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Purpose Adherence to oral anticancer treatments (OATs) is a critical issue in metastatic breast cancer (MBC) to enhance survivorship and quality of life. The study is aimed to analyze the main themes and attributes related to OATs in MBC patients. This research is part of a project titled “ Enhancing Therapy Adherence Among Metastatic Breast Cancer Patients \" designed to produce a predictive model of non-adherence, a decision support system, and guidelines to improve adherence to OATs. Methods The study consists of an exploratory observational and qualitative analysis using a focus group method. A semi-structured interview guide was developed to handle relevant OAT themes. Wordcloud plots, network analysis, and sentiment analysis were performed. Results Nineteen female MBC patients participated in the protocol (age mean 55.95, SD  = 6.87). Four main themes emerged: (theme 1) individual clinical pathway; (theme 2) barriers to adherence; (theme 3) resources to adherence; (theme 4) patients’ perception of new technologies. The Wordcloud and network analysis highlighted the important role of treatment side effects and the relationship with the clinician in the modulation of adherence behavior. This result is consistent with the sentiment analysis underscoring patients experience fear of issues related to clinical values and ineffective communication and discontinuity of the doctor in charge of the patient care. Conclusion The study highlighted the key role of the individual, relational variables, and side effects as internal and external determinants influencing adherence to MBC. Finally, the opportunity offered by e Health technology to connect with other patients with similar conditions and share experiences could be a relief for MBC patients.

Background European cancer programmes and policies lack a unified health-related quality of life (HRQoL) assessment tool. The European oncology quality of life toolkit (EUonQoL-Kit) is a novel set of HRQoL questionnaires, co-designed with cancer patients and survivors, translated and culturally adapted into 31 European languages, and with both static and dynamic electronic administration modes. The main aim of this study is the psychometric assessment of the static version. Secondary aims include evaluating the EUonQoL-Kit acceptability, cross-validating the administration modes, exploring individual factors potentially affecting HRQoL and HRQoL inequalities between countries. Methods A sample of 4,500 participants, including three groups (active treatment, survivors, and palliative care) from 45 centres in 25 EU Member States and 7 associated countries, will be enrolled in a multicentre observational cross-sectional study. All participants will complete the static EUonQoL-Kit; three subsamples (each 10% of the total sample) will also respectively complete the following: a) dynamic EUonQoL-Kit, based on Item Response Theory (IRT)/Computer Adaptive Testing (CAT), b) FACT-G and EQ-5L-5D, and c) static EUonQoL-Kit (re-test). Psychometric analyses will encompass exploratory and confirmatory factor analyses (measurement model and structural validity), Cronbach's alpha (internal consistency), intraclass correlation coefficient (test–retest reliability), Pearson/Spearman correlation (concurrent validity), comparison of group scores (construct validity), and Differential Item Functioning (cross-country item equivalence). Secondary analyses will evaluate participant response time and rate, and static/dynamic score differences. Regression models will estimate associations between individual factors and HRQoL. Discussion The EUonQoL-Kit will serve to systematically incorporate patient perspectives into European cancer policies and to address HRQoL inequalities across Europe. Trial registration ClinicalTrials.gov Identifier: NCT05947903, 2023–06-28.

Introduction Patients with cancer may overestimate their ability to adhere to oral anticancer treatments (OAT) which may significantly reduce adherence rates. However, only few studies have investigated the specific role of personality traits and cognitive distortions in the definition of the adherence trajectory in the cancer field. Methods This study is nested in the Pfizer project (65080791), and it is a secondary, observational analysis of prospectively collected data from a randomized controlled trial (RCT). To avoid potential bias from comparing measurements across different time points, we limited the evaluation of associations among variables to the baseline data. 94 metastatic breast cancer (MBC) patients (mean age 56.8) receiving OAT for MBC have been enrolled. Each participant filled a set of measures assessing personality (Big Five), adherence (AAI-28 and MMAS-8) (© 2006 Donald E Morisky), and optimistic bias (VAS), and Quality of Life (EORTC QLQ-C30 and EORTC QLQ-BR23). Results A discrepancy between self-oriented and other-oriented evaluation of the capacity to take the therapy in the doses, frequencies, and times prescribed was observed (P < 0.001). A negative association between adherence rate and the self-perception of treatment adherence was identified (P < 0.001). Further, conscientiousness correlated positively with the perception of risk to their own health (P = 0.034), and negative association between extraversion and self-perception of treatment adherence (P = 0.05) and between agreeableness and self-perception of treatment adherence have been observed (P = 0.029). Conclusions Our findings suggest that optimistic bias and personality may contribute to shaping adherence in MBC patients. Personality traits influence adherence both directly, by increasing the perception of health risks, and indirectly, by influencing coping strategies and emotion regulation. MBC patients having an OB may underestimate the important side effects and physical comorbidities, as well as difficulties in the daily management and adjustment of therapy due to disease progression.

Purpose. To evaluate the effect of preoperative comorbidity status (defined by the Deyo index) on hospital mortality, postoperative complications, length of hospital stay, and hospital costs for shoulder arthroplasty patients. Methods. The overall mean hospital mortality and postoperative complication rates, and length of hospital stay and hospital costs stratified by the Deyo score were compared using the Pearson Chi squared test and the F-test, respectively. The effects of the Deyo score on hospital mortality and postoperative complications were estimated using multiple logistic regression. The length of hospital stay and hospital costs were estimated using multiple linear regression. The magnitude of the estimated effects of the Deyo score on the 4 outcomes were expressed as crude odds ratios (ORs) and adjusted ORs for age, race, gender, surgeon volume, and hospital volume. Results. Higher Deyo scores tended to be associated with higher hospital mortality, length of hospital stay, postoperative complications, and hospital costs. Compared with the referent group (Deyo score=0), patients with the highest Deyo scores (5–36) exhibited adjusted ORs of 11.8 for hospital mortality (p=0.011) and 1.1 for developing postoperative complications (p=0.098), and had the highest length of hospital stay (mean, 4.1 days) and hospital costs (mean, US$18 549). Conclusion. The Deyo score was a predictor of outcomes and costs in the shoulder arthroplasty population. By identifying relevant factors, health care providers can better determine who should be referred for shoulder arthroplasty and what should be considered when assessing risks and benefits.

Adherence to oral anticancer treatments is critical in the disease trajectory of patients with breast cancer. Given the impact of nonadherence on clinical outcomes and the associated economic burden for the health care system, finding ways to increase treatment adherence is particularly relevant. The primary end point is to evaluate the effectiveness of a decision support system (DSS) and a machine learning web application in promoting adherence to oral anticancer treatments among patients with metastatic breast cancer. The secondary end point is to collect a set of new physical, psychological, social, behavioral, and quality of life predictive variables that could be used to refine the preliminary version of the machine learning model to predict patients' adherence behavior. This prospective, randomized controlled study is nested in a large-scale international project named \"Enhancing therapy adherence among metastatic breast cancer patients\" (Pfizer 65080791), aimed to develop a predictive model of nonadherence and associated DSS and guidelines to foster patients' engagement and therapy adherence. A web-based DSS named TREAT (treatment adherence support) was developed using a patient-driven approach, with 4 sections, that is, Section A: Metastatic Breast Cancer; Section B: Adherence to Cancer Therapies; Section C: Promoting Adherence; and Section D: My Adherence Diary. Moreover, a machine learning-based web application was developed to predict patients' risk factors of adherence to anticancer treatment, specifically pertaining to physical status and comorbid conditions, as well as short and long-term side effects. Overall, 100 patients consecutively admitted at the European Institute of Oncology (IEO) at the Division of Medical Senology will be enrolled; 50 patients with metastatic breast cancer will be exposed to the DSS and machine learning web application for 3 months (experimental group), and 50 patients will not be exposed to the intervention (control group). Each participant will fill a weekly medication diary and a set of standardized self-reports evaluating psychological and quality of life variables (Adherence Attitude Inventory, Beck Depression Inventory-II, Brief Pain Inventory, 13-item Sense of Coherence scale, Brief Italian version of Cancer Behavior Inventory, European Organization for Research and Treatment of Cancer Quality of Life 23-item Breast Cancer-specific Questionnaire, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, 8-item Morisky Medication Adherence Scale, State-Trait Anxiety Inventory forms I and II, Big Five Inventory, and visual analogue scales evaluating risk perception). The 3 assessment time points are T0 (baseline), T1 (1 month), T2 (2 months), and T3 (3 months). This study was approved by the IEO ethics committee (R1786/22-IEO 1907). The recruitment process started in May 2023 and is expected to conclude on December 2023. The contribution of machine learning techniques through risk-predictive models integrated into DSS will enable medication adherence by patients with cancer. ClinicalTrials.gov NCT06161181; https://clinicaltrials.gov/study/NCT06161181. DERR1-10.2196/48852.

BackgroundBone ingrowth into a cementless prosthesis can be achieved by both porous and hydroxyapatite coatings. The purpose of this study was to compare the performance of a hydroxyapatite-coated proximal sleeve and a porous bead-coated sleeve in patients managed with a modular revision hip system.MethodsBetween August 1992 and December 1996, fifty-three consecutive femoral revisions performed with an S-ROM stem in fifty-two patients were prospectively randomized at the time of surgery to either a hydroxyapatite-coated or a porous-coated sleeve. All patients were evaluated clinically and radiographically at three months, six months, and yearly for a minimum of two years (average, four years; range, two to 7.5 years). Femoral defects were classified according to the criteria of Paprosky et al. Six patients died and four patients were lost to follow-up, leaving forty-two patients (forty-three hips) as the final study group.ResultsFor the entire group, two femoral stems, one of which had been implanted in a hip with a Paprosky type-II femoral defect and the other in a hip with a Paprosky type-IIIB femoral defect, required a repeat revision, one for pain and the other for aseptic loosening. Radiographic evidence of bone ingrowth was observed in 96% (twenty-six) of the twenty-seven femora with type-I or II defects and in 81% (thirteen) of the sixteen femora with type-III defects. Femoral component survival, with use of revision as the end point, was 95% at four years for the entire group. The Harris hip scores were not significantly different when stratified by implant type, but were significantly different when stratified by bone loss (p < 0.05). In the femora with type-I or II defects, no difference was detected between those treated with a hydroxyapatite-coated implant and those that received a porous-coated implant with respect to bone ingrowth. However, in femora with type-III defects, the likelihood of the development of bone ingrowth was 2.6 (95% confidence interval, 1.3 to 5.17) times greater in hips that received a hydroxyapatite-coated implant (all eight developed ingrowth) than in hips that had a porous-coated implant (five of eight developed ingrowth) (p = 0.05).ConclusionsBone fixation was achieved more often with hydroxyapatite-coated sleeves in femora with Paprosky type-III defects, but no significant difference was noted in outcomes between the two implant types when used in bone with type-I or type-II femoral defects. Overall, the S-ROM modular hip stem performed better in femora with type-I or II bone defects than in femora with type-III defects.Level of EvidencePrognostic study, Level II-1 (retrospective study). See Instructions to Authors for a complete description of levels of evidence.

Background: Inguinal herniorrhaphy (IH) is a common outpatient procedure, yet postoperative pain and anesthetic side effects remain a problem. Paravertebral somatic nerve blocks (PVB) have the potential to offer unilateral abdominal wall anesthesia and long-lasting pain relief with minimal side effects. We compared PVB with peripheral neural blocks for outpatient IH. Methods: Forty-six patients scheduled for IH were entered into this prospective, single-blind study. All patients underwent a standardized general anesthetic. Patients were randomly assigned to receive a PVB (levels T10-L2) preoperatively (n = 24) or an intraoperative peripheral block (PB) by the surgeon (n = 22), using 0.5% ropivacaine (40 mL). Opioid use, verbal analog pain scores, and side effects were documented for 72 hours. Results: The use of opioids during surgery was less for the PVB group 162 ± 70 mg than the PB group, 210 ± 60 (P = .02). Need for opioids in PACU was less for the PVB group (39%) than the PB group (61%) (P = .002). Time until first pain after discharge was not different between groups, 312 ± 446 minutes (PB) and 425 ± 384 minutes (PVB) (P = .12). Of the PVB patients, 29% used no opioids at all compared with 18% of PB patients (P = .12). Mean time until first oxycodone use was similar between groups, 303 ± 469 minutes (PB) and 295 ± 225 minutes (PVB) (P = .18). Oxycodone use was also similar; 35 ± 34 mg (PVB) versus 49 ± 42 mg (PB) (P = .30). More patients in the PB group (50%) required antiemetic treatment in the postanesthesia care unit than the PVB group (21%) (P < .001). Side effects were similar at all other measurements. Conclusions: This study shows that PVB provides analgesia equivalent to extensive peripheral nerve block for inguinal herniorrhaphy, offering an alternative method of postoperative pain management and perhaps fewer side effects. Reg Anesth Pain Med 2002;27:476-480.

Background Roux-en-Y gastric bypass (RYGB) surgery is the gold standard surgical treatment for obesity. However, unintended nutritional deficiencies following this surgery are common, including changes in bone metabolism. We assessed changes in bone mineral density (BMD), nutritional compounds, and bone resorption markers before and 1 year following RYGB surgery. Methods Our study included 22 female patients with class II/III obesity. A clinical questionnaire, a 24-h recall, blood and urine samples, and dual-energy X-ray absorptiometry were provided. Results Mean age was 37.2 ± 9.6 years; 86 % were Caucasian and 77.2 % were premenopausal. Mean preoperative body mass index was 44.4 ± 5.0 and 27.5 ± 4.5 kg/m 2 at 1-year follow-up ( p  < 0.001). 25-OH-vitamin D-levels were similar in both periods [11.7 (9.7–18.0) vs. 15.7 (10.2–2.7) pg/dL, p  = 0.327]. Serum N -telopeptide (16.3 ± 3.4 vs. 38.2 ± 7.0 nM BCE, p  < 0.001) and parathyroid hormone (45.4 ± 16.7 vs. 62.7 ± 28.9 pg/mL, p  = 0.026) increased after RYGB surgery, reflecting bone resorption. BMD decreased after RYGB surgery in the lumbar spine (1.13 ± 0.11 vs. 1.04 ± 0.09 g/cm 2 , p  = 0.001), femoral neck (1.03 ± 0.15 vs. 0.94 ± 0.16 g/cm 2 , p  = 0.001), and total femur (1.07 ± 0.11 vs. 0.97 ± 0.15 g/cm 2 , p  = 0.003). Conclusions Decreased BMD in the lumbar spine, femoral neck, and total femur is detectable in women 1 year after RYGB surgery. Calcium malabsorption, caused by vitamin D deficiency and increased bone resorption, is partially responsible for these outcomes and should be targeted in future clinical trials.

BackgroundAs far as we know, no previous study has determined the relationship between volume and outcomes for shoulder arthroplasty. We hypothesized that surgeons and hospitals with higher caseloads of total shoulder arthroplasties and hemiarthroplasties have better outcomes as measured by decreased mortality rate, shorter length of stay in the hospital, reduced postoperative complications, and routine disposition of patients on discharge.MethodsData on patients undergoing shoulder arthroplasty were extracted from the Nationwide Inpatient Sample databases for the years 1988 through 2000. Logistic regression with generalized estimating equations and multiple linear regression models were used to estimate the adjusted association between surgeon and hospital volume and outcomes for total shoulder arthroplasty and hemiarthroplasty after adjusting for comorbidity, age, race, household income, and sex.ResultsThe mortality rates for patients who had a total shoulder arthroplasty performed by surgeons who did fewer than two procedures per year (0.36%) or who did between two and fewer than four procedures per year (0.32%) were higher than those for patients who had a total shoulder arthroplasty performed by surgeons who did four procedures or more per year (0.20%). The risk-adjusted rate of postoperative complications after hemiarthroplasty was significantly higher for patients managed by surgeons who performed fewer than two procedures per year (1.68%) than for those managed by surgeons with a volume of five procedures or more per year (0.97%). The possibility of postoperative complications when total shoulder arthroplasty was performed in hospitals with a volume of fewer than five procedures (1.44%) or in those with a volume of five to ten procedures per year (1.45%) was significantly higher than that in hospitals where ten procedures or more were performed every year (0.64%). The mean lengths of stay in the hospital after total shoulder arthroplasty and hemiarthroplasty were significantly longer when the operations were performed by surgeons who did fewer than two procedures per year or when they were done in hospitals with a volume of fewer than five procedures per year or with a volume of five to fewer than ten procedures per year than when they were done in hospitals or by surgeons in the highest volume category (p < 0.001).ConclusionsPatients who have a total shoulder arthroplasty or hemiarthroplasty performed by a high-volume surgeon or in a high-volume hospital are more likely to have a better outcome.Level of EvidenceTherapeutic study, Level III-2 (retrospective cohort study). See Instructions to Authors for a complete description of levels of evidence.

Summary BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is currently the main indication for lung transplant (LTx) in the United States. Opinions differ regarding the outcomes in IPF compared to other conditions. This study compares the short-term outcomes of LTx in IPF versus non-IPF as well as single lung transplant (SLT) versus bilateral lung transplant (BLT) in IPF patients in a large nationally representative sample. METHODS: We performed a secondary analysis of the Nationwide Inpatient Sample (1988–2006). Patients aged 21 and above who underwent LTx during this period were included. The five post-operative outcomes evaluated were inpatient mortality (IM), transplant-related complications (TC), non-transplant related (NTC) complications during inpatient stay, length of stay (LOS) more than 14 days and any non-routine discharge (ND) destination. RESULTS: There were 1845 patients who underwent LTx during the analysis period. Controlling for confounders, and compared to non-IPF patients, IPF patients were more likely to be in hospital more than 14 days (OR = 1.75; 95% CI = 1.31, 2.36; p ≤ 0.001); as likely to have inpatient mortality (OR = 1.00; 95% CI = 0.58, 1.72) and non-routine discharge (OR = 0.95; 95% CI = 0.73, 1.50); and not significantly less likely to have transplant-related complications (OR = 0.82; 95% CI = 0.57, 1.17) and non-transplant related complications (OR = 0.89; 95% CI = 0.65, 1.22). IPF patients who underwent BLT were significantly more likely to develop transplant-related complications (OR = 2.52; 95% CI = 1.06, 5.97; p = 0.035) and non-transplant related complications (OR = 2.22; 95% CI = 1.17, 4.24; p = 0.015); and not significantly more likely to have inpatient mortality (OR = 2.24; 95% CI = 0.80, 6.27), length of stay longer than 14 days (OR = 1.84; 95% CI = 0.83, 4.11) and non-routine discharge (OR = 1.15; 95% CI = 0.44, 1.69). CONCLUSIONS: This paper demonstrated that in this population of patients in the United States, there was an increased risk of greater LOS for IPF patients. BLT in IPF patients had a significantly higher risk for inpatient complications.