Category: Statistics

J Transcult Nurs. 2021 Mar 10:1043659621999829. doi: 10.1177/1043659621999829. Online ahead of print.

NO ABSTRACT

PMID:33719744 | DOI:10.1177/1043659621999829

Med Decis Making. 2021 Mar 10:272989X21994553. doi: 10.1177/0272989X21994553. Online ahead of print.

ABSTRACT

BACKGROUND: Surrogate endpoints (i.e., intermediate endpoints intended to predict for patient-centered outcomes) are increasingly common. However, little is known about how surrogate evidence is handled in the context of health technology assessment (HTA).

OBJECTIVES: 1) To map methodologies for the validation of surrogate endpoints and 2) to determine their impact on acceptability of surrogates and coverage decisions made by HTA agencies.

METHODS: We sought HTA reports where evaluation relied on a surrogate from 8 HTA agencies. We extracted data on the methods applied for surrogate validation. We assessed the level of agreement between agencies and fitted mixed-effects logistic regression models to test the impact of validation approaches on the agency’s acceptability of the surrogate endpoint and their coverage recommendation.

RESULTS: Of the 124 included reports, 61 (49%) discussed the level of evidence to support the relationship between the surrogate and the patient-centered endpoint, 27 (22%) reported a correlation coefficient/association measure, and 40 (32%) quantified the expected effect on the patient-centered outcome. Overall, the surrogate endpoint was deemed acceptable in 49 (40%) reports (k-coefficient 0.10, P = 0.004). Any consideration of the level of evidence was associated with accepting the surrogate endpoint as valid (odds ratio [OR], 4.60; 95% confidence interval [CI], 1.60-13.18, P = 0.005). However, we did not find strong evidence of an association between accepting the surrogate endpoint and agency coverage recommendation (OR, 0.71; 95% CI, 0.23-2.20; P = 0.55).

CONCLUSIONS: Handling of surrogate endpoint evidence in reports varied greatly across HTA agencies, with inconsistent consideration of the level of evidence and statistical validation. Our findings call for careful reconsideration of the issue of surrogacy and the need for harmonization of practices across international HTA agencies.

PMID:33719711 | DOI:10.1177/0272989X21994553

J Am Psychiatr Nurses Assoc. 2021 Mar 14:1078390321999725. doi: 10.1177/1078390321999725. Online ahead of print.

ABSTRACT

BACKGROUND: Although previous studies have separately revealed that parameters such as anxiety, depression, and secondary traumatic stress (STS) are associated with burnout, there is still a limited understanding of the relationship between anxiety, depression, and STS and burnout in intensive care unit (ICU) nurses.

AIMS: To investigate the relationship between levels of burnout, anxiety, depression, and STS in ICU nurses.

METHOD: A cross-sectional study was conducted with ICU nurses (N = 164) from a university hospital in eastern Turkey. The participants completed the anxiety, depression, STS, and burnout scales along with the descriptive characteristics form. The data were analyzed using descriptive statistics, correlation, and logistic regression analysis.

RESULTS: The mean scores for STS, anxiety, depression, and burnout were 40.60 ± 13.77, 17.14 ± 12.90, 13.28 ± 9.75 and 41.39 ± 14.87, respectively. The results showed that, in the ICU nurses, anxiety, depression, and STS components explained 61% of emotional exhaustion, 38% of depersonalization, and 13% of personal accomplishment.

CONCLUSIONS: While the present findings supported the paradigm that burnout in ICU nurses is associated with STS, anxiety, and depression, they also revealed some details about the psychopathological factors associated with burnout. These details were as follows: (1) individuals who resorted to avoidance as a component of STS on a high level were more likely to experience emotional exhaustion and depersonalization, (2) individuals with severe depressive symptoms were more likely to experience a decrease in their personal accomplishment, and (3) individuals with anxiety symptoms were more likely to experience both emotional exhaustion and personal accomplishment.

PMID:33719680 | DOI:10.1177/1078390321999725

J Orthod. 2021 Mar 15:14653125211001079. doi: 10.1177/14653125211001079. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the colour stability of polymeric resins that could be used to 3D-print orthodontic brackets.

DESIGN: In vitro, laboratory study.

MATERIALS AND METHODS: Disc-shaped specimens were fabricated via 3D printing using three resins: Dental LT; Dental SG; and Clear. Five conditions were evaluated for each resin (n = 10 per treatment per resin) to assess its corresponding effect on colour and translucency: immersion in (1) red wine, (2) coffee, (3) tea and (4) distilled water (control), and (5) exposure to accelerated aging. Colour and translucency measurements were made before and after exposure using a spectrophotometer. Mean colour differences (ΔE₀₀) and changes in translucency parameter (ΔTP₀₀) were calculated for each sample using the CIEDE2000 colour difference formula.

RESULTS: Statistically significant effects of the resin material, the treatment condition and interactions effects of material and condition were observed for ΔE₀₀ and ΔTP₀₀ (P < 0.001). The most pronounced changes in colour (ΔE₀₀) were a result of the staining effects of wine on all three resins, ranging from 14.5 ± 0.6 to 20.8 ± 1.2. Dental LT, Dental SG and Clear resins all showed changes in colour when exposed to certain staining agents. Dental SG and Clear resins exhibited changes in colour with aging, while the colour of Dental LT resin remained stable with aging.

CONCLUSIONS: The colour changes of the resins investigated does not support their use in 3D-printed aesthetic bracket applications.

PMID:33719707 | DOI:10.1177/14653125211001079

Foot Ankle Int. 2021 Mar 10:1071100721995427. doi: 10.1177/1071100721995427. Online ahead of print.

ABSTRACT

BACKGROUND: Microfracture is the most common reparative surgery for osteochondral lesions of the talus (OLTs). While shown to be effective in short- to midterm outcomes, the fibrocartilage that microfracture produces is both biomechanically and biologically inferior to that of native hyaline cartilage and is susceptible to possible deterioration over time following repair. With orthobiologics being proposed to augment repair, there exists a clear gap in the study of long-term clinical outcomes of microfracture to determine if this added expense is necessary.

METHODS: A retrospective review of patients undergoing microfracture of an OLT with a single fellowship-trained orthopedic surgeon from 2007 to 2009 was performed. Patients meeting the inclusion criteria were contacted to complete the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) and Sports subscales and visual analog scale (VAS) for pain, as well as surveyed regarding their satisfaction with the outcome of the procedure and their likelihood to recommend the procedure to a friend with the same problem using 5-point Likert scales. Patient demographics were reviewed and included for statistical analysis.

RESULTS: Of 45 respondents, 3 patients required additional surgery on their ankle for the osteochondral defect, yielding a 10-year survival rate of 93.3%. Of surviving cases, 90.4% (38/42) reported being “extremely satisfied” or “satisfied” with the outcome of the procedure. The VAS score at follow-up averaged 14 out of 100 (range, 0-75), while the FAAM-ADL and FAAM-Sports scores averaged 90.29 out of 100 and 82 out of 100, respectively. Thirty-six patients (85.7%) stated that their ankle did not prevent them from participating in the sports of their choice.

CONCLUSION: The current study represents a minimum 10-year follow-up of patients undergoing isolated arthroscopic microfracture for talar osteochondral defects, with a 93.3% survival rate and 85.7% return to sport. While biological adjuvants may play a role in improving the long-term outcomes of microfracture procedures, larger and longer-term follow-up studies are required for procedures using orthobiologics before their cost can be justified for routine use.

LEVEL OF EVIDENCE: Level IV, retrospective cohort case series study.

PMID:33719632 | DOI:10.1177/1071100721995427

Eur J Ophthalmol. 2021 Mar 15:11206721211000646. doi: 10.1177/11206721211000646. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate the role of ICRS in halting keratoconus progression in a large sample of patients.

METHODS: A retrospective, non-comparative, interventional study based on the review of medical records of patients diagnosed with keratoconus who underwent Ferrara corneal ring segment implantation. A retrospective chart analysis study of 123 operated eyes with follow-up ranging from 3 to 16 years (mean 5.3 ± 3.6 years) was performed. This study was carried out at Ocular Surgery Unit, São Paulo, Brazil. All topographic data were obtained from Pentacam (Oculus, Arlington, USA). The same surgeon performed all surgeries, and the Ferrara ICRS nomogram was used for ICRS selection in all cases.

RESULTS: Corrected distance visual acuity, keratometry, and topographic astigmatism improved in most cases, with statistical significance. In 42 eyes (53.8%), there was an increase in K1 or K2, and in 36 (46.2%), there was a reduction or maintenance in K1. Considering a difference higher than 1 D, between 3-month post-surgery and final visit (group 3), 32 eyes (41%) showed an increase, and 46 eyes (59%) ended equal or below this value.

CONCLUSION: The implantation of ICRS showed improvement in visual and keratometric indexes. The majority of patients did not increase more than one diopter in keratometric values after ICRS implantation. ICRS may be effective for slowing disease progression, especially in older patients.

PMID:33719637 | DOI:10.1177/11206721211000646

Int J Soc Psychiatry. 2021 Mar 14:207640211001084. doi: 10.1177/00207640211001084. Online ahead of print.

ABSTRACT

BACKGROUND: The underutilization of mental health services is a recognized problem for the growing number of Muslims living in the West. Despite their unique mental health risk factors and the pivotal role they play in determining mental health discourse in their families and in society, Muslim women in particular have not received sufficient study.

AIM: To help remedy this research gap, we examined factors that may impact the rejection attitudes of Muslim women toward professional mental health care using the first psychometrically validated scale of its kind; the M-PAMH (Muslims’ Perceptions and Attitudes to Mental Health).

METHODS: A total of 1,222 Muslim women responded to questions about their cultural and religious beliefs about mental health, stigma associated with mental health, and familiarity with formal mental health services in an anonymous online survey.

RESULTS: Hierarchical multiple regression analysis revealed that higher religious and cultural beliefs, higher societal stigma, and lower familiarity with professional mental health services were associated with greater rejection attitudes toward professional mental healthcare. The final model was statistically significant, F (5, 1,216) = 73.778; p < .001, and explained 23% of the variance in rejection attitudes with stigma accounting for the most (12.3%) variance, followed by cultural and religious mental health beliefs (6%), and familiarity with mental health services (2.7%).

CONCLUSIONS: Findings suggest that although the examined factors contributed significantly to the model, they may not be sufficient in the explanation of Muslim women’s rejection attitudes toward mental health services. Future research may explore additional variables, as well as predictive profiles for Muslim women’s perceptions and attitudes of mental health based on a combination of these factors.

PMID:33719665 | DOI:10.1177/00207640211001084

Arthroscopy. 2021 Mar 11:S0749-8063(21)00221-8. doi: 10.1016/j.arthro.2021.02.044. Online ahead of print.

ABSTRACT

PURPOSE: The purpose of this study is to determine the efficacy of amniotic suspension allograft (ASA) compared to hyaluronic acid (HA) and saline at up to 12 months of follow-up through the use of patient-reported outcomes, immunoglobulin levels, and anti-HLA levels.

METHODS: Within this multicenter study, 200 patients were randomized 1:1:1 to a single intra-articular injection of saline, HA, or ASA. Patient-reported outcomes (PROs), including Knee Injury and Osteoarthritis Outcome Score (KOOS) and Visual Analog Score (VAS), were collected at multiple time points (baseline, 1 week, 6 weeks, 3 months, 6 months) out to 12 months to assess improvements in pain and function. Radiographs at baseline and 12 months were taken to determine radiographic changes, while blood was collected at baseline, 6 weeks, and 6 months to determine changes in immunoglobulins and anti-HLA levels. Statistical analyses were performed using Last Observation Carried Forward (LOCF) and Mixed Effects Model for Repeated Measures (MMRM).

RESULTS: Treatment with ASA resulted in significant improvements in KOOS and VAS scores that were maintained through 12 months (p<0.05). Treatment with ASA resulted in a 63.2% responder rate at 12 months using the OMERACT-OARSI simplified definition. There were no significant differences between groups for radiographic measures in the index knee, immunoglobulins, C-reactive protein (CRP), or anti-HLA serum levels (p>0.05). The number and type of adverse events (AEs) reported for ASA was comparable to the HA injection group, while no treatment-emergent AEs were reported for the saline group.

CONCLUSION: This randomized controlled trial of ASA versus HA and saline for the treatment of symptomatic knee OA demonstrated clinically meaningful improved outcomes with ASA over the controls out to 12 months post-injection. No concerning immunological or adverse reactions to the ASA injection was identified with regards to severe adverse events, immunoglobulin or anti-HLA levels.

PMID:33716121 | DOI:10.1016/j.arthro.2021.02.044

Life Sci. 2021 Mar 11:119336. doi: 10.1016/j.lfs.2021.119336. Online ahead of print.

ABSTRACT

AIMS: This study aimed to explore the therapeutic effects of amniotic fluid-derived extracellular vesicles including exosomes (AF-Exos) on the recovery of sperm production capacity in a rat model of azoospermia.

MAIN METHODS: The non-obstructive azoospermia (NOA) was induced in rats using intratesticular administration of Busulfan. Azoospermia was confirmed by testis histology. AF-Exos samples containing 10 or 40 μg exosomal proteins were injected into testicular tissue of NOA rats. After two months, the recovery of spermatogenesis was monitored via histopathological staining, spermiogram, and hormonal analysis. Immunohistochemistry staining for OCT-3/4 was used to identify of spermatogonial progenitors. The expression of DAZL and VASA, was also measured.

KEY FINDINGS: AF-Exos exhibited sphere-shaped morphology with the mean diameter and zeta potential of 50 ± 7.521 nm and -7.16 mV. Immunoblots revealed that isolated nanoparticles were CD63, CD9, and CD81 positive. Histopathological evaluation revealed that spermatogenesis was improved significantly in NOA rats after AF-Exos injection. Data showed that the sperm parameters and spermatogenesis index were significantly improved after AF-Exos injection compared to azoospermic groups. OCT-3/4⁺ cells were increased in NOA rats after AF-Exos injection, showing the restoration of spermatogenesis. In the present study, both doses of exosome (10 and 40 μg) restored the testicular function of NOA rats. DAZL and VASA were increased significantly in animals who received 40 μg exosomal protein compared to azoospermic rats. Except in a high dose of AF-Exos (40 μg) for Testosterone and FSH, no statistically significant differences were found regarding hormones post-exosome injection.

SIGNIFICANCE: Our study demonstrated that AF-Exos regenerated spermatogenesis and improved sperm quality in NOA rats.

PMID:33716061 | DOI:10.1016/j.lfs.2021.119336

Am J Obstet Gynecol. 2021 Mar 11:S0002-9378(21)00163-0. doi: 10.1016/j.ajog.2021.03.012. Online ahead of print.

ABSTRACT

BACKGROUND: Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Sacrospinous hysteropexy with graft (vaginal mesh hysteropexy) is an alternative, although in 2019 the FDA removed this mesh product from the U.S. market.

OBJECTIVE: Our objective was to compare the efficacy and adverse events of these two procedures.

STUDY DESIGN: At 9 clinical sites in the U.S. NIH/NICHD Pelvic Floor Disorders Network, 183 postmenopausal women requesting vaginal surgery for symptomatic uterovaginal prolapse were enrolled in a multi-site randomized superiority clinical trial; comparing a sacrospinous hysteropexy with graft (hysteropexy) to a vaginal hysterectomy with uterosacral ligament suspension (hysterectomy). Participants consented to remain masked to treatment assignment for the study duration. Study visits were conducted at 6-month intervals through 60 months. The primary treatment failure composite outcome (retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival modeling. Secondary outcomes included complications or adverse events, individual anatomic measures of the POP-Q examination, and presence, severity and impact/bother of prolapse, urinary, bowel, and pain symptoms as measured by validated questionnaires. The 3 year published results suggested better primary outcomes with sacrospinous hysteropexy with graft, but the differences were not statistically significant (p=0.06). This study reports the 5 year outcomes.

RESULTS: One hundred and eighty three women with a mean age of 66 years were randomized between April 2013 and February 2015, 93 were randomized to hysteropexy and 90 were randomized hysterectomy. One hundred seventy-five (175) were included in the trial, and 156 (89%) completed the 5 year follow-up. The primary outcome showed fewer failures for hysteropexy compared to hysterectomy through 5 years (adjusted hazard ratio, 0.58 [95% CI: 0.36 to 0.94], p=0.03), with failure rates of 37% vs 54%, respectively, resulting in a difference of -18% (95% CI: -33% to -3%) at 5 years. With the exception of the Urogenital Distress Inventory, no group differences were demonstrated in patient reported pelvic floor symptoms, prolapse symptoms, bowel function symptoms, general quality of life, body image, or pelvic pain. At their last visit through 5 years, 70% (129/183) of participants reported they remained masked to their treatment with no difference in masking between groups. Adverse events for hysteropexy vs hysterectomy included mesh exposure (8% vs 0%), granulation tissue after 12 weeks (1% vs 12%), and suture exposure after 12 weeks (3% vs 21%), respectively.

CONCLUSION: Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, sacrospinous hysteropexy with graft resulted in a lower composite failure rate compared to vaginal hysterectomy through 5 years. There were no meaningful differences in patient reported outcomes between groups. Our results suggest that this vaginal mesh hysteropexy procedure should be made available to patients.

PMID:33716071 | DOI:10.1016/j.ajog.2021.03.012