Tag: statistics

Asthma Res Pract. 2022 Aug 27;8(1):5. doi: 10.1186/s40733-022-00087-3.

ABSTRACT

BACKGROUND: Asthma is a major public health challenge and is characterized by recurrent attacks of breathlessness and wheezing that vary in severity and frequency from person to person. Asthma control is an important measure of health outcomes of the patients with asthma and reflecting the impact of an illness and its treatment from the patient’s perspective. Therefore, this study assessed the asthma control levels and their determinants among adults living with asthma in selected public referral hospitals in northwestern Ethiopia.

MATERIALS AND METHOD: A multicenter institutional-based cross-sectional study was conducted in North-western Ethiopia, from October to December 2021. A systematic random sampling technique was employed to recruit the study participants. Bi-variable and multivariable ordinal logistic regression was used to determine the independent predictors of asthma control levels. A p-value of < 0.05 was considered as statistically significant.

RESULT: A total of 409 patients were included in the final analysis. Asthma was controlled by 28.9% with 95%CI (24.7, 33.5) people who have asthma. Regarding the potential predictor of asthma control level, being male (AOR = 6.5, 95%CI (1.28, 32.44), Married (AOR = 3.62, 95%CI (1.28, 10.27), healthcare provider adherence to guideline usage (AOR = 8.4,95%CI (2.7, 26) and non-fuel users (AOR = 6.0, 95%CI (1.5, 22.5) were variables that increase asthma control. However, non-adherent to medication (AOR = 0.16, 95%CI (0.059, 0.48), low level of patient enablement (AOR = 0.19, (95%CI) (0.08, 0.49) and poor relationship with healthcare provider (AOR = 0.024,95%CI (0.02, 0.23) were variables that significantly decreased asthma control level.

CONCLUSION: The findings indicated that asthma control remains suboptimal in a large proportion of patients with asthma in the study setting. Socio-demographic, clinical, healthcare-related, and medication-related variables were significantly associated with asthma control. Therefore, our study highlights multifaceted interventions, including comprehensive asthma education along with an integrated treatment plan to improve asthma control and quality of life.

PMID:36028919 | DOI:10.1186/s40733-022-00087-3

Int J Retina Vitreous. 2022 Aug 26;8(1):59. doi: 10.1186/s40942-022-00410-3.

ABSTRACT

PURPOSE: To correlate the structural-vascular-functional changes in type 2 non-proliferative macular telangiectasia (MacTel) using optical coherence tomography (OCT) angiography (OCTA).

METHODS: In this retrospective study, OCTA and enface OCT image analysis of eyes with confirmed diagnosis of non-proliferative type 2 MacTel was performed. The ‘MacTel area’ was calculated by marking the outer boundary of an area affected by MacTel on superficial (SCP) and deep capillary plexus (DCP) on OCTA images and photoreceptor layer (PRL) on enface OCT scan. At every follow-up OCTA scan visit, best-corrected visual acuity, MacTel area and stage of disease was documented. Analyses between disease stage, MacTel area and logMAR visual acuity was carried out.

RESULTS: In total, 38 single-visit OCTA scans of 22 patients were included. The mean age was 58.9 ± 10.98 years. An increase in disease severity stage correlated positively with MacTel area in SCP segmentations slab (r = 0.334; p = 0.04) and logMAR visual acuity (r = 0.338; p = 0.038). No correlation in the DCP area or PRL area (p > 0.05) was noted with disease stage. A statistically significant positive correlation was noted between the structural changes in PRL layer with vascular changes in SCP (p = 0.021) but not in DCP (p = 0.199). No correlation of visual acuity with changes in SCP, DCP or PRL was noted (p > 0.05).

CONCLUSION: OCTA is a useful adjunct for determining disease severity in type 2 non-proliferative MacTel by assessing the structural-vascular changes. Further longitudinal studies need to be considered in future for understanding the pathomechanism of retinal damage in type 2 MacTel.

PMID:36028918 | DOI:10.1186/s40942-022-00410-3

Trials. 2022 Aug 26;23(1):715. doi: 10.1186/s13063-022-06574-5.

ABSTRACT

INTRODUCTION: To date, there is no consensus on which anterior surgical technique is more cost-effective in treating cervical degenerative disc disease (CDDD). The most commonly used surgical treatment for patients with single- or multi-level symptomatic CDDD is anterior cervical discectomy with fusion (ACDF). However, new complaints of radiculopathy and/or myelopathy commonly develop at adjacent levels, also known as clinical adjacent segment pathology (CASP). The extent to which kinematics, surgery-induced fusion, natural history, and progression of disease play a role in the development of CASP remains unclear. Anterior cervical discectomy with arthroplasty (ACDA) is another treatment option that is thought to reduce the incidence of CASP by preserving motion in the operated segment. While ACDA is often discouraged, as the implant costs are higher while the clinical outcomes are similar to ACDF, preventing CASP might be a reason for ACDA to be a more cost-effective technique in the long term.

METHODS AND ANALYSIS: In this randomized controlled trial, patients will be randomized to receive ACDF or ACDA in a 1:1 ratio. Adult patients with single- or multi-level CDDD and symptoms of radiculopathy and/or myelopathy will be included. The primary outcome is cost-effectiveness and cost-utility of both techniques from a healthcare and societal perspective. Secondary objectives are the differences in clinical and radiological outcomes between the two techniques, as well as the qualitative process surrounding anterior decompression surgery. All outcomes will be measured at baseline and every 6 months until 4 years post-surgery.

DISCUSSION: High-quality evidence regarding the cost-effectiveness of both ACDA and ACDF is lacking; to date, there are no prospective trials from a societal perspective. Considering the aging of the population and the rising healthcare costs, there is an urgent need for a solid clinical cost-effectiveness trial addressing this question.

TRIAL REGISTRATION: ClinicalTrials.gov NCT04623593. Registered on 29 September 2020.

PMID:36028916 | DOI:10.1186/s13063-022-06574-5

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