Photosynthetic conversion of carbon dioxide from cement production to microalgae biomass.

Production of microalgae is a potential technology for capturing and recycling carbon dioxide from cement kiln emissions. In this study, a process of selecting a suitable strain that would effectively utilize carbon dioxide and generate biomass was investigated. A down-selection screening method was applied to 28 strains isolated from the area surrounding a commercial cement plant. In laboratory-scale (1 L) continuous-mode chemostats, observed productivity was > 0.9 g L-1 d-1 for most strains studied. Chlorella sorokiniana (strain SMC-14M) appeared to be the most tolerant to cement kiln gas emissions in situ, delivered under control of a pH-stat system, and was down-selected to further investigate growth and biomass production at large-scale (1000 L) cultivation. Results demonstrated little variability in lipid, crude protein, and carbohydrate composition throughout growth between kiln-gas grown algal biomass and biomass produced with laboratory grade CO2. The growth rate at which the maximum quantity of CO2 from the emissions is recycled also produced the maximum amount of the targeted biomass components to increase commercial value of the biomass. An accumulation of some heavy metals throughout its growth demonstrates the necessity to monitor the biomass cultivated with industrial flue gases and to carefully consider the potential applications for this biomass; despite its other attractive nutritional properties. KEY POINTS: • Studied high biomass producing algal strains grown on CO2 from cement flue gas. • Chlorella sorokiniana SMC-14M grew well at large scale, in situ on cement flue gas. • Demonstrated the resulting commercial potential of the cultured algal biomass.

An international survey of experiences and attitudes towards pacing using a heart rate monitor for people with myalgic encephalomyelitis/chronic fatigue syndrome.

BACKGROUND: Myalgic encephalomyelitis (ME) is a complex, multi-system neurological condition. The defining feature of ME is post-exertional malaise (PEM) with over 30 symptoms triggered by physical, cognitive, emotional and social activity. The cause of PEM is unclear but one area of research using cardio-pulmonary exercise tests show a reduced ventilatory anaerobic threshold (VAT) with repeated tests leading to PEM. Pacing with heart rate monitoring (HRM) provides feedback to maintain activity intensity below the VAT. There is only one piece of research investigating the use of HRM although a number of guidelines recommend it. OBJECTIVE: To identify the experiences and attitudes of people with ME towards HRM. METHODS: A 40 question online survey was devised and released on ME websites, Twitter and Facebook pages. People with ME read the information sheet and followed an online link to the survey. The survey was open for three weeks and all answers were anonymous. RESULTS: 488 people with ME completed the survey. Most participants were female, 35-50 years and with a reported illness of greater than 5 years. Over 100 types of HR monitor used. Over 30 benefits and over 30 negatives identified. HRM reduced severity of ME and severity and duration of PEM. CONCLUSION: Although there are limitations, HRM has many benefits including helping PwME to understand and manage their PEM and support them to increase their activities, including work. There is a need for more research and education of healthcare professionals in the safe use of HRM.

Perception of Breakfast Ingestion Enhances High-Intensity Cycling Performance.

PURPOSE: To examine the effect on short-duration, high-intensity cycling time-trial (TT) performance when a semisolid breakfast containing carbohydrate (CHO) or a taste- and texture-matched placebo is ingested 90 min preexercise compared with a water (WAT) control. METHODS: A total of 13 well-trained cyclists (mean [SD]: age = 25 [8] y, body mass = 71.1 [5.9] kg, height = 1.76 [0.04] m, maximum power output = 383 [46] W, and peak oxygen uptake = 4.42 [0.53] L·min-1) performed 3 experimental trials examining breakfast ingestion 90 min before a 10-min steady-state cycle (60% maximum power output) and an ∼20-min TT (to complete a workload target of 376 [36] kJ). Subjects consumed either WAT, a semisolid CHO breakfast (2 g carbohydrate CHO·kg-1 body mass), or a taste- and texture-matched placebo (PLA). Blood lactate and glucose concentrations were measured periodically throughout the rest and exercise periods. RESULTS: The TT was completed more quickly in CHO (1120 [69] s; P = .006) and PLA (1112 [50] s; P = .030) compared with WAT (1146 [74] s). Ingestion of CHO caused an increase in blood glucose concentration throughout the rest period in CHO (peak at 30-min rest = 7.37 [1.10] mmol·L-1; P < .0001) before dropping below baseline levels after the steady-state cycling. CONCLUSION: A short-duration cycling TT was completed more quickly when subjects perceived that they had consumed breakfast (PLA or CHO) 90 min prior to the start of the exercise. The improvement in performance is likely attributable to a psychological rather than physiological effect.

Out-of-Hospital Pediatric Patient Safety Events: Results of the CSI Chart Review.

OBJECTIVE: Studies of adult hospital patients have identified medical errors as a significant cause of morbidity and mortality. Little is known about the frequency and nature of pediatric patient safety events in the out-of-hospital setting. We sought to quantify pediatric patient safety events in EMS and identify patient, call, and care characteristics associated with potentially severe events. METHODS: As part of the Children's Safety Initiative -EMS, expert panels independently reviewed charts of pediatric critical ambulance transports in a metropolitan area over a three-year period. Regression models were used to identify factors associated with increased risk of potentially severe safety events. Patient safety events were categorized as: Unintended injury; Near miss; Suboptimal action; Error; or Management complication ("UNSEMs") and their severity and potential preventability were assessed. RESULTS: Overall, 265 of 378 (70.1%) unique charts contained at least one UNSEM, including 146 (32.8%) errors and 199 (44.7%) suboptimal actions. Sixty-one UNSEMs were categorized as potentially severe (23.3% of UNSEMs) and nearly half (45.3%) were rated entirely preventable. Two factors were associated with heightened risk for a severe UNSEM: (1) age 29 days to 11 months (OR 3.3, 95% CI 1.25-8.68); (2) cases requiring resuscitation (OR 3.1, 95% CI 1.16-8.28). Severe UNSEMs were disproportionately higher among cardiopulmonary arrests (8.5% of cases, 34.4% of severe UNSEMs). CONCLUSIONS: During high-risk out-of-hospital care of pediatric patients, safety events are common, potentially severe, and largely preventable. Infants and those requiring resuscitation are important areas of focus to reduce out-of-hospital pediatric patient safety events.

Patient safety events in out-of-hospital paediatric airway management: a medical record review by the CSI-EMS.

OBJECTIVE: To describe the frequency and characterise the nature of patient safety events in paediatric out-of-hospital airway management. METHODS: We conducted a retrospective cross-sectional medical record review of all 'lights and sirens' emergency medicine services transports from 2008 to 2011 in patients <18 years of age in the Portland Oregon metropolitan area. A chart review tool (see online supplementary appendix) was adapted from landmark patient safety studies and revised after pilot testing. Expert panels of physicians and paramedics performed blinded reviews of each chart, identified safety events and described their nature. The primary outcomes were presence and severity of patient safety events related to airway management including oxygen administration, bag-valve-mask ventilation (BVM), airway adjuncts and endotracheal intubation (ETI).DC1SM110.1136/bmjopen-2016-012259.supp1supplementary appendix RESULTS: From the 11 328 paediatric transports during the study period, there were 497 'lights and sirens' (code 3) transports (4.4%). 7 transports were excluded due to missing data. Of the 490 transports included in the analysis, 329 had a total of 338 airway management procedures (some had more than 1 procedure): 61.6% were treated with oxygen, 15.3% with BVM, 8.6% with ETI and 2% with airway adjuncts. The frequency of errors was: 21% (71/338) related to oxygen use, 9.8% (33/338) related to BVM, 9.5% (32/338) related to intubation and 0.9% (3/338) related to airway adjunct use. 58% of intubations required 3 or more attempts or failed altogether. Cardiac arrest was associated with higher odds of a severe error. CONCLUSIONS: Errors in paediatric out-of-hospital airway management are common, especially in the context of intubations and during cardiac arrest.

Pediatric Airway Management and Prehospital Patient Safety: Results of a National Delphi Survey by the Children's Safety Initiative-Emergency Medical Services for Children.

OBJECTIVE: The objective of this study was to determine what aspects of prehospital pediatric airway management may contribute to patient safety events. METHODS: We conducted a 3-phase Delphi survey in prehospital professionals across the United States to identify potential contributors to patient safety events. Respondents ranked how likely factors were to contribute on a 9-point Likert-type scale and were allowed to elaborate through open-ended questions. Analysis was conducted using a mixed-methods approach, including Likert-type responses and open-ended questions which were analyzed for specific themes. RESULTS: All 3 phases of the survey were completed by 492 participants; 50.8% of respondents were paramedics, 22% were emergency medical technician-basics/first responders, and 11.4% were physicians. Seventy-five percent identified lack of experience with advanced airway management, and 44% identified medical decision making regarding airway interventions as highly likely to lead to safety events. Within the domain of technical skills, advanced airway management was ranked in the top 3 contributors to safety events by 71% of participants, and bag-mask ventilation by 18%. Qualitative analysis of questions within the domains of equipment and technical skills identified endotracheal intubation as the top contributor to safety events, with bag-mask ventilation second. In the domains of assessment and decision making, respiratory assessment and knowing when to perform an advanced airway were ranked most highly. CONCLUSIONS: This national Delphi survey identified lack of experience with pediatric airway management and challenges in decision making in advanced airway management as high risk for safety events, with endotracheal intubation as the most likely of these.

Patient Safety Perceptions in Pediatric Out-of-Hospital Emergency Care: Children's Safety Initiative.

OBJECTIVE: To characterize emergency medical service (EMS) providers' perceptions of the factors that contribute to safety events and errors in the out-of-hospital emergency care of children. STUDY DESIGN: We used a Delphi process to achieve consensus in a national sample of 753 emergency medicine physicians and EMS professionals. Convergence and stability were achieved in 3 rounds, and findings were reviewed and interpreted by a national expert panel. RESULTS: Forty-four (88%) states were represented, and 66% of participants were retained through all 3 rounds. From an initial set of 150 potential contributing factors derived from focus groups and literature, participants achieved consensus on the following leading contributors: airway management, heightened anxiety caring for children, lack of pediatric skill proficiency, lack of experience with pediatric equipment, and family members leading to delays or interference with care. Somewhat unexpectedly, medications and communication were low-ranking concerns. After thematic analysis, the overarching domains were ranked by their relative importance: (1) clinical assessment; (2) training; (3) clinical decision-making; (4) equipment; (5) medications; (6) scene characteristics; and (7) EMS cultural norms. CONCLUSIONS: These findings raise considerations for quality improvement and suggest important roles for pediatricians and pediatric emergency physicians in training, medical oversight, and policy development.

Primary care clinician adherence to guidelines for the management of chronic musculoskeletal pain: results from the study of the effectiveness of a collaborative approach to pain.

OBJECTIVE: We assessed primary care clinician-provided guideline-concordant care as documented in patients' medical records, predictors of documented guideline-concordant care, and its association with pain-related functioning. Patients were participants in a randomized trial of collaborative care for chronic musculoskeletal pain. The intervention featured patient and primary care clinician education, symptom monitoring and feedback to clinicians by the intervention team. METHODS: To assess concordance with the evidence-based treatment guidelines upon which our intervention was based, we developed an 8-item chart review tool, the Pain Process Checklist (PPC). We then reviewed electronic medical records for 365 veteran patients treated by 42 primary care clinicians over 12 months. Intervention status, demographic, and clinical variables were tested as predictors of PPC scores using generalized estimating equations (GEE). GEE was also used to test whether PPC scores predicted treatment response (≥30% decrease in Roland-Morris Disability Questionnaire score). RESULTS: Rates of documented guideline-concordant care varied widely among PPC items, from 94% of patients having pain addressed to 17% of patients on opioids having side effects addressed. Intervention status was unrelated to item scores, and PPC-7 totals did not differ significantly between intervention and treatment-as-usual patients (61.2%, standard error [SE] = 3.3% vs 55.2%, SE = 2.6%, P = 0.15). In a multivariate model, higher PPC-7 scores were associated with receiving a prescription for opioids (odds ratio [OR] = 1.07, P = 0.007) and lower PPC-7 scores with patient age (10-year difference OR = 0.97, P = 0.004). Finally, intervention patients who received quantitative pain and depression assessments were less likely to respond to treatment (assessed vs not: 18% vs 33%, P = 0.008, and 13% vs 28%, P = 0.001, respectively). CONCLUSIONS: As measured by medical record review, additional training and clinician feedback did not increase provision of documented guideline-concordant pain care, and adherence to guidelines by primary care clinicians did not improve clinical outcomes for patients with chronic musculoskeletal pain.

Integration of microalgae cultivation with industrial waste remediation for biofuel and bioenergy production: opportunities and limitations.

There is currently a renewed interest in developing microalgae as a source of renewable energy and fuel. Microalgae hold great potential as a source of biomass for the production of energy and fungible liquid transportation fuels. However, the technologies required for large-scale cultivation, processing, and conversion of microalgal biomass to energy products are underdeveloped. Microalgae offer several advantages over traditional 'first-generation' biofuels crops like corn: these include superior biomass productivity, the ability to grow on poor-quality land unsuitable for agriculture, and the potential for sustainable growth by extracting macro- and micronutrients from wastewater and industrial flue-stack emissions. Integrating microalgal cultivation with municipal wastewater treatment and industrial CO(2) emissions from coal-fired power plants is a potential strategy to produce large quantities of biomass, and represents an opportunity to develop, test, and optimize the necessary technologies to make microalgal biofuels more cost-effective and efficient. However, many constraints on the eventual deployment of this technology must be taken into consideration and mitigating strategies developed before large scale microalgal cultivation can become a reality. As a strategy for CO(2) biomitigation from industrial point source emitters, microalgal cultivation can be limited by the availability of land, light, and other nutrients like N and P. Effective removal of N and P from municipal wastewater is limited by the processing capacity of available microalgal cultivation systems. Strategies to mitigate against the constraints are discussed.

Alcohol consumption and health status in very old veterans.

Previous research has linked drinking with health, but has yet to address alcohol consumption and the relationship between drinking and health among very old veterans. To help fill this gap, the authors present a cross-sectional self-report study on 1105 veterans age 90 and older who completed the national Veteran's Affairs (VA) Survey of the Health Experiences of Patients (SHEP) for fiscal year (FY) 2005. Alcohol consumption was measured using Alcohol Use Disorders Identification Test scores (AUDIT-C). Health status was measured using the Veterans Rand Health Survey: VR-12. Among men (n = 1063), 60% were abstainers. No significant differences in mental health component (MCS; F(3,1040) = 1.80, P = .15) or physical health component (PCS; F(3,1040) = 1.48, P = .22) scores were detected across consumption categories. Among women (n = 42), 47% were abstainers. These results suggest many very old veterans abstain from alcohol and, among men, the associations between health status and drinking observed in younger groups may not be present in very old age.

Suicide risk assessment and content of VA health care contacts before suicide completion by veterans in Oregon.

OBJECTIVE: This study described health care contacts at a Department of Veterans Affairs (VA) medical center in Oregon in the year before death of veterans who completed suicide. METHODS: Oregon Violent Death Reporting System (OVDRS) data and VA administrative data were linked to identify the 112 veterans who completed suicide in Oregon between 2000 and 2005 and who had contact with a single VA medical center in the year before death. Medical records were reviewed to collect data on clinician assessment of suicide risk and reasons for the last contact. RESULTS: In the year before death, 54 veterans (48%) had one or more mental health contacts and 71 (63%) had one or more primary care contacts. The mean age was 57; common diagnoses included mood disorders (38%) and cardiovascular disease (38%). The median number of days between the last contact and date of death was 42 (range=0-358). Thirty-six last contacts (32%) were patient initiated for new or exacerbated medical concerns, and 76 (68%) were follow-ups for ongoing problems. Clinicians noted that 41 patients (37%) were experiencing emotional distress at the last contact. Thirteen of the 18 patients (72%) who were assessed for suicidal ideation at their last contact denied such thoughts. CONCLUSIONS: During their last contact, most veterans were seen for routine medical care and few endorsed thoughts of suicide. Results underscore challenges that clinicians face in identifying and caring for veterans at risk of suicide in health care settings. Additional research is indicated to identify better ways to facilitate communication of suicidal thoughts when they are present.

VA healthcare costs of a collaborative intervention for chronic pain in primary care.

BACKGROUND: Chronic pain is costly to individuals and the healthcare system, and is often undertreated. Collaborative care models show promise for improving treatment of patients with chronic pain. The objectives of this article are to report the incremental benefit and incremental health services costs of a collaborative intervention for chronic pain from a veterans affairs (VA) healthcare perspective. METHODS: Data on VA treatment costs incurred by participants were obtained from the VA's Decision Support System for all utilization except certain intervention activities which were tracked in a separate database. Outcome data were from a cluster-randomized trial of a collaborative intervention for chronic pain among 401 primary care patients at a VA medical center. Intervention group participants received assessments and care management; stepped-care components were offered to patients requiring more specialized care. The main outcome measure was pain disability-free days (PDFDs), calculated from Roland-Morris Disability Questionnaire scores. RESULTS: Participants in the intervention group experienced an average of 16 additional PDFDs over the 12-month follow-up window as compared with usual care participants; this came at an adjusted incremental cost of $364 per PDFD for a typical participant. Important predictors of costs were baseline medical comorbidities, depression severity, and prior year's treatment costs. CONCLUSIONS: This collaborative intervention resulted in more pain disability-free days and was more expensive than usual care. Further research is necessary to identify if the intervention is more cost-effective for some patient subgroups and to learn whether pain improvements and higher costs persist after the intervention has ended.

Associations between race and ethnicity and treatment for chronic pain in the VA.

UNLABELLED: The purpose of this study was to identify racial and ethnic differences in patient-reported rates of treatment for chronic pain and ratings of pain-treatment effectiveness among veterans treated in Veterans Affairs (VA) facilities. This was a cross-sectional analysis of data from 255,522 veterans who participated in the VA Survey of the Healthcare Experiences of Patients (SHEP) in Fiscal Year 2005. Measures included demographics, the Veterans Rand Health Survey-12, a single item inquiring if the patient received treatment for chronic pain in the VA within the prior 12 months, and a single item asking the patient to rate the effectiveness of chronic pain care. In a logistic model adjusting for demographics, pain interference, and mental health status, male and female veterans who were Hispanic (OR 1.39 [95%CI 1.26-1.53] and OR 1.57 [1.02-2.43], respectively) or non Hispanic black (OR 1.43 [1.33-1.54] and OR 1.35 [1.02-1.78], respectively) were more likely to report receiving treatment for chronic pain in the prior 12 months compared to non Hispanic white veterans. Among veterans who reported receiving treatment for chronic pain, non Hispanic black men were less likely to rate pain-treatment effectiveness as very good or excellent, compared to non Hispanic white men (OR .809 [.720-.910]). PERSPECTIVE: In our study, Hispanic and non Hispanic black veterans reported receiving chronic pain treatment more frequently than white veterans. Among veterans reporting pain treatment, non Hispanic black men were somewhat less likely to report receiving highly effective treatment than white men. Further research is needed to understand the reasons for these differences and their potential clinical implications.

Associations between race and ethnicity and receipt of advice about alcohol use in the Department of Veterans Affairs.

OBJECTIVE: This study sought to identify racial and ethnic differences in rates of alcohol-related advice given to veterans treated in Veterans Affairs (VA) facilities. METHODS: This was a cross-sectional analysis of data from the VA Survey of the Healthcare Experiences of Patients (SHEP). Participants were 255,522 veterans treated in VA ambulatory clinics in fiscal year 2005. SHEP measures included alcohol consumption questions from the Alcohol Use Disorders Identification Test and an item inquiring whether a VA clinician had given advice about drinking. Logistic regression was used to examine relationships between race and ethnicity categories and receipt of alcohol-related advice. Covariate measures included demographic characteristics and physical and mental component summary scores from the Veterans RAND Health Survey (VR-12). RESULTS: Among veterans who consumed any alcohol, compared with veterans from the other racial or ethnic groups, Asian, Native Hawaiian, or Pacific Islander veterans were less likely to be in the medium and highest alcohol consumption categories and non-Hispanic white veterans were less likely to be in the highest alcohol consumption category (p<.001). In a model adjusting for demographic characteristics, physical and mental health status, and alcohol consumption category, among veterans who consumed any alcohol, those who were non-Hispanic black (odds ratio [OR]=1.65, 95% confidence interval [CI]=1.47-1.84), Hispanic (OR=1.56, CI=1.35-1.80), or non-Hispanic American Indian or Alaska Native (OR=1.56, CI=1.06-2.29) were more likely to report receiving alcohol-related advice, compared with non-Hispanic white veterans. CONCLUSIONS: The results suggest that veterans from certain minority groups are more likely than white veterans to report receiving alcohol-related advice in the VA, after the model is adjusted for demographic characteristics, health status, and alcohol consumption. Further research is needed to understand the underlying reasons for observed differences in receipt of alcohol-related advice and the potential clinical implications.

Collaborative care for chronic pain in primary care: a cluster randomized trial.

CONTEXT: Chronic pain is common in primary care patients and is associated with distress, disability, and increased health care use. OBJECTIVE: To assess whether a collaborative intervention can improve chronic pain-related outcomes, including comorbid depression severity, in a Department of Veterans Affairs primary care setting. DESIGN, SETTING, AND PARTICIPANTS: Cluster randomized controlled trial of a collaborative care assistance with pain treatment intervention vs treatment as usual at 5 primary care clinics of 1 Department of Veterans Affairs Medical Center. Forty-two primary care clinicians were randomized to the assistance with pain treatment intervention group or the treatment as usual group. The 401 patients had musculoskeletal pain diagnoses, moderate or greater pain intensity, and disability lasting 12 weeks or longer and were assigned to the same treatment groups as their clinicians. Recruitment occurred from January 2006 to January 2007 and follow-up concluded in January 2008. INTERVENTION: Assistance with pain treatment included a 2-session clinician education program, patient assessment, education and activation, symptom monitoring, feedback and recommendations to clinicians, and facilitation of specialty care. MAIN OUTCOME MEASURES: Changes over 12 months in pain-related disability (Roland-Morris Disability Questionnaire, range of 0-24), pain intensity (Chronic Pain Grade [CPG] Pain Intensity subscale, range of 0-100), and depression (Patient Health Questionnaire 9 [PHQ-9], range of 0-27), measured as beta coefficients (difference in slopes in points per month). RESULTS: Intervention patients had a mean (SD) of 10.6 (4.5) contacts with the assistance with pain treatment team. Compared with the patients receiving treatment as usual, intervention patients showed greater improvements in pain-related disability (Roland-Morris Disability Questionnaire beta, -0.101 [95% confidence interval {CI}, -0.163 to -0.040]; P = .004 and CPG Pain Intensity subscale beta, -0.270 [95% CI, -0.480 to -0.061]; P = .01). Among patients with baseline depression (PHQ-9 score > or = 10), there was greater improvement in depression severity in patients receiving the intervention compared with patients receiving treatment as usual (PHQ-9 beta, -0.177 [95% CI, -0.295 to -0.060]; P = .003). The differences in scores between baseline and 12 months for the assistance with pain treatment intervention group and the treatment as usual group, respectively, were -1.4 vs -0.2 for the Roland-Morris Disability Questionnaire, -4.7 vs -0.6 for the CPG Pain Intensity subscale, and -3.7 vs -1.2 for PHQ-9. CONCLUSION: The assistance with pain treatment collaborative intervention resulted in modest but statistically significant improvement in a variety of outcome measures. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00129480.

Maternal smoking and the risk for clubfoot in infants.

BACKGROUND: Clubfoot is one of the most common major birth defects, with a prevalence of approximately 1 per 1,000 live births. The etiology of clubfoot is complex and not well understood, and yet, few epidemiologic studies of risk factors have been conducted. Maternal smoking has been suggested as a possible risk factor. The purpose of this population-based, case-control study was to examine the association between maternal smoking and clubfoot. METHODS: Data from the North Carolina Birth Defects Monitoring Program matched to North Carolina birth certificates and health services data were used in the analysis of 443 cases of clubfoot and 4,492 randomly sampled controls for the years 1999-2003. Smoking data were ascertained from the birth certificates, and the reliability of the data was assessed by comparing them with reported smoking from the North Carolina Pregnancy Risk Assessment Monitoring System. Multiple logistic regression was used to calculate crude and adjusted ORs and 95% CIs for smoking and clubfoot. RESULTS: The crude OR for maternal smoking during pregnancy and clubfoot was 1.49 (95% CI: 1.15, 1.92). Controlling for maternal age, race/ethnicity, infant's sex, and timing of prenatal care initiation did not appreciably change the results (adjusted OR 1.40; 95% CI: 1.07, 1.83). CONCLUSIONS: This study is consistent with the hypothesis that smoking during pregnancy is associated with a slightly increased risk of an infant being born with clubfoot. Further research is needed to confirm this association, and to identify potential genetic factors that may modify the magnitude of the risk.