise in their performance on both multiple-choice and open-ended medical reasoning examinations, but it remains unknown whether the use of such tools improves physician diagnostic reasoning.

OBJECTIVE: To assess the effect of an LLM on physicians’ diagnostic reasoning compared with conventional resources.

DESIGN, SETTING, AND PARTICIPANTS: A single-blind randomized clinical trial was conducted from November 29 to December 29, 2023. Using remote video conferencing and in-person participation across multiple academic medical institutions, physicians with training in family medicine, internal medicine, or emergency medicine were recruited.

INTERVENTION: Participants were randomized to either access the LLM in addition to conventional diagnostic resources or conventional resources only, stratified by career stage. Participants were allocated 60 minutes to review up to 6 clinical vignettes.

MAIN OUTCOMES AND MEASURES: The primary outcome was performance on a standardized rubric of diagnostic performance based on differential diagnosis accuracy, appropriateness of supporting and opposing factors, and next diagnostic evaluation steps, validated and graded via blinded expert consensus. Secondary outcomes included time spent per case (in seconds) and final diagnosis accuracy. All analyses followed the intention-to-treat principle. A secondary exploratory analysis evaluated the standalone performance of the LLM by comparing the primary outcomes between the LLM alone group and the conventional resource group.

RESULTS: Fifty physicians (26 attendings, 24 residents; median years in practice, 3 [IQR, 2-8]) participated virtually as well as at 1 in-person site. The median diagnostic reasoning score per case was 76% (IQR, 66%-87%) for the LLM group and 74% (IQR, 63%-84%) for the conventional resources-only group, with an adjusted difference of 2 percentage points (95% CI, -4 to 8 percentage points; P = .60). The median time spent per case for the LLM group was 519 (IQR, 371-668) seconds, compared with 565 (IQR, 456-788) seconds for the conventional resources group, with a time difference of -82 (95% CI, -195 to 31; P = .20) seconds. The LLM alone scored 16 percentage points (95% CI, 2-30 percentage points; P = .03) higher than the conventional resources group.

CONCLUSIONS AND RELEVANCE: In this trial, the availability of an LLM to physicians as a diagnostic aid did not significantly improve clinical reasoning compared with conventional resources. The LLM alone demonstrated higher performance than both physician groups, indicating the need for technology and workforce development to realize the potential of physician-artificial intelligence collaboration in clinical practice.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT06157944.

PMID:39466245 | DOI:10.1001/jamanetworkopen.2024.40969

JAMA Netw Open. 2024 Oct 1;7(10):e2440977. doi: 10.1001/jamanetworkopen.2024.40977.

ABSTRACT

IMPORTANCE: Despite research supporting the benefits of early palliative care, timely initiation by gynecologic oncology patients is reportedly low, which may limit the effectiveness of palliative care.

OBJECTIVE: To investigate the association of the timing of palliative care initiation with the aggressiveness of end-of-life care using established quality indicators among patients with ovarian cancer.

DESIGN, SETTING, AND PARTICIPANTS: This population-based retrospective cohort study of ovarian cancer decedents used linked administrative health care data to identify palliative care provision across all health care sectors and health care professionals (specialist and nonspecialist) and end-of-life quality indicators in Ontario, Canada, from 2006 to 2018. Data analyses were performed July 12, 2024.

MAIN OUTCOMES AND MEASURES: The primary outcome was the associations between the timing of palliative care and end-of-life quality indicators, including emergency department use, hospital or intensive care unit admission in the last 30 days of life, chemotherapy in last 14 days of life, death in the hospital, and a composite measure of aggressive care. Late palliative care was defined as 3 months or less prior to death.

RESULTS: There were 8297 ovarian cancer decedents. Their mean (SD) age at death was 69.6 (13.1) years, and their mean (SD) oncologic survival was 2.8 (3.9) years. Among 3958 patients with known cancer stage, 3495 (88.3%) presented with stage III or IV disease. One-third of patients (2667 [32.1%]) received late palliative care in the final 3 months of life. Results of multivariable regression analysis indicated that any palliative care initiated earlier than 3 months before death was associated with lower rates of aggressive end-of-life care (odds ratio [OR], 0.47 [95% CI, 0.37-0.60]), death in hospital (OR, 0.54 [95% CI, 0.45-0.65]), and intensive care unit admission (OR, 0.46 [95% CI, 0.27-0.76]). Specialist palliative consultation from 3 months up to 6 monts before death was associated with decreased likelihood of late chemotherapy (OR, 0.46 [95% CI, 0.24-0.88]).

CONCLUSIONS: Findings from this cohort study suggested that early palliative care may be associated with less-aggressive end-of-life care than late palliative care. Implementation strategies for early palliative care initiation are needed to optimize care quality and health resource utilization at the end of life.

PMID:39466244 | DOI:10.1001/jamanetworkopen.2024.40977

JAMA Netw Open. 2024 Oct 1;7(10):e2441288. doi: 10.1001/jamanetworkopen.2024.41288.

ABSTRACT

IMPORTANCE: Community Paramedicine at Clinic (CP@clinic) is a chronic disease prevention program that decreases 911 calls for emergency medical services, but its wider system effects are unknown.

OBJECTIVE: To evaluate the effects of CP@clinic vs usual care on individual-level health service utilization outcomes.

DESIGN, SETTING, AND PARTICIPANTS: This open-label, pragmatic cluster randomized clinical trial evaluated all residents 55 years or older in 30 social housing buildings in Ontario, Canada, that had (1) a unique postal code, (2) at least 50 apartments, (3) 60% or more residents 55 years or older, and (4) a similar building for pairing (15 intervention and 15 control buildings, pair-matched randomization). The 12-month intervention had a staggered start date from January 1, 2015, to December 1, 2015, and ended between December 31, 2015, and November 30, 2016. Administrative health data analysis was conducted in May 2022.

INTERVENTION: CP@clinic was a health promotion and disease prevention program led by specially trained community paramedics who held weekly drop-in sessions in social housing buildings. These paramedics conducted 1-on-1 risk assessments, provided health education and referrals to relevant community resources, and, with consent, sent assessments to family physicians. Control buildings received usual care (universal health care, including free primary and specialty medical care).

MAIN OUTCOME AND MEASURES: Individual-level health service utilization was measured from administrative health data, with ED visits via ambulance as the primary outcome; secondary outcomes included ED visits for any reason, primary care visits, hospitalizations, length of hospital stay, laboratory tests, receipt of home care, transfer to long-term care, and medication initiation. Generalized estimating equations were used to estimate intervention effects on individual-level health service utilization, accounting for trial design and individual-level baselines.

RESULTS: The 30 social housing buildings had 3695 residents (1846 control and 1849 intervention participants; mean [SD] age, 72.8 [9.1] years; 2400 [65.0%] female). Intention-to-treat analysis found no significant difference in ED visits by ambulance (445 of 1849 [24.1%] vs 463 of 1846 [25.1%]; adjusted odds ratio [AOR], 0.97; 95% CI, 0.89-1.05) but found higher antihypertensive medication initiation (74 of 500 [14.8%] vs 47 of 552 [8.5%]; AOR, 1.74; 95% CI, 1.19-2.53) and lower anticoagulant initiation (48 of 1481 [3.2%] vs 69 of 1442 [4.8%]; AOR, 0.68; 95% CI, 0.53-0.86) in the intervention arm vs the control arm. CP@clinic attendance was associated with higher incidence of primary care visits (adjusted incidence rate ratio, 1.10; 95% CI, 1.03-1.17), higher odds of receiving home care (AOR, 1.07; 95% CI, 1.01-1.13), and lower odds of long-term care transfers (AOR, 0.32; 95% CI, 0.13-0.81).

CONCLUSIONS AND RELEVANCE: In this cluster randomized clinical trial of CP@clinic, the intervention did not affect the rate of ED visits by ambulance; however, there were increased primary care visits and connections to home care services, which may have increased antihypertensive medication initiation and reduced long-term care transfers from social housing. Health policymakers should consider CP@clinic’s impact as an upstream approach to improve care for older adults with low income.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02152891.

PMID:39466243 | DOI:10.1001/jamanetworkopen.2024.41288

JAMA Netw Open. 2024 Oct 1;7(10):e2441531. doi: 10.1001/jamanetworkopen.2024.41531.

ABSTRACT

IMPORTANCE: The underrepresentation of Black men in the health care workforce, particularly among physician assistants and associates (PAs), represents a missed opportunity to alleviate shortages of health care professionals and enhance workforce diversity. Increasing the number of Black men in the training pipeline could significantly benefit education, patient care, and overall health outcomes.

OBJECTIVE: To analyze patterns from 2013 to 2021 among Black men applying to and matriculating into PA programs and compare these figures with the age-specific US population of Black men.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study assessed deidentified application and matriculation data from the Central Application Service for Physician Assistants (CASPA) for PA training programs in the US, alongside US Census data. CASPA applicants reporting race and gender identities as Black male were included. Data were obtained March 10, 2023, from the 2012-2013 to the 2020-2021 application cycles; data were analyzed from June 2023 to May 2024.

EXPOSURES: Black male applicants and matriculation.

MAIN OUTCOMES AND MEASURES: Patterns and proportion of Black male applicants and matriculants to PA programs relative to total rates and expected numbers.

RESULTS: From 2013 to 2021, PA programs grew 64.3%, with an increase in applicants from 19 761 to 30 196 and matriculants from 6192 to 11 115. Despite this growth, the representation of Black men among applicants (from 435 to 732) and matriculants (from 73 to 156) remained stagnant, averaging 2.2% and 1.2%, respectively, significantly lower than their 8.7% (3 920 231 individuals aged 20-29 years) representation in the US Census. In 2021, the matriculation rate for Black men (156 of 732 [21.3%]) was notably lower than the matriculation rate for all applicants (11 115 of 30 196 [36.8%]). Based on the expected proportion of Black men in the PA applicant age range, there should have been 2641 applicants (actual: 732) and 972 matriculants (actual: 156) across 308 PA programs in 2021; these numbers indicate that, per program, approximately 9 applicants would have to have been evaluated and 3 matriculated to achieve parity, in contrast to the mean of 2 applicants and 1 matriculant per 2 programs.

CONCLUSIONS AND RELEVANCE: In this cohort study of PA applicants and matriculants, Black men remained substantially underrepresented despite overall growth of PA training programs. The low representation among matriculants was due in part to the low numbers of applicants but also to substantially lower matriculation success. This persistent underrepresentation highlights systemic barriers and underscores the need for targeted interventions to achieve a more representative health care workforce. To achieve equitable admissions, each PA program should aim to evaluate 9 Black male applicants and matriculate 3 Black men annually.

PMID:39466242 | DOI:10.1001/jamanetworkopen.2024.41531

JAMA Netw Open. 2024 Oct 1;7(10):e2441970. doi: 10.1001/jamanetworkopen.2024.41970.

ABSTRACT

IMPORTANCE: Obesity is associated with increased severity of COVID-19. Whether obesity is associated with an increased risk of post-acute sequelae of SARS-CoV-2 infection (PASC) among pediatric populations, independent of its association with acute infection severity, is unclear.

OBJECTIVE: To quantify the association of body mass index (BMI) status before SARS-CoV-2 infection with pediatric PASC risk, controlling for acute infection severity.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study occurred at 26 US children’s hospitals from March 2020 to May 2023 with a minimum follow-up of 179 days. Eligible participants included children and young adults aged 5 to 20 years with SARS-CoV-2 infection. Data analysis was conducted from October 2023 to January 2024.

EXPOSURES: BMI status assessed within 18 months before infection; the measure closest to the index date was selected. The BMI categories included healthy weight (≥5th to <85th percentile for those aged 5-19 years or ≥18.5 to <25 for those aged >19 years), overweight (≥85th to <95th percentile for those aged 5-19 years or ≥25 to <30 for for those aged >19 years), obesity (≥95th percentile to <120% of the 95th percentile for for those aged 5-19 years or ≥30 to <40 for those aged >19 years), and severe obesity (≥120% of the 95th percentile for those aged 5-19 years or ≥40 for those aged >19 years).

MAIN OUTCOMES AND MEASURES: To identify PASC, a diagnostic code specific for post-COVID-19 conditions was used and a second approach used clusters of symptoms and conditions that constitute the PASC phenotype. Relative risk (RR) for the association of BMI with PASC was quantified by Poisson regression models, adjusting for sociodemographic, acute COVID severity, and other clinical factors.

RESULTS: A total of 172 136 participants (mean [SD] age at BMI assessment 12.6 [4.4] years; mean [SD] age at cohort entry, 13.1 [4.4] years; 90 187 female [52.4%]) were included. Compared with participants with healthy weight, those with obesity had a 25.4% increased risk of PASC (RR, 1.25; 95% CI, 1.06-1.48) and those with severe obesity had a 42.1% increased risk of PASC (RR, 1.42; 95% CI, 1.25-1.61) when identified using the diagnostic code. Compared with those with healthy weight, there was an increased risk for any occurrences of PASC symptoms and conditions among those with obesity (RR, 1.11; 95% CI, 1.06-1.15) and severe obesity (RR, 1.17; 95% CI, 1.14-1.21), and the association held when assessing total incident occurrences among those with overweight (RR, 1.05; 95% CI, 1.00-1.11), obesity (RR, 1.13; 95% CI, 1.09-1.19), and severe obesity (RR, 1.18; 95% CI, 1.14-1.22).

CONCLUSIONS AND RELEVANCE: In this cohort study, elevated BMI was associated with a significantly increased PASC risk in a dose-dependent manner, highlighting the need for targeted care to prevent chronic conditions in at-risk children and young adults.

PMID:39466241 | DOI:10.1001/jamanetworkopen.2024.41970

JAMA Netw Open. 2024 Oct 1;7(10):e2444187. doi: 10.1001/jamanetworkopen.2024.44187.

ABSTRACT

IMPORTANCE: Sexuality- and gender-diverse (SGD) young people experience substantial health disparities relative to cisgender heterosexual peers. Little is known about SGD adolescents younger than 15 years.

OBJECTIVE: To describe SGD prevalence and associated factors in a population-representative cohort of younger adolescents in Australia.

DESIGN, SETTING, AND PARTICIPANTS: This prospective cohort study was part of the Future Proofing Study, with enrollment of year 8 students at 134 Australian secondary schools from 2019 to 2021 and annual follow-ups for 5 years. Data were analyzed from June 20, 2023, to June 6, 2024.

MAIN OUTCOME AND MEASURES: Outcomes of interest were baseline self-reported gender and sexuality identities, individual characteristics, and mental health and disability diagnoses, as well as school characteristics.

RESULTS: Among 6388 participants, median (IQR) age was 13.9 (13.6-15.8), with a range of 10.7 to 17.5 years. Most participants attended school in a major city (76.0%), were born in Australia (91.4%), and spoke English at home (93.7%). Approximately half (3122 participants; 48.9% [95% CI, 45.2%-59.0%]) identified as female or girls, and 46.5% (2973 participants; 95% CI, 39.8%-53.4%) identified as male or boys. The overall proportion of transgender identity was 3.3% (95% CI, 2.7%-3.9%), with 23 participants (0.4%) identifying as transgender boys, 10 participants (0.2%) identifying as transgender girls, 117 participants (1.8%) identifying as transgender nonbinary, and 59 participants (0.9%) identifying as another transgender identity. The overall proportion of sexuality diversity was 12.0% (95% CI, 10.4%-13.8%). The proportion of cisgender participants who were sexuality-diverse (13.0% [95% CI, 11.4%-14.8%] of girls and 4.7% [95% CI, 3.7%-5.9%] of boys) was lower than the proportion among gender-diverse participants, which ranged from 30.0% (95% CI, 9.3%-64.1%) of transgender girls to 91.5% (95% CI, 81.3%-96.4%) of those with another diverse gender identity. Gender diversity and sexuality diversity were strongly associated (odds ratio [OR], 66.24; 95% CI, 38.23-114.80), and both were negatively associated with age (gender diversity: OR per 1-year older, 0.61; 95% CI, 0.49-0.76; sexuality diversity: OR per 1-year older, 0.78; 95% CI, 0.65-0.93) and positively with mental health diagnosis (gender diversity: OR, 2.41; 95% CI, 1.79-3.24; sexuality diversity: OR, 2.50; 95% CI, 2.10-2.98), and disability diagnosis (gender diversity: OR, 2.39; 95% CI, 1.68-3.40; sexuality diversity: OR, 1.96; 95% CI, 1.64-2.36). While there were significant associations between individual and school characteristics and responses to gender and sexuality identity items, patterns of association differed, with no consistent association with economic disadvantage.

CONCLUSIONS AND RELEVANCE: This cohort study of young adolescents found higher rates of SGD than among samples of older adolescents. The significant associations with younger age, poorer mental health, and disability underscored the urgent need for inclusive programs to promote a safe and welcoming environment in schools, health care settings, and communities.

PMID:39466240 | DOI:10.1001/jamanetworkopen.2024.44187

JAMA Intern Med. 2024 Oct 28. doi: 10.1001/jamainternmed.2024.5726. Online ahead of print.

ABSTRACT

IMPORTANCE: Currently, there are no treatments for nocturnal leg cramps (NLCs) that have been proven to be both safe and effective. Seeking safe and effective approaches for managing NLCs is of crucial importance.

OBJECTIVE: To determine whether vitamin K2 is better than placebo in managing NLCs.

DESIGN, SETTING, AND PARTICIPANTS: This multicenter, double-blind, placebo-controlled randomized clinical trial was conducted in China between September 2022 and December 2023. This study used a volunteer sample comprising community-dwelling individuals 65 years and older with 2 or more documented episodes of NLCs during 2 weeks of screening. Researchers performed a history and physical screening of candidates recruited from the community through advertisements, and eligible participants were randomized in a 1:1 ratio to receive vitamin K2 or a placebo for 8 weeks.

INTERVENTIONS: Patients orally took capsules containing either vitamin K2 (menaquinone 7), 180 μg, or a similar-looking placebo every day for 8 weeks. The study products were custom manufactured to have identical packaging and for the capsules to have matching appearance and identical excipients that shared similar taste and weight.

MAIN OUTCOMES AND MEASURES: The primary outcome was the mean number of NLCs per week between the vitamin K2 and the placebo group. Secondary outcomes included the duration of muscle cramps measured in minutes and the severity of muscle cramps assessed using an analog scale ranging from 1 to 10.

RESULTS: Among the 310 participants, 111 participants were excluded. Of the 199 enrolled individuals, 108 (54.3%) were female, and the mean (SD) age was 72.3 (5.5) years. A total of 103 patients (51.8%) were randomly assigned to receive vitamin K2 and 96 (48.2%) were assigned to placebo. The mean (SD) baseline weekly frequency of cramps was comparable in both the vitamin K2 group (2.60 [0.81]) and the placebo group (2.71 [0.80]). During the 8-week intervention, the vitamin K2 group experienced a reduction in the mean (SD) weekly frequency of cramps to 0.96 (1.41). Meanwhile, the placebo group maintained mean (SD) weekly frequency of cramps at 3.63 (2.20). The between-group difference was statistically significant (difference, -2.67; 95% CI, -2.86 to -2.49; P < .001). The vitamin K2 group had a more significant mean (SD) reduction in NLC severity (-2.55 [2.12] points) compared with the placebo group (-1.24 [1.16] points). The vitamin K2 group exhibited a more pronounced mean (SD) decrease in the duration of NLCs (-0.90 [0.88] minutes) than the placebo group (-0.32 [0.78] minutes). No adverse events related to vitamin K2 use were identified.

CONCLUSIONS AND RELEVANCE: This randomized clinical trial showed that vitamin K2 supplementation significantly reduced the frequency, intensity, and duration of NLCs in an older population with good safety.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05547750.

PMID:39466236 | DOI:10.1001/jamainternmed.2024.5726