Category: Statistics

Indian J Ophthalmol. 2021 May;69(5):1135-1141. doi: 10.4103/ijo.IJO_2462_20.

ABSTRACT

PURPOSE: Patients with glaucoma undergoing trabeculectomy develop bleb cicatrix causing poor postoperative intraocular pressure (IOP) control and low success rates. Several approaches have been explored over the years for better outcomes. This study assesses the safety, efficacy, and outcome of trabeculectomy with HealaFlow^® (Anteis S. A, Geneva, Switzerland), a high-molecular-weight cross-linked hyaluronic acid viscoelastic gel, and comparing it with the antimetabolite Mitomycin-C (MMC).

METHODS: A prospective, interventional, case-controlled study conducted at a tertiary care hospital in Southern India on 60 eyes of patients requiring trabeculectomy divided in two groups – HealaFlow scleral implant and adjuvant low-dose MMC (0.1 mg/mL). Postoperative IOP reduction along with bleb morphology was assessed over follow-up at 1 week, 1 month, 3 months, 6 months, and 12 months.

RESULTS: Preoperatively IOP in the two groups was statistically similar. Postoperative IOP on day 1 had statistically significant reduction in both groups with greater reduction in MMC group. However, by 12 months, the IOP reduction was statistically similar in both groups, i.e., 46.24% (to 11.04 ± 2.55 mmHg) and 54.47% (to 11.99 ± 3.37 mmHg) in HealaFlow^® group and MMC group, respectively (P > 0.05). The bleb morphologies were similar and complications were seen equally, which resolved by 4 weeks. A complete success rate of 89.29% and a qualified success rate of 10.71% were observed equally in both groups.

CONCLUSION: Absorbable biosynthetic cross-linked hyaluronic acid and low-dose MMC are equally safe and efficacious in trabeculectomy with significant IOP reduction and good bleb morphology. Therefore, it is a novel substitute for MMC.

PMID:33913846 | DOI:10.4103/ijo.IJO_2462_20

JMIR Res Protoc. 2021 Apr 29;10(4):e18734. doi: 10.2196/18734.

ABSTRACT

BACKGROUND: The opioid epidemic has disproportionately impacted areas in the Appalachian region of the United States. Characterized by persistent Medicaid nonexpansion, higher poverty rates, and health care access challenges, populations residing in these areas of the United States have experienced higher opioid overdose death rates than those in other parts of the country. Jefferson County, Alabama, located in Southern Appalachia, has been especially affected, with overdose rates over 2 times greater than the statewide average (48.8 vs 19.9 overdoses per 10,000 persons). Emergency departments (EDs) have been recognized as a major health care source for persons with opioid use disorder (OUD). A program to initiate medications for OUD in the ED has been shown to be effective in treatment retention. Likewise, continued patient engagement in a recovery or treatment program after ED discharge has been shown to be efficient for long-term treatment success.

OBJECTIVE: This protocol outlines a framework for ED-initiated medications for OUD in a resource-limited region of the United States; the study will be made possible through community partnerships with referral resources for definitive OUD care.

METHODS: When a patient presents to the ED with symptoms of opioid withdrawal, nonfatal opioid overdose, or requesting opioid detoxification, clinicians will consider the diagnosis of OUD using the Diagnostic and Statistical Manual of Mental Disorders (fifth edition) criteria. All patients meeting the diagnostic criteria for moderate to severe OUD will be further engaged and assessed for study eligibility. Recruited subjects will be evaluated for signs and symptoms of withdrawal, treated with buprenorphine-naloxone as appropriate, and given a prescription for take-home induction along with an intranasal naloxone kit. At the time of ED discharge, a peer navigator from a local substance use coordinating center will be engaged to facilitate patient referral to a regional substance abuse coordinating center for longitudinal addiction treatment.

RESULTS: This project is currently ongoing; it received funding in February 2019 and was approved by the institutional review board of the University of Alabama at Birmingham in June 2019. Data collection began on July 7, 2019, with a projected end date in February 2022. In total, 79 subjects have been enrolled to date. Results will be published in the summer of 2022.

CONCLUSIONS: ED recognition of OUD accompanied by buprenorphine-naloxone induction and referral for subsequent long-term treatment engagement have been shown to be components of an effective strategy for addressing the ongoing opioid crisis. Establishing community and local partnerships, particularly in resource-limited areas, is crucial for the continuity of addiction care and rehabilitation outcomes.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18734.

PMID:33913818 | DOI:10.2196/18734

JMIR Mhealth Uhealth. 2021 Apr 29;9(4):e17581. doi: 10.2196/17581.

ABSTRACT

BACKGROUND: The relationship between intention and behavior has been well researched, but most studies fail to capture dynamic, time-varying contextual factors. Ecological momentary assessment through mobile phone technology is an innovative method for collecting data in real time, including time-use data. However, only a limited number of studies have examined day-level plans to be physically active and subsequent physical activity behavior using real-time time-use data to better understand this relationship.

OBJECTIVE: This study aims to examine whether plans to be physically active (recorded in advance on an electronic calendar) were associated with objectively assessed physical activity (accelerometry), to identify activities that replaced planned periods of physical activity by using the mobile app Life in a Day (LIAD), and to test the feasibility and acceptability of LIAD for collecting real-time time-use data.

METHODS: The study included 48 university students who were randomly assigned to 1 of 3 protocols, which were defined by 1, 3, or 5 days of data collection. Participants were asked to record their planned activities on a Google Calendar and were provided with mobile phones with LIAD to complete time-use entries in real time for a set of categories (eg, exercise or sports, eating or cooking, school, or personal care). Participants were instructed to wear an accelerometer on their nondominant wrist during the protocol period. A total of 144 days of protocol data were collected from the 48 participants.

RESULTS: Protocol data for 123 days were eligible for analysis. A Fisher exact test showed a statistically significant association between plans and physical activity behavior (P=.02). The congruence between plans and behavior was fair (Cohen κ=0.220; 95% CI 0.028-0.411). Most participants did not plan to be active, which occurred on 75.6% (93/123) of days. Of these 93 days, no physical activity occurred on 76 (81.7%) days, whereas some physical activity occurred on 17 (18.3%) days. On the remaining 24.4% (30/123) of days, some physical activity was planned. Of these 30 days, no physical activity occurred on 18 (60%) days, whereas some physical activity occurred on 12 (40%) days. LIAD data indicated that activities related to screen time most often replaced planned physical activity, whereas unplanned physical activity was often related to active transport. Feasibility analyses indicated little difficulty in using LIAD, and there were no significant differences in feasibility by protocol length.

CONCLUSIONS: Consistent with previous literature, physical activity plans and physical activity behaviors were linked, but not strongly linked. LIAD offers insight into the relationship between plans and behavior, highlighting the importance of active transport for physical activity and the influence of screen-related behaviors on insufficient physical activity. LIAD is a feasible and practical method for collecting time-use data in real time.

PMID:33913812 | DOI:10.2196/17581

J Endourol. 2021 Apr 29. doi: 10.1089/end.2020.1181. Online ahead of print.

ABSTRACT

BACKGROUND: To determine predictive formulas for operation time and surgical difficulty in laparoscopic living-donor kidney transplantation.

METHODS: We retrospectively analyzed data for 222 living donors aged > 20 years and recorded factors affecting operation time from patients’ computed tomography images and medical records. We used the factors significantly affecting operation time to create a formula to predict operation time and designed a model to predict surgical difficulty based on the standardized partial regression coefficient, β. We also analyzed the relationship between surgical difficulty (high vs low) and operation time.

RESULTS: This study involved 111 pure retroperitoneal donor nephrectomies (PRDN) and 111 hand-assisted laparoscopic donor nephrectomies (HALDN). Patients’ mean age was 55.7 years, and 59.5% were women; 5.0% underwent right nephrectomy, and 77.0% vs. 23.0% had single- vs. multiple renal arteries. The average estimated kidney graft weight was 160.0 g; actual average graft weight was 155.3 g. The following factors were significantly correlated with operation time in the regression analysis: number of renal arteries, Mayo adhesive probability (MAP) score, estimated kidney graft weight, right nephrectomy, and operation type (PRDN). These five factors were used to create the operation time prediction equation and difficulty scoring system. The multiple r2 value was 0.40 for the operation time prediction equation. Receiver operating characteristic curve analysis of the difficulty scoring system revealed the following: sensitivity: 78.0%, specificity: 64.9%, and c-statistic: 0.76 (95% confidence interval: 0.70-0.83).

CONCLUSIONS: The equation to predict operation time and the surgical difficulty prediction model created in this study are easy to calculate and are accurate. Both may help in selecting an appropriately-skilled surgeon and in improving safety in living-donor kidney transplantation.

PMID:33913754 | DOI:10.1089/end.2020.1181

Breastfeed Med. 2021 Apr 28. doi: 10.1089/bfm.2020.0336. Online ahead of print.

ABSTRACT

Objective: This study examined the effect of postpartum administration of depo medroxyprogesterone acetate (DMPA) on milk production, time to onset of secretory activation, lactation duration, and infant consumption of mother’s own milk (MOM) in mothers of preterm very low-birth-weight (VLBW) infants. Materials and Methods: We conducted a secondary analysis of data from mothers who delivered infants weighing ≤1,500 g and at ≤32 weeks’ gestation. The volume of milk produced was measured on days 1-7, 14, and 21 by weighing all expressed milk on an electronic scale. Time to secretory activation was determined through self-report of a feeling of breast fullness. Information on lactation duration and the percent of feeds consisting of MOM consumed by infants was obtained from the medical records. Results: Mothers who received postpartum DMPA were more likely to be African American (72.4% versus 31.4%; p = 0.0006), unemployed (65.5% versus 44.5%; p = 0.027), and Medicaid eligible (89.7% versus 67.2%; p = 0.019). There were no differences in daily milk production between mothers who received DMPA before hospital discharge (n = 29) compared with those who did not (n = 141). When mothers who reached secretory activation before receiving DMPA were removed from analysis, receiving DMPA was associated with a later onset of secretory activation (103.7 versus 88.6 hours; p = 0.028). There were no statistically significant differences between the study groups in lactation duration or infant MOM consumption. Conclusions: DMPA, when administered postpartum to mothers of preterm VLBW infants, delayed secretory activation, but had no detrimental effect on milk production or lactation duration. Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT01892085.

PMID:33913765 | DOI:10.1089/bfm.2020.0336

Environ Technol. 2021 Apr 29:1-24. doi: 10.1080/09593330.2021.1924866. Online ahead of print.

ABSTRACT

A continuous electrocoagulation reactor, with curved electrodes, polarity switch, and cylindrical geometry, was used for emulsified crude oil in water separation. Apparatus novelty consists of an inlet arranged to promote a circular flow regime. The effects of flow rate (2 and 6 mL.s^-1), electrical current (2 and 4 A), and distance between electrodes (1.5 and 2.5 cm) were investigated using a full factorial design and statistical analysis. Using 6 mL.s^-1 flow rate, 2 A electric current and 2.5 cm electrode distance; 86% oil removal was obtained at a pH < 9.0. For this configuration, the system will process 21.6 L of oily emulsion while consuming 6.92 Wh. Oil removal increased with flow rate, a novel characteristic created by the unusual geometry of the system.

PMID:33913794 | DOI:10.1080/09593330.2021.1924866

J Phys Chem A. 2021 Apr 29. doi: 10.1021/acs.jpca.1c02393. Online ahead of print.

ABSTRACT

The photodissociation of jet-cooled cyclohexyl was studied by exciting the radicals to their 3p Rydberg state by using 248 nm laser light and detecting photoproducts by photofragment translational spectroscopy. Both H atom loss and dissociation to heavy fragment pairs are observed. The H atom loss channel exhibits a two-component translational energy distribution. The fast photoproduct component is attributed to impulsive cleavage directly from an excited state, likely the Rydberg 3s state, forming cyclohexene. The slow component is due to statistical decomposition of hot cyclohexyl radicals that internally convert to the ground electronic state prior to H atom loss. The fast and slow components are present in an ∼0.7:1 ratio, similar to findings in other alkyl radicals. Internal conversion to the ground state also leads to ring-opening followed by dissociation to 1-buten-4-yl + ethene in comparable yield to H-loss, with the C₄H₇ fragment containing enough internal energy to dissociate further to butadiene via H atom loss. A very minor ground-state C₅H₈ + CH₃ channel is observed, attributed predominantly to 1,3-pentadiene formation. The ground-state branching ratios agree well with RRKM calculations, which also predict C₄H₆ + C₂H₅ and C₃H₆ + C₃H₅ channels with similar yield to C₅H₈ + CH₃. If these channels were active, it was at levels too low to be observed.

PMID:33913714 | DOI:10.1021/acs.jpca.1c02393

AIDS Res Hum Retroviruses. 2021 Apr 29. doi: 10.1089/AID.2021.0012. Online ahead of print.

ABSTRACT

People with HIV (PWH) might have a higher risk of adverse coronavirus disease 2019 (COVID-19) outcomes. Several scores were developed to predict COVID-19 progression to critical disease and are often used among PWH. We assessed the performance of two commonly used risk equations among PWH and COVID-19.

METHODS: Participants were identified from a multicenter cohort of 6,361 PWH on regular follow-up at two university hospitals. Of 99 HIV-infected individuals with confirmed SARS-CoV-2 infection, 63 had complete data and were included in this analysis. CALL and COVID-GRAM scores were calculated and participants were stratified into low, intermediate, and high-risk for each. Discrimination was assessed using receiver operating characteristic curves. Calibration was evaluated using observed-versus-expected ratios and Hosmer-Lemeshow X2 goodness of fit statistic. Scores were adjusted by increasing one category level in individuals with nadir CD4 lymphocyte count <200/µL.

RESULTS: Participants had a median nadir and current CD4 counts of 207 (interquartile range, IQR, 119-345) and 440 (IQR 280-719) cells/µL. Ten (15.9%) individuals progressed to critical disease and 4 (6.3%) died. Assessed scores showed acceptable discrimination (area under the curve, 0.701-0.771) and were overall calibrated (observed-versus-expected ratio, O:E, 1.01). However, both overestimated the risk of progression among individuals in the low and high-risk categories, and underestimated the risk in the intermediate category (O:E 1.20-1.21). Thus, 50% of critically ill individuals were not identified as high-risk. Assigning PWH with low nadir CD4 count a higher risk of progression reduced the proportion of individuals not identified to 20%.

CONCLUSIONS: COVID-19 risk scores had lower performance in PWH compared to that described in the general population and failed to adequately identify individuals who progressed to critical disease. Adjustment for nadir CD4 partially improved their accuracy. Risk equations incorporating HIV-related factors are needed.

PMID:33913732 | DOI:10.1089/AID.2021.0012

Ital J Dermatol Venerol. 2021 Apr 29. doi: 10.23736/S2784-8671.21.06840-1. Online ahead of print.

ABSTRACT

BACKGROUND: Mortality of bullous pemphigoid(BP) is a variable parameter,depending especially on the area where the study was conducted.The 1-year mortality rate and the identification of clinictherapeutic factors with potential prognostic value in patients with BP were evaluated in a cohort from a single referral center.

METHODS: We have reviewed medical records of patients with BP diagnosed at the Sant’Orsola-Malpighi Hospital in Bologna(Italy) between 2005 and 2019.Data collected included sex,age at diagnosis,laboratory findings,severity of disease,dosage of systemic treatments,age at death and comorbidities.Only patients who had at least 1 year of follow-up were included.

RESULTS: 85 patients were included; the mortality rate was 7.1%.The mortality rate of patients treated with a moderate dosage of corticosteroids was no higher than that of patients treated with a low dosage.The log-rank test showed a statistically significant correlation between mortality and patients aged≥85,BP230 positive,and CCIS≥4.

CONCLUSIONS: Compared with similar studies,our results show a lower 1-year mortality rate.Advanced age at diagnosis and CCIS were confirmed as major independent factors associated with poor prognosis in BP.Administration of moderate dosage of oral corticosteroids seems to have an overall positive benefit-risk ratio,providing a good control of the disease and minimizing the risk of hospitalization,possible related complications and the mortality rate.

PMID:33913666 | DOI:10.23736/S2784-8671.21.06840-1

Anal Chem. 2021 Apr 29. doi: 10.1021/acs.analchem.0c05279. Online ahead of print.

ABSTRACT

Hydrogen exchange-mass spectrometry (HX-MS) is widely recognized for its potential utility for establishing the equivalence of the higher-order structures of proteins, particularly in comparability and similarity contexts. However, recent progress in the statistical analysis of HX-MS data has instead placed an emphasis on significance testing to identify regions of proteins where there are significant differences in HX between two or more protein states. In the cases involving assessment of similarity or equivalence of the higher-order structure of different protein samples (e.g., biosimilars), significance testing of HX-MS data is unsuitable. To meet this need, we have adapted the univariate two one-sided test (TOST) equivalence testing method for HX-MS data. Equivalence acceptance criteria were determined using maximum deviations from randomized resampling of truly equivalent samples to define hybrid equivalence criteria (maximum deviation of true equivalents, MDTE). Application of the TOST-MDTE test on differential HX-MS measurements of wild-type and mutated maltose-binding proteins demonstrates that the equivalence testing method was fit-for-purpose. Three infliximab biosimilars (Remsima, Renflexis, and Inflectra) were found to be equivalent to their Remicade reference product based on differential HX-MS measurements, while 5% deglycosylated NIST mAb was not statistically equivalent to the unmodified NIST mAb reference.

PMID:33913686 | DOI:10.1021/acs.analchem.0c05279