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Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki, and approved by the Institutional Review Board (or Ethics Committee) of King’s College London (HR-17/18-5341; approval granted January 2018). | PMC9919979 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC9919979 | ||
Data Availability Statement | Data available on request. The data presented in this study are available on request from the corresponding author. The data are not publicly available due to nature of consent obtained from participants. | PMC9919979 | ||
Conflicts of Interest | IBS, TG | AC was funded by a PhD studentship funded by Almond Board of California. ED has received an education grant from Alpro, research funding from the British Dietetic Association, the Almond Board of California, the International Nut and Dried Fruit Council and Nestec Ltd. and has served as a consultant for Puratos. TG sup... | PMC9919979 | |
References | Consort diagram.Particle size distributions of masticated whole and ground almonds (Demographic characteristics of participants.Participant dentition.Data are number, Particle size distributions of masticated whole and ground almonds assessed by the mechanical sieving technique.Values are mean (SD) or mean difference (... | PMC9919979 | ||
Summary | PMC9860215 | |||
Background | POLIOMYELITIS | Type 2 circulating vaccine-derived polioviruses (cVDPV2) from Sabin oral poliovirus vaccines (OPVs) are the leading cause of poliomyelitis. A novel type 2 OPV (nOPV2) has been developed to be more genetically stable with similar tolerability and immunogenicity to that of Sabin type 2 vaccines to mitigate the risk of cV... | PMC9860215 | |
Methods | diarrhoea, infection, vomiting, immunodeficiency disorder | ADVERSE EVENTS, INFECTION, IMMUNODEFICIENCY DISORDER | In this randomised, double-blind, controlled, phase 2 trial we enrolled newborn infants at the Matlab Health Research Centre, Chandpur, Bangladesh. We included infants who were healthy and were a single birth after at least 37 weeks' gestation. Infants were randomly assigned (2:1) to receive either two doses of nOPV2 o... | PMC9860215 |
Findings | ADVERSE EVENTS | Between Sept 21, 2020, and Aug 16, 2021, we screened 334 newborn infants, of whom three (<1%) were found to be ineligible and one (<1%) was withdrawn by the parents; the remaining 330 (99%) infants were assigned to receive nOPV2 (n=220 [67%]) or placebo (n=110 [33%]). nOPV2 was well tolerated; 154 (70%) of 220 newborn ... | PMC9860215 | |
Interpretation | nOPV2 was well tolerated and immunogenic in newborn infants, with two doses, at birth and 4 weeks, resulting in almost 99% of infants having protective neutralising antibodies. | PMC9860215 | ||
Funding | Bill & Melinda Gates Foundation. | PMC9860215 | ||
Introduction | acute flaccid paralysis, poliomyelitis, vaccine-associated paralytic | POLIOMYELITIS, POLIO | Although live oral poliovirus vaccines (OPVs) are safe and effective and have led to the elimination of poliomyelitis from most of the world, in rare circumstances the attenuated viruses in OPVs can mutate and reacquire neurovirulence. This mutation can result in vaccine-associated paralytic polio in vaccine recipients... | PMC9860215 |
Research in context | infection | INFECTION, PARALYTIC POLIOMYELITIS, POLIO |
Outbreaks of circulating vaccine-derived poliovirus type 2 (cVDPV2) are now the main cause of paralytic poliomyelitis worldwide. A novel, genetically more stable monovalent type 2 oral polio vaccine that was developed for use in outbreak control with less inherent chance of propagating more cVDPV2 has been studied in ... | PMC9860215 |
Methods | PMC9860215 | |||
Study design and participants | diarrhoea, infection, vomiting, immunodeficiency disorder | INFECTION, DISEASE, IMMUNODEFICIENCY DISORDER | We did a randomised, double-blind, phase 2 clinical study at the Matlab Health Research Center in Chandpur, rural Bangladesh. The protocol was approved by the research review committee and the ethical review committee at the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b).Women in the third t... | PMC9860215 |
Randomisation and masking | Participants were randomly assigned (2:1) to either nOPV2 or placebo, using a block randomisation of size 6 or 12 generated by a statistician who was not otherwise involved in the study. The statistician prepared randomisation lists for study nurses or investigators who were masked to the allocation of the vaccine or p... | PMC9860215 | ||
Procedures | deaths, acute flaccid paralysis, vaccine-associated | VIRAL DISEASES, ADVERSE EVENTS, ENCEPHALITIS, POLIO, ASEPTIC MENINGITIS, ADVERSE EVENT, DISEASE, POLIO | Infants in the nOPV2 group received a vaccine (PT Bio Farma, Indonesia) composed of an attenuated serotype 2 poliovirus derived from a modified Sabin 2 infectious clone propagated in Vero cells.The first vaccine or placebo dose was given within a window of 0–3 days after birth and all participants received a second dos... | PMC9860215 |
Outcomes | ADVERSE EVENTS, DECAY, SECONDARY, VIRAL SHEDDING | The coprimary objectives were to assess the safety and tolerability, and the immunogenicity (measured by seroconversion rate) after one and two doses of nOPV2 when given 4 weeks apart in poliovirus vaccine-naive newborn infants. The secondary outcome was an assessment of the rate, duration, and extent of faecal viral s... | PMC9860215 | |
Statistical analysis | We selected a sample size of 220 participants in the nOPV2 group, with a placebo control group with half that number of participants (n=110), to provide sufficient power to assess the immunogenicity of the candidate vaccines on the basis of previous studies. In a study done in India in 2008, before the cessation of OPV... | PMC9860215 | ||
Role of the funding source | MH | Four authors, KZ, JDC, AGR, and MH, were employees of the study sponsor, and one, ASB, is employed by the study funder, who were involved in study design, data collection, and writing of the study report. | PMC9860215 | |
Results | pneumonia, hepatitis A/B, vomiting, watery diarrhoea, gastrointestinal disorders | PNEUMONIA, ADVERSE EVENTS, VIRAL SHEDDING, SECONDARY, GASTROINTESTINAL DISORDERS | Between Sept 21, 2020, and Aug 16, 2021, we screened 334 newborn infants, of whom three (<1%) were found to be ineligible and one (<1%) was withdrawn by the parents; the remaining 330 (99%) infants were assigned to the two study groups (220 [67%] assigned to nOPV2 and 110 [33%] to placebo; Trial profilenOPV2=novel oral... | PMC9860215 |
Discussion | VIRUS, ADVERSE EVENTS, EVENT, ADVERSE EVENT, EVENTS | We found similar tolerability profiles in the nOPV2 and placebo groups, with only mild solicited adverse events and no related serious adverse events or adverse events of special interest reported. Solicited adverse event rates after nOPV2 and placebo were higher after second doses than after first doses, representing ... | PMC9860215 | |
Data sharing | Data for this study will be made available to others in the scientific community upon request. Standard criteria for making data available for valid research projects will be used, following application by suitably qualified researchers. For data access, please contact the Bill & Melinda Gates Foundationat | PMC9860215 | ||
Declaration of interests | ET is a full-time employee of the vaccine manufacturer, PT Bio Farma (Bandung, Indonesia). All other authors declare no competing interests. | PMC9860215 | ||
References | PMC9860215 | |||
Supplementary Material | PMC9860215 | |||
Supplementary appendix | PMC9860215 | |||
Acknowledgments | icddr,b acknowledges the commitment of the Bill & Melinda Gates Foundation to its research efforts. icddr,b is also grateful to the Governments of Bangladesh, Canada, Sweden, and the UK for providing core or unrestricted support. The authors are grateful to all the parents and guardians of the infants who were enrolled... | PMC9860215 | ||
Contributors | MH | KZ, MH, CG, MY, KMJ, JDC, AGR, BAM, ET, and ASB participated in the conception and design of the study and contributed to the writing of the protocol. RC and SACC provided scientific advice for the protocol and interpretation of the results. MH, MY, and KMJ were investigators treating participants. CG performed all sta... | PMC9860215 | |
Background | GENERALISED CONVULSIVE STATUS EPILEPTICUS | Generalised convulsive status epilepticus (GCSE) is a medical emergency. Guidelines recommend a stepwise strategy of benzodiazepines followed by a second-line anti-seizure medicine (ASM). However, GCSE is uncontrolled in 20–40% patients and is associated with protracted hospitalisation, disability, and mortality. The o... | PMC9830759 | |
Methods | seizure | ADVERSE EVENTS, SECONDARY | This was a multicentre, double-blind, randomised controlled trial in 244 adults admitted to intensive care units for GCSE in 16 French hospitals between 2013 and 2018. Patients received standard care of benzodiazepine and a second-line ASM (except VPA). Intervention patients received a 30 mg/kg VPA loading dose, then a... | PMC9830759 |
Results | A total of 126 (52%) and 118 (48%) patients were included in the VPA and placebo groups. 224 (93%) and 227 (93%) received a first-line and a second-line ASM before VPA or placebo infusion. There was no between-group difference for patients hospital-discharged at day 15 [VPA, 77 (61%) | PMC9830759 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s13054-022-04292-7. | PMC9830759 | ||
Keywords | PMC9830759 | |||
Introduction | epileptic, seizures, convulsive seizure | EPILEPTIC, GENERALISED CONVULSIVE STATUS EPILEPTICUS | Generalised convulsive status epilepticus (GCSE) is a diagnostic and therapeutic emergency and is defined as a convulsive seizure lasting more than 5 min, or as consecutive seizures without recovery of consciousness between seizures [Experts therefore considered that interventions should be proposed as treatment adjunc... | PMC9830759 |
Methods | PMC9830759 | |||
Study design | STATUS EPILEPTICUS | VALSE (VALproic Acid in Status Epilepticus) is a multicentre, in parallel, randomised double-blind, controlled trial conducted in 16 French ICUs. It compared the addition of intravenous VPA with placebo in patients admitted to the ICU for GCSE, as well as to first- and second-line ASMs and standard ICU care. The overal... | PMC9830759 | |
Eligibility criteria | status epilepticus, seizures, convulsive seizure | STATUS EPILEPTICUS | Adult patients were eligible if admitted to the ICU for GCSE, defined by 5 min or more of continuous or recurrent generalised convulsive seizure without recovery of consciousness between seizures [Main exclusion criteria were non-convulsive status epilepticus clinically characterised by altered mental status but with n... | PMC9830759 |
Randomisation and interventions | seizures | Eligible patients were randomly assigned in a 1:1 ratio to receive either VPA or placebo. Randomisation, with stratification according to site, age, and presence of acute brain injury, was performed with the use of a central concealed, Web-based, automated randomisation system. VPA treatment consisted of intravenous ad... | PMC9830759 | |
Outcomes and assessment | super-refractory, abnormal movements, seizure | ADVERSE EVENTS, RECURRENCE | The primary outcome was the proportion of living patients discharged from hospital to their home or to a long-term care facility on day 15. The primary endpoint (i.e. hospital status at day 15) was collected by a local investigator, blinded to group assignment (Additional file Secondary outcomes were recurrence of seiz... | PMC9830759 |
Statistical analysis | REGRESSION, SECONDARY | The study was powered to detect an absolute increase of 20% in the rate of patients discharged alive at day 15 with a power of 90% and a two-sided 0.05 significance level, assuming a 50% rate in the control group. Accordingly, the sample size was 124 patients per group. To account for potential errors in the administra... | PMC9830759 | |
Anti-epileptic administration | Eighty-three of the 103 (42%) patients who had not received a second-line ASM before being admitted to the ICU received it within the first 24 h after admission, mainly within the first 6 h (Fig. Timing of second-line anti-seizure medicine (ASM) (panel | PMC9830759 | ||
Secondary outcomes | SUPER-REFRACTORY STATUS EPILEPTICUS | The ICU, hospital, and day 90 mortality rates were similar between the two groups as well as the proportion of patients developing refractory and super-refractory status epilepticus (Table | PMC9830759 | |
Adverse events | ADVERSE EVENTS | One or more adverse events of any grade of severity were declared by the investigators during hospital stay in 52 (44%) and 45 (36%) patients from the VPA and placebo groups, respectively ( | PMC9830759 | |
Discussion | epileptic, super-refractory | ADVERSE EVENTS, EPILEPTIC | In this multicentre, double-blind, randomised, controlled, and pragmatic trial, we found that the intravenous administration of VPA, in addition to first- and second-line ASMs, did not increase the proportion of patients discharged alive from hospital within the first 15 days. We also found that VPA did not increase th... | PMC9830759 |
Acknowledgements | Nawal Derridj-Ait-Younes, Yasmine Domingo-Saidji, Pierre Asfar, Raphaël Clere-Jehl | MARION, FRANCIS, HARLEY | We thank the members of the data and safety monitoring board (Nawal Derridj-Ait-Younes, Nabila Yasmine Domingo-Saidji, Abderraouf Hermez, Chanez Lazizi, Naima Imam-Sghiouar), Pr Philippe Aegerter for his support and advice in the early stages of the trial, and the trial participants who were willing to be randomly assi... | PMC9830759 |
Author contributions | HO | RECRUITMENT | TS was involved in conception of the work (PI), funding application, enrolment of participating centres, supervision of the data collection, participation in data analysis verification of the data and interpretation, writing of the manuscript, critical revision of the manuscript. HO and BC helped in conception of the w... | PMC9830759 |
Funding | MAY | Programme Hospitalier de Recherche Clinique 2010 of the French Ministry of Social Affairs and Health. VALSE ClinicalTrials.gov number, NCT01791868 registered May 2012. The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report, or in the decision ... | PMC9830759 | |
Availability of data and materials | MYASTHENIA GRAVIS | Data available: Yes. Data types: De-identified participant data. How to access data: De-identified patient data to reproduce results presented in the article when available: With publication Supporting Documents Document types: None. Who can access the data: Researchers whose proposed use of the data has been approved.... | PMC9830759 | |
Declarations | PMC9830759 | |||
Ethics approval and consent to participate | Ethics approval was granted by the French regulatory board ( | PMC9830759 | ||
Consent for publication | Not applicable. | PMC9830759 | ||
Competing interests | RS | RS received grants from the French Ministry of Health, the French Society of Intensive Care Medicine (SRLF), and the European Society of Intensive Care Medicine (ESICM). All other authors declare no competing interests. | PMC9830759 | |
References | PMC9830759 | |||
Background | hearing loss, Hearing loss | HEARING LOSS, AIDS, HEARING LOSS | Hearing loss is a growing health concern worldwide. Hearing aids (HAs) are the treatment of choice for hearing rehabilitation in most cases of mild-to-moderate hearing loss. However, many patients with hearing loss do not use HAs due to their high cost, stigma, and inaccessibility. Since smartphones are widely used, ma... | PMC10578122 |
Objective | We compared the audiological performance between an SHAA and a conventional HA in a prospective, multicenter randomized controlled trial. | PMC10578122 | ||
Methods | hearing loss | HEARING LOSS | Patients with mild-to-moderate hearing loss were prospectively enrolled from 2 tertiary hospitals and randomly assigned to either an SHAA (Petralex; IT4YOU Corp LLC) or a conventional HA (Siya 1 miniRITE; Oticon A/S). For the cross-over study design, participants used the alternate device and repeated the same 2-month ... | PMC10578122 |
Results | ADVERSE EVENTS | Overall, 63 participants were screened and 38 completed the study. In sound-field audiometry testing, the SHAA showed a 20- to 60-dB gain in the low-to-high frequencies of the hearing threshold level. The HA provided adequate gain in the middle-to-high frequencies (55, 65, and 75 dB in real-ear measurements), which is ... | PMC10578122 | |
Conclusions | hearing loss | HEARING LOSS | The HA showed better performance than the SHAA in word recognition and the HINT. However, the SHAA was significantly better than unaided hearing in terms of amplification. The SHAA may be a useful hearing assistance device for patients with mild-to-moderate hearing loss when listening to soft sounds in quiet conditions... | PMC10578122 |
Trial Registration | ClinicalTrials.gov NCT05644106; | PMC10578122 | ||
Introduction | hearing amplification, hearing impairment, REMs, hearing loss, Hearing loss | HEARING LOSS, HEARING IMPAIRMENT, AIDS, HEARING LOSS | Hearing loss is a common and growing global health issue. The World Health Organization (WHO) reported that approximately 2.5 billion people will experience hearing loss and 700 million will need hearing rehabilitation by 2050 [Hearing rehabilitation improves audiological performance, daily activity functioning, and qu... | PMC10578122 |
Methods | PMC10578122 | |||
Study Design | sensorineural, hearing amplification, tinnitus, Hearing impairment, hearing loss | SENSORINEURAL HEARING LOSS, ADVERSE EVENTS, TINNITUS, HEARING IMPAIRMENT, HEARING LOSS | A prospective randomized controlled trial was conducted at 2 tertiary hospitals in South Korea (the Department of Otolaryngology, Seoul National University Hospital and the Department of Otolaryngology, The Catholic University of Korea, Seoul St. Mary’s Hospital) from August 2020 to November 2022. The inclusion criteri... | PMC10578122 |
Ethical Considerations | This study was registered in the clinical trials registry in South Korea (Clinical Research Information Service; KCT0005458) [ | PMC10578122 | ||
Hearing Amplification Systems (HA and SHAA) | A pilot study that conducted behavioral evaluations of 3 SHAAs provided the evidence used to select an SHAA for this study [For the conventional HA, we used the Siya 1 miniRITE (Oticon A/S), coupled with two 85-dB receivers and single closed ear tips. The Siya 1 miniRITE is an essential-level HA, first introduced in 20... | PMC10578122 | ||
Sound-Field Audiometry and WRS Tests | WRS, hearing amplification | Sound-field audiometry (SFA) and WRS tests were performed using a calibrated Interacoustics AC40 (Interacoustics A/S). To determine the difference between the SHAA and the conventional HA, SFA was obtained at 0.25, 0.5, 1, 2, 3, 4, 6, and 8 kHz for both hearing amplification systems. Warble tone was used to avoid stand... | PMC10578122 | |
REM Test | REMs | This test measures actual HA gain by comparing the difference between the HA target value and the sound pressure measured using a microphone probe tip in the ear canal. We used Affinity 2.0 software (version 2.6.0; Serif Ltd) to conduct the REMs. To validate the HA performance, the REMs were performed using speech stim... | PMC10578122 | |
Hearing-in-Noise Test | The hearing-in-noise test (HINT) was developed to measure binaural speech recognition ability under quiet and noisy situations [ | PMC10578122 | ||
Questionnaires | For the measurement of subjective satisfaction, the APHAB and IOI-HA were used. The APHAB consists of 4 items: ease of communication, reverberation, background noise, and aversiveness of sounds. Each item has 6 questions, and higher scores indicate greater disability. This survey can be used to evaluate the performance... | PMC10578122 | ||
Statistical Analysis | A sample size of 26 would achieve 90% power to detect noninferiority with a 1-sided significance level of .025, and a cross-over design would have a margin of noninferiority of −10%, a true mean difference of 0, and an SD of the paired differences of 15, based on the test results from a previous study for understanding... | PMC10578122 | ||
Results | PMC10578122 | |||
SFA and WRS Results | WRS | The SHAA showed a slightly lower gain at all frequencies than the conventional HA, with statistical significance at 1000 Hz (Sound-field (warble-tone) audiometry thresholds in the HA and SHAA groups. Error bars indicate the SD. db HL: decibel of hearing level; HA: hearing aid; SHAA: smartphone-based hearing aid app. *I... | PMC10578122 | |
REM Results | In real-ear aided responses at 55 dB, the HA showed a larger gain at 1000, 2000, 3000, 4000, and 6000 Hz than the SHAA. The SHAA showed a larger gain at low frequencies (250 and 500 Hz) than the HA. Statistical significance was found at 500 Hz (Real-ear aided responses (REARs) of the hearing aid and SHAA groups measure... | PMC10578122 | ||
HINT Results | The mean SNRs (HINT performance) in the unaided, HA, and SHAA groups were 51.3 (SD 5.6), 47 (SD 3.4), and 56 (SD 6.4) dB, respectively, in a quiet situation (Hearing-in-noise test (HINT) in quiet, front noise, left noise, and right noise conditions for the unaided, hearing aid, and SHAA groups. Error bars indicate the ... | PMC10578122 | ||
Questionnaire Results | The mean score of the IOI-HA was 7 (SD 0), 23.4 (SD 4.0), and 16.3 (SD 4.9) in the unaided, HA, and SHAA groups, respectively (International Outcome Inventory for Hearing Aids (IOI-HA) items for the unaided, hearing aid, and SHAA groups. Error bars represent the SD. SHAA: smartphone-based hearing aid app. *In the ease ... | PMC10578122 | ||
Discussion | PMC10578122 | |||
Principal Findings | REMs, WRS | This study used a noninferiority study design to compare the audiological performance between an SHAA and a conventional HA. The SHAA did not show noninferiority to the HA in the WRS test, which was the primary measurement used in the original study. However, the SHAA showed feasibility in some users, especially in una... | PMC10578122 | |
Strengths and Limitations | To the best of our knowledge, this is the first prospective, multicenter randomized controlled trial comparing an SHAA and a conventional HA. Hearing performance was evaluated for comprehensive objective functional gain and for subjective satisfaction.In this study, we enrolled Android users who used their own smartpho... | PMC10578122 | ||
Conclusion | hearing loss | HEARING LOSS | In our study, the SHAA demonstrated a significant benefit when compared to an unaided situation. Our results indicate that the SHAA could be a useful assistive device for patients with mild-to-moderate hearing loss in quiet conditions. In addition, people with poor access to hearing amplification devices can more easil... | PMC10578122 |
Abbreviations | Abbreviated Profile of Hearing Aid Benefithearing aidhearing-in-noise testInternational Outcome Inventory for Hearing Aidspersonal sound amplification productpure-tone audiometryreal-ear measurementsound-field audiometrysmartphone-based hearing aid appsignal-to-noise ratiosound pressure levelWorld Health Organizationwo... | PMC10578122 | ||
References | CONSORT-eHEALTH checklist (V 1.6.1). | PMC10578122 | ||
1. Introduction | deaths, death, premature illness | PROLIFERATION, DISEASE, DISEASES | Young children are particularly vulnerable to harms from tobacco smoke exposure (TSE). This study aimed to compare TSE: (1) between children who live in smoking families and those who do not; and (2) among children who live in smoking households with varying smoking locations. The data came from two studies that were c... | PMC9965201 |
2. Materials and Methods | PMC9965201 | |||
2.1. Study Design, Samples and Procedures | The data came from two studies that were conducted in Israel at the same time between 2016 and 2018. The first study (Study 1) was a randomized controlled trial (RCT), “Project Zero Exposure,” which included 159 families with at least one parent who smoked cigarettes living in the household. The RCT assessed an interve... | PMC9965201 | ||
2.2. Eligibility Criteria | Inclusion criteria included: (1) at least one smoking parent living in the household who smoked at least 10 cigarettes per week (Study 1) or no parents who smoked in the household (Study 2); (2) having a child aged up to 8 years; (3) the parent(s) were willing to provide a hair sample for research purposes; and (4) chi... | PMC9965201 | ||
2.3. Ethics and Registration | National Institute of Health (NIH) Clinical Trials Registry: NCT02867241. Ethical approval was obtained from the Helsinki Committee of Asaf Harofe Hospital (0143-16 ASF), the Israel Ministry of Health (920090057), and the Tel Aviv University Ethics Committee. All parents provided written consent for their children to p... | PMC9965201 | ||
2.4. Measures | PMC9965201 | |||
2.4.1. Primary Outcome | The primary outcome for this analysis was child exposure to tobacco smoke, measured by hair nicotine. Child hair nicotine was chosen because it reflects long-term exposure (approximately 1 cm of hair growth/month) [We analyzed TSE in two ways. First, we assessed TSE as a binary variable indicating “exposed” (yes, above... | PMC9965201 | ||
2.4.2. Independent Measures | Study 1 vs. Study 2: The independent variable for the first analyses was whether the children were from smoking or non-smoking families. Study 1: The independent variable for the second assessment was the location of smoking. We asked parents to show us where they usually smoked, with the question “Where does smoking u... | PMC9965201 | ||
2.5. Statistical Analyses | Descriptive statistics were used to describe the study samples. | PMC9965201 | ||
2.5.1. Analyses, Smoking Families vs. Nonsmoking Families (Study 1 vs. Study 2) | We compared child TSE (above the LOD: yes vs. no) between non-smoking and smoking families using a chi-squared test. We used a linear model to compare child exposure between non-smoking and smoking families as measured by log-hair nicotine (LHN) while controlling for laboratory batch. Because of the small number of par... | PMC9965201 | ||
2.5.2. TSE by Location of Home Smoking and Other Explanatory Variables (Study 1) | CPD | REGRESSION | We first assessed TSE by location of home smoking using the LOD (dichotomous outcome: exposed vs. not exposed) using a chi-squared test. We also tested the bivariate relationship between above-LOD exposure and each of the following variables: number of parental smokers (both or one), child sex, parental nationality, ma... | PMC9965201 |
3. Results | PMC9965201 | |||
3.2. Characteristics of Smoking and Non-Smoking Families | Among non-smoking families, 3 of the 20 families reported that smoking sometimes took place on porches, but none of them reported smoking occurring in any other setting. | PMC9965201 | ||
3.3. Laboratory Batch Results | For the ten batches analyzed, LOD (ng/mg) ranged from 0.014–0.18 (mean LOD: 0.034, median LOD: 0.038). One batch had an LOD of 0.18 and another of 0.09. All other batches had LODs between 0.01 and 0.05. A histogram of hair mass can be found in | PMC9965201 | ||
3.4. Child TSE in Smoking vs. Nonsmoking Families | REGRESSION | Of the 141 children from smoking families with sufficient hair, 68.8% (In the linear regression of LHN, which included a term for laboratory batch, the group variable was borderline significant ( | PMC9965201 | |
3.6. The Association between Child TSE and Other Variables in Smoking Families | The only variable to reach statistical significance in the bivariable comparisons of the proportion of children exposed (Model 1) was paternal education ( | PMC9965201 | ||
4. Discussion | The purpose of this study was to compare tobacco smoke exposure [TSE] among children who live in smoking families versus those who do not, as well as among children who live in smoking households with varying smoking locations. We found that about a third of children of non-smoking parents were measurably exposed to to... | PMC9965201 | ||
Public Health Implications | In order to protect children from tobacco smoke exposure, consistent with current scientific evidence on smoke drift outdoors and indoors, smoking should not take place anyplace within at least 9 m [Parents will need substantial support to be able to make changes to better protect their children. We recommend intensive... | PMC9965201 | ||
5. Conclusions | Most children in participating smoking families were exposed to tobacco smoke regardless of whether the parents restricted smoking to a balcony, to designated indoor places such as “in the window,” or to the yard. To protect children from tobacco smoke in the Israeli setting, indoor home porches and outdoor porches tha... | PMC9965201 |
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