Publications by authors named "Ani Movsisyan"

18 Publications

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Non-pharmacological measures implemented in the setting of long-term care facilities to prevent SARS-CoV-2 infections and their consequences: a rapid review.

Cochrane Database Syst Rev 2021 09 15;9:CD015085. Epub 2021 Sep 15.

Institute for Medical Information Processing, Biometry and Epidemiology (IBE), Chair of Public Health and Health Services Research, LMU Munich, Munich, Germany.

Background: Starting in late 2019, COVID-19, caused by the novel coronavirus SARS-CoV-2, spread around the world. Long-term care facilities are at particularly high risk of outbreaks, and the burden of morbidity and mortality is very high among residents living in these facilities.

Objectives: To assess the effects of non-pharmacological measures implemented in long-term care facilities to prevent or reduce the transmission of SARS-CoV-2 infection among residents, staff, and visitors.

Search Methods: On 22 January 2021, we searched the Cochrane COVID-19 Study Register, WHO COVID-19 Global literature on coronavirus disease, Web of Science, and CINAHL. We also conducted backward citation searches of existing reviews.

Selection Criteria: We considered experimental, quasi-experimental, observational and modelling studies that assessed the effects of the measures implemented in long-term care facilities to protect residents and staff against SARS-CoV-2 infection. Primary outcomes were infections, hospitalisations and deaths due to COVID-19, contaminations of and outbreaks in long-term care facilities, and adverse health effects.

Data Collection And Analysis: Two review authors independently screened titles, abstracts and full texts. One review author performed data extractions, risk of bias assessments and quality appraisals, and at least one other author checked their accuracy. Risk of bias and quality assessments were conducted using the ROBINS-I tool for cohort and interrupted-time-series studies, the Joanna Briggs Institute (JBI) checklist for case-control studies, and a bespoke tool for modelling studies. We synthesised findings narratively, focusing on the direction of effect. One review author assessed certainty of evidence with GRADE, with the author team critically discussing the ratings.

Main Results: We included 11 observational studies and 11 modelling studies in the analysis. All studies were conducted in high-income countries. Most studies compared outcomes in long-term care facilities that implemented the measures with predicted or observed control scenarios without the measure (but often with baseline infection control measures also in place). Several modelling studies assessed additional comparator scenarios, such as comparing higher with lower rates of testing. There were serious concerns regarding risk of bias in almost all observational studies and major or critical concerns regarding the quality of many modelling studies. Most observational studies did not adequately control for confounding. Many modelling studies used inappropriate assumptions about the structure and input parameters of the models, and failed to adequately assess uncertainty. Overall, we identified five intervention domains, each including a number of specific measures. Entry regulation measures (4 observational studies; 4 modelling studies) Self-confinement of staff with residents may reduce the number of infections, probability of facility contamination, and number of deaths. Quarantine for new admissions may reduce the number of infections. Testing of new admissions and intensified testing of residents and of staff after holidays may reduce the number of infections, but the evidence is very uncertain. The evidence is very uncertain regarding whether restricting admissions of new residents reduces the number of infections, but the measure may reduce the probability of facility contamination. Visiting restrictions may reduce the number of infections and deaths. Furthermore, it may increase the probability of facility contamination, but the evidence is very uncertain. It is very uncertain how visiting restrictions may adversely affect the mental health of residents. Contact-regulating and transmission-reducing measures (6 observational studies; 2 modelling studies) Barrier nursing may increase the number of infections and the probability of outbreaks, but the evidence is very uncertain. Multicomponent cleaning and environmental hygiene measures may reduce the number of infections, but the evidence is very uncertain. It is unclear how contact reduction measures affect the probability of outbreaks. These measures may reduce the number of infections, but the evidence is very uncertain. Personal hygiene measures may reduce the probability of outbreaks, but the evidence is very uncertain.  Mask and personal protective equipment usage may reduce the number of infections, the probability of outbreaks, and the number of deaths, but the evidence is very uncertain. Cohorting residents and staff may reduce the number of infections, although evidence is very uncertain. Multicomponent contact -regulating and transmission -reducing measures may reduce the probability of outbreaks, but the evidence is very uncertain. Surveillance measures (2 observational studies; 6 modelling studies) Routine testing of residents and staff independent of symptoms may reduce the number of infections. It may reduce the probability of outbreaks, but the evidence is very uncertain. Evidence from one observational study suggests that the measure may reduce, while the evidence from one modelling study suggests that it probably reduces hospitalisations. The measure may reduce the number of deaths among residents, but the evidence on deaths among staff is unclear.  Symptom-based surveillance testing may reduce the number of infections and the probability of outbreaks, but the evidence is very uncertain. Outbreak control measures (4 observational studies; 3 modelling studies) Separating infected and non-infected residents or staff caring for them may reduce the number of infections. The measure may reduce the probability of outbreaks and may reduce the number of deaths, but the evidence for the latter is very uncertain. Isolation of cases may reduce the number of infections and the probability of outbreaks, but the evidence is very uncertain. Multicomponent measures (2 observational studies; 1 modelling study) A combination of multiple infection-control measures, including various combinations of the above categories, may reduce the number of infections and may reduce the number of deaths, but the evidence for the latter is very uncertain.

Authors' Conclusions: This review provides a comprehensive framework and synthesis of a range of non-pharmacological measures implemented in long-term care facilities. These may prevent SARS-CoV-2 infections and their consequences. However, the certainty of evidence is predominantly low to very low, due to the limited availability of evidence and the design and quality of available studies. Therefore, true effects may be substantially different from those reported here. Overall, more studies producing stronger evidence on the effects of non-pharmacological measures are needed, especially in low- and middle-income countries and on possible unintended consequences of these measures. Future research should explore the reasons behind the paucity of evidence to guide pandemic research priority setting in the future.
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http://dx.doi.org/10.1002/14651858.CD015085.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8442144PMC
September 2021

Unintended health and societal consequences of international travel measures during the COVID-19 pandemic: a scoping review.

J Travel Med 2021 10;28(7)

Chair of Public Health and Health Services Research, Institute for Medical Information Processing, Biometry, and Epidemiology - IBE, LMU Munich, Elisabeth-Winterhalter-Weg 6, 81377 Munich, Germany.

Background/objective: International travel measures to contain the coronavirus disease of 2019 (COVID-19) pandemic represent a relatively intrusive form of non-pharmaceutical intervention. To inform decision-making on the (re)implementation, adaptation, relaxation or suspension of such measures, it is essential to not only assess their effectiveness but also their unintended effects.

Methods: This scoping review maps existing empirical studies on the unintended consequences, both predicted and unforeseen, and beneficial or harmful, of international travel measures. We searched multiple health, non-health and COVID-19-specific databases. The evidence was charted in a map in relation to the study design, intervention and outcome categories identified and discussed narratively.

Results: Twenty-three studies met our inclusion criteria-nine quasi-experimental, two observational, two mathematical modelling, six qualitative and four mixed-methods studies. Studies addressed different population groups across various countries worldwide. Seven studies provided information on unintended consequences of the closure of national borders, six looked at international travel restrictions and three investigated mandatory quarantine of international travellers. No studies looked at entry and/or exit screening at national borders exclusively, however six studies considered this intervention in combination with other international travel measures. In total, 11 studies assessed various combinations of the aforementioned interventions. The outcomes were mostly referred to by the authors as harmful. Fifteen studies identified a variety of economic consequences, six reported on aspects related to quality of life, well-being, and mental health and five on social consequences. One study each provided information on equity, equality, and the fair distribution of benefits and burdens, environmental consequences and health system consequences.

Conclusion: This scoping review represents the first step towards a systematic assessment of the unintended benefits and harms of international travel measures during COVID-19. The key research gaps identified might be filled with targeted primary research, as well as the additional consideration of gray literature and non-empirical studies.
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http://dx.doi.org/10.1093/jtm/taab123DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8436381PMC
October 2021

Adapting interventions to new contexts-the ADAPT guidance.

BMJ 2021 08 3;374:n1679. Epub 2021 Aug 3.

Centre for Development, Evaluation, Complexity and Implementation in Public Health improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, UK.

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http://dx.doi.org/10.1136/bmj.n1679DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8329746PMC
August 2021

Travel-related control measures to contain the COVID-19 pandemic: an evidence map.

BMJ Open 2021 04 9;11(4):e041619. Epub 2021 Apr 9.

Institute for Medical Information Processing, Biometry and Epidemiology, Ludwig Maximilians University Munich, Munich, Germany.

Objectives: To comprehensively map the existing evidence assessing the impact of travel-related control measures for containment of the SARS-CoV-2/COVID-19 pandemic.

Design: Rapid evidence map.

Data Sources: MEDLINE, Embase and Web of Science, and COVID-19 specific databases offered by the US Centers for Disease Control and Prevention and the WHO.

Eligibility Criteria: We included studies in human populations susceptible to SARS-CoV-2/COVID-19, SARS-CoV-1/severe acute respiratory syndrome, Middle East respiratory syndrome coronavirus/Middle East respiratory syndrome or influenza. Interventions of interest were travel-related control measures affecting travel across national or subnational borders. Outcomes of interest included infectious disease, screening, other health, economic and social outcomes. We considered all empirical studies that quantitatively evaluate impact available in Armenian, English, French, German, Italian and Russian based on the team's language capacities.

Data Extraction And Synthesis: We extracted data from included studies in a standardised manner and mapped them to a priori and (one) post hoc defined categories.

Results: We included 122 studies assessing travel-related control measures. These studies were undertaken across the globe, most in the Western Pacific region (n=71). A large proportion of studies focused on COVID-19 (n=59), but a number of studies also examined SARS, MERS and influenza. We identified studies on border closures (n=3), entry/exit screening (n=31), travel-related quarantine (n=6), travel bans (n=8) and travel restrictions (n=25). Many addressed a bundle of travel-related control measures (n=49). Most studies assessed infectious disease (n=98) and/or screening-related (n=25) outcomes; we found only limited evidence on economic and social outcomes. Studies applied numerous methods, both inferential and descriptive in nature, ranging from simple observational methods to complex modelling techniques.

Conclusions: We identified a heterogeneous and complex evidence base on travel-related control measures. While this map is not sufficient to assess the effectiveness of different measures, it outlines aspects regarding interventions and outcomes, as well as study methodology and reporting that could inform future research and evidence synthesis.
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http://dx.doi.org/10.1136/bmjopen-2020-041619DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8042592PMC
April 2021

International travel-related control measures to contain the COVID-19 pandemic: a rapid review.

Cochrane Database Syst Rev 2021 03 25;3:CD013717. Epub 2021 Mar 25.

Institute for Medical Information Processing, Biometry and Epidemiology (IBE), Chair of Public Health and Health Services Research, LMU Munich, Munich, Germany.

Background: In late 2019, the first cases of coronavirus disease 2019 (COVID-19) were reported in Wuhan, China, followed by a worldwide spread. Numerous countries have implemented control measures related to international travel, including border closures, travel restrictions, screening at borders, and quarantine of travellers.

Objectives: To assess the effectiveness of international travel-related control measures during the COVID-19 pandemic on infectious disease transmission and screening-related outcomes.

Search Methods: We searched MEDLINE, Embase and COVID-19-specific databases, including the Cochrane COVID-19 Study Register and the WHO Global Database on COVID-19 Research to 13 November 2020.

Selection Criteria: We considered experimental, quasi-experimental, observational and modelling studies assessing the effects of travel-related control measures affecting human travel across international borders during the COVID-19 pandemic. In the original review, we also considered evidence on severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). In this version we decided to focus on COVID-19 evidence only. Primary outcome categories were (i) cases avoided, (ii) cases detected, and (iii) a shift in epidemic development. Secondary outcomes were other infectious disease transmission outcomes, healthcare utilisation, resource requirements and adverse effects if identified in studies assessing at least one primary outcome.

Data Collection And Analysis: Two review authors independently screened titles and abstracts and subsequently full texts. For studies included in the analysis, one review author extracted data and appraised the study. At least one additional review author checked for correctness of data. To assess the risk of bias and quality of included studies, we used the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool for observational studies concerned with screening, and a bespoke tool for modelling studies. We synthesised findings narratively. One review author assessed the certainty of evidence with GRADE, and several review authors discussed these GRADE judgements.

Main Results: Overall, we included 62 unique studies in the analysis; 49 were modelling studies and 13 were observational studies. Studies covered a variety of settings and levels of community transmission. Most studies compared travel-related control measures against a counterfactual scenario in which the measure was not implemented. However, some modelling studies described additional comparator scenarios, such as different levels of stringency of the measures (including relaxation of restrictions), or a combination of measures. Concerns with the quality of modelling studies related to potentially inappropriate assumptions about the structure and input parameters, and an inadequate assessment of model uncertainty. Concerns with risk of bias in observational studies related to the selection of travellers and the reference test, and unclear reporting of certain methodological aspects. Below we outline the results for each intervention category by illustrating the findings from selected outcomes. Travel restrictions reducing or stopping cross-border travel (31 modelling studies) The studies assessed cases avoided and shift in epidemic development. We found very low-certainty evidence for a reduction in COVID-19 cases in the community (13 studies) and cases exported or imported (9 studies). Most studies reported positive effects, with effect sizes varying widely; only a few studies showed no effect. There was very low-certainty evidence that cross-border travel controls can slow the spread of COVID-19. Most studies predicted positive effects, however, results from individual studies varied from a delay of less than one day to a delay of 85 days; very few studies predicted no effect of the measure. Screening at borders (13 modelling studies; 13 observational studies) Screening measures covered symptom/exposure-based screening or test-based screening (commonly specifying polymerase chain reaction (PCR) testing), or both, before departure or upon or within a few days of arrival. Studies assessed cases avoided, shift in epidemic development and cases detected. Studies generally predicted or observed some benefit from screening at borders, however these varied widely. For symptom/exposure-based screening, one modelling study reported that global implementation of screening measures would reduce the number of cases exported per day from another country by 82% (95% confidence interval (CI) 72% to 95%) (moderate-certainty evidence). Four modelling studies predicted delays in epidemic development, although there was wide variation in the results between the studies (very low-certainty evidence). Four modelling studies predicted that the proportion of cases detected would range from 1% to 53% (very low-certainty evidence). Nine observational studies observed the detected proportion to range from 0% to 100% (very low-certainty evidence), although all but one study observed this proportion to be less than 54%. For test-based screening, one modelling study provided very low-certainty evidence for the number of cases avoided. It reported that testing travellers reduced imported or exported cases as well as secondary cases. Five observational studies observed that the proportion of cases detected varied from 58% to 90% (very low-certainty evidence). Quarantine (12 modelling studies) The studies assessed cases avoided, shift in epidemic development and cases detected. All studies suggested some benefit of quarantine, however the magnitude of the effect ranged from small to large across the different outcomes (very low- to low-certainty evidence). Three modelling studies predicted that the reduction in the number of cases in the community ranged from 450 to over 64,000 fewer cases (very low-certainty evidence). The variation in effect was possibly related to the duration of quarantine and compliance. Quarantine and screening at borders (7 modelling studies; 4 observational studies) The studies assessed shift in epidemic development and cases detected. Most studies predicted positive effects for the combined measures with varying magnitudes (very low- to low-certainty evidence). Four observational studies observed that the proportion of cases detected for quarantine and screening at borders ranged from 68% to 92% (low-certainty evidence). The variation may depend on how the measures were combined, including the length of the quarantine period and days when the test was conducted in quarantine.

Authors' Conclusions: With much of the evidence derived from modelling studies, notably for travel restrictions reducing or stopping cross-border travel and quarantine of travellers, there is a lack of 'real-world' evidence. The certainty of the evidence for most travel-related control measures and outcomes is very low and the true effects are likely to be substantially different from those reported here. Broadly, travel restrictions may limit the spread of disease across national borders. Symptom/exposure-based screening measures at borders on their own are likely not effective; PCR testing at borders as a screening measure likely detects more cases than symptom/exposure-based screening at borders, although if performed only upon arrival this will likely also miss a meaningful proportion of cases. Quarantine, based on a sufficiently long quarantine period and high compliance is likely to largely avoid further transmission from travellers. Combining quarantine with PCR testing at borders will likely improve effectiveness. Many studies suggest that effects depend on factors, such as levels of community transmission, travel volumes and duration, other public health measures in place, and the exact specification and timing of the measure. Future research should be better reported, employ a range of designs beyond modelling and assess potential benefits and harms of the travel-related control measures from a societal perspective.
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http://dx.doi.org/10.1002/14651858.CD013717.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8406796PMC
March 2021

Border control and SARS-CoV-2: an opportunity for generating highly policy-relevant, real-world evidence.

J Travel Med 2021 06;28(4)

Institute for Medical Information Processing, Biometry and Epidemiology-IBE, Chair of Public Health and Health Services Research, LMU Munich, Munich, Germany.

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http://dx.doi.org/10.1093/jtm/taab037DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7989420PMC
June 2021

Interventions to Ameliorate the Psychosocial Effects of the COVID-19 Pandemic on Children-A Systematic Review.

Int J Environ Res Public Health 2021 02 28;18(5). Epub 2021 Feb 28.

Institute for Medical Information Processing, Biometry and Epidemiology-IBE, Chair of Public Health and Health Services Research, LMU Munich, Elisabeth-Winterhalter-Weg 6, 81377 Munich, Germany.

The aim of this study was to identify interventions targeting children and their caregivers to reduce psychosocial problems in the course of the COVID-19 pandemic and comparable outbreaks. The review was performed using systematic literature searches in MEDLINE, Embase, PsycINFO and COVID-19-specific databases, including the CDC COVID-19 Research Database, the World Health Organisation (WHO) Global Database on COVID-19 Research and the Cochrane COVID-19 Study Register, ClinicalTrials.gov, the EU Clinical Trials Register and the German Clinical Trials Register (DRKS) up to 25th September 2020. The search yielded 6657 unique citations. After title/abstract and full text screening, 11 study protocols reporting on trials planned in China, the US, Canada, the UK, and Hungary during the COVID-19 pandemic were included. Four interventions targeted children ≥10 years directly, seven system-based interventions targeted the parents and caregivers of younger children and adolescents. Outcome measures encompassed mainly anxiety and depressive symptoms, different dimensions of stress or psychosocial well-being, and quality of supportive relationships. In conclusion, this systematic review revealed a paucity of studies on psychosocial interventions for children during the COVID-19 pandemic. Further research should be encouraged in light of the expected demand for child mental health management.
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http://dx.doi.org/10.3390/ijerph18052361DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7967755PMC
February 2021

Travel-related control measures to contain the COVID-19 pandemic: a rapid review.

Cochrane Database Syst Rev 2020 10 5;10:CD013717. Epub 2020 Oct 5.

Institute for Medical Information Processing, Biometry and Epidemiology, IBE, LMU Munich, Munich, Germany.

Background: In late 2019, first cases of coronavirus disease 2019, or COVID-19, caused by the novel coronavirus SARS-CoV-2, were reported in Wuhan, China. Subsequently COVID-19 spread rapidly around the world. To contain the ensuing pandemic, numerous countries have implemented control measures related to international travel, including border closures, partial travel restrictions, entry or exit screening, and quarantine of travellers.

Objectives: To assess the effectiveness of travel-related control measures during the COVID-19 pandemic on infectious disease and screening-related outcomes.

Search Methods: We searched MEDLINE, Embase and COVID-19-specific databases, including the WHO Global Database on COVID-19 Research, the Cochrane COVID-19 Study Register, and the CDC COVID-19 Research Database on 26 June 2020. We also conducted backward-citation searches with existing reviews.

Selection Criteria: We considered experimental, quasi-experimental, observational and modelling studies assessing the effects of travel-related control measures affecting human travel across national borders during the COVID-19 pandemic. We also included studies concerned with severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) as indirect evidence. Primary outcomes were cases avoided, cases detected and a shift in epidemic development due to the measures. Secondary outcomes were other infectious disease transmission outcomes, healthcare utilisation, resource requirements and adverse effects if identified in studies assessing at least one primary outcome.

Data Collection And Analysis: One review author screened titles and abstracts; all excluded abstracts were screened in duplicate. Two review authors independently screened full texts. One review author extracted data, assessed risk of bias and appraised study quality. At least one additional review author checked for correctness of all data reported in the 'Risk of bias' assessment, quality appraisal and data synthesis. For assessing the risk of bias and quality of included studies, we used the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool for observational studies concerned with screening, ROBINS-I for observational ecological studies and a bespoke tool for modelling studies. We synthesised findings narratively. One review author assessed certainty of evidence with GRADE, and the review author team discussed ratings.

Main Results: We included 40 records reporting on 36 unique studies. We found 17 modelling studies, 7 observational screening studies and one observational ecological study on COVID-19, four modelling and six observational studies on SARS, and one modelling study on SARS and MERS, covering a variety of settings and epidemic stages. Most studies compared travel-related control measures against a counterfactual scenario in which the intervention measure was not implemented. However, some modelling studies described additional comparator scenarios, such as different levels of travel restrictions, or a combination of measures. There were concerns with the quality of many modelling studies and the risk of bias of observational studies. Many modelling studies used potentially inappropriate assumptions about the structure and input parameters of models, and failed to adequately assess uncertainty. Concerns with observational screening studies commonly related to the reference test and the flow of the screening process. Studies on COVID-19 Travel restrictions reducing cross-border travel Eleven studies employed models to simulate a reduction in travel volume; one observational ecological study assessed travel restrictions in response to the COVID-19 pandemic. Very low-certainty evidence from modelling studies suggests that when implemented at the beginning of the outbreak, cross-border travel restrictions may lead to a reduction in the number of new cases of between 26% to 90% (4 studies), the number of deaths (1 study), the time to outbreak of between 2 and 26 days (2 studies), the risk of outbreak of between 1% to 37% (2 studies), and the effective reproduction number (1 modelling and 1 observational ecological study). Low-certainty evidence from modelling studies suggests a reduction in the number of imported or exported cases of between 70% to 81% (5 studies), and in the growth acceleration of epidemic progression (1 study). Screening at borders with or without quarantine Evidence from three modelling studies of entry and exit symptom screening without quarantine suggests delays in the time to outbreak of between 1 to 183 days (very low-certainty evidence) and a detection rate of infected travellers of between 10% to 53% (low-certainty evidence). Six observational studies of entry and exit screening were conducted in specific settings such as evacuation flights and cruise ship outbreaks. Screening approaches varied but followed a similar structure, involving symptom screening of all individuals at departure or upon arrival, followed by quarantine, and different procedures for observation and PCR testing over a period of at least 14 days. The proportion of cases detected ranged from 0% to 91% (depending on the screening approach), and the positive predictive value ranged from 0% to 100% (very low-certainty evidence). The outcomes, however, should be interpreted in relation to both the screening approach used and the prevalence of infection among the travellers screened; for example, symptom-based screening alone generally performed worse than a combination of symptom-based and PCR screening with subsequent observation during quarantine. Quarantine of travellers Evidence from one modelling study simulating a 14-day quarantine suggests a reduction in the number of cases seeded by imported cases; larger reductions were seen with increasing levels of quarantine compliance ranging from 277 to 19 cases with rates of compliance modelled between 70% to 100% (very low-certainty evidence).

Authors' Conclusions: With much of the evidence deriving from modelling studies, notably for travel restrictions reducing cross-border travel and quarantine of travellers, there is a lack of 'real-life' evidence for many of these measures. The certainty of the evidence for most travel-related control measures is very low and the true effects may be substantially different from those reported here. Nevertheless, some travel-related control measures during the COVID-19 pandemic may have a positive impact on infectious disease outcomes. Broadly, travel restrictions may limit the spread of disease across national borders. Entry and exit symptom screening measures on their own are not likely to be effective in detecting a meaningful proportion of cases to prevent seeding new cases within the protected region; combined with subsequent quarantine, observation and PCR testing, the effectiveness is likely to improve. There was insufficient evidence to draw firm conclusions about the effectiveness of travel-related quarantine on its own. Some of the included studies suggest that effects are likely to depend on factors such as the stage of the epidemic, the interconnectedness of countries, local measures undertaken to contain community transmission, and the extent of implementation and adherence.
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http://dx.doi.org/10.1002/14651858.CD013717DOI Listing
October 2020

Selecting Review Outcomes for Systematic Reviews of Public Health Interventions.

Am J Public Health 2021 03 21;111(3):465-470. Epub 2021 Jan 21.

Luke Wolfenden and Sam McCrabb are with the School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Callaghan, Australia. Ani Movsisyan and Jan M. Stratil are with the Institute for Medical Information Processing, Biometry and Epidemiology and the Pettenkofer School of Public Health, Ludwig Maximilian University of Munich, Munich, Germany. Sze Lin Yoong is with the Faculty of Health, Arts and Design, Swinburne University of Technology, Melbourne, Australia.

For systematic reviews to have an impact on public health, they must report outcomes that are important for decision-making. Systematic reviews of public health interventions, however, have a range of potential end users, and identifying and prioritizing the most important and relevant outcomes represents a considerable challenge.In this commentary, we describe potentially useful approaches that systematic review teams can use to identify review outcomes to best inform public health decision-making. Specifically, we discuss the importance of stakeholder engagement, the use of logic models, consideration of core outcome sets, reviews of the literature on end users' needs and preferences, and the use of decision-making frameworks in the selection and prioritization of outcomes included in reviews.The selection of review outcomes is a critical step in the production of public health reviews that are relevant to those who use them. Utilizing the suggested strategies may help the review teams better achieve this.
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http://dx.doi.org/10.2105/AJPH.2020.306061DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7893343PMC
March 2021

Adverse effects of non-steroidal anti-inflammatory drugs in patients with viral respiratory infections: rapid systematic review.

BMJ Open 2020 11 19;10(11):e040990. Epub 2020 Nov 19.

Chair of Public Health and Health Services Research in its capacity as a WHO Collaborating Centre for Evidence-Based Public Health, Institute for Medical Information Processing, Biometry and Epidemiology (IBE), Ludwig Maximilians University Munich Medical Faculty, Munchen, Germany.

Objectives: To assess the effects of non-steroidal anti-inflammatory drugs (NSAIDs) in patients with viral respiratory infections on acute severe adverse outcomes, healthcare utilisation, quality of life and long-term survival.

Design: Rapid systematic review.

Participants: Humans with viral respiratory infections, exposed to systemic NSAIDs.

Primary Outcomes: Acute severe adverse outcomes, healthcare utilisation, quality of life and long-term survival.

Results: We screened 10 999 titles and abstracts and 738 full texts, including 87 studies. No studies addressed COVID-19, Severe Acute Respiratory Syndrome or Middle East Respiratory Syndrome; none examined inpatient healthcare utilisation, quality of life or long-term survival. Effects of NSAIDs on mortality and cardiovascular events in adults with viral respiratory infections are unclear (three observational studies; very low certainty). Children with empyema and gastrointestinal bleeding may be more likely to have taken NSAIDs than children without these conditions (two observational studies; very low certainty). In patients aged 3 years and older with acute respiratory infections, ibuprofen is associated with a higher rate of reconsultations with general practitioners than paracetamol (one randomised controlled trial (RCT); low certainty). The difference in death from all causes and hospitalisation for renal failure and anaphylaxis between children with fever receiving ibuprofen versus paracetamol is likely to be less than 1 per 10 000 (1 RCT; moderate/high certainty). Twenty-eight studies in adults and 42 studies in children report adverse event counts. Most report that no severe adverse events occurred. Due to methodological limitations of adverse event counts, this evidence should be interpreted with caution.

Conclusions: It is unclear whether the use of NSAIDs increases the risk of severe adverse outcomes in patients with viral respiratory infections. This absence of evidence should not be interpreted as evidence for the absence of such risk. This is a rapid review with a number of limitations.

Prospero Registration Number: CRD42020176056.
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http://dx.doi.org/10.1136/bmjopen-2020-040990DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7678345PMC
November 2020

Measures implemented in the school setting to contain the COVID-19 pandemic: a scoping review.

Cochrane Database Syst Rev 2020 12 17;12:CD013812. Epub 2020 Dec 17.

Institute for Medical Information Processing, Biometry and Epidemiology - IBE, Chair of Public Health and Health Services Research, LMU Munich, Munich, Germany.

Background: In response to the spread of SARS-CoV-2 and the impact of COVID-19, national and subnational governments implemented a variety of measures in order to control the spread of the virus and the associated disease. While these measures were imposed with the intention of controlling the pandemic, they were also associated with severe psychosocial, societal, and economic implications on a societal level. One setting affected heavily by these measures is the school setting. By mid-April 2020, 192 countries had closed schools, affecting more than 90% of the world's student population. In consideration of the adverse consequences of school closures, many countries around the world reopened their schools in the months after the initial closures. To safely reopen schools and keep them open, governments implemented a broad range of measures. The evidence with regards to these measures, however, is heterogeneous, with a multitude of study designs, populations, settings, interventions and outcomes being assessed. To make sense of this heterogeneity, we conducted a rapid scoping review (8 October to 5 November 2020). This rapid scoping review is intended to serve as a precursor to a systematic review of effectiveness, which will inform guidelines issued by the World Health Organization (WHO). This review is reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist and was registered with the Open Science Framework.

Objectives: To identify and comprehensively map the evidence assessing the impacts of measures implemented in the school setting to reopen schools, or keep schools open, or both, during the SARS-CoV-2/COVID-19 pandemic, with particular focus on the types of measures implemented in different school settings, the outcomes used to measure their impacts and the study types used to assess these.

Search Methods: We searched the Cochrane COVID-19 Study Register, MEDLINE, Embase, the CDC COVID-19 Research Articles Downloadable Database for preprints, and the WHO COVID-19 Global literature on coronavirus disease on 8 October 2020.

Selection Criteria: We included studies that assessed the impact of measures implemented in the school setting. Eligible populations were populations at risk of becoming infected with SARS-CoV-2, or developing COVID-19 disease, or both, and included people both directly and indirectly impacted by interventions, including students, teachers, other school staff, and contacts of these groups, as well as the broader community. We considered all types of empirical studies, which quantitatively assessed impact including epidemiological studies, modelling studies, mixed-methods studies, and diagnostic studies that assessed the impact of relevant interventions beyond diagnostic test accuracy. Broad outcome categories of interest included infectious disease transmission-related outcomes, other harmful or beneficial health-related outcomes, and societal, economic, and ecological implications.

Data Collection And Analysis: We extracted data from included studies in a standardized manner, and mapped them to categories within our a priori logic model where possible. Where not possible, we inductively developed new categories. In line with standard expectations for scoping reviews, the review provides an overview of the existing evidence regardless of methodological quality or risk of bias, and was not designed to synthesize effectiveness data, assess risk of bias, or characterize strength of evidence (GRADE).

Main Results: We included 42 studies that assessed measures implemented in the school setting. The majority of studies used mathematical modelling designs (n = 31), while nine studies used observational designs, and two studies used experimental or quasi-experimental designs. Studies conducted in real-world contexts or using real data focused on the WHO European region (EUR; n = 20), the WHO region of the Americas (AMR; n = 13), the West Pacific region (WPR; n = 6), and the WHO Eastern Mediterranean Region (EMR; n = 1). One study conducted a global assessment and one did not report on data from, or that were applicable to, a specific country. Three broad intervention categories emerged from the included studies: organizational measures to reduce transmission of SARS-CoV-2 (n = 36), structural/environmental measures to reduce transmission of SARS-CoV-2 (n = 11), and surveillance and response measures to detect SARS-CoV-2 infections (n = 19). Most studies assessed SARS-CoV-2 transmission-related outcomes (n = 29), while others assessed healthcare utilization (n = 8), other health outcomes (n = 3), and societal, economic, and ecological outcomes (n = 5). Studies assessed both harmful and beneficial outcomes across all outcome categories.

Authors' Conclusions: We identified a heterogeneous and complex evidence base of measures implemented in the school setting. This review is an important first step in understanding the available evidence and will inform the development of rapid reviews on this topic.
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http://dx.doi.org/10.1002/14651858.CD013812DOI Listing
December 2020

How can we adapt complex population health interventions for new contexts? Progressing debates and research priorities.

J Epidemiol Community Health 2021 01 27;75(1):40-45. Epub 2020 Sep 27.

Institute for Medical Information Processing, Biometry and Epidemiology, LMU Munich, Munich, Germany.

Introduction: The UK Medical Research Council and National Institute for Health Research have funded the ADAPT study (2018-2020), to develop methodological guidance for the adaptation of complex population health interventions for new contexts. While there have been advances in frameworks, there are key theoretical and methodological debates to progress. The ADAPT study convened a panel meeting to identify and enrich these debates. This paper presents the panel's discussions and suggests directions for future research.

Methods: Sixteen researchers and one policymaker convened for a 1-day meeting in July 2019. The aim was to reflect on emerging study findings (systematic review of adaptation guidance; scoping review of case examples; and qualitative interviews with funders, journal editors, researchers and policymakers), progress theoretical and methodological debates, and consider where innovation may be required to address research gaps.

Discussion: Despite the proliferation of adaptation frameworks, questions remain over the definition of basic concepts (eg, adaptation). The rationale for adaptation, which often focuses on differences between contexts, may lead to adaptation hyperactivity. Equal emphasis should be placed on similarities. Decision-making about intervention modification currently privileges the concept of 'core components', and work is needed to progress the use and operationalisation of 'functional fidelity'. Language and methods must advance to ensure meaningful engagement with diverse stakeholders in adaptation processes. Further guidance is required to assess the extent of re-evaluation required in the new context. A better understanding of different theoretical perspectives, notably complex systems thinking, implementation science and realist evaluation may help in enhancing research on adaptation.
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http://dx.doi.org/10.1136/jech-2020-214468DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7788480PMC
January 2021

Use of the GRADE approach in health policymaking and evaluation: a scoping review of nutrition and physical activity policies.

Implement Sci 2020 05 24;15(1):37. Epub 2020 May 24.

Institute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.

Background: Nutrition and physical activity policies have the potential to influence lifestyle patterns and reduce the burden of non-communicable diseases. In the world of health-related guidelines, GRADE (Grading of Recommendations, Assessment, Development and Evaluation) is the most widely used approach for assessing the certainty of evidence and determining the strength of recommendations. Thus, it is relevant to explore its usefulness also in the process of nutrition and physical activity policymaking and evaluation. The purpose of this scoping review was (i) to generate an exemplary overview of documents using the GRADE approach in the process of nutrition and physical activity policymaking and evaluation, (ii) to find out how the GRADE approach has been applied, and (iii) to explore which facilitators of and barriers to the use of GRADE have been described on the basis of the identified documents. The overarching aim of this work is to work towards improving the process of evidence-informed policymaking in the areas of dietary behavior, physical activity, and sedentary behavior.

Methods: A scoping review was conducted according to current reporting standards. MEDLINE via Ovid, the Cochrane Library, and Web of Science were systematically searched up until 4 July 2019. Documents describing a body of evidence which was assessed for the development or evaluation of a policy, including documents labeled as "guidelines," or systematic reviews used to inform policymaking were included.

Results: Thirty-six documents were included. Overall, 313 GRADE certainty of evidence ratings were identified in systematic reviews and guidelines; the strength of recommendations/policies was assessed in four documents, and six documents mentioned facilitators or barriers for the use of GRADE. The major reported barrier was the initial low starting level of a body of evidence from non-randomized studies when assessing the certainty of evidence.

Conclusion: This scoping review found that the GRADE approach has been used for policy evaluations, in the evaluation of the effectiveness of policy-relevant interventions (policymaking), as well as in the development of guidelines intended to guide policymaking. Several areas for future research were identified to explore the use of GRADE in health policymaking and evaluation.
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http://dx.doi.org/10.1186/s13012-020-00984-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7245872PMC
May 2020

Considerations of complexity in rating certainty of evidence in systematic reviews: a primer on using the GRADE approach in global health.

BMJ Glob Health 2019 25;4(Suppl 1):e000848. Epub 2019 Jan 25.

Institute for Medical Information Processing, Biometry and Epidemiology, Pettenkofer School of Public Health, Ludwig Maximilian University, Munich, Germany.

Public health interventions and health technologies are commonly described as 'complex', as they involve multiple interacting components and outcomes, and their effects are largely influenced by contextual interactions and system-level processes. Systematic reviewers and guideline developers evaluating the effects of these complex interventions and technologies report difficulties in using existing methods and frameworks, such as the Grading of Recommendations Assessment, Development and Evaluation (GRADE). As part of a special series of papers on implications of complexity in the WHO guideline development, this paper serves as a primer on how to consider sources of complexity when using the GRADE approach to rate certainty of evidence. Relevant sources of complexity in systematic reviews, health technology assessments and guidelines of public health are outlined and mapped onto the reported difficulties in rating the estimates of the effect of these interventions. Recommendations on how to address these difficulties are further outlined, and the need for an integrated use of GRADE from the beginning of the review or guideline development is emphasised. The content of this paper is informed by the existing GRADE guidance, an ongoing research project on considering sources of complexity when applying the GRADE approach to rate certainty of evidence in systematic reviews and the review authors' own experiences with using GRADE.
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http://dx.doi.org/10.1136/bmjgh-2018-000848DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6350753PMC
January 2019

Rating the quality of a body of evidence on the effectiveness of health and social interventions: A systematic review and mapping of evidence domains.

Res Synth Methods 2018 Jun 2;9(2):224-242. Epub 2018 Mar 2.

Department of Social Policy, Sociology and Criminology, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.

Introduction: Rating the quality of a body of evidence is an increasingly common component of research syntheses on intervention effectiveness. This study sought to identify and examine existing systems for rating the quality of a body of evidence on the effectiveness of health and social interventions.

Methods: We used a multicomponent search strategy to search for full-length reports of systems for rating the quality of a body of evidence on the effectiveness of health and social interventions published in English from 1995 onward. Two independent reviewers extracted data from each eligible system on the evidence domains included, as well as the development and dissemination processes for each system.

Results: Seventeen systems met our eligibility criteria. Across systems, we identified 13 discrete evidence domains: study design, study execution, consistency, measures of precision, directness, publication bias, magnitude of effect, dose-response, plausible confounding, analogy, robustness, applicability, and coherence. We found little reporting of rigorous procedures in the development and dissemination of evidence rating systems.

Conclusion: We identified 17 systems for rating the quality of a body of evidence on intervention effectiveness across health and social policy. Existing systems vary greatly in the domains they include and how they operationalize domains, and most have important limitations in their development and dissemination. The construct of the quality of the body of evidence was defined in a few systems largely extending the Grading of Recommendations Assessment, Development, and Evaluation approach. Grading of Recommendations Assessment, Development, and Evaluation was found to be unique in its comprehensive guidance, rigorous development, and dissemination strategy.
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http://dx.doi.org/10.1002/jrsm.1290DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6001464PMC
June 2018

A harmonized guidance is needed on how to "properly" frame review questions to make the best use of all available evidence in the assessment of effectiveness of complex interventions.

J Clin Epidemiol 2016 09 21;77:139-141. Epub 2016 Apr 21.

Department of Social Policy and Intervention, Centre for Evidence-Based Intervention, University of Oxford, Barnett House, 32 Wellington Square, Oxford OX1 2ER, UK.

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http://dx.doi.org/10.1016/j.jclinepi.2016.04.003DOI Listing
September 2016

Outcomes in systematic reviews of complex interventions never reached "high" GRADE ratings when compared with those of simple interventions.

J Clin Epidemiol 2016 10 30;78:22-33. Epub 2016 Mar 30.

Centre for Evidence-Based Intervention, Department of Social Policy and Intervention, University of Oxford, Barnett House, 32 Wellington Square, Oxford OX1 2ER, UK.

Objectives: To investigate the application of the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach and the quality of evidence ratings in systematic reviews of complex interventions.

Study Design And Setting: This study examined all 40 systematic reviews published in three Cochrane Review Groups from 2013 to May 2014: Cochrane Developmental, Psychosocial and Learning Problems Group (CDPLPG); Cochrane Public Health Group (CPHG); and Cochrane Depression, Anxiety, and Neurosis Group (CCDAN). The reviews were coded and classified into "complex" (n = 24) and "simple" (n = 16) intervention review groups based on the predefined complexity dimensions from the extant literature mapped into the PICOTS framework. All the data were analyzed in these two groups to help identify specific patterns of the GRADE ratings in the reviews of complex interventions.

Results: Outcomes of complex intervention reviews had higher proportions of "very low" quality of evidence ratings compared with those of simple intervention reviews (37.5% vs. 9.1% for the primary benefit outcomes) and were more frequently downgraded for inconsistency, performance bias, and study design. None of the outcomes of complex intervention reviews (0%) were given "high" GRADE ratings.

Conclusion: Results suggest that the GRADE assessment may not adequately describe the evidence base of complex interventions.
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http://dx.doi.org/10.1016/j.jclinepi.2016.03.014DOI Listing
October 2016

Users identified challenges in applying GRADE to complex interventions and suggested an extension to GRADE.

J Clin Epidemiol 2016 Feb 18;70:191-9. Epub 2015 Sep 18.

Centre for Evidence Based Intervention, Department of Social Policy and Intervention, University of Oxford, Barnett House, 32 Wellington Square, Oxford OX1 2ER, UK.

Objectives: To explore user perspectives on applying the Grading of Recommendations Assessment, Development and Evaluation (GRADE) to systematic reviews of complex interventions.

Study Design And Setting: Thirty-three authors of recent (2013 onward) systematic reviews were contacted regarding their perspectives on using GRADE from three Cochrane review groups: Cochrane Developmental, Psychosocial, and Learning Problems Group; Cochrane Public Health Group; and Cochrane Depression, Anxiety, and Neurosis Group. Framework Analysis was applied to the data to identify the challenges in applying GRADE and suggestions for its extension, that is, adaptation. These two themes were cross-compared between the groups of answers from "simple" vs. "complex" intervention review authors to identify the specific perspectives on using GRADE in reviews of complex interventions.

Results: Specific challenges were identified in applying GRADE to reviews of complex interventions. These were related to the assessment of nonrandomized studies and performance bias in GRADE. Authors perceived these challenges to contribute to frequent downgrading of the "best evidence possible" for complex interventions. Meanwhile, GRADE was found to lack an analytic approach to enable adequate evidence synthesis and assessment of intervention implementation elements.

Conclusion: Users suggest that the GRADE guidance be extended to address-specific considerations for complex interventions.
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http://dx.doi.org/10.1016/j.jclinepi.2015.09.010DOI Listing
February 2016
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