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Nevin Manimala Statistics

Clinical study of vacuum phenomenon in closed pelvic fracture

J Orthop Surg Res. 2023 Mar 25;18(1):241. doi: 10.1186/s13018-023-03674-z.

ABSTRACT

BACKGROUND: This study aimed to examine the prevalence and clinical findings of the vacuum phenomenon (VP) in closed pelvic fractures.

METHODS: We retrospectively reviewed 352 patients with closed pelvic fractures who presented to our institution from January 2017 to December 2020. Pelvic fractures were diagnosed by plain radiography and computed tomography (CT). The default “bone window” was used for inspection in the cross section. Electronic medical records were consulted by two orthopedic physicians to obtain patient information. The VP of pelvic fracture, fracture classification, injury mechanism, and image data were evaluated, and the demographic parameter data were statistically analyzed. The follow-up time was 12-18 months.

RESULTS: Among them, 169 were males and 183 were females with ages ranging from 3 to 100 years, with an average of 49.6 ± 19.3 years. VP in pelvic fractures was detected by CT in 109 (31%) of the 352 patients with pelvic fractures. Patients were divided into the high-energy trauma group (278 cases) and fragility fractures of the pelvis (FFP) group (74 cases) according to the injury mechanism. In the high-energy trauma group, 227 cases were treated surgically and 201 cases had bony healing. The healing time was 9.8 ± 5.3 weeks. In the FFP group, 54 cases were treated surgically and 49 cases had bone healing. The healing time was 9.3 ± 3.8 weeks. Fractures progressed in nine patients. VP was mostly located in the sacroiliac joint in our study.

CONCLUSIONS: The incidence of VP in pelvic fractures is statistically high and is affected by many factors, such as examination technique, joint position, population composition, etc. Therefore, the VP is not a reliable sign of pelvic injury. Clinically, we need to determine the nature of VP in conjunction with gas patterns, laboratory tests, history, and physical examination.

PMID:36964627 | DOI:10.1186/s13018-023-03674-z

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Serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (TAPS-2): statistical and qualitative analysis plan for a randomised controlled feasibility trial

Trials. 2023 Mar 24;24(1):225. doi: 10.1186/s13063-023-07235-x.

ABSTRACT

BACKGROUND: There are significant knowledge gaps regarding the effectiveness of serial prophylactic exchange blood transfusion (SPEBT) for pregnant women with sickle cell disease (SCD). The protocol for the randomised feasibility trial assessing SPEBT versus usual care in women with SCD (TAPS2 trial) has previously been published. This publication outlines the statistical and qualitative analysis plan for the study.

METHODS AND DESIGN: TAPS2 is a randomised two-arm phase 2 feasibility trial with a nested qualitative study and health economic evaluation. Up to 50 pregnant women with SCD and a singleton pregnancy will be recruited and individually randomised to either SPEBT approximately every 6-10 weeks until delivery (intervention arm) or to usual care (control arm). Information will be collected on a range of feasibility and clinical outcomes.

RESULTS: Due to the impact of COVID-19 on study recruitment, the initial study period of 24 months was extended to 48 months. Other protocol updates designed to mitigate the impact of COVID-19-related disruption included allowing for remote consent and conducting all qualitative interviews by telephone. The primary outcome for the trial is the overall recruitment rate. The number of women screened, eligible, consented, randomised and withdrawn will be summarised as a CONSORT flow diagram. Differences in clinical outcomes will additionally be presented as an initial assessment of efficacy and to inform sample size calculations for a future definitive trial. Qualitative interviews with trial participants and clinicians will be analysed using reflexive thematic analysis; data from interviews with participants who declined to participate in the trial will be extracted and incorporated into summary tables to report key findings. The health economic analysis plan is not covered by this update.

CONCLUSION: The publication of this analysis plan is designed to aid transparency and to reduce the potential for reporting bias.

TRIAL REGISTRATION: NIH registry ( www.

CLINICALTRIALS: gov ), registration number NCT03975894 (registered 05/06/19); ISRCTN ( www.isrctn.com ), registration number ISRCTN52684446 (retrospectively registered 02/08/19).

PMID:36964626 | DOI:10.1186/s13063-023-07235-x

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Psychometric evaluation of the Indolent Systemic Mastocytosis Symptom Assessment Form (ISM-SAF©) and determination of a threshold score for moderate symptoms

Orphanet J Rare Dis. 2023 Mar 25;18(1):69. doi: 10.1186/s13023-023-02661-1.

ABSTRACT

BACKGROUND: The Indolent Systemic Mastocytosis Symptom Assessment Form (ISM-SAF) (©Blueprint Medicines Corporation), a 12-item daily diary that assesses 11 signs and symptoms of indolent systemic mastocytosis (ISM) and smoldering systemic mastocytosis (SSM), was psychometrically evaluated among patients with ISM. Additionally, thresholds of the ISM-SAF total symptom score (TSS) to distinguish patients with moderate to severe symptoms from those with mild symptoms were evaluated.

METHODS: The ISM-SAF was completed daily as an electronic diary in a prospective, observational study utilizing an online survey of patients with ISM in the United States. Descriptive statistics, psychometric analyses, and analyses to estimate ISM-SAF TSS clinical cutoff values were conducted.

RESULTS: A total of 103 patients (81.6% female; mean age = 50.2 [± 12.6]) with a self-reported diagnosis of ISM or SSM (58 of whom also had a medically documented diagnosis) contributed to the analyses. Psychometric analysis supported the trustworthiness of the biweekly TSS, which was reliable (α > 0.8, ICC > 0.9), construct-valid, and able to distinguish among clinically distinct groups as specified by the Patient Global Impression of Severity, 12-item Short-Form Health Survey, and Mastocytosis Quality of Life Questionnaire (p < 0.01). A biweekly ISM-SAF TSS from 21 to 28 begins to distinguish the moderately to severely symptomatic ISM/SSM patients from mildly symptomatic patients.

CONCLUSION: The biweekly TSS of ISM-SAF was reliable, construct-valid, and able to distinguish among clinically distinct groups. A cut-off value of 28 is a conservative threshold that can be used for screening purposes in future clinical studies to identify patients with at least a moderate severity of ISM symptoms.

PMID:36964624 | DOI:10.1186/s13023-023-02661-1

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A focused review of statistical practices for relating radiation dose-volume exposure and toxicity

Radiat Oncol. 2023 Mar 24;18(1):57. doi: 10.1186/s13014-023-02220-9.

ABSTRACT

PURPOSE: Relating dose-volume histogram (DVH) information to patient outcomes is critical for outcomes research in radiation oncology, but this is statistically challenging. We performed this focused review of DVH toxicity studies to characterize current statistical approaches and determine the need for updated reporting recommendations.

METHODS AND MATERIALS: We performed a focused MEDLINE search to identify studies published in 5 radiation oncology specialty journals that associated dosimetry with toxicity outcomes in humans receiving radiotherapy between 2015 and 2021. Elements abstracted from each manuscript included the study outcome, organs-at-risk (OARs) considered, DVH parameters analyzed, summary of the analytic approach, use of multivariable statistics, goodness-of-fit reporting, completeness of model reporting, assessment of multicollinearity, adjustment for multiple comparisons, and methods for dichotomizing variables. Each study was also assessed for sufficient reporting to allow for replication of results.

RESULTS: The MEDLINE search returned 2,300 studies for review and 325 met the inclusion criteria for the analysis. DVH variables were dichotomized using cut points in 154 (47.4%) studies. Logistic regression (55.4% of studies) was the most common statistical method used to relate DVH to toxicity outcomes, followed by Cox regression (20.6%) and linear regression (12.0%). Multivariable statistical tests were performed in 226 (69.5%) studies; of these, the possibility of multicollinearity was addressed in 47.8% and model goodness-of-fit were reported in 32.6%. The threshold for statistical significance was adjusted to account for multiple comparisons in 41 of 196 (17.1%) studies that included multiple statistical comparisons. Twenty-eight (8.6%) studies were classified as missing details necessary to reproduce the study results.

CONCLUSIONS: Current practices of statistical reporting in DVH outcomes suggest that studies may be vulnerable to threats against internal and external validity. Recommendations for reporting are provided herein to guard against such threats and to promote cohesiveness among radiation oncology outcomes researchers.

PMID:36964622 | DOI:10.1186/s13014-023-02220-9

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Comparison of echocardiographic parameters of amputee football players with active football players and sedentary individuals

BMC Sports Sci Med Rehabil. 2023 Mar 24;15(1):41. doi: 10.1186/s13102-023-00651-1.

ABSTRACT

BACKGROUND: The purpose of this study is to compare the echocardiographic (ECHO) parameters of amputee football players (AF) with those of athletes without a disability (football players) (FP), and sedentary individuals (SI).

METHODS: A total of 37 male participants (nAF = 12, nFP = 12, nSI = 13) were included in the study. All participants underwent a transthoracic echocardiographic examination. Aortic diameter in systole (ADs), aortic diameter in diastole (ADd), isovolumic contraction time (IVCT), isovolumic relaxation time (IVRT), left ventricular ejection fraction (LVEF), early (E) and late (A) wave velocities, myocardial systolic (S), early diastolic (E’), and late diastolic (A’) myocardial rates, interventricular septal thickness (IVS), left ventricular end-diastolic diameter (LVDd) and left ventricular end-systole diameter (LVDs), left ventricular posterior wall thickness (LVPWd), left atrial diameter (LAD), and ascending aortic diameter (AAD) were measured.

RESULTS: LVDd, E’ were lower in AF than in FP. In contrast, LVDs, LVPWd, and A wave were higher in AF than in FP. When AF and SI groups were compared, ADs, LVPWd, A wave, IVRT, and S wave were higher in AF than in SI. ANOVA test showed a statistically significant difference between groups in LVPWd, A-wave, and E’ wave. TTE data indicate that some parameters in AF differ from those observed in healthy individuals. The smaller LVEED diameter and higher PWT were found in AF.

CONCLUSIONS: Although within normal limits, some ECHO parameters in the AF group differed from those without disability. Future studies should further investigate these differences using different and detailed measurement methods.

PMID:36964618 | DOI:10.1186/s13102-023-00651-1

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Precise acetabular positioning, discrepancy in leg length, and hip offset using a new seven-axis robot-assisted total hip arthroplasty system requires no learning curve: a retrospective study

J Orthop Surg Res. 2023 Mar 24;18(1):236. doi: 10.1186/s13018-023-03735-3.

ABSTRACT

OBJECTIVE: The purpose of the present study was to determine the learning curve for a novel seven-axis robot-assisted total hip arthroplasty (RA-THA) system, and to explore whether it was able to provide greater accuracy in acetabular cup positioning, superior leg length discrepancy (LLD), and hip offset than conventional methods.

METHODS: A total of 160 patients in which unilateral THA was performed in the second affiliated Hospital of Xi’an Jiaotong University from July 2021 to September 2022 were studied. The first 80 patients underwent robot-assisted THA, while conventional THA was performed on the subsequent 80 by the same team of experienced surgeons. The learning curve for the RA-THA system was evaluated using cumulative sum (CUSUM) analysis. The demographic data, preoperative clinical data, duration of surgery, postoperative Harris hip score (HHS) and postoperative radiographic data from patients that had conventional THA were compared.

RESULTS: The 80 patients who underwent primary unilateral RA-THA comprised 42 males and 38 females and were followed up for 12 weeks. Using analysis by CUSUM, the learning curve of the RA-THA system could be divided into learning and proficiency phases, the former of which consisted of the first 17 cases. There was no significant difference between the learning and proficiency phases in terms of LLD, hip offset, or accuracy of acetabular prosthesis position in the RA-THA groups. The proportion of acetabular prostheses located in the Lewinnek safe zone was 90.5% in the proficiency group and 77.5% in the conventional group, respectively, a difference that was statistically significant (P < 0.05). The absolute error between target angle and postoperative measured angle of anteversion was statistically significant in the proficiency group and the conventional group((P < 0.05). Postoperative acetabular anteversion and LLD were 19.96 ± 5.68° and 6.00 (5.00) mm in the proficiency group, respectively, and 17.84 ± 6.81° and 8.09 (4.33) mm using conventional surgery, respectively (anteversion: P = 0.049; LLD: P < 0.001).

CONCLUSIONS: The surgical team required a learning curve of 17 cases using the RA-THA system to become proficient. There was no learning curve for other parameters, namely LLD, hip offset, or accuracy of acetabular prosthesis positioning. During the proficiency phase, the RA system was superior to conventional THA for control of leg length and accuracy of acetabular cup placement.

PMID:36964615 | DOI:10.1186/s13018-023-03735-3

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The psychometric properties of Binge Eating Scale among overweight college students in Taiwan

J Eat Disord. 2023 Mar 25;11(1):47. doi: 10.1186/s40337-023-00774-3.

ABSTRACT

BACKGROUND: The Binge Eating Scale (BES) is a widely used measuring tool to assess binge eating problems in Western countries. However, the psychometric properties of such scales among cross-cultural youth groups are insufficient, and the factor structure continues to be debated; therefore, further research is needed. The aim of this study was to examine the properties of BES among overweight college students in Taiwan.

METHODS: A cross-sectional design and convenience sampling were adopted to recruit 300 overweight students from five universities. A translated Traditional Chinese version of BES was used for the survey, and the validity of the scale was tested using the Confirmatory Factor Analysis (CFA) and Bulimic Investigatory Test, Edinburgh (BITE). The reliability was evaluated using internal consistency and test-retest reliability.

RESULTS: The CFA results showed a reasonable model fit. The first-order two-factor model was consistent with that of the original BES and significantly correlated with the criterion of BITE score. Cronbach’s α value, representing internal consistency reliability, and the intraclass correlation coefficient of repeated measures made one month apart were both 0.83, indicating good reliability and stability. Significant correlations were observed between the BES score and sex and BMI; however, no correlation was observed between BES scores and age.

CONCLUSION: The BES presents sound psychometric properties, has good cross-cultural applicability, and can be used as a first-line screening tool by mental health professionals to identify the severity of binge eating behavior among overweight college students in Taiwan. It is recommended that participant diversity and obesity indicators be incorporated into the scale in the future to establish a universal psychometric tool.

PMID:36964612 | DOI:10.1186/s40337-023-00774-3

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Follow-up survey of general practitioners in Zhejiang Province post-completion of position transition training in 2017-2020

BMC Med Educ. 2023 Mar 24;23(1):182. doi: 10.1186/s12909-023-04151-1.

ABSTRACT

BACKGROUND: Position transition training for general practitioners in Zhejiang Province started in 2017 and has since been held once a year. By the beginning of 2022, four training sessions were completed. The purpose of this survey was to establish the current situation of trainees after their graduation and provide reference for the evaluation of the training effect.

METHODS: Of the 738 trainees who completed the training, 253 were contacted and followed up. A self-designed questionnaire was used to conduct the survey through online filling in. The content included questions to elucidate the following information: whereabouts after the training, registration as a general practitioner, undertaken general practice teaching and scientific research work, current occupational environment, improvement of post competence after receiving position transition training, willingness to complete survey, willingness to participate in future training programs, etc. RESULTS: A number of 253 valid questionnaires were collected with a recovery rate of 100%. Notably, 93.68% of the participants successfully completed their training and obtained the Training Certificate of General Practitioners. Further, 83.4% were registered as general practitioners, 82.94% of which added on the basis of the original registered scope of practice. Currently, most of them work in primary health care institutions, primarily occupied with medical treatment, chronic disease management, COVID-19 prevention and control, health education, and prevention and health care. Of them, 27.01% were currently undertaking teaching work, and only 3.32% of them were conducting scientific research work related to general practice. The overall satisfaction of the trainees in the three theoretical training bases was above 90%, with no statistically significant difference among them (P > 0.05). Importantly, 84.11% of the followed-up personnel hoped to continue to participate in similar training in the future to improve their general practitioner core competences.

CONCLUSION: The position transition training in Zhejiang Province has achieved good results, but the details of training and the implementation of policies in individual regions need to be improved. Most of the graduates were willing to continue their education, especially in general practitioners with special interests.

PMID:36964607 | DOI:10.1186/s12909-023-04151-1

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Evolution and lessons from an integrated service delivery network in North West Syria

Confl Health. 2023 Mar 24;17(1):12. doi: 10.1186/s13031-023-00510-3.

ABSTRACT

BACKGROUND: Northwest Syria (NWS) is a complex and extremely fragile operating environment, with more than 2.8 million people needing humanitarian assistance. To support a common standard of care delivery and enable coordination among the multiple providers in NWS, WHO developed an Essential Health Services package (EHSP) in 2016-17 and subsequently supported a facility network model to deliver the EHSP. This article provides an evaluation of the network to date, aiming to inform further development of the network and draw wider lessons for application of similar approaches in complex emergency settings.

METHODS: This mixed method study included document review, participatory, qualitative and quantitative data, gathered in the first half of 2021. Participatory data came from two group model building workshops with 21 funders and implementers. Semi-structured interviews with 81 funders, health professionals and community members were also conducted. Analyses of the workshops and interviews was inductive, however a deductive approach was used for synthesising insights across this and the document review. The final component was a survey of health providers (59 health care professionals) and service users (233 pregnant women and 214 persons living with NCDs) across network and other comparable facilities, analysed using routine descriptive and inferential statistics. Findings across all methods were triangulated.

RESULTS: The study finds that the network and its accompanying essential service package were relevant to the dynamic and challenging context, with high but shifting population needs and multiple uncoordinated providers. Judged in relation to its original goals of comprehensive, coordinated services, equitable access and efficient service delivery, the data indicate that gains have been made in all three areas through the network, although attribution is challenging, given the complex environment. The context remains challenging, with shifting boundaries and populations displaced by conflict, difficulties in retaining staff, the need to import medicines and supplies across borders, and governance gaps.

CONCLUSION: This study adds to a very limited literature on coordinated network approaches used to raise care quality and improve referrals and efficiency in a complex emergency setting. Although areas of ongoing challenge, including for sustainability, are noted, the network demonstrated some resilience strategies and can provide lessons for other similar contexts.

PMID:36964578 | DOI:10.1186/s13031-023-00510-3

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Exoskeleton-based training improves walking independence in incomplete spinal cord injury patients: results from a randomized controlled trial

J Neuroeng Rehabil. 2023 Mar 24;20(1):36. doi: 10.1186/s12984-023-01158-z.

ABSTRACT

BACKGROUND: In recent years, ambulatory lower limb exoskeletons are being gradually introduced into the clinical practice to complement walking rehabilitation programs. However, the clinical evidence of the outcomes attained with these devices is still limited and nonconclusive. Furthermore, the user-to-robot adaptation mechanisms responsible for functional improvement are still not adequately unveiled. This study aimed to (1) assess the safety and feasibility of using the HANK exoskeleton for walking rehabilitation, and (2) investigate the effects on walking function after a training program with it.

METHODS: A randomized controlled trial was conducted including a cohort of 23 patients with less than 1 year since injury, neurological level of injury (C2-L4) and severity (American Spinal Cord Injury Association Impairment Scale [AIS] C or D). The intervention was comprised of 15 one-hour gait training sessions with lower limb exoskeleton HANK. Safety was assessed through monitoring of adverse events, and pain and fatigue through a Visual Analogue Scale. LEMS, WISCI-II, and SCIM-III scales were assessed, along with the 10MWT, 6MWT, and the TUG walking tests (see text for acronyms).

RESULTS: No major adverse events were reported. Participants in the intervention group (IG) reported 1.8 cm (SD 1.0) for pain and 3.8 (SD 1.7) for fatigue using the VAS. Statistically significant differences were observed for the WISCI-II for both the “group” factor (F = 16.75, p < 0.001) and “group-time” interactions (F = 8.87; p < 0.01). A post-hoc analysis revealed a statistically significant increase of 3.54 points (SD 2.65, p < 0.0001) after intervention for the IG but not in the CG (0.7 points, SD 1.49, p = 0.285). No statistical differences were observed between groups for the remaining variables.

CONCLUSIONS: The use of HANK exoskeleton in clinical settings is safe and well-tolerated by the patients. Patients receiving treatment with the exoskeleton improved their walking independence as measured by the WISCI-II after the treatment.

PMID:36964574 | DOI:10.1186/s12984-023-01158-z