Tag: statistics

Cost Eff Resour Alloc. 2023 Nov 14;21(1):87. doi: 10.1186/s12962-023-00496-y.

ABSTRACT

BACKGROUND: Demonstrating safety and efficacy of new medical treatments requires clinical trials but clinical trials are costly and may not provide value proportionate to their costs. As most health systems have limited resources, it is therefore important to identify the trials with the highest value. Tools exist to assess elements of a clinical trial such as statistical validity but are not wholistic in their valuation of a clinical trial. This study aims to develop a measure of clinical trials value and provide an online tool for clinical trial prioritisation.

METHODS: A search of the academic and grey literature and stakeholder consultation was undertaken to identify a set of criteria to aid clinical trial valuation using multi-criteria decision analysis. Swing weighting and ranking exercises were used to calculate appropriate weights of each of the included criteria and to estimate the partial-value function for each underlying metric. The set of criteria and their respective weights were applied to the results of six different clinical trials to calculate their value.

RESULTS: Seven criteria were identified: ‘unmet need’, ‘size of target population’, ‘eligible participants can access the trial’, ‘patient outcomes’, ‘total trial cost’, ‘academic impact’ and ‘use of trial results’. The survey had 80 complete sets of responses (51% response rate). A trial designed to address an ‘Unmet Need’ was most commonly ranked as the most important with a weight of 24.4%, followed by trials demonstrating improved ‘Patient Outcomes’ with a weight of 21.2%. The value calculated for each trial allowed for their clear delineation and thus a final value ranking for each of the six trials.

CONCLUSION: We confirmed that the use of the decision tool for valuing clinical trials is feasible and that the results are face valid based on the evaluation of six trials. A proof-of-concept applying this tool to a larger set of trials with an external validation is currently underway.

PMID:37964269 | DOI:10.1186/s12962-023-00496-y

Pediatr Rheumatol Online J. 2023 Nov 14;21(1):138. doi: 10.1186/s12969-023-00923-7.

ABSTRACT

OBJECTIVE: To explore the different menstrual and pubertal abnormalities in adolescent females with systemic autoimmune rheumatic diseases (ARD).

METHODS: The study included adolescent girls aged 13-18 years with juvenile idiopathic arthritis (JIA), juvenile systemic lupus erythematosus (JSLE), and juvenile dermatomyositis (JDM) classified according to their international classification criteria. Data were collected from our patients’ files and interpreted with respect to the demographic, clinical, disease assessment parameters, medications used, and the hormonal profile. The aspects of puberty and menstruation were assessed by a gynaecologist with ultrasound evaluation as well. The girls were classified according to their menstrual pattern into those with regular cycles versus abnormal ones. The subgroups were compared and significant variables entered into a logistic regression model to detect the independent predictors.

RESULTS: Twenty-one girls with JSLE were included, besides 23 JIA and 8 JDM cases. Ten patients with JSLE (47.6%) had menstrual abnormalities, whereas only four JIA (17.4%) and 1 JDM girls had these alterations without significant difference between the three groups. The median of the SLICC/ACR damage index was statistically higher in JSLE with abnormal menstrual cycles, similarly were the cumulative steroid dose and puberty onset. No difference was observed between JIA or JDM subgroups concerning the disease parameters, hormonal profile, ultrasound assessment or the treatment lines. The most significant predictor for menstrual abnormalities in JSLE was the SLICC/ACR damage index.

CONCLUSION: Menstrual abnormalities is a common disturbance among adolescent girls with ARDs. The SLICC/ACR damage index is the main determinant for menstrual abnormalities rather than the cumulative steroid use or disease duration in JSLE.

PMID:37964263 | DOI:10.1186/s12969-023-00923-7

BMC Public Health. 2023 Nov 14;23(1):2247. doi: 10.1186/s12889-023-17189-z.

ABSTRACT

BACKGROUND: Absenteeism is consistently higher in public than in private organizations, as is the use of part-time employment. The aim of this study is to identify whether there is a relationship between part-time work and sickness absence at the organizational level.

METHODS: The data is a six-year panel for the full population of Norwegian municipalities (N = 422), linking objective register data on both part-time employment and sickness absence. Using OLS regression with fixed effects for municipality and time, we estimate the statistical effects of the municipalities’ use of part-time work on sickness absence.

RESULTS: The bivariate correlation between percentage position at the municipal level and percentage sickness absence is positive and significant (Pearson’s r = .25, sig LE 0.01). When controlling for fixed effects for municipality and time, as well as municipality economy, municipality size, ratio of female employees in the municipality and characteristics of the general population, the multivariate regression coefficient is still positive but insignificant (coefficient = 1.56, robust standard error = 1.31).

CONCLUSIONS: The main findings are that the organizations’ use of part-time work is unrelated to sickness absence indicating that organizations with extensive use of part-time work do not experience higher levels of absenteeism than those having less extensive use of part-time employees.

PMID:37964256 | DOI:10.1186/s12889-023-17189-z

BMC Public Health. 2023 Nov 14;23(1):2246. doi: 10.1186/s12889-023-17002-x.

ABSTRACT

BACKGROUND: Poor body image is prevalent among adolescents and associated with several negative outcomes for their physical and psychological health. There is a pressing need to address this growing public health concern, yet there are few evidence-informed universal programmes for older adolescents that address contemporary body image concerns (i.e., social media). BodyKind is a four lesson, school-based, teacher led, universal body image programme that incorporates empirically supported principles of cognitive dissonance, self-compassion, compassion for others and social activism, to support positive body image development. Building on previous pilot trials in the USA, this paper outlines the protocol for a cluster randomised control trial (cRCT) and implementation evaluation of the BodyKind programme which was culturally adapted for the Irish cultural context.

METHODS: We aim to recruit 600 students aged 15-17 years in Transition Year (4^th year) across 26 second-level schools in Ireland. Using minimisation, schools will be randomly assigned to receive BodyKind (intervention condition, n=300) or classes as usual (waitlist control, n=300). Teachers in intervention groups will receive training and deliver the programme to students over four weeks, at a rate of one lesson per week. Primary outcomes of body appreciation, body dissatisfaction and psychological wellbeing and secondary outcomes of self-compassion, compassion for others, body ideal internalisation, social justice motives and appearance-based social media use will be assessed at pre-, post- and 2 month follow up. Mediation and moderation analyses will be conducted to identify how and for whom the intervention works best. An implementation evaluation will assess the quality of programme implementation across schools and how this may influence intervention outcomes. Waitlist control schools will receive the programme after the 2-month follow up.

CONCLUSION: This study will be the first to implement a cRCT and an implementation evaluation to assess the impact of this multicomponent school-based body image programme designed to support healthy body image development. If shown to be effective, BodyKind will have the potential to improve adolescent body image and wellbeing and inform efforts to implement sustainable and scalable programmes in schools.

TRIAL REGISTRATION: The trial was retrospectively registered on 10/10/2023 on ClinicalTrials.gov NCT06076993 .

PMID:37964252 | DOI:10.1186/s12889-023-17002-x

BMC Nurs. 2023 Nov 14;22(1):427. doi: 10.1186/s12912-023-01583-4.

ABSTRACT

BACKGROUND: South Korea has already become a multicultural society due to immigration, marriage, and employment of foreigners, and the use of medical institutions by foreigners is increasing. In order to establish a therapeutic rapport relationship with foreigners, it is necessary to study multicultural acceptance. This study aimed to examine and identify the factors influencing the degree of multicultural acceptance of Korean nursing students.

METHODS: This study used a cross-sectional descriptive design. Study participants included 147 nursing students at University in Seoul or Gyeonggi-do, South Korea. Data included demographics, multicultural acceptance, cultural empathy, and multicultural attitude. Data were collected from March to June 2021. Data was analyzed using linear regression model in SPSS PC + version 23.0 statistical software program.

RESULTS: The adjusted R-squared representing the explanatory power of the model was 72.5%. The strongest predictor was cultural empathy (β = 0.55, P < 0.001), followed by multicultural attitude (β = 0.26, P = 0.001), residential area where they lived for the past 5 years (β = 0.19, P = 0.001), accessibility to multicultural internet and media (β = 0.17, P = 0.003), whether they have foreign friends (β = 0.16, P = 0.003), and multicultural education experience (β = 0.02, P = 0.002).

CONCLUSION: This study suggests that to improve the degree of multicultural acceptance of Korean nursing students, their cultural empathy and multicultural attitude should be strengthened. Nurses need to pay attention the influencing factors to improve the multicultural acceptance of Korean nursing students.

PMID:37964251 | DOI:10.1186/s12912-023-01583-4

BMC Womens Health. 2023 Nov 14;23(1):602. doi: 10.1186/s12905-023-02773-7.

ABSTRACT

BACKGROUND: The aim of this study was to compare the efficacy of the combination of clomiphene citrate (CC) and letrozole to that of CC alone in inducing ovulation in infertile women with ovulatory dysfunction.

METHODS: A randomized controlled trial was conducted at a single academic medical center between November 2020 and December 2021. Anovulatory infertility females, aged 18 to 40, were evenly distributed by a computer-generated block of four into two treatment groups. A “combination group” received a daily dose of CC (50 mg) and letrozole (2.5 mg), while a “CC-alone group” received a daily dose of CC alone (50 mg). The study medications were administered on days 3 through 7 of menstrual cycle. The primary outcome was the ovulation rate, defined by serum progesterone levels exceeding 3 ng/mL at the mid-luteal phase. The secondary outcomes were ovulation induction cycle characteristics, endometrial thickness, conception rate, and adverse events.

RESULTS: One hundred women (50 per group) were enrolled in the study. The mean age was not significantly different in both groups: 31.8 years in the combination group and 32.4 years in the CC-alone groups (P = 0.54). The prevalence of polycystic ovary syndrome in the combination and CC-alone groups was 48% and 44%, respectively (P = 0.841). According to intention-to-treat analysis, the ovulation rates were 78% and 70% in the combination and CC-alone groups, respectively (P > 0.05). There was no significant difference in the mean endometrial thickness or the number of dominant follicles of the groups. No serious adverse events were observed in either group.

CONCLUSIONS: Our study found no significant difference between the combination of CC and letrozole and CC alone in inducing ovulation in infertile women with ovulatory dysfunction in one cycle. The small number of live births precluded any meaningful statistical analysis. Further studies are needed to validate and extend our findings beyond the scope of the current study.

TRIAL REGISTRATION: The study was registered at https://www.thaiclinicaltrials.org with the following number: TCTR20201108004 and was approved on 08/11/2020.

PMID:37964246 | DOI:10.1186/s12905-023-02773-7

J Occup Med Toxicol. 2023 Nov 14;18(1):25. doi: 10.1186/s12995-023-00394-2.

ABSTRACT

OBJECTIVES: This study evaluates the six-month cost-effectiveness and cost-benefits of motivational interviewing (MI) or a stratified vocational advice intervention (SVAI) added to usual case management (UC) for workers on sick leave due to musculoskeletal disorders.

METHODS: This study was conducted alongside a three-arm RCT including 514 employed workers on sick leave for at least 50% for ≥ 7 weeks. All participants received UC. The UC + MI group received two MI sessions, and the UC + SVAI group received 1-4 SVAI sessions. Sickness absence days, quality-adjusted life-years (QALYs), and societal costs were measured between baseline and six months.

RESULTS: Adding MI to UC, resulted in incremental cost-reduction of -2580EUR (95%CI -5687;612), and a reduction in QALYs of -0.001 (95%CI -0.02;0.01). Secondly, adding MI to UC resulted in an incremental cost-reduction of -538EUR (95%CI -1358;352), and reduction of 5.08 (95%CI -3.3;13.5) sickness-absence days. Financial return estimates were positive, but not statistically significant. Adding SVAI to UC, resulted in an incremental cost-reduction of -2899 EUR (95% CI -5840;18), and a reduction in QALYs of 0.002 (95% CI -0.02;0.01). Secondly, adding SVAI to UC resulted in an statistically significant incremental cost-reduction of -695 EUR (95% CI -1459;-3), and a reduction of 7.9 (95% CI -0.04;15.9) sickness absence days. Financial return estimates were positive and statistically significant. The probabilities of cost-effectiveness for QALYs were high for adding MI or SVAI (ceiling ratio 0.90).

CONCLUSIONS: In comparison to UC only, adding MI to UC tends to be cost-effective. Adding SVAI to UC is cost-effective for workers on sick leave due to musculoskeletal disorders.

TRIAL REGISTRATION: ClinicalTrials.gov (identifier: NCT03871712).

PMID:37964240 | DOI:10.1186/s12995-023-00394-2

BMC Womens Health. 2023 Nov 14;23(1):600. doi: 10.1186/s12905-023-02737-x.

ABSTRACT

BACKGROUND: Epidemiological studies have revealed multiple risk factors for metabolic syndrome. However, there are no consistent findings on the association between famine exposure, age at menarche, and the prevalence of metabolic syndrome. This cross-sectional study aimed to reveal the individual and combined effects of famine exposure and age at menarche on the prevalence of metabolic syndrome among elderly women.

METHODS: Four thousand seven hundred seventy participants between 60 and 93 years of age were selected from the China Health and Retirement Longitudinal Study. Statistical differences between the baseline characteristics of famine exposure, age at menarche, and metabolic syndrome were evaluated using the t-test, F-test, and Chi-square test. Three multivariable-adjusted logistic regression models were used to test the association between famine exposure, age of menarche, and the odds ratio of metabolic syndrome.

RESULTS: Two thousand one hundred ninety-eight (46.08%) participants had metabolic syndrome, while 2572 (53.92%) participants did not. Furthermore, 3068 (64.32%) women reported onset of menarche under 15 years of age, while 1702 (35.68%) women reported onset of menarche above 16 years of age. Regarding the separate association of famine exposure and age of menarche with metabolic syndrome, in model three, the adolescence/adulthood famine exposure group vs. no famine exposure group odds ratio was 2.45 (95% CI 2.02, 2.97), and the older than 16 years vs. younger than 15 years group odds ratio was 1.23 (95% CI 1.09, 1.39), which was the highest odds ratio among the three models. Regarding the combined association of famine exposure and age of menarche with metabolic syndrome, in model three, among the age of menarche ≤ 15 years group, the adolescence/adulthood famine exposure vs. no famine exposure group odds ratio was 2.45 (95% CI: 1.91, 3.14); among the menarche age ≥ 16 years group, the adolescence/adulthood famine exposure stages vs. exposed group odds ratio was 3.27 (95% CI: 2.44, 4.38), which was the highest odds ratio among the three models.

CONCLUSION: These findings suggested that famine exposure and age at menarche, either separately or in combination, were positively associated with the prevalence of metabolic syndrome among older women.

PMID:37964223 | DOI:10.1186/s12905-023-02737-x

BMC Plant Biol. 2023 Nov 15;23(1):562. doi: 10.1186/s12870-023-04583-3.

ABSTRACT

BACKGROUND: Eucommia ulmoides leaves have high medicinal and economic value as a dual-purpose substance for medicine and food. Employing leaves from 13 natural populations of Eucommia ulmoides as research objects, this study reveals the variation patterns of intra-specific and inter-specific trait variation and explores the response of leaf characteristics to geographical and climatic changes, aiming to provide a scientific basis for the efficient utilization of leaf resources and the breeding of superior varieties.

RESULTS: Descriptive statistical analysis and nested analysis of variance showed significant differences in 11 leaf traits of Eucommia ulmoides inter-populations and intra-populations, with an average coefficient of variation of 17.45%. The coefficient of variation for average leaf phenotypic traits is 20.77%, and the leaf phenotypic variation is mainly from the variation intra-populations. Principal component analysis reveals that the cumulative contribution rate of the top three principal components which mainly contributed to the phenotypic variation of Eucommia ulmoides leaves reached 74.98%, which could be sorted into size traits (34.57%), color traits (25.82%) and shape traits (14.58%). In addition, correlation analysis expresses there is a specific co-variation pattern among leaf traits, with a strong connection between shape, size, and color traits. Geographic and climatic distances are significantly correlated, and mantel test and correlation analysis indicate that leaf traits of Eucommia ulmoides are mainly influenced by altitude. With the increase of altitude, the leaves become smaller. Partial correlation analysis shows that after controlling climate factors, the correlation between some characters and geographical factors disappears significantly. Temperature and precipitation have a great influence on the variation of leaf phenotypic traits, and the larger the leaves are in areas with high temperature and heavy rainfall.

CONCLUSIONS: These findings contribute to a further understanding of the leaf morphological characteristics of Eucommia ulmoides and the extent to which the environment influences leaf trait variation. They can provide a scientific basis for the protection and application of Eucommia ulmoides leaf resources in the future.

PMID:37964219 | DOI:10.1186/s12870-023-04583-3

BMC Med Imaging. 2023 Nov 14;23(1):185. doi: 10.1186/s12880-023-01136-w.

ABSTRACT

BACKGROUND: ¹H magnetic resonance spectroscopy (¹H-MRS) can be used to study neurological disorders because it can be utilized to examine the concentrations of related metabolites. However, the diagnostic utility of different field strengths for temporal lobe epilepsy (TLE) remains unclear. The purpose of this study is to make quantitative comparisons of metabolites of TLE at 1.5T and 3.0T and evaluate their efficacy.

METHODS: Our retrospective collections included the single-voxel ¹H-MRS of 23 TLE patients and 17 healthy control volunteers (HCs) with a 1.5T scanner, as well as 29 TLE patients and 17 HCs with a 3.0T scanner. Particularly, HCs were involved both the scans with 1.5T and 3.0T scanners, respectively. The metabolites, including the N-acetylaspartate (NAA), creatine (Cr), and choline (Cho), were measured in the left or right temporal pole of brain. To analyze the ratio of brain metabolites, including NAA/Cr, NAA/Cho, NAA/(Cho + Cr) and Cho/Cr, four controlled experiments were designed to evaluate the diagnostic utility of TLE on 1.5T and 3.0T MRS, included: (1) 1.5T TLE group vs. 1.5T HCs by the Mann-Whitney U Test, (2) 3.0T TLE group vs. 3.0T HCs by the Mann-Whitney U Test, (3) the power analysis for the 1.5T and 3.0T scanner, and (4) 3.0T HCs vs. 1.5T HCs by Paired T-Test.

RESULTS: Three metabolite ratios (NAA/Cr, NAA/Cho, and NAA/(Cho + Cr) showed the same statistical difference (p < 0.05) in distinguishing the TLE from HCs in the bilateral temporal poles when using 1.5T or 3.0T scanners. Similarly, the power analysis demonstrated that four metabolite ratios (NAA/Cr, NAA/Cho, NAA/(Cho + Cr), Cho/Cr) had similar distinction abilities between 1.5T and 3.0T scanner, denoting both 1.5T and 3.0T scanners were provided with similar sensitivities and reproducibilities for metabolites detection. Moreover, the metabolite ratios of the same healthy volunteers were not statistically different between 1.5T and 3.0T scanners, except for NAA/Cho (p < 0.05).

CONCLUSIONS: 1.5T and 3.0T scanners may have comparable diagnostic potential when ¹H-MRS was used to diagnose patients with TLE.

PMID:37964218 | DOI:10.1186/s12880-023-01136-w