1.Outcomes of lateralized reverse total shoulder arthroplasty versus latissimus dorsi transfer for external rotation deficit: a systematic review and meta-analysis
Keegan M. HONES ; Caroline T. GUTOWSKI ; Taylor R. RAKAUSKAS ; Victoria E. BINDI ; Trevor SIMCOX ; Jonathan O. WRIGHT ; Bradley S. SCHOCH ; Thomas W. WRIGHT ; Jean-David WERTHEL ; Joseph J. KING ; Kevin A. HAO
Clinics in Shoulder and Elbow 2024;27(4):464-478
Background:
To compare clinical outcomes following lateralized reverse shoulder arthroplasty (RSA) versus RSA with latissimus dorsi transfer (LDT) in patients with poor preoperative active external rotation (ER).
Methods:
We performed a systematic review per Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We queried PubMed/Medline, Embase, Web of Science, and Cochrane databases to identify articles reporting clinical outcomes of RSA with LDT or lateralized RSA alone performed in patients with preoperative ER ≤0°. Our primary outcomes were active ER, active forward elevation (FE), Constant score, and the incidence of complications.
Results:
We included 12 RSA with LDT studies with 188 shoulders and 4 lateralized RSA without transfer studies with 250 shoulders. Mean preoperative ER in RSA with LDT was –14°, while mean preoperative ER in lateralized RSA alone was –11°. Lateralized RSA alone was associated with superior postoperative ER (28° vs. 22°, P=0.010) and Constant score (69 vs. 65, P=0.014), but similar postoperative FE (P=0.590). Pre- to postoperative improvement in ER and FE was similar between cohorts. RSA with LDT had a higher incidence of nerve-related complications (2.1% vs. 0%) and dislocation (2.8% vs. 0.8%) compared to lateralized RSA alone.
Conclusions
Both RSA with LDT and lateralized RSA are reliable options to restore ER in patients with significantly limited preoperative ER. Our analysis suggests that lateralized RSA alone is superior to RSA with LDT in patients with either a medialized or lateralized implant design and confers a lower risk of complications, particularly nerve injury and dislocation. However, the addition of an LDT may still be indicated in certain patient populations with very severe ER loss.Level of evidence: IV.
2.Clinical Trial Protocol for ROSELLA:a phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in advanced platinum-resistant ovarian cancer
Alexander B. OLAWAIYE ; Jae-Weon KIM ; Andrea BAGAMERI ; Erin BISHOP ; Anita CHUDECKA-GŁAZ ; Alix DEVAUX ; Laurence GLADIEFF ; Mary E. GORDINIER ; Jacob KORACH ; Michael E. MCCOLLUM ; Linda MILESHKIN ; Bradley J. MONK ; Shibani NICUM ; Angélica NOGUEIRA-RODRIGUES ; Ana OAKNIN ; David M. O’MALLEY ; Mauro ORLANDO ; Lyndah DREILING ; Iulia C. TUDOR ; Domenica LORUSSO
Journal of Gynecologic Oncology 2024;35(4):e111-
Background:
Ovarian cancer has the highest mortality among gynecologic cancers, primarily because it typically is diagnosed at a late stage and because of the development of chemoresistance in recurrent disease. Improving outcomes in women with platinumresistant ovarian cancer is a substantial unmet need. Activation of the glucocorticoidreceptor (GR) by cortisol has been shown to suppress the apoptotic pathways used by cytotoxic agents, limiting their efficacy. Selective GR modulation may be able to counteract cortisol’s antiapoptotic effects, enhancing chemotherapy’s efficacy. A previous phase 2 study has shown that adding intermittently dosed relacorilant, a selective GR modulator, to nab-paclitaxel improved outcomes, including progression-free survival (PFS) and overall survival (OS), with minimal added toxicity, in women with recurrent platinum-resistant ovarian cancer. The ROSELLA study aims to confirm and expand on these findings in a larger population.
Methods
ROSELLA is a phase 3, randomized, 2-arm, open-label, global multicenter study in women with recurrent, platinum-resistant, high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. Eligible participants have received 1 to 3 lines of prior systemic anticancer therapy, including ≥1 prior line of platinum therapy and prior treatment with bevacizumab, with documented progressive disease or intolerance to the most recent therapy. There is no biomarker-based requirement for participant selection. Participants are randomized 1:1 to receive intermittently dosed relacorilant in combination with nabpaclitaxel or nab-paclitaxel monotherapy. The study’s primary efficacy endpoint is PFS as assessed by blinded independent central review. Secondary efficacy endpoints include OS, investigator-assessed PFS, objective response rate, best overall response, duration of response, clinical benefit rate at 24 weeks, and cancer antigen 125 response. The study is also evaluating safety and patient-reported outcomes.Trial Registration: ClinicalTrials.gov Identifier: NCT05257408; European Union Drug Regulating Authorities Clinical Trials Database Identifier: 2022-000662-18
3.Outcomes of lateralized reverse total shoulder arthroplasty versus latissimus dorsi transfer for external rotation deficit: a systematic review and meta-analysis
Keegan M. HONES ; Caroline T. GUTOWSKI ; Taylor R. RAKAUSKAS ; Victoria E. BINDI ; Trevor SIMCOX ; Jonathan O. WRIGHT ; Bradley S. SCHOCH ; Thomas W. WRIGHT ; Jean-David WERTHEL ; Joseph J. KING ; Kevin A. HAO
Clinics in Shoulder and Elbow 2024;27(4):464-478
Background:
To compare clinical outcomes following lateralized reverse shoulder arthroplasty (RSA) versus RSA with latissimus dorsi transfer (LDT) in patients with poor preoperative active external rotation (ER).
Methods:
We performed a systematic review per Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We queried PubMed/Medline, Embase, Web of Science, and Cochrane databases to identify articles reporting clinical outcomes of RSA with LDT or lateralized RSA alone performed in patients with preoperative ER ≤0°. Our primary outcomes were active ER, active forward elevation (FE), Constant score, and the incidence of complications.
Results:
We included 12 RSA with LDT studies with 188 shoulders and 4 lateralized RSA without transfer studies with 250 shoulders. Mean preoperative ER in RSA with LDT was –14°, while mean preoperative ER in lateralized RSA alone was –11°. Lateralized RSA alone was associated with superior postoperative ER (28° vs. 22°, P=0.010) and Constant score (69 vs. 65, P=0.014), but similar postoperative FE (P=0.590). Pre- to postoperative improvement in ER and FE was similar between cohorts. RSA with LDT had a higher incidence of nerve-related complications (2.1% vs. 0%) and dislocation (2.8% vs. 0.8%) compared to lateralized RSA alone.
Conclusions
Both RSA with LDT and lateralized RSA are reliable options to restore ER in patients with significantly limited preoperative ER. Our analysis suggests that lateralized RSA alone is superior to RSA with LDT in patients with either a medialized or lateralized implant design and confers a lower risk of complications, particularly nerve injury and dislocation. However, the addition of an LDT may still be indicated in certain patient populations with very severe ER loss.Level of evidence: IV.
4.Outcomes of lateralized reverse total shoulder arthroplasty versus latissimus dorsi transfer for external rotation deficit: a systematic review and meta-analysis
Keegan M. HONES ; Caroline T. GUTOWSKI ; Taylor R. RAKAUSKAS ; Victoria E. BINDI ; Trevor SIMCOX ; Jonathan O. WRIGHT ; Bradley S. SCHOCH ; Thomas W. WRIGHT ; Jean-David WERTHEL ; Joseph J. KING ; Kevin A. HAO
Clinics in Shoulder and Elbow 2024;27(4):464-478
Background:
To compare clinical outcomes following lateralized reverse shoulder arthroplasty (RSA) versus RSA with latissimus dorsi transfer (LDT) in patients with poor preoperative active external rotation (ER).
Methods:
We performed a systematic review per Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We queried PubMed/Medline, Embase, Web of Science, and Cochrane databases to identify articles reporting clinical outcomes of RSA with LDT or lateralized RSA alone performed in patients with preoperative ER ≤0°. Our primary outcomes were active ER, active forward elevation (FE), Constant score, and the incidence of complications.
Results:
We included 12 RSA with LDT studies with 188 shoulders and 4 lateralized RSA without transfer studies with 250 shoulders. Mean preoperative ER in RSA with LDT was –14°, while mean preoperative ER in lateralized RSA alone was –11°. Lateralized RSA alone was associated with superior postoperative ER (28° vs. 22°, P=0.010) and Constant score (69 vs. 65, P=0.014), but similar postoperative FE (P=0.590). Pre- to postoperative improvement in ER and FE was similar between cohorts. RSA with LDT had a higher incidence of nerve-related complications (2.1% vs. 0%) and dislocation (2.8% vs. 0.8%) compared to lateralized RSA alone.
Conclusions
Both RSA with LDT and lateralized RSA are reliable options to restore ER in patients with significantly limited preoperative ER. Our analysis suggests that lateralized RSA alone is superior to RSA with LDT in patients with either a medialized or lateralized implant design and confers a lower risk of complications, particularly nerve injury and dislocation. However, the addition of an LDT may still be indicated in certain patient populations with very severe ER loss.Level of evidence: IV.
5.Clinical Trial Protocol for ROSELLA:a phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in advanced platinum-resistant ovarian cancer
Alexander B. OLAWAIYE ; Jae-Weon KIM ; Andrea BAGAMERI ; Erin BISHOP ; Anita CHUDECKA-GŁAZ ; Alix DEVAUX ; Laurence GLADIEFF ; Mary E. GORDINIER ; Jacob KORACH ; Michael E. MCCOLLUM ; Linda MILESHKIN ; Bradley J. MONK ; Shibani NICUM ; Angélica NOGUEIRA-RODRIGUES ; Ana OAKNIN ; David M. O’MALLEY ; Mauro ORLANDO ; Lyndah DREILING ; Iulia C. TUDOR ; Domenica LORUSSO
Journal of Gynecologic Oncology 2024;35(4):e111-
Background:
Ovarian cancer has the highest mortality among gynecologic cancers, primarily because it typically is diagnosed at a late stage and because of the development of chemoresistance in recurrent disease. Improving outcomes in women with platinumresistant ovarian cancer is a substantial unmet need. Activation of the glucocorticoidreceptor (GR) by cortisol has been shown to suppress the apoptotic pathways used by cytotoxic agents, limiting their efficacy. Selective GR modulation may be able to counteract cortisol’s antiapoptotic effects, enhancing chemotherapy’s efficacy. A previous phase 2 study has shown that adding intermittently dosed relacorilant, a selective GR modulator, to nab-paclitaxel improved outcomes, including progression-free survival (PFS) and overall survival (OS), with minimal added toxicity, in women with recurrent platinum-resistant ovarian cancer. The ROSELLA study aims to confirm and expand on these findings in a larger population.
Methods
ROSELLA is a phase 3, randomized, 2-arm, open-label, global multicenter study in women with recurrent, platinum-resistant, high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. Eligible participants have received 1 to 3 lines of prior systemic anticancer therapy, including ≥1 prior line of platinum therapy and prior treatment with bevacizumab, with documented progressive disease or intolerance to the most recent therapy. There is no biomarker-based requirement for participant selection. Participants are randomized 1:1 to receive intermittently dosed relacorilant in combination with nabpaclitaxel or nab-paclitaxel monotherapy. The study’s primary efficacy endpoint is PFS as assessed by blinded independent central review. Secondary efficacy endpoints include OS, investigator-assessed PFS, objective response rate, best overall response, duration of response, clinical benefit rate at 24 weeks, and cancer antigen 125 response. The study is also evaluating safety and patient-reported outcomes.Trial Registration: ClinicalTrials.gov Identifier: NCT05257408; European Union Drug Regulating Authorities Clinical Trials Database Identifier: 2022-000662-18
6.Outcomes of lateralized reverse total shoulder arthroplasty versus latissimus dorsi transfer for external rotation deficit: a systematic review and meta-analysis
Keegan M. HONES ; Caroline T. GUTOWSKI ; Taylor R. RAKAUSKAS ; Victoria E. BINDI ; Trevor SIMCOX ; Jonathan O. WRIGHT ; Bradley S. SCHOCH ; Thomas W. WRIGHT ; Jean-David WERTHEL ; Joseph J. KING ; Kevin A. HAO
Clinics in Shoulder and Elbow 2024;27(4):464-478
Background:
To compare clinical outcomes following lateralized reverse shoulder arthroplasty (RSA) versus RSA with latissimus dorsi transfer (LDT) in patients with poor preoperative active external rotation (ER).
Methods:
We performed a systematic review per Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We queried PubMed/Medline, Embase, Web of Science, and Cochrane databases to identify articles reporting clinical outcomes of RSA with LDT or lateralized RSA alone performed in patients with preoperative ER ≤0°. Our primary outcomes were active ER, active forward elevation (FE), Constant score, and the incidence of complications.
Results:
We included 12 RSA with LDT studies with 188 shoulders and 4 lateralized RSA without transfer studies with 250 shoulders. Mean preoperative ER in RSA with LDT was –14°, while mean preoperative ER in lateralized RSA alone was –11°. Lateralized RSA alone was associated with superior postoperative ER (28° vs. 22°, P=0.010) and Constant score (69 vs. 65, P=0.014), but similar postoperative FE (P=0.590). Pre- to postoperative improvement in ER and FE was similar between cohorts. RSA with LDT had a higher incidence of nerve-related complications (2.1% vs. 0%) and dislocation (2.8% vs. 0.8%) compared to lateralized RSA alone.
Conclusions
Both RSA with LDT and lateralized RSA are reliable options to restore ER in patients with significantly limited preoperative ER. Our analysis suggests that lateralized RSA alone is superior to RSA with LDT in patients with either a medialized or lateralized implant design and confers a lower risk of complications, particularly nerve injury and dislocation. However, the addition of an LDT may still be indicated in certain patient populations with very severe ER loss.Level of evidence: IV.
7.Clinical Trial Protocol for ROSELLA:a phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in advanced platinum-resistant ovarian cancer
Alexander B. OLAWAIYE ; Jae-Weon KIM ; Andrea BAGAMERI ; Erin BISHOP ; Anita CHUDECKA-GŁAZ ; Alix DEVAUX ; Laurence GLADIEFF ; Mary E. GORDINIER ; Jacob KORACH ; Michael E. MCCOLLUM ; Linda MILESHKIN ; Bradley J. MONK ; Shibani NICUM ; Angélica NOGUEIRA-RODRIGUES ; Ana OAKNIN ; David M. O’MALLEY ; Mauro ORLANDO ; Lyndah DREILING ; Iulia C. TUDOR ; Domenica LORUSSO
Journal of Gynecologic Oncology 2024;35(4):e111-
Background:
Ovarian cancer has the highest mortality among gynecologic cancers, primarily because it typically is diagnosed at a late stage and because of the development of chemoresistance in recurrent disease. Improving outcomes in women with platinumresistant ovarian cancer is a substantial unmet need. Activation of the glucocorticoidreceptor (GR) by cortisol has been shown to suppress the apoptotic pathways used by cytotoxic agents, limiting their efficacy. Selective GR modulation may be able to counteract cortisol’s antiapoptotic effects, enhancing chemotherapy’s efficacy. A previous phase 2 study has shown that adding intermittently dosed relacorilant, a selective GR modulator, to nab-paclitaxel improved outcomes, including progression-free survival (PFS) and overall survival (OS), with minimal added toxicity, in women with recurrent platinum-resistant ovarian cancer. The ROSELLA study aims to confirm and expand on these findings in a larger population.
Methods
ROSELLA is a phase 3, randomized, 2-arm, open-label, global multicenter study in women with recurrent, platinum-resistant, high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. Eligible participants have received 1 to 3 lines of prior systemic anticancer therapy, including ≥1 prior line of platinum therapy and prior treatment with bevacizumab, with documented progressive disease or intolerance to the most recent therapy. There is no biomarker-based requirement for participant selection. Participants are randomized 1:1 to receive intermittently dosed relacorilant in combination with nabpaclitaxel or nab-paclitaxel monotherapy. The study’s primary efficacy endpoint is PFS as assessed by blinded independent central review. Secondary efficacy endpoints include OS, investigator-assessed PFS, objective response rate, best overall response, duration of response, clinical benefit rate at 24 weeks, and cancer antigen 125 response. The study is also evaluating safety and patient-reported outcomes.Trial Registration: ClinicalTrials.gov Identifier: NCT05257408; European Union Drug Regulating Authorities Clinical Trials Database Identifier: 2022-000662-18
8.Influence of lateralized versus medialized reverse shoulder arthroplasty design on external and internal rotation: a systematic review and meta-analysis
Kevin A. HAO ; Robert J. CUETO ; Christel GHARBY ; David FREEMAN ; Joseph J. KING ; Thomas W. WRIGHT ; Diana ALMADER-DOUGLAS ; Bradley S. SCHOCH ; Jean-David WERTHEL
Clinics in Shoulder and Elbow 2024;27(1):59-71
Restoration of external (ER) and internal rotation (IR) after Grammont-style reverse shoulder arthroplasty (RSA) is often unreliable. The purpose of this systematic review was to evaluate the influence of RSA medio-lateral offset and subscapularis repair on axial rotation after RSA. Methods: We conducted a systematic review of studies evaluating axial rotation (ER, IR, or both) after RSA with a defined implant design. Medio-lateral implant classification was adopted from Werthel et al. Meta-analysis was conducted using a random-effects model. Results: Thirty-two studies reporting 2,233 RSAs were included (mean patient age, 72.5 years; follow-up, 43 months; 64% female). The subscapularis was repaired in 91% (n=2,032) of shoulders and did not differ based on global implant lateralization (91% for both, P=0.602). On meta-analysis, globally lateralized implants achieved greater postoperative ER (40° [36°–44°] vs. 27° [22°–32°], P<0.001) and postoperative improvement in ER (20° [15°–26°] vs. 10° [5°–15°], P<0.001). Lateralized implants with subscapularis repair or medialized implants without subscapularis repair had significantly greater postoperative ER and postoperative improvement in ER compared to globally medialized implants with subscapularis repair (P<0.001 for both). Mean postoperative IR was reported in 56% (n=18) of studies and achieved the minimum necessary IR in 51% of lateralized (n=325, 5 cohorts) versus 36% (n=177, 5 cohorts) of medialized implants. Conclusions: Lateralized RSA produces superior axial rotation compared to medialized RSA. Lateralized RSA with subscapularis repair and medialized RSA without subscapularis repair provide greater axial rotation compared to medialized RSA with subscapularis repair. Level of evidence: 2A.
9.Stress Levels and Associated Factors Among Nursing Students From Different Ethnic Groups in Malaysia
K. Mangaikresh Krishnan ; Ming Tsuey Chew ; David Andrew Bradley ; Lean Keng Soon
Malaysian Journal of Medicine and Health Sciences 2022;18(No.3):133-139
Introduction: Nursing education and training is known to be an inherently stressful experience and poses challenging demands for students. The aim of this study is to evaluate the stress levels among nursing students from different ethnic groups in Malaysia. Methods: This cross-sectional study recruited the January to February 2020 nursing students from a private university in Malaysia with a self-administered questionnaire. Participants’ level of stress was measured using the Perceived Stress Scale (PSS) developed by Sheu and colleague in 2002. Data collected were analyzed with, One-way ANOVA and Spearman analysis to determine the significant factors associated with stress. Results: Two hundred nursing students across years one to three enrolled. The mean monthly household (family) income was MYR4686.25 ± 4660.38. Stress was significantly associated with ethnicity and monthly household (family) income (p< 0.05). Bonferroni post-hoc test demonstrated that the mean stress level of Malay students is statistically significant compared to Chinese and Indian students (p< 0.001). The PSS determined the nursing students’ stress level to be moderate. Conclusion: The association of stress levels with ethnicity, and monthly household (family) income suggested the need for suitable cultural and sufficient financial support for nursing students to reduce their stress levels.
10.Qualitative analysis of operational deliverables of the PGH-Child Protection Unit and Child Protection Network in advancing the care continuum for child maltreatment: A roadmap for setup and evaluation
Victoria L. M. Herrera ; David G. Bradley ; Bernadette J. Madrid
Acta Medica Philippina 2022;56(15):9-18
Objective:
Our goal is to identify an operational roadmap of core elements in the set-up of the Philippines General Hospital Child Protection Unit (PGH-CPU) established in 1997, and Child Protection Network (CPN) established in 2002. This roadmap will guide future improvement needs for PGH-CPU and CPN and could help accelerate the set-up of future child protection units or networks.
Methods:
Using the 5 pillars of the Care Continuum for Child Maltreatment for categorization of deliverables — multidisciplinary intervention, training, governance, research/publication, and prevention — we identified operational deliverables (excluding patient numbers and outcomes) of the PGH-CPU and CPN. These were qualitatively analyzed to identify trends across the past 20-years and along 5 pillars of the Care Continuum.
Results:
Identification and qualitative analyses of documented deliverables reveal pillar-specific and time-dependent trends across 5-year periods. This trend analysis identified the core elements central to the set-up of a CPU and reveal an operational roadmap in the set-up of CPUs in resource-constrained settings.
Conclusions
Case study review and qualitative analyses identify core elements that comprise a roadmap for need based prioritization in the set-up of CPUs/CPNs towards a comprehensive care continuum for child maltreatment. The 20-year experience in a developing nation context validates the roadmap
Continuity of Patient Care


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