Tsur 2008.
Methods | Individual randomised controlled trial. Estimated that use of contraception would be 50% in the control group, and a sample size of 100 would be required to detect 30% improvement in contraceptive use, with 80% power at a 0·05 level of significance | |
Participants | 108 females of reproductive age (16 to 45 years of age), some users and some not users of contraception, using or planning to use isotretinoin (a drug for acne), who phoned the Drug Consultation Centre at Assaf Harofeh Medical Center in Israel seeking advice regarding isotretinoin | |
Interventions | Control group: Routine care comprised information on Isotretinoin including contraceptive use only during the initial interview. Intervention group: automated intervention aimed to increase contraception use and comprised routine care plus additional information about teratogenic risk and the importance of contraceptive use in mailed written form and by text messages sent to cellular phones 1 month and 2 months after the initial call | |
Outcomes | Primary outcome: contraceptive use in women taking isotretinoin (methods of contraception not stated). Secondary outcomes: use of 2 contraceptives, sexual activity, contraceptive use amongst sexually active participants. All outcomes assessed by phone call at 3 months | |
Behaviour change techniques | As defined by study authors: not described According to Abraham and Michie's typology: 2 behaviour change techniques used (see Table 2) |
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Notes | 5 participants (5%) lost to follow‐up at 3 months and not included in the final analysis. Differential loss to follow‐up between intervention and control groups not stated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers kept in sealed envelopes |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not described in adequate detail. Sealed envelopes used, but unclear whether they were sequentially numbered and opaque |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding possible; outcome may have been influenced by lack of blinding |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information on whether outcome assessors were aware of allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing outcome data balanced in numbers across intervention groups |
Selective reporting (reporting bias) | Unclear risk | Study protocol not available. The primary outcome is reported using measurements that were not prespecified in the Methods section of the paper |
Other bias | High risk | Possibility of detection (social desirability) bias with self report measures of contraception use |
OC: oral contraceptive
STI: sexually transmitted infection