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Environmental Health Perspectives Nov 2023There is a long tradition in environmental health of using frameworks for evidence synthesis, such as those of the U.S. Environmental Protection Agency for its...
BACKGROUND
There is a long tradition in environmental health of using frameworks for evidence synthesis, such as those of the U.S. Environmental Protection Agency for its Integrated Science Assessments and the International Agency for Research on Cancer Monographs. The framework, Grading of Recommendations Assessment, Development, and Evaluation (GRADE), was developed for evidence synthesis in clinical medicine. The U.S. Office of Health Assessment and Translation (OHAT) elaborated an approach for evidence synthesis in environmental health building on GRADE.
METHODS
We applied a modified OHAT approach and a broader "narrative" assessment to assess the level of confidence in a large systematic review on traffic-related air pollution and health outcomes.
DISCUSSION
We discuss several challenges with the OHAT approach and its implementation and suggest improvements for synthesizing evidence from observational studies in environmental health. We consider the determination of confidence using a formal rating scheme of up- and downgrading of certain factors, the treatment of every factor as equally important, and the lower initial confidence rating of observational studies to be fundamental issues in the OHAT approach. We argue that some observational studies can offer high-confidence evidence in environmental health. We note that heterogeneity in magnitude of effect estimates should generally not weaken the confidence in the evidence, and consistency of associations across study designs, populations, and exposure assessment methods may strengthen confidence in the evidence. We mention that publication bias should be explored beyond statistical methods and is likely limited when large and collaborative studies comprise most of the evidence and when accrued over several decades. We propose to identify possible key biases, their most likely direction, and their potential impacts on the results. We think that the OHAT approach and other GRADE-type frameworks require substantial modification to align better with features of environmental health questions and the studies that address them. We emphasize that a broader, "narrative" evidence assessment based on the systematic review may complement a formal GRADE-type evaluation. https://doi.org/10.1289/EHP11532.
Topics: Air Pollution; Environmental Health; Research Design; Observational Studies as Topic
PubMed: 37991444
DOI: 10.1289/EHP11532 -
Environment International Mar 2024The World Health Organization is coordinating an international project aimed at systematically reviewing the evidence regarding the association between radiofrequency... (Meta-Analysis)
Meta-Analysis
Effects of radiofrequency electromagnetic field (RF-EMF) exposure on male fertility: A systematic review of experimental studies on non-human mammals and human sperm in vitro.
BACKGROUND
The World Health Organization is coordinating an international project aimed at systematically reviewing the evidence regarding the association between radiofrequency electromagnetic field (RF-EMF) exposure and adverse health effects. Reproductive health outcomes have been identified among the priority topics to be addressed.
OBJECTIVES
To evaluate the effect of RF-EMF exposure on male fertility of experimental mammals and on human sperm exposed in vitro.
METHODS
Three electronic databases (PubMed, Scopus and EMF Portal) were last searched on September 17, 2022. Two independent reviewers screened the studies, which were considered eligible if met the following criteria: 1) Peer-reviewed publications of sham controlled experimental studies, 2) Non-human male mammals exposed at any stage of development or human sperm exposed in vitro, 3) RF-EMF exposure within the frequency range of 100 kHz-300 GHz, including electromagnetic pulses (EMP), 4) one of the following indicators of reproductive system impairment:Two reviewers extracted study characteristics and outcome data. We assessed risk of bias (RoB) using the Office of Health Assessment and Translation (OHAT) guidelines. We categorized studies into 3 levels of overall RoB: low, some or high concern. We pooled study results in a random effects meta-analysis comparing average exposure to no-exposure and in a dose-response meta-analysis using all exposure doses. For experimental animal studies, we conducted subgroup analyses for species, Specific Absorption Rate (SAR) and temperature increase. We grouped studies on human sperm exposed in vitro by the fertility status of sample donors and SAR. We assessed the certainty of the evidence using the GRADE approach after excluding studies that were rated as "high concern" for RoB.
RESULTS
One-hundred and seventeen papers on animal studies and 10 papers on human sperm exposed in vitro were included in this review. Only few studies were rated as "low concern" because most studies were at RoB for exposure and/or outcome assessment. Subgrouping the experimental animal studies by species, SAR, and temperature increase partly accounted for the heterogeneity of individual studies in about one third of the meta-analyses. In no case was it possible to conduct a subgroup analysis of the few human sperm in vitro studies because there were always 1 or more groups including less than 3 studies. Among all the considered endpoints, the meta-analyses of animal studies provided evidence of adverse effects of RF-EMF exposure in all cases but the rate of infertile males and the size of the sired litters. The assessment of certainty according to the GRADE methodology assigned a moderate certainty to the reduction of pregnancy rate and to the evidence of no-effect on litter size, a low certainty to the reduction of sperm count, and a very low certainty to all the other meta-analysis results. Studies on human sperm exposed in vitro indicated a small detrimental effect of RF-EMF exposure on vitality and no-effect on DNA/chromatin alterations. According to GRADE, a very low certainty was attributed to these results. The few studies that used EMP exposure did not show effects on the outcomes. A low to very low certainty was attributed to these results.
DISCUSSION
Many of the studies examined suffered of severe limitations that led to the attribution of uncertainty to the results of the meta-analyses and did not allow to draw firm conclusions on most of the endpoints. Nevertheless, the associations between RF-EMF exposure and decrease of pregnancy rate and sperm count, to which moderate and low certainty were attributed, are not negligible, also in view of the indications that in Western countries human male fertility potential seems to be progressively declining. It was beyond the scope of our systematic review to determine the shape of the dose-response relationship or to identify a minimum effective exposure level. The subgroup and the dose-response fitting analyses did not show a consistent relationship between the exposure levels and the observed effects. Notably, most studies evaluated RF-EMF exposure levels that were higher than the levels to which human populations are typically exposed, and the limits set in international guidelines. For these reasons we cannot provide suggestions to confirm or reconsider current human exposure limits. Considering the outcomes of this systematic review and taking into account the limitations found in several of the studies, we suggest that further investigations with better characterization of exposure and dosimetry including several exposure levels and blinded outcome assessment were conducted.
PROTOCOL REGISTRATION
Protocols for the systematic reviews of animal studies and of human sperm in vitro studies were published in Pacchierotti et al., 2021. The former was also registered in PROSPERO (CRD42021227729 https://www.crd.york.ac.uk/prospero/display_record.php?RecordID = 227729) and the latter in Open Science Framework (OSF Registration DOI https://doi.org/10.17605/OSF.IO/7MUS3).
Topics: Animals; Humans; Male; Electromagnetic Fields; Mammals; Radio Waves; Reproduction; Semen; Infertility, Male
PubMed: 38492496
DOI: 10.1016/j.envint.2024.108509 -
Epidemiologia E Prevenzione 2023the epidemiological surveillance programme carried out in the Italian Contaminated Sites (SENTIERI Project) is based on an a priori evaluation of the epidemiological...
BACKGROUND
the epidemiological surveillance programme carried out in the Italian Contaminated Sites (SENTIERI Project) is based on an a priori evaluation of the epidemiological evidence of a causal association between environmental exposures and health outcomes.
OBJECTIVES
to produce an updated review of the epidemiological evidence (January 2009-May 2020) on the association between environmental exposures and health outcomes predefined and published by the SENTIERI working group.
METHODS
a systematic review was conducted on MEDLINE, EMBASE, and Web of Science. Additional searches were conducted on the websites of relevant organizations. The sources of environmental exposure considered were the ones included in SENTIERI Projects (chemicals, petrochemicals and refineries, steel plants, power plants, port area, waste, mines and source of asbestos).
RESULTS
a total of 16,817 records were identified and, after the screening process, 14 systematic reviews were identified: two IARC Monograph, two WHO Reports, one WHO/UNEP Report, and 15 observational studies. Living in proximity of contaminated sites was associated with specific diseases (mortality or incidence), with a high heterogeneity across environmental sources. For some exposures, data suggests a gender differential effect for some causes of disease.
CONCLUSIONS
compared to a previous evidence evaluation, this systematic review shows a higher number of diseases associated with residential exposure to some contaminated sites (petrochemical facilities, waste, mines, and sources of asbestos). According to the results of this review, the a priori evidence evaluation was updated and used to interpret the epidemiological data of the Sixth SENTIERI Project Report.
Topics: Humans; Environmental Pollution; Italy; Environmental Exposure; Asbestos; Outcome Assessment, Health Care
PubMed: 36825374
DOI: 10.19191/EP23.1-2-S1.004 -
Acta Psychiatrica Scandinavica Dec 2020Recent meta-analyses on dose-response relationships of SSRIs are largely based on indirect evidence. We analyzed RCTs directly comparing different SSRI doses. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Recent meta-analyses on dose-response relationships of SSRIs are largely based on indirect evidence. We analyzed RCTs directly comparing different SSRI doses.
METHOD
Systematic literature search for RCTs. Two raters independently screened articles and extracted data. Across SSRIs, doses defined as low, medium, and high doses, based on drug manufacturers' product monographs, were analyzed in pairwise random-effects meta-analyses and in a sensitivity network meta-analysis with regard to differences in antidepressive efficacy (primary outcome). We also analyzed all direct comparisons of different dosages of specific SSRIs. (Prospero CRD42018081031).
RESULTS
Out of 5333 articles screened, we included 33. Comparisons of dosage groups (low, medium, and high) resulted in only small and clinically non-significant differences for SSRIs as a group, the strongest relating to medium vs low doses (SMD: -0.15 [95%-CI: -0.28; -0.01) and not sustained in a sensitivity analysis. Among different doses of specific SSRIs, no statistically significant trend emerged for efficacy at higher doses, but 60 mg/day fluoxetine are statistically significantly inferior to 20 mg/day. Paroxetine results are inconclusive: 10 mg/day are inferior to higher doses, but 30 and 40 mg/day are inferior to 20 mg/day. Meaningful effects cannot be ruled out for certain drugs and dosages, often investigated in only one trial. Dropout rates increase with dose-particularly due to side effects. Network meta-analyses supported our findings.
CONCLUSIONS
There is no conclusive level I or level II evidence of a clinically meaningful dose-response relationship of SSRIs as a group or of single substances. High SSRI doses are not recommended as routine treatment.
Topics: Depression; Dose-Response Relationship, Drug; Fluoxetine; Humans; Network Meta-Analysis; Paroxetine; Selective Serotonin Reuptake Inhibitors; Treatment Outcome
PubMed: 32970827
DOI: 10.1111/acps.13235 -
Expert Opinion on Drug Safety Sep 2020We systematically reviewed adverse events (AEs) for ocrelizumab for multiple sclerosis (MS).
INTRODUCTION
We systematically reviewed adverse events (AEs) for ocrelizumab for multiple sclerosis (MS).
AREAS COVERED
We searched Medline, Embase, Web of Science, and Toxicology Data Network-TOXLINE (inception to 8-July-2020), clinical trial registries, and product monographs for any clinical trials, observational studies or case reports examining AEs to ocrelizumab. Studies with/without a comparator drug or placebo were eligible.
EXPERT OPINION
Seventy-eight records were included (4 randomized controlled trials (RCTs), 4 open-label trials, 29 observational studies, and 27 case reports). AEs affected 2756/4498 (61.3%) of ocrelizumab-exposed patients. The most common AEs were infections (n=1342, 39.2% of ocrelizumab-exposed patients) and infusion-related reactions (n=1391, 26.2%). Compared to beta-interferon, infections were more likely in ocrelizumab-exposed patients (Risk Ratio (RR)=1.10; 95% confidence interval (CI):1.01-1.19), including: herpes-related (RR=1.75; 95%CI:1.11-2.76), respiratory tract-related (RR=1.42; 95%CI:1.10-1.84 and RR=1.61; 95%CI:1.10-2.35), nasopharyngitis (RR=1.47; 95%CI:1.13-1.90), and rhinitis (RR=4.00; 95%CI:1.13-14.14). Infusion-related reactions (RR range: 1.57-4.42) were more common for ocrelizumab versus placebo or beta-interferon. From pooled analyses (three RCTs), the risk of 'any' serious AE did not differ significantly between the ocrelizumab and comparator groups. However, insufficient data were available to assess longer-term AEs, e.g., malignancy.
Topics: Antibodies, Monoclonal, Humanized; Humans; Immunologic Factors; Multiple Sclerosis; Randomized Controlled Trials as Topic
PubMed: 32799563
DOI: 10.1080/14740338.2020.1807002 -
International Journal of Dentistry 2020People with disabilities tend to have greater oral health problems compared to those without disabilities. This may be due to barriers they come across in accessing...
BACKGROUND
People with disabilities tend to have greater oral health problems compared to those without disabilities. This may be due to barriers they come across in accessing dental services.
OBJECTIVES
The objective of this systematic review was to provide a critical digest of the scientific literature concerning barriers and facilitators of access to oral health services for people with disabilities.
METHODS
The electronic databases PubMed, Scopus, Web of Science, Latin American and Caribbean Health Sciences Literature (LILACS), and Brazilian Library of Dentistry (BBO) were searched using keywords relevant to the subject. The search was not restricted to specific languages or years of publication; all relevant studies were translated and reviewed.
RESULTS
Sixteen studies including 14 articles, a doctoral thesis, and a monograph were selected, and their quality was analysed using the Downs and Black assessment tool. Barriers to dental services were divided into physical or nonphysical based on the dentist's perspective, as per the perception of parents/guardians or by the persons with disabilities. The barriers that emerged included the dentist's lack of preparation to assist people with disabilities, structural problems of access to dental offices, communication difficulties, and lack of awareness regarding the need for dental treatment for the disabled person.
CONCLUSION
It is concluded that people with disabilities continue to run into complex physical, behavioural, or multidimensional barriers in accessing dental services. Improved training of dentists for the care of this population is hereby emphasized. The legal framework enabling access to dental care for people with disabilities must also be respected in each country.
PubMed: 32774378
DOI: 10.1155/2020/9074618 -
Reumatologia Clinica Dec 2022To analyse the role of nursing in the approach to axial spondyloarthritis (axSpA) and to make proposals to include the role of rheumatology nursing consultations (RECs)...
OBJECTIVE
To analyse the role of nursing in the approach to axial spondyloarthritis (axSpA) and to make proposals to include the role of rheumatology nursing consultations (RECs) in the quality certification of these specialized units.
METHODS
A systematic review of the nursing role in quality certification systems in the management of axSpA was conducted. Subsequently a consensus conference was held with the participation of three rheumatology nurses to determine elements that should be considered in future revisions of certification standards.
RESULTS
The systematic review yielded five papers as relevant. None of the publications reviewed explicitly proposed standards applicable to nursing care in the management of patients with axSpA, although they contemplated the activities of this professional group. The proposals agreed upon to incorporate the role of RECs in the certification standards for axSpA monographic units included the following: basic equipment and resources, organization, administration of pharmacological treatments and promotion of adherence, standardized programmes for axSpA, telematic consultation for monitoring the stable patient, registry of patient-reported outcome measures and e-consultation.
CONCLUSIONS
The literature on quality standards and certification standards for axSpA monographic units is scarce and hardly reflects the role of RECs in providing quality care. The consensus proposals in this study would incorporate RECs into quality certification standards. In the future, the increased presence of RECs in Spain should be accompanied by a review of the indicators regarding their role.
Topics: Humans; Spondylarthritis; Axial Spondyloarthritis; Rheumatology; Patient Reported Outcome Measures; Certification
PubMed: 35469782
DOI: 10.1016/j.reumae.2021.09.004 -
Health Communication Apr 2023The quest for a Viagra equivalent for women has both reignited concerns over female oppression and rekindled hope for gender equality. Communication about decreased...
The quest for a Viagra equivalent for women has both reignited concerns over female oppression and rekindled hope for gender equality. Communication about decreased desire in women has come under intense scrutiny, especially in terms of the ways in which it may legitimize one view or the other. We present a systematic review of academic research on public communication about low libido in women and drugs/devices designed to increase it. A total of 1,309 records were screened, with 20 studies identified for final analysis (6 monographs, 11 articles, and 3 book chapters). Existing research found that the frame predominated, according to which women sought to increase their libido of their own accord to enhance their individual sexual pleasure. The frame was described as somewhat less common; here, women resorted to treatment to save their relationships as they feared that inability to fulfill their "wifely duty" could alienate their partners. Importantly, scholars often reported that the empowered and handmaid frames co-occurred. The frame, which suggested fluctuations in libido were normal and should not be medically treated, was described in existing work as least common. These results seem to suggest that low libido in women was constructed as a problem in need of a solution more often than not. As this may prompt women to think of their bodies as malfunctioning machines, it is possible that the framing of low libido in public communication can exacerbate existing trends toward pathologizing the waning of desire.
Topics: Female; Humans; Libido; Communication; Sexual Behavior; Sexual Partners
PubMed: 34493138
DOI: 10.1080/10410236.2021.1971356 -
BMC Medical Research Methodology Feb 2024People with dementia are routinely included as research participants in trials and other quantitative studies in which they are invited to respond to standardised...
BACKGROUND
People with dementia are routinely included as research participants in trials and other quantitative studies in which they are invited to respond to standardised measures. This paper reviews the reporting of standardised data collection from people with dementia in reports published in the National Institute for Health and Care Research (NIHR) Journals Library. The aim was to understand how the administration of standardised, self-report measures with people with dementia is reported in NIHR monographs and what could be learnt from this about the feasibility and acceptability of data collection approaches for future studies.
METHODS
This was a systematic review with narrative synthesis. Broad search terms (Dementia OR Alzheimer*) were used to search the NIHR Journals Library website in December 2021. All studies that used (or intended to use) standardised measures to collect research data directly from people with dementia were eligible for inclusion. Information was extracted (where reported) on the process of data collection, dementia severity, levels of missing data and the experiences and reflections of those involved.
RESULTS
Searches returned 42 records, from which 17 reports were assessed as eligible for inclusion, containing 22 studies. Response rates from participants with dementia in these studies varied considerably and appeared to be related to dementia severity and place of residence. Little information was reported on the process of data collection or the reasons for missing data, and most studies did not report the experiences of participants or those administering the measures. However, there was an indication from two studies that standardised data collection could provoke emotional distress in some participants with dementia.
CONCLUSIONS
Through this review we identified both variation in levels of missing data and gaps in reporting which make it difficult to ascertain the reasons for this variation. We also identified potential risks to the well-being of participants with dementia which may be associated with the content of standardised measures and the context of data collection. Open reporting of and reflection upon data collection processes and the experiences of people involved is essential to ensure both the success of future data collection and the wellbeing of study participants.
TRIAL REGISTRATION
Registered with Research on Research https://ror-hub.org/study/2905/ .
Topics: Humans; Data Collection; Narration; Dementia
PubMed: 38365600
DOI: 10.1186/s12874-024-02148-y