OBJECTIVE: Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies (MINERVA), a European Medicines Agency-funded project (EUPAS39322), defined a set of metadata to describe real-world data sources (RWDSs) and piloted metadata collection in a prototype catalogue to assist investigators from data source discoverability through study conduct.
METHODS: A list of metadata was created from a review of existing metadata catalogues and recommendations, structured interviews, a stakeholder survey, and a technical workshop. The prototype was designed to comply with the FAIR principles (findable, accessible, interoperable, reusable), using MOLGENIS software. Metadata collection was piloted by 15 data access partners (DAPs) from across Europe.
RESULTS: A total of 442 metadata variables were defined in six domains: institutions (organizations connected to a data source); data banks (data collections sustained by an organization); data sources (collections of linkable data banks covering a common underlying population); studies; networks (of institutions); and common data models (CDMs). A total of 26 institutions were recorded in the prototype. Each DAP populated the metadata of one data source and its selected data banks. The number of data banks varied by data source; the most common data banks were hospital administrative records and pharmacy dispensation records (10 data sources each). Quantitative metadata were successfully extracted from three data sources conforming to different CDMs and entered into the prototype.
CONCLUSIONS: A metadata list was finalized, a prototype was successfully populated, and a good practice guide was developed. Setting up and maintaining a metadata catalogue on RWDSs will require substantial effort to support discoverability of data sources and reproducibility of studies in Europe.

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OBJECTIVE: Ultrasound (US) can detect subclinical joint-inflammation in patients with clinically suspect arthralgia (CSA), which is valuable as predictor for rheumatoid arthritis (RA) development. In most research protocols both hands and forefeet are scanned, but it is unclear if US of the forefeet has additional value for predicting RA, especially since synovial hypertrophy in MTP-joints of healthy individuals is also common. To explore the possibility to omit scanning of the forefeet we determined if US of the forefeet is of additional predictive value for RA-development in CSA patients.
METHODS: CSA patients of two independent cohorts underwent US of the hands and forefeet. We analyzed the association between RA-development and US-positivity for the full US-protocol, the full US-protocol with correction for Gray Scale(GS)-findings in the forefeet of healthy and the protocol without-forefeet.
RESULTS: In total, 298 CSA patients were studied. In patients with a positive US, subclinical joint-inflammation was mostly present in the hands (90-86%). Only 10-14% of patients had subclinical joint-inflammation solely in the forefeet. US-positivity was associated with inflammatory arthritis development in both cohorts, with HRs 2.6(95%CI 0.9-7.5) and 3.1(95%CI 1.5-6.4) for the full protocol, 3.1(95%CI 1.3-7.7) and 2.7(95%CI 1.3-5.4) for the full US-protocol with correction, and 3.1(95%CI 1.4-6.9) and 2.8(95%CI 1.4-5.6) without the forefeet. AUROCs were equal across both cohorts.
CONCLUSIONS: The forefeet can be omitted when US is used for the prediction of RA-development in CSA patients. This is due to the finding that subclinical joint-inflammation in the forefeet without concomitant inflammation in the hands is infrequent.

OBJECTIVE: Iodine, combined with antithyroid drugs, is recommended as an initial pharmacologic treatment for thyroid storm according to some clinical guidelines. However, the clinical efficacy of iodine in managing thyroid storm remains unexplored. This study aimed to determine whether early potassium iodide (KI) use is associated with mortality in patients hospitalized for thyroid storm.
METHODS: Using the Japanese Diagnosis Procedure Combination database, we identified patients hospitalized with thyroid storm between July 2010 and March 2022. We compared in-hospital mortality, length of stay, and total hospitalization costs between patients who received KI within two days of admission (KI group) versus those who did not (non-KI group). Prespecified subgroup analyses were performed based on the presence of the diagnosis of Graves\' disease.
RESULTS: Among 3,188 eligible patients, 2,350 received KI within two days of admission. The crude in-hospital mortality was 6.1% (143/2,350) in the KI group and 7.8% (65/838) in the non-KI group. After adjusting for potential confounders, KI use was not significantly associated with in-hospital mortality (odds ratio [OR] for KI use, 0.91; 95% confidence interval [CI], 0.62-1.34). In patients with the diagnosis of Graves\' disease, in-hospital mortality was lower in the KI group than in the non-KI group (OR, 0.46; 95% CI, 0.25-0.88). No significant difference in in-hospital mortality was observed in patients without the diagnosis of Graves\' disease (OR, 1.11; 95% CI, 0.67-1.85). Length of stay was shorter (subdistribution hazard ratio, 1.15; 95% CI, 1.05-1.27), and total hospitalization costs were lower (OR, 0.92; 95% CI, 0.85-1.00) in the KI group compared with the non-KI group.
CONCLUSIONS: Our findings suggest that KI may reduce in-hospital mortality among patients hospitalized for thyroid storm with Graves\' disease.

Background: The ability to predict a long duration of mechanical ventilation (MV) by clinicians is very limited. We assessed the value of machine learning (ML) for early prediction of the duration of MV > 14 days in patients with moderate-to-severe acute respiratory distress syndrome (ARDS). Methods: This is a development, testing, and external validation study using data from 1173 patients on MV ≥ 3 days with moderate-to-severe ARDS. We first developed and tested prediction models in 920 ARDS patients using relevant features captured at the time of moderate/severe ARDS diagnosis, at 24 h and 72 h after diagnosis with logistic regression, and Multilayer Perceptron, Support Vector Machine, and Random Forest ML techniques. For external validation, we used an independent cohort of 253 patients on MV ≥ 3 days with moderate/severe ARDS. Results: A total of 441 patients (48%) from the derivation cohort (n = 920) and 100 patients (40%) from the validation cohort (n = 253) were mechanically ventilated for >14 days [median 14 days (IQR 8-25) vs. 13 days (IQR 7-21), respectively]. The best early prediction model was obtained with data collected at 72 h after moderate/severe ARDS diagnosis. Multilayer Perceptron risk modeling identified major prognostic factors for the duration of MV > 14 days, including PaO2/FiO2, PaCO2, pH, and positive end-expiratory pressure. Predictions of the duration of MV > 14 days showed modest discrimination [AUC 0.71 (95%CI 0.65-0.76)]. Conclusions: Prolonged MV duration in moderate/severe ARDS patients remains difficult to predict early even with ML techniques such as Multilayer Perceptron and using data at 72 h of diagnosis. More research is needed to identify markers for predicting the length of MV. This study was registered on 14 August 2023 at ClinicalTrials.gov (NCT NCT05993377).

To identify and summarize the presence and characteristics of dental patient-reported outcomes (dPROs) and dental patient-reported outcome measures (dPROMs) within comparative observational studies published in 5 leading orthodontic journals.
Electronic searching was performed to identify intervention (therapeutic or preventive) related comparative observational studies published in selected journals between 2015 and 2021. Two authors extracted the characteristics of each included study independently and in duplicate and summarized the dPROs and dPROMs used in these studies. All dPROs were classified into 2 general types (oral health-related quality of life [OHRQoL] and others), while dPROMs were divided into 3 categories (single-item questionnaires, generic multiple-item questionnaires, and specific multiple-item questionnaires). In addition, dPROMs were examined, if they evaluated the 4 dimensions of OHRQoL (oral function, orofacial pain, orofacial appearance, and psychosocial impact).
A total of 683 observational studies were eligible and included of which 117 (17.1%) used dPROs and dPROMs. Seven different dPROs (OHRQoL, patients\' satisfaction with treatment, preferences, concerns, compliance, duration, and unwanted events) and 33 different dPROMs (including 8 single-item questionnaires, 11 generic multiple-item questionnaires, and 14 specific multiple-item questionnaires) were identified in these studies. OHRQoL was the most commonly used dPRO (92/117, 78.6%), while Oral Health Impact Profile 14 (OHIP-14) was the most frequently used dPROM (20/92, 21.7%). In terms of study design, cross-sectional studies had the highest proportion of dPRO usage (62/148, 41.9%), followed by cohort studies (63/505, 12.5%) and case-control studies (1/30, 3.3%).
Only one-sixth of comparative observational studies published in leading orthodontic journals could reflect patients\' perspectives. Observational studies in orthodontics need to provide more patient-important information through the use of dPROs and dPROMs.

BACKGROUND: Estimates of prevalence of musculoskeletal pain in children and adolescents vary considerably and the impact of pain on children\'s life is often not considered.
OBJECTIVE: To determine the one-month prevalence of disabling musculoskeletal pain in children and adolescents. The secondary aims are to: 1) determine the body region with the highest prevalence; 2) understand the characteristics of the children with disabling musculoskeletal pain; and 3) describe the parents\' perception of the prevalence.
METHODS: This cross-sectional study was conducted in public and private schools in the states of São Paulo and Ceará, Brazil. Children self-reported presence and impact of pain, pain intensity, psychosomatic symptoms, and quality of life. Parents completed parent-proxy versions and perception of the child\'s sleep quality. Descriptive statistics were used to summarise the data.
RESULTS: A total of 2,688 children and adolescents were included in this study. The prevalence of disabling musculoskeletal pain in the previous month was 27.1%. The back was the region most often affected (51.8%). Children with disabling musculoskeletal pain were older, heavier, had worse relationships with their family, perceived their backpacks as heavy, carried their backpacks more with one shoulder, had more negative psychosomatic symptoms, had poorer quality of life, and had higher pain intensity. Parents tended to underestimate the presence of pain in their children.
CONCLUSIONS: The one-month prevalence of activity limiting musculoskeletal pain in children and adolescents was 27.1% with the back being the most often affected body region. Parents tended to underestimate the presence of pain in their children.

BACKGROUND: The association between antihypertensive medication and schizophrenia has received increasing attention; however, evidence of the impact of antihypertensive medication on subsequent schizophrenia based on large-scale observational studies is limited. We aimed to compare the schizophrenia risk in large claims-based US and Korea cohort of patients with hypertension using angiotensin-converting enzyme (ACE) inhibitors versus those using angiotensin receptor blockers (ARBs) or thiazide diuretics.
METHODS: Adults aged 18 years who were newly diagnosed with hypertension and received ACE inhibitors, ARBs, or thiazide diuretics as first-line antihypertensive medications were included. The study population was sub-grouped based on age (> 45 years). The comparison groups were matched using a large-scale propensity score (PS)-matching algorithm. The primary endpoint was incidence of schizophrenia.
RESULTS: 5,907,522; 2,923,423; and 1,971,549 patients used ACE inhibitors, ARBs, and thiazide diuretics, respectively. After PS matching, the risk of schizophrenia was not significantly different among the groups (ACE inhibitor vs. ARB: summary hazard ratio [HR] 1.15 [95% confidence interval, CI, 0.99-1.33]; ACE inhibitor vs. thiazide diuretics: summary HR 0.91 [95% CI, 0.78-1.07]). In the older subgroup, there was no significant difference between ACE inhibitors and thiazide diuretics (summary HR, 0.91 [95% CI, 0.71-1.16]). The risk for schizophrenia was significantly higher in the ACE inhibitor group than in the ARB group (summary HR, 1.23 [95% CI, 1.05-1.43]).
CONCLUSIONS: The risk of schizophrenia was not significantly different between the ACE inhibitor vs. ARB and ACE inhibitor vs. thiazide diuretic groups. Further investigations are needed to determine the risk of schizophrenia associated with antihypertensive drugs, especially in people aged > 45 years.

Weighting is a general and often-used method for statistical adjustment. Weighting has two objectives: first, to balance covariate distributions, and second, to ensure that the weights have minimal dispersion and thus produce a more stable estimator. A recent, increasingly common approach directly optimizes the weights toward these two objectives. However, this approach has not yet been feasible in large-scale datasets when investigators wish to flexibly balance general basis functions in an extended feature space. To address this practical problem, we describe a scalable and flexible approach to weighting that integrates a basis expansion in a reproducing kernel Hilbert space with state-of-the-art convex optimization techniques. Specifically, we use the rank-restricted Nyström method to efficiently compute a kernel basis for balancing in nearly linear time and space, and then use the specialized first-order alternating direction method of multipliers to rapidly find the optimal weights. In an extensive simulation study, we provide new insights into the performance of weighting estimators in large datasets, showing that the proposed approach substantially outperforms others in terms of accuracy and speed. Finally, we use this weighting approach to conduct a national study of the relationship between hospital profit status and heart attack outcomes in a comprehensive dataset of 1.27 million patients. We find that for-profit hospitals use interventional cardiology to treat heart attacks at similar rates as other hospitals but have higher mortality and readmission rates.

BACKGROUND: Crossfit is a sport that combines cardio-respiratory and muscle endurance, strength, flexibility, muscle power, speed, coordination, agility and balance. However, there is no information in the literature regarding functional performance of the lower limbs and the endurance of core muscles in this population. The objective of this study was to evaluate the correlation between trunk strength/endurance and lower limb function through lower limb symmetry and balance tests.
METHODS: Forty-one young adults aged 19-41 years (26.3 ± 5.4) participated, 15 sedentary and 26 cross fit practitioners for at least one year. The tests were as follows: Biering-Sørensen Test of trunk extensor endurance, Trunk Flexors Endurance Test at 60°, Side Plank Endurance Test, Lumbar Dynamometry, Single-Leg Hop Test and Star Excursion Balance Test.
CONCLUSIONS: Although there were higher values, there was no significant difference (p > 0.05) between the groups for lower limb symmetry and strength of trunk flexor muscles. For balance, strength and resistance variables of trunk extensor muscles, the values found were higher in crossfit practitioners than in sedentary subjects.
CONCLUSIONS: There is a relationship between trunk muscle strength and endurance and lower limb balance. Moreover, cross fit athletes showed higher values of trunk muscle strength/endurance and lower limb balance compared to sedentary adults.