[Federal Register Volume 68, Number 164 (Monday, August 25, 2003)]
[Notices]
[Pages 51017-51018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-21555]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Request for Measures of Patients' Hemodialysis Care Experiences

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Notice of request.

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SUMMARY: The Agency of Healthcare Research and Quality (AHRQ) is 
soliciting the voluntary submission of instruments measuring patient 
perspectives of their experience with hemodialysis facilities from 
researchers, vendors, stakeholders and other interested parties. AHRQ 
and the Centers for Medicare & Medicaid Services (CMS) have set as a 
priority the development of a standardized survey that may be used to 
make widely available, comparable measurements of hemodialysis patient 
experiences. Therefore, AHRQ is assessing the feasibility of creating 
such a standardized instrument and the nature and scope of the work to 
be done. As part of the feasibility study, AHRQ is reviewing existing 
instruments that capture patients' treatment experiences and is 
therefore requesting voluntary submission of such instruments or 
measures along with documentation for administration of the instruments 
or measures and, if possible, critical evaluations of particular 
measures or related survey administration techniques.

DATES: Parties interested in contributing to this endeavor are asked to 
submit the requested material on or before October 24, 2003 to Beth 
Kosiak, Ph.D. (see address below). AHRQ will not reply to individual 
responses, but will consider all submissions and suggestions.

ADDRESSES: Submissions should include a brief cover letter and include 
copy of the instrument or particular measure(s) for consideration. They 
may be in the form of a letter or e-mail, preferably with an electronic 
file in a standard word processing format such as Microsoft Word or 
Word Perfect on a 3\1/2\ inch diskette enclosed or as an e-mail with an 
e-mail attachment. Electronic submissions are strongly encouraged. 
Responses to this request should be submitted to: Beth Kosiak, PhD, 
Agency for Healthcare Research and Quality, 540 Gaither Road, 
Rockville, MD 20850, Phone: (301) 427-1322, Fax: (301) 427-1341, e-
mail: [email protected].
    In order to ease the handling of submissions, please send a copy of 
the instrument or measure(s), and a cover letter addressing the extent 
to which the information submitted meats the ``Submission Criteria'' 
below. A copy or citation of relevant peer-reviewed journal articles is 
also desirable, but not required. For citations, please include the 
title of the article, author(s), publication year, journal name, 
volume, issue, and page numbers where article appears. All submissions 
must include a statement of willingness to grant to AHRQ the right to 
use and authorize others to use submitted measures and their 
documentation as part of a CAHPS[reg]-trademarked instrument. Any CAHPS 
instrument developed for patient perspectives of experiences of 
hemodialysis care will be made publicly available for use free of 
charge. However, a CAHPS instrument bearing the CAHPS trademark may 
only be administered following CAHPS documentation and instructions. To 
facilitate our obtaining any other required clarifications, please 
submit the following information with respect to a knowledgeable 
contact person: (a) Name, (b) title, (c) organization, (d)

[[Page 51018]]

mailing address, (e) telephone number, and (f) e-mail address. For 
clarity, please do not use acronyms without explanation..

FOR FURTHER INFORMATION CONTACT: Beth Kosiak, PhD, from the Center for 
Quality Improvement and Patient Safety, Agency for Healthcare Research 
and Quality (see contact information above).

Submission Criteria

    Measures submitted should ideally reflect these elements to be 
considered: (a) They must capture the patients' perspective on their 
experience of care in hemodialysis settings; (b) have a high degree of 
reliability and validity; and (c) have been used widely, not just in 
one or two research studies or local dialysis settings. It is 
recommended that submitters provide documentation that the 
instrument(s) or measure(s) they submit meets these criteria. The 
following information, if available, should be included in the 
submission of materials: the name of the instrument, domains assessed, 
language(s) in which the instrument is available, evidence of cross 
group/cultural comparability if any, examples of uses of the instrument 
for quality assessment or improvement, scale, psychometric statistics, 
such as individual level reliability (e.g., internal consistency, test-
retest), group level reliability, item response theory (IRT) 
statistics, validity (content, construction, criterion), as well as 
cognitive interviews and field test results, and details about focus 
groups.
    Submitters are also encouraged to submit recommendations regarding, 
and any evaluations of, administration protocols, including recommended 
patient contact procedures, recommended sample sizes, mode of 
administration, any information available about mode effects, and mode 
specific response rates. Evidence of the criteria may be demonstrated 
by providing peer-reviewed journal article(s) or citations thereof.
    As noted above submitters must indicate a willingness to grant to 
AHRQ the right to use and authorize others to use the submitted 
instrument or particular measures or formats therein. The license or 
assignment of rights will make it possible to apply the CAHPS trademark 
to a new instrument combining the best features of all the submissions 
as well as any ideas that may develop from reviewing them. AHRQ will 
not simply adopt one instrument and apply the CAHPS trademark to it. 
Rather, AHRQ, in collaboration with its CAHPS grantees, will evaluate 
all submitted instruments and measures, select several, either in whole 
or in part, for testing, or more likely devise one or more for testing 
and, as required, make additional modifications for the final product. 
AHRQ will assume responsibility for the final measure set as well as 
any further modifications to the developed instruments. Sources used in 
developing the final product will be acknowledged by AHRQ in the 
appropriate forum. In addition, all submissions will be publicly 
reported in aggregate.
    The finalized instrument will bear the CAHPS trademark. As 
indicated above, it will be made freely available for use by all 
interested parties. There will be free access to the instrument's 
supportive/administrative information as well, and as a matter of 
quality control, there will be warnings that the CAHPS identification 
may not be used if any changes are made of the instrument or final 
measure set, without review and permission of the agency. AHRQ will 
assume responsibility for the final measure set as well as any further 
modifications to the developed instrument.

SUPPLEMENTARY INFORMATION: 

Background

    The Agency for Healthcare Research and Quality has been a leading 
proponent and supporter of the development of instruments for measuring 
patient experiences within the healthcare system of the United States. 
Through prior CAHPS patient survey development efforts such as the 
Consumer Assessment of Health Plan CAHPS[reg], AHRQ has been 
able to provide valuable information to consumers and purchasers alike. 
While the Health Plan CAHPS[reg] tool is highly regarded 
within the industry and provides valuable information to consumers and 
purchasers, it does not address hemodialysis patient experiences of 
care.
    Leaders in the healthcare sector have called for a response to this 
pressing need. In ``Crossing the Quality Chasm'', the National 
Institute of Medicine (IOM) established patient-centered care as one of 
the industry's six aims for quality improvement. The dimensions of 
patient-centered care include: Respect for patients' values, 
preferences, and expressed needs; coordination and integration of care; 
information, communication, and education; physical comfort; emotional 
support, i.e., relieving fear and anxiety; involvement of family and 
friends (2001). From past experience, AHRQ suggests the addition of two 
more aims for quality improvement: Continuity and transition; and 
access to care. To measure these dimensions will require a standardized 
instrument that produces reliable and valid results.
    In an effort to address the concerns of the industry, the Director 
AHRQ and the Administrator of CMS have established a priority to 
develop a standardized measure of hemodialysis patients' experiences. 
The goal of developing the standardized survey and reporting quality 
data on hemodialysis facilities could be reached within the next few 
years.
    The steps to advance this initiative include:
    [sbull] Stakeholder and Technical Expert Panel Meetings: A series 
of meetings will be held to identify the issues, concerns and interests 
of the healthcare community. Summaries of these meetings will be posted 
on the AHRQ Website: http://www.ahrq.gov/.
    [sbull] Feasibility Study: The process to access the feasibility of 
developing a national standardized survey instrument to measure patient 
experiences with hemodialysis care. As part of the study, the potential 
uses of the instrument such as quality improvement, public reporting, 
or both will be assessed.
    [sbull] Research Plan: The process by which measures will be 
defined and applicable instruments identified. Instruments submitted 
will be evaluated to determine if they meet the measurement needs and 
to identify whether additional measure development is required. The 
standardized instrument will reside in the public domain.
    [sbull] Implementation Plan: A process to implement the 
standardized survey will be established to include information related 
to data collection, analysis, and reporting.

    Dated: August 14, 2003.
Carolyn M. Clancy,
Director.
[FR Doc. 03-21555 Filed 8-22-03; 8:45 am]
BILLING CODE 4160-90-M