1. Guideline Development Societal needs have driven guideline development to the forefront: – Aid physician education on new clinical information – Set research priorities-identify knowledge gaps – Decrease practice variations – Monitor inappropriate care – Promote better health care outcomes – Slow the rising cost of health care William C. Watters, III, MD

2. Guideline Development Thus guideline development has taken on goals beyond those of communicating recent advances in care – Promotion of measurable health care quality, appropriateness, and effectiveness – Maintenance of access to care through both education and cost containment – Identification of gaps in clinical knowledge

3. Guideline Development The role of evidence-based medicine in guideline development is to formalize the process and make it transparent: – Provide valid recommendations based on a critical appraisal of the best available evidence (Best Practices Model) – Minimize the use of informal, opinion-based recommendations

4. Guideline Development “A formal method of guideline development creates an explicit linkage between the final recommendations and the evidence on which they are based.” J E Heffner, Chest, 1998

5. Attributes of Systematically Developed Guidelines Validity: How closely is the guideline linked to the available evidence? Reliability: Would a different group of developers derive similar guidelines with the same evidence? Reproducibility: Would different care-givers interpret and apply the guidelines similarly in similar contexts

6. Attributes of Systematically Developed Guidelines Applicability: Is the guideline specific as to the populations and clinical situations to which it applies? Flexibility: Does the guideline accommodate the use of the clinician’s experience and allow tailoring to the individual patient’s needs and values?

7. Attributes of Systematically Developed Guidelines Clarity: Are the guidelines unambiguous and precise? Documentation: Is the method of development transparent and clearly stated? Multidisciplinary: Did the developers represent more than one clinical orientation towards the clinical problems being addressed?

8. Evidence and Consensus 1. Demarcates limits of evidence & knowledge 2. Points out research opportunities 3. Avoids over-stating guideline recommendations 4. Promotes clinical flexibility within the guideline

9. Consensus Thus, prior to guideline development: – Consensus must be defined (majority, two thirds of members, etc) – Technique to be utilized to arrive at a consensus must identified and used consistently (Delphi techniques, evidence juries, etc) – Commitment made to clearly state both and where they were used in the final guideline

10. Consensus Expert opinion and consensus enter into the guideline development process in at least 4 ways: – Choosing the clinical questions to be investigated – Rating the evidence – Assessing the value and applicability of the evidence – Filling in the knowledge gaps

11. Guideline Development 1. Quality, effectiveness and appropriateness of patient care will improve 2. Access to quality care will improve 3. Knowledge gaps will be identified indicating where expert judgment is needed and further research required

12. GRAPPA Guidelines for PsA: Considerations GRAPPA Guidelines Mission Statement: “To develop guidelines, based upon the best scientific evidence, for the optimal treatment of patients with psoriatic arthritis (PsA).” Guidelines: “Systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances” IOM More data needed on prognostic factors (e.g.for peripheral arthritis, oligoarticular vs polyarticular; erosive vs non-erosive, +/- other features such as axial, skin, entheses, etc) to optimize stratification PsA multifaceted: To start, we can begin with a base case of a patient with peripheral arthritis How appropriate is extrapolation of efficacy/safety data, and hence treatment guidelines, from similar conditions (psoriasis, AS, RA, etc)? Can we borrow aspects of screening, stratification, monitoring? Determine most appropriate outcome measures (signs/symptoms, structural integrity, QOL/functional status) Guideline exigency driven by introduction of novel immunomodulatory therapies, and their expense; with sensitivity to local factors, cultural differences, economics, etc

13. GRAPPA Guidelines for PsA: Considerations GRAPPA Guidelines Mission Statement: “To develop guidelines, based upon the best scientific evidence, for the optimal treatment of patients with psoriatic arthritis (PsA).” Guidelines: “Systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances” IOM More data needed on prognostic factors (e.g.for peripheral arthritis, oligoarticular vs polyarticular; erosive vs non-erosive, +/- other features such as axial, skin, entheses, etc) to optimize stratification PsA multifaceted: To start, we can begin with a base case of a patient with peripheral arthritis How appropriate is extrapolation of efficacy/safety data, and hence treatment guidelines, from similar conditions (psoriasis, AS, RA, etc)? Can we borrow aspects of screening, stratification, monitoring? Determine most appropriate outcome measures (signs/symptoms, structural integrity, QOL/functional status) Guideline exigency driven by introduction of novel immunomodulatory therapies, and their expense; with sensitivity to local factors, cultural differences, economics, etc

14. If Guidelines Are Based on Best Available Evidence, How Do We Handle: When “state of the art” outstrips peer-reviewed published medical literature? That quality of newer studies is superior to older studies? The variable diagnostic criteria / outcomes in trials? Absence of studies for certain therapies (e.g. steroids)? The absence of head-to-head trials? Aphorism: “The absence of evidence of an effect is not equivalent to evidence of absence of an effect” (e.g. MTX When there is no data, what is the role of “expert” opinion? How can treatment approaches to divergent aspects of PsA (skin, joints, enthesitis, dactylitis, spondylitis) with various levels of activity) be optimally synthesized? GRAPPA PsA Treatment Guidelines

15. GRAPPA PsA Treatment Guidelines Establish Diagnosis of Psoriatic Arthritis Reassess Response to Therapy and Toxicity Initiate Therapy NSAID PT Biologics (anti-TNF) Axial Disease Peripheral Arthritis Initiate Therapy NSAIDs, IA steroids, DMARDs (MTX, CsA, SSZ, LEF), Biologics (anti-TNF) Skin and Nail Disease Initiate Therapy Topicals PUVA/UVB DMARDs (MTX,CsA,etc) Biologics (anti-TNF, etc) Dactylitis Initiate Therapy NSAID Injection Biologics (anti-TNF) Enthesitis Initiate Therapy NSAID Injection Biologics (anti-TNF)

16. PsA Treatment Guidelines Proposal Committees Systematic Reviews Peripheral arthritis Skin & Nails Axial Dx Dactylitis Enthesitis Guideline development and consensus by committees and patients Vote by GRAPPA

17. Committees Peripheral Arthritis –E. Soriano, N. Mchugh Skin & Nails –A. Kavanaugh, H. Boehneke, A. Gottlieb, B. Strober Axial –P. Nash. J. Zochling Dactylitis –P. Helliwell Enthesitis –C. Ritchlin

18. Treatment Guideline Model Peripheral arthritis (# joints, pain, function, location) + skin and/or nails (severity. location, QOL) + axial disease (pain, function, QOL) + dactylitis (pain, location, function) + enthesitis (pain, location, function)

19. Peripheral ArthritisSki n EnthesitisDactylitisSpine Mild  1-3 tender and/or swollen joints  No erosive disease on plain film  Function not significantly impaired <3% BSA None None  No sign or symptoms of spinal inflammation  Normal Schoeber score and normal AP pelvis form Moderat e  5+ tender/swollen joints  Normal x-rays but Oligoarticularor polyarticular disease that interferes w/ normal function  Or less than 5 T/S joints but with erosions or JSN on x-ray >3% And <10 % BSA 1-3 entheseal sites inflamed 1-3 inflamed digits Inflammatory back pain with a normal AP pelvis film Severe  >5 tender /swollen joints w/ evidence of joint damage on exam  Arthritis mutilans  Oligo-or polyarticular disease that limits ADLs >10 % BSA  >3 sites  Entheseal involvement in foot that prevents ambulation  Tendon rupture  >3 inflamed digits  Evidenc e of ankylosis in a dactylitic joint Symptomatic inflammatory back pain with radiographic changes on plain film

20. Evidence based? treatment algorithm for Peripheral PsA PolyarthritisOligoarthritisMonoarthritis Early DMARDs SSZ (A); LFN (A); MTX (B), CyA (B) NSAIDs (A) +/- IA corticosteroids (D) Respond Anti TNF alpha ? Positive Response Failed Response ? Adequate therapeutic trial of 2 DMARDs ?