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Table 3 Risk of bias of included studies (RCTs)

From: The effectiveness of couple-based interventions on the marital outcomes of women with genital and breast cancer and their partners: a systematic review and meta-analysis

Bias

Authors’ judgment

Support for judgment

Baucom et al. (2008)

  

Random sequence generation

Low risk

Participants were allocated into interventions and control groups, using a computer-based random number generator.

Allocation concealment

Unclear risk

Allocation in the groups was done by an employee, but nothing was mentioned about the employee being blind.

Blinding of participants and personnel

Low risk

Blinding

Blinding of outcome assessors

Low risk

Blinding

Incomplete outcome data

Unclear risk

There is not enough information about incomplete data.

Selective reporting

Low risk

Protocol is not available but it is clear that all pre-specified and expected outcomes of interest are reported.

Budin et. (2008)

  

Random sequence generation

Low risk

Participants were allocated into intervention and control groups, using the block randomization method.

Allocation concealment

High risk

There is not enough information in this regard.

Blinding of participants and personnel

High risk

Open-label design

Blinding of outcome assessors

High risk

Open-label design

Incomplete outcome data

Low risk

21 of 66 patients in intervention group one 24 of 66 patients in intervention group two and 18 of 58 patients in the intervention group three and 9 of 59 patients in the control group were excluded. 32 of 66 partners in intervention group one 36 of 66 partners in intervention group two and 29 of 58 partners in the intervention group three and 26 of 59 partners in the control group were excluded. Reasons for missing data were that interventions were not completed within the specified time frame, patients or partners did not return completed questionnaires, and patients or partners decided to withdraw.

Selective reporting

Low risk

Protocol is not available but pre-specified outcomes of interest to the review are reported in a pre-specified way.

Christensen (1983)

  

Random sequence generation

Unclear risk

It is mentioned in the text that the groups are allocated randomly, but the authors did not provide enough information in this regard.

Allocation concealment

High risk

There is not enough evidence in this regard.

Blinding of participants and personnel

High risk

Open-label design

Blinding of outcome assessors

High risk

Open-label design

Incomplete outcome data

Unclear risk

There is not enough information about incomplete data.

Selective reporting

Low risk

Protocol is not available but it is clear that all pre-specified and expected outcomes of interest are reported.

Fergus et al. (2022)

  

Random sequence generation

Low risk

Participants were allocated into interventions and control groups, using a randomized block design.

Allocation concealment

High risk

There is not enough evidence in this regard.

Blinding of participants and personnel

High risk

Open-label design

Blinding of outcome assessors

High risk

Open-label design

Incomplete outcome data

Low risk

Eight of 39 participants in the intervention group were excluded which reasons for missing data are not related to outcomes.

Selective reporting

Low risk

Protocol is not available but all pre-specified outcomes of interest to the review are reported in the pre-specified way.

Kalaitz et al. (2007)

  

Random sequence generation

Unclear risk

It is mentioned in the text that the groups are allocated randomly, but the authors did not provide enough information in this regard.

Allocation concealment

High risk

There is not enough evidence in this regard.

Blinding of participants and personnel

High risk

Open-label design

Blinding of outcome assessors

High risk

Open-label design

Incomplete outcome data

Unclear risk

There is not enough information about incomplete data.

Selective reporting

Low risk

Protocol is not available but it is clear that all pre-specified and expected outcomes of interest are reported.

Li et al. (2023)

  

Random sequence generation

Low risk

Participants were allocated into interventions and control groups, using a computer random number generator.

Allocation concealment

Low risk

Allocation concealment was done by sequentially numbered, opaque, sealed envelopes.

Blinding of participants and personnel

High risk

No blinding

Blinding of outcome assessors

High risk

No blinding

Incomplete outcome data

Low risk

14 of 49 participants in the intervention group and 12 of 49 participants in the control group dropped out of the study but reasons for missing data were not related to outcome.

Selective reporting

Low risk

Protocol is available and all pre-specified outcomes of interest to the review are reported in the pre-specified way.

Nicolaisen et al. (2018)

  

Random sequence generation

Low risk

Participants were allocated into interventions and control groups, using the computer-based randomization and block randomization methods.

Allocation concealment

Low risk

Block size and allocation sequence were performed by independent statisticians.

Blinding of participants and personnel

High risk

Participants were not blinded

Blinding of outcome assessors

Low risk

Blinding

Incomplete outcome data

Low risk

22 of 102 participants in the intervention group and 35 of 96 participants in the control group dropped out of the study but reasons for missing data were not related to outcome.

Selective reporting

High risk

Protocol is available but all pre-specified outcomes of interest to the review are not reported in the pre-specified way.

Price-Blackshear et al. (2020)

  

Random sequence generation

Unclear risk

It is mentioned in the text that the groups are allocated randomly, but the authors did not provide enough information in this regard.

Allocation concealment

High risk

There was no evidence for allocation concealment.

Blinding of participants and personnel

High risk

Open-label design

Blinding of outcome assessors

High risk

Open-label design

Incomplete outcome data

Low risk

25 of 61 participants in the intervention group and 16 of 57 participants in the control group dropped out of the study. Missing data were not balanced across groups, but the reasons were similar (watched less than 4 videos, too sick, had baby, partner stopped participating, too much time).

Selective reporting

Low risk

Protocol is not available but it is clear that all pre-specified and expected outcomes of interest are reported.

Reese et al. (2018)

  

Random sequence generation

Low risk

Participants were allocated into interventions and control groups, using the stratified and block method

Allocation concealment

High risk

Study project manager assigned participants to interventions but nothing was mentioned about being blind.

Blinding of participants and personnel

High risk

Open-label design

Blinding of outcome assessors

High risk

There is not enough evidence in this regard.

Incomplete outcome data

Low risk

One of 20 participants in the intervention group was excluded which reasons for missing data are not related to outcomes.

Selective reporting

Low risk

Protocol is not available but all pre-specified outcomes of interest to the review are reported in the pre-specified way.

Zhang et al. (2022)

  

Random sequence generation

Low risk

Participants were allocated into interventions and control groups, using a computer random number generator.

Allocation concealment

Low risk

Allocation concealment was done by opaque sealed envelopes with group allocation codes

Blinding of participants and personnel

High risk

No blinding

Blinding of outcome assessors

Low risk

Blinding

Incomplete outcome data

Low risk

Five of 51 participants in the intervention and four of 53 participants in the control group were excluded. The reasons for missing data were the 3-month follow-up period due to withdrawal of consent and loss of follow-up

Selective reporting

Low risk

Protocol is not available but all pre-specified outcomes of interest to the review are reported in the pre-specified way.