PubMed Health⌕ Search

Biomedical subjects

Gunver S Kienle

Publications and source records attributed to Gunver S Kienle.

7 recordsLinked to original sources
PubMed2006

Checklist for the qualitative evaluation of clinical studies with particular focus on external validity and model validity.

BACKGROUND: It is often stated that external validity is not sufficiently considered in the assessment of clinical studies. Although tools for its evaluation have been established, there is a lack of awareness of their significance and application. In this article, a comprehensive checklist is presented addressing these relevant criteria. METHODS: The checklist was developed by listing the most commonly used assessment criteria for clinical studies. Additionally, specific lists for individual applications were included. The categories of biases of internal validity (selection, performance, attrition and detection bias) correspond to structural, treatment-related and observational differences between the test and control groups. Analogously, we have extended these categories to address external validity and model validity, regarding similarity between the study population/conditions and the general population/conditions related to structure, treatment and observation. RESULTS: A checklist is presented, in which the evaluation criteria concerning external validity and model validity are systemized and transformed into a questionnaire format. CONCLUSION: The checklist presented in this article can be applied to both planning and evaluating of clinical studies. We encourage the prospective user to modify the checklists according to the respective application and research question. The higher expenditure needed for the evaluation of clinical studies in systematic reviews is justified, particularly in the light of the influential nature of their conclusions on therapeutic decisions and the creation of clinical guidelines.

Bias↗
PubMed2006

[Anthroposophic medicine: health technology assessment report - short version].

BACKGROUND AND OBJECTIVE: The aim of this Health Technology Assessment Report was to analyse the current situation, efficacy, effectiveness, safety, utilization, and costs of Anthroposophic Medicine (AM) with special emphasis on everyday practice. DESIGN: Systematic review. MATERIAL AND METHODS: Search of 20 databases, reference lists and expert consultations. Criteriabased analysis was performed to assess methodological quality and external validity of the studies. RESULTS: AM is a complementary medical system that extends conventional medicine and provides specific pharmacological and non-pharmacological treatments. It covers all areas of medicine. 178 clinical trials on efficacy and effectiveness were identified: 17 RCTs, 21 prospective and 43 retrospective NRCTs, 50 prospective and 47 retrospective cohort studies/case-series without control groups. They investigated a wide range of AM-treatments in a variety of diseases, 90 x mistletoe in cancer. 170 trials had a positive result for AM. Methodological quality differed substantially; some studies showed major limitations, others were reasonably well conducted. Trials of better quality still showed a positive result. External validity was usually high. Side effects or other risks are rare. AM-patients are well educated, often female, aged 30-50 years, or children. The few economic investigations found less or equal costs in AM because of reduced hospital admissions and less prescriptions of medications. CONCLUSION: Trials of varying design and quality in a variety of diseases predominantly describe good clinical outcome for AM, little side effects, high satisfaction of patients and presumably slightly less costs. More research and more methodological expertise and infrastructure are desirable.

Adult↗
PubMed2005

[Is there a rationale for pluralistic evaluation models? Limitations of randomized clinical trials].

Randomized clinical trials (RCTs) are believed to deliver the highest level of clinical evidence, and other types of evidence are rarely integrated in therapy assessments. Under ideal circumstances, RCTs are perfect tools of therapy evaluation; however, in clinical reality they suffer from a variety of limitations. Their prioritization can distort public health regulation because of commercial bias, career bias, bias of large numbers, mediocrity bias, and bias of therapy preferences; also, they can lead to discrepancies between clinical research and routine medical practice, to ethical problems, and to divergent and asymmetrical results. Moreover, the seemingly simple therapy assessment based on RCT results bears the danger of their endorsement and misuse by non-medical personnel, especially bureaucrats. To meet the demands of the complex reality of medical care, the physician's judgment should be methodologically professionalized and re-integrated into the process of generating medical knowledge; fixed hierarchies of medical evidence should be de-emphasized in favor of information syntheses from different types of (quality assessed) evidence.

Clinical Medicine↗