Research Analysis – Dr. Soumyadeep Bhaumik

Maternal Mortality in Afghanistan: a critical review to understand strategic priorities

Afghanistan, a landlocked mountainous nation, situated strategically between Central and South Asia, has been in conflict since the Saur Revolution in 1978 when the socialist People’s Democratic Party (PDP) of Afghanistan seized power from the then secular government (Gascoigne, 2015; BBC, 2015) . This led to a civil war between PDP, supported by the Soviet Union, and the Mujahidin, supported by the United States vide Pakistan. The vicious cycle of conflicts continued till November 2001 when the Taliban (a radical offshoot of Mujahidin) was routed out, ironically by military action of United States(BBC, 2015) .

In 2001, as multi-pronged reconstruction efforts started, it brought hopes that conflict, social upheaval, and food shortages would end(Castillo, 2013), and Afghanistan would march towards the Millennium Development Goals (MDG), along with the 191 other countries that had adopted it . Among the eight ambitious MDG’s , adopted was the goal to “reduce by three-quarters, between 1990 and 2015, the maternal mortality ratio (MMR)”(United Nations, 2015) . Afghanistan however was accorded the unfortunate title of being the “riskiest place on earth for health of mothers” a few years back (Save The Children, 2010) .

The report aims to critically analyse maternal mortality in Afghanistan from the year 2000 to 2015. – a period roughly corresponding to the era of US-led reconstruction action (Castillo, 2013).

The report written for an academic purpose to analyze a post-conflict state is being released publicly on 31^st August 2021 as Afghanistan potentially faces conflict again. The report, it is hoped, serves as a reminder to democratic nations that : Peace is the most important determinant of health. There is no health without human rights.

Maternal Mortality in Afghanistan: a critical review to understand strategic priorities Download

Why the AIIMS/ICMR 2021 COVID guideline is wrong about hydroxychloroquine ?

On 22nd April 2021 in the midst of a crumbling health system the AIIMS/ ICMR-COVID-19 National Task Force/Joint Monitoring Group , Ministry of Health & Family Welfare has finally issued a revised “Clinical Guidance for Management of Adult COVID-19 patients” (* see post-publication note in end). In essence, it is not much of a guideline but a flowchart (much like the previous one). It does not adhering to any standards of a guideline, does not present any evidence (not even citations!), nor does it communicate anything around risk-benefits for any of the drugs. As such, it is impossible to understand how the guideline was developed and why some drugs were chosen and why it was not.

The article however focusses only on one aspect of the guidelines- the recommendation for hydroxychloroquine being recommended as a “may do” . However, this recommendation for hydroxychloroquine is contrary to data from randomized controlled trial. Between July 2020 (when the last guideline was issued) and now, there is a lot of trials that has been completed and we now have reasonable evidence to inform decision making. Evidence from randomized controlled trial shows that hydroxychloroquine does do not have any effect on mortality (based on data from 10859 patients ; 29 studies) in COVID=19 patients . In fact patients given hydroxychloroquine may have significantly more diarrhea , nausea and vomiting compared to those not given so. Diarrhoea and vomiting are known to increase the risk of hypovolaemia, hypotension and acute kidney injury, additional health systems burdens which one should avoided at all costs in this phase of the pandemic.

Hydroxychloroquine for COVID19 clinically meaningful outcomes https://app.magicapp.org/#/guideline/5058/section/67027

Even if we look at health systems relevant outcomes (which are of course equally important to patients) which are of significance in the currently crumbling health system recommending the use of hydroxychloroquine does not make any sense – it increases the number of people who need mechanical ventilation(based on data from 6379 patients ;5 studies).

Hydroxychloroquine for COVID 19 on outcomes of health systems significance https://app.magicapp.org/#/guideline/5058/section/67027

It is high time that issues in the guideline development process that has been already identified are resolved such that lives of patients can be saved through evidence informed therapies .

*As of 10th May 2021 – another version of the AIIMS/ICMR guideline is being circulated in social media without hydroxychloroquine . I could not verify the veracity of this version of guideline being genuine considering the ICMR website https://www.icmr.gov.in/ still hosts the 22nd April 2021 version

Primary closure versus delayed or no closure for traumatic wounds due to mammalian bite

Mammalian bite wounds are a very common clinical problem across the world. Systematic reviews have been conducted to address the role of education in preventing dog bite injuries in adolescents and children (Duperrex 2009) and antibiotic prophylaxis for mammalian bites (Medeiros 2001). However local wound management, one of the most important aspects in management of mammalian bites has not been evaluated by systematic reviews. The issue of primary closure versus delayed closure for non-bite traumatic wounds has been studied previously (Eliya-Masamba 2013), but this systematic review did not include mammalian bites. The issue of primary closure of animal bites remains controversial (Garbutt 2004), and a systematic review in this regard will help to make an objective assessment of this important question, and enable evidence-based clinical decision-making and guideline development.

A Cochrane Review on this is being conducted by Dr. Soumyadeep B and his colleagues. The protocol for the same has been published and is available here (Open Access in India by ICMR grant )

Ethics and equity in research priority-setting: stakeholder engagement and the needs of disadvantaged groups

A transparent and evidence-based priority-setting process promotes the optimal use of resources to improve health outcomes. Decision-makers and funders have begun to increasingly engage representatives of patients and healthcare consumers to ensure that research becomes more relevant. However, disadvantaged groups and their needs may not be integrated into the priority-setting process since they do not have a “political voice” or are unable to organise into interest groups. Equitable priority-setting methods need to balance patient needs, values, experiences with population-level issues and issues related to the health system.
Read the full paper published by Dr. Soumyadeep B et al at Indian Journal of Medical Ethics here (Click: Open Access)

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

B-DaeW5IIAACNiT — 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.

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)

Perspective of different stakeholders in research priority setting for a public health problem in low and middle income nation

The 22nd Cochrane Colloquium in Hyderabad saw a special session on “Setting research agendas: balancing public health and patient level priorities” on 25th September 2014, . The session organised by the Cochrane Agenda and Priority Setting Methods Group (CAPSMG) had the following format :

Session Co-Chairs Roberto D’Amico & Damian Francis

Rebecca Armstrong: Priority setting: the CPHG experience

Robert Dellavalle & Chante Karimkhani :On the Global Burden of Disease project and how it can help set priorities vis-a-vis public health and patient level priorities

Soumyadeep Bhaumik : Perspective of different stakeholders in a research priority setting of a public health problem in LMIC

Kevin Pottie: Priority Setting for Guidelines and Interventions

Vivian Welch: Cochrane Agenda and Priority Setting Methods Group (CAPSMG)

Discussion Session : ROLE PLAY where participants took roles as policy makers, clinicians and members of the public for deciding priority for Ebola and Sin taxes for Sugar Sweetened Beverages.

Dr. Soumyadeep B presentation at the session is attached and free to use under CC-BB-NY-SA (Click)

Perspective of different stakeholders in a research priority setting of a public health problem in LMIC

Visit https://capsmg.cochrane.org/ For more details

Participants in Role Play at the Session

Notes from the GRADE and SoF #CochraneMethods Workshop at #CochraneHYD

Interpreting results of Cochrane reviews and Summary of Findings Tables: GRADE and SoF Workshop Magnitude of effect and confidence on effect are important parameters in quality of evidence

The Cochrane Colloquium 2014 is keeping up with its trend of providing high quality training for doing systematic reviews. The workshop today focused on the very useful issue of interpreting reviews and summary of findings. The event was done by the McMaster University , Canada faculty.

Here are some useful notes from the workshop .

Important parameters assessed in GRADE are
risk of bias
inconsistency
indirectness
imprecision
publication bias
dose response ,
size of effect ,
confounding

The conclusion about the effect of studies should provide the following information.
1.results of section
2.no of studeies
3.magnitude of effect
4.converting it to numbers which stakeholders understand (example : how many fractures were prevented after intervention : use confidence interval to report )
5. GRADE quality of evidence and brief on rational behind it.

New online version of grade software : GDT www.guidelinedevelopment.org

When using scales and reporting in meta-analysis figure or GRADE table it is always important to communicate direction of scale and what is it about.

Remember to adjust for the image scale in forest plot .

Reviewers often forgot the red, green and yellow dots they have created in the risk of bias during interpretation of results .

Funnel plot cannot be created when less than 10 studies
Consider search strategy comprehensiveness, foreign language missing . smaller studies , grey literature search if funnel plot appears skewed.

Also Look at funding of study and competing interests when looking at publication bias .

Look at the characteristics of study carefully when doing GRADE

Do not use terms like ” not statistically significant” .
It is Important to calculate the optimal information size when using GRADE for imprecision. quality

Imprecision is done on basis of following for dichotomous outcomes : 1. sample size and number of events 2, confidence intervals
Imprecision is done on basis of following for Continuos outcomes : at least 400 people providing outcome measures : if not GRADE for imprecision.

Rule of thumb is if CI includes 0.75 to 1.25 indicates null effect and appreciable benefit or harm

Distinction between serious and very serious is important : but the balance is to be done by the reviewers: the thinking behind the judgement should be reflected in the footnotes. Let people know the thinking behind the grade done

small sample size but large effect. : could be indicative of the obeservation being just due to chance. Therefore do not depend on confidence interval but on the number of events.

Their are multiple ways of choosing a baseline risk for GRADE process. It can be the average or the extremes or even baseline risk from observational study. However this has to be justified.

All presentations in the colloquium are available at http://cebgrade.mcmaster.ca/hyderabad/.

What are the benefits and harms of different intravenous fluid regimens in people with acute bacterial meningitis?

Along with Dr Ian K Maconochie Department of Paediatrics A&E, St Mary’s Hospital, London, UK – Dr Soumyadeep Bhaumik has completed a Cochrane systematic review and meta-analysis titled “Fluid therapy for acute bacterial meningites”.

The extensive review has data of 415 patients in total and “no significant differences in death rates or overall effects on neurological function, either immediately or later. There was also some evidence favouring maintenance fluid therapy over restricted fluids for chronic severe neurological events at three months follow-up.”

However the available evidence is limited and not of high quality (GRADE) and there is an immense need to conduct more research on the issue . It is indeed sad that trials on intravenous fluids for bacterial meningites,one of the most importance interventions are not happening. This is probably because unlike antibiotics from which “big and small pharma “can make huge profites – research on intravenous fluids is not profitable. There is a need for charities as well as government funding for sponsorinf trials on these kind of interventions.

Read full Cochrane Review here . (Click : Open access in India vide ICMR funding)

Read Cochrane Clinical Answer on this topic here . (Click : needs subscription)

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this:

Share this:

Like this: