Poor quality of Indian clinical practice guidelines : academic elitism, capacity gaps and poor governance key factors

Guideline development has changed internationally with greater stress on the use of rigorous, transparent and evidence-based methods. Guideline development in India has come under increased scrutiny with a growing interest in the use of evidence for guideline development. The National Health Policy 2017 lays stress on the use of evidence in clinical practice guidelines. Quality guidelines are also a prerequisite for Clinical Establishment Act to be implemented too.
Last week we published a study in the Journal of Evidence Based Medicine which explored the issue of guideline quality in India.  (Link)
In the study , we first searched for   all guidelines for four diseases with highest overall burden in India (ischemic heart disease, lower respiratory infections, chronic obstructive pulmonary diseases, tuberculosis) and appraised their quality using an internationally validated tool called AGREE II(WHO also uses it ensuring quality in the guidelines they make). This tool evaluates the guideline quality in six domains and overall domain.
In general we found was that overall Indian guidelines were rated very poorly in 4 of the 6 domains – stakeholder involvement , editorial independence(conflict of interest and funding management), methodological riguor of development, and applicability (pertains to the likely barriers and facilitators to implementation, strategies to improve uptake, and resource implications of applying the guideline) .
We then set out to interview people who developed this guidelines to understand why this was happening and found :
that the key reasons were ;
  • Guideline development was seen as an academic activity and hence restricted to elite academic institutions . The academic elitism meant doctors from non-elite institutions,other healthcare professionals were excluded and there was poor consideration of actual implementation issues
  • There was inadequate capacity on methods for guideline development and no governance structure in place for the purpose.
  • There were mixed views on involving patients (which is standard internationally since they are the ultimate stakeholders) but in general it was negative.
  • People did not understand what conflict of interest meant and declaring it was seen as a taboo

In terms of policy implications the study implies that a lot of concerted efforts are needed by issuing agencies and the government to ensure development of guidelines in transparent, evidence-based and a systematic manner with high quality in India.

Read the full study here .

Too much medical research may be unnecessary, unethical, unscientific, and wasteful, warns new international research network

Researchers, research funders, regulators, sponsors and publishers of research fail to use earlier research when preparing to start, fund or publish the results of new studies. To embark on research without systematically reviewing evidence of what is already known, particularly when the research involves people or animals, is unethical, unscientific, and wasteful.

To address this problem a group of Norwegian and Danish researchers have initiated an international network, the ‘Evidence-Based Research Network’ (EBRNetwork). The EBRNetwork brings together initial partners from Australia, Canada, Denmark, the Netherlands, Norway, the UK, and USA was established in Bergen, Norway in December 2014. It also has members from low and middle income nations like India, South Africa and Brazil.

At the ‘Bergen meeting’ partners agreed the aim of the EBRNetwork is to reduce waste in research by promoting:

No new studies without prior systematic review of existing evidence

Efficient production, updating and dissemination of systematic reviews

Logo of the new Evidence Based Research Network

My take : In real terms this signifies a tactical shift of the way medical research is conducted and funded globally and bring in more objectivity into funding decisions . The current system of research funding is flawed and decisions are often not on the scientific need of the research to be conducted but on peer-perceptions. It will also prevent policy makers to be mis-guided by scientist who are prone to hype their own agenda for causes of career progression.

Note : The information provided here is adapted from the press release by network together with some personal opinions.  Dr. Soumyadeep Bhaumik is one of the members of the network.

Identifying Research Priorities and Setting Research Agenda in Clinical Toxinology with a Focus on Snake Envenomation

“Identifying Research Priorities and Setting Research Agenda in Clinical Toxinology with a Focus on Snake Envenomation” was the theme of the round table discussion at the Toxinological Society of India Conference 2014 held at Calcutta School of Tropical Medicine on November 22 2014.

Theme lecture on Identifying Research Priorities and Setting Research Agenda was delivered by Dr. Soumyadeep Bhaumik, Cochrane Agenda and Priority Setting Methods Group, & BioMedical Genomics Centre, Kolkata, India

Health Research priority setting processes enable policy-makers, researchers, clinicians and public health professionals to effectively use available resources to collectively decide on what problems or uncertainties are worth trying to resolve/understand for maximal benefit. A transparent and evidence based priority setting process not only helps prioritization but also puts in perspective of patients and the need to improve health outcomes and reverse inequity. Snakebites, a neglected tropical condition, affects millions and kills thousands and yet there is miniscule research in this arena. The presentation focused on the basic concepts of research priority setting exercise, its utility and methods and processes for identifying research gaps and setting research agendas including question formulation, evidence assessment and prioritization process.

The presentation is available here Identifying Research Priorities & Setting Research Agenda. (Click)


The Round Table discussion that followed had the following discussants

1. Professor Y K Gupta (Chair), Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), New Delhi,India
2. Professor Yuri N. Utkin, Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, Russia
3. Professor Chittaranjan Maity, Head of the Department, Department of Biochemistry,KPC Medical College,Kolkata,India
4. Professor Antony Gomes, Laboratory of Toxinology and Experimental Pharmacodynamics, University of Calcutta, Kolkata,India
5. Professor Juan J Calvete, Laboratorio de Venomica , Estrtuctural y Funcional Instituoto de Biomedicina de Valencia, Spain
6. Dr Soumyadeep Bhaumik, Cochrane Agenda and Priority Setting Methods Group, & BioMedical Genomics Centre, Kolkata, India
7. Professor Santanu K Tripathi (Rapporteur for Toxinological Society of India). Head of the Department , Clinical & Experimental Pharmacology, Calcutta School of Tropical Medicine, Kolkata,India

The discussion focused to understand how priority setting processes can be inculcated in the field of snake envenomation and what broad domains can be considered priorities, as well as the ways to deal with challenges to development and implementation of research agenda in snake envenomation .

Please visit :  http://capsmg.cochrane.org/ for more details and resources on setting research agendas and identifying research priorities.

Developing evidence based health policy in resource limited settings—lessons from Nepal

Few would argue against the benefits of evidence informed public health and health policies. However, efforts to inform health policy in resource limited settings face particularly daunting challenges—often specific to the political complexity and resource limitations experienced uniquely in low and middle income countries (LMICs).

The Nepal Health Research Council (NHRC), a Government of Nepal body, has a long held mandate to support informed decision making by health policymakers in Nepal—an exciting but daunting role to operationalise. Informing health policy assumes that there is a base of information to communicate: in Nepal, this often isn’t available.

Read the full article by Dr Sangeeta R, Dr. Soumyadeep B and Dr. Krishna A at the British Medical Journal Blogs (Open Access)

Mapping the growth of The Cochrane Collaboration in India

The Cochrane Collaboration held its annual Colloquium for the first time in South Asia at Hyderabad , India in September 2014. Dr. Soumyadeep B presented a poster to analyse the growth of The Cochrane Collaboration in India. As a vehement supporter of open data the poster is also made available here. The same will also be archived at the 2014 Colloquium Official website. Click on link below or the Image for downloading a pdf of it.

Mapping the growth of The Cochrane Collaboration in India

Regional distribution of Cochrane Contributors in India (Click o Image for Full poster)
Regional distribution of Cochrane Contributors in India (Click on Image for Full poster)

From the #CochraneMethods Symposium of the 22nd Cochrane Colloquium, India

The COCHRANE METHODS SYMPOSIUM 2014 held on Sunday 21st September 2014 at Hyderbad, India was themed “” “From concepts to evidence synthesis:Towards a research agenda for methods of public health systematic reviews ”

Here is a list of some key points, quotes and slides I found interesting :

Liz Waters : Question right and match to the right evidence… Focus on evidence landscaping and realistic and narrative (but transparent) synthesis for public health reviews.

Daniel Francis: Logic Models help multi-disciplinary review teams to come together and explain relationships and improve the entire process, identify intervention components , understand rationale behind subgroup analyses and surrogate outcomes- all in a graphical manner.


James Thomas : Mixed methods meta-analyses allow to empirically understand and explain variations observed- thus allowing contextualization .. Are  complementary to traditional methods.

IMG_0029 IMG_0032

Rebecca Armstrong : Review Advisory groups have an important role and there is need to use them better. Time for Review Advisory Group 2.0 which would include critical friends and stress on web-based technologies and include training as well as link review authors with RAG members .

Ruth Turley : Capturing all relevant evidence with lease amount of noise is difficult in  a public health systematic review. This is complicated by lack of standard terminology, reviews being not restricted to RCT, not indexation of studies and evidence being locked in select databases.


Jane Noyes : New CERQual tool: will become integrated into the summary of findings tables in Cochrane reviewsIMG_0044IMG_0038 IMG_0040 IMG_0042 IMG_0043 IMG_0045 IMG_0046 IMG_0047

Hilary Thomson: Narrative synthesis of quantitative data the Cinderella of Systematic review


Elie Akl: The most positive thing about GRADE us that it is systematic transparent and explicit but there are concerns about choice of outcomes and outcome measurements and the fact that the process is solely dependent on epidemiological data and cannot be applied to narrative synthesis and does not discriminated between different types of observational studies.

IMG_0075 IMG_0073

The Cochrane Colloquium comes to India

Chowmahalla Palace,Hyderabad
Picture from Chowmahalla Palace,Hyderabad, royal seat of the Asaf Jahi dynasty where the Nizams entertained their official guests and royal visitors.

Cochrane, the global leader in evidence-informed health is for the first time in its more than 20 year history (the first Cochrane Centre opened in Oxford,UK in October 1992 ) is for the first time holding its annual colloquium in India, or for that matter in South Asia.

The 22nd Cochrane Colloquium takes place in Hyderabad, India from 21-26 September, 2014 with the theme ‘Evidence-informed public health: opportunities and challenges’. The event is landmark especially when seen in the background of the impending evidence based medicine as well as universal health coverage in South Asia.The event will see Professor Gordon Guyatt delivering the Annual Cochrane Lecture and plenaries conducted and chaired by global leaders on EBM,public health and policies with the following themes :
1. East meets West: Evidence-Informed Public Health; Concepts, Context, Opportunities, Challenges,
2.Public Health: the context, the vision, the opportunities
3.Capacity Development: Challenges and Innovations
4.Cochrane Reviews: Assuring Quality and Relevance
5.Advocating for Evidence: Improving Health Decision-Making through Advocacy, Partnerships and Better Communication

Five Special themed session which will highlight important issues on the following theme are also scnheduled and their are inumerable workshops held.There are about 88 oral presentations and more than hundred posters.

Keep looking at this page for daily on the spot  updates on the event.
Link: https://colloquium.cochrane.org/

Clinical Toxinology and Snake Anti-Venoms in India: Julian White

Research on epidemiology of toxin-based diseases (TBDs) (other than microbial toxin diseases) has long been an area of patchy development, with a few areas undertaking extensive quality research, while many others have fragmentary, unsatisfactory, or virtually non-existent research in this field. This may reflect the reality that TBDs are not a focus for the historic professional groups within medicine, which originated mainly in western communities in Europe, where TBDs are mostly uncommon to rare.

From available research over the last 100 or so years we now know that TBDs are, in fact, an important disease group globally, most notably in the rural tropics and poor communities from the Americas, through Africa, the middle-east and across Asia to the Pacific. Problem TBDs include those caused by both venoms (such as snakebite and scorpion sting) and poisons (such as fugu, ciguatera, and shellfish poisoning).

With climate change, specifically general warming, particularly of oceans, marine poisoning TBDs appear of increasing global importance, especially varieties of shellfish poisoning. These are now affecting developed-world countries such as European nations bordering the Mediterranean Sea. Consequently this group of TBDs is receiving more research attention and so progressively moving out of the “neglected” category.

The rise in development of clinical toxinology as an area of specific medical expertise, over the last 15 years, coincident with the establishment of the international short course in clinical toxinology in 1997 (and still running today), has seen a burgeoning of interest in TBDs and, more particularly, venom-based diseases (VBDs). VBDs such as snakebite have benefitted from the attention of noted researchers and an increasing number of useful epidemiologic and other studies are emerging. For snakebite this has allowed better delineation of the global extent of the problem, resulting in convincing the World Health Organisation (WHO) to devote some resources to this area and declare snakebite a “neglected tropical disease”. WHO has also sponsored development of universal guidelines for antivenom production that should now be used by all antivenom producers to guide their production processes and the expected quality of their products.

It is tragic that India, arguably the nation with the highest toll from VBDs such as snakebite, has historically devoted so little effort to managing these VBDs. The most recent quality epidemiologic research from India indicates in excess of 45,000 Indians die from snakebite every year. The likely number with significant morbidity following snakebite will be far higher. This is an enormous human, social and economic toll on India.

Indian antivenoms (locally and, in my view, inappropriately named “anti snake venom” (ASV)) are available, but of variable quality. More importantly, it appears the Indian health workers are, in general, inadequately trained in the diagnosis and treatment of snakebite and related VBDs. Providing antivenom is not a sufficient response to improving outcomes for snakebite patients. Unless health workers both understand and are prepared to treat snakebite, and are resourced to do so, significant improvements in outcome are unlikely. This requires an ongoing training program. This has been proposed and, on occasion in some locales, actually implemented in recent times, but really requires a whole-of-government commitment and effort and utilisation of actual experts in clinical toxinology to assist in development and deployment of a training system. It is notable that so far, despite invitations, no Indian doctor has attended the Clinical Toxinology Short Course, while a number of doctors from adjacent nations have done so.

It is my understanding, after both reading papers on snakebite from India, and discussing issues with Indian doctors, that antivenom is underused in India because health workers are afraid of treating snakebite and especially afraid of adverse reactions to antivenom. The prime reason for this is inadequate training on the diagnosis and management of snakebite. This needs to be addressed by a national and ongoing training scheme. The secondary reason for reluctance to use antivenom is the quality of the antivenom. Antivenoms made with older standard methods can be associated with high rates of major adverse reactions. Historically Indian antivenoms have been considered as likely to cause major adverse reactions. Modern methods for making antivenoms decrease the likelihood of major adverse reactions to a low rate. It appears that Indian antivenom producers have not accepted these procedures universally.

Snakes are just one type of venomous animal and amongst venomous snakes there are many species and many different venoms and clinical effects. Research into snakebite and antivenom use in another part of the world may not apply to snakebite in India. It is very important that Indian health workers and officials do not take information published by these foreign researchers and assume it applies to India. That is where the expertise of a specialist trained clinical toxinologist is vital, to interpret research and advise on applicability (or not) to India.

Globally there is a wealth of experience with use of antivenom to treat VBDs, particularly snakebite, and most of that experience indicates the positive roll antivenom has in improving patient outcomes. A few, often controversial studies, outside of India, have shown data that antivenom in those particular, non-Indian, circumstances, may not be effective for certain forms of envenoming. Only by undertaking careful research in India, with Indian snakes and antivenoms, in large prospective clinical studies, can we develop knowledge of antivenom effectiveness in the specific Indian setting.

We do already know that Indian antivenoms do not cover all the important venomous snakes and that even for the snakes covered, the methods of production will likely cause deficiencies in coverage. It is essentially to use a venom from geographically diverse sources to make the snake anti-venom effective throughout the nation. Current regulations in India about who can supply snake venom and from where make it difficult or impossible to provide such geographically diverse venom for antivenom production.

These antivenoms almost certainly could be improved further, using new technologies, that may not increase the cost of production. Equally importantly, the coverage of the antivenoms is not ideal and misses some important species such as hump nosed vipers. A better venom immunising mix would allow better coverage for antivenoms, but to obtain this better immunising mix may require changes in government policy about who and how venoms are supplied.

Antivenom can be a very important part of treating snakebite, but it is not the only treatment. A patient with snakebite-induced paralysis may not respond to antivenom, because of the way the venom works. This is not a failure of the antivenom product, but just a reality of venom action. To survive the patient needs external respiratory support and if this is provided effectively, full recovery is likely. Similarly, if venom damages kidneys, temporary support of kidney function is needed and with this most patients should make a full recovery.

It is difficult for a non-Indian doctor to assess how snakebite is rated within the Indian health system. Evidence suggests that, at least in the past, it was an underrated and largely forgotten problem. This may still be the case, but I cannot be sure if changes are already occurring in government policy and action that might change this situation in the future.

The clinicians in this toxinology community, such as myself, remain most interested in assisting India and Indians to develop an effective response to reduce this snakebite toll, but we need to be asked to help by India and Indians, starting at the national government level, but also involving ordinary Indian health workers. It is these health workers who hold the key to improving outcomes for Indian snakebite patients. It is they who ultimately and into the future must deliver care to these patients. We need to empower them to do so effectively and with confidence born from proper training and adequate resourcing. At the same time as improving treatment of bitten patients, every effort should be made to improve prevention, to reduce the number of patients with snakebite.

Prof. Julian White MB, BS, MD, FACTM
Consultant Clinical Toxinologist
Director, Clinical Toxinology Short Course
Head of Toxinology
Women’s & Children’s Hospital
North Adelaide, Australia

Related Links : Clinical Toxinology Resources (http://www.toxinology.com )

Note : This is the full text of an e-mailed interview of Prof White conducted in 2013 .

Polio Free India : a dream realized…

polio13th January 2014 , India : With no case of polio reported since the last three years India is all set to be declared polio today. “The last polio case in India was reported on January 13, 2011 from the state of West Bengal . “

For India once thought to be one of the most difficult nations to achieve polio control (on account of severe resistance to the polio drops from various pockets ) the feat marks a remarkable historical landmark for public health .The dream to have a “Polio Free India” clearly shows the potential of what can be achieved in the public health arena if there is a collective will from public health physicians, clinicians, NGO’s , religious leaders ,the press ,politicians and policy makers.

Being declared polio free officially would mean that any further cases of polio detected would be due to re-infection imported from outside. And this is where the crux of the matter remains. Pakistan and Afghanistan India’s two north-west neighbors continue to report high number of cases . Figure Below

Cases of Polio : GPEI Website

Remaining “Polio-free” will be the biggest challenge for India . Political will and strategies to prevent importing the disease as well as intense continued surveillance for all the time till these nations too achieve polio free status is important. It is easy to loose the momentum and go slack on surveillance once the notion of the goal being achieved set in. .The problems in global polio eradication is as much social , political and cultural as is scientific. The Executive Board of the Global Polio Eradication Initiative is supposed to meet from 20th to 25th January and concrete steps to this direction is something to look forward for India.

Read More about Polio Eradication : Status and Challenges  (Click : Open Access )

Photo Courtesy : http://www.fotopedia.com/items/flickr-4415954257/slideshow

Priority areas for Biomedical Genomics in India : top 3


Genomic medicine is the ‘hot cake’ of current medical research. Here is my take on what should be India’s top priority areas for biomedical genomics research.

1. Research on Ethical issues in biomedical genomics . Biomedical genomic research is associated with various ethical concerns including the issue of identifiable genomic information, informed consent for data sharing of research and intellectual property issues. India has an image of championing the cause of low and middle income nation when it comes to intellectual properties and at the same time when it comes to ethics in clinical trials it has a particularly bad record. This will be one area where India should mark has #1 priority for biomedical genomics research before it ventures into other more adventurous directions . 

2. Research to develop new DNA fingerprinting method for diagnosis of tuberculosis. The ICMR in its priority plan for 2012-2017 has already identified the topic as one of the important areas for research. Considering the public health issue of tuberculosis and the now imminent danger of MDR-TB this is one area India cannot ignore further.

3. Create large phenotype-genotype databases and infrastructure for data sharing
A Center for Public Health and Community Genomics, USA report advocated the need for, “ large population databases to catalog phenotypic-genotypic, demographic, socioeconomic, environmental, and behavioural data in order to explore genetic and external environmental contributions to disease…. Maintaining large databases can potentially allow scientists to examine risk across populations through segmentation, improving an understanding of why some individuals and/or populations develop disease and some remain health.”

India with a huge burden of non-communicable diseases like obesity, diabetes, heart disease, stroke, and cancer will benefit immensely if it takes the lead in this respect if this database is build. It is also important to realise that India is home to “six out of seven genetic variants of the human race “ and without involving research in Indians- genomic medicine can never grow to an adult butterfly with flying colours. India has an immense advantage in the field of information technology so database and infrastructure for data sharing should not be a major problem  .

Image Courtesy :Argonne National Laboratory where it is licensed under the Creative Commons Attribution-Share Alike 2.0 Generic license.