Categories
Nevin Manimala Statistics

Bioabsorbable Implant for Treatment of Nasal Valve Collapse with or without Concomitant Procedures

Facial Plast Surg. 2021 Apr 14. doi: 10.1055/s-0041-1726464. Online ahead of print.

ABSTRACT

The aim of the study is to report outcomes after treatment of nasal valve collapse with a bioabsorbable nasal implant. It involves two prospective, multicenter, post-market studies evaluating long-term effectiveness of the LATERA implant for severe to extreme nasal obstruction. Participants underwent implant alone or with concomitant inferior turbinate reduction (ITR) and/or septoplasty. Outcome measures included the change from baseline Nasal Obstruction Symptom Evaluation (NOSE) scores, NOSE responder rates, visual analog scale (VAS) scores, and adverse events. A total cohort of 277 participants (109 implants only, 67 implants + ITR, 101 implants + septoplasty + ITR) enrolled at 19 U.S. centers was available for analysis with 177 participants (69 implants only, 39 implants + ITR, 69 implants + septoplasty + ITR) available at 2 years. The mean changes from baseline in NOSE scores and VAS scores were statistically significant (p < 0.001) at all follow-up periods. The baseline NOSE score of 77.8 ± 13.6 was improved to 24.2 ± 23.6 at 24 months. Greater than 90% of participants were NOSE responders across all follow-up periods, 6.1% withdrew for lack of treatment effect. The baseline VAS score of 66.7 ± 18.8 was improved to 21.1 ± 23.9 at 24 months. There were no serious adverse events related to the device or implant procedure. Implant retrieval rate was 4.0% (22/543 implants). Nonserious adverse events were mild to moderate in severity, typically occurred within 6 months of implant, and resolved or were stable. Significant reductions in NOSE and VAS scores and high responder rates from our large population of patients with nasal obstruction who had nasal valve implants confirm sustained effectiveness at 24 months after treatment. The studies are registered on www.clinicaltrials.gov (NCT02952313 and NCT02964312).

PMID:33853139 | DOI:10.1055/s-0041-1726464

Categories
Nevin Manimala Statistics

Uptake of an Integrated Electronic Questionnaire System in Community Pediatric Clinics

Appl Clin Inform. 2021 Mar;12(2):310-319. doi: 10.1055/s-0041-1727198. Epub 2021 Apr 14.

ABSTRACT

OBJECTIVE: The study aimed to evaluate an integrated electronic questionnaire system implementation in outpatient community pediatric practices on workflow, completion rates, and recorded scores.

METHODS: We evaluated the implementation and outcomes of an integrated electronic questionnaire system at 45 community pediatric practices that used standardized questionnaires to screen for autism, depression, and substance use and to measure asthma control. Electronic health record (EHR) data for all well child visits were extracted for the 3 months before and after implementation. We used statistical process control charts to evaluate questionnaire completion rates and Chi-square tests to evaluate screening completion and positive screening rates. The collection and entry of questionnaire information was observed and timed.

RESULTS: EHR data included 107,120 encounters across 45 practices that showed significant and sustained improvement in completion rates for all questionnaires. The rate of recorded concerning questionnaires decreased for asthma control (19.3 vs. 12.8%, p < 0.001), stayed the same for autism (96.6 vs. 96.2%, p = 0.38), decreased for depression (9.5 vs. 6.7%, p ≤ 0.001), and increased for any substance use (9.8 vs. 12.8%, p < 0.001). Twelve practices were observed, and patient time and staff time managing questionnaires were decreased after implementation.

DISCUSSION: Electronic questionnaire administration saved staff time and patient time. We report overall improvement in questionnaire completion rates, with notable variation in improvement in completion across practices and in change in concerning recorded result rates across measures.

CONCLUSION: Conversion of four standard paper questionnaires to an integrated electronic system reduces patient and staff time while increasing completion rates when well integrated into routine care.

PMID:33853141 | DOI:10.1055/s-0041-1727198

Categories
Nevin Manimala Statistics

Favorable Outcomes From an In-person and Online Feasibility Mindful Moment Pilot Study

Holist Nurs Pract. 2021 May-Jun 01;35(3):158-166. doi: 10.1097/HNP.0000000000000443.

ABSTRACT

Long hours, inadequate staff, and increasingly complicated patients make nurses more vulnerable to increased levels of stress and burnout. Nurses skilled in exercising self-care practices are better equipped to manage complex clinical situations. The purpose of this pilot study was to evaluate the feasibility of short mindfulness sessions (Mindful Moment) practiced prior to a shift, available in person and online, on nurse burnout and perceived levels of stress. The 8-week Mindful Moment study consisted of 20-minute sessions delivered either in person or online that included yoga, self-reflection, and meditation. Nurse burnout was assessed using the Maslach Burnout Inventory at weeks 0, 4, and 8. Perceived stress was assessed using a visual analog scale before and after each Mindful Moment session. Descriptive statistics, pre/postintervention differences, and percent change calculations were used to evaluate study outcomes. Forty-seven nurses agreed to participate, with 20 nurses completing the study (43%). Participants were all female, aged 36.8 ± 9.8 years, with 12 ± 8.6 years of nursing experience. With respect to nurse burnout, there was a -31% change in emotional exhaustion (P = .079), a -31% change in depersonalization (P = .057), and a +10% change in personal accomplishment (P = .331). There were consistent reductions in nurses’ perceived stress pre/post-Mindful Moment session, with percent changes ranging from -35% to 40%. Findings from this study suggest that practicing a brief Mindful Moment prior to the start of a shift is feasible and self-care interventions provide lower levels of burnout and perceived stress among this sample of nurses.

PMID:33853100 | DOI:10.1097/HNP.0000000000000443

Categories
Nevin Manimala Statistics

Establishment of Early Pregnancy Related Thyroid Hormone Models and Reference Intervals for Pregnant Women in China Based on Real World Data

Horm Metab Res. 2021 Apr;53(4):272-279. doi: 10.1055/a-1402-0290. Epub 2021 Apr 14.

ABSTRACT

Thyroid hormone reference intervals are crucial for diagnosing and monitoring thyroid dysfunction during early pregnancy, and the dynamic change trend of thyroid hormones during pregnancy can assist clinicians to assess the thyroid function of pregnant women. This study aims to establish early pregnancy related thyroid hormones models and reference intervals for pregnant women. We established two derived databases: derived database* and derived database#. Reference individuals in database* were used to establish gestational age-specific reference intervals for thyroid hormones and early pregnancy related thyroid hormones models for pregnant women. Individuals in database# were apparently healthy non-pregnant women. The thyroid hormones levels of individuals in database# were compared with that of individuals in database* using nonparametric methods and the comparative confidence interval method. The differences in thyroid stimulating hormone and free thyroxine between early pregnant and non-pregnant women were statistically significant (p<0.0001). The reference intervals of thyroid stimulating hormone, free thyroxine and free triiodothyronine for early pregnant women were 0.052-3.393 μIU/ml, 1.01-1.54 ng/dl, and 2.51-3.66 pg/ml, respectively. Results concerning thyroid stimulating hormone and free thyroxine reference intervals of early pregnancy are comparable with those from other studies using the same detection platform. Early pregnancy related thyroid hormones models showed various change patterns with gestational age for thyroid hormones. Early pregnancy related thyroid hormones models and reference intervals for pregnant women were established, so as to provide accurate and reliable reference basis for the diagnosing and monitoring of maternal thyroid disfunction in early pregnancy.

PMID:33853119 | DOI:10.1055/a-1402-0290

Categories
Nevin Manimala Statistics

Use of Single Chimeric Free Flaps or Double Free Flaps for Complex Head and Neck Reconstruction

J Reconstr Microsurg. 2021 Apr 14. doi: 10.1055/s-0041-1727188. Online ahead of print.

ABSTRACT

BACKGROUND: Free flaps have become the preferred reconstructive approach to restore form and function for patients presenting with complex head and neck defects. For composite, complex defects for which a regular free flap might not meet all reconstructive demands, adequate coverage can be achieved with either a single chimeric free flap or a double free flap.

METHODS: We performed a single-center retrospective chart review of patients who underwent either single chimeric free flap or double free flap reconstruction. Indications for reconstruction included defects resultant from head and neck tumor or osteoradionecrosis resections. We extracted the following variables: tumor location, defect, flap(s) performed, and postoperative complications. Unpaired t-tests were performed to evaluate for statistically significant differences in complications encountered between the single chimeric versus the double free flap patient groups.

RESULTS: In our series of 44 patients, a total of 55 single chimeric and double free flaps were performed. We found no significant difference in overall complications (p = 0.41) or flap/skin paddle loss (p = 0.45) between the groups. There were three total flap losses; two patients underwent successful salvage procedures and one patient died. The anterolateral thigh (ALT) was the most common free flap (70%) used in our series, and 98% of our patients completed successful reconstruction.

CONCLUSION: As the initial reconstructive effort is critical for achieving favorable long-term outcomes in complex head and neck cases, effective and safe techniques should be employed to ensure optimal delivery of care. We believe that single chimeric and double free flap techniques should be appropriately utilized as part of the armamentarium of head and neck reconstructive microsurgeons.

PMID:33853130 | DOI:10.1055/s-0041-1727188

Categories
Nevin Manimala Statistics

MAP17 Expression in Colorectal Cancer Is a Prognostic Factor for Disease Recurrence and Dismal Prognosis Already in Early Stage Disease

Oncology. 2021 Apr 14:1-11. doi: 10.1159/000515596. Online ahead of print.

ABSTRACT

BACKGROUND: Disease recurrence in colorectal cancer constitutes a major cause of significant cancer-associated morbidity and mortality. MAP17 is a small protein, and its overexpression in malignant tumors has been correlated with aggressive tumor phenotypes. The aim of the present study was to investigate the expression patterns of MAP17 in colorectal cancer specimens and to assess its clinical significance.

PATIENTS AND METHODS: Surgical specimens of 111 patients with primary resectable colorectal cancer constituted the study population. Expression of MAP17 was assessed by immunohistochemistry, and the results were correlated with clinical and survival data.

RESULTS: MAP17 was expressed in cancer cells and endothelial cells of tumor blood vessels. Expression of MAP17 more than 10% was correlated with advanced disease stage (p < 0.001), higher T classification (p = 0.007), the presence of lymph node metastasis (p < 0.001), vascular (p = 0.013) and perineural invasion (p = 0.012). Patients exhibiting MAP17 expression of more than 30% in cancer cells compared to those expressing MAP17 less than 10% demonstrated a significantly worse 3-year progression-free survival (35.2 vs. 91%, p < 0.001) and 5-year overall survival (40.8 vs. 91%, p < 0.001). Cox regression analysis confirmed MAP17 expression of more than 30% as a prognostic marker of progression free survival (HR 0.136, 95% CI = 0.056-0.329, p < 0.001) and overall survival (HR 0.144 [95% CI) = 0.049-0.419, p < 0.001) independent of other clinicopathological characteristics. Statistically significantly worse 3-year progression-free survival and 5-year overall survival was demonstrated in the subgroup analysis of patients with early stage cancer only and high expression of MAP17.

CONCLUSIONS: High MAP17 expression in patients with colorectal cancer is a significant risk factor for cancer-associated morbidity and mortality already in early stage disease.

PMID:33853080 | DOI:10.1159/000515596

Categories
Nevin Manimala Statistics

The Prevalence of Complementary and Integrative Health Approach Use and Quality of Life Among Patients With Heart Failure: A Cross-sectional, Descriptive, and Comparative Study

Holist Nurs Pract. 2021 May-Jun 01;35(3):123-132. doi: 10.1097/HNP.0000000000000442.

ABSTRACT

This study aimed to determine the prevalence of complementary and integrative health approach (CIHA) use in patients with heart failure (HF) and compare quality of life (QoL) between CIHA users and nonusers. This was a cross-sectional, descriptive, and comparative study including 130 patients with HF in Turkey. The data were collected using the sociodemographic and CIHA information form and the Kansas City Cardiomyopathy Questionnaire (KCCQ). The mean age was 64.51 ± 10.40 years. Furthermore, 26.1% of the participants had used at least one form of CIHA in the previous year. The most used CIHA was herbal therapies (94.2%). The total scores of the KCCQ were 47.70 ± 9.50 in the study, and a statistically significant difference was found in the total scores of the KCCQ between CIHA users and nonusers. The findings of this study revealed that more than a quartile of patients with HF used at least one form of CIHA. Further prospective studies are warranted to follow up with patients having HF who use any form of CIHA for a longer period and determine other parameters that directly influence QoL.

PMID:33853096 | DOI:10.1097/HNP.0000000000000442

Categories
Nevin Manimala Statistics

Effect of Music on Fatigue, Comfort, and Vital Signs in Patients After Liver Transplant Surgery: A Randomized Controlled Trial

Holist Nurs Pract. 2021 May-Jun 01;35(3):150-157. doi: 10.1097/HNP.0000000000000444.

ABSTRACT

This randomized controlled clinical trial was conducted to determine the effect of music therapy on fatigue, comfort and vital signs of the liver transplant patients. The study sample comprised 120 adult patients (60 in the experimental and 60 in the control group) who met the inclusion criteria and agreed to participate in the study. In the experimental group, the researcher performed music therapy. After applying music therapy once to patients for 30 minutes, their fatigue, comfort, and vital signs were evaluated. No treatment was performed in the control group. According to music therapy follow-ups after liver transplantation, mean scores of fatigue levels were lower, comfort levels were higher, and vital signs were normal, with a statistical significance in the experimental group compared with the control group in all measurements before and after music therapy (P < .001). The study should be repeated using different parameters.

PMID:33853099 | DOI:10.1097/HNP.0000000000000444

Categories
Nevin Manimala Statistics

Enhanced Recovery after Surgery: Benefits for the Fetal Surgery Patient

Fetal Diagn Ther. 2021 Apr 14:1-8. doi: 10.1159/000515550. Online ahead of print.

ABSTRACT

BACKGROUND: The fetoscopic approach to the prenatal closure of a neural tube defect (NTD) may offer similar advantages to the newborn compared to prenatal open closure of a NTD, with a reduction in maternal risks. Enhanced recovery after surgery (ERAS) protocols have been applied to different surgical procedures with documented advantages. We modified the perioperative care of patients undergoing in utero repair of myelomeningocele with the goal of enhancing the recovery. A retrospective study comparing traditional management to the ERAS protocol was conducted.

AIMS: Primary aim was to evaluate the length of stay (LOS). Secondary outcomes included pain scores, time to oral intake, opioid-induced side effects, and respiratory complications.

METHODS: Thirty patients who underwent a mid-gestation fetoscopic closure of a NTD were included. Data analyzed include demographics, comorbidities, LOS, anatomical location of the NTD, magnesium sulfate doses and duration of administration, oxygen requirements, duration of the postoperative epidural infusion, duration of surgery and anesthesia, incidence of postoperative nausea and vomiting, respiratory complications, time to oral intake, pain scores, and sedation scores. Differences between the treatment groups were compared using the independent sample t-test or Mann-Whitney Ʋ test.

RESULTS: Of the 30 patients, 10 patients were managed according to the ERAS protocol and 20 patients according to the traditional management (1:2 ratio). The mean gestational age at the time of intervention for the traditional and ERAS groups was 24.9 ± 0.5 weeks and 24.8 ± 0.5 weeks, respectively. Compared to the traditional group, the LOS was reduced in the ERAS group to 112.5 ± 12.6 h (4.7 ± 0.5 days) from 179.7 ± 87.9 h (7.5 ± 3.7 days) (p = 0.012). The time to oral intake was also shorter 502.6 ± 473.4 min versus 1015.6 ± 698.2 min; p = 0.049. Oxygen requirements were prolonged in the traditional group (1843.7 ± 1262.6 min vs. 1051.7 ± 1078.1 min p = 0.052). The total duration of magnesium sulfate was longer for patients in the traditional group (2125.6 ± 727.1 min vs. 1429.5 ± 553.8 min; p = 0.006). No statistically significant difference in pain scores was observed between the groups.

CONCLUSIONS: Establishing an ERAS protocol for fetoscopic in utero repair of NTDs approach is feasible with the advantages of decreased postoperative LOS, reduced oxygen requirements, lower duration of magnesium sulfate infusion, and facilitation of earlier oral intake without compromising the pain scores.

PMID:33853070 | DOI:10.1159/000515550

Categories
Nevin Manimala Statistics

Statistical inference for the difference between two maximized Youden indices obtained from correlated biomarkers

Biom J. 2021 Apr 14. doi: 10.1002/bimj.202000128. Online ahead of print.

ABSTRACT

Currently, there is global interest in deriving new promising cancer biomarkers that could complement or substitute the conventional ones. Clinical decisions can often be based on the cutoff that corresponds to the maximized Youden index when maximum accuracy drives decisions. When more than one classification criteria are measured within the same individuals, correlated measurements arise. In this work, we propose hypothesis tests and confidence intervals for the comparison of two correlated receiver operating characteristic (ROC) curves in terms of their corresponding maximized Youden indices. We explore delta-based techniques under parametric assumptions, or power transformations. Nonparametric kernel-based methods are also examined. We evaluate our approaches through simulations and illustrate them using data from a metabolomic study referring to the detection of pancreatic cancer.

PMID:33852754 | DOI:10.1002/bimj.202000128