Routine Use of Immunosuppressants is Associated with Mortality in Hospitalised Patients with COVID-19

Abstract Background: Whilst there is literature on impact of the SARS viruses in the severely immunosuppressed, and those who develop exaggerated immune response, less is known about the link between routine immunosuppressant use and outcome in COVID-19. Consequently, guidelines on their use vary depending on specific patient populations.Methods: The study population was drawn from the COPE Study (COVID-19 in Older People), a multicentre observational cohort study, carried out in UK and Italy. Data were collected between 27th February and 28th April 2020 by trained data collectors and included all unselected consecutive admissions with Covid-19. Load (name/number of medications) and dosage of immunosuppressant were collected along with other covariate data. The primary outcome was time-to-mortality from the date of admission (or) date of diagnosis, if diagnosis was five or more days after admission. Secondary outcomes were Day-14 mortality and time-to-discharge (length of stay). Data were analysed with mixed-effects, Cox proportional hazards and Logistic regression models using non-users of immunosuppressants as the reference group.Results: 1184 patients were eligible for inclusion. The median (IQR) age was 74(62-83), 676(57%) were male, and 299(25.3%) died in hospital (total person follow-up 15,540 days). Most patients exhibited at least one comorbidity, and 113(~10%) were on immunosuppressants. We found that any immunosuppressant use was associated with increased mortality: aHR 1.87,95%CI:1.30,2.69 (time to mortality) and aOR1.71,95%CI:1.01-2.88 (14-day mortality). There also appeared to be a dose-response relationship.Conclusion: Despite the possibility of indication bias, until further evidence emerges we recommend adhering to public health measures stringently, a low threshold to seek medical advice and close monitoring of worsening symptoms in those who take immunosuppressants routinely regardless of their indication.

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Risk factors for severe disease in patients admitted with COVID-19 to a hospital in London, England: a retrospective cohort study

Epidemiology and Infection ◽

10.1017/s0950268820002472 ◽

2020 ◽

Vol 148 ◽

Author(s):

J. W. Goodall ◽

T. A. N. Reed ◽

M. Ardissino ◽

P. Bassett ◽

A. M. Whittington ◽

...

Keyword(s):

Risk Factors ◽

Cohort Study ◽

Proportional Hazards ◽

Severe Disease ◽

Cox Proportional Hazards ◽

Reactive Protein ◽

Global Pandemic ◽

Northwick Park Hospital ◽

Hospitalised Patients ◽

Observational Cohort

Abstract COVID-19 has caused a major global pandemic and necessitated unprecedented public health restrictions in almost every country. Understanding risk factors for severe disease in hospitalised patients is critical as the pandemic progresses. This observational cohort study aimed to characterise the independent associations between the clinical outcomes of hospitalised patients and their demographics, comorbidities, blood tests and bedside observations. All patients admitted to Northwick Park Hospital, London, UK between 12 March and 15 April 2020 with COVID-19 were retrospectively identified. The primary outcome was death. Associations were explored using Cox proportional hazards modelling. The study included 981 patients. The mortality rate was 36.0%. Age (adjusted hazard ratio (aHR) 1.53), respiratory disease (aHR 1.37), immunosuppression (aHR 2.23), respiratory rate (aHR 1.28), hypoxia (aHR 1.36), Glasgow Coma Scale <15 (aHR 1.92), urea (aHR 2.67), alkaline phosphatase (aHR 2.53), C-reactive protein (aHR 1.15), lactate (aHR 2.67), platelet count (aHR 0.77) and infiltrates on chest radiograph (aHR 1.89) were all associated with mortality. These important data will aid clinical risk stratification and provide direction for further research.

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The challenge of managing severe delirium: an observational study of the effects of pharmacological and supportive care on delirium duration and resolution in 602 patients

10.21203/rs.2.18810/v1 ◽

2019 ◽

Author(s):

Carl Moritz Zipser ◽

Peter Hayoz ◽

Silvana Knöpfel ◽

Peter Peyk ◽

Maria Schubert ◽

...

Keyword(s):

Clinical Practice ◽

Supportive Care ◽

Proportional Hazards ◽

Dual Therapy ◽

Estimating Equation ◽

Cox Proportional Hazards ◽

Routine Clinical Practice ◽

Hospitalised Patients ◽

Observational Cohort ◽

Management Approaches

Abstract Background: Delirium is the most common neuropsychiatric disorder seen in hospitalised patients. Current guidelines recommend only using antipsychotics with distressed patients. Nonetheless, in routine clinical practice, multiple psychotropics are commonly administered. More evidence on the short-term benefits of various management approaches in patients with delirium is required. Methods: In this observational cohort study, 602 delirious patients were followed for twenty days. Supportive care was provided to all patients in addition to either no psychotropic therapy, monotherapy, dual therapy, or polytherapy defined as three or more psychotropic drugs. The effectiveness of interventions regarding delirium resolution and symptom severity was determined by Cox proportional hazards regression and generalized estimating equation models. Results: Psychotropics were commonly used to manage delirium. In total, 12.1% of patients received polytherapy, 37.2% dual therapy, 37.7% monotherapy, and 12.1% supportive care alone (i.e., almost half of the patients received ≥ two psychotropics). Patients who received polytherapy had higher initial baseline delirium severity and exposed the mixed subtype more often; with the latter delirium lasted longer and recovery was less frequent than in mild delirium. Providing supportive care alone in mild delirium was superior to all psychotropic approaches. Conclusions: In routine clinical practice, the use of multiple psychotropics is common. In our study, however, despite combined supportive management and polypharmacy, patients with severe delirium suffer longer from delirium and have lower resolution rates. For the management of patients with mild delirium supportive care alone can be considered. When psychotropics are considered, single psychotropics and dose optimisation are recommended. These findings underline the challenge of managing severe delirium.

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Are there sex differences among colorectal cancer patients in treatment and survival? A Swiss cohort study

Journal of Cancer Research and Clinical Oncology ◽

10.1007/s00432-021-03557-y ◽

2021 ◽

Vol 147 (5) ◽

pp. 1407-1419

Author(s):

Manuela Limam ◽

Katarina Luise Matthes ◽

Giulia Pestoni ◽

Eleftheria Michalopoulou ◽

Leonhard Held ◽

...

Keyword(s):

Colorectal Cancer ◽

Regression Models ◽

Proportional Hazards ◽

Treatment Decision ◽

Tumor Stage ◽

Primary Treatment ◽

Cox Proportional Hazards ◽

Men And Women ◽

Logistic Regression Models ◽

Comorbidity Index

Abstract Background Colorectal cancer (CRC) is among the three most common incident cancers and causes of cancer death in Switzerland for both men and women. To promote aspects of gender medicine, we examined differences in treatment decision and survival by sex in CRC patients diagnosed 2000 and 2001 in the canton of Zurich, Switzerland. Methods Characteristics assessed of 1076 CRC patients were sex, tumor subsite, age at diagnosis, tumor stage, primary treatment option and comorbidity rated by the Charlson Comorbidity Index (CCI). Missing data for stage and comorbidities were completed using multivariate imputation by chained equations. We estimated the probability of receiving surgery versus another primary treatment using multivariable binomial logistic regression models. Univariable and multivariable Cox proportional hazards regression models were used for survival analysis. Results Females were older at diagnosis and had less comorbidities than men. There was no difference with respect to treatment decisions between men and women. The probability of receiving a primary treatment other than surgery was nearly twice as high in patients with the highest comorbidity index, CCI 2+, compared with patients without comorbidities. This effect was significantly stronger in women than in men (p-interaction = 0.010). Survival decreased with higher CCI, tumor stage and age in all CRC patients. Sex had no impact on survival. Conclusion The probability of receiving any primary treatment and survival were independent of sex. However, female CRC patients with the highest CCI appeared more likely to receive other therapy than surgery compared to their male counterparts.

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Routine use of immunosuppressants is associated with mortality in hospitalised patients with COVID-19

Therapeutic Advances in Drug Safety ◽

10.1177/2042098620985690 ◽

2021 ◽

Vol 12 ◽

pp. 204209862098569

Author(s):

Phyo K. Myint ◽

Ben Carter ◽

Fenella Barlow-Pay ◽

Roxanna Short ◽

Alice G. Einarsson ◽

...

Keyword(s):

Medical Attention ◽

Close Monitoring ◽

Plain Language ◽

Discharge Data ◽

Specific Patient ◽

Risk Of Death ◽

Hospitalised Patients ◽

Increased Risk ◽

The Uk ◽

The Impact

Background: Whilst there is literature on the impact of SARS viruses in the severely immunosuppressed, less is known about the link between routine immunosuppressant use and outcome in COVID-19. Consequently, guidelines on their use vary depending on specific patient populations. Methods: The study population was drawn from the COPE Study (COVID-19 in Older People), a multicentre observational cohort study, across the UK and Italy. Data were collected between 27 February and 28 April 2020 by trained data-collectors and included all unselected consecutive admissions with COVID-19. Load (name/number of medications) and dosage of immunosuppressant were collected along with other covariate data. Primary outcome was time-to-mortality from the date of admission (or) date of diagnosis, if diagnosis was five or more days after admission. Secondary outcomes were Day-14 mortality and time-to-discharge. Data were analysed with mixed-effects, Cox proportional hazards and logistic regression models using non-users of immunosuppressants as the reference group. Results: In total 1184 patients were eligible for inclusion. The median (IQR) age was 74 (62–83), 676 (57%) were male, and 299 (25.3%) died in hospital (total person follow-up 15,540 days). Most patients exhibited at least one comorbidity, and 113 (~10%) were on immunosuppressants. Any immunosuppressant use was associated with increased mortality: aHR 1.87, 95% CI: 1.30, 2.69 (time to mortality) and aOR 1.71, 95% CI: 1.01–2.88 (14-day mortality). There also appeared to be a dose–response relationship. Conclusion: Despite possible indication bias, until further evidence emerges we recommend adhering to public health measures, a low threshold to seek medical advice and close monitoring of symptoms in those who take immunosuppressants routinely regardless of their indication. However, it should be noted that the inability to control for the underlying condition requiring immunosuppressants is a major limitation, and hence caution should be exercised in interpretation of the results. Plain Language Summary Regular Use of Immune Suppressing Drugs is Associated with Increased Risk of Death in Hospitalised Patients with COVID-19 Background: We do not have much information on how the COVID-19 virus affects patients who use immunosuppressants, drugs which inhibit or reduce the activity of the immune system. There are various conflicting views on whether immune-suppressing drugs are beneficial or detrimental in patients with the disease. Methods: This study collected data from 10 hospitals in the UK and one in Italy between February and April 2020 in order to identify any association between the regular use of immunosuppressant medicines and survival in patients who were admitted to hospital with COVID-19. Results: 1184 patients were included in the study, and 10% of them were using immunosuppressants. Any immunosuppressant use was associated with increased risk of death, and the risk appeared to increase if the dose of the medicine was higher. Conclusion: We therefore recommend that patients who take immunosuppressant medicines routinely should carefully adhere to social distancing measures, and seek medical attention early during the COVID-19 pandemic.

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A Motion of No Confidence: Leadership and Rebel Fragmentation

Journal of Global Security Studies ◽

10.1093/jogss/ogz060 ◽

2020 ◽

Vol 5 (4) ◽

pp. 598-616 ◽

Cited By ~ 3

Author(s):

Austin C Doctor

Keyword(s):

Civil War ◽

Proportional Hazards ◽

Original Data ◽

Cox Proportional Hazards ◽

Stage I ◽

Logistic Regression Models ◽

Structure And Agency ◽

Rebel Groups ◽

Cox Proportional Hazards Models ◽

War Experiences

Abstract Why do rebel organizations splinter into competing factions during civil war? To explain this outcome, I leverage variation in rebel leadership. I argue that rebel leaders draw on their pre-war experiences—i.e., their military and political experiences—to manage their organizations during conflict. These experiences bear unique patterns of rebel management and, thus, corresponding risks of fragmentation. Empirical evidence comes from a two-stage research design and original data featuring over 200 rebel leaders from 1989 to 2014. In the first stage, I estimate the probability of group fragmentation with a series of logistic regression models. In the second stage, I use Cox proportional-hazards models to estimate leadership effects on the rate of group fragmentation. Results indicate that variation in rebel leadership corresponds with unique risks of fragmentation. In particular, the results suggest that leaders with real military experience are best equipped to maintain group cohesion. This study offers insight into the processes by which rebel groups splinter into armed factions. In addition, it makes an important contribution to the broader discussion on the roles of structure and agency in shaping the dynamics of civil war.

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The Longitudinal Association of Vision Impairment with Transitions to Cognitive Impairment and Dementia: Findings from The Aging, Demographics and Memory Study

The Journals of Gerontology Series A ◽

10.1093/gerona/glab157 ◽

2021 ◽

Author(s):

Joshua R Ehrlich ◽

Bonnielin K Swenor ◽

Yunshu Zhou ◽

Kenneth M Langa

Keyword(s):

Visual Acuity ◽

Logistic Regression ◽

Cognitive Impairment ◽

Proportional Hazards ◽

Population Based ◽

Cox Proportional Hazards ◽

Vision Impairment ◽

Logistic Regression Models ◽

Cox Proportional Hazards Models ◽

Longitudinal Association

Abstract Background Vision impairment (VI) is associated with incident cognitive decline and dementia. However, it is not known whether VI is associated only with the transition to cognitive impairment, or whether it is also associated with later transitions to dementia. Methods We used data from the population-based Aging, Demographics and Memory Study (ADAMS) to investigate the association of visual acuity impairment (VI; defined as binocular presenting visual acuity <20/40) with transitions from cognitively normal (CN) to cognitive impairment no dementia (CIND) and from CIND to dementia. Multivariable Cox proportional hazards models and logistic regression were used to model the association of VI with cognitive transitions, adjusted for covariates. Results There were 351 participants included in this study (weighted percentages: 45% male, 64% age 70-79 years) with a mean follow-up time of 4.1 years. In a multivariable model, the hazard of dementia was elevated among those with VI (HR=1.63, 95%CI=1.04-2.58). Participants with VI had a greater hazard of transitioning from CN to CIND (HR=1.86, 95%CI=1.09-3.18). However, among those with CIND and VI a similar percentage transitioned to dementia (48%) and remained CIND (52%); there was no significant association between VI and transitioning from CIND to dementia (HR=0.94, 95%CI=0.56-1.55). Using logistic regression models, the same associations between VI and cognitive transitions were identified. Conclusions Poor vision is associated with the development of CIND. The association of VI and dementia appears to be due to the higher risk of dementia among individuals with CIND. Findings may inform the design of future interventional studies.

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Overall survival (OS) and metastasis-free survival (MFS) by depth of prostate-specific antigen (PSA) decline in the phase III PROSPER trial of men with nonmetastatic castration-resistant prostate cancer (nmCRPC) treated with enzalutamide (ENZA).

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.6_suppl.94 ◽

2021 ◽

Vol 39 (6_suppl) ◽

pp. 94-94

Author(s):

Maha H. A. Hussain ◽

Cora N. Sternberg ◽

Eleni Efstathiou ◽

Karim Fizazi ◽

Qi Shen ◽

...

Keyword(s):

Proportional Hazards ◽

Reference Group ◽

Specific Antigen ◽

Cox Proportional Hazards ◽

Phase Iii ◽

Castration Resistant Prostate Cancer ◽

Analysis Model ◽

Increased Risk ◽

Psa Nadir ◽

Post Hoc

94 Background: The PROSPER trial demonstrated prolonged MFS and OS for men with nmCRPC and rapidly rising PSA treated with ENZA vs placebo, both in combination with androgen deprivation therapy (ADT). The final survival analysis of PROSPER (Sternberg et al. NEJM 2020) recently reported a median OS of 67.0 months (95% CI, 64.0 to not reached) with ENZA and 56.3 months (95% CI, 54.4 to 63.0) with placebo (hazard ratio [HR] for death, 0.73; 95% CI, 0.61 to 0.89; P = .001). Post hoc analyses of PROSPER evaluating PSA dynamics have demonstrated longer MFS with greater PSA decline (Hussain et al. ESMO Sept 19-21, 2020. Poster 685P) and increased risk of metastases in patients with even modest PSA progression vs those without (Saad et al. Eur Urol 2020). Here we further explored the relationship between PSA dynamics and outcomes in PROSPER using uniquely defined PSA subgroups of decline. Methods: Eligible men in PROSPER had nmCRPC, a PSA level ≥ 2 ng/mL at baseline, and a PSA doubling time ≤ 10 months. Men continued ADT, were randomized 2:1 to ENZA 160 mg once daily vs placebo, and had PSA evaluation at week 17 and every 16 weeks thereafter. This post hoc analysis evaluated OS and MFS for 4 mutually exclusive subgroups defined by PSA nadir using men with PSA reduction < 50% as the reference group. The HR is based on an unstratified Cox proportional hazards analysis model. Results: 1401 men were enrolled in PROSPER; 933 were treated with ENZA and PSA data were available for 905. Measured at nadir, 38% of these men achieved PSA reduction ≥ 90% (actual nadir < 0.2 ng/mL), and another 27% achieved PSA reduction ≥ 90% (actual nadir ≥ 0.2 ng/mL). Among men in the placebo arm of PROSPER only 3/457 reported PSA reduction ≥ 90%. Median OS and MFS increased with increasing depth of PSA decline (Table). Conclusions: In men with nmCRPC and rapidly rising PSA treated with ADT plus ENZA, there was a close relationship between the degree of PSA decline and survival outcomes. Defining PSA by both percent decline and actual decline below 0.2 ng/mL revealed a previously under-appreciated relationship between these PSA metrics and highlights the importance of PSA nadir as an intermediate biomarker in nmCRPC. Clinical trial information: NCT02003924. [Table: see text]

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Abstract 14093: High-Sensitivity C-reactive Protein Modifies the Effect of Lipoprotein (a) on Cardiovascular Risk: The Multi-Ethnic Study of Atherosclerosis (MESA)

Circulation ◽

10.1161/circ.142.suppl_3.14093 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Wei Zhang ◽

Jaime L Speiser ◽

Miguel Cainzos Achirica ◽

Khurram Nasir ◽

Michael Tsai ◽

...

Keyword(s):

Proportional Hazards ◽

Reference Group ◽

High Sensitivity ◽

Chinese Americans ◽

Cox Proportional Hazards ◽

Atherosclerotic Cardiovascular Disease ◽

C Reactive Protein ◽

Lipoprotein A ◽

Reactive Protein ◽

Ascvd Risk

Introduction: Lipoprotein (a) (Lp(a)) and inflammation, as represented by elevated high-sensitivity C-reactive protein (hsCRP) concentration, are both considered as risk-enhancers in the 2018 AHA/ACC Cholesterol guidelines. However, little is known as to whether the association of Lp(a) with atherosclerotic cardiovascular disease (ASCVD) risk is modified by inflammation. Objective: We assessed whether hsCRP modifies the association of Lp(a) with ASCVD risk. Methods: MESA participants with baseline hsCRP and Lp(a) levels were included. Incident ASCVD events were ascertained from baseline through 2017. Time to incident ASCVD was analyzed using Kaplan Meir curves. Cox proportional hazards models were used to assess the association between Lp(a), hsCRP, and time to ASCVD events adjusting for covariates. Results: The study included 4,654 participants with mean age of 62 and 52.5% females (1,702 Caucasians, 557 Chinese Americans, 1,336 African Americans and 1,059 Hispanics). With a mean 13.6-year follow-up, 676 ASCVD events occurred among 4,609 participants (Figure 1). In participants with hsCRP <2mg/L, the association of Lp(a) (per 1 Log unit increase) and risk for ASCVD as represented by hazard ratio (HR) and 95%CI was 1.01 (0.79, 1.28). In subjects with hsCRP ≥2mg/L, the risk increased to 1.26 (1.01, 1.58). When compared to the reference group with Lp(a) <50mg/dL and hsCRP <2mg/L, the risk for ASCVD in participants with Lp(a) ≥50mg/dL and hsCRP <2mg/L was 1.13 (0.85, 1.50) and in those with Lp(a) <50mg/dL and hsCRP ≥2mg/L was 1.09 (0.92, 1.31). The risk increased significantly to 1.62 (1.26, 2.07) in participants with Lp(a) ≥50mg/dL and hsCRP ≥2mg/L. Conclusions: Lp(a)-related ASCVD risk is modified by hsCRP levels. The findings of this analysis suggest that Lp(a) may serve as a risk enhancing factor in individuals with hsCRP level ≥2mg/L. Future studies are needed to determine whether Lp(a) is associated with risk of ASCVD in the absence of subclinical inflammation.

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Abdominal Obesity in Comparison with General Obesity and Risk of Developing Rheumatoid Arthritis in Women

The Journal of Rheumatology ◽

10.3899/jrheum.200056 ◽

2020 ◽

pp. jrheum.200056

Author(s):

Nathalie E. Marchand ◽

Jeffrey A. Sparks ◽

Sara K. Tedeschi ◽

Susan Malspeis ◽

Karen H. Costenbader ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Abdominal Obesity ◽

Proportional Hazards ◽

Cox Proportional Hazards ◽

Health Study ◽

General Obesity ◽

Middle Aged ◽

Covariate Data ◽

Cox Proportional Hazards Models ◽

Younger Age

Objective Being overweight or obese increases rheumatoid arthritis (RA) risk among women, particularly among those diagnosed at a younger age. Abdominal obesity may contribute to systemic inflammation more than general obesity; thus, we investigated whether abdominal obesity, compared to general obesity, predicted RA risk in 2 prospective cohorts: the Nurses’ Health Study (NHS) and NHS II. Methods We followed 50,682 women (1986–2014) in NHS and 47,597 women (1993–2015) in NHS II, without RA at baseline. Waist circumference (WC), BMI, health outcomes, and covariate data were collected through biennial questionnaires. Incident RA cases and serologic status were identified by chart review. We examined the associations of WC and BMI with RA risk using time-varying Cox proportional hazards models. We repeated analyses restricted to age ≤ 55 years. Results During 28 years of follow-up, we identified 844 incident RA cases (527 NHS, 317 NHS II). Women with WC > 88 cm (35 in) had increased RA risk (HR 1.22, 95% CI 1.06–1.41). A similar association was observed for seropositive RA, which was stronger among young and middle-aged women. Further adjustment for BMI attenuated the association to null. In contrast, BMI was associated with RA (HRBMI ≥ 30 vs < 25 1.33, 95% CI 1.05–1.68) and seropositive RA, even after adjusting for WC, and, as in WC analyses, this association was stronger among young and middle-aged women. Conclusion Abdominal obesity was associated with increased RA risk, particularly for seropositive RA, among young and middle-aged women; however, it did not independently contribute to RA risk beyond general obesity.

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Physical activity types and atrial fibrillation risk in the middle-aged and elderly: The Rotterdam Study

European Journal of Preventive Cardiology ◽

10.1177/2047487318780031 ◽

2018 ◽

Vol 25 (12) ◽

pp. 1316-1323 ◽

Cited By ~ 7

Author(s):

Marijn Albrecht ◽

Chantal M Koolhaas ◽

Josje D Schoufour ◽

Frank JA van Rooij ◽

M Kavousi ◽

...

Keyword(s):

Physical Activity ◽

Atrial Fibrillation ◽

Proportional Hazards ◽

Population Based ◽

Cox Proportional Hazards ◽

Total Physical Activity ◽

Rotterdam Study ◽

Cox Proportional Hazards Models ◽

Activity Types ◽

Study Population

Background The association between physical activity and atrial fibrillation remains controversial. Physical activity has been associated with a higher and lower atrial fibrillation risk. These inconsistent results might be related to the type of physical activity. We aimed to investigate the association of total and types of physical activity, including walking, cycling, domestic work, gardening and sports, with atrial fibrillation. Design Prospective cohort study. Methods Our study was performed in the Rotterdam Study, a prospective population-based cohort. We included 7018 participants aged 55 years and older with information on physical activity between 1997–2001. Cox proportional hazards models were used to examine the association of physical activity with atrial fibrillation risk. Models were adjusted for biological and behavioural risk factors and the remaining physical activity types. Physical activity was categorised in tertiles and the low group was used as reference. Results During 16.8 years of follow-up (median: 12.3 years, interquartile range: 8.7–15.9 years), 800 atrial fibrillation events occurred (11.4% of the study population). We observed no association between total physical activity and atrial fibrillation risk in any model. After adjustment for confounders, the hazard ratio and 95% confidence interval for the high physical activity category compared to the low physical activity category was: 0.71 (0.80–1.14) for total physical activity. We did not observe a significant association between any of the physical activity types with atrial fibrillation risk. Conclusion Our results suggest that physical activity is not associated with higher or lower risk of atrial fibrillation in older adults. Neither total physical activity nor any of the included physical activity types was associated with atrial fibrillation risk.

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