Comparison of recommendations from cirrhosis Clinical Practice Guidelines and from Cochrane systematic reviews

doi:10.21203/rs.3.rs-2194398/v1

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Comparison of recommendations from cirrhosis Clinical Practice Guidelines and from Cochrane systematic reviews

https://doi.org/10.21203/rs.3.rs-2194398/v1

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Background: Clinical practice guidelines (CPGs) contain recommendations intended to aid clinicians in providing optimal care for patients and should be derived from the best quality evidence available. The highest quality evidence is obtained through systematic reviews using Cochrane methodology. This exploratory study aimed to determine the proportion of guideline statements from major liver organisations in USA and Europe that were consistent with the conclusions of recent systematic reviews using Cochrane methodology.

Methods: We selected four topics related to decompensated cirrhosis on which our group has recently published Cochrane systematic reviews (variceal bleeding; spontaneous bacterial peritonitis; ascites; hepatorenal syndrome). We performed a purposive sample of CPGs from leading organisations covering these topics: American Association for the Study of Liver Diseases (AASLD); British Society of Gastroenterology (BSG); European Association for the Study of the Liver (EASL); and National Institute for Health and Care Excellence (NICE) until January 2022. For each guideline recommendation statement, two researchers independently assessed whether there was agreement in the statement and the strength of recommendation given by guideline authors when compared to those derived from the Cochrane reviews. We meta-analysed the proportion of agreement using ‘meta’ package for R utilising the ‘Generalised Linear Mixed Model’ method for meta-analysis of proportions.

Results: We identified 9 CPGs containing 62 guideline statements that were also covered in 7 Cochrane reviews. Agreement between the guideline authors and independent assessment was 0.145 (95% CI: 0.077 to 0.256), i.e., there was disagreement in 85.5% of recommendation statements. There was disagreement on four of the 62 guideline statements about the use or consideration of an intervention when there was no evidence to support their use or consideration. The remaining disagreements related to the disagreement in the strength of recommendation: in each of these disagreements, the guideline author had provided a strong recommendation for or against an intervention when there was only weak evidence for or against the intervention. For each disagreement in the strength of recommendation, the strength of recommendation was overstated rather than understated by the guideline authors. The disagreement could not be explained by the difference in the search dates between the guidelines and Cochrane reviews.

Conclusion: The strength of recommendation given in the majority of CPGs from leading liver organisations on decompensated liver cirrhosis did not match those derived from Cochrane reviews. Our findings suggest a systematic issue with guideline developers overstating the strength of recommendations, which has the potential for direct impact on patient care.

Health sciences/Gastroenterology/Hepatology/Liver diseases/Liver cirrhosis

Health sciences/Health care/Therapeutics

Health sciences/Diseases/Gastrointestinal diseases/Liver diseases/Liver cirrhosis

Health sciences/Medical research

Practice guideline

Bias

Liver cirrhosis

Spin

Shared decision making

Clinical practice guidelines contain recommendations intended to aid clinicians in providing optimal care for patients. These should be derived from the best quality evidence available, often considered to be provided by Cochrane systematic reviews. This study aimed to explore the reliability of guidelines from major liver organisations by assessing the proportion of guideline statements that were consistent with the conclusions of recent systematic reviews using Cochrane methodology. We identified 9 clinical practice guidelines on advanced liver disease from 4 major organisations (American Association for the Study of Liver Diseases, British Society of Gastroenterology, European Association for the Study of the Liver, and National Institute for Health and Care Excellence), containing 62 guideline statements that were also covered in 7 Cochrane reviews. Here we show that the strength of recommendation given in the majority of clinical practice guidelines from leading liver organisations on advanced liver disease did not match those derived from Cochrane reviews. We found that there was disagreement between the guideline authors and independent assessment in 85.5% of recommendation statements. Our findings suggest a systematic issue with guideline developers consistently overstating the strength of recommendations, which has the potential for direct impact on shared decision-making and patient care. We anticipate that our findings will lead to future work on improving methodology for developing reliable clinical practice guidelines.

It is widely accepted, that systematic reviews of randomised clinical trials sit at the top of the hierarchy of evidence pyramid; aiming to provide the best possible evidence on a given topic^1,2. Within the field of critical appraisal and evidence synthesis, Cochrane reviews have been long considered the gold standard; synonymous with the highest quality systematic reviews which should be robust against bias, due to the standardised, rigorous methodology; careful, precise application of the quality standards; and regular updates to reflect the findings of new evidence when it becomes available³. However, busy practicing clinicians will not have the time to regularly read and consider the evidence contained within such systematic reviews as it pertains to the patient in front of them⁴. Therefore, clinical practice guidelines (CPGs) were introduced to provide a synthesis of the healthcare information for practising clinicians. CPGs are commonplace and often considered incredibly useful: research groups scrutinise all the evidence available on a particular subject and then provide recommendations to guide healthcare professionals in their day-to-day clinical practice⁵. The updated definition by the Institute of Medicine (IOM) from 2011 specifies CPGs as ‘statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options’⁶. IOM also states that systematic reviews should underpin clinical practice guidelines⁷.

We have performed several Cochrane systematic reviews and meta-analyses within the clinical area of liver cirrhosis and related topics of ascites, variceal bleeding, spontaneous bacterial peritonitis (SBP), and hepatorenal syndrome^8-14. The list of Cochrane reviews, the search dates at the time of publication of the Cochrane reviews, and our conclusions from these reviews are available in Extended Data Table 1. While preparing these systematic reviews, we noted that there were some discrepancies between the evidence and guideline statements from leading associations that formulate clinical practice guidelines on decompensated cirrhosis. This observation is in accordance with several studies pointing at discordances between strength of recommendations and evidence supporting the recommendation^15,16. The aim of the present exploratory study is to determine the proportion of guideline statements from major liver organisations in USA and Europe that reflect the conclusions from systematic reviews of treatment performed using the high standard of Cochrane methodology.

Guideline selection

In this pilot scoping study, we selected all our recent Cochrane systematic reviews related to advanced liver cirrhosis and its sequelae, published during the past three years ^8-14. We then performed a purposive sample of widely used liver clinical practice guidelines published by: The American Association for the Study of Liver Diseases (AASLD; https://www.aasld.org/), The British Society of Gastroenterology (BSG; https://www.bsg.org.uk/), The European Association for the Study of the Liver (EASL; https://easl.eu/), and The National Institute for Health and Care Excellence (NICE; https://www.nice.org.uk/guidance/). For each of these organisations, we searched from inception to search date (18 January 2022) using search terms ‘cirrhosis’ and ‘varices’ (as independent terms) to identify CPGs related to decompensated cirrhosis. We then selected the most recent guidelines covering the treatment of ascites, variceal bleeding, spontaneous bacterial peritonitis, and hepatorenal syndrome as these were the issues covered by the recent Cochrane reviews.

Data collection and processing

Two researchers independently and systematically reviewed each guideline statement in the qualifying guidelines, to extract information on specific recommendations made and the strength of recommendation.

When the strength of recommendation was not available directly from the guidelines, we assigned a strength of recommendation based on the strength of wording used in the guidance statements based on guidance from The Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group on appropriate wording for strong and weak recommendations ¹⁷. For example, words such as ‘should’ or ‘must’ were considered to indicate strong recommendation and words such as ‘consider’ or ‘may’ were considered to indicate weak recommendation.

We converted the treatment effects identified in the Cochrane reviews and the certainty of evidence in the Cochrane reviews to strength of recommendation using the GRADE methodology for determining the strength of recommendation, i.e. according to four factors: (i) balance between desirable and undesirable effects; (ii) certainty of evidence; (iii) patient values and preferences; (iv) costs or resources utilised (cost-effectiveness) ¹⁸.

We then compared the recommendations of the guideline statements (specific treatment recommendations and the strength of recommendation) by leading associations to those derived from the Cochrane reviews. GCP recommendation statements that were not covered within the inclusion criteria for the corresponding Cochrane review were excluded. For example, statements related to ‘suspected’ rather than ‘confirmed’ variceal bleeding, or recommendations on second line therapies (rescue/refractory treatments) when the first line therapies for variceal bleeding did not work were excluded, as these patient groups were excluded from the Cochrane review on the treatment for bleeding oesophageal varices. Differences were resolved through discussion.

Analysis

For each selected CPG statement, we assessed the agreement to the statement and the strength of recommendation according to clinical practice guideline authors to those that we developed from the findings of the Cochrane reviews. We meta-analysed the proportion of agreement using ‘meta’ package for R ¹⁹ utilising the ‘Generalised Linear Mixed Model’ method for meta-analysis of proportions. The model essentially hierarchical logistic regression model guideline as the random-effects without any covariates.

Association between disagreements and search dates

We also explored whether the disagreements could be explained by the differences in search dates by the Cochrane reviews and guideline authors (i.e., a more up-to-date search by the guideline authors).

We identified nine clinical practice guidelines in total which included 62 guideline statements that were also covered in the seven Cochrane reviews. These included two guidelines from AASLD^20,21, three from BSG^22-24, one from EASL²⁵, and three from NICE^26-28. The guideline, the last search date for evidence, and the number of guideline statements for each guideline is listed in Table 1. The Cochrane topics covered by each guideline is listed in Table 2.

Extended Data Table 2 outlines the recommendation systems used in the CPGs. Cochrane reviews present the evidence according to the GRADE system¹⁷. In the EASL guidelines, the authors had assigned the strength of recommendation for each given statement, according to similar factors: quality of evidence, patient values/preferences, and costs. Several of the BSG guidelines also had the strength of recommendation for each statement assigned by the guideline authors, although the criteria for this assessment was not specified. The AASLD guidelines and the NICE guidelines did not contain the strength of recommendations; for these, the strengths of recommendation were independently assigned by DR and KG (differences resolved through discussion) based on the words suggested by the GRADE working group for strong and weak recommendation¹⁷.

Extended Data Table 3 presents the comparisons in strength of recommendation between the various CPGs and the relevant Cochrane review. The overall extent of agreement in the strength of recommendation in each CPG statement compared to the relevant Cochrane review is shown in Figure 1, with results for an individual CPG ranging from 0% to 100.0% agreement. Overall, the proportion of guideline statements where there was agreement between the guideline authors and the published Cochrane systematic reviews was 0.145 (95% confidence intervals (CI) 0.077 to 0.256). In other words, there was disagreement for 85.5% of the guideline statements. Only four statements were disagreement with the recommendation for or against an intervention. This was because the statement was unsupported by the evidence. These are listed in Table 3. All the remaining disagreements were related to the strength of the recommendation: in each case of disagreement in strength, the strength of recommendation in the CPG was overstated compared to evidence from the Cochrane review.

Extended Data Table 4 presents the search dates of the CPG compared to the Cochrane search dates. AASLD 2021 guideline had the most recent search date²¹, yet agreement was recorded as 0%, with none of the strength of recommendation in the 7 guideline statements found to match those from the Cochrane reviews. Similarly, the EASL 2018 guideline search date of March 2018²⁵ was comparable to the Cochrane reviews ranging from November 2018 to December 2019, but agreement was only recorded to be 14.8%. When agreement in guidelines with at least two relevant guideline statements were considered, the highest agreement (50%) out of the CPGs in our sample was with the BSG guideline on the role of TIPS in the management of portal hypertension which had a search date of October 2019²³. This contrasts with the BSG 2020 guideline on management of ascites, published by the same organisation and likely to have a more recent search date (exact date not stated but the guideline was published online in October 2020)²⁴, which only showed 25% agreement. Furthermore, the NICE NG50 guideline had one of the oldest search dates (August 2015)²⁸, yet was found to have the second highest agreement rate among the guidelines with at least two relevant guideline statement (33.3%). Therefore, we did not see a relationship in the association between search date and agreement with Cochrane review findings; i.e. the search dates did not explain the discrepancy between the CPG and Cochrane systematic review conclusions.

Only two guidelines had potential search dates later than the Cochrane review: AASLD 2021 and BSG 2020^21,24. None of the discordances in these two guidelines were due to additional randomised clinical trials (RCTs) published on the topics covered by the relevant statements since the search date of the Cochrane reviews.

Slight discrepancies in recommendations across different CPGs are commonplace across many clinical specialities and topics^29-31, due to differences in interpretation of evidence. However, if the underlying evidence used in CPG production is the same as in the Cochrane reviews, then it is necessary to understand why recommendations differ considerably. The results of this exploratory study found systematic discord in a considerable majority of statements (85.5%), in the recommendation (4/62) or the strength of recommendation (49/62) given in the CPG compared to those derived from the Cochrane reviews. When discrepancy between the CPG recommendation and the Cochrane review occurred, this was mainly related to the strength of recommendation, which was consistently overstated by the CPG developers.

This is an exploratory study and we focused only on guideline statements related to recent Cochrane reviews. This was because we were familiar with the evidence available on these topics. These Cochrane reviews were peer reviewed by experts and were considered to be at low risk of bias according to the ROBIS tool to assess the risk of bias in systematic reviews³². We limited the inclusion to the major organisations that develop guidelines related to liver disease as we felt that these were most likely to be in clinical use at the present time. Nevertheless, we know that there are many other guideline-producing parties (e.g. the BAVENO meetings) and we do not know if and how much these are in concordance with evidence.

In this study, we observed that even when the same system was used for development of recommendation by the same organisation, the discordance between guideline authors and Cochrane reviews were different. For example, BSG 2019 and BSG 2020 used the same system for grading recommendations. However, the discordance proportions were different. This might be because of differences in the number of guidelines that were eligible for the exploratory study or could be because of different guideline panel members.

Additionally, there were several instances where study authors DR and KG noted a mismatch between the language used by the guideline developers and the assigned strength of recommendation. There were also disagreements as to whether the recommendation was strong or weak for some guideline statements. For example, our review panel had different views on whether the sentence “Current evidence on the safety of subcutaneous automated low-flow pump implantation for refractory ascites shows there are serious but well-recognised safety concerns, including device failure and acute kidney injury. Evidence on efficacy is limited in quantity. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research” indicates a strong or weak recommendation by the guideline authors. We considered the recommendation to be weak for the purpose of the calculation of agreement as the guideline authors acknowledged the uncertainty in evidence. In other instances, the guideline authors had used words relevant to strong recommendation in their CPG statement, although they rated the recommendation as weak, for example, “Patients who have recovered from an episode of spontaneous bacterial peritonitis (SBP) should be considered for treatment with norfloxacin (400 mg once daily), ciprofloxacin (500 mg once daily, orally) or cotrimoxazole (800 mg sulfamethoxazole and 160 mg trimethoprim daily, orally) to prevent further episode of SBP” suggests a strong recommendation from the words used according to GRADE recommendations, but the guideline authors indicate that this is a weak recommendation. The appropriate words for the weak recommendation should, according to our point of view, have been “Patients who have recovered from an episode of SBP might be considered for treatment with norfloxacin…”.

There may be several potential reasons for discordance between the CPG statements and our Cochrane reviews. One reason for this difference is the difference in search dates. Only two guidelines had potential search dates later than the Cochrane review: AASLD 2021 and BSG 2020^21,24. None of the discordances in these two guidelines were due to additional RCTs published on the topics covered by the relevant statements since the search date of the Cochrane reviews. It is essential for systematic reviews as well as clinical guidelines and thus recommendations, to be regularly updated to incorporate new evidence. We have noted the NICE 2020 surveillance report indicating that NICE guideline NG50 is currently in the process of being updated for this reason²⁸. We do not know when the updates of the remaining guidelines will be performed and whether the discordance would be less when these guidelines are updated.

Another reason for discordance could be the type and quality of evidence considered in the publications included in the review process for the guideline forming the basis for the recommendations. For example, the Cochrane reviews in our sample included only RCTs that reported the results as the source of evidence underlying the conclusions. However, we noted that most of the clinical guidelines included non-randomised studies including retrospective cohort studies, case series, other observational studies, or consensus opinions from expert panels (which would have included personal clinical experience) . Although RCTs are regarded as the primary research study type at the top of the hierarchy of evidence^1,2, the rigour of the design of the RCTs is just as important as the study type. A poorly conducted RCT cannot be considered better than a well-conducted cohort study. Cochrane reviews contained assessment of the risk of bias of each included RCT and took these assessments into consideration while making recommendations. CPG guidelines did not report such a systematic assessment of the studies supporting the guideline statement. Agrawal and colleagues³³ investigated the robustness of RCTs included in the previous AASLD 2012 clinical guideline in terms of random errors, and found a significant proportion of the RCTs (62%) were fragile (i.e. only a few ‘non-events’ needed to be changed to ‘events’ to result in change in the recommendations). The Cochrane reviews that we used for this study used the GRADE system which includes consideration of random errors in determining uncertainty. Therefore, it is possible that the strength of the recommendations in the CPG could have been influenced by the non-randomised studies or small RCTs with relatively small treatment effects, which would have resulted in greater uncertainty in evidence if GRADE guidance was followed.

It is important to recognise that there are situations where there can be strong recommendations made even when there is low certainty evidence. This is clearly outlined in Table 6.3 of the GRADE Handbook¹⁷, for example when low quality evidence suggests benefit in a life-threatening situation, or when high-quality evidence suggests modest benefits and low quality evidence suggests the possibility of low incidence but occasional catastrophic harms. However, if such a scenario existed, it should be highlighted in the guideline. Through independent assessment and arbitration, we did not determine that any of these exception criteria applied in the statements included in this study, that would have warranted the strength of recommendation to have been increased.

Another possible reason for the discordance could be personal conflicts of interest (COI)^34,35. As may be expected, Nejstgaard and colleagues since reported that financial COI are associated with favourable recommendations in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews ³⁵. Although more difficult to characterise and evaluate, non-financial conflicts of interest are also likely to introduce bias in CPG recommendations, e.g. for a specific named drug or formulation rather than a generic group without evidence to justify.

The systematic overrating of strength of recommendations in CPGs, highlighted from this work, has major implications in healthcare, as this is often the basis upon which clinicians pursue and advise patients on particular treatment choices and therefore significantly impacts on the clinical shared decision-making process. Although treatment decisions are not bound or dictated by clinical guidelines, healthcare professionals may fear potential medical negligence lawsuits if deciding to practice outside of recommendations contained within clinical guidelines³⁶ and may not have the time or opportunity to investigate the quality of evidence behind the guideline recommendations. Furthermore, one would expect use of resources to increase in line with those pertaining to strong recommendation statements in CPGs, as healthcare professionals proceed to implement these more frequently in practice. The reverse is true with regard to research: further research may be limited in areas with strong recommendations if it is perceived that there is a lack of clinical equipoise or that no uncertainty needs to be addressed³⁷. Therefore, in the endeavour of evidence-based health care with best patient treatment and care as the fundamental cornerstones, it is imperative for clinical practice guidelines not to be flawed by systematic overrating of the strength of recommendation or poor rigour of development of the guideline³⁸.

Our findings corroborate with those found by several previous studies which point at discordances between strength of recommendations and evidence supporting the recommendation for a high proportion of guideline statements^15,16,39. This is similar to the worst form of spin found in systematic reviews, i.e. recommendations for clinical practice were not being supported by the study findings in systematic reviews⁴⁰.

The major weakness in our study is that there was no published protocol or statistical analysis plan. Therefore, this study should be considered only exploratory. Second, we did not assess whether the disagreements could be explained by the methodological quality of the clinical practice guidelines, for example, AGREE II⁴¹. Third, as we are authors of or editors of the Cochrane Hepato-Biliary Group reviews we cannot nullify a suspicion that we could be more biased towards the recommendations of the reviews. However, we have reported our findings transparently and they are open to international scrutiny and contest.

In conclusion, our findings suggest that there may be a systematic issue with guideline authors overstating the strength of recommendations in clinical practice guidelines on advanced liver cirrhosis. This could not be explained by the search dates or scenarios which warranted strong recommendations despite low certainty evidence. Therefore, we propose that future work should be conducted to understand why evidence is interpreted differently despite having an accepted methodology for developing clinical practice guidelines. Further research is also needed to understand the clinician and patient perspective of guidelines which provide definitive guidance even when the quality of evidence is weak. Such a definitive study should have a registered protocol and statistical analysis plan prior to the start of the study and investigate whether AGREE II domains can explain the discordance between evidence and CPG recommendations. Research is also necessary to study whether automated checks to ensure that the wording chosen matches the strength of recommendation can decrease the mismatch between the words used in the guideline statement and the strength of recommendation.

Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Systematic Reviews Programme (project number 16/114/17).

Acknowledgements

This project was funded by the National Institute for Health and Care Research (NIHR) Systematic Reviews Programme (project number 16/114/17).

Author contributions

KG conceived the idea. KG and DR identified the guidelines and extracted the data. KG analysed the data. KG, DR, and JL prepared the data in a format suitable for analysis. JL checked for randomised clinical trials used in the guidelines and published since the last date of search of the Cochrane review. DR and KG interpreted the data and drafted the review. JL, CG, DN, CP, and BD interpreted the data and revised the text critically for important intellectual content. All authors approved the final version to be published.

Competing interest declaration

Many authors of this manuscript are authors or the editors of the Cochrane reviews.

Additional information

Supplementary Information is available for this paper – Appendix 1

Correspondence to Dr Danielle Roberts, [email protected]

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Tables 1 to 3 are available in the Supplementary Files section

Yes there is potential Competing Interest. Many authors of this manuscript are authors or the editors of the Cochrane reviews

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Comparison of recommendations from cirrhosis Clinical Practice Guidelines and from Cochrane systematic reviews

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Abstract

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Summary

Introduction

Methods

Guideline selection

Data collection and processing

Analysis

Association between disagreements and search dates

Results

Discussion

Declarations

References

Tables

Additional Declarations

Supplementary Files

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