Evidence-based practice is based on critical assessment of the scientific evidence surrounding a particular medical product which can come from sources such as well-designed randomized clinical trials, cohort studies, observational studies, retrospective data reviews, etc. Such evidence allows us to evaluate the actual effect of a medical product on patient outcomes, but can vary in quality. In contrast, consensus guidelines issued by professional organizations typically represent a consensus or agreement among experts with regard to a certain approach to diagnose or treat a particular disease or condition.
Applying evidence to clinical practice is a requirement for best patient care. The concept of “Evidence-based medicine” implies that although evidence can recommend particular diagnostic strategies, treatments or management plans, each plan must be individualized to reflect the specific characteristics of individual clinical circumstances. Government and third-party payers are increasingly using evidence summaries to guide reimbursement decisions—interventions with good quality evidence are thus more likely to be supported by payers than interventions lacking such evidence.
Many healthcare organizations are also promoting the development of computerized clinical decision support systems (CCDSS) with the aim of improving healthcare efficiency. The claim is that CCDSSs match the characteristics of patients to a computerized medical knowledge base and provide recommendations to clinicians to help with the accuracy and consistency of clinical decisions and thereby improve the care and the outcomes of patients.
Consensus guidelines have increasingly become an integral part of evidence-based medicine not only in individual and institutional clinical practices, but also with governments and payers. Consensus guidelines are healthcare recommendations that are provided by a body of experts who conduct a systematic review of data on how to treat or diagnose a disease with the aim of better patient outcomes. These guidelines provide evidence to:
a) Serve as a framework for informed clinical decisions intended to improve patient outcomes
b) Help incorporate best available evidence into clinical practice – a tool to close the gap between the current standard-of-care and what evidence supports
c) Reduce variations, prevent errors and increase clinicians’ accountability in the healthcare practices
d) Reduce per capita healthcare costs and improve resource utilization
e) Focus on quality control
f) Help researchers identify gaps in the evidence and what key research questions have yet to be answered.
How Consensus Guidelines Help Standardize Practices and Improve Interventions
The focus on standardizing healthcare practices should be to deliver consistent, cost-effective, quality healthcare. With the ever increasing range of healthcare products and services, evidence-based guidelines can help deliver effective, safe and affordable solutions which are acceptable to patients, caregivers and also the payers. These solutions can encompass the entire spectrum of healthcare management: prevention, screening, investigations, diagnosis, and treatment. Below are a few examples of how consensus guidelines have helped to improve interventions and prioritize those with the greatest value.
- In Canada, a guideline demonstrated that a new treatment for patients with atrial fibrillation, although more expensive than the standard-of-care, not only improved clinical outcomes but was also proven to be more cost-effective when use of public health resources was considered.1
- In breast-conserving surgery, guidelines have been established that define the minimal acceptable tissue margin width, simplifying the decisions regarding re-excision, and considerably augmenting consistency and quality of breast cancer care.2
- Economic evaluation of healthcare interventions, although uncommon, is being carried out even in developing countries like India. The government and Clinical Epidemiology Resource and Training Centre (CERTC) of a state in India (Kerala) have formalized the development, dissemination, and implementation of consensus guidelines for selected high-priority diseases. Acknowledging the disparity in the quality of primary and secondary healthcare between urban and rural settings, they aim to publish minimum quality healthcare standards in Kerala.1
The What and How of Consensus Guidelines
In addition to consensus guidelines almost all major clinical organizations around the world have published Clinical Practice Guidelines (CPGs). In the UK, the National Institute of Clinical Excellence (NICE) and the Royal medical college regularly publish Clinical guidelines. AHRQ’s (Agency for Healthcare Research and Quality) National Guideline Clearinghouse, an initiative of the U.S. Department of Health and Human Services, is a public repository for summaries of hundreds of evidence-based CPGs. When there are several such guidelines available, how does one decide the quality and the strength of evidence that forms the basis of these guidelines? The updated AGREE (The Appraisal of Guidelines for Research and Evaluation) checklist from 2013 includes 6 quality domains including scope and purpose, stakeholder involvement, and rigour of development.3 The 23 key items organized in the quality domains provide a systematic and logical process for reporting essential information about the CPG and help assess their quality. The Cochrane Effective Practice and Organization of Care Group also undertakes systematic reviews of professional, organizational, financial and regulatory interventions.
The consensus guidelines are developed by expert panels that comprise individuals largely external to the national body or society developing the guidelines. Once the topic is approved, the process involves:
1. Inviting panel members and development of protocol worksheet with research questions (scope and objectives)
2. Appointing a writer as well as a chair, who serves as an expert facilitator
3. Systematic literature review and meta-analysis
4. Formulating guideline recommendations based on decision points and participants’ discussion (steering committee, Subject Matter Experts, Key Opinion Leaders, non-physicians and medical writer)
5. Drafting consensus recommendations and clinical considerations based on rating
6. Defining consensus—strong consensus, consensus and no consensus
7. Appraising quality, and strength of evidence and recommendations
8. Publication—dissemination and applicability to a larger audience
Roadblocks in Consensus Guideline Development and Local Relevance
In real world settings, however, there are several challenges in Consensus Guideline development and dissemination. Some of the challenges include:
a) Methodology and development: dearth of a sound evidence base, lack of trustworthy methodology and transparency, conflict of interest of development groups’ methodologies and a lack of rationale for deviations from existing guidelines.
b) Biased approach: Industry sponsored guidelines are often under suspicion of potential bias.
c) Disease and healthcare variability: Guidelines developed by European or American bodies may not be applicable to the standard of care in the African or the Asia Pacific regions. Most importantly, disease burden and access to treatment may vary. The key ‘barriers’ towards improving outcomes in these regions include patient education and the widespread adoption of cost-based healthcare systems. So the consensus statements need to assess initiatives to overcome these barriers for better implementation of pre-hospital management strategies, greater community outreach with patient/physician education and telemedicine, and sustainable economic models to improve accessibility to effective pharmacotherapies.
d) Cultural differences: The applicability of guidelines may be further reduced in developing countries not only due to lack of awareness and professional acceptance, but also due to want of resources and absence of a formal Health Technology Assessment (HTA) program. Hence involvement of experienced local key opinion leaders who are conversant with standard clinical practices and availability of therapeutic modalities with their outcomes becomes pertinent in developing feasible guidelines.
In order to overcome the roadblocks noted above, an external Medical Affairs (MA) partner can become instrumental in developing, publishing and perpetuating Consensus Guidelines for pharmaceutical sponsors as well as for professional national level bodies. As an independent entity, the MA service provider can:
a) Ensure minimal conflict in the composition of the working group and the guideline proceedings along with commitment to timelines by all stakeholders
b) Liaise with the local medical experts and provide a platform to discuss the applicability of international CPGs to their region
c) Facilitate the development of locally relevant guidelines by encouraging interaction and comments from the practitioners
d) Update the guideline based on the availability of upcoming evidence and opinions expressed by the practioners on the current recommendations
e) Collate recommendations and choose the right journal for publication
f) Ensure that health care providers get easy access to evidence-based, appropriate and practicable healthcare solutions
To conclude, with the evolution of better patient management strategies, newer disease knowledge and novel therapies, clinical practice must be updated with current clinically relevant information to improve patient care. And the best way to do this is to formulate standard consensus guidelines based on research evidence.
1. Hass B, Pooley J, Feuring M, Suvarna V, Harrington AE. Health technology assessment and its role in the future development of the Indian healthcare sector. Perspectives in Clinical Research. 2012;3(2):66-72. doi:10.4103/2229-3485.96449.
2. Michael S, Reshma Jagsi. The Potential Benefits of Consensus Guidelines for Breast-Conserving Surgery. MAY 25, 2017
3. Brouwers M, Kho ME, Browman GP, Cluzeau F, Feder G, Fervers B, Hanna S, Makarski J on behalf of the AGREE Next Steps Consortium. AGREE II: Advancing guideline development, reporting and evaluation in healthcare. Can Med Assoc J. Dec 2010, 182:E839-842; doi: 10.1503/cmaj.090449