Professor Soo Downe

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Information about Professor Soo Downe

Published on September 21, 2015

Author: HannahStockdale


1.  ‘Which  horses  for  which  courses?    The  EBM  Problem  in  studies  of   pharmacological  substances  in  maternity   care     Soo  Downe   University  of  Belfast   September  10th  2015     Alcohol  &  Medica-ons  in   Pregnancy:  Sharing  Research   Evidence  on  Recrea-onal  and   Prescribed  Substances.   Penthouse  Suite,  Europa  Hotel   Belfast.     With  thanks  to  all  who  gave   permission  for  their  images  to   be  used  

2. CreaGng  formal  acceptable  knowledge  

3. •  Theory-­‐pracGce  gap   •  ‘Ivory  towers’  and   real  life…  

4. On  the  high  ground,  manageable  problems   lend  themselves  to  soluGon  through  the   applicaGon  of  research  method  and  theory…

5. ‘In  the  swampy  lowland,   messy  confusing   problems  defy  technical   soluGon..  [these  are]… the  problems  of  greatest   human  concern’   Schon  1983  The  Reflec1ve  Prac11oner:   How  professionals  think  in  ac1on.   London:  Temple  Smith, p14

6. Impact  of  medicaGons  during   pregnancy  on  the  fetus   …A  2011  study  of  medica1ons  approved  by   the  Food  and  Drug  Administra1on  (FDA)   from  1980  through  2010  found  that  91%  of   the  medica1ons  approved  for  use  in  adults   lacked  sufficient  data  to  determine  the  risk   of  birth  defects  due  to  use  of  [those]   medica1ons  during  pregnancy….  

7. Why  this  maSers…   DiethylsGlbestrol  (DES)   •  Oestrogen  mimic     •  Used  from  the  1940s  to  the  1970s  to  prevent   miscarriage.     Impact  on  1st  genera1on   •  Increased  risk  of  breast  cancer  (approximately   doubled  in  exposed  women).    

8.   US   NaGonal   Cancer   InsGtute   DES   follow-­‐up   study:   1992   onwards   (Hoover  et  al   2011)  

9. How  did  we  know  this?   “Our  study…documents  elevated  risk  for  DES-­‐exposed   daughters  for  a  host  of  medical  problems—many  of   them  also  quite  common  in  the  general  populaGon… Without  the  senGnel  finding  of  a  very  rare  cancer  in   young  women,  and  without  the  sustained  follow-­‐up  of   those  who  were  exposed,  we  would  not  know  the  full   extent  of  harm  caused  by  DES  exposure  in  the  womb.”   Robert  N.  Hoover,  M.D.,  director  of  the  Epidemiology  and   Biosta1s1cs  Program  in  NCI’s  Division  of  Cancer  Epidemiology   and  Gene1cs.    

10. Impact  on  future  generaGons…   ?  EpigeneGc  influence?   Impact  on  3rd  genera1on   •  QuesGonnaire  to  793  women  whose  mothers  had  documented  in-­‐ utero  DES  exposure.   •  Mean  age  of  menstruaGon  the  same   •  Daughters  of  exposed  women  regularized  menstruaGon  later     (mean  16.2  years  vs.  15.8  years;  p  =  0.05),     •  More  likely  to  report  irregular  menstrual  periods   (  OR  =  1.54    (95%  CI  1.02-­‐2.32))   •  Daughters  of  exposed  women  had  fewer  live  births  (1.6)  than  the   unexposed  (1.9)  (P  =  0.005).  

11. The  current  situaGon  in  terms  of  drugs  and   pregnancy  (USA)     (Adam  et  al  2011)   •  Majority  of  women:  at  least  one  medicaGon  during   pregnancy   •  Review  of  safety  of  172  drugs  approved  by  FDA  from  2000   to  2010,  and  468  drugs  approved  1980-­‐2000     •  TERIS  risk  raGng  system   •  Teratogenic  risk  in  human  pregnancy  "undetermined"  for   168  (97.7%)  of  drug  treatments  approved  between  2000   and  2010.   •  No  data  regarding  safety  available  for  126  (73.3%)  of   these  drugs.    

12. We  are  doing  beSer  now…?   (Adam  et  al  2011  cont)   Drugs  approved  between  1980  and  2000:  only  23  (5%)  changed  a   full  risk  category  or  more  in  the  past  10  years.     Revised  risks  were  derived  from:      exposure  cohort  studies/record  linkage  studies,      teratogen  informaGon  services,      large  populaGon-­‐based  case-­‐control  studies    pregnancy  registries                (animal  studies?)     The  mean  Gme  for  a  treatment  to  move  from  an  "undetermined"   risk  to  be  assigned  a  more  precise  risk  was  27  years  (95%   confidence  interval  26-­‐28  years)  

13. Unknown  unknowns…  

14. Pregnant  women  who  need  medicaGon..     Women  with  epilepsy  (+/-­‐  anG-­‐epilepGcs)  vs  no   epilepsy     .     outcome   OR   95%  CI  for  OR   miscarriage   1.54   1·∙02-­‐2·∙32   APH   1.49   1·∙01-­‐2·∙20   PPH   1.29   1·∙13-­‐1·∙49   Hypertension   1.37   1·∙21-­‐1·∙55   InducGon   1.67   1·∙31-­‐2·∙11   CS   1.40   1·∙23-­‐1·∙58   Preterm  birth   1.16   1·∙01-­‐1·∙34   Fetal  growth   restricGon   1.26   1·∙20-­‐1·∙33  

15. RouGne  use  of  medicaGon  for  all/most:   and  what  about  labour?   •  Short  term  benefits/long   term  risks?   •  Why  are  drugs  our  default   posiGon?   •  AlternaGves  with  less   risks?   –  InducGon  of  labour  to  reduce  CS   in  healthy  women  and  babies  (:   OR   –  RelaGonship  based  conGnuity  of   care/out  of  hospital    birth   (added  benefits  for  preterm   birth)  

16. ‘AlternaGve’  sesngs  (Cochrane  review)   Hodnett ED, Downe S, Walsh D, Weston J 2010" •  for  the  care  of  pregnant  women   who  prefer  and  require  liSle  or   no  medical  intervenGon.   •   The  sesngs  may  offer  care   throughout  pregnancy  and   birth,  or  only  during  labour;     •  they  may  be  part  of  hospitals  or   freestanding  enGGes.    

17. AlternaGve  sesngs:  findings     10 trials; n = 11795 -­‐ reduced  likelihood  of  medical   intervenGons   -­‐ increased  likelihood  of  :   -­‐  spontaneous  vaginal  birth,   -­‐  maternal  saGsfacGon   -­‐  conGnued  breasueeding  at  1-­‐2   months  postpartum   -­‐   no  risks  to  mother  or  baby.  

18. Birthplace  UK   •  Birth  is  generally  very  safe  (4.3/1000  adverse  events).   •  MLU’s  (alongside  or  freestanding:    safe  for  the  baby,  benefits  for   the  mother   •  significantly  fewer  intervenGons,  (fewer  intrapartum  caesarean   secGons,  and  more  ‘normal  births’)  than  planned  birth  in  an   obstetric  unit.   •  Mul-parous  women:  home  births  and  midwifery  unit  births  safe   for  the  baby,  benefits  for  the  mother    

19. Midwife  led  care:  evidence     Sandall  et  al  2013   •  13  trials  involving  16,242  women       •  Women  who  had  midwife-­‐led   conGnuity  models  of  care  were  less   likely  to  experience:   –  regional  analgesia  (RR  0.83,  95%  CI  0.76  to   0.90)   –  episiotomy  (  RR  0.84,  95%  CI  0.76  to  0.92),     –  instrumental  birth  (RR  0.88,  95%  CI  0.81  to   0.96)     –  preterm  birth  (  RR  0.77,  95%  CI  0.62  to  0.94)   –  fetal  loss  before  24  weeks'  gestaGon    RR   0.81,  95%  CI  0.66  to  0.99),    

20. Sweden  oxytocin  outcomes:  neonate   Effects  of  induc1on  and  augmenta1on   •  Oxytocin  use  and  Apgar  score   <  7  at  5  min   –  OR  2.3;  95%  CI  1.8-­‐2.9   •  Need  for  neonatal  intensive   care                         –  OR  1.6;  95%  CI  1.5-­‐1.7)   •  OperaGve  birth     –  OR  4.0;  95%  CI  3.7-­‐4.2).  

21. Longer  term  risks  of  the  use  of  oxytocin?    Induced  foals  up  to  10  days  postnatal   (Holdstock  et  al  2012)   •  Differences  in  pancreaGc  endocrine   cell  funcGon  with  delivery  method   were  associated  with  2-­‐3  fold   higher  corGsol  levels  in  the  induced   foals  and  with  differences  in  the   absolute  and  age-­‐related  changes   in  basal  concentraGons  of  glucose,   alpha-­‐amino  nitrogen  and  insulin.   •  Induced  delivery  leads  to  changes   in  pancreaGc  beta  cell  sensiGvity  to   glucose  and/or  Gssue  insulin   resistance  in  associaGon  with   persistent  neonatal   hypercorGsolaemia.  

22. …pregnancy  and  birth  intervenGons  and  non-­‐ communicable  disease…?   •  ?Feedback  loops  between  the  hormonal/ physiological    effects  of  pregnancy  and  birth  and   outcomes  for  the  baby  in  later  life:   •  Type  1  diabetes     •  Eczema   •  Asthma   •  MulGple  sclerosis   •  Some  cancers  (esp  acute  lymphoblasGc   leukemia)   •  Obesity   •  Etc….   •  …changes  in  white  blood  cell  DNA-­‐methylaGon  in   cord  blood  

23. Complex  interplay  between  genes,  epigeneGcs,  life   experiences,    and  our  ‘Old  Friends’?  

24. What  the  World  Health  OrganisaGon  says:     •  ….Generally,  between  70  and  80%  of  all   pregnant  women  may  be  considered  as   low-­‐risk  at  the  start  of  labour.     •  ….The  uncriGcal  adopGon  of  a  range  of   unhelpful,  unGmely,  inappropriate   and/or  unnecessary  intervenGons,  all   too  frequently  poorly  evaluated,  is  a   risk  run  by  many  who  try  to  improve   the  maternity  services…..   WHO  hSp:// MSM_96_24_Chapter1.en.html  

25. Taking  account  of  the  mother  baby  dyad:   InverGng  the  evidence  hierarchy  for   pharmacological  research…?   •  Cohort  studies   •  Case-­‐control  studies   •  PragmaGc  RCT’s…   •  (mulGmethod)     systemaGc  reviews..    

26. SystemaGc  reviews  with  individual  level   data  

27. N  of  one  (?two?)  studies  

28. Personalised  medicine  

29. Taking  account  of  placebo…   Studies  of  doctors  and  diabeGc  paGents   Hojat  et  al  2013   •  Study  one:  29  family  physicians.  891  paGents  (USA)   –  physicians’  higher  scores  on  the  Jefferson  Scale  of  Empathy    significantly   associated  with  indicators  of  diabeGc  control     •  Study  two:  242  general  pracGGoners,    20  961  paGents  (Italy)     –  associaGon  between  higher  physician  empathy  and  lower  incidence  of   acute  metabolic  complicaGons  that  required  hospitalisaGon  

30. The  real  effect  of  placebo   even  in  randomised  trials     (issues  of  generalisibility  of  size  of  effect?)   •  Pain  relief  scores.     •  5  placebo-­‐controlled  single-­‐dose  parallel-­‐group   RCTs  in  acute  postoperaGve  pain     •  130/525  had  a  placebo.   •  Scores  varied  from  0  to  100%  maximum  possible   pain  relief.     •  >  50%  maximum  possible  pain  relief  across  trials:   –  7%  to  37%  with  placebo   –  5  to  63%  with  acGve  drugs      

31. Untangling  to  Gordian  knot:   Finding  out  what  works…beyond  RCT’s     •  Full  range  of  standard   quanGtaGve  methods   •  QualitaGve  research   •  Realist  research   •  Mixed  methods…   •  Views  of  stakeholders,   including  service  users  

32.   Gesng  the  balance  right..    

33. From  knowledge  hierarchies  to  a   knowledge  matrix   Pescrew  M  Roberts  H  2003  Evidence,  hierarchies,  and  typologies:  horses  for  courses  J  Epidemiol   Community  Health  2003;57:527-­‐529    

34. Horses  for  courses:     squaring  the  circle  

35. Adam  MP1,  Poli~a  JE,  Friedman  JM.  Evolving  knowledge  of  the  teratogenicity  of   medicaGons  in  human  pregnancy.  Am  J  Med  Genet  C  Semin  Med  Genet.  2011  Aug   15;157C(3):175-­‐82.  doi:  10.1002/ajmg.c.30313.  Epub  2011  Jul  15.     Hojat  M,  Louis  DZ,  Maio  V,  Gonnella  JS.  Empathy  and  health  care  quality.   Am  J  Med  Qual.  2013  (1):6-­‐7.  doi:  10.1177/1062860612464731.       Holdstock  NB,  Allen  VL,  Fowden  AL.  PancreaGc  endocrine  funcGon  in  newborn   pony  foals  a€er  induced  or  spontaneous  delivery  at  term.  Equine  Vet  J  Suppl.  2012   Feb;(41):30-­‐7.     Hoover  RN,  Hyer  M,  Pfeiffer  RM,  Adam  E,  Bond  B,  Cheville  AL,  Colton  T,  Hartge  P,  et   al.  Adverse  Health  Outcomes  in  Women  Exposed  In  Utero  to  DiethylsGbestrol.   NEJM.  Oct.  6,  2011.  6,500  women  (4,600  exposed  and  1,900  unexposed),     Lillie  EO1,  Patay  B,  Diamant  J,  Issell  B,  Topol  EJ,  Schork  NJ  The  n-­‐of-­‐1  clinical  trial:   the  ulGmate  strategy  for  individualizing  medicine?  Per  Med.  2011  Mar;8(2): 161-­‐173.     McQuay  H  Carroll  D  Moore  A    VariaGon  in  the  placebo  effect  in  randomised   controlled  trials  of  analgesics:  all  is  as  blind  as  it  seems  Pain  64  (  2)  331–335    

36.   Oscarsson  ME,  Amer-­‐Wåhlin  I,  Rydhstroem  H,  Källén  K.  Outcome  in  obstetric  care  related  to   oxytocin  use.  A  populaGon-­‐based  study.    Acta  Obstet  Gynecol  Scand.  2006;85(9):1094-­‐8.     Reed  CE,  Fenton  SE.  Exposure  to  diethylsGlbestrol  during  sensiGve  life  stages:  a  legacy  of   heritable  health  effects.  Birth  Defects  Res  C  Embryo  Today.  2013  Jun;99(2):134-­‐46.  doi:   10.1002/bdrc.21035.     Schlinzig  T,  Johansson  S,  Gunnar  A,  Ekstr!  TJ,  Norman  M  EpigeneGc  modulaGon  at  birth  -­‐   altered  DNA-­‐methylaGon  in  white  blood  cells  a€er  Caesarean  SecGon.  Acta  Paediatr.  2009  Jul; 98(7):1096-­‐9.     Schon  1983  The  ReflecGve  PracGGoner:  How  professionals  think  in  acGon.  London:  Temple   Smith,  p14     Titus-­‐Ernstoff  L,  Troisi  R,  Hatch  EE,  Wise  LA,  Palmer  J,  Hyer  M,  Kaufman  R,  Adam  E,  et  al   Menstrual  and  reproducGve  characterisGcs  of  women  whose  mothers  were  exposed  in  utero   to  diethylsGlbestrol  (DES).”.  Interna1onal  Journal  of  Epidemiology  2006    35  (4):  862–8.       Viale  L1,  Allotey  J2,  Cheong-­‐See  F2,  Arroyo-­‐Manzano  D3,  Mccorry  D4,  Bagary  M5,  Mignini,   Khan  KS6,  Zamora  J7,  ThangaraGnam  S6;  EBM  CONNECT  CollaboraGon.  Epilepsy  in  pregnancy   and  reproducGve  outcomes:  a  systemaGc  review  and  meta-­‐analysis.  Lancet.  2015  Aug  25.  pii:   S0140-­‐6736(15)00045-­‐8.  doi:  10.1016/S0140-­‐6736(15)00045-­‐8.  [Epub  ahead  of  print]          

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