scholarly journals The role of poultry transfers in diet diversity: A cluster randomized intent to treat analysis

Food Policy ◽  
2022 ◽  
Vol 107 ◽  
pp. 102212
Author(s):  
Harold Alderman ◽  
Daniel O. Gilligan ◽  
Jessica Leight ◽  
Michael Mulford ◽  
Heleene Tambet
Keyword(s):  
Diet Diversity ◽  
Cluster Randomized ◽  
Intent To Treat ◽  
Treat Analysis

Intent-to-treat analysis of cluster randomized trials when clusters report unidentifiable outcome proportions

2020 ◽  
Vol 17 (6) ◽  
pp. 627-636
Author(s):  
Stacia M DeSantis ◽  
Ruosha Li ◽  
Yefei Zhang ◽  
Xueying Wang ◽  
Sally W Vernon ◽  
...  
Keyword(s):  
Randomized Trials ◽  
The Novel ◽  
Cluster Randomized Trials ◽  
Randomized Controlled ◽  
Novel Approach ◽  
Cluster Randomized ◽  
Intent To Treat ◽  
Risk Ratios ◽  
Cluster Level ◽  
Treat Analysis

Background Cluster randomized trials are designed to evaluate interventions at the cluster or group level. When clusters are randomized but some clusters report no or non-analyzable data, intent-to-treat analysis, the gold standard for the analysis of randomized controlled trials, can be compromised. This article presents a very flexible statistical methodology for cluster randomized trials whose outcome is a cluster-level proportion (e.g. proportion from a cluster reporting an event) in the setting where clusters report non-analyzable data (which in general could be due to nonadherence, dropout, missingness, etc.). The approach is motivated by a previously published stratified randomized controlled trial called, “The Randomized Recruitment Intervention Trial (RECRUIT),” designed to examine the effectiveness of a trust-based continuous quality improvement intervention on increasing minority recruitment into clinical trials (ClinicalTrials.gov Identifier: NCT01911208). Methods The novel approach exploits the use of generalized estimating equations for cluster-level reports, such that all clusters randomized at baseline are able to be analyzed, and intervention effects are presented as risk ratios. Simulation studies under different outcome missingness scenarios and a variety of intra-cluster correlations are conducted. A comparative analysis of the method with imputation and per protocol approaches for RECRUIT is presented. Results Simulation results show the novel approach produces unbiased and efficient estimates of the intervention effect that maintain the nominal type I error rate. Application to RECRUIT shows similar effect sizes when compared to the imputation and per protocol approach. Conclusion The article demonstrates that an innovative bivariate generalized estimating equations framework allows one to implement an intent-to-treat analysis to obtain risk ratios or odds ratios, for a variety of cluster randomized designs.

scholarly journals Effectiveness of exercise at workplace in physical fitness: uncontrolled randomized study

2014 ◽  
Vol 12 (1) ◽  
pp. 55-60 ◽  
Author(s):  
Antônio José Grande ◽  
Valter Silva ◽  
Sérgio Alencar Parra
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Randomized Study ◽  
Exercise Program ◽  
Employee Health ◽  
Fat Percentage ◽  
Academic Organizations ◽  
Health Related ◽  
Intent To Treat ◽  
Treat Analysis

Objective : To investigate the effectiveness of workplace exercise for employee health by means of health-related physical activity components. Methods : A randomized uncontrolled study with 20 workers was carried out during three months to evaluate a workplace exercise program. The selected outcomes were flexibility, body mass, fat percentage, lean mass, blood pressure, and heart rate. For statistical analysis, the paired t test and the intent-to-treat analysis were used. Results : There was a significant increase in weight, fat percentage, blood pressure, and heart rate. However the clinical significance was 10% in the size of the effect. Conclusion : The changes verified in the outcomes analyzed were not significant; the variables are within normality ranges proposed by academic organizations

Blood tests to predict one- to two-year survival of patients with difficult cancers.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16158-e16158
Author(s):  
Robert L. De Jager ◽  
Howard Bruckner ◽  
Fred Bassali ◽  
Elisheva Dusowitz ◽  
AJ Book ◽  
...  
Keyword(s):  
High Risk ◽  
Hospice Care ◽  
Intrahepatic Bile Duct ◽  
Stage Iv ◽  
Neutrophil Lymphocyte Ratio ◽  
Blood Tests ◽  
Kaplan Meier ◽  
Risk Patients ◽  
Intent To Treat ◽  
Treat Analysis

e16158 Background: A sequence of drug combinations produces > 1 median (M) -strong 2-year (yr) survival (S) (Bruckner et al AACR 14 Antica Res (ACR) 16, 18 SIGO 19). Trials included high-risk patients (pts). Each initial series has 5-yr Ss, after pts were referred for hospice care. Prognostic ALAN blood tests (Ts) have been validated for stage IV (Adv) Cholangiocarcinoma (CCA) (Salati et al EuJCa18). Other Ts predict unexpected favorable (F) S of pts with gastric ca, PS 2-3. Bruckner et al JAMA, 82); but, there is little known about Ts for resistant (R) Ca. Methods: Planned Kaplan-Meier intent to treat analysis to find Ts that: expand eligibility (El) for therapy; identify biomarkers that predict therapy can prolong S and identify new hypotheses for therapy. El pts have:R to test drugs, Pancreatic (PC), Intrahepatic bile duct, CCA, Colon, CRC and new (N) APC. All series: -/+ high risk, -/+ aged, PS 0-2. El: Helsinki criteria- consent, recovered from severe (gr3) toxicity; able to reach office, -/+ help, and S > 6 wks. Inel: CNS involved, IV needed, F clinical factors predict 1 yr MST. Ts include A.L.A.N. scores, (AS) (Salati ibid) and other blood Ts (ACR ibid, Lavin et al CTR 82) Therapy GFLIO in mg/M2: gemcitabine 500, leucovorin 180, fluorouracil 1200, 24 hr infusion. Irinotecan 80 D2 Oxaliplatin 40. Then for progression (pg), add docetaxel 20-25, except CRC mitomycin C 4-6; next pg add cetuximab, except APC or KRAS-M, weekly, and next pg replace cetuximab with bevacizumab 10mg/kg ibid ACR 16. Results: At all ages, overall (O) S is > 1 yr for RCRC, and NAPC and sets with any 1 F or UnF T other than < 3.1 Albumin (Alb) or < 2.1 lymph/monocyte ratio (LMR) b For CCA, 17R/16N, OMS > 2 yrs 66% of pts and ≥ 2 yrs for all test sets except UnF, 26% of pts, MS 17 mos, with low Alb. For CRC: 50R OMS is 16.5 mos; 42% S 2 yrs, Fav Ts: MS > ̃ 2yrs, 39-82% of pts have FTs; Neutrophil Lymphocyte Ratio (NLR); < 3.1, 61% S 2 yrs, p < .02; Lymphs > 1.5, 53% S 2 yrs, p < .02; AS 0; 59% S 2 yrs, p < .06; Platelets < 300,000, 54% S 2 yrs, p < .06; Alb: ≥ 3.5, 48% S 2 yrs, p < .11. For N-APC: 53 pts, OS is 14.5 mos and > 12 mos in sets with any 1 UnF T other than Alb or LMR. FTs: MST 16.4-18 mos. 34-77% of pts have FTs; Alb ≥ 3.5, 34% S 2 yrs, p < 0.001; WBC < 10, 29% S 2 yrs, p < .06; AS 0-2, 35% S 2 yrs, p 2.7E-7. For R-PC: 53 pts, OS is 12 mos for 44% of pts, FTs: MST 13.6-17 mos, 21-70% of pts have FTs: Alb ≥ 3.5 30% S 2 yrs, p .0004; AS: 0, 41% S 2 yrs, p .0006; NLR < 3, 37% S 2 yrs, p < .02. GFLIO’s < 5% gr3 induction toxicity, is reversible, with no hospitalization, neutropenic fever or gr3 neuropathy. Conclusions: Robust Ts identify many difficult pts with median > 1 and testable prospective > 2 yr rates of S. Ts warrant development: validation with GFLIO and other therapy and other cancers; to improve Ts, models for eligibility and geriatric criteria; to identify false -/+ trials; and personalize trials to correct UnF Ts. FTs, with GFLIO, can change prognosis and practice for > 50% of pts now advised “against” any therapy due to a clinical estimate of “less than 6 -10 mos to live.” Clinical trial information: NCT01905150.

Mediating role of screen media use on adolescents' total sleep time: A cluster‐randomized controlled trial for physical activity and sedentary behaviour

2020 ◽  
Vol 46 (3) ◽  
pp. 381-389
Author(s):  
Margarethe Thaisi Garro Knebel ◽  
Adriano Ferreti Borgatto ◽  
Marcus Vinicius Veber Lopes ◽  
Priscila Cristina Santos ◽  
Thiago Sousa Matias ◽  
...  
Keyword(s):  
Physical Activity ◽  
Total Sleep Time ◽  
Controlled Trial ◽  
Sleep Time ◽  
Mediating Role ◽  
Screen Media ◽  
Randomized Controlled ◽  
Screen Media Use ◽  
Cluster Randomized

Efficacy versus intent-to-treat analysis in the canadian American ticlopidine study

1990 ◽  
Vol 11 (4) ◽  
pp. 259
Author(s):  
Robin S. Roberts ◽  
Jane Sicurella ◽  
Michael Gent
Keyword(s):  
Intent To Treat ◽  
Treat Analysis

Randomized Trial of Radiotherapy Versus Concurrent Chemoradiotherapy Followed by Adjuvant Chemotherapy in Patients With American Joint Committee on Cancer/International Union Against Cancer Stage III and IV Nasopharyngeal Cancer of the Endemic Variety

2005 ◽  
Vol 23 (27) ◽  
pp. 6730-6738 ◽  
Author(s):  
Joseph Wee ◽  
Eng Huat Tan ◽  
Bee Choo Tai ◽  
Hwee Bee Wong ◽  
Swan Swan Leong ◽  
...  
Keyword(s):  
Distant Metastasis ◽  
Nasopharyngeal Cancer ◽  
Disease Free Survival ◽  
Free Survival ◽  
The Difference ◽  
Intent To Treat ◽  
To Receive ◽  
Disease Free ◽  
Treat Analysis

Purpose The Intergroup 00-99 Trial for nasopharyngeal cancer (NPC) showed a benefit of adding chemotherapy to radiotherapy. However, there were controversies regarding the applicability of the results to patients in endemic regions. This study aims to confirm the findings of the 00-99 Trial and its applicability to patients with endemic NPC. Patients and Methods Between September 1997 and May 2003, 221 patients were randomly assigned to receive radiotherapy (RT) alone (n = 110) or chemoradiotherapy (CRT; n = 111). Patients in both arms received 70 Gy in 7 weeks using standard RT portals and techniques. Patients on CRT received concurrent cisplatin (25 mg/m2 on days 1 to 4) on weeks 1, 4, and 7 of RT and adjuvant cisplatin (20 mg/m2 on days 1 to 4) and fluorouracil (1,000 mg/m2 on days 1 to 4) every 4 weeks (weeks 11, 15, and 19) for three cycles after completion of RT. All patients were analyzed by intent-to-treat analysis. The median follow-up time was 3.2 years. Results Distant metastasis occurred in 38 patients on RT alone and 18 patients on CRT. The difference in 2-year cumulative incidence was 17% (95% CI, 14% to 20%; P = .0029). The hazard ratio (HR) for disease-free survival was 0.57 (95% CI, 0.38 to 0.87; P = .0093). The 2- and 3-year overall survival (OS) rates were 78% and 85% and 65% and 80% for RT alone and CRT, respectively. The HR for OS was 0.51 (95% CI, 0.31 to 0.81; P = .0061). Conclusion This report confirms the findings of the Intergroup 00-99 Trial and demonstrates its applicability to endemic NPC. This study also confirms that chemotherapy improves the distant metastasis control rate in NPC.

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