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<script type="text/javascript" src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.boots.min.js"> </script><title>Methods - National Health Interview Survey Follow-up Health Study: Feasibility Evaluation of Adding an In-home Physical Examination to a National Health Survey - NCBI Bookshelf</title>
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<meta name="og:description" content="NHIS collects survey data annually on a broad array of health and sociodemographic topics from a large, nationally representative sample of the U.S. civilian noninstitutionalized population. The U.S. Census Bureau is the data collection agent for NHIS. A U.S. Census Bureau field representative (FR) visits the sampled addresses and attempts to gain cooperation from the household residents. Because this task has become more difficult in recent years, additional training to address doorstep concerns has been added to FR NHIS training. However, FRs have always been provided with suggested language and approaches, and then instructed to use their judgement to choose the appropriate language for each case. Most NHIS FRs are highly experienced at gaining cooperation; they are usually members of the communities they work in and have worked on the survey for years (5). This unscripted approach to gaining cooperation is used by many other surveys, including NHANES. This is worth noting because the NHIS FHS took a different approach to the process of gaining cooperation.">
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yet</button><a id="jr-fip-next" class="wsprkl btn" title="Jump to next match">▶</a></nav></nav></div><div id="jr-epub-interstitial" class="hidden"></div><div id="jr-content"><article data-type="main"><div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/CreativeWork"><div class="meta-content fm-sec"><div class="fm-sec"><h1 id="_NBK612043_"><span class="title" itemprop="name">Methods</span></h1><p class="fm-aai"><a href="#_NBK612043_pubdet_">Publication Details</a></p></div></div><div class="jig-ncbiinpagenav body-content whole_rhythm" data-jigconfig="allHeadingLevels: ['h2'],smoothScroll: false" itemprop="text"><div id="sr02-210.s5"><h2 id="_sr02-210_s5_">NHIS</h2><p>NHIS collects survey data annually on a broad array of health and sociodemographic topics from a large, nationally representative sample of the U.S. civilian noninstitutionalized population. The U.S. Census Bureau is the data collection agent for NHIS. A U.S. Census Bureau field representative (FR) visits the sampled addresses and attempts to gain cooperation from the household residents. Because this task has become more difficult in recent years, additional training to address doorstep concerns has been added to FR NHIS training. However, FRs have always been provided with suggested language and approaches, and then instructed to use their judgement to choose the appropriate language for each case. Most NHIS FRs are highly experienced at gaining cooperation; they are usually members of the communities they work in and have worked on the survey for years (<a href="/books/n/sr02210/sr02-210.rl1/?report=reader#sr02-210.r5">5</a>). This unscripted approach to gaining cooperation is used by many other surveys, including NHANES. This is worth noting because the NHIS FHS took a different approach to the process of gaining cooperation.</p><p>Once the household resident agrees to participate, the FR collects a household roster including basic demographic information for all household members. Next, the instrument randomly selects one adult (the Sample Adult) and one child, if applicable (the Sample Child), per household. The Sample Adult answers for themselves unless they are physically or mentally unable to do so, in which case a knowledgeable adult proxy may answer on their behalf. An adult knowledgeable about the Sample Child’s health answers on behalf of the child. NHIS interviews are typically conducted in person, with telephone follow-up when necessary. However, the COVID-19 pandemic impacted typical interviewing procedures and, as a result, a higher percentage of Sample Adult interviews were conducted in part or entirely by telephone after March 2020 compared with before that time. Specifically, during the period when FRs were introducing Sample Adults to the NHIS FHS during June through September 2021, 56.8% of all Sample Adult interviews were conducted in part or entirely by telephone. In contrast, in 2019, 34.3% of Sample Adult interviews were conducted at least partially by telephone (<a href="/books/n/sr02210/sr02-210.rl1/?report=reader#sr02-210.r6">6</a>).</p><p>The NHIS interview is about 1 hour long. NHIS respondents do not receive an incentive for participating.</p></div><div id="sr02-210.s6"><h2 id="_sr02-210_s6_">NHIS and NHANES Collaboration</h2><p>Although NHIS took the lead in planning the NHIS FHS, including coordinating with the U.S. Census Bureau and selecting the primary contractor who scheduled the appointments and conducted the examinations, NHANES contributed key infrastructure and expertise, primarily but not exclusively for the physical examination, laboratory work, and results reporting aspects of the project.</p><div id="sr02-210.s7"><h3>IT Security Boundary</h3><p>The NHIS FHS used the NHANES IT security authorization boundary, which included several components adapted for this pilot study. The foundational component was the information technology infrastructure, such as the database that included Sample Adult information, results of contact attempts, home examination appointment information, examination results, and laboratory results. The next component was the internal web application that schedulers and recruitment specialists used to interact with the study scheduling system, and that they and the health representatives used to interact with the electronic record of contacts system. Along with this, health representatives used a separate application to enter the results from the home examination. The staff completed these tasks using smart phones, tablets, and laptops dedicated to this project and configured to keep all information secure within the security authorization boundary. The last components included the VPN (virtual private network) gateway, which ensured secure encryption for transmitting home examination results from the field instrument to the database, as well as the secure File Transfer Protocol “mailbox” used for receiving laboratory results from the Quest Diagnostics laboratory.</p></div><div id="sr02-210.s8"><h3>Medical Officer</h3><p>The NHANES medical officer advised the planning team on all clinical aspects of the study design and served as the public-facing medical officer for the project, as needed. In the results report that participants received after their examination, the medical officer was listed as the contact person for questions about their results. The medical officer also called participants whose biospecimen test results required expedited reporting because the results were significantly outside of the normal range, indicating a potentially life-threatening condition, referred to in this report as critical results. See “Preliminary Report of Findings” and “Critical Laboratory Test Value Reporting” for more information.</p></div></div><div id="sr02-210.s9"><h2 id="_sr02-210_s9_">NHIS FHS Interagency Agreement</h2><p>To understand the reasons for many of the study design decisions, it is necessary to understand the other non-NCHS groups that worked on the study. First, was the U.S. Census Bureau. The Sample Adult was introduced to the study by the Census FR at the end of the NHIS Sample Adult interview. FRs’ experience at gaining cooperation and the rapport they build during NHIS interviews was expected to make them ideal recruiters. However, because the U.S. Census Bureau’s authorizing legislation includes conducting surveys but does not include conducting health examinations, NHIS FRs could not take a substantive role in the NHIS FHS. A substantive role was defined by the U.S. Census Bureau as anything other than the activity that the FRs already perform, namely reading NHIS instrument text and inputting respondent answers. Specifically, FRs could inform the Sample Adult about the study by reading text from the NHIS instrument screen, answer questions about the study using a Frequently Asked Questions (FAQ) form provided in the instrument, and record the contact information that the Sample Adult shared with the study schedulers through NHIS instrument questions. Because these activities were defined by the U.S. Census Bureau as separate from the study, the FRs could perform them.</p><p>The restriction of FRs to the activities they already perform when administering the NHIS instrument had a cascading impact on NHIS FHS study methods and FR training. Because this process was required to be scripted, FRs could not use their full cooperation-gaining skills when introducing the study to the Sample Adults and asking about their willingness to be contacted to schedule an appointment. Also, there were restrictions on the wording of that script, as well as on the training that the FRs received in reading it. For example, the introduction was required to include the information that the U.S. Census Bureau played no role in the study. Also, the instrument text that the FRs read about NHIS FHS could not be described in the training as an “invitation” to participate because that suggested that the FRs played a role in the study. The section “Successes and Challenges of Informing Sample Adult About Study and Related FR Tasks” discusses how these restrictions may have impacted the percentage of NHIS Sample Adults who agreed to be contacted.</p></div><div id="sr02-210.s10"><h2 id="_sr02-210_s10_">External Contractors</h2><p>Because NHIS does not include a home examination, it was necessary to contract with a company who could handle the appointment scheduling, home examinations, biospecimen analysis, and results reporting. Because the study involved data covered by the Confidential Information Protection and Statistical Efficiency Act (CIPSEA), the law that governs the collection and protection of data collected by federal statistical agencies, the contractor needed to meet the strict requirements of this authorization. Only a limited number of contractors were able to meet the CIPSEA requirements in time for the start of the study.</p><p>Westat, which collected NHANES data at the time, was selected as the FHS contractor. Westat managed all field operations, including appointment scheduling, noncontact and refusal follow-up, refusal conversion, home examinations including participant incentive provision, and biospecimen analysis and results reporting. Westat also developed and provided the training for the schedulers, recruitment specialists, and phlebotomists; prepared the staff competency assessments; and provided the data collection systems and information technology for all but one step of the process. (That step was identifying study-trained ExamOne phlebotomists available at the appointment time requested by the participant. More information on this topic is provided in “COVID-19 Screening and Setting the Appointment.”) Westat also supplied each project staff member with an encrypted laptop, tablet, and smart phone, configured to keep the data safe within the security authorization boundary, for their use during the pilot study. Finally, Westat reported the results to participants, reported results requiring priority reporting to the medical officer, and delivered a data file and documentation to NCHS.</p><p>Westat also subcontracted with ExamOne, which administered staff competency assessments, attempted to contact the Sample Adults, scheduled participant appointments, and completed the home health examinations. The ExamOne staff who were trained and passed the competency assessment for NHIS FHS scheduling protocols are referred to in this report as schedulers. ExamOne phlebotomists who were trained and passed the competency assessment for NHIS FHS scheduling and home visit protocols are referred to in this report as health representatives.</p><p>Certain ExamOne business practices and policies impacted how appointment scheduling responsibilities were distributed between Westat and ExamOne staff. Specifically, ExamOne phlebotomists were not used to gaining cooperation from study participants, so ExamOne expressed doubt they would be able to recruit adequate phlebotomists to work on the study if recruitment was part of their responsibilities. Furthermore, ExamOne was concerned that any recruited phlebotomists might have trouble following the study’s scheduling contact attempt protocol and convincing reluctant Sample Adults to participate. Lastly, only ExamOne staff had access to the proprietary ExamOne portal and calendar where the ExamOne phlebotomists document their availability; Westat staff could not access it. As a result, ExamOne’s standard scheduling staffing model was implemented. ExamOne schedulers made the contact attempts and assigned phlebotomists to cases when scheduling the initial appointment with the participant.</p><p>ExamOne subcontracted with Quest Diagnostics, a national provider of diagnostic testing certified by the Clinical Laboratory Improvement Amendments (CLIA), to receive the blood and urine specimens and conduct the biospecimen analyses. Quest Diagnostics’ main goal is to complete biospecimen testing for healthcare systems, physicians, and hospitals, but it also provides biospecimen testing services for research studies. Most of these are clinical research studies.</p></div><div id="sr02-210.s11"><h2 id="_sr02-210_s11_">NHIS FHS Study Design</h2><div id="sr02-210.s12"><h3>Overview</h3><p>FRs told a small, purposeful sample of Sample Adults at the end of their interview that NCHS was inviting them to participate in a follow-up health study and asked if NCHS could provide the contractor hired to collect the study data, ExamOne, with the Sample Adult’s contact information so the contractor could contact them to schedule an appointment. If the Sample Adult agreed, their information was collected and shared, through NCHS, to Westat. Westat then entered the information into the system where it could be accessed by ExamOne staff. ExamOne and Westat attempted to contact the Sample Adults by phone and, if necessary, followed up with letters, text messages, and e-mails, following a specific protocol for all contact attempts. If an ExamOne scheduler was able to schedule an appointment, the scheduler then assigned a study-trained ExamOne phlebotomist to conduct the home visit. That health representative then attempted to confirm and keep the appointment, obtain informed consent, and complete the home visit. After each successful home visit, the health representative packaged and shipped the blood and urine samples to Quest Diagnostics, ExamOne’s subcontractor. Quest Diagnostics laboratory technicians tested the urine samples for glucose, hemoglobin, and analytes related to kidney function (protein, microalbumin, and creatinine). They also tested the blood samples for analytes related to diabetes, liver and kidney function, cholesterol, and anemia. After concluding the testing, they returned the test results to Westat, which then prepared and mailed reports of findings to participants and prepared a final data file for NCHS.</p></div><div id="sr02-210.s13"><h3>NHIS FHS Sample</h3><p>The NHIS FHS initial sample included all NHIS housing units in selected primary sampling units (PSUs) in nine states in June–September of 2021. The nine states spanned two Census regional offices and included both rural and urban PSUs. The NHIS FHS sample was a purposeful sample based on the location of the FRs and ExamOne’s phlebotomists. All Sample Adults in households selected for NHIS FHS who completed the Sample Adult interview in English and for themselves were eligible. Resources for the pilot study did not allow for inclusion of respondents who did not speak English or whose physical or mental condition prevented them from responding directly.</p><p>NCHS’s intention was to include enough households in the initial sample to ensure that ultimately at least 900 Sample Adults would agree to be contacted to schedule an appointment. This was the number of households given in the “Statement of Work” in the “Request for Quotation” issued by the Centers for Disease Control and Prevention, through which NCHS hired Westat, and what Westat used to plan their staffing. The PSUs selected for NHIS FHS contained 3,057 housing units. Budget and geographical constraints were the key drivers of this initial sample size. This starting sample of 3,057 households yielded 1,148 Sample Adults who met the eligibility criteria: they completed the Sample Adult interview in English for themselves. These 1,148 were asked about NHIS FHS. The percentage and number of those 1,148 Sample Adults who agreed to be contacted to schedule an appointment is presented in “Results.”</p></div><div id="sr02-210.s14"><h3>Invitation to Study and Collection of Permission to Be Contacted</h3><p>At the end of the NHIS Sample Adult interview, FRs informed eligible Sample Adults about NHIS FHS. The FR read the script from the NHIS instrument screen (<a href="/books/n/sr02210/sr02-210.app1/?report=reader">Appendix I</a>), which was programmed to display the text about NHIS FHS only if the Sample Adult met all the eligibility criteria. This script explained the goal of the study, what participants would be asked to do, and that after completing the home examination participants would receive their test results and $75. The $75 incentive was provided as a prepaid Visa gift card. The amount on the card was selected to roughly correspond with the incentive offered in a 2018 NHANES follow-back study. That study was somewhat similar in scope to NHIS FHS but also differed in many key ways. See “Feasibility of Implementing Protocols With Full NHIS Sample.” The script explicitly stated, “The Census Bureau does not have a role in this study.” The FR then read a question asking for permission to pass the Sample Adult’s contact information to the contractor: “ExamOne, a Quest Diagnostics company, is collecting the study data for NCHS. May NCHS provide them with your name, age, and gender, along with your address and phone number so they may contact you to schedule an appointment?” The name of the contractor was included so the Sample Adult would understand why that company was calling when it appeared on their phone’s caller ID screen. If the Sample Adult agreed and provided a phone number, the FR then asked what days and time of day they preferred to be contacted and were then asked for permission to be contacted with text messages or e-mails. This information was then passed on to Westat.</p><p>If the Sample Adult refused the request or refused to provide a phone number, the FR asked for their main reason for not wanting to participate. Shortly after the FR left the home, they completed the section of the NHIS instrument designed to collect paradata about the interview. For the NHIS FHS, two additional questions were added to that section (<a href="/books/n/sr02210/sr02-210.app2/?report=reader">Appendix II</a>). Specifically, the FR first entered whether or not they gave the Sample Adult a copy of the study brochure. If the Sample Adult refused to participate and refused to explain why, the FR was asked to enter their impression of the Sample Adult’s reasons for refusing. If the Sample Adult agreed to participate and gave a valid phone number, the FR was asked to enter the reasons the Sample Adult gave, if any, for agreeing to be contacted by a study scheduler. Coding the Sample Adult’s verbatim responses to the question about their reason for refusing occurred in stages. After the first weeks of data collection were completed, NCHS staff reviewed the verbatim responses and created an initial list of refusal categories. Responses were then routinely coded into those categories during the remainder of the field period in which FRs read these questions. Two coders separately coded all the responses then compared their results and resolved any differences. Also during this coding process, the coders would occasionally add a new category when needed. After the initial coding was completed, reason-for-refusal categories were collapsed to form nine major categories.</p><p>Coding the FRs' responses to the question about the reason the Sample Adult refused also occurred in stages and followed the same pattern. Two NCHS staff members coded these answers, compared their results, and resolved any differences. After the initial coding was completed, reason for agreement categories were collapsed to form seven major categories.</p><div id="sr02-210.s15"><h4>Case data transfer</h4><p>NHIS FRs were trained to transmit all completed cases to the U.S. Census Bureau at the end of each workday. When the FR transmitted the completed case, the NHIS FHS information was transmitted with the rest of that case’s NHIS responses. Each Monday, Census staff created a file including only the NHIS FHS-relevant data and sent that file to NCHS staff. NCHS created a subset of that data file, including only age, sex, and contact information for NHIS FHS Sample Adults and sent that file to Westat each Monday or Tuesday. Within 24 hours of receipt, Westat uploaded the information to the study’s secure computer system so ExamOne could then begin scheduling those appointments. NCHS was required to be the intermediary; Census staff could not pass the Sample Adult’s information directly to Westat because the U.S. Census Bureau and Westat did not have an agreement or contract with each other. This restriction affected scheduling operations, which are discussed in “Appointment Scheduling Delays” and “Participant Suggestions for Improving Appointment Scheduling Procedures.” All files were passed using secure methods. NCHS did not provide any Sample Adult health data to the contractors.</p></div></div><div id="sr02-210.s16"><h3>Study Materials</h3><div id="sr02-210.s17"><h4>NHIS FHS initial brochure</h4><p>NCHS created a study brochure in collaboration with the U.S. Census Bureau (<a href="/books/n/sr02210/sr02-210.app3/?report=reader">Appendix III</a>). The study brochure described reasons why the Sample Adult might want to participate, safety measures and privacy protections, what to expect as a participant, and what participants would receive, including a list of the laboratory measures and health tests included in the results report. The study brochure emphasized that the study appointment would be scheduled at a convenient time for the participant. It included a toll-free number, answered by NHIS FHS study staff at NCHS, with an invitation to call for more information about the study. If the interview was in person, the FR offered the Sample Adult a copy of the study brochure when reading the NHIS FHS script. If the interview was conducted over the phone, the FR mailed the brochure to the Sample Adult in a stamped envelope provided by NCHS after the interview was completed.</p></div><div id="sr02-210.s18"><h4>NHIS FHS “why participate” brochure</h4><p>NCHS also created a second study brochure in collaboration with the U.S. Census Bureau (<a href="/books/n/sr02210/sr02-210.app4/?report=reader">Appendix IV</a>) to convince reluctant Sample Adults to participate. In contrast with the initial brochure, the “why participate” brochure had more pictures, less text, and included a full-page spread with brief reasons for participating. Because this brochure was sent after the Sample Adult’s contact information had been loaded into the NHIS FHS system, this brochure included the ExamOne scheduling phone number instead of the NCHS number.</p></div><div id="sr02-210.s19"><h4>NHIS advance letter</h4><p>The NHIS advance letter (available from: <a href="https://ftp.cdc.gov/pub/Health_Statistics/NCHS/Survey_Questionnaires/NHIS/2021/advance-letter-2021.pdf" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">https://ftp.cdc.gov/pub/Health_Statistics/NCHS/Survey_Questionnaires/NHIS/2021/advance-letter-2021.pdf</a>) mailed to respondents ahead of the FR’s first home visit was not modified for NHIS FHS respondents, primarily to avoid influencing the household’s decision to participate in NHIS. Additionally, it was not possible to know in advance if the Sample Adult’s interview in a selected household would be conducted in English and not through a proxy, which were eligibility requirements. Although it would have been possible to create an NHIS–FHS version of the NHIS advance letter for the FRs to give to the Sample Adult during the introduction, the NHIS FHS initial brochure was considered sufficient.</p></div></div><div id="sr02-210.s20"><h3>Scheduling Protocol</h3><p>ExamOne scheduling staff attempted to contact Sample Adults following a scripted, study-specific protocol in which the next step was determined by the Sample Adult’s response or lack of response (<a href="/books/n/sr02210/sr02-210.app5/?report=reader">Appendixes V–VII</a>). The ExamOne scheduler recorded the results of each contact attempt in the system. If the scheduler reached a willing Sample Adult, the scheduler screened the participant for COVID-19 (<a href="/books/n/sr02210/sr02-210.app6/?report=reader">Appendix VI</a>) and, if the participant passed, the scheduler attempted to schedule the appointment. If a study-trained ExamOne phlebotomist was available when the Sample Adult was available, the scheduler scheduled the appointment. If ExamOne schedulers could not reach the Sample Adult, or reached the Sample Adult but they initially gave a soft refusal (refused in a manner that indicated, in the scheduler’s judgement, that the Sample Adult could potentially be converted), then Westat sent a letter encouraging them to call the scheduling number (<a href="/books/n/sr02210/sr02-210.app7/?report=reader">Appendix VII</a>) and two study brochures (<a href="/books/n/sr02210/sr02-210.app3/?report=reader">Appendixes III and IV</a>) via FedEx. The language in the letter for noncontacts differed appropriately from the language in the letter for refusals. Westat recruitment specialists attempted to contact and gain the cooperation of the Sample Adults who did not respond to the refusal letter. When successful, they brought an ExamOne scheduler into the call to complete the rest of the steps for scheduling the appointment. If the scheduler spoke to the Sample Adult and the Sample Adult did not refuse but also did not schedule an appointment, no phlebotomist was yet available at a convenient time for the Sample Adult, or an appointment needed to be rescheduled, the case was returned to the schedulers so they could try calling again in the next call cycle. When the Sample Adult gave a hard refusal, which meant refusing in a way the scheduler judged to be hostile or final, whether before or after scheduling an appointment, the case was given a final outcome code of refused.</p><div id="sr02-210.s21"><h4>Phone calls</h4><p>The ExamOne schedulers were authorized to schedule the home visits immediately after Westat uploaded Sample Adult information to the system. They were expected to schedule as soon as possible and required to do so no more than 24 hours after the case was loaded into the system. However, the time between the Sample Adult agreeing to be contacted and the scheduler placing the first phone call could be as much as a week and sometimes longer, if the FR was delayed in transmitting the case. The schedulers placed calls and were available to answer incoming calls Monday through Friday, 8:00 a.m.–9:00 p.m. CT; Saturday, 9:00 a.m.–6:00 p.m. CT; and Sunday, 1:00 p.m.–6:00 p.m. CT. The schedulers recorded the results of each contact attempt and received phone call, including any reasons the Sample Adult gave for refusing or agreeing to participate, using the web application that connected to the NHIS FHS scheduling system. The schedulers made calls following the study’s recruitment protocol, which included using scripts (<a href="/books/n/sr02210/sr02-210.app5/?report=reader">Appendixes V–VII</a>) for all contacts with the potential study participants to ensure consistency and compliance with the study protocol.</p><p>If the scheduler could not reach a willing Sample Adult in the initial call, schedulers made up to two more phone attempts over 5 days to schedule the appointment. They took the respondents’ preferred contact days and times into account when making subsequent calls, although this was not always feasible depending on when the 5-day call window was set to close. The scheduler left a message if they reached a voice mailbox or answering machine (<a href="/books/n/sr02210/sr02-210.app5/?report=reader">Appendix V</a>).</p><p>If the scheduler reached the Sample Adult and they gave a soft refusal (refused in a manner that indicated, in the scheduler’s judgment, that the Sample Adult could potentially be converted), Westat sent that Sample Adult a refusal mailing; see "Follow-up mailings.” If the scheduler reached the Sample Adult and they gave a hard refusal (a refusal that sounded firm or hostile in the judgement of the scheduler), that case was closed out with a final outcome code of “refused,” and no further refusal conversion efforts were made.</p></div><div id="sr02-210.s22"><h4>COVID-19 screening and setting appointment</h4><p>If the scheduler reached a willing Sample Adult, the scheduler screened the participant for COVID-19 symptoms (<a href="/books/n/sr02210/sr02-210.app6/?report=reader">Appendix VI</a>) to determine when an appointment could be scheduled. The screener included a slightly modified version of the COVID-19 screening questions recommended by the Centers for Disease Control and Prevention when the pilot package amendment was submitted to the NCHS Ethics Review Board (ERB) the first time. The questions were edited for clarity and brevity. If the study participant answered “yes” to any of the screening questions, the scheduler made an appointment for at least 2 weeks into the future. Otherwise, the scheduler made the appointment for the earliest possible date that was both convenient for the participant and on which an ExamOne study-trained phlebotomist was available. To identify such a date, the scheduler used ExamOne’s established protocol for assigning phlebotomists. Specifically, to identify an available health representative, the scheduler consulted the ExamOne portal and calendar where the ExamOne phlebotomists documented their availability for all ExamOne studies they work on. There was no interaction between the calendar that ExamOne maintained and the NHIS FHS systems, and, as stated previously, Westat staff were unable to access this system.</p><p>Phlebotomists usually, but not always, kept their information current, so schedulers were sometimes unaware when their availability changed. ExamOne’s requirement that their schedulers—and only their schedulers—use this restricted-access system for viewing and scheduling phlebotomists, and calendar inaccuracies of phlebotomist availability, impacted operations (see “Difficulty Finding an Available Health Representative”) and may have impacted participation (see “Inability of Recruitment Specialists to Schedule Appointments” and “Participant Suggestions for Improving Appointment Scheduling Procedures”). After identifying a mutually agreeable date and time and scheduling the appointment in the NHIS FHS system, the scheduler then provided the Sample Adult with instructions about how to prepare for the home visit (<a href="/books/n/sr02210/sr02-210.app7/?report=reader">Appendix VII</a>). This included information noting that some of the laboratory tests would be more accurate if the participant did not eat for 8 hours before the appointment, but that the Sample Adult could still participate no matter when they last ate.</p><p>Although the participant’s home was the recommended location for the examination, the participant could request a different location, such as their porch or workplace. Ultimately, the health representative and participant had to agree on the location.</p></div><div id="sr02-210.s23"><h4>E-mails and text messages</h4><p>If the scheduler did not speak to the Sample Adult, the system sent the Sample Adult a text message, e-mail, both, or neither (<a href="/books/n/sr02210/sr02-210.app5/?report=reader">Appendix V</a>), as determined by which permissions the Sample Adult had given when asked by the FR in the introduction to the study at the end of the Sample Adult NHIS interview. The e-mail and text message asked the respondent to call ExamOne’s toll-free number to schedule the appointment. The system sent these automated messages up to two times, each immediately after the scheduler documented the unsuccessful phone contact in the system.</p></div><div id="sr02-210.s24"><h4>Follow-up mailings</h4><p>After the ExamOne scheduler made three phone call contact attempts within the 5-day call window, if none of those attempts resulted in speaking with the Sample Adult, Westat staff sent the respondent a noncontact letter (<a href="/books/n/sr02210/sr02-210.app8/?report=reader">Appendix VIII</a>) via FedEx encouraging them to participate, with instructions about calling the toll-free number to make the appointment. If during that 5-day call window a respondent gave a soft refusal, Westat staff sent the respondent a refusal letter (<a href="/books/n/sr02210/sr02-210.app8/?report=reader">Appendix VIII</a>) via FedEx acknowledging their reluctance and encouraging them to reconsider. Both the noncontact and refusal mailings included a copy of the study brochure used during the initial contact (<a href="/books/n/sr02210/sr02-210.app3/?report=reader">Appendix III</a>) and a separate brochure (<a href="/books/n/sr02210/sr02-210.app4/?report=reader">Appendix IV</a>) listing reasons why some might choose to participate. Cases were eligible to receive only one letter—either the noncontact or refusal letter. If the scheduler successfully contacted the participant during the initial call cycle and the participant did not refuse (that is, neither mailing was sent) but also did not schedule an appointment, the case was returned to the schedulers for another call cycle and was eligible to receive a mailing during that subsequent call cycle. Westat staff reviewed cases in the NHIS FHS system each weekday to identify those that needed a follow-up letter and sent the appropriate material the same day.</p></div><div id="sr02-210.s25"><h4>Refusal conversion calls</h4><p>Westat recruitment specialists began calling potential participants who had given soft refusals 2 days after the refusal mailing was sent, if the Sample Adult had not called ExamOne by that time, to schedule the examination or conduct refusal conversion efforts as needed. The recruitment specialists called up to two times in a 3-day period. Before making calls, they reviewed the participant’s preferred contact days and times and previous contact history to determine when to call. No further attempts were made if the recruitment specialists were unable to reach the Sample Adult after two attempts or the Sample Adult declined to participate. If a recruitment specialist reached a Sample Adult who was willing to schedule a visit, they called an ExamOne scheduler who could schedule the actual appointment. Recruitment specialists, like the schedulers, documented the results of each call in the system as well as any reasons given by the Sample Adult for agreeing or refusing.</p></div><div id="sr02-210.s26"><h4>Timing of scheduling protocol stages</h4><p>As noted previously in “Case Data Transfer,” NCHS typically provided Westat with the weekly file of respondents who agreed to be contacted on Monday or Tuesday, and Westat released the cases for the schedulers to begin making calls the day the file was received or the following day. This flow meant that the 5-day call window for the batch of released cases ended on the weekend. On the following Monday, Westat identified cases without a scheduled appointment from the previous week’s batch of cases that should receive the noncontact mailing. Westat prepared and sent the follow-up packages on Monday or Tuesday, with the call window for the Westat recruitment specialists starting on Wednesday or Thursday and ending on Saturday or Sunday.</p></div><div id="sr02-210.s27"><h4>Extra call cycles</h4><p>Cases were returned to the schedulers for another cycle of calls for the following reasons: (<a href="/books/n/sr02210/sr02-210.rl1/?report=reader#sr02-210.r1">1</a>) the Sample Adult asked to be called back within a specific time frame, (<a href="/books/n/sr02210/sr02-210.rl1/?report=reader#sr02-210.r2">2</a>) the scheduler had spoken with the Sample Adult previously and was actively working to identify an appointment date and time that worked for both the health representative and Sample Adult, and (<a href="/books/n/sr02210/sr02-210.rl1/?report=reader#sr02-210.r3">3</a>) the Sample Adult answered “yes” to one of the COVID-19 screening questions (<a href="/books/n/sr02210/sr02-210.app6/?report=reader">Appendix VI</a>) and was flagged for another cycle of calls 2 weeks later. In some instances, ExamOne supervisors and Westat managers placed cases on hold before returning them to the scheduler for another cycle of calls. They did this when, for example, the Sample Adult was out of town for an extended period and requested a callback weeks later, or ExamOne needed to arrange for a health representative to travel outside of their assigned location to conduct the study visit.</p></div><div id="sr02-210.s28"><h4>Appointment reminder and rescheduling appointments</h4><p>Three days before the scheduled visit, the ExamOne supervisor sent a reminder to the assigned health representatives to remind the participant of the appointment using the participant’s preferred contact mode: e-mail, phone, or text message. One or 2 days before the appointment, the health representative e-mailed, called, or text messaged, as requested, to provide an appointment reminder (<a href="/books/n/sr02210/sr02-210.app9/?report=reader">Appendix IX</a>). Midway through the field period, health representatives requested to use phone reminders because they could administer the COVID-19 screening questions if they reached the participant. In mid-August, the reminder protocol changed to Sample Adult-preferred mode, followed by a phone call.</p><p>The appointment reminder also included the information about fasting. If the health representative was able to reach the participant by phone, they answered any questions the participant had and readministered the COVID-19 screener. If the participant did not pass the screening, the visit was rescheduled at least 14 days into the future.</p><p>The visit could also be rescheduled if the participant requested it. If the participant and health representative knew their availability and were able to agree on a date and time for the rescheduled appointment, the health representative rescheduled the home visit immediately. Otherwise, the schedulers would call later to reschedule. If the health representative could not reach the respondent, they left a message if possible and still visited the home at the appointed date and time.</p></div></div><div id="sr02-210.s29"><h3>Home Visit COVID-19 Safety Protocol</h3><p>Health representatives used a four-step COVID safety protocol on the day of each home examination appointment. First, they completed a COVID-19 self-assessment each workday, using the same screening questions asked of study participants (<a href="/books/n/sr02210/sr02-210.app6/?report=reader">Appendix VI</a>). If the health representatives did not pass, they could not work that day and the visit was rescheduled. Second, they wore wear full personal protective equipment, including a face shield, surgical mask, laboratory coat or long sleeves under scrubs, gloves, and closed-toe shoes before approaching the participant’s home. This was for their safety and the safety of study participants. Third, they screened the participant for COVID-19 before entering the home to conduct the examination (<a href="/books/n/sr02210/sr02-210.app6/?report=reader">Appendix VI</a>). If the participant did not pass the screening, the visit was rescheduled as described in the previous section. Fourth, the health representative covered the signature pad used to obtain informed consent with a sheet of clear barrier film before each participant signed. The participants signed using an individually wrapped, single-use, disposable wooden stylus.</p><p>ExamOne reported no known instances of the health representatives contracting COVID-19 from a study participant, or of study participants contracting the illness from a health representative.</p></div><div id="sr02-210.s30"><h3>Biospecimen Collection Kits</h3><p>Westat developed a collection kit specific to the needs of this study in collaboration with ExamOne and Quest Diagnostics (<a href="/books/n/sr02210/sr02-210.app10/?report=reader">Appendix X</a>). The kits included the consent documents, COVID-19 safety supplies, the prepaid Visa gift card, a blank initial report of findings, and all supplies needed to safely collect, label, package, and ship the blood and urine samples, including the laboratory requisition form. The COVID-19 safety supplies included surgical face masks, hand sanitizer, and sanitizing wipes.</p><p>Each participant was assigned a single four-digit identifier, which was preprinted on labels included in the kit. The health representative attached these labels to the biospecimen containers and to the laboratory requisition form. The health representative also entered this identifier into the instrument during the checkout phase of the home examination protocol. Westat worked with Quest Diagnostics to create and print the laboratory test requisition forms, which only listed the study-specific blood and urine tests.</p><p>The shipping supplies included the boxes used to send the samples via FedEx, with all 13 required International Air Transport Association markings and a shipping label to eliminate errors by the health representatives. Westat assembled the kits before the start of data collection, in time for the health representative training.</p><p>Westat and ExamOne also developed a system to provide kits to health representatives as needed, to ensure a sufficient supply chain. Each health representative received three kits before the start of biospecimen collection. One kit was for training, and two were for use with participants. As cases were assigned to health representatives, they informed the ExamOne scheduler of the number of kits they needed. An ExamOne manager provided a consolidated list to Westat at regular intervals, and the Westat warehouse sent the resupplied kits to the health representatives through overnight shipping. The warehouse staff also provided tracking information to ExamOne.</p></div><div id="sr02-210.s31"><h3>Anthropometric and Blood Pressure Equipment</h3><p>In addition to the kit, the health representatives carried a digital scale to measure weight; a hard tape measure, straight-edge ruler, and sticky note to measure height; and a soft tape measure to measure waist circumference. They also carried a sphygmomanometer, regular and large blood pressure cuffs, and a stethoscope to measure blood pressure. This equipment was provided by ExamOne. The next section and <a href="/books/n/sr02210/sr02-210.app11/?report=reader">Appendix XI</a> explain how this equipment was used.</p></div><div id="sr02-210.s32"><h3>Home Examination Protocol</h3><div id="sr02-210.s33"><h4>Protocol summary</h4><p>If the participant passed the COVID-19 screening, the health representative began the home examination protocols. These were approved by the NCHS ERB, as described in the following section, and were similar to life insurance examination protocols (<a href="/books/n/sr02210/sr02-210.app11/?report=reader">Appendix XI</a>). The protocols included obtaining informed consent (<a href="/books/n/sr02210/sr02-210.app12/?report=reader">Appendix XII</a>), collecting body measurements and biospecimen samples (<a href="/books/n/sr02210/sr02-210.app13/?report=reader">Appendix XIII</a>), administering a survey about the participant’s study experience (<a href="/books/n/sr02210/sr02-210.app14/?report=reader">Appendix XIV</a>), entering the examination and survey data into the instrument on their laptops, attaching the participant’s specific 4-digit specimen identifier labels to the biospecimen containers, providing the participant with a paper copy of their initial results and the $75 prepaid Visa gift card, and entering the Visa card proxy ID into the laptop. Taking body measurements and biospecimen samples consisted of measuring the participant’s height, weight, waist circumference, and blood pressure; collecting a urine sample; and collecting a venous blood sample. To complete this protocol, the health representative used the biospecimen collection kit and anthropometric and blood pressure equipment described in the previous section. The following sections provide more detail on the protocol components.</p></div><div id="sr02-210.s34"><h4>Informed consent</h4><p>To obtain informed consent, the health representative gave the participant a hard copy of the informed consent form and the Measurement and Laboratory Test Explanation handout (<a href="/books/n/sr02210/sr02-210.app12/?report=reader">Appendixes XII and XIII</a>) and asked the participant to read them. Then they asked the participant to sign their name on an electronic signature pad that was attached to the health representative’s laptop, to document their consent.</p></div><div id="sr02-210.s35"><h4>Urine collection</h4><p>To collect the urine, the health representative provided the participant with a sterile 4-ounce collection cup and instructions for collecting about 20 mL of urine in the cup. After the participant returned the urine cup, the health representative transferred a portion of urine from the sterile cup into two transport vessels and labeled all three containers with unique specimen IDs using preprinted labels provided by Westat. After dividing the sample, the sterile collection cup contained enough urine for the urine hemoglobin test. One of the transport vessels contained about 10 mL of urine for total protein, microalbumin, and creatinine testing. The second vessel contained about 10 mL for urine glucose testing. These methods were designated by Quest Diagnostics; see “Biospecimen Processing and Testing.”</p></div><div id="sr02-210.s36"><h4>Anthropometry, blood pressure, and pulse</h4><p>Before measuring the participant’s height, weight, and waist circumference, the health representative asked the participant to remove their shoes and any heavy outer clothing. Height was measured in inches using a steel measuring tape, sticky note, and straight edge. Complete details of how the health representative used the equipment to measure height are provided in <a href="/books/n/sr02210/sr02-210.app11/?report=reader">Appendix XI</a>. Weight was measured in pounds using a digital scale placed on a hard surface. Waist circumference was measured at the umbilicus, with the abdomen relaxed and the soft measuring tape at the same level front and back. Weight and waist measurements were not collected from pregnant women.</p><p>The health representative used a sphygmomanometer and stethoscope to take three blood pressure readings (systolic and diastolic) at 30-second intervals on the same arm after an initial 5-minute rest period. During the rest period, the participant sat with their back supported and legs uncrossed and was asked to remain still and not talk. The health representative took a single pulse measurement manually at the participant’s wrist.</p></div><div id="sr02-210.s37"><h4>Blood collection</h4><p>The health representative collected the venous blood into two 10 mL serum separator tubes and one lavender tube using a 21-gauge butterfly needle and following standard phlebotomy protocols. The health representative labeled all three tubes with unique specimen IDs using preprinted labels provided by Westat. Blood was not collected if the participant had hemophilia or had received cancer chemotherapy in the past 4 weeks. After collecting the blood, the health representative mixed it by gently inverting the tubes 8 to 10 times, which is standard laboratory practice and ensures the blood is thoroughly mixed with any of the additives in the tubes.</p><p>The health representatives centrifuged the serum separator tubes using Quest Diagnostics protocols within an hour after leaving the home. Centrifuging the samples separates the whole blood into its individual components, red blood cells, and serum. This is necessary when only red cells, serum, or plasma is required for testing, or if certain biological processes will affect the results, such as red blood cells using the glucose when in the collection tube. For the blood glucose testing in this study, the serum was tested, and separating the serum from the red cells within 1 hour of collection was a priority for accurate results. Only the hemoglobin and hemoglobin A1c tests used whole blood. The other tests required serum for testing.</p></div><div id="sr02-210.s38"><h4>Visit checkout and post-examination survey</h4><p>After collecting the venous blood, the health representative administered a survey about the participant’s study experience (<a href="/books/n/sr02210/sr02-210.app14/?report=reader">Appendix XIV</a>). This survey included questions about how easy or difficult it was to complete various steps of the process, ideas for improving the process, concerns about participating, and reasons for participating.</p><p>As the health representatives completed the protocol, they entered the examination data, paradata, post-examination survey data, and unique 4-digit specimen identifier into the instrument on their laptops. The examination instrument on the laptop displayed limited on-screen reminders about the protocol, primarily data entry instructions on the correct unit or format (for example, enter height in inches to the nearest half-inch; enter time as HH:MM a.m. or p.m.; if the participant says 12 “midnight,” code as 12:00 a.m.). Additionally, for some items the instrument displayed an error message if the health representative entered an unusual or invalid entry.</p><p>After administering the post-examination survey, the health representative completed and provided the participant with the preliminary report, along with the prepaid Visa gift card and instructions for using the card before leaving the home. An example paper report showing participant height, weight, waist circumference, blood pressure, and resting heart rate is shown in <a href="/books/n/sr02210/sr02-210.app15/?report=reader">Appendix XV</a>. Participants received the prepaid card if they completed at least one of the following components: urine collection, anthropometry, blood pressure measurement, or blood draw. At the end of that day, the health representative logged into the secure VPN within the NHANES IT security authorization boundary and transmitted the results of the examination.</p></div></div><div id="sr02-210.s39"><h3>Packaging and Shipping Biospecimens</h3><p>After leaving the home, and within 1 hour of collection, the health representative centrifuged the serum venous blood tubes to separate the red blood cells from the serum in the blood.</p><p>The health representative also completed the Quest Diagnostics laboratory sample requisition forms for the blood and urine samples, including entering the participant’s unique 4-digit identifier. By recording the sample identification number from the labels on the tubes and vessels in both the instrument on the secure laptop and the laboratory requisition form, Westat was able to match each set of laboratory results to the correct participant when the results were transmitted from Quest Diagnostics, while protecting the actual identity of the participant. Westat maintained the link between the specimen ID and the study participant’s data within a secure IT environment hosted at Westat to ensure Quest Diagnostics did not have any of the participant’s personally identifiable information.</p><p>To help ensure the samples arrived at the laboratory in time and at the correct temperature for all planned tests, the samples were shipped via FedEx overnight to the Quest Diagnostics laboratory in Lenexa, Kansas, on the day of collection. This was necessary because the stability window of the urine sample in the tube for glucose testing was 72 hours after collection, while the stability window of the blood sample for blood hemoglobin testing was only 48 hours after collection. The overnight shipping also helped ensure that the urine sample in the sterile urine cup, which was packaged with two gel ice packs at the bottom of the transport container, remained at 2–8 degrees Celsius so it could be tested for urine hemoglobin. The health representative added absorbent material on top of the ice packs, and then the remaining biospecimens: the two centrifuged serum separator tubes, the lavender blood tube, and the urine vessels. After closing the lid and putting both the transport container and the laboratory requisition form in a cardboard container, the health representative added appropriate labels and dropped off the box at a FedEx shipping center or an authorized FedEx drop-off location. In a few cases, health representatives requested a home pickup.</p></div><div id="sr02-210.s40"><h3>Biospecimen Processing and Testing</h3><p>Quest Diagnostics tested the urine sample for creatinine, glucose, hemoglobin, microalbumin, protein, and protein–creatinine ratio. The blood samples were additionally tested for diabetes (hemoglobin A1c and glucose), liver and kidney function (albumin, albumin-to-globulin ratio, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatinine, globulin, glomerular filtration rate [estimated], potassium, protein, and sodium), cholesterol (total cholesterol, total cholesterol-to-HDL ratio, HDL, LDL, non-HDL cholesterol, and triglycerides), and anemia (hemoglobin). See <a href="/books/n/sr02210/sr02-210.app13/?report=reader">Appendix XIII</a> for more information on these tests.</p><p>As previously noted, Quest Diagnostics did not have access to any of the participant’s personally identifiable information. Quest Diagnostics stored the samples for 7 days after processing and then destroyed the samples. The results, stripped of personally identifiable information, were retained by Quest Diagnostics because of regulatory requirements for clinical laboratories. The 1988 CLIA regulations and College of American Pathologists accreditation standards require Quest Diagnostics to keep the results at least 2 years before destruction.</p></div><div id="sr02-210.s41"><h3>Re-collection</h3><p>When the laboratory encountered a problem testing a blood or urine specimen, the participant was notified and given the opportunity to repeat the urine collection or blood draw. Repeat blood draws were limited to collecting only the blood tubes needed to perform the missing tests from the initial collection. If the participant agreed to the re-collection and scheduled an appointment for it, the health representative returned to the participant’s home, completed the relevant protocol, and then labeled, packaged, and shipped the specimens. Westat provided the health representative with written instructions for performing the re-collection, including documenting the specimen ID and FedEx tracking number. Once Westat received the re-collected sample results from Quest Diagnostics, the specimen ID was updated to match the original specimen ID used during the primary collection.</p></div><div id="sr02-210.s42"><h3>Reporting Results to Participant and NCHS</h3><p>All participants received two reports about the results from their examination: a preliminary report of findings and a mailed final report. For the few participants whose blood or urine analysis yielded critical results, NCHS also provided critical laboratory test value reporting. The laboratory test results were delivered weekly to Westat, in batches to NCHS, and at the end of the project, Westat delivered a final data file and report.</p><div id="sr02-210.s43"><h4>Preliminary report of findings</h4><p>At the end of the home visit, the health representative provided the participant with a handwritten report of their height, weight, waist circumference, calculated body mass index, body mass index and waist circumference risk statement, blood pressure, resting heart rate, and blood pressure risk statement. The form used is shown in <a href="/books/n/sr02210/sr02-210.app15/?report=reader">Appendix XV</a>.</p></div><div id="sr02-210.s44"><h4>Critical laboratory test value reporting</h4><p>Westat and NCHS established a process for relaying critical values identified by Quest Diagnostics’s analysis of participant samples to the participant in a timely manner. This process was modeled on the critical value reporting process used by NHANES, which, as explained previously, used the NHANES medical officer as the point of contact. Before data collection began, Westat provided Quest Diagnostics with contact information for a Westat staff member who would serve as the point of contact for all critical values. When Quest Diagnostics identified a critical value, they notified the Westat point of contact immediately after the result was detected, as required by 1988 CLIA regulations. Westat then used the specimen ID of the critical value provided by Quest Diagnostics to identify the participant whose ID was linked in Westat’s secure database to that specimen ID. Westat relayed that participant’s contact information and critical value result to the medical officer within 1 hour of receiving the notification. Then the medical officer attempted to contact the participant. Of the 27 lab tests performed on study participant samples, 6 tests had established critical values: hemoglobin, glucose, calcium, creatinine, potassium, and sodium. Biospecimen analysis yielded at least one critical value for three participants.</p></div><div id="sr02-210.s45"><h4>Weekly laboratory test results delivery, mailed final reports, and final data file delivery</h4><p>Quest Diagnostics sent Westat a weekly data file of the test results from the previous week through Westat’s study-specific secure FTP site. Westat merged these test results with the information from the preliminary report of findings, performed several quality control checks, and then populated the final report template with the results (<a href="/books/n/sr02210/sr02-210.app16/?report=reader">Appendix XVI</a>). The biospecimen test results were reported with reference ranges, as is standard. The reference ranges for a given test result sometimes varied by one or more demographic characteristics. The final report of findings filled in the appropriate reference range, given a particular participant’s age and sex. Westat then reviewed these reports to detect any irregularities in results that would normally get identified by the testing laboratory. Westat mailed reports to participants in weekly batches, typically within 4 weeks of the home visit. Before mailing the reports, Westat provided electronic copies to the medical officer, who was listed in the report as the person participants should call if they had questions about their results.</p><p>After receiving the last test results delivery from Quest Diagnostics, Westat prepared the final data files and documentation for NCHS.</p></div></div><div id="sr02-210.s46"><h3>IT Systems Testing</h3><p>Before the field period began, NCHS conducted end-to-end tests of the NHIS instrument, including the sample eligibility logic, the introduction to the study questions read by the FR to the Sample Adult, and the FR paradata questions. This testing ensured that all and only the correct Sample Adults were read the NHIS FHS questions, their responses to those questions were captured accurately, and the FR’s information about the process of asking and recording answers to those questions was recorded accurately. The U.S. Census Bureau and NCHS collaborated to test the process for sending NCHS the file with only the data from the NHIS FHS section and contact information for all Sample Adults who agreed to be contacted for FHS. NCHS tested the process for transforming this file into a new file that only contained data for Sample Adults who agreed to participate and sending the new file to Westat. Westat tested their procedures for uploading the data into their system but did not fully test that all data were loaded and displayed correctly. The consequences of this lack of testing are discussed in “Preferred Contact Times Not Initially Displaying Correctly.” Westat tested their systems for recording contact attempts and examination results.</p></div><div id="sr02-210.s47"><h3>Quality Assurance</h3><p>All study staff received training on the study procedures, as detailed in “NHIS FHS Staff Training.” NCHS monitored the time FRs spent on the NHIS FHS questions in the NHIS instrument to check whether they were reading the complete text on these screens or speeding through them. Timing was recorded in the instrument during each visit to a question. That information was used to calculate the FR's longest visit and the total amount of time spent on a question across all visits. This was then compared with an expected timing, calculated as the average time it took five members of the study team to read the NHIS FHS questions out loud at a slow pace.</p><p>Westat monitored scheduling and home visit activity and sent daily e-mails to the ExamOne supervisors describing any issues identified, corrective action required, and retraining of field staff.</p><p>In the second month of data collection, Westat learned of and was granted access to Quest Diagnostics’s electronic reporting application, Quanum for Healthcare Professionals. This application allowed Westat to access laboratory results and identify potential sample concerns in near-real time, which enabled faster problem resolution. Westat used this application to monitor processing of the biospecimens for the remainder of the field period.</p><p>After Westat received the weekly laboratory test results data from Quest Diagnostics, Westat performed several quality control checks to identify and correct any errors the ExamOne health representatives made on the hard-copy requisition form and to reconcile the sample IDs in the laboratory data against those recorded in the blood and urine collection instruments. Westat provided NCHS with weekly participation rate reports and updates on problems identified and solutions implemented.</p></div><div id="sr02-210.s48"><h3>NHIS FHS Contractor Staffing</h3><p>Westat and their subcontractor ExamOne assembled the study staff team of schedulers, recruitment specialists, and health representatives. The schedulers attempted to contact Sample Adults, attempted to convince them to participate in the study when they were reluctant to do so, and scheduled appointments. The recruitment specialists attempted to contact and convince the Sample Adults, when needed. The health representatives reminded Sample Adults of their appointments and conducted the home examinations.</p><p>Westat identified two recruitment specialists for the study, both of whom had experience in gaining cooperation for venous blood draws on Westat studies. Both recruitment specialists completed the study training and worked on the pilot study.</p><p>ExamOne used their existing group of seven schedulers to support the pilot study. These schedulers had no known experience in recruiting for other research studies. Seven schedulers completed the study training and passed the competency assessment, and six of them called study participants.</p><p>ExamOne initially recruited 37 certified phlebotomists with insurance examination experience from their existing national network to work as health representatives for the study, and subsequently hired 2 new phlebotomists to ensure coverage in all the geographic locations included in the study. The number of phlebotomists recruited from each location varied depending on the size of the expected NHIS sample in the area and the success of ExamOne’s recruitment efforts. Slightly more than one-half of the phlebotomists recruited for the study had previous experience on other ExamOne research studies, but that experience was clinical and did not include study recruitment. Of the 39 phlebotomists initially identified by ExamOne as pilot study staff, 32 attended training and passed the competency assessment. None of the phlebotomists failed the competency assessment, although three needed additional practice before the ExamOne supervisor signed off on their assessment. Once ExamOne phlebotomists passed the competency assessment, they became eligible to serve as health representatives for NHIS FHS. Ultimately, only 21 health representatives completed home visits, of which 15 had previous experience with other ExamOne research studies.</p><p>Of the 21 health representatives who were assigned and completed at least one home visit, 6 completed two-thirds of all study visits; 8 health representatives each completed three visits or fewer. This uneven distribution of study visits across health representatives was due to a number of factors. Health representatives differed in their availability, the degree to which their availability overlapped with participants’ preferred appointment times, and their physical proximity to Sample Adults willing to make appointments. When possible, ExamOne schedulers assigned the nearest health representative to the visit, so health representatives closer to willing Sample Adults were assigned more visits.</p><p>The number of health representatives hired for the pilot study was based on the expectation that NCHS would send Westat 900 NHIS Sample Adults who agreed to be contacted for the follow-up study, and that a high percentage of those Sample Adults would schedule appointments. When the lower-than-planned pilot recruitment numbers provided them with minimal work, some health representatives left the project early or took another job, because ExamOne phlebotomists were paid only for completed visits. Among those who stayed, some staff had limited availability to work on this project due to other commitments, both personal and work-related.</p></div><div id="sr02-210.s49"><h3>NHIS FHS Staff Training</h3><div id="sr02-210.s50"><h4>FR training I and II</h4><p>In May 2021, just before the field period began, NHIS FRs whose caseload included addresses in the NHIS FHS sample took a computer-based training about the study. The training began with the statement that “The Census Bureau’s only role in the NHIS Follow-up Health Study is to inform Sample Adults about the study, answer general questions, and ask if they are willing to be contacted about this study.” This training then provided an overview of the purpose and methods of the study; a review of the NHIS FHS questions they would ask the respondent and the questions FRs would answer about that Sample Adult’s responses to the NHIS FHS questions; and answers to questions that Sample Adults might ask about the study. These answers to potential Sample Adult questions covered the study’s purpose, U.S. Census Bureau’s role, safety, COVID-19, privacy precautions, what the blood and urine samples would and would not be tested for, staff training, and home visit procedures. This information was also included in the instrument so they were available to FRs in the NHIS FHS section of the instrument. FRs were encouraged to end any answers they gave with a reminder that study staff could provide more information.</p><p>Midway through July 2021, NCHS drafted, and the U.S. Census Bureau distributed, a short training update to the FRs working on the study. This update was distributed as an electronic memo containing a set of talking points FRs could use to respond to each type of reason for refusal. This memo represented a small but significant shift in the U.S. Census Bureau’s position regarding FR’s role in the study: FRs now had permission and encouragement to provide additional information to respondents who initially refused, if those respondents seemed open to conversion. The reasons for this change are discussed in “FR Role Restrictions and Training Delays.” In late August, FRs working on the study also received a follow-up memo that answered questions raised during the FR focus groups, which is described in the next section.</p></div><div id="sr02-210.s51"><h4>Westat and ExamOne staff training and competency assessment</h4><p>Westat led the training for the study schedulers, recruitment specialists, and health representatives in the 2 1/2 weeks immediately preceding Westat’s receipt of the first Sample Adult contact information, from the end of May through the first week of June 2021. Westat supplied all the content and materials and gave the lectures; ExamOne staff assisted during breakout sessions. The health representatives and schedulers received a role-based, 2-day training with their peers, while the recruitment specialists participated in both the scheduler training and a separate hands-on practice session on a third day.</p><p>Although the original plan was to hold the Westat and ExamOne training in person, it was instead conducted virtually as a result of COVID-19 pandemic restrictions, which included no use of conference rooms and no air travel without special permission. Each trainee participated in the training by watching presentations, practicing using the project data entry applications, and interacting during breakout discussion groups using the Westat-configured laptop each trainee received before training. The trainees then used those laptops to collect the data during the field period as well.</p><p>All ExamOne study staff, including schedulers, recruitment specialists, and health representatives, were trained on the core project content. It included the pilot study’s purpose, goals, and basic logistics; methods for gaining cooperation and avoiding refusals; maintaining accurate records of all contacts and contact attempts; screening for COVID-19 and providing pre-examination instructions; and using the components of the project computer applications specific to their assigned tasks. It also included a brief section on strategies for addressing participant questions and concerns and how to document participant concerns and reasons for refusal. In addition to this content, the health representatives’ training also covered all procedures related to the home visit, including making contact, sending reminders, obtaining consent, conducting the home examination, entering the examination data and paradata into the study computer application, and packaging and shipping the biospecimens.</p><p>Thirty-two phlebotomists attended training. To accommodate health representatives based in three different time zones and limit the number of trainees per session, the phlebotomists were split into two groups, and each group had 2 separate days of training. The class sizes were relatively large for an online training of this kind, with each group ranging from 11 to 21 trainees.</p><p>Seven schedulers completed training. To ensure coverage on ExamOne’s scheduling number, which is used by multiple projects, each training module was held twice. This allowed one-half of the schedulers to attend the session while the rest of the schedulers covered the phones. A high trainer-to-trainee ratio allowed trainers to provide targeted assistance if trainees were having difficulty during hands-on practice sessions.</p><p>The two Westat recruitment specialists responsible for the follow-up calls attended the scheduler training and a separate hands-on practice session to learn how to document their contacts with participants who did not respond to the mailing.</p><p>Westat developed separate competency assessments for the schedulers and health representatives. The assessments included a series of scripted scenarios and role plays intended to evaluate trainees’ ability to implement the study protocols, including using the data system. The ExamOne supervisors were responsible for completing individual assessments with each of the health representatives and schedulers and documenting their performance using checklists developed by Westat. In most cases, ExamOne conducted the assessments using a video-calling application available on the project smart phones. Some assessments were conducted using a video conference service, and one in person. All assessments were concluded before Westat received their first set of cases in early June.</p></div></div><div id="sr02-210.s52"><h3>NHIS FHS FR Feedback Collection</h3><p>NCHS collected feedback from FRs with NHIS FHS cases about their experience working on the study at three time points, from successively larger groups of FRs. First, halfway through the 4-month period during which FRs read the NHIS FHS text and questions to Sample Adults, U.S. Census Bureau staff conducted a virtual focus group with four FRs working in each of the two regional offices, for a total of eight FRs. The goals of that focus group were to learn more about Sample Adult privacy concerns; comments about the $75 incentive; differences in challenges between introducing Sample Adults to NHIS FHS over the phone compared with in person; FR efforts, if any, to convince Sample Adults to participate; the impact of the NHIS FHS questions on respondents’ willingness to complete the Sample Child interview; and the helpfulness of the FAQs in the instrument and the NHIS FHS initial brochure.</p><p>Next, in October 2021, after the field work was complete, the U.S. Census Bureau’s Center for Behavioral Science Methods conducted five focus groups about NHIS FHS on behalf of NCHS, three with FRs from one regional office and two with FRs from the other. Participants were recruited to represent diversity in FR experience level and the type of geographic location worked (urban and rural). Each group had between six and nine participants. The goals of these focus groups were 1) to collect FRs’ perceptions of respondent reactions to the NHIS FHS questions, the incentive, and the brochure and 2) to collect FRs' perceptions of respondent concerns regarding participation. NCHS created the guide for moderating the focus groups with input from the U.S. Census Bureau. The full results from those focus groups are available elsewhere (<a href="/books/n/sr02210/sr02-210.rl1/?report=reader#sr02-210.r7">7</a>).</p><p>Finally, over the last 3 weeks of November 2021, the Center for Behavioral Science Methods fielded a web survey to collect FRs’ feedback on the NHIS FHS. All 99 FRs who introduced the study to at least one NHIS FHS-eligible Sample Adult were invited, and 72% (<i>n</i> = 71) responded. The questionnaire included adapted items from the focus group moderator guide and new items based on preliminary results from the focus groups. NCHS revised and approved the final FR web survey instrument. Some of the results from that survey are available elsewhere (<a href="/books/n/sr02210/sr02-210.rl1/?report=reader#sr02-210.r7">7</a>).</p></div><div id="sr02-210.s53"><h3>ERB Clearance</h3><p>The ERB package was submitted in December 2020 and approved by the full NCHS ERB at the end of February 2021 through a full, nonexpedited review. However, the initial project plan called for COVID-19 antibody testing and reporting to the participant, without providing the subcontractor with the Sample Adult’s personally identifiable information. Quest Diagnostics informed Westat in February that it could not complete this requirement. As a result, NCHS dropped the COVID-19 antibody testing from the set of laboratory blood tests. This resulted in changes in the project materials, and the necessity of preparing and submitting an ERB amendment to account for those project changes. This amendment was approved through expedited review by the NCHS ERB in April 2021.</p><p>Additionally, Quest Diagnostics could not provide blood and urine test results without either signed Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization forms from study participants or a waiver of HIPAA authorization. As a result, NCHS drafted a HIPAA waiver request and submitted it to the NCHS ERB, acting in its authorized capacity as a HIPAA privacy board. The NCHS ERB confirmed NCHS’s argument that it would not be possible to conduct the project without the waiver and approved the request through expedited review in early May 2021. Quest Diagnostics approved the waiver in late May 2021, so field work could begin on June 1, 2021.</p></div><div id="sr02-210.s54"><h3>Planning and Operations Timeline</h3><p>NCHS’s planned development phase for this pilot study was extremely short. According to the “Statement of Work” in the “Request For Quotation” issued by CDC, data collection was expected to begin less than 4 months after the kickoff meeting. NCHS awarded the contract to Westat on September 28, 2020, and NCHS and Westat held the kickoff meeting for the study on October 14, 2020. Although the project team worked steadily and intensely through the fall, preparing the ERB package for submission in less than 11 weeks, the project was unavoidably delayed due to a range of factors. These included the COVID-19 pandemic, the initial ERB submission’s ineligibility for expedited review, and two subsequent challenges that delayed the ERB clearance process, which are described previously. Consequently, the NHIS FHS section of the NHIS instrument did not go live until June 1, 2021. FRs continued to introduce Sample Adults to the study through the end of September 2021. The last home examination was completed on October 31, 2021. <a class="figpopup" href="/books/NBK612043/figure/sr02-210.f6/?report=objectonly" target="object" rid-figpopup="figsr02210f6" rid-ob="figobsr02210f6">Figure 1</a> shows the study’s timeline.</p><div class="iconblock whole_rhythm clearfix ten_col fig" id="figsr02210f6" co-legend-rid="figlgndsr02210f6"><a href="/books/NBK612043/figure/sr02-210.f6/?report=objectonly" target="object" title="Figure 1" class="img_link icnblk_img figpopup" rid-figpopup="figsr02210f6" rid-ob="figobsr02210f6"><img class="small-thumb" src="/books/NBK612043/bin/sr02-210f1.gif" src-large="/books/NBK612043/bin/sr02-210f1.jpg" alt="Flowchart showing the timeline of the National Health Interview Survey Follow-up Health Study" /></a><div class="icnblk_cntnt" id="figlgndsr02210f6"><h4 id="sr02-210.f6"><a href="/books/NBK612043/figure/sr02-210.f6/?report=objectonly" target="object" rid-ob="figobsr02210f6">Figure 1</a></h4><p class="float-caption no_bottom_margin">Timeline of National Health Interview Survey Follow-up Health Study NOTE: NHIS is National Health Interview Survey. SOURCE: National Center for Health Statistics, National Health Interview Survey Follow-up Health Survey, 2020–2021.</p></div></div><p>In some ways, the delay in the field period was advantageous. When data collection began in June 2021, COVID-19 case rates were relatively low and remained so through the end of the field period, which ended before the highly transmissible Omicron variant was detected (for more information, see: <a href="https://www.cdc.gov/mmwr/volumes/71/wr/mm7106a4.htm" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">https://www.cdc.gov/mmwr/volumes/71/wr/mm7106a4.htm</a>). Additionally, one-half of the field period occurred during the summer months, which minimized the potential for school-related exposures affecting either the participants’ or health representatives’ children, and consequently their ability to schedule the study visit.</p><p>Ultimately, only 11 appointments were delayed or rescheduled due to COVID-19-related reasons. Nine appointments were delayed due to COVID-19 exposure, symptoms, or illness in either the participant, a participant’s family member, or a health representative’s family member. Two appointments were delayed because the participant wanted to get the COVID-19 vaccine or booster before scheduling the visit. Of these 11 participants, 6 ultimately completed the home examination. The first instance of a participant responding “yes” to the COVID-19 screening questions occurred in early August 2021, around the time that the Delta variant was beginning to impact the United States.</p></div><div id="sr02-210.s55"><h3>COVID-19-period Conditions</h3><p>The period effects on the planning, implementation, and results of this pilot study should not be underestimated, but they cannot be precisely quantified. The timing of the pilot field period within the pandemic impacted all aspects of planning and implementing the study. It also likely impacted the willingness of Sample Adults to participate, although it is impossible to say exactly how much.</p><p>Designing the study and selecting a contractor in the spring and summer of 2020 during the COVID-19 pandemic was challenging. The United States was under a national emergency, several states issued stay-at-home orders and mask mandates, schools were closed, and businesses implemented capacity limits to slow the rate of new infections. During this time, and into the NHIS FHS field period, all NCHS employees were teleworking, NHIS field operations were changed from in-person to telephone, and NHANES stopped data collection. CDC recommended social distancing measures for shared spaces including workplaces. However, other CDC recommendations changed over time as the science evolved, and these recommendations were not always popular. The organization was also frequently competing with misinformation spreading through social media. All of these factors undermined trust in CDC among some segments of the population. During this period, COVID-19 deaths were at their highest so far in the pandemic, and vaccines were not available. Parents whose jobs could not be moved to the home scrambled to find childcare, while those working from home juggled their job responsibilities with supervising and assisting with their children’s distance learning. This stressful time was unprecedented in living memory and had wide-ranging negative impacts on population mental health, even among those who stayed physically healthy (<a href="/books/n/sr02210/sr02-210.rl1/?report=reader#sr02-210.r8">8</a>).</p><p>The situation and the virus kept evolving, with significant developments occurring even within the short 5-month pilot field period. By the time data collection began in June 2021, the situation had improved in some ways, but only recently and incrementally. People age 16 and older had been eligible for Pfizer vaccines and adults age 18 and older had been eligible for Moderna vaccines in every state for at least a month and a half, but the percentage of people age 16 and older who were vaccinated varied across and within states. Children ages 12–15 years had just become eligible for the Pfizer vaccine through an emergency use authorization from the U.S. Food and Drug Administration in May. Many people were still not hosting family and friends inside their homes, let alone strangers. Midway through collection, in late July 2021 amid the Delta variant surge, CDC released updated masking guidance that everyone in areas with substantial or high transmission should wear a mask indoors. By the time data collection concluded at the end of October 2021, many people older than age 16 in the United States had been vaccinated, as well as many children ages 12–15, but the rates differed by race and Hispanic origin. Some schools had returned to in-person instruction, some were implementing hybrid models, and some were still completely virtual. Children younger than age 12 years were still not yet eligible for COVID-19 vaccines.</p><p>These COVID-19-period conditions likely impacted Sample Adults’ cost-benefit analysis of the home visit and their willingness and ability to be contacted, schedule appointments, and keep appointments. The factors that connected the period conditions and these outcomes include fear of infection, pandemic-related exhaustion, and time constraints from pandemic-related daily life alterations. Among some population groups, mediators also likely included increased suspicion of and hostility toward the federal government in general and CDC in particular. These period conditions also impacted the ability of the contractors to hire and train staff and the ability of those staff to plan for and keep appointments.</p></div></div><div id="bk_toc_contnr"></div></div></div><div class="fm-sec"><h2 id="_NBK612043_pubdet_">Publication Details</h2><h3>Copyright</h3><div><div class="half_rhythm">All material appearing in this report is in the public domain and may be reproduced or copied without permission; citation as to source, however, is appreciated.</div></div><h3>Publisher</h3><p><a href="https://www.cdc.gov/nchs/products/series/series02.htm" ref="pagearea=page-banner&targetsite=external&targetcat=link&targettype=publisher">National Center for Health Statistics (NCHS)</a>, Atlanta (GA)</p><h3>NLM Citation</h3><p>Galinsky AM, Medley GE, Nguyen DT, et al. National Health Interview Survey Follow-up Health Study: Feasibility Evaluation of Adding an In-home Physical Examination to a National Health Survey [Internet]. Atlanta (GA): National Center for Health Statistics (NCHS); 2024 Dec. Methods.<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/sr02210/sr2-210ch01/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M75,30 c-80,60 -80,0 0,60 c-30,-60 -30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Prev</text></svg></a></div><div class="small-screen-next"><a href="/books/n/sr02210/sr2-210ch03/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M25,30c80,60 80,0 0,60 c30,-60 30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Next</text></svg></a></div></article><article data-type="fig" id="figobsr02210f6"><div id="sr02-210.f6" class="figure bk_fig"><div class="graphic"><img data-src="/books/NBK612043/bin/sr02-210f1.jpg" alt="Flowchart showing the timeline of the National Health Interview Survey Follow-up Health Study" /></div><h3><span class="label">Figure 1</span></h3><div class="caption"><p>Timeline of National Health Interview Survey Follow-up Health Study</p><p>NOTE: NHIS is National Health Interview Survey. SOURCE: National Center for Health Statistics, National Health Interview Survey Follow-up Health Survey, 2020–2021.</p></div></div></article></div><div id="jr-scripts"><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/libs.min.js"> </script><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.min.js"> </script></div></div>
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