Category: Statistics

Retina. 2021 Sep 23. doi: 10.1097/IAE.0000000000003309. Online ahead of print.

ABSTRACT

PURPOSE: To determine the relationship between macular microvascular abnormalities on optical coherence tomography angiography (OCT-A) and silent cerebral infarctions (SCI) on cerebral magnetic resonance imaging (MRI) in sickle cell disease (SCD).

METHODS: Patients (age < 18 years old) from our previous pediatric SCD study cohort who had prior OCT-A and brain MRI were identified. Brain MRI images were compared to macular OCT-A scans to identify macular vascular density differences between patients with SCI and without SCI.

RESULTS: 68 eyes from 34 patients who underwent OCT-A were evaluated, of whom 28 eyes from 14 patients met inclusion criteria for this study. Eight (57%) patients with SCI and 6 (43%) patients without SCI were identified. The mean age (17 years in SCI, 16.3 years in non-SCI) was comparable between groups. There was no statistically significant difference in systemic complications. Deep capillary plexus (DCP) vessel density was lower in the temporal quadrant in patients with SCI (49.3% vs 53.7%, P = 0.014).

CONCLUSION: Patients with SCI were found to have lower vessel density in the DCP compared to those without SCI. This finding suggests that DCP vessel density may have utility as an imaging biomarker to predict the presence of SCI.

PMID:34608107 | DOI:10.1097/IAE.0000000000003309

Dermatol Surg. 2021 Sep 30. doi: 10.1097/DSS.0000000000003238. Online ahead of print.

ABSTRACT

BACKGROUND: The perioral region is highly mobile and subject to multifactorial changes during aging. Resilient Hyaluronic Acid Redensity (RHAR), an RHA filler, was developed with the aim of optimizing outcomes in dynamic facial areas.

OBJECTIVE: This randomized, blinded, multicenter clinical study aimed to demonstrate superiority of RHAR over no-treatment control for correction of moderate-to-severe dynamic perioral rhytides.

MATERIALS AND METHODS: Blinded live evaluator assessments of efficacy included improvement in perioral rhytides severity using a proprietary scale (Perioral Rhytids Severity Rating Scale [PR-SRS]) and the Global Aesthetic Improvement Scale. Subjects self-assessed their results with FACE-Q, a validated patient-reported outcome measure, and satisfaction scales. Safety was monitored throughout the study based on common treatment responses (CTRs) and adverse events (AEs).

RESULTS: The primary efficacy end point was achieved, with the treatment group showing statistically significant superiority over the control group at Week 8 (80.7% vs 7.8% responder rate by PR-SRS, p < .0001). Most patients (66%) were still responders at Week 52 (study completion). Most AEs were CTRs after perioral injection of a dermal filler, and none was a clinically significant treatment-related AE.

CONCLUSION: Resilient Hyaluronic Acid Redensity is effective and safe for the correction of dynamic perioral rhytides in all Fitzpatrick phototypes, with marked durability.

PMID:34608092 | DOI:10.1097/DSS.0000000000003238

Dermatol Surg. 2021 Sep 30. doi: 10.1097/DSS.0000000000003251. Online ahead of print.

ABSTRACT

BACKGROUND: Bibliometric studies provide a quantitative statistical analysis of the published literature within a field of interest and allow for easy identification of the major contributing authors, funding sources, and publication trends within the field. To date, no bibliometric studies have been performed pertaining to Merkel cell carcinoma (MCC).

OBJECTIVE: To identify the 100 most frequently cited articles in MCC through a bibliometric analysis of the literature.

METHODS: Web of science was queried to determine the 100 most frequently cited MCC publications published between the years 1970 and 2019. Articles were listed by title, authors and their affiliated institutions, journal title and type, year of publication, country of origin, funding sources, and citation frequency.

RESULTS: Among the 100 most frequently cited MCC publications, articles were cited between 67 and 589 times with a mean of 136.3 times. Articles were cited between 2.0 and 98.2 times per year since publication with a mean of 11.3 times per year. 67% of the articles were published in oncology journals; 33% and 10% of the articles in dermatology and surgery journals, respectively. The most represented journal was Cancer (12%). Paul Nghiem was the most frequently identified author (18%). 36% of the top 100 articles were published out of the University of Washington. The most frequent funding agency was the National Institutes of Health (77%).

CONCLUSION: Through this bibliometric analysis, researchers can easily identify key publications pertaining to MCC, which may in turn enhance their approach to understanding and practicing evidence-based medicine regarding MCC.

PMID:34608096 | DOI:10.1097/DSS.0000000000003251

Asia Pac J Ophthalmol (Phila). 2021 Sep 28. doi: 10.1097/APO.0000000000000439. Online ahead of print.

ABSTRACT

PURPOSE: This study compared the extended depth of focus (EDOF) intraocular lens (IOL) (ZXR00; Tecnis Symfony, Johnson & Johnson Vision, Santa Ana, CA, US) to a novel, higher-order aspheric monofocal IOL (ICB00; Tecnis Eyhance, Johnson & Johnson Vision, Santa Ana, CA, US) which uses the same platform and material.

METHODS: Medical records of patients undergoing cataract surgery with ZXR00 or ICB00 implantation between March 2020 and January 2021 and with the data available for the 3-month visit were reviewed. The uncorrected near, intermediate, and distance visual acuity (VA); corrected distance VA; and optical quality parameters were the main outcome measures.

RESULTS: Among the 174 enrolled patients, 72 and 102 received the ZXR00 and ICB00, respectively. The average patient ages were 59.6 ± 10.6 (range: 49 to 70) and 65.2 ± 8.2 (range: 45 to 82) years in the ZXR00 and ICB00 groups, respectively, with significantly older patients in the ICB00 group. The other baseline parameters were not different for the 2 groups. Compared to the ICB00 group, the ZXR00 group showed markedly superior near VA (P < 0.05) at 3 months postoperatively. In terms of optical quality, ICB00 was, statistically, significantly superior to ZXR00.

CONCLUSIONS: The ZXR00 showed remarkable near vision and defocus curve smoothness, while the ICB00 achieved better optical quality. The 2 IOLs had comparable distance and intermediate vision.

PMID:34608065 | DOI:10.1097/APO.0000000000000439

Cancer Nurs. 2021 Oct 1. doi: 10.1097/NCC.0000000000001014. Online ahead of print.

ABSTRACT

BACKGROUND: Preparedness for caregiving could balance the negative impacts of caregiving. The interventions aimed at increasing readiness among the caregivers are important during the illness period for both patients and their caregivers.

OBJECTIVES: The aims of this study were to review the interventions applied to the caregivers of cancer patients and to examine the effects of these interventions on the preparedness to care.

METHODS: The ScienceDirect, Scopus, CENTRAL, Web of Science, MEDLINE, and PubMed were searched for relevant studies published between 2000 and 2020. The methodological quality was assessed using the Quality Assessment Tool for Quantitative Studies. The statistical analyses were performed using the Comprehensive Meta-Analysis software version 3.0. The publication bias was assessed using the Egger test, for funnel plots.

RESULTS: Eleven studies were selected for the meta-analysis, including those about psychoeducation programs (n = 5), education programs (n = 3), supportive programs (n = 2), and a self-care support program for the caregivers (n = 1). The methodological quality assessment revealed 2 studies as “strong.” The results indicated an increase in the caregivers’ preparedness to care after the interventions. The subgroup analysis revealed that the programs with higher ratios of female caregivers were more effective.

CONCLUSION: The interventions applied to the family caregivers can exert beneficial effects on caregivers’ preparedness to care. Nonetheless, future studies should focus on methodological issues, such as randomization and blinding.

IMPLICATIONS FOR PRACTICE: Nurse-driven interventions may be used as a useful strategy to improve the preparedness to care among the caregivers of cancer patients. The male caregivers should be closely followed by healthcare professionals for knowledge and support needs.

PMID:34608043 | DOI:10.1097/NCC.0000000000001014

Cancer Nurs. 2021 Sep 30. doi: 10.1097/NCC.0000000000001012. Online ahead of print.

ABSTRACT

BACKGROUND: Complex survivorship cancer care requires nurse-led interventions. Therefore, a nurse-led patient navigation intervention was developed in which trained cancer nurses gave advice and referred to other professionals during the process of recovery and rehabilitation of hematopoietic stem cell transplantation (HSCT) patients.

OBJECTIVE: The aim of this study was to understand the nature and effect of this nurse-led information and referral intervention.

METHODS: Of the 199 included patients in the intervention group, 75 completed the quality of life, quality of care, self-efficacy, and self-management behavior questionnaires at baseline and at 6 and 12 months after HSCT. A historical control group of 62 patients completed the same questionnaires 12 months after HSCT. In addition, patients’ experiences with the intervention were evaluated in 2 focus groups.

RESULTS: Patients emphasized the holistic approach of the cancer nurses and the opportunity to discuss psychosocial domains of life. Within the intervention group, a statistically significant effect on quality of life was demonstrated over time. The differences in quality of life, self-efficacy, and self-management were not significant between the intervention group and control group.

CONCLUSION: The holistic focus of this nurse-led intervention proved to be acceptable to the HSCT patients and promising in supporting the (complex) challenges that these patients face during their process of recovery and rehabilitation.

IMPLICATIONS FOR PRACTICE: Nurse-led patient navigation interventions with a holistic approach when included in the daily practice of complex survivorship cancer care can support HSCT patients’ information and referral needs during their rehabilitation.

PMID:34608045 | DOI:10.1097/NCC.0000000000001012

Cancer Nurs. 2021 Sep 30. doi: 10.1097/NCC.0000000000001027. Online ahead of print.

ABSTRACT

BACKGROUND: Glioblastoma multiforme (GBM) is an aggressive brain tumor. Patients commonly rely on family caregivers for physical and emotional support. We previously demonstrated that caregiver mastery measured shortly after diagnosis was predictive of GBM patient survival, corrected for known predictors of survival (n = 88).

OBJECTIVE: The aims of this study were to verify the contribution of caregiver mastery and investigate the added value of mastery over other predictors to predict 15-month survival.

METHODS: Data collected for a longitudinal study (NCT02058745) were used. Multivariable Cox regression analyses were performed for models with known clinical predictors (patient age, Karnofsky Performance Status, type of surgery, O6-methylguanine-DNA-methyltransferase promotor methylation status), with and without adding caregiver mastery to predict mortality. The added value of each model in discriminating between patients with the lowest and highest chances of survival at 15 months was investigated through Harrell’s concordance index.

RESULTS: In total, 41 caregiver-patient dyads were included. When evaluating solely clinical predictors, Karnofsky Performance Status and patient age were significant predictors of mortality (hazard ratio [HR], 0.974; 95% confidence interval [CI], 0.949-1.000; and HR, 1.045; 95% CI, 1.002-1.091, respectively). Adding caregiver mastery, these clinical predictors remained statistically significant, and mastery showed an HR of 0.843 (95% CI, 0.755-0.940). The discriminative value improved from C = 0.641 (model with known clinical predictors) to C = 0.778 (model with mastery), indicating the latter is superior.

CONCLUSIONS: We confirm that caregiver mastery is associated with GBM patient survival.

IMPLICATIONS FOR PRACTICE: Incorporating support and guidance for caregivers into standard care could lead to benefits for caregiver well-being and patient outcomes.

PMID:34608049 | DOI:10.1097/NCC.0000000000001027

Female Pelvic Med Reconstr Surg. 2021 Sep 30. doi: 10.1097/SPV.0000000000001036. Online ahead of print.

ABSTRACT

OBJECTIVES: The primary objective of this study was to compare optimal response (“very much better” or “much better” on the Patient Global Impression of Improvement [PGI-I] index) to posterior tibial nerve stimulation (PTNS) for overactive bladder (OAB) in patients with and without diabetes mellitus. Secondary outcomes included longitudinal data regarding PTNS use in patients with diabetes and controls.

METHODS: We performed a retrospective cohort analysis of women in our tertiary care center who completed at least 10 weekly and 1 maintenance PTNS treatments for OAB, excluding patients who were treated with PTNS for a non-OAB primary diagnosis. Participants were grouped into those with diabetes mellitus and those without. Previous research demonstrated a 20% difference in subjective response to anticholinergics in persons with diabetes versus persons without diabetes with OAB. To demonstrate a 20% difference in optimal PGI-I with 80% power, our analysis required 92 patients in each group.

RESULTS: We identified 356 patients: 96 with diabetes mellitus, and 260 controls. There was no statistically significant difference in the primary outcome, with 43 (44.8%) of 96 persons with diabetes versus 115 (44.2%) of 260 controls demonstrating optimal PGI-I response (P = 0.92). Among patients with diabetes, no baseline variables were found to predict treatment response, including hemoglobin A1C greater than 7%, diabetes with sequelae, or higher Charlson Comorbidity Index.

CONCLUSIONS: In women undergoing PTNS for OAB, the optimal PGI-I response rate is similar in patients with and without diabetes.

PMID:34608031 | DOI:10.1097/SPV.0000000000001036

Female Pelvic Med Reconstr Surg. 2021 Sep 30. doi: 10.1097/SPV.0000000000001099. Online ahead of print.

ABSTRACT

OBJECTIVES: There does not currently exist a complication scale to evaluate pelvic reconstructive surgery (PRS) that takes in account patient-centered outcomes. The purpose of this study was to characterize and compare patient and surgeon responses to a simplified, patient-centered version of the previously described Pelvic Floor Complication Scale (PFCS).

METHODS: This is a multicenter (4 female pelvic medicine and reconstructive surgery practices) cross-sectional study of patients and surgeons. Using focus groups and telephone surveys, the original PFCS questionnaire was simplified. One hundred and twenty-four patients were recruited 6-12 months after PRS. Fifty-seven surgeons were recruited via electronic questionnaires. Surgeons and patients were asked to rank the severity and bother of each complication on a scale of 0 to 5 (0, none; 1, mild; 3, moderate; 5, major).

RESULTS: Patients rated bother higher than severity for 36 of 38 complications (all differences ≤0.5 points). For statistical analysis, the highest response to patient bother/severity was chosen to weigh in favor of the patient. Patient bother/severity scores were significantly different (±0.5 points) for 27 of 38 complications compared with surgeon responses. Surgeon scores were higher for 5 complications (0.5-1.9 point differences) related to major injury requiring repair and wound breakdown. Patient scores were higher for 22 complications with the highest differences related to dyspareunia, constipation, or new/persistent urinary incontinence.

CONCLUSIONS: This mixed methods investigation revealed key differences between how patients and surgeons value PRS complications. Surgeons scored major surgical injuries higher than patients, whereas patients rated issues that many surgeons consider quality-of-life outcomes higher due to potential long-term bother. These data will be used to create a simplified, patient-centered PFCS.

PMID:34608035 | DOI:10.1097/SPV.0000000000001099

Eye Contact Lens. 2021 Sep 29. doi: 10.1097/ICL.0000000000000846. Online ahead of print.

ABSTRACT

OBJECTIVES: The purpose of this study was to identify patients with glaucoma and corneal/ocular surface disease who have been fit with Prosthetic Replacement of the Ocular Surface Ecosystem (PROSE; BostonSight, Needham, MA) devices and to understand the PROSE device fit experience in patients with glaucoma at Weill Cornell Medicine (WCM).

METHODS: This is a retrospective chart review of patients older than 18 years who underwent PROSE device fitting at WCM. Records were reviewed for demographic information and ophthalmic variables. Descriptive statistics were performed.

RESULTS: Between 2011 and 2017, 281 patients underwent PROSE device fitting at WCM, of whom 24 patients (8.5%) had a glaucoma diagnosis and 17 patients (6.0%) were identified as glaucoma suspect. Ocular surface disease was the most common indication for PROSE device wear (58.3%). Five patients had a history of incisional glaucoma surgery in the eye undergoing PROSE device fitting: three valved glaucoma drainage implants and two trabeculectomies. Three of these eyes were successfully fit with PROSE devices.

CONCLUSIONS: Patients fitted with Prosthetic Replacement of the Ocular Surface Ecosystem devices at WCM had a higher prevalence of glaucoma than in the general population. Among patients with incisional glaucoma surgery, PROSE device fitting was challenging, with a 40% failure rate.

PMID:34608029 | DOI:10.1097/ICL.0000000000000846