human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: OBJECTIVE The aim of this study was to evaluate the predictive value of cerebral regional oxygen saturation ( rSO(2 ) ) in the occurrence of postoperative cognitive dysfunction ( POCD ) in elderly patients undergoing coronary artery bypass graft ( CABG ) surgery .  DESIGN A prospect i ve study . SETTING University hospital . PARTICIPANTS A total of 61 patients ( 84 % male ) with a mean age of 70.39 ± 4.69 on a waiting list for CABG surgery were enrolled in the study . INTERVENTION A  complete neurocognitive evaluation was performed 1 day before surgery as well as 4 to 7 days and 1 month after surgery . During surgery , rSO(2 ) was monitored continuously . MEASUREMENTS AND MAIN RESULTS POCD was defined as a reduction of 1 st and ard deviation on 2 or more neuropsychologic indices . Forty-six patients ( 80.7 % ) developed early POCD , and 23 ( 38.3 % ) showed late POCD . Patients whose rSO(2 ) decreased to less than 50 % during the surgery experienced more POCD 4 to 7 days after surgery ( p = 0.04 ) . In addition , a decrease of more than 30 % from the patient 's baseline rSO(2 ) was associated with POCD 1 month after surgery ( p = 0.03 ) . CONCLUSION Intraoperative cerebral oxygen desaturation is associated with early and late POCD in elderly patients . Cerebral oximetry is a promising tool in the prediction of subtle neuropsychologic deficits and further studies are needed Objective To determine if it is possible to stabilise the cerebral oxygenation of extremely preterm infants monitored by cerebral near infrared spectroscopy ( NIRS ) oximetry . Design Phase II r and omised , single blinded , parallel clinical trial . Setting Eight tertiary neonatal intensive care units in eight European countries . Participants 166 extremely preterm infants born before 28 weeks of gestation : 86 were r and omised to cerebral NIRS monitoring and 80 to blinded NIRS monitoring .  The only exclusion criterion was a decision not to provide life support . Interventions Monitoring of cerebral oxygenation using NIRS in combination with a dedicated treatment guideline during the first 72 hours of life ( experimental ) compared with blinded NIRS oxygenation monitoring with st and ard care ( control ) . Main outcome measures The primary outcome measure was the time spent outside the target range of 55 - 85 % for cerebral oxygenation multiplied by the mean absolute deviation , expressed in % hours ( burden of hypoxia and hyperoxia ) . One hour with an oxygenation of 50 % gives 5%hours of hypoxia . Secondary outcomes were all cause mortality at term equivalent age and a brain injury score assessed by cerebral ultrasonography . R and omisation Allocation sequence 1:1 with block sizes 4 and 6 in r and om order concealed for the investigators . The allocation was stratified for gestational age ( < 26 weeks or ≥26 weeks ) . Blinding Cerebral oxygenation measurements were blinded in the control group . All outcome assessors were blinded to group allocation . Results The 86 infants r and omised to the NIRS group had a median burden of hypoxia and hyperoxia of 36.1%hours ( interquartile range 9.2 - 79.5%hours ) compared with 81.3 ( 38.5 - 181.3 ) % hours in the control group , a reduction of 58 % ( 95 % confidence interval 35 % to 73 % , P<0.001 ) . In the experimental group the median burden of hypoxia was 16.6 ( interquartile range 5.4 - 68.1 ) % hours , compared with 53.6 ( 17.4 - 171.3 ) % hours in the control group ( P=0.0012 ) . The median burden of hyperoxia was similar between the groups : 1.2 ( interquartile range 0.3 - 9.6 ) % hours in the experimental group compared with 1.1 ( 0.1 - 23.4 ) % hours in the control group ( P=0.98 ) . We found no statistically significant differences between the two groups at term corrected age . No severe adverse reactions were associated with the device . Conclusions Cerebral oxygenation was stabilised in extremely preterm infants using a dedicated treatment guideline in combination with cerebral NIRS monitoring . Trial registration Clinical Trial.gov NCT01590316 BACKGROUND There are limited data to inform the choice between early treatment with continuous positive airway pressure ( CPAP ) and early surfactant treatment as the initial support for extremely-low-birth-weight infants . METHODS We performed a r and omized , multicenter trial , with a 2-by-2 factorial design , involving infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation . Infants were r and omly assigned to intubation and surfactant treatment ( within 1 hour after birth ) or to CPAP treatment initiated in the delivery room , with subsequent use of a protocol -driven limited ventilation strategy . Infants were also r and omly assigned to one of two target ranges of oxygen saturation . The primary outcome was death or bronchopulmonary dysplasia as defined by the requirement for supplemental oxygen at 36 weeks ( with an attempt at withdrawal of supplemental oxygen in neonates who were receiving less than 30 % oxygen ) . RESULTS A total of 1316 infants were enrolled in the study . The rates of the primary outcome did not differ significantly between the CPAP group and the surfactant group ( 47.8 % and 51.0 % , respectively ; relative risk with CPAP , 0.95 ; 95 % confidence interval [ CI ] , 0.85 to 1.05 ) after adjustment for gestational age , center , and familial clustering . The results were similar when bronchopulmonary dysplasia was defined according to the need for any supplemental oxygen at 36 weeks ( rates of primary outcome , 48.7 % and 54.1 % , respectively ; relative risk with CPAP , 0.91 ; 95 % CI , 0.83 to 1.01 ) . Infants who received CPAP treatment , as compared with infants who received surfactant treatment , less frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia ( P<0.001 ) , required fewer days of mechanical ventilation ( P=0.03 ) , and were more likely to be alive and free from the need for mechanical ventilation by day 7 ( P=0.01 ) . The rates of other adverse neonatal outcomes did not differ significantly between the two groups . CONCLUSIONS The results of this study support consideration of CPAP as an alternative to intubation and surfactant in preterm infants . ( Clinical Trials.gov number , NCT00233324 . Adequate reporting of r and omized , controlled trials ( RCTs ) is necessary to allow accurate critical appraisal of the validity and applicability of the results . The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement , a 22-item checklist and flow diagram , is intended to address this problem by improving the reporting of RCTs . However , some specific issues that apply to trials of nonpharmacologic treatments ( for example , surgery , technical interventions , devices , rehabilitation , psychotherapy , and behavioral intervention ) are not specifically addressed in the CONSORT Statement . Furthermore , considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement . Therefore , the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments . A consensus meeting of 33 experts was organized in Paris , France , in February 2006 , to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments . The participants extended 11 items from the CONSORT Statement , added 1 item , and developed a modified flow diagram . To allow adequate underst and ing and implementation of the CONSORT extension , the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting . This extension , in conjunction with the main CONSORT Statement and other CONSORT extensions , should help to improve the reporting of RCTs performed in this field Near-infrared spectroscopy-derived regional tissue oxygen saturation of haemoglobin ( rStO2 ) reflects venous oxygen saturation . If cerebral metabolism is stable , rStO2 can be used as an estimate of cerebral oxygen delivery . The SafeBoosC phase II r and omised clinical trial hypothesises that the burden of hypo- and hyperoxia can be reduced by the combined use of close monitoring of the cerebral rStO2 and a treatment guideline to correct deviations in rStO2 outside a predefined target range . Aims : To describe the rationale for and content of this treatment guideline . Methods : Review of the literature and assessment of the quality of evidence and the grade of recommendation for each of the interventions . Results and Conclusions : A clinical intervention algorithm based on the main determinants of cerebral perfusion-oxygenation changes during the first hours after birth was generated . The treatment guideline is presented to assist neonatologists in making decisions in relation to cerebral oximetry readings in preterm infants within the SafeBoosC phase II r and omised clinical trial . The evidence grade s were relatively low and the guideline can not be recommended outside a research setting One cause of cerebral damage in comatose patients resuscitated from a cardiac arrest is cerebral ischaemia occurring during the postresuscitation period . Near‐infrared spectroscopy has been advocated as a useful monitor of brain oxygenation , but data on clinical use in comatose postarrest patients are not available . Therefore , we compared regional oxygen saturation measured with the INVOS 3100 with global oxygen saturation measured using jugular bulb oximetry in 10 comatose patients successfully resuscitated from an out‐of‐hospital cardiac arrest . Our data show that , in most patients , there is a significant difference between the two methods . The INVOS 3100 over‐read at low jugular bulb saturations ( < 60 % ) and under‐read at high jugular bulb saturations ( ≥ 60 % ) . During hypoventilation we found a significant increase in regional oxygen saturation . This increase was significantly correlated with the rise in cerebral blood flow and cardiac index , indicating that regional oxygen saturation is influenced by both cerebral and extracerebral components . We conclude that regional cerebral oxygen saturation measured with the INVOS 3100 can not be compared with global cerebral oxygen saturation measured with jugular bulb oximetry in comatose patients resuscitated from a cardiac arrest . This may be due to characteristics of the INVOS 3100 or to the distribution of cerebral blood flow after cardiac arrest R and omized clinical trials ( RCTs ) have revolutionized medicine by providing evidence on the efficacy and safety of drugs , devices , and procedures . Today , more than 40 000 RCTs are reported annually , their quality continues to increase , and oversight mechanisms ensure adequate protection of participants . However , RCTs have at least 4 related problems : ( 1 ) they are too expensive and difficult ; ( 2 ) their findings are too broad ( average treatment effect not representative of benefit for any given individual ) and too narrow ( trial population and setting not representative of general practice ) ; ( 3 ) r and omizing patients can make patients and physicians uncomfortable , especially when comparing different types of existing care ; and ( 4 ) there are often long delays before RCT results diffuse into practice . The new alternative is “ big data . ” Because medical care is increasingly digitized in electronic health record ( EHR ) data sets and linked biological and genetic data banks , proponents suggest that health care systems are at the dawn of an era in which a patient ’s prognosis and optimal therapy will be generated from rapid analysis of these data sets using sophisticated machinelearning strategies . The information is relatively inexpensive , generated as a by-product of patient care ( overcoming the cost problem ) , and both specific to individuals ( ie , adequately narrow ) and , en masse , descriptive of the entire delivery system ( ie , adequately broad ) . No individuals are r and omized , so the ethical issues appear less complex . The richness and immediacy of these new data could allow tailored treatment decisions in real time , overcoming delays in knowledge translation . As such , although the RCT remains the gold st and ard for evaluation of experimental therapies , big data is proposed as a better approach for the broad swath of comparative effectiveness questions that arise in clinical practice . Indeed , the Institute of Medicine envisions big data as the engine for so-called learning health care systems.1 Yet big data is not a replacement for the RCT . The singular beauty of the RCT is the strength of causal inference that arises from r and om assignment . All known and unknown factors that can influence outcome , other than the treatment assignment , are distributed r and omly— and , if r and omization is effective , evenly — among the groups . Thus , any statistical difference in outcome between groups can be attributed to the assigned interventions . In contrast , big data exploits variation that may appear r and om but is not in fact r and omized . For example , big data may compare patients who did or did not receive a particular drug and then attempt to determine the extent to which any difference in patient outcome may be related to receiving the drug . However , for all the allure of inexpensive access to massive amounts of data , the Achilles ’ heel is lack of causal inference . No matter how detailed the measurement and how sophisticated the adjustment for all known variables , big data can not eliminate unmeasured factors coincident with a particular treatment assignment that could explain an apparent change in outcome .2 Thus 
    Output:
    
agent
The only eligible r and omised clinical trial did not demonstrate any consistent effects of NIRS plus a guideline on the assessed clinical outcomes .
The trial was , however , only powered to detect difference in cerebral oxygenation , not morbidities or mortality .
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: OBJECTIVE The aim of this study was to evaluate the predictive value of cerebral regional oxygen saturation ( rSO(2 ) ) in the occurrence of postoperative cognitive dysfunction ( POCD ) in elderly patients undergoing coronary artery bypass graft ( CABG ) surgery .  DESIGN A prospect i ve study . SETTING University hospital . PARTICIPANTS A total of 61 patients ( 84 % male ) with a mean age of 70.39 ± 4.69 on a waiting list for CABG surgery were enrolled in the study . INTERVENTION A  complete neurocognitive evaluation was performed 1 day before surgery as well as 4 to 7 days and 1 month after surgery . During surgery , rSO(2 ) was monitored continuously . MEASUREMENTS AND MAIN RESULTS POCD was defined as a reduction of 1 st and ard deviation on 2 or more neuropsychologic indices . Forty-six patients ( 80.7 % ) developed early POCD , and 23 ( 38.3 % ) showed late POCD . Patients whose rSO(2 ) decreased to less than 50 % during the surgery experienced more POCD 4 to 7 days after surgery ( p = 0.04 ) . In addition , a decrease of more than 30 % from the patient 's baseline rSO(2 ) was associated with POCD 1 month after surgery ( p = 0.03 ) . CONCLUSION Intraoperative cerebral oxygen desaturation is associated with early and late POCD in elderly patients . Cerebral oximetry is a promising tool in the prediction of subtle neuropsychologic deficits and further studies are needed Objective To determine if it is possible to stabilise the cerebral oxygenation of extremely preterm infants monitored by cerebral near infrared spectroscopy ( NIRS ) oximetry . Design Phase II r and omised , single blinded , parallel clinical trial . Setting Eight tertiary neonatal intensive care units in eight European countries . Participants 166 extremely preterm infants born before 28 weeks of gestation : 86 were r and omised to cerebral NIRS monitoring and 80 to blinded NIRS monitoring .  The only exclusion criterion was a decision not to provide life support . Interventions Monitoring of cerebral oxygenation using NIRS in combination with a dedicated treatment guideline during the first 72 hours of life ( experimental ) compared with blinded NIRS oxygenation monitoring with st and ard care ( control ) . Main outcome measures The primary outcome measure was the time spent outside the target range of 55 - 85 % for cerebral oxygenation multiplied by the mean absolute deviation , expressed in % hours ( burden of hypoxia and hyperoxia ) . One hour with an oxygenation of 50 % gives 5%hours of hypoxia . Secondary outcomes were all cause mortality at term equivalent age and a brain injury score assessed by cerebral ultrasonography . R and omisation Allocation sequence 1:1 with block sizes 4 and 6 in r and om order concealed for the investigators . The allocation was stratified for gestational age ( < 26 weeks or ≥26 weeks ) . Blinding Cerebral oxygenation measurements were blinded in the control group . All outcome assessors were blinded to group allocation . Results The 86 infants r and omised to the NIRS group had a median burden of hypoxia and hyperoxia of 36.1%hours ( interquartile range 9.2 - 79.5%hours ) compared with 81.3 ( 38.5 - 181.3 ) % hours in the control group , a reduction of 58 % ( 95 % confidence interval 35 % to 73 % , P<0.001 ) . In the experimental group the median burden of hypoxia was 16.6 ( interquartile range 5.4 - 68.1 ) % hours , compared with 53.6 ( 17.4 - 171.3 ) % hours in the control group ( P=0.0012 ) . The median burden of hyperoxia was similar between the groups : 1.2 ( interquartile range 0.3 - 9.6 ) % hours in the experimental group compared with 1.1 ( 0.1 - 23.4 ) % hours in the control group ( P=0.98 ) . We found no statistically significant differences between the two groups at term corrected age . No severe adverse reactions were associated with the device . Conclusions Cerebral oxygenation was stabilised in extremely preterm infants using a dedicated treatment guideline in combination with cerebral NIRS monitoring . Trial registration Clinical Trial.gov NCT01590316 BACKGROUND There are limited data to inform the choice between early treatment with continuous positive airway pressure ( CPAP ) and early surfactant treatment as the initial support for extremely-low-birth-weight infants . METHODS We performed a r and omized , multicenter trial , with a 2-by-2 factorial design , involving infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation . Infants were r and omly assigned to intubation and surfactant treatment ( within 1 hour after birth ) or to CPAP treatment initiated in the delivery room , with subsequent use of a protocol -driven limited ventilation strategy . Infants were also r and omly assigned to one of two target ranges of oxygen saturation . The primary outcome was death or bronchopulmonary dysplasia as defined by the requirement for supplemental oxygen at 36 weeks ( with an attempt at withdrawal of supplemental oxygen in neonates who were receiving less than 30 % oxygen ) . RESULTS A total of 1316 infants were enrolled in the study . The rates of the primary outcome did not differ significantly between the CPAP group and the surfactant group ( 47.8 % and 51.0 % , respectively ; relative risk with CPAP , 0.95 ; 95 % confidence interval [ CI ] , 0.85 to 1.05 ) after adjustment for gestational age , center , and familial clustering . The results were similar when bronchopulmonary dysplasia was defined according to the need for any supplemental oxygen at 36 weeks ( rates of primary outcome , 48.7 % and 54.1 % , respectively ; relative risk with CPAP , 0.91 ; 95 % CI , 0.83 to 1.01 ) . Infants who received CPAP treatment , as compared with infants who received surfactant treatment , less frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia ( P<0.001 ) , required fewer days of mechanical ventilation ( P=0.03 ) , and were more likely to be alive and free from the need for mechanical ventilation by day 7 ( P=0.01 ) . The rates of other adverse neonatal outcomes did not differ significantly between the two groups . CONCLUSIONS The results of this study support consideration of CPAP as an alternative to intubation and surfactant in preterm infants . ( Clinical Trials.gov number , NCT00233324 . Adequate reporting of r and omized , controlled trials ( RCTs ) is necessary to allow accurate critical appraisal of the validity and applicability of the results . The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement , a 22-item checklist and flow diagram , is intended to address this problem by improving the reporting of RCTs . However , some specific issues that apply to trials of nonpharmacologic treatments ( for example , surgery , technical interventions , devices , rehabilitation , psychotherapy , and behavioral intervention ) are not specifically addressed in the CONSORT Statement . Furthermore , considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement . Therefore , the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments . A consensus meeting of 33 experts was organized in Paris , France , in February 2006 , to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments . The participants extended 11 items from the CONSORT Statement , added 1 item , and developed a modified flow diagram . To allow adequate underst and ing and implementation of the CONSORT extension , the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting . This extension , in conjunction with the main CONSORT Statement and other CONSORT extensions , should help to improve the reporting of RCTs performed in this field Near-infrared spectroscopy-derived regional tissue oxygen saturation of haemoglobin ( rStO2 ) reflects venous oxygen saturation . If cerebral metabolism is stable , rStO2 can be used as an estimate of cerebral oxygen delivery . The SafeBoosC phase II r and omised clinical trial hypothesises that the burden of hypo- and hyperoxia can be reduced by the combined use of close monitoring of the cerebral rStO2 and a treatment guideline to correct deviations in rStO2 outside a predefined target range . Aims : To describe the rationale for and content of this treatment guideline . Methods : Review of the literature and assessment of the quality of evidence and the grade of recommendation for each of the interventions . Results and Conclusions : A clinical intervention algorithm based on the main determinants of cerebral perfusion-oxygenation changes during the first hours after birth was generated . The treatment guideline is presented to assist neonatologists in making decisions in relation to cerebral oximetry readings in preterm infants within the SafeBoosC phase II r and omised clinical trial . The evidence grade s were relatively low and the guideline can not be recommended outside a research setting One cause of cerebral damage in comatose patients resuscitated from a cardiac arrest is cerebral ischaemia occurring during the postresuscitation period . Near‐infrared spectroscopy has been advocated as a useful monitor of brain oxygenation , but data on clinical use in comatose postarrest patients are not available . Therefore , we compared regional oxygen saturation measured with the INVOS 3100 with global oxygen saturation measured using jugular bulb oximetry in 10 comatose patients successfully resuscitated from an out‐of‐hospital cardiac arrest . Our data show that , in most patients , there is a significant difference between the two methods . The INVOS 3100 over‐read at low jugular bulb saturations ( < 60 % ) and under‐read at high jugular bulb saturations ( ≥ 60 % ) . During hypoventilation we found a significant increase in regional oxygen saturation . This increase was significantly correlated with the rise in cerebral blood flow and cardiac index , indicating that regional oxygen saturation is influenced by both cerebral and extracerebral components . We conclude that regional cerebral oxygen saturation measured with the INVOS 3100 can not be compared with global cerebral oxygen saturation measured with jugular bulb oximetry in comatose patients resuscitated from a cardiac arrest . This may be due to characteristics of the INVOS 3100 or to the distribution of cerebral blood flow after cardiac arrest R and omized clinical trials ( RCTs ) have revolutionized medicine by providing evidence on the efficacy and safety of drugs , devices , and procedures . Today , more than 40 000 RCTs are reported annually , their quality continues to increase , and oversight mechanisms ensure adequate protection of participants . However , RCTs have at least 4 related problems : ( 1 ) they are too expensive and difficult ; ( 2 ) their findings are too broad ( average treatment effect not representative of benefit for any given individual ) and too narrow ( trial population and setting not representative of general practice ) ; ( 3 ) r and omizing patients can make patients and physicians uncomfortable , especially when comparing different types of existing care ; and ( 4 ) there are often long delays before RCT results diffuse into practice . The new alternative is “ big data . ” Because medical care is increasingly digitized in electronic health record ( EHR ) data sets and linked biological and genetic data banks , proponents suggest that health care systems are at the dawn of an era in which a patient ’s prognosis and optimal therapy will be generated from rapid analysis of these data sets using sophisticated machinelearning strategies . The information is relatively inexpensive , generated as a by-product of patient care ( overcoming the cost problem ) , and both specific to individuals ( ie , adequately narrow ) and , en masse , descriptive of the entire delivery system ( ie , adequately broad ) . No individuals are r and omized , so the ethical issues appear less complex . The richness and immediacy of these new data could allow tailored treatment decisions in real time , overcoming delays in knowledge translation . As such , although the RCT remains the gold st and ard for evaluation of experimental therapies , big data is proposed as a better approach for the broad swath of comparative effectiveness questions that arise in clinical practice . Indeed , the Institute of Medicine envisions big data as the engine for so-called learning health care systems.1 Yet big data is not a replacement for the RCT . The singular beauty of the RCT is the strength of causal inference that arises from r and om assignment . All known and unknown factors that can influence outcome , other than the treatment assignment , are distributed r and omly— and , if r and omization is effective , evenly — among the groups . Thus , any statistical difference in outcome between groups can be attributed to the assigned interventions . In contrast , big data exploits variation that may appear r and om but is not in fact r and omized . For example , big data may compare patients who did or did not receive a particular drug and then attempt to determine the extent to which any difference in patient outcome may be related to receiving the drug . However , for all the allure of inexpensive access to massive amounts of data , the Achilles ’ heel is lack of causal inference . No matter how detailed the measurement and how sophisticated the adjustment for all known variables , big data can not eliminate unmeasured factors coincident with a particular treatment assignment that could explain an apparent change in outcome .2 Thus 
    Output:
    