Tag: pubmed

BMC Cancer. 2022 Jul 28;22(1):824. doi: 10.1186/s12885-022-09744-5.

ABSTRACT

BACKGROUND: ICIs have remarkably affected the treatment strategies for numerous malignancies, including lung cancer. However, only a fraction of patients experience durable responses to ICIs; thus, there is an urgent need to identify the parameters related to ICI therapeutic effects. In this study, we investigated nutritional status surrogates and several serum markers to estimate the efficacy of ICIs.

MATERIALS AND METHODS: The records of 66 patients with stage III/IV lung cancer who received ICIs were retrospectively analyzed. Features of patients’ clinical pathology, including age, sex, histology, line of treatment, BMI, serum albumin, serum creatinine, and serum inflammatory markers such as LMR and PLR, were examined. Progression-free survival was the primary endpoint. Relationships among categorical variables were assessed by the chi-squared test. Survival analysis was performed using the Kaplan-Meier method followed by the log-rank test. Cox multivariate analysis was performed to analyze the association between each variable and the survival time of patients.

RESULTS: The patients with BMI ≥ 25 (kg/m2), serum ALB≥37 (g/dL), serum creatinine ≥61.8 (μmol/L), LMR ≥ 2.12 had a significantly prolonged PFS in comparison with BMI<25 (kg/m2), ALB<37 (g/dL), creatinine<61.8 (μmol/L), LMR<2.12 (p < 0.05). No statistically significant difference was detected between patients with PLR < 135 and PLR ≥ 135 (p = 0.612). Multivariate analysis revealed that ALB≥37 (g/dL) and creatinine ≥ 61.8 (μmol/L) were associated with prolonged PFS, while statistical significance was not achieved in the BMI groups.

CONCLUSIONS: The current results indicated that high BMI is related to longer PFS in lung cancer patients treated with ICIs, which may be correlated with high levels of serum albumin and creatinine.

PMID:35902908 | DOI:10.1186/s12885-022-09744-5

BMC Pharmacol Toxicol. 2022 Jul 28;23(1):57. doi: 10.1186/s40360-022-00599-x.

ABSTRACT

BACKGROUND: This study compared efficacy and safety of TA4415V, a trastuzumab biosimilar, with reference trastuzumab in patients with human epidermal growth factor receptor 2-positive (HER2-positive) early-stage breast cancer treated in the neoadjuvant setting in Iran.

METHODS: Patients were randomly assigned to receive neoadjuvant TA4415V or reference trastuzumab concurrently with docetaxel (TH phase) for 4 cycles after treatment with 4 cycles of doxorubicin and cyclophosphamide (AC phase). Chemotherapy was followed by surgery. The primary endpoint was the comparison of pathologic complete response (pCR) rate in the per-protocol population. Secondary endpoints included comparisons of overall response rate (ORR), breast-conserving surgery (BCS), safety, and immunogenicity.

RESULTS: Ninety-two participants were analyzed in the per-protocol population (TA4415V, n = 48; reference trastuzumab, n = 44). The pCR rates were 37.50% and 34.09% with TA4415V and reference drug, respectively. The 95% CI of the estimated treatment outcome difference (- 0·03 [95% CI – 0.23 to 0.16]) was within the non-inferiority margin. No statistically significant difference was observed between the groups for other efficacy variables in the ITT population: ORR (89.13% vs. 83.33%; p = 0.72) and BCS (20.37% vs. 12.96%; p = 0.42) in the TA4415V and reference drug group, respectively. At least one grade 3 or 4 adverse events occurred in 27 (50%) patients in the TA4415V group versus 29 (53.70%) in the reference trastuzumab group (p = 0.70). The decrease in left ventricular ejection fraction (LVEF), as an adverse event of special interest (AESI) for trastuzumab, was compared between treatment groups in TH phase. Results demonstrated an LVEF decrease in 7 (12.96%) and 9 (16.67%) patients in TA4415V and reference trastuzumab groups, respectively (p = 0.59). Anti-drug antibodies (ADA) were not detected in any samples of groups.

CONCLUSIONS: Non-inferiority for efficacy was demonstrated between TA4415V and Herceptin based on the ratio of pCR rates in HER2-positive early breast cancer patients. In addition, ORR and BCS, as secondary endpoints, were not significantly different. Safety profile and immunogenicity were also comparable between the two groups.

PMID:35902898 | DOI:10.1186/s40360-022-00599-x

BMC Nurs. 2022 Jul 28;21(1):204. doi: 10.1186/s12912-022-00987-y.

ABSTRACT

BACKGROUND: Understanding the perspectives of healthcare workers toward patient safety-related activities is critical in maintaining a healthy safety climate. The objectives of this research are 1) to examine the perception of Patient Safety Culture (PSC) at a university hospital in Palestine, and to highlight areas in need of improvement, and 2) to assess the relationship between the outcome dimensions (frequency of events reported, and overall perceptions of safety) and the other dimensions of PSC, and 3) to determine the relationship among selected demographic variables (gender, age, hospital tenure, work tenure, profession tenure, and hours worked per week) and nurses’ perceptions of PSC.

METHODS: A cross-sectional study design was used with a convenience sample of 107 nurses. Nurses were asked by email to complete the Arabic version of the Hospital Survey of Patients’ Safety Culture (HSOPSC) using the SurveyMonkey® online account form within two weeks. The survey data were analyzed using descriptive and inferential statistics. Univariate and multiple regression were used to examine the relationships.

RESULTS: The dimensions of patient safety with the highest positive response were organizational learning and continuous improvement (87%) and teamwork within units (86%). The dimension with the lowest positive score was the nonpunitive response to error (22%). Multiple regression revealed that the dimension of communication openness was a predictor of the overall perceptions of safety (β = 0.257, p = 0.019). In addition, the dimension of feedback and communication about error was a predictor of the frequency of the reported events (β = 0.334, p = 0.005). Furthermore, age was found to be a predictor of PSC (p < 0.05).

CONCLUSIONS: This study provides a general assessment of perceived safety among nurses in a hospital. However, we found that nurses negatively perceive a nonpunitive response to error. Therefore, strenuous efforts are required by hospital management to improve the culture of incident reporting.

PMID:35902859 | DOI:10.1186/s12912-022-00987-y

BMC Psychiatry. 2022 Jul 28;22(1):507. doi: 10.1186/s12888-022-04157-x.

ABSTRACT

BACKGROUND: Substance use is referring to the use of psychoactive substances like chat, cigarettes, alcohol, and others. The use of substances particularly (alcohol, chat, and cigarette) is a major mental health burden in developing countries including Ethiopia among youth. Suicide ideation and an attempt are thinking or trying to kill oneself that facilitates the act of a person intentionally causing his or her death. Suicide is one of the most serious mental health problems and has a great social impact in the world as it is currently the third leading cause of death for youth. Youth is defined as the period of life between childhood and maturity with an age interval of (15-25).

METHOD: A cross-sectional study design was used to assess the prevalence of suicidal ideation and attempts with substance use among youth in northwest Ethiopia. Multi-stage sampling techniques of stratified with simple random sample ware used. In the first stage, substance users are selected then as the second stage among substance users the burden of suicide behavior is assessed. ASIST, DASS-21, and other tools were used to assess suicidal behavior with substance use and associated factors. Data were edited, purified, and entered into Epi-data version 4.6 before being exported to the statistical package for social sciences version 20 for analysis of bi-variables to see the associations’ p-value < 0.2 and multi-variables to identify the associated variables with a p-value of < 0.05 AOR and CI also done.

RESULTS: From a total of 372 substance user participants over all prevalence of suicidal ideation and attempt among youth was 54(14.5%) with 95% CI of (11.0,18.0) and 37(9.9%) with 95% CI (7.0, 13.0) respectively. Being female [AOR =2.36;95% CI:(1.19, 4.68)], poor social support [AOR =3.03; 95% CI: (1.11, 8.25)], and anxiety [AOR = 3.82: 95% CI; (1.96, 7.46)].

CONCLUSION AND RECOMMENDATIONS: The prevalence of suicidal ideation and attempt among substance users was 14.5 and 9.9% respectively therefore, immediate interventional actions needed to be administered to decrease the burden of suicide by reducing substance use and other associated factors.

PMID:35902853 | DOI:10.1186/s12888-022-04157-x

BMC Musculoskelet Disord. 2022 Jul 28;23(1):722. doi: 10.1186/s12891-022-05622-0.

ABSTRACT

PURPOSES: The purpose of this study was to investigate the predictive effect exerted by composite indices of femoral neck strength (compressive strength index (CSI), bending strength index (BSI) and impact strength index (ISI) on the femoral head collapse in steroid-associated ONFH patients.

METHODS: Nonoperative steroid-associated osteonecrosis of the femoral head (ONFH) patients from 2017 to 2019 were selected. The patients fell into the collapsed group and the non-collapsed group according to whether the femoral head collapsed. CSI, BSI and ISI were calculated. Moreover, bone turnover markers were measured. The statistical analysis was conducted on the predictive effects of composite indices of femoral neck strength and bone turnover index on ONFH collapse.

RESULTS: A total of 62 patients were included. The mean CSI, BSI and ISI were significantly lower in the collapsed group than those in the non-collapsed group (P < 0.05). CSI, ISI,t-P1NP and β-CTx were suggested as the protective risk factors for the femoral head collapse in ONFH patients. The ISI area under the curve values was 0. 878.The mean survival time of the hips of patients with ISI greater than 0.435 was greater (P < 0.05) than that of patients with ISI less than 0.435.

CONCLUSION: The composite indices of femoral neck strength can predict steroid-associated ONFH femoral head collapse more effectively than the bone turnover markers. The ISI value of 0.435 is a potential cut-off value, lower than this value can predict the early collapse of steroid-associated ONFH.

PMID:35902852 | DOI:10.1186/s12891-022-05622-0

BMC Psychiatry. 2022 Jul 28;22(1):511. doi: 10.1186/s12888-022-04035-6.

ABSTRACT

BACKGROUND: Due to budget restrictions in mental health care, non-professional caregivers are increasingly burdened with the emotional and practical care for their depressed relatives. However, informal family caregiving is mostly a stressful role with negative consequences on the physical and mental health of the caretakers to the extent that they have an elevated risk of experiencing psychiatric disorders themselves. While psychoeducation for relatives of depressed individuals showed positive results both in terms of the caretakers’ strain and the depressive symptoms of the affected person, there are major barriers to participate in presence in those programs. Digital programs might be a viable alternative. We found no empirically evaluated digital program available for informal caregivers of depressed patients.

METHODS: An online program for relatives of depressed individuals has been developed including four interactive modules on 1) psychoeducation, 2) how to strengthen the relationship with the depressed person, 3) how to deal with the depressive symptoms of the patient, and 4) find the right balance between caring for the depressed person and self-care. We investigate if this self-help program is more effective when used with individualized versus automated e-mail support, and if both supported conditions are more effective than treatment-as-usual (TAU in form of written information material) in terms of the risk of mental diseases in caregivers. The primary outcome is the reduction of the caregiver’s nonspecific mental distress as measured by the change of the Kessler Psychological Distress Scale score from baseline to four weeks after randomization. Caregivers (n = 500:500:250) will be randomized to one of the three conditions.

DISCUSSION: Psychological support for caregivers of individuals with mental disorders such as depression should be offered as part of integrated services. There is a huge potential to develop and implement interactive online approaches to support informal caregivers of patients with depression to function in their multiple roles and to help them to remain healthy.

TRIAL REGISTRATION: DRKS, DRKS00025241 . Registered 5 Mai 2021.

PMID:35902851 | DOI:10.1186/s12888-022-04035-6

BMC Infect Dis. 2022 Jul 28;22(1):657. doi: 10.1186/s12879-022-07647-1.

ABSTRACT

INTRODUCTION: Immunosuppressive chemotherapy increase the risk of vaccine-preventable infectious diseases in children; nevertheless, chemotherapy may result in delay or miss updated immunization schedules. The predictable antibody waning after incomplete primary immunization series may be intensified at the end of chemotherapy. This study aimed to investigate post-chemotherapy vaccine immunity waning at the end of immunosuppressive therapy in children with malignancy and hematologic disorders.

MATERIALS AND METHODS: Children with malignancies and hematologic disorders including chronic immune thrombocytopenic purpura (ITP) younger than 18 years old were enrolled from September 2015 to August 2019. Eligible patients who completed their treatment protocol for at least 6 months were recruited. The patient information, including sex, age at the date of diagnosis, number of chemotherapy sessions, underlying disease, and vaccination history, was taken by chart review using predefined questionnaires. The patient’s blood samples were obtained, and serum IgG antibody titer checked against diphtheria, tetanus, hepatitis B virus (HBV), mumps, measles, and rubella (MMR) were measured by enzyme-linked immunosorbent assay (ELISA).

RESULTS: 110 children receiving immunosuppressive chemotherapy were recruited. Forty-four (40%) of the children tested were girls and 66 (60%) were boys. The mean age of patients was 5.5 years with a range of 2 to 13 years. Of 110 studied children, 27.3% were seronegative for all antibodies. On average, patients undergo 19 episodes of chemotherapy. The mean chemotherapy sessions were significantly greater in children who were seronegative for all tested antibodies (mean: 36.2, 95% CI 33.16 to 39.24, p-value < 0.001). No statistically significant differences were observed regarding the patient’s sex and age between the seropositive and seronegative groups (p-value 0.513 and 0.060, respectively). Based on Poisson regression model analysis, the female gender was associated with 37% lower odds of seronegativity (incidence rate ratio (IIR): 0.63; [95% conf. interval: 0.39 to 1.01, p-value: 0.55]), while chemotherapy sessions 30 or more was associated with significant odds of seronegativity for all tested vaccines (IIR: 25.41; [95% conf. interval: 6.42 to 100.57, p-value < 0.001]).

CONCLUSION: Our results reemphasized planned catchup immunization in children undergoing immunosuppressive chemotherapy for malignancy, especially against tetanus, diphtheria, and hepatitis B at least 6 months after the end of chemotherapy sessions.

PMID:35902837 | DOI:10.1186/s12879-022-07647-1

BMC Psychiatry. 2022 Jul 29;22(1):513. doi: 10.1186/s12888-022-04160-2.

ABSTRACT

BACKGROUND: In Latin America and the Caribbean, there is a dearth of research exploring polysubstance use. This study aims to determine the prevalence, varying combinations and associated sociodemographic characteristics of polysubstance use in Jamaica.

METHODS: This study involved a secondary data analysis of the Jamaica National Drug Prevalence Survey 2016 dataset where 4,623 participants between the age of 12 and 65 years from each household were randomly selected as respondents. Statistical analysis was performed to determine the prevalence and the sociodemographic correlates of polysubstance use among Jamaicans.

RESULTS: 19.6% of respondents used two or more drugs in their lifetime. Of this amount 68.7% reported past year use and 61.9% reported past month use. Bivariate analyses reported polysubstance use was statistically significantly higher amongst males (U = 54,579, p = 0.000), those living in rural areas (U = 91,892, p = 0.003), non-Christian (U = 89,514, p = 0.014), and married persons (U = 74,672, p = 0.000). Past month polysubstance use was statistically significantly higher among employed persons than unemployed persons were (U = 81,342, p = 0.001). Surprisingly, there was a lack of significant differences between education level, household income and past month concurrent polysubstance use (p = 0.609; p = 0.115 respectively). Logistic regression model indicated males were 3.076 times more likely than females to report past month polysubstance use than females. Also, when compared to those 55-65 years old, participants 35-54 years were 2.922 times more likely and those 18-34 years were 4.914 times more likely to report past month polysubstance use. Additionally, those living in rural areas were 1.508 times more likely than participants living in urban areas to report past month polysubstance use. As it relates to occupational status, when compared to armed forces, skilled workers were 4.328 times more likely and unskilled workers were 7.146 times more likely to report past month polysubstance use.

CONCLUSIONS: One in five Jamaicans identified as polysubstance users, predominated by marijuana as the most common factor amongst the polysubstance combinations examined, signalling the need for early marijuana interventions.

PMID:35902836 | DOI:10.1186/s12888-022-04160-2

BMC Public Health. 2022 Jul 28;22(1):1437. doi: 10.1186/s12889-022-13870-x.

ABSTRACT

BACKGROUND: COVID-19 related lockdowns may have affected engagement in health behaviours among the UK adult population. This prospective observational study assessed socio-demographic patterning in attempts to change and maintain a range of health behaviours and changes between two time points during the pandemic.

METHODS: Adults aged 18 years and over (n = 4,978) were recruited using Dynata (an online market research platform) and the HealthWise Wales platform, supplemented through social media advertising. Online surveys were conducted in August/September 2020 when lockdown restrictions eased in the UK following the first major UK lockdown (survey phase 1) and in February/March 2021 during a further national lockdown (survey phase 2). Measures derived from the Cancer Awareness Measure included self-reported attempts to reduce alcohol consumption, increase fruit/vegetable consumption, increase physical activity, lose weight and reduce/stop smoking. Multivariable logistic regressions were used to assess individual health behaviour change attempts over time, adjusted for age, sex, ethnicity, employment and education.

RESULTS: Around half of participants in survey phase 1 reported trying to increase physical activity (n = 2607, 52.4%), increase fruit/vegetables (n = 2445, 49.1%) and lose weight (n = 2413, 48.5%), with 19.0% (n = 948) trying to reduce alcohol consumption among people who drink. Among the 738 participants who smoked, 51.5% (n = 380) were trying to reduce and 27.4% (n = 202) to stop smoking completely. Most behaviour change attempts were more common among women, younger adults and minority ethnic group participants. Efforts to reduce smoking (aOR: 0.98, 95% CI: 0.82-1.17) and stop smoking (aOR: 0.98, 95% CI: 0.80-1.20) did not differ significantly in phase 2 compared to phase 1. Similarly, changes over time in attempts to improve other health behaviours were not statistically significant: physical activity (aOR: 1.07; 95% CI: 0.99-1.16); weight loss (aOR: 0.95; 95% CI: 0.90-1.00); fruit/vegetable intake (aOR: 0.98, 95% CI: 0.91-1.06) and alcohol use (aOR: 1.32, 95% CI: 0.92-1.91).

CONCLUSION: A substantial proportion of participants reported attempts to change health behaviours in the initial survey phase. However, the lack of change observed over time indicated that overall motivation to engage in healthy behaviours was sustained among the UK adult population, from a period shortly after the first lockdown toward the end of the second prolonged lockdown.

PMID:35902822 | DOI:10.1186/s12889-022-13870-x

BMC Infect Dis. 2022 Jul 28;22(1):654. doi: 10.1186/s12879-022-07621-x.

ABSTRACT

BACKGROUND: The rapid course of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic calls for fast implementation of clinical trials to assess the effects of new treatment and prophylactic interventions. Building trial platforms embedded in existing data infrastructures is an ideal way to address such questions within well-defined subpopulations.

METHODS: We developed a trial platform building on the infrastructure of two established national cohort studies: the Swiss human immunodeficiency virus (HIV) Cohort Study (SHCS) and Swiss Transplant Cohort Study (STCS). In a pilot trial, termed Corona VaccinE tRiAL pLatform (COVERALL), we assessed the vaccine efficacy of the first two licensed SARS-CoV-2 vaccines in Switzerland and the functionality of the trial platform.

RESULTS: Using Research Electronic Data Capture (REDCap), we developed a trial platform integrating the infrastructure of the SHCS and STCS. An algorithm identifying eligible patients, as well as baseline data transfer ensured a fast inclusion procedure for eligible patients. We implemented convenient re-directions between the different data entry systems to ensure intuitive data entry for the participating study personnel. The trial platform, including a randomization algorithm ensuring balance among different subgroups, was continuously adapted to changing guidelines concerning vaccination policies. We were able to randomize and vaccinate the first trial participant the same day we received ethics approval. Time to enroll and randomize our target sample size of 380 patients was 22 days.

CONCLUSION: Taking the best of each system, we were able to flag eligible patients, transfer patient information automatically, randomize and enroll the patients in an easy workflow, decreasing the administrative burden usually associated with a trial of this size.

PMID:35902817 | DOI:10.1186/s12879-022-07621-x