Sistematski pregled / meta-analiza 2023
Infekcije i imunitet

Fizičke intervencije za zaustavljanje ili smanjenje širenja respiratornih virusa.

The Cochrane database of systematic reviews

Bosanski prijevod

Sažetak istraživanja

Pozadina Virusne epidemije ili pandemije akutnih respiratornih infekcija (ARI) predstavljaju globalnu prijetnju. Primjeri su gripa (H1N1) uzrokovana virusom H1N1pdm09 2009. godine, teški akutni respiratorni sindrom (SARS) 2003. godine i bolest korona virusa 2019. (COVID-19) uzrokovana SARS-CoV-2 2019. Antivirusni lijekovi mogu spriječiti njihovo širenje i usisavanje. Ovo je ažuriranje Cochrane pregleda koji je posljednji put objavljen 2020. Uključujemo rezultate studija iz trenutne pandemije COVID-19.

Ciljevi Procijeniti učinkovitost fizičkih intervencija za zaustavljanje ili smanjenje širenja akutnih respiratornih virusa.

Metode pretraživanja Pretražili smo CENTRAL, PubMed, Embase, CINAHL i dva registra ispitivanja u oktobru 2022. godine, sa analizom citata unazad i naprijed na novim studijama. Kriterijumi odabira Uključili smo randomizirana kontrolirana ispitivanja (RCT) i klaster-RCT koji su istraživali fizičke intervencije (skrining na ulaznim lukama, izolacija, karantin, fizičko distanciranje, lična zaštita, higijena ruku, maske za lice, naočale i grgljanje) kako bi se spriječio prijenos respiratornog virusa. PRIKUPLJANJE I ANALIZA PODATAKA: Koristili smo standardne Cochrane metodološke procedure. Glavni rezultati U ovo ažuriranje uključili smo 11 novih RCT-ova i klaster-RCT-a (610.872 učesnika), čime je ukupan broj RCT-ova porastao na 78. Šest novih ispitivanja sprovedeno je tokom pandemije COVID-19; dva iz Meksika i po jedan iz Danske, Bangladeša, Engleske i Norveške. Identificirali smo četiri tekuće studije, od kojih je jedna završena, ali neprijavljena, koja procjenjuje maske u isto vrijeme s pandemijom COVID-19. Mnoge studije su sprovedene tokom neepidemijskih perioda gripa. Nekoliko je provedeno tokom pandemije gripe H1N1 2009., a druge u sezonama epidemije gripe do 2016. Stoga su mnoga istraživanja provedena u kontekstu niže respiratorne cirkulacije i prijenosa virusa u odnosu na COVID-19. Uključene studije su sprovedene u heterogenim okruženjima, u rasponu od prigradskih škola do bolničkih odeljenja u zemljama sa visokim prihodima; pretrpano okruženje u centru grada u zemljama sa niskim prihodima; i naselje imigranata u zemlji s visokim prihodima. Usklađenost sa intervencijama bila je niska u mnogim studijama. Rizik od pristranosti za RCT i cluster-RCT je uglavnom bio visok ili nejasan. Medicinske/hirurške maske u poređenju bez maski Uključili smo 12 ispitivanja (10 klaster-RCT) u kojima su upoređivane medicinske/hirurške maske sa bez maski kako bi se spriječilo širenje virusnih respiratornih bolesti (dva ispitivanja sa zdravstvenim radnicima i 10 u zajednici). Nošenje maski u zajednici vjerovatno ima malu ili nikakvu razliku u ishodu bolesti sličnih gripi (ILI)/COVID-19 u poređenju sa nenošenjem maski (omjer rizika (RR) 0,95, 95% interval povjerenja (CI) 0,84 do 1. 09.; 76 ispitanika, ispitanici, 96 dokaza, 9 Nošenje maski u zajednici vjerovatno ima malu ili nikakvu razliku u ishodu laboratorijski potvrđene gripe/SARS-CoV-2 u poređenju sa nenošenjem maski (RR 1.01, 95% CI 0.72 do 1.42; 6 ispitivanja, 13.919 učesnika; umjerena izvjesnost i pouzdanost). dokazi niske sigurnosti N95/P2 respiratori u poređenju sa medicinskim/hirurškim maskama Objedinili smo ispitivanja u kojima smo upoređivali respiratore N95/P2 sa medicinskim/hirurškim maskama (četiri u zdravstvenim ustanovama i jedna u domaćinstvu). Veoma smo nesigurni u pogledu efekata N95/P2 respiratora u poređenju sa medicinskim/hirurškim maskama na ishod kliničke respiratorne bolesti (RR 0,70, 95% CI 0,45 do 1,10; 3 ispitivanja, 7779 učesnika; dokazi sa vrlo malom sigurnošću). N95/P2 respiratori u poređenju sa medicinskim/hirurškim maskama mogu biti efikasni za ILI (RR 0,82, 95% CI 0,66 do 1,03; 5 ispitivanja, 8407 učesnika; dokazi niske sigurnosti). Dokazi su ograničeni nepreciznošću i heterogenošću za ove subjektivne ishode. Upotreba respiratora N95/P2 u poređenju sa medicinskim/hirurškim maskama vjerovatno čini malu ili nikakvu razliku za objektivni i precizniji ishod laboratorijski potvrđene infekcije gripom (RR 1,10, 95% CI 0,90 do 1,34; 5 ispitivanja, 8407 učesnika; umjerena sigurnost). Ograničavanje udruživanja na zdravstvene radnike nije uticalo na ukupne nalaze. Štete su loše izmjerene i prijavljene, ali je u nekoliko studija spomenuta neugodnost nošenja medicinskih/hirurških maski ili N95/P2 respiratora (dokazi vrlo niske sigurnosti). Jedan od ranije prijavljenih tekući RCT je sada objavljen i uočeno je da medicinske/hirurške maske nisu inferiorne u odnosu na N95 respiratore u velikoj studiji od 1009 zdravstvenih radnika u četiri zemlje koji pružaju direktnu negu pacijentima sa COVID-19. Higijena ruku u poređenju sa kontrolom Devetnaest studija je uporedilo intervencije higijene ruku sa kontrolama sa dovoljno podataka za uključivanje u meta-analize. Postavke su uključivale škole, centre za brigu o djeci i domove. Upoređujući intervencije higijene ruku sa kontrolama (tj. bez intervencije), došlo je do relativnog smanjenja broja ljudi sa ARI u grupi za higijenu ruku (RR 0,86, 95% CI 0,81 do 0,90; 9 ispitivanja, 52,105 učesnika; dokazi umjereni). U apsolutnom smislu ova korist bi rezultirala smanjenjem sa 380 događaja na 1000 ljudi na 327 na 1000 ljudi (95% CI 308 do 342). Kada se uzmu u obzir strožije definisani ishodi ILI i laboratorijski potvrđene gripe, procjene efekta na ILI (RR 0,94, 95% CI 0,81 do 1. 09; 11 ispitivanja, 34 503 učesnika; dokazi niske sigurnosti) i laboratorijski potvrđeni fluenzac (RR1,90% RR. 0. 63 do 1. 30, 8.332 učesnika), ukazuju na to da je intervencija napravila malu ili nikakvu razliku; Objedinili smo 19 studija (71.210 učesnika) za kompozitni ishod ARI ili ILI ili gripa, pri čemu je svaka studija doprinijela samo jednom i prijavljen je najsveobuhvatniji ishod. Objedinjeni podaci su pokazali da higijena ruku može biti korisna uz relativno smanjenje respiratornih bolesti od 11% (RR 0,89, 95% CI 0,83 do 0,94; dokazi niske sigurnosti), ali sa visokom heterogenošću. U apsolutnom smislu ova korist bi rezultirala smanjenjem sa 200 događaja na 1000 ljudi na 178 na 1000 ljudi (95% CI 166 do 188). Nekoliko ispitivanja mjerilo je i prijavljivalo štetu (dokazi vrlo niske sigurnosti). Nismo pronašli RCT-ove na haljinama i rukavicama, štitnicima za lice ili pregledima na ulaznim lukama.

Zaključci autora Visok rizik od pristrasnosti u ispitivanjima, varijacije u mjerenju ishoda i relativno nisko pridržavanje intervencija tokom studija ometaju donošenje čvrstih zaključaka. Tokom pandemije bilo je dodatnih RCT-ova vezanih za fizičke intervencije, ali relativno malo s obzirom na važnost pitanja maskiranja i njegove relativne efikasnosti i pratećih mjera pridržavanja maske koje bi bile vrlo relevantne za mjerenje efikasnosti, posebno kod starijih osoba i male djece. Postoji neizvjesnost o efektima maski za lice. Niska do umjerena sigurnost dokaza znači da je naše povjerenje u procjenu efekta ograničeno i da se pravi efekat može razlikovati od uočene procjene efekta. Objedinjeni rezultati RCT-a nisu pokazali jasno smanjenje respiratornih virusnih infekcija uz upotrebu medicinskih/hirurških maski. Nije bilo jasnih razlika između upotrebe medicinskih/hirurških maski u poređenju sa respiratorima N95/P2 kod zdravstvenih radnika kada se koriste u rutinskoj njezi za smanjenje respiratorne virusne infekcije. Higijena ruku će vjerovatno umjereno smanjiti teret respiratornih bolesti, i iako je ovaj efekat bio prisutan i kada su ILI i laboratorijski potvrđena gripa analizirani odvojeno, nije utvrđeno da postoji značajna razlika za posljednja dva ishoda. Štete povezane s fizičkim intervencijama nisu dovoljno istražene. Postoji potreba za velikim, dobro osmišljenim RCT-ovima koji bi se bavili efektivnošću mnogih od ovih intervencija u više okruženja i populacija, kao i uticajem pridržavanja na efikasnost, posebno kod onih koji su najviše izloženi riziku od ARI.

Prikaži originalni naslov i sažetak na engleskom

Physical interventions to interrupt or reduce the spread of respiratory viruses.

Background Viral epidemics or pandemics of acute respiratory infections (ARIs) pose a global threat. Examples are influenza (H1N1) caused by the H1N1pdm09 virus in 2009, severe acute respiratory syndrome (SARS) in 2003, and coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in 2019. Antiviral drugs and vaccines may be insufficient to prevent their spread. This is an update of a Cochrane Review last published in 2020. We include results from studies from the current COVID-19 pandemic.

Objectives To assess the effectiveness of physical interventions to interrupt or reduce the spread of acute respiratory viruses. Search methods We searched CENTRAL, PubMed, Embase, CINAHL, and two trials registers in October 2022, with backwards and forwards citation analysis on the new studies. Selection criteria We included randomised controlled trials (RCTs) and cluster-RCTs investigating physical interventions (screening at entry ports, isolation, quarantine, physical distancing, personal protection, hand hygiene, face masks, glasses, and gargling) to prevent respiratory virus transmission. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. Main results We included 11 new RCTs and cluster-RCTs (610,872 participants) in this update, bringing the total number of RCTs to 78. Six of the new trials were conducted during the COVID-19 pandemic; two from Mexico, and one each from Denmark, Bangladesh, England, and Norway. We identified four ongoing studies, of which one is completed, but unreported, evaluating masks concurrent with the COVID-19 pandemic. Many studies were conducted during non-epidemic influenza periods. Several were conducted during the 2009 H1N1 influenza pandemic, and others in epidemic influenza seasons up to 2016. Therefore, many studies were conducted in the context of lower respiratory viral circulation and transmission compared to COVID-19. The included studies were conducted in heterogeneous settings, ranging from suburban schools to hospital wards in high-income countries; crowded inner city settings in low-income countries; and an immigrant neighbourhood in a high-income country. Adherence with interventions was low in many studies. The risk of bias for the RCTs and cluster-RCTs was mostly high or unclear. Medical/surgical masks compared to no masks We included 12 trials (10 cluster-RCTs) comparing medical/surgical masks versus no masks to prevent the spread of viral respiratory illness (two trials with healthcare workers and 10 in the community). Wearing masks in the community probably makes little or no difference to the outcome of influenza-like illness (ILI)/COVID-19 like illness compared to not wearing masks (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.84 to 1.09; 9 trials, 276,917 participants; moderate-certainty evidence. Wearing masks in the community probably makes little or no difference to the outcome of laboratory-confirmed influenza/SARS-CoV-2 compared to not wearing masks (RR 1.01, 95% CI 0.72 to 1.42; 6 trials, 13,919 participants; moderate-certainty evidence). Harms were rarely measured and poorly reported (very low-certainty evidence). N95/P2 respirators compared to medical/surgical masks We pooled trials comparing N95/P2 respirators with medical/surgical masks (four in healthcare settings and one in a household setting). We are very uncertain on the effects of N95/P2 respirators compared with medical/surgical masks on the outcome of clinical respiratory illness (RR 0.70, 95% CI 0.45 to 1.10; 3 trials, 7779 participants; very low-certainty evidence). N95/P2 respirators compared with medical/surgical masks may be effective for ILI (RR 0.82, 95% CI 0.66 to 1.03; 5 trials, 8407 participants; low-certainty evidence). Evidence is limited by imprecision and heterogeneity for these subjective outcomes. The use of a N95/P2 respirators compared to medical/surgical masks probably makes little or no difference for the objective and more precise outcome of laboratory-confirmed influenza infection (RR 1.10, 95% CI 0.90 to 1.34; 5 trials, 8407 participants; moderate-certainty evidence). Restricting pooling to healthcare workers made no difference to the overall findings. Harms were poorly measured and reported, but discomfort wearing medical/surgical masks or N95/P2 respirators was mentioned in several studies (very low-certainty evidence). One previously reported ongoing RCT has now been published and observed that medical/surgical masks were non-inferior to N95 respirators in a large study of 1009 healthcare workers in four countries providing direct care to COVID-19 patients. Hand hygiene compared to control Nineteen trials compared hand hygiene interventions with controls with sufficient data to include in meta-analyses. Settings included schools, childcare centres and homes. Comparing hand hygiene interventions with controls (i.e. no intervention), there was a 14% relative reduction in the number of people with ARIs in the hand hygiene group (RR 0.86, 95% CI 0.81 to 0.90; 9 trials, 52,105 participants; moderate-certainty evidence), suggesting a probable benefit. In absolute terms this benefit would result in a reduction from 380 events per 1000 people to 327 per 1000 people (95% CI 308 to 342). When considering the more strictly defined outcomes of ILI and laboratory-confirmed influenza, the estimates of effect for ILI (RR 0.94, 95% CI 0.81 to 1.09; 11 trials, 34,503 participants; low-certainty evidence), and laboratory-confirmed influenza (RR 0.91, 95% CI 0.63 to 1.30; 8 trials, 8332 participants; low-certainty evidence), suggest the intervention made little or no difference. We pooled 19 trials (71, 210 participants) for the composite outcome of ARI or ILI or influenza, with each study only contributing once and the most comprehensive outcome reported. Pooled data showed that hand hygiene may be beneficial with an 11% relative reduction of respiratory illness (RR 0.89, 95% CI 0.83 to 0.94; low-certainty evidence), but with high heterogeneity. In absolute terms this benefit would result in a reduction from 200 events per 1000 people to 178 per 1000 people (95% CI 166 to 188). Few trials measured and reported harms (very low-certainty evidence). We found no RCTs on gowns and gloves, face shields, or screening at entry ports. Authors' conclusions The high risk of bias in the trials, variation in outcome measurement, and relatively low adherence with the interventions during the studies hampers drawing firm conclusions. There were additional RCTs during the pandemic related to physical interventions but a relative paucity given the importance of the question of masking and its relative effectiveness and the concomitant measures of mask adherence which would be highly relevant to the measurement of effectiveness, especially in the elderly and in young children. There is uncertainty about the effects of face masks. The low to moderate certainty of evidence means our confidence in the effect estimate is limited, and that the true effect may be different from the observed estimate of the effect. The pooled results of RCTs did not show a clear reduction in respiratory viral infection with the use of medical/surgical masks. There were no clear differences between the use of medical/surgical masks compared with N95/P2 respirators in healthcare workers when used in routine care to reduce respiratory viral infection. Hand hygiene is likely to modestly reduce the burden of respiratory illness, and although this effect was also present when ILI and laboratory-confirmed influenza were analysed separately, it was not found to be a significant difference for the latter two outcomes. Harms associated with physical interventions were under-investigated. There is a need for large, well-designed RCTs addressing the effectiveness of many of these interventions in multiple settings and populations, as well as the impact of adherence on effectiveness, especially in those most at risk of ARIs.

Autorstvo i publikacija

Autori

Jefferson T, Dooley L, Ferroni E, Al-Ansary LA, van Driel ML, Bawazeer GA, Jones MA, Hoffmann TC, Clark J, Beller EM, Glasziou PP, Conly JM.

Časopis
The Cochrane database of systematic reviews
Vrste publikacije
Istraživačka podrška vlade izvan SAD-a, Sistematski pregled, Sistematski pregled, Članak u časopisu
Licenca
CC BY
Citiranja u Europe PMC
148
Provjerljivi identifikatori

Izvorni podaci

DOI
10.1002/14651858.cd006207.pub6
PMID
36715243
PMCID
PMC9885521
Provjereno
2026-07-26
Otvori cijeli rad u Europe PMC
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