Academic elitism, lack of patient involvement and conflict of interest are stumbling blocks.

Why India needs to overhaul its guideline development process for quality healthcare
Voices Opinion Friday, January 19, 2018 - 16:42

Soumyadeep Bhaumik

India has made rapid strides in providing access to healthcare services since the last decade, but poor quality of care has continued to be a major cause of concern. Irrational use of diagnostic tests, substandard treatment modalities and unnecessary surgeries are far too common. Such unnecessary variations in clinical practice have meant poor health outcomes.

Clinical practice guidelines are increasingly being used to change practice and improve health outcomes globally. A guideline contains recommendations, intended to optimize patient care by promoting beneficial interventions and discouraging harmful ones. These recommendations are “informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options". This means a good quality guideline will not only be informed by a thorough evaluation of research evidence but will also consider resource availability, value judgements regarding benefits and harms, and patient preferences. As such, clinical practice guidelines which have considered all the above and are being monitored for continual improvement, is the bedrock for improving quality of care. But what if all these factors are not considered during the guideline development process? In practical terms, it implies recommendations within an American or European guideline are useless for our purpose.  We need our own guidelines for our own context and this needs to be of good quality.  

In a study we published last week in the Journal of Evidence Based Medicine, we assessed how good the available Indian guidelines were, on ischemic heart disease, lower respiratory infections, chronic obstructive pulmonary disease and tuberculosis. Our team assessed quality of these guidelines by using an internationally validated tool called AGREE-II , which is also recommended by the WHO for monitoring quality of guidelines. We also interviewed guideline developers to understand the development process. 

In general, we found that Indian guidelines were rated poorly. Indian guidelines scored poorly on the domain of stakeholder involvement. Frontline health workers, primary care physicians, programme managers, rural doctors and even patients – people who mattered were seldom involved. Guidelines also inadequately considered factors for barriers and facilitators to implementation, and resource implications and hence scored poorly in the applicability domain. A key issue was guideline development being perceived as an academic exercise and not an implementation issue. This led to a dual impact. On the one hand, it restricted involvement of those from non-elite academic medical institutions leading to poor stakeholder involvement. On the other, it also meant that implementation issues or mechanisms for monitoring guideline implementation were often not considered.  Patients’ involvement was also seen negatively by some guideline developers. 

We found that guidelines were also not based on a systematic appraisal of research evidence and did not follow proper methodologies for formulation of recommendations, leading to poor scores in methodological rigour domain. The good news is people have started to realise that using research evidence to inform the process was key-based, but the lack of in-country capacity and governance for guideline development were significant barriers. 

Many guidelines scored poorly on editorial independence domain in our appraisals because conflicts of interest and an explicit statement describing the funding bodies influence on the content of the guideline, were seldom reported. This was because it was a taboo issue – not to be discussed openly. Transparency in declaration of conflicts of interest and role of funding bodies, is key to gaining public trust, particularly when a lot of discourse on guideline development recently has been around vested interests and pharmaceutical industry influence.

If India as a nation is serious about improving quality of care and wants to regain the trust in medicine, the first step should logically be to develop an evidence-informed contextually relevant guideline, involving all relevant stakeholders. As the results of our study indicate, the current system is broken and we need to overhaul the entire guideline development process. In India, government agencies (central or state) as well as professional associations, make guidelines with little regulatory oversight. The regulatory oversight comes only when complaints for improper standards are filed, making the whole system reactionary rather than proactive. Why not develop good quality clinical practice guidelines in the first place? 

Academic elitism hampers guideline quality in a multitude of ways and these are ingrained within cultural norms. Issuing organizations thus need to consider changing policies to ensure adequate representation of all relevant stakeholders in guideline panels. The rationale of excluding those non-familiar with the guideline development process is not helpful as it only means poor quality. A better approach is making provisions for training and providing support, to enable meaningful participation. Again, enforcing a place in the guideline table might not be enough. It might lead to tokenism. To ensure fair weightage of opinions of all stakeholders’, formal processes for formulating recommendations need to be adopted. Mandatory disclosure of conflicts of interest before participation should be enforced and methods to manage them decided and reported in the interest of transparency. The ICMR is already investing a lot on in-country evidence syntheses capacity but more needs to be done across the country. Existing capacity also needs to be nurtured by involving them in guideline development rather than continuing to develop poor quality guidelines.

The path to Universal Health Coverage is essentially through improving quality of care. The National Health Policy 2017 in fact talks about “active promotion and adoption of standard treatment guidelines” as the starting point for implementation of Clinical Establishment Act and identifies the need to develop such guidelines. Overhauling processes and moving towards international standards of guideline development would require issuing organisations to step outside their comfort zones. The Central TB Division, Government of India has done it recently when they developed the extrapulmonary TB guidelines (it was the only guideline which received good scores on all domains in our study). Would others too?

Soumyadeep Bhaumik is a medical doctor working in the domain of evidence syntheses, program implementation and evaluation. He has provided consultation for the WHO and the ICMR. He was associated with Liverpool School of Tropical Medicine, UK during the time of the study and is currently working in India.

(Views and opinions expressed are the author's own.)

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