Evans SJW, Jewell NP. Vaccine effectiveness studies in the field. N Engl J Med. 2021;385(7):650–1.

CAS  Article  Google Scholar 

Pilz S, Theiler-Schwetz V, Trummer C, Krause R, Ioannidis JPA. SARS-CoV-2 reinfections: overview of efficacy and duration of natural and hybrid immunity. Environ Res. 2022;209:112911.

CAS  Article  Google Scholar 

Korang SK, von Rohden E, Veroniki AA, Ong G, Ngalamika O, Siddiqui F, Juul S, Nielsen EE, Feinberg JB, Petersen JJ, Legart C, Kokogho A, Maagaard M, Klingenberg S, Thabane L, Bardach A, Ciapponi A, Thomsen AR, Jakobsen JC, Gluud C. Vaccines to prevent COVID-19: a living systematic review with trial sequential analysis and network meta-analysis of randomized clinical trials. PLoS ONE. 2022;17(1):e0260733.

CAS  Article  Google Scholar 

Kow CSC, Ramachandram DS, Hasan SS. The effectiveness of BNT162b2 mRNA vaccine against COVID-19 caused by Delta variant of SARS-CoV-2: a systematic review and meta-analysis. Inflammopharmacology. 2022;31:1–9.

Google Scholar 

Cheng CJ, Lu CY, Chang YH, Sun Y, Chu HJ, Lee CY, Liu CH, Lin CH, Lu CJ, Li CY. Effectiveness of the WHO-authorized COVID-19 vaccines: a rapid review of global reports till 30 June 2021. Vaccines (Basel). 2021;9(12):1489.

CAS  Article  Google Scholar 

Cohn BA, Cirillo PM, Murphy CC, Krigbaum NY, Wallace AW. SARS-CoV-2 vaccine protection and deaths among US veterans during 2021. Science. 2022;375(6578):331–6.

CAS  Article  Google Scholar 

Barda N, Dagan N, Cohen C, Hernán MA, Lipsitch M, Kohane IS, Reis BY, Balicer RD. Effectiveness of a third dose of the BNT162b2 mRNA COVID-19 vaccine for preventing severe outcomes in Israel: an observational study. Lancet. 2021;398(10316):2093–100.

CAS  Article  Google Scholar 

Lin DY, Gu Y, Wheeler B, Young H, Holloway S, Sunny SK, Moore Z, Zeng D. Effectiveness of Covid-19 vaccines over a 9-month period in North Carolina. N Engl J Med. 2022;386:933–41.

CAS  Article  Google Scholar 

Cerqueira-Silva T, Katikireddi SV, de Araujo Oliveira V, Flores-Ortiz R, Júnior JB, Paixão ES, Robertson C, Penna GO, Werneck GL, Barreto ML, Pearce N, Sheikh A, Barral-Netto M, Boaventura VS. Vaccine effectiveness of heterologous CoronaVac plus BNT162b2 in Brazil. Nat Med. 2022. https://doi.org/10.1038/s41591-022-01701-w.

Article  PubMed  PubMed Central  Google Scholar 

Nordström P, Ballin M, Nordström A. Risk of infection, hospitalisation, and death up to 9 months after a second dose of COVID-19 vaccine: a retrospective, total population cohort study in Sweden. Lancet. 2022;S0140–6736(22):00089–97.

Google Scholar 

Andrews N, Tessier E, Stowe J, Gower C, Kirsebom F, Simmons R, Gallagher E, Thelwall S, Groves N, Dabrera G, Myers R, Campbell CNJ, Amirthalingam G, Edmunds M, Zambon M, Brown K, Hopkins S, Chand M, Ladhani SN, Ramsay M, Lopez Bernal J. Duration of protection against mild and severe disease by Covid-19 vaccines. N Engl J Med. 2022;386(4):340–50.

CAS  Article  Google Scholar 

Chemaitelly H, Tang P, Hasan MR, AlMukdad S, Yassine HM, Benslimane FM, Al Khatib HA, Coyle P, Ayoub HH, Al Kanaani Z, Al Kuwari E, Jeremijenko A, Kaleeckal AH, Latif AN, Shaik RM, Abdul Rahim HF, Nasrallah GK, Al Kuwari MG, Al Romaihi HE, Butt AA, Al-Thani MH, Al Khal A, Bertollini R, Abu-Raddad LJ. Waning of BNT162b2 vaccine protection against SARS-CoV-2 infection in Qatar. N Engl J Med. 2021;385(24):e83.

CAS  Article  Google Scholar 

Rosenberg ES, Holtgrave DR, Dorabawila V, Conroy M, Greene D, Lutterloh E, Backenson B, Hoefer D, Morne J, Bauer U, Zucker HA. New COVID-19 cases and hospitalizations among adults, by vaccination status—New York, May 3–July 25, 2021. MMWR Morb Mortal Wkly Rep. 2021;70(34):1150–5.

CAS  Article  Google Scholar 

Halloran ME, Longini IM Jr, Struchiner CJ. Design and interpretation of vaccine field studies. Epidemiol Rev. 1999;21:73–88.

CAS  Article  Google Scholar 

Hanquet G, Valenciano M, Simondon F, Moren A. Vaccine effects and impact of vaccination programmes in post-licensure studies. Vaccine. 2013;31:5634–42.

Article  Google Scholar 

Lewnard JA, Patel MM, Jewell NP, et al. Theoretical framework for retrospective studies of the effectiveness of SARS-CoV-2 vaccines. Epidemiology. 2021;32:508–17.

Article  Google Scholar 

Ioannidis JPA. Factors influencing estimated effectiveness of COVID-19 vaccines in non-randomised studies. BMJ Evid Based Med. 2022. https://doi.org/10.1136/bmjebm-2021-111901.

Article  PubMed  Google Scholar 

Ioannidis JP, Cappelleri JC, Lau J, Skolnik PR, Melville B, Chalmers TC, Sacks HS. Early or deferred zidovudine therapy in HIV-infected patients without an AIDS-defining illness. Ann Intern Med. 1995;122(11):856–66.

CAS  Article  Google Scholar 

Mehrotra DV, Janes HE, Fleming TR, et al. Clinical endpoints for evaluating efficacy in COVID-19 vaccine trials. Ann Intern Med. 2021;174:221–8.

Article  Google Scholar 

Matsuyama Y, Morita S. Estimation of the average causal effect among subgroups defined by post-treatment variables. Clin Trials. 2006;3(1):1–9.

Article  Google Scholar 

Peng Y, Little RJ, Raghunathan TE. An extended general location model for causal inferences from data subject to noncompliance and missing values. Biometrics. 2004;60(3):598–607.

Article  Google Scholar 

Frangakis CE, Rubin DB. Principal stratification in causal inference. Biometrics. 2002;58(1):21–9.

Article  Google Scholar 

Gilbert PB, Bosch RJ, Hudgens MG. Sensitivity analysis for the assessment of causal vaccine effects on viral load in HIV vaccine trials. Biometrics. 2003;59:531–41.

Article  Google Scholar 

Novelli M, Baldi Antognini A, Boffetta P, Ioannidis JP, Spatari G, Violante FS. Reporting only relative effect measures was potentially misleading: some good practices for improving the soundness of epidemiological results. J Clin Epidemiol. 2021;137:195–9.

Article  Google Scholar 

Axfors C, Ioannidis JPA. Infection fatality rate of COVID-19 in community-dwelling elderly populations. Eur J Epidemiol. 2022;37:235–49.

CAS  Article  Google Scholar 

Sinclair JC, Cook RJ, Guyatt GH, Pauker SG, Cook DJ. When should an effective treatment be used? Derivation of the threshold number needed to treat and the minimum event rate for treatment. J Clin Epidemiol. 2001;54(3):253–62.

CAS  Article  Google Scholar 

Mumford SL, Schisterman EF. New methods for generalizability and transportability: the new norm. Eur J Epidemiol. 2019;34(8):723–4.

Article  Google Scholar 

Agoritsas T, Heen AF, Brandt L, Alonso-Coello P, Kristiansen A, Akl EA, Neumann I, Tikkinen KA, Weijden T, Elwyn G, Montori VM, Guyatt GH, Vandvik PO. Decision aids that really promote shared decision making: the pace quickens. BMJ. 2015;350:g7624.

Article  Google Scholar 

Politi MC, Dizon DS, Frosch DL, Kuzemchak MD, Stiggelbout AM. Importance of clarifying patients’ desired role in shared decision making to match their level of engagement with their preferences. BMJ. 2013;347:f7066.

Article  Google Scholar 

Stiggelbout AM, Van der Weijden T, De Wit MP, Frosch D, Légaré F, Montori VM, Trevena L, Elwyn G. Shared decision making: really putting patients at the centre of healthcare. BMJ. 2012;344:e256.

CAS  Article  Google Scholar 

Committee on Quality of Health Care in America. Crossing the quality chasm: a new health system for the 21st century. Washington: National Academies Press; 2001.

Google Scholar 

Porter M, Pabo E, Lee T. Redesigning primary care: a strategic vision to improve value by organizing around patients’ needs. Health Aff. 2013;32(3):516–25.

Article  Google Scholar 

Russo S, Jongerius C, Faccio F, Pizzoli S, Pinto C, Veldwijk J, et al. Understanding patients’ preferences: a systematic review of psychological instruments used in patients’ preference and decision studies. Value Health. 2019;22(4):491–501.

Article  Google Scholar 

Hirpa M, Woreta T, Addis H, Kebede S. What matters to patients? A timely question for value-based care. PLoS ONE. 2020;15(7):e0227845.

CAS  Article  Google Scholar 

Shah A. Value-based health care, a global assessment. London: The Economist Intelligence Unit; 2016.

Google Scholar