[10-year development of spine surgery in Germany - An analysis of health insurance funds data from 2005 to 2014]. / 10-Jahres-Entwicklung operativer Eingriffe an der Wirbelsäule in Deutschland.

BACKGROUND: Analysis of the regional development of spine surgery in Germany between 2005 and 2014. MATERIAL AND METHODS: A secondary data analysis of inpatient data from the Scientific Institute of the AOK (WIdO) was carried out for the period 2005 to 2014. The number of spinal procedures was determined on the basis of 14 defined intervention groups (procedures according to OPS codes). The regional numbers of spine surgery procedures in the 402 districts in Germany and the regional age- and gender-standardised distribution are displayed as healthcare utilisation charts. RESULTS: 796,870 AOK-insured individuals received inpatient spinal surgery during the observation period. The relative increase in the 10-year period was 82%, with 51,053 interventions in 2005 and 91,971 interventions in 2014. The increase in spine surgery cases occurred mainly between 2005 and 2011. An increase in the number of operations was observed in all intervention groups except "excision of intervertebral discs and bones". It was different in different spinal procedures, with the greatest increases in "bone decompression" (280% increase). Regional differences were found in all intervention groups. In 2014, the number of interventions varied between 109 and 729 interventions per 100,000 AOK-insured individuals in the districts. CONCLUSION: The significant increases of more than 80% in 10 years cannot be explained solely by sociodemographic changes. The pronounced regional differences alone do not allow firm conclusions on the existence of regional underuse, overuse or misuse. The results, however, emphasise the need for further health services research on the quality of the medical indication and the determinants of regional variation.

Implementation and first results of a tablet-based assessment referring to patient-reported outcomes in an inpatient cancer care unit.

BACKGROUND: Inclusion of patient-reported outcomes (PROs) in routine cancer care is of key importance for individualized treatment, shared decision making and patient satisfaction. OBJECTIVE: To describe the implementation under routine conditions of an electronic self-administered PRO assessment and comparison of PROs before and after inpatient treatment in oncologic care. METHODS: In a tablet-based survey PROs on symptom burden, global health status/ quality of life (QoL) and health utility were collected twice (at hospital admission and discharge) in an inpatient oncological setting over a 17-month period using the EORTC QLQ-C30 and EQ-5D questionnaires. Data were linked to the hospital information system (HIS). Patient acceptability, recruitment rates, symptom burden, and clinically meaningful changes in PROs over time were analyzed. RESULTS: From a total of 384 hospitalized patients invited to participate at admission 371 (96.6 %) participated. At discharge, 195 patients were approached for a follow-up assessment, and 192 patients (98.5 %) participated. Despite strong acceptance among patients, recruitment rates were decreasing over time. During the hospital stay clinically meaningful improvements were observed for health utility (33.3 %, n = 64) and global health status/QoL (43.2 %, n = 83). Patients reported a variety of symptoms at admission and discharge. CONCLUSIONS: Implementation of PRO assessment in routine care and data integration into the HIS provides valuable information for the entire medical staff as symptom burden is present during the entire hospital stay. IMPLICATIONS FOR PRACTICE: Long-term maintenance of PRO assessment in a clinical setting as a prerequisite of value-based healthcare requires continuous involvement of the nursing team, which can only be achieved by allocating resources to this task.

Implementation of a mobile inpatient quality of life (QoL) assessment for oncology nursing.

PURPOSE: Cancer patients suffer from a variety of symptoms, but little is known about changes during hospitalization and symptom burden at discharge. We implemented an electronic quality of life (QoL) assessment used by the nursing team in routine inpatient care. Feasibility, acceptance, and the course of QoL were investigated. METHODS: A self-administered electronic questionnaire based on the EQ-5D and the EORTC QLQ-C30 was applied in clinical routine. Cancer patients were approached by the nursing staff to complete the QoL assessment twice, at admission and at the day of discharge. Both the feedback of the nursing staff as well as characteristics of participants were used to evaluate the electronic assessment. RESULTS: Out of 210 patients from an oncologic ward, 85 patients (40 %) were invited to participate, 95 % of whom (n = 81) agreed to participate. Participation rate depended on the day of admission, the presence of the coordinating nurse, the overall morbidity assessed by patient clinical complexity level, and the patient age. Forty-six patients (56 %) asked for assistance in completing the questionnaire. Patients older than 53 years and male patients were more likely to need assistance. Twenty-two percent of the nursing staff (n = 5) use the information assessed for individual patient care. Fifty-two percent (n = 12) rated the additional workload as very little or little and 68 % (n = 15) agreed that handling for the patient was easy. Global QoL improved during the stay. Most severe symptoms at admission included fatigue, pain, appetite loss, and insomnia. CONCLUSIONS: The results of this study indicate that it is feasible to implement and use an electronic QoL assessment by the nursing staff in routine inpatient cancer care. Obstacles and worries of staff members have to be considered when further developing this program.

[Five years of peer reviewing in the Quality Medicine Initiative]. / 5 Jahre Peer Review Verfahren bei der Initiative Qualitätsmedizin (IQ(M)).

OBJECTIVE: Peer review focuses on critical self-reflection, especially of physicians in direct contact and dialogue with other disciplines and professional groups. The main purpose of the peer review is the principle of self-determination, the intention to learn from each other more effectively, and a commitment to quality improvement. During the past five years the Quality in Medicine Initiative (IQM) has successfully promotes peer reviewing in German-speaking areas. The aim of this study is to investigate all records of IQM peer reviews and to outline the results in the course of development. The major focuses include medical aspects for improvement, information concerning organizational processes and the satisfaction of the visited hospitals. METHOD: A systematic descriptive analysis of all records as well as feedback sheets was conducted between 2010 and 2014. RESULTS: 294 of 304 planned peer reviews were considered, involving among different hospital owners and different clinical conditions. The identified potential for improvement of the peer team was higher than that of the physicians of the hospitals visited. The assessment of the medical review criteria illustrates the following different trends: a positive development occurred concerning the appropriate and timely diagnostic and treatment; a clear potential for improvement could be established concerning a complete and conclusive documentation. Regarding the clinical conditions, anomalies were identified which are important for all IQM hospitals. As regards sustainability, first results from so-called re-reviews were available and provided important information pointing in the direction of structure and process improvement. The satisfaction of the visited physicians increased continuously within these five years. CONCLUSION: In the light of all data records and satisfaction sheets, the IQM peer review has become well-established over the last five years. Possible reasons are a well-defined framework, clear structures and different kinds of support. The success of the cooperation of the German Medical Association and IQM is illustrated by the development of the curriculum peer review. Re-reviews provide impulses for sustainability. At any rate, there is a need for scientific evaluation of the peer review method in order to generate evidence for this important tool of quality improvement.

[Indication for total knee arthroplasty: evidence mapping]. / Indikation zur endoprothetischen Versorgung des Kniegelenks - ein Evidence Mapping.

BACKGROUND: Joint replacement surgery is one of the most often performed routine procedures for the treatment of knee osteoarthritis in Germany. Currently, there is no consensus on indication criteria for total knee arthroplasty (TKA). OBJECTIVES: The topic indication for TKA was processed using six guiding questions concerning: 1) Common practice in determining the indication for TKA; 2) Inclusion criteria in clinical trials; 3) Treatment goals/goal criteria; 4) Predictors for goal attainment; 5) Economic aspects of determining a TKA indication; 6) Guidelines of the "Working Group of Scientific Medical Societies" (AWMF) in other areas. METHODS: The evidence mapping was conducted by systematically searching Medline via Ovid, the Cochrane Library, through hand searching national guidelines and selected journals as well as the AWMF guideline portal. RESULTS OF THE GUIDING QUESTIONS: 1) In Germany there is currently no consented guideline regarding indications for TKA surgery. 2) Indication criteria for clinical trials are: diagnosed osteoarthritis of the knee, limitations of age and BMI. The most common criteria for exclusion include rheumatoid/inflammatory arthritis, secondary diagnoses and allergies. 3) As yet, no international initiatives have been identified which, by involving all relevant stakeholders, have reached consensus regarding the indication criteria for TKA. 4) A variety of predictors were identified with effects on individual treatment goals acting in different directions. 5) Very few studies were identified concerning economic aspects of determining TKA indication. 6) Comparable AWMF guidelines are currently not available. CONCLUSION: The findings of this study suggest that specific systematic reviews are needed to explore the following questions: What are the treatment goals of a TKA intervention? For whom are these relevant? And how are they measured? Continuous analyses are recommended in the field of predictors for a positive TKA outcome.

[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.

[Evaluation of external quality assurance in accordance with sect. 137 SGB V at the Carl Gustav Carus university hospital in Dresden]. / Evaluation der Externen Qualitätssicherung gemäß § 137 SGB V am Universitätsklinikum Carl Gustav Carus Dresden.

BACKGROUND: Obligatory external quality assurance is an established method used to ensure the quality of inpatient care in Germany. The comprehensive approach is unique in international comparison. In addition to the statutory requirement, the health insurance funds require this form of external quality control in order to foster quality-based competition between hospitals. Ever since its introduction, healthcare providers have scrutinised the effects of the mandatory use of this survey. METHOD AND MATERIALS: The study was based on all patients in the University Hospital Dresden, for whom a quality assurance sheet (n = 45,639) had to be recorded between 2003 and 2011. The documentation of these sheets was carried out by specially trained personnel. For each performance area, the duration of the documentation quality sheets was assessed, and a descriptive analysis of all quality assurance sheets was conducted. In the presence of statistical significance the so-called "Structured Dialogues" were analysed. RESULTS: Over the whole period, 167 statistically noticeable problems occurred. Nine of these have been rated as noticeable problems in medical quality by the specialised working groups of the project office quality assurance (PGSQS) at the Saxon State Medical Association (SLÄK). The remaining 158 statistical anomalies included 25 documentation errors; 96 were classified as statistically significant, and only 37 were marked to indicate that re-observation by the PGSQS was required. The total effort estimate for the documentation of quality assurance sheets was approximately 1,420 working days in the observation period. DISCUSSION: As far as the quality of patient care is concerned, the results can be considered positive because only a small number of quality indicators indicate noticeable qualitative problems. This statement is based primarily on the comparison of the groups of Saxony and Germany, which are included in the quality report of external quality assurance in accordance with sect. 137 SGB V. The majority of noticeable statistical problems were due to documentation errors. Other noticeable statistical problems that are medically indicated, but without effect on the extramural care to patients, recurrently occur with the respective quality indicators. Examples include the postoperative mobility indicators of the implementation of endoprostheses which cannot be used to draw conclusions about patient outcomes. Information on the quality of life as well as the post-hospital course of disease would be important in this context, but is still lacking. The use of external quality assurance data in accordance with sect. 137 SGB V for evaluation research has so far been handled quite restrictively. Thus, in-depth analyses on the quality of treatment cannot be derived.

The effect of mitoxantrone on anti-pig immunization in baboons.

Besides virological and physiological concerns, the success of xenotransplantation (Xt) is still dependent on the prevention of delayed xenograft rejection (DXR). Although multifactorial, DXR is mainly due to xenonatural antibody (Ab) recognizing their xenogenic antigen (Ag) followed by complement activation. Despite the use of intensive treatments capable of inhibiting the humoral response, DXR can still not be avoided and always occurs within weeks following transplantation. Moreover, these latter treatments currently used in Xt could not be used clinically in humans because of their high risk of over-immunosuppressing the patients. Mitoxantrone (Mx) is a drug well known for its antiproliferative properties and is used clinically in oncology and in the treatment of relapsing multiple sclerosis. In models of arthritis in rats, it has been shown to be 10 to 20 times more powerful than cyclophosphamide (CyP) at blocking both inflammatory and B-cell responses. Because of its B-cell inhibitory capacity and considering the implication of the humoral response in xenograft rejection, we have compared Mx with CyP for its ability to block in vivo anti-pig immunization induced via subcutaneous injections of pig red blood cells into baboons. Neither drug was able to inhibit the anti-pig responses following the first and second immunizations, emphasizing the particularity of preformed Ab responses. However, the rise in Ab in the Mx treated animals was significantly delayed as compared with the non-treated as well as the CyP treated animals and was mainly because of a profound depletion of circulating B-cells. Mx displays an interesting antihumoral effect that we now intend to test in a pig kidney to baboon Xt model, with anticipated administration of the drug allowing an early B-cell depletion.

Tolerance induction in rats, using a combination of anti-CD154 and donor splenocytes, given once on the day of transplantation.

BACKGROUND: Donor-specific tolerance induction remains an attractive objective that generates much research in the field of transplantation. Unfortunately, most of the protocols available involve pregraft conditioning, making these treatments incompatible with clinical applications. METHODS: LEW.1A rats were grafted with histoincompatible LEW.1W hearts. On the day of transplantation, recipients were treated with anti-CD40L combined with donor splenocytes. The hearts were evaluated for graft survival; cellular infiltrate and intragraft cytokines were determined using real-time reverse transcriptase-polymerase chain reaction. Tolerance induction was assessed by skin grafting and adoptive transfers. RESULTS: The combination of a single injection of anti-CD40L and donor splenocytes, given on the day of surgery, allowed 40% of cardiac allografts to survive long-term (mean survival time=66.3 day). The cellular composition or the extent of graft infiltrate was not modified but was associated with a massive decrease of proinflammatory cytokines expression within the graft. Long-term survivors accepted donor-matched skin grafts, and leukocytes harvested from these animals transferred tolerance into irradiated freshly grafted recipients. CONCLUSION: A combination of costimulation blockade and donor cells, given once at the time of transplantation, is sufficient to induce allograft tolerance in rats.