Longitudinal assessment of health-related quality of life in Japanese patients with advanced urothelial carcinoma receiving immune check point inhibitors.

Real-world data on health-related quality of life (HRQoL) in advanced urothelial carcinoma (aUC) receiving immune checkpoint inhibitors (ICIs) are limited. This study included 42 patients with aUC who received second-line or later pembrolizumab (n = 19), maintenance avelumab followed by first-line chemotherapy (n = 13), or adjuvant nivolumab after radical surgery (n = 10). Time-course changes in the domains and scales related to HRQoL were evaluated using the EORTC QLQ-C30, FACT-G, and SF-8 questionnaires during ICI therapy. Anchor-based approaches for minimally important differences were determined as 'improved', 'stable', and 'deteriorated'. We found significant improvements after the start of pembrolizumab treatment on many scales. Almost none of the scales changed significantly in the avelumab and nivolumab groups. Approximately 80% of the pembrolizumab group had deteriorated social/family well-being in FACT-G. Approximately 60% of the patients in the avelumab group had deteriorated general health and vitality in SF-8. In the nivolumab group, none of the scales deteriorated in > 50% of the patients. Deterioration of physical function in the SF-8 was associated with occurrence of treatment-related adverse events ≥ grade 2 during ICI therapy (P = 0.013). Our findings demonstrated that majority of patients with aUC who received ICI therapy had a stable HRQoL, which was consistent with evidence from clinical trials.

Reporting of patient-reported outcomes amongst randomized clinical trials in plastic surgery: a systematic review using CONSORT-PRO.

BACKGROUND: Patient-reported outcomes (PROs) are key to investigating patient perspectives in randomized controlled trials (RCTs). Standardization of PRO reporting is critical for trial generalizability and the application of findings to clinical practice. This systematic review aimed to evaluate the reporting quality of RCTs published in the top plastic surgery journals according to the consolidated standards of reporting trials (CONSORT)-PRO extension. METHODS: We completed a comprehensive search of MEDLINE, Embase, and Cochrane Central Register of Controlled Trials. All RCTs with a validated PRO endpoint published in the top 10 plastic surgery journals (based on the 2021 Web of Science Impact Factor) from 2014 to 2023 were included. Two reviewers independently extracted data and scored the included studies using the CONSORT-PRO checklist. Univariate regression was applied to assess factors associated with reporting adherence. Studies were assessed for their risk of bias using the Cochrane Risk of Bias 2.0 tool. RESULTS: A total of 88 RCTs were included. PROs were the primary endpoint in 50 (57%) and the secondary endpoint of 38 (43%) studies. Mean overall reporting adherence was poor (39% (±12) and 36% (±13) in studies with PRO as primary and secondary endpoints, respectively). The presence of industry support was significantly associated with greater adherence. CONCLUSIONS: There is low adherence to the CONSORT-PRO extension among plastic surgery RCTs published in the top 10 plastic surgery journals. We encourage journals and authors to endorse and apply the CONSORT-PRO extension. This may optimize the dissemination of clinical findings from RCTs and assist patient-centered care.

Forefoot inflammation in recent-onset ACPA-positive and ACPA-negative RA: clinically similar, but different in underlying inflamed tissues.

OBJECTIVES: Although joint swelling is traditionally interpreted as synovitis, recent imaging studies showed that there is also inflammation of tenosynovium and intermetatarsal bursae in the forefoot. We aimed to increase our understanding of differences and similarities regarding forefoot involvement between ACPA-positive and ACPA-negative rheumatoid arthritis (RA) at diagnosis. Therefore, we (1) compared metatarsophalangeal (MTP) joint counts, walking disabilities and inflamed tissues between ACPA groups and (2) studied associations of joint swelling/tenderness and walking disabilities with underlying inflamed tissues within ACPA groups. METHODS: 171 ACPA-positive and 203 ACPA-negative consecutively diagnosed patients with RA had a physical joint examination (swollen joint count-66/tender joint count-68), filled a Health Assessment Questionnaire including the domain walking and underwent MRI of the MTP joints at diagnosis. Synovitis, tenosynovitis, osteitis and intermetatarsal bursitis (IMB) were assessed. Findings in age-matched healthy controls were applied to define abnormalities on MRI. RESULTS: While ACPA-negative RA patients had more swollen joints (mean SJC 8 vs 6 in ACPA-positives, p=0.003), the number of swollen MTP joints was similar (mean 1 in both groups); walking disabilities were also equally common (49% vs 53%). In contrast, inflamed tissues were all more prevalent in ACPA-positive compared with ACPA-negative RA. Within ACPA-positive RA, IMB was associated independently with MTP-joint swelling (OR 2.6, 95% CI 1.4 to 5.0) and tenderness (OR 3.0, 95% CI 1.8 to 5.0). While in ACPA-negatives, synovitis was associated independently with MTP-joint swelling (OR 2.8, 95% CI 1.4 to 5.8) and tenderness (OR 2.5, 95% CI 1.3 to 4.8). Tenosynovitis contributed most to walking disabilities. CONCLUSIONS: Although the forefoot of ACPA-positives and ACPA-negatives share clinical similarities at diagnosis, there are differences in underlying inflamed tissues. This reinforces that ACPA-positive and ACPA-negative RA are different entities.

Development of a web-based ecological momentary assessment tool to measure day-to-day variability of the symptoms in patients with Sjögren's disease.

OBJECTIVES: To develop and validate a web-based ecological momentary assessment (EMA) tool to enhance symptoms monitoring among patients with Sjögren's disease (SjD). METHODS: Consecutive adults with SjD were enrolled in this pilot observational study. Participants used the WebApp over a 3-month period, for the daily collection of individual EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) scales and separate assessment of eyes and mouth dryness, using 0-10 numerical scales. Primary outcome was the measure of the interdaily variability of symptoms. Data collected through the WebApp were compared with those obtained with paper-based questionnaires administered during a final visit, using distinct approaches (predicted error, maximum negative error and maximum positive error). User experience was assessed using the System Usability Scale (SUS) score. RESULTS: Among the 45 participants, 41 (91.1%) were women. Median age was 57 years (IQR: 49-66). Daily variability of symptoms ranged between 0.5 and 0.8 points across the scales. Over the 3-month period, the predicted error ranged between -1.2 and -0.3 points of the numerical scales. The greatest differences were found for fatigue (-1.2 points (IQR: -2.3 to -0.2)) and ESSPRI score (-1.2 points (IQR: -1.7 to -0.3)). Over the last 2 weeks, the predicted error ranged between - 1.2 and 0.0 points. Maximum negative error ranged between -2.0 and -1.0 points, and maximum positive error between -0.3 and 0.0 points. Median SUS score was 90 (IQR: 85-95). CONCLUSION: Our results demonstrate the usability and the relevance of our web-based EMA tool for capturing data that closely reflects daily experiences of patients with SjD.

Implementing a Streamlined Hypoglossal Nerve Stimulator Pathway: Cost, Time to Surgery, and Outcomes.

Objective: To evaluate the costs, time to surgery, and clinical outcomes associated with implementing a streamlined hypoglossal nerve stimulator (HGNS) implantation pathway. Study Design: Retrospective cohort study. Setting: Single tertiary care center in the United States from 2016 to 2023. Methods: Patients with a lack of complete concentric collapse of the velum during volitional snore on in-office laryngoscopy qualified for the streamlined HGNS pathway. This pathway consisted of confirmatory drug-induced sleep endoscopy (DISE) followed immediately by HGNS implantation during the same surgical encounter. Outcomes were compared to patients in the traditional pathway (standalone DISE followed by HGNS implantation on a later date). Results: A total of 68 patients (13 streamlined, 55 traditional) with obstructive sleep apnea who underwent HGNS implantation were included. Patients were predominately male (70.6%) and White (95.6%) and had a mean (SD) age of 63.5 (10.0) years. The streamlined pathway was associated with a significant reduction in both hospital costs (mean difference $9258, 95% confidence interval [CI]: 3690-14,825; P = .002) and time to surgery (mean decrease of 3.82 months, 95% CI: 0.83-6.80 months; P = .013) compared to the traditional pathway. Patients in both groups had reduction in apnea-hypopnea index and Epworth Sleepiness Scale score, with no significant differences in comparisons between groups. Conclusion: In select patients, the streamlined HGNS pathway may expedite time to surgery and reduce hospital costs with comparable clinical outcomes to a traditional 2-stage pathway. Further research is warranted to validate patient selection and better understand longitudinal outcomes.

Truth and dare: patients dare to tell the truth when using PROMs in clinical practice.

PURPOSE: As patient-reported outcome measures (PROMs) are increasingly used in clinical practice for screening, monitoring, and management, the potential for response bias has been raised (e.g., over-reporting problems for attention, under-reporting to avoid treatment changes/discontinuation). We investigated whether patients systematically bias their responses when they know clinicians will review their PROM results. METHODS: We conducted secondary analyses of three experimental studies evaluating PROMs in adult and pediatric care. Prior to PROM completion, intervention group patients were informed that the results would be shown to their clinicians ("feedback" arm), whereas control group patients were told that their clinicians would not see their responses ("no feedback" arm). Independent sample t-tests compared the "feedback" and "no feedback" arms' PROM scores at baseline. Effect sizes and 95% confidence intervals were estimated using Cohen's d statistics with Hedges' g correction, and effect sizes > 0.50 were considered clinically relevant. RESULTS: Across the 29 domains assessed in the three studies, no between-arm differences reached an effect size of ± 0.50. Only 3/29 effect sizes exceeded ± 0.30. The confidence intervals for 14 domains included ± 0.50, with 4 favoring the "no feedback" arm and 10 favoring the "feedback" arm. Two domains reached statistical significance, one favoring the "no feedback" arm and one favoring the "feedback" arm. CONCLUSION: This study does not support the hypothesis that patients systematically bias their PROM responses if they know that clinicians will see their results. These findings support using PROMs in clinical practice as a valid mechanism to promote patient-centered care.

Positive experiences with the use of an eHealth smartphone application during the treatment of an abdominal aortic aneurysm.

OBJECTIVE: To evaluate the patient perceived satisfaction and feasibility of a personalized eHealth application (app) for abdominal aortic aneurysm (AAA) patients undergoing surgery. METHODS: Patients were offered to download the app prior to undergoing AAA surgery, in a prospective single centre cohort study, using a mixed methods sequential explanatory design. It offers information via the timely delivery of push notifications with text, images, and videos. The information includes chapters regarding the AAA, surgical techniques (endovascular aneurysm repair and open surgical repair), and perioperative lifestyle advice such as; physical exercise programmes, healthy and protein rich diet, geriatric care, and to stop smoking or drinking alcohol. RESULTS: The app was installed by 59/65 patients (91%). After installation, six patients deactivated the app (10%). The mean age was 74 years (SD = 7) and 85% of patients were male. The app was opened a median of 67 times (interquartile range [IQR] 33-127) and with a median time interval of 50 hours (IQR 28-74). Overall, 90% (53/59) completed a satisfaction questionnaire. On a numeric rating scale from 0 to 10, the median scored satisfaction for guidance was 8 (IQR 6-8), provided information was 8 (IQR 6-8), usefulness was 7 (IQR 6-8.5), and for recommending it to others 8 (IQR 6-9). Using purposeful sampling, seven patients underwent a semi-structured interview on user-experience of the app. They described experiencing positive changes to lifestyle habits, and appreciating the ability to share it with loved ones or informal caregivers. Several areas of improvement were reported. CONCLUSION: The personalized eHealth app is feasible in older AAA patients and valued as a useful supplement to the standard of care. We argue that the app aids in managing a prehabilitation programme, aids in the digital transformation of healthcare, and thereby decreases the workload of hospital staff.

Health-related Quality of Life Assessment in Renal Cell Cancer: A Scoping Review.

BACKGROUND AND OBJECTIVE: In oncology, patient-reported outcome measures (PROMs) capturing health-related quality of life (HRQOL) play an increasing role in clinical trials, drug approval, and policy making. This scoping review aimed to identify and elaborate on HRQOL-focussed PROMs used in renal cell cancer (RCC) clinical trials. METHODS: MEDLINE, Web of Science, PsychINFO, Academic Search Elite, CINAHL, Embase, and the Cochrane Library were searched systematically for original peer-reviewed articles on clinical trials including RCC patients and using PROMs, published between 1950 and 2023. Prespecified trial characteristics and information on the PROMs used were extracted. Frequencies and proportions of categorical data, and ranges and medians of continuous variables were calculated. KEY FINDINGS AND LIMITATIONS: Of the 48 unique studies included, the majority followed a randomised controlled design (34, 71%) and evaluated systemic treatments (38, 79%). The trials used 27 different PROMs (max = 6, median = 2), of which only 4 (15%) were developed specifically for kidney cancer patients. Of the trials, 46% did not use any RCC-specific PROM. European Quality of Life-5 Dimensions (EQ-5D), European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI) -15/19-item version, FKSI-Disease Related Symptoms, and Functional Assessment of Cancer Therapy-General (FACT-G) were the most frequently used questionnaires, with pain, ability to work, fatigue, worry, and sleep quality being the most commonly assessed issues. CONCLUSIONS AND CLINICAL IMPLICATIONS: A variety of PROMs are used in RCC patients, hindering interpretability across trials. The PROMs used differ in terms of both the domains assessed and how the issues are translated into questionnaire items. Though RCC-specific PROMs exist, these have flaws in terms of relevance to patients. To answer predefined relevant HRQOL research questions, revised RCC-specific PROMs and standardisation of their integration into clinical trials are warranted. PATIENT SUMMARY: Researchers are more and more interested in the health-related quality of life of kidney cancer patients and use questionnaires to measure it. This review shows that there are many different health-related quality of life questionnaires that are used in different combinations in clinical trials for kidney cancer patients. This makes it very difficult to compare these study results and draw reliable conclusions for the actual clinical treatment. It was even found that some of the questionnaires used do not capture things that patients actually consider important (eg, emotional issues such as dealing with thoughts about cancer and depression). Therefore, more work needs to be done to develop questionnaires that ask what is really important to kidney cancer patients' health-related quality of life. If these questionnaires are used in a consistent way in clinical trials, the results can be better compared. This will help treat kidney cancer patients in the best possible way.

Meaningful patient and public engagement in dissemination-embedding co-production in dementia research.

Background: Patient and Public Involvement and Engagement (PPIE) is still underutilised in both dementia research and corresponding dissemination activities. Aim: To describe the methods, format, and lessons learned in co-creating and co-producing a dissemination strategy for a research project focused on establishing patient-centred outcome measures into routine palliative community care for persons living with dementia (PLWD) and their informal carers. Materials and methods: A participatory, hybrid-format workshop was conducted to co-create the dissemination strategy with a PPIE group. A video presentation of findings and a list of prompts shared prior to the workshop were used to elicit views on dissemination strategies and knowledge translation. The workshop was followed up with a survey to consolidate the dissemination strategy. Workshop minutes and survey responses were analysed using qualitative thematic analysis. Results: 22 participants from our diverse PPIE group attended the workshop. Two major themes emerged: (a) Knowledge translation: building bridges between research and practise, and (b) Collaboration and dissemination: everyone's voice is needed. Participants suggested critical changes to dissemination methods and materials. Successful knowledge translation depends on a strong evidence base. For this, materials need to be tailored to specific audiences. Everyone's voice needs to be integrated through co-production in dissemination activities by PPIE members to influence societal change. Tailored dissemination activities within a dissemination strategy were co-created spanning all phases of the research cycle. Discussion: Informing and educating the public and policymakers about the needs of PLWD relies on disseminating and fostering knowledge translation throughout all phases of the research cycle.

Categories of the Patient-Specific Functional Scale Activities in Chronic Neck Pain and Their Relationship to the Neck Disability Index.

Intoduction: Common outcome measures for chronic neck pain are the Patient-Specific Functional Scale (PSFS) and the neck disability index (NDI). The primary aim was to categorize the top-rated, patient-selected functional activity limitations of the PSFS to determine if there were consistent limited functional activities for individuals with chronic neck pain and how these compared to the constructs of activities on the NDI. The secondary aim was to determine the relationship between scores for individuals who completed both the NDI and PSFS. Design: A retrospective review of data extracted from the electronic medical record, EPIC, within two hospital-based outpatient physical therapy clinics within a health care system. Methods: Retrospective analysis was performed on individual's characteristics, self-selected functional activity limitations, and total scores of the PSFS and NDI. Most common categories of self-selected functional activity limitations were developed by practicing physical therapists. These functional activity limitation categories of the PSFS were compared to the activities of the NDI. Mean PSFS total scores were correlated with the NDI total scores with Spearman's test. Results: Participants were individuals with chronic neck pain from January 2013-September 2018 (n = 2283). Movement-based activities accounted for 60.8% of the functional activity limitations of the PSFS with the top functional activity limitations being cervical motion and exercise (32%). The PSFS total score moderately correlated with NDI (r = -0.50, p = <0.01) which may relate to the differences in constructs of the NDI and the top patient-selected PSFS functional activity limitations found in this analysis. Conclusion: The results suggest that individuals with chronic neck pain present with similar categories of self-selected functional activity limitations that differ from activities of the NDI. Additional research is needed to improve outcome measures to capture patient-selected functional activity limitations and an individual's pain experience.

Quality of life and psychological distress in end-stage renal disease patients undergoing hemodialysis and transplantation.

BACKGROUND: Among diverse profound impacts on patients' quality of life (QoL), end-stage renal disease (ESRD) frequently results in increased levels of depression, anxiety, and stress. Renal replacement therapies such as hemodialysis (HD) and transplantation (TX) are intended to enhance QoL, although their ability to alleviate psychological distress remains uncertain. This research posits the existence of a significant correlation between negative emotional states and QoL among ESRD patients, with varying effects observed in HD and TX patients. AIM: To examine the relationship between QoL and negative emotional states (depression, anxiety, and stress) and predicted QoL in various end-stage renal replacement therapy patients with ESRD. METHODS: This cross-sectional study included HD or TX patients in the Eastern Region of Saudi Arabia. The 36-item Short Form Survey and Depression Anxiety Stress Scale (DASS) was used for data collection, and correlation and regression analyses were performed. RESULTS: The HD and TX transplantation groups showed statistically significant inverse relationships between QoL and DASS scores. HD patients with high anxiety levels and less education scored low on the physical component summary (PCS). In addition, the results of the mental component summary (MCS) were associated with reduced depression. Compared with older transplant patients, TX patients' PCS scores were lower, and depression, stress, and negative working conditions were highly correlated with MCS scores. CONCLUSION: The findings of this study revealed notable connections between well-being and mental turmoil experienced by individuals undergoing HD and TX. The PCS of HD patients is affected by heightened levels of anxiety and lower educational attainment, while the MCS of transplant patients is influenced by advancing age and elevated stress levels. These insights will contribute to a more comprehensive understanding of patient support.

Validated patient reported outcome measures in speech-language pathology: A scoping review of adult practice.

PURPOSE: Patient reported outcome measures (PROMs) are increasingly used to inform value-based healthcare. Within speech-language pathology (SLP), there is no synthesis of validated PROMs to guide professional practice. This scoping review systematically identifies and evaluates condition-specific PROMs across adult SLP practice. METHOD: A literature search was performed to identify studies published until 18th February 2022 from MEDLINE, Embase, CINAHL, PsycInfo, Scopus, Cochrane Collaboration, and Web of Science. Abstracts and full texts were screened in Covidence. Relevant studies that validated PROMs in English were extracted and assessed using the "Checklist to operationalise measurement characteristics of PROMs" by two independent reviewers. RESULT: Ninety-seven articles provided validation data for 71 PROMS across seven SLP practice areas. These included voice (n = 18), swallowing (n = 14), language (n = 11), fluency (n = 8), speech (n = 4), laryngectomy (n = 3), and cognitive-communication (n = 2). No PROMs were identified for augmentative and alternative communication (AAC) (n = 0). Quality ratings were variable on the Francis et al. checklist. CONCLUSION: A range of validated PROMs were identified to guide SLP practice in measuring patient perceptions across a range of practice areas in adults. Opportunities for further development in SLP practice areas with limited PROMs, such as speech, cognitive-communication, and AAC are also highlighted.

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.

Clinical trials involving rare gynaecological cancers.

Clinical trials that investigate therapies for rare gynaecological cancers (RGC) are essential to provide evidence-based data towards new effective and safe treatments, however, they present unique challenges. The main objective of this narrative review is to summarize completed phase III clinical trials investigating therapies for RGC and to discuss the outcomes of these trials. PRISMA guidelines were used to report the steps of the review. We searched the WHO's International Clinical Trials Registry Platform, clinicaltrials.gov and PubMed/Medline for publications reporting results from clinical trials on RGC including at least one medication. From 31 identified phase III clinical trials, 13 were still ongoing, four were terminated and just eight (25.8 %) had posted results and/or publications. The latter completed trials were mostly multi-center and located in at least two continents, participants were mainly adults, and the recruitment period varied from about 2.5 to 10.5 years. Allocation was randomized with parallel assignment in 7 out of 8 trials, while only one trial had double masking. The most common primary outcome measure was progression-free survival (PFS), followed by overall survival (OS). Patient-reported outcomes were secondary outcome measures in four completed trials, assessing quality of life by various questionnaires. Most of the trials did not meet their primary endpoints. By highlighting the scarcity of clinical trials on RGC, our findings further emphasize the need for designing, conducting and sustaining phase III clinical trials to investigate innovative therapies for these conditions and report meaningful outcome measures.

Patient-Reported Outcome Measures for Pelvic Organ Prolapse: A Systematic Review Using the COnsensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) Checklist.

BACKGROUND: Patient-reported outcome measures (PROMs) are recommended to measure the impact of a health condition or intervention effectiveness as they aim to capture what is most meaningful to patients. Several PROMs are used to evaluate pelvic organ prolapse (POP)-related domains, yet the measurement properties of these instruments have not been fully explored with a rigorous analysis of the methodological quality and quality of evidence. OBJECTIVE: To conduct a systematic review reporting on the measurement properties of PROMs used for the assessment of POP-related domains in accordance with the COSMIN guidelines. SEARCH STRATEGY: Five databases were searched from inception to December 2023. SELECTION CRITERIA: Studies were eligible if they involved (1) at least one group of female adults diagnosed with or presenting with symptoms of POP; (2) a self-reported outcome measure (PROMs, questionnaires) to evaluate POP-related domains; and (3) at least one measurement property. DATA COLLECTION AND ANALYSIS: Methodological quality and measurement quality were assessed using the COSMIN risk of bias (ROB) checklist and the COSMIN criteria for good measurement properties. MAIN RESULTS: A total of 13 PROMs were included. The BIPOP had the lowest ROB for Content Validity. The POP-SS was the only PROM with sufficient evidence of adequate construct validity and responsiveness to be used in both surgical and conservative management settings. CONCLUSION: This original work identified a gap in evidence regarding the measurement qualities of identified PROMs used in the POP population.

Comparison of a Single Assessment Numeric Evaluation Method and the Banff Patella Instability Instrument 2.0 for Patients With Patellofemoral Instability.

Background: The concept of Single Assessment Numeric Evaluation (SANE) has been introduced for several clinical entities; however, a validated SANE focusing on patients with patellofemoral instability has not been described. Purpose/Hypothesis: The purpose of this study was to investigate the expressiveness of SANE questions (SQs) for the assessment of patients experiencing patellofemoral instability. It was hypothesized that the complexity of patellofemoral instability cannot be demonstrated by a single question. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: Between October 2022 and March 2023, 120 consecutive patients (male/female, 50/70; mean age, 23.9 ± 8.0 years; mean body mass index, 25.3 ± 5.1 kg/m2) with patellofemoral instability were assessed with the Banff Patella Instability Instrument 2.0 (BPII 2.0). Patients were randomized into 3 groups (40 patients each) and asked to answer 1 of 3 SQs: "How do you rate your knee joint if a completely stable kneecap means 100%?" (SQ 1), "How do you rate your knee joint if complete satisfaction means 100%?" (SQ 2), and "How do you rate your knee joint if complete normal function means 100%?" (SQ 3). Means ± standard deviations were compared using 1-way analysis of variance, the correlation between BPII 2.0 and each SQ was assessed by Pearson correlation, and Bland-Altmann analysis was performed to investigate biases of each SQ in comparison with BPII 2.0. Results: The mean BPII 2.0 score was 40.5 ± 16.8 points, and the mean results of SQ 1, SQ 2, and SQ 3 were 44.2% ± 26.0%, 42.6% ± 25.4%, and 44.2% ± 18.9%, respectively, without significant differences between the groups (all P > .05). The correlations between BPII 2.0 and SQ 1, SQ 2, and SQ 3 were high (r = 0.75; 95% CI, 0.58 to 0.86; P < .0001), low (r = 0.35; 95% CI, -0.05 to 0.6; P = .02), and low (r = 0.31; 95% CI, -0.002 to 0.56; P = .051), respectively. Bland-Altman analysis between BPII 2.0 and SQ 1, SQ 2, and SQ 3 revealed biases of -0.12 (SD, 17.1), -1.45 (SD, 24.4), and -8.0 (SD, 19.4), respectively. Conclusion: The SQ "How do you rate your knee joint if a completely stable kneecap means 100%?" demonstrated concurrent validity with the BPII 2.0 and may serve as a helpful tool to quickly assess patients with recurrent patellofemoral instability in a preoperative setting.

Revisiting abdominal wall "morbidity" of the extensile anterolateral approach to the thoracolumbar spine.

PURPOSE: To assess patients' perceptions of their abdominal wall following extensile anterolateral approaches to the thoracolumbar spine for adult spinal deformity (ASD) using validated questionnaires. METHODS: Adults who underwent anterior-posterior thoracolumbar spinal operations to the pelvis for ASD in which the anterior fusion was performed through an extensile anterolateral approach were reviewed. Three questionnaires were administered at least 1 year following surgery and included The Abdominal Core Health Quality Collaborative Survey (AHS-QC), The Patient Scar Assessment Scale (PSAS), and The Anterior Abdominal Incision Questionnaire (AAIQ). RESULTS: Fifty-one patients (80.4% female, median age 65 years) were included. Average follow-up was 2.8 ± 1.7 years. Average number of anterior fusion levels was 3.5 ± 1.4. Patients achieved high satisfaction rates from surgery (74.5%). AAIQ responses included postoperative pain (33.3%), bulging (41.7%), and limitations in daily activities (18.8%) with only 15.7% experienced moderate-severe pain related to their incisions and only 6.3% seeking treatment for their scars. Post-operatively, 63.2% had a neutral or improved self-image of their torso and trunk, while only 10.2% stating it was much worse. Patients' overall opinion of their scar compared to their normal skin was very positive [average 2.75 ± 2.93 (10 = worst possible scar)]. Favorable scores were also reported for color difference, stiffness, change in thickness, and irregularity in their abdominal scar compared to normal skin. CONCLUSIONS: Following extensile anterolateral approaches to the thoracolumbar spine for ASD, the majority of patients reported mild pain, mild functional limitations, good cosmesis, and high satisfaction rates with their anterior incisions based on validated questionnaires.

mHealth Physical Activity and Patient-Reported Outcomes in Patients With Inflammatory Bowel Diseases: Cluster Analysis.

BACKGROUND: Regular physical activity is associated with improved quality of life in patients with inflammatory bowel diseases (IBDs), although much of the existing research is based on self-reported data. Wearable devices provide objective data on many rich physical activity dimensions including steps, duration, distance, and intensity. Little is known about how patients with IBDs engage in these varying dimensions of exercise and how it may influence their symptom and disease-specific patient-reported outcomes (PROs). OBJECTIVE: This study aims to (1) cluster physical activity patterns from consumer-grade wearable devices and (2) assess the relationship between the clusters and PROs in patients with IBDs. METHODS: We conducted a cross-sectional and longitudinal cohort study among adults with IBDs in the Crohn's and Colitis Foundation IBD Partners cohort. Participants contribute physical activity data through smartphone apps or wearable devices in a bring-your-own-device model. Participants also complete biannual PRO questionnaires from the Patient-Reported Outcomes Measurement Information System short forms and IBD-specific questionnaires. K-means cluster analysis was used to generate physical activity clusters based on 3 key features: number of steps, duration of moderate to vigorous activity (minutes), and distance of activity (miles). Based on the clusters, we conducted a cross-sectional analysis to examine differences in mean questionnaire scores and participant characteristics using one-way ANOVA and chi-square tests. We also conducted a longitudinal analysis to examine individual cluster transitions among participants who completed multiple questionnaires, and mean differences in questionnaire scores were compared using 2-tailed paired sample t tests across 6-month periods. RESULTS: Among 430 participants comprising 1255 six-week physical activity periods, we identified clusters of low (33.7%, n=423), moderate (46%, n=577), and high (20.3%, n=255) physical activity. Scores varied across clusters for depression (P=.004), pain interference (P<.001), fatigue (P<.001), sleep disturbance (P<.001), social satisfaction (P<.001), and short Crohn Disease Activity Index (P<.001), with those in the low activity cluster having the worst scores. Sociodemographic characteristics also differed, and those with low physical activity were older (P=.002), had higher BMIs (P<.001), and had longer disease durations (P=.02) compared to other clusters. Among 246 participants who completed at least 2 consecutive questionnaires consisting of 726 questionnaire periods, 67.8% (n=492) remained in the same cluster, and only 1.2% (n=9) moved to or from the furthest clusters of low and high activity across 6-month periods. CONCLUSIONS: For patients with IBDs, there were positive associations between physical activity and PROs related to disease activity and psychosocial domains. Physical activity patterns mostly did not fluctuate over time, suggesting little variation in exercise levels in the absence of an intervention. The use of real-world data to identify subgroups with similar lifestyle behaviors could be leveraged to develop targeted interventions that provide support for psychosocial symptoms and physical activity for personalized IBD care.

English Translation and Cultural Adaptation of the Knee Numeric-Entity Evaluation Score (KNEES-ACL): A Condition-Specific Patient-Reported Outcome Measure for Anterior Cruciate Ligament Injuries.

BACKGROUND: The Knee Numeric-Entity Evaluation Score (KNEES-ACL) is a 41-item condition-specific patient-reported outcome measure (PROM) that was developed for patients with an anterior cruciate ligament (ACL) deficiency and patients after ACL reconstruction. This measure is intended to be used for longitudinal clinical studies. The KNEES-ACL has demonstrated face and content validity and superior responsiveness compared with other PROMs commonly used in patients with an ACL injury. However, this PROM was developed in Danish and has not been appropriately translated and culturally adapted into North American English. PURPOSE: To translate and culturally adapt the KNEES-ACL from Danish to North American English. STUDY DESIGN: Cross-sectional study. METHODS: Translation from Danish to English and cultural adaptation to a North American context were performed according to the dual panel method. First, the Danish KNEES-ACL was translated by a bilingual panel, which provided multiple English wording options for each item. Second, an English lay panel focus group was formed to determine the wording for each item that best reflected everyday spoken language. Finally, individual think-aloud cognitive interviews were conducted with patients after an ACL injury to evaluate the relevance, comprehensiveness, and comprehensibility of the PROM content and questions. Repeated modifications and testing were performed until a final English version of the KNEES-ACL was constructed. RESULTS: Participants in the lay panel focus group were able to reach unanimous decisions for each of the 41 items. Further changes to 17 items were made after 8 think-aloud interviews with patients with ACL injuries at various time points to ensure that items were relevant and being interpreted consistently among different types of patients. The final KNEES-ACL consisted of 6 domains: Problems with Daily Activities, Mental Impact, Stability, Strength and Control, Pain, and Sport and Physical Activity. CONCLUSION: The English KNEES-ACL for patients with ACL injuries has undergone appropriate translation and cultural adaptation using established dual panel and cognitive interviewing methods in the population of interest. The psychometric properties of the English KNEES-ACL will likely mirror those established with the Danish version. However, direct validation of the psychometric properties of the English version would be beneficial before widespread use.

"Numbers call for action, personalized narratives provide support and recognition": a qualitative assessment of cancer patients' perspectives on patient-reported outcome measures (PROMs) feedback with narratives.

PURPOSE: Patient-reported outcome measures (PROMs) are questionnaires completed by patients to gain insight in their health-related quality of life. However, patients often find the interpretation of PROMS challenging. A personalized narrative, i.e., a story with patients' experiences tailored to the reader, could help explain PROMs and might be appreciated alongside numerical outcomes. We studied how cancer patients perceive PROMs feedback presented in a regular numerical and a novel narrative format. METHODS: Cancer patients who completed PROMs in routine clinical practice were recruited. All participants received numerical feedback and a personalized narrative. Semi-structured interviews were conducted to uncover perceptions of both formats. Interviews were analyzed with an inductive reflexive approach to thematic analysis. RESULTS: Twenty-nine patients with breast cancer, melanoma, and bladder cancer participated. Thematic analysis identified six themes: "Understanding: I get the gist of it!"; "Usefulness: Tell me why I should complete PROMs"; "Format preferences: Numbers are cold, narratives are warm"; "Taking action: Can I do something about my score?"; "Personal relevance: Personalized narratives show me what life has in store for me"; and "Personal relevance: That's (not) me!" Numbers seemed to help participants act, whereas narratives may provide emotional support and recognition. Participants identified with the content of the narrative yet differed in how they related to the main character. CONCLUSION: Personalized narratives could be a useful addition to PROMs feedback. The studied formats seem to serve different purposes; numbers help to facilitate action, personalized narratives provide recognition. IMPLICATIONS FOR CANCER SURVIVORS: Personalized narratives may be a useful new way to communicate about quality of life to cancer survivors and help them to envision what the impact of cancer can be.