Nurse-led immunotreatment DEcision Coaching In people with Multiple Sclerosis (DECIMS) - Feasibility testing, pilot randomised controlled trial and mixed methods process evaluation.

BACKGROUND: Treatment decision-making is complex for people with multiple sclerosis. Profound information on available options is virtually not possible in regular neurologist encounters. The "nurse decision coach model" was developed to redistribute health professionals' tasks in supporting immunotreatment decision-making following the principles of informed shared decision-making. OBJECTIVES: To test the feasibility of a decision coaching programme and recruitment strategies to inform the main trial. DESIGN: Feasibility testing and parallel pilot randomised controlled trial, accompanied by a mixed methods process evaluation. SETTING: Two German multiple sclerosis university centres. PARTICIPANTS PILOT TRIAL: People with suspected or relapsing-remitting multiple sclerosis facing immunotreatment decisions on first line drugs were recruited. Randomisation to the intervention (n = 38) or control group (n = 35) was performed on a daily basis. Quantitative and qualitative process data were collected from people with multiple sclerosis, nurses and physicians. METHODS: We report on the development and piloting of the decision coaching programme. It comprises a training course for multiple sclerosis nurses and the coaching intervention. The intervention consists of up to three structured nurse-led decision coaching sessions, access to an evidence-based online information platform (DECIMS-Wiki) and a final physician consultation. After feasibility testing, a pilot randomised controlled trial was performed. People with multiple sclerosis were randomised to the intervention or control group. The latter had also access to the DECIMS-Wiki, but received otherwise care as usual. Nurses were not blinded to group assignment, while people with multiple sclerosis and physicians were. The primary outcome was 'informed choice' after six months including the sub-dimensions' risk knowledge (after 14 days), attitude concerning immunotreatment (after physician consultation), and treatment uptake (after six months). Quantitative process evaluation data were collected via questionnaires. Qualitative interviews were performed with all nurses and a convenience sample of nine people with multiple sclerosis. RESULTS: 116 people with multiple sclerosis fulfilled the inclusion criteria and 73 (63%) were included. Groups were comparable at baseline. Data of 51 people with multiple sclerosis (70%) were available for the primary endpoint. In the intervention group 15 of 31 (48%) people with multiple sclerosis achieved an informed choice after six months and 6 of 20 (30%) in the control group. Process evaluation data illustrated a positive response towards the coaching programme as well as good acceptance. CONCLUSIONS: The pilot-phase showed promising results concerning acceptability and feasibility of the intervention, which was well perceived by people with multiple sclerosis, most nurses and physicians. Delegating parts of the immunotreatment decision-making process to trained nurses has the potential to increase informed choice and participation as well as effectiveness of patient-physician consultations.

[Effect of Evidence-Based Risk Information on "Informed Choice" in Colorectal Cancer Screening: Randomised Controlled Trial]. / Effekt einer evidenzbasierten Verbraucherinformation zur Entscheidungsfindung beim kolorektalen Screening.

Evidence-based information is a prerequisite for informed choice. We compared the effect of evidence-based information on colorectal cancer screening with standard information in a randomised controlled trial. The primary endpoint was informed choice. We randomised 1,577 people insured by a large German statutory health insurance scheme, the Gmünder Ersatzkasse (GEK). The evidence-based information significantly increased informed choices: 44.0% vs. 12.8%; (difference 31.2%, 99% CI 25.7-36.7%; P<0.001).

Evidence base in guideline generation in diabetes.

During recent years much emphasis has been on the validity, reliability, reproducibility, clinical applicability, clarity, multidisciplinary process, scheduled review and documentation of clinical practice guidelines (CPGs). Still, CPGs show substantial variance in methodological quality. The present paper mainly focuses on two aspects that are particularly critical and contemporary from the perspective of evidence-based medicine: patient centredness and shared decision making, and conflict of interest. Sophisticated patient and consumer involvement at all stages of CPG development could be judged as being the gold standard. However, co-opting patients or consumer representatives and using other techniques of active patient involvement does not replace individual patient preferences in clinical decision-making processes. Current CPGs do not meet patient needs, since they do not provide concise, easy-to-read summaries of the benefits and risks of medicines together with more comprehensive scientific data as a prerequisite for informed or shared decision making. The vast majority of CPG panels have a financial conflict of interest (COI) and under-reporting is common. Not all organisations producing CPGs have set up COI policies, and existing policies vary widely. To solve the problem, CPG experts have recommended that methodologists without any important COI should lead the development process and have primary responsibility. There is a lot of room for other improvements through network transnational activities in the field of CPG development. Waste of time and resources should be avoided through sharing published and unpublished data identified, appraised and extracted for guideline development. The EASD could provide such a clearing house.

From authority recommendations to fact-sheets--a future for guidelines.

ADA/EASD recommendations and diabetes expert consensus statements are not evidence-based. Reform of guideline development is urgently needed. Overriding governance and composition of the guideline committee is a key problem. Methodologists without important conflicts of interest should lead the development process and have primary responsibility. The rating of the quality of evidence should be separated from making the recommendations, transparency has to be increased and conflicts of interest must be tackled. Patient needs are not yet met in guidelines. Patients increasingly demand concise, easy-to-read summaries of the benefits and risks of medicines together with more comprehensive scientific data. However, patient participation in individual decision making is not considered in guidelines. Guidelines do not provide the information necessary for informed or shared decision making. Study fact-sheets and drug facts boxes should be included in practice guidelines. It is timely to consider patient needs from the outset of the development of future guidelines.

[Validity of clinical trials: are there differences between conventional and complementary alternative medicine?]. / Studienvalidität: Gibt es Unterschiede zwischen Schul- und Komplementärmedizin?

So far there has been no consensus on the criteria which confirm the validity of scientific contributions in conventional medicine (CM) and complementary/ alternative medicine (CAM). An interdisciplinary group of experts from various disciplines within each of the areas of medicine held six well-documented sessions in an effort to reach a consensus. The group agreed that the methods to confirm the validity of clinical trials are identical in CM and CAM. There are differences in research strategies and there may also be differences in interpreting the results, depending on the concept of medicine.

Suspected multiple sclerosis - what to do? Evaluation of a patient information leaflet.

BACKGROUND: Parallel to the establishment of early treatments in multiple sclerosis (MS), new diagnostic criteria have made an earlier diagnosis possible. While there is ongoing discussion about possible benign courses and only partial effective treatments, there have been no attempts today to facilitate shared decision making on diagnostic testing between patients with suspected MS and their physicians. OBJECTIVE: This study describes the development and validation process of a leaflet to be presented to people with suspected MS to engage them in a diagnostic decision-making process. METHODS: After a qualitative study showing acceptability among five patients, the leaflet was presented to a retrospective cohort (n = 87 of which 70 replied)) of patients being diagnosed within the last 2 years as well to a prospective cohort of n = 51 patients with symptoms suggestive of MS. RESULTS: Approximately 70% of patients in the prospective as well as in the retrospective cohort wanted to be informed about a possible MS before testing, whereas 10% did not. The leaflet did not seem to elicit anxieties. The attitude to undergo diagnostic testing was not influenced by the leaflet, which can be explained by the nonexperimental design of the study. CONCLUSION: Taken together, our findings demonstrate that early information about possible MS is warranted by patients and does not show negative side effects. Further studies on evidence-based patient information in early MS seem necessary.

[Evidence-based patient information: the example of immunotherapy for patients with multiple sclerosis]. / Evidenzbasierte Patienteninformation--dargestellt am Beispiel der Immuntherapie bei Patienten mit Multipler Sklerose.

The article elucidates consideration of scientific criteria for the development and design of evidence-based patient information (EBPI). Immunotherapy of multiple sclerosis serves as an example. Since in EBPI lack of evidence or ambiguities in available evidence are explicitly communicated, processing of EBPI does not necessarily lead to certainty about benefit and harms of medical interventions. However, only if the information is comprehensive in this respect can the EBPI be regarded as a robust basis for an informed choice. EBPI requires substantial developmental efforts. Regarding the growing number of medical interventions and the half-life of information, the question of responsibility for provision of EBPI is crucial. A vision is drafted in which EBPI is driven by demand of the patients and the public and is provided according to a costs-by-cause principle by those who distribute usual information hitherto. Trained patient advocates can appraise quality of information by use of instruments that consider criteria of EBPI. Critical health literacy should evolve early in school and can later on enhance usefulness of EBPI for people concerned with health issues.

Patient education program to enhance decision autonomy in multiple sclerosis relapse management: a randomized-controlled trial.

BACKGROUND: Contrary to strong recommendations for high-dose intravenous corticosteroid treatment for relapses in multiple sclerosis (MS), uncertainty remains about most aspects of relapse management. Oral corticosteroids administered by physicians or patients themselves or no corticosteroids also appear justifiable. OBJECTIVE: To evaluate an education program that aims to involve patients with MS in decisions on relapse management. METHODS: In three German MS centers, 150 patients with relapsing MS were randomly assigned to a single, 4-h group session or a standard information leaflet. The primary outcome measure was the proportion of relapses with oral or no corticosteroid therapy as an indicator of patient autonomy in treatment decision making. Other outcomes included perceived decision autonomy, quality of life, and disability status. RESULTS: In the intervention group (IG), 108/139 (78%) relapses were treated with oral or no corticosteroids compared with 101/179 (56%) in the control group; P < 0.0001. Patients' perceived autonomy of treatment decision making was significantly higher in the IG; P < 0.0001. Quality of life, disability status, and adverse events of corticosteroid therapies were comparable. CONCLUSION: The patient education program led to more autonomous decision making in patients with relapsing MS. Relevant changes in relapse management were observed.

Informed shared decision making about immunotherapy for patients with multiple sclerosis (ISDIMS): a randomized controlled trial.

BACKGROUND AND PURPOSE: To evaluate the effects of an evidence-based patient decision aid (DA) on multiple sclerosis (MS) immunotherapy. METHODS: Two hundred and ninety-seven MS patients who were considering or reconsidering immunotherapy participated in a randomized community-based controlled trial in Germany. An intervention group (IG) received the DA and a control group (CG) received standard information. Primary outcome measure was the match between the patient's preferred and actual roles during consultation with the physician. Secondary end-point was treatment choice. The course of the decision-making process and patients; evaluation of the decision were also evaluated. Data were collected at baseline, after receiving the information, after consultation with the physician and 6 months after baseline. RESULTS: The percentage of preference matches did not differ between groups (IG 49%, CG 51%, P = 0.71). There were no differences in immunotherapy choices between groups. IG patients temporarily became more critical of immunotherapy and rated the information as significantly more helpful. CONCLUSIONS: Although the intervention led to intensified processing of the information it affected neither the roles adopted in physician-patient encounters nor the immunotherapy choices made. Providing patients with balanced information may not be sufficient to alter the decision-making process.

Meta-analysis does not allow appraisal of complex interventions in diabetes and hypertension self-management: a methodological review.

Common methodologies used in systematic reviews do not allow adequate appraisal of complex interventions. The aim of the present study was to describe and critically appraise current methods of systematic reviews on complex interventions, using diabetes and hypertension patient education as examples. PubMed, the Cumulative Index to Nursing and Allied Health (CINAHL), the Cochrane Library and Health Technology Assessment databases were searched. Systematic reviews focusing on diabetes or hypertension patient education were included. Authors were contacted. Two investigators independently evaluated the reviews. The available evidence of three patient education programmes of diabetes and hypertension self-management implemented in Germany was used as a reference. We included 14 reviews; 12 reviews mentioned that the included education programmes were multidimensional. Reviews on comparable topics identified different publications of the same programme. Identical programmes were classified differently within and between reviews. Education programmes were dissected to analyse effects of single components. Different components of identical programmes were used. Interdependencies between components were not explored. Six reviews performed meta-analysis across programmes with heterogeneous educational or organisational approaches. The complexity of efficacy measures was disregarded: e.g. HbA(1c) was used as an isolated outcome variable without considering treatment goals, effects on hypoglycaemia, body weight or quality of life. Our results indicate that methods of current systematic reviews are not fully equipped to appraise patient education and self-management programmes. Since these are complex and heterogeneous interventions, consideration of aggregated evidence is necessary.