Category: Nevin Manimala

Pilot Feasibility Stud. 2023 Apr 15;9(1):59. doi: 10.1186/s40814-023-01291-5.

ABSTRACT

BACKGROUND: External randomised pilot trials aim to assess whether a future definitive Randomised Controlled Trial (RCT) is feasible. Prespecified progression criteria help guide the interpretation of pilot trial findings to decide whether, and how, a definitive RCT should be conducted. This commentary presents a set of proposed recommendations for progression criteria to guide researchers when (i) designing, (ii) conducting, (iii) analysing and (iv) reporting external randomised pilot trials.

METHODS: Recommendations were developed following a mixed methods approach. This involved (i) a methodological review of pilot trial publications, (ii) a cross-sectional study of pilot trial research funding applications, (iii) qualitative interviews with pilot trial researchers and (iv) a survey of corresponding authors of identified pilot trial publications. Initial recommendations were refined following two consultation stakeholder workshops held in July 2022. Recommendations for progression criteria for external randomised pilot trials: i.

DESIGN: consider progression criteria from the earliest opportunity; map progression criteria to feasibility objectives; consider quantitative and qualitative interpretations of feasibility; provide justification; develop guidelines rather than rules; seek input from relevant stakeholders. ii. Conduct: regularly monitor pilot trial data against progression criteria. iii.

ANALYSIS: avoid considering each progression criterion in isolation; engage in discussion with relevant stakeholders; consider context and other factors external to the pilot trial; consider feasibility (can we?) and progression (will we?). iv. Reporting: we propose a reporting checklist in relation to progression criteria and recommend reporting in a table format for clarity.

CONCLUSION: These recommendations provide a helpful resource for researchers to consider progression criteria at different stages of external randomised pilot trials. We have produced a simple infographic tool to summarise these recommendations for researchers to refer to. Further research is needed to evaluate whether these proposed recommendations should inform future development, or update, of established guidelines for the design, conduct, analysis and reporting of external randomised pilot trials.

PMID:37061720 | DOI:10.1186/s40814-023-01291-5

BMC Oral Health. 2023 Apr 15;23(1):218. doi: 10.1186/s12903-023-02944-w.

ABSTRACT

BACKGROUND: Autogenous soft tissue grafting is indicated in thin gingival biotypes before orthodontic proclination or labial movements to increase the keratinized gingiva and prevent gingival recession. However, its effect on local alveolar bone remodeling is unclear. The aim of this study was to investigate the effects of autogenous soft tissue grafting on local alveolar bone after orthodontic proclination or labial movements.

METHODS: Sixteen patients with a thin scalloped gingival biotype, narrow keratinized gingiva, or thin cortical bone requiring orthodontic proclination or labial movement of teeth were included. Cone-beam computed tomography (CBCT) images were obtained before grafting and at least 6 months after surgery. Sixty mandibular teeth were included, and the vertical bone level and horizontal labial bone thickness were measured. The results were compared using paired t-tests or Wilcoxon signed-rank test.

RESULTS: The horizontal labial bone thickness increased, especially at 6 mm below the cementoenamel junction (CEJ) in the mandibular central and lateral incisors (P < 0.05). The total alveolar bone area of the canines, first premolars, and second premolars increased at 3, 6, and 9 mm below the CEJ, respectively, and the differences were statistically significant (P < 0.05). Additionally, vertical bone height increased minimally on the labial side, but the differences were not statistically significant (P > 0.05).

CONCLUSIONS: New bone regeneration was observed on the labial (pressure) side after autogenous soft tissue grafting, which may represent a mechanism to effectively prevent gingival recession and maintain periodontal health.

IRB APPROVAL: All the experimental procedures involving humans in this study were approved by the Medical Ethics Committee of Xiangya Stomatological Hospital, Central South University ( No. 20190048).

PMID:37061689 | DOI:10.1186/s12903-023-02944-w

BMC Womens Health. 2023 Apr 15;23(1):180. doi: 10.1186/s12905-023-02325-z.

ABSTRACT

BACKGROUND: Male out-migration is negatively associated with contraceptive use in developing countries. This study aimed to examine the effect of male out-migration on the contraceptive behaviour of women in the Middle-Ganga Plain (MGP) region.

METHODS: The data has been collected from the Middle-Ganga Plain survey (2018-19), which was conducted by the International Institute for Population Sciences (IIPS). The overall sample size was 1314 wives left behind and 1402 non-migrant wives. Multivariate logistic regression analysis was used to examine the relationship between the variables. Statistical analyses were done using SPSS version 25.

RESULT: The result shows that female sterilization was the most common method used by both left behind wives (30.9%) and non-migrant wives (34.6%). Most of the left-behind women didn’t use contraception because their husbands were away from home (30.86%). The result also shows that left behind wives were less likely to use any methods of contraception than the non-migrant wives. Left behind women were more tended to use the modern methods (OR-0.71, 95%CI = 0.57-0.88) than any traditional methods (OR-0.61, 95% CI = 0.46-0.80). Age, religion, family type, working status, and marital duration were strongly associated with women’s contraceptive use.

CONCLUSION: These results strengthen the existing literature that explains how migration affects women’s health. Therefore, there is an important need to develop and implement comprehensive education programs and policy on contraception use.

PMID:37061675 | DOI:10.1186/s12905-023-02325-z

BMC Oral Health. 2023 Apr 15;23(1):217. doi: 10.1186/s12903-023-02939-7.

ABSTRACT

BACKGROUND: This study was using Cone beam computed tomography (CBCT) to examine the anatomical variations in mandibular second molars in an Egyptian sub-population.

METHODS: A total of 350 CBCT images (215 females and 135 males, aged 15-65 years) of mandibular second molars were evaluated. Samples were evaluated in terms of: number of roots, number of root canals, roots’ cross section as well as prevalence and configurations of C-shaped canals. Statistical analysis was done to highlight differences between different categories and their prevalence among genders (significance level was set at p < 0.05). Data were presented as frequency and percentage values and were analyzed using chi square test followed by pairwise comparisons utilizing multiple Fisher’s exact tests with Bonferroni correction. The significance level was set at p < 0.05 within all tests.

RESULTS: Of the 350 mandibular second molars evaluated, 87.2% were non-C-shaped while 12.8% were C-shaped with no gender-based statistically significant differences (χ2 = 0.19, p = 0.656). Most samples had three root canals (80%) followed by two (16%), then one (3.2%), and finally four (0.8%) root canals. Among the non-C-shaped molars, presence of two roots was most common (83.4%) followed by presence of a single root (16.2%), and only one sample (0.2%) had three roots, and this had no correlation with gender (χ2 = 1.86, p = 0.431). In the mesial roots Type IV Vertucci was the most common configuration found (68.8%), while Type I was the most prevalent in the distal roots (91.8%). The long oval configuration was the most commonly found cross section in mesial roots while “oval” was the most prevalent in distal roots.

CONCLUSION: Egyptian sub-population shows highly variable morphological features in mandibular second molars, hence, CBCT is highly recommended on case-to-case conditions.

PMID:37061674 | DOI:10.1186/s12903-023-02939-7

J Endocrinol Invest. 2023 Apr 15. doi: 10.1007/s40618-023-02095-3. Online ahead of print.

ABSTRACT

PURPOSE: To investigate the link between hematopoietic and skeletal tissues in patients with fragility fractures.

METHODS: We retrospectively analyzed the medical records of women older than 40 years who attended the Bone Disease Unit of “Sapienza” University of Rome for their first visit for osteoporosis from January 2020 to June 2022.

RESULTS: Fragility fractures were found in 61.8% of the sample. In particular, vertebral fractures in 35.5%, femoral fractures in 6.3%, Colles fractures in 16.5% and non-vertebral non-hip in 42.5%. Fractured patients were significantly older compared to non-fractured, had lower mean values of lumbar spine (p = 0.01), and femoral neck BMD (p = 0.007). A red blood cell distribution width (RDW) value higher than 15% was observed four times more in those with fractures compared to non-fractured patients (8.9% vs 2%, p = 0.01) and was associated with vertebral fracture after adjusting for age, BMI, menopause, nutritional status, smoking, osteoporosis and anemia (OR = 4.1, 95% CI 1.6-11.4, p = 0.003). Hematocrit was negatively associated with hip fracture also adjusting for age, BMI, menopause, nutritional status, smoking, osteoporosis (p = 0.025).

CONCLUSION: Our study demonstrates that RDW values were significantly associated with vertebral fracture and hematocrit with hip fracture. Since both parameters are included in the initial evaluation of patients with suspected bone fragility, our results should push doctors to look at these values with no incremental cost for national health services.

PMID:37061647 | DOI:10.1007/s40618-023-02095-3

Sci Rep. 2023 Apr 15;13(1):6188. doi: 10.1038/s41598-023-33218-8.

ABSTRACT

This sentinel node (SN) biopsy trial aimed to assess its effectiveness in identifying predictive factors of micrometastases and to determine whether elective neck dissection is necessary in oral squamous cell carcinoma. This retrospective study included 55 patients from three previous trials, with positive SNs. The relationship between the sizes of the metastatic focus and metastasis in non-sentinel node (NSN) was investigated. Four of the 55 largest metastatic focus were isolated tumor cells, and the remaining 51 were ranged from 0.2 to 15 mm, with a median of 2.6 mm. The difference of prevalence between 46 negative- and 9 positive-NSN was statistically significant with regard to age, long diameter of primary site and number of cases with regional recurrence. In comparing the size of largest metastatic focus dividing the number of positive SN, with metastaic focus range of < 3.0 mm in one-positive SN group, there were 18 (33%) negative-NSN and no positive-NSN. Regarding prognosis, 3-year overall survival rate of this group (n = 18) and other (n = 37) were 94% and 73% (p = 0.04), and 3-year recurrence free survival rate of this group and other were 94% and 51% (p = 0.03), respectively. Absolutely a further prospective clinical trial would be needed, micrometastases may be defined as solitary SN metastasis with < 3.0 mm of metastatic focus, and approximately 33% of neck dissections could be avoided using these criteria.

PMID:37061623 | DOI:10.1038/s41598-023-33218-8

Am J Cardiovasc Drugs. 2023 Apr 15. doi: 10.1007/s40256-023-00580-x. Online ahead of print.

ABSTRACT

BACKGROUND: Atrial fibrillation (AF) frequently complicates hypertrophic cardiomyopathy (HCM), and anticoagulation significantly decreases the risk of stroke in this population. To date, no randomized controlled trials (RCTs) have compared direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs). The present study aimed to systematically compare the two anticoagulation strategies in terms of effectiveness and safety.

METHOD: We performed a systematic literature search and meta-analysis in the PubMed, MEDLINE, and EMBASE databases for studies reporting all-cause mortality, major bleeding, or thromboembolic events (TEs). Since no RCTs were available, we included observational studies only. The overall hazard ratio (HR) and 95% confidence interval (CI) for each analyzed parameter were pooled using a random-effects model.

RESULTS: Five observational studies including 6919 patients were eligible for inclusion. Compared with VKAs, DOACs were associated with statistically significant lower rates of all-cause mortality (HR 0.64, 95% CI 0.35-0.54; p < 0.00001), comparable major bleeding events (HR 0.64, 95% CI 0.40-1.03; p = 0.07), and TEs (HR 0.94, 95% CI 0.73-1.22; p = 0.65).

CONCLUSIONS: Compared with VKAs, a DOAC-based strategy might represent an effective and safe strategy regarding all-cause mortality, major/life-threatening bleeding complications, and TEs in HCM patients with concomitant AF. However, further prospective studies are necessary to reinforce a DOAC-based anticoagulation strategy in this population.

PMID:37061614 | DOI:10.1007/s40256-023-00580-x

Sci Rep. 2023 Apr 15;13(1):6139. doi: 10.1038/s41598-023-32668-4.

ABSTRACT

No cardiovascular risk score has included Latin American patients in its development. The ACC/AHA ASCVD risk score has not been validated in Latin America; consequently, its predictive capacity in the population of the region is unknown. The aim of this study is to evaluate the discrimination capacity and calibration of the ACC/AHA ASCVD score to predict the 10-year risk of a cardiovascular event in a primary prevention cohort followed in a Colombian hospital. A retrospective cohort study was conducted in primary prevention patients belonging to an intermediate/high-risk and low-risk cohort without established atherosclerotic disease. Cardiovascular risk was calculated at inclusion. The calibration was analyzed by comparing observed and expected events in the different risk categories. A discrimination analysis was made using the area under the ROC curve and C statistic. A total of 918 patients were included-202 from the intermediate/high-risk and 716 from the low-risk cohort. The median cardiovascular risk was 3.6% (IQR 1.7-8.5%). At the 10-year follow-up, 40 events (4,4%) occurred. The area under the ROC curve was 0.782 (95% CI 0.71-0.85). The Hosmer-Lemeshow test did not show differences between expected and observed events. The ACC/AHA ASCVD score is calibrated and has good discrimination capacity in predicting 10-year risk of cardiovascular events in a Colombian population.

PMID:37061603 | DOI:10.1038/s41598-023-32668-4

Forensic Sci Med Pathol. 2023 Apr 15. doi: 10.1007/s12024-023-00617-2. Online ahead of print.

ABSTRACT

There are many dental age estimation methods, but all the methods do not correspond, especially for aging methods for adults and mature individuals, to the reality of the forensic field, which favors simple, effective, and easy-to-use methods. Ruquet (2015) developed a method based on alveolar bone loss that predicts age for individuals between 25 and 60 years old and is even more accurate for those 25-40 years old. This study re-evaluated Ruquet’s alveolar bone loss method using three-dimensional imaging of individuals whose age and sex were known, without taking into account their medical conditions. Digital measurements, from the cemento-enamel junction (CEJ) to the alveolar bone crest (ABC), were performed on the mesial and distal surfaces of teeth on 243 patients, independent of the tridimensional imaging test. With these measurements, two alveolar bone loss averages (ABL) were calculated, one with all the teeth present on the arches and another with only Ramfjörd’s teeth. Bone loss showed a significant correlation with age (p < 0.001). The age estimation with all teeth and with only Ramfjörd’s teeth showed a statistically significant difference, and age estimation was more accurate when all teeth were used. The assessment of alveolar resorption appears to be an interesting tool for age estimation in adult individuals. However, the method still lacks precision, and the mean absolute errors (MAEs) obtained by age group were all greater than 5 years, except for the age group 35-39 years old, for the age estimation with all teeth. Further studies should explore this existing correlation between alveolar bone loss and age and refine this method to make it more accurate.

PMID:37061600 | DOI:10.1007/s12024-023-00617-2

Ann Biomed Eng. 2023 Apr 15. doi: 10.1007/s10439-023-03205-1. Online ahead of print.

NO ABSTRACT

PMID:37061596 | DOI:10.1007/s10439-023-03205-1