Evidence-based Patient Information Research Articles

Determinants of practice for providing decision coaching to facilitate informed values-based decision-making: protocol for a mixed-methods systematic review

IntroductionDecision coaching is a non-directive approach to support patients to prepare for making health decisions. It is used to facilitate patients’ involvement in informed values-based decision-making and use of evidence-based...

Acceptability of a digital health application to empower persons with multiple sclerosis with moderate to severe disability: single-arm prospective pilot study

BackgroundMany persons with multiple sclerosis (pwMS) desire to learn how health behaviour changes (e.g., dietary adjustments, physical activity, improvements in stress management) might help them manage their disease. Previous research has shown that certain health behaviour changes can improve quality of life (QoL), fatigue and other MS outcomes. Digital health applications may be well suited to deliver relevant health behavioural interventions because of their accessibility and flexibility. The digital health application “levidex” was designed to facilitate health behaviour change by offering evidence-based patient information and cognitive-behavioural therapy techniques to pwMS. By doing so, levidex aims to improve QoL and MS symptoms such as fatigue and mental health.ObjectivesA previous study reported on the development of levidex; this non-randomised pilot study examined the feasibility (practicability and acceptability) of levidex in pwMS with moderate to severe disability. Furthermore, the intervention’s impact on empowerment, stress management, and relevant health behaviours (e.g., dietary behaviour, physical activity) was explored.Methodslevidex was originally developed for newly diagnosed pwMS in the first year after diagnosis and eventually modified to offer access to pwMS with moderate to severe disability. Participants (n = 43) with an Expanded Disability Status Scale between 3.5 and 7.5 and a disease duration of more than one year were eligible to participate. The intervention was used over a period of six months with measurement time points at baseline, month 3 and month 6.ResultsOut of 38 participants who completed the six-month intervention period, 18 (47.4%) completed all 16 modules and 9 (23.7%) reached modules 13–16, the long-term maintenance part of levidex. Participants rated levidex positively in terms of practicability and acceptability and had only few points of criticism such as to include more physical exercise routine suggestions suitable for participants with severe impairment. Data on secondary endpoints showed no significant changes.ConclusionThis pilot study provided evidence for the practicability and acceptability of levidex, a digital health application designed to facilitate health behaviour change in pwMS with moderate to severe disability. Adequately powered randomised controlled studies with longer follow-up periods are needed to clarify the benefit of levidex in pwMS with moderate to severe disability.Trial registrationGerman Clinical Trials Register (DRKS) DRKS00032667 (14/09/2023); Retrospectively registered.

Experiences and Perceptions of Medical Cannabis among People Living with Chronic Pain and Community Pharmacists: A Qualitative Study in Canada

ABSTRACT Background The use of cannabis to treat chronic pain is under debate despite high expectations from patients. Qualitative data obtained by exploring both patients’ and health professionals’ perspectives are scarce. Aims This study aimed to understand the experiences and perceptions of people living with chronic pain and community pharmacists regarding the role of cannabis in chronic pain treatment in the Canadian context where both medical and recreational cannabis are legal. Methods We conducted 12 online focus groups (July 2020–February 2021) with 26 patients and 19 community pharmacists using semistructured discussion guides. All discussions were audio recorded and transcribed verbatim were analyzed using a reflexive thematic approach. Results We developed three themes related to patients’ perspectives and three themes related to pharmacists’ perspectives. Patients’ perspectives included (1) cannabis as an alternative to other pain medications, (2) a new treatment with potential health-related risks, and (3) a therapy rather than a recreational drug. Pharmacists’ perspectives included (1) challenges in monitoring drug interactions with cannabis in the context of scarce research data, (2) informing and treating patients self-medicating with cannabis amid its growing popularity, and (3) financial costs and legal constraints for patients. Conclusions This study highlights patients’ and pharmacists’ urgent need for reliable information regarding the benefits and risks of cannabis. Training tailored to pharmacists’ needs and evidence-based information for patients should be developed to support pharmacists’ practice, improve patients’ experiences, and promote safe cannabis use.

Information needs of patients with atopic eczema-aqualitative study

Often patient information in atopic eczema (AE) does not meet the criteria of evidence-based patient information. What are the information needs of affected patients? The aim of the study was to analyze opinions and experiences of AE patients regarding their personal information needs. In all, 16semi-structured interviews were conducted with patients with AE based on an interview guide. Subsequently the audio-taped interviews were transcribed and analyzed using deductive-inductive methods. Standards of qualitative research were ensured using the consolidated criteria for reporting qualitative research (COREQ). In all, 21persons participated in the 16interviews, including patients and relatives. Gender ratio was 2 : 1 (female/male); age varied between 19and 75years. The interviews revealed agap in care for patient information about AE. Especially the lack of time in the physician-patients encounter was criticized. Many of the affected felt left alone and forced to take amore active role in the search for information and therapy itself. Depending on stage and duration of the disease, some persons had the impression that their search for information was too time-consuming in relation to the possible benefits. Patients perceived their doctor to be the most important contact person during the information seeking process. Within our study group, feeling alack of acaring contact person as well as alack of knowledge often led to not complying with astandardized, guideline-orientated therapy and of self-treatment. Filling this care gap seems to be an important approach to optimized patient care.

A multicenter noninferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stage IB3 and IIA2): study protocol of the LAUNCH 3 trial

BackgroundCervical cancer is and will remain to be an important health problem in China, especially with an increasing proportion of younger patients who has more specific needs. In China, surgery to remove tumor burden followed by postoperative treatment with radiotherapy and chemotherapy based on clinicopathologic factors may be the best choice for stages IB3 and IIA2 patients. Radical hysterectomy in cervical cancer has been a classic landmark surgery in gynecology. The current trial is designed to evaluate whether there is a difference between laparoscopic RH and abdominal RH in cervical cancer (stages IB3 and IIA2) patient survival under stringent operation standards and consistent surgical oncologic principles. This paper reports the rationale, design, and implementation of the trial.Methods/designThis is an investigator-initiated, prospective, randomized, open, blinded endpoint (PROBE) controlled trial. A total of 1104 patients with stage IB3 and IIA2 cervical cancer will be enrolled over a period of 3 years. Patients are randomized (1:1) to either the laparoscopic RH or the abdominal RH group. Patients will then be followed up for at least 5 years. The primary end point will be 5-year overall survival, and secondary endpoints include 5-year progression-free survival, recurrence, and quality of life measurements.DiscussionThe study results will provide more convincing evidence-based information for stages IB3 and IIA2 cervical cancer patients and their gynecologic cancer surgeons in their choice of surgical method.Trial registrationClinicalTrials.gov, NCT04939831, retrospectively registered on 25 June 2021.

How breast cancer therapies impact body image – real-world data from a prospective cohort study collecting patient-reported outcomes

BackgroundIn breast cancer patients body image (BI) is a crucial aspect of quality of life (QoL). This study examined the postoperative impact of different surgical approaches on long-term BI analyzing real-world data to guide pre- and postoperative patient care and preserve QoL.MethodsEORTC QLQ-BR23 BI scores were collected electronically in 325 breast cancer patients within routine clinical care for a duration of 41.5 months (11/17/2016 – 4/30/2020) at predefined time points preoperatively and repeatedly up to two years after breast-conserving surgery (BCS) (n = 212), mastectomy alone (M) (n = 27) or mastectomy with immediate breast reconstruction (MIBR) (n = 86). Higher scores indicated better BI. A linear mixed regression model was used to analyze the impact of BCS, M and MIBR, as well as non-surgical therapies on BI at treatment initiation and over time.ResultsBI scores deteriorated by 5 points (95%-confidence interval (CI) -8.94 to -1.57, p≈0.005) immediately after BCS, by 7 points (95%-CI -12.13 to -1.80, p≈0.008) after MIBR and by 19 points (95%-CI -27.34 to -10.34, p < 0.001) after M. The change over time after BCS (+ 0.10 points per week, 95%-CI -0.17 to 0.38), MIBR (-0.07 points per week, 95%-CI -0.35 to 0.20) and M (+ 0.14 points per week, 95%-CI -0.19 to 0.48) were not statistically significant (each p > 0.05). At treatment initiation chemotherapy was associated with a 22-point decline (95%-CI -25.39 to -17.87, p < 0.001) in BI score, while radiotherapy was associated with a 5-point increase (95%-CI 1.74 to 9.02, p≈0.004). However, over time chemotherapy was associated with a score recovery (+ 0.28 points per week, 95%-CI 0.19 to 0.37, p < 0.001), whereas for radiotherapy a trend towards BI deterioration was observed (-0.11 points per week, 95%-CI -0.23 to 0.02, p≈0.101).ConclusionsBreast cancer surgery negatively affects BI. BCS and MIBR presumably harm BI less than M in the early postoperative period. Our data suggests BI to be deteriorating in the long term after MIBR while improving after BCS or M. Radiotherapy seems to have an additional negative long-term impact on BI. These findings should be confirmed in further studies to enable evidence-based patient information as part of preoperative shared decision-making and postoperative patient care.

Evidence-based health information about pulmonary embolism: Assessing the quality, usability and readability of online and offline patient information.

Pulmonary embolism (PE) is the third most common cardiovascular disease worldwide. However, public awareness is considerably lower than for myocardial infarction or stroke. Patients suffering from PE complain about the lack of (understandable) information and express high informational needs. To uncover if reliable information is indeed scarce, this study evaluates the quantity and quality of existing patient information for tertiary prevention using an evidence-based health information paradigm. We conducted a quantitative content analysis (n = 21 patient information brochures; n = 67 websites) evaluating content categories addressed, methodical quality, usability, and readability. Results show that there is not enough patient information material focusing on PE as a main topic. Existing patient information material is mostly incomplete, difficult to understand, and low in actionability as well as readability. Our systematic analysis reveals the need for more high-quality patient information on PE as part of effective tertiary prevention. This is the first review analyzing content, methodical quality, readability, and usability of patient information on PE. The findings of this analysis are guiding the development of an innovative, evidence-based patient information on PE aiming to support patients' informational needs and their self-care behavior.

On the need for narratives in patient information: Differentiating types and functions of narratives from pulmonary embolism patients' point of view

The inclusion of narratives in evidence-based patient information is a heavily discussed topic in literature. Narratives elicit intense engagement and emotional insights, but may also cause unintended persuasion effects. There is mixed evidence that adding narratives to non-narrative factual patient information is valuable for patients. In addition, providing patients with narratives about the outcome of treatments has been found to bias treatment decisions, in line with the direction implied by the narratives. This may counteract informed decision making of patients. However, narratives about the process of a treatment and personal experiences with treatments may support the well-being of patients in tertiary prevention. In order to investigate patients' views on narratives and their function in patient information, we conducted 26 semi-structured qualitative interviews with pulmonary embolism patients. Answers were coded using thematic analysis. Results show that patients are especially interested in experience and process narratives when combined with evidence-based patient information. We identified four main functions of experience and process narratives that patients ascribe to these narratives: (1) motivating self-reflection and reflection on the recovery process, (2) reducing the feeling of loneliness, (3) reducing emotional distress, and (4) inspiring mindful mastery.

A multicenter non-inferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stages IB1, IB2, and IIA1): study protocol of the LAUNCH 2 trial

BackgroundA retrospective study and a randomized controlled trial published in late 2018 have shown that laparoscopic radical hysterectomy (RH) was associated with worse survival than abdominal RH among patients with early-stage cervical cancer. Radical hysterectomy in cervical cancer has been a classic landmark surgery in gynecology; therefore, this conclusion is pivotal. The current trial is designed to reconfirm whether there is a difference between laparoscopic RH and abdominal RH in cervical cancer (stages IB1, IB2, and IIA1) patient survival under stringent operation standards and consistent surgical oncologic principles.Methods/designThis is an investigator-initiated, Prospective, Randomized, Open, Blinded End-point (PROBE)-controlled non-inferiority trial. A total of 780 patients with stage IB1, IB2, and IIA1 cervical cancer will be enrolled over a period of 3 years. Patients are randomized (1:1) to either the laparoscopic RH or the abdominal RH group. Patients will then be followed up for at least 5 years. The primary endpoint will be 5-year progression-free survival, and secondary endpoints include 5-year overall survival, recurrence, and quality of life measurements.DiscussionThe debate on laparoscopic versus abdominal RH is still ongoing, and high-quality evidences are needed to guide clinical practice. The study results will provide more convincing evidence-based information for early-stage cervical cancer patients and their gynecologic cancer surgeons in their choice of surgical method.Trial registrationClinicalTrials.govNCT04929769. Registered on 18 June 2021

Understanding Magnetic Resonance Imaging in Multiple Sclerosis (UMIMS): Development and Piloting of an Online Education Program About Magnetic Resonance Imaging for People With Multiple Sclerosis.

BackgroundPeople with multiple sclerosis (pwMS) lack sufficient magnetic resonance imaging (MRI) knowledge to truly participate in frequently occurring MRI-related therapy decisions. An evidence-based patient information (EBPI) about MRI is currently lacking.ObjectiveThe aim of this study was to develop an evidence-based online education program about limitations and benefits of MRI for pwMS. Ultimately, our goal was to improve MRI risk-knowledge, empower pwMS, and promote shared decision-making.MethodsThe program's contents were based on literature research and a previous pilot study. It was revised following 2 evaluation rounds with pwMS, MRI experts and expert patients. In a pilot study, n = 92 pwMS received access to the program for 4 weeks. User experiences and acceptance, MRI knowledge (MRI-RIKNO 2.0 questionnaire) and emotions and attitudes toward MRI (MRI-EMA questionnaire) were assessed. Results were compared to a previous survey population of n = 508 pwMS without access to the program.ResultsParticipants rated the program as easy to understand, interesting, relevant, recommendable, and encouraging. In comparison to pwMS without access to the program, MRI risk-knowledge and perceived MRI competence were higher.ConclusionSatisfaction with the program and good MRI-risk knowledge after usage demonstrates the need and applicability of EBPI about MRI in MS.

Development and evaluation of evidence-based patient information handbooks about multiple sclerosis immunotherapies

BackgroundMultiple sclerosis treatment options are increasing. Evidence-based patient information (EBPI) are therefore crucial to enable patient involvement in decision making. Based on earlier work on decision support, patient information handbooks on 8 MS immunotherapies were developed, piloted and evaluated with support from the German Clinical Competence Network MS and the German MS Society. MethodsHandbooks were structured according to EBPI concepts. Drafts were commented by patient representatives and neurologists with an MS expertise. Executive boards of the German MS Society and the Competence Network as well as pharmaceutical companies’ feedback was included. Handbooks were distributed among MS neurologists by the German MS Society. Evaluation followed applying a mixed methods approach with interviews, focus groups and surveys. One survey addressed persons with MS (pwMS) based on a questionnaire included in each handbook. Neurologists who received printed patient handbooks were invited to give feedback in a second survey. ResultsEight handbooks were developed providing absolute and relative risk information in numbers and figures as well as monitoring needs and drug fact boxes. Despite the high amount of information and the display of low absolute risk reduction rates of treatments, handbooks were overall appreciated by pwMS (n=107) and mostly also by physicians (n=24). For more than 70% of the pwMS the information was new, understandable and supportive for decision making. But patients felt uncomfortable with relative risk information. However, response rates in the evaluation were low, exposing the challenges when implementing EBPI into clinical care. Therefore, conclusions must be considered preliminary. ConclusionEBPI on immunotherapies for MS seem feasible and are appreciated by patients and treating neurologists but more implementation research is needed.

Risk communication in acute stroke patients – from qualitative data to a pilot randomised controlled trial

ObjectivesThe probability of recurring strokes in patients with atrial fibrillation is high. Within 1.8 years, 6.6 % of the patients suffered a new stroke. While effective secondary prevention options exist, low adherence challenges effective medical treatment.The aim of our study was to examine the risk understanding of acute stroke patients and to find the best way to communicate risk reduction. Materials and MethodsRisk communication had three formats: a text, a pictogram, and a cube diagram. All three were developed on the basis of the criteria of evidence-based patient information. Patients who were admitted to the stroke unit and diagnosed with acute stroke, assessed the information material. Data on secondary prevention using acetylsalicylic acid were taken as an example, with no reference to actual patient treatment. In a first step, we interviewed a focus group to check the feasibility of the questionnaire (qualitative study). In the second step, the information material was tested in a pilot randomized controlled trial. ResultsAcute stroke patients (qualitative study, n=13) understood the information and were interested in numerical risk communication. The visualized representations were superior in terms of understandability of the numbers communicated (pilot randomized controlled trial, n=60, 50 % correct answers for question 1, p value of 0.502, and 55 % correct answers for question 2, p value of 0.338).Stroke-related neurologic deficits, measured with the National Institute of Health Stroke Scale (NIHSS) on admission, revealed a significant influence on the number of correct answers to stroke risk questions, whereas the type of stroke and education did not. ConclusionsAcute stroke patients were able to understand risk communication. Visualization helped them capture information on stroke risk.

Nurse-led decision coaching by specialized nurses for healthy BRCA1/2 gene mutation carriers\xa0- adaptation and pilot testing of a curriculum for nurses: a qualitative study

BackgroundWomen 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.MethodsThe 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.ResultsThe 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.ConclusionsSpecialized 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 registrationThe main trial is registered under DRKS-ID: DRKS00015527.

An audit, literature review and quality improvement project regarding post-operative aftercare of facial lacerations in children

Aims & objectivesTo evaluate the communication of post-procedural instructions following repair of paediatric facial lacerations and design a post-procedural informative package to streamline and improve patients’ post-operative care. Methods1. Quantitative analysis of clinical records of 50 patients who underwent facial laceration repair, to evaluate clinical documentation 2. Informal survey of OMFS staff regarding perceived shortcomings of communicating post-procedural instructions to these patients’ parents 3. Literature review on post-procedure instructions after facial laceration repair. Results34% of clinical records had no mention of post-operative instructions given to patient’s parents. 38% had a non-specific mention: “post-operative instructions given”. Specific instructions were recorded as given in between 16-43% of clinical notes. DiscussionThese shortcomings were exacerbated by an increase in cases during lockdown and the timing of presentation- majority ‘out of hours’. We designed and implemented a pack to address this - an evidence-based patient information leaflet with an analgesic (Calpol), in collaboration with the hospital pharmacy and Patient Experience team. We noted, importantly, that routine use of Chloramphenicol is not endorsed by NICE. ConclusionThis audit highlighted the importance of heterogeneity of post-procedural instructions and documentation. Our simple intervention eases DCT burden, streamlines care and improves patient outcomes.

'That would have been the perfect thing after diagnosis': development of a digital lifestyle management application in multiple sclerosis.

Background:A multiple sclerosis (MS) diagnosis urges decision-making on immunotherapies, while persons with MS (PwMS) need to develop a coping concept in parallel. At this stage, PwMS ask how they themselves may contribute to controlling the disease. Evidence suggests that maintaining a healthy lifestyle (e.g. physical activity and stress management) is a key factor for healthy aging and preserving activity, while data on MS are complex.Objectives:Following the Medical Research Council framework, this study aimed to develop and investigate the feasibility of a new digital health application that conveys evidence-based patient information about lifestyle factors in MS and engages PwMS in relevant behaviour change techniques.Methods:Based on a digital health application promoting lifestyle management in breast cancer survivors, an MS-specific adaptation (‘levidex’) was developed. Feasibility was tested with 15 PwMS and eight MS experts. Subsequently, a six-week pilot study with eight PwMS was conducted. All participants provided feedback on practicability and acceptability via a questionnaire and took part in a semi-structured telephone interview. Levidex was revised after each test phase.Results:The final levidex tool includes 16 modules, 177 references and several other functions. Feasibility results showed that PwMS and MS experts perceived levidex as understandable (14 out of 15; 6 out of 8), trustworthy (15 out of 15; 8 out of 8), and relevant (10 out of 15; 8 out of 8). Interviews revealed potential for improvement regarding the length and complexity of some content. Piloting of the revised version confirmed good feasibility and high acceptance. Most participants felt inspired to initiate (7 out of 8) or had already implemented (5 out of 8) lifestyle changes after working with levidex.Conclusion:Results suggest that levidex is feasible and well-accepted by PwMS and MS experts. It might be a useful tool to support PwMS in adapting to their diagnosis and initiating health-promoting lifestyle changes.

Evidence Map of Pancreatic Surgery–A living systematic review with meta-analyses by the International Study Group of Pancreatic Surgery (ISGPS)

BackgroundPancreatic surgery is associated with considerable morbidity and, consequently, offers a large and complex field for research. To prioritize relevant future scientific projects, it is of utmost importance to identify existing evidence and uncover research gaps. Thus, the aim of this project was to create a systematic and living Evidence Map of Pancreatic Surgery. MethodsPubMed, the Cochrane Central Register of Controlled Trials, and Web of Science were systematically searched for all randomized controlled trials and systematic reviews on pancreatic surgery. Outcomes from every existing randomized controlled trial were extracted, and trial quality was assessed. Systematic reviews were used to identify an absence of randomized controlled trials. Randomized controlled trials and systematic reviews on identical subjects were grouped according to research topics. A web-based evidence map modeled after a mind map was created to visualize existing evidence. Meta-analyses of specific outcomes of pancreatic surgery were performed for all research topics with more than 3 randomized controlled trials. For partial pancreatoduodenectomy and distal pancreatectomy, pooled benchmarks for outcomes were calculated with a 99% confidence interval. The evidence map undergoes regular updates. ResultsOut of 30,860 articles reviewed, 328 randomized controlled trials on 35,600 patients and 332 systematic reviews were included and grouped into 76 research topics. Most randomized controlled trials were from Europe (46%) and most systematic reviews were from Asia (51%). A living meta-analysis of 21 out of 76 research topics (28%) was performed and included in the web-based evidence map. Evidence gaps were identified in 11 out of 76 research topics (14%). The benchmark for mortality was 2% (99% confidence interval: 1%–2%) for partial pancreatoduodenectomy and <1% (99% confidence interval: 0%–1%) for distal pancreatectomy. The benchmark for overall complications was 53% (99%confidence interval: 46%–61%) for partial pancreatoduodenectomy and 59% (99% confidence interval: 44%–80%) for distal pancreatectomy. ConclusionThe International Study Group of Pancreatic Surgery Evidence Map of Pancreatic Surgery, which is freely accessible via www.evidencemap.surgery and as a mobile phone app, provides a regularly updated overview of the available literature displayed in an intuitive fashion. Clinical decision making and evidence-based patient information are supported by the primary data provided, as well as by living meta-analyses. Researchers can use the systematic literature search and processed data for their own projects, and funding bodies can base their research priorities on evidence gaps that the map uncovers.

An Exploration On-demand Article Recommender System for Cancer Patients Information Provisioning

&#x0D; &#x0D; &#x0D; Information provision plays an important role in ed- ucating patients with serious illnesses, like cancer, to cope with their disease conditions and to actively partic- ipate in shared-decision making process. Recent stud- ies suggest that there is a lack of appropriate educa- tional resources for such patients, specifically prostate cancer patients. To address this issue, in this paper, a Knowledge-based Exploration on-demand article Rec- ommender System (called KERS) is proposed that can provide evidence-based information for patients. Rec- ognizing the fact that exploration is expensive when the user of the system is a human, the main idea in KERS is to minimize exploration while achieving the maximum long-term satisfaction. Therefore, using a knowledge- base developed by an expert in the field, KERS learns user interests as quickly as possible and then it ex- ploits this knowledge to recommend the best articles. Furthermore, KERS needs no information from users beforehand and it learns them through interacting with users. The system will help patients make informed de- cisions, and at the same time, will reduce the burden on the healthcare providers. The results of experiments have confirmed the effectiveness of the proposed system compared to baseline methods.&#x0D; &#x0D; &#x0D;

Patient information portal for congenital aortic and pulmonary valve disease: a stepped-wedge cluster randomised trial

BackgroundIn response to an increased need for patient information in congenital heart disease, we previously developed an online, evidence-based information portal for patients with congenital aortic and pulmonary valve disease....

Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWER@MS2)\u2014study protocol for a randomised controlled trial

IntroductionMultiple sclerosis is a chronic inflammatory, degenerative disease of the central nervous system manifesting at first with relapses in about 85% of cases. In Germany, intravenous therapy with high-dose corticosteroids is the treatment standard of acute relapses. The treatment leads to a faster reduction of symptoms in about 25 of 100 treated patients but has no proven long-term benefits over placebo treatment. Intravenous treatment is not superior to oral treatment. Therefore, informed decisions on relapse management are required. An earlier randomised controlled trial showed that evidence-based patient information and education on relapse management leads to more informed decisions and more relapses not treated or treated with oral corticosteroids. This study aims to evaluate whether a web-based relapse management programme will positively change relapse management and strengthen autonomy in people with multiple sclerosis.MethodsThe pragmatic double-blind randomised controlled trial is accompanied by a mixed-methods process evaluation and a health economic evaluation and follows the UK Medical Research Council guidance on developing and evaluating complex interventions. A total of 188 people with possible or relapsing-remitting multiple sclerosis with ≥ 1 relapse within the last year and/or ≥ 2 relapses within the last 2 years will be recruited and randomised using blocks. The intervention group receives a web- and dialogue-based decision aid on relapse management, a nurse-led webinar and access to a monitored chat forum. The control group receives standard information, which will be made available via the same online platform as the intervention. The primary endpoint is the proportion of relapses not treated or treated with oral corticosteroids. Key secondary endpoints are the annualised relapse rate, decision-making, empowerment, quality of life and cost-effectiveness. Facilitators and barriers will be assessed by mixed-methods process evaluation measures. The study ends when 81 relapses have been documented or after 24 months of observation per individual patient. Analyses will follow the intention-to-treat principle.DiscussionWe hypothesise that the intervention will enhance patient empowerment and have a positive impact on patients’ relapse management.Trial registrationClinicalTrials.govNCT04233970. Registered on 18 January 2020

Impact of a multimedia website with patient experiences of multiple sclerosis (PExMS) on immunotherapy decision-making: study protocol for a pilot randomised controlled trial in a mixed-methods design

BackgroundA variety of management options (e.g. immunotherapies, lifestyle interventions, and rehabilitation) are available for people with relapsing-remitting multiple sclerosis (RRMS). Besides coping with the diagnosis, people with MS (pwMS) have to make complex decisions such as deciding about immunotherapies. In addition to factual information, reports of patient experiences (PEx) may support patients in decision-making. The added value of PEx in decision-making is not clear, and controlled studies are rare. Therefore, systematic methods are necessary to develop and analyse PEx. As there are no evaluated PEx for MS in Germany, we are currently creating a website presenting PEx structured according to topics and illustrated by video, audio, and text files. We aim to determine the feasibility of an intervention using PEx and evaluate whether PEx may help pwMS in their immunotherapy decision-making processes as a supplement to evidence-based information.MethodsThis project will follow the Medical Research Council framework for development and evaluation of complex interventions. After the development of a website with PEx, a randomised controlled pilot trial (pilot RCT) will be conducted in 2–3 MS centres, clinics, or rehabilitation centres including 55 pwMS and accompanied by a process evaluation. Patients with a RRMS diagnosis considering immunotherapy are eligible. The primary outcome is decision self-efficacy. Secondary outcomes include preparation for decision-making, decisional conflict, risk knowledge, confidence in active participation, affective forecasting, social support, and self-reported impact of eHealth on its users. Participants will be randomly assigned either to (i) an intervention group with 4 weeks access to an evidence-based patient information resource and the PExMS-website as an adjunct or to (ii) the control group with access to evidence-based information alone. A 6-member advisory panel involving representatives of pwMS, researchers, and neurologists, who accompany the whole project, will mentor this pilot RCT.DiscussionThe intervention was developed with systematic methods, created with active patient involvement and in critical appraisal by an expert advisory panel. The study is innovative as it contributes to the controversial evidence on the use of PEx in the context of evidence-based patient information.Trial registrationClinicalTrials.gov, NCT04236544