F. Berger

[Randomized clinical trials in trauma surgery: decision-making in an area of conflict between eminence and evidence].

Well-designed, prospective, multicenter, randomized clinical trials (RCTs) define the gold standard of evidence-based medicine. The results of such trials represent the most solid rationale for therapeutic recommendations in the S3 guideline of medical societies (http://www.leitlinie.de). The performance of studies according to good clinical practice (GCP) guidelines (Guidelines of the International Conference on Harmonization on Good Clinical Practice) is extremely demanding. The findings can shake long established principles and practices to the core. For more than 20 years now, the management of femoral shaft fractures in critically injured patients has been controversially discussed. There are two different concepts competing against each other: Early total care (ETC) aiming at definitive care by immediate femoral nailing and damage control orthopedics (DCO), where nailing is performed at a later time point after initial retention by the use of external fixation. In order to answer this still unresolved question, the Damage Control Study is currently under way involving 25 trauma centers throughout Germany. This study is funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Association), it is endorsed by the board of Deutschen Gesellschaft für Unfallchirurgie (DGU, German Society for Casualty Surgery) and it is embedded in a joint program of the DFG and the Federal Ministry of Education and Research (BMBF) to support clinical studies in Germany. Moreover, the study is supported by the ChirNet Site at Witten/Herdecke-Köln (http://www.chir-net.de). Without a doubt, this RCT is one of the most important studies carried out in the field of care for the critically injured patient, because the results will have a profound influence on the future management of femoral shaft fractures in multiple trauma patients and because successful completion of this study will underline the high scientific competence and skills claimed by German trauma surgeons. At the same time, ironically, the success of this study is endangered by the dilemma of an as yet insufficient recruitment of suitable patients to be enrolled into the trial. In this article possible explanations for this problem will be discussed based on a case report and the specific challenges in performing RCTs that scrutinize questions in the field of surgery will be analyzed.

Randomisierte klinische Studien in der Unfallchirurgie

Well-designed, prospective, multicenter, randomized clinical trials (RCTs) define the gold standard of evidence-based medicine. The results of such trials represent the most solid rationale for therapeutic recommendations in the S3 guideline of medical societies (http://www.leitlinie.de). The performance of studies according to good clinical practice (GCP) guidelines (Guidelines of the International Conference on Harmonization on Good Clinical Practice) is extremely demanding. The findings can shake long established principles and practices to the core. For more than 20 years now, the management of femoral shaft fractures in critically injured patients has been controversially discussed. There are two different concepts competing against each other: Early total care (ETC) aiming at definitive care by immediate femoral nailing and damage control orthopedics (DCO), where nailing is performed at a later time point after initial retention by the use of external fixation. In order to answer this still unresolved question, the Damage Control Study is currently under way involving 25 trauma centers throughout Germany. This study is funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Association), it is endorsed by the board of Deutschen Gesellschaft für Unfallchirurgie (DGU, German Society for Casualty Surgery) and it is embedded in a joint program of the DFG and the Federal Ministry of Education and Research (BMBF) to support clinical studies in Germany. Moreover, the study is supported by the ChirNet Site at Witten/Herdecke-Köln (http://www.chir-net.de). Without a doubt, this RCT is one of the most important studies carried out in the field of care for the critically injured patient, because the results will have a profound influence on the future management of femoral shaft fractures in multiple trauma patients and because successful completion of this study will underline the high scientific competence and skills claimed by German trauma surgeons. At the same time, ironically, the success of this study is endangered by the dilemma of an as yet insufficient recruitment of suitable patients to be enrolled into the trial. In this article possible explanations for this problem will be discussed based on a case report and the specific challenges in performing RCTs that scrutinize questions in the field of surgery will be analyzed.

Retrospektive Berechnung des ISS bei polytraumatisierten Patienten Fehlerquellen und Anforderungen an den radiologischen Befund der Ganzkörper-CT

INTRODUCTION The Injury Severity Score (ISS) is a well-established anatomical scoring system for polytraumatized patients. However, any inaccuracy in the Abbreviated Injury Score (AIS) directly increases the ISS impreciseness. Using the full body computed tomography (CT) scan report, ISS computation can be associated with certain pitfalls. This study evaluates interpretation variations depending on radiological reports and indicates requirements to reliably determine the ISS. MATERIALS AND METHODS The ISS of 81 polytraumatized patients was calculated based on the full body CT scan report. If an injury could not be attributed to a precise AIS cipher, the minimal and maximal ISS was computed. Real ISS included all conducted investigations, intraoperative findings, and final medical reports. The differences in ISS min, ISS max, and ISS real were evaluated using the Kruskal-Wallis test (p<0.05) and plotted in a linear regression analysis. RESULTS Mean ISS min was 24.0 (± 0.7 SEM) points, mean ISS real 38.6 (±1.3 SEM) and mean ISS max was 48.3 (±1.4 SEM) points. All means were significantly different compared to one another (p<0.001). The difference between possible and real ISS showed a distinctive variation. Mean deviation was 9.7 (±0.9 SEM) points downward and 14.5 (±1.1 SEM) points upward. The difference between deviation to ISS min and ISS max was highly significant (p<0.001). CONCLUSION Objectification of injury severity in polytraumatized patients using the ISS is an internationally well-established method in clinical and scientific settings. The full body CT scan report must meet distinct criteria and has to be written in acquaintance to the AIS scale if intended to be used for correct ISS computation.

Retrospektive Berechnung des ISS bei polytraumatisierten Patienten@@@Retrospective computation of the ISS in multiple trauma patients: Fehlerquellen und Anforderungen an den radiologischen Befund der Ganzkörper-CT@@@Potential pitfalls and limitations of findings in full body CT scans

INTRODUCTION The Injury Severity Score (ISS) is a well-established anatomical scoring system for polytraumatized patients. However, any inaccuracy in the Abbreviated Injury Score (AIS) directly increases the ISS impreciseness. Using the full body computed tomography (CT) scan report, ISS computation can be associated with certain pitfalls. This study evaluates interpretation variations depending on radiological reports and indicates requirements to reliably determine the ISS. MATERIALS AND METHODS The ISS of 81 polytraumatized patients was calculated based on the full body CT scan report. If an injury could not be attributed to a precise AIS cipher, the minimal and maximal ISS was computed. Real ISS included all conducted investigations, intraoperative findings, and final medical reports. The differences in ISS min, ISS max, and ISS real were evaluated using the Kruskal-Wallis test (p<0.05) and plotted in a linear regression analysis. RESULTS Mean ISS min was 24.0 (± 0.7 SEM) points, mean ISS real 38.6 (±1.3 SEM) and mean ISS max was 48.3 (±1.4 SEM) points. All means were significantly different compared to one another (p<0.001). The difference between possible and real ISS showed a distinctive variation. Mean deviation was 9.7 (±0.9 SEM) points downward and 14.5 (±1.1 SEM) points upward. The difference between deviation to ISS min and ISS max was highly significant (p<0.001). CONCLUSION Objectification of injury severity in polytraumatized patients using the ISS is an internationally well-established method in clinical and scientific settings. The full body CT scan report must meet distinct criteria and has to be written in acquaintance to the AIS scale if intended to be used for correct ISS computation.

Retrospektive Berechnung des ISS bei polytraumatisierten Patienten

INTRODUCTION The Injury Severity Score (ISS) is a well-established anatomical scoring system for polytraumatized patients. However, any inaccuracy in the Abbreviated Injury Score (AIS) directly increases the ISS impreciseness. Using the full body computed tomography (CT) scan report, ISS computation can be associated with certain pitfalls. This study evaluates interpretation variations depending on radiological reports and indicates requirements to reliably determine the ISS. MATERIALS AND METHODS The ISS of 81 polytraumatized patients was calculated based on the full body CT scan report. If an injury could not be attributed to a precise AIS cipher, the minimal and maximal ISS was computed. Real ISS included all conducted investigations, intraoperative findings, and final medical reports. The differences in ISS min, ISS max, and ISS real were evaluated using the Kruskal-Wallis test (p<0.05) and plotted in a linear regression analysis. RESULTS Mean ISS min was 24.0 (± 0.7 SEM) points, mean ISS real 38.6 (±1.3 SEM) and mean ISS max was 48.3 (±1.4 SEM) points. All means were significantly different compared to one another (p<0.001). The difference between possible and real ISS showed a distinctive variation. Mean deviation was 9.7 (±0.9 SEM) points downward and 14.5 (±1.1 SEM) points upward. The difference between deviation to ISS min and ISS max was highly significant (p<0.001). CONCLUSION Objectification of injury severity in polytraumatized patients using the ISS is an internationally well-established method in clinical and scientific settings. The full body CT scan report must meet distinct criteria and has to be written in acquaintance to the AIS scale if intended to be used for correct ISS computation.

Retrospective computation of the ISS in multiple trauma patients : potential pitfalls and limitations of findings in full body CT scans

INTRODUCTION The Injury Severity Score (ISS) is a well-established anatomical scoring system for polytraumatized patients. However, any inaccuracy in the Abbreviated Injury Score (AIS) directly increases the ISS impreciseness. Using the full body computed tomography (CT) scan report, ISS computation can be associated with certain pitfalls. This study evaluates interpretation variations depending on radiological reports and indicates requirements to reliably determine the ISS. MATERIALS AND METHODS The ISS of 81 polytraumatized patients was calculated based on the full body CT scan report. If an injury could not be attributed to a precise AIS cipher, the minimal and maximal ISS was computed. Real ISS included all conducted investigations, intraoperative findings, and final medical reports. The differences in ISS min, ISS max, and ISS real were evaluated using the Kruskal-Wallis test (p<0.05) and plotted in a linear regression analysis. RESULTS Mean ISS min was 24.0 (± 0.7 SEM) points, mean ISS real 38.6 (±1.3 SEM) and mean ISS max was 48.3 (±1.4 SEM) points. All means were significantly different compared to one another (p<0.001). The difference between possible and real ISS showed a distinctive variation. Mean deviation was 9.7 (±0.9 SEM) points downward and 14.5 (±1.1 SEM) points upward. The difference between deviation to ISS min and ISS max was highly significant (p<0.001). CONCLUSION Objectification of injury severity in polytraumatized patients using the ISS is an internationally well-established method in clinical and scientific settings. The full body CT scan report must meet distinct criteria and has to be written in acquaintance to the AIS scale if intended to be used for correct ISS computation.

Randomisierte klinische Studien in der Unfallchirurgie@@@Randomized clinical trials in trauma surgery: Entscheidungsfindung im Spannungsfeld zwischen Eminenz und Evidenz@@@Decision-making in an area of conflict between eminence and evidence

Well-designed, prospective, multicenter, randomized clinical trials (RCTs) define the gold standard of evidence-based medicine. The results of such trials represent the most solid rationale for therapeutic recommendations in the S3 guideline of medical societies (http://www.leitlinie.de). The performance of studies according to good clinical practice (GCP) guidelines (Guidelines of the International Conference on Harmonization on Good Clinical Practice) is extremely demanding. The findings can shake long established principles and practices to the core. For more than 20 years now, the management of femoral shaft fractures in critically injured patients has been controversially discussed. There are two different concepts competing against each other: Early total care (ETC) aiming at definitive care by immediate femoral nailing and damage control orthopedics (DCO), where nailing is performed at a later time point after initial retention by the use of external fixation. In order to answer this still unresolved question, the Damage Control Study is currently under way involving 25 trauma centers throughout Germany. This study is funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Association), it is endorsed by the board of Deutschen Gesellschaft für Unfallchirurgie (DGU, German Society for Casualty Surgery) and it is embedded in a joint program of the DFG and the Federal Ministry of Education and Research (BMBF) to support clinical studies in Germany. Moreover, the study is supported by the ChirNet Site at Witten/Herdecke-Köln (http://www.chir-net.de). Without a doubt, this RCT is one of the most important studies carried out in the field of care for the critically injured patient, because the results will have a profound influence on the future management of femoral shaft fractures in multiple trauma patients and because successful completion of this study will underline the high scientific competence and skills claimed by German trauma surgeons. At the same time, ironically, the success of this study is endangered by the dilemma of an as yet insufficient recruitment of suitable patients to be enrolled into the trial. In this article possible explanations for this problem will be discussed based on a case report and the specific challenges in performing RCTs that scrutinize questions in the field of surgery will be analyzed.