Anke Steckelberg

What constitutes evidence-based patient information? Overview of discussed criteria

OBJECTIVE To survey quality criteria for evidence-based patient information (EBPI) and to compile the evidence for the identified criteria. METHODS 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 criterion. Only studies on health issues with cognitive outcome measures were included. Evidence for each criterion is presented using descriptive methods. RESULTS 3 systematic reviews, 24 randomized-controlled studies and 1 non-systematic review were included. Presentation of numerical data, verbal presentation of risks and diagrams, graphics and charts are based on good evidence. Content of information and meta-information, loss- and gain-framing and patient-oriented outcome measures are based on ethical guidelines. There is a lack of studies on quality of evidence, pictures and drawings, patient narratives, cultural aspects, layout, language and development process. CONCLUSION The results of this review allow specification of EBPI and may help to advance the discourse among related disciplines. Research gaps are highlighted. PRACTICE IMPLICATIONS Findings outline the type and extent of content of EBPI, guide the presentation of information and describe the development process.

Effect of evidence based risk information on “informed choice” in colorectal cancer screening: randomised controlled trial

Objective To compare the effect of evidence based information on risk with that of standard information on informed choice in screening for colorectal cancer. Design Randomised controlled trial with 6 months’ follow-up. Setting German statutory health insurance scheme. Participants 1577 insured people who were members of the target group for colorectal cancer screening (age 50-75, no history of colorectal cancer). Interventions Brochure with evidence based risk information on colorectal cancer screening and two optional interactive internet modules on risk and diagnostic tests; official information leaflet of the German colorectal cancer screening programme (control). Main outcome measure The primary end point was “informed choice,” comprising “knowledge,” “attitude,” and “combination of actual and planned uptake.” Secondary outcomes were “knowledge” and “combination of actual and planned uptake.” Knowledge and attitude were assessed after 6 weeks and combination of actual and planned uptake of screening after 6 months. Results The response rate for return of both questionnaires was 92.4% (n=1457). 345/785 (44.0%) participants in the intervention group made an informed choice, compared with 101/792 (12.8%) in the control group (difference 31.2%, 99% confidence interval 25.7% to 36.7%; P<0.001). More intervention group participants had “good knowledge” (59.6% (n=468) v 16.2% (128); difference 43.5%, 37.8% to 49.1%; P<0.001). A “positive attitude” towards colorectal screening prevailed in both groups but was significantly lower in the intervention group (93.4% (733) v 96.5% (764); difference −3.1%, −5.9% to −0.3%; P<0.01). The intervention had no effect on the combination of actual and planned uptake (72.4% (568) v 72.9% (577); P=0.87). Conclusions Evidence based risk information on colorectal cancer screening increased informed choices and improved knowledge, with little change in attitudes. The intervention did not affect the combination of actual and planned uptake of screening. Trial registration Current Controlled Trials ISRCTN47105521.

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. HbA1c 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.

Ebm@school--a curriculum of critical health literacy for secondary school students: results of a pilot study.

Objectives:Increasingly, patients and consumers are taking responsibility for their diagnostic and therapeutic decisions. This requires a certain amount of health literacy in order to critically assess the various procedures and products. The aim of this study was to develop and pilot test a curriculum of critical health literacy for secondary school students.Methods:The curriculum is based on the concept of evidence-based medicine and consists of six modules. Development and pilot testing was performed with two classes of secondary school students (n = 45) in Grade 11. The Metaplan method was used to document feedback regarding teaching methods, worksheets, satisfaction and individually perceived benefits. Additionally, systematic observations by researchers were documented and students’ presentations assessed. A sample of untrained students (n = 218) served as a control group. The Critical Health Competency Test was employed for evaluating competencies in critical health literacy. Data were analyzed qualitatively and person parameters were calculated.Results:Overall, the pilot courses were well-accepted and have been proven to be feasible. Students’ feedback guided revision of the curriculum. Trained students achieved significantly higher person parameters (± SD) than the control group: 597 (± 79) versus 483 (± 94), p < 0.01, indicating enhancement of critical health competencies.Conclusion:Teaching critical health literacy to secondary school students is feasible and is likely to enhance the competence of critical health literacy. Further studies are needed to show the effectiveness of the intervention.

Blood glucose testing and primary prevention of diabetes mellitus type 2 - evaluation of the effect of evidence based patient information

BackgroundEvidence-based patient information (EBPI) has been recognised as important tool for informed choice in particular in the matter of preventive options. An objective, on the best scientific evidence-based consumer information about subthreshold elevated blood glucose levels (impaired fasting glucose and impaired glucose tolerance) and primary prevention of diabetes, is not available yet. Thus we developed a web-based EBPI and aim to evaluate its effects on informed decision making in people 50 years or older.Methods/DesignWe conduct a web-based randomised-controlled trial to evaluate the effect of information about elevated blood glucose levels and diabetes primary prevention on five specific outcomes: (i) knowledge of elevated blood glucose level-related issues (primary outcome); (ii) attitudes to a metabolic testing; (iii) intention to undergo a metabolic testing; (iv) decision conflict; (v) satisfaction with the information. The intervention group receives a specially developed EBPI about subthreshold elevated blood glucose levels and diabetes primary prevention, the control group information about this topic, available in the internet.The study population consists of people between 50 and 69 years of age without known diabetes. Participants will be recruited via the internet page of the cooperating health insurance company, Techniker Krankenkasse (TK), and the internet page of the German Diabetes Centre. Outcomes will be measured through online questionnaires. We expect better informed participants in the intervention group.DiscussionThe design of this study may be a prototype for other web-based prevention information and their evaluation.Trial registrationCurrent Controlled Trial: ISRCTN22060616.

Explaining computation of predictive values: 2 × 2 table versus frequency tree. A randomized controlled trial [ISRCTN74278823]

BackgroundInvolving patients in decision making on diagnostic procedures requires a basic level of statistical thinking. However, innumeracy is prevalent even among physicians. In medical teaching the 2 × 2 table is widely used as a visual help for computations whereas in psychology the frequency tree is favoured. We assumed that the 2 × 2 table is more suitable to support computations of predictive values.Methods184 students without prior statistical training were randomised either to a step-by-step self-learning tutorial using the 2 × 2 table (n = 94) or the frequency tree (n = 90). During the training session students were instructed by two sample tasks and a total of five positive predictive values had to be computed. During a follow-up session 4 weeks later participants had to compute 5 different tasks of comparable degree of difficulty without having the tutorial instructions at their disposal. The primary outcome was the correct solution of the tasks.ResultsThere were no statistically significant differences between the two groups. About 58% achieved correct solutions in 4–5 tasks following the training session and 26% in the follow-up examination.ConclusionsThese findings do not support the hypothesis that the 2 × 2 table is more valuable to facilitate the calculation of positive predictive values than the frequency tree.

Patient participation - What is it?

T p o r t t ( here are many different meanings of patients and particiation. Patients, especially in the Anglo-Saxon area, is often eferred to as users, sometimes as consumers. Also, patient egularly encompasses the participation of family members, arers or proxies. Others use the term patient and pubic. The public can be public patient groups, local patient etworks, patient advocate groups, self-help groups, Euroean patient organisations etc. The same for participation, hich is frequently used synonymously with involvement, ngagement or empowerment. Internationally, patient and ublic involvement (PPI) is a widely used term. We would like to use the definition of the European atient’s Forum as starting point for this section. They rite that patients take an active role in activities or ecisions that will have meaningful consequences for the atient and patient community, because of their specific nowledge and relevant experience as patients [1]. Howver, the European Patient’s Forum acknowledges that this s not a ready-made definition because meaningful differs cross patient(groups), countries and cultures. Most imporantly, the definition brings to the fore the contribution of xperience-based knowledge. It is based on the premise that atients have a specific expertise derived from simply being atients. Patients’ experience-based knowledge is derived rom living with a health condition day-to-day and from eing in frequent contact with the healthcare system. This akes it different from lay people and healthy consumers. In a recent paper the Europeans Patient’s Forum [1] disinguishes individual and collective patient participation: hey state that individual participation is the extent to hich patients and their families or informal caregivers, henever appropriate, participate in decisions related o their condition (e.g. through shared decision-making, atient preferences, selfmanagement) and contribute to rganisational learning through their specific experience s patients. Collective participation they describe as the xtent to which patients, through their representative rganisations, contribute to shaping the health care system hrough involvement in health care policy-making, organisaion, design and delivery, as well as guideline development. Levels of meaningful involvement are often illustrated y the ladder-model developed by Sherry Arnstein [2]. The t p i d

Evidence-based health information and risk competence.

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, whereas harm is often underestimated. Evidence-based health information has to fulfil certain criteria, for instance, it should be evidence-based, independent, complete, true as well as understandable. The aim of a medical intervention has to be explained. The different therapeutic options including the option not to intervene have to be delineated. The probabilities for success, lack of success and unwanted side effects have to be communicated in a numerical and understandable manner. Patients have the right to reject medical interventions without any sanctions.

Impact of numerical information on risk knowledge regarding human papillomavirus (HPV) vaccination among schoolgirls: a randomised controlled trial.

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 ability to deal with numerical data is low, especially in disadvantaged pupils. The aim of the present study was to compare the effects of a standard leaflet with an information leaflet supplemented with numerical data on ‘risk knowledge’ regarding HPV vaccination among schoolgirls. Methods: Randomised-controlled short-term trial. All 108 schoolgirls of seven school classes were asked to participate and 105 agreed. Participants were vocational schoolgirls who were preparing for grade 10 graduation and who were members of the target group for HPV vaccination. The control group was asked to read a standard leaflet on HPV vaccination of the German Women’s Health Network. The intervention group received the same leaflet, but it was supplemented with numerical information on cancer risk and assumed effects of the HPV vaccination on cancer prevention. As baseline characteristics we surveyed: age, vaccination status, attitude towards HPV vaccination and aspects regarding migration background. The primary end point was ‘risk knowledge’. Questionnaire surveys were performed under experimental conditions. Individual randomisation, participants, and intention-to-treat data analyses were blinded. The study was approved by the Ministry of Education and Culture of Schleswig-Holstein and the ethics committee of the Hamburg Chamber of Physicians. Results: We analysed ‘risk knowledge’ for all 105 randomised participants. Baseline characteristics of the two groups were comparable. Numerical risk information recipients were more likely to give correct answers compared to standard information recipients: Mean value of risk knowledge score (0–5 points): 4.6±1.0 vs. 2.6±1.2 (mean difference 2.0 (95% CI 1.6–2.4)); (P<0.001). Post hoc distractor analysis of single items was performed. Incorrect answers of control participants indicated that cervical cancer risk was highly overestimated whereas total cancer risk was mostly underestimated, and possible impact of HPV vaccination on cancer prevention was overestimated. Conclusion: Supplementing health information on HPV vaccination with numerical data improves ‘risk knowledge’ among schoolgirls.

The quality of informed consent forms

BACKGROUND The patients 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 evidence on the quality and efficacy of informed consent forms. The definition of criteria for the evaluation of meta-information, content, and presentation were derived from current guidelines for evidence-based health information. As an example, we analyzed consent forms currently in use in Germany for 10 medical interventions with regard to decisionally relevant content and intelligibility of format. RESULTS Our literature search yielded 14 content analyses, which revealed that even some of the more important evaluative criteria were not always met, including information on benefits (9/14), risks (14/14), alternatives (11/14), the option of doing nothing (6/14), and numerical frequencies (2/14). All analyses indicated deficiencies in the content of the consent forms. We then analyzed 37 consent forms obtained from publishing companies (across Germany) and physicians practices in Hamburg. These forms were found to contain information on: the intervention (37/37), benefits (30/37), risks (37/37), alternatives (26/37), the option of doing nothing (4/37), numerical frequencies (10/37), the names of the authors (17/37), sources of information (0/37), and date of issue (21/37). CONCLUSION Both the evidence from foreign countries and our own analysis of the consent forms now in use in Germany revealed deficiencies, particularly in the communication of risks. New standards are needed to promote well-informed decision-making. Structural changes in the process of patient information and decision-making should be discussed.