Ingrid Mühlhauser

• MD, PHD
• Head of Department at Hamburg University

Treatment of patients with type 2 diabetes aims to avoid acute symptoms of hyperglycemia and to prevent macro- and microvascular complications. In recent years, the number of glucose-lowering drugs increased to unprecedented levels. The American Diabetes Association (ADA) lists seven drug classes of available glucose-lowering agents in the last edi...

Treatment of patients with type 2 diabetes aims to avoid acute symptoms of hyperglycemia and to prevent macro- and microvascular complications. In recent years, the number of glucose-lowering drugs increased. All are proven to decrease HbA1c levels or postprandial glucose excursions, but evidence on patient-relevant outcomes, such as cardiovascular...

Background Shared decision-making in oncology requires information on individual prognosis. This comprises cancer prognosis as well as competing risks of dying due to age and comorbidities. Decision aids usually do not provide such information on competing risks. We conducted an overview on clinical prediction tools for early breast cancer and deve...

Background: Women with breast cancer demand informed shared decision-making. Guidelines support these claims. Objectives: To investigate whether an informed shared decision-making intervention for women with 'ductal carcinoma in situ' comprising an evidence-based decision aid with nurse-led decision coaching enhances the extent of the mutual sha...

Objective To translate an informed shared decision-making programme (ISDM-P) for patients with type 2 diabetes from a specialised diabetes centre to the primary care setting. Design Patient-blinded, two-arm multicentre, cluster randomised controlled trial of 6 months follow-up; concealed randomisation of practices after patient recruitment and acq...

Background Current German and EU package leaflets (PLs) do not distinguish to what extent listed side effects are indeed side effects caused by drug intake or instead symptoms that occur regardless of drug use. We recently showed that most health professionals misinterpret the frequencies of listed side effects as solely caused by the drug. The pre...

PubMed search strategy. (PDF)

Format 2: Alternative package leaflet (intervention): Drug facts box with reading instruction. (PDF)

Format 4: Standard package leaflet (Control). (PDF)

Format 2: Drug facts box with reading instruction (Original language). (PDF)

Format 3: Narratives with numbers (Original language). (PDF)

Distribution of participants’ responses on the general occurrence of side effects during drug intake for each format. (PDF)

Effect of the order of the question of causality on the proportion of participants’ correct responses in dependence on whether participants first received the question on causality and then the question on general occurrence or vice versa occurrence and then the question on causality or vice versa. (PDF)

Consent form and introduction to the survey. (PDF)

Format 1: Drug facts box (Original language). (PDF)

Excerpt from Barron et al.: The proportion of side-effects on beta-blocker that are caused by being on beta-blocker. (PDF)

Distribution of participants’ responses on the causal relation between drug intake and side effects for each format. (PDF)

Format 1: Alternative package leaflet (intervention): Drug facts box. (PDF)

Format 3: Alternative package leaflet (intervention): Narrative with numbers. (PDF)

Format 4: Standard package leaflet (Original language). (PDF)

Effect of the order of the question of general occurrence on the proportion of participants’ correct responses in dependence on whether participants first received the question on general. (PDF)

Background: The patient's consent to a medical procedure must be preceded by a pre-procedure discussion with the physician that is documented on a standardized form. Evidence suggests that these forms lack information that would be relevant for an informed decision. Methods: We carried out a systematic literature search up to February 2017 for e...

Background Media frequently draws inappropriate causal statements from observational studies. We analyzed the reporting of study results in the Medical News section of the German medical journal Deutsches Ärzteblatt (DÄ). Methods Study design: Retrospective quantitative content analysis of randomly selected news reports and related original journa...

Background People living with dementia are often appointed a legal representative, to support and protect their ethical and legal rights to informed healthcare decisions. However, legal representatives usually have no qualifications in healthcare. Objective The aim of this study was to explore decision-making processes with participation of legal...

Background To implement informed shared decision-making (ISDM) in breast care centres, we developed and piloted an inter-professional complex intervention. Methods We developed an intervention consisting of three components: an evidence-based patient decision aid (DA) for women with ductal carcinoma in situ, a decision-coaching led by specialised...

Background In Germany, the guardianship system provides adults who are no longer able to handle their own affairs a court-appointed legal representative, for support without restriction of legal capacity. Although these representatives only rarely are qualified in healthcare, they nevertheless play decisive roles in the decision-making processes fo...

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...

Background Presentation of confidence intervals alongside information about treatment effects can support informed treatment choices in people with multiple sclerosis.We aimed to develop and pilot-test different written patient information materials explaining confidence intervals in people with relapsing-remitting multiple sclerosis. Further, a qu...

Background: Patients can only make well-informed decisions if the information they are given by health professionals is based on scientific evidence. In this study, we assessed the foundation in evidence of free, publicly available telephone consultations in Germany. Methods: From March 2013 to January 2014, four hidden clients seeking information...

Background Women with breast cancer want to participate in treatment decision-making. Guidelines have confirmed the right of informed shared decision-making. However, previous research has shown that the implementation of informed shared decision-making is suboptimal for reasons of limited resources of physicians, power imbalances between patients...

Consumers and patients want to be included in decisions regarding their own health and have an ethically justified claim on informed decisions. Therefore, sound information is required, but health information is often misleading and based on different interests. The risks of disease and the benefits of medical interventions tend to be overestimated...

Background Both pharmacological and non-pharmacological preventive interventions can do more harm than good. Health checks target a healthy or symptomless population. This is why randomised controlled trials (RCTs) must be conducted to provide high-quality evidence for the benefit of an intervention. The present article presents examples to demonst...

Consumers and patients want to participate in making decisions related to their health. They have an ethical right to make informed decisions. Evidence-based information is an indispensable prerequisite for informed decision making. However, health information is frequently biased and misleading. Disease-related health risks and the benefits of med...

Background Educational practice is characterised by fashion, myths und traditions. Studies examining the efficacy of educational interventions are rare. Objective We studied which educational interventions in the field of education and training have been evaluated in randomised controlled trials (RCTs) during the past three years. Methods Systema...

The recently revised German transplantation law provides that people are to be supported to make informed decisions on post-mortem organ donation by implementing broad education campaigns. A comprehensive web-based decision aid "organ donation after death" was developed, evaluated and optimised utilising multiple methodological phases. The decision...

Acknowledgment of all serious limitations to research evidence is important for patient care and scientific progress. Formal research on how biomedical authors acknowledge limitations is scarce. To assess the extent to which limitations are acknowledged in biomedical publications explicitly, and implicitly by investigating the use of phrases that e...

Lack of patient involvement in decision making has been suggested as one reason for limited treatment success. Concepts such as shared decision making may contribute to high quality healthcare by supporting patients to make informed decisions together with their physicians.A multi-component shared decision making programme on the prevention of hear...

Introduction: In Germany the implementation of human papillomavirus (HPV) vaccination for women aged 12-17 years was accompanied by various campaigns. Evidence-based information including numerical data was not provided. However, standard information leads to overestimation of cancer risk and effects of HPV vaccination. Confidence in children's ab...

This is the protocol for a review and there is no abstract. The objectives are as follows: To assess the effects of oral health educational interventions for nursing home staff and residents to maintain or improve the oral health of nursing home residents. To describe the components of the complex interventions used in the included studies.

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 Gmünde...

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 par...

Informed and shared decision-making require competences for both partners - healthcare professionals and patients. There is a lack of training courses in evidence-based medicine for patients and counsellors. We investigated feasibility, acceptability and the potential effects of a 2 x 2.5 days training course on critical health competences in patie...

Educational practice is characterised by fashion, myths und traditions. Studies examining the efficacy of educational interventions are rare. We studied which educational interventions in the field of education and training have been evaluated in randomised controlled trials (RCTs) during the past three years. Systematic searches were conducted in...

The recently revised German transplantation law provides that people are to be supported to make informed decisions on post-mortem organ donation by implementing broad education campaigns. A comprehensive web-based decision aid “organ donation after death” was developed, evaluated and optimised utilising multiple methodological phases. The decision...

In Reply: Our study provided convincing evidence that nursing home care can be conducted safely with fewer physical restraints. Because the study was powered to detect a relevant reduction of any physical restraint (primary outcome), it cannot be concluded that the intervention had no effect on the use of waist belts in beds because this would have...

Patients want to be more involved in medical decision-making. To this end, some decision aids are now available. We present an overview of this subject, in which we explain the terms "shared decision-making", "decision aid", and "evidence-based patient information" and survey information on the available decision aids in German and other languages...

Despite unambiguous legal regulation and evidence for lack of effectiveness and safety, physical restraints are still frequently administered in nursing homes. To reduce physical restraint prevalence in nursing homes using a guideline- and theory-based multicomponent intervention. Cluster randomized controlled trial of 6 months' duration conducted...

Background Many medical interventions are of a complex nature. They comprise interdependent components differently interacting within various complex settings, e.g., stroke units. Appraising the efficacy, benefit and harm of complex interventions is far more difficult than appraising single interventions like specific drug treatments. Detailed meth...

Objective: Statistical health risk information has been proven confusing and difficult to understand. While existing research indicates that presenting risk information in frequency formats is superior to relative risk and probability formats, the optimal design of frequency formats is still unclear. The aim of this study was to compare presentatio...

To compare the effect of evidence based information on risk with that of standard information on informed choice in screening for colorectal cancer. Randomised controlled trial with 6 months' follow-up. German statutory health insurance scheme. 1577 insured people who were members of the target group for colorectal cancer screening (age 50-75, no h...

Die Steigerung von Patientenkompetenz kann unmittelbar gesundheitliche Erfolge zeigen. „Mehr Raum für Eigensinn“ fordert deshalb Bettina Berger, Initiatorin und Organisatorin einer Tagung zur Patientenkompetenz und Herausgeberin des vorliegenden Buches. Eigensinn bedeutet hier Raum für eigene Deutungen der Krankheit, mehr Zeit für Therapieentscheid...

Zusammenfassung Der Glaube an den uneingeschränkten Nutzen von Prävention ist ungebrochen. Forderungen nach Sanktionen gegen Fettleibige, Bewegungsmuffel und Vorsorgeverweigerer sind allgegenwärtig. Krankheit gilt als fehlender Wille zu Eigenverantwortung. Erwachsene, die nicht mindestens einmal pro Jahr den Zahnarzt aufsuchen, müssen schon seit l...

Many medical interventions are of a complex nature. They comprise interdependent components differently interacting within various complex settings, e.g., stroke units. Appraising the efficacy, benefit and harm of complex interventions is far more difficult than appraising single interventions like specific drug treatments. Detailed methodological...

There is no lack of health information material for patients and the public. However, the quality of the material is poor and it cannot be used for informed or shared decision making. Usually the information is biased, incomplete, and persuasive. Patient representatives in Germany and Europe demand a change of the information process. They want evi...

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. T...

Einleitung Irreführende Patienteninformationen sind die Regel. Sie werden systematisch genutzt, um gesundheitsorientierte Maßnahmen umzusetzen. Sie können zu schwerwiegenden Trugschlüssen führen. Irreführung entsteht durch Unvollständigkeit der Information und missverständliche Präsentation von Daten. Den Bürgern fehlt die notwendige kritische Gesu...

So far there has been no consensus on the criteria which confirmthe validity of scientific contributions in conventional medicine(CM) and complementary/ alternative medicine (CAM). An interdisciplinarygroup of experts from various disciplines within each of the areas of medicine held six well-documented sessions in an effort toreach a consensus. Th...

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...

Curriculum. Structure, specific objectives, topics, materials, and methods of the evidence-based medicine (EBM) training courses

Examples of implementation. Examples of successful implementation as reported by participants

Evidence-based medicine (EBM) has become standard approach in medicine. Patients and health authorities increasingly claim active patient roles in decision making. Education to cope with these roles might be useful. We investigated the feasibility, acceptability and possible impact of EBM training courses for patient and consumer representatives. W...

Zu dem Workshop sind 20 bis 25 Teilnehmer eingeladen. Ziel Kurzbeiträge, die das Problem der Zielgruppen-spezifischen Schmerzerfassung und Therapie eröffnen, gefolgt von zwei provokativen Positionsstatements. Die Teilnehmer werden gebeten, sich Fragen und Anmerkungen zu notieren und beteiligen sich nach den kurzen Beiträgen am moderierten Diskurs....

To survey quality criteria for evidence-based patient information (EBPI) and to compile the evidence for the identified criteria. Databases PubMed, Cochrane Library, PsycINFO, PSYNDEX and Education Research Information Center (ERIC) were searched to update the pool of criteria for EBPI. A subsequent search aimed to identify evidence for each criter...

Aims: Development and testing of a decision aid about prevention of myocardial infarction for persons with type 2 diabetes. Methods: Development and testing were guided by the UK Medical Research Council’s guidance for the development and evaluation of complex interventions. This comprised a systematic literature review, a focus group of 9 potentia...

Physical restraints are regularly applied in German nursing homes. Their frequency varies substantially between centres. Beneficial effects of physical restraints have not been proven, however, observational studies and case reports suggest various adverse effects. We developed an evidence-based guidance on this topic. The present study evaluates t...

Overweight and obesity are generally thought to elevate morbidity and mortality. New data call this supposed association into question. The Cochrane, Pubmed, and other databases were systematically searched for a combination of relevant terms and subject headings. Meta-analyses and cohort studies based on the German population were evaluated for po...

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...

the impact of fall risk assessment tools on clinical endpoints is unknown. we compared a standardised fall risk assessment tool alongside nurses' clinical judgement with nurses' judgement alone. a 12-month cluster-randomised controlled trial. nursing homes in Hamburg (29 per study group). 1,125 residents (n = 574 intervention group, IG; n = 551 con...

To investigate (1) the prevalence of physical restraints and psychoactive medication, (2) newly administered physical restraints, frequency of application of the devices and frequency of psychoactive medication on demand during 12-month follow-up and (3) characteristics associated with restraint use in nursing homes. High quality data on restraint...