The use of guidelines development standards in recommendations and guidelines for retinopathy of prematurity
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Authors
Objective: Our publication aimed to identify and present standards and
tools implemented in the development of guidelines for retinopathy of
prematurity (ROP).
Methods: The results were based on complementary data extraction from
records identified in the systematic review of the guidelines for retinopathy
of prematurity performed in 2022. We examined the type of evidence used to
develop the guidelines, the standards followed by authors in developing
guidelines, and the system for classifying scientific evidence quality. The identified
standards for guideline development were checked for validity and the
methodology for assessing scientific evidence and presenting recommendations was
described.
Results: Our analysis of twenty-three retinopathy of prematurity
guidelines uncovered two standards: World Health Organization Handbook and Setting
Standards for the Development of Clinical Guidelines in Paediatrics and Child
Health by Royal College of Paediatrics and Child Health (RCPCH). Only two
guidelines from India and Latin America followed the WHO handbook and applied the
GRADE system for assessing the quality of evidence and recommendations, while
the United Kingdom guidelines adhered to the RCPCH standard and SIGN Grading
Hierarchy.
Conclusion: Our analysis revealed the need for improvement in the
process of creating guidelines for retinopathy of prematurity in most
countries. We believe that by raising awareness about the tools
available to support authors we are able to spread their use as a standard
practice.
Introduction
The clinical practice guidelines are documents that aim to help
practitioners make decisions in the therapeutic process. It is essential to
present evidence-based data transparently and in a systematised way. Guideline
development is a sustained and challenging process therefore obtaining valuable
data requires a precise approach to the issue.
Many tools and qualification systems, such as GRADE (Grading of
Recommendations, Assessment, Development, and Evaluations) include a
methodology on how to formulate guidelines to ensure that presented data are of
high quality. [1] GRADE is the widely adopted tool for grading the
quality of evidence and provides a clear and structured methodology for
developing and presenting evidence summaries. Due to its comprehensiveness and
transparency, it was adopted in numerous countries. Many organisations and
societies such as World Health Organisation (WHO) [2], and National Institute for Health and Clinical
Excellence [3] base their guidelines on the GRADE methodology. Unfortunately,
not all guidelines include the GRADE approach. This was demonstrated by
research, which revealed that among 240 Australian practice guidelines only fifteen
embraced GRADE for assessing evidence. [4]
The aim of our publication was to define what tools were implemented in
the development of guidelines for retinopathy of prematurity (ROP) and with
what frequency they were used globally.
Methods
The results are based on complementary data extraction from records identified
in the systematic review of the guidelines for retinopathy of prematurity that
was performed in 2022. [5] Search strategy, inclusion, and exclusion criteria have
been described in the systematic review.
Data extraction included: 1. the type of evidence on which guidelines
were developed, 2. standards followed by authors during the process of
guideline development, and 3. a system for classifying scientific evidence
quality.
The identified standards for guideline development were checked for
validity on the publishers' websites. The methodology of assessing the quality
of scientific evidence and presenting the strength of recommendations in these
standards was described. Previous versions of standards were excluded.
Results
Our analysis of twenty-three retinopathy of prematurity guidelines
revealed that two standards were used during the guideline development process:
1. WHO Handbook for Guideline Development [2] and 2. Standards for Development of Clinical Guidelines
in Paediatrics and Child Health by Royal College of Paediatrics and Child
Health (RCPCH) [6]. When verifying the validity of these two standards,
an updated version of the RCPCH standards for the development of guidelines was
found, included in the review, and discussed later. [7]
Only guidelines from India and Latin America adhered to the WHO handbook, while the United Kingdom followed the standards set by the RCPCH. These findings are presented in Table 1 and demonstrate significant variations in guideline adoption strategies among countries. Two guidelines implementing WHO handbook applied the GRADE system for data classification, and the guidelines from the United Kingdom applied the Scottish Intercollegiate Guidelines Network (SIGN) grading hierarchy, [8] indicating a standardised approach to evidence evaluation. In contrast, other countries employed diverse methodologies such as literature reviews, expert consensus, or the use of national data without a standardised classification system.
Table 1.
Characteristics of the retrieved guidelines and recommendations. [5]
Country |
Author,
reference |
Year |
Title |
Standard
followed |
Classification
system |
Canada |
Jefferies
et al. [9] |
2016 |
Retinopathy
of prematurity: An update on screening and management |
- |
- |
Czech
Republic |
Zobanová
et al. [10] |
2018 |
Screening,
treatment and long-term observation of retinopathy of prematurely born
children in the Czech Republic |
- |
- |
Egypt |
United
States Agency for International Development et al. [11] |
2010 |
Neonatal
Care Protocol for Hospital Physicians |
- |
- |
India |
Chandra et
al. [12] |
2020 |
Screening
and Management of Retinopathy of Prematurity |
WHO |
GRADE |
India |
Ministry
of Health & Family Welfare India [13] |
2017 |
Guidelines
for Universal Eye Screening in Newborns Including Retinopathy of Prematurity |
- |
- |
India |
Public
Health Foundation of India et al. [14] |
2018 |
Project
Operational Guidelines. Prevention of Blindness from Retinopathy of Prematurity
in Neonatal Care Units |
- |
- |
Indonesia |
Siswanto
et al. [15] |
2020 |
How to
prevent ROP in preterm infants in Indonesia? |
- |
- |
Kenya |
Ministry
of Health Kenya [16] |
2018 |
National
guidelines for the Screening and Management of Retinopathy
of Prematurity in Kenya |
- |
- |
Latin
America |
International
Agency for the Prevention of Blindness - Latin America [17] |
2010 |
Guidelines
for ROP Screening and Treatment in Latin American Countries |
- |
- |
Latin
America |
Pan
American Health Organization [18] |
2019 |
Clinical
Practice Guidelines for the Management of Retinopathy of Prematurity.
Summarised Version 2017 |
WHO |
GRADE |
Malaysia |
Ministry
of Health Malaysia et al. [19] |
2005 |
Clinical
Practice Guidelines. Retinopathy of Prematurity |
- |
- |
New
Zealand |
Newborn
Clinical Network et al. [20] |
2017 |
Consensus statement
for Screening for Retinopathy of Prematurity |
- |
- |
Philippines |
Philippine
Academy of Ophthalmology et al. [21] |
2013 |
Recommended
Philippine Guidelines for Screening and Referral of Retinopathy of
Prematurity |
- |
- |
Philippines |
Philippine
Pediatric Society et al. [22] |
2020 |
Retinopathy
of Prematurity Philippine Preventive Care Plan Strategy |
- |
- |
Poland |
Gotz-Więckowska
et al. [23] |
2020 |
Polish
Ophthalmological Society revised guidelines for the management
of retinopathy of prematurity |
- |
- |
Saudi
Arabia |
Al Amro et
al. [24] |
2018 |
Practical
guidelines for screening and treatment of retinopathy of prematurity in
Saudi Arabia |
- |
- |
Slovakia |
Prepiaková
et al. [25] |
2014 |
Screening
of Retinopathy of Prematurity (ROP) |
- |
- |
South
Africa |
Visser et
al. [26] |
2013 |
Guideline
for the prevention, screening and treatment of retinopathy
of prematurity (ROP) |
- |
- |
Spain |
Ferrer
Novella et al. [27] |
2013 |
Screening
program for retinopathy of prematurity in Spain |
- |
- |
Sri Lanka |
College of
Ophthalmologists of Sri Lanka et al. [28] |
2019 |
National
Guidelines for Screening for Retinopathy of Prematurity |
- |
- |
Turkey |
Koç et al. [29] |
2018 |
Turkish
Neonatal and Turkish Ophthalmology Societies consensus guideline on the
retinopathy of prematurity |
- |
- |
United
Kingdom |
Royal
College of Paediatrics and Child Health et al. [30] |
2008 |
Guideline
for the Screening and Treatment of Retinopathy of Prematurity |
RCPCH [6] |
SIGN |
United
States of America |
Fierson et
al. [31] |
2018 |
Screening
Examination of Premature Infants for Retinopathy of Prematurity |
|
|
GRADE = Grading of Recommendations, Assessment, Development, and Evaluation, RCPCH = Royal College of Paediatrics and Child Health, SIGN = Scottish Intercollegiate Guidelines Network, WHO = World Health Organization. |
Discussion
The use of an appropriate
methodology that takes into account the GRADE tool, provides high-reliability recommendations
and increases the chance of positive assessment using guideline evaluation
tools. [32]. For this reason,
organisations such as WHO and RCPCH in their new standards [7] both recommend the
GRADE methodology for guideline development. Unfortunately, many authors do not
conduct a systematic approach to the process of creating guidelines and the
quality of including data remains often unsatisfactory. [4, 5] Using non-systematic
methods compromises the validity and reliability of recommendations, leading to
potentially untrustworthy results.
WHO actively incorporates the GRADE methodology into its guideline
development process. The GRADE methodology serves as a systematic and
transparent approach used in the WHO handbook to assess the quality of
evidence. When creating guidelines, WHO applies the GRADE methodology to
varying extents, depending on factors such as the nature of the guideline and
the available evidence. [33, 34]
During the development of guidelines, the WHO handbook recommends a
comprehensive assessment of each relevant research. This assessment includes
evaluating the study design, examining the potential risks of bias, ensuring
consistency of findings across multiple studies, assessing the precision of the
reported results, and considering the possibility of publication bias. In this
process, WHO conducts systematic reviews of available studies that investigate
various treatment approaches. The design of each study is critically evaluated
to determine its reliability and potential sources of bias. This evaluation
process allows WHO to ensure the use of high-quality evidence and minimizes the
risk of drawing incorrect conclusions. Based on the accumulated evidence, WHO recommends
assigning a GRADE rating to each body of evidence. This rating indicates the
level of confidence in the estimated effect derived from the analysed evidence.
The GRADE rating system classifies the evidence as high, moderate, low, or very
low, providing transparency about the strength of the recommendations. The
incorporation of the GRADE methodology helps to thoughtfully examine both the benefits
and potential limitations of interventions. By considering all of these factors
of guideline development, WHO aims to publish guidelines that are of high quality,
evidence-based, and clinically useful. [2]
Setting Standards for the Development of Clinical Guidelines in
Paediatrics and Child Health provides
the newest summary of the RCPCH standards for guideline development within the
United Kingdom. RCPCH aims to improve and diminish inequalities in clinical
practice in paediatrics by ensuring that guidelines are based on the proper evidence. [7]
RCPCH incorporates National Institute for Health and Care Excellence
(NICE) methodology [3] into its standards. When creating guidelines, the NICE
key principles are followed: 1. ensuring that guidance is based on the best
evidence of effectiveness and cost, 2. involving independent committees of
experts, 3. including at least two lay members, 4. conducting consultations to allow
stakeholders to comment on the recommendations, 5. reviewing and updating published
guidelines if necessary, 6. ensuring the processes, methods and policies
necessary for guideline development remain up‑to‑date.
RCPCH Guideline Development Group (GDG) collaborate with stakeholders to
ensure the usefulness of guidelines in daily clinical practice. RCPCH conducts an
assessment of collected data and each relevant publication is evaluated with
respect to its methodology and reliability. Since 2013 the GRADE approach has
been recommended to assess the quality of evidence, replacing the earlier
system used in the SIGN methodology. [7] The previous was based on grades of recommendations
(A-D, Good Practice Point), the assignment of which depended on the strength of
the evidence and the possibility of extrapolating the results to the target
population. Good Practice Points grades were based on the clinical experience and
consensus of the GDG. [8]
Incorporation of GRADE methodology enables the comparison of collected
data on many levels, including internal validity, inconsistency, indirectness, imprecision,
or publication bias. RCPCH emphasises the significance of GRADE methodology due
to its comprehensiveness and transparency. However, this approach may be more demanding
and pose difficulties for small organisations, which collaborate with RCPCH.
For this reason, RCPCH also considers utilising a non-GRADE approach. [7]
Although GRADE tool is an
excellent standard for guideline development, only three [12, 18, 30] from twenty-three
guidelines in this review used GRADE. This review indicates significant
variations in the strategies used to collect and present data on ROP across different
countries. While some authors rely on rigorous literature reviews, others base
their guidelines on national or international data without any standardised methodology.
Understanding the reasons behind these differences and identifying country-specific
limitations is crucial for harmonising global guideline development processes.
Conclusions
Determining the quality of the evidence and the strength of the recommendations is essential to present evidence-based data transparently, enabling their easy use in clinical practice. Our analysis revealed the need for significant improvement in the process of creating guidelines for retinopathy of prematurity in most countries. We hope that raising awareness about the tools available to support authors will help spread their use as a standard practice.
Conflict of interest
The authors declared no potential conflict of interest.
Funding
The authors received no financial support for the research, authorship, and/or publication of this article.
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