Outcomes of metastatic synovial sarcoma with doxorubicin, pazopanib, and ifosfamide therapy.

e23552 Background: Synovial sarcoma (SS) accounts for 5-10% of all soft tissue sarcoma. SS are aggressive tumors with a median 5-year survival of 60-70% when localized disease but also a propensity for metastatic spread with 40-45% of patients developing metastasis within 5 years. It is considered a chemotherapy-sensitive sarcoma and treatment options are increasing. Herein, we present the outcomes of SS patients by systemic regimen and multimodality approach. Methods: This is a single institution, retrospective cohort of 79 patients with histopathologically confirmed SS treated at from 2004 to 2019. Clinical characteristics, treatment, response and survival were analyzed. We estimated medians of progression-free survival (PFS) and overall survival (OS) using the method of Kaplan-Meier along with the Log-Rank test. All tests were two-sided and statistical significance was considered when p<0.05. Results: Median follow-up was 3.7 years (range 3.13 to 4.33), 59.5% were women and median age at diagnosis was 41 (range 5-77). At presentation, 60 patients (75.9%) had localized disease and 19 (24.1%) presented with metastatic disease. Among the entire cohort the three-year OS rate was 78.9% (95%CI = 66.3-87.3) and five-year OS rate 68.7% (95%CI = 53.5-79.9). OS between localized disease (N = 45) and metastatic (N = 12) was not statistically significant (log-rank p = 0.098). When comparing different regimens, doxorubicin-based regimens (DBR) showed longest median PFS of 10.1 months (95%CI = 3.97-21.16), while pazopanib had a median PFS of 7.45 (95%CI = 2.63-12.3), high dose ifosfamide (HDI) 6.4 months (95%CI = 2.79-15.5) and trabectedin 3.12 months (95%CI = 0.99-6.97). Conversely, patients with metastatic disease treated with pazopanib experienced a median PFS of 11.47 months (95%CI = 2.63-32.9) while those treated with a DBR 8.15 months (95%CI = 1.08-35.8). Conclusions: SS is highly aggressive and, in our cohort, patients with local presentation had non-significant difference in OS to the metastatic disease, this could be due to a small sample size or the high probability for relapse this tumor has. Chemotherapy with DBRs showed superiority to other regimens and pazopanib showed to be slightly superior when evaluating only metastatic disease. Addition of pazopanib maintenance therapy may improve PFS and OS. Continuous evaluation of these patients with further inclusion of SS on immunotherapy is warranted.

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Effectiveness of online versus live multi-family psychoeducation group therapy for children and adolescents with mood or anxiety disorders: a pilot study

International Journal of Adolescent Medicine and Health ◽

10.1515/ijamh-2016-0069 ◽

2016 ◽

Vol 30 (4) ◽

Cited By ~ 3

Author(s):

Iman Sapru ◽

Sarosh Khalid-Khan ◽

Elaine Choi ◽

Nazanin Alavi ◽

Archana Patel ◽

...

Keyword(s):

Anxiety Disorder ◽

Group Therapy ◽

Anxiety Disorders ◽

Sample Size ◽

Small Sample Size ◽

Statistical Significance ◽

Relative Effectiveness ◽

Small Sample ◽

Rank Test ◽

Family Psychoeducation

Abstract Objective: [1] To highlight the effectiveness of multi-family psychoeducation group therapy (MFPGT) in children with mood or anxiety disorders; [2] to measure change in knowledge and awareness of mood and anxiety disorders in families and children; and [3] to compare the relative effectiveness of online compared to live MFPGT. Method: Participants included families of children (12 years or younger) referred with a mood or anxiety disorder to the Division of Child and Adolescent Psychiatry at Queen’s University (n=16) who were on a waitlist to see a psychiatrist. Change was measured through questionnaires for all parents before and after the program. Using SPSS v22, comparisons between the online (n=6) and live (n=10) groups were made using the Mann-Whitney U test and within group comparisons were made using Wilcoxon signed-rank test. Results: The online and live education groups showed similar overall improvements in knowledge acquisition and expressed emotion in participating families. However, statistical significance must be interpreted with caution due to the small sample size. Conclusions: Online MFPGT may be an effective way to increase knowledge, provide resources and support and build on skills thus giving individuals more control and confidence when dealing with a mood or anxiety disorder while on a waitlist. MFPGT showed equal efficacy in live and online groups, indicating that the online program has the potential to be a more convenient and accessible program for families. More research is needed with a greater sample size.

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Association of losartan use with outcomes in metastatic pancreatic cancer patients treated with chemotherapy.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e16738 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e16738-e16738

Author(s):

Jessica Allen ◽

Kathan Mehta ◽

Shrikant Anant ◽

Prasad Dandawate ◽

Anwaar Saeed ◽

...

Keyword(s):

Small Sample Size ◽

Metastatic Cancer ◽

Statistical Significance ◽

Objective Response ◽

Locally Advanced ◽

Small Sample ◽

Ductal Adenocarcinoma ◽

Control Group ◽

100Mg Dose ◽

Significant Difference

e16738 Background: A phase II trial has shown improved efficacy of neoadjuvant therapy when combined with losartan (by remodeling desmoplasia) in locally advanced pancreatic ductal adenocarcinoma (PDA). However, role of losartan is unknown in metastatic PDA. We examined the relationship between the use of the angiotensin II receptor antagonist, losartan, at time of diagnosis with clinical outcomes in metastatic PDA pts that received chemo. Methods: We retrospectively evaluated 114 metastatic PDA pts treated at our center between Jan 2000 and Nov 2019. We compared OS, PFS, objective response rate (ORR), and disease control rate (DCR) between pts using losartan at time of cancer diagnosis and a control group of pts not on losartan. A subanalysis was performed based on losartan dose: 100mg dose versus control pts. and based on chemo: FOLFIRINOX or gemcitabine+abraxane. Results: Table shows baseline demographics. No significant difference was found in OS [p = 0.455] or PFS [p = 0.919] in pts on losartan (median 274d, 83d) vs control (median 279d, 111d) [p = 0.466]. No significant difference was found in ORR [p = 0.621] or in DCR [p = 0.497]. No significant difference was found in OS [p = 0.771] or PFS [p = 0.064] in losartan pts (median 347d, 350d) vs control (median 333d, 101d) treated with FOLFIRINOX. No significant difference was found in OS [p = 0.916] or PFS [p = 0.341] in losartan (median 312d, 69d) vs control (median 221d, 136d) [p = 0.916] treated with gemcitabine+abraxane. No significant difference was found in OS [p = 0.727] or PFS [p = 0.790] in 100mg losartan pts (median 261d, 84d) vs control (median 279d, 111d). Conclusions: Pts on losartan at time of diagnosis had no significant difference in OS, PFS, ORR, DCR than control pts. However, a subanalysis of pts treated with FOLFIRINOX revealed a longer PFS with losartan than control but did not meet statistical significance, likely due to small sample size. To confirm if the benefit of losartan + FOLFIRINOX seen in neoadjuvant setting for locally advanced cancer also applies to metastatic cancer, our findings need to be validated in a larger cohort. [Table: see text]

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A retrospective comparison of contrast enhanced spectral mammography (CESM) to breast MRI in breast cancer detection: An initial study for sensitivity analysis.

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.26_suppl.7 ◽

2014 ◽

Vol 32 (26_suppl) ◽

pp. 7-7

Author(s):

Luna Li ◽

Kristin Brill ◽

Pauline Germaine ◽

Elizabeth Tinney ◽

Karen Hendershott ◽

...

Keyword(s):

Breast Cancer ◽

Cancer Detection ◽

Small Sample Size ◽

Statistical Significance ◽

Small Sample ◽

Breast Cancer Detection ◽

Contrast Enhanced ◽

Significant Difference ◽

Mean Size ◽

Index Cancer

7 Background: CESM is a new study using contrast and dual energy digital mammographic technology to detect contrast enhanced cancer that may be invisible on conventional mammogram. Limited studies have shown that adding CESM to diagnostic workup adjunct with mammogram and breast ultrasound does increase sensitivity for breast cancer detection. More studies are needed to compare the sensitivity of CESM to BMRI to further define the role of CESM in breast cancer diagnosis. Methods: This study involved 50 malignant breasts in 48 women retrospectively chosen from of 960 patients in our institution during the period of October 2012 to March 2014. Both CESM and BMRI were done for each patient within 30 days. The cancer diagnoses were confirmed by tissue diagnoses. The size of lesions was classified into three categories based on standard of breast cancer stages: 1 (0.2cm - < = 2 cm), 2 (2 cm < lesion < = 5 cm), 3 (> 5 cm). The enhancement intensity of both lesions and background has been quantified based on a scale of 0-3. Statistical significance was analyzed using T test for mean size of index cancer and mean score of enhancement intensity of background and lesions on CESM and BMRI. Sensitivity and positive predictive value (PPV) were calculated for both CESM and BMRI. Morphology consistence was calculated on both studies. Results: Both CESM and BMRI have sensitivity of 100% for breast cancer detection. CESM has a PPV of 98% versus 93% for BMRI. No statistical significance was identified on mean size of index cancer. The enhancement intensity of background and lesions is significantly higher on CESM than on BMRI (p < 0.01). The smallest cancer can be detected by both CESM and BMRI is less than 0.5 cm. Morphology consistence was 46/50 (92%). Conclusions: Our study indicates that CESM and BMRI have comparable high sensitivity on breast cancer detection. CESM has a higher PPV than BMRI that may indicate a better specificity (no significant difference due to the small sample size). Significantly less background enhancement intensity on CESM than on BMRI reflect an increased specificity. More studies need to be conducted for further evaluation.

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Phase II trial of neoadjuvant exemestane [EXE] and celecoxib [CELE] in breast cancer: Results of biomarkers

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.11056 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 11056-11056 ◽

Cited By ~ 1

Author(s):

C. L. Shapiro ◽

S. P. Povoski ◽

R. Jiminez ◽

J. Dehart ◽

S. Ottman ◽

...

Keyword(s):

Breast Cancer ◽

Core Biopsy ◽

Small Sample Size ◽

Statistical Significance ◽

Small Sample ◽

Rank Test ◽

Ki 67 ◽

Cancer History ◽

Cox 2 ◽

Tumor Measurements

11056 Background: Aromatase [CYP19] activity and expression is increased by prostaglandin E2, thus providing a rational for combining the COX-2 inhibitor, CELE, with an aromatase inhibitor. To evaluate the effects of these drugs on proliferation and other biomarkers, we conducted a neoadjuvant trial of EXE alone followed by the combination of EXE and CELE. The primary endpoint was the assessment of biomarkers and the secondary endpoint was toxicity. Methods: Clinical stages II/III, postmenopausal, estrogen [ER] and/or progesterone receptor [PR] positive, previously untreated, ECOG 0–1 were eligible. Excluded were inflammatory breast cancer, history of myocardial infarction, and documented allergy to aspirin, NSAIDs, or sulfonamides. After initial core biopsy pts received 8 weeks (wks) of EXE 25 mg daily. They then received a second core biopsy followed by 8 wks of EXE and CELE 400 mg twice daily. After 16 wks, pts had definitive surgery. Compliance was assessed by pill counts at study visists every 4 wks. At baseline, 8, and 16 wks, pts had tumor measurements by physical exam, mammogram, and ultrasound. A tissue microarray [TMA] was contructed and immunohistochemical [IHC] staining with commercially available antibodies for Ki-67, COX-2, HER-2, ER, and PR was performed. Two independent pathologists scored intensity and percentage of cells staining and were blinded to treatment and the timimg of specimen acquistion. Statistical analyses were performed using Wilcoxon signed-rank test Results: Twenty pts with a median age 62 (range 56–87) were enrolled. CELE was discontinued in 3 (15%) pts for grade 1 rash-1 pt; grade 1 creatinine elevation-1 pt; and grade 1 melena-1 pt. Three (15%) pts-partial response, 16 (80%)-stable disease, and 1 (5%)-progressive disease. None of the differences in biomarkers between 0 and 8 wks and 8 and 16 wks were significant. A trend toward decreasing mean Ki 67 was observed from 0 to 8 wks (20% vs 9%, p=0.19) and 8 to 16 wks (9% vs 7%, p=0.7) Conclusions: Neoadjuvant EXE followed by EXE/CELE was well tolerated with anti-tumor activity. Tumor cell proliferation decreased by about 50% during EXE, but small sample size precluded reaching statistical significance. Frozen tissue was collected and the results of CYP 19 mRNA expression will be presented. [Table: see text]

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Addition of ATG to Myeloablative Haplo Conditioning with Post-Transplantation Cyclophosphamide Might Decrease the Risk of Gvhd and TRM without Increasing the Risk of Relapse

Blood ◽

10.1182/blood.v128.22.5871.5871 ◽

2016 ◽

Vol 128 (22) ◽

pp. 5871-5871 ◽

Cited By ~ 2

Author(s):

Ghuzayel Al Dawsari ◽

Mona Fawzy Ramadan Hassanein ◽

Walid Rasheed ◽

Fahad Almohareb ◽

Naeem A. Chaudhri ◽

...

Keyword(s):

Sample Size ◽

Acute Gvhd ◽

Small Sample Size ◽

Statistical Significance ◽

Hemorrhagic Cystitis ◽

Conditioning Regimen ◽

Small Sample ◽

Significant Incidence ◽

Significant Difference ◽

Cmv Reactivation

Abstract Introduction: The use of a Myeloablative (MA) regimen followed bypost-transplantation high dose Cyclophosphamide (PT-CY) has been adopted to overcome the increased relapse risk following nonmyeloablative conditioning regimen and unmanipulated Haploidentical Bone Marrow Transplantation, in patients with high-risk hematological malignancies, with acceptable TRM and risk of GVHD. We added ATG to our Myeloablative regimen with PT-CY after noticing significant incidence of grade II-IV aGVHD with the first few cases. Here we compare the outcomes of the 12 patients who received ATG to the outcomes of the first 11 patients who were transplanted without ATG. Patients and Methods: our haploidentical program was started in 2013 as a phase I/II prospective clinical trial. After reviewing the first 11 cases enrolled on the trial (MA regimen with PT-CY, without ATG), we noticed significant incidence of high grade aGVHD (54.55%). We amended our protocol in early 2015. Rabbit ATG was added at a dose of 3 mg/kg (1.5 mg/kg day -3 and day -2) to our conditioning regimen [thiotepa (5mg/kg/day on day -8 and -7), busulfan (3.2mg/kg/day IV day-6, -5 and -4), fludarabine (50mg/m2/day on day -6, -5 and -4 )] or [TBI 1000 cGy (200cGy twice a day on days -10, -9 and one dose on day -8), fludarabine (30mg/m2/day on Days -7, -6, -5 and -4)]. Graft-versus-host disease (GVHD) prophylaxis consisted of PT-CY (50mg/kg/day) on days +3 and +5, cyclosporine (starting day +4), and mycophenolate mofetil (starting day +1). Table 1 summarizes the disease-type and disease-status at transplant. Patient characteristics were comparable at baseline between the 2 groups. Results (Table 2): We enrolled patients with high risk hematologic malignancies in need for SCT but have no matched donor (MSD, MUD). Despite the small sample size, our results showed a statistically significant difference in the rate of acute GVHD between the 2 groups (p= 0.0161) in favor of the ATG group, chronic GVHD was more frequent in the non-ATG group however the difference did not reach statistical significance probably due to the small sample size. There was no statistically-significant difference in the risk of relapse, CMV reactivation or Hemorrhagic cystitis between the 2 groups. However, there was a trend of higher relapse rate (33.3% vs 18.18%), a higher rate of Hemorrhagic cystitis (50% vs 18.18%) and a higher rate of CMV reactivation (100% vs 81.82%) in the ATG group. The cumulative incidence of TRM at day 100 was in favor of the ATG group (figure 1), with a trend toward a better DFS in these patients 6 months post-transplant (figure 2). To be noted the follow up period was shorter for the ATG group because ATG was added later on. Figure 3 shows the survival for ATG vs non ATG group. Conclusion: The use of ATG with myeloablative Haplo conditioning can significantly reduce the risk of acute GVHD and early TRM. We have seen more relapses, higher rate of CMV reactivation, and hemorrhagic cystitis with the addition of ATG but these did not reach statistical significance probably due to the small sample size. A lower dose of ATG might be the way to go to strike a careful balance and improve the outcomes of myeloablative haploidentical transplant. Disclosures No relevant conflicts of interest to declare.

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NI-19 Use of 11C-methionine PET for decision of discontinuation of adjuvant chemotherapy with temozolomide

Neuro-Oncology Advances ◽

10.1093/noajnl/vdaa143.062 ◽

2020 ◽

Vol 2 (Supplement_3) ◽

pp. ii14-ii14

Author(s):

Takaaki Beppu ◽

Yuichi Sato ◽

Toshiaki Sasaki ◽

Kazunori Terasaki ◽

Kuniaki Ogasawara

Keyword(s):

Adjuvant Chemotherapy ◽

Small Sample Size ◽

Standardized Uptake Value ◽

Progression Free Survival ◽

Residual Tumor ◽

Small Sample ◽

Tumor Type ◽

Diffuse Astrocytoma ◽

Significant Difference ◽

Met Pet

Abstract Background: The aim was to clarify whether positron emission tomography with 11C-methyl-L-methionine (met-PET) is useful to decide on discontinuation of TMZ-adjuvant therapy in patients with residual diffuse astrocytic tumor. Methods: Subjects were 44 patients with residual tumor comprising 17 with IDH1-mutant diffuse astrocytoma (DA), 13 with IDH1-mutant anaplastic astrocytoma (AA), and 14 with IDH1-wild glioblastoma (GB). All patients received TMZ-adjuvant chemotherapy (median, 12 courses), and whether to discontinue or continue TMZ-adjuvant chemotherapy was decided on the basis of the tumor-to-normal ratio in standardized uptake value from met-PET (T/N); patients with T/N < 1.6 immediately discontinued TMZ, and patients with T/N > 1.6 were either to continued or discontinued TMZ. Progression-free survival (PFS) was compared between patients with T/N > 1.6 and T/N < 1.6 in each tumor type. Median observation period was 434 days after met-PET scanning. Results: The number of patient who underwent recurrence was 10 in DA, 7 in AA, and 11 in GB. All patients showing T/N > 1.6 underwent tumor recurrence. PFS was significantly longer in patients with T/N < 1.6 than T/N > 1.6 in DA and AA (p < 0.01 in both types), but was no significant difference between 2 groups in GB (p = 0.06). Sixteen of 17 patients (94%) in DA and AA showed recurrence from residual tumor, whereas 4 of 11 patients (36%) in GB showed recurrent tumor at remote regions which were different from residual tumor. Conclusions: The present study suggested that met-PET is beneficial to decide to discontinue adjuvant chemotherapy with TMZ in patients with residual tumors of DA and AA, but not useful for patients with GB. Reasons for unsuccessful results in GB might have been small sample size, failure of establishing the cut off value in T/N, recurrences at remote regions where not be assessed by met-PET.

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1611. Evaluating Clinical Outcomes and Efficacy of Daptomycin in Combination with a Beta-Lactam for the Treatment of Vancomycin-Resistant Enterococcus (VRE) Bacteremia

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.1791 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S799-S800

Author(s):

Nerea Irusta ◽

Ana Vega ◽

Yoichiro Natori ◽

Lilian M Abbo ◽

...

Keyword(s):

Clinical Outcomes ◽

Primary Outcome ◽

Small Sample Size ◽

Univariate Analysis ◽

Small Sample ◽

Significant Difference ◽

Vancomycin Resistant ◽

Secondary Outcomes ◽

Related Mortality

Abstract Background In-vitro studies have shown synergistic bactericidal activity with daptomycin (DAP) plus β-lactam antimicrobials against vancomycin resistant enterococci (VRE). There is a paucity of data regarding clinical outcomes with this combination in VRE bloodstream infections (BSI). The purpose of this study was to assess the efficacy of DAP plus a β-lactam with in-vitro activity vs. other therapies for treatment of VRE BSI. Methods IRB-approved, single-center, retrospective study of patients with VRE BSI from 01/2018-09/2019. Patients were excluded if < 18 years old, pregnant, or incarcerated. The primary outcome was time-to-microbiological clearance. Secondary outcomes included infection-related mortality, 30-day all-cause mortality, and incidence of recurrent BSI within 30 days of index culture. Targeted DAP doses were ≥ 8mg/kg and based on MIC. Factors associated with significance for outcomes, via univariate analysis, were evaluated with multivariable logistic regression (MLR), removed in a backward-step approach. Results A total of 85 patients were included, 23 of which received DAP plus a β-lactam. The comparator arm included linezolid or DAP monotherapy. Patients with combination therapy had significantly higher Charlson Comorbidity Index (CCI) (p=0.013) and numerically higher Pitt Bacteremia scores (PBS) (p=0.087) (Table 1). There was no difference seen in the primary outcome (Table 2). Secondary outcomes are provided in Table 2. The presence of polymicrobial infection and higher PBS were significantly associated with infection-related mortality (p=0.008 and p=0.005, respectively) by MLR. A Mann Whitney U test indicated that presence of infection-related mortality was greater for patients with higher MICS (U=20.5, p=0.06). The presence of an underlying source may be related to recurrence of BSI (p=0.075). Table 1: Patient Characteristics Table 2. Primary and Secondary Outcomes Conclusion We did not find a significant difference in time-to-microbiological clearance, although patients treated with DAP and a β-lactam had higher CCI and PBS. These results are limited by retrospective design, small sample size, and potential selection bias. Prospective randomized studies are needed to further validate these findings. Disclosures All Authors: No reported disclosures

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Combination of AST to ALT and neutrophils to lymphocytes ratios as predictors of locally advanced disease in patients with bladder cancer subjected to radical cystectomy: Results from a single-institutional series

Urologia Journal ◽

10.1177/03915603211035191 ◽

2021 ◽

pp. 039156032110351

Author(s):

Alessandro Uleri ◽

Rodolfo Hurle ◽

Roberto Contieri ◽

Pietro Diana ◽

Nicolòmaria Buffi ◽

...

Keyword(s):

Bladder Cancer ◽

Radical Cystectomy ◽

Advanced Disease ◽

Independent Predictor ◽

Small Sample Size ◽

Statistical Significance ◽

Locally Advanced ◽

Small Sample ◽

Locally Advanced Disease ◽

Increased Risk

Background: Bladder cancer (BC) staging is challenging. There is an important need for available and affordable predictors to assess, in combination with imaging, the presence of locally-advanced disease. Objective: To determine the role of the De Ritis ratio (DRR) and neutrophils to lymphocytes ratio (NLR) in the prediction of locally-advanced disease defined as the presence of extravescical extension (pT ⩾ 3) and/or lymph node metastases (LNM) in patients with BC treated with radical cystectomy (RC). Methods: We retrospectively analyzed clinical and pathological data of 139 consecutive patients who underwent RC at our institution. Logistic regression models (LRMs) were fitted to test the above-mentioned outcomes. Results: A total of 139 consecutive patients underwent RC at our institution. Eighty-six (61.9%) patients had a locally-advanced disease. NLR (2.53 and 3.07; p = 0.005) and DRR (1 and 1.17; p = 0.01) were significantly higher in patients with locally-advanced disease as compared to organ-confined disease. In multivariable LRMs, an increasing DRR was an independent predictor of locally-advanced disease (OR = 3.91; 95% CI: 1.282–11.916; p = 0.017). Similarly, an increasing NLR was independently related to presence of locally-advanced disease (OR = 1.28; 95% CI: 1.027–1.591; p = 0.028). In univariate LRMs, patients with DRR > 1.21 had a higher risk of locally advanced disease (OR = 2.83; 95% CI: 1.312–6.128; p = 0.008). Similarly, in patients with NLR > 3.47 there was an increased risk of locally advanced disease (OR = 3.02; 95% CI: 1.374–6.651; p = 0.006). In multivariable LRMs, a DRR > 1.21 was an independent predictor of locally advanced disease (OR = 2.66; 95% CI: 1.12–6.35; p = 0.027). Similarly, an NLR > 3.47 was independently related to presence of locally advanced disease (OR = 2.24; 95% CI: 0.95–5.25; p = 0.065). No other covariates such as gender, BMI, neoadjuvant chemotherapy or diabetes reached statistical significance. The AUC of the multivariate LRM to assess the risk of locally advanced disease was 0.707 (95% CI: 0.623–0.795). Limitations include the retrospective nature of the study and the relatively small sample size.

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Perioperative Outcomes Following Kidney-Pancreas Transplantation in Alberta, Canada: Research Letter

Canadian Journal of Kidney Health and Disease ◽

10.1177/20543581211029389 ◽

2021 ◽

Vol 8 ◽

pp. 205435812110293

Author(s):

Danielle E. Fox ◽

Robert R. Quinn ◽

Paul E. Ronksley ◽

Tyrone G. Harrison ◽

Hude Quan ◽

...

Keyword(s):

Patient Outcomes ◽

Postoperative Care ◽

Pancreas Transplantation ◽

Type I Diabetes ◽

Small Sample Size ◽

Small Sample ◽

Perioperative Outcomes ◽

Type I ◽

Patient Safety Indicators ◽

Significant Difference

Background: Simultaneous kidney-pancreas transplantation (SPK) has benefits for patients with kidney failure and type I diabetes mellitus, but is associated with greater perioperative risk compared with kidney-alone transplantation. Postoperative care settings for SPK recipients vary across Canada and may have implications for patient outcomes and hospital resource use. Objective: To compare outcomes following SPK transplantation between patients receiving postoperative care in the intensive care unit (ICU) compared with the ward. Design: Retrospective cohort study using administrative health data. Setting: In Alberta, the 2 transplant centers (Calgary and Edmonton) have different protocols for routine postoperative care of SPK recipients. In Edmonton, SPK recipients are routinely transferred to the ICU, whereas in Calgary, SPK recipients are transferred to the ward. Patients: 129 adult SPK recipients (2002-2019). Measurements: Data from the Canadian Institute for Health Information Discharge Abstract Database (CIHI-DAD) were used to identify SPK recipients (procedure codes) and the outcomes of inpatient mortality, length of initial hospital stay (LOS), and the occurrence of 16 different patient safety indicators (PSIs). Methods: We followed SPK recipients from the admission date of their transplant hospitalization until the first of hospital discharge or death. Unadjusted quantile regression was used to determine differences in LOS, and age- and sex-adjusted marginal probabilities were used to determine differences in PSIs between centers. Results: There were no perioperative deaths and no major differences in the demographic characteristics between the centers. The majority of the SPK transplants were performed in Edmonton (n = 82, 64%). All SPK recipients in Edmonton were admitted to the ICU postoperatively, compared with only 11% in Calgary. There was no statistically significant difference in the LOS or probability of a PSI between the 2 centers (LOS for Edmonton vs Calgary:16 vs 13 days, P = .12; PSIs for Edmonton vs Calgary: 60%, 95% confidence interval [CI] = 0.50-0.71 vs 44%, 95% CI = 0.29-0.59, P = .08). Limitations: This study was conducted using administrative data and is limited by variable availability. The small sample size limited precision of estimated differences between type of postoperative care. Conclusions: Following SPK transplantation, we found no difference in inpatient outcomes for recipients who received routine postoperative ICU care compared with ward care. Further research using larger data sets and interventional study designs is needed to better understand the implications of postoperative care settings on patient outcomes and health care resource utilization.

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Internet-based intervention compared to brief intervention for smoking cessation in Brazil: a pilot study (Preprint)

10.2196/preprints.30327 ◽

2021 ◽

Author(s):

Nathalia Machado ◽

Henrique Gomide ◽

Heder Bernardino ◽

Telmo Ronzani

Keyword(s):

Smoking Cessation ◽

Brief Intervention ◽

Small Sample Size ◽

Statistical Significance ◽

Healthcare Providers ◽

Intervention Group ◽

Small Sample ◽

The Internet ◽

Intention To Treat ◽

Internet Based Intervention

BACKGROUND Smoking is still the leading cause of preventable death. Governments and healthcare providers should make available more and accessible resources to help tobacco users stop. OBJECTIVE This study describes a pilot longitudinal study that evaluated the efficacy of a computerized intervention compared to the brief intervention for smoking cessation among Brazilians. METHODS Smokers were recruited and randomly assigned to one of the two intervention groups. RESULTS The results showed similar rates of cessation and reduction for both intervention groups. The internet-based intervention was a little more effective for smoking cessation, while the brief intervention was more effective in reducing the number of cigarettes smoked per day. Despite this, this difference was small and had no statistical significance even after adjusting for intention-to-treat analysis. These results should be interpreted with caution, especially due to the small sample size. CONCLUSIONS Forty-nine smokers were enrolled in this study (25 in the brief intervention group; 24 in the internet-based intervention group). The mean age was 44.46 years old; most were male (59.2%), had elementary school (44.9%), smoked an average of 14.5 cigarettes per day, had a mean score of 4.65 for nicotine dependence, and score of 5.7 for motivation to quit. Measures were drawn from comparing cessation rate, motivation score and sought treatment between groups. Thirty-five participants answered the follow up 1 and 19 answered to the second.

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