Pooled analysis of NeoCARH and NeoCART trials: patient-reported outcomes in patients with early-stage breast cancer receiving platinum-based or anthracycline-based neoadjuvant chemotherapy.

PURPOSE: Anthracycline-based or platinum-based neoadjuvant chemotherapy belongs to the standard treatment for early-stage breast cancer (EBC) that is either triple-negative or human epidermal growth factor receptor 2 positive (HER2 +). Currently, there is a paucity of data comparing their impact on health-related quality of life (HRQoL). METHODS: Triple-negative or HER2 + EBC from our two prospective randomized controlled trials, neoCARH and neoCART, were divided into two groups based on the neoadjuvant chemotherapy regimens they received: anthracycline-based or platinum-based group. HRQoL was the exploratory endpoint in these two trials, which was assessed using the European Organization for Research and Treatment of Cancer Quality of Life-Core30 and Breast23 questionnaires. The primary variable of interest was the C30 summary score (C30-SumSc). Assessments were carried out at baseline, after neoadjuvant chemotherapy, and 1 year and 2 years after diagnosis. RESULTS: The mean questionnaires' compliance rate was 95.0%. After neoadjuvant chemotherapy, 210 patients had evaluable HRQoL data, the mean least square change from baseline for the platinum-based group was - 15.997 (95% confidence interval (CI): - 17.877 to - 14.117), and it was - 20.156 (95% CI: - 22.053 to - 18.258) for the anthracycline-based group (difference: 4.159, 95% CI: 1.462 to 6.855, P = 0.003, minimal important difference = 3). For the majority of the domains of interest assessed by the C30 and BR23 questionnaires, the platinum-based group demonstrated superior outcomes in comparison to the anthracycline-based group. CONCLUSION: Patients receiving platinum-based or anthracycline-based regimens both experienced worsened HRQoL after neoadjuvant chemotherapy; however, the former provided relatively better HRQoL compared with the latter. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT03140553. Registered 4 May 2017 (neoCARH). NCT03154749. Registered 16 May 2017 (neoCART).

Patient-Reported Outcomes in Phase 3 Clinical Trials for Blood Cancers: A Systematic Review.

Importance: Published research suggests that patient-reported outcomes (PROs) are neither commonly collected nor reported in randomized clinical trials (RCTs) for solid tumors. Little is known about these practices in RCTs for hematological malignant neoplasms. Objective: To evaluate the prevalence of PROs as prespecified end points in RCTs of hematological malignant neoplasms, and to assess reporting of PROs in associated trial publications. Evidence Review: All issues of 8 journals known for publishing high-impact RCTs (NEJM, Lancet, Lancet Hematology, Lancet Oncology, Journal of Clinical Oncology, Blood, JAMA, and JAMA Oncology) between January 1, 2018, and December 13, 2022, were searched for primary publications of therapeutic phase 3 trials for adults with hematological malignant neoplasms. Studies that evaluated pretransplant conditioning regimens, graft-vs-host disease treatment, or radiotherapy as experimental treatment were excluded. Data regarding trial characteristics and PROs were extracted from manuscripts and trial protocols. Univariable analyses assessed associations between trial characteristics and PRO collection or reporting. Findings: Ninety RCTs were eligible for analysis. PROs were an end point in 66 (73%) trials: in 1 trial (1%) as a primary end point, in 50 (56%) as a secondary end point, and in 15 (17%) as an exploratory end point. PRO data were reported in 26 of 66 primary publications (39%): outcomes were unchanged in 18 and improved in 8, with none reporting worse PROs with experimental treatment. Trials sponsored by for-profit entities were more likely to include PROs as an end point (49 of 55 [89%] vs 17 of 35 [49%]; P < .001) but were not significantly more likely to report PRO data (20 of 49 [41%] vs 6 of 17 [35%]; P = .69). Compared with trials involving lymphoma (18 of 29 [62%]) or leukemia or myelodysplastic syndrome (18 of 28 [64%]), those involving plasma cell disorders or multiple myeloma (27 of 30 [90%]) or myeloproliferative neoplasms (3 of 3 [100%]) were more likely to include PROs as an end point (P = .03). Similarly, compared with trials involving lymphoma (3 of 18 [17%]) or leukemia or myelodysplastic syndrome (5 of 18 [28%]), those involving plasma cell disorders or multiple myeloma (16 of 27 [59%]) or myeloproliferative neoplasms (2 of 3 [67%]) were more likely to report PROs in the primary publication (P = .01). Conclusions and Relevance: In this systematic review, almost 3 of every 4 therapeutic RCTs for blood cancers collected PRO data; however, only 1 RCT included PROs as a primary end point. Moreover, most did not report resulting PRO data in the primary publication and when reported, PROs were either better or unchanged, raising concern for publication bias. This analysis suggests a critical gap in dissemination of data on the lived experiences of patients enrolled in RCTs for hematological malignant neoplasms.

The Ottawa clinical fear of recurrence instruments: A screener, self-report, and clinical interview.

OBJECTIVE: Clinical fear of cancer recurrence (FCR) was recently defined by a group of experts during a Delphi study. Five criteria were agreed upon, namely: (a) high levels of preoccupation, (b) high levels of worry, (c) that are persistent, (d) hypervigilance and hypersensitivity to physical sensations that e) may result in functional impairment. No existing instruments comprehensively capture all these criteria for clinical FCR. METHODS: To remedy this gap, a set of three patient-reported outcome instruments including a one-item screener, self-report questionnaire, and semi-structured clinical interview, named the Ottawa Clinical Fear of Recurrence instruments, were developed. To do so, the research team first conducted a literature review of potential items. Additional FCR experts discussed the content of the screener and interview. The self-report's items were assessed for content validity by the same expert panel using Likert ratings and the Content Validity Index to narrow down the number of items. The three instruments were piloted with a group of cancer survivors to assess face validity following the European Organization for Research and Treatment of Cancer recommendations. RESULTS: The literature review and content validity assessment led to a final draft pre-pilot of 23 potential items for the self-report questionnaire. The instruments were piloted. Pilot study participants suggested changing wording and response options (particularly for the self-report) for greater clarity. CONCLUSIONS: Based on the feedback received, minor modifications were made, mostly for the self-report. In general, content and face validity for the three instruments were good for both experts and cancer survivors.

Medial malleolar osteotomy in the treatment of osteochondral lesions of the Talus - incidence and impact on functional outcome: a retrospective analysis based on data from the German Cartilage Register (KnorpelRegister DGOU).

BACKGROUND: There has long been discussion regarding the impact of medial malleolar osteotomies (MMO) as an adjunctive treatment for osteochondral lesions of the talus (OCLT). MMO may improve the visibility and accessibility of the talus, but they also pose a risk of periprocedural morbidity. There is a lack of research about the prevalence and consequences of MMO in the surgical treatment of OCLT. METHODS: This study retrospectively evaluated data from the German Cartilage Register (KnorpelRegister DGOU) from its implementation in 2015 to December 2020. The impact of MMO on patient-reported outcome measures (PROMs) was investigated. Wherever possible, subgroups were built and matched using a propensity score which matched a group undergoing OCLT without MMO. Matching included age, sex, weight, localization of the OCLT, the international cartilage repair society (ICRS) grading, surgical procedure and preoperative symptoms using the Foot and Ankle Ability Measure (FAAM) and the Activities of Daily Living Subscale (ADL). RESULTS: The prevalence of MMO in the operative treatment of OCLT was 15.9%. Most of the osteotomies were performed in OCL of the medial talar dome (76.8%) and in more serious lesions with an ICRS grade of III (29.1%) and IV (61.4%). More than half of the osteotomies (55.6%) were performed during revision surgery. A matched pair analysis of n = 44 patients who underwent AMIC® via arthrotomy and MMO vs. arthrotomy alone showed no significant differences in patient-reported outcome measures (PROMs, i.e. FAAM-ADL, and FAOS) at 6,12 and 24 months. CONCLUSIONS: MMO are mostly used in the treatment of severe (≥ ICRS grade 3) OCL of the medial talar dome and in revision surgery. Functional and patient-reported outcome measures are not significantly affected by MMO compared to arthrotomy alone. TRIAL REGISTRATION: The German Cartilage Register (KnorpelRegister DGOU) was initially registered at the German Clinical Trials Register ( https://www.drks.de , register number DRKS00005617, Date of registration 03.01.2014) and was later expanded by the ankle module.

Linking patient-reported oral and general health-related quality of life.

Background: The relationship between oral and overall health is of interest to health care professionals and patients alike. This study investigated the correlation between oral health-related quality of life (OHRQoL) and health-related quality of life (HRQoL) in a general adult population. Methods: This cross-sectional study used a convenience sample of adult participants (N = 607) attending the 2022 Minnesota County and State fairs in USA, the 5-item Oral Health Impact Profile (OHIP-5) assessed OHRQoL, and the 10-item PROMIS v.1.2 Global Health Instrument assessed HRQoL. Spearman and Pearson correlations were used to summarize the bivariable relationship between OHRQoL and HRQoL (both physical and mental health dimensions). A structural equation model determined OHRQoL-HRQoL correlations (r). Correlations' magnitude was interpreted according to Cohen's guidelines (r = 0.10, 0.30, and 0.50 to demarcate "small," "medium," and "large" effects, respectively). Results: OHRQoL and HRQoL correlated with r = 0.52 (95% confidence interval, CI: [0.50-0.55]), indicating that the two constructs shared 27% of their information. According to Cohen, this was a "large" effect. OHRQoL, and the physical and mental HRQoL dimensions correlated with r = 0.55 (95% CI: [0.50-0.59]) and r = 0.43 (95% CI: [0.40-0.46]), respectively, indicating a "large" and a "medium" effect. OHRQoL and HRQoL were substantially correlated in an adult population. Conclusion: Using OHIP-5 to assess their dental patients' oral health impact allows dental professionals to gain insights into patients' overall health-related wellbeing.

Breast Reduction with Implants or Augmentation Reduction: Patient-Reported Outcomes from a Single-Centre Retrospective Cohort Analysis.

Background and Objectives: The correction of breast hypertrophy and ptosis with implant placement has always posed a challenge for plastic surgeons. Various methods have been devised, yielding conflicting results. The purpose of this study is to describe our surgical technique of breast reduction with silicone implants, present the safety profile of the procedure, and report patient-reported outcomes. Materials and Methods: A retrospective review was performed on our case series of cosmetic breast surgery performed by the senior author between October 2020 and November 2023. Only patients who had over 300 g of breast tissue removed were included. The surgery and demographic characteristics were recorded. Patients were asked to complete a questionnaire about satisfaction with their breasts pre-operatively and after the surgery. Results: Over 745 cases were performed, and 25 were included in the analysis. In total, 78.3% of the patients presented with a Grade 3 ptosis. The mean implant size was 352.39 cc (range 300-455 cc). The breast tissue removed ranged from 312 to 657 g. The mean follow-up was 14.17 months. Only one case required revision surgery after developing capsular contracture and a waterfall deformity. Patients reported a statistically significant improvement across all domains of the questionnaire (p < 0.001). Conclusions: Breast reduction plus implants is a safe and effective alternative for patients with large ptotic breasts who wish to attain a full upper pole. It carries a similar risk profile to augmentation mastopexy and maintains its functional benefits in alleviating back, neck, and shoulder pain.

Analysis of outcome reporting in sciatic neuropathy studies: a systematic review of the literature.

PURPOSE: As a first step towards developing a core outcome set (COS) for sciatic neuropathy, the goal of the current study was to perform a systematic review of the literature to identify outcome measures that have been previously reported in studies on sciatic neuropathy. METHODS: A systematic review of the literature from 2000-2024 was performed utilizing PubMed and Medical Subject Headings (MeSH). Identified articles were screened according to study inclusion/exclusion criteria. Outcome measures reported in each included study were recorded and categorized into motor, sensory, pain, patient-reported outcomes, electrodiagnostic outcomes, imaging outcomes, and composite outcomes. Descriptive statistics were performed. RESULTS: A total of 1586 articles were initially identified, and 31 articles met criteria for inclusion and underwent analysis. The most common outcome domain was pain. A pain outcome was reported in 17 (63%) studies. A motor outcome was reported in 10 (37%) studies; 6 (22%) reported a sensory outcome; 1 (4%) reported a composite outcome; 4 (15%) reported an electrodiagnostic outcome; 5 (19%) reported a patient-reported outcome; 3 (11%) reported an imaging outcome. Across the included studies, 21 unique outcomes were reported. CONCLUSIONS: We have identified the outcome measures that have previously been utilized in studies on sciatic neuropathy. Previously used outcome measures fell into seven domains: motor outcomes, sensory outcomes, pain outcomes, patient-reported outcomes, electrodiagnostic outcomes, imaging outcomes, and composite outcomes. Pain outcomes were most commonly used across the included studies.

Morning light treatment for inflammatory bowel disease: a clinical trial.

BACKGROUND: Inflammatory bowel disease (IBD) affects over 3 million Americans and has a relapsing and remitting course with up to 30% of patients experiencing exacerbations each year despite the availability of immune targeted therapies. An urgent need exists to develop adjunctive treatment approaches to better manage IBD symptoms and disease activity. Circadian disruption is associated with increased disease activity and may be an important modifiable treatment target for IBD. Morning light treatment, which advances and stabilizes circadian timing, may have the potential to improve IBD symptoms and disease activity, but no studies have explored these potential therapeutic benefits in IBD. Therefore, in this study, we aim to test the effectiveness of morning light treatment for patients with IBD. METHODS: We will recruit sixty-eight individuals with biopsy-proven IBD and clinical symptoms and randomize them to 4-weeks of morning light treatment or 4-weeks of treatment as usual (TAU), with equivalent study contact. Patient-reported outcomes (IBD-related quality of life, mood, sleep), clinician-rated disease severity, and a biomarker of gastrointestinal inflammation (fecal calprotectin) will be assessed before and after treatment. Our primary objective will be to test the effect of morning light treatment versus TAU on IBD-related quality of life and our secondary objectives will be to test the effects on clinician-rated disease activity, depression, and sleep quality. We will also explore the effect of morning light treatment versus TAU on a biomarker of gastrointestinal inflammation (fecal calprotectin), and the potential moderating effects of steroid use, restless leg syndrome, and biological sex. DISCUSSION: Morning light treatment may be an acceptable, feasible, and effective adjunctive treatment for individuals with active IBD suffering from impaired health-related quality of life. TRIAL REGISTRATION: The study protocol was registered on ClinicalTrials.gov as NCT06094608 on October 23, 2023, before recruitment began on February 1, 2024.

Characterizing health-related quality of life and identifying disease predictors among patients suspected of having long COVID: an analysis of COMET-ICE clinical trial data.

Introduction: Long COVID affects health-related quality of life (HRQoL). Here, we investigate the extent to which symptoms experienced during the acute phase of COVID-19 are significant predictors of the presence of long COVID at 12 weeks. Methods: Post-hoc analysis of COMET-ICE trial data, which assessed sotrovimab vs. placebo for treatment of mild-to-moderate COVID-19 among high-risk patients. Patient-reported outcome measures were completed during the trial, including the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus), the 12-Item Short Form (SF-12) Hybrid questionnaire, and the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH). COVID-19 symptoms and impacts (measured by the FLU-PRO Plus) and HRQoL (measured by SF-12 Hybrid and WPAI:GH) were compared between the acute phase (Days 1-21 and 29) and long-COVID phase (at Week 12) among patients with and without long COVID based on COMET-ICE data. Subgroups experiencing long COVID were derived using "All," "Returning," and "Persisting" symptomatic definitions. Long-COVID predictors were identified using a multivariate logistic regression model; odds ratios (ORs) and 95% CIs were calculated. Results: Long-COVID subgroups had significantly higher baseline scores for most FLU-PRO Plus domains and Total Score compared with the non-long-COVID group. WPAI:GH and SF-12 Hybrid scores generally showed significantly more impairment for the long-COVID subgroups at baseline and Week 12 vs. the non-long-COVID group. In the univariate analyses, all FLU-PRO Plus domains were significant predictors of long COVID (all p < 0.05), with the exception of the Sense domain. Older age increased the risk of long COVID (OR 1.02, 95% CI 1.00-1.04, p < 0.05). Non-White patients were significantly less likely to have long COVID by the Returning and Persisting definitions vs. White patients (all p < 0.05). In the multivariate analysis, higher scores for the Nose domain (ORs 3.39-5.60, all p < 0.01) and having COPD (ORs 3.75-6.34, all p < 0.05) were significant long-COVID predictors. Conclusion: Patients who progressed to long COVID had higher symptom severity during the acute disease phase and showed significantly greater negative impact on HRQoL over an extended time period from initial infection through at least the subsequent 3 months. The FLU-PRO Plus Nose domain and having COPD were significant predictors of long COVID.

Integrating Patient-Reported Outcomes Into the Care of People With Advanced Cancer-A Practical Guide.

Patient-reported outcomes (PROs) are being increasingly integrated into routine clinical practice to enhance individual patient care. This has been driven by recognition of the benefits of PROs in enhancing symptom management, patient satisfaction, quality of life, and overall survival, and reductions in acute health care utilization. These benefits are reflected in the emergence of value-based health care initiatives incorporating PRO symptom monitoring such as the Enhancing Oncology Model in the United States. However, implementing PROs can be challenging and it can be difficult to know where to begin to select appropriate PROs, and effectively display and appropriately interpret PRO data. This manuscript summarizes an educational session at the 2024 ASCO Annual Meeting, which provided practical guidance to clinicians seeking to incorporate PROs into the care of people with advanced cancer. We focus on why it is important to collect PROs in routine care from a patient's perspective, how to select PROs for symptom monitoring (including using static patient-reported outcome measures and newer item libraries), and highlight key pearls and pitfalls in the display and interpretation of PROs. We highlight the breadth of existing resources available to guide clinicians in PRO implementation.

Study protocol: group-based psychoeducation for relatives of patients with bipolar disorder-a large scale real-world randomized controlled parallel group trial, the R-bipolar RCT.

BACKGROUND: Relatives of patients with bipolar disorder (BD) often experience emotional burden with stress and depressive symptoms that again increase the likelihood of destabilization and relapses in the patient. The effects of group-based psychoeducation have not been investigated in large-scale real-world settings. We are currently conducting a large-scale real-world randomized controlled parallel group trial (RCT) to test whether group-based psychoeducation for 200 relatives to patients with BD improves mood instability and other critical outcomes in relatives and the corresponding patients with BD. METHODS: The trial is designed as a two-arm, parallel-group randomized trial with a balanced randomization 1:1 to either group-based psychoeducation or a waiting list for approximately 4 months and subsequent group-based psychoeducation. The primary outcome measure is mood instability calculated based on daily smartphone-based mood self-assessments. Other relevant outcomes are measured, including patients' reported outcomes, assessing self-assessed burden, self-efficacy, and knowledge about BD. DISCUSSION: This protocol describes our currently ongoing randomized controlled trial (RCT) that aims at investigating group-based psychoeducation as an intervention for relatives of individuals diagnosed with bipolar disorder (BD). The study is the first large-scale real-world RCT to focus on a relatively short intervention of psychoeducation (6 sessions of 2 h each) in a large group of relatives (approximately 30 participants per group). With this focus, we wish to test an intervention that is feasible to implement in real-life psychiatric settings with limited budgets and time. It is also the first study to use mood instability in relatives as the primary outcome measure and to investigate whether mood instability and other affective symptoms in patients and relatives covary. It could be considered as limitations, that the trial is not blinded and does not include long-term follow-up. TRIAL REGISTRATION: ClinicalTrials.gov NCT06176001. Registered on 2023-12-19. The study is approved by the data agency (P-2021-809). The project was allowed to be initiated without permission from the Scientific Ethical Committees for the Capital Region, because it according to section 1, paragraph 4 of the Committee Act was not defined as a health scientific intervention study (case number 21063013).

12-Month Trajectories of Health-Related Quality of Life Following Hospitalization in German Cancer Centers-A Secondary Data Analysis.

Patient-reported outcomes (PROs) offer a diverse array of potential applications within medical research and clinical practice. In comparative research, they can serve as tools for delineating the trajectories of health-related quality of life (HRQoL) across various cancer types. We undertook a secondary data analysis of a cohort of 1498 hospitalized cancer patients from 13 German cancer centers. We assessed the Physical and Mental Component Scores (PCS and MCS) of the 12-Item Short-Form Health Survey at baseline (t0), 6 (t1), and 12 months (t2), using multivariable generalized linear regression models. At baseline, the mean PCS and MCS values for all cancer patients were 37.1 and 44.3 points, respectively. We observed a significant improvement in PCS at t2 and in MCS at t1. The most substantial and significant improvements were noted among patients with gynecological cancers. We found a number of significant differences between cancer types at baseline, t1, and t2, with skin cancer patients performing best across all time points and lung cancer patients performing the worst. MCS trajectories showed less pronounced changes and differences between cancer types. Comparative analyses of HRQoL scores across different cancer types may serve as a valuable tool for enhancing health literacy, both among the general public and among cancer patients themselves.

Association between physical measures of spinopelvic alignment and physical functioning with patient reported outcome measures (PROMs) after total hip arthroplasty: Protocol for systematic review and meta-analysis.

INTRODUCTION: Prevalence of total hip arthroplasty (THA) has trended upwards over past decades and is projected to increase further. Optimizing outcomes after surgery is essential to avoid surgical revision and maximize outcomes. Low back pain is reported as a problem post THA. Patient-reported outcome measures (PROMs) are commonly used to evaluate THA outcomes but have limitations (e.g., ceiling effects). It is therefore important to assess a comprehensive range of outcomes. Physical outcome measures of spinopelvic alignment and physical functioning demonstrate potential value, but no evidence synthesis has investigated their association with PROMs. The objectives of this systematic review are to evaluate the association between spinopelvic alignment and physical outcome measures of physical functioning with PROMs and characteristics of low back pain after THA. METHODS AND ANALYSIS: This protocol is aligned with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Cross-sectional and longitudinal cohort studies evaluating the association between the physical outcome measures and PROMs (any outcome measures reported) following THA by any approach/implant will be included except surface replacement and revision THA. Studies investigating THA for developmental pathology and inflammatory conditions will be excluded. A systematic search in MEDLINE (Ovid), Embase (Ovid), Scopus, Web of Science, CINAHL, and the grey literature will be carried out from inception to July 31, 2023. Two independent reviewers will evaluate eligibility of retrieved articles, extract data and assess risk of bias (NIH quality assessment tool) of included studies. A third reviewer will mediate disagreements. Random-effects meta-analyses will be conducted if studies are sufficiently homogeneous in design, population, physical measures and PROMs; reporting odds ratios and 95% confidence intervals. Where meta-analyses are not possible, a narrative synthesis will be conducted. Confidence in cumulative evidence will be assessed using a modified GRADE (Grading of Recommendations Assessment, Development, and Evaluation). PROSPERO REGISTRATION NUMBER: PROSPERO Registration number CRD42023412744.

Performance of Medication Tasks: Relationship Among Patient-Reported Outcomes, Performance-Based Assessments, and Objective Assessments.

IMPORTANCE: Occupational therapy practitioners use standardized assessments to guide their clinical decision-making, but it is unclear how well performance on standardized assessments translates to performance at home. OBJECTIVE: To understand the concurrent and predictive validity of patient-reported outcomes and performance-based assessments for monitoring performance at home within the context of medication management and adherence. DESIGN: Exploratory study. SETTING: Participants completed standardized assessments in a lab or at home, which were followed by home-based electronic monitoring of medication adherence. PARTICIPANTS: Sixty community-dwelling adults with hypertension or stroke who independently took antihypertensive medications. OUTCOMES AND MEASURES: Participants completed the Hill-Bone Medication Adherence Scale, the Hill-Bone Medication Adherence Reasons Scale, the Performance Assessment of Self-Care Skills Medication Management subtask, and the Executive Function Performance Test-Enhanced Medication Management subtest. Then, they used an electronic pill cap to monitor medication adherence at home for 1 month. RESULTS: Patient-reported outcomes and performance-based assessments in the context of medication management and adherence demonstrated poor concurrent and predictive validity to medication adherence at home. CONCLUSIONS AND RELEVANCE: There is a gap between what people think they will do, what they can do on a standardized assessment, and what they actually do at home. Future research is needed to strengthen concurrent and predictive validity to clinically meaningful outcomes. Plain-Language Summary: Occupational therapy practitioners should use caution when using standardized assessments to try to predict client performance at home. They should also continue to use a battery of assessments, clinical reasoning, and client preferences to guide their decision-making for monitoring performance at home within the context of medication management and adherence.

Telehealth cognitive behaviour therapy for the management of sleep disturbance in women with early breast cancer receiving chemotherapy: a feasibility study.

PURPOSE: Sleep quality commonly deteriorates in people receiving chemotherapy for breast cancer (BC). We aimed to determine feasibility and acceptability of telehealth-delivered cognitive behaviour therapy for insomnia (CBT-I) in people with early BC receiving (neo)adjuvant chemotherapy. METHODS: Multi-centre, single arm, phase 2 feasibility trial. People with stage I-III BC received 4 sessions of telehealth CBT-I over 8 weeks, during chemotherapy. Participants completed Pittsburgh Sleep Quality Index (PSQI) and other Patient Reported Outcome Measures (PROMs) at baseline, post-program (week 9) and post-chemotherapy (week 24); and an Acceptability Questionnaire at week 9. Primary endpoint was proportion completing 4 sessions of telehealth CBT-I. RESULTS: In total, 41 participants were recruited: mean age 51 years (range 31-73). All 4 CBT-I sessions were completed by 35 (85%) participants. Acceptability of the program was high and 71% reported 'the program was useful'. There was no significant difference in the number of poor sleepers (PSQI score ≥ 5) at baseline 29/40 (73%) and week 24 17/25 (68%); or in the mean PSQI score at baseline (7.43, SD 4.06) and week 24 (7.48, SD 4.41). From baseline to week 24, 7/25 (28%) participants had a ≥ 3 point improvement in sleep quality on PSQI, and 5/25 (20%) had a ≥ 3 point deterioration. There was no significant difference in mean PROM scores. CONCLUSION: It is feasible to deliver telehealth CBT-I to people with early BC receiving chemotherapy. Contrary to literature predictions, sleep quality did not deteriorate. Telehealth CBT-I has a potential role in preventing and managing sleep disturbance during chemotherapy. Australian New Zealand Clinical Trials Registry (ANZCTR) registration number: ACTRN12620001379909 and date 22/12/2020.

Hip arthroscopy with initial access to the peripheral compartment for femoroacetabular impingement: midterm results from a large-scale patient cohort.

BACKGROUND: Hip arthroscopy with initial access to the peripheral compartment could reduce the risk of iatrogenic injury to the labrum and cartilage; furthermore, it avoids the need for large capsulotomies with separate portals for peripheral and central (intra-articular) arthroscopy. Clinical results of the peripheral-compartment-first technique remain sparse, in contrast to those of conventional hip arthroscopy starting in the intra-articular central compartment. The purpose of this study was to assess outcome of hip arthroscopy with the peripheral-compartment-first technique, including complication rates, revision rates and patient-reported outcome scores. MATERIALS AND METHODS: This outcome study included 704 hips with femoroacetabular impingement. All arthroscopies were performed using the peripheral-compartment-first technique. A joint replacement registry and the institutional database were used to assess the revision and complication rates, while patient-reported outcome measures were used to assess functional outcomes and patient satisfaction. RESULTS: In total, 704 hips (615 patients) were followed up for a mean of 6.2 years (range 1 to 9 years). The mean age of the patients was 32.1 ± 9.2 years. During the follow-up period, 26 of 704 (3.7%) hips underwent total hip arthroplasty (THA) after a mean of 1.8 ± 1.2 years, and 18 of the 704 (2.6%) hips required revision hip arthroscopy after a mean of 1.2 ± 2.1 years. 9.8% of the hips had an unsatisfactory patient-reported outcome at final follow-up. CONCLUSIONS: The results for the peripheral-compartment-first technique were promising. We recommend a well-conducted randomized controlled clinical trial to guide future therapeutic recommendations regarding the most favorable hip arthroscopy technique. LEVEL OF EVIDENCE: Level IV, therapeutic study. TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov (U.S. National Library of Medicine; ID: NCT05310240).

Patient-reported outcomes with selpercatinib treatment in patients with RET-driven cancers in the phase I/II LIBRETTO-001 trial.

BACKGROUND: This post-hoc retrospective study describes long-term patient-reported outcomes (PROs) for REarranged during Transfection (RET)-altered non-small-cell lung cancer (NSCLC), medullary thyroid cancer (MTC), non-MTC thyroid cancer (TC), and tumor agnostic (TA) patients (Data cut-off: January 2023) from the LIBRETTO-001 trial. PATIENTS AND METHODS: Patients completed the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30). Patients with MTC also completed a modified version of the Systemic Therapy-Induced Diarrhea Assessment Tool (mSTIDAT). The proportion of patients with improved, stable, or worsened status after baseline was reported. PROs were summarized at 3 years (cycle 37) post-baseline for the NSCLC and MTC cohorts, and at 2 years (cycle 25) post-baseline for the TC and TA cohorts. Time-to-event outcomes (time to first improvement or worsening and duration of improvement) were reported. RESULTS: The baseline assessment was completed by 200 (63.3%), 209 (70.8%), 50 (76.9%), and 38 (73.1%) patients in the NSCLC, MTC, TC, and TA cohorts, respectively. The total compliance rate was 80%, 82%, 70%, and 85%, respectively. Approximately 75% (NSCLC), 81% (MTC), 75% (TC), and 40% (TA) of patients across all cohorts reported improved or stable QLQ-C30 scores at year 3 (NSCLC and MTC) or year 2 (TC and TA) with continuous selpercatinib use. Across cohorts, the median time to first improvement ranged from 2.0 to 19.4 months, the median duration of improvement ranged from 1.9 to 28.2 months, and the median time to first worsening ranged from 5.6 to 44.2 months. The total compliance rate for the mSTIDAT was 83.7% and the proportion of patients with MTC who reported diarrhea on the mSTIDAT was reduced from 80.8% at baseline to 35.6% at year 3. CONCLUSIONS: A majority of patients with RET-driven cancers improved or remained stable on most QLQ-C30 domains, demonstrating favorable health-related quality of life as measured by the QLQ-C30 during long-term treatment with selpercatinib.

Chat-ePRO: Development and pilot study of an electronic patient-reported outcomes system based on ChatGPT.

OBJECTIVE: Chatbots have the potential to improve user compliance in electronic Patient-Reported Outcome (ePRO) system. Compared to rule-based chatbots, Large Language Model (LLM) offers advantages such as simplifying the development process and increasing conversational flexibility. However, there is currently a lack of practical applications of LLMs in ePRO systems. Therefore, this study utilized ChatGPT to develop the Chat-ePRO system and designed a pilot study to explore the feasibility of building an ePRO system based on LLM. MATERIALS AND METHODS: This study employed prompt engineering and offline knowledge distillation to design a dialogue algorithm and built the Chat-ePRO system on the WeChat Mini Program platform. In order to compare Chat-ePRO with the form-based ePRO and rule-based chatbot ePRO used in previous studies, we conducted a pilot study applying the three ePRO systems sequentially at the Sir Run Run Shaw Hospital to collect patients' PRO data. RESULT: Chat-ePRO is capable of correctly generating conversation based on PRO forms (success rate: 95.7 %) and accurately extracting the PRO data instantaneously from conversation (Macro-F1: 0.95). The majority of subjective evaluations from doctors (>70 %) suggest that Chat-ePRO is able to comprehend questions and consistently generate responses. Pilot study shows that Chat-ePRO demonstrates higher response rate (9/10, 90 %) and longer interaction time (10.86 s/turn) compared to the other two methods. CONCLUSION: Our study demonstrated the feasibility of utilizing algorithms such as prompt engineering to drive LLM in completing ePRO data collection tasks, and validated that the Chat-ePRO system can effectively enhance patient compliance.

The first decade of the Danish Palliative Care Database: improvements and ongoing challenges in the quality and use of specialised palliative care.

BACKGROUND: Danish Palliative Care Database comprises five quality indicators: (1) Contact with specialised palliative care (SPC) among referred patients, (2) Waiting time of less than 10 days, (3) Proportion of patients who died from (A) cancer or (B) non-cancer diseases, and had contact with SPC, (4) Proportion of patients completing the patient-reported outcome measure at baseline (EORTC QLQ-C15-PAL), and (5) Proportion of patients discussed at a multidisciplinary conference. PURPOSE: To investigate changes in the quality indicators from 2010 until 2020 in cancer and non-cancer patients. Patients/material: Patients aged 18+ years who died from 2010 until 2020. METHOD: Register-based study with the Danish Palliative Care Database as the main data source. Indicator changes were reported as percentage fulfilment. RESULTS: From 2010 until 2020, the proportion of patients with non-cancer diseases in SPC increased slightly (2.5-7.2%). In 2019, fulfilment of the five indicators for cancer and non-cancer were: (1) 81% vs. 73%; (2) 73% vs. 68%; (3A) 50%; (3B) 2%; (4) 73% vs. 66%; (5) 73% vs. 65%. Whereas all other indicators improved, the proportion of patients waiting less than 10 days from referral to contact decreased. Differences between type of unit were found, mainly lower for hospice. INTERPRETATION: Most patients in SPC had cancer. All indicators except waiting time improved during the 10-year period. The establishment of the Danish Palliative Care Database may have contributed to the positive development; however, SPC in Denmark needs to be improved, especially regarding a reduction in waiting time and enhanced contact for non-cancer patients.

Total knee arthroplasty following lateral closing-wedge high tibial osteotomy versus primary total knee arthroplasty: a propensity score matching study.

BACKGROUND: The disparity in patient-reported outcomes between total knee arthroplasty (TKA) following high tibial osteotomy (HTO) and primary TKA has yet to be fully comprehended. This study aims to compare the patient-reported outcomes, radiological parameters and complication rates between TKA following HTO and primary TKA. METHODS: Sixty-five patients who underwent TKA following lateral closing-wedge HTO were compared to a matched group of primary TKA at postoperative 6-months and 1-year. Between-group confounders of age, gender, smoking status, Body Mass index, preoperative Numeric Rating Scale (NRS) pain in rest, Knee injury and Osteoarthritis Outcome Score-Physical function Shortform (KOOS-PS), EuroQol five-dimensional (EQ-5D) overall health score, and Oxford Knee Score (OKS) were balanced by propensity score matching. Patient-reported outcome measures were NRS pain in rest, KOOS-PS, EQ-5D overall health score, and OKS. Radiological parameters were femorotibial angle, medial proximal tibial angle, anatomical lateral distal femoral angle, posterior tibial slope, and patellar height assessed by Insall-Salvati ratio. The complication rates of TKA were compared between the two groups. The HTO survival time, the choice of staple removal before or during TKA in patients who underwent TKA following HTO patients, and the rate of patellar resurfacing were assessed. The p value < 0.0125 indicates statistical significance after Bonferroni correction. RESULTS: After propensity score matching, no significant between-group differences in the patient-reported outcome measures, radiographical parameters and complication rates were found (p > 0.0125). In the TKA following HTO group, with an average HTO survival time of 8.7 years, staples were removed before TKA in 46 patients (71%) and during TKA in 19 patients, and 11 cases (17%) had patella resurfacing. In the primary TKA group, 15 cases (23%) had patella resurfacing. CONCLUSION: The short-term assessment of TKA following HTO indicates outcomes similar to primary TKA. A previous HTO does not impact the early results of subsequent TKA, suggesting that the previous HTO has minimal influence on TKA outcomes. LEVEL OF EVIDENCE: III, cohort study.