Table 1 Reporting recommendations for evaluations of risk prediction models that include genetic variants

From: Strengthening the reporting of genetic risk prediction studies (GRIPS): explanation and elaboration

Title and abstract

  
 

1

(a) Identify the article as a study of risk prediction using genetic factors. (b) Use recommended keywords in the abstract: genetic or genomic, risk, prediction.

Introduction

 Background and rationale

2

Explain the scientific background and rationale for the prediction study.

 Objectives

3

Specify the study objectives and state the specific model(s) that is/are investigated. State if the study concerns the development of the model(s), a validation effort, or both.

Methods

 Study design and setting

4

Specify the key elements of the study design and describe the setting, locations and relevant dates, including periods of recruitment, follow-up and data collection.a

 Participants

5

Describe eligibility criteria for participants, and sources and methods of selection of participants.a

 Variables: definition

6

Clearly define all participant characteristics, risk factors and outcomes. Clearly define genetic variants using a widely-used nomenclature system.a

 Variables: assessment

7

(a) Describe sources of data and details of methods of assessment (measurement) for each variable. (b) Give a detailed description of genotyping and other laboratory methods.a

 Variables: coding

8

(a) Describe how genetic variants were handled in the analyses. (b) Explain how other quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen, and why.

 Analysis: risk model construction

9

Specify the procedure and data used for the derivation of the risk model. Specify which candidate variables were initially examined or considered for inclusion in models. Include details of any variable selection procedures and other model-building issues. Specify the horizon of risk prediction (eg, 5-year risk).

 Analysis: validation

10

Specify the procedure and data used for the validation of the risk model.

 Analysis: missing data

11

Specify how missing data were handled.

 Analysis: statistical methods

12

Specify all measures used for the evaluation of the risk model including, but not limited to, measures of model fit and predictive ability.

 Analysis: other

13

Describe all subgroups, interactions and exploratory analyses that were examined.

Results

 Participants

14

Report the numbers of individuals at each stage of the study. Give reasons for non-participation at each stage. Report the number of participants not genotyped, and reasons why they were not genotyped.a

 Descriptives: population

15

Report demographic and clinical characteristics of the study population, including risk factors used in the risk modeling.a

 Descriptives: model estimates

16

Report unadjusted associations between the variables in the risk model(s) and the outcome. Report adjusted estimates and their precision from the full risk model(s) for each variable.

 Risk distributions

17

Report distributions of predicted risks and/or risk scores.a

 Assessment

18

Report measures of model fit and predictive ability, and any other performance measures, if pertinent.

 Validation

19

Report any validation of the risk model(s).

 Other analyses

20

Present results of any subgroup, interaction or exploratory analyses, whenever pertinent.

Discussion

 Limitations

21

Discuss limitations and assumptions of the study, particularly those concerning study design, selection of participants, measurements and analyses and discuss their impact on the results of the study.

 Interpretation

22

Give an overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies, and other relevant evidence.

 Generalizability

23

Discuss the generalizability and, if pertinent, the health care relevance of the study results.

Other

 Supplementary information

24

State whether databases for the analyzed data, risk models and/or protocols are or will become publicly available and if so, how they can be accessed.

 Funding

25

Give the source of funding and the role of the funders for the present study. State whether there are any conflicts of interest.

  1. aMarked items should be reported for every population in the study.