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19 noviembre, 2021

Metanalisis: uso de mascarilla

Prevención de virus respiratorios con mascarilla N95

Objetivo: Examinar los resultados, el nivel de evidencia y la calidad metodológica de los estudios originales sobre la efectividad de la mascarilla quirúrgica para minimizar la transmisión de enfermedades respiratorias virales y, en particular, el rendimiento del respirador N95 frente a la mascarilla quirúrgica.

Métodos: El metanálisis se realizó de acuerdo con las pautas de Preferred Reporting Items for Systematic Reviews and Meta-Analyzes (PRISMA) con el uso de las bases de datos PubMed, MEDLINE y Cochrane Library.

Resultados: Se incluyeron ocho estudios (9164 participantes) después de seleccionar 153 artículos. Los análisis mostraron diferencias estadísticamente significativas entre el respirador N95 versus el uso de mascarillas quirúrgicas para prevenir:

- enfermedades similares a la influenza (RR = 0,81, intervalo de confianza [IC] del 95% = 0,68-0,94, P <0,05),

- virus respiratorio no influenza infección (RR = 0,62, IC del 95% = 0,52-0,74, P <0,05),

- infección viral respiratoria (RR = 0,73, IC del 95% = 0,65-0,82, P <0,05),

- síndrome respiratorio agudo severo coronavirus (SARS-CoV) 1 y 2 infección por virus (RR = 0,17, IC del 95% = 0,06-0,49, P <0,05) e

- infección viral respiratoria confirmada por laboratorio (RR = 0,75, IC del 95% = 0,66-0,84, P <0,05).

Los análisis no indicaron resultados estadísticamente significativos contra la influenza confirmada por laboratorio (RR = 0,87, IC = 0,74-1,03, P> 0,05).

Conclusiones: El uso del respirador N95 se asoció con menos episodios infecciosos virales para los trabajadores de la salud en comparación con las mascarillas quirúrgicas. El respirador N95 fue más eficaz para reducir el riesgo de una infección viral en el entorno hospitalario por los virus SARS-CoV 1 y 2 en comparación con los otros virus incluidos en esta investigación. La calidad metodológica, el riesgo de sesgos y el pequeño número de estudios originales indican la necesidad de realizar más investigaciones, especialmente en entornos de atención de primera línea.

Referencia

1. Collins AP, Service BC, Gupta S, et al. N95 respirator and surgical mask effectiveness against respiratory viral illnesses in the healthcare setting: A systematic review and meta-analysis. J Am Coll Emerg Physicians Open. 2021 Oct 28;2(5):e12582. doi: 10.1002/emp2.12582. eCollection 2021 Oct. [Texto completo]

09 junio, 2013

The PRISMA Statment for reporting systematic reviews and meta-analyses

PLoS Med. 2009 July; 6(7): e1000100.

Published online 2009 July 21. doi: 10.1371/journal.pmed.1000100

PMCID: PMC2707010

Full Text PDF

In Spanish (Evidencias en Pediatria )

The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration

Alessandro Liberati,^1,^2,^* Douglas G. Altman,³ Jennifer Tetzlaff,⁴ Cynthia Mulrow,⁵ Peter C. Gøtzsche,⁶ John P. A. Ioannidis,⁷ Mike Clarke,^8,⁹ P. J. Devereaux,¹⁰ Jos Kleijnen,^11,¹² and David Moher^4,¹³

Systematic reviews and meta-analyses are essential to summarize evidence relating to efficacy and safety of health care interventions accurately and reliably. The clarity and transparency of these reports, however, is not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, and other users.

Since the development of the QUOROM (QUality Of Reporting Of Meta-analysis) Statement—a reporting guideline published in 1999—there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realizing these issues, an international group that included experienced authors and methodologists developed PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) as an evolution of the original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health care interventions.

The PRISMA Statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review. In this Explanation and Elaboration document, we explain the meaning and rationale for each checklist item. For each item, we include an example of good reporting and, where possible, references to relevant empirical studies and methodological literature. The PRISMA Statement, this document, and the associated Web site (http://www.prisma-statement.org/) should be helpful resources to improve reporting of systematic reviews and meta-analyses.

04 octubre, 2011

Do statins have a role in primary prevention? An update

Submitted by Therapeutics Initiative on Fri, 09/17/2010 - 12:18

Therapeutics Letter

Therapeutics Letter 77: March - April 2010

Click here to download a printable version of this Therapeutics Letter in Adobe Acrobat PDF format (578 KB).

Therapeutics Letter #48 (April-June 2003)¹ concluded that “statins have not been shown to provide an overall health benefit in primary prevention trials” based on the 5 RCTs^8-12 available at that time. More RCTs are now available and 5 systematic reviews^2-6 designed to answer this question have been published since 2003. Unfortunately, these reviews do not answer the question “Do the benefits of statins outweigh the harms in people without proven occlusive vascular disease?” This question is critically important to patients, physicians and health care resource utilization.

The Cochrane Collaboration is regarded as the gold standard of systematic reviews. One of its guiding principles is avoiding unnecessary duplication: any independent reviewer following the proper methodology would include the same trials, extract the same data and come to the same interpretation and conclusions. The review is then updated as new trials are published.

The 5 published systematic reviews^2-6 (none of which are Cochrane reviews) vary in the RCTs included, summary effect estimates, conclusions and declared conflicts of interest of the authors (Table 1).

Table 1. Published systematic reviews

Two of these reviews report a decrease in total mortality while 3, including the latest, conclude that mortality is not decreased by statins in this setting.

What is the explanation for the different relative risk estimates? In part, it is due to the timing of the review and the trials that were available for inclusion. The 2006 review² did not have access to 3 RCTs^17-19. The 2007 review³ did not have access to 2 RCTs^18,19. The 2008 review⁴ did not include 2 RCTs^13,19 and included 10 RCTs^20-29 not included in any of the other reviews. The 2009 and 2010 reviews^5,6 had access to the same RCTs and had very small differences in the RCTs included (Table 1). The reason for the variation in the overall mortality estimate between the 2009 and 2010 reviews is that the 2010 review requested and obtained additional details from authors, allowing exclusion of 3659 secondary prevention patients from 4 large RCTs^8,10,11,12.

Why is a new systematic review necessary?

The differences in the interpretation and conclusions of these non-Cochrane reviews are confusing for clinicians. They can be resolved by using Cochrane methodology, including the Cochrane Risk of Bias Tool. Therefore we performed a new systematic review starting with the 22 RCTs included in at least one of these 5 systematic reviews. We excluded 10 of the RCTs^20-29 included in the 2008 review because the population studied was largely or entirely people with occlusive vascular disease at baseline. We included the remaining 12 RCTs^8-19, which provided data for at least one of 3 outcomes that we judged least subject to bias and most meaningful to patients: total all-cause mortality, total people with at least one serious adverse event (SAE) and total people with at least one major coronary heart disease (CHD) serious adverse event. All-cause mortality is an important outcome, for which we used the more accurate data from the 2010 review. Total SAEs capture overall mortality and all serious morbidity. Major CHD (non-fatal MI and death from coronary heart disease) is the outcome specifically reduced by statins, and less subject to bias than other cardiovascular outcomes such as revascularizations and strokes.

Results. All 12 RCTs report major CHD data, 11 report mortality data and 6 report SAE data. Our meta-analysis demonstrates that the reduction in mortality and major CHD, both SAE outcomes, is not reflected in a reduction in total SAEs (Table 2). The results are similar if they are limited to the 6 RCTs^{8,9,11,14,16,19} that reported SAEs: mortality RR 0.90 [0.79-0.98], ARR 0.4%; Major CHD RR 0.70 [0.62-0.79], ARR 1.0%.
However, getting accurate data entered and analysed is insufficient on its own. Cochrane reviews require assessing the risk of bias for each included RCT using the Risk of Bias Tool. Using this tool we found some risk of bias for each of the 12 included RCTs. Table 2.

Table 2. Statins for primary prevention meta-analysis

*Click here to see the forest plots.

Loss of blinding to treatment allocation probably occurred in all 12 RCTs, because statins predictably lower LDL cholesterol and the physicians managing the patients knew the lipid parameters. This loss of blinding likely biased clinical decisions regarding revascularization procedures and how outcomes were categorized (e.g. transient ischemic attack or reversible ischemic neurological deficit). Fewer revascularization procedures in the statin group as a result of loss of blinding would result in fewer complications secondary to the procedures, e.g. myocardial infarctions.

Other risks of bias affected only some RCTs. Of highest risk are the biases due to stopping RCTs early for benefit, affecting 3 RCTs^12,14,19, and incomplete outcome reporting bias (not an intention to treat analysis), affecting 1 RCT¹⁸. A recent research study demonstrated that the magnitude of the bias effect from stopping RCTs early for benefit is surprisingly large and robust, RR 0.71 [0.66-0.77].⁷ Testing the effect of this bias estimate on the early terminated JUPITER trial changes the RR for major CHD from 0.54 to 0.76 and completely negates the mortality benefit.

In order to test the effect of the bias from these 4 RCTs we removed them; analysis of the remaining 7 RCTs (Table 2, second row) shows no reduction in mortality. This suggests that the claimed mortality benefit with statins for primary prevention is more likely due to bias than being a true effect. Removing the 4 potentially biased trials also diminished the magnitude of the major CHD relative risk reduction from 26% to 21%.

How can CHD SAEs decrease, but not total SAEs?

All CHD events are SAEs and are counted in both categories. Therefore a reduction in major CHD SAEs should be reflected in a reduction in total SAEs. The fact that it is not suggests that other SAEs are increased by statins negating the reduction in CHD SAEs in this population. A limitation of our analysis is that we could not get total SAE data from all the included RCTs. However, we are confident that the data from the 6 missing RCTs would not change the results, because they represent only 41.2% of the total population and include ALLHAT-LLT¹⁰, where one would not expect a reduction in total SAEs; in that trial there was no effect on mortality or cardiovascular SAEs.

Conclusions

Systematic reviews and meta-analyses are challenging and require much more than locating RCTs and plugging in the numbers.
The claimed mortality benefit of statins for primary prevention is more likely a measure of bias than a real effect.
The reduction in major CHD serious adverse events with statins as compared to placebo is not reflected in a reduction in total serious adverse events.
Statins do not have a proven net health benefit in primary prevention populations and thus when used in that setting do not represent good use of scarce health care resources.

*Click here for Appendix: Forest Plots.

The draft of this Therapeutics Letter was submitted for review to 45 experts and primary care physicians in order to correct any inaccuracies and to ensure that the information is concise and relevant to clinicians.

References

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Ray KK, Sreenivasha RKS, Sebhat E, et al. Statins and all-cause mortality in high-risk primary prevention. A meta-analysis of 11 randomized controlled trials involving 65,229 participants. Arch Intern Med. 2010;170(12):1024-1031.
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Sever PS. Dahlof B. Poulter NR. Wedel H. Beevers G. Caulfield M. Collins R. Kjeldsen SE. Kristinsson A. McInnes GT. Mehlsen J. Nieminen M. O'Brien E. Ostergren J. ASCOT investigators. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial--Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial. Lancet. 361(9364):1149-58, 2003 Apr 5.
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Celera Signs Agreement with Abbott for Distribution of CE-marked KIF6 Test to Identify Patients at Risk of Coronary Heart Disease (eon.businesswire.com)
Celera Announces Issuance of United States Patent Relating to KIF6 Gene Variant as a Predictor of Increased Risk of Myocardial Infarction and Reduction of Such Risk Following Statin Therapy (eon.businesswire.com)
Celera Publishes Review Article on the KIF6 Gene Variant as a Predictor of Risk of Coronary Heart Disease (CHD) and Reduction in Coronary Events from Statin Therapy (eon.businesswire.com)
Statins May Guard Against Rheumatoid Arthritis (nlm.nih.gov)
Statins: Evidence of Broader Benefits (time.com)
Study Raises Questions Over Wider Use of Statins (nlm.nih.gov)
Study Revisits Statin Debate: Use for Healthy People? (time.com)
Who Should Take Statins? The Scientific Debate Continues (time.com)
Studies Reignite Debate Over Statin Drugs for Healthy Patients (time.com)
Statins: The answer or false hope? (seattletimes.nwsource.com)
Some on Statins May Not Need Boost in 'Good' Cholesterol (health.usnews.com)
Cryotherapy Or Salicylic Acid Treatment Of Verrucae Equally As Effective (medicalnewstoday.com)
Statins for Primary Prevention: the Debate Continues (forbes.com)
Probiotics Have Slight Preventive Effect On Colds: Review (medicalnewstoday.com)
No strong evidence to support aspirin use for IVF (eurekalert.org)
Despite All the Benefits, Lipid-Lowering Drugs Cause Erectile Dysfunction, a Systematic Review (yuanadesukma.wordpress.com)
Systematic Review of Educational Interventions for Improving Advance Directive Completion (nursetopia.net)
Music Eases Cancer Patients' Anxiety (nlm.nih.gov)
Psychosocial Implications of Living 5 Years or More Following A Cancer Diagnosis (nursetopia.net)
Evidence Aid: Knowledge saves lives after natural disasters (guardian.co.uk)
Local efforts can stem the increasing unnecessary cesarean sections (eurekalert.org)

04 octubre, 2008

Rosiglitazona y Riesgo Cardiovascular

Long-term Risk of Cardiovascular Events With Rosiglitazone

A Meta-analysis

Sonal Singh, MD; Yoon K. Loke, MBBS, MD; Curt D. Furberg, MD, PhD

JAMA. 2007;298:1189-1195.

Context Recent reports of serious adverse events withrosiglitazone use have raised questions about whether the evidenceof harm justifies its use for treatment of type 2 diabetes.

Objective To systematically review the long-term cardiovascularrisks of rosiglitazone, including myocardial infarction, heartfailure, and cardiovascular mortality.

Data Sources We searched MEDLINE, the GlaxoSmithKlineclinical trials register, the US Food and Drug AdministrationWeb site, and product information sheets for randomized controlledtrials, systematic reviews, and meta-analyses published in Englishthrough May 2007.

Study Selection Studies were selected for inclusion ifthey were randomized controlled trials of rosiglitazone forprevention or treatment of type 2 diabetes, had at least 12months of follow-up, and monitored cardiovascular adverse eventsand provided numerical data on all adverse events. Four studieswere included after detailed screening of 140 trials for cardiovascularevents.

Data Extraction Relative risks (RRs) of myocardial infarction,heart failure, and cardiovascular mortality were estimated usinga fixed-effects meta-analysis of 4 randomized controlled trials(n = 14 291, including 6421 receiving rosiglitazoneand 7870 receiving control therapy, with a duration of follow-upof 1-4 years).

Results Rosiglitazone significantly increased the riskof myocardial infarction (n = 94/6421 vs 83/7870;RR, 1.42; 95% confidence interval [CI], 1.06-1.91; P = .02)and heart failure (n = 102/6421 vs 62/7870; RR, 2.09;95% CI, 1.52-2.88; P < .001) without a significantincrease in risk of cardiovascular mortality (n = 59/6421vs 72/7870; RR, 0.90; 95% CI, 0.63-1.26; P = .53).There was no evidence of substantial heterogeneity among thetrials for these end points (I² = 0% for myocardialinfarction, 18% for heart failure, and 0% for cardiovascularmortality).

Conclusion Among patients with impaired glucose toleranceor type 2 diabetes, rosiglitazone use for at least 12 monthsis associated with a significantly increased risk of myocardialinfarction and heart failure, without a significantly increasedrisk of cardiovascular mortality.

Author Affiliations: Department of Medicine (Dr Singh) and Division of Public Health Sciences (Dr Furberg), Wake Forest University School of Medicine, Winston-Salem, North Carolina; and School of Medicine, Health Policy and Practice, University of East Anglia, Norwich, England (Dr Loke).

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