Multidisciplinary Steering Group Research Articles

Addressing barriers to global multidisciplinary stakeholder inclusivity: Lessons from global orofacial cleft research priority setting.

Inclusivity in research priority setting is fundamental to capturing the opinion of all stakeholders in a research area. Globally, experienced healthcare workers often have deep insights that could impactfully shape future research, and a lack of their involvement in formal research and publications could mean that their voices are insufficiently represented. We aimed to modify the well-established Child Health and Nutrition Research Initiative (CHNRI) methodology to address barriers to inclusivity, which are particularly relevant in healthcare that requires highly multidisciplinary care. This global research priority-setting exercise for orofacial clefts adapted the CHNRI methodology to include research experts, clinicians from multiple disciplines, and non-technical stakeholders (i.e. patients and parents and non-governmental organisations (NGOs)) on a global basis. A multidisciplinary international steering group proposed and discussed methodological changes to improve inclusivity, including survey edits, subgroups for research questions, a demographics section, translation in French and Spanish, phrasing adaptation, and alternative dissemination techniques. We received 412 responses and 1420 questions, spanning 78 different countries and 18 different specialties/groups. Challenges remain to improve representation of all groups, with the vast majority of answers (30%) being from surgeons and a comparatively small proportion from patient/parent groups (9%). This also includes managing responses in three languages, effective dissemination, and responses that were not worded as research questions. This is one of the first CHNRI exercises to involve patients and parents, clinicians, and researchers in its first question submission stage, and the first ever to do so on a global scale. We describe our approach to addressing inclusivity challenges and report related demographic data to serve as a benchmark upon which we hope future CHNRI exercises will improve.

Development of a patient decision aid for children and adolescents following anterior cruciate ligament rupture: an international mixed-methods study

AimTo develop and user test an evidence-based patient decision aid for children and adolescents who are considering anterior cruciate ligament (ACL) reconstruction.DesignMixed-methods study describing the development of a patient decision...

Real-time x-ray abnormality alerts for emergency departments using a radiographer comment model - a multisite pilot study

IntroductionThe timely communication of clinically significant image appearances to Emergency Department (ED) referrers is necessary for optimum patient care. Australian reliance on verbal communication only is time-limited, open to misinterpretation and lacks transparency. A combined radiographer alert and comment model was designed to reliably communicate image abnormalities to ED referrers in real-time. MethodsA multidisciplinary steering group designed the model for all ED general imaging. Protocols were developed to document radiographer comments (critical, urgent and clinically significant) in patients’ medical records. Critical findings were communicated directly to ED.Five NSW hospitals varying in size, complexity and population demographics piloted the model between three to twelve months during 2021–2022.Site auditors compared comments with the radiology report and designated each as True Positive (TP), False Positive (FP), indeterminate and clinically significant. Indeterminate cases were analysed by an external radiologist. Inter-observer consensus was obtained for all classifications via two independent auditors. The Positive Predictive Value (PPV), or precision of the comment, was calculated for each site. ResultsRadiographers (n = 69) provided comments for 1102 cases. The pooled average PPV for TP was 0.96; (0.947–0.971; 95% CI). The weighted mean error (FP comments) was 3.9%; (2.9% - 5.3%.; 95% CI). ConclusionThe Radiographer Comment model provided consistent levels of commenting precision and reproducibility across a range of sites with a pooled average PPV (0.96). The False Positive rate or weighted mean error (FP) of 3.9% (2.9% - 5.3%.; 95% CI) was low. Implications for future practiceA strategic, interprofessional approach in the implementation of an image alert combined with a Radiographer Comment can be adapted across a variety of hospital settings for ED and other departments.

Developing a patient decision aid for Achilles tendon rupture management: a mixed-methods study

ObjectiveTo develop and user-test a patient decision aid portraying the benefits and harms of non-surgical management and surgery for Achilles tendon ruptures.DesignMixed methods.SettingA draft decision aid was developed using guidance...

Impact of a quality improvement intervention on the incidence of surgical site infection in patients undergoing colorectal surgery: Pre-test-post-test design.

The aim of this study was to measure the impact of a complex quality improvement intervention on the incidence of SSI in patients undergoing elective colorectal surgery. Surgical site infections are a major postoperative complication for patients undergoing colorectal surgery. Prevention of SSIs necessitates a complex intervention requiring many elements to be in place to ensure the successful implementation of prevention measures. This study was a non-equivalent pre-test post-test design where consecutive patients undergoing colorectal surgery were surveyed for surgical site infections for 30 days postoperatively and is reported using the SQUIRE 2.0. A baseline cohort of patients was retrospectively reviewed in a single centre to ascertain the surgical site infection incidence rate in the first 6 months of 2018 (T0) and prospectively at two 6-month time periods in 2019 (T1, T2) following the introduction of a complex intervention. There were 311 patients included across three time periods. There was a notable decrease in surgical site infection incidence rates from baseline over the course of the study. Univariate analysis identified Body Mass Index, a wound contamination classification of dirty or contaminated, duration of surgery >75th percentile and a National Healthcare Safety Network risk index score of 3 as factors that significantly increase the probability of developing a surgical site infection. Multivariate analysis identified duration of surgery and body mass index increased the probability of an SSI. The results of the logistical regression model found that there was a significant reduction in the probability of an SSI between T0 and T2. The implementation of a complex intervention led to a reduction in the incidence of surgical site infections and improved implementation of evidence-based practices as part of a care bundle in relation to the prevention of surgical site infections in patients undergoing elective colorectal surgery. A multicomponent multidisciplinary complex intervention as part of a quality improvement project can successfully reduce the incidence rates of surgical site infections in patients who require elective colorectal surgery. Normalisation Process Theory provides guidance and support in implementing complex interventions for the prevention of surgical site infection. Patients provided post-discharge information on their wound healing as part of the surveillance component of the intervention. Five patients reviewed and provided feedback on a patient information booklet which was developed from this quality improvement intervention. A multidisciplinary steering group guided all stages of the project.

The Scottish transport and industry collections knowledge network (STICK)

The Scottish Transport and Industry Collections Knowledge Network (STICK) brings together a range of organisations and individuals who share a common interest in transport and industrial collections and promoting their care and enjoyment. While a multi-disciplinary steering group drives it forward, STICK is its members and their passion and knowledge. STICK facilitates shared learning and knowledge exchange through projects, events and active communication that have drawn on the knowledge and expertise of participants to achieve the aims of the group. STICK’s engaged membership and the success of its projects demonstrate the network’s strengths but, as an informal body, it faces various challenges as well. It is looking to use learning from its work to date, along with the combined experience and needs of its steering group and members, to address these challenges and continue to bring people together and achieve good outcomes for the sector in the future.

Supporting Shared Decision-making About Surveillance After Breast Cancer With Personalized Recurrence Risk Calculations: Development of a Patient Decision Aid Using the International Patient Decision AIDS Standards Development Process in Combination With a Mixed Methods Design.

Although the treatment for breast cancer is highly personalized, posttreatment surveillance remains one-size-fits-all: annual imaging and physical examination for at least five years after treatment. The INFLUENCE nomogram is a prognostic model for estimating the 5-year risk for locoregional recurrences and second primary tumors after breast cancer. The use of personalized outcome data (such as risks for recurrences) can enrich the process of shared decision-making (SDM) for personalized surveillance after breast cancer. This study aimed to develop a patient decision aid (PtDA), integrating personalized risk calculations on risks for recurrences, to support SDM for personalized surveillance after curative treatment for invasive breast cancer. For the development of the PtDA, the International Patient Decision Aids Standards development process was combined with a mixed methods design inspired by the development process of previously developed PtDAs. In the development, 8 steps were distinguished: establishing a multidisciplinary steering group; definition of the end users, scope, and purpose of the PtDA; assessment of the decisional needs of end users; defining requirements for the PtDA; determining the format and implementation strategy for the PtDA; prototyping; alpha testing; and beta testing. The composed steering group convened during regular working-group sessions throughout the development process. The "Breast Cancer Surveillance Decision Aid" consists of 3 components that support the SDM process: a handout sheet on which personalized risks for recurrences, calculated using the INFLUENCE-nomogram, can be visualized and which contains an explanation about the decision for surveillance and a login code for a web-based deliberation tool; a web-based deliberation tool, including a patient-reported outcome measure on fear of cancer recurrence; and a summary sheet summarizing patient preferences and considerations. The PtDA was assessed as usable and acceptable during alpha testing. Beta testing is currently ongoing. We developed an acceptable and usable PtDA that integrates personalized risk calculations for the risk for recurrences to support SDM for surveillance after breast cancer. The implementation and effects of the use of the "Breast Cancer Surveillance Decision Aid" are being investigated in a clinical trial.

The Codevelopment of "My Kidneys & Me": A Digital Self-management Program for People With Chronic Kidney Disease.

Health care self-management is important for people living with nondialysis chronic kidney disease (CKD). However, the few available resources are of variable quality. This work describes the systematic codevelopment of "My Kidneys & Me" (MK&M), a theory-driven and evidence-based digital self-management resource for people with nondialysis CKD, guided by an established process used for the successful development of the diabetes education program MyDESMOND (Diabetes Education and Self-Management for Ongoing and Newly Diagnosed, DESMOND). A multidisciplinary steering group comprising kidney health care professionals and researchers and specialists in the development of complex interventions and digital health provided expertise in the clinical and psychosocial aspects of CKD, self-management, digital health, and behavior change. A patient and public involvement group helped identify the needs and priorities of MK&M and co-design the resource. MK&M was developed in 2 sequential phases. Phase 1 involved the codevelopment process of the MK&M resource (content and materials), using Intervention Mapping (IM) as a framework. The first 4 IM steps guided the development process: needs assessment was conducted to describe the context of the intervention; intervention outcomes, performance objectives, and behavioral determinants were identified; theory- and evidence-based change methods and practical strategies to deliver change methods were selected; and program components were developed and refined. Phase 2 involved the adoption and adaptation of the existing MyDESMOND digital platform to suit the MK&M resource. The needs assessment identified that individuals with CKD have multiple differing needs and that delivering a self-management program digitally would enable accessible, tailored, and interactive information and support. The intended outcomes of MK&M were to improve and maintain effective self-management behaviors, including physical activity and lifestyle, improve knowledge, promote self-care skills, increase self-efficacy, and enhance well-being. This was achieved through the provision of content and materials designed to increase CKD knowledge and patient activation, reduce health risks, manage symptoms, and improve physical function. Theories and behavior change techniques selected include Self-Management Framework, Capability, Opportunity, Motivation Behavior model components of Behaviour Change Wheel and taxonomy of behavior change techniques, Health Action Process Approach Model, Common Sense Model, and Social Cognitive Theory. The program components developed comprised educational and behavior change sessions, health trackers (eg, monitoring blood pressure, symptoms, and exercise), goal-setting features, and forums for social support. The MyDESMOND digital platform represented an ideal existing platform to host MK&M; thus, the MyDESMOND interface and features were adopted and adapted for MK&M. Applying the IM framework enabled the systematic application of theory, empirical evidence, and practical perspectives in the codevelopment of MK&M content and materials. Adopting and adapting a preexisting platform provided a cost- and time-efficient approach for developing our digital intervention. In the next stage of work, the efficacy of MK&M in increasing patient activation will be tested in a randomized controlled trial.

Oncology-hospitalist co-management: A model for efficient, high-quality care and education.

1 Background: Our inpatient oncology service at Smilow Cancer Hospital had long lengths of stay, high readmission rates and burnout among outpatient oncologists who rotated as inpatient attendings. With a proposal to improve length of stay by.25 days in the first year, the health system funded the integration of internal medicine hospitalists. Methods: Patients were randomly assigned to one of two oncology teams, allowing for real time outcome comparisons. Hospitalists were added to the Intervention Team and served as the primary attending with oncologists as consultants; Oncologists served as the primary attending on the Traditional Team. The intervention began in July 2021. Outcome metrics included LOS, readmission rate, case volume, early discharge rate, educational rankings, and oncologist satisfaction. A multidisciplinary steering group met to review data, study, and act on outcome metrics. Using Quality Improvement PDSA cycles, outcomes were reported at 3 months (PDSA 1), followed by improvement interventions; then reported again at 6 months (PDSA 2). Results: The Intervention Team achieved a 1.0-day reduction in LOS compared to Traditional team. There was no difference in Severity of Illness score in comparator groups, demonstrating no imbalance in patient population. The Intervention team cared for a 29% higher volume of patients and improved early discharge rate without an increase in readmissions from baseline. Oncologists reported a high level of satisfaction with the program. Housestaff overall educational rankings increased after the introduction of hospitalists (Table). Discussion: Hospitalist comanagement exceeded business plan LOS reduction target without compromise in quality or educational metrics. PDSA 1 identified need for role clarity among physicians, increased oncology teaching, and preservation of resident autonomy; PDSA 2 identified need for increased nursing-physician collaboration. Conclusions: Hospitalist comanagement can effectively reduce oncology LOS without adverse effect on readmission rates, educational outcomes, or oncologist satisfaction with care.[Table: see text]

Evidence-based health interventions for the educational sector: Application and lessons learned from developing European food hygiene and safety teaching resources

BackgroundFoodborne illnesses have a significant global burden and can be life-threatening, but good food hygiene practice can prevent most. SafeConsume is an EU-funded, transdisciplinary project aiming to improve consumers’ food safety behaviour and reduce the burden of foodborne illness. Young people are at risk of foodborne illness and research indicates a lack of knowledge or concern about food hygiene. Educational settings provide an opportunity to influence behaviour; but for resources to be effective and implementable, they should be evidence-based and thoughtfully designed. AimTo develop educational resources to teach food hygiene and food safety to school children aged 11–18 years old, through a user-based approach, specific to the educational setting. MethodsDevelopment used a two-step process referred to as: the insight phase; and prototyping and refinement phase. This included using the findings of a needs assessment with students and educators based on the Theoretical Domains Framework (TDF) presented in earlier publications (Eley et al., 2021; Syeda et al., 2021). A user-centred approach to development was then taken, employing an iterative process of idea generation, consultation with a multidisciplinary steering group, and user testing. ResultsThe insight phase identified students' and educators’ deficiencies in knowledge and skills, and cultural and social influences on food safety behaviours. This phase, including Curriculum analysis informed student learning objectives and educator training topics. Following a round of development and consultation, a total of seven teaching resources were developed, with four educator training modules to improve knowledge and confidence of educators. ConclusionsBehavioural theory is a useful foundation for the development of school-based health interventions, which aim to positively influence students' knowledge, behaviour, and attitudes. To support educators’ uptake, materials should be aligned to the national curriculum and should consider practical factors like time and environmental factors. By working closely with stakeholders at all stages of development, barriers to use, implementation and efficacy can be identified and mitigated.

Development of an online patient decision aid for kidney failure treatment modality decisions

BackgroundPatient decision aids (PtDAs) support patients and clinicians in shared decision-making (SDM). Real-world outcome information may improve patients’ risk perception, and help patients make decisions congruent with their expectations and values. Our aim was to develop an online PtDA to support kidney failure treatment modality decision-making, that: 1) provides patients with real-world outcome information, and 2) facilitates SDM in clinical practice.MethodsThe International Patient Decision Aids Standards (IPDAS) development process model was complemented with a user-centred and convergent mixed-methods approach. Rapid prototyping was used to develop the PtDA with a multidisciplinary steering group in an iterative process of co-creation. The results of an exploratory evidence review and a needs-assessment among patients, caregivers, and clinicians were used to develop the PtDA. Seven Dutch teaching hospitals and two national Dutch outcome registries provided real-world data on selected outcomes for all kidney failure treatment modalities. Alpha and beta testing were performed to assess the prototype and finalise development. An implementation strategy was developed to guide implementation of the PtDA in clinical practice.ResultsThe ‘Kidney Failure Decision Aid’ consists of three components designed to help patients and clinicians engage in SDM: 1) a paper hand-out sheet, 2) an interactive website, and 3) a personal summary sheet. A ‘patients-like-me’ infographic was developed to visualise survival probabilities for each treatment modality on the website. Other treatment outcomes were incorporated as event rates (e.g. hospitalisation rates) or explained in text (e.g. the flexibility of each treatment modality). No major revisions were needed after alpha and beta testing. During beta testing, some patients ignored the survival probabilities because they considered these too confronting. Nonetheless, patients agreed that every patient has the right to choose whether they want to view this information. Patients and clinicians believed that the PtDA would help patients make informed decisions, and that it would support values- and preferences-based decision-making. Implementation of the PtDA has started in October 2020.ConclusionsThe ‘Kidney Failure Decision Aid’ was designed to facilitate SDM in clinical practice and contains real-world outcome information on all kidney failure treatment modalities. It is currently being investigated for its effects on SDM in a clinical trial.

Development of a web-based, patient-centered decision aid for oropharyngeal cancer treatment

ObjectivesMany patients diagnosed with oropharyngeal squamous cell carcinoma (OPSCC) have the option of radiation- or surgery-based therapy, and would benefit from a treatment decision aid (DA) to make decisions congruent with their personal values. Our objective was to develop a patient-centered DA for patients with OPSCC that is comprehensible, usable, acceptable, and well-designed. Materials and MethodsDecisional needs from a pilot study of OPSCC survivors and treating physicians were used to inform a web-based prototype DA. A multidisciplinary steering group developed and iteratively revised the DA. Feasibility testing was conducted in two cycles to assess perspectives of stakeholders (medical, radiation and surgical oncologists, patient education experts, and OPSCC survivors). Survey data and open-ended responses were used to evaluate and refine the DA. Results16 physicians, 4 patient education experts, and 6 survivors of OPSCC evaluated a web-based DA prototype in two cycles of testing. Participant feedback was used to revise the DA content and design between cycles. The majority of participants across both cycles indicated that the DA was comprehensible (97%), usable (86%), acceptable (78%), and well-designed (93%). Approximately three quarters of respondents indicated that they would use or share the DA in clinical practice. ConclusionWe developed the first patient-centered treatment decision aid (DA) designed for patients with OPSCC, to our knowledge. The DA was perceived favorably by stakeholders, with more than three quarters of respondents indicating they would use it in clinical practice. This tool may improve clinical practice as an adjunct to shared decision-making for OPSCC.

The role of HTA in COVID-19 vaccination campaign: the Italian experience

Issue/problemItaly was one of the four European countries that started to join forces to accelerate access and distribution of a much-needed vaccine against COVID-19. When the first vaccine was approved, a National Strategic Plan for COVID-19 vaccination, examining the most relevant domains for Health Technology Assessment (HTA), has just been issued in Italy.Description of the problemConsidering the possible provision of COVID-19 vaccines in the short time, in Autumn 2020 the necessity for a comprehensive assessment came up. In Italy HTA has been identified as the method for assessing the broad value of existing and new vaccines by the last two National Immunization Plans. However, the pandemic highlighted the need for a quick introduction and distribution of COVID-19 vaccines. A multidisciplinary Steering Group was therefore appointed by the Ministry of Health, in order to define vaccination strategies, organizational models, economic aspects, communication and social issues.ResultsTaking into account plans already released by other countries, a National Strategic Plan for COVID-19 vaccination was issued in December 2020. Main topics covered were: epidemiology and priority groups to be immunized, logistic and organization, efficacy and safety monitoring, economic and burden of disease assessments, communication. The application of these recommendations has finally proven to be difficult, because of vaccines procurement delays, suspected adverse events, inequalities in the different Regional settings.LessonsGiven the concerns and difficulties faced by Italy and other European countries in the appraisal and management of COVID-19 vaccines, a HTA adapted framework could be an option for guiding the definition of National Strategic Plans. This could offer a common structured approach, make decision-making process more transparent, and be significant for a timely, convenient, and affordable access to new vaccines against SARS-CoV-2.

A Clinical Practice Guideline Summary for Pharmacological Management of Adults with Major Depressive Disorder in Malaysia

Background: Clinical Practice Guidelines (CPGs) are systematically developed statements to assist practitioners and patients with appropriate health care for specific clinical circumstances. However, evidence suggests that the uptake of these recommendations in routine care is still limited, particularly in resource-constrained countries.
 Objectives: This article aimed to (1) identify current CPGs for the pharmacological management of MDD that address and are compatible with the needs of Malaysian psychiatrists (2) collate and summarise these CPG recommendations to produce a more culturally sensitive and end-user friendly guideline summary.
 Materials and Methods: A multidisciplinary steering group followed an adapted development approach that included; (1) searching for guidelines on the pharmacological management of adults with depression, (2) screening them for relevant recommendations, (3) critical appraising these guidelines, and (4) extracting the required information. A panel of experts then reviewed the developed guideline summary.
 Results: Six potentially relevant guidelines for the pharmacological management of depression in adults were identified. The developed summary included a decision algorithm to guide the selection of antidepressant therapy based on clinical factors, potential drug-drug interaction, tolerability, and cost of the medications. The review panel considered the summary recommendations easy to use and had the potential for uptake by busy psychiatrists.
 Conclusion: A CPG summary for the pharmacological management of depression was developed that focuses on evidence-based, contextually relevant recommendations that are feasible for implementation within the local healthcare settings in Malaysia.
 Practical Implications: The developed guideline summary has the potential to enhance the implementation of evidence-based practice in the management of Major Depressive Disorder within the Malaysian context.

Primary prevention of ovarian cancer: a patient decision aid for opportunistic salpingectomy

The discovery of the fallopian tube epithelium as the origin of high-grade serous ovarian cancer has brought a new option for ovarian cancer prevention. The fallopian tubes have no known function after completion of childbearing and can be removed to reduce the lifetime risk of ovarian cancer. Although the lifetime risk in the general population does not justify preventive surgery in itself, salpingectomy can be performed during abdominal surgery for other indications, also known as an opportunistic salpingectomy. The popularity of opportunistic salpingectomy is increasing worldwide; however, the variation between gynecologists and hospitals in their advice on opportunistic salpingectomy occurs because of the remaining uncertainty of evidence. Therefore, whether a woman can make her own decision depends on the hospital or gynecologist she visits. We aimed to lower this practice variation by providing standardized and unbiased counseling material. We aimed to develop and test a patient decision aid for opportunistic salpingectomy in women undergoing pelvic gynecologic surgery to either retain the ovaries or opt for sterilization. We followed a systematic development process based on the International Patient Decision Aid Standards. Data were collected between June 2019 and June 2020, using both qualitative and quantitative methods. The development process that occurred in collaboration with patients and healthcare professionals was overseen by a multidisciplinary steering group and was divided into 4 phases: (1) assessment of decisional needs using individual telephone interviews and questionnaires; (2) development of content and format based on decisional needs, current literature, and guidelines; (3) alpha testing and the first revision round; and (4) alpha testing and the second revision round. An outline of the patient decision aid was developed on the basis of decisional needs, current literature, and guidelines. It became clear that the decision aid should consist of 2 separate paths: one with information specifically for salpingectomy in addition to abdominal surgery and one for salpingectomy as a sterilization method. Both paths contained information on the anatomy and function of ovaries and fallopian tubes, risk reduction of ovarian cancer, and potential benefits and risks of opportunistic salpingectomy. Moreover, the sterilization path contains information on various sterilization methods and risks of unwanted pregnancy. The patient decision aid was developed as an online tool that includes information chapters, a knowledge quiz, consideration statements, and a summary detailing the patient's preferences and considerations. Adjustments were made following alpha testing round 1. The improved patient decision aid was subjected to usability tests (alpha testing round 2), in which it scored an "excellent" in tests with patients and a "good" in tests with gynecologists. Furthermore, our patient decision aid met the requirements of 45 of 49 applicable items from the International Patient Decision Aid Standards criteria. In collaboration with patients and healthcare professionals, a patient decision aid was developed on opportunistic salpingectomy and salpingectomy as a sterilization method. Both patients and gynecologists believed it is a useful tool that supports patients in making an informed decision whether to undergo an opportunistic salpingectomy and supports the counseling process by gynecologists.

Development of a patient decision aid on subacromial decompression surgery and rotator cuff repair surgery: an international mixed-methods study

ObjectiveTo develop and user test a patient decision aid for people with subacromial pain syndrome that presents evidence-based information on the benefits and harms of subacromial decompression surgery and rotator...

Development and field testing of a patient decision aid for management of acute Achilles tendon rupture: a study protocol

BackgroundAchilles tendon ruptures are common injuries in an otherwise healthy, active population. Several treatment options exist, with both surgical and non-surgical options. Each treatment option has a unique set of risks and harms, which may present patients with decisional conflict. The aim of the proposed study is to develop, alpha test and field test a patient decision aid for patients presenting with acute Achilles tendon ruptures.MethodsThis is a three-stage study protocol. First, we will assemble a multi-disciplinary steering group including patients, clinicians, educators, and researchers to develop the patient decision aid prototype using the Ottawa Decision Support Framework. Second, we will perform a mixed-methods alpha test of the decision aid prototype with patients and clinicians experienced in acute Achilles tendon ruptures. Outcomes measured will include acceptability and usability of the patient decision aid measured using validated outcome scales and semi-structured interviews. A minimum of three rounds of feedback will be obtained. Results will be analyzed using descriptive statistics, reviewed by the steering group, to guide revisions to decision aid prototype at each round. The third stage will be field testing the revised decision aid prototype in usual clinical care. A pre-/post-study will be performed with patients with acute Achilles tendon ruptures. Patients will be recruited from the emergency department and complete the pre-consultation decision aid prior to a one-week follow up with their surgeon. The primary outcome of field testing will be feasibility of implementing the decision aid in the clinical setting and will be measured with recruitment and completion metrics. Secondary outcomes include acceptability of the decision aid, knowledge, preparedness for decision making, and decisional conflict, measured using validated outcome measures. Statistical analysis will be performed using descriptive analysis for primary outcomes and a student t-test and Wilcoxon Rank-Sum test for secondary outcomes.DiscussionThis comprehensive study protocol outlines the development, alpha testing, and field testing of a patient decision aid for patients with acute Achilles tendon rupture. Systematic and transparent development and testing of patient decision aids is critical to improve decision aid quality.Trial registration Not Applicable.

Core Outcome Measures for Palliative and End-of-Life Research After Severe Stroke: Mixed-Method Delphi Study.

Stroke is the second commonest cause of death worldwide and a leading cause of severe disability, yet there are no published trials of palliative care in stroke. To design and evaluate palliative care interventions for people with stroke, researchers need to know what measurable outcomes matter most to patients and families, stroke professionals, and other service providers. A multidisciplinary steering group of professionals and laypeople managed the study. We synthesized recommendations from respected United Kingdom and international consensus documents to generate a list of outcome domains and then performed a rapid scoping literature review to identify potential outcome measures for use in future trials of palliative care after stroke. We then completed a 3-round, online Delphi survey of professionals, and service users to build consensus about outcome domains and outcome measures. Finally, we held a stakeholder workshop to review and finalize this consensus. We generated a list of 36 different outcome domains from 4 key policy documents. The rapid scoping review identified 43 potential outcome measures that were used to create a shortlist of 16 measures. The 36 outcome domains and 16 measures were presented to a Delphi panel of diverse healthcare professionals and lay service users. Of 48 panelists invited to take part, 28 completed all 3 rounds. Shared decision-making and quality of life were selected as the most important outcome domains for future trials of palliative care in stroke. Additional comments highlighted the need for outcomes to be feasible, measurable, and relevant beyond the initial, acute phase of stroke. The stakeholder workshop endorsed these results. Future trials of palliative care after stroke should include pragmatic outcome measures, applicable to the evolving patient and family experiences after stroke and be inclusive of shared decision-making and quality of life.

MO1036DEVELOPMENT OF A DIGITAL SELF-MANAGEMENT EDUCATION PROGRAMME TO IMPROVE HEALTH BEHAVIOURS IN PEOPLE WITH NON-DIALYSIS CKD

Background and AimsAppropriate disease and healthcare management are key behaviours for health optimisation in people with long-term conditions including CKD. Effective self-management of health requires appropriate knowledge, skills and confidence. Digital health interventions are potentially appealing tools to improve knowledge and self-management behaviours, as well as actively involving individuals in their healthcare, particularly in the post-COVID-19 era. However, the development strategies and processes behind such interventions are poorly defined. Here we describe the systematic development of a digital self-management programme for people living with non-dialysis CKD which includes novel approaches to improving self-management and health behaviours.MethodIntervention mapping (IM) was used to guide the development of a digital self-management programme called ‘My Kidneys and Me’ (MK&M) to ensure that it can be implemented in clinical practice. The development process was guided by the first four steps of IM: (1) establish multidisciplinary and patient and public involvement (PPI) steering groups to describe the context of the intervention and programme goals; (2) identify objectives and determinants at early design stages to maintain a focus on the strategies adopted; (3) generate the programme components underpinned by appropriate psychological theories and models; (4) develop the programme content and describe the iterative process of refining the content and format of the digital programme for evaluation and implementation. The last two steps (adoption, implementation, and evaluation plan) will be evaluated alongside a forthcoming trial.ResultsA multidisciplinary steering group was formed consisting of 23 healthcare professionals, researchers, and digital health experts who provided expertise in the clinical and psychosocial aspects of CKD, self-management, digital health, and behaviour change research. A PPI steering group of 12 patients and family members identified the needs and priorities of MK&M, providing feedback at relevant time points.As a result of previous literature and input from both steering groups, MK&M was developed with the aim to improve and maintain self-management behaviours, including to improve knowledge, promote self-care skill, increase self-efficacy, improve well-being, and increase physical activity. These target behaviours were translated into key programme goals: 1) increase patient activation; 2) reduce health risks; 3) manage symptoms; and 4) increase physical function.Based on patient input and needs, MK&M was designed to comprise educational (Learn about …) and behaviour change (How to …) sessions, health trackers (e.g. blood pressure, weight, fruit and veg consumption), symptom tracker, exercise trackers, goal setting features, and social support. For example, to improve symptom management behaviours, patients can use MK&M to: 1) learn about symptoms associated with CKD and strategies to help manage these symptoms; 2) learn how to recognise and keep track of their symptoms so that they can modify their lifestyle accordingly and speak to their healthcare professional if needed; 3) track their symptoms using a bespoke tool.ConclusionApplying the IM framework enabled us to systematically use theory, empirical evidence, and practical perspectives in the development of MK&M. Our evidence- and theory-based online self-management programme provides ongoing support and guidance to people with CKD. The efficacy of MK&M to improve patient self-management behaviour is being studied in a multi-site RCT in the UK.MO1036 Figure 1: My Kidneys & Me login page and home page

Development and testing of a tailored online fertility preservation decision aid for female cancer patients.

BackgroundDecision making regarding future fertility can be very difficult for female cancer patients. To support patients in decision making, fertility preservation decision aids (DAs) are being developed. However, to make a well‐informed decision, patients need personalized information tailored to their cancer type and treatment. Tailored cancer‐specific DAs are not available yet.MethodsOur DA was systematically developed by a multidisciplinary steering group (n = 21) in an iterative process of draft development, three rounds of alpha testing, and revisions. The drafts were based on current guidelines, literature, and patients' and professionals' needs.ResultsIn total, 24 cancer‐specific DAs were developed. In alpha testing, cancer survivors and professionals considered the DA very helpful in decision making, and scored an 8.5 (scale 1–10). In particular, the cancer‐specific information and the tool for recognizing personal values were of great value. Revisions were made to increase readability, personalization, usability, and be more careful in giving any false hope.ConclusionsA fertility preservation DA containing cancer‐specific information is important in the daily care of female cancer patients and should be broadly available. Our final Dutch version is highly appraised, valid, and usable in decision making. After evaluating its effectiveness with newly diagnosed patients, the DA can be translated and adjusted according to (inter)national guidelines.