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Study Design: Prospective, multicenter, international, observational study Objective: Identify independent prognostic factors associated with achieving the minimal clinically important difference (MCID) in patient reported outcome measures (PROMs) among adult spinal deformity (ASD) patients ≥60 years of age undergoing primary reconstructive surgery. Methods: Patients ≥60 years undergoing primary spinal deformity surgery having ≥5 levels fused were recruited for this study. Three approaches were used to assess MCID: (1) absolute change:0.5 point increase in the SRS-22r sub-total score/0.18 point increase in the EQ-5D index; (2) relative change: 15% increase in the SRS-22r sub-total/EQ-5D index; (3) relative change with a cut-off in the outcome at baseline: similar to the relative change with an imposed baseline score of ≤3.2/0.7 for the SRS-22r/EQ-5D, respectively. Results: 171 patients completed the SRS-22r and 170 patients completed the EQ-5D at baseline and at 2 years postoperative. Patients who reached MCID in the SRS-22r self-reported more pain and worse health at baseline in both approaches (1) and (2). Lower baseline PROMs ((1) – OR:.01 [.00-.12]; (2)- OR:.00 [.00-.07]) and number of severe adverse events (AEs) ((1) – OR:.48 [.28-.82]; (2)- OR:.39 [.23-.69]) were the only identified risk factors. Patients who reached MCID in the EQ-5D demonstrated similar characteristics regarding pain and health at baseline as the SRS-22r using approaches (1) and (2). Higher baseline ODI ((1) – OR: 1.05 [1.02-1.07]) and number of severe AEs (OR:.58 [.38-.89]) were identified as predictive variables. Patients who reached MCID in the SRS22r experienced worse health at baseline using approach (3). The number of AEs (OR:.44 [.25-.77]) and baseline PROMs (OR:.01 [.00-.22] were the only identified predictive factors. Patients who reached MCID in the EQ-5D experienced less AEs and a lower number of actions taken due to the occurrence of AEs using approach (3). The number of actions taken due to AEs (OR:.50 [.35-.73]) was found to be the only predictive variable factor. No surgical, clinical, or radiographic variables were identified as risk factors using either of the aforementioned approaches. Conclusion: In this large multicenter prospective cohort of elderly patients undergoing primary reconstructive surgery for ASD, baseline health status, AEs, and severity of AEs were predictive of reaching MCID. No clinical, radiological, or surgical parameters were identified as factors that can be prognostic for reaching MCID. [ABSTRACT FROM AUTHOR]

Aim Method Results Conclusion To identify patient‐reported complaints affecting quality of life in Crohn's disease patients with a perianal fistula, and to compare differences between subgroups.A questionnaire was distributed to 1667 patients from the Dutch Crohn's and Colitis Patients' organization, those patients with Crohn's disease and perianal fistula were included. Patients were asked to report (using free text) their most important fistula‐related complaints affecting their quality of life. All responses were structurally analyzed and categorized. Data comparisons were made between subgroups: women versus men, patients with versus without current presence of a seton, and patients aged ≤40 versus >40 years.Of 743 respondents (44.6%), 123 patients with Crohn's disease and perianal fistula were included (92 women, median age 41 years [IQR 34–56] and 36 with seton). A total of 776 complaints were allocated to 36 categories, with 19 reported in >10% of patients. Perianal fistula‐related complaints affected nearly all patients (95.9%). Impact on psychological status (71.7% vs. 29.0%; p < 0.0001) and on sexual activities (37.0% vs. 16.1%; p = 0.003) were more common in women than men. Younger patients more often reported insecurity (38.7% vs. 18.0%; p = 0.026), shame (29.0% vs. 11.5%; p = 0.024), and impact on sexual activities (40.3% vs. 23.0%; p = 0.048) than older patients. Patients with a seton more frequently reported self‐experienced malodour (50.0% vs. 23.0%; p = 0.005), physical activity limitations (41.7% vs. 19.5%; p = 0.014), and work/study impact (22.2% vs. 5.7%; p = 0.019).We identified 19 perianal fistula‐related complaints reported by >10% of patients. These complaints may guide improvement of current outcome measures. [ABSTRACT FROM AUTHOR]

AbstractPurposeMethodsResultsConclusions\nIMPLICATIONS FOR REHABILITATIONTo translate and culturally adapt the Brachial Assessment Tool (BrAT) into Swedish and evaluate the internal consistency, and internal content validity using Rasch analysis in patients with traumatic brachial plexus injuries (TBPI).The translation was made in accordance with international guidelines. TBPI patients were identified in clinical records. The BrAT-Swe was sent out to patients by post. Internal consistency was assessed using Cronbach alpha and content validity using Rasch analysis evaluating fit to the Rasch model, threshold response, local dependency, dimensionality, differential item functioning (DIF), and targeting.The translation of the BrAT was completed without major discrepancies. A total of 164 patients completed the BrAT-Swe. Internal consistency ranged from 0.90 to 0.98. Rasch analysis supported the content validity. All subscales demonstrated fit to the model with no local dependency, minimal disordered thresholds and no unidimensionality. Uniform DIF for item 6 by age, was identified. Minimal differences in hierarchical ordering were identified.This study presents a Swedish translation of the BrAT (BrAT-Swe) and has demonstrated that the translated BrAT-Swe is well adapted for Swedish circumstances. Analysis supports the internal content validity of the BrAT-Swe as a unidimensional targeted PROM designed to assess activity limitation after TBPI.The Swedish translation of the Brachial Assessment Tool (BrAT), the BrAT-Swe, is a valid instrument that can be used in a Swedish context.The BrAT-Swe subscales can be used independently or as a total score, similar to the original BrAT.The BrAT-Swe may be used to guide rehabilitation and for goal setting for patients with traumatic brachial plexus injury.The Swedish translation of the Brachial Assessment Tool (BrAT), the BrAT-Swe, is a valid instrument that can be used in a Swedish context.The BrAT-Swe subscales can be used independently or as a total score, similar to the original BrAT.The BrAT-Swe may be used to guide rehabilitation and for goal setting for patients with traumatic brachial plexus injury. [ABSTRACT FROM AUTHOR]

Background: There is inadequate evidence of the efficacy of greater occipital nerve block (GONB) for the preventive treatment of cluster headaches. We assessed the efficacy and tolerability of GONB injections as a transitional preventive treatment for episodic cluster headaches (ECH). Methods: This randomized, double-blind, placebo-controlled, parallel-group trial conducted at GB Pant Institute of Postgraduate Medical Education and Research, New Delhi, India, included ECH patients diagnosed by ICHD-3 criteria, aged 18–65, with one or more attacks per 24 h for seven days before randomization (baseline). ECH patients were either not on preventive medications or on stable doses for at least three months. ECH patients were randomized to receive active GONB (2 ml methylprednisolone (80 mg) and 2 ml lignocaine (2%)) and placebo (4 ml saline injections). Before giving GONB, lignocaine jelly was applied topically to mask the effect of numbness following the GONB. The primary efficacy endpoint was the mean change in weekly attack frequency from baseline to Week 4. Efficacy analyses were performed in a modified intention-to-treat population that included all patients who received at least one injection of GONB and had a follow-up for one week following GONB. The safety analysis included treatment-emergent adverse effects (TEAE) in all patients who received at least one dose of investigational product. The trial was registered with the Clinical Trials Registry of India (CTRI/2021/21/038397). Results: Forty ECH patients were randomized between December 2021 and January 2023. Thirty-nine patients (19 in the active and 20 in the placebo groups) were available for efficacy analysis. The change in weekly attack frequency from baseline to Week 4 was −11.1 (95% CI: −8.5 to −4.4) for the active group compared to −7.7 (95% CI: −11.8 to −9.8) for placebo (mean difference −3.4 (95% CI: −5.2 to −1.7, p < 0.001). We noted TEAE in 18 (90%) of 20 patients who received the active drug and in 18 (90%) of 20 patients who received a placebo (p = 0.38). The common TEAE were local site bleeding and pain, which were mild and transient. No serious adverse events were reported. Conclusion: This study found that GONB with methylprednisolone and lignocaine significantly reduced the weekly attack frequency from baseline to Week 1 through Week 4 in ECH patients compared to a placebo. GONB was well tolerated. [ABSTRACT FROM AUTHOR]

Context: The hypothalamic-pituitary-adrenal axis is a critical regulator of circadian rhythm in humans. Impaired sleep adversely affects metabolic, emotional, and cognitive health. Objective: To characterize sleep disturbances in patients with active and treated Cushing's syndrome (CS), and identify factors associated with impaired sleep in treated patients. Design: Single-center cross-sectional study. Methods: Patients with pituitary or adrenal CS enrolled in an observational study completed Nottingham Health Profile (NHP), CushingQoL, and Hospital Anxiety and Depression assessments. Cross-sectional analysis was conducted including patients with active and treated disease. Results: 113 (94 female) patients with CS were included, 104 pituitary and 9 adrenal, with mean age at diagnosis of 43.9 ± 13.4 years. Mean and maximum duration of follow up was 5.1 and 23 years. Mean NHP sleep score was lower (i.e., improved) in patients with treated vs. active disease (29.6 ± 30.2 vs. 51.9 ± 30.9, p = 0.0005), as was CushingQoL sleep score (p = 0.015), but 41.5% of patients with treated disease stated they often or always had trouble sleeping. The proportion of treated vs. active patients taking medication for sleep, mood, or pain was not different. Neither NHP nor CushingQoL pain scores were lower in treated vs. active patients (p = 0.39 and 0.53). In patients with treated CS, anxiety and depression correlated with worse sleep scores. Conclusions: Patients with treated CS report improved sleep quality compared to those with active disease, but almost half of treated patients still report sleep challenges. The need for sleep medications, reported by one third of patients, was not different after CS treatment. Ongoing mood disturbances may play a role in persistent sleep disruption. Further work should focus on determinants of sleep impairments in treated CS patients. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to determine the psychometric properties of the Spanish-language version of the HIV-Symptom Index (HIV-SI) questionnaire in Spanish patients undergoing antiretroviral therapy. Methods: Between 2014 and 2016, an observational, multicenter, prospective cohort study was conducted in seventeen Spanish hospitals to validate HIV-SI questionnaire in terms of: construct validity (confirmatory factor analysis), internal consistency (Cronbach's alpha), convergent validity (Pearson's correlation coefficient) and Known-group validity. In addition, a sensitivity to change analysis was also performed. Results: A total of 232 patients were included in the study. They had a mean age of 46.17 (SD9.82) and were 75% male. The median overall score for the HIV-SI was 10 (IQR 4– 19.5) and the most common symptoms reported were feelings of nervousness or anxiety, fatigue or energy loss, feeling sad or depressed, stomach pain or bloating, and difficulty sleeping. In the current study, the Spanish HIV-SI questionnaire showed a high internal consistency (α = 0.89) and adequate construct validity (CFI and TLI > 0.90). When contrasted with the MOS-HIV questionnaire, an inverse correlation was found. It showed a good association with the mental (r=-0.61; P < 0.0001) and physical score (r=-0.60; P < 0.0001). In a multivariate analysis, the age of the patient, female condition, hepatitis C coinfection, concomitant treatment and non-adherence resulted in a higher HIV-SI score. Conclusions: Our study has shown that the Spanish HIV-SI is a valid and reliable self-administered PROM for routine measurement of patient- reported symptoms among Spanish patients on antiretroviral treatment. [ABSTRACT FROM AUTHOR]

Introduction: Total knee arthroplasty (TKA) is used for tricompartmental knee osteoarthritis, while unicompartmental knee arthroplasty (UKA) is preferred for unicompartmental knee osteoarthritis. Bicompartmental knee arthroplasty (BKA) aims to address 2 knee compartments by combining 2 UKA's or 1 UKA with a patellofemoral replacement. This study examines the clinical outcomes of BKA, focusing on pain alleviation and knee function. The aim of this study is to report the functional outcome of BKA and see if this aligns with BKA outcomes from literature in terms of patient reported outcome measurements (PROMs) and range of motion (ROM) after a 2-year follow-up. Additionally, radiographic alignment, implant survivorship, adverse events and length of stay are secondary outcomes. Methods: This is a cohort study of 21 patients who underwent BKA for medial and patellofemoral osteoarthritis. The patients had follow-up for at least 2 years postoperatively. PROMs were assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS), Knee Society Score (KSS), Oxford Knee Score, Western Ontario and McMaster University Osteoarthritis index (WOMAC) and the Visual Analogue Scale (VAS). ROM was measured using a goniometer. Pre- and postoperative radiographic coronal alignment was measured using standard full leg radiographs. Patient demographics, implant survivorship, length of stay and adverse events were recorded. Result: Twenty-one patients (23 knees) were included, with a mean follow-up of 41 months (standard deviation [SD] 12 months; range 24–59 months). Patient-reported outcome measures (PROMs) demonstrated significant improvements, with 80% achieving good to excellent OKS and KSS scores. KOOS scores were similar to scores found in literature. The WOMAC score was higher in our results compared to other authors. Which indicates worse outcome. The mean preoperative hip-knee-ankle angle (HKAA) was 2.4 degrees varus (SD 1.9 degrees; range 1.2 degrees valgus − 6.1 degrees varus), while the mean postoperative HKAA was 0.3 degrees valgus (SD 2.8 degrees; range 4.6 degrees valgus − 5.6 degrees varus) (p < 0.001). Postoperative range of motion averaged 117 degrees (SD 10 degrees; range 98–132). Conclusions: BKA shows promise in alleviating pain and improving knee function in patients with medial and patellofemoral osteoarthritis. Challenges include the risk of revision and technical difficulties during surgery. Comparative studies suggest similar outcomes between BKA and TKA, with potential advantages for younger, more active patients. Further research, particularly randomized trials with larger cohorts, is necessary to elucidate the long-term benefits and drawbacks of BKA compared to other knee arthroplasty options. [ABSTRACT FROM AUTHOR]

Craving is considered one of the defining characteristics for alcohol or substance use disorders. There is no consensus on the underlying processes of craving, although multiple models exist. Craving is a very individualistic symptom and has to be self‐reported. Several instruments have been developed to measure craving, without a recognized gold standard. The patient's perspective appears critical to determine the relevance of the numerous existing tools. We assessed the contribution of patients to the development of these instruments. We performed a systematic review of instruments measuring alcohol craving published from 2012 to 2023 from three databases (PubMed, PsycInfo, and Embase) in addition to those identified in a previous review by Kavanagh et al. from 1990 to 2012. We included all articles related to the development or validation of instruments for the assessment of alcohol craving. We identified and included in this review the corresponding instruments. Articles translating existing instruments without validation or on single‐item instruments were excluded. We analyzed the articles in accordance with COnsensus‐based Standards for the selection of health Measurement INstruments (COSMIN) recommendations to assess patient involvement in the creation of patient‐reported outcome measures (PROM). Two key aspects were investigated: (1) the general design, encompassing the quality of construct description, identification of elements pertinent to a PROM, particularly the inclusion of concepts provided by patients, and (2) the quality of cognitive interviews (when conducted), to evaluate the comprehensiveness and comprehensibility of the PROM. We included 22 articles identifying 16 instruments for measuring alcohol craving. Patients only contributed to item development for one instrument and its short version (QAU and AUQ). None of the instruments met all of the developmental quality criteria, with 14 classed as "inadequate" and two as "doubtful." The current instruments measuring alcohol craving were developed with poor patient contribution, although most articles did not adequately report patient involvement. Patients' perspectives on craving should be explored for future patient‐centered approach. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to translate the Exercise Benefits/Barriers Scale (EBBS) into Turkish and investigate the perceptions of Turkish-speaking patients with different axial spondyloarthritis (axSpA) subtypes regarding exercise benefits and barriers. Patients and methods: This validation study was conducted between June 2018 and December 2021. Patients with axSpA were consecutively assessed regarding physical (age, sex and body mass index) and disease-related characteristics (disease activity, spinal mobility, functional status, quality of life, health status, emotional status, and kinesiophobia). Eligible participants were asked to complete the EBSS and other outcome measurements during their initial visits. EBBS was readministered 7 to 14 days later. Results: One hundred forty-eight patients (89 males, 59 females; mean age: 44.3±11.8 years; range, 19 to 65 years) were included in the study. Of the patients, 108 had radiographic axSpA, and 40 had nonradiographic axSpA. EBBS-Barriers and EBBS-Benefits subscales demonstrated adequate internal consistency (Cronbach’s alphas of 0.82 and 0.95, respectively) and test-retest reliability (intraclass correlation coefficients of 0.837 and 0.807, respectively). No significant differences were observed between axSpA subtypes regarding EBBS-Barriers (p=0.12) and EBBS-Benefits (p=0.10) subscales. Significant relationships were detected between kinesiophobia and EBBS-Barriers scores (r=–0.424, p<0.01), as well as EBBS-Benefits scores (r=–0.344, p<0.01) for all patients. EBBS-Benefits scores were correlated to health status (r=–0.412, p=0.08) and quality of life (r=–0.394, p=0.01) in patients with nonradiographic axSpA. Conclusion: According to our results, the Turkish EBBS is a valid and reliable tool for patients with axSpA. Perceptions of the patients with axSpA regarding exercise barriers and benefits do not differ according to the disease subtype. It appears that kinesiophobia may be an important parameter regarding exercise perception in axSpA. [ABSTRACT FROM AUTHOR]

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Abstract Background The aim of this study was to determine the psychometric properties of the Spanish-language version of the HIV-Symptom Index (HIV-SI) questionnaire in Spanish patients undergoing antiretroviral therapy. Methods Between 2014 and 2016, an observational, multicenter, prospective cohort study was conducted in seventeen Spanish hospitals to validate HIV-SI questionnaire in terms of: construct validity (confirmatory factor analysis), internal consistency (Cronbach’s alpha), convergent validity (Pearson’s correlation coefficient) and Known-group validity. In addition, a sensitivity to change analysis was also performed. Results A total of 232 patients were included in the study. They had a mean age of 46.17 (SD9.82) and were 75% male. The median overall score for the HIV-SI was 10 (IQR 4– 19.5) and the most common symptoms reported were feelings of nervousness or anxiety, fatigue or energy loss, feeling sad or depressed, stomach pain or bloating, and difficulty sleeping. In the current study, the Spanish HIV-SI questionnaire showed a high internal consistency (α = 0.89) and adequate construct validity (CFI and TLI > 0.90). When contrasted with the MOS-HIV questionnaire, an inverse correlation was found. It showed a good association with the mental (r=-0.61; P

Abstract Background Minimally invasive cardiac surgery (MICS) has garnered significant attention for its potential benefits, including decreased surgical trauma, accelerated recovery, and improved aesthetic outcomes. This case series aims to elucidate the technical aspects and assess the aesthetic, functional, and quality of life outcomes associated with the utilization of a periareolar incision approach in female patients undergoing cardiac surgery. Methods The periareolar MICS technique, performed with or without high-definition (HD) 3D endoscopic visualization, limited rib-spreading, and a periareolar incision spanning the 3 to 9 o’clock positions, was employed. We present a case series encompassing five female patients who underwent various cardiac procedures for different pathologies using this approach. Results No intraoperative complications occurred, and all patients experienced uneventful postoperative recoveries. The periareolar approach resulted in well-healed incisions with minimal scaring, preserving breast contour and yielding satisfactory cosmetic outcomes. Patients reported negligible pain levels and expressed contentment with the scar appearance. Conclusion The periareolar incision technique in MICS represents an efficacious approach characterized by favorable aesthetic outcomes and enhanced patient experience. Further investigations are warranted to compare different MICS approaches with respect to pain management and their impact on quality-of-life domains.

Abstract Background Transition of care from hospitalisation to home is a complex process with potential patient safety risks, especially for patients with multimorbidity. Traditionally, the quality of transition of care has been evaluated primarily through readmission rates. However, interpreting the readmission rates presents challenges, and readmission rates fail to capture the patient’s perspective on the quality of the care transition. Insight into the patient’s experience with their care or a health service can be provided through the use of patient-reported experience measures (PREMs), and the two PREMs Care Transitions Measure 15 (CTM-15) and Partners at Care Transitions Measure part 1 and 2 (PACT-M1 and PACT-M2) assess on the quality of transition of care from the patients’ perspective. The aim of this study was to translate, culturally adapt, and assess content validity of CTM-15, PACT-M1, and PACT-M2 for Danish-speaking patients with multimorbidity. Methods A two-step approach was used for content validation, involving cognitive debriefing and interviews with patients, representing the target group, as well as quantitative data collection from healthcare professionals representing all three sectors of the Danish healthcare system. The patients were systematically interviewed regarding the aspects of content validity; comprehensibility, relevance, and comprehensiveness. The healthcare professionals assessed the relevance and comprehensiveness of each item through questionnaires, allowing the calculation of a content validity index (CVI). An item CVI ≥ 0.78 is considered good. Results The results of the qualitative data indicated that both CTM-15 and the PACT-M questionnaires were considered relevant, and comprehensible, and comprehensive to the target group. The CVI computed at item level determined that PACT-M1 and PACT-M2 demonstrated excellent content validity among the healthcare professionals, whereas the CVI for two items of the CTM-15 fell below the threshold value for “good”. Conclusion The Danish versions of the PACT-M questionnaires demonstrated good content validity, and the CTM-15 demonstrated acceptable content validity based on qualitative data from patients and quantitative data from healthcare professionals. Further validation of the questionnaires, by assessing their construct validity and reliability is recommended.

Abstract Objectives To determine the functional domains and symptom scales that affect patients most following radical cystectomy (RC) and urinary diversion (UD), and if a single instrument (or combination) adequately captures these bothersome symptoms. It is unclear whether current patient reported outcome (PRO) instruments that have been used to assess quality of life in patients following RC and UD adequately cover the most bothersome symptoms affecting patients. Materials and methods A systematic search of MEDLINE, EMBASE, PubMed, Cinahl and Cochrane was conducted from January 2000 to May 2023 for original articles of patients who had RC and UD since 2000 for muscle invasive bladder cancer. The Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) process was followed. Extracted data included the PRO measures used, domains reported and scores in the first 12 months post‐surgery (short‐term) and after 12 months (long‐term). A conservative threshold of 30 for symptom domains was used to determine which PRO domains were potentially concerning to patients in each study. Quality assessment was performed using the QUALSYST appraisal tool. Results Thirty‐five studies met the inclusion criteria, including a total of eight unique PRO instruments. The main findings indicated that physical function was the most concerning PRO for patients with both neobladder (NB) and ileal conduit (IC) in the short and long term. Additionally, bowel, urinary and sexual bother were concerning symptoms for patients with NB in the long‐term, but only in the short‐term for those with IC. Conclusions The main issues are adequately addressed using the combination of EORTC QLQ‐C30 and QLQ‐BLM30 instruments.

Background: Minimally invasive cardiac surgery (MICS) has garnered significant attention for its potential benefits, including decreased surgical trauma, accelerated recovery, and improved aesthetic outcomes. This case series aims to elucidate the technical aspects and assess the aesthetic, functional, and quality of life outcomes associated with the utilization of a periareolar incision approach in female patients undergoing cardiac surgery. Methods: The periareolar MICS technique, performed with or without high-definition (HD) 3D endoscopic visualization, limited rib-spreading, and a periareolar incision spanning the 3 to 9 o'clock positions, was employed. We present a case series encompassing five female patients who underwent various cardiac procedures for different pathologies using this approach. Results: No intraoperative complications occurred, and all patients experienced uneventful postoperative recoveries. The periareolar approach resulted in well-healed incisions with minimal scaring, preserving breast contour and yielding satisfactory cosmetic outcomes. Patients reported negligible pain levels and expressed contentment with the scar appearance. Conclusion: The periareolar incision technique in MICS represents an efficacious approach characterized by favorable aesthetic outcomes and enhanced patient experience. Further investigations are warranted to compare different MICS approaches with respect to pain management and their impact on quality-of-life domains. [ABSTRACT FROM AUTHOR]

Background: Despite the significant impact of oral problems on the quality of life of palliative care patients, comprehensive studies are lacking. This study is the first of its kind to address this gap by including both a dental examination and an intervention and assessing quality of life using the EORTC QLQ OH 15 questionnaire. Objectives: The objective of this study is to explore the impact of incorporating dentists into inpatient palliative care, with a focus on enhancing quality of life and alleviating symptom burden. Methods: In this monocentric study, data were gathered from a palliative care unit over an 8-month period. At the beginning of the multidisciplinary treatment, T0, patients underwent both a dental examination and interviews utilizing established questionnaires, the EORTC QLQ-C30 (core, general) and OH 15 (oral health). A week later, at T1, patients underwent a follow-up examination and interview. The QLQ-C30 and OH15 are widely recognized instruments developed by the European Organisation for Research and Treatment of Cancer (EORTC) for evaluating health related quality of life in cancer patients. Results: A total of n = 103 patients (48.5% women) were enrolled in the study. The median duration since their last dental visit was 1 year, and the dental condition at T0 was desolate. At T1, statistically and clinically significant changes in oral quality of life and symptom burden were observed. Noteworthy changes were noted in the OH-QoL score (median 63 vs. 92, p < 0.001), sticky saliva (median 33 vs. 0, p < 0.001), sensitivity to food and drink (median 33 vs. 0, p < 0.001), sore mouth (median 33 vs. 0, p > 0.001), and poorly fitting dentures (median 33 vs. 0 p < 0.001). Additionally, improvements were observed in xerostomia candidiasis and mucositis. Conclusion: The study highlights the powerful contribution of integrating a dentist in inpatient palliative care. With very little dental effort and simple ward and bedside treatments, significant improvements in the oral symptom burden of critically ill palliative patients can be achieved. This contributes to improved care status, relief of distressing symptoms, and ultimately improved quality of life. The results strongly support the consideration of dental support as an integral part of palliative care units. [ABSTRACT FROM AUTHOR]

BACKGROUND: Knee osteoarthritis (OA) is a debilitating condition that leads to functional limitations. Self-reported questionnaires and performance-based tests are tools commonly used for measuring physical function. OBJECTIVES: (1) To evaluate the impact of end-stage knee OA on functional outcomes and examine the association between self-reported and performance-based measures of function in patients with end-stage knee osteoarthritis awaiting total knee arthroplasty (2) To explore the interrelationships among pain, strength, and overall physical function in this patient population. METHODS: In this cross-sectional analysis, 33 patients with end-stage knee OA were recruited and completed the knee Outcome Survey-Activities of Daily Living Scale (KOS-ADLS) and executed performance-based tests including the Timed Up and Go, the 30-second chair stand test, and the Stair Climbing Test. Knee pain, and isometric hip and knee strength were evaluated. RESULTS: Patients perceived deficits in their physical functionwith a score of 35/100 on the KOS-ADLS and demonstrated functional limitations in all performed tasks. KOS-ADLs was weakly associated with TUG and 30s-CST (r = - 0.301, p = 0.047, and r = 0.39, p = 0.014. respectively). Knee pain was linked with the KOS-ADL score and GRS score (r = - 0.406, p = 0.010; r = - 0.343, p = 0.027; respectively), while the strength of the affected side was correlated with the performed (p = < 0.001) and reported function outcomes (p = 0.007). CONCLUSION: Participants exhibit declines in both perceived and executed functional abilities. Self-reported and performance-based functional measures are weakly correlated within our study group, highlighting the importance of incorporating both measures in clinical practice for a comprehensive evaluation of physical function. Pain was linked to subjective aspect of physical function, while strength was connected to perceived and performed functional capacity. Implementing a tailored rehabilitation program targeting muscle weakness and pain holds the potential to mitigate functional decline in individuals awaiting total knee arthroplasty (TKA). [ABSTRACT FROM AUTHOR]

This review aims to provide a correlation between oral and oropharyngeal subsites and type of reconstruction used in the management of head and neck cancer patients. A literature search of PubMed, Embase and Web of Science was conducted. All study types describing long-term speech and swallow outcomes of adults following head and neck oncological reconstruction, which used a subsite classification, were included. Risk of bias was assessed using the Robbins-1 tool. A total of 2270 patients were found in 26 studies. The number of subsites/studies ranged from 2 to 18. Subsites were predominantly divided on an anatomical basis. Other classifications included functionally grouped subsites. Seven articles considered combinations, unilateral and bilateral defects. Base of tongue, FOM, and defects crossing the midline are negatively correlated with post-operative speech and swallow. Lateral distributions were associated with superior outcomes. The University of Washington Quality of Life Questionnaire (UW-QOL) was the most prevalent tool for speech and swallow assessment. Other factors that significantly affect speech and swallow outcomes include adjuvant therapy, size, type of reconstruction (free flap compared to pedicled or local). The role of neoadjuvant therapy remains unknown. A consistent and formalised approach including risk stratification for multiple contributing factors would be useful in clinical pre- and post-operative management. [ABSTRACT FROM AUTHOR]

Background: Transition of care from hospitalisation to home is a complex process with potential patient safety risks, especially for patients with multimorbidity. Traditionally, the quality of transition of care has been evaluated primarily through readmission rates. However, interpreting the readmission rates presents challenges, and readmission rates fail to capture the patient's perspective on the quality of the care transition. Insight into the patient's experience with their care or a health service can be provided through the use of patient-reported experience measures (PREMs), and the two PREMs Care Transitions Measure 15 (CTM-15) and Partners at Care Transitions Measure part 1 and 2 (PACT-M1 and PACT-M2) assess on the quality of transition of care from the patients' perspective. The aim of this study was to translate, culturally adapt, and assess content validity of CTM-15, PACT-M1, and PACT-M2 for Danish-speaking patients with multimorbidity. Methods: A two-step approach was used for content validation, involving cognitive debriefing and interviews with patients, representing the target group, as well as quantitative data collection from healthcare professionals representing all three sectors of the Danish healthcare system. The patients were systematically interviewed regarding the aspects of content validity; comprehensibility, relevance, and comprehensiveness. The healthcare professionals assessed the relevance and comprehensiveness of each item through questionnaires, allowing the calculation of a content validity index (CVI). An item CVI ≥ 0.78 is considered good. Results: The results of the qualitative data indicated that both CTM-15 and the PACT-M questionnaires were considered relevant, and comprehensible, and comprehensive to the target group. The CVI computed at item level determined that PACT-M1 and PACT-M2 demonstrated excellent content validity among the healthcare professionals, whereas the CVI for two items of the CTM-15 fell below the threshold value for "good". Conclusion: The Danish versions of the PACT-M questionnaires demonstrated good content validity, and the CTM-15 demonstrated acceptable content validity based on qualitative data from patients and quantitative data from healthcare professionals. Further validation of the questionnaires, by assessing their construct validity and reliability is recommended. Plain English summary: In this study, we aimed to translate two questionnaires, CTM-15 and PACT-M, that address patients' perspectives on the quality of transition of care, into Danish. Furthermore, we assessed their content validity i.e., their relevance, comprehensibility, and comprehensiveness. The study is important because we need to include the patients' experiences in the overall evaluation of transition of care from hospital admission to home. This is possible through validated questionnaires. In order to investigate the content validity, it is important to include representatives of the target group, in this study patients with multimorbidity, as well as professional experts in the area. We interviewed patients about their perception of the relevance, comprehensibility, and comprehensiveness of the questionnaires. Additionally, we asked healthcare professionals about the relevance and comprehensiveness of the questionnaires. PACT-M demonstrated good content validity according to both patients and healthcare professionals. CTM-15 showed good content validity among patients, however, two items were not considered relevant by healthcare professionals. To ensure the usability of the questionnaires, further investigation into their construct validity, reliability, and responsiveness is necessary. Upon completion of the validation process, the questionnaires will be valuable tools in research projects aiming to improve the transition of care, as well as in quality monitoring and improvement initiatives. [ABSTRACT FROM AUTHOR]

Introduction: Salpingitis is caused by ascending microbes from the lower reproductive tract and contributes to tubal factor infertility, ectopic pregnancy, and chronic pelvic pain. The aim of this study was to analyze if the risk for complications and dissatisfaction after hysterectomy and adnexal surgery was increased in women reporting previous salpingitis. Material and methods: This is an observational cohort study including women undergoing gynecologic surgery from 1997 to 2020, registered in the Swedish National Quality Register of Gynecologic Surgery (GynOp). Patient‐reported previous salpingitis was the exposure. Complications up to 8 weeks and satisfaction at 1 year postoperatively were the outcomes. Multivariable logistic regression and ordinal regression were performed. Results were adjusted for potential confounders including age, body mass index, smoking and year of procedure as well as endometriosis and previous abdominal surgery. Multiple imputation was used to handle missing data. Results: In this study, 61 222 women were included, of whom 5636 (9.2%) women reported a previous salpingitis. There was an increased risk for women reporting previous salpingitis in both the unadjusted and fully adjusted models to have complications within 8 weeks of surgery (adjusted odds ratio [aOR] 1.22, 95% confidence interval [CI] 1.14–1.32). The highest odds ratios were found for bowel injury (aOR 1.62, 95% CI 1.29–2.03), bladder injury (aOR 1.52, 95% CI 1.23–1.58), and postoperative pain (aOR 1.37, 95% CI 1.22–1.54). Women exposed to salpingitis were also more likely to report a lower level of satisfaction 1 year after surgery compared with unexposed women (aOR 0.87, 95% CI 0.81–0.92). Conclusions: Self‐reported salpingitis appears to be a risk factor for complications and dissatisfaction after gynecologic surgery. This implies that known previous salpingitis should be included in the risk assessment before gynecologic procedures. [ABSTRACT FROM AUTHOR]

Purpose: Head and neck cancer (HNC) patients often suffer from shame and stigma due to treatment limitations or due to societal factors. The purpose of this study was to assess perceived body image, depression, physical and psychosocial function, and self-stigma, as well as to identify factors that predicted shame and stigma in patients with HNC. Methods: This cross-sectional study recruited 178 HNC patients from the outpatient radiation department of a medical center in Northern Taiwan. Patients were assessed for patient reported outcomes using the Body Image Scale (BIS), the Hospital Anxiety and Depression Scale–Depression Subscale (HADS–Depression Subscale), the University of Washington Quality of Life Scale (UW-QOL) version 4.0, and the Shame and Stigma Scale (SSS). Data were analyzed by descriptive analysis, Pearson’s product-moment correlation, and multiple regression. Results: The two top-ranked subscales of shame and stigma were: “speech and social concerns” and “regret”. Shame and stigma were positively correlated with a longer time since completion of treatment, more body image concerns, and higher levels of depression. They were negatively correlated with being male and having lower physical function. Multiple regression analysis showed that female gender, a longer time since completing treatment, higher levels of body image concern, greater depression, and less physical function predicted greater shame and stigma. These factors explained 74.7% of the variance in shame and stigma. Conclusion: Patients’ body image concerns, depression, time since completing treatment, and physical function are associated with shame and stigma. Oncology nurses should assess and record psychological status, provide available resources, and refer appropriate HNC patients to counselling. [ABSTRACT FROM AUTHOR]

Purpose: Patients with relapse and/or refractory multiple myeloma (RRMM) have a high disease burden with poor health-related quality of life (HRQoL) which worsens with each additional relapse. We aimed to review the impact of triplet, doublet, monotherapies, and salvage autologous stem cell transplantation on the HRQoL of RRMM patients. Methods: We performed a comprehensive literature search of Medline/PubMed, Wiley Cochrane Library, EMBASE, Scopus, CINAHL, and Clinicaltrials.gov to identify clinical studies in RRMM patients with HRQoL as an outcome measure. The ISOQoL and CONSORT-PRO extension guidelines were used to assess the quality of HRQoL reporting. We synthesized the result using a qualitative analysis. Results: A total of 10,245 RRMM patients enrolled in 28 eligible studies received either a triplet, doublet regimen, monotherapy, or salvage autologous stem cell transplantation. The EORTC QLQ-C30 was the most used questionnaire, and compliance with HRQoL reporting standards is generally poor among studies without an additional HRQoL publication. Most of the current therapeutic options are at best able to maintain HRQoL at baseline but not improve it. The methodological and reporting heterogeneity among the studies complicates generalizations. Conclusions: Many of the current treatment regimens for RRMM have demonstrated clinical effectiveness in trials. Unlike newly diagnosed MM, these regimens are less likely to result in significant improvement in HRQoL in RRMM. This should be communicated to patients before initiating therapies. Implications for Cancer Survivors: Individualized therapeutic approach for RRMM should be chosen based on a shared decision-making process that aligns clinical efficacy with patients' treatment priorities and HRQoL. [ABSTRACT FROM AUTHOR]

BackgroundThe algorithmic patient preference predictor (PPP) has been proposed to aid in decision making for incapacitated patients in the absence of advanced directives. Ethical and legal challenges aside, multiple practical barriers exist for building a personalized PPP. Here, we examine previous work using machine learning to predict patient reported outcome measures (PROMs) for capacitated patients undergoing diverse procedures, therapies, and life events. Demonstrating robust performance in predicting PROMs for capacitated patients could suggest opportunities for developing a model tailored to incapacitated ones.MethodsWe performed a scoping review of PubMed, Embase, and Scopus using the PRISMA-ScR guidelines to capture studies using machine learning to predict PROMs following a medical event alongside qualitative studies exploring a theoretical PPP.ResultsSixty-eight studies used machine learning to evaluate PROMs; an additional 20 studies focused on a theoretical PPP. For PROMs, orthopedic surgeries (n = 33) and spinal surgeries (n = 12) were the most common medical event. Studies used demographic (n = 30), pre-event PROMs (n = 52), comorbidities (n = 29), social determinants of health (n = 30), and intraoperative variables (n = 124) as predictors. Thirty-four different PROMs were used as the target outcome. Evaluation metrics varied by task, but performance was overall poor to moderate for the best reported scores. In models that used feature importance, pre-event PROMs were the most predictive of post-event PROMs. Fairness assessments were rare (n = 6). These findings reinforce the necessity of the integrating patient values and preferences, beyond demographic factors, to improve the development of personalized PPP models for incapacitated patients.ConclusionThe primary objective of a PPP is to estimate patient-reported quality of life following an intervention. Use of machine learning to predict PROMs for capacitated patients introduces challenges and opportunities for building a personalized PPP for incapacitated patients without advanced directives.

Abstract Loss of ambulation is common and highly variable in Parkinson’s disease (PD), and poorly understood from the perspectives of those with PD. Gaining insights to the anticipated perceived trajectories and their drivers, will facilitate patient-centered care. Latent class growth analysis, a person-centered mixture modelling approach, was applied to 16,863 people with PD stratified by early (N = 8612; 10 years) disease to discern clusters with similar longitudinal patterns of self-reported walking difficulty, measured by EuroQoL 5D-5L that is validated for use in PD. There were four clusters in early and mid-disease strata, with a fifth identified in later disease. Trajectories ranged from none to moderate walking difficulty, with small clusters with severe problems. The percentage of subjects with moderate (early = 17.5%, mid = 26.4%, later = 32.5%) and severe (early = 3.8%, mid = 7.4%, later = 15.4%) walking difficulty at baseline increased across disease duration groups. The trajectories tended to be stable with variability in moderate and severe groups. Across strata, clusters with moderate to severe problems were associated with more severe impairment, depression, anxiety, arthritis, higher BMI, lower income, and lower education, but no consistent race or gender differences. The findings reveal distinct longitudinal patterns in perceived difficulties in walking in PD.

Abstract Background Patient-Reported Outcome Measures (PROM) provide important information, however, missing PROM data threaten the interpretability and generalizability of findings by introducing potential bias. This study aims to provide insight into missingness mechanisms and inform future researchers on generalizability and possible methodological solutions to overcome missing PROM data problems during data collection and statistical analyses. Methods We identified 10,236 colorectal cancer survivors (CRCs) above 18y, diagnosed between 2014 and 2018 through the Danish Clinical Registries. We invited a random 20% (2,097) to participate in a national survey in May 2023. We distributed reminder e-mails at day 10 and day 20, and compared Initial Responders (response day 0–9), Subsequent Responders (response day 10–28) and Non-responders (no response after 28 days) in demographic and cancer-related characteristics and PROM-scores using linear regression. Results Of the 2,097 CRCs, 1,188 responded (57%). Of these, 142 (7%) were excluded leaving 1,955 eligible CRCs. 628 (32%) were categorized as initial responders, 418 (21%) as subsequent responders, and 909 (47%) as non-responders. Differences in demographic and cancer-related characteristics between the three groups were minor and PROM-scores only marginally differed between initial and subsequent responders. Conclusion In this study of long-term colorectal cancer survivors, we showed that initial responders, subsequent responders, and non-responders exhibit comparable demographic and cancer-related characteristics. Among respondents, Patient-Reported Outcome Measures were also similar, indicating generalizability. Assuming Patient-Reported Outcome Measures of subsequent responders represent answers by the non-responders (would they be available), it may be reasonable to judge the missingness mechanism as Missing Completely At Random.

Loss of ambulation is common and highly variable in Parkinson’s disease (PD), and poorly understood from the perspectives of those with PD. Gaining insights to the anticipated perceived trajectories and their drivers, will facilitate patient-centered care. Latent class growth analysis, a person-centered mixture modelling approach, was applied to 16,863 people with PD stratified by early (N = 8612; < 3 years), mid (N = 6181; 3–10 years) and later (N = 2070; > 10 years) disease to discern clusters with similar longitudinal patterns of self-reported walking difficulty, measured by EuroQoL 5D-5L that is validated for use in PD. There were four clusters in early and mid-disease strata, with a fifth identified in later disease. Trajectories ranged from none to moderate walking difficulty, with small clusters with severe problems. The percentage of subjects with moderate (early = 17.5%, mid = 26.4%, later = 32.5%) and severe (early = 3.8%, mid = 7.4%, later = 15.4%) walking difficulty at baseline increased across disease duration groups. The trajectories tended to be stable with variability in moderate and severe groups. Across strata, clusters with moderate to severe problems were associated with more severe impairment, depression, anxiety, arthritis, higher BMI, lower income, and lower education, but no consistent race or gender differences. The findings reveal distinct longitudinal patterns in perceived difficulties in walking in PD. [ABSTRACT FROM AUTHOR]

Background: Patient-Reported Outcome Measures (PROM) provide important information, however, missing PROM data threaten the interpretability and generalizability of findings by introducing potential bias. This study aims to provide insight into missingness mechanisms and inform future researchers on generalizability and possible methodological solutions to overcome missing PROM data problems during data collection and statistical analyses. Methods: We identified 10,236 colorectal cancer survivors (CRCs) above 18y, diagnosed between 2014 and 2018 through the Danish Clinical Registries. We invited a random 20% (2,097) to participate in a national survey in May 2023. We distributed reminder e-mails at day 10 and day 20, and compared Initial Responders (response day 0–9), Subsequent Responders (response day 10–28) and Non-responders (no response after 28 days) in demographic and cancer-related characteristics and PROM-scores using linear regression. Results: Of the 2,097 CRCs, 1,188 responded (57%). Of these, 142 (7%) were excluded leaving 1,955 eligible CRCs. 628 (32%) were categorized as initial responders, 418 (21%) as subsequent responders, and 909 (47%) as non-responders. Differences in demographic and cancer-related characteristics between the three groups were minor and PROM-scores only marginally differed between initial and subsequent responders. Conclusion: In this study of long-term colorectal cancer survivors, we showed that initial responders, subsequent responders, and non-responders exhibit comparable demographic and cancer-related characteristics. Among respondents, Patient-Reported Outcome Measures were also similar, indicating generalizability. Assuming Patient-Reported Outcome Measures of subsequent responders represent answers by the non-responders (would they be available), it may be reasonable to judge the missingness mechanism as Missing Completely At Random. [ABSTRACT FROM AUTHOR]

Purpose: To compare clinical outcomes and the rate of return to sport among patients that have undergone minimally invasive repair versus open approach of an acute Achilles tendon rupture. Methods: Patients who underwent surgical repair of acute Achilles tendon rupture at a single urban academic institution from 2017 to 2020 with minimum 2-year follow-up were reviewed retrospectively. Preinjury sport participation and preinjury work activity information, the Achilles tendon Total Rupture Score (ATRS), the Tegner Activity Scale, Patient-Reported Outcomes Measurement Information System for mobility and pain interference were collected. Results: In total, 144 patients were initially included in the study. Of these, 63 patients were followed with a mean follow-up of 45.3 ± 29.2 months. The mean operative time did not significantly differ between groups (p = 0.938). Patients who underwent minimally invasive repair returned to sport at a rate of 88.9% at a mean of 10.6 ± 5.8 months, compared to return rate of open procedures of 83.7% at 9.5 ± 5.5 months. There were no significant differences in ATRS (p = 0.246), Tegner (p = 0.137) or VAS pain (p = 0.317) scores between groups. There was no difference in cosmetic satisfaction between PARS and open repair groups (88.4 vs. 76.0; p = 0.244). Conclusion: Patients who underwent minimally invasive repair of acute Achilles tendon ruptures demonstrate no significant differences with respect to cosmesis, operative time, patient-reported outcomes and the rate and level of return to activities when compared to an open approach. Level of evidence: III. [ABSTRACT FROM AUTHOR]

Introduction: The Patient Reported Outcomes, Burdens, and Experiences (PROBE) questionnaire is a patient‐reported outcome tool that assesses quality of life and disease burden in people with haemophilia (PWH). Aim: To assesses the test–retest reliability of PROBE when completed using the mobile phone application. Methods: We recruited PWH, including carriers, and individuals with no bleeding disorders who attended haemophilia‐related workshops or via social media. Participants completed PROBE three times (twice on the app: T1 and T2, and once on the web, T3). Test–retest reliability was analysed for T1 versus T2 (app to app, time period one) and T2 versus T3 (app to web, time period two). Results: We enrolled 48 participants (median age = 56 [range 27–78] years). Eighteen participants (37.5%) were PWH and seven (14.6%) were carriers. On general health domain questions, we found almost perfect agreement, except for a question on the frequency of use of pain medication in the last 12 months [Kappa coefficient (κ).72 and.37 for time period one and two, respectively] and any use of pain medications (κ.75) for time period two. For haemophilia‐related questions, we found substantial to perfect agreement, except for the questions on the number of joint bleeds in the previous 6 months for time period one (κ.49) and the number of bleeds in the previous two weeks for time period two (κ.34). Conclusions: The results demonstrate the reliability of the PROBE app. The app can be used interchangeably with the paper and web platforms for PROBE administration. [ABSTRACT FROM AUTHOR]

Background: In recognition of the distinct clinical challenges and research gaps in young breast cancer (YBC) patients, we established the Comprehensive Young Age Breast Cancer (CHARM) registry to collect prospective data. Methods: This prospective cohort included patients who were newly diagnosed with histologically confirmed breast cancer without prior treatment at the Samsung Medical Center (SMC) in April 2013. We included patients who were either 40 years old or younger at the time of diagnosis, pregnant at breast cancer diagnosis or diagnosed with breast cancer within 1 year of delivery. All data were collected using Medidata's Rave Electronic Data. Clinical data were obtained from electronic medical records. Two experienced pathologists reviewed the pathologic data. Bone mineral densitometry tests have been conducted annually. To obtain multi-omics data, tumor tissues and blood samples were prospectively collected from consenting patients in the registry during surgery. The fertility-related factor also collected collaborated with the Department of Obstetrics and Gynecology. Anti-Müllerian hormone, estradiol, follicle-stimulating hormone, and luteinizing hormone levels were measured using an additional blood sample from baseline to last follow-up. Patient-reported outcomes were assessed using mobile questionnaires. Results: A total of 1868 participants were included in the SMC YBC study. The average (standard deviation) age was 35.57 (3.79) and 99.8% of the participants were premenopausal. Among them, 1062 participants completed the PRO questionnaires. Conclusions: The SMC YBC cohort serves as a comprehensive registry for YBC to optimize care and improve knowledge regarding the management of YBC. [ABSTRACT FROM AUTHOR]

Introduction: The use of patient-reported outcomes (PROs) has been shown to enhance the accuracy of symptom collection and improve overall survival and quality of life. This is the first study comparing concordance and patient preference for two PRO tools: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) and the adapted-REQUITE Lung Questionnaire. Materials and Methods: Patients with lung cancer were recruited to the study while attending outpatient clinics at a tertiary cancer centre. Clinician-reported outcomes were generated through initial patient assessment with CTCAE v4.03. Participants then completed the PRO-CTCAE® and adapted-REQUITE questionnaires. Concordance between the 2 questionnaires was assessed by calculating Pearson correlation coefficient. PRO-CTCAE® and CTCAE concordance was demonstrated by calculating Pearson correlation coefficient from the linear predictors of an ordinal logistic regression. P-values were also calculated. Results: Out of 74 patients approached, 65 provided written informed consent to participate in the study. 63 (96.9%) patients completed both PRO-CTCAE® and adapted-REQUITE questionnaires. Pearson correlation coefficient between PRO tools was 0.8-0.83 (p <.001). Correlation between CTCAE and PRO-CTCAE® ranged between 0.66-0.82 (p <.001). Adapted-REQUITE and CTCAE correlation was higher for all symptoms ranging between 0.79-0.91 (p <.001). Acceptable discrepancies within one grade were present in 96.8%-100% of symptom domains for REQUITE and in 92.1%-96.8%for all domains in the PRO-CTCAE®. 54% of the total participant cohort favored the adapted-REQUITE questionnaire due to reduced subjectivity in the questions and ease of use. Conclusion: The adapted-REQUITE questionnaire has shown a superior correlation to clinician-reported outcomes and higher patient preference than the PRO-CTCAE®. The results of this study suggest the use of the REQUITE questionnaire for patients with lung cancer in routine clinical practice. [ABSTRACT FROM AUTHOR]

Introduction: The objective of the study was to provide long‐term clinical outcomes and complications in the severely atrophic edentulous maxillae treated by means of the quad zygoma protocol (QZP) using the Anatomy‐Guided Approach (AGA). Methods: This was a retrospective cohort study of all consecutive patients with severely atrophic edentulous maxilla and insufficient bone height and width in the anterior and posterior regions bilaterally, who underwent rehabilitation with the QZP between May 2006 and December 2021. All patients were followed for at least 1 year. All zygomatic implants (ZIs) were placed by the same surgeon. The primary endpoint of the study was the implant survival rate. Secondary endpoints were implant success rate, prosthesis success rate, complications, and Oral Health‐Related Quality of Life using the OHIP‐14 questionnaire. Results: A total of 56 patients (men 16, women 40) with 224 ZIs (Nobel Biocare, n = 204; Straumann, n = 16; Southern Implant, n = 4) placement were included with a mean follow‐up period 8.8 ± 3.9 years (range, 1.2–17.0). The survival (success) rate was 97.7%. Five ZIs in four patients failed. The mean time between implant placement and failure was 8.6 years (range, 0.5–13.3). All patients received immediate loading with acrylic prosthesis. The successful rates for the definitive prosthesis were 98.2%. Forty‐two patients received posterior cantilever for rehabilitation of fixed definitive prosthesis. Local orofacial inflammation (35.7%) and Sinusitis (12.5%) were the most common complications, occurring at a mean follow‐up of 10.0 (range, 4.2–14.9) and 10.3 (range, 4.3–16.2) years, respectively. In 48 patients, the mean score of the OHIP‐14 questionnaire was 1.7 ± 2.6 with the follow‐up period of 9.0 ± 4.1 years. Conclusions: The rehabilitation of severely atrophic edentulous maxilla using the QZP has shown a predictable and high survival rate in the long term. The implementation of an immediate loading protocol offers potential benefits in stabilizing ZIs with cross‐arch stabilization. Moreover, the use of a posterior cantilever in reconstruction can effectively establish functional occlusion through well‐distributed ZIs, eliminating the need for additional implant placement. [ABSTRACT FROM AUTHOR]

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.

Purpose: Attempts have been made to enhance knee prostheses design to improve clinical outcomes including bi-cruciate stabilized (BCS) TKA design and single-radius (SR) femoral component design. The complication rate of first generation BCS (fBCS) TKA was higher than that of standard TKA. Regarding BCS TKA, modification of the fBCS TKA system to the second-generation BCS (sBCS) TKA system was performed to avoid complications. This study aimed to compare the midterm clinical results of sBCS TKA and SR TKA. Methods: We retrospectively reviewed data from TKA patients. A total of 142 patients who were followed up for at least 5 years were enrolled: 61 TKAs using sBCS and 81 TKAs using the posterior stabilized (PS) single-radius (SR) design. The clinical results at 6 months, 2 years, and 5 years postoperatively were compared between the sBCS and SR PS groups. Results: At 6 months postoperatively, the maximum flexion angle (MFA) of the sBCS group was larger than that of the SR PS group. At 2 years, MFA, KOOS subscales of pain and ADL in the sBCS group were better and at 5 years, the MFA, KOOS subscales of pain and QOL in the sBCS group were better than those in the SR group. There was no significant differences of the ratios of complications and revision surgeries between the two groups. Conclusion: The midterm clinical results of sBCS TKA were better than those of SR PS TKA in terms of the MFA and KOOS subscales of pain and QOL.

Both the cruciate-retaining (CR) and posterior-stabilized (PS) implant systems are commonplace in modern total knee arthroplasty (TKA) practice. However, there is controversy regarding functional outcomes and survivorship. The aim of the underlying study was to evaluate differences between CR and PS TKA regarding knee function, patient-reported outcome measures (PROMs) as well as complication rates. 140 patients with knee osteoarthritis scheduled for an unconstrained TKA were enrolled in a prospective, randomized study. Patients received either a CR or PS implant. Range of motion and PROMs (Oxford Knee Score, Knee Society Score, European Quality of Life 5 Dimensions 3 Level, University of California Los Angeles Activity scale and subjective satisfaction) were assessed prior to, 3 months, 1 and 2 years after surgery. We found minor differences between treatment groups regarding demographic factors. Within the PS group duration of surgery was longer (mean PS 81.4 min vs CR 76.0 min, P =.006). We observed better flexion (median PS 120.0° vs CR 115°, P =.017) and an overall better range of motion (median PS 120.0° vs CR 115.0°, P =.008) for the PS group. PROMs did not differ between groups. At 2-year follow-up there were no revisions in either cohort. Five patients needed reoperations. Three patients needed manipulation under anesthesia, 2 in the CR and one in the PS group. While PS TKA achieved a better flexion capability, PROMs were similar in CR and PS TKA. The CR implant design continues to be a reliable option for patients with an intact posterior cruciate ligament. [ABSTRACT FROM AUTHOR]

Objective: To define and characterize extreme phenotypes based on perceived improvement in pain for persons with chronic pain following traumatic brain injury (TBI). Setting: Eighteen Traumatic Brain Injury Model System (TBIMS) Centers. Participants: A total of 1762 TBIMS participants 1 to 30 years post-injury reporting chronic pain at their most recent follow-up interview. Primary Measures: The Patient’s Global Impression of Change (PGIC) related to pain treatment. Sociodemographic, injury, functional outcome, pain, and pain treatment characteristics. Results: Participants were mostly male (73%), White (75%), middle-aged (mean 46 years), injured in motor vehicle accidents (53%), or falls (20%). Extreme phenotypes were created for an extreme improvement phenotype (n = 512, 29.8%) defined as “moderately better” or above on the PGIC and an extreme no-change group (n = 290, 16.9%) defined as no change or worse. Least absolute shrinkage and selection operator (LASSO) regression combined with logistic regression identified multivariable predictors of improvement versus no-change extreme phenotypes. Higher odds of extreme improvement phenotype were significantly associated with being female (odds ratio [OR] = 1.85), married versus single (OR = 2.02), better motor function (OR = 1.03), lower pain intensity (OR = 0.78), and less frequent pain, especially chest pain (OR = 0.36). Several pain treatments were associated with higher odds of being in the extreme improvement versus no-change phenotypes including pain medication (OR = 1.85), physical therapy (OR = 1.51), yoga (OR = 1.61), home exercise program (OR = 1.07), and massage (OR = 1.69). Conclusion: Investigation of extreme phenotypes based on perceived improvement with pain treatment highlights the ability to identify characteristics of individuals based on pain treatment responsiveness. A better understanding of the biopsychosocial characteristics of those who respond and do not respond to pain treatments received may help inform better surveillance, monitoring, and treatment. With further research, the identification of risk factors (such as pain intensity and frequency) for treatment response/nonresponse may provide indicators to prompt changes in care for individuals with chronic pain after TBI. [ABSTRACT FROM AUTHOR]

IntroductionThe use of patient-reported outcomes (PROs) has been shown to enhance the accuracy of symptom collection and improve overall survival and quality of life. This is the first study comparing concordance and patient preference for two PRO tools: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) and the adapted-REQUITE Lung Questionnaire.Materials and MethodsPatients with lung cancer were recruited to the study while attending outpatient clinics at a tertiary cancer centre. Clinician-reported outcomes were generated through initial patient assessment with CTCAE v4.03. Participants then completed the PRO-CTCAE® and adapted-REQUITE questionnaires. Concordance between the 2 questionnaires was assessed by calculating Pearson correlation coefficient. PRO-CTCAE® and CTCAE concordance was demonstrated by calculating Pearson correlation coefficient from the linear predictors of an ordinal logistic regression. P-values were also calculated.ResultsOut of 74 patients approached, 65 provided written informed consent to participate in the study. 63 (96.9%) patients completed both PRO-CTCAE® and adapted-REQUITE questionnaires. Pearson correlation coefficient between PRO tools was 0.8-0.83 (p

Introduction: Self-perceived health status data is usually collected using patient-reported outcome measures. Information from the patients’ perspective is one of the important components in planning person-centred care. The study aimed to compare EQ-5D-5L in survivors after out-of-hospital cardiac arrest (OHCA) with data for Norwegian population controls. Secondary aim included comparing characteristics of respondents and non-respondents from the OHCA population. Methods: In this cross-sectional survey, 714 OHCA survivors received an electronic EQ-5D-5L questionnaire 3–6 months following OHCA. EQ-5D-5L assesses for five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with five-point descriptive scales and overall health on a visual analogue scale from 0 (worst) to 100 (best) (EQ VAS). Results are used to calculate the EQ index ranging from −0.59 (worst) to 1 (best). Patient responses were matched for age and sex with existing data from controls, collected through a postal survey (response rate 26%), and compared with Chi-square tests or t-tests as appropriate. Results: Of 784 OHCA survivors, 714 received the EQ-5D-5L, and 445 (62%) responded. Respondents had higher rates of shockable first rhythm and better cerebral performance category scores than the non-respondents. OHCA survivors reported poorer health compared to controls as assessed by EQ-5D-5L dimensions, the EQ index (0.76 ± 0.24 vs 0.82 ± 0.18), and EQ VAS (69 ± 21 vs 79 ± 17), except for the pain/discomfort dimension. Conclusions: Norwegian OHCA survivors reported poorer health than the general population as assessed by the EQ-5D-5L. PROMs use in this population can be used to inform follow-up and health care delivery.

Background: Decompression for lumbar spinal stenosis (LSS) is the most frequently performed spine surgery in Denmark. According to the Danish spine registry DaneSpine, at 1 year after surgery, about 75% of patients experiences considerable pain relief and around 66% improvement in quality of life. However, 25% do not improve very much. We have developed a predictive decision support tool, PROPOSE. It is intended to be used in the clinical conversation between healthcare providers and LSS patients as a shared decision-making aid presenting pros and cons of surgical intervention. This study presents the development and evaluation of PROPOSE in a clinical setting. Methods: For model development, 6.357 LSS patients enrolled in DaneSpine were identified. For model validation, predictor response and predicted outcome was collected via PROPOSE from 228 patients. Observed outcome at 1 year was retrieved from DaneSpine. All participants were treated at 3 Danish spine centers. The outcome measures presented are improvement in walking distance, the Oswestry Disability Index, EQ-5D-3L and leg/back pain on the Visual Analog Scale. Outcome variables were dichotomized into success (1) and failure (0). With the exception of walking distance, a success was defined as reaching minimal clinically important difference at 1-year follow-up. Models were trained using Multivariate Adaptive Regression Splines. Performance was assessed by inspecting confusion matrix, ROC curves and comparing GCV (generalized cross-validation) errors. Final performance of the models was evaluated on independent test data. Results: The walking distance model demonstrated excellent performance with an AUC of 0.88 and a Brier score of 0.14. The VAS leg pain model had the lowest discriminatory performance with an AUC of 0.67 and a Brier score of 0.22. Conclusions: PROPOSE works in a real-world clinical setting as a proof of concept and demonstrates acceptable performance. It may have the potential of aiding shared decision making.

Chronic limb-threatening ischemia (CLTI) causes significant morbidity with profound negative effects on health-related quality of life. As the prevalence of peripheral artery disease and diabetes continue to rise in our aging population, the public health impact of CLTI has escalated. Patient-reported outcome measures (PROMs) have become common and important measures for clinical evaluation in both clinical care and research. PROMs are important for the measurement of clinical effectiveness and cost effectiveness and for shared decision-making on treatment options. However, the PROMs used to describe the experience of patients with CLTI are heterogeneous, incomplete, and lack specific applicability to the underlying disease processes and diverse populations. For example, certain PROMs exist for patients with extremity wounds, and other PROMs exist for patients with pain, and still others exist for patients with vascular disease. Despite this multiplicity of tools, no single PROM encompasses all of the components necessary to describe the experiences of patients with CLTI. This significant unmet need is evident from both published reports and contemporary large-scale clinical trials in the field. In this systematic review, we review the current use of PROMs for patients with CLTI in clinical practice and in research trials and highlight the gaps that need to be addressed to develop a unifying PROM instrument for CLTI.

Abstract Background Gait impairment is a relevant problem in persons with multiple sclerosis (pwMS). The Multiple Sclerosis Walking Scale 12 (MSWS-12) is a valid Patient Reported Outcome Measure (PROM) to evaluate walking ability in pwMS. The aim of this study was to provide a linguistically valid translation of MSWS-12 into German language (MSWS-12/D) and to evaluate its psychometric properties. Methods The MSWS-12 was translated in a process modified from guidelines for the cross-cultural adaption of PROMs, and a pre-test was applied in a small sample of 20 pwMS to evaluate comprehensibility and acceptance. Psychometric properties (floor and ceiling effects, internal consistency, construct validity) were then assessed in 124 pwMS seen at academic MS centers. Construct validity was evaluated against Expanded Disability Status Scale (EDSS) and maximum gait speed in the Timed 25-Foot Walk (T25FW). Results Although the sample covered a wide spectrum of symptom severity, the majority had rather low levels of disability (EDSS median 2.0) and 6.5% scored EDSS of 0. In this sample, MSWS-12/D showed floor effects (36% with score 0) and for internal consistency, a Cronbach’s alpha of 0.98 was calculated. MSWS-12/D score showed a relevant correlation to EDSS (ρ = 0.73) and T25FW speed (r=-0.72). Conclusion We provide MSWS-12/D as a linguistically valid German version of MSWS-12. Psychometric properties (acceptance, floor and ceiling effects, internal consistency and construct validity) in pwMS were similar to those described for the original version. This indicates that MSWS-12/D can be applied as equivalent to the original version in German speaking pwMS. Results support the relevance of PROMs to capture patient perception of walking ability in addition to performance-based assessments such as maximum walking speed or maximum walking distance.

BackgroundImpairment of bowel, urogenital and fertility-related function in patients treated for rectal cancer is common. While the rate of rectal cancer in the young (

Aim: To compare health-related quality of life (HRQoL) in young survivors of out-of-hospital cardiac arrest (OHCA) in Norway with an age and sex-matched reference population and to assess the associations between exercise volume prior to OHCA and HRQoL after. Methods: We present data from survivors aged 18–50 years registered with OHCA in the Norwegian Cardiac Arrest Registry between January 1st 2015 and December 31st 2017. Survivors were invited to answer two questionnaires; (1) the Short Form 36 (SF-36) Health Survey Version 1, and (2) about exercise habits prior to OHCA. Respondents were randomly matched 1:1 for age and sex with a reference population (data were available from the Norwegian Centre for Research Data). Results: Of the 175 survivors invited, 95 (54%) responded, median age was 44 (range 35–48) years, 26 (27%) females. Valid results for SF-36 were available for 91 survivors, of whom 87 reported pre-OHCA exercise-volume. Prior to OHCA, 21 did no regular exercise, 44 exercised 1–4 hours/week and 22 exercised ≥5 hours/week. Compared to the reference population survivors had significantly (p

Objective: Tinnitus assessment and outcome measurement are complex, as tinnitus is a purely subjective phenomenon. Instruments used for the outcome measurement of tinnitus in the context of clinical trials include self-report questionnaires, visual analogue or numeric rating scales and psychoacoustic measurements of tinnitus loudness. For the evaluation of therapeutic interventions, it is critical to know which changes in outcome measurement instruments can be considered as clinically relevant. For this purpose, the concept of the minimal clinically important difference (MCID) has been introduced. Study design: Here we performed a literature research in PubMed in order to identify for which tinnitus outcome measurements MCID criteria have been estimated and which of these estimates fulfil the current methodological standards and can thus be considered as established. Results: For most, but not all tinnitus outcome instruments, MCID calculations have been performed. The MCIDs for the Tinnitus Handicap Inventory (THI), the Tinnitus Questionnaire (TQ), the Tinnitus Functional Index (TFI) and visual analogue scales (VAS) vary considerably across studies. Psychoacoustic assessments of tinnitus such as loudness matching have not shown sufficient reliability and validity for the use as an outcome measurement. Conclusion: Future research should aim at the confirmation of the available estimates in large samples involving various therapeutic interventions and under the consideration of time intervals and baseline values. As a rule of thumb, an improvement of about 15% can be considered clinically meaningful, analogous to what has been seen in other entirely subjective pathologies like chronic pain. [ABSTRACT FROM AUTHOR]