Social media attention and citations of published outputs from re-use of clinical trial data: a matched comparison with articles published in the same journals.

BACKGROUND: Data-sharing policies in randomized clinical trials (RCTs) should have an evaluation component. The main objective of this case-control study was to assess the impact of published re-uses of RCT data in terms of media attention (Altmetric) and citation rates. METHODS: Re-uses of RCT data published up to December 2019 (cases) were searched for by two reviewers on 3 repositories (CSDR, YODA project, and Vivli) and matched to control papers published in the same journal. The Altmetric Attention Score (primary outcome), components of this score (e.g. mention of policy sources, media attention) and the total number of citations were compared between these two groups. RESULTS: 89 re-uses were identified: 48 (53.9%) secondary analyses, 34 (38.2%) meta-analyses, 4 (4.5%) methodological analyses and 3 (3.4%) re-analyses. The median (interquartile range) Altmetric Attention Scores were 5.9 (1.3-22.2) for re-use and 2.8 (0.3-12.3) for controls (p = 0.14). No statistical difference was found on any of the components of in the Altmetric Attention Score. The median (interquartile range) numbers of citations were 3 (1-8) for reuses and 4 (1 - 11.5) for controls (p = 0.30). Only 6/89 re-uses (6.7%) were cited in a policy source. CONCLUSIONS: Using all available re-uses of RCT data to date from major data repositories, we were not able to demonstrate that re-uses attracted more attention than a matched sample of studies published in the same journals. Small average differences are still possible, as the sample size was limited. However matching choices have some limitations so results should be interpreted very cautiously. Also, citations by policy sources for re-uses were rare. TRIAL REGISTRATION: Registration: osf.io/fp62e.

Health care utilization and excess costs after pelvic fractures among older people in Germany.

Our study demonstrates a strong increase in utilization of inpatient health care and clear excess costs in older people in the first year after pelvic fracture, the latter even after adjustment for several confounders. Excess costs were particularly high in the first few months and mainly attributable to inpatient treatment. INTRODUCTION: We aimed to estimate health care utilization and excess costs in patients aged minimum 60 years up to 1 year after pelvic fracture compared to a population without pelvic fracture. METHODS: In this retrospective population-based observational study, we used routine data from a large statutory health insurance (SHI) in Germany. Patients with a first pelvic fracture between 2008 and 2010 (n=5685, 82% female, mean age 80±9 years) were frequency matched with controls (n=193,159) by sex, age at index date, and index month. We estimated health care utilization and mean total direct costs (SHI perspective) with 95% confidence intervals (CIs) using BCA bootstrap procedures for 52 weeks before and after the index date. We calculated cost ratios (CRs) in 4-week intervals after the index date by fitting mixed two-part models including adjustment for possible confounders and repeated measurement. All analyses were further stratified for men/women, in-/outpatient-treated, and major/minor pelvic fractures. RESULTS: Health care utilization and mean costs in the year after the index date were higher for cases than for controls, with inpatient treatment being particularly pronounced. CRs (95% CIs) decreased from 10.7 (10.2-11.1) within the first 4 weeks to 1.3 (1.2-1.4) within week 49-52. Excess costs were higher for inpatient than for outpatient-treated persons (CRs of 13.4 (12.9-13.9) and 2.3 (2.0-2.6) in week 1-4). In the first few months, high excess costs were detected for both persons with major and minor pelvic fracture. CONCLUSION: Pelvic fractures come along with high excess costs and should be considered when planning and allocating health care resources.

Towards a European health research and innovation cloud (HRIC).

The European Union (EU) initiative on the Digital Transformation of Health and Care (Digicare) aims to provide the conditions necessary for building a secure, flexible, and decentralized digital health infrastructure. Creating a European Health Research and Innovation Cloud (HRIC) within this environment should enable data sharing and analysis for health research across the EU, in compliance with data protection legislation while preserving the full trust of the participants. Such a HRIC should learn from and build on existing data infrastructures, integrate best practices, and focus on the concrete needs of the community in terms of technologies, governance, management, regulation, and ethics requirements. Here, we describe the vision and expected benefits of digital data sharing in health research activities and present a roadmap that fosters the opportunities while answering the challenges of implementing a HRIC. For this, we put forward five specific recommendations and action points to ensure that a European HRIC: i) is built on established standards and guidelines, providing cloud technologies through an open and decentralized infrastructure; ii) is developed and certified to the highest standards of interoperability and data security that can be trusted by all stakeholders; iii) is supported by a robust ethical and legal framework that is compliant with the EU General Data Protection Regulation (GDPR); iv) establishes a proper environment for the training of new generations of data and medical scientists; and v) stimulates research and innovation in transnational collaborations through public and private initiatives and partnerships funded by the EU through Horizon 2020 and Horizon Europe.

European survey on national training activities in clinical research.

BACKGROUND: Investigator-initiated clinical studies (IITs) are crucial to generate reliable evidence that answers questions of day-to-day clinical practice. Many challenges make IITs a complex endeavour, for example, IITs often need to be multinational in order to recruit a sufficient number of patients. Recent studies highlighted that well-trained study personnel are a major factor to conduct such complex IITs successfully. As of today, however, no overview of the European training activities, requirements and career options for clinical study personnel exists. METHODS: To fill this knowledge gap, a survey was performed in all 11 member and observer countries of the European Clinical Research Infrastructure Network (ECRIN), using a standardised questionnaire. Three rounds of data collection were performed to maximize completeness and comparability of the received answers. The survey aimed to describe the landscape of academic training opportunities, to facilitate the exchange of expertise and experience among countries and to identify new fields of action. RESULTS: The survey found that training for Good Clinical Practice (GCP) and investigator training is offered in all but one country. A specific training for study nurses or study coordinators is also either provided or planned in ten out of eleven countries. A majority of countries train in monitoring and clinical pharmacovigilance and offer specific training for principal investigators but only few countries also train operators of clinical research organisations (CRO) or provide training for methodology and quality management systems (QMS). Minimal requirements for study-specific functions cover GCP in ten countries. Only three countries issued no requirements or recommendations regarding the continuous training of study personnel. Yet, only four countries developed a national strategy for training in clinical research and the career options for clinical researchers are still limited in the majority of countries. CONCLUSIONS: There is a substantial and impressive investment in training and education of clinical research in the individual ECRIN countries. But so far, a systematic approach for (top-down) strategic and overarching considerations and cross-network exchange is missing. Exchange of available curricula and sets of core competencies between countries could be a starting point for improving the situation.

Raising standards in clinical research - The impact of the ECRIN data centre certification programme, 2011-2016.

The nature and the purpose of the ECRIN Data Centre Certification Programme are summarised, and a very brief description is given of the underlying standards (129 in total, divided into 19 separate lists). The certification activity performed so far is described. In a pilot phase 2 centres were certified in 2012. Calls in 2014 and 2015 resulted in a further 8 certified centres, with 2 certifications still in progress, and the 2016 call has generated several additional applications. The impact and benefits of the programme are listed, divided into a) the effects of the introduction of the standards, b) the effects of the certification programme in general, and c) the effects of the certification programme on individual units. The discussion emphasises the generally positive impact of the programme so far but stresses the need to better clarify the perspective and role of the programme.

Structural brain changes are associated with response of negative symptoms to prefrontal repetitive transcranial magnetic stimulation in patients with schizophrenia.

Impaired neural plasticity may be a core pathophysiological process underlying the symptomatology of schizophrenia. Plasticity-enhancing interventions, including repetitive transcranial magnetic stimulation (rTMS), may improve difficult-to-treat symptoms; however, efficacy in large clinical trials appears limited. The high variability of rTMS-related treatment response may be related to a comparably large variation in the ability to generate plastic neural changes. The aim of the present study was to determine whether negative symptom improvement in schizophrenia patients receiving rTMS to the left dorsolateral prefrontal cortex (DLPFC) was related to rTMS-related brain volume changes. A total of 73 schizophrenia patients with predominant negative symptoms were randomized to an active (n=34) or sham (n=39) 10-Hz rTMS intervention applied 5 days per week for 3 weeks to the left DLPFC. Local brain volume changes measured by deformation-based morphometry were correlated with changes in negative symptom severity using a repeated-measures analysis of covariance design. Volume gains in the left hippocampal, parahippocampal and precuneal cortices predicted negative symptom improvement in the active rTMS group (all r⩽-0.441, all P⩽0.009), but not the sham rTMS group (all r⩽0.211, all P⩾0.198). Further analyses comparing negative symptom responders (⩾20% improvement) and non-responders supported the primary analysis, again only in the active rTMS group (F(9, 207)=2.72, P=0.005, partial η 2=0.106). Heterogeneity in clinical response of negative symptoms in schizophrenia to prefrontal high-frequency rTMS may be related to variability in capacity for structural plasticity, particularly in the left hippocampal region and the precuneus.

Randomized controlled trial on the efficacy of new alcohol-free chlorhexidine mouthrinses after 8 weeks.

OBJECTIVES: To evaluate the efficacy of two alcohol-free antimicrobial mouthrinses in reducing plaque and gingivitis compared to an alcohol-containing rinse and toothbrushing alone. METHODS: One hundred and sixty healthy volunteers were enrolled in the randomized controlled trial. Participants were randomly and equally assigned to four groups: (i) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-containing rinse, positive control); (ii) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-free experimental rinse); (iii) toothbrushing + rinsing (0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free experimental rinse); (iv) toothbrushing alone (negative control). At baseline, Quigley-Hein plaque index (QHI), modified proximal plaque index (MPPI), and papillary bleeding index (PBI) were recorded. All subjects brushed their teeth as usual during the study. Additionally, groups 1-3 rinsed twice daily. Eight weeks after baseline, indices were recorded again. anova with Bonferroni adjustment served for statistical analysis. RESULTS: One hundred and fifty-five participants were included into final analysis (i: n = 39, 2: n = 39, 3: n = 37, 4: n = 40). Experimental rinses (ii, iii) reduced QHI and MPPI to a higher extent than the negative control (iv), whereas no significant difference to the positive control was found. QHI: (i) 36.6%, (ii) 32.3%, (iii) 36.8%, (iv) 21.6%; MPPI: (i) 11.9%, (ii) 12.2%, (iii) 13.6%, (iv) 3.5%. For PBI, no statistically significant difference was found between groups: (i) 80.2%, (ii) 77.8%, (iii) 76.5% and (iv) 78.8%. CONCLUSIONS: With respect to QHI and MPPI, toothbrushing in combination with any rinse was more effective than toothbrushing alone. No statistically significant differences were found between the alcohol-free and the alcohol-containing control rinses.

[Prevention of Type 2 Diabetes: Evidence-Based Patient Information--A Randomised Controlled Trial]. / Effekt einer evidenzbasierten Patienteninformation zur Prävention von Typ 2-Diabetes.

The aim of this study was to compare the effect of our newly developed online evidence-based patient information (EBPI) vs. standard patient information about subthreshold elevated blood glucose levels and primary prevention of diabetes on informed patient decision-making. EBPI significantly improved knowledge about elevated glucose levels, but also increased decisional conflict and critical attitudes to screening and treatment options. The intention to undergo metabolic screening decreased as a result.

Design and multicentric implementation of a generic software architecture for patient recruitment systems re-using existing HIS tools and routine patient data.

OBJECTIVE: (1) To define features and data items of a Patient Recruitment System (PRS); (2) to design a generic software architecture of such a system covering the requirements; (3) to identify implementation options available within different Hospital Information System (HIS) environments; (4) to implement five PRS following the architecture and utilizing the implementation options as proof of concept. METHODS: Existing PRS were reviewed and interviews with users and developers conducted. All reported PRS features were collected and prioritized according to their published success and user's request. Common feature sets were combined into software modules of a generic software architecture. Data items to process and transfer were identified for each of the modules. Each site collected implementation options available within their respective HIS environment for each module, provided a prototypical implementation based on available implementation possibilities and supported the patient recruitment of a clinical trial as a proof of concept. RESULTS: 24 commonly reported and requested features of a PRS were identified, 13 of them prioritized as being mandatory. A UML version 2 based software architecture containing 5 software modules covering these features was developed. 13 data item groups processed by the modules, thus required to be available electronically, have been identified. Several implementation options could be identified for each module, most of them being available at multiple sites. Utilizing available tools, a PRS could be implemented in each of the five participating German university hospitals. CONCLUSION: A set of required features and data items of a PRS has been described for the first time. The software architecture covers all features in a clear, well-defined way. The variety of implementation options and the prototypes show that it is possible to implement the given architecture in different HIS environments, thus enabling more sites to successfully support patient recruitment in clinical trials.

Feasibility of 6-month maintenance cetuximab after adjuvant concurrent chemoradiation plus cetuximab in squamous cell carcinoma of the head and neck.

BACKGROUND: Close resection margins < 5 mm (CM) or extra capsular extent at the lymph nodes (ECE) impair the prognosis of patients with squamous cell cancer of the head and neck (SCCHN) scheduled for adjuvant radiochemotherapy. We conducted a multicenter phase II study to investigate toxicity and efficacy of additional cetuximab administered concomitantly and as maintenance for the duration of 6 months following adjuvant radiochemotherapy., Ppreliminary results on feasibility and acute toxicity on skin and mucosa are presented in this article. METHODS: Patients with SCCHN following CM resection or with ECE were eligible for the study. In all, 61.6 Gy (1.8/2.0/2.2 Gy, days 1-36) were administered using an integrated boost intensity-modulated radiotherapy (IMRT) technique. Cisplatin (20 mg/m(2), days 1-5 and days 29-33) and 5-fluorouracil (5-FU) as continuous infusion (600 mg/m(2), days 1-5 + days 29-33) were given concurrently. Cetuximab was started 7 days prior to radiochemotherapy at 400 mg/m(2) followed by weekly doses of 250 mg/m(2). Maintenance cetuximab began after radiochemotherapy at 500 mg/m(2) every 2 weeks for 6 months. RESULTS: Of the 55 patients (46 male, 9 female, mean age 55.6, range 29-70 years) who finished radiochemotherapy, 50 were evaluable for acute toxicity concerning grade III/IV toxicities of skin and mucosa. Grade 3-4 (CTC 3.0) mucositis, radiation dermatitis, and skin reactions outside the radiation portals were documented for 46, 28, and 14 % of patients, respectively. One toxic death occurred (peritonitis at day 57). Cetuximab was terminated in 5 patients due to allergic reactions after the first application. In addition, 22 % of patients discontinued cetuximab within the last 2 weeks or at the end of radiochemotherapy. Of patients embarking on maintenance treatment, 80 % were still on cetuximab at 3 months and 63 % at 5 months. Concurrent and maintenance treatment with cetuximab could be administered as scheduled in 48 % of patients. CONCLUSION: Adjuvant radiochemotherapy with concomitant and maintenance cetuximab is feasible and acute toxicities are within the expected range. Compliance within the first 3-5 months is moderate.

Blood glucose testing and primary prevention of Type 2 diabetes-evaluation of the effect of evidence-based patient information: a randomized controlled trial.

AIMS: To compare the effect of our newly developed online evidence-based patient information vs. standard patient information about sub-threshold elevated blood glucose levels and primary prevention of diabetes on informed patient decision making. METHODS: We invited visitors to the cooperating health insurance company, Techniker Krankenkasse, and the German Diabetes Center websites to take part in a web-based randomized controlled trial. The population after randomization comprised 1120 individuals aged between 40 and 70 years without known diabetes, of whom 558 individuals were randomly assigned to the intervention group receiving evidence-based patient information, and 562 individuals were randomly assigned to the control group receiving standard information from the Internet. The primary endpoint was acquired knowledge of elevated blood glucose level issues and the secondary outcomes were attitude to metabolic testing, intention to undergo metabolic testing, decisional conflict and satisfaction with the information. RESULTS: Overall, knowledge of elevated glucose level issues and the intention to undergo metabolic testing were high in both groups. Participants who had received evidence-based patient information, however, had significantly higher knowledge scores. The secondary outcomes in the evidence-based patient information subgroup that completed the 2-week follow-up period yielded significantly lower intention to undergo metabolic testing, significantly more critical attitude towards metabolic testing and significantly higher decisional conflict than the control subgroup (n=466). Satisfaction with the information was not significantly different between both groups. CONCLUSIONS: Evidence-based patient information significantly increased knowledge about elevated glucose levels, but also increased decisional conflict and critical attitude to screening and treatment options. The intention to undergo metabolic screening decreased. Future studies are warranted to assess uptake of metabolic testing and satisfaction with this decision in a broader population of patients with unknown diabetes.

Brief psychodynamic interpersonal psychotherapy for patients with multisomatoform disorder: randomised controlled trial.

BACKGROUND: Multisomatoform disorder is characterised by severe and disabling bodily symptoms, and pain is one of the most common and impairing of these. Furthermore, these bodily symptoms cannot be explained by an underlying organic disorder. Patients with multisomatoform disorder are commonly found at all levels of healthcare and are typically difficult to treat for physicians as well as for mental health specialists. AIMS: To test whether brief psychodynamic interpersonal therapy (PIT) effectively improves the physical quality of life in patients who have had multisomatoform disorder for at least 2 years. METHOD: We recruited 211 patients (from six German academic outpatient centres) who met the criteria for multisomatoform disorder for a randomised, controlled, 12-week, parallelgroup trial from 1 July 2006 to 1 January 2009 (International Standard Randomised Controlled Trial Number ISRCTN23215121). We randomly assigned the patients to receive either 12 weekly sessions of PIT (n = 107) or three sessions of enhanced medical care (EMC, n = 104). The physical component summary of the Short Form Health Survey (SF-36) was the pre-specified primary outcome at a 9-month follow-up. RESULTS: Psychodynamic interpersonal therapy improved patients' physical quality of life at follow-up better than EMC (mean improvement in SF-36 score: PIT 5.3, EMC 2.2), with a small to medium between-group effect size (d = 0.42, 95% CI 0.15-0.69, P = 0.001). We also observed a significant improvement in somatisation but not in depression, health anxiety or healthcare utilisation. CONCLUSIONS: This trial documents the long-term efficacy of brief PIT for improving the physical quality of life in patients with multiple, difficult-to-treat, medically unexplained symptoms.

[Distances to hospitals performing minimum volume relevant procedures in Germany 2004 to 2006]. / Distanzen zu Krankenhäusern mit Mindestmengen-relevanten Eingriffen 2004 bis 2006.

INTRODUCTION: In 2004, Germany introduced annual minimum volumes nationwide on five surgical procedures (kidney, liver, stem cell transplantation, complex oesophageal, and pancreatic interventions). In 2006, minimum volumes for total knee prosthesis were added and the five established minimum volumes were almost doubled. Since minimum volumes usually result in the regionalisation of procedures, especially patients from rural areas are impeded by geographical access problems. The aim of our study was to analyse regional and time-related differences in the distances patients travelled to hospitals performing minimum volume relevant procedures between 2004 and 2006 in Germany. METHODS: We performed a secondary analysis of data from the Institute for the Hospital Remuneration System (InEK). Using a geographical information system we analysed the distances that patients who underwent one of the six minimum volume procedures travelled to the hospital in the years 2004-2006. We performed t-tests to analyse differences between the 16 German Federal States and the years of observation while correcting for multiple testing. RESULTS: On average patients travelled between 28.6/28.0 km (2004/2006) for knee prosthesis and 78.9 km for stem cell transplantation (2004) and 97.4 km for liver transplantation (2006). In 2004, distances travelled differed up to a factor of 9.9 [comparing distances travelled to stem cell transplantation of patients of the states of Berlin (30.6 km) and Hamburg (303 km)]. In 2006, the maximum difference (factor 12.2) was observed for oesophageal interventions comparing distances travelled in the states of Bremen (7.2 km) and Saarland (88.8 km). For almost all comparisons there were significant differences of the minimum and maximum distances travelled in one of the Federal States compared to the federal average. Comparing distances travelled in 2004 and 2006 we found only small and inconsistent variations. DISCUSSION: We found that geographical access to inpatient care for minimum volume procedures in Germany differs sizably between the Federal States in 2004 and 2006. In spite of doubling the minimum volumes in 2006, the distances patients travelled to hospitals hardly change. This may be caused by an inert implementation of the minimum volume regulation leading to an unchanged number of hospitals providing the respective procedures.

Repetitive transcranial magnetic stimulation for the treatment of negative symptoms in residual schizophrenia: rationale and design of a sham-controlled, randomized multicenter study.

Current meta-analysis revealed small, but significant effects of repetitive transcranial magnetic stimulation (rTMS) on negative symptoms in patients with schizophrenia. There is a need for further controlled, multicenter trials to assess the clinical efficacy of rTMS on negative symptoms in schizophrenia in a larger sample of patients. The objective of this multicenter, randomized, sham-controlled, rater- and patient-blind clinical trial is to investigate the efficacy of 3-week 10-Hz high frequency rTMS add on to antipsychotic therapy, 15 sessions per 3 weeks, 1,000 stimuli per session, stimulation intensity 110% of the individual motor threshold) of the left dorsolateral prefrontal cortex for treating negative symptoms in schizophrenia, and to evaluate the effect during a 12 weeks of follow-up. The primary efficacy endpoint is a reduction of negative symptoms as assessed by the negative sum score of the positive and negative symptom score (PANSS). A sample size of 63 in each group will have 80% power to detect an effect size of 0.50. Data analysis will be based on the intention to treat population. The study will be conducted at three university hospitals in Germany. This study will provide information about the efficacy of rTMS in the treatment of negative symptoms. In addition to psychopathology, other outcome measures such as neurocognition, social functioning, quality of life and neurobiological parameters will be assessed to investigate basic mechanisms of rTMS in schizophrenia. Main limitations of the trial are the potential influence of antipsychotic dosage changes and the difficulty to ensure adequate blinding.

CDISC standard-based electronic archiving of clinical trials.

OBJECTIVES: Our objectives were to develop, based on the analysis of archived clinical trial documents and data and on the requirements of GCP-compliant electronic archiving, a concept for legally secure and technically feasible archiving of the entire clinical trial, including the essential documents of the trial master file and the study database. METHODS: Based on own experiences with CDISC, existing implementations and future developments, CDISC standards were evaluated concerning requirements for archiving clinical studies. Trial master files of a small, medium and large clinical study were analyzed to collect specifications for electronic archiving of records. RESULTS: Two different ways of long-term storage exist for the clinical trial archive: document-oriented archival and data archiving of the study database. The trial master file has a highly complex structure; its different parts can vary greatly in size, depending of the working style of investigators, number of patients recruited, the number of adverse event reports and the number of queries. The CDISC standard ODM is especially suited for archiving clinical trials, because among other features it contains the entire clinical trial data and full audit trail information. On the other hand SDTM is a content standard suited for data warehouses. Two recent developments in CDISC will affect the archival of studies: the further development of ODM in the area of "eCRF submission" and the use of "Electronic Source Data". CONCLUSIONS: The complexity and size of the trial master file requires new solutions. Though ODM provides effective means to archive the study database, it shows still deficiencies, especially for the joint archiving of data and the complex documentation of the trial master file. A concept was developed in which the ODM standard is part of an integrated archiving of the trial data and documents. ODM archiving of the study database enables long-term storage which is GCP-compliant. Archiving of documents of the trial master file in PDF/A, including links and electronic signatures, as well as the storage of selected study data in a data warehouse at the sponsor site in SDTM are the other components of the concept.

Necrotizing fasciitis: microbiological characteristics and predictors of postoperative outcome.

OBJECTIVE: Necrotizing fasciitis is a life threatening soft-tissue infection with a high morbidity and mortality. Prompt treatment based on extensive surgical debridement and antibiotic therapies are the therapeutic principles. METHODS: The medical records of patients with necrotizing fasciitis (n = 26) from 1996 to 2005 were retrospectively analyzed. RESULTS: The localization of necrotizing fasciitis was most commonly the trunk (42.3 %). Type I polymicrobial infection was the dominating infection. The involvement of anaerobic bacteria was associated with an increase in the number of surgical revisions (p = 0.005). Length of postoperative intensive care unit stay, duration of postoperative ventilation and mortality were significantly increased in the ASA IV-V group. Computed tomography displayed only a limited significance as diagnostic tool for initial diagnosis. CONCLUSIONS: In severe cases the combination of necrotic skin and soft tissue gas facilitates the correct diagnosis, which should than be followed by immediate - and most often - repeated debridement. If anaerobes are isolated an early and aggressive second look is necessary.

Future developments of medical informatics from the viewpoint of networked clinical research. Interoperability and integration.

OBJECTIVES: To be prepared for future developments, such as enabling support of rapid innovation transfer and personalized medicine concepts, interoperability of basic research, clinical research and medical care is essential. It is the objective of our paper to give an overview of developments, indicate problem areas and to specify future requirements. METHODS: In this paper recent and ongoing large-scaled activities related to interoperability and integration of networked clinical research are described and evaluated. The following main topics are covered: necessity for general IT-conception, open source/open community approach, acceptance of eSource in clinical research, interoperability of the electronic health record and electronic data capture and harmonization and bridging of standards for technical and semantic interoperability. RESULTS: National infrastructures and programmes have been set up to provide general IT-conceptions to guide planning and development of software tools (e.g. TMF, caBIG, NIHR). The concept of open research described by transparency achieved through open access, open data, open communication and open source software is becoming more and more important in clinical research infrastructure development (e.g. caBIG, ePCRN). Meanwhile visions and rules for using eSource in clinical research are available, with the potential to improve interoperability between the electronic health record and electronic data capture (e.g. CDISC eSDI, eClinical Forum/PhRMA EDC/eSource Taskforce). Several groups have formulated user requirements, use cases and technical frameworks to advance these issues (e.g. NHIN Slipstream-project, EHR/CR-project, IHE). In order to achieve technical and semantic interoperability, existing standards (e.g. CDISC) have to be harmonized and bridged. Major consortia have been formed to provide semantical interoperability (e.g. HL7 RCRIM under joint leadership of HL7, CDISC and FDA, or BRIDG covering CDISC, HL7, FDA, NCI) and to provide core sets of data collection fields (CDASH). CONCLUSIONS: The essential tasks for medical informatics within the next ten years will now be the development and implementation of encompassing IT conceptions, strong support of the open community and open source approach, the acceptance of eSource in clinical research, the uncompromising continuity of standardization and bridging of technical standards and the widespread use of electronic health record systems.

[Minimum hospital volumes for total knee replacement]. / Mindestmengen bei Knie-TEP-Implantationen.

BACKGROUND: As requested by the Federal Joint Committee, the German Hospital Institute and the Heinrich-Heine University of Düsseldorf carried out an investigation of the minimum volume regulation for hospitals based on the Social Legislation Code. Total knee replacement forms one minimum volume field. Since 2006 hospitals with a performance rate of less than the minimum volume of 50 patients a year with knee replacement are no longer permitted to conduct this procedure. The object of the present analysis is to investigate the impact of the minimum volume regulation for total knee replacement. METHODS: The results are based on two hospital surveys on the application of the minimum volume regulation for total knee replacement. 279 hospitals (response rate: 41,8%) participated in 2006 and 297 hospitals in 2007 (response rate: 47,5%). The results are representative of General hospitals with total knee replacements. RESULTS: As expected, hospitals above and below the minimum volume cut-off differ in size. To date the minimum volume regulation has led to a rather selective exclusion of hospitals from care. In the case of total knee replacement 13,7% of the hospitals have been excluded. Most hospitals that do not reach the minimum volume are still participating in care. A decisive reason for this is the existence of exception rules. In hospitals exceeding the minimum volume, certain quality management tools for knee replacement are more widely spread than in hospitals that do not reach the minimum volume. As a consequence of the minimum volume regulation, the participating hospitals improved their position in the market. Vice versa, the excluded hospitals are more concerned about the damage to their image that may result from being excluded from care. With respect to the further development of the minimum volume regulation, the hospitals do not share the same point of view. DISCUSSION: Because, as yet, only few hospitals with low case numbers have been excluded from care, the immediate effects of the minimum volume regulation on the affected hospitals and hospital care in general are limited. The surveys showed a considerable uncertainty among all participants about the application and effects of the minimum volume regulation in hospitals.