Exploring the information needs of patients with osteoarthritis of the knee: a content analysis of Facebook group posts.

BACKGROUND: End-stage osteoarthritis of the knee (OAK) is often treated by total knee arthroplasty (TKA). This intervention can significantly improve quality of life. However, many patients are dissatisfied with the outcome of surgery. One of the factors related to dissatisfaction is the of lack integration of patients' preferences, habits and values that are not addressed by physicians. To develop realistic expectations, affected patients need evidence-based information. Our aim was to explore the information needs of patients with OAK to support the development of decision aids and consent forms to promote informed decision-making. Additionally, we investigated whether the information needs during the Covid-19 pandemic differ from those before the pandemic. METHODS: The qualitative research design included a social media analysis of Facebook groups. Facebook groups were selected according to the following criteria: Thematic relevance, English or German language, at least one new post per week, from period before and after the start of the Covid-19 pandemic in March 2020. Thematically relevant group posts were analysed according to the content-structuring content analysis of Kuckartz using MaxQDA. RESULTS: Out of 448 identified Facebook groups, we screened seven for relevant posts and a total of 77 posts out of 6 groups were selected. The following eight categories were derived during the coding process: access to health care, disease information, TKA indication and contraindication, TKA outcome and quality of life, information needs regarding conservative therapy, strain, attitude towards TKA and attitude towards conservative therapy. The analysis showed that patients with OAK need information about the benefits and risks of TKA and conservative therapies. CONCLUSION: This study provides information on the information needs of patients with OAK in order to decide between TKA or conservative therapy. Patients need information about treatment options in due consideration of their immediate living situation to be reliably able to assess potential outcomes. Such Information about TKA should enable patients to assess the individual prognosis with comprehensible and relevant outcome measures. Also, they should be formulated with the living environment of the patients in mind and be linked to possible fears and negative previous experiences with treatments.

Evaluating student's ability to assess treatment claims: validating a German version of the Claim Evaluation Tools.

BACKGROUND: The Claim Evaluation Tools measure the ability to assess claims about treatment effects. The aim of this study was to adapt the German item sets to the target group of secondary school students (aged 11 to 16 years, grade 6 to 10) and to validate them accordingly. The scale's reliability and validity using Rasch's probabilistic test theory should be determined. METHODS: We conducted a sequential mixed-method study comprising three stages: contextualisation and adaption of the items (stage 1), piloting of the item sets using qualitative interviews (stage 2) and a construct validation by testing the unidimensional Rasch scalability for each item set after data collection in one secondary school in Germany and two secondary schools in Austria. We explored summary and individual fit statistics and performed a distractor analysis (stage 3). RESULTS: Secondary school students (n = 6) and their teachers (n = 5) participated in qualitative interviews in Germany. The qualitative interviews identified the need for minor modifications (e.g. reducing thematic repetitions, changing the order of the items). The data of 598 German and Austrian secondary school students were included to test for Rasch scalability. Rasch analyses showed acceptable overall model fit. Distractor analyses suggested that model fit could be improved by simplifying the text in the scenarios, removing and editing response options of some items. CONCLUSION: After the revision of some items, the questionnaires are suitable to evaluate secondary school students' ability to assess health claims. A future goal is to increase the pool of items being translated and tested.

Public information needs and preferences on COVID-19: a cross-sectional study.

BACKGROUND: Right from the beginning of the SARS-CoV-2 pandemic the general public faced the challenge to find reliable and understandable information in the overwhelming flood of information. To enhance informed decision-making, evidence-based information should be provided. Aim was to explore the general public's information needs and preferences on COVID-19 as well as the barriers to accessing evidence-based information. METHODS: We performed a cross-sectional study. Nine hundred twenty-seven panel members were invited to an online survey (12/2020-02/2021). The HeReCa-online-panel is installed at the Martin Luther University Halle-Wittenberg to assess regularly the general public's view on health issues in five regions in Germany. The survey was set up in LimeSurvey, with nine items, multiple-choice and open-ended questions that allowed to gather qualitative data. Quantitative data were analysed descriptively and a content analysis was carried out to categorise the qualitative data. RESULTS: Six hundred thirty-six panel members provided data; mean age 52 years, 56.2% female, and 64.9% with higher education qualifications. Asked about relevant topics related to COVID-19, most participants selected vaccination (63.8%), infection control (52%), and long-term effects (47.8%). The following 11 categories were derived from the qualitative analysis representing the topics of interest: vaccination, infection control, long-term effects, therapies, test methods, mental health, symptoms, structures for pandemic control, infrastructure in health care, research. Participants preferred traditional media (TV 70.6%; radio 58.5%; newspaper 32.7%) to social media, but also used the internet as sources of information, becoming aware of new information on websites (28.5%) or via email/newsletter (20.1%). The knowledge question (Which European country is most affected by the SARS-CoV-2 pandemic?) was correctly answered by 7.5% of participants. The Robert Koch Institute (93.7%) and the World Health Organization (78%) were well known, while other organisations providing health information were rarely known (< 10%). Barriers to accessing trustworthy information were lack of time (30.7%), little experience (23.1%), uncertainty about how to get access (22.2%), complexity and difficulties in understanding (23.9%), and a lack of target group orientation (15,3%). CONCLUSIONS: There are extensive information needs regarding various aspects on COVID-19 among the general population. In addition, target-specific dissemination strategies are still needed to reach different groups.

Informed consent for total knee arthroplasty: exploration of patient`s information acquisition and decision-making processes-a qualitative study.

BACKGROUND: Total knee arthroplasty (TKA) is an option for the treatment of knee osteoarthritis (OA). Patients have high expectations regarding the benefits of the actual operation. Patients can seek a second opinion on the indication for TKA. In a study, less than half of recommended TKAs were confirmed by the second opinion and conservative treatments are not fully utilized. Informed consent forms that are used in Germany usually do not meet the requirements to support informed decision-making. Our aim was to describe the process from the diagnosis of knee OA through the decision-making process to the informed consent process for TKA, and to understand when, how, and by whom decisions are made. Moreover, we wanted to describe patients' information needs and preferences about knee OA and its treatment, including TKA, and find out what information is provided. We also wanted to find out what information was important for decision-making and identify barriers and facilitators for the optimal use of evidence-based informed consent forms in practice. METHODS: We chose a qualitative approach and conducted semi-structured interviews with patients who were going to receive, have received, or have declined TKA, and with general practitioners (GP), office-based as well as orthopaedists and anaesthesiologists in clinics who obtain informed consent. The interviews were audio-recorded, transcribed and analysed using qualitative content analysis. RESULTS: We conducted interviews with 13 patients, three GPs, four office-based orthopaedists and seven doctors in clinics who had obtained informed consent. Information needs were modelled on subjective disease theory and information conveyed by the doctors. Patients in this sample predominantly made their decisions without having received sufficient information. Trust in doctors and experiences seemed to be more relevant in this sample than fact-based information. Office-based (GPs, orthopaedists) and orthopaedists in clinics had different understandings of their roles and expectations in terms of providing information. CONCLUSIONS: We were able to identify structural barriers and assumptions that hinder the implementation of evidence-based informed consent forms.

[Pre-existing Mental Disorders and Depressiveness in the Second Wave of the SARS-CoV-2-Pandemic - The Role of Pandemic-Associated Stressors]. / Psychische Vorerkrankungen und Depressivität in der 2. Welle der SARS-CoV-2-Pandemie in Deutschland ­ Die Rolle pandemieassoziierter Stressoren.

The second wave of the SARS-CoV-2 pandemic was characterized by drastic restrictions. From previous pandemics as well as from the first wave, it is known that especially individuals with a history of mental disorders may be highly vulnerable to develop poor mental health. Therefore, this paper examines the association of prior mental disorders (PMD) and depressiveness in the 2nd pandemic wave, considering general stress, perceived isolation, perception of political measures to curb the pandemic, fears regarding consequences of the pandemic and changes in the employment and income situation. A cross-sectional analysis was conducted with data of 812 participants of the health related beliefs and health care experiences in Germany study (HeReCa). The association between PMD and depressiveness was studied by means of weighted (for education and age) logistic regression, adjusted for the named variables as well as sociodemographic characteristics. Individuals with PMD displayed substantially more often higher depressiveness than individuals without PMD (OR: 25.1; 95% CI: 11.0-57.3). This association decreased partially by accounting for higher general stress and stress from isolation. Lack of partnership, low income, and male sex were associated with higher depressiveness, but only marginally changed the association of PMD and depressiveness. Overall, during the pandemic, persons with PMD were more likely to develop higher depressiveness than persons without. It is strongly advised to provide care for mental illness in pandemic times, which can be completed by E-Mental-Health or professional support for coping with stress.

[Comprehension and Perspectives of the Need for Medical Rehabilitation - Results of a German Online Survey]. / Verständnis und Bedürfnis medizinischer Rehabilitation in der Bevölkerung ­ Ergebnisse einer Online-Befragung.

BACKGROUND: In Germany, medical rehabilitation usually requires an application of the persons in need. Therefore, these persons have to understand what rehabilitation is and in what case they need this type of health care service. In addition to people with health problems, their close persons (e. g. family members) should also have rehabilitation-related knowledge. Since there is only limited data on the perspective towards medical rehabilitation services, a survey was conducted. METHOD: In September 2020, we invited 2,401 registered participants (age: 18-79 years) of a population-based online panel study to participate in an online survey. The cross-sectional survey asked about the understanding of need, subjective information as well as attitudes and expectations towards medical rehabilitation services. We analysed the data descriptively, taking into account the participants' rehabilitation experience and health impairment. In a subgroup analysis, the potential factors influencing the subjective need for rehabilitation were tested using logistic regression. RESULTS: Data from 1,464 persons (Ø age: 52.5±14.5 years; 55% non-male) were analysed, 44% of the participants considered themselves to be "rather well" or "very well" informed about medical rehabilitation. The majority associated a need for rehabilitation with the access requirements related to service providers. In case of an emerging need for rehabilitation, family doctors would be the first point of contact. The participants mainly had function-oriented expectations of rehabilitation services and a majority prefer inpatient rehabilitation if necessary. Among 383 persons with long lasting and pronounced health-related impairment, the concrete individual need for rehabilitation was associated by a higher subjective degree of impairment as well as their own previous rehabilitation experience and rehabilitation experience in their personal social environment. CONCLUSION: Despite an overall good understanding of the need for rehabilitation, different rehabilitation views were found in certain population groups. In order to improve the general understanding of rehabilitation in the public and particularly in close persons, adequate dissemination of low-threshold, population-based rehabilitation information is recommended.

[Reasons and Influencing Factors for the Willingness to Document Preferences Regarding Organ Donation: Results of an Online Survey]. / Gründe und Einflussfaktoren für die Bereitschaft zur Dokumentation von Präferenzen bezüglich Organspende. Ergebnisse einer Online-Umfrage.

OBJECTIVE: Different options to regulate decisions about organ transplantation were subjected to discussions prior to parliamentary decision on 16.01.2020. The goal of this study was the description of citizens' attitudes towards organ donation and investigation of predictors of (documentation of) willingness to donate. METHODS: Cross sectional online survey in Berlin and Saxony-Anhalt between 25.11.2019 till 16.01.2020. Descriptive, statistical analysis. We report absolute and relative frequencies. We conducted logistic regression analysis for the influence of age, income and gender on knowledge, willingness to donate and possession of an organ donor card. RESULTS: Of 20 020 invited citizens, 676 (3.4%) participated in the online survey; 54.9% were in favour of an opt-out regulation, 49.4% supported an opt-in regulation, 63.3% of respondents were willing or rather willing to donate an organ and 43.2% possessed an organ donor card. Willingness to donate and possession of an organ donor card decreased with increasing age. A Higher educational level was associated with having an organ donor card. Gender, income, education and knowledge about organ donation were not associated with the willingness to donate an organ. Of those who were willing to donate but who had not a donor card, 45.7% had communicated their will to relatives. Reasons indicated for lack of documentation included practical reasons as also fears related to medical care in case of critical health state. DISCUSSION: None of the discussed legislative regulations on organ donation has been supported by a clear majority of respondents. Distinct population-based surveys can serve as starting point for developing targeted initiatives to increase the documentation of citizens' will regarding organ donation following brain death.

Nurse-led decision coaching by specialized nurses for healthy BRCA1/2 gene mutation carriers - adaptation and pilot testing of a curriculum for nurses: a qualitative study.

BACKGROUND: Women with BRCA1/2 mutations are at high risk to develop breast and ovarian cancer. To support these women to participate in shared decision-making, structured nurse-led decision coaching combined with an evidence-based decision aid may be employed. In preparation of the interprofessional randomized controlled trial to evaluate a decision coaching program to support preventive decisions of healthy female BRCA 1/2 gene mutation carriers (EDCP-BRCA), we adapted and piloted an existing training program for specialized nurses and included elements from an existing physician communication training. METHODS: The training was adapted according to the six-step-approach for medical curriculum development. The educational design is based on experience- and problem-based learning. Subsequently, we conducted a qualitative pilot study. Nurses were recruited from six German centers for familial breast and ovarian cancer. The acceptability and feasibility were assessed by structured class observations, field notes and participants' feedback. Data were analyzed using qualitative content analysis. The training was revised according to the results. Due to the COVID-19 pandemic, the patient intervention was adapted as a virtual coaching and a brief additional training for nurses was added. RESULTS: The training consists of two modules (2 + 1 day) that teach competences in evidence-based medicine and patient information, (risk) communication and decision coaching. One pilot test was conducted with six nurses of which three were specialized and experienced in patient counselling. A final set of eight main categories was derived from the data: framework conditions; interaction; schedule, transparency of goals, content, methods, materials and practical relevance and feasibility. Overall, the training was feasible and comprehensible. Decision coaching materials were awkward to handle and decision coaching role plays were set too short. Therefore, materials will be sent out in advance and the training was extended. CONCLUSIONS: Specialized nurses are rarely available and nurse-led counselling is not routinely implemented in the centers of familial breast and ovarian cancer. However, training of less qualified nurses seems feasible. Decision coaching in a virtual format seems to be a promising approach. Further research is needed to evaluate its feasibility, acceptability and effectiveness. TRIAL REGISTRATION: The main trial is registered under DRKS-ID: DRKS00015527 .

A survey on critical health competences among diabetes educators using the Critical Health Competence Test (CHC Test).

BACKGROUND: Diabetes associations claim to have a patient-centered approach in diabetes care including shared decision-making (SDM). Diabetes educators are important healthcare professionals for implementing the concept of informed SDM in diabetes care. They need critical health competences (CHC) in order to provide evidence-based information and to support patients in understanding the risks of the disease and also the possible benefits or harm of the healthcare options. Therefore, we surveyed the CHC of diabetes educators. METHODS: We performed a cross-sectional survey using the validated Critical Health Competences (CHC) Test to measure CHC of certified diabetes educators and trainees in Germany. Diabetes educators were approached via newsletter, mailing lists or in person during the conference of the German Diabetes Association. Trainees were approached during their training sessions. We applied scenario 1 of the CHC test, which comprises 17 items with open-ended and multiple-choice questions. Mean person parameters with a range from 0 to 1000 were calculated to assess the levels of critical health competences and a multiple linear regression analysis was conducted to determine correlations between sociodemographic variables and levels of CHC. RESULTS: A total of 325 participants, mean age 38.6 (±11.1) years, completed the CHC test; n = 174 (55.5%) were certified diabetes educators and n = 151 (46.5%) were trainees. The participants achieved a mean score of 409.84 person parameters (±88.10) (scale from 0 to 1000). A statistically significant association was found only between the level of education and the level of CHC (b = 0.221; p-value 0.002). Participants with grammar school education achieved higher mean scores compared to participants with secondary school education (432.88 ± 77.72 vs. 396.45 ± 85.95; mean difference 36.42 ± 9.29; 95%CI 18.15 to 54.71; p < 0.0001). CONCLUSION: Diabetes educators achieved low competence scores and it can be assumed that they do not have sufficient CHC to conduct consultations based on the SDM principles. Poor CHC among healthcare providers are a major barrier for the implementation of SDM. Core concepts of evidence-based medicine should be implemented into the curricula for diabetes educators in order to increase their levels of CHC.

A blended learning training programme for health information providers to enhance implementation of the Guideline Evidence-based Health Information: development and qualitative pilot study.

BACKGROUND: The Guideline Evidence-based Health Information was published in 2017 and addresses health information providers. The long-term goal of the guideline is to improve the quality of health information. Evidence-based health information represents a prerequisite for informed decision-making. Health information providers lack competences in evidence-based medicine. Therefore, our aim was to develop and pilot-test a blended learning training programme for health information providers to enhance application of the guideline. METHODS: 1. DEVELOPMENT: We developed the training programme according to the Medical Research Council guidance for developing and evaluating complex interventions. The training programme was planned on the basis of problem-based learning. It aims to impart competences in evidence-based medicine. Furthermore, it comprises the application of criteria for evidence-based health information. 2.Pilot testing: We conducted a qualitative pilot study focusing on the acceptability and feasibility of the training programme. Health information providers were recruited and in-house training sessions were offered. Feasibility and acceptability were explored by structured class observations and in semi-structured focus group interviews with the participants after the training sessions. The transcripts and documentations were analysed using qualitative content analysis according to Mayring. The training was revised iteratively according to the results. RESULTS: We conducted two training courses with 17 participants between November 2018 and March 2019. The adequacy of the training for the target group was identified as a major issue. There was significant heterogeneity concerning previous knowledge. Some wished to delve deeper while others seemed to be overwhelmed. In general, the work tasks were understandable. However, the participants asked for a more detailed theoretical introduction in advance. The practical relevance of the evidence-based medicine contents was rated rather low compared to the content about evidence-based health information. Based on these results, we revised the programme. CONCLUSIONS: Overall, the training proved to be feasible for implementation. Meeting the needs of all the participants was a challenge, since they were heterogeneous. Not all of them will be able or intend to implement the training contents into their working routine to the full extent. The implementation will be evaluated in a randomised controlled trial.

Communicating prognosis to women with early breast cancer - overview of prediction tools and the development and pilot testing of a decision aid.

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 developed and pilot-tested a decision aid (DA) addressing individual prognosis using additional chemotherapy in early, hormone receptor-positive breast cancer as an example. METHODS: Systematic literature search on clinical prediction tools for the effects of drug treatment on survival of breast cancer. The DA was developed following criteria for evidence-based patient information and International Patient Decision Aids Standards. We included data on the influence of age and comorbidities on overall prognosis. The DA was pilot-tested in focus groups. Comprehension was additionally evaluated through an online survey with women in breast cancer self-help groups. RESULTS: We identified three prediction tools: Adjuvant!Online, PREDICT and CancerMath. All tools consider age and tumor characteristics. Adjuvant!Online considers comorbidities, CancerMath displays age-dependent non-cancer mortality. Harm due to therapy is not reported. Twenty women participated in focus groups piloting the DA until data saturation was achieved. A total of 102 women consented to participate in the online survey, of which 86 completed the survey. The rate of correct responses was 90.5% and ranged between 84 and 95% for individual questions. CONCLUSIONS: None of the clinical prediction tools fulfilled the requirements to provide women with all the necessary information for informed decision-making. Information on individual prognosis was well understood and can be included in patient decision aids.

Implementation of shared decision-making in oncology: development and pilot study of a nurse-led decision-coaching programme for women with ductal carcinoma in situ.

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 nurses (breast care nurses and oncology nurses) and structured physician encounters. In order to enable professionals to gain ISDM competencies, we developed and tested a curriculum-based training programme for specialised nurses and a workshop for physicians. After successful testing of the components, we conducted a pilot study to test the feasibility of the entire revised intervention in two breast care centres. Here the acceptance of the intervention by women and professionals, the applicability to the breast care centres' procedures, women's knowledge, patient involvement in treatment decision-making assessed with the MAPPIN'SDM-observer instrument MAPPIN'Odyad, and barriers to and facilitators of the implementation were taken into consideration. We used questionnaires, structured verbal and written feedback and video recordings. Qualitative data were analysed descriptively, and mean values and ranges of quantitative data were calculated. RESULTS: To test the DA, focus groups and individual interviews were conducted with 27 women. Six expert reviews were obtained. The components of the nurse training were tested with 18 specialised nurses and 19 health science students. The development and piloting of the components were successful. The pilot test of the entire intervention included seven patients. In general, the intervention is applicable. Patients attained adequate knowledge (range of correct answers: 9-11 of 11). On average, a basic level of patient involvement in treatment decision-making was observed for nurses and patient-nurse dyads (M(MAPPIN-Odyad): 2.15 and M(MAPPIN-Onurse): 1.90). Relevant barriers were identified; physicians barely tolerated women's preferences that were not in line with the medical recommendation. Classifying women as inappropriate for ISDM due to age or education led physicians to neglect eligible women during the recruitment phase. CONCLUSION: Decision-coaching is feasible. Nevertheless, there are some indications that structural changes are needed for long-term implementation. We are currently evaluating the intervention in a cluster randomised controlled trial in 16 breast care centres.

[Advancing standards for the development of evidence-based health information for consumers: Needs and priorities among members of the Network for Evidence-based Medicine]. / Inhaltliche Weiterentwicklung von Standards zur Erstellung evidenzbasierter Gesundheitsinformationen: Eine Bedarfserhebung und Priorisierung im EbM-Netzwerk.

BACKGROUND: The Good Practice Guidelines for health information, Good Health Information Austria and Guideline Evidence-based Health Information are established resources for developing evidence-based health information in the German-speaking regions. The aim of this project was to capture challenges in applying these standards in practice, identify gaps and development needs and gain insights for their further development. METHODS: In December 2020, members of the working group for patient information and involvement of the Network for Evidence-based Medicine were invited to share their experiences and needs in applying German standards for evidence-based health information through an online survey focussing on open questions (part 1: needs assessment). The feedback was analysed using qualitative content analysis and presented in a workshop at the EbM Congress 2021 with the goal of specifying the feedback from the needs assessment and discussing ideas for the further development of the standards (part 2: specification). In the final step, a second survey was conducted in February 2023 to prioritize the identified topics by the working group members (part 3: prioritization). The results were analysed descriptively. RESULTS: Among the 41 participants, only 23% considered the standards to be sufficient, and only 55% found their application in the development of information to be easy or rather easy. The needs assessment and workshop (n=46) helped to identify various areas of action. With regard to the application of the standards, the following challenges were identified: lack of user orientation, content gaps, methods and risk communication. Gaps in the standards were identified regarding formats, content, and the connection to healthcare provision. For the advancement of the standards ideas for additional content, stakeholder involvement, and improvement of the usability of the standards were identified. In the prioritization survey, the topic areas, "presenting benefits and harms" and "content beyond treatments (in particular, diagnostics and prognosis)" were considered to be the most important (n=36). DISCUSSION: Among members of the working group for patient information and involvement of the German Network for Evidence-based Medicine, a high demand has been identified for the further development of standards for creating evidence-based health information. In addition to content development, the integration of existing documents and tools should also be considered, including products issued by other institutions. The success of advancing the standards also depends on improving their applicability - for example through an attractive online platform. The results are limited by the sample which only included members of the EbM Network's patient information and participation working group and a limited response rate. CONCLUSIONS: The needs assessment showed that the currently established standards and recommendations for the development of evidence-based health information in the German-speaking regions represent important cornerstones but need to be expanded to answer more practice-oriented questions. The challenges and proposed solutions stated by the participants can help further develop the standards. The prioritization can be used to set priorities for the development of the standards, guide the order of possible work packages and allocate resources.

To Remind or Not to Remind During Recruitment? An Analysis of an Online Panel in Germany.

Objective: To explore the role of reminders in recruiting and maintaining participation in an online panel. Methods: 50,045 individuals from five German federal states were invited by regular mail to participate in the online study "Health-Related Beliefs and Healthcare Experiences in Germany." Those who did not respond to the first attempt received a postal reminder. Comparisons of sociodemographic characteristics and responses were made between first-attempt respondents and those who enrolled after the second letter. Results: After the initial letter, 2,216 (4.4%, 95%CI: 4.3%-4.6%) registered for the study; after a reminder 1,130 (2.5%, 2.3%-2.6% of those reminded) enrolled. Minor sociodemographic differences were observed between the groups and the content of the responses did not differ. Second-attempt respondents were less likely to participate in subsequent questionnaires: 67.3% of first-attempt vs. 43.3% of second-attempt respondents participated in their fourth survey. Recruitment costs were 79% higher for second-attempt respondents. Conclusion: While reminders increased the number of participants, lower cost-effectiveness and higher attrition of second-attempt respondents support the use of single invitation only for studies with a similar design to ours when the overall participation is low.

Decision Coaching for Healthy Women With BRCA1/2 Pathogenic Variants­Findings of the Randomized Controlled EDCP-BRCA Trial.

BACKGROUND: Women with BRCA1/2 pathogenic variants (PVs) have a choice of preventive options. To help these women decide for themselves, we developed and implemented a decision coaching (DC) program and evaluated it for congruence between the participants' desired and actual roles in decision-making. METHODS: Healthy BRCA1/2 PV carriers (from 25 to 60 years of age) were recruited at six centers in Germany. Those returning baseline T1-questionnaires were randomly assigned to the intervention group (IG) or the control group (CG). The IG attended a nurse-led DC program. The primary outcome was congruence between the participants' desired and actual roles in decision-making. The secondary outcomes included an active role, satisfaction, decisional conflict, and knowledge. Follow-up data were obtained by questionnaire at 12 weeks (T2) and 6 months (T3). RESULTS: Of the 413 women who were recruited, 389 returned baseline T1 questionnaires. At T2, the IG and CG groups did not differ significantly in congruence between their desired and actual roles in decision-making (0.12 [95% confidence interval -0.03; 0.28], p=0.128), with a slightly higher congruence in the CG. Women in both groups were more active at T2 than their stated preference at T1, with a notably higher percentage in the IG (IG: 40%, CG: 24.4%; [-25.1; -6.1]). IG participants were more satisfied with the role that they had assumed and had less decisional conflict and greater knowledge. CONCLUSION: These findings imply that this DC program can help women with BRCA1/2 PVs participate actively in decision-making with regard to preventive measures.

Enhancing Transsectoral Interdisciplinary Patient-Centered Care for Patients With Rare Cancers: Protocol for a Mixed Methods Process Evaluation.

BACKGROUND: Rare cancers account for approximately 24% of all new cancers. The category of rare tumor diseases includes almost 200 different entities. In particular, the treatment of patients with extensive care needs requires cooperation between service providers, both between sectors (outpatient and inpatient) and within sectors (eg, between different medical disciplines). The treatment pathway is associated with a high need for coordination and information sharing between providers. When crossing sectoral boundaries in the German health care system, interface problems between the outpatient and inpatient sectors can lead to gaps in care delivery. The multicomponent program Trans-sectoral Personalised Care Concept for Patients with Rare Cancers aims to optimize transsectoral cooperation and coordination of care to enhance patient involvement and the medical care coordination of patients with rare cancers. OBJECTIVE: This process evaluation will contribute to answering questions about intervention fidelity and the implementation of transsectoral communication, identifying and describing the intended and nonintended effects of the intervention, and exploring the barriers to and facilitators of the implementation. METHODS: We will include patients who participate in the intervention phase; all persons and staff involved in the development and implementation of the intervention (Onco Coach, psychologists, physicians on the contact platform, IT staff, and staff of the Bavarian Association of Statutory Health Insurance Physicians); physicians from the Ludwig-Maximilians-University Hospital Munich and the hospital of the Technical University Munich who are involved in the treatment of patients during the course of the project; and participating office-based hematologists and oncologists. Data collection will be conducted at the beginning, during, and at the end of the intervention using mixed methods. Data will be collected from questionnaires, document analyses, semistructured interviews, and structured observations and will cover different aspects of process evaluation. These include examining the context to explore existing patterns, changes in patterns, attitudes, and interactions; analyzing the implementation of intervention elements; and exploring the complex causal pathways and mediators of the intervention. Qualitative data will be analyzed using thematic analysis. The data will then be combined using between-methods triangulation. RESULTS: This project received funding on March 1, 2022. The intervention phase and recruitment for the process evaluation began on March 1, 2023, and the recruitment is expected to end on September 30, 2025. At the time of protocol submission in June 2023, a total of 8 doctors from hematology and oncology practices were enrolled. Data collection began on March 14, 2023. CONCLUSIONS: The Trans-sectoral Personalised Care Concept for Patients with Rare Cancers project is a complex intervention that is to be implemented in an equally complex health care context. The process evaluation will help understand the influence of contextual factors and assess the mechanisms of change. TRIAL REGISTRATION: ISRCTN registry ISRCTN16441179; https://doi.org/10.1186/ISRCTN16441179. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/49731.

The effects of modifying elements of written informed consent forms for elective surgical or invasive procedures: A systematic review.

OBJECTIVE: To study the effect of modifying content and design elements within written informed-consent-forms (ICF) for patients undergoing elective surgical or invasive procedures. METHODS: We included (quasi-)randomized trials in which a modified written ICF (e.g. visual aids) was compared to a standard written ICF. We searched PubMed, Web-of-Science and PsycINFO until 08/2021. Risk of Bias was assessed. The complexity of intervention was assessed using the Intervention Complexity Assessment Tool for Systematic Reviews. RESULTS: Eleven trials with 1091 participants were eligible. Effect sizes and levels of evidence varied from trivial to moderate andthere were contradictory findings for some outcomes. Providing patients with more informationin general or specific information on risks and complications mostly increased anxiety. The use of verbal risk presentation decreased anxiety and increased satisfaction.A lower readability level decreased anxiety and improved comprehension and knowledge. CONCLUSION: Our results suggest that providing more information and addressing certain types of risks have differential effects. While more information improved knowledge, it also increased anxiety. We did not find any or only insufficient evidence for many other possible ICF modifications. PRACTICE IMPLICATIONS: When developing ICFs the differential impact of different elements on patient important outcomes should be carefully considered.

Knowledge and worries on motherhood choice in multiple sclerosis - a cross-sectional study on patient-reported outcome measures.

BACKGROUND: Since multiple sclerosis (MS) is often diagnosed in young women, pregnancy is a common topic for women with MS (wwMS). The study aimed to assess the measurement properties of two patient-reported outcome measures on motherhood choice in MS, and to explore the information and support needs of wwMS concerning motherhood. METHODS: We conducted an anonymous web-based survey to validate the motherhood/pregnancy choice and worries questionnaire (MPWQ, 31 items plus up to 3 additional items) and the motherhood choice knowledge questionnaire (MCKQ, 16 items). We used mailing lists and social media for nationwide recruitment in Germany, and included women of childbearing age with relapsing-remitting MS, clinically isolated syndrome or suspected MS who were considering pregnancy or were pregnant. For the MPWQ, we assessed item difficulty, discriminatory power, and internal consistency (Cronbach's alpha; CA). We analysed construct validity using the Leipzig Questionnaire of Motives to have a Child, the Decisional Conflict Scale, the Hospital Anxiety and Depression Scale, and the Pregnancy-Related Anxiety Questionnaire-revised 2. We studied the structural validity using exploratory factor analysis (EFA). The MCKQ was evaluated descriptively. We explored the information and support needs of wwMS on motherhood descriptively. We examined correlations between MCKQ, MPWQ and clinical characteristics and performed exploratory group comparisons considering the following binary variables: having children and being pregnant. RESULTS: 325 wwMS started the survey; 232 wwMS met our inclusion criteria and were analysed. Their mean age was 30 years (SD 5). Most women had relapsing-remitting MS (n = 218; 94%), 186 (80%) had no children, and 38 (16%) were pregnant. Internal consistency was good for the worries subscale (CA>0.8), while it was unsatisfactory for the attitude and coping subscales (CA<0.7). The EFA did not support the three-scale structure (coping, attitude, and worries). Due to these findings, we decided to keep the worries scale without any subscale. The items from the coping scale and attitude scale could be assessed as additional descriptive items. Convergent and divergent construct validity of the MPWQ was satisfactory. 206 wwMS (89%) completed the MCKQ. On average, 9 of 16 (56%) items were answered correctly (range 2-15), and the questionnaire showed a good balance between easy and difficult items. Questions on immunotherapy, disease activity, and breastfeeding were the most challenging. WwMS were confident in getting pregnant and raising a child (n = 222; 96%). Most wwMS were worried about postpartum relapses (n = 200; 86%) and the long-term effects of pregnancy on disease evolution (n = 149; 64%). About half of the wwMS (n = 124; 54%) did not know where to find professional help and 127 (55%) had no strategies to cope with future impairments so that they could take care of a child. CONCLUSION: Our results support the suitability and acceptability of both questionnaires as potential patient-reported measures for assessment of knowledge and worries around motherhood/pregnancy in MS. The survey results highlight the need for evidence-based information on motherhood in MS to increase knowledge, reduce worries and support wwMS in making informed decisions.

MAPPinfo - mapping quality of health information: Validation study of an assessment instrument.

BACKGROUND: Health information is a prerequisite for informed choices-decisions, made by individuals about their own health based on knowledge and in congruence with own preferences. Criteria for development, content and design have been defined in a corresponding guideline. However, no instruments exist that provide reasonably operationalised measurement items. Therefore, we drafted the checklist, MAPPinfo, addressing the existing criteria with 19 items. OBJECTIVES: The current study aimed to validate MAPPinfo. METHODS: Five substudies were conducted subsequently at the Martin Luther University Halle-Wittenberg, Germany and the Medical University of Graz, Austria: (1) to determine content validity through expert reviews of the first draft, (2) to determine feasibility using 'think aloud' in piloting with untrained users, (3) to determine inter-rater reliability and criterion validity through a pretest on 50 health information materials, (4) to determine construct validity using 50 developers' self-declarations about development methods as a reference standard, (5) to determine divergent validity in comparison with the Ensuring Quality Information for Patients (EQIP) (expanded) Scale. The analyses used were qualitative methods and correlation-based methods for determining both inter-rater reliability and validity. RESULTS: The instrument was considered by experts to operationalise the existing guidelines convincingly. Health and nursing science students found it easy to understand and use. It also had good interrater reliability (mean of T coefficients = .79) and provided a very good estimate of the reference standard (Spearman's rho = .89), implying sound construct validity. Finally, comparison with the EQIP instrument revealed important and distinct areas of similarities and differences. CONCLUSIONS: The new instrument is ready for use as a screening instrument without the need for training. According to its underpinning concept the instrument exclusively comprises items which are justified by either ethics or research evidence, implying negligence of not yet evidence based, however, potentially important criteria. Further research is needed to complete the body of evidence-based criteria, aiming at an extension of the guideline and MAPPinfo. TRIAL REGISTRATION NUMBER: AsPredicted22546; date of registration: 24 July 2019.

Efficacy of Three Numerical Presentation Formats on Lay People's Comprehension and Risk Perception of Fact Boxes-A Randomized Controlled Pilot Study.

(1) Background: Fact boxes present the benefits and harms of medical interventions in the form of tables. Some studies suggest that people with a lower level of education could profit more from graphic presentations. The objective of the study was to compare three different formats in fact boxes with regard to verbatim and gist knowledge in general and according to the educational background. (2) Methods: In May 2020, recruitment started for this randomized controlled trial. Participants were given one out of three presentation formats: natural frequencies, percentages, and graphic. We used Limesurvey® to assess comprehension/risk perception as the primary outcome. The Kruskal-Wallis test and the Mann-Whitney U test were used in addition to descriptive analyses. (3) Results: A total of 227 people took part in the study. Results of the groups were nearly identical in relation to the primary outcome verbatim knowledge, likewise in gist knowledge. However, participants with lower educational qualifications differed from participants with higher educational qualifications in terms of verbatim knowledge in the group percentages. (4) Conclusions: The results indicate that all three forms of presentation are suitable for conveying the content. Further research should take the individual preferences regarding the format into account.