Feeds:
Posts
Comments

Posts Tagged ‘ebm’

Critical  and intensive medical care is meant for supporting  an  individual organ (or multiple organs )  at times of extreme distress ,  till the  healing process  prevails over .Later , the patient  shall be shifted safely out of the unit .

Whatever be the modern technology , the single most important factor that  determines the success of ICU outcome  lies within the  patient body ( One estimate says  patient factor constitutes almost  85-90% -Dukes medical center )

Ironically , the modern gadgets, drugs , devices  threatens  . . .  rather  fights . . . with this  inherent  patient fighting  mechanism . We will  never-ever know how many cellular switches are turned on by our biological high  command ,  that compensates  and tries to restore  body  homeostasis.

critical care unit icu ccu.jpg evidecne based medicine modern medicine

Here is a  personal experience with a patient management scenario in an ICU  . The  patient is none other than my father !

He  is a 82 year old man who has  developed a acute febrile illness which rapidly degenerated into  acute respiratory failure  and  X ray  showing  infective bilateral pneumonia  and  probable ARDS  .He was on ventilator for 4 days  and subsequently weaned  off but still  heavily dependent on oxygen . His lung is wet with crackles and wheeze intermittently . His cardiac function was excellent . In one of the episodes of hypoxia he  developed  , mild shooting of blood pressure and minimal ST changes .  Alarmed  by this he was started on  beta blocker , for the first time  . It  was titrated up to maximum doses for a suspected ischemic  episode .

It is  well-known , ECG changes are extremely common in hypoxia , tachycardiac  stressed individuals .

Sympathetic  blockade  is important , only  if ,  it is an inappropriate surge  . When the body fights a disease it is the only major biological weapon available to him .How is it justified to block it ?

When this was discussed with the  team they said they have no power to deviate from  protocol and there is one article , that says  BBs are  beneficial even in COPD !

The patient  continues to be in ICU dependent on oxygen with extreme  ICU fatigue  definitely worsened by the heavy dose of adrenergic blockers which is in my opinion delaying recovery !

Different   organ specialist are prescribing  drugs  according to their level of understanding  (evidence is always available for them  . . . some where )  and radiology fellows  keep taking  snaps of  distressed  organs  in various angles  in HD quality images . Meanwhile , CT scan  seems to have revealed a chronic  interstitial  process   . . . how to diagnose a chronic lung condition  in a man who is  yet to recover from major acute inflammatory lung Injury ! I do not know ? And the current development is they are considering disseminated tuberculosis !

You may a big physician , the patient  may be a very close family member  , modern health care  system makes you watch  helplessly once you hand over  patient to a   complex care  unit .

We hope for the  best .

Final message

               Medical practice  . . . however intensive the care may be  . . .   the bottom line is  . . . it  should be based on  common sense . Modern medicine  tends  to make  this faculty of our brain  blunted .

The  specialty of Intensivist   is largely  misunderstood  . It goes more with  satisfying scientific egos  and public  perceptions  rather than true patient needs .

We need not react to every changing parameter that emanates  from the modern machines  that  keep sending out live  data from a seriously ill patient ,  on a moment  to moment  basis ! (We simply do  not need that ! If only a pilot  reacts with  jitters to every air pocket turbulence ,  he will  not reach the destination safely  ! )

From a cardiologist perspective ,  the humble  request  to all Intensivists   and critical  care physicians   is ,   avoid being  in  “fire fighting mode”   for all  those subtle ECG changes  that occur  in ICUs ,  especially with multi- system disorder (Caution : Acute coronary syndrome in CCU / post PCI  set up   is different story altogether where even a minor ST shift can be significant ! )

Heaven’s  sake  let us  rely more  in  our  brain rather than  the machines and devices !

Above story is not even a tip of an Iceberg . I come across it  every day  in  many ICUs  I visit  . The  most saddening aspect  is ,  we can not point out these mistakes  to our fellow professionals ,  as it  amounts to   hurting academic egos .They are more important  than patient care at any given point of time !

Counter point

For any system to work  , it  needs  a  strict set of guidelines ,  other wise the system of care will fail. This is a  fundamental basis on which modem medical  care works . The only issue is ,  we  should keep checking for any inadequacies in the evidence base and try to correct it. So do not blame the  EBM . It has come to stay .That is the future ! You are very pessimistic towards  modern science !

Rapid response to counter point

But the real issue is  . . . by the time next evidence base finds a major flaw  in the existing system of care ,  damages are already done . So with your clinical acumen  every learned physician is free to create  his own real world  experience .(That is also called Level 3 evidence now ) ** Protocols are not  sacred sermons . It  may  be (rather must be !)   violated if there is a need for the benefit of patient .

Disclaimer

* This is not an  attempt to disgrace the concept  of intensive  medical care . Please remember ,  finding fault  could be same as finding facts .(At least in   medical care )

 

Update ( February 24th, 2013  Sunday , 12.05  AM )

After 25 days of  intensive and aggressive  medical care   we lost one of the great lives

of modern times  which will be celebrated by his  sons and daughters forever !

Read Full Post »

Off label prescription 

  1. Is a great scientific concept
  2. Is a deceit camouflaged  with a pseudo scientific fabric.
  3. Can be encouraged in very selective patient  population and diseases by experienced  cardiologists , as  it may be really useful when no other options are available.
  4. Is diagonally opposite  to evidence based medicine , should be banned in toto !

Answer:

4 is the correct answer .occasionally 3 can be true

Some of the examples of off label indication

  • Statins for Aortic stenosis
  • VSD device for RSOV closure
  • Ivabradine for cardiac failure

By the way how does an off label become on label?

It is not the ” God ” who  gives the label to them

There are few “Demi Gods” sitting aside  in the regulatory corridors of  New york and  Geneva who decide the fate of these drugs and devices . Ultimately the integrity of these organizations that will either protect or injure our patients !

Final message

Medical science grows my mistakes  . . . hence  we should be encouraged to do more of that  . . . so that we can grow !

Read Full Post »

For  all those youngsters , who are into the mystery world of medical research  , please begin your journey with this great book.  The greatness lies in it’s  simplicity in expression & search of truth !

Download this 1 MB  marvel  ,  free from  http://www.jameslindlibrary.com  in less than a minute

Read Full Post »

  1. Do 64slice MDCT  in all patients who has  a coronary event and follow it up with catheter based CAG.
  2. Use liberally the new biochemical marker ,  serum  B-naturetic peptide (BNP) to diagnose cardiac failure in lieu of basal auscultation.
  3. Advice  cardiac resynchronisation therapy in all patients  who are in class 4 cardiac failure with a wide qrs complex .
  4. As it is may be considered a  crime to administer empirical  heparin, do ventilation perfusion scan in all cases with suspected pulmonary embolism.
  5. Do serial CPK MB and troponin levels in all patients with well  established  STEMI .
  6. Open up all occluded coronary arteries irrespective  of symptoms and muscle viability.
  7. Consider  ablation of pulmonary veins as an  initial strategy in  patients with recurrent idiopathic AF. If it is not feasible  atleast occlude their left atrial appendage with watch man  device.
  8. Never tell  your patients   the  truths  about the  diet , exercise &  lifestyle modification (That can  cure most of the early hypertension) . Instead encourage the  use of  newest ARBs  or even  try direct renin antoagonists   to treat all those patients in  stage 1 hypertension.
  9. Avoid regular heparin in acute coronary syndromes   as  it  is a disgrace to use it  in today’s world. Replace all prescription of heparin with  enoxaparine  or  still better ,  fondaparinux  whenever  possible.
  10. Finally never discharge  a  heftily  insured patient   until  he completes all the  cardiology investigations  that are available in your hospital  .

Coming soon :  10 more ways to  increase cost of cardiology care . . .beyond common man’s reach

Read Full Post »

When  a doctor is confronted by serious  doubt  ,  what will be the outcome for the patient  ?

Can  doubting  be beneficial for a patient ?  . It seems so ,  according to  EBM which  stresses   about statistical outcome at every turn of events in a  patient who  is critically  ill .

Is  something ,  always  better than  nothing   ?   Our  limbic  system tends to think so .  It  may not be true. But  in  dire situations ,   many  things  (Proven , unproven)  need to  be tried  however doubtful it ‘s  efficacy  may be  .This is  akin to an  emergency in an  airplane. Even here there need to be a logic.

Then ,this question  arises . How do we make  sure ,  we have a  dire situation on hand  ?

This is the key issue ,  in  the  decision making  for the   critically ill patients .  It  needs  experience ,  only experience !  Though the principle of uncertainty  is the fundamental rule in medicine ,   EBM  aims to bring some degree of certainty in medical therapeutics.

ebm evidence pci coronary

Benefits of doubting in coronary care unit.

In  a  sinking patient  with cardiogenic  shock  , try  the maximum treatment . Even if , the patient is  in severe shock  , take him to the  cath lab ,  try  open the coronary artery . Give the benefit of doubt  to him even though the chances of reviving him is less than 10%.

Risk of doubting in Coronary care unit.

A.Elderly STEMI  with SHT,(Arriving late ,  with  an unknown time  window  after an MI ) To thrombolyse or not ?  . There is  no benefit of doubt here.  Do not thrombolyse. Here , apply  the benefit of doubt against thrombolysis .

B. Chest pain with  LBBB (Thought to be new onset LBBB ) don’t ever rush to thrombolyse.  Wait for the enzyme result . Don’t try to thrombolyse your doubt , instead  thrombolyse the  confirmed thrombus !

C. Patient with persistent ST elevation following thrombolysis ,in an  otherwise asymptomatic and stable patient. Don’t  pass on  ” your doubt ” of salvaging   at least  some myocardium  by rescue PCI .Rescue  should be done before death. You can not resuscitate  dead myocytes.

Final message

The concept of   giving  the  benefits of doubt  to the patient   is a widely prevalent practice  in medicine .This concept is alive  and popular , not because it has proved effective, but because of the primitive   human perception and cognition  , namely “Something is better than nothing ” !

Common sense and logic would suggest , whenever  there is  a benefit  for doubting there would be a  equal (  or  even  more ) unmeasured  hazards and risks . This  becomes  especially  true ,  when   a   physician makes  a therapeutic move  based on doubting than on conviction .

Read Full Post »

Contrary to popular belief ,great things happen only rarely in medicine . It takes  only  few  months of  training  or  workshops ,  for a  wrong or inappropriate concept  to  percolate  our  brains !  But , it  would require,   decades  of  time , energy  and  efforts  ,  for  correcting  that  wrongly  assimilated concept  in medicine !

Interventional cardiologists are  among the  rare breed of physicians,   who always believe in evidence !  But ,  the quality of  the  evidence  is rarely questioned  !  30 years of PCI  & 20 years of stenting has failed  our  common senses ! Fortunately , today,  we have 135 pages of new evidence ( Not really new , old evidence interpreted with  sound logic !)

Hats off to ACC and associates for bringing out this much belated appropriateness guidelines for the interventional cardiologists.

ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness Criteria for Coronary Revascularization

A Report of the American College of Cardiology Foundation Appropriateness

Criteria Task Force, Society for Cardiovascular Angiography and Interventions,

Society of Thoracic Surgeons, American Association for Thoracic Surgery,

American Heart Association, and the American Society of Nuclear Cardiology

Endorsed by the American Society of Echocardiography, the Heart Failure Society of America, and the

Society of Cardiovascular Computed Tomography

Click here to get guidelines

http://circ.ahajournals.org/cgi/reprint/CIRCULATIONAHA.108.191768v1.pdf

If you don’t have time to read the entire document (135 pages  )

Just remember only one point

Common sense,  more  often  prevails  over  evidence ,  in medicine . Apply it  , frequently  in your patients .They will reep the benefits !

Read Full Post »

CURRENT   CARDIOLOGY  PRACTICE: EVIDENCE  OR  EXPERIENCE  BASED ?    AN  ANALYSIS OF  ACC/AHA  GUIDELINES.

S. Venkatesan,  Madras Medical College. Chennai

 

If  a  major therapeutic procedure is adviced based on simply by experience or expert opinion  how can we say evidence based medicine is practiced !

 

                                    Evidence based cardiology  is  the  buzz word  in global cardiovascular  health care  organizations. All diagnostic  and therapeutic  interventions are  undergoing  rigorous randomized  trials  for  proof of  efficacy  and  safety. ACC/AHA   have published  management guidelines and it  has been accepted  as de-facto standard of clinical cardiology practice world wide.  In these guidelines  class  1  indication  is defined as Conditions for which there is evidence for and/or general agreement that the procedure is useful and effective. These indications are supported by three levels of evidence.(A,B,C) .It has been observed,   many of the recommendations  in  class 1  were supported by only level  C  evidence. (Expert consensus or  agreement  ). We  analysed how much of todays guidelines is  agreement based  and  how much is evidence based. The  latest  practice  guidelines  of  ACC/AHA   for  Acute myocardial infarction , Unstable Angina and Non–ST-Segment Elevation Myocardial Infarction , chronic  stable angina  ,coronary angiography  were analysed. The  no  of  class 1  indications  were counted  in each set of guidelines  and  each  of the indication were  sub grouped with reference to the  levels of  evidence  to which it was supported. There  were a total  of 210  class 1  indications.

  

 

Class  1

Level A

Class   1

Level  B

Class  1

Level  C

P value

1A vs 1C

AMI(54)

7

25

22

<.0001

UA  (66)

11

26

29

<.0001

CSA(59)

8

29

22

<.0001

CAG(31)

3

12

16

<.0001

Total(210)

29(13.9%)

92(43.8%)

89(42.4%)

<.001

 13.9%   of class 1  indications were based on  level  A evidence.  42.4%  of class 1 indication were based  on Level C  ( agreement  of experts).Though evidence based cardiology   is   considered  to  define  the  standards in  Cardiology  practice  in reality  we lack evidence in most of the situations. 

                                       We  conclude  that  consensus or  agreement  based cardiology  practice is the dominant theme in current   ACC/AHA 

Read Full Post »

All is not well,  that ends well !

                                       Treatment guidelines in cardiology  practice  are periodically published by ACC/AHA/ESC.These guidelines  represent the current scientific practice. They are called some times as recommendations. Medical professionals tend to adhere to this guidelines whenever possible.They are not legally binding in most of the countries.In USA some states believe it, to be legally binding.

 

The problem with these guidelines  are , they are classified as class 1 ,class 2 , class 3 recommendations.

 

Class 1, A  drug , device  or a procedure  Is definitely useful and must be prescribed.

Class 3,   A  drug , device  or a procedure  Is not useful and should not be used .

Class 2*, A  drug , device  or a procedure  may be useful  or may be harmful , and hence may be used or may not be used . (Vaguest possible guideline!)

 *Altered to convey the meaning

What are the  guideline violations that can be sued in court of law  ?

A person with established  CAD who is not been prescribed a  statin (Cholesterol lowering drug)  can be sued straight away,  even if the patient has no adverse outcome due to the nonprescription of that drug. The issue here is , the doctor  has not prescribed  a drug which has  proven benefit .The law is clear on that .Most will  agree that,  the  doctor is at fault ,  and he  is never protected  even by their  colleagues .He  can’t defend his action.

What are the medical errors that can never* be sued in court of law !

But the same doctor who opens up a totally occluding coronary artery in an asymptomatic patient(CTO -chronic total occlusion) and lands up  in a complication and the  patient dies. This could be  major guideline violation as opening a CTO in an incidentally detected , asymptomatic patient is a class 3 recommendation. Neither the physician, patient , institution  nor  the regulatory authorities bother about this even though there is strong case for censure , in reality it never happens. Number  of  experts from leading hospitals do this procedure in live work shop all over the world with full media glare, It is an irony the same  experts are only  writing  in their  guidelines  that  these procedures should not be done inappropriately.

And this medical  error ( Should we call it a  crime if it is knowingly done ! )   keeps growing as the physician never feels guilty about it .

The message here is

 A physician of a state of the art hospital,  in a scientifically advanced  country  goes scott free and guilt free  even if he openly violate the scientific guidelines and do a inappropriate procedure that result in a patient death. Mean while a small time physician in a remote place in the same country can be taken to task  for not prescribing a officially  recommended drug (By standard guidelines) .He will be labelled unscientific and unethical even if his non prescription , had not caused any untoward health outcome .

In short , in today’s modern medical practice 

 Even a  ” Minor error of  ommision”   attracts guilt and perceived fear among the physicians. Meanwhile  many  of the ” Major errors of commission”  done by professionals are rarely frowned upon and thus these  mistakes continue to perpetuate !

*There should be a strong provision in medical law to address the issue of inappropriate procedures even if the procedure has not resulted any untoward effect to the patient.

Read Full Post »

 

Is it a crime to do a plain balloon angioplasty in 2008 ?

Plain balloon angioplasty,   the greatest  innovation in   cardiology  when it was introduced in 1977 in a Zurich cath lab , has now become an  ugly  word for most of the cardiologist !

Why this turn around ?  Has technology ,  really overtaken a great procedure and made it obsolete now ?

The answer is a definite ” No”

The restenosis which was the villian in the plain old angioplasty has never been overcome even today. Stents initally used as a bail out procedure during  abrupt closure , later it was used conditionally, followed by provisional stenting and now in 2008  we are made to believe  it is mandatory.

When we realised , bare metal stents are equally  bad (If not slightly better ) in arresting the restenosis drug eluting stents came into vogue with a big bang in 2002. It was projected as the ultimate breakthrough in interventional cardiology and  in 5 years the truth was exposed and it not only failed to prevent the restenois but also had a dreaded complication of acute stent thrombosis.

Now we know , metals  inside a coronary artery  carry  a life long  risk of sudden occulusion , and we talk about biodegradable stents (With poly lactic acid ).

 Common sense ( Unscientific truths)  would suggest

Plain balloon angioplasty still has a major role in our global  cardiovascualr population.

Since restenosis is the  only issue here, ( about 30% )  we can choose patients in whom even if restenosis is likely to happen  no major harm is done . A vast majority of chronic stable angina patients  fall in this category.

Aggressive lipid lowering with plain  balloon angioplasty has never been tested properly . In future also it is unlikely,  such trials will be done as it would be considered unethical . But that would be a premature conclusion.

The other major issue is the cost of stenting , the procedure of PCI/PTCA  has become unaffordable for most of the population in developing countries .The primary reason being the PCI without stenting is considered  ” A untouchable” . If only we remove this stigma from the cardiology community   a signiificant population will be benefited.

A patient with chronic stable angina treated with POBA ,if develop further angina after few years , he  is likely to get a recurrence of  relatively safe  stable angina.  While in a post PCI patient  any angina after the procedure becomes a unstable angina ( Braunwald classification)  and requires emergency care . Angina in a  stented patient is can not be taken lightly as  the the course of angina is unpredictable .

POBA in primary PCI ?

Many may think it is a foolish idea . It has been found many times,  when we rush the pateint to   cath lab after a STEMI  we are in for a surprise !. About 30% of times it is a very complex lesion profile  like diffuse disese,  tight bifurcation lesions , loaded with thrombus or a left main disese.

We fail to realise a basic  fact  , the  initial aim of primary PCI is to salvage the myocardium ,and the next comes the prevention of restenosis . It may even , be argued salvaging  myocardium is the only aim ! Myocardial salvage sould be done urgently . And even  removing the thrombus and opening a IRA can be suffice in a patient who is crashing on table.  Of course stenting can be done whenever possible. But for IRAs which has complex anatomy attempting a perfect stent PCI   (Some may require more than few stents)  as an emergency procedure invariably affects the outcome. One should spend  shortest possible time  inside the  illfated coronary artery. Prolonged manipulations within the coronary artery in an unstable patient  aiming at  longterm patency of an IRA  is to be avoided .The pending procedures can always planned in a next stage. 

Final message

So it is not a crime to think about plain balloon  angioplasty  in some of  our  patients  with acute or chronic coronary syndromes .  Hope Gruentzig  is listening from the heaven and hopefully agree with me !

Dr.S.Venkatesan, madras medical college, chennai, India .

Read Full Post »

Peer review of an article even in major journals never scrutinise the “Aim of  a study ” . However big is the journal,  they seem to bother only about the authors, materials, methods, and statistical analysis.  If only they peer review an article , right from the “Aim of the study” like ,

  • Who asks the research questions?
  • Who  defines the aim of the study ?
  • Who decides which drug to be compared with which drug ?
  • Who steers the steering commitee of a trial ?

If only , we could answer these questions without bias , pharma industry and their  regulators  would have ,  far more better image than what they have now !

A typical example for , the aim of the study  to be  wrong  , is  the “ONTARGET’ study on telmisartan.

Here they ( Who ? ) raised an inappropriate  question of     “Non inferiority” of one drug with other  without any  valid reason to compare these two drugs that will benefit the man kind !

Read Full Post »