Use of implementation mapping to develop a multifaceted implementation strategy for an electronic prospective surveillance model for cancer rehabilitation.

BACKGROUND: Electronic Prospective Surveillance Models (ePSMs) remotely monitor the rehabilitation needs of people with cancer via patient-reported outcomes at pre-defined time points during cancer care and deliver support, including links to self-management education and community programs, and recommendations for further clinical screening and rehabilitation referrals. Previous guidance on implementing ePSMs lacks sufficient detail on approaches to select implementation strategies for these systems. The purpose of this article is to describe how we developed an implementation plan for REACH, an ePSM system designed for breast, colorectal, lymphoma, and head and neck cancers. METHODS: Implementation Mapping guided the process of developing the implementation plan. We integrated findings from a scoping review and qualitative study our team conducted to identify determinants to implementation, implementation actors and actions, and relevant outcomes. Determinants were categorized using the Consolidated Framework for Implementation Research (CFIR), and the implementation outcomes taxonomy guided the identification of outcomes. Next, determinants were mapped to the Expert Recommendations for Implementing Change (ERIC) taxonomy of strategies using the CFIR-ERIC Matching Tool. The list of strategies produced was refined through discussion amongst our team and feedback from knowledge users considering each strategy's feasibility and importance rating via the Go-Zone plot, feasibility and applicability to the clinical contexts, and use among other ePSMs reported in our scoping review. RESULTS: Of the 39 CFIR constructs, 22 were identified as relevant determinants. Clinic managers, information technology teams, and healthcare providers with key roles in patient education were identified as important actors. The CFIR-ERIC Matching Tool resulted in 50 strategies with Level 1 endorsement and 13 strategies with Level 2 endorsement. The final list of strategies included 1) purposefully re-examine the implementation, 2) tailor strategies, 3) change record systems, 4) conduct educational meetings, 5) distribute educational materials, 6) intervene with patients to enhance uptake and adherence, 7) centralize technical assistance, and 8) use advisory boards and workgroups. CONCLUSION: We present a generalizable method that incorporates steps from Implementation Mapping, engages various knowledge users, and leverages implementation science frameworks to facilitate the development of an implementation strategy. An evaluation of implementation success using the implementation outcomes framework is underway.

A Collection of Components to Design Clinical Dashboards Incorporating Patient-Reported Outcome Measures: Qualitative Study.

BACKGROUND: A clinical dashboard is a data-driven clinical decision support tool visualizing multiple key performance indicators in a single report while minimizing time and effort for data gathering. Studies have shown that including patient-reported outcome measures (PROMs) in clinical dashboards supports the clinician's understanding of how treatments impact patients' health status, helps identify changes in health-related quality of life at an early stage, and strengthens patient-physician communication. OBJECTIVE: This study aims to determine design components for clinical dashboards incorporating PROMs to inform software producers and users (ie, physicians). METHODS: We conducted interviews with software producers and users to test preselected design components. Furthermore, the interviews allowed us to derive additional components that are not outlined in existing literature. Finally, we used inductive and deductive coding to derive a guide on which design components need to be considered when building a clinical dashboard incorporating PROMs. RESULTS: A total of 25 design components were identified, of which 16 were already surfaced during the literature search. Furthermore, 9 additional components were derived inductively during our interviews. The design components are clustered in a generic dashboard, PROM-related, adjacent information, and requirements for adoption components. Both software producers and users agreed on the primary purpose of a clinical dashboard incorporating PROMs to enhance patient communication in outpatient settings. Dashboard benefits include enhanced data visualization and improved workflow efficiency, while interoperability and data collection were named as adoption challenges. Consistency in dashboard design components is preferred across different episodes of care, with adaptations only for disease-specific PROMs. CONCLUSIONS: Clinical dashboards have the potential to facilitate informed treatment decisions if certain design components are followed. This study establishes a comprehensive framework of design components to guide the development of effective clinical dashboards incorporating PROMs in health care practice.

Utility of The PROMIS-10 Global Mental Health T-Score to Identify Patients at Risk for Poor Post-Surgical Outcomes Following Total Hip Arthroplasty.

BACKGROUND: Mental illness is a known risk factor for poor postoperative outcomes following total hip arthroplasty (THA); however, the relationship between a patients overall mental health and recovery from THA is not as well established. Using the preoperative Patient-Reported Outcomes Measurement Information System (PROMIS-10) Mental Health T-score (MHT), the purpose of this study was to understand the association between mental health and postoperative outcomes up to one year following THA. METHODS: This was a retrospective chart review of patients undergoing elective primary THA. Patients who did not have a formal diagnosis of a mental illness condition were divided based on their MHT (above average [AA] > 50, average [A] 40 to 50, below average [BA] < 40). Postsurgical parameters included inpatient opioid consumption and patient satisfaction, and 1-year post-surgery self-reported pain and patient-reported outcomes scores. A total of 972 patients were included in this study (AA 61.2%, A 33.1%, BA 5.7%). RESULTS: After controlling for confounders, multivariate models demonstrated that the MHT was an independent predictor of pain, opioid consumption, patient-reported outcomes, and satisfaction. Patients in the AA group overall demonstrated better outcomes and required fewer opioids than those in the BA group. CONCLUSION: The MHT can be used as a preoperative screening tool that can identify an at-risk group that has not been previously described. An MHT < 40 was associated with poor postoperative outcomes, increased pain and opioid consumption, and lower overall satisfaction scores.

Patient Experience and Attitudes Toward Electronic Intake and Patient-Reported Outcomes Within an Outpatient Whole Health Center.

Background: The use of electronic intake forms within the electronic health record (EHR) is an emerging method for routinely collecting patient-reported outcomes (PRO). However, few studies have evaluated experiences/perspectives toward electronic forms among outpatients receiving care within Integrative Health and Medicine (IHM) clinics. The study purpose was to understand patients' perspectives of electronic intake and PRO forms in the outpatient IHM setting. Methods: Electronic intake (e.g., treatment expectations, medical history, chief complaints, prior experience with integrative modalities) and PRO forms (i.e., Patient Reported Outcome Measurement Information System [PROMIS]-29, Perceived Stress Scale 4, Oswestry Disability Index) were designed in collaboration with clinic leadership and the Information Technology team. Semi-structured interviews were used to gather perspectives of the functionality and acceptability of the forms among outpatients receiving care at the IHM center. Interviews were coded to describe themes regarding perceptions and suggestions for improvement. Results: Qualitative interviews were completed with 10 participants (median age 51 years, 70% female, 30% Black/African American). Participants considered electronic intake and PRO forms as relevant to their health concerns, valuable for conveying important health information to providers, and easy to navigate. Suggested changes to the intake form included adding relevant open-ended questions, save and print functions, and examples and definitions to prompt responses. Conclusion: Participants felt the electronic format was a feasible and acceptable method of collecting patient information and PROs. Future goals are to implement the revised forms in a common EHR to patients receiving care at multiple IHM clinics across the United States.

Reliability of self-measured objective functional impairment using the timed up and go test in patients with diseases of the spine.

BACKGROUND: Accurate assessment of a patient's functional status is crucial for determining the need for treatment and evaluating outcomes. Objective functional impairment (OFI) measures, alongside patient-reported outcome measures (PROMs), have been proposed for spine diseases. The Timed-Up and Go (TUG) test, typically administered by healthcare professionals, is a well-studied OFI measure. This study investigates whether patient self-measurement of TUG is similarly reliable. METHODS: In a prospective, observational study, patients with spinal diseases underwent two TUG assessments: one measured by a healthcare professional and one self-measured by the patient. Interrater reliability was assessed using the intraclass correlation coefficient (ICC) with a two-way random-effects model, considered excellent between 0.75 - 1.00. Paired t-tests directly compared both measurements. The impact of variables such as age, sex, disease type, symptom severity (via PROMs), comorbidities, and frailty on reliability was also analysed. RESULTS: Seventy-four patients were included, with a mean age of 62.9 years (SD 17.8); 29 (39.2%) were female. The majority (64.9%) were treated for degenerative disc disease. The lumbo-sacral region was most affected (71.6%), and 47.3% had previous surgeries. Patient self-measurement reliability was excellent (ICC 0.8740, p < 0.001), and the difference between healthcare professional (19.3 ± 9.4 s) and patient measurements (18.4 ± 9.7 s) was insignificant (p = 0.116). Interrater reliability remained high in patients > 65 years (ICC 0.8584, p < 0.001), patients with ASA grades 3&4 (ICC 0.7066, p < 0.001), patients considered frail (ICC 0.8799, p < 0.001), and in patients not using any walking aid (ICC 0.8012, p < 0.001). High symptom severity still showed strong reliability (ICC 0.8279, p < 0.001 for Oswestry Disability Index > 40; ICC 0.8607, p = 0.011 for Neck Disability Index > 40). CONCLUSIONS: Patients with spine diseases can reliably self-measure OFI using the TUG test. The interrater reliability between self-measurements and those by healthcare professionals was excellent across all conditions. These findings could optimize patient assessments, especially in resource-limited settings.

Navigating Choices in Nephrology: The Role of Patient-Reported Outcomes and Preferences in Economic Evaluations and Decisions in Health Care.

The increasing burden of chronic kidney disease (CKD) on the health care system highlights the need to prioritize services and manage the use of resources efficiently. Amid these financial constraints, key decision makers must weigh the impact of an intervention or program on health care expenditure when determining the allocation of limited resources. Patient-reported outcome measures (PROMs) are relevant in health economic decision-making within nephrology. Health-related quality of life, a patient-reported outcome, can provide data that inform economic evaluations of treatments for patients with CKD. PROMs help determine the value of different therapies by assessing their impact on patients' daily lives beyond clinical outcomes and can help policymakers make decisions about funding and reimbursement that consider the priorities and preferences of patients. Economic evaluations often employ cost-utility analyses, which use quality-adjusted life years as a key metric. Quality-adjusted life years combine both the quality and quantity of life lived, allowing for comparison of the effectiveness of different interventions in a standardized manner. By integrating utilities derived from PROMs, these analyses quantify the benefits of CKD treatments in terms of how patients feel and function. Furthermore, PROMs contribute to quality improvement initiatives by identifying areas where patient care can be enhanced, guiding the implementation of programs that improve health-related quality of life while maintaining cost-effectiveness. In value-based financing environments, the integration of PROMs ensures that patient-centered outcomes are prioritized, leading to more effective and equitable health care delivery. In this article, we discuss the role of PROMs in economic evaluations in CKD and provide an overview of approaches for using PROMs in economic evaluations to inform decision-making in nephrology.

Do obese patients undergoing surgery for grade 1 spondylolisthesis have worse outcomes at 5 years' follow-up? A QOD study.

OBJECTIVE: The long-term effects of increased body mass index (BMI) on surgical outcomes are unknown for patients who undergo surgery for low-grade lumbar spondylolisthesis. The goal of this study was to assess long-term outcomes in obese versus nonobese patients after surgery for grade 1 spondylolisthesis. METHODS: Patients who underwent surgery for grade 1 spondylolisthesis at the Quality Outcomes Database's 12 highest enrolling sites (SpineCORe group) were identified. Long-term (5-year) outcomes were compared for patients with BMI ≥ 35 versus BMI < 35. RESULTS: In total, 608 patients (57.6% female) were included. Follow-up was 81% (excluding patients who had died) at 5 years. The BMI ≥ 35 cohort (130 patients, 21.4%) was compared to the BMI < 35 cohort (478 patients, 78.6%). At baseline, patients with BMI ≥ 35 were more likely to be younger (58.5 ± 11.4 vs 63.2 ± 12.0 years old, p < 0.001), to present with both back and leg pain (53.8% vs 37.0%, p = 0.002), and to require ambulation assistance (20.8% vs 9.2%, p < 0.001). Furthermore, the cohort with BMI ≥ 35 had worse baseline patient-reported outcomes including visual analog scale (VAS) back (7.6 ± 2.3 vs 6.5 ± 2.8, p < 0.001) and leg (7.1 ± 2.6 vs 6.4 ± 2.9, p = 0.031) pain, disability measured by the Oswestry Disability Index (ODI) (53.7 ± 15.7 vs 44.8 ± 17.0, p < 0.001), and quality of life on EuroQol-5D (EQ-5D) questionnaire (0.47 ± 0.22 vs 0.56 ± 0.22, p < 0.001). Patients with BMI ≥ 35 were more likely to undergo fusion (85.4% vs 74.7%, p = 0.01). There were no significant differences in 30- and 90-day readmission rates (p > 0.05). Five years postoperatively, there were no differences in reoperation rates or the development of adjacent-segment disease for patients in either BMI < 35 or ≥ 35 cohorts who underwent fusion (p > 0.05). On multivariate analysis, BMI ≥ 35 was a significant risk factor for not achieving minimal clinically important differences (MCIDs) for VAS leg pain (OR 0.429, 95% CI 0.209-0.876, p = 0.020), but BMI ≥ 35 was not a predictor for achieving MCID for VAS back pain, ODI, or EQ-5D at 5 years postoperatively. CONCLUSIONS: Both obese and nonobese patients benefit from surgery for grade 1 spondylolisthesis. At the 5-year time point, patients with BMI ≥ 35 have similarly low reoperation rates and achieve rates of satisfaction and MCID for back pain (but not leg pain), disability (ODI), and quality of life (EQ-5D) that are similar to those in patients with a BMI < 35.

Do class III obese patients achieve similar outcomes and satisfaction to nonobese patients following surgery for cervical myelopathy? A QOD study.

OBJECTIVE: The aim of this study was to compare the rate of achievement of the minimal clinically important difference (MCID) in patient-reported outcomes (PROs) and satisfaction between cervical spondylotic myelopathy (CSM) patients with and without class III obesity who underwent surgery. METHODS: The authors analyzed patients from the 14 highest-enrolling sites in the prospective Quality Outcomes Database CSM cohort. Patients were dichotomized based on whether or not they were obese (class III, BMI ≥ 35 kg/m2). PROs including visual analog scale (VAS) neck and arm pain, Neck Disability Index (NDI), modified Japanese Orthopaedic Association (mJOA), EQ-5D, and North American Spine Society patient satisfaction scores were collected at baseline and 24 months after cervical spine surgery. RESULTS: Of the 1141 patients with CSM who underwent surgery, 230 (20.2%) were obese and 911 (79.8%) were not. The 24-month follow-up rate was 87.4% for PROs. Patients who were obese were younger (58.1 ± 12.1 years vs 61.2 ± 11.6 years, p = 0.001), more frequently female (57.4% vs 44.9%, p = 0.001), and African American (22.6% vs 13.4%, p = 0.002) and had a lower education level (high school or less: 49.1% vs 40.8%, p = 0.002) and a higher American Society of Anesthesiologists grade (2.7 ± 0.5 vs 2.5 ± 0.6, p < 0.001). Clinically at baseline, the obese group had worse neck pain (VAS score: 5.7 ± 3.2 vs 5.1 ± 3.3), arm pain (VAS score: 5.4 ± 3.5 vs 4.8 ± 3.5), disability (NDI score: 42.7 ± 20.4 vs 37.4 ± 20.7), quality of life (EQ-5D score: 0.54 ± 0.22 vs 0.56 ± 0.22), and function (mJOA score: 11.6 ± 2.8 vs 12.2 ± 2.8) (all p < 0.05). At the 24-month follow-up, however, there was no difference in the change in PROs between the two groups. Even after accounting for relevant covariates, no significant difference in achievement of MCID and satisfaction was observed between the two groups at 24 months. CONCLUSIONS: Despite the class III obese group having worse baseline clinical presentations, the two cohorts achieved similar rates of satisfaction and MCID in PROs. Class III obesity should not preclude and/or delay surgical management for patients who would otherwise benefit from surgery for CSM.

The patient-reported outcomes for the new brand-generic teriflunomide in relapsing-remitting multiple sclerosis.

BACKGROUND: Patient-reported outcomes (PROs) provide valuable insights into the impact of disease-modifying therapies (DMTs) on patients' daily lives and disease progression. This study evaluates treatment satisfaction and tolerability among patients using a brand-generic Teriflunomide (Tebazio®, 14 mg tablet) manufactured by Zistdaru Danesh Biopharmaceuticals. MATERIALS AND METHODS: A Phase IV observational study was conducted on patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who were either initiated on or switched to Teriflunomide 14 mg. The primary focus was on the medication's safety. Patient satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication [Version 1.4] (TSQM-14). Additionally, medication adherence and discontinuation rates were monitored. RESULTS: Of the 235 RRMS patients enrolled, participated in this study, all received the Teriflunomide treatment orally on a daily basis. Over the 18-month follow-up period, 25.96 % of patients discontinued the treatment. Discontinuation was mainly due to adverse events (11 %), lack of patient willingness to continue (12.7 %), and disease progression (4.2 %). The most commonly reported adverse events included dermatologic disorders, elevated liver enzymes, and gastrointestinal issues. TSQM-14 scores demonstrated significant improvements over the 18-month period. A high medication adherence rate of 98.1 % was also recorded. CONCLUSION: Patients reported notable satisfaction with Teriflunomide, as reflected in their TSQM scores, which suggests a likelihood of improved patient adherence. The 14 mg brand-generic Teriflunomide was well-accepted by Iranian RRMS patients, with no significant concerns arising during the study. These findings also highlight the significance of patient-reported outcomes in DMTs, with potential benefits for adherence and clinical practice.

Assessing the Efficacy: Mid-Term Clinical and Radiological Outcomes of the Comprehensive Short Stem System in Reverse Shoulder Arthroplasty.

BACKGROUND: For degenerative shoulder disease, reverse shoulder arthroplasty (RSA) has proven successful; however, problems such as scapular notching and instability still exist. These difficulties are intended to be addressed by recently improved prosthesis designs with reduced neck-shaft angles (NSA). Still, there are issues with complications, particularly with the humerus. In an effort to avoid these problems and maintain bone stock, a recently designed straight-short-stem humeral component was used; however, yet its clinical and radiological outcomes in RSA remain largely unexplored. MATERIAL AND METHODS: Using a 55mm straight short stem (Comprehensive Reverse Shoulder System; Zimmer Biomet), a retrospective analysis of 93 patients undergoing primary RSA was carried out. Clinical assessments, including scores and range of motion, were conducted both before and after surgery. Complications, bone adaptation, and stem alignment were all evaluated radiographically. Significant correlations between postoperative shoulder movements and function were linked with angles of prosthesis lateralization and distalization. RESULTS: Patients demonstrated significant improvements in clinical scores at 35-month follow-up on average: Constant-Murley (76.4 ± 13.4), ASES (84.8 ± 16.5), DASH (17.1 ± 15.8), and UCLA (7.1 ± 1.5). Radiographic assessments showed no stem loosening and stable implant attachment. There was no scapular notching, and there were noticeable improvements in shoulder range of motion and function. DISCUSSION AND CONCLUSION: This study validates the efficacy of a straight short stem for acceptable clinical outcomes and implant stability in RSA. Notably, it demonstrates specific angle ranges crucial for optimal post-surgical shoulder function. The findings suggest this stem design presents potential benefits in RSA, highlighting its safety and effectiveness while providing insights for future clinical strategies. The study contributes valuable data toward understanding and enhancing patient outcomes in shoulder arthroplasty procedures.

Identifying palliative care needs in patients with heart failure using patient reported outcomes.

CONTEXT: Heart failure (HF) is considered a multi-faceted and life-threatening syndrome characterized by high symptom-burden and significant mortality. OBJECTIVES: To describe the symptom-burden in patients with HF and identify their palliative care needs. In this respect, symptom burden related to sex, age and classification of HF using New York Heart Association Functional Classification (NYHA) were analyzed. METHODS: A cross-sectional questionnaire survey included adult HF patients according to NYHA II, III, and IV. Palliative care needs were assessed using validated patient reported outcomes measures; SF-36v1, HeartQoL, EORTC- QLQ-C15-PAL, MFI-20 and HADS. Patients were recruited from the Department of Cardiology, North Zealand Hospital, Denmark. RESULTS: In total, 314 patients (79%) completed the questionnaire (233 men). Mean age=74 yrs (range 35-94 yrs). In all, 42% had NYHA III or IV and 53% self-rated their health to be fair or poor. In all, 19% NYHA II and 67% NYHA III/IV patients had ≥4 severe palliative symptoms according to EORTC-QLQ-C15-PAL. In addition, NYHA III/IV had a mean of 8.9 symptoms and a mean of 5.4 severe symptoms. Women, older patients, and those with NYHA III/IV had worse outcomes regarding health-related quality of life, functional capacity, and symptom burden. CONCLUSIONS: Patients with HF have ahigh prevalence of symptoms and, thus, potential palliative care needs. Predominantly, women, older patients, and those with higher severity of disease have the highest symptom burden. PROMs can help cardiologists address the palliative care needs and systematic assessment may be a prerequisite to integrate symptom-modifying and palliative care interventions.

A new patient-reported outcome measure for the evaluation of ankle instability: description of the development process and validation protocol.

BACKGROUND: Acute ankle sprains represent one of the most common traumatic injuries to the musculoskeletal system. Many individuals with these injuries experience unresolved symptoms such as instability and recurrent sprains, leading to chronic ankle instability (CAI), which affects their ability to maintain an active lifestyle. While rehabilitation programs focusing on sensorimotor, neuromuscular, strength and balance training are primary treatments, some patients require surgery when rehabilitation fails. A critical analysis of the patient-reported outcome tools (PROs) used to assess CAI surgical outcomes raises some concerns about their measurement properties in CAI patients, which may ultimately affect the quality of evidence supporting current surgical practice. The aim of this research is to develop and validate a new PRO for the assessment of ankle instability and CAI treatment outcomes, following recent methodological guidelines, with the implicit aim of contributing to the generation of scientifically meaningful evidence for clinical practice in patients with ankle instability. METHODS: Following the COnsensus-based Standards for the selection of Health Measurement Instruments (COSMIN), an Ankle Instability Treatment Index (AITI) will be developed and validated. The process begins with qualitative research based on face‒to‒face interviews with CAI individuals to explore the subjective experience of living with ankle instability. The data from the interviews will be coded following an inductive approach and used to develop the AITI content. The preliminary version of the scale will be refined through an additional round of face‒to‒face interviews with a new set of CAI subjects to define the AITI content coverage, relevance and clarity. Once content validity has been examined, the AITI will be subjected to quantitative analysis of different measurement properties: construct validity, reliability and responsiveness. DISCUSSION: The development of AITI aims to address the limitations of existing instruments for evaluating surgical outcomes in patients with CAI. By incorporating patient input and adhering to contemporary standards for validity and reliability, this tool seeks to provide a reliable and meaningful assessment of treatment effects. TRIAL REGISTRATION: Not applicable.

The relationship between self-reported antipsychotics side effects and depression in Saudi Arabia.

Background: The utilization rate of antipsychotics to treat different mental disorders is rising. However, little is known about their side effects' impact on depression levels. Therefore, the objective of this study was to examine the association between antipsychotic side effects and depression among psychiatric patients treated with antipsychotics. Methods: This is a prospective, single-center, interview-based, cross-sectional study that examined the association between antipsychotic side effects and depression among adult patients (e.g., ≥18 yrs.) with psychiatric illnesses (e.g., depression, schizophrenia, bipolar disorder) visiting outpatient clinics in a university-affiliated tertiary care center. Antipsychotic side effects were assessed using the Arabic version of the Glasgow Antipsychotic Side-effect Scale (GASS), while depression was assessed using the Arabic version of the 9-item Patient Health Questionnaire (PHQ-9). Univariate and multiple linear regressions were conducted to examine the association between the PHQ-9 and GASS scores. Results: One hundred patients met the inclusion criteria and consented to participate. Most of the patients were females (72 %) with a mean age of 38 years. Schizophrenia (37 %) and bipolar disorder (54 %) were the most common mental disorders among the recruited patients. The majority of patients were treated with atypical (e.g., second-generation) antipsychotics (88 %) for at least six months (74 %). Controlling for age, gender, annual family income, education, employment status, marital status, number of comorbidities, duration of treatment with antipsychotics, the type of antipsychotic, and psychiatric illness, higher GASS scores, which indicate more severe antipsychotic side effects, predicted higher PHQ-9 score (e.g., higher levels of depression) (ß = 0.419, 95 % CI=[0.307-0.532], p-value < 0.0001). Conclusion: Early identification and management of antipsychotic side effects among psychiatric patients should enhance patient adherence and improve treatment outcomes. Future studies should verify the findings of this study using more robust study designs.

Minimizing Redislocation Rates and Restoring Function After Patella Dislocation: A Critically Appraised Topic.

CLINICAL SCENARIO: Patella dislocation is a common knee injury resulting in decreased function, increased knee pain, and a higher risk of recurrent patella dislocation. Patients with patella instability are treated surgically or conservatively with physical therapy to minimize redislocation risk and restore function. CLINICAL QUESTION: In individuals with a patella dislocation, how does treatment (conservative therapy versus medial patellofemoral ligament [MPFL] surgery) affect redislocation rates and patient-perceived function? SUMMARY OF KEY FINDINGS: This critically appraised topic included 3 studies assessing outcomes in individuals with patella instability treated with MPFL surgery or conservative management. Outcomes included comparing redislocation rates and Kujala scale perceived knee function between participant groups. Surgery included MPFL reconstruction (MPFL-R) in 1 randomized controlled trial and 1 prospective controlled trial and MPFL repair in another randomized controlled trial. Conservative treatment included physical therapy and bracing. All 3 studies demonstrated significantly lower redislocation rates in individuals managed with surgery versus conservative treatment. Reported knee function was significantly higher in the MPFL-R group compared with individuals conservatively managed at 2-year follow-up but not at 1 year. No significant difference in knee function was present between individuals receiving MPFL repair or conservative management at a 2-year follow-up. CLINICAL BOTTOM LINE: There is moderate-level evidence to support a significant decrease in patella redislocation rates in individuals managed with MPFL surgery compared with conservative treatment. The reviewed studies suggest a significant improvement in patient-perceived knee function at 2 years following MPFL-R but no difference at 1 year following MPFL-R or 2 years after MPFL repair. Strength of Recommendations: Grade B evidence supports lower patella redislocation rates with MPFL surgery compared with nonsurgical treatment. Furthermore, this evidence suggests a potential benefit in perceived knee function 2 years after MPFL-R compared with conservative management.

The PROPr can be measured using different PROMIS domain item sets.

BACKGROUND: The Patient-Reported Outcomes Measurement Information System (PROMIS) Preference Score (PROPr) is estimated from descriptive health assessments within the PROMIS framework. The underlying item response theory (IRT) allows researchers to measure PROMIS health domains with any subset of items that are calibrated to this domain. Consequently, this should also be true for the PROPr. We aimed to test this assumption using both an empirical and a simulation approach. METHODS: Empirically, we estimated 3 PROMIS Pain inference (PI) scores from 3 different item subsets in a sample of n=199 cancer patients: 4 PROMIS-29 items (estimate: θ4), the 2 original PROPr items (θ2), and 10 different items (θ10). We calculated mean differences and agreement between θ4, and θ2 and θ10, respectively, and between their resulting PROPr4, PROPr2, PROPr10, using intraclass correlation coefficients (ICC) and Bland-Altman (B-A) plots with 95 %-Limits of Agreement (LoA). For the simulation, we used the IRT-model to calculate all item responses of the entire 7 PROPr domain item banks from the empirically observed PROMIS-29+cognition θ. From these simulated item banks, we chose the 2 original PROPr items per domain to calculate PROPrsim and compared it to PROPr4 again using ICC and B-A plots. RESULTS: θ4 vs θ10 showed smaller bias (-0.012, 95 %-LoA -0.88;0.85) than θ4 vs θ2 (0.025, 95 %-LoA -0.95;1.00. ICC>0.85 (p<0.001) in both θ-comparisons. PROPr4 vs PROPr10 showed lower bias (0.0012, 95 %-LoA -0.039;0.042) than PROPr4 vs PROPr2 (-0.0029, 95 %-LoA -0.049;0.044). ICC>0.98 (p<0.0001) on both PROPr-comparisons. Mean PROPrsim was larger than mean PROPr4 (0.0228, 95 %-LoA -0.1103; 0.1558) and ICC was 0.95 (95 %CI 0.93; 0.97). CONCLUSION: Different item subsets can be used to estimate the PROMIS PI for calculation of the PROPr. Reduction to 2 items per domain rather than 4 does not significantly change the PROPr estimate on average. Agreements differ across the spectrum and in individual comparisons.

Assessment of needs, challenges, and re-design considerations for culturally sensitive provision and delivery of palliative care supports and services for older adults who prefer to age and die in place in diverse India.

As the global older adult population continues to grow, challenges related to managing multiple chronic conditions (MCCs) or multimorbidity underscore the growing need for palliative care. Palliative care preferences and needs vary significantly based on context, location, and culture. As a result, there is a need for more clarity on what constitutes palliative care in diverse settings. Our objective was to present an international perspective on palliative care in India, a culturally diverse and large ancient Eastern middle-income country. In this narrative review article, we considered three questions when re-designing palliative care for older adults aging-in-place in India: (I) what are the needs for palliative care for persons and their families? (II) Which palliative care domains are essential in assessing improvements in the quality of life (QoL)? (III) What patientreported measures are essential considerations for palliative care? To address these questions, we provide recommendations based on the following key domains: social, behavioral, psychological, cultural, spiritual, medical, bereavement, legal, and economic. Using an established and widely reported conceptual framework on aging and health disparities, we provide how these domains map across multiple levels of influence, such as individual or family members, community, institutions, and health systems for achieving the desired QoL. For greater adoption, reach, and accessibility across diverse India, we conclude palliative care must be carefully and systematically re-designed to be culturally appropriate and community-focused, incorporating traditions, individual preferences, language(s), supports and services from educational and health institutions, community organizations and the government. In addition, national government insurance schemes such as the Ayushman Bharat Yojna can include explicit provisions for palliative care so that it is affordable to all, regardless of ability to pay. In summary, our considerations for incorporating palliative care domains to care of whole person and their families, and provision of supports of services from an array of stakeholders broadly apply to culturally diverse older adults aging in place in India and around the globe who prefer to age and die in place.

Bridging clinical informatics and implementation science to improve cancer symptom management in ambulatory oncology practices: experiences from the IMPACT consortium.

Objectives: To report lessons from integrating the methods and perspectives of clinical informatics (CI) and implementation science (IS) in the context of Improving the Management of symPtoms during and following Cancer Treatment (IMPACT) Consortium pragmatic trials. Materials and Methods: IMPACT informaticists, trialists, and implementation scientists met to identify challenges and solutions by examining robust case examples from 3 Research Centers that are deploying systematic symptom assessment and management interventions via electronic health records (EHRs). Investigators discussed data collection and CI challenges, implementation strategies, and lessons learned. Results: CI implementation strategies and EHRs systems were utilized to collect and act upon symptoms and impairments in functioning via electronic patient-reported outcomes (ePRO) captured in ambulatory oncology settings. Limited EHR functionality and data collection capabilities constrained the ability to address IS questions. Collecting ePRO data required significant planning and organizational champions adept at navigating ambiguity. Discussion: Bringing together CI and IS perspectives offers critical opportunities for monitoring and managing cancer symptoms via ePROs. Discussions between CI and IS researchers identified and addressed gaps between applied informatics implementation and theory-based IS trial and evaluation methods. The use of common terminology may foster shared mental models between CI and IS communities to enhance EHR design to more effectively facilitate ePRO implementation and clinical responses. Conclusion: Implementation of ePROs in ambulatory oncology clinics benefits from common understanding of the concepts, lexicon, and incentives between CI implementers and IS researchers to facilitate and measure the results of implementation efforts.

Radical Prostatectomy Versus Stereotactic Radiotherapy for Clinically Localised Prostate Cancer: Results of the PACE-A Randomised Trial.

BACKGROUND AND OBJECTIVE: Randomised data on patient-reported outcomes (PROs) for stereotactic body radiotherapy (SBRT) and prostatectomy in localised prostate cancer are lacking. PACE-A compared patient-reported health-related quality of life after SBRT with that after prostatectomy. METHODS: PACE is a phase 3 open-label, randomised controlled trial. PACE-A randomised men with low- to intermediate-risk localised prostate cancer to SBRT or prostatectomy (1:1). Androgen deprivation therapy (ADT) was not permitted. The coprimary outcomes were the Expanded Prostate Index Composite (EPIC-26) number of absorbent urinary pads required daily and bowel domain score at 2 yr. The secondary endpoints were clinician-reported toxicity, sexual functioning, and other PROs. KEY FINDINGS AND LIMITATIONS: In total, 123 men were randomised (60 undergoing prostatectomy and 63 SBRT) from August 2012 to February 2022. The median follow-up time was 60.7 mo. The median age was 65.5 yr and the median prostate-specific antigen (PSA) value 7.9 ng/ml; 92% had National Comprehensive Cancer Network (NCCN) intermediate-risk disease. Fifty participants received prostatectomy and 60 received SBRT. At 2 yr, 16/32 (50%) prostatectomy and three of 46 (6.5%) SBRT participants used one or more urinary pads daily (p < 0.001; 15 and two, respectively, used one pad daily); the estimated difference was 43% (95% confidence interval [CI]: 25%, 62%). At 2 yr, bowel scores were better for prostatectomy (median [interquartile range] 100 [100-100]) than for SBRT (87.5 [79.2-100]; p < 0.001), with an estimated mean difference of 8.9 between these (95% CI: 4.2, 13.7); sexual scores were worse for prostatectomy (18 [13.8-40.3]) than for SBRT (62.5 [32.0-87.5]). The limitations were slow recruitment and incomplete 2-yr PRO response rates. CONCLUSIONS AND CLINICAL IMPLICATIONS: SBRT was associated with less patient-reported urinary incontinence and sexual dysfunction, and slightly more bowel bother than prostatectomy. These randomised data should inform treatment decision-making for patients with localised, intermediate-risk prostate cancer.

The association of acute and chronic phase cerebrovascular reactivity with patient reported quality of life following moderate-to-severe traumatic brain injury.

Global outcomes have been reported to be associated with cerebrovascular reactivity (CVR) in the acute phase following moderate and severe traumatic brain injury (TBI). The association of CVR in the acute and chronic phase of injury with patient-reported health-related quality of life metrics (HRQOL) metrics has never been explored. The aim of this study is to examine the association of CVR, as measured by the cerebral oxygen indices (COx and COx_a), in the acute and chronic phase following moderate and severe TBI, with patient reported HRQOL. In this prospective cohort study, performed in a Canadian quaternary care center, the association between continuous acute and chronic phase CVR with patient reported HRQOL outcomes following moderate and severe TBI was examined. The main outcomes of interest of this study were validated measures of patient-reported HRQOL over various domains as measured by both the 12-Item Short-Form Health Survey (SF-12) and a Quality of Life after Brain Injury (QOLIBRI) questionnaire. In the 29 subjects of this cohort, acute phase CVR was found to be significantly more active in those with a favorable Mental Component Summary (MCS) scores of the SF-12 at early follow-up when measured by COx (-0.015 [IQR: -0.067 to 0.032] vs 0.040 [IQR: 0.019 to 0.137] for Favorable first MCS vs Unfavorable respectively; Mann-Whitney U test p-value = 0.046) and COx_a (0.038 [IQR: 0.009 to 0.062] vs 0.112 [IQR: 0.065 to 0.167] for Favorable first MCS vs Unfavorable respectively; Mann-Whitney U test p-value = 0.014). Further, multivariable logistic regression analysis found acute phase COx and COx_a to improve model performance when predicting favorable versus unfavorable early MCS scores over established parameters such as age and measures of injury severity. Associations between outcomes and chronic phase CVR were limited, potentially due to short recording periods. This is the first ever pilot study to identify a relationship between acute phase CVR following moderate-to-severe TBI with mental and cognitive outcomes as experienced by patients. Given the small cohort, these findings will need to be confirmed in a larger multicenter study. This highlights the need for additional examination of the role dysfunctional CVR may play in mental and cognitive outcomes, as well as patient-reported outcomes more generally following TBI.