Category: Statistics

Med Sci Sports Exerc. 2022 Jul 19. doi: 10.1249/MSS.0000000000003005. Online ahead of print.

ABSTRACT

PURPOSE: The objective of the present study was to evaluate the implementation of the program in real life and the evolution of the QoL in breast cancer patients after 3 months of supervised PA in real-life and to determine the factors associated with changes in various QoL dimensions.

METHODS: This prospective cohort study was carried out in female patients with breast cancer diagnosed within a maximum of 3 years. QoL and physical exertion intensity during the supervised PA sessions were assessed by the QLQ-C30 and Borg scale, respectively. Statistical analyzes comparing QoL scores between the start and the end of supervised PA program were assessed using paired Student’s t tests. Multivariate analysis was performed by linear regression with only variables with a p-value <0.15 in univariate model.

RESULTS: A total of 93 patients were included in the analyzes. There was a significant improvement of social functioning at T3 (∆ = 11.5; p < 0.001). The improvement of social functioning was significantly and independently associated to the BORG improvement (β = 2.66 ± 1.31, p = 0.046), chemotherapy (β = 11.03 ± 5.45, p = 0.046), hormone therapy (β = -13.91 ± 5.51, p = 0.013), social isolation (β = -14.81 ± 6.55, p = 0.026) and comorbidities (β = -15.32 ± 5.59, p = 0.007).

CONCLUSIONS: We observed a real enthusiasm and need among patients for practicing physical activity supervised by a sport trainer near their home. The increase in the intensity of exercise over time contributes to the improvement of the QoL, especially on the social functioning. These results, consistent with previous literature, reinforce the importance of exercise intensity on many dimensions of QoL. In addition, patients expressed great satisfaction with the supervised program, resulting in a strong desire to maintain long-term physical activity.

PMID:35881932 | DOI:10.1249/MSS.0000000000003005

Am J Health Syst Pharm. 2022 Jul 26:zxac190. doi: 10.1093/ajhp/zxac190. Online ahead of print.

ABSTRACT

DISCLAIMER: In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.

PURPOSE: Patients on hemodialysis have a high risk of medication-related problems. Studies using deprescribing algorithms to reduce the number of inappropriate medications in this population have been published, but none have used a patient-partnership approach. Our study evaluated the impact of a similar intervention with a patient-partnership approach.

METHODS: The objective was to describe the implementation of a pharmacist-led intervention with a patient-partnership approach using deprescribing algorithms and its impact on the reduction of inappropriate medications in patients on hemodialysis. Eight algorithms were developed by pharmacists and nephrologists to assess the appropriateness of medications. Pharmacists identified patients taking targeted medications. Following patient enrollment, pharmacists assessed medications with patients and applied the algorithms. With patient consent, deprescription was suggested to nephrologists if applicable. Specific data on each targeted medication were collected at 4 and 16 weeks. Descriptive statistics were used to examine the effects of the deprescribing intervention.

RESULTS: Of 270 patients, 256 were taking at least one targeted medication. Of the 122 patients taking at least one targeted medication who were approached to participate, 66 were included in the study. At enrollment, these patients were taking 252 targeted medications, of which 59 (23.4%) were determined to be inappropriate. Deprescription was initiated for 35 of these 59 medications (59.3%). At 4 weeks, 33 of the 59 medications (55.9%) were still deprescribed, while, at 16 weeks, 27 of the 59 medications (45.8%) were still deprescribed. Proton pump inhibitors and benzodiazepines or Z-drugs were the most common inappropriate medications, and allopurinol was the most deprescribed medication.

CONCLUSION: A pharmacist-led intervention with a patient-partnership approach and using deprescribing algorithms reduced the number of inappropriate medications in patients on hemodialysis.

PMID:35881917 | DOI:10.1093/ajhp/zxac190

J Cardiovasc Pharmacol. 2022 Jun 27. doi: 10.1097/FJC.0000000000001321. Online ahead of print.

ABSTRACT

Bradycardia and QTc interval prolongation on the ECG have been reported with remdesivir (Veklury®), an antiviral drug recently approved for treating severely ill COVID-19 patients. The objective was to evaluate the effects of remdesivir on cardiac electrophysiology ex vivo and in vivo. Ex vivo: Langendorff retroperfusion experiments were performed on isolated hearts from male Hartley guinea pigs (n=23, total) exposed to either remdesivir 3, 10 or 30 µmol/L to assess drug-induced prolongation of monophasic action potential duration measured at 90% repolarization (MAPD90). In vivo: ECG recordings using wireless cardiac telemetry were performed in guinea pigs (n=6) treated with daily i.p. doses of remdesivir 5 mg/kg on Day 1 and 2.5 mg/kg on Days 2-10. Ex vivo remdesivir (3, 10 and 30 µmol/L) had no statistically significant effect on MAPD90, while pacing the hearts at basic stimulation cycle lengths of 200 or 250 ms, or when the hearts were not paced and beating at their intrinsic heart rate. In a second set of similar ex vivo experiments, remdesivir 10 µmol/L did not potentiate the MAPD90-prolonging effects of dofetilide 20 nmol/L (n=4) hearts). In vivo remdesivir caused small but statistically significant prolongations of the RR and QTcF intervals at Day 1 (5 mg/kg) and at Day 10 (2.5 mg/kg). No ventricular arrhythmias were ever observed under the effect of remdesivir. Remdesivir causes bradycardia and mild QTc prolongation, which nonetheless, could be of clinical relevance in many hospitalized COVID-19 patients concomitantly treated with multiple drugs.

PMID:35881906 | DOI:10.1097/FJC.0000000000001321

J Cardiovasc Pharmacol. 2022 Jul 12. doi: 10.1097/FJC.0000000000001331. Online ahead of print.

ABSTRACT

BACKGROUND: Modulation of the inflammatory response is a promising therapeutic strategy in acute myocardial infarction. The novel approach is based upon the anti-inflammatory and cytoprotective properties mediated by the engagement of the Low-Density Lipoprotein Related Protein 1 (LRP1) receptor. SERPIN Peptide 16 (SP16) is a synthetic, selective LRP1 agonist. We herein present the results of a study with a single subcutaneous administration of SP16 in 10 patients with STEMI, to appraise its safety and tolerability and explore the effects on the acute inflammatory response, infarct size, and cardiac function.

METHODS: Ten patients with ST-segment elevation myocardial infarction (STEMI) were enrolled within 12 hours of symptoms onset and 6 hours of percutaneous coronary intervention (PCI) in a single-center, single-arm, open-label study of a single subcutaneous administration of SP16 (0.2 mg/kg). Serial clinical biomarkers and echocardiography data were collected up to 12 months. The data are presented separately for the treatment group and compared with historical controls from a placebo-treated arm in a recently completed clinical trial (N=28) with similar enrollment criteria.

RESULTS: All ten patients with STEMI received subcutaneous administration of SP16, 381 [272 to 478] minutes after PCI, without any treatment-related adverse events. The area under the curve (AUC) for C reactive protein (CRP) was 133 [46 to 528] mg•day/L in the SP16 treated group versus 286 [141 to 581] mg•day/L in the historical placebo-treated group (p=0.161). The AUC for creatine kinase-myocardial band (CK-MB) was 1,432 [675 to 3,089] ng•day/mL in the SP16-treated group versus 2,367 [830 to 4,750] ng•day/mL in the historical placebo-treated patients (p=0.428). Left ventricular ejection fraction (LVEF) was 46% [39 to 54] at baseline and 51% [46 to 58] at 1 year follow up in SP16 treated patients (interval change 5% [-0.3% to +9%] p=0.05) and 44% [38% to 56%] at baseline and 53% [43% to 59%] at 1 year follow up in historical placebo-treated patients (interval change 3% [-5% to 10%], p=0.305).

CONCLUSION: A single subcutaneous administration of SP16, a synthetic targeted LRP1 agonist, was safe and well tolerated in patients with STEMI. A trend toward reduction in the inflammatory response and infarct size with SP16 was noted; however, the sample size for this study was not based upon formal statistical criteria. More extensive studies are planned to determine the clinical efficacy of SP16 in STEMI.

PMID:35881895 | DOI:10.1097/FJC.0000000000001331

J Oral Implantol. 2022 Jul 26. doi: 10.1563/aaid-joi-D-21-00034. Online ahead of print.

ABSTRACT

The aim of this study was to evaluate primary stability of 3.7 mm diameter porous tantalum Trabecular MetalTM (TMTM) implant, and compare it to fully threaded implants, in the in vitro model of immediate implant placement in the anterior maxilla. A total of sixty implants were placed into bovine ribs using surgical guides. Implants were divided in three groups of twenty according to the design: TMTM, Tapered Screw-Vent® (TSV®) and NobelReplace®. To simulate immediate placement in anterior maxilla, implants were placed under a sharp angle towards the ribs, not fully submerged. Placement angle of 20.7 degrees was calculated after analysis of 148 virtually planned implants on CBCT scans of 40 patients. No statistically significant difference in implant stability quotient (ISQ) was found between TMTM (65.8 ± 2.6,), TSV® (64.7 ± 2.7) and NobelReplace® (64.6 ± 2.7). TSV® implants achieved higher insertion torque (37.0 ± 4.8 Ncm) than TMTM (32.9 ± 5.2 Ncm) and NobelReplace® (23.2 ± 3.3 Ncm). TSV® had shortest insertion time of 13.5 ± 1.0 seconds, compared to 15.2 ± 1.2 seconds for TMTM, and 19.7 ± 1.7 seconds for NobelReplace®. Pearson correlation analysis showed significantly correlated insertion torque and ISQ values for TMTM group (P=0.011, r=0.56), a non-significant correlation was found for TSV® and NobelReplace®. The results of the present study indicate that TMTM implant can achieve good primary implant stability in terms of insertion torque and resonance frequency analysis.

PMID:35881824 | DOI:10.1563/aaid-joi-D-21-00034

J Oral Implantol. 2022 Jul 26. doi: 10.1563/aaid-joi-D-21-00159. Online ahead of print.

ABSTRACT

Research regarding bone density assessment using cone beam computed tomography in low bone density regions is sparse. This in vitro study aimed to evaluate the predictability of cone beam computed tomography for low bone density regions and its correlations with primary implant stability when placing tapered design implants with a stepped osteotomy. Eighteen porcine mandibular condyles were used as simulated low bone density regions. Hounsfield units (HU), obtained via multislice computed tomography, and gray values (GV), obtained via cone beam computed tomography, were measured three times at one-month intervals. The maximum implant insertion torque (MIT) and implant stability quotient (ISQ) were recorded as the taper design implants were placed using a stepped osteotomy. HU and GV were measured as 335.05-803.07 and 389.98-906.40, respectively. For repeated measurements of HU and GV, the intraclass correlation coefficients were 0.989 and 0.980; the corresponding value for mean HU and GV was 0.768. Bland-Altman plots showed a mean difference between HU and GV of -78.15. Pearson correlation coefficients revealed a strong correlation between HU and GV (r=0.91, p<0.01). The mean ± standard deviation values for MIT and ISQ were 36.44 ± 6.64 Ncm and 80.85 ± 2.03, respectively, but no statistically significant correlations were found with GV and HU. Within the study’s limitations, GV showed similar bone density estimation compared to HU in soft bones. Tapered implant placement with a stepped osteotomy achieved stable primary implant stability in soft bones. However, these in vitro results need to be approved in further clinical studies.

PMID:35881816 | DOI:10.1563/aaid-joi-D-21-00159

J Oral Implantol. 2022 Jul 26. doi: 10.1563/aaid-joi-D-21-00186. Online ahead of print.

ABSTRACT

The role of systemic diseases in the development and progression of peri-implantitis remains unclear and requires discussion from various perspectives. This retrospective cohort study aimed to evaluate whether the types of systemic diseases affecting the time of onset of peri-implantitis. The cohort consisted of patients who underwent maintenance implant treatment between January 1998 and June 2020. Information on age, sex, history of periodontal disease, smoking habits, body mass index (BMI), systemic diseases, implant placement sites, and diagnosis of peri-implantitis were extracted. The relationships between the time of onset of peri-implantitis and the medical history of systemic diseases were determined statistically by applying the Kaplan-Meier analysis method and log-rank test. A total of 216 implants in 89 patients (34 male and 55 female) were included in this study. The average patient age was 53.9 ± 11.8 years at the first visit, and the mean duration of maintenance was 7 years and 4 months. A total of 43 patients had medical histories and were assigned to the systemic disease group. In this group, the overall prevalence of peri-implantitis was 25.4% (29 of 114 implants). The medical history of systemic diseases (odds ratio [OR] 6.87, 95% confidence interval [CI] 2.37-19.9) and dental history of periodontitis (OR 3.64, 95% CI 1.25-10.6) were assessed as risk factors for peri-implantitis. A significant difference in the time of onset of peri-implantitis was confirmed between patients with systemic disease and healthy patients. Dabetes mellitus, osteoporosis, and hypertension had a significant impact on the earlier onset of peri-implantitis.

PMID:35881819 | DOI:10.1563/aaid-joi-D-21-00186

J Oral Implantol. 2022 Jul 26. doi: 10.1563/aaid-joi-D-21-00310. Online ahead of print.

ABSTRACT

This systematic review aimed to evaluate computed tomographic scans for volumetric bone gain following lateral sinus floor augmentation of the atrophic posterior maxilla after the use of various bone-grafting materials using. The databases MEDLINE, EMBASE, CINAHL, Cochrane Central Registry of Controlled Trials (CENTRAL), and SCOPUS were used for a comprehensive search for all potentially eligible randomized controlled trials (RCTs), without language restrictions, from the beginning of each database until June 2021. The predictor variables for this review were autogenous bone (AB), allografts (AG), xenografts (XG), alloplastic bone (AP), which were assessed individually, and in combination with the inclusion of growth factors with XGs. The outcome variable was the graft volume on cone beam computed tomographic (CBCT) scans. Seven RCTs with a short-term observation period were included. Topographical analyses of all graft materials identified a volumetric reduction at 6 months post-grafting, compared to values immediately after graft placement. The volumetric reduction occurred regardless of the type of bone-grafting material. The largest volumetric gain over baseline, pre-graft values, was found with the AG+XG group. Autografts, the present gold standard bone-graft, showed a high resorption rate and inferior volumetric increase when compared to alternative grafting combinations. AG and XG also showed a significant difference with less volumetric gain than AP and their combinations. No difference was detected between AP and AG+AP. However, there was significantly less volumetric gain for AP alone compared AG+XG and XG-growth factors combinations. As a result, these findings suggest significant advantages to new bone formation using grafting materials in combination. To achieve a better understanding of topographical variables related to various grafting materials, more clinically focused RCTs, with sufficient statistical power to control for confounding factors, are needed.

PMID:35881815 | DOI:10.1563/aaid-joi-D-21-00310

Proc Natl Acad Sci U S A. 2022 Aug 2;119(31):e2203078119. doi: 10.1073/pnas.2203078119. Epub 2022 Jul 26.

ABSTRACT

The transcription-translation negative feedback loops underlying animal and fungal circadian clocks are remarkably similar in their molecular regulatory architecture and, although much is understood about their central mechanism, little is known about the spatiotemporal dynamics of the gene products involved. A common feature of these circadian oscillators is a significant temporal delay between rhythmic accumulation of clock messenger RNAs (mRNAs) encoding negative arm proteins, for example, frq in Neurospora and Per1-3 in mammals, and the appearance of the clock protein complexes assembled from the proteins they encode. Here, we report use of single-molecule RNA fluorescence in situ hybridization (smFISH) to show that the fraction of nuclei actively transcribing the clock gene frq changes in a circadian manner, and that these mRNAs cycle in abundance with fewer than five transcripts per nucleus at any time. Spatial point patterning statistics reveal that frq is spatially clustered near nuclei in a time of day-dependent manner and that clustering requires an RNA-binding protein, PRD-2 (PERIOD-2), recently shown also to bind to mRNA encoding another core clock component, casein kinase 1. An intrinsically disordered protein, PRD-2 displays behavior in vivo and in vitro consistent with participation in biomolecular condensates. These data are consistent with a role for phase-separating RNA-binding proteins in spatiotemporally organizing clock mRNAs to facilitate local translation and assembly of clock protein complexes.

PMID:35881801 | DOI:10.1073/pnas.2203078119

J Oral Implantol. 2022 Jul 26. doi: 10.1563/aaid-joi-D-21-00021. Online ahead of print.

ABSTRACT

This study was done to perform a systematic review and meta-analysis of the studies on the efficacy of acellular dermal matrix in increasing the Soft Tissue Thickness (STT) and Keratinized Mucosal Width (KMW) around dental implants. The PubMed, Scopus, Cochrane, Web of Science, and ProQuest databases were searched by July 2020 to retrieve relevant studies. Depending upon the heterogeneity of included studies, the Weighted Mean Difference (WMD) with 95% confidence interval was calculated using either fixed or random-effects model. Based on the meta-analysis of 6 studies, the effect of acellular dermal matrix on STT and KMW was significant (WMD: 1.07 (95%CI: 0.34, 1.79) P=0.004, and WMD: 1.99 (95%CI: 0.88, 3.09), P<0.001, respectively). Further, a comparison between the efficacy of the acellular dermal matrix and the control group, which included the autogenous soft tissue augmentation techniques, showed no statistically significant differences between groups (STT: WMD: 0.24 (95%CI: -0.26, 0.74) P=0.161 and KMW: WMD: -0.23 (95%CI: -0.68, 0.22), P=0.324). The subgroup analysis showed that simultaneous augmentation and implant placement were increased by 0.23 mm in the KMW, and the placement of acellular dermal matrix around loaded implants caused 0.5 mm decrease in the KMW, which was not statistically significant. Accordingly, it is possible to substitute acellular dermal matrix for soft tissue augmentation around dental implants..

PMID:35881814 | DOI:10.1563/aaid-joi-D-21-00021