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Background:In systemic sclerosis interstitial lung disease (ILD) is the leading cause of mortality [1]. An important unmet clinical need is the to identify patients at risk to develop ILD early, in order to implement personalized monitoring strategies. Although no predictive algorithm is yet available in clinical care, nailfold capillaroscopy is emerging as a promising candidate biomarker to predict the onset of ILD [2].Objectives:The objective of this study was to evaluate the association between transitions in nailfold capillaroscopy patterns and incident ILD.Methods:Patient data from the EUSTAR database were collected of those patients who had least one ILD-free visit with a documented scleroderma pattern at nailfold capillaroscopy, spanning up to 5 years. The baseline for analysis was established as the first recorded ILD-free visit with a documented scleroderma pattern. Only data of patients fulfilling the following key criteria were included in the analysis: age ≥ 18 years, fulfilling ACR-EULAR classification criteria, disease duration from first non-Raynaud phenomenon ≤ 5 years, HRCT confirmed absence of ILD at baseline, at least one follow-up nailfold capillaroscopy, and a minimal follow-up duration of1 year.Mixed logistic regression models were constructed to assess the association between annual risk of ILD and nailfold capillaroscopy pattern. The model was corrected for a priori defined confounders, namely gender, diffuse cutaneous subtype, Caucasian ethnicity, presence of anti-topoisomerase-I antibodies, presence of anti-RNA polymerase III antibodies, higher age, forced vital capacity % predicted, and diffusing capacity of the lungs for carbon monoxide % predicted. In addition, the other covariates were assessed for confounding with a change-in-estimation model.Results:We identified 275 patients meeting the eligibility criteria, from which 90(33%) patients had an early scleroderma pattern, 135(49%) patients had an active scleroderma pattern, and 50(18%) patients had a late scleroderma pattern. Patients with a more severe nailfold capillaroscopic pattern (i.e. active or late) had an unfavourable disease phenotype (Table 1).In our cohort, 66(24%) of the patients developed ILD after a mean(SD) follow-up period of 2.2(1.2) years. The mixed regression model corrected for the a priori defined confounders as well as for modified Rodnan skin score revealed a rise in the annual risk for incident ILD with worsening severity of nailfold capillaroscopic pattern: OR(95%CI); 3.76(1.99-7.11, p<0.01 (Figure 1). Thus, these results indicate an increased risk for incident ILD after? a transition towards a deteriorating nailfold capillaroscopic pattern, along with a reduced risk for incident ILD when transitioning to an improved nailfold capillaroscopic pattern.Conclusion:In conclusion progression towards a more severe nailfold capillaroscopic pattern is associated with a higher risk to develop ILD, necessitating longitudinal nailfold capillaroscopic assessments to identify patients at risk in the early disease stage.REFERENCES:[1] Elhai M et al., Ann Rheum Dis. 2017;76(11):1897-905.[2] Smith V et al., Autoimmun Rev. 2020;19(9):102619.Acknowledgements:NIL.Disclosure of Interests:Arthiha Velauthapillai: None declared, C.H.M. van den Ende: None declared, Madelon Vonk Boehringer Ingelheim, GSK, Janssen, MSD, Novartis, Boehringer Ingelheim, Janssen, Unrestricted research grants from Boehringer Ingelheim, Ferrer and Galapagos.

Background The therapeutic efficacy and prognosis of various tumors can be assessed using the systemic immune-inflammatory index (SII) and prognostic nutritional index (PNI). Despite their potential, no studies have investigated the prognostic value of the combined SII-PNI score for outcomes in patients with extensive small cell lung cancer (ES-SCLC) treated with chemotherapy and immune checkpoint inhibitors (ICIs). Materials and methods Our study retrospectively examined 213 ES-SCLC patients treated with chemotherapy and ICIs across two institutions. The patients were divided into three groups based on their SII-PNI scores. Cox regression analysis was employed to identify independent prognostic factors. A nomogram was constructed based on these independent factors. With 1000 repeated samples, the bootstrap method was used to validate the nomogram model internally. The model’s performance was assessed using calibration curves, receiver operating characteristic (ROC) curves, and decision curve analysis (DCA). Result Before and after chemotherapy with immune checkpoint inhibitors (ICIs), SII was significantly higher in the PD group compared with the PR group (both p  < 0.05). In the meantime, PNI was considerably lower in the PD group than in the PR group (both p  < 0.01). Kaplan-Meier curves demonstrated that patients with a low SII-PNI had prolonged progression-free survival (PFS) and overall survival (OS) compared to those with a high SII-PNI (all p  < 0.01). Multivariate Cox analysis showed that PS = 1, bone metastasis, brain metastasis, and SII-PNI = 1,2 after four treatment cycles were independent risk factors for shorter OS and were included in the nomogram model. The ROC curves, C-index, and DCA curves confirm that the SII-PNI scores-based nomograms have strong predictive accuracy for OS. Conclusion There was a significant correlation between pre- and post-treatment SII-PNI and treatment effect in ES-SCLC. The SII-PNI score after four treatment cycles is a useful prognostic indicator for ES-SCLC patients receiving chemotherapy combined with immune checkpoint inhibitors (ICIs).

BackgroundFrailty, demographic and clinical variables linked to incident diseases (e.g., dehydration, inflammation) contribute to poor outcomes in older patients acutely hospitalized. Their predictivity on short-, intermediate- and long-term mortality in a comprehensive model has been scarcely investigated.AimsTo test the performance of a predictive tool considering frailty and inflammation as well as age, sex and impaired hydration status on 1-year mortality in acutely admitted older patients.MethodsRetrospective observational study including 529 medical patients (age 84.6 ± 7.3 years). At hospital admission, frailty was assessed by the Multidimensional Prognostic Index (MPI). The Glasgow Prognostic Score (GPS) was used to grade systemic inflammation. Serum osmolarity was calculated to assess hydration.ResultsAfter adjusting for age, sex, GPS and osmolarity, the severe-risk MPI was a strong predictor for 1-year mortality (OR 4.133; 95% CI 2.273–7.516; p < 0.001). Age > 85 years, male sex, GPS-2 and serum osmolarity > 300 mOsm/L were independent predictors of mortality in the same multivariable model. The MPI alone showed a moderate discrimination power (AUC 0.678; 95% CI 0.628–0.729; p < 0.001) on 1-year mortality, which increased by 12.5% after the addition of the above predictors in the fully adjusted regression model (AUC 0.763; 95% CI 0.719–0.807; p < 0.001). The severe-risk MPI adjusted for the same factors was also an independent predictor of mortality after 60 and 180 days since hospital admission.DiscussionInflammation and impaired hydration are potentially modifiable risk factors for severe outcomes in older acutely hospitalized patients. A model combining GPS, age, gender, and plasma osmolarity improved the accuracy of MPI at admission in predicting long-term mortality.

Background:In patients with Sjögren’s Syndrome (SS), the biopsy of minor salivary glands (MSG) is a fundamental diagnostic and prognostic tool. However, there is still variability in the histological parameters considered, and the clinical/laboratory associations are yet to be clarified.Objectives:Aim of this study is to investigate in a large monocentric cohort of primary SS patients (Sjogren Clinic at University of Rome Sapienza), the predictive value of MSG histology versus the main clinical, clinimetric and laboratory features.Methods:Primary SS patients undergoing MSG biopsy between 2016 and 2023 were retrospectively enrolled and the histological/clinical/clinimetric/laboratory data were collected. Histological analysis comprised: focus score (FS) and n° of foci calculation, germinal centers (GCs) [nodular aggregates (H&E), confirmed by CD21+ or Bcl6+ (IHC)] and lymphoepithelial lesions (LEL) (CD20+ IHC in ducts) detection and fibrosis (H&E) recognition. Logistic and linear regression analyses were performed to evaluate the predictive value of histology on clinical/clinimetric/laboratory parameters.Results:Two-hundred and thirty-two SS patients were enrolled [mean age 53.6 years (±13.6), F=223/M=9] (figure 1). Both the FS and the n° of foci were predictive of anti-La/SSB, RF, hypergammaglobulinemia and were positively correlated with the ESSDAI. Wile the FS was predictive for low C4 levels, the n° of foci was predictive for anti-Ro/SSA, monoclonal component, biologic and glandular ESSDAI domains. As we recently published [1], a lower FS and n° of foci was predictive for the presence of autoimmune thyroiditis. We found a large agreement between CD21+ and Bcl6+ staining. The presence of GCs (either CD21+ or Bcl6+) was predictive for those serological features associated with a more severe disease. GCs were also predictive of specific ESSDAI domains linked with higher risk of lymphoproliferative complications (Figure 1). Both the CD21+ and the Bcl6+ stainings were predictive of an higher ESSDAI score. Compared to GCs, LEL were even more predictive of different serological features and ESSDAI domains (Figure 1). Interestingly, the presence of fibrosis was associated with a lack of anti-Ro/SSA-La/SSB antibodies. Three patients developed MALT lymphoma; all of them had GCs (CD21+/Bcl6+) and LEL in their MSG biopsies, none had fibrosis [n° of foci: mean=8.3 (SD:5-13); FS mean=3.6 (SD=2.12-4.88)].Conclusion:This is one of the largest studies evaluating the predictive value of histology versus different clinical, clinimetric and laboratory parameters of patients with primary SS. Our data confirm the association between a higher FS and the presence of both serological features known to be linked to a more severe disease and higher ESSDAI score values. Compared to the FS, the number of foci revealed additional associations such as the biological and glandular ESSDAI domains. We confirm the association between GCs and those serological/clinical features accompanying a more systemic and active disease and we provide evidence of the same, and also additional associations, for the LEL. Finally, we demonstrate for the first time that the presence of fibrosis may be predictive of seronegative patients; this relevant finding, is currently under validation on a larger cohort.REFERENCES:[1] Colafrancesco S, et al. Clinical and histological features of patients with primary Sjögren’s syndrome and autoimmune thyroiditis: a national multicentre cross-sectional study. Clin Exp Rheumatol. 2023;41(12):2389-2396.Acknowledgements:NIL.Disclosure of Interests:None declared.

Background:TNFα and IL-23/IL-17 axis plays a pivotal role in the pathogenesis of axial spondyloarthritis (axSpA). Although inhibition of TNFα or IL-17 is a common treatment approach, long-term disease control is still often limited with these drugs. Reactivation of inflammation (clinical relapse) is frequently observed, and so far there is no definitive cure for axSpA using these treatments. Alternatively, the active stimulation of resolution of inflammation via activation of cytotoxic T-lymphocyte-associated Protein 4 (CTLA4) is a common treatment approach in e.g. rheumatoid arthritis. However, mechanisms that induce resolution of inflammation in axSpA are poorly understood. Recently, the heterogeneity of myeloid cells during the course of axSpA has been identified. While the immunoregulatory capacity of myeloid cells is well known from cancer and autoimmune diseases, their emergence, mechanisms of action, and therapeutic potential in axSpA remain unknown.Objectives:To investigate the role of regulatory myeloid cells in subsets of patients with radiographic axSpA.Methods:Axial inflammation was induced in Tg197 hTNFtg mice after hydrodynamic tail vein injection of IL-23 minicircle-DNA. CD11b+Ly6G+CXCR2-CD101- and CXCR2+CD101+ cells were flow-sorted and tested for suppressive function in T cell proliferation assays. Subsequently, results from mice were translated into humans. Peripheral blood was collected from 54 axSpA patients (ASDAS 2.02 ± 1.16) and 21 healthy controls. The abundance of CD66b+CXCR2-CD101-cells in the peripheral blood of active (n = 33) and inactive (n = 18; in inactive disease status according to ASDAS) axSpA patients and healthy controls was measured by flow cytometry. Biopsies from sacroiliac and facet joints of the lumbal spine were obtained from other 18 axSpA patients (BASDAI 5.2±1.4) and 8 non-inflammatory controls. The biopsies were taken under MRI (sacroiliac) or radiographic control (facet jonts) and immediately processed for imaging mass cytometry (IMC). IMC was performed with 37 validated antibodies for immunoprofiling as well as detecting resident mesenchymal cells.Results:IL-23 minicircle overexpression in 8 weeks old hTNFtg mice induced axial inflammation. Flow cytometric analyses of axial joints identified two main subtypes of neutrophils. While CXCR2+CD101+ neutrophils stimulated T cell proliferation,, sorted CXCR2-CD101- granulocytes from inflamed ankle joints exhibited potent immunosuppressive function in ex vivo T cell proliferation assays. Absolute numbers of CXCR2+CD101+ granulocytes increased after IL-23 overexpression, accompanied by a decrease in the CXCR2-CD101- to CXCR2+CD101+ ratio, indicating a local shift towards pro-inflammatory granulocytes. In r-axSpA patients, total neutrophil numbers, as well as CXCR2+CD101+ granulocytes, were significantly increased compared to healthy controls, independent of disease activity. In contrast, patients in clinical remission (as assessed by ASDAS) showed an increase of circulating CXCR2-CD101- granulocytes. To investigate the role of CXCR2-CD101- granulocytes at sites of inflammation in axSpA patients, we performed MRI guided biopsies of sacroiliac and facet joints of the lumbal spine. Immunoprofiling via IMC revealed a complex microenvironment of innate (innate lymphoid cells (ILCs), granulocytes) and adaptive immune cells (B and T cells) embeded in a mesenchymal network of fibroblasts and endothelial cells. Herein, CXCR2-CD101- immunoregulatory granulocytes particularly colocalized with pro-resolving ILC2s, suggesting their immuno-regulatory capacity.Conclusion:Our study established the existence of immunoregulatory CXCR2-CD101- granulocytes in axSpA. Their ability to inhibit T cell proliferation in vitro, along with their colocalization with pro-resolving immune cells at inflamed joints of axSpA patients, underscores their relevance in the pathophysiology of axSpA. Moreover, the negative correlation with disease activity suggests their potential as biomarkers and therapeutic targets in future treatment strategies.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of Interests:None declared.

Background:We recently reported that 2.7% of rheumatoid arthritis (RA) cases were polyrefractory (failure/tolerance of all b/tsDMARD classes). However, 40% of D2T-RA patients including polyrefractory RA (PFRA), lacked objective joint inflammation signs on ultrasound (US)- termed non-inflammatory refractory RA (NIRRA) whilst the remaining cases had US determined persistent inflammatory refractory RA (PIRRA). [1] EULAR suggests that rapid radiographic progression (radiographic progression above 5 units per year according to the modified Sharp/van Der Heijde scoring system) may be useful for defining D2T-RA.Objectives:We audited the use of x-rays for potential added value in D2T-RA to PFRA.Methods:Radiographic progression was evaluated at 2 timepoints in EULAR defined D2T RA and compared to PFRA group (failed 4 or 5 therapies depending on autoantibody status). Both hands and feet images were scored using the modified Sharp/van Der Heijde scoring system blinded to the time of radiography. Annual radiographic progression was compared between PIRRA (PDUS+) and NIRRA (PDUS-) subgroups. Annual CRP levels were calculated using the area under the curve method and furthermore annualized due to heterogeneous follow-up periods to capture the cumulative burden of inflammation.Results:Of 247 D2T-RA patients, 102 had hands radiographs at two timepoints (mean age (SD): 60.6 (13) years, mean disease duration: 190.4 month (SD 55.7) and F/M rate n: 83/19) and 67 of these 102 patients had both hands and feet radiographs. 102 patients with an interval of mean (SD): 107.1 (48.4) months between two x-rays, a seropositivity (RF or ACPA+) rate of 76.5% (n=78) and a PFRA rate of 39.2% (n=40) were included in the final analysis. The mean annual hands radiographic progression rate for the D2T-RA population was 2.2 (SD 2.67) units and mean annual feet radiographic progression rate was 0.7 (SD 0.98). Of the 67 patients with both hands/ feet radiographs, 15 (22.4%) had rapid progression rate defined in the EULAR D2T-RA. No difference between progression in the PFRA versus other D2T patients existed.The US determined PIRRA/NIRRA ratio as 54 (88.5%)/7 (11.5%) in patients with clinically swollen joints, and the rate of hands radiographic progression in PIRRA patients was statistically significantly higher than in NIRRA patients. (p=0.005) (Table 1). In correlation analysis, time-integrated yearly CRP level was correlated with the annual hand radiographic progression rate (r=0.425, p<0.001) (Table 1). No statistically significant correlation was found between the number of clinically swollen joints and the progression rate of either the hands or the feet (Table 1).Conclusion:This study assessed which clinical factors, including ultrasound findings, were associated with radiographic progression in D2T and PFRA patients. The radiographic progression rates in D2T to PFRA are low in the majority of RA cases and don’t differ between groups suggesting not intrinsically more destructive phenotype in PFRA. Time integrated yearly CRP levels were the best predictor of radiographic progression. Classifying as PIRRA subgroup on PDUS in patients with clinically SJC also associated with radiographic progression. In D2T-RA patients, low CRP levels and lack of PD on US may predict a lower rate of radiographic progression, even with refractory disease.REFERENCES:[1] David P, Di Matteo A, Hen O, Dass S, Marzo-Ortega H, Wakefield RJ, Bissell LA, Nam J, Mankia K, Emery P, Saleem B, McGonagle D. Poly-refractory Rheumatoid Arthritis: An Uncommon Subset of Difficult to Treat Disease with Distinct Inflammatory and Non-inflammatory Phenotypes. Arthritis Rheumatol. 2023 Dec 7. doi: 10.1002/art.42767. Epub ahead of print. PMID: 38059326.Acknowledgements:NIL.Disclosure of Interests:Kerem Abacar Amgen Partner Fellowship Program, Andrea Di Matteo: None declared, Paula David: None declared, Shouvik Dass: None declared, Paul Emery Abbvie, Gilead, Lilly and Novartis, AbbVie, BMS, Lilly and Samsung, BMS, AbbVie, MSD, Pfizer, Novartis and Roche, Benazir Saleem: None declared, Dennis McGonagle Janssen, Novartis, Lilly, Pfizer, UCB, Celgene, BMS, Janssen, Novartis, Lilly, Pfizer, UCB, Celgene, BMS, Janssen, Novartis, Lilly, Pfizer, UCB, Celgene, BMS.

To evaluate the prognostic significance of the modified Naples Prognostic Score (mNPS) in patients with locally advanced non-small cell lung cancer (NSCLC) after neoadjuvant chemotherapy and surgery. We conducted 126 patients with locally advanced NSCLC who were surgically treated at the Affiliated Hospital of Shandong Second Medical University from September 2012 to April 2019. According to the albumin, cholesterol, neutrophil-to-lymphocyte ratio (NLR), and lymphocyte-to-monocyte ratio (LMR) before neoadjuvant chemotherapy, mNPS was divided into separate Groups: Group 0, Group 1, and Group 2. The Kaplan-Meier method was used to analyze survival curves according to mNPS. Univariate and multivariate Cox analyses of overall survival (OS) and progression-free survival (PFS) were then conducted. Based on the mNPS system, the three Groups were defined as follows: Group 0, 20(15.9%) patients; Group 1, 85(67.5%) patients; and Group 2, 21(16.7%) patients. MNPS had a higher predictive value for OS (AUC = 0.640, P = 0.007) and PFS (AUC = 0.623, P = 0.024). Univariate analysis showed that clinical stage (P = 0.004), KPS score (P = 0.003), and surgical method (P = 0.042) were significantly correlated with OS. Clinical stage (P = 0.005), KPS score (P = 0.002), and mNPS (Group 2 vs Group 0, P = 0.002; Group 1 vs Group 0, P = 0.010) were significantly associated with PFS. Based on the positive results of univariate analyses, we performed multivariate analysis. Multivariate Cox Regression showed that clinical stage (P = 0.022), KPS score (P = 0.017), and mNPS (Group 2 vs Group 0, P = 0.008; Group 1 vs Group 0, P = 0.038) were independent prognostic factors for PFS. MNPS was an independent prognostic factor for PFS in patients with locally advanced non-small cell lung cancer undergoing surgery after neoadjuvant chemotherapy, but it was not an independent prognostic factor for OS. Comparatively, NPS had a higher significance in predicting the prognosis of resected locally advanced NSCLC patients receiving neoadjuvant chemotherapy and surgery.

Background. Pediatric-onset Sjögren’s disease (pSjD) presents distinct clinical and serological features compared with the adult form (SjD). While adults more frequently exhibit sicca symptoms such as xerophthalmia and xerostomia, parotid swelling and cutaneous involvement are the most common clinical manifestations in pSjD. From a serological perspective, pediatric patients less frequently test positive for ANA and anti-SSA/SSB antibodies but tend to show higher levels of rheumatoid factor (RF). The aim of this study was to compare the histopathological characteristics of minor salivary gland (MSG) biopsies between pediatric and adult patients with SjD.   Materials and Methods. The study included 18 consecutive patients with pSjD followed at an Italian pediatric rheumatology center and 54 consecutively evaluated adult SjD patients from an adult rheumatology unit. All biopsy samples were examined by an expert pathologist at each site according to the EULAR recommendations for standardized histopathological assessment of minor salivary gland biopsies.   Results. The surface area of biopsy specimens did not differ significantly between the two groups (p = 0.551). Pediatric patients displayed significantly higher focus scores (p = 0.0227) and a greater prevalence of ectopic germinal centers, as evidenced by increased CD21 (52.94% vs. 16.22%, p = 0.005) and Bcl6 expression (47.06% vs. 8.11%, p = 0.0011). Lymphoepithelial lesions were also more frequent in the pediatric cohort (55.56% vs. 18.92%, p = 0.0065), as was fibrosis (66.67% vs. 29.73%, p = 0.031). No significant differences were observed for glandular atrophy (p = 0.687) or ductal dilation (p = 0.128). When stratified by disease onset relative to menarche, prepubertal-onset patients exhibited a higher frequency of germinal centers and lymphoepithelial lesions than those with postpubertal-onset disease (p < 0.05).   Conclusions. This study represents the first direct histopathological comparison of minor salivary gland biopsies between pediatric and adult patients with Sjögren’s disease. The findings confirm a more pronounced inflammatory pattern in pediatric patients, consistent with the higher clinical activity observed in this population. In particular, the increased frequency of ectopic germinal centers and lymphoepithelial lesions in prepubertal-onset cases suggests the possible involvement of age-dependent immunopathogenic mechanisms underlying early-onset pSjD. These results reinforce the pivotal role of minor salivary gland biopsy not only in diagnosis but also in disease prognostication, emphasizing the importance of early recognition and close clinical monitoring in pediatric patients.

Abstract Objectives To evaluate the prognostic significance of lymphovascular invasion (LVI) for patients with gastric cancer (GC). Methods A total of 1,720 consecutive patients who underwent curative gastrectomy were retrospectively identified. The association between LVI and clinicopathologic characteristics was determined and its impact on survival outcome was evaluated. Results LVI was detected in 21.3% of GC patients, 5.9% of patients with early GC, 24.0% of patients with advanced GC, and 6.7% of node-negative patients using H&E staining. Tumor size (odds ratio [OR], 1.509; 95% confidence interval [CI], 1.159-1.965; P < .01), differentiated type (OR, 1.817; 95% CI, 1.377-2.398; P < .001), and the depth of tumor invasion (OR, 3.011; 95% CI, 2.174-4.171; P < .001) were independent predictive factors for LVI. LVI-positive patients have a poorer prognosis than LVI-negative patients, irrespective of tumor stage or lymph node metastasis. LVI was an independent prognostic factor for patients with GC (hazard ratio, 1.299; 95% CI, 1.112-1.518; P < .001). Conclusions LVI provided additional prognostic information for GC patients, and LVI-positive patients should be considered candidates for adjuvant chemotherapy.

The reporting of machine learning (ML) prognostic and diagnostic modeling studies is often inadequate, making it difficult to understand and replicate such studies. To address this issue, multiple consensus and expert reporting guidelines for ML studies have been published. However, these guidelines cover different parts of the analytics lifecycle, and individually, none of them provide a complete set of reporting requirements. We aimed to consolidate the ML reporting guidelines and checklists in the literature to provide reporting items for prognostic and diagnostic ML in in-silico and shadow mode studies. We conducted a literature search that identified 192 unique peer-reviewed English articles that provide guidance and checklists for reporting ML studies. The articles were screened by their title and abstract against a set of 9 inclusion and exclusion criteria. Articles that were filtered through had their quality evaluated by 2 raters using a 9-point checklist constructed from guideline development good practices. The average κ was 0.71 across all quality criteria. The resulting 17 high-quality source papers were defined as having a quality score equal to or higher than the median. The reporting items in these 17 articles were consolidated and screened against a set of 6 inclusion and exclusion criteria. The resulting reporting items were sent to an external group of 11 ML experts for review and updated accordingly. The updated checklist was used to assess the reporting in 6 recent modeling papers in JMIR AI. Feedback from the external review and initial validation efforts was used to improve the reporting items. In total, 37 reporting items were identified and grouped into 5 categories based on the stage of the ML project: defining the study details, defining and collecting the data, modeling methodology, model evaluation, and explainability. None of the 17 source articles covered all the reporting items. The study details and data description reporting items were the most common in the source literature, with explainability and methodology guidance (ie, data preparation and model training) having the least coverage. For instance, a median of 75% of the data description reporting items appeared in each of the 17 high-quality source guidelines, but only a median of 33% of the data explainability reporting items appeared. The highest-quality source articles tended to have more items on reporting study details. Other categories of reporting items were not related to the source article quality. We converted the reporting items into a checklist to support more complete reporting. Our findings supported the need for a set of consolidated reporting items, given that existing high-quality guidelines and checklists do not individually provide complete coverage. The consolidated set of reporting items is expected to improve the quality and reproducibility of ML modeling studies.