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Wilfried Lorenz

Publications and source records attributed to Wilfried Lorenz.

At least 19 recordsLinked to original sources
PubMed2006

[The German program for disease management guidelines. Background, methods, and development process].

The Program for National Disease Management Guidelines (German DM-CPG Program) was established in 2002 by the German Medical Association (umbrella organization of the German Chambers of Physicians) and joined by the Association of the Scientific Medical Societies (AWMF; umbrella organization of more than 150 professional societies) and by the National Association of Statutory Health Insurance Physicians (NASHIP) in 2003. The program provides a conceptual basis for disease management, focusing on high-priority health-care topics and aiming at the implementation of best practice recommendations for prevention, acute care, rehabilitation and chronic care. It is organized by the German Agency for Quality in Medicine, a founding member of the Guidelines International Network (G-I-N). The main objective of the German DM-CPG Program is to establish consensus of the medical professions on evidence-based key recommendations covering all sectors of health-care provision and facilitating the coordination of care for the individual patient through time and across interfaces. Within the last year, DM-CPGs have been published for asthma, chronic obstructive pulmonary disease, type 2 diabetes, and coronary heart disease. In addition, experts from national patient self-help groups have been developing patient guidance based upon the recommendations for health-care providers. The article describes background, methods, and tools of the DM-CPG Program, and is the first of a publication series dealing with innovative recommendations and aspects of the program.

Disease Management↗
PubMed2006

Early self-reported impairments in arm functioning of primary breast cancer patients predict late side effects of axillary lymph node dissection: results from a population-based cohort study.

OBJECTIVES: Improvements in the life expectancy of women with breast cancer raise important questions how to improve quality of life (QoL) for women sustaining complications and side effects of cancer treatment. The presented study examined the prevalence of arm morbidity in a cohort of primary breast cancer patients over time as a result of the extent of axillary lymph node dissection. Of particular interest is the question of using a recognized QoL assessment instrument at defined assessment points as an endpoint criteria of oncological treatment. METHODS: A prospective, population-based, longitudinal cohort study of patients with primary breast cancer was performed (n = 389). QoL data (EORTC QLQ C30 + BR23) and clinical data were assessed at designated time points. Primary endpoint of this analysis was patient reported arm morbidity assessed with the three-idem scale in the BR 23 (swelling, moving, pain). RESULTS: 20% of the patients evidenced considerable impairments in arm functioning. Arm morbidity was significantly related to the number of lymph nodes dissected (P < 0.002 entire cohort, P < 0.001 lymph node negatives) and was independent of age, stage of the disease, kind of breast surgery and radiation treatment. Early impairments in arm functioning (below 50 score values) assessed within 6 months after axillary surgery was a good predictor for late arm morbidity at 12 months RR 11.5 (CI 95% 4.7-28.4), 24 months RR 6.0 (CI95% 2.8-13.3) and 36 months RR 3.8 (CI 95% 1.8-7.9). CONCLUSIONS: Arm morbidity after axillary surgery is a severe and chronic condition affecting many breast cancer patients. The recognized QoL assessment instrument depict patients with severe impairments in arm functioning after axillary lymph node dissection and predict late arm morbidity. To increase patients' quality of life it thus may serve as a valid assessment tool for screening, allowing early referral for treatment and monitoring.

Aged↗
PubMed2006

Evaluation of the McPeek postoperative outcome score in three trials.

BACKGROUND: Postoperative outcome of patients is determined by recovery characteristics and self-reported quality of life. The first can be assessed with the McPeek score which values three aspects of recovery: mortality, postoperative critical care and duration of hospitalization. MATERIALS AND METHODS: We calculated the McPeek score of 669 patients in three trials: (1) colorectal cancer surgery, (2) antihistamine/volume loading in various operations, and (3) cholecystectomy. Beforehand, the average of intensive care unit treatment and duration of hospitalization were determined for the different operations to define McPeek score points. The score was tested on reliability, validity, and sensitivity. In addition, clinical applicability was assessed in a survey. RESULTS: The score was reliable with similarly distributed score points in the three trials at different institutions. Inter-rater reliability was high (97% overlap). Validity was proven by moderate high correlation to convergent criteria such as complications (trial I to III r=0.43, r=0.38, r=0.60), preoperative American Society of Anesthesiologists class (ASA) (r=0.24, r=0.28, r=0.57), and age (r=0.23, r=0.32, r=0.31). The score was different between patients with and without neoplasms (P<0.001, trial II) and between elective or emergency patients (P<0.001, trial III). In a survey, investigators reported that the score was easy to assess and more comprehensive than four other scores. CONCLUSIONS: The McPeek score values the postoperative outcome on a nonlinear scale. A priori, the average duration of hospitalization and critical care for a specific operation has to be defined. Our validation suggests that it is a reliable, valid, sensitive, and practical instrument for outcome analysis after anesthesia and surgery.

Adult↗
PubMed2006

Granulocyte colony-stimulating factor prophylaxis improves survival and inflammation in a two-hit model of hemorrhage and sepsis.

OBJECTIVE: We evaluated the effects of a granulocyte-colony stimulating factor (G-CSF) prophylaxis in two clinically relevant situations, hemorrhage on the day before infection (e.g., trauma) and acute hemorrhage followed subsequently by infection (e.g., operative complication). A two-hit model of hemorrhage and polymicrobial peritoneal contamination and infection (PCI) was used to assess the influence of G-CSF on the outcome, bacterial clearance, and cytokine pattern. DESIGN: Clinic modeling randomized laboratory trial. SETTING: University laboratory. SUBJECTS: One hundred thirty-two male rats. INTERVENTIONS: In trial 1 we compared a) preoperative PCI only; b) preoperative hemorrhage plus PCI; and c) hemorrhage plus PCI plus G-CSF prophylaxis (n=18 rats/group). In trial 2, intraoperative hemorrhage was assessed with the same trial design. Primary end point was survival at 120 hrs. In trial 2 additionally, six rats per group and six naive control rats were used for secondary end point analysis. MEASUREMENTS AND MAIN RESULTS: Primary end point was mortality at 120 hrs. Secondary end points were granulocyte counts, bacterial clearance, and local cytokine levels. In trial 1 survival rate was 56% after PCI only, 17% after hemorrhage plus PCI, and 61% after hemorrhage plus PCI plus G-CSF (p<.01). In trial 2 survival rate was 33% after PCI only, 17% after hemorrhage plus PCI, and 50% after hemorrhage plus PCI plus G-CSF (p<.05). In trial 2, neutrophil counts were doubled to 66% 1 hr after hemorrhage (p<.05), colony-forming units of microbes in the lung and liver were halved to 166+/-56 and 134+/-28 colony-forming units (p<.05 for liver), and the macrophage inflammatory protein-2 expression in the lung was halved to 0.88+/-0.06 pg of complementary DNA (p<.05) by G-CSF prophylaxis compared with hemorrhage and PCI. CONCLUSIONS: Hemorrhage (first hit) sensitized the host for a second hit of polymicrobial PCI independent of the timing. G-CSF prophylaxis improved survival and clearance of microbes and reduced the proinflammatory chemokine macrophage inflammatory protein-2 in the lung.

Animals↗
PubMed2006

[Diagnosis and therapy of illness-related quality of life in breast cancer patients. Protocol of a randomized clinical trial at the Regensburg Tumour Centre].

BACKGROUND: The project conducted at the Tumour Centre in Regensburg aims to integrate quality of life (QL) diagnostics with the therapy of breast cancer patients and to evaluate the efficacy of QL diagnostics in the context of a randomized clinical trial. METHODS: The Regensburg Tumour Centre provides the infrastructure of the present project (telemedicine, project groups, quality circle). The treatment of breast cancer patients is based on the recent national breast cancer therapy guideline, including assorted QL-enhancing therapy options such as pain therapy, physiotherapy and lymphatic drainage, psychotherapy, social counselling and rehabilitation, nutrition and sports. During an implementation phase a new method of QL diagnostics has been developed. Five experts with varying professional background use the individual patient's QL profile and clinical and socio-demographic information in order to generate a QL report including a treatment recommendation. The study is designed as a two- arm randomized clinical trial with one test group (communication of the QL findings to the co-ordinating physician) and a control group (no communication). Patients with newly diagnosed breast cancer who are treated in the study region by one of the co-ordinating doctors will be included in this randomized study. At designated points in time QL assessments (EORTC QLQ-C30 plus BR23) will be conducted over a 12-months period. EXPECTED RESULTS: We expect that patients in the test group will experience a lower amount of QL deficits at the end of the study period (M = 1, SD = 2) than patients in the control group (M = 2, SD = 2). The statistical confirmation of this expected effect requires a total sample size of N = 200 (n = 100 vs. n = 100, alpha = 5% [two-tailed], beta = 10%). CONCLUSIONS: This is the first study to evaluate a new form of QL diagnostics in the complexity of a real patient care environment, and it promises to make the inclusion of the quality of life concept into the current breast cancer treatment guideline more tangible.

Breast Neoplasms↗
PubMed2004

Integrated outcome assessment after anterior cervical discectomy and fusion: myelocompression but not adjacent instability affect patient-reported quality of life and cervical spine symptoms.

STUDY DESIGN: The authors conducted a cross-sectional study. OBJECTIVE: Integrated assessment of adjacent instability (AI), myelocompression (MC), magnetic resonance imaging (MRI) signs of myelopathy (MRISM), physician-assessed clinical signs and symptoms, including clinical signs of myelopathy (CSM), patients' self-reported symptoms and quality of life after anterior cervical discectomy and fusion (ACDF). MATERIALS AND METHODS: Fifty-four patients who had ACDF between 1986 and 1995 received MRI scans, conventional and flexion/extension radiographs to assess myelocompression, MRISM, fusion, and AI. Clinical outcome was assessed using signs and symptoms based on selected items of Odom's criteria, Oswestry low back pain disability questionnaire, and the neck disability index. Patients reported their quality of life (QL) on a standardized instrument (Profiles of QL of Chronically Ill [PLC]) and by a specific validated Cervical Spine Symptom Scale (CSSS). RESULTS: Myelocompression was found more frequently than expected (24%). MRISM were seen in 2 patients (4%). One of the 2 patients developed CSM. Fusion was achieved in 94% (with kyphosis in 17%). AI was found in 30%. However, only myelocompression but not AI was associated with statistically significant decreases in most QL scores (i.e., everyday capabilities, positive mood) and high cervical spine symptom burden (all P's < 0.05). CONCLUSIONS: The study results underline the need for a better understanding of the biomechanical changes in the adjacent unfused segments. Consensus is needed on postoperative follow-up guidelines, including pain management strategies. Future studies on the outcome of ACDF will profit from an integrated outcome approach, including assessments based on imaging, physicians, and patients.

Adult↗
PubMed2004

Dependence of positive effects of granulocyte colony-stimulating factor on the antibiotic regimen: evaluation in rats with polymicrobial peritonitis.

We tested the hypothesis that the ability of granulocyte colony-stimulating factor (G-CSF) to prevent death from fecal peritonitis is influenced by the composition of the antibiotic regimen with which it is administered. We used a rodent model of polymicrobial peritoneal contamination and infection and the concept of clinical modeling randomized trials (CMRTs), which includes the conditions of randomized, clinical trials and complex clinical interventions (e.g., anesthesia, volume substitution, antibiotics, surgery, postoperative analgesia). With the peritonitis model we obtained a mortality dose-response curve that was sensitive to antibiotic prophylaxis. G-CSF was most efficacious when it was administered both prophylactically and after the onset of peritonitis. Cefuroxime/metronidazole, ofloxacin/metronidazole, and amoxicillin/clavulanate improved survival in combination with G-CSF best, whereas cefotaxime or ceftriaxone with and without metronidazole did not. G-CSF administration was associated with improved polymorphonuclear neutrophil phagocytosis and enhanced bacterial clearance. Pro-inflammatory cytokine release (tumor necrosis factor-a, interleukin-6, macrophage inflammatory protein-2) was decreased in plasma and in the peritoneal fluid. Their expression was lowered in various organs on the protein and mRNA level. The results were used to design a clinical trial to test the ability of G-CSF to prevent serious infections in patients with colorectal cancer surgery. In this trial G-CSF application and antibiotic prophylaxis were performed with the most effective scheduling and combinations (cefuroxime/metronidazole and ofloxacin/metronidazole) as defined here.

Animals↗
PubMed2004

Mild preseptic hypothermia is detrimental in rats.

OBJECTIVE: We evaluated the effects of mild hypothermia (32 degrees C), established before experimental intra-abdominal sepsis, on outcome, cytokine pattern, and muscle tissue oxygenation. DESIGN: Clinic modeling randomized laboratory trial. SETTING: University laboratory. SUBJECTS: Ninety-six male rats. INTERVENTIONS: In a group-sequential design, using 42 rats per group, we compared mild hypothermia with normothermia before peritonitis. Peritoneal inoculation with human stool bacteria was performed to simulate clinical trial conditions. Additionally, 12 rats underwent preoperative mild hypothermia without infection. MEASUREMENTS AND MAIN RESULTS: Primary end point was mortality at 120 hrs. Secondary end points were systemic cytokine concentrations, granulocyte counts, and muscle oxygen partial pressure. Survival rate was 40% (16 of 42) after preseptic hypothermia and 62% (26 of 42) after preseptic normothermia (p =.048). All hypothermic rats without infection survived. Interleukin-10 concentrations were 1843 +/- 96 pg/mL after preseptic hypothermia, 945 +/- 225 pg/mL with preseptic normothermia, and 520 +/- 121 pg/mL after hypothermia without infection (p<.001). Macrophage inflammatory protein-2 was comparable in the treatment groups. Interleukin-6 concentrations were 106 +/- 24 pg/mL after preseptic hypothermia and 276 +/- 76 pg/mL with preseptic normothermia (p<.05). Postinfection granulocyte count was 1.7 x 10(9)/L after hypothermia and 2.4 x 10(9)/L after normothermia (p =.2). After infection, muscle oxygen partial pressure was 47 +/- 10 mm Hg with preseptic hypothermia, 85 +/- 12 mm Hg in preseptic normothermia, and 49 +/- 9 mm Hg after hypothermia without infection (p =.7). CONCLUSIONS: In this rat model of intra-abdominal sepsis, mild preseptic hypothermia (32 degrees C) reduced survival, impaired granulocyte recruitment, and changed cytokine balance, suggesting immunosuppression.

Animals↗
PubMed2004

[A concept for the implementation and evaluation of the guideline "Early Detection of Breast Cancer in Germany"].

Systematically developed, evidence- and consensus-based guidelines are important tools for improving health care services. The effectiveness of a guideline does not only relate to its methodological quality but also to the implementation strategy used. The following paper describes the systematic development of a strategy for implementing and evaluating the guideline "Early Detection of Breast Cancer in Germany" as part of a national project. A multi-faceted systematic implementation strategy has been developed addressing existing barriers and building on projects that have recently been introduced in Germany to improve the early detection and management of breast cancer. The aim is to induce behavioural changes in women as healthcare recipients and physicians as healthcare providers, both involved in the medical decision-making process within the scope of the guideline. Furthermore, it supports organisational changes to assure compliance with the guideline by means of quality assurance and quality management. To ensure evaluation of the implementation process a set of quality indicators have been identified for the baseline assessment of structures, provider performance and outcomes. Both the effectiveness of the implementation process and the effectiveness of the guideline itself will be measured by using the same set of indicators for reevaluation within a pre-defined time interval of 18 months. The quasi-experimental design of this uncontrolled before and after implementation study outlined in the present paper allows the assessment of clinically relevant changes using quality indicators that measure the effectiveness of the guideline on a national level.

Breast Neoplasms↗
PubMed2004

[Short version of the guideline "Early Detection of Breast Cancer in Germany"].

The aim of this evidence-, consensus- and outcome-based good clinical practice guideline is to help physicians, and women in making appropriate healthcare decisions about the early detection of breast cancer. The principle of early detection of breast cancer comprises the detection and diagnosis of pre-malignant breast tumours (UICC stage 0, carcinoma in situ) with a possible cancer risk reduction and the detection and diagnosis of breast cancer at an early stage (UICC stage 1) with a scientifically proven 90% chance of cure. By establishing a nation-wide comprehensive quality assurance program for the early detection of breast cancer this guideline lays the foundation for a timely reduction of breast cancer mortality and achievement of cure with less impairment of patient's quality of life. It would appear that this guideline makes major improvements in women's healthcare feasible.

Algorithms↗
PubMed2003

Deleterious effects of mild hypothermia in septic rats are ameliorated by granulocyte colony-stimulating factor.

BACKGROUND: The authors studied the effects of mild hypothermia on the outcome in a rat model of intraabdominal sepsis and tested whether granulocyte colony-stimulating factor (G-CSF) augments the host response and improves outcome during mild hypothermia. METHODS: A rat model of peritoneal contamination and infection with human stool bacteria was used to simulate clinical trials that included increasing complexity. In trial 1, postoperative hypothermia (32 degrees C) was compared with normothermia (38 degrees C), without supportive treatment (10 rats per group). In trial 2, with a more severe infection, rats were given antibiotic prophylaxis. Using 20 rats per group, the authors compared postoperative hypothermia (32 degrees C), normothermia, and postoperative hypothermia (32 degrees C) with 20 mug/kg G-CSF prophylaxis given 12 h before surgery and 12 h and 36 h after surgery. The primary endpoint was death at 120 h. Secondary endpoints were systemic cytokine concentrations, leukocyte counts, and the phagocytic activity of granulocytes and monocytes. RESULTS: In trial 1, 50% of the normothermia group and 10% of the postoperative hypothermia group survived. In trial 2, 50% of the normothermia group, 20% of the hypothermia group, and 60% of the hypothermia plus G-CSF group survived. Postoperative hypothermia plus G-CSF reduced plasma concentrations of interleukin-6 (hypothermia group, 511 +/- 104 pg/ml; hypothermia plus G-CSF group, 247 +/- 51 pg/ml) and macrophage inflammatory protein-2 (hypothermia group, 239 +/- 43 pg/ml; hypothermia plus G-CSF group, 178 +/- 21 pg/ml). CONCLUSIONS: In this rat model of intraabdominal sepsis, postoperative hypothermia was deleterious. However, G-CSF treatment, initiated before contamination, reduced the mortality rate, increased the neutrophil count, and downgraded the systemic cytokine response.

Animals↗
PubMed2003

From clinical evidence to everyday practice: implementing findings from a cost-effectiveness analysis for endoscopic injection therapy for upper-gastrointestinal bleeding.

BACKGROUND: A previous upper-gastrointestinal bleeding trial showed that patients treated with repeated fibrin glue injection for upper-gastrointestinal bleeding have significantly less rebleeding than those treated with polidocanol. OBJECTIVE: To analyse the cost and effectiveness of repeated fibrin glue injection and to investigate whether these results change physicians' attitudes. DESIGN: A retrospective random sample of five hospitals from the previous study, collection of cost identification, and follow-up data on 320 patients (155 in the polidocanol group, 165 in the fibrin glue group). METHODS: An incremental cost-effectiveness analysis and comparison of outcomes was performed using chi-squared tests and Kaplan-Meier survival analysis. A survey was carried out using a questionnaire in the five hospitals on local guidelines for management of ulcer bleeding, and its results were analysed qualitatively. The measure of effectiveness is the number of prevented rebleedings. Further variables were length of hospital stay and length of intensive care unit (ICU) stay. RESULTS: The cost for the prevention of one additional rebleeding by repeated fibrin glue treatment amounts to 14,316 +/- 4981 euros (incremental cost-effectiveness ratio). There were no significant differences in length of stays in ICU or in hospital. The physicians did not change their management plans for patients with upper-gastrointestinal bleeding. In a survey, it was seen that other factors, such as local guidelines, attitudes towards new treatment options, and ease of handling of drugs, are more important than a result of a single study for a behavioural change of the doctors. CONCLUSIONS: The study was not designed prospectively to address a pharmacoeconomic question. As relevant variables (e.g. length of ICU stay) could not be reliably ascertained retrospectively, this may lead to biased estimates of the incremental cost-effectiveness ratio.

Cost-Benefit Analysis↗
PubMed2003

The genetic background of hypertensive, septic rats determines outcome improvement with antibiotic and G-CSF prophylaxis.

Hypertension is proposed as a risk factor among others (high age, diabetes mellitus, and pre- and intraoperative bleeding) for adverse outcomes, such as severe infections, leading to sepsis and to multiple organ failure as the most deleterious complication. Hypertension was modeled with spontaneous hypertensive rats (SHR) and Dahl salt-sensitive (DS) rats and the infective complication by polymicrobial, peritoneal contamination, and infection (PCI). The concept of clinic modeling randomized trials was used to simulate clinical complexity, including a relevant antibiotic prophylaxis in combination with granulocyte-colony stimulating factor (G-CSF) and clinical trial conditions. Outcome parameters were: survival, systemic cytokines (protein), and organ-specific cytokine levels (mRNA). With low complexity (no prophylaxis), 28% of the animals in the Wistar and 50% in the SHR group survived (P=0.17). Tumor necrosis factor-alpha levels were lower in the liver of SHR vs. Wistar rats with PCI (P<0.01). The anti-inflammatory cytokine interleukin (IL)-10 was expressed on a higher level in SHR with PCI compared with Wistar rats (P<0.01). With increased complexity (antibiotic and G-CSF prophylaxis) the survival rate was increased from 50% in Wistar rats to 89% in SHR (P<0.01) and the mRNA expression of IL-6 was decreased in the kidney of SHR (P<0.05). Survival rate was 44% in the DS rats vs. 67% of the Wistar rats (P=0.18). The mRNA expression of tumor necrosis factor-alpha and IL-10 was reduced (P<0.01) by pretreatment in the liver of DS rats with PCI. The hypertensive, genetically distinct SHR and DS rats express different patterns of pro- and anti-inflammatory cytokine levels after PCI. G-CSF and antibiotic prophylaxis increases only in SHR survival and decreases IL-6 mRNA expression in the kidney significantly.

Animals↗
PubMed2003

Relation between severe illness and non-completion of quality-of-life questionnaires by patients with rectal cancer.

Quality of life (QoL) is an important outcome measure in clinical studies, but interpretation is hindered by incompleteness of data. We addressed this issue in a population-based cohort study of 146 patients with newly diagnosed rectal cancer. QoL was assessed by means of European Organization for the Research and Treatment of Cancer questionnaires at discharge from hospital after primary treatment and then every 3 months for 2 years. In parallel, objective clinical data were documented. Analyses were conducted in three steps: participants versus non-participants with QoL-assessment; poor compliers who filled in only one or two questionnaires (n=20) versus good compliers who filled in all or nearly all questionnaires (n=18); and the proportion of missing forms and critical (very poor) QoL scores in risk patients versus non-risk patients over the course of 2 years. Non-participants and poor compliers were older, were more likely to receive palliative (rather than curative) treatment, and had worse scores for physical status. Tumour progression and therapeutic interventions were more frequent in poor compliers than in good-compliers. Patients with risk factors (age 475 years, poor physical status, palliative treatment) were more likely to have missing questionnaires and critical QoL scores in respect of physical functioning and global quality of life over the course of 2 years. Missing values for QoL have clinical as well as methodological implications, because QoL scores can enhance a clinician's insight. Unwillingness to fill in a questionnaire is an indicator of serious illness. Studies that report sample statistics without specifying compliance rates and the characteristics of non-compliers will give a misleadingly positive picture.

Adult↗