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1. 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

2. How individual participant data meta-analyses have influenced trial design, conduct, and analysis

Author: Alderson, P., Askie, L., Bennett, D., Burdett, S., Clarke, M., Dias, S., Emberson, J., Gueyffier, F., Iorio, A., Macleod, M., Mol, B.W., Moons, C., Parmar, M., Perera, R., Phillips, R., Pignon, J.P., Rees, J., Reitsma, H., Riley, R., Rovers, M., Rydzewska, L., Schmid, C., Shepperd, S., Stenning, S., Stewart, L., Tierney, J., Tudur Smith, C., Vale, C., Welge, J., White, I., Whiteley, W., Tierney, Jayne F., Pignon, Jean-Pierre, Gueffyier, Francois, Clarke, Mike, Askie, Lisa, Vale, Claire L., and Burdett, Sarah
Published: 2015
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3. Delayed Versus Early Umbilical Cord Clamping for Preterm Infants: A Systematic Review and Meta-Analysis

Author: Fogarty, M., Osborn, D.A., Askie, L., Seidler, A.L., Hunter, K., Lui, K., Simes, J., and Tarnow-Mordi, W.
Published: 2018
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4. 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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5. Transforming Obesity Prevention for CHILDren (TOPCHILD) Collaboration: Protocol for a systematic review with individual participant data meta-analysis of behavioural interventions for the prevention of early childhood obesity

Author: Hunter, K.E., Johnson, B.J., Askie, L., Golley, R.K., Baur, L.A., Marschner, I.C., Larsen, J.K., Karssen, L.T., Anzman-Frasca, S., Seidler, A.L., Hunter, K.E., Johnson, B.J., Askie, L., Golley, R.K., Baur, L.A., Marschner, I.C., Larsen, J.K., Karssen, L.T., Anzman-Frasca, S., and Seidler, A.L.
Abstract: Contains fulltext : 246375.pdf (Publisher’s version ) (Open Access), Introduction: Behavioural interventions in early life appear to show some effect in reducing childhood overweight and obesity. However, uncertainty remains regarding their overall effectiveness, and whether effectiveness differs among key subgroups. These evidence gaps have prompted an increase in very early childhood obesity prevention trials worldwide. Combining the individual participant data (IPD) from these trials will enhance statistical power to determine overall effectiveness and enable examination of individual and trial-level subgroups. We present a protocol for a systematic review with IPD meta-analysis to evaluate the effectiveness of obesity prevention interventions commencing antenatally or in the first year after birth, and to explore whether there are differential effects among key subgroups. Methods and analysis: Systematic searches of Medline, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycInfo and trial registries for all ongoing and completed randomised controlled trials evaluating behavioural interventions for the prevention of early childhood obesity have been completed up to March 2021 and will be updated annually to include additional trials. Eligible trialists will be asked to share their IPD; if unavailable, aggregate data will be used where possible. An IPD meta-analysis and a nested prospective meta-analysis will be performed using methodologies recommended by the Cochrane Collaboration. The primary outcome will be body mass index z-score at age 24±6 months using WHO Growth Standards, and effect differences will be explored among prespecified individual and trial-level subgroups. Secondary outcomes include other child weight-related measures, infant feeding, dietary intake, physical activity, sedentary behaviours, sleep, parenting measures and adverse events. Ethics and dissemination: Approved by The University of Sydney Human Research Ethics Committee (2020/2
Published: 2022

6. Transforming Obesity Prevention for CHILDren (TOPCHILD) Collaboration: protocol for a systematic review with individual participant data meta-analysis of behavioural interventions for the prevention of early childhood obesity

Author: Hunter, KE, Johnson, BJ, Askie, L, Golley, RK, Baur, LA, Marschner, IC, Taylor, RW, Wolfenden, L, Wood, CT, Mihrshahi, S, Hayes, AJ, Rissel, C, Robledo, KP, O'Connor, DA, Espinoza, D, Staub, LP, Chadwick, P, Taki, S, Barba, A, Libesman, S, Aberoumand, M, Smith, WA, Sue-See, M, Hesketh, Kylie, Thomson, JL, Bryant, M, Paul, IM, Verbestel, V, Stough, CO, Wen, LM, Larsen, JK, O'Reilly, Sharleen, Wasser, HM, Savage, JS, Ong, KK, Salvy, SJ, Messito, MJ, Gross, RS, Karssen, LT, Rasmussen, FE, Campbell, Karen, Linares, AM, Øverby, NC, Palacios, C, Joshipura, KJ, González Acero, C, Lakshman, R, Thompson, AL, Maffeis, C, Oken, E, Ghaderi, A, Campos Rivera, M, Pérez-Expósito, AB, Banna, JC, de la Haye, K, Goran, M, Røed, M, Anzman-Frasca, S, Taylor, BJ, Seidler, AL, Hunter, KE, Johnson, BJ, Askie, L, Golley, RK, Baur, LA, Marschner, IC, Taylor, RW, Wolfenden, L, Wood, CT, Mihrshahi, S, Hayes, AJ, Rissel, C, Robledo, KP, O'Connor, DA, Espinoza, D, Staub, LP, Chadwick, P, Taki, S, Barba, A, Libesman, S, Aberoumand, M, Smith, WA, Sue-See, M, Hesketh, Kylie, Thomson, JL, Bryant, M, Paul, IM, Verbestel, V, Stough, CO, Wen, LM, Larsen, JK, O'Reilly, Sharleen, Wasser, HM, Savage, JS, Ong, KK, Salvy, SJ, Messito, MJ, Gross, RS, Karssen, LT, Rasmussen, FE, Campbell, Karen, Linares, AM, Øverby, NC, Palacios, C, Joshipura, KJ, González Acero, C, Lakshman, R, Thompson, AL, Maffeis, C, Oken, E, Ghaderi, A, Campos Rivera, M, Pérez-Expósito, AB, Banna, JC, de la Haye, K, Goran, M, Røed, M, Anzman-Frasca, S, Taylor, BJ, and Seidler, AL
Published: 2022

7. Unpacking the behavioural components and delivery features of early childhood obesity prevention interventions in the TOPCHILD Collaboration: a systematic review and intervention coding protocol

Author: Johnson, BJ, Hunter, KE, Golley, RK, Chadwick, P, Barba, A, Aberoumand, M, Libesman, S, Askie, L, Taylor, RW, Robledo, KP, Mihrshahi, S, O'Connor, DA, Hayes, AJ, Wolfenden, L, Wood, CT, Baur, LA, Rissel, C, Staub, LP, Taki, S, Smith, W, Sue-See, M, Marschner, IC, Espinoza, D, Thomson, JL, Larsen, JK, Verbestel, V, Odar Stough, C, Salvy, SJ, O'Reilly, SL, Karssen, LT, Rasmussen, FE, Messito, MJ, Gross, RS, Bryant, M, Paul, IM, Wen, LM, Hesketh, Kylie, González Acero, C, Campbell, Karen, Øverby, NC, Linares, AM, Wasser, HM, Joshipura, KJ, Palacios, C, Maffeis, C, Thompson, AL, Ghaderi, A, Lakshman, R, Banna, JC, Oken, E, Campos Rivera, M, Pérez-Expósito, AB, Taylor, BJ, Savage, JS, Røed, M, Goran, M, de la Haye, K, Anzman-Frasca, S, Seidler, AL, Johnson, BJ, Hunter, KE, Golley, RK, Chadwick, P, Barba, A, Aberoumand, M, Libesman, S, Askie, L, Taylor, RW, Robledo, KP, Mihrshahi, S, O'Connor, DA, Hayes, AJ, Wolfenden, L, Wood, CT, Baur, LA, Rissel, C, Staub, LP, Taki, S, Smith, W, Sue-See, M, Marschner, IC, Espinoza, D, Thomson, JL, Larsen, JK, Verbestel, V, Odar Stough, C, Salvy, SJ, O'Reilly, SL, Karssen, LT, Rasmussen, FE, Messito, MJ, Gross, RS, Bryant, M, Paul, IM, Wen, LM, Hesketh, Kylie, González Acero, C, Campbell, Karen, Øverby, NC, Linares, AM, Wasser, HM, Joshipura, KJ, Palacios, C, Maffeis, C, Thompson, AL, Ghaderi, A, Lakshman, R, Banna, JC, Oken, E, Campos Rivera, M, Pérez-Expósito, AB, Taylor, BJ, Savage, JS, Røed, M, Goran, M, de la Haye, K, Anzman-Frasca, S, and Seidler, AL
Published: 2022

8. External validation of prognostic models predicting pre-eclampsia: individual participant data meta-analysis

Author: Snell, K, Allotey, J, Smuk, M, Hooper, R, Chan, C, Ahmed, A, Chappell, L, Von Dadelszen, P, Green, M, Kenny, L, Khalil, A, Khan, K, Mol, B, Myers, J, Poston, L, Thilaganathan, B, Staff, A, Smith, G, Ganzevoort, W, Laivuori, H, Odibo, A, Arenas Ramirez, J, Kingdom, J, Daskalakis, G, Farrar, D, Baschat, A, Seed, P, Prefumo, F, da Silva Costa, F, Groen, H, Audibert, F, Masse, J, Skrastad, R, Salvesen, K, Haavaldsen, C, Nagata, C, Rumbold, A, Heinonen, S, Askie, L, Smits, L, Vinter, C, Magnus, P, Eero, K, Villa, P, Jenum, A, Andersen, L, Norman, J, Ohkuchi, A, Eskild, A, Bhattacharya, S, Mcauliffe, F, Galindo, A, Herraiz, I, Carbillon, L, Klipstein-Grobusch, K, Yeo, S, Browne, J, Moons, K, Riley, R, Thangaratinam, S, Vergani, P, Snell K. I. E., Allotey J., Smuk M., Hooper R., Chan C., Ahmed A., Chappell L. C., Von Dadelszen P., Green M., Kenny L., Khalil A., Khan K. S., Mol B. W., Myers J., Poston L., Thilaganathan B., Staff A. C., Smith G. C. S., Ganzevoort W., Laivuori H., Odibo A. O., Arenas Ramirez J., Kingdom J., Daskalakis G., Farrar D., Baschat A. A., Seed P. T., Prefumo F., da Silva Costa F., Groen H., Audibert F., Masse J., Skrastad R. B., Salvesen K. A., Haavaldsen C., Nagata C., Rumbold A. R., Heinonen S., Askie L. M., Smits L. J. M., Vinter C. A., Magnus P., Eero K., Villa P. M., Jenum A. K., Andersen L. B., Norman J. E., Ohkuchi A., Eskild A., Bhattacharya S., McAuliffe F. M., Galindo A., Herraiz I., Carbillon L., Klipstein-Grobusch K., Yeo S. A., Browne J. L., Moons K. G. M., Riley R. D., Thangaratinam S., Vergani P., Snell, K, Allotey, J, Smuk, M, Hooper, R, Chan, C, Ahmed, A, Chappell, L, Von Dadelszen, P, Green, M, Kenny, L, Khalil, A, Khan, K, Mol, B, Myers, J, Poston, L, Thilaganathan, B, Staff, A, Smith, G, Ganzevoort, W, Laivuori, H, Odibo, A, Arenas Ramirez, J, Kingdom, J, Daskalakis, G, Farrar, D, Baschat, A, Seed, P, Prefumo, F, da Silva Costa, F, Groen, H, Audibert, F, Masse, J, Skrastad, R, Salvesen, K, Haavaldsen, C, Nagata, C, Rumbold, A, Heinonen, S, Askie, L, Smits, L, Vinter, C, Magnus, P, Eero, K, Villa, P, Jenum, A, Andersen, L, Norman, J, Ohkuchi, A, Eskild, A, Bhattacharya, S, Mcauliffe, F, Galindo, A, Herraiz, I, Carbillon, L, Klipstein-Grobusch, K, Yeo, S, Browne, J, Moons, K, Riley, R, Thangaratinam, S, Vergani, P, Snell K. I. E., Allotey J., Smuk M., Hooper R., Chan C., Ahmed A., Chappell L. C., Von Dadelszen P., Green M., Kenny L., Khalil A., Khan K. S., Mol B. W., Myers J., Poston L., Thilaganathan B., Staff A. C., Smith G. C. S., Ganzevoort W., Laivuori H., Odibo A. O., Arenas Ramirez J., Kingdom J., Daskalakis G., Farrar D., Baschat A. A., Seed P. T., Prefumo F., da Silva Costa F., Groen H., Audibert F., Masse J., Skrastad R. B., Salvesen K. A., Haavaldsen C., Nagata C., Rumbold A. R., Heinonen S., Askie L. M., Smits L. J. M., Vinter C. A., Magnus P., Eero K., Villa P. M., Jenum A. K., Andersen L. B., Norman J. E., Ohkuchi A., Eskild A., Bhattacharya S., McAuliffe F. M., Galindo A., Herraiz I., Carbillon L., Klipstein-Grobusch K., Yeo S. A., Browne J. L., Moons K. G. M., Riley R. D., Thangaratinam S., and Vergani P.
Abstract: BACKGROUND: Pre-eclampsia is a leading cause of maternal and perinatal mortality and morbidity. Early identification of women at risk during pregnancy is required to plan management. Although there are many published prediction models for pre-eclampsia, few have been validated in external data. Our objective was to externally validate published prediction models for pre-eclampsia using individual participant data (IPD) from UK studies, to evaluate whether any of the models can accurately predict the condition when used within the UK healthcare setting. METHODS: IPD from 11 UK cohort studies (217,415 pregnant women) within the International Prediction of Pregnancy Complications (IPPIC) pre-eclampsia network contributed to external validation of published prediction models, identified by systematic review. Cohorts that measured all predictor variables in at least one of the identified models and reported pre-eclampsia as an outcome were included for validation. We reported the model predictive performance as discrimination (C-statistic), calibration (calibration plots, calibration slope, calibration-in-the-large), and net benefit. Performance measures were estimated separately in each available study and then, where possible, combined across studies in a random-effects meta-analysis. RESULTS: Of 131 published models, 67 provided the full model equation and 24 could be validated in 11 UK cohorts. Most of the models showed modest discrimination with summary C-statistics between 0.6 and 0.7. The calibration of the predicted compared to observed risk was generally poor for most models with observed calibration slopes less than 1, indicating that predictions were generally too extreme, although confidence intervals were wide. There was large between-study heterogeneity in each model's calibration-in-the-large, suggesting poor calibration of the predicted overall risk across populations. In a subset of models, the net benefit of using the models to inform clinical decisions
Published: 2020

9. Reporting of Cochrane systematic review protocols with network meta-analyses - a scoping review.

Author: Wang R., Dwan K., Showell M.G., van Wely M., Mol B.W., Askie L., Seidler A.L., Wang R., Dwan K., Showell M.G., van Wely M., Mol B.W., Askie L., and Seidler A.L.
Abstract: Publishing systematic review protocols is a fundamental part of systematic reviews to ensure transparency and reproducibility. In this scoping review, we aimed to evaluate reporting of Cochrane systematic review protocols with network meta-analyses (NMA). We searched all Cochrane NMA protocols published in 2018 and 2019, and assessed the characteristics and reporting of methodologies relevant to NMA. We reported frequencies for each reporting item. Forty-five protocols were assessed, including two for overviews and 43 for intervention reviews. Thirty-three (73%) were labelled as NMA protocols in the title. Forty-two (95%) justified the need of an NMA and 40 (89%) used appropriate search strategies to identify potential eligible studies. About half (24, 53%) considered the transitivity assumption when reporting inclusion criteria and 35 (78%) specified potential effect modifiers. Forty-three (96%) reported statistical software for NMA, 25 (56%) reported NMA model choice, 32 (71%) reported framework choice and 32 (71%) reported assumption about heterogeneity variances. Protocols varied in whether they reported methods for relative ranking (35, 78%), statistical inconsistency (40, 89%), reporting bias (44, 98%) and sources of heterogeneity (39, 87%). In conclusion, Cochrane NMA protocols reported multiple NMA-specific items well, but could be further improved, especially regarding transitivity assumptions. Our recommendations for NMA protocol reporting based on this scoping review could assist authors, reviewers and editors to improve NMA protocols. This article is protected by copyright. All rights reserved.
Published: 2021

10. Quantifying the advantages of conducting a prospective meta-analysis (PMA): a case study of early childhood obesity prevention

Author: Seidler, A. L., Hunter, K. E., Espinoza, D., Mihrshahi, S., Askie, L. M., Martin, A., Daniels, L. A., Taylor, R., Wen, L. M., Campbell, Karen, Hesketh, Kylie, Rissel, C., Taylor, B., Magarey, A., Baur, L. A., Seidler, A. L., Hunter, K. E., Espinoza, D., Mihrshahi, S., Askie, L. M., Martin, A., Daniels, L. A., Taylor, R., Wen, L. M., Campbell, Karen, Hesketh, Kylie, Rissel, C., Taylor, B., Magarey, A., and Baur, L. A.
Abstract: Background: For prospective meta-analyses (PMAs), eligible studies are identified, and the PMA hypotheses, selection criteria, and analysis methods are pre-specified before the results of any of the studies are known. This reduces publication bias and selective outcome reporting and provides a unique opportunity for outcome standardisation/harmonisation. We conducted a world-first PMA of four trials investigating interventions to prevent early childhood obesity. The aims of this study were to quantitatively analyse the effects of prospective planning on variations across trials, outcome harmonisation, and the power to detect intervention effects, and to derive recommendations for future PMA. Methods: We examined intervention design, participant characteristics, and outcomes collected across the four trials included in the EPOCH PMA using their registration records, protocol publications, and variable lists. The outcomes that trials planned to collect prior to inclusion in the PMA were compared to the outcomes that trials collected after PMA inclusion. We analysed the proportion of matching outcome definitions across trials, the number of outcomes per trial, and how collaboration increased the statistical power to detect intervention effects. Results: The included trials varied in intervention design and participants, this improved external validity and the ability to perform subgroup analyses for the meta-analysis. While individual trials had limited power to detect the main intervention effect (BMI z-score), synthesising data substantially increased statistical power. Prospective planning led to an increase in the number of collected outcome categories (e.g. weight, child’s diet, sleep), and greater outcome harmonisation. Prior to PMA inclusion, only 18% of outcome categories were included in all trials. After PMA inclusion, this increased to 91% of outcome categories. However, while trials mostly collected the same out
Published: 2021

11. Impact of a cancer clinical trials web site on discussions about trial participation: a cluster randomized trial

Author: Dear, R. F., Barratt, A. L., Askie, L. M., Butow, P. N., McGeechan, K., Crossing, S., Currow, D. C., and Tattersall, M. H. N.
Published: 2012
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12. GENERATING EVIDENCE OF REDUCED RATES OF OVERWEIGHT/ OBESITY IN CHILDREN: VALUE ADDING TO FOUR ESTABLISHED AUSTRALASIAN EARLY INTERVENTION TRIALS: 974 accepted poster

Author: Askie, L., Baur, L., Campbell, K., Daniels, L., Taylor, B., Wen, L. M., Hesketh, K., Magarey, A., Taylor, R., Martin, A., Mihrshahi, S., Rissel, C., Simes, J., and Voysey, M.
Published: 2012

13. The AEDUCATE Collaboration. Comprehensive antenatal education birth preparation programmes to reduce the rates of caesarean section in nulliparous women. Protocol for an individual participant data prospective meta-analysis.

Author: Seidler A.L., Arnott L., Sutcliffe K., Hunter K.E., Askie L., Levett K.M., Lord S.J., Dahlen H.G., Smith C.A., Girosi F., Downe S., Finlayson K.W., Fleet J., Steen M., Davey M.-A., Newnham E., Werner A., Seidler A.L., Arnott L., Sutcliffe K., Hunter K.E., Askie L., Levett K.M., Lord S.J., Dahlen H.G., Smith C.A., Girosi F., Downe S., Finlayson K.W., Fleet J., Steen M., Davey M.-A., Newnham E., and Werner A.
Abstract: INTRODUCTION: Rates of medical interventions in normal labour and birth are increasing. This prospective meta-analysis (PMA) proposes to assess whether the addition of a comprehensive multicomponent birth preparation programme reduces caesarean section (CS) in nulliparous women compared with standard hospital care. Additionally, do participant characteristics, intervention components or hospital characteristics modify the effectiveness of the programme? METHODS AND ANALYSIS: Population: women with singleton vertex pregnancies, no planned caesarean section (CS) or epidural. Intervention(s): in addition to hospital-based standard care, a comprehensive antenatal education programme that includes multiple components for birth preparation, addressing the three objectives: preparing women and their birth partner/support person for childbirth through education on physiological/hormonal birth (knowledge and understanding); building women's confidence through psychological preparation (positive mindset) and support their ability to birth without pain relief using evidence-based tools (tools and techniques). The intervention could occur in a hospital-based or community setting.Comparator: standard care alone in hospital-based maternity units. OUTCOME(S): Primary: CS.Secondary: epidural analgesia, mode of birth, perineal trauma, postpartum haemorrhage, newborn resuscitation, psychosocial well-being.Subgroup analysis: parity, model of care, maternal risk status, maternal education, maternal socio-economic status, intervention components. STUDY DESIGN: An individual participant data (IPD) prospective meta-analysis (PMA) of randomised controlled trials, including cluster design. Each trial is conducted independently but share core protocol elements to contribute data to the PMA. Participating trials are deemed eligible for the PMA if their results are not yet known outside their Data Monitoring Committees. ETHICS AND DISSEMINATION: Participants in the individual trials will conse
Published: 2020

14. Understanding, comparing and learning from the four EPOCH early childhood obesity prevention interventions: A multi-methods study

Author: Seidler, AL, Hunter, KE, Johnson, BJ, Ekambareshwar, M, Taki, S, Mauch, CE, Mihrshahi, S, Askie, L, Campbell, Karen, Daniels, L, Taylor, RW, Wen, LM, Byrne, R, Lawrence, J, Perlstein, Robyn, Wardle, K, Golley, RK, Seidler, AL, Hunter, KE, Johnson, BJ, Ekambareshwar, M, Taki, S, Mauch, CE, Mihrshahi, S, Askie, L, Campbell, Karen, Daniels, L, Taylor, RW, Wen, LM, Byrne, R, Lawrence, J, Perlstein, Robyn, Wardle, K, and Golley, RK
Published: 2020

15. Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP): study protocol

Author: Seidler, AL, Duley, L, Katheria, AC, De Paco Matallana, C, Dempsey, E, Rabe, H, Kattwinkel, J, Mercer, J, Josephsen, J, Fairchild, K, Andersson, O, Hosono, S, Sundaram, V, Datta, V, El-Naggar, W, Tarnow-Mordi, W, Debray, T, Hooper, SB, Kluckow, M, Polglase, G, Davis, PG, Montgomery, A, Hunter, KE, Barba, A, Simes, J, Askie, L, Seidler, AL, Duley, L, Katheria, AC, De Paco Matallana, C, Dempsey, E, Rabe, H, Kattwinkel, J, Mercer, J, Josephsen, J, Fairchild, K, Andersson, O, Hosono, S, Sundaram, V, Datta, V, El-Naggar, W, Tarnow-Mordi, W, Debray, T, Hooper, SB, Kluckow, M, Polglase, G, Davis, PG, Montgomery, A, Hunter, KE, Barba, A, Simes, J, and Askie, L
Abstract: INTRODUCTION: Timing of cord clamping and other cord management strategies may improve outcomes at preterm birth. However, it is unclear whether benefits apply to all preterm subgroups. Previous and current trials compare various policies, including time-based or physiology-based deferred cord clamping, and cord milking. Individual participant data (IPD) enable exploration of different strategies within subgroups. Network meta-analysis (NMA) enables comparison and ranking of all available interventions using a combination of direct and indirect comparisons. OBJECTIVES: (1) To evaluate the effectiveness of cord management strategies for preterm infants on neonatal mortality and morbidity overall and for different participant characteristics using IPD meta-analysis. (2) To evaluate and rank the effect of different cord management strategies for preterm births on mortality and other key outcomes using NMA. METHODS AND ANALYSIS: Systematic searches of Medline, Embase, clinical trial registries, and other sources for all ongoing and completed randomised controlled trials comparing cord management strategies at preterm birth (before 37 weeks' gestation) have been completed up to 13 February 2019, but will be updated regularly to include additional trials. IPD will be sought for all trials; aggregate summary data will be included where IPD are unavailable. First, deferred clamping and cord milking will be compared with immediate clamping in pairwise IPD meta-analyses. The primary outcome will be death prior to hospital discharge. Effect differences will be explored for prespecified participant subgroups. Second, all identified cord management strategies will be compared and ranked in an IPD NMA for the primary outcome and the key secondary outcomes. Treatment effect differences by participant characteristics will be identified. Inconsistency and heterogeneity will be explored. ETHICS AND DISSEMINATION: Ethics approval for this project has been granted by the University of
Published: 2020

16. Appropriate levels of oxygen saturation for preterm infants

Author: Askie, L
Published: 2004

17. A randomized trial of enteral feeding volumes in infants born before 30 weeks’ gestation

Author: Kuschel, C A, Evans, N, Askie, L, Bredemeyer, S, Nash, J, and Polverino, J
Published: 2000

18. Attitudes of neonatal clinicians towards resuscitation of the extremely premature infant: An exploratory survey

Author: OEI, J, ASKIE, L M, TOBIANSKY, R, and LUI, K
Published: 2000

19. Late pregnancy sleep disruption - pathological or physiological?

Author: Cronin, R., primary, Li, M., additional, Thompson, J., additional, Gordon, A., additional, Greenow, C. Raynes, additional, Heazell, A., additional, Stacey, T., additional, Culling, V., additional, Anderson, N., additional, Wilson, J., additional, O'Brien, L., additional, Mitchell, E., additional, Askie, L., additional, and McCowan, L., additional
Published: 2019
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20. Effects of repeat prenatal corticosteroids given to women at risk of preterm birth: An individual participant data meta-analysis

Author: Myers, JE, Crowther, CA, Middleton, PF, Voysey, M, Askie, L, Zhang, S, Martlow, TK, Aghajafari, F, Asztalos, E, Brocklehurst, P, Dutta, S, Garite, TJ, Guinn, DA, Hallman, M, Hardy, P, Lee, M-J, Maurel, K, Mazumder, P, McEvoy, C, Murphy, KE, Peltoniemi, OM, Thom, EA, Wapner, RJ, Doyle, LW, Myers, JE, Crowther, CA, Middleton, PF, Voysey, M, Askie, L, Zhang, S, Martlow, TK, Aghajafari, F, Asztalos, E, Brocklehurst, P, Dutta, S, Garite, TJ, Guinn, DA, Hallman, M, Hardy, P, Lee, M-J, Maurel, K, Mazumder, P, McEvoy, C, Murphy, KE, Peltoniemi, OM, Thom, EA, Wapner, RJ, and Doyle, LW
Abstract: BACKGROUND: Infants born preterm compared with infants born at term are at an increased risk of dying and of serious morbidities in early life, and those who survive have higher rates of neurological impairments. It remains unclear whether exposure to repeat courses of prenatal corticosteroids can reduce these risks. This individual participant data (IPD) meta-analysis (MA) assessed whether repeat prenatal corticosteroid treatment given to women at ongoing risk of preterm birth in order to benefit their infants is modified by participant or treatment factors. METHODS AND FINDINGS: Trials were eligible for inclusion if they randomised women considered at risk of preterm birth who had already received an initial, single course of prenatal corticosteroid seven or more days previously and in which corticosteroids were compared with either placebo or no placebo. The primary outcomes for the infants were serious outcome, use of respiratory support, and birth weight z-scores; for the children, they were death or any neurosensory disability; and for the women, maternal sepsis. Studies were identified using the Cochrane Pregnancy and Childbirth search strategy. Date of last search was 20 January 2015. IPD were sought from investigators with eligible trials. Risk of bias was assessed using criteria from the Cochrane Collaboration. IPD were analysed using a one-stage approach. Eleven trials, conducted between 2002 and 2010, were identified as eligible, with five trials being from the United States, two from Canada, and one each from Australia and New Zealand, Finland, India, and the United Kingdom. All 11 trials were included, with 4,857 women and 5,915 infants contributing data. The mean gestational age at trial entry for the trials was between 27.4 weeks and 30.2 weeks. There was no significant difference in the proportion of infants with a serious outcome (relative risk [RR] 0.92, 95% confidence interval [CI] 0.82 to 1.04, 5,893 infants, 11 trials, p = 0.33 for heterogeneit
Published: 2019

21. Periodontal and chronic kidney disease association: A systematic review and meta-analysis

Author: Kapellas, K, Singh, A, Bertotti, M, Nascimento, GG, Jamieson, LM, Hughes, J, Sajiv, C, Fernandes, D, Pawar, B, Harris, D, Hoy, W, Cass, A, Maple-Brown, L, Brown, A, Skilton, M, Askie, L, Bartold, PM, Arrow, P, Kapellas, K, Singh, A, Bertotti, M, Nascimento, GG, Jamieson, LM, Hughes, J, Sajiv, C, Fernandes, D, Pawar, B, Harris, D, Hoy, W, Cass, A, Maple-Brown, L, Brown, A, Skilton, M, Askie, L, Bartold, PM, and Arrow, P
Abstract: AIM: Chronic kidney disease (CKD) and kidney failure is increasing globally and evidence from observational studies suggest periodontal disease may contribute to kidney functional decline. METHODS: Electronic searches of the PubMed, EMBASE, Web of Science, Scopus and Cochrane Library databases were conducted for the purposes of conducting a systematic review. Hand searching of reference lists was also performed. Meta-analysis of observational studies involving periodontal disease and chronic kidney disease in adults was performed. RESULTS: A total of 17 studies was selected from an initial 4055 abstracts. Pooled estimates indicated the odds of having CKD were 60% higher among patients with periodontitis: pooled OR 1.60 (95% CI 1.44-1.79, I2 35.2%, P = 0.11) compared to those without. Conversely, a similar magnitude but non-significant higher odds of having periodontal disease was found among people with CKD 1.69 (95% CI: 0.84, 3.40, I2 = 89.8%, P < 0.00) versus non-CKD. Meta-regression revealed study quality based on the Newcastle-Ottawa Scale and statistical adjustment for potential confounders explained almost 35% of the heterogeneity in the studies investigating the association between CKD and periodontitis. CONCLUSIONS: Moderate evidence for a positive association between periodontitis and CKD exists. Evidence for the opposite direction is extremely weak based on significant heterogeneity between studies.
Published: 2019

22. Effects of repeat prenatal corticosteroids given to women at risk of preterm birth:an individual participant data meta-analysis

Author: Crowther, C. A. (Caroline A.), Middleton, P. F. (Philippa F.), Voysey, M. (Merryn), Askie, L. (Lisa), Zhang, S. (Sasha), Martlow, T. K. (Tanya K.), Aghajafari, F. (Fariba), Asztalos, E. V. (Elizabeth V.), Brocklehurst, P. (Peter), Dutta, S. (Sourabh), Garite, T. J. (Thomas J.), Guinn, D. A. (Debra A.), Hallman, M. (Mikko), Hardy, P. (Pollyanna), Lee, M.-J. (Men-Jean), Maurel, K. (Kimberley), Mazumder, P. (Premasish), McEvoy, C. (Cindy), Murphy, K. E. (Kellie E.), Peltoniemi, O. M. (Outi M.), Thom, E. A. (Elizabeth A.), Wapner, R. J. (Ronald J.), Doyle, L. W. (Lex W.), Crowther, C. A. (Caroline A.), Middleton, P. F. (Philippa F.), Voysey, M. (Merryn), Askie, L. (Lisa), Zhang, S. (Sasha), Martlow, T. K. (Tanya K.), Aghajafari, F. (Fariba), Asztalos, E. V. (Elizabeth V.), Brocklehurst, P. (Peter), Dutta, S. (Sourabh), Garite, T. J. (Thomas J.), Guinn, D. A. (Debra A.), Hallman, M. (Mikko), Hardy, P. (Pollyanna), Lee, M.-J. (Men-Jean), Maurel, K. (Kimberley), Mazumder, P. (Premasish), McEvoy, C. (Cindy), Murphy, K. E. (Kellie E.), Peltoniemi, O. M. (Outi M.), Thom, E. A. (Elizabeth A.), Wapner, R. J. (Ronald J.), and Doyle, L. W. (Lex W.)
Abstract: Background: Infants born preterm compared with infants born at term are at an increased risk of dying and of serious morbidities in early life, and those who survive have higher rates of neurological impairments. It remains unclear whether exposure to repeat courses of prenatal corticosteroids can reduce these risks. This individual participant data (IPD) meta-analysis (MA) assessed whether repeat prenatal corticosteroid treatment given to women at ongoing risk of preterm birth in order to benefit their infants is modified by participant or treatment factors. Methods and findings: Trials were eligible for inclusion if they randomised women considered at risk of preterm birth who had already received an initial, single course of prenatal corticosteroid seven or more days previously and in which corticosteroids were compared with either placebo or no placebo. The primary outcomes for the infants were serious outcome, use of respiratory support, and birth weight z-scores; for the children, they were death or any neurosensory disability; and for the women, maternal sepsis. Studies were identified using the Cochrane Pregnancy and Childbirth search strategy. Date of last search was 20 January 2015. IPD were sought from investigators with eligible trials. Risk of bias was assessed using criteria from the Cochrane Collaboration. IPD were analysed using a one-stage approach. Eleven trials, conducted between 2002 and 2010, were identified as eligible, with five trials being from the United States, two from Canada, and one each from Australia and New Zealand, Finland, India, and the United Kingdom. All 11 trials were included, with 4,857 women and 5,915 infants contributing data. The mean gestational age at trial entry for the trials was between 27.4 weeks and 30.2 weeks. There was no significant difference in the proportion of infants with a serious outcome (relative risk [RR] 0.92, 95% confidence interval [CI] 0.82 to 1.04, 5,893 infants, 11 trials, p = 0.33 for het
Published: 2019

23. Protocol for the Lactoferrin Infant Feeding Trial (LIFT) : A randomised trial of adding lactoferrin to the feeds of very-low birthweight babies prior to hospital discharge

Author: Martin, A., Ghadge, A., Manzoni, P., Lui, K., Brown, R., Tarnow-Mordi, W., Lu, K., Simes, J., Hague, W., Osborn, D., Deshpande, G., Kochar, A., Lewis, T., Watkins, A., Pritchard, M., Schofield, D., Mohamed, A. L., Soll, R., Darlow, B., Isaacs, D., Wilkinson, D., Wood, A., Mckenzie, A., Despande, G., Verry, H., Wright, I., Askie, L., Cruz, M., Berry, N., Mcguire, W., Broom, M., Osoborn, D., Reid, S., Sinn, J., Kwan, P., Tracy, M., Hua, C., Travadi, J., Black, R., Tobiansky, R., Darcy, D., Tai, S. N. H., Michalowski, J., Bhaskaracharya, A., Yeomans, E., Elsayed, K., Collins, C., Noble, E., Koorts, P., Lack, G., Mckeown, L., Liley, H., Nie, W., Morris, S., Cornthwaite, K., Goodchild, L., Austin, N., Graham, T., Patel, H., Sanchez, D., Mckinlay, C., Modi, N., Marschner, I., Stenson, B., and Espinoza, D.
Subjects: Male, Pediatrics, Enterocolitis, infant, lactoferrin, necrotizing, premature, sepsis, Clinical Protocols, Female, Hospital Mortality, Humans, Infant, Infant Mortality, Infant, Newborn, Intensive Care Units, Neonatal, Lactoferrin, Infant Food, Infant, Very Low Birth Weight, 0302 clinical medicine, Neonatal, Protocol, 030212 general & internal medicine, 2. Zero hunger, Enterocolitis, necrotizing, biology, Retinopathy of prematurity, General Medicine, 3. Good health, Intensive Care Units, Necrotizing enterocolitis, Gestation, medicine.symptom, medicine.medical_specialty, infant, premature, Breast milk, Sepsis, 03 medical and health sciences, 030225 pediatrics, medicine, business.industry, Very Low Birth Weight, Paediatrics, Newborn, medicine.disease, Infant mortality, biology.protein, business
Abstract: IntroductionVery-low birthweight (VLBW, Methods and analysisThis trial tests whether adding bovine lactoferrin (bLF) to feeds in VLBW infants improves (1) survival to hospital discharge free from brain injury, late-onset sepsis, NEC and treated retinopathy of prematurity (primary composite end point); (2) each component of the primary composite end point and (3) time to reach full enteral feeds, number of blood transfusions, chronic lung disease and length of hospital stay. It includes a cost-effectiveness analysis of bLF in improving survival free from major morbidity, and evaluates the effect of bLF on survival and developmental outcomes at 24 to 36 months corrected gestational age.This is a multicentre, two-arm, randomised trial comparing the treatment group receiving bLF added to breast milk or formula milk daily (up to 250 mg/kg/day bLF) versus the control group receiving no bLF supplementation. The intervention is administered until 34 completed weeks corrected gestation or for 2 weeks, whichever is longer, or until discharge home, if earlier. The target sample size of 1500 participants yields 85% power, at the two-sided 5% level significance, to detect a difference in proportions meeting the primary outcome assuming the true probability is 74% in controls and 80.5% in the bLF group.Ethics and disseminationThis protocol was approved by Northern Sydney Local Human Research Ethics Committee in January 2017 (Version 2.0, Reference 1003-118M) and other relevant ethics committees. The findings of the trial will be disseminated through peer-reviewed journals and conference presentations.Trial registration numberACTRN12611000247976; Pre-results.
Published: 2018

24. Oxygen saturation and outcomes in preterm infants

Author: Group, Boost II United Kingdom Collaborative, Group, Boost II Australia Collaborative, Group, Boost II New Zealand Collaborative, Stenson, B, Tarnow-Mordi, W, Darlow, B, Simes, J, Juszczak, E, Askie, L, Battin, M, Bowler, U, Broadbent, R, Cairns, P, Davis, P, Deshpande, S, Donoghoe, M, Doyle, L, Fleck, B, Ghadge, A, Hague, W, Halliday, H, Hewson, M, King, A, Kirby, A, Marlow, N, Meyer, M, Morley, C, Simmer, K, Tin, W, Wardle, S, and Brocklehurst, P
Subjects: Pediatrics, medicine.medical_specialty, medicine.diagnostic_test, business.industry, Retinopathy of prematurity, General Medicine, medicine.disease, Interim analysis, law.invention, Pulse oximetry, Clinical research, Randomized controlled trial, law, Necrotizing enterocolitis, medicine, Gestation, business, Oxygen saturation (medicine)
Abstract: BACKGROUND: The clinically appropriate range for oxygen saturation in preterm infants is unknown. Previous studies have shown that infants had reduced rates of retinopathy of prematurity when lower targets of oxygen saturation were used. METHODS: In three international randomized, controlled trials, we evaluated the effects of targeting an oxygen saturation of 85 to 89%, as compared with a range of 91 to 95%, on disability-free survival at 2 years in infants born before 28 weeks' gestation. Halfway through the trials, the oximeter-calibration algorithm was revised. Recruitment was stopped early when an interim analysis showed an increased rate of death at 36 weeks in the group with a lower oxygen saturation. We analyzed pooled data from patients and now report hospital-discharge outcomes. RESULTS: A total of 2448 infants were recruited. Among the 1187 infants whose treatment used the revised oximeter-calibration algorithm, the rate of death was significantly higher in the lower-target group than in the higher-target group (23.1% vs. 15.9%; relative risk in the lower-target group, 1.45; 95% confidence interval [CI], 1.15 to 1.84; P=0.002). There was heterogeneity for mortality between the original algorithm and the revised algorithm (P=0.006) but not for other outcomes. In all 2448 infants, those in the lower-target group for oxygen saturation had a reduced rate of retinopathy of prematurity (10.6% vs. 13.5%; relative risk, 0.79; 95% CI, 0.63 to 1.00; P=0.045) and an increased rate of necrotizing enterocolitis (10.4% vs. 8.0%; relative risk, 1.31; 95% CI, 1.02 to 1.68; P=0.04). There were no significant between-group differences in rates of other outcomes or adverse events. CONCLUSIONS: Targeting an oxygen saturation below 90% with the use of current oximeters in extremely preterm infants was associated with an increased risk of death. (Funded by the Australian National Health and Medical Research Council and others; BOOST II Current Controlled Trials number, ISRCTN00842661. opens in new tab, and Australian New Zealand Clinical Trials Registry numbers, ACTRN12605000055606. opens in new tab and ACTRN12605000253606. opens in new tab.)
Published: 2016
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25. Assessing the neuroprotective benefits for babies of antenatal magnesium sulphate: An individual participant data meta-analysis

Author: Myers, JE, Crowther, CA, Middleton, PF, Voysey, M, Askie, L, Duley, L, Pryde, PG, Marret, S, Doyle, LW, Myers, JE, Crowther, CA, Middleton, PF, Voysey, M, Askie, L, Duley, L, Pryde, PG, Marret, S, and Doyle, LW
Abstract: BACKGROUND: Babies born preterm are at an increased risk of dying in the first weeks of life, and those who survive have a higher rate of cerebral palsy (CP) compared with babies born at term. The aim of this individual participant data (IPD) meta-analysis (MA) was to assess the effects of antenatal magnesium sulphate, compared with no magnesium treatment, given to women at risk of preterm birth on important maternal and fetal outcomes, including survival free of CP, and whether effects differed by participant or treatment characteristics such as the reason the woman was at risk of preterm birth, why treatment was given, the gestational age at which magnesium sulphate treatment was received, or the dose and timing of the administration of magnesium sulphate. METHODS AND FINDINGS: Trials in which women considered at risk of preterm birth (<37 weeks' gestation) were randomised to magnesium sulphate or control treatment and where neurologic outcomes for the baby were reported were eligible for inclusion. The primary outcomes were infant death or CP and severe maternal outcome potentially related to treatment. Studies were identified based on the Cochrane Pregnancy and Childbirth search strategy using the terms [antenatal or prenatal] and [magnesium] and [preterm or premature or neuroprotection or 'cerebral palsy']. The date of the last search was 28 February 2017. IPD were sought from investigators with eligible trials. Risk of bias was assessed using criteria from the Cochrane Collaboration. For each prespecified outcome, IPD were analysed using a 1-stage approach. All 5 trials identified were included, with 5,493 women and 6,131 babies. Overall, there was no clear effect of magnesium sulphate treatment compared with no treatment on the primary infant composite outcome of death or CP (relative risk [RR] 0.94, 95% confidence interval (CI) 0.85 to 1.05, 6,131 babies, 5 trials, p = 0.07 for heterogeneity of treatment effect across trials). In the prespecified sensitivity
Published: 2017

26. How individual participant data meta-analyses have influenced trial design, conduct, and analysis

Author: Tierney, J.F., Pignon, J.P., Gueffyier, F., Clarke, M., Askie, L., Vale, C.L., Burdett, S., and Rovers, M.M.
Subjects: Urological cancers Radboud Institute for Health Sciences [Radboudumc 15], bacterial infections and mycoses
Abstract: Contains fulltext : 152302.pdf (Publisher’s version ) (Open Access) OBJECTIVES: To demonstrate how individual participant data (IPD) meta-analyses have impacted directly on the design and conduct of trials and highlight other advantages IPD might offer. STUDY DESIGN AND SETTING: Potential examples of the impact of IPD meta-analyses on trials were identified at an international workshop, attended by individuals with experience in the conduct of IPD meta-analyses and knowledge of trials in their respective clinical areas. Experts in the field who did not attend were asked to provide any further examples. We then examined relevant trial protocols, publications, and Web sites to verify the impacts of the IPD meta-analyses. A subgroup of workshop attendees sought further examples and identified other aspects of trial design and conduct that may inform IPD meta-analyses. RESULTS: We identified 52 examples of IPD meta-analyses thought to have had a direct impact on the design or conduct of trials. After screening relevant trial protocols and publications, we identified 28 instances where IPD meta-analyses had clearly impacted on trials. They have influenced the selection of comparators and participants, sample size calculations, analysis and interpretation of subsequent trials, and the conduct and analysis of ongoing trials, sometimes in ways that would not possible with systematic reviews of aggregate data. We identified additional potential ways that IPD meta-analyses could be used to influence trials. CONCLUSIONS: IPD meta-analysis could be better used to inform the design, conduct, analysis, and interpretation of trials.
Published: 2015

27. A core outcome set for neonatal abstinence syndrome: Study protocol for a systematic review, parent interviews and a Delphi survey

Author: Kelly, L.E. (Lauren E.), Jansson, L.M. (Lauren M.), Moulsdale, W. (Wendy), Pereira, J. (Jodi), Simpson, S. (Sarah), Guttman, A. (Astrid), Allegaert, K. (Karel), Askie, L. (Lisa), Roukema, H. (Henry), Lacaze, T. (Thierry), Davis, J.M. (Jonathan M.), Finnegan, L. (Loretta), Williamson, P. (Paula), Offringa, M. (Martin), Kelly, L.E. (Lauren E.), Jansson, L.M. (Lauren M.), Moulsdale, W. (Wendy), Pereira, J. (Jodi), Simpson, S. (Sarah), Guttman, A. (Astrid), Allegaert, K. (Karel), Askie, L. (Lisa), Roukema, H. (Henry), Lacaze, T. (Thierry), Davis, J.M. (Jonathan M.), Finnegan, L. (Loretta), Williamson, P. (Paula), and Offringa, M. (Martin)
Abstract: Background: The prevalence of neonatal abstinence syndrome (NAS) is increasing globally resulting in an increased incidence of adverse neonatal outcomes and health system costs. Evidence regarding the effectiveness of NAS prevention and management strategies is very weak and further research initiatives are critically needed to support meta-analysis and clinical practice guidelines. In NAS research, the choice of outcomes and the use of valid, responsive and feasible measurement instruments are crucial. There is currently no consensus and evidence-based core outcome set (COS) for NAS. Methods/design: The development of the NAS-COS will include five stages led by an international Multidisciplinary Steering Committee: (1) qualitative interviews with parents/families and a systematic review (SR) to identify items for inclusion in a COS. The SR will also identify participants for the Delphi survey, (2) a three-round Delphi survey to gain expert opinion on the importance of health outcomes influencing NAS management decisions, (3), a consensus meeting to finalize the items and definitions with experts and COS users, (4) feasibility and pilot testing, development of the COS and explanatory document and (5) implementation planning. Discussion: Since standardized outcome measurement and reporting will improve NAS clinical research consistency, efficacy and impact, this COS will reflect the minimum set of health outcomes which should be measured in trials evaluating interventions for preventing or treating NAS.
Published: 2016
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28. Clinicians in 25 countries prefer to use lower levels of oxygen to resuscitate preterm infants at birth

Author: Oei, JL, Ghadge, A, Coates, E, Wright, IM, Saugstad, OD, Vento, M, Buonocore, G, Nagashima, T, Suzuki, K, Hosono, S, Davis, PG, Craven, P, Askie, L, Dawson, J, Garg, S, Keech, A, Rabi, Y, Smyth, J, Sinha, S, Stenson, B, Lui, K, Hunter, CL, Mordi, WT, Oei, JL, Ghadge, A, Coates, E, Wright, IM, Saugstad, OD, Vento, M, Buonocore, G, Nagashima, T, Suzuki, K, Hosono, S, Davis, PG, Craven, P, Askie, L, Dawson, J, Garg, S, Keech, A, Rabi, Y, Smyth, J, Sinha, S, Stenson, B, Lui, K, Hunter, CL, and Mordi, WT
Abstract: AIM: This study determined current international clinical practice and opinions regarding initial fractional inspired oxygen (FiO2 ) and pulse oximetry (SpO2 ) targets for delivery room resuscitation of preterm infants of less than 29 weeks of gestation. METHODS: An online survey was disseminated to neonatal clinicians via established professional clinical networks using a web-based survey programme between March 9 and June 30, 2015. RESULTS: Of the 630 responses from 25 countries, 60% were from neonatologists. The majority (77%) would target SpO2 between the 10th to 50th percentiles values for full-term infants. The median starting FiO2 was 0.3, with Japan using the highest (0.4) and the UK using the lowest (0.21). New Zealand targeted the highest SpO2 percentiles (median 50%). Most respondents agreed or did not disagree that a trial was required that compared the higher FiO2 of 0.6 (83%), targeting the 50th SpO2 percentile (60%), and the lower FiO2 of 0.21 (80%), targeting the 10th SpO2 percentile (78%). Most (65%) would join this trial. Many considered that evidence was lacking and further research was needed. CONCLUSION: Clinicians currently favour lower SpO2 targets for preterm resuscitation, despite acknowledging the lack of evidence for benefit or harm, and 65% would join a clinical trial.
Published: 2016

29. OC08.06: Antiplatelet therapy before or after 16 weeks' gestation for preventing pre‐eclampsia: an individual participant data meta‐analysis

Author: Meher, S., primary, Duley, L., additional, Hunter, K., additional, and Askie, L., additional
Published: 2016
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30. Standard 4: Determining Adequate Sample Sizes

Author: van der Tweel, I, Askie, L, Vandermeer, B, Ellenberg, S, Fernandes, R, Saloojee, H, Bassler, D, Altman, D, Offringa, M, van der Lee, J, Grp, S, and General Paediatrics
Subjects: Pediatrics, medicine.medical_specialty, business.industry, MEDLINE, Environmental air flow, Reproducibility of Results, Sample (statistics), Statistical power, Outcome (probability), law.invention, Superiority Trial, Randomized controlled trial, Sample size determination, law, Sample Size, Pediatrics, Perinatology and Child Health, Practice Guidelines as Topic, Medicine, Humans, Medical physics, business, Randomized Controlled Trials as Topic
Abstract: * Abbreviations: CINV — : chemotherapy-induced nausea and vomiting RCT — : randomized controlled trial RSV — : respiratory syncytial virus There are many challenges to be faced when conducting randomized controlled trials (RCTs) in pediatric research. One important challenge is the determination of an appropriate sample size. Recruiting more children than necessary risks unnecessary overexposure of children to an inferior treatment, whereas underestimating the sample required will lead to inconclusive or unreliable results. Both options pose important ethical dilemmas for the pediatric researcher. Reviews have concluded that sample size calculations are frequently based on inaccurate assumptions regarding the key pieces of information needed.1,2 For example, a recent “failed” pediatric RCT highlighted the commonly encountered problem of underestimating the SD of a continuous primary outcome variable.3 This leads to underestimation of the necessary sample size, inadequate statistical power, and, consequently, an unanswered study question. Similarly, an incorrect estimation of the frequency with which a dichotomous outcome, or event, occurs in the control group of a trial (known as the control or baseline event rate) will also lead to incorrect sample size estimation. This standards article uses a series of scenarios to assist pediatric researchers in not only determining an adequate trial sample size but also how to proceed when this sample size may be difficult to achieve. Recommendations for practice are summarized in Table 1. View this table: TABLE 1 Recommendations for Practice Methods to calculate adequate sample sizes are described for superiority, noninferiority, and cluster-randomized trials with various types of primary outcome variables, including continuous, dichotomous, or time-to-event data.4–10 In this article, we focus primarily on superiority trial designs with continuous or dichotomous outcomes. Information on noninferiority or equivalence designs, as well as on cluster-randomized designs, can be found in the literature.9,10 RCTs generally have many outcomes of interest, but the number of patients required (and the main statistical analysis) should be based on … Address correspondence to Martin Offringa, MD, PhD, Senior Scientist and Program Head, Child Health Evaluative Sciences, Research Institute, The Hospital for Sick Children, 555 University Ave, Toronto, Ontario, Canada M5G 1X8. E-mail: martin.offringa{at}sickkids.ca
Published: 2012

31. Antenatal magnesium individual participant data international collaboration: assessing the benefits for babies using the best level of evidence (AMICABLE)

Author: Crowther, C, Middleton, P, Askie, L, Doyle, L, Bubner, T, and Voysey, M
Subjects: medicine.medical_specialty, Medicine (miscellaneous), Infant, Premature, Diseases, Prenatal care, Magnesium Sulfate, Nursing, Pregnancy, Risk Factors, Infant Mortality, Protocol, medicine, Humans, Fetal Death, Randomized Controlled Trials as Topic, Evidence-Based Medicine, Fetal death, Obstetrics, business.industry, Cerebral Palsy, Individual participant data, Infant, Newborn, Pregnancy Outcome, Magnesium sulphate, Prenatal Care, Preterm birth, Evidence-based medicine, Infant newborn, Infant mortality, Meta-analysis, Neuroprotective Agents, Premature Birth, Individual patient data, Female, business
Abstract: BackgroundThe primary aim of this study is to assess, using individual participant data (IPD) meta-analysis, the effects of administration of antenatal magnesium sulphate given to women at risk of preterm birth on important clinical outcomes for their child such as death and neurosensory disability. The secondary aim is to determine whether treatment effects differ depending on important pre-specified participant and treatment characteristics, such as reasons at risk of preterm birth, gestational age, or type, dose and mode of administration of magnesium sulphate.MethodsDesignThe Antenatal Magnesium Individual Participant Data (IPD) International Collaboration: assessing the benefits for babies using the best level of evidence (AMICABLE) Group will perform an IPD meta-analysis to answer these important clinical questions.Setting/TimelineThe AMICABLE Group was formed in 2009 with data collection commencing late 2010.Inclusion CriteriaFive trials involving a total 6,145 babies are eligible for inclusion in the IPD meta-analysis.Primary study outcomesFor the infants/children: Death or cerebral palsy. For the women: Any severe maternal outcome potentially related to treatment (death, respiratory arrest or cardiac arrest).DiscussionResults are expected to be publicly available in 2012.
Published: 2012
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32. NeOProM: Neonatal Oxygenation Prospective Meta-analysis Collaboration study protocol

Author: Askie, L. M., Brocklehurst, P., Darlow, B. A., Finer, N., Schmidt, B., Tarnow-Mordi, W., and NeOProM Collaborative Group, The
Subjects: LOW-BIRTH-WEIGHT, PREVENTING RETROLENTAL FIBROPLASIA, 28 WEEKS GESTATION, PRETERM INFANTS, SUPPLEMENTAL OXYGEN, SEVERE RETINOPATHY, RANDOMIZED-TRIALS, PULSE OXIMETRY, CEREBRAL-PALSY, FOLLOW-UP
Abstract: Background: The appropriate level of oxygenation for extremely preterm neonates (< 28 weeks' gestation) to maximise the greatest chance of survival, without incurring significant morbidity, remains unknown. Infants exposed to lower levels of oxygen (targeting oxygen saturations of < 90%) in the first weeks of life are at increased risk of death, cerebral palsy, patent ductus arteriosus, pulmonary vascular resistance and apnoea, whilst those maintained in higher levels of oxygen (targeting oxygen saturations of > 90%) have been reported to have greater rates of morbidity including retinopathy of prematurity and chronic lung disease. In order to answer this clinical dilemma reliably, large scale trial evidence is needed.Methods/Design: To detect a small but important 4% increase in death or severe disability in survivors, over 5000 neonates would need to be recruited. As extreme prematurity affects 1% of births, such a project undertaken by one trial group would be prohibitively lengthy and expensive. Hence, the Neonatal Oxygenation Prospective Meta-analysis (NeOProM) Collaboration has been formed. A prospective meta-analysis (PMA) is one where studies are identified, evaluated, and determined to be eligible before the results of any included studies are known or published, thereby avoiding some of the potential biases inherent in standard, retrospective meta-analyses. This methodology provides the same strengths as a single large-scale multicentre randomised study whilst allowing greater pragmatic flexibility. The NeOProM Collaboration protocol (NCT01124331) has been agreed prior to the results of individual trials being available. This includes pre-specifying the hypotheses, inclusion criteria and outcome measures to be used. Each trial will first publish their respective results as they become available and the combined meta-analytic results, using individual patient data, will be published when all trials are complete. The primary outcome to be assessed is a composite outcome of death or major disability at 18 months - 2 years corrected age. Secondary outcomes include several measures of neonatal morbidity. The size of the combined dataset will allow the effect of the interventions to be explored more reliably with respect to pre-specified patient- and intervention-level characteristics.Discussion: Results should be available by 2014.
Published: 2011

33. Periodontal disease and chronic kidney disease among Aboriginal adults; An RCT

Author: Jamieson, L., Skilton, M., Maple-Brown, L., Kapellas, K., Askie, L., Hughes, J., Arrow, P., Cherian, S., Fernandes, D., Pawar, B., Brown, A., Boffa, John, Hoy, W., Harris, D., Mueller, N., Cass, A., Jamieson, L., Skilton, M., Maple-Brown, L., Kapellas, K., Askie, L., Hughes, J., Arrow, P., Cherian, S., Fernandes, D., Pawar, B., Brown, A., Boffa, John, Hoy, W., Harris, D., Mueller, N., and Cass, A.
Abstract: Â© 2015 Jamieson et al. Background: This study will assess measures of vascular health and inflammation in Aboriginal Australian adults with chronic kidney disease (CKD), and determine if intensive periodontal intervention improves cardiovascular health, progression of renal disease and periodontal health over a 24-month follow-up. Methods: The study will be a randomised controlled trial. All participants will receive the periodontal intervention benefits, with the delayed intervention group receiving periodontal treatment 24 months following baseline. Inclusion criteria include being an Aboriginal Australian, having CKD (a. on dialysis; b. eGFR levels of < 60 mls/min/1.73 m 2 (CKD Stages 3 to 5); c. ACR =30 mg/mmol irrespective of eGFR (CKD Stages 1 and 2); d. diabetes plus albuminuria (ACR = 3 mg/mmol) irrespective of eGFR), having moderate or severe periodontal disease, having at least 12 teeth, and living in Central Australia for the 2-year study duration. The intervention involves intensive removal of dental plaque biofilms by scaling, root-planing and removal of teeth that cannot be saved. The intervention will occur in three visits; baseline, 3-month and 6-month follow-up. The primary outcome will be changes in carotid intima-media thickness (cIMT). Secondary outcomes will include progression of CKD or death as a consequence of CKD/cardiovascular disease. Progression of CKD will be defined by time to the development of the first of: (1) new development of macroalbuminuria; (2) 30 % loss of baseline eGFR; (3) progression to end stage kidney disease defined by eGFR < 15 mLs/min/1.73 m 2 ; (4) progression to end stage kidney disease defined by commencement of renal replacement therapy. A sample size of 472 is necessary to detect a difference in cIMT of 0.026 mm (SD 0.09) at the significance criterion of 0.05 and a power of 0.80. Allowing for 20 % attrition, 592 participants are necessary at baseline, rounded to 600 for convenience. Discussion: This will be
Published: 2015

34. The performance of risk prediction models for pre-eclampsia using routinely collected maternal characteristics and comparison with models that include specialised tests and with clinical guideline decision rules: a systematic review.

Author: Al‐Rubaie, ZTA, Askie, LM, Ray, JG, Hudson, HM, Lord, SJ, Al-Rubaie, Zta, Askie, L M, Ray, J G, Hudson, H M, and Lord, S J
Subjects: ECLAMPSIA, LABOR (Obstetrics), DELIVERY (Obstetrics), CHILDBIRTH, CESAREAN section
Abstract: Background: Risk prediction models may be valuable to identify women at risk of pre-eclampsia to guide aspirin prophylaxis in early pregnancy.Objective: To assess the performance of 'simple' risk models for pre-eclampsia that use routinely collected maternal characteristics; compare with 'specialised' models that include specialised tests; and to guideline recommended decision rules.Search Strategy: MEDLINE, Embase and PubMed were searched to June 2014.Selection Criteria: We included studies that developed or validated pre-eclampsia risk models using maternal characteristics with or without specialised tests and reported model performance.Data Collection and Analysis: We extracted data on study characteristics; model predictors, validation and performance including area under the curve (AUC), sensitivity and specificity.Main Results: We identified 29 studies that developed 70 models including 22 simple models. Studies included 151-9149 women with a pre-eclampsia prevalence of 1.2-9.5%. No single predictor was included in all models. Four simple models were externally validated, with a model using parity, pre-eclampsia history, race, chronic hypertension and conception method to predict early-onset pre-eclampsia achieving the highest AUC (0.76, 95% CI 0.74-0.77). Nine studies comparing simple versus specialized models in the same population reported AUC favouring specialised models. A simple model achieved fewer false positives than a guideline recommended risk factor list, but sensitivity to classify risk for aspirin prophylaxis was not assessed.Conclusion: Validated simple pre-eclampsia risk models demonstrate good risk discrimination that can be improved with specialised tests. Further research is needed to determine their clinical value to guide aspirin prophylaxis compared with decision rules.Tweetable Abstract: Pre-eclampsia risk models using maternal factors show good risk discrimination to guide aspirin prophylaxis. [ABSTRACT FROM AUTHOR]
Published: 2016
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35. Duration of chemotherapy for advanced non-small cell lung cancer: An updated systematic review and meta-analysis

Author: Soon, Y., primary, Stockler, M. R., additional, Boyer, M., additional, and Askie, L., additional
Published: 2008
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36. Appropriate levels of oxygen saturation for preterm infants

Author: Askie, L, primary
Published: 2007
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37. The Use of Oxygen in Neonatal Medicine: Half a Century of Uncertainty

Author: Askie, L. M., primary and Tin, W., additional
Published: 2003
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38. Evidence review on older people's views and experiences of falls prevention strategies.

Author: McInnes E and Askie L
Published: 2004
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39. Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-Analysis Collaboration.

Author: Askie, L. M., Darlow, B. A., Finer, N., Schmidt, B., Stenson, B., Tarnow-Mordi, W., Davis, P. G., Carlo, W. A., Brocklehurst, P., Davies, L. C., Das, A., Rich, W., Gantz, M. G., Roberts, R. S., Whyte, R. K., Costantini, L., Poets, C., Asztalos, E., Battin, M., and Halliday, H. L.
Published: 2019
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40. Transforming Obesity Prevention for CHILDren (TOPCHILD) Collaboration : protocol for a systematic review with individual participant data meta-analysis of behavioural interventions for the prevention of early childhood obesity

Author: Hunter, K, Johnson, B., Askie, L, Golley, R, Baur, L, Marschner, I, Taylor, R., Wolfenden, L, Wood, C., Mihrshahi, S, Hayes, A, Rissel, C, Robledo, K, O'Connor, D, Espinoza, D, Staub, L, Chadwick, Paul R, Taki, S, Barba, A, Libesman, S, Aberoumond, M, Smith, W, Sue-See, M, Hesketh, K, Thomson, J, Bryant, Maria, Paul, I, Verbestel, V, Stough, C, Wen, L, Larsen, J, O'Reilly, S, Wasser, H, Savage, J, Ong, Ken K., Salvy, S, Messito, M, Gross, R, Karssen, L, Rasmussen, F, Campbell, K, Linares, A, Overby, N, Palacios, C, Joshipura, K, Acero, C, Lakshman, R, Thompson, A, Maffeis, C, Oken, E, Ghaderi, A, Campos Rivera, M, Perez-Exposito, A, Banna, J, de la Haye, K, Goran, M, Anzman-Frasca, S, and Seidler, A

41. How individual participant data meta-analyses have influenced trial design, conduct, and analysis

Author: Jayne Tierney, Jp, Pignon, Gueffyier F, Clarke M, Askie L, Cl, Vale, Burdett S, and Ipd, Cochrane Meta-Analysis Methods Group

42. Abstracts of the 26th World Congress on Ultrasound in Obstetrics and Gynecology, Rome, Italy, 24-28 September 2016.

Author: Meher, S., Duley, L., Hunter, K., and Askie, L.
Subjects: PLATELET aggregation inhibitors, PREECLAMPSIA prevention, SECOND trimester of pregnancy
Abstract: An abstract of the article "Antiplatelet therapy before or after 16 weeks' gestation for preventing pre-eclampsia: an individual participant data meta-analysis," by S. Meher and colleagues is presented.
Published: 2016
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43. Delayed versus Immediate Cord Clamping in Preterm Infants.

Author: Tarnow-Mordi, W., Morris, J., Kirby, A., Robledo, K., Askie, L., Brown, R., Evans, N., Finlayson, S., Fogarty, M., Gebski, V., Ghadge, A., Hague, W., Isaacs, D., Jeffery, M., Keech, A., Kluckow, M., Popat, H., Sebastian, L., Aagaard, K., and Belfort, M.
Subjects: *PREMATURE infants, *UMBILICAL cord clamping, *GESTATIONAL age, *PREMATURE infant diseases, *UMBILICAL cord, *DELIVERY (Obstetrics), *DEVELOPMENT of premature infants, *CHILDBIRTH, *PREMATURE infants -- Hospital care, *APGAR score, *BLOOD circulation, *COMPARATIVE studies, *HEMATOCRIT, *INFANT mortality, *RESEARCH methodology, *MEDICAL cooperation, *RESEARCH, *RESEARCH funding, *TIME, *EVALUATION research, *DISEASE incidence, PREMATURE infant death
Abstract: Background: The preferred timing of umbilical-cord clamping in preterm infants is unclear.Methods: We randomly assigned fetuses from women who were expected to deliver before 30 weeks of gestation to either immediate clamping of the umbilical cord (≤10 seconds after delivery) or delayed clamping (≥60 seconds after delivery). The primary composite outcome was death or major morbidity (defined as severe brain injury on postnatal ultrasonography, severe retinopathy of prematurity, necrotizing enterocolitis, or late-onset sepsis) by 36 weeks of postmenstrual age. Analyses were performed on an intention-to-treat basis, accounting for multiple births.Results: Of 1634 fetuses that underwent randomization, 1566 were born alive before 30 weeks of gestation; of these, 782 were assigned to immediate cord clamping and 784 to delayed cord clamping. The median time between delivery and cord clamping was 5 seconds and 60 seconds in the respective groups. Complete data on the primary outcome were available for 1497 infants (95.6%). There was no significant difference in the incidence of the primary outcome between infants assigned to delayed clamping (37.0%) and those assigned to immediate clamping (37.2%) (relative risk, 1.00; 95% confidence interval, 0.88 to 1.13; P=0.96). The mortality was 6.4% in the delayed-clamping group and 9.0% in the immediate-clamping group (P=0.03 in unadjusted analyses; P=0.39 after post hoc adjustment for multiple secondary outcomes). There were no significant differences between the two groups in the incidences of chronic lung disease or other major morbidities.Conclusions: Among preterm infants, delayed cord clamping did not result in a lower incidence of the combined outcome of death or major morbidity at 36 weeks of gestation than immediate cord clamping. (Funded by the Australian National Health and Medical Research Council [NHMRC] and the NHMRC Clinical Trials Centre; APTS Australian and New Zealand Clinical Trials Registry number, ACTRN12610000633088 .). [ABSTRACT FROM AUTHOR]
Published: 2017
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44. External validation of prognostic models predicting pre-eclampsia: individual participant data meta-analysis

Author: Gordon C. S. Smith, Diane Farrar, François Audibert, Hannele Laivuori, Wessel Ganzevoort, Alberto Galindo, Khalid S. Khan, Luc J.M. Smits, Javier A Ramírez, Kerstin Klipstein-Grobusch, Anne Eskild, Federico Prefumo, Jacques Massé, Christina Anne Vinter, Lionel Carbillon, SeonAe Yeo, Per Magnus, Ignacio Herraiz, Asma Khalil, Anthony Odibo, Claire L Chan, Ragnhild Bergene Skråstad, Richard Hooper, Louise Bjørkholt Andersen, Kjell Å. Salvesen, Henk Groen, Anne Karen Jenum, Karel G. M. Moons, Jane E. Norman, Richard D Riley, Kym I E Snell, Camilla Haavaldsen, Joyce L. Browne, B. Thilaganathan, Peter von Dadelszen, Pia M. Villa, Asif Ahmed, Ben W.J. Mol, Lucy C Chappell, Paul T. Seed, John Kingdom, Marcus Green, Fionnuala M. McAuliffe, Louise C. Kenny, Seppo Heinonen, Lucilla Poston, Anne Cathrine Staff, Jenny Myers, Chie Nagata, Shakila Thangaratinam, Sohinee Bhattacharya, Ahmet A. Baschat, Lisa M. Askie, Melanie Smuk, John Allotey, Kajantie Eero, Akihide Ohkuchi, Fabricio da Silva Costa, Alice R. Rumbold, George Daskalakis, HUS Gynecology and Obstetrics, Genomics of Neurological and Neuropsychiatric Disorders, Institute for Molecular Medicine Finland, Pregnancy and Genes, Department of Medical and Clinical Genetics, Department of Obstetrics and Gynecology, HUS Children and Adolescents, Lastentautien yksikkö, Clinicum, Children's Hospital, Snell, K, Allotey, J, Smuk, M, Hooper, R, Chan, C, Ahmed, A, Chappell, L, Von Dadelszen, P, Green, M, Kenny, L, Khalil, A, Khan, K, Mol, B, Myers, J, Poston, L, Thilaganathan, B, Staff, A, Smith, G, Ganzevoort, W, Laivuori, H, Odibo, A, Arenas Ramirez, J, Kingdom, J, Daskalakis, G, Farrar, D, Baschat, A, Seed, P, Prefumo, F, da Silva Costa, F, Groen, H, Audibert, F, Masse, J, Skrastad, R, Salvesen, K, Haavaldsen, C, Nagata, C, Rumbold, A, Heinonen, S, Askie, L, Smits, L, Vinter, C, Magnus, P, Eero, K, Villa, P, Jenum, A, Andersen, L, Norman, J, Ohkuchi, A, Eskild, A, Bhattacharya, S, Mcauliffe, F, Galindo, A, Herraiz, I, Carbillon, L, Klipstein-Grobusch, K, Yeo, S, Browne, J, Moons, K, Riley, R, Thangaratinam, S, Vergani, P, Smith, Gordon [0000-0003-2124-0997], Apollo - University of Cambridge Repository, RS: CAPHRI - R5 - Optimising Patient Care, Epidemiologie, Value, Affordability and Sustainability (VALUE), Reproductive Origins of Adult Health and Disease (ROAHD), Tampere University, Department of Gynaecology and Obstetrics, Clinical Medicine, APH - Quality of Care, ARD - Amsterdam Reproduction and Development, Obstetrics and Gynaecology, and APH - Digital Health
Subjects: Research design, Calibration (statistics), External validation, Individual participant data, Pre-eclampsia, Prediction model, lcsh:Medicine, Overfitting, PLACENTAL PROTEIN 13, Risk Assessment, 03 medical and health sciences, MULTIPLE IMPUTATION, 0302 clinical medicine, 3123 Gynaecology and paediatrics, Pregnancy, Statistics, Medicine, Humans, 030212 general & internal medicine, 030219 obstetrics & reproductive medicine, RISK PREDICTION, business.industry, UTERINE ARTERY DOPPLER, lcsh:R, OBESE PREGNANT-WOMEN, NULLIPAROUS WOMEN, DIAGNOSIS TRIPOD, Reproducibility of Results, General Medicine, Prognosis, R1, Confidence interval, 3. Good health, Pregnancy Complications, 1ST-TRIMESTER PREDICTION, HYPERTENSIVE DISORDERS, Research Design, Meta-analysis, Female, MATERNAL CHARACTERISTICS, Risk assessment, business, Predictive modelling, AVALIAÇÃO DE RISCO, Cohort study, Research Article
Abstract: Background Pre-eclampsia is a leading cause of maternal and perinatal mortality and morbidity. Early identification of women at risk during pregnancy is required to plan management. Although there are many published prediction models for pre-eclampsia, few have been validated in external data. Our objective was to externally validate published prediction models for pre-eclampsia using individual participant data (IPD) from UK studies, to evaluate whether any of the models can accurately predict the condition when used within the UK healthcare setting. Methods IPD from 11 UK cohort studies (217,415 pregnant women) within the International Prediction of Pregnancy Complications (IPPIC) pre-eclampsia network contributed to external validation of published prediction models, identified by systematic review. Cohorts that measured all predictor variables in at least one of the identified models and reported pre-eclampsia as an outcome were included for validation. We reported the model predictive performance as discrimination (C-statistic), calibration (calibration plots, calibration slope, calibration-in-the-large), and net benefit. Performance measures were estimated separately in each available study and then, where possible, combined across studies in a random-effects meta-analysis. Results Of 131 published models, 67 provided the full model equation and 24 could be validated in 11 UK cohorts. Most of the models showed modest discrimination with summary C-statistics between 0.6 and 0.7. The calibration of the predicted compared to observed risk was generally poor for most models with observed calibration slopes less than 1, indicating that predictions were generally too extreme, although confidence intervals were wide. There was large between-study heterogeneity in each model’s calibration-in-the-large, suggesting poor calibration of the predicted overall risk across populations. In a subset of models, the net benefit of using the models to inform clinical decisions appeared small and limited to probability thresholds between 5 and 7%. Conclusions The evaluated models had modest predictive performance, with key limitations such as poor calibration (likely due to overfitting in the original development datasets), substantial heterogeneity, and small net benefit across settings. The evidence to support the use of these prediction models for pre-eclampsia in clinical decision-making is limited. Any models that we could not validate should be examined in terms of their predictive performance, net benefit, and heterogeneity across multiple UK settings before consideration for use in practice. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Published: 2020
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45. Oxygen-saturation targets in extremely preterm infants.

Author: Ellsbury DL, Klein JM, Askie L, and Henderson-Smart D
Published: 2003

46. Implications of living evidence syntheses in health policy.

Author: Chakraborty S, Kuchenmüller T, Lavis J, El-Jardali F, Mahlanza-Langer L, Green S, Reveiz L, Carter V, McFarlane E, Pace C, Askie L, Glen F, and Turner T
Subjects: Humans, Evidence-Based Medicine, Health Policy
Published: 2024
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47. A continuous improvement agenda for WHO's normative and standard-setting functions.

Author: Askie L, Bartolomeos K, Farrar J, and Sheikh M
Subjects: Humans, Global Health, World Health Organization
Published: 2024
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48. Early magnesium discontinuation postpartum and eclampsia risk: A systematic review and meta-analysis.

Author: Quist-Nelson J, de Ruigh A, Lemoine ER, Pajkrt E, Mol B, Vigil-De Gracia P, Ludmir J, Askie L, and Berghella V
Subjects: Humans, Female, Pregnancy, Drug Administration Schedule, Magnesium administration & dosage, Pre-Eclampsia prevention & control, Pre-Eclampsia drug therapy, Randomized Controlled Trials as Topic, Eclampsia prevention & control, Magnesium Sulfate administration & dosage, Postpartum Period
Abstract: Introduction: The optimal duration of magnesium administration postpartum for prevention of eclampsia has not yet been established. Our objective was to investigate the effect of early discontinuation of postpartum magnesium on the rates of postpartum eclampsia compared to continuation for 24-hours postpartum., Material and Methods: Searches were performed using keywords related to "preeclampsia" and "magnesium sulfate" from inception of database until August 2023. Randomized controlled trials of women with preeclampsia were included if they received magnesium prior to delivery and were randomized to early discontinuation versus 24-hours of magnesium postpartum. The primary outcome was the rate of postpartum eclampsia., Results: Nine RCTs with 2183 women were included with five different magnesium administration time frames. In total, seven patients with postpartum eclampsia were reported in three studies. Eclampsia rates were not different between the two groups (5/1088 (0.5 %) after early discontinuation, versus 2/1095 (0.2 %) in the 24-hour group; RR 2.25, 95 % CI 0.5-9.9, I 2 = 0 %, 8 studies, 2183 participants). A number needed to treat was calculated; 374 women would need to receive 24-hours of magnesium postpartum to prevent one episode of postpartum eclampsia. The early discontinuation group had a significant decrease in time to ambulation (-9.1 h, 95 % CI -14.7 - (-3.6), I 2 = 98 %, 3 studies, 1509 participants) and breastfeeding (-8.4 h, 95 % CI -12.0 - (-4.8), I 2 = 98 %, 2 studies, 1397 participants)., Conclusions: Early magnesium discontinuation postpartum, usually ≤6 h or none at all, did not significantly increase the rate of postpartum eclampsia, however this study is likely underpowered to demonstrate a difference. The number needed to treat is similar to the number needed to treat for antepartum preeclampsia without severe features, for which magnesium is not recommended. The largest proportion of women did not receive magnesium postpartum after receiving at least 8 h of magnesium intrapartum (e.g., loading and maintenance dose). Thus, it is reasonable to consider not using magnesium postpartum, particularly if a woman has received similar adequate dose prior to delivery., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Ben Willem Mol is supported by a NHMRC Practitioner Fellowship (GNT1082548). Dr. Ben Willem Mol reports consultancy for ObsEva, Merck Merck KGaA and Guerbet. Dr Jack Ludmir and Dr Paulino Vigil-de Gracia were both authors on included randomized trials. The other authors did not report any potential conflicts of interest., (Copyright © 2024 International Society for the Study of Hypertension in Pregnancy. Published by Elsevier B.V. All rights reserved.)
Published: 2024
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49. Integrate evidence certainty in ranking interventions - Authors' reply.

Author: Seidler AL, Libesman S, Riley RD, Askie L, and Dias S
Subjects: Humans, Evidence-Based Medicine standards
Published: 2024
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50. Eating disorders in weight-related therapy (EDIT): Protocol for a systematic review with individual participant data meta-analysis of eating disorder risk in behavioural weight management.

Author: Jebeile H, Lister NB, Libesman S, Hunter KE, McMaster CM, Johnson BJ, Baur LA, Paxton SJ, Garnett SP, Ahern AL, Wilfley DE, Maguire S, Sainsbury A, Steinbeck K, Askie L, Braet C, Hill AJ, Nicholls D, Jones RA, Dammery G, Grunseit AM, Cooper K, Kyle TK, Heeren FA, Quigley F, Barnes RD, Bean MK, Beaulieu K, Bonham M, Boutelle KN, Branco BHM, Calugi S, Cardel MI, Carpenter K, Cheng HL, Dalle Grave R, Danielsen YS, Demarzo M, Dordevic A, Eichen DM, Goldschmidt AB, Hilbert A, Houben K, Lofrano do Prado M, Martin CK, McTiernan A, Mensinger JL, Pacanowski C, do Prado WL, Ramalho SM, Raynor HA, Rieger E, Robinson E, Salvo V, Sherwood NE, Simpson SA, Skjakodegard HF, Smith E, Partridge S, Tanofsky-Kraff M, Taylor RW, Van Eyck A, Varady KA, Vidmar AP, Whitelock V, Yanovski J, and Seidler AL
Subjects: Adult, Adolescent, Humans, Obesity, Behavior Therapy, Systematic Reviews as Topic, Meta-Analysis as Topic, Overweight complications, Overweight therapy, Feeding and Eating Disorders therapy
Abstract: The Eating Disorders In weight-related Therapy (EDIT) Collaboration brings together data from randomised controlled trials of behavioural weight management interventions to identify individual participant risk factors and intervention strategies that contribute to eating disorder risk. We present a protocol for a systematic review and individual participant data (IPD) meta-analysis which aims to identify participants at risk of developing eating disorders, or related symptoms, during or after weight management interventions conducted in adolescents or adults with overweight or obesity. We systematically searched four databases up to March 2022 and clinical trials registries to May 2022 to identify randomised controlled trials of weight management interventions conducted in adolescents or adults with overweight or obesity that measured eating disorder risk at pre- and post-intervention or follow-up. Authors from eligible trials have been invited to share their deidentified IPD. Two IPD meta-analyses will be conducted. The first IPD meta-analysis aims to examine participant level factors associated with a change in eating disorder scores during and following a weight management intervention. To do this we will examine baseline variables that predict change in eating disorder risk within intervention arms. The second IPD meta-analysis aims to assess whether there are participant level factors that predict whether participation in an intervention is more or less likely than no intervention to lead to a change in eating disorder risk. To do this, we will examine if there are differences in predictors of eating disorder risk between intervention and no-treatment control arms. The primary outcome will be a standardised mean difference in global eating disorder score from baseline to immediately post-intervention and at 6- and 12- months follow-up. Identifying participant level risk factors predicting eating disorder risk will inform screening and monitoring protocols to allow early identification and intervention for those at risk., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: AS owns 50% of the shares in Zuman International, which receives royalties for books AS has written and payments for presentations. AS additionally reports receiving presentation fees and travel reimbursements from Eli Lilly and Co, the Pharmacy Guild of Australia, Novo Nordisk, the Dietitians Association of Australia, Shoalhaven Family Medical Centres, the Pharmaceutical Society of Australia, and Metagenics, and serving on the Nestlé Health Science Optifast VLCD advisory board from 2016 to 2018. ALA is Principal Investigator on two publicly funded trials where the intervention is provided by WW (formerly Weight Watchers) at no cost. KS has received in kind support as meals from ‘Lite and Easy’ for a clinical trial of weight stigma in young women in the last 5 years. ER has previously received research funding from Unilever and the American Beverage Association for unrelated work. JAY reports unrelated grant funds to NICHD supporting his research from Soleno Therapeutics, Rhythm Pharmaceuticals, and Hikma Pharmaceuticals. HFS has previously received a salary from Novo Nordisk unrelated to the present work. YSD has previously received a salary from Novo Nordisk unrelated to the present work. HAR has received funding from the National Institutes of Health in the area of adult and pediatric weight management. HAR is a committee member for the evidence-based practice guidelines for pediatric weight management for the American Psychological Association and for the Evidence Analysis Library for the Academy of Nutrition and Dietetics for the topic of adult weight management and the prevention of type 2 diabetes. MIC is an employee and shareholder at WW International, Inc. TKK has received professional fees from Novo Nordisk, Nutrisystem, Gelesis and Johnson & Johnson. CKM has received research grants and research agreements from Commission on Dietetic Registration, Academy of Nutrition and Dietetics, Ohio State University (InFACT), Novartis, University of Michigan’s Michigan Institute for Clinical and Health Research, Elizabeth Blackwell Institute for Health Research, Egg Board, PCORI, Department of Defense, Access Business Group International LLC, IDEA Public Schools, Louisiana LIFT Fund, WW, Pack Health, American Society for Nutrition, RAND Corporation, Richard King Mellon Foundation (RKMF), The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Evidation Health, Leona M. and Harry B. Helmsley Charitable Trust, State of Louisiana- Federal American Rescue Plan (ARP), United States Department of Agriculture (USDA), National Institute for Health Research (NIHR), National Science Foundation (NSF), Lilly, National Institutes of Health (NIH). CKM has served on advisory boards for EHE Health, Wondr Health, and the Nutrition Obesity Research Center at the University of Alabama Birmingham and consulted to Kitchry, Metagenics, WW, Florida Hospital, Gila Therapeutics, Zafgen, OpenFit/MXCXM Health Inc. CKM developed intellectual property (IP) to quantify dietary adherence and his institution has licensed this IP, resulting in receiving royalties via the institution from the licensing fees. CKM is part of US and European patent applications for a weight loss approach called the Body weight Management and activity tracking system and also occasionally gives lectures and talks where he is provided with an honorarium, including talks to the Obesity Action Coalition and Indiana University Bloomington. Finally, CKM serves as a developer and facilitator for continuing education events sponsored by the Commission on Dietetic Registration, and is a Planning Committee Member for the Bray Course. The opinions and assertions expressed herein are those of the authors and are not to be construed as reflecting the views of the Public Health Service, the Department of Health and Human Services, USUHS, or the U.S. Department of Defense., (Copyright: © 2023 Jebeile et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
Published: 2023
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