Attachment 2 VA DoD Opioids CPG Provider Summary Print Ready.pdf

VA/DoD Clinical Practice Guidelines

The Use of Opioids in the Management of Chronic Pain

Provider Summary Version 4.0 | 2022

VA/DoD CLINICAL PRACTICE GUIDELINE

FOR THE USE OF OPIOIDS IN THE

MANAGEMENT OF CHRONIC PAIN

Department of Veterans Affairs

Department of Defense

Provider Summary

QUALIFYING STATEMENTS

The Department of Veterans Affairs and the Department of Defense guidelines are based upon the best information available at the time of publication. They are designed to provide information and assist decision making. They are not intended to define a standard of care and should not be construed as one.

Neither should they be interpreted as prescribing an exclusive course of management.

This Clinical Practice Guideline is based on a systematic review of both clinical and epidemiological evidence. Developed by a panel of multidisciplinary experts, it provides a clear explanation of the logical relationships between various care options and health outcomes while rating both the quality of the evidence and the strength of the recommendation.

Variations in practice will inevitably and appropriately occur when clinicians take into account the needs of individual patients, available resources, and limitations unique to an institution or type of practice.

Every healthcare professional making use of these guidelines is responsible for evaluating the appropriateness of applying them in the setting of any particular clinical situation with a patient-centered approach.

These guidelines are not intended to represent Department of Veterans Affairs or TRICARE policy.

Further, inclusion of recommendations for specific testing and/or therapeutic interventions within these guidelines does not guarantee coverage of civilian sector care. Additional information on current TRICARE benefits may be found at www.tricare.mil by contacting your regional TRICARE Managed Care Support Contractor.

Version 4.0 – 2022

VA/DoD CPG for the Use of Opioids in the Management of Chronic Pain – Provider Summary

May 2022

Table of Contents

Introduction

Recommendations

Algorithm

Module A: Determination of Appropriateness for Opioids for Chronic Pain

Module B: Initiation of Treatment with Opioids

Module C: Maintaining, Tapering, Discontinuing, or Switching from Full Agonist Opioids

Scope of the CPG

Methods

Guideline Work Group

Patient-centered Care

Shared Decision Making

Patients with Co-occurring Conditions

References

May 2022 Page 1 of 18

Introduction

The Department of Veterans Affairs (VA) and Department of Defense (DoD) Evidence-Based Practice Work Group (EBPWG) was established and first chartered in 2004, with a mission to advise the Health Executive Committee (HEC) “… on the use of clinical and epidemiological evidence to improve the health of the population …” across the Veterans Health Administration (VHA) and Military Health System (MHS), by facilitating the development of clinical practice guidelines (CPGs) for the VA and DoD populations.(1) Development and update of VA/DoD CPGs is funded by VA Evidence Based Practice, Office of Quality and Patient Safety. The system-wide goal of evidence-based CPGs is to improve patient health and well-being.

In February 2017, the VA and DoD published a CPG on Opioid Therapy for Chronic Pain (2017 VA/DoD Opioids CPG), which was based on evidence reviewed through December 2016. Since the release of that CPG, a growing body of research has expanded the evidence base and understanding of the use of opioids in the management of chronic pain. Consequently, the VA/DoD EBPWG initiated the update of the 2017 VA/DoD Opioids CPG in 2020. This updated CPG’s use of Grading of Recommendations Assessment, Development and Evaluation (GRADE) reflects a more rigorous application of the methodology than previous iterations. Consequently, the strength of some recommendations may have been modified due to the confidence in the quality of the supporting evidence (see Evidence Quality and Recommendation Strength in the full CPG).

This CPG provides an evidence-based framework for evaluating and managing care for patients with chronic pain who are on or who are being considered for prescribed opioids toward improving clinical outcomes. Successful implementation of this CPG will:

Assess the patient’s condition and collaborate with the patient, family, and caregivers to determine optimal management of patient care

Emphasize the use of patient-centered care and shared decision making

Minimize preventable complications and morbidity

Optimize individual health outcomes and quality of life (QoL)

The full VA/DoD Opioids CPG, as well as additional toolkit materials including a pocket card and patient summary, can be found at: https://www.healthquality.va.gov/index.asp.

May 2022 Page 2 of 18

Recommendations

The following evidence-based clinical practice recommendations were made using a systematic approach considering four domains as per the GRADE approach (see Methods). These domains include: confidence in the quality of the evidence, balance of desirable and undesirable outcomes (i.e., benefits and harms), patient values and preferences, and other implications (e.g., resource use, equity, acceptability).

Table 1. Recommendations

Topic Sub-topic # Recommendation Strengtha Categoryb

In iti at io n an d Co nt in ua tio n of

O pi oi ds

1.

We recommend against the initiation of opioid therapy for the management of chronic non-cancer pain (for non-opioid treatments for chronic pain, see the VA/DoD CPGs for Low Back Pain, Headache, and Hip and Knee Osteoarthritis).c

Strong against

Reviewed, New-replaced

2.

We recommend against long-term opioid therapy, particularly for younger age groups, as age is inversely associated with the risk of opioid use disorder and overdose.

Strong against

Reviewed, New-replaced

3.

We recommend against long-term opioid therapy, particularly for patients with chronic pain who have a substance use disorder (refer to the VA/DoD CPG for the Management of Substance Use Disorders).d

Strong against

Reviewed, New-replaced

4.

For patients receiving medication for opioid use disorder, there is insufficient evidence to recommend for or against the selection of any one of the following medications over the other for the management of their co-occurring chronic pain:

methadone, buprenorphine, or extended-release naltrexone injection. Treat the opioid use disorder according to the VA/DoD CPG for the Management of Substance Use Disorders.d

Neither for nor against

Reviewed, New-replaced

5.

For patients receiving daily opioids for the treatment of chronic pain, we suggest the use of buprenorphine instead of full agonist opioids due to lower risk of overdose and misuse.

Weak for Reviewed, New-added

6.

We recommend against the concurrent use of benzodiazepines and opioids for chronic pain (refer to Recommendation 10 in the VA/DoD CPG for the Management of Substance Use Disordersd for further guidance related to tapering one or both agents).

Strong against

Reviewed, Amended

May 2022 Page 3 of 18

Topic Sub-topic # Recommendation Strengtha Categoryb

Do se

, D ur at io n, a nd T ap er o f O pi oi ds

Do se a nd

D ur at io n

7. If prescribing opioids, we recommend using the lowest dose of opioids as indicated by patient-specific risks and benefits. Strong for Reviewed, Amended

8.

If considering an increase in opioid dosage, we recommend reevaluation of patient-specific risks and benefits and monitoring for adverse events including opioid use disorder and risk of overdose with increasing dosage.

Strong for Reviewed, New-replaced

9. When prescribing opioids, we recommend the shortest duration as indicated. Strong for Reviewed, New-replaced

10.

After initiating opioid therapy, we recommend reevaluation at 30 days or fewer and frequent follow-up visits, if opioids are to be continued.

Strong for Reviewed, New-replaced

11.

We recommend against prescribing long-acting opioids:

For acute pain As an as-needed medication When initiating long-term opioid therapy

Strong against

Reviewed, Amended

Ta pe rin g 12. We suggest a collaborative, patient-centered approach to opioid tapering. Weak for Reviewed, New-replaced

13. There is insufficient evidence to recommend for or against any specific tapering strategies.

Neither for nor against

Reviewed, New-replaced

Sc re en in g, A ss es sm en t, an d Ev al ua tio n

14.

We recommend assessing risk of suicide and self-directed violence when initiating, continuing, changing, or discontinuing long-term opioid therapy (refer to the VA/DoD CPG for the Assessment and Management of Patients at Risk for Suicide for guidance on intervention timing and strategies).e

Strong for Reviewed, New-replaced

15.

For patients with chronic pain, we recommend assessing for behavioral health conditions, history of traumatic brain injury, and psychological factors (e.g., negative affect, pain catastrophizing) when considering long-term opioid therapy, as these conditions are associated with a higher risk of harm.

Strong for Reviewed, New-added

16.

For patients with acute pain when opioids are being considered, we suggest screening for pain catastrophizing and co-occurring behavioral health conditions to identify those at higher risk for negative outcomes.

Weak for Reviewed, New-added

17.

For patients on opioids, we suggest ongoing reevaluation of the benefits and harms of continued opioid prescribing based on individual patient risk characteristics.

Weak for Reviewed, New-replaced

Ri sk

M iti ga tio n 18. We suggest urine drug testing for patients on long-term opioids. Weak for Reviewed, New-replaced

19.

We suggest interdisciplinary care that addresses pain and/or behavioral health problems, including substance use disorders, for patients presenting with high risk and/or aberrant behavior.

Weak for Not reviewed, Amended

20.

We suggest providing patients with pre-operative opioid and pain management education to decrease the risk of prolonged opioid use for post-surgical pain.

Weak for Reviewed, New-added a For additional information, see Determining Recommendation Strength and Direction in the full VA/DoD Opioids CPG b For additional information, see Recommendation Categorization and Appendix G in the full VA/DoD Opioids CPG c Other VA/DoD CPGs are available at: https://www.healthquality.va.gov/ d See the VA/DoD CPG for the Management of Substance Use Disorders, available at: https://www.healthquality.va.gov/ e See the VA/DoD CPG for the Assessment and Management of Patients at Risk for Suicide, available at:

https://www.healthquality.va.gov/

May 2022 Page 4 of 18

Algorithm

This CPG’s algorithm is designed to facilitate understanding of the clinical pathway and decision making process used in managing patients prescribed opioids for chronic pain. This algorithm format represents a simplified flow of the use of opioids in the management of chronic pain and helps foster efficient decision making by providers. It includes:

An ordered sequence of steps of care

Decisions to be considered

Recommended decision criteria

Actions to be taken

The algorithm is a step-by-step decision tree. Standardized symbols are used to display each step, and arrows connect the numbered boxes indicating the order in which the steps should be followed.(2) Sidebars provide more detailed information to assist in defining and interpreting elements in the boxes.

Shape Description

Rounded rectangles represent a clinical state or condition

Hexagons represent a decision point in the process of care, formulated as a question that can be answered “Yes” or “No”

Rectangles represent an action in the process of care

Ovals represent a link to another section within the algorithm

For alternative text descriptions of the algorithm, see Appendix J in the full VA/DoD Opioids CPG.

May 2022 Page 5 of 18

Module A: Determination of Appropriateness for Opioids for Chronic Pain

Note: Non-pharmacologic and non-opioid pharmacologic treatments are preferred for chronic pain

* Other VA/DoD CPGs are available here: https://www.healthquality.va.gov/ Abbreviations: CPGs: VA/DoD Clinical Practice Guidelines; LBP: low back pain; OA: osteoarthritis; SUD: substance use disorders

May 2022 Page 6 of 18

Module B: Initiation of Treatment with Opioids

* VA/DoD SUD CPG is available here: https://www.healthquality.va.gov/ Abbreviations: OUD: opioid use disorder; SUD: substance use disorders; VA/DoD SUD CPG: VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders

May 2022 Page 7 of 18

Module C: Maintaining, Tapering, Discontinuing, or Switching from Full Agonist Opioids

* VA/DoD SUD CPG is available here: https://www.healthquality.va.gov/ ** According to the CDC, drug diversion is when prescription medicines are obtained or used illegally.

Abbreviations: MEDD: morphine equivalent daily dose; mg: milligram(s); MOUD: medication for opioid use disorder;

OUD: opioid use disorder; SUD: substance use disorders; VA/DoD SUD CPG: VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders

May 2022 Page 8 of 18

Sidebar A: Components of Pain/Biopsychosocial Assessment Conduct a pain assessment (e.g., information about the onset of pain, location, duration, exacerbating factors, relieving factors, whether there is radiation [location of the radiation and what triggers the radiation], 24 hour pain pattern, quality of pain)

Assess history of previous treatments and effect on pain Assess impact of pain on daily functioning and quality of life (e.g., pain interference, family, education, work, community, social activities, sleep quality) Assess patient’s functional goals Evaluate psychological/behavioral factors, including suicide risk,a that may affect treatment (e.g., pain avoidance, pain catastrophizing) Evaluate social factors that may affect treatment (e.g., employment, homelessness) Assess current and past co-occurring conditions (medical and behavioral health comorbidities) Conduct physical exam Confirm diagnosis (review previous diagnostic studies) Consider consultations and referrals Patient beliefs and understanding of:

The cause of their pain Their treatment preferences The perceived efficacy of various treatment options

For patients already on prescribed opioids, see Module C.

a See the VA/DoD CPG for the Assessment and Management of Patients at Risk for Suicide, available at:

https://www.healthquality.va.gov/

Sidebar B: Non-opioid Treatments for Chronic Pain

Rehabilitation and manipulative therapies (e.g., provided by physical therapists, occupational therapists, chiropractors)

Pharmacologic therapy (e.g., over-the-counter medications, non-opioid prescription pain medications) Interventional procedures (e.g., trigger point injections, joint injections, acupuncture) Psychological and behavioral interventions (e.g., motivational interviewing, CBT) Complementary and integrative treatments (e.g., yoga, tai chi)

Abbreviations: CBT: cognitive behavioral therapy

May 2022 Page 9 of 18

Sidebar C: Opioid Risk Assessment

Examples of contraindications to initiating opioids for chronic pain:

SUD, not in remission Elevated suicide riska

Concomitant use of benzodiazepines

If patient is already on prescribed opioids, is there evidence of OUD, such as:

Self-escalating dose Early refills Difficulty tapering Cravings Continued use despite medical or psychological consequences Interpersonal or social problems related to opioid use

Screening tools and predictive models (repeat as clinically indicated). Examples include:

RIOSORD

STORM

a See the VA/DoD CPG for the Assessment and Management of Patients at Risk for Suicide, available at:

https://www.healthquality.va.gov/

Abbreviations: OUD: opioid use disorder; RIOSORD: Risk Index for Overdose or Serious Opioid-induced Respiratory Depression;

STORM: Stratification Tool for Opioid Risk Mitigation; SUD: substance use disorders

Sidebar D: Consideration Checklist for Prescribing Opioids for Chronic Pain Risks do not outweigh potential functional benefits Patient has a condition that is:

Causing severe chronic pain Interfering with function and quality of life Failing to adequately respond to indicated non-pharmacologic and non-opioid pharmacologic therapy

Clear and measurable functional goals are established Patient is willing and able to access adequate follow-up for prescribed opioids PDMP and UDT are concordant with expectations (no aberrant behavior) Patient is fully informed and consents to treatment with opioids

Abbreviations: PDMP: prescription drug monitoring program; UDT: urine drug testing

Sidebar E: Risk Mitigation Strategies

UDT

PDMP

Informed consent

OEND

Provider follow-up (in-person or video-based) with frequency determined by risk

Abbreviations: OEND: overdose education and naloxone distribution; PDMP: prescription drug monitoring program; UDT: urine drug testing

May 2022 Page 10 of 18

Sidebar F: Considerations for Tapering, Dosage Reduction, and Discontinuation Patient preference Patient characteristics and needs Lack of clinically meaningful improvement in functional goals (review treatment goals at onset of treatment) Concomitant use of medications that increase risk of overdose Co-occurring medical or behavioral health conditions, including SUD, that increase risk Patient non-compliance with opioid safety measures and opioid risk mitigation strategies Patient non-participation in a comprehensive pain care plan Higher dosage which increases risk of adverse events (see Sidebar L) Pain condition not effectively treated with opioids (e.g., back pain with normal MRI; fibromyalgia) Improvement in the underlying pain condition being treated Significant side effects Experiences overdose or other serious adverse events Diversion

Abbreviations: MRI: magnetic resonance imaging

Sidebar G: Factors That May Indicate Need for More Frequent Follow-up Non-adherence to comprehensive pain care plan (e.g., attendance at appointments) Unexpected UDT and PDMP results Non-adherence to opioid prescription (e.g., using more than prescribed and/or running out early) Higher risk medication characteristics (e.g., higher-dose opioids [see Sidebar L], combination of opioids and benzodiazepines) Patients with co-occurring medical and behavioral health conditions, including SUD, that increase risk for adverse outcomes

Abbreviations: PDMP: prescription drug monitoring program; SUD: substance use disorders; UDT: urinary drug testing

Sidebar H: Factors Requiring Immediate Attention and Possible Discontinuation or Switch to Safer Regimen

Untreated SUD Unstable other behavioral health disorder Medical condition that acutely increases opioid risks (e.g., compromised or worsening cognitive or cardiopulmonary status, acute liver or renal disease) Other factors that acutely increase risk of overdose:

Recent overdose Current sedation Concomitant medications (e.g., benzodiazepines) and/or alcohol use

Acutely elevated suicide riska Diversion a See the VA/DoD CPG for the Assessment and Management of Patients at Risk for Suicide, available at:

Abbreviations: SUD: substance use disorders

May 2022 Page 11 of 18

Sidebar I: Considerations During Reassessment Risks Increase in all-cause mortality Increased risk of overdose (including overdose death) Increased risk of developing OUD Risk of developing or worsening:

Depression Falls Fractures Sleep disordered breathing Worsening pain Motor vehicle accidents Hypogonadism Prolonged pain

Nausea Constipation Dry mouth Sedation Cognitive dysfunction Immune system dysfunction Reduction in function Reduction in quality of life

Benefits Modest short-term improvement in pain Possible short-term improvement in function

If risks outweigh benefits, consider tapering, discontinuing, or switching from full agonist opioids (see Module C, Box 36).

Abbreviations: OUD: opioid use disorder

Sidebar J: Tapering Treatment Safety permitting, a gradual taper rate (consider a 5-20% reduction every 4 weeks or longer, adjust or pause as needed) allows time for neurobiological, psychological, and behavioral adaptations Tapering plans should be individualized based on patient goals and concerns, treatment characteristics, and safety considerations The VHA PBM Academic Detailing Service offers example tapers for opioids in their

Opioid Taper Decision Tool: A VA Clinicians Guide. Examples are provided for four taper rates: slowest, slower, fast, and rapid tapers.

When there are concerns regarding risks of tapering (e.g., unmasked OUD, exacerbation of underlying behavioral health conditions), consider interdisciplinary services that may include behavioral health, specialty SUD, primary care, specialty pain care, and complementary and integrative health interventions

Provide patient education to address concerns that may negatively impact taper (e.g., inability for adequate follow-up, inability to provide adequate treatment for co-occurring medical and behavioral health conditions, including SUD, address anxiety concerns)

Patient and treatment characteristics to consider when determining tapering strategy:

Opioid dose Duration of therapy Type of opioid formulation Psychiatric, including SUD, and medical comorbidities Other patient risk factors (e.g., non-adherence, high-risk medication-related behavior, strength of social support, coping) Response/tolerance to prior tapers (e.g., withdrawal symptoms) Level of engagement in non-pharmacologic pain treatments Access to facilities and/or telehealth for monitoring and follow up

Abbreviations: OUD: opioid use disorder; PBM: Pharmacy Benefits Management; SUD: substance use disorders; VHA: Veterans Health Administration

May 2022 Page 12 of 18

Sidebar K: Talking Points for Providers When Recommending Changes to Patients Currently on Opioids

In the context of motivational interviewing and shared decision making:

“Evidence shows that the best treatments for chronic pain are options such as behavioral interventions, rehabilitation therapies, and non-opioid medications.”

“Science has demonstrated that long-term opioid use can lead to multiple problems including loss of pain-relieving effects, increased pain, unintentional death, OUD, and problems with sleep, mood, hormonal dysfunction, and immune dysfunction. I am concerned about your health and safety.”

“While opioids were prescribed to you, we now understand in general that the risks outweigh the benefits when opioids are used long-term. Let's work on reducing your dosage of opioids and discuss other treatment options.”

Abbreviations: OUD: opioid use disorder

Sidebar L: Risks of Prescription Opioid Overdose and Overdose Death at Selected Morphine Equivalent Daily Dose Intervals

Study

Main outcome measure

Expression of risk

MEDD (mg)

0 1 to 19 20 to <50 50 to <100 >100

Turner and Liang (2015)a,e (3)

All overdose AOR

(95% CI) 1 0.80

(0.50-1.27) 1.54

(1.23-1.94) 2.08

(1.61-2.69) 4.34

(3.37-5.57)

Zedler et al.

(2014)a,b,c,e (4) All overdose OR

(95% CI) _ 1 1.5

(1.1-1.9)

2.2 (1.5-3.2)

4.1 (2.6-6.5)

Bohnert et al.

(2011)a,c,f (5)

Unintentional overdose death

HR

(95% CI) _ 1 1.88

(1.33-2.67) 4.63

(3.18-6.74) 7.18

(4.85-10.65)

Bohnert et al.

(2011)b,c,f (5)

Unintentional overdose death

HR

(95% CI) _ 1 1.74

(0.69-4.35) 6.01

(2.29-15.78) 11.99

(4.42-32.56)

Dunn et al.

(2010)a,e (6) All overdose HR

(95% CI)

0.19

(0.05-0.68) 1 1.19 (0.40-3.60)

3.11 (1.01-9.51)

11.18 (4.80-26.03)

Ilgen et al.

(2016)a,c,d (7)

Overdose with suicidal intent

HR

(95% CI) _ 1 1.59

(1.12-2.27) 1.74

(1.09-2.76) 2.09

(1.22-3.56) a Chronic non-cancer pain b Chronic cancer pain c Study conducted in U.S. Veterans d Intentional overdose e Drug overdose per ICD-9-CM codes f Overdose death Abbreviations: AOR: adjusted odds ratio; 95% CI: 95% confidence interval; HR: hazard ratio; MEDD: morphine equivalent daily dose; mg: milligram(s); OR: odds ratio

May 2022 Page 13 of 18

Scope of the CPG

This CPG is based on published clinical evidence and related information available through April 9, 2021.

It is intended to provide general guidance on best evidence-based practices (see Appendix A in the full VA/DoD Opioids CPG for additional information on the evidence review methodology). This CPG is not intended to serve as a standard of care.

This CPG is intended for use by VA and DoD PCPs and other clinicians, including physicians, nurse practitioners, physician assistants, physical therapists, nurses, psychologists, dietitians, pharmacists, social workers, and others, involved in the healthcare team caring for patients prescribed opioids for chronic pain. Additionally, this CPG is intended for community-based clinicians involved in the care of Service Members, Veterans, or beneficiaries prescribed opioids for chronic pain.

The patient population of interest for this CPG is adults who are eligible for care in the VA or DoD healthcare delivery systems and those who receive care from community-based clinicians with chronic pain or acute pain who are on or being considered for prescription opioid therapy. It includes Veterans and Service Members as well as their beneficiaries.

Methods

The methodology used in developing this CPG follows the Guideline for Guidelines, an internal document of the VA/DoD EBPWG updated in January 2019 that outlines procedures for developing and submitting VA/DoD CPGs.(8) The Guideline for Guidelines is available at https://www.healthquality.va.gov/. This CPG also aligns with the National Academy of Medicine’s (NAM) principles of trustworthy CPGs (e.g., explanation of evidence quality and strength, the management of potential conflicts of interest [COI], interdisciplinary stakeholder involvement, use of systematic review [SR], and external review).(9) Appendix A in the full VA/DoD Opioids CPG provides a detailed description of the CPG development methodology.

The Work Group used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to craft each recommendation and determine its strength. Per the GRADE approach, recommendations must be evidence-based and cannot be made based on expert opinion alone. The GRADE approach uses the following four domains to inform the strength of each recommendation:

confidence in the quality of the evidence, balance of desirable and undesirable outcomes, patient values and preferences, other considerations as appropriate (e.g., resource use, equity) (see Determining Recommendation Strength and Direction in the full VA/DoD Opioids CPG).(10)

Using these four domains, the Work Group determined the relative strength of each recommendation (Strong or Weak). The strength of a recommendation is defined as the extent to which one can be confident that the desirable effects of an intervention outweigh its undesirable effects and is based on the framework above, which incorporates the four domains.(11) A Strong recommendation generally indicates High or Moderate confidence in the quality of the available evidence, a clear difference in magnitude between the benefits and harms of an intervention, similar patient values and preferences, and understood influence of other implications (e.g., resource use, feasibility).

May 2022 Page 14 of 18

In some instances, there is insufficient evidence on which to base a recommendation for or against a particular therapy, preventive measure, or other intervention. For example, the systematic evidence review may have found little or no relevant evidence, inconclusive evidence, or conflicting evidence for the intervention. The manner in which this is expressed in the CPG may vary. In such instances, the Work Group may include among its set of recommendations a statement of insufficient evidence for an intervention that may be in common practice even though it is not supported by clinical evidence, and particularly if there may be other risks of continuing its use (e.g., high opportunity cost, misallocation of resources). In other cases, the Work Group may decide to not include this type of statement about an intervention. For example, the Work Group may remain silent where there is an absence of evidence for a rarely used intervention. In other cases, an intervention may have a favorable balance of benefits and harms but may be a standard of care for which no recent evidence has been generated.

Using these elements, the Work Group determines the strength and direction of each recommendation and formulates the recommendation with the general corresponding text (see Table 2).

Table 2. Strength and Direction of Recommendations and General Corresponding Text

Recommendation Strength and Direction General Corresponding Text Strong for We recommend … Weak for We suggest … Neither for nor against There is insufficient evidence to recommend for or against … Weak against We suggest against … Strong against We recommend against …

It is important to note that a recommendation’s strength (i.e., Strong versus Weak) is distinct from its clinical importance (e.g., a Weak recommendation is evidence-based and still important to clinical care).

The strength of each recommendation is shown in the Recommendations section.

The GRADE of each recommendation made in the 2022 CPG can be found in the section on Recommendations. Additional information regarding the use of the GRADE system can be found in Appendix A in the full VA/DoD Opioids CPG.

Recommendation categories were used to track how the previous CPG’s recommendations could be reconciled. These categories and their corresponding definitions are similar to those used by the National Institute for Health and Care Excellence (NICE, England).(12, 13) Table 3 lists these categories, which are based on whether the evidence supporting a recommendation was systematically reviewed, the degree to which the previous CPG’s recommendation was modified, and whether a previous CPG’s recommendation is relevant in the updated CPG.

Additional information regarding these categories and their definitions can be found in Recommendation Categorization the full VA/DoD Opioids CPG. The 2022 CPG recommendation categories can be found in Recommendations. Appendix G in the full VA/DoD Opioids CPG outlines the 2017 VA/DoD Opioids CPG’s recommendation categories.

May 2022 Page 15 of 18

Table 3. Recommendation Categories and Definitionsa

Evidence Reviewed

Recommendation Category Definition

Reviewedb

New-added New recommendation New-replaced Recommendation from previous CPG was carried forward and revised Not changed Recommendation from previous CPG was carried forward but not changed

Amended Recommendation from previous CPG was carried forward with a nominal change

Deleted Recommendation from previous CPG was deleted

Not reviewedc

Not changed Recommendation from previous CPG was carried forward but not changed

Amended Recommendation from previous CPG was carried forward with a nominal change

Deleted Recommendation from previous CPG was deleted a Adapted from the NICE guideline manual (2012) (12) and Garcia et al. (2014) (13) b The topic of this recommendation was covered in the evidence review carried out as part of the development of the current CPG.

c The topic of this recommendation was not covered in the evidence review carried out as part of the development of the current CPG.

Abbreviation: CPG: clinical practice guideline

Guideline Work Group

Table 4. Guideline Work Group and Guideline Development Team

Organization Names*

Department of Veterans Affairs

Jennifer Murphy, PhD (Champion) Friedhelm Sandbrink, MD (Champion) Jamie Clinton-Lont, AGPCNP-BC Ellen L. Edens, MD, MPE Franz Macedo, DO Mitchell Nazario, PharmD Juli Olson, DC, DACM Sanjog Pangarkar, MD Matthew Prince, PT, DPT, OCS Donna Endsley Real, MPH, LCSW

Department of Defense

CDR Melanie Johansson, MD, FACEP (Champion) Christopher Spevak, MD, MPH, JD (Champion) MAJ Nicole H. Brown, DPT, OCS, SCS, FPS Kathryn Gillespie, MSN, JD, RN, CNL MAJ Raquel Giunta, PharmD, BCPS COL Samuel Preston, DO CAPT David Riegleman, MD Evan Steil, MD, MBA, MHA, FAAFP

VA Evidence Based Practice, Office of Quality and Patient Safety Veterans Health Administration

M. Eric Rodgers, PhD, FNP-BC James Sall, PhD, FNP-BC Rene Sutton, BS, HCA

May 2022 Page 16 of 18

Organization Names*

Clinical Quality Improvement Program Defense Health Agency

Kathryn Gillespie, MSN, JD, RN, CNL

The Lewin Group

Clifford Goodman, PhD Erika Beam, MS Ben Agatston, JD, MPH Charlie Zachariades, MSc Andrea Dressel, BS Estee Welo, BA

ECRI

James Reston, PhD, MPH Kelley Tipton, MPH Allison Hedden-Gross, MS, MLS

Sigma Health Consulting Frances Murphy, MD, MPH James Smirniotopoulos, MD

Duty First Consulting

Mary Kate Curley, BA Kate Johnson, BA Rachel Piccolino, BA Richa Ruwala, BA

*Additional contributor contact information is available in Appendix H in the full VA/DoD Opioids CPG.

Patient-centered Care

Guideline recommendations are intended to consider patient needs and preferences. Guideline recommendations represent a whole/holistic health approach to care that is patient-centered, culturally appropriate, and available to people with limited literacy skills and physical, sensory, or learning disabilities. VA/DoD CPGs encourage providers to use a patient-centered, whole/holistic health approach (i.e., individualized treatment based on patient needs, characteristics, and preferences). This approach aims to treat the particular condition while also optimizing the individual’s overall health and well-being.

Regardless of the care setting, all patients should have access to individualized evidence-based care.

Patient-centered care can decrease patient anxiety, increase trust in clinicians, and improve treatment adherence.(14, 15) A whole/holistic health approach (https://www.va.gov/wholehealth/) empowers and equips individuals to meet their personal health and well-being goals. Good communication is essential and should be supported by evidence-based information tailored to each patient’s needs. An empathetic and non-judgmental approach facilitates discussions sensitive to gender, culture, ethnicity, and other differences.

Shared Decision Making

This CPG encourages providers to practice shared decision making, which is a process in which providers and patients consider clinical evidence of benefits and risks as well as patient values and preferences to make decisions regarding the patient’s treatment.(16) Shared decision making was emphasized in Crossing the Quality Chasm, an Institute of Medicine (IOM) (now NAM) report in 2001 (17) and is

May 2022 Page 17 of 18 inherent within the whole/holistic health approach. Providers must be adept at presenting information to their patients regarding individual treatments, expected risks, expected outcomes, and levels and/or settings of care, especially where there may be patient heterogeneity in risks and benefits. The VHA and MHS have embraced shared decision making. Providers are encouraged to use shared decision making to individualize treatment goals and plans based on patient capabilities, needs, and preferences.

Patients with Co-occurring Conditions

Co-occurring conditions can modify the degree of risk, impact diagnosis, influence patient and provider treatment priorities and clinical decisions, and affect the overall approach to the use of opioids in the management of chronic pain. Many Veterans, Service Members, and their families have one or more co-occurring conditions. Because chronic pain is sometimes accompanied by co-occurring conditions, it is often best to make decisions about use of opioids in the management of chronic pain collaboratively with other care providers. Some co-occurring conditions may require early specialist consultation to determine any necessary changes in treatment or to establish a common understanding of how care will be coordinated. This may entail reference to other VA/DoD CPGs (e.g., for Major Depressive Disorder [MDD], SUD, and Suicide1).

1 Other VA/DoD CPGs are available at: https://www.healthquality.va.gov/

May 2022 Page 18 of 18

References

1. U.S. Department of Veterans Affairs/Department of Defense Health Executive Committee (HEC). Evidence Based Practice Work Group Charter [Updated January 9, 2017]. Available from: www.healthquality.

va.gov/documents/EvidenceBasedPracticeWGCharter123020161.pdf.

2. Society for Medical Decision Making Committee on Standardization of Clinical Algorithms. Proposal for clinical algorithm standards. Medical decision making: an international journal of the Society for Medical Decision Making. 1992;12(2):149-54. Epub 1992/04/01. PubMed PMID: 1573982.

3. Turner BJ, Liang Y. Drug overdose in a retrospective cohort with non-cancer pain treated with opioids, antidepressants, and/or sedative-hypnotics: Interactions with mental health disorders. Journal of general internal medicine. 2015;30(8):1081-96.

4. Zedler B, Xie L, Wang L, Joyce A, Vick C, Kariburyo F, et al. Risk factors for serious prescription opioid-related toxicity or overdose among Veterans Health Administration patients. Pain medicine. 2014;15(11):1911-29.

5. Bohnert AS, Valenstein M, Bair MJ, Ganoczy D, McCarthy JF, Ilgen MA, et al. Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA. 2011;305(13):1315-21.

6. Dunn KM, Saunders KW, Rutter CM, Banta-Green CJ, Merrill JO, Sullivan MD, et al. Opioid prescriptions for chronic pain and overdose: a cohort study. Annals of internal medicine. 2010;152(2):85-92.

7. Ilgen MA, Bohnert AS, Ganoczy D, Bair MJ, McCarthy JF, Blow FC. Opioid dose and risk of suicide. Pain.

2016;157(5):1079.

8. U.S. Department of Veteran Affairs, Department of Defense. Guideline for Guidelines: Veterans Health Administration, Office of Quality & Performance, Evidence Review Subgroup; updated January 29, 2019.

Available from: http://www.healthquality.va.gov/policy/index.asp.

9. Ransohoff DF, Pignone M, Sox HC. How to decide whether a clinical practice guideline is trustworthy. JAMA.

2013;309(2):139-40. Epub 2013/01/10. doi: 10.1001/jama.2012.156703. PubMed PMID: 23299601.

10. Andrews JC, Schunemann HJ, Oxman AD, Pottie K, Meerpohl JJ, Coello PA, et al. GRADE guidelines: 15.

Going from evidence to recommendation-determinants of a recommendation's direction and strength.

Journal of clinical epidemiology. 2013;66(7):726-35. Epub 2013/04/11. doi: 10.1016/j.jclinepi.2013.02.003.

PubMed PMID: 23570745.

11. Andrews J, Guyatt G, Oxman AD, Alderson P, Dahm P, Falck-Ytter Y, et al. GRADE guidelines: 14. Going from evidence to recommendations: the significance and presentation of recommendations. Journal of clinical epidemiology. 2013;66(7):719-25. Epub 2013/01/15. doi: 10.1016/j.jclinepi.2012.03.013. PubMed

PMID: 23312392.

12. National Institute for Health and Care Excellence. The guidelines manual. London: National Institute for Health and Care Excellence, 2012.

13. Martinez Garcia L, McFarlane E, Barnes S, Sanabria AJ, Alonso-Coello P, Alderson P. Updated recommendations: an assessment of NICE clinical guidelines. Implementation science : IS. 2014;9:72.

Epub 2014/06/13. doi: 10.1186/1748-5908-9-72. PubMed Central PMCID: PMC4067507.

14. Robinson JH, Callister LC, Berry JA, Dearing KA. Patient-centered care and adherence: Definitions and applications to improve outcomes. Journal of the American Academy of Nurse Practitioners. 2008;20(12):

600-7. Epub 2009/01/06. doi: 10.1111/j.1745-7599.2008.00360.x. PubMed PMID: 19120591.

15. Stewart M, Brown JB, Donner A, McWhinney IR, Oates J, Weston WW, et al. The impact of patient-centered care on outcomes. J Fam Pract. 2000;49(9):796-804. Epub 2000/10/14. PubMed PMID: 11032203.

16. National Learning Consortium. Shared Decision Making 2013. Available from:

https://www.healthit.gov/sites/default/files/nlc_shared_decision_making_fact_sheet.pdf.

17. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century.

Washington, DC: National Academies Press, 2001.

Access to the full guideline and additional resources are available at the following link:

/ASCII85EncodePages false /AllowTransparency false /AutoPositionEPSFiles true /AutoRotatePages /None /Binding /Left /CalGrayProfile (Dot Gain 20%) /CalRGBProfile (sRGB IEC61966-2.1) /CalCMYKProfile (U.S. Web Coated \050SWOP\051 v2) /sRGBProfile (sRGB IEC61966-2.1) /CannotEmbedFontPolicy /Error /CompatibilityLevel 1.4 /CompressObjects /Tags /CompressPages true /ConvertImagesToIndexed true /PassThroughJPEGImages true /CreateJobTicket false /DefaultRenderingIntent /Default /DetectBlends true /DetectCurves 0.0000 /ColorConversionStrategy /CMYK /DoThumbnails false /EmbedAllFonts true /EmbedOpenType false /ParseICCProfilesInComments true /EmbedJobOptions true /DSCReportingLevel 0 /EmitDSCWarnings false /EndPage -1 /ImageMemory 1048576 /LockDistillerParams false /MaxSubsetPct 100 /Optimize true

/OPM 1

/ParseDSCComments true /ParseDSCCommentsForDocInfo true /PreserveCopyPage true /PreserveDICMYKValues true /PreserveEPSInfo true /PreserveFlatness true /PreserveHalftoneInfo false /PreserveOPIComments true /PreserveOverprintSettings true /StartPage 1 /SubsetFonts true /TransferFunctionInfo /Apply /UCRandBGInfo /Preserve /UsePrologue false /ColorSettingsFile () /AlwaysEmbed [ true /NeverEmbed [ true /AntiAliasColorImages false /CropColorImages true /ColorImageMinResolution 300 /ColorImageMinResolutionPolicy /OK /DownsampleColorImages true /ColorImageDownsampleType /Bicubic /ColorImageResolution 300 /ColorImageDepth -1 /ColorImageMinDownsampleDepth 1 /ColorImageDownsampleThreshold 1.50000 /EncodeColorImages true /ColorImageFilter /DCTEncode /AutoFilterColorImages true /ColorImageAutoFilterStrategy /JPEG /ColorACSImageDict << /QFactor 0.15 /HSamples [1 1 1 1] /VSamples [1 1 1 1] /ColorImageDict << /QFactor 0.15 /HSamples [1 1 1 1] /VSamples [1 1 1 1] /JPEG2000ColorACSImageDict << /TileWidth 256 /TileHeight 256 /Quality 30 /JPEG2000ColorImageDict << /TileWidth 256 /TileHeight 256 /Quality 30 /AntiAliasGrayImages false /CropGrayImages true /GrayImageMinResolution 300 /GrayImageMinResolutionPolicy /OK /DownsampleGrayImages true /GrayImageDownsampleType /Bicubic /GrayImageResolution 300 /GrayImageDepth -1 /GrayImageMinDownsampleDepth 2 /GrayImageDownsampleThreshold 1.50000 /EncodeGrayImages true /GrayImageFilter /DCTEncode /AutoFilterGrayImages true /GrayImageAutoFilterStrategy /JPEG /GrayACSImageDict << /QFactor 0.15 /HSamples [1 1 1 1] /VSamples [1 1 1 1] /GrayImageDict << /QFactor 0.15 /HSamples [1 1 1 1] /VSamples [1 1 1 1] /JPEG2000GrayACSImageDict << /TileWidth 256 /TileHeight 256 /Quality 30 /JPEG2000GrayImageDict << /TileWidth 256 /TileHeight 256 /Quality 30 /AntiAliasMonoImages false /CropMonoImages true /MonoImageMinResolution 1200 /MonoImageMinResolutionPolicy /OK /DownsampleMonoImages true /MonoImageDownsampleType /Bicubic /MonoImageResolution 1200 /MonoImageDepth -1 /MonoImageDownsampleThreshold 1.50000 /EncodeMonoImages true /MonoImageFilter /CCITTFaxEncode /MonoImageDict << /K -1 /AllowPSXObjects false /CheckCompliance [ /None /PDFX1aCheck false /PDFX3Check false /PDFXCompliantPDFOnly false /PDFXNoTrimBoxError true /PDFXTrimBoxToMediaBoxOffset [ 0.00000 0.00000 0.00000 0.00000 /PDFXSetBleedBoxToMediaBox true /PDFXBleedBoxToTrimBoxOffset [ 0.00000 0.00000 0.00000 0.00000 /PDFXOutputIntentProfile () /PDFXOutputConditionIdentifier () /PDFXOutputCondition () /PDFXRegistryName () /PDFXTrapped /False

/CreateJDFFile false…