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Table 1 Primary and secondary objectives, research questions, and hypotheses

From: Comparing the feasibility, acceptability, clinical-, and cost-effectiveness of mental health e-screening to paper-based screening on the detection of depression, anxiety, and psychosocial risk in pregnant women: a study protocol of a randomized, parallel-group, superiority trial

a
Primary objective Research question Outcome Measures Testable hypothesis
To compare the feasibility and acceptability of mental health e-screening versus paper-based screening. Is mental health e-screening as or more feasible and acceptable to pregnant women and their healthcare providers than paper-based screening? Feasibility: % women in intervention and control groups reporting that screening is easily done as a component of routine prenatal care; mean CAE score Quantitative: Mean CAE scores and % of women responding affirmatively to questions of feasibility and acceptability will be similar or significantly higher in the intervention group (indicating greater feasibility/acceptability) compared to the control group
Feasibility
Example (CAE): I liked/would like using the tablet to answer these questions
Acceptability: % of participants in intervention and control groups reporting that screening is acceptable; % of participants reporting that questions about emotional health were easy to understand and easy to navigate around on the tablet Acceptability
Example: (1) I did not/would not like answering questions on a tablet because it felt/would feel impersonal  
Qualitative:
Semi-structured interviews
b
Secondary objective Research question Outcome Measure Testable hypotheses
1. To compare the level of detection of symptoms of prenatal depression, anxiety, and psychosocial risk in e-screening versus paper-based screening Compared to paper-based screening, what is the effect of mental health e-screening in pregnant women on the detection of prenatal depression, anxiety, and psychosocial risk? Proportion of women scoring above cutoff point of EPDS for depression and anxiety; proportion of women identified as some or high psychosocial risk on ALPHA EPDS Compared to the control group, a higher proportion of women in the intervention group will: (1) score 13 or more on the total EPDS (corresponding to probable prenatal depression); (2) score 4 or more on the anxiety subscale of the EPDS (Q3, 4, 5) (corresponding to probable prenatal anxiety); and (3) be identified as having some/moderate or high psychosocial risk on the ALPHA
ALPHA
2. To compare the level of disclosure of symptoms of prenatal depression and anxiety, and psychosocial risk in e-screening versus paper-based screening Compared to paper-based screening, what is the effect of mental health e-screening in pregnant women on the disclosure of prenatal depression, anxiety, and psychosocial risk? Level of disclosure: Mean subscale scores: (1) risk of disclosure; (2) benefits of disclosure DES Compared to paper-based screening, e-screening promotes greater disclosure (for example, the mean score risk of disclosure is significantly lower and benefit of disclosure is significantly higher in the e-screening group)
3. To determine factors associated with the acceptability and feasibility of mental health e-screening as well as disclosure What factors are associated with acceptability and feasibility of mental health e-screening in pregnant women? Identification of factors that significantly increase odds of acceptability and feasibility of e-screening Quantitative: (1) Demographic variables (age, gestation, marital status; ethnicity); (2) mental health history; current mental health status; EPDS scores; ALPHA category; (3) DES scores; (4) medical risk; (5) features of the screening instrument/process Factors that are significantly associated with acceptability and feasibility: mental health history, current mental health status (EPDS, ALPHA), disclosure (DES), medical risk; features of screening instrument
Qualitative:
Semi-structured interviews
Factors not associated: demographics
4. To compare the psychometric properties (sensitivity, specificity, cutoff points) of paper-based ALPHA and EPDS versus the e-version administered to medically low- and high-risk pregnant women Are the psychometric properties (for example, sensitivity, specificity, cutoff points) similar or better in the ALPHA and EPDS e-version compared to the paper-version when administered to pregnant women? Psychometric properties: sensitivity, specificity of ALPHA and EPDS in paper-based and e-versions ALPHA, EPDS, MINI The psychometric properties of e-version of ALPHA and EPDS are similar or better compared to paper-based version
5. To compare the cost-effectiveness e-screening compared to paper-based screening Is e-screening as a component of routine prenatal care cost effective when compared to paper-based screening? Cost-effectiveness: actual costs The expected incremental cost effectiveness of e-screening is cost effective at values of health considered acceptable in the Canadian healthcare system E-screening will be cost effective
  1. ALPHA: Antenatal Psychosocial Health Assessment; CAE: CASI Assessment Evaluation; DES: Disclosure Expectations Scale; EPDS: Edinburgh Postnatal Depression Scale; MINI: Mini International Neuropsychiatric Interview.