Category: Statistics

Radiat Oncol. 2022 Jul 29;17(1):134. doi: 10.1186/s13014-022-02099-y.

ABSTRACT

INTRODUCTION: Definitive chemoradiotherapy has established the standard non-surgical treatment for locally advanced esophageal cancer. The standard dose of 50-50.4 Gy has been established decades ago and been confirmed in modern trials. The theorical advantage of better local control and technical advances for less toxicity have encouraged clinicians for dose escalation investigation. ¹⁸F-fluorodeoxyglucose (¹⁸F-FDG) positron emission tomography/computed tomography (PET/CT) have the potential to tailor therapy for esophageal patients not showing response to CRT and pioneers the PET-based dose escalation.

METHODS AND ANALYSIS: The ESO-Shanghai 12 trial is a prospective multicenter randomized phase 3 study in which patients are randomized to either 61.2 Gy or 50.4 Gy of radiation dose by PET response. Both groups undergo concurrent chemoradiotherapy with paclitaxel/cisplatin regimen for 2 cycles followed by consolidation chemotherapy for 2 cycles. Patients with histologically confirmed ESCC [T1N1-3M0, T2-4NxM0, TxNxM1 (Supraclavicular lymph node metastasis only), (AJCC Cancer Staging Manual, 8th Edition)] and without any prior treatment of chemotherapy, radiotherapy or surgery against esophageal cancer will be eligible. The primary endpoints included overall survival in PET/CT non-responders (SUV_max > 4.0) and overall survival in total population. Patients will be stratified by standardized uptake volume, gross tumor volume and tumor location. The enrollment could be ended, when the number of PET/CT non-responder reached 132 and the total population reached 646 for randomization.

ETHICS AND DISSEMINATION: This trial has been approved by the Fudan University Shanghai Cancer Center Institutional Review Board. Trial results will be disseminated via peer reviewed scientific journals and conference presentations. Trial registration The trial was initiated in 2018 and is currently recruiting patients. Trial registration number NCT03790553.

PMID:35906623 | DOI:10.1186/s13014-022-02099-y

BMC Complement Med Ther. 2022 Jul 29;22(1):201. doi: 10.1186/s12906-022-03655-5.

ABSTRACT

BACKGROUND: The aim of this study was to evaluate the biological effects of hydroalcoholic extract of Psidium guajava L leaves and phenytoin as a standard agent on the induced oral mucosal wound.

METHODS: Hundred seventy Sprague Dawley rats were grouped in 5 clusters randomly. Oral mucosal wounds were induced in all rats except for the control group. Phenytoin and guajava leaf extract were used as a mouthwash. Twelve rats from the 5 groups were euthanized on day 7^th and 10^th, and 10 rats from each group were sacrificed on the 14^th day. Interleukin-6 and total antioxidant capacity were determined in the serum. The tissues were evaluated for pathological and stereological assessments. Phytochemical analyses were performed on the hydroalcoholic extract of Psidium guajava L to determine the antioxidant potency.

RESULTS: Total phenolic content test and DPPH analysis demonstrated the high potential of antioxidant capacity of Psidium guajava L. Decreasing IL-6 and increasing TAC were seen in the guajava hydroalcoholic extract and phenytoin groups. The difference of IL-6 between the wound treated guajava group and the wounded group was significant. The wound treated guajava group and wound treated phenytoin group on the 14^th day increased the number of fibroblast cells and volume density of sub-mucosae effectively to the same thickness to be considered as a healed sub-mucosae layer. The volume density of the epithelium changes showed statistically significant different responses based on gender.

CONCLUSION: In conclusion, hydroalcoholic extract of Psidium guajava L leaves might exert theraputic effects on oral mucositis.

PMID:35906612 | DOI:10.1186/s12906-022-03655-5

Implement Sci. 2022 Jul 29;17(1):51. doi: 10.1186/s13012-022-01218-3.

ABSTRACT

BACKGROUND: Interventions are often adapted; some adaptations may provoke more favorable outcomes, whereas some may not. A better understanding of the adaptations and their intended goals may elucidate which adaptations produce better outcomes. Improved methods are needed to better capture and characterize the impact of intervention adaptations.

METHODS: We used multiple data collection and analytic methods to characterize adaptations made by practices participating in a hybrid effectiveness-implementation study of a complex, multicomponent diabetes intervention. Data collection methods to identify adaptations included interviews, observations, and facilitator sessions resulting in transcripts, templated notes, and field notes. Adaptations gleaned from these sources were reduced and combined; then, their components were cataloged according to the framework for reporting adaptations and modifications to evidence-based interventions (FRAME). Analytic methods to characterize adaptations included a co-occurrence table, statistically based k-means clustering, and a taxonomic analysis.

RESULTS: We found that (1) different data collection methods elicited more overall adaptations, (2) multiple data collection methods provided understanding of the components of and reasons for adaptation, and (3) analytic methods revealed ways that adaptation components cluster together in unique patterns producing adaptation “types.” These types may be useful for understanding how the “who, what, how, and why” of adaptations may fit together and for analyzing with outcome data to determine if the adaptations produce more favorable outcomes rather than by adaptation components individually.

CONCLUSION: Adaptations were prevalent and discoverable through different methods. Enhancing methods to describe adaptations may better illuminate what works in providing improved intervention fit within context.

TRIAL REGISTRATION: This trial is registered on clinicaltrials.gov under Trial number NCT03590041 , posted July 18, 2018.

PMID:35906602 | DOI:10.1186/s13012-022-01218-3

BMC Musculoskelet Disord. 2022 Jul 30;23(1):729. doi: 10.1186/s12891-022-05618-w.

ABSTRACT

BACKGROUND: Restriction in foot and ankle joint range of motion, such as an ankle equinus, has been associated with increased plantar pressure and its complications. However, previous research is limited by its scope of measures and study populations. The aim of this study was to investigate the relationship between foot and ankle joint range of motion on barefoot plantar pressures during walking in healthy older adults.

METHODS: This cross-sectional study recruited 49 older adults. Participants underwent measures of foot (first metatarsophalangeal dorsiflexion range of motion, and navicular drop and drift) and ankle joint range of motion, foot posture, body mass index, and plantar pressure during barefoot walking. Spearman Rank Order Correlations were used to explore the relationship between foot and ankle measures, body mass index, and plantar pressure, with significant correlations explored in a hierarchical regression analysis. A Mann-Whitney U test was performed to compare plantar pressure values between those with and without ankle equinus per region of the foot.

RESULTS: Mean (SD) age and BMI were 72.4 years (5.2) and 29.8 kg/m² (5.9) respectively. A total of 32 of the 49 participants (65%) identified as female sex. Mean (SD) ankle joint range of motion was 32.7 (6.4) degrees with 17/49 (34.7%) participants classified as having an ankle equinus (defined as < 30 degrees of ankle joint dorsiflexion range of motion). We found that an ankle equinus predicted a statistically significant amount of peak forefoot plantar pressure (p = 0.03). Participants with an ankle equinus displayed significantly higher forefoot peak pressure 677.8 kPa (589.9 to 810.4) compared to those with no equinus 565.58 kPa (447.3 to 651.2), p = 0.02. A statistically significant correlation was found between body mass index and midfoot peak pressure (p < 0.01) and pressure-time integral (p < 0.01). No other significant correlations were found.

CONCLUSION: Clinicians should consider screening for an ankle equinus and body mass index as a simple way to identify which healthy older adults may be at risk of pressure-related complications in the mid- and forefoot.

PMID:35906599 | DOI:10.1186/s12891-022-05618-w

BMC Health Serv Res. 2022 Jul 29;22(1):971. doi: 10.1186/s12913-022-08351-1.

ABSTRACT

BACKGROUND: Opioid substitution treatment (OST) populations are aging and have increased mortality and somatic morbidity compared to general populations internationally. While OST patients have poor self-rated physical health and unmet healthcare needs, documented healthcare utilization has been sparsely investigated. The aim of this study was to assess registered healthcare utilization for somatic conditions in a sample of Swedish OST patients, and compare healthcare utilization among OST patients with and without use of on-site primary healthcare (PHC).

METHODS: Patients in OST in Malmö, Sweden, were recruited for a survey study conducted in 2017-2018. Survey data were compared with comprehensive patient records from specialized and primary care during one year prior to study inclusion (total n = 190). All patient records were examined for healthcare utilization, source of healthcare (PHC, emergency care and secondary care), and documented diagnoses and symptoms. Factors associated with healthcare utilization were analyzed by using logistic regression analysis. Patients with and without on-site PHC were compared by using descriptive statistics and Chi-2 test.

RESULTS: A total of 88% of the sample had been in direct or indirect contact with somatic healthcare during one year (PHC 66%; emergency care 28%; secondary care 67%). The most prevalent somatic diagnoses were infectious diseases (39%) and symptom diagnoses (37%). Respiratory, dermatological and musculoskeletal diagnoses, and trauma/intoxication were documented in 21-26% of the sample, respectively. PHC utilization was associated with older age and being born in Sweden. Among patients with on-site PHC (n = 25), the number utilizing secondary care was 84%, and certain diagnostic codes were more frequent in this group.

CONCLUSION: OST patients are seemingly underserved as regards their physical health. Since increased OST access decreases opioid overdose fatalities, the life expectancy among OST patients is likely to increase and thereby also increases the risk of age-related conditions. Thus, easily accessible physical healthcare is of great importance in this group. On-site PHC might be a way to establish healthcare contact with OST patients, especially for non-acute conditions, although further research is needed.

PMID:35906595 | DOI:10.1186/s12913-022-08351-1

Cardiovasc Diabetol. 2022 Jul 29;21(1):142. doi: 10.1186/s12933-022-01576-8.

ABSTRACT

BACKGROUND: Premature coronary artery disease (PCAD) has become more common in recent years and is often associated with poor outcomes. Triglyceride-glucose (TyG) index is a simple and reliable surrogate for insulin resistance (IR) and is an independent predictor of cardiovascular prognosis. However, the prognostic value of the TyG index in patients with PCAD remains uncertain. Thus, this study aimed to investigate the prognostic value and predictive performance of the TyG index in patients with PCAD.

METHODS: A total of 526 young subjects (male < 45 years, female < 55 years) with angiographically proven CAD from January 2013 to December 2018 were included consecutively in this study. Their clinical and laboratory parameters were collected, and the TyG index was calculated as [Formula: see text]. The follow-up time after discharge was 40-112 months (median, 68 months; interquartile range, 49‒83 months). The primary endpoint was the occurrence of the major adverse cardiovascular events (MACE), defined as the composite of all-cause death, non-fatal myocardial infarction (MI), coronary artery revascularization, and non-fatal stroke.

RESULTS: The TyG index was significantly associated with traditional cardiovascular risk factors and the Gensini score (GS). Kaplan-Meier survival (MACE-free) curves by tertiles of the TyG index showed statistically significant differences (log-rank test, p = 0.001). In the fully adjusted Cox regression model, the Hazard ratio (95% CI) of MACE was 2.17 (1.15-4.06) in tertile 3 and 1.45 (1.11-1.91) for per SD increase in the TyG index. Time-dependent ROC analyses of the TyG for prediction of MACE showed the area under the curves (AUC) reached 0.631 at 3 years, 0.643 at 6 years, and 0.710 at 9 years. Furthermore, adding TyG index to existing risk prediction model could improve outcome prediction [C-statistic increased from 0.715 to 0.719, p = 0.007; continuous net reclassification improvement (NRI) = 0.101, p = 0.362; integrated discrimination improvement (IDI) = 0.011, p = 0.017].

CONCLUSION: The TyG index is an independent predictor of MACE in patients with PCAD, suggesting that the TyG index has important clinical implications for risk stratification and early intervention of PCAD.

PMID:35906587 | DOI:10.1186/s12933-022-01576-8

BMC Public Health. 2022 Jul 29;22(1):1445. doi: 10.1186/s12889-022-13852-z.

ABSTRACT

BACKGROUND: Internet search volume reflects the level of Internet users’ risk perception during public health events. The Internet search volume index model, an algorithm of concentration of Internet users, and statistical analysis of popular topics on Weibo are used to analyze the effects of time, space, and space-time interaction. We conducted in-depth research on the characteristics of the spatial and temporal distribution of Internet users’ risk perceptions of public health events and the associated influential factors.

METHODS: We analyzed the spatiotemporal distribution characteristics of Internet users’ risk perception after the Wuhan “city closing” order during the coronavirus disease 2019 (COVID-19) pandemic. We established five linear regression models according to different time periods and analyzed factors influencing Internet users’ risk perception by employing a Poisson and spatial distribution and topic modeling analysis.

RESULTS: Economy, education, health, and the degree of information disclosure affect Internet users’ risk perception significantly. Internet users’ risk perception conforms to the exponential distribution law in time and has periodic characteristics and stability trends. Additionally, Internet users’ average arrival rate dropped from week 1 to week 8 after the “city closing.” Internet users’ risk perception has a uniform distribution in space, economic and social development level distribution consistency, spatial agglomeration, and other characteristics. The results of the time-space interaction show that after 8 weeks of COVID-19, Internet search hot topics have become more stable, and Internet users’ information demand structure has become more rational.

CONCLUSIONS: The Internet search cycle of the COVID-19 event is synchronized with the evolution cycle of the epidemic. The physical risk of Internet users is at the top of the risk structure, focusing on the strong concern about the government’s ability to control COVID-19 and its future trend. The government should strengthen network management; seize the risk control focus of key time nodes, regional locations, and information content of online communication; actively adjust the information content supply; effectively control the rebound of Internet users’ risk perception; establish a data-driven, risk-aware intelligence system for internet users; and guide people to actively face and overcome the potential risks and threats of COVID-19.

PMID:35906584 | DOI:10.1186/s12889-022-13852-z

J Craniofac Surg. 2022 Jul 28. doi: 10.1097/SCS.0000000000008753. Online ahead of print.

ABSTRACT

BACKGROUND: “Double eyelid” blepharoplasty is one of the most common cosmetic operations among Asian populations. Some patients might present with concomitant mild to moderate blepharoptosis, even though they choose initially to undergo blepharoplasty for cosmetic reasons.

OBJECTIVE: Using nonincisional double eyelid surgery without ptosis correction tends to produce unsatisfactory results. We introduce our modified suture method for the simultaneous correction of blepharoptosis during double eyelid blepharoplasty.

MATERIALS AND METHODS: We carried out a retrospective review on 13 patients who underwent simultaneous nonincisional ptosis correction and double eyelid surgery, using a single-knot continuous technique, from January 2017 to December 2019. A superior tarsal (Müller’s) muscle tagging suture was utilized to achieve an accurate tucking during surgery and create a double upper lid fold simultaneously.

RESULTS: The mean patient age was 31.8 years (range=23-54), and 9 patients (69%) were female. The mean marginal reflex distance 1 increased from 2.46±0.36 mm preoperatively to 4.07±0.61 mm postoperatively with a statistically significant difference. Most patients showed favorable results with an average of 10.8 months of follow-up and minimal complications.

CONCLUSIONS: This simultaneous double eyelid blepharoplasty technique using a single-knot, continuous, nonincisional technique is relatively easy and effective, with minimal downtime and few postoperative complications, and avoids scarring for patients with mild to moderate blepharoptosis.

PMID:35905501 | DOI:10.1097/SCS.0000000000008753

Can Urol Assoc J. 2022 Aug;16(8):273-278. doi: 10.5489/cuaj.7974.

ABSTRACT

INTRODUCTION: The COVID-19 pandemic has caused many residency programs to pivot from traditional face-to-face to virtual teaching. The objective of this study was to assess the state of virtual education in Canadian urology programs and gauge interest in a national virtual curriculum.

METHODS: An electronic 15-item survey was distributed to all 13 Canadian urology programs’ directors and administrative assistants for circulation to residents. Data collection took place over six weeks from September to November 2020. A mixed-methods approach was used, including descriptive statistics and an inductive thematic analysis of responses to open-ended questions.

RESULTS: Eleven program directors and 32 residents from all four geographic areas (Atlantic, Ontario, Quebec, Western [MB, AB, BC]) responded to the survey. Overall, 95.3% of respondents indicated a role for virtual education in their program during the pandemic. Most respondents (74.4%) believe there is a significant or very significant role for a virtual national urology curriculum. All program directors indicated they are at least somewhat likely to require resident participation in such a curriculum. Most (90.6%) resident respondents indicated they believe such a curriculum will be at least somewhat important to their learning. Commonly described benefits include exposure to subspecialties, expertise at other institutions, and standardization of teaching. Commonly described barriers include difficulty with engagement, time zone differences, and lack of dedicated time for attendance.

CONCLUSIONS: During the COVID-19 pandemic, virtual education has become well-integrated in Canadian urology programs. This study highlights interest in the development of a national virtual urology curriculum and puts forth some key considerations to ensure its success.

PMID:35905483 | DOI:10.5489/cuaj.7974

J Clin Rheumatol. 2022 Jul 29. doi: 10.1097/RHU.0000000000001884. Online ahead of print.

ABSTRACT

OBJECTIVE: Cardiovascular disease is a major cause of morbidity and mortality in systemic lupus erythematosus (SLE). Hypertension (HTN) and nondipping are modifiable risk factors for cardiovascular disease. Limited studies are available for childhood-onset SLE (cSLE). We aimed to assess ambulatory blood pressure monitoring (ABPM) pattern in cSLE patients with normal office blood pressure.

METHODS: This cross-sectional single-center study enrolled 25 patients with cSLE, normal office blood pressure and normal renal function. We performed 24-hour ABPM and echocardiography to assess end-organ damage. Descriptive statistics were obtained, and comparison of variables using Fisher exact test, t test, and Mann-Whitney U test was performed to identify potential risk factors for nondipping.

RESULTS: Of the 25 patients, 22 were women; the median age was 18 years (interquartile range, 16-20 years). Median SLE duration was 4.2 years (interquartile range, 2.9-8.1 years); 18 patients had a history of lupus nephritis (LN). Four patients, 3 of whom had LN, had masked HTN. Fourteen patients (56%) were nondipping. The majority of patients without LN (71%) had a nondipping profile. Echocardiography was done for 15 patients. Left ventricular mass index, relative wall thickness, and ejection fraction were normal in all patients. Ambulatory blood pressure monitoring results led to changes in therapy in 5 patients.

CONCLUSION: Our data provide evidence of high prevalence of nondipping and masked HTN in patients with cSLE, even in patients without LN. Identifying ABPM abnormalities in these patients could potentially improve outcomes.

PMID:35905479 | DOI:10.1097/RHU.0000000000001884