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Ultrasound in Obstetrics & Gynecology :... Apr 2023To determine, by expert consensus through a modified Delphi process, the role of standardized and new ultrasound signs in the prenatal evaluation of patients at high...
OBJECTIVE
To determine, by expert consensus through a modified Delphi process, the role of standardized and new ultrasound signs in the prenatal evaluation of patients at high risk of placenta accreta spectrum (PAS).
METHODS
A systematic review of articles providing information on ultrasound imaging signs or markers associated with PAS was performed before the development of questionnaires for the first round of the Delphi process. Only peer-reviewed original research studies in the English language describing one or more new ultrasound sign(s) for the prenatal evaluation of PAS were included. A three-round consensus-building Delphi method was then conducted under the guidance of a steering group, which included nine experts who invited an international panel of experts in obstetric ultrasound imaging in the evaluation of patients at high risk for PAS. Consensus was defined as agreement of ≥ 70% between participants.
RESULTS
The systematic review identified 15 articles describing eight new ultrasound signs for the prenatal evaluation of PAS. A total of 35 external experts were approached, of whom 31 agreed and participated in the first round. Thirty external experts (97%) and seven experts from the steering group completed all three Delphi rounds. A consensus was reached that a prior history of at least one Cesarean delivery, myomectomy or PAS should be an indication for detailed PAS ultrasound assessment. The panelists also reached a consensus that seven of the 11 conventional signs of PAS should be included in the examination of high-risk patients and the routine mid-gestation scan report: (1) loss of the 'clear zone', (2) myometrial thinning, (3) bladder-wall interruption, (4) placental bulge, (5) uterovesical hypervascularity, (6) placental lacunae and (7) bridging vessels. A consensus was not reached for any of the eight new signs identified by the systematic review. With respect to other ultrasound features that are not specific to PAS but increase the probability of PAS at birth, the panelists reached a consensus for the finding of anterior placenta previa or placenta previa with cervical involvement. The experts were also asked to determine which PAS signs should be quantified and consensus was reached only for the quantification of placental lacunae using an existing score. For predicting surgical outcome in patients with a high probability of PAS at delivery, a consensus was obtained for loss of the clear zone, bladder-wall interruption, presence of placental lacunae and presence of placenta previa involving the cervix.
CONCLUSIONS
We have confirmed the continued importance of seven established standardized ultrasound signs of PAS, highlighted the role of transvaginal ultrasound in evaluating the placental position and anatomy of the cervix, and identified new ultrasound signs that may become useful in the future prenatal evaluation and management of patients at high risk for PAS at birth. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
Topics: Infant, Newborn; Pregnancy; Female; Humans; Placenta Accreta; Placenta; Placenta Previa; Delphi Technique; Ultrasonography; Ultrasonography, Prenatal; Retrospective Studies
PubMed: 36609827
DOI: 10.1002/uog.26155 -
Medicine Dec 2022Congenital muscular torticollis (CMT) is the third most common musculoskeletal disease in children. With no standardized treatment method hence, so it is necessary to... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Congenital muscular torticollis (CMT) is the third most common musculoskeletal disease in children. With no standardized treatment method hence, so it is necessary to find an effective treatment method that can be received comfortably by children. This review assessed the efficacy of an external treatment of herbal medicine (ETHM) with tuina for CMT in children.
METHODS
This study searched the English, Chinese, and Korean databases (total of 10) until June 7 2022, without any language restrictions. All included studies were randomized clinical trials (RCTs) of ETHM with tuina as an intervention comparted to the same tuina alone according to the inclusion and exclusion criteria. The mean differences (MD), standardized mean differences (SMD), risk ratio (RR) with the 95% confidence interval (CI), and risk of bias (ROBs) were calculated using Review Manager Version 5.4 software. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) rating system was used to assess the quality of evidence. The publication bias was evaluated using a funnel plot, the Egger test, the fail-safe N test, and the Duval and Tweedle's trim and fill method using Review Manager Version 5.4 software, the software R Version 4.1.1 and R studio Version 1.4.1106 program.
RESULTS
Nineteen RCTs with 1710 patients were included in the meta-analysis. ETHM plus tuina improved the outcomes of the total effective rate (TER) [RR 1.21, 95% CI:1.15 to 1.26, P < .001], sternocleidomastoid (SCM) muscle thickness [MD: -1.82, 95% CI: -2.23 to -1.41, P < .001], cervical rotation range [MD: 13.43, 95% CI: 10.41-16.45, P < .001] and lateral flexion range [MD: 8.50, 95% CI: 6.15-10.85, P < .001], tissue elasticity grade [SMD: -0.46; 95% CI: -0.71 to -0.22, P = .0002], muscle elasticity scores [RR: 1.56; 95% CI: 1.04 to 2.34, P = .03], and clinical symptom and sign scores [SMD: -0.78; 95% CI: -1.09 to -0.47, P < .001].
CONCLUSIONS
ETHM plus tuina have a combined effect on CMT children. However, further studies with high-quality clinical trials are needed to obtain more robust clinical evidence.
Topics: Child; Humans; Plant Extracts
PubMed: 36482534
DOI: 10.1097/MD.0000000000032086 -
Heliyon Nov 2022Covid-19 vaccines have been assessed in randomized trials, which are designed to establish efficacy and safety, but are insufficient in power to detect rare adverse... (Review)
Review
INTRODUCTION
Covid-19 vaccines have been assessed in randomized trials, which are designed to establish efficacy and safety, but are insufficient in power to detect rare adverse outcomes. Among the adverse cardiac events associated with mRNA COVID-19 vaccines are inflammations (e.g., pericarditis or myocarditis), thrombosis, and ischemia.
OBJECTIVE
This systematic review aims to evaluate the reported cases of myocardial infarction (MI) after COVID-19 vaccinations.
METHOD
Web of Science, MEDLINE on OVID, PubMed, and Google Scholar were searched for English-language papers published until March 25, 2022.
RESULTS
This study included 15 papers (10 case reports and 5 case series). In total, 20 individuals were included who had received COVID-19 vaccines and experienced MI. Males (55%) reported more adverse occurrences than females (45%) across the majority of event categories. The mean time from the administration of the vaccine to the onset of symptoms was 2 days (0-10 days). The AstraZeneca vaccine was responsible for more than half of the reported events. In the majority of cases, the event developed after receiving the first dose of vaccination.
CONCLUSION
MI related to COVID19 vaccination is a rare, but serious and life-threatening condition. Chest discomfort should be regarded as a warning sign, particularly in people who have been administered a dose of the vaccine within the previous two days.
PubMed: 36406668
DOI: 10.1016/j.heliyon.2022.e11385 -
The Cochrane Database of Systematic... Feb 2022Description of the condition Malaria, an infectious disease transmitted by the bite of female mosquitoes from several Anopheles species, occurs in 87 countries with... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Description of the condition Malaria, an infectious disease transmitted by the bite of female mosquitoes from several Anopheles species, occurs in 87 countries with ongoing transmission (WHO 2020). The World Health Organization (WHO) estimated that, in 2019, approximately 229 million cases of malaria occurred worldwide, with 94% occurring in the WHO's African region (WHO 2020). Of these malaria cases, an estimated 409,000 deaths occurred globally, with 67% occurring in children under five years of age (WHO 2020). Malaria also negatively impacts the health of women during pregnancy, childbirth, and the postnatal period (WHO 2020). Sulfadoxine/pyrimethamine (SP), an antifolate antimalarial, has been widely used across sub-Saharan Africa as the first-line treatment for uncomplicated malaria since it was first introduced in Malawi in 1993 (Filler 2006). Due to increasing resistance to SP, in 2000 the WHO recommended that one of several artemisinin-based combination therapies (ACTs) be used instead of SP for the treatment of uncomplicated malaria caused by Plasmodium falciparum (Global Partnership to Roll Back Malaria 2001). However, despite these recommendations, SP continues to be advised for intermittent preventive treatment in pregnancy (IPTp) and intermittent preventive treatment in infants (IPTi), whether the person has malaria or not (WHO 2013). Description of the intervention Folate (vitamin B9) includes both naturally occurring folates and folic acid, the fully oxidized monoglutamic form of the vitamin, used in dietary supplements and fortified food. Folate deficiency (e.g. red blood cell (RBC) folate concentrations of less than 305 nanomoles per litre (nmol/L); serum or plasma concentrations of less than 7 nmol/L) is common in many parts of the world and often presents as megaloblastic anaemia, resulting from inadequate intake, increased requirements, reduced absorption, or abnormal metabolism of folate (Bailey 2015; WHO 2015a). Pregnant women have greater folate requirements; inadequate folate intake (evidenced by RBC folate concentrations of less than 400 nanograms per millilitre (ng/mL), or 906 nmol/L) prior to and during the first month of pregnancy increases the risk of neural tube defects, preterm delivery, low birthweight, and fetal growth restriction (Bourassa 2019). The WHO recommends that all women who are trying to conceive consume 400 micrograms (µg) of folic acid daily from the time they begin trying to conceive through to 12 weeks of gestation (WHO 2017). In 2015, the WHO added the dosage of 0.4 mg of folic acid to the essential drug list (WHO 2015c). Alongside daily oral iron (30 mg to 60 mg elemental iron), folic acid supplementation is recommended for pregnant women to prevent neural tube defects, maternal anaemia, puerperal sepsis, low birthweight, and preterm birth in settings where anaemia in pregnant women is a severe public health problem (i.e. where at least 40% of pregnant women have a blood haemoglobin (Hb) concentration of less than 110 g/L). How the intervention might work Potential interactions between folate status and malaria infection The malaria parasite requires folate for survival and growth; this has led to the hypothesis that folate status may influence malaria risk and severity. In rhesus monkeys, folate deficiency has been found to be protective against Plasmodium cynomolgi malaria infection, compared to folate-replete animals (Metz 2007). Alternatively, malaria may induce or exacerbate folate deficiency due to increased folate utilization from haemolysis and fever. Further, folate status measured via RBC folate is not an appropriate biomarker of folate status in malaria-infected individuals since RBC folate values in these individuals are indicative of both the person's stores and the parasite's folate synthesis. A study in Nigeria found that children with malaria infection had significantly higher RBC folate concentrations compared to children without malaria infection, but plasma folate levels were similar (Bradley-Moore 1985). Why it is important to do this review The malaria parasite needs folate for survival and growth in humans. For individuals, adequate folate levels are critical for health and well-being, and for the prevention of anaemia and neural tube defects. Many countries rely on folic acid supplementation to ensure adequate folate status in at-risk populations. Different formulations for folic acid supplements are available in many international settings, with dosages ranging from 400 µg to 5 mg. Evaluating folic acid dosage levels used in supplementation efforts may increase public health understanding of its potential impacts on malaria risk and severity and on treatment failures. Examining folic acid interactions with antifolate antimalarial medications and with malaria disease progression may help countries in malaria-endemic areas determine what are the most appropriate lower dose folic acid formulations for at-risk populations. The WHO has highlighted the limited evidence available and has indicated the need for further research on biomarkers of folate status, particularly interactions between RBC folate concentrations and tuberculosis, human immunodeficiency virus (HIV), and antifolate antimalarial drugs (WHO 2015b). An earlier Cochrane Review assessed the effects and safety of iron supplementation, with or without folic acid, in children living in hyperendemic or holoendemic malaria areas; it demonstrated that iron supplementation did not increase the risk of malaria, as indicated by fever and the presence of parasites in the blood (Neuberger 2016). Further, this review stated that folic acid may interfere with the efficacy of SP; however, the efficacy and safety of folic acid supplementation on these outcomes has not been established. This review will provide evidence on the effectiveness of daily folic acid supplementation in healthy and malaria-infected individuals living in malaria-endemic areas. Additionally, it will contribute to achieving both the WHO Global Technical Strategy for Malaria 2016-2030 (WHO 2015d), and United Nations Sustainable Development Goal 3 (to ensure healthy lives and to promote well-being for all of all ages) (United Nations 2021), and evaluating whether the potential effects of folic acid supplementation, at different doses (e.g. 0.4 mg, 1 mg, 5 mg daily), interferes with the effect of drugs used for prevention or treatment of malaria.
OBJECTIVES
To examine the effects of folic acid supplementation, at various doses, on malaria susceptibility (risk of infection) and severity among people living in areas with various degrees of malaria endemicity. We will examine the interaction between folic acid supplements and antifolate antimalarial drugs. Specifically, we will aim to answer the following. Among uninfected people living in malaria endemic areas, who are taking or not taking antifolate antimalarials for malaria prophylaxis, does taking a folic acid-containing supplement increase susceptibility to or severity of malaria infection? Among people with malaria infection who are being treated with antifolate antimalarials, does folic acid supplementation increase the risk of treatment failure?
METHODS
Criteria for considering studies for this review Types of studies Inclusion criteria Randomized controlled trials (RCTs) Quasi-RCTs with randomization at the individual or cluster level conducted in malaria-endemic areas (areas with ongoing, local malaria transmission, including areas approaching elimination, as listed in the World Malaria Report 2020) (WHO 2020) Exclusion criteria Ecological studies Observational studies In vivo/in vitro studies Economic studies Systematic literature reviews and meta-analyses (relevant systematic literature reviews and meta-analyses will be excluded but flagged for grey literature screening) Types of participants Inclusion criteria Individuals of any age or gender, living in a malaria endemic area, who are taking antifolate antimalarial medications (including but not limited to sulfadoxine/pyrimethamine (SP), pyrimethamine-dapsone, pyrimethamine, chloroquine and proguanil, cotrimoxazole) for the prevention or treatment of malaria (studies will be included if more than 70% of the participants live in malaria-endemic regions) Studies assessing participants with or without anaemia and with or without malaria parasitaemia at baseline will be included Exclusion criteria Individuals not taking antifolate antimalarial medications for prevention or treatment of malaria Individuals living in non-malaria endemic areas Types of interventions Inclusion criteria Folic acid supplementation Form: in tablet, capsule, dispersible tablet at any dose, during administration, or periodically Timing: during, before, or after (within a period of four to six weeks) administration of antifolate antimalarials Iron-folic acid supplementation Folic acid supplementation in combination with co-interventions that are identical between the intervention and control groups. Co-interventions include: anthelminthic treatment; multivitamin or multiple micronutrient supplementation; 5-methyltetrahydrofolate supplementation. Exclusion criteria Folate through folate-fortified water Folic acid administered through large-scale fortification of rice, wheat, or maize Comparators Placebo No treatment No folic acid/different doses of folic acid Iron Types of outcome measures Primary outcomes Uncomplicated malaria (defined as a history of fever with parasitological confirmation; acceptable parasitological confirmation will include rapid diagnostic tests (RDTs), malaria smears, or nucleic acid detection (i.e. polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP), etc.)) (WHO 2010). This outcome is relevant for patients without malaria, given antifolate antimalarials for malaria prophylaxis. Severe malaria (defined as any case with cerebral malaria or acute P. falciparum malaria, with signs of severity or evidence of vital organ dysfunction, or both) (WHO 2010). This outcome is relevant for patients without malaria, given antifolate antimalarials for malaria prophylaxis. Parasite clearance (any Plasmodium species), defined as the time it takes for a patient who tests positive at enrolment and is treated to become smear-negative or PCR negative. This outcome is relevant for patients with malaria, treated with antifolate antimalarials. Treatment failure (defined as the inability to clear malaria parasitaemia or prevent recrudescence after administration of antimalarial medicine, regardless of whether clinical symptoms are resolved) (WHO 2019). This outcome is relevant for patients with malaria, treated with antifolate antimalarials. Secondary outcomes Duration of parasitaemia Parasite density Haemoglobin (Hb) concentrations (g/L) Anaemia: severe anaemia (defined as Hb less than 70 g/L in pregnant women and children aged six to 59 months; and Hb less than 80 g/L in other populations); moderate anaemia (defined as Hb less than 100 g/L in pregnant women and children aged six to 59 months; and less than 110 g/L in others) Death from any cause Among pregnant women: stillbirth (at less than 28 weeks gestation); low birthweight (less than 2500 g); active placental malaria (defined as Plasmodium detected in placental blood by smear or PCR, or by Plasmodium detected on impression smear or placental histology). Search methods for identification of studies A search will be conducted to identify completed and ongoing studies, without date or language restrictions. Electronic searches A search strategy will be designed to include the appropriate subject headings and text word terms related to each intervention of interest and study design of interest (see Appendix 1). Searches will be broken down by these two criteria (intervention of interest and study design of interest) to allow for ease of prioritization, if necessary. The study design filters recommended by the Scottish Intercollegiate Guidelines Network (SIGN), and those designed by Cochrane for identifying clinical trials for MEDLINE and Embase, will be used (SIGN 2020). There will be no date or language restrictions. Non-English articles identified for inclusion will be translated into English. If translations are not possible, advice will be requested from the Cochrane Infectious Diseases Group and the record will be stored in the "Awaiting assessment" section of the review until a translation is available. The following electronic databases will be searched for primary studies. Cochrane Central Register of Controlled Trials. Cumulative Index to Nursing and Allied Health Literature (CINAHL). Embase. MEDLINE. Scopus. Web of Science (both the Social Science Citation Index and the Science Citation Index). We will conduct manual searches of ClinicalTrials.gov, the International Clinical Trials Registry Platform (ICTRP), and the United Nations Children's Fund (UNICEF) Evaluation and Research Database (ERD), in order to identify relevant ongoing or planned trials, abstracts, and full-text reports of evaluations, studies, and surveys related to programmes on folic acid supplementation in malaria-endemic areas. Additionally, manual searches of grey literature to identify RCTs that have not yet been published but are potentially eligible for inclusion will be conducted in the following sources. Global Index Medicus (GIM). African Index Medicus (AIM). Index Medicus for the Eastern Mediterranean Region (IMEMR). Latin American & Caribbean Health Sciences Literature (LILACS). Pan American Health Organization (PAHO). Western Pacific Region Index Medicus (WPRO). Index Medicus for the South-East Asian Region (IMSEAR). The Spanish Bibliographic Index in Health Sciences (IBECS) (ibecs.isciii.es/). Indian Journal of Medical Research (IJMR) (journals.lww.com/ijmr/pages/default.aspx). Native Health Database (nativehealthdatabase.net/). Scielo (www.scielo.br/). Searching other resources Handsearches of the five journals with the highest number of included studies in the last 12 months will be conducted to capture any relevant articles that may not have been indexed in the databases at the time of the search. We will contact the authors of included studies and will check reference lists of included papers for the identification of additional records. For assistance in identifying ongoing or unpublished studies, we will contact the Division of Nutrition, Physical Activity, and Obesity (DNPAO) and the Division of Parasitic Diseases and Malaria (DPDM) of the CDC, the United Nations World Food Programme (WFP), Nutrition International (NI), Global Alliance for Improved Nutrition (GAIN), and Hellen Keller International (HKI). Data collection and analysis Selection of studies Two review authors will independently screen the titles and abstracts of articles retrieved by each search to assess eligibility, as determined by the inclusion and exclusion criteria. Studies deemed eligible for inclusion by both review authors in the abstract screening phase will advance to the full-text screening phase, and full-text copies of all eligible papers will be retrieved. If full articles cannot be obtained, we will attempt to contact the authors to obtain further details of the studies. If such information is not obtained, we will classify the study as "awaiting assessment" until further information is published or made available to us. The same two review authors will independently assess the eligibility of full-text articles for inclusion in the systematic review. If any discrepancies occur between the studies selected by the two review authors, a third review author will provide arbitration. Each trial will be scrutinized to identify multiple publications from the same data set, and the justification for excluded trials will be documented. A PRISMA flow diagram of the study selection process will be presented to provide information on the number of records identified in the literature searches, the number of studies included and excluded, and the reasons for exclusion (Moher 2009). The list of excluded studies, along with their reasons for exclusion at the full-text screening phase, will also be created. Data extraction and management Two review authors will independently extract data for the final list of included studies using a standardized data specification form. Discrepancies observed between the data extracted by the two authors will be resolved by involving a third review author and reaching a consensus. Information will be extracted on study design components, baseline participant characteristics, intervention characteristics, and outcomes. For individually randomized trials, we will record the number of participants experiencing the event and the number analyzed in each treatment group or the effect estimate reported (e.g. risk ratio (RR)) for dichotomous outcome measures. For count data, we will record the number of events and the number of person-months of follow-up in each group. If the number of person-months is not reported, the product of the duration of follow-up and the number of children evaluated will be used to estimate this figure. We will calculate the rate ratio and standard error (SE) for each study. Zero events will be replaced by 0.5. We will extract both adjusted and unadjusted covariate incidence rate ratios if they are reported in the original studies. For continuous data, we will extract means (arithmetic or geometric) and a measure of variance (standard deviation (SD), SE, or confidence interval (CI)), percentage or mean change from baseline, and the numbers analyzed in each group. SDs will be computed from SEs or 95% CIs, assuming a normal distribution of the values. Haemoglobin values in g/dL will be calculated by multiplying haematocrit or packed cell volume values by 0.34, and studies reporting haemoglobin values in g/dL will be converted to g/L. In cluster-randomized trials, we will record the unit of randomization (e.g. household, compound, sector, or village), the number of clusters in the trial, and the average cluster size. The statistical methods used to analyze the trials will be documented, along with details describing whether these methods adjusted for clustering or other covariates. We plan to extract estimates of the intra-cluster correlation coefficient (ICC) for each outcome. Where results are adjusted for clustering, we will extract the treatment effect estimate and the SD or CI. If the results are not adjusted for clustering, we will extract the data reported. Assessment of risk of bias in included studies Two review authors (KSC, LFY) will independently assess the risk of bias for each included trial using the Cochrane 'Risk of bias 2' tool (RoB 2) for randomized studies (Sterne 2019). Judgements about the risk of bias of included studies will be made according to the recommendations outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2021). Disagreements will be resolved by discussion, or by involving a third review author. The interest of our review will be to assess the effect of assignment to the interventions at baseline. We will evaluate each primary outcome using the RoB2 tool. The five domains of the Cochrane RoB2 tool include the following. Bias arising from the randomization process. Bias due to deviations from intended interventions. Bias due to missing outcome data. Bias in measurement of the outcome. Bias in selection of the reported result. Each domain of the RoB2 tool comprises the following. A series of 'signalling' questions. A judgement about the risk of bias for the domain, facilitated by an algorithm that maps responses to the signalling questions to a proposed judgement. Free-text boxes to justify responses to the signalling questions and 'Risk of bias' judgements. An option to predict (and explain) the likely direction of bias. Responses to signalling questions elicit information relevant to an assessment of the risk of bias. These response options are as follows. Yes (may indicate either low or high risk of bias, depending on the most natural way to ask the question). Probably yes. Probably no. No. No information (may indicate no evidence of that problem or an absence of information leading to concerns about there being a problem). Based on the answer to the signalling question, a 'Risk of bias' judgement is assigned to each domain. These judgements include one of the following. High risk of bias Low risk of bias Some concerns To generate the risk of bias judgement for each domain in the randomized studies, we will use the Excel template, available at www.riskofbias.info/welcome/rob-2-0-tool/current-version-of-rob-2. This file will be stored on a scientific data website, available to readers. Risk of bias in cluster randomized controlled trials For the cluster randomized trials, we will be using the RoB2 tool to analyze the five standard domains listed above along with Domain 1b (bias arising from the timing of identification or recruitment of participants) and its related signalling questions. To generate the risk of bias judgement for each domain in the cluster RCTs, we will use the Excel template available at https://sites.google.com/site/riskofbiastool/welcome/rob-2-0-tool/rob-2-for-cluster-randomized-trials. This file will be stored on a scientific data website, available to readers. Risk of bias in cross-over randomized controlled trials For cross-over randomized trials, we will be using the RoB2 tool to analyze the five standard domains listed above along with Domain 2 (bias due to deviations from intended interventions), and Domain 3 (bias due to missing outcome data), and their respective signalling questions. To generate the risk of bias judgement for each domain in the cross-over RCTs, we will use the Excel template, available at https://sites.google.com/site/riskofbiastool/welcome/rob-2-0-tool/rob-2-for-crossover-trials, for each risk of bias judgement of cross-over randomized studies. This file will be stored on a scientific data website, available to readers. Overall risk of bias The overall 'Risk of bias' judgement for each specific trial being assessed will be based on each domain-level judgement. The overall judgements include the following. Low risk of bias (the trial is judged to be at low risk of bias for all domains). Some concerns (the trial is judged to raise some concerns in at least one domain but is not judged to be at high risk of bias for any domain). High risk of bias (the trial is judged to be at high risk of bias in at least one domain, or is judged to have some concerns for multiple domains in a way that substantially lowers confidence in the result). The 'risk of bias' assessments will inform our GRADE evaluations of the certainty of evidence for our primary outcomes presented in the 'Summary of findings' tables and will also be used to inform the sensitivity analyses; (see Sensitivity analysis). If there is insufficient information in study reports to enable an assessment of the risk of bias, studies will be classified as "awaiting assessment" until further information is published or made available to us. Measures of treatment effect Dichotomous data For dichotomous data, we will present proportions and, for two-group comparisons, results as average RR or odds ratio (OR) with 95% CIs. Ordered categorical data Continuous data We will report results for continuous outcomes as the mean difference (MD) with 95% CIs, if outcomes are measured in the same way between trials. Where some studies have reported endpoint data and others have reported change-from-baseline data (with errors), we will combine these in the meta-analysis, if the outcomes were reported using the same scale. We will use the standardized mean difference (SMD), with 95% CIs, to combine trials that measured the same outcome but used different methods. If we do not find three or more studies for a pooled analysis, we will summarize the results in a narrative form. Unit of analysis issues Cluster-randomized trials We plan to combine results from both cluster-randomized and individually randomized studies, providing there is little heterogeneity between the studies. If the authors of cluster-randomized trials conducted their analyses at a different level from that of allocation, and they have not appropriately accounted for the cluster design in their analyses, we will calculate the trials' effective sample sizes to account for the effect of clustering in data. When one or more cluster-RCT reports RRs adjusted for clustering, we will compute cluster-adjusted SEs for the other trials. When none of the cluster-RCTs provide cluster-adjusted RRs, we will adjust the sample size for clustering. We will divide, by the estimated design effects (DE), the number of events and number evaluated for dichotomous outcomes and the number evaluated for continuous outcomes, where DE = 1 + ((average cluster size 1) * ICC). The derivation of the estimated ICCs and DEs will be reported. We will utilize the intra-cluster correlation coefficient (ICC), derived from the trial (if available), or from another source (e.g., using the ICCs derived from other, similar trials) and then calculate the design effect with the formula provided in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2021). If this approach is used, we will report it and undertake sensitivity analysis to investigate the effect of variations in ICC. Studies with more than two treatment groups If we identify studies with more than two intervention groups (multi-arm studies), where possible we will combine groups to create a single pair-wise comparison or use the methods set out in the Cochrane Handbook to avoid double counting study participants (Higgins 2021). For the subgroup analyses, when the control group was shared by two or more study arms, we will divide the control group (events and total population) over the number of relevant subgroups to avoid double counting the participants. Trials with several study arms can be included more than once for different comparisons. Cross-over trials From cross-over trials, we will consider the first period of measurement only and will analyze the results together with parallel-group studies. Multiple outcome events In several outcomes, a participant might experience more than one outcome event during the trial period. For all outcomes, we will extract the number of participants with at least one event. Dealing with missing data We will contact the trial authors if the available data are unclear, missing, or reported in a format that is different from the format needed. We aim to perform a 'per protocol' or 'as observed' analysis; otherwise, we will perform a complete case analysis. This means that for treatment failure, we will base the analyses on the participants who received treatment and the number of participants for which there was an inability to clear malarial parasitaemia or prevent recrudescence after administration of an antimalarial medicine reported in the studies. Assessment of heterogeneity Heterogeneity in the results of the trials will be assessed by visually examining the forest plot to detect non-overlapping CIs, using the Chi2 test of heterogeneity (where a P value of less than 0.1 indicates statistical significance) and the I2 statistic of inconsistency (with a value of greater than 50% denoting moderate levels of heterogeneity). When statistical heterogeneity is present, we will investigate the reasons for it, using subgroup analysis. Assessment of reporting biases We will construct a funnel plot to assess the effect of small studies for the main outcome (when including more than 10 trials). Data synthesis The primary analysis will include all eligible studies that provide data regardless of the overall risk of bias as assessed by the RoB2 tool. Analyses will be conducted using Review Manager 5.4 (Review Manager 2020). Cluster-RCTs will be included in the main analysis after adjustment for clustering (see the previous section on cluster-RCTs). The meta-analysis will be performed using the Mantel-Haenszel random-effects model or the generic inverse variance method (when adjustment for clustering is performed by adjusting SEs), as appropriate. Subgroup analysis and investigation of heterogeneity The overall risk of bias will not be used as the basis in conducting our subgroup analyses. However, where data are available, we plan to conduct the following subgroup analyses, independent of heterogeneity. Dose of folic acid supplementation: higher doses (4 mg or more, daily) versus lower doses (less than 4 mg, daily). Moderate-severe anaemia at baseline (mean haemoglobin of participants in a trial at baseline below 100 g/L for pregnant women and children aged six to 59 months, and below 110 g/L for other populations) versus normal at baseline (mean haemoglobin above 100 g/L for pregnant women and children aged six to 59 months, and above 110 g/L for other populations). Antimalarial drug resistance to parasite: known resistance versus no resistance versus unknown/mixed/unreported parasite resistance. Folate status at baseline: Deficient (e.g. RBC folate concentration of less than 305 nmol/L, or serum folate concentration of less than 7nmol/L) and Insufficient (e.g. RBC folate concentration from 305 to less than 906 nmol/L, or serum folate concentration from 7 to less than 25 nmol/L) versus Sufficient (e.g. RBC folate concentration above 906 nmol/L, or serum folate concentration above 25 nmol/L). Presence of anaemia at baseline: yes versus no. Mandatory fortification status: yes, versus no (voluntary or none). We will only use the primary outcomes in any subgroup analyses, and we will limit subgroup analyses to those outcomes for which three or more trials contributed data. Comparisons between subgroups will be performed using Review Manager 5.4 (Review Manager 2020). Sensitivity analysis We will perform a sensitivity analysis, using the risk of bias as a variable to explore the robustness of the findings in our primary outcomes. We will verify the behaviour of our estimators by adding and removing studies with a high risk of bias overall from the analysis. That is, studies with a low risk of bias versus studies with a high risk of bias. Summary of findings and assessment of the certainty of the evidence For the assessment across studies, we will use the GRADE approach, as outlined in (Schünemann 2021). We will use the five GRADE considerations (study limitations based on RoB2 judgements, consistency of effect, imprecision, indirectness, and publication bias) to assess the certainty of the body of evidence as it relates to the studies which contribute data to the meta-analyses for the primary outcomes. The GRADEpro Guideline Development Tool (GRADEpro) will be used to import data from Review Manager 5.4 (Review Manager 2020) to create 'Summary of Findings' tables. The primary outcomes for the main comparison will be listed with estimates of relative effects, along with the number of participants and studies contributing data for those outcomes. These tables will provide outcome-specific information concerning the overall certainty of evidence from studies included in the comparison, the magnitude of the effect of the interventions examined, and the sum of available data on the outcomes we considered. We will include only primary outcomes in the summary of findings tables. For each individual outcome, two review authors (KSC, LFY) will independently assess the certainty of the evidence using the GRADE approach (Balshem 2011). For assessments of the overall certainty of evidence for each outcome that includes pooled data from included trials, we will downgrade the evidence from 'high certainty' by one level for serious (or by two for very serious) study limitations (risk of bias, indirectness of evidence, serious inconsistency, imprecision of effect estimates, or potential publication bias).
Topics: Child; Infant; Pregnancy; Infant, Newborn; Female; Humans; Child, Preschool; Antimalarials; Sulfadoxine; Pyrimethamine; Folic Acid Antagonists; Birth Weight; Parasitemia; Vitamins; Folic Acid; Anemia; Neural Tube Defects; Dietary Supplements; Iron; Recurrence
PubMed: 36321557
DOI: 10.1002/14651858.CD014217 -
JAMA Health Forum Aug 2021Inadequate access to food is a risk factor for poor health and the effectiveness of federal programs targeting food insecurity, such as the Supplemental Nutrition... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Inadequate access to food is a risk factor for poor health and the effectiveness of federal programs targeting food insecurity, such as the Supplemental Nutrition Assistance Program (SNAP), are well-documented. The associations between other types of interventions to provide adequate food access and food insecurity status, health outcomes, and health care utilization, however, are unclear.
OBJECTIVE
To review evidence on the association between food insecurity interventions and food insecurity status, clinically-relevant health outcomes, and health care utilization among adults, excluding SNAP.
DATA SOURCES
A systematic search for English-language literature was performed in PubMed Central and Cochrane Trials databases (inception to January 23, 2020), the Social Interventions Research and Evaluation Network database (December 10, 2019); and the gray literature using Google (February 1, 2021).
STUDY SELECTION
Studies of any design that assessed the association between food insecurity interventions for adult participants and food insecurity status, health outcomes, and health care utilization were screened for inclusion. Studies of interventions that described addressing participants' food needs or reporting food insecurity as an outcome were included. Interventions were categorized as home-delivered food, food offered at a secondary site, monetary assistance in the form of subsidies or income supplements, food desert interventions, and miscellaneous.
DATA EXTRACTION AND SYNTHESIS
Data extraction was performed independently by 3 reviewers. Study quality was assessed using the Cochrane Risk of Bias Tool, the ROBINS-I (Risk of Bias in Non-Randomized Studies of Interventions) tool, and a modified version of the National Institutes of Health's Quality Assessment Tool for Before-After Studies With No Control. The certainty of evidence was based on GRADE (Grading of Recommendations Assessment, Development, and Evaluation) criteria and supplemented with mechanistic and parallel evidence. For outcomes within intervention categories with at least 3 studies, random effects meta-analysis was performed.
MAIN OUTCOMES AND MEASURES
Food insecurity (measured through surveys; eg, the 2-item Hunger Vital Sign), health outcomes (eg, hemoglobin A), and health care utilization (eg, hospitalizations, costs).
RESULTS
A total of 39 studies comprising 170 605 participants were included (8 randomized clinical trials and 31 observational studies). Of these, 14 studies provided high-certainty evidence of an association between offering food and reduced food insecurity (pooled random effects; adjusted odds ratio, 0.53; 95% CI, 0.33-0.67). Ten studies provided moderate-certainty evidence of an association between offering monetary assistance and reduced food insecurity (pooled random effects; adjusted odds ratio, 0.64; 95% CI, 0.49-0.84). There were fewer studies of the associations between interventions and health outcomes or health care utilization, and the evidence in these areas was of low or very low certainty that any food insecurity interventions were associated with changes in either.
CONCLUSIONS AND RELEVANCE
This systematic review with meta-analysis found that providing food and monetary assistance was associated with improved food insecurity measures; however, whether it translated to better health outcomes or reduced health care utilization was unclear.
Topics: Adult; Dietary Supplements; Food Assistance; Food Insecurity; Hospitalization; Humans; Income; Randomized Controlled Trials as Topic; United States
PubMed: 35977189
DOI: 10.1001/jamahealthforum.2021.2001 -
Sensors (Basel, Switzerland) May 2022In recent years, noncontact measurements of vital signs using cameras received a great amount of interest. However, some questions are unanswered: (i) Which vital sign... (Review)
Review
In recent years, noncontact measurements of vital signs using cameras received a great amount of interest. However, some questions are unanswered: (i) Which vital sign is monitored using what type of camera? (ii) What is the performance and which factors affect it? (iii) Which health issues are addressed by camera-based techniques? Following the preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement, we conduct a systematic review of continuous camera-based vital sign monitoring using Scopus, PubMed, and the Association for Computing Machinery (ACM) databases. We consider articles that were published between January 2018 and April 2021 in the English language. We include five vital signs: heart rate (HR), respiratory rate (RR), blood pressure (BP), body skin temperature (BST), and oxygen saturation (SpO). In total, we retrieve 905 articles and screened them regarding title, abstract, and full text. One hundred and four articles remained: 60, 20, 6, 2, and 1 of the articles focus on HR, RR, BP, BST, and SpO, respectively, and 15 on multiple vital signs. HR and RR can be measured using red, green, and blue (RGB) and near-infrared (NIR) as well as far-infrared (FIR) cameras. So far, BP and SpO are monitored with RGB cameras only, whereas BST is derived from FIR cameras only. Under ideal conditions, the root mean squared error is around 2.60 bpm, 2.22 cpm, 6.91 mm Hg, 4.88 mm Hg, and 0.86 °C for HR, RR, systolic BP, diastolic BP, and BST, respectively. The estimated error for SpO is less than 1%, but it increases with movements of the subject and the camera-subject distance. Camera-based remote monitoring mainly explores intensive care, post-anaesthesia care, and sleep monitoring, but also explores special diseases such as heart failure. The monitored targets are newborn and pediatric patients, geriatric patients, athletes (e.g., exercising, cycling), and vehicle drivers. Camera-based techniques monitor HR, RR, and BST in static conditions within acceptable ranges for certain applications. The research gaps are large and heterogeneous populations, real-time scenarios, moving subjects, and accuracy of BP and SpO monitoring.
Topics: Aged; Blood Pressure; Child; Heart Rate; Humans; Infant, Newborn; Monitoring, Physiologic; Respiratory Rate; Vital Signs
PubMed: 35684717
DOI: 10.3390/s22114097 -
European Journal of Public Health Aug 2022d/Deaf people suffer from inequitable access to healthcare and health information. This results in worse health literacy and poorer mental and physical health compared...
BACKGROUND
d/Deaf people suffer from inequitable access to healthcare and health information. This results in worse health literacy and poorer mental and physical health compared to hearing populations. Various interventions aimed at improving health equity for d/Deaf people have been documented but not systematically analyzed. The purpose of this systematic review is to obtain a global overview of what we know about interventions aimed at improving health equity for d/Deaf people.
METHODS
Medline Ovid SP, Embase, CINAHL EBSCO, PsycINFO Ovid SP, Central-Cochrane Library Wiley and Web of Science were searched for relevant studies on access to healthcare and health-related interventions for d/Deaf people following the PRISMA-equity guidelines. We focused on interventions aimed at achieving equitable care and equitable access to health information for d/Deaf people.
RESULTS
Forty-six studies were identified and analyzed. Seven categories of interventions facing healthcare or health education inequities emerged: use of Sign Language (1), translation, validation and identification of clinical tools and scales (2), healthcare provider training program (3), development of adapted healthcare facilities (4), online interventions (5), education programs (6) and videos (7). Despite some methodological limitations or lack of data, these interventions seem relevant to improve equity of care and health education for d/Deaf people.
CONCLUSION
Interventions that promote healthcare equity, health education amongst d/Deaf patients and healthcare provider awareness of communication barriers and cultural sensitivity show promise in achieving more equitable care for d/Deaf patients. Meaningful engagement of d/Deaf individuals in the conceptualization, implementation and evaluation of health-related interventions is imperative.
Topics: Adult; Delivery of Health Care; Health Education; Health Equity; Health Personnel; Humans; Sign Language
PubMed: 35640159
DOI: 10.1093/eurpub/ckac056 -
The Cochrane Database of Systematic... May 2022Complex regional pain syndrome (CRPS) is a painful and disabling condition that usually manifests in response to trauma or surgery and is associated with significant... (Review)
Review
BACKGROUND
Complex regional pain syndrome (CRPS) is a painful and disabling condition that usually manifests in response to trauma or surgery and is associated with significant pain and disability. CRPS can be classified into two types: type I (CRPS I) in which a specific nerve lesion has not been identified and type II (CRPS II) where there is an identifiable nerve lesion. Guidelines recommend the inclusion of a variety of physiotherapy interventions as part of the multimodal treatment of people with CRPS. This is the first update of the review originally published in Issue 2, 2016.
OBJECTIVES
To determine the effectiveness of physiotherapy interventions for treating pain and disability associated with CRPS types I and II in adults.
SEARCH METHODS
For this update we searched CENTRAL (the Cochrane Library), MEDLINE, Embase, CINAHL, PsycINFO, LILACS, PEDro, Web of Science, DARE and Health Technology Assessments from February 2015 to July 2021 without language restrictions, we searched the reference lists of included studies and we contacted an expert in the field. We also searched additional online sources for unpublished trials and trials in progress.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) of physiotherapy interventions compared with placebo, no treatment, another intervention or usual care, or other physiotherapy interventions in adults with CRPS I and II. Primary outcomes were pain intensity and disability. Secondary outcomes were composite scores for CRPS symptoms, health-related quality of life (HRQoL), patient global impression of change (PGIC) scales and adverse effects.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened database searches for eligibility, extracted data, evaluated risk of bias and assessed the certainty of evidence using the GRADE system.
MAIN RESULTS
We included 16 new trials (600 participants) along with the 18 trials from the original review totalling 34 RCTs (1339 participants). Thirty-three trials included participants with CRPS I and one trial included participants with CRPS II. Included trials compared a diverse range of interventions including physical rehabilitation, electrotherapy modalities, cortically directed rehabilitation, electroacupuncture and exposure-based approaches. Most interventions were tested in small, single trials. Most were at high risk of bias overall (27 trials) and the remainder were at 'unclear' risk of bias (seven trials). For all comparisons and outcomes where we found evidence, we graded the certainty of the evidence as very low, downgraded due to serious study limitations, imprecision and inconsistency. Included trials rarely reported adverse effects. Physiotherapy compared with minimal care for adults with CRPS I One trial (135 participants) of multimodal physiotherapy, for which pain data were unavailable, found no between-group differences in pain intensity at 12-month follow-up. Multimodal physiotherapy demonstrated a small between-group improvement in disability at 12 months follow-up compared to an attention control (Impairment Level Sum score, 5 to 50 scale; mean difference (MD) -3.7, 95% confidence interval (CI) -7.13 to -0.27) (very low-certainty evidence). Equivalent data for pain were not available. Details regarding adverse events were not reported. Physiotherapy compared with minimal care for adults with CRPS II We did not find any trials of physiotherapy compared with minimal care for adults with CRPS II.
AUTHORS' CONCLUSIONS
The evidence is very uncertain about the effects of physiotherapy interventions on pain and disability in CRPS. This conclusion is similar to our 2016 review. Large-scale, high-quality RCTs with longer-term follow-up are required to test the effectiveness of physiotherapy-based interventions for treating pain and disability in adults with CRPS I and II.
Topics: Adult; Complex Regional Pain Syndromes; Electric Stimulation Therapy; Humans; Pain; Pain Measurement; Physical Therapy Modalities
PubMed: 35579382
DOI: 10.1002/14651858.CD010853.pub3 -
Frontiers in Psychology 2022The objective of this article was to review existing research to assess the evidence for predictive processing (PP) in sign language, the conditions under which it...
UNLABELLED
The objective of this article was to review existing research to assess the evidence for predictive processing (PP) in sign language, the conditions under which it occurs, and the effects of language mastery (sign language as a first language, sign language as a second language, bimodal bilingualism) on the neural bases of PP. This review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) framework. We searched peer-reviewed electronic databases (SCOPUS, Web of Science, PubMed, ScienceDirect, and EBSCO host) and gray literature (dissertations in ProQuest). We also searched the reference lists of records selected for the review and forward citations to identify all relevant publications. We searched for records based on five criteria (original work, peer-reviewed, published in English, research topic related to PP or neural entrainment, and human sign language processing). To reduce the risk of bias, the remaining two authors with expertise in sign language processing and a variety of research methods reviewed the results. Disagreements were resolved through extensive discussion. In the final review, 7 records were included, of which 5 were published articles and 2 were dissertations. The reviewed records provide evidence for PP in signing populations, although the underlying mechanism in the visual modality is not clear. The reviewed studies addressed the motor simulation proposals, neural basis of PP, as well as the development of PP. All studies used dynamic sign stimuli. Most of the studies focused on semantic prediction. The question of the mechanism for the interaction between one's sign language competence (L1 vs. L2 vs. bimodal bilingual) and PP in the manual-visual modality remains unclear, primarily due to the scarcity of participants with varying degrees of language dominance. There is a paucity of evidence for PP in sign languages, especially for frequency-based, phonetic (articulatory), and syntactic prediction. However, studies published to date indicate that Deaf native/native-like L1 signers predict linguistic information during sign language processing, suggesting that PP is an amodal property of language processing.
SYSTEMATIC REVIEW REGISTRATION
[https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021238911], identifier [CRD42021238911].
PubMed: 35496220
DOI: 10.3389/fpsyg.2022.805792 -
PeerJ. Computer Science 2022Humans communicate with one another using language systems such as written words or body language (movements), hand motions, head gestures, facial expressions, lip...
BACKGROUND AND OBJECTIVE
Humans communicate with one another using language systems such as written words or body language (movements), hand motions, head gestures, facial expressions, lip motion, and many more. Comprehending sign language is just as crucial as learning a natural language. Sign language is the primary mode of communication for those who have a deaf or mute impairment or are disabled. Without a translator, people with auditory difficulties have difficulty speaking with other individuals. Studies in automatic recognition of sign language identification utilizing machine learning techniques have recently shown exceptional success and made significant progress. The primary objective of this research is to conduct a literature review on all the work completed on the recognition of Urdu Sign Language through machine learning classifiers to date.
MATERIALS AND METHODS
All the studies have been extracted from databases, i.e., PubMed, IEEE, Science Direct, and Google Scholar, using a structured set of keywords. Each study has gone through proper screening criteria, , exclusion and inclusion criteria. PRISMA guidelines have been followed and implemented adequately throughout this literature review.
RESULTS
This literature review comprised 20 research articles that fulfilled the eligibility requirements. Only those articles were chosen for additional full-text screening that follows eligibility requirements for peer-reviewed and research articles and studies issued in credible journals and conference proceedings until July 2021. After other screenings, only studies based on Urdu Sign language were included. The results of this screening are divided into two parts; (1) a summary of all the datasets available on Urdu Sign Language. (2) a summary of all the machine learning techniques for recognizing Urdu Sign Language.
CONCLUSION
Our research found that there is only one publicly-available USL sign-based dataset with pictures versus many character-, number-, or sentence-based publicly available datasets. It was also concluded that besides SVM and Neural Network, no unique classifier is used more than once. Additionally, no researcher opted for an unsupervised machine learning classifier for detection. To the best of our knowledge, this is the first literature review conducted on machine learning approaches applied to Urdu sign language.
PubMed: 35494799
DOI: 10.7717/peerj-cs.883