Tag: statistics

Pilot Feasibility Stud. 2022 Aug 26;8(1):191. doi: 10.1186/s40814-022-01154-5.

ABSTRACT

BACKGROUND: Local politicians can serve as enablers or barriers for health and social organizations to implement evidence, impacting the context of health and social service organizations. Increasing local politicians’ knowledge about, and support for, evidence-based practice (EBP) could be a way to strengthen the conditions in social service organizations for EBP. The aim of the study was to describe the development and assess the perceived feasibility, acceptability, and appropriateness of an intervention to enable local political committees to support the implementation of EBP. Furthermore, the achievement of the learning outcomes was examined.

METHODS: Workshops and interviews were used to co-create the intervention with social service representatives (n = 8) and local politicians (n = 6). A single-arm, non-blinded feasibility study was conducted in a social welfare committee with local politicians (n = 14) and representatives from social services (n = 4). Interviews and pre-post questionnaires were used to assess the intervention’s feasibility, acceptability, appropriateness, and learning outcomes. Progression criteria was set to > 80% of respondents judging the intervention to be feasible, acceptable, and appropriate. Thematic analysis and descriptive statistics were used for analysis.

RESULTS: The quantitative and qualitative results indicate that the intervention was perceived as acceptable and appropriate. However, the progression criteria for feasibility were not fully met. Qualitative findings show that the intervention was perceived as interesting, fun, and created curiosity to learn more about EBP. The discussions between the committee and the representatives from the social services department were much valued.

CONCLUSIONS: Careful anchoring of the intervention and comprehensive local adaptation regarding delivery format will be central to the delivery of this intervention if offered elsewhere. Furthermore, we recommend that skills training during the intervention should be included. The collaboration between local politicians and representatives from the social services department was a vital aspect of the intervention and should not be excluded. Collaboration between these actors will be of significance in further developing support for EBP implementation, as expressed by the interview participants.

PMID:36028906 | DOI:10.1186/s40814-022-01154-5

Int J Retina Vitreous. 2022 Aug 26;8(1):57. doi: 10.1186/s40942-022-00406-z.

ABSTRACT

BACKGROUND: To analyze the changes in foveal avascular zone (FAZ) area, perimeter, and circularity in the superficial (SCP) and deep (DCP) capillary plexuses in eyes with diabetic macular edema (DME) treated with intravitreal anti-VEGF using optical coherence tomography angiography (OCTA).

METHODS: This prospective observational study included 56 eyes from 32 patients with DME that received intravitreal anti-VEGF. OCTA images were obtained at baseline and 1, 3, and 6 months of follow-up. The outcome measures were FAZ area, perimeter, and circularity in both the SCP and DCP, as well as central subfield thickness (CST) and best-corrected visual acuity (BCVA).

RESULTS: The mean number of intravitreal anti-VEGF injections received during the observation period was 4.60 ± 0.82 (range: 3-6). The FAZ area, perimeter, and circularity were statistically unchanged at all observation points in both the SCP (p = 0.772, p = 0.405, p = 0.157, respectively) and the DCP (p = 0.620, p = 0.769, p = 0.481, respectively). Despite having no change in the FAZ parameters, there was still a statistically significant decrease in CST (p < 0.001) as well as a statistically significant increase in BCVA (p = 0.004) during the observation period.

CONCLUSIONS: The FAZ area, perimeter, and circularity in the SCP and DCP as measured by OCTA remained stable during the first 6 months of intravitreal anti-VEGF therapy in eyes with DME. While there were no significant changes in the FAZ, treatment with intravitreal anti-VEGF still resulted in decreased CST and improved BCVA.

PMID:36028899 | DOI:10.1186/s40942-022-00406-z

Breast Cancer Res. 2022 Aug 26;24(1):57. doi: 10.1186/s13058-022-01555-7.

ABSTRACT

BACKGROUND: Predictive biomarkers are needed to identify oestrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER + /HER2-) metastatic breast cancer (MBC) patients who would likely benefit from cyclin-dependent kinase 4 and 6 inhibitors combined with endocrine therapy. Therefore, we performed an exploratory study to evaluate the tumour heterogeneity parameters based on 16α-¹⁸F-fluoro-17β-oestradiol (¹⁸F-FES)-PET imaging as a potential marker to predict progression-free survival (PFS) in MBC patients receiving palbociclib combined with endocrine therapy.

METHODS: Fifty-six ER + MBC patients underwent ¹⁸F-FES-PET/CT before the initiation of palbociclib. ¹⁸F-FES uptake was quantified and expressed as the standardized uptake value (SUV). Interlesional heterogeneity was qualitatively identified according to the presence or absence of ¹⁸F-FES-negative lesions. Intralesional heterogeneity was measured by the SUV-based heterogeneity index (HI = SUVmax/SUVmean). Association with survival was evaluated using the Cox proportional hazards model.

RESULTS: A total of 551 metastatic lesions were found in 56 patients: 507 lesions were identified as ¹⁸F-FES-positive, 38 lesions were distributed across 10 patients without ¹⁸F-FES uptake, and the remaining 6 were liver lesions. Forty-three patients obtained a clinical benefit, and 13 developed progressive disease (PD) within 24 weeks. Nine out of 10 patients with an ¹⁸F-FES-negative site developed PD, and the median PFS was only 2.4 months. Among 46 patients with only ¹⁸F-FES-positive lesions, only four patients had PD, and the median PFS was 23.6 months. There were statistically significant differences between the two groups (P < 0.001). For the subgroup of patients with only ¹⁸F-FES-positive lesions, low FES-HI patients experienced substantially longer PFS times than those with high FES-HI (26.5 months vs. 16.5 months, P = 0.004).

CONCLUSIONS: ¹⁸F-FES-PET may provide a promising method for identifying and selecting candidate ER + /HER2- MBC patients who would most likely benefit from palbociclib combined with endocrine treatment and could serve as a predictive marker for treatment response. Trial registration NCT04992156, Date of registration: August 5, 2021 (retrospectively registered).

PMID:36028895 | DOI:10.1186/s13058-022-01555-7

J Int AIDS Soc. 2022 Aug;25(8):e25969. doi: 10.1002/jia2.25969.

ABSTRACT

INTRODUCTION: In 2018, the National AIDS and sexually transmitted infection (STI) Control Programme developed a national guidelines to facilitate the inclusion of young women who sell sex (YWSS) in the HIV prevention response in Kenya. Following that, a 1-year pilot intervention, where a package of structural, behavioural and biomedical services was provided to 1376 cisgender YWSS to address their HIV-related risk and vulnerability, was implemented.

METHODS: Through a mixed-methods, pre/post study design, we assessed the effectiveness of the pilot, and elucidated implementation lessons learnt. The three data sources used included: (1) monthly routine programme monitoring data collected between October 2019 and September 2020 to assess the reach and coverage; (2) two polling booth surveys, conducted before and after implementation, to determine the effectiveness; and (3) focus group discussions and key informant interviews conducted before and after intervention to assess the feasibility of the intervention. Descriptive analysis was performed to produce proportions and comparative statistics.

RESULTS: During the intervention, 1376 YWSS were registered in the programme, 28% were below 19 years of age and 88% of the registered YWSS were active in the last month of intervention. In the survey, respondents reported increases in HIV-related knowledge (61.7% vs. 90%, p <0.001), ever usage of pre-exposure prophylaxis (8.5% vs. 32.2%, p < 0.001); current usage of pre-exposure prophylaxis (5.3% vs. 21.1%, p<0.002); ever testing for HIV (87.2% vs. 95.6%, p <0.04) and any clinic visit (35.1 vs. 61.1, p <0.001). However, increase in harassment by family (11.7% vs. 23.3%, p<0.04) and discrimination at educational institutions (5.3% vs. 14.4%, p<0.04) was also reported. In qualitative assessment, respondents reported early signs of success, and identified missed opportunities and made recommendations for scale-up.

CONCLUSIONS: Our intervention successfully rolled out HIV prevention services for YWSS in Mombasa, Kenya, and demonstrated that programming for YWSS is feasible and can effectively be done through YWSS peer-led combination prevention approaches. However, while reported uptake of treatment and prevention services increased, there was also an increase in reported harassment and discrimination requiring further attention. Lessons learnt from the pilot intervention can inform replication and scale-up of such interventions in Kenya.

PMID:36028893 | DOI:10.1002/jia2.25969

Trials. 2022 Aug 26;23(1):707. doi: 10.1186/s13063-022-06603-3.

ABSTRACT

BACKGROUND: Severe dyspnea and poor quality of life are common in chronic obstructive pulmonary disease (COPD). The most important reason for this is wrong applications in inhaler treatment. In addition, inhaler treatments that support non-pharmacological methods increase the effectiveness of the drug. The aim of this study was to determine the effects of breathing exercises and inhaler training for chronic obstructive pulmonary disease patients on the severity of dyspnea and life quality.

METHODS: The research was a randomized controlled trial. A total of 67 patients with COPD were included. The patients were randomized into two groups. Intervention group 1 were given pursed lip breathing exercise and inhaler training and Intervention group 2 were given only inhaler training. A follow-up after 4 weeks was carried out in both groups. Patient outcomes in both groups were assessed by a COPD assessment test (CAT), the Modified Medical Research Council (mMRC) scale, and the St. George’s Respiratory Questionnaire scale (SGRQ). This study followed the CONSORT checklist for randomized controlled trials. In the data analysis, independent t, Mann-Whitney U, ANOVA, Wilcoxon analysis, and Pearson chi-square tests were used.

RESULTS: The pursed lips exercise and inhaler drug use skills of patients in both groups increased (p<0.001). The median value of the CAT and mMRC scores were statistically significant for both groups (p<0.005). The mean of life quality scores of patients in both groups decreased, and this result was found to be statistically significant in all sub-dimensions and in the total scale score for both groups (p<0.001). Although the increase in the quality of life and the decrease in the severity of dyspnea of the patients in both groups were significant, neither group was superior to the other (p>0.05).

CONCLUSIONS: As a result of the study, it was found that the skill of using the inhaler and the life quality of the patients increased, and the severity of dyspnea decreased. Supporting inhaler treatments with non-pharmacological methods can increase drug efficacy and quality of life.

TRIAL REGISTRATION: ClinicalTrials.gov NCT04739488. Registered on 21 Feb 2021.

PMID:36028881 | DOI:10.1186/s13063-022-06603-3

BMC Complement Med Ther. 2022 Aug 26;22(1):226. doi: 10.1186/s12906-022-03675-1.

ABSTRACT

BACKGROUND: Delay in episiotomy wound healing can lead to infection. The application of natural antimicrobial agents isolated from herbal essences can be a good strategy to prevent the growth of bacteria and promote the wound healing process. Therefore, this study aimed to determine the effect of rosemary cream on episiotomy wound healing in primiparous women.

METHODS: This triple-blind randomized clinical trial was conducted on 80 primiparous pregnant women who were referred to the maternity ward of Shahid Motahari Hospital in Marvdasht, Iran, from September 2019 to March 2020. These women were randomly assigned into two groups of intervention (rosemary cream) and control (placebo), using variable quadruple blocks. Both groups applied the prescribed cream (in a dose of 2 cm) uniformly on the sutured area to cover it with the cream. The cream was applied twice a day for 10 consecutive days postpartum, and the rate of wound healing was evaluated by the researcher in the first 12 h and at days 4 and 10 postpartum using the REEDA scale. The data were analyzed using SPSS software (Version 19) through the Chi-square test, Mann-Whitney U test, student’s t-test, and Fisher’s test. A p-value less than 0.05 (P < 0.05) was considered statistically significant.

RESULTS: The mean ± SD REEDA score on the fourth day postpartum was obtained at 3.82 ± 0.93 and 4.25 ± 1.29 in the groups of rosemary cream and placebo, respectively (P = 0.17). However, the mean ± SD REEDA scores on the 10th day postpartum were determined at 0.75 ± 0.74 and 3.32 ± 2.54 in the rosemary cream and placebo groups, respectively, indicating a higher rate of episiotomy wound healing in the group of rosemary cream compared to placebo (P < 0.001).

CONCLUSION: Based on the obtained results, it seems that rosemary cream can be effective in healing episiotomy wounds in primiparous women. However, further studies are suggested to confirm the findings of this study.

TRIAL REGISTRATION: This trial was registered in the Iranian Registry of Clinical Trials in 24/08/2019 with the IRCT ID: IRCT20190308042971N1. The first participant enrolled in this trial in September 2019. URL of registry: https://en.irct.ir/trial/40092 .

PMID:36028878 | DOI:10.1186/s12906-022-03675-1

Ital J Pediatr. 2022 Aug 26;48(1):155. doi: 10.1186/s13052-022-01343-1.

ABSTRACT

BACKGROUND: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic has been challenging health care systems and made it necessary to use rapid and cost-effective testing methods, particularly in Emergency Department (ED) settings. Rapid Antigen Diagnostic Tests (RADTs) are a valid alternative to the gold standard RT-PCR, even in pediatric populations. This retrospective observational study has been conducted on a pediatric cohort afferent to the ED of the San Giovanni di Dio and Ruggi d’Aragona University Hospital in Salerno, tested at Point of Care with RADT Panbio® (Abbott), from September 1^st, 2021 to February 28^th, 2022, analyzing the positivity rate and clinical features of the cohort, also in reference to the rise of positive cases observed in the aforementioned period, and to the introduction in Italy of SARS-CoV-2 vaccination for children and teens on December 16^th, 2021.

METHODS: Data regarding access to the pediatric ED were extracted from the hospital’s electronic database system. Parallel to this, we conducted a narrative literature search using PubMed database focusing on the use of RADT in pediatric ED and compared our data with the national pandemic trend.

RESULTS: During the observation period, 1890 patients were tested for the presence of SARS-CoV-2 with RADT and the 2.7% of children resulted positive, with a peak in January 2022. The main symptoms in positive patients were: fever (n = 34; 66.7%), cough (n = 11; 21.5%), headache (n = 4; 7.8%), chest pain (n = 2; 3.9%) and abdominal pain (n = 1; 2%). Patients were divided into three different age groups (A, B, C) basing on the different access timing to vaccination; no statistically significant difference was detected in the distribution of positivity in these three groups (p > 0.05). Number of positive children in group A was greater in the post-vaccine group. Our data are concordant with the national trend of the pandemic showing a fourth wave peak in January 2022.

CONCLUSION: The use of RADT as a first point-of-care screening may be helpful, time-saving and cost-sparing. Our study shows that, during the observation period, most children admitted to the ED for fever, actually tested positive for SARS-CoV-2 with a statistically greater difference than negative children. Instead, number of patients admitted for cough was statistically higher among negative than positive ones, probably due to the circulation of other respiratory viruses in children.

PMID:36028877 | DOI:10.1186/s13052-022-01343-1

Implement Sci. 2022 Aug 26;17(1):57. doi: 10.1186/s13012-022-01232-5.

ABSTRACT

BACKGROUND: Evidence-based interventions that optimize physical function for disabled and older adults living in the community who have difficulty with daily living tasks are available. However, uptake has been limited, particularly in resource-constrained (Medicaid) settings. Facilitation may be an effective implementation strategy. This study’s aim was to compare internal facilitation (IF) versus IF and external facilitation (EF) on adoption and sustainability of an intervention in a Medicaid home and community-based waiver.

METHODS: In a hybrid type 3 trial, waiver sites (N = 18) were randomly assigned to implement the intervention using a bundle of strategies with either IF or IF and EF. Adoption and sustainability were assessed via Stages of Implementation Completion (SIC) for each site. Clinician attitudes toward evidence-based practice and self-efficacy were evaluated among 539 registered nurses, social workers, and occupational therapists. Medicaid beneficiary outcomes of activities of daily living, depression, pain, falls, emergency department visits, and hospitalizations were evaluated in a sample of N = 7030 as reflected by electronic health records data of the Medicaid waiver program. Linear mixed-effects models were used to compare outcomes between trial arms while accounting for cluster-randomized design.

RESULTS: The mean SIC scores were 72.22 (standard deviation [SD] = 16.98) in the IF arm (9 sites) and 61.33 (SD = 19.29) in the IF + EF arm (9 sites). The difference was not statistically significant but corresponded to the medium clinically important effect size Cohen’s d = 0.60. Clinician implementation outcomes of attitudes and self-efficacy did not differ by trial arm. Beneficiary depression was reduced significantly in the IF + EF arm compared to the IF arm (p = .04, 95% confidence interval for the difference [0.01, 0.24]). No differences between trial arms were found for other beneficiary outcomes.

CONCLUSIONS: Level of facilitation did not enhance capacity for adoption and sustainability of an evidence-based intervention in a Medicaid setting that cares for disabled and older adults. Improved beneficiary depression favored use of IF and EF compared to IF alone, and no differences were found for other outcomes. These findings also suggest level of facilitation may not have impacted beneficiary outcomes.

TRIAL REGISTRATION: ClinicalTrials.gov , NCT03634033 ; date registered August 16, 2018.

PMID:36028873 | DOI:10.1186/s13012-022-01232-5

BMC Endocr Disord. 2022 Aug 26;22(1):214. doi: 10.1186/s12902-022-01121-4.

ABSTRACT

OBJECTIVE: The internal workings ofmachine learning algorithms are complex and considered as low-interpretation “black box” models, making it difficult for domain experts to understand and trust these complex models. The study uses metabolic syndrome (MetS) as the entry point to analyze and evaluate the application value of model interpretability methods in dealing with difficult interpretation of predictive models.

METHODS: The study collects data from a chain of health examination institution in Urumqi from 2017 ~ 2019, and performs 39,134 remaining data after preprocessing such as deletion and filling. RFE is used for feature selection to reduce redundancy; MetS risk prediction models (logistic, random forest, XGBoost) are built based on a feature subset, and accuracy, sensitivity, specificity, Youden index, and AUROC value are used to evaluate the model classification performance; post-hoc model-agnostic interpretation methods (variable importance, LIME) are used to interpret the results of the predictive model.

RESULTS: Eighteen physical examination indicators are screened out by RFE, which can effectively solve the problem of physical examination data redundancy. Random forest and XGBoost models have higher accuracy, sensitivity, specificity, Youden index, and AUROC values compared with logistic regression. XGBoost models have higher sensitivity, Youden index, and AUROC values compared with random forest. The study uses variable importance, LIME and PDP for global and local interpretation of the optimal MetS risk prediction model (XGBoost), and different interpretation methods have different insights into the interpretation of model results, which are more flexible in model selection and can visualize the process and reasons for the model to make decisions. The interpretable risk prediction model in this study can help to identify risk factors associated with MetS, and the results showed that in addition to the traditional risk factors such as overweight and obesity, hyperglycemia, hypertension, and dyslipidemia, MetS was also associated with other factors, including age, creatinine, uric acid, and alkaline phosphatase.

CONCLUSION: The model interpretability methods are applied to the black box model, which can not only realize the flexibility of model application, but also make up for the uninterpretable defects of the model. Model interpretability methods can be used as a novel means of identifying variables that are more likely to be good predictors.

PMID:36028865 | DOI:10.1186/s12902-022-01121-4

J Hematol Oncol. 2022 Aug 26;15(1):116. doi: 10.1186/s13045-022-01333-0.

ABSTRACT

BACKGROUND: Patients with chronic lymphocytic leukemia (CLL) may be more susceptible to COVID-19 related poor outcomes, including thrombosis and death, due to the advanced age, the presence of comorbidities, and the disease and treatment-related immune deficiency. The aim of this study was to assess the risk of thrombosis and bleeding in patients with CLL affected by severe COVID-19.

METHODS: This is a retrospective multicenter study conducted by ERIC, the European Research Initiative on CLL, including patients from 79 centers across 22 countries. Data collection was conducted between April and May 2021. The COVID-19 diagnosis was confirmed by the real-time polymerase chain reaction (RT-PCR) assay for SARS-CoV-2 on nasal or pharyngeal swabs. Severe cases of COVID-19 were defined by hospitalization and the need of oxygen or admission into ICU. Development and type of thrombotic events, presence and severity of bleeding complications were reported during treatment for COVID-19. Bleeding events were classified using ISTH definition. STROBE recommendations were used in order to enhance reporting.

RESULTS: A total of 793 patients from 79 centers were included in the study with 593 being hospitalized (74.8%). Among these, 511 were defined as having severe COVID: 162 were admitted to the ICU while 349 received oxygen supplementation outside the ICU. Most patients (90.5%) were receiving thromboprophylaxis. During COVID-19 treatment, 11.1% developed a thromboembolic event, while 5.0% experienced bleeding. Thrombosis developed in 21.6% of patients who were not receiving thromboprophylaxis, in contrast to 10.6% of patients who were on thromboprophylaxis. Bleeding episodes were more frequent in patients receiving intermediate/therapeutic versus prophylactic doses of low-molecular-weight heparin (LWMH) (8.1% vs. 3.8%, respectively) and in elderly. In multivariate analysis, peak D-dimer level and C-reactive protein to albumin ratio were poor prognostic factors for thrombosis occurrence (OR = 1.022, 95%CI 1.007‒1.038 and OR = 1.025, 95%CI 1.001‒1.051, respectively), while thromboprophylaxis use was protective (OR = 0.199, 95%CI 0.061‒0.645). Age and LMWH intermediate/therapeutic dose administration were prognostic factors in multivariate model for bleeding (OR = 1.062, 95%CI 1.017-1.109 and OR = 2.438, 95%CI 1.023-5.813, respectively).

CONCLUSIONS: Patients with CLL affected by severe COVID-19 are at a high risk of thrombosis if thromboprophylaxis is not used, but also at increased risk of bleeding under the LMWH intermediate/therapeutic dose administration.

PMID:36028857 | DOI:10.1186/s13045-022-01333-0