Reference Citation Analysis: Find an Article, Find a Category, Find a Journal, Find a Scholar

For: Koh C, Zhao X, Samala N, Sakiani S, Liang TJ, Talwalkar JA. AASLD clinical practice guidelines: a critical review of scientific evidence and evolving recommendations. Hepatology 2013;58:2142-52. [PMID: 23775835 PMCID: PMC4613804 DOI: 10.1002/hep.26578] [Citation(s) in RCA: 50] [Impact Index Per Article: 4.2] [Reference Citation Analysis] [What about the content of this article? (0)] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/18/2013] [Accepted: 06/05/2013] [Indexed: 12/11/2022]

For:	Koh C, Zhao X, Samala N, Sakiani S, Liang TJ, Talwalkar JA. AASLD clinical practice guidelines: a critical review of scientific evidence and evolving recommendations. Hepatology 2013;58:2142-52. [PMID: 23775835 PMCID: PMC4613804 DOI: 10.1002/hep.26578] [Citation(s) in RCA: 50] [Impact Index Per Article: 4.2] [Reference Citation Analysis] [What about the content of this article? (0)] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/18/2013] [Accepted: 06/05/2013] [Indexed: 12/11/2022]

Number

Cited by Other Article(s)

Mlewa M, Nyawale HA, Henerico S, Mangowi I, Shangali AR, Manisha AM, Kisanga F, Kidenya BR, Jaka H, Kilonzo SB, Mirambo MM, Mshana SE. Hepatitis B infection: Evaluation of demographics and treatment of chronic hepatitis B infection in Northern-western Tanzania. PLoS One 2024;19:e0309314. [PMID: 39378209 PMCID: PMC11460692 DOI: 10.1371/journal.pone.0309314] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/09/2024] [Accepted: 08/08/2024] [Indexed: 10/10/2024] Open

Abstract

BACKGROUND

Chronic hepatitis B virus (HBV) infection is still a major public health problem. In response to the World Health Organization (WHO), Tanzania implemented immunization and treatment to achieve the eradication of HBV infection by 2030. To achieve this goal, frequent updates of demographic data, antiviral therapy eligibility, and uptake are essential. We therefore evaluated demographic data, antiviral therapy eligibility, and uptake among chronically HBV-infected patients attending at Bugando Medical Centre (BMC), Tanzania.

METHODS

A cross-sectional study enrolled 196 chronic HBV patients from April 23, 2023, to October 10, 2023, at BMC, where 100 and 96 patients were retrospectively and prospectively enrolled, respectively. Study's ethical clearance and permission were observed by the Catholic University of Health and Allied Sciences/Bugando Medical Centre research ethics and review committee and the Bugando Medical Centre management respectively. For all patients, socio-demographic data and whole blood samples were obtained. Full blood picture, alanine and aspartate amino transferases, and HBV viral load parameters were determined. Aspartate-Platelet Ratio Index (APRI) and Fibrosis Four (FIB-4) scores were calculated according to their respective formulas. Therapy eligibility and uptake were evaluated according to the 2015 WHO HBV prevention, treatment, and care guidelines. The data were summarized and analysed using STATA version 15.

RESULTS

The median age for all patients was 39 [IQR: 32-47.5] years. Nearly all study patients, 99% (194/196), were older than 20 years old, with significant male dominance (73.5% [144/196] versus 26.5% [52/196]; p<0.0001). Anti-HBV antiviral therapy eligibility was 22.4%, while uptake was 6.8% (3/4), which was significantly lower than the WHO expectation of 80% (p <0.0001).

CONCLUSION

Almost all chronically HBV-infected patients attending at BMC were older than 20 years old and were significantly dominated by males. Antiviral therapy uptake was remarkably lower than expected by the WHO towards combating HBV infection by 2030.

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Cho WT, Yoo T, Lee JM, Lee JW, Kim H, Lee JS, Han SH. Hepatitis B Virus DNA-Level Change is Associated With Tumor Recurrence in Patients With Resected Hepatitis B Virus Hepatocellular Carcinoma. J Surg Res 2024;295:231-239. [PMID: 38041902 DOI: 10.1016/j.jss.2023.10.002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/08/2023] [Revised: 09/07/2023] [Accepted: 10/07/2023] [Indexed: 12/04/2023]

Abstract

INTRODUCTION

To investigate the significance of perioperative hepatitis B virus (HBV) DNA changes for predicting recurrence in patients with HBV-related hepatocellular carcinoma (HCC) undergoing liver resection (LR).

METHODS

From 2013 to 2020, 241 patients with HBV-related HCC who underwent LR in five Hallym university-affiliated hospitals were enrolled. The serum HBV DNA level, together with other clinicopathological variables, was analyzed for association with HCC recurrence.

RESULTS

Preoperatively, 99 patients had undetectable HBV DNA and 142 had detectable viral levels. Of those with detectable viral levels, 72 rapidly progressed to undetectable levels within 3 mo after LR (Rapid group), and 70 showed persistently detectable levels (Nonrapid group). The Rapid group had a better recurrence-free survival (RFS) rate than the Nonrapid group (1-y, 3-y RFS = 75.4%, 57.3%, versus 54.7%, 39.9%, respectively, P = 0.012). In the subgroup analysis, the Rapid group had a better RFS rate in early stages (1-y, 3-y RFS = 82.6%, 68.5%, versus 62.8%, 45.8%, respectively, P = 0.005); however, the RFS rates between the two groups were comparable in the advanced stage (1-y, 3-y RFS = 61.1%, 16.7% versus 45.5%, 22.7%, respectively, P = 0.994). Among the 142 patients with preoperatively detectable HBV DNA, persistently detectable HBV DNA within 3 mo postoperatively (hazard ratio [HR] = 1.7, P = 0.022), large tumor size (HR = 2.7, P < 0.001), multiple tumors (HR = 3.2, P < 0.001), and microvascular invasion (HR = 1.7, P = 0.028) were independent risk factors for RFS in multivariate analysis.

CONCLUSIONS

Rapidly undetectable HBV DNA after LR is associated with a better prognosis for recurrence in patients with HCC. Therefore, appropriate treatment and/or screening may be necessary for patients who do not return to undetectable HBV DNA after LR.

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Croome KP, Barbas AS, Whitson B, Zarrinpar A, Taner T, Lo D, MacConmara M, Kim J, Kennealey PT, Bromberg JS, Washburn K, Agopian VG, Stegall M, Quintini C. American Society of Transplant Surgeons recommendations on best practices in donation after circulatory death organ procurement. Am J Transplant 2023;23:171-179. [PMID: 36695685 DOI: 10.1016/j.ajt.2022.10.009] [Citation(s) in RCA: 47] [Impact Index Per Article: 23.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/08/2022] [Revised: 09/19/2022] [Accepted: 10/14/2022] [Indexed: 01/13/2023]

Sempokuya T, Warner J, Azawi M, Nogimura A, Wong LL. Current status of disparity in liver disease. World J Hepatol 2022;14:1940-1952. [PMID: 36483604 PMCID: PMC9724102 DOI: 10.4254/wjh.v14.i11.1940] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/18/2022] [Revised: 11/09/2022] [Accepted: 11/16/2022] [Indexed: 11/24/2022] Open

Nascimento YDA, Silva LD, Ramalho de Oliveira D. The Lived Experience of Patients Utilizing Second-Generation Direct-Acting Antiviral for Treatment of Chronic Hepatitis C Virus Infection: A Phenomenological Analysis. INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH 2022;19:12540. [PMID: 36231842 PMCID: PMC9566709 DOI: 10.3390/ijerph191912540] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 08/19/2022] [Revised: 09/28/2022] [Accepted: 09/29/2022] [Indexed: 06/16/2023]

Lai AG, Chang WH, Parisinos CA, Katsoulis M, Blackburn RM, Shah AD, Nguyen V, Denaxas S, Davey Smith G, Gaunt TR, Nirantharakumar K, Cox MP, Forde D, Asselbergs FW, Harris S, Richardson S, Sofat R, Dobson RJB, Hingorani A, Patel R, Sterne J, Banerjee A, Denniston AK, Ball S, Sebire NJ, Shah NH, Foster GR, Williams B, Hemingway H. An informatics consult approach for generating clinical evidence for treatment decisions. BMC Med Inform Decis Mak 2021;21:281. [PMID: 34641870 PMCID: PMC8506488 DOI: 10.1186/s12911-021-01638-z] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/19/2021] [Accepted: 09/27/2021] [Indexed: 11/20/2022] Open

Abstract

BACKGROUND

An Informatics Consult has been proposed in which clinicians request novel evidence from large scale health data resources, tailored to the treatment of a specific patient. However, the availability of such consultations is lacking. We seek to provide an Informatics Consult for a situation where a treatment indication and contraindication coexist in the same patient, i.e., anti-coagulation use for stroke prevention in a patient with both atrial fibrillation (AF) and liver cirrhosis.

METHODS

We examined four sources of evidence for the effect of warfarin on stroke risk or all-cause mortality from: (1) randomised controlled trials (RCTs), (2) meta-analysis of prior observational studies, (3) trial emulation (using population electronic health records (N = 3,854,710) and (4) genetic evidence (Mendelian randomisation). We developed prototype forms to request an Informatics Consult and return of results in electronic health record systems.

RESULTS

We found 0 RCT reports and 0 trials recruiting for patients with AF and cirrhosis. We found broad concordance across the three new sources of evidence we generated. Meta-analysis of prior observational studies showed that warfarin use was associated with lower stroke risk (hazard ratio [HR] = 0.71, CI 0.39-1.29). In a target trial emulation, warfarin was associated with lower all-cause mortality (HR = 0.61, CI 0.49-0.76) and ischaemic stroke (HR = 0.27, CI 0.08-0.91). Mendelian randomisation served as a drug target validation where we found that lower levels of vitamin K1 (warfarin is a vitamin K1 antagonist) are associated with lower stroke risk. A pilot survey with an independent sample of 34 clinicians revealed that 85% of clinicians found information on prognosis useful and that 79% thought that they should have access to the Informatics Consult as a service within their healthcare systems. We identified candidate steps for automation to scale evidence generation and to accelerate the return of results.

CONCLUSION

We performed a proof-of-concept Informatics Consult for evidence generation, which may inform treatment decisions in situations where there is dearth of randomised trials. Patients are surprised to know that their clinicians are currently not able to learn in clinic from data on 'patients like me'. We identify the key challenges in offering such an Informatics Consult as a service.

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Affiliation(s)

Alvina G Lai Institute of Health Informatics, University College London, London, UK. Health Data Research UK, London, UK.
Wai Hoong Chang Institute of Health Informatics, University College London, London, UK Health Data Research UK, London, UK
Constantinos A Parisinos Institute of Health Informatics, University College London, London, UK
Michail Katsoulis Institute of Health Informatics, University College London, London, UK
Ruth M Blackburn Institute of Health Informatics, University College London, London, UK Health Data Research UK, London, UK
Anoop D Shah Institute of Health Informatics, University College London, London, UK University College London Hospitals NIHR Biomedical Research Centre, London, UK University College London Hospitals NHS Trust, London, UK
Vincent Nguyen Institute of Health Informatics, University College London, London, UK
Spiros Denaxas Institute of Health Informatics, University College London, London, UK Health Data Research UK, London, UK University College London Hospitals NIHR Biomedical Research Centre, London, UK The Alan Turing Institute, London, UK
George Davey Smith Medical Research Council Integrative Epidemiology Unit, University of Bristol, Bristol, UK Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
Tom R Gaunt Medical Research Council Integrative Epidemiology Unit, University of Bristol, Bristol, UK Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
Krishnarajah Nirantharakumar Health Data Research UK, London, UK Institute of Applies Health Research, University of Birmingham, Birmingham, UK
Murray P Cox Statistics and Bioinformatics Group, School of Fundamental Sciences, Massey University, Palmerston North, New Zealand
Donall Forde Public Health Wales, University Hospital of Wales, Cardiff, UK
Folkert W Asselbergs Institute of Health Informatics, University College London, London, UK Health Data Research UK, London, UK University College London Hospitals NIHR Biomedical Research Centre, London, UK Department of Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands Institute of Cardiovascular Science, University College London, London, UK
Steve Harris University College London Hospitals NHS Trust, London, UK
Sylvia Richardson Medical Research Council Biostatistics Unit, University of Cambridge, Cambridge, UK
Reecha Sofat Institute of Health Informatics, University College London, London, UK University College London Hospitals NIHR Biomedical Research Centre, London, UK
Richard J B Dobson Institute of Health Informatics, University College London, London, UK Health Data Research UK, London, UK Department of Biostatistics and Health Informatics, King's College London, London, UK
Aroon Hingorani Health Data Research UK, London, UK Institute of Cardiovascular Science, University College London, London, UK
Riyaz Patel Institute of Cardiovascular Science, University College London, London, UK
Jonathan Sterne Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
Amitava Banerjee Institute of Health Informatics, University College London, London, UK Barts Health NHS Trust, The Royal London Hospital, Whitechapel Rd, London, UK
Alastair K Denniston Health Data Research UK, London, UK University Hospitals Birmingham NHSFT, Birmingham, UK
Simon Ball Health Data Research UK, London, UK University Hospitals Birmingham NHSFT, Birmingham, UK
Neil J Sebire UCL Great Ormond Street Institute of Child Health, London, UK NIHR Great Ormond Street Hospital Biomedical Research Centre, London, UK
Nigam H Shah Department of Medicine, School of Medicine, Stanford University, Stanford, CA, USA
Graham R Foster Barts Liver Centre, Blizard Institute, Queen Mary University of London, London, UK
Bryan Williams University College London Hospitals NIHR Biomedical Research Centre, London, UK Institute of Cardiovascular Science, University College London, London, UK University College London Hospitals NHS Trust, London, UK
Harry Hemingway Institute of Health Informatics, University College London, London, UK Health Data Research UK, London, UK

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Correia C, Almeida N, Figueiredo PN. Guidelines in Gastroenterology: Careful Interpretation Is Essential. GE-PORTUGUESE JOURNAL OF GASTROENTEROLOGY 2021;29:240-246. [PMID: 35979247 PMCID: PMC9274816 DOI: 10.1159/000518322] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 02/06/2021] [Accepted: 06/22/2021] [Indexed: 11/23/2022]

Abstract

Introduction

Clinical practice guidelines (CPG) contain recommendations that aim to guide physicians in the diagnosis of and therapeutic approach toward patients affected by gastrointestinal (GI) pathologies. These CPG systematically combine scientific evidence and clinical judgment, culminating in recommendations that have been shown to improve patient care.

Material and Methods

European and North American guidelines published in the area of gastroenterology in 2018 and 2019 were considered for inclusion. To standardize the results, only guidelines that used GRADE as an evidence system were included. Thus, in the end, 1,233 recommendations from 29 guidelines published between 2018 and 2019 were analyzed.

Results

Of the 1,233 recommendations collected, 324 (26.3%) had a low level of evidence and 127 (10.3%) had a very low level of evidence, indicating little evidence or expert opinion. Of the 29 publications analyzed, 14 (48.3%) did not present any recommendation with a high level of evidence. Regarding the 1,233 individual recommendations expressed in these 29 publications, only 336 (27.25%) assumed a high level of evidence, with 277 (82.44%) referring to liver pathology. Of the recommendations evaluated, 77 were from North American societies and the remaining 1,156 were European recommendations. In relation to the first group, only 3 (3.9%) had a high level of evidence belonging to the Guidelines for Sedation and Anesthesia in GI Endoscopy.

Conclusions

More than 25% of all recommendations currently accepted to guide patients with gastroenterological disorders are based on low-quality evidence or expert opinion. Thus, these documents should guide our performance, but clinical sense and multidisciplinarity must not be overlooked in dubious cases and with weak scientific evidence. Research should focus on the development of randomized controlled trials and systematic reviews to improve the evidence supporting the guidelines that guide clinical practice.

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Choi DT, Davila JA, Sansgiry S, David E, Singh H, El-Serag HB, Sada YHF. Factors Associated With Delay of Diagnosis of Hepatocellular Carcinoma in Patients With Cirrhosis. Clin Gastroenterol Hepatol 2021;19:1679-1687. [PMID: 32693047 PMCID: PMC7855025 DOI: 10.1016/j.cgh.2020.07.026] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/21/2020] [Revised: 07/02/2020] [Accepted: 07/15/2020] [Indexed: 12/12/2022]

Abstract

BACKGROUND & AIMS

We examined the frequency of and factors associated with delays in diagnosis of hepatocellular carcinoma (HCC) in a cohort of patients with cirrhosis in the Veterans Health Administration.

METHODS

In a retrospective study, we collected and analyzed data from the Veterans Health Administration's electronic health records. We used a multivariate logistic regression model to identify factors associated with a delay in diagnosis of HCC of more than 60 days following a red flag (defined as the earliest date at which a diagnosis of HCC could have been made, based on American Association for the Study of Liver Disease 2005 guidelines). We used multivariate Cox proportional hazards model to evaluate the effects of delayed diagnosis on survival, adjusting for patient and provider characteristics.

RESULTS

Among 655 patients with cirrhosis and a diagnosis of HCC from 2006 through 2011, 46.9% had a delay in diagnosis of more than 60 days following a red flag for HCC. Delays in diagnosis for more than 60 days were significantly associated with lack of provider adherence to the guidelines (adjusted odds ratio [OR], 4.82; 95% CI, 3.12-7.45), a diagnostic imaging evaluation instead of only measurement of alfa fetoprotein (adjusted OR, 2.63; 95% CI, 1.09-6.24), and diagnosis as an incidental finding during examination for an unrelated medical problem (compared with an HCC-related assessment) (adjusted OR, 2.26; 95% CI, 1.09-4.67). Diagnostic delays of 60 days or more were associated with lower mortality compared to patients without a delay in diagnosis (unadjusted hazard ratio, 0.57; 95% CI, 0.47-0.68 and adjusted hazard ratio, 0.63; 95% CI, 0.50-0.78).

CONCLUSIONS

Nearly half of veterans with cirrhosis have delays in diagnosis of HCC of 60 days or more after a red flag, defined by guidelines. Interventions are needed to improve timely follow-up of red flags for HCC and adherence to guidelines, to increase early detection of HCC.

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Affiliation(s)

Debra T. Choi Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX,Section of Health Services Research, Department of Medicine, Baylor College of Medicine, Houston, TX
Jessica A. Davila Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX,Section of Health Services Research, Department of Medicine, Baylor College of Medicine, Houston, TX
Shubhada Sansgiry Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX,Veterans Affairs South Central Mental Illness Research Education and Clinical Center (MIRECC), Houston, TX,Section of Health Services Research, Department of Medicine, Baylor College of Medicine, Houston, TX
Eric David Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX
Hardeep Singh Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX,Section of Health Services Research, Department of Medicine, Baylor College of Medicine, Houston, TX
Hashem B. El-Serag Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX,Section of Gastroenterology and Hepatology, Department of Medicine, Baylor College of Medicine, Houston, TX,Section of Health Services Research, Department of Medicine, Baylor College of Medicine, Houston, TX
Yvonne Hsiao-Fan Sada Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX,Section of Gastroenterology and Hepatology, Department of Medicine, Baylor College of Medicine, Houston, TX,Section of Hematology and Oncology, Department of Medicine, Baylor College of Medicine, Houston, TX

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Symons T, Zalcberg J, Morris J. Making the move to a learning healthcare system: has the pandemic brought us one step closer? AUST HEALTH REV 2021;45:548-553. [PMID: 34289930 DOI: 10.1071/ah21076] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/09/2021] [Accepted: 05/03/2021] [Indexed: 11/23/2022]

Abstract

The notion of a learning healthcare system (LHS) is gaining traction to advance the objectives of high-quality patient-centred care. Within such a system, real-world data analysis, clinical research and health service research are core activities of the health system. To support the transition to an LHS, the Australian Government is implementing the National Clinical Trials Governance Framework, which extends health service accreditation standards to the conduct of clinical trials. This initiative encourages the integration of clinical trials into clinical care and the fostering of a culture of continuous improvement. However, implementing this initiative may prove challenging if health system leaders, clinicians and patients fail to recognise the value of clinical trials as a core health system activity. In this article we describe the enduring value of clinical trials and how the COVID-19 pandemic has enhanced their value by addressing longstanding deficiencies in the way trials are conducted. We also summarise best-practice advice on the embedding of trials into routine health care to enable their integration into health system operations. What is known about this topic? Many healthcare organisations seek to transition to a learning health system. In Australia, National Safety and Quality Health Service Standards, which support the embedding of clinical trials as a core health system activity, have been implemented to catalyse the move. What does this paper add? Because there is little practical advice on how to embed clinical trials into health system operations, this paper summarises best practice. It also provides a rationale for embedding trials as a core health system activity, because the creation of a strong research culture is an important determinant of success. What are the implications for practitioners? The successful transition to an LHS would significantly advance the goals of value-based care.

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Hai VV, Shimakawa Y, Kim J, Do Ngoc H, Le Minh Q, Laureillard D, Lemoine M. Assessment and simplification of treatment eligibility among patients with chronic hepatitis B infection in Vietnam. Clin Infect Dis 2020;73:e1072-e1077. [PMID: 33331880 DOI: 10.1093/cid/ciaa1814] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/14/2020] [Indexed: 12/30/2022] Open

Li C, Liang J, Xiang H, Chen H, Tian J. Effectiveness of direct-acting antivirals in maintenance hemodialysis patients complicated with chronic hepatitis C. Medicine (Baltimore) 2020;99:e23384. [PMID: 33235113 PMCID: PMC7710190 DOI: 10.1097/md.0000000000023384] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/03/2020] [Revised: 10/21/2020] [Accepted: 10/29/2020] [Indexed: 11/28/2022] Open

Dayton SR, Baker H, Sheth U, Tjong VK, Terry M. Various clinical practice guidelines for sports-related concussion are of sufficient methodological quality by AGREE II: a systematic review. J ISAKOS 2020. [DOI: 10.1136/jisakos-2019-000410] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/03/2022]

Desai AP, Go RS, Poonacha TK. Category of evidence and consensus underlying National Comprehensive Cancer Network guidelines: Is there evidence of progress? Int J Cancer 2020;148:429-436. [PMID: 32674225 DOI: 10.1002/ijc.33215] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/24/2020] [Revised: 07/04/2020] [Accepted: 07/10/2020] [Indexed: 11/09/2022]

Feitosa MC, Leite PHADC, Costa JH, Hökerberg YHM. [Methodological quality assessment of guidelines for surveillance and clinical management of dengue and chikungunya]. CAD SAUDE PUBLICA 2020;36:e00050919. [PMID: 32725085 DOI: 10.1590/0102-311x00050919] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/14/2019] [Accepted: 01/10/2020] [Indexed: 11/21/2022] Open

Sakai Y, Fukunishi S, Takamura M, Inoue O, Takashima S, Usui S, Seki A, Nasti A, Ho TTB, Kawaguchi K, Asai A, Tsuchimoto Y, Yamashita T, Yamashita T, Mizukoshi E, Honda M, Imai Y, Yoshimura K, Murayama T, Wada T, Harada K, Higuchi K, Kaneko S. Regenerative Therapy for Liver Cirrhosis Based on Intrahepatic Arterial Infusion of Autologous Subcutaneous Adipose Tissue-Derived Regenerative (Stem) Cells: Protocol for a Confirmatory Multicenter Uncontrolled Clinical Trial. JMIR Res Protoc 2020;9:e17904. [PMID: 32229470 PMCID: PMC7319609 DOI: 10.2196/17904] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/20/2020] [Revised: 03/02/2020] [Accepted: 03/11/2020] [Indexed: 12/17/2022] Open

Affiliation(s)

Yoshio Sakai Department of Gastroenterology, Kanazawa University Hospital, Kanazawa, Japan
Shinya Fukunishi Department of Gastroenterology, Osaka Medical College, Takatsuki, Japan
Masayuki Takamura Department of Cardiovascular Medicine, Kanazawa University Hospital, Kanazawa, Japan
Oto Inoue Department of Cardiovascular Medicine, Kanazawa University Hospital, Kanazawa, Japan
Shinichiro Takashima Department of Cardiovascular Medicine, Kanazawa University Hospital, Kanazawa, Japan
Soichiro Usui Department of Cardiovascular Medicine, Kanazawa University Hospital, Kanazawa, Japan
Akihiro Seki Department of Gastroenterology, Kanazawa University Hospital, Kanazawa, Japan
Alessandro Nasti System Biology, Kanazawa University, Kanazawa, Japan
Tuyen Thuy Bich Ho System Biology, Kanazawa University, Kanazawa, Japan
Kazunori Kawaguchi Department of Gastroenterology, Kanazawa University Hospital, Kanazawa, Japan
Akira Asai Department of Gastroenterology, Osaka Medical College, Takatsuki, Japan
Yusuke Tsuchimoto Department of Gastroenterology, Osaka Medical College, Takatsuki, Japan
Taro Yamashita Department of General Medicine, Kanazawa University Hospital, Kanazawa, Japan
Tatsuya Yamashita Department of Gastroenterology, Kanazawa University Hospital, Kanazawa, Japan
Eishiro Mizukoshi Department of Gastroenterology, Kanazawa University Hospital, Kanazawa, Japan
Masao Honda Department of Gastroenterology, Kanazawa University Hospital, Kanazawa, Japan
Yasuhito Imai Innovative Clinical Research Center, Kanazawa University, Kanazawa, Japan
Kenichi Yoshimura Innovative Clinical Research Center, Kanazawa University, Kanazawa, Japan.,Center for Integrated Medical Research, Hiroshima University Hospital, Hiroshima, Japan
Toshinori Murayama Innovative Clinical Research Center, Kanazawa University, Kanazawa, Japan
Takashi Wada Department of Nephrology, Kanazawa University Hospital, Kanazawa, Japan
Kenichi Harada Department of Human Pathology, Kanazawa University Graduate School of Medicine, Kanazawa, Japan
Kazuhide Higuchi Department of Gastroenterology, Osaka Medical College, Takatsuki, Japan
Shuichi Kaneko Department of Gastroenterology, Kanazawa University Hospital, Kanazawa, Japan.,System Biology, Kanazawa University, Kanazawa, Japan

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Levels of evidence supporting European and American community-acquired pneumonia guidelines. Eur J Clin Microbiol Infect Dis 2020;39:1159-1167. [PMID: 32030566 DOI: 10.1007/s10096-020-03833-8] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/09/2019] [Accepted: 01/26/2020] [Indexed: 02/07/2023]

Campogiani L, Tejada S, Ferreira-Coimbra J, Restrepo MI, Rello J. Evidence supporting recommendations from international guidelines on treatment, diagnosis, and prevention of HAP and VAP in adults. Eur J Clin Microbiol Infect Dis 2019;39:483-491. [PMID: 31823149 PMCID: PMC7223521 DOI: 10.1007/s10096-019-03748-z] [Citation(s) in RCA: 18] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/12/2019] [Accepted: 10/24/2019] [Indexed: 12/25/2022]

Abstract

Clinical practice guidelines (CPGs) are intended to support clinical decisions and should be based on high-quality evidence. The objective of the study was to evaluate the quality of evidence supporting the recommendations issued in CPGs for therapy, diagnosis, and prevention of hospital-acquired and ventilator-associated pneumonia (HAP/VAP). CPGs released by international scientific societies after year 2000, using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) methodology, were analyzed. Number and strength of recommendations and quality of evidence (high, moderate, low, and very low) were extracted and indexed in the aforementioned sections. High-quality evidence was based on randomized control trials (RCT) without important limitations and exceptionally on rigorous observational studies. Eighty recommendations were assessed, with 7 (8.7%), 24 (30.0%), 29 (36.3%), and 20 (25.0%) being supported by high, moderate, low, and very low-quality evidence, respectively. Highest evidence degree was reported for 26 prevention recommendations, with 7 (26.9%) supported by high-quality evidence and no recommendation based on very low-quality evidence. In contrast, among 9 recommendations for diagnosis and 45 for therapy, none was supported by high-quality evidence, in spite of being recommended as strong in 33.3% and 46.7%, respectively. Among HAP/VAP diagnosis recommendations, the majority of evidence was rated as low or very low-quality (55.6% and 22.2%, respectively) whereas among HAP/VAP therapy recommendations, 4/5 were rated as low and very low-quality (40% each). In conclusion, among HAP/VAP international guidelines, most recommendations, particularly in therapy, remain supported by observational studies, case reports, and expert opinion. Well-designed RCTs are urgently needed.

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van Dijk WB, Grobbee DE, de Vries MC, Groenwold RHH, van der Graaf R, Schuit E. A systematic breakdown of the levels of evidence supporting the European Society of Cardiology guidelines. Eur J Prev Cardiol 2019;26:1944-1952. [PMID: 31409110 PMCID: PMC6886117 DOI: 10.1177/2047487319868540] [Citation(s) in RCA: 16] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/11/2019] [Accepted: 07/18/2019] [Indexed: 11/17/2022]

Abstract

AIMS

Reviews of clinical practice guidelines have repeatedly concluded that only a minority of guideline recommendations are supported by high-quality evidence from randomised controlled trials. The aim of this study is to evaluate whether these findings apply to the whole cardiovascular evidence base or specific recommendation types and actions.

METHODS

All recommendations from current European Society of Cardiology guidelines were extracted with their class (I, treatment is beneficial; II, treatment is possibly beneficial; III, treatment is harmful) and level of evidence (A, multiple randomised controlled trials/meta-analyses; B, single randomised controlled trials/large observational studies; C, expert opinion/small studies). Recommendations were categorised by type (therapeutic, diagnostic, other) and actions (e.g. pharmaceutical intervention/non-invasive imaging/test).

RESULTS

In total, 3531 recommendations (median 128, interquartile range 108-150) were extracted from 27 guidelines. Therapeutic recommendations comprised 2545 (72.1%) recommendations, 411 (16.1%) were supported by level of evidence A, 833 (32.7%) by B and 1301 (51.1%) by C. Class I/III (should/should not) recommendations on minimally invasive interventions were most supported by level of evidence A (55/183, 30.1%) (B [70/183, 38.3%], C [58/183, 31.7%]), while class I/III recommendations on open surgical interventions were least supported by level of evidence A (15/164, 9.1%) (B [34/164, 20.7%], C [115/164, 70.1%]). Of all (831, 23.5%) diagnostic recommendations, just 44/503 (8.7%) class I/III recommendations were supported by level of evidence A (B (125/503, 24.9%), C (334/503, 66.4%)).

CONCLUSION

Evidence levels supporting European Society of Cardiology guideline recommendations differ widely between recommendation types and actions. Attributing to this variability are different evidence requirements, therapeutic/diagnostic recommendations, different feasibility levels for trials (e.g. open surgical/pharmacological) and many off-topic/policy recommendations based on expert opinion.

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Fanaroff AC, Califf RM, Windecker S, Smith SC, Lopes RD. Levels of Evidence Supporting American College of Cardiology/American Heart Association and European Society of Cardiology Guidelines, 2008-2018. JAMA 2019;321:1069-1080. [PMID: 30874755 PMCID: PMC6439920 DOI: 10.1001/jama.2019.1122] [Citation(s) in RCA: 153] [Impact Index Per Article: 25.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/20/2018] [Accepted: 02/12/2019] [Indexed: 12/24/2022]

Abstract

Importance

Clinical decisions are ideally based on evidence generated from multiple randomized controlled trials (RCTs) evaluating clinical outcomes, but historically, few clinical guideline recommendations have been based entirely on this type of evidence.

Objective

To determine the class and level of evidence (LOE) supporting current major cardiovascular society guideline recommendations, and changes in LOE over time.

Data Sources

Current American College of Cardiology/American Heart Association (ACC/AHA) and European Society of Cardiology (ESC) clinical guideline documents (2008-2018), as identified on cardiovascular society websites, and immediate predecessors to these guideline documents (1999-2014), as referenced in current guideline documents.

Study Selection

Comprehensive guideline documents including recommendations organized by class and LOE.

Data Extraction and Synthesis

The number of recommendations and the distribution of LOE (A [supported by data from multiple RCTs or a single, large RCT], B [supported by data from observational studies or a single RCT], and C [supported by expert opinion only]) were determined for each guideline document.

Main Outcomes and Measures

The proportion of guideline recommendations supported by evidence from multiple RCTs (LOE A).

Results

Across 26 current ACC/AHA guidelines (2930 recommendations; median, 121 recommendations per guideline [25th-75th percentiles, 76-155]), 248 recommendations (8.5%) were classified as LOE A, 1465 (50.0%) as LOE B, and 1217 (41.5%) as LOE C. The median proportion of LOE A recommendations was 7.9% (25th-75th percentiles, 0.9%-15.2%). Across 25 current ESC guideline documents (3399 recommendations; median, 130 recommendations per guideline [25th-75th percentiles, 111-154]), 484 recommendations (14.2%) were classified as LOE A, 1053 (31.0%) as LOE B, and 1862 (54.8%) as LOE C. When comparing current guidelines with prior versions, the proportion of recommendations that were LOE A did not increase in either ACC/AHA (median, 9.0% [current] vs 11.7% [prior]) or ESC guidelines (median, 15.1% [current] vs 17.6% [prior]).

Conclusions and Relevance

Among recommendations in major cardiovascular society guidelines, only a small percentage were supported by evidence from multiple RCTs or a single, large RCT. This pattern does not appear to have meaningfully improved from 2008 to 2018.

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Hasegawa K, Nishikawa H, Enomoto H, Iwata Y, Sakai Y, Ikeda N, Takashima T, Aizawa N, Takata R, Yoh K, Ishii N, Yuri Y, Nishimura T, Iijima H, Hatano E, Fujimoto J, Nishiguchi S. Proposed model for the prediction of intrahepatic covalently closed circular DNA level in patients with chronic hepatitis B. Hepatol Res 2019;49:271-283. [PMID: 30358027 DOI: 10.1111/hepr.13280] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/06/2018] [Revised: 10/04/2018] [Accepted: 10/19/2018] [Indexed: 02/08/2023]

Abstract

AIM

We sought to create a prediction model for intrahepatic covalently closed circular DNA (IH-cccDNA) level in chronic hepatitis B (CHB) patients and to validate the model's predictive accuracy.

METHODS

Patients who did not receive previous nucleoside analogue (NA) therapy were assigned to the training cohort (n = 57), and those who received previous NA therapy were assigned to the validation cohort (n = 69). Factors linked to IH-cccDNA levels in the training cohort were analyzed and a formula to predict IH-cccDNA levels was constructed. Next, the reproducibility of that formula was assessed.

RESULTS

In the multivariate analysis for the prediction of IH-cccDNA level in the training cohort, fasting blood sugar (FBS) (P = 0.0227), hepatitis B e antigen (HBeAg) (P = 0.0067) and log10 (HB surface antigen [HBsAg]) (P = 0.0497) were significant, whereas HB core-related antigen (HBcrAg) tended to be significant (P = 0.0562). The formula was constructed and named the FBS-cres score based on the variables used (FBS, HBcrAg, HBeAg, and HBsAg). The FBS-cres score was calculated as: 3.1686 - (0.0148 × FBS) + (0.1982 × HBcrAg) + (0.0008168 × HBeAg) + (0.1761 × log10 (HBsAg)). In the training cohort, a significant correlation was noted between HBcrAg and IH-cccDNA levels (P < 0.0001, r = 0.67), whereas the FBS-cres score was more closely correlated to IH-cccDNA level (P < 0.0001, r = 0.81). In the validation cohort, significant correlation was found between HBcrAg and IH-cccDNA levels (P = 0.0012, r = 0.38), whereas the FBS-cres score was more closely linked to IH-cccDNA levels (P < 0.0001, r = 0.51). Similar tendencies were observed in all subgroup analyses.

CONCLUSION

Our proposed model for the prediction of IH-cccDNA level could be helpful in CHB patients.

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Affiliation(s)

Kunihiro Hasegawa Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
Hiroki Nishikawa Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
Hirayuki Enomoto Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
Yoshinori Iwata Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
Yoshiyuki Sakai Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
Naoto Ikeda Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
Tomoyuki Takashima Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
Nobuhiro Aizawa Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
Ryo Takata Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
Kazunori Yoh Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
Noriko Ishii Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
Yukihisa Yuri Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
Takashi Nishimura Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
Hiroko Iijima Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
Etsuro Hatano Division of Hepatobiliary and Pancreatic disease, Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan
Jiro Fujimoto Division of Hepatobiliary and Pancreatic disease, Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan
Shuhei Nishiguchi Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan

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Kim BG, Park NH, Lee SB, Lee H, Lee BU, Park JH, Jung SW, Jeong ID, Bang SJ, Shin JW. Mortality, liver transplantation and hepatic complications in patients with treatment-naïve chronic hepatitis B treated with entecavir vs tenofovir. J Viral Hepat 2018;25:1565-1575. [PMID: 29998592 DOI: 10.1111/jvh.12971] [Citation(s) in RCA: 51] [Impact Index Per Article: 7.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/05/2018] [Revised: 06/02/2018] [Accepted: 06/07/2018] [Indexed: 12/12/2022]

Meyer C, Bowers A, Wayant C, Checketts J, Scott J, Musuvathy S, Vassar M. Scientific evidence underlying the American College of Gastroenterology's clinical practice guidelines. PLoS One 2018;13:e0204720. [PMID: 30281671 PMCID: PMC6169920 DOI: 10.1371/journal.pone.0204720] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/11/2017] [Accepted: 09/13/2018] [Indexed: 12/22/2022] Open

Liu Y, Huang W, He M, Lian H, Guo Y, Huang J, Zhou J, Zhu K. Efficacy and Safety of CalliSpheres^® Drug-Eluting Beads Transarterial Chemoembolization in Barcelona Clinic Liver Cancer Stage C Patients. Oncol Res 2018;27:565-573. [PMID: 30005719 PMCID: PMC7848450 DOI: 10.3727/096504018x15313896322888] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022] Open

Béguelin C, Fall F, Seydi M, Wandeler G. The current situation and challenges of screening for and treating hepatitis B in sub-Saharan Africa. Expert Rev Gastroenterol Hepatol 2018;12:537-546. [PMID: 29737218 DOI: 10.1080/17474124.2018.1474097] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]

Xiang X, You XM, Li LQ. Expression of HSP90AA1/HSPA8 in hepatocellular carcinoma patients with depression. Onco Targets Ther 2018;11:3013-3023. [PMID: 29872313 PMCID: PMC5973353 DOI: 10.2147/ott.s159432] [Citation(s) in RCA: 40] [Impact Index Per Article: 5.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/27/2023] Open

Colbeck M, Lockwood C, Peters M, Fulbrook P, McCabe D. The effect of evidence-based, treatment-oriented, clinical practice guidelines on improving patient care outcomes: a systematic review protocol. ACTA ACUST UNITED AC 2018;14:42-51. [PMID: 27532648 DOI: 10.11124/jbisrir-2016-002515] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/31/2022]

Li S, Yang Y, Ding X, Yang M, She S, Peng H, Xu X, Ran X, Li S, Hu P, Hu H, Zhang D, Ren H. LHBs can elevate the expression of MDR1 through HIF-1α in patients with CHB infection: a comparative proteomic study. Oncotarget 2018;8:4549-4562. [PMID: 27999186 PMCID: PMC5354853 DOI: 10.18632/oncotarget.13941] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/26/2016] [Accepted: 12/05/2016] [Indexed: 12/18/2022] Open

Affiliation(s)

Shiying Li Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Institute for Viral Hepatitis, Department of Infectious Diseases, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, PR China
Yixuan Yang Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Institute for Viral Hepatitis, Department of Infectious Diseases, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, PR China
Xiangchun Ding Department of Infectious Diseases, General Hospital of Ningxia Medical University, Yinchuan, Ningxia, PR China
Min Yang Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Institute for Viral Hepatitis, Department of Infectious Diseases, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, PR China
Sha She Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Institute for Viral Hepatitis, Department of Infectious Diseases, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, PR China
Hong Peng Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Institute for Viral Hepatitis, Department of Infectious Diseases, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, PR China
Xiaoming Xu Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Institute for Viral Hepatitis, Department of Infectious Diseases, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, PR China
Xiaoping Ran Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Institute for Viral Hepatitis, Department of Infectious Diseases, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, PR China
Sanglin Li Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Institute for Viral Hepatitis, Department of Infectious Diseases, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, PR China
Peng Hu Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Institute for Viral Hepatitis, Department of Infectious Diseases, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, PR China
Huaidong Hu Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Institute for Viral Hepatitis, Department of Infectious Diseases, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, PR China
Dazhi Zhang Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Institute for Viral Hepatitis, Department of Infectious Diseases, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, PR China
Hong Ren Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Institute for Viral Hepatitis, Department of Infectious Diseases, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, PR China

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Chen CY, Tien FM, Cheng A, Huang SY, Chou WC, Yao M, Tang JL, Tien HF, Sheng WH. Hepatitis B reactivation among 1962 patients with hematological malignancy in Taiwan. BMC Gastroenterol 2018;18:6. [PMID: 29310589 PMCID: PMC5759199 DOI: 10.1186/s12876-017-0735-1] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/21/2016] [Accepted: 12/22/2017] [Indexed: 01/29/2023] Open

Abstract

BACKGROUND

The risk of Hepatitis B virus (HBV) reactivation in patients with different hematological malignancy except lymphoma were rarely known before.

METHODS

A total of 1962 patients with hematological malignancy were enrolled and followed-up at the National Taiwan University Hospital between 2008 and 2013. The clinical characteristics, HBV serology, and laboratory data were retrospectively reviewed and analyzed.

RESULTS

A total of 1962 patients comprising 1048 men and 914 women were studied. The median age of the patients was 55 years (range, 15-97 years). Chronic HBV carriage was documented at diagnosis of hematological malignancy in 286 (14.6%) patients. A total of 171 (59.8%) of the 286 HBV carriers received primary prophylaxis with anti-HBV agents. Of the HBV carriers, 97 (33.9%) developed hepatitis B reactivation during or after chemotherapy, including 59 patients who had discontinued antiviral therapy. The incidence of hepatitis B reactivation among patients with hematological malignancy and HBV carriage was 10.4 per 100 person-years. A multivariate analysis revealed hepatocellular carcinoma (p < 0.001) and antiviral prophylaxis use (p < 0.001) were independent risk factors of HBV reactivation in HBV carriers. Of the 1676 patients with initial negative hepatitis B surface antigen (HBsAg) counts, 41 (2.4%) experienced hepatitis B reactivation, reverse seroconversion of HBsAg, and lost their protective hepatitis B surface antibody (anti-HBs). A multivariate analysis revealed that diabetes mellitus (p = 0.005, odds ratio (OR): 0.218, 95% confidence interval (CI): 0.076-0.629), allogeneic transplantation (p = 0.013, OR: 0.182, 95% CI: 0.047-0.701), liver cirrhosis (p < 0.001, OR: 0.002, 95% CI: 0-0.047), low anti-HBs titers (p = 0.016, OR: 0.020, 95% CI: 0.001-0.480), and positive hepatitis B core antibody (p = 0.013, OR: 0.070, 95% CI: 0.009-0.571) were independent risk factors of positive seroconversion of HBsAg in patients with hematological malignancy.

CONCLUSIONS

The incidence of HBV reactivation among the patients with varying subtypes of hematological malignancy is similar. Prophylaxis with anti-HBV agents critically reduced the risk of hepatitis B reactivation.

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Bakel LA, Hamid J, Ewusie J, Liu K, Mussa J, Straus S, Parkin P, Cohen E. International Variation in Asthma and Bronchiolitis Guidelines. Pediatrics 2017;140:peds.2017-0092. [PMID: 29070533 DOI: 10.1542/peds.2017-0092] [Citation(s) in RCA: 21] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 08/16/2017] [Indexed: 11/24/2022] Open

Weinfurt KP, Hernandez AF, Coronado GD, DeBar LL, Dember LM, Green BB, Heagerty PJ, Huang SS, James KT, Jarvik JG, Larson EB, Mor V, Platt R, Rosenthal GE, Septimus EJ, Simon GE, Staman KL, Sugarman J, Vazquez M, Zatzick D, Curtis LH. Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory. BMC Med Res Methodol 2017;17:144. [PMID: 28923013 PMCID: PMC5604499 DOI: 10.1186/s12874-017-0420-7] [Citation(s) in RCA: 131] [Impact Index Per Article: 16.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/26/2017] [Accepted: 08/31/2017] [Indexed: 12/20/2022] Open

Abstract

BACKGROUND

The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care. The emergence of pragmatic clinical trials (PCTs) poses a possible solution: these large-scale trials are embedded within routine clinical care and often involve cluster randomization of hospitals, clinics, primary care providers, etc. Interventions can be implemented by health system personnel through usual communication channels and quality improvement infrastructure, and data collected as part of routine clinical care. However, experience with these trials is nascent and best practices regarding design operational, analytic, and reporting methodologies are undeveloped.

METHODS

To strengthen the national capacity to implement cost-effective, large-scale PCTs, the Common Fund of the National Institutes of Health created the Health Care Systems Research Collaboratory (Collaboratory) to support the design, execution, and dissemination of a series of demonstration projects using a pragmatic research design.

RESULTS

In this article, we will describe the Collaboratory, highlight some of the challenges encountered and solutions developed thus far, and discuss remaining barriers and opportunities for large-scale evidence generation using PCTs.

CONCLUSION

A planning phase is critical, and even with careful planning, new challenges arise during execution; comparisons between arms can be complicated by unanticipated changes. Early and ongoing engagement with both health care system leaders and front-line clinicians is critical for success. There is also marked uncertainty when applying existing ethical and regulatory frameworks to PCTS, and using existing electronic health records for data capture adds complexity.

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Affiliation(s)

Kevin P. Weinfurt Department of Population Health Sciences, Duke University School of Medicine, 220 W Main St., Suite 720A, Durham, NC 27705 USA Duke Clinical Research Institute, 2400 Pratt St., Durham, NC 27710 USA Department of Psychology and Neuroscience, Duke Clinical Research Institute, Durham, NC 27710 USA
Adrian F. Hernandez Duke Clinical Research Institute, 2400 Pratt St., Durham, NC 27710 USA Duke University School of Medicine, 3115 N. Duke Street, Durham, NC 27704 USA
Gloria D. Coronado Kaiser Permanente Center for Health Research, 3800 N. Interstate Avenue, Portland, OR 97227-1098 USA
Lynn L. DeBar Kaiser Permanente Center for Health Research, 3800 N. Interstate Avenue, Portland, OR 97227-1098 USA
Laura M. Dember Perelman School of MedicineBlockley Hall, Office 920, 423 Guardian Drive, Philadelphia, PA 19104 USA
Beverly B. Green Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Suite 1600, Seattle, WA 98101-1466 USA
Patrick J. Heagerty University of Washington, 325 Ninth Ave, Box 359728, Seattle, WA 98104-2499 USA
Susan S. Huang University of California Irvine School of Medicine, 101 The City Drive South, City Tower, Suite 400, Mail Code: 4081, Orange, CA 92868 USA
Kathryn T. James University of Washington, 325 Ninth Ave, Box 359728, Seattle, WA 98104-2499 USA
Jeffrey G. Jarvik University of Washington, 325 Ninth Ave, Box 359728, Seattle, WA 98104-2499 USA
Eric B. Larson Group Health Research Institute, 1730 Minor Ave, Suite 1600, Seattle, WA 98101-1466 USA
Vincent Mor Department of Community Health, Brown University, Box G-S121-2, Providence, RI 02912 USA
Richard Platt Department of Population Medicine, Harvard Pilgrim Health Care Institute, 401 Park Drive, Suite 401 East, Boston, MA 02215 USA
Gary E. Rosenthal Department of Internal Medicine, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157 USA
Edward J. Septimus Hospital Corporation of America Nashville TN, AND Texas A&M College of Medicine, One Park Plaza, Nashville, TN 37203 USA
Gregory E. Simon Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Suite 1600, Seattle, WA 98101-1466 USA
Karen L. Staman CHB Wordsmith, Inc., 22 Bagwell Ave, Raleigh, NC 27607 USA
Jeremy Sugarman Johns Hopkins Berman Institute of Bioethics, 1809 Ashland Ave., Room 203, Baltimore, MD 21205 USA
Miguel Vazquez University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390-8856 USA
Douglas Zatzick University of Washington School of Medicine, 325 9th Ave, Seattle, WA 98104 USA
Lesley H. Curtis Duke Clinical Research Institute, 2400 Pratt St., Durham, NC 27710 USA Duke University School of Medicine, 3115 N. Duke Street, Durham, NC 27704 USA

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Pincus D, Kuhn JE, Sheth U, Rizzone K, Colbenson K, Dwyer T, Karpinos A, Marks PH, Wasserstein D. A Systematic Review and Appraisal of Clinical Practice Guidelines for Musculoskeletal Soft Tissue Injuries and Conditions. Am J Sports Med 2017;45:1458-1464. [PMID: 28298051 DOI: 10.1177/0363546516667903] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/31/2023]

Abstract

BACKGROUND

Clinical practice guidelines (CPGs) are published by several sports medicine institutions. A systematic evaluation can help identify the highest quality CPGs for clinical use and identify any deficiencies that remain.

PURPOSE

To identify and appraise CPGs relevant to clinical sports medicine professionals.

STUDY DESIGN

Systematic review.

METHODS

Predetermined selection criteria were utilized by 2 reviewers who independently identified published CPGs before January 1, 2014. CPGs were excluded if they focused on injured workers, radiological criteria, medical pathology, or the axial skeleton (back/neck). The remaining guidelines were scored by 6 reviewers with different clinical backgrounds using the Appraisal of Guidelines for Research and Evaluation II (AGREE II). Scores lower than 50% indicated deficiency. Scores were also stratified by the publishing institution and anatomic location and compared using Kruskal-Wallis tests. The Spearman correlation coefficient was used to assess the range of interobserver agreement between the evaluators.

RESULTS

Seventeen CPGs met the inclusion criteria. The majority of guidelines pertained to the knee, ankle, or shoulder. Interobserver agreement was strong ( r = 0.548-0.740), and mean total scores between nonsurgical (107.8) and surgical evaluators (109.3) were not statistically different. Overall guideline quality was variable but not deficient for 16 of 17 guidelines (>50%), except regarding clinical "applicability" and "editorial independence." No difference was found between CPGs of the knee, shoulder, foot/ankle, or chronic conditions. However, CPG publishing institutions had significantly different scores; the American Academy of Orthopaedic Surgeons (AAOS) guidelines scored significantly higher (141.4) than the total mean score (108.0).

CONCLUSION

The overall quality of sports medicine CPGs was variable but generally not deficient, except regarding applicability and editorial independence. Bias through poor editorial independence is a concern. To improve future guideline quality, authors should pay particular attention to these areas and use existing highest quality guidelines, or the AGREE II instrument, as templates. CPGs dedicated to anatomic areas other than the knee, ankle, and shoulder are needed.

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Hoffmann-Eßer W, Siering U, Neugebauer EAM, Brockhaus AC, Lampert U, Eikermann M. Guideline appraisal with AGREE II: Systematic review of the current evidence on how users handle the 2 overall assessments. PLoS One 2017;12:e0174831. [PMID: 28358870 PMCID: PMC5373625 DOI: 10.1371/journal.pone.0174831] [Citation(s) in RCA: 80] [Impact Index Per Article: 10.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/12/2016] [Accepted: 03/15/2017] [Indexed: 11/19/2022] Open

Abstract

INTRODUCTION

The Appraisal of Guidelines for Research & Evaluation (AGREE) II instrument is the most commonly used guideline appraisal tool. It includes 23 appraisal criteria (items) organized within 6 domains and 2 overall assessments (1. overall guideline quality; 2. recommendation for use). The aim of this systematic review was twofold. Firstly, to investigate how often AGREE II users conduct the 2 overall assessments. Secondly, to investigate the influence of the 6 domain scores on each of the 2 overall assessments.

MATERIALS AND METHODS

A systematic bibliographic search was conducted for publications reporting guideline appraisals with AGREE II. The impact of the 6 domain scores on the overall assessment of guideline quality was examined using a multiple linear regression model. Their impact on the recommendation for use (possible answers: "yes", "yes, with modifications", "no") was examined using a multinomial regression model.

RESULTS

118 relevant publications including 1453 guidelines were identified. 77.1% of the publications reported results for at least one overall assessment, but only 32.2% reported results for both overall assessments. The results of the regression analyses showed a statistically significant influence of all domains on overall guideline quality, with Domain 3 (rigour of development) having the strongest influence. For the recommendation for use, the results showed a significant influence of Domains 3 to 5 ("yes" vs. "no") and Domains 3 and 5 ("yes, with modifications" vs. "no").

CONCLUSIONS

The 2 overall assessments of AGREE II are underreported by guideline assessors. Domains 3 and 5 have the strongest influence on the results of the 2 overall assessments, while the other domains have a varying influence. Within a normative approach, our findings could be used as guidance for weighting individual domains in AGREE II to make the overall assessments more objective. Alternatively, a stronger content analysis of the individual domains could clarify their importance in terms of guideline quality. Moreover, AGREE II should require users to transparently present how they conducted the assessments.

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Nishikawa H, Nishijima N, Enomoto H, Sakamoto A, Nasu A, Komekado H, Nishimura T, Kita R, Kimura T, Iijima H, Nishiguchi S, Osaki Y. Comparison of FIB-4 index and aspartate aminotransferase to platelet ratio index on carcinogenesis in chronic hepatitis B treated with entecavir. J Cancer 2017;8:152-161. [PMID: 28243319 PMCID: PMC5327364 DOI: 10.7150/jca.16523] [Citation(s) in RCA: 27] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/18/2016] [Accepted: 09/19/2016] [Indexed: 12/25/2022] Open

Wang J, Mao Y, Liu Y, Chen Z, Chen M, Lao X, Li S. Hepatocellular Carcinoma in Children and Adolescents: Clinical Characteristics and Treatment. J Gastrointest Surg 2017;21:1128-1135. [PMID: 28397025 PMCID: PMC5486687 DOI: 10.1007/s11605-017-3420-3] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/10/2017] [Accepted: 03/30/2017] [Indexed: 02/07/2023]

Affiliation(s)

Juncheng Wang 0000 0001 2360 039Xgrid.12981.33Department of Hepatobiliary Oncology, State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, No. 651 Dongfeng Road East, Guangzhou, 510060 China
Yize Mao 0000 0001 2360 039Xgrid.12981.33Department of Hepatobiliary Oncology, State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, No. 651 Dongfeng Road East, Guangzhou, 510060 China
Yongcheng Liu 0000 0001 2360 039Xgrid.12981.33Department of Hepatobiliary Oncology, State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, No. 651 Dongfeng Road East, Guangzhou, 510060 China ,20000 0004 1759 700Xgrid.13402.34Department of Surgical Oncology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, 310020 China
Zhenxin Chen 0000 0001 2360 039Xgrid.12981.33Department of Hepatobiliary Oncology, State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, No. 651 Dongfeng Road East, Guangzhou, 510060 China
Minshan Chen 0000 0001 2360 039Xgrid.12981.33Department of Hepatobiliary Oncology, State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, No. 651 Dongfeng Road East, Guangzhou, 510060 China
Xiangming Lao 0000 0001 2360 039Xgrid.12981.33Department of Hepatobiliary Oncology, State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, No. 651 Dongfeng Road East, Guangzhou, 510060 China
Shengping Li 0000 0001 2360 039Xgrid.12981.33Department of Hepatobiliary Oncology, State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, No. 651 Dongfeng Road East, Guangzhou, 510060 China

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Cong WM, Bu H, Chen J, Dong H, Zhu YY, Feng LH, Chen J, Committee G. Practice guidelines for the pathological diagnosis of primary liver cancer: 2015 update. World J Gastroenterol 2016;22:9279-9287. [PMID: 27895416 PMCID: PMC5107692 DOI: 10.3748/wjg.v22.i42.9279] [Citation(s) in RCA: 280] [Impact Index Per Article: 31.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/01/2016] [Revised: 06/15/2016] [Accepted: 08/08/2016] [Indexed: 02/06/2023] Open

Abstract

In 2010, a panel of Chinese pathologists reported the first expert consensus for the pathological diagnosis of primary liver cancers to address the many contradictions and inconsistencies in the pathological characteristics and diagnostic criteria for PLC. Since then considerable clinicopathological studies have been conducted globally, prompting us to update the practice guidelines for the pathological diagnosis of PLC. In April 18, 2014, a Guideline Committee consisting of 40 specialists from seven Chinese Societies (including Chinese Society of Liver Cancer, Chinese Anti-Cancer Association; Liver Cancer Study Group, Chinese Society of Hepatology, Chinese Medical Association; Chinese Society of Pathology, Chinese Anti-Cancer Association; Digestive Disease Group, Chinese Society of Pathology, Chinese Medical Association; Chinese Society of Surgery, Chinese Medical Association; Chinese Society of Clinical Oncology, Chinese Anti-Cancer Association; Pathological Group of Hepatobiliary Tumor and Liver Transplantation, Chinese Society of Pathology, Chinese Medical Association) was created for the formulation of the first guidelines for the standardization of the pathological diagnosis of PLC, mainly focusing on the following topics: gross specimen sampling, concepts and diagnostic criteria of small hepatocellular carcinoma (SHCC), microvascular invasion (MVI), satellite nodules, and immunohistochemical and molecular diagnosis. The present updated guidelines are reflective of current clinicopathological studies, and include a novel 7-point baseline sampling protocol, which stipulate that at least four tissue specimens should be sampled at the junction of the tumor and adjacent liver tissues in a 1:1 ratio at the 12, 3, 6 and 9 o’clock reference positions. For the purposes of molecular pathological examination, at least one specimen should be sampled at the intratumoral zone, but more specimens should be sampled for tumors harboring different textures or colors. Specimens should be sampled at both adjacent and distant peritumoral liver tissues or the tumor margin in order to observe MVI, satellite nodules and dysplastic foci/nodules distributed throughout the background liver tissues. Complete sampling of whole SHCC ≤ 3 cm should be performed to assess its biological behavior, and in clinical practice, therapeutic borders should be also preserved, even in SHCC. The diagnostic criteria of MVI and satellite nodules, immunohistochemical panels, as well as molecular diagnostic principles, such as clonal typing, for recurrent HCC and multinodule HCC were also proposed and recommended. The standardized process of pathological examination is aimed at ensuring the accuracy of pathological PLC diagnoses as well as providing a valuable frame of reference for the clinical assessment of tumor invasive potential, the risk of postoperative recurrence, long-term survival, and the development of individualized treatment regimens. The updated guidelines could ensure the accuracy of pathological diagnoses of PLC, and provide a valuable frame of reference for its clinical assessment.

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Nishikawa H, Nishijima N, Enomoto H, Sakamoto A, Nasu A, Komekado H, Nishimura T, Kita R, Kimura T, Iijima H, Nishiguchi S, Osaki Y. A predictive model for carcinogenesis in patients with chronic hepatitis B undergoing entecavir therapy and its validation. Medicine (Baltimore) 2016;95:e4832. [PMID: 27603400 PMCID: PMC5023923 DOI: 10.1097/md.0000000000004832] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/01/2016] [Revised: 07/27/2016] [Accepted: 08/16/2016] [Indexed: 02/07/2023] Open

Abstract

We created a model to predict the development of liver carcinogenesis in patients with chronic hepatitis B (CHB) undergoing entecavir (ETV) therapy and to validate the accuracy using an independent dataset.A total of 328 CHB subjects were analyzed. Subjects were randomly assigned into 2 groups: the training group (n = 164) and the validation group (n = 164). Using data from the training group, we built a predictive model for liver carcinogenesis by performing univariate and multivariate analyses using variables associated with liver carcinogenesis. We subsequently assessed the applicability of the constructed model in the validation group.The median (range) follow-up periods in the training and the validation groups were 5.03 years (1.03-9.98) and 4.84 years (1.10-9.97), respectively. The proportion of hepatitis B virus-DNA at 24 weeks <1.9 log IU/mL in the training group was 70.7% (116/164), while that in the validation group was 71.3% (117/164). For the entire cohort (n = 328), the median alpha-fetoprotein (AFP) value at 24 weeks (3.45 ng/mL; range, 0.9-102.7 ng/mL) significantly decreased compared to the baseline values (5.55 ng/mL; range, 0.9-1039.5 ng/mL), while the median alanine aminotransferase (ALT) value at 24 weeks (24 IU/mL; range, 6-251 IU/mL) also significantly decreased compared to baseline values (57 IU/mL; range, 7-1450 IU/mL). During the observation period, hepatocellular carcinoma (HCC) developed in 15 (9.1%) patients in the training group and in 17 (10.4%) patients in the validation group. The 3- and 5-year cumulative HCC incidence rates in the entire cohort were 4.48% and 9.52%, respectively. In the multivariate analysis of the training group, age ≥54 years (P = 0.0273), ALT level at 24 weeks (P = 0.0456), and AFP at 24 weeks (P = 0.0485) were found to be significant predictors linked to HCC. Using these independent predictors, the risk for HCC development was well stratified in the validation group (overall significance, P < 0.0001). Similar results were observed in subgroup analyses of patients with or without cirrhosis and HBe antigen positivity.In conclusion, our predictive model was well verified; hence, it may be a promising model for the prediction of the development of liver carcinogenesis in CHB patients undergoing ETV therapy.

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Lemoine M, Shimakawa Y, Njie R, Taal M, Ndow G, Chemin I, Ghosh S, Njai HF, Jeng A, Sow A, Toure-Kane C, Mboup S, Suso P, Tamba S, Jatta A, Sarr L, Kambi A, Stanger W, Nayagam S, Howell J, Mpabanzi L, Nyan O, Corrah T, Whittle H, Taylor-Robinson SD, D'Alessandro U, Mendy M, Thursz MR. Acceptability and feasibility of a screen-and-treat programme for hepatitis B virus infection in The Gambia: the Prevention of Liver Fibrosis and Cancer in Africa (PROLIFICA) study. Lancet Glob Health 2016;4:e559-e567. [PMID: 27443781 DOI: 10.1016/s2214-109x(16)30130-9] [Citation(s) in RCA: 128] [Impact Index Per Article: 14.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/04/2015] [Revised: 05/05/2016] [Accepted: 06/07/2016] [Indexed: 12/30/2022]

Abstract

BACKGROUND

Despite the introduction of immunisation for hepatitis B virus (HBV) in the 1990s, HBV-related morbidity and mortality remain high in sub-Saharan Africa. Identification and treatment of asymptomatic people with chronic HBV infection should reduce the disease burden. We therefore assessed the feasibility of a screen-and-treat programme for HBV infection in The Gambia, west Africa, and estimated the proportion of HBV-infected people who had significant liver disease in need of treatment.

METHODS

Between Dec 7, 2011, and Jan 24, 2014, individuals living in randomly selected communities in western Gambia were offered hepatitis B surface antigen (HBsAg) screening via a point-of-care test. The test was also offered to potential blood donors attending the central hospital in the capital, Banjul. HBsAg-positive individuals were invited for a comprehensive liver assessment and were offered treatment according to international guidelines. We defined linkage to care as visiting the liver clinic at least once. Eligibility for treatment was judged in accordance with the 2012 European Association for the Study of the Liver guidelines.

FINDINGS

HBsAg screening was accepted by 5980 (weighted estimate 68·9%, 95% CI 65·0-72·4) of 8170 adults from 27 rural and 27 urban communities and 5559 (81·4%, 80·4-82·3) of 6832 blood donors. HBsAg was detected in 495 (8·8%, 7·9-9·7) individuals in communities and 721 (13·0%, 12·1-13·9) blood donors. Prevalence was higher in men (239 [10·5%, 8·9-12·1] of 2328 men vs 256 [7·6%, 6·5-8·7] of 3652 women; p=0·004) and middle-aged participants. Linkage to care was high in the communities, with 402 (81·3%) of 495 HBsAg-positive individuals attending the clinic. However, only 300 (41·6%) of 721 HBsAg-positive people screened at the blood bank linked into care. Of those who attended the clinic, 18 (4·4%, 2·5-7·7) patients from the communities and 29 (9·7%, 6·8-13·6) from the blood bank were eligible for treatment. Male sex was strongly associated with treatment eligibility (odds ratio 4·35, 1·50-12·58; p=0·007).

INTERPRETATION

HBV infection remains highly prevalent in The Gambia. The high coverage of community-based screening, good linkage into care, and the small proportion of HBsAg carriers who need treatment suggest that large-scale screening and treatment programmes are feasible in sub-Saharan Africa.

FUNDING

European Commission (FP7).

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Affiliation(s)

Maud Lemoine Medical Research Council Laboratories, The Gambia Unit, Fajara, The Gambia; Division of Digestive Diseases, St Mary's Hospital, Imperial College London, London, UK
Yusuke Shimakawa Medical Research Council Laboratories, The Gambia Unit, Fajara, The Gambia; Unité d'Épidémiologie des Maladies Émergentes, Institut Pasteur, Paris, France
Ramou Njie International Agency for Research on Cancer (IARC), Lyon, France
Makie Taal Ministry of Health and Social Welfare, Banjul, The Gambia
Gibril Ndow Medical Research Council Laboratories, The Gambia Unit, Fajara, The Gambia; Division of Digestive Diseases, St Mary's Hospital, Imperial College London, London, UK
Isabelle Chemin INSERM U1052, CNRS UMR5286, Centre de Recherche en Cancérologie, Université Claude Bernard, Lyon, France
Sumantra Ghosh INSERM U1052, CNRS UMR5286, Centre de Recherche en Cancérologie, Université Claude Bernard, Lyon, France
Harr F Njai Medical Research Council Laboratories, The Gambia Unit, Fajara, The Gambia
Adam Jeng Medical Research Council Laboratories, The Gambia Unit, Fajara, The Gambia
Amina Sow Department of bacteriology and Virology, CHU Le Dantec, Dakar, Senegal
Coumba Toure-Kane Department of bacteriology and Virology, CHU Le Dantec, Dakar, Senegal
Souleymane Mboup Department of bacteriology and Virology, CHU Le Dantec, Dakar, Senegal
Penda Suso Medical Research Council Laboratories, The Gambia Unit, Fajara, The Gambia
Saydiba Tamba Medical Research Council Laboratories, The Gambia Unit, Fajara, The Gambia
Abdullah Jatta Medical Research Council Laboratories, The Gambia Unit, Fajara, The Gambia
Louise Sarr Medical Research Council Laboratories, The Gambia Unit, Fajara, The Gambia
Aboubacar Kambi Medical Research Council Laboratories, The Gambia Unit, Fajara, The Gambia
William Stanger Division of Digestive Diseases, St Mary's Hospital, Imperial College London, London, UK
Shevanthi Nayagam Division of Digestive Diseases, St Mary's Hospital, Imperial College London, London, UK
Jessica Howell Division of Digestive Diseases, St Mary's Hospital, Imperial College London, London, UK
Liliane Mpabanzi Department of Surgery, Maastricht University Medical Centre, Maastricht University, Netherlands; NUTRIM School of Nutrition, Toxicology and Metabolism, Maastricht University, Netherlands; Hepato-Pancreato-Biliary and Liver Transplant Surgery, Royal Free Hospital, University College London, London, UK
Ousman Nyan Edward Francis Small Teaching Hospital (EFSTH), Banjul, The Gambia
Tumani Corrah Medical Research Council Laboratories, The Gambia Unit, Fajara, The Gambia
Hilton Whittle Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK
Simon D Taylor-Robinson Division of Digestive Diseases, St Mary's Hospital, Imperial College London, London, UK
Umberto D'Alessandro Medical Research Council Laboratories, The Gambia Unit, Fajara, The Gambia
Maimuna Mendy International Agency for Research on Cancer (IARC), Lyon, France
Mark R Thursz Division of Digestive Diseases, St Mary's Hospital, Imperial College London, London, UK.

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Eslam M, Hashem AM, Romero-Gomez M, Berg T, Dore GJ, Mangia A, Chan HLY, Irving WL, Sheridan D, Abate ML, Adams LA, Weltman M, Bugianesi E, Spengler U, Shaker O, Fischer J, Mollison L, Cheng W, Nattermann J, Riordan S, Miele L, Kelaeng KS, Ampuero J, Ahlenstiel G, McLeod D, Powell E, Liddle C, Douglas MW, Booth DR, George J. FibroGENE: A gene-based model for staging liver fibrosis. J Hepatol 2016;64:390-398. [PMID: 26592354 DOI: 10.1016/j.jhep.2015.11.008] [Citation(s) in RCA: 53] [Impact Index Per Article: 5.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/08/2015] [Revised: 11/02/2015] [Accepted: 11/09/2015] [Indexed: 12/13/2022]

Affiliation(s)

Mohammed Eslam Storr Liver Centre, The Westmead Millennium Institute for Medical Research and Westmead Hospital, The University of Sydney, NSW, Australia
Ahmed M Hashem Department of Systems and Biomedical Engineering, Faculty of Engineering, Minia University, Minia, Egypt
Manuel Romero-Gomez Unit for The Clinical Management of Digestive Diseases and CIBERehd, Hospital Universitario de Valme, Sevilla, Spain
Thomas Berg Medizinische Klinik m.S. Hepatologie und Gastroenterologie, Charite, Campus Virchow-Klinikum, Universitätsmedizin Berlin, Germany; Department of Hepatology, Clinic for Gastroenterology and Rheumatology, University Clinic Leipzig, Leipzig, Germany
Gregory J Dore Kirby Institute, The University of New South Wales, Sydney, NSW, Australia; St Vincent's Hospital, Sydney, NSW, Australia
Alessandra Mangia Division of Hepatology, Ospedale Casa Sollievo della Sofferenza, IRCCS, San Giovanni Rotondo, Italy
Henry Lik Yuen Chan Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China
William L Irving NIHR Biomedical Research Unit in Gastroenterology and the Liver, University of Nottingham, Nottingham, United Kingdom
David Sheridan Liver Research Group, Institute of Cellular Medicine, Medical School, Newcastle University, Newcastle upon Tyne, United Kingdom; Institute of Translational and Stratified Medicine, Plymouth University, United Kingdom
Maria Lorena Abate Division of Gastroenterology and Hepatology, Department of Medical Science, University of Turin, Turin, Italy
Leon A Adams School of Medicine and Pharmacology, Sir Charles Gairdner Hospital Unit, University of Western Australia, Nedlands, WA, Australia
Martin Weltman Department of Gastroenterology and Hepatology, Nepean Hospital, Sydney, NSW, Australia
Elisabetta Bugianesi Division of Gastroenterology and Hepatology, Department of Medical Science, University of Turin, Turin, Italy
Ulrich Spengler Department of Internal Medicine I, University of Bonn, Bonn, Germany
Olfat Shaker Medical Biochemistry and Molecular Biology Department, Faculty of Medicine, Cairo University, Cairo, Egypt
Janett Fischer Medizinische Klinik m.S. Hepatologie und Gastroenterologie, Charite, Campus Virchow-Klinikum, Universitätsmedizin Berlin, Germany
Lindsay Mollison School of Medicine and Pharmacology, Fremantle Hospital, UWA, Fremantle, WA, Australia
Wendy Cheng Department of Gastroenterology & Hepatology, Royal Perth Hospital, WA, Australia
Jacob Nattermann Department of Internal Medicine I, University of Bonn, Bonn, Germany
Stephen Riordan Gastrointestinal and Liver Unit, Prince of Wales Hospital and University of New South Wales, Sydney, NSW, Australia
Luca Miele Department of Internal Medicine, Catholic University of the Sacred Heart, Rome, Italy
Kebitsaone Simon Kelaeng Storr Liver Centre, The Westmead Millennium Institute for Medical Research and Westmead Hospital, The University of Sydney, NSW, Australia
Javier Ampuero Unit for The Clinical Management of Digestive Diseases and CIBERehd, Hospital Universitario de Valme, Sevilla, Spain
Golo Ahlenstiel Storr Liver Centre, The Westmead Millennium Institute for Medical Research and Westmead Hospital, The University of Sydney, NSW, Australia
Duncan McLeod Department of Anatomical Pathology, Institute of Clinical Pathology and Medical Research (ICPMR), Westmead Hospital, Sydney, Australia
Elizabeth Powell Princess Alexandra Hospital, Department of Gastroenterology and Hepatology, Woolloongabba, QLD, Australia; The University of Queensland, School of Medicine, Princess Alexandra Hospital, Woolloongabba, QLD, Australia
Christopher Liddle Storr Liver Centre, The Westmead Millennium Institute for Medical Research and Westmead Hospital, The University of Sydney, NSW, Australia
Mark W Douglas Storr Liver Centre, The Westmead Millennium Institute for Medical Research and Westmead Hospital, The University of Sydney, NSW, Australia
David R Booth Institute of Immunology and Allergy Research, Westmead Hospital and Westmead Millennium Institute, University of Sydney, NSW, Australia
Jacob George Storr Liver Centre, The Westmead Millennium Institute for Medical Research and Westmead Hospital, The University of Sydney, NSW, Australia.

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Exploring the Role of Killer Cell Immunoglobulin-Like Receptors and Their HLA Class I Ligands in Autoimmune Hepatitis. PLoS One 2016;11:e0146086. [PMID: 26744892 PMCID: PMC4712907 DOI: 10.1371/journal.pone.0146086] [Citation(s) in RCA: 25] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/10/2015] [Accepted: 11/25/2015] [Indexed: 01/06/2023] Open

Trovato FM, Tognarelli JM, Crossey MME, Catalano D, Taylor-Robinson SD, Trovato GM. Challenges of liver cancer: Future emerging tools in imaging and urinary biomarkers. World J Hepatol 2015;7:2664-2675. [PMID: 26609343 PMCID: PMC4651910 DOI: 10.4254/wjh.v7.i26.2664] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/22/2015] [Revised: 08/26/2015] [Accepted: 10/27/2015] [Indexed: 02/06/2023] Open

Abstract

Chronic liver disease has become a global health problem as a result of the increasing incidence of viral hepatitis, obesity and alcohol misuse. Over the past three decades, in the United Kingdom alone, deaths from chronic liver disease have increased both in men and in women. Currently, 2.5% of deaths worldwide are attributed to liver disease and projected figures suggest a doubling in hospitalisation and associated mortality by 2020. Chronic liver diseases vary for clinical manifestations and natural history, with some individuals having relatively indolent disease and others with a rapidly progressive course. About 30% of patients affected by hepatitis C has a progressive disease and develop cirrhosis over a 20 years period from the infection, usually 5-10 years after initial medical presentation. The aim of the current therapeutic strategies is preventing the progression from hepatitis to fibrosis and subsequently, cirrhosis. Hepatic steatosis is a risk factor for chronic liver disease and is affecting about the half of patients who abuse alcohol. Moreover non-alcoholic fatty liver disease is part of the metabolic syndrome, associated with obesity, hypertension, type II diabetes mellitus and dyslipidaemia, and a subgroup of patients develops non-alcoholic steatohepatitis and fibrosis with subsequent cirrhosis. The strengths and pitfalls of liver biopsy are discussed and a variety of new techniques to assess liver damage from transient elastography to experimental techniques, such as in vitro urinary nuclear magnetic resonance spectroscopy. Some of the techniques and tests described are already suitable for more widespread clinical application, as is the case with ultrasound-based liver diagnostics, but others, such as urinary metabonomics, requires a period of critical evaluation or development to take them from the research arena to clinical practice.

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Cirrhotic Multiorgan Syndrome. Dig Dis Sci 2015;60:3209-25. [PMID: 26112989 DOI: 10.1007/s10620-015-3752-3] [Citation(s) in RCA: 38] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/11/2015] [Accepted: 06/06/2015] [Indexed: 12/16/2022]

Califf RM, Sugarman J. Exploring the ethical and regulatory issues in pragmatic clinical trials. Clin Trials 2015;12:436-41. [PMID: 26374676 DOI: 10.1177/1740774515598334] [Citation(s) in RCA: 134] [Impact Index Per Article: 13.4] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/19/2022]

Qian F, Li M, Zhu CW. Impact of antiviral agents on levels of hepatitis B virus covalently closed circular DNA. Shijie Huaren Xiaohua Zazhi 2015;23:3495-3504. [DOI: 10.11569/wcjd.v23.i22.3495] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open

Gong LL, Zhao BB, Fan WF, Gong LY, Chen CF, Liu JJ, Lu X. Correlations of IFN-γ-inducible protein-10 with the risk of chronic hepatitis B and the efficacy of interferon therapy in Asians. INTERNATIONAL JOURNAL OF CLINICAL AND EXPERIMENTAL PATHOLOGY 2015;8:8367-8375. [PMID: 26339406 PMCID: PMC4555734] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Subscribe] [Scholar Register] [Received: 04/09/2014] [Accepted: 05/26/2015] [Indexed: 06/05/2023]

Crespo J, Diago M, Cabezas J, Berenguer M, Broquetas T, Serra MÁ, Morillas R, García-Samaniego J, Calleja JL, Sánchez JJ, Lens S, Soto-Fernández S, Sacristán B, Fernández I, López-Núñez C, Buti M, Romero-Gómez M, Sáez-Royuela F, Fernández C, Jorquera F, Sánchez-Antolín G, Pascasio JM, Cuadrado A, Hernández-Guerra M. High efficacy and safety of triple therapy in HCV genotype 1 and moderate fibrosis: a multicenter study of clinical practice in Spain. Ann Hepatol 2015;14:477-486. [PMID: 26019034 DOI: 10.1016/s1665-2681(19)31169-x] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 03/31/2023]

Chen CY, Huang SY, Cheng A, Chou WC, Yao M, Tang JL, Tsay W, Sheng WH, Tien HF. High Risk of Hepatitis B Reactivation among Patients with Acute Myeloid Leukemia. PLoS One 2015;10:e0126037. [PMID: 25973905 PMCID: PMC4431821 DOI: 10.1371/journal.pone.0126037] [Citation(s) in RCA: 18] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/20/2014] [Accepted: 03/27/2015] [Indexed: 12/18/2022] Open

Wedemeyer H, Dore GJ, Ward JW. Estimates on HCV disease burden worldwide - filling the gaps. J Viral Hepat 2015;22 Suppl 1:1-5. [PMID: 25560838 DOI: 10.1111/jvh.12371] [Citation(s) in RCA: 86] [Impact Index Per Article: 8.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]

Eikermann M, Holzmann N, Siering U, Rüther A. Tools for assessing the content of guidelines are needed to enable their effective use--a systematic comparison. BMC Res Notes 2014;7:853. [PMID: 25427972 PMCID: PMC4258382 DOI: 10.1186/1756-0500-7-853] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/21/2014] [Accepted: 11/18/2014] [Indexed: 01/08/2023] Open

Abstract

Background

To ensure that clinical practice guidelines (CPGs) form a sound basis for decision-making in health care, it is necessary to be able to reliably assess and ensure their quality. This results in the need to assess the content of guidelines systematically, particularly with regard to the validity of their recommendations.

The aim of the present analysis was to determine the suitability and applicability of frequently used assessment tools for evidence syntheses with regard to the assessment of guideline content.

Methods

We conducted a systematic comparison and analysis of established tools for the assessment of evidence syntheses (guidelines, systematic reviews, health technology assessments). The tools analyzed were: ADAPTE, AGREE II, AMSTAR, GLIA and the INAHTA checklist. We analyzed methodological steps related to the assessment of the reliability and validity of guideline recommendations. Data were extracted and analyzed by two persons independently of one another.

Results

Widely used tools for the methodological assessment of evidence syntheses are not suitable for a comprehensive content-related assessment. They remain mostly at the level of assessment of the documentation of processes. Some tools assess selected content-related aspects, but operationalization is either unspecific or lacking.

Conclusion

None of the tools analyzed enables the structured and comprehensive assessment of the content of guideline recommendations with special regard to their reliability and validity. All tools contribute towards the judicious use of evidence syntheses by supporting their systematic development or assessment. However, further progress is needed, particularly with regard to the assessment of content quality. This includes comprehensive operationalization and documentation of the assessment process to ensure reliability and validity, and therefore to enable the effective use of trustworthy guidelines in the health care system.

Electronic supplementary material

The online version of this article (doi:10.1186/1756-0500-7-853) contains supplementary material, which is available to authorized users.

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Sabharwal S, Patel NK, Gauher S, Holloway I, Athansiou T, Athansiou T. High methodologic quality but poor applicability: assessment of the AAOS guidelines using the AGREE II instrument. Clin Orthop Relat Res 2014;472:1982-8. [PMID: 24566890 PMCID: PMC4016437 DOI: 10.1007/s11999-014-3530-0] [Citation(s) in RCA: 58] [Impact Index Per Article: 5.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/03/2013] [Accepted: 02/12/2014] [Indexed: 01/31/2023]

Abstract

BACKGROUND

The American Academy of Orthopaedic Surgeons (AAOS) is a globally recognized leader in musculoskeletal and orthopaedic education. Clinical guidelines are one important focus of the AAOS' educational efforts. Although their recommendations sometimes generate controversy, a critical appraisal of the overall quality of these guidelines has not, to our knowledge, been reported.

QUESTIONS/PURPOSES

We wished to assess the overall quality of the AAOS guidelines using the AGREE II (Advancing Guideline Development, Reporting and Evaluation in Health Care) instrument.

METHODS

All 14 guidelines available on the AAOS website as of August 2, 2013 were evaluated. Appraisal was performed by three reviewers, independently, using the AGREE II instrument. This is an internationally recognized and validated assessment tool for evaluating guideline quality. Interrater reliability was calculated and descriptive statistics were performed. Strong interrater reliability was shown using a Spearman's Rho test (correlation coefficient ≥ 0.95).

RESULTS

The overall results for AGREE II domains across all 14 guidelines were: scope and purpose (median score, 95%), stakeholder involvement (median score, 83%), rigor of development (median score, 94%), clarity of presentation (median score, 92%), applicability (median score, 48%), and editorial independence (median score, 79%).

CONCLUSIONS

This study showed that the overall quality of the AAOS guidelines is high, however their applicability was found to be poor. The value of guidelines that have a high quality but that are difficult for clinicians to implement is questionable. Numerous suggestions have been proposed to improve applicability including; health economist involvement in guideline production, implementation of pilot studies and audit to monitor uptake of the guidelines and clinician feedback sessions and barrier analysis studies. Future AAOS guidelines should consider and implement steps that can improve their applicability.

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Rowe IA, Parker R, Armstrong MJ, King AL, Houlihan DD, Mutimer DJ. Improving the quality of clinical practice guidelines for clinicians and patients. Hepatology 2014;59:2055-6. [PMID: 24123187 DOI: 10.1002/hep.26756] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/24/2013] [Accepted: 08/22/2013] [Indexed: 12/07/2022]