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1. Community Use of Repurposed Drugs Before and During COVID-19 Pandemic in the Netherlands: An Interrupted Time-Series Analysis

Author

Zhou G, de Vos S, Schuiling-Veninga CC, Bos J, Oude Rengerink K, Pasmooij AMG, Mol PG, de Bock GH, and Hak E

Subjects
covid-19, drug utilization, repurposed drug, stringency index, Infectious and parasitic diseases, RC109-216
Abstract

Guiling Zhou,1 Stijn de Vos,1 Catharina CM Schuiling-Veninga,1 Jens Bos,1 Katrien Oude Rengerink,2 Anna Maria Gerdina Pasmooij,2 Peter GM Mol,2,3 Geertruida H de Bock,4 Eelko Hak1 1Unit of Pharmaco-Therapy, -Epidemiology and -Economics (PTEE), Department of Pharmacy, University of Groningen, Groningen, the Netherlands; 2Medicines Evaluation Board, Utrecht, the Netherlands; 3Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands; 4Department of Epidemiology, University Medical Center Groningen, University of Groningen, Groningen, the NetherlandsCorrespondence: Guiling Zhou, Unit of Pharmaco-Therapy, -Epidemiology and -Economics (PTEE), Department of Pharmacy, University of Groningen, Antonius Deusinglaan 1, Groningen, 9713 AV, the Netherlands, Tel +31 503638707, Fax +31 503632772, Email g.zhou@rug.nlBackground: Repurposing registered drugs could reduce coronavirus disease (COVID-19) burden before novel drugs are authorized. Little is known about how the pandemic and imposed restrictions changed their dispensing. We aimed to investigate the impact of COVID-19 pandemic on repurposed drugs dispensing in the Netherlands.Methods: We performed interrupted time-series study using University of Groningen prescription database IADB.nl to evaluate dispensing trends of 24 repurposed drugs before (2017-February 2020) and after (March 2020– 2021) the pandemic’ start. Primary outcomes were monthly prevalence and incidence rates. An autoregressive integrated moving average model assessed the effect of pandemic and stringency index (measuring strictness of government’s restriction policies).Results: Annual number of IADB.nl population ranged from 919,697 to 952,400. Generally, dispensing of common long-term-used drugs was not significantly affected by pandemic. The prevalence of antibacterials (− 4.20 users per 1000 people), antivirals (− 0.04), corticosteroids (− 1.29), prednisolone (− 1.32), calcium channel blocker (− 0.41), and diuretics (− 1.29) was lower than expected after the pandemic’s start, while the prevalence of ivermectin (0.07), sulfonylureas (0.15), sodium-glucose co-transporter-2 (SGLT2) inhibitor (0.17), and anticoagulants (1.95) was higher than expected. The pandemic was associated with statistically significant decreases in the incidence of antibacterials (− 1.21), corticosteroids (− 0.60), prednisolone (− 0.64) and anticoagulants (− 0.02), and increases in ivermectin (0.02), aggregated antidiabetic drugs (0.13), and SGLT2 inhibitors (0.06). These trends were positively associated with pandemic and negatively associated with stringency index.Conclusion: Dispensing of most drugs was not significantly associated with pandemic and government’s response. Despite some statistically significant disruptions, these were not necessarily clinically relevant due to small absolute differences observed.Keywords: COVID-19, drug utilization, repurposed drug, stringency index

Published
2023

5. Analysing the protection from respiratory tract infections and allergic diseases early in life by human milk components: the PRIMA birth cohort

Author

Stigt, A.H. van, Oude Rengerink, K., Bloemenkamp, K.W.M., Waal, W. de, Prevaes, S.M.P.J., Le, T., Wijk, F van, Nederend, M., Hellinga, A.H., Lammers, C.S., Hartog, G. den, Herwijnen, M.J.C. van, Garssen, J., Knippels, L.M., Verhagen, L.M., Theije, C.G.M. de, Lopez-Rincon, A., Leusen, J.H.W., Land, B. van't, Bont, L., Stigt, A.H. van, Oude Rengerink, K., Bloemenkamp, K.W.M., Waal, W. de, Prevaes, S.M.P.J., Le, T., Wijk, F van, Nederend, M., Hellinga, A.H., Lammers, C.S., Hartog, G. den, Herwijnen, M.J.C. van, Garssen, J., Knippels, L.M., Verhagen, L.M., Theije, C.G.M. de, Lopez-Rincon, A., Leusen, J.H.W., Land, B. van't, and Bont, L.

Abstract

Contains fulltext : 248845.pdf (Publisher’s version ) (Open Access)

Published
2022

6. Estimation of treatment effects in short-term depression studies. An evaluation based on the ICH E9(R1) estimands framework

Author

Mitroiu, M., Teerenstra, S., Oude Rengerink, K., Pétavy, F., Roes, K.C.B., Mitroiu, M., Teerenstra, S., Oude Rengerink, K., Pétavy, F., and Roes, K.C.B.

Abstract

Contains fulltext : 283289.pdf (Publisher’s version ) (Open Access), Estimands aim to incorporate intercurrent events in design, data collection and estimation of treatment effects in clinical trials. Our aim was to understand what estimands may correspond to efficacy analyses commonly employed in clinical trials conducted before publication of ICH E9(R1). We re-analysed six clinical trials evaluating a new anti-depression treatment. We selected the following analysis methods-ANCOVA on complete cases, following last observation carried forward (LOCF) imputation and following multiple imputation; mixed-models for repeated measurements without imputation (MMRM), MMRM following LOCF imputation and following jump-to-reference imputation; and pattern-mixture mixed models. We included a principal stratum analysis based on the predicted subset of the study population who would not discontinue due to adverse events or lack of efficacy. We translated each analysis into the implicitly targeted estimand, and formulated corresponding clinical questions. We could map six estimands to analysis methods. The same analysis method could be mapped to more than one estimand. The major difference between estimands was the strategy for intercurrent events, with other attributes mostly the same across mapped estimands. The quantitative differences in MADRS10 population-level summaries between the estimands were 4-8 points. Not all six estimands had a clinically meaningful interpretation. Only a few analyses would target the same estimand, hence only few could be used as sensitivity analyses. The fact that an analysis could estimate different estimands emphasises the importance of prospectively defining the estimands targeting the primary objective of a trial. The fact that an estimand can be targeted by different analyses emphasises the importance of prespecifying precisely the estimator for the targeted estimand.

Published
2022

10. The GetReal Trial Tool: design, assess and discuss clinical drug trials in light of Real World Evidence generation

Author

Zuidgeest, MGP, Goetz, I, Meinecke, AK, Boateng, D, Irving, EA, Van Thiel, GJM, Welsing, PMJ, Oude-Rengerink, K, and Grobee, DE

Subjects
Real-world evidence, Clinical trial, Research design, Epidemiology, Medical ethics, Pragmatic trial
Abstract

Methodologies incorporating Real World Elements into clinical trial design (also called pragmatic trials) offer an attractive opportunity to assess the effect of a treatment strategy in routine care and as such guide decision making in practice. Uptake of these methods is slow for several reasons, including uncertainty about acceptability of trial results, lack of experience with the methodology and operational challenges. We developed the “GetReal Trial Tool,” an easy-to-use online interface, which allows users to assess the impact of design choices on generalizability to routine clinical practice, while taking into account risk of bias, precision, acceptability and operational feasibility. The tool is grounded in the scientific literature combined with knowledge of experts from academia, pharmaceutical companies, HTA bodies, patient organizations, and regulators. The aim is to help researchers optimize trial design and facilitate translation of evidence from pragmatic trials to clinical practice. In this paper we describe the development, structure and application of the GetReal Trial Tool.

Published
2022

11. Burden of respiratory syncytial virus bronchiolitis on the Dutch pediatric intensive care units

Author

Linssen, R.S., Bem, R.A., Kapitein, B., Oude Rengerink, K., Otten, M.H., Hollander, B., Verlaat, C.W., Bont, L., Woensel, J.B. van, Linssen, R.S., Bem, R.A., Kapitein, B., Oude Rengerink, K., Otten, M.H., Hollander, B., Verlaat, C.W., Bont, L., and Woensel, J.B. van

Abstract

Item does not contain fulltext, Respiratory syncytial virus (RSV) bronchiolitis causes substantial morbidity and mortality in young children, but insight into the burden of RSV bronchiolitis on pediatric intensive care units (PICUs) is limited. We aimed to determine the burden of RSV bronchiolitis on the PICUs in the Netherlands. Therefore, we identified all children ≤ 24 months of age with RSV bronchiolitis between 2003 and 2016 from a nationwide PICU registry. Subsequently we manually checked their patient records for correct diagnosis and collected patient characteristics, additional clinical data, respiratory support modes, and outcome. In total, 2161 children were admitted to the PICU for RSV bronchiolitis. The annual number of admissions increased significantly during the study period (β 4.05, SE 1.27, p = 0.01), and this increase was mostly driven by increased admissions in children up to 3 months old. Concomitantly, non-invasive respiratory support significantly increased (β 7.71, SE 0.92, p < 0.01), in particular the use of high flow nasal cannula (HFNC) (β 6.69, SE 0.96, p < 0.01), whereas the use of invasive ventilation remained stable.Conclusion: The burden of severe RSV bronchiolitis on PICUs has increased in the Netherlands. Concomitantly, the use of non-invasive respiratory support, especially HFNC, has increased. What is Known: • RSV bronchiolitis is a major cause of childhood morbidity and mortality and may require pediatric intensive care unit admission. • The field of pediatric critical care for severe bronchiolitis has changed due to increased non-invasive respiratory support options. What is New: • The burden of RSV bronchiolitis for the Dutch PICUs has increased. These data inform future strategic PICU resource planning and implementation of RSV preventive strategies. • There was a significant increase in the use of high flow nasal cannula at the PICU, but the use of invasive mechanical ventilation did not decrease.

Published
2021

15. Rethinking the intention-to-treat principle: one size does not fit all

Author

CTM & Statistical consultation, Biostatistiek Onderzoek, Oude Rengerink, K, Mitroiu, M, Teerenstra, S, Pétavy, F, Roes, K C B, CTM & Statistical consultation, Biostatistiek Onderzoek, Oude Rengerink, K, Mitroiu, M, Teerenstra, S, Pétavy, F, and Roes, K C B

Published
2020

17. Cost-effectiveness of induction of labour at term with a Foley catheter compared to vaginal prostaglandin E2 gel (PROBAAT trial)

Author

van Baaren, G J, Jozwiak, M, Opmeer, B C, Oude Rengerink, K, Benthem, M, Dijksterhuis, M GK, van Huizen, M E, van der Salm, P CM, Schuitemaker, N WE, Papatsonis, D NM, Perquin, D AM, Porath, M, van der Post, J AM, Rijnders, R JP, Scheepers, H CJ, Spaanderman, M, van Pampus, M G, de Leeuw, J W, Mol, B WJ, and Bloemenkamp, K WM

Published
2013
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22. Comparing induction of labour with oral misoprostol or Foley catheter at term : cost-effectiveness analysis of a randomised controlled multi-centre non-inferiority trial

Author

ten Eikelder, M. L.G., van Baaren, G. J., Oude Rengerink, K., Jozwiak, M., de Leeuw, J. W., Kleiverda, G., Evers, I., de Boer, K., Brons, J., Bloemenkamp, K. W.M., Mol, B. W., ten Eikelder, M. L.G., van Baaren, G. J., Oude Rengerink, K., Jozwiak, M., de Leeuw, J. W., Kleiverda, G., Evers, I., de Boer, K., Brons, J., Bloemenkamp, K. W.M., and Mol, B. W.

Published
2018

23. Comparing induction of labour with oral misoprostol or Foley catheter at term: cost-effectiveness analysis of a randomised controlled multi-centre non-inferiority trial

Author

CTM & Statistical consultation, Circulatory Health, JC onderzoeksprogramma Methodologie, Geboortecentrum voorzitterschap, ten Eikelder, M. L.G., van Baaren, G. J., Oude Rengerink, K., Jozwiak, M., de Leeuw, J. W., Kleiverda, G., Evers, I., de Boer, K., Brons, J., Bloemenkamp, K. W.M., Mol, B. W., CTM & Statistical consultation, Circulatory Health, JC onderzoeksprogramma Methodologie, Geboortecentrum voorzitterschap, ten Eikelder, M. L.G., van Baaren, G. J., Oude Rengerink, K., Jozwiak, M., de Leeuw, J. W., Kleiverda, G., Evers, I., de Boer, K., Brons, J., Bloemenkamp, K. W.M., and Mol, B. W.

Published
2018

24. MisoREST: Surgical versus expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for miscarriage: A cohort study

Author

Lemmers, M., Verschoor, M.A., Oude Rengerink, K., Naaktgeboren, C., Bossuyt, P.M., Huirne, J.A., Janssen, I.A.W., Radder, C., Klinkert, E.R., Langenveld, J., Voet, L. Van der, Siemens, F.F., Bongers, M.Y., Hooff, M.H. van, Ploeg, M., Coppus, S.F.P.J., Ankum, W.M., Mol, B.W., Lemmers, M., Verschoor, M.A., Oude Rengerink, K., Naaktgeboren, C., Bossuyt, P.M., Huirne, J.A., Janssen, I.A.W., Radder, C., Klinkert, E.R., Langenveld, J., Voet, L. Van der, Siemens, F.F., Bongers, M.Y., Hooff, M.H. van, Ploeg, M., Coppus, S.F.P.J., Ankum, W.M., and Mol, B.W.

Abstract

Item does not contain fulltext, OBJECTIVE: To assess the effectiveness of curettage versus expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage. STUDY DESIGN: We conducted a multicenter cohort study alongside a randomized clinical trial (RCT) between June 2012 until July 2014. 27 Dutch hospitals participated. Women with an incomplete evacuation after misoprostol treatment for first trimester miscarriage who declined to participate in the RCT, received treatment of their preference; curettage (n=65) or expectant management (n=132). A successful outcome was defined as an empty uterus on sonography at six weeks or uneventful clinical follow-up. We furthermore assessed complication rate and (re)intervention rate RESULTS: Of the 197 women who declined to participate in the RCT, 65 preferred curettage and 132 expectant management. A successful outcome was observed in 62/65 women (95%) in the surgical group versus 112/132 women (85%) in the expectant group (RR 1.1, 95% CI 1.03-1.2), with complication rates of 6.2% versus 2.3%, respectively (RR 2.7, 95% CI 0.6-12). CONCLUSION: In women with an incomplete evacuation of the uterus after misoprostol treatment, expectant management is an effective and safe option. This finding could restrain the use of curettage in women that have used misoprostol in the treatment of first trimester miscarriage.

Published
2017

25. Labour pain with remifentanil patient-controlled analgesia versus epidural analgesia: a randomised equivalence trial

Author

Epi Methoden Team 1, JC onderzoeksprogramma Methodologie, Logtenberg, Slm, Oude Rengerink, K, Verhoeven, C J, Freeman, L M, van den Akker, Esa, Godfried, M B, van Beek, E, Borchert, Owhm, Schuitemaker, N, van Woerkens, Ecsm, Hostijn, I, Middeldorp, J M, van der Post, J A, Mol, B W, Epi Methoden Team 1, JC onderzoeksprogramma Methodologie, Logtenberg, Slm, Oude Rengerink, K, Verhoeven, C J, Freeman, L M, van den Akker, Esa, Godfried, M B, van Beek, E, Borchert, Owhm, Schuitemaker, N, van Woerkens, Ecsm, Hostijn, I, Middeldorp, J M, van der Post, J A, and Mol, B W

Published
2017

26. MisoREST : surgical versus expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for miscarriage: a randomized controlled trial

Author

Lemmers, M, Verschoor, M A C, Oude Rengerink, K, Naaktgeboren, C, Opmeer, B C, Bossuyt, P M, Huirne, J A F, Janssen, C A H, Radder, C, Klinkert, E R, Langenveld, J, Catshoek, R, Van der Voet, L, Siemens, F, Geomini, P, Van Hooff, M H, Van der Ploeg, J M, Coppus, S F P J, Ankum, W M, Mol, B W J, and MisoREST study group

Subjects
surgery, uterus, miscarriage, Journal Article, abortion, expectant management
Abstract

STUDY QUESTION: Is curettage more effective than expectant management in case of an incomplete evacuation after misoprostol treatment for first trimester miscarriage? SUMMARY ANSWER: Curettage leads to a higher chance of complete evacuation but expectant management is successful in at least 76% of women with an incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage. WHAT IS KNOWN ALREADY: In 5-50% of the women treated with misoprostol, there is a suspicion of incomplete evacuation of the uterus on sonography. Although these women generally have minor symptoms, such a finding often leads to additional curettage. STUDY DESIGN, SIZE, DURATION: From June 2012 until July 2014, we conducted a nationwide multicenter randomized controlled trial (RCT). Women who had had primary misoprostol treatment for miscarriage with sonographic evidence of incomplete evacuation of the uterus were randomly allocated to either curettage or expectant management (1:1), using a web-based application. PARTICIPANTS/MATERIALS, SETTING, METHODS: We included 59 women in 27 hospitals; 30 were allocated to curettage and 29 were allocated to expectant management. A successful outcome was defined as sonographic finding of an empty uterus 6 weeks after randomization. MAIN RESULTS AND THE ROLE OF CHANCE: Baseline characteristics of both groups were comparable. Empty uterus on sonography or uneventful clinical follow-up was seen in 29/30 women (97%) allocated to curettage compared with 22/29 women (76%) allocated to expectant management (RR 1.3, 95% CI 1.03-1.6) with complication rates of 10% versus 10%, respectively (RR 0.97, 95% CI 0.21-4.4). In the group allocated to curettage, no woman required re-curettage, while two women (6.7%) underwent hysteroscopy (for other or unknown reasons). In the women allocated to expectant management, curettage was performed in four women (13.8%) and three women (10.3%) underwent hysteroscopy. LIMITATIONS, REASONS FOR CAUTION: Due to a strong patient preference, mainly for expectant management, the targeted sample size could not be included and the trial was stopped prematurely. WIDER IMPLICATIONS OF THE FINDINGS: In women suspected of incomplete evacuation of the uterus after misoprostol, curettage is more effective than expectant management. However, expectant management is equally safe and prevents curettage for most of the women. This finding could further restrain the use of curettage in the treatment of first trimester miscarriage. STUDY FUNDING/COMPETING INTERESTS: This study was funded by ZonMw, a Dutch organization for Health Research and Development, project number 80-82310-97-12066. There were no conflicts of interests. TRIAL REGISTRATION NUMBER: Dutch Trial Register NTR3310, http://www.trialregister.nl TRIAL REGISTRATION DATE: 27 February 2012. DATE OF FIRST PATIENT'S ENROLMENT: 12 June 2012.

Published
2016

27. Comparing induction of labour with oral misoprostol or Foley catheter at term: cost-effectiveness analysis of a randomised controlled multi-centre non-inferiority trial

Author

ten Eikelder, MLG, primary, van Baaren, G-J, additional, Oude Rengerink, K, additional, Jozwiak, M, additional, de Leeuw, JW, additional, Kleiverda, G, additional, Evers, I, additional, de Boer, K, additional, Brons, J, additional, Bloemenkamp, KWM, additional, and Mol, BW, additional

Published
2017
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28. Hysteroscopic resection of a uterine caesarean scar defect (niche) in women with postmenstrual spotting: a randomised controlled trial

Author

Vervoort, AJMW, primary, van der Voet, LF, additional, Hehenkamp, WJK, additional, Thurkow, AL, additional, van Kesteren, PJM, additional, Quartero, H, additional, Kuchenbecker, W, additional, Bongers, M, additional, Geomini, P, additional, de Vleeschouwer, LHM, additional, van Hooff, MHA, additional, van Vliet, H, additional, Veersema, S, additional, Renes, WB, additional, Oude Rengerink, K, additional, Zwolsman, SE, additional, Brölmann, HAM, additional, Mol, BWJ, additional, and Huirne, JAF, additional

Published
2017
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29. Vaginal microcirculation : Non-invasive anatomical examination of the micro-vessel architecture, tortuosity and capillary density

Author

Weber, Maaike A, Milstein, Dan M J, Ince, Can, Oude Rengerink, Katrien, Roovers, Jan-Paul W R, and Oude Rengerink, K

Subjects
vaginal microcirculation, physiology, Journal Article, imaging, Observational Study, capillary density, tortuosity
Abstract

AIM: To describe the vaginal microcirculatory architecture and capillary density parameters using sidestream dark-field imaging (SDFI), and determine feasibility and reliability of this method. METHODS: In nine healthy female volunteers SDFI measurements were performed at two different time points in the luteal phase of the menstrual cycle. Non-invasive tissue micro-angioarchitecture and vaginal capillary density measurements were assessed independently by two observers. Agreement was expressed with mean differences between the measurements of both observers and the limits of agreement. Inter- and intra-observer agreement was quantified with the intra-class correlation coefficient (ICC). RESULTS: Vaginal microcirculatory assessment with the SDFI device was easy in use, painless and well accepted by the participants. Morphologically, the vaginal microcirculation revealed an array of single hairpin-shaped capillary loops distributed homogeneously across an imaged tissue segment. The intra-observer assessment of the capillary density measurements (comparing two measurement time points of one observer) showed good agreement with an ICC ranging from 0.62 to 0.85. The inter-observer assessments of the capillary density measurements (comparing assessments of two observers at one time point) revealed very good agreement, with small differences between observers and an ICC of more than 0.9. CONCLUSIONS: This is the first report on both microcirculatory architecture and quantitative microcirculatory parameters of the vagina with the use of SDFI. Micro-vessels of the vagina show a recognizable pattern in our study population of young, healthy women. SDFI gives a reproducible assessment of the vaginal microcirculation offering the researcher a wide field of applications. Neurourol. Urodynam. 34:723-729, 2015. © 2014 Wiley Periodicals, Inc.

Published
2015

31. Transvaginal prolapse repair with or without the addition of a midurethral sling in women with genital prolapse and stress urinary incontinence : a randomised trial

Author

van der Ploeg, J M, Oude Rengerink, K, van der Steen, A, van Leeuwen, J H S, Stekelenburg, J, Bongers, M Y, Weemhoff, M, Mol, B W, van der Vaart, C H, Roovers, J-P W R, and Dutch Urogynaecology Consortium

Subjects
Questionnaires, Suburethral Slings, Urinary Bladder, Overactive, Urinary Incontinence, Stress, Research Support, Non-U.S. Gov't, Middle Aged, Midurethral sling, stress urinary incontinence, Pelvic Organ Prolapse, Multicenter Study, Gynecologic Surgical Procedures, Treatment Outcome, Randomized Controlled Trial, Journal Article, Humans, Female, randomised, Aged, Netherlands
Abstract

OBJECTIVE: To compare transvaginal prolapse repair combined with midurethral sling (MUS) versus prolapse repair only. DESIGN: Multi-centre randomised trial. SETTING: Fourteen teaching hospitals in the Netherlands. POPULATION: Women with symptomatic stage two or greater pelvic organ prolapse (POP), and subjective or objective stress urinary incontinence (SUI) without prolapse reduction. METHODS: Women were randomly assigned to undergo vaginal prolapse repair with or without MUS. Analysis was according to intention to treat. MAIN OUTCOME MEASURES: The primary outcome at 12 months' follow-up was the absence of urinary incontinence (UI) assessed with the Urogenital Distress Inventory and treatment for SUI or overactive bladder. Secondary outcomes included complications. RESULTS: One hundred and thirty-four women were analysed at 12 months' follow-up (63 in MUS and 71 in control group). More women in the MUS group reported the absence of UI and SUI; respectively 62% versus 30% UI (relative risk [RR] 2.09; 95% confidence interval [CI] 1.39-3.15) and 78% versus 39% SUI (RR 1.97; 95% CI 1.44-2.71). Fewer women underwent treatment for postoperative SUI in the MUS group (10% versus 37%; RR 0.26; 95% CI 0.11-0.59). In the control group, 12 women (17%) underwent MUS after prolapse surgery versus none in the MUS group. Severe complications were more common in the MUS group, but the difference was not statistically significant (16% versus 6%; RR 2.82; 95% CI 0.93-8.54). CONCLUSIONS: Women with prolapse and co-existing SUI are less likely to have SUI after transvaginal prolapse repair with MUS compared with prolapse repair only. However, only 17% of the women undergoing POP surgery needed additional MUS. A well-informed decision balancing risks and benefits of both strategies should be tailored to individual women.

Published
2015

32. Pregnant womens' concerns when invited to a randomized trial: a qualitative case control study

Author

Oude Rengerink, Katrien, Logtenberg, Sabine, Hooft, Lotty, Bossuyt, Patrick M, Mol, Ben Willem, Oude Rengerink, K, Epidemiology and Data Science, APH - Amsterdam Public Health, 10 Public Health & Methodologie, and Obstetrics and Gynaecology

Subjects
Adult, medicine.medical_specialty, Research Subjects, Reproductive medicine, Alternative medicine, law.invention, Randomized controlled trial, law, Pregnancy, Intervention (counseling), Health care, Obstetrics and Gynaecology, medicine, Journal Article, Humans, Qualitative Research, Netherlands, Randomized Controlled Trials as Topic, Gynecology, Motivation, business.industry, Patient Selection, Obstetrics and Gynecology, Clinical trial, Family medicine, Case-Control Studies, Female, Pregnant Women, business, Inclusion (education), Qualitative research, Research Article
Abstract

Background Pregnant women were excluded from clinical trials until the 1990s, but the Food and Drug Administration nowadays allows - and even encourages - responsible inclusion of pregnant women in trials with adequate safety monitoring. Still, randomized trials in pregnant women face specific enrolment challenges. Previous studies have focused on barriers to trial participation in studies that had failed to recruit sufficient participants. Our aim was to identify barriers and motivators for participation in a range of clinical trials being conducted in the Netherlands, regardless of recruitment performance. Methods We performed a qualitative case control study in women who had been asked in 2010 to participate in one of eight clinical trials during pregnancy or shortly after giving birth. Both participants and non-participants of these clinical trials were invited for a face-to-face interview that addressed motives for participation and non-participation. We started the interview in an open fashion, asking the women for their main motive for participation or non-participation. When no new information emerged in this open part, we continued with a semi-structured interview, guided by a topic list. Transcripts of the interviews were analysed using a constant-comparative approach. Two researchers identified barriers and facilitators for participation, conjoined into main themes. Results Of 28 women invited for the interview, 21 agreed to be interviewed (12 participants and 9 non-participants). For 5 of the 12 participants, contribution to scientific research was their main motive, while 5 had participated because the intervention seemed favorable and was not available outside the trial. Key motives for non-participation (n = 9) were a negative association or a dislike of the intervention, either because it might do harm (n = 6) or for practical reasons (n = 3). Combining the open and topic list guided interviews we constructed seven main themes that influence the pregnant women’s decision to participate: external influence, research and healthcare, perception own situation, study design, intervention, information and counselling, and uncertainty. Conclusions Among seven main themes that influence pregnant women’s decision to participate, uncertainty about scientific research or the intervention was reported to be of considerable importance. Measures should be taken to habituate pregnant women more to scientific research, and further evaluation of opt-out consent deserves attention. Electronic supplementary material The online version of this article (doi:10.1186/s12884-015-0641-x) contains supplementary material, which is available to authorized users.

Published
2015
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33. MisoREST: surgical versus expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for miscarriage: a randomized controlled trial

Author

Lemmers, M., Verschoor, M.A., Oude Rengerink, K., Naaktgeboren, C., Opmeer, B.C., Bossuyt, P.M., Huirne, J.A., Janssen, C.A.H., Radder, C., Klinkert, E.R., Langenveld, J., Catshoek, R., Voet, L. Van der, Siemens, F., Geomini, P., Hooff, M.H. van, Ploeg, J.M. van der, Coppus, S.F.P.J., Ankum, W.M., Mol, B.W., Lemmers, M., Verschoor, M.A., Oude Rengerink, K., Naaktgeboren, C., Opmeer, B.C., Bossuyt, P.M., Huirne, J.A., Janssen, C.A.H., Radder, C., Klinkert, E.R., Langenveld, J., Catshoek, R., Voet, L. Van der, Siemens, F., Geomini, P., Hooff, M.H. van, Ploeg, J.M. van der, Coppus, S.F.P.J., Ankum, W.M., and Mol, B.W.

Abstract

Item does not contain fulltext, STUDY QUESTION: Is curettage more effective than expectant management in case of an incomplete evacuation after misoprostol treatment for first trimester miscarriage? SUMMARY ANSWER: Curettage leads to a higher chance of complete evacuation but expectant management is successful in at least 76% of women with an incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage. WHAT IS KNOWN ALREADY: In 5-50% of the women treated with misoprostol, there is a suspicion of incomplete evacuation of the uterus on sonography. Although these women generally have minor symptoms, such a finding often leads to additional curettage. STUDY DESIGN, SIZE, DURATION: From June 2012 until July 2014, we conducted a nationwide multicenter randomized controlled trial (RCT). Women who had had primary misoprostol treatment for miscarriage with sonographic evidence of incomplete evacuation of the uterus were randomly allocated to either curettage or expectant management (1:1), using a web-based application. PARTICIPANTS/MATERIALS, SETTING, METHODS: We included 59 women in 27 hospitals; 30 were allocated to curettage and 29 were allocated to expectant management. A successful outcome was defined as sonographic finding of an empty uterus 6 weeks after randomization. MAIN RESULTS AND THE ROLE OF CHANCE: Baseline characteristics of both groups were comparable. Empty uterus on sonography or uneventful clinical follow-up was seen in 29/30 women (97%) allocated to curettage compared with 22/29 women (76%) allocated to expectant management (RR 1.3, 95% CI 1.03-1.6) with complication rates of 10% versus 10%, respectively (RR 0.97, 95% CI 0.21-4.4). In the group allocated to curettage, no woman required re-curettage, while two women (6.7%) underwent hysteroscopy (for other or unknown reasons). In the women allocated to expectant management, curettage was performed in four women (13.8%) and three women (10.3%) underwent hysteroscopy. LIMITATIONS, REASONS FOR CAUTION: Du

Published
2016

34. Induction of labour at term with oral misoprostol versus a Foley catheter (PROBAAT-II): a multicentre randomised controlled non-inferiority trial

Author

Eikelder, M.L. Ten, Oude Rengerink, K., Jozwiak, M., Leeuw, J.W. de, Graaf, I.M. de, Pampus, M.G. van, Holswilder, M., Oudijk, M.A., Baaren, G.J. van, Pernet, P.J., Bax, C., Unnik, G.A. van, Martens, G., Porath, M., Vliet, H. van, Rijnders, R.J., Feitsma, A.H., Roumen, F.J., Loon, A.J. van, Versendaal, H., Weinans, M.J., Woiski, M.D., Beek, E. van, Hermsen, B., Mol, B.W., Bloemenkamp, K.W., Eikelder, M.L. Ten, Oude Rengerink, K., Jozwiak, M., Leeuw, J.W. de, Graaf, I.M. de, Pampus, M.G. van, Holswilder, M., Oudijk, M.A., Baaren, G.J. van, Pernet, P.J., Bax, C., Unnik, G.A. van, Martens, G., Porath, M., Vliet, H. van, Rijnders, R.J., Feitsma, A.H., Roumen, F.J., Loon, A.J. van, Versendaal, H., Weinans, M.J., Woiski, M.D., Beek, E. van, Hermsen, B., Mol, B.W., and Bloemenkamp, K.W.

Abstract

Item does not contain fulltext, BACKGROUND: Labour is induced in 20-30% of all pregnancies. In women with an unfavourable cervix, both oral misoprostol and Foley catheter are equally effective compared with dinoprostone in establishing vaginal birth, but each has a better safety profile. We did a trial to directly compare oral misoprostol with Foley catheter alone. METHODS: We did an open-label randomised non-inferiority trial in 29 hospitals in the Netherlands. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section who were scheduled for induction of labour were randomly allocated to cervical ripening with 50 mug oral misoprostol once every 4 h or to a 30 mL transcervical Foley catheter. The primary outcome was a composite of asphyxia (pH /=1000 mL). The non-inferiority margin was 5%. The trial is registered with the Netherlands Trial Register, NTR3466. FINDINGS: Between July, 2012, and October, 2013, we randomly assigned 932 women to oral misoprostol and 927 women to Foley catheter. The composite primary outcome occurred in 113 (12.2%) of 924 participants in the misoprostol group versus 106 (11.5%) of 921 in the Foley catheter group (adjusted relative risk 1.06, 90% CI 0.86-1.31). Caesarean section occurred in 155 (16.8%) women versus 185 (20.1%; relative risk 0.84, 95% CI 0.69-1.02, p=0.067). 27 adverse events were reported in the misoprostol group versus 25 in the Foley catheter group. None were directly related to the study procedure. INTERPRETATION: In women with an unfavourable cervix at term, induction of labour with oral misoprostol and Foley catheter has similar safety and effectiveness. FUNDING: FondsNutsOhra.

Published
2016

36. MisoREST: surgical versus expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for miscarriage: a randomized controlled trial

Author

Epi Methoden Team 1, JC onderzoeksprogramma Methodologie, Lemmers, M, Verschoor, M A C, Oude Rengerink, K, Naaktgeboren, C, Opmeer, B C, Bossuyt, P M, Huirne, J A F, Janssen, C A H, Radder, C, Klinkert, E R, Langenveld, J, Catshoek, R, Van der Voet, L, Siemens, F, Geomini, P, Van Hooff, M H, Van der Ploeg, J M, Coppus, S F P J, Ankum, W M, Mol, B W J, MisoREST study group, Epi Methoden Team 1, JC onderzoeksprogramma Methodologie, Lemmers, M, Verschoor, M A C, Oude Rengerink, K, Naaktgeboren, C, Opmeer, B C, Bossuyt, P M, Huirne, J A F, Janssen, C A H, Radder, C, Klinkert, E R, Langenveld, J, Catshoek, R, Van der Voet, L, Siemens, F, Geomini, P, Van Hooff, M H, Van der Ploeg, J M, Coppus, S F P J, Ankum, W M, Mol, B W J, and MisoREST study group

Published
2016

38. Embedding trials in evidence-based clinical practice

Author

Oude Rengerink, K., Bossuyt, P.M.M., Mol, B.W.J., Hooft, L., and Faculteit der Geneeskunde

Subjects
education
Abstract

This thesis presents a number of research projects centred on ‘evidence-based medicine’. It consists of two parts. Part 1 focuses on improving recruitment of the necessary number of patients in clinical trials, as this is the major problem while evaluating the effectiveness of interventions in health care. To improve our understanding of patient recruitment we tried to identify obstacles and facilitators for successful recruitment. Part 2 focuses on improving integration of evidence-based decision making in clinical practice. We identified barriers for EBM teaching in practice, developed an EBM Teach the Teacher course, and evaluated methods to assess EBM in clinical practice.

Published
2014

39. Making Pragmatic Trials Work

Author

Zuidgeest, MG, primary, Stolk, P, additional, Oude Rengerink, K, additional, Goetz, IA, additional, Welsing, PM, additional, and Grobbee, DE, additional

Published
2016
Full Text
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40. MisoREST: surgical versus expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for miscarriage: a randomized controlled trial

Author

Lemmers, M., primary, Verschoor, M.A.C., additional, Oude Rengerink, K., additional, Naaktgeboren, C., additional, Opmeer, B.C., additional, Bossuyt, P.M., additional, Huirne, J.A.F., additional, Janssen, C.A.H., additional, Radder, C., additional, Klinkert, E.R., additional, Langenveld, J., additional, Catshoek, R., additional, Van der Voet, L., additional, Siemens, F., additional, Geomini, P., additional, Van Hooff, M.H., additional, Van der Ploeg, J.M., additional, Coppus, S.F.P.J., additional, Ankum, W.M., additional, and Mol, B.W.J., additional

Published
2016
Full Text
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41. Labour pain with remifentanil patient-controlled analgesia versus epidural analgesia: a randomised equivalence trial

Author

Logtenberg, SLM, primary, Oude Rengerink, K, additional, Verhoeven, CJ, additional, Freeman, LM, additional, van den Akker, ESA, additional, Godfried, MB, additional, van Beek, E, additional, Borchert, OWHM, additional, Schuitemaker, N, additional, van Woerkens, ECSM, additional, Hostijn, I, additional, Middeldorp, JM, additional, van der Post, JA, additional, and Mol, BW, additional

Published
2016
Full Text
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42. Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial

Author

Freeman, L.M., Bloemenkamp, K.W., Franssen, M.T., Papatsonis, D.N., Hajenius, P.J., Hollmann, M.W., Woiski, M.D., Porath, M., Berg, H.J. van den, Beek, E. van, Borchert, O.W., Schuitemaker, N., Sikkema, J.M., Kuipers, A.H., Logtenberg, S.L., Salm, P.C. van der, Oude Rengerink, K., Lopriore, E., Akker-van Marle, M.E. van den, Cessie, S. le, Lith, J.M. van, Struys, M.M., Mol, B.W., Dahan, A, Middeldorp, J.M., Freeman, L.M., Bloemenkamp, K.W., Franssen, M.T., Papatsonis, D.N., Hajenius, P.J., Hollmann, M.W., Woiski, M.D., Porath, M., Berg, H.J. van den, Beek, E. van, Borchert, O.W., Schuitemaker, N., Sikkema, J.M., Kuipers, A.H., Logtenberg, S.L., Salm, P.C. van der, Oude Rengerink, K., Lopriore, E., Akker-van Marle, M.E. van den, Cessie, S. le, Lith, J.M. van, Struys, M.M., Mol, B.W., Dahan, A, and Middeldorp, J.M.

Abstract

Contains fulltext : 153600.pdf (Publisher’s version ) (Open Access), OBJECTIVE: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN: Multicentre randomised controlled equivalence trial. SETTING: 15 hospitals in the Netherlands. PARTICIPANTS: Women with an intermediate to high obstetric risk with an intention to deliver vaginally. To exclude a clinically relevant difference in satisfaction with pain relief of more than 10%, we needed to include 1136 women. Because of missing values for satisfaction this number was increased to 1400 before any analysis. We used multiple imputation to correct for missing data. INTERVENTION: Before the onset of active labour consenting women were randomised to a pain relief strategy with patient controlled remifentanil or epidural analgesia if they requested pain relief during labour. MAIN OUTCOME MEASURES: Primary outcome was satisfaction with pain relief, measured hourly on a visual analogue scale and expressed as area under the curve (AUC), thus providing a time weighted measure of total satisfaction with pain relief. A higher AUC represents higher satisfaction with pain relief. Secondary outcomes were pain intensity scores, mode of delivery, and maternal and neonatal outcomes. Analysis was done by intention to treat. The study was defined as an equivalence study for the primary outcome. RESULTS: 1414 women were randomised, of whom 709 were allocated to patient controlled remifentanil and 705 to epidural analgesia. Baseline characteristics were comparable. Pain relief was ultimately used in 65% (447/687) in the remifentanil group and 52% (347/671) in the epidural analgesia group (relative risk 1.32, 95% confidence interval 1.18 to 1.48). Cross over occurred in 7% (45/687) and 8% (51/671) of women, respectively. Of women primarily treated with remifentanil, 13% (53/402) converted to epidural analgesia, while in women primarily treated with epidural analgesia 1% (3/296) converted to remifentanil. T

Published
2015

43. Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

Author

Freeman, Liv M, Bloemenkamp, Kitty W, Franssen, Maureen T, Papatsonis, Dimitri N, Hajenius, Petra J, Hollmann, Markus W, Woiski, Mallory D, Porath, Martina, van den Berg, Hans J, van Beek, Erik, Borchert, Odette W H M, Schuitemaker, Nico, Sikkema, J Marko, Kuipers, A H M, Logtenberg, Sabine L M, van der Salm, Paulien C M, Oude Rengerink, Katrien, Lopriore, Enrico, van den Akker-van Marle, M Elske, le Cessie, Saskia, van Lith, Jan M, Struys, Michel M, Mol, Ben Willem J, Dahan, Albert, Middeldorp, Johanna M, Oude Rengerink, K, Freeman, Liv M, Bloemenkamp, Kitty W, Franssen, Maureen T, Papatsonis, Dimitri N, Hajenius, Petra J, Hollmann, Markus W, Woiski, Mallory D, Porath, Martina, van den Berg, Hans J, van Beek, Erik, Borchert, Odette W H M, Schuitemaker, Nico, Sikkema, J Marko, Kuipers, A H M, Logtenberg, Sabine L M, van der Salm, Paulien C M, Oude Rengerink, Katrien, Lopriore, Enrico, van den Akker-van Marle, M Elske, le Cessie, Saskia, van Lith, Jan M, Struys, Michel M, Mol, Ben Willem J, Dahan, Albert, Middeldorp, Johanna M, and Oude Rengerink, K

Published
2015

44. The HysNiche trial : hysteroscopic resection of uterine caesarean scar defect (niche) in patients with abnormal bleeding, a randomised controlled trial

Author

Vervoort, A J M W, Van der Voet, L F, Witmer, M, Thurkow, A L, Radder, C M, van Kesteren, P J M, Quartero, H W P, Kuchenbecker, W K H, Bongers, M Y, Geomini, P M A J, de Vleeschouwer, L H M, van Hooff, M H A, van Vliet, H A A M, Veersema, S, Renes, W B, van Meurs, H S, Bosmans, J, Oude Rengerink, K, Brölmann, H A M, Mol, B W J, Huirne, J A F, Vervoort, A J M W, Van der Voet, L F, Witmer, M, Thurkow, A L, Radder, C M, van Kesteren, P J M, Quartero, H W P, Kuchenbecker, W K H, Bongers, M Y, Geomini, P M A J, de Vleeschouwer, L H M, van Hooff, M H A, van Vliet, H A A M, Veersema, S, Renes, W B, van Meurs, H S, Bosmans, J, Oude Rengerink, K, Brölmann, H A M, Mol, B W J, and Huirne, J A F

Published
2015

46. Pregnant womens' concerns when invited to a randomized trial: a qualitative case control study

Author

Epi Methoden Team 1, Epi Methoden Team 5, Other research (not in main researchprogram), JC onderzoeksprogramma Methodologie, Oude Rengerink, Katrien, Logtenberg, Sabine, Hooft, Lotty, Bossuyt, Patrick M, Mol, Ben Willem, Oude Rengerink, K, Epi Methoden Team 1, Epi Methoden Team 5, Other research (not in main researchprogram), JC onderzoeksprogramma Methodologie, Oude Rengerink, Katrien, Logtenberg, Sabine, Hooft, Lotty, Bossuyt, Patrick M, Mol, Ben Willem, and Oude Rengerink, K

Published
2015

47. Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial

Author

MMB Research line 1, Epi Methoden Team 1, Freeman, Liv M, Bloemenkamp, Kitty W, Franssen, Maureen T, Papatsonis, Dimitri N, Hajenius, Petra J, Hollmann, Markus W, Woiski, Mallory D, Porath, Martina, van den Berg, Hans J, van Beek, Erik, Borchert, Odette W H M, Schuitemaker, Nico, Sikkema, J Marko, Kuipers, A H M, Logtenberg, Sabine L M, van der Salm, Paulien C M, Oude Rengerink, Katrien, Lopriore, Enrico, van den Akker-van Marle, M Elske, le Cessie, Saskia, van Lith, Jan M, Struys, Michel M, Mol, Ben Willem J, Dahan, Albert, Middeldorp, Johanna M, Oude Rengerink, K, MMB Research line 1, Epi Methoden Team 1, Freeman, Liv M, Bloemenkamp, Kitty W, Franssen, Maureen T, Papatsonis, Dimitri N, Hajenius, Petra J, Hollmann, Markus W, Woiski, Mallory D, Porath, Martina, van den Berg, Hans J, van Beek, Erik, Borchert, Odette W H M, Schuitemaker, Nico, Sikkema, J Marko, Kuipers, A H M, Logtenberg, Sabine L M, van der Salm, Paulien C M, Oude Rengerink, Katrien, Lopriore, Enrico, van den Akker-van Marle, M Elske, le Cessie, Saskia, van Lith, Jan M, Struys, Michel M, Mol, Ben Willem J, Dahan, Albert, Middeldorp, Johanna M, and Oude Rengerink, K

Published
2015

50. Transvaginal prolapse repair with or without the addition of a midurethral sling in women with genital prolapse and stress urinary incontinence: a randomised trial

Author

Epi Methoden Team 1, Arts-assistenten DV&B, Arts-assistenten Kinderen, MS VPG/Gynaecologie, Other research (not in main researchprogram), van der Ploeg, J M, Oude Rengerink, K, van der Steen, A, van Leeuwen, J H S, Stekelenburg, J, Bongers, M Y, Weemhoff, M, Mol, B W, van der Vaart, C H, Roovers, J-P W R, Dutch Urogynaecology Consortium, Epi Methoden Team 1, Arts-assistenten DV&B, Arts-assistenten Kinderen, MS VPG/Gynaecologie, Other research (not in main researchprogram), van der Ploeg, J M, Oude Rengerink, K, van der Steen, A, van Leeuwen, J H S, Stekelenburg, J, Bongers, M Y, Weemhoff, M, Mol, B W, van der Vaart, C H, Roovers, J-P W R, and Dutch Urogynaecology Consortium

Published
2015

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