bluuebunny/crossref_metadata_2025_split huggingface dataset:
Prevalence and associated factors of incident and persistent loneliness among middle-aged and older adults in Thailand
Authors: Pengpid Supa , Peltzer Karl 
Published: March 2023

Abstract
Background
The aim of the study was to assess the prevalence and associated factors of incident and persistent loneliness in a prospective cohort study among middle-aged and older adults (≥ 45 years) in Thailand.

Methods
Longitudinal data from the Health, Aging, and Retirement in Thailand (HART) study in 2015 and 2017 were analysed. Loneliness was assessed with one item from the Center for Epidemiological Studies Depression scale. Logistic regression was used to calculate predictors of incident and persistent loneliness.

Results
In total, at baseline 21.7% had loneliness, 633 of 3696 participants without loneliness in 2015 had incident loneliness in 2017 (22.2%), and 239 of 790 adults had persistent loneliness (in both 2015 and 2017) (30.3%). In adjusted logistic regression analysis, low income (aOR: 1.27, 95% CI: 1.03 to 1.57), poor self-rated physical health status (aOR: 1.64, 95% CI: 1.27 to 2.12), hypertension (aOR: 1.34, 95% CI: 1.09 to 1.65), depressive symptoms (aOR: 1.97, 95% CI: 1.11 to 3.49), and having three or chronic conditions (aOR: 1.76, 95% CI: 1.19 to 2.60) were positively associated and a higher education (aOR: 0.74, 95% CI: 0.55 to 0.98) and living in the southern region of Thailand (aOR: 0.43, 95% CI: 0.30 to 0.61) were inversely associated with incident loneliness. Poor self-rated physical health status (aOR: 1.91, 95% CI: 1.26 to 2.88), and having three or more chronic diseases (aOR: 1.78, 95% CI: 1.07 to 2.98), were positively associated, and living in the southern region (aOR: 0.40, 95% CI: 0.25 to 0.65) was inversely associated with persistent loneliness.

Conclusion
More than one in five ageing adults had incident loneliness in 2 years of follow-up. The prevalence of incident and/or persistent loneliness was higher in people with a lower socioeconomic status, residing in the central region, poor self-rated physical health status, depressive symptoms, hypertension, and a higher number of chronic diseases.
Computer‐assisted analysis of functional internal rotation after reverse total shoulder arthroplasty: implications for component choice and orientation
Authors: Hochreiter Bettina , Meisterhans Michel , Zindel Christoph , Calek Anna‐Katharina , Gerber Christian 
Published: March 2023

AbstractPurposeFunctional internal rotation (IR) is a combination of extension and IR. It is clinically often limited after reverse total shoulder arthroplasty (RTSA) either due to loss of extension or IR in extension. It was the purpose of this study to determine the ideal in‐vitro combination of glenoid and humeral components to achieve impingement‐free functional IR.MethodsRTSA components were virtually implanted into a normal scapula (previously established with a statistical shape model) and into a corresponding humerus using a computer planning program (CASPA). Baseline glenoid configuration consisted of a 28 mm baseplate placed flush with the posteroinferior glenoid rim, a baseplate inclination angle of 96° (relative to the supraspinatus fossa) and a 36 mm standard glenosphere. Baseline humeral configuration consisted of a 12 mm humeral stem, a metaphysis with a neck shaft angle (NSA) of 155° (+ 6 mm medial offset), anatomic torsion of ‐20° and a symmetric PE inlay (36mmx0mm). Additional configurations with different humeral torsion (‐20°, + 10°), NSA (135°, 145°, 155°), baseplate position, diameter, lateralization and inclination were tested. Glenohumeral extension of 5, 10, 20, and 40° was performed first, followed by IR of 20, 40, and 60° with the arm in extension of 40°—the value previously identified as necessary for satisfactory clinical functional IR. The different component combinations were taken through simulated ROM and the impingement volume (mm3) was recorded. Furthermore, the occurrence of impingement was read out in 5° motion increments.ResultsIn all cases where impingement occurred, it occurred between the PE inlay and the posterior glenoid rim. Only in 11 of 36 combinations full functional IR was possible without impingement. Anterosuperior baseplate positioning showed the highest impingement volume with every combination of NSA and torsion. A posteroinferiorly positioned 26 mm baseplate resulting in an additional 2 mm of inferior overhang as well as 6 mm baseplate lateralization offered the best impingement‐free functional IR (5/6 combinations without impingement). Low impingement potential resulted from a combination of NSA 135° and + 10° torsion (4/6 combinations without impingement), followed by NSA 135° and ‐20° torsion (3/6 combinations without impingement) regardless of glenoid setup.ConclusionThe largest impingement‐free functional IRs resulted from combining a posteroinferior baseplate position, a greater inferior glenosphere overhang, 90° of baseplate inclination angle, 6 mm glenosphere lateralization with respect to baseline setup, a lower NSA and antetorsion of the humeral component. Surgeons can employ and combine these implant configurations to achieve and improve functional IR when planning and performing RTSA.Level of evidenceBasic Science Study, Biomechanics.
Prevalence of Sjögren's syndrome according to 2016 ACR-EULAR classification criteria in patients with systemic lupus erythematosus
Authors: Gianordoli Ana Paula Espíndula , Laguardia Rafaella Vila Real Barbosa , Santos Maria Carmen F. S. , Jorge Fabiano Cade , da Silva Salomão Amanda , Caser Larissa Carvalho , Moulaz Isac Ribeiro , Serrano Érica Vieira , Miyamoto Samira Tatiyama , Machado Ketty Lysie Libardi Lira , Valim Valéria 
Published: March 2023

Abstract
Background
Diagnosis of SS is a complex task, as no symptom or test is unique to this syndrome. The American-European Consensus Group (AECG 2002) and the American-European classification criteria of 2016 (ACR/EULAR 2016) emerged through a search for consensus. This study aims to assess the prevalence of Sjögren’s Syndrome (SS) in patients with Systemic Lupus Erythematosus (SLE), according to AECG 2002 and ACR-EULAR 2016 classifications, as well as clinical and histopathological features in this overlap. To date, there is no study that has evaluated SS in SLE, using the two current criteria.

Methods
This cross-sectional study evaluated 237 SLE patients at the outpatient rheumatology clinic between 2016 and 2018. Patients were submitted to a dryness questionnaire, whole unstimulated salivary flow (WUSF), “Ocular Staining Score” (OSS), Schirmer’s test I (ST-I), and labial salivary gland biopsy (LSGB).

Results
After verifying inclusion and exclusion criteria, a total of 117 patients were evaluated, with predominance of females (94%) and mixed ethnicity (49.6%). The prevalence of SS was 23% according to AECG 2002 and 35% to ACR-EULAR 2016. Kappa agreement between AECG 2002 and ACR-EULAR 2016 were 0.7 (p < 0.0001). After logistic regression, predictors for SS were: anti/Ro (OR = 17.86, p < 0.05), focal lymphocytic sialadenitis (OR = 3.69, p < 0.05), OSS ≥ 5 (OR = 7.50, p < 0.05), ST I positive (OR = 2.67, p < 0.05), and WUSF ≤ 0.1 mL/min (OR = 4.13, p < 0.05).

Conclusion
The prevalence of SS in SLE was 23% (AECG 2002) and 35% (ACR-EULAR 2016). The presence of glandular dysfunction, focal lymphocytic sialadenitis, and anti/Ro were predictors of SS in SLE. The greatest advantage of the new ACR-EULAR 2016 criteria is to enable an early diagnosis and identify the overlapping of these two diseases. ACR-EULAR 2016 criteria is not yet validated for secondary SS and this study is a pioneer in investigating prevalence based on the new criteria.
Patient (pt) perspective on fatigue and its management for advanced prostate cancer (PC) treated with androgen receptor inhibitors (ARIs).
Authors: Freedland Stephen J. , Chakoian Marty , Wells Edward , El-Chaar Nader N. , Colon Alexandra , Elsounda Dina , Hong Agnes 
Published: March 2023

100 Background: Fatigue is a common, multifaceted disease- and treatment (tx)-related symptom experienced by pts with advanced PC (aPC). Although fatigue of variable severity has been reported across clinical trials in pts with metastatic hormone-sensitive PC (also referred to as metastatic castration-sensitive PC [mCSPC]) and non-metastatic castration-resistant PC (nmCRPC) treated with ARIs, there is limited real-world insight from the pt’s perspective or guidance on the management of this symptom. This study assessed pts’ experience with fatigue and self-reported management strategies. Methods: In this cross-sectional non-interventional qualitative research study, pts receiving ARIs were interviewed about their fatigue experience and management strategies. All pts were ≥18 years, diagnosed with mCSPC or nmCRPC, currently on ARI tx (enzalutamide, apalutamide or darolutamide) that began ≤24 months (mo) prior to interview and experienced fatigue. Descriptive data extracted were organized into general concepts and presented as number and frequency of reports. Results: Among 143 screened pts, 11 completed the interview (mCSPC, 7; nmCRPC, 4). Most were White, mean age was 63 years and median time since ARI initiation was 12 mo. Pts described their fatigue experience as a physical, emotional or mental feeling that impacted activities of daily living. Pts attributed their fatigue to more than one cause including, but not limited to: a side effect of ARI tx, emotional burden of disease, or physical exertion. Most pts did not feel adequately prepared and indicated they would have liked to receive additional education or support to manage tx-related fatigue. As a result, most pts followed self-initiated management strategies such as healthy diet, rigorous exercise and increased rest, which were reported to be effective for some pts. Conclusions: Pts with aPC emphasized the lack of adequate knowledge and health care provider (HCP) recommendations for managing fatigue. Hence, there is a need to develop recommendations for fatigue management and resources to support HCPs’ counselling methods to ultimately improve pts’ quality of life while on tx. HCPs may play a critical role in developing and disseminating fatigue management initiatives. [Table: see text]
Efficacy and safety of docetaxel (D) vs androgen-receptor signaling inhibitors (ARSi) as second-line therapy (Rx) after progression on alternative ARSi as first-line Rx for patients who are elderly (≥75 years old) with metastatic castration-resistant prostate cancer (mCRPC) in a multicenter international database: A SPARTACUSS–Meet-URO 26 study.
Authors: Gennusa Vincenzo , Saieva Calogero , Lee-Ying Richard M. , Nuzzo Pier Vitale , Spinelli Gian Paolo , Zanardi Elisa , Fotia Giuseppe , Rossetti Sabrina , Valenca Loana Bueno , Patrikidou Anna , Andrade Livia , Pereira Mestre Ricardo , Fornarini Giuseppe , Procopio Giuseppe , Santini Daniele , Sweeney Christopher , Heng Daniel Yick Chin , De Giorgi Ugo , Russo Antonio , Francini Edoardo 
Published: March 2023

166 Background: About 2/3 of all prostate cancer (PCa) deaths occur in patients aged ≥75, who are frequently diagnosed with advanced PCa. ARSi abiraterone acetate (AA) and enzalutamide (E) are the most common 1st line Rx for patients with mCRPC. Yet, the optimal treatment sequence for the elderly ≥75 after ARSi failure is still unclear. Methods: Using available medical records, patients aged ≥75 who started ARSi as 1st line Rx for mCRPC within January 2015 - April 2019 and, upon progression, 2nd line alternative ARSi or D were identified from the IRB approved hospital registries of 10 centers in Europe, North and South America. Patients were categorized by type of 2nd line Rx for mCRPC into cohorts AA/E and D. Primary endpoints were overall survival (OS) from 1st line AA/E start, OS and radiographic progression-free survival (rPFS) from 2nd line Rx start, and safety. The Kaplan Meier method was used to calculate endpoint distributions and medians (95% CI). Results: Of the 122 patients identified, 57 (46.7%) had AA/E and 65 (53.3%) D, as 2nd line Rx for mCRPC. Median follow-up was 26.3 months (95% CI, 23.1-27.9 months). Cohort AA/E tended to be older (81 vs 78 years; p=0.001) and with high-volume disease (45.5% vs 25.0%; p=0.022) compared to cohort D. No significant difference in OS from 1st line ARSi onset and OS or rPFS from 2nd line Rx start was found between the 2 cohorts. Cohort AA/E had longer rPFS than cohort D, albeit not significant (18.5 vs 12.0 months; p=0.13). Rates of adverse events (AEs) of any grade (42.1 vs 53.8; p=0.21) and AEs of grade ≥3 (19.3% vs 18.5%; p=1.0) did not show significant differences between the 2 cohorts. Conclusions: Within the limitations of small cohorts and retrospective design, treatment sequences with 2nd line AA/E or D after failure of 1st line alternative ARSi for mCRPC showed similar efficacy and safety in the elderly ≥75 years old.
Outcomes of post-progression therapies in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) progressing after docetaxel (DOC): Real-world data from an Italian multicenter observational study (ECHOS trial).
Authors: Caffo Orazio , Maruzzo Marco , Samuelly Alessandro , Facchini Gaetano , Zanardi Elisa , Nicodemo Maurizio , Ermacora Paola , Sorarù Mariella , Galli Luca , Cattrini Carlo , Borsellino Nicolo , Buti Sebastiano , Rebuzzi Sara Elena , Iacovelli Roberto , Rametta Alessandro , Calvani Nicola , Giordano Monica , Farnesi Azzurra , Fratino Lucia , Basso Umberto 
Published: March 2023

171 Background: The introduction of DOC in mCSPC raises the issue concerning the best therapeutic strategy after pts’ progression. Different options are available: a switch strategy with an androgen receptor signaling inhibitor (ARSI), an alternative chemotherapy-based strategy based on cabazitaxel (CABA), or a re-challenge strategy by using DOC again. In this view, it could be of interest to describe the outcomes of post-progression strategies adopted in the real-world. From 2014, ECHOS multicenter study is collecting real world data from mCSPC pts in Italy. Here, we present post-progression preliminary findings of 568 pts treated with DOC and enrolled in the study within 31 December 2021. Methods: We reviewed the clinical records of the mCSPC pts treated with DOC in 34 Italian Institutions. For each pt we recorded pre- and post-DOC clinical history, baseline characteristics, treatment details and clinical outcomes. Results: Among the 568 pts, after a median follow-up of 22 mos, 389 pts experienced disease progression and 227 died. The progression occurred after a median of 10.4 mos (range 0.3-62.1). Among the progressed pts, 47 did not received further active treatment, while 342 received at least one systemic treatment after progression. The most frequent post-progression treatment was ARSI (73.1%), followed by CABA (19%), combination of ARSI and PARP inhibitors within clinical trials (2.6%), DOC re-challenge (2.1%), platinum-based chemotherapy (1.8%), and radium 223 (0.9%). The outcomes of the first-line agents and the number of subsequent administered life-prolonging agents (LPA) are described. The length of disease control obtained with DOC influenced the duration of first post-progression therapy: in pts who progressed after DOC within 10.4 mos, the duration was significantly shorter than in pts with later disease progression (5.9 mos vs 9.8 mos, p < 0.0001). Noteworthy, pts with more aggressive disease leading to a faster progression received more frequently CABA than ARSI: disease progression after DOC in CABA group and in ARSI group occurred with a median of 9.1 mos and 13.2 mos, respectively (p = 0.002). Conclusions: This is one of the largest real-world report on the outcomes of first post-progression therapies after DOC in mCSPC pts. We showed that ARSI-based therapy is the most common strategy adopted after DOC progression. Our findings suggested a different first post-progression strategy according to the time of post-DOC progression onset. [Table: see text]
Phase 1/2 study of EPI-7386 in combination with enzalutamide (enz) compared with enz alone in subjects with metastatic castration-resistant prostate cancer (mCRPC).
Authors: Laccetti Andrew Leonard , Chatta Gurkamal S. , Iannotti Nicholas , Kyriakopoulos Christos , Villaluna Karen , Le Moigne Ronan , Cesano Alessandra 
Published: March 2023

179 Background: EPI-7386 is a next generation aniten designed to inhibit androgen receptor (AR) activity by binding to the N-terminal domain (NTD) of the AR while effectively blocking transcription despite AR resistance mechanisms driven by the ligand-binding domain (LBD), including point mutations and splice variants. Preclinical models demonstrate the combination of EPI-7386 with enzalutamide (enz) results in a deeper blockade of the AR pathway (per RNAseq and ChIPseq data) and greater antitumor activity, prompting initiation of this trial. Methods: This Phase 1/2 multicenter, open-label clinical trial (NCT05075577) is enrolling mCRPC pts on androgen deprivation therapy and naïve to second-generation antiandrogens (one line of prior chemotherapy allowed). Phase 1 (P1) of the trial examines escalating doses of EPI-7386 in combination with a fixed dose of enz. The primary and secondary endpoints of P1 are to evaluate the safety and pharmacokinetics (PK) aspects of EPI-7386 and enz when administered in combination to establish the recommended Phase 2 combination doses (RP2CDs) and address any possible drug-drug interactions. Once the RP2CDs are established, Phase 2 of the trial will commence as a two -arm, 2:1 randomized trial evaluating the antitumor activity of EPI-7386 in combination with enz versus enz alone. Results: Seven pts have been enrolled in the first 2 cohorts: 3 in cohort 1 (600 mg QD EPI-7386 + 120 mg QD enz) and 4 in cohort 2 (800 mg QD EPI-7386 + 120 mg QD enz). No DLTs were observed, and the safety profile was consistent with second-generation antiandrogens (e.g., Grade 1 or 2 AEs of fatigue and hot flashes). PK results demonstrated enz exposure was minimally impacted by EPI-7386, while, as expected, EPI-7386 exposure was reduced 60-80% by enz (well-established CYP3A4 inducer). The observed EPI-7386 exposures remained in the clinically relevant range suggested by preclinical xenograft studies. 4/6 evaluable patients showed a PSA decrease >90% at/before week 12 regardless of the pt’s previous chemotherapy status and 5/6 evaluable patients achieved a PSA decrease of at least 85%; all 6 patients showed stable disease by imaging. Conclusions: With no safety concerns from cohorts 1 and 2, cohort 3 is enrolling at 600 mg BID EPI-7386 + 120 mg QD enz to assess if the exposure of EPI-7386 can be further increased in light of the augmented metabolism of the drug induced by enz. Clinical trial information: NCT05075577 .
Randomized phase II study of olaparib (Ola) maintenance following cabazitaxel-carboplatin induction chemotherapy (CabCarb) in men with aggressive variant prostate cancer (AVPC).
Authors: Pilié Patrick Glen , Slack Tidwell Rebecca , Viscuse Paul Vincent , Subudhi Sumit Kumar , Corn Paul Gettys , Tu Shi-Ming , Araujo John C. , Zurita Amado J. , Wang Jennifer , Efstathiou Eleni , Deinert Jessica , Logothetis Christopher , Thompson Timothy C. , Aparicio Ana 
Published: March 2023

196 Background: An aggressive subset of prostate cancers (AVPC) respond poorly to androgen signaling inhibitors, have limited therapeutic options and a dismal prognosis. Preclinical models of AVPC display functional alterations in DNA damage response (DDR) pathways linked to platinum and PARP inhibitor (PARPi) sensitivity. We hypothesized that PARPi (ola) maintenance following CabCarb would improve the progression free survival (PFS) of men with AVPC. We performed a tissue-rich randomized trial for men with AVPC to address this hypothesis and unravel the heterogeneity of AVPC by linking genomic and transcriptomic analyses with clinical outcomes. Methods: In a single-institution study, men with CRPC meeting ≥ 1 of 9 AVPC criteria and ECOG performance status (PS) of 0-2 received 6 cycles of Cab 20-25mg/m2 and Carbo (AUC 3-4). Men completing 6 cycles without progressive disease (PD) were randomized 2:1 to Ola 300mg BID vs. observation (Obs). The primary endpoint is to estimate PFS in those randomized and we aimed to detect a difference of 3.9 vs. 7.8 months. Subgroup comparisons between patients who had PD prior to randomization (platinum-resistant) vs. those randomized (platinum sensitive) were made with chi-square tests for categorical baseline characteristics, and Kruskal-Wallis test for continuous measures. Results: 96 patients started CabCarb. Their median age was 67 years (43-86), most were white/non-Hispanic (74%), had an ECOG score of 0 (64%), bone metastases (79%), and no prior docetaxel therapy (59%). Of the 96, 7 (7.3%) went off study for reasons unrelated to PD and 36 (37.5%) had PD prior to randomization. Patients with PD prior to randomization were more likely at baseline to have received prior docetaxel (59% vs. 29%; p=0.004), have bone metastases (92% vs. 71%; p=0.03), have lower hemoglobin (11.4 vs. 12. 4; p=0.02), higher LDH (359 vs. 260; p=0.01), lower albumin (4.0 vs. 4.2; p=0.04), and higher AlkPhos (181.5 vs. 98.5; p=0.01) compared to patients who went on to randomization. With a median follow up time of 38.9 months post randomization, the median PFS was 2.3 months (95% confidence interval: 1.3, 4.6 months) for Observation and 4.9 (3.5, 6.3) months with Olaparib (p=0.12). The median OS was 16.2 (6.8, 26.4) for observation and 15.3 (10.2, 28.4) months with Olaparib (p=0.56). Conclusions: These data highlight the heterogeneity within the AVPC subset. Ongoing molecular analyses of sequential liquid and tumor tissue will illuminate the underpinnings of this heterogeneity and identify targets for additional combinatorial strategies. Clinical trial information: NCT03263650 .