Implementing Patient Monitoring and Data Collection in Routine Care NYU Hospital for Joint Diseases Arthritis Registry Monitoring Database (ARMD)

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Implementing Patient Monitoring and Data
Collection in Routine CareNYU Hospital for
Joint Diseases Arthritis Registry Monitoring
Database (ARMD) Brooklyn Outcomes of Arthritis
Registry Database (BOARD)

• Yusuf Yazici, MD
• NYU Hospital for Joint Diseases

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Monitoring outcomes in routine care

• Why?
• What do we do now?
• How can we do it?
• Our experience
• Private practice
• Academic center

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Tight control of disease activity TICORA study
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Grigor et al, Lancet 2004
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Monitoring RA patients

• How do rheumatologists follow patients?
• In the US, lt 10 use questionnaires in routine
  clinical care
• lt15 do a joint count at each visit
• Treatment decisions made on ESR/CRP values,
  x-rays?
• At initial presentation,
• 40 of patients have normal ESR or CRP, 30
  have no RF, and the best treatment is before
  X-ray damage.

Pincus, Segurado. Ann Rheum Dis 2006
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Measurement

• Most rheumatologists suggest they can recognize
  extent of pain and disability without
  questionnaires to provide quantitative data
• They are correct
• You can also recognize fever or tachycardia
  without formally measuring temperature or heart
  rate
• Who would accept this kind of management?

Pincus, Yazici, Bergman, J Rheumatol 2006
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Other diseases

• HTN Blood pressure
• Hyperlipidemia - Cholesterol
• Thyroid - TSH
• What does the rheumatologist have?

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VAS clustering
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Pincus T, Sokka T. Ann Rheum Dis 2004
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Questionnaires for standard care must be

• Completed by most patients in 5-10 minutes
• Scanned by a clinician in 5-10 seconds
• Designed to facilitate scoring, template on
  questionnaire
• Scored and entered into flow sheet in 10-20
  seconds
• Informative for patients in all rheumatic
  diseases
• All the work done by the patient physician or
  staff do minimal work, spend few seconds.

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MDHAQMulti-Dimensional Health Assessment
Questionnaire

• 10 ADL overcome floor effects normal scores in
  688 patients MHAQ 23, HAQ 15, MDHAQ 7
• Review of systems
• Distributed at each YY visit of each patient
  since 2001
• Useful in all rheumatic diseases
• Used in conjunction with simple flow sheet - 3
  types of data questionnaire scores, lab data,
  drugs

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Time to score
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Practical considerations in use of MDHAQ, patient
questionnaires (1)

• Use a questionnaire designed for standard care,
  not for research
• Although the information is often useful for
  research
• Just as differences between antiCCP measurement
  in clinical care and research differ, no need for
  lengthy research questionnaires
• Orient staff regarding the importance of patient
  questionnaires in patients care, and mean it
• If rationale presented as for research,
  documentation, reimbursement, collaboration with
  colleagues, any other reason than better and more
  efficient patient care, it wont work

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Practical considerations in use of MDHAQ (2)

• Questionnaires should be part of office
  infrastructure, completed by every patient, with
  any diagnosis, every visit.
• Only efficient distribution system
• Impossible to organize front desk to identify
  patient, identify intervals for questionnaire
  distribution
• MDHAQ is useful for all patients with all
  rheumatic diseases
• Data only at periodic intervals may miss
  important changes
• If there is a reason for a visit, there is a
  reason for a questionnaire

Callahan et al. Arthritis Care Res 1989
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Practical considerations in use of MDHAQ (3)

• Questionnaires should ideally be completed in the
  waiting room, not the exam room
• Most patients spend 10 minutes in the waiting
  room
• An opportunity for the patient to focus on
  problems
• Let the patients do the work office staff should
  do as little as possible
• Function, pain, fatigue, global status are
  reported more accurately by patient self report
  than physicians1
• Only a single observer v second observer
• Reproducibility increased2

1 Fries et al, AR 1980, 2Callahan 1988,
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Practical considerations in use of MDHAQ (4)

• Clinician should review the questionnaire with
  the patient
• Most factual information that would require QA
  is eyeballed in 5 seconds
• Scoring template on the questionnaire
• RAPID, 0-10 VAS, 0-3, or 0-10 function
• Flow sheets can be very useful
• Entry into a flow sheet allows for tracking trend
• Database output
• No computer is required do not overuse
  technology
• Nothing is as cheap, available, and easy to use
  as pen/pencil and paper

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Practical considerations in use of MDHAQ (5)
Constant (Required) Variable (Encouraged) Variable (optional)
Physical function Psychological distress Review of systems
Pain Fatigue Medications
Patient global Change in status Recent medical events
AM stiffness Physician global
RADAI self-report joint count Physician note
MD joint count
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Things to remember

• Data may be influenced by nonspecific factors
• So is ESR, so is pain
• MDHAQ never replaces a careful history and
  physical examination, data always need to be
  interpreted
• All data needs to be put into perspective

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Patient Questionnaires

• Most informative quantitative data for patient
  status from one visit to the next
• Patient questionnaires not a joint count,
  radiographic score or laboratory test are the
  most significant predictors of all severe
  long-term outcomes in RA
• Functional status1
• Work disability2
• Costs3
• Joint replacement surgery4
• Premature death5

1 Pincus et al, AR 1984 2 Sokka et al, J
Rheumatol 1999 3 Luback et al, AR 1986, 4
Wolfe et al, AR 1998, 5 Sokka et al, Ann Rheum
Dis 2004
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Patientreported outcomes
Strand et al, Rheumatology 2004
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Indices
DAS28 SDAI CDAI GAS RAPID ACR20
Swollen joints
Tender joints
MD global
ESR/CRP
Patient global
Functional score
Pain
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Routine care

• Why collect data?

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Randomized Controlled Clinical Trials

• 1. Foundation for evaluation of therapies
• 2. Meet criteria for scientific experiment
• 3. Only method for study patients not selected
  for therapies
• 4. Nonetheless, includes many limitations, and
  provides only the first stage of evaluation of
  therapies

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Some Practical Limitations of Randomized Clinical
Trials

• Patient selection exclusion criteria
• only a small minority in trials, e.g., RA in 2001
• Statistically significant results not necessarily
  clinically important, e.g., ?ACR 20 response
• Short observation period in chronic diseases
• Inflexible dosage schedules and other drugs
• Surrogate markers not necessarily clinically
  relevant

Pincus and Stein. Clin Exp Rheumatol. 199715S27
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real world patients

• Most patients receiving routine care for
  rheumatoid arthritis in 2001 did not meet
  inclusion criteria for most recent clinical
  trials or American college of rheumatology
  criteria for remission. Sokka T, Pincus T. J
  Rheumatol. 2003 Jun30(6)1138-46 11
• Eligibility of patients in routine care for major
  clinical trials of anti-tumor necrosis factor
  alpha agents in rheumatoid arthritis. Sokka T,
  Pincus T. Arthritis Rheum. 2003 Feb48(2)313-8.
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• Eligibility for inclusion criteria in use for
  rheumatoid arthritis clinical trials in a Turkish
  cohort. F. Gögüs, Y. Yazici, H Yazici (ACR 2003)
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• Majority of rheumatoid arthritis (RA) patients in
  routine care do not meet inclusion criteria for
  RA clinical trials. I. Kulman, Y. Yazici (EULAR
  2004) 5

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BOARD

• Brooklyn Outcomes of Arthritis Registry Database

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Brooklyn Outcomes of Arthritis Registry Database
(BOARD)

• Since April 2001
• 2200 patients
• 200 RA
• 150 SLE
• A lot of OA
• gt19,000 data points (visits)

Yazici, Clin Expr Rheumatol, 2005
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BOARD
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BOARD
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BOARD Publications

• Racial/ethnic differences among early RA patients
• Use of ESR/CRP and correlation with outcomes in
  RA, SLE, OA patients
• MTX efficacy and side effects in RA patients
• RAPID/DAS28/CDAI correlation among RA patients

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162 RA patients from BOARD
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HJD ARMD

• Arthritis Registry Monitoring Database

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ARMD

• September 2005 at NYU-Hospital for Joint Diseases
  
• Each patient multidimensional health assessment
  questionnaire
• functional status
• pain
• fatigue
• patient global assessment of disease activity
• RADAI patient self joint count
• morning stiffness
• questions about current medications
• work status
• medical and surgical problems since last visit
• 60-question symptoms list
• comorbitidies
• exercise habits
• demographic information.
• English and Spanish.

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ARMD (2)

• September 2005 to January 2006, 513 patients were
  enrolled,
• 344 from the hospital clinics
• 169 from private offices
• 400 (78) female
• 253 (49) Hispanic (white104, African
  American52, Asian34, others70).
• Mean age was 53 15.
• 374 patients used the English version of the
  forms (73).
• The most common 3 diagnosis were rheumatoid
  arthritis (n235), osteoarthritis (n47) and SLE
  (n25).
• When individual items were analyzed, the
  completion rate ranged from 88 (current
  medications) to 99 (MDHAQ).

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QUEST-RA (Quantitative Patient Questionnaire
Monitoring in Standard Clinical Care of Patients
with Rheumatoid Arthritis)

• 30 rheumatology practices
• 100 RA patients each
• 3000 RA patients
• 1st phase cross-sectional
• 2nd phase longitudinal
• Database creation

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Conclusion A conclusion is the place where
you got tired ofthinking. Arthur Block

• We need to use tools to monitor our patients in
  routine care
• Better medical care, valuable data
• Saves time, focuses visits
• Saves time!

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Questions?

• I do not object to people looking at their
  watches
• when I am speaking.
• But I strongly object when they start shaking
  them to make certain they are still going.
• Lord Birkett, Observer, Sayings of the Week,
  30 October, 1960

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• We become confident in our educated guesswork
  to the point where it is easy to confuse personal
  opinion with evidence, or personal ignorance with
  scientific uncertainty
• David Naylor, M.D., Ph.D. (1954-)