[Methodological Standard for the Development of Quality Indicators within Clinical Practice Guidelines - Results of a structured consensus process]. / Methodischer Standard für die Entwicklung von Qualitätsindikatoren im Rahmen von S3-Leitlinien ­ Ergebnisse einer strukturierten Konsensfindung.

BACKGROUND: Recommendations of evidence- and formally consensus-based clinical practice guidelines (CPGs) represent a valuable source of quality indicators (QIs). Nevertheless, a standardized methodological procedure for developing QIs in the context of CPGs does not yet exist in Germany for all CPGs. For this reason, a methodological standard for the guideline-based development of QIs (QI Standard) was developed based on a structured consensus process involving multiple key stakeholders. METHODS: The proposed content of the QI Standard was derived from evidence, drawing upon results of reviews and qualitative studies, and considered German manuals for guideline-based QI development of two guideline programs. A multi-perspective consensus panel, broadly representing key stakeholders from the German healthcare system with expertise in CPGs and/or quality management, was nominated to vote on recommendations for guideline-based development of QIs. The iterative, structured consensus process included a two-stage online survey based on the Delphi method ("preliminary voting") and a moderated final stakeholder conference where all those recommendations were definitely included in the QI Standard that received approval of more than 75 % (consensus criterion) of the consensus panel. RESULTS: Based on the agreed QI Standard, the QI development process starts with a criteria-based selection of "potential" QIs which - in case of adoption - are published in CPGs as "preliminary" QIs and can achieve the status "final" after successful testing. The QI Standard is composed of a total of 30 recommendations, which are allocated to six areas: A) preparatory work steps for the guideline-based recommendation of QIs, B) QI development group and cooperation with the CPG group, C) development of potential QIs, D) critical appraisal of potential QIs, E) formal adoption and publication as well as F) piloting/testing of preliminary QIs and conversion into final QIs. DISCUSSION: Before the QI Standard can be recommended for implementation in future CPGs, it should have been successfully tested in selected German CPG projects. In addition to methodological requirements for the QI development, it must be ensured that guideline groups have adequate resources for the implementation of the QI Standard. CONCLUSION: By using the QI Standard, scientifically sound and healthcare-relevant QIs can be expected.

The German Multicentre Study on Multiple Chemical Sensitivity (MCS).

In this multicentre study on multiple chemical sensitivity (MCS) 291 consecutive environmental medicine (EM) outpatients were examined in several environmental medicine outpatient centres/units throughout Germany in 2000/2003. Of the EM outpatients, 89 were male (30.6%) and 202 were female (69.4%), aged 22-80 (mean 48 years, S.D.=12 years). The sample was representative for university-based environmental outpatient departments and represented a cross-sectional study design with an integrated clinical-based case-control comparison (MCS vs. non-MCS). Three classifications of MCS were used: self-reported MCS (sMCS), clinically diagnosed MCS (cMCS), and formalised computer-assisted MCS with two variants (f1MCS, f2MCS). Data were collected by means of an environmental medicine questionnaire, psychosocial questionnaires, the German version of the Composite International Diagnostic Interview (CIDI), and a medical baseline documentation, as well as special examinations in partial projects on olfaction and genetic susceptibility markers. The hypothesis guided evaluation of the project showed that the patients' heterogenic health complaints did not indicate a characteristic set of symptoms for MCS. No systematic connection could be observed between complaints and the triggers implicated, nor was there any evidence for a genetic predisposition, or obvious disturbances of the olfactory system. The standardised psychiatric diagnostics applying CIDI demonstrated that the EM patients in general and the subgroup with MCS in particular suffered more often from mental disorders compared to an age and gender matched sample of the general population and that in most patients these disorders commenced many years before environment-related health complaints. Our results do not support the assumption of a toxicogenic-somatic basis of the MCS phenomenon. In contrast, numerous indicators for the relevance of behavioural accentuations, psychic alterations or psychosomatic impairments were found in the group of EM-outpatients with subjective "environmental illness".