Study protocol for a multicentre nationwide prospective cohort study to investigate the natural course and clinical outcome in benign liver tumours and cysts in the Netherlands: the BELIVER study

There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

Abstract

Introduction

Benign liver tumours and cysts (BLTCs) comprise a heterogeneous group of cystic and solid lesions, including hepatic haemangioma, focal nodular hyperplasia and hepatocellular adenoma. Some BLTCs, for example, (large) hepatocellular adenoma, are at risk of complications. Incidence of malignant degeneration or haemorrhage is low in most other BLTCs. Nevertheless, the diagnosis BLTC may carry a substantial burden and patients may be symptomatic, necessitating treatment. The indications for interventions remain matter of debate. The primary study aim is to investigate patient-reported outcomes (PROs) of patients with BLTCs, with special regards to the influence of invasive treatment as compared with the natural course of the disease.

Methods and analysis

A nationwide observational cohort study of patients with BLTC will be performed between October 2021 and October 2026, the minimal follow-up will be 2 years. During surveillance, a questionnaire regarding symptoms and their impact will be sent to participants on a biannual basis and more often in case of invasive intervention. The questionnaire was previously developed based on PROs considered relevant to patients with BLTCs and their caregivers. Most questionnaires will be administered by computerised adaptive testing through the Patient-Reported Outcomes Measurement Information System. Data, such as treatment outcomes, will be extracted from electronic patient files. Multivariable analysis will be performed to identify patient and tumour characteristics associated with significant improvement in PROs or a complicated postoperative course.

Ethics and dissemination

The study was assessed by the Medical Ethics Committee of the University Medical Center Groningen and the Amsterdam UMC. Local consultants will provide information and informed consent will be asked of all patients. Results will be published in a peer-reviewed journal.

Study registration

NL8231—10 December 2019; Netherlands Trial Register.

Related collections

Most cited references 27

Record: found
Abstract: found
Article: not found

New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1).

E A Eisenhauer, P Therasse, J Bogaerts … (2009)

Assessment of the change in tumour burden is an important feature of the clinical evaluation of cancer therapeutics: both tumour shrinkage (objective response) and disease progression are useful endpoints in clinical trials. Since RECIST was published in 2000, many investigators, cooperative groups, industry and government authorities have adopted these criteria in the assessment of treatment outcomes. However, a number of questions and issues have arisen which have led to the development of a revised RECIST guideline (version 1.1). Evidence for changes, summarised in separate papers in this special issue, has come from assessment of a large data warehouse (>6500 patients), simulation studies and literature reviews. HIGHLIGHTS OF REVISED RECIST 1.1: Major changes include: Number of lesions to be assessed: based on evidence from numerous trial databases merged into a data warehouse for analysis purposes, the number of lesions required to assess tumour burden for response determination has been reduced from a maximum of 10 to a maximum of five total (and from five to two per organ, maximum). Assessment of pathological lymph nodes is now incorporated: nodes with a short axis of 15 mm are considered measurable and assessable as target lesions. The short axis measurement should be included in the sum of lesions in calculation of tumour response. Nodes that shrink to <10mm short axis are considered normal. Confirmation of response is required for trials with response primary endpoint but is no longer required in randomised studies since the control arm serves as appropriate means of interpretation of data. Disease progression is clarified in several aspects: in addition to the previous definition of progression in target disease of 20% increase in sum, a 5mm absolute increase is now required as well to guard against over calling PD when the total sum is very small. Furthermore, there is guidance offered on what constitutes 'unequivocal progression' of non-measurable/non-target disease, a source of confusion in the original RECIST guideline. Finally, a section on detection of new lesions, including the interpretation of FDG-PET scan assessment is included. Imaging guidance: the revised RECIST includes a new imaging appendix with updated recommendations on the optimal anatomical assessment of lesions. A key question considered by the RECIST Working Group in developing RECIST 1.1 was whether it was appropriate to move from anatomic unidimensional assessment of tumour burden to either volumetric anatomical assessment or to functional assessment with PET or MRI. It was concluded that, at present, there is not sufficient standardisation or evidence to abandon anatomical assessment of tumour burden. The only exception to this is in the use of FDG-PET imaging as an adjunct to determination of progression. As is detailed in the final paper in this special issue, the use of these promising newer approaches requires appropriate clinical validation studies.

0 comments Cited 5858 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey.

Daniel Dindo, Nicolas Demartines, Pierre-Alain Clavien (2004)

Although quality assessment is gaining increasing attention, there is still no consensus on how to define and grade postoperative complications. This shortcoming hampers comparison of outcome data among different centers and therapies and over time. A classification of complications published by one of the authors in 1992 was critically re-evaluated and modified to increase its accuracy and its acceptability in the surgical community. Modifications mainly focused on the manner of reporting life-threatening and permanently disabling complications. The new grading system still mostly relies on the therapy used to treat the complication. The classification was tested in a cohort of 6336 patients who underwent elective general surgery at our institution. The reproducibility and personal judgment of the classification were evaluated through an international survey with 2 questionnaires sent to 10 surgical centers worldwide. The new ranking system significantly correlated with complexity of surgery (P < 0.0001) as well as with the length of the hospital stay (P < 0.0001). A total of 144 surgeons from 10 different centers around the world and at different levels of training returned the survey. Ninety percent of the case presentations were correctly graded. The classification was considered to be simple (92% of the respondents), reproducible (91%), logical (92%), useful (90%), and comprehensive (89%). The answers of both questionnaires were not dependent on the origin of the reply and the level of training of the surgeons. The new complication classification appears reliable and may represent a compelling tool for quality assessment in surgery in all parts of the world.

0 comments Cited 3427 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008.

David Cella, William A. Riley, Arthur A Stone … (2010)

Patient-reported outcomes (PROs) are essential when evaluating many new treatments in health care; yet, current measures have been limited by a lack of precision, standardization, and comparability of scores across studies and diseases. The Patient-Reported Outcomes Measurement Information System (PROMIS) provides item banks that offer the potential for efficient (minimizes item number without compromising reliability), flexible (enables optional use of interchangeable items), and precise (has minimal error in estimate) measurement of commonly studied PROs. We report results from the first large-scale testing of PROMIS items. Fourteen item pools were tested in the U.S. general population and clinical groups using an online panel and clinic recruitment. A scale-setting subsample was created reflecting demographics proportional to the 2000 U.S. census. Using item-response theory (graded response model), 11 item banks were calibrated on a sample of 21,133, measuring components of self-reported physical, mental, and social health, along with a 10-item Global Health Scale. Short forms from each bank were developed and compared with the overall bank and with other well-validated and widely accepted ("legacy") measures. All item banks demonstrated good reliability across most of the score distributions. Construct validity was supported by moderate to strong correlations with legacy measures. PROMIS item banks and their short forms provide evidence that they are reliable and precise measures of generic symptoms and functional reports comparable to legacy instruments. Further testing will continue to validate and test PROMIS items and banks in diverse clinical populations. Copyright © 2010 Elsevier Inc. All rights reserved.

0 comments Cited 914 times – based on 0 reviews      Review now

Bookmark

All references

Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2022

Publication date (Electronic): 8 September 2022

Volume: 12

Issue: 9

Electronic Location Identifier: e055104

Affiliations

[1 ] departmentDepartment of Surgery , Amsterdam UMC location University of Amsterdam , Amsterdam, The Netherlands

[2 ] Amsterdam Gastroenterology Endocrinology Metabolism , Amsterdam, The Netherlands

[3 ] departmentDepartment of Surgery , University Medical Centre Groningen, University of Groningen , Groningen, The Netherlands

[4 ] departmentDepartment of Surgery , Erasmus Medical Center, Erasmus University Rotterdam , Rotterdam, The Netherlands

[5 ] departmentDepartment of Gastroenterology and Hepatology , Erasmus Medical Center, Erasmus University Rotterdam , Rotterdam, The Netherlands

[6 ] departmentDepartment of Radiology , Erasmus Medical Center, Erasmus University Rotterdam , Rotterdam, The Netherlands

[7 ] departmentDepartment of Gastroenterology and Hepatology , Maastricht University Medical Centre+, Maastricht University , Maastricht, The Netherlands

[8 ] departmentDepartment of Surgery , Maastricht University Medical Centre+, Maastricht University , Maastricht, The Netherlands

[9 ] departmentDepartment of Gastroenterology and Hepatology , Leiden University Medical Center, Leiden University , Leiden, The Netherlands

[10 ] departmentDepartment of Surgery , Leiden University Medical Center, Leiden University , Leiden, The Netherlands

[11 ] departmentDepartment of Radiology , University Medical Centre Groningen, University of Groningen , Groningen, The Netherlands

[12 ] departmentDepartment of Pathology and Medical Biology , University Medical Centre Groningen, University of Groningen , Groningen, The Netherlands

[13 ] departmentDepartment of Surgery , Amsterdam UMC location Vrije Universiteit Amsterdam , Amsterdam, The Netherlands

[14 ] Cancer Center Amsterdam , Amsterdam, the Netherlands

[15 ] departmentDepartment of Radiology , Amsterdam UMC location University of Amsterdam , Amsterdam, The Netherlands

[16 ] departmentDepartment of Pathology , Amsterdam UMC location University of Amsterdam , Amsterdam, The Netherlands

[17 ] departmentDepartment of Gastroenterology and Hepatology , Amsterdam UMC location University of Amsterdam , Amsterdam, The Netherlands

[18 ] departmentDepartment of Gastroenterology and Hepatology , University Medical Centre Groningen, University of Groningen , Groningen, The Netherlands

Author notes

[Correspondence to ] Dr Joris I Erdmann; j.i.erdmann@ 123456amsterdamumc.nl

VEDM and JIE are joint senior authors.

AF and MPDH are joint first authors.

Author information

Alicia Furumaya http://orcid.org/0000-0001-5897-0438

Article

Publisher ID: bmjopen-2021-055104

DOI: 10.1136/bmjopen-2021-055104

PMC ID: 9462085

SO-VID: 3d4dda77-b16c-4f8a-b2b0-c67c6c5fd2f4

License:

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

History

Date received : 05 July 2021

Date accepted : 01 June 2022

Funding

Funded by: Amsterdam UMC location AMC;

Award ID: Personal grant to A. Furumaya

Funded by: Dutch Society of Gastroenterology (Nederlandse Vereniging voor Gastroenterologie);

Award ID: Grant to the Dutch Benign Liver Tumour Group

Custom metadata

special-feature unlocked

ScienceOpen disciplines: Medicine

Keywords: hepatobiliary surgery,hepatobiliary tumours,hepatobiliary disease

Data availability:

ScienceOpen disciplines: Medicine

Keywords: hepatobiliary surgery, hepatobiliary tumours, hepatobiliary disease

Comments

Comment on this article

scite_

Cited by 2

See all cited by

Most referenced authors 563

See all reference authors

Study protocol for a multicentre nationwide prospective cohort study to investigate the natural course and clinical outcome in benign liver tumours and cysts in the Netherlands: the BELIVER study

Read this article at

Abstract

Introduction

Methods and analysis

Ethics and dissemination

Study registration

Related collections

Journal of the Netherlands Society of Toxicology

Most cited references 27

New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1).

Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey.

The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008.

Author and article information

Journal

Affiliations

Author notes

Author information

Article

History

Funding

Categories

Custom metadata

Comments

Comment on this article

Similar content 278

Cited by 2

Most referenced authors 563