Relationship between volume and outcome for gastroschisis: A systematic review.

BACKGROUND: Newborns with gastroschisis need surgery to reduce intestines into the abdominal cavity and to close the abdominal wall. Due to an existing volume-outcome relationship for other high-risk, low-volume procedures, we aimed at examining the relationship between hospital or surgeon volume and outcomes for gastroschisis. METHODS: We conducted a systematic literature search in Medline, Embase, CENTRAL, CINAHL and Biosis Previews in June 2021 and searched for additional literature. We included (cluster-) randomized controlled trials (RCTs) and prospective or retrospective cohort studies analyzing the relationship between hospital or surgeon volume and mortality, morbidity or quality of life. We assessed risk of bias of included studies using ROBINS-I and performed a systematic synthesis without meta-analysis and used GRADE for assessing the certainty of the evidence. RESULTS: We included 12 cohort studies on hospital volume. Higher hospital volume may reduce in-hospital mortality of neonates with gastroschisis, while the evidence is very uncertain for other outcomes. Findings are based on a low certainty of the evidence for in-hospital mortality and a very low certainty of the evidence for all other analyzed outcomes, mainly due to risk of bias and imprecision. We did not identify any study on surgeon volume. CONCLUSION: The evidence suggests that higher hospital volume reduces in-hospital mortality of newborns with gastroschisis. However, the magnitude of this effect seems to be heterogeneous and results should be interpreted with caution. There is no evidence on the relationship between surgeon volume and outcomes.

Acquisition of chromosome 1q duplication in parental and genome-edited human-induced pluripotent stem cell-derived neural stem cells results in their higher proliferation rate in vitro and in vivo.

OBJECTIVES: Genetic engineering of human-induced pluripotent stem cell-derived neural stem cells (hiPSC-NSC) may increase the risk of genomic aberrations. Therefore, we asked whether genetic modification of hiPSC-NSCs exacerbates chromosomal abnormalities that may occur during passaging and whether they may cause any functional perturbations in NSCs in vitro and in vivo. MATERIALS AND METHODS: The transgenic cassette was inserted into the AAVS1 locus, and the genetic integrity of zinc-finger nuclease (ZFN)-modified hiPSC-NSCs was assessed by the SNP-based karyotyping. The hiPSC-NSC proliferation was assessed in vitro by the EdU incorporation assay and in vivo by staining of brain slices with Ki-67 antibody at 2 and 8 weeks after transplantation of ZFN-NSCs with and without chromosomal aberration into the striatum of immunodeficient rats. RESULTS: During early passages, no chromosomal abnormalities were detected in unmodified or ZFN-modified hiPSC-NSCs. However, at higher passages both cell populations acquired duplication of the entire long arm of chromosome 1, dup(1)q. ZNF-NSCs carrying dup(1)q exhibited higher proliferation rate than karyotypically intact cells, which was partly mediated by increased expression of AKT3 located on Chr1q. Compared to karyotypically normal ZNF-NSCs, cells with dup(1)q also exhibited increased proliferation in vivo 2 weeks, but not 2 months, after transplantation. CONCLUSIONS: These results demonstrate that, independently of ZFN-editing, hiPSC-NSCs have a propensity for acquiring dup(1)q and this aberration results in increased proliferation which might compromise downstream hiPSC-NSC applications.

Relationship between volume and outcome for surgery on congenital diaphragmatic hernia: A systematic review.

BACKGROUND: Congenital diaphragmatic hernia (CDH) is a rare and life-threatening anomaly that needs surgical therapy after clinical stabilization of the neonate. Given an existing volume-outcome relationship for other high-risk, low volume procedures, we aimed at examining the relationship between hospital or surgeon volume and outcomes for surgery on CDH. METHODS: We conducted a systematic search in multiple databases in September 2019 and searched for additional literature. We assessed risk of bias of included studies using ROBINS-I and synthesized results in a structured narrative way using GRADE. RESULTS: We included 5 cohort studies on hospital volume. Results for in-hospital mortality, one-year mortality and length of stay are inconclusive. The certainty of the evidence was very low for all outcomes, due to risk of bias, inconsistency and imprecision. We did not identify any study on surgeon volume. CONCLUSION: Due to the very low certainty of the evidence it is uncertain whether higher hospital volume is associated with favorable outcomes for neonates undergoing surgery for CDH. There is no evidence on the relationship between surgeon volume and outcomes. Future studies should use more rigorous methodology and analyze additional outcomes to allow for more meaningful inferences. LEVEL OF EVIDENCE: III SYSTEMATIC REVIEW REGISTRATION: PROSPERO (CRD42018090231).

["If they were to stop coming, I'd panic" : Palliative care networks from the perspectives of patients and informal care givers]. / "Wenn die mal nicht mehr kommen würden, dann kriege ich eine Krise" : Netzwerke der ambulanten Palliativversorgung aus Sicht von Patienten und Angehörigen.

OBJECTIVE: This study examines the perspectives of patients and family caregivers on outpatient palliative care networks. It contrasts primary palliative care (AAPV) and specialized outpatient care (SAPV) services, particularly in regard to pain management. METHODS: The study is based on 27 semi-structured, problem-focussed interviews with 21 patients and 19 informal caregivers. Recruitment was based on purposive sampling in two regions of Brandenburg, Germany. The data were analysed using qualitative content analysis. RESULTS: In AAPV, the general practitioner (GP) is both the central point of contact as well as the coordinator of the care network. In SAPV, the GP plays a less important role. This can lead to conflicts between GPs and health care professionals of the palliative care team. Compared to AAPV, palliative care teams are attributed greater intervention capacities in acute situations as well as expertise in pain therapy. Thus, the option of parenteral administration of opioids is considered a benefit of specialized care. The use of nursing services varies considerably depending on the individual care network-in some cases care is completely taken over by relatives. Relatives are the closest to the patient within the care network and perform key tasks. CONCLUSION: The personal and professional composition of networks of outpatient palliative care varies individually according to care situation and form. Care networks of AAPV and SAPV differ with regard to the accessibility of health care professionals and pain therapy. Home-based palliative care is often made possible by informal care givers in the first place.

External Validation and Update of the RICP-A Multivariate Model to Predict Chronic Postoperative Pain.

Objective: The development of chronic postsurgical pain (CPSP) is influenced by several factors. The risk index for chronic pain (RICP) was developed to identify patients at high risk for CPSP. The aim of this study was the external validation and update of the RICP. Design: Prospective cohort study. Setting: Two German hospitals. Subjects: Participants who underwent orthopedic surgery, general surgery, visceral surgery, and neurosurgery. Methods: The predicted outcome was CPSP at six months. We validated the original RICP externally and performed a model update. Analysis was performed using logistic regression. We analyzed the discrimination and calibration of the model. Furthermore, the updated model was internally validated. Results: We included 205 patients. The mean age of participants was 51 years. CPSP was reported by 53.9% of participants. In our population, the original RICP (preoperative pain in the operating field, other preoperative pain, postoperative acute pain, capacity overload, and comorbid stress symptoms) showed a sensitivity of 0.708 and a specificity of 0.727 (area under the curve [AUC] = 0.766, 95% confidence interval [CI] = 0.688-0.843). The updated RICP (preoperative pain in the operating field, other preoperative pain, postoperative acute pain, sex, marital status) yielded a sensitivity of 0.746 and a specificity of 0.726 (AUC = 0.813, 95% CI = 0.740-0.886). The results were confirmed by cross-validation. Pre- and postoperative pain measures showed the highest predictive ability. Discussion: The study indicates external validity of the original RICP. The updated RICP also showed good predictive ability. The results are limited by the small sample size and the amount of missing outcome data.

First Report of Awake Craniotomy of a Famous Musician: Suprasellar Tumor Surgery of Pianist Clara Haskil in 1942.

Clara Haskil (January 7, 1895-December 7, 1960) was one of the most famous female pianists of the 20th century. In her life and work she set new standards in piano playing. However, her career was beset by poor health and the adversities of two world wars. In her lifetime Haskil had three major disorders: juvenile scoliosis requiring treatment in her adolescence, a tumor of the sellar region requiring surgery at age 47 years, and a traumatic brain injury causing her death at the age of 65. Her medical history illustrates the development of surgical methods and rehabilitation in medicine before and after World War II. At an early age, she spent a year in a nursing home for orthopedic diseases due to scoliosis. In 1942, when she was 47 years old, she displayed the first symptoms of a suprasellar brain tumor: headache and hemianopsia. The famous surgeon Marcel David performed surgery on her without general anesthesia while Haskil mentally played a Mozart piano concerto as a neuronal representation to control her memory and mental abilities. Only 3 months after that operation she played a Mozart piano concerto at a concert that began her career as a great interpreter of Mozart. Her neurologic rehabilitation was remarkable and highlighted new methods in the field. In 1960, she traveled to Brussels for a concert. In the train station she stumbled on the stairs and hit her head on one of the steps. Skull fracture and intracranial hematoma were diagnosed. Doctors tried to operate on her but she lost consciousness and died. Haskil created new styles in piano playing, and her medical history offers indications of new concepts in neurosurgery.

Randomized, controlled, two-arm, interventional, multicenter study on risk-adapted damage control orthopedic surgery of femur shaft fractures in multiple-trauma patients.

BACKGROUND: Long bone fractures, particularly of the femur, are common in multiple-trauma patients, but their optimal management has not yet been determined. Although a trend exists toward the concept of "damage control orthopedics" (DCO), current literature is inconclusive. Thus, a need exists for a more specific controlled clinical study. The primary objective of this study was to clarify whether a risk-adapted procedure for treating femoral fractures, as opposed to an early definitive treatment strategy, leads to an improved outcome (morbidity and mortality). METHODS/DESIGN: The study was designed as a randomized controlled multicenter study. Multiple-trauma patients with femur shaft fractures and a calculated probability of death of 20 to 60 % were randomized to either temporary fracture fixation with external fixation and defined secondary definitive treatment (DCO) or primary reamed nailing (early total care). The primary objective was to reduce the extent of organ failure as measured by the maximum sepsis-related organ failure assessment (SOFA) score. RESULTS: Thirty-four patients were randomized to two groups of 17 patients each. Both groups were comparable regarding sex, age, injury severity score, Glasgow Coma Scale, prothrombin time, base excess, calculated probability of death, and other physiologic variables. The maximum SOFA score was comparable (nonsignificant) between the groups. Regarding the secondary endpoints, the patients with external fixation required a significantly longer ventilation period (p = 0.049) and stayed on the intensive care significantly longer (p = 0.037), whereas the in-hospital length of stay was balanced for both groups. Unfortunately, the study had to be terminated prior to reaching the anticipated sample size because of unexpected low patient recruitment. CONCLUSIONS: Thus, the results of this randomized study reflect the ambivalence in the literature. No advantage of the damage control concept could be detected in the treatment of femur fractures in multiple-trauma patients. The necessity for scientific evaluation of this clinically relevant question remains. TRIAL REGISTRATION: Current Controlled Trials ISRCTN10321620 Date assigned: 9 February 2007.

Laparoscopic versus open appendectomy in patients with suspected appendicitis: a systematic review of meta-analyses of randomised controlled trials.

BACKGROUND: Several systematic reviews (SRs) of randomised controlled trials (RCTs) comparing laparoscopic versus open appendectomy have been published, but there has been no overview of SRs of these two interventions. This overview (review of review) aims to summarise the results of such SRs in order to provide the most up to date evidence, and to highlight discordant results. METHODS: Medline, Embase, Cinahl, the Cochrane Database of Systematic Reviews and the Database of Abstracts of Reviews of Effects were searched for SRs published up to August 2014. Study selection and quality assessment using the AMSTAR tool were carried out independently by two reviewers. We used standardised forms to extract data that were analysed descriptively. RESULTS: Nine SRs met the inclusion criteria. All were of moderate to high quality. The number of randomized controlled trials (RCTs) they included ranged from eight to 67. The duration of surgery pooled by eight reviews was 7.6 to 18.3 minutes shorter using the open approach. Pain scores on the first postoperative day were lower after laparoscopic appendectomy in two out of three reviews. The risk of abdominal abscesses was higher for laparoscopic surgery in half of six meta-analyses. The occurrence of wound infections pooled by all reviews was lower after laparoscopic appendectomy. One review showed no difference in mortality. The laparoscopic approach shortened hospital stay from 0.16 to 1.13 days in seven out of eight meta-analyses, though the strength of the evidence was affected by strong heterogeneity. CONCLUSION: Laparoscopic and open appendectomy are both safe and effective procedures for the treatment of acute appendicitis. This overview shows discordant results with respect to the magnitude of the effect but not to the direction of the effect. The evidence from this overview may prove useful for the development of clinical guidelines and protocols.

Acute and chronic wound fluids influence keratinocyte function differently.

Wound healing requires a proper functioning of keratinocytes that migrate, proliferate and lead to a competent wound closure. Impaired wound healing might be due to a disturbed keratinocyte function caused by the wound environment. Basically, chronic wound fluid (CWF) differs from acute wound fluid (AWF). The aim of this study was to analyse the effects of AWF and CWF on keratinocyte function. We therefore investigated keratinocyte migration and proliferation under the influence of AWF and CWF using MTT [3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide] test and scratch assay. We further measured the gene expression by qRT-PCR regarding growth factors and matrixmetalloproteinases (MMPs) involved in regeneration processes. AWF had a positive impact on keratinocyte proliferation over time, whereas CWF had an anti-proliferative effect. Keratinocyte migration was significantly impaired by CWF in contrast to an undisturbed wound closure under the influence of AWF. MMP-9 expression was strongly upregulated by CWF compared with AWF. Keratinocyte function was significantly impaired by CWF. An excessive induction of MMP-9 by CWF might lead to a permanent degradation of extracellular matrix and thereby prevent wounds from healing.

A risk-adapted approach is beneficial in the management of bilateral femoral shaft fractures in multiple trauma patients: an analysis based on the trauma registry of the German Trauma Society.

BACKGROUND: Today, there is a trend toward damage-control orthopedics (DCO) in the management of multiple trauma patients with long bone fractures. However, there is no widely accepted concept. A risk-adapted approach seems to result in low acute morbidity and mortality. Multiple trauma patients with bilateral femoral shaft fractures (FSFs) are considered to be more severely injured. The objective of this study was to validate the risk-adapted approach in the management of multiple trauma patients with bilateral FSF. METHODS: Data analysis is based on the trauma registry of the German Trauma Society (1993-2008, n = 42,248). Multiple trauma patients with bilateral FSF were analyzed in subgroups according to the type of primary operative strategy. Outcome parameters were mortality and major complications as (multiple) organ failure and sepsis. RESULTS: A total of 379 patients with bilateral FSF were divided into four groups as follows: (1) no operation (8.4%), (2) bilateral temporary external fixation (DCO) (50.9%), bilateral primary definitive osteosynthesis (early total care [ETC]) (25.1%), and primary definitive osteosynthesis of one FSF and DCO contralaterally (mixed) (15.6%). Compared with the ETC group, the DCO group was more severely injured. The incidence of (multiple) organ failure and mortality rates were higher in the DCO group but without significance. Adjusted for injury severity, there was no significant difference of mortality rates between DCO and ETC. Injury severity and mortality rates were significantly increased in the no-operation group. The mixed group was similar to the ETC group regarding injury severity and outcome. CONCLUSION: In Germany, both DCO and ETC are practiced in multiple trauma patients with bilateral FSF so far. The unstable or potentially unstable patient is reasonably treated with DCO. The clearly stable patient is reasonably treated with nailing. When in doubt, the patient is probably not totally stable, and the safest precaution may be to use DCO as a risk-adapted approach. LEVEL OF EVIDENCE: Therapeutic study, level IV. Epidemiologic study, level III.

Incidence of chronic postsurgical pain (CPSP) after general surgery.

OBJECTIVE: This study investigated the incidence and determinants of chronic postsurgical pain (CPSP) in a general surgical patient population. DESIGN: This is a prospective cross-sectional study at a university-affiliated clinic/level 1 trauma center. Patients were followed at least 1 year postoperatively. By surgical discipline, procedures were 50% orthopedic/trauma, 33% general (abdominal/visceral), and 17% vascular. SETTING: All patients admitted during one year (N = 3020) were eligible. Exclusion criteria were cognitive impairment, communication/language barrier, nonoperative treatment, and refusal to participate. A CPSP questionnaire was completed. Step-by-step analysis followed with a 2(nd) questionnaire to detect CPSP with numeric rating scale (NRS) pain intensity ≥3. Finally, individual follow-up examinations were performed. RESULTS: 911 patients responded (30.2%). 522 complained of pain intensity ≥3 on NRS (scale 0-10). The second step identified 214 patients with chronic pain (NRS ≥3, mean 29 months postoperatively). On final examination, 83 CPSP patients (14.8%) were identified. By surgical discipline, 28% were general, 15% vascular, and 57% trauma/orthopedic surgery. Most oftenly cited pain sites were joint (49.4%), incisional/scar (37.7%), and nerve pain (33.7%). By procedure, patients underwent pelvic surgery, colon surgery, laparoscopies, inguinal herniorrhaphies, arthroscopies, and hardware extractions. All patients in the "laborer" and "unemployed" categories reported chronic pain. CONCLUSION: Bias due to study design and/or heterogeneity of patients is possible, but there was a high CPSP rate after 2 years both generally and particularly in orthopedic/trauma (57%) patients. Both "major" and "minor" surgical procedures led to CPSP.

George Gershwin -- a case of new ways in neurosurgery as well as in the history of Western music.

George Gershwin, the famous American composer, died in 1937 of a temporal lobe glioma. An emergency surgery was performed by R. Nafziger and W. E. Dandy. The case of George Gershwin indicates the beginning of a new era in music history as well as in the history of neurosurgery.

[Requirements for quality indicators. The relevance of current developments in outcomes research for quality management]. / Anforderungsprofil an Qualitätsindikatoren. Relevanz aktueller Entwicklungen der Outcomes Forschung für das Qualitätsmanagement.

The assessment of the health state in patients and changes in their health state for the purpose of diagnosis, prognosis and monitoring of treatment response plays a central role in clinical practice. Quality criteria for measurements in medicine include validity, reliability, responsiveness, interpretability, and feasibility. High-quality measurement instruments are a prerequisite for evidence-based medicine. Therefore, international outcomes research groups have developed methods for quality assurance and for the standardisation of measurement instruments. Quality indicators are instruments to measure the quality of care. Due to the increasing relevance of quality assessment for all stakeholders in healthcare and due to the political intention to draw relevant conclusions from the assessment of the quality of care, quality indicators must at least meet the same high standards that are required for clinical trial end points. However, independent researchers and clinicians do not engage in the validation and standardisation of quality indicators in Germany; currently, only the AQUA institute (as assigned by the German GBA) deals with this important issue. Current activities concerning the validation of quality indicators do not meet the requirements of evidence-based healthcare. This is a critical barrier to achieving the political goals of quality medicine. Therefore, the authors propose a multi-step, multi-professional, evidence-driven and evidence-generating consensus process on the basis of established methods of outcomes research for the advancement of quality assessment with quality indicators in Germany. All relevant stakeholders should participate in this process.

Treatment of subcutaneous abdominal wound healing impairment after surgery without fascial dehiscence by vacuum assisted closure™ (SAWHI-V.A.C.®-study) versus standard conventional wound therapy: study protocol for a randomized controlled trial.

BACKGROUND: A decision of the Federal Joint Committee Germany in 2008 stated that negative pressure wound therapy is not accepted as a standard therapy for full reimbursement by the health insurance companies in Germany. This decision is based on the final report of the Institute for Quality and Efficiency in Health Care in 2006, which demonstrated through systematic reviews and meta-analysis of previous study projects, that an insufficient state of evidence regarding the use of negative pressure wound therapy for the treatment of acute and chronic wounds exists. Further studies were therefore indicated. METHODS/DESIGN: The study is designed as a multinational, multicenter, prospective randomized controlled, adaptive design, clinical superiority trial, with blinded photographic analysis of the primary endpoint. Efficacy and effectiveness of negative pressure wound therapy for wounds in both medical sectors (in- and outpatient care) will be evaluated. The trial compares the treatment outcome of the application of a technical medical device which is based on the principle of negative pressure wound therapy (intervention group) and standard conventional wound therapy (control group) in the treatment of subcutaneous abdominal wounds after surgery. The aim of the SAWHI-VAC® study is to compare the clinical, safety and economic results of both treatment arms. DISCUSSION: The study project is designed and conducted with the aim of providing solid evidence regarding the efficacy of negative pressure wound therapy. Study results will be provided until the end of 2014 to contribute to the final decision of the Federal Joint Committee Germany regarding the general admission of negative pressure wound therapy as a standard of performance within both medical sectors. TRIAL REGISTRATION: Clinical Trials.gov NCT01528033German Clinical Trials Register DRKS00000648.

[On the attractiveness, implementation and evaluation of guidelines]. / Leitlinien - Attraktivität, Implementierung und Evaluation.

Principles and conditions for guideline implementation and evaluation were the subject of a workshop organised by the German Association of the Scientific Medical Societies (AWMF) and the German Network for Health Services Research (DNVF). This report reflects contents and discussions and suggests possible future activities. The workshop highlighted the need for conceptual frameworks, theory-driven research and concerted strategies. The reinforcement of strategic partnerships within the health care organisations is an indispensable prerequisite for successful guideline implementation and evaluation.(As supplied by author).

The treatment of patients with severe and multiple traumatic injuries.

BACKGROUND: The care of severely and multiply injured patients is an interdisciplinary challenge. The only existing German-language guideline up to now has been the S1-guideline issued in 2002 by the German Society for Trauma Surgery (Deutsche Gesellschaft für Unfallchirurgie, DGU). In this article, we present a new, comprehensive, evidence and consensus based S3-guideline for the treatment of severely and multiply injured patients in the pre-hospital and early in-hospital phases which has been developed with the aim of structural and procedural quality optimization. Its implementation should lower these patients' mortality and improve their quality of life. METHODS: The guideline was developed by a panel consisting of 18 delegates from 11 specialty societies under the lead of the DGU, with designated coordinators for each of three phases of treatment: the pre-hospital phase, the emergency-room phase, and the emergency surgery phase. The key questions to be answered were determined by vote, and then the relevant literature (in English and German, 1995-2010) was systematically searched and evaluated. Key recommendations with explanatory texts were formulated and agreed upon in a nominal group process (NGP) with five consensus conferences and three further Delphi rounds. RESULTS: 264 recommendations were issued: 66 for the pre-hospital phase, 102 for the emergency-room phase, and 96 for the emergency surgery phase. The three phases were subcategorized according to organizational and anatomical considerations. Topics of major emphasis were, in the pre-hospital phase, the establishment and implementation of correct priorities for treatment; in the emergency-room phase, the creation of clear structures and processes; and, in the emergency surgery phase, the avoidance of secondary injury (i.e., the principle of damage control). CONCLUSION: This guideline can only improve outcomes if it is implemented in routine practice. Aside from the guideline itself, the DGU trauma network (www.dgu-traumanetzwerk.de) has issued a set of directions as an aid to its implementation.

EAES recommendations on methodology of innovation management in endoscopic surgery.

BACKGROUND: Under the mandate of the European Association for Endoscopic Surgery (EAES) a guideline on methodology of innovation management in endoscopic surgery has been developed. The primary focus of this guideline is patient safety, efficacy, and effectiveness. METHODS: An international expert panel was invited to develop recommendations for the assessment and introduction of surgical innovations. A consensus development conference (CDC) took place in May 2009 using the method of a nominal group process (NGP). The recommendations were presented at the annual EAES congress in Prague, Czech Republic, on June 18th, 2009 for discussion and further input. After further Delphi processes between the experts, the final recommendations were agreed upon. RESULTS: The development and implementation of innovations in surgery are addressed in five sections: (1) definition of an innovation, (2) preclinical and (3) clinical scientific development, (4) scientific approval, and (5) implementation along with monitoring. Within the present guideline each of the sections and several steps are defined, and several recommendations based on available evidence have been agreed within each category. A comprehensive workflow of the different steps is given in an algorithm. In addition, issues of health technology assessment (HTA) serving to estimate efficiency followed by ethical directives are given. CONCLUSIONS: Innovations into clinical practice should be introduced with the highest possible grade of safety for the patient (nil nocere: do no harm). The recommendations can contribute to the attainment of this objective without preventing future promising diagnostic and therapeutic innovations in the field of surgery and allied techniques.

Protocol for a randomized controlled trial on risk adapted damage control orthopedic surgery of femur shaft fractures in multiple trauma patients.

BACKGROUND: Fractures of the long bones and femur fractures in particular are common in multiple trauma patients, but the optimal management of femur fractures in these patients is not yet resolved. Although there is a trend towards the concept of "Damage Control Orthopedics" (DCO) in the management of multiple trauma patients with long bone fractures as reflected by a significant increase in primary external fixation of femur fractures, current literature is insufficient. Thus, in the era of "evidence-based medicine", there is the need for a more specific, clarifying trial. METHODS/DESIGN: The trial is designed as a randomized controlled open-label multicenter study. Multiple trauma patients with femur shaft fractures and a calculated probability of death between 20 and 60% will be randomized to either temporary fracture fixation with fixateur externe and defined secondary definitive treatment (DCO) or primary reamed nailing (early total care). The primary objective is to reduce the extent of organ failure as measured by the maximum sepsis-related organ failure assessment (SOFA) score. DISCUSSION: The Damage Control Study is the first to evaluate the risk adapted damage control orthopedic surgery concept of femur shaft fractures in multiple trauma patients in a randomized controlled design. The trial investigates the differences in clinical outcome of two currently accepted different ways of treating multiple trauma patients with femoral shaft fractures. This study will help to answer the question whether the "early total care" or the "damage control" concept is associated with better outcome. TRIAL REGISTRATION: Current Controlled Trials ISRCTN10321620.

Psychosocial predictors and correlates for chronic post-surgical pain (CPSP) - a systematic review.

Chronic post-surgical pain (CPSP) is a serious problem. Incidence as high as 50% has been reported, depending on type of surgery undergone. Because the etiology of chronic pain is grounded in the bio-psychosocial model, physical, psychological, and social factors are implicated in the development of CPSP. Biomedical factors such as pre-operative pain, severe acute post-operative pain, modes of anesthesia, and surgical approaches have been extensively examined, therefore this systematic review focuses on psychosocial elements. A systematic search was performed using the PubMed, PsychINFO, Embase, and Cochrane Databases. Fifty relevant publications were selected from this search, in which psychosocial predictors for and correlates to CPSP were identified. The level of evidence was assessed for each study, and corresponding score points were awarded for ease of comparison. The grade of association with CPSP for each predictor/correlate was then determined. Depression, psychological vulnerability, stress, and late return to work showed likely correlation with CPSP (grade of association=1). Other factors were determined to have either unlikely (grade of association=3) or inconclusive (grade of association=2) correlations. In addition, results were examined in light of the type of surgery undergone. This review is intended as a first step to develop an instrument for identifying patients at high risk for CPSP, to optimize clinical pain management.