Incorporating Baseline Outcome Data in Individual Participant Data Meta-Analysis of Non-randomized Studies
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Background: In non-randomized studies (NRSs) where a continuous outcome variable (e.g., depressive symptoms) is assessed at baseline and follow-up, it is common to observe imbalance of the baseline values between the treatment/exposure group and control group. This may bias the study and consequently a meta-analysis (MA) estimate. These estimates may differ across statistical methods used to deal with this issue. Analysis of individual participant data (IPD) allows standardization of methods across studies. We aimed to identify methods used in published IPD-MAs of NRSs for continuous outcomes, and to compare different methods to account for baseline values of outcome variables in IPD-MA of NRSs using two empirical examples from the Thyroid Studies Collaboration (TSC). Methods: For the first aim we systematically searched in MEDLINE, EMBASE, and Cochrane from inception to February 2021 to identify published IPD-MAs of NRSs that adjusted for baseline outcome measures in the analysis of continuous outcomes. For the second aim, we applied analysis of covariance (ANCOVA), change score, propensity score and the naïve approach (ignores the baseline outcome data) in IPD-MA from NRSs on the association between subclinical hyperthyroidism and depressive symptoms and renal function. We estimated the study and meta-analytic mean difference (MD) and relative standard error (SE). We used both fixed- and random-effects MA. Results: Ten of 18 (56%) of the included studies used the change score method, seven (39%) studies used ANCOVA and one the propensity score (5%). The study estimates were similar across the methods in studies in which groups were balanced at baseline with regard to outcome variables but differed in studies with baseline imbalance. In our empirical examples, ANCOVA and change score showed study results on the same direction, not the propensity score. In our applications, ANCOVA provided more precise estimates, both at study and meta-analytical level, in comparison to other methods. Heterogeneity was higher when change score was used as outcome, moderate for ANCOVA and null with the propensity score. Conclusion: ANCOVA provided the most precise estimates at both study and meta-analytic level and thus seems preferable in the meta-analysis of IPD from non-randomized studies. For the studies that were well-balanced between groups, change score, and ANCOVA performed similarly.
| Originalsprog | Engelsk |
|---|---|
| Artikelnummer | 774251 |
| Tidsskrift | Frontiers in Psychiatry |
| Vol/bind | 13 |
| ISSN | 1664-0640 |
| DOI | |
| Status | Udgivet - 2022 |
Bibliografisk note
Funding Information:
The authors thank Beatrice Minder and Doris Kopp [Institute of Social and Preventive Medicine (ISPM), University of Bern, Switzerland] for helping us develop the literature search strategy, Kali Tal, PhD [Institute of Primary Health Care (BIHAM)], (University of Bern, Switzerland) for editing the manuscript, and the Thyroid Studies Collaboration (www.thyroid-studies.org) for their contribution to this study.
Funding Information:
The work from the Thyroid Studies Collaboration (TSC, www.thyroid-studies.org ) was supported by grants from the Swiss National Science Foundation (SNSF 320030-172676 and 32003B_200606 both to NR). The Busselton Health Study had no financial support to disclose. The Cardiovascular Health Study (CHS) was supported by contracts HHSN268201200036C, HHSN268200800007C, HHSN268201800001C, N01HC55222, N01HC85079, N01HC85080, N01HC85081, N01HC85082, N01HC85083, N01HC85086, 75N92021D00006, and grants U01HL080295 and U01HL130114 from the National Heart, Lung, and Blood Institute (NHLBI), with additional contribution from the National Institute of Neurological Disorders and Stroke (NINDS). Additional support was provided by R01AG023629 from the National Institute on Aging (NIA). A full list of principal CHS investigators and institutions can be found at CHS-NHLBI.org . The European Prospective Investigation of Cancer (EPIC)-Norfolk study was supported by research grants from the Medical Research Council UK and Cancer Research UK. The Health, Aging and Body Composition (Health ABC) study was supported by NIA Contracts N01-AG-6-2101; N01-AG-6-2103; N01-AG-6-2106; NIA grant R01-AG028050 and NINR grant R01-NR012459. This research was funded in part by the Intramural Research Program at the NIA. The InChianti study was supported as a target project ICS 110.1jRS97.71 by the Italian Ministry of Health, and in part by the US NIA, contracts 263-MD-9164-13 and 263-MD-821336. The Trøndelag Health Study (HUNT) is a collaborative effort of HUNT Research Center (Faculty of Medicine and Health Sciences, NTNU, Norwegian University of Science and Technology), the Norwegian Institute of Public Health, Central Norway Regional Health Authority and the Trøndelag County Council. Thyroid function testing in the HUNT Study was financially supported by WallacOy (Turku, Finland). The Leiden 85-plus study was partly funded by an unrestricted grant from the Dutch Ministry of Health, Welfare and Sports (1997–2001). The original PROSPER study was supported by an unrestricted, investigator-initiated grant from Bristol-Myers Squibb. The Rotterdam Study was funded by the following: Erasmus MC and Erasmus University, Rotterdam, the Netherlands; the Netherlands Organisation for Scientific Research (NWO); the Netherlands Organisation for the Health Research and Development (ZonMw); the Research Institute for Diseases in the Elderly (RIDE); the Ministry of Education, Culture and Science; the Dutch Ministry for Health, Welfare and Sports; the European Commission (DG XII); and the Municipality of Rotterdam. The Radiation Effects Research Foundation (RERF), Hiroshima and Nagasaki, Japan, was a public interest foundation funded by the Japanese Ministry of Health, Labour and Welfare (MHLW) and the US Department of Energy (DOE). This publication was supported by RERF Research Protocol A5–13. SHIP was part of the Research Network of Community Medicine at the University Medicine Greifswald, Germany ( www.communitymedicine.de ), which was funded by the German Federal State of Mecklenburg–West Pomerania. The BELFRAIL study was funded by an unconditional grant from the Fondation Louvain. The Fondation Louvain was the support unit of the Université Catholique de Louvain in charge of developing education and research projects of the university by collecting gifts from corporate, foundations and alumni. The Brazilian thyroid study was supported by an unrestricted grant from São Paulo State Research Foundation (Fundacão de Amparo a Pesquisa do Estado de São Paulo) Grant 6/59737-9. The Prevention of Renal and Vascular End-Stage Disease (PREVEND) study has been made possible by grants from the Dutch Kidney Foundation: (E.033).
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Copyright © 2022 Syrogiannouli, Wildisen, Meuwese, Bauer, Cappola, Gussekloo, den Elzen, Trompet, Westendorp, Jukema, Ferrucci, Ceresini, Åsvold, Chaker, Peeters, Imaizumi, Ohishi, Vaes, Völzke, Sgarbi, Walsh, Dullaart, Bakker, Iacoviello, Rodondi and Del Giovane.
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