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Nevin Manimala Statistics

Systematic review of risk prediction studies in bone and joint infection: are modifiable prognostic factors useful in predicting recurrence?

J Bone Jt Infect. 2021 Jul 8;6(7):257-271. doi: 10.5194/jbji-6-257-2021. eCollection 2021.

ABSTRACT

Background: Classification systems for orthopaedic infection include patient health status, but there is no consensus about which comorbidities affect prognosis. Modifiable factors including substance use, glycaemic control, malnutrition and obesity may predict post-operative recovery from infection. Aim: This systematic review aimed (1) to critically appraise clinical prediction models for individual prognosis following surgical treatment for orthopaedic infection where an implant is not retained; (2) to understand the usefulness of modifiable prognostic factors for predicting treatment success. Methods: EMBASE and MEDLINE databases were searched for clinical prediction and prognostic studies in adults with orthopaedic infections. Infection recurrence or re-infection after at least 6 months was the primary outcome. The estimated odds ratios for the primary outcome in participants with modifiable prognostic factors were extracted and the direction of the effect reported. Results: Thirty-five retrospective prognostic cohort studies of 92 693 patients were included, of which two reported clinical prediction models. No studies were at low risk of bias, and no externally validated prediction models were identified. Most focused on prosthetic joint infection. A positive association was reported between body mass index and infection recurrence in 19 of 22 studies, similarly in 8 of 14 studies reporting smoking history and 3 of 4 studies reporting alcohol intake. Glycaemic control and malnutrition were rarely considered. Conclusion: Modifiable aspects of patient health appear to predict outcomes after surgery for orthopaedic infection. There is a need to understand which factors may have a causal effect. Development and validation of clinical prediction models that include participant health status will facilitate treatment decisions for orthopaedic infections.

PMID:34285868 | PMC:PMC8283517 | DOI:10.5194/jbji-6-257-2021

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Nevin Manimala Statistics

Propensity Score Matching Analysis of the Effect of Payer Status on the Survival of Colon Cancer Patients

Cureus. 2021 Jun 18;13(6):e15748. doi: 10.7759/cureus.15748. eCollection 2021 Jun.

ABSTRACT

Background and objective Colon cancer is one of the most common types of cancer globally. The factors that could affect colon cancer survival include age, stage, treatment, and other socioeconomic aspects. Payer status has been shown to be a significant predictor of cancer patient survival in retrospective studies. However, due to the limitations of retrospective studies, patient baseline characteristics between payer statuses are not comparable. Few studies have addressed the effect of payer status on the overall survival (OS) of patients using propensity score matching (PSM). In light of this, we conducted a study to examine the effect of payer status on the survival of colon cancer patients based on PSM. Materials and methods About 66,493 stage II/III colon cancer patients aged 40-90 years and diagnosed between 2004 and 2015 were analyzed from a de-identified National Cancer Database (NCDB) file. All patients had undergone surgery, and patients who had received radiation therapy, hormone therapy, immunotherapy, palliative care, or therapies other than chemotherapy were excluded. Only private or Medicaid payer status was included. The propensity score was calculated by computing the probability of patients being in the Medicaid group using logistic regression. The PSMATCH procedure in the SAS software (SAS Inc., Gary, NC) was used to perform PSM on patients with Medicaid and private insurance. The greedy nearest neighbor matching method was used to match one Medicaid to one privately insured patient with a caliper of 0.2. At the same time, an exact match was done for gender, age group, race, and stage at diagnosis. Multivariate Cox regression was then used to estimate the effect of payer status on survival before and after PSM. Results Among the 66,493 patients, 90.3% were privately insured and 9.7% had Medicaid. In univariate analysis, payer status was found to be a significant predictor of OS. Prior to PSM, the median overall survival (MOS) for patients with private insurance was 12.75 years, while those with Medicaid had a MOS of 9.02 years. After PSM, 6,167 paired patients were matched, and patients with private insurance had a MOS of >12.82 years and Medicaid patients had a MOS of 8.88 years. After PSM, patients with Medicaid had a 50% increased risk of death, and payer status proved to be a statistically significant predictor of OS of colon cancer. Conclusion Based on our findings, as per the PSM method, payer status can be a significant predictor of survival among colon cancer patients. Also, chemotherapy, race, age, and other socioeconomic factors were also found to be significant predictors of OS. Further research should be conducted to investigate other covariates not studied here and the mediation effect of payer on the survival of cancer patients.

PMID:34285854 | PMC:PMC8286796 | DOI:10.7759/cureus.15748

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Nevin Manimala Statistics

The role of the brain-sparing effect of growth-restricted fetuses in newborn germinal matrix/intraventricular hemorrhage

J Perinat Med. 2021 Jul 20. doi: 10.1515/jpm-2021-0142. Online ahead of print.

ABSTRACT

OBJECTIVES: The aim of the study was to evaluate the effect of the brain-sparing effect (BSE) of fetal growth restriction (FGR) in newborn germinal matrix/intraventricular hemorrhage (GM/IVH).

METHODS: A total of 320 patients who delivered prior to the 34th gestational week were analyzed from data records. 201 patients were divided into two groups according to cerebro-placental ratio (CPR): early fetal growth restriction (FGR) with abnormal CPR group (n=104) and appropriate for gestational age with normal Doppler group (control) (n=97). Using the normal middle cerebral artery (MCA) Doppler as a reference, multivariate logistic regression analysis was used to assess the association between the BSE and the primary outcome.

RESULTS: The rate of Grade I-II Germinal matrix/intraventricular hemorrhage (GM/IVH) was 31(29.8%) in the group possessing early FGR with abnormal CPR and 7(7.2%) in the control group, showing a statistically significant difference. The rate of grade III-IV GM/IVH was 7(6.7%) in the group possessing early FGR with abnormal CPR and 2 (2.1%) in the control group, showing no statistically significant difference. We found that gestational age at delivery <32 weeks was an independent risk factor for GM/IVH. In addition, we found that other variables such as the presence of preeclampsia, fetal weight percentile <10, emergency CS delivery, 48-h completion after the first steroid administration and 24-h completion rate after MgSO4 administration were not independently associated with the primary outcome.

CONCLUSIONS: Our results indicate that the rate of GM-IVH was increased in the group possessing early FGR with abnormal CPR; however, multivariate logistic regression analysis showed that BSE was not an independent risk factor for GM/IVH.

PMID:34284527 | DOI:10.1515/jpm-2021-0142

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Association between latency period and perinatal outcomes after preterm premature rupture of membranes at 32-37 weeks of gestation: a perinatal registry-based cohort study

J Perinat Med. 2021 Jul 20. doi: 10.1515/jpm-2021-0082. Online ahead of print.

ABSTRACT

OBJECTIVES: To investigate association between latency after preterm premature rupture of membranes (PPROM) and perinatal outcomes at moderately and late preterm gestation.

METHODS: National perinatal registry-based cohort study using data for the period 2013-2018. Singleton pregnancies with non-malformed fetuses in cephalic presentation complicated by PPROM at 32+0-36+6 weeks were included. Associations between latency period and perinatal mortality, neonatal respiratory distress syndrome (RDS), early onset neonatal infection (EONI), and cesarean section were assessed using multiple logistic regression, adjusting for potential confounders (labor induction, maternal body-mass-index, maternal age, antenatal corticosteroids, and small-for-gestational-age). p<0.05 was considered statistically significant.

RESULTS: Of 3,017 pregnancies included, 365 (12.1%) had PPROM at 32+0-33+6 weeks and 2,652 (87.9%) at 34+0-36+6 weeks. Among all cases, 2,540 (84%) had latency <24 h (group A), 305 (10%) 24-47 h (group B), and 172 (6%) ≥48 h (group C). Longer latency was associated with higher incidence of EONI (adjusted odds ratio [aOR] 1.350; 95% confidence interval [CI] 0.900-2.026 for group B and aOR 2.500; 95% CI 1.599-3.911 for group C) and higher rate of caesarean section (aOR 2.465; 95% CI 1.763-3.447 for group B and aOR 1.854; 95% CI 1.172-2.932 for group C). Longer latency was not associated with rates of RDS (aOR 1.160; 95% CI 0.670-2.007 for group B and aOR 0.917; 95% CI 0.428-1.966 for group C).

CONCLUSIONS: In moderately to late PPROM, increased latency is associated with higher risk of EONI and cesarean section with no reduction in RDS.

PMID:34284530 | DOI:10.1515/jpm-2021-0082

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The impact of vestibular symptoms and electronystagmography results on recovery from sudden sensorineural hearing loss

J Basic Clin Physiol Pharmacol. 2021 Jul 20. doi: 10.1515/jbcpp-2020-0354. Online ahead of print.

ABSTRACT

OBJECTIVES: Idiopathic sudden sensorineural hearing loss (SSNHL) represents a frequently encountered otological entity, of various types and severity, with an array of associated symptoms including vertigo. This is a devastating life-changing condition with a blurry prognosis. The objective of this study was to determine the clinical association of vestibular impairment by electronystagmography (ENG) and caloric tests, and their ability to predict prognosis.

METHODS: An observational, crossectional study was carried out amongst patients admitted with SSNHL. Each consenting patient had an audiometry test performed on admission as well as ENG and caloric tests. Treatment included oral steroids and carbogen with intratympanic steroids used only as salvage treatment. Follow-up was completed after 6 months when hearing gains were evaluated. Finally, an association was sought between the rate of recovery and ENG and caloric test results.

RESULTS: Of 35 patients included, marked recovery was seen in patients without vertigo when compared to those with vertigo (p=0.003). A statistically significant association was found between the presence of vertigo and hearing deterioration (p=0.008). More so, normal electronystagmography results were associated with marked recovery (p=0.04).

CONCLUSIONS: The vestibular end organs are both subjectively and objectively affected in SSNHL as demonstrated by the abnormal ENG and caloric tests in our study despite the small sample size. Concomitant vestibular involvement carries poorer prognosis and routine identification may help foresee the recovery of patients with SSNHL and as such, aid in patient counseling. ENG and caloric tests are easily available and may be recommended for all patients with SSNHL.

PMID:34284525 | DOI:10.1515/jbcpp-2020-0354

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Nevin Manimala Statistics

Predictors for Prolonged Drain Use Following Autologous Breast Reconstruction

J Reconstr Microsurg. 2021 Jul 20. doi: 10.1055/s-0041-1731765. Online ahead of print.

ABSTRACT

BACKGROUND: Surgical drains are routinely used following autologous reconstruction, but are often cited as the leading cause of peri-operative discomfort. This study defined routine drain use duration and assessed the risk factors for prolonged breast and abdominal drain use during microvascular breast reconstruction, measures which have never previously been defined.

METHODS: Patients who underwent an abdominal microvascular free flap were included. Demographics, comorbidities, and operation-related characteristics were retrospectively collected in a prospectively maintained database. Statistical analysis utilized chi-square independent t-test, and linear regression analyses.

RESULTS: One hundred forty-nine patients comprising 233 breast flaps were included. Average breast and abdominal drain duration were 12.9 ± 3.9 and 17.7 ± 8.2 days, respectively. Prolonged breast and abdominal drain duration were defined as drain use beyond the 75th percentile at 14 and 19 days, respectively. Multivariable regression revealed hypertension was associated with an increased breast drain duration by 1.4 days (p = 0.024), axillary dissection with 1.7 days (p = 0.026), African-American race with 3.1 days (p < 0.001), Hispanic race with 1.6 days (p = 0.029), return to the OR with 3.2 days (p = 0.004), and each point increase in BMI with 0.1 days (p = 0.028). For abdominal drains, each point increase in BMI was associated with an increased abdominal drain duration by 0.3 days (p = 0.011), infection with 14.4 days (p < 0.001), and return to the OR with 5.7 days (p = 0.007).

CONCLUSION: Elevated BMI, hypertension, and axillary dissection increase risk for prolonged breast drain requirement in autologous reconstruction. African-American and Hispanic populations experience prolonged breast drain requirement after controlling for other factors, warranting further study.

PMID:34284504 | DOI:10.1055/s-0041-1731765

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Nevin Manimala Statistics

Out-of-Hospital Management of Diabetic Emergencies in Germany: Structural and Process Quality

Exp Clin Endocrinol Diabetes. 2021 Jul 20. doi: 10.1055/a-1523-7562. Online ahead of print.

ABSTRACT

AIMS: To collect and analyse representative data of structural and process quality in the management of diabetic emergencies in Germany in 2020.

METHODS: A standardised questionnaire comprising detailed items concerning clinically relevant parameters on the structural and process quality of out-of-hospital management of diabetic emergencies was sent nationwide to medical directors of emergency medical service districts (EMSDs). Results were compared with those from a similar study conducted in 2001.

RESULTS: The return rate of the questionnaires represented 126 EMSDs, serving a total population of > 40.1 million. Only 4% of ambulances carried glucagon (6% in 2001). In 2020, blood glucose determination increased significantly to 71% of all emergency interventions and to 29% of suspected cardiac emergencies (24% and 15%, respectively, in 2001). In 100% of EMSDs severe hypoglycaemia (SH) was treated by paramedics by administering intravenous dextrose before the arrival of a doctor compared to 63% in 2001. The potential value of nasal glucagon was acknowledged by 43% of responders. In selected patients, treatment of SH was conducted without hospital admission in 78% of EMDs (60% in 2001). Fifty-three percent of medical directors acknowledged the need for further training in diabetic emergencies (47% in 2001). Cooperation for medical education between emergency teams and a diabetes centre was reported by 14% (41% in 2001).

CONCLUSION: Structural and process quality of the management of diabetic emergencies in Germany has improved considerably since 2001. Persisting deficiencies could be improved by providing better medical equipment in ambulances and ongoing education to the entire emergency teams.

PMID:34284506 | DOI:10.1055/a-1523-7562

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Assessment of volumetric parameters derived from 68Ga-PSMA PET/CT in prostate cancer patients with biochemical recurrence: an institutional experience

Nucl Med Commun. 2021 Jul 19. doi: 10.1097/MNM.0000000000001459. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of this study was to evaluate the relationship between volumetric parameters calculated using semiautomatic quantification of lesions detected in 68Ga-labeled prostate-specific membrane antigen PET-computed tomography (68Ga-PSMA PET/CT) and clinical characteristics in prostate cancer (PCa) patients with biochemical recurrence.

METHODS: A total of 85 consecutive PCa patients with biochemical recurrence who underwent 68Ga-PSMA PET/CT at our institution from January 2019 to March 2020 were retrospectively assessed. 68Ga-PSMA PET/CT-derived volumetric parameters, including whole-body PSMA tumor volume (wbPSMA-TV) and whole-body total lesion PSMA (wbTL-PSMA), as well as the established maximum and mean standardized uptake value (SUVmax and SUVmean), were calculated for each patient. All PET-derived parameters were analyzed for correlation with prostate-specific antigen (PSA) levels and for association with Gleason scores.

RESULTS: Eighty-five patients with a mean age of 68.9 ± 7.8 years (range, 47-83 years) and a mean PSA level of 40.9 ± 92.1 ng/ml (range, 0.2-533.2 ng/ml) were analyzed. Volumetric parameters, that is, wbPSMA-TV and wbTL-PSMA, demonstrated a statistically significant correlation with PSA levels (r = 0.403 and r = 0.556, respectively, all at P < 0.001) and only the means of wbTL-PSMA were significantly different between the Gleason score groups (P < 0.05).

CONCLUSIONS: The results of our study indicate that 68Ga-PSMA PET/CT might be a valuable tool for the detection and follow-up of recurrence in PCa patients. 68Ga-PSMA PET/CT-derived quantitative volumetric parameters demonstrated a highly significant correlation with changes in PSA levels. Larger prospective studies are needed to help reveal the full potential of parameters such as PSMA-TV and TL-PSMA derived from PET imaging with 68Ga-PSMA.

PMID:34284438 | DOI:10.1097/MNM.0000000000001459

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Nevin Manimala Statistics

Assessment of the Effect of Amantadine in Patients with Traumatic Brain Injury: A Meta-Analysis

J Trauma Acute Care Surg. 2021 Jul 20. doi: 10.1097/TA.0000000000003363. Online ahead of print.

ABSTRACT

BACKGROUND: Traumatic brain injury is a global burden. We aimed to perform a meta-analysis to determine the efficacy of amantadine for cognitive performance after traumatic brain injury.

METHODS: The systematic review was prospectively registered on the PROSPERO website under the registration number CRD42017080044. We used PRISMA Guidelines to report the steps of meta-analysis. The search included electronic databases (PubMed, PsycINFO, Embase, Cochrane Library databases, CENTRAL, ProQuest and ClinicalTrials.gov trial registry). Critical care medicine journals and clinical neurology specialty were searched using www.scimagojr.com. No publication date restriction. Two authors assessed studies’ relevance and extracted data. Studies were assessed for quality using the Cochrane risk of bias tool. Data were analyzed using Comprehensive Meta-Analysis Program Versions 2.0 and 3.0.

RESULTS: 26 studies out of 3440 records were included in the systematic review, of which only 14 clinical trials and 6 observational studies were included in the meta-analysis. Amantadine significantly enhanced the cognitive function relative to control group (SMD 0.50; 95% CI 0.33 – 0.66; p < 0.001, 16 studies, 1127 participants, low certainty evidence). Consistent significant difference in favor of amantadine relative to control group (SMD = 0.79; 95% CI 0.34 – 1.24, very low certainty evidence) for cohort studies versus SMD = 0.40; 95% CI 0.25 – 0.56, moderate certainty evidence) for RCTS. Starting amantadine in the first week after TBI had a significant effect on improving cognitive function (SMD = 0.97; 95% CI 0.45 – 1.49, 16 studies, 1127 participants, low certainty). Amantadine showed a better effect when administered for less than one month (SMD = 0.83; 95% CI: 0.56 – 1.11, low certainty) and to patients below 18 years of age (SMD = 0.66; 95% CI: 0.32 – 0.99, low certainty) or to patients with less severe traumatic brain injury (SMD = 0.40; 95% CI 0.18 – 0.62, low certainty). No statistically significant difference existed between amantadine and the control concerning the adverse events (OR 1.74; 95% CI 0.88 – 3.44; p = 0.11, moderate certainty). Meta-regression of the different clinical parameters; onset of treatment, age and severity of traumatic brain injury showed a statistically significant relation between onset of treatment and the effect size of amantadine. The relation between the other two parameters and the effect size of amantadine showed a marginal statistical significance.

CONCLUSION: Amantadine may improve the cognitive function when used after TBI. Further research with high validity is needed to reach a solid conclusion about the use of amantadine in traumatic brain injury.

LEVEL OF EVIDENCE: Systematic review/ meta-analysis, level III.

PMID:34284464 | DOI:10.1097/TA.0000000000003363

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Validation of PROMIS-29 domain scores among adult burn survivors: A National Institute on Disability, Independent Living, and Rehabilitation Research Burn Model System Study

J Trauma Acute Care Surg. 2021 Jul 20. doi: 10.1097/TA.0000000000003365. Online ahead of print.

ABSTRACT

BACKGROUND: Patient-reported outcomes are important for understanding recovery after burn injury, benchmarking service delivery and measuring the impact of interventions. PROMIS-29 domains have been validated for use among diverse populations though not among burn survivors. The purpose of this study was to examine validity and reliability of PROMIS-29 scores in this population.

METHODS: PROMIS-29 scores of physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles, and pain interference were evaluated for validity and reliability in adult burn survivors. Unidimensionality, floor and ceiling effects, internal consistency, and reliability were examined. Differential item functioning (DIF) was used to examine bias with respect to demographic and injury characteristics. Correlations with measures of related constructs (Community Integration Questionnaire, Satisfaction with Life Scale, Post-Traumatic Stress Checklist-Civilian, and Veteran’s Rand-12) and known-group differences were examined.

RESULTS: 876 burn survivors with moderate to severe injury from 6 months-20 years post burn provided responses on PROMIS-29 domains. Participant ages ranged from 18-93 years at time of assessment; mean years since injury was 3.4. All PROMIS domain scores showed high internal consistency (Cronbach’s α = 0.87-0.97). There was a large ceiling effect on ability to participate in social roles (39.7%) and physical function (43.3%). One-factor confirmatory factor analyses supported unidimensionality (all CFI >0.95). We found no statistically significant bias (DIF). Reliability was high (>0.9) across trait levels for all domains except sleep, which reached moderate reliability (>0.85). All known-group differences by demographic and clinical characteristics were in the hypothesized direction and magnitude except burn size categories.

CONCLUSIONS: The results provide strong evidence for reliability and validity of PROMIS-29 domain scores among adult burn survivors. Reliability of the extreme scores could be increased and the ceiling effects reduced by administering PROMIS-43, which includes 6 items per domain, or by administering by computerized adaptive testing.

LEVEL OF EVIDENCE: This is a Level III psychometric analysis of prospectively collected survey data.

PMID:34284470 | DOI:10.1097/TA.0000000000003365