PATIENT EDUCATION in ANKYLOSING SPONDYLITIS Methodological issues

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PATIENT EDUCATION in ANKYLOSING SPONDYLITIS -
Methodological issues

• Laure Gossec, Maxime Dougados January 2004

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• Introduction
• Education in AS literature review-methods and
  results
• ASAS survey-methods and results
• Methodology of education
• Why?
• Study design
• Study treatment variability
• Concomitant treatment
• Evaluation criteria
• Preliminary points to consider for methodology

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• Introduction
• Education in AS literature review-methods and
  results
• ASAS survey-methods and results
• Methodology of education
• Why?
• Study design
• Study treatment variability
• Concomitant treatment
• Evaluation criteria
• Preliminary points to consider for methodology

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Introduction (1/5) Education versus information
Education acquisition of information, technical
skills, beliefs and attitudes which impact on
health status
Biomedical model
knowledge
patient
Health professional
instruments
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Introduction (1/5) Education versus information
Education acquisition of information, technical
skills, beliefs and attitudes which impact on
health status
Biomedical model

• Patient education approach

knowledge
patient
Health professional
instruments
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Introduction (2/5) Health education versus
patient education

• Health education PREVENTING disease enhancing
  health
• Patient education TREATING disease planned,
  organized learning experiences, separate from
  clinical care, designed to facilitate voluntary
  adoption of behaviours or beliefs conducive to
  health. Burckhardt, NAAB, 94

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Introduction (3/5) Who should be educated?

• Patients
• Others in the patients network partners, family
  members
• Health professionals

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Introduction (4/5) Self-management education

• Self-management education
• problem-solving skills,
• decision-making,
• confidence-building
• Self-efficacy confidence in the ability to
  perform a specific behaviour Lorig.

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Introduction (5/5) Objectives of education

• In chronic disease, the patient is the principal
  care-giver.
• Prepare patients for their tasks
• Using medications properly
• Changing behaviours to improve symptoms or slow
  disease progression
• Interpreting and reporting symptoms accurately
• Adjusting to new social and economic
  circumstances
• Coping with emotional consequences, self-efficacy
• Participating in decisions concerning treatment
• Holman and Lorig, Arthr Rheum 97

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• Introduction
• Education in AS literature review-methods and
  results
• ASAS survey-methods and results
• Methodology of education
• Why?
• Study design
• Study treatment variability
• Concomitant treatment
• Evaluation criteria
• Preliminary points to consider for methodology

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Systematic literature review (1/3) Methods

• PUBMED SEARCH
• KEY WORDS
• Ankylosing spondylitis OR spondyloarthopathy
  AND patient education OR patient education
  handout
• AND methodology
• LIMITS
• English
• Study type randomized controlled trial OR
  clinical trial OR all types

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Systematic literature review (2/3) Results
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Systematic literature review (3/3)
Gross, Patient Couns Health Educ 81Group
education, RCT knowledge, trend towards more
compliance with exercise and better coping. No
effects expressed. Basler, Patient Educ Couns
93 Group cognitive-behav. AS and other
diseases. Pain reduction, well-being. Kraag,
JR 90, follow-up 94One-to-one education and
explanation of home physiotherapy RCT, 4 months
and 8 months. on finger-to-floor
distance. Barlow, Patient Educ Couns 96Group
education, self-management self-efficacy,
depression at 6 months, no effects on compliance
with exercise. Sweeney, JR 2002 Video
booklet exercise chart, RCT, 6 months, 200
patients. self-efficacy for exercise,
self-reported exercise, trend for BASFI.
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• Introduction
• Education in AS literature review-methods and
  results
• Results of the ASAS survey
• Methodology of education
• Why?
• Study design
• Study treatment variability
• Concomitant treatment
• Evaluation criteria
• Preliminary points to consider for methodology

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ASAS survey (1/3) methods

• Questionnaire sent to all ASAS members by email
• Evaluation of knowledge of the ASAS members of
  existing education programs in AS individual or
  group
• Evaluation of the opinion of ASAS members on
  the relative weight of 14 domains in an education
  program in AS (scored 0-10)

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ASAS survey (2/3) 40 answers
YES
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ASAS survey (3/3) ideal content of education
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• Introduction
• Education in AS literature review-methods and
  results
• Results of the ASAS survey
• Methodology of education
• Why?
• Study design
• Study treatment variability
• Concomitant treatment
• Evaluation criteria
• Preliminary points to consider for methodology

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Methodology Why? (1/2)

• Patient education little published, frequently
  used.
• Like other treatments, it should be viewed in
  terms of
• effectiveness
• and possible side effects,
• and through methods as stringent as for other
  treatments.

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Methodology Why? (2/2)

• Published data results are mitigatede.g. in
  RA, small short term effects on disability, joint
  counts, patient global assessment and depression
  no evidence of long term benefits Riemsma,
  Cochrane, 2003.
• Methodological difficulties in all
  non-pharmacological treatments Boutron, JAMA
  2003 literature review in knee osteoarthritis,
  110 articles.

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• Introduction
• Education in AS literature review-methods and
  results
• Results of the ASAS survey
• Methodology of education
• Why?
• Study design
• Study treatment variability
• Concomitant treatment
• Evaluation criteria
• Preliminary points to consider for methodology

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Study design (1/5) Patient selection

• Randomization
• Boutron 45 to 49 adequate randomization
  sequence
• Patient selectionWho accepts to participate?
  Potential bias.(Who benefits most from
  education?)
• Proposal CONSORT diagram

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Example CONSORT Group education in RA
(Dougados)
1242 patients screened
102 exclusion criteria
932 refused participation
316 distance
398 schedule
218 no motive
208 patients included
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Study design (2/5) Blinding

• Difficult in non-pharmacological therapies

Boutron, JAMA 2003
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Study design (3/5) Control group intervention

• No possibility of placebo
• Hawthorne effect effect of being taken in
  charge
• Proposal control group information leaflet
  however placebo effect lt placebo effect of group
  education sessions

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Study design (4/5) Contamination

• Patients interaction in the waiting room
• Same care providers doctors, nurses,
  physiotherapists
• Contamination is difficult to measure and rarely
  reported in RCTs
• Proposal cluster randomization

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Example PREUVES trial RCT of standardized
tools and/or home-based exercises in OA. Study
design Dougados in press
Randomization of rheumatologists N 867
Standardized tools N 220
Lack of intervention N 221
Exercises N 213
Standardized tools exercises N 213
Patients N 760
Patients N 782
Patients N 735
Patients N 680
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Study design (5/5) Analysis

• Intention-to-treat or completer?
• Completer more frequent in non-pharmacological
  trials (48 versus 28) Boutron 2003
• Definition of completer, of compliance
• For sessions, a priori definition of required
  presence
• For booklets, videos?
• Lost to follow-up high rate
• in RA Lindroth, BJR 95 50 at 5 years.
• Are patients lost to follow-up different?
  Lindroth more exercise in lost to follow-up.

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• Introduction
• Education in AS literature review-methods and
  results
• Results of the ASAS survey
• Methodology of education
• Why?
• Study design
• Study treatment variability
• Concomitant treatment
• Evaluation criteria
• Preliminary points to consider for methodology

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Study treatment variability (1/5)Education
techniques and patients
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Study treatment variability (2/5)Education
techniques and patients
(puppet show) Darmawan
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Study treatment variability (3/5)Education
techniques and patients

• Individualisation of intervention specific to
  non-pharmacological trials (Boutron 30 versus
  3).
• Group interventions
• Length/frequency ASAS survey from 6 hours
  (one full day) to 2hrs per week,all year
• Group size ASAS survey 6-10 patients (12 ASAS
  answers), 10-20 patients (4 ASAS answers), 15-100
  patients (1 ASAS answer)
• Location ASAS survey rheumatology unit 10
  ASAS answers, rehabilitation unit 9, community
  setting 4, private practice 2, spa 1

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Study treatment variability (4/5)Care provider

• Who delivers education?
• Health professionals
• Lay-led, community-based interventions based on a
  manual
• Variations in care provider skill and
  personality.
• How to take into account experience and learning
  curve of care provider?
• Necessity of care provider training?

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Study treatment variability (4/5)Quality
evaluation

• How to evaluate technical quality of group
  interventions? Filming?
• How to evaluate compliance to home individual
  interventions?

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• Introduction
• Education in AS literature review-methods and
  results
• Results of the ASAS survey
• Methodology of education
• Why?
• Study design
• Study treatment variability
• Concomitant treatment
• Evaluation criteria
• Preliminary points to consider for methodology

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Concomitant treatment

• Concomitant treatment or evaluation criterion?
• If anti-TNF use is more important in the
  education group is this or -?
• Description often lacking Boutron concomitant
  treatment reported in 24 of non-pharmacological
  trials versus 58 pharmacological trials.

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• Introduction
• Education in AS literature review-methods and
  results
• Results of the ASAS survey
• Methodology of education
• Why?
• Study design
• Study treatment variability
• Concomitant treatment
• Evaluation criteria
• Preliminary points to consider for methodology

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Evaluation criteria (1/4)
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Evaluation criteria (2/4)
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Evaluation criteria (3/4)
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Evaluation criteria (4/4)
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• Introduction
• Education in AS literature review-methods and
  results
• Results of the ASAS survey
• Methodology of education
• Why?
• Study design
• Study treatment variability
• Concomitant treatment
• Evaluation criteria
• Preliminary points to consider for methodology

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Study design Points to consider
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Study treatment variability Points to consider

• Inherent variability in technique, location, size
  of groups
• Detailed description of intervention

• Concomitant treatments
• Points to consider

• Detailed description of concomitant treatments

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Evaluation criteria Points to consider

• Selection of domains and tools

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Conclusion

• Education in AS is considered as important
• Methodological issues
• Available data to answer methodological questions
  are scarce
• ASAS implication?