Outcomes of Using Different Generations of Telescopic Intramedullary Nails in Lower Limbs in Management of Osteogenesis Imperfecta Patients. A Systematic Review

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Nabil AbdEl-Moneem Ghaly ◽  
Ahmed Rayan Ahmed ◽  
Tarik Abdelrahman Wafa
Keyword(s):  
Systematic Review ◽  
Osteogenesis Imperfecta ◽  
Statistical Significance ◽  
Lower Limbs ◽  
P Value ◽  
Type I ◽  
Complication Rates ◽  
Intramedullary Nails ◽  
Search Results ◽  
Cortical Perforation

Abstract Background Osteogenesis imperfecta is a group of heterogeneous disorders with a common characteristic of congenital bone fragility caused by mutations in genes encoding procollagen type I. (COL1A1 and COL1A2). Objectives This study aims to review the outcomes of the use of different generations of telescopic intramedullary nails in lower limbs for management of children with osteogenesis imperfecta (OI) and evaluate the functional outcomes of them. Patients and Methods Methodology: Criteria for considering studies for this review, types of studies: we will include: case series studies, retrospective cohort studies and we will exclude: case reports, cross sectional studies, non English studies. Search results will be conducted to systematic review management software and manually screened for eligibility to be included. PRISMA flowchart will be produced based on the search results and the inclusion/ exclusion criteria. Results One of the highest complications that have been very challenging for the orthopedic surgeons is migration and displacement of the telescopic intramedullary nails and FassierDuval nail has showed to have the lowest migration and displacement incidence rate (10.3%) which was clinically significant according to our statistics which supports the previous literature. On the other hand according to our statistics we found that there is no statistical significance in the cortical perforation of the telescopic nails between the different generations despite it might have been thought before that Bailey-Dubow nail has higher cortical perforation rate as the P value = 0.413. Post operative fractures and telescopic nail bending have shown no statistical significance according to our statistics which differ from each study when taken separately with P value = 0.252 and P value = 0.059 respectively. For the bending results we think that more studies are needed to increase the number of patients as it might show statistical significance according to its P value. Conclusion Fassier-Duval telescopic nail has good outcomes with the least complication rates and a promising generation of telescopic nail but needs a multicenter randomized control trials to conduct a level I evidence based on meta-analysis.

When Studies are in Error: Basic Statistical Vocabulary Needed to Understand Clinical Studies

1996 ◽  
Vol 1 (1) ◽  
pp. 25-28 ◽  
Author(s):  
Martin A. Weinstock
Keyword(s):  
Null Hypothesis ◽  
Statistical Power ◽  
Critical Appraisal ◽  
Type I Error ◽  
Statistical Significance ◽  
P Value ◽  
Type I ◽  
Type Ii ◽  
Type Ii Error ◽  
Error Type

Background: Accurate understanding of certain basic statistical terms and principles is key to critical appraisal of published literature. Objective: This review describes type I error, type II error, null hypothesis, p value, statistical significance, a, two-tailed and one-tailed tests, effect size, alternate hypothesis, statistical power, β, publication bias, confidence interval, standard error, and standard deviation, while including examples from reports of dermatologic studies. Conclusion: The application of the results of published studies to individual patients should be informed by an understanding of certain basic statistical concepts.

The Conundrum of P-Values: Statistical Significance is Unavoidable but Need Medical Significance Too

2020 ◽  
Author(s):  
Abhaya Indrayan
Keyword(s):  
Type I Error ◽  
Dominant Role ◽  
Statistical Significance ◽  
Empirical Studies ◽  
P Value ◽  
Selective Reporting ◽  
Type I ◽  
Practical Application ◽  
P Values ◽  
Zero Effect

Background: Small P-values have been conventionally considered as evidence to reject a null hypothesis in empirical studies. However, there is widespread criticism of P-values now and the threshold we use for statistical significance is questioned.Methods: This communication is on contrarian view and explains why P-value and its threshold are still useful for ruling out sampling fluctuation as a source of the findings.Results: The problem is not with P-values themselves but it is with their misuse, abuse, and over-use, including the dominant role they have assumed in empirical results. False results may be mostly because of errors in design, invalid data, inadequate analysis, inappropriate interpretation, accumulation of Type-I error, and selective reporting, and not because of P-values per se.Conclusion: A threshold of P-values such as 0.05 for statistical significance is helpful in making a binary inference for practical application of the result. However, a lower threshold can be suggested to reduce the chance of false results. Also, the emphasis should be on detecting a medically significant effect and not zero effect.

scholarly journals Risk factors for adverse clinical outcomes in patients with COVID-19: A systematic review and meta-analysis

2020 ◽  
Author(s):  
Vanesa Bellou ◽  
Ioanna Tzoulaki ◽  
Evangelos Evangelou ◽  
Lazaros Belbasis
Keyword(s):  
Risk Factors ◽  
Systematic Review ◽  
Clinical Outcomes ◽  
Randomized Clinical Trials ◽  
Clinical Decision Making ◽  
Statistical Significance ◽  
Specific Effect ◽  
Chronic Obstructive ◽  
P Value ◽  
Meta Analyses

Importance: COVID-19 is a clinically heterogeneous disease of varying severity and prognosis. Clinical characteristics that impact disease course could offer guidance for clinical decision making and future research endeavors and unveil disease pathways. Objective: To examine risk factors associated with adverse clinical outcomes in patients with COVID-19. Data sources: We performed a systematic review in PubMed from January 1 until April 19, 2020. Study selection: Observational studies that examined the association of any clinical characteristic with an adverse clinical outcome were considered eligible. We scrutinized studies for potential overlap. Data extraction and synthesis: Information on the effect of clinical factors on clinical endpoints of patients with COVID-19 was independently extracted by two researchers. When an effect size was not reported, crude odds ratios were calculated based on the available information from the eligible articles. Study-specific effect sizes from non-overlapping studies were synthesized applying the random-effects model. Main outcome and measure: The examined outcomes were severity and progression of disease, admission to ICU, need for mechanical ventilation, mortality, or a composite outcome. Results: We identified 88 eligible articles, and we performed a total of 256 meta-analyses on the association of 98 unique risk factors with five clinical outcomes. Seven meta-analyses presented the strongest epidemiological evidence in terms of statistical significance (P-value <0.005), between-study heterogeneity (I2 <50%), sample size (more than 1000 COVID-19 patients), 95% prediction interval excluded the null value, and absence of small-study effects. Elevated C-reactive protein (OR, 6.46; 95% CI, 4.85 - 8.60), decreased lymphocyte count (OR, 4.16; 95% CI, 3.17 - 5.45), cerebrovascular disease (OR, 2.84; 95% CI, 1.55 - 5.20), chronic obstructive pulmonary disease (OR, 4.44; 95% CI, 2.46 - 8.02), diabetes mellitus (OR, 2.04; 95% CI, 1.54 - 2.70), hemoptysis (OR, 7.03; 95% CI, 4.57 - 10.81), and male sex (OR, 1.51; 95% CI, 1.30 - 1.75) were associated with risk of severe COVID-19. Conclusions and relevance: Our results highlight factors that could be useful for prognostic model building, help guide patients' selection for randomized clinical trials, as well as provide alternative treatment targets by shedding light to disease pathophysiology.

The Fragility of Statistical Significance in Patellofemoral Instability Research: A Systematic Review

2021 ◽  
pp. 036354652110392
Author(s):  
Michael Constant ◽  
David P. Trofa ◽  
Bryan M. Saltzman ◽  
Christopher S. Ahmad ◽  
Xinning Li ◽  
...  
Keyword(s):  
Systematic Review ◽  
Statistical Significance ◽  
Patellofemoral Instability ◽  
Fragility Analysis ◽  
P Value ◽  
Level Of Evidence ◽  
Pubmed Database ◽  
Orthopaedic Literature ◽  
Comparative Trials

Background: Fragility analysis is increasingly utilized to evaluate the robustness of results within the orthopaedic literature and has frequently revealed instability of reported outcomes. Purpose/Hypothesis: The purpose of this investigation was to utilize a fragility analysis to evaluate the stability of reported results in the patellofemoral instability (PFI) literature. We hypothesized the demonstration of significant fragility in patellofemoral research to be similar to that identified throughout other areas of the orthopaedic literature. Study Design: Systematic review; Level of evidence, 4. Methods: The PubMed database was queried from January 1, 2000, to October 10, 2020 for comparative trials in 10 prominent orthopaedic journals that reported dichotomous outcomes related to the management of PFI. The fragility index (FI) and the fragility quotient (FQ) were calculated for each individual outcome event, and the overall FI and FQ were determined for all included studies. Results: A total of 22 comparative studies comprising 11 randomized controlled trials and 11 nonrandomized trials were included for the analysis. A total of 75 outcome events underwent a fragility analysis and revealed a median FI and FQ of 3 (interquartile range [IQR], 1-5) and 0.043 (IQR, 0.018-0.081), respectively. Also 27% of included studies reported loss to follow-up greater than the overall FI, therefore suggesting the maintenance of the follow-up may have resulted in the reversal of significance. Conclusion: The result of the comprehensive fragility analysis demonstrated a lack of robustness in PFI research with the alteration of only a few outcome events required to reverse statistical significance. We therefore recommend the triple reporting of the P value, the FI, and the FQ to aid in the interpretation of the statistical integrity of future comparative trials in the PFI literature.

Ultrasound-guided access to the axillary vein for implantation of cardiac implantable electronic devices: A systematic review and meta-analysis

2021 ◽  
pp. 112972982110546
Author(s):  
Sonia D’Arrigo ◽  
Francesco Perna ◽  
Maria Giuseppina Annetta ◽  
Mauro Pittiruti
Keyword(s):  
Systematic Review ◽  
Meta Analysis ◽  
Statistical Significance ◽  
Intervention Group ◽  
Late Complications ◽  
Control Group ◽  
Complication Rates ◽  
Axillary Vein ◽  
Cardiac Implantable Electronic Devices ◽  
The Us

The aims of our systematic review were to quantify the expected rate of procedural success, early and late complications during CIED implantation using US-guided puncture of the axillary vein and to perform a meta-analysis of those studies that compared the US technique (intervention) versus conventional techniques (control) in terms of complication rates. MEDLINE, ISI Web of Science, and EMBASE were searched for eligible studies. Pooled Odds Ratio (OR) and Pooled Mean Difference (PMD) for each predictor were calculated. The quality of evidence (QOE) was evaluated according to the GRADE guidelines. Thirteen studies were included a total of 2073 patients. The overall success of US-guided venipuncture for CIED implantation was 96.8%. As regards early complications, pneumothorax occurred in 0.19%, arterial puncture in 0.63%, and severe hematoma/bleeding requiring intervention in 1.1%. No cases of hemothorax, brachial plexus, or phrenic nerve injury were reported. As regards late complications, the incidence of pocket infection, venous thromboembolism, and leads dislodgement was respectively 0.4%, 0.8%, and 1.2%. In the meta-analysis (five studies), the intervention group (US-guided venipuncture) had a trend versus a lower likelihood of having a pneumothorax (0.19% vs 0.75%, p = 0.21), pocket hematoma (0.8% vs 1.7%, p = 0.32), infection (0.28% vs 1.05%, p = 0.29) than the control group, but this did not reach statistical significance. The overall QOE was low or very low. In conclusions we found that the US-guided axillary venipuncture for CIEDs implantation was associated with a low incidence of early and late complications and a steep learning curve.

scholarly journals Determinants of Perinatal birth Asphyxia among Newborns in Ethiopia: A Systematic Review and Meta-analysis of Observational Studies Protocol

2020 ◽  
Author(s):  
Abay Woday ◽  
Muluken Dessalegn ◽  
Setognal Birara ◽  
Kusse Urmale ◽  
Gebeyaw Biset ◽  
...  
Keyword(s):  
Systematic Review ◽  
Observational Studies ◽  
Associated Factors ◽  
Meta Analysis ◽  
Statistical Significance ◽  
Birth Asphyxia ◽  
Cochrane Library ◽  
P Value ◽  
African Countries ◽  
Significance Level

Abstract Background: Birth asphyxia among newborns accounted for nearly fifty percent of neonatal mortality in sub-Saharan African countries. This scenario has been worst in Ethiopia where every two out of three deaths attributed to birth asphyxia among these babies. Moreover, studies conducted in Ethiopia are highly variable and inconclusive to estimate the pooled prevalence and risk factors of birth asphyxia. Objective: This study aims to analyses collectively and systematically the prevalence of birth asphyxia and associated factors among newborns in Ethiopia.Methods: The protocol for this review is registered at PROSPERO with registration number CRD42020158224. A comprehensive online databases (PubMed, HINARI, Scopus, EMBASE, Science direct, and Cochrane library database), Google Scholar, African Journals online, other gray and online repository accessed studies will be searched using different search engines. In addition, maternity & infant care databases uploaded at Ethiopian Health Development Journal and Ethiopian Journal of Health Sciences will be searched until June 30, 2020. Newcastle-Ottawa Quality Assessment Scale (NOS) will be used for critical appraisal of studies.. Three reviewers will screen all retrieved articles, conduct data extraction, and then critically appraise all identified studies. All identified observational studies reporting the prevalence of birth asphyxia and associated factors among neonates in Ethiopia will be considered. The analysis of data will be done using STATA 11.0 statistical software. We will demonstrate pooled estimates and determinants of birth asphyxia with effect size and 95% confidence interval. Heterogeneity among the included studies will be assessed through the Cochrane Q-test statistics and I2 test. Publication bias will be checked using funnel plot and egger’s test. Finally, statistical significance level will be declared at a p-value of less than 0.05. Discussion: the result from this systematic review will inform and guide health policy planners to invest limited resources on maternal and neonatal health. Furthermore, it will be a stimulus for future cumulative meta-analysis researchers in developing nations.

Abstract P232: Psoriasis is Associated with Increased Arterial Stiffness: a Systematic Review and Meta-analysis

Hypertension ◽  
2016 ◽  
Vol 68 (suppl_1) ◽  
Author(s):  
Sikarin Upala ◽  
Anawin Sanguankeo
Keyword(s):  
Systematic Review ◽  
Arterial Stiffness ◽  
Observational Studies ◽  
Meta Analysis ◽  
Statistical Significance ◽  
Aortic Pulse Wave Velocity ◽  
P Value ◽  
Original Research ◽  
Cvd Risk ◽  
Non Invasive

Background: Studies have shown that patients with psoriasis have higher risk of CVD, independent of traditional CVD risk factors. However, pathophysiology of the development of CVD in psoriasis is not well known. Arterial stiffness has been recognized as an independent predictor of cardiovascular risk. It is controversial whether psoriasis and arterial stiffness is associated. In this systematic review and meta-analysis, we sought to assess the hypothesis that patients with psoriasis have increased arterial stiffness compared with controls. Methods: Systematic literature search was performed using MEDLINE and EMBASE databases from inception to May 2016. We included original research publications that contained data on arterial stiffness and psoriasis. Aortic pulse wave velocity (aPWV) is the non-invasive marker for assessment of arterial stiffness. We compared aPWV between patients with psoriasis and controls and estimated the pooled mean difference (MD) and 95% confidence interval (CI) of aPWV using a random-effects model meta-analysis. Results: Data from five observational studies involving 438 participants (233 with psoriasis) were extracted and included in the meta-analysis. Pooled MD of aPWV was 1.17 m/sec higher in patients with psoriasis compared with controls (95% CI: 0.78-1.55, P-value<0.01, I 2 = 69%). There is no change in the direction or statistical significance of MD of aPWV after removing each study at a time in the sensitivity analysis. Conclusion: Psoriasis is associated with increased arterial stiffness. Assessment of arterial stiffness parameters may be important for early detection of cardiovascular deterioration in psoriasis patients.

Classification and Management of Donor-Site Wound Complications in the Profunda Artery Perforator Flap for Breast Reconstruction

2019 ◽  
Vol 36 (02) ◽  
pp. 110-115
Author(s):  
Min-Jeong Cho ◽  
Sumeet S. Teotia ◽  
Nicholas T. Haddock
Keyword(s):  
Breast Reconstruction ◽  
Wound Care ◽  
Statistical Significance ◽  
Donor Site ◽  
Perforator Flap ◽  
Wound Dehiscence ◽  
Wound Complications ◽  
P Value ◽  
Type I ◽  
Artery Perforator

Abstract Background Profunda artery perforator (PAP) flap breast reconstruction has emerged as a popular choice for patients who are not optimal candidates for autologous breast reconstruction using abdominal-based techniques such as the deep inferior epigastric perforator flap. Despite increased utilization of PAP flaps, there are no previous studies on the donor-site morbidity. In this study, we present risk factors, classification of thigh wounds, and our management of donor-site wounds. Methods Retrospective review of 69 patients who underwent PAP flap from 2013 to 2016 was performed. Demographic, patient characteristic, and flap data were collected. Postoperative photographs of donor sites were reviewed, and the wounds were classified into three types: type I—normal wound, type II—minor scab, and type III—dehiscence. Results Of the 69 patients (130 flaps), there were 13 patients (17 flaps) with wound dehiscence (13%), 8 patients with cellulitis (8.5%), 2 patients with seroma (3%), and 1 patient with hematoma (1.5%). The patients with wound dehiscence had statistically higher body mass index (BMI) (29.2 vs. 26.5) with p-value < 0.05 than the patients without wound complications. These patients had higher flap weight (514 vs. 439.7 g), were older (50.8 vs. 48.6 years old), and had a higher chance of being a diabetic (6 vs. 2%), but statistical significance was not achieved. The patients with dehiscence were managed with local wound care (63%), wound vacuum (26%), and operative intervention (11%). Conclusion Our study shows that BMI plays a significant role in the development of postoperative thigh wounds, and all wounds occurred at the medial thigh. However, the majority of the study population did not require any intervention, and revision of scar using the posterior thigh advancement flaps can be used to improve the gluteal aesthetics. We believe findings from our study can help plastic surgeons to counsel and assist patients who will undergo breast reconstruction with a PAP flap.

Same Day versus Staged Total Knee Arthroplasty: Do Cost Savings Justify the Risk?

2020 ◽  
Author(s):  
Wayne Wilkie ◽  
Nequesha Mohamed ◽  
Ethan Remily ◽  
Mark Pastore ◽  
James Nace ◽  
...  
Keyword(s):  
Statistical Significance ◽  
Hospital Costs ◽  
Cost Savings ◽  
Inpatient Cost ◽  
Attractive Alternative ◽  
P Value ◽  
Complication Rates ◽  
Continuous Variables ◽  
Clinical Difference ◽  
Total Knee

AbstractSame-day bilateral total knee arthroplasties (BTKAs) are associated with increased complications compared with staged procedures; however, as complication rates and lengths of stay (LOS) for same-day procedures decrease, they may become attractive alternatives to staged procedures. The void of recent nationwide studies comparing the 30-day total cost and risks of these procedures inspired this propensity matched review. Therefore, we compared 30-day outcomes in staged and same-day BTKAs occurring in 2016 and 2017 using the National Readmission Database (NRD), a nationwide database. The NRD was queried for all same-day and staged BTKA patients from January 1 to November 30 for both 2016 and 2017. Since the NRD links readmissions within one calendar year, TKAs occurring in this month were excluded to allow 30-day follow-up. Propensity matching was performed based on demographics, producing 19,334 patients in both cohorts. Thirty-day readmission, revision, and mortality rates, hospital costs, LOS, discharge dispositions, and complications were analyzed. Chi-square and Student's t-tests assessed categorical and continuous variables, respectively. A p-value of <0.05 was set as the threshold for statistical significance. The analysis demonstrated that less same-day patients were readmitted, with statistical but not clinical difference in revisions, and mortality (all p < 0.050). Higher 30-day cost ($33,522 vs. $29,053, p < 0.001), decreased total LOS (4.52 vs. 4.94 days, p < 0.001), and lower rates of PEs (0.3 vs. 1.1%, p < 0.001) and transfusions (2.1 vs. 8.5%, p < 0.001) but similar total complications (p >0.050) were associated staged compared with same-day BTKAs. The results suggest inpatient cost savings associated with same-day surgeries should be weighed against the slight increase in LOS and PEs. Ultimately, as LOS and PE rates continue to decrease from innovations and quality improvements, same-day BTKA may become an attractive alternative to staged BTKAs, especially if payer's incentive surgeons by increasing physician reimbursements.

scholarly journals Effects of a telescopic intramedullary rod for treating patients with osteogenesis imperfecta of the femur

2018 ◽  
Vol 12 (1) ◽  
pp. 97-103 ◽  
Author(s):  
D. L. Rosemberg ◽  
E. O. Goiano ◽  
M. Akkari ◽  
C. Santili
Keyword(s):  
Osteogenesis Imperfecta ◽  
Cost Benefit ◽  
Patient Characteristics ◽  
Production Costs ◽  
Type I ◽  
Complication Rates ◽  
Level Of Evidence ◽  
Type Iii ◽  
Intramedullary Rod ◽  
Rod Migration

Purpose To introduce a new model of telescopic intramedullary rod (TIR), evaluate its effects on treating patients presenting with moderate and severe osteogenesis imperfecta (OI) and to compare the findings with those of other telescopic rods. Methods A total of 21 patients (nine girls and 12 boys; mean age at first operation, 6.6 years, 1.52 to 13.18) who underwent 52 femoral operations were monitored during a mean of 9.96 years (3.39 to 14.54). Patient characteristics, telescoping rod capability and its complications were examined. Results According to the Sillence classification, we investigated one patient with type I, nine with type III and 11 with type IV OI. Revision rates at up to five years (36%) were inferior to those found for the Fassier-Duval rod (46%). The main cause of revision was fracture (15 patients), followed by rod migration (nine), and infection (two). The rod exhibited higher telescopic capacity in boys than girls. Type III most commonly required an operation; the age group with the highest number of procedures was five to ten years. Male migration was the main cause of rod migration. Conclusion The TIR has a satisfactory cost-benefit ratio with less complication rates and low production costs. The TIR is a feasible alternative to the commonly used Fassier-Duval rod. Level of Evidence IV

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