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Journal ArticleDOI

Ability of King's College Criteria and Model for End-Stage Liver Disease Scores to Predict Mortality of Patients With Acute Liver Failure: A Meta-analysis

01 Apr 2016-Clinical Gastroenterology and Hepatology (Clin Gastroenterol Hepatol)-Vol. 14, Iss: 4, pp 516-525

TL;DR: Based on a meta-analysis of studies, the KCC more accurately predicts hospital mortality among patients with AALF, whereas MELD scores more accurately predict mortalityamong patients with NAALF.

AbstractBackground & Aims Several prognostic factors are used to identify patients with acute liver failure (ALF) who require emergency liver transplantation. We performed a meta-analysis to determine the accuracy of King's College criteria (KCC) versus the model for end-stage liver disease (MELD) scores in predicting hospital mortality among patients with ALF. Methods We performed a systematic search of the literature for articles published from 2001 through 2015 that compared the accuracy of the KCC with MELD scores in predicting hospital mortality in patients with ALF. We identified 23 studies (comprising 2153 patients) and assessed the quality of data, and then performed a meta-analysis of pooled sensitivity and specificity values, diagnostic odds ratios (DORs), and summary receiver operating characteristic curves. Subgroups analyzed included study quality, era, location (Europe vs non-Europe), and size; ALF etiology (acetaminophen-associated ALF [AALF] vs nonassociated [NAALF]); and whether or not the study included patients who underwent liver transplantation and if the study center was also a transplant center. Results The DOR for the KCC was 5.3 (95% confidence interval [CI], 3.7–7.6; 57% heterogeneity) and the DOR for MELD score was 7.0 (95% CI, 5.1–9.7; 48% heterogeneity), so the MELD score and KCC are comparable in overall accuracy. The summary area under the receiver operating characteristic curve values was 0.76 for the KCC and 0.78 for MELD scores. The KCC identified patients with AALF who died with 58% sensitivity (95% CI, 51%–65%) and 89% specificity (95% CI, 85%–93%), whereas MELD scores identified patients with AALF who died with 80% sensitivity (95% CI, 74%–86%) and 53% specificity (95% CI, 47%–59%). The KCC predicted hospital mortality in patients with NAALF with 58% sensitivity (95% CI, 54%–63%) and 74% specificity (95% CI, 69%–78%), whereas MELD scores predicted hospital mortality in patients with NAALF with 76% sensitivity (95% CI, 72%–80%) and 73% specificity (95% CI, 69%–78%). In patients with AALF, the KCC's DOR was 10.4 (95% CI, 4.9–22.1) and the MELD score's DOR was 6.6 (95% CI, 2.1–20.2). In patients with NAALF, the KCC's DOR was 4.16 (95% CI, 2.34–7.40) and the MELD score's DOR was 8.42 (95% CI, 5.98–11.88). Conclusions Based on a meta-analysis of studies, the KCC more accurately predicts hospital mortality among patients with AALF, whereas MELD scores more accurately predict mortality among patients with NAALF. However, there is significant heterogeneity among studies and neither system is optimal for all patients. Given the importance of specificity in decision making for listing for emergency liver transplantation, MELD scores should not replace the KCC in predicting hospital mortality of patients with AALF, but could have a role for NAALF.

Summary (2 min read)

Jump to: [INTRODUCTION][METHODS][NAALF).][RESULTS][DISCUSSION] and [OLT.]

INTRODUCTION

  • Acute Liver Failure (ALF) is a rare, but devastating illness with a high risk of progression to multi-organ failure and death1-3.
  • The key clinical issue remains to accurately identify patients with ALF who will die without ELT, and those who will survive with medical management alone.
  • One particularly salient difference is the treatment of transplanted patients.
  • To date, there have been three meta-analyses23 of the performance of the KCC in ALF.
  • The first included only Acetaminophen-induced ALF (AALF) identifying nine studies in total, and concluded that the KCC had limited sensitivity13.

METHODS

  • All potential articles were assessed independently by two researchers (HF, MM) according to prospectively defined eligibility criteria, and disagreements were resolved by consensus or consultation with a third author (WB).
  • If this was not possible or there was doubt over the 2 x 2 calculation, the study was excluded from the subsequent analysis.
  • The DerSimonian-Laird random effects method was used to produce summary estimates of sensitivity, specificity, likelihood ratios (LR) and diagnostic odds ratio (DOR, defined as the ratio of positive to negative likelihood ratios).

NAALF).

  • A funnel plot and effective sample size (ESS) regression analysis (the logarithm of the DOR plotted against 1/√ESS) was used to investigate publication bias.
  • Data analyses were performed using the freeware Meta-Disc version 1.4 (Universidad Complutense, Madrid, Spain) and Eggers statistic calculated in Excel (Microsoft Corporation, Redmond WA)33.

RESULTS

  • The search strategy identified 4,063 potentially relevant studies.
  • Subgroup analysis was performed to assess differences in heterogeneity and diagnostic accuracy between the groups specified earlier.
  • Furthermore Egger's statistic was not significant again suggesting publication bias was not present.

DISCUSSION

  • This meta-analysis confirms that when comparing KCC and MELD for outcome prediction in ALF KCC have lower sensitivity and MELD lower specificity.
  • The sROC analysis is therefore a more valid way to pool the results of studies with varying thresholds.
  • This is no doubt a consequence of the fact that the KCC were derived from an ALF cohort, whereas MELD was developed from results in chronic liver disease patients undergoing TIPS.
  • This may be why KCC is preferred in countries facing such organ shortages and with high rates of AALF.
  • Clearly such delays are relatively short but in cases of fulminant hepatic failure it is clearly advantageous to use simpler bedside tests during the evolution of disease.

OLT.

  • Information on prothrombin time measurements and assay details were not available in all studies and may have contributed to heterogeneity or threshold effects.
  • The potential benefits of combining the specificity of the KCC with the sensitivity of MELD are attractive.
  • Such novel methods would require data for each patient rather than summative as presented for publication.
  • Many new biomarkers have been proposed in ALF but have failed to be validated in larger studies or are deemed not ready for widespread distribution.
  • Neither KCC nor MELD are optimal in all circumstances so there remains an urgent need for more accurate outcome prediction systems in ALF.

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Meta-Analysis of King's College Criteria and Model for End
Stage Liver Disease to Predict Outcome in Acute Liver Failure
Mark JW McPhail
1,2
*, Hugo Farne
1
*, Naz Senvar
2
, Julia A Wendon
1
and William Bernal
1
1
Liver Intensive Therapy Unit, Institute of Liver Studies, King’s College Hospital, Denmark Hill, London
2
Department of Hepatology, St Mary's Hospital, Imperial College London, South Wharf Road, Paddington, London
*These authors contributed equally to this article
Correspondence-
Dr Mark McPhail
Liver Intensive Therapy Unit
Institute of Liver Studies
Kings College Hospital
Denmark Hill
London SE5 9RS
Email m.mcphail@csc.mrc.ac.uk
Phone +44 (0)20 3299 9000
Fax +44 (0)20 3299 3167

Electronic word count - 3154
Number of tables 3 Number of figures 3 (+2 Supplemental)
Abbreviations-
AALF Acetaminophen Acute Liver Failure
ALF Acute Liver Failure
DOR Diagnostic Odds Ratio
ELT Emergency Liver Transplantation
FPR False Positive Rate
KCC King's College Criteria
LR Likelihood Ratio
MELD Model for End Stage Liver Disease
NAALF Non-Acetaminophen Acute Liver Failure
ROC Receiver Operator Curve
sROC Summary Receiver Operator Curve
STARD STandards for the Reporting of Diagnostic Accuracy
TIPS Transjugular Intrahepatic Portosystemic Shunt
TPR True Positive Rate
Disclosures-
MJWM is grateful to the National Institute for Health Research, UK Biomedical Research Centre at
Imperial College London for infrastructure support. There are no relevant conflicts of interest.
Grant Support-
MJWM was supported by the Wellcome Trust, UK as part of a Postdoctoral Training Fellowship
during the production of this article
Author Contributions-
HF, MM and NS performed the literature search, identified studies for inclusion, extracted the data,
and performed the analysis. MM and HF and drafted the manuscript. WB ratified the literature
search and extracted data. The remaining authors revised the manuscript. WB is the guarantor.

ABSTRACT
Background & Aims
Prognostication in Acute Liver Failure (ALF) aims to identify patients who require Emergency Liver
Transplantation (ELT). We assessed the accuracy of King's College Criteria (KCC) versus the Model-for-
End-Stage-Liver-Disease (MELD) in ALF through meta-analysis of studies which report the accuracy of
both tests.
Methods
After systematic literature search and quality assessment collated data was meta-analysed for pooled
sensitivity, specificity, Diagnostic Odds Ratio (DOR) and summary Receiver Operator Curve (sROC)
analysis. Subgroup analysis was defined by study quality; era; size; aetiology (acetaminophen v non-
acetaminophen AALF v NAALF); location (Europe vs. non-Europe), ELT centre, and inclusion of patients
undergoing ELT.
Results
Twenty three studies with data for 2153 patients published between 2006 and 2015 were retrieved.
The DOR for KCC was 5.3 (95% CI 3.7-7.6, heterogeneity 57%) and 7.0 (5.1-9.7, heterogeneity 48%) for
MELD indicating comparable overall accuracy; the sAUROC for KCC was 0.76 and 0.78 for MELD. For
AALF the sensitivity was 58(51-65)% and specificity 89(85-93)% for KCC, vs. sensitivity 80 (74-86)% and
specificity 53(47-59)% for MELD. For NAALF the sensitivity was 58(54-63) % and specificity 74(69-78)%
for KCC, vs. sensitivity 76(72-80)% and specificity 73 (69-78)% for MELD. The DOR for KCC in cases of
AALF was 10.4(4.9-22.1) and for MELD 6.6 (2.1-20.2) whereas for NAALF the DOR for KCC was 4.16
(2.34-7.40) and 8.42 (5.98-11.88) for MELD.
Conclusions
Although KCC performs better for AALF, MELD has improved prognostic accuracy in NAALF with
significant heterogeneity in published studies and neither is optimal in all scenarios. Given the critical
importance of loss of specificity in ELT wait-listing decisions, MELD should not replace KCC in AALF,
but may have a role in NAALF.
Keywords Acute liver failure; Meta-analysis; Liver transplantation.

INTRODUCTION
Acute Liver Failure (ALF) is a rare, but devastating illness with a high risk of progression to multi-organ
failure and death
1-3
. Outcomes in ALF improved with the advent of Emergency Liver Transplantation
(ELT) in the 1980s
4
, and further improvements have occurred recently with modern intensive care
practices
5
. The key clinical issue remains to accurately identify patients with ALF who will die without
ELT, and those who will survive with medical management alone. Failure to identify those in need of
ELT results in a potentially preventable death. Conversely, wrongly classifying prospective survivors as
in need of ELT subjects the patient to the morbidity and mortality associated with transplantation. In
addition a graft is removed from the donor pool.
Multiple prognostic systems have been developed to aid decision making for ELT. The longest
established are the King’s College Criteria (KCC)
6
. These were derived from a retrospective analysis of
588 patients from the pre-transplant era 1973-1985, and have subsequently been validated in many
centres
7-11
. Recognising that there are differences in the natural history of Acetaminophen-induced
ALF (AALF) and Non-Acetaminophen-induced ALF (NAALF), separate criteria were derived for each.
The KCC demonstrate high specificity, but have been criticised for their low sensitivity and negative
predictive value for a poor outcome
12, 13
. Nevertheless these easy-to-use criteria have consistently
outperformed novel scoring systems and remain the benchmark for prognostication in ALF.
With concerns about the low sensitivity of the KCC to predict mortality in ALF, clinicians have sought
alternatives that might outperform the KCC, including the Model for End-stage Liver Disease (MELD)
score
14-16
. Early reports noted the moderate accuracy of MELD as an alternative to the KCC in ALF
17
.
However it appears that whilst MELD has higher sensitivity for predicting death in ALF than the KCC,
it may have a lower specificity for predicting survival
18
.

While a body of evidence has emerged comparing the KCC and MELD, controversy remains over which
scoring system has the superior diagnostic accuracy
19, 20
. The conflicting results to date may be
explained by differences in design and relatively small sample sizes (the largest study had 380
patients). One particularly salient difference is the treatment of transplanted patients. Authors must
decide whether to include patients with ALF who received ELT as non-survivors, which may not
necessarily be the case, or to exclude them altogether in either case introducing bias which is not
present in reports from the pre-ELT era. There are also differences in study location (with differing
resources and guidelines in each, and a lack of international standardisation of laboratory variables
21,
22
), the date range reviewed (with possible changes in disease spectrum and efficacy of supportive
management over time), and aetiologies included (all ALF or a subset i.e. AALF, NAALF, viral hepatitis,
or anti-tuberculous chemotherapy-induced ALF).
To date, there have been three meta-analyses
23
of the performance of the KCC in ALF. The first
included only Acetaminophen-induced ALF (AALF) identifying nine studies in total, and concluded that
the KCC had limited sensitivity
13
. A later study updated this meta-analysis for AALF to include a further
five studies, and found that the KCC had high diagnostic accuracy
24
. However given previous reports
have found the KCC to be superior in AALF than in the subset with Non-Acetaminophen-induced ALF
(NAALF),
25
a later meta-analysis assessed the KCC in NAALF, again finding that the KCC have high
overall accuracy and in particular good specificity if more limited sensitivity
26
.
There are no published meta-analyses assessing the performance of MELD in ALF, nor any comparing
MELD and the KCC. The aim of this study was to quantitatively assess and compare the prognostic
accuracy of KCC and MELD in ALF through a meta-analysis of all studies reporting the diagnostic
accuracy of both prognostic schema in the same population.

Citations
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TL;DR: This ACG Clinical Guideline is presented an evidence-based approach to diagnosis and management of DILI with special emphasis on DILi due to herbal and dietary supplements and DilI occurring in individuals with underlying liver disease.
Abstract: 6, on behalf of the Practice Parameters Committee of the American College of Gastroenterology Idiosyncratic drug-induced liver injury (DILI) is a rare adverse drug reaction and it can lead to jaundice, liver failure, or even death. Antimicrobials and herbal and dietary supplements are among the most common therapeutic classes to cause DILI in the Western world. DILI is a diagnosis of exclusion and thus careful history taking and thorough work-up for competing etiologies are essential for its timely diagnosis. In this ACG Clinical Guideline, the authors present an evidence-based approach to diagnosis and management of DILI with special emphasis on DILI due to herbal and dietary supplements and DILI occurring in individuals with underlying liver disease.

485 citations


Cites background from "Ability of King's College Criteria ..."

  • ...In patients with DILI who developed ALF, the King’s College criteria or the US ALF Study Group criteria for non-APAP ALF can be applied for assessing the prognosis and for timing liver transplant evaluation, but these models are not specific for DILI (73,74)....

    [...]


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TL;DR: The term acute liver failure (ALF) is frequently applied as a generic expression to describe patients presenting with or developing an acute episode of liver dysfunction, however, it refers to a highly specific and rare syndrome, characterised by an acute abnormality of liver blood tests in an individual without underlying chronic liver disease.
Abstract: The term acute liver failure (ALF) is frequently applied as a generic expression to describe patients presenting with or developing an acute episode of liver dysfunction. In the context of hepatological practice, however, ALF refers to a highly specific and rare syndrome, characterised by an acute abnormality of liver blood tests in an individual without underlying chronic liver disease. The disease process is associated with development of a coagulopathy of liver aetiology, and clinically apparent altered level of consciousness due to hepatic encephalopathy. Several important measures are immediately necessary when the patient presents for medical attention. These, as well as additional clinical procedures will be the subject of these clinical practice guidelines.

320 citations


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TL;DR: N-acetylcysteine is recommended for all patients with APAP-induced ALF and it reduces mortality and Liver transplantation should be offered early to those who are unlikely to survive based on described prognostic criteria.
Abstract: Acetaminophen (APAP) is the leading cause of acute liver failure (ALF), although the worldwide frequency is variable APAP hepatotoxicity develops either following intentional overdose or unintentional ingestion (therapeutic misadventure) in the background of several factors, such as concomitant use of alcohol and certain medications that facilitate the formation of reactive and toxic metabolites Spontaneous survival is more common in APAP-induced ALF compared with non-APAP etiologies N-acetylcysteine is recommended for all patients with APAP-induced ALF and it reduces mortality Liver transplantation should be offered early to those who are unlikely to survive based on described prognostic criteria

56 citations


Journal ArticleDOI
TL;DR: The current diagnostic and therapeutic approach to acute liver failure is reviewed, especially in the intensive care unit setting, to improve patients' outcomes and selection of patients for liver transplantation.
Abstract: Acute liver failure is a rare but potentially devastating disease. Throughout the last few decades, acute liver failure outcomes have been improving in the context of the optimized overall management. This positive trend has been associated with the earlier recognition of this condition, the improvement of the intensive care unit management, and the developments in emergent liver transplantation. Accordingly, we aimed to review the current diagnostic and therapeutic approach to this syndrome, especially in the intensive care unit setting.

42 citations


Cites background from "Ability of King's College Criteria ..."

  • ...A recent metaanalysis has revealed its prognostic ability in comparison with the MELD score: for acetaminophen-related ALF, sensitivities were 58% and 80%, respectively, and specificities were 89% and 53%, respectively; for non-acetaminophen etiologies, sensitivities were 58% and 76%, respectively, and specificities were 74% and 73%, respectively [73]....

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Journal ArticleDOI
TL;DR: This work reviewed the implicated drugs, clinical features, laboratory characteristics and outcome of patients with drug‐induced ALF (DIALF), and analysed the predictors of mortality and their relationship with MELD, KCC, and ALFSG prognostic index.
Abstract: BACKGROUND & AIMS Drugs producing acute liver failure (ALF) are uncommon and vary geographically. Here we review the implicated drugs, clinical features, laboratory characteristics and outcome of patients with drug-induced ALF (DIALF). We analysed the predictors of mortality and their relationship with MELD, King's College criteria (KCC) and ALFSG prognostic index. METHODS We identified DIALF patients from our drug-induced liver injury (DILI) registry (1997-2017). RUCAM was used for case adjudication. Patients who fulfilled criteria for acute liver failure and drug-induced liver injury were included. Primary outcome measure was spontaneous survival or death. RESULTS There were 128 cases of DIALF (14%) among 905 patients with DILI. Mean age was 38 years, 68 (53%) female and 21(16.4%) children <18 years. Combination anti-TB drugs (ATD) (n = 92, 72.4%) accounted for a majority of DIALF. Others were anti-epileptic drugs (AED, n = 11, 10%), dapsone (n = 7, 5.5%), hormones (n = 2), ferrous sulphate overdose (n = 2), acetaminophen (APAP) (n = 2), antiretroviral (n = 2), CAM (N = 2), chemotherapy agents (N = 3), amoxicillin-clavulanic acid (n = 2) and others (n = 3). Forty-four patients (34%) recovered spontaneously and 84(66%) including 13 children (62%) died. Females, ascites, albumin, bilirubin, INR and MELD were significantly associated with mortality. Mortality was 79% for ATD and 100% for APAP and iron overdose. Area under ROC was 0.76 for MELD and ALFSG index and 0.51 for KCC. CONCLUSIONS Fourteen percent of DILI resulted in DIALF. ATD, AED, dapsone and antiretroviral drugs are most common agents. Spontaneous survival was only 34% with an even higher mortality with ATD. Non-ATD and non-APAP drugs had a better survival (51%).INR and MELD predicted mortality.

33 citations


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TL;DR: The MELD scale is a reliable measure of mortality risk in patients with end‐stage liver disease and suitable for use as a disease severity index to determine organ allocation priorities in patient groups with a broader range of disease severity and etiology.
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Abstract: Transjugular intrahepatic portosystemic shunts (TIPS) may worsen liver function and decrease survival in some patients. The Child-Pugh classification has several drawbacks when used to determine survival in such patients. The survival of 231 patients at 4 medical centers within the United States who underwent elective TIPS was studied to develop statistical models to (1) predict patient survival and (2) identify those patients whose liver-related mortality post-TIPS would be 3 months or less. Among these elective TIPS patients, 173 had the procedure for prevention of variceal rebleeding and 58 for treatment of refractory ascites. Death related to liver disease occurred in 110 patients, 70 within 3 months. Cox proportional-hazards regression identified serum concentrations of bilirubin and creatinine, international normalized ratio for prothrombin time (INR), and the cause of the underlying liver disease as predictors of survival in patients undergoing elective TIPS, either for prevention of variceal rebleeding or for treatment of refractory ascites. These variables can be used to calculate a risk score (R) for patients undergoing elective TIPS. Patients with R > 1.8 had a median survival of 3 months or less. This model was superior to both the Child-Pugh classification, as well as the Child-Pugh score, in predicting survival. Using logistic regression and the same variables, we also developed a nomogram that indicates which patients survive less than 3 months. Finally, the model was validated among an independent set of 71 patients from the Netherlands. This Mayo TIPS model may predict early death following elective TIPS for either prevention of variceal rebleeding or for treatment of refractory ascites.

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TL;DR: The primary aim was to compare presenting clinical features and liver transplantation in patients with acute liver failure related to acetaminophen hepatotoxicity, other drugs, indeterminate factors, and other causes.
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Frequently Asked Questions (2)
Q1. What have the authors contributed in "Meta-analysis of king's college criteria and model for end stage liver disease to predict outcome in acute liver failure" ?

The authors assessed the accuracy of King 's College Criteria ( KCC ) versus the Model-forEnd-Stage-Liver-Disease ( MELD ) in ALF through meta-analysis of studies which report the accuracy of both tests. 

The authors hope these data help inform such decisions and future research. A worsening grade of HE can be detected at the bedside and incorporated into KCC without awaiting further biochemical analysis.