[Federal Register Volume 85, Number 219 (Thursday, November 12, 2020)]
[Notices]
[Pages 71902-71904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24968]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Malnutrition in 
Hospitalized Adults

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

ACTION: Request for supplemental evidence and data submissions.

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review on Malnutrition in 
Hospitalized Adults, which is currently being conducted by the AHRQ's 
Evidence-based Practice Centers (EPC) Program. Access to published and 
unpublished pertinent scientific information will improve the quality 
of this review.

DATES: Submission Deadline on or before December 14, 2020.

ADDRESSES: 
    Email submissions: [email protected].
    Print submissions:
    Mailing Address: Center for Evidence and Practice Improvement, 
Agency for Healthcare Research and Quality, ATTN: EPC SEADs 
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
    Shipping Address (FedEx, UPS, etc.): Center for Evidence and 
Practice Improvement, Agency for Healthcare Research and Quality, ATTN: 
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, 
MD 20857.

FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496 
or Email: [email protected].

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Program to complete a review of the evidence for Malnutrition in 
Hospitalized Adults. AHRQ is conducting this systematic review pursuant 
to Section 902 of the Public Health Service Act, 42 U.S.C. 299a.
    The EPC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on Malnutrition in Hospitalized Adults, including those 
that describe adverse events. The entire research protocol is available 
online at: https://effectivehealthcare.ahrq.gov/products/malnutrition-hospitalized-adults/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Malnutrition in Hospitalized Adults helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this indication. In the list, please indicate whether 
results are available on ClinicalTrials.gov along with the 
ClinicalTrials.gov trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, a summary, including the following elements: Study 
number, study period, design, methodology, indication and diagnosis, 
proper use instructions, inclusion and exclusion criteria, primary and 
secondary outcomes, baseline characteristics, number of patients 
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, 
effectiveness/efficacy, and safety results.
    [ssquf] A list of ongoing studies that your organization has 
sponsored for this indication. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including a study number, the study period, 
design, methodology, indication and diagnosis, proper use instructions, 
inclusion and exclusion criteria, and primary and secondary outcomes.
    [ssquf] Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your organization for 
this indication and an index outlining the relevant information in each 
submitted file.
    Your contribution is very beneficial to the Program. Materials 
submitted must be publicly available or able to be made public. 
Materials that are considered confidential; marketing materials; study 
types not included in the review; or information on indications not 
included in the review cannot be used by the EPC Program. This is a 
voluntary request for information, and all costs for complying with 
this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC Program 
website and available for public comment for a period of 4 weeks. If 
you would like to be notified when the draft is posted, please sign up 
for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.
    The systematic review will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions.

Key Questions (KQs)

    Key Question 1. What is the association between malnutrition and 
clinical outcomes among hospitalized patients?
    a. How do outcomes vary depending on measures or tools used to 
detect malnutrition?
    b. Are patient-related risk factors, such as increased age or 
certain pre-existing health conditions, associated with poorer clinical 
outcomes?

[[Page 71903]]

    Key Question 2. What is the effectiveness of screening or 
diagnostic assessment for malnutrition among hospitalized adults?
    a. In studies that report on clinical outcomes, what is the 
diagnostic accuracy of screening or diagnostic assessment for 
malnutrition?
    b. In studies that report on clinical outcomes, what is the 
effectiveness of screening or diagnostic assessment on measures of 
nutrition (nutritional stores)?
    c. What is the impact of screening or diagnostic assessment on 
clinical outcomes?
    Key Question 3. Among patients diagnosed with malnutrition, what is 
the effectiveness of hospital-initiated interventions used to treat 
malnutrition on clinical outcomes?

 PICOTS (Population, Intervention, Comparator, Outcome, Timing, Setting)
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             Category                            Definition
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Population........................  Key Question 1 and 2: Hospitalized
                                     adults aged 18 years or older (see
                                     Methods section for exceptions).
                                    Key Question 1b subgroups include
                                     adults with no risk of
                                     malnutrition, adults with risk of
                                     malnutrition, and adults with
                                     baseline malnutrition. Risk factors
                                     of interest to this report include:
                                        Older patients (>65
                                        years)
                                        Racial and ethnic
                                        minorities
                                        Low income (e.g.
                                        Medicaid beneficiaries)
                                        Patients with malignancy
                                        Patients with
                                        gastrointestinal disease and
                                        subsequent malabsorption,
                                        including ulcerative colitis and
                                        Crohn's disease
                                        Patients with chronic
                                        liver disease
                                        Patients with stroke
                                        Patients with chronic
                                        kidney disease
                                        Patients with dementia
                                        Patients with critical
                                        illness
                                        Sepsis/infection
                                    Key Question 3: Adults diagnosed
                                     with protein-energy malnutrition.
Interventions/Exposures...........  Key Question 1: Positive screening
                                     for nutrition risk and/or diagnosis
                                     of malnutrition vs no malnutrition.
                                    Key Question 2: Malnutrition
                                     screening and diagnostic assessment
                                     tools (utilized within the U.S.,
                                     Australia, New Zealand, Canada, and
                                     Europe). Examples of tools of
                                     interest include:
                                    Screening:
                                        Malnutrition Screening
                                        Tool (MST)
                                        Malnutrition Universal
                                        Screening Tool (MUST)
                                        Nutritional Risk Index
                                        (NRI)
                                        Nutrition Risk in
                                        Critically Ill (NUTRIC) score
                                    Diagnostic Assessment:
                                        Subjective Global
                                        Assessment (SGA)
                                        Patient Generated
                                        Subjective Global Assessment (PS-
                                        SGA)
                                        Mini Nutritional
                                        Assessment (MNA)
                                        AND (Academy of
                                        Nutrition and Dietetics)-ASPEN
                                        (American Society for Parenteral
                                        and Enteral Nutrition)
                                        Malnutrition Consensus Criteria
                                        (MCC)
                                        Global Leadership
                                        Initiative on Malnutrition
                                        (GLIM)
                                    Key Question 3: Hospital-initiated
                                     malnutrition interventions.
                                     Examples of interventions include:
                                        Parenteral nutrition
                                        Enteral nutrition
                                        Oral nutrition
                                        supplements
                                        Nutrition team
                                        consultation, includes dietitian
                                        counseling
                                        Pharmacologic
                                        interventions
Comparators.......................  Key Question 1: Hospitalized
                                     patients without malnutrition, or
                                     direct comparisons of different
                                     definitions of malnutrition.
                                    Key Questions 2: Radiographic
                                     imaging or SGA will be used as the
                                     reference standard.
                                    Key Question 3: Usual care or
                                     another hospital-initiated
                                     malnutrition-related intervention.
Outcomes..........................  Clinical Outcomes (All Key
                                     Questions):
                                        Mortality (inpatient and
                                        30-day)
                                        Length of stay
                                        30-day readmission
                                        Quality of life
                                        Functional status,
                                        includes gate speed, Karnofsky
                                        Index, handgrip strength, days
                                        on ventilator
                                        Activities of daily
                                        Hospital Acquired
                                        Condition (HAC)
                                        Wound healing
                                        Discharge disposition
                                    Intermediate Outcomes (KQ 2):
                                    Diagnostic accuracy outcomes:
                                        Sensitivity
                                        Specificity
                                        Predictive value
                                        Area under the curve
                                    Intermediate Outcomes (KQ 2 or KQ
                                     3):
                                    Nutrition Stores: Direct measures of
                                     nutrition status (nutrition stores)
                                     during and post hospitalization.
                                     Examples include:
                                        Cross-sectional areas
                                        for lumbar skeletal muscle and
                                        adipose tissue
                                        Skeletal Muscle Index

[[Page 71904]]

 
                                        Regional or total fat
                                        mass and muscle mass assessed
                                        using validated gold standard
                                        methods, such as body
                                        composition measures derived
                                        through Computed Tomography (CT)
                                        scans, Dual X-ray Absorptiometry
                                        (DXA), and Magnetic Resonance
                                        Imaging (MRI)
Timing............................  Up to 30 days post-discharge
Setting...........................  Acute care hospitalizations
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    Dated: November 5, 2020.
Marquita N. Cullom,
Associate Director.
[FR Doc. 2020-24968 Filed 11-10-20; 8:45 am]
BILLING CODE 4160-90-P