Patrick Bossuyt

University of Amsterdam | UVA · Department of Clinical Epidemiology and Biostatistics

This article provides a practical guide for clinicians and radiologists to critically evaluate diagnostic accuracy systematic reviews when using them to inform clinical decisions. Systematic reviews of diagnostic accuracy studies can provide the best available evidence to inform decisions regarding the use of a diagnostic test. In this guide, the...

Objective: To assess adverse perinatal outcomes and caesarean section of low-risk women receiving elective induction of labour at 41 weeks or expectant management until 42 weeks according to their preferred and actual management strategy. Design: Multicentre prospective cohort study alongside RCT. Setting: 90 midwifery practices and 12 hospitals in...

Purpose: The aim of the study was to compare diagnostic accuracy of dual-energy computed tomography (DECT) and magnetic resonance imaging (MRI) to detect enhancement in renal masses. Methods: Adults renal masses of 10 mm or greater with both fast kilovoltage potential switching DECT and contrast-enhanced MRI performed within 12 months were retro...

Background: Mother-to-baby transmission of group B Streptococcus (GBS) is the main cause of early-onset infection. We evaluated whether, in women with clinical risk factors for early neonatal infection, the use of point-of-care rapid intrapartum test to detect maternal GBS colonisation reduces maternal antibiotic exposure compared with usual care,...

Reflecterend testen houdt in dat de laboratoriumspecialist een test niet louter protocollair uitvoert, maar de resultaten interpreteert, van commentaar voorziet en zo nodig aanvullende tests doet. Bij diverse diagnoses kan reflecterend testen zinvol zijn en het beleid van de huisarts adequater maken, zo blijkt uit dit onderzoek.

Objective To develop an international definition for hyperemesis gravidarum to assist in clinical diagnosis and harmonize hyperemesis gravidarum definition for study populations. Study design: A mixed-methods approach was used to identify potential hyperemesis gravidarum definition criteria (i.e. systematic review, semi-structured interviews and cl...

Objectives: (1) To identify and classify comparative diagnostic test accuracy (DTA) study designs; and (2) to describe study design labels used by authors of comparative DTA studies. Methods: We performed a methodological review of 100 comparative DTA studies published between 2015 and 2017, randomly sampled from studies included in 238 comparative...

Objectives: This article provides GRADE guidance on how authors of evidence syntheses and health decision makers, including guideline developers, can rate the certainty across a body of evidence for comparative test accuracy questions. Study design and setting: This guidance extends the previously published GRADE guidance for assessing certainty of...

Occult cancer is detected in about 5% of patients with unprovoked venous thromboembolism (VTE) in the 12 months following VTE diagnosis. Current guidance suggests conducting a ‘limited’ cancer screening in these patients, consisting of medical history taking, physical examination, routine blood tests, chest X-ray, and age- and gender-specific testi...

Background A false-negative case of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is defined as a person with suspected infection and an initial negative result by reverse transcription-polymerase chain reaction (RT-PCR) test, with a positive result on a subsequent test. False-negative cases have important implications for...

Background: Polygenic risk scores (PRS) could potentially improve breast cancer screening recommendations. We analyzed how well a recently developed prevalence-based breast cancer PRS (Läll et al., 2009) performs in expressing women’s future risk of incident breast cancer. Objectives: To evaluate the prognostic performance of models using PRS and a...

Background: A challenge in imaging research is a diagnostic classification of study participants. We hypothesised that a structured approach would be efficient and that classification by medical students, residents, and an expert panel whenever necessary would be as valid as classification of all patients by experts. Methods: OPTIMACT is a rando...

Objective After prophylactic colectomy, adenomas continue to develop in the remaining intestine of patients with familial adenomatous polyposis (FAP). There is a lack of standard clinical recommendation for chemoprevention in patients with FAP. Because of promising in vivo studies, the aim of this pilot study was to investigate the safety of siroli...

Purpose of investigation: To externally validate the rule of Van Meurs et al. for selecting patients with advanced epithelial ovarian cancer for treatment with primary surgery or neoadjuvant chemotherapy (NACT). Materials and Methods: We analysed a historical cohort of 900 consecutive patients with FIGO stage IIIC/IV ovarian cancer treated for adva...

Comparative accuracy studies evaluate the relative performance of two or more diagnostic tests. As any other form of research, such studies should be reported in an informative manner, to allow replication and to be useful for decision‐making. In this study we aimed to assess whether and how components of test comparisons were reported in comparati...

Objective: The purpose of this study is to evaluate whether imaging diagnostic test accuracy (DTA) studies with positive conclusions or titles have a shorter time to publication than those with nonpositive (i.e., negative or neutral) conclusions or titles. Materials and methods: We included primary imaging DTA studies from systematic reviews pub...

Background Reflective testing, i.e. interpreting, commenting on and, if necessary, adding tests in order to aid the diagnostic process in a meaningful and efficient manner, is an extra service provided by laboratory medicine. However, there have been no prospective randomized controlled trials investigating the value of reflective testing in patien...

Guidelines suggest thromboprophylaxis for ambulatory cancer patients starting chemotherapy with an intermediate to high risk of venous thromboembolism (VTE) according to Khorana score. Data on thromboprophylaxis efficacy in different Khorana score risk groups remain ambiguous. We sought to evaluate thromboprophylaxis in patients with an intermediat...

Objective: To estimate the effect of an intervention compared to the usual peer-review process on reducing spin in the abstract’s conclusion of biomedical study reports. Study Design and Setting: We conducted a two-arm, parallel-group RCT in a sample of primary research manuscripts submitted to BMJ Open. Authors received short instructions alongsid...

Background: Study-level meta-analyses provide high-certainty evidence that heparin reduces the risk of symptomatic venous thromboembolism for patients with cancer; however, whether the benefits and harms associated with heparin differ by cancer type is unclear. This individual participant data meta-analysis of randomised controlled trials examines...

Objectives: To systematically assess the extent to which bone scintigraphy (BS) could improve the detection rate of skeletal injury in children suspected of physical abuse with an initial negative radiological skeletal survey (RSS). Study design: We searched MEDLINE and Web of Science for series of ≥20 children suspected of physical abuse who un...

Background: New diagnostic tests to identify a well-established disease state must undergo a series of scientific studies from test construction to finally demonstrating a societal impact. Traditionally, these studies are performed with substantial time gaps in between, resulting in a long time period from the initial idea to roll out in clinical...

Background & aims: Fibrosis is the strongest predictor for long-term clinical outcomes among patients with non-alcoholic fatty liver disease (NAFLD). There is growing interest in employing non-invasive methods for risk stratification based on prognosis. FIB-4, NFS and APRI are models commonly used for detecting fibrosis among NAFLD patients. We ai...

Background: The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) Statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did and what they found. Over the last decade, there have been many advances in systematic review methodology and terminolo...

The methods and results of systematic reviews should be reported in sufficient detail to allow users to assess the trustworthiness and applicability of the review findings. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement was developed to facilitate transparent and complete reporting of systematic reviews an...

Objectives: To describe the processes used to update the PRISMA 2009 statement for reporting systematic reviews, present results of a survey conducted to inform the update, summarise decisions made at the PRISMA update meeting, and describe and justify changes made to the guideline.Methods: We reviewed 60 documents with reporting guidance for syste...

Introduction Association between elevated cytokeratin 18 (CK-18) levels and hepatocyte death has made circulating CK-18 a candidate biomarker to differentiate non-alcoholic fatty liver from non-alcoholic steatohepatitis (NASH). Yet studies produced variable diagnostic performance. We aimed to provide summary estimates with increased precision for t...

Importance: The benefit of adjuvant chemotherapy after resection of pancreatic cancer following neoadjuvant combination treatment with folinic acid, fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX) is unclear. Objective: To assess the association of adjuvant chemotherapy with overall survival (OS) in patients after pancreatic cancer resect...

Background: Most studies evaluating the effect of Xpert MTB/RIF testing for tuberculosis (TB) concluded that it did not reduce overall mortality compared to usual care. We conducted a systematic review to assess whether key study design and execution features contributed to earlier identification of patients with TB and decreased pre-treatment loss...

Systematic reviews of diagnostic test accuracy (DTA) studies are fundamental to the decision making process in evidence based medicine. Although such studies are regarded as high level evidence, these reviews are not always reported completely and transparently. Suboptimal reporting of DTA systematic reviews compromises their validity and generalis...

Observational comparative research on the effect of pharmaceuticals or other medical interventions is sometimes conducted, even after the results of large randomised trials have been made available. Does that make any sense? This contribution lists a few of the reasons why observational research should be conducted, even after an RCT has already be...

Background Heavy menstrual bleeding affects the physical functioning and social well-being of many women. The levonorgestrel intrauterine system and endometrial ablation are two frequently applied treatments in women with heavy menstrual bleeding. Objective The objective of this study is to compare the effectiveness of the levonorgestrel intrauter...

Objective: To determine the yield of preoperative screening for COVID-19 with chest CT and RT-PCR in patients without COVID-19 symptoms. Summary of background data: Many centers are currently screening surgical patients for COVID-19 using either chest CT, RT-PCR or both, due to the risk for worsened surgical outcomes and nosocomial spread. The o...

In battling the COVID-19 pandemic, testing is essential. The detection of viral RNA allows the identification of infected persons, while the detection of antibodies may reveal a response to a previous infection. Tests for coronavirus should be rigorously evaluated in terms of their analytical and clinical performance. This poses not only logistic c...

Randomized controlled trials (RCTs) are the cornerstone of evidence-based medicine. In this series in Fertility and Sterility, several aspects of RCTs are discussed, with contributions on multicenter RCTs, different international settings, and integrity of RCTs. The present contribution deals with methodologic issues. We discuss different types of...

Background and Aims Almost all patients with familial adenomatous polyposis (FAP) develop duodenal adenomas, with a 4% to 18% risk of progression into duodenal cancer. Prophylactic endoscopic resection of duodenal adenomas may prevent cancer and is considered safer than surgical alternatives; however, data are limited. Therefore, the aim of this st...

Background: To compare the frequency of "spin" in systematic reviews of diagnostic accuracy studies in high-impact journals with the frequency a previously assessed series of reviews. Methods: Medline was searched from January 2010 to January 2019. Systematic reviews of diagnostic accuracy studies were included if they reported a meta-analysis a...

Background: A chest X-ray is a standard imaging procedure in the diagnostic work-up of patients suspected of having non-traumatic pulmonary disease. Compared to a chest X-ray, an ultra-low-dose (ULD) chest computed tomography (CT) scan provides substantially more detailed information on pulmonary conditions. To what extent this translates into an...

Background: Rapid reviews (RRs) have emerged as an efficient alternative to time-consuming systematic reviews-they can help meet the demand for accelerated evidence synthesis to inform decision-making in healthcare. The synthesis of diagnostic evidence has important methodological challenges. Here, we performed an international survey to identify...

Direct oral anticoagulants (DOACs) are an emerging treatment option for cancer patients with acute venous thromboembolism (VTE), but studies have reported inconsistent results. This systematic review and meta-analysis compared the efficacy and safety of DOACs and low-molecular-weight heparins (LMWH) in these patients. MEDLINE, Embase, CENTRAL, and...

Background Oncology guidelines suggest using the Khorana score to select ambulatory cancer patients receiving chemotherapy for primary venous thromboembolism (VTE) prevention, but its performance in different cancers remains uncertain. Objective To examine the performance of the Khorana score in assessing 6‐month VTE risk, and the efficacy and saf...

Faecal immunochemical testing (FIT) is suboptimal in detecting advanced neoplasia (AN). To increase the sensitivity and yield of a FIT-based screening programme, FIT could be combined with risk factors for AN. We evaluated the incremental yield of adding a family history questionnaire (FHQ) on colorectal cancer (CRC) and Lynch syndrome-associated t...

BACKGROUND AND AIMS: The Enhanced Liver Fibrosis (ELF) test is a non-invasive biomarker, suggested as an appropriate test for advanced liver fibrosis in non-alcoholic fatty liver disease (NAFLD). This systematic review aimed to provide summary estimates of the accuracy of this test against biopsy. METHODS: In this systematic review, we searched ME...

Background and Aims The Enhanced Liver Fibrosis (ELF) test is a non-invasive biomarker, suggested as an appropriate test for advanced liver fibrosis in non-alcoholic fatty liver disease (NAFLD). This systematic review aimed to provide summary estimates of the accuracy of this test against biopsy. Methods In this systematic review, we searched MEDL...

BACKGROUND Rapid reviews (RRs) have emerged as an efficient alternative to time-consuming systematic reviews—they can help meet the demand for accelerated evidence synthesis to inform decision-making in healthcare. The synthesis of diagnostic evidence has important methodological challenges. Here, we performed an international survey to identify th...

Objective To explore contextual factors associated with high or low risk of bias judgement in case of incomplete or unclear information in study reports. Study design and setting Research-on-research study, using matched case–control design, with a sample of 304 RCTs included in two Cochrane reviews for which there was disagreement on the risk of...

Background Compression ultrasonography (CUS) is the first-line imaging test in the diagnostic management of suspected deep vein thrombosis (DVT) of the lower extremity. Three CUS strategies are used in clinical practice. However, their relative diagnostic accuracy is uncertain. Objectives This systematic review and meta-analysis aimed to summarize...

Objective: What are the cost per live birth and the incremental cost of preventing a miscarriage with preimplantation genetic testing for aneuploidy (PGT-A) by polar body biopsy and array-based comprehensive genome hybridisation (aCGH) versus regular IVF/ICSI without PGT-A for infertility treatment in women 36-40 years of age? Design: Decision t...

Objectives: This article provides updated GRADE guidance about how authors of systematic reviews and health technology assessments (HTA) and guideline developers can rate the certainty of evidence (also known as quality of the evidence or confidence in the estimates) of a body of evidence addressing test accuracy (TA) on the domains imprecision, i...

Objectives: This article provides updated GRADE guidance about how authors of systematic reviews and health technology assessments (HTA) and guideline developers can assess the results and the certainty of evidence (also known as quality of the evidence or confidence in the estimates) of a body of evidence addressing test accuracy (TA). Study des...

Background Uric acid stone diagnosis is presently done primarily with in vitro analysis of stones. In vivo diagnosis with dual-energy CT (DECT) would allow earlier initiation of therapy with urine alkalinization and avoid surgical intervention. Objective To evaluate if DECT, using stone analysis as reference standard, is sufficiently accurate to r...

Objective To evaluate whether imaging diagnostic test accuracy conference abstracts with positive conclusions or titles are more likely to reach full-text publication than those with negative (or neutral) conclusions or titles. Methods Diagnostic accuracy research abstracts were included if they were presented at the 2011 or 2012 Radiological Soci...

Background: Standardized reporting methods facilitate comparisons between studies. Reporting of data on benefits and harms of treatments in surgical RCTs should support clinical decision-making. Correct and complete reporting of the outcomes of clinical trials is mandatory to appreciate available evidence and to inform patients properly before ask...

Abstract Most randomized controlled trials evaluating medical interventions have a pre-specified hypothesis, which is statistically tested against the null hypothesis of no effect. In diagnostic accuracy studies, study hypotheses are rarely pre-defined and sample size calculations are usually not performed, which may jeopardize scientific rigor and...

( BMJ . 2019;364:I344) Because of the fact that postterm pregnancy (defined as pregnancy extended to or beyond 42 weeks gestation) has been associated with increased perinatal morbidity and mortality, induction of labor is recommended after 42 weeks gestation. Although the probability of positive outcomes for neonates born between 40 and 42 weeks g...

Background: In the scientific literature, ''spin'' refers to reporting practices that make the study findings appear more favorable than results justify. The practice of ''spin'' or misrepresentation and overinterpretation may lead to an imbalanced and unjustified optimism in the interpretation of study results about performance of putative biomark...

The aim of diagnostic accuracy studies is to evaluate how accurately a diagnostic test can distinguish diseased from nondiseased individuals. Depending on the research question, different study designs and accuracy measures are appropriate. As the prior knowledge in the planning phase is often very limited, modifications of design aspects such as t...

Background: Studies evaluating the impact of Xpert MTB/RIF testing for tuberculosis (TB) have demonstrated varied effects on health outcomes with many studies showing inconclusive results. We explored perceptions among diverse stakeholders about studies evaluating the impact of TB diagnostic tests, and identified suggestions for improving these stu...

Introduction: Many diagnostic accuracy studies are never reported in full in a peer-reviewed journal. Searching for unpublished studies may avoid bias due to selective publication, enrich the power of systematic reviews, and thereby help to reduce research waste. We assessed searching practices among recent systematic reviews of diagnostic accurac...

Background: Most studies evaluating the effect of Xpert MTB/RIF testing for tuberculosis (TB) concluded that it did not reduce overall mortality compared to usual care. We conducted a systematic review to assess whether key study design and execution features contributed to earlier identification of patients with TB and decreased pre-treatment loss...

Objectives: To generate a comprehensive bank of systematic review (SR) reporting items to inform an update of the PRISMA 2009 statement. Methods: We searched the EQUATOR Network library in May 2019 to identify all reporting guidelines for SRs that were published after 2009, regardless of the scope of the guideline. We also conducted a selective...

(Abstracted from Human Reproduction 2018;33(9):1767–1776) Preimplantation genetics for aneuploidy (PGT-A) has shown mixed results on pregnancy rates when applied at the cleavage stage of development due to a high rate of mosaicism and limitations of the comprehensive chromosomal screening technology, FISH, which was available at the time. A pilot s...

Objective: To evaluate whether there is a differential benefit from planned cesarean delivery (CD) for women with a twin pregnancy and a cephalic-presenting first twin; depending on a pre-specified list of maternal and pregnancy characteristics (markers), and/or gestational age (GA) at delivery. Methods: We performed a secondary analysis of the...

Background: Clinical management for unexplained infertility includes expectant management as well as active treatments, including ovarian stimulation (OS), intrauterine insemination (IUI), OS-IUI, and in vitro fertilisation (IVF) with or without intracytoplasmic sperm injection (ICSI).Existing systematic reviews have conducted head-to-head compari...

Background: A variety of study designs are available to evaluate the accuracy of tests, but the terms used to describe these designs seem to lack clarity and standardization. We investigated if this was the case in the diagnostic guidance of the National Institute of Care and Health Excellence (NICE), an influential source of advice on the value o...

Background & aims: Guidelines recommend that individuals with familial colorectal cancer undergo colonoscopy surveillance instead of average-risk screening. However, these recommendations vary widely. To substantiate appropriate surveillance strategies, precise and valid evidence-based risk estimates are needed for individuals with a family histor...

Objectives: - To clarify a difference between two approaches while evaluating the diagnostic accuracy of medical tests, labeled here as "pragmatic" versus "explanatory" studies. Methods: - Using the definitions and characteristics described by Schwartz and Lellouch for randomized trials of interventions, and Schwartz' more general distinction be...

Background & aims: Some colorectal cancer (CRC) screening programs use 2-sample fecal immunochemical tests (FITs). We aimed to assess advanced neoplasia (AN) yield of 2 different FIT assays performed on the same bowel movement and have discordant results. Methods: We conducted a large prospective comparative accuracy study within the Dutch natio...