Peter F. Matthiessen

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

BackgroundIt 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.MethodsThe 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.ResultsA checklist is presented, in which the evaluation criteria concerning external validity and model validity are systemised and transformed into a questionnaire format.ConclusionThe 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.

Engagement of patients in religious and spiritual practices: Confirmatory results with the SpREUK-P 1.1 questionnaire as a tool of quality of life research

BackgroundQuality of life is a multidimensional construct composed of functional, physical, emotional, social and spiritual well-being. In order to examine how patients with severe diseases view the impact of spirituality and religiosity on their health and how they cope with illness, we have developed the SpREUK questionnaire. We deliberately avoided the intermingling of attitudes, convictions and practices, and thus addressed the distinct forms and frequencies of spiritual/religious practices in an additional manual, the SpREUK-P questionnaire.MethodsThe SpREUK-P was designed to differentiate spiritual, religious, existentialistic and philosophical practices. It was tested in a sample of 354 German subjects (71% women; 49.0 ± 12.5 years). Half of them were healthy controls, while among the patients cancer was diagnosed in 54%, multiple sclerosis in 22%, and other chronic diseases in 23%. Reliability and factor analysis of the inventory were performed according to the standard procedures.ResultsWe confirmed the structure and consistency of the previously described 18-item SpREUK-P manual and improved the quality of the current construct by adding several new items. The new 25-item SpREUK-P 1.1 (Cronbachs alpha = 0.8517) has the following scales: (1) conventional religious practice (CRP), (2) existentialistic practice (ExP), (3) unconventional spiritual practice (USP), (4) nature/environment-oriented practice (NoP), and (5) humanistic practice (HuP). Among the tested individuals, the highest engagement scores were found for HuP and NoP, while the lowest were found for the USP. Women had significantly higher scores for ExP than male patients. With respect to age, the engagement in CRP increases with increasing age, while the engagement in a HuP decreased. Individuals with a Christian orientation and with a religious and spiritual attitude had the highest engagement scores for CRP, while the engagement in an USP was high with respect to a spiritual attitude. Variance analyses confirmed that the SpR attitude and religious affiliation are the main relevant covariates for CRP and ExP, while for the USP the SpR attitude and the educational level are of significance, but not religious affiliation. Patients with multiple sclerosis overall had the lowest engagement scores for all five forms of SpR practice, while it is remarkable that cancer patients had lower scores for HuP and USP than healthy subjects.ConclusionThe current re-evaluation of the SpREUK-P questionnaire (Version 1.1) indicates that it is a reliable, valid measure of five distinct forms of spiritual, religious and philosophical practice that may be especially useful for assessing the role of spirituality and religiosity in health related research. An advantage of our instruments is the clear-cut differentiation between convictions and attitudes on the one hand, and the expression of these attitudes in a concrete engagement on the other hand.

Effectiveness, Safety and Cost-Effectiveness of Homeopathy in General Practice – Summarized Health Technology Assessment

Introduction: The Health Technology Assessment report on effectiveness, cost-effectiveness and appropriateness of homeopathy was compiled on behalf of the Swiss Federal Office for Public Health (BAG) within the framework of the ‘Program of Evaluation of Complementary Medicine (PEK)’. Materials and Methods: Databases accessible by Internet were systematically searched, complemented by manual search and contacts with experts, and evaluated according to internal and external validity criteria. Results: Many high-quality investigations of pre-clinical basic research proved homeopathic high-potencies inducing regulative and specific changes in cells or living organisms. 20 of 22 systematic reviews detected at least a trend in favor of homeopathy. In our estimation 5 studies yielded results indicating clear evidence for homeopathic therapy. The evaluation of 29 studies in the domain ‘Upper Respiratory Tract Infections/Allergic Reactions’ showed a positive overall result in favor of homeopathy. 6 out of 7 controlled studies were at least equivalent to conventional medical interventions. 8 out of 16 placebocontrolled studies were significant in favor of homeopathy. Swiss regulations grant a high degree of safety due to product and training requirements for homeopathic physicians. Applied properly, classical homeopathy has few side-effects and the use of high-potencies is free of toxic effects. A general health-economic statement about homeopathy cannot be made from the available data. Conclusion: Taking internal and external validity criteria into account, effectiveness of homeopathy can be supported by clinical evidence and professional and adequate application be regarded as safe. Reliable statements of cost-effectiveness are not available at the moment. External and model validity will have to be taken more strongly into consideration in future studies.

Use of complementary medicine in Switzerland

Within the framework of the Swiss governmental Program of Evaluation of Complementary Medicine (PEK) we assessed the prevalence, use, perceived effectiveness and appreciation of complementary medicine (CAM) in Switzerland, according to published surveys. Materials and Methods: Search was performed through electronic databases, by hand-searching and by contacting experts at universities, hospitals, health insurances, patient organizations and pharmaceutical companies. Results: Surveys were carried out among the general population (40%), physicians (20%), hospitalized patients (30%) and obstetric institutions (5%). The number of publications increased strongly between 1981 and 2004. The mean ± SD prevalence (use) of CAM is 49 ± 22% and varies depending on the survey’s topic and the population group interviewed. The acceptance, appreciation or demand for CAM among individuals specifically interviewed on CAM is 91 ± 6%. When asked about favored general improvements in healthcare, 6.5% of the individuals spontaneously mentioned CAM. CAM therapies are considered to be effective by the majority of CAM users and by about 40% of cancer patients using CAM. Approximately 50% of the population stated a preference for hospitals that also provide CAM. 85% of the population wishes the costs for CAM to be covered by the basic health insurance. Conclusion: Approximately half of the Swiss population has used CAM. CAM treatment is considered to be effective by the majority of CAM users. About 50% of the population would prefer hospitals that also provide CAM therapies and the majority of the population wishes the cost for CAM therapies to be covered by basic health insurance.

Adaptive Coping and Spirituality as a Resource in Cancer Patients

Aim: We intended to clarify which strategies to control their diseases were utilized by patients with chronic diseases and whether they are convinced that spirituality/religiosity (SpR) may offer some beneficial effects. Patients and Methods: We investigated elderly German insurants and outpatients with chronic diseases with the SpREUK and AKU questionnaires. Results: Patients with chronic diseases relied on adaptive coping styles which refer to both external help (Trust in Medical Help, Search for Alternative Help, Trust in God’s Help) and internal powers/ virtues (Conscious and Healthy Living, Perspectives and Positive Attitudes). Reappraisal (Illness as Chance) was strongly connected with Trust in God’s Help, which was of relevance particularly for female cancer patients. Compared to patients with other chronic diseases, cancer patients were significantly more in Search for Meaningful Support, had Trust in Higher Source and a Positive Interpretation of Disease. Women with breast cancer had significantly higher interest in Search for Meaningful Support and Positive Interpretation than patients with prostate cancer. The SpR attitudes and convictions were significantly influenced by gender, SpR self-categorization, and educational level. Conclusion: Particularly women with breast cancer refer to SpR issues and existential practices in order to better cope with their illness. In medical context, however, these needs are often neither recognized nor addressed.

Complementary Therapy Systems and Their Integrative Evaluation

Complementary and alternative medicine (CAM) is becoming an integral part of modern medicine. Complementary and alternative medicine therapy systems include natural medicinal products, nonpharmacological treatments, and counselling on health and lifestyle issues. Complementary and alternative medicine concepts are often elaborate, transcending biophysical models and employing the principles of salutogenesis. Evaluations of CAM therapy systems need to be integrative and cover the dimensions of: (1) therapeutic professionalism; (2) patient perspective and public demand; (3) conceptuality; (4) safety, effectiveness, and costs. Complex research strategies are required, which reverse the phases of conventional drug assessment. The predominant use of randomized trials would introduce structural bias and create an artificial picture. Important are evaluations of the whole system in real-world conditions, and surveys on component evaluations. Systemic CAM assessments should consist of a broad array of high-quality research methods: well-conducted randomized and nonrandomized studies, cohort studies, qualitative research, high-quality case reports and case series, studies on patient perspective, safety analyses, economic analyses, etc. Good clinical judgement, a core epistemic element of medicine based on nonstochastic principles, should also be integrated and could reflect routine patient care.

Homeopathy in Healthcare – Effectiveness, Appropriateness, Safety, Costs

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Eurythmy Therapy in clinical studies: a systematic literature review

.m p. o r H EA LT H C A RE C O ST / or C O ST O F IL LN ES S/

Pilotstudie zur Entwicklung eines Fragebogens zur Erfassung der spirituellen und religiösen Einstellung und des Umgangs mit Krankheit (SpREUK)

BackgroundWe aimed to overview the current literature on eurythmy therapy (EYT) which is an integral part of Anthroposophic Medicine. EYT can be described as a movement therapy in which speech movements are transposed into exercises which address the patients capability to soul expression and strengthen his salutogenetic resources.MethodsWe searched several databases such as Cochrane, EMBASE, NCCAM, NLM, DIMDI, CAMbase, and Medline for case-control studies, cohort studies and randomised controlled trials on the treatment effects of EYT in a clinical setting. In a second search we included journal databases from Karger, Kluwer, Springer, Thieme, and Merkurstab archive.ResultsWe found 8 citations which met the inclusion criterion: 4 publications referring to a prospective cohort study without control group (the AMOS study), and 4 articles referring to 2 explorative pre-post studies without control group, 1 prospective, non-randomized comparative study, and 1 descriptive study with a control group. The methodological quality of studies ranged in from poor to good, and in sample size from 5 to 898 patients. In most studies, EYT was used as an add-on, not as a mono-therapy. The studies described positive treatment effects with clinically relevant effect sizes in most cases.ConclusionIndications, study designs and the usage of additional treatments within the identified studies were quite heterogeneous. Despite of this, EYT can be regarded as a potentially relevant add-on in a therapeutic concept, although its specific relevance remains to be clarified. Well performed controlled studies on this unique treatment are highly recommended.

Effects of rhythmic embrocation therapy with solum oil in chronic pain patients: a prospective observational study.

Pilot Study for the Development of a Questionnaire for the Measuring of the Patientsʼ Attitude towards Spirituality and Religiosity and Their Disease Coping (SpREUK) Objective: Life-threatening diseases are the standard situations which confront patients with spirituality and religiosity. Although both are wellknown factors in disease coping, their measurability and operationability remains a basic problem due to the variety of different meanings and interpretations of these terms. In this paper we describe the development of a questionnaire for the measuring of the patientsʼ attitudes towards spirituality and religiosity and their disease coping (SpREUK). Material and Methods: For a first evaluation, 129 patients with a mean age of 54 years (SD 14.3) completed the questionnaire. 67% of them were women. 76% had a Christian denomination, 19% no denomination, and only 4% reported other religious traditions. 45% of the patients suffered from cancer, 18% from multiple sclerosis, 22% from other chronic diseases, and 15% from acute diseases. The questionnaire comprises 29 five-stage likert-scaled items. Apart from a descriptive analysis of the single items, reliability (Cronbachʼs alpha) and validity analysis (factor analysis) of the questionnaire was performed. Results: Factor analysis resulted in four dimensions: (1) ʼSearch for meaningful supportʼ, (2) ʼGuidance, control and message of diseaseʼ, (A) ʼSupport in relations with the external through spirituality/religiosityʼ, and (B) ʼStabilization of the inner condition through spirituality/religiosityʼ. The reliability of the four scales of the SpREUK questionnaire is high: Cronbach’s alpha 0.82, 0.62, 0.89, resp. 0.74. Women had significantly higher SpREUK scores for scales 1 and 2 than male patients. Non-denominational patients had significantly lower scores in all four scales than those with a Christian denomination. The scores did not correlate with disease or duration of disease; however, there might be a positive correlation between age and the score of scale 2. Discussion: The impact of spirituality and religiosity on the course of disease, coping skills, and health-related quality of life is broadly discussed not only in complementary medicine. With the SpREUK questionnaire we present a reliable and valid instrument to measure the patientsʼ search for meaningful support through spirituality/religiosity in terms of disease coping and health restoration. Further evaluation of this instrument is planned with a focus on hospitals which are affiliated with a specific denomination, as a reasonable extension of quality management and concept development.