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Nevin Manimala Statistics

Comparison of second-line treatments in metastatic renal cell carcinoma patients: A single-center experience

Medicine (Baltimore). 2023 Oct 13;102(41):e35245. doi: 10.1097/MD.0000000000035245.

ABSTRACT

Renal cell carcinoma is the 10th most common type of cancer, accounting for 3.7% of all cancers. Our study examines patients with metastatic renal cell carcinoma who received Axitinib or Nivolumab as second-line treatment. This study was designed as a retrospective analysis. Patients who received Axitinib or Nivolumab as second-line treatment for metastatic renal cell carcinoma at the Istanbul University Oncology Institute Medical Oncology outpatient clinic were included in the study. A total of 81 patients were included in the study, with a median follow-up period of 18.5 months (2-260 months). Of these patients, 29 (35.8%) received Axitinib as second-line treatment, while 52 (64.2%) received Nivolumab. The median duration of second-line treatment was 14 months (6-52) for Axitinib and 13.5 months (3-77) for Nivolumab. In our study, Nivolumab was found to have statistically better PFS and OS outcomes than Axitinib in male patients, patients diagnosed with metastatic disease, those with a favorable or intermediate International Metastatic Renal Cell Carcinoma Database Consortium risk score, patients diagnosed with metastatic disease or who developed metastasis within 12 months of diagnosis, those who developed metastasis ≥ 24 months after diagnosis, and patients with metastasis in a single organ. Both drugs are recommended as monotherapy for second-line and later treatments in the current NCCN guidelines for kidney cancers. Although there is no study in the literature showing that axitinib is more effective than nivolumab, nivolumab was found to be much more effective than axitinib in our study. Prospective studies with higher number of patients are needed on this subject.

PMID:37832108 | DOI:10.1097/MD.0000000000035245

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Frequency of fibromyalgia in a cohort of Turkish patients with lung cancer and its effect on pain, sleep quality, fatigue and quality of life

Medicine (Baltimore). 2023 Oct 13;102(41):e35586. doi: 10.1097/MD.0000000000035586.

ABSTRACT

This study aimed to examine the frequency of fibromyalgia (FM) in patients with lung cancer and evaluate its effect on patients’ pain, sleep quality, fatigue, and quality of life parameters. The study was designed as a prospective cross-sectional and a total of 116 lung cancer patients were included. FM classification was made according to the 2016 ACR criteria. All patients were evaluated using a visual analog scale, fibromyalgia impact questionnaire, multidimensional assessment of fatigue, EuroQol 5D scale, Jenkins sleep scale, and Beck depression inventory. Patients were divided into FM-positive and negative groups according to the presence of FM. Demographic and clinical parameters were investigated between the groups. FM was detected in 14 (12.2%) patients. The mean age of the patients was 62.2 ± 8.4 years. There was a male predominance in 93 (80.2%) patients. No statistical difference was found between the groups in terms of body mass index, age, symptom duration, chemotherapy, and radiotherapy history. A statistically significant difference was found between FM positive and negative groups in FIQ, multidimensional assessment of fatigue, JSS, EQ-5D, visual analog scale, and Beck depression inventory scores. FM is seen more frequently in patients with lung cancer and has a negative effect on sleep, quality of life, fatigue, and mental functions. We think that physicians should not ignore the presence of FM when treating patients diagnosed with lung cancer.

PMID:37832106 | DOI:10.1097/MD.0000000000035586

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Meta-analysis of the effectiveness and safety of Xingnaojing and naloxone in the treatment of carbon monoxide poisoning

Medicine (Baltimore). 2023 Oct 13;102(41):e33199. doi: 10.1097/MD.0000000000033199.

ABSTRACT

BACKGROUND: To evaluate the effectiveness and safety of Xingnaojing combined with naloxone in the treatment of carbon monoxide poisoning.

METHODS: By retrieving the literatures published in the databases of PubMed, Cochrane Library, Web of Science, Embase, Wanfang Database, Weipu Database, and China National Knowledge Infrastructure from January 2010 to September 2021, the data of randomized controlled trials (RCTs) of Xingnaojing combined with naloxone in the treatment of carbon monoxide poisoning were extracted. The methodological quality of the included RCTs was evaluated by using the tools of bias risk evaluation of Cochrane Collaboration, and the data were statistically analyzed by using RevMan 5.3 software.

RESULTS: A total of 20 literatures were included, involving in 771 cases treated by Xingnaojing combined with naloxone and 761 cases in the control group. The effective rate of the experimental group is higher than that of the control group [risk ratio (RR) = 1.20, 95% confidence interval (CI) (1.14, 1.26)]. The average awake time (STD mean difference = -2.08, 95% CI [-2.60, -1.56]), physical recovery time (STD mean difference = -2.94, 95% CI [-3.59, -2.28]), delayed encephalopathy (RR = 0.44, 95% CI [0.31, 0.62]), and adverse reactions (RR = 0.23, 95% CI [0.10, 0.54]) was lower than that of the control group.

CONCLUSION: Xingnaojing combined with naloxone in the treatment of carbon monoxide poisoning is significantly superior to naloxone, but it still needs to be further verified by high-quality large samples of RCTs.

PMID:37832102 | DOI:10.1097/MD.0000000000033199

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Clinical efficacy of dexamethasone on diabetic ketoacidosis complicated with acute pancreatitis: A randomized controlled study

Medicine (Baltimore). 2023 Oct 13;102(41):e35320. doi: 10.1097/MD.0000000000035320.

ABSTRACT

BACKGROUND: This study aimed to provide a clinical basis for the therapy of diabetic ketoacidosis (DKA) complicated with acute pancreatitis (AP) through exploring the clinical efficacy of dexamethasone.

METHODS: A total of 106 DKA patients complicated with AP admitted to Wuxi People’s Hospital Affiliated to Nanjing Medical University from January 2020 to December 2022 were selected and randomly divided into a study group (n = 53) and a placebo group (n = 53) according to the random number table method. The study group patients were given dexamethasone, while the placebo group patients were treated using placebos. Subsequently, changes of laboratory indexes and clinical symptoms before and after treatment were compared between the 2 groups, as well as adverse events after treatment.

RESULTS: There was no significant difference between the 2 groups in terms of general information (P > .05), indicating that the 2 groups patients were comparable. Before treatment, laboratory indexes and clinical symptoms between the 2 groups were not significantly different (P > .05). After treatment, compared with the placebo group, patients in the study group exhibited lower levels of indicators such as random venous blood glucose, serum sodium, serum chlorine, urea nitrogen, urine glucose, urine ketone, serum amylase, and triglyceride and higher levels of PH value and serum potassium, with a statistically significant difference (P < .05); also, the study group patients were improved significantly in clinical symptoms such as abdominal pain, nausea and vomiting, polydipsia and polyuria, diarrhea, disorders of consciousness and hypotension or shock (P < .05). Moreover, the possibility of adverse events in the study group after treatment was much lower than that in the control group (17.0% vs 58.5%) (P < .05).

CONCLUSION: Dexamethasone has a good clinical effect on DKA patients complicated with AP.

PMID:37832092 | DOI:10.1097/MD.0000000000035320

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Prediction of reported monthly incidence of hepatitis B in Hainan Province of China based on SARIMA-BPNN model

Medicine (Baltimore). 2023 Oct 13;102(41):e35054. doi: 10.1097/MD.0000000000035054.

ABSTRACT

In recent years, the incidence of hepatitis B has been serious in Hainan Province of China. To construct a statistical model of the monthly incidence of hepatitis B in Hainan Province of China and predict the monthly incidence of hepatitis B in 2022. Simple central moving average method and seasonal index were used to analyze the trend and seasonal effects of monthly incidence of hepatitis B. Based on the time series of reported monthly incidence of hepatitis B in Hainan Province from 2017 to 2020, a multiplicative seasonal model (SARIMA), multiplicative seasonal model combined with error back propagation neural network model (SARIMA-BPNN), and a gray prediction model were constructed to fit the incidence, and the time series of monthly incidence of hepatitis B in 2021 was used to verify the accuracy of models. The lowest and highest monthly incidence of hepatitis B in Hainan Province were in February and August, respectively, and MAPE of SARIMA, SARIMA-BPNN, and gray prediction models were 0.089, 0.087, and 0.316, respectively. The best fitting model is the SARIMA-BPNN model. The predicted monthly incidence of hepatitis B in 2022 showed a downward trend, with the steepest decline in March, which indicates that the prevention and control of hepatitis B in Hainan Province is effective, and the study can provide scientific and reasonable suggestions for the prevention and control of hepatitis B in Hainan.

PMID:37832091 | DOI:10.1097/MD.0000000000035054

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Perceptions of Competition-Based Learning After a Brief Experience at a National Surgical Meeting

Surg Innov. 2023 Oct 13:15533506231207438. doi: 10.1177/15533506231207438. Online ahead of print.

ABSTRACT

BACKGROUND: Competition-based learning (CBL) facilitates learning through competitions. At the 2022 & 2023 Annual SAGES meetings, we evaluated a CBL experience (TOP GUN Shootout) developed from a modified version of the previously validated TOP GUN Laparoscopic Skills and Suturing Program. The project sought to evaluate the TOP GUN Shootout’s (TGS) ability to enhance participant engagement in pursuit of laparoscopic surgical skills.

METHODS: Participants competed in the TGS. Their scores (time and errors) were recorded for: Fundamentals of Laparoscopic Surgery Peg Pass, Cup Drop Task, and Intracorporeal Suturing. All participants completed a 10-question satisfaction survey on a 7-point Likert scale, with questions assessing 3 domains: (1) capability/confidence in MIS skill performance prior to the competition; (2) applicability and satisfaction with TGS’s capacity to develop MIS skills; and (3) interest in seeking additional MIS training and appropriateness of CBL in MIS training. Descriptive statistics were used to evaluate these areas.

RESULTS: Overall, 121 participants completed the TGS, of whom 84 (69%) completed the satisfaction survey. The average age was 32.9 years, 67% were males. On average (+/- SD), participant satisfaction was 5.04 (+/- 2.08) for Domain 1, 6.20 (+/- 1.28) for Domain 2, and 6.58 (+/- .95) for Domain 3.

CONCLUSION: Participants described an overall lack of confidence in their MIS skills prior to the 2022-2023 Annual SAGES conference. Participants felt that this brief CBL experience, aided in the development of their MIS skills. Furthermore, this brief CBL experience may inspire learners to seek out further training of their MIS skills.

PMID:37831491 | DOI:10.1177/15533506231207438

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Commercially Available Mobile Apps With Family Behavioral Goal Setting and Tracking for Parents: Review and Quality Evaluation

JMIR Pediatr Parent. 2023 Oct 13;6:e41779. doi: 10.2196/41779.

ABSTRACT

BACKGROUND: Goal setting and tracking are well established behavior change techniques. Little is known about the extent to which commercially available mobile apps are designed to guide parents in using these strategies, their evidence base, and their quality.

OBJECTIVE: This study aims to review commercially available apps that target parents in relation to setting and tracking behavioral goals for their children. The objectives were to classify the apps’ general characteristics, features, evidence base, and target behaviors and assess app quality overall and separately for apps that target health-related behaviors (HRBs) and apps without a health-related behavior (WHRB).

METHODS: Apps were identified using keyword searches in the Apple App Store and Google Play in the United States. Apps were included if their primary purpose was to assist with setting goals, tracking goals, tracking behaviors, or giving feedback pertaining to goals for children by parents. App characteristics and common features were documented and summarized. Two reviewers assessed app quality using the Mobile App Rating Scale (MARS). Descriptive statistics summarized the MARS total score, 4 quality subscales, and 6 app-specific items that reflect the perceived impact of the app on goal setting and tracking, overall and with subgroup analysis for HRB and WHRB apps.

RESULTS: Of the 21 apps identified, 16 (76%) met the review criteria. Overall, 9 apps defined and targeted the following HRBs: nutrition and mealtime (6/16, 38%), physical activity and screen time (5/16, 31%), sleep (7/16, 44%), and personal hygiene (6/16, 38%). Three apps targeted specific age groups (2 apps were for children aged 6-13 years and 1 app was for children aged ≥4 years). None of the apps provided tailored assessments or guidance for goal setting. None of the apps indicated that they were intended for the involvement of a health professional or had been tested for efficacy. The MARS total score indicated moderate app quality overall (mean 3.42, SD 0.49) and ranged from 2.5 to 4.2 out of 5 points. The Habitz app ranked highest on the MARS total score among HRB apps (score=4.2), whereas Thumsters ranked highest (score=3.9) among the WHRB apps. Subgroup analysis revealed a pattern of higher quality ratings in the HRB group than the WHRB group, including the mean MARS total score (mean 3.67, SD 0.34 vs mean 3.09, SD 0.46; P=.02); the engagement and information subscales; and the app-specific items about perceived impact on knowledge, attitudes, and behavior change.

CONCLUSIONS: Several high-quality commercially available apps target parents to facilitate goal setting and tracking for child behavior change related to both health and nonhealth behaviors. However, the apps lack evidence of efficacy. Future research should address this gap, particularly targeting parents of young children, and consider individually tailored guided goal setting and involvement of health professionals.

PMID:37831486 | DOI:10.2196/41779

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Acceptability and Feasibility of Online Support Groups for Mental Health Promotion in Brazilian Graduate Students During the COVID-19 Pandemic: Longitudinal Observational Study

JMIR Form Res. 2023 Oct 13;7:e44887. doi: 10.2196/44887.

ABSTRACT

BACKGROUND: The outbreak of the COVID-19 pandemic in 2020 aggravated already existing difficulties and added new challenges for students. Owing to the gap between needed and available psychological services, group interventions may offer a helpful strategy for student mental health promotion.

OBJECTIVE: This study aimed to investigate the acceptability and feasibility of a 4-week online support group program designed for mental health promotion tailored to graduate students at a Brazilian public university in the context of the COVID-19 pandemic (May 2022 to June 2022).

METHODS: Participants in the program took part in online support groups based on a pilot group facilitated by a trained clinical psychologist. Self-administered, standardized web-based questionnaires were assessed at the baseline (T0; before the intervention), postintervention (T2), and follow-up (T3; after 4-6 weeks) time points. We measured sociodemographic variables, treatment credibility and expectancy (Credibility and Expectancy Questionnaire), satisfaction (Client Satisfaction Questionnaire), negative effects of the intervention (Negative Effects Questionnaire), depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]), and participants’ quality of life (abbreviated World Health Organization Quality of Life assessment). A 9-answer option questionnaire and open-ended questions also assessed the group’s perceived positive and negative outcomes.

RESULTS: The total sample comprised 32 participants. Most (23/32, 72%) were doctoral students. Credibility and expectancy scores were high. Participants’ satisfaction (Client Satisfaction Questionnaire) with the program was high at the postintervention (T2) and follow-up (T3) evaluations (T2: mean 28.66, SD 3.02; T3: mean 27.91, SD 3.02). Most participants reported that they could learn from other participants’ experiences (T2: 29/32, 91%; T3: 27/32, 84%) and felt encouraged to take better care of themselves (T2: 22/32, 69%; T3: 24/32, 75%). None of the participants reported that they had no benefits from the program. The PHQ-9 scores showed mild to moderate depressive symptoms (mean 9.59, SD 6.34), whereas the answers of 9% (3/32) of the participants to the PHQ-9 item 9 indicated suicidality at baseline (T0). Finally, the 4 domains of quality of life (physical: P=.01; psychological: P=.004; social: P=.02; and environmental: P<.001) showed a slight and statistically significant improvement at the postintervention evaluation (T0: mean 57.03, SD 15.39 to 59.64, SD 17.21; T2: mean 64.32, SD 11.97 to 68.75, SD 8.87).

CONCLUSIONS: Online support groups for the mental health promotion of graduate students are feasible and can be especially useful for universities with students allocated to different cities. They are also satisfactory and may positively influence participants’ quality of life. Therefore, they can be considered a helpful mental health promotion strategy in the educational context. Further studies could evaluate these (or similar) programs under nonpandemic circumstances.

PMID:37831483 | DOI:10.2196/44887

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Obesity and Risk of Recurrence in Patients With Breast Cancer Treated With Aromatase Inhibitors

JAMA Netw Open. 2023 Oct 2;6(10):e2337780. doi: 10.1001/jamanetworkopen.2023.37780.

ABSTRACT

IMPORTANCE: Clinical studies confirm that obesity is a risk factor for recurrence in postmenopausal women with hormone receptor-positive (HR+) breast cancer. Evidence suggests that women with obesity do not obtain similar protection from aromatase inhibitors as women with healthy weight.

OBJECTIVE: To examine the associations of body mass index (BMI) with recurrence.

DESIGN, SETTING, AND PARTICIPANTS: The cohort study was conducted using data from the Danish Breast Cancer Group and enrolled postmenopausal women diagnosed with stage I to III HR+ breast cancer from 1998 through 2016. Data analysis was conducted from November 2022 to April 2023.

EXPOSURES: BMI was classified as (1) healthy weight (18.5-24.9), (2) overweight (25.0-29.9), (3) obesity (30.0-34.9), and (4) severe obesity (≥35.0) using the World Health Organization guidelines. Healthy weight was considered the reference group in statistical analyses.

MAIN OUTCOMES AND MEASURES: Follow-up began 6 months after breast cancer surgery and continued until the first event of recurrence, contralateral breast cancer, new primary malignant neoplasm, death, emigration, end of clinical follow-up at 10 years, or September 25, 2018. Cox regression was used to estimate crude and adjusted hazard ratios with 95% CIs, adjusting for patient, tumor, and treatment characteristics.

RESULTS: A total of 13 230 patients (median [IQR] age at diagnosis, 64.4 [58.6-70.2] years) with information on BMI were enrolled. There were 1587 recurrences with a median (IQR) potential estimated follow-up of 6.2 (3.6-8.5) years. Multivariable analyses revealed increased recurrence hazards associated with obesity (adjusted hazard ratio, 1.18 [95% CI, 1.01-1.37]) and severe obesity (adjusted hazard ratio, 1.32 [95% CI, 1.08-1.62]) vs patients with healthy weight. Patients with overweight had a greater risk, but the results were not statistically significant (adjusted hazard ratio, 1.10 [95% CI, 0.97-1.24]).

CONCLUSIONS AND RELEVANCE: In this study, obesity was associated with an increased risk of breast cancer recurrence among postmenopausal patients with HR+ early-stage breast cancer treated with aromatase inhibitors. Physicians should be aware of the significance of obesity on breast cancer outcomes to secure optimal treatment benefit in all patients.

PMID:37831449 | DOI:10.1001/jamanetworkopen.2023.37780

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Model-Guided Decision-Making for Thromboprophylaxis and Hospital-Acquired Thromboembolic Events Among Hospitalized Children and Adolescents: The CLOT Randomized Clinical Trial

JAMA Netw Open. 2023 Oct 2;6(10):e2337789. doi: 10.1001/jamanetworkopen.2023.37789.

ABSTRACT

IMPORTANCE: Rates of hospital-acquired venous thromboembolism (HA-VTE) are increasing among pediatric patients. Identifying at-risk patients for whom prophylactic interventions should be considered remains challenging.

OBJECTIVE: To determine whether use of a previously validated HA-VTE prognostic model, together with pediatric hematologist review, could reduce pediatric inpatient rates of HA-VTE.

DESIGN, SETTING, AND PARTICIPANTS: This pragmatic randomized clinical trial was performed from November 2, 2020, through January 31, 2022, at a single-center academic children’s hospital (Monroe Carell Jr Children’s Hospital at Vanderbilt). All pediatric hospital admissions (aged <22 years) under inpatient status were included and randomized.

INTERVENTION: All patients had an HA-VTE probability automatically calculated daily, which was visible to the hematology research team for patients in the intervention group. Patients with an elevated risk (predicted probability ≥2.5%) underwent additional medical record review by the research team to determine eligibility for thromboprophylaxis.

MAIN OUTCOMES AND MEASURES: The primary outcome was rate of HA-VTE. Secondary outcomes included rates of prophylactic anticoagulation and anticoagulation-associated bleeding events.

RESULTS: A total of 17 427 hospitalizations met eligibility criteria, were randomized, and were included in the primary analysis: patients had a median (IQR) age of 1.7 (0 to 11.1) years; there were 9143 (52.5%) female patients and 8284 (47.5%) male patients, and there were 445 (2.6%) Asian patients, 2739 (15.9%) Black patients, and 11 752 (67.4%) White patients. The 2 groups were evenly balanced in number (8717 in the intervention group and 8710 in the control group) and patient characteristics. A total of 58 patients (0.7%) in the control group and 77 (0.9%) in the intervention group developed HA-VTE (risk difference: 2.2 per 1000 patients; 95% CI, -0.4 to 4.8 per 1000 patients; P = .10). Recommendations to initiate thromboprophylaxis were accepted by primary clinical teams 25.8% of the time (74 of 287 hospitalizations). Minor bleeding events were rare among patients who received anticoagulation (3 of 74 [4.1%]), and no major bleeding events were observed during the study period. Among patients randomized to the control group, the model exhibited high discrimination accuracy (C statistic, 0.799, 95% CI, 0.725 to 0.856).

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of the use of a HA-VTE prognostic model to reduce pediatric inpatient rates of HA-VTE, despite the use of an accurate and validated prognostic model for HA-VTE, there was substantial reluctance by primary clinical teams to initiate thromboprophylaxis as recommended. In this context, rates of HA-VTE between the control and intervention groups were not different. Future research is needed to identify improved strategies for prevention of HA-VTE and to overcome clinician concerns regarding thromboprophylaxis.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04574895.

PMID:37831448 | DOI:10.1001/jamanetworkopen.2023.37789