Tag: statistics

Aliment Pharmacol Ther. 2021 Jul 12. doi: 10.1111/apt.16464. Online ahead of print.

ABSTRACT

BACKGROUND: In 2019, the United States Food and Drug Administration detected above-regulation levels of the human carcinogen N-nitrosodimethylamine (NDMA) in ranitidine, resulting in a complete removal of the medication from the market. NDMA is known to cause gastrointestinal malignancies in animal models.

AIM: To determine if patients who were receiving ranitidine have a higher risk of developing cancers of the digestive tract compared to patients taking other anti-reflux medications.

METHODS: Using the nationwide database IBM Explorys, patients taking ranitidine were compared to patients on either famotidine or omeprazole. Incidence data of new malignancies of the oesophagus, stomach, liver, pancreas, and colon/rectum were obtained in 1-year intervals for up to 10 years. Two multivariable logistic regression models were used to calculate odds ratios (ORs), one adjusting for common risk factors for each cancer studied, and the other for demographic factors.

RESULTS: Patients on ranitidine who were compared to patients on famotidine had ORs of 0.51(95% CI 0.43-0.60), 0.43(95% CI 0.36-0.51), 0.39(95% CI 0.36-0.41), 0.54(95% CI 0.49-0.62), and 0.46(95% CI 0.43-0.49) of developing oesophageal, gastric, hepatocellular, pancreatic, and colorectal cancers, respectively (P < 0.001). Patients on ranitidine compared to omeprazole had ORs of 0.62(95% CI 0.52-0.72), 0.58(95% CI 0.49-0.68), 0.81 (95% CI 0.76-0.86), 0.68(95% CI 0.60-0.76), and 0.66(95% CI 0.62-0.70) of developing oesophageal, gastric, hepatocellular, pancreatic, and colorectal cancers respectively (P < 0.001).

CONCLUSIONS: Use of ranitidine was not associated with an increased odds of developing gastrointestinal malignancies compared to omeprazole or famotidine use.

PMID:34251045 | DOI:10.1111/apt.16464

Stat Med. 2021 Jul 30;40(17):3889-3891. doi: 10.1002/sim.9078.

NO ABSTRACT

PMID:34251035 | DOI:10.1002/sim.9078

Stat Med. 2021 Jul 30;40(17):3892-3894. doi: 10.1002/sim.9033.

NO ABSTRACT

PMID:34251036 | DOI:10.1002/sim.9033

Stat Med. 2021 Jul 30;40(17):3887-3888. doi: 10.1002/sim.8989.

NO ABSTRACT

PMID:34251037 | DOI:10.1002/sim.8989

J Back Musculoskelet Rehabil. 2021 Jul 2. doi: 10.3233/BMR-200251. Online ahead of print.

ABSTRACT

BACKGROUND: Prone hip extension (PHE) has been investigated to strengthen the hip joint and back extensor muscles. However, it has not been compared with various PHE exercises in individuals with iliopsoas shortness.

OBJECTIVE: This study compared pelvic compensation and hip and back extensor muscle activities in individuals with iliopsoas shortness during prone hip extension (PHE) using the abdominal drawing-in maneuver alone (PHEA) and after iliopsoas stretching (PHEAS).

METHODS: Twenty-five individuals with iliopsoas shortness were included in the study. Electromyography was used to investigate bilateral erector spinae (ES) and ipsilateral gluteus maximus (GM), biceps femoris (BF), and semitendinosus (ST) muscles during PHE, PHEA, and PHEAS. Pelvic anterior tilting and rotation angles were measured during each PHE exercise via electromagnetic motion tracking. A modified Thomas test was used to examine the hip extension angle before and after iliopsoas stretching. One-way repeated-measures analysis of variance was used to investigate differences in pelvic anterior tilting and rotation angle and in hip and back extensor muscle activities among PHE, PHEA, and PHEAS. The level of statistical significance was set at α= 0.01.

RESULTS: GM muscle activity was significantly greater with PHEAS, compared to PHE and PHEA (p< 0.01). Bilateral ES and ipsilateral BF and ST muscle activities were significantly reduced with PHEAS, compared to PHE and PHEA (p< 0.01). Anterior pelvic tilting and rotation angles were significantly reduced with PHEAS, compared to PHE and PHEA (p< 0.01).

CONCLUSIONS: PHEAS is recommended to selectively strengthen GM muscles with minimal BF and ST muscle activities and pelvic compensation in individuals with iliopsoas shortness. The abdominal drawing-in maneuver (ADIM) after iliopsoas stretching is more efficient than ADIM alone during PHE, especially in individuals with iliopsoas shortness.

PMID:34250929 | DOI:10.3233/BMR-200251

Pediatr Infect Dis J. 2021 Aug 1;40(8):710-714. doi: 10.1097/INF.0000000000003144.

ABSTRACT

BACKGROUND: Resistant Kawasaki disease (KD) represents 10%-15% of KD patients and increases risk of coronary artery abnormalities (CAAs). Different scores exist to predict resistant KD but only in Japanese population, although a French team has recently proposed a new scoring system. The principal objective of this study is to establish criteria to predict resistant KD in our representative French population. The second objective is an attempt to develop a predictive score of resistant KD.

METHODS: We conducted a retrospective multicenter study including 2 universities and five secondary hospitals in Eastern France. Patients were included over a period from January 1, 2010 through December 31, 2019. Diagnosis of KD was recorded to the European Single Hub and Access point for pediatric Rheumatology in Europe (SHARE) initiative criteria.

RESULTS: Two hundred two eligible patients had KD and 194 patients were analyzed: 160 sensitive KD and 34 (17.5%) resistant KD. In univariate model, serum sodium <133 mmol/L (odds ratio [OR] 2.97 [1.40-6.45]), hemoglobin level <110 g/L (OR 3.17 [1.46-7.34]), neutrophils >80% (OR 2.36 [1.03-5.25]), C reactive protein level >150 mg/L (OR 4.47 [2.07-10.19]), CAA (OR 3.85 [1.67-8.79]) or myocarditis (OR 6.98 [1.47-36.95]) at the diagnosis were statistically significant, but only serum sodium was an independent factor of resistant KD.

CONCLUSION: This study shows an association between resistant KD and biologic and echocardiography criteria, but only serum sodium is an independent predictive factor. A score to predict resistant KD could not yet be established.

PMID:34250971 | DOI:10.1097/INF.0000000000003144

Technol Health Care. 2021 Jul 2. doi: 10.3233/THC-212974. Online ahead of print.

ABSTRACT

BACKGROUND: The use of 3D printed material in the dental field is gaining tremendous attention. However, studies related to 3D printed denture resins are scarce and need consideration before their inclusion in routine clinical practice.

OBJECTIVE: This study aimed to assess the surface roughness (Ra) of 3D printed denture resins following aging and mechanical brushing.

METHODS: Forty round samples (diameter, 10 mm and thickness, 3 mm) were fabricated from two 3D printed (DentaBASE and Denture 3D+) and one conventional polymethylmethacrylate (PMMA) denture materials. The samples were thermo-cycled, subjected to mechanical brushing, and later immersed in either artificial saliva (AS), coffee, cola, or lemon juice (n= 10) to simulate one and two years of oral use. Surface roughness (Ra) was determined using a non-contact profilometer and scanning electron microscope was used for qualitative analysis. The data was analyzed using SPSS v.20 (α= 0.05).

RESULTS: Denture 3D+ demonstrated highest mean Ra (1.15 ± 0.28 μm), followed by PMMA (0.99 ± 0.50 μm) and DentaBASE (0.81 ± 24). The difference in mean Ra between the materials was statistically non-significant (P= 0.08). Amongst the different beverages used, the highest Ra was observed for samples immersed in lemon juice (1.06 ± 0.40 μm) followed by cola (1.04 ± 0.46 μm) and coffee (0.98 ± 0.40 μm), respectively. The lowest Ra was observed for samples immersed in AS (0.85 ± 0.24 μm).

CONCLUSION: The surface roughness of 3D printed denture resins was comparable with that of conventional PMMA resins. Denture 3D+ demonstrated the highest mean roughness, followed by PMMA and DentaBASE.

PMID:34250915 | DOI:10.3233/THC-212974

Technol Health Care. 2021 Jul 2. doi: 10.3233/THC-213062. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: The aim of this study was to compare the efficacy of photobiomodulation therapy (PBMT) and photodynamic therapy (PDT) as adjuncts to mechanical debridement (MD) for the treatment of peri-implantitis. The present study is based on the null hypothesis that there is no difference in the peri-implant inflammatory parameters (modified plaque index [mPI], modified gingival index [mGI], probing depth [PD]) and crestal bone loss (CBL) following MD either with PBMT or PDT in patients with peri-implantitis.

METHODS: Forty-nine patients with peri-implantitis were randomly categorized into three groups. In Groups 1 and 2, patients underwent MD with adjunct PBMT and PDT, respectively. In Group 3, patients underwent MD alone (controls). Peri-implant inflammatory parameters were measured at baseline and 3-months follow-up. P-values < 0.01 were considered statistically significant.

RESULTS: At baseline, peri-implant clinicoradiographic parameters were comparable in all groups. Compared with baseline, there was a significant reduction in mPI (P< 0.001), mGI (P< 0.001) and PD (P< 0.001) in Groups 1 and 2 at 3-months follow-up. In Group 3, there was no difference in the scores of mPI, mGI and PD at follow-up. At 3-months follow-up, there was no difference in mPI, mGI and PD among patients in Groups 1 and 2. The mPI (P< 0.001), mGI (P< 0.001) and PD (P< 0.001) were significantly higher in Group 3 than Groups 1 and 2. The CBL was comparable in all groups at follow-up.

CONCLUSION: PBMT and PDT seem to be useful adjuncts to MD for the treatment of peri-implant soft-tissue inflammation among patients with peri-implantitis.

PMID:34250918 | DOI:10.3233/THC-213062

Cancer Med. 2021 Jul 11. doi: 10.1002/cam4.3870. Online ahead of print.

ABSTRACT

Recent studies defined a potentially important role of the microbiome in modulating pancreatic ductal adenocarcinoma (PDAC) and responses to therapies. We hypothesized that antibiotic usage may predict outcomes in patients with PDAC. We retrospectively analyzed clinical data of patients with resectable or metastatic PDAC seen at MD Anderson Cancer from 2003 to 2017. Demographic, chemotherapy regimen and antibiotic use, duration, type, and reason for indication were recorded. A total of 580 patients with PDAC were studied, 342 resected and 238 metastatic patients, selected retrospectively from our database. Antibiotic use, for longer than 48 hrs, was detected in 209 resected patients (61%) and 195 metastatic ones (62%). On resectable patients, we did not find differences in overall survival (OS) or progression-free survival (PFS), based on antibiotic intake. However, in the metastatic cohort, antibiotic consumption was associated with a significantly longer OS (13.3 months vs. 9.0 months, HR 0.48, 95% CI 0.34-0.7, p = 0.0001) and PFS (4.4 months vs. 2 months, HR 0.48, 95% CI 0.34-0.68, p = <0.0001). In multivariate analysis, the impact of ATB remained significant for PFS (HR 0.59, p = 0.005) and borderline statistically significant for OS (HR 0.69, p = 0.06). When we analyzed by chemotherapy regimen, we found that patients who received gemcitabine-based chemotherapy as first-line therapy (n = 118) had significantly prolonged OS (HR 0.4, p 0.0013) and PFS (HR 0.55, p 0.02) if they received antibiotics, while those receiving 5FU-based chemotherapy (n = 98) had only prolonged PFS (HR 0.54, p = 0.03). Antibiotics-associated modulation of the microbiome is associated with better outcomes in patients with metastatic PDAC.

PMID:34250759 | DOI:10.1002/cam4.3870

Acad Emerg Med. 2021 Jul 12. doi: 10.1111/acem.14343. Online ahead of print.

ABSTRACT

BACKGROUND: Federal exception from informed consent (EFIC) procedures allow studies to enroll patients with time-sensitive, life-threatening conditions when written consent is not feasible. Our objective was to compare enrollment rates with and without EFIC in a trial of tranexamic acid (TXA) for children with hemorrhagic injuries.

METHODS: We conducted a four-center randomized controlled pilot and feasibility trial evaluating TXA in children with severe hemorrhagic brain and/or torso injuries. We initiated the trial enrolling patients without EFIC. After 3 months of enrollment, we met our a priori futility threshold and paused the trial to incorporate EFIC procedures and obtain regulatory approval. We then restarted the trial allowing EFIC if the guardian was unable to provide timely written consent. We used descriptive statistics to compare characteristics of eligible patients approached with and without EFIC procedures. We also calculated the time delay to restart the trial using EFIC.

RESULTS: We enrolled 1 of 15 (6.7%) eligible patients (0.17 per site per month) prior to using EFIC procedures. Of the 14 missed eligible patients, 7 (50%) were not enrolled because guardians were not present or were injured and unable to provide written consent. After obtaining approval for EFIC, we enrolled 30 of 48 (62.5%) eligible patients (1.34 per site per month). Of these 30 patients, 22 (73.3%) were enrolled with EFIC. Of the 22, no guardians refused written consent after randomization. There were no significant differences in the eligibility rate and patient characteristics enrolled with and without EFIC procedures. Across all sites, the mean delay to restart the trial using EFIC procedures was 12 months.

CONCLUSIONS: In a multicenter trial of severely injured children, the use of EFIC procedures greatly increased the enrollment rate and was well accepted by guardians. Initiating the trial without EFIC procedures led to a significant delay in enrollment.

PMID:34250690 | DOI:10.1111/acem.14343