[Development of Decision Aids for Organized Cervical Carcinoma Screening in Germany]. / Entwicklung von Entscheidungshilfen für das organisierte Zervixkarzinom-Screening in Deutschland.

AIM OF THE STUDY: The Federal Joint Committee has decided to introduce organized cervical carcinoma screening in 2020. The present work describes the development of decision aids that will be sent to women in this program. METHODS: A systematic search for qualitative studies and surveys was conducted to gather information on experiences, attitudes and information needs. Furthermore, we searched for systematic reviews on advantages and disadvantages of screening. An existing decision analysis for cervical carcinoma screening in Germany was used. The designs were subjected to a qualitative test (focus groups with 26 women and 8 expert interviews), to a quantitative user test (online survey n=2,014 women) and to a public hearing. RESULTS: Most women found the decision aids informative and helpful. The majority would recommend the use of these materials to others. For many women, part of the information was new, although they had been involved in cervical cancer screening for some time. The presentation of the advantages and disadvantages was judged to be balanced. However, 10% changed their attitude towards participation and 70% of women would attend screening. CONCLUSION: The decision aids found a high acceptance among the users. They can help to reduce knowledge deficits on cervical carcinoma screening and support a informed decision making.

Communicating Uncertainty in Written Consumer Health Information to the Public: Parallel-Group, Web-Based Randomized Controlled Trial.

BACKGROUND: Uncertainty is integral to evidence-informed decision making and is of particular importance for preference-sensitive decisions. Communicating uncertainty to patients and the public has long been identified as a goal in the informed and shared decision-making movement. Despite this, there is little quantitative research on how uncertainty in health information is perceived by readers. OBJECTIVE: The aim of this study was to examine the impact of different uncertainty descriptions regarding the evidence for a treatment effect in a written research summary for the public. METHODS: We developed 8 versions of a research summary on a fictitious drug for tinnitus with varying degrees (Q1), sources (Q2), and magnitudes of uncertainty (Q3). We recruited 2099 members of the German public from a web-based research panel. Of these, 1727 fulfilled the inclusion criteria and were randomly presented with one of these research summaries. Randomization was conducted by using a centralized computer with a random number generator. Web-based recruitment and data collection were fully automated. Participants were not aware of the purpose of the study and alternative presentations. We measured the following outcomes: perception of the treatment effectiveness (primary), certainty in the judgement of treatment effectiveness, perception of the body of evidence, text quality, and intended decision. The outcomes were self-assessed. RESULTS: For the primary outcome, we did not find a global effect for Q1 and Q2 (P=.25 and P=.73), but we found a global effect for Q3 (P=.048). Pairwise comparisons showed a weaker perception of treatment effectiveness for the research summary with 3 sources of uncertainty compared to the version with 2 sources of uncertainty (P=.04). Specifically, the proportion of the participants in the group with 3 sources of uncertainty that perceived the drug as possibly beneficial was 9% lower than that of the participants in the group with 2 sources of uncertainty (92/195, 47.2% vs 111/197, 56.3%, respectively). The proportion of the participants in the group with 3 sources of uncertainty that considered the drug to be of unclear benefit was 8% higher than that of the participants in the group with 2 sources of uncertainty (72/195, 36.9% vs 57/197, 28.9%, respectively). However, there was no significant difference compared to the version with 1 source of uncertainty (P=.31). We did not find any meaningful differences between the research summaries for the secondary outcomes. CONCLUSIONS: Communicating even a large magnitude of uncertainty for a treatment effect had little impact on the perceived effectiveness. Efforts to improve public understanding of research are needed to improve the understanding of evidence-based health information. TRIAL REGISTRATION: German Clinical Trials Register DRKS00015911, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015911. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/13425.

Words or numbers? Communicating risk of adverse effects in written consumer health information: a systematic review and meta-analysis.

BACKGROUND: Various types of framing can influence risk perceptions, which may have an impact on treatment decisions and adherence. One way of framing is the use of verbal terms in communicating the probabilities of treatment effects. We systematically reviewed the comparative effects of words versus numbers in communicating the probability of adverse effects to consumers in written health information. METHODS: Nine electronic databases were searched up to November 2012. Teams of two reviewers independently assessed studies. INCLUSION CRITERIA: randomised controlled trials; verbal versus numerical presentation; context: written consumer health information. RESULTS: Ten trials were included. Participants perceived probabilities presented in verbal terms as higher than in numeric terms: commonly used verbal descriptors systematically led to an overestimation of the absolute risk of adverse effects (Range of means: 3% - 54%). Numbers also led to an overestimation of probabilities, but the overestimation was smaller (2% - 20%). The difference in means ranged from 3.8% to 45.9%, with all but one comparison showing significant results. Use of numbers increased satisfaction with the information (MD: 0.48 [CI: 0.32 to 0.63], p < 0.00001, I2 = 0%) and likelihood of medication use (MD for very common side effects: 1.45 [CI: 0.78 to 2.11], p = 0.0001, I2 = 68%; MD for common side effects: 0.90 [CI: 0.61 to 1.19], p < 0.00001, I2 = 1%; MD for rare side effects: 0.39 [0.02 to 0.76], p = 0.04, I2 = not applicable). Outcomes were measured on a 6-point Likert scale, suggesting small to moderate effects. CONCLUSIONS: Verbal descriptors including "common", "uncommon" and "rare" lead to an overestimation of the probability of adverse effects compared to numerical information, if used as previously suggested by the European Commission. Numbers result in more accurate estimates and increase satisfaction and likelihood of medication use. Our review suggests that providers of consumer health information should quantify treatment effects numerically. Future research should focus on the impact of personal and contextual factors, use representative samples or be conducted in real life settings, measure behavioral outcomes and address whether benefit information can be described verbally.

Communicating Uncertainty From Limitations in Quality of Evidence to the Public in Written Health Information: Protocol for a Web-Based Randomized Controlled Trial.

BACKGROUND: Uncertainty is integral to evidence-informed decision making and is of particular importance for preference-sensitive decisions. Communicating uncertainty to patients and the public has long been identified as a goal in the informed and shared decision-making movement. Despite this, there is little quantitative research on how uncertainty in health information is perceived by readers. OBJECTIVE: The objective of this study is to design an experiment to examine how different degrees of uncertainty (Q1) and different types of uncertainty (Q2) impact patients' perception of treatment effectiveness, the body of evidence, text quality, and hypothetical treatment intention. The experiment also examines whether there is an additive effect when multiple sources of uncertainty are communicated (Q3). METHODS: We developed 8 variations of a research summary set in a hypothetical scenario for a treatment decision in the context of tinnitus. These were modified only in the degree of uncertainty relating to the evidence of the presented treatment. We recruited members of the German public from a Web-based research panel and randomized them to one of 8 variations of the research summary to examine the 3 research questions. The trial was only open to the members of the research panel. The outcomes are perception of the effectiveness of the treatment (primary), certainty in the judgement of treatment effectiveness, perception of the body of evidence relating to the treatment, text quality, and decisional intention (secondary). Outcomes were self-assessed. We aimed to recruit 1500 participants to the trial. The recruitment and data collection was fully automated. Ethical approval was waivered by an ethics committee because of the negligible risk to participants. RESULTS: This protocol is retrospectively published in its original format. In the meantime, the trial was set up and the data collection was completed. Data collection was conducted in May 2018. A total of 1727 eligible panel members were enrolled. CONCLUSIONS: We aim to publish the results in a peer-reviewed journal by the end of 2019. In addition, results will be presented at conferences and disseminated among developers of guidance for the development of evidence-based health information and decision aids. TRIAL REGISTRATION: German Clinical Trials Register DRKS00015911; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00015911 (Archived by WebCite at http://www.webcitation.org/77zyZTGzk). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13425.

Climbing for preventing and treating health problems: a systematic review of randomized controlled trials.

OBJECTIVE: To summarize the best available evidence on effectiveness of therapeutic or sport climbing in preventing or treating health problems. METHODS: We searched Medline, Embase, CENTRAL, PsycINFO, PEDro, OTseeker and SportDiscus for randomized controlled trials published up to December 26, 2010. We included all trials assessing patient-relevant outcomes. Two reviewers independently selected relevant studies, assessed their methodological quality and extracted data. Quality of evidence was rated using the GRADE system. Data were entered into RevMan 5 to calculate effect sizes and 95% confidence intervals where appropriate. RESULTS: Eligible for inclusion were four RCTs studying the effectiveness of climbing in (a) geriatric patients, (b) adults with multiple sclerosis, (c) adults with chronic low-back pain and (d) children with disabilities and poor motor function. The sample sizes ranged between 20 and 95. All trials had major methodological limitations. We found very low quality evidence that therapeutic climbing may improve activities of daily living in geriatric patients compared to physiotherapy as measured by the Barthel index (difference in mean change score: 2.32 [95%-CI: 0.45 to 4.19]). We found very low quality evidence that therapeutic climbing compared to standard exercise therapy may improve physical functioning (difference in mean change score: 16.15 [95%-CI: 4.45 to 27.85]) and general physical health (13.14 [95%-CI: 3.61 to 22.67]) as measured by the SF-36 in adults with chronic low back-pain. CONCLUSIONS: Evidence for the effectiveness of therapeutic climbing is limited to small trials at high risk of bias. The effects of therapeutic climbing are therefore unclear.

[Online surveys at www.gesundheitsinformation.de: identifying the potential need for evidence-based health information]. / Online-Umfragen auf Gesundheitsinformation.de: Ermittlung potenzieller Informationsbedürfnisse für evidenzbasierte Gesundheitsinformationen.

There is some evidence that involving patients in the development of health information can increase the relevance and understandability of this information. The German Institute for Quality and Efficiency in Health Care (IQWiG) publishes easy-to-understand and freely accessible evidence-based health information on its bilingual website gesundheitsinformation.de / informedhealthonline.org. The aim of the Institute is to determine the information needs of the general public and patients, and to take those needs into account when producing its health information. One way in which this is done is by carrying out online surveys before the information is produced, asking the users of the website about their level of interest in various aspects of a topic. In this article we present two examples of such surveys - on the topics of "endometriosis" and "skin cancer screening and prevention" - as well as the results of these surveys and how the results influenced the contents of the health information produced. Our experience with a total of seven surveys suggests that online surveys can be a helpful additional tool to identify information gaps and determine information needs and areas of special interest. In addition, surveys provide a way to interact with the users of the website. In their current form, however, online surveys also have methodological limitations that need to be considered when developing these surveys and interpreting their results.