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 Department of Health and Human Services Agency for Healthcare Research and Quality
 AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
 ACTION: Request for supplemental evidence and data submission.
 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 
                        *Dietary Total Fat Intake and Dietary Polyunsaturated Fatty Acid Intake and Child Growth and Development Outcomes: A Systematic Review,*
                         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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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 18, 2024.
 ADDRESSES:  *Email submissions: epc@ahrq.hhs.gov.* *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: Kelly Carper, Telephone: 301-427-1656 or Email: 
                        *epc@ahrq.hhs.gov.*


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 
                    *Dietary Total Fat Intake and Dietary Polyunsaturated Fatty Acid Intake and Child Growth and Development Outcomes: A Systematic Review.*
                     AHRQ is conducting this 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 
                    *Dietary Total Fat Intake and Dietary Polyunsaturated Fatty Acid Intake and Child Growth and Development Outcomes: A Systematic Review.*
                     The entire research protocol is available online at: 
                    *https://effectivehealthcare.ahrq.gov/​products/​child-growth-development-outcomes/​protocol.* This is to notify the public that the EPC Program would find the following information on 
                    *Dietary Total Fat Intake and Dietary Polyunsaturated Fatty Acid Intake and Child Growth and Development Outcomes: A Systematic Review*
                     helpful: A list of completed studies that your organization has sponsored for this topic. In the list, please 
                    *indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number.* *For completed studies that do not have results on ClinicalTrials.gov,*
                     a summary, including the following elements, if relevant: 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. *A list of ongoing studies that your organization has sponsored for this topic.*
                     In the list, please provide the 
                    *ClinicalTrials.gov*
                     trial number or, if the trial is not registered, the protocol for the study including, if relevant, a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes. Description of whether the above studies constitute 
                    *ALL Phase II and above clinical trials*
                     sponsored by your organization for this topic 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 topics 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://effectivehealthcare.ahrq.gov/​email-updates.* *The 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 (KQ) *KQ 1:*
                     What is the association between dietary intake of omega-6 and/or omega-3 polyunsaturated fatty acids during pregnancy and risk of preterm birth? *KQ 1a:*
                     How are these associations affected by intervention/exposure characteristics (for example, the ratio of different fatty acids)? *KQ 2:*
                     What is the association between dietary intake of omega-6 and/or omega-3 polyunsaturated fatty acids during pregnancy and/or lactation and infant/child growth and developmental outcomes? *KQ 2a:*
                     How are these associations affected by intervention/exposure characteristics (for example, the ratio of different fatty acids)?
                    ( print page 90696) *KQ 3:*
                     What is the association between dietary intake of total fat in individuals birth through 18 years of age and measures of growth and development? *KQ4:*
                     What is the association between dietary intake of omega-6 and/or omega-3 polyunsaturated fatty acids in individuals birth through 18 years of age and measures of growth and development? PICOTS (Population, Intervention, Comparator, Outcome, Timing, Setting/Study Design)
Element
Inclusion criteria
Exclusion criteriaPopulation
*Exposure population:* • Individuals who are pregnant (KQ1) and/or lactating (KQ2) of any age or individuals from birth through 18 years of age (KQ3 and 4) from the general population (including those with overweight/obesity) not affected by a disease or health-related condition that impacts fat absorption and/or metabolism; or taking medications that alter the absorption or metabolism of dietary fatty acid 
                             
                                *Outcome population:* 
                             • Offspring of the pregnant individual (birth through 18 years) not taking medications or affected by a disease or health-related condition that impacts fat absorption and/or metabolism 
                             
                                *Note:*
                                 given the distinction between chronological age versus pubertal stage, as well as heterogeneity in enrollment across age ranges, for studies meeting all other eligibility criteria, we will consider exceptions to the age criterion.a
• Non-human participants (
                            *e.g.,*
                             animal studies, in-vitro models).
                             
                                • Studies that enroll participants taking medications or with diseases/health-related conditions that impact fatty acid absorption or metabolism (
                                *e.g.,*
                                 Crohn's disease, ulcerative colitis, short-gut syndrome, cystic fibrosis, celiac). This includes cancer and malabsorption syndromes.
                             
                             • Studies that exclusively enroll participants hospitalized with an illness or injury. 
                             • Studies designed to induce weight loss or treat overweight and obesity through energy restriction or hypocaloric diets for the purposes of treating additional or other medical conditions. 
                             • Studies that exclusively enroll participants with severe undernourishment, underweight, stunting, or wasting. 
                             • Studies that enroll participants who are pre- or post-bariatric surgery. 
                             
                                • Studies with enrollment 
                                *exclusively*
                                 of: pre-term babies (gestational age <37 weeks), babies admitted to the NICU, babies that have low birth weight (<2,500g) and/or babies that are small for gestational age (for assessment of infant and child growth parameters and developmental outcomes).
                             
                             
                                • Studies that enroll infants with conditions treated/prevent by dietary supplementation (
                                *e.g.,*
                                 G- or GJ-tubes, fatty acid oxidation disorders, necrotizing enterocolitis, attention deficit (and/or hyperactivity) disorder, ADHD, autism, etc.).Intervention (Exposure)
*KQ1, 2, and 4:* • Dietary intake of total omega-3 PUFA, total omega-6 PUFA, or total PUFA (omega-3 and omega-6) 
                             • Dietary intake of individual PUFA (examples: linoleic, alpha-linolenic, EPA, DHA) 
                             • Dietary intake of a combination of long-chain PUFA (example: EPA+DHA+DPA; DHA+ARA) 
                             • Dietary intake of polyunsaturated fatty acids in terms of a ratio (example, n-6:n-3 PUFA, DHA:ARA) 
                             
                                *KQ3:* 
                             • Total dietary fat intake (as either grams/day or % of total energy intake from fat) 
                             • A dietary pattern that describes and quantifies intake of total dietary carbohydrate, total fat, and total protein content (examples: low/high-fat diet; low/high-carbohydrate diet; high-protein; ketogenic diet) 
                             
                                *Note:*
                                 Dietary intake can be from foods, supplements, and/or supplemented foods.b
*KQ1, 2, and 4:* 
                                • Studies that do not quantify PUFA intake as either grams/day or % of total energy intake from PUFA (
                                *e.g.,*
                                 studies where exposure is number of fish servings per week).
                             
                             • Studies that do not provide absolute intake of fatty acids included in ratios. 
                             • Studies that only assess fatty acid biomarker wt% of total or concentrations. 
                             • Studies that only assess fatty acid intake via infusions (parenteral [intralipid] or stable isotope). 
                             • Studies that only assess exposure to fatty acids from a single meal, or eating occasion such that usual intake cannot be inferred. 
                             • Studies that examine food products or dietary supplements not widely available to U.S. consumers. 
                             • Multi-component interventions that do not isolate the effect or association of the PUFA exposure. 
                             • Observational studies that do not account for any confounders. 
                             • Studies designed to induce weight loss or treat participants who are determined to be overweight and obese through energy restriction or hypocaloric diets for the purposes of treating additional or other medical conditions. 
                             
                                *KQ3:* 
                             
                                • Studies that do not describe the energy and entire macronutrient distribution of the diet (
                                *i.e.,*
                                 studies that do not report total carbohydrate, total fat, and total protein contents of experimental or baseline diets).( print page 90697)Comparator
*KQ1, 2, and 4:* • Placebo 
                             • Dietary intake of a different amount of fatty acids relevant to the exposure: 
                             ○ Total omega-3 
                             ○ Total omega-6 
                             ○ Individual PUFA 
                             ○ Combination of long-chain PUFA 
                             ○ Intake of PUFA in terms of a ratio 
                             
                                *KQ3:* 
                             • Dietary intake of a different amount of total fat
• Diet(s) with an energy intake that is statistically significantly higher or lower than the intervention/exposure diet (
                            *e.g.,*
                             not isocaloric comparison).
                             • Studies that do not have a statistically significant difference between groups in PUFA or total fat intake. 
                             
                                • Studies comparing undefined exposures (
                                *e.g.,*
                                 comparisons of undefined quartiles).Outcome
*KQ2, 3, and 4:* Infant and child (birth through 18 years) growth parameters 
                             • Birth weight 
                             • Weight and Weight-for-age percentile or Z-score adjusted for gestational age 
                             • Length or Height and Length-for-age or Height-for-age percentile and Z-score adjusted for gestational age 
                             • Head circumference and Head circumference percentile and Z-score adjusted for gestational age 
                             
                                Infant and child (birth through 18 years) developmental outcomes c
                             
                             • Cognitive/neurological 
                             • Language/communication 
                             • Movement/physical 
                             • Visual function/acuity 
                             • Social/emotional learning 
                             
                                *KQ1:* 
                             • Risk of preterm birth
• BMI, BMI z-score.
                             
                                • Body composition and distribution (
                                *e.g.,*
                                 % fat mass, fat-free mass, skin fold thicknesses).
                             
                             • Incidence and prevalence of overweight, obesity.Timing
• All exposure or intervention durations will be includedSetting
• Outpatient; all settings except hospital and acute care will be included
• Inpatient; hospital and acute care.Study Design
• Randomized controlled trials
                             • Prospective cohort studies 
                             • Nested case-control studies
• Narrative reviews.
                             • Systematic reviews. 
                             • Meta-analyses. 
                             • Scoping reviews. 
                             • Umbrella reviews. 
                             • Retrospective cohort studies. 
                             • Non-randomized controlled trials, including quasi-experimental and controlled before-and-after studies. 
                             • Cross-sectional studies. 
                             • Case-control studies. 
                             • All other study designs.Geographic Location
• Locations with food products or dietary supplements widely available to U.S. and/or Canadian consumers
                             
                                • Countries rated very high on the Human Development Index (HDI) d
                                 at the time of data collection
• Locations not rated very high on the HDI.Study Size
• Studies including power calculations or effect sizes
                             • Studies with N ≥30 participants (for randomized clinical trials [RCTs]): ≥10 participants analyzed per study arm)
• Studies with N <30 participants (for RCTs: <10 participants analyzed per study arm), without power calculations or effect sizes.
                             • Case studies and n = 1 samples. 
                             • Non-randomized studies that do not account for any potential confounders.Language
• Articles published in English
• Articles published in languages other than English.Publication Dates
• Articles published during or after 2000
• Articles published prior to 2000.a
                         For studies meeting all other eligibility criteria, studies enrolling populations aged 0 to older than 19 years will be included if: (a) results are stratified by age group, allowing extraction of data for participants aged through 18 years; or (b) 85% of the population is aged through 18 years, if results are not stratified by age group. The one exception is studies of adolescents; for those meeting all other eligibility criteria, studies enrolling adolescents through age 26, regardless of result stratification or percentage of population aged through 18 years, will be included. See the Study Selection section.b
                         Dietary supplement is defined as a product intended to supplement the diet that contains one or more dietary ingredients (including vitamins, minerals, herbs or other botanicals, amino acids, and other substances) intended to be taken by mouth as a pill, capsule, table, or liquid, and that is labeled on the front panel as being a dietary supplement.c
                         See Section IV for an example table of measures with periodicity.d
                         United Nations Development Programme Human Development Reports, 
                        *https://hdr.undp.org/​data-center/​human-development-index#/​indicies/​HDI*.
 Dated: November 8, 2024. Marquita Cullom, Associate Director.


[FR Doc. 2024-26783 Filed 11-15-24; 8:45 am] BILLING CODE 4160-90-P