Statistical analysis plan
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INTRODUCTION: Intravenous (IV) fluid is a key intervention in the management of septic shock. The benefits and harms of lower versus higher fluid volumes are unknown and thus clinical equipoise exists. We describe the protocol and detailed statistical analysis plan for the conservative versus liberal approach to fluid therapy of septic shock in the Intensive Care (CLASSIC) trial. The aim of the CLASSIC trial is to assess benefits and harms of IV fluid restriction versus standard care in adult intensive care unit (ICU) patients with septic shock. METHODS: CLASSIC trial is an investigator-initiated, international, randomised, stratified, and analyst-blinded trial. We will allocate 1554 adult patients with septic shock, who are planned to be or are admitted to an ICU, to IV fluid restriction versus standard care. The primary outcome is mortality at day 90. Secondary outcomes are serious adverse events (SAEs), serious adverse reactions (SARs), days alive at day 90 without life support, days alive and out of the hospital at day 90 and mortality, health-related quality of life (HRQoL), and cognitive function at 1 year. We will conduct the statistical analyses according to a pre-defined statistical analysis plan, including three interim analyses. For the primary analysis, we will use logistic regression adjusted for the stratification variables comparing the two interventions in the intention-to-treat (ITT) population. DISCUSSION: The CLASSIC trial results will provide important evidence to guide clinicians' choice regarding the IV fluid therapy in adults with septic shock.
- MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- interpretace statistických dat MeSH
- klinické protokoly * MeSH
- kognice MeSH
- kvalita života MeSH
- lidé středního věku MeSH
- lidé MeSH
- logistické modely MeSH
- péče o pacienty v kritickém stavu MeSH
- pragmatické klinické studie jako téma MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- septický šok mortalita psychologie terapie MeSH
- tekutinová terapie škodlivé účinky metody MeSH
- výsledek terapie MeSH
- výzkumný projekt MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
... Bounds When -- There Are No Events 49 -- 2.12 Sample Size Calculations Are Determined by the -- Analysis ... ... - 5.16 Assess the Errors in Calibration Due to Inverse -- Regression 125 -- Design, Conduct, and Analysis ... ... Follows Design 137 -- 6.7 Plan to Graph the Results of an Analysis 139 -- 6.8 Distinguish Between Design ... ... Structure and Treatment -- Structure 142 -- 6.9 Make Hierarchical Analyses the Default Analysis 143 ... ... CONTENTS xi -- 6.10 Distinguish Between Nested and Crossed Designs— -- Not Always Easy 145 -- 6.11 Plan ...
Wiley series in probability and statistics
1st ed. xviii, 221 s.
PURPOSE: The study aimed to analyze the dose-volume profiles of 3-dimensional radiation therapy (3D-CRT) and intensity modulated RT (IMRT) in the treatment of prostate carcinoma and to specify the profiles responsible for the development of gastrointestinal (GI) toxicity. METHODS AND MATERIALS: In the period 1997 to 2007, 483 patients with prostate carcinoma in stage T1-3 N0 (pN0) M0 were treated with definitive RT. Two groups of patients were defined for the analysis: the 3D-CRT group (n=305 patients) and the IMRT group (n=178 patients). In the entire cohort of 483 patients, the median follow-up time reached 4.4 years (range, 2.0-11.7 years). The cumulative absolute and relative volumes of irradiated rectum exposed to a given dose (area under the dose-volume curve, AUC) were estimated. The receiver operating characteristic analysis was then used to search for the optimal dose and volume cutoff points with the potential to distinguish patients with enhanced or escalated toxicity. RESULTS: Despite the application of high doses (78-82 Gy) in the IMRT group, GI toxicity was lower in that group than in the group treated by 3D-CRT with prescribed doses of 70 to 74 Gy. Both RT methods showed specific rectal dose-volume distribution curves. The total AUC values for IMRT were significantly lower than those for 3D-CRT. Furthermore, IMRT significantly decreased the rectal volume receiving low to intermediate radiation doses in comparison with 3D-CRT; specific cutoff limits predictable for the level of GI toxicity are presented and defined in our work. CONCLUSIONS: Total area under the dose-volume profiles and specific cutoff points in low and intermediate dose levels have significant predictive potential toward the RT GI toxicity. In treatment planning, it seems that it is valuable to take into consideration the entire dose-volume primary distribution.
- MeSH
- adenokarcinom patologie radioterapie MeSH
- celková dávka radioterapie MeSH
- gastrointestinální trakt účinky záření MeSH
- konformní radioterapie škodlivé účinky metody MeSH
- lidé MeSH
- nádory prostaty patologie radioterapie MeSH
- následné studie MeSH
- plánování radioterapie pomocí počítače metody MeSH
- plocha pod křivkou MeSH
- radiační poranění etiologie MeSH
- radioterapie s modulovanou intenzitou škodlivé účinky metody MeSH
- rektum účinky záření MeSH
- ROC křivka MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
BACKGROUND: To date, targeted temperature management (TTM) is the only neuroprotective intervention after resuscitation from cardiac arrest that is recommended by guidelines. The evidence on the effects of TTM is unclear. METHODS/DESIGN: The Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest (TTM2) trial is an international, multicentre, parallel group, investigator-initiated, randomised, superiority trial in which TTM with a target temperature of 33 °C after cardiac arrest will be compared with a strategy to maintain normothermia and active treatment of fever (≥ 37.8 °C). Prognosticators, outcome assessors, the steering group, the trial coordinating team, and trial statisticians will be blinded to treatment allocation. The primary outcome will be all-cause mortality at 180 days after randomisation. We estimate a 55% mortality in the targeted normothermia group. To detect an absolute risk reduction of 7.5% with an alpha of 0.05 and 90% power, 1900 participants will be enrolled. The secondary neurological outcome will be poor functional outcome (modified Rankin scale 4-6) at 180 days after cardiac arrest. In this paper, a detailed statistical analysis plan is presented, including a comprehensive description of the statistical analyses, handling of missing data, and assessments of underlying statistical assumptions. Final analyses will be conducted independently by two qualified statisticians following the present plan. DISCUSSION: This SAP, which was prepared before completion of enrolment, should increase the validity of the TTM trial by mitigation of analysis-bias.
- MeSH
- horečka MeSH
- hypotermie * MeSH
- kardiopulmonální resuscitace * MeSH
- lidé MeSH
- tělesná teplota MeSH
- terapeutická hypotermie * škodlivé účinky MeSH
- výsledek terapie MeSH
- zástava srdce mimo nemocnici * diagnóza terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
... 9 -- Introduction 9 -- The streptokinase meta-analysis 10 -- Statistical significance 11 -- Clinical ... ... use power analysis 262 -- Contents -- Planning for precision rather than for power 263 -- Power analysis ... ... in primary studies 263 -- Power analysis for meta-analysis 267 -- Power analysis for a test of homogeneity ... ... 355 -- 40 WHEN DOES IT MAKE SENSE TO PERFORM A META-ANALYSIS? ... ... 369 -- 42 CUMULATIVE META-ANALYSIS 371 -- Introduction 371 -- Why perform a cumulative meta-analysis ...
First published xxviii, 421 stran : ilustrace ; 25 cm
- MeSH
- metaanalýza jako téma * MeSH
- statistika jako téma MeSH
- Publikační typ
- metaanalýza MeSH
- příručky MeSH
- Konspekt
- Statistika
- NLK Obory
- statistika, zdravotnická statistika
... PLÁN STATISTICKÉHO SETŘENI -- III. SBĚR A ZÁZNAM STATISTICKÝCH ÚDAJÚ -- IV. ...
Acta facultatis medicae Universitatis Brunensis. Opuscula medicinae socialis ; 104
Vydání první 1 svazkek : ilustrace, tabulky ; 25 cm
Kniha podává stručný výklad statistických metod a postupů. Tyto spojuje s myšlením lékaře ve výzkumu a ve zdravotnické praxi. Text je určen odborné veřejnosti. Poukazuje na význam kvantitativního myšlení a statistického hodnocení v lékařském výzkumu. Chce zvýšit zájem o statistickou metodologi a být východiskem dalších studií.
- MeSH
- biomedicínský výzkum metody MeSH
- statistika jako téma MeSH
- výzkum MeSH
- Publikační typ
- sborníky MeSH
- MeSH
- algoritmy MeSH
- antropologie statistika a číselné údaje MeSH
- etika výzkumu MeSH
- interpretace statistických dat MeSH
- lidé MeSH
- pohyb MeSH
- statistika jako téma MeSH
- systémová analýza MeSH
- tělesná výchova statistika a číselné údaje MeSH
- výzkum normy trendy MeSH
- výzkumný projekt MeSH
- Check Tag
- lidé MeSH
- MeSH
- socialismus MeSH
- statistika jako téma MeSH
- veřejné zdravotnictví MeSH
- zdravotničtí pracovníci MeSH
- Geografické názvy
- Československo MeSH
