Sascha Köpke

Decisional role preferences, risk knowledge and information interests in patients with multiple sclerosis

Objective: Shared decision making is increasingly recognized as the ideal model of patient-physician communication especially in chronic diseases with partially effective treatments as multiple sclerosis (MS). To evaluate prerequisite factors for this kind of decision making we studied patients’ decisional role preferences in medical decision making, knowledge on risks, information interests and the relations between these factors in MS. Methods: After conducting focus groups to generate hypotheses, 219 randomly selected patients from the MS Outpatient Clinic register (n=1374) of the University Hospital Hamburg received mailed questionnaires on their knowledge of risks in MS, their perception of their own level of knowledge, information interests and role preferences. Results: Most patients (79%) indicated that they preferred an active role in treatment decisions giving the shared decision and the informed choice model the highest priority. MS risk knowledge was low but questionnaire results depended on disease course, disease duration and ongoing immune therapy. Measured knowledge as well as perceived knowledge was only weakly correlated with preferences of active roles. Major information interests were related to symptom alleviation, diagnostic procedures and prognosis. Conclusion: Patients with MS claimed autonomous roles in their health care decisions. The weak correlation between knowledge and preferences for active roles implicates that other factors largely influence role preferences.

Reporting standards for studies of diagnostic test accuracy in dementia: The STARDdem Initiative

Objective: To provide guidance on standards for reporting studies of diagnostic test accuracy for dementia disorders. Methods: An international consensus process on reporting standards in dementia and cognitive impairment (STARDdem) was established, focusing on studies presenting data from which sensitivity and specificity were reported or could be derived. A working group led the initiative through 4 rounds of consensus work, using a modified Delphi process and culminating in a face-to-face consensus meeting in October 2012. The aim of this process was to agree on how best to supplement the generic standards of the STARD statement to enhance their utility and encourage their use in dementia research. Results: More than 200 comments were received during the wider consultation rounds. The areas at most risk of inadequate reporting were identified and a set of dementia-specific recommendations to supplement the STARD guidance were developed, including better reporting of patient selection, the reference standard used, avoidance of circularity, and reporting of test-retest reliability. Conclusion: STARDdem is an implementation of the STARD statement in which the original checklist is elaborated and supplemented with guidance pertinent to studies of cognitive disorders. Its adoption is expected to increase transparency, enable more effective evaluation of diagnostic tests in Alzheimer disease and dementia, contribute to greater adherence to methodologic standards, and advance the development of Alzheimer biomarkers.

Proposed criteria for reporting the development and evaluation of complex interventions in healthcare (CReDECI): guideline development

Methods of research on complex interventions have received increasing awareness in nursing and health care science. The British Medical Research Councils (MRC) framework on the development and evaluation of complex interventions has been widely applied. It does, however, not specifically support authors to comprehensively and transparently report their complex study to ensure interpretation of study results and replicability of the intervention. So far, no reporting criteria for the development and evaluation of complex interventions have been published. Based on the updated MRC framework and corresponding methodological literature, a set of criteria on the reporting and evaluation of complex interventions has been developed and reviewed by experts in the field. As a result, a criteria list comprising 16 items has been created covering the first three stages of the MRC framework: (1) development; (2) feasibility and piloting; and (3) introduction of the intervention and evaluation. The list provides a minimum standard of criteria necessary to ensure high quality reporting of studies on the development and evaluation of complex interventions. In a final step, the reporting criteria on complex interventions have to pass a formal consensus process according to the methods recommended by the EQUATOR network.

Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare: revised guideline (CReDECI 2)

BackgroundMany healthcare interventions are of complex nature, consisting of several interacting components. Complex interventions are often described inadequately. A reporting guideline for complex interventions was published in 2012 (Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare, CReDECI) and was recently checked for its practicability. The reporting guideline was developed following the recommendations of the EQUATOR network but excluding a formal consensus process. Therefore, a consensus process was initiated, to revise the reporting guideline.MethodsWe used a three-phase consensus process consisting of (1) a web-based feedback survey on the published reporting guideline, (2) a face-to-face consensus conference, and (3) a final online review and feedback round to create the revised CReDECI. The consensus process was organized and conducted via the REFLECTION network.ResultsA total of 45 attendees from 16 European countries took part in the face-to-face consensus conference. The revised reporting guideline (CReDECI 2) comprises 13 items on three stages: development, feasibility and piloting, and evaluation of a complex intervention. Each item is illustrated by an explanation and an example. In contrast with most of the available reporting guidelines, CReDECI 2 does not focus on a specific study design, to reflect the use of different qualitative and quantitative designs and methods in the development and evaluation of complex interventions.ConclusionsCReDECI 2 is a formally consented reporting guideline aiming to improve the reporting quality of the development and evaluation stages of complex interventions in healthcare. Since the guideline does not focus on a specific study design, design-specific reporting guidelines may additionally be used.

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.

The Tinetti test: Babylon in geriatric assessment.

SummaryThe Tinetti test has been recommended and widely used in the elderly to assess mobility, balance and gait, and predict falls. Different versions can be found. A systematic literature search identified 37 publications on the Tinetti test and falls. Wide variations were found concerning name of the instrument, test items, scoring, and cut-off values. This heterogeneity interferes with evaluations of the test’s validity, reliability and generalisability. Researcher and clinicians should be aware of this fact, when dealing with the Tinetti test.ZusammenfassungDer Tinetti-Test ist ein empfohlenes und weit verbreitetes Instrument zum Assessment von Mobilität, Balance und Gang sowie zur Sturzvorhersage. Verschiedene Versionen des Instruments liegen vor. Eine systematische Literatursuche identifizierte 37 Publikationen zum Tinetti-Test im Zusammenhang mit Stürzen. Große Variationen fanden sich in Bezug auf Name des Instruments, Items, Scoring und Schwellenwert. Diese Heterogenität erschwert die Evaluation von Validität, Reliabilität und Generalisierbarkeit des Instruments. Wissenschaftler und Kliniker, die dieses Instrument einsetzen, sollten sich dieser Problematik bewusst sein.

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.

Risk perception in natalizumab-treated multiple sclerosis patients and their neurologists

Background: Natalizumab is associated with the potentially life-threatening side-effect progressive multifocal leukoencephalopathy (PML). Little is known about patients’ and physicians’ risk estimates and attitudes towards natalizumab treatment. Methods: Consecutive natalizumab-treated patients (n = 69) and neurologists (n = 66) in two centres and cooperating private practices received an evidence-based three-page information leaflet about natalizumab-associated PML and an evaluation sheet. Results: After reading the information, patients were significantly more likely than physicians to intend continuation of natalizumab treatment and willing to accept higher risks of PML: 49% of physicians would stop treatment at a PML risk of 2 : 10,000 or lower, while only 17% of patients would do so (p < 0.001). This difference could not be explained by risk calculation abilities or lack of understanding. Both groups overestimated natalizumab treatment effects. Conclusion: Patients had a significantly worse perception of multiple sclerosis as a malignant disease. We conclude that patients were willing to accept a higher risk of PML than neurologists. Coherent with their perception of risks and benefits, patients were also more willing to continue treatment. Open information about treatment-related risks is appreciated and might support shared decision making.

Attitudes of Dutch, German and Swiss nursing staff towards physical restraint use in nursing home residents, a cross-sectional study

OBJECTIVE To investigate the attitudes of nursing staff towards restraint measures and restraint use in nursing home residents, and to investigate if these attitudes are influenced by country of residence and individual characteristics of nursing staff. METHODS A questionnaire on attitudes regarding restraints (subscales: reasons, consequences, and appropriateness of restraint use) and opinions regarding the restrictiveness of restraint measures and discomfort in using them was distributed to a convenience sample of nursing staff in The Netherlands (n=166), Germany (n=258), and Switzerland (n=184). RESULTS In general, nursing staff held rather neutral opinions regarding the use of physical restraints, but assessed the use of restraints as an appropriate measure in their clinical practice. Gender and age were not related to attitudes of nursing staff, but we did find some differences in attitudes between nursing staff from the different countries. Dutch nursing staff were most positive regarding the reasons of restraint use (p<0.01), but were less positive than German and Swiss nursing staff regarding the appropriateness of restraint use (p<0.01). Swiss nursing staff were less positive than German nursing staff regarding the appropriateness of restraint use (p<0.01). Nursing staff with longer clinical experience showed a more negative attitude towards restraint use than nursing staff with less experience (p<0.05) and charge nurses had the least positive attitude towards restraint use (p<0.05). Opinions regarding restraint measures differed between the three countries. The use of bilateral bedrails was considered as a moderate restrictive measure; the use of belts was rated as the most restrictive measure and nursing staff expressed pronounced discomfort on the use of these measures. CONCLUSIONS Nursing staff from three European countries have different attitudes and opinions regarding the use of physical restraints. The results underline the importance of more tailored, culturally sensitive interventions to reduce physical restraints in nursing homes.

MAPPIN'SDM – The Multifocal Approach to Sharing in Shared Decision Making

Background The wide scale permeation of health care by the shared decision making concept (SDM) reflects its relevance and advanced stage of development. An increasing number of studies evaluating the efficacy of SDM use instruments based on various sub-constructs administered from different viewpoints. However, as the concept has never been captured in operable core definition it is quite difficult to link these parts of evidence. This study aims at investigating interrelations of SDM indicators administered from different perspectives. Method A comprehensive inventory was developed mapping judgements from different perspectives (observer, doctor, patient) and constructs (behavior, perception) referring to three units (doctor, patient, doctor-patient-dyad) and an identical set of SDM-indicators. The inventory adopted the existing approaches, but added additional observer foci (patient and doctor-patient-dyad) and relevant indicators hitherto neglected by existing instruments. The complete inventory comprising a doctor-patient-questionnaire and an observer-instrument was applied to 40 decision consultations from 10 physicians from different medical fields. Convergent validities were calculated on the basis of Pearson correlation coefficients. Results Reliabilities for all scales were high to excellent. No correlations were found between observer and patients or physicians neither for means nor for single items. Judgements of doctors and patients were moderately related. Correlations between the observer scales and within the subjective perspectives were high. Inter-perspective agreement was not related to SDM performance or patient activity. Conclusion The study demonstrates the contribution to involvement made by each of the relevant perspectives and emphasizes the need for an inter-subjective approach regarding SDM measurement.