RESEARCH EVIDENCE AS THE SINE QUA NON FOR EVIDENCE-BASED MEDICINE (EBM) AS ‘WORK IN PROGRESS’: HOW JUSTIFIED?
Still on the ‘Contextual Conversation’: ‘What is Opinion and what is Evidence?’ [1] which excited a Presentation disposing an ‘Innovative Approach’ to the ‘Practice of Medicine’ and ‘Care of Patients’ ‘Technicalized’ as ‘Multiparameter-based Medicine (MBM)’ [2] ! It is apt and imperative for a rekindling of the ‘Historical Perspectives’ of Evidence-based Medicine (EBM) situate with its ‘Evolution’ as ‘Work In Progress’ coupled with the ‘Operationally Determinant and Defining Premium’ hinged on ‘Research Evidence’!! From the beginning of the ‘EBM Movement’ up until this ‘Critical Conversation’, ‘Research Evidence’ has become the ‘Sine Qua Non’ for any ‘Practice Intervention’ regarded as EBM [3]. The current ‘Situational Reality’ is that ‘Research Evidence’ is ‘Pathognomonic’ of EBM! Can the ‘Determinant and Defining Premium’ invested in ‘Research Evidence’ be justified? This inquisition can be juxtaposed with the ‘Stimulating Question’: ‘What is Opinion and what is Evidence?’ [1].
The ‘Research Evidence’ for this engaging ‘Conversation’ is the ‘Best Available Research Evidence (BARE)’! From the inception of the ‘EBM Movement’ in 1992, the ‘BARE’ was considered as the ‘Sole Determinant’ of the ‘Best Available Patient Care’ expected to be delivered to the Patient situate with ‘Clinical Governance’ [4,5]. With the ‘EBM Movement’, all other hitherto relevant ‘Patient Care Considerations’ were completely vacated: Clinical Intuition, Unsystematic Clinical Experience and Pathophysiological Rationale regarding the Disease [3]. The only ‘Consideration’ that mattered was BARE! Critical appraisal of ‘Patient Care Outcomes’ disposed palpable ‘Unanswered Challenges’ necessitating further review of the ‘EBM Movement Model’. Efforts were made to have a ‘Pyramid of Research Evidence’ disposing the ‘Quality of the Evidence’ in a ‘Structured Hierarchy’ [6]. The ‘Evidence Pyramid’ was constructed to include ‘Clinical Expertise’ albeit disposed at the base as ‘Poor Quality Evidence’! The ‘GRADE Model’ was a further ‘Intervention’ towards resolving ‘Persisting Issues’ in achieving the desired ‘Improved Patient Care’ with the introduction of ‘New Considerations’: ‘Quality of Conduct of Studies’ and ‘Benefits-Harm Balance’ [7]. While the ‘GRADE Model’ is not an ‘Evidence Pyramid’, it is conceptually like the ‘Pyramidal Hierarchy of Evidence’ with ‘Expert Opinion’ considered as ‘Evidence’! The ‘Expert Opinion’/ ‘Clinical Expertise’ is required for appreciating the ‘Guidelines Development’ and for ‘Evidence Interpretation’! Further developments in the ‘EBM Movement’ were aptly disposed in the previous Presentation [2]. Incorporated into the ‘EBM Movement’ from 1996, ‘Patient-related Considerations’ became relevant in ‘Patient Care Matters’ [8]. The ‘Circles of Influence Models’ evolved with the possibility of addressing ‘Persisting Difficulties’ with preceding ‘EBM Movement Models’. The ‘Three Circles of Influence Model’ presented in 1997 included: ‘Research Evidence’, ‘Clinical Expertise’ and ‘Patient Values and Preferences’ [9]. This was modified with another ‘Three Circles of Influence Model’ of ‘Research Evidence’, ‘Patient’s Preferences and Actions’ and ‘Clinical State and Circumstances’ [10] ! The ‘Four Circles of Influence Model’ was revolutionary in disposing the fourth ‘Circle of ‘Clinical Expertise’’ as a ‘Complex Integration’ of the new ‘Three Circles of Influence’!! In the previous Presentation, the ‘Circles of Influence’ were regarded ‘Technically’ as ‘Parameters’ and, therefore, the ‘Four Circles of Influence Model’ was indicated as the ‘Four-Parameter Model’ [2]. In the same Presentation, several ‘Other Parameters’ were identified for inclusion into the ‘EBM Movement Model Metamorphosis’ and the ‘New Model’ was proposed as ‘Multiparameter-based Medicine (MBM)’ [2]!
Back to the focus on ‘Research Evidence’ and the justification for its being the ‘Sine Qua Non’ for EBM/ ‘Multiparameter-based Medicine (MBM)’. The ‘State-of-the Art Research Evidence’ on the ‘Evidence Pyramid’ are the ‘Systematic Reviews and Meta-analyses’ [11,12]. Therefore, the ‘BARE’ for incorporation into MBM is ‘Systematic Reviews and Meta-analyses’. Do these ‘Top-of-the-Bracket Research Evidence’ represent an ‘Excellent or Perfect Entity’? There are a ‘Plethora of Issues/ Difficulties’ with ‘Systematic Reviews and Meta-analyses’ also referred to as ‘Research on Research’! This Presentation will distil some as ‘Tantalizing Teasers’:
1. Formulating the ‘Research Question’ and ‘Research Hypothesis’: These are developed from ‘Background Literature’ and ‘Foreground Literature’ Appraisal respectively but with existent ‘Grey Literature’, these ‘Research Entities’ are unlikely to be ‘Perfect or Excellent’ as the ‘Research Foundation Strength’. The ‘Grey Literature’ represents the ‘Unavailable Literature’: Unpublished Data, Dissertations, Technical Reports, Government Reports and Conference Presentations etc. ‘File Drawer Problem’ is yet another ‘Difficulty’!
2. Generating and Managing ‘Search Terms’ (Keywords and MeSH): With the ‘Boolean Operators’ and ‘Inclusion-Exclusion Criteria’, the ‘Quantity and Quality’ of the ‘Harvested Studies/ Literature’ will be determined.
3. Literature Review/ Appraisal: Using ‘Filtered’ and ‘Unfiltered’ Databases/ ‘Search Engines’ determine how much ‘Critical Reading’ is required in addition to ‘Critiquing Competence/ Skill’.
4. Reporting/ Results Presentations: How ‘PRISMA-compliant’ is the Presentation regarding the 7 of the 27 Items? [13]
5. The ‘Forest Plot’: What are the ‘Evaluated Specifics’ regarding ‘Sensitivity-Heterogeneity-Publication Bias Analyses’? There are several ‘Analytical Tools’ for evaluating these ‘Data Imperfections’: ‘Funnel Plot’, ‘Galbraith Plot’, Egger’s Statistic, Begg’s Statistic, Cochran’s Q, I2, Trim and Fill, Rosenthal’s Fail-Safe N, Orwin’s Fail-Safe N etc [11-13].
6. Significance Issues: Implications of ‘Statistical Significance’ and ‘Clinical Significance’ particularly for ‘Patient Care Decision-making Framework’.
7. Using ‘Individual’ or ‘Aggregate’ Data [14,15]!
It is clear that ‘Systematic Reviews and Meta-analyses (SRMA)’ as the ‘Arrowhead of BARE’ must be subjected to further ‘Critical Scrutiny’ and should not just be harvested and infused into the MBM! In fact, regarding and disposing them as the ‘Sine Qua Non’ for EBM, and indeed, MBM is a significantly flawed ‘Interventional Posture’ [11-15]!
It is pertinent to note that the ‘Parameter’ that is a more ‘Determinant and Defining Factor’ is the ‘Clinical Expertise’/ ‘Expert Opinion’! This ‘Parameter’ is the ‘Ubiquitous Technical Attribute’ for a meaningful and impactful MBM as it is required for:
1. ‘Multiparameter-based Medicine (MBM)’
2. Conducting ‘Clinical Research’ at all levels including ‘SRMA’
3. Conducting Syntheses, Synopses and ‘Meta-Epidemiological Study’ of ‘SRMA’12
4. Conducting ‘Critical Reviews’ of ‘SRMA’
5. Interpreting ‘Research Evidence’ in ‘Guidelines Development and Application’
6. Understanding and Application of ‘BARE-Guidelines Dyad’
7. Avoiding ‘Conflicts of Interest’ in Reporting-Interpreting Reports [16] !
‘Clinical Expertise’-‘Expert Opinion’ represents Professional-Training Exposure/ Formation, Knowledge, Skill-Clinical Acumen-Prowess-Competence, Experience-‘Déjà vu’ and ‘Innate Talent’ and ‘Ability’ to ‘Optimally Harness the MBM Parameters’!! So, ‘Expert Opinion’ animates ‘Research Evidence’ in ‘Optimal Patient Care’ and should be the ‘Sine Qua Non!! A ‘Pyramid of Clinical Expertise’ is an imperative; also ‘Contributory Expertise’ and ‘Interactional Expertise’ exist [17]!
REFERENCES
1. Forsyth S. What is opinion and what is evidence? BMJ 2019; 366:l5395 of 13th September 2019
2. Eregie CO. Beyond Evidence-based Medicine (EBM) as ‘Work In Progress’: An Innovative Proposal for ‘Multiparameter-based Medicine (MBM)’. https://www.bmj.com/content/366/bmj.l5395/rr of 4th October 2019
3. Evidence-based Medicine Working Group Evidence-based Medicine: A new approach to teaching practice of medicine. JAMA 1992; 268 (17):2420-2425
4. Scally G, Donaldson LJ. Clinical governance and the drive for quality improvement in the new NHS in England. BMJ 1998; 317:61-3
5. Campbell S, Sweeney G. The role of clinical governance as a strategy for quality improvement in primary care. Br J Gen Pract2002 Quality Supplement; 52:S12-17
6. Sackett DL, Straus SE, Richardson WS et al. Evidence-based Medicine: how to practice and teach Evidence-based Medicine. 2. Edinburgh: Churchill. Livingstone 1992
7. GRADE Working Group. Grading quality of evidence and strength of recommendations. BMJ 2004; 328 (7454):1490
8. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence-based Medicine: What it is and what it isn’t. BMJ 1996; 312:71-72
9. Sackett DL. Evidence-based Medicine. Seminars Perinatol 1997; 21 (1):3-5
10. Haynes BR, Devereaux PJ, Guyatt GH. Clinical expertise in the era of evidence-based medicine and patient choice. BMJ 2002; 7:36-38
11. Higgins JPT, Green S editors. Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.2 (Updated September 2009). The Cochrane Collaboration; 2009. Available from www.cochrane-handbook.org
12. Haidich AB. Meta-analysis in medical research. Hippokratia 2010; 14 (Suppl 1):29-37
13. Moher D, Liberati A, Tetzlaff J, Altman DG. PRISMA Group Preferred Reporting Items for Systematic Reviews and Meta-analyses: The PRISMA Statement. J Clin Epidemiol 2009; 62:1006-1012
14. Stewart LA, Clarke MJ. Practical methodologies of meta-analyses (Overviews) using updated individual patients’ data. Cochrane Working Group. Stat Med 1995; 14:2057-2079
15. Summonds MC, Higgins JPT, Stewart LA, Tierney JA, Clarke MJ, Thompson SG. Meta-analysis of individual patient data from randomized trials: A review of methods used in practice. Clin Trials 2005; 2:209-217
16. 356:2457-2471Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007;
17. Collins H, Evans R. Rethinking Expertise. New York: University of Chicago Press; 2007
Professor Charles Osayande Eregie,
MBBS, FWACP, FMCPaed, FRCPCH (UK), Cert. ORT (Oxford), MSc (Religious Education),
Professor of Child Health and Neonatology, University of Benin, Benin City, Nigeria,
Consultant Paediatrician and Neonatologist, University of Benin Teaching Hospital, Benin City, Nigeria,
UNICEF-Trained BFHI Master Trainer,
ICDC-Trained in Code Implementation,
*Technical Expert/ Consultant on the FMOH-UNICEF-NAFDAC Code Implementation Project in Nigeria,
*No Competing Interests.
Competing interests:
No competing interests
06 October 2019
CHARLES OSAYANDE EREGIE
MEDICAL DOCTOR
Professor of Child Health and Neonatology, University of Benin and Consultant Paediatrician and Neonatologist, University of Benin Teaching Hospital, Benin City, Nigeria. Also, UNICEF-Trained BFHI Master Trainer and ICDC-Trained in Code Implementaion. Also a Technical Expert/ Consultant on FMOH-UNICEF-NAFDAC Project on Code Implementation in Nigeria
Institute of Child Health, University of Benin, PMB 1154, Benin City, Nigeria
Rapid Response:
RESEARCH EVIDENCE AS THE SINE QUA NON FOR EVIDENCE-BASED MEDICINE (EBM) AS ‘WORK IN PROGRESS’: HOW JUSTIFIED?
Still on the ‘Contextual Conversation’: ‘What is Opinion and what is Evidence?’ [1] which excited a Presentation disposing an ‘Innovative Approach’ to the ‘Practice of Medicine’ and ‘Care of Patients’ ‘Technicalized’ as ‘Multiparameter-based Medicine (MBM)’ [2] ! It is apt and imperative for a rekindling of the ‘Historical Perspectives’ of Evidence-based Medicine (EBM) situate with its ‘Evolution’ as ‘Work In Progress’ coupled with the ‘Operationally Determinant and Defining Premium’ hinged on ‘Research Evidence’!! From the beginning of the ‘EBM Movement’ up until this ‘Critical Conversation’, ‘Research Evidence’ has become the ‘Sine Qua Non’ for any ‘Practice Intervention’ regarded as EBM [3]. The current ‘Situational Reality’ is that ‘Research Evidence’ is ‘Pathognomonic’ of EBM! Can the ‘Determinant and Defining Premium’ invested in ‘Research Evidence’ be justified? This inquisition can be juxtaposed with the ‘Stimulating Question’: ‘What is Opinion and what is Evidence?’ [1].
The ‘Research Evidence’ for this engaging ‘Conversation’ is the ‘Best Available Research Evidence (BARE)’! From the inception of the ‘EBM Movement’ in 1992, the ‘BARE’ was considered as the ‘Sole Determinant’ of the ‘Best Available Patient Care’ expected to be delivered to the Patient situate with ‘Clinical Governance’ [4,5]. With the ‘EBM Movement’, all other hitherto relevant ‘Patient Care Considerations’ were completely vacated: Clinical Intuition, Unsystematic Clinical Experience and Pathophysiological Rationale regarding the Disease [3]. The only ‘Consideration’ that mattered was BARE! Critical appraisal of ‘Patient Care Outcomes’ disposed palpable ‘Unanswered Challenges’ necessitating further review of the ‘EBM Movement Model’. Efforts were made to have a ‘Pyramid of Research Evidence’ disposing the ‘Quality of the Evidence’ in a ‘Structured Hierarchy’ [6]. The ‘Evidence Pyramid’ was constructed to include ‘Clinical Expertise’ albeit disposed at the base as ‘Poor Quality Evidence’! The ‘GRADE Model’ was a further ‘Intervention’ towards resolving ‘Persisting Issues’ in achieving the desired ‘Improved Patient Care’ with the introduction of ‘New Considerations’: ‘Quality of Conduct of Studies’ and ‘Benefits-Harm Balance’ [7]. While the ‘GRADE Model’ is not an ‘Evidence Pyramid’, it is conceptually like the ‘Pyramidal Hierarchy of Evidence’ with ‘Expert Opinion’ considered as ‘Evidence’! The ‘Expert Opinion’/ ‘Clinical Expertise’ is required for appreciating the ‘Guidelines Development’ and for ‘Evidence Interpretation’! Further developments in the ‘EBM Movement’ were aptly disposed in the previous Presentation [2]. Incorporated into the ‘EBM Movement’ from 1996, ‘Patient-related Considerations’ became relevant in ‘Patient Care Matters’ [8]. The ‘Circles of Influence Models’ evolved with the possibility of addressing ‘Persisting Difficulties’ with preceding ‘EBM Movement Models’. The ‘Three Circles of Influence Model’ presented in 1997 included: ‘Research Evidence’, ‘Clinical Expertise’ and ‘Patient Values and Preferences’ [9]. This was modified with another ‘Three Circles of Influence Model’ of ‘Research Evidence’, ‘Patient’s Preferences and Actions’ and ‘Clinical State and Circumstances’ [10] ! The ‘Four Circles of Influence Model’ was revolutionary in disposing the fourth ‘Circle of ‘Clinical Expertise’’ as a ‘Complex Integration’ of the new ‘Three Circles of Influence’!! In the previous Presentation, the ‘Circles of Influence’ were regarded ‘Technically’ as ‘Parameters’ and, therefore, the ‘Four Circles of Influence Model’ was indicated as the ‘Four-Parameter Model’ [2]. In the same Presentation, several ‘Other Parameters’ were identified for inclusion into the ‘EBM Movement Model Metamorphosis’ and the ‘New Model’ was proposed as ‘Multiparameter-based Medicine (MBM)’ [2]!
Back to the focus on ‘Research Evidence’ and the justification for its being the ‘Sine Qua Non’ for EBM/ ‘Multiparameter-based Medicine (MBM)’. The ‘State-of-the Art Research Evidence’ on the ‘Evidence Pyramid’ are the ‘Systematic Reviews and Meta-analyses’ [11,12]. Therefore, the ‘BARE’ for incorporation into MBM is ‘Systematic Reviews and Meta-analyses’. Do these ‘Top-of-the-Bracket Research Evidence’ represent an ‘Excellent or Perfect Entity’? There are a ‘Plethora of Issues/ Difficulties’ with ‘Systematic Reviews and Meta-analyses’ also referred to as ‘Research on Research’! This Presentation will distil some as ‘Tantalizing Teasers’:
1. Formulating the ‘Research Question’ and ‘Research Hypothesis’: These are developed from ‘Background Literature’ and ‘Foreground Literature’ Appraisal respectively but with existent ‘Grey Literature’, these ‘Research Entities’ are unlikely to be ‘Perfect or Excellent’ as the ‘Research Foundation Strength’. The ‘Grey Literature’ represents the ‘Unavailable Literature’: Unpublished Data, Dissertations, Technical Reports, Government Reports and Conference Presentations etc. ‘File Drawer Problem’ is yet another ‘Difficulty’!
2. Generating and Managing ‘Search Terms’ (Keywords and MeSH): With the ‘Boolean Operators’ and ‘Inclusion-Exclusion Criteria’, the ‘Quantity and Quality’ of the ‘Harvested Studies/ Literature’ will be determined.
3. Literature Review/ Appraisal: Using ‘Filtered’ and ‘Unfiltered’ Databases/ ‘Search Engines’ determine how much ‘Critical Reading’ is required in addition to ‘Critiquing Competence/ Skill’.
4. Reporting/ Results Presentations: How ‘PRISMA-compliant’ is the Presentation regarding the 7 of the 27 Items? [13]
5. The ‘Forest Plot’: What are the ‘Evaluated Specifics’ regarding ‘Sensitivity-Heterogeneity-Publication Bias Analyses’? There are several ‘Analytical Tools’ for evaluating these ‘Data Imperfections’: ‘Funnel Plot’, ‘Galbraith Plot’, Egger’s Statistic, Begg’s Statistic, Cochran’s Q, I2, Trim and Fill, Rosenthal’s Fail-Safe N, Orwin’s Fail-Safe N etc [11-13].
6. Significance Issues: Implications of ‘Statistical Significance’ and ‘Clinical Significance’ particularly for ‘Patient Care Decision-making Framework’.
7. Using ‘Individual’ or ‘Aggregate’ Data [14,15]!
It is clear that ‘Systematic Reviews and Meta-analyses (SRMA)’ as the ‘Arrowhead of BARE’ must be subjected to further ‘Critical Scrutiny’ and should not just be harvested and infused into the MBM! In fact, regarding and disposing them as the ‘Sine Qua Non’ for EBM, and indeed, MBM is a significantly flawed ‘Interventional Posture’ [11-15]!
It is pertinent to note that the ‘Parameter’ that is a more ‘Determinant and Defining Factor’ is the ‘Clinical Expertise’/ ‘Expert Opinion’! This ‘Parameter’ is the ‘Ubiquitous Technical Attribute’ for a meaningful and impactful MBM as it is required for:
1. ‘Multiparameter-based Medicine (MBM)’
2. Conducting ‘Clinical Research’ at all levels including ‘SRMA’
3. Conducting Syntheses, Synopses and ‘Meta-Epidemiological Study’ of ‘SRMA’12
4. Conducting ‘Critical Reviews’ of ‘SRMA’
5. Interpreting ‘Research Evidence’ in ‘Guidelines Development and Application’
6. Understanding and Application of ‘BARE-Guidelines Dyad’
7. Avoiding ‘Conflicts of Interest’ in Reporting-Interpreting Reports [16] !
‘Clinical Expertise’-‘Expert Opinion’ represents Professional-Training Exposure/ Formation, Knowledge, Skill-Clinical Acumen-Prowess-Competence, Experience-‘Déjà vu’ and ‘Innate Talent’ and ‘Ability’ to ‘Optimally Harness the MBM Parameters’!! So, ‘Expert Opinion’ animates ‘Research Evidence’ in ‘Optimal Patient Care’ and should be the ‘Sine Qua Non!! A ‘Pyramid of Clinical Expertise’ is an imperative; also ‘Contributory Expertise’ and ‘Interactional Expertise’ exist [17]!
REFERENCES
1. Forsyth S. What is opinion and what is evidence? BMJ 2019; 366:l5395 of 13th September 2019
2. Eregie CO. Beyond Evidence-based Medicine (EBM) as ‘Work In Progress’: An Innovative Proposal for ‘Multiparameter-based Medicine (MBM)’. https://www.bmj.com/content/366/bmj.l5395/rr of 4th October 2019
3. Evidence-based Medicine Working Group Evidence-based Medicine: A new approach to teaching practice of medicine. JAMA 1992; 268 (17):2420-2425
4. Scally G, Donaldson LJ. Clinical governance and the drive for quality improvement in the new NHS in England. BMJ 1998; 317:61-3
5. Campbell S, Sweeney G. The role of clinical governance as a strategy for quality improvement in primary care. Br J Gen Pract2002 Quality Supplement; 52:S12-17
6. Sackett DL, Straus SE, Richardson WS et al. Evidence-based Medicine: how to practice and teach Evidence-based Medicine. 2. Edinburgh: Churchill. Livingstone 1992
7. GRADE Working Group. Grading quality of evidence and strength of recommendations. BMJ 2004; 328 (7454):1490
8. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence-based Medicine: What it is and what it isn’t. BMJ 1996; 312:71-72
9. Sackett DL. Evidence-based Medicine. Seminars Perinatol 1997; 21 (1):3-5
10. Haynes BR, Devereaux PJ, Guyatt GH. Clinical expertise in the era of evidence-based medicine and patient choice. BMJ 2002; 7:36-38
11. Higgins JPT, Green S editors. Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.2 (Updated September 2009). The Cochrane Collaboration; 2009. Available from www.cochrane-handbook.org
12. Haidich AB. Meta-analysis in medical research. Hippokratia 2010; 14 (Suppl 1):29-37
13. Moher D, Liberati A, Tetzlaff J, Altman DG. PRISMA Group Preferred Reporting Items for Systematic Reviews and Meta-analyses: The PRISMA Statement. J Clin Epidemiol 2009; 62:1006-1012
14. Stewart LA, Clarke MJ. Practical methodologies of meta-analyses (Overviews) using updated individual patients’ data. Cochrane Working Group. Stat Med 1995; 14:2057-2079
15. Summonds MC, Higgins JPT, Stewart LA, Tierney JA, Clarke MJ, Thompson SG. Meta-analysis of individual patient data from randomized trials: A review of methods used in practice. Clin Trials 2005; 2:209-217
16. 356:2457-2471Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007;
17. Collins H, Evans R. Rethinking Expertise. New York: University of Chicago Press; 2007
Professor Charles Osayande Eregie,
MBBS, FWACP, FMCPaed, FRCPCH (UK), Cert. ORT (Oxford), MSc (Religious Education),
Professor of Child Health and Neonatology, University of Benin, Benin City, Nigeria,
Consultant Paediatrician and Neonatologist, University of Benin Teaching Hospital, Benin City, Nigeria,
UNICEF-Trained BFHI Master Trainer,
ICDC-Trained in Code Implementation,
*Technical Expert/ Consultant on the FMOH-UNICEF-NAFDAC Code Implementation Project in Nigeria,
*No Competing Interests.
Competing interests: No competing interests