Review title or ID

Study ID(surname of first author and year first full report of study was published e.g. Smith 2001)

Report IDs of other reports of this study(e.g. duplicate publications, follow‐up studies)

Notes:

Date form completed(dd/mm/yyyy)

Name/ID of person extracting data

Report title

(title of paper/ abstract/ report that data are extracted from)

Report ID

(ID for this paper/ abstract/ report)

Reference details

Report author contact details

Publication type

(e.g. full report, abstract, letter)

Study funding sources

(including role of funders)

Possible conflicts of interest

(for study authors)

Notes:

Study Characteristics

Eligibility criteria

(Insert eligibility criteria for each characteristic as defined in the Protocol)

Yes

No

Unclear

Location in text

(pg & ¶/fig/table)

Type of study

Randomized controlled trial

Participants

Types of intervention

Types of outcome measures

INCLUDE

EXCLUDE

Reason for exclusion

Notes:

Description

Include comparative information for each group (i.e. intervention and controls) if available

Location in text

(pg & ¶/fig/table)

Population description

(from which study participants are drawn)

Setting

(including location and social context)

Inclusion criteria

Exclusion criteria

Method/s of recruitment of participants

Informed consent obtained

Yes No Unclear

Notes:

Descriptions as stated in report/paper

Location in text

(pg & ¶/fig/table)

Aim of study

Design(e.g. parallel, crossover, cluster)

Unit of allocation

(by individuals, cluster/ groups or body parts)

Start date

End date

Total study duration

Ethical approval needed/ obtained for study

Yes No Unclear

Notes:

Domain

Risk of bias

Support for judgement

Location in text

(pg & ¶/fig/table)

Random sequence generation

(selection bias)

Allocation concealment

(selection bias)

Blinding of participants and personnel

(performance bias)

Outcome group: All/

(if required)

Outcome group:

Blinding of outcome assessment

(detection bias)

Outcome group: All/

(if required)

Outcome group:

Incomplete outcome data

(attrition bias)

Selective outcome reporting?

(reporting bias)

Other bias

Notes:

Description as stated in report/paper

Location in text

(pg & ¶/fig/table)

Total no. randomized

(or total pop. at start of study for NRCTs)

Clusters

(if applicable, no., type, no. people per cluster)

Baseline imbalances

Withdrawals and exclusions

(if not provided below by outcome)

Age

Sex

Race/Ethnicity

Severity of illness

Co‐morbidities

Other treatment received(additional to study intervention)

Other relevant sociodemographics

Subgroups measured

Subgroups reported

Notes:

Description as stated in report/paper

Location in text

(pg & ¶/fig/table)

Group name

No. randomized to group

(specify whether no. people or clusters)

Theoretical basis(include key references)

Description(include sufficient detail for replication, e.g. content, dose, components)

Duration of treatment period

Timing(e.g. frequency, duration of each episode)

Delivery(e.g. mechanism, medium, intensity, fidelity)

Providers

(e.g. no., profession, training, ethnicity etc. if relevant)

Co‐interventions

Economic variables
(i.e. intervention cost, changes in other costs as result of intervention)

Resource requirements to replicate intervention

(e.g. staff numbers, cold chain, equipment)

Notes:

Description as stated in report/paper

Location in text

(pg & ¶/fig/table)

Outcome name

Time points measured

Time points reported

Outcome definition(with diagnostic criteria if relevant)

Person measuring/reporting

Unit of measurement

(if relevant)

Scales: upper and lower limits(indicate whether high or low score is good)

Is outcome/tool validated?

Yes No Unclear

Imputation of missing data
(e.g. assumptions made for ITT analysis)

Assumed risk estimate

(e.g. baseline or population risk noted in Background)

Power

Notes:

Description as stated in report/paper

Location in text

(pg & ¶/fig/table)

Comparison

Outcome

Subgroup

Timepoint
(specify whether from start or end of intervention)

Results

Intervention

Comparison

No. events

No. participants

No. events

No. participants

No. missing participants and reasons

No. participants moved from other group and reasons

Any other results reported

Unit of analysis(by individuals, cluster/groups or body parts)

Statistical methods used and appropriateness of these methods(e.g. adjustment for correlation)

Reanalysis required?(specify)

Yes No Unclear

Reanalysis possible?

Yes No Unclear

Reanalysed results

Notes:

Description as stated in report/paper

Location in text

(pg & ¶/fig/table)

Comparison

Outcome

Subgroup

Timepoint
(specify whether from start or end of intervention)

Post‐intervention or change from baseline?

Results

Intervention

Comparison

Mean

SD (or other variance)

No. participants

Mean

SD (or other variance)

No. participants

No. missing participants and reasons

No. participants moved from other group and reasons

Any other results reported

Unit of analysis

(individuals, cluster/ groups or body parts)

Statistical methods used and appropriateness of these methods(e.g. adjustment for correlation)

Reanalysis required?(specify)

Yes No Unclear

Reanalysis possible?

Yes No Unclear

Reanalysed results

Notes:

Description as stated in report/paper

Location in text

(pg & ¶/fig/table)

Comparison

Outcome

Subgroup

Timepoint
(specify whether from start or end of intervention)

Results

Intervention result

SD (or other variance)

Control result

SD (or other variance)

Overall results

SE (or other variance)

No. participants

Intervention

Control

No. missing participants and reasons

No. participants moved from other group and reasons

Any other results reported

Unit of analysis(by individuals, cluster/groups or body parts)

Statistical methods used and appropriateness of these methods

Reanalysis required?(specify)

Yes No Unclear

Reanalysis possible?

Yes No Unclear

Reanalysed results

Notes:

Have important populations been excluded from the study?(consider disadvantaged populations, and possible differences in the intervention effect)

Yes No Unclear

Is the intervention likely to be aimed at disadvantaged groups?(e.g. lower socioeconomic groups)

Yes No Unclear

Does the study directly address the review question?

(any issues of partial or indirect applicability)

Yes No Unclear

Notes:

Description as stated in report/paper

Location in text

(pg & ¶/fig/table)

Key conclusions of study authors

References to other relevant studies

Correspondence required for further study information(from whom, what and when)

Notes: