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5. External validation of prognostic models to predict stillbirth using International Prediction of Pregnancy Complications (IPPIC) Network database: individual participant data meta-analysis

Author

Allotey, J, Whittle, R, Snell, K, Smuk, M, Townsend, R, von Dadelszen, P, Heazell, A, Magee, L, Smith, G, Sandall, J, Thilaganathan, B, Zamora, J, Riley, R, Khalil, A, Thangaratinam, S, Coomarasamy, A, Kwong, A, Savitri, A, Salvesen, K, Bhattacharya, S, Uiterwaal, C, Staff, A, Andersen, L, Olive, E, Redman, C, Sletner, L, Daskalakis, G, Macleod, M, Abdollahain, M, Ramirez, J, Masse, J, Audibert, F, Magnus, P, Jenum, A, Baschat, A, Ohkuchi, A, Mcauliffe, F, West, J, Askie, L, Mone, F, Farrar, D, Zimmerman, P, Smits, L, Riddell, C, Kingdom, J, van de Post, J, Illanes, S, Holzman, C, van Kuijk, S, Carbillon, L, Villa, P, Eskild, A, Chappell, L, Prefumo, F, Velauthar, L, Seed, P, van Oostwaard, M, Verlohren, S, Poston, L, Ferrazzi, E, Vinter, C, Nagata, C, Brown, M, Vollebregt, K, Takeda, S, Langenveld, J, Widmer, M, Saito, S, Haavaldsen, C, Carroli, G, Olsen, J, Wolf, H, Zavaleta, N, Eisensee, I, Vergani, P, Lumbiganon, P, Makrides, M, Facchinetti, F, Sequeira, E, Gibson, R, Ferrazzani, S, Frusca, T, Norman, J, Figueiro, E, Lapaire, O, Laivuori, H, Lykke, J, Conde-Agudelo, A, Galindo, A, Mbah, A, Betran, A, Herraiz, I, Trogstad, L, Steegers, E, Salim, R, Huang, T, Adank, A, Zhang, J, Meschino, W, Browne, J, Allen, R, Costa, F, Klipstein-Grobusch Browne, K, Crowther, C, Jorgensen, J, Forest, J, Rumbold, A, Mol, B, Giguere, Y, Kenny, L, Ganzevoort, W, Odibo, A, Myers, J, Yeo, S, Goffinet, F, Mccowan, L, Pajkrt, E, Teede, H, Haddad, B, Dekker, G, Kleinrouweler, E, Lecarpentier, E, Roberts, C, Groen, H, Skrastad, R, Heinonen, S, Eero, K, Anggraini, D, Souka, A, Cecatti, J, Monterio, I, Pillalis, A, Souza, R, Hawkins, L, Gabbay-Benziv, R, Crovetto, F, Figuera, F, Jorgensen, L, Dodds, J, Patel, M, Aviram, A, Papageorghiou, A, Khan, K, Allotey J., Whittle R., Snell K. I. E., Smuk M., Townsend R., von Dadelszen P., Heazell A. E. P., Magee L., Smith G. C. S., Sandall J., Thilaganathan B., Zamora J., Riley R. D., Khalil A., Thangaratinam S., Coomarasamy A., Kwong A., Savitri A. I., Salvesen K. A., Bhattacharya S., Uiterwaal C. S. P. M., Staff A. C., Andersen L. B., Olive E. L., Redman C., Sletner L., Daskalakis G., Macleod M., Abdollahain M., Ramirez J. A., Masse J., Audibert F., Magnus P. M., Jenum A. K., Baschat A., Ohkuchi A., McAuliffe F. M., West J., Askie L. M., Mone F., Farrar D., Zimmerman P. A., Smits L. J. M., Riddell C., Kingdom J. C., van de Post J., Illanes S. E., Holzman C., van Kuijk S. M. J., Carbillon L., Villa P. M., Eskild A., Chappell L., Prefumo F., Velauthar L., Seed P., van Oostwaard M., Verlohren S., Poston L., Ferrazzi E., Vinter C. A., Nagata C., Brown M., Vollebregt K. C., Takeda S., Langenveld J., Widmer M., Saito S., Haavaldsen C., Carroli G., Olsen J., Wolf H., Zavaleta N., Eisensee I., Vergani P., Lumbiganon P., Makrides M., Facchinetti F., Sequeira E., Gibson R., Ferrazzani S., Frusca T., Norman J. E., Figueiro E. A., Lapaire O., Laivuori H., Lykke J. A., Conde-Agudelo A., Galindo A., Mbah A., Betran A. P., Herraiz I., Trogstad L., Smith G. G. S., Steegers E. A. P., Salim R., Huang T., Adank A., Zhang J., Meschino W. S., Browne J. L., Allen R. E., Costa F. D. S., Klipstein-Grobusch Browne K., Crowther C. A., Jorgensen J. S., Forest J. -C., Rumbold A. R., Mol B. W., Giguere Y., Kenny L. C., Ganzevoort W., Odibo A. O., Myers J., Yeo S. A., Goffinet F., McCowan L., Pajkrt E., Teede H. J., Haddad B. G., Dekker G., Kleinrouweler E. C., LeCarpentier E., Roberts C. T., Groen H., Skrastad R. B., Heinonen S., Eero K., Anggraini D., Souka A., Cecatti J. G., Monterio I., Pillalis A., Souza R., Hawkins L. A., Gabbay-Benziv R., Crovetto F., Figuera F., Jorgensen L., Dodds J., Patel M., Aviram A., Papageorghiou A., Khan K., Allotey, J, Whittle, R, Snell, K, Smuk, M, Townsend, R, von Dadelszen, P, Heazell, A, Magee, L, Smith, G, Sandall, J, Thilaganathan, B, Zamora, J, Riley, R, Khalil, A, Thangaratinam, S, Coomarasamy, A, Kwong, A, Savitri, A, Salvesen, K, Bhattacharya, S, Uiterwaal, C, Staff, A, Andersen, L, Olive, E, Redman, C, Sletner, L, Daskalakis, G, Macleod, M, Abdollahain, M, Ramirez, J, Masse, J, Audibert, F, Magnus, P, Jenum, A, Baschat, A, Ohkuchi, A, Mcauliffe, F, West, J, Askie, L, Mone, F, Farrar, D, Zimmerman, P, Smits, L, Riddell, C, Kingdom, J, van de Post, J, Illanes, S, Holzman, C, van Kuijk, S, Carbillon, L, Villa, P, Eskild, A, Chappell, L, Prefumo, F, Velauthar, L, Seed, P, van Oostwaard, M, Verlohren, S, Poston, L, Ferrazzi, E, Vinter, C, Nagata, C, Brown, M, Vollebregt, K, Takeda, S, Langenveld, J, Widmer, M, Saito, S, Haavaldsen, C, Carroli, G, Olsen, J, Wolf, H, Zavaleta, N, Eisensee, I, Vergani, P, Lumbiganon, P, Makrides, M, Facchinetti, F, Sequeira, E, Gibson, R, Ferrazzani, S, Frusca, T, Norman, J, Figueiro, E, Lapaire, O, Laivuori, H, Lykke, J, Conde-Agudelo, A, Galindo, A, Mbah, A, Betran, A, Herraiz, I, Trogstad, L, Steegers, E, Salim, R, Huang, T, Adank, A, Zhang, J, Meschino, W, Browne, J, Allen, R, Costa, F, Klipstein-Grobusch Browne, K, Crowther, C, Jorgensen, J, Forest, J, Rumbold, A, Mol, B, Giguere, Y, Kenny, L, Ganzevoort, W, Odibo, A, Myers, J, Yeo, S, Goffinet, F, Mccowan, L, Pajkrt, E, Teede, H, Haddad, B, Dekker, G, Kleinrouweler, E, Lecarpentier, E, Roberts, C, Groen, H, Skrastad, R, Heinonen, S, Eero, K, Anggraini, D, Souka, A, Cecatti, J, Monterio, I, Pillalis, A, Souza, R, Hawkins, L, Gabbay-Benziv, R, Crovetto, F, Figuera, F, Jorgensen, L, Dodds, J, Patel, M, Aviram, A, Papageorghiou, A, Khan, K, Allotey J., Whittle R., Snell K. I. E., Smuk M., Townsend R., von Dadelszen P., Heazell A. E. P., Magee L., Smith G. C. S., Sandall J., Thilaganathan B., Zamora J., Riley R. D., Khalil A., Thangaratinam S., Coomarasamy A., Kwong A., Savitri A. I., Salvesen K. A., Bhattacharya S., Uiterwaal C. S. P. M., Staff A. C., Andersen L. B., Olive E. L., Redman C., Sletner L., Daskalakis G., Macleod M., Abdollahain M., Ramirez J. A., Masse J., Audibert F., Magnus P. M., Jenum A. K., Baschat A., Ohkuchi A., McAuliffe F. M., West J., Askie L. M., Mone F., Farrar D., Zimmerman P. A., Smits L. J. M., Riddell C., Kingdom J. C., van de Post J., Illanes S. E., Holzman C., van Kuijk S. M. J., Carbillon L., Villa P. M., Eskild A., Chappell L., Prefumo F., Velauthar L., Seed P., van Oostwaard M., Verlohren S., Poston L., Ferrazzi E., Vinter C. A., Nagata C., Brown M., Vollebregt K. C., Takeda S., Langenveld J., Widmer M., Saito S., Haavaldsen C., Carroli G., Olsen J., Wolf H., Zavaleta N., Eisensee I., Vergani P., Lumbiganon P., Makrides M., Facchinetti F., Sequeira E., Gibson R., Ferrazzani S., Frusca T., Norman J. E., Figueiro E. A., Lapaire O., Laivuori H., Lykke J. A., Conde-Agudelo A., Galindo A., Mbah A., Betran A. P., Herraiz I., Trogstad L., Smith G. G. S., Steegers E. A. P., Salim R., Huang T., Adank A., Zhang J., Meschino W. S., Browne J. L., Allen R. E., Costa F. D. S., Klipstein-Grobusch Browne K., Crowther C. A., Jorgensen J. S., Forest J. -C., Rumbold A. R., Mol B. W., Giguere Y., Kenny L. C., Ganzevoort W., Odibo A. O., Myers J., Yeo S. A., Goffinet F., McCowan L., Pajkrt E., Teede H. J., Haddad B. G., Dekker G., Kleinrouweler E. C., LeCarpentier E., Roberts C. T., Groen H., Skrastad R. B., Heinonen S., Eero K., Anggraini D., Souka A., Cecatti J. G., Monterio I., Pillalis A., Souza R., Hawkins L. A., Gabbay-Benziv R., Crovetto F., Figuera F., Jorgensen L., Dodds J., Patel M., Aviram A., Papageorghiou A., and Khan K.

Abstract

Objective: Stillbirth is a potentially preventable complication of pregnancy. Identifying women at high risk of stillbirth can guide decisions on the need for closer surveillance and timing of delivery in order to prevent fetal death. Prognostic models have been developed to predict the risk of stillbirth, but none has yet been validated externally. In this study, we externally validated published prediction models for stillbirth using individual participant data (IPD) meta-analysis to assess their predictive performance. Methods: MEDLINE, EMBASE, DH-DATA and AMED databases were searched from inception to December 2020 to identify studies reporting stillbirth prediction models. Studies that developed or updated prediction models for stillbirth for use at any time during pregnancy were included. IPD from cohorts within the International Prediction of Pregnancy Complications (IPPIC) Network were used to validate externally the identified prediction models whose individual variables were available in the IPD. The risk of bias of the models and cohorts was assessed using the Prediction study Risk Of Bias ASsessment Tool (PROBAST). The discriminative performance of the models was evaluated using the C-statistic, and calibration was assessed using calibration plots, calibration slope and calibration-in-the-large. Performance measures were estimated separately in each cohort, as well as summarized across cohorts using random-effects meta-analysis. Clinical utility was assessed using net benefit. Results: Seventeen studies reporting the development of 40 prognostic models for stillbirth were identified. None of the models had been previously validated externally, and the full model equation was reported for only one-fifth (20%, 8/40) of the models. External validation was possible for three of these models, using IPD from 19 cohorts (491 201 pregnant women) within the IPPIC Network database. Based on evaluation of the model development studies, all three models had an overa

Published
2022

6. External validation of prognostic models to predict stillbirth using International Prediction of Pregnancy Complications (IPPIC) Network database: individual participant data meta-analysis

Author

Allotey, J., Whittle, R., Snell, K. I. E., Smuk, M., Townsend, R., von Dadelszen, P., Heazell, A. E. P., Magee, L., Smith, G. C. S., Sandall, J., Thilaganathan, B., Zamora, J., Riley, R. D., Khalil, A., Thangaratinam, S., Coomarasamy, A., Kwong, A., Savitri, A. I., Salvesen, K. A., Bhattacharya, S., Uiterwaal, C. S. P. M., Staff, A. C., Andersen, L. B., Olive, E. L., Redman, C., Sletner, L., Daskalakis, G., Macleod, M., Abdollahain, M., Ramirez, J. A., Masse, J., Audibert, F., Magnus, P. M., Jenum, A. K., Baschat, A., Ohkuchi, A., Mcauliffe, F. M., West, J., Askie, L. M., Mone, F., Farrar, D., Zimmerman, P. A., Smits, L. J. M., Riddell, C., Kingdom, J. C., van de Post, J., Illanes, S. E., Holzman, C., van Kuijk, S. M. J., Carbillon, L., Villa, P. M., Eskild, A., Chappell, L., Prefumo, F., Velauthar, L., Seed, P., van Oostwaard, M., Verlohren, S., Poston, L., Ferrazzi, E., Vinter, C. A., Nagata, C., Brown, M., Vollebregt, K. C., Takeda, S., Langenveld, J., Widmer, M., Saito, S., Haavaldsen, C., Carroli, G., Olsen, J., Wolf, H., Zavaleta, N., Eisensee, I., Vergani, P., Lumbiganon, P., Makrides, M., Facchinetti, F., Sequeira, E., Gibson, R., Ferrazzani, S., Frusca, T., Norman, J. E., Figueiro, E. A., Lapaire, O., Laivuori, H., Lykke, J. A., Conde-Agudelo, A., Galindo, A., Mbah, A., Betran, A. P., Herraiz, I., Trogstad, L., Smith, G. G. S., Steegers, E. A. P., Salim, R., Huang, T., Adank, A., Zhang, J., Meschino, W. S., Browne, J. L., Allen, R. E., Costa, F. D. S., Klipstein-Grobusch Browne, K., Crowther, C. A., Jorgensen, J. S., Forest, J. -C., Rumbold, A. R., Mol, B. W., Giguere, Y., Kenny, L. C., Ganzevoort, W., Odibo, A. O., Myers, J., Yeo, S. A., Goffinet, F., Mccowan, L., Pajkrt, E., Teede, H. J., Haddad, B. G., Dekker, G., Kleinrouweler, E. C., Lecarpentier, E., Roberts, C. T., Groen, H., Skrastad, R. B., Heinonen, S., Eero, K., Anggraini, D., Souka, A., Cecatti, J. G., Monterio, I., Pillalis, A., Souza, R., Hawkins, L. A., Gabbay-Benziv, R., Crovetto, F., Figuera, F., Jorgensen, L., Dodds, J., Patel, M., Aviram, A., Papageorghiou, A., Khan, K., Clinicum, HUS Gynecology and Obstetrics, Department of Obstetrics and Gynecology, HUS Children and Adolescents, Lastentautien yksikkö, Children's Hospital, Allotey, J, Whittle, R, Snell, K, Smuk, M, Townsend, R, von Dadelszen, P, Heazell, A, Magee, L, Smith, G, Sandall, J, Thilaganathan, B, Zamora, J, Riley, R, Khalil, A, Thangaratinam, S, Coomarasamy, A, Kwong, A, Savitri, A, Salvesen, K, Bhattacharya, S, Uiterwaal, C, Staff, A, Andersen, L, Olive, E, Redman, C, Sletner, L, Daskalakis, G, Macleod, M, Abdollahain, M, Ramirez, J, Masse, J, Audibert, F, Magnus, P, Jenum, A, Baschat, A, Ohkuchi, A, Mcauliffe, F, West, J, Askie, L, Mone, F, Farrar, D, Zimmerman, P, Smits, L, Riddell, C, Kingdom, J, van de Post, J, Illanes, S, Holzman, C, van Kuijk, S, Carbillon, L, Villa, P, Eskild, A, Chappell, L, Prefumo, F, Velauthar, L, Seed, P, van Oostwaard, M, Verlohren, S, Poston, L, Ferrazzi, E, Vinter, C, Nagata, C, Brown, M, Vollebregt, K, Takeda, S, Langenveld, J, Widmer, M, Saito, S, Haavaldsen, C, Carroli, G, Olsen, J, Wolf, H, Zavaleta, N, Eisensee, I, Vergani, P, Lumbiganon, P, Makrides, M, Facchinetti, F, Sequeira, E, Gibson, R, Ferrazzani, S, Frusca, T, Norman, J, Figueiro, E, Lapaire, O, Laivuori, H, Lykke, J, Conde-Agudelo, A, Galindo, A, Mbah, A, Betran, A, Herraiz, I, Trogstad, L, Steegers, E, Salim, R, Huang, T, Adank, A, Zhang, J, Meschino, W, Browne, J, Allen, R, Costa, F, Klipstein-Grobusch Browne, K, Crowther, C, Jorgensen, J, Forest, J, Rumbold, A, Mol, B, Giguere, Y, Kenny, L, Ganzevoort, W, Odibo, A, Myers, J, Yeo, S, Goffinet, F, Mccowan, L, Pajkrt, E, Teede, H, Haddad, B, Dekker, G, Kleinrouweler, E, Lecarpentier, E, Roberts, C, Groen, H, Skrastad, R, Heinonen, S, Eero, K, Anggraini, D, Souka, A, Cecatti, J, Monterio, I, Pillalis, A, Souza, R, Hawkins, L, Gabbay-Benziv, R, Crovetto, F, Figuera, F, Jorgensen, L, Dodds, J, Patel, M, Aviram, A, Papageorghiou, A, Khan, K, Tampere University, Obstetrics and Gynaecology, APH - Quality of Care, Amsterdam Reproduction & Development (AR&D), APH - Personalized Medicine, APH - Digital Health, and Obstetrics and gynaecology

Subjects
Calibration (statistics), Perinatal Death, Overfitting, Cohort Studies, Fetal Development, 0302 clinical medicine, Discriminative model, 3123 Gynaecology and paediatrics, Models, Pregnancy, GROWTH RESTRICTION, Statistics, Medicine, Prenatal, 030212 general & internal medicine, Ultrasonography, RISK, 030219 obstetrics & reproductive medicine, PRETERM, Radiological and Ultrasound Technology, LOW-DOSE ASPIRIN, DIAGNOSIS TRIPOD, Obstetrics and Gynecology, General Medicine, Statistical, Stillbirth, Prognosis, Pregnancy Complication, external validation, individual participant data, intrauterine death, prediction model, stillbirth, Female, Humans, Infant, Newborn, Models, Statistical, Pregnancy Complications, Regression Analysis, Risk Assessment, Ultrasonography, Prenatal, 3. Good health, PREECLAMPSIA, Meta-analysis, Human, Cohort study, Prognosi, MEDLINE, Regression Analysi, WEEKS GESTATION, 03 medical and health sciences, VELOCIMETRY, Radiology, Nuclear Medicine and imaging, RECURRENCE, business.industry, Infant, Newborn, R1, HYPERTENSIVE DISORDERS, Reproductive Medicine, Sample size determination, Cohort Studie, RG, business, RA, Predictive modelling
Abstract

Objective Stillbirth is a potentially preventable complication of pregnancy. Identifying women at high risk of stillbirth can guide decisions on the need for closer surveillance and timing of delivery in order to prevent fetal death. Prognostic models have been developed to predict the risk of stillbirth, but none has yet been validated externally. In this study, we externally validated published prediction models for stillbirth using individual participant data (IPD) meta-analysis to assess their predictive performance. Methods MEDLINE, EMBASE, DH-DATA and AMED databases were searched from inception to December 2020 to identify studies reporting stillbirth prediction models. Studies that developed or updated prediction models for stillbirth for use at any time during pregnancy were included. IPD from cohorts within the International Prediction of Pregnancy Complications (IPPIC) Network were used to validate externally the identified prediction models whose individual variables were available in the IPD. The risk of bias of the models and cohorts was assessed using the Prediction study Risk Of Bias ASsessment Tool (PROBAST). The discriminative performance of the models was evaluated using the C-statistic, and calibration was assessed using calibration plots, calibration slope and calibration-in-the-large. Performance measures were estimated separately in each cohort, as well as summarized across cohorts using random-effects meta-analysis. Clinical utility was assessed using net benefit. Results Seventeen studies reporting the development of 40 prognostic models for stillbirth were identified. None of the models had been previously validated externally, and the full model equation was reported for only one-fifth (20%, 8/40) of the models. External validation was possible for three of these models, using IPD from 19 cohorts (491 201 pregnant women) within the IPPIC Network database. Based on evaluation of the model development studies, all three models had an overall high risk of bias, according to PROBAST. In the IPD meta-analysis, the models had summary C-statistics ranging from 0.53 to 0.65 and summary calibration slopes ranging from 0.40 to 0.88, with risk predictions that were generally too extreme compared with the observed risks. The models had little to no clinical utility, as assessed by net benefit. However, there remained uncertainty in the performance of some models due to small available sample sizes. Conclusions The three validated stillbirth prediction models showed generally poor and uncertain predictive performance in new data, with limited evidence to support their clinical application. The findings suggest methodological shortcomings in their development, including overfitting. Further research is needed to further validate these and other models, identify stronger prognostic factors and develop more robust prediction models. (c) 2021 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Published
2022
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7. Standardising definitions for the pre-eclampsia core outcome set: A consensus development study

Author

Duffy, J. M. N., Cairns, A. E., Magee, L. A., von Dadelszen, P., van 't Hooft, J., Gale, C., Brown, M., Chappell, L. C., Grobman, W. A., Fitzpatrick, R., Karumanchi, S. A., Lucas, D. N., Mol, B., Stark, M., Thangaratinam, S., Wilson, M. J., Williamson, P. R., Ziebland, S., Mcmanus, R. J., Abalos, E. J., Adamson, C. C. D., Akadri, A. A., Akturk, Z., Allegaert, K., Angel-Muller, E., Antretter, J., Ashdown, H. F., Audibert, F., Auger, N., Aygun, C., Babic, I., Bagga, R., Baker, J. M., Beebeejaun, Y., Bhakta, P., Bhandari, V., Bhattacharya, S., Blanker, M. H., Bloomfield, F. H., Bof, A., Brennan, S. M., Broekhuijsen, K., Broughton Pipkin, F., Browne, J. L., Browning, R. M., Bull, J. W., Butt, A., Button, D., Campbell, J. P., Campbell, D. M., Carbillon, L., Carthy, S., Casely, E., Cave, J. A., Cecatti, J. G., Chamillard, M. E., Chassard, D., Checheir, N. C., Chulkov, V. S., Cluver, C. A., Crawford, C. F., Daly, M. C., Darmochwal-Kolarz, D. A., Davies, R. E., Davies, M. W., Dawson, J. S., Dobson, N., Dodd, C. N., Donald, F., Duley, L., Epstein-Mares, J., Erez, O., Evans, E., Farlie, R. N., Ferris, A. V., Frankland, E. M., Freeman, D. J., Gainder, S., Ganzevoort, W., Gbinigie, O. A., Gerval, M. -O., Ghosh, S. K., Gingel, L. J., Glogowska, M., Goodlife, A., Gough, K. L., Green, J. R., Gul, F., Haggerty, L., Hall, D. R., Hallman, M., Hamilton, L. M., Hammond, S. J., Harlow, S. D., Hays, K. E., Hickey, S. C., Higgins, M., Hinton, L., Hobson, S. R., Hogg, M. J., Hollands, H. J., Homer, C. S. E., Hoodbhoy, Z., Howell, P., Huppertz, B., Husain, S., Jacoby, S. D., Jacqz-Aigrain, E., Jenkins, G., Jewel, D., Johnson, M. J., Johnston, C. L., Jones, P. M., Kantrowitz-Gordon, I., Khan, R. -U., Kirby, L. J., Kirk, C., Knight, M., Korey, M. T., Lee, G. J., Lee, V. W., Levene, L. S., Londero, A. P., Lust, K. M., Mackenzie, V., Malha, L., Mattone, M., Mccartney, D. E., Mcfadden, A., Mckinstry, B. H., Middleton, P. F., Mills, D. J., Mistry, H. D., Mitchell, C. A., Mockler, J. C., Molsher, S. -A., Monast, E. S., Moodley, J., Mooij, R., Moore, E. L., Morgan, L., Moulson, A., Mughal, F., Mundle, S. R., Munoz, M. A., Murray, E., Nagata, C., Nair, A. S., Nakimuli, A., Nath, G., Newport, R. S., Oakeshott, P., Ochoa-Ferraro, M. R., Odendaal, H., Ohkuchi, A., Oliveira, L., Ortiz-Panozo, E., Oudijk, M. A., Oygucu, S. E., Paech, M. J., Painter, R. C., Parry, C. L., Payne, B. A., Pearson, E. L., Phupong, V., Pickett, N., Pickles, K. A., Plumb, L. K., Prefumo, F., Preston, R., Ray, J. G., Rayment, J., Regan, L. V., Rey, E., Robson, E. J., Rubin, A. N., Rubio-Romero, J. A., Rull, K., Sass, N., Sauve, N., Savory, N. A., Scott, J. R., Seaton, S. E., Seed, P. T., Shakespeare, J. M., Shand, A. W., Sharma, S., Shaw, T. Y., Smedley, K. L., Smith, D., Smith Conk, A., Soward, D., Stepan, H., Stroumpoulis, K., Surendran, A., Takeda, S., Tan, L., Theriot, B. S., Thomas, H. F., Thompson, K., Thompson, P. I., Thompson, M. J., Toms, L., Torney, K. L. H. T., Treadwell, J. S., Tucker, K. L., Turrentine, M. A., Van Hecke, O., Van Oostwaard, M. F., Vasquez, D. N., Vaughan, D. J. A., Vinturache, A., Walker, J., Wardle, S. P., Wasim, T., Waters, J. H., Whitehead, C. L., Wolfson, A., Yeo, S., Zermansky, A. G., (iHOPE), International Collaboration to Harmonise Outcomes for Pre-eclampsia, Life Course Epidemiology (LCE), University of Oxford, University College London, King’s College London, Academic Medical Center, Imperial College London, St George Hospital and University of New South Wales, Northwestern University, Cedars-Sinai Medical Center, London North West University Healthcare NHS Trust, Monash University, University of Adelaide, Barts and The London School of Medicine and Dentistry, University of Sheffield, University of Liverpool, Centro Rosarino de Estudios Perinatales, Chelsea and Westminster Hospital NHS Foundation Trust, Babcock University, Ailem Academic Counselling, KU Leuven, Universidad Nacional de Colombia, Northwell Health, Université de Montréal, University of Montreal Hospital Centre, Ondokuz Mayıs University, Prince Sultan Military Medical City, Postgraduate Institute of Medical Education and Research, Fetal Medicine Research Institute, University Hospital Limerick, Drexel University, University of Aberdeen, University of Groningen, University of Auckland, Haaglanden Medisch Centrum, Nottingham University Medical School, Utrecht University, King Edward Memorial Hospital for Women, Imperial College Healthcare NHS Trust, Jean-Verdier Hospital, Downland Practice, Universidade Estadual de Campinas (UNICAMP), Université Lyon, University of North Carolina School of Medicine, South Ural State Medical University, Stellenbosch University, Irish Neonatal Health Alliance, University of Rzeszow, Royal Brisbane and Women’s Hospital, Nottingham University Hospitals NHS Trust, University Hospitals of Leicester, North Bristol NHS Trust, University of Nottingham, Soroka University Medical Center Ben Gurion University of the Negev, St George’s University Hospitals NHS Foundation Trust, Hospitalsenhed Midt, University of Glasgow, Amsterdam Universitair Medische Centra, All India Institute of Medical Sciences Patna, Luton and Dunstable University Hospital, Khyber Medical University Institution of Medical Sciences, Midwife Mid Essex Hospitals NHS Trust, University of Oulu, University of Michigan, Bastyr University, Irish Nurses and Midwives Organisation, University of Toronto, Barts Health NHS Trust, University Hospitals Plymouth NHS Trust, Burnet Institute, Aga Khan University, Medical University of Graz, Homerton University Hospital NHS Foundation Trust, Mount Royal University, Université de Paris, Royal Surrey County Hospital, University Hospital Southampton NHS Foundation Trust, University of Washington School of Nursing, Evelina London Children's Hospital Neonatal Unit, University of Sydney, University of Leicester, Academic Hospital of Udine, NHS Borders, Weill Cornell Medical College, University of Dundee, University of Edinburgh, South Australian Health and Medical Research Institute, Monash University and Monash Health, United Lincolnshire Hospitals NHS Trust, University of Kwa Zulu-Natal, Beatrix Hospital, Keele University, Government Medical College, Institut Catala de la Salut. IdiapJgol, National Center for Child Health and Development, Basavatarakam Indo-American Cancer Hospital and Research Institute, Axon Anaesthesia Associates, Pennine Acute Hospitals NHS Trust, University of London, Norfolk and Norwich University Hospital, Jichi Medical University School of Medicine, Universidade Estadual Paulista (UNESP), National Institute of Public Health, University of Kyrenia, King Edward Memorial Hospital, Amsterdam University Centres, University of British Columbia, Chulalongkorn University, University of Brescia, University Of British Columbia, University of Montreal, Women's Clinic of Tartu University Hospital, Universidade Federal de São Paulo (UNIFESP), Université de Sherbrooke, University Hospital of Wales, University of Iowa, King's College London, Westmead Hospital, Princess Royal Maternity, Leipzig University, Centre Hospitalier Public du Cotentin, Lewisham and Greenwich NHS Trust, Juntendo University Faculty of Medicine, Western Sydney University, National Institute of Health Research, University of Washington, Baylor College of Medicine, Capelle aan den Ijssel, Sanatorio Anchorena, Oxford University Hospitals NHS Foundation Trust, University of Leeds, Institute of Medical Sciences, UPMC Magee Womens Hospital, Penn Medicine Princeton Health, University of North Carolina at Chapel Hill, and Obstetrics and Gynaecology

Subjects
Adult, medicine.medical_specialty, Consensus, Delphi Technique, Standardization, Birth weight, Psychological intervention, Randomised controlled trials, 030204 cardiovascular system & hematology, Outcome (game theory), 03 medical and health sciences, Hypertension in pregnancy, Outcome measure, 0302 clinical medicine, Pre-Eclampsia, Pregnancy, Consensus development study, Internal Medicine, medicine, Humans, Set (psychology), 030219 obstetrics & reproductive medicine, Eclampsia, business.industry, Pregnancy Outcome, Obstetrics and Gynecology, Core outcome set, Reference Standards, medicine.disease, Pre-eclampsia, Pregnancy Complications, Core (game theory), Treatment Outcome, Systematic review, Family medicine, 1114 Paediatrics and Reproductive Medicine, Female, International Collaboration to Harmonise Outcomes for Pre-eclampsia (iHOPE), business
Abstract

Made available in DSpace on 2022-04-28T19:29:02Z (GMT). No. of bitstreams: 0 Previous issue date: 2020-07-01 Medical Research Council Canada National Institute for Health Research Objectives: To develop consensus definitions for the core outcome set for pre-eclampsia. Study design: Potential definitions for individual core outcomes were identified across four formal definition development initiatives, nine national and international guidelines, 12 Cochrane systematic reviews, and 79 randomised trials. Eighty-six definitions were entered into the consensus development meeting. Ten healthcare professionals and three researchers, including six participants who had experience of conducting research in low- and middle-income countries, participated in the consensus development process. The final core outcome set was approved by an international steering group. Results: Consensus definitions were developed for all core outcomes. When considering stroke, pulmonary oedema, acute kidney injury, raised liver enzymes, low platelets, birth weight, and neonatal seizures, consensus definitions were developed specifically for low- and middle-income countries because of the limited availability of diagnostic interventions including computerised tomography, chest x-ray, laboratory tests, equipment, and electroencephalogram monitoring. Conclusions: Consensus on measurements for the pre-eclampsia core outcome set will help to ensure consistency across future randomised trials and systematic reviews. Such standardization should make research evidence more accessible and facilitate the translation of research into clinical practice. Video abstract can be available at: www.dropbox.com/s/ftrgvrfu0u9glqd/6.%20Standardising%20definitions%20in%20teh%20pre-eclampsia%20core%20outcome%20set%3A%20a%20consensus%20development%20study.mp4?dl=0. Nuffield Department of Primary Care Health Sciences University of Oxford Institute for Women’s Health University College London Department of Women and Children’s Health School of Life Course Sciences King’s College London Department of Obstetrics and Gynecology Amsterdam UMC Academic Medical Center Academic Neonatal Medicine Imperial College London Department of Renal Medicine St George Hospital and University of New South Wales Department of Obstetrics and Gynaecology Feinberg School of Medicine Northwestern University Health Services Research Unit Nuffield Department of Population Health University of Oxford Cedars-Sinai Medical Center London North West University Healthcare NHS Trust Women’s Health Care Research Group Department of Obstetrics and Gynaecology Monash University Department of Obstetrics and Gynaecology University of Adelaide Women’s Health Research Unit Barts and The London School of Medicine and Dentistry School of Health and Related Research University of Sheffield MRC North West Hub for Trials Methodology Research Department of Biostatistics University of Liverpool Centro Rosarino de Estudios Perinatales Chelsea and Westminster Hospital NHS Foundation Trust Babcock University Ailem Academic Counselling KU Leuven Universidad Nacional de Colombia Northwell Health University of Oxford Université de Montréal University of Montreal Hospital Centre Ondokuz Mayıs University Prince Sultan Military Medical City Postgraduate Institute of Medical Education and Research King's Fertility Fetal Medicine Research Institute University Hospital Limerick Drexel University University of Aberdeen University of Groningen University of Auckland Haaglanden Medisch Centrum Nottingham University Medical School Utrecht University King Edward Memorial Hospital for Women Imperial College Healthcare NHS Trust Jean-Verdier Hospital Downland Practice University of Campinas Université Lyon University of North Carolina School of Medicine South Ural State Medical University Stellenbosch University Irish Neonatal Health Alliance University of Rzeszow Royal Brisbane and Women’s Hospital Nottingham University Hospitals NHS Trust University Hospitals of Leicester North Bristol NHS Trust University of Nottingham Soroka University Medical Center Ben Gurion University of the Negev St George’s University Hospitals NHS Foundation Trust Hospitalsenhed Midt University of Glasgow Amsterdam Universitair Medische Centra All India Institute of Medical Sciences Patna Luton and Dunstable University Hospital Khyber Medical University Institution of Medical Sciences Midwife Mid Essex Hospitals NHS Trust University of Oulu University of Michigan Bastyr University Irish Nurses and Midwives Organisation University of Toronto Barts Health NHS Trust University Hospitals Plymouth NHS Trust Burnet Institute Aga Khan University Medical University of Graz Homerton University Hospital NHS Foundation Trust Mount Royal University Université de Paris Royal Surrey County Hospital University Hospital Southampton NHS Foundation Trust University of Washington School of Nursing Evelina London Children's Hospital Neonatal Unit University of Sydney University of Leicester Academic Hospital of Udine NHS Borders Weill Cornell Medical College University of Dundee University of Edinburgh South Australian Health and Medical Research Institute University of Sheffield Monash University and Monash Health United Lincolnshire Hospitals NHS Trust University of Kwa Zulu-Natal Beatrix Hospital Keele University Government Medical College Institut Catala de la Salut. IdiapJgol University College London National Center for Child Health and Development Basavatarakam Indo-American Cancer Hospital and Research Institute Axon Anaesthesia Associates Pennine Acute Hospitals NHS Trust St George's University of London Norfolk and Norwich University Hospital Jichi Medical University School of Medicine São Paulo State University National Institute of Public Health University of Kyrenia King Edward Memorial Hospital Amsterdam University Centres University of British Columbia Chulalongkorn University University of Brescia University Of British Columbia University of Montreal Women's Clinic of Tartu University Hospital Universidade Federal de São Paulo Université de Sherbrooke University Hospital of Wales University of Iowa King's College London Westmead Hospital Princess Royal Maternity Leipzig University Centre Hospitalier Public du Cotentin Lewisham and Greenwich NHS Trust Juntendo University Faculty of Medicine Western Sydney University National Institute of Health Research University of Washington Baylor College of Medicine Capelle aan den Ijssel Sanatorio Anchorena Oxford University Hospitals NHS Foundation Trust University of Leeds Institute of Medical Sciences UPMC Magee Womens Hospital Penn Medicine Princeton Health University of North Carolina at Chapel Hill São Paulo State University

Published
2020
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10. A core outcome set for pre-eclampsia research: an international consensus development study

Author

Duffy, J. M. N., Cairns, A. E., Richards-Doran, D., van 't Hooft, J., Gale, C., Brown, M., Chappell, L. C., Grobman, W. A., Fitzpatrick, R., Karumanchi, S. A., Khalil, A., Lucas, D. N., Magee, L. A., Mol, B. W., Stark, M., Thangaratinam, S., Wilson, M. J., von Dadelszen, P., Williamson, P. R., Ziebland, S., Mcmanus, R. J., Abalos, E. J., C. C. D., Da, Akadr, A. A., Akturk, Z., Allegaert, K., Angel-Muller, E., Antretter, J., Ashdown, H. F., Audibert, F., Auger, N., Aygun, C., Babic, I., Bagga, R., Baker, J. M., Bhakta, P., Bhandari, V., Bhattacharya, S., Blanker, M. H., Bloomfield, F. H., Bof, A., Brennan, S. M., Broekhuijsen, K., Pipkin, E. F. B., Browne, J. L., Browning, R. M., Bull, J. W., Butt, A., Button, D., Campbell, J. P., Campbell, D. M., Carbillon, L., Carthy, S., Casely, E., Cave, J. A., Cecatti, J. G., Chamillard, M. E., Chassard, D., Checheir, N. C., Chulkov, V. S., Cluver, C. A., Crawford, C. F., Daly, M. C., Darmochwal-Kolarz, D. A., Davies, R. E., Davies, M. W., Dawson, J. S., Dobson, N., Dodd, C. N., Donald, F., Duley, L., Epstein-Mares, J., Erez, O., Evans, E., Farlie, R. N., Ferris, A. V., Frankland, E. M., Freeman, D. J., Gainder, S., Ganzevoort, W., Gbinigie, O. A., Ghosh, S. K., Glogowska, M., Goodlife, A., Gough, K. L., Green, J. R., Gul, F., Haggerty, L., Hall, D. R., Hallman, M., Hamilton, L. M., Hammond, S. J., Harlow, S. D., Hays, K. E., Hickey, S. C., Higgins, M., Hinton, L., Hobson, S. R., Hogg, M. J., Hollands, H. J., C. S. E., Eh, Hoodbhoy, Z., Howell, P., Huppertz, B., Husain, S., Jacoby, S. D., Jacqz-Aigrain, E., Jenkins, G., Jewel, D., Johnson, M. J., Johnston, C. L., Jones, P. M., Kantrowitz-Gordon, I., Khan, R. -U., Kirby, L. J., Kirk, C., Knight, M., Korey, M. T., Lee, G. J., Lee, V. W., Levene, L. S., Londero, A. P., Lust, K. M., Mackenzie, V., Malha, L., Mattone, M., Mccartney, D. E., Mcfadden, A., Mckinstry, B. H., Middleton, P. F., Mistry, H. D., Mitchell, C. A., Mockler, J. C., Molsher, S. -A., Monast, E. S., Moodley, E. J., Mooij, R., Moore, E. L., Morgan, L., Moulson, A., Mughal, F., Mundle, S. R., Munoz, M. A., Murray, E., Nagata, C., Nair, A. S., Nakimuli, A., Nath, G., Newport, R. S., Oakeshott, P., Ochoa-Ferraro, M. R., Odendaal, H., Ohkuchi, A., Oliveira, L., Ortiz-Panozo, E., Oudijk, M. A., Oygucu, S. E., Paech, M. J., Painter, R. C., Parry, C. L., Payne, B. A., Pearson, E. L., Phupong, V., Pickett, N., Pickles, K. A., Plumb, L. K., Prefumo, F., Preston, R., Ray, J. G., Rayment, J., Regan, L. V., Rey, E., Robson, E. J., Rubin, A. N., Rubio-Romero, A. N., Rull, K., Sass, N., Sauve, N., Savory, N. A., Scott, J. R., Seaton, S. E., Seed, P. T., Shakespeare, J. M., Shand, A. W., Sharma, S., Shaw, T. Y., Smedley, K. L., Smith, D., Conk, A. S., Soward, D., Stepan, H., Stroumpoulis, K., Surendr, A., Takeda, S., Tan, L., Theriot, B. S., Thomas, H. F., Thompson, K., Thompson, P. I., Thompson, M. J., Toms, L., Torney, K. L. H. T., Treadwell, J. S., Tucker, K. L., Turrentine, M. A., Van Hecke, O., Van Oostwaard, M. F., Vasquez, D. N., D. J. A., Av, Vinturache, A., Walker, J., Wardle, S. P., Wasim, T., Waters, J. H., Whitehead, C. L., Wolfson, A., Yeo, S., Obstetrics and Gynaecology, Life Course Epidemiology (LCE), University of Oxford, University College London, Academic Medical Centre, Imperial College London, St George Hospital and University of New South Wales, King's College London, Northwestern University, Cedars-Sinai Medical Center, St George's University of London, London North West University Healthcare NHS Trust, Monash University, University of Adelaide, Barts and the London School of Medicine and Dentistry, University of Sheffield, University of Liverpool, Centro Rosarino de Estudios Perinatales, Chelsea and Westminster Hospital NHS Foundation Trust, Babcock University, Ailem Academic Counselling, KU Leuven, Universidad Nacional de Colombia, Northwell Health, Université de Montréal, University of Montreal Hospital Centre, Ondokuz Mayis University, Prince Sultan Military Medical City, Chandigarh, University Hospital Limerick, Drexel University, University of Aberdeen, University of Groningen, University of Auckland, Haaglanden Medisch Centrum, Nottingham University Medical School, Utrecht University, King Edward Memorial Hospital for Women, Imperial College Healthcare NHS Trust, Jean-Verdier Hospital, Downland Practice, Universidade Estadual de Campinas (UNICAMP), Université Lyon, University of North Carolina School of Medicine, South Ural State Medical University, Stellenbosch University, Irish Neonatal Health Alliance, University of Rzeszow, Royal Brisbane and Women's Hospital, Nottingham University Hospitals NHS Trust, University Hospitals of Leicester, North Bristol NHS Trust, University of Nottingham, Soroka University Medical Centre Ben Gurion University of the Negev, St George's University Hospitals NHS Foundation Trust, Hospitalsenhed Midt, University of Glasgow, Postgraduate Institute of Medical Education and Research, Amsterdam Universitair Medische Centra, All India Institute of Medical Sciences Patna, Luton and Dunstable University Hospital, Khyber Medical University Institution of Medical Sciences, Midwife Mid Essex Hospitals NHS Trust, University of Oulu, University of Michigan, Bastyr University, Irish Nurses and Midwives Organisation, University of Toronto, Barts Health NHS Trust, University Hospitals Plymouth NHS Trust, Burnet Institute, Aga Khan University, Medical University of Graz, Homerton University Hospital NHS Foundation Trust, Mount Royal University, Université de Paris, Royal Surrey County Hospital, University Hospital Southampton NHS Foundation Trust, University of Washington School of Nursing, Evelina London Children's Hospital Neonatal Unit, University of Sydney, University of Leicester, Academic Hospital of Udine, NHS Borders, Weill Cornell Medical College, University of Dundee, University of Edinburgh, South Australian Health and Medical Research Institute, Monash University and Monash Health, United Lincolnshire Hospitals NHS Trust, University of Kwa Zulu-Natal, Beatrix Hospital, Keele University, Nagpur, Institut Catala de la Salut. IdiapJgol, National Centre for Child Health and Development, Basavatarakam Indo-American Cancer Hospital and Research Institute, Axon Anaesthesia Associates, Pennine Acute Hospitals NHS Trust, University of London, Norfolk and Norwich University Hospital, Jichi Medical University School of Medicine, Universidade Estadual Paulista (UNESP), National Institute of Public Health, University of Kyrenia, King Edward Memorial Hospital, Amsterdam University Centres, University of British Columbia, Chulalongkorn University, University of Brescia, University of Montreal, Women's Clinic of Tartu University Hospital, Universidade Federal de São Paulo (UNIFESP), Université de Sherbrooke, University Hospital of Wales, University of Iowa, Westmead Hospital, Princess Royal Maternity, Leipzig University, Centre Hospitalier Public du Cotentin, Lewisham and Greenwich NHS Trust, Juntendo University Faculty of Medicine, Western Sydney University, National Institute of Health Research, University of Washington, Baylor College of Medicine, Capelle aan den Ijssel, Sanatorio Anchorena, Oxford University Hospitals NHS Foundation Trust, University of Leeds, Lahore, UPMC Magee Womens Hospital, and Penn Medicine Princeton Health

Subjects
PROTOCOL, medicine.medical_specialty, pre-eclampsia, Biomedical Research, Consensus development study, core outcome set, modified Delphi method, modified nominal group technique, outcome reporting bias, Female, Humans, International Cooperation, Pre-Eclampsia, Pregnancy, Pregnancy Outcome, Population, GUIDELINES, RECOMMENDATIONS, Obstetrics and gynaecology, Intensive care, Nominal group technique, medicine, Obstetrics & Reproductive Medicine, Intensive care medicine, education, 11 Medical and Health Sciences, reproductive and urinary physiology, education.field_of_study, Science & Technology, Eclampsia, business.industry, Obstetrics & Gynecology, Obstetrics and Gynecology, Gestational age, medicine.disease, TRIALS, Systematic review, International Collaboration to Harmonise Outcomes for Pre-eclampsia (iHOPE), Thematic analysis, business, Life Sciences & Biomedicine
Abstract

Made available in DSpace on 2022-04-28T19:28:54Z (GMT). No. of bitstreams: 0 Previous issue date: 2020-11-01 National Institute for Health Research Barts Charity Objective: To develop a core outcome set for pre-eclampsia. Design: Consensus development study. Setting: International. Population: Two hundred and eight-one healthcare professionals, 41 researchers and 110 patients, representing 56 countries, participated. Methods: Modified Delphi method and Modified Nominal Group Technique. Results: A long-list of 116 potential core outcomes was developed by combining the outcomes reported in 79 pre-eclampsia trials with those derived from thematic analysis of 30 in-depth interviews of women with lived experience of pre-eclampsia. Forty-seven consensus outcomes were identified from the Delphi process following which 14 maternal and eight offspring core outcomes were agreed at the consensus development meeting. Maternal core outcomes: death, eclampsia, stroke, cortical blindness, retinal detachment, pulmonary oedema, acute kidney injury, liver haematoma or rupture, abruption, postpartum haemorrhage, raised liver enzymes, low platelets, admission to intensive care required, and intubation and ventilation. Offspring core outcomes: stillbirth, gestational age at delivery, birthweight, small-for-gestational-age, neonatal mortality, seizures, admission to neonatal unit required and respiratory support. Conclusions: The core outcome set for pre-eclampsia should underpin future randomised trials and systematic reviews. Such implementation should ensure that future research holds the necessary reach and relevance to inform clinical practice, enhance women's care and improve the outcomes of pregnant women and their babies. Tweetable abstract: 281 healthcare professionals, 41 researchers and 110 women have developed #preeclampsia core outcomes @HOPEoutcomes @jamesmnduffy. [Correction added on 29 June 2020, after first online publication: the order has been corrected.]. Nuffield Department of Primary Care Health Sciences University of Oxford Institute for Women's Health University College London Department of Obstetrics and Gynaecology Amsterdam UMC Academic Medical Centre Academic Neonatal Medicine Imperial College London Department of Renal Medicine St George Hospital and University of New South Wales Department of Women and Children's Health School of Life Course Sciences King's College London Department of Obstetrics and Gynecology Feinberg School of Medicine Northwestern University Health Services Research Unit Nuffield Department of Population Health University of Oxford Cedars-Sinai Medical Center Vascular Biology Research Centre Molecular and Clinical Sciences Research Institute St George's University of London London North West University Healthcare NHS Trust Department of Obstetrics and Gynaecology Monash University Department of Obstetrics and Gynaecology University of Adelaide Women's Health Research Unit Barts and the London School of Medicine and Dentistry School of Health and Related Research University of Sheffield MRC North West Hub for Trials Methodology Research Department of Biostatistics University of Liverpool Centro Rosarino de Estudios Perinatales Chelsea and Westminster Hospital NHS Foundation Trust Babcock University Ailem Academic Counselling KU Leuven Universidad Nacional de Colombia Northwell Health University of Oxford Université de Montréal University of Montreal Hospital Centre Ondokuz Mayis University Prince Sultan Military Medical City Postgraduate Institute of Medical Education and Research Chandigarh University Hospital Limerick Drexel University University of Aberdeen University of Groningen University of Auckland Haaglanden Medisch Centrum Nottingham University Medical School Utrecht University King Edward Memorial Hospital for Women Imperial College Healthcare NHS Trust Jean-Verdier Hospital Downland Practice University of Campinas Université Lyon University of North Carolina School of Medicine South Ural State Medical University Stellenbosch University Irish Neonatal Health Alliance University of Rzeszow Royal Brisbane and Women's Hospital Nottingham University Hospitals NHS Trust University Hospitals of Leicester North Bristol NHS Trust University of Nottingham Soroka University Medical Centre Ben Gurion University of the Negev St George's University Hospitals NHS Foundation Trust Hospitalsenhed Midt University of Glasgow Postgraduate Institute of Medical Education and Research Amsterdam Universitair Medische Centra All India Institute of Medical Sciences Patna Luton and Dunstable University Hospital Khyber Medical University Institution of Medical Sciences Midwife Mid Essex Hospitals NHS Trust University of Oulu University of Michigan Bastyr University Irish Nurses and Midwives Organisation University of Toronto Barts Health NHS Trust University Hospitals Plymouth NHS Trust Burnet Institute Aga Khan University Medical University of Graz Homerton University Hospital NHS Foundation Trust Mount Royal University Université de Paris Royal Surrey County Hospital University Hospital Southampton NHS Foundation Trust University of Washington School of Nursing Evelina London Children's Hospital Neonatal Unit University of Sydney University of Leicester Academic Hospital of Udine NHS Borders Weill Cornell Medical College University of Dundee University of Edinburgh South Australian Health and Medical Research Institute University of Sheffield Monash University and Monash Health United Lincolnshire Hospitals NHS Trust University of Kwa Zulu-Natal Beatrix Hospital Keele University Government Medical College Nagpur Institut Catala de la Salut. IdiapJgol University College London National Centre for Child Health and Development Basavatarakam Indo-American Cancer Hospital and Research Institute Axon Anaesthesia Associates Pennine Acute Hospitals NHS Trust St George's University of London Norfolk and Norwich University Hospital Jichi Medical University School of Medicine São Paulo State University National Institute of Public Health University of Kyrenia King Edward Memorial Hospital Amsterdam University Centres University of British Columbia Chulalongkorn University University of Brescia University of Montreal Women's Clinic of Tartu University Hospital Universidade Federal de São Paulo Université de Sherbrooke University Hospital of Wales University of Iowa King's College London Westmead Hospital Princess Royal Maternity Leipzig University Centre Hospitalier Public du Cotentin Lewisham and Greenwich NHS Trust Juntendo University Faculty of Medicine Western Sydney University National Institute of Health Research University of Washington Baylor College of Medicine Capelle aan den Ijssel Sanatorio Anchorena Oxford University Hospitals NHS Foundation Trust University of Leeds Institute of Medical Sciences Lahore UPMC Magee Womens Hospital Penn Medicine Princeton Health University of North Carolina at Chapel Hill USA and Dr Arnold G. Zermansky University of Leeds São Paulo State University

Published
2020

13. Maternal and neonatal outcomes in women with severe early onset pre-eclampsia before 26 weeks of gestation, a case series

Author

van Oostwaard, M F, van Eerden, L, de Laat, M W, Duvekot, J J, Erwich, Jjhm, Bloemenkamp, Kwm, Bolte, A C, Bosma, Jpf, Koenen, S V, Kornelisse, R F, Rethans, B, van Runnard Heimel, P, Scheepers, Hcj, Ganzevoort, W, Mol, Bwj, de Groot, C J, Gaugler-Senden, Ipm, van Oostwaard, M F, van Eerden, L, de Laat, M W, Duvekot, J J, Erwich, Jjhm, Bloemenkamp, Kwm, Bolte, A C, Bosma, Jpf, Koenen, S V, Kornelisse, R F, Rethans, B, van Runnard Heimel, P, Scheepers, Hcj, Ganzevoort, W, Mol, Bwj, de Groot, C J, and Gaugler-Senden, Ipm

Published
2017

14. Maternal and neonatal outcomes in women with severe early onset pre-eclampsia before 26 weeks of gestation, a case series

Author

Unit Opleiding Aios, Geboortecentrum voorzitterschap, MS Verloskunde, Circulatory Health, van Oostwaard, M F, van Eerden, L, de Laat, M W, Duvekot, J J, Erwich, Jjhm, Bloemenkamp, Kwm, Bolte, A C, Bosma, Jpf, Koenen, S V, Kornelisse, R F, Rethans, B, van Runnard Heimel, P, Scheepers, Hcj, Ganzevoort, W, Mol, Bwj, de Groot, C J, Gaugler-Senden, Ipm, Unit Opleiding Aios, Geboortecentrum voorzitterschap, MS Verloskunde, Circulatory Health, van Oostwaard, M F, van Eerden, L, de Laat, M W, Duvekot, J J, Erwich, Jjhm, Bloemenkamp, Kwm, Bolte, A C, Bosma, Jpf, Koenen, S V, Kornelisse, R F, Rethans, B, van Runnard Heimel, P, Scheepers, Hcj, Ganzevoort, W, Mol, Bwj, de Groot, C J, and Gaugler-Senden, Ipm

Published
2017

15. Richtlijn osteoporose en fractuurpreventie

Author

Lems, W.F., Post, P. N., van den Bergh, J.P.W., Cornelder, H. W., Elders, P.J.M., Geusens, P.P.M., Ginai, A. Z., Groen, M., Hegeman, J. H., van Helden, S.H., Leusink, G.L., Ligthart, M. G. C., Lips, P. T. A. M., de Nijs, R. N. J. T. L., van Roermund, P. M., Scheffer, A. C. L., Thomas, S., Verhaar, H.J.J., van der Zalm-Waterrreus, M. A., Chel, V. G. M., Franke, H. R., Hendriks, H.J.M., Kievit, W., Pelger, R. C. M., Reyners, A. K. L., Rommers, G.M., van Oostwaard, M. M., Rosenbrand, C.J.G.M., van der Es-Lambeek, L. C., Interne Geneeskunde, Surgery, Epidemiologie, RS: CAPHRI School for Public Health and Primary Care, and RS: NUTRIM - R2 - Gut-liver homeostasis

Published
2011

17. Recurrence of hypertensive disorders of pregnancy: An individual patient data metaanalysis

Author

Van Oostwaard, M, Langenveld, J, Schuit, E, Papatsonis, D, Brown, M, Byaruhanga, R, Bhattacharya, S, Campbell, D, Chappell, L, Chiaffarino, F, Crippa, I, Facchinetti, F, Ferrazzani, S, Ferrazzi, E, Figueiró Filho, E, Gaugler Senden, I, Haavaldsen, C, Lykke, J, Mbah, A, Oliveira, V, Poston, L, Redman, C, Salim, R, Thilaganathan, B, Vergani, P, Zhang, J, Steegers, E, Mol, B, Ganzevoort, W, VERGANI, PATRIZIA, Ganzevoort, W., Van Oostwaard, M, Langenveld, J, Schuit, E, Papatsonis, D, Brown, M, Byaruhanga, R, Bhattacharya, S, Campbell, D, Chappell, L, Chiaffarino, F, Crippa, I, Facchinetti, F, Ferrazzani, S, Ferrazzi, E, Figueiró Filho, E, Gaugler Senden, I, Haavaldsen, C, Lykke, J, Mbah, A, Oliveira, V, Poston, L, Redman, C, Salim, R, Thilaganathan, B, Vergani, P, Zhang, J, Steegers, E, Mol, B, Ganzevoort, W, VERGANI, PATRIZIA, and Ganzevoort, W.

Abstract

Objective We performed an individual participant data (IPD) metaanalysis to calculate the recurrence risk of hypertensive disorders of pregnancy (HDP) and recurrence of individual hypertensive syndromes. Study Design We performed an electronic literature search for cohort studies that reported on women experiencing HDP and who had a subsequent pregnancy. The principal investigators were contacted and informed of our study; we requested their original study data. The data were merged to form one combined database. The results will be presented as percentages with 95% confidence interval (CI) and odds ratios with 95% CI. Results Of 94 eligible cohort studies, we obtained IPD of 22 studies, including a total of 99,415 women. Pooled data of 64 studies that used published data (IPD where available) showed a recurrence rate of 18.1% (n = 152,213; 95% CI, 17.9-18.3%). In the 22 studies that are included in our IPD, the recurrence rate of a HDP was 20.7% (95% CI, 20.4-20.9%). Recurrence manifested as preeclampsia in 13.8% of the studies (95% CI,13.6-14.1%), gestational hypertension in 8.6% of the studies (95% CI, 8.4-8.8%) and hemolysis, elevated liver enzymes and low platelets (HELLP) syndrome in 0.2% of the studies (95% CI, 0.16-0.25%). The delivery of a small-for-gestational-age child accompanied the recurrent HDP in 3.4% of the studies (95% CI, 3.2-3.6%). Concomitant HELLP syndrome or delivery of a small-for-gestational-age child increased the risk of recurrence of HDP. Recurrence increased with decreasing gestational age at delivery in the index pregnancy. If the HDP recurred, in general it was milder, regarding maximum diastolic blood pressure, proteinuria, the use of oral antihypertensive and anticonvulsive medication, the delivery of a small-for-gestational-age child, premature delivery, and perinatal death. Normotensive women experienced chronic hypertension after pregnancy more often after experiencing recurrence (odds ratio, 3.7; 95% CI, 2.3-6.1). Conclusion Amon

Published
2015

18. Maternal and neonatal outcomes in women with severe early onset pre-eclampsia before 26 weeks of gestation, a case series.

Author

Oostwaard, MF, Eerden, L, Laat, MW, Duvekot, JJ, Erwich, JJHM, Bloemenkamp, KWM, Bolte, AC, Bosma, JPF, Koenen, SV, Kornelisse, RF, Rethans, B, Runnard Heimel, P, Scheepers, HCJ, Ganzevoort, W, Mol, BWJ, Groot, CJ, Gaugler‐Senden, IPM, van Oostwaard, M F, van Eerden, L, and de Laat, M W

Subjects
PREGNANCY, EDEMA, PLACENTA, RETROLENTAL fibroplasia, KIDNEY failure
Abstract

Objective: To describe the maternal and neonatal outcomes and prolongation of pregnancies with severe early onset pre-eclampsia before 26 weeks of gestation.Design: Nationwide case series.Setting: All Dutch tertiary perinatal care centres.Population: All women diagnosed with severe pre-eclampsia who delivered between 22 and 26 weeks of gestation in a tertiary perinatal care centre in the Netherlands, between 2008 and 2014.Methods: Women were identified through computerised hospital databases. Data were collected from medical records.Main Outcome Measures: Maternal complications [HELLP (haemolysis, elevated liver enzyme levels, and low platelet levels) syndrome, eclampsia, pulmonary oedema, cerebrovascular incidents, hepatic capsular rupture, placenta abruption, renal failure, and maternal death], neonatal survival and complications (intraventricular haemorrhage, retinopathy of prematurity, necrotising enterocolitis, bronchopulmonary dysplasia, and sepsis), and outcome of subsequent pregnancies (recurrent pre-eclampsia, premature delivery, and neonatal survival).Results: We studied 133 women, delivering 140 children. Maternal complications occurred frequently (54%). Deterioration of HELLP syndrome during expectant care occurred in 48%, after 4 days. Median prolongation was 5 days (range: 0-25 days). Neonatal survival was poor (19%), and was worse (6.6%) if the mother was admitted before 24 weeks of gestation. Complications occurred frequently among survivors (84%). After active support, neonatal survival was comparable with the survival of spontaneous premature neonates (54%). Pre-eclampsia recurred in 31%, at a mean gestational age of 32 weeks and 6 days.Conclusions: Considering the limits of prolongation, women need to be counselled carefully, weighing the high risk for maternal complications versus limited neonatal survival and/or extreme prematurity and its sequelae. The positive prospects regarding maternal and neonatal outcome in future pregnancies can supplement counselling.Tweetable Abstract: Severe early onset pre-eclampsia comes with high maternal complication rates and poor neonatal survival. [ABSTRACT FROM AUTHOR]

Published
2017
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19. Recurrence of hypertensive disorders of pregnancy: an individual patient data metaanalysis

Author

Sergio Ferrazzani, Vanessa Marcon de Oliveira, Alfred K. Mbah, Romano N. Byaruhanga, Baskaran Thilaganathan, Miriam F. van Oostwaard, Doris M. Campbell, Lucy C Chappell, Ernesto Antonio Figueiró-Filho, Ingrid P.M. Gaugler-Senden, Francesca Chiaffarino, Jacob Alexander Lykke, Christopher W.G. Redman, Ewoud Schuit, Patrizia Vergani, Lucilla Poston, Wessel Ganzevoort, Fabio Facchinetti, Dimitri N.M. Papatsonis, Jun Zhang, Isabella Crippa, Sohinee Bhattacharya, Enrico Ferrazzi, Mark Brown, Eric A.P. Steegers, Camilla Haavaldsen, Raed Salim, Josje Langenveld, Ben W.J. Mol, Other departments, Obstetrics and Gynaecology, APH - Amsterdam Public Health, Obstetrics & Gynecology, Van Oostwaard, M, Langenveld, J, Schuit, E, Papatsonis, D, Brown, M, Byaruhanga, R, Bhattacharya, S, Campbell, D, Chappell, L, Chiaffarino, F, Crippa, I, Facchinetti, F, Ferrazzani, S, Ferrazzi, E, Figueiró Filho, E, Gaugler Senden, I, Haavaldsen, C, Lykke, J, Mbah, A, Oliveira, V, Poston, L, Redman, C, Salim, R, Thilaganathan, B, Vergani, P, Zhang, J, Steegers, E, Mol, B, and Ganzevoort, W

Subjects
Gestational hypertension, HELLP syndrome, IPD, gestational hypertension, preeclampsia, pregnancy, recurrence, Adult, Anticonvulsants, Antihypertensive Agents, Chronic Disease, Cohort Studies, Female, HELLP Syndrome, Humans, Hypertension, Hypertension, Pregnancy-Induced, Infant, Newborn, Infant, Small for Gestational Age, Postpartum Period, Pre-Eclampsia, Pregnancy, Premature Birth, Recurrence, Severity of Illness Index, Young Adult, Medicine(all), Obstetrics, Obstetrics and Gynecology, Gestational age, medicine.medical_specialty, Hypertension in Pregnancy, Pregnancy-Induced, Preeclampsia, medicine, Journal Article, Gynecology, Eclampsia, business.industry, Infant, Odds ratio, medicine.disease, Newborn, Settore MED/40 - GINECOLOGIA E OSTETRICIA, Small for Gestational Age, business, Meta-Analysis
Abstract

Objective We performed an individual participant data (IPD) metaanalysis to calculate the recurrence risk of hypertensive disorders of pregnancy (HDP) and recurrence of individual hypertensive syndromes. Study Design We performed an electronic literature search for cohort studies that reported on women experiencing HDP and who had a subsequent pregnancy. The principal investigators were contacted and informed of our study; we requested their original study data. The data were merged to form one combined database. The results will be presented as percentages with 95% confidence interval (CI) and odds ratios with 95% CI. Results Of 94 eligible cohort studies, we obtained IPD of 22 studies, including a total of 99,415 women. Pooled data of 64 studies that used published data (IPD where available) showed a recurrence rate of 18.1% (n = 152,213; 95% CI, 17.9–18.3%). In the 22 studies that are included in our IPD, the recurrence rate of a HDP was 20.7% (95% CI, 20.4–20.9%). Recurrence manifested as preeclampsia in 13.8% of the studies (95% CI,13.6–14.1%), gestational hypertension in 8.6% of the studies (95% CI, 8.4–8.8%) and hemolysis, elevated liver enzymes and low platelets (HELLP) syndrome in 0.2% of the studies (95% CI, 0.16–0.25%). The delivery of a small-for-gestational-age child accompanied the recurrent HDP in 3.4% of the studies (95% CI, 3.2–3.6%). Concomitant HELLP syndrome or delivery of a small-for-gestational-age child increased the risk of recurrence of HDP. Recurrence increased with decreasing gestational age at delivery in the index pregnancy. If the HDP recurred, in general it was milder, regarding maximum diastolic blood pressure, proteinuria, the use of oral antihypertensive and anticonvulsive medication, the delivery of a small-for-gestational-age child, premature delivery, and perinatal death. Normotensive women experienced chronic hypertension after pregnancy more often after experiencing recurrence (odds ratio, 3.7; 95% CI, 2.3–6.1). Conclusion Among women that experience hypertension in pregnancy, the recurrence rate in a next pregnancy is relatively low, and the course of disease is milder for most women with recurrent disease. These reassuring data should be used for shared decision-making in women who consider a new pregnancy after a pregnancy that was complicated by hypertension.

Published
2014

21. A quasi-experimental study about shared decision-making and motivational interviewing on patients with a recent fracture attending Fracture Liaison Services.

Author

Maas L, Hiligsmann M, Wyers CE, Bours S, van der Weijden T, van den Bergh JP, van Oostwaard M, van Kuijk SMJ, and Boonen A

Subjects
Humans, Female, Male, Aged, Fractures, Bone therapy, Middle Aged, Motivational Interviewing, Decision Making, Shared
Abstract

Shared decision-making (SDM) aims to improve patients' experiences with care, treatment adherence, and health outcomes. However, the effectiveness of SDM in patients with a recent fracture who require anti-osteoporosis medication (AOM) is unclear. The objective of this study was to assess the effectiveness of a multicomponent adherence intervention (MCAI) including a patient decision aid (PDA) and motivational interviewing at Fracture Liaison Services (FLS) on multiple outcomes compared with usual care (UC). This pre-post superiority study included patients with a recent fracture attending FLS and with AOM treatment indication. The primary outcome was 1-year AOM persistence measured by pharmacy records. Secondary outcomes included treatment initiation, AOM adherence (measured by medication possession ratio [MPR]), decision quality (SDM process; 0-100, best), and decisional conflict (0-100, highest conflict), subsequent fractures, and mortality. Outcomes were tested in MCAI and UC groups at the first FLS visit and 4 and 12 months afterwards. Multiple imputation and uni- and multivariable analyses were performed. Post hoc analyses assessed the role of health literacy level. In total, 245 patients (MCAI: n = 136, UC: n = 109) were included. AOM persistence was 80.4% in the MCAI and 76.7% in the UC group (p=.626). SDM process scores were significantly better in MCAI (60.4 vs 55.1; p = .003). AOM initiation (97.8% vs 97.5%), MPR (90.9% vs 88.3%, p=.582), and decisional conflict (21.7 vs 23.0; p = .314) did not differ between groups. Results did not change importantly after adjustment. Stratified analyses by health literacy showed a better effect on MPR and SDM in those with adequate health literacy. This study showed no significant effect on AOM persistence; however, it demonstrated a significant positive effect of MCAI on SDM process in FLS attendees. (Netherlands Trial Registry, Trial NL7236 [NTR7435]; version 1.0; 26-11-2020 https://onderzoekmetmensen.nl/nl/trial/22858)., (© The Author(s) 2024. Published by Oxford University Press on behalf of the American Society for Bone and Mineral Research.)

Published
2024
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22. Development and validation of a prognostic model to predict birth weight: individual participant data meta-analysis.

Author

Allotey J, Archer L, Snell KIE, Coomar D, Massé J, Sletner L, Wolf H, Daskalakis G, Saito S, Ganzevoort W, Ohkuchi A, Mistry H, Farrar D, Mone F, Zhang J, Seed PT, Teede H, Da Silva Costa F, Souka AP, Smuk M, Ferrazzani S, Salvi S, Prefumo F, Gabbay-Benziv R, Nagata C, Takeda S, Sequeira E, Lapaire O, Cecatti JG, Morris RK, Baschat AA, Salvesen K, Smits L, Anggraini D, Rumbold A, van Gelder M, Coomarasamy A, Kingdom J, Heinonen S, Khalil A, Goffinet F, Haqnawaz S, Zamora J, Riley RD, Thangaratinam S, Kwong A, Savitri AI, Bhattacharya S, Uiterwaal CS, Staff AC, Andersen LB, Olive EL, Redman C, Macleod M, Thilaganathan B, Ramírez JA, Audibert F, Magnus PM, Jenum AK, McAuliffe FM, West J, Askie LM, Zimmerman PA, Riddell C, van de Post J, Illanes SE, Holzman C, van Kuijk SMJ, Carbillon L, Villa PM, Eskild A, Chappell L, Velauthar L, van Oostwaard M, Verlohren S, Poston L, Ferrazzi E, Vinter CA, Brown M, Vollebregt KC, Langenveld J, Widmer M, Haavaldsen C, Carroli G, Olsen J, Zavaleta N, Eisensee I, Vergani P, Lumbiganon P, Makrides M, Facchinetti F, Temmerman M, Gibson R, Frusca T, Norman JE, Figueiró-Filho EA, Laivuori H, Lykke JA, Conde-Agudelo A, Galindo A, Mbah A, Betran AP, Herraiz I, Trogstad L, Smith GGS, Steegers EAP, Salim R, Huang T, Adank A, Meschino WS, Browne JL, Allen RE, Klipstein-Grobusch K, Crowther CA, Jørgensen JS, Forest JC, Mol BW, Giguère Y, Kenny LC, Odibo AO, Myers J, Yeo S, McCowan L, Pajkrt E, Haddad BG, Dekker G, Kleinrouweler EC, LeCarpentier É, Roberts CT, Groen H, Skråstad RB, Eero K, Pilalis A, Souza RT, Hawkins LA, Figueras F, and Crovetto F

Abstract

Objective: To predict birth weight at various potential gestational ages of delivery based on data routinely available at the first antenatal visit., Design: Individual participant data meta-analysis., Data Sources: Individual participant data of four cohorts (237 228 pregnancies) from the International Prediction of Pregnancy Complications (IPPIC) network dataset., Eligibility Criteria for Selecting Studies: Studies in the IPPIC network were identified by searching major databases for studies reporting risk factors for adverse pregnancy outcomes, such as pre-eclampsia, fetal growth restriction, and stillbirth, from database inception to August 2019. Data of four IPPIC cohorts (237 228 pregnancies) from the US (National Institute of Child Health and Human Development, 2018; 233 483 pregnancies), UK (Allen et al, 2017; 1045 pregnancies), Norway (STORK Groruddalen research programme, 2010; 823 pregnancies), and Australia (Rumbold et al, 2006; 1877 pregnancies) were included in the development of the model., Results: The IPPIC birth weight model was developed with random intercept regression models with backward elimination for variable selection. Internal-external cross validation was performed to assess the study specific and pooled performance of the model, reported as calibration slope, calibration-in-the-large, and observed versus expected average birth weight ratio. Meta-analysis showed that the apparent performance of the model had good calibration (calibration slope 0.99, 95% confidence interval (CI) 0.88 to 1.10; calibration-in-the-large 44.5 g, -18.4 to 107.3) with an observed versus expected average birth weight ratio of 1.02 (95% CI 0.97 to 1.07). The proportion of variation in birth weight explained by the model (R 2 ) was 46.9% (range 32.7-56.1% in each cohort). On internal-external cross validation, the model showed good calibration and predictive performance when validated in three cohorts with a calibration slope of 0.90 (Allen cohort), 1.04 (STORK Groruddalen cohort), and 1.07 (Rumbold cohort), calibration-in-the-large of -22.3 g (Allen cohort), -33.42 (Rumbold cohort), and 86.4 g (STORK Groruddalen cohort), and observed versus expected ratio of 0.99 (Rumbold cohort), 1.00 (Allen cohort), and 1.03 (STORK Groruddalen cohort); respective pooled estimates were 1.00 (95% CI 0.78 to 1.23; calibration slope), 9.7 g (-154.3 to 173.8; calibration-in-the-large), and 1.00 (0.94 to 1.07; observed v expected ratio). The model predictions were more accurate (smaller mean square error) in the lower end of predicted birth weight, which is important in informing clinical decision making., Conclusions: The IPPIC birth weight model allowed birth weight predictions for a range of possible gestational ages. The model explained about 50% of individual variation in birth weights, was well calibrated (especially in babies at high risk of fetal growth restriction and its complications), and showed promising performance in four different populations included in the individual participant data meta-analysis. Further research to examine the generalisability of performance in other countries, settings, and subgroups is required., Trial Registration: PROSPERO CRD42019135045., Competing Interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from the National Institute for Health and Care Research Health Technology Assessment UK programme for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work., (Copyright © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2024
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23. Development and usability of a decision aid to initiate anti-osteoporosis medication treatment in patients visiting the fracture liaison service with a recent fracture.

Author

Maas L, Raskin N, van Onna M, Cornelissen D, Bours S, van der Weijden T, van den Bergh JP, van Oostwaard M, Wyers CE, Hiligsmann M, and Boonen A

Subjects
Humans, Female, Risk Factors, Decision Support Techniques, Osteoporotic Fractures prevention & control, Osteoporosis complications, Osteoporosis drug therapy, Spinal Fractures
Abstract

This study describes the development of a decision aid (DA), aimed at supporting patients in their decision whether to start anti-osteoporosis medication. People with recent fractures or osteoporosis and health professionals were supportive of the DA initiative. An experimental study been started to assess (cost-)effectiveness of the DA., Purpose: At fracture liaison services (FLS), patients with a recent fracture ánd osteoporosis or a prevalent vertebral fracture are advised to start anti-osteoporosis medication (AOM). This study describes the development of a decision aid (DA) to support patients and healthcare providers (HCPs) in their decision about whether to start AOM., Methods: The DA was developed according to International Patient Decision Aid Standards (IPDAS). A systematic procedure was chosen including scope, design, prototype development, and alpha testing. A previously developed DA for women with osteoporosis was used as a basis. Furthermore, input from literature searches, the Dutch guideline on management of osteoporosis, and from people with a fracture or osteoporosis was used. The updated DA was evaluated during alpha testing., Results: The DA facilitates the decision of patients whether to initiate AOM treatment and provides information on fractures and osteoporosis, general risk factors that increase the likelihood of a subsequent fracture, the role of lifestyle, personalized risk considerations of a subsequent fracture with and without AOM treatment, and AOM options and their characteristics in an option grid. Alpha testing with 15 patients revealed that patient preferences and needs were adequately presented, and several suggestions for improvement (e.g. adding more specific information, simplifying terminology, improving icon use) were accounted for. Participants from the alpha testing recommended use of the DA during outpatient visits., Conclusion: Professionals and persons with osteoporosis were supportive of the proposed DA and its usability. The DA could help in a shared decision-making process between patients and HCPs., (© 2023. The Author(s).)

Published
2024
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24. A head-to-head comparison of EQ-5D-5L and SF-6D in Dutch patients with fractures visiting a Fracture Liaison Service.

Author

Li N, Boonen A, van den Bergh JP, van Kuijk SMJ, Wyers CE, van Oostwaard M, Vranken L, Bours SPG, and Hiligsmann M

Subjects
Fractures, Bone physiopathology, Humans, Netherlands, Prospective Studies, Psychometrics, Reproducibility of Results, Statistics, Nonparametric, Surveys and Questionnaires, United Kingdom, Fractures, Bone psychology, Health Status, Quality of Life
Abstract

Aims: This study compared the psychometric properties of EQ-5D-5L and SF-6D to assess the interchangeability of both instruments in patients with a recent fracture presenting at a Fracture Liaison Service (FLS)., Materials and Methods: Data from a prospective observational study in a Dutch FLS clinic were used. Over 3 years, subjects were interviewed at several time points using EQ-5D-5L and SF-36. Floor and ceiling effects were evaluated. Agreement was evaluated by intra-class correlation coefficients and visualized in Bland-Altman plots. Spearman's rank correlation coefficients were applied to assess convergent validity. Mann-Whitney U test or Kruskal-Wallis H test as well as effect size (ES) were used to explore known-groups validity. Responsiveness was explored using standardized response mean (SRM) and ES. For each measurement property, hypotheses on direction and magnitude of effects were formulated., Results: A total of 499 patients were included. EQ-5D-5L had a considerable ceiling effect in comparison to SF-6D (21 vs. 1.2%). Moderate agreement between the (UK and Dutch) EQ-5D-5L and SF-6D was identified with intra-class correlation coefficients of 0.625 and 0.654, respectively. Bland-Altman plots revealed proportional bias as the differences in utilities between two instruments were highly dependent on the health states. High correlation between instruments was found (UK: rho = 0.758; Dutch: rho = 0.763). EQ-5D-5L and SF-6D utilities showed high correlation with physical component score but low correlation with mental component score of SF-36. Both instruments showed moderate discrimination (ES > 0.5) for subgroup by baseline fracture type, and moderate responsiveness (SRM > 0.5) in patients that sustained a subsequent fracture., Conclusion: Both EQ-5D-5L and SF-6D appeared to be valid utility instruments in patients with fractures attending the FLS. However, they cannot be used interchangeably given only moderate agreement was identified, and differences in utilities and ceiling effect were revealed. Comparable construct validity and responsiveness were indicated, and neither instrument was found to be clearly superior.

Published
2022
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25. Improvement of osteoporosis Care Organized by Nurses: ICON study - Protocol of a quasi-experimental study to assess the (cost)-effectiveness of combining a decision aid with motivational interviewing for improving medication persistence in patients with a recent fracture being treated at the fracture liaison service.

Author

Cornelissen D, Boonen A, Evers S, van den Bergh JP, Bours S, Wyers CE, van Kuijk S, van Oostwaard M, van der Weijden T, and Hiligsmann M

Subjects
Cost-Benefit Analysis, Decision Support Techniques, Humans, Medication Adherence, Motivational Interviewing, Nurses, Osteoporosis drug therapy, Osteoporotic Fractures drug therapy
Abstract

Background: Given the health and economic burden of fractures related to osteoporosis, suboptimal adherence to medication and the increasing importance of shared-decision making, the Improvement of osteoporosis Care Organized by Nurses (ICON) study was designed to evaluate the effectiveness, cost-effectiveness and feasibility of a multi-component adherence intervention (MCAI) for patients with an indication for treatment with anti-osteoporosis medication, following assessment at the Fracture Liaison Service after a recent fracture. The MCAI involves two consultations at the FLS. During the first consultation, a decision aid is will be used to involve patients in the decision of whether to start anti-osteoporosis medication. During the follow-up visit, the nurse inquires about, and stimulates, medication adherence using motivational interviewing techniques., Methods: A quasi-experimental trial to evaluate the (cost-) effectiveness and feasibility of an MCAI, consisting of a decision aid (DA) at the first visit, combined with nurse-led adherence support using motivational interviewing during the follow-up visit, in comparison with care as usual, in improving adherence to oral anti-osteoporosis medication for patients with a recent fracture two Dutch FLS. Medication persistence, defined as the proportion of patients who are persistent at one year assuming a refill gap < 30 days, is the primary outcome. Medication adherence, decision quality, subsequent fractures and mortality are the secondary outcomes. A lifetime cost-effectiveness analysis using a model-based economic evaluation and a process evaluation will also be conducted. A sample size of 248 patients is required to show an improvement in the primary outcome with 20%. Study follow-up is at 12 months, with measurements at baseline, after four months, and at 12 months., Discussion: We expect that the ICON-study will show that the MCAI is a (cost-)effective intervention for improving persistence with anti-osteoporosis medication and that it is feasible for implementation at the FLS., Trial Registration: This trial has been registered in the Netherlands Trial Registry, part of the Dutch Cochrane Centre (Trial NL7236 (NTR7435)). Version 1.0; 26-11-2020., (© 2021. The Author(s).)

Published
2021
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26. Management of bone health in patients with cancer: a survey of specialist nurses.

Author

Drudge-Coates L, van Muilekom E, de la Torre-Montero JC, Leonard K, van Oostwaard M, Niepel D, and Jensen BT

Subjects
Adult, Antineoplastic Agents adverse effects, Antineoplastic Agents therapeutic use, Bone Neoplasms drug therapy, Bone Resorption chemically induced, Breast Neoplasms drug therapy, Denosumab therapeutic use, Diphosphonates therapeutic use, Europe, Female, Humans, Male, Oncology Nursing, Palliative Care, Quality of Life psychology, Surveys and Questionnaires, Bone Density drug effects, Bone Density Conservation Agents therapeutic use, Bone Neoplasms secondary, Bone Resorption drug therapy, Breast Neoplasms pathology
Abstract

Background: Patients with cancer can experience bone metastases and/or cancer treatment-induced bone loss (CTIBL), and the resulting bone complications place burdens on patients and healthcare provision. Management of bone complications is becoming increasingly important as cancer survival rates improve. Advances in specialist oncology nursing practice benefit patients through better management of their bone health, which may improve quality of life and survival., Methods: An anonymised online quantitative survey asked specialist oncology nurses about factors affecting their provision of support in the management of bone metastases and CTIBL., Results: Of 283 participants, most stated that they worked in Europe, and 69.3% had at least 8 years of experience in oncology. The most common areas of specialisation were medical oncology, breast cancer and/or palliative care (20.8-50.9%). Awareness of bone loss prevention measures varied (from 34.3% for alcohol intake to 77.4% for adequate calcium intake), and awareness of hip fracture risk factors varied (from 28.6% for rheumatoid arthritis to 74.6% for age > 65 years). Approximately one-third reported a high level of confidence in managing bone metastases (39.9%) and CTIBL (33.2%). International or institution guidelines were used by approximately 50% of participants. Common barriers to better specialist care and treatment were reported to be lack of training, funding, knowledge or professional development., Conclusion: This work is the first quantitative analysis of reports from specialist oncology nurses about the management of bone metastases and CTIBL. It indicates the need for new nursing education initiatives with a focus on bone health management.

Published
2020
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27. Feasibility and effectiveness of a lifestyle intervention after complicated pregnancies to improve risk factors for future cardiometabolic disease.

Author

Berks D, Hoedjes M, Raat H, Franx A, Looman CWN, Van Oostwaard MF, Papatsonis DNM, Duvekot JJ, and Steegers EAP

Subjects
Diabetes, Gestational therapy, Feasibility Studies, Female, Fetal Growth Retardation therapy, Humans, Non-Randomized Controlled Trials as Topic, Postnatal Care methods, Pre-Eclampsia therapy, Pregnancy, Risk Factors, Cardiovascular Diseases prevention & control, Diabetes Mellitus prevention & control, Healthy Lifestyle, Postpartum Period
Abstract

Objectives: To evaluate the feasibility and effectiveness of a postpartum lifestyle intervention after pregnancies complicated by preeclampsia, fetal growth restriction (FGR) and/or gestational diabetes mellitus (GDM) to improve maternal risk factors for future cardiometabolic disease., Methods: Women following a complicated pregnancy were included six months postpartum in this specific pre-post controlled designed study. It has been conducted in one tertiary and three secondary care hospitals (intervention group) and one secondary care hospital (control group). The program consisted of a computer-tailored health education program combined with three individual counselling sessions during seven months. Primary outcome measures were the proportion of eligible women and weight change during the intervention., Results: Two hundred and six women were willing to participate. The proportion of eligible women who complied with the intervention was 23%. Major barrier was lack of time. Adjusted weight change attributed to lifestyle intervention was -1.9 kg (95%-CI -4.3 to -0.3). Further changes were BMI (-0.9 kg/m 2 (95%-CI -1.4 to -0.3)), waist-to-hip ratio (-0.04 cm/cm (95%-CI -0.06 to -0.03)), blood pressure medication use (19% (95%-CI 9% to 28%)), HOMA2-score (59 %S (95%-CI 18 to 99)) and total fat intake (-2.9 gr (95%-CI -4.6 to -1.2))., Conclusions: The results support feasibility and effectiveness of a lifestyle intervention after complicated pregnancies to improve maternal cardiometabolic risk factors. Further randomized controlled studies are needed with longer follow-up to evaluate durability. In the meantime, we suggest health care professionals to offer lifestyle interventions to women after complicated pregnancies., (Copyright © 2018 International Society for the Study of Hypertension in Pregnancy. Published by Elsevier B.V. All rights reserved.)

Published
2019
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28. Cerebrovascular, cardiovascular and renal hypertensive disease after hypertensive disorders of pregnancy.

Author

Schokker SA, Van Oostwaard MF, Melman EM, Van Kessel JP, Baharoglu MI, Roos YB, Vogt L, De Winter RJ, Mol BW, and Ganzevoort W

Subjects
Adult, Cardiovascular System physiopathology, Case-Control Studies, Female, Humans, Hypertension, Pregnancy-Induced epidemiology, Hypertension, Renal etiology, Middle Aged, Netherlands epidemiology, Pre-Eclampsia epidemiology, Pregnancy, Prevalence, Risk Factors, Stroke etiology, Hypertension, Renal epidemiology, Stroke epidemiology
Abstract

Background: Strong associations have been established in nationwide registry studies between hypertensive disorders of pregnancy (HDP) and later vascular morbidities and mortality. The aim of this case-control study is to examine the interdependent relationships of different predictive factors for vascular disease and HDP, because they are not clearly elucidated due to lack of detail in registries., Methods and Results: We assembled three different case groups of women who had cerebrovascular, cardiovascular, or hypertensive kidney disease before the age of 55. The control group consisted of age-matched women who underwent hysterectomy for benign reasons. We assessed the occurrence of HDP in previous pregnancies. The strength of the association with vascular morbidities was tested with multivariable logistic regression in comparison with classic vascular risk factors. In all case groups, previous HDP occurred more frequent than in the control group. In logistic regression analysis, previous HDP were the strongest predictor in the cerebrovascular group (OR 4.2; 95% confidence interval [CI] 1.6-11.0). In the cardiovascular group and the kidney failure group a similar association was found, however, this was not statistically significant (OR 4.4 (95% CI 0.82-4) and 2.9 (95% CI 0.61-14), respectively)., Conclusions: Previous hypertensive disorders of pregnancy are a strong predictor for later vascular morbidity. This is partially mediated through the presence of classic vascular risk factors, but our data suggest it is also an independent predictor., (Copyright © 2015 International Society for the Study of Hypertension in Pregnancy. Published by Elsevier B.V. All rights reserved.)

Published
2015
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29. Prediction of recurrence of hypertensive disorders of pregnancy between 34 and 37 weeks of gestation: a retrospective cohort study.

Author

van Oostwaard MF, Langenveld J, Bijloo R, Wong KM, Scholten I, Loix S, Hukkelhoven CW, Vergouwe Y, Papatsonis DN, Mol BW, and Ganzevoort W

Subjects
Adult, Cohort Studies, Female, Humans, Hypertension, Pregnancy-Induced diagnosis, Hypertension, Pregnancy-Induced prevention & control, Infant, Newborn, Infant, Small for Gestational Age, Logistic Models, Multivariate Analysis, Odds Ratio, Pregnancy, Retrospective Studies, Risk, Risk Factors, Secondary Prevention, Decision Support Techniques, Hypertension, Pregnancy-Induced etiology
Abstract

Objective: To assess the recurrence risk of late-preterm hypertensive disease of pregnancy, and to determine whether potential risk factors are predictive., Design: Retrospective cohort study., Setting: Three secondary and three tertiary care hospitals in the Netherlands., Population: We identified women with a hypertensive disorder in the index pregnancy and delivery at 34-37 weeks of gestation, between January 2000 and December 2002., Methods: Data were extracted from medical files and women were approached for additional information on subsequent pregnancies. An adverse outcome was defined as the recurrence of a hypertensive disorder in the next subsequent pregnancy., Main Outcome Measures: Absolute risk of recurrence and a prediction model containing demographic and clinical factors predictive for adverse outcome., Results: We identified 425 women who matched the criteria, of whom 351 could be contacted. Of these women, 189 (54%) had had a subsequent pregnancy. Hypertensive disorders recurred in 96 (51%, 95% CI 43-58%) women, of whom 17 (9%, 95% CI 5-14%) delivered again before 37 weeks of gestation. Chronic hypertension and maternal age were the strongest predictors for recurrence. Women undergoing recurrence had a nine-fold chance of developing chronic hypertension (37% versus 6%, OR 8.7, 95% CI 3.3-23)., Conclusions: Women with hypertensive disorders and late-preterm delivery have a 50% chance of recurrence, but only a 9% chance of recurrence resulting in delivery before 37 weeks of gestation. Women with chronic hypertension are prone to develop recurrence, and women with a recurrence more often developed chronic hypertension., (© 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.)

Published
2012
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