Trautman 2007.
Methods | Study design: quasi‐experimental control study Randomisation method: there were 3 distinct consecutive 2‐week enrolment periods. In the second enrolment period all eligible women who presented to the ED were assigned to the intervention group. During the first and third enrolment periods all eligible presenting women were allocated to a TCG Power calculation: yes Study dates: enrollment occurred between April and May 2003 |
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Participants | Setting: adult urban ED of a large university hospital serving a primarily socio‐economically disadvantaged, minority population Country: USA Inclusion criteria: women aged ≥ 18 years who presented to the ED for medical treatment Exclusion criteria: acute or critically ill presentation, illiteracy, impaired mental status, disorientation or apparent intoxication, would not separate from their partner; or already enrolled Numbers (%) of eligible recruited: 1005/1395 (72%) Numbers recruited: 1005; intervention group 411, control group 594 Number of dropouts: intervention group 0, control group 0 Numbers analysed (% recruited): 1005; intervention group 411 (100%), control group 594 (100%) Age range (years): 18 to 24 years 22.9%, 25 to 34 years 23.3%, 35 to 54 years 41.4%, ≥ 55 years 12.4% Marital status: married/living with partner 20%, never married 53.8%, divorced/separated 21%, widowed 5.2% Ethnicity: White 16.1%, Non‐white 83.9% Socioeconomic status (annual household income): < USD 10,000 42.4%, USD 10,000 to 15,999 20.6%, USD 16,000 to 20,999 12.2%, USD 21,000 to 35,999 14.8%, ≥ USD 36,000 10% Education: < high school 30.5%, high school or equivalent 42.3%, > high school 27.2% Children in household: yes 50.9% |
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Interventions | Intervention group
Control group
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Outcomes | Primary outcomes
Timing of measurement: immediate abstraction of data from medical records |
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Notes | Funding: no external funding | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | During 3 distinct, consecutive, 2‐week enrolment periods, all eligible women were asked to complete a computer‐based health survey. During the first and third enrolment periods, the computer‐based health survey did not include any IPV items. During the second enrolment period, it did include IPV screening items. It is likely that this type of allocation process introduced a high risk of bias due to systematic differences between the intervention group and the control group |
Allocation concealment (selection bias) | High risk | Patient service co‐ordinators recruited and obtained consent from participants. There was no blinding of recruiters to the potential allocation of women as the allocation for the period during which women presented to the ED was defined in advance and not concealed in any way explained in the report. Therefore, awareness of the allocation could have influenced how women were recruited. Furthermore, the experimental allocation for that period may have become inadvertently known to some women through interactions with other participants and staff influencing their decision to participate or not |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Women approached were told that this was a study about women's health whereby they would be "asked to answer questions about themselves on a computer and to allow their medical record to be reviewed by study personnel." Thus, there was some blinding of women to the purpose of the study. However, healthcare personnel were unblinded as "the medical records of all subjects were attached by coordinators to participants medical records to alert treating staff" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated that research assistant was unblinded as "the medical records of all subjects were reviewed by a research assistant to determine whether there was any documentation in the record" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There were no dropouts although we acknowledge that it was unclear how trialists dealt with missing data within variables |
Selective reporting (reporting bias) | Unclear risk | There was no reference to a study protocol and therefore insufficient information to permit a judgement of 'low' or 'high' risk of bias |
Other bias | High risk | Protection against contamination: the process of the providers consulting with women in the control group in the third, 2‐week block following the 2‐week intervention group block could have contaminated their interactions with participants in the control group. In fact, the authors state, "Three study periods were used to determine whether usual care related to intimate partner violence would return to baseline (i.e. first enrolment period) in the third enrolment period when the intimate partner violence questions were removed or whether it would be higher as a result of the computerized intimate partner violence screening during the second study period". There is some risk that an insensitive instrument was used to measure referrals with referrals applying to social workers only (which could have led to an underestimate of physician referring) |
A‐CASI: audio computer‐assisted self interviews; ALPHA: Antenatal Psychosocial Health Assessment; CAS: Composite Abuse Scale; CASI: computer‐assisted screening interview; CES‐D: Centre for Epidemiological Studies ‐ Depression; ED: emergency department; FTFI: face‐to‐face interview screening; HCP: healthcare professional; IPV: intimate partner violence; ITT: intention‐to‐treat; LTFU: loss to follow‐up; NS: non‐significant; PVS: Partner Violence Screen; CTS2S: Revised Conflict Tactics Scale‐Short Form; RCT: randomised controlled trial; RR: risk ratio; SD: standard deviation; SF: Short Form; TCG: treatment control group; VAWS: Violence Against Women Scale; WAST: Woman Abuse Screening Tool; WIC: Women, Infants, Children's (clinic)