Tag: pubmed

Qual Life Res. 2022 Nov 19. doi: 10.1007/s11136-022-03286-w. Online ahead of print.

ABSTRACT

PURPOSE: Treatment benefit as assessed using clinical outcome assessments (COAs), is a key endpoint in many clinical trials at both the individual and group level. Anchor-based methods can aid interpretation of COA change scores beyond statistical significance, and help derive a meaningful change threshold (MCT). However, evidence-based guidance on the selection of appropriately related anchors is lacking.

METHODS: A simulation was conducted which varied sample size, change score variability and anchor correlation strength to assess the impact of these variables on recovering the simulated MCT for interpreting individual and group-level results. To assess MCTs derived at the individual-level (i.e. responder definitions; RDs), Receiver Operating Characteristic (ROC) curves and Predictive Modelling (PM) analyses were conducted. To assess MCTs for interpreting change at the group-level, the mean change method was conducted.

RESULTS: Sample sizes, change score variability and magnitude of anchor correlation affected accuracy of the estimated MCT. For individual-level RDs, ROC curves were less accurate than PM methods at recovering the true MCT. For both methods, smaller samples led to higher variability in the returned MCT, but higher variability still using ROC. Anchors with weaker correlations with COA change scores had increased variability in the estimated MCT. An anchor correlation of around 0.50-0.60 identified a true MCT cut-point under certain conditions using ROC. However, anchor correlations as low as 0.30 were appropriate when using PM under certain conditions. For interpreting group-level results, the MCT derived using the mean change method was consistently underestimated regardless of the anchor correlation.

CONCLUSION: Sample size and change score variability influence the necessary anchor correlation strength when recovering individual-level RDs. Often, this needs to be higher than the commonly accepted threshold of 0.30. Stronger correlations than 0.30 are required when using the mean change method. Results can assist researchers selecting and assessing the quality of anchors.

PMID:36401757 | DOI:10.1007/s11136-022-03286-w

Clin Exp Med. 2022 Nov 19. doi: 10.1007/s10238-022-00946-6. Online ahead of print.

ABSTRACT

Immunotherapy is the main standard treatment for non-small cell lung cancer (NSCLC) patients. Immune suppressive cells in tumor microenvironment can counteract its efficacy. Myeloid-derived suppressor cells (MDSCs) include two major subsets: polymorphonuclear (PMN-MDSCs) and monocytic (M-MDSCs). Many studies explored the prognostic impact of these cell populations in NSCLC patients. The aim of this systematic review is to select studies for a meta-analysis, which compares prognosis between patients with high vs low circulating MDSC levels. We collected hazard ratios (HRs) and relative 95% confidence intervals (CIs) in terms of progression-free survival (PFS) or recurrence-free survival (RFS), and overall survival (OS). Among 139 studies retrieved from literature search, 14 eligible studies (905 NSCLC patients) met inclusion criteria. Low circulating MDSC levels favor a better PFS/RFS (HR = 1.84; 95% CI = 1.28-2.65) and OS (HR = 1.78; 95% CI = 1.29-2.46). The subgroup analysis based on MDSC subtypes (total-, PMN-, and M-MDSCs) obtained a statistical significance only for M-MDSCs, both in terms of PFS/RFS (HR = 2.67; 95% CI = 2.04-3.50) and OS (HR = 2.10; 95% CI = 1.61-2.75). NSCLC patients bearing high M-MDSC levels in peripheral blood experience a worse prognosis than those with low levels, both in terms of PFS/RFS and OS. This finding suggests that detecting and targeting this MDSC subset could help to improve NSCLC treatment efficacy.

PMID:36401744 | DOI:10.1007/s10238-022-00946-6

Int J Clin Oncol. 2022 Nov 19. doi: 10.1007/s10147-022-02267-w. Online ahead of print.

ABSTRACT

BACKGROUND: The risk of survivors developing a secondary bone sarcoma after being treated for pediatric cancers is well established. The aim of this study was to examine the clinical characteristics and outcomes of patients with secondary osteosarcoma (SOS).

METHODS: The study concerns survivors of childhood and adolescence primary neoplasms (PN) treated with chemotherapy, with or without radiotherapy and surgery, subsequently diagnosed with SOS.

RESULTS: We identified 26 patients (13 females, 13 males) who developed SOS a median 7.3 years after being diagnosed with a PN (5/7 of these patients tested for Li-Fraumeni and found positive for the syndrome). The sample’s median age was 8.0 and 15.0 years when their PN and SOS were diagnosed, respectively. To treat their PN, 24 out of 26 patients had been given radiotherapy, and 19 had received chemotherapy including doxorubicin. A considerable number of SOS occurred at unfavorable sites (nine hip bone, six skull). All but one patient received chemotherapy with tailored schedules, omitting doxorubicin in 19 cases. Eighteen of the 26 patients underwent surgery. The 5- and 10-year overall survival and probabilities after the diagnosis of SOS (95% confidence interval) were 50% (32.7-76.5%) and 38.9% (22.4-67.4%); 5- and 10-year progression-free survival was 47% (29.9-73.7%) and 35.2% (19.3-64.4%), respectively.

CONCLUSIONS: The survival rates after SOS are lower than in patients with primary osteosarcoma, but not negligible. It is therefore mandatory to discuss the best choice of treatment for such patients at a referral center, in terms of their chances of cure and quality of life.

PMID:36401730 | DOI:10.1007/s10147-022-02267-w

Appl Biochem Biotechnol. 2022 Nov 19. doi: 10.1007/s12010-022-04227-6. Online ahead of print.

ABSTRACT

Cervical cancer (CC), although being a potentially avoidable disease, is the second most often diagnose gynecological cancer, with at minimum 530,000 new instant reported each year, and optimism for CC remains poor. Nearly half of individuals with locally advanced cervical cancer have a poor pathological response to standard therapy. As a result, research into the molecular pathogenesis of cervical cancer and associated therapeutic targets is a must. MicroRNAs (miRNAs) are possible biomarkers in cervical cancer; elevations or reductions in many distinct miRNAs discovered in individuals with this illness indicate that miRNA could contain a function to play in the illness’s pathogenesis. Nevertheless, little is known about their significance in detecting individuals who do not respond to traditional therapy. As a consequence, the intention of this study is to look at the relationship among the synthesis of miRNAs (miR 217 and miR-140-3p), which can be utilized as molecular biomarkers to predict pathological responses in cervical cancer patients after radiation and chemotherapy. Various analytical techniques were used to analyze the data, including quantitative real-time PCR (qRT-PCR), growth and apoptosis analysis, western blot analysis, luciferase reporter gene analysis, immunohistochemistry, and statistical analysis. The results show that such miRNAs participate a crucial responsibility in CC cell proliferation inhibition. They might be a new therapeutic target for microRNA-mediated cell proliferation inhibition in cervical cancer.

PMID:36401723 | DOI:10.1007/s12010-022-04227-6

Intern Emerg Med. 2022 Nov 19. doi: 10.1007/s11739-022-03142-2. Online ahead of print.

ABSTRACT

Cardiac surgery in Jehovah’s Witnesses (JW) patients who refuse blood transfusion is challenging requiring dedicated strategies. We aimed to analyze non-selected JW patients undergoing cardiac surgery and to compare with matched controls both perioperative outcomes and long-term survival. We retrospectively analyzed JW patients undergoing cardiac surgery from January 2016 to March 2021 and compared them with matched controls. The primary outcome was a composite of in-hospital perioperative adverse events and in-hospital mortality. The secondary outcome was all-cause mortality at long-term follow-up. A total of 113 JW patients and 113 controls were included. Baseline clinical characteristics, including laboratory parameters were comparable. Overall, there were no statistical differences between JW vs controls in terms of in-hospital mortality (2.7% vs 1.8%, p = 1.00) but mortality was remarkably high (40%) in JW patients with post-op hemoglobin < 8 g/dl. Logistic regression analysis found that the JW group was not associated with a higher occurrence of the composite outcome (adjusted odds ratio 0.91, 95% confidence interval [CI] 0.54-1.57). After a median follow-up of 1397 [IQR 922.7-1723.5] days, JW patients were not associated with a significantly higher all-cause mortality (adjusted hazard ratio 0.77, 95% CI 0.24-2.42). Cardiac surgery can be safely performed in non-anemic JW patients despite the refusal of blood transfusions. Favorable clinical outcomes can be achieved by the use of specific perioperative strategies for bloodless surgery with no differences as compared to control patients except in JW patients with a very low level of post-operative hemoglobin not supported by immediate transfusions.

PMID:36401716 | DOI:10.1007/s11739-022-03142-2

Environ Monit Assess. 2022 Nov 19;195(1):126. doi: 10.1007/s10661-022-10568-w.

ABSTRACT

The current study focused on the monitoring of pollution loads in the Kalpakkam coastal zone of India in terms of physico-chemical characteristics of sediment. The investigation took place at 12 sampling points around the Kalpakkam coastal zone for one year beginning from 2019. The seasonal change of nutrients in the sediment, such as nitrogen, phosphorus, potassium, total organic carbon, and particles size distribution, was calculated. Throughout the study period, the pH (7.55 to 8.99), EC (0.99 to 4.98 dS/m), nitrogen (21.74 to 58.12 kg/ha), phosphorus (7.5 to 12.9 kg/ha), potassium (218 to 399 kg/ha), total organic carbon (0.11 to 0.88%), and particle size cumulative percent of sediments (from 9.01 to 9.39%) was observed. A number of multivariate statistical techniques were used to examine the changes in sediment quality. The population means were substantially different according to the three-way ANOVA test at the 0.05 level. Principal component analysis and cluster analysis showed a substantial association with all indicators throughout all seasons, implying contamination from both natural and anthropogenic causes. The ecosystem of the Kalpakkam coastal zone has been affected by nutrient contamination.

PMID:36401680 | DOI:10.1007/s10661-022-10568-w

J Assist Reprod Genet. 2022 Nov 19. doi: 10.1007/s10815-022-02659-x. Online ahead of print.

ABSTRACT

PURPOSE: To explore perceptions towards embryo disposition among patients donating excess embryos to a research biobank.

METHODS: Cross-sectional study of survey responses collected as part of enrollment in a research biobank. Patients are asked questions regarding the difficulty of their disposition decision, their alternative disposition choice if donation to research was not available, quality of the counseling they received, and if additional counseling throughout their treatment would have been beneficial. Survey responses use 5-point Likert scales, with “1” being lowest/least and “5” being highest/most.

RESULTS: A total of 157 men and 163 women enrolled in the biobank. Median scores for difficulty of disposition decision were 3 for females and 2 for males, and for quality of counseling, the median scores were 4 for females and 3 for males. Seventy percent of patients would have chosen to discard their excess embryos had donation to research not been an option. Statistical analyses showed no significant difference in responses based on variations in race, religion, sexual orientation, and infertility diagnoses. Concordance of responses within heterosexual couples was tested and found to be poor to moderate.

CONCLUSIONS: Assessing patients’ perceptions towards embryo disposition after donation of their excess embryos to a research biobank affords a unique perspective. The difficulty of the disposition decision, the tendency to discard embryos in the absence of a means for donation to research, and the poor agreement between heterosexual partners highlight the importance of donation to research as an accessible disposition option and the need for a personalized approach to counseling and consenting for embryo disposition.

PMID:36401676 | DOI:10.1007/s10815-022-02659-x

Parasitol Res. 2022 Nov 19. doi: 10.1007/s00436-022-07730-1. Online ahead of print.

ABSTRACT

Because the number of wild raccoons in Germany is increasing constantly, it appears to be economic reasonable to use their meat as food. For this purpose, it is essential to generate data regarding the pathogen load of the meat to be consumed and handled. It is known that raccoons, particularly in Germany, show a high seroprevalence of Toxoplasma gondii. Because serological data only indicates contact of a host to a parasite additional direct detection is needed to prove presence of parasitic stages in particular tissues. Therefore, a total of 150 samples from raccoons with known serostatus were tested and quantified using magnetic-capture real-time PCR for Toxoplasma gondii. As it represents potentially consumption-relevant parts of raccoons, meat from forelimb and hindlimb was examined. Samples were stratified into three groups based on the animals’ serostatus (each 50 negative, low positive, and high positive). All samples from seronegative animals were found negative by MC-PCR as well. In a total of 56 meat samples from 100 seropositive animals, T. gondii DNA was detected. Statistically significant more samples were positive by MC-PCR in the high positive than in the low positive serostatus group (38/50 vs. 18/50, p < 0.0001). Furthermore, samples from the former group were also found to have statistically significant higher DNA equivalent values compared to samples from the low positive serostatus group (p < 0.0001). These results suggest that meat from seropositive raccoons may contain considerable numbers of T. gondii presenting a potential public health risk for humans whilst handling and consumption.

PMID:36401669 | DOI:10.1007/s00436-022-07730-1

Eur Spine J. 2022 Nov 19. doi: 10.1007/s00586-022-07466-7. Online ahead of print.

ABSTRACT

PURPOSE: To describe the incidence of complications associated with cervical spine surgery and post-operative physical therapy (PT), and to identify if the timing of initiation of post-operative PT impacts the incidence rates.

METHODS: MOrtho PearlDiver database was queried using billing codes to identify patients who had undergone Anterior Cervical Discectomy and Fusion (ACDF), Posterior Cervical Fusion (PCF), or Cervical Foraminotomy and post-operative PT from 2010-2019. For each surgical procedure, patients were divided into three 12-week increments for post-operative PT (starting at post-operative weeks 2, 8, 12) and then matched based upon age, gender, and Charlson Comorbidity Index score. Each group was queried to determine complication rates and chi-square analysis with adjusted odds ratios, 95% confidence intervals, and p-values were used.

RESULTS: Following matching, 3,609 patients who underwent cervical spine surgery at one or more levels and had post-operative PT (ACDF:1784, PCF:1593, and cervical foraminotomy:232). The most frequent complications were new onset cervicalgia (2-14 weeks, 8-20 weeks, 12-24 weeks): ACDF (15.0%, 14.0%, 13.0%), PCF (18.8%, 18.0%, 19.9%), cervical foraminotomy (16.8%, 16.4%, 19.4%); revision: ADCF (7.9%, 8.2%, 7.4%), PCF (9.3%, 10.6%, 10.2%), cervical foraminotomy (11.6%, 10.8% and 13.4%); wound infection: ACDF (3.3%, 3.4%, 3.1%), PCF (8.3%, 8.0%,7.7%), cervical foraminotomy (5.2%, 6.5%, < 4.7%). None of the comparisons were statistically significant.

CONCLUSION: The most common post-operative complications included new onset cervicalgia, revision and wound infection. Complications rates were not impacted by the timing of initiation of PT whether at 2, 8, or 12 weeks post-operatively.

PMID:36401668 | DOI:10.1007/s00586-022-07466-7

J Hum Lact. 2022 Nov 18:8903344221135793. doi: 10.1177/08903344221135793. Online ahead of print.

ABSTRACT

BACKGROUND: Painful and damaged nipples are frequently associated with breastfeeding cessation in the early postpartum period. The results of researchers’ studies utilizing different treatments have been inconclusive.

RESEARCH AIM: To compare the intensity of nipple pain and the healing of damaged nipples during the first 10 days postpartum using either lanolin or human milk treatments.

METHODS: This single-blind randomized controlled trial included participants (N = 206) who were primiparous with painful and damaged nipples. Participants were recruited from the tertiary teaching hospital within the first 72 hr after delivery and randomized to the intervention group with lanolin (n = 103) and a human milk control group (n = 103). Data were collected in the maternity ward, 3 and 7 days after randomization. The primary outcome was nipple pain intensity and quality measured 3 and 7 days after randomization by the McGill Pain Questionnaire – short form. The nipple damage self-assessment questionnaire was used for the assessment of nipple healing. Breastfeeding self-efficacy, breastfeeding duration, and exclusivity were assessed as secondary outcomes.

RESULTS: Participants in both groups reported a statistically nonsignificant reduction in pain (quality and intensity of pain) as well as improved nipple healing 7 days after randomization. Participants in the lanolin group exclusively breastfed their infants 3 days after randomization-significantly more often than participants in the control group (p = .026). The study did not reveal any statistically significant differences for other secondary outcomes.

CONCLUSION: Both lanolin and human milk are equally effective in treating painful and damaged nipples.Registered with Clinicaltrials.gov (NCT04153513).

PMID:36401521 | DOI:10.1177/08903344221135793