Risk of bias for analysis 1.1 Repetition of SH at post‐intervention.
| 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 | |
| Mousavi 2017 | Some concerns | "Eligible subjects were allocated to two groups (intervention and control), with simple randomization by a third party physician using tables of random numbers" (p.2). No information on allocation concealment reported. "There is no difference between the two groups in terms of demographic and clinical characteristics" (p.3). |
Some concerns | Given the difference in therapeutic intensity between the intervention and comparator arms, it is unlikely that participant and clinical personnel blinding could have been convincingly achieved. There were no apparent deviations from the intended intervention. There was no information as to whether intention‐to‐treat analyses had been conducted. Subsequent analyses appear to be based on those participants with available information suggesting modified intention to treat analyses were used. |
Low risk of bias | Data were available for 100% of those randomised. | Some concerns | Data on repetition of self‐harm was obtained via self‐report. However, previous work has demonstrated that self‐harm prevalence estimates derived from self‐report may be underestimated, and supplementing prevalence estimates with medical or clinical record information is advisable (Mars 2016). As both the intervention and comparator arms received face‐to‐face therapy in this trial, there was no significant difference in treatment modality. Given the difference in therapeutic intensity between the intervention and comparator arms, it is unlikely that participant blinding could have been convincingly achieved. If unblinded personnel were acting as outcome assessors, they may have influenced assessment of the outcome. However, as the intervention was not found to be significant, this is unlikely. |
Some concerns | Data on repetition of self‐harm was obtained via self‐report. All eligible reported results for repetition of SH correspond to all intended analyses of the data. | Some concerns | Overall, this trial was rated as at some concerns for risk of bias as no specific information was reported as to whether the data that produced this result analysed in accordance with a pre‐specified analysis plan that was finalized before unblinded outcome data were available for analysis. |
| Stewart 2009 | Some concerns | Correspondence with trial authors clarified that "[n]ames of treatment groups were drawn from a container and participants were allocated to a treatment group". However, no information on allocation concealment reported. Referring to Table 1 (p.542), only data on certain clinical characteristics (e.g., hopelessness, satisfaction with treatment, social problem solving, and suicidal ideation scores at baseline were reported. Whilst there were no significant differences between the intervention and comparator arms on these variables, there were no data reported on any demographic factors at baseline. |
Low risk of bias | Correspondence with authors clarified that the “treatment condition was offered to the client via a phone call”, suggesting that participants would have known to which arm they had been allocated. Correspondence with trial authors further clarified that the therapist running the research was aware of which treatment condition the participant was being offered. There were no apparent deviations from the intended intervention. Correspondence with authors clarified that 10 participants dropped out of the comparator arm, 12 dropped out of the CBT arm, and 11 dropped out of the PST arm. Data were analysed using the modified intention to treat principle. |
Low risk of bias | Data were available for 100% of those randomised. | Low risk of bias | "…repeated attempt data from hospital chart audits that recorded re‐presentation to hospital for suicide attempts"(p.541). Repetition of self‐harm was ascertained in the same way between the intervention and comparator arms in this trial. Correspondence with authors clarified that the "therapist collected outcome data via self‐report measures and chart audits." However, neither clinical personnel were not blind to treatment allocation. Repetition of SH as determined by clinical and hospital records represents an observer‐reported outcome. |
Some concerns | "Measures were administered...directly following treatment (for the PST and CBT groups), and at two months follow‐up (for the TAU group)" (p.542). All eligible reported results for repetition of SH correspond to all intended outcome. "…repeated attempt data from hospital chart audits that recorded re‐presentation to hospital for suicide attempts" (p.541). All eligible reported results for repetition of SH correspond to all intended analyses of the data. |
Some concerns | Overall, this trial was rated as at some concerns for risk of bias as no specific information was reported as to whether the data that produced this result analysed in accordance with a pre‐specified analysis plan that was finalized before unblinded outcome data were available for analysis. |
| Wei 2013 | Some concerns | "[P]articipants...were randomly assigned...using a computerized randomization program" (p. 109). However, no information on allocation concealment reported. "The three groups did not significantly differ on age, education, minority race, marriage, sex, occupation, and mental disorder diagnosis" (p.110). |
Low risk of bias | Given the difference in therapeutic intensity between the intervention and comparator arms, it is unlikely that participant and clinical personnel blinding could have been convincingly achieved. There were no apparent deviations from the intended intervention. "All analyses were conducted using the intent‐to‐treat (ITT) principle..." (p.110). |
High risk of bias | Data were available for 72.0% of those randomised. Sensitivity analyses were not undertaken. "...the cumulative dropout rate [at post‐intervention] was 32.9% (n = 27) for the cognitive therapy group, 30.0% (n = 24) for the telephone intervention group, and 20.8% (n = 16) for the control group; the proportion of participants with missed assessment of three groups was not significantly different" (p.110). No other information on causes of missingness reported. |
Some concerns | "...research assessors followed up patients by telephone using measures of a detailed structured questionnaire...[to assess] suicidal history of patients" (p.110). However, previous work has demonstrated that self‐harm prevalence estimates derived from self‐report may be underestimated, and supplementing prevalence estimates with medical or clinical record information is advisable (Mars 2016). Repetition of self‐harm was ascertained in the same way between the intervention and comparator arms in this trial. Given the difference in therapeutic intensity between the intervention and comparator arms, it is unlikely that participant blinding could have been convincingly achieved. If clinical personnel were acting as outcome assessors, they may have influenced assessment of the outcome. However, as the intervention was not found to be significant, this is unlikely. |
Some concerns | "At the 3 months, 6 months, and 12 months post baseline assessments, the research assessors followed up patients..." (p.110). All eligible reported results for repetition of SH correspond to all intended outcome. "...research assessors followed up patients by telephone using measures of a detailed structured questionnaire...[to assess] suicidal history of patients" (p.110). All eligible reported results for repetition of SH correspond to all intended analyses of the data. |
High risk of bias | Overall, this trial was rated as some concerns for risk of bias as missingness in the outcome could have depended on its true value and analyses did not correct for bias, nor were sensitivity analyses undertaken to investigate the potential effect of missing data. |
| Weinberg 2006 | Low risk of bias | "Subjects were randomly assigned..." (p. 485). Correspondence with trial authors clarified that "subjects were asked to choose between 2 similar envelopes..." However, detail on the randomisaton method was not reported. Additionally, it was not clear whether these envelopes were sequentially numbered. There were no significant differences between the intervention and comparator arms for any of the demographic characteristics and clinical variables measured (Table 1, p.486). |
Low risk of bias | Given the difference in therapeutic intensity between the intervention and comparator arms, it is unlikely that participant and clinical personnel blinding could have been convincingly achieved. There were no apparent deviations from the intended intervention. Although "[a]ll [intervention] participants completed 6 sessions of MACT. Two [comparator] group participants were not available for the post‐treatment assessments" (p. 485). Nevertheles, "[a]ll participants were interviewed at the 6 months follow up" (p.485), suggesting that intention‐to‐treat analyses were undertaken. |
Low risk of bias | Data were available for 100% of those randomised (by the six‐month assessment). | Some concerns | Repetition of self‐harm was ascertained from the "Parasuicide History Interview‐PHI " (p.486). However, previous work has demonstrated that self‐harm prevalence estimates derived from self‐report may be underestimated, and supplementing prevalence estimates with medical or clinical record information is advisable (Mars 2016). Repetition of self‐harm was ascertained in the same way between the intervention and comparator arms in this trial. Given the difference in therapeutic intensity between the intervention and comparator arms, it is unlikely that participant blinding could have been convincingly achieved. If clinical personnel were acting as outcome assessors, they may have influenced assessment of the outcome. However, as the intervention was not found to be significant, this is unlikely. |
Some concerns | "The follow‐up assessments by [sic] performed after completion of the [intervention] (e.g, 6‐8 weeks after baseline assessments) and at a similar time point in the control group" (p.486). All eligible reported results for repetition of SH correspond to all intended outcome. Repetition of self‐harm was ascertained from the "Parasuicide History Interview‐PHI " (p.486). All eligible reported results for repetition of SH correspond to all intended analyses of the data. |
Some concerns | Overall, this trial was rated as at some concerns for risk of bias as no specific information was reported as to whether the data that produced this result analysed in accordance with a pre‐specified analysis plan that was finalized before unblinded outcome data were available for analysis. |