Sample Size Calculations in Clinical Research: Third Edition

Chow, Shein‐Chung; Shao, Jiayi; Wang, Hansheng; Lokhnygina, Yuliya

doi:10.1201/9781315183084

Cited by 372 publications

(209 citation statements)

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“…A post hoc analysis comparing two proportions for evaluation of noninferiority was performed to calculate the power of our analysis in detecting noninferiority between the proportion of complications in both groups 12 .…”

Section: Overlapping S U R G E Ry I N T H E a M B U L Ato Ry Orthopaementioning

confidence: 99%

Overlapping Surgery in the Ambulatory Orthopaedic Setting

Zhang

Sing

Dang

et al. 2016

The Journal of Bone and Joint Surgery

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Section: Overlapping S U R G E Ry I N T H E a M B U L Ato Ry Orthopaementioning

confidence: 99%

Overlapping Surgery in the Ambulatory Orthopaedic Setting

Zhang

Sing

Dang

et al. 2016

The Journal of Bone and Joint Surgery

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“…The required study sample size was calculated to identify differences in plaque control effects between the intervention and control groups 27,28 . The calculation of the effective sample size considering a 1:1 allocation at a statistical significance level ⍺=0.05, Z⍺ /2 =1.96, and statistical test power Z β =0.84 found that 20 people were needed in each group.…”

Section: Samplementioning

confidence: 99%

Effect of an oral healthcare program on gingival health status in rural areas of South Korea

Lee

Kim

Chung

et al. 2017

Rural Remote Health

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Introduction: The purpose of this study was to analyze the effects of an oral health care program administered at rural public health subcenters on oral hygiene status and bleeding on probing (BOP) scores among Korean rural residents older than 40 years. Methods: Residents older than 40 years living in two rural areas were allocated randomly by order of visit into an intervention group (n=23) and control group (n=23). Changes in plaque and BOP score were analyzed between the groups using repeatedmeasures ANOVA. Hierarchical multiple regression analysis was conducted to identify factors affecting changes in BOP score. Results: The BoP score decreased by 22.87 in the intervention group and 0.27 in the control group between baseline and the eighth week (p<0.001). Multiple regression analysis showed that the change in BoP score (∆BoP score) increased significantly with an increase in the reduction of the plaque (PHP) index (∆PHP index) (t=-2.174, p<0.05) and increased significantly more in the intervention group than in the control group (t=2.143, p<0.05). Conclusions: Professional care and continuous oral health education for 8 weeks prior to scaling among adults older than 40 years living in rural environments resulted in a change in oral health behaviors and a substantial reduction in gingival bleeding.

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“…Considering a drop-out rate of 20%, a total of 322 subjects were planned to be randomized for the study. Sample Size was calculated by using the power analysis of following test for non-inferiority by normal approximation [25] ( ) CI. Categorical variables were presented with number of exposed subjects, and number (N) with percentages.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of Safety and Efficacy of Glaritus<sup>&reg;</sup> versus Lantus<sup>&reg;</sup> in Combination with Insulin Lispro among Adults with Type 1 Diabetes Mellitus-Phase IV Study

Puppalwar¹,

Sawant²,

Silgiri³

et al. 2017

OJEMD

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Objective: The present study assessed safety and efficacy of Glaritus® among adults with Type 1 Diabetes Mellitus (T1DM). Methodology: This prospective, randomized, multicenter, comparative, non-inferiority, open-label, parallel group, phase IV study was conducted in 14 study centers in India. Subjects were randomly allocated to receive either Glaritus® or Lantus® for 12 weeks. Each week, the dose of insulin was titrated to maintain target fasting blood glucose (FBG) level range of 80 -120 mg/dL. Results: A total of 171 subjects were randomized (Glaritus® arm-86; Lantus® arm-85) and 161 subjects completed the study. The mean change in the glycosylated haemoglobin (HbA1c) levels from visit 3 (baseline) to visit 6 (end of trial) in Glaritus® arm was −0.69 ± 1.81 and in Lantus® arm was −0.53 ± 1.94. The mean change in glucose levels between week 1 and end of week 11 in Glaritus® arm was −8.81 ± 34.57 and in Lantus® arm was −5.28 ± 30. At least one hypoglycemic episode was experienced by 27.2% subjects of Glaritus® arm and 28.6% subjects of Lantus® arm. A total of 24 adverse events (AEs) such as pain, pyrexia, few infection related including urinary tract infections, metabolic related such as decreased appetite, musculoskeletal, neurological and skin related were re-

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Sample Size Calculations in Clinical Research: Third Edition

Cited by 372 publications

References 0 publications

Overlapping Surgery in the Ambulatory Orthopaedic Setting

Overlapping Surgery in the Ambulatory Orthopaedic Setting

Effect of an oral healthcare program on gingival health status in rural areas of South Korea

Evaluation of Safety and Efficacy of Glaritus<sup>&reg;</sup> versus Lantus<sup>&reg;</sup> in Combination with Insulin Lispro among Adults with Type 1 Diabetes Mellitus-Phase IV Study

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Sample Size Calculations in Clinical Research: Third Edition

Cited by 372 publications

References 0 publications

Overlapping Surgery in the Ambulatory Orthopaedic Setting

Overlapping Surgery in the Ambulatory Orthopaedic Setting

Effect of an oral healthcare program on gingival health status in rural areas of South Korea

Evaluation of Safety and Efficacy of Glaritus&lt;sup&gt;&amp;reg;&lt;/sup&gt; versus Lantus&lt;sup&gt;&amp;reg;&lt;/sup&gt; in Combination with Insulin Lispro among Adults with Type 1 Diabetes Mellitus-Phase IV Study

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Evaluation of Safety and Efficacy of Glaritus<sup>®</sup> versus Lantus<sup>®</sup> in Combination with Insulin Lispro among Adults with Type 1 Diabetes Mellitus-Phase IV Study