COVID-19 vaccination breakthrough infections in a real-world setting: Using community reporters to evaluate vaccine effectiveness

Background COVID-19 has highlighted the need for new methods of pharmacovigilance. Here we use community volunteers to obtain systematic information on vaccine effectiveness and the nature and severity of breakthrough infections. Methods Between December 15, 2020 to September 16, 2021, 10,412 unpaid community-based participants reported the following information to an on-line registry: COVID-19 test results, vaccination (Pfizer, Moderna, or Johnson & Johnson), COVID-19 symptoms and perceived severity using a 4-point scale. COVID-19 infections were described for those who were 1) fully vaccinated, 2) partially vaccinated (received first of two dose vaccines or were <14 days post-final dose), or 3) unvaccinated. Results Of 8,554 who were vaccinated, COVID-19 infections were reported by 74 (1.0%) of those who were fully vaccinated and 198 (2.3%) of those who were partially vaccinated. Among the 74 participants who reported a breakthrough infection after full vaccination, the median time to reported positive test result was 104.5 days (Interquartile range: 77-135 days), with no difference among vaccine manufactures. One quarter (25.7%) of breakthrough infections in the fully vaccinated cases were asymptomatic. More than 97% of fully vaccinated participants reported no moderate/severe symptoms compared to 89.3% of the unvaccinated cases; and only 1.4% of fully vaccinated participants reported experiencing at least 3 moderate to severe symptoms compared to 7.8% in the unvaccinated. Conclusion Person-generated health data, also referred to as patient-reported outcomes, is a useful resource for quantifying breakthrough infections and their severity, showing here that fully vaccinated participants report no or very mild COVID-19 symptoms.

Download Full-text

Oxygen saturation improved with nitrate-based nutritional formula in patients with COVID-19

Journal of International Medical Research ◽

10.1177/03000605211012380 ◽

2021 ◽

Vol 49 (4) ◽

pp. 030006052110123

Author(s):

Sergej M. Ostojic ◽

Aleksandra Milovancev ◽

Patrik Drid ◽

Alexandros Nikolaidis

Keyword(s):

Oxygen Saturation ◽

Patient Reported Outcomes ◽

Case Series ◽

Potassium Nitrate ◽

Open Label ◽

Patient Reported ◽

Baseline Values ◽

Study Participants ◽

To Receive ◽

Test Result

In this open-label case series trial, we evaluated the effects of a nitrate-based nutritional formula on oxygen saturation (SpO2) and patient-reported outcomes in individuals with coronavirus disease 2019 (COVID-19). Five adult patients (three men and two women, age 39.6 ± 6.9 years) with a positive COVID-19 test result, breathing difficulties, and SpO2 ≤95%, who were free from other pulmonary and cardiovascular conditions, were recruited for this study. Participants were assigned to receive a multi-component nutritional formula (containing 1200 mg of potassium nitrate, 200 mg of magnesium, 50 mg of zinc, and 1000 mg of citric acid) every 4 hours during the 48-hour monitoring period. In all participants, SpO2 improved immediately after administration of the nutritional formula, from 1 to 7 percentage points (mean increase 3.6 ± 2.7 points; 95% confidence interval 0.3 to 7.0). SpO2 remained above baseline values throughout the monitoring interval, with values persisting over threshold values (>92%) for all patients and at each time point during the 48 hours. No patients reported any side effects of the intervention. These promising and rather unexpected results call for immediate, well-sampled, mechanistic randomized controlled trials to validate our findings.

Download Full-text

Responsiveness of 8 Patient-Reported Outcomes Measurement Information System (PROMIS) measures in a large, community-based cancer study cohort

Cancer ◽

10.1002/cncr.30354 ◽

2016 ◽

Vol 123 (2) ◽

pp. 327-335 ◽

Cited By ~ 25

Author(s):

Roxanne E. Jensen ◽

Carol M. Moinpour ◽

Arnold L. Potosky ◽

Tania Lobo ◽

Elizabeth A. Hahn ◽

...

Keyword(s):

Information System ◽

Patient Reported Outcomes ◽

Measurement Information ◽

Study Cohort ◽

Community Based ◽

Outcomes Measurement ◽

Cancer Study ◽

Large Community ◽

Patient Reported ◽

Measurement Information System

Download Full-text

Impact of depressive symptoms on self-perceived severity of autonomic dysfunction in multiple system atrophy: relevance for patient-reported outcomes in clinical trials

Clinical Autonomic Research ◽

10.1007/s10286-020-00681-6 ◽

2020 ◽

Vol 30 (3) ◽

pp. 215-221

Author(s):

Jose Martinez ◽

Jose-Alberto Palma ◽

Lucy Norcliffe-Kaufmann ◽

Amir Garakani ◽

Horacio Kaufmann

Keyword(s):

Clinical Trials ◽

Depressive Symptoms ◽

Multiple System Atrophy ◽

Autonomic Dysfunction ◽

Patient Reported Outcomes ◽

Perceived Severity ◽

Patient Reported

Download Full-text

PMS79 USE OF PATIENT-REPORTED OUTCOMES IN ON-LINE COMMUNITIES TO CONDUCT OBSERVATIONAL COMPARATIVE EFFECTIVENESS RESEARCH: A PILOT STUDY IN RHEUMATOID ARTHRITIS

Value in Health ◽

10.1016/s1098-3015(11)72232-x ◽

2010 ◽

Vol 13 (7) ◽

pp. A318

Author(s):

E Cascade ◽

M Bharmal

Keyword(s):

Rheumatoid Arthritis ◽

Pilot Study ◽

Comparative Effectiveness Research ◽

Comparative Effectiveness ◽

Patient Reported Outcomes ◽

Effectiveness Research ◽

Patient Reported ◽

On Line

Download Full-text

Use and Patient-Reported Outcomes of Clinical Multigene Panel Testing for Cancer Susceptibility in the Multicenter Communication of Genetic Test Results by Telephone Study

JCO Precision Oncology ◽

10.1200/po.18.00199 ◽

2018 ◽

pp. 1-12

Author(s):

Michael J. Hall ◽

Linda J. Patrick-Miller ◽

Brian L. Egleston ◽

Susan M. Domchek ◽

Mary B. Daly ◽

...

Keyword(s):

State Anxiety ◽

Patient Reported Outcomes ◽

Genetic Test ◽

Cancer Susceptibility ◽

Randomized Study ◽

Test Results ◽

Genetic Test Results ◽

Patient Reported ◽

Targeted Testing ◽

Anxiety Depression

Purpose Multigene panels (MGPs) are increasingly being used despite questions regarding their clinical utility and no standard approach to genetic counseling. How frequently genetic providers use MGP testing and how patient-reported outcomes (PROs) differ from targeted testing (eg, BRCA1/2 only) are unknown. Methods We evaluated use of MGP testing and PROs in participants undergoing cancer genetic testing in the multicenter Communication of Genetic Test Results by Telephone study (ClinicalTrials.gov identifier: NCT01736345), a randomized study of telephone versus in-person disclosure of genetic test results. PROs included genetic knowledge, general and state anxiety, depression, cancer-specific distress, uncertainty, and satisfaction. Genetic providers offered targeted or MGP testing based on clinical assessment. Results Since the inclusion of MGP testing in 2014, 395 patients (66%) were offered MGP testing. MGP testing increased over time from 57% in 2014 to 66% in 2015 ( P = .02) and varied by site (46% to 78%; P < .01). Being offered MGP testing was significantly associated with not having Ashkenazi Jewish ancestry, having a history of cancer, not having a mutation in the family, not having made a treatment decision, and study site. After demographic adjustment, patients offered MGP testing had lower general anxiety ( P = .04), state anxiety ( P = .03), depression ( P = .04), and uncertainty ( P = .05) pre-disclosure compared with patients offered targeted testing. State anxiety ( P = .05) and cancer-specific distress ( P = .05) were lower at disclosure in the MGP group. There was a greater increase in change in uncertainty ( P = .04) among patients who underwent MGP testing. Conclusion MGP testing was more frequently offered to patients with lower anxiety, depression, and uncertainty and was associated with favorable outcomes, with the exception of a greater increase in uncertainty compared with patients who had targeted testing. Addressing uncertainty may be important as MGP testing is increasingly adopted.

Download Full-text