Descriptive statistics were used to present the patients’ characteristics and clinical parameters with mean ± standard deviation or frequency. The chi-square test was employed for frequency data, presented as n and %.
The threshold for anemia was hemoglobin < 12 g/dl in female patients and < 13 g/dl in male patients. ID was defined by the threshold for ferritin as < 30 ng/ml with normal levels of CRP and ferritin < 100 ng/ml with CRP levels > 5 mg/l. The reference cutoffs were based on reference ranges that were either previously established by clinical research or taken from the local laboratory.
The relevance for survival was investigated for clinical parameters associated with outcome in SSc including sex, age, type of SSc, presence of ILD [15 (link)], DLCO ≤ 65% predicted [5 (link)], and PVR ≥ 2 WU [10 (link)]. Furthermore, parameters associated with iron metabolism or inflammation including CRP and white blood cell count were compared between the groups. The Mann-Whitney U test was employed to compare the clinical characteristics between the patient groups with HRC > 2% and ≤ 2%.
The prognostic values for survival were investigated by uni- and multivariable Cox regression analysis. Death due to any cause, date of lung transplantation, or date of last contact was recorded for survival at follow-up and compared to the time of the first evaluation (baseline). Univariable categorial analysis was performed by Kaplan-Meier analysis. A multivariable Cox model was performed including all variables, which were significantly associated with survival (p < 0.05) in the univariable log rank tests. The combined independent parameters for risk assessment were compared with known risk stratification tools REVEAL [16 (link)], REVEAL 2.0 [17 (link)], COMPERA [18 ], and the French risk assessment strategy [19 ]. p-values < 0.05 were considered as statistically significant. IBM SPSS V 27.0 was used to conduct all analyses (IBM Corp. Released 2020. IBM SPSS Statistics for Macintosh, version 27.0. Armonk, NY: IBM Corp.).
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