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6. Time-lag bias induced by unobserved heterogeneity: comparing treated patients to controls with a different start of follow-up

Author

van Eekelen, Rik, Bossuyt, Patrick M. M., and van Geloven, Nan

Subjects
Statistics - Methodology
Abstract

In comparative effectiveness research, treated and control patients might have a different start of follow-up as treatment is often started later in the disease trajectory. This typically occurs when data from treated and controls are not collected within the same source. Only patients who did not yet experience the event of interest whilst in the control condition end up in the treatment data source. In case of unobserved heterogeneity, these treated patients will have a lower average risk than the controls. We illustrate how failing to account for this time-lag between treated and controls leads to bias in the estimated treatment effect. We define estimands and time axes, then explore five methods to adjust for this time-lag bias by utilising the time between diagnosis and treatment initiation in different ways. We conducted a simulation study to evaluate whether these methods reduce the bias and then applied the methods to a comparison between fertility patients treated with insemination and similar but untreated patients. We conclude that time-lag bias can be vast and that the time between diagnosis and treatment initiation should be taken into account in the analysis to respect the chronology of the disease and treatment trajectory.

Published
2021

7. A non-randomized risk-adjusted comparison of lenalidomide + R-CHOP versus R-CHOP for MYC-rearranged DLBCL patients

Author

de Jonge, A. Vera, van Werkhoven, Erik, Dinmohamed, Avinash G., Nijland, Marcel, Zwinderman, Aeilko H., Bossuyt, Patrick M., Veldhuis, Martine S., Rutten, Emma G. G. M., Mous, Rogier, Vermaat, Joost S. P., Sandberg, Yorick, de Jongh, Eva, Bilgin, Yavuz M., Boersma, Rinske, Koene, Harry, Kersten, Marie José, de Jong, Daphne, and Chamuleau, Martine E. D.

Published
2023
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8. Clinical outcomes of uninterrupted embryo culture with or without time-lapse-based embryo selection versus interrupted standard culture (SelecTIMO): a three-armed, multicentre, double-blind, randomised controlled trial

Author

Kieslinger, D C, Vergouw, C G, Ramos, L, Arends, B, Curfs, M H J M, Slappendel, E, Kostelijk, E H, Pieters, M H E C, Consten, D, Verhoeven, M O, Besselink, D E, Broekmans, F, Cohlen, B J, Smeenk, J M J, Mastenbroek, S, de Koning, C H, van Kasteren, Y M, Moll, E, van Disseldorp, J, Brinkhuis, E A, Kuijper, E A M, van Baal, W M, van Weering, H G I, van der Linden, P J Q, Gerards, M H, Bossuyt, P M, van Wely, M, and Lambalk, C B

Published
2023
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10. Reporting of Test Comparisons in Diagnostic Accuracy Studies: A Literature Review

Author

Vali, Yasaman, Yang, Bada, Olsen, Maria, Leeflang, Mariska M. G., and Bossuyt, Patrick M. M.

Abstract

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 comparative accuracy studies. We evaluated 100 comparative accuracy studies, published in 2015, 2016 or 2017, randomly sampled from 238 comparative accuracy systematic reviews. We extracted information on 20 reporting items, pertaining to the identification of the test comparison, its validity, and the actual results of the comparison. About a third of the studies (n = 36) did not report the comparison as a study objective or hypothesis. Although most studies (n = 86) reported how participants had been allocated to index tests, we could often not evaluate whether test interpreters had been blinded to the results of other index tests (n = 40; among 59 applicable studies), nor could we identify the sequence of index tests (n = 52; among 90 applicable studies) or the methods for comparing measures of accuracy (n = 59). Two-by-four table data (revealing the agreement between index tests) were only reported by 9 of 90 paired comparative studies. More than half of the studies (n = 64) did not provide measures of statistical imprecision for comparative accuracy. Our findings suggest that components of test comparisons are frequently missing or incompletely described in comparative accuracy studies included in systematic reviews. Explicit guidance for reporting comparative accuracy studies may facilitate the production of full and informative study reports.

Published
2021
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11. Variation in the observed effect of Xpert MTB/RIF testing for tuberculosis on mortality: A systematic review and analysis of trial design considerations

Author

Ochodo, Eleanor A, Kalema, Nelson, Schumacher, Samuel, Steingart, Karen, Young, Taryn, Mallett, Susan, Deeks, Jon, Cobelens, Frank, Bossuyt, Patrick M, Nicol, Mark P, and Cattamanchi, Adithya

Subjects
Health Services and Systems, Health Sciences, Emerging Infectious Diseases, Clinical Research, Tuberculosis, Biodefense, Clinical Trials and Supportive Activities, Infectious Diseases, Rare Diseases, Infection, Good Health and Well Being, Diagnostic trials, Impact studies, Tuberculosis diagnosis, methodology, Xpert MTB/RIF, Impact, Pragmatic trials, diagnostic trials, Methodology, Systematic review, Biomedical and clinical sciences, Health sciences
Abstract

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 to follow-up, thereby reducing the potential impact of Xpert MTB/RIF testing. Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Scopus for literature published from 1 st January 2009 to February 2019. We included all primary intervention studies that had evaluated the effect of Xpert MTB/RIF on mortality compared to usual care in participants with presumptive pulmonary TB. We critically reviewed features of included studies across: Study setting and context, Study population, Participant recruitment and enrolment, Study procedures, and Study follow-up. Results: We included seven randomised and one non-randomised study.  All included studies demonstrated relative reductions in overall mortality in the Xpert MTB/RIF arm ranging from 6% to 40%. However, mortality reduction was reported to be statistically significant in two studies. Study features that could explain the lack of observed effect on mortality included: the higher quality of care at study sites; inclusion of patients with a higher pre-test probability of TB leading to higher than expected empirical rates; performance of additional diagnostic testing not done in usual care leading to increased TB diagnosis or empiric treatment initiation; the recruitment of participants likely to return for follow-up; and involvement of study staff in ensuring adherence with care and follow-up. Conclusion: Most studies of Xpert MTB/RIF were designed and conducted in a manner that resulted in more patients being diagnosed and treated for TB, minimising the potential difference in mortality Xpert MTB/RIF testing could have achieved compared to usual care.

Published
2019

12. Searching Practices and Inclusion of Unpublished Studies in Systematic Reviews of Diagnostic Accuracy

Author

Korevaar, Daniël A., Salameh, Jean-Paul, Vali, Yasaman, Cohen, Jérémie F., McInnes, Matthew D. F., Spijker, René, and Bossuyt, Patrick M.

Abstract

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 accuracy. Methods: We extracted data from 100 non-Cochrane systematic reviews of diagnostic accuracy indexed in MEDLINE and published between October 2017 and January 2018 and from all 100 Cochrane systematic reviews of diagnostic accuracy published by December 2018, irrespective of whether meta-analysis had been performed. Results: Non-Cochrane and Cochrane reviews searched a median of 4 (IQR 3-5) and 6 (IQR 5-9) databases, respectively; most often MEDLINE/PubMed (n = 100 and n = 100) and EMBASE (n = 81 and n = 100). Additional efforts to identify studies beyond searching bibliographic databases were performed in 76 and 98 reviews, most often through screening reference lists (n = 71 and n = 96), review/guideline articles (n = 18 and n = 52), or citing articles (n = 3 and n = 42). Specific sources of unpublished studies were searched in 22 and 68 reviews, for example, conference proceedings (n = 4 and n = 18), databases only containing conference abstracts (n = 2 and n = 33), or trial registries (n = 12 and n = 39). At least one unpublished study was included in 17 and 23 reviews. Overall, 39 of 2082 studies (1.9%) included in non-Cochrane reviews were unpublished, and 64 of 2780 studies (2.3%) in Cochrane reviews, most often conference abstracts (97/103). Conclusion: Searching practices vary considerably across systematic reviews of diagnostic accuracy. Unpublished studies are a minimal fraction of the evidence included in recent reviews.

Published
2020
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14. A quality assessment tool for artificial intelligence-centered diagnostic test accuracy studies: QUADAS-AI

Author

Sounderajah, Viknesh, Ashrafian, Hutan, Rose, Sherri, Shah, Nigam H., Ghassemi, Marzyeh, Golub, Robert, Kahn, Jr, Charles E., Esteva, Andre, Karthikesalingam, Alan, Mateen, Bilal, Webster, Dale, Milea, Dan, Ting, Daniel, Treanor, Darren, Cushnan, Dominic, King, Dominic, McPherson, Duncan, Glocker, Ben, Greaves, Felix, Harling, Leanne, Ordish, Johan, Cohen, Jérémie F., Deeks, Jon, Leeflang, Mariska, Diamond, Matthew, McInnes, Matthew D. F., McCradden, Melissa, Abràmoff, Michael D., Normahani, Pasha, Markar, Sheraz R., Chang, Stephanie, Liu, Xiaoxuan, Mallett, Susan, Shetty, Shravya, Denniston, Alastair, Collins, Gary S., Moher, David, Whiting, Penny, Bossuyt, Patrick M., and Darzi, Ara

Published
2021
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18. Kritisch beoordelen van een artikel over primair onderzoek

Author

Offringa, M., Assendelft, W. J. J., Scholten, R. J. P. M., Leeflang, M. M. G., Bossuyt, P. M. M., Groenwold, R. H. H., Reitsma, J. B., van de Laar, F. A., van Puijenbroek, E. P., Broeders, M. J. M., van der Graaf, Y., Terwee, C. B., de Vet, H. C. W., Lucassen, P. L. B. J., Reis, R., Dees, M., Scholten, R.J.P.M., editor, Offringa, M., editor, and Assendelft, W.J.J., editor

Published
2018
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24. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews

Author

Page, Matthew J., McKenzie, Joanne E., Bossuyt, Patrick M., Boutron, Isabelle, Hoffmann, Tammy C., Mulrow, Cynthia D., Shamseer, Larissa, Tetzlaff, Jennifer M., Akl, Elie A., Brennan, Sue E., Chou, Roger, Glanville, Julie, Grimshaw, Jeremy M., Hróbjartsson, Asbjørn, Lalu, Manoj M., Li, Tianjing, Loder, Elizabeth W., Mayo-Wilson, Evan, McDonald, Steve, McGuinness, Luke A., Stewart, Lesley A., Thomas, James, Tricco, Andrea C., Welch, Vivian A., Whiting, Penny, and Moher, David

Published
2021
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32. P-293 Is time-lapse monitoring a safe alternative? Obstetric and neonatal outcomes of a multicenter randomized controlled trial

Author

Kieslinger, D C, primary, Vergouw, C G, additional, Von Estorff, F, additional, Ramos, L, additional, Arends, B, additional, Curfs, M H J M, additional, Slappendel, E, additional, Kostelijk, E H, additional, Pieters, M H E C, additional, Consten, D, additional, Verhoeven, M O, additional, Besselink, D E, additional, Broekmans, F, additional, Cohlen, B J, additional, Smeenk, J M J, additional, Mastenbroek, S, additional, De Koning, C H, additional, Van Kasteren, Y M, additional, Moll, E, additional, Van Disseldorp, J, additional, Brinkhuis, E A, additional, Kuijper, E A M, additional, Van Baal, W M, additional, Van Weering, H G I, additional, Van der Linden, P J Q, additional, Gerards, M H, additional, Bossuyt, P M, additional, Van Wely, M, additional, and Lambalk, C B, additional

Published
2023
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33. Clinical outcomes of uninterrupted embryo culture with or without time-lapse-based embryo selection versus interrupted standard culture (SelecTIMO): a three-armed, multicentre, double-blind, randomised controlled trial

Author

Research UMC Utrecht, Functieafdeling Fertiliteit/IVF, MS VPG/Gynaecologie, Child Health, Kieslinger, D. C., Vergouw, C. G., Ramos, L., Arends, B., Curfs, M. H.J.M., Slappendel, E., Kostelijk, E. H., Pieters, M. H.E.C., Consten, D., Verhoeven, M. O., Besselink, D. E., Broekmans, F., Cohlen, B. J., Smeenk, J. M.J., Mastenbroek, S., de Koning, C. H., van Kasteren, Y. M., Moll, E., van Disseldorp, J., Brinkhuis, E. A., Kuijper, E. A.M., van Baal, W. M., van Weering, H. G.I., van der Linden, P. J.Q., Gerards, M. H., Bossuyt, P. M., van Wely, M., Lambalk, C. B., Research UMC Utrecht, Functieafdeling Fertiliteit/IVF, MS VPG/Gynaecologie, Child Health, Kieslinger, D. C., Vergouw, C. G., Ramos, L., Arends, B., Curfs, M. H.J.M., Slappendel, E., Kostelijk, E. H., Pieters, M. H.E.C., Consten, D., Verhoeven, M. O., Besselink, D. E., Broekmans, F., Cohlen, B. J., Smeenk, J. M.J., Mastenbroek, S., de Koning, C. H., van Kasteren, Y. M., Moll, E., van Disseldorp, J., Brinkhuis, E. A., Kuijper, E. A.M., van Baal, W. M., van Weering, H. G.I., van der Linden, P. J.Q., Gerards, M. H., Bossuyt, P. M., van Wely, M., and Lambalk, C. B.

Published
2023

34. Developing specific reporting guidelines for diagnostic accuracy studies assessing AI interventions: The STARD-AI Steering Group

Author

Sounderajah, Viknesh, Ashrafian, Hutan, Aggarwal, Ravi, De Fauw, Jeffrey, Denniston, Alastair K., Greaves, Felix, Karthikesalingam, Alan, King, Dominic, Liu, Xiaoxuan, Markar, Sheraz R., McInnes, Matthew D. F., Panch, Trishan, Pearson-Stuttard, Jonathan, Ting, Daniel S. W., Golub, Robert M., Moher, David, Bossuyt, Patrick M., and Darzi, Ara

Published
2020
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37. Performance of non-invasive tests and histology for the prediction of clinical outcomes in patients with non-alcoholic fatty liver disease: an individual participant data meta-analysis

Author

Mózes, Ferenc E, Lee, Jenny A, Vali, Yasaman, Alzoubi, Osama, Staufer, Katharina, Trauner, Michael, Paternostro, Rafael, Stauber, Rudolf E, Holleboom, Adriaan G, van Dijk, Anne-Marieke, Mak, Anne Linde, Boursier, Jérôme, de Saint Loup, Marc, Shima, Toshihide, Bugianesi, Elisabetta, Gaia, Silvia, Armandi, Angelo, Shalimar, Lupșor-Platon, Monica, Wong, Vincent Wai-Sun, Li, Guanlin, Wong, Grace Lai-Hung, Cobbold, Jeremy, Karlas, Thomas, Wiegand, Johannes, Sebastiani, Giada, Tsochatzis, Emmanuel, Liguori, Antonio, Yoneda, Masato, Nakajima, Atsushi, Hagström, Hannes, Akbari, Camilla, Hirooka, Masashi, Chan, Wah-Kheong, Mahadeva, Sanjiv, Rajaram, Ruveena, Zheng, Ming-Hua, George, Jacob, Eslam, Mohammed, Petta, Salvatore, Pennisi, Grazia, Viganò, Mauro, Ridolfo, Sofia, Aithal, Guruprasad Padur, Palaniyappan, Naaventhan, Lee, Dae Ho, Ekstedt, Mattias, Nasr, Patrik, Cassinotto, Christophe, de Lédinghen, Victor, Berzigotti, Annalisa, Mendoza, Yuly P, Noureddin, Mazen, Truong, Emily, Fournier-Poizat, Céline, Geier, Andreas, Martic, Miljen, Tuthill, Theresa, Anstee, Quentin M, Harrison, Stephen A, Bossuyt, Patrick M, Pavlides, Michael, Anstee, Quentin M, Daly, Ann K, Govaere, Olivier, Cockell, Simon, Tiniakos, Dina, Bedossa, Pierre, Burt, Alastair, Oakley, Fiona, Cordell, Heather J, Day, Christopher P, Wonders, Kristy, Missier, Paolo, McTeer, Matthew, Vale, Luke, Oluboyede, Yemi, Breckons, Matt, Bossuyt, Patrick M, Zafarmand, Hadi, Vali, Yasaman, Lee, Jenny, Nieuwdorp, Max, Holleboom, Adriaan G, Verheij, Joanne, Ratziu, Vlad, Clément, Karine, Patino-Navarrete, Rafael, Pais, Raluca, Paradis, Valerie, Schuppan, Detlef, Schattenberg, Jörn M, Surabattula, Rambabu, Myneni, Sudha, Straub, Beate K, Vidal-Puig, Toni, Vacca, Michele, Rodrigues-Cuenca, Sergio, Allison, Mike, Kamzolas, Ioannis, Petsalaki, Evangelia, Campbell, Mark, Lelliott, Chris J, Davies, Susan, Orešič, Matej, Hyötyläinen, Tuulia, McGlinchey, Aiden, Mato, Jose M, Millet, Óscar, Dufour, Jean-François, Berzigotti, Annalisa, Masoodi, Mojgan, Pavlides, Michael, Harrison, Stephen, Neubauer, Stefan, Cobbold, Jeremy, Mozes, Ferenc, Akhtar, Salma, Olodo-Atitebi, Seliat, Banerjee, Rajarshi, Kelly, Matt, Shumbayawonda, Elizabeth, Dennis, Andrea, Andersson, Anneli, Wigley, Ioan, Romero-Gómez, Manuel, Gómez-González, Emilio, Ampuero, Javier, Castell, Javier, Gallego-Durán, Rocío, Fernández, Isabel, Montero-Vallejo, Rocío, Karsdal, Morten, Rasmussen, Daniel Guldager Kring, Leeming, Diana Julie, Sinisi, Antonia, Musa, Kishwar, Sandt, Estelle, Tonini, Manuela, Bugianesi, Elisabetta, Rosso, Chiara, Armandi, Angelo, Marra, Fabio, Gastaldelli, Amalia, Svegliati, Gianluca, Boursier, Jérôme, Francque, Sven, Vonghia, Luisa, Driessen, Ann, Ekstedt, Mattias, Kechagias, Stergios, Yki-Järvinen, Hannele, Porthan, Kimmo, Arola, Johanna, van Mil, Saskia, Papatheodoridis, George, Cortez-Pinto, Helena, Rodrigues, Cecilia M P, Valenti, Luca, Pelusi, Serena, Petta, Salvatore, Pennisi, Grazia, Miele, Luca, Geier, Andreas, Trautwein, Christian, Reißing, Johanna, Aithal, Guruprasad P, Francis, Susan, Palaniyappan, Naaventhan, Bradley, Christopher, Hockings, Paul, Schneider, Moritz, Newsome, Philip, Hübscher, Stefan, Wenn, David, Rosenquist, Christian, Trylesinski, Aldo, Mayo, Rebeca, Alonso, Cristina, Duffin, Kevin, Perfield, James W, Chen, Yu, Yunis, Carla, Tuthill, Theresa, Harrington, Magdalena Alicia, Miller, Melissa, Chen, Yan, McLeod, Euan James, Ross, Trenton, Bernardo, Barbara, Schölch, Corinna, Ertle, Judith, Younes, Ramy, Oldenburger, Anouk, Coxson, Harvey, Ostroff, Rachel, Alexander, Leigh, Biegel, Hannah, Kjær, Mette Skalshøi, Harder, Lea Mørch, Davidsen, Peter, Ellegaard, Jens, Balp, Maria-Magdalena, Brass, Clifford, Jennings, Lori, Martic, Miljen, Löffler, Jürgen, Applegate, Douglas, Shankar, Sudha, Torstenson, Richard, Lindén, Daniel, Fournier-Poizat, Céline, Llorca, Anne, Kalutkiewicz, Michael, Pepin, Kay, Ehman, Richard, Horan, Gerald, Ho, Gideon, Tai, Dean, Chng, Elaine, Patterson, Scott D, Billin, Andrew, Doward, Lynda, Twiss, James, Thakker, Paresh, Derdak, Zoltan, Landgren, Henrik, Lackner, Carolin, Gouw, Annette, and Hytiroglou, Prodromos

Abstract

Histologically assessed liver fibrosis stage has prognostic significance in patients with non-alcoholic fatty liver disease (NAFLD) and is accepted as a surrogate endpoint in clinical trials for non-cirrhotic NAFLD. Our aim was to compare the prognostic performance of non-invasive tests with liver histology in patients with NAFLD.

Published
2023
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39. Prevention of multiple pregnancies in couples with unexplained or mild male subfertility : randomised controlled trial of in vitro fertilisation with single embryo transfer or in vitro fertilisation in modified natural cycle compared with intrauterine insemination with controlled ovarian hyperstimulation

Author

Bensdorp, A J, Tjon-Kon-Fat, R I, Bossuyt, P M M, Koks, C A M, Oosterhuis, G J E, Hoek, A, Hompes, P G A, Broekmans, F J M, Verhoeve, H R, de Bruin, J P, van Golde, R, Repping, S, Cohlen, B J, Lambers, M D A, van Bommel, P F, Slappendel, E, Perquin, D, Smeenk, J M, Pelinck, M J, Gianotten, J, Hoozemans, D A, Maas, J W M, Eijkemans, M J C, van der Veen, F, Mol, B W J, and van Wely, M

Published
2015

40. Cost-effectiveness of Diagnostic Testing Strategies Including Cervical-Length Measurement and Fibronectin Testing in Women With Symptoms of Preterm Labor

Author

van Baaren, G.-J., Vis, J. Y., Wilms, F. F., Oudijk, M. A., Kwee, A., Porath, M. M., Scheepers, H. C. J., Spaanderman, M. E. A., Bloemenkamp, K. W. M., Haak, M. C., Bax, C. J., Cornette, J. M. J., Duvekot, J. J., Nij Bijvanck, B. W. A., van Eyck, J., Franssen, M. T. M., Sollie, K. M., Vandenbussche, F. P. H. A., Woiski, M., Bolte, A. C., van der Post, J. A. M., Bossuyt, P. M. M., Opmeer, B. C., and Mol, B. W. J.

Published
2018
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44. OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest X-ray or ultra-low-dose CT (OPTIMACT)—a randomised controlled trial chest X-ray or ultra-low-dose CT at the ED: design and rationale

Author

van den Berk, Inge A. H., Kanglie, Maadrika M. N. P., van Engelen, Tjitske S. R., Bipat, Shandra, Dijkgraaf, Marcel G. W., Bossuyt, Patrick M. M., de Monyé, Wouter, Prins, Jan M., and Stoker, Jaap

Published
2018
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46. The FOAM study: is Hysterosalpingo foam sonography (HyFoSy) a cost-effective alternative for hysterosalpingography (HSG) in assessing tubal patency in subfertile women? Study protocol for a randomized controlled trial

Author

van Rijswijk, Joukje, van Welie, Nienke, Dreyer, Kim, van Hooff, Machiel H. A., de Bruin, Jan Peter, Verhoeve, Harold R., Mol, Femke, Kleiman-Broeze, Kimiko A., Traas, Maaike A. F., Muijsers, Guido J. J. M., Manger, Arentje P., Gianotten, Judith, de Koning, Cornelia H., Koning, Aafke M. H., Bayram, Neriman, van der Ham, David P., Vrouenraets, Francisca P. J. M., Kalafusova, Michaela, van de Laar, Bob I. G., Kaijser, Jeroen, van Oostwaard, Miriam F., Meijer, Wouter J., Broekmans, Frank J. M., Valkenburg, Olivier, van der Voet, Lucy F., van Disseldorp, Jeroen, Lambers, Marieke J., Peters, Henrike E., Lier, Marit C. I., Lambalk, Cornelis B., van Wely, Madelon, Bossuyt, Patrick M. M., Stoker, Jaap, van der Veen, Fulco, Mol, Ben W. J., and Mijatovic, Velja

Published
2018
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47. Waarom ik?: Over risico en toeval bij ziekte

Author

Bossuyt, P M M, Epidemiology and Data Science, APH - Methodology, and APH - Personalized Medicine

Subjects
Mental Health, Narration, Humans
Abstract

In explaining why a patient has been struck with disease, health care professionals may turn to arguments from epidemiology, pointing to risk factors from lifestyle, diet, or genetics. Yet many patients build detailed narratives on why and when disease and illness overcame them. They can point to specific behaviors, of themselves or others, to stress, or fate. Such stories and health beliefs can help patients preserve mental health in the context of life-threatening diagnoses but stories can also be protective of physical health. There seems to be little room for "chance" in these narratives, which illustrates the apparent disparity between probabilistic descriptions and patients' need for explanations and meaning. Recent pleas for evidentiary pluralism and narrative-based medicine aim at closing this gap.

Published
2022

48. Diagnostic accuracy of non-invasive tests for advanced fibrosis in patients with NAFLD: An individual patient data meta-analysis

Author

Mozes, F. E., Lee, J. A., Selvaraj, E. A., Jayaswal, A. N. A., Trauner, M., Boursier, J., Fournier, C., Staufer, K., Stauber, R. E., Bugianesi, E., Younes, R., Gaia, S., Lupsor-Platon, M., Petta, S., Shima, T., Okanoue, T., Mahadeva, S., Chan, W. -K., Eddowes, P. J., Newsome, P. N., Wong, V. W. -S., de Ledinghen, V., Fan, J., Shen, F., Cobbold, J. F., Sumida, Y., Okajima, A., Schattenberg, J. M., Labenz, C., Kim, W., Lee, M. S., Wiegand, J., Karlas, T., Yilmaz, Y., Aithal, G. P., Palaniyappan, N., Cassinotto, C., Aggarwal, S., Garg, H., Ooi, G. J., Nakajima, A., Yoneda, M., Ziol, M., Barget, N., Geier, A., Tuthill, T., Brosnan, M. J., Anstee, Q. M., Neubauer, S., Harrison, S. A., Bossuyt, P. M., Pavlides, M., Anstee, Q., Daly, A., Johnson, K., Govaere, O., Cockell, S., Tiniakos, D., Bedossa, P., Oakley, F., Cordell, H., Day, C., Wonders, K., Bossuyt, P., Zafarmand, H., Vali, Y., Lee, J., Ratziu, V., Clement, K., Pais, R., Schuppan, D., Schattenberg, J., Vidal-Puig, T., Vacca, M., Rodrigues-Cuenca, S., Allison, M., Kamzolas, I., Petsalaki, E., Oresic, M., Hyotylainen, T., Mcglinchey, A., Mato, J. M., Millet, O., Dufour, J. -F., Berzigotti, A., Harrison, S., Cobbold, J., Mozes, F., Akhtar, S., Banerjee, R., Kelly, M., Shumbayawonda, E., Dennis, A., Erpicum, C., Graham, M., Romero-Gomez, M., Gomez-Gonzalez, E., Ampuero, J., Castell, J., Gallego-Duran, R., Fernandez, I., Montero-Vallejo, R., Karsdal, M., Erhardtsen, E., Rasmussen, D., Leeming, D. J., Fisker, M. J., Sinisi, A., Musa, K., Betsou, F., Sandt, E., Tonini, M., Rosso, C., Armandi, A., Marra, F., Gastaldelli, A., Svegliati, G., Francque, S., Vonghia, L., Ekstedt, M., Kechagias, S., Yki-Jarvinen, H., Porthan, K., van Mil, S., Papatheodoridis, G., Cortez-Pinto, H., Valenti, L., Miele, Luca, Trautwein, C., Aithal, G., Hockings, P., Newsome, P., Wenn, D., Rodrigues, C. M. P., Chaumat, P., Hanf, R., Trylesinski, A., Ortiz, P., Duffin, K., Brosnan, J., Mcleod, E., Ertle, J., Ostroff, R., Alexander, L., Kjaer, M. S., Mikkelsen, L. F., Balp, M. -M., Brass, C., Jennings, L., Martic, M., Loeffler, J., Hanauer, G., Shankar, S., Pepin, K., Ehman, R., Myers, J., Ho, G., Torstenson, R., Myers, R., Doward, L., Miele L. (ORCID:0000-0003-3464-0068), Mozes, F. E., Lee, J. A., Selvaraj, E. A., Jayaswal, A. N. A., Trauner, M., Boursier, J., Fournier, C., Staufer, K., Stauber, R. E., Bugianesi, E., Younes, R., Gaia, S., Lupsor-Platon, M., Petta, S., Shima, T., Okanoue, T., Mahadeva, S., Chan, W. -K., Eddowes, P. J., Newsome, P. N., Wong, V. W. -S., de Ledinghen, V., Fan, J., Shen, F., Cobbold, J. F., Sumida, Y., Okajima, A., Schattenberg, J. M., Labenz, C., Kim, W., Lee, M. S., Wiegand, J., Karlas, T., Yilmaz, Y., Aithal, G. P., Palaniyappan, N., Cassinotto, C., Aggarwal, S., Garg, H., Ooi, G. J., Nakajima, A., Yoneda, M., Ziol, M., Barget, N., Geier, A., Tuthill, T., Brosnan, M. J., Anstee, Q. M., Neubauer, S., Harrison, S. A., Bossuyt, P. M., Pavlides, M., Anstee, Q., Daly, A., Johnson, K., Govaere, O., Cockell, S., Tiniakos, D., Bedossa, P., Oakley, F., Cordell, H., Day, C., Wonders, K., Bossuyt, P., Zafarmand, H., Vali, Y., Lee, J., Ratziu, V., Clement, K., Pais, R., Schuppan, D., Schattenberg, J., Vidal-Puig, T., Vacca, M., Rodrigues-Cuenca, S., Allison, M., Kamzolas, I., Petsalaki, E., Oresic, M., Hyotylainen, T., Mcglinchey, A., Mato, J. M., Millet, O., Dufour, J. -F., Berzigotti, A., Harrison, S., Cobbold, J., Mozes, F., Akhtar, S., Banerjee, R., Kelly, M., Shumbayawonda, E., Dennis, A., Erpicum, C., Graham, M., Romero-Gomez, M., Gomez-Gonzalez, E., Ampuero, J., Castell, J., Gallego-Duran, R., Fernandez, I., Montero-Vallejo, R., Karsdal, M., Erhardtsen, E., Rasmussen, D., Leeming, D. J., Fisker, M. J., Sinisi, A., Musa, K., Betsou, F., Sandt, E., Tonini, M., Rosso, C., Armandi, A., Marra, F., Gastaldelli, A., Svegliati, G., Francque, S., Vonghia, L., Ekstedt, M., Kechagias, S., Yki-Jarvinen, H., Porthan, K., van Mil, S., Papatheodoridis, G., Cortez-Pinto, H., Valenti, L., Miele, Luca, Trautwein, C., Aithal, G., Hockings, P., Newsome, P., Wenn, D., Rodrigues, C. M. P., Chaumat, P., Hanf, R., Trylesinski, A., Ortiz, P., Duffin, K., Brosnan, J., Mcleod, E., Ertle, J., Ostroff, R., Alexander, L., Kjaer, M. S., Mikkelsen, L. F., Balp, M. -M., Brass, C., Jennings, L., Martic, M., Loeffler, J., Hanauer, G., Shankar, S., Pepin, K., Ehman, R., Myers, J., Ho, G., Torstenson, R., Myers, R., Doward, L., and Miele L. (ORCID:0000-0003-3464-0068)

Abstract

Objective Liver biopsy is still needed for fibrosis staging in many patients with non-alcoholic fatty liver disease. The aims of this study were to evaluate the individual diagnostic performance of liver stiffness measurement by vibration controlled transient elastography (LSM-VCTE), Fibrosis-4 Index (FIB-4) and NAFLD (non-alcoholic fatty liver disease) Fibrosis Score (NFS) and to derive diagnostic strategies that could reduce the need for liver biopsies. Design Individual patient data meta-analysis of studies evaluating LSM-VCTE against liver histology was conducted. FIB-4 and NFS were computed where possible. Sensitivity, specificity and area under the receiver operating curve (AUROC) were calculated. Biomarkers were assessed individually and in sequential combinations. Results Data were included from 37 primary studies (n=5735; 45% women; median age: 54 years; median body mass index: 30 kg/m2; 33% had type 2 diabetes; 30% had advanced fibrosis). AUROCs of individual LSM-VCTE, FIB-4 and NFS for advanced fibrosis were 0.85, 0.76 and 0.73. Sequential combination of FIB-4 cut-offs (<1.3; ≥2.67) followed by LSM-VCTE cut-offs (<8.0; ≥10.0 kPa) to rule-in or rule-out advanced fibrosis had sensitivity and specificity (95% CI) of 66% (63-68) and 86% (84-87) with 33% needing a biopsy to establish a final diagnosis. FIB-4 cut-offs (<1.3; ≥3.48) followed by LSM cut-offs (<8.0; ≥20.0 kPa) to rule out advanced fibrosis or rule in cirrhosis had a sensitivity of 38% (37-39) and specificity of 90% (89-91) with 19% needing biopsy. Conclusion Sequential combinations of markers with a lower cut-off to rule-out advanced fibrosis and a higher cut-off to rule-in cirrhosis can reduce the need for liver biopsies.

Published
2022

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