scholarly journals A Systematic Review of Studies Published between 2016 and 2019 on the Effectiveness and Efficacy of Pneumococcal Vaccination on Pneumonia and Invasive Pneumococcal Disease in an Elderly Population

Pathogens ◽  
2020 ◽  
Vol 9 (4) ◽  
pp. 259 ◽  
Author(s):  
Jacob Dag Berild ◽  
Brita Askeland Winje ◽  
Didrik Frimann Vestrheim ◽  
Hans-Christian Slotved ◽  
Palle Valentiner-Branth ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Invasive Pneumococcal Disease ◽  
Vaccine Efficacy ◽  
Observational Studies ◽  
Pneumococcal Disease ◽  
Elderly Population ◽  
Randomized Clinical Trials ◽  
Pneumococcal Vaccination ◽  
Risk Of Bias ◽  
Vaccine Type

Adult vaccination is high on the agenda in many countries. Two different vaccines are available for the prevention of pneumococcal disease in adults: a 23-valent polysaccharide vaccine (PPV23), and a 13-valent conjugated vaccine (PCV13). The objective of this review is to update the evidence base for vaccine efficacy and effectiveness of PPV23 and PCV13 against invasive pneumococcal disease and pneumonia among an unselected elderly population. We systematically searched for clinical trials and observational studies published between January 1 2016 and April 17 2019 in Pubmed, Embase, Cinahl, Web of Science, Epistemonikos and Cochrane databases. Risk of bias was assessed using Cochrane Risk of Bias tool for and the Newcastle–Ottawa Scale. Results were stratified by vaccine type and outcome. We identified nine studies on PCV13 and six on PPV23. No new randomized clinical trials were identified. Due to different outcomes, it was not possible to do a meta-analysis. New high-quality observational studies indicate protective vaccine effectiveness for both vaccines against vaccine type pneumonia. Our estimates for the protective vaccine efficacy and effectiveness (VE) of PPV23 on pneumonia and pneumococcal pneumonia overlap with results from previously published reviews. Some of the results indicate that the effectiveness of the PPV23 is best in younger age groups, and that it decreases over time.

scholarly journals 21. Systematic Review and Meta-Analysis of Pneumococcal Vaccine Effectiveness against Invasive Pneumococcal Disease among Adults

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S134-S135
Author(s):  
Jennifer Loo Farrar ◽  
Miwako Kobayashi ◽  
Lana Childs ◽  
Tamara Pilishvili
Keyword(s):  
Systematic Review ◽  
Invasive Pneumococcal Disease ◽  
Pneumococcal Vaccine ◽  
Observational Studies ◽  
Pneumococcal Disease ◽  
English Literature ◽  
Meta Analysis ◽  
Vaccine Effectiveness ◽  
Vaccine Type ◽  
Effectiveness Studies

Abstract Background Two new pneumococcal conjugate vaccines (PCVs), PCV15 and PCV20, are anticipated to be licensed for use in U.S. adults in 2021. To help inform the U.S. Advisory Committee on Immunization Practices’ discussions on pneumococcal vaccine use among adults, we conducted a systematic review and meta-analysis. We specifically looked at efficacy or effectiveness of PCV13 and pneumococcal polysaccharide vaccine (PPSV23) against invasive pneumococcal disease (IPD) in adults. Methods We conducted a search of English literature published from 1998 – February 2021 on PCV13 and PPSV23 efficacy or effectiveness studies using eight major databases. Studies targeting adults with immunocompromising conditions were excluded. Title and abstract screening of identified studies and data abstraction were performed by two reviewers. Results were stratified by vaccine product, outcome evaluated (vaccine type (VT) or all IPD), study design, and effect measure. Random effects models were used to pool estimates by stratum. Results Of 3,422 citations reviewed, we identified 26 IPD studies; 4 on PCV13, 22 on PPSV23, 18 with all IPD, and 17 with VT-IPD (Table) as an outcome. Only one randomized-controlled trial (RCT) was identified for PCV13 with an efficacy of 52% (95% CI: 22%, 77%) against all IPD and 75% (95% CI: 41%, 91%) against VT-IPD. A pooled vaccine effectiveness (VE) estimate from three observational studies evaluating PCV13 was 56% (95% CI: 32%, 71%; I2 =12.8) against VT-IPD. Two RCTs evaluating PPSV23 reported efficacies against all IPD ranging between 79-86%; an additional RCT reported no IPD cases during RCT. Vaccine effectiveness estimates from 14 observational studies evaluating PPSV23 ranged between 29-76% against all IPD. Pooled VE estimates from 12 observational studies showed PPSV23 effectiveness against VT-IPD was 38% (95% CI: 28% to 46%; I2 =40.8). Table. Efficacy and effectiveness studies against vaccine-type invasive pneumococcal disease Conclusion Evidence suggests both pneumococcal vaccines are effective against VT-IPD in adults. Given that PCV15 and PCV20 are expected to be licensed based on immunogenicity data and no clinical efficacy data are available for these new vaccines, the findings from this review will help inform policy discussions on use of the new PCVs among adults. Disclosures All Authors: No reported disclosures

Can We Trust Observational Studies Using Propensity Scores in the Critical Care Literature? A Systematic Comparison With Randomized Clinical Trials*

2015 ◽  
Vol 43 (9) ◽  
pp. 1870-1879 ◽  
Author(s):  
Georgios D. Kitsios ◽  
Issa J. Dahabreh ◽  
Sean Callahan ◽  
Jessica K. Paulus ◽  
Anthony C. Campagna ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Critical Care ◽  
Observational Studies ◽  
Propensity Scores ◽  
Randomized Clinical Trials ◽  
Systematic Comparison

scholarly journals Coeliac disease and invasive pneumococcal disease: a population-based cohort study

2017 ◽  
Vol 145 (6) ◽  
pp. 1203-1209 ◽  
Author(s):  
A. RÖCKERT TJERNBERG ◽  
J. BONNEDAHL ◽  
M. INGHAMMAR ◽  
A. EGESTEN ◽  
G. KAHLMETER ◽  
...  
Keyword(s):  
Cohort Study ◽  
Coeliac Disease ◽  
Invasive Pneumococcal Disease ◽  
Pneumococcal Disease ◽  
Cox Regression ◽  
Statistical Significance ◽  
Pneumococcal Vaccination ◽  
Population Based ◽  
Increased Risk ◽  
Severe Infections

SUMMARYSevere infections are recognized complications of coeliac disease (CD). In the present study we aimed to examine whether individuals with CD are at increased risk of invasive pneumococcal disease (IPD). To do so, we performed a population-based cohort study including 29 012 individuals with biopsy-proven CD identified through biopsy reports from all pathology departments in Sweden. Each individual with CD was matched with up to five controls (n = 144 257). IPD events were identified through regional and national microbiological databases, including the National Surveillance System for Infectious Diseases. We used Cox regression analyses to estimate hazard ratios (HRs) for diagnosed IPD. A total of 207 individuals had a record of IPD whereas 45/29 012 had CD (0·15%) and 162/144 257 were controls (0·11%). This corresponded to a 46% increased risk for IPD [HR 1·46, 95% confidence interval (CI) 1·05–2·03]. The risk estimate was similar after adjustment for socioeconomic status, educational level and comorbidities, but then failed to attain statistical significance (adjusted HR 1·40, 95% CI 0·99–1·97). Nonetheless, our study shows a trend towards an increased risk for IPD in CD patients. The findings support results seen in earlier research and taking that into consideration individuals with CD may be considered for pneumococcal vaccination.

Dexamethasone in Patients with Spontaneous Intracerebral Hemorrhage: An Updated Meta-Analysis

2020 ◽  
Vol 49 (5) ◽  
pp. 495-502
Author(s):  
Stephanie Wintzer ◽  
Josef Georg Heckmann ◽  
Hagen B. Huttner ◽  
Stefan Schwab
Keyword(s):  
Clinical Trials ◽  
High Risk ◽  
Intracerebral Hemorrhage ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Spontaneous Intracerebral Hemorrhage ◽  
Control Groups ◽  
Language Data ◽  
Negative Effect

<b><i>Background:</i></b> Spontaneous intracerebral hemorrhage (ICH) is a frequent cerebrovascular disorder and still associated with high mortality and poor clinical outcomes. The purpose of this review was to update a 15-year-old former meta-analysis on randomized clinical trials (RCTs) addressing the question of whether ICH patients treated with dexamethasone have better outcomes than controls. <b><i>Methods:</i></b> The electronic databases PubMed, SCOPUS, and Cochrane as well as web platforms on current clinical trials were searched for the years 1970–2020 without constriction on language. Data were extracted and outcomes were pooled for conventional and cumulative meta-analysis using a commercial software program (www.Meta-Analysis.com). <b><i>Results:</i></b> Finally, 7 RCTs were identified and analyzed including 248 participants in the dexamethasone groups and 242 in the control groups. Five studies showed a high risk of bias. The overall relative risk (RR) for death was 1.32 (95% confidence interval [CI] 0.99–1.76; <i>p</i> = 0.06) and did not differ significantly between the 2 groups. After exclusion of studies with high risk of bias, the RR for death was 1.37 (95% CI 0.54–3.42; <i>p</i> = 0.51). The RR for poor outcome did not differ significantly between the 2 groups analyzed for all included studies (RR = 0.69; 95% CI 0.47–1; <i>p</i> = 0.05) and after exclusion of studies with high risk of bias (RR = 0.7; 95% CI 0.45–1.08; <i>p</i> = 0.11). The RR for complications did not differ significantly including all studies (RR = 1.29; 95% CI 0.77–2.17; <i>p</i> = 0.34) and after exclusion of studies with high risk of bias (RR = 1.27; 95% CI 0.18–8.89; <i>p</i> = 0.81). The cumulative statistics delivered no other results; however, it pointed out fewer complications over time in the dexamethasone group. <b><i>Conclusion:</i></b> Clear evidence of a beneficial or negative effect of dexamethasone is still lacking. Modern RCTs or observational studies with propensity design are necessary to evaluate the efficacy and safety of treatment with dexamethasone in patients with ICH.

scholarly journals Photobiomodulation for the Treatment of Primary Headache: Systematic Review of Randomized Clinical Trials

Life ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. 98
Author(s):  
Andréa Oliver Gomes ◽  
Ana Luiza Cabrera Martimbianco ◽  
Aldo Brugnera Junior ◽  
Anna Carolina Ratto Tempestini Horliana ◽  
Tamiris da Silva ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adjuvant Treatment ◽  
Randomized Clinical Trials ◽  
Primary Headache ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Sham Treatment ◽  
Methodological Assessment ◽  
Grade Approach

The purpose of this study was to evaluate the efficacy and safety of photobiomodulation as an adjuvant treatment for primary headache. A systematic review of randomized clinical trials was performed. For such, electronic searches were performed in the MEDLINE, Embase, Cochrane Library, LILACS, PEDro, PsycInfo, Clinicaltrials.gov., and WHO/ICTRP databases, with no restrictions imposed regarding language or year of publication. We included studies that assessed any photobiomodulation therapy as an adjuvant treatment for primary headache compared to sham treatment, no treatment, or another intervention. The methodological assessment was conducted using the Cochrane Risk of Bias tool. The certainty of the evidence was classified using the GRADE approach. Four randomized clinical trials were included. Most of the included studies had an overall high risk of bias. Compared to sham treatment, photobiomodulation had a clinically important effect on pain in individuals with primary headache. Despite the benefits reported for other outcomes, the estimates were imprecise, and the certainty of the evidence was graded as low. These findings are considered insufficient to support the use of photobiomodulation in the treatment of primary headache. Randomized clinical trials, with higher methodological quality, are needed to enhance the reliability of the estimated effects.

scholarly journals Guidelines on how to assess the validity of results presented in subgroup analysis of clinical trials

2002 ◽  
Vol 57 (2) ◽  
pp. 83-88 ◽  
Author(s):  
Edson Duarte Moreira ◽  
Ezra Susser
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Randomized Clinical Trial ◽  
Subgroup Analysis ◽  
Observational Studies ◽  
Randomized Clinical Trials ◽  
Usual Method ◽  
Validity Of Results ◽  
Results Of Treatment ◽  
Trial Participants

In observational studies, identification of associations within particular subgroups is the usual method of investigation. As an exploratory method, it is the bread and butter of epidemiological research. Nearly everything that has been learned in epidemiology has been derived from the analysis of subgroups. In a randomized clinical trial, the entire purpose is the comparison of the test subjects and the controls, and when there is particular interest in the results of treatment in a certain section of trial participants, a subgroup analysis is performed. These subgroups are examined to see if they are liable to a greater benefit or risk from treatment. Thus, analyzing patient subsets is a natural part of the process of improving therapeutic knowledge through clinical trials. Nevertheless, the reliability of subgroup analysis can often be poor because of problems of multiplicity and limitations in the numbers of patients studied. The naive interpretation of the results of such examinations is a cause of great confusion in the therapeutic literature. We emphasize the need for readers to be aware that inferences based on comparisons between subgroups in randomized clinical trials should be approached more cautiously than those based on the main comparison. That is, subgroup analysis results derived from a sound clinical trial are not necessarily valid; one must not jump to conclusions and accept the validity of subgroup analysis results without an appropriate judgment.

scholarly journals Effect of Orthodontic Treatment on Tooth Autotransplantation: Systematic Review of Controlled Clinical Trials

2020 ◽  
Vol 14 (03) ◽  
pp. 467-482
Author(s):  
Rogério Lacerda-Santos ◽  
Rhaíssa Ferreira Canutto ◽  
José Lucas dos Santos Araújo ◽  
Fabiola Galbiatti de Carvalho ◽  
Eliseu Aldrighi Münchow ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Risk Of Bias ◽  
Significant Heterogeneity ◽  
Controlled Clinical Trials ◽  
Periodontal Tissues ◽  
Orthodontic Movement ◽  
Anterior Teeth

AbstractThis systematic review was focused on evaluating tooth autotransplantation, considering its impacts on the teeth, bone, soft tissues, and aesthetics in orthodontic patients. A bibliographic search was conducted without limitations on year of publication or language in the databases of PubMed, Web of Science, Scopus, Medline Complete, Cochrane, Clinical Trials, and Trials Central. For triage of articles, indications, surgical planning, orthodontic movement, risk factors for treatment, and long-term follow-ups were considered. For outcomes, the results with reference to teeth, alveolar bone, periodontal tissues, and esthetic satisfaction were considered. Risk of bias was evaluated using the methodological index for nonrandomized studies-MINORS. The results showed 10 controlled clinical trials, and no randomized clinical trials were found. The selected studies included 715 patients and 934 autotransplanted teeth among which there were premolars, molars, and anterior teeth evaluated in the long term, indicating that orthodontics associated with autotransplantation indicated a result that was generally clinically acceptable. The quality of the set of evidence was considered medium due to the presence of different methodological problems, risk of bias, and significant heterogeneity in the evaluated studies. There was a sufficient body of evidence that justified autotransplantation in patients who needed orthodontic movement. In teeth, there was an increase in root resorption influenced by orthodontics, but without impacting on the general clinical result in the long term. Bone and periodontal tissue do not appear to be affected by orthodontics. The patient’s aesthetic satisfaction was not considered in the studies.

scholarly journals Vaccines to prevent COVID-19: a protocol for a living systematic review with network meta-analysis including individual patient data (The LIVING VACCINE Project)

2020 ◽  
Vol 9 (1) ◽  
Author(s):  
Steven Kwasi Korang ◽  
Sophie Juul ◽  
Emil Eik Nielsen ◽  
Joshua Feinberg ◽  
Faiza Siddiqui ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Individual Patient Data ◽  
Viral Vector ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Serious Adverse Events ◽  
Meta Analyses ◽  
Harmful Effects

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19) which has rapidly spread worldwide. Several human randomized clinical trials assessing potential vaccines are currently underway. There is an urgent need for a living systematic review that continuously assesses the beneficial and harmful effects of all available vaccines for COVID-19. Methods/design We will conduct a living systematic review based on searches of major medical databases (e.g., MEDLINE, EMBASE, CENTRAL) and clinical trial registries from their inception onwards to identify relevant randomized clinical trials. We will update the literature search once a week to continuously assess if new evidence is available. Two review authors will independently extract data and conduct risk of bias assessments. We will include randomized clinical trials comparing any vaccine aiming to prevent COVID-19 (including but not limited to messenger RNA; DNA; non-replicating viral vector; replicating viral vector; inactivated virus; protein subunit; dendritic cell; other vaccines) with any comparator (placebo; “active placebo;” no intervention; standard care; an “active” intervention; another vaccine for COVID-19) for participants in all age groups. Primary outcomes will be all-cause mortality; a diagnosis of COVID-19; and serious adverse events. Secondary outcomes will be quality of life and non-serious adverse events. The living systematic review will include aggregate data meta-analyses, trial sequential analyses, network meta-analyses, and individual patient data meta-analyses. Within-study bias will be assessed using Cochrane risk of bias tool. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) and Confidence in Network Meta-Analysis (CINeMA) approaches will be used to assess certainty of evidence. Observational studies describing harms identified during the search for trials will also be included and described and analyzed separately. Discussion COVID-19 has become a pandemic with substantial mortality. A living systematic review assessing the beneficial and harmful effects of different vaccines is urgently needed. This living systematic review will regularly inform best practice in vaccine prevention and clinical research of this highly prevalent disease. Systematic review registration PROSPERO CRD42020196492

scholarly journals 2701. The Impact of Infant 13-valent Conjugate Pneumococcal Vaccination Program on Invasive Pneumococcal Disease in Children in British Columbia, Canada

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S950-S950
Author(s):  
Nirma K Vadlamudi ◽  
David Patrick ◽  
Linda Hoang ◽  
Fawziah Marra
Keyword(s):  
British Columbia ◽  
Invasive Pneumococcal Disease ◽  
Pneumococcal Disease ◽  
Pneumococcal Vaccination ◽  
Annual Incidence ◽  
Immunization Program ◽  
Incremental Change ◽  
Laboratory Surveillance ◽  
Rate Ratios ◽  
The Impact

Abstract Background A significant reduction in invasive pneumococcal disease (IPD) has been reported following implementation of the 7-valent pneumococcal conjugate vaccine (PCV7) infant immunization program, but not much has been reported after introduction of the 13-valent vaccine (PCV13). This study represents the effect of PCV13 on IPD in British Columbia, Canada over a 14 year period (2002–2015). Methods Using provincial IPD laboratory surveillance data, we calculated the annual incidence following implementation of PCV7 (September 2004), and PCV13 (September 2010) in children less than 17 years of age. We also compared incidence rate ratios (IRR) against pre-PCV13 (2004–2010) and pre-PCV7 (2002–2003) baselines for overall and age-specific IPD rates using Poisson regression. Results A total of 697 cases were reported over the 14 year period. The overall annual incidence decreased from 10.9 cases per 100,000 population in 2002 to 4.64 cases per 100,000 population in 2015. While overall decline of IPD was 59% (IRR 0.41; 95% CI: 0.35–0.51) compared with baseline, this reduction was greatest after introduction of PCV7 (IRR 0.44; 95% CI: 0.37–0.53); the incremental change after introduction of PCV13 was non-significant (IRR 0.94; 95% CI: 0.78–1.13). The greatest reduction in IPD was in children <2 years of age (PCV13 vs baseline: IRR 0.19; 95% CI: 0.14–0.25), followed by children 3–5 years of age (PCV13 vs baseline: IRR 0.34; 95% CI: 0.21–0.56); no significant change was observed in 6–17 year olds. Conclusion While IPD rates have been significantly reduced since the introduction of the PCV vaccines, the impact of the additional 6 serotypes in the PCV13 vaccine is non-significant. Disclosures All authors: No reported disclosures.

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