final phase ii scientific reviewer training

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PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE October 2012 Pa#entCentered Outcomes Research Ins#tute (PCORI) Phase II Scien4fic Reviewer Training

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Page 1: Final phase ii scientific reviewer training

PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE

October  2012  

Pa#ent-­‐Centered  Outcomes  Research  Ins#tute  (PCORI)  Phase  II  Scien4fic  Reviewer  Training  

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Housekeeping  –  Presenta4on  Mode  

Ø  A9endee  phone  lines  are  muted    Ø  Ques#ons  may  be  submi9ed  via  Chat  in  

the  lower  right  hand  side  of  your  screen  à    

 Ø  Please  send  ques#ons  as  they  occur  to  

you.  They  will  be  answered  at  the  end  of  the  session,  as  #me  permits  

Ø  Press  “0”  on  the  phone  for  a  private  help  session  with  the  operator  

1. Type your question here.

 

2. Click Send

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Agenda              

1.   Introduc4on  and  Announcements  

2.      Background  

5. Merit  Review:  Phase  I  –  Scien#fic  Review  

6.      Merit  Review:  Phase  II  –  Impact  Review  

7.      Merit  Review:  Phase  II  –  In-­‐Person  Panel  

3.      Program  Funding  Announcements    

4. The  Applica#on  and  Review  Process  

8.      Phase  II:  PCORI  Online  –  Process  and  Procedures  

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Our  SROs  

Parag  Aggarwal,  Ph.D.  

Howard  Underwood,  MD,  MBA,  MS   Jessica  Nadler,  Ph.D.  

Assessment  of  Preven4on,  Diagnosis,  and  Treatment  Op4ons    

Lev  Nevo,  MD   Sabina  I.  Robinson,  Ph.D.  

Improving  Healthcare  Systems  

Kimberly  A.  Marschhauser,  Ph.D.  

Marianne  H.  Alcia#,  Ph.D.  

Communica4on  and  Dissemina4on  Research  

Addressing  Dispari4es  

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Announcements  

Open  session  to  any  per4nent  announcements    

Phase  II  Assignments  Released  –  Oct  12th    Preliminary  Scores  Due  –  November  2nd  at  5:00  pm    Op#onal  Dinner  –  Nov  14th  in  Washington,  DC  from  6:00  pm  –  9:30  pm    Phase  II  Panels  –  Nov  15th  in  Washington,  DC  from  7:00  am  –  3:00  pm  

Key  Dates  

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Agenda              

1.  Introduc#on  and  Announcements  

2.      Background  

5. Merit  Review:  Phase  I  –  Scien#fic  Review  

6.      Merit  Review:  Phase  II  –  Impact  Review  

7.      Merit  Review:  Phase  II  –  In-­‐Person  Panel  

3.      Program  Funding  Announcements    

4. The  Applica#on  and  Review  Process  

8.      Phase  II:  PCORI  Online  –  Process  and  Procedures  

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PCORI  Mission,  Vision  and  PCOR  

PCORI  Mission  Statement  

PCORI  helps  people  make  informed  healthcare  decisions  and  improves  healthcare  delivery  and  

outcomes  by  producing  and  promo#ng  high  integrity,  evidence-­‐based  informa#on  that  comes  from  

research  guided  by  pa#ents,  caregivers,  and  the  broader  health  care  community.  

 

Ø  PCORI  is  a  non-­‐governmental,  non-­‐profit  organiza#on  founded  by  the  Pa#ent  Protec#on  and  Affordable  Healthcare  Act  of  2010    (h9p://www.pcori.org/assets/PCORI_EstablishingLeg.pdf)  

 Ø  PCORI  aims  to  fund  pa#ent-­‐centered  

research  that  will  improve  healthcare  outcomes  for  pa#ents,  their  caregivers,  and  other  stakeholders  

 Ø  Pa4ent-­‐centered  outcomes  research  

(PCOR)  helps  people  and  their  caregivers  communicate  and  make  informed  healthcare  decisions,  allowing  their  voices  to  be  heard  in  assessing  the  value  of  healthcare  op#ons  

For  more  informa#on  on  PCOR,  please  reference  the  PCORI  Methodology  report  at:  h9p://pcori.org/assets/MethodologyReport-­‐Comment.pdf    

Vision  

Pa#ents  and  the  public  have  the  informa#on  they  need  to  make  decisions  that  reflect  their  desired  

health  outcomes.  

 

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Provide  informa#on  to  PCORI  that  informs  future  itera#ons  of  na#onal  research  priori#es  for  pa#ent-­‐centered  outcomes  research.    

The  Na#onal  Priori#es  are:  

1.  Compara#ve  Assessments  of  Preven#on,  Diagnosis,  and  Treatment  Op#ons  

2.  Improving  Healthcare  Systems  

3.  Communica#on  and  Dissemina#on  

4.  Addressing  Dispari#es  5.  Accelera#ng  Pa#ent-­‐

Centered  and  Methodological  Research  

Purpose  

Support  the  collec#on  of  preliminary  data  to  advance  the  field  of  pa#ent-­‐centered  outcomes  research,  providing  the  plagorm  for  an  evolving  PCORI  research  agenda.  PCORI’s  ini#al  Research  Agenda:  

1.  Comparisons  of  Preven#on,  Diagnosis,  and  Treatment  Op#ons  

2.  Improving  Healthcare  Systems  3.  Communica#on  &  Dissemina#on  4.  Addressing  Dispari#es  5.  Accelera#ng  Pa#ent-­‐Centered  and  

Methodological  Research  

Research  Agenda  

Support  iden#fica#on  of  research  methodologies  that  advance  pa#ent-­‐centered  outcomes  research  

Methodologies  

PCORI’s  Na4onal  Priori4es  

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   Why  PCORI  is  Unique  

PCORI  is  unique  because:  (a)  it  requires  stakeholders  included  as  part  of  the  research  team,  and  (b)  research  must  be  focused  on  pa4ent-­‐centered  outcomes    

•  Projects  must  include  stakeholders  as  partners  with  significant  involvement  at  all  appropriate  stages  of  the  research  project  

•  Tangible,  meaningful  outcomes  are  the  ul#mate  goal  of  all  funded  research  

Who  are  Stakeholders?  

•  Pa#ents  and  caregivers  

•  Pa#ent  and  caregiver  organiza#ons  

•  Clinician  and  clinician  organiza#ons  

•  Organiza#onal  Providers  

•  Purchasers  

 

•  Payers  

•  Industry  

•  Researchers  

•  Policymakers  

•  Training  ins#tu#ons  

•  Others  who  can  bring  insight  

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Stakeholder  Engagement  

PCORI  is  seizing  the  opportunity  to  engage  stakeholders  in  unprecedented  ways:  

To  create  more  relevant  decision-­‐making  tools  to  assure  

be9er  pa#ent  outcomes  

Why Engage Stakeholders?

•  Partners  in  the  research  project  enterprise  

•  Inclusion  as  equal  partners  in  research  review  

•  Leverage  their  value,  including  wisdom  and  unique  exper#se  

•  Increase  the  relevance  and  impact  of  research  by  integra#ng  mul#ple  stakeholders  into  the  process  

 •  Foster  environments  that  facilitate  cross-­‐fer#liza#on  and  novel  collabora#ons  

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Agenda              

1.  Introduc#on  and  Announcements  

2.      Background  

5. Merit  Review:  Phase  I  –  Scien#fic  Review  

6.      Merit  Review:  Phase  II  –  Impact  Review  

7.      Merit  Review:  Phase  II  –  In-­‐Person  Panel  

3.      Program  Funding  Announcements    

4. The  Applica#on  and  Review  Process  

8.      Phase  II:  PCORI  Online  –  Process  and  Procedures  

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PCORI  Funding  Announcements  

The  current  funding  cycle  has  four  issued  PFAs:  

PCORI  Funding  Announcements  (PFAs)  are  the  mechanisms  

Accelera'ng  Pa'ent-­‐Centered  Outcomes  

Research  and  Methodological  

Research  

And  coming  this  fall  2012:  

by  which  PCORI  gives  out  research  funding  

Assessment  of  Preven4on,  Diagnosis,  and  Treatment  Op4ons    

Improving  Healthcare  Systems    

Communica4on  and  Dissemina4on  Research    

Addressing  Dispari4es    

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PFAs  

Assessment  of  Preven4on,  Diagnosis,  and  Treatment  Op4ons  

Projects  that  address  cri4cal  decisions  that  pa4ents,  their  caregivers,  and  clinicians  face  with  too  lible  informa4on  

In  this  PFA  we  seek  to  fund  projects  that:    •  Address  cri'cal  decisions  that  face  pa'ents,  their  

caregivers,  and  clinicians  every  day  and  with  too  li?le  informa'on  

•  Address  consequen'al  decisions  now  occurring  without  key  evidence  about  the  compara've  effec'veness  of  two  or  more  op'ons  

•  Benefit  pa'ents/caregivers  with  new  knowledge  in  ways  that  are  clear  and  important  

 

Available  funds:    $48  Million  

Expected  awards:    54  awards  

Maximum  project  period:  3  years  

Ini#al  funding  period:  December  2012  –  January  2013  

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PFAs  

Improving  Healthcare  Systems  

Projects  that  address  cri4cal  decisions  that  face  healthcare  systems,  the  pa4ents  and  caregivers  who  rely  on  them,  and  the  clinicians  who  work  within  them  

In  this  PFA  we  seek  to  fund  projects  that:    •  Address  cri'cal  decisions  that  face  healthcare  

system  leaders  and  policymakers,  clinicians,  and  the  pa'ents  and  caregivers  who  rely  on  them  

•  Offer  substan'al  poten'al  that  pa'ents/caregivers  will  benefit  from  the  new  knowledge  in  ways  that  are  important  

 

Available  funds:    $24  Million  

Expected  awards:    27  awards  

Maximum  project  period:  3  years  

Ini#al  funding  period:  December  2012  –  January  2013  

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PFAs  

Communica4on  and  Dissemina4on  Research  

Projects  that  address  cri4cal  elements  in  the  communica4on  and  dissemina4on  process  among  pa4ents,  their  caregivers  and  clinicians  

In  this  PFA  we  seek  to  fund  projects  that:    •  Address  cri'cal  knowledge  gaps  in  the  

communica'on  and  dissemina'on  process  

•  Gaps  to  consider:    Ø  The  communica'on  and  dissemina'on  of  

research  results  to  pa'ents,  their  caregivers,  and  clinicians    

Ø  The  communica'on  between  pa'ents,  caregivers,  and  clinicians  in  the  service  of  enabling  pa'ents  and  caregivers  to  make  the  best  possible  decisions  in  choosing  among  available  op'ons  for  care  and  treatment  

Available  funds:    $12  Million  

Expected  awards:    14  awards  

Maximum  project  period:  3  years  

Ini#al  funding  period:  December  2012  –  January  2013  

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PFAs  

Addressing  Dispari4es  

Projects  that  will  inform  the  choice  of  strategies  to  eliminate  dispari4es  

In  this  PFA  we  seek  to  fund  projects  that:    •  Will  inform  the  choice  of  strategies  to  eliminate  

dispari'es  Ø  We  are  not  interested  in  studies  that  

describe  dispari'es;  instead,  we  want  studies  that  will  iden'fy  best  op'ons  for  elimina'ng  dispari'es  

•  Focus  on  areas  of  importance  to  pa'ents  and  their  caregivers,  where  there  are  cri'cal  dispari'es  that  disadvantage  members  of  a  par'cular  group  and  limit  their  ability  to  achieve  op'mal,  pa'ent-­‐centered  outcomes  

Available  funds:    $12  Million  

Expected  awards:    14  awards  

Maximum  project  period:  3  years  

Ini#al  funding  period:  December  2012  –  January  2013  

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Agenda              

1.  Introduc#on  and  Announcements  

2.      Background  

5. Merit  Review:  Phase  I  –  Scien#fic  Review  

6.      Merit  Review:  Phase  II  –  Impact  Review  

7.      Merit  Review:  Phase  II  –  In-­‐Person  Panel  

3.      Program  Funding  Announcements    

4. The  Applica4on  and  Review  Process  

8.      Phase  II:  PCORI  Online  –  Process  and  Procedures  

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Applica4on  and  Review  Process  Summary  

Applica4on  Merit  Review   Approval  

•  LOI  submission  via  PCORI  Online  

•  Applica#on  submission  via  PCORI  Online  

•  Internal  quality  control  

•  Phase  I:  Scien#fic/  Technical  Review  

•  Phase  II:  In-­‐person  panel  –  Impact  Review  

•  PCORI  Business  Review  and  Balance  Analysis  

•  Board  of  Governors  Approval  

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The  Merit  Review  Process  

The  process  by  which  applica4ons  for  research  funding  are  evaluated  –    

Phase  I  •  Each  applica#on  is  assigned  to  a  pre-­‐

determined,  set  number  of  reviewers  

•  Phase  I  Reviewers  have  scien#fic  exper#se,  and  assess  the  applica#on  for  scien#fic  rigor  and  research  approach  

•  Reviewers  assign  an  ini#al  priority  score  of  1  to  9  based  on  all  eight  PCORI  merit  review  criteria  

•  Scores  are  compiled    •  Top  scoring  applica#ons  proceed  to  

Phase  II  

 

Phase  II  •  Scien#st  and  Pa#ents/Stakeholders  

assess  Phase  I  cri#que  and  assign  one  (1)  preliminary  score  and  cri#que  

•  Panel  of  chairs  plus  two  scien#fic,  one  stakeholder,  and  one  pa#ent  reviewer  convene  in-­‐person  for  discussion  and  re-­‐score  

 

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   Merit  Review  Phase  II:  Overview  

As  a  Phase  II  Reviewer,  you  are  responsible  for  assessing  and  appropriately  scoring  your  assigned  applica4ons  

Access  Assigned  Cri4ques  &  Scores  

Assign  Preliminary  Score  

&  Cri4que  

Key Tasks

Raise  issues,  risks,  and  request  support  as  needed  

1.  Access  Phase  II  scores  and  cri#ques  in  PCORI  Online  2.  Conflict  of  Interest  (COI):  Ensure  no  conflict  exits  3.  Assign  preliminary  numerical  preliminary  impact  score  (1-­‐9)  and  provide  cri#que  4.  Panels  convene  and  discuss  5.  Assign  final  impact  scores  

In-­‐Person  Review  Panels  

Final  Impact  Scoring  

COI  

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 Conflicts  of  Interest  

What  is  a  conflict  of  interest?   As  defined  by  PCORI’s  establishing  legisla#on,  a  conflict  of  interest  is  any  “associa#on,  including  a  financial  or  personal  associa#on;  that  has  the  poten#al  to  bias  or  have  the  appearance  of  biasing  an  individual’s  decisions  in  ma9ers  related  to  the  Ins#tute  or  the  conduct  of  ac#vi#es”.        Conflicts  of  interest  will  be  considered  and  prohibited  throughout  every  step  of  the  review  and  selec#on  process,  including  but  not  limited  to:  the  technical  and  programma#c  reviews,  the  selec#on  and  assignment  of  scien#fic  and  stakeholder  reviewers,  Board  of  Governors  delibera#ons,  and  post-­‐award  nego#a#ons  and  monitoring.  

More  informa4on  is  included  in  the  PCORI  Online  confiden4ality  and  conflict  of  interest  document  that  you  must  agree  to  in  order  to  access  your  applica4ons.  

 

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   Your  Role  

Some  addi4onal  guidance  about  your  role  and  ac4vi4es  as  a  Phase  II  Scien4fic  Reviewer:  

Before  the  in-­‐person  review  panels  on  November  15th:  •  Access  your  assigned  applica#ons  in  PCORI  Online  •  Score  and  provide  wri9en  comments  •  Be  prepared  to  substan#vely  qualify  and  discuss  your  score  and  comments  during  

the  in-­‐person  review  panel    

During  the  in-­‐person  review  panel:  •  Reviewers  assigned  to  each  applica#on  will  briefly  discuss  their  preliminary  score  

and  provide  feedback  •  Open  to  panel-­‐wide  discussion  •  All  reviewers  assign  a  final  score  in  real-­‐#me,  on  personal  laptops  via  PCORI  

Online  •  Scores  are  compiled  and  averaged  by  PCORI  

•  Top  scoring  applica#ons  will  be  forwarded  and  receive  recommenda#on  for  funding  

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Agenda              

1.  Introduc#on  and  Announcements  

2.      Background  

5. Merit  Review:  Phase  I  –  Scien4fic  Review  

6.      Merit  Review:  Phase  II  –  Impact  Review  

7.      Merit  Review:  Phase  II  –  In-­‐Person  Panel  

3.      Program  Funding  Announcements    

4. The  Applica#on  and  Review  Process  

8.      Phase  II:  PCORI  Online  –  Process  and  Procedures  

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Merit  Review  Criteria  

•  Impact  of  the  Condi4on  

•  Innova#on/    Poten#al  for  Improvement  

•  Impact  on  Healthcare  Performance  

•  Pa#ent-­‐Centeredness  

•  Rigorous  Research  Methods  

•  Inclusiveness  of  Different  Popula#ons  

•  Team  and  Environment  

•  Efficient  Use  of  Resources  

Criterion  1:  Impact  of  the  Condi?on    on  the  Health  of  Individuals  and  Popula?ons  

§  Does  the  applica#on  specify  the  burden  of  the  disease  or  area  under  considera#on,  with  a  preference  for  the  U.S.  popula#on,  including:  

Ø The  frequency  of  the  disease/condi#on,    Ø Expected  mortality  and  burden  of  suffering  from  symptoms,      

Ø Complica#ons  or  other  consequences  of  the  disease/condi#on,      Ø The  frequency  with  which  the  interven#on  or  treatment  would  

apply,  Ø Costs  to  the  US  popula#on  (healthcare  services  u#liza#on),  and  

to  individual  pa#ents  (out-­‐of-­‐pocket  and  intangible  costs).  

§  Primary  emphasis  is  on  chronic  condi#ons,  as  well  as  preven#on  and  treatment  of  common  acute  events  that  may  have  long-­‐term  consequences.  

§  Studies  that  are  relevant  to  pa#ents  with  two  or  more  condi#ons  are  also  of  interest.  Also  of  interest  are  rare  diseases.    

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Criterion  2:  Innova?on  and  Poten?al  for  Improvement  Through  Research  

§  How  will  the  research  influence  current  prac#ce  and  lead  to  meaningful  improvement  in  pa#ent  health,  well-­‐being,  or  quality  of  care?  

§  Does  the  research  involve  a  novel  interven#on  or  employ  an  innova#ve  approach  in  terms  of  analy#cs,  study  popula#on,  or  research  team  that  makes  it  more  likely  to  change  prac#ce?    

§  Does  preliminary  data  suggest  that  the  comparison  will  show  large  differences  in  effec#veness?  

§  Does  the  research  ques#on  address  a  cri#cal  gap  in  current  knowledge?  Has  it  been  iden#fied  as  important  by  pa#ent,  caregiver,  or  clinician  groups?  Have  other  agencies  iden#fied  this  topic  as  a  priority?  

§  How  quickly  could  posi#ve  findings  be  disseminated  to  affect  changes  in  current  prac#ce?  How  will  the  research  findings  support  improved  decision-­‐making  for  pa#ents?  

•  Impact  of  the  Condi#on  

•  Innova4on/    Poten4al  for  Improvement  

•  Impact  on  Healthcare  Performance  

•  Pa#ent-­‐Centeredness  

•  Rigorous  Research  Methods  

•  Inclusiveness  of  Different  Popula#ons  

•  Team  and  Environment  

•  Efficient  Use  of  Resources  

Merit  Review  Criteria  

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Criterion  3:  Impact  on  Healthcare  Performance  

§  What  is  the  impact  of  the  proposed  research  on  the  efficiency  of  pa#ent  care,  for  individual  pa#ents  or  for  pa#ent  popula#ons?  

§  For  example,  do  the  findings  lead  to  be9er  outcomes  for  a  given  investment  of  #me,  personnel,  or  other  resources?  Or  does  the  research  promise  poten#al  improvements  in  convenience  or  elimina#on  of  wasted  resources,  while  maintaining  or  improving  pa#ent  outcomes?  

•  Impact  of  the  Condi#on  

•  Innova#on/    Poten#al  for  Improvement  

•  Impact  on  Healthcare  Performance  

•  Pa#ent-­‐Centeredness  

•  Rigorous  Research  Methods  

•  Inclusiveness  of  Different  Popula#ons  

•  Team  and  Environment  

•  Efficient  Use  of  Resources  

Merit  Review  Criteria  

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Criterion  4:  Pa?ent-­‐Centeredness  

§  Is  the  proposed  research  focused  on  ques#ons  and  outcomes  of  specific  interest  to  pa#ents  and  their  caregivers?  Pa4ent-­‐centeredness  is  a  perspec4ve  on  health  that  is  derived  from  and  directly  relevant  to  the  pa4ent’s  experience  of  illness  and  of  care.    

§  Does  the  research  address  one  or  more  of  the  key  ques#ons  men#oned  in  PCORI’s  defini#on  of  pa#ent-­‐centered  outcomes  research?    

§  Are  the  outcomes  proposed  of  importance  to  pa#ents?  Is  the  absence  of  any  par#cularly  important  outcomes  discussed?  

§  Pa#ent  engagement  in  the  research  team  is  dis#nct  and  discussed  in  Criterion  7,  Team  and  Environment.    

•  Impact  of  the  Condi#on  

•  Innova#on/    Poten#al  for  Improvement  

•  Impact  on  Healthcare  Performance  

•  Pa4ent-­‐Centeredness  

•  Rigorous  Research  Methods  

•  Inclusiveness  of  Different  Popula#ons  

•  Team  and  Environment  

•  Efficient  Use  of  Resources  

Merit  Review  Criteria  

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Criterion  5:  Rigorous  Research  Methods  

§  Does  the  research  use  appropriate  and  rigorous  research  methods  to  generate  pa#ent-­‐centered  evidence?  

Ø Applicants  are  encouraged  to  refer  to  the  contents  of  the  first  dras  of  the  PCORI  Methodology  Report,  at  h9p://www.pcori.org/what-­‐we-­‐do/methodology,  in  developing  their  research  plan.  Because  the  dras  report  will  not  have  been  finalized  with  the  benefit  of  public  comment  before  the  July  31st,  2012  applica#on  deadline,  adherence  to  the  Report’s  standards  will  not  be  a  required  element  of  applica#ons  for  this  funding  cycle.    

Ø How  likely  is  it  that  the  proposed  study  popula#on,  study  design,  and  available  sample  size  will  yield  generalizable  informa#on  with  sufficient  precision  to  be  useful  and  reliable  for  pa#ents,  their  caregivers,  and  clinicians?  

   

•  Impact  of  the  Condi#on  

•  Innova#on/    Poten#al  for  Improvement  

•  Impact  on  Healthcare  Performance  

•  Pa#ent-­‐Centeredness  

•  Rigorous  Research  Methods  

•  Inclusiveness  of  Different  Popula#ons  

•  Team  and  Environment  

•  Efficient  Use  of  Resources  

Merit  Review  Criteria  

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Criterion  6:  Inclusiveness  of  Different  Popula?ons  

§  Does  the  research  include  diverse  popula#ons  with  respect  to  age,  gender,  race,  ethnicity,  geography,  or  previously  understudied  popula#ons  for  whom  effec#veness  informa#on  is  par#cularly  needed?  Is  the  study  popula#on  representa#ve  of  the  full  popula#on  of  interest?  

§  How  does  the  proposed  research  enable  a  more  personalized  approach  to  decision-­‐making  based  on  a  pa#ent’s  unique  biological,  clinical,  or  socio-­‐demographic  characteris#cs?  

§  Does  the  study  provide  sample  size  calcula#ons  that  will  describe  the  power  available  to  evaluate  possible  differences  in  effec#veness  in  different  groups,  or  the  precision  available  for  es#ma#ng  effec#veness  in  a  specific  previously  understudied  popula#on?  

•  Impact  of  the  Condi#on  

•  Innova#on/    Poten#al  for  Improvement  

•  Impact  on  Healthcare  Performance  

•  Pa#ent-­‐Centeredness  

•  Rigorous  Research  Methods  

•  Inclusiveness  of  Different  Popula4ons  

•  Team  and  Environment  

•  Efficient  Use  of  Resources  

Merit  Review  Criteria  

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 Criterion  7:  Team  and  Environment  

§  Are  the  inves#gators  appropriately  trained  and  experienced  to  carry  out  the  planned  studies?  Is  the  work  proposed  appropriate  to  the  experience  level  of  the  principal  inves#gator?    

§  Does  the  study  team  have  complementary  and  integrated  exper#se;  is  their  leadership  approach,  governance,  and  organiza#onal  structure  appropriate  for  the  project?    

§  Are  relevant  pa#ents  and  other  key  stakeholders  of  the  study  informa#on  appropriately  included  on  the  team?    

§  Do  the  experiments  proposed  take  advantage  of  unique  features  of  the  scien#fic  environment  or  employ  useful  collabora#ve  arrangements?    

§  Is  there  evidence  of  ins#tu#onal  or  other  support?      

•  Impact  of  the  Condi#on  

•  Innova#on/    Poten#al  for  Improvement  

•  Impact  on  Healthcare  Performance  

•  Pa#ent-­‐Centeredness  

•  Rigorous  Research  Methods  

•  Inclusiveness  of  Different  Popula#ons  

•  Team  and  Environment  

•  Efficient  Use  of  Resources  

Merit  Review  Criteria  

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 Criterion  8:  Efficient  Use  of  Research  Resources  

§  Does  the  budget  appear  to  be  reasonable  in  rela#on  to  the  poten#al  contribu#on  of  the  research?    

§  Does  the  jus#fica#on  address  the  efficiency  with  which  PCORI  resources  would  be  used?  Are  there  opportuni#es  to  make  the  study  more  efficient?  

§  Are  there  addi#onal  benefits  to  a  PCORI  investment  in  this  study  through  the  crea#on  of  common  data  or  infrastructure  that  could  support  future  research?  

•  Impact  of  the  Condi#on  

•  Innova#on/    Poten#al  for  Improvement  

•  Impact  on  Healthcare  Performance  

•  Pa#ent-­‐Centeredness  

•  Rigorous  Research  Methods  

•  Inclusiveness  of  Different  Popula#ons  

•  Team  and  Environment  

•  Efficient  Use  of  Resources  

Merit  Review  Criteria  

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Agenda              

1.  Introduc#on  and  Announcements  

2.      Background  

5. Merit  Review:  Phase  I  –  Scien#fic  Review  

6.      Merit  Review:  Phase  II  –  Impact  Review  

7.      Merit  Review:  Phase  II  –  In-­‐Person  Panel  

3.      Program  Funding  Announcements    

4. The  Applica#on  and  Review  Process  

8.      Phase  II:  PCORI  Online  –  Process  and  Procedures  

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   The  Focus  on  Impact  

PCORI  Defini4on  

Reviewers  will  provide  an  overall  impact  score  that  considers  the  following:    •  Does  the  project  have  poten4al  to  

change  clinical  prac4ce  or  pa4ent  behavior  in  ways  that  will  create  and  sustain  improvement  in  outcomes  and  the  health  of  pa4ents?  

•  How  quickly  can  the  results  of  the  project  be  disseminated  and  applied  (from  the  assessment  of  dissemina4on  and  implementa4on  poten4al)?  

The  assessment  of  impact  is  par4cularly  informed  by  three  of  the  eight  PCORI  Merit  Review  Criteria.      Use  criteria  2,  4,  and  7  to  evaluate  an  applica4on’s  answer  to  these  ques4ons  

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   The  8  Merit  Review  Criteria:  Phase  II  Focus  

Phase  II  is  centered  around  impact,  focusing    on  the  following  of  the  Merit  Review  Criteria:  

The  8  Merit  Review  Criteria:  

1.  Impact  of  the  Condi#on  

2.   Innova4on/Poten4al  for  Improvement  

3.  Impact  on  Healthcare  Performance  

4.   Pa4ent-­‐Centeredness  

5.  Rigorous  Research  Methods  

6.  Inclusiveness  of  Different  Popula#ons  

7.   Team  and  Environment  

8.  Efficient  Use  of  Resources  

 •  Innova#on  –  in  

ways  that  are  likely  to  change  prac#ce?  

•  Poten#al  for  improvement  (will  findings  improve  pa#ent  well-­‐being  or  quality  of  care?)  

Innova4on/  Poten4al  for  Improvement  

Pa4ent  Centeredness  

Team  and  Environment  

 •  Inves#gators  

trained  •  Study  team  

exper#se  •  Plan  for  leadership  

and  governance  •  Robust  pa#ent  

and  stakeholder  engagement  plan  

•  Inclusiveness  of  different  popula#ons  

•  Ins#tu#onal  or  other  relevant  organiza#onal  support  

 •  Focus  on  

ques#ons  and  outcomes  of  specific  interest  to  pa#ents  and  their  caregivers  

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   Phase  II  Key  Focus  Areas  

Criterion  2:  Innova?on  and  Poten?al  for  Improvement  Through  Research    

•  “Is  there  uncertainty?”  –  Varia#on  in  prac#ce,  systema#c  reviews  have  iden#fied  as  such,  or  pa#ent/clinician  groups  have  

specifically  called  for  this  informa#on  

•  How  will  the  research  influence  current  prac#ce  and  lead  to  meaningful  improvement  in  pa#ent  health,  well-­‐being,  or  quality  of  care?    

•  Does  the  research  involve  a  novel  interven#on  or  employ  an  innova#ve  approach  in  terms  of  analy#cs,  study  popula#on,  or  research  team  that  makes  it  more  likely  to  change  prac#ce?      

•  Does  preliminary  data  suggest  that  the  comparison  will  show  large  differences  in  effec#veness?    

•  Does  the  research  ques#on  address  a  cri#cal  gap  in  current  knowledge?  Has  it  been  iden#fied  as  important  by  pa#ent,  caregiver,  or  clinician  groups?  Have  other  agencies  iden#fied  this  topic  as  a  priority?    

•  How  quickly  could  posi#ve  findings  be  disseminated  to  affect  changes  in  current  prac#ce?  How  will  the  research  findings  support  improved  decision-­‐making  for  pa#ents?    

–  PCORI  is  interested  in  funding  studies  with  a  high  likelihood  that  results  will  be  disseminated  and  incorporated  into  prac#ce  immediately  or  within  a  short  period  of  #me  (3-­‐  5  years).    Please  refer  to  the  dissemina#on  and  implementa#on  assessment  in  the  applica#on  for  detail  and  clarifica#on,  if  necessary.  

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   Phase  II  Key  Focus  Areas  

Criterion  4:  Pa?ent  Centeredness  

•  Is  the  proposed  research  focused  on  ques#ons  and  comparisons  that  have  relevance  and  specific  interest  to  pa#ents  and  their  caregivers?  Pa4ent-­‐centeredness  is  a  perspec4ve  on  health  that  is  derived  from  and  directly  relevant  to  the  pa4ent’s  experience  of  illness  and  of  care.  

•  Does  the  research  fit  with  one  or  more  of  the  key  ques#ons  men#oned  in  PCORI’s  defini#on  of  pa#ent-­‐centered  outcomes  research?  

•  Are  the  outcomes  proposed  of  importance  to  pa#ents?  Is  the  absence  of  any  par#cularly  important  outcomes  discussed?  

•  Note:  Pa#ent  engagement  in  the  research  team  is  dis#nct  and  discussed  in  Criterion  7,  Team  and  Environment.  

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   Phase  II  Key  Focus  Areas  

 Criterion  7:  Team  and  Environment  

•  Are  the  inves#gators  appropriately  trained  and  experienced  to  carry  out  the  planned  studies?  Is  the  work  proposed  appropriate  to  the  experience  level  of  the  principal  inves#gator?    

 •  Does  the  study  team  have  complementary  and  integrated  exper#se;  is  their  leadership  

approach,  governance,  and  organiza#onal  structure  appropriate  for  the  project?      •  Are  relevant  pa#ents  and  other  key  stakeholders  in  the  study  informa#on  appropriately  

included  on  the  team?      •  Do  the  proposed  experiments  take  advantage  of  unique  features  of  the  scien#fic  environment,  

or  employ  useful  collabora#ve  arrangements?      •  Is  there  evidence  of  ins#tu#onal  support?  

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   Phase  II  Preliminary  Scoring  

Assignments  Released  

•  Assignments  are  released  in  October  

•  In  PCORI  Online  

•  Login  to  access  your  applica#ons  –  Ensure  no  conflicts  of  interest,  

and  your  qualifica#on  to  review  

•  All  applica#ons  re-­‐released  and  assigned  to  Phase  II  Reviewers  were  top  scorers  in  Phase  I  –  Have  been  ve9ed  for  basic,  hard  

science  and  programma#c  review  

Preliminary  Scoring  

•  Use  Phase  I  cri#ques  to  assign  preliminary  score  of  1-­‐9    –  You  will  have  access  to  the  full  

applica#on,  but  please  use  only  to  reference  

 •  Provide  substan#ve,  produc#ve  

comments  as  well  as  specific  strengths  and  weaknesses  to  ul#mately  help  answer  the  ques#on:  –  “How,  and  to  what  extent,  will  the  

proposed  research  plan  impact  pa'ents  in  the  next  3  to  5  years?”  

•  Enter  comments  and  numerical  score  in  PCORI  Online  

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   Reviewer  Guidance  &  Scoring  Chart  

For  the  preliminary  Phase  II  impact  score,  the  far  right  column  in  the  scoring  chart  below  provides  a  descrip4ve  guide  of  how  strengths  and  weaknesses  are  considered  in  a  ra4ng:    

 Impact Score Descriptor

1 Exceptional

2 Outstanding

3 Excellent

4 Very  Good

5 Good

6 Satisfactory

7 Fair

8 Marginal

9 Poor

High

Medium

Low

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Agenda              

1.  Introduc#on  and  Announcements  

2.      Background  

5. Merit  Review:  Phase  I  –  Scien#fic  Review  

6.      Merit  Review:  Phase  II  –  Impact  Review  

7.      Merit  Review:  Phase  II  –  In-­‐Person  Panel  

3.      Program  Funding  Announcements    

4. The  Applica#on  and  Review  Process  

8.      Phase  II:  PCORI  Online  –  Process  and  Procedures  

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   General  Logis4cs  for  Phase  II  Panel  Reviewers  

Date/Loca4on   Details  

Date  of  Phase  II  Panels:   Thursday,  November  15,  2012  

Loca4on:   Hya9  Regency  Washington  on  Capitol  Hill,  Washington  D.C.  

Time:     8:00am  to  3:00pm  

Number  of  Panels:     Five    

Ø  Panel  par#cipants  will  reflect  the  fact  that  each  applica#on  has  2  scien#sts,  one  stakeholder,  and  one  pa#ent  assigned  to  provide  commentary  and  preliminary  scores  

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   Phase  II  Panel  Process    

Introduction Presentation

Overview and Triage Co-Chair Presents Application Synopsis

•  Chair  Introduc#on  ‒  Stress  confiden#ality  and  focus  on  impact  

•  Triage  process  to  eliminate  lowest-­‐ranked  applica#ons  from  panel  discussion  

•  SRO  captures  panel  discussion    

•  Individual  review  and  scoring  on  PCORI  Online  on  personal  laptops  

Review Scoring

Discussion of Application Open to Discussion

•  Provides  their  preliminary  impact  score  and  assessment    and  its  poten#al  for  significant  outcomes/impact  

•  All  panelists  free  to  discuss,  Chair  moderates  if  needed  

•  If  no  discussion  –  move  to  final  vote.  Reviewers  score  individually  in  PCORI  Online  

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   Triage  Process  

During  Phase  II,  a  triage  process  will  take  place:  

Ø  Applica#ons  are  ordered  according  to  ranking  (highest  to  lowest  scores)  

Ø  Lowest  scoring  applica#ons  will  be  eliminated  all  at  once  from  in-­‐person  panel  

discussion    

Ø  If  you  as  a  Reviewer  want  to  specifically  discuss  an  applica#on,  please  come  to  

the  panels  prepared  to  do  so  

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   Roles  &  Responsibili4es    

Scien4fic  Reviewers  (2)   Pa4ent  Reviewer   Stakeholder  Reviewer  

Role   Provide  addi#onal  depth  for  up  to  10  applica#ons  for  all  par#cipants  

Provides  addi#onal  depth  for    up  to  10  applica#ons  for  all          par#cipants  

Key  Responsibili4es  

Provides  their  preliminary  impact  score  and  assessment    and  its  poten#al  for  significant  outcomes/impact  

PCORI  review  is  different  because  there  is  no  primary/secondary/ter#ary  reviewer  structure  •  Also  u#lizes  different,  PCORI-­‐unique  merit  review  criteria  

Each  reviewer  must  provide  substan#ve  strengths  and  weaknesses  for  his/her  assigned  applica#on(s)    

•  Reviewers  must  be  prepared  to  speak  to  these  comments  and  scoring  during  the  in-­‐person  review  panels  

Each  panel  will  be  lead  by  a  Chair,  Co-­‐Chair,  and  SRO  in  tradi4onal  advisory  roles  

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   Time  Breakdown  per  Applica4on  

NOTE:  Panels  will  spend  no  more  than  10-­‐15  minutes  per    applica4on.  An  example:    

Ø  Some  applica#ons  may  be  reviewed  in  less  than  the  15  minutes  allocated.  

Ø  It  is  important  to  understand  the  #me  constraints  and  keep  conversa#on  focused,  pointed,  and  succinct  throughout  the  day  to  ensure  fair  and  proper  scoring  of  all  applica#ons  

Up  to…   Descrip4on  

1  minute   Co-­‐chair  briefly  introduces  applica#on  

2  minutes   Scien#fic  Reviewer  #1:  overview  and  score  

2  minutes   Stakeholder  reviewer:  overview  and  score  

2  minutes   Scien#fic  Reviewer  #2:  overview  and  score  

2  minutes   Pa#ent  Reviewer:  overview  and  score  

4  minutes   General  discussion,  if  any    

2  minutes   Take  vote  and  enter  scores  in  PCORI  Online  

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Agenda              

1.  Introduc#on  and  Announcements  

2.      Background  

5. Merit  Review:  Phase  I  –  Scien#fic  Review  

6.      Merit  Review:  Phase  II  –  Impact  Review  

7.      Merit  Review:  Phase  II  –  In-­‐Person  Panel  

3.      Program  Funding  Announcements    

4. The  Applica#on  and  Review  Process  

8.      Phase  II:  PCORI  Online  –  Process  and  Procedures  

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   PCORI  Online:  Confiden4ality  Agreement  

The  first  thing  you  will  have  to  do  upon  log-­‐in  is  agree  to  the  Confiden4ality  Agreement.  This  applies  to  both  preliminary  scoring,  and  any/all  scores  and  discussion  that  take  place  during  the  in-­‐person  review  panel.    

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   Accessing  Your  Assigned  Applica4ons  

Next,  you  will  be  able  to  see  your  list  of  assigned  applica4ons  by  selec4ng  “Review  Assignments”  in  the  side  bar  on  the  lep  side  of  your  screen.  The  list  will  appear  similar  to  below:    

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   Note  any  Conflicts  of  Interest  

Use  the  drop-­‐down  box  to  note  any  COIs.  If  there  is  a  COI,  use  the  second  drop-­‐down  box  to  indicate  type.  

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   Accessing  and  Scoring  

Once  you  have  confirmed  there  are  no  COIs,  three  new  icons  will  appear  to  the  right  of  an  assigned  applica4on:  

Ø  The  first  symbol  (farthest  to  the  lep),  a  PDF  form,  is  the  complete  applica4on  Ø  The  second  symbol  (in  from  lep)  opens  the  applica4on  abstracts  Ø  The  third,  orange  symbol  is  an  applica4on’s  Phase  I  Reviews  (scores  and  wriben  cri4ques)  Ø  The  last  symbol  on  the  far  right  opens  your  Cri4que  Form  

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   Preliminary  Scoring  in  PCORI  Online  

The  PCORI  Online  scoring  screen  for  preliminary  impact  scoring:    

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   Preliminary  Scoring:  Review  and  Submit  

Final  screen  once  preliminary  scores  are  submibed:    

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Q&A  

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Wrap-­‐Up              

This  concludes  today’s  session.  We  hope  you  found  this  training  helpful  and  informa#ve.    

Thank  you  again  for  your  commitment  to  PCORI.  

 

 

If  any  ques'ons  remain  unanswered  at  this  point,  please  email  them  to  [email protected]