Pre-hospital tranexamic acid administration in patients with a severe hemorrhage: an evaluation after the implementation of tranexamic acid administration in the Dutch pre-hospital protocol.

PURPOSE: To evaluate the pre-hospital administration of tranexamic acid in ambulance-treated trauma patients with a severe hemorrhage after the implementation of tranexamic acid administration in the Dutch pre-hospital protocol. METHODS: All patients with a severe hemorrhage who were treated and conveyed by EMS professionals between January 2015, and December 2017, to any trauma-receiving emergency department in the eight participating trauma regions in the Netherlands, were included. A severe hemorrhage was defined as extracranial injury with > 20% body volume blood loss, an extremity amputation above the wrist or ankle, or a grade ≥ 4 visceral organ injury. The main outcome was to determine the proportion of patients with a severe hemorrhage who received pre-hospital treatment with tranexamic acid. A Generalized Linear Model (GLM) was performed to investigate the relationship between pre-hospital tranexamic acid treatment and 24 h mortality. RESULTS: A total of 477 patients had a severe hemorrhage, of whom 124 patients (26.0%) received tranexamic acid before arriving at the hospital. More than half (58.4%) of the untreated patients were suspected of a severe hemorrhage by EMS professionals. Patients treated with tranexamic acid had a significantly lower risk on 24 h mortality than untreated patients (OR 0.43 [95% CI 0.19-0.97]). CONCLUSION: Approximately a quarter of the patients with a severe hemorrhage received tranexamic acid before arriving at the hospital, while a severe hemorrhage was suspected in more than half of the non-treated patients. Severely hemorrhaging patients treated with tranexamic acid before arrival at the hospital had a lower risk to die within 24 h after injury.

Accuracy of Prehospital Triage of Adult Patients With Traumatic Injuries Following Implementation of a Trauma Triage Intervention.

Importance: Adequate prehospital triage is pivotal to enable optimal care in inclusive trauma systems and reduce avoidable mortality, lifelong disabilities, and costs. A model has been developed to improve the prehospital allocation of patients with traumatic injuries and was incorporated in an application (app) to be implemented in prehospital practice. Objective: To evaluate the association between the implementation of a trauma triage (TT) intervention with an app and prehospital mistriage among adult trauma patients. Design, Setting, and Participants: This population-based, prospective quality improvement study was conducted in 3 of the 11 Dutch trauma regions (27.3%), with full coverage of the corresponding emergency medical services (EMS) regions participating in this study. Participants included adult patients (age ≥16 years) with traumatic injuries who were transported by ambulance between February 1, 2015, and October 31, 2019, from the scene of injury to any emergency department in the participating trauma regions. Data were analyzed between July 2020 and June 2021. Exposures: Implementation of the TT app and the awareness of need for adequate triage created by its implementation (ie, the TT intervention). Main Outcomes and Measures: The primary outcome was prehospital mistriage, evaluated in terms of undertriage and overtriage. Undertriage was defined as the proportion of patients with an Injury Severity Score (ISS) of 16 or greater who were initially transported to a lower-level trauma center (designated to treat patients who are mildly and moderately injured) and overtriage as the proportion of patients with an ISS of less than 16 who were initially transported to a higher-level trauma center (designated to treat patients who are severely injured). Results: A total of 80 738 patients were included (40 427 [50.1%] before and 40 311 [49.9%] after implementation of the intervention), with a median (IQR) age of 63.2 (40.0-79.7) years and 40 132 (49.7%) male patients. Undertriage decreased from 370 of 1163 patients (31.8%) to 267 of 995 patients (26.8%), while overtriage rates did not increase (8202 of 39 264 patients [20.9%] vs 8039 of 39 316 patients [20.4%]). The implementation of the intervention was associated with a statistically significantly reduced risk for undertriage (crude risk ratio [RR], 0.95; 95% CI, 0.92 to 0.99, P = .01; adjusted RR, 0.85; 95% CI, 0.76-0.95; P = .004), but the risk for overtriage was unchanged (crude RR, 1.00; 95% CI, 0.99-1.00; P = .13; adjusted RR, 1.01; 95% CI, 0.98-1.03; P = .49). Conclusions and Relevance: In this quality improvement study, implementation of the TT intervention was associated with improvements in rates of undertriage. Further research is needed to assess whether these findings are generalizable to other trauma systems.

Evaluating the influence of alcohol intoxication on the pre-hospital identification of severe head injury: a multi-center, cohort study.

OBJECTIVE: To determine the influence of intoxication on the pre-hospital recognition of severely head-injured patients by Emergency Medical Services (EMS) professionals and to investigate the relationship between suspected alcohol intoxication and severe head injury. METHODS: This multi-center, retrospective, cohort study included trauma patients, aged ≥ 16 years, transported by an ambulance of the Regional Ambulance Facility Utrecht to any emergency department in the participating trauma regions. RESULTS: Between January 1, 2015 and December 31, 2017, 19,206 patients were included, of whom 1167 (6.0%) were suspected to have a severe head injury in the field, and 623 (3.2%) were diagnosed with such an injury at the hospital. These injuries were less frequently recognized in patients with a GCS ≥ 13 than in patients with a GCS < 13 (25.0% vs. 76.2%). Patients suspected to be intoxicated had a higher chance to suffer from severe head injury (OR 1.42, 95%-CI 1.22-1.65) and were recognized slightly more often (45.3% vs. 40.2%). CONCLUSION: Severe head injuries are difficult to recognize in the field, especially in patients without a decreased GCS. Suspicion of alcohol intoxication did not seem to influence pre-hospital injury recognition, as it possibly makes a severe head injury harder to recognize and simultaneously raises caution for a severe injury.

The influence of inter-hospital transfers on mortality in severely injured patients.

PURPOSE: The importance of treating severely injured patients in higher-level trauma centers is undisputable. However, it is uncertain whether severely injured patients that were initially transported to a lower-level trauma center (i.e., undertriage) benefit from being transferred to a higher-level trauma center. METHODS: This observational study included all severely injured patients (i.e., Injury Severity Score ≥ 16) that were initially transported to a lower-level trauma center within eight ambulance regions. The exposure of interest was whether a patient was transferred to a higher-level trauma center. Primary outcomes were 24-h and 30-day mortality. Generalized linear models including inverse probability weights for several potential confounders were constructed to evaluate the association between transfer status and mortality. RESULTS: We included 165,404 trauma patients that were transported with high priority to a trauma center, of which 3932 patients were severely injured. 1065 (27.1%) patients were transported to a lower-level trauma center of which 322 (30.2%) were transferred to a higher-level trauma center. Transferring undertriaged patients to a higher-level trauma center was significantly associated with reduced 24-h (relative risk [RR] 0.26, 95%-CI 0.10-0.68) and 30-day mortality (RR 0.65, 0.46-0.92). Similar results were observed in patients with critical injuries (24-h: RR 0.35, 0.16-0.77; 30-day: RR 0.55, 0.37-0.80) and patients with traumatic brain injury (24-h: RR 0.31, 0.11-0.83; 30-day: RR 0.66, 0.46-0.96). CONCLUSIONS: A minority of the undertriaged patients are transferred to a higher-level trauma center. An inter-hospital transfer appears to be safe and may improve the survival of severely injured patients initially transported to a lower-level trauma center.

Evaluating pre-hospital triage and decision-making in patients who died within 30 days post-trauma: A multi-site, multi-center, cohort study.

INTRODUCTION: Evaluating pre-hospital triage and decision-making in patients who died post-trauma is crucial to decrease undertriage and improve future patients' chances of survival. A study that has adequately investigated this is currently lacking. The aim of this study was therefore to evaluate pre-hospital triage and decision-making in patients who died within 30 days post-trauma. MATERIALS AND METHODS: A multi-site, multi-center, cohort study was conducted. Trauma patients who were transported from the scene of injury to a trauma center by ambulance and died within 30 days post-trauma, were included. The main outcome was undertriage, defined as erroneously transporting a severely injured patient (Injury Severity Score ≥ 16) to a lower-level trauma center. RESULTS: Between January 2015 and December 2017, 2116 patients were included, of whom 765 (36.2%) were severely injured. A total of 103 of these patients (13.5%) were undertriaged. Undertriaged patients were often elderly with a severe head and/or thoracic injury as a result of a minor fall (< 2 m). A majority of the undertriaged patients were triaged without assistance of a specialized physician (100 [97.1%]), did not meet field triage criteria for level-I trauma care (81 [78.6%]), and could have been transported to the nearest level-I trauma center within 45 min (93 [90.3%]). CONCLUSION: Approximately 14% of the severely injured patients who died within 30 days were undertriaged and could have benefited from treatment at a level-I trauma center (i.e., specialized trauma care). Improvement of pre-hospital triage is needed to potentially increase future patients' chances of survival.

Impact of the SARS-CoV-2 pandemic on trauma care: a nationwide observational study.

PURPOSE: The SARS-CoV-2 pandemic severely disrupted society and the health care system. In addition to epidemiological changes, little is known about the pandemic's effects on the trauma care chain. Therefore, in addition to epidemiology and aetiology, this study aims to describe the impact of the SARS-CoV-2 pandemic on prehospital times, resource use and outcome. METHODS: A multicentre observational cohort study based on the Dutch Nationwide Trauma Registry was performed. Characteristics, resource usage, and outcomes of trauma patients treated at all trauma-receiving hospitals during the first (W1, March 12 through May 11) and second waves (W2, May 12 through September 23), as well as the interbellum period in between (INT, September 23 through December 31), were compared with those treated from the same periods in 2018 and 2019. RESULTS: The trauma caseload was reduced by 20% during the W1 period and 11% during the W2 period. The median length of stay was significantly shortened for hip fracture and major trauma patients (ISS ≥ 16). A 33% and 66% increase in the prevalence of minor self-harm-related injuries was recorded during the W1 and W2 periods, respectively, and a 36% increase in violence-related injuries was recorded during the INT. Mortality was significantly higher in the W1 (2.9% vs. 2.2%) and W2 (3.2% vs. 2.7%) periods. CONCLUSION: The imposed restrictions in response to the SARS-CoV-2 pandemic led to diminished numbers of acute trauma admissions in the Netherlands. The long-lasting pressing demand for resources, including ICU services, has negatively affected trauma care. Further caution is warranted regarding the increased incidence of injuries related to violence and self-harm.

An economic evaluation of triage tools for patients with suspected severe injuries in England.

BACKGROUND: Many health care systems triage injured patients to major trauma centres (MTCs) or local hospitals by using triage tools and paramedic judgement. Triage tools are typically assessed by whether patients with an Injury Severity Score (ISS) ≥ 16 go to an MTC and whether patients with an ISS < 16 are sent to their local hospital. There is a trade-off between sensitivity and specificity of triage tools, with the optimal balance being unknown. We conducted an economic evaluation of major trauma triage tools to identify which tool would be considered cost-effective by UK decision makers. METHODS: A patient-level, probabilistic, mathematical model of a UK major trauma system was developed. Patients with an ISS ≥ 16 who were only treated at local hospitals had worse outcomes compared to being treated in an MTC. Nine empirically derived triage tools, from a previous study, were examined so we assessed triage tools with realistic trade-offs between triage tool sensitivity and specificity. Lifetime costs, lifetime quality adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated for each tool and compared to maximum acceptable ICERs (MAICERs) in England. RESULTS: Four tools had ICERs within the normal range of MAICERs used by English decision makers (£20,000 to £30,000 per QALY gained). A low sensitivity (28.4%) and high specificity (88.6%) would be cost-effective at the lower end of this range while higher sensitivity (87.5%) and lower specificity (62.8%) was cost-effective towards the upper end of this range. These results were sensitive to the cost of MTC admissions and whether MTCs had a benefit for patients with an ISS between 9 and 15. CONCLUSIONS: The cost-effective triage tool depends on the English decision maker's MAICER for this health problem. In the usual range of MAICERs, cost-effective prehospital trauma triage involves clinically suboptimal sensitivity, with a proportion of seriously injured patients (at least 10%) being initially transported to local hospitals. High sensitivity trauma triage requires development of more accurate decision rules; research to establish if patients with an ISS between 9 and 15 benefit from MTCs; or, inefficient use of health care resources to manage patients with less serious injuries at MTCs.

The impact of prehospital time intervals on mortality in moderately and severely injured patients.

BACKGROUND: Modern trauma systems and emergency medical services aim to reduce prehospital time intervals to achieve optimal outcomes. However, current literature remains inconclusive on the relationship between time to definitive treatment and mortality. The aim of this study was to investigate the association between prehospital time and mortality. METHODS: All moderately and severely injured trauma patients (i.e., patients with an Injury Severity Score of 9 or greater) who were transported from the scene of injury to a trauma center by ground ambulances of the participating emergency medical services between 2015 and 2017 were included. Exposures of interest were total prehospital time, on-scene time, and transport time. Outcomes were 24-hour and 30-day mortality. Generalized linear models including inverse probability weights for several potential confounders were constructed. A generalized additive model was constructed to enable visual inspection of the association. RESULTS: We included 22,525 moderately and severely injured patients. Twenty-four-hour and 30-day mortality were 1.3% and 7.3%, respectively. On-scene time per minute was significantly associated with 24-hour (relative risk [RR], 1.029; 95% confidence interval, 1.018-1.040) and 30-day mortality (RR, 1.013; 1.008-1.017). We found that this association was also present in patients with severe injuries, traumatic brain injury, severe abdominal injury, and stab or gunshot wound. An on-scene time of 20 minutes or longer demonstrated a strong association with 24-hour (RR, 1.797; 1.406-2.296) and 30-day mortality (RR, 1.298; 1.180-1.428). Total prehospital (24-hour: RR, 0.998; 0.990-1.007; 30-day: RR, 1.000, 0.997-1.004) and transport (24-hour: RR, 0.996; 0.982-1.010; 30-day: RR, 0.995; 0.989-1.001) time were not associated with mortality. CONCLUSION: A prolonged on-scene time is associated with mortality in moderately and severely injured patients, which suggests that a reduced on-scene time may be favorable for these patients. In addition, transport time was found not to be associated with mortality. LEVEL OF EVIDENCE: Prognostic and Epidemiologic; level III.

Priority accuracy by dispatch centers and Emergency Medical Services professionals in trauma patients: a cohort study.

PURPOSE: Priority-setting by dispatch centers and Emergency Medical Services professionals has a major impact on pre-hospital triage and times of trauma patients. Patients requiring specialized care benefit from expedited transport to higher-level trauma centers, while transportation of these patients to lower-level trauma centers is associated with higher mortality rates. This study aims to evaluate the accuracy of priority-setting by dispatch centers and Emergency Medical Services professionals. METHODS: This observational study included trauma patients transported from the scene of injury to a trauma center. Priority-setting was evaluated in terms of the proportion of patients requiring specialized trauma care assigned with the highest priority (i.e., sensitivity), undertriage, and overtriage. Patients in need of specialized care were defined by a composite resource-based endpoint. An Injury Severity Score ≥ 16 served as a secondary reference standard. RESULTS: Between January 2015 and December 2017, records of 114,459 trauma patients were collected, of which 3327 (2.9%) patients were in need of specialized care according to the primary reference standard. Dispatch centers and Emergency Medical Services professionals assigned 83.8% and 74.5% of these patients with the highest priority, respectively. Undertriage rates ranged between 22.7 and 65.5% in the different prioritization subgroups. There were differences between dispatch and transport priorities in 17.7% of the patients. CONCLUSION: The majority of patients that required specialized care were assigned with the highest priority by the dispatch centers and Emergency Medical Services professionals. Highly accurate priority criteria could improve the quality of pre-hospital triage.

Evaluating the effect of driving distance to the nearest higher level trauma centre on undertriage: a cohort study.

BACKGROUND: It is of great importance that emergency medical services professionals transport trauma patients in need of specialised care to higher level trauma centres to achieve optimal patient outcomes. Possibly, undertriage is more likely to occur in patients with a longer distance to the nearest higher level trauma centre. This study aims to determine the association between driving distance and undertriage. METHOD: This prospective cohort study was conducted from January 2015 to December 2017. All trauma patients in need of specialised care that were transported to a trauma centre by emergency medical services professionals from eight ambulance regions in the Netherlands were included. Patients with critical resource use or an Injury Severity Score ≥16 were defined as in need of specialised care. Driving distance was calculated between the scene of injury and the nearest higher level trauma centre. Undertriage was defined as transporting a patient in need of specialised care to a lower level trauma centre. Generalised linear models adjusting for confounders were constructed to determine the association between driving distance to the nearest higher level trauma centre per 1 and 10 km and undertriage. A sensitivity analysis was conducted with a generalised linear model including inverse probability weights. RESULTS: 6101 patients, of which 4404 patients with critical resource use and 3760 patients with an Injury Severity Score ≥16, were included. The adjusted generalised linear model demonstrated a significant association between a 1 km (OR 1.04; 95% CI 1.04 to 1.05) and 10 kilometre (OR 1.50; 95% CI 1.42 to 1.58) increase in driving distance and undertriage in patients with critical resource use. Also in patients with an Injury Severity Score ≥16, a significant association between driving distance (1 km (OR 1.06; 95% CI 1.06 to 1.07), 10 km (OR 1.83; 95% CI 1.71 to 1.95)) and undertriage was observed. CONCLUSION: Patients in need of specialised care are less likely to be transported to the appropriate trauma centre with increasing driving distance. Our results suggest that emergency medical services professionals incorporate driving distance into their decision making regarding transport destinations, although distance is not included in the triage protocol.

In-house versus on-call trauma surgeon coverage: A systematic review and meta-analysis.

BACKGROUND: A rapid trauma response is essential to provide optimal care for severely injured patients. However, it is currently unclear if the presence of an in-house trauma surgeon affects this response during call and influences outcomes. This study compares in-hospital mortality and process-related outcomes of trauma patients treated by a 24/7 in-house versus an on-call trauma surgeon. METHODS: PubMed/Medline, Embase, and CENTRAL databases were searched on the first of November 2020. All studies comparing patients treated by a 24/7 in-house versus an on-call trauma surgeon were considered eligible for inclusion. A meta-analysis of mortality rates including all severely injured patients (i.e., Injury Severity Score of ≥16) was performed. Random-effect models were used to pool mortality rates, reported as risk ratios. The main outcome measure was in-hospital mortality. Process-related outcomes were chosen as secondary outcome measures. RESULTS: In total, 16 observational studies, combining 64,337 trauma patients, were included. The meta-analysis included 8 studies, comprising 7,490 severely injured patients. A significant reduction in mortality rate was found in patients treated in the 24/7 in-house trauma surgeon group compared with patients treated in the on-call trauma surgeon group (risk ratio, 0.86; 95% confidence interval, 0.78-0.95; p = 0.002; I2 = 0%). In 10 of 16 studies, at least 1 process-related outcome improved after the in-house trauma surgeon policy was implemented. CONCLUSION: A 24/7 in-house trauma surgeon policy is associated with reduced mortality rates for severely injured patients treated at level I trauma centers. In addition, presence of an in-house trauma surgeon during call may improve process-related outcomes. This review recommends implementation of a 24/7 in-house attending trauma surgeon at level I trauma centers. However, the final decision on attendance policy might depend on center and region-specific conditions. LEVEL OF EVIDENCE: Systematic review/meta-analysis, level III.

The impact of the Trauma Triage App on pre-hospital trauma triage: design and protocol of the stepped-wedge, cluster-randomized TESLA trial.

BACKGROUND: Field triage of trauma patients is crucial to get the right patient to the right hospital within a particular time frame. Minimization of undertriage, overtriage, and interhospital transfer rates could substantially reduce mortality rates, life-long disabilities, and costs. Identification of patients in need of specialized trauma care is predominantly based on the judgment of Emergency Medical Services professionals and a pre-hospital triage protocol. The Trauma Triage App is a smartphone application that includes a prediction model to aid Emergency Medical Services professionals in the identification of patients in need of specialized trauma care. The aim of this trial is to assess the impact of this new digital approach to field triage on the primary endpoint undertriage. METHODS: The Trauma triage using Supervised Learning Algorithms (TESLA) trial is a stepped-wedge cluster-randomized controlled trial with eight clusters defined as Emergency Medical Services regions. These clusters are an integral part of five inclusive trauma regions. Injured patients, evaluated on-scene by an Emergency Medical Services professional, suspected of moderate to severe injuries, will be assessed for eligibility. This unidirectional crossover trial will start with a baseline period in which the default pre-hospital triage protocol is used, after which all clusters gradually implement the Trauma Triage App as an add-on to the existing triage protocol. The primary endpoint is undertriage on patient and cluster level and is defined as the transportation of a severely injured patient (Injury Severity Score ≥ 16) to a lower-level trauma center. Secondary endpoints include overtriage, hospital resource use, and a cost-utility analysis. DISCUSSION: The TESLA trial will assess the impact of the Trauma Triage App in clinical practice. This novel approach to field triage will give new and previously undiscovered insights into several isolated components of the diagnostic strategy to get the right trauma patient to the right hospital. The stepped-wedge design allows for within and between cluster comparisons. TRIAL REGISTRATION: Netherlands Trial Register, NTR7243. Registered 30 May 2018, https://www.trialregister.nl/trial/7038.

Accuracy of pre-hospital trauma triage and field triage decision rules in children (P2-T2 study): an observational study.

BACKGROUND: Adequate pre-hospital trauma triage is crucial to enable optimal care in inclusive trauma systems. Transport of children in need of specialised trauma care to lower-level trauma centres is associated with adverse patient outcomes. We aimed to evaluate the diagnostic accuracy of paediatric field triage based on patient destination and triage tools. METHODS: We did a multisite observational study (P2-T2) of all children (aged <16 years) transported with high priority by ambulance from the scene of injury to any emergency department in seven of 11 inclusive trauma regions in the Netherlands. Diagnostic accuracy based on the initial transport destination was evaluated in terms of undertriage rate (ie, the proportion of patients in need of specialised trauma care who were initially transported to a lower-level paediatric or adult trauma centre) and overtriage rate (ie, the proportion of patients not requiring specialised trauma care who were transported to a level-I [highest level] paediatric trauma centre). The Dutch National Protocol of Ambulance Services and Field Triage Decision Scheme triage protocols were externally validated using data from this cohort against an anatomical (Injury Severity Score [ISS] ≥16) and a resource-based reference standard. FINDINGS: Between Jan 1, 2015, and Dec 31, 2017, 12 915 children (median age 10·3 years, IQR 4·2-13·6) were transported to the emergency department with injuries. 4091 (31·7%) patients were admitted to hospital, of whom 129 (3·2%) patients had an ISS of 16 or greater and 227 (5·5%) patients used critical resources within a limited timeframe. Ten patients died within 24 h of arrival at the emergency department. Based on the primary reference standard (ISS ≥16), the undertriage rate was 16·3% (95% CI 10·8-23·7) and the overtriage rate was 21·2% (20·5-22·0). The National Protocol of Ambulance Services had a sensitivity of 53·5% (95% CI 43·9-62·9) and a specificity of 94·0% (93·4-94·6), and the Field Triage Decision Scheme had a sensitivity of 64·5% (54·1-74·1) and a specificity of 84·3% (83·1-85·5). INTERPRETATION: Too many children in need of specialised care were transported to lower-level paediatric or adult trauma centres, which is associated with increased mortality and morbidity. Current protocols cannot accurately discriminate between patients at low and high risk, and highly sensitive and child-specific triage tools need to be developed to ensure the right patient is transported to the right hospital. FUNDING: The Netherlands Organisation for Health Research and Development, Innovation Fund Health Insurers.

Simultaneous occurrence of ankylosing spondylitis and diffuse idiopathic skeletal hyperostosis: a systematic review.

Objectives: AS and DISH are both spinal ankylosing conditions with a 4-fold increased risk of spinal fractures. The most commonly used criteria for DISH were designed to exclude radiographic signs of spondyloarthritis. However, case reports describing the presence of both conditions exist. In this study, the co-occurrence of AS and DISH were reviewed in the literature to explore the potential need to revise the criteria for DISH. Methods: A search was conducted in Pubmed, Embase, Web of Science and the Cochrane library using the terms 'spondyloarthritis' and 'DISH' and their matching synonyms. Full-text articles describing the coexistence of both conditions in the same patient were included. A quality assessment was performed, and the case descriptions were extracted. Results: Twenty articles describing simultaneous occurrence of AS and DISH in 39 cases were retrieved. All articles were case reports or series of moderate quality. Back or neck pain was present in 97% of the patients (mean age 61.2 years, 90% male) and HLA-B27 was positive in 9/27 documented measurements. Radiographic abnormalities were described in the SI joint (82% AS, 13% DISH) and in the spine (49% AS, 100% DISH). Conclusion: Simultaneous occurrence of AS and DISH has been reported in the literature in at least 39 cases. AS and DISH should not be seen as mutually exclusive. If the results of the current study are confirmed in a large observational study, revision of the current criteria to include the co-existence of both conditions should be considered.