Impact of an in-consult patient decision aid on decisional quality, involvement, and health outcome for patients with severe hip or knee osteoarthritis – a study protocol for a multicentre, cluster randomised controlled trial (PATI-study)

Impact of an in-consult patient decision aid on decisional quality, involvement, and health outcome for patients with severe hip or knee osteoarthritis – a study protocol for a multicentre, cluster randomised controlled trial (PATI-study) | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol Impact of an in-consult patient decision aid on decisional quality, involvement, and health outcome for patients with severe hip or knee osteoarthritis – a study protocol for a multicentre, cluster randomised controlled trial (PATI-study) Trine Ahlmann Pedersen, Martin Lindberg-Larsen, Charlotte Myhre Jensen, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4354090/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 02 Jul, 2025 Read the published version in BMC Musculoskeletal Disorders → Version 1 posted 9 You are reading this latest preprint version Abstract Background: Osteoarthritis (OA) of the hip or knee is a widespread joint disease, often leading to replacement surgery. However, despite the high success rate of replacement surgery, some patients fail to experience the intended benefits. Given the importance of patient involvement, this trial aims to assess the effect of shared decision-making (SDM) on decisional quality for patients with severe OA. Specifically, it investigates whether an in-consult patient decision aid (PtDA) enhances decisional quality, involvement, and health outcomes for patients with severe hip or knee OA. Methods: This protocol outlines a pragmatic two-armed multicentre cluster-randomised controlled trial (C-RCT) involving 19 orthopaedic surgeons randomised 1:1, stratified by centre, to either continue standard consultations or SDM with a newly developed in-consult PtDA. This trial intends to recruit 615 patients diagnosed with severe OA in their hip or knee. Surveys measuring decisional quality and disease-specific and generic health outcomes will be sent out at multiple time points: one-week post-consultation and three and 12 months post-consultation or post-surgery. The primary outcome (decisional quality) will be measured using the Hip/Knee OA Decision Quality Instrument and assessed based on the percentage of patients who are well-informed and receive their preferred treatment. The secondary outcomes include patient involvement in the decision-making process and consultation durations. The tertiary outcomes include patients’ satisfaction, regret and health-related outcomes. Discussion: This study aims to contribute insights into the use of SDM facilitated by a PtDA and its impact on improving decisional quality for future patients with hip or knee OA. Trial registration: www.ClinicalTrials.gov (NCT05972525), Data of registration: 06.08.2023 Osteoarthritis total hip replacement total knee replacement unicompartmental knee replacement shared decision-making decisional quality patient-reported outcome cluster-randomised trial Figures Figure 1 Figure 2 Figure 3 Background Osteoarthritis (OA) is one of the most prevalent joint diseases, affecting approximately 600 million individuals worldwide [1]. The prevalence of OA is anticipated to increase due to gradually increasing obesity and age in the population with high physical activity [1–4]. OA typically affects the hip or knee and induces pain and disability, leading to reduced function and quality of life (QoL), particularly in older adults [5, 6]. Severe cases often need hip or knee replacement [7–9]. These surgeries are among the most frequently performed procedures worldwide [2, 9], with proven success in terms of pain relief, increased function and enhanced health-related QoL [10, 11]. While recommendations for treating early-stage OA are generally consistent [7], the decision to proceed with total joint replacement (TJR) in severe cases is influenced by patient and clinician preferences, considering factors such as symptom severity, radiological findings, age, comorbidities and QoL [4, 12]. Despite its benefits, some patients undergoing TJR fail to experience the intended results [3, 13]. Dissatisfaction rates after total hip replacement (THR), total knee replacement (TKR) and unicompartmental knee replacement (UKR) have been reported as 7%, 11–18% and 10%, respectively [14–17]. Studies have identified a clear association between postoperative dissatisfaction and the misalignment of preoperative expectations with actual outcomes [16, 18, 19], while patients whose expectations are met express higher satisfaction with their surgical outcomes [16, 20]. However, it is important to acknowledge that patient preferences can sometimes be influenced by expectations that do not align with the expected outcomes from TJR surgery. A considerable number of patients choose a surgical intervention to manage joint pain without a comprehensive understanding of what to expect from either surgery or alternative treatment options [21–23]. Engaging patients in shared decision-making (SDM) is recognised as a crucial strategy to enhance decisional quality, especially in preference-sensitive decisions such as to undergo TJR [24, 25]. SDM can be facilitated by patient decision aids (PtDAs), which serve to inform patients about relevant treatment options and promote the SDM process. Despite over 209 randomised trials on using PtDAs in usual care [26], only a few have examined their impact among patients with OA of the hip or knee [27–29]. This PATient Involvement (PATI) study aims to investigate how SDM and using an in-consult PtDA affect decisional quality, patient involvement and health outcomes for patients with severe hip or knee OA referred for treatment. Methods/design This study adheres to the Standard Protocol Items for Randomized Trials (SPIRIT) guidelines [30] and follows the recommendations of the Standards for Universal Reporting of Decision Aids Evaluation (SUNDAE) [31]. It is reported according to the Consolidated Standards of Reporting Trials (CONSORT) extended guidelines for cluster-randomised controlled trials (C-RCTs) [32]. Study design This study was a two-armed, multicentre (two centres), pragmatic superiority [33], C-RCT. Each cluster consisted of one single hip or knee surgeon randomised (allocated 1:1) to either continue standard consultation or perform SDM with an in-consult PtDA developed explicitly for patients with hip or knee OA before this study. Nineteen clusters across two university hospitals in Denmark were randomised and stratified by centre. The scheduled consultation duration remained consistent, regardless of the intervention or control group. The primary and secondary outcomes based on patient-reported data are collected one week post-consultation (timepoint 1 [T1]), and a project nurse registered the patients’ received or scheduled treatment six months post-consultation. The tertiary outcomes are assessed three months (timepoint 2 [T2]) and 12 months after treatment begins (timepoint 3 [T3]) and will be reported in follow-up studies. Specific objectives and hypotheses Objective 1: To investigate whether using an in-consult PtDA enhances the decisional quality for patients with severe OA of the hip or knee referred for treatment. Hypothesis 1 Patients receiving consultations using an in-consult PtDA will achieve higher decisional quality than those receiving standard consultations. Objective 2: To investigate whether an in-consult PtDA increases patient-experienced involvement in SDM. Hypothesis 2 Patients receiving consultations using an in-consult PtDA will report greater involvement in SDM than those who receive standard consultations. Objective 3: To compare durations between consultations using SDM with an in-consult PtDA and standard consultations and explore the learning curve in using the in-consult PtDA, expressed as the consultation duration. Hypothesis 3.1 The duration will not differ between consultations using the in-consult PtDA and standard consultations. Hypothesis 3.2 The duration of consultations using the in-consult PtDA will decrease over time, indicating a learning curve associated with PtDA integration. Objective 4: To determine whether consultations using the in-consult PtDA are superior to standard consultations regarding the level of changes in the patient-reported outcomes of pain, physical function and QoL at 3 and 12 months following surgery. Hypothesis 4 Consultations using a PtDA are superior to standard consultations regarding the level of changes in the patient-reported outcomes of pain, physical function and QoL at 3 and 12 months after surgery. Objective 5: To determine the association between informed patient-centred (IPC) decisions and the level of changes in the patient-reported outcomes of pain, physical function and QoL at 3 and 12 months after surgery. Hypothesis 5 IPC decisions are positively associated with the level of changes in patient-reported outcomes related to pain, physical function and QoL at 3 and 12 months after surgery. Objective 6: To evaluate whether consultations using a PtDA are superior to standard consultations regarding patient satisfaction at 3 and 12 months after surgery. Hypothesis 6 Consultations using a PtDA are superior to standard consultations regarding patient satisfaction at 3 and 12 months after surgery. Participants, interventions and outcomes Participants Patients with OA in their hip or knee referred from general practice and scheduled for consultations with orthopaedic surgeons across the two study centres are screened for eligibility by the surgeons during the consultations regardless of the intervention arm. The surgeons inform the patients about the trial concept using a standardised protocol and obtain verbal informed consent. The inclusion criteria for patients are: Diagnosed with severe primary OA eligible for primary THR, TKR or UKR Aged ≥ 18 years Able to understand and read Danish Provide informed consent Able to receive mail in the electronic digital mailbox (E-Boks) Patients with the following will be excluded: Previous THR, TKR or UKR Cognitive impairment Non-OA-related diagnoses Interventions Two new in-consult PtDAs for patients with severe OA in the hip or knee were developed from a generic PtDA template adhering to the criteria set by the International Patient Decision Aid Standards [34, 35] to be tested in the intervention group. Both PtDAs, entitled ‘Which Treatment Is Right for Me?’ (Fig. 1 ), are presented in booklet form and represent the first editions of such aids for hip and knee OA in Denmark. Structured into five sections following the framework outlined by Steffensen et al. [36], these PtDAs feature option cards illustrating the pros and cons of each treatment, simplified statistics and patient stories. Surgeons in the intervention group received a three-hour introduction and training course on the SDM concept and using an in-consult PtDA the day before the trial commenced at each of the two centres. This introduction also provided information about screening, recruitment, intervention and survey delivery at specific time points. Surgeons in the control group participated in a mandatory introductory course covering trial design with detailed task discussions. The sequence of activities within the orthopaedic clinic flow is illustrated in Fig. 2 . Outcomes Demographics (T1) include participants’ age, sex, education level, income status, PtDA handout (yes or no) and a single-item self-reported pain score on a five-point Likert scale. At the cluster level, the information includes surgical experience (years), surgeon’s age, sex and surgical joint speciality (hip or knee; Table 1 ). Table 1 Data collection, consent and timing of the questionnaires. Outcome Domain Measurement instruments Objectives Consultation (T1) (T2) Six months post-consultation (T3) Score range Items: N (range) Patient informed consent Informed consent x x Demographics Demographic questionnaire X - IPC decision Concordance and Knowledge scores (HK-DQI) [37] 1, 6 X Cat (yes [0]/no [1]) Concordance score Knowledge sum score (0–1) Knowledge score Knowledge score (HK-DQI) [37] 1 X Con (0–100) Five items (0–5) Treatment received Patient journal 1 X Cat (non-surgical [0]/surgical [1]) One item (0–1) Patient involvement Decisional process score (HK-DQI) [37] 2 X Con (0–100) Five items (0–4) Patient-reported engagement CollaboRATE [47] 2 X Con (0–100) Three items (0–9) Time duration Self-documented 3 X Con (minutes) - Quality of life EQ-5D-5L [41] 4, 6 X X X Con (− 0.757–1.000) Five items (1–5) Physical function OHS [43] 4, 6 X X X Con (0–48) 12 items (0–4) Physical function OKS [42] 4, 6 X X X Con (0–48) 12 items (0–4) Physical function FJS [48] 4, 6 X X X Con (0–100) 12 items (1–5) Patient satisfaction One question on satisfaction with received treatment 5 X X Cat (yes/no) One item (0–1) Decision regret Decision regret scale [45] 5 X X Con (0–100) Five items (0–4) Timepoints of data collection, send out through REDCap. Data types include Cat (categorical) and Con (continuous) variables, collected at T1 (one week post-visit), T2 (three months post-treatment), and T3 (12 months post-treatment). Primary outcome: The primary outcome is the Hip/Knee OA Decision Quality Instrument (HK-DQI; T1), a patient-centred questionnaire designed to evaluate the quality of decision-making for joint replacement decisions. The HK-DQI is based on the Decision Quality Instrument (DQI), a disease-specific tool developed in the US in 2010 [37] that has separate versions tailored for hip (DQI-Hip) and knee (DQI-Knee) OA. These versions share identical content but differ in joint-specific terminology, collectively forming the HK-DQI [38]. The HK-DQI consists of three sections that assess decision-specific goals and concerns, decision-specific knowledge and the decision-making process [37]. It has demonstrated strong psychometric properties, including test-retest reliability, validity, sensitivity, acceptability and feasibility [37, 39]. Recently, both HK-DQI versions have been translated into Danish, and their psychometric properties have been rigorously evaluated. The IPC decision (T1) is calculated as the percentage of patients who are well-informed (answering at least three out of five knowledge questions correctly) and concordance between preferred and received treatment (surgical or non-surgical). Secondary outcomes: CollaboRATE (T1) is a three-item patient-reported outcome measure assessing the level of SDM in the clinical encounter, evaluating healthcare quality and provider performance on a scale from 0 (no effort) to 9 (maximum effort) [40]. The surgeon learning curve (T1) is measured by surgeons after each consultation throughout the trial period, documenting their duration. Tertiary outcomes: EuroQol five-dimension five-level questionnaire (EQ-5D-5L; T1, T2 and T3) is a generic, concise, five-item preference-based health status measurement. It generates a single index value for health status ranging from − 0.757 to 1.000, with 1 indicating full health, 0 indicating death and a value below 0 indicating a health state worse than death [41]. Oxford Hip Score (OHS) and Oxford Knee Score (OKS; T1, T2 and T3) are both 12-item questionnaires with a score from 0 (worst) to 48 (best) points. They assess joint-specific outcomes and are widely used in research related to THR and TKR/UKR. Recognised for their reproducibility, validity and sensitivity to clinically meaningful changes, the OHS and OKS are tools for evaluating hip and knee function [42, 43]. Forgotten Joint Score (FJS; T1, T2 and T3) is a 12-item questionnaire assessing participants’ awareness of their artificial joints during activities of daily living (ADL) with a score ranging on a scale from 0 to 100 with higher values indicating that the patients successfully ‘forgetting’ the joint replacement during ADL. The FJS is used to assess the level of patient satisfaction after joint replacements, particularly in the hip and knee [44]. The decision regret scale (T2 and T3) is a five-item questionnaire used to assess the extent of regret or dissatisfaction individuals may experience regarding a specific decision, such as a healthcare choice or treatment option. The sum scores are scaled from 0 to 100, where 0 signifies no regret [45, 46]. Satisfaction (T2 and T3) comprises one question with response possibilities on a seven-point Likert scale assessing the patient’s overall satisfaction with health-related outcomes after treatment. The sum scores are scaled from 0 to 100, where 0 indicates high satisfaction. Delivery of interventions and assessments Patients with severe OA of the hip or knee referred from general practice and scheduled for appointments with orthopaedic surgeons at the two centres were screened for eligibility by the surgeon at the end of their consultation, irrespective of the intervention arm. Intervention consultation : Patients in the intervention group consulting a surgeon actively participate in the decision-making process through SDM facilitated by an in-consult PtDA in addition to standard preliminary examinations. Standard consultation : Patients in the control group undergo standard preliminary examinations with a surgeon and receive information following the usual practices at each centre. Enrolment : Surgeons in both groups screen, recruit, obtain informed consent and provide written information to eligible patients at the end of the consultation. Eligible patients are enrolled regardless of the chosen treatment option. For patients undergoing non-surgical treatment, the treatment begins on the enrolment date, while for surgical patients, it begins on the date of surgery. Local project nurses ensure the recording of all screened patients in the electronic Research Electronic Data Capture (REDCap) database. First survey at T1 : One week after visiting the orthopaedic outpatient clinic, enrolled patients receive the (T1) survey in their electronic digital mailbox. Second survey at T2 : Follow-up assessments (T2) are collected through the patient’s electronic digital mailbox three months after receiving surgical or non-surgical treatment. Treatment received or scheduled is registered by project nurses six months after consultation through a review of the patients’ electronic medical files. Third survey at T3 : The final follow-up assessments (T4) are sent via the patient’s electronic digital mailbox 12 months after their treatment began. Enrolment and trial dates Setting and enrolment strategies The study recruited patients and surgeons from the orthopaedic departments specialising in fast-track hip and knee replacement at two university hospitals in the Region of Southern Denmark. These departments collectively perform almost 2,700 out of the approximately 26,000 THR, TKR and UKR surgeries performed annually in Denmark. An inclusion period of 12 months was expected, with an inclusion rate of 23% involving weekly enrolment of 11 patients and an anticipated dropout rate of 20%. The inclusion flow is illustrated as a CONSORT flow diagram (Fig. 3 ) [32]. Trial dates Patient enrolment began in October 2023 at the first centre and in November 2023 at the second centre. The 12-month follow-up period commenced after patients received surgical or non-surgical treatment. Due to current waiting lists, the data collection period was estimated to last approximately two years, with an anticipated completion during the summer of 2026. Randomisation and blinding In October 2022, orthopaedic surgeons specialised in hip or knee replacements from both centres were randomised for the PATI study. Before the start of the trial, surgeons in the intervention group participated in the development phase of two new in-consult PtDAs (Fig. 2 ) that will be used in the intervention arm. A 1:1 randomisation was implemented using a computer-generated randomisation schedule, stratified by the surgeons’ employment centres and using permuted blocks of size 10. Additional blocks, each with a size of two, were introduced to accommodate potential changes, such as surgeons leaving or newly hired to the departments during the trial period. An independent data manager created the computer-generated list of random numbers using the randomisation tool in REDCap [49]. The administrator responsible for the PATI study and the randomisation procedure will remain blinded to the sequence of random numbers within the blocks throughout the trial period. The randomisation of the clusters was disclosed to the two centres before the start of the trial. Patients will not be blinded to the interventions but will not be provided with explicit information about the intervention or control assignments. Similarly, the surgeons, project managers, and project nurses involved in the trial will not be blinded. Data collection, sample size and analyses Data collection Upon their enrolment, patients’ assessments will be sent through REDCap. They will directly enter all data related to patient-reported outcomes into REDCap, with the ‘required fields’ option activated to ensure no missing items from completed questionnaires. Patients who fail to respond will receive reminders after three and six days. In case of continued non-response, the local project nurse will be notified and initiate up to two phone calls. If no response is obtained, the patients will be marked as ‘lost to follow-up’ in the database for the specific time point. Sample size The required sample size was estimated considering the possibility of some surgeons leaving the two centres during the trial period. Therefore, the sample size was calculated based on 15 clusters (surgeons) with an assumed intraclass correlation coefficient of 0.02, which represents how strongly individuals within clusters are related [50]. We also assumed a superiority difference between groups of 15% based on data from a comparable US setting, indicating that 40% of patients in the intervention group have high decisional quality compared to 25% in the control group [37, 38]. A total sample size of 615 patients will be enrolled to achieve a statistical power of 80% at a two-sided significance level of 0.05, which corresponds to approximately 41 patients in each cluster, accounting for an expected 20% loss to follow-up. Statistical analysis plan The statistics will be reported according to the guidelines outlined by the Enhancing the Quality and Transparency of Health Research (EQUATOR) network [51] and CONSORT [32] statements. A detailed statistical analysis plan was developed with the study protocol to ensure transparent and reproducible statistical methods. The primary and secondary outcomes will be statistically analysed using mixed-effect models based on linear or binomial regression according to the data type of interest [52]. Due to the hierarchical structure of the data, surgeons will be incorporated as random effects. The analysis will be performed using the intention-to-treat approach, and in case of a cross-over, a per-protocol analysis will be conducted as sensitivity analysis [52]. Given the common presence of ceiling effects in several SDM assessment scores [53, 54], a sensitivity analysis will be conducted using a mixed-effect Tobit regression model [55] to explore their potential influences. Consultation time will be analysed using a t -test if normally distributed and a Wilcoxon rank sum test otherwise. Histograms will be visually inspected to assess the normality assumption. The learning curve will be explored through descriptive analysis. The proportion of missing data will be explored. If less than 5% of the data is missing, a complete case analysis will be performed. If more than 5% of the data is missing, the missing data structures will be investigated, considering potential imputation methods [52, 56]. Data monitoring and auditing Given this study’s minimal risk, an external Data and Safety Monitoring Board was not established. Instead, the study manager and local project nurses are conducting meticulous internal data monitoring. The study manager and project nurses hold weekly meetings, either in person or by phone, to ensure adherence to the protocol and the smooth progression of the project. All aspects of participant enrolment, including recruitment and survey response rates across the two centres, are being systematically tracked. No interim analyses are planned for this study. Ethics and dissemination Protocol amendments Any substantial adjustments to the protocol will be appropriately registered at www.ClinicalTrials.gov , reported to The Regional Committees on Health Research Ethics for Southern Denmark and addressed in the primary C-RCT publication. Patient and public involvement Before initiating the PATI study, a qualitative study contributed to developing two distinct in-consult PtDAs tailored to patients with hip and knee OA entitled “Which Treatment Is Right for Me?” Surgeons randomised to the intervention group and fifteen patients actively participated in focus group discussions and remained engaged throughout the development and testing processes. Study participant consent Before the C-RCT began, a comprehensive kickoff meeting was conducted to engage all study staff from each centre. In this meeting, participants were briefed about its objectives, their respective roles and the anticipated timeline for enrolment. This meeting was held to foster an open communication environment, encouraging study staff and surgeons to contribute with suggestions or raise any concerns related to the trial material and setup. Patient consent Eligible patients are presented with verbal and written information about the study, including the privacy protection concept according to ethical standards outlined in the Declaration of Helsinki [57]. Then, the patients express their voluntary agreement to participate by signing an informed consent form within the REDCap platform at T1. Discussion This study protocol outlines the methodology for a PATI study, a pragmatic multicentre, C-RCT comparing standard consultations in orthopaedic outpatient clinics for patients with OA of the hip or knee with the SDM intervention facilitated through an in-consult PtDA. The PtDA aims to facilitate dialogues concerning complex medical information for patients and their families and to clarify values and preferences, enabling them to make informed, personalised decisions in collaboration with healthcare providers. The facilitation of SDM and using an in-consult PtDA have been shown to improve decisional quality [12]. While past studies have highlighted the value of PtDA delivery in orthopaedic surgery, the number of studies examining the impact of PtDA among patients with OA of the hip or knee remains limited [27]. This study specifically focuses on patients with OA of the hip or knee, exploring the potential benefits and implications of implementing SDM and PtDA in this context. Its cluster-randomised design enhances the robustness of the C-RCT, allowing it to evaluate the effectiveness of the intervention across two centres. Describing the study protocol underscores the importance of methodological rigour in investigating the impact of SDM and PtDA in orthopaedic settings. The insights gained from this study can potentially inform and improve patient decision quality for those facing decisions related to OA treatment of the hip or knee. Limitations This study had several potential limitations that should be acknowledged. Firstly, the enrolment of participants by surgeons may not be rigorous, introducing possible selection bias. Secondly, the extent of SDM and use of the in-consult PtDA depend on the surgeon, which may be influenced by their reluctance, workload or inexperience in using a PtDA. However, the surgeon-specific effects may partly be accounted for by including the surgeon as a random effect in the statistical analyses. Thirdly, conducting the C-RCT may influence surgeons in the control group to outperform their usual practice regarding information and patient involvement, even though they have not been involved in developing the PtDA. Fourthly, while the surgeons, patients, project nurses and project manager are not blinded to the intervention, the statistician will be blinded. Fifthly, there are generally long waiting lists for both consultations in the outpatient clinic and surgery. Consequently, patients increasingly choose to undergo surgery at private hospitals because of the extended waiting times in the public system, which could affect their commitment during the follow-up period. Finally, some questionnaires focus on patients’ subjective experiences of involvement and inclusion in the decision-making process, which may be influenced by various external factors. Abbreviations ADL Activities of daily living Cat Categorical C-RCT Cluster-randomised controlled trial Con Continues CONSORT Consolidated Standards of Reporting Trials DQI Decision Quality Instrument EQ-5D-5L EuroQol five-dimension five-level questionnaire EQUATOR Enhancing the Quality and Transparency of Health Research FJS Forgotten Joint Score HK-DQI Hip/Knee Osteoarthritis Decision Quality Instrument IPC Informed patient–centred OA Osteoarthritis OHS Oxford Hip Score OKS Oxford Knee Score OPEN Open Patient Data Explorative Network PATI PATient Involvement PtDA Patient decision aid QoL Quality of life REDcap Research Electronic Data Capture SDM Shared decision-making SPIRIT Standard Protocol Items for Randomized Trials guidelines SUNDAE Standards for Universal Reporting of Decision Aids Evaluation THR Total hip replacement TKR Total knee replacement TJR Total joint replacement T1 Timepoint 1 T2 Timepoint 2 T3 Timepoint 3 UKR Unicompartmental knee replacement Declarations Ethics approval and consent to participate The potential risk of harm is considered minimal, as the intervention involves a new approach to communicate and involve the patients during the consultation. Participants will receive information orally during the consultation from the surgeon and written details via e-Boks, including a link to the electronic questionnaire. After providing oral consent, participants have a minimum of 24 hours to consider before signing or refusing to sign the informed consent form at T1. Data collection and processing were approved by the Region of Southern Denmark (Journal No. 22/9955). Approval from the Danish Health Research Ethics Committee is not required for studies involving questionnaires or observations, as they are not classified as interventions under the Committee Act (decision on non-approval project ID: S-20200137). The C-RCT are registered on www.ClinicalTrials.gov (NCT05972525), with registration date: 06.08.2023. Data will be stored in the Open Patient Explorative Patient Network (OPEN), in accordance with the European General Data Protection Regulation. Authorship eligibility will follow guidelines outlined [58]. Consent for publication Not required. Availability of data and materials Data sharing does not apply since no datasets were generated or analysed for this protocol article. Competing interests CV was reimbursed for travel expenses by Stryker, paid to the institution, which are unrelated to this study. All other authors declare no competing interests. Funding This C-RCT was provided unrestricted internal funding by the Departments of Orthopaedic Surgery at Lillebaelt Hospital–Vejle and University Hospital of Southern Denmark as well as the Department of Orthopaedic Surgery and Traumatology at Odense University Hospital. External funding was obtained from the Region of Southern Denmark (22/26219) and the Research Fund at Lillebaelt Hospital. Authors contributors TAP, MLL, CMJ, KDS and CV designed the C-RCT. ST contributed to developing the statistical analysis plan. TAP wrote the initial draft of the protocol. MLL, CMJ, KDS, ST and CV revised the protocol. All authors have approved the final version. Acknowledgements We express our gratitude to the orthopaedic surgeons, local project nurses and nurses in the outpatient clinics who are involved in interventions, patient enrolment and data management at the Departments of Orthopaedic Surgery at Lillebaelt Hospital–Vejle and University Hospital of Southern Denmark as well as the Department of Orthopaedic Surgery and Traumatology at Odense University Hospital, Odense and Svendborg. We also appreciate the support and assistance of OPEN in data management and access to REDCap and OPEN storage. Disclaimer The funders will not be involved in the study’s design, interventions, data collection, data management, statistical analysis, interpretation of results, manuscript writing or the decision to submit the manuscripts for publication. 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Patient expectations and satisfaction 6 and 12 months following total hip and knee replacement. Quali Life Res. 2020;29(3):705-19. Jain D, Bendich I, Nguyen LL, Nguyen LL, Lewis CG, Huddleston JI, et al. Do patient expectations influence patient-reported outcomes and satisfaction in total hip arthroplasty? A prospective, multicenter study. The Journal of arthroplasty. 2017;32(11):3322-7. Tilbury C, Haanstra TM, Verdegaal SHM, Nelissen R, de Vet HCW, Vliet Vlieland TPM, et al. Patients' pre-operative general and specific outcome expectations predict postoperative pain and function after total knee and total hip arthroplasties. Scand J Pain. 2018;18(3):457-66. Hamilton DF, Lane JV, Gaston P, Patton JT, MacDonald D, Simpson AHRW, et al. What determines patient satisfaction with surgery? A prospective cohort study of 4709 patients following total joint replacement. BMJ Open. 2013;3(4):e002525. Judge A, Arden NK, Kiran A, Price A, Javaid MK, Beard D, et al. Interpretation of patient-reported outcomes for hip and knee replacement surgery: identification of thresholds associated with satisfaction with surgery. J Bone Joint Surg Br. 2012;94(3):412-8. Stacey D, Lewis KB, Smith M, Carley M, Volk R, Douglas EE, et al. Decision aids for people facing health treatment or screening decisions. The Cochrane database of systematic reviews. 2024(1). Zikmund-Fisher BJ, Couper MP, Singer E, Levin CA, Fowler FJ, Jr., Ziniel S, et al. The DECISIONS study: a nationwide survey of United States adults regarding 9 common medical decisions. Medical decision making : an international journal of the Society for Medical Decision Making. 2010;30(5 Suppl):20s-34s. Elwyn G, Laitner S, Coulter A, Walker E, Watson P, Thomson R. Implementing shared decision making in the NHS. BMJ (Clinical research ed). 2010;341:c5146. Stacey D, Lewis KB, Smith M, Carley M, Volk R, Douglas EE, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database of Systematic Reviews. 2024(1). Stacey D, Hawker G, Dervin G, Tugwell P, Boland L, Pomey M-P, et al. Decision aid for patients considering total knee arthroplasty with preference report for surgeons: A pilot randomized controlled trial. BMC musculoskeletal disorders. 2014;15(1):54. Mangla M, Bedair H, Chang Y, Daggett S, Dwyer MK, Freiberg AA, et al. Protocol for a randomised trial evaluating the comparative effectiveness of strategies to promote shared decision making for hip and knee osteoarthritis (DECIDE-OA study). BMJ Open. 2019;9(2):e024906. Van der Sluis G, Jager J, Punt I, Goldbohm A, Meinders MJ, Bimmel R, et al. Current status and future prospects for shared decision making before and after total knee replacement surgery—A scoping seview. Int J Environ Res Public Health. 2021;18(2):668. Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ (Clinical research ed). 2013;346:e7586. Sepucha KR, Abhyankar P, Hoffman AS, Bekker HL, LeBlanc A, Levin CA, et al. Standards for UNiversal reporting of patient Decision Aid Evaluation studies: the development of SUNDAE Checklist. BMJ Quality & Safety. 2018;27(5):380. Campbell MK, Piaggio G, Elbourne DR, Altman DG. Consort 2010 statement: extension to cluster randomised trials. BMJ (Clinical research ed). 2012;345:e5661. Cook JA. The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials. 2009;10(1):9. Witteman HO, Maki KG, Vaisson G, Finderup J, Lewis KB, Dahl Steffensen K, et al. Systematic development of patient decision aids: An update from the IPDAS collaboration. Medical decision making : an international journal of the Society for Medical Decision Making. 2021;41(7):736-54. Elwyn G, O'Connor A, Stacey D, Volk R, Edwards A, Coulter A, et al. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ (Clinical research ed). 2006;333(7565):417. Steffensen KD, Vinter M, Crüger D, Dankl K, Coulter A, Stuart B, et al. Lessons in Integrating Shared Decision-Making Into Cancer Care. J Oncol Pract. 2018;14(4):229-35. Sepucha K, Stacey D, Clay C, Chang Y, Cosenza C, Dervin G, et al. Decision quality instrument for treatment of hip and knee osteoarthritis: A psychometric evaluation. BMC musculoskeletal disorders. 2011;12:149. Sepucha K. Hip and Knee Osteoarthritis. Informed, Patient-Centered Decision Measure. Users Guide. 2019 [Available from: https://mghdecisionsciences.org/wp-content/uploads/2020/01/2019-hip-and-knee-ipc-user-guide.pdf. Accessed January 24, 2024] Sepucha KR, Levin CA, Uzogara EE, Barry MJ, O'Connor AM, Mulley AG. Developing instruments to measure the quality of decisions: early results for a set of symptom-driven decisions. Patient Educ Couns. 2008;73(3):504-10. Barr PJ, Thompson R, Walsh T, Grande SW, Ozanne EM, Elwyn G. The psychometric properties of CollaboRATE: a fast and frugal patient-reported measure of the shared decision-making process. Journal of medical Internet research. 2014;16(1):e2. Jensen CE, Sørensen SS, Gudex C, Jensen MB, Pedersen KM, Ehlers LH. The Danish EQ-5D-5L Value Set: A Hybrid Model Using cTTO and DCE Data. Applied Health Economics and Health Policy. 2021;19(4):579-91. MK AM-P, Nielsen R, Paulsen A, Odgaard A, editors. Translation and classical test theory validation of the Danish version of the Oxford Knee Score. Abstract, Danish Orthopaedic Society, annual congress; 2019. Paulsen A, Odgaard A, Overgaard S. Translation, cross-cultural adaptation and validation of the Danish version of the Oxford hip score. Bone & Joint Research. 2012;1(9):225-33. Thomsen MG, Latifi R, Kallemose T, Barfod KW, Husted H, Troelsen A. Good validity and reliability of the forgotten joint score in evaluating the outcome of total knee arthroplasty. Acta orthopaedica. 2016;87(3):280-5. Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, et al. Validation of a decision regret scale. Medical decision making : an international journal of the Society for Medical Decision Making. 2003;23(4):281-92. Andersen S, B.; Lorenzen, M, D.; Andersen, M. Ø. Decision Regret Scale (dansk version): Ottawa Hospital Research Institute.; 2016 [Available from: https://decisionaid.ohri.ca/docs/develop/Tools/Regret_Scale_Danish.pdf. Accessed 06.03.2024] Elwyn G. CollaboRATE Glyn Elwyn2013 [Available from: http://www.glynelwyn.com/collaborate-measure.html. Accessed 12.02.2024] Larsson A, Rolfson O, Kärrholm J. Evaluation of Forgotten Joint Score in total hip arthroplasty with Oxford Hip Score as reference standard. Acta orthopaedica. 2019;90(3):253-7. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377-81. Hemming K, Girling AJ, Sitch AJ, Marsh J, Lilford RJ. Sample size calculations for cluster randomised controlled trials with a fixed number of clusters. BMC Medical Research Methodology. 2011;11(1):102. Christensen R, Bliddal H, Henriksen M. Enhancing the reporting and transparency of rheumatology research: a guide to reporting guidelines. Arthritis research & therapy. 2013;15:1-4. Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004;159(7):702-6. Brodney S, Fowler FJ, Jr., Barry MJ, Chang Y, Sepucha K. Comparison of Three Measures of Shared Decision Making: SDM Process_4, CollaboRATE, and SURE Scales. Medical decision making : an international journal of the Society for Medical Decision Making. 2019;39(6):673-80. Hulbæk M, Jørgensen M, Mainz H, Birkelund R, Nielson J, Debrabant B, et al. Danish Translation, Cultural Adaptation and Validation of the Shared Decision Making Questionnaire - Patient Version (SDM-Q-9-Pat). European Journal for Person Centered Healthcare. 2018;6:438. McBee M. Modeling Outcomes With Floor or Ceiling Effects: An Introduction to the Tobit Model. Gifted Child Quarterly. 2010;54(4):314-20. Jakobsen JC, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation be used for handling missing data in randomised clinical trials – a practical guide with flowcharts. BMC Medical Research Methodology. 2017;17(1):162. Association TWM. Declaration of Helsinki The World Medical Association: The World Medical Association; 2008 [Available from: https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/. Accessed 30.08.2021] Editors ICoMJ. Defining the Role of Authors and Contributors ICMJE International Committee of Medical Journal Editors2024 [Available from: https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html. Accessed 02.04.2024] Additional Declarations Competing interest reported. CV was reimbursed for travel expenses by Stryker, paid to the institution, which are unrelated to this study. All other authors declare no competing interests Cite Share Download PDF Status: Published Journal Publication published 02 Jul, 2025 Read the published version in BMC Musculoskeletal Disorders → Version 1 posted Editorial decision: Revision requested 06 Dec, 2024 Reviews received at journal 11 Nov, 2024 Reviewers agreed at journal 01 Nov, 2024 Reviews received at journal 18 Oct, 2024 Reviewers agreed at journal 07 Oct, 2024 Reviewers invited by journal 01 Oct, 2024 Submission checks completed at journal 18 May, 2024 Editor assigned by journal 18 May, 2024 First submitted to journal 01 May, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4354090","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":307226083,"identity":"d99e9794-723b-4391-9e1f-22012bbe55f7","order_by":0,"name":"Trine Ahlmann Pedersen","email":"data:image/png;base64,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","orcid":"","institution":"Department of Orthopaedic Surgery, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle","correspondingAuthor":true,"prefix":"","firstName":"Trine","middleName":"Ahlmann","lastName":"Pedersen","suffix":""},{"id":307226084,"identity":"942b8114-8575-44a3-94a1-00a536190b21","order_by":1,"name":"Martin Lindberg-Larsen","email":"","orcid":"","institution":"Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense","correspondingAuthor":false,"prefix":"","firstName":"Martin","middleName":"","lastName":"Lindberg-Larsen","suffix":""},{"id":307226085,"identity":"b28ff5f2-64e1-49ba-a85f-dcb6d1022a3f","order_by":2,"name":"Charlotte Myhre Jensen","email":"","orcid":"","institution":"Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense","correspondingAuthor":false,"prefix":"","firstName":"Charlotte","middleName":"Myhre","lastName":"Jensen","suffix":""},{"id":307226086,"identity":"bb09b85f-7b69-4f6f-83c6-0a3e239c571e","order_by":3,"name":"Signe Timm","email":"","orcid":"","institution":"Department of Oncology, University Hospital of Southern Denmark, Vejle","correspondingAuthor":false,"prefix":"","firstName":"Signe","middleName":"","lastName":"Timm","suffix":""},{"id":307226087,"identity":"4bc8981c-f406-410c-9882-08c85f9dd8ca","order_by":4,"name":"Karina Dahl Steffensen","email":"","orcid":"","institution":"Center for Shared Decision Making, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle","correspondingAuthor":false,"prefix":"","firstName":"Karina","middleName":"Dahl","lastName":"Steffensen","suffix":""},{"id":307226088,"identity":"63ea7dc4-5fa1-4afe-9c18-f8d1f477d9dc","order_by":5,"name":"Claus Varnum","email":"","orcid":"","institution":"Department of Orthopaedic Surgery, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle","correspondingAuthor":false,"prefix":"","firstName":"Claus","middleName":"","lastName":"Varnum","suffix":""}],"badges":[],"createdAt":"2024-05-01 11:46:14","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4354090/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4354090/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12891-025-08856-w","type":"published","date":"2025-07-02T15:58:21+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":57722341,"identity":"4691faf6-5a50-4045-bfab-b92726f7e43c","added_by":"auto","created_at":"2024-06-04 19:05:00","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":724607,"visible":true,"origin":"","legend":"\u003cp\u003eTwo newly developed in-consult PtDA for patients with severe OA in their hip or knee.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-4354090/v1/71a13911687fbd9b395084e5.png"},{"id":57721234,"identity":"ccd0c460-dd2f-44f6-b3d0-e563bb62ca8e","added_by":"auto","created_at":"2024-06-04 18:57:00","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":81431,"visible":true,"origin":"","legend":"\u003cp\u003eStudy intervention and assessment timeline for patients treated surgically and non-surgically.\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-4354090/v1/d392cdc9fbbed6992a2c83a9.png"},{"id":57721235,"identity":"29f57182-33a4-4a1d-ba88-50be13876525","added_by":"auto","created_at":"2024-06-04 18:57:00","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":452573,"visible":true,"origin":"","legend":"\u003cp\u003eCONSORT flow diagram, extended version for C-RCTs at both cluster and individual levels. Clusters: surgeons; T1: one-week post-visit; T2: three months after treatment; T3: 12 months after treatment.\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-4354090/v1/0ec9a560e09c276651c30045.png"},{"id":86181105,"identity":"84f90bf3-be6f-4216-a43c-f4d5a912c7f2","added_by":"auto","created_at":"2025-07-07 16:23:23","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2457520,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4354090/v1/140d170d-426e-46be-a5ca-ca8f3c2d5559.pdf"}],"financialInterests":"Competing interest reported. CV was reimbursed for travel expenses by Stryker, paid to the institution, which are unrelated to this study. All other authors declare no competing interests","formattedTitle":"Impact of an in-consult patient decision aid on decisional quality, involvement, and health outcome for patients with severe hip or knee osteoarthritis – a study protocol for a multicentre, cluster randomised controlled trial (PATI-study)","fulltext":[{"header":"Background","content":"\u003cp\u003eOsteoarthritis (OA) is one of the most prevalent joint diseases, affecting approximately 600\u0026nbsp;million individuals worldwide [1]. The prevalence of OA is anticipated to increase due to gradually increasing obesity and age in the population with high physical activity [1\u0026ndash;4]. OA typically affects the hip or knee and induces pain and disability, leading to reduced function and quality of life (QoL), particularly in older adults [5, 6].\u003c/p\u003e \u003cp\u003eSevere cases often need hip or knee replacement [7\u0026ndash;9]. These surgeries are among the most frequently performed procedures worldwide [2, 9], with proven success in terms of pain relief, increased function and enhanced health-related QoL [10, 11].\u003c/p\u003e \u003cp\u003eWhile recommendations for treating early-stage OA are generally consistent [7], the decision to proceed with total joint replacement (TJR) in severe cases is influenced by patient and clinician preferences, considering factors such as symptom severity, radiological findings, age, comorbidities and QoL [4, 12]. Despite its benefits, some patients undergoing TJR fail to experience the intended results [3, 13]. Dissatisfaction rates after total hip replacement (THR), total knee replacement (TKR) and unicompartmental knee replacement (UKR) have been reported as 7%, 11\u0026ndash;18% and 10%, respectively [14\u0026ndash;17].\u003c/p\u003e \u003cp\u003eStudies have identified a clear association between postoperative dissatisfaction and the misalignment of preoperative expectations with actual outcomes [16, 18, 19], while patients whose expectations are met express higher satisfaction with their surgical outcomes [16, 20]. However, it is important to acknowledge that patient preferences can sometimes be influenced by expectations that do not align with the expected outcomes from TJR surgery. A considerable number of patients choose a surgical intervention to manage joint pain without a comprehensive understanding of what to expect from either surgery or alternative treatment options [21\u0026ndash;23].\u003c/p\u003e \u003cp\u003eEngaging patients in shared decision-making (SDM) is recognised as a crucial strategy to enhance decisional quality, especially in preference-sensitive decisions such as to undergo TJR [24, 25]. SDM can be facilitated by patient decision aids (PtDAs), which serve to inform patients about relevant treatment options and promote the SDM process. Despite over 209 randomised trials on using PtDAs in usual care [26], only a few have examined their impact among patients with OA of the hip or knee [27\u0026ndash;29].\u003c/p\u003e \u003cp\u003eThis PATient Involvement (PATI) study aims to investigate how SDM and using an in-consult PtDA affect decisional quality, patient involvement and health outcomes for patients with severe hip or knee OA referred for treatment.\u003c/p\u003e"},{"header":"Methods/design","content":"\u003cp\u003eThis study adheres to the Standard Protocol Items for Randomized Trials (SPIRIT) guidelines [30] and follows the recommendations of the Standards for Universal Reporting of Decision Aids Evaluation (SUNDAE) [31]. It is reported according to the Consolidated Standards of Reporting Trials (CONSORT) extended guidelines for cluster-randomised controlled trials (C-RCTs) [32].\u003c/p\u003e\n\u003cp\u003eStudy design\u003c/p\u003e\n\u003cp\u003eThis study was a two-armed, multicentre (two centres), pragmatic superiority [33], C-RCT. Each cluster consisted of one single hip or knee surgeon randomised (allocated 1:1) to either continue standard consultation or perform SDM with an in-consult PtDA developed explicitly for patients with hip or knee OA before this study. Nineteen clusters across two university hospitals in Denmark were randomised and stratified by centre. The scheduled consultation duration remained consistent, regardless of the intervention or control group. The primary and secondary outcomes based on patient-reported data are collected one week post-consultation (timepoint 1 [T1]), and a project nurse registered the patients\u0026rsquo; received or scheduled treatment six months post-consultation. The tertiary outcomes are assessed three months (timepoint 2 [T2]) and 12 months after treatment begins (timepoint 3 [T3]) and will be reported in follow-up studies.\u003c/p\u003e\n\u003cp\u003eSpecific objectives and hypotheses\u003c/p\u003e\n\u003cp\u003eObjective 1: To investigate whether using an in-consult PtDA enhances the decisional quality for patients with severe OA of the hip or knee referred for treatment.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHypothesis 1\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients receiving consultations using an in-consult PtDA will achieve higher decisional quality than those receiving standard consultations.\u003c/p\u003e\n\u003cp\u003eObjective 2: To investigate whether an in-consult PtDA increases patient-experienced involvement in SDM.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHypothesis 2\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients receiving consultations using an in-consult PtDA will report greater involvement in SDM than those who receive standard consultations.\u003c/p\u003e\n\u003cp\u003eObjective 3: To compare durations between consultations using SDM with an in-consult PtDA and standard consultations and explore the learning curve in using the in-consult PtDA, expressed as the consultation duration.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHypothesis 3.1\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe duration will not differ between consultations using the in-consult PtDA and standard consultations.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHypothesis 3.2\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe duration of consultations using the in-consult PtDA will decrease over time, indicating a learning curve associated with PtDA integration.\u003c/p\u003e\n\u003cp\u003eObjective 4: To determine whether consultations using the in-consult PtDA are superior to standard consultations regarding the level of changes in the patient-reported outcomes of pain, physical function and QoL at 3 and 12 months following surgery.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHypothesis 4\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConsultations using a PtDA are superior to standard consultations regarding the level of changes in the patient-reported outcomes of pain, physical function and QoL at 3 and 12 months after surgery.\u003c/p\u003e\n\u003cp\u003eObjective 5: To determine the association between informed patient-centred (IPC) decisions and the level of changes in the patient-reported outcomes of pain, physical function and QoL at 3 and 12 months after surgery.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHypothesis 5\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIPC decisions are positively associated with the level of changes in patient-reported outcomes related to pain, physical function and QoL at 3 and 12 months after surgery.\u003c/p\u003e\n\u003cp\u003eObjective 6: To evaluate whether consultations using a PtDA are superior to standard consultations regarding patient satisfaction at 3 and 12 months after surgery.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHypothesis 6\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConsultations using a PtDA are superior to standard consultations regarding patient satisfaction at 3 and 12 months after surgery.\u003c/p\u003e\n\u003cp\u003eParticipants, interventions and outcomes\u003c/p\u003e\n\u003cdiv id=\"Sec3\"\u003e\n \u003ch2\u003eParticipants\u003c/h2\u003e\n \u003cp\u003ePatients with OA in their hip or knee referred from general practice and scheduled for consultations with orthopaedic surgeons across the two study centres are screened for eligibility by the surgeons during the consultations regardless of the intervention arm. The surgeons inform the patients about the trial concept using a standardised protocol and obtain verbal informed consent.\u003c/p\u003e\n \u003cp\u003eThe inclusion criteria for patients are:\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003e\n \u003cp\u003eDiagnosed with severe primary OA eligible for primary THR, TKR or UKR\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eAged\u0026thinsp;\u0026ge;\u0026thinsp;18 years\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eAble to understand and read Danish\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eProvide informed consent\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eAble to receive mail in the electronic digital mailbox (E-Boks)\u003c/p\u003e\n \u003c/li\u003e\n \u003c/ul\u003e\n \u003cp\u003ePatients with the following will be excluded:\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003e\n \u003cp\u003ePrevious THR, TKR or UKR\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eCognitive impairment\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eNon-OA-related diagnoses\u003c/p\u003e\n \u003c/li\u003e\n \u003c/ul\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec4\"\u003e\n \u003ch2\u003eInterventions\u003c/h2\u003e\n \u003cp\u003eTwo new in-consult PtDAs for patients with severe OA in the hip or knee were developed from a generic PtDA template adhering to the criteria set by the International Patient Decision Aid Standards [34, 35] to be tested in the intervention group. Both PtDAs, entitled \u0026lsquo;Which Treatment Is Right for Me?\u0026rsquo; (Fig.\u0026nbsp;\u003cspan\u003e1\u003c/span\u003e), are presented in booklet form and represent the first editions of such aids for hip and knee OA in Denmark. Structured into five sections following the framework outlined by Steffensen et al. [36], these PtDAs feature option cards illustrating the pros and cons of each treatment, simplified statistics and patient stories.\u003c/p\u003e\n \u003cp\u003eSurgeons in the intervention group received a three-hour introduction and training course on the SDM concept and using an in-consult PtDA the day before the trial commenced at each of the two centres. This introduction also provided information about screening, recruitment, intervention and survey delivery at specific time points. Surgeons in the control group participated in a mandatory introductory course covering trial design with detailed task discussions. The sequence of activities within the orthopaedic clinic flow is illustrated in Fig.\u0026nbsp;\u003cspan\u003e2\u003c/span\u003e.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec5\"\u003e\n \u003ch2\u003eOutcomes\u003c/h2\u003e\n \u003cul\u003e\n \u003cli\u003e\n \u003cp\u003e\u003cem\u003eDemographics\u003c/em\u003e (T1) include participants\u0026rsquo; age, sex, education level, income status, PtDA handout (yes or no) and a single-item self-reported pain score on a five-point Likert scale. At the cluster level, the information includes surgical experience (years), surgeon\u0026rsquo;s age, sex and surgical joint speciality (hip or knee; Table\u0026nbsp;\u003cspan\u003e1\u003c/span\u003e).\u003c/p\u003e\n \u003c/li\u003e\n \u003c/ul\u003e\n \u003cdiv\u003e\n \u003ctable id=\"Tab1\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv\u003eTable 1\u003c/div\u003e\n \u003cdiv\u003e\n \u003cp\u003eData collection, consent and timing of the questionnaires.\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003ccolgroup cols=\"10\"\u003e\u003c/colgroup\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eOutcome\u003c/p\u003e\n \u003cp\u003eDomain\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eMeasurement\u003c/p\u003e\n \u003cp\u003einstruments\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eObjectives\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eConsultation\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003e(T1)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003e(T2)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eSix months post-consultation\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003e(T3)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eScore range\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eItems: \u003cem\u003eN\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e(range)\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePatient informed consent\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eInformed consent\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eDemographics\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eDemographic questionnaire\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eIPC decision\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eConcordance\u003c/strong\u003e and \u003cstrong\u003eKnowledge scores (HK-DQI)\u003c/strong\u003e [37]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1, 6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCat (yes [0]/no [1])\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eConcordance score\u003c/p\u003e\n \u003cp\u003eKnowledge sum score\u003c/p\u003e\n \u003cp\u003e(0\u0026ndash;1)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eKnowledge score\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eKnowledge score (HK-DQI)\u003c/strong\u003e [37]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCon (0\u0026ndash;100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eFive items\u003c/p\u003e\n \u003cp\u003e(0\u0026ndash;5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eTreatment received\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003ePatient journal\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCat (non-surgical [0]/surgical [1])\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eOne item\u003c/p\u003e\n \u003cp\u003e(0\u0026ndash;1)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePatient involvement\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eDecisional process score (HK-DQI)\u003c/strong\u003e [37]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCon (0\u0026ndash;100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eFive items\u003c/p\u003e\n \u003cp\u003e(0\u0026ndash;4)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePatient-reported engagement\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eCollaboRATE\u003c/strong\u003e [47]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCon (0\u0026ndash;100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eThree items (0\u0026ndash;9)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eTime duration\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eSelf-documented\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCon (minutes)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eQuality of life\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eEQ-5D-5L\u003c/strong\u003e [41]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4, 6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCon (\u0026minus;\u0026thinsp;0.757\u0026ndash;1.000)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eFive items\u003c/p\u003e\n \u003cp\u003e(1\u0026ndash;5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePhysical function\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eOHS\u003c/strong\u003e [43]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4, 6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCon (0\u0026ndash;48)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e12 items\u003c/p\u003e\n \u003cp\u003e(0\u0026ndash;4)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePhysical function\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eOKS\u003c/strong\u003e [42]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4, 6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCon (0\u0026ndash;48)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e12 items\u003c/p\u003e\n \u003cp\u003e(0\u0026ndash;4)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePhysical function\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eFJS\u003c/strong\u003e [48]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4, 6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCon (0\u0026ndash;100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e12 items\u003c/p\u003e\n \u003cp\u003e(1\u0026ndash;5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePatient satisfaction\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eOne question on satisfaction with received treatment\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCat (yes/no)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eOne item\u003c/p\u003e\n \u003cp\u003e(0\u0026ndash;1)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eDecision regret\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eDecision regret scale\u003c/strong\u003e [45]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCon (0\u0026ndash;100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eFive items\u003c/p\u003e\n \u003cp\u003e(0\u0026ndash;4)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003ctfoot\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"10\"\u003eTimepoints of data collection, send out through REDCap. Data types include Cat (categorical) and Con (continuous) variables, collected at T1 (one week post-visit), T2 (three months post-treatment), and T3 (12 months post-treatment).\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tfoot\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n \u003cp\u003ePrimary outcome:\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003e\n \u003cp\u003eThe \u003cem\u003eprimary outcome\u003c/em\u003e is the Hip/Knee OA Decision Quality Instrument (HK-DQI; T1), a patient-centred questionnaire designed to evaluate the quality of decision-making for joint replacement decisions. The HK-DQI is based on the Decision Quality Instrument (DQI), a disease-specific tool developed in the US in 2010 [37] that has separate versions tailored for hip (DQI-Hip) and knee (DQI-Knee) OA. These versions share identical content but differ in joint-specific terminology, collectively forming the HK-DQI [38]. The HK-DQI consists of three sections that assess decision-specific goals and concerns, decision-specific knowledge and the decision-making process [37]. It has demonstrated strong psychometric properties, including test-retest reliability, validity, sensitivity, acceptability and feasibility [37, 39]. Recently, both HK-DQI versions have been translated into Danish, and their psychometric properties have been rigorously evaluated.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eThe \u003cem\u003eIPC decision\u003c/em\u003e (T1) is calculated as the percentage of patients who are well-informed (answering at least three out of five knowledge questions correctly) and concordance between preferred and received treatment (surgical or non-surgical).\u003c/p\u003e\n \u003c/li\u003e\n \u003c/ul\u003e\n \u003cp\u003eSecondary outcomes:\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003e\n \u003cp\u003e\u003cem\u003eCollaboRATE\u003c/em\u003e (T1) is a three-item patient-reported outcome measure assessing the level of SDM in the clinical encounter, evaluating healthcare quality and provider performance on a scale from 0 (no effort) to 9 (maximum effort) [40].\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eThe \u003cem\u003esurgeon learning curve\u003c/em\u003e (T1) is measured by surgeons after each consultation throughout the trial period, documenting their duration.\u003c/p\u003e\n \u003c/li\u003e\n \u003c/ul\u003e\n \u003cp\u003eTertiary outcomes:\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003e\n \u003cp\u003e\u003cem\u003eEuroQol five-dimension five-level questionnaire\u003c/em\u003e (EQ-5D-5L; T1, T2 and T3) is a generic, concise, five-item preference-based health status measurement. It generates a single index value for health status ranging from \u0026minus;\u0026thinsp;0.757 to 1.000, with 1 indicating full health, 0 indicating death and a value below 0 indicating a health state worse than death [41].\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003e\u003cem\u003eOxford Hip Score\u003c/em\u003e (OHS) and \u003cem\u003eOxford Knee Score\u003c/em\u003e (OKS; T1, T2 and T3) are both 12-item questionnaires with a score from 0 (worst) to 48 (best) points. They assess joint-specific outcomes and are widely used in research related to THR and TKR/UKR. Recognised for their reproducibility, validity and sensitivity to clinically meaningful changes, the OHS and OKS are tools for evaluating hip and knee function [42, 43].\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003e\u003cem\u003eForgotten Joint Score\u003c/em\u003e (FJS; T1, T2 and T3) is a 12-item questionnaire assessing participants\u0026rsquo; awareness of their artificial joints during activities of daily living (ADL) with a score ranging on a scale from 0 to 100 with higher values indicating that the patients successfully \u0026lsquo;forgetting\u0026rsquo; the joint replacement during ADL. The FJS is used to assess the level of patient satisfaction after joint replacements, particularly in the hip and knee [44].\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eThe \u003cem\u003edecision regret scale\u003c/em\u003e (T2 and T3) is a five-item questionnaire used to assess the extent of regret or dissatisfaction individuals may experience regarding a specific decision, such as a healthcare choice or treatment option. The sum scores are scaled from 0 to 100, where 0 signifies no regret [45, 46].\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003e\u003cem\u003eSatisfaction\u003c/em\u003e (T2 and T3) comprises one question with response possibilities on a seven-point Likert scale assessing the patient\u0026rsquo;s overall satisfaction with health-related outcomes after treatment. The sum scores are scaled from 0 to 100, where 0 indicates high satisfaction.\u003c/p\u003e\n \u003c/li\u003e\n \u003c/ul\u003e\n \u003cdiv\u003e\n \u003c/div\u003e\n \u003cp\u003eDelivery of interventions and assessments\u003c/p\u003e\n \u003cp\u003ePatients with severe OA of the hip or knee referred from general practice and scheduled for appointments with orthopaedic surgeons at the two centres were screened for eligibility by the surgeon at the end of their consultation, irrespective of the intervention arm.\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003e\n \u003cp\u003e\u003cem\u003eIntervention consultation\u003c/em\u003e: Patients in the intervention group consulting a surgeon actively participate in the decision-making process through SDM facilitated by an in-consult PtDA in addition to standard preliminary examinations.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003e\u003cem\u003eStandard consultation\u003c/em\u003e: Patients in the control group undergo standard preliminary examinations with a surgeon and receive information following the usual practices at each centre.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003e\u003cem\u003eEnrolment\u003c/em\u003e: Surgeons in both groups screen, recruit, obtain informed consent and provide written information to eligible patients at the end of the consultation. Eligible patients are enrolled regardless of the chosen treatment option. For patients undergoing non-surgical treatment, the treatment begins on the enrolment date, while for surgical patients, it begins on the date of surgery. Local project nurses ensure the recording of all screened patients in the electronic Research Electronic Data Capture (REDCap) database.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003e\u003cem\u003eFirst survey at T1\u003c/em\u003e: One week after visiting the orthopaedic outpatient clinic, enrolled patients receive the (T1) survey in their electronic digital mailbox.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003e\u003cem\u003eSecond survey at T2\u003c/em\u003e: Follow-up assessments (T2) are collected through the patient\u0026rsquo;s electronic digital mailbox three months after receiving surgical or non-surgical treatment.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003e\u003cem\u003eTreatment received or scheduled\u003c/em\u003e is registered by project nurses six months after consultation through a review of the patients\u0026rsquo; electronic medical files.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003e\u003cem\u003eThird survey at T3\u003c/em\u003e: The final follow-up assessments (T4) are sent via the patient\u0026rsquo;s electronic digital mailbox 12 months after their treatment began.\u003c/p\u003e\n \u003c/li\u003e\n \u003c/ul\u003e\n \u003cp\u003eEnrolment and trial dates\u003c/p\u003e\n \u003cdiv id=\"Sec6\"\u003e\n \u003ch2\u003eSetting and enrolment strategies\u003c/h2\u003e\n \u003cp\u003eThe study recruited patients and surgeons from the orthopaedic departments specialising in fast-track hip and knee replacement at two university hospitals in the Region of Southern Denmark. These departments collectively perform almost 2,700 out of the approximately 26,000 THR, TKR and UKR surgeries performed annually in Denmark. An inclusion period of 12 months was expected, with an inclusion rate of 23% involving weekly enrolment of 11 patients and an anticipated dropout rate of 20%. The inclusion flow is illustrated as a CONSORT flow diagram (Fig.\u0026nbsp;\u003cspan\u003e3\u003c/span\u003e) [32].\u003c/p\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec7\"\u003e\n \u003ch2\u003eTrial dates\u003c/h2\u003e\n \u003cp\u003ePatient enrolment began in October 2023 at the first centre and in November 2023 at the second centre. The 12-month follow-up period commenced after patients received surgical or non-surgical treatment. Due to current waiting lists, the data collection period was estimated to last approximately two years, with an anticipated completion during the summer of 2026.\u003c/p\u003e\n \u003cdiv id=\"Sec8\"\u003e\n \u003ch2\u003eRandomisation and blinding\u003c/h2\u003e\n \u003cp\u003eIn October 2022, orthopaedic surgeons specialised in hip or knee replacements from both centres were randomised for the PATI study. Before the start of the trial, surgeons in the intervention group participated in the development phase of two new in-consult PtDAs (Fig.\u0026nbsp;\u003cspan\u003e2\u003c/span\u003e) that will be used in the intervention arm. A 1:1 randomisation was implemented using a computer-generated randomisation schedule, stratified by the surgeons\u0026rsquo; employment centres and using permuted blocks of size 10. Additional blocks, each with a size of two, were introduced to accommodate potential changes, such as surgeons leaving or newly hired to the departments during the trial period.\u003c/p\u003e\n \u003cp\u003eAn independent data manager created the computer-generated list of random numbers using the randomisation tool in REDCap [49]. The administrator responsible for the PATI study and the randomisation procedure will remain blinded to the sequence of random numbers within the blocks throughout the trial period. The randomisation of the clusters was disclosed to the two centres before the start of the trial. Patients will not be blinded to the interventions but will not be provided with explicit information about the intervention or control assignments. Similarly, the surgeons, project managers, and project nurses involved in the trial will not be blinded.\u003c/p\u003e\n \u003cp\u003eData collection, sample size and analyses\u003c/p\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec9\"\u003e\n \u003ch2\u003eData collection\u003c/h2\u003e\n \u003cp\u003eUpon their enrolment, patients\u0026rsquo; assessments will be sent through REDCap. They will directly enter all data related to patient-reported outcomes into REDCap, with the \u0026lsquo;required fields\u0026rsquo; option activated to ensure no missing items from completed questionnaires. Patients who fail to respond will receive reminders after three and six days. In case of continued non-response, the local project nurse will be notified and initiate up to two phone calls. If no response is obtained, the patients will be marked as \u0026lsquo;lost to follow-up\u0026rsquo; in the database for the specific time point.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec10\"\u003e\n \u003ch2\u003eSample size\u003c/h2\u003e\n \u003cp\u003eThe required sample size was estimated considering the possibility of some surgeons leaving the two centres during the trial period. Therefore, the sample size was calculated based on 15 clusters (surgeons) with an assumed intraclass correlation coefficient of 0.02, which represents how strongly individuals within clusters are related [50]. We also assumed a superiority difference between groups of 15% based on data from a comparable US setting, indicating that 40% of patients in the intervention group have high decisional quality compared to 25% in the control group [37, 38]. A total sample size of 615 patients will be enrolled to achieve a statistical power of 80% at a two-sided significance level of 0.05, which corresponds to approximately 41 patients in each cluster, accounting for an expected 20% loss to follow-up.\u003c/p\u003e\n \u003cp\u003eStatistical analysis plan\u003c/p\u003e\n \u003cp\u003eThe statistics will be reported according to the guidelines outlined by the Enhancing the Quality and Transparency of Health Research (EQUATOR) network [51] and CONSORT [32] statements. A detailed statistical analysis plan was developed with the study protocol to ensure transparent and reproducible statistical methods.\u003c/p\u003e\n \u003cp\u003eThe primary and secondary outcomes will be statistically analysed using mixed-effect models based on linear or binomial regression according to the data type of interest [52]. Due to the hierarchical structure of the data, surgeons will be incorporated as random effects. The analysis will be performed using the intention-to-treat approach, and in case of a cross-over, a per-protocol analysis will be conducted as sensitivity analysis [52]. Given the common presence of ceiling effects in several SDM assessment scores [53, 54], a sensitivity analysis will be conducted using a mixed-effect Tobit regression model [55] to explore their potential influences.\u003c/p\u003e\n \u003cp\u003eConsultation time will be analysed using a \u003cem\u003et\u003c/em\u003e-test if normally distributed and a Wilcoxon rank sum test otherwise. Histograms will be visually inspected to assess the normality assumption. The learning curve will be explored through descriptive analysis.\u003c/p\u003e\n \u003cp\u003eThe proportion of missing data will be explored. If less than 5% of the data is missing, a complete case analysis will be performed. If more than 5% of the data is missing, the missing data structures will be investigated, considering potential imputation methods [52, 56].\u003c/p\u003e\n \u003cp\u003eData monitoring and auditing\u003c/p\u003e\n \u003cp\u003eGiven this study\u0026rsquo;s minimal risk, an external Data and Safety Monitoring Board was not established. Instead, the study manager and local project nurses are conducting meticulous internal data monitoring. The study manager and project nurses hold weekly meetings, either in person or by phone, to ensure adherence to the protocol and the smooth progression of the project.\u003c/p\u003e\n \u003cp\u003eAll aspects of participant enrolment, including recruitment and survey response rates across the two centres, are being systematically tracked. No interim analyses are planned for this study.\u003c/p\u003e\n \u003cp\u003eEthics and dissemination\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec11\"\u003e\n \u003ch2\u003eProtocol amendments\u003c/h2\u003e\n \u003cp\u003eAny substantial adjustments to the protocol will be appropriately registered at \u003cspan\u003e\u003cspan\u003ewww.ClinicalTrials.gov\u003c/span\u003e\u003c/span\u003e, reported to The Regional Committees on Health Research Ethics for Southern Denmark and addressed in the primary C-RCT publication.\u003c/p\u003e\n \u003cp\u003ePatient and public involvement\u003c/p\u003e\n \u003cp\u003eBefore initiating the PATI study, a qualitative study contributed to developing two distinct in-consult PtDAs tailored to patients with hip and knee OA entitled \u0026ldquo;Which Treatment Is Right for Me?\u0026rdquo; Surgeons randomised to the intervention group and fifteen patients actively participated in focus group discussions and remained engaged throughout the development and testing processes.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec12\"\u003e\n \u003ch2\u003eStudy participant consent\u003c/h2\u003e\n \u003cp\u003eBefore the C-RCT began, a comprehensive kickoff meeting was conducted to engage all study staff from each centre. In this meeting, participants were briefed about its objectives, their respective roles and the anticipated timeline for enrolment. This meeting was held to foster an open communication environment, encouraging study staff and surgeons to contribute with suggestions or raise any concerns related to the trial material and setup.\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003ePatient consent\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eEligible patients are presented with verbal and written information about the study, including the privacy protection concept according to ethical standards outlined in the Declaration of Helsinki [57]. Then, the patients express their voluntary agreement to participate by signing an informed consent form within the REDCap platform at T1.\u003c/p\u003e\n\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study protocol outlines the methodology for a PATI study, a pragmatic multicentre, C-RCT comparing standard consultations in orthopaedic outpatient clinics for patients with OA of the hip or knee with the SDM intervention facilitated through an in-consult PtDA. The PtDA aims to facilitate dialogues concerning complex medical information for patients and their families and to clarify values and preferences, enabling them to make informed, personalised decisions in collaboration with healthcare providers. The facilitation of SDM and using an in-consult PtDA have been shown to improve decisional quality [12].\u003c/p\u003e \u003cp\u003eWhile past studies have highlighted the value of PtDA delivery in orthopaedic surgery, the number of studies examining the impact of PtDA among patients with OA of the hip or knee remains limited [27]. This study specifically focuses on patients with OA of the hip or knee, exploring the potential benefits and implications of implementing SDM and PtDA in this context. Its cluster-randomised design enhances the robustness of the C-RCT, allowing it to evaluate the effectiveness of the intervention across two centres.\u003c/p\u003e \u003cp\u003eDescribing the study protocol underscores the importance of methodological rigour in investigating the impact of SDM and PtDA in orthopaedic settings. The insights gained from this study can potentially inform and improve patient decision quality for those facing decisions related to OA treatment of the hip or knee.\u003c/p\u003e \u003cp\u003eLimitations\u003c/p\u003e \u003cp\u003eThis study had several potential limitations that should be acknowledged. Firstly, the enrolment of participants by surgeons may not be rigorous, introducing possible selection bias. Secondly, the extent of SDM and use of the in-consult PtDA depend on the surgeon, which may be influenced by their reluctance, workload or inexperience in using a PtDA. However, the surgeon-specific effects may partly be accounted for by including the surgeon as a random effect in the statistical analyses. Thirdly, conducting the C-RCT may influence surgeons in the control group to outperform their usual practice regarding information and patient involvement, even though they have not been involved in developing the PtDA. Fourthly, while the surgeons, patients, project nurses and project manager are not blinded to the intervention, the statistician will be blinded. Fifthly, there are generally long waiting lists for both consultations in the outpatient clinic and surgery. Consequently, patients increasingly choose to undergo surgery at private hospitals because of the extended waiting times in the public system, which could affect their commitment during the follow-up period. Finally, some questionnaires focus on patients\u0026rsquo; subjective experiences of involvement and inclusion in the decision-making process, which may be influenced by various external factors.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"652\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eADL\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eActivities of daily living\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eCat\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eCategorical\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eC-RCT\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eCluster-randomised controlled trial\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eCon\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eContinues\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eCONSORT\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eConsolidated Standards of Reporting Trials\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eDQI\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eDecision Quality Instrument\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eEQ-5D-5L\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eEuroQol five-dimension five-level questionnaire\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eEQUATOR\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eEnhancing the Quality and Transparency of Health Research\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eFJS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eForgotten Joint Score\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eHK-DQI\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eHip/Knee Osteoarthritis Decision Quality Instrument\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eIPC\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eInformed patient\u0026ndash;centred\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eOA\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eOsteoarthritis\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eOHS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eOxford Hip Score\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eOKS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eOxford Knee Score\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eOPEN\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eOpen Patient Data Explorative Network\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003ePATI\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003ePATient Involvement\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003ePtDA\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003ePatient decision aid\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eQoL\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eQuality of life\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eREDcap\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eResearch Electronic Data Capture\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eSDM\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eShared decision-making\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eSPIRIT\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eStandard Protocol Items for Randomized Trials guidelines\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eSUNDAE\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eStandards for Universal Reporting of Decision Aids Evaluation\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eTHR\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eTotal hip replacement\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eTKR\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eTotal knee replacement\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eTJR\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eTotal joint replacement\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eT1\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eTimepoint 1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eT2\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eTimepoint 2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eT3\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eTimepoint 3\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.865030674846626%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eUKR\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"81.13496932515338%\" valign=\"top\"\u003e\n \u003cp\u003eUnicompartmental knee replacement\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Declarations","content":"\u003ch2\u003eEthics approval and consent to participate\u0026nbsp;\u003c/h2\u003e\n\u003cp\u003eThe potential risk of harm is considered minimal, as the intervention involves a new approach to communicate and involve the patients during the consultation. Participants will receive information orally during the consultation from the surgeon and written details via e-Boks, including a link to the electronic questionnaire. After providing oral consent, participants have a minimum of 24 hours to consider before signing or refusing to sign the informed consent form at T1. Data collection and processing were approved by the Region of Southern Denmark (Journal No. 22/9955). Approval from the Danish Health Research Ethics Committee is not required for studies involving questionnaires or observations, as they are not classified as interventions under the Committee Act (decision on non-approval project ID: S-20200137). The C-RCT are registered on www.ClinicalTrials.gov (NCT05972525), with registration date: 06.08.2023. Data will be stored in the Open Patient Explorative Patient Network (OPEN), in accordance with the European General Data Protection Regulation. Authorship eligibility will follow guidelines outlined [58].\u003c/p\u003e\n\u003ch2\u003eConsent for publication\u003c/h2\u003e\n\u003cp\u003eNot required.\u003c/p\u003e\n\u003ch2\u003eAvailability of data and materials\u003c/h2\u003e\n\u003cp\u003eData sharing does not apply since no datasets were generated or analysed for this protocol article.\u003c/p\u003e\n\u003ch2\u003eCompeting interests\u003c/h2\u003e\n\u003cp\u003eCV was reimbursed for travel expenses by Stryker, paid to the institution, which are unrelated to this study. All other\u0026nbsp;authors declare no competing interests.\u003c/p\u003e\n\u003ch2\u003eFunding\u003c/h2\u003e\n\u003cp\u003eThis C-RCT was provided unrestricted internal funding by the Departments of Orthopaedic Surgery at Lillebaelt Hospital\u0026ndash;Vejle and University Hospital of Southern Denmark as well as the Department of Orthopaedic Surgery and Traumatology at Odense University Hospital. External funding was obtained from the\u0026nbsp;Region of Southern Denmark (22/26219) and\u0026nbsp;the Research Fund at Lillebaelt Hospital.\u003c/p\u003e\n\u003ch2\u003eAuthors contributors\u003c/h2\u003e\n\u003cp\u003eTAP, MLL, CMJ, KDS and CV designed the C-RCT. ST contributed to developing the statistical analysis plan. TAP wrote the initial draft of the protocol. MLL, CMJ, KDS, ST and CV revised the protocol. All authors have approved the final version.\u003c/p\u003e\n\u003ch2\u003eAcknowledgements\u003c/h2\u003e\n\u003cp\u003eWe express our gratitude to the orthopaedic surgeons, local project nurses and nurses in the outpatient clinics who are involved in interventions, patient enrolment and data management at the Departments of Orthopaedic Surgery at Lillebaelt Hospital\u0026ndash;Vejle and University Hospital of Southern Denmark as well as the Department of Orthopaedic Surgery and Traumatology at Odense University Hospital, Odense and Svendborg. We also appreciate the support and assistance of OPEN in data management and access to REDCap and OPEN storage.\u003c/p\u003e\n\u003ch2\u003eDisclaimer\u003c/h2\u003e\n\u003cp\u003eThe funders will not be involved in the study\u0026rsquo;s design, interventions, data collection, data management, statistical analysis, interpretation of results, manuscript writing or the decision to submit the manuscripts for publication.\u003c/p\u003e\n\u003ch1\u003eAuthor affiliations\u003c/h1\u003e\n\u003cp\u003e\u003csup\u003e1\u0026nbsp;\u003c/sup\u003eDepartment of Orthopaedic Surgery, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle, Denmark.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e2\u003c/sup\u003e Department of Regional Health Research, University of Southern Denmark, Odense, Denmark.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e3\u0026nbsp;\u003c/sup\u003eOrthopaedic Research Unit, Clinical Institute, University of Southern Denmark, Odense, Denmark.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e4\u003c/sup\u003e Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e5\u003c/sup\u003eDepartment of Oncology, University Hospital of Southern Denmark, Vejle, Denmark.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e6\u0026nbsp;\u003c/sup\u003eCenter for Shared Decision Making, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle, Denmark.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eSteinmetz JD, Culbreth GT, Haile LM, Rafferty Q, Lo J, Fukutaki KG, et al. 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BMJ Open. 2013;3(4):e002525.\u003c/li\u003e\n\u003cli\u003eJudge A, Arden NK, Kiran A, Price A, Javaid MK, Beard D, et al. Interpretation of patient-reported outcomes for hip and knee replacement surgery: identification of thresholds associated with satisfaction with surgery. J Bone Joint Surg Br. 2012;94(3):412-8.\u003c/li\u003e\n\u003cli\u003eStacey D, Lewis KB, Smith M, Carley M, Volk R, Douglas EE, et al. Decision aids for people facing health treatment or screening decisions. The Cochrane database of systematic reviews. 2024(1).\u003c/li\u003e\n\u003cli\u003eZikmund-Fisher BJ, Couper MP, Singer E, Levin CA, Fowler FJ, Jr., Ziniel S, et al. The DECISIONS study: a nationwide survey of United States adults regarding 9 common medical decisions. Medical decision making : an international journal of the Society for Medical Decision Making. 2010;30(5 Suppl):20s-34s.\u003c/li\u003e\n\u003cli\u003eElwyn G, Laitner S, Coulter A, Walker E, Watson P, Thomson R. 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Current status and future prospects for shared decision making before and after total knee replacement surgery\u0026mdash;A scoping seview. Int J Environ Res Public Health. 2021;18(2):668.\u003c/li\u003e\n\u003cli\u003eChan A-W, Tetzlaff JM, G\u0026oslash;tzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ (Clinical research ed). 2013;346:e7586.\u003c/li\u003e\n\u003cli\u003eSepucha KR, Abhyankar P, Hoffman AS, Bekker HL, LeBlanc A, Levin CA, et al. Standards for UNiversal reporting of patient Decision Aid Evaluation studies: the development of SUNDAE Checklist. BMJ Quality \u0026amp;amp; Safety. 2018;27(5):380.\u003c/li\u003e\n\u003cli\u003eCampbell MK, Piaggio G, Elbourne DR, Altman DG. Consort 2010 statement: extension to cluster randomised trials. BMJ (Clinical research ed). 2012;345:e5661.\u003c/li\u003e\n\u003cli\u003eCook JA. The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials. 2009;10(1):9.\u003c/li\u003e\n\u003cli\u003eWitteman HO, Maki KG, Vaisson G, Finderup J, Lewis KB, Dahl Steffensen K, et al. Systematic development of patient decision aids: An update from the IPDAS collaboration. Medical decision making : an international journal of the Society for Medical Decision Making. 2021;41(7):736-54.\u003c/li\u003e\n\u003cli\u003eElwyn G, O\u0026apos;Connor A, Stacey D, Volk R, Edwards A, Coulter A, et al. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ (Clinical research ed). 2006;333(7565):417.\u003c/li\u003e\n\u003cli\u003eSteffensen KD, Vinter M, Cr\u0026uuml;ger D, Dankl K, Coulter A, Stuart B, et al. Lessons in Integrating Shared Decision-Making Into Cancer Care. J Oncol Pract. 2018;14(4):229-35.\u003c/li\u003e\n\u003cli\u003eSepucha K, Stacey D, Clay C, Chang Y, Cosenza C, Dervin G, et al. Decision quality instrument for treatment of hip and knee osteoarthritis: A psychometric evaluation. BMC musculoskeletal disorders. 2011;12:149.\u003c/li\u003e\n\u003cli\u003eSepucha K. Hip and Knee Osteoarthritis. Informed, Patient-Centered Decision Measure. Users Guide. 2019 [Available from: https://mghdecisionsciences.org/wp-content/uploads/2020/01/2019-hip-and-knee-ipc-user-guide.pdf. Accessed January 24, 2024]\u003c/li\u003e\n\u003cli\u003eSepucha KR, Levin CA, Uzogara EE, Barry MJ, O\u0026apos;Connor AM, Mulley AG. Developing instruments to measure the quality of decisions: early results for a set of symptom-driven decisions. Patient Educ Couns. 2008;73(3):504-10.\u003c/li\u003e\n\u003cli\u003eBarr PJ, Thompson R, Walsh T, Grande SW, Ozanne EM, Elwyn G. The psychometric properties of CollaboRATE: a fast and frugal patient-reported measure of the shared decision-making process. Journal of medical Internet research. 2014;16(1):e2.\u003c/li\u003e\n\u003cli\u003eJensen CE, S\u0026oslash;rensen SS, Gudex C, Jensen MB, Pedersen KM, Ehlers LH. The Danish EQ-5D-5L Value Set: A Hybrid Model Using cTTO and DCE Data. Applied Health Economics and Health Policy. 2021;19(4):579-91.\u003c/li\u003e\n\u003cli\u003eMK AM-P, Nielsen R, Paulsen A, Odgaard A, editors. Translation and classical test theory validation of the Danish version of the Oxford Knee Score. Abstract, Danish Orthopaedic Society, annual congress; 2019.\u003c/li\u003e\n\u003cli\u003ePaulsen A, Odgaard A, Overgaard S. Translation, cross-cultural adaptation and validation of the Danish version of the Oxford hip score. Bone \u0026amp; Joint Research. 2012;1(9):225-33.\u003c/li\u003e\n\u003cli\u003eThomsen MG, Latifi R, Kallemose T, Barfod KW, Husted H, Troelsen A. Good validity and reliability of the forgotten joint score in evaluating the outcome of total knee arthroplasty. Acta orthopaedica. 2016;87(3):280-5.\u003c/li\u003e\n\u003cli\u003eBrehaut JC, O\u0026apos;Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, et al. Validation of a decision regret scale. Medical decision making : an international journal of the Society for Medical Decision Making. 2003;23(4):281-92.\u003c/li\u003e\n\u003cli\u003eAndersen S, B.; Lorenzen, M, D.; Andersen, M. \u0026Oslash;. Decision Regret Scale (dansk version): Ottawa Hospital Research Institute.; 2016 [Available from: https://decisionaid.ohri.ca/docs/develop/Tools/Regret_Scale_Danish.pdf. Accessed 06.03.2024]\u003c/li\u003e\n\u003cli\u003eElwyn G. CollaboRATE Glyn Elwyn2013 [Available from: http://www.glynelwyn.com/collaborate-measure.html. Accessed 12.02.2024]\u003c/li\u003e\n\u003cli\u003eLarsson A, Rolfson O, K\u0026auml;rrholm J. Evaluation of Forgotten Joint Score in total hip arthroplasty with Oxford Hip Score as reference standard. Acta orthopaedica. 2019;90(3):253-7.\u003c/li\u003e\n\u003cli\u003eHarris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377-81.\u003c/li\u003e\n\u003cli\u003eHemming K, Girling AJ, Sitch AJ, Marsh J, Lilford RJ. Sample size calculations for cluster randomised controlled trials with a fixed number of clusters. BMC Medical Research Methodology. 2011;11(1):102.\u003c/li\u003e\n\u003cli\u003eChristensen R, Bliddal H, Henriksen M. Enhancing the reporting and transparency of rheumatology research: a guide to reporting guidelines. Arthritis research \u0026amp; therapy. 2013;15:1-4.\u003c/li\u003e\n\u003cli\u003eZou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004;159(7):702-6.\u003c/li\u003e\n\u003cli\u003eBrodney S, Fowler FJ, Jr., Barry MJ, Chang Y, Sepucha K. Comparison of Three Measures of Shared Decision Making: SDM Process_4, CollaboRATE, and SURE Scales. Medical decision making : an international journal of the Society for Medical Decision Making. 2019;39(6):673-80.\u003c/li\u003e\n\u003cli\u003eHulb\u0026aelig;k M, J\u0026oslash;rgensen M, Mainz H, Birkelund R, Nielson J, Debrabant B, et al. Danish Translation, Cultural Adaptation and Validation of the Shared Decision Making Questionnaire - Patient Version (SDM-Q-9-Pat). European Journal for Person Centered Healthcare. 2018;6:438.\u003c/li\u003e\n\u003cli\u003eMcBee M. Modeling Outcomes With Floor or Ceiling Effects: An Introduction to the Tobit Model. Gifted Child Quarterly. 2010;54(4):314-20.\u003c/li\u003e\n\u003cli\u003eJakobsen JC, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation be used for handling missing data in randomised clinical trials \u0026ndash; a practical guide with flowcharts. BMC Medical Research Methodology. 2017;17(1):162.\u003c/li\u003e\n\u003cli\u003eAssociation TWM. Declaration of Helsinki The World Medical Association: The World Medical Association; 2008 [Available from: https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/. Accessed 30.08.2021]\u003c/li\u003e\n\u003cli\u003eEditors ICoMJ. Defining the Role of Authors and Contributors ICMJE International Committee of Medical Journal Editors2024 [Available from: https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html. Accessed 02.04.2024]\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-musculoskeletal-disorders","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bmsd","sideBox":"Learn more about [BMC Musculoskeletal Disorders](http://bmcmusculoskeletdisord.biomedcentral.com/)","snPcode":"","submissionUrl":"https://author-welcome.nature.com/12891","title":"BMC Musculoskeletal Disorders","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Osteoarthritis, total hip replacement, total knee replacement, unicompartmental knee replacement, shared decision-making, decisional quality, patient-reported outcome, cluster-randomised trial","lastPublishedDoi":"10.21203/rs.3.rs-4354090/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4354090/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u0026nbsp;\u003c/strong\u003eOsteoarthritis (OA) of the hip or knee is a widespread joint disease, often leading to replacement surgery. However, despite the high success rate of replacement surgery, some patients fail to experience the intended benefits. Given the importance of patient involvement, this trial aims to assess the effect of shared decision-making (SDM) on decisional quality for patients with severe OA. Specifically, it investigates whether an in-consult patient decision aid (PtDA) enhances decisional quality, involvement, and health outcomes for patients with severe hip or knee OA.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u0026nbsp;\u003c/strong\u003eThis protocol outlines a pragmatic two-armed multicentre cluster-randomised controlled trial (C-RCT) involving 19 orthopaedic surgeons randomised 1:1, stratified by centre, to either continue standard consultations or SDM with a newly developed in-consult PtDA. This trial intends to recruit 615 patients diagnosed with severe OA in their hip or knee. Surveys measuring decisional quality and disease-specific and generic health outcomes will be sent out at multiple time points: one-week post-consultation and three and 12 months post-consultation or post-surgery. The primary outcome (decisional quality) will be measured using the Hip/Knee OA Decision Quality Instrument and assessed based on the percentage of patients who are well-informed and receive their preferred treatment. The secondary outcomes include patient involvement in the decision-making process and consultation durations. The tertiary outcomes include patients’ satisfaction, regret and health-related outcomes.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion:\u0026nbsp;\u003c/strong\u003eThis study aims to contribute insights into the use of SDM facilitated by a PtDA and its impact on improving decisional quality for future patients with hip or knee OA.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration:\u0026nbsp;\u003c/strong\u003ewww.ClinicalTrials.gov (NCT05972525), Data of registration: 06.08.2023\u003c/p\u003e","manuscriptTitle":"Impact of an in-consult patient decision aid on decisional quality, involvement, and health outcome for patients with severe hip or knee osteoarthritis – a study protocol for a multicentre, cluster randomised controlled trial (PATI-study)","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-06-04 18:56:55","doi":"10.21203/rs.3.rs-4354090/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-12-06T12:08:56+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-11-12T04:44:39+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"180587170332839588641944006782516036976","date":"2024-11-01T08:56:30+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-10-18T13:15:28+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"320260279421159966256443883354308807374","date":"2024-10-07T15:03:35+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-10-01T09:40:32+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-05-18T14:11:12+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-05-18T14:11:12+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Musculoskeletal Disorders","date":"2024-05-01T11:44:52+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-musculoskeletal-disorders","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bmsd","sideBox":"Learn more about [BMC Musculoskeletal Disorders](http://bmcmusculoskeletdisord.biomedcentral.com/)","snPcode":"","submissionUrl":"https://author-welcome.nature.com/12891","title":"BMC Musculoskeletal Disorders","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"1446442b-a40a-4718-8226-2020b8d205ed","owner":[],"postedDate":"June 4th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-07-07T16:22:18+00:00","versionOfRecord":{"articleIdentity":"rs-4354090","link":"https://doi.org/10.1186/s12891-025-08856-w","journal":{"identity":"bmc-musculoskeletal-disorders","isVorOnly":false,"title":"BMC Musculoskeletal Disorders"},"publishedOn":"2025-07-02 15:58:21","publishedOnDateReadable":"July 2nd, 2025"},"versionCreatedAt":"2024-06-04 18:56:55","video":"","vorDoi":"10.1186/s12891-025-08856-w","vorDoiUrl":"https://doi.org/10.1186/s12891-025-08856-w","workflowStages":[]},"version":"v1","identity":"rs-4354090","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4354090","identity":"rs-4354090","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}