# Data package specification

# Version 1

The data package consists of a zipped folder with CD number, code or Review ID as identifier.

Three subfolders may be included if content exists in the review:

- Analysis data
- Study data
- Other references

Each subfolder can include the following files:

## Analysis data

### Important notes

- The setting "Log scale data" indicates whether the data were analyzed on a log scale. For example, for an odds ratio (effect measure) analysis, the statistical pooling is done on the log-odds ratio scale, so "log-scale data" is set as TRUE. In this example, the "GIV Mean" and "GIV SE" columns would correspond to the log-odds ratio. However the study-level and pooled estimates and their confidence intervals (columns Mean, CI start, CI end) correspond to the values displayed on the forest plots, and would therefore be odds ratios, and not log-odds ratios.

### Overall estimates and settings

Analysis group | Analysis number | Analysis name | Analysis group name | Data source | Data source eligibility | Data type | Log-scale data | Outcome | Intervention grouping | Experimental intervention | Control intervention | Subgroup by | Filter criteria | Experimental group label | Control group label | Statistical method | Effect measure | Unit of effect measure | Analysis model | Subgroup estimates | Overall estimates | Test for subgroup differences | Swap event and non-event | Study CI | Estimate CI | Experimental cases | Experimental N | Control cases | Control N | Mean | CI start | CI end | Heterogeneity Tau² | Heterogeneity Chi² | Heterogeneity df | Heterogeneity P | Heterogeneity I² | Effect Z | Effect P | Subgroup Chi² | Subgroup df | Subgroup P | Subgroup I² | Analysis ID |

Identifying information | "Study data" or "Custom input" | TBC possible values for this field. Only for "Study data" analyses | "Contrast level" or "Arm level" | TRUE if data were analyzed on log scale | Synthesis PICO settings for study-centric analyses (data source = "Study data"). | Graph labels. | Statistical settings for the analysis. | Totals of all studies included in the analysis. May be missing. | Pooled estimate. NOT on the log scale even if "log-scale data" is true. | Overall heterogeneity statistics. | Test for overall effect. | Test for subgroup differences. | RevMan internal ID of the analysis. May be useful to disambiguate imports of multiple versions of the same dataset. |

### Analysis data rows

Analysis group | Analysis number | Analysis name | Subgroup | Study | Study year | GIV Mean | GIV SE | Experimental mean | Experimental SD | Experimental cases | Experimental N | Control mean | Control SD | Control cases | Control N | O-E | Variance | Weight | Mean | CI start | CI end | Footnotes | Bias arising from the randomization process (judgement) | Bias arising from the randomization process (support) | Bias due to deviations from intended interventions (judgement) | Bias due to deviations from intended interventions (support) | Bias due to missing outcome data (judgement) | Bias due to missing outcome data (support) | Bias in measurement of the outcome (judgement) | Bias in measurement of the outcome (support) | Bias in selection of the reported result (judgement) | Bias in selection of the reported result (support) | Overall bias (judgement) | Overall bias (support) |

Identifying information | Name of a subgroup or empty if the data row is not in a subgroup | Name of a study | Year study conducted | Fields for GIV data rows (i.e. contrast data) | Fields for continuous data rows. | Field for dichotomous data rows. | Sample size. | Fields for continuous data rows. | Field for dichotomous data rows. | Sample size. | Fields for O-E and variance data rows. | Weight the study has been given in the overall analysis. | Effect estimate for this data row. NOT on the log scale even if "log-scale data" is true. | Footnotes (text) for this data row. | Risk of bias information for this data row (TBC: when are these present, and when can they vary?) |

### Subgroup estimates

Analysis group | Analysis number | Subgroup | Subgroup number | Experimental cases | Experimental N | Control cases | Control N | Weight | Mean | CI start | CI end | Heterogeneity Tau² | Heterogeneity C hi² | Heterogeneity df | Heterogeneity P | Heterogeneity I² | Effect Z | Effect P |

Identifying information | Name of a subgroup | Subgroup number (order) | Totals of all studies included in the subgroup. May be missing. | Share of the overall weight of studies included in this subgroup. | Pooled estimate within this subgroup. NOT on the log scale even if "log-scale data" is true. | Within-subgroup heterogeneity statistics. | Test for within-subgroup effect. |

### Parameters (Diagnostic Test Accuracy reviews)

Analysis number | Analysis name | Test number | Test name | Subgroup by | Subgroup item | Subgroup | Model | Lambda | Theta | beta | Var(accuracy) | Var(threshold) | E(logitSe) | E(logitSp) | Var(logitSe) | Var(logitSp) | Cov(logits) | Corr(logits) | SE(E(logitSe)) | SE(E(logitSp)) | Cov(Es) | Studies | Summary point | Summary curve | Confidence reg | Conf reg level | Prediction reg | Pred reg level |

### Data rows (Diagnostic Test Accuracy reviews)

Analysis number | Analysis name | Test number | Test name | Subgroup by | Subgroup item | Subgroup | Study | TP | FP | FN | TN | Sensitivity | Sens CI start | Sens CI end | Specificity | Spec CI start | Spec CI end |

## Study data

### Study information

Study | Year | Data source | ID: DOI | Char: Methods | Char: Participants | Char: Interventions | Char: Outcomes | Char: Notes | Cov: Disease severity | Cov: Treatment duration |

The "Study ID" | The year of the study (e.g. "2022" or "2022b"). | The data source: PUB = published data only (unpublished not sought), MIX = Published and unpublished data, UNPUB = unpublished data only, SOUGHT = Published data only (unpublished sought but not used) | Columns with heading "ID: <type>" represents study identifiers in RevMan. Available types: DOI, ISCRCTN, clinicalTrials.gov, Other. | A column with heading "Char: <name>" represents the study characteristic of the given name in RevMan. | A column with heading "Cov: <name>" will repressent the covariate of the given name in RevMan. |

### Study arms

Study | Arm | Description | Intervention |

The "Study ID" as (or to be) entered in RevMan. | The name of the arm. | Arm description. | Intervention administered in the arm. |

### Study results

Arm | Reference arm | Sample size | Cases | Mean | SD | SE | Variance | CI level | CI start | CI end | Exp mean | Exp CI start | Exp CI end | t-test | z-test | P value | Covariance method | Covariance | Other arm 1 | Other arm 2 | Correlation arm 1 | Correlation arm 2 | Correlation | Other mean | Other SE | Other variance | Other CI level | Other CI start | Other CI end | Other exp mean | Other exp CI start | Other exp CI end | Other t-test | Other z-test | Other P value |

The arm that data is recorded for. | Whether the given arm is the reference arm for the contrasts: true or false. Contrast level results only. | Number of participants in the given arm. | Number of cases (out of the total number of participants). Labeled "events" in RevMan. Arm-level results for dichotomous outcomes only. | Mean effect size in the given arm. Arm-level results for continuous outcomes and contrast-level results. | Standard deviation of the effect size in the given arm. Arm-level results for continuous outcomes only. | Standard error of the effect size in the given arm. Arm-level results for continuous outcomes and contrast-level results. | Variance of the effect size in the given arm. Arm-level results for continuous outcomes and contrast-level results. | CI level: the confidence level (0.90, 0.95, 0.99) at which the CI or Exp CI are specified. Arm-level results for continuous outcomes and contrast-level results. | Confidence interval of the effect size in the given arm. CI start and end are the bounds of the interval. Arm-level results for continuous outcomes and contrast-level results. | The anti-logged mean (e.g. the odds ratio if the effect measure is the log-odds ratio). Contrast-level results with a log-scale effect measure only. | The confidence interval of the anti-logged effect measure (e.g. the odds ratio for the log-odds ratio). Contrast level results with a log-scale effect measure only. | Student-T test statistic for the effect size excluding 0. Arm-level results for continuous outcomes only. | Normal (Z) test statistic for the effect size excluding 0. Contrast-level results only. | P-value for the null hypothesis that the effect size is 0. Arm-level results for continuous outcomes and contrast-level results. | Method of calculating the covariance between contrasts (only relevant if the study has 3+ arms). "Specify", "Approximation", "Data on another contrast", or "Data on correlation". Reference arm of contrast-level results only. | Enter Covariance directly. Covariance method = "Specify" only. | The covariance will be calculated based on data for three contrasts: (Arm 1 vs Reference), (Arm 2 vs Reference), and (Arm 2 vs Arm 1). The effect size for (Arm 2 vs Arm 1) is calculated from the following columns. Covariance method = "Data on another contrast" only. | The covariance was calculated based on the given correlation between the contrasts: (Arm 1 vs Reference) and (Arm 2 vs Reference). Covariance method = "Data on correlation" only. | See the corresponding column without "Other ". |

### Risk of bias 1

Study | Domain (judgement): Random sequence generation (selection bias) | Domain (support): Random sequence generation (selection bias) | Domain (judgement): Allocation concealment (selection bias) | Domain (support): Allocation concealment (selection bias) | Domain (judgement): Blinding of participants and personnel (performance bias) All outcomes | Domain (support): Blinding of participants and personnel (performance bias): All outcomes | Domain (judgement): Blinding of outcome assessment (detection bias): Objective outcomes | Domain (support): Blinding of outcome assessment (detection bias): Objective outcomes | Domain (judgement): Blinding of outcome assessment (detection bias): Subjective outcomes | Domain (support): Blinding of outcome assessment (detection bias): Subjective outcomes | Domain (judgement): Incomplete outcome data (attrition bias): All outcomes | Domain (support): Incomplete outcome data (attrition bias): All outcomes | Domain (judgement): Selective reporting (reporting bias) | Domain (support): Selective reporting (reporting bias) | Domain (judgement): Other bias | Domain (support): Other bias |

The "Study ID" as (or to be) entered in RevMan. Mandatory. | A column with heading "Domain (judgement): <name>: " represents the domain judgement of the given name in RevMan. A column with heading "Domain (support): <name>: " will set the domain support for judgement of the given name in RevMan. For outcome domains, "All outcomes" in column name after the domain name e.g. "Domain (judgement): <name>: All outcomes" indicates the judgement for all outcomes (no outcome grouping). For outcome domains, "<group name>" in column name after the domain name e.g. "Domain (judgement): <name>: <group name>" indicates the judgement for the outcome group <outcome name>. Risk of bias judgement as "High risk", "Unclear risk", or "Low risk" for each row. |

### Study data (JSON)

https://assets.cochrane.org/schema/v1/studies.schema.json

https://assets.cochrane.org/schema/v1/review-level-concepts.schema.json

https://assets.cochrane.org/schema/v1/study.schema.json

https://assets.cochrane.org/schema/v1/contrast-raw-data.schema.json

https://assets.cochrane.org/schema/v1/continuous-raw-data.schema.json

https://assets.cochrane.org/schema/v1/covariance.schema.json

https://assets.cochrane.org/schema/v1/risk-of-bias-judgements.schema.json

### Study test data - Diagnostic Test Accuracy reviews only

Study | Year | Test number | Test | TP | FP | FN | TN | Cov: <name> |

## References

Identifier tags relevant for all reference types:

Study ID/study name | NS |

DOI | DO |

Any other identifier (including CRS) | C3 |

### Tags supported for each reference type

#### Journal article

Reference type | TY - JOUR |

Authors | AU (1 tag for each author) |

English title | TI |

Original title | TT |

Journal/Book/Source | JF |

Date of publication | DA |

Volume | VL |

Issue | IS |

Pages | SP & EP (If only one value exists, SP) |

#### Book

Reference type | TY - BOOK |

Authors | AU (1 tag for each author) |

Journal/Book/Source | BT |

Date of publication | DA |

Volume | VL |

Edition | ET |

Publisher name/Publisher | PB |

City of publication | CY |

#### Book chapter

Reference type | TY - CHAP |

Authors | AU (1 tag for each author) |

English title | TI |

Original title | TT |

Journal/Book/Source | JF |

Date of publication | DA |

Volume | VL |

Pages | SP & EP (If only one value exists, SP) |

Edition | ET |

Editor(s) | ED |

Publisher name/Publisher | PB |

City of publication | CY |

#### Conference proceedings

Reference type | TY - CPAPER |

Authors | AU (1 tag for each author) |

English title | TI |

Original title | TT |

Journal/Book/Source | JF |

Date of publication | DA |

Volume | VL |

Pages | SP & EP (If only one value exists, SP) |

Edition | ET |

Editor(s) | ED |

Publisher name/Publisher | PB |

City of publication | CY |

#### Other

Reference type | TY - GEN |

Authors | AU (1 tag for each author) |

English title | TI |

Original title | TT |

Journal/Book/Source | JF |

Date of publication | DA |

Volume | VL |

Issue | IS |

Pages | SP & EP (If only one value exists, SP) |

#### Correspondence

Reference type | TY - PCOMM |

Authors | AU (1 tag for each author) |

English title | CT |

Original title | TT |

Journal/Book/Source | JF |

Date of publication | DA |

#### Unpublished data

Reference type | TY - UNPB |

Authors | AU (1 tag for each author) |

English title | CT |

Original title | TT |

Journal/Book/Source | JO |

Date of publication | DA |

#### Computer program

Reference type | TY - COMP |

Authors | AU (1 tag for each author) |

English title | TI |

Original title | TT |

Date of publication | DA |

Edition | ET |

Publisher name/Publisher | PB |

City of publication | CY |

Medium | MD |

#### Cochrane review

Reference type | TY - JOUR |

Authors | AU (1 tag for each author) |

English title | TI |

Original title | TT |

Journal/Book/Source | JF |

Date of publication | DA |

Issue | IS |

#### Cochrane protocol

Reference type | TY - JOUR |

Authors | AU (1 tag for each author) |

English title | TI |

Original title | TT |

Journal/Book/Source | JF |

Date of publication | DA |

Issue | IS |