O’Mareen Spence
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Effectiveness and safety of the recombinant zoster vaccine in adult patients with systemic lupus erythematosus: a claims-based retrospective cohort study in the USA Open
Objectives To assess vaccine effectiveness (VE) and safety of the recombinant zoster vaccine (RZV) in adults with systemic lupus erythematosus (SLE). Methods This retrospective study using administrative claims data collected between 1 Jan…
A prospective, multi-center post-marketing surveillance cohort study to monitor the safety of the recombinant zoster vaccine in Chinese adults ≥50 years of age Open
This post-marketing surveillance study evaluated the safety of the adjuvanted recombinant zoster vaccine (RZV) in Chinese adults, given the limited country-specific safety data accumulated since the 2019 licensure of RZV in China for adult…
Risk of incident gout following exposure to recombinant zoster vaccine in US adults aged ≥50 years Open
In a population of US adults aged ≥50 years, there was no statistically significant increase in the risk of gout during the 30 days immediately after RZV exposure, compared with a subsequent 30-day CW.
Real-world effectiveness of recombinant zoster vaccine in self-identified Chinese individuals aged ≥50 years in the United States Open
We evaluated the vaccine effectiveness (VE) of two doses of recombinant zoster vaccine (RZV) against herpes zoster (HZ) and postherpetic neuralgia (PHN) in Chinese adults at Kaiser Permanente Southern California (KPSC). Chinese KPSC member…
Geographic Trends in Pediatric Psychotropic Medication Dispensing Before and After the Start of the COVID-19 Pandemic Open
Fewer psychotropic medications were dispensed to U.S. youths after the start of the COVID-19 pandemic compared with 2019. Although some medication classes rebounded to prepandemic dispensing levels by September 2020, dispensing varied by c…
Cardiovascular Risk of Concomitant Use of Atypical Antipsychotics and Stimulants Among Commercially Insured Youth in the United States Open
Objectives: To investigate the risk of cardiovascular events associated with concomitant use of stimulants and atypical antipsychotics (AAPs) among youth and evaluate whether AAP dose and duration of concomitant use modifies the risk. Meth…
Incompletely Reported Important Methodological Details and Inaccurate Description of the Formulation That the Control Arms Received in a Gardasil Vaccine Trial Open
The Restoring Invisible and Abandoned Trials (RIAT) initiative is an international effort concerned with two fundamental problems in the scientific literature on clinical trials: many trials are inaccurately or incompletely reported in jou…
Characteristics of Youths Treated With Psychotropic Polypharmacy in the United States, 1999 to 2015 Open
This study investigates differences in the characteristics of US youths treated with psychotropic polypharmacy and in the psychotropic classes used in combination.
Adjuvant-containing control arms in pivotal quadrivalent human papillomavirus vaccine trials: restoration of previously unpublished methodology Open
Purpose Trustworthy reporting of quadrivalent human papillomavirus (HPV) vaccine trials is the foundation for assessing the vaccine’s risks and benefits. However, several pivotal trial publications incompletely reported important methodolo…
Communication of Nonefficacy Benefits of New Drugs Approved on the Basis of Noninferiority Trials Alone Open
This cohort study of FDA- and drug sponsor–written communications evaluates the communication of nonefficacy benefits of new drugs approved on the basis of noninferiority trials alone.
Dataset For Spence Et Al., "Availability Of Study Protocols For Randomized Trials Published In High-Impact Medical Journals: Cross-Sectional Analysis" (Citation) Open
Contains our extraction sheets (as SAS data files), code to calculate the values in the tables in our manuscript, and a supplemental file with additional notes on methods used in our study.
Dataset for Spence et al., "Availability of study protocols for randomized trials published in high-impact medical journals: cross-sectional analysis" (CITATION) Open
Contains our extraction sheets (as SAS data files), code to calculate the values in the tables in our manuscript, and a supplemental file with additional notes on methods used in our study.
Dataset for Spence et al., "Availability of study protocols for randomized trials published in high-impact medical journals: cross-sectional analysis" (CITATION) Open
Contains our extraction sheets (as SAS data files), code to calculate the values in the tables in our manuscript, and a supplemental file with additional notes on methods used in our study.
Dataset for Spence et al., "Availability of study protocols for randomized trials published in high-impact medical journals: cross-sectional analysis" (CITATION) Open
Contains our extraction sheets (as SAS data files), code to calculate the values in the tables in our manuscript, and a supplemental file with additional notes on methods used in our study.
Dataset For Spence Et Al., "Availability Of Study Protocols For Randomized Trials Published In High-Impact Medical Journals: Cross-Sectional Analysis" (Citation) Open
Contains our extraction sheets (as SAS data files), code to calculate the values in the tables in our manuscript, and a supplemental file with additional notes on methods used in our study.
Dataset For Spence Et Al., "Availability Of Study Protocols For Randomized Trials Published In High-Impact Medical Journals: Cross-Sectional Analysis" (Citation) Open
Contains our extraction sheets (as SAS data files), code to calculate the values in the tables in our manuscript, and a supplemental file with additional notes on methods used in our study.
Dataset For Spence Et Al., "Patient Consent To Publication And Data Sharing In Industry And Nih-Funded Clinical Trials" (Trials 2018 19:269). Open
Dataset for our journal publication (Spence et al. 2018 https://doi.org/10.1186/s13063-018-2651-2). This dataset contains Informed consent forms (ICFs) for 98 industry-funded clinical trials Informed consent forms (ICFs) for 46 NIH-funded …
Dataset For Spence Et Al., "Patient Consent To Publication And Data Sharing In Industry And Nih-Funded Clinical Trials" (Trials 2018 19:269). Open
Dataset for our journal publication (Spence et al. 2018 https://doi.org/10.1186/s13063-018-2651-2). This dataset contains Informed consent forms (ICFs) for 98 industry-funded clinical trials Informed consent forms (ICFs) for 46 NIH-funded …