[Health services research : Definition, objective, method and perspectives]. / Versorgungsforschung : Definition, Gegenstand, Methodik und Perspektiven.

This overview article highlights the central role of health services research (HSR) for the further development of the healthcare system. As a young scientific discipline in Germany, HSR covers five important elements with different weighting in different definitions, which are elaborated in some detail in this article: patient orientation, results and outcome orientation at the patient and population levels, implementation perspectives and context relation, complex interventions and improvement, multidisciplinarity and multiprofessionalism. One of the fundamental pillars of HRS is related to the insufficient implementation of scientifically proven treatment methods and improvement strategies into routine patient care. Healthcare research is therefore the so-called second translation of clinical trials in the routine daily care (from bedside to practice) after the first translation from bench to bedside. The scientific methods used in HSR clearly extend beyond the spectrum of (clinical) epidemiology. The methodological standards are developed as consensus memoranda of members of the German network of HSR, which serve as orientation points for qualitatively good HSR. Finally, various perspectives for the long-term safeguarding and improvement of the quality of HSR in Germany are proposed.

[What can and cannot be achieved by registries : Perspective of the registry working group of the German Network of Health Services Research]. / Was Register leisten können und was nicht : Sicht der AG Register des Deutschen Netzwerks Versorgungsforschung e. V. (DNVF).

In addition to clinical trials, registries and cohort studies are the fundamental basis of patient-orientated research. The importance of registries is increasing because more questions involving patient care under routine conditions (real world data) need to be answered. This article supplies answers to the questions: what can be achieved with registries and what are the limitations? Starting with a consensus definition of a registry from the German Network of Health Services Research (DNVF), the question of existing registries was examined and it was concluded that there was a lack of transparency. Consequently, a registry of registries similar to clinical trials registries is urgently needed as well as an evaluation of the quality of existing registries. Criteria are deduced that allow an assessment of the quality of a registry and which comprehensive possibilities registries can provide are discussed in eight different areas of interest to clinicians. The limitations of registries compared to randomized clinical trials and cohort studies are emphasized and discussed in this article. In the future, the use of registry-based randomized clinical trials (RRCT) will allow data related to efficacy as well as to effectiveness to be collated.

Felix Mendelssohn-Bartholdy and Fanny Hensel: two cases of intracerebral hemorrage and great composers of the nineteenth century.

The composer Felix Mendelssohn-Bartholdy and his sister, Fanny Hensel, both died in 1847 of intracerebral hemorrhage. Also their father and grandfather had died of cerebral strokes. Their cases show the dramatic progress of an arteriovenous malformation in the nineteenth century, but also the development of new romantic styles in the history of western music. Since the late nineteenth and the early twentieth century, neurology and neurosurgery had developed as highly specialized medical subjects. Today, neurosurgery is a highly developed medical subject, and the neurosurgeon uses high-tech equipment for neurosurgical procedures and intensive care. But before the 1960s, when modern neurosurgery began with the invention of the surgical microscope and other techniques, neurosurgical and neurological treatments were only helpless attempts with an experimental character to help a patient with a fatal disease. In the middle of the nineteenth century, symptoms of strokes or brain tumors were know, but medical knowledge and equipment were lacking. The cases of the Mendelssohn family are an interesting review of early neurology and the cultural life of the nineteenth century.

[A registry of registries and cohorts: recommendations for metadata and policies]. / Ein Register für Register und Kohorten: Empfehlungen zu Metadaten und Verfahrensregeln.

Registries and cohort studies play a central role in patient-oriented medical research, in particular in health services research. In order to increase the transparency about ongoing registries and cohort studies in Germany, and to promote communication and cooperation between the drivers in the field a so-called register portal should be established. Metadata are characteristics that are used to describe registries and cohort studies in the register portal. A limited set of characteristics, the core set, should correctly describe the projects on the one hand while reducing workload for data capture and data administration on the other hand. The core set consists of 26 data elements that had been defined in a Delphi-consensus process involving experts from the working group registries of the German Network for Health Services Research (DNVF) and the working group IT infrastructure and quality management of the Technology, Methods, and Infrastructure for Networked Medical Research (TMF). Transparent policies are required to guarantee traceability and reliability of the portal's services. Six so-called top-level-tasks and 37 use cases were defined in an interim report so far. The metadata have been agreed upon by most of the member associations of the DNVF. Metadata and rules of procedures are the starting point for the practical implementation of the register portal in the next future.

[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.

[Surgical patients with chronic pain or chronic postsurgical pain: a prospective analysis of psychological and social factors]. / Chirurgische Patienten mit chronischem Schmerz oder chronisch-postoperativem Schmerz : Eine prospektive Analyse psychologischer und sozialer Faktoren.

INTRODUCTION: The interference of biological, social, and psychological factors of the patient, collectively known as the biopsychosocial perspective, plays an important role in the chronification of postsurgical pain. The aim of this pilot study was to detect whether patients suffering from chronic pain without a relationship to a recent operation (CP) differ from chronic pain patients whose pain exists since a recent operation and is related with it (CPSP) in these factors. MATERIALS AND METHODS: A step-by-step analysis of patients with chronic pain was conducted via a questionnaire of 36 questions in which mental state, pain, fear, and depression [Hospital Anxiety and Depression Scale - Deutsche Version (HADS-D), Chronic Pain Grade Questionnaire (CPGQ, von Korff), SF-12, McGill Pain Questionnaire (sensoric/affective)] were surveyed. STATISTICAL ANALYSIS: Fisher's exact test for counts, U test for continuous variables; group comparisons with: χ(2) test; p < 0.05 was considered significant. RESULTS: On average 29 months postoperatively (24-35 ± 3.5 months), 113 chronic pain patients were analyzed. A group comparison between the CPSP group (n = 73 with chronic postsurgical pain) and the group CP (n = 29 with chronic pain) was conducted. Both groups showed highly significant reductions of SF-12 data compared to a German normal collective (p < 0.001), but normal results regarding depression in the HADS-D and a moderately limiting, highly pain-related limitation in the CPGQ (von Korff III). No differences in the sensoric and affective parameters of the McGill Pain Questionnaire were found. Compared with the CPSP group, the CP group demonstrated higher pain intensities (p = 0.022). CONCLUSION: Regarding these results critically, there were no group differences concerning psychological and social patient factors in chronic pain patients with or without postsurgical pain.

[Patient safety in health service research]. / Patientensicherheit in der Versorgungsforschung.

Patient safety is an essential quality criterion for good medical care. A main aim of patient safety interventions is the prevention and/or reduction of adverse events. Various approaches are available for this. The multidisciplinarity in health services research as well as the wide range of methods and topics leads to the fact that health services research is predestined to deal with many of the resulting research questions and with respect to the complexity.

[Pain therapy options in trauma and emergency surgery]. / Schmerztherapeutische Möglichkeiten in der Unfallchirurgie.

Sufficient acute pain therapy has been scientifically proven to be one of the therapeutic pillars for rapid patient convalescence, a low rate of pain chronification, and a high grade of patient satisfaction. This includes not only systemic pharmacological pain therapy, but also nonpharmaceutical measures, e.g., physical, psychological, locoregional, and adequate patient information. This requires a specific infrastructure, exact clinical control mechanisms, and fundamental knowledge about pain avoidance. The surgeon can responsibly contribute to this. The goal of the following article is to demonstrate and deepen this knowledge and to describe the newest scientific developments.

[Preparedness of hospital physicians for a mass casualty incident. A German survey amongst 7,700 physicians]. / Wie gut sind Ärzte auf einen Massenanfall von Verletzten vorbereitet?. Ergebnisse einer bundesweiten Umfrage bei 7700 Klinikärzten.

INTRODUCTION: The bomb attacks in Madrid (2004) and London (2005) have increased awareness that terrorist attacks are also a real threat in Germany. Hospitals and health care providers should be prepared. METHODS: We distributed an anonymous online questionnaire to physicians working in trauma centers of different categories. The results were analyzed using descriptive statistical methods. RESULTS: The questionnaire was returned by 1,204 of 7,700 physicians. This reflects a response rate of 15.6%. Of the participants, 53.3% answered that their hospital had a disaster control plan and that they knew the content; 33.9% reported that their hospital had participated in a disaster training scenario. CONCLUSION: As only 53.3% of physicians in hospitals know their disaster control plan and only 33.9% of hospitals have participated in a disaster training scenario we conclude that more action is needed to increase awareness of the problem. Furthermore standardized training programs are needed to disseminate knowledge and skills in order to enable health care providers to face the occurrence of terroristic attacks in Germany.

Evidence-based management of postoperative pain in adults undergoing open inguinal hernia surgery.

BACKGROUND: Open inguinal hernia repair is associated with moderate postoperative pain, but optimal analgesia remains controversial. The aim of this systematic review was to evaluate the available literature on the management of pain after open hernia surgery. METHODS: Randomized studies, in English, published between January 1966 and March 2009, assessing analgesic and anaesthetic interventions in adult open hernia surgery, and reporting pain scores, were retrieved from the Embase and MEDLINE databases. In addition to published evidence, clinical practice was taken into account to ensure that the recommendations had clinical validity. RESULTS: Of the 334 randomized studies identified, 79 were included. Quantitative analysis suggested that regional anaesthesia was superior to general anaesthesia for reducing postoperative pain. Spinal anaesthesia was associated with a higher incidence of urinary retention and increased time to home-readiness compared with regional anaesthesia. CONCLUSION: Field block with, or without wound infiltration, either as a sole anaesthetic/analgesic technique or as an adjunct to general anaesthesia, is recommended to reduce postoperative pain. Continuous local anaesthetic infusion of a surgical wound provides a longer duration of analgesia. Conventional non-steroidal anti-inflammatory drugs or cyclo-oxygenase 2-selective inhibitors in combination with paracetamol, administered in time to provide sufficient analgesia in the early recovery phase, are optimal. In addition, weak opioids are recommended for moderate pain, and strong opioids for severe pain, on request.

Prevention and treatment of bile duct injuries during laparoscopic cholecystectomy: the clinical practice guidelines of the European Association for Endoscopic Surgery (EAES).

BACKGROUND: Laparoscopic cholecystectomy is one of the most common surgical procedures in Europe (and the world) and has become the standard procedure for the management of symptomatic cholelithiasis or acute cholecystitis in patients without specific contraindications. Bile duct injuries (BDI) are rare but serious complications that can occur during a laparoscopic cholecystectomy. Prevention and management of BDI has given rise to a host of publications but very few recommendations, especially in Europe. METHODS: A systematic research of the literature was performed. An international expert panel was invited to appraise the current literature and to develop evidence-based recommendations. Statements and recommendations were drafted after a consensus development conference in May 2011, followed by presentation and discussion at the annual congress of the EAES held in Torino in June 2011. Finally, full guidelines were consented and adopted by the expert panel via e-mail and web conference. RESULTS: A total of 1,765 publications were identified through the systematic literature search and additional submission by panellists; 671 publications were selected as potentially relevant. Only 46 publications fulfilled minimal methodological criteria to support Clinical Practice Guidelines recommendations. Because the level of evidence was low for most of the studies, most statements or recommendations had to be based on consensus of opinion among the panel members. A total of 15 statements and recommendations were developed covering the following topics: classification of injuries, epidemiology, prevention, diagnosis, and management of BDI. CONCLUSIONS: Because BDI is a rare event, it is difficult to generate evidence for prevention, diagnosis, or the management of BDI from clinical studies. Nevertheless, the panel has formulated recommendations. Due to the currently limited evidence, a European registry should be considered to collect and analyze more valid data on BDI upon which recommendations can be based.

[Quality management in acute pain therapy: results from a survey of certified hospitals]. / Qualitätsmanagement in der Akutschmerztherapie : Ergebnisse einer Befragung TÜV-zertifizierter Kliniken.

AIM: Systems for and methods of quality management are increasingly being implemented in public health services. The aim of our study was to analyze the current state of the integrated quality management concept "quality management acute pain therapy" of the TÜV Rheinland® (TÜV) after a 5-year project period. MATERIAL AND METHODS: General characteristics of the participating hospitals, number of departments certified by the TÜV and implementation of structures and processes according to the TÜV guidelines were evaluated by a mail questionnaire. Furthermore, positive and negative aspects concerning the effects of certification were evaluated by the hospitals' representatives of certification. RESULTS: A total of 36 questionnaires were returned. Since 2006 the number of certified hospitals (2011: n = 48) and surgical departments (2011: n = 202) has increased continuously. The number of certified medical departments is low (2011: n = 39); however, in the last 3 years, it has increased by about 200-300% annually. Standard operative procedures for pain therapy and measurement of pain intensity at regular intervals were implemented in all certified clinics (100%). Although 41% take part in the benchmarking project QUIPS (Quality Improvement in Postoperative Pain Therapy), 24% do not systematically check the quality of the outcome of pain management. Acceptance of the new pain therapy concepts among nursing staff was rated positively (ratio positive:negative 16:1); however, acceptance among physicians was rated negatively (1:15). CONCLUSION: Certification by the TÜV leads to sustainable implementation of quality management principles. Future efforts should focus on better integration of physicians in acute pain therapy and the development of an integrated tool to measure patients' outcome.

Laparoscopic extraperitoneal rectal cancer surgery: the clinical practice guidelines of the European Association for Endoscopic Surgery (EAES).

BACKGROUND: The laparoscopic approach is increasingly applied in colorectal surgery. Although laparoscopic surgery in colon cancer has been proved to be safe and feasible with equivalent long-term oncological outcome compared to open surgery, safety and long-term oncological outcome of laparoscopic surgery for rectal cancer remain controversial. Laparoscopic rectal cancer surgery might be efficacious, but indications and limitations are not clearly defined. Therefore, the European Association for Endoscopic Surgery (EAES) has developed this clinical practice guideline. METHODS: An international expert panel was invited to appraise the current literature and to develop evidence-based recommendations. The expert panel constituted for a consensus development conference in May 2010. Thereafter, the recommendations were presented at the annual congress of the EAES in Geneva in June 2010 in a plenary session. A second consensus process (Delphi process) of the recommendations with the explanatory text was necessary due to the changes after the consensus conference. RESULTS: Laparoscopic surgery for extraperitoneal (mid- and low-) rectal cancer is feasible and widely accepted. The laparoscopic approach must offer the same quality of surgical specimen as in open surgery. Short-term outcomes such as bowel function, surgical-site infections, pain and hospital stay are slightly improved with the laparoscopic approach. Laparoscopic resection of rectal cancer is not inferior to the open in terms of disease-free survival, overall survival or local recurrence. Laparoscopic pelvic dissection may impair genitourinary and sexual function after rectal resection, like in open surgery. CONCLUSIONS: Laparoscopic surgery for mid- and low-rectal cancer can be recommended under optimal conditions. Still, most level 1 evidence is for colon cancer surgery rather than rectal cancer. Upcoming results from large randomised trials are awaited to strengthen the evidence for improved short-term results and equal long-term results in comparison with the open approach.

[Evaluation of the "initiative pain-free clinic" for quality improvement in postoperative pain management. A prospective controlled study]. / Evaluation der "Initiative Schmerzfreie Klinik" zur Qualitätsverbesserung in der postoperativen Schmerztherapie. Eine prospektive kontrollierte Studie.

AIM: Demonstration of improved postoperative pain management by implementation of the S3 guidelines on treatment of acute perioperative and posttraumatic pain, by the integrated quality management concept "quality management acute pain" of the TÜV Rheinland or by participation in the benchmark project "Quality improvement in postoperative pain management" (QUIPS). METHODS: A prospective controlled study (pre-post design) was carried out in hospitals with various levels of care comparing three hospital groups (n = 17/7/3, respectively). Group 1: participation in the QUIPS project (intraclinic and interclinic comparison of outcome data of postoperative pain treatment), group 2: participation in the quality management acute pain program (certified by TÜV Rheinland), group 3: control group with no involvement in either of the two concepts. In all three groups, an anonymous data collection was performed consisting of patient-reported pain intensity, side effects, pain disability and patient satisfaction. Pain therapy intervention was carried out only in group 2 by an integrated quality management concept (certification project: Quality management acute pain) with a package of measures to improve structure, process and outcome quality. RESULTS: The TÜV Rheinland certified clinics (group 2) showed a significant improvement in the pre-post comparison (before versus after certification) in the areas maximum pain (from visual analogue scale VAS 4.6 to 3.7), stress pain (5.3 to 3.9), pain-related impairment (proportion of patients with pain-linked decreased mobility and movement 26% to 16.1%, coughing and breathing 23.1% to 14.3%) and patient satisfaction (from 13.2 to 13.7; scale 0 completely unsatisfied, 15 very satisfied). The clinics with participation in QUIPS for 2 years also showed a significant improvement in stress pain (numeric rating scale NRS for pain 4.5 to 4.2), pain-linked-limitation of coughing and breathing (28% to 23.6%), and patient satisfaction (from 11.9 to 12.4). There were no differences in postoperative nausea and vomiting between any of the groups. CONCLUSIONS: The main objective of the certification concept quality management acute pain as a tool for the successful implementation of the S3 guidelines on treatment of acute perioperative and posttraumatic pain, led to a significant improvement in patient outcome. Participation in QUIPS is an ideal supplement to TÜV Rheinland certification and can be recommended as a benchmarking tool to evaluate outcome.

Evidence-based management of pain after haemorrhoidectomy surgery.

BACKGROUND: Haemorrhoidectomy is associated with intense postoperative pain, but optimal evidence-based pain therapy has not been described. The aim of this systematic review was to evaluate the available literature on the management of pain after haemorrhoidal surgery. METHODS: Randomized studies published in the English language from 1966 to June 2006, assessing analgesic and anaesthetic interventions in adult haemorrhoidal surgery, and reporting pain scores, were retrieved from the Embase and MEDLINE databases. RESULTS: Of the 207 randomized studies identified, 106 met the inclusion criteria, with mixed methodological quality. Of these, 41 studies evaluating surgical and alternative interventions were excluded. Quantitative analyses were not performed, as there were limited numbers of trials with a sufficiently homogeneous design. CONCLUSION: Local anaesthetic infiltration, either as a sole technique or as an adjunct to general or regional anaesthesia, and combinations of analgesics (non-steroidal anti-inflammatory drugs, paracetamol and opiates) are recommended. If appropriate, a stapled operation may be preferable.

[Memorandum III: Methods for Health Services Research (Part 2)]. / Memorandum III: Methoden für die Versorgungsforschung (Teil 2)*

The methodical quality of health services research studies is often subject to criticism. Common standards in the field of health services research have been lacking so far. Hence, the German Network for Health Services Research [Deutsches Netzwerk Versorgungsforschung e. V. (DNVF e. V.)] decided to contribute to an improvement of this situation. The DNVF e. V. has already published part 1 of the Memorandum III"Methods for Health Services Research" for the 3 subject areas "Epidemiological Methods for Health Services Research", "Methods for Organisational Health Services Research" and "Methods for Quality of Life Research". The herewith published Part 2 of the Memorandum extends the spectrum by describing the methodological principles and minimum standards of "Methods of Health Economic Evaluations" and "Registries for Health Services Research". On 30 (th) August 2010, the member societies, mentioned as authors, approved this second part of the Memorandum III. 2 in-depth publications focussing on the 2 mentioned topics will be published in the next issues of this journal. This memorandum is intended for health services researchers who are planning, conducting and publishing studies as well as for reviewers who evaluate research proposals and publications on health services research studies. In accord with the expected advances in knowledge in health services research, it is planned to update the 2 parts of Memorandum III at appropriate intervals and to publish further parts from the huge spectrum of methods relevant to this field in the near future. Thus, the Memorandum has to be considered as work in progress.

[Memorandum registry for health services research]. / Memorandum Register für die Versorgungsforschung.

On August 30, 2010, the German Network for Health Services Research [Deutsches Netzwerk Versorgungsforschung e. V. (DNVF e. V.)] approved the Memorandum III "Methods for Health Services Research", supported by their member societies mentioned as authors and published in this Journal [Gesundheitswesen 2010; 72: 739-748]. Registries in Health Services Research vary in their aims and research questions as well as in their designs, methods of data collection, and statistical analyses. This paper aims to provide both a methodological guideline for developers to ensure a high quality of a planned registry and, to provide an instrument for users of data from registries to assess their overall quality. First, the paper provides a definition of registries and presents an overview of objectives in Health Services Research where registries can be useful. Second, several areas of methodological importance for the development of registries are presented. This includes the different phases of a registry (i. e., conceptual and preliminary design, implementation), technical organisation of a registry, statistical analysis, reporting of results, data protection, and ethical/legal aspects. From these areas, several criteria are deduced to allow the assessment of the quality of a registry. Finally, a checklist to assess a registry's quality is presented.

[Memorandum III: "Methods for Health Services Research" (Part 1)]. / Memorandum III: Methoden für die Versorgungsforschung (Teil I).

The methodical quality of health services research studies is often subject to criticism. Common standards in the field of health services research have been lacking so far. Hence, the German Network Health Services Research [Deutsches Netzwerk Versorgungsforschung e.V. (DNVF e.V.)] decided to contribute to improve this situation. On 1 July 2009, the DNVF e.V. approved the Memorandum III "Methods for Health Services Research", supported by the member societies mentioned as authors. For the three subject areas "Epidemiological Methods for Health Services Research", "Methods for Organisational Health Services Research" and "Methods for Quality of Life Research", this Memorandum describes the methodological principles and minimum standards which should be adhered to when conducting and publishing health services research studies. Three in-depth publications focussing on the three mentioned topics will be published in the next issues of this journal. This memorandum is intended for health services researchers who are planning, conducting and publishing studies as well as for reviewers who evaluate research proposals and publications on health services research studies. In accord with the expected advances in knowledge in health services research, it is planned to update the Memorandum III (part 1) at appropriate intervals and to publish part 2 in the near future. Thus, the Memorandum has to be considered as work in progress.

[Assessment of quality of life in health services research - conceptual, methodological and structural prerequisites]. / Die Erfassung von Lebensqualität in der Versorgungsforschung - konzeptuelle, methodische und strukturelle Voraussetzungen.

On July 1, 2009, the German Network for Health Services Research [Deutsches Netzwerk Versorgungsforschung e. V. (DNVF e. V.)] approved the Memorandum III "Methods for Health Services Research", supported by the member societies mentioned as authors and published in this Journal [Gesundheitswesen 2009; 71: 505-510]. This is an in-depth publication on "quality-of-life assessment in health services research". Within the context of the health sciences, quality of life (QL) encompasses the subjective well-being and functioning in the physical, psychological and social domains. QL informs about the aspects of health care that "actually get to the patient". QL is what patients primarily experience, what they talk about and what to a large degree affects the acceptance of health-care services and processes in the society. Therefore, QL can be considered as a highly important endpoint within health services research. The importance of the construct quality of life is also emphasised in German treaties on social law and utility analyses. This paper is the first account on the relations between health services research and the concept and assessment of QL. Our working group has specified key criteria for QL assessment within studies on health services research. (1) Assessment instruments need to comply with standard quality criteria (reliability, validity, sensitivity, interpretability) and the decision for a particular instrument has to be reasonably justified. (2) Study design and study population have to match with the scientific research question and the sample size has to be biometrically sound. (3) QL assessment including time points over the course of the study has to follow a standardized protocol. (4) Criteria for analysis and interpretation have to be prospectively specified. (5) Studies focusing on diagnostic/therapeutic issues need to specify standards for diagnostic criteria and related therapeutic interventions.