Validation of the patient reported experiences and outcomes of safety in primary care compact Form Brazil.

OBJECTIVE: To analyze the psychometric properties of the cross-culturally adapted version of the Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) Compact Form Brazil. METHODS: A methodological study was conducted with 281 adult Primary Health Care users. Data collection took place online. Confirmatory Factor Analysis (CFA) was used to evaluate the psychometric properties of the PREOS-PC after the process of cross-cultural adaptation to the Brazilian context. Internal consistency was evaluated through Cronbach's alpha coefficient (α) and McDonald's omega coefficient (ω). RESULTS: The sample consisted of 73.3% women. The mean age was 36.1 years (SD = 12.2). Of the 23 items of the PREOS-PC that were eligible for CFA, a model with four correlated domains and 16 items presented satisfactory fit indexes. The domains were Practice Activation (PrA) (four items), Patient Activation (PaA) (two items), Experiences of patient safety events (EPaS) (five items) and Outcomes of patient safety (OPaS) (six items). One domain (GPeS) presented one question with a 0 to 10 response scale and two open questions, which cannot be inserted in the CPA due to the nature of the items, but can be included in the application of the scale, being evaluated individually. In this factorial model, five items (EPaS2, EPaS3, EPaS4, EPaS5, EPaS6 and EPaS8) presented factor loadings ≤ 0.30. The α and ω values demonstrated good internal consistency for all domains of the PREOS-PC. CONCLUSIONS: The Brazilian version of the PREOS-PC Compact Form Brazil composed of four domains (PrA, PA, EPaS and OPaS) and 16 items presented evidence of validation of its psychometric properties and can be used to evaluate the experiences and results of patient safety in Primary Health Care in the Brazilian context.

Hip Osteoarthritis in Patients Undergoing Surgery for Severe Adult Spinal Deformity: Prevalence and Impact on Spine Surgery Outcomes.

BACKGROUND: Hip osteoarthritis (OA) is common in patients with adult spinal deformity (ASD). Limited data exist on the prevalence of hip OA in patients with ASD, or on its impact on baseline and postoperative alignment and patient-reported outcome measures (PROMs). Therefore, this paper will assess the prevalence and impact of hip OA on alignment and PROMs. METHODS: Patients with ASD who underwent L1-pelvis or longer fusions were included. Two independent reviewers graded hip OA with the Kellgren-Lawrence (KL) classification and stratified it by severity into non-severe (KL grade 1 or 2) and severe (KL grade 3 or 4). Radiographic parameters and PROMs were compared among 3 patient groups: Hip-Spine (hip KL grade 3 or 4 bilaterally), Unilateral (UL)-Hip (hip KL grade 3 or 4 unilaterally), or Spine (hip KL grade 1 or 2 bilaterally). RESULTS: Of 520 patients with ASD who met inclusion criteria for an OA prevalence analysis, 34% (177 of 520) had severe bilateral hip OA and unilateral or bilateral hip arthroplasty had been performed in 8.7% (45 of 520). A subset of 165 patients had all data components and were examined: 68 Hip-Spine, 32 UL-Hip, and 65 Spine. Hip-Spine patients were older (67.9 ± 9.5 years, versus 59.6 ± 10.1 years for Spine and 65.8 ± 7.5 years for UL-Hip; p < 0.001) and had a higher frailty index (4.3 ± 2.6, versus 2.7 ± 2.0 for UL-Hip and 2.9 ± 2.0 for Spine; p < 0.001). At 1 year, the groups had similar lumbar lordosis, yet the Hip-Spine patients had a worse sagittal vertebral axis (SVA) measurement (45.9 ± 45.5 mm, versus 25.1 ± 37.1 mm for UL-Hip and 19.0 ± 39.3 mm for Spine; p = 0.001). Hip-Spine patients also had worse Veterans RAND-12 Physical Component Summary scores at baseline (25.7 ± 9.3, versus 28.7 ± 9.8 for UL-Hip and 31.3 ± 10.5 for Spine; p = 0.005) and 1 year postoperatively (34.5 ± 11.4, versus 40.3 ± 10.4 for UL-Hip and 40.1 ± 10.9 for Spine; p = 0.006). CONCLUSIONS: This study of operatively treated ASD revealed that 1 in 3 patients had severe hip OA bilaterally. Such patients with severe bilateral hip OA had worse baseline SVA and PROMs that persisted 1 year following ASD surgery, despite correction of lordosis. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Changes in experienced quality of oncological cancer care during the COVID-19 pandemic based on patient reported outcomes - a cross-sectional study.

AIM: The study aims to investigate the impact of the COVID-19 pandemic on cancer patients' perceptions of the quality of their oncological treatment and care. BACKGROUND: The COVID-19 pandemic disrupted healthcare delivery and oncological resources were repurposed, potentially leading to prolonged treatment and reduced access to innovative therapies and clinical trials. Still, little is known about how patients perceived the quality of their treatment. METHODS: A cross-sectional study was conducted in the spring of 2020 among cancer patients at the Department of Oncology, Aarhus University Hospital and Rigshospitalet, Denmark. Patients were invited to complete an online questionnaire on clinical, socioeconomic, emotional, behavioural, and quality-related aspects of oncological cancer care. Patients who experienced reduced treatment quality and those who reported no or slight reductions were compared using multiple logistic regression, exploring the associations with patient characteristics, behaviours, and fear of cancer progression or recurrence. RESULTS: A total of 2,040/5,372 patients experienced changes in their treatment plans during the pandemic, and 1,570/5,372 patients experienced reduced treatment quality, with 236 reporting a high degree of reduction. Patients with breast, head and neck, and upper gastrointestinal cancers were more likely to experience reduced treatment quality. Altered interactions with healthcare providers, along with isolation, lack of social support, and heightened fear of cancer progression, were significant risk factors for experiencing reduced cancer care quality. INTERPRETATION: We identified subgroups of cancer patients needing targeted communication and care during health crises affecting cancer treatment. The findings underscore the importance of safeguarding the needs of vulnerable patient populations in future healthcare emergencies.

Measurement properties of the Portuguese version of the rheumatoid arthritis patient-reported experience measure (CQRA-PREM): a cross-sectional single center study.

AIMS: to test the measurement properties of the Portuguese version of the Commissioning for Quality in Rheumatoid Arthritis Patient-Reported Experience Measure (CQRA-PREM) for patients with rheumatoid arthritis (RA). METHODS: This cross-sectional clinical field study recruited adult patients with RA during rheumatology appointments of a Portuguese rheumatology center. Patients completed the Portuguese version of CQRA-PREM, composed of 7 domains and 24 questions. Sociodemographic characteristics, symptoms/disease duration, current treatment, Pain-Visual Analog Scale (VAS), Patient Global Assessment (PGA)-VAS and Health Assessment Questionnaire (HAQ) were also collected from the patient. Disease Activity Score for 28 joints with C-reactive Protein (DAS28-CRP) was recorded by the rheumatologist. The assessment of CQRA-PREM measurement properties followed the Consensus-based Standards for the Selection of Health Status Measurement Instruments (COSMIN) recommendations. RESULTS: A total of 61 patients with RA were included. The domains in which patients showed better experience were the "Needs and preferences", followed by "Coordination and Communication". The domain "Information, education and self-care" was an identified area of improvement for providing patient-centered care. Ceiling effects were found in four domains of the CQRA-PREM. Internal consistency of all domains was considered good (α>0.7). Homogeneity was considered good for each question in all domains analyzed (0.30≤rp≤0.70). The divergent validity of the PREM was good, revealing that the domains were not correlated (Pain-VAS, HAQ, DAS28-CRP) or only weakly (PGA-VAS) correlated with clinical outcomes. CONCLUSIONS: The CQRA-PREM showed acceptable measurement properties and is a useful tool for evaluating quality of healthcare provided in daily practice, as perceived by RA patients in Portugal.

Evaluating patient-reported adherence and outcomes in specialty disease states: A dual-site initiative.

BACKGROUND: Patient-reported outcomes (PROs) are often used by clinicians to evaluate patient response to specialty medications used to treat multiple sclerosis (MS) and rheumatologic conditions. Identifying associations among PROs and patient characteristics could inform patient-centered treatment monitoring. OBJECTIVE: To examine the association among patient characteristics and PROs, including patient-reported adherence (defined as no missed doses), medication tolerance, patient perceived effectiveness, and health care resource utilization (HCRU; defined as emergency department visits or hospitalizations), for patients prescribed specialty medications in 2 health system specialty pharmacies. METHODS: A dual-center, retrospective review of monthly medication assessments completed by Vanderbilt Specialty Pharmacy and University of Illinois Hospital and Health Sciences System specialty pharmacy was conducted. Patients were included if they received at least 3 fills of a specialty medication from rheumatology or MS clinics from October 2019 to March 2022, excluding patients with more than a 30-day supply. Primary outcomes were the PROs of patient-reported adherence, medication tolerability, perceived effectiveness, and HCRU. For each of the 2 primary outcomes (adherence and tolerability), a mixed-effects logistic regression model was used to test for associations with age, sex, race, clinic, site, and the other PROs. RESULTS: A total of 61,926 assessments were completed from 3,677 patients (Site 1 = 3,346; 91.0% and Site 2 = 331; 9.0%). Patients were predominantly White (75.6%) and female (71.7%) with a median age of 50 years (IQR = 37-61). Assessments most frequently originated from rheumatology (76.0%). Nonadherence was reported 4.0% of the time, with the most common explanations being forgetfulness (33.1%) and medication being held because of a procedure or illness (29.5%). Most responses indicated perceived effectiveness as good/excellent (93.9%), with 98.5% of responses indicating no issues with tolerability. Patients who reported tolerability issues were 2.5 times more likely to report a missed dose (95% CI = 1.87-3.23, P < 0.001). An effectiveness rating of fair was associated with a 61% increase in the odds of a missed dose compared with a rating of good/excellent (95% CI = 1.33-1.94). CONCLUSIONS: Patients filling rheumatology or MS specialty medications within health system specialty pharmacies reported high rates of medication effectiveness and adherence and low rates of issues with tolerability and HCRU. Patients who report tolerability issues or lower perceived effectiveness may benefit from additional monitoring to prevent nonadherence.

Helping ourselves, helping others: the Young Women's Breast Cancer Study (YWS) - a multisite prospective cohort study to advance the understanding of breast cancer diagnosed in women aged 40 years and younger.

PURPOSE: Compared with older women diagnosed with breast cancer, younger women are more likely to die of breast cancer and more likely to suffer psychosocially in both the short-term and long term. The Young Women's Breast Cancer Study (YWS) is a multisite prospective cohort study established to address gaps in our knowledge about this vulnerable and understudied population. PARTICIPANTS: The YWS enrolled 1302 women newly diagnosed with stages 0-IV breast cancer at age 40 years or younger at 13 academic and community sites in North America between 2006 and 2016. Longitudinal patient-reported outcome data are complemented by clinical data abstraction and biospecimen collection at multiple timepoints. FINDINGS TO DATE: Key findings related to fertility include that nearly 40% of participants were interested in pregnancy following diagnosis; of those who reported interest, 10% pursued fertility preservation. Overall, approximately 10% of YWS participants became pregnant in the first 5 years after diagnosis; follow-up is ongoing for pregnancies after 5 years. Studies focused on psychosocial outcomes have characterised quality of life, post-traumatic stress and fear of recurrence, with findings detailing the factors associated with the substantial psychosocial burden many young women face during and following active treatment. Multiple studies have leveraged YWS biospecimens, including whole-exome sequencing of tumour analyses that revealed that select somatic alterations occur at different frequencies in young (age≤35) versus older women with luminal A breast cancer, and a study that explored clonal hematopoiesis of indeterminate potential found it to be rare in young survivors. FUTURE PLANS: With a median follow-up of approximately 10 years, the cohort is just maturing for many relevant long-term outcomes and provides outstanding opportunities to further study and build collaborations to address gaps in our knowledge, with the ultimate objective to improve care and outcomes for young women with breast cancer. TRIAL REGISTRATION NUMBER: NCT01468246.

A mixed methods evaluation of patient perspectives on the implementation of an electronic health record-integrated patient-reported symptom and needs monitoring program in cancer care.

BACKGROUND: As cancer centers have increased focus on patient-centered, evidenced-based care, implementing efficient programs that facilitate effective patient-clinician communication remains critical. We implemented an electronic health record-integrated patient-reported symptom and needs monitoring program ('cPRO' for cancer patient-reported outcomes). To aid evaluation of cPRO implementation, we asked patients receiving care in one of three geographical regions of an academic healthcare system about their experiences. METHODS: Using a sequential mixed-methods approach, we collected feedback in two waves. Wave 1 included virtual focus groups and interviews with patients who had completed cPRO. In Wave 2, we administered a structured survey to systematically examine Wave 1 themes. All participants had a diagnosed malignancy and received at least 2 invitations to complete cPRO. We used rapid and traditional qualitative methods to analyze Wave 1 data and focused on identifying facilitators and barriers to cPRO implementation. Wave 2 data were analyzed descriptively. RESULTS: Participants (n = 180) were on average 62.9 years old; were majority female, White, non-Hispanic, and married; and represented various cancer types and phases of treatment. Wave 1 participants (n = 37) identified facilitators, including cPRO's perceived value and favorable usability, and barriers, including confusion about cPRO's purpose and various considerations for responding. High levels of clinician engagement with, and patient education on, cPRO were described as facilitators while low levels were described as barriers. Wave 2 (n = 143) data demonstrated high endorsement rates of cPRO's usability on domains such as navigability (91.6%), comprehensibility (98.7%), and relevance (82.4%). Wave 2 data also indicated low rates of understanding cPRO's purpose (56.7%), education from care teams about cPRO (22.5%), and discussing results of cPRO with care teams (16.3%). CONCLUSIONS: While patients reported high value and ease of use when completing cPRO, they also reported areas of confusion, emphasizing the importance of patient education on the purpose and use of cPRO and clinician engagement to sustain participation. These results guided successful implementation changes and will inform future improvements.

Highly extensile approach for comminuted ulna coronoid process fractures with mini-plate fixation: a case series of 31 patients.

BACKGROUND: For the treatment of coronoid process fractures, medial, lateral, anterior, anteromedial, and posterior approaches have been increasingly reported; however, there is no general consensus on the method of fixation of coronal fractures. Here, we present a highly-extensile minimally invasive approach to treat coronoid process fractures using a mini-plate that can achieve anatomic reduction, stable fixation, and anterior capsular repair. Further, the study aimed to determine the complication rate of the anterior minimally invasive approach and to evaluate functional and clinical patient-reported outcomes during follow-up. METHODS: Thirty-one patients diagnosed with coronoid fractures accompanied with a "terrible triad" or posteromedial rotational instability between April 2012 and October 2018 were included in the analysis. Anatomical reduction and mini-plate fixation of coronoid fractures were performed using an anterior minimally invasive approach. Patient-reported outcomes were evaluated using the Mayo Elbow Performance Index (MEPI) score, range of motion (ROM), and the visual analog score (VAS). The time of fracture healing and complications were recorded. RESULTS: The mean follow-up time was 26.7 months (range, 14-60 months). The average time to radiological union was 3.6 ± 1.3 months. During the follow-up period, the average elbow extension was 6.8 ± 2.9° while the average flexion was 129.6 ± 4.6°. According to Morrey's criteria, 26 (81%) elbows achieved a normal desired ROM. At the last follow-up, the mean MEPI score was 98 ± 3.3 points. There were no instances of elbow instability, elbow joint stiffness, subluxation or dislocation, infection, blood vessel complications, or nerve palsy. Overall, 10 elbows (31%) experienced heterotopic ossification. CONCLUSION: An anterior minimally invasive approach allows satisfactory fixation of coronoid fractures while reducing incision complications due to over-dissection of soft tissue injuries. In addition, this incision does not compromise the soft tissue stability of the elbow joint and allows the patient a more rapid return to rehabilitation exercises.

Measuring health related quality of life (HRQoL) in Lysosomal Storage Disorders (LSDs): a rapid scoping review of available tools and domains.

BACKGROUND: Lysosomal storage diseases (LSDs) are a group of rare inherited metabolic disorders, consisting of over 70 diseases that are characterised by lysosomal dysfunction. Due to their varied and progressive symptoms, LSDs have a continual impact on patients' health-related quality of life (HRQoL). Several recently published studies have provided insight into the HRQoL of individuals with LSDs. However, it is challenging to meaningfully synthesise this evidence, since studies often focus upon a particular type of LSD and / or utilise different self-report questionnaires or patient-reported outcome measures (PROMs) to assess HRQoL. AIMS: The aim of this study was to review the published literature in LSDs, to identify the PROMs which have been used to assess HRQoL and generate a conceptual map of HRQoL domains measured in individuals diagnosed with LSDs. METHODS: Three electronic databases were searched in March 2022. Primary studies of any design which utilised multi-item PROMs to assess at least one aspect of HRQoL in individuals with LSDs since 2017 were identified. Data were extracted to assess both the characteristics of each study and of the PROMs utilised within each study. The extraction of HRQoL domains and synthesis were informed by an a priori framework, inductively modified to reflect data emerging from the identified literature. Selection and extraction was undertaken independently by two reviewers; discrepancies were ratified by a third reviewer. RESULTS: Sixty nine studies were identified which were published 2017-2022, with a combined total of 52 PROMs (71 variants) used to assess HRQoL in individuals with LSDs. The final extracted HRQoL framework included 7 domains (Activities; Physical sensations; Autonomy; Cognition; Feelings and emotions; Self-identity; Relationships), characterised by 37 sub-domains. CONCLUSIONS: This review highlights the breadth and variety of HRQoL domains assessed in individuals with LSDs, across three broad domains of physical, psychological and social functioning. The resultant framework and mapped PROMs will aid researchers and clinicians in the selection of PROMs to assess aspects of HRQoL in people living with LSDs, based on their conceptual coverage.

Patient-reported physical well-being predicts good long-term survival of hematopoietic stem cell transplantation.

AIM: This study aimed to explore the association between patient-reported items at different time points after hematopoietic stem cell transplantation (HSCT) and long-term survival. METHODS: We conducted a study with 144 allogeneic HSCT patients, following them for 5 years post-transplantation. Data from the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) questionnaire were collected before transplantation and at 1, 3, 6, 12, 18, 36, and 60 months after transplantation. Demographic characteristics and survival status were also assessed. RESULTS: Among the 144 cases, the 5-year overall survival (OS), progression-free survival (PFS), non-relapse mortality (NRM), and graft-versus-host disease-free (GRFS) rates were 65%, 48%, 17%, and 36% respectively. Health-related quality of life (HRQOL) showed a fluctuating pattern over 5 years. Using a latent class mixed model, patients were classified into two groups based on their physical well-being (PWB) scores during the 60-month follow-up. Class 1 had initially lower PWB scores, which gradually increased over time. In contrast, Class 2 maintained higher PWB scores with slight increases over time. Kaplan-Meier survival analysis revealed that Class 1 had better OS (70.9% vs. 52.9%, p = 0.021), PFS (60.5% vs. 41.2%, p = 0.039), and GRFS (35.1% vs. 29.3%, p = 0.035) compared to Class 2. CONCLUSIONS: Patients who had higher initial PWB scores after HSCT demonstrated improved long-term survival outcomes. The PWB score could serve as a valuable predictor for the prognosis of HSCT.

Are all cancer survivors included when using electronically administered patient reported outcomes in primary healthcare cancer rehabilitation? A cross-sectional study.

BACKGROUND: Patient reported outcomes (PROs) are being used frequently in clinical practice. PROs often serve several purposes, such as increasing patient involvement, assessing health status, and monitoring and improving the quality-of-care at an aggregated level. However, the lack of representative PRO-data may have implications for all these purposes. This study aims to assess the association of non-administration of (not sending an electronic invite to PRO) and non-response to (not responding to PRO) electronically administered PROs with social inequality in a primary healthcare cancer rehabilitation setting. Furthermore, it examines whether the workflows surrounding PRO have an impact on non-administration and non-response. METHODS: This is a cross sectional study using routinely collected data from electronic health records and registers including cancer survivors (CSs) over 18 years booked for an initial consultation in a primary healthcare cancer rehabilitation setting using PROs for systematic health status assessment. During the study period two different PRO platforms were used, each associated with different workflows. Non-administration and non-response rates were calculated for sociodemographic characteristics for each PRO platform. Crude and adjusted odds ratios were calculated using univariate and multivariate logistic regression. RESULTS: In total, 1868 (platform 1) and 1446 (platform 2) CSCSs were booked for an initial consultation. Of these, 233 (12.5%) (platform 1) and 283 (19.6%) (platform 2) were not sent a PRO (non-administration). Among those who received a PRO, 157 (9.6%) on platform 1 and 140 (12.0%) on platform 2 did not respond (non-response). Non-administration of and non-response to PROs were significantly associated with lower socioeconomic status. Moreover, the workflows surrounding PROs seem to have an impact on non-inclusion in and non-response to PROs. CONCLUSIONS: Non-administration of and non-response to PROs in clinical practice is associated with determinants of social inequality. Clinical workflows and the PRO platforms used may potentially worsen this inequality. It is important to consider these implications when using PROs at both the individual and aggregated levels. A key aspect of implementing PROs in clinical practice is the ongoing focus on representativeness, including a focus on monitoring PRO administration and response.

Developing a fit-for-purpose composite symptom score as a symptom burden endpoint for clinical trials in patients with malignant pleural mesothelioma.

We developed a composite symptom score (CSS) representing disease-related symptom burden over time in patients with malignant pleural mesothelioma (MPM). Longitudinal data were collected from an open-label Phase IIB study in which 239 patients completed the validated MD Anderson Symptom Inventory for MPM (MDASI-MPM). A blinded, independent review committee of external patient-reported outcomes experts advised on MDASI-MPM symptoms to include in the CSS. Through iterative analyses of potential symptom-item combinations, 5 MPM symptoms (pain, fatigue, shortness of breath, muscle weakness, coughing) were selected. The CSS correlated strongly with the full MDASI-MPM symptom set (0.92-0.94) and the Lung Cancer Symptom Scale-Mesothelioma (0.79-0.87) at each co-administration of the scales. The CSS also had good sensitivity to worsening disease and global quality-of-life ratings. The MDASI-MPM CSS can be used as an outcome in MPM clinical trials, including in responder analyses and at the individual patient level. It is brief enough to administer frequently, including electronically, to better capture symptom trajectories during and after a trial and in clinical practice. As a single score, the CSS addresses multiplicity issues that can arise when several symptoms increase due to worsening disease. Our process can be adapted to produce a CSS for other advanced-cancer trials.

Measurement properties of the EQ-5D-Y-3L, PedsQL 4.0, and PROMIS-25 Profile v2.0 in pediatric patients with spinal muscular atrophy.

OBJECTIVE: The objective of this study was to examine the psychometric properties of the EQ-5D-Y-3 L, Patient Reported Outcomes Measurement System 25-item version profile v2.0 (PROMIS-25), and Pediatric Quality of Life Inventory™ version 4.0 Generic Core Scale (PedsQL 4.0) in Chinese pediatric patients with spinal muscular atrophy (SMA). METHODS: The data used in this study were obtained via a web-based cross-sectional survey. Parents of pediatric patients with SMA completed the proxy-reported EQ-5D-Y-3 L, PedsQL 4.0, and PROMIS-25 measures. Information about socioeconomic and health status was also obtained. The ceiling and floor effects, factorial structure, convergent validity, and known-group validity of the three measures were assessed. RESULTS: Three hundred and sixty-three parents of children aged from 5 to 12 completed the questionnaires. Strong floor effects were observed for the physical function components of the PROMIS-25 (41.3%) and PedsQL 4.0 (67.8%). For EQ-5D-Y-3 L, 84.6% of the respondents reported having "a lot of" problems with the dimensions "walking" and "looking after myself." Minimal ceiling or floor effects were observed for the EQ-5D-Y-3 L index value. The confirmatory factor analysis supported a six-factor structure for the PROMIS-25, but did not support a four-factor structure for the PedsQL 4.0. All hypothesized correlations of the dimensions among the three measures were confirmed, with coefficients ranging from 0.28 to 0.68. Analysis of variance showed that EQ-5D-Y-3 L demonstrated better known-group validity than the other two measures in 14 out of 16 comparisons. CONCLUSIONS: The EQ-5D-Y-3 L showed better discriminant power than the other two measures. The physical health dimensions of all three measures showed the significant floor effects. These findings provide valuable insights into the effectiveness of these measures at capturing and quantifying the impact of SMA on patients' health-related quality of life.

Design, implementation and usability analysis of patient empowerment in ADLIFE project via patient reported outcome measures and shared decision making.

INTRODUCTION: This paper outlines the design, implementation, and usability study results of the patient empowerment process for chronic disease management, using Patient Reported Outcome Measurements and Shared Decision-Making Processes. BACKGROUND: The ADLIFE project aims to develop innovative, digital health solutions to support personalized, integrated care for patients with severe long-term conditions such as Chronic Obstructive Pulmonary Disease, and/or Chronic Heart Failure. Successful long-term management of patients with chronic conditions requires active patient self-management and a proactive involvement of patients in their healthcare and treatment. This calls for a patient-provider partnership within an integrated system of collaborative care, supporting self-management, shared-decision making, collection of patient reported outcome measures, education, and follow-up. METHODS: ADLIFE follows an outcome-based and patient-centered approach where PROMs represent an especially valuable tool to evaluate the outcomes of the care delivered. We have selected 11 standardized PROMs for evaluating the most recent patients' clinical context, enabling the decision-making process, and personalized care planning. The ADLIFE project implements the "SHARE approach' for enabling shared decision-making via two digital platforms for healthcare professionals and patients. We have successfully integrated PROMs and shared decision-making processes into our digital toolbox, based on an international interoperability standard, namely HL7 FHIR. A usability study was conducted with 3 clinical sites with 20 users in total to gather feedback and to subsequently prioritize updates to the ADLIFE toolbox. RESULTS: User satisfaction is measured in the QUIS7 questionnaire on a 9-point scale in the following aspects: overall reaction, screen, terminology and tool feedback, learning, multimedia, training material and system capabilities. With all the average scores above 6 in all categories, most respondents have a positive reaction to the ADLIFE PEP platform and find it easy to use. We have identified shortcomings and have prioritized updates to the platform before clinical pilot studies are initiated. CONCLUSIONS: Having finalized design, implementation, and pre-deployment usability studies, and updated the tool based on further feedback, our patient empowerment mechanisms enabled via PROMs and shared decision-making processes are ready to be piloted in clinal settings. Clinical studies will be conducted based at six healthcare settings across Spain, UK, Germany, Denmark, and Israel.

Patient-Reported Outcome Measures in Routine Clinical Practice: Practical Guidance for Institutional Review Boards.

The use of patient-reported outcome measures (PROMs) is increasingly common in routine clinical practice. As tools to quantify symptoms and health status, PROMs play an important role in focusing health care on outcomes that matter to patients. The uses of PROM data are myriad, ranging from clinical care to survey-based research and quality improvement. Discerning the boundaries between these use cases can be challenging for institutional review boards (IRBs). In this article, we provide a framework for classifying the three primary PROM use cases (clinical care, human subjects research, and quality improvement) and discuss the level of IRB oversight (if any) necessary for each. One of the most important considerations for IRB staff is whether PROMs are being used primarily for clinical care and thus do not constitute human subjects research. We discuss characteristics of PROMs implemented primarily for clinical care, focusing on: data platform; survey location; questionnaire length; patient interface; and clinician interface. We also discuss IRB oversight of projects involving the secondary use of PROM data that were collected during the course of clinical care, which span human subjects research and quality improvement. This framework provides practical guidance for IRB staff as well as clinicians who use PROMs as communication aids in routine clinical practice.

Redisplacement of reduced distal radius fractures in adults: does the type of casting play a role? The CAST study, a multicentre cluster randomized controlled trial.

Aims: It is not clear which type of casting provides the best initial treatment in adults with a distal radial fracture. Given that between 32% and 64% of adequately reduced fractures redisplace during immobilization in a cast, preventing redisplacement and a disabling malunion or secondary surgery is an aim of treatment. In this study, we investigated whether circumferential casting leads to fewer the redisplacement of fewer fractures and better one-year outcomes compared with plaster splinting. Methods: In a pragmatic, open-label, multicentre, two-period cluster-randomized superiority trial, we compared these two types of casting. Recruitment took place in ten hospitals. Eligible patients aged ≥ 18 years with a displaced distal radial fracture, which was acceptably aligned after closed reduction, were included. The primary outcome measure was the rate of redisplacement within five weeks of immobilization. Secondary outcomes were the rate of complaints relating to the cast, clinical outcomes at three months, patient-reported outcome measures (PROMs) (using the numerical rating scale (NRS), the abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH), and Patient-Rated Wrist/Hand Evaluation (PRWHE) scores), and adverse events such as the development of compartment syndrome during one year of follow-up. We used multivariable mixed-effects logistic regression for the analysis of the primary outcome measure. Results: The study included 420 patients. There was no significant difference between the rate of redisplacement of the fracture between the groups: 47% (n = 88) for those treated with a plaster splint and 49% (n = 90) for those treated with a circumferential cast (odds ratio 1.05 (95% confidence interval (CI) 0.65 to 1.70); p = 0.854). Patients treated in a plaster splint reported significantly more pain than those treated with a circumferential cast, during the first week of treatment (estimated mean NRS 4.7 (95% CI 4.3 to 5.1) vs 4.1 (95% CI 3.7 to 4.4); p = 0.014). The rate of complaints relating to the cast, clinical outcomes and PROMs did not differ significantly between the groups (p > 0.05). Compartment syndrome did not occur. Conclusion: Circumferential casting did not result in a significantly different rate of redisplacement of the fracture compared with the use of a plaster splint. There were comparable outcomes in both groups.

Cross-Cultural Validation of the RECAP of Atopic Eczema Question-naire in a Swedish Population.

A Swedish translation of the patient-reported outcome measure for assessing long-term control of atopic dermatitis, Recap of atopic eczema (RECAP), has not been validated. Cross-cultural translation and multi-centre validation of the translated RECAP questionnaire were therefore performed. Disease severity was assessed using the validated Investigator Global Assessment Scale for atopic dermatitis (vIGA-ADTM). The Swedish RECAP was completed by 208 individuals aged 16 years or older with a median age of 36 years (interquartile range [IQR] 27-48). The participants considered the questionnaire suitable for assessing eczema control. The median RECAP score (range 0-28) was 12 (IQR 5-19). The mean and median vIGA-ADTM scores (range 0-4) were 2 (standard deviation [SD] 2) and 3 (IQR 2-4), respectively. A correlation between RECAP and the vIGA-ADTM was observed (p < 0.001). There was no significant change in scores for participants who answered the questionnaire twice within 14 days. Over time, improved or worsened eczema, as evaluat-ed by vIGA-ADTM, affected RECAP scores significantly (p < 0.001). The study suggests that RECAP can assess AD control in a Swedish clinical setting and shows -acceptable reliability.

Long-term Outcomes of Multiligament Knee Injuries in American Football Players.

BACKGROUND: Long-term outcomes for isolated anterior cruciate ligament (ACL) reconstructions in competitive American football athletes are well reported in the literature, but little data currently exist regarding multiligament knee injury (MLKI) reconstruction outcomes. PURPOSE: To examine patient-reported and return-to-sport outcomes of competitive American football athletes who underwent primary, single-staged, multiligament knee reconstruction. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: We identified patients from our institution's prospectively collected data repository between 2001 and 2020 who underwent single-staged surgical reconstruction of an MLKI sustained during competitive participation in American football. We assessed patient-reported outcomes at a minimum of 2 years after surgery using the International Knee Documentation Committee (IKDC) Subjective Knee Form and questions regarding surgical satisfaction and return to sport. Successful return to sport was defined as a return to preinjury level of competition. We summarized all outcome data and compared outcomes between 2-ligament and >2-ligament groups and between ACL-only MLKI injury and bicruciate MLKI injury groups using independent t test for IKDC scores and chi-square test for return to sport. Additionally, we evaluated predictors of postoperative IKDC scores using linear regression and predictors of return to sport using logistic regression. RESULTS: Outcome data were successfully collected for 53 of 73 total eligible patients (73%; mean follow-up time, 7.7 ± 4.0 years; all male; mean age at surgery, 18.1 ± 2.7 years). The mean postoperative IKDC score was 84 ± 16. The most common level of preinjury competition was high school (n = 36; 68%), followed by college (n = 10; 19%). Seven patients did not return to sport competition at any level due to limitations from their knee surgery, and 82% of patients that attempted to return to preinjury level of sport were able to do so. A total of 50 patients (94%) were satisfied or very satisfied with their surgical outcome. The 2-ligament (n = 39) and >2-ligament (n = 14) groups did not significantly differ in IKDC scores (P = .96) or proportions with successful return to sport (P = .77). Similarly, the ACL-MLKI injury (n = 39) and bicruciate MLKI injury (n = 14) groups did not significantly differ in IKDC scores (P = .89) or proportions with successful return to sport (P = .77). Age and body mass index were not significantly associated with IKDC scores or successful return to sport at follow-up (all P > .05). CONCLUSION: This study may represent the largest cohort of competitive American football athletes evaluated for longitudinal outcomes after multiligament knee reconstruction. Despite the severity of these injuries, we found good knee-related function and that the large majority of athletes who attempted to return to sport were successful. The majority of athletes (94%) were satisfied with their operative treatment.