N. Supplemental digital content

Table SI. Summary of planned pregnancy cost

Author, year;
Study title / Description of pregnancy / Observation period / Comparison group / Number of pregnant women / Number of singleton births / Number of multiple births / Cost/charge breakdown / Reported cost/charge unit / 2012 USD / Delivery cost1
$
Katz, 2011;
Costs of Infertility Treatment: Results from an 18-month Prospective Cohort Study
After 18-month study period, participants' medical records were collected from physicians; successful pregnancies following treatment were recorded / 18 months / Cycle-based / 145 / 74 / 31 / Maternal / Mean total cost of successful pregnancy / 105,242 / 45,681
Medication only / 4 / 3 / 0 / 22,673 / 15,423
Intrauterine Insemination (IUI) with clomiphene citrate / 15 / 13 / 1 / 35,899 / 22,744
Intrauterine Insemination (IUI) with gonadotropins / 25 / 19 / 2 / 49,250 / 25,183
In Vitro Fertilization / 88 / 32 / 28 / 138,743 / 63,249
In Vitro Fertilization with donor egg / 13 / 3 / 4 / 163,335 / 73,986
Note:
[1] Study authors defined delivery cost as (Number of singleton deliveries x $12,539) + (Number of multiple deliveries x $95,860).

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Table SII. Summary of facility-related pregnancy cost

Author, year;
Study title / Description of pregnancy / Comparison group / Length of stay for deliveries
(in days) / Reported cost/charge unit / Cost/charge breakdown / 2012 USD
DelliFraine, 2011;
Cost Comparison of Baby Friendly and Non-Baby Friendly Hospitals in the United States
Costs associated with labor-and-delivery diagnosis-related codes were analyzed for each facility. / Non-baby friendly / Mean: 3.76 / Mean cost / Maternal and neonatal / 2,561
Baby friendly / Mean: 4.10 / Mean cost / Maternal and neonatal / 2,602

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Risk of bias assessment forms

Form A: Randomized controlled trial (RCT)

  1. Random sequence generation (selection bias); method reported to generate assignment sequence

()1Low risk of bias (A computer random number generator; Coin toss, shuffle cards or envelopes, throw dice or draw lots)

()2Unclear risk of bias (Article states that participants were randomized, but does not state the method of randomization (e.g., randomly divided into two groups, randomized patients using permuted blocks stratified by center); Other mathematical randomization technique)

()3High risk of bias

  1. Allocation concealment (selection bias); how was random assignment obtained?

()1Low risk of bias (Via telephone, fax, letter, or web request to an outside party or data coordinating center; Sequentially numbered AND opaque AND sealed envelopes; Sequentially numbered drug containers of identical appearance)

()2Unclear risk of bias

()3High risk of bias (Using an open random allocation schedule (e.g., a list of random numbers openly available); Assignment envelopes were used without appropriate safeguards (e.g., if envelopes were unsealed or non-opaque or not sequentially numbered); Alternation or rotation; date of birth; case record number)

  1. Blinding of participants and personnel (performance bias)

()1Low risk of bias (participants masked to the treatment assignment, those who treated patients masked to the treatment assignment)

()2Unclear risk of bias

()3High risk of bias

  1. Blinding of outcome assessment (detection bias)

()1Low risk of bias (participants masked to the treatment assignment, those who measured the clinical efficacy and safety outcomes masked to the treatment assignment)

()2Unclear risk of bias

()3High risk of bias

  1. Incomplete outcome data addressed (attrition bias); assessment of risk of bias of incomplete outcome data (Check “Yes”, “No”, or “Can’t tell” for each category).

()1Low risk of bias (No missing outcome data; The proportion of missing outcome data not enough to have a clinically relevant impact on the intervention effect estimate; Reasons for missing outcome data unlikely to be related to true outcome; Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups; Missing data have been imputed using appropriate methods)

()2Unclear risk of bias

()3High risk of bias (Reason for missing outcome data likely to be related to true outcome, with either imbalance in numbers or reasons for missing data across intervention groups; The proportion of missing outcomes enough to induce clinically relevant bias in intervention effect estimate; “As treated analysis” done with substantial departure of the intervention received from that assigned at randomization)

  1. Selective reporting (reporting bias); is there any evidence to suggest that the authors measured more outcomes than they reported?

()1Low risk of bias

()2Unclear risk of bias

()3High risk of bias (e.g., Three rating scales for cognition listed in Methods, but only one (with statistically significant results) is reported.)

Form B: Non-randomized study

  1. Selection bias: Based on the available study description, were the criteria explicitly described for individuals to be eligible for inclusion in the study population

()1Low risk of bias

()2Unclear risk of bias

()3High risk of bias

  1. Selection bias: Based on the available study description, does it appear that the association of interest in the population eligible for participation in the study may be different from the association in the target population?

()1Low risk of bias

()2Unclear risk of bias

()3High risk of bias

  1. Selection bias: Based on the available study description, does it appear that any participants/person-time were/was excluded from the analysis for the outcome?

()1Low risk of bias

()2Unclear risk of bias

()3High risk of bias

  1. Selection bias: Based on the available description of reasons for exclusion from analysis, does it appear that a similar proportion of participants/person-time were/was excluded in the exposed and unexposed groups for each reason?

()1Low risk of bias

()2Unclear risk of bias

()3High risk of bias

  1. Attrition bias: Based on the available study description, does it appear that any statistical methods have been used to account for missing data in order to minimize bias due to failure to follow-up and assess outcomes?

()1Low risk of bias

()2Unclear risk of bias

()3High risk of bias

  1. Detection bias: Based on the available study description, does it appear that the participants’ exposure status was ascertained without knowledge of the participants’ outcome status?

()1Low risk of bias

()2Unclear risk of bias

()3High risk of bias

  1. Detection bias: Based on the available study description, does it appear that exposure status was ascertained using the same protocol and measurement tool for all participants and for all time points of follow-up?

()1Low risk of bias

()2Unclear risk of bias

()3High risk of bias

  1. Information bias: Based on the available study description, does it appear that the methods for ascertainment of exposure status, outcome status or both were susceptible to misclassification?

()1Low risk of bias

()2Unclear risk of bias

()3High risk of bias

  1. Controlled for confounders: Based on the available study description, does it appear that analyses for the exposure-outcome association of interest have been adjusted for all relevant confounders?

()1Low risk of bias

()2Unclear risk of bias

()3High risk of bias

Form C: Retrospective database studies (ISPOR Task Force)

  1. Database bias: Have the data attributes been described in sufficient detail to determine whether there was a good rationale for using the data source?

()1Low risk of bias

()2Unclear risk of bias

()3High risk of bias

  1. Selection bias: Have the necessary linkages among data sources and/or different care sites been done appropriately, taking into account differences in coding and reporting across studies?

()1Low risk of bias

()2Unclear risk of bias

()3High risk of bias

  1. Data dredging bias: Was a data analysis plan, including study hypotheses, developed a priori?

()1Low risk of bias

()2Unclear risk of bias

()3High risk of bias

  1. Selection bias: For studies that are trying to make inferences about the effects of an intervention, does the study include a comparison group and have the authors described the process for identifying the comparison group and the characteristics of the comparison group as they relate to the intervention group?

()1Low risk of bias

()2Unclear risk of bias

()3High risk of bias

  1. Selection bias: Have the inclusion and exclusion criteria and the steps used to derive the final sample from the initial population been described?

()1Low risk of bias

()2Unclear risk of bias

()3High risk of bias

  1. Assessment bias: Are subjects eligible for the time period over which measurement is occurring?

()1Low risk of bias

()2Unclear risk of bias

()3High risk of bias

  1. Censoring bias: Were inclusion/exclusion or eligibility criteria used to address censoring and was the impact on study findings discussed?

()1Low risk of bias

()2Unclear risk of bias

()3High risk of bias

  1. Temporal bias: Are case (subjects) and endpoint (outcomes) criteria explicitly defined using diagnosis, drug markers, procedure codes, and/or other criteria?

()1Low risk of bias

()2Unclear risk of bias

()3High risk of bias

  1. Analytical assessment bias: Is there a clear temporal (sequential) relationship between the exposure and outcome?

()1Low risk of bias

()2Unclear risk of bias

()3High risk of bias

  1. Detection bias: Is the data, as collected able to identify the intervention and outcomes if they actually occurred?

()1Low risk of bias

()2Unclear risk of bias

()3High risk of bias

  1. Detection bias: Is there a link between the natural history of the disease being studied and the time period for analysis?

()1Low risk of bias

()2Unclear risk of bias

()3High risk of bias

  1. Controlled for confounders: If the goal of the study is to examine treatment effects, what methods have been used to control for other variables that may affect the outcome of interest?

()1Low risk of bias

()2Unclear risk of bias

()3 High risk of bias

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