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Avoiding waste in research:
the role of public involvement


        Iain Chalmers
Coordinator, James Lind Initiative


‘Putting people first in research’
      INVOLVE Conference
  Nottingham, 13 November 2012
The skeletons in academic
  medicine’s cupboards
Questions relevant
                         Appropriate design          Accessible              Unbiased and
  to clinicians &
                           and methods?           full publication?          usable report?
     patients?

Low priority questions   Over 50% studies        Over 50% of studies       Over 30% of trial
addressed                designed without        never published in full   interventions not
                         reference to                                      sufficiently described
Important outcomes       systematic reviews of   Biased under-
not assessed             existing evidence       reporting of studies      Over 50% of planned
                                                 with disappointing        study outcomes not
Clinicians and           Over 50% of studies     results                   reported
patients not involved    fail to take adequate
in setting research      steps to reduce                                   Most new research
agendas                  biases, e.g.                                      not interpreted in the
                         unconcealed                                       context of systematic
                         treatment allocation                              assessment of other
                                                                           relevant evidence

                                  50                      50                        50
                                  %                       %                         %

              85% Research waste = over $85 Billion / year
Mismatch of patients’ and researchers’
priorities for osteoarthritis of the knee
              Tallon, Chard and Dieppe. Lancet, 2000.
Priority treatment outcome from a
survey of patients with rheumatoid
arthritis was not pain

It was fatigue
Involve conference 2
For every ongoing trial being conducted
within the NHS, the UK Clinical Trials
Gateway should aim to provide access to:

• a lay summary
• the patient information sheet
• the WHO 20-item dataset
• the protocol, with links to the systematic
  review(s) showing why the trial is needed
• the trial website (if one exists)
Reliable, user-friendly
 information about specific
  ongoing clinical trials is
still NOT generally available
Involve conference 2
2003-
 The James Lind Initiative
 Funded by the National Institute of Health
Research and the Medical Research Council

“to promote acknowledgement
   of uncertainties about the
   effects of treatments, and
  research to address them.”
Programme of work of
         The James Lind Initiative

1. Identifying and publishing uncertainties about the
   effects of treatments: UK Database of
   Uncertainties about the Effects of Treatments
2. Identifying patients’ and clinicians’ shared
   priorities for research about the effects of
   treatments: James Lind Alliance
3. Explaining and illustrating the development of fair
   tests of treatments in health care: James Lind
   Library and Testing Treatments
The UK Database of Uncertainties
   about the Effects of Treatments



Established to publish uncertainties about
 the effects of treatments which cannot
  currently be answered by referring to
  relevant and reliable, up-to-date
    systematic reviews of existing
           research evidence
UK DUETs draws on three main sources

 •Patients', carers' and clinicians' unanswered
  questions about the effects of treatments
 •Research recommendations in reports of
  systematic reviews and clinical guidelines
 •Ongoing research, both systematic reviews in
  preparation and new 'primary' studies
Involve conference 2
Programme of work of
         The James Lind Initiative

1. Identifying and publishing uncertainties about the
   effects of treatments: UK Database of
   Uncertainties about the Effects of Treatments
2. Identifying patients’ and clinicians’ shared
   priorities for research about the effects of
   treatments: James Lind Alliance
3. Explaining and illustrating the development of fair
   tests of treatments in health care: James Lind
   Library and Testing Treatments
To increase the focus of the therapeutic
  research agenda on questions and
  priorities shared by patients and clinicians.

To promote Priority Setting Partnerships
  involving patients and clinicians to
  identify and promote their shared
  priorities for therapeutic research.

To increase general awareness and
  understanding of the need to refocus the
  therapeutic research agenda.
Lester Firkins
                           Chair, JLA Strategy
                          & Development Group




     Sally Crowe                                  Katherine Cowan
Chair, JLA Monitoring &                          Editor, JLA Guidebook
 Implementation Group




                           Patricia Atkinson
                             Administrator,
                            JLA Secretariat
Involving patients, carers and
   clinicians in research priority setting
            The JLA’s principles
•Inclusive
   •Balance of perspectives
   •Accessible to all
•Supportive
   •Recognising a range of capacities and skills
•Transparent and democratic
   •Data sharing
   •Agreed protocol
   •Declaration of interests
   •Neutral facilitation
   •Communication and feedback
JLA Priority Setting Partnerships

Completed                 Current
•Asthma                   •Acne
•Urinary incontinence     •Childhood disability
•Vitiligo                 •Dementia
•Prostate cancer          •Dialysis
•Schizophrenia            •Head and neck cancer
•Type 1 diabetes          •Inflammatory bowel disease
•ENT aspects of balance   •Lyme disease
•Life after stroke        •Multiple sclerosis
•Eczema                   •Pressure ulcers
•Tinnitus                 •Pre-term birth
•Cleft lip and palate     •Sight loss and vision
Research priority themes [across asthma,
  incontinence, vitiligo, eczema, stroke, prostate cancer,
  schizophrenia, aspects of balance, and type 1 diabetes]

• Assessment of long-term effects (wanted and
  unwanted) of treatments
• Assessment of safety and adverse effects of
  treatments
• Assessment of complementary and non-prescribed
  treatments
• Assessment of strategies to improve early diagnosis
  and treatments, and harmonisation of practice
• Assessment of the effectiveness and safety of self-
  care
Questions relevant
                         Appropriate design          Accessible              Unbiased and
  to clinicians &
                           and methods?           full publication?          usable report?
     patients?

Low priority questions   Over 50% studies        Over 50% of studies       Over 30% of trial
addressed                designed without        never published in full   interventions not
                         reference to                                      sufficiently described
Important outcomes       systematic reviews of   Biased under-
not assessed             existing evidence       reporting of studies      Over 50% of planned
                                                 with disappointing        study outcomes not
Clinicians and           Over 50% of studies     results                   reported
patients not involved    fail to take adequate
in setting research      steps to reduce                                   Most new research
agendas                  biases, e.g.                                      not interpreted in the
                         unconcealed                                       context of systematic
                         treatment allocation                              assessment of other
                                                                           relevant evidence

                                  50                      50                        50
                                  %                       %                         %

              85% Research waste = over $85 Billion / year
Publication (2007) after registration (1999)


             Country



              Size



              Phase


              Funder




Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM (2009). Trial publication after
registration in ClinicalTrials.Gov: a cross-sectional analysis. PLoS Med 6(9): e1000144.
“Studies that report positive or significant results
are more likely to be published and outcomes
that are statistically significant have higher odds
of being fully reported.”
                 PLoS ONE, August 2008;3:e3081
Involve conference 2
Alessandro Liberati
Because research results have not
been made public…

…patients have suffered and died
unnecessarily and resources for health
care and health research have been
wasted.
TGN1412
      TGN 1412
Involve conference 2
Involve conference 2
Involve conference 2
Involve conference 2
Involve conference 2
Involve conference 2
What is the position of the
Academy of Medical Sciences?
2006 letter to Prof John Bell,
President, Academy of Medical Sciences
Involve conference 2
What should be done?
The public needs to be made
aware of how the resources they
provide for research are being
wasted.

The public needs to hold the
research community to account,
and be critically involved in
research, from agenda setting to
dissemination of results.
Programme of work of
         The James Lind Initiative

1. Identifying and publishing uncertainties about the
   effects of treatments: UK Database of
   Uncertainties about the Effects of Treatments
2. Identifying patients’ and clinicians’ shared
   priorities for research about the effects of
   treatments: James Lind Alliance
3. Explaining and illustrating the development of fair
   tests of treatments in health care: James Lind
   Library and Testing Treatments
www.jameslindlibrary.org
Involve conference 2
Promote research on the effects of treatments…




…but only if it meets scientific and ethical principles
www.testingtreatments.org
“Bad Science introduces the basic scientific principles to
help everyone become a more effective bullshit detector.”

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Involve conference 2

  • 1. Avoiding waste in research: the role of public involvement Iain Chalmers Coordinator, James Lind Initiative ‘Putting people first in research’ INVOLVE Conference Nottingham, 13 November 2012
  • 2. The skeletons in academic medicine’s cupboards
  • 3. Questions relevant Appropriate design Accessible Unbiased and to clinicians & and methods? full publication? usable report? patients? Low priority questions Over 50% studies Over 50% of studies Over 30% of trial addressed designed without never published in full interventions not reference to sufficiently described Important outcomes systematic reviews of Biased under- not assessed existing evidence reporting of studies Over 50% of planned with disappointing study outcomes not Clinicians and Over 50% of studies results reported patients not involved fail to take adequate in setting research steps to reduce Most new research agendas biases, e.g. not interpreted in the unconcealed context of systematic treatment allocation assessment of other relevant evidence 50 50 50 % % % 85% Research waste = over $85 Billion / year
  • 4. Mismatch of patients’ and researchers’ priorities for osteoarthritis of the knee Tallon, Chard and Dieppe. Lancet, 2000.
  • 5. Priority treatment outcome from a survey of patients with rheumatoid arthritis was not pain It was fatigue
  • 7. For every ongoing trial being conducted within the NHS, the UK Clinical Trials Gateway should aim to provide access to: • a lay summary • the patient information sheet • the WHO 20-item dataset • the protocol, with links to the systematic review(s) showing why the trial is needed • the trial website (if one exists)
  • 8. Reliable, user-friendly information about specific ongoing clinical trials is still NOT generally available
  • 10. 2003- The James Lind Initiative Funded by the National Institute of Health Research and the Medical Research Council “to promote acknowledgement of uncertainties about the effects of treatments, and research to address them.”
  • 11. Programme of work of The James Lind Initiative 1. Identifying and publishing uncertainties about the effects of treatments: UK Database of Uncertainties about the Effects of Treatments 2. Identifying patients’ and clinicians’ shared priorities for research about the effects of treatments: James Lind Alliance 3. Explaining and illustrating the development of fair tests of treatments in health care: James Lind Library and Testing Treatments
  • 12. The UK Database of Uncertainties about the Effects of Treatments Established to publish uncertainties about the effects of treatments which cannot currently be answered by referring to relevant and reliable, up-to-date systematic reviews of existing research evidence
  • 13. UK DUETs draws on three main sources •Patients', carers' and clinicians' unanswered questions about the effects of treatments •Research recommendations in reports of systematic reviews and clinical guidelines •Ongoing research, both systematic reviews in preparation and new 'primary' studies
  • 15. Programme of work of The James Lind Initiative 1. Identifying and publishing uncertainties about the effects of treatments: UK Database of Uncertainties about the Effects of Treatments 2. Identifying patients’ and clinicians’ shared priorities for research about the effects of treatments: James Lind Alliance 3. Explaining and illustrating the development of fair tests of treatments in health care: James Lind Library and Testing Treatments
  • 16. To increase the focus of the therapeutic research agenda on questions and priorities shared by patients and clinicians. To promote Priority Setting Partnerships involving patients and clinicians to identify and promote their shared priorities for therapeutic research. To increase general awareness and understanding of the need to refocus the therapeutic research agenda.
  • 17. Lester Firkins Chair, JLA Strategy & Development Group Sally Crowe Katherine Cowan Chair, JLA Monitoring & Editor, JLA Guidebook Implementation Group Patricia Atkinson Administrator, JLA Secretariat
  • 18. Involving patients, carers and clinicians in research priority setting The JLA’s principles •Inclusive •Balance of perspectives •Accessible to all •Supportive •Recognising a range of capacities and skills •Transparent and democratic •Data sharing •Agreed protocol •Declaration of interests •Neutral facilitation •Communication and feedback
  • 19. JLA Priority Setting Partnerships Completed Current •Asthma •Acne •Urinary incontinence •Childhood disability •Vitiligo •Dementia •Prostate cancer •Dialysis •Schizophrenia •Head and neck cancer •Type 1 diabetes •Inflammatory bowel disease •ENT aspects of balance •Lyme disease •Life after stroke •Multiple sclerosis •Eczema •Pressure ulcers •Tinnitus •Pre-term birth •Cleft lip and palate •Sight loss and vision
  • 20. Research priority themes [across asthma, incontinence, vitiligo, eczema, stroke, prostate cancer, schizophrenia, aspects of balance, and type 1 diabetes] • Assessment of long-term effects (wanted and unwanted) of treatments • Assessment of safety and adverse effects of treatments • Assessment of complementary and non-prescribed treatments • Assessment of strategies to improve early diagnosis and treatments, and harmonisation of practice • Assessment of the effectiveness and safety of self- care
  • 21. Questions relevant Appropriate design Accessible Unbiased and to clinicians & and methods? full publication? usable report? patients? Low priority questions Over 50% studies Over 50% of studies Over 30% of trial addressed designed without never published in full interventions not reference to sufficiently described Important outcomes systematic reviews of Biased under- not assessed existing evidence reporting of studies Over 50% of planned with disappointing study outcomes not Clinicians and Over 50% of studies results reported patients not involved fail to take adequate in setting research steps to reduce Most new research agendas biases, e.g. not interpreted in the unconcealed context of systematic treatment allocation assessment of other relevant evidence 50 50 50 % % % 85% Research waste = over $85 Billion / year
  • 22. Publication (2007) after registration (1999) Country Size Phase Funder Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM (2009). Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis. PLoS Med 6(9): e1000144.
  • 23. “Studies that report positive or significant results are more likely to be published and outcomes that are statistically significant have higher odds of being fully reported.” PLoS ONE, August 2008;3:e3081
  • 26. Because research results have not been made public… …patients have suffered and died unnecessarily and resources for health care and health research have been wasted.
  • 27. TGN1412 TGN 1412
  • 34. What is the position of the Academy of Medical Sciences?
  • 35. 2006 letter to Prof John Bell, President, Academy of Medical Sciences
  • 37. What should be done? The public needs to be made aware of how the resources they provide for research are being wasted. The public needs to hold the research community to account, and be critically involved in research, from agenda setting to dissemination of results.
  • 38. Programme of work of The James Lind Initiative 1. Identifying and publishing uncertainties about the effects of treatments: UK Database of Uncertainties about the Effects of Treatments 2. Identifying patients’ and clinicians’ shared priorities for research about the effects of treatments: James Lind Alliance 3. Explaining and illustrating the development of fair tests of treatments in health care: James Lind Library and Testing Treatments
  • 41. Promote research on the effects of treatments… …but only if it meets scientific and ethical principles
  • 43. “Bad Science introduces the basic scientific principles to help everyone become a more effective bullshit detector.”