Tag: statistics

Breast Cancer Res Treat. 2022 Oct 25. doi: 10.1007/s10549-022-06743-9. Online ahead of print.

ABSTRACT

PURPOSE: To assess whether crofelemer would prevent chemotherapy-induced diarrhea (CID) diarrhea in patients with HER2-positive, any-stage breast cancer receiving trastuzumab (H), pertuzumab (P), and a taxane (T; docetaxel or paclitaxel), with/without carboplatin (C; always combined with docetaxel rather than paclitaxel).

METHODS: Patients scheduled to receive ≥ 3 consecutive TCHP/THP cycles were randomized to crofelemer 125 mg orally twice daily during chemotherapy cycles 1 and 2 or no scheduled prophylactic medication (control). All received standard breakthrough antidiarrheal medication (BTAD) as needed. The primary endpoint was incidence of any-grade CID for ≥ 2 consecutive days. Secondary endpoints were incidence of all-grade and grade 3/4 CID by cycle/stratum; time to onset and duration of CID; stool consistency; use of BTAD; and quality of life (Functional Assessment of Chronic Illness Therapy for Patients With Diarrhea [FACIT-D] score).

RESULTS: Fifty-one patients were randomized to crofelemer (n = 26) or control (n = 25). There was no statistically significant difference between arms for the primary endpoint; however, incidence of grade ≥ 2 CID was reduced with crofelemer vs control (19.2% vs 24.0% in cycle 1; 8.0% vs 39.1%, in cycle 2). Patients receiving crofelemer were 1.8 times more likely to see their diarrhea resolved and had less frequent watery diarrhea.

CONCLUSION: Despite the choice of primary endpoint being insensitive, crofelemer reduced the incidence and severity of CID in patients with HER2-positive breast cancer receiving P-based therapy. These data are supportive of further testing of crofelemer in CID.

TRIAL REGISTRATION: Clinicaltrials.gov, NCT02910219, prospectively registered September 21, 2016.

PMID:36280642 | DOI:10.1007/s10549-022-06743-9

Eur Geriatr Med. 2022 Oct 25. doi: 10.1007/s41999-022-00695-5. Online ahead of print.

ABSTRACT

BACKGROUND: Delirium is common among older hospitalized patients and is regarded as a negative outcome parameter. Non-pharmacological strategies have been shown to be effective in the prevention and management of delirium. This study aimed to determine the effectiveness of art therapy as part of a multicomponent intervention in preventing and managing delirium in hospitalized older patients.

METHODS: 138 patients at risk of developing delirium were included and received art therapy twice daily for 25 min using a mobile atelier. 107 participants were included in the final analysis (N = 53 intervention, N = 54 control). The primary outcome was the effectiveness of art therapy in preventing delirium. The secondary outcome was to determine its impact on duration of delirium in patients with existing delirium. Delirium was assessed using the Nursing delirium Screening Scale (Nu-DESC).

RESULTS: 8 patients (7.5%) developed new onset delirium after admission, equally distributed among control and intervention group. Therefore, no valid statistical analysis could be performed. There was a statistically non-significant decrease in the duration of delirium in the intervention group (4 days, IQR 2.25-8.75) compared to the control group (7 days, IQR 5-10), Mann-Whitney-U-Test p-value = 0.26. After stratifying by dementia diagnosis on admission, the non-significant decrease in duration of delirium in the intervention group was more apparent in patients without dementia.

CONCLUSION: Findings from this study showed that the integration of art therapy as part of a multicomponent intervention in delirium management is feasible, and can reduce duration of delirium among hospitalized older adults.

PMID:36280630 | DOI:10.1007/s41999-022-00695-5

Aesthetic Plast Surg. 2022 Oct 24. doi: 10.1007/s00266-022-03115-y. Online ahead of print.

ABSTRACT

INTRODUCTION: Nipple-sparing mastectomy (NSM) is a surgical procedure increasingly performed for breast cancer or risk reduction surgeries. The site of skin incision seems to affect not only cosmesis but also technical ease in operating and vascular viability of the nipple. We present a series of patients who underwent a modified vertical surgical approach for NSM, which resulted to be safe, reliable, and with good esthetic results.

MATERIALS AND METHODS: From December 2016 to February 2019, 27 “Hook Shape” incision NSMs were performed. All patients underwent an immediate subcutaneous muscle-sparing reconstruction with tissue expander covered by a titanium-coated polypropylene mesh, followed by a second surgical step with expander substitution and lipofilling on the definitive implant when indicated. Preoperative and postoperative BREAST-Q patient-reported outcomes measure was performed in all cases.

RESULTS: Postoperative morbidity was evaluated: One patient developed seroma and another presented a systemic infection that resolved with intravenous infusion of antibiotics. One patient experienced vertical wound dehiscence, recovered after conservative treatment and without implant exposure. No implant loss was observed. Nipple-areola complex necrosis or ischemia rate was 0%. The BREAST-Q outcomes reported significant increases in the overall satisfaction with breast (p < 0.05), psychosocial well-being (p < 0.05), and sexual well-being (p < 0.05) sections. Scores in the physical impact of surgery section appeared to decline from preoperative to postoperative evaluations, with no statistically significant results.

CONCLUSION: The mastectomy incision pattern can burden the surgical challenge, impact vascular viability of the nipple and significantly affect the aesthetic outcomes in breast reconstruction. We report our experience with an alternative approach for NSM, which appears a safe, practical, and reproducible method for patients with small- to medium-sized breasts and little/medium ptosis (grade I or II).

LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

PMID:36280606 | DOI:10.1007/s00266-022-03115-y

Diagn Interv Imaging. 2022 Oct 21:S2211-5684(22)00185-1. doi: 10.1016/j.diii.2022.09.007. Online ahead of print.

NO ABSTRACT

PMID:36280585 | DOI:10.1016/j.diii.2022.09.007

Obes Res Clin Pract. 2022 Oct 21:S1871-403X(22)00113-2. doi: 10.1016/j.orcp.2022.10.007. Online ahead of print.

ABSTRACT

BACKGROUND: Maternal exposure to dibutyl phthalate (DBP) may result in obesity in female offspring. However, the underlying mechanisms remain elusive.

MATERIALS AND METHODS: Sprague-Dawley rats were intraperitoneally injected with different doses of DBP and corn oil from gestational day 7 until the end of lactation. The weights, visceral fat percentage, serum lipid, insulin and glucose, protein levels of PI3K signal pathway in muscle were detected in F1 female offspring.

RESULTS: Although the birth weight of F1 female offspring was not different among groups, the weights were heavier in DBP groups from postnatal day 7 to adult (P < 0.001). The visceral adipose percentage in adult female offspring was increased by perinatal exposure to DBP (P < 0.001). Decreased serum level of triglyceride (P = 0.001) in F1 female offspring was found in DBP group as compared to control, especially in medium and high DBP. However, none difference was found for fasting glucose, prolactin, HOMA-IR, fasting insulin, total cholesterol, adiponectin. Different protein levels of GPR30 were observed in muscle of female offspring among four groups (P = 0.016). The protein level of AKT seemed higher in DBP group but without statistical significance (P = 0.05). None difference was observed for the protein levels of PI3K, p-AKT, pAKT/AKT, PTEN, GLUT4, InsR, IRS.

CONCLUSION: Maternal perinatal exposure to DBP might induce obesity and accumulation of visceral adipose tissue for the adult female offspring. Serum glucolipid and local signal transduction of PTEN/PI3K/AKT pathway in muscle were not adversely affected by perinatal exposure to DBP for adult female offspring.

PMID:36280576 | DOI:10.1016/j.orcp.2022.10.007

Vaccine. 2022 Oct 21:S0264-410X(22)01263-4. doi: 10.1016/j.vaccine.2022.10.015. Online ahead of print.

ABSTRACT

OBJECTIVES: This study examined healthcare resource use (HCRU) for selected vaccine-preventable diseases (VPD) in secondary care in England.

METHODS: The hospital episode statistics (HES) dataset covering all secondary care interactions within the English National Health Service (NHS) from 2015 to 2021 was used to identify and track HCRU for patients with a primary or secondary diagnosis for pertussis and Haemophilus influenzae type b (Hib), or a primary diagnosis only for hepatitis B, diphtheria, poliomyelitis, or tetanus. The first documented diagnosis during the study period (01/04/2015-31/03/2021) was the index event.

RESULTS: 7,274 patients with a total of 5,554,343 patient-days (mean follow up 1,491 days) were included. The total number of hospital admissions was 27,092 and total inpatient cost was £4,987,770, with hepatitis B making up ∼80 % of this. Mean outpatient hospital appointments per patient were highest for tetanus (4.00), but total outpatient A&E cost burden was highest for Hib (£643,343 [mean per attendance £144.57]). For patients 0-9 years of age (n = 1,917), pertussis (n = 1,547) and Hib (n = 313) were by far the most commonly coded diseases. Hepatitis B was the most common disease in adults of working age and Hib was most prevalent in adults of retirement age. Surprisingly, poliomyelitis was observed in the database potentially due to historic diagnoses and/or coding inaccuracy. Other discrepancies with surveillance data were noted.

CONCLUSIONS: VPDs impose a large burden on the NHS, but there is potential to reduce this and improve public health by optimising vaccination schedules, improving access and ensuring high coverage rates.

PMID:36280563 | DOI:10.1016/j.vaccine.2022.10.015

Vaccine. 2022 Oct 20:S0264-410X(22)01282-8. doi: 10.1016/j.vaccine.2022.10.025. Online ahead of print.

ABSTRACT

BACKGROUND: Knowing the settings where children ages 5-17 years received COVID-19 vaccination in the United States, and how settings changed over time and varied by socio-demographics, is of interest for planning and implementing vaccination programs.

METHODS: Data from the National Immunization Survey-Child COVID-19 Module (NIS-CCM) were analyzed to assess place of COVID-19 vaccination among vaccinated children ages 5-17 years. Interviews from July 2021 thru May 2022 were included in the analyses for a total of n = 39,286 vaccinated children. The percentage of children receiving their COVID-19 vaccine at each type of setting was calculated overall, by sociodemographic characteristics, and by month of receipt of COVID-19 vaccine.

RESULTS: Among vaccinated children ages 5-11 years, 46.9 % were vaccinated at a medical place, 37.1 % at a pharmacy, 8.1 % at a school, 4.7 % at a mass vaccination site, and 3.2 % at some other non-medical place. Among vaccinated children ages 12-17 years, 35.1 % were vaccinated at a medical place, 47.9 % at a pharmacy, 8.3 % at a mass vaccination site, 4.8 % at a school, and 4.0 % at some other non-medical place. The place varied by time among children ages 12-17 years but minimally for children ages 5-11 years. There was variability in the place of COVID-19 vaccination by age, race/ethnicity, health insurance, urbanicity, and region.

CONCLUSION: Children ages 5-17 years predominantly received their COVID-19 vaccinations at pharmacies and medical places. The large proportion of vaccinated children receiving vaccination at pharmacies is indicative of the success in the United States of expanding the available settings where children could be vaccinated. Medical places continue to play a large role in vaccinating children, especially younger children, and should continue to stock COVID-19 vaccine to keep it available for those who are not yet vaccinated, including the newly recommended group of children < 5 years.

PMID:36280560 | DOI:10.1016/j.vaccine.2022.10.025

Nephrol Ther. 2022 Oct 21:S1769-7255(22)00528-4. doi: 10.1016/j.nephro.2022.07.397. Online ahead of print.

ABSTRACT

INTRODUCTION: Non-adherence behaviors are very common in chronic hemodialysis patients, it is estimated that only one patient out of two complies with medical prescriptions, these behaviors are associated with a higher risk of morbidity and adverse events as well as increased expenses for health systems. The aim of our study was to assess adherence to long-term prescribed medications in chronic hemodialysis patients, using a mobile application named TestObs, as well as to determine the main factors influencing medication adherence.

METHODS: We conducted a prospective descriptive study, between January and June 2019. We developed a mobile application named TestObs, downloadable on playstore for android devices, which assesses with the Girerd questionnaire, the adherence to the main medications taken by chronic hemodialysis patients. We included adult patients, with a duration of dialysis of more than 6 months, all patients who downloaded TestObs, tested their adherence to their medication by answering the questionnaire. We created a web-based platform, where data was collected from the application and then analyzed and tabulated. Regarding the statistical analysis, the normal distribution of the variables was studied by the Kolmogorov-Smirnov test, the analysis of the qualitative variables used the Pearson’s Chi² and Fisher’s statistical test, the Hosmer Lemeshow test was used to examine the quality of the final logistic regression model.

RESULTS: We collected 90 adult chronic hemodialysis patients, 51 of them (56%) were selected to enter the study. We found good compliance in 46.15% of patients, minor noncompliance in 32.87%, and noncompliance in 20.98%. In multivariate analysis, the factors influencing adherence were the presence of other comorbidities (diabetes and vision problems) and the number of pills per day.

DISCUSSION: In this study, we report treatment adherence problems in 53.85% of patients, our results are close to the data reported in hemodialysis patients in the literature, different factors influence the quality of treatment adherence, in our study poly-medication and the presence of other comorbidities were the statistically significant determinants. The new technology assessment instruments were used in hemodialysis patients and were able to provide real-time monitoring of adherence behaviors.

CONCLUSION: We believe that mobile health technologies hold promise for assessing and improving medication adherence in hemodialysis patients, so we suggest that TestObs represents an accessible and free of charge tool, based on a validated questionnaire, that can allow patients to benefit from new technologies for medical monitoring, and may eventually constitute an interventional program to improve medication adherence; however, this technological tool should not replace traditional therapeutic education; prior targeting of non-adherent patients and an optimal combination of several tools can help improve adherence in these patients.

PMID:36280551 | DOI:10.1016/j.nephro.2022.07.397

Burns. 2022 Sep 29:S0305-4179(22)00249-2. doi: 10.1016/j.burns.2022.09.010. Online ahead of print.

ABSTRACT

Our objective was to compare the outcomes of full thickness skin grafts versus split thickness skin grafts in paediatric hand burn patients. A systematic review and meta-analysis were carried out in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) Guidelines, and an electronic search was conducted to identify all Randomised Controlled Trials and non-randomised studies comparing the outcomes of full thickness skin grafts versus split thickness skin grafts in paediatric hand burn patients. Primary outcomes included development of post-graft contracture and the necessity for surgical release. Secondary outcomes consisted of evaluation of function, cosmesis and colour, scar and feeling, hair growth, and other complaints. For the analysis, fixed effects modelling was applied. Results: ten non-randomised trials with a total of 532 grafts were found. Full thickness skin grafts exhibited a statistically significant decrease in the development of post-graft contracture (Odds Ratio [OR] = 0.35, P = 0.0001) and later surgical releases (OR = 0.06, P = 0.00001). For secondary outcomes, full thickness skin grafts outperformed split thickness skin grafts in post-operative functional ability. However, split thickness skin grafts, showed to be superior in scar, aesthetic, and colour assessments, and less hair growth was observed for split thickness skin grafts. No significant difference was seen in sensation and donor or recipient site complaints. Overall, full thickness skin grafts are a better alternative for paediatric hand burns than split thickness skin transplants because they are linked with reduced post-graft contracture and the requirement for surgical release.

PMID:36280545 | DOI:10.1016/j.burns.2022.09.010

J Cyst Fibros. 2022 Oct 21:S1569-1993(22)01384-4. doi: 10.1016/j.jcf.2022.10.003. Online ahead of print.

ABSTRACT

BACKGROUND: Elexacaftor/tezacaftor/ivacaftor (ETI) improves pulmonary disease in people with cystic fibrosis (PwCF), but its effect on gastrointestinal symptoms, which also affect quality of life, is not clear.

METHODS: PROMISE is a 56-center prospective, observational study of ETI in PwCF >12 years and at least one F508del allele. Gastrointestinal symptoms, evaluated by validated questionnaires: Patient Assessment of Upper Gastrointestinal Disorders-Symptom (PAGI-SYM), Patient Assessment of Constipation-Symptom (PAC-SYM), Patient Assessment of Constipation-Quality of Life (PAC-QOL)), fecal calprotectin, steatocrit and elastase-1 were measured before and 6 months after ETI initiation. Mean difference and 95% confidence intervals were obtained from linear regression with adjustment for age and sex.

RESULTS: 438 participants fully completed at least 1 questionnaire. Mean (SD) for baseline PAGI-SYM, PAC-SYM, and PAC-QOL total scores were 0.56 (0.59), 0.47 (0.45), and 0.69 (0.53) out of maximum 5, 4, and 5, respectively (higher score indicates greater severity). Corresponding age- and sex-adjusted 6 months mean changes (95% CI) in total scores were -0.15 (-0.21, -0.09) for PAGI-SYM, -0.14 (-0.19, -0.09) for PAC-SYM, and -0.15 (-0.21, -0.10) for PAC-QOL. While statistically significant, changes were small and unlikely to be of clinical importance. Fecal calprotectin showed a change (95% CI) from baseline of -66.2 µg/g (-86.1, -46.2) at 6 months, while fecal elastase and steatocrit did not meaningfully change.

CONCLUSIONS: After 6 months of ETI, fecal markers of inflammation decreased. Gastrointestinal symptoms improved, but the effect size was small. Pancreatic insufficiency did not improve.

PMID:36280527 | DOI:10.1016/j.jcf.2022.10.003