6

MINUTES
Observational Study Monitoring Board
Hispanic Community Health Study - Study of Latinos
Meeting, 11/19/2010
PARTICIPANTS:
OSMB Members Present: Anne Newman, George Howard, Hannia Campos, Martha Medrano
OSMB Members Absent: Gustavo Cruz, Judy Dubno, Odilia Bermudez
Investigators: Diane Catellier, Martha Daviglus, Aida Giachello, Gerardo Heiss, Robert
Kaplan, Lisa LaVange, Neil Schneiderman, Krista Perreira, Wayne Rosamond, Daniela SotresAlvarez, Gregory Talavera, Bharat Thyagarajan
Data Coordinating Center Staff: Jeff Oberhaus, Marston Youngblood
NHLBI Staff: Jean Olson, Executive Secretary; Larissa Avilés-Santa; Cheryl Jennings;
Lorraine Silsbee; Paul Sorlie; Elizabeth Zoller. Other NIH Staff: Ligia Artiles (NIMHD), Howard
Hoffman (NIDCD), Nathan Stinson (NIMHD)
INTRODUCTION
The HCHS-SOL is a multi-center longitudinal cohort study of Hispanics in the US initiated in
October 2006 by NHLBI with co-support from 6 other NIH Institutes. The study objectives are to
identify the prevalence of protective and harmful factors for diseases, disorders, and conditions
in Hispanic populations and to determine the role of acculturation and other mediators in their
prevalence and development. A mid-year study report, delivered as requested to the OSMB in
June 2010, addressed the bulk of the recommendations from the OSMB’s November 2009
meeting and was accepted by the Board members via an email consensus.
The morning closed session of this regularly scheduled meeting of the HCHS-SOL OSMB was
called to order at 8:10 a.m. by OSMB Chair Dr. Howard. Executive Secretary Dr. Olson
confirmed that no OSMB members had conflict of interest issues not previously reported and
addressed via the annual NHLBI COI reporting process. The minutes of the previous OSMB
meeting were approved. Project Officer Dr. Avilés-Santa provided an overview of the study’s
present status. The open session, including study investigators, began at 8:50 a.m. with
introductions of those present.
STUDY UPDATE AND PROGRESS REPORT
Now in its final year of a 39-month recruitment, the study has enrolled more than 12,500
participants and is projected to meet its recruitment goals by June 2011 as planned. In addition
to ongoing cohort recruitment, examination and annual follow-up activities, the Field Centers are
dealing with end-of-exam issues such as maintaining staff size and quality as recruiters and
clinic staff begin thinking about future employment. Clinical event ascertainment is underway,
and events adjudication by physician reviewers will begin in Spring 2011. Four ancillary studies
are now active and a fifth will be starting shortly. Junior investigators at all four Field Centers
have received diversity supplement awards.
COORDINATING CENTER REPORT
The recruitment sampling design used in the HCHS-SOL has thus far yielded a cohort with the
intended distributions of age groups and Hispanic heritage. Approximately half of households

selected for invitation to participate in the study have agreed to participate. The Coordinating
Center is monitoring recruitment carefully to close subsamples when study goals are reached
and redirect recruitment efforts to communities with demographics still needed.
Reliability of laboratory and anthropometric measurements is very high overall. The physical
activity monitoring data is an exception, since increasing numbers of participants are not
wearing the activity monitor for the required time. To address this, the Coordinating Center is
giving feedback on this component to the Field Centers, which, in turn, are implementing
strategies to improve participant compliance with instructions for wearing the monitor.
To date, 96% of participants have completed either the nearly 7-hour full exam or the core visit
of highest priority exam components. Consent to provide DNA and RNA has been given by
98% of participants and 97% have agreed to sharing of data with other qualified investigators,
though only 76% have allowed their data to be shared with for-profit companies. Exam results
and alert values are reported in a timely manner in accordance with the study protocol.
The Board asked about the study’s success with phone calls as the primary method of
participant follow-up. Many participants do not have landlines but most do have cell phones;
about half use pre-paid cards, so their phones may only be active intermittently. Other
strategies to reach participants include home visits and the Internet. The study asks each
participant to name contact persons who can give information about the participant’s
whereabouts. Some of these contacts are unreachable; however, those who are contacted are
often unwilling to give such information to study staff. Recent increases in inquiries about
immigration status may be contributing to this, and even legal immigrants may have concerns
about being tracked by government and other entities.
One protocol violation occurred during the year, in which a coding error at the Coordinating
Center led to erroneous reporting of negative hepatitis C tests as positive to 63 participants.
The Coordinating Center corrected the coding error; in addition, the study’s Central Lab updated
its hepatitis C testing algorithm to include a confirmatory recombinant immunoblot assay (RIBA)
to meet current CDC hepatitis C testing guidelines and applied this confirmatory test to all 63
cases of erroneous reporting. The Field Centers reported and explained the updated test
results to those affected. The new hepatitis C testing protocol has been applied retroactively to
all participants.
Deviations from safety protocol exclusions also occurred in the past year, in which some
participants underwent study procedures that were contraindicated for safety reasons. The
study is unaware of any adverse events resulting from these deviations. Staff re-training and
ongoing central monitoring of adherence to the safety protocol were implemented to address
this problem. The Board felt that the periodontal exam, performed on 89 participants with
contraindications, is the one procedure where a resulting adverse event might not have been
immediate. The Board recommended that the study determine whether any delayed adverse
sequelae occurred in this group of participants.
Annual follow-up completion is approximately 82% overall. The effort required to conduct the
annual contacts grows as the cohort grows. An additional challenge is the high transience of
the cohort, over 80% of whom are first generation U.S. residents. The annual follow-up
contacts enable identification of clinical endpoints. SOL collects discharge codes for all
reported hospitalizations and validation of a selected list of codes of interest will begin soon.
The Board noted the study’s high success rate in medical records retrieval, an increasingly
difficult task as hospital-specific proof of authorization requirements increase in complexity.

The HCHS-SOL has submitted ten abstracts for presentation, eight more are in progress, and
two study design and methods papers have been published. Data from the cohort recruited
thus far are being used for abstract preparation and presentations. Manuscripts will utilize data
from the entire cohort when available. The Coordinating Center is preparing guidance for
investigators on appropriate analytic strategies to account for the sampling methodology used in
SOL.
SOL and the OSMB have approved twenty ancillary study proposals so far. Several of these
are funded and underway, and several more are awaiting funding. The SOL Steering
Committee requested the OSMB to reconsider its ruling that participants be enrolled in no more
than two ancillary studies per year. The study has found most participants enjoy the ancillary
studies, the participant burden varies greatly across them, and involvement in ancillary studies
will help the Field Centers retain good clinic staff as the baseline exam winds down.
The open session concluded at 1:45 p.m.
RECOMMENDATIONS
The Board congratulated the investigators on the study’s great success thus far, particularly on
recruitment and early scientific productivity. The Board also appreciated the positive and
thorough manner with which the study addressed and corrected the hepatitis C protocol
violation. There were no issues of serious or immediate concern. The Board made the following
recommendations:
1. Continuation of the study was enthusiastically endorsed.
2. Follow-up should be conducted for possible procedure-related adverse events among
the 89 participants who had the periodontal examination against the safety protocol.
3. The study is complimented for its efforts to address the decreasing rates of the physical
activity assessment component. It is encouraged to redouble its efforts in order to
reverse this trend as soon as possible.
4. Confirming and updating information on persons named by participants as contacts
should be a high priority at every participant follow-up.
5. A proposal is requested from the study for a revised system to manage participant
burden due to participation in ancillary studies. The proposal should include
a. A metric for weighing participant burden vs. benefit to the study
b. A metric for weighing burden and distraction to study investigators and staff
c. An exception clause to ancillary study participation limitations for those ancillary
studies that offer particularly good return to participants
6. While the study is having good success obtaining medical records to identify potential
clinical events, there may be systematic differences between participants for whom
records are and are not obtained. The study is encouraged to investigate this possibility.
7. The investigators are encouraged to think strategically about how near-term scientific
productivity fits into efforts to renew contract funding for the study.
8. Some changes to the very comprehensive OSMB Report are requested
a. Make the report less dense by removing some non-essential detail
b. Include an executive summary (2 pages or less)
c. Consider using metrics and tables that better describe cohort retention. The
Board is most interested to see (1) overall retention status; (2) trends in retention
over time; (3) Field Center-specific retention status and trends; and (4) particular
cohort subgroups in which retention is a problem.
NEXT MEETING
The next meeting is tentatively scheduled for November 2011.

SIGNATURES
Respectfully submitted,

_____________________
George Howard, Ph.D.
Chair, HCHS-SOL OSMB

_____ APPROVAL

________________________
Jean Olson, M.D.
Executive Secretary, HCHS-SOL OSMB

_____ DISAPPROVAL

December 3, 2010
_______________________
Acting Director, NHLBI

Date