7 results on '"Kramer L"'
Search Results
2. Health-related quality of life (HRQoL) in German early benefit assessment: The importance of disease-specific instruments.
- Author
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Kramer L, Moos M, Thaa B, Welte R, and Esser M
- Subjects
- Germany, Humans, National Health Programs, Surveys and Questionnaires, Quality of Life
- Abstract
Introduction: Health-Related Quality of Life (HRQoL) data is frequently requested in early benefit assessment in Germany. To test the hypothesis that the importance of HRQoL in general and the significance of disease-specific instruments in particular has increased since the introduction of AMNOG in Germany, we analysed all early benefit assessments between 2011 and 2022., Methods: All 793 early benefit assessments completed between 01/01/2011 and 03/11/2022 were systematically analysed. The HRQoL instruments featured in the dossier submissions were extracted for all assessments and categorized into generic and specific instruments. All G-BA resolutions were likewise assessed for consideration and acceptance of generic and specific HRQoL instruments. In addition, it was examined whether there was an association between HRQoL data and the extent of additional benefit., Results: Since 2014 HRQoL data have continuously been submitted in 70% to 80% of assessments per year with the exception of 2022 (63%). Generally, disease-specific instruments are favoured, regarding submissions by industry but especially with higher acceptance by the G-BA in the resolution. Subgroup analyses revealed oncology as a major contributor to the submission and acceptance rates of disease-specific instruments. Disease-specific instruments were submitted in 81% of all oncology assessments and accepted in 53% of assessments. Overall, assessments with accepted HRQoL data tend to reach a higher overall benefit. Procedures with accepted HRQoL were most likely to receive a considerable benefit (31%), while for procedures in which HRQoL data were not accepted, a benefit was most often (65%) not proven., Discussion: Industry has followed the request for submission of specific HRQoL instruments early on. Higher submission rates of specific instruments over time which at the same time meet the methodological requirements indicate that industry has learned from early assessments. A potential reason for the high submission- and acceptance rates of specific HRQoL instruments in oncology might be the particularly high relevance of HRQoL in this indication. Possible effects of changes in legislature on the future development of submission and acceptance of HRQoL data need to be monitored., Conclusion: In Germany, HRQoL has gained a relevant position in early benefit assessment over time. Overall specific instruments are favoured, regarding submissions by industry but especially through consideration by the G-BA in the resolution. Furthermore, HRQoL data can be supportive for benefit assessments, in particular to show that advantages in morbidity and/or mortality are reflected in HRQoL and not at the expense of HRQoL., (Copyright © 2024. Published by Elsevier GmbH.)
- Published
- 2024
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3. [Fire disaster due to deflagration of a propane gas-air mixture].
- Author
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Nadjem H, Vogt S, Simon KH, Pollak S, Geisenberger D, Kramer L, Pircher R, Perdekampl MG, and Thierauf-Emberger A
- Subjects
- Air, Forensic Medicine methods, Germany, Humans, Blast Injuries pathology, Burns pathology, Explosions classification, Fires, Multiple Trauma pathology, Propane
- Abstract
On 26 Nov 2012, a serious fire occurred at Neustadt/Black Forest in which 14 persons in a sheltered workshop died and 10 other individuals were injured. The fire was caused by the unbridled escape of propane gas due to accidental disconnection of the screw fixing between a gas bottle and a catalytic heater. Deflagration of the propane gas-air mixture set the workshop facilities on fire. In spite of partly extensive burns the fatally injured victims could be rapidly identified. The results of the fire investigations at the scene and the autopsy findings are presented. Carboxyhemoglobin concentrations ranged between 8 and 56 % and signs of fire fume inhalation were present in all cases. Three victims had eardrum ruptures due to the sudden increase in air pressure during the deflagration.
- Published
- 2015
4. Development and validation of a generic questionnaire for the implementation of complex medical interventions.
- Author
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Kramer L, Hirsch O, Becker A, and Donner-Banzhoff N
- Subjects
- Adult, Age Distribution, Aged, Attitude of Health Personnel, Computer Simulation, Female, General Practitioners classification, Germany, Humans, Male, Middle Aged, Motivation, Practice Patterns, Physicians' classification, Reproducibility of Results, Sensitivity and Specificity, Sex Distribution, General Practitioners statistics & numerical data, Intention, Models, Theoretical, Practice Patterns, Physicians' statistics & numerical data, Psychometrics methods, Surveys and Questionnaires
- Abstract
Introduction: The implementation of complex medical interventions in daily practice is often fraught with difficulties. According to the iterative phase model proposed by the British Medical Research Council (MRC), the development, implementation and evaluation of complex interventions should be theory-driven. A conceptual model that seems to be a promising framework is the Theory of planned behaviour (TPB). In our study we aimed to develop and validate a generic and multifaceted questionnaire based on the TPB to detect physicians' willingness to implement complex medical interventions and the factors influencing this willingness., Methods: The questionnaire was developed according to the literature and was informed by previous qualitative research of our department. It was validated on the example of an electronic library of decision aids, arriba-lib. The sample consisted of 181 General Practitioners (GPs) who received a training regarding arriba-lib and subsequently filled in the questionnaire, assessing the TPB variables attitude, subjective norm, perceived behaviour control and intention. Follow-up assessments were conducted after two (assessing retest reliability) and eight weeks (assessing target behaviour). We performed a confirmatory factor analysis investigating the factorial structure of our questionnaire according to the TPB. Beside the calculation of the questionnaire's psychometric properties we conducted a structural equation model and an ordinal regression to predict actual behaviour regarding the installation and application of arriba-lib., Results: The postulated three factorial model (attitude, subjective norm, perceived behaviour control) of our questionnaire based on the TPB was rejected. A two factorial model with a combined factor subjective norm/perceived behaviour control was accepted. The explained variance in the ordinal regression was low (Nagelkerke's R(2)=.12). Neither attitude nor intention were able to predict the use or non-use of arriba-lib (attitude: p=.68, intention: p=.44). For the combined factor subjective norm/perceived behaviour control a significant, but small effect (p=.03) was shown., Conclusions: The TPB is not an adequate theoretical framework to guide the development of a generic questionnaire in the context of the implementation of complex interventions. To enable the successful implementation of complex medical interventions evaluators have to go through the whole development and evaluation process according to the MRC-model, without short cuts. Further, it has to be discussed if a generic instrument can be valid and useful. Regarding the TPB a publication bias regarding the theory's applicability might have to be considered.
- Published
- 2014
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- View/download PDF
5. arriba-lib: Analyses of user interactions with an electronic library of decision aids on the basis of log data.
- Author
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Hirsch O, Szabo E, Keller H, Kramer L, Krones T, and Donner-Banzhoff N
- Subjects
- Adult, Female, Germany, Humans, Male, Middle Aged, Patient Participation, Physician-Patient Relations, User-Computer Interface, Decision Making, Computer-Assisted, Information Seeking Behavior, Libraries, Digital, Medical Informatics
- Abstract
Computerised log files are important for analysing user behaviour in health informatics to gain insight into processes that lead to suboptimal user patterns. This is important for software training programmes or for changes to improve usability. Technical user behaviour regarding decision aids has not so far been thoroughly investigated with log files. The aim of our study was to examine more detailed user interactions of primary-care physicians and their patients with arriba-lib, our multimodular electronic library of decision aids used during consultations, on the basis of log data. We analysed 184 consultation log files from 28 primary-care physicians. The average consultation time of our modules was about 8 min. Two-thirds of the consultation time were spent in the history information part of the programme. In this part, mainly bar charts were used to display risk information. Our electronic library of decision aids does not generate specific user behaviour based on physician characteristics such as age, gender, years in practice, or prior experience with decision aids. This supports the widespread use of our e-library in the primary-care sector and probably beyond.
- Published
- 2012
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- View/download PDF
6. Qualitative evaluation of a local coronary heart disease treatment pathway: practical implications and theoretical framework.
- Author
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Kramer L, Schlößler K, Träger S, and Donner-Banzhoff N
- Subjects
- Adult, Aged, Clinical Competence, Computers, Handheld, Female, Germany, Group Practice statistics & numerical data, Guideline Adherence, Humans, Interviews as Topic, Male, Middle Aged, Models, Theoretical, Monitoring, Ambulatory, Physicians, Family statistics & numerical data, Private Practice statistics & numerical data, Professional Practice Location statistics & numerical data, Qualitative Research, Coronary Disease therapy, Critical Pathways, Physicians, Family psychology
- Abstract
Background: Coronary heart disease (CHD) is a common medical problem in general practice. Due to its chronic character, shared care of the patient between general practitioner (GP) and cardiologist (C) is required. In order to improve the cooperation between both medical specialists for patients with CHD, a local treatment pathway was developed. The objective of this study was first to evaluate GPs' opinions regarding the pathway and its practical implications, and secondly to suggest a theoretical framework of the findings by feeding the identified key factors influencing the pathway implementation into a multi-dimensional model., Methods: The evaluation of the pathway was conducted in a qualitative design on a sample of 12 pathway developers (8 GPs and 4 cardiologists) and 4 pathway users (GPs). Face-to face interviews, which were aligned with previously conducted studies of the department and assumptions of the theory of planned behaviour (TPB), were performed following a semi-structured interview guideline. These were audio-taped, transcribed verbatim, coded, and analyzed according to the standards of qualitative content analysis., Results: We identified 10 frequently mentioned key factors having an impact on the implementation success of the CHD treatment pathway. We thereby differentiated between pathway related (pathway content, effort, individual flexibility, ownership), behaviour related (previous behaviour, support), interaction related (patient, shared care/colleagues), and system related factors (context, health care system). The overall evaluation of the CHD pathway was positive, but did not automatically lead to a change of clinical behaviour as some GPs felt to have already acted as the pathway recommends., Conclusions: By providing an account of our experience creating and implementing an intersectoral care pathway for CHD, this study contributes to our knowledge of factors that may influence physicians' decisions regarding the use of a local treatment pathway. An improved adaptation of the pathway in daily practice might be best achieved by a combined implementation strategy addressing internal and external factors. A simple, direct adaptation regards the design of the pathway material (e.g. layout, PC version), or the embedding of the pathway in another programme, like a Disease Management Programme (DMP). In addition to these practical implications, we propose a theoretical framework to understand the key factors' influence on the pathway implementation, with the identified factors along the microlevel (pathway related factors), the mesolevel (interaction related factors), and system- related factors along the macrolevel.
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- 2012
- Full Text
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7. Do guidelines on first impression make sense? Implementation of a chest pain guideline in primary care: a systematic evaluation of acceptance and feasibility.
- Author
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Kramer L, Rabanizada N, Haasenritter J, Bösner S, Baum E, and Donner-Banzhoff N
- Subjects
- Adult, Chest Pain therapy, Clinical Protocols, Cross-Sectional Studies, Feedback, Female, General Practitioners education, Germany, Humans, Male, Middle Aged, Pain Measurement, Patient Participation psychology, Patient Participation statistics & numerical data, Referral and Consultation organization & administration, Rural Population, Surveys and Questionnaires, Urban Population, Chest Pain diagnosis, Clinical Competence, General Practitioners psychology, Guideline Adherence, Health Plan Implementation, Practice Guidelines as Topic, Primary Health Care standards
- Abstract
Background: Most guidelines concentrate on investigations, treatment, and monitoring instead of patient history and clinical examination. We developed a guideline that dealt with the different aetiologies of chest pain by emphasizing the patient's history and physical signs. The objective of this study was to evaluate the guideline's acceptance and feasibility in the context of a practice test., Methods: The evaluation study was nested in a diagnostic cross-sectional study with 56 General Practitioners (GPs) and 862 consecutively recruited patients with chest pain. The evaluation of the guideline was conducted in a mixed method design on a sub-sample of 17 GPs and 282 patients. Physicians' evaluation of the guideline was assessed via standardized questionnaires and case record forms. Additionally, practice nursing staff and selected patients were asked for their evaluation of specific guideline modules. Quantitative data was analyzed descriptively for frequencies, means, and standard deviations. In addition, two focus groups with a total of 10 GPs were held to gain further insights in the guideline implementation process. The data analysis and interpretation followed the standards of the qualitative content analysis., Results: The overall evaluation of the GPs participating in the evaluation study regarding the recommendations made in the chest pain guideline was positive. A total of 14 GPs were convinced that there was a need for this kind of guideline and perceived the guideline recommendations as useful. While the long version was partially criticized for a perceived lack of clarity, the short version of the chest pain guideline and the heart score were especially appreciated by the GPs. However, change of clinical behaviour as consequence of the guideline was inconsistent. While on a concrete patient related level, GPs indicated to have behaved as the guideline recommended, the feedback on a more general level was heterogeneous. Several suggestions to improve guideline implementation were made by participating physicians. Due to the small number of practice nursing staff evaluating the flowchart and patients remembering the patient leaflet, no valid results regarding the flowchart and patient leaflet modules could be reported., Conclusions: Overall, the participating GPs perceived the guideline recommendations as useful to increase awareness and to reflect on diagnostic issues. Although behaviour change in consequence of the guideline was not reported on a general level, guidelines on history taking and the clinical examination may serve an important conservative and practical function in a technology driven environment. Further research to increase the implementation success of the guideline should be undertaken.
- Published
- 2011
- Full Text
- View/download PDF
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