DATE: January 2020

OHSU HEALTH SYSTEM

OFFICE OF CLINICAL INTEGRATION AND EVIDENCE-BASED PRACTICE
GUIDELINE FOR INDUCTION OF LABOR

Background: The purpose of induction of labor is to on contraction frequency, findings on digital cervical
achieve vaginal delivery by stimulating uterine examination, and clinician judgment. Generally agreed
contractions before the spontaneous onset of labor[1]. that women are in latent phase when are contracting with
Generally, induction of labor has merit as a therapeutic cervical dilation </- 6cm.
option when benefits of expeditious delivery outweigh the Active phase of labor: The point when latent phase ends
risk of continuing the pregnancy. [2] The goal of this and the rate of change of cervical dilation significantly
guideline is to develop clinical practice recommendations increases.
for the appropriate setting, monitoring, and methods of Cervical Ripening: a prelude to the onset of active labor
induction in order to improve maternal and neonatal whereby the cervix becomes soft and compliant. This
health outcomes. allows its shape to change from being long and closed, to
being thinned out and starting to open. It either occurs
Prevalence: The rate of induction of labor more than naturally or as a result of physical or pharmacological
doubled from 1990 through 2012, from 9.6% to 23.3%. interventions[6].
Induction rates were at least twice as high in 2010 as in Foley Catheter: a long, rubber tube with an inflatable
1990 for all gestational age groups except post-term births, balloon on one end that a clinician can fill with air or
which rose 90%.[3] In 2017 the rate of induction of labor sterile water and used to ripen the cervix.
increased to 25.7%. [4] The OHSU Labor and Delivery Unit Cook© Catheter: a silicone double balloon catheter that is
is a high-risk pregnancy tertiary referral center and the inflated and used to ripen the cervix.
rate of induction of labor is 43%[5]. PGE1: or misoprostol is a prostaglandin analogue which is
used as a medication. It causes uterine contractions and
Risks: Risks of IOL are similar to spontaneous labor and the ripening of the cervix. [7]
may include excessive bleeding, infection and need for PGE2: or dinoprostone is also a prostaglandin analogue
cesarean delivery (CD). Rarely, risks may also include used to ripen the cervix and stimulate uterine muscle for
uterine rupture and fetal morbidity. These risks are labor induction.
increased in the context of a medically complex maternal
or fetal patient. Guideline Eligibility Criteria: All patients undergoing
induction of labor.
Definitions:
Induction of labor: The ripening of the cervix and Guideline Exclusion Criteria:
stimulation of uterine contractions before the • Non-cephalic presentation of a live fetus
spontaneous onset of labor with goal to achieve vaginal • >2 cesarean deliveries
delivery. • Any other contraindication to a vaginal delivery
Latent phase of labor: Initial phase of labor when the rate
of cervical dilation is typically slow. The diagnosis is based

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Clinical Practice Recommendations:

Assessment
The Bishop score should be used to rate the readiness of the cervix of labor. With this scoring system, a number ranging from
0-13 is given to rate the condition of the cervix. Cervical Ripening should be considered with a Bishop score of less than 6. –
Strong Recommendation, Moderate Quality of Evidence [8]

Induction of Labor Phase 1: Cervical Ripening

Outpatient
• In low risk patients, outpatient cervical ripening with Foley Catheter may be considered. – Conditional
Recommendation, Low Quality Evidence [9, 10]

Methods for Cervical Ripening:

• It is reasonable to offer membrane sweeping for cervical ripening, with the timing and frequency at the discretion of
the provider and patient. – Strong Recommendation, High Quality Evidence [11, 12]
• Evidence was inconclusive for cervical ripening with castor oil or acupuncture. If patient is interested in these
methods, risk/benefit discussion with provider should include dialogue of inconclusive evidence. – Conditional
Recommendation, Moderate Quality Evidence [13, 14]
• Sexual intercourse should not be routinely recommended solely for the purpose of cervical ripening. Inform patient
that in the evidence, sexual intercourse was not effective for this purpose. – Conditional Recommendation,
Moderate Quality Evidence [15-17]

Inpatient
Monitoring:
• For inpatient cervical ripening, fetal wellbeing should be assessed according to the pharmacologic agent used (see
Table 1). – Consensus Statement

Methods for Cervical Ripening:

• Shared decision making should be used when choosing the method for cervical ripening. – Strong
Recommendation, Very low Quality Evidence [18, 19]
• For inpatient cervical ripening, breast stimulation with a breast pump may be considered. – Conditional
Recommendation, Low Quality Evidence [20, 21]

To assist patients and providers in choosing methods of cervical ripening, OHSU Health System has developed a tiered
approach in which the methods are separated by preferred and alternative methods. The preferred options are chosen
because the evidence has shown them to be as efficacious and without an increased risk of adverse events, and more cost
effective than the alternative methods [22-26]. The tiered approach allows the opportunity to offer other methods if a
patient and provider prefer an alternative method. Varying levels of evidence support each method’s effectiveness and
each method has its own strengths and limitations.
• Preferred Options (see Table 1 for more details) includes:
o Misoprostol
 Vaginal administration, 25µ misoprostol every four hours – Strong Recommendation, Moderate
Quality Evidence[27] or

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 Oral administration, 50µ misoprostol every four hours – Strong Recommendation, Low Quality
Evidence[23, 28] or
 Oral misoprostol stepwise regimen of 50µ then 100µ after four hours followed by another 100µ after
four hours – Strong Recommendation, Very Low Quality Evidence [29, 30]
 For Induction termination or fetal demise < 28 week size uterus refer to “Medical Induction for TOP
Protocol” OHSU Clinical Guideline for alternative misoprostol dosing regimen.
OR
o Foley catheter alone filled with 60mL of saline – Strong Recommendation, Low Quality Evidence [31-34]
OR
o Foley catheter combined with any of the above misoprostol options – Strong Recommendation, Moderate
Quality Evidence [33-38]
o Foley catheter filled with 60mL saline (or Cook© Catheter) with concurrent oxytocin, start at 2 mu/min and
increase by 2 mu/min every 30 min until regular contraction pattern – Conditional Recommendation, Very
Low Quality Evidence [39-41]
 Preferred option for patients undergoing trial of labor after cesarean (TOLAC)
• Alternative Options (see Table 1 for more details) includes:
o Dinoprostone 10mg vaginal insert – Conditional Recommendation, Moderate Quality Evidence [23, 42, 43]
OR
o Cook© Catheter used per the manufacturer’s instructions – Conditional Recommendation, Moderate
Quality Evidence [25, 44]
• Amniotomy, Oxytocin alone, Laminaria tent, and extra-amniotic saline infusion were not included in this evidence
appraisal and can be used at the discretion of the clinician. – Consensus Statement

Induction of Labor Phase 2: Active Labor

Oxytocin:
• Once the cervix is ripened, it is reasonable to use either a lower dose oxytocin protocol (start at 2mU/min and
increase by 2 mu/min q 30 min) or higher dose oxytocin protocol (start at 4 mu/min and increase by 4 mu/min every
30 minutes) for induction of labor. – Strong Recommendation, Moderate Quality Evidence [45, 46]

Induction of Labor: Additional Considerations

Nutrition and Hydration:

• Low risk patients for aspiration should have unrestricted oral intake of fluid during induction of labor. – Strong
Recommendation, Moderate Quality Evidence[47]
• It is reasonable to offer intravenous D5NS/D5LR at the rate of 250mL/h during active labor in women undergoing
induction of labor, may improve outcomes such as shortened duration of labor and reduction in the incidence of
cesarean delivery.-Conditional Recommendation, Moderate Quality Evidence [47]
• Solid food intake was not included in this evidence appraisal and should be a discussion between patient, provider
and anesthesia team. – Consensus Statement

Epidural analgesia:

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• Provide patients in early labor (i.e., <5 cm dilation) the option of neuraxial analgesia on an individualized basis –
Conditional Recommendation, Moderate Quality Evidence
• Do not withhold neuraxial analgesia on the basis of achieving an arbitrary cervical dilation – Strong
Recommendation, Moderate Quality Evidence

Continuous labor support:

Continuous support during labor may improve outcomes for women and infants, defined as support from nurse, midwife,
doula, childbirth educator, family member, friend or spouse/partner. Outcome include increased spontaneous vaginal birth,
shorter duration of labor, and decreased caesarean birth, instrumental vaginal birth, use of any analgesia, use of regional
analgesia, low five-minute Apgar score and negative feelings about childbirth experiences. – Conditional Recommendation,
Low Quality Evidence [12, 48]

Failed Induction Definition

If the maternal and fetal status allow, cesarean deliveries for failed induction of labor in the latent phase can be avoided by
allowing longer durations of the latent phase (up to 24 hours or longer) and requiring that oxytocin be administered for at
least 15 hours after membrane rupture before deeming the induction a failure. – Strong Recommendation, Moderate
Quality Evidence [2, 49, 50]

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Table 1. Cervical Ripening Options

Intervention Dose, timing, and route Monitoring Special Considerations Contraindications

Preferred Methods
Misoprostol Option 1: Vaginal: 25 µ every 4 hours. Continuous electronic fetal heart rate monitoring (CEFM) - Consider stepwise dosing for patients with a BMI Patients with a uterine scar
Max 6 doses and tocometry (TOCO) for at least 3 hours after >30[51] or if patient is not responding to 50 µ every 4 More than 5 painful
Option 2: Oral: 50 µ every 4 hours. Max 6 administration depending on contraction patterns. hours. contractions in 10 min
doses -For Induction termination/fetal demise < 28 wk size
Option 3: Oral Stepwise: begin with 50 µ, uterus refer to “Medical Induction for TOP Protocol”
then continue with 100 µ every 4 hours. OHSU Clinical Guideline.
Max 6 total doses

Foley Catheter plus FC: Saline information below, leave in up CEFM and TOCO for at least 3 hours after administration -Consider step dosing for patients with a BMI >30[51] Uterine scar
misoprostol to 24h or if patient is not responding to 50 µ every 4 hours
Miso: Option 1, 2 or 3 above for dosing -Caution when used with low lying placenta

Foley Catheter Fill to 60 mL with saline and leave in for CEFM and TOCO for at least 30 min post placement Caution when used with low lying placenta
up to 24h

Foley Catheter plus FC: Fill to 60 mL with saline CEFM and TOCO -Preferred option for patients TOLAC
oxytocin Oxytocin: Start at 2mU/min and increase -Use caution when patient has prolonged QT
by 2 mu/min q 30 min) syndrome
-Caution when used with low lying placenta

Alternative Methods
Dinoprostone Insert: 10 mg CEFM and TOCO continuously while in place and at least May be less effective in patients with a BMI >30 [52] Patients with a parity >5
for 15 min after removal Uterine scar
More than 5 painful
contractions in 10 min

Cook© Catheter Use per manufacturer’s instructions CEFM and TOCO for at least 30 min post placement Caution when used with low lying placenta Use per manufacturer’s
(Appendix A) instructions (Appendix A)

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Quality Measures:
• Length of time from induction start to delivery
• Overall vaginal delivery (VD) rate
• VD rate in first 24 hrs. after admission
• Chorioamnionitis rates
• Length of 2nd stage
• Cesarean delivery (CD) rates
• Unexpected newborn complications: Severe

Implementation Plan:
• Outpatient ripening protocol to be developed during implementation.
• Breast stimulation protocol to be developed during implementation.
• Information on induction of labor and the various methods of cervical ripening and induction to be
added to OHSU sponsored birth classes
• When choosing pharmacologic agents for cervical ripening, providers should consider their institution’s
formulary.
• Clinical decision aids and patient education materials to be developed during implementation

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References
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p. 386-97.
2. Caughey, A.B., et al., Safe prevention of the primary cesarean delivery. Am J Obstet
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3. Martin, J.A., et al., Births: final data for 2013. Natl Vital Stat Rep, 2015. 64(1): p. 1-65.
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9. Policiano C, P.M.M.D.C.N., Outpatient versus inpatient cervix priming with Foley
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18. Shetty, A., et al., Women's perceptions, expectations and satisfaction with induced
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19. Moore, J.E., et al., Moving toward patient-centered care: Women's decisions,
perceptions, and experiences of the induction of labor process. 2014. 1(2): p. 138-46.
20. Singh, N., et al., Breast stimulation in low-risk primigravidas at term: does it aid in
spontaneous onset of labour and vaginal delivery? A pilot study. BioMed Research
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21. Kavanagh, J., A.J. Kelly, and J. Thomas, Breast stimulation for cervical ripening and
induction of labour. Cochrane Database of Systematic Reviews, 2005(3): p. CD003392.

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22. Hofmeyr, G.J., A.M. Gulmezoglu, and C. Pileggi, Vaginal misoprostol for cervical
ripening and induction of labour. Cochrane Database of Systematic Reviews, 2010(10):
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23. Chen, W., et al., A systematic review and network meta-analysis comparing the use of
Foley catheters, misoprostol, and dinoprostone for cervical ripening in the induction of
labour. [Review]. 2016. 1(3): p. 346-54.
24. Austin, S.C., L. Sanchez-Ramos, and C.D. Adair, Labor induction with intravaginal
misoprostol compared with the dinoprostone vaginal insert: a systematic review and
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25. Yang, F., et al., Double-balloon versus single-balloon catheter for cervical ripening and
labor induction: A systematic review and meta-analysis. [Review]. 2018. 1(1): p. 27-34.
26. Gommers, J.S.M., et al., Risk of maternal, fetal and neonatal complications associated
with the use of the transcervical balloon catheter in induction of labour: A systematic
review. [Review]. 2017. 1: p. 73-84.
27. Lin, M.G., et al., Misoprostol for labor induction in women with term premature rupture
of membranes: a meta-analysis. 2005. 1(3): p. 593-601.
28. Dallenbach, P., et al., Oral misoprostol or vaginal dinoprostone for labor induction: a
randomized controlled trial. 2003. 1(1): p. 162-7.
29. Colon, I., et al., Prospective randomized clinical trial of inpatient cervical ripening with
stepwise oral misoprostol vs vaginal misoprostol. 2005. 1(3): p. 747-52.
30. Fisher, S.A., V.P. Mackenzie, and G.A. Davies, Oral versus vaginal misoprostol for
induction of labor: a double-blind randomized controlled trial. 2001. 1(4): p. 906-10.
31. Jozwiak, M., et al., Mechanical methods for induction of labour. [Review]. 2012. 1(3): p.
Cd001233.
32. Vaknin, Z., Y. Kurzweil, and D. Sherman, Foley catheter balloon vs locally applied
prostaglandins for cervical ripening and labor induction: a systematic review and
metaanalysis. [Review]. 2010. 1(5): p. 418-29.
33. Levy, R., et al., A randomized trial comparing a 30-mL and an 80-mL Foley catheter
balloon for preinduction cervical ripening. 2004. 1(5): p. 1632-6.
34. Sandberg, E.M., et al., Foley catheter for induction of labour filled with 30mL or 60mL:
A randomized controlled trial. 2017. 1: p. 150-155.
35. Chen, W., et al., Meta-analysis of Foley catheter plus misoprostol versus misoprostol
alone for cervical ripening. [Review]. 2015. 1(3): p. 193-8.
36. Levine, L.D., et al., Mechanical and Pharmacologic Methods of Labor Induction: A
Randomized Controlled Trial. Obstet Gynecol, 2016. 128(6): p. 1357-1364.
37. Al-Ibraheemi, Z., et al., Misoprostol With Foley Bulb Compared With Misoprostol Alone
for Cervical Ripening: A Randomized Controlled Trial. 2018. 1(1): p. 23-29.
38. Osoti, A., et al., Effect of extra-amniotic Foley's catheter and vaginal misoprostol versus
vaginal misoprostol alone on cervical ripening and induction of labor in Kenya, a
randomized controlled trial. 2018. 1(1): p. 300.
39. Moraes Filho, O.B., R.M. Albuquerque, and J.G. Cecatti, A randomized controlled trial
comparing vaginal misoprostol versus Foley catheter plus oxytocin for labor induction.
2010. 1(8): p. 1045-52.

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40. El Khouly, N.I., A prospective randomized trial comparing Foley catheter, oxytocin, and
combination Foley catheter-oxytocin for labour induction with unfavourable cervix.
2017. 1(3): p. 309-314.
41. Schoen, C.N., et al., Intracervical Foley Catheter With and Without Oxytocin for Labor
Induction: A Randomized Controlled Trial. 2017. 1(6): p. 1046-1053.
42. Alfirevic, Z., et al., Labour induction with prostaglandins: a systematic review and
network meta-analysis. [Review]. 2015. 1: p. h217.
43. Boulvain, M., A. Kelly, and O. Irion, Intracervical prostaglandins for induction of
labour. [Review] [148 refs]. 2008. 1(1): p. Cd006971.
44. Du, Y.M., et al., Double-balloon catheter versus prostaglandin E2 for cervical ripening
and labour induction: a systematic review and meta-analysis of randomised controlled
trials. 2017. 1(6): p. 891-899.
45. Budden, A., L.J.Y. Chen, and A. Henry, High-dose versus low-dose oxytocin infusion
regimens for induction of labour at term. Cochrane Database of Systematic Reviews,
2014(10): p. CD009701.
46. Zhang, J., et al., Oxytocin regimen for labor augmentation, labor progression, and
perinatal outcomes. Obstet Gynecol, 2011. 118(2 Pt 1): p. 249-56.
47. Ehsanipoor, R.M., et al., Intravenous fluid rate for reduction of cesarean delivery rate in
nulliparous women: a systematic review and meta-analysis. [Review]. 2017. 1(7): p. 804-
811.
48. Hodnett, E.D., et al., Continuous support for women during childbirth. Cochrane
Database Syst Rev, 2011(2): p. Cd003766.
49. Rouse, D.J., et al., Failed labor induction: toward an objective diagnosis. Obstet
Gynecol, 2011. 117(2 Pt 1): p. 267-72.
50. Grobman, W.A., et al., Defining failed induction of labor. American Journal of Obstetrics
& Gynecology, 2018. 218(1): p. 122.e1-122.e8.
51. Pevzner, L., et al., Effects of maternal obesity on duration and outcomes of prostaglandin
cervical ripening and labor induction. 2009. 1(6): p. 1315-21.
52. Gauthier, T., et al., Obesity and cervical ripening failure risk. The Journal of Maternal-
Fetal & Neonatal Medicine, 2012. 25(3): p. 304-307.

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Guideline Preparation 1. Review Preparation

This guideline was prepared by the Office of Clinical - PICO questions established
Integration (CI) and Evidence-Based Practice (EBP) in - Evidence search confirmed with content experts
collaboration with content experts at OHSU Health 2. Review of Existing Internal and External Guidelines
System. - Literature Review of Relevant Evidence
3. Critically Analyze the Evidence
Content Expert Team 4. Summarize the Evidence by preparing the guideline, and
order sets
Aaron Caughey, MD, Maternal Fetal Medicine, OB/GYN,
OHSU
Evaluating the Quality of the Evidence
Amy Hermesch, MD, Maternal Fetal Medicine, OHSU
Aurelia Hidalgo, RN, Labor and Delivery, OHSU Published clinical guidelines were evaluated for this
Brandon Togioka, MD, Anesthesiology, OHSU review using the University of Pennsylvania’s
Emma Brooks, MD, Family Medicine, OHSU Trustworthy Guideline Rating Scale. The summary of
Heather Holmes, MD, Family Medicine, OHSU these guidelines are included in the evidence summary.
Jessica Flynn, MD, Family Medicine, OHSU The rating scale is based on the Institute of Medicine’s
Juliette Bauer, Tuality “Standards for Developing Trustworthy Clinical Practice
Julie Crawford, MD, OB/GYN, Adventist Guidelines” (IOM), as well as a review of the AGREE
Julia Vance, CNM, OHSU Enterprise and Guidelines International Network
Kristin Hinton, Patient Representative domains. This scale evaluates a guideline’s transparency,
Laura Jenson, CNM, Midwifery, OHSU conflict of interest, development group, systematic review,
Leo Pereira, MD, Maternal Fetal Medicine, OHSU supporting evidence, recommendations, external review
Lindsey Kennedy, Tuality and currency and updates. The purpose of this scale is to
Lisa Bayer, MD, OB/GYN, OHSU focus on the weaknesses of a guideline that may reduce
Lisa Chickadonz, DNP, CNM, Labor and Delivery and the trust a clinical user can have in the guideline, and
Mother-baby Unit, OHSU distinguish weaknesses in documentation (e.g. guideline
Lishiana Shaffer, MD, OB/GYN, OHSU does not have a documented updating process) from
Margaret Grace, RN, Labor and Delivery, OHSU weaknesses in the guidance itself (e.g. recommendations
Mónica Arce, CNM, OB Clinician Lead, Virginia Garcia are outdated).
Women’s Clinic
Rose Stockman, Birth Educator, OHSU The GRADE (Grading of Recommendations,
Sam Crane, MD, Family Medicine, OHSU Assessment, Development and Evaluation) criteria
Sharon Wong, MD, OB/GYN, Adventist were utilized to evaluate the body of evidence used to
Sylvana Bennet, MD, OB/GYN, Tuality make clinical recommendations. The table below defines
Tammy Wagner, MD, Informatics, OHSU how the quality of the evidence is rated and how a strong
Terri Wright, RN, Quality, OHSU versus conditional recommendation is established. The
evidence summary reflects the critical points of evidence.
Clinical Integration and EBP Team
Tovah Kohl, MA, EBP Program Manager Recommendation
Andrew Hamilton, MS/MLS, Liaison Librarian Desirable effects clearly
STRONG outweigh undesirable effects
Stephanie Halvorson, MD, Clinical Integration Medical
or vice versa
Director/Hospital Medicine
Desirable effects closely
Marian McDonagh, PharmD, Associate Director of the WEAK balanced with undesirable
Evidence-based Practice Center (EPC) effects
Quality Type of Evidence
Development Process Consistent evidence from
well-performed RCTs or
This guideline was developed using the process outlined in
High exceptionally strong
the CI and EBP Manual (2016). The review summary evidence from unbiased
documents the following steps: observational studies

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Evidence from RCTs with Expert Teams will be involved with every review and
important limitations (e.g., update.
inconsistent results,
methodological flaws,
Moderate indirect evidence, or Disclaimer
imprecise results) or
Guideline recommendations are made from the best
unusually strong evidence
from unbiased observational evidence, clinical expertise and consensus, in addition to
studies thoughtful consideration for the patients and families
Evidence for at least 1 cared for within the Integrated Delivery System. When
critical outcome from evidence was lacking or inconclusive, content experts
Low observational studies, from made recommendations based on consensus. Expert
RCTs with serious flaws or consensus is implied when a reference is not otherwise
indirect evidence
indicated.
Evidence for at least 1
critical outcome from
Very Low unsystematic clinical The guideline is not intended to impose standards of care
observations or very indirect preventing selective variation in practice that is necessary
evidence to meet the unique needs of individual patients. The
Criteria for increasing or decreasing level physician must consider each patient and family’s
Reductions circumstance to make the ultimate judgment regarding
Study quality has serious (–1) or very serious (–2) problems best care.
Important inconsistency in evidence (–1)
Directness is somewhat (–1) or seriously (–2) uncertain
Sparse or imprecise data (–1)
Reporting bias highly probable (–1)
Increases
Evidence of association† strong (+1) or very strong (+2)
†Strong association defined as significant relative risk (factor of
2) based on consistent evidence from two or more studies with
no plausible confounders Very strong association defined as
significant relative risk (factor of 5) based on direct evidence
with no threats to validity.

Recommendations
Recommendations for the guidelines were directed by the
existing evidence, content experts, and consensus. Patient
and family preference were included when possible.
When evidence is lacking, options in care are provided in
the guideline and the order sets that accompany the
guideline.

Approval Process
Guidelines are reviewed and approved by the Content
Expert Team, Office of CI and EBP, Knowledge
Management and Therapeutics Committee, Professional
Board, and other appropriate hospital committees as
deemed appropriate for the guideline’s intended use.
Guidelines are reviewed and updated as necessary every 2
to 3 years within the Office of CI and EBP at OHSU. Content

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Appendix A. Cook© Catheter Instruction Guide

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