Evidence Based Medicine: Reflections on Child Psychiatry

Practice

Prof.  Dr.  Yankı  Yazgan    

Terminology

Evidence:  •  The  sum  of  empirical  knowledge  available  on  a  certain  issue  derived  from  adequately  designed  clinical  trials    

•  contrast  to:  «it  is  evidence  for  me  based  on  what  I  have  seen»    

•  Especially  clinicians  use  the  term  tradiEonally  as  a  synonym  for  their  personal  clinical  observaEons  and  experiences  or  the  clinical  experiences  of  a  group  of  clinicians.  

The importance of evidence

• In  the  1980s,  there  were  large  variaEons  in  the  amount  of  care  delivered  to  similar  populaEons  

•  variaEons  in  rates    • of  prostate  surgery  and  hysterectomy  of  up  to  300%    • performance  of  cataract  surgery  was  2000%.      

Why??   same  textbooks    

Same  journal  arEcles    high  VariaEon  rates  

The importance of evidence

•  clinicians  confront  quesEons  about  the:  •  interpretaEon  of  diagnosEc  tests,    •  the  harm  associated  with  exposure  to  an  agent,    •  the  prognosis  of  disease  in  a  specific  paEent,    •  the  effecEveness  of  a  prevenEve  or  therapeuEc  intervenEon,    •  the  costs  and  clinical  consequences  of  many  other  clinical  decisions.    

The importance of evidence

•  clinicians  and  policy  makers  need  to  know    •  whether  the  conclusions  of  a  systemaEc  review  are  valid,    •  and  whether  recommendaEons  in  pracEce  guidelines  are  sound        

     This  is  where  Evidence-­‐Based  Medicine  comes  in  

Evidence-based medicine (EBM) •  The  conceptualizaEon,  ideals,  and  guidelines  that  have  become  evidence-­‐based  pracEce  emerged  first  in  the  medical  field  as  evidence-­‐based  medicine  (EBM)  (Reichow,  B  et  al,  2010)  

•  EBM:  “the  conscienEous,  explicit,  and  judicious  use  of  the  best  evidence  in  making  decisions  about  the  care  of  individual  paEents”  (Law,  MC  et  al,  2008)  

 

•  Evidence  in  the  sense  of  EBM  is  the  result  of  a  criEcal  and  systemaEc  overall  evaluaEon  (‘criEcal  appraisal’)  of  (published)  results  of  scienEfic  studies.  (Möller,  HJ  et  al,  2010)  

Evidence-based medicine (EBM) Drake  et  al.  (2005)  suggest  EBM  is  based  on  five  principles:    

1.  a  foundaEon  of  the  philosophy  and  ethics  of  basic  values;    2.  the  need  to  consider  scienEfic  evidence  as  an  important  factor  in  decision  

making;    3.  the   realizaEon   and   recogniEon   that   scienEfic   evidence   is   complicated,  

hierarchical,  oaen  ambiguous,  and  usually  limited;    4.  the  recogniEon  that  factors  other  than  scienEfic  evidence  (including  client  

values)  are  important  in  decision  making;  and    5.  the   recogniEon   that   clinical   experEse   is   an   important   factor   in   decision  

making.    Reichow,  B  et  al,  2010  

EBM/EBP

•  ‘EBM’  and  ‘EBP’  are  oaen  used  interchangeablyàconfusion  •  EBM  is  applying  the  best  evidence  that  can  be  found  in  the  medical  literature  to  the  paEent  with  a  medical  problem,  resulEng  in  the  best  possible  care  for  each  paEent.    

•  Evidence-­‐based  clinical  pracEce  (EBCP)  is  a  definiEon  of  an  approach  to  medical  pracEce  in  which  you  the  clinician  are  able  to  evaluate  the  strength  of  that  evidence  and  use  it  in  the  best  clinical  pracEce  for  the  paEent  sidng  in  your  office.  

•  EBM,  focuses  only  on  research  evidence  and,  in  contrast  to  EBP,  does  not  extend  to  other  factors  in  clinical  decision-­‐making.  

EBP  is  a  mulDstep  process:  1.  FormulaEng  a  quesEon  at  the  level  if  the  individual  or  populaEon  of  concern  

relaEng  to  what  one  is  trying  to  achieve.    •  two  acronyms  are  frequently  used  to  guide  the  quesEon  making:    

•  problem,  intervenEon,  comparison  (if  appropriate),  outcome    •  paEent,  exposure  to  intervenEon,  control  group,  outcome,  and  Eme  course      

2.  Searching  and  finding  the  evidence  related  to  this  quesEon.  3.  CriEcally  appraising  the  evidence  yielded  in  the  search.    

•  including  evidence  grading  schemes,  systemaEc  reviews  ,meta-­‐analysis,  best-­‐evidence  synthesis,  reviews  of  meta-­‐analyses,  and  other  systemaEc  reviews    

4.  Taking  the  results  of  the  synthesis  and  making  a  decision  for  pracEce.  5.  Monitoring  the  success  or  failure  of  the  pracEce  that  was  implemented    

•  To  make  it  effecEve  and  efficient  (depending  on  feedback)  

Evidence-based medicine (EBM) •  EBM  as  a  mulE-­‐step  process  involving  the  best  current  evidence,  clinical  experEse,  and  paEent  choice.  (Volkmar,  FR  et  al,  2010)  

Haynes,  RB  et  al,  2002  

•  EBM  can  be  seen  as  a  combinaEon  of  three  skills;  •  Mastery  (IM),  the  skill  of  searching  the  medical  literature  in  the  most  efficient  manner  to  find  the  best  available  evidence  

•  CriEcal  Appraisal  (CA)  of  the  literature.  This  set  of  skills  will  help  you  to  develop  criEcal  thinking  about  the  content  of  the  medical  literature    

•  the  results  of  the  informaEon  found  and  criEcally  appraised  must  be  applied  to  paEent  care  in  the  process  of  Knowledge  TranslaEon  (KT)  

Evidence-based medicine (EBM)

•  a  new  model  for  evidence-­‐based  clinical  decision  making,  •  based  on  paEents'  circumstances,  paEents'  preferences  and  acEons,  and  best  research  evidence,  with  a  central  role  for  clini-­‐cal  experEse  to  integrate  these  components.  

Evidence-based medicine (EBM)

• The  evidence  may  refer  to  various  areas  such  as  diagnosis  or  treatment.    

• The  two  most  important  approaches  to  determining  evidence:  

•  systemaEc  reviews                          and  then  transposed  by  specialist  groups                              into  recommendaEons  and  guidelines  

• meta-­‐analyses  

         

approaches to determine evidence •  SystemaEc  reviews:  present  in  a  narraEve  form  a  criEcal  overview  and  qualitaEve  evaluaEon  of  the  studies  available  on  a  certain  topic.    

• Meta-­‐analyses:  combine  quanEtaEvely  the  results  of  studies  on  a  specific  subject  of  interest  judged  to  be  methodologically  adequate  for  inclusion.    

• Both  procedures  should  be  regarded  complementarily.    

EBM and Psychiatry

•  Since  the  1990s,  EBM  has  become  an  important  part  of  quality  improvement  and  quality  assurance  in  psychiatry  

•  parEcularly  in  the  area  of  psychopharmacotherapy.  

• Clinical  psychiatry  involves  making  difficult  decisions  about  diagnosis,  therapy  and  prognosis.    

• psychological  medicine  need  to  cope  with  challenges  that  are  unique  to  its  nature  and  methods  

•  It  deals  with  mind  rather  than  brain.    

EBM and Child Therapy

• RelaEvely  brief  history.    

•  The  earliest  reviews  of  the  therapy  literatüre:  •  1957  [18  studies],    •  1963  [22  studies]  

àThe  reviews  concluded  that  therapy  did  not  seem  to  be  more  effecEve  than  the  passage  of  Eme  without  formal  intervenEon  (i.e.,  no  therapy).  

EBM and Child Therapy

•  ~  10%  to  20%  of  youths  meet  diagnosEc  criteria  for  a  mental  health  disorder,    

•  Among  those  only  20%  to  30%  receive  specialized  care  •  They  receive  mental  health  services  across  many  different  service  contexts  (e.g.,  schools,  child  welfare,  juvenile  jusEce,  health  care,  substance  abuse),  but  numerous  studies  document  that  collecEvely  the  need  for  services  outpaces  the  receipt  of  services  (Geddes  J,  1997)  

EBM and Child Therapy

•  2  major  components  of  evidence-­‐based  pracEces  for  children:  •  psychometrically  sound  assessments    

•  Assessment  is  required  for  accurate  idenEficaEon  of  children’s  problems  and  disorders,  ongoing  monitoring  of  response  to  intervenEons,  and  evaluaEon  of  outcomes.  

•  evidence-­‐based  intervenEons    

•  a  meta-­‐systems  framewor  for  the  delivery  of  EBP  for  children  and    adolescents  provides  a  more  comprehensive  understanding  of  the  many  contexts  that  shape  children’s  development  and  reflect  society’s  responses  to  their  needs.    

Evidence-based guidelines for mental, neurological, and substance use disorders in low-and middle-income countries: summary of WHO recommendations

•  The  treatment  gap  for  mental,  neurological,  and  substance  use  (MNS)  disorders  is  more  than  75%  in  many  low-­‐  and  middle-­‐income  countries.    

•  In  order  to  reduce  the  gap,  the  World  Health  OrganizaEon  (WHO)  has  developed  a  model  intervenEon  guide  within  its  Mental  Health  Gap  AcEon  Programme  (mhGAP).    

•  The  model  intervenEon  guide  provides  evidence-­‐based  recommendaEons  developed  with  the  Grading  of  RecommendaEons  Assessment,  Development  and  EvaluaEon  (GRADE)  methodology.  

Evidence-based guidelines for mental, neurological, and substance use disorders in low-and middle-income countries: summary of WHO recommendations

Evidence-based guidelines for mental, neurological, and substance use disorders in low-and middle-income countries: summary of WHO recommendations

Evidence-based guidelines for mental, neurological, and substance use disorders in low-and middle-income countries: summary of WHO recommendations

•  Food  and  Drug  AdministraDon  (FDA):  is  a  federal  agency  that  is  responsible  for  protecEng  and  advancing  the  public’s  health,  including    approving  and  regulaEng  medicaEon.    

•  To  gain  approval  from  the  FDA,  a  drug  must  be  shown  to  be  safe  and  effecEve  through  a  mulE-­‐stage  clinical  trial  process.  

Drugs and EBM

•  example  of  an  applicaEon  of  evidence  standards  to  the  treatment  of  auEsm  in  the  medical  field:  

•  the  approval  of  risperidone  for  the  treatment  of  irritability  (i.e.,  serious  behavioral  problems)  in  children  and  adolescents  with  auEsm  between  the  ages  of  five  and  16  (McDougle  et  al.  2005;  Scahill  et  al.  2007).    

•  aripiprazole  was  also  approved  for  the  treatment  of  irritability  in  individuals  with  auEsm  aged  between  six  and  17  (Bristol-­‐Myers  Squib  2009).    

Drugs and EBM

Treatment Efficacy -Autism-