Attributes Characterizing Colorectal Cancer Screening Tests That Influence Preferences of Individuals Eligible for Screening in Germany: A Qualitative Study.

Purpose: This qualitative study is part of the SIGMO study, which evaluates general populations' preferences for colorectal cancer (CRC) screening in Germany using a discrete choice experiment. Attribute identification and selection are essential in the construction of choice tasks and should be evidence-based ensuring that attributes are relevant to potential beneficiaries and contribute to overall utility. Therefore, this qualitative study aims to identify relevant attributes characterizing CRC screening tests from the perspective of those eligible for screening in Germany. Patients and Methods: Individuals aged 50 to 60 were purposively selected. A questioning route was developed and piloted. Four focus groups (FG) (n=20) were conducted (November 2019) with two moderators and one observer each. FGs were audio recorded, transcribed, and analyzed using qualitative content analysis. Attributes were deductively assigned based on a priori identified attribute categories, and inductively derived. Results: Across FGs, 24 attributes (n=293 codes) were discussed, five of which (sedation, inability to work, transportation home, predictive values, waiting time for screening colonoscopy) were inductively derived (n=76 codes). Four attributes identified a priori were not addressed in any FG. The most frequently discussed attribute category was procedural characteristics, followed by measures of screening test validity, benefits, harms, and structural characteristics of health care. The most commonly addressed attributes were preprocedural bowel cleansing, kind of procedure, and predictive values. Conclusion: Newly identified attributes characterizing CRC screening tests from an individual's perspective, and a priori identified attributes not addressed by any FG stress the added value of qualitative research and thereby the importance of applying a mix of methods in identifying and selecting attributes for the construction of choice tasks. This study meets the requirements for a transparent and detailed presentation of the qualitative methods used in this process, which has rarely been the case before.

Quality of life and fear of disease progression are associated with aspects of health literacy in men with prostate cancer from Germany.

PURPOSE: Our research aimed to identify whether specific aspects of health literacy (HL) are associated with quality of life (QOL) and fear of progression (FOP) in men with prostate cancer (PC). METHODS: We conducted a cross-sectional study. Regarding HL, we surveyed communication skills, guideline awareness, and knowledge in several domains: PC, health care system, own physical condition, dealing with health problems. Research questions were addressed using regression models for QOL and FOP including sociodemographic and disease-related variables as additional predictors. RESULTS: One thousand five hundred seventy-seven men completed the questionnaire. Better QOL was statistically significant associated with communication skills (OR 2.24; CI 1.57-3.21), knowledge of dealing with health problems (OR 2.54; CI 1.74-3.72), and knowledge of own physical condition (OR 0.63; CI 0.42-0.95). FOP decreased with increasing communication skills (ß - 0.09; CI - 0.15 to - 0.04), knowledge of health care system (ß - 0.07; CI - 0.12 to - 0.02), and knowledge of dealing with health problems (ß - 0.21; CI - 0.27 to - 0.15). It increased with guideline awareness (ß 0.07; CI 0.02-0.11), PC knowledge (ß 0.11; CI 0.06-0.16), and knowledge about own physical condition (ß 0.11; CI 0.05-0.17). CONCLUSIONS: The findings lead to the hypothesis that some aspects of HL may have a positive and some a negative influence on men with PC. Men should not be overwhelmed by a recommendation for self-observation or by promotion of PC knowledge. Interventions are needed that provide knowledge for managing health problems. Communication in health care should be tailored to men's needs.

[Participation in self-help groups: impact on self-management and knowledge]. / Teilnahme an Selbsthilfegruppen: Wirkungen auf Selbstmanagement und Wissenserwerb.

BACKGROUND: Self-help groups (SHGs) are an inherent part of patient involvement and play an important role in the healthcare system. Until now, however, there has been a lack of systematic investigations and quantitative data about the individual impact of self-help for patients and relatives. OBJECTIVES: This study presents the results of a comparison between members of SHGs and non-members. Thereby, the effects of self-help shall be described in terms of empowerment and self-management. The study is part of the project "Health-related Collective Self-Help in Germany" (Gesundheitsbezogene Selbsthilfe in Deutschland-SHILD) funded by the Federal Ministry of Health. MATERIALS AND METHODS: The study was conducted with patients from five therapeutic areas (diabetes mellitus type 2, prostate cancer, multiple sclerosis, tinnitus, relatives of dementia patients). Participants administered a multidimensional questionnaire (paper-and-pencil or online). Of the 2870 participants in this analysis, 49% were active members of SHGs. RESULTS: Statistical analysis showed some significant, but small differences between the two groups in five out of seven scales of the Health Education Impact Questionnaire (heiQ) in favour of the SHG members. Furthermore, SHG members performed better in specific knowledge tests. Members see the importance of their group especially in social inclusion, psychosocial relief, coping with the disease and new insights in dealing with the disease. CONCLUSIONS: With respect to the study design we cannot rule out that differences might be based on personal characteristics influencing the decision to participate in a SHG or not. But as the results are controlled for confounders, the hypothesis that SHG participation has a positive impact on the outcomes rather than vice versa seems supported.

Participation in a prostate cancer support group and health literacy.

BACKGROUND: To cope with prostate cancer (PC) and its consequences and to be certain about therapeutic alternatives, some patients seek mutual help in prostate cancer support groups (PCSGs), where they share information and find social support. Our study was intended to assess whether group participation is associated with health literacy (HL). METHODS: We compared PCSG members (n = 441) with PC patients without support group experiences (n = 135) in a cross-sectional design. For this purpose, HL was operationalized through PC-specific knowledge, noncancer-specific knowledge about health care, guideline awareness, and skills needed to apply health information to meet own needs. Binary logistic regression models were calculated. Socio-demographic data and disease-related characteristics were used as control variables. RESULTS: Knowledge about PC (OR, 2.2; CI, 1.3-3.7), the fact of having heard of guidelines (OR, 3.7; CI, 2.1-6.8) and having read one (OR, 5.1; CI, 2.8-9.4), and competencies regarding health service navigation (OR, 1.8; CI, 1.0-3.1) are associated with PCSG membership. No statistically significant associations could be found between PCSG membership and further skills questioned, as well as between membership and knowledge about noncancer-specific health care. CONCLUSION: PCSG membership is associated with HL in some areas only. In particular, the groups seem to provide an important platform for information exchange in the field of PC. The potentially conflicting results on PC knowledge and the application skills may arise from the different forms of measurement-knowledge was tested; skills were self-assessed.

Ethics Literacy and "Ethics University": Two Intertwined Models for Public Involvement and Empowerment in Bioethics.

BACKGROUND: Informing lay citizens about complex health-related issues and their related ethical, legal, and social aspects (ELSA) is one important component of democratic health care/research governance. Public information activities may be especially valuable when they are used in multi-staged processes that also include elements of information and deliberation. OBJECTIVES: This paper presents a new model for a public involvement activity on ELSA (Ethics University) and evaluation data for a pilot event. METHODS: The Ethics University is structurally based on the "patient university," an already established institution in some German medical schools, and the newly developed concept of "ethics literacy." The concept of "ethics literacy" consists of three levels: information, interaction, and reflection. The pilot project consisted of two series of events (lasting 4 days each). RESULTS: The thematic focus of the Ethics University pilot was ELSA of regenerative medicine. In this pilot, the concept of "ethics literacy" could be validated as its components were clearly visible in discussions with participants at the end of the event. The participants reacted favorably to the Ethics University by stating that they felt more educated with regard to the ELSA of regenerative medicine and with regard to their own abilities in normative reasoning on this topic. CONCLUSION: The Ethics University is an innovative model for public involvement and empowerment activities on ELSA theoretically underpinned by a concept for "ethics literacy." This model deserves further refinement, testing in other ELSA topics and evaluation in outcome research.

Communicating the benefits and harms of colorectal cancer screening needed for an informed choice: a systematic evaluation of leaflets and booklets.

OBJECTIVE: Evidence-based health information (EBHI) can support informed choice regarding whether or not to attend colorectal cancer (CRC) screening. The present study aimed to assess if German leaflets and booklets appropriately inform consumers on the benefits and harms of CRC screening. METHODS: A systematic search for print media on CRC screening was performed via email enquiry and internet search. The identified documents were assessed for the presence and correctness of information on benefits and harms by two reviewers independently using a comprehensive list of criteria. RESULTS: Many of the 28 leaflets and 13 booklets identified presented unbalanced information on the benefits and harms of CRC screening: one-third did not provide any information on harms. Numeracy information was often lacking. Ten cross-language examples of common misinterpretations or basically false and misleading information were identified. DISCUSSION: Most of the CRC screening leaflets and booklets in Germany do not meet current EBHI standards. After the study, the publishers of the information materials were provided feedback, including a discussion of our findings. The results can be used to revise existing information materials or to develop new materials that provide correct, balanced, quantified, understandable and unbiased information on CRC screening.

Evidence-based health information from the users' perspective--a qualitative analysis.

BACKGROUND: Evidence-based information is a precondition for informed decision-making and participation in health. There are several recommendations and definitions available on the generation and assessment of so called evidence-based health information for patients and consumers (EBHI). They stress the importance of objectively informing people about benefits and harms and any uncertainties in health-related procedures. There are also studies on the comprehensibility, relevance and user-friendliness of these informational materials. But to date there has been little research on the perceptions and cognitive reactions of users or lay people towards EBHI. The aim of our study is to define the spectrum of consumers' reaction patterns to written EBHI in order to gain a deeper understanding of their comprehension and assumptions, as well as their informational needs and expectations. METHODS: This study is based on an external user evaluation of EBHI produced by the German Institute for Quality and Efficiency in Health Care (IQWiG), commissioned by the IQWiG. The EBHI were examined within guided group discussions, carried out with lay people. The test readers' first impressions and their appraisal of the informational content, presentation, structure, comprehensibility and effect were gathered. Then a qualitative text analysis of 25 discussion transcripts involving 94 test readers was performed. RESULTS: Based on the qualitative text analysis a framework for reaction patterns was developed, comprising eight main categories: (i) interest, (ii) satisfaction, (iii) reassurance and trust, (iv) activation, (v) disinterest, (vi) dissatisfaction and disappointment, (vii) anxiety and worry, (viii) doubt. CONCLUSIONS: Many lay people are unfamiliar with core characteristics of this special information type. Two particularly critical issues are the description of insufficient evidence and the attendant absence of clear-cut recommendations. Further research is needed to examine strategies to explain the specific character of EBHI so as to minimize unintended or adverse reaction patterns. The presented framework describes the spectrum of users' reaction patterns to EBHI. It may support existing best practice models for editing EBHI.

Development of a comprehensive list of criteria for evaluating consumer education materials on colorectal cancer screening.

BACKGROUND: Appropriate patient information materials may support the consumer's decision to attend or not to attend colorectal cancer (CRC) screening tests (fecal occult blood test and screening colonoscopy). The aim of this study was to develop a list of criteria to assess whether written health information materials on CRC screening provide balanced, unbiased, quantified, understandable, and evidence-based health information (EBHI) about CRC and CRC screening. METHODS: The list of criteria was developed based on recommendations and assessment tools for health information in the following steps: (1) Systematic literature search in 13 electronic databases (search period: 2000-2010) and completed by an Internet search (2) Extraction of identified criteria (3) Grouping of criteria into categories and domains (4) Compilation of a manual of adequate answers derived from systematic reviews and S3 guidelines (5) Review by external experts (6) Modification (7) Final discussion with external experts. RESULTS: Thirty-one publications on health information tools and recommendations were identified. The final list of criteria includes a total of 230 single criteria in three generic domains (formal issues, presentation and understandability, and neutrality and balance) and one CRC-specific domain. A multi-dimensional rating approach was used whenever appropriate (e.g., rating for the presence, correctness, presentation and level of evidence of information). Free text input was allowed to ensure the transparency of assessment. The answer manual proved to be essential to the rating process. Quantitative analyses can be made depending on the level and dimensions of criteria. CONCLUSIONS: This comprehensive list of criteria clearly has a wider range of evaluation than previous assessment tools. It is not intended as a final quality assessment tool, but as a first step toward thorough evaluation of specific information materials for their adherence to EBHI requirements. This criteria list may also be used to revise leaflets and to develop evidence-based health information on CRC screening. After adjustment for different procedure-specific criteria, the list of criteria can also be applied to other cancer screening procedures.

How do patients expect the mental health service system to act? Testing the WHO responsiveness concept for its appropriateness in mental health care.

The World Health Organisation (WHO) concept of responsiveness has been defined as a measure of how well the health system responds to the population's legitimate expectations of non-health aspects of health care provision. It comprises eight domains: dignity, prompt attention, autonomy, choice of health care provider, clear communication, confidentiality, quality of basic amenities, and access to social support networks. The concept is of particular relevance to mental health care systems because of the specific dependency and vulnerability of their users. We tested its applicability to mental health care with five focus groups of experienced mental health care users in Hannover, Germany. The focus groups revealed 492 statements about users' expectations in mental health care. Most concerned attention (115), dignity (108) and autonomy (86). The quotations were assigned to the eight responsiveness domains. In addition, the domain of prompt attention was extended and renamed attention, and the new domain continuity was created. The findings correspond with the literature on health care expectations of non-mental health patients, but differ slightly from the results of a WHO study on overall health care responsiveness. The need for widening the concept of continuity and extending the attention domain reflects the nature of mental health care of providing predominately long-term care. Our analysis indicates the feasibility of the responsiveness concept (if altered as proposed) as a tool for assessing the quality of mental health service from the users' point of view. It should also be further developed to quantitatively evaluate mental health care systems and to benchmark system performance.

The federal government commissioner for patient issues in Germany: initial analysis of the user inquiries.

BACKGROUND: The political objective in many countries worldwide is to give better consideration to the interests of patients within the health system. The establishment of a federal government commissioner for the issues of patients in the health system in Germany in 2004 is part of these endeavours. The structure and field of activities of this institution has been unique so far. This study investigates for the first time the inquiries the commissioner receives from the public. METHODS: A 33% sampling (n = 850) of the written inquiries (correspondence and e-mails) addressed to the commissioner in the first six months of the year 2005 (n = 2580) was investigated. In a procedure comprising combined qualitative and quantitative levels, the material was thematically encoded and the inquiries allocated to the resulting categories (multiple nominations). The results are presented in descriptive form and investigated especially with respect to sex and age-specific differences. The interdependences between the categorized criteria are analysed. RESULTS: The inquirers are equally spread out amongst the sexes (49% women, 51% men). Older persons outweigh the younger (69% over 60 years). In most cases the issues take the form of claims (72%, n = 609). In every fifth inquiry (n = 168) the personal financial burden for health services is considered as being too high; about equally high (n = 159) is the proportion of persons who criticize the communication with health professionals, especially hospitals and doctors' surgeries. Every third who mentions a medical practice uses terms such as "uncertainty" and "anxiety". It is conspicuous that men more often than women write that they feel unfairly treated in the health system (62% vs. 38%, p < 0.05). CONCLUSION: Predominantly older persons seek the assistance of the federal government commissioner for patient issues. Considerable uncertainty and anxiety with respect to services and charges within the system of the German health insurances become evident. It is not possible from the data to draw conclusions concerning the impact of the commissioner's work on the health system. Nor do we gain any knowledge about the usefulness of the service for the individual. Therefore, evaluation of the political impact and the user satisfaction should follow.

[Patient and consumer information centres according to 65b Social Security Code V--means for high-quality information exchange and counselling]. / Patienten- und Verbraucherberatungsstellen nach 65b SGB V--Wege zu einer qualitativ hochwertigen Informationsvermittlung und Beratung.

Counsellors of Independent Health Information Centres according to 65b Social Security Code V provide the public with comprehensive information on health and disease-related themes, as well as on their financial, service, and legal aspects; they also provide extensive counselling and psychosocial support. The counsellors mostly have a university background in educational, social, medical, or legal disciplines; they usually have long-term experience in counselling as well as additional professional qualifications. In addition to the provision of information, independent health information centres must also be active in assuring and promoting their own quality control. Different measures are applied for this purpose, however at this time there are no standardised, high-quality activities of the independent health information centres to ensure quality.