Superabsorbent Wound Dressing for Management of Patients With Moderate-to-Highly Exuding Chronic Leg Ulcers: An Early Stage Model-Based Benefit–Harm Assessment

Author(s):  
Vladica M. Velickovic ◽  
Jean P. Lembelembe ◽  
Francisco Cegri ◽  
Ivana Binic ◽  
Amr B. Abdelaziz ◽  
...  

The aim of the research is to assess the benefit–harm of superabsorbent polymers wound dressings based on polyacrylate polymers (SAPs) compared with standard of care (SoC) dressing mix for patients with moderate-to-highly exuding hard-to-heal leg ulcers. The SoC dressings mix was composed of other superabsorbents in 29% of cases, antimicrobials 26%, foams 20%, alginates 5%, and other dressings 19% weighted according to their frequency. We have used the decision-analytic modeling method, Markov process, as an adequate analytical solution for medical prognosis. We have combined the systematic literature search to identify the most relevant inputs for the analysis, with available patient-level clinical data concerning benefits of superabsorbent to generate a robust prediction of patient-relevant outcomes, including healing rates and health-related quality of life. Besides, we have qualitatively described adverse events associated with those treatments. Our research indicates that SAPs when compared with SoC dressing mix in a patient with moderate-to-highly excluding leg ulcers are leading to an improved healing rate with an absolute risk difference of 2.20% in 6 months and a relative risk of 1.07 in favor of SAP dressings. The attributable fraction among those exposed to SAP dressings of 6.6%, meaning that 6.6% of the healed ulcers could be attributed to having had the SAP dressing treatment instead of the SoC dressing treatment. Besides, SAP dressings lead to improved quality of life measured as incremental quality-adjusted life weeks (QALWs) of 0.13 QALWs.

Author(s):  
Daphne H. M. Jacobs ◽  
Ramona K. Charaghvandi ◽  
Nanda Horeweg ◽  
John H. Maduro ◽  
Gabrielle Speijer ◽  
...  

Abstract Purpose To evaluate and compare health-related quality of life (HRQL) of women with early-stage breast cancer (BC) treated with different radiotherapy (RT) regimens. Methods Data were collected from five prospective cohorts of BC patients treated with breast-conserving surgery and different RT regimens: intraoperative RT (IORT, 1 × 23.3 Gy; n = 267), external beam accelerated partial breast irradiation (EB-APBI, 10 × 3.85 Gy; n = 206), hypofractionated whole breast irradiation(hypo-WBI, 16 × 2.67 Gy; n = 375), hypo-WBI + boost(hypo-WBI-B, 21–26 × 2.67 Gy; n = 189), and simultaneous WBI + boost(WBI-B, 28 × 2.3 Gy; n = 475). Women ≥ 60 years with invasive/in situ carcinoma ≤ 30 mm, cN0 and pN0-1a were included. Validated EORTC QLQ-C30/BR23 questionnaires were used to asses HRQL. Multivariable linear regression models adjusted for confounding (age, comorbidity, pT, locoregional treatment, systemic therapy) were used to compare the impact of the RT regimens on HRQL at 12 and 24 months. Differences in HRQL over time (3–24 months) were evaluated using linear mixed models. Results There were no significant differences in HRQL at 12 months between groups except for breast symptoms which were better after IORT and EB-APBI compared to hypo-WBI at 12 months (p < 0.001). Over time, breast symptoms, fatigue, global health status and role functioning were significantly better after IORT and EB-APBI than hypo-WBI. At 24 months, HRQL was comparable in all groups. Conclusion In women with early-stage breast cancer, the radiotherapy regimen did not substantially influence long-term HRQL with the exception of breast symptoms. Breast symptoms are more common after WBI than after IORT or EB-APBI and improve slowly until no significant difference remains at 2 years posttreatment.


2017 ◽  
Vol 13 (5) ◽  
pp. e463-e473 ◽  
Author(s):  
Laura C. Pinheiro ◽  
Stephanie B. Wheeler ◽  
Katherine E. Reeder-Hayes ◽  
Cleo A. Samuel ◽  
Andrew F. Olshan ◽  
...  

Purpose: Endocrine therapy (ET) underuse puts women at increased risk for breast cancer (BC) recurrence. Our objective was to determine if health-related quality of life (HRQOL) subgroups were associated with underuse. Methods: Data came from the third phase of the Carolina Breast Cancer Study. We included 1,599 women with hormone receptor–positive BC age 20 to 74 years. HRQOL was measured, on average, 5 months postdiagnosis. Subgroups were derived using latent profile (LP) analysis. Underuse was defined as not initiating or adhering to ET by 36 months postdiagnosis. Multivariable logistic regression models estimated adjusted odds ratios (ORs) between HRQOL LPs and underuse. The best HRQOL LP was the reference. Chemotherapy- and race-stratified models were estimated, separately. Results: Initiation analyses included 953 women who had not begun ET by their 5-month survey. Of these, 154 never initiated ET. Adherence analyses included 1,114 ET initiators, of whom 211 were nonadherent. HRQOL was not significantly associated with noninitiation, except among nonchemotherapy users, with membership in the poorest LP associated with increased odds of noninitiation (adjusted OR, 5.5; 95% CI, 1.7 to 17.4). Membership in the poorest LPs was associated with nonadherence (LP1: adjusted OR, 2.2; 95% CI, 1.2 to 4.0 and LP2: adjusted OR,1.9; 95% CI, 1.1 to 3.6). Membership in the poorest LP was associated with nonadherence among nonchemotherapy users (adjusted OR, 2.1; 95% CI, 1.2 to 5.1). Conclusion: Our results suggest women with poor HRQOL during active treatment may be at increased risk for ET underuse. Focusing on HRQOL, a modifiable factor, may improve targeting of future interventions early in the BC continuum to improve ET initiation and adherence and prevent BC recurrence.


Pancreas ◽  
2020 ◽  
Vol 49 (3) ◽  
pp. 393-407 ◽  
Author(s):  
Teresa Macarulla ◽  
Andrew E. Hendifar ◽  
Chung-Pin Li ◽  
Michele Reni ◽  
Hanno Riess ◽  
...  

Author(s):  
Kevin J Harrington ◽  
Denis Soulières ◽  
Christophe Le Tourneau ◽  
Jose Dinis ◽  
Lisa F Licitra ◽  
...  

Abstract Background Head and neck squamous cell carcinoma (HNSCC) affects health-related quality of life (HRQoL); few treatments have demonstrated clinically meaningful HRQoL benefit. KEYNOTE-040 evaluated pembrolizumab vs standard of care (SOC) in patients with recurrent and/or metastatic HNSCC whose disease recurred or progressed after platinum-containing regimen. Methods Patients received pembrolizumab 200 mg or SOC (methotrexate, docetaxel, or cetuximab). Exploratory HRQoL analyses used European Organisation for Research and Treatment of Cancer (EORTC) 30 quality-of-life, EORTC 35-question quality-of-life head and neck cancer-specific module, and EuroQoL 5-dimensions questionnaires. Results The HRQoL population comprised 469 patients (pembrolizumab = 241, SOC = 228). HRQoL compliance for patients in the study at week 15 was 75.3% (116 of 154) for pembrolizumab and 74.6% (85 of 114) for SOC. The median time to deterioration in global health status (GHS) and QoL scores were 4.8 months with pembrolizumab and 2.8 months with SOC (hazard ratio = 0.79, 95% confidence interval [CI] = 0.59 to 1.05). At week 15, GHS / QoL scores were stable for pembrolizumab (least squares mean [LSM] = 0.39, 95% CI = –3.00 to 3.78) but worsened for SOC (LSM = −5.86, 95% CI = −9.68 to −2.04); the LSM between-group difference was 6.25 points (95% CI = 1.32 to 11.18; nominal 2-sided P = .01). A greater difference in the LSM for GHS / QoL score occurred with pembrolizumab vs docetaxel (10.23, 95% CI = 3.15 to 17.30) compared with pembrolizumab vs methotrexate (6.21, 95% CI = −4.57 to 16.99) or pembrolizumab vs cetuximab (−1.44, 95% CI = −11.43 to 8.56). Pembrolizumab-treated patients had stable functioning and symptoms at week 15, with no notable differences from SOC. Conclusions GHS / QoL scores were stable with pembrolizumab but declined with SOC in patients at week 15, supporting the clinically meaningful benefit of pembrolizumab in recurrent and/or metastatic HNSCC.


Author(s):  
Linda S Taichman ◽  
William G Giannobile ◽  
Thomas M Braun ◽  
Marita R Inglehart ◽  
Catherine H Van Poznak

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