Shared Decision-making Process Research Articles

Can Adverse Event Patterns Inform Shared Decision-Making in ADHD Treatment? A Systematic Review of Evidence From Registration Trials for FDA-Approved Treatments in Adults.

Adult patients and clinicians are faced with several pharmacological options to manage attention-deficit/hyperactivity disorder (ADHD). If types or rates of adverse experiences vary among these options, these differences could inform the shared decision-making process. To discern differentiating evidence-based patterns of risk, we analyzed data from FDA package labels for drugs approved to treat adult ADHD and reports from the registration trials used to create these labels. Three analyses of adverse effects were conducted: placebo-corrected occurrence at rates of 1 in 5, 10, and 20 participants, association with discontinuation, and uniqueness of occurrence within the treatment options. Among the 7 agents approved to treat adult ADHD, the number of types of side effects experienced during a mix of fixed and flexible-dose studies was greatest among the nonstimulant medications, but the stimulant medications had higher rates of occurrence of side effects. The minimum frequency at which all medications had adverse events was 1 in 10 participants. Overall discontinuation rates did not differ among the stimulant medications nor between stimulants and nonstimulants. To our knowledge, this is the first study to compile and compare data from all FDA registration trials for medications approved to treat adult ADHD. This article describes a process by which readily available adverse event reporting data can be used as a tool to inform shared clinical decision-making. While differences in the methodology and outcome reporting of the trials included may limit generalizability, the number of individual patients included and the completeness of the discontinuation data can be used to inform discussions with patients about the relative likelihood of adverse experiences and other patient concerns.

MMpowerment: Empowering patients with multiple myeloma for shared decision-making by developing an intervention to integrate personal preferences into digital care pathways

ObjectiveAs part of a quality improvement initiative in the context of value-based health care we aimed to optimize the shared decision-making (SDM) process in the care pathway for Multiple Myeloma as part of a digital care pathway (DCP). For this, more insight was needed in health care professionals’ (HCPs’) perspectives on SDM, and how SDM elements could be addressed in a DCP for MM to facilitate HCPs’ performance of SDM. MethodsHCPs were interviewed as per the theory of planned behaviour and the model of organizational context and SDM (phase 1). Multidisciplinary development sessions were organized to discuss concepts of the solution with HCPs (phase 2). The solution was evaluated with two patients from the quality improvement team. ResultsIn phase 1, ten interviews were held. HCPs’ attitudes and the subjective norm towards SDM were positive, and the intention to perform SDM was high. The clinical environment (physical context, disease characteristics, assumptions about patient characteristics, and workflows) for MM posed challenges on the actual SDM behavior. Education and use of the DCP to create awareness of SDM were seen as possible facilitators for SDM. A prepared and active patient would facilitate the SDM process. In phase 2, three concept solutions were developed before arriving at the final solution. The final solution consisted of three elements to incorporate SDM steps in the DCP: 1) creating patient awareness and activation with two questions about their preferences prior to a consultation, 2) visualisation of preferences centrally in the DCP to trigger HCP to discuss them, 3) monitoring and improving SDM with patient-questionnaires after decision-making. Patients and HCPs were willing to implement it. ConclusionHCPs intention to engage in SDM was high, but their actual behaviour was challenged by the clinical environment. A 3-element DCP-based intervention was developed to increase SDM. Patient or public contributionInput on the solution was obtained from end-users including two patients and ten healthcare professionals.

Antipsychotic Use and Risk of Breast Cancer in Women With Severe Mental Illness: Replication of a Nationwide Nested Case-Control Database Study.

Breast cancer is more prevalent in women with severe mental illness than in the general population, and use of prolactin-increasing antipsychotics may be a contributing factor. A nested case-control study was conducted using the Swedish nationwide registers (inpatient/outpatient care, sickness absence, disability pension, prescribed drugs, cancers). All women aged 18-85 years with schizophrenia/schizoaffective/other nonaffective psychotic disorder/bipolar disorder and breast cancer (cases) were matched for age, primary psychiatric diagnosis, and disease duration with five women without cancer (controls). The association between cumulative exposure to prolactin-increasing/prolactin-sparing antipsychotics and breast cancer was analyzed using conditional logistic regression, adjusted for comorbidities and co-medications. Among 132 061 women, 1642 (1.24%) developed breast cancer between 2010 and 2021, at a mean age of 63.3 ± 11.8 years. Compared with 8173 matched controls, the odds of breast cancer increased in women with prior exposure to prolactin-increasing antipsychotics for 1-4 years (adjusted odds ratio [aOR] = 1.20, 95% confidence interval [CI] = 1.03-1.41), and for ≥ 5 years (aOR = 1.47, 95%CI = 1.26-1.71). There were no increased or decreased odds of breast cancer with exposure to prolactin-sparing antipsychotics of either 1-4 years (aOR = 1.17, 95%CI = 0.98-1.40) or ≥5 years (aOR = 0.99, 95%CI = 0.78-1.26). The results were consistent across all sensitivity analyses (ie, according to different age groups, cancer types, and primary psychiatric diagnosis). Although causality remains uncertain, exposure to prolactin-elevating antipsychotics for ≥ 1 year was associated with increased odds of breast cancer in women with severe mental illness. When prescribing antipsychotics, a shared decision-making process should consider individual risk factors for breast cancer.

Assessing patient information needs for new antidiabetic medications to inform shared decision-making: A best-worst scaling experiment in China.

Shared decision-making (SDM) is a patient-centred approach to improve the quality of care. An essential requirement for the SDM process is to be fully aware of patient information needs. Our study aimed to assess patient information needs for new antidiabetic medications using the best-worst scaling (BWS) experiment. BWS tasks were developed according to a literature review and the focus group discussion. We used a balanced incomplete block design and blocking techniques to generate choice sets. The final BWS contains 11 attributes, with 6-choice scenarios in each block. The one-to-one, face-to-face BWS survey was conducted among type 2 diabetic patients in Jiangsu Province. Results were analyzed using count-based analysis and modelling approaches. We also conducted a subgroup analysis to observe preference heterogeneity. Data from 539 patients were available for analysis. The most desired information domain was the comparative effectiveness of new antidiabetic medications. It consists of the incidence of macrovascular complications, the length of extended life years, changes in health-related quality of life, the incidence of microvascular complications, and the control of glycated haemoglobin. Of all the attributes, the incidence of macrovascular complications was the primary concern. Patients' glycemic control and whether they had diabetes complications exerted a significant influence on their information needs. Information on health benefits is of critical significance for diabetic patients. Patients have different information needs as their disease progresses. Personalized patient decision aids that integrate patient information needs and provide evidence of new antidiabetic medications are worthy of being established. Before data collection, a pilot survey was carried out among diabetic patients to provide feedback on the acceptability and intelligibility of the attributes.

The shared decision-making tool for caregivers of children with prenatal opioid exposure: A pilot and acceptability study.

This pilot and acceptability study sought to report provider acceptability and developmental concerns expressed by caregivers of children with prenatal opioid exposure using the Shared Decision-Making Tool (SDMT), an instrument created by study authors. Data were collected from five health care and early intervention providers and 83 caregivers from a medical clinic and early intervention service center. Descriptive statistics were used to identify frequency, mean level, and prioritization of developmental concerns using the SDMT, and to summarize provider acceptability about integrating the SDMT into their workflow. Communication was the most frequently cited concern in four consecutive age categories, followed by Inattention/impulsivity and Problem behavior. All providers "strongly agreed" or "agreed" with all statements on the provider feedback survey, except two instances. Results of this study support the SDMT as a potential tool to help engage caregivers and providers of children with prenatal opioid exposure in the shared decision-making process by standardizing communication related to areas of developmental concern and caregivers' priority needs. Findings from this pilot study will inform modifications to the SDMT and administration instructions before our next study, which will examine psychometric properties and caregiver acceptability of the scale.

Informed Dialysis Modality Selection Among Veterans With Advanced CKD: A Community-Level Needs Assessment

The Advancing Americans Kidney Health Executive order has directed substantial increases in home dialysis use for incident kidney replacement therapy (KRT). Clinical guidelines recommend patients' self-selection of KRT modality through a shared decision-making process, which, at the minimum, requires predialysis nephrology care and KRT-directed comprehensive prekidney failure patient education (CoPE). The current state of these essential services among Americans with advanced (stages 4 and 5) chronic kidney disease (CKD) and their informed preferences for home dialysis are unknown. We conducted a community-based, cross-sectional, observational cohort study across a large regional Veteran Healthcare System from October 1, 2020, to September 30, 2021. Of the 928 Veterans with advanced CKD, 287 (30.9%) were invited for needs assessment evaluations. Of the 218 (76% of invited cohort) responding, 178 (81.6%) were receiving nephrology care, with approximately half of those (43.6%) receiving such care from non-Veterans Affairs providers. The study was targeted to assess the prevalent state of ongoing nephrology care and KRT-directed pre-kidney failure education among Veterans with advanced CKD. The secondary outcome included evaluation of dialysis decision-making state among Veterans with advanced CKD. Veterans with advanced CKD with 2 sustained estimated glomerular filtration rates<30mL/min/1.73m2 were identified through an electronic database query, and a randomly selected cohort was invited for their current state of and outstanding needs for predialysis nephrology care and CoPE, essential for informed KRT selection. Basic awareness of kidney disease was high (92.2%) among Veterans with advanced CKD, although only 38.5% were aware of the severity of their CKD. KRT-directed education during clinical care was reported by 46.8% of Veterans, of which 21.1% reported having received targeted CoPE classes. Three-quarters (74.3%) of Veterans expressed interest in receiving CoPE services. Overall, awareness of CKD and its severity and receipt of KRT-directed education were significantly higher among Veterans with nephrology care than among those without. Of the 61 Veterans providing their KRT preferences, overall decision making was poor, with three-quarters (73.8%) of the cohort unable to choose any KRT modality, irrespective of ongoing nephrology care. Only 8 (13%) felt confident choosing home KRT modalities. The study results are primarily applicable to the Veterans with advanced CKD. Furthermore, a limited numbers of respondents provided data on their KRT decision-making state, prohibiting broad generalizations. In a first-of-its-kind community-based needs assessment evaluation among Veterans with advanced CKD, we found that awareness of kidney disease is positively associated with nephrology care; however, the informed KRT selection capabilities are universally poor, irrespective of nephrology care. Our results demonstrate a critical gap between the recommended and prevalent nephrology practices such as KRT-directed education and targeted CoPE classes required for informed patient-centered home dialysis selection in advanced CKD.

Minimally invasive surgical therapies for benign prostatic hyperplasia in the geriatric population: A systematic review.

Geriatric patients, prone to adverse events (AEs) and low compliance with drugs, may benefit from minimally invasive surgical therapies (MISTs) for managing benign prostatic hyperplasia (BPH). We evaluated the efficacy, safety, and procedural characteristics of MISTs in geriatric patients with BPH. PubMed/MEDLINE database was systematically searched for relevant articles through October 1, 2023. Eligible studies focused on geriatric patients (≥65 years) with BPH who were treated with MISTs and evaluated follow-up surgical, micturition, and/or sexual outcomes. Studies were included if there was separate reporting for age subgroups ≥65 years, or if the mean age minus standard deviation was ≥65 years, or if the first quartile was ≥65 years. Out of 292 screened studies, 32 (N = 3972 patients) met inclusion criteria and assessed prostatic artery embolization (PAE), Rezum, GreenLight, holmium laser enucleation of the prostate (HoLEP), thulium laser enucleation of the prostate (ThuLEP), diode laser enucleation of the prostate (DiLEP), and Aquablation. Except for Rezum, all MISTs required a planned overnight stay. While PAE and Rezum could be performed under local anesthesia, the other MISTs needed general or spinal anesthesia. Postoperative catheterization duration was longest for PAE (median 14 days) and Rezum (21 days) and shortest for GreenLight (1.9 days). At 12 months postoperatively, all MISTs exhibited significant percent changes in International Prostate Symptom Score (median -69.9%) and quality of life (median -72.5%). Clavien-Dindo Grade 1 AEs ranged widely, with PAE (5.8%-36.8%), Rezum (0%-62.1%), and GreenLight (0%-67.6%) having the largest range, and HoLEP (0%-9.5%), ThuLEP (2%-6.9%), and DiLEP (5%-17.5%) having the smallest. PAE, Rezum, DiLEP, and Aquablation reported no significant changes in the International Index of Erectile Function. Although all the MISTs reviewed in this study effectively treat BPH in geriatric patients, differences in procedural characteristics and safety profiles across MISTs were considerable. Physicians should use shared decision-making processes, considering risks and patient characteristics, when choosing a suitable treatment option for their patients.

ESR Essentials: screening for breast cancer - general recommendations by EUSOBI.

Breast cancer is the most frequently diagnosed cancer in women accounting for about 30% of all new cancer cases and the incidence is constantly increasing. Implementation of mammographic screening has contributed to a reduction in breast cancer mortality of at least 20% over the last 30 years. Screening programs usually include all women irrespective of their risk of developing breast cancer and with age being the only determining factor. This approach has some recognized limitations, including underdiagnosis, false positive cases, and overdiagnosis. Indeed, breast cancer remains a major cause of cancer-related deaths in women undergoing cancer screening. Supplemental imaging modalities, including digital breast tomosynthesis, ultrasound, breast MRI, and, more recently, contrast-enhanced mammography, are available and have already shown potential to further increase the diagnostic performances. Use of breast MRI is recommended in high-risk women and women with extremely dense breasts. Artificial intelligence has also shown promising results to support risk categorization and interval cancer reduction. The implementation of a risk-stratified approach instead of a "one-size-fits-all" approach may help to improve the benefit-to-harm ratio as well as the cost-effectiveness of breast cancer screening. KEY POINTS: Regular mammography should still be considered the mainstay of the breast cancer screening. High-risk women and women with extremely dense breast tissue should use MRI for supplemental screening or US if MRI is not available. Women need to participate actively in the decision to undergo personalized screening. KEY RECOMMENDATIONS: Mammography is an effective imaging tool to diagnose breast cancer in an early stage and to reduce breast cancer mortality (evidence level I). Until more evidence is available to move to a personalized approach, regular mammography should be considered the mainstay of the breast cancer screening. High-risk women should start screening earlier; first with yearly breast MRI which can be supplemented by yearly or biennial mammography starting at 35-40 years old (evidence level I). Breast MRI screening should be also offered to women with extremely dense breasts (evidence level I). If MRI is not available, ultrasound can be performed as an alternative, although the added value of supplemental ultrasound regarding cancer detection remains limited. Individual screening recommendations should be made through a shared decision-making process between women and physicians.

The AUA/SUFU Guideline on the Diagnosis and Treatment of Idiopathic Overactive Bladder.

The purpose of this guideline is to provide evidence-based guidance to clinicians of all specialties on the evaluation, management, and treatment of idiopathic overactive bladder (OAB). The guideline informs the reader on valid diagnostic processes and provides an approach to selecting treatment options for patients with OAB through the shared decision-making process, which will maximize symptom control and quality of life, while minimizing adverse events and burden of disease. An electronic search employing OVID was used to systematically search the MEDLINE and EMBASE databases, as well as the Cochrane Library, for systematic reviews and primary studies evaluating diagnosis and treatment of OAB from January 2013 to November 2023. Criteria for inclusion and exclusion of studies were based on the Key Questions and the populations, interventions, comparators, outcomes, timing, types of studies and settings (PICOTS) of interest. Following the study selection process, 159 studies were included and were used to inform evidence-based recommendation statements. This guideline produced 33 statements that cover the evaluation and diagnosis of the patient with symptoms suggestive of OAB; the treatment options for patients with OAB, including non-invasive therapies, pharmacotherapy, minimally invasive therapies, invasive therapies, and indwelling catheters; and the management of patients with BPH and OAB. Once the diagnosis of OAB is made, the clinician and the patient with OAB have a variety of treatment options to choose from and should, through shared decision-making, formulate a personalized treatment approach taking into account evidence-based recommendations as well as patient values and preferences.

Pharmacological and neurosurgical management of cerebral palsy and dystonia: Clinical practice guideline update.

Dystonia, typically characterized by slow repetitive involuntary movements, stiff abnormal postures, and hypertonia, is common among individuals with cerebral palsy (CP). Dystonia can interfere with activities and have considerable impact on motor function, pain/comfort, and ease of caregiving. Although pharmacological and neurosurgical approaches are used clinically in individuals with CP and dystonia that is causing interference, evidence to support these options is limited. This clinical practice guideline update comprises 10 evidence-based recommendations on the use of pharmacological and neurosurgical interventions for individuals with CP and dystonia causing interference, developed by an international expert panel following the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. The recommendations are intended to help inform clinicians in their use of these management options for individuals with CP and dystonia, and to guide a shared decision-making process in selecting a management approach that is aligned with the individual's and the family's values and preferences.

Factors influencing the decision-making process in breast reconstruction from the perspective of reconstructive surgeons: A qualitative study involving Korean plastic surgeons

BackgroundLittle research has been conducted on factors influencing the decision-making process for immediate breast reconstruction (IBR) options from the perspective of reconstructive surgeons, despite its significant impact on doctor-patient communication and shared decision-making. This study aims to explore the multiple factors and the mechanisms by which they interact using a qualitative methodology. We also address potential barriers to shared decision-making in IBR. MethodsSemistructured interviews were conducted with a purposive sample of reconstructive surgeons. Thematic analysis was used to identify key influences on IBR decision-making process from the perspective of reconstructive surgeons. ResultsFour major themes were identified: 1. Patient clinical scenarios; 2. Nonclinical practice environments; 3. Reconstructive surgeon preferences; and 4. Patient consultation. Reconstructive surgeons demonstrated diverse approaches to patient clinical scenarios. High-volume centers were significantly influenced by nonclinical factors such as scheduling and operating room allocation systems. Reconstructive surgeons often had strong personal preferences for specific IBR options, shaped by their expertise, experience, and clinical environment. Based on the preliminary decision, surgeons provided information with varying degrees of neutrality. Patients varied in their knowledge and participation, resulting in variation in the final decision authority among surgeons. ConclusionsThis study highlights the need to address nonclinical environmental constraints to improve shared decision-making process in IBR. Surgeons should recognize power imbalances in the doctor-patient relationship and be aware of their biases.

Foundational and Clinical Science Integration in a Team-Based Learning Module Modeling Care of a Patient With Dyslipidemia.

Foundational and clinical science integration, a long-standing goal of undergraduate medical education, benefits learners by promoting retention of critical knowledge and skills as well as their transfer to the clinical setting. We implemented a team-based learning (TBL) module in which foundational knowledge and skills from the disciplines of biochemistry, nutrition, and genetics were leveraged in a simulated patient encounter for diagnosis and management of a patient with dyslipidemia. The TBL was deployed in a first-year medical student cardiovascular system course with 125 students over three academic years. Following individual and team readiness assurance tests (iRAT and tRAT, respectively), teams participated in an initial application exercise requiring consideration of clinical and laboratory data and other risk factors to engage the patient in a shared decision-making process. Using dietary and family history narratives in subsequent application exercises, teams completed recommendations for an individualized diet plan and an assessment of potential disease inheritance patterns to formulate appropriate patient care management strategies. Student engagement with prelearning materials and session team activities was high as judged by RAT performance and application exercise outcomes: iRAT question performance ranged from 89% to 99% for individual items, and tRAT performance was routinely 100%. Learners reported that the exercises were impactful and believed the learned foundational knowledge and skills were transferable to future patient care. The dyslipidemia TBL module provides an illustration for early clinical learners of how foundational knowledge and skills can be operationalized and transferred for optimal patient care.

Health communication and shared decision-making between nurses and older adults in community setting: An integrative review.

To explore the role of health communication in Shared Decision-Making (SDM) between nursing staff and older people in the community setting. Society and healthcare services are marked by an exponentially ageing population, leading to a significant proportion of patients being older adults with highly demanding care needs. Scientific literature supports shared decision-making as a process that engages patients in their care. However, the increasing use of technology and the consequences of the COVID-19 pandemic have influenced how nurses communicate with older patients. Therefore, it is crucial to understand how to develop health communication to reach effective, shared decision-making processes. Whittemore and Knafl's integrative review method, the literature search comprised five databases: PubMed, CINALH, Web of Science, Scopus and PsycINFO. The 12 included studies were synthesised into three study patterns: (1) nurse-older patient health communication relationship, (2) older patients' perspectives and (3) nontherapeutic communication in end-of-life care. This review underscored the crucial role of effective health communication in shaping SDM dynamics between nursing staff and older people in the community setting. Key elements included transparent information exchange, establishing trust and maintaining communication channels with informal caregiving networks. SDM actions were aligned with preserving older people's autonomy, but communication challenges persisted, particularly in end-of-life situations. Advanced care planning was recommended to address these shortcomings and improve communication among older people, healthcare professionals and families. Implementing educational measures based on verbal and nonverbal health communication in nursing training could be beneficial. Nursing research could continue to develop and refine specific communication strategies adapted to the social determinants of health for diverse clinical situations regarding older adults in the community setting. The authors have adhered to relevant EQUATOR guidelines through the PRISMA 2020 checklist. No Patient or Public Contribution.

Patient preferences in genetic newborn screening for rare diseases: study protocol

IntroductionRare diseases (RDs) collectively impact over 30 million people in Europe. Most individual conditions have a low prevalence which has resulted in a lack of research and expertise in this...

Shared decision-making in metaclinical medicine: from informed consent to shared probability

At the dawn of "metaclinical medicine" era, shared decision-making represents the overcoming of modern medicine guidelines and classical medicine experience. The patient's life plan, the doctor's health plan, the scientist's evidence-based plan, the administrator's plan and the beliefs of the society for healthcare options should be integrated into the shared decision-making process to avoid patient's unrealistic expectations, doctor's self-referential and defensive medicine, the science without compassion of the scientist, the administered medicine of the politician, the herd mentality of artificial intelligence. For a doctor who must evaluate according to science and conscience, it becomes difficult to make decisions about a patient who thinks that there can be "no decisions about me without me". It risks being a pure declamatory statement in the absence of clinical knowledge and the associated concept of probability. The idea of moving from informed consent to shared probability is convenient for both the doctor and the patient but not for litigation professionals. Even in metaclinical medicine, clinical decision support systems, if well governed, would facilitate the choice of the best treatment according to the definition of absolute risk reduction and the number of patients to be treated to avoid an event, leaving it up to the doctor-patient relationship the narrative and the choice of the most appropriate treatment, which also requires taking care of the emotional and compassionate aspects.

Gender Differences in Pain, Function, and Quality of Life Five Years Following Primary Total Knee Arthroplasty

BackgroundMultiple authors have sought to determine what patient characteristics influence outcomes after total knee arthroplasty (TKA). The impact of gender on outcomes after TKA remains controversial. Previous studies had less than 5 years of follow-up after TKA. The aim of this evaluation was to determine what differences in pain, function, and quality of life (QoL) exist between female and male patients 5 years after primary TKA. MethodsA prospective, multicenter cohort of 11,602 unilateral primary TKA patients (7,284 females and 4,318 males) was prospectively evaluated. All patients were enrolled in the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement. Demographic data, musculoskeletal and medical comorbid conditions, and patient-reported outcome measures, including the Knee Injury and Osteoarthritis Outcome (KOOS) and Short-Form (36-item) Health Survey mental component score (MCS) and physical component score (PCS) were collected preoperatively and at 5 years after TKA. Descriptive statistics were generated, and stratified by gender, and differences in pain, function, and QoL between female and male patients were evaluated. Multivariate regression models with a 95% confidence interval (CI) were used to assess the role of patient gender as a predictive factor for KOOS pain and function in daily living (ADL) scores reported 5 years after primary TKA, while adjusting for other variables. ResultsPrior to surgery, female patients reported worse pain (KOOS pain 46 versus 52), function (KOOS ADL 53 versus 59), and QoL (KOOS QoL 26 versus 29) than male patients. The differences in preoperative scores ranged from 2.70 (KOOS QoL) to 6.12 (KOOS ADL). At 5 years after TKA, female patients reported slightly worse pain (87 versus 89), function (85 versus 87), and QoL (74 versus 75) when compared to male patients. The differences in the mean 5-year postoperative KOOS scores (range, 0.99 to 2.73), although statistically significant (P < .001), were clinically negligible. Female patients achieved greater improvement in pain (41 versus 37), function (32 versus 29), and QoL (48 versus 46) scores in comparison to male patients. Female patients also reported lower preoperative PCS global function (33 versus 35) scores, 5-year postoperative PCS scores (45 versus 46), and MCS global mental function scores (52 versus 54). Similarly, the differences in the 5-year postoperative Short-Form (36-item) Health Survey MCS and PCS scores were clinically negligible. Multivariate regression analysis showed that female gender was not independently predictive for either pain (β = −1.08; 95% CI [−1.25 to 1.03] [P = .85]) or function (β = 0.64; 95% CI [−0.51 to 1.79] [P = .28]) 5 years after surgery. ConclusionsThere are no clinically significant gender differences in pain, function, or QoL 5 years after TKA. Female patients typically have worse symptoms prior to surgery, improve more than male patients, and end up with pain, function, and QoL scores clinically equal to male patients. These data can enhance the shared decision-making process between female patients and surgeons and assist in setting appropriate patient expectations prior to TKA.

Investigating the Impact of AI on Shared Decision-Making in Post-Kidney Transplant Care (PRIMA-AI): Protocol for a Randomized Controlled Trial.

Patients after kidney transplantation eventually face the risk of graft loss with the concomitant need for dialysis or retransplantation. Choosing the right kidney replacement therapy after graft loss is an important preference-sensitive decision for kidney transplant recipients. However, the rate of conversations about treatment options after kidney graft loss has been shown to be as low as 13% in previous studies. It is unknown whether the implementation of artificial intelligence (AI)-based risk prediction models can increase the number of conversations about treatment options after graft loss and how this might influence the associated shared decision-making (SDM). This study aims to explore the impact of AI-based risk prediction for the risk of graft loss on the frequency of conversations about the treatment options after graft loss, as well as the associated SDM process. This is a 2-year, prospective, randomized, 2-armed, parallel-group, single-center trial in a German kidney transplant center. All patients will receive the same routine post-kidney transplant care that usually includes follow-up visits every 3 months at the kidney transplant center. For patients in the intervention arm, physicians will be assisted by a validated and previously published AI-based risk prediction system that estimates the risk for graft loss in the next year, starting from 3 months after randomization until 24 months after randomization. The study population will consist of 122 kidney transplant recipients >12 months after transplantation, who are at least 18 years of age, are able to communicate in German, and have an estimated glomerular filtration rate <30 mL/min/1.73 m2. Patients with multi-organ transplantation, or who are not able to communicate in German, as well as underage patients, cannot participate. For the primary end point, the proportion of patients who have had a conversation about their treatment options after graft loss is compared at 12 months after randomization. Additionally, 2 different assessment tools for SDM, the CollaboRATE mean score and the Control Preference Scale, are compared between the 2 groups at 12 months and 24 months after randomization. Furthermore, recordings of patient-physician conversations, as well as semistructured interviews with patients, support persons, and physicians, are performed to support the quantitative results. The enrollment for the study is ongoing. The first results are expected to be submitted for publication in 2025. This is the first study to examine the influence of AI-based risk prediction on physician-patient interaction in the context of kidney transplantation. We use a mixed methods approach by combining a randomized design with a simple quantitative end point (frequency of conversations), different quantitative measurements for SDM, and several qualitative research methods (eg, records of physician-patient conversations and semistructured interviews) to examine the implementation of AI-based risk prediction in the clinic. ClinicalTrials.gov NCT06056518; https://clinicaltrials.gov/study/NCT06056518. PRR1-10.2196/54857.

Effectiveness of computerised decision aids for patients with chronic diseases in shared decision-making: A systematic review and meta-analysis.

To synthesise the composition and effectiveness of computer-based patient decision aid (PDAs) in interventions for patients with chronic diseases. A systematic review with meta-analysis. Five databases were searched, and only randomised controlled trials (RCTs)were included. This review was conducted with the PRISMA guidelines. The JBI Appraisal Tools for randomised trials were used to assess the risk of bias. We used the random-effects model to conduct meta-analyses. Evidence from RCTs was synthesised using standardised mean differences or mean differences. The GRADE system was employed to assess the certainty of evidence and recommendations. This study was registered on PROSPERO (number: CRD42022369340). PubMed, Embase, Web of Science, CINAHL and Cochrane Library were searched for studies published before October 2022. The review included 22 studies, and most computer-based PDAs reported information on the disease, treatment options, pros and cons and risk comparison and value clarification. The use of computer-based PDAs showed a significant effect on decision conflict and knowledge, but not on decision regret, satisfaction, self-efficacy, anxiety and quality of life. The overall GRADE certainty of evidence was low. Although the quality of evidence was low, however, using computer-based PDAs could reduce decision conflict and enhance knowledge when making medical decisions. More research is needed to support the contention above. Computer-based PDAs could assist health-care providers and patients in the shared decision-making process and improving the quality of decision-making. This study adhered to PRISMA guidelines. NO PATIENT OR PUBLIC CONTRIBUTION.

Session-level effects of cognitive processing therapy and prolonged exposure on individual symptoms of posttraumatic stress disorder among U.S. veterans.

To compare the course of change in individual posttraumatic stress disorder (PTSD) symptoms during prolonged exposure therapy (PE) and cognitive processing therapy (CPT). We analyzed data from a previously published randomized clinical trial comparing PE and CPT among male and female U.S. military veterans with PTSD (Schnurr et al., 2022). Using data from a self-rated PTSD symptom measure administered before each therapy session, we evaluated individual symptom change from pretreatment to final therapy session (N = 802). Then, using network intervention analysis, we modeled session-by-session PTSD symptom networks that included treatment allocation (CPT vs. PE) as a node in the networks, allowing us to compare individual symptom change following each session in each treatment. Relative to CPT, PE was associated with greater reduction in 10 PTSD symptoms from first to final session of therapy. Numerous treatment-specific effects on individual symptoms emerged during the treatment period; these session-level effects occurred only in symptoms relatively specific to the diagnosis of PTSD (e.g., avoidance, hypervigilance). PE was associated with greater reduction in avoidance following the introduction and early weeks of imaginal exposure. The treatments yielded comparable effects on trauma-related blame and negative beliefs from pretreatment to final therapy session. However, there were differences in session-level change in these symptoms that may reflect differential timing of interventions that reduce distorted cognitions within each treatment. Findings may facilitate the shared decision-making process for patients choosing between CPT and PE. Session-level results provide direction for future research on the specific intervention components of CPT and PE. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

The influence of health literacy, anxiety and education on shared decision making and decisional conflict in older adults, and the mediating role of patient participation: A video observational study

ObjectiveTo explore the relationship between personal characteristics of older adults with multiple chronic conditions (MCCs) and perceived shared decision making (SDM) resp. decisional conflict. MethodsIn a video-observational study (N = 213) data were collected on personal characteristics. The main outcomes were perceived level of SDM and decisional conflict. The mediating variable was participation in the SDM process. A twostep mixed effect multilinear regression and a mediation analysis were performed to analyze the data. ResultsThe mean age of the patients was 77.3 years and 56.3% were female. Health literacy (β.01, p < .001) was significantly associated with participation in the SDM process. Education (β = −2.43, p = .05) and anxiety (β = −.26, p = .058) had a marginally significant direct effect on the patients’ perceived level of SDM. Education (β = 12.12, p = .002), health literacy (β = −.70, p = .005) and anxiety (β = 1.19, p = .004) had a significant direct effect on decisional conflict. The effect of health literacy on decisional conflict was mediated by participation in SDM. ConclusionHealth literacy, anxiety and education are associated with decisional conflict. Participation in SDM during consultations plays a mediating role in the relationship between health literacy and decisional conflict. Practice ImplicationsTailoring SDM communication to health literacy levels is important for high quality SDM.