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The Lancet. Infectious Diseases Jul 2022The incidence of invasive disease caused by group A streptococcus (GAS) has increased in multiple countries in the past 15 years. However, despite these reports, to the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The incidence of invasive disease caused by group A streptococcus (GAS) has increased in multiple countries in the past 15 years. However, despite these reports, to the best of our knowledge, no systematic reviews and combined estimates of the incidence of invasive GAS have been done in key high-risk groups. To address this, we estimated the incidence of invasive GAS disease, including death and disability outcomes, among two high-risk groups-namely, pregnant women and children younger than 5 years.
METHODS
We did a systematic review and meta-analyses on invasive GAS outcomes, including incidence, case fatality risks, and neurodevelopmental impairment risk, among pregnant women, neonates (younger than 28 days), infants (younger than 1 year), and children (younger than 5 years) worldwide and by income region. We searched several databases for articles published from Jan 1, 2000, to June 3, 2020, for publications that reported invasive GAS outcomes, and we sought unpublished data from an investigator group of collaborators. We included studies with data on invasive GAS cases, defined as laboratory isolation of Streptococcus pyogenes from any normally sterile site, or isolation of S pyogenes from a non-sterile site in a patient with necrotising fasciitis or streptococcal toxic shock syndrome. For inclusion in pooled incidence estimates, studies had to report a population denominator, and for inclusion in pooled estimates of case fatality risk, studies had to report aggregate data on the outcome of interest and the total number of cases included as a denominator. We excluded studies focusing on groups at very high risk (eg, only preterm infants). We assessed heterogeneity with I.
FINDINGS
Of the 950 published articles and 29 unpublished datasets identified, 20 studies (seven unpublished; 3829 cases of invasive GAS) from 12 countries provided sufficient data to be included in pooled estimates of outcomes. We did not identify studies reporting invasive GAS incidence among pregnant women in low-income and middle-income countries (LMICs) nor any reporting neurodevelopmental impairment after invasive GAS in LMICs. In nine studies from high-income countries (HICs) that reported invasive GAS in pregnancy and the post-partum period, invasive GAS incidence was 0·12 per 1000 livebirths (95% CI 0·11 to 0·14; I=100%). Invasive GAS incidence was 0·04 per 1000 livebirths (0·03 to 0·05; I=100%; 11 studies) for neonates, 0·13 per 1000 livebirths (0·10 to 0·16; I=100%; ten studies) for infants, and 0·09 per 1000 person-years (95% CI 0·07 to 0·10; I=100%; nine studies) for children worldwide; 0·12 per 1000 livebirths (95% CI 0·00 to 0·24; I=100%; three studies) in neonates, 0·33 per 1000 livebirths (-0·22 to 0·88; I=100%; two studies) in infants, and 0·22 per 1000 person-years (0·13 to 0·31; I=100%; two studies) in children in LMICs; and 0·02 per 1000 livebirths (0·00 to 0·03; I=100%; eight studies) in neonates, 0·08 per 1000 livebirths (0·05 to 0·11; I=100%; eight studies) in infants, and 0·05 per 1000 person-years (0·03 to 0·06; I=100%; seven studies) in children for HICs. Case fatality risks were high, particularly among neonates in LMICs (61% [95% CI 33 to 89]; I=54%; two studies).
INTERPRETATION
We found a substantial burden of invasive GAS among young children. In LMICs, little data were available for neonates and children and no data were available for pregnant women. Incidences of invasive GAS are likely to be underestimates, particularly in LMICs, due to low GAS surveillance. It is essential to improve available data to inform development of prevention and management strategies for invasive GAS.
FUNDING
Wellcome Trust.
Topics: Child; Child, Preschool; Female; Humans; Incidence; Infant; Infant, Newborn; Infant, Premature; Pregnancy; Pregnant Women; Streptococcal Infections; Streptococcus pyogenes
PubMed: 35390294
DOI: 10.1016/S1473-3099(21)00672-1 -
BMC Medical Research Methodology Mar 2022The need to mitigate the volume of unplanned emergency department (ED) presentations is a priority for health systems globally. Current evidence on the incidence and...
Methodological approaches to measuring the incidence of unplanned emergency department presentations by cancer patients receiving systemic anti-cancer therapy: a systematic review.
BACKGROUND
The need to mitigate the volume of unplanned emergency department (ED) presentations is a priority for health systems globally. Current evidence on the incidence and risk factors associated with unplanned ED presentations is unclear because of substantial heterogeneity in methods reporting on this issue. The aim of this review was to examine the methodological approaches to measure the incidence of unplanned ED presentations by patients receiving systemic anti-cancer therapy in order to determine the strength of evidence and to inform future research.
METHODS
An electronic search of Medline, Embase, CINAHL, and Cochrane was undertaken. Papers published in English language between 2000 and 2019, and papers that included patients receiving systemic anti-cancer therapy as the denominator during the study period were included. Studies were eligible if they were analytical observational studies. Data relating to the methods used to measure the incidence of ED presentations by patients receiving systemic anti-cancer therapy were extracted and assessed for methodological rigor. Findings are reported in accordance with the Synthesis Without Meta-Analysis (SWiM) guideline.
RESULTS
Twenty-one articles met the inclusion criteria: 20 cohort studies, and one cross-sectional study. Overall risk of bias was moderate. There was substantial methodological and clinical heterogeneity in the papers included. Methodological rigor varied based on the description of methods such as the period of observation, loss to follow-up, reason for ED presentation and statistical methods to control for time varying events and potential confounders.
CONCLUSIONS
There is considerable diversity in the population and methods used in studies that measure the incidence of unplanned ED presentations by patients receiving systemic anti-cancer therapy. Recommendations to support the development of robust evidence include enrolling participants at diagnosis or initiation of treatment, providing adequate description of regular care to support patients who experience toxicities, reporting reasons for and characteristics of participants who are lost to follow-up throughout the study period, clearly defining the outcome including the observation and follow-up period, and reporting crude numbers of ED presentations and the number of at-risk days to account for variation in the length of treatment protocols.
Topics: Clinical Protocols; Cross-Sectional Studies; Emergency Service, Hospital; Humans; Incidence; Neoplasms
PubMed: 35313807
DOI: 10.1186/s12874-022-01555-3 -
Frontiers in Reproductive Health 2021Robust data summarizing the prevalence of pregnancy and neonatal outcomes in low- and middle-income countries are critically important for studies evaluating...
Pooled Prevalence of Adverse Pregnancy and Neonatal Outcomes in Malawi, South Africa, Uganda, and Zimbabwe: Results From a Systematic Review and Meta-Analyses to Inform Trials of Novel HIV Prevention Interventions During Pregnancy.
BACKGROUND
Robust data summarizing the prevalence of pregnancy and neonatal outcomes in low- and middle-income countries are critically important for studies evaluating investigational products for HIV prevention and treatment in pregnant and breastfeeding women. In preparation for studies evaluating the safety of the dapivirine vaginal ring for HIV prevention in pregnancy, we conducted a systematic literature review and meta-analyses to summarize the prevalence of pregnancy and neonatal outcomes in Malawi, South Africa, Uganda, and Zimbabwe.
METHODS
Ten individual systematic literature reviews were conducted to identify manuscripts presenting prevalence data for 12 pregnancy and neonatal outcomes [pregnancy loss, stillbirth, preterm birth, low birthweight (LBW), neonatal mortality, congenital anomaly, chorioamnionitis, postpartum endometritis, postpartum hemorrhage, gestational hypertension, preeclampsia/eclampsia, and preterm premature rupture of membranes (PPROM)]. Studies included in the meta-analyses were published between January 1, 1998, and July 11, 2018, provided numerator and denominator data to support prevalence estimation, and included women of any HIV serostatus. Random-effects meta-analyses were conducted to estimate the pooled prevalence and 95% confidence interval (CI) for each outcome overall, by country, and by HIV status.
RESULTS
A total of 152 manuscripts were included across the 12 outcomes. Overall, the frequency of stillbirth ( = 75 estimates), LBW ( = 68), and preterm birth ( = 67) were the most often reported. However, fewer than 10 total manuscripts reported prevalence estimates for chorioamnionitis, endometritis, or PPROM. The outcomes with the highest pooled prevalence were preterm birth (12.7%, 95%CI 11.2-14.3), LBW (11.7%, 95%CI 10.6-12.9), and gestational hypertension (11.4%, 95%CI 7.8-15.7). Among the outcomes with the lowest pooled prevalence estimates were neonatal mortality (1.7%, 95%CI 1.4-2.1), pregnancy loss [1.9%, 95%CI 1.1-2.8, predominately studies (23/29) assessing losses occurring after the first trimester], PPROM (2.2%, 95%CI 1.5-3.2), and stillbirth (2.5%, 95%CI 2.2-2.7).
CONCLUSIONS
Although this review identified numerous prevalence estimates for some outcomes, data were lacking for other important pregnancy-related conditions. Additional research in pregnant populations is needed for a thorough evaluation of investigational products, including for HIV prevention and treatment, and to inform better estimates of the burden of adverse pregnancy outcomes globally.
PubMed: 35187529
DOI: 10.3389/frph.2021.672446 -
PLoS Medicine Jan 2022Plasmodium vivax infects an estimated 7 million people every year. Previously, vivax malaria was perceived as a benign condition, particularly when compared to... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Plasmodium vivax infects an estimated 7 million people every year. Previously, vivax malaria was perceived as a benign condition, particularly when compared to falciparum malaria. Reports of the severe clinical impacts of vivax malaria have been increasing over the last decade.
METHODS AND FINDINGS
We describe the main clinical impacts of vivax malaria, incorporating a rapid systematic review of severe disease with meta-analysis of data from studies with clearly defined denominators, stratified by hospitalization status. Severe anemia is a serious consequence of relapsing infections in children in endemic areas, in whom vivax malaria causes increased morbidity and mortality and impaired school performance. P. vivax infection in pregnancy is associated with maternal anemia, prematurity, fetal loss, and low birth weight. More than 11,658 patients with severe vivax malaria have been reported since 1929, with 15,954 manifestations of severe malaria, of which only 7,157 (45%) conformed to the World Health Organization (WHO) diagnostic criteria. Out of 423 articles, 311 (74%) were published since 2010. In a random-effects meta-analysis of 85 studies, 68 of which were in hospitalized patients with vivax malaria, we estimated the proportion of patients with WHO-defined severe disease as 0.7% [95% confidence interval (CI) 0.19% to 2.57%] in all patients with vivax malaria and 7.11% [95% CI 4.30% to 11.55%] in hospitalized patients. We estimated the mortality from vivax malaria as 0.01% [95% CI 0.00% to 0.07%] in all patients and 0.56% [95% CI 0.35% to 0.92%] in hospital settings. WHO-defined cerebral, respiratory, and renal severe complications were generally estimated to occur in fewer than 0.5% patients in all included studies. Limitations of this review include the observational nature and small size of most of the studies of severe vivax malaria, high heterogeneity of included studies which were predominantly in hospitalized patients (who were therefore more likely to be severely unwell), and high risk of bias including small study effects.
CONCLUSIONS
Young children and pregnant women are particularly vulnerable to adverse clinical impacts of vivax malaria, and preventing infections and relapse in this groups is a priority. Substantial evidence of severe presentations of vivax malaria has accrued over the last 10 years, but reporting is inconsistent. There are major knowledge gaps, for example, limited understanding of the underlying pathophysiology and the reason for the heterogenous geographical distribution of reported complications. An adapted case definition of severe vivax malaria would facilitate surveillance and future research to better understand this condition.
Topics: Anemia; Humans; Malaria, Vivax; Prevalence
PubMed: 35041650
DOI: 10.1371/journal.pmed.1003890 -
Environment International Jan 2022As part of the development of the World Health Organization (WHO)/International Labour Organization (ILO) Joint Estimates of the Work-related Burden of Disease and...
Assessor burden, inter-rater agreement and user experience of the RoB-SPEO tool for assessing risk of bias in studies estimating prevalence of exposure to occupational risk factors: An analysis from the WHO/ILO Joint Estimates of the Work-related Burden of Disease and Injury.
BACKGROUND
As part of the development of the World Health Organization (WHO)/International Labour Organization (ILO) Joint Estimates of the Work-related Burden of Disease and Injury, WHO and ILO carried out several systematic reviews to determine the prevalence of exposure to selected occupational risk factors. Risk of bias assessment for individual studies is a critical step of a systematic review. No tool existed for assessing the risk of bias in prevalence studies of exposure to occupational risk factors, so WHO and ILO developed and pilot tested the RoB-SPEO tool for this purpose. Here, we investigate the assessor burden, inter-rater agreement, and user experience of this new instrument, based on the abovementioned WHO/ILO systematic reviews.
METHODS
Twenty-seven individual experts applied RoB-SPEO to assess risk of bias. Four systematic reviews provided a total of 283 individual assessments, carried out for 137 studies. For each study, two or more assessors independently assessed risk of bias across the eight RoB-SPEO domains selecting one of RoB-SPEO's six ratings (i.e., "low", "probably low", "probably high", "high", "unclear" or "cannot be determined"). Assessors were asked to report time taken (i.e. indicator of assessor burden) to complete each assessment and describe their user experience. To gauge assessor burden, we calculated the median and inter-quartile range of times taken per individual risk of bias assessment. To assess inter-rater reliability, we calculated a raw measure of inter-rater agreement (P) for each RoB-SPEO domain, between P = 0.00, indicating no agreement and P = 1.00, indicating perfect agreement. As subgroup analyses, P was also disaggregated by systematic review, assessor experience with RoB-SPEO (≤10 assessments versus > 10 assessments), and assessment time (tertiles: ≤25 min versus 26-66 min versus ≥ 67 min). To describe user experience, we synthesised the assessors' comments and recommendations.
RESULTS
Assessors reported a median of 40 min to complete one assessment (interquartile range 21-120 min). For all domains, raw inter-rater agreement ranged from 0.54 to 0.82. Agreement varied by systematic review and assessor experience with RoB-SPEO between domains, and increased with increasing assessment time. A small number of users recommended further development of instructions for selected RoB-SPEO domains, especially bias in selection of participants into the study (domain 1) and bias due to differences in numerator and denominator (domain 7).
DISCUSSION
Overall, our results indicated good agreement across the eight domains of the RoB-SPEO tool. The median assessment time was comparable to that of other risk of bias tools, indicating comparable assessor burden. However, there was considerable variation in time taken to complete assessments. Additional time spent on assessments may improve inter-rater agreement. Further development of the RoB-SPEO tool could focus on refining instructions for selected RoB-SPEO domains and additional testing to assess agreement for different topic areas and with a wider range of assessors from different research backgrounds.
Topics: Bias; Cost of Illness; Humans; Occupational Diseases; Occupational Exposure; Prevalence; Reproducibility of Results; World Health Organization
PubMed: 34991265
DOI: 10.1016/j.envint.2021.107005 -
Journal of Preventive Medicine and... Jun 2021The ongoing novel coronavirus disease 2019 (COVID-19) is the leading cause of morbidity and mortality due to its contagious nature and absence of vaccine and treatment.... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
The ongoing novel coronavirus disease 2019 (COVID-19) is the leading cause of morbidity and mortality due to its contagious nature and absence of vaccine and treatment. Although numerous primary studies reported extremely variable case fatality rate (CFR) of COVID-19, no review study attempted to estimate the CFR of COVID-19. The current systematic review and meta-analysis were aimed to assess the pooled CFR of COVID-19.
METHODS
Electronic databases: PubMed, Science Direct, Scopus, and Google Scholar were searched to retrieve the eligible primary studies that reported CFR of COVID-19. Keywords: ("COVID-19"OR "COVID-2019" OR "severe acute respiratory syndrome coronavirus 2"OR "severe acute respiratory syndrome coronavirus 2" OR "2019-nCoV" OR "SARS-CoV-2" OR "2019nCoV" OR (("Wuhan" AND ("coronavirus" OR "coronavirus")) AND (2019/12[PDAT] OR 2020[PDAT]))) AND ("mortality "OR "mortality" OR ("case" AND "fatality" AND "rate") OR "case fatality rate") were used as free text and MeSH term in searching process. A random-effects model was used to estimate the CFR in this study. I statistics, Cochran's Q test, and T were used to assess the functional heterogeneity between included studies.
RESULTS
The overall pooled CFR of COVID 19 was 10.0%(95% CI: 8.0-11.0); P < 0.001; I = 99.7). The pooled CFR of COVID-19 in general population was 1.0% (95% CI: 1.0-3.0); P < 0.001; I = 94.3), while in hospitalized patients was 13.0% (95% CI: 9.0-17.0); P < 0.001, I = 95.6). The pooled CFR in patients admitted in intensive care unit (ICU) was 37.0% (95% CI: 24.0-51.0); P < 0.001, I = 97.8) and in patients older than 50 years was 19.0% (95% CI: 13.0-24.0); P < 0.001; I = 99.8).
CONCLUSION
The present review results highlighted the need for transparency in testing and reporting policies and denominators used in CFR estimation. It is also necessary to report the case's age, sex, and the comorbidity distribution of all patients, which essential in comparing the CFR among different segments of the population.
Topics: COVID-19; Comorbidity; Female; Humans; Male; SARS-CoV-2; Survival Rate
PubMed: 34604571
DOI: 10.15167/2421-4248/jpmh2021.62.2.1627 -
Obesity Research & Clinical Practice 2021This scoping review provides a timely synthesis of the use of continuous glucose monitoring in obesity research with considerations to adherence to continuous glucose... (Review)
Review
BACKGROUND
This scoping review provides a timely synthesis of the use of continuous glucose monitoring in obesity research with considerations to adherence to continuous glucose monitor devices and metrics most frequently reported.
METHODS
This scoping review was conducted adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist. Eligible studies (n = 31) evaluated continuous glucose monitor use in research on participants, of all ages, with overweight or obesity.
RESULTS
Reviewed studies varied in duration from one to 84 days (mean: 8.74 d, SD 15.2, range 1-84 d) with 889 participants total (range: 11-118 participants). Across all studies, the mean percent continuous glucose monitor wear time (actual/intended wear time in days) was 92% (numerator - mean: 266.1 d, SD: 452, range: 9-1596 d/denominator - mean: 271.6 d, SD: 451.5, range: 9-1596 d). Continuous glucose monitoring was utilized to provide biofeedback (n = 2, 6%), monitor dietary adherence (n = 2, 6%), and assess glycemic variability (n = 29, 93%). The most common variability metrics reported were standard deviation (n = 19, 62%), area under the curve (n = 12, 39%), and glycemic range (n = 12, 39%).
CONCLUSIONS
Available evidence suggests that continuous glucose monitoring is a well-tolerated and versatile tool for obesity research in pediatric and adult patients. Future investigation is needed to substantiate the feasibility and utility of continuous glucose monitors in obesity research and maximize comparability across studies.
Topics: Blood Glucose; Blood Glucose Self-Monitoring; Child; Humans; Obesity
PubMed: 34481746
DOI: 10.1016/j.orcp.2021.08.006 -
Seminars in Arthritis and Rheumatism Oct 2021We performed a systematic review and meta-analysis for the prevalence and risk factors of rheumatoid arthritis-related bronchiectasis (RA-BR). (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
We performed a systematic review and meta-analysis for the prevalence and risk factors of rheumatoid arthritis-related bronchiectasis (RA-BR).
METHODS
We queried PubMed and EMBASE databases to identify published literature related to prevalence and risk factors for RA-BR among patients with RA. Data extraction included study design, country, year, method of RA-BR detection, RA characteristics, numerator of RA-BR cases and denominator of patients with RA, and associations with RA-BR presence. We performed a meta-analysis using random or fixed effects models to estimate the prevalence of RA-BR among RA.
RESULTS
Out of a total of 253 studies, we identified 41 total studies that reported on prevalence (n = 34), risk factors (n = 5), or both (n = 2). The included studies had heterogeneous methods to identify RA-BR. Among the 36 studies reporting prevalence, 608 RA-BR cases were identified from a total of 8569 patients with RA. In the meta-analysis, the pooled overall prevalence of RA-BR among RA was 18.7% (95%CI 13.7-24.3%) using random effects and 3.8% (95%CI 3.3-4.2%) using fixed effects. Among studies that used high-resolution chest computed tomography (HRCT) imaging, the prevalence of RA-BR was 22.6% (95%CI 16.8-29.0%) using random effects. When only considering retrospective studies (n = 12), the pooled prevalence of RA-BR among RA was 15.5% (95%CI 7.5-25.5%); among prospective studies (n = 24), the pooled prevalence was 20.7% (95% CI 14.7-27.4%). Risk factors for RA-BR included older age, longer RA duration, genetics (CFTR and HLA), and undetectable circulating mannose binding lectin (MBL) as a biomarker.
CONCLUSION
In this systematic review and meta-analysis, the prevalence of RA-BR was nearly 20% among studies with HRCT imaging, suggesting that bronchiectasis may be a common extra-articular feature of RA. Relatively few factors have been associated with RA-BR. Future studies should standardize methods to identify RA-BR cases and investigate the natural history and clinical course given the relatively high prevalence among RA.
Topics: Aged; Arthritis, Rheumatoid; Bronchiectasis; Humans; Prevalence; Prospective Studies; Retrospective Studies; Risk Factors
PubMed: 34450505
DOI: 10.1016/j.semarthrit.2021.08.005 -
The Journal of Surgical Research Dec 2021Traumatic diaphragmatic hernia (TDH) is rare in children, most often occurring following blunt thoracoabdominal trauma from high energy mechanisms, such as motor vehicle...
BACKGROUND
Traumatic diaphragmatic hernia (TDH) is rare in children, most often occurring following blunt thoracoabdominal trauma from high energy mechanisms, such as motor vehicle collisions (MVC). We performed a systematic review to describe injury details and management.
METHODS
Following PRISMA guidelines, a systematic literature search was performed to identify publications of blunt TDH in patients < 18 y old. Conflicts were resolved by consensus. Data were collected on demographics, TDH location, mechanism of injury, associated intraabdominal injuries (IAI), management, and outcomes. Denominators vary depending on number of patients with such information reported.
RESULTS
Fifty-eight articles were reviewed with 142 patients with TDH. The median age was seven y (range 0.25-16). Most were left-sided (85 of 126, 67.5%). MVC was the most common mechanism (66 of 142, 46.5%). IAI was present in 50.0% (57 of 114), most commonly liver injuries (25 of 57, 43.9%). Delayed diagnoses occurred in 49.6% (57 of 115, range 8 h-10 y), and were more common with right-sided TDH (76.0% versus 48.5%, P = 0.02). Chest radiography was 59.0% sensitive for TDH, while computed tomography sensitivity was 65.8%. Operative repair was performed on all surviving patients, and all underwent primary diaphragm repair. The overall mortality was 11.3% (n = 16), with four attributable to the TDH. There were no reported recurrences over a median follow-up of 12 mo.
CONCLUSIONS
Pediatric TDH is a rare diagnosis with a high rate of associated IAI and delayed diagnosis. Primary diaphragm repair was performed in all cases. Surgeons should maintain a high suspicion for diaphragm injury in blunt thoracoabdominal trauma.
Topics: Abdominal Injuries; Child; Diaphragm; Hernia, Diaphragmatic, Traumatic; Humans; Thoracic Injuries; Wounds, Nonpenetrating
PubMed: 34392178
DOI: 10.1016/j.jss.2021.07.011 -
Clinical Infectious Diseases : An... Apr 2022Vaccine regulatory decision making is based on vaccine efficacy against etiologically confirmed outcomes, which may underestimate the preventable disease burden. To...
Vaccine-Preventable Disease Incidence Based on Clinically, Radiologically, and Etiologically Confirmed Outcomes: Systematic Literature Review and Re-analysis of Pneumococcal Conjugate Vaccine Efficacy Trials.
BACKGROUND
Vaccine regulatory decision making is based on vaccine efficacy against etiologically confirmed outcomes, which may underestimate the preventable disease burden. To quantify this underestimation, we compared vaccine-preventable disease incidence (VPDI) of clinically defined outcomes with radiologically/etiologically confirmed outcomes.
METHODS
We performed a systematic review of efficacy trials for several vaccines (1997-2019) and report results for pneumococcal conjugate vaccines. Data were extracted for outcomes within a clinical syndrome, organized from most sensitive to most specific. VPDI was determined for each outcome, and VPDI ratios were calculated, with a clinically defined outcome (numerator) and a radiologically/etiologically confirmed outcome (denominator).
RESULTS
Among 9 studies, we calculated 27 VPDI ratios; 24 had a value >1. Among children, VPDI ratios for clinically defined versus vaccine serotype otitis media were 0.6 (95% CI not calculable), 2.1 (1.5-3.0), and 3.7 (1.0-10.2); the VPDI ratios comparing clinically defined with radiologically confirmed pneumonia ranged from not calculable to 2.7 (1.2-10.4); the VPDI ratio comparing clinically suspected invasive pneumococcal disease (IPD) with laboratory-confirmed IPD was 3.8 (95% CI not calculable). Among adults, the ratio comparing clinically defined with radiologically confirmed pneumonia was 1.9 (-6.0 to 9.1) and with vaccine serotype-confirmed pneumonia was 2.9 (.5-7.8).
CONCLUSIONS
While there is substantial uncertainty around individual point estimates, there is a consistent trend in VPDI ratios, most commonly showing under-ascertainment of 1.5- to 4-fold, indicating that use of clinically defined outcomes is likely to provide a more accurate estimate of a pneumococcal conjugate vaccine's public health value.
Topics: Adult; Child; Humans; Incidence; Infant; Pneumococcal Infections; Pneumococcal Vaccines; Randomized Controlled Trials as Topic; Vaccine Efficacy; Vaccine-Preventable Diseases; Vaccines, Conjugate
PubMed: 34313721
DOI: 10.1093/cid/ciab649