Evidence map›Paper›PMID 31683925›Full record

ArticleHealthcare (Basel, Switzerland)2019

Evaluating the Comparative Effectiveness of Two Diets in Pediatric Inflammatory Bowel Disease: A Study Protocol for a Series of N-of-1 Trials.

Heather C Kaplan, Lisa Opipari-Arrigan, Christopher H Schmid, Christine L Schuler, Shehzad Saeed, Kimberly L Braly, Jennifer C Burgis, Kaylie Nguyen, Sheri Pilley, Julie Stone and 2 more

Open access · goldAbstract read
In one paragraph

Article in Healthcare (Basel, Switzerland), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.3field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 17 citations in OpenAlex.

  1. Article
  2. Protocol of a Series ofCurrent developments in nutrition · 2025
    Article
  3. Article
  4. Article
  5. Article
  6. Algorithmic lifestyle optimization.Journal of the American Medical Informatics Association : JAMIA · 2022
    Article
  7. Review
  8. Review
  9. Article
  10. Article
  11. Bayesian Models for N-of-1 Trials.Harvard data science review · 2022
    Article
  12. N-of-1 Trials in Healthcare.Healthcare (Basel, Switzerland) · 2021
    Article
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 1 country.

Heather C KaplanPerinatal Institute and James M. Anderson Center for Health Systems Excellence, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA. heather.kaplan@cchmc.org.
Lisa Opipari-ArriganDepartment of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH 45229, USA. Lisa.Opipari@cchmc.org.
Christopher H SchmidDepartment of Biostatistics, Center for Evidence Synthesis in Health, Brown University School of Public Health, Providence, RI 02912, USA. christopher_schmid@brown.edu.
Christine L SchulerDepartment of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH 45229, USA. christine.schuler@cchmc.org.
Shehzad SaeedDivision of Pediatric Gastroenterology, Dayton Children's Hospital, Wright State University; Dayton, OH 45404, USA. SaeedS@childrensdayton.org.
Kimberly L BralyIndependent Consultant, Division of Pediatric Gastroenterology, Seattle Children's Hospital, Seattle, WA 98105, USA. kim@kimbralynutrition.com.
Jennifer C BurgisDivision of Pediatric Gastroenterology, University of California San Francisco, San Francisco, CA 94158, USA. jennifer.burgis@ucsf.edu.
Kaylie NguyenDivision of Pediatric Gastroenterology, Lucile Packard Children's Hospital, Stanford Univeristy, Palo Alto, CA 94304, USA. kanguyen@stanfordchildrens.org.
Sheri PilleyParent Working Group, ImproveCareNow, Inc. Burlington, VT 05405, USA. sheripilley@gmail.com.
Julie StoneParent Working Group, ImproveCareNow, Inc. Burlington, VT 05405, USA. stone.juliem@gmail.com.
Gisele WoodwardParent Working Group, ImproveCareNow, Inc. Burlington, VT 05405, USA. giselewoodward@yahoo.com.
David L SuskindDivision of Gastroenterology, Hepatology and Nutrition Seattle Children's Hospital, University of Washington, Seattle, WA 98105, USA. david.suskind@seattlechildrens.org.
Cincinnati Children's Hospital Medical Center · USSeattle Children's Hospital · USBrown University · USLucile Packard Children's Hospital · USUniversity of California, San Francisco · USWright State University · US

Funding

Kenneth Rainin Foundation n/aPatient-Centered Outcomes Research Institute contract number PPRND-1507-31321
6 · The paper itself

Abstract

Inflammatory bowel disease (IBD) affects 3 million children and adults in the US. Treatment involves medications with considerable risk profiles. Dietary modification, such as the specific carbohydrate diet (SCD), may be helpful in treating IBD, but there is insufficient evidence of its effectiveness. N-of-1 trials are ideal for addressing this important research question. The Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease (PRODUCE) study employs a series of 50 individual N-of-1 trials that compare the SCD to a modified SCD. Treatment periods are assigned in blocks of two, with each patient completing two balanced treatment blocks. Patients are randomized to start with the SCD or modified SCD and alternate between conditions for four eight-week periods. A mobile app guides collecting and viewing data, transitioning diets, and reviewing personal results. Primary outcomes include patient reported outcomes (PROs) of stool frequency, stool consistency, pain interference, and gastrointestinal (GI) symptom severity. We examine changes in inflammation via fecal calprotectin. Participants will receive a personalized answer regarding comparative effectiveness between the SCD and a less restrictive diet option (modified SCD), as well as compared to their baseline diet. We will aggregate the results of completed N-of-1 trials across patients to estimate population level comparative effectiveness of these treatments and the effectiveness of each diet.

Indexed as

Crohn’s diseaseImproveCareNowinflammatory bowel diseasespecific carbohydrate dietulcerative colitis

Identifiers

PMID31683925
PMCPMC6956096
OpenAlexW2983130593

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.