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1.
Support Care Cancer ; 32(1): 53, 2023 Dec 22.
Article in English | MEDLINE | ID: mdl-38129530

ABSTRACT

PURPOSE: Our goal was to identify new anticancer agents approved by the US Food and Drug Administration (FDA) and the European Medical Agency (EMA) since the 2016 MASCC/ESMO antiemetic update and classify their emetic potential. METHODS: The MASCC/ESMO Expert Panel classified the emetogenicity of the identified new antineoplastic agents based on nonsystematic reviews of randomized controlled trials, analysis of product labeling, and evaluation of emetic classification in other international guidelines and informal consensus. The emetogenic classification system for oral anticancer agents was revised into two emetic risk categories (minimal-low; moderate-high) to be consistent with the system reported by ASCO (American Society of Clinical Oncology) in their 2017 guideline update. The previously employed four emetic risk classification categories for intravenously administered antineoplastic agents were retained for this update. RESULTS: From June 2015 to January 2023, 107 new antineoplastic agents (44 intravenously administered and 63 orally administered agents) were identified. The reported incidence of vomiting varied significantly across studies for many agents, especially for oral anticancer agents. CONCLUSION: The MASCC/ESMO Expert Panel acknowledges the limitations of our efforts to classify the emetic potential of anticancer agents, especially the imprecision associated with oral agents. However, we have attempted to provide a reasonable approximation of the emetic risk associated with new antineoplastic agents by searching the available literature and reviewing other available international antiemetic guidelines.


Subject(s)
Antiemetics , Antineoplastic Agents , Humans , Antiemetics/therapeutic use , Antineoplastic Agents/adverse effects , Consensus , Emetics/therapeutic use , Nausea/chemically induced , Nausea/prevention & control , Nausea/drug therapy , Vomiting/chemically induced , Vomiting/prevention & control , Randomized Controlled Trials as Topic
2.
Support Care Cancer ; 32(1): 37, 2023 Dec 19.
Article in English | MEDLINE | ID: mdl-38110581

ABSTRACT

PURPOSE: Review the literature to update the MASCC guidelines from 2016 for controlling nausea and vomiting with systemic cancer treatment of low and minimal emetic potential. METHODS: A working group performed a systematic literature review using Medline, Embase, and Scopus databases between June 2015 and January 2023 of the management of antiemetic prophylaxis for anticancer therapy of low or minimal emetic potential. A consensus committee reviewed recommendations and required a consensus of 67% or greater and a change in outcome of at least 10%. RESULTS: Of 293 papers identified, 15 had information about managing systemic cancer treatment regimens of low or minimal emetic potential and/or compliance with previous management recommendations. No new evidence was reported that would change the current MASCC recommendations. No antiemetic prophylaxis is recommended for minimal emetic potential therapy, and single agents recommended for low emetic potential chemotherapy for acute emesis, but no prophylaxis is recommended for delayed emesis. Commonly, rescue medication includes antiemetics prescribed for the next higher level of emesis. CONCLUSION: There is insufficient data to change the current guidelines. Future studies should seek to more accurately determine the risk of emesis with LEC beyond the emetogenicity of the chemotherapy to include patient-related risk assessment.


Subject(s)
Antiemetics , Antineoplastic Agents , Humans , Antiemetics/therapeutic use , Antineoplastic Agents/adverse effects , Consensus , Emetics , Nausea/chemically induced , Nausea/prevention & control , Nausea/drug therapy , Vomiting/chemically induced , Vomiting/drug therapy , Vomiting/prevention & control , Systematic Reviews as Topic , Practice Guidelines as Topic
3.
Support Care Cancer ; 32(1): 26, 2023 Dec 15.
Article in English | MEDLINE | ID: mdl-38097904

ABSTRACT

PURPOSE: Radiotherapy and chemoradiotherapy-induced nausea and vomiting (RINV and C-RINV) are common and distressing, and there is a need for guidance for clinicians to provide up to date optimal antiemetic prophylaxis and treatment. Through a comprehensive review of the literature concerning RINV and C-RINV, this manuscript aims to update the evidence for antiemetic prophylaxis and rescue therapy and provide a new edition of recommendations for the MASCC/ESMO antiemetic guidelines for RINV and C-RINV. METHODS: A systematic review of the literature including data published from May 1, 2015, to January 31, 2023, was performed. All authors assessed the literature. RESULTS: The searches yielded 343 references; 37 met criteria for full article review, and 20 were ultimately retained. Only one randomized study in chemoradiation had the impact to provide new recommendations for the antiemetic guideline. Based on expert consensus, it was decided to change the recommendation for the "low emetic risk" category from "prophylaxis or rescue" to "rescue" only, while the drugs of choice remain unchanged. CONCLUSION: As for the previous guideline, the serotonin receptor antagonists are still the cornerstone in antiemetic prophylaxis of nausea and vomiting induced by high and moderate emetic risk radiotherapy. The guideline update provides new recommendation for the management of C-RINV for radiotherapy and concomitant weekly cisplatin. To avoid overtreatment, antiemetic prophylaxis is no longer recommended for the "low emetic risk" category.


Subject(s)
Antiemetics , Antineoplastic Agents , Humans , Emetics/adverse effects , Consensus , Vomiting/chemically induced , Vomiting/prevention & control , Nausea/chemically induced , Nausea/prevention & control , Chemoradiotherapy/adverse effects , Radiotherapy , Antineoplastic Agents/adverse effects
4.
JMIR Med Inform ; 11: e38861, 2023 Jan 20.
Article in English | MEDLINE | ID: mdl-36662569

ABSTRACT

BACKGROUND: There is a variety of libre/free and open-source software (LIFOSS) products for medicine and health care. To support health care and IT professionals select an appropriate software product for given tasks, several comparison studies and web platforms, such as Medfloss.org, are available. However, due to the lack of a uniform terminology for health informatics, ambiguous or imprecise terms are used to describe the functionalities of LIFOSS. This makes comparisons of LIFOSS difficult and may lead to inappropriate software selection decisions. Using Linked Open Data (LOD) promises to address these challenges. OBJECTIVE: We describe LIFOSS systematically with the help of the underlying Health Information Technology Ontology (HITO). We publish HITO and HITO-based software product descriptions using LOD to obtain the following benefits: (1) linking and reusing existing terminologies and (2) using Semantic Web tools for viewing and querying the LIFOSS data on the World Wide Web. METHODS: HITO was incrementally developed and implemented. First, classes for the description of software products in health IT evaluation studies were identified. Second, requirements for describing LIFOSS were elicited by interviewing domain experts. Third, to describe domain-specific functionalities of software products, existing catalogues of features and enterprise functions were analyzed and integrated into the HITO knowledge base. As a proof of concept, HITO was used to describe 25 LIFOSS products. RESULTS: HITO provides a defined set of classes and their relationships to describe LIFOSS in medicine and health care. With the help of linked or integrated catalogues for languages, programming languages, licenses, features, and enterprise functions, the functionalities of LIFOSS can be precisely described and compared. We publish HITO and the LIFOSS descriptions as LOD; they can be queried and viewed using different Semantic Web tools, such as Resource Description Framework (RDF) browsers, SPARQL Protocol and RDF Query Language (SPARQL) queries, and faceted searches. The advantages of providing HITO as LOD are demonstrated by practical examples. CONCLUSIONS: HITO is a building block to achieving unambiguous communication among health IT professionals and researchers. Providing LIFOSS product information as LOD enables barrier-free and easy access to data that are often hidden in user manuals of software products or are not available at all. Efforts to establish a unique terminology of medical and health informatics should be further supported and continued.

5.
Stud Health Technol Inform ; 294: 790-795, 2022 May 25.
Article in English | MEDLINE | ID: mdl-35612205

ABSTRACT

SNIK is a knowledge base about the management of health information systems generated by extracting Linked Data from textbooks and other sources. SNIK describes functions, roles executing these functions, and entity types, the information used or updated by these functions. We present SNIK Quiz, a browser game in which students answer multiple-choice questions about information management in hospitals based on SNIK. The questions are semi-automatically generated using templates in order to train basic facts, more complex patterns, and connections between textbooks encoded in SNIK.


Subject(s)
Health Information Systems , Information Management , Hospitals , Humans , Information Management/education , Semantic Web , Students
6.
Dtsch Arztebl Int ; 119(21): 382-392, 2022 05 27.
Article in English | MEDLINE | ID: mdl-35140010

ABSTRACT

BACKGROUND: Nausea and vomiting are common and distressing side effects of tumor therapy. Despite prophylaxis, 40-50% of patients suffer from nausea, and 20-30% from vomiting. Antiemetic prophylaxis and treatment are therefore of great importance for improving patients' quality of life and preventing sequelae such as tumor cachexia. METHODS: The recommendations presented here are based on international and national guidelines, updated with publications retrieved by a selective search in the PubMed and Cochrane Library databases, with special attention to randomized controlled trials and meta-analyses that have appeared in the past 5 years since the German clinical practice guideline on supportive therapy was published. RESULTS: Risk-adjusted prevention and treatment is based on the identification of treatment-related and patient-specific risk factors, including female sex and younger age. Parenteral tumor therapy is divided into four risk classes (minimal, low, moderate, high), and oral tumor therapy into two (minimal/low, moderate/high). In radiotherapy, the radiation field is of decisive importance. The antiemetic drugs most commonly used are 5-HT3-RA, NK1-RA, and dexamethasone; olanzapine has proven beneficial as an add-on or rescue drug. The use of steroids in patients being treated with drug combinations including checkpoint inhibitors is discussed controversially because of the potentially reduced therapeutic response. Benzodiazepines, dimenhydrinate, and cannabinoids can be used as backup antiemetics. Acupuncture/acupressure, ginger, and progressive muscle relaxation are pos - sible alternative methods. CONCLUSION: Detailed, effective, risk profile-adapted algorithms for the prevention and treatment of nausea and vomiting are now available for patients undergoing classic chemotherapy regimens or combined radiotherapy and chemotherapy. Optimal symptom control for patients undergoing oral tumor therapy over multiple days in the outpatient setting remains a challenge.


Subject(s)
Antiemetics , Antineoplastic Agents , Mouth Neoplasms , Antiemetics/adverse effects , Antiemetics/therapeutic use , Antineoplastic Agents/adverse effects , Female , Humans , Mouth Neoplasms/chemically induced , Mouth Neoplasms/complications , Mouth Neoplasms/drug therapy , Nausea/etiology , Nausea/prevention & control , Quality of Life , Vomiting/etiology , Vomiting/prevention & control
7.
Eur J Dent Educ ; 25(3): 435-441, 2021 Aug.
Article in English | MEDLINE | ID: mdl-33053252

ABSTRACT

INTRODUCTION: Competencies in the clinical examination of patients with temporomandibular disorders (TMD) can be achieved by self-instruction. This study aimed to identify the impact of the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) instructional video on the practical examination skills of undergraduate students. MATERIALS AND METHODS: One week prior to completing an objective structured clinical examination (OSCE) addressing the examination of patients with TMD, undergraduate students in their third year received either the DC/TMD manual (control group) or additionally watched the instructional video once (intervention group). After passing the OSCE, a feedback questionnaire was completed by the students. RESULT: Fifty undergraduates were recruited to take part in the OSCE prior to their first clinical course. The sum scores achieved in the stations were higher in the intervention group, but missed significance. Participants of the intervention group more often agreed that completing the OSCE stations was easy, which was significant for one station (P = .023). 95.8% of the participating students supported the implementation of the video in dental education. DISCUSSION: Due to the conception of the study, the video was only presented once to ensure that the control group had no access to the medium at all. However, it might be interesting to investigate whether repeated watching of the video enhances its effect. CONCLUSIONS: Clinical competencies in the examination of TMD patients can be achieved by self-instruction with the DC/TMD manual and instructional video. Watching the video for educational purposes was highly recommended by undergraduate students.


Subject(s)
Education, Medical, Undergraduate , Temporomandibular Joint Disorders , Clinical Competence , Education, Dental , Educational Measurement , Humans , Physical Examination , Students
8.
Stud Health Technol Inform ; 272: 95-98, 2020 Jun 26.
Article in English | MEDLINE | ID: mdl-32604609

ABSTRACT

Having precise information about health IT evaluation studies is important for evidence-based decisions in medical informatics. In a former feasibility study, we used a faceted search based on ontological modeling of key elements of studies to retrieve precisely described health IT evaluation studies. However, extracting the key elements manually for the modeling of the ontology was time and resource-intensive. We now aimed at applying natural language processing to substitute manual data extraction by automatic data extraction. Four methods (Named Entity Recognition, Bag-of-Words, Term-Frequency-Inverse-Document-Frequency, and Latent Dirichlet Allocation Topic Modeling were applied to 24 health IT evaluation studies. We evaluated which of these methods was best suited for extracting key elements of each study. As gold standard, we used results from manual extraction. As a result, Named Entity Recognition is promising but needs to be adapted to the existing study context. After the adaption, key elements of studies could be collected in a more feasible, time- and resource-saving way.


Subject(s)
Natural Language Processing , Information Storage and Retrieval
9.
Methods Inf Med ; 59(S 01): e1-e12, 2020 06.
Article in English | MEDLINE | ID: mdl-32620017

ABSTRACT

BACKGROUND: Against the background of a steadily increasing degree of digitalization in health care, a professional information management (IM) is required to successfully plan, implement, and evaluate information technology (IT). At its core, IM has to ensure a high quality of health data and health information systems to support patient care. OBJECTIVES: The goal of the present study was to define what constitutes professional IM as a construct as well as to propose a reliable and valid measurement instrument. METHODS: To develop and validate the construct of professionalism of information management (PIM) and its measurement, a stepwise approach followed an established procedure from information systems and behavioral research. The procedure included an analysis of the pertaining literature and expert rounds on the construct and the instrument, two consecutive and comprehensive surveys at the national and international level, exploratory and confirmatory factor analyses as well as reliability and validity testing. RESULTS: Professionalism of information management was developed as a construct consisting of the three dimensions of strategic, tactical, and operational IM as well as of the regularity and cyclical phases of IM procedures as the two elements of professionalism. The PIM instrument operationalized the construct providing items that incorporated IM procedures along the three dimensions and cyclical phases. These procedures had to be evaluated against their degree of regularity in the instrument. The instrument proved to be reliable and valid in two consecutive measurement phases and across three countries. CONCLUSION: It can be concluded that professionalism of information management is a meaningful construct that can be operationalized in a scientifically rigorous manner. Both science and practice can benefit from these developments in terms of improved self-assessment, benchmarking capabilities, and eventually, obtaining a better understanding of health IT maturity.


Subject(s)
Benchmarking , Delivery of Health Care , Information Management , Professionalism/standards , Concept Formation , Medical Informatics , Reproducibility of Results
10.
Stud Health Technol Inform ; 270: 463-468, 2020 Jun 16.
Article in English | MEDLINE | ID: mdl-32570427

ABSTRACT

The web portal Medfloss.org lists over 360 medical free/libre and open source software (MEDFLOSS) projects. These projects are described with the help of a self-developed nomenclature. Due to inconsistencies, the nomenclature shall be replaced by HITO, the Health IT Ontology. HITO is developed iteratively based on different use cases. This paper aims to describe methods and results of the second HITO use case in which HITO is extended to improve the description, retrieval and comparisons of MEDFLOSS projects on Medfloss.org. We use a mixed-methods approach to add concepts and relationships to describe MEDFLOSS precisely. The resulting HITO version stresses functional descriptions based on features and supported enterprise functions, rather than just describing technical characteristics. However, describing a larger number of MEDFLOSS projects requires the commitment of the community.


Subject(s)
Software , Semantics
11.
Breast Care (Basel) ; 14(2): 79-84, 2019 Apr.
Article in English | MEDLINE | ID: mdl-31798378

ABSTRACT

Chemotherapy-induced peripheral neurotoxicity (CIPN) is a severe and common side effect caused by a variety of antineoplastic agents. Approximately 30-40% of patients treated with agents such as taxanes, vinca alkaloids, or platinum derivatives will develop CIPN. CIPN presents predominantly as a sensory axonal neuro(no)pathy with occasional motor and autonomic dysfunction exhibiting considerable variability of clinical symptoms ranging from mild tingling sensation to severe neuropathic pain. Typical symptoms include numbness ("minus symptom"), weakness, and abnormal gait as well as paresthesia and pain ("positive symptoms"). As CIPN symptoms potentially lead to long-term morbidity and can even aggravate after cessation of therapy, patients' quality of life can be tremendously affected. In view of improved breast cancer survival outcomes, the late effects of CIPN are an unmet need in these patients. Therefore, early detection and assessment of first symptoms is important to effectively prevent severe CIPN. Therapeutic options for patients with CIPN are still limited, and pharmacological treatment focuses primarily on reduction or relief of neuropathic pain. CIPN is usually acutely managed by dose reduction or discontinuation of causative chemotherapy, potentially compromising treatment outcome. Currently, there is no causative proven therapy for the prevention of CIPN.

12.
Stud Health Technol Inform ; 264: 1419-1420, 2019 Aug 21.
Article in English | MEDLINE | ID: mdl-31438160

ABSTRACT

Health informatics as a young, interdisciplinary discipline lacks a unified terminology in some areas. This is especially true when trying to properly describe health informatics interventions developed and deployed to improve quality and efficiency of patient care. We aim at developing a health IT ontology which allows systematically describing health IT interventions. To achieve this, we combine a deductive and an inductive approach. First results are promising and may later be extended by a folksonomy.


Subject(s)
Medical Informatics , Humans , Patient Care
13.
Stud Health Technol Inform ; 264: 1678-1679, 2019 Aug 21.
Article in English | MEDLINE | ID: mdl-31438289

ABSTRACT

Given a care delivery organization, its health information system can be defined as the part of the organization that processes and stores data, information, and knowledge. There is an enormous number of frameworks, textbooks and articles that describe the scope of health information system management from the perspective of medical informatics. Transforming this knowledge to Linked Open Data results in a structured data representation that is accessible for both humans and machines, the Semantic Network of Information Management in Hospitals (SNIK). We present interfaces that are useful for researchers, practitioners and students, depending on their objectives and their Semantic Web skills.


Subject(s)
Health Information Systems , Medical Informatics , Semantic Web , Humans , Information Management , Knowledge Management
14.
Stud Health Technol Inform ; 264: 1941-1942, 2019 Aug 21.
Article in English | MEDLINE | ID: mdl-31438418

ABSTRACT

SNIK, a medical informatics ontology, combines knowledge from different literature sources dealing with the management of hospital information systems (HIS). Concepts and relations were extracted from literature, modeled as an ontology and visualized as a graph on a website. We demonstrate the potential of the graph visualization for tuitional scenarios. SNIK complements teaching and learning with conventional literature by concentrating knowledge that is scattered over different pieces of text around one node of a graph.


Subject(s)
Hospital Information Systems , Medical Informatics , Knowledge , Semantics
15.
Z Kinder Jugendpsychiatr Psychother ; 47(3): 239-251, 2019 May.
Article in English | MEDLINE | ID: mdl-30080118

ABSTRACT

Objective: Secure attachment style is a known protective factor regarding psychopathological development. The infant's attachment style, which is developed during the first two years of life, is therefore considered a moderating factor on the association between prenatal maternal distress and child temperament development which has repeatedly been reported in previous studies. Method: In this longitudinal study on a new sample of 51 mother-child-dyads, reported maternal distress and maternal empathy were assessed during pregnancy. Infant temperament and motor development were assessed at 12 months, while additionally controlling for the infant's attachment style as a postnatal factor. Results: Infants with secure attachment style whose mothers had experienced higher prenatal distress showed slightly better gross motor development at the age of 12 months. No association could be found between prenatal maternal distress and infant temperament. Conclusions: The results support the view that secure attachment style in children is a protective factor and softens the effects of prenatal maternal distress on difficult temperament development.


Subject(s)
Child Development , Mother-Child Relations/psychology , Mothers/psychology , Object Attachment , Pregnancy/psychology , Temperament , Child , Empathy , Female , Humans , Infant , Longitudinal Studies
16.
Stud Health Technol Inform ; 247: 800-804, 2018.
Article in English | MEDLINE | ID: mdl-29678071

ABSTRACT

Current frameworks postulate the success of health IT innovations to be determined by the professionalism of the information management (PIM). Still, empirical knowledge about PIM is scarce up until today. This study seeks to answer three research questions: (1.) How can PIM be measured in a reliable and valid way, (2.) how pronounced is PIM in German hospitals and (3.) do hospital characteristics have an impact on the degree of PIM? Based on the results of an expert workshop and frameworks for information management (IM) items for a PIM inventory were developed and the inventory sent to 1349 chief information officers of German hospitals. A principle component analysis based on the responses of 196 hospitals confirmed the three components that had been proposed by the frameworks: the strategic, the tactical and the operational level. The full inventory implied satisfying reliability and allowed a PIM composite-score to be calculated. The PIM scores for strategic and tactical IM were found to be far lower than for operational IM which hints at strong deficits in these areas. A stepwise regression model indicated that the degree of PIM significantly increased with the size of the hospital, which had been expected and hints the validity of the PIM inventory. This tool offers potentials for hospitals to classify and improve their IM.


Subject(s)
Hospitals , Information Management , Professionalism , Humans , Reproducibility of Results , Surveys and Questionnaires
17.
Support Care Cancer ; 26(1): 21-32, 2018 01.
Article in English | MEDLINE | ID: mdl-28861627

ABSTRACT

PURPOSE: This systematic review evaluates the efficacy of neurokinin-1 receptor antagonists (NK1RAs) for the prevention of chemotherapy-induced nausea and vomiting (CINV) in moderately emetogenic chemotherapy (MEC) excluding anthracycline-cyclophosphamide-based regimens. METHODS: A systematic review of MEDLINE (via PubMed and OVID) and Central databases, plus major oncology conferences, identified randomized trials evaluating NK1RAs in combination with a 5-HT3 RA plus a glucocorticoid for management of CINV. Efficacy endpoints were complete response (CR), no emesis and no nausea rates. Data were analyzed using a random effects model. RESULTS: Sixteen trials (3848 patients) were identified. Results were separately analyzed for (a) pure MEC regimens (excluding regimens containing carboplatin or oxaliplatin), (b) carboplatin-based regimens, and (c) oxaliplatin-based regimens. (a) Two trials (abstracts) enrolled 715 patients. The odds ratio for overall CR with the addition of an NK1-RA was 1.46 (95% 1.06-2.02; p = 0.02) with an absolute risk difference (RD) of 8%. (b) Nine trials (1790 patients) were identified. The OR for achieving an overall CR was 1.96 (95% CI 1.57-2.45; p < 0.00001) in favor of the NK1RA containing regimen with an RD of 15%. (c) Three trials (1190 patients) were identified. The OR for achieving an overall CR was 1.34 (95% CI 0.88-2.04; p = 0.17) not reaching statistical significance with a RD of 4%. CONCLUSION: Clear clinically significant benefit was seen with the addition of NK1RAs in carboplatin-based chemotherapy. A global benefit of an NK1RA containing regimen for the whole MEC category cannot be attested yet and warrants more randomized trials exclusively testing pure MEC regimens without carboplatin.


Subject(s)
Antiemetics/therapeutic use , Induction Chemotherapy/methods , Nausea/drug therapy , Neurokinin-1 Receptor Antagonists/therapeutic use , Vomiting/drug therapy , Antiemetics/pharmacology , Humans , Nausea/chemically induced , Neurokinin-1 Receptor Antagonists/pharmacology , Vomiting/chemically induced
18.
Cochrane Database Syst Rev ; 12: CD006250, 2017 12 26.
Article in English | MEDLINE | ID: mdl-29278410

ABSTRACT

BACKGROUND: The prevalence and incidence of pain and skeletal complications of metastatic bone disease such as pathologic fractures, spinal cord compression and hypercalcemia is high and an important contributor to morbidity, poor performance status and decreased quality of life. Moreover, pathologic fractures are associated with increased risk of death in people with disseminated malignancies. Therefore, prevention of pain and fractures are important goals in men with prostate cancer at risk for skeletal complications. OBJECTIVES: To assess the effects of bisphosphonates in men with bone metastases from prostate cancer. SEARCH METHODS: We identified studies by electronic search of bibliographic databases including the Cochrane Controlled Trials Register and MEDLINE on 13 July 2017 and trial registries. We handsearched the Proceedings of American Society of Clinical Oncology (to July 2017) and reference lists of all eligible trials identified. This is an update of a review last published in 2006. SELECTION CRITERIA: We included randomized controlled studies comparing the effectiveness of bisphosphonates in men with bone metastases from prostate cancer. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the quality of trials. We defined the proportion of participants with pain response as the primary end point; secondary outcomes were skeletal-related events, mortality, quality of life, adverse events, analgesic consumption and disease progression. We assessed the quality of the evidence for the main outcomes using the GRADE approach. MAIN RESULTS: We included 18 trials reporting on 4843 participants comparing the effect of bisphosphonate administration to control regimens. PRIMARY OUTCOME: there was no clear difference in the proportion of participants with pain response (RR 1.15, 95% CI 0.93 to 1.43; P = 0.20; I2 = 0%; 3 trials; 876 participants; low quality evidence). In absolute terms, bisphosphonates resulted in a pain response in 40 more participants per 1000 (19 fewer to 114 more). SECONDARY OUTCOMES: bisphosphonates probably reduced the incidence of skeletal-related events in participants with prostate cancer metastatic to bone (RR 0.87, 95% CI 0.81 to 0.94; P = 0.27; I2 = 19%; 9 trials; 3153 participants; moderate quality evidence). In absolute terms, bisphosphonates resulted in 58 fewer SREs per 1000 (85 fewer to 27 fewer).We found no clinically relevant differences in mortality (RR 0.97, 95% CI 0.91 to 1.04; P = 0.43; I2 = 1%; 9 trials; 2450 participants; moderate quality evidence). In absolute terms, bisphosphonates resulted in 16 fewer deaths per 1000 (47 fewer to 21 more).Outcome definition of quality of life and the measurement tools varied greatly across trials and we were unable to extract any quantitative data for meta-analysis.Bisphosphonates probably increased the number of participants affected by nausea (RR 1.19, 95% CI 1.00 to 1.41; P = 0.05; I2 = 0%; 9 trials; 3008 participants; moderate quality evidence). In absolute terms, bisphosphonates resulted in seven more cases of nausea per 1000 (0 fewer to 14 more). Bisphosphonates probably increased the number of renal adverse events (RR 1.65, 95% CI 1.11 to 2.46; P = 0.01; I2 = 0%; 7 trials; 1794 participants; moderate quality evidence). In absolute terms, bisphosphonates resulted in 22 more renal adverse events per 1000 (4 more to 50 more). We found no clear difference in the number of participants with osteonecrosis of the jaw between groups (RR 1.92, 95% CI 0.75 to 4.90; P = 0.17; I2 = 0%; 5 trials; 1626 participants; very low quality evidence). In absolute terms, bisphosphonates resulted in seven more cases with osteonecrosis of the jaw per 1000 (2 fewer to 29 more). We observed no clinically relevant difference in the proportion of participants with decreased analgesic consumption (RR 1.19, 95% CI 0.87 to 1.63; P = 0.28; I2 = 37%; 4 trials; 416 participants). Statistical analysis revealed that bisphosphonates probably reduced the number of participants with disease progression (RR 0.94, 95% CI 0.90 to 0.98; P = 0.006; I2 = 0%; 7 trials; 2115 participants; moderate quality evidence). In absolute terms, bisphosphonates resulted in 36 fewer cases of disease progression per 1000 (71 fewer to 7 fewer).Findings of our predefined subgroup and sensitivity analyses were no different from those of the primary analyses. AUTHORS' CONCLUSIONS: Based on low quality evidence, there may be no clinically relevant difference in the proportion of men with pain response between bisphosphonates and control regimens in men with bone metastases from prostate cancer. Bisphosphonates probably decrease the number of skeletal-related events and disease progression. These benefits need to be weighed against the increased risk of renal impairment and nausea in men receiving bisphosphonates. Future studies should explicitly evaluate patient important outcomes such as quality of life and pain by using standardized and comparable assessment tools.


Subject(s)
Bone Density Conservation Agents/therapeutic use , Bone Neoplasms/drug therapy , Bone Neoplasms/secondary , Diphosphonates/therapeutic use , Pain/drug therapy , Prostatic Neoplasms , Bisphosphonate-Associated Osteonecrosis of the Jaw/epidemiology , Bone Density Conservation Agents/adverse effects , Bone Neoplasms/mortality , Diphosphonates/adverse effects , Humans , Kidney/drug effects , Male , Nausea/chemically induced , Pain/etiology , Randomized Controlled Trials as Topic
19.
Methods Inf Med ; 56(7): e92-e104, 2017 Aug 07.
Article in English | MEDLINE | ID: mdl-28925415

ABSTRACT

BACKGROUND: For more than 30 years, there has been close cooperation between Japanese and German scientists with regard to information systems in health care. Collaboration has been formalized by an agreement between the respective scientific associations. Following this agreement, two joint workshops took place to explore the similarities and differences of electronic health record systems (EHRS) against the background of the two national healthcare systems that share many commonalities. OBJECTIVES: To establish a framework and requirements for the quality of EHRS that may also serve as a basis for comparing different EHRS. METHODS: Donabedian's three dimensions of quality of medical care were adapted to the outcome, process, and structural quality of EHRS and their management. These quality dimensions were proposed before the first workshop of EHRS experts and enriched during the discussions. RESULTS: The Quality Requirements Framework of EHRS (QRF-EHRS) was defined and complemented by requirements for high quality EHRS. The framework integrates three quality dimensions (outcome, process, and structural quality), three layers of information systems (processes and data, applications, and physical tools) and three dimensions of information management (strategic, tactical, and operational information management). CONCLUSIONS: Describing and comparing the quality of EHRS is in fact a multidimensional problem as given by the QRF-EHRS framework. This framework will be utilized to compare Japanese and German EHRS, notably those that were presented at the second workshop.


Subject(s)
Electronic Health Records/standards , Information Management/standards , Congresses as Topic , Electronic Health Records/economics , Germany , Humans , Japan , Software
20.
Stud Health Technol Inform ; 243: 122-126, 2017.
Article in English | MEDLINE | ID: mdl-28883184

ABSTRACT

The SNIK project converts textbooks about information management in hospitals to a domain ontology that provides a shared vocabulary for institutions to model and integrate processes, data and infrastructure. To accommodate user groups with different requirements and technical backgrounds, and to support incremental and cooperative development, we create a system architecture to publish, visualize, browse and query the ontology, as well as to evaluate and improve the data quality.


Subject(s)
Biological Ontologies , Hospital Information Systems , Vocabulary, Controlled , Humans , Information Management
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