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.
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.
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.
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.
Abstract
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.
Legal representatives take a major role in healthcare decisions with and for people with dementia, but only a minority has a qualification in this field. The aim was to evaluate the efficacy of the ...PRODECIDE education program for legal representatives. In a prospective randomized controlled trial, legal representatives (volunteers and professionals, representing at least one person with dementia) were allocated (1:1 computer-generated block randomization) to the intervention (PRODECIDE education program) and control (standard care) groups. The primary outcome measure was knowledge, operationalized as the understanding of decision-making processes and in setting realistic expectations. Only data entry and analyses were blinded. A process evaluation in a mixed methods design was performed. We enrolled 218 legal representatives, and 216 were included in the primary analysis (intervention
= 109, control
= 107). The percentage of correct answers in the knowledge test post intervention was 69.0% in the intervention and 43.4% in the control group (difference 25.6%; CI 95%, 21.3 to 29.8;
< 0.001). In the comparison of professional and voluntary representatives, professionals had 13.6% (CI 95%, 8.0 to 19.2;
< 0.001) more correct answers. The PRODECIDE education program can improve the knowledge of legal representatives, an important prerequisite for evidence-based, informed decision-making.
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. The current study aimed to validate MAPPinfo. 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. 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. 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.
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.
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).
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.
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.
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.
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.
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%).
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.
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.
1.
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.
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.
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.
The evidence-based guideline entitled guideline evidence-based health information emerged from the German Network for Evidence-based Medicine (DNEbM) and was published in February 2017. The guideline ...addresses providers of health information and its goal is to improve the quality of health information. In addition, we explored the competences of providers of health information and developed a training programme. The aim of this study is to evaluate the efficacy of a training programme addressing providers of health information to support the application of the guideline evidence-based health information. We expected the intervention to improve the quality of health information in comparison to the provision of the guideline on its own.
The trial uses a superiority randomised control group design with 10 months' follow-up. Twenty-six providers of health information (groups with up to ten members) will be enrolled to compare the intervention (guideline and training programme) with usual care (a publicly available guideline). The 5-day training programme comprises an evidence-based medicine training module and a module to prepare the application of the guideline. The primary outcome parameter is the quality of the health information. Quality is operationalised as the extent of adherence to the guideline's recommendations. Each provider will prepare a single health information item informing a health-related decision on a topic freely chosen before randomisation. The quality of this information will be rated using the Mapping Health Information Quality (MAPPinfo) Checklist. An accompanying process evaluation will then be conducted.
The study results should show whether the efficacy of the intervention justifies implementation of the training programme to enhance health information developers' competences in evidence-based medicine and to ensure high-quality evidence-based health information (EBHI) in the long term.
ISRCTN registry, ID: ISRCTN96941060. Registered on 7 March 2019.
In Germany, the guardianship system provides adults who are no longer able to handle their own affairs a court-appointed legal representative, for support without restriction of legal capacity. ...Although these representatives only rarely are qualified in healthcare, they nevertheless play decisive roles in the decision-making processes for people with dementia. Previously, we developed an education program (PRODECIDE) to address this shortcoming and tested it for feasibility. Typical, autonomy-restricting decisions in the care of people with dementia-namely, using percutaneous endoscopic gastrostomy (PEG) or physical restrains (PR), or the prescription of antipsychotic drugs (AP)-were the subject areas trained. The training course aims to enhance the competency of legal representatives in informed decision-making. In this study, we will evaluate the efficacy of the PRODECIDE education program.
A randomized controlled trial with a six-month follow-up will be conducted to compare the PRODECIDE education program with standard care, enrolling legal representatives (N = 216). The education program lasts 10 h and comprises four modules: A, decision-making processes and methods; and B, C and D, evidence-based knowledge about PEG, PR and AP, respectively. The primary outcome measure is knowledge, which is operationalized as the understanding of decision-making processes in healthcare affairs and in setting realistic expectations about benefits and harms of PEG, PR and AP in people with dementia. Secondary outcomes are sufficient and sustainable knowledge and percentage of persons concerned affected by PEG, FEM or AP. A qualitative process evaluation will be performed. Additionally, to support implementation, a concept for translating the educational contents into e-learning modules will be developed.
The study results will show whether the efficacy of the education program could justify its implementation into the regular training curricula for legal representatives. Additionally, it will determine whether an e-learning course provides a valuable backup or even alternative learning strategy.
TRN: ISRCTN17960111 , Date: 01/06/2017.
IntroductionHealth information is a prerequisite of informed decision-making. Criteria for development, content and presentation have recently been published in a corresponding guideline. Within a ...systematic search, 27 relevant checklists were identified, none of them, however, complying with the guideline or providing reasonably operationalised measurement items. Therefore, a draft of a checklist with 19 criteria was drafted. The current study aims at developing and validating this measure of quality.Methods and analysisThe validation design consists of five single studies to be conducted at the University of Halle-Wittenberg/Germany and Graz/Austria. (1) Achieving content validity through expert reviews of the first draft, (2) achieving feasibility using ‘think aloud’ in piloting with untrained users, (3) pretesting the instrument applied to health information materials without use of secondary sources: determining inter-rater reliability and criterion validity, (4) determining construct validity using information on proceedings and methods in the development process provided by the developers and (5) determining divergent validity in comparison with the Ensuring Quality Information for Patients (EQUIP) (expanded) Scale. The substudies will use varying samples of experts, students and developers and will apply the instrument to materials of various domains. Sample sizes will be adjusted to the particular research designs and questions. Analyses will employ qualitative methods, such as content analyses and discourse within the expert panel, and correlation-based methods both for determining inter-rater reliability and validity.Ethics and disseminationThe project is approved by the ethics committee of the Martin Luther University Halle-Wittenberg (approval number: 2019 115). Results will be published, and the instrument made accessible on public health platforms. It is meant to become a certification standard. MAPPinfo can be used as a screening instrument without training or secondary sources. Although developed in the German language, the instrument will be applicable also in other languages.Trial registration numberAsPredected22546; date of registration: 24 July 2019.Protocol versionJuly 2020.
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