Integrin ß1 polymorphisms and bleeding risk after coronary artery stenting.

Bleeding complications following percutaneous coronary intervention associate with increased mortality. However, the underlying molecular mechanisms are insufficiently understood. Platelet recruitment and activation at sites of vascular injury depends on the function of integrin adhesion receptors. Besides GPIIbIIIa as the most abundant integrin receptor, platelets relevantly express ß1 integrins. Experimental evidence from in vivo studies suggests a significant role of ß1 integrins in primary haemostasis. However, little is known about the clinical impact of genetic alterations of the ß1 subunit, which might contribute to bleeding complications in patients. In this study, we performed DNA sequencing of patients suffering from bleeding complications after coronary artery stenting according to TIMI or BARC classification. We isolated DNA samples from 741 patients out of a cohort from 14,160 patients recruited in seven randomized clinical trials between June 2000 and May 2011. Subsequently, Sanger sequencing was performed covering the ß1 integrin cytoplasmic activation domain (exon16) and its non-coding upstream region. Out of 764 patients suffering from bleeding complications, 741 DNA samples were successfully sequenced. Genotype variation was detected for SNP rs2153875 located within the non-coding upstream region with following allele frequency in study population: CC (7.3%), CA (35%) and AA (57.8%), which is similar to a general population cohort. Further, genotype variation in SNP rs2153875 do not associate with the frequency of TIMI or BARC classified access or non-access site bleedings. Genotype variations of the ß1 integrin activation domain do not associate with bleeding risk after PCI.

[Identification of Control Hospitals for the Implementation of the Nationwide and Standardized Evaluation of Model Projects According to § 64b SGB V: Analysis of Data from Structured Quality Reports]. / Auswahl geeigneter Kontrollkliniken für die Durchführung der bundesweiten und einheitlichen Evaluation von Modellvorhaben nach § 64b SGB V. Analyse von Daten der Strukturierten Qualitätsberichte.

BACKGROUND: Health care needs of mentally ill patients make special demands on cross-sectoral health care structures. § 64b SGB V enables care of mentally ill patients through model projects that are multi-professional, work across treatment periods and sectors and implement new forms of financing. These model projects in their hospitals (case hospitals) need to be evaluated and compared with standard treatment methods. OBJECTIVES: The aim of this analysis is to identify matching hospitals according to a priori defined criteria for the establishment of a control group (control hospitals) using secondary data. MATERIALS AND METHODS: A systematic analysis was conducted based on structured quality reports according to §+137 SGB V and matched data from the Federal Institute for Research on Building, Urban Affairs and Spatial Development (BBSR). Based on a priori defined knock-out criteria, criteria based on patients (weighting 50%), structural features of hospitals (25%) and environmental factors (25%), a weighted similarity score was calculated for each of the 13 case hospitals, which could reach the maximum of 100 points (perfect match). RESULTS: 10 control hospitals per case hospital were identified according to the weighted similarity score. The median of the total deviation of potential control hospitals from the case hospitals was 34.3 (range: 17.6-66.7). The median of the 10 selected control hospitals per case hospital was 30.9 (range: 17.6-40.8). DISCUSSION: The defined algorithm could be used to identify similar control hospitals. The method using the mentioned databases and derivation of specific criteria of structural similarity are generally suitable in controlled designs for the evaluation of complex interventions based on routine data.

[Utilization of Physical Therapy Services in Germany from 2004 until 2014: Analysis of Statutory Health Insurance Data]. / Physiotherapeutische Versorgungssituation in Deutschland von 2004 bis 2014. Analyse des Verordnungsverhaltens bei Versicherten der Gesetzlichen Krankenversicherung.

Background: Both at the national and international levels, direct access for patients to physical therapy services is currently under debate. Direct access for patients seeking physical therapy care might reduce waiting time and costs, and thus be of benefit for patients and health insurance companies. To critically evaluate this situation, reliable and valid data are needed, but currently lacking. The aim of this study is to evaluate the health care situation for physical therapy services included in the catalogue of remedies from 2004 up to 2014 in Germany. Methods: To obtain information regarding physical therapy services included in the catalogue of remedies, the freely available "Heilmittel-Informations-System (GKV-HIS)" was used. Data from the regional Associations of Statutory Health Insurance Physicians as well as data from federal reports were extracted for the years from 2004 up to 2014. Results: Prescription of physical therapy increased continuously from 2004 and 2014. In 2004, 155 677 860 and in 2014, 254 695 514 physical therapies were prescribed (increase of 61%). The highest number of physical therapies was prescribed in Saxony for all years, whereas in North Rhine-Westphalia and Hessen the lowest number per 1 000 GKV insured persons. Gross sales from physical therapy services differed between federal states and were the highest in Saxony (2004: 59.8; 2009: 54.6, 2014: 76.7) and Baden-Wuerttemberg (2004: 60.0; 2009: 57.6; 2014: 68.0). Discussion: The results of this study show utilization of physical therapy services as defined in the catalogue of remedies in Germany to be heterogeneous. However, causal relationship cannot be identified on the basis of the analyzed data highlighting the need for further research. Criteria for structural-, process- and outcome-quality are needed to be able to evaluate the quality of physical therapy services. To ensure the quality of physical therapy services, interprofessional and patient relevant research is needed.

A Consensus German Reporting Standard for Secondary Data Analyses, Version 2 (STROSA-STandardisierte BerichtsROutine für SekundärdatenAnalysen).

Although secondary data analyses have been established in recent years in health research, explicit recommendations for standardized, transparent and complete reporting of secondary data analyses do not exist as yet. Therefore, between 2009 and 2014, a first proposal for a specific reporting standard for secondary data analysis was developed (STROSA 1). Parallel to this national process in Germany, an international reporting standard for routine data analysis was initiated in 2013 (RECORD). Nevertheless, because of the specific characteristics of the German health care system as well as specific data protection requirements, the need for a specific German reporting standard for secondary data analyses became evident. Therefore, STROSA was revised and tested by a task force of 15 experts from the working group Collection and Use of Secondary Data (AGENS) of the German Society for Social Medicine and Prevention (DGSMP) and the German Society for Epidemiology (DGEpi) as well as from the working group Validation and Linkage of Secondary Data of the German Network for Health Services Research (DNVF). The consensus STROSA-2 checklist includes 27 criteria, which should be met in the reporting of secondary data analysis from Germany. The criteria have been illustrated and clarified with specific explanations and examples of good practice. The STROSA reporting standard aims at stimulating a wider scientific discussion on the practicability and completeness of the checklist. After further discussions and possibly resulting modifications, STROSA shall be implemented as a reporting standard for secondary data analyses from Germany. This will guarantee standardized and complete information on secondary data analyses enabling assessment of their internal and external validity.

Requirements and Application Guide for the Use of Quality Indicators in Medical Care: Results of a Systematic Review.

Background: Quality indicators are employed in the assessment of quality of medical care. Valid measurement and reporting of quality are essential for maintenance and enhancement of high-quality medical care. The aim of this study was to identify the requirements for quality indicators and their successful implementation in routine care. Method: A systematic literature search conducted in Medline using MESH keywords resulted in 573 hits. A complementary hand search additionally identified 153 papers, so that in all 726 abstracts were screened. In conformity with the PRISMA Statement, 83 papers were finally included in this review. Results: Quality criteria are described in 48 publications and requirements for the application of quality indicators in medical care are given in 41 publications. Validity (n=19), feasibility (n=16), reliability (n=15), and interpretability of the quality indicator (n=14) are the most frequently named quality criteria, followed by relevance (n=10), sensitivity (n=8) and risk adjustment (n=6). The most common requirements for the application of quality indicators are integration of quality indicators in the given healthcare setting (n=15) and ability to derive potential improvement (n=11), data validity (n=8), data availability (n=7) as well as acceptance of the measurement in the given setting (n=6). Conclusion: Plausible quality measurements help improve healthcare structures and processes and provide patients and professionals with valid statements on the quality of care. The original articles examined focus primarily on the validity of quality indicators. A consensus on methodological criteria for the development, implementation and application of quality indicators is required. Furthermore, the practical applicability of quality criteria should be tested empirically.

[Orthopaedic and trauma surgical care until 2050. Analysis of the utilization behavior for relevant diseases and derivation of the number of medical service providers]. / Orthopädisch-unfallchirurgische Versorgung bis 2050. Analyse des Inanspruchnahmeverhaltens bei relevanten Erkrankungen und Ableitung der Häufigkeit ärztlicher Leistungserbringer.

BACKGROUND: Due to current and prospective demographic developments, the provision of high-quality medical care is not guaranteed in Germany. OBJECTIVES: The aim of this study is to analyze the utilization of medical service providers for diseases related to orthopedic/trauma surgery and deduce the corresponding number of medical service providers until 2050. MATERIALS AND METHODS: Data provided by the Statistical Offices of the Federal Republic and the Federal States and the Scientific Institute of the AOK (2008-2012) were used to analyze the utilization behavior of four pre-determined orthopedic/trauma surgery disease groups (osteoarthritis, back pain, osteoporosis, trauma). Routine data of the current (2012) health care provision delivered by the compulsory health insurances (GKV) are the basis of the prognosis. Using population projections from the Federal Statistical Office, the health care demand until 2050 was predicted and using statistics from the German Medical Association, the number of required health care providers was determined. RESULTS: An increase in physician consultations until 2040 is expected for osteoarthritis (+ 21 %), osteoporosis (26 %), and trauma (+ 13 %). From 2040-2050 the health care utilization behavior of all examined diseases is expected to decrease. The increasing health care usage behavior until 2040 is associated with an increase in health care providers. CONCLUSIONS: Until 2030 a significant increase in the burden of orthopedic/trauma surgery diseases is expected. In 2050 the level of health care needs will be equivalent to that in 2030. Comprehensive needs assessment and planning are needed in order to create health care provision structures and processes that address potential changes in utilization behavior.

[Prioritization and Consentation of Criteria for the Appraisal, Funding and Evaluation of Projects from the German Innovationsfonds: A multi-perspective Delphi study]. / Priorisierung und Konsentierung von Begutachtungs-, Förder- und Evaluationskriterien für Projekte aus dem Innovationsfonds: Eine multiperspektivische Delphi-Studie.

BACKGROUND: The German Innovationsfonds provides the chance for evidence-based developments of the German healthcare system. OBJECTIVE: Prioritization of recommendations for an effective, efficient, fair, transparent, and sustainable granting of funds through a transparent, evidence-driven consensus-process involving all relevant stakeholder groups. METHODS: Representatives from health and research policy, payers, patient representatives, healthcare providers, and scientists were invited to nominate participants for an electronic 3 round iterative Delphi-study to prioritize the thematic focus, requirements concerning study methods, the team of applicants, evaluation, utilization of study results, and for the selection of reviewers. Criteria considered as relevant by at least 60% of the panel (consensus definition) in the first 2 Delphi rounds were rated as facultative, preferable, or obligatory criteria for project funding. Data were analyzed descriptively. ( REGISTRATION: Datenbank Versorgungsforschung Deutschland VfD_15_003561). RESULTS: All invited stakeholder groups except payers participated. 34 (85%) of 40 nominated representatives participated in the Delphi-study. A total of 64 criteria were consented as relevant for project review and funding concerning the thematic focus (n=28), methodological requirements (n=13), requirements for applicants (n=4), for the evaluation (n=4), utilization (n=6), and selection of peer reviewers (n=9). DISCUSSION: It is the collective responsibility of all stakeholders to spend the designated funds as efficient and sustainable as possible. The consented recommendations shall serve decision makers as a resource for the granting of funds and the evaluation of the Innovationsfonds.

[Recommendations for quality indicators in German S3 guidelines: a critical appraisal]. / Empfehlungen zur Messung der Versorgungsqualität in aktuellen S3-Leitlinien: Eine kritische Bestandsaufnahme.

BACKGROUND: Assessment of the quality of medical care plays an increasingly important role in the German healthcare system. Requirements for quality indicators include validity, reliability, responsiveness, interpretability and feasibility. Because of the high impact of guidelines, quality indicators that are recommended in such guidelines are of special relevance. METHODS: We conducted a systematic review of all German S3 guidelines (actual as of November 30(th), 2013) to investigate the proportion of guidelines recommending quality indicators, which categories to classify quality indicators were used, and whether quality indicators in German S3 guidelines were developed following evidence-based methods. RESULTS: In 34 from 87 S3 guidelines (39%) a total of 394 quality indicators were defined. The vast majority of the recommended quality indicators focused on process quality. Outcome indicators were only recommended in 9 S3 guidelines (10%). None of the guidelines analysed reported the properties of the recommended quality indicators. CONCLUSION: Despite the increasing relevance of quality assessment for all stakeholders in the German healthcare system only approximately 40% of the S3 guidelines define indicators to measure the quality of care. Recommendations to assess outcome indicators are only provided in 10% of S3 guidelines. The process of the development and recommendation of quality indicators is heterogeneous and frequently not transparently reported. The current practice for the recommendation and validation of quality indicators in German S3 guidelines does not meet the requirements of evidence-based healthcare.

Which factors predict incident pressure ulcers in hospitalized patients? A prospective cohort study.

BACKGROUND: The prevention of pressure ulcers (PU) is an important public health issue owing to their substantial clinical and economic burden. OBJECTIVES: To investigate predictors of incident PU in hospitalized patients and the performance of the Braden Scale in intensive care units (ICU) and normal care units (NCU). METHODS: We conducted a prospective cohort study including all inpatients treated at the University Hospital Carl Gustav Carus Dresden, Germany, between 2007 and 2011. Documentation comprised patient characteristics, Braden Scale and clinical signs of PU. The primary outcome was incident PU during inpatient treatment. Predictors of PU were explored by using univariate and multivariate logistic regression models. To evaluate the performance of the Braden Scale a receiver operating characteristics (ROC) curve analysis was applied. RESULTS: The overall incidence of PU during inpatient treatment was 0·78%. A higher rate of PU was observed at ICU vs. NCU (4·77% vs. 0·59%). Multivariate analysis identified age [odds ratio (OR) 1·04, 95% confidence interval (CI) 1·035-1·041 per year], female sex (OR 1·11, 95% CI 1·01-1·22), length of stay (OR 17·79, 95% CI 15·46-20·48 for 30 or more days vs. < 10 days) and admission from care facility compared with admission from home (OR 3·14, 95% CI 2·63-3·75) as significant predictors of incident PU. The area under the ROC curve was 84·89% at NCU and 69·0% at ICU. CONCLUSIONS: The identified predictors for incident PU may inform targeted, evidence-driven preventive measures to decrease the burden of PU.

Gene expression profiles in the acutely dissected human aorta.

OBJECTIVES: heritable connective tissue abnormalities and arterial hypertension may predispose to aortic dissection. This study evaluates gene expression profiles in the acutely dissected human aorta. DESIGN, MATERIALS AND METHODS: Atlas Human Broad Arrays I, II, and III (Clontech) were used to compare gene expression in acutely dissected (6 patients) and normal ascending aortas (6 multiorgan donors). The tissues were also compared macroscopically. RESULTS: of 3537 genes analysed, 1250 (35%) were expressed in aortic tissue. For statistical analysis we focused on 627 genes, which had an intensity>0.95 of the mean patients or controls. Dissected and adjacent macroscopically intact aorta displayed similar gene expression patterns. On the contrary, 66 genes were expressed significantly different in dissected aorta, compared with undiseased control aorta of multiorgan donors. Genes, predominantly upregulated in dissection, are involved in inflammation, in extracellular matrix proteolysis, in proliferation, translation and transcription. Predominantly downregulated genes code for extracellular matrix proteins, adhesion proteins and cytoskeleton proteins. CONCLUSION: our results demonstrate for the first time the complexity of the dissecting process on a molecular level. The ultimate dissection seems to be the dramatic endpoint of a long-lasting process of degradation and insufficient remodelling of the aortic wall. Altered patterns of gene expression suggest a pre-existing structural failure of the aortic wall, resulting in dissection.

Heart-type fatty acid binding protein (hFABP) in the diagnosis of myocardial damage in coronary artery bypass grafting.

OBJECTIVES: Heart-type fatty acid binding protein (hFABP) is an intracellular molecule engaged in the transport of fatty acids through myocardial cytoplasm and has been used as a rapid marker of myocardial infarction. However, its value in the evaluation of perioperative myocardial injury has not yet been assessed. METHODS: 32 consecutive patients undergoing coronary artery bypass grafting were included in a prospective, randomized study using standardized operative procedures and myocardial protection. Three patients with perioperative myocardial infarction were added. Serial blood samples were taken preoperatively, before ischemia, 5 and 60 min after declamping, 1 and 6 h postoperatively and on postoperative days 1, 2 and 10 and were tested for hFABP, creatine kinase isoenzyme MB (CKMB) and troponin I (TnI). RESULTS: Hospital mortality was zero. The kinetics of the biochemical parameters revealed a typical pattern for each marker. In routine patients, hFABP levels peaked as early as 1 h after declamping, whereas CKMB and TnI peaked only 1 h after arrival in the intensive care unit. Patients with perioperative infarction displayed peak levels some hours later in all marker proteins. Peak serum levels of hFABP correlated significantly with peak levels of CKMB (r=0.436, P=0.011) and TnI (r=0.548, P=0.001), indicating the degree of myocardial damage. CONCLUSIONS: hFABP is a rapid marker of perioperative myocardial damage and peaks earlier than CKMB or TnI. The kinetics of marker proteins in serial samples immediately after reperfusion is more suitable for the detection of perioperative myocardial infarction than a fixed cut-off level.

Does the time of resternotomy for bleeding have any influence on the incidence of sternal infections, septic courses or further complications?

BACKGROUND: Former studies on sternal wound infections indicate predisposing factors like diabetes, obesity, use of bilateral internal mammary grafts, impaired renal function and reoperation. We wanted to evaluate whether the time of resternotomy for postoperative bleeding has any influence on the development of a sternal wound infection and other complications. METHODS: In our department, 12,315 patients underwent median sternotomy for cardiac surgery between 1987 and 1998. We analyzed the clinical data of all patients which were reoperated on for postoperative bleeding, especially patients with subsequent operations caused by sternal wound infections. All data were compared by T-test respectively chi2-test, and p<0.05 was regarded as significant. RESULTS: 406 of the 12,315 patients were re-explored because of postoperative bleeding (3.3%). 57 (14%) of these patients died in the postoperative period of non-infectious complications. The remaining patients were divided into two groups: Group A (286 patients) (70.4%) did not suffer from any sternal wound complications, where as group B patients (n = 63) (15.6%) needed subsequent surgery due to sternal infection. There were no significant differences in either concerning age, clinical data and first operation. All patients had an average blood loss of 223 ml/hr. The time before re-operation for bleeding was 5.3+/-1.7 hours in group A compared to 11.1+/-4.2 hours in group B (p<0.05). A significant delay of reoperation for bleeding could also be found for patients with postoperative septic complications (ø: 5.2+/-1.9 hours, +: 12.9+/-5.2 hours), renal failure, mechanical ventilation >48 hours and a stay in hospital >20 days. CONCLUSIONS: Early reoperation for postoperative bleeding decreases the number of subsequent complications, e.g. sternal wound infections, septic complications and prolonged mechanical ventilation.

T-cell-mediated rejection of vascularized xenografts in the absence of induced anti-donor antibody response.

T cells are considered to play a major indirect role in the pathogenesis of xenograft vascular rejection, by promoting the induction of anti-donor antibodies that trigger complement- and antibody-dependent cell cytotoxicity. However, how vigorous the T cell xenoresponse is in vivo, and whether, besides their helper function, T cells are capable of directly affecting the graft is still unclear. We have previously shown that cyclosporine A (CsA) withdrawal in accommodated cardiac xenograft recipient allows for a rapid and dense T-cell infiltration, concomitant to an acute graft rejection. In this paper we further characterize the role of T cells in this rejection process and we demonstrate that adoptive transfer of CD4+ T cells in irradiated recipients of long-term cardiac xenografts is sufficient to trigger acute rejection, in the absence of any detectable induced anti-hamster antibody response. Therefore, our data suggest that unusually strong T-cell response will be another major barrier to xenotransplantation, even if antibody-mediated vascular rejection is controlled.

Procalcitonin (PCT) in cardiac surgery: diagnostic value in systemic inflammatory response syndrome (SIRS), sepsis and after heart transplantation (HTX).

PURPOSE: Since it is of great importance to distinguish between a systemic inflammatory response syndrome (SIRS) and an infection caused by microbes especially after heart transplantation (HTX), we examined patients following heart surgery by determining procalcitonin (PCT), because PCT is said to be secreted only in patients with microbial infections. METHODS: Sixty patients undergoing coronary artery bypass grafting (CABG) and 14 patients after heart transplantation were included in this prospective study. In the CABG group we had 30 patients without any postoperative complications (group A). Furthermore we took samples of 30 patients who suffered postoperatively from a sepsis (group B, n=15) or a systemic inflammatory response syndrome (C, n=15). In addition we measured the PCT-levels in 65 blood samples of 14 patients after heart transplantation (Group I: rejection > IIa, II: viral infection (CMV), III: bacterial/fungal infection, IV: controls). RESULTS: In all patients of group A the pre- and intraoperative PCT-values and the measurement at arrival on intensive care unit (ICU) were less than 0.2 ng/ml. On the second postoperative day the PCT-value was 0.33+/-0.15 ng/ml in the control group. At the same time it was 19.6+/-6.2 ng/ml in sepsis and 0.7+/-0.4 ng/ml in systemic inflammatory response syndrome patients (P<0.05). In transplanted patients we could find the following PCT-values: Gr.I: 0.18+/-0.06 II: 0.30+/-0.09 III: 1.63+/-1.16 IV: 0.21+/-0.09 ng/ml (P<0.05 comparing group III with I, II and IV). CONCLUSIONS: These results show that extracorporeal circulation (ECC) and systemic inflammatory response syndrome do not initiate a PCT-secretion. Septic conditions cause a significant increase of PCT. In addition, PCT is a reliable indicator concerning the essential differentiation of bacterial or fungal--not viral--infection and rejection after heart transplantation.

Effects of modification of the allocation system on ischemia duration and costs of heart transplantation. Transplantation Cooperation UNI-NRW.

BACKGROUND: In order to optimize regional utilization of transplantable thoracic organs, the seven university hospitals in North-Rhine-Westfalia have formed a transplant cooperation meanwhile approved by Eurotransplant. METHODS: Heart transplant and organ donation activities of the cooperating hospitals in the year before the foundation of the cooperation (period A, 7/95 - 6/96) and in the year thereafter (period B, 7/96 - 6/97) were retrospectively analysed. RESULTS: In period A, a total of 39 heart transplants and 74 heart donations were performed, whereas in period B 67 heart transplantations and 78 heart donations could be achieved. The regional utilization of the donor organs increased from 4% to 30% with a significantly shorter ischemia time of regionally or locally allocated donor hearts than of nationally or internationally allocated ones. CONCLUSIONS: A high rate of regional or local heart transplant procedures with short ischemia times clearly demonstrate the benefits of a regionalization of heart transplant medicine for medical as well as economical reasons.

Hyperbaric oxygen therapy in deep sternal wound infection after heart transplantation.

The results of orthotopic heart transplantation (OHTx) are still burdened with considerable early mortality due to graft rejection or infection. Sternum osteomyelitis is an infrequent postoperative complication. We report a case of deep sternal wound infection (2 months after OHTx) that was treated with hyperbaric oxygen therapy in addition to local surgical treatment.

Beta-adrenoceptor inhibition for induction of acute cardiac failure in pigs.

For the testing of heart assist devices most animal models of acute cardiac failure that are usually used show certain disadvantages. We therefore developed a new method using the beta-adrenoceptor antagonist carazolol. We administered a bolus injection of 1 mg/kg followed by a continuous infusion of 1 mg/kg/h in adult German 'Landrasse' pigs. Blood pressure, heart rate, cardiac output and maximum left ventricular pressure rise time showed a significant (P < 0.05) reduction of the control value varying between 40% and 59%. The method is suitable for the testing of surgical approaches in heart failure.

[Ischemic cardiomyopathy--transplantation and bridging with mechanical assist systems]. / Ischämische Kardiomyopathie--Transplantation und Uberbrückung mittels mechanischen Assistenzsystemen.

The number of patients with ischemic cardiomyopathy and accompanying chronic pump failure of the left and/or right ventricle has tripled within the last 10 years. Ischemic cardiomyopathy represents numerically the greatest share as the reason for illness in heart transplantation today; their results are not different for patients following cardiac transplantation due to primary cardiomyopathy. Since heart transplantation has become a clinical routine method today, the discrepancy between the number of the available donor organs and the number of the needed organs becomes more and more obvious. The longer waiting lists and the longer waiting times are responsible for the increased use of bridging systems. Today the long-term results after heart transplantation are not worse in patients after bridging. With more experience in the field of mechanical support, better devices, and proved indications, frequent improvement of prerequisites for transplantation can be achieved in this group of patients. The implantable ventricles give the patient the change of full mobilization and, therefore, high clinical acceptance of this management can be registered.