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.

Patient education programmes and decision aids - evaluation of complex interventions

Patients have the right to make informed decisions on treatmentgoals and treatment regimens and also to be provided with reliableinformation necessary for decision-making. Evidence-based medicineexplicitly integrates patients” values and preferences in treatmentdecisions. Both are regarded as crucial to increase both thepatients” quality of care and independence. Education programmesor patient decision aids are complex interventions, typically comprisingseparate components acting interdependently (e.g. content,structure, and media of an education programme). They are heterogeneousin their goals, methods and target populations. Developmentand evaluation of complex interventions are sophisticatedprocesses requiring both qualitative and quantitative methods. In aprevious review we showed that common methodologies used insystematic reviews do not allow adequate appraisal of complex interventions.Patient education programmes were used as an example.The present review outlines present developments in patienteducation and shared decision making in diabetes care. It also comprisesan update of the previous review. Methodological challengesof the development and evaluation of complex interventions are discussed.Methods of current systematic reviews do still not meet thechallenges to appraise patient education and self-management programmes.Since these are complex and heterogeneous interventions,consideration of aggregated evidence is necessary. Informationnecessary for the evaluation of such programmes is difficult orimpossible to identify. In conclusion we propose to establish a scientificnetwork and database, which supports scientific exchange andsystematic tagging of self-management programmes, patient educationprogrammes and patient decision aids(AU)

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.

Evidence-based medicine for diabetes educators: a pilot study.

AIMS: Health-care professionals are increasingly asked to communicate research results to patients and consumers. Diabetes educators play a decisive role in the information process of patients with diabetes. Evidence-based medicine (EBM) is not a regular part of their training in Germany. We performed a pilot study to test whether the inclusion of a short EBM module into the standard graduate programme is feasible and leads to a meaningful increase in knowledge and skills. METHODS: The study group consisted of 121 diabetes educator trainees. The EBM modules were delivered in 1- to 3-day courses. Increase in knowledge and skills were assessed using a questionnaire covering three main elements: (i) general aspects of an intervention study, (ii) effect size calculation, (iii) general aspects of evidence-based patient information and communicating numbers as patient orientated statements. Two researchers independently rated the assessment sheets. RESULTS: The majority of participants rated the course as important and useful but too short. Knowledge and skills in EBM increased after the course by 2 points out of 13.5 (mean score before course 5 +/- 2 vs. 7 +/- 2; P < 0.001). Inter-rater reliability analysis using Cohen's Kappa coefficients demonstrated substantial to almost perfect agreement for 10 of the 13 items. CONCLUSIONS: Our pilot study demonstrates that EBM education for diabetes educator trainees is feasible. However, the increase in knowledge and skills appears not to be clinically relevant. Short EBM courses are unlikely to yield important effects. More intensified course formats are necessary to meet the needs of diabetes educators.

Informed shared decision making in multiple sclerosis--inevitable or impossible?

Patients and health authorities increasingly claim active roles in health care decision making processes. As immune therapies in MS are partially effective MS is a prototypic condition for a shared decision making process. The treatment of acute relapses and the initiation, change or withdrawal of so called disease-modifying treatments are key decisions in MS management. We developed two decision aids following the phased approach of the framework of increasing evidence for complex interventions for these key decisions. In prestudies we found that 80% of MS patients demand autonomous roles in treatment decisions which contrasts with a poor knowledge of risks. On the other hand MS patients are not disturbed by evidence-based, balanced complex information. MS patients do understand this kind of information and are able to transfer new abilities to other situations. Currently we study the effects of a 4-hour education programme on relapse management versus an information leaflet in controls in 150 MS patients. In a second trial with n=298 MS patients we study the effects of an evidence-based patient information on immunotherapy on decisional role preference and performance in the patient physician encounter. Results in early 2007 will show to which extent patient education with a focus on evidence-based patient information influences participation in the decision making process.

Searching for diabetes decision aids and related background information.

AIMS: Patient decision aids (DAs) are interventions designed to help patients making informed decisions. DAs are complex interventions comprising a number of active components each essential to the proper functioning of the aid. Critical appraisal of DAs therefore requires access to information describing the incremental assessment of each stage in their development, including information about the theoretical funding, development processes, efficacy trials and long-term implementation. We explored the feasibility of identifying such information with conventional database search strategies. Our study was conducted only in the field of diabetes care. METHODS: The 'Inventory of Existing Patient Decision Aids', medline (PubMed) and the World Wide Web were used to identify DAs relevant for diabetes care. For tracking information concerning each developmental stage, the reference lists of the DAs, home pages of the authors, medline, embase, PsycINFO, cinahl, and the Cochrane database were searched systematically. RESULTS: A total of 13 DAs relevant for diabetes care were identified. The search for publications concerning their development yielded more than 3000 results, only 10 of which referred to at least one of the 13 DAs. No additional background information was found on the home pages of the authors. CONCLUSIONS: Conventional database search strategies do not allow the extraction of information about the stages in development of a DA. To facilitate critical appraisal of DAs, we propose the creation of an electronic database which provides information about available DAs, together with the relevant background literature, or to incorporate such a system into existing databases.

Understanding of diabetes prevention studies: questionnaire survey of professionals in diabetes care.

AIMS/HYPOTHESIS: Diabetes prevention studies have reported reductions of diabetes risk by up to 60%. Since the underlying metabolic changes are small, the clinical significance of this effect may be overestimated. The present survey explores the extent to which different formats of presenting study results may influence diabetes healthcare professionals' perceptions of the importance of intervention effects on diabetes risk. SUBJECTS, MATERIALS AND METHODS: Participants of three European diabetes conferences (160 nurse educators, 112 physicians, 27 other professionals) were presented with a questionnaire that included nine items, in which results from three diabetes prevention studies were presented in different ways. RESULTS: Participation rate was 96%. Effects were interpreted as important or very important by 92% (255/276) when results were presented as proportions of subjects with diabetes (14% intervention group, 29% control group), by 87% (248/285) when results were communicated as a risk reduction of 57%, by 39% (110/284) when the corresponding fasting plasma glucose values were presented (mean difference 0.3 mmol/l), and by 18% (52/283) when glycosylated haemoglobin values were used (6.0 vs 6.1%). Corresponding results of the three diabetes prevention studies were rated as being of identical importance by only 23, 13 and 16% of participants, respectively. CONCLUSIONS AND INTERPRETATION: Healthcare professionals rate the benefit of preventive interventions substantially higher when changes in diabetes risk are communicated rather than related glycaemic parameters. Transformation of continuous metabolic data into diagnostic categories may impair understanding of study effects.

Glycaemic control and severe hypoglycaemia following training in flexible, intensive insulin therapy to enable dietary freedom in people with type 1 diabetes: a prospective implementation study.

AIMS/HYPOTHESIS: The aim of this study was to evaluate the implementation of a course teaching flexible, intensive insulin therapy on glycaemic control and severe hypoglycaemia in routine care. METHODS: This is a continuous quality-assurance project involving hospital diabetes centres. Every third year each centre re-examines 50 consecutive patients (evaluation sample) 1 year after participation in the course. Ninety-six diabetes centres in Germany participated and 9,583 patients with type 1 diabetes (190 evaluation samples) were re-examined between 1992 and 2004. The intervention was a 5-day inpatient course for groups of up to ten patients with a fixed curriculum of education and training for dietary flexibility and insulin adjustment. The main outcome measures were HbA1c and severe hypoglycaemia. RESULTS: Mean baseline HbA1c was 8.1%, and had decreased to 7.3% at follow-up; incidence of severe hypoglycaemia was 0.37 events per patient per year prior to intervention and 0.14 after intervention. In mixed-effects models adjusted for effects of centres, age and diabetes duration, the mean difference was -0.7% (95% CI -0.9 to -0.6%, p<0.0001) for HbA1c and -0.21 events per patient per year (95% CI -0.32 to -0.11, p=0.0001) for severe hypoglycaemia, with similar results for evaluation samples, with a maximum of 10% of patients lost to follow-up. Before intervention, the incidence of severe hypoglycaemia was three-fold higher in the lowest quartile than in the highest quartile of HbA1c, whereas the risk was comparable across the range of HbA1c values after intervention. CONCLUSIONS/INTERPRETATION: Implemented as part of a continuous quality-assurance programme the self-management programme is effective and safe in routine care. Improvement of glycaemic control can be achieved without increasing the risk of severe hypoglycaemia.

Validation of a quality of life questionnaire measuring the subjective fear of falling in nursing home residents.

A quality of life scale was developed to measure the subjective fear of falling in nursing home residents. We assessed the dimensions fear of falling, daily living and social life within a randomized controlled trial of hip protector use. The Nottingham Health Profile (NHP) was used for validation. Statistical analysis covered factor analysis, internal consistency of subscales, construct and discriminant validity. Factor analysis revealed three reliable components (Cronbach's Alpha): fear of falling (0.92), social restriction due to limited mobility (0.74) and restriction by clothes due to the hip protector (0.72). The subscales fear of falling and social restriction were significantly intercorrelated with all subscales of the NHP. The new tool is a reliable and valid measure of fear of falling in nursing home residents. However, generalizability and applicability are limited by the small proportion of subjects able to complete the tests.

Steroid treatment for relapses in multiple sclerosis - the evidence urges shared decision-making.

OBJECTIVES: Therapy of acute relapses in multiple sclerosis with corticosteroids (CC) remains uncertain with respect to route, dosage and effectiveness. This makes the treatment of relapses a clinical field where 'shared decision-making (SDM)' could be of advantage for the patients. A prerequisite for SDM is the provision of evidence-based information for the patients. The British General Medical Council (GMC) has published ethical guidelines on seeking patients' consent for medical interventions, formulating topics of information patients need in order to make an informed treatment decision. METHODS: Medical databases were searched for evidence on the treatment of acute relapses with CC. RESULTS: The available evidence on relapse treatment is ambiguous and weak. It does not provide enough evidence to sufficiently inform patients following the topics formulated by the GMC. CONCLUSION: Good evidence is lacking, supporting the concept of SDM in the therapy of relapses.

[Graduated compression stockings in surgery -- optional or obligatory?]. / Thromboseprophylaxestrümpfe in der Chirurgie-optional oder obligat?

BACKGROUND: Graduated compression stockings (GCS) can effectively reduce postoperative deep vein thrombosis (DVT) and their use is recommended by expert committees. However, it appears that GCS are not frequently used. The objectives of this study are to evaluate the customary use of GCS in surgical settings in the City of Hamburg, Germany, and to present evidence on the effectiveness of GCS. METHODS: A questionnaire on the use of thromboprophylaxis was sent to 48 surgeons in Hamburg. In addition, a comprehensive search for randomized-controlled trials, reviews, and meta-analyses indexed in MEDLINE (1984-06/2002) and the Cochrane Library (Issue 2, 2002) was conducted to show the effectiveness of GCS compared to nontreatment, other antithrombotic methods, or combined treatment. RESULTS: Of 48 surgeons 39 responded. Seven surgeons dismissed the use of GCS for thromboprophylaxis, 3 used GCS alone, 25 GCS in combination with heparin, and 4 used GCS only for patients at high risk. The review of the literature revealed the effectiveness of GCS in general and for abdominal surgical patients. Enhanced benefit is suggested when combining GCS with another intervention such as low-dose unfractionated heparin. Single application of GCS in orthopedic surgical or neurosurgical patients using venography showed no effect when compared to combined treatment of GCS and low molecular weight heparin. Trials with patients undergoing gynecological and urological surgeries are rare. There is a lack of trials investigating health-related quality of life and costs associated with the use of GCS. Complications are poorly reported. A determination as to the appropriate length of stockings is presently not possible. CONCLUSIONS: GCS should be integral part of DVT prophylaxis in surgical departments. Their ineffectiveness is likely in some surgical populations.