Category: Statistics

Clin Implant Dent Relat Res. 2022 Jan 12. doi: 10.1111/cid.13064. Online ahead of print.

ABSTRACT

BACKGROUND: There have been several reports about the prognosis of teeth adjacent to edentulous spaces for implant-supported fixed prostheses (ISFPs) and removable partial dentures (RPDs). However, there are few reports about the prognosis of the other remaining teeth comparing ISFPs with RPDs.

PURPOSE: The aim of this study was to evaluate and compare the prognosis of the remaining teeth for ISFPs and RPDs in terms of survival and complication-free rates.

METHODS: Subjects were partially edentulous patients with ISFPs or RPDs inserted in 2003-2016. Teeth adjacent to edentulous spaces (A-teeth), teeth not adjacent to edentulous spaces (R-teeth), and teeth opposing edentulous spaces (O-teeth) were investigated. The endpoints were tooth extraction and complications. A multivariate cox regression model was used to estimate the risk factors for survival of the investigated teeth.

RESULTS: A total of 233 (ISFP: 89, RPD: 144) patients were included in the statistical analyses. An IFSP prosthesis, when compared to an RPD prosthesis did not significantly decrease the tooth loss rate for A-teeth (hazard ratio [HR]: 0.76; 95% confidence interval [CI]: 0.30-1.92), for R-teeth (HR: 0.54; 95% CI: 0.28-1.05), or for O-teeth (HR: 0.45; 95% CI: 0.10-2.09).

CONCLUSIONS: In partially edentulous spaces, the difference between ISFPs and RPDs does not affect the prognosis of teeth adjacent to edentulous spaces, teeth not adjacent to edentulous spaces, and teeth opposing edentulous spaces. Namely, our findings suggest that it depends largely on the tooth type, jaw, endodontic therapy performed, not on the type of prostheses.

PMID:35019228 | DOI:10.1111/cid.13064

Clin Implant Dent Relat Res. 2022 Jan 12. doi: 10.1111/cid.13061. Online ahead of print.

ABSTRACT

BACKGROUND: Short implants (up to 5-mm long) have shown good results when compared to longer implants placed in augmented bone.

PURPOSE: To evaluate if 4-mm ultrashort implants could also be an alternative to bone augmentation in the severely atrophic posterior jaws. The primary aim of the study was to compare implant survival rates between study groups.

MATERIALS AND METHODS: Eighty partially edentulous patients with posterior atrophic jaws (5-6 mm of bone above the mandibular canal and 4-5 mm below the maxillary sinus) were included: 40 patients in the maxilla and 40 in mandible. The patients were randomized to receive one to three 4-mm ultrashort implants or one to three implants at least 10-mm long in augmented bone. Results are reported 5 years after loading with the following outcome measures: implant and prosthetic failures, complications and peri-implant marginal bone level changes.

RESULTS: Thirty-two complications were reported for the control group in 18 patients versus 13 complications in 10 patients in the test group, the difference being not statistically significant (p = 0.103). In the augmented group, 12 implants failed in 6 patients versus 7 short implants in 6 cases, and 9 prostheses failed in the control group while 4 in the test one, without statistically significant differences (p = 1.000 and 0.363, respectively). At 5 years after loading, short implants lost on average 0.58 ± 0.40 mm of peri-implant marginal bone and long implants 0.99 ± 0.58 mm, the difference was statistically significant (p = 0.006).

CONCLUSION: Four-millimeter ultrashort implants showed similar if not better results when compared to longer implants placed in augmented jaws 5 years after loading. For this reason, their use could be in specific cases preferable to bone augmentation since the treatment is less invasive, faster, cheaper and associated with less morbidity. However, longer follow-ups and larger trials are needed.

PMID:35019219 | DOI:10.1111/cid.13061

Int J Rheum Dis. 2022 Jan 12. doi: 10.1111/1756-185X.14283. Online ahead of print.

ABSTRACT

AIM: The aim of this study is to evaluate the association between Klebsiella pneumoniae infection and ankylosing spondylitis (AS).

METHOD: Five electronic databases, PubMed, Embase, Medline, Web of Science, and Scopes, were searched until September 29, 2021. Cohort and case-control studies that assessed the association between K. pneumoniae infection and AS were included. Pooled odds ratio (OR) was selected to show the effect size. Subgroup analysis (active or inactive AS) and 2 forms of sensitivity analysis were conducted. All statistical analyses were conducted by using STATA 12.0.

RESULTS: There were 25 case-control studies finally included, including 8 studies concerning presence of K. pneumoniae in feces, and 17 studies concerning serum antibody (immunoglobulin [Ig]G, IgM, IgA) against K. pneumoniae. The results suggested that when compared with healthy people, presence of K. pneumoniae in feces was associated with AS (OR: 5.65; 95% CI: 1.68-19.00). Similarly, when compared with healthy people, higher positive rates of IgA (OR: 6.28; 95% CI: 3.32-11.91) and IgG (OR: 5.22; 95% CI: 1.36-19.99) were observed. Subgroup analyses suggested that association between K. pneumoniae and AS appears stronger in active AS.

CONCLUSION: When compared with healthy people, a significantly higher positive rate of K. pneumoniae in feces, serum IgA and IgG were observed in patients with AS, suggesting that K. pneumoniae probably plays a crucial role in the occurrence of AS. The findings in this study need further prospective investigations for confirmation.

PMID:35019225 | DOI:10.1111/1756-185X.14283

Clin Implant Dent Relat Res. 2022 Jan 12. doi: 10.1111/cid.13065. Online ahead of print.

ABSTRACT

BACKGROUND: Industry support is a significant funding source in implant dentistry research, not only to provide regulatory processes, but also to validate and promote products through randomized clinical trials (RCTs). However, industry funding should not affect scientific outcomes.

PURPOSE: The aim of this study was to investigate whether there is an association between industry support for RCTs in implant dentistry and a greater chance of the reporting of positive outcomes, and whether there are other funding tendencies.

MATERIALS AND METHODS: Randomized clinical trials from five implant dentistry journals were reviewed. Data were extracted, and descriptive and inferential statistical analyses (α = 0.05), including bivariate and multivariable logistic regression, and Spearman’s correlation were performed.

RESULTS: Two hundred eleven RCTs were included. Industry-funded and -unfunded studies presented similar outcomes, in terms of positive and negative results (p ≥ 0.05). North American and European countries received more industry funding, as did high-income countries, which showed well-established collaboration with each other. Clinical Oral Implants Research and Clinical Implant Dentistry and Related Research published 83.6% of industry-funded articles. Industry-funded studies from middle-income countries established more international collaborations with high-income countries than did unfunded studies. Citation numbers were similar for funded and unfunded studies. The chance of RCTs being industry-funded was higher for high-income (odds ratio [OR] = 3.00; 95% confidence interval [CI], 0.99-9.32; p = 0.05) and North American articles (OR = 3.40; 95% CI, 1.37-8.42; p = 0.008) than in lower-middle-income and other continents, respectively. Higher industry funding was associated with specific topics such as “surgical procedures,” “prosthodontics topics,” and “implant macrodesign” (OR = 4.7; 95% CI, 1.45-15.20; p = 0.010) and with the increase in numbers of institutions (OR = 1.52; 95% CI, 1.16-2.0; p = 0.002).

CONCLUSION: The available evidence suggests no association between industry funding and greater chances of the reporting of positive outcomes in implant dentistry RCTs. A strong association was identified in industry trends concerning geographic origins, higher numbers of institutions, and specific research topics.

PMID:35019213 | DOI:10.1111/cid.13065

J Magn Reson Imaging. 2022 Jan 12. doi: 10.1002/jmri.28063. Online ahead of print.

ABSTRACT

BACKGROUND: Intramyocardial hemorrhage (IMH) following ST-elevation myocardial infarction (STEMI) is associated with poor prognosis. In cardiac magnetic resonance (MR), T2* mapping is the reference standard for detecting IMH while cardiac diffusion tensor imaging (cDTI) can characterize myocardial architecture via fractional anisotropy (FA) and mean diffusivity (MD) of water molecules. The value of cDTI in the detection of IMH is not currently known.

HYPOTHESIS: cDTI can detect IMH post-STEMI.

STUDY TYPE: Prospective.

SUBJECTS: A total of 50 patients (20% female) scanned at 1-week (V1) and 3-month (V2) post-STEMI.

FIELD STRENGTH/SEQUENCE: A 3.0 T; inversion-recovery T1-weighted-imaging, multigradient-echo T2* mapping, spin-echo cDTI.

ASSESSMENT: T2* maps were analyzed to detect IMH (defined as areas with T2* < 20 msec within areas of infarction). cDTI images were co-registered to produce averaged diffusion-weighted-images (DWIs), MD, and FA maps; hypointense areas were manually planimetered for IMH quantification.

STATISTICS: On averaged DWI, the presence of hypointense signal in areas matching IMH on T2* maps constituted to true-positive detection of iron. Independent samples t-tests were used to compare regional cDTI values. Results were considered statistically significant at P ≤ 0.05.

RESULTS: At V1, 24 patients had IMH on T2*. On averaged DWI, all 24 patients had hypointense signal in matching areas. IMH size derived using averaged-DWI was nonsignificantly greater than from T2* (2.0 ± 1.0 cm² vs 1.89 ± 0.96 cm² , P = 0.69). Compared to surrounding infarcted myocardium, MD was significantly reduced (1.29 ± 0.20 × 10^-3 mm² /sec vs 1.75 ± 0.16 × 10^-3 mm² /sec) and FA was significantly increased (0.40 ± 0.07 vs 0.23 ± 0.03) within areas of IMH. By V2, all 24 patients with acute IMH continued to have hypointense signals on averaged-DWI in the affected area. T2* detected IMH in 96% of these patients. Overall, averaged-DWI had 100% sensitivity and 96% specificity for the detection of IMH.

DATA CONCLUSION: This study demonstrates that the parameters MD and FA are susceptible to the paramagnetic properties of iron, enabling cDTI to detect IMH.

EVIDENCE LEVEL: 1 TECHNICAL EFFICACY: Stage 2.

PMID:35019174 | DOI:10.1002/jmri.28063

Clin Cardiol. 2022 Jan 12. doi: 10.1002/clc.23765. Online ahead of print.

ABSTRACT

BACKGROUND: The use of antiarrhythmic drugs (AADs) in patients with chronic kidney disease (CKD) is complex because impaired renal clearance can cause increased drug levels, and risk of intolerance or adverse events. Due to the propensity for CKD to occur alongside atrial fibrillation/atrial flutter (AF/AFL), it is essential that AAD safety and efficacy are assessed for patients with CKD.

HYPOTHESIS: Dronedarone, an approved AAD, may present a suitable therapeutic option for patients with AF/AFL and concomitant CKD.

METHODS: EURIDIS-ADONIS (EURIDIS, NCT00259428; ADONIS, NCT00259376) were identically designed, multicenter, double-blind, parallel-group trials investigating AF/AFL control with dronedarone 400 mg twice daily versus placebo (randomized 2:1). In this post hoc analysis, the primary endpoint was time to first AF/AFL. Patients were stratified according to renal function using the CKD-Epidemiology Collaboration equation and divided into estimated glomerular filtration rate (eGFR) subgroups of 30-44, 45-59, 60-89, and ≥90 ml/min. Time-to-events between treatment groups were compared using log-rank testing and Cox regression.

RESULTS: At baseline, most (86%) patients demonstrated a mild or mild-to-moderate eGFR decrease. Median time to first AF/AFL recurrence was significantly longer with dronedarone versus placebo for all eGFR subgroups except the 30 to 44 ml/min group, where the trend was similar but statistical power may have been limited by the small population. eGFR stratification had no significant effect on serious adverse events, deaths, or treatment discontinuations.

CONCLUSIONS: This analysis suggests that dronedarone could be an effective therapeutic option for AF with an acceptable safety profile in patients with impaired renal function.

PMID:35019175 | DOI:10.1002/clc.23765

Neurourol Urodyn. 2022 Jan 12. doi: 10.1002/nau.24873. Online ahead of print.

ABSTRACT

PURPOSE: The aim of this study was to demonstrate features predictive of treatment response for patient-tailored overactive bladder (OAB) intervention with an implantable tibial neurostimulator using patient and technical prediction factors.

MATERIALS AND METHODS: This study was designed as a follow-up study based on parameter settings and patients’ preferences during the pilot and extended study of the implantable tibial nerve stimulator (RENOVA™ iStim system). For this study, we compared all treatment parameters (stimulation amplitude, frequency, and pulse width) and usage data (duration of treatment) during the different follow-up visits.

RESULTS: We obtained usage data from a total of 32 patients who were implanted with the system between February and September 2015. Age, sex, body mass index (BMI) and previous experience with percutaneous tibial nerve stimulation (PTNS) treatment were considered as possible prediction factors for treatment success. However, only BMI was considered a statistically significant prediction factor (p = 0.042). A statistically significant increase in mean treatment level was seen in the responder group during the 3 month follow-up visit (mean: 6.7 mA, SD 0.416) as compared with the initial system activation visit (mean: 5.8 mA, SD 0.400) (p = 0.049). No other visits demonstrated statistically significant changes in both groups (responders and nonresponders) during the defined timepoints.

CONCLUSION: This data underscores the need to use patient-tailored OAB treatment. BMI was found to be a negative predictive factor for treatment success. However, it was not possible to develop a specific responder model. A model predicting response to treatment could be useful for implementing shared decision making.

PMID:35019163 | DOI:10.1002/nau.24873

Aesthet Surg J. 2021 Nov 20:sjab398. doi: 10.1093/asj/sjab398. Online ahead of print.

ABSTRACT

BACKGROUND: Although there is an abundance of literature on nonablative laser and energy-based therapies for the management of skin conditions, adverse events are inconsistently addressed and range widely across studies. Fitzpatrick skin phototypes (SPTs) IV to VI are believed to be at higher risk.

OBJECTIVES: The aim of this study was to determine the types and rates of adverse events in nonablative laser and energy-based therapies among patients with SPTs IV to VI.

METHODS: Articles addressing nonablative laser and energy-based therapies for skin rejuvenation and acne scarring in patients with SPTs IV to VI that provided data on adverse events were included. The pooled prevalence of each adverse event was calculated. To determine whether age, treatment indication, SPT, and device type influenced incidence, subgroup and meta-regression analyses were performed. Heterogeneity was evaluated with the I2 statistic.

RESULTS: Forty-three studies were included in the meta-analysis. The sample size was 1654, and the median age of subjects was 39.4 years. The most common adverse events were postinflammatory hyperpigmentation (PIH) (rate, 8.1%) and prolonged erythema (rate, 0.6%). The rate of PIH was significantly higher for diode and erbium-doped lasers compared with intense pulsed light and radiofrequency. PIH correlated positively with SPT, laser density, and total energy delivered.

CONCLUSIONS: Although the overall rate of adverse events in nonablative laser and energy-based therapies for SPTs IV to VI is low, the incidence of PIH is not insignificant. Certain lasers, such as diode, Q-switched Nd:YAG, and erbium-doped lasers, tend to have higher rates of PIH, whereas intense pulsed light and radiofrequency have minimal risk. Higher SPTs and higher energy deliverance correlate positively with the incidence of PIH.

PMID:35019139 | DOI:10.1093/asj/sjab398

Clin Cardiol. 2022 Jan 12. doi: 10.1002/clc.23773. Online ahead of print.

ABSTRACT

BACKGROUND: Despite low-density lipoprotein cholesterol-lowering therapies and other standard-of-care therapy, there remains a substantial residual atherosclerotic risk among patients with an acute coronary syndrome (ACS). This study aims to estimate the risk of early and late recurrent major adverse cardiovascular events (MACE) and address its implications on trial design.

METHODS: A literature search was performed to collect phase III interventional trials on high-risk ACS patients. Pooled event rates at 90 and 360 days were estimated by fitting random-effects models using the DerSimonian-Laird method. Under the assumption of a total sample size of 10,000 and 1:1 allocation at a one-sided alpha of 0.025 using the log-rank test, the relationship between power and relative risk reduction (RRR) or absolute risk reduction (ARR) was explored for early versus late MACE endpoint.

RESULTS: Seven trials representing 82,727 recent ACS patients were analyzed. The pooled rates of recurrent MACE were 4.1% and 8.3% at 90 and 360 days. Approximately 49% of events occurred within the first 90 days. Based on the estimated risks at 90 and 360 days, to attain 90% statistical power, a lower magnitude of RRR is required for late MACE than early MACE (22% vs. 30%), whereas a lower magnitude of ARR is required for early MACE than late MACE (1.2% vs. 1.8%).

CONCLUSION: The initial 90-day window after ACS represents a vulnerable period for recurrent events. From a trial design perspective, determining a clinically important benefit by RRR versus ARR may influence the decision between early and late MACE as the study endpoint.

PMID:35019162 | DOI:10.1002/clc.23773

Arq Bras Cir Dig. 2022 Jan 5;34(3):e1622. doi: 10.1590/0102-672020210002e1622. eCollection 2022.

ABSTRACT

BACKGROUND: The incidence of abdominal hernia in cirrhotic patients is as higher as 20%; in cases of major ascites the incidence may increase up to 40%. One of the main and most serious complications in cirrhotic postoperative period (PO) is acute kidney injury (AKI).

AIM: To analyze the renal function of cirrhotic patients undergoing to hernia surgery and evaluate the factors related to AKI.

METHODS: Follow-up of 174 cirrhotic patients who underwent hernia surgery. Laboratory tests including the renal function were collected in the PO.AKI was defined based on the consensus of the ascite´s club. They were divided into two groups: with (AKI PO) and without AKI .

RESULTS: All 174 patients were enrolled and AKI occurred in 58 (34.9%). In the AKI PO group, 74.1% had emergency surgery, whereas in the group without AKI PO it was only 34.6%.In the group with AKI PO, 90.4% presented complications, whereas in the group without AKI PO they occurred only in 29.9%. Variables age, baseline MELD, baseline creatinine, creatinine in immediate postoperative (POI), AKI and the presence of ascites were statistically significant for survival.

CONCLUSIONS: There is association between AKI PO and emergency surgery and, also, between AKI PO and complications after surgery. The factors related to higher occurrence were initial MELD, basal Cr, Cr POI. The patients with postoperative AKI had a higher rate of complications and higher mortality.

PMID:35019134 | DOI:10.1590/0102-672020210002e1622