-
Vaccine May 2017To describe and systematically review the modelling and reporting of cost-effectiveness analysis of vaccination in Hong Kong, and to identify areas for quality... (Review)
Review
OBJECTIVES
To describe and systematically review the modelling and reporting of cost-effectiveness analysis of vaccination in Hong Kong, and to identify areas for quality enhancement in future cost-effectiveness analyses.
METHODS
We conducted a comprehensive and systematic review of cost-effectiveness studies related to vaccination and government immunisation programmes in Hong Kong published from 1990 to 2015, through database search of Pubmed, Web of Science, Embase, and OVID Medline. Methodological quality of selected studies was assessed using Consolidated Health Economic Evaluation Reporting Standards checklist (CHEERS). Decision making of vaccination was obtained from Scientific Committee on Vaccine Preventable Diseases (SCVPD) and Department of Health in Hong Kong.
RESULTS
Nine eligible studies reporting twelve comparative cost-effectiveness comparisons of vaccination programme for influenza (n=2), pneumococcal disease (n=3), influenza plus pneumococcal disease (n=1), chickenpox (n=2), Haemophilus influenzae b (n=1), hepatitis A (n=1), cervical cancer (n=1) and rotavirus (n=1) were identified. Ten comparisons (83.3%) calculated the incremental cost-effectiveness ratio (ICER) of a vaccination strategy versus status quo as outcomes in terms of cost in USD per life-years, cost per quality-adjusted life-years, or cost per disability-adjusted life-years. Among those 10 comparisons in base-case scenario, 4 evaluated interventions were cost-saving relative to status quo while the ICER estimates in 3 of the 6 remaining comparisons were far below commonly accepted threshold and WHO willingness-to-pay threshold, suggestive of very cost-effective. Seven studies were of good quality based on the CHEERS checklist; one was of moderate quality; and one was of excellent quality. The common methodological problems were characterisation of heterogeneity and reporting of study parameters.
CONCLUSIONS
There was a paucity of cost-effectiveness models evaluating vaccination targeted to the Hong Kong population. All evaluated vaccinations and immunisation interventions in Hong Kong, except for Haemophilus influenzae b, hepatitis A and HPV vaccinations, were considered either cost-saving or very cost-effective when compared to status quo.
Topics: Adolescent; Aged; Child; Child, Preschool; Clinical Decision-Making; Cost-Benefit Analysis; Female; Hepatitis A; Hong Kong; Humans; Immunization Programs; Infant; Influenza Vaccines; Influenza, Human; Male; Papillomavirus Vaccines; Pneumococcal Infections; Quality-Adjusted Life Years; Uterine Cervical Neoplasms; Vaccination; Viral Hepatitis Vaccines
PubMed: 28476628
DOI: 10.1016/j.vaccine.2017.04.050 -
EClinicalMedicine Mar 2024Human Immunodeficiency Virus (HIV)-exposed uninfected (HEU) infants have a higher burden of infectious diseases related morbidity and mortality compared with...
BACKGROUND
Human Immunodeficiency Virus (HIV)-exposed uninfected (HEU) infants have a higher burden of infectious diseases related morbidity and mortality compared with HIV-unexposed uninfected (HUU). Immunization of pregnant women living with HIV (PWLWH) could reduce the severity and burden of infectious diseases for HEU in early infancy.
METHODS
We conducted a systematic review of safety and immunogenicity of vaccines administered to PWLWH and meta-analyses to test the overall effect of immunogenicity comparing pregnant women without HIV (PWWH) to PWLWH. We searched MEDLINE, Embase, Web of Science, Virtual Health Library and Cochrane databases in accordance with PRISMA guidelines for randomized controlled trials and observational studies. Review articles, case series, conference abstracts, and animal studies were excluded. Studies were included from inception to 6th September 2023, with no language restrictions. Random effects meta-analyses were performed for immunogenicity using Review manager (RevMan) analysis software version 5.4.1, Geometric Mean Titer (GMT) values were transformed to obtain the mean and standard deviation within RevMan, the effect size was computed and reported as mean difference with respective 95% confidence intervals. The review was registered with PROSPERO CRD42021289081.
FINDINGS
We included 12 articles, comprising 3744 pregnant women, 1714 were PWLWH given either influenza, pneumococcal or an investigational Group B (GBS) vaccine. Five studies described safety outcomes, and no increase in adverse events was reported in PWLWH compared to PWWH. The GMT increase from baseline to 28-35 weeks post vaccination in HA units ranged from 12.4 (95% CI: 9.84-14.9) to 238.8 (95% CI: 0.35-477.9). Meta-analyses of influenza vaccines showed the pooled geometric mean difference in Hemagglutination Inhibition (HAI) titers post vaccination was 56.01 (95% CI: 45.01-67.01), p < 0.001. The increase was less in PWLWH when compared with PWWH: -141.76 (95% CI: -194.96, -88.55), p < 0.001.
INTERPRETATION
There are limited data on the safety and immunogenicity of vaccines given to PWLWH making policy consideration in this group difficult when new vaccines are introduced. With new vaccines on the horizon, PWLWH need to be included in studies to promote vaccine confidence for this special population.
FUNDING
This work was funded by Medical Research Council Joint Clinical Trials Round 9 [MR/T004983/1].
PubMed: 38333366
DOI: 10.1016/j.eclinm.2024.102448 -
The Journal of Infection Oct 2020Colonisation with Streptococcus pneumoniae can lead to invasive pneumococcal disease and pneumonia. Pneumococcal acquisition and prevalence of colonisation are high in... (Meta-Analysis)
Meta-Analysis
Upper airways colonisation of Streptococcus pneumoniae in adults aged 60 years and older: A systematic review of prevalence and individual participant data meta-analysis of risk factors.
BACKGROUND
Colonisation with Streptococcus pneumoniae can lead to invasive pneumococcal disease and pneumonia. Pneumococcal acquisition and prevalence of colonisation are high in children. In older adults, a population susceptible to pneumococcal disease, colonisation prevalence is reported to be lower, but studies are heterogeneous.
METHODS
This is a systematic review and meta-analysis of prevalence of, and risk factors for, pneumococcal colonisation in adults ≥ 60 years of age (PROSPERO #42016036891). We identified peer-reviewed studies reporting the prevalence of S. pneumoniae colonisation using MEDLINE and EMBASE (until April 2016), excluding studies of acute disease. Participant-level data on risk factors were sought from each study.
FINDINGS
Of 2202 studies screened, 29 were analysable: 18 provided participant-level data (representing 6290 participants). Prevalence of detected pneumococcal colonisation was 0-39% by conventional culture methods and 3-23% by molecular methods. In a multivariate analysis, colonisation was higher in persons from nursing facilities compared with the community (odds ratio (OR) 2•30, 95% CI 1•26-4•21 and OR 7•72, 95% CI 1•15-51•85, respectively), in those who were currently smoking (OR 1•69, 95% CI 1•12-2•53) or those who had regular contact with children (OR 1•93, 95%CI 1•27-2•93). Persons living in urban areas had significantly lower carriage prevalence (OR 0•43, 95%CI 0•27-0•70).
INTERPRETATION
Overall prevalence of pneumococcal colonisation in older adults was higher than expected but varied by risk factors. Future studies should further explore risk factors for colonisation, to highlight targets for focussed intervention such as pneumococcal vaccination of high-risk groups.
FUNDING
No funding was required.
Topics: Aged; Carrier State; Child; Humans; Middle Aged; Nasopharynx; Pneumococcal Infections; Pneumococcal Vaccines; Prevalence; Risk Factors; Streptococcus pneumoniae
PubMed: 32562794
DOI: 10.1016/j.jinf.2020.06.028 -
Journal of the International AIDS... Jan 2020HIV-associated cryptococcal, TB and pneumococcal meningitis are the leading causes of adult meningitis in sub-Saharan Africa (SSA). We performed a systematic review and... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
HIV-associated cryptococcal, TB and pneumococcal meningitis are the leading causes of adult meningitis in sub-Saharan Africa (SSA). We performed a systematic review and meta-analysis with the primary aim of estimating mortality from major causes of adult meningitis in routine care settings, and to contrast this with outcomes from clinical trial settings.
METHODS
We searched PubMed, EMBASE and the Cochrane Library for published clinical trials (defined as randomized-controlled trials (RCTs) or investigator-managed prospective cohorts) and observational studies that evaluated outcomes of adult meningitis in SSA from 1 January 1990 through 15 September 2019. We performed random effects modelling to estimate pooled mortality, both in clinical trial and routine care settings. Outcomes were stratified as short-term (in-hospital or two weeks), medium-term (up to 10 weeks) and long-term (up to six months).
RESULTS AND DISCUSSION
Seventy-nine studies met inclusion criteria. In routine care settings, pooled short-term mortality from cryptococcal meningitis was 44% (95% confidence interval (95% CI):39% to 49%, 40 studies), which did not differ between amphotericin (either alone or with fluconazole) and fluconazole-based induction regimens, and was twofold higher than pooled mortality in clinical trials using amphotericin based treatment (21% (95% CI:17% to 25%), 17 studies). Pooled short-term mortality of TB meningitis was 46% (95% CI: 33% to 59%, 11 studies, all routine care). For pneumococcal meningitis, pooled short-term mortality was 54% in routine care settings (95% CI:44% to 64%, nine studies), with similar mortality reported in two included randomized-controlled trials. Few studies evaluated long-term outcomes.
CONCLUSIONS
Mortality rates from HIV-associated meningitis in SSA are very high under routine care conditions. Better strategies are needed to reduce mortality from HIV-associated meningitis in the region.
Topics: Adult; Africa South of the Sahara; Aged; Amphotericin B; Antifungal Agents; Female; Fluconazole; HIV Infections; Humans; Male; Meningitis, Cryptococcal; Middle Aged; Prospective Studies; Randomized Controlled Trials as Topic
PubMed: 31957332
DOI: 10.1002/jia2.25416 -
Autoimmunity Reviews Jan 2019The immunological perturbations associated with systemic lupus erythematosus (SLE) put many patients at a higher risk of infections, including pneumococcal pneumonia.... (Meta-Analysis)
Meta-Analysis
Immunogenicity, safety and tolerability of anti-pneumococcal vaccination in systemic lupus erythematosus patients: An evidence-informed and PRISMA compliant systematic review and meta-analysis.
The immunological perturbations associated with systemic lupus erythematosus (SLE) put many patients at a higher risk of infections, including pneumococcal pneumonia. However, the uptake and utility of anti-pneumococcal vaccines in SLE patient is both controversial and not completely agreed upon. Indeed, several epidemiological studies of anti-pneumococcal vaccine safety and efficacy in SLE have reported short-term immunogenicity with elevated anti-pneumococcal antibody titres but inconsistent long-term findings, with some studies finding poor responses, mainly for long-term immune protection. Moreover, the safety and efficacy of the pneumococcal vaccine in SLE patients remains controversial due to the different types of anti-pneumococcal vaccines, and the heterogeneity of SLE patients. Several reviews addressing anti-pneumococcal vaccination in SLE patients exist, however, to the best of our knowledge, the present is the first systematic review and meta-analysis. To better understand the efficacy and safety of pneumococcal vaccination in SLE, a comprehensive literature search was performed identifying 18 studies, which have been included in the present systematic review and meta-analysis. All studies were designed as longitudinal investigations, 2, in particular, were of high quality, being randomized, double-blind trials (RCTs). Four studies had control groups. Total sample size included 601 participants. Vaccine immunogenicity in terms of subjects with protective antibody titers ranged from 36% to 97.6%. According to our systematic review and metanalysis, high erythrocyte sedimentation rate (ESR), older age, earlier SLE onset, high disease activity, and immunosuppressive therapy were predictors of poor immunogenicity, although belimumab was found to have no significant impact. With regard to safety, no serious adverse events were found, with up to one third of cases reporting mild/low-grade complaints. In conclusion, due to the high risk of pneumococcal infection in SLE patients and given the safety and, at least partial, effectiveness, according to our systematic review and meta-analysis, in such patients, preventive strategies mainly by immunization, are required in all age groups and, in those needing immunosuppressive therapy, immunization should be given prior the initiation of the treatment. PROSPERO registration code CRD42018103605.
Topics: Humans; Lupus Erythematosus, Systemic; Pneumococcal Vaccines
PubMed: 30408581
DOI: 10.1016/j.autrev.2018.08.002 -
Clinical Medicine Insights.... 2019is one of the primary cause of community-acquired pneumonia (CAP) worldwide. However, scant data are available on the prevalence of etiological organisms for CAP in...
BACKGROUND
is one of the primary cause of community-acquired pneumonia (CAP) worldwide. However, scant data are available on the prevalence of etiological organisms for CAP in adolescent and adult Indian population.
OBJECTIVE
We performed a systematic review and meta-analysis to determine the contribution of in the causation of CAP in Indian patients aged 12 years or above.
METHODOLOGY
We performed a systematic search of both indexed and non-indexed publications using PubMed, databases of National Institute of Science Communication and Information Resources (NISCAIR), Annotated Bibliography of Indian Medicine (ABIM), Google Scholar, and hand search including cross-references using key terms 'community acquired pneumonia AND India'. All studies, published between January 1990 and January 2017, that evaluated Indian patients aged above 12 years with a confirmed diagnosis of CAP were eligible for inclusion. Our search retrieved a total of 182 studies, of which only 17 and 12 qualified for inclusion in the systematic review of all etiological organisms, and meta-analysis of , respectively.
RESULTS
A total of 1435 patients met the inclusion criteria. The pooled proportion of patients with infection was 19% (95% confidence interval [CI]: 12%-26%; I = 94.5% where I represents heterogeneity, < .01). Other major etiological agents are (15.5% [1.1%-35.5%]), (10.5% [1.6%-24.0%]), and (7.3% [2.5%-23.8%]).
CONCLUSIONS
Analysis found approximately a one-fifth proportion of adult Indian patients of CAP with infection, suggesting it as a leading organism for causing CAP compared with other etiological organisms.
PubMed: 31391784
DOI: 10.1177/1179548419862790 -
BMC Infectious Diseases Aug 2019HIV-infected children are at a higher risk of Invasive Pneumococcal Disease (IPD) and its mortality, even in the era of antiretroviral therapy. Therefore, an effective... (Meta-Analysis)
Meta-Analysis
Effectiveness of pneumococcal conjugate vaccination against invasive pneumococcal disease among children with and those without HIV infection: a systematic review and meta-analysis.
BACKGROUND
HIV-infected children are at a higher risk of Invasive Pneumococcal Disease (IPD) and its mortality, even in the era of antiretroviral therapy. Therefore, an effective vaccination strategy would be beneficial. To investigate the effectiveness of Pneumococcal Conjugate Vaccination (PCV) against IPD among HIV-Infected and HIV-Uninfected Children through a systematic review and meta-analysis.
METHODS
Observational studies and randomized trials on 7 years old or older children were searched in the Cochrane Library, Web of Science core collection, Embase, Medline/PubMed, and Google Scholar. Critical appraisal was done using the Cochrane risk of bias tool and the Newcastle-Ottawa quality assessment form. Effectiveness and efficacy of at least one dose of PCV was investigated among children with and without HIV considering subgroups of pneumococcal serotypes. We meta-analyzed the effect sizes using random-effects modeling.
RESULTS
Efficacy of PCV was estimated as 45.0% (31.2, 56.1) and 52.6% (25.7, 69.8) among HIV-infected and HIV-uninfected children, respectively. Effectiveness of PCV among HIV-infected children as - 6.2% (- 67.6, 32.7) was significantly lower than HIV-uninfected children 65.1% (47.3, 76.9). Effectiveness of PCV among HIV-infected children for IPDs caused by vaccine serotypes was estimated as 7.7(- 66.7, 48.9), and for IPDs caused by non-vaccine serotypes was estimated as - 402.8(- 1856, - 29.2).
CONCLUSION
Unlike the evidence on the efficacy of PCV against IPD among both of HIV-infected and HIV-uninfected children, its effectiveness against IPD among HIV-infected children is much less limited.
REVIEW REGISTRATION
The study protocol was registered at PROSPERO (registration ID: CRD42018108187).
Topics: AIDS-Related Opportunistic Infections; Child; Child, Preschool; Humans; Infant; Observational Studies as Topic; Pneumococcal Infections; Pneumococcal Vaccines; Randomized Controlled Trials as Topic; Vaccination; Vaccines, Conjugate
PubMed: 31382917
DOI: 10.1186/s12879-019-4325-4 -
The Cochrane Database of Systematic... May 2022Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable health condition. COPD is associated with substantial burden on morbidity, mortality... (Review)
Review
BACKGROUND
Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable health condition. COPD is associated with substantial burden on morbidity, mortality and healthcare resources.
OBJECTIVES
To review existing evidence for educational interventions delivered to health professionals managing COPD in the primary care setting.
SEARCH METHODS
We searched the Cochrane Airways Trials Register from inception to May 2021. The Register includes records from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Allied and Complementary Medicine Database (AMED) and PsycINFO. We also searched online trial registries and reference lists of included studies.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) and cluster-RCTs. Eligible studies tested educational interventions aimed at any health professionals involved in the management of COPD in primary care. Educational interventions were defined as interventions aimed at upskilling, improving or refreshing existing knowledge of health professionals in the diagnosis and management of COPD.
DATA COLLECTION AND ANALYSIS
Two review authors independently reviewed abstracts and full texts of eligible studies, extracted data and assessed the risk of bias of included studies. We conducted meta-analyses where possible and used random-effects models to yield summary estimates of effect (mean differences (MDs) with 95% confidence intervals (CIs)). We performed narrative synthesis when meta-analysis was not possible. We assessed the overall certainty of evidence for each outcome using Grades of Recommendation, Assessment, Development and Evaluation (GRADE). Primary outcomes were: 1) proportion of COPD diagnoses confirmed with spirometry; 2) proportion of patients with COPD referred to, participating in or completing pulmonary rehabilitation; and 3) proportion of patients with COPD prescribed respiratory medication consistent with guideline recommendations.
MAIN RESULTS
We identified 38 studies(22 cluster-RCTs and 16 RCTs) involving 4936 health professionals (reported in 19/38 studies) and 71,085 patient participants (reported in 25/38 studies). Thirty-six included studies evaluated interventions versus usual care; seven studies also reported a comparison between two or more interventions as part of a three- to five-arm RCT design. A range of simple to complex interventions were used across the studies, with common intervention features including education provided to health professionals via training sessions, workshops or online modules (31 studies), provision of practice support tools, tool kits and/or algorithms (10 studies), provision of guidelines (nine studies) and training on spirometry (five studies). Health professionals targeted by the interventions were most commonly general practitioners alone (20 studies) or in combination with nurses or allied health professionals (eight studies), and the majority of studies were conducted in general practice clinics. We identified performance bias as high risk for 33 studies. We also noted risk of selection, detection, attrition and reporting biases, although to a varying extent across studies. The evidence of efficacy was equivocal for all the three primary endpoints evaluated: 1) proportion of COPD diagnoses confirmed with spirometry (of the four studies that reported this outcome, two supported the intervention); 2) proportion of patients with COPD who are referred to, participate in or complete pulmonary rehabilitation (of the four studies that reported this outcome, two supported the intervention); and 3) proportion of patients with COPD prescribed respiratory medications consistent with guideline recommendations (12 studies reported this outcome, the majority evaluated multiple drug classes and reported a mixed effect). Additionally, the low quality of evidence and potential risk of bias make the interpretation more difficult. Moderate-quality evidence (downgraded due to risk of bias concerns) suggests that educational interventions for health professionals probably improve the proportion of patients with COPD vaccinated against influenza (three studies) and probably have little impact on the proportion of patients vaccinated against pneumococcal infection (two studies). Low-quality evidence suggests that educational interventions for health professionals may have little or no impact on the frequency of COPD exacerbations (10 studies). There was a high degree of heterogeneity in the reporting of health-related quality of life (HRQoL). Low-quality evidence suggests that educational interventions for health professionals may have little or no impact on HRQoL overall, and when using the COPD-specific HRQoL instrument, the St George's Respiratory Questionnaire (at six months MD 0.87, 95% CI -2.51 to 4.26; 2 studies, 406 participants, and at 12 months MD -0.43, 95% CI -1.52 to 0.67, 4 studies, 1646 participants; reduction in score indicates better health). Moderate-quality evidence suggests that educational interventions for health professionals may improve patient satisfaction with care (one study). We identified no studies that reported adverse outcomes.
AUTHORS' CONCLUSIONS
The evidence of efficacy was equivocal for educational interventions for health professionals in primary care on the proportion of COPD diagnoses confirmed with spirometry, the proportion of patients with COPD who participate in pulmonary rehabilitation, and the proportion of patients prescribed guideline-recommended COPD respiratory medications. Educational interventions for health professionals may improve influenza vaccination rates among patients with COPD and patient satisfaction with care. The quality of evidence for most outcomes was low or very low due to heterogeneity and methodological limitations of the studies included in the review, which means that there is uncertainty about the benefits of any currently published educational interventions for healthcare professionals to improve COPD management in primary care. Further well-designed RCTs are needed to investigate the effects of educational interventions delivered to health professionals managing COPD in the primary care setting.
Topics: Humans; Influenza, Human; Patient Satisfaction; Primary Health Care; Pulmonary Disease, Chronic Obstructive; Quality of Life; Randomized Controlled Trials as Topic
PubMed: 35514131
DOI: 10.1002/14651858.CD012652.pub2 -
Human Vaccines & Immunotherapeutics Jun 2018Thirteen-valent pneumococcal conjugate vaccines (PCV13) was licensed for optional use in mainland China since 2017, but the uptake is low. To update the research... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Thirteen-valent pneumococcal conjugate vaccines (PCV13) was licensed for optional use in mainland China since 2017, but the uptake is low. To update the research evidence for the pneumococcal serotype distribution of pre-PCV era and to estimate the potential impact of PCVs, we performed a meta-analysis on the relevant publications concerning the Chinese population.
METHODS
This systematic review and meta-analysis were conducted on the pneumococcal serotype distribution publications in mainland China from 2000 to 2016. The literature was searched in PubMed, Ovid-EMBASE, Web of Science, CNKI and Wanfang. Heterogeneity and publication bias were tested by I, meta-regression, Egger's and Begg's test. The pneumococcal serotype and vaccine serotype coverage rates were pooled using the random-effects model in Stata SE 12.0.
RESULTS
In total, 85 publications were included. Of all 16,945 included pneumococcal isolates, the most common serotypes/serogroups were 19F, 19A, 23F, 14, and 6B, that from children were the same as above, that from adults≥18 years were 19, 3, 6, 23, and 14. Among isolates from children <18 years, the pooled coverage for PCV10 serotypes was 52.3%, that for PCV13 was 68.4% and that for PPSV23 was 65.5%. Regarding individuals ≥18 years, the pooled coverage for PCV10 serotypes was 29.7%, that for PCV13 was 49.5% and that for PPSV23 was 50.7%. Serotype prevalence and vaccine serotype coverage varied by age group, source, and region.
CONCLUSIONS
The most common pneumococcal serotype in mainland China was 19F. The serotype coverage rates of PCV13 and PPSV23 were 50%-68% in mainland China.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Child; Child, Preschool; China; Female; Humans; Infant; Infant, Newborn; Male; Middle Aged; Pneumococcal Infections; Pneumococcal Vaccines; Prevalence; Serogroup; Streptococcus pneumoniae; Vaccines, Conjugate; Young Adult
PubMed: 29451838
DOI: 10.1080/21645515.2018.1435224 -
The Cochrane Database of Systematic... Jun 2016Otitis media with effusion (OME) is characterised by an accumulation of fluid in the middle ear behind an intact tympanic membrane, without the symptoms or signs of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Otitis media with effusion (OME) is characterised by an accumulation of fluid in the middle ear behind an intact tympanic membrane, without the symptoms or signs of acute infection. Since most cases of OME will resolve spontaneously, only children with persistent middle ear effusion and associated hearing loss potentially require treatment. Previous Cochrane reviews have focused on the effectiveness of ventilation tube insertion, adenoidectomy, nasal autoinflation, antihistamines, decongestants and corticosteroids in OME. This review, focusing on the effectiveness of antibiotics in children with OME, is an update of a Cochrane review published in 2012.
OBJECTIVES
To assess the benefits and harms of oral antibiotics in children up to 18 years with OME.
SEARCH METHODS
The Cochrane ENT Information Specialist searched the ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2016, Issue 3); PubMed; Ovid EMBASE; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 14 April 2016.
SELECTION CRITERIA
Randomised controlled trials comparing oral antibiotics with placebo, no treatment or therapy of unproven effectiveness in children with OME.
DATA COLLECTION AND ANALYSIS
We used the standard methodological procedures expected by Cochrane.
MAIN RESULTS
Twenty-five trials (3663 children) were eligible for inclusion. Two trials did not report on any of the outcomes of interest, leaving 23 trials (3258 children) covering a range of antibiotics, participants, outcome measures and time points for evaluation. Overall, we assessed most studies as being at low to moderate risk of bias.We found moderate quality evidence (six trials including 484 children) that children treated with oral antibiotics are more likely to have complete resolution at two to three months post-randomisation (primary outcome) than those allocated to the control treatment (risk ratio (RR) 2.00, 95% confidence interval (CI) 1.58 to 2.53; number needed to treat to benefit (NNTB) 5). However, there is evidence (albeit of low quality; five trials, 742 children) indicating that children treated with oral antibiotics are more likely to experience diarrhoea, vomiting or skin rash (primary outcome) than those allocated to control treatment (RR 2.15, 95% CI 1.29 to 3.60; number needed to treat to harm (NNTH) 20).In respect of the secondary outcome of complete resolution at any time point, we found low to moderate quality evidence from five meta-analyses, including between two and 14 trials, of a beneficial effect of antibiotics, with a NNTB ranging from 3 to 7. Time periods ranged from 10 to 14 days to six months.In terms of other secondary outcomes, only two trials (849 children) reported on hearing levels at two to four weeks and found conflicting results. None of the trials reported data on speech, language and cognitive development or quality of life. Low quality evidence did not show that oral antibiotics were associated with a decrease in the rate of ventilation tube insertion (two trials, 121 children) or in tympanic membrane sequelae (one trial, 103 children), while low quality evidence indicated that children treated with antibiotics were less likely to have acute otitis media episodes within four to eight weeks (five trials, 1086 children; NNTB 18) and within six months post-randomisation (two trials, 199 children; NNTB 5). It should, however, be noted that the beneficial effect of oral antibiotics on acute otitis media episodes within four to eight weeks was no longer significant when we excluded studies with high risk of bias.
AUTHORS' CONCLUSIONS
This review presents evidence of both benefits and harms associated with the use of oral antibiotics to treat children up to 16 years with OME. Although evidence indicates that oral antibiotics are associated with an increased chance of complete resolution of OME at various time points, we also found evidence that these children are more likely to experience diarrhoea, vomiting or skin rash. The impact of antibiotics on short-term hearing is uncertain and low quality evidence did not show that oral antibiotics were associated with fewer ventilation tube insertions. Furthermore, we found no data on the impact of antibiotics on other important outcomes such as speech, language and cognitive development or quality of life.Even in situations where clear and relevant benefits of oral antibiotics have been demonstrated, these must always be carefully balanced against adverse effects and the emergence of bacterial resistance. This has specifically been linked to the widespread use of antibiotics for common conditions such as otitis media.
Topics: Adolescent; Anti-Bacterial Agents; Bacterial Infections; Child; Child, Preschool; Hearing Loss; Humans; Infant; Otitis Media with Effusion; Randomized Controlled Trials as Topic; Time Factors; Treatment Outcome
PubMed: 27290722
DOI: 10.1002/14651858.CD009163.pub3