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. 2023 Oct 24;2023(10):CD014722. doi: 10.1002/14651858.CD014722.pub2

Risk of bias for analysis 8.2 Depressive symptoms at 0‐1 months—indicated prevention adults.

Study Bias
Randomisation process Deviations from intended interventions Missing outcome data Measurement of the outcome Selection of the reported results Overall
Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement
Chew 2018 Low risk of bias 1a.1: Y; 1a.2: PY. Note: Title mentions RCT design. 
Quote: "In assigning the HCs to the VEMOFIT group (VG) or attention‐control groups (AG), randomisation will be carried out after stratification by cluster size and geographical areas of the 10 HCs."
Quote: "A member of the Data Management Services team at the University Medical center, Ultrecht will carry out the randomisation."
1.3: NI. Note: No useful information is reported to evaluate this element
1b.1: PY. Seems that participants were recruited after randomization.		 Low risk of bias 2.1a: PY. 2.1b: PN. Quote: "We use a modified informed consent procedure to ensure that patients are unware of the two different intervention programmes".
2.2.: Y. Nurses were trained to deliver the intervention.
2.3: PN. Note: No evidence to suggest deviations from the intended intervention that arose because of the trial context.
2.4: NA.
2.5: NA.
2.6: Y. Note: The analysis was carried out on an intention to treat basis.
2.7: NA.		 Low risk of bias 3.1a: PY. All 10 clusters that recruited participants were analyzed. 
3.1b: PN. 92 from intervention group (n = 145) and 79 from control group (n = 150) did not receive allocated intervention. In addition to the 33 people lost to follow up at 12 months, 5 additional missing data were noted with regard to PHQ‐9.
3.2: PN. No evidence that the result was not biased by missing data.
3.3: PN; 3.4: NA. Note: Missingness in the outcome do not depend on its true value.		 Low risk of bias 4.1: N. Note: The selected outcome method (Malay Brief Illness Perception Quetsionnaire, MBIPQ) is validated and established.
4.2: PN. Note: No evidence to suggest differences in measurement between intervention and control
4.3a: PY.Outcome assessors (participants) were most likeley aware that a trial was taking a place.
4.3b: PN. Quote: "We use a modified informed consent procedure to ensure that patients are unware of the two different intervention programmes"
4.4: NA.
4.5: NA.		 Low risk of bias 5.1: PY. Note: Protocol is available.
5.2: PN. Note: No evidence to suggest outcome selection. Almost all outcomes mentioned in the methods and protocol were reported (It is not reported "heath‐care utilization hospital" that is a secondary outcome).
5.3: PN. Note: No evidence to suggest analyses selection. All outcomes mentioned in the methdis and protocol were reported.		 Low risk of bias The study is judged to be at low risk of bias for all domains.
Sangraula 2020 Low risk of bias 1a.1: PY. 1a.2: PY. Quote: "A randomization procedure was used, in which names of the two VDCs were written on cards and placed into a hat. The District Public Health Officer (DPHO) was to draw one card from the hat which would be allocated as the intervention arm VDC and the VDC in the remaining card would be allocated to the control arm. Program staff, including community psychosocial workers (CPSWs) and research assistants (RAs) were only assigned to either VDC after the random drawing to reduce risk of unblinding.
1a.3: PN. There is no evidencde to suggest problems in the randomization process
1b.1: PN. it appears the randomization was conducted prior to the recruitment of participants.
1b.2: PN. It is unlikely that the selection of inidividual participants was affected by knowledge of the intervention assigned to the cluster.
1b.3: PN. there is no evidence to indicate imbalances in baseline values to indicate differentail identification or recruitment of individual participants.		 Low risk of bias 2.1 a:NI. 2.1b: PN. 2.2: PN. Quote: "CPSWs, RAs, trial participants, and local mhGAP trained health workers were blinded to the allocation of the study conditions. The VDCs of the two arms were separated by another VDC which worked as a buffer and physical barrier against contamination between the two arms. CPSWs in both arms were instructed not to disclose the treatment that any participants received except with their clinical supervisors. The trial statistician was blinded to treatment arm during analysis. "
2.3: NA.
2.4: NA.
2.5: NA.
2.6: PY. Data was analysed for most participants randomized.		 Low risk of bias 3.1a: Y. all included clusters were analyzed;
3.1b: PY. data were available for nearly all participants within the cluster
3.2: NA.
3.3: NA.
3.4: NA.		 Low risk of bias 4.1: PN. The outcome measure (PHQ‐9) is widely established and used across contexts, included the one of the trial
4.2: PN. No evidence to suggest that measurement or ascertainment of the outcome differed between intervention groups.
4.3a:NI. 4.3b: PN. No information provided on whether participants knew that they were in a trial, participants (outcome assessors) were blinded		 Low risk of bias 5.1: PY. No evidence to suggest otherwise, protocol and paper do not show discrepancies.
5.2: PN. No evidence to suggest outcome selection. All outcomes mentioned in the protocol, methods and results were reported.
5.3: PN. No evidence to suggest analyses selection. All analyses mentioned in the protocol, methods and results were reported.		 Low risk of bias The study is judged to be at low risk of bias for all domains.