Appendix B
Field Costs for the National Children’s Study: First 7 Years
The panel was charged with evaluating the proposed methodologies for the National Children’s Study (NCS) Main Study, including whether such methodologies are likely to produce scientifically sound results. In trying to carry out this part of our charge, the panel found that the relevant cost information was not available (see Chapter 5). Thus, in order to assess alternative approaches with key design elements, such as sampling frame and design, the recruitment and retention process, and broad aspects of the interview schedule and data collection, the panel commissioned two consultants—Lisa Schwartz of Mathematica Policy Research and Randall Olsen of Ohio State University—to construct a cost model of several design options. They collected cost information relevant to the modeling at meetings and through telephone conversations with staff from the NCS Program Office. As explained below, most of the NCS Program Office cost suggestions were adopted and used in this analysis, and the Program Office staff were invited to “fact-check” the model assumptions and results. Key results of the cost analysis are summarized in Chapter 5. This appendix details the assumptions behind the cost model.
SCOPE OF THE COST ANALYSIS
The assessment was limited to the field costs that would vary to a material degree for the design options the panel considered. Specifically, the budget models focused on recruitment, retention, and data collection costs through the first 7 years of the Main Study. Our general objective was to assess the cost
implications of key design tradeoffs that were roughly consistent with the total estimated field costs of the current proposed Main Study design.
Despite the large 7-year total field costs we estimate—some $1.3 to $1.6 billion—it is important to realize that our estimates omit many potentially sizable study costs, although they are not materially affected by total sample size or recruitment strategy. Those omitted costs include
MODELING ASSUMPTIONS
To the extent possible, the panel constructed a cost model based on information provided by the NCS Program Office. When cost information was not available, we relied on the experience of our consultants (who have a combined 40 years of experience with survey research and several contract survey research firms) to develop reasonable estimates. The cost models reflect the breadth of
their experience in budgeting various components of large, complex data collection efforts.
For the most part, the Program Office agreed with our cost assumptions. When their review suggested changes to our assumptions (either up or down), we usually revised our models accordingly. These changes to our initial assumptions did not produce major changes to the overall estimates. As described in the penultimate section of this appendix, we questioned only two NCS Program Office assumptions as being inconsistent with the experience of the consultants who conducted the cost analysis. In one case, the need for some in-person interviews at birth, the consultant’s assumption was used in the cost analysis.
We took as our baseline model the design as described by the NCS Program Office in documents submitted to the panel.1 We begin with a high-level summary of the designs included in our cost models. Across all models, we assume the yield from provider-based sample recruiting is measured by the number of prenatal enrollments that lead to a sampled birth. That is, if a woman agrees to the study and makes an appointment for the first prenatal interview, her agreement is not counted as a successful recruitment until and unless the woman completes the first prenatal interview and then stays with the study through childbirth.
Based on the information provided to the panel, we assume that 250 hospitals are the primary sampling units (PSUs).2 Also based on Program Office information, we assume that 50 percent of women who are approached will refuse to participate and that of the women who agree to participate, 20 percent will drop out of the study after their first prenatal interview and before birth. The Program Office estimates the average enrolled prenatal birth mother will receive 1.5 prenatal interviews. Accounting for attrition, this means about 1.7 prenatal visits are conducted for every birth brought into the study by prenatal provider-based recruitment.
The secondary sampling units are non-hospital-based providers (i.e., practices), and we assume, on average, five such providers are recruited per sampled hospital (N = 1,250 providers). Recruitment of hospitals and providers and sample enrollment occurs in four sequential groups of PSUs. Each group of PSUs is tracked for 4 years, but the initial year for each group is staggered: that is, recruitment in group A takes place in years 1 through 4,
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1Our work is based on materials received from the Program Office through January 2014, but we note that there may have been subsequent changes to this design, which would not be reflected in our cost assessments. However, the major cost drivers are parameterized in the spreadsheet, which is available at http://sites.nationalacademies.org/DBASSE/CNSTAT/National_Childrens_Study_2014/index.htm [July 2014]. .
2At the time of this report, NCS anticipated that between 200 and 300 hospitals would comprise the study’s primary sampling units and estimated that they would recruit five providers per hospital.
group B in years 2 through 5 and so forth.3 This approach spreads out the higher costs of enrollment and the heavy first-year data collection over more years so that peak costs are not as high as they otherwise would be. Using this approach, peak costs occur in year 4 when all PSUs are involved in active recruitment or data collection. The last birth would be enrolled in year 7 of the data collection phase: hence, our analysis is budgeted over 7 years. In years 8 and later, the data collection costs we estimate fall until they reach a steady state of about $50 million (plus an adjustment for inflation). This approach reflects a case load averaging 50,000 active cases per year4 minus attrition.
We note that for modeling purposes, recruitment costs are influenced by which of two data collection protocols is used for a case. As noted above, the prenatal protocol, the more costly of the two, includes, on average, 1.5 prenatal in-home interviews, which include environmental and biospecimen collection. All women recruited prenatally and all women in the preconception sample once pregnancy is confirmed receive this protocol. The protocol for women recruited at delivery includes a take-home kit for collecting and shipping environmental samples: in all other ways the women recruited after delivery receive the same schedule of interviews. All women recruited at the hospital and women in the non-probability (non-preconception) sample receive the protocol for women recruited at delivery.
The scientific value of the prenatal sample led the panel to consider options for increasing the prenatal fraction of the sample without increasing the total field costs, which could be done in a variety of ways. As we detail below, dropping the preconception sample and then making 97 percent of the sample prenatal through provider-based recruitment comes very close to achieving the goal. To match the 7-year cost of the baseline model, the sample only has to be reduced to about 96,000. This result reflects the high cost of the preconception sample, primarily due to the large number of women who must be tracked to achieve 5,000 enrolled births.
The Cost Models
The panel’s cost analysis is based on eight models, of which the first is the baseline:
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3At the time of this report, NCS anticipated that provider-based recruitment will occur over a 3-year period in order to ensure that children born to enrolled women are born in year 4 of recruitment; delivery-based recruitment will occur over 4 years.
4After age 5, children will be monitored once every 2 years. Thus, to monitor 100,000 children, there will be 50,000 cases per year.
Cost Model Assumptions
In this section, we provide information on some of the key cost parameters for the NCS field work, in five areas: general, sample recruitment and retention, interviewer recruitment and training, data collection, and specimen processing.
General Assumptions
Sample Recruitment and Retention
and that no additional review boards will require approval. Thus, no IRB-related costs are included in our analysis.
Interviewer Recruitment and Training
Data Collection
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5Difficult cases often require repeated visits due to broken appointments, as well as visits to determine where the respondent is located and to secure additional locating information from former neighbors. Younger households are often more mobile, which makes some cases difficult because of locating problems and not just because of reluctance or resistance to cooperation. The cases that are not “easy” or “hard” are noninterviews.
6Other expenses include additional mailings and an in-house locating effort, such as electronic database searches, to obtain new contact information.
annual cost $1,550 per interviewer. The cost of Oragene kits and specimen supplies is $50 per case. The cost for collecting, packing, mailing, labeling and assaying 5 percent of the environmental and blood samples7 is $190 per in-person interview.
Specimen Processing
Our assumptions do not include the costs of repository processing and storage of biological and environmental samples, which we estimate at $126 million over the first 7 years ($18 million in annualized costs), based on an inventory of 42,000,000 primary and derivative samples. We note these for informational purposes only as they are significant.
COSTS AND COST DRIVERS
Based on these assumptions and the resources implied for the NCS design, we estimated the costs of our models. We begin this section with the major factors that influence the costs.
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7NCS plans to assay or analyze 5 percent of environmental and biological samples for quality control purposes only.
For the baseline and models 2 through 8, Table B-1 shows our estimated field costs for the first 7 years of the NCS, the cost differential relative to the baseline, and the sample size that would make each model cost neutral with respect to the baseline. (This table also appears as Table 5-1 in Chapter 5). A notable feature of the table is that while moving to an overwhelmingly prenatal protocol for data collection increases costs, those additional costs are substantially offset by eliminating the preconception cohort. Modest reductions in the schedule of interviews or modest reductions in total sample size (or both) result in costs that are roughly equivalent to baseline costs. These alterations make it possible to collect a probability sample of births that is larger than the baseline proposal. Other adjustments are possible, but this provides a framework for looking at costs and reconciling them with budgets.
TABLE B-1 Field Costs of Alternative Sample Designs
| Model and Sample Size* | Total Field Cost (in millions of $) | Base Field Cost–Modeled Field Cost (in millions of $) | Size of Main Sample (including siblings) for Field Cost Neutrality |
| N = 100,000 | |||
| Baseline: current design—one-half prenatal and one-half birth recruitment for 90,000 births, plus 5,000 preconception supplemental sample and 5,000 convenience sample (Model 1) | $1,495 | NA | NA |
| Maximum prenatal recruitment plus preconception supplemental sample, and convenience sample (Model 2) | $1,631 | ($135) | 89,179 |
| Maximum prenatal recruitment and convenience sample but no preconception supplemental sample (Model 3) | $1,542 | ($47) | 96,256 |
| Drop one in-home and one telephone interview from Model 3 (Model 4) | $1,348 | $147 | 113,940 |
| Drop one telephone interview from Model 3 (Model 5) | $1,492 | $3 | 100,256 |
| Drop one in-home interview from Model 3 (Model 6) | $1,398 | $98 | 108,836 |
| Have only one prenatal interview in Model 3 (Model 7) | $1,488 | $7 | 100,600 |
| N = 96,000 | |||
| Maximum prenatal recruitment, no preconception or other supplemental sample and cost neutrality (Model 8) | $1,495 | ($0) | 96,256 |
NOTES: All cost figures are based only on costs of fielding the study and thus do not represent the full cost of the NCS; see text for discussion. Cost of convenience sample assumed to be equal to cost of equal-sized prenatal sample.
*See text for details of the panel’s models.
TABLE B-2 Year-by-Year Cost Comparisons Across Models (in millions of $)
| Year | Baseline | Model 2 | Model 3 | Model 4 | Model 5 | Model 6 | Model 7 | Model 8 |
| 1 | $ 62 | $ 70 | $ 62 | $ 53 | $ 60 | $ 56 | $ 59 | $ 61 |
| 2 | 127 | 142 | 129 | 110 | 124 | 115 | 122 | 126 |
| 3 | 206 | 230 | 212 | 180 | 204 | 188 | 201 | 206 |
| 4 | 307 | 340 | 317 | 271 | 306 | 283 | 304 | 308 |
| 5 | 294 | 320 | 306 | 266 | 296 | 276 | 295 | 296 |
| 6 | 272 | 291 | 281 | 251 | 274 | 259 | 275 | 272 |
| 7 | 227 | 238 | 234 | 216 | 229 | 221 | 233 | 226 |
| Total | 1,495 | 1,631 | 1,542 | 1,348 | 1,492 | 1,398 | 1,488 | 1,495 |
NOTE: See text for discussion.
Table B-2 shows the estimated yearly costs for the eight models as well as the 7-year total. The data show that, despite spreading sample recruitment costs over 7 years instead of four, field costs peak at a level above the fiscal 2014 appropriation level. Attempting to spread recruitment costs over even more years may reduce the peak but increase total program costs.
Questionable Assumptions
The panel questioned only two Program Office assumptions as being inconsistent with the experience of the consultants who conducted the cost analysis for us, recruiting costs and need for follow-up. First, the Program Office estimates that the level of effort needed to recruit for the Main Study will be the same as that required for the Vanguard Study. However, the original Vanguard Study contractors were primarily universities, many of which also had medical schools and university-affiliated hospitals. Staff affiliated with those universities or contractors acting on their behalf recruited hospitals, providers, and women for the study. In our judgment, these affiliations and the universities’ community-level “brand equity” likely had two effects: (1) they made it more likely that the entities they approached agreed to participate; and (2) the level of effort needed to gain that cooperation was less than it would otherwise be. We judged that it is unlikely that a contract research organization will be as effective in garnering support from a random sample of hospitals, providers, and women as an effort undertaken by a university or medical center with strong national or regional name recognition. While all of our models incorporate the Program Office’s recruiting assumptions, we note in Chapter 5 that the study may incur substantially higher costs if, in practice, contract research firms must expend more effort than estimated to achieve the study’s recruitment goals. A number of changes to recruiting assumptions could result from this change in staffing model:
Second, in all of our models including the baseline we assumed 15 percent of cases would need a follow-up visit after birth to retrieve specimens or conduct an interview. The Program Office assumes this would not be necessary, but we judge that the many distractions surrounding a birth, the possibility of rapid discharge from the hospital before the in-hospital interview is conducted, and the possibility some mothers simply would not get around to collecting environmental samples all suggested we allow for the need for an in-home visit shortly after birth.
Limitations of Our Cost Model
Apart from limiting its estimates to only the field costs of the NCS, our cost analysis has other noteworthy limitations. We believe our estimates are reasonable, but there are reasons that contractors may bid costs that differ from those presented here. For example, if the contracts are fixed-price rather than cost—reimbursement contracts, the uncertainties inherent in performing such a large and complex project may lead bidders to build in a “cushion” to cover uncertainties, such as subtle changes in the interpretation of the scope of work, delays created by procurement problems, or other administrative or governmentwide disruptions. If the work scope is not clearly defined due to uncertainties over specimen collection or interview content, contract modifications become more likely, and such changes are inherently less competitive, increasing costs. There is also the risk of a contractor winning a bid that is based on a low tender price and then being unable to perform the work within the dollar limits or finds the work technically more demanding than expected. Such a problem with one part of the project, say, technological infrastructure, can easily affect other parts. Subtle changes to questionnaires can, depending on the change, have serious cost implications that only become evident when they are fielded.
There are also risks inherent in survey projects for which respondent reaction and attitudes have unpredictable cost implications. For example, the plan to draw blood from the mother at every personal visit is a very aggressive plan in terms of the demands it places on respondents. This may lead to a less
cooperative respondent pool that may require more time, effort, and incentive payments to overcome. Alternatively, these demands may reduce costs because respondents leave the study in greater numbers. There are also regulatory risks. If regulations to which the NCS is subject become more stringent, this could easily generate unpredictable cost increases. These kinds of problems are not specific to the NCS, of course.