EVIDENCE BASED

DIETARY GUIDANCE FOR

PATIENTS CONSIDERING
GLUTEN FREE DIET
Kristi Coe MS, RN
Cedarville University

(C) Copyright 2012-2018, The Helene Fuld Health Trust National Institute for Evidence-based Practice
 Organizational Culture
• Alignment with EBP?
• Mission
“Utilizes evidence-based knowledge to achieve high-quality outcomes”
• Vision
Not explicitly stated
• Philosophy
Produce excellent clinical leaders with service mindset for world impact
• Leadership
DNP leadership; PhD teaching our undergrad EBP; NPs in Campus Health Services

(C) Copyright 2012-2018, The Helene Fuld Health Trust National Institute for Evidence-based Practice
Background of the Issue
 Increase in students with mental health issues and non-specific physical symptoms
 Some studies report that 50% of athletes may voluntarily avoid gluten for health reasons
 Many patients are experimenting with rigorous dietary interventions
 Gluten free diet advocates claim to address obesity, cardiovascular risk, neuropsychiatric
symptoms, fatigue, weight loss, GI symptoms
 Is this something that we should be encouraging as a trial?

Significance of the Issue

 15.5 billion spent on gluten-free foods (2016)
 Celiac disease affects less than 1% of population
 1/3 of adult Americans want to reduce/eliminate gluten
 There could be health factors related to cardiovascular disease that we have not yet measured
well

(Niland, B. ( 1 ), & Cash, B. D. ( 1 ). (2018). Health benefits and adverse effects of a gluten-free diet in non-celiac disease patients. Gastroenterology and Hepatology, 14(2), 82-
91)

(C) Copyright 2012-2018, The Helene Fuld Health Trust National Institute for Evidence-based Practice
 Step 0: Problem/Clinical Inquiry
• We have an increasing number of students that are struggling with mental health
issues, vague physical symptoms or are pursuing higher levels of performance
through health. Many of them are trying aggressive dietary interventions such as
gluten free diets. I wanted to know if this is something that should be encouraged
as an evidence based health behavior.

(C) Copyright 2012-2018, The Helene Fuld Health Trust National Institute for Evidence-based Practice
 Organizational Readiness
• Are we ready for EBP?
• Anticipated Stakeholders
Students
Student health clinic on campus
Providers
• Barriers
Level of impact available due to organizational structure
Formal dissemination plan across campus
• Facilitators
NPs in student health; nursing faculty, counseling services, athletic training staff

(C) Copyright 2012-2018, The Helene Fuld Health Trust National Institute for Evidence-based Practice
 Step 1: PICOT Question
• P: non-celiac disease patients
• I: gluten free diet
• C: regular diet
• O: health outcomes

PICO QUESTION: In patients with non-celiac disease, does a gluten free diet
compared to a regular diet affect health outcomes?

(C) Copyright 2012-2018, The Helene Fuld Health Trust National Institute for Evidence-based Practice
 Step 2: Search Strategy
• PubMed, CINAHL, Open Access
• Search terms: non-celiac disease, gluten free diet, GFD, non-celiac gluten
sensitivity (NCGS), gluten containing diet, GCD
• Limiters: 2013-present, scholarly peer reviewed, RCT (PubMed only)
• Results: 115
• 109 excluded due to lack of relevance, inclusion of celiac disease, low level of
evidence (with exception of 1 expert opinion)

(C) Copyright 2012-2018, The Helene Fuld Health Trust National Institute for Evidence-based Practice
 Critical Appraisal
Article Design Keep ?
Evidence for the presence of non-celiac gluten sensitivity in
patients with functional gastrointestinal symptoms: Results
from a multicenter randomized double-blind placebo- RCT/CO/Blinding
controlled gluten challeng High level/High quality KEEP

An exploration into the motivation for gluten avoidance in Qualitative/Exploratory

the absence of coeliac disease Low level/High quality KEEP

Long term gluten consumption in adults without celiac

disease and risk of coronary heart disease: Prospective
cohort study. Prospective cohort High Level/High quality KEEP

Re-challenge studies in non-celiac gluten sensitivity: A

systematic review and meta-analysis. Systematic Review/Meta-analysis High Level/High quality KEEP

Suspected nonceliac gluten sensitivity confirmed in few

patients after gluten challenge in double-blind, placebo-
controlled trials. High Level/ High quality KEEP

Health benefits and adverse effects of a gluten-free diet in

non-celiac disease patients. Gastroenterology and
Hepatology, 14(2), 82-91 Expert opinion Low Level/High quality KEEP

(C) Copyright 2012-2018, The Hellene Fuld Health Trust National Institute for Evidence-based Practice
 Step 3: Evaluation/Summary
Title/Author CF Design Sample/Setting Major Variables Measurement tools Data analysis Findings LOE Additional
Elli, L., Tomba, C.,
Branchi, F., Roncoroni,
L., Lombardo, V.,
Bardella, M., . . . Fini, L.
(2016). Evidence for
the presence of non-
celiac gluten sensitivity
in patients with
functional
gastrointestinal Symptomatic
symptoms: Results improvement: (p=.001);
from a multicenter 14% responding to gluten
randomized double- withdrawal showed
blind placebo- symptomatic relapse Salerno Experts'
controlled gluten during challenge; 14 Criteria (first
challenge. Nutrients, 8( Mann Whitney; patients responded to attempt to apply
2), 84. NA RCT/CO/Blinding Italy/140/outpatient GI gluten re-challenge VAS score ANOVA placebo II to clinical practice)

Harper, L., & Bold, J.

(2018). An exploration
into the motivation for
gluten avoidance in the Physical/pscyhological
absence of coeliac Health Belief
disease.Gastroenterolo Feelings
gy & Hepatology from Other foods/factors
Bed to Bench, 11(3), Qualitative/Explo reasons for GFD for non Professional support "Grains and sugar
259-268 NA ratory online survey/n=87 celiac member checking Thematic analysis Difficulties of being GFD VI is killing us"

(C) Copyright 2012-2018, The Helene Fuld Health Trust National Institute for Evidence-based Practice
 Step 3: Evaluation/Summary
Title/Author CF Design Sample/Setting Major Variables Measurement tools Data analysis Findings LOE Additional

Lebwohl, B., Cao, Y.,

Zong, G., Hu, F. B.,
Green, P. H., Neugut,
A. I., . . . Giovannucci,
E. (2017). Long term The promotion of
gluten consumption in gluten free diets in
adults without celiac the absence of
disease and risk of Gluten inclusion not celiac disease
coronary heart associated with CHD should not be
disease: Prospective 64,714 health Exposure: consumption Lack of gluten may affect encouraged; did
cohort study. Bmj, 357, Prospective professionals of grain Outcome: CHD (fatal CV risk (low whole grains) not look at GI
j1892. NA cohort 2 national surveys or non fatal MI) Hazard ratios IV symptoms

Lionetti, E., Pulvirenti,

A., Vallorani, M.,
Catassi, G., Verma, A.
K., Gatti, S., & Catassi,
C. (2017). Re-challenge
studies in non-celiac
gluten sensitivity: A
systematic review and
meta-
analysis. Frontiers in PRISM
Physiology, 8, 621. A Not significant RR of Salerno criteria
doi:10.3389/fphys.201 Report 4 meta-analysis of relapse after challenge more accurately
7.00621. ing SR/MA 11 studies (n=1684) Gluten rechallenge subgroups compared to placebo I identified NCGS

(C) Copyright 2012-2018, The Helene Fuld Health Trust National Institute for Evidence-based Practice
 Step 3: Evaluation/Summary
Title/Author CF Design Sample/Setting Major Variables Measurement tools Data analysis Findings LOE Additional

Molina-Infante, J., &

Carroccio, A. (2017).
Suspected nonceliac gluten
sensitivity confirmed in few 16% of NCGS (38
patients after gluten 80% of nonceliac out of 231)
challenge in double-blind, patients after a showed gluten
placebo-controlled favorable response specific
trials. Clinical systematic summary to GFD cannot reach a symptoms.
Gastroenterology and review of measures of NCGS diagnosis after a 40% had a
Hepatology, 15(3), 339-348 RCT 1312 adults gluten re-challenge summary outcomes challenge I nocebo response
Niland, B. ( 1 ), &
Cash, B. D. ( 1 ). Nutritional deficiencies
(2018). Health of the GFD;
benefits and adverse no compelling evidence
effects of a gluten- in PWAG;
free diet in non- women on GFD hae
celiac disease lower amounts of carbs,
patients. Gastroenter fiber, niancin folate most non-celiac
ology and calcium; do not consult
Hepatology, 14(2), expert gluten free diets in higher in fat saturated with a health
82-91 NA opinion non-celiac patients fat, cholesterol VII care provider

(C) Copyright 2012-2018, The Helene Fuld Health Trust National Institute for Evidence-based Practice
 Step 3: Levels of Evidence Synthesis Table
X (copy symbol as needed) 1 2 3 4 5 6

X
Level I: Systematic review X
or meta-analysis (10)
(11)
(5 new)
Level II: Randomized controlled trial X
Level III: Controlled trial
without randomization
Level IV: Case-control or
cohort study X
Level V: Systematic review
of qualitative or descriptive
studies
Level VI: Qualitative or
descriptive study, CPG, X
Lit Review, QI or EBP project

Level VII: Expert opinion X

©Copyright 2011-2018, Lynn Gallagher-Ford; The Helene Fuld Health Trust National Institute for Evidence-based Practice in Nursing and Healthcare. Adapted from the AJN
Series, Evidence-Based Practice, Step by Step: Critical Appraisal of the Evidence Part III Article. This form may be used for educational & research purposes without
permission.
 Step 3: Outcomes Synthesis Table
(30%) 1 2 3 4 5 6

↓
↓
Outcome #1 ↓ (16% with
gluten re-challenge (less than 40%) (14% with NE NE NE
(30%) 40% nocebo
placebo response)
response)
Outcome #2
SRWG ↑ ↑ NE ↑ ↑ ↑
Outcome #3
QOL ↓ ↓ NE NE NE ↓
✓ ✓ ✓
Outcome #4
Health beliefs NE NE NE
✓
Outcome #4
CHD Incidence with GCD NE NE — NE NE

SYMBOL KEY
↑ = Increased, ↓ = Decreased, — = No Change, NE = Not Examined, NR = Not Reported, ✓ = applicable or
present
LEGEND: SRWG- symptomatic relapse with gluten; QOL- quality of life; CHD incidence with gluten
containing diet
©Copyright 2011-2018, Lynn Gallagher-Ford; The Helene Fuld Health Trust National Institute for Evidence-based Practice in Nursing and Healthcare. Adapted from the AJN
Series, Evidence-Based Practice, Step by Step: Critical Appraisal of the Evidence Part III Article. This form may be used for educational & research purposes without
permission.
 Step 4: Evidence-based Practice Change
Recommendation
• Based on the evidence a gluten free diet (GFD) should be recommended for those
with diagnosed celiac disease, wheat allergy, and non-celiac gluten sensitivity (as
confirmed with a gluten re-challenge test and Salerno criteria)1.
• Pursue alternative diagnosis for patients struggling with symptomatic
management that do not meet re-challenge test
• For people who avoid gluten (PWAG) educate on possibility of nutritional
deficiencies and offer alternatives

Catassi, C., Elli, L., Bonaz, B., Bouma, G., Carroccio, A., Castillejo, G., ... & Dieterich, W. (2015). Diagnosis of non-celiac gluten sensitivity (NCGS): the Salerno experts’
criteria. Nutrients, 7(6), 4966-4977.

(C) Copyright 2012-2018, The Helene Fuld Health Trust National Institute for Evidence-based Practice
Step 4: Evidence-based Practice Change
Implementation
• Key Action #1
Meet with campus health providers (2 NPs and 1 MD) to share findings and develop
protocol
• Key Action #2
Offer workshop for students in conjunction with Counseling Services
• Key Action #3
Work inter-professionally with Athletic Training program to provide education to
athletes and those that care for them

(C) Copyright 2012-2018, The Helene Fuld Health Trust National Institute for Evidence-based Practice
 Role of the EBP Mentor
• Key Action #1
Coordinate with Campus Health Services Director to ensure buy in. Champion EBP
to stakeholders within this facility. Provide guidance on protocol development.
• Key Action #2
Coordinate with Student Life Division to ensure buy in. Champion EBP with this
service division. Consult with EBP Leader when necessary.
• Key Action #3
Coordinate with Athletic Director and program director of the Athletic Training
program to ensure buy in. Champion EBP with this academic/athletic division.

(C) Copyright 2012-2018, The Helene Fuld Health Trust National Institute for Evidence-based Practice
 Role of the EBP Leader
• Key Action #1
Develop protocol with campus clinic team. Monitor implementation and referrals
• Key Action #2
Develop educational workshop for students and coordinate with Counseling
Services for delivery
• Key Action #3
Develop educational workshop for athletes and coordinate inter-professionally with
Athletic Training staff for delivery

(C) Copyright 2012-2018, The Helene Fuld Health Trust National Institute for Evidence-based Practice
 Step 5: Measurement Plan
Outcomes to be measured
 Track number of protocol initiated referrals for NCGS diagnosis from campus
health
 Give pre and post-test regarding NCGS, GFD, and nutrition to measure knowledge
and attitudes before and after educational intervention with counseling services
clients and athletes

(C) Copyright 2012-2018, The Helene Fuld Health Trust National Institute for Evidence-based Practice
 Recognition & Celebration Plan
• Host pizza party lunch for campus stakeholders to demonstrate appreciation for
their support! (No gluten free crusts).

(C) Copyright 2012-2018, The Helene Fuld Health Trust National Institute for Evidence-based Practice
 Step 6: Dissemination Plan
• Present at campus research symposium
• Present at Wellness Conference for Ohio Nurses Association
• Work inter-professionally with a dietician/nutritionist to publish

(C) Copyright 2012-2018, The Helene Fuld Health Trust National Institute for Evidence-based Practice
 Your “Aha!” Moment
• PICOT question is not your project….
• Let me help you interpret that forest plot……

(C) Copyright 2012-2018, The Helene Fuld Health Trust National Institute for Evidence-based Practice
 References
Elli, L., Tomba, C., Branchi, F., Roncoroni, L., Lombardo, V., Bardella, M., . . . Fini, L. (2016). Evidence for the presence of non-celiac gluten sensitivity
in patients with functional gastrointestinal symptoms: Results from a multicenter randomized double-blind placebo-controlled gluten
challenge. Nutrients, 8(2), 84.

Harper, L., & Bold, J. (2018). An exploration into the motivation for gluten avoidance in the absence of coeliac disease.Gastroenterology &
Hepatology from Bed to Bench, 11(3), 259-268.

Lebwohl, B., Cao, Y., Zong, G., Hu, F. B., Green, P. H., Neugut, A. I., . . . Giovannucci, E. (2017). Long term gluten consumption in adults without celiac
disease and risk of coronary heart disease: Prospective cohort study. Bmj, 357, j1892.

Lionetti, E., Pulvirenti, A., Vallorani, M., Catassi, G., Verma, A. K., Gatti, S., & Catassi, C. (2017). Re-challenge studies in non-celiac gluten sensitivity:
A systematic review and meta-analysis. Frontiers in Physiology, 8, 621. doi:10.3389/fphys.2017.00621.

Molina-Infante, J., & Carroccio, A. (2017). Suspected nonceliac gluten sensitivity confirmed in few patients after gluten challenge in double-blind,
placebo-controlled trials. Clinical Gastroenterology and Hepatology, 15(3), 339-348.

(C) Copyright
Catassi, C., Elli, 2012-2018,
L., Bonaz,The
B.,Helene
Bouma, Fuld
G.,Health Trust National
Carroccio, InstituteG.,
A., Castillejo, for ...
Evidence-based
& Dieterich,Practice
W. (2015). Diagnosis of non-celiac gluten sensitivity (NCGS): the
Salerno experts’ criteria. Nutrients, 7(6), 4966-4977.