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NICOR STATISTICAL ANALYSIS PROTOCOL
CONTENTS CHECKLIST: V1 APRIL 2014
While not all the categories below will be relevant to all applications, an application will be returned to
the applicant if a relevant section has not been included. Where possible, NICOR will assist and
provide advice. NICOR would advise, that the SAP is based on current STROBE guidelines, where
appropriate (http://www.strobestatement.org/fileadmin/Strobe/uploads/checklists/STROBE_checklist_v4_combined.pdf)
Yes
Title and abstract
Governance/approvals/permissions
 Research ethics approval or letter from Research and Development that ethics
not required
 Proof of Confidentiality Advisory Group approval/patient consent obtained
 Other approvals/reference numbers (e.g. ISAC; clinicaltrial.gov)
Background/Rationale for proposal
Objective(s)
Study design
 General study design type
 Setting (for example, relevant dates, follow-up)
 Target population (inclusion and exclusion criteria; refer to STROBE statement
for different study designs)
 Randomisation/blinding (if a clinical trial)
 Linkage methods
o What linkage (NICOR datasets/external data sources)
o Who will do linkage
o Data flow diagram
 Sample size calculation

Study variables (Clearly define all outcomes, exposures, predictors, potential
confounders, effect modifiers and derived variables. Give diagnostic criteria, if
applicable)

Derived variables

Details of other sources of data required/applied for, for this project
Statistical methods
 Statistical analysis techniques (e.g. logistic, survival regression; refer to
STROBE guidelines for different study designs)
 Strategy for included multiple variables (e.g model selection choice)
 Strategy for dealing with missing data (e.g. complete case analysis vs multiple
imputation; refer to STROBE guidelines for different study designs)
 Describe any sensitivity analyses
 Strategy for handling continuous variables (e.g. variable transformation,
threshold levels, modeling non-linear trends)
 Sub-group analysis plan
 Measures to assess model performance (e.g. internal validation; external
validation criteria)
Results (how results will be presented; refer to STROBE guidelines)
 Participants

Descriptive data

Outcome data
 Main results (including effect estimates (e.g. odds ratios, hazard ratios) and
confidence intervals))
 Other analyses
Discussion: Limitations of the study
Dissemination
 Target journal
 Patient and public dissemination strategy
No
NA