Table 1.
Outcome assessment listed per study aim
| Research aim | Outcome measure | Data source |
|---|---|---|
| Effectiveness of individual PCC consultations | ||
| Primary outcomes | ||
| Folic acid suppletion | Self-reported folic acid use Biomarker (erythrocyte folate) confirmed folic acid suppletion |
Questionnaire and blood analysis at first consultation and 3 months after first consultation |
| Smoking | Self-reported smoking cessation Biomarker (serum cotinine) confirmed smoking cessation |
Questionnaire and blood analysis at first consultation and 3 months after first consultation |
| Alcohol | Self-reported cessation of alcohol consumption Self-reported reduction of alcohol consumption Biomarker (serum %CDT; urinary EtG or PeTH) confirmed reduction or cessation of alcohol consumption |
Questionnaire and blood/urine analysis at first consultation and 3 months after first consultation |
| Illicit substance use | Self-reported cessation of illicit substance use Biomarker (drug assessment in urine) confirmed cessation of illicit substance use |
Questionnaire and urine analysis at first consultation and 3 months after first consultation |
| Effectiveness of recruitment strategy | ||
| Primary outcomes | ||
| Characteristics of the cohort measured by Andersen's model | Characteristics of women who utilised the PCC health service according to the framework of the substudy (figure 1) | Questionnaire at first consultation |
| Outreach of the municipal letter | Proportion of women successfully recruited through the letter from the municipality in relation to the number of women approached with a letter from the municipal health service/municipality Characteristics of women successfully recruited after receiving the letter from the municipality in relation to characteristics of women residing in the selected neighbourhood(s) |
Data on women successfully recruited (the Gemstracker database) and data from women included in the study (questionnaire 1). (Anonymous) Municipal administrative records provide characteristics of the target population: all women aged 18–42 residing in the high-risk neighbourhood |
| Outreach of the GP letter | Proportion of women successfully recruited in relation to the number of women approached by a letter from their general practice. Characteristics of these women in relation to characteristics of women residing in the selected neighbourhood(s) |
Data on women successfully recruited (the Gemstracker database) and data from women included in the study (questionnaire 1). (Anonymous) register of women who were sent a letter by general practices. (Anonymous) Municipal administrative records provide characteristics of the target population: all women aged 18–42 residing in the high-risk neighbourhood |
| Outreach of the Preconception health educators | Proportion of women successfully recruited after being approached about the service during a peer health education session. Characteristics of these women in relation to characteristics of women residing in the selected neighbourhood(s) |
Data on women successfully recruited (the Gemstracker database) and data from women included in the study (questionnaire 1). Questionnaires of participants of preconception health education sessions (Anonymous) Municipal administrative records provide characteristics of the target population: all women aged 18–42 residing in the high-risk neighbourhood |
| Outreach of the Child Welfare service | Proportion of women successfully recruited after being approached during a visit to the Child Welfare service Characteristics of these women in relation to characteristics of women residing in the selected neighbourhood(s) |
Data on women successfully recruited (Gemstracker database) and data from women included in the study (questionnaire 1). (Anonymous) Municipal administrative records provide characteristics of the target population: all women aged 18–42 residing in the high-risk neighbourhood |
CDT, carbohydrate deficient transferrin; EtG, ethylgluconeride; PCC, preconception care; PeTH, phosphatidylethanol.