ABSTRACT
BackgroundPatients with rheumatic diseases may present more severe SARS-CoV-2 infection compared to the general population. However, in some studies, hospitalization and mortality due COVID-19 were lower in patients with axial spondyloarthritis (axSpA) compared to other rheumatic diseases.ObjectivesTo assess the severity of SARS-CoV-2 infection in patients with axSpA from the SAR-COVID registry, comparing them with patients with rheumatoid arthritis (RA), and to determine the factors associated with poor outcomes and death.MethodsPatients ≥18 years old from the SAR-COVID national registry with diagnosis of AxSpA (ASAS criteria 2009) and RA (ACR/EULAR criteria 2010) who had confirmed SARS-CoV-2 infection (RT-PCR or positive serology), recruited from August 2020 to June 2022 were included. Sociodemographic and clinical data, comorbidities, treatments and outcomes of the infection were collected. Infection severity was assessed using the WHO-ordinal scale (WHO-OS)[1]: ambulatory [1], mild hospitalizations (2.3 y 4), severe hospitalizations (5.6 y 7) and death [8].Statistical analysisDescriptive statistics. Chi[2] or Fischer test and Student T or Mann-Whitney as appropriate. Poisson generalized linear model.ResultsA total of 1226 patients were included, 59 (4.8%) with axSpA and 1167 (95.2%) with RA. RA patients were significantly older, more frequently female, and had a longer disease duration. More than a third of the patients were in remission. 43.9 % presented comorbidities, arterial hypertension being the most frequent. At the time of SARS-Cov-2 diagnosis, patients with RA used glucocorticoids and conventional DMARDs more frequently than those with axSpA, while 74.6% of the latter were under treatment with biological DMARDs being anti-TNF the most used (61%).94.9 % of the patients in both groups reported symptoms related to SARS-CoV-2 infection. Although the differences were not significant, patients with RA presented more frequently cough, dyspnea, and gastrointestinal symptoms, while those with axSpA reported more frequently odynophagia, anosmia, and dysgeusia. During the SARS-CoV-2 infection, 6.8% and 23.5% of the patients with axSpA and RA were hospitalized, respectively. All of the patients with axSpA were admitted to the general ward, while 26.6% of those with RA to intensive care units. No patient with axSpA had complications or severe COVID-19 (WHO-OS>=5) or died as a result of the infection while mortality in the RA group was 3.3% (Figure 1).In the multivariate analysis adjusted to poor prognosis factors, no association was found between the diagnosis of axSpA and severity of SARS-CoV-2 infection assessed with the WHO-OS (OR -0.18, IC 95%(-0.38, 0.01, p=0.074).ConclusionPatients with EspAax did not present complications from SARS-CoV-2 infections and none of them died due COVID-19.Reference[1]World Health Organization coronavirus disease (COVID-19) Therapeutic Trial Synopsis Draft 2020.Figure 1.Outcomes and severity of SARS-CoV-2 infection in patients with axSpA and RA.[Figure omitted. See PDF]Acknowledgements:NIL.Disclosure of InterestsAndrea Bravo Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Tatiana Barbich Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Carolina Isnardi Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretati n, or writing the report. They do not have access to the information collected in the database., Gustavo Citera Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Emilce Edith Schneeberger Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Rosana Quintana Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Cecilia Pisoni Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Mariana Pera Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Edson Velozo Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Dora Aida Pereira Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Paula Alba Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Juan A Albiero Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Jaime Villafañe Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Hernan Maldonado Ficco Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Veronica Sa io Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Santiago Eduardo Aguero Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Romina Rojas Tessel Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Maria Isabel Quaglia Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., María Soledad Gálvez Elkin Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access tothe information collected in the database., Gisela Paola Pendon Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Carolina Aeschlimann Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Gustavo Fabian Rodriguez Gil Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Malena Viola Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Cecilia Romeo Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Carla Maldini Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Silvana Mariela Conti Grant/research support from: SAR-COVID is a multi-sponsor re istry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Rosana Gallo Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Leticia Ibañez Zurlo Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Maria Natalia Tamborenea Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Susana Isabel Pineda Vidal Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Debora Guaglianone Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Jonatan Marcos Mareco Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Cecilia Goizueta Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Elisa Novatti Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Fernanda Guzzanti Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Gimena Gómez Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Karen Roberts Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of t em participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Guillermo Pons-Estel Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database.
ABSTRACT
Objectives: To describe the clinical characteristics and outcomes of SARSCoV-2 infection in patients with systemic vasculitis. Method(s): Observational, multicenter, cross-sectional analytical study in patients 18 or older diagnosed with systemic vasculitis with confirmed SARSCoV-2 infection (RT-PCR or serology) included in the SAR-COVID registry. Patients were evaluated from July 2020 to February 2022. Patients diagnosed with ANCA-associated vasculitis (AAV), other systemic vasculitides (Giant cell arteritis, Takayasu), and a control group of patients with other rheumatological diseases matched by age, sex, comorbidities, and date of SARS-CoV-2 infection. The survival curve of the groups was studied by Kaplan-Meier and compared through the Log-Rank Test. A Cox regression model will be performed to adjust survival for different variables (sex, age, treatments for underlying disease, treatments for viral infection, smoking, obesity, d-dimer level, and disease activity). Result(s): A total of 282 out of 2694 patients in the SAR-COVID registry were included, 57.4%women with a mean age of 55.7 years (SD 14.1). Fifty-four patients in the AAV group, 32 in the other vasculitis group, and 196 controls were studied. Hospitalization was required in 53.7% of the AAV group, 37.5% in other vasculitides, and 26.2% in the control group. 5.6% of patients in the control group presented acute respiratory distress syndrome (ARDS), 15.6% in the other vasculitis group, and 22.2% in the AAV group (p alpha 0.001). Complete recovery was observed in 82.3% of patients in the control group, 75%in the other vasculitis group, and 63%in the AAV group.We observed that 5.7% of the patients in the control group died from COVID-19, 9.4%from other vasculitides, and 27.8% in the AAV group (p alpha 0.001). We found a lower survival in the AAV group compared to the control group (p alpha 0.005). In the multivariate Cox regression model, older age (HR:1.05 IC95%1.01-1.09 p = 0.01), BMI > 40 (HR:13.2 IC95% 2.1-83.2 p = 0.01), and high activity of the underlying disease (HR:16 95% CI 3.7-69.4 p alpha 0.005) were associated with lower survival. Conclusion(s): In conclusion, patients diagnosed with AAV presented a worse disease course during SARS-CoV-2 infection with a more frequent requirement for invasive mechanical ventilation. Likewise, these patients showed lower survival compared to patients with other autoimmune diseases.
ABSTRACT
Background: High disease activity, treatment with glucocorticoids (GC) and rituximab (RTX), have been related to worse outcomes of COVID-19. Objectives: To assess the clinical characteristics and severity of the SARS-CoV-2 infection in patients with rheumatoid arthritis (RA) included in the SAR-COVID registry and to identify factors associated with poor outcomes. Methods: SAR-COVID is a national, longitudinal and observational registry. Patients of ≥18 years old, with diagnosis of RA (ACR-EULAR criteria 2010) who had confrmed SARS-CoV-2 infection (RT-PCR or positive serology) were included between 13-8-20 and 31-7-21. Sociodemographic and clinical data, comorbidities, disease activity and treatment at the moment of the SARS-CoV-2 infection were collected. Additionally, infection symptoms, complications, medical interventions and treatments for COVID-19 were registered. Infection severity was assessed using the WHO-ordinal scale (WHO-OS)1. A cut-off value of ≥5 identifed patients with severe COVID-19 and those who died. Statistical analysis: Descriptive statistics. Chi2 or Fischer test, Student T test or Mann-Whitney and Kruskal Wallis or ANOVA, as appropriate. Multiple logistic regression model. Results: A total of 801 patients were included, with a mean age of 53.1 ± 12.9 years, most of them were female (84.5%) and the median (m) disease duration was 8 years (IQR 4-14). One third were in remission and 46.4% had comor-bidities, being the most frequent, hypertension (26.9 %), dyslipidemia (13.5 %), obesity (13.4 %) and diabetes (8.9%). Moreover, 3.2% had interstitial lung disease (ILD) associated with RA. At SARS-CoV-2 diagnosis, 42.5% were receiving glucocorticoids (GC), 73.9% conventional (c) disease modifying antirheumatic drugs (DMARD), 24% biologic (b) DMARD and 9.1% targeted synthetic (ts) DMARD. Among bDMARD, the most frequently used were TNF inhibitors (17%), followed by abatacept (2.8%), IL-6 inhibitors (2.4%) and rituximab (RTX) (2.1%). During the SARS-CoV-2 infection, 95.8% had symptoms, 27% required hospital-ization, 7.9% presented complications and 4.4% died due to COVID-19. Severe disease and death (WHO-OS≥5) was present in 7.5% of the patients. They were older (62.9±12.5 vs 52.2±12.7, p<0.001), and they had more frequently ILD (18.5% vs 2%, p<0.001), comorbidities (82.5% vs 43.7%, p<0.001), ≥2 comor-bidities (60.3% vs 25.8%, p<0.001), treatment with GC (61% vs 40.7%, p=0.04) and RTX (8.3% vs 1.6%, p=0.007). Conversely, the use of cDMARD and TNF inhibitors was more frequent in patients with WHO-OS<5, nevertheless this difference was not signifcant. Disease activity was comparable between groups. In multivariable analysis, older age, the presence of diabetes, ILD, the use of GC and RTX were signifcantly associated with WHO-OS≥5 (Figure 1). Furthermore, older age (65.7±10.8 vs 52.4±12.8, p<0.001), the presence of comor-bidities (87.9% vs 44.7%, p<0.001), chronic obstructive pulmonary disease (21.9% vs 5.2%, p=0.002), diabetes (30.3% vs 7.9%, p<0.001), hypertension (57.6% vs 25.6%, p<0.001), cardiovascular disease (15.6% vs 3.2%, p=0.005), cancer (9.1% vs 1.3%, p=0.001), ILD (23.3% vs 2.4%, p<0.001) and the use of GC (61.8% vs 41.4%, p=0.02) were associated with mortality. Older age [OR 1.1 IC95% 1.06-1.13] and the use of GC 5-10 mg/day [OR 4.6 IC95% 1.8-11.6] remained signifcantly associated with death due to COVID-19. Conclusion: Treatment with RTX and GC, as well as older age, the presence of diabetes and ILD were associated with poor COVID-19 outcomes in this national cohort of patients with RA. Older patients and those taking GC had a higher mortality rate.
ABSTRACT
Background: Persistent symptoms after acute COVID have been described previously. Main symptoms reported are fatigue, arthralgias, myalgias and mental sickness. Defnition and methods vary widely.1 Objectives: To asses prevalence and related factors to long COVID in a retrospective cohort of patients with rheumatic diseases from Argentina. Methods: A total of 1915 patients were registered from August 18th, 2020 to July 29th, 2021. Patients > 18 years old, with rheumatic disease and confrmed infection by SARS-CoV-2 (antigen or RT-PCR) were included. Those dead, with unknown outcome, wrong date or missing data were excluded. Demographic data, comorbidities, rheumatic disease, and characteristics of SARS-CoV-2 infection were recorded. Long COVID was defned according to NICE guidelines (persistent symptoms for more than 4 weeks, without alternative diagnosis). Long COVID symptoms were defned by rheumatologist. Severity of infection was clas-sifed according to WHO ordinal scale. We used descriptive statistics, univariate model (Student's test, chi square test, ANOVA) and multivariate logistic regression analysis. Results: 230 (12%) had long COVID. Median age was 51 (IQR 40-61]) years, 82% were females, 51% were not caucasian. Median of education was 13.3 years (IQR 12-16), 79 % had private health insurance and 55 % were employed. Nearly half (n=762, 46%) had comorbidities, the most prevalent was hypertension (n=396, 24%). The most frequent rheumatic diseases were rheumatoid arthritis (n=719, 42%) and systemic lupus ery-thematosus (n=280, 16 %). Most were in low activity/remission (79%), used Conventional DMARD (n=773 patients, 45%) and steroids (n=588, 34%) at low dose (n=415, 71%). Main laboratory findings were abnormal D-di-mer (n=94, 28%) and leukopenia (n=93, 26%). Most patients had a WHO ordinal scale < 5 (n=1472, 86%). Median of hospitalization at intensive care unit (ICU) was 8 days [IQR 5, 13]. Treatment for SARS-CoV-2 infection (steroids, anticoagulation, azithromycin, convalescent plasma) was used in 461 (27%) patients. Most of long COVID (n= 152, 69%) reported 1 symptom, the most frequent was fatigue (n= 55, 22%). Figure 1. Univariate analysis is presented in Table 1. In multivariate logistic regression analysis non-caucasian ethnicity OR 1.44 (1.07-1.95), years of education OR 1.05 (1-1.09), treatment with cyclophosphamide OR 11.35 (1.56-112.97), symptoms of COVID-19 OR 13.26 (2.75-242.08), severity scale WHO ≥ 5 OR 2.46 (1.68-3.57), and ICU hospitalization days OR 1.09 (1.05-1.14) were factors associated to long COVID. Conclusion: Prevalence of long COVID was 12%. Non-caucasian ethnicity, higher education, treatment with cyclophosphamide, symptoms of COVID-19, severe disease and ICU hospitalization days were related to long COVID.
ABSTRACT
Objectives: To compare characteristics of patients with rheumatic disease and COVID-19 in Argentina (SAR-COVID Registry), in contrast to the data reported at the Latin American and global level (Global International Alliance RheumCOVID Registry). Methods: A national, multicenter, longitudinal and observational registry was carried out. Patients older than 18 years, with a diagnosis of rheumatic disease and SARS-CoV-2 infection by PCR or positive serology, were included between August 13, 2020 and April 11, 2021. Demographic data, underlying rheumatic disease, comorbidities, clinical-laboratory characteristics of the SARS-CoV-2 infection, as well as treatments and outcomes. Characteristics of the patients included were compared with the data reported at the Latin American and global level. Descriptive statistics were performed. Comparisons between groups were made using ANOVA, chi2 or Fisher's test. Results: 863 patients from Argentina, 74 patients from Latin America and 583 from the rest of the world were included, mostly women in the three groups (79.4%, 73% and 71% respectively). The most frequent rheumatic diseases in the three groups were rheumatoid arthritis (45.8%, 35%, and 39%, respectively) and systemic lupus erythematosus (18%, 22%, and 14%) (Table 1). In Argentina, fewer patients received specific pharmacological treatment for COVID-19 in relation to the other 2 groups (41.4%, 68% and 43% respectively, p < 0.0001), and there was a lower requirement for non-invasive/invasive mechanical ventilation than in the rest of Latin America and theworld (8.6%vs 31% vs 13%, p < 0.0001). Hospitalization requirement in Argentina was lower than in the rest of Latin America and the rest of theworld (32.8%vs 61% vs 45%, p < 0.0001), as well as mortality (5.8%, 12%and 11%;p 0.0010). 86.9% of patients did not present any complications in Argentina, with a statistically significant difference with the rest of the groups (62% and 77%, with p < 0.0001) (Figure 1). Conclusion: Patients with rheumatic diseases and SARS-CoV-2 infection from Argentina reported in this registry received less specific pharmacological treatment for COVID-19 than those registered in other countries, presented fewer complications and required less ventilatory support. In relation to mortality, although a lower mortality was found in the Argentine registry. The fact that registries have information collected at different periods of the pandemic and different local epidemiological situations, does not allow major conclusions to be drawn.