Category: Statistics

Health Soc Care Deliv Res. 2023 Nov;11(24):1-112. doi: 10.3310/HTPM3841.

ABSTRACT

BACKGROUND: The information provided to potential trial participants plays a crucial role in their decision-making. Printed participant information sheets for trials have received recurrent criticism as being too long and technical, unappealing and hard to navigate. An alternative is to provide information through multimedia (text, animations, video, audio, diagrams and photos). However, there is limited evidence on the effects of multimedia participant information on research recruitment rates, particularly in children and young people.

OBJECTIVES: The study objectives were as follows: 1. to develop template multimedia information resources through participatory design, for use when recruiting children and young people to trials 2. to evaluate the multimedia information resources in a series of Studies Within A Trial, to test their effects on recruitment and retention rates, and participant decision-making, by comparing the provision of multimedia information resources instead of printed participant information sheets, and comparing the provision of multimedia information resources in addition to printed participant information sheets.

DESIGN: Two-phase study: 1. multimedia information resources development including qualitative study; user testing study; readability metrics; enhanced patient and public involvement 2. multimedia information resources’ evaluation comprising Studies Within A Trial undertaken within host trials recruiting children and young people.

SETTING: United Kingdom trials involving patients aged under 18.

PARTICIPANTS: Development phase: n = 120 (children and young people, parents, clinicians, trial personnel). Evaluation phase: n = 1906 (children and young people being asked to take part in trials).

INTERVENTIONS: Multimedia information resources (comprising text, audio, ‘talking heads’ video, trial-specific and trial-generic animations). Printed participant information sheets.

MAIN OUTCOME MEASURES: Primary outcome: trial recruitment rate comparing multimedia information resource-only with printed participant information sheet-only provision. Secondary outcomes: trial recruitment rate comparing combined multimedia information resource and printed participant information sheet with printed participant information sheet-only provision; trial retention rate; quality of participant decision-making. Results for each trial were calculated and combined in a two-stage random-effects meta-analysis.

RESULTS: Phase 1 generated two multimedia information resource templates: (1) for children aged 6-11 years; (2) for children aged 12-18 years and parents. In the Phase 2 Studies Within A Trial the multimedia information resources improved trial recruitment, when compared to printed information alone [odds ratio (OR) = 1.54; 95% confidence interval (CI) 1.05 to 2.28; p = 0.03; I² = 0%]. When printed participant information sheet-only provision was compared to combined multimedia information resource and printed participant information sheet provision, there was no effect on trial recruitment (OR = 0.89; 95% CI 0.53 to 1.50; I² = 0%). There were no differences between multimedia information resource and printed participant information sheet on trial retention or participant decision-making quality. In a study within a hypothetical trial setting, multimedia information resource-only provision produced higher ratings of ‘information was easy to understand’ (Z = 3.03; p = 0.003) and ‘I had confidence in decision-making’ (Z = 2.00; p = 0.044) than printed participant information sheet-only provision.

LIMITATIONS: It was not possible to include data from three Studies Within A Trial in the meta-analysis due to limited sample size, and questionnaire return rates were low, which reduced the strength of the findings.

CONCLUSIONS: Use of multimedia information increased the rate of recruitment to trials involving children and young people compared to standard patient information sheets.

FUTURE WORK: There should be further evaluation of the effects of multimedia information on recruitment to trials involving children and young people. It would be valuable to assess any impacts of multimedia information resources on communication between trial recruiters, children and young people, and parents.

STUDY REGISTRATION: This trial is registered as TRECA ISRCTN 73136092 and Northern Ireland Hub for Trials Methodology Research SWAT Repository (SWAT 97).

FUNDING: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 14/21/21) and is published in full in Health and Social Care Delivery Research; Vol. 11, No. 24. See the NIHR Funding and Awards website for further award information.

PMID:38140894 | DOI:10.3310/HTPM3841

Inquiry. 2023 Jan-Dec;60:469580231218421. doi: 10.1177/00469580231218421.

ABSTRACT

In Ethiopia, the WHO strategies to stop coronavirus transmission were implemented rapidly. As a result, there was a rapid change in hygiene behavior, which are basic for preventing COVID-19 and other contagious diseases. This research was designed to examine the sustainability of the COVID-19 imposed hygiene behaviors for future challenges. The study was conducted in 2 major nexus areas in Addis Ababa. The data were collected using a questionnaire and spot-check from 622 respondents selected by systematic random sampling. The questionnaire was given at every 15th interval in several spots of the site. Observational hygiene-check was done through observing key personal hygiene conditions. Proportion, χ² test, and Poisson’s regression were applied for the analysis. The χ²-test analyses showed that the hand washing frequency before, during, and post-COVID-19 was statistically significant (P < .005). Findings from the spot-check also show that the hands of 76.8%, the nails of 68.7%, and the hairs of 70.7% of the respondents were clean. The major driving factors for the rapid changes in hygiene behavior were the awareness developed (95%), the fear and panic (90%), and increased access to water and soap (63%). Nevertheless, the major reasons for failing to continue the COVID-19-imposed good hygiene practice in the post-COVID-19 times include the decline in infection and death rates (26%) and the decline in facility access (20%). Hand washing frequency significantly changed during the COVID-19 pandemic indicating that the practice as part of the preventive strategy was successful. However, as this was mainly due to the fear and panic in the community, the COVID-19 imposed hand washing practice did not bring real and sustainable behavioral changes. This indicates that for long-lasting changes in hygiene behavior, continuous and better approach need to be introduced.

PMID:38140893 | DOI:10.1177/00469580231218421

Am J Health Promot. 2023 Dec 23:8901171231224101. doi: 10.1177/08901171231224101. Online ahead of print.

ABSTRACT

OBJECTIVE: The concept of self-efficacy is a determining factor in many behaviours related to health promotion and health education. Several pilot studies have been conducted in different parts of the world on different populations regarding the impact of training based on the Pender Health Promotion Model on self-efficacy, yielding conflicting results. Therefore, the present systematic review and meta-analysis were conducted with the aim of evaluating and summarizing the results of studies on the impact of training based on the Pender Health Promotion Model on self-efficacy.

DATA SOURCE: MagIran, SID, PubMed, Embase, Web of Science (WoS), Scopus and Google Scholar.

STUDY INCLUSION AND EXCLUSION CRITERIA: Original scientific research articles; Interventional studies; Studies investigating the effects of education based on the Pender Health Promotion Model on self-efficacy; Studies irrelevant to the objective; Cross-sectional studies; case reports; and papers presented in conferences; letters to the editor; systematic and meta-analysis studies.

DATA EXTRACTION: Two independent reviewers extracted data and assessed the quality of the 18 included studies using a pre-prepared checklist for the systematic review and meta-analysis process.

DATA SYNTHESIS: We conducted meta-analyses and reported the characteristics, outcomes, and risk of bias of studies.

METHODS: The present study was conducted according to PRISMA guidelines until December 2022. The quality assessment of the included articles for meta-analysis was performed using the JBI checklist. Heterogeneity of the studies was calculated using the I² statistics, and Egger’s regression intercept was used to assess publication bias.

RESULTS: In the initial search, 13,943 studies were found, and after excluding studies irrelevant to the research objective, a total of 18 articles were included in the meta-analysis. These articles represented a sample size of 1015 individuals in the intervention group and 999 individuals in the control group. The combined results of the studies showed a significant increase in self-efficacy in the intervention group when compared to the control group (1.788 ± .267; CI: 95%, P < .001). With an increase in the year of study and the quality assessment score of the articles, the effect of the intervention decreased (P < .001).

CONCLUSION: The results of this study indicated that training based on the Pender Health Promotion Model significantly increased self-efficacy. Therefore, it seems that training based on this model can have positive effects on individuals’ self-efficacy.

PMID:38140882 | DOI:10.1177/08901171231224101

Mult Scler. 2023 Dec 23:13524585231216004. doi: 10.1177/13524585231216004. Online ahead of print.

ABSTRACT

BACKGROUND: As of September 2022, there was no globally recommended set of core data elements for use in multiple sclerosis (MS) healthcare and research. As a result, data harmonisation across observational data sources and scientific collaboration is limited.

OBJECTIVES: To define and agree upon a core dataset for real-world data (RWD) in MS from observational registries and cohorts.

METHODS: A three-phase process approach was conducted combining a landscaping exercise with dedicated discussions within a global multi-stakeholder task force consisting of 20 experts in the field of MS and its RWD to define the Core Dataset.

RESULTS: A core dataset for MS consisting of 44 variables in eight categories was translated into a data dictionary that has been published and disseminated for emerging and existing registries and cohorts to use. Categories include variables on demographics and comorbidities (patient-specific data), disease history, disease status, relapses, magnetic resonance imaging (MRI) and treatment data (disease-specific data).

CONCLUSION: The MS Data Alliance Core Dataset guides emerging registries in their dataset definitions and speeds up and supports harmonisation across registries and initiatives. The straight-forward, time-efficient process using a dedicated global multi-stakeholder task force has proven to be effective to define a concise core dataset.

PMID:38140852 | DOI:10.1177/13524585231216004

Acta Obstet Gynecol Scand. 2023 Dec 23. doi: 10.1111/aogs.14757. Online ahead of print.

ABSTRACT

INTRODUCTION: Obstetric care is a highly active area in the development and application of prognostic prediction models. The development and validation of these models often require the utilization of advanced statistical techniques. However, failure to adhere to rigorous methodological standards could greatly undermine the reliability and trustworthiness of the resultant models. Consequently, the aim of our study was to examine the current statistical practices employed in obstetric care and offer recommendations to enhance the utilization of statistical methods in the development of prognostic prediction models.

MATERIAL AND METHODS: We conducted a cross-sectional survey using a sample of studies developing or validating prognostic prediction models for obstetric care published in a 10-year span (2011-2020). A structured questionnaire was developed to investigate the statistical issues in five domains, including model derivation (predictor selection and algorithm development), model validation (internal and external), model performance, model presentation, and risk threshold setting. On the ground of survey results and existing guidelines, a list of recommendations for statistical methods in prognostic models was developed.

RESULTS: A total of 112 eligible studies were included, with 107 reporting model development and five exclusively reporting external validation. During model development, 58.9% of the studies did not include any form of validation. Of these, 46.4% used stepwise regression in a crude manner for predictor selection, while two-thirds made decisions on retaining or dropping candidate predictors solely based on p-values. Additionally, 26.2% transformed continuous predictors into categorical variables, and 80.4% did not consider nonlinear relationships between predictors and outcomes. Surprisingly, 94.4% of the studies did not examine the correlation between predictors. Moreover, 47.1% of the studies did not compare population characteristics between the development and external validation datasets, and only one-fifth evaluated both discrimination and calibration. Furthermore, 53.6% of the studies did not clearly present the model, and less than half established a risk threshold to define risk categories. In light of these findings, 10 recommendations were formulated to promote the appropriate use of statistical methods.

CONCLUSIONS: The use of statistical methods is not yet optimal. Ten recommendations were offered to assist the statistical methods of prognostic prediction models in obstetric care.

PMID:38140844 | DOI:10.1111/aogs.14757

Acta Paediatr. 2023 Dec 23. doi: 10.1111/apa.17075. Online ahead of print.

ABSTRACT

AIM: We examined the outcomes of using inhaled nitric oxide (iNO) to treat very preterm born (VPT) infants across Europe.

METHODS: This was a sub-study of the Screening to Improve Health in Very Preterm Infants in Europe research. It focused on all infants born between 22 + 0 and 31 + 6 weeks/days of gestation from 2011 to 2012, in 19 regions in 11 European countries. We studied 7268 infants admitted to neonatal care and 5 years later, we followed up the outcomes of 103 who had received iNO treatment. They were compared with 3502 propensity score-matched controls of the same age who did not receive treatment.

RESULTS: All countries used iNO and 292/7268 (4.0%) infants received this treatment, ranging from 1.2% in the UK to 10.5% in France. There were also large regional variations within some countries. Infants treated with iNO faced higher in-hospital mortality than matched controls (odds ratio 2.03, 95% confidence interval 1.33-3.09). The 5-year follow-up analysis of 103 survivors showed no increased risk of neurodevelopmental impairment after iNO treatment.

CONCLUSION: iNO was used for VPT patients in all 11 countries. In-hospital mortality was increased in infants treated with iNO, but long-term neurodevelopmental outcomes were not affected in 103 5-year-old survivors.

PMID:38140833 | DOI:10.1111/apa.17075

Integr Cancer Ther. 2023 Jan-Dec;22:15347354231220608. doi: 10.1177/15347354231220608.

ABSTRACT

OBJECTIVE: evaluate the efficacy of Zingiber Officinale in the management of nausea and vomiting induced by treatment with cisplatin associated with radiotherapy in patients with uterine cervical neoplasms.

METHODS: a triple-blind, randomized, placebo-controlled trial. Interventions: Comparing the effects of ginger with institutional antiemetic therapy (ondansetron with dexamethasone). Patients with cervical cancer who started treatment with cisplatin with an indication of 40 mg/m² associated with radiotherapy, aged over 18 years, and with the ability to tolerate swallowing a capsule were recruited and equally allocated (1:1:1) into 3 groups of 16 patients each (the ginger capsules 250 mg group, ginger capsules 500 mg group, and placebo group). Nausea and vomiting were measured on baseline, 7 days after the first dose of medication and every seven consecutive days during a treatment break.

RESULTS: The 250 mg ginger group had an 8.0% greater chance of experiencing nausea within 24 h after the chemotherapy infusion than the placebo group, although there is no statistical significance (P = .92986). The 500 mg ginger group showed a 63.9% reduction in nausea under the same conditions (P = .40460). No change was detected in the occurrence of nausea episodes during the 6 weeks (P = .8664) or between the groups (P = .2817). No change was detected in acute or late vomiting during the 6 weeks (P = .3510) or between the groups (P = .8500 and P = .5389, respectively).

CONCLUSION: Ginger supplementation does not reduce the intensity of acute and late nausea and vomiting. REBEC (RBR-47yx6p9).

PMID:38140826 | DOI:10.1177/15347354231220608

Phys Rev Lett. 2023 Dec 8;131(23):233601. doi: 10.1103/PhysRevLett.131.233601.

ABSTRACT

The Hong-Ou-Mandel (HOM) effect is crucial for quantum information processing, and its visibility determines the system’s quantum-classical characteristics. In an experimental and theoretical study of the spectral HOM effect between a thermal field and a heralded single-photon state, we demonstrate that the HOM visibility varies dependent on the relative photon statistics of the interacting fields. Our findings reveal that multiphoton components in a heralded state get engaged in quantum interference with a thermal field, resulting in improved visibilities at certain mean photon numbers. We derive a theoretical relationship for the HOM visibility as a function of the mean photon number of the thermal field and the thermal part of the heralded state. We show that the nonclassicality degree of a heralded state is reflected in its HOM visibility with a thermal field; our results establish a lower bound of 41.42% for the peak visibility, indicating the minimum assignable degree of nonclassicality to the heralded state. This research enhances our understanding of the HOM effect and its application to high-speed remote secret key sharing, addressing security concerns due to multiphoton contamination in heralded states.

PMID:38134802 | DOI:10.1103/PhysRevLett.131.233601

Phys Rev Lett. 2023 Dec 8;131(23):231801. doi: 10.1103/PhysRevLett.131.231801.

ABSTRACT

Extending the Higgs sector of the standard model (SM) by just one additional Higgs doublet field leads to the two-Higgs-doublet model (2HDM). In the type-I Z_{2}-symmetric limit of the 2HDM, all the five new physical Higgs states can be fairly light, O(100) GeV or less, without being in conflict with current data from the direct Higgs boson searches and the B-physics measurements. In this Letter, we establish that the new neutral as well as the charged Higgs bosons in this model can all be simultaneously observable in the multi-b final state. The statistical significance of the signature for each of these Higgs states, resulting from the electroweak (EW) production of their pairs, can exceed 5σ at the 13 TeV high-luminosity Large Hadron collider (HL-LHC). Since the parameter space configurations where this is achievable are precluded in the other, more extensively pursued, 2HDM types, an experimental validation of our findings would be a clear indication that the true underlying Higgs sector in nature is the type-I 2HDM.

PMID:38134801 | DOI:10.1103/PhysRevLett.131.231801

Phys Rev Lett. 2023 Dec 8;131(23):237101. doi: 10.1103/PhysRevLett.131.237101.

ABSTRACT

We derive general bounds on the probability that the empirical first-passage time τ[over ¯]_{n}≡∑_{i=1}^{n}τ_{i}/n of a reversible ergodic Markov process inferred from a sample of n independent realizations deviates from the true mean first-passage time by more than any given amount in either direction. We construct nonasymptotic confidence intervals that hold in the elusive small-sample regime and thus fill the gap between asymptotic methods and the Bayesian approach that is known to be sensitive to prior belief and tends to underestimate uncertainty in the small-sample setting. We prove sharp bounds on extreme first-passage times that control uncertainty even in cases where the mean alone does not sufficiently characterize the statistics. Our concentration-of-measure-based results allow for model-free error control and reliable error estimation in kinetic inference, and are thus important for the analysis of experimental and simulation data in the presence of limited sampling.

PMID:38134782 | DOI:10.1103/PhysRevLett.131.237101