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Nevin Manimala Statistics

Decentralized clinical trials and rare diseases: a Drug Information Association Innovative Design Scientific Working Group (DIA-IDSWG) perspective

Orphanet J Rare Dis. 2023 Apr 11;18(1):79. doi: 10.1186/s13023-023-02693-7.

ABSTRACT

BACKGROUND: Traditional clinical trials require tests and procedures that are administered in centralized clinical research sites, which are beyond the standard of care that patients receive for their rare and chronic diseases. The limited number of rare disease patients scattered around the world makes it particularly challenging to recruit participants and conduct these traditional clinical trials.

MAIN BODY: Participating in clinical research can be burdensome, especially for children, the elderly, physically and cognitively impaired individuals who require transportation and caregiver assistance, or patients who live in remote locations or cannot afford transportation. In recent years, there is an increasing need to consider Decentralized Clinical Trials (DCT) as a participant-centric approach that uses new technologies and innovative procedures for interaction with participants in the comfort of their home.

CONCLUSION: This paper discusses the planning and conduct of DCTs, which can increase the quality of trials with a specific focus on rare diseases.

PMID:37041605 | DOI:10.1186/s13023-023-02693-7

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Early ambulation and postoperative recovery of patients with lung cancer under thoracoscopic surgery-an observational study

J Cardiothorac Surg. 2023 Apr 11;18(1):136. doi: 10.1186/s13019-023-02263-9.

ABSTRACT

BACKGROUND: Enhanced recovery after surgery guidelines in China recommend early ambulation within 24 h after surgery. The aims of this audit were to investigate the early ambulation of patients with lung cancer under thoracoscopic surgery, and to explore the influence of different ambulation time on postoperative rehabilitation of patients.

METHODS: Using observational study method, observe and record of 226 cases under the thoracoscope surgery early ambulation of patients with lung cancer. Data collected included postoperative bowel movements, chest tube extubation time, length of hospital stay, postoperative pain and the incidence of postoperative complications.

RESULTS: The time of first ambulation was (34.18 ± 17.18) h, the duration was (8.26 ± 4.62) min, and the distance was (54.94 ± 46.06) m. The time of first postoperative defecation, the time of chest tube extubation and the length of hospital stay were significantly shortened in patients who ambulate within 24 h, and the pain score on the third day after surgery was decreased, and the incidence of postoperative complications was reduced, with statistical significance (P < 0.05).

CONCLUSION: Early ambulation within 24 h after thoracoscopic surgery for lung cancer patients can promote the recovery of intestinal function, early removal of chest tube, shorten the length of hospital stay, relieve pain, reduce the incidence of complications, and facilitate the rapid recovery of patients.

PMID:37041603 | DOI:10.1186/s13019-023-02263-9

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Benefits of sacubitril/valsartan use in patients with chronic heart failure after cardiac valve surgery: a single-center retrospective study

J Cardiothorac Surg. 2023 Apr 11;18(1):138. doi: 10.1186/s13019-023-02252-y.

ABSTRACT

OBJECTIVES: To evaluate the efficacy of sacubitril/valsartan for the treatment of patients with chronic heart failure (CHF) after cardiac valve surgery (CVS).

METHODS: Data were collected from 259 patients who underwent CVS due to valvular heart disease and were admitted to the hospital with CHF from January 2018 to December 2020. The patients were divided into Group A (treatment with sacubitril/valsartan) and Group B (treatment without sacubitril/valsartan). The duration of treatment and follow-up was 6 months. The two groups’ prior and clinical characteristics, post-treatment data, mortality, and follow-up data were analysed.

RESULTS: The effective rate of Group A was higher than that of Group B (82.56% versus 65.52%, P < 0.05). The left ventricular ejection fraction (LVEF, %) was improved in both groups. The final value minus the initial value was (11.14 ± 10.16 versus 7.15 ± 11.18, P = 0.004). The left ventricular end-diastolic/-systolic diameter (LVEDD/LVESD, mm) in Group A decreased more than in Group B. The final value minus the initial value was (-3.58 ± 9.21 versus – 0.27 ± 14.44, P = 0.026; -4.21 ± 8.15 versus – 1.14 ± 12.12, P = 0.016, respectively). Both groups decreased the N-terminal prohormone of B-type natriuretic peptide (NT-proBNP, pg/ml). The final value minus initial value was [-902.0(-2226.0, -269.5) versus – 535.0(-1738, -7.0), P = 0.029]. The systolic and diastolic blood pressure (SBP/DBP, mmHg) in Group A decreased more than in Group B. The final value minus the initial value was (-13.13 ± 23.98 versus – 1.81 ± 10.89, P < 0.001; -8.28 ± 17.79 versus – 2.37 ± 11.41, P = 0.005, respectively). Liver and renal insufficiency, hyperkalaemia, symptomatic hypotension, angioedema, and acute heart failure had no statistical differences between the two groups.

CONCLUSIONS: Sacubitril/valsartan can effectively improve the cardiac function of patients with CHF after CVS by increasing LVEF and reducing LVEDD, LVESD, NT-proBNP, and BP, with good safety.

PMID:37041595 | DOI:10.1186/s13019-023-02252-y

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Effects of the COVID-19 pandemic on mental health, anxiety, and depression

BMC Psychol. 2023 Apr 11;11(1):108. doi: 10.1186/s40359-023-01130-5.

ABSTRACT

BACKGROUND: The COVID-19 pandemic affected everyone around the globe. Depending on the country, there have been different restrictive epidemiologic measures and also different long-term repercussions. Morbidity and mortality of COVID-19 affected the mental state of every human being. However, social separation and isolation due to the restrictive measures considerably increased this impact. According to the World Health Organization (WHO), anxiety and depression prevalence increased by 25% globally. In this study, we aimed to examine the lasting effects of the COVID-19 pandemic on the general population.

METHODS: A cross-sectional study using an anonymous online-based 45-question online survey was conducted at Comenius University in Bratislava. The questionnaire comprised five general questions and two assessment tools the Zung Self-Rating Anxiety Scale (SAS) and the Zung Self-Rating Depression Scale (SDS). The results of the Self-Rating Scales were statistically examined in association with sex, age, and level of education.

RESULTS: A total of 205 anonymous subjects participated in this study, and no responses were excluded. In the study group, 78 (38.05%) participants were male, and 127 (61.69%) were female. A higher tendency to anxiety was exhibited by female participants (p = 0.012) and the age group under 30 years of age (p = 0.042). The level of education has been identified as a significant factor for changes in mental state, as participants with higher levels of education tended to be in a worse mental state (p = 0.006).

CONCLUSIONS: Summarizing two years of the COVID-19 pandemic, the mental state of people with higher levels of education tended to feel worse, while females and younger adults felt more anxiety.

PMID:37041568 | DOI:10.1186/s40359-023-01130-5

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Nevin Manimala Statistics

Efficacy of personalized exercise program on physical function in elderly patients with rheumatoid arthritis at high risk for sarcopenia: study protocol for a randomized controlled trial

BMC Musculoskelet Disord. 2023 Apr 11;24(1):280. doi: 10.1186/s12891-023-06185-4.

ABSTRACT

BACKGROUND: Patients with rheumatoid arthritis (RA) are prone to muscle atrophy due to inflammatory cytokines and corticosteroid use and immobility due to joint pain and deformity. Although resistance training is effective and safe in reversing muscle atrophy in RA, some patients are unable to perform a conventional high-load exercise program due to disease-related limitations. This study aims to examine the efficacy of individualized exercise therapy on physical function in elderly patients with RA who are at a high risk for sarcopenia.

METHODS: This study is a single-center, parallel-group, two-arm, healthcare provider- and outcome assessor-blinded, superiority randomized controlled trial with a 1:1 allocation ratio. A total of 160 participants with RA between 60 and 85 years of age with a positive screening test for sarcopenia will be included. The intervention group will receive nutritional guidance and a four-month individualized exercise program in addition to the usual treatment. The control group will receive nutritional guidance in addition to the usual care. The primary endpoint will be physical function assessed using the Short Physical Performance Battery (SPPB) at 4 months. The data on outcome measures will be collected at baseline and at the two- and four-month follow-ups. Linear mixed-effects models for repeated measures will be conducted using the modified intention-to-treat analysis population.

DISCUSSION: This study will provide evidence on whether a personalized exercise program can improve physical function and quality of life in elderly patients with RA. Some limitations include limited generalizability due to the single-center study and lack of blinding of the patients to the intervention assignment because of the nature of the exercise. Physical therapists may use this knowledge in their daily practice to improve RA treatment. Tailored exercise may enhance the health outcomes of the RA population and contribute to a reduction in healthcare costs.

TRIAL REGISTRATION: The study protocol was retrospectively registered at the University hospital Medical Information Network-Clinical Trial Repository (UMIN-CTR) (registration number: UMIN000044930, https://www.umin.ac.jp/ctr/index-j.htm ) on January 4, 2022.

PMID:37041556 | DOI:10.1186/s12891-023-06185-4

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Nevin Manimala Statistics

A nomogram model based on pre-treatment and post-treatment MR imaging radiomics signatures: application to predict progression-free survival for nasopharyngeal carcinoma

Radiat Oncol. 2023 Apr 11;18(1):67. doi: 10.1186/s13014-023-02257-w.

ABSTRACT

BACKGROUND: To establish a novel model using radiomics analysis of pre-treatment and post-treatment magnetic resonance (MR) images for prediction of progression-free survival in the patients with stage II-IVA nasopharyngeal carcinoma (NPC) in South China.

METHODS: One hundred and twenty NPC patients who underwent chemoradiotherapy were enrolled (80 in the training cohort and 40 in the validation cohort). Acquiring data and screening features were performed successively. Totally 1133 radiomics features were extracted from the T2-weight images before and after treatment. Least absolute shrinkage and selection operator regression, recursive feature elimination algorithm, random forest, and minimum-redundancy maximum-relevancy (mRMR) method were used for feature selection. Nomogram discrimination and calibration were evaluated. Harrell’s concordance index (C-index) and receiver operating characteristic (ROC) analyses were applied to appraise the prognostic performance of nomograms. Survival curves were plotted using Kaplan-Meier method.

RESULTS: Integrating independent clinical predictors with pre-treatment and post-treatment radiomics signatures which were calculated in conformity with radiomics features, we established a clinical-and-radiomics nomogram by multivariable Cox regression. Nomogram consisting of 14 pre-treatment and 7 post-treatment selected features has been proved to yield a reliable predictive performance in both training and validation groups. The C-index of clinical-and-radiomics nomogram was 0.953 (all P < 0.05), which was higher than that of clinical (0.861) or radiomics nomograms alone (based on pre-treatment statistics: 0.942; based on post-treatment statistics: 0.944). Moreover, we received Rad-score of pre-treatment named RS1 and post-treatment named RS2 and all were used as independent predictors to divide patients into high-risk and low-risk groups. Kaplan-Meier analysis showed that lower RS1 (less than cutoff value, – 1.488) and RS2 (less than cutoff value, – 0.180) were easier to avoid disease progression (all P < 0.01). It showed clinical benefit with decision curve analysis.

CONCLUSIONS: MR-based radiomics measured the burden on primary tumor before treatment and the tumor regression after chemoradiotherapy, and was used to build a model to predict progression-free survival (PFS) in the stage II-IVA NPC patients. It can also help to distinguish high-risk patients from low-risk patients, thus guiding personalized treatment decisions effectively.

PMID:37041545 | DOI:10.1186/s13014-023-02257-w

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Nevin Manimala Statistics

“If your mother does not teach you, the world will…”: a qualitative study of parent-adolescent communication on sexual and reproductive health issues in Border districts of eastern Uganda

BMC Public Health. 2023 Apr 11;23(1):678. doi: 10.1186/s12889-023-15562-6.

ABSTRACT

BACKGROUND: Adolescents experience a host of sexual and reproductive health (SRH) challenges, with detrimental SRH and socio-economic consequences. These include early sexual debut, sexually transmitted infections including HIV/AIDS, teenage pregnancy, and early childbearing. Parent-adolescent communication about SRH has significant potential to reduce adolescents’ risky sexual behaviors. However, communication between parents and adolescents is limited. This study explored the facilitators and barriers to parent-adolescent communication about sexual and reproductive health.

METHODS: We conducted a qualitative study in the border districts of Busia and Tororo in Eastern Uganda. Data collection entailed 8 Focus Group Discussions comprising of parents, adolescents (10-17 years), and 25 key informants. Interviews were audio-recorded, transcribed, and translated into English. Thematic analysis was conducted with the aid of NVIVO 12 software.

RESULTS: Participants acknowledged the key role parents play in communicating SRH matters; however, only a few parents engage in such discussions. Facilitators of parent-adolescent communication were: having a good parent-child relationship which makes parents approachable and motivates children to discuss issues openly, a closer bond between mothers and children which is partly attributed to gender roles and expectations eases communication, and having parents with high education making them more knowledgeable and confident when discussing SRH issues with children. However, the discussions are limited by cultural norms that treat parent-child conversations on SRH as a taboo, parents’ lack of knowledge, and parents busy work schedules made them unavailable to address pertinent SRH issues.

CONCLUSION: Parents’ ability to communicate with their children is hindered by cultural barriers, busy work schedules, and a lack of knowledge. Engaging all stakeholders including parents to deconstruct sociocultural norms around adolescent SRH, developing the capacity of parents to confidently initiate and convey accurate SRH information, initiation of SRH discussions at early ages, and integrating parent-adolescent communication into parenting interventions, are potential strategies to improve SRH communication between parents and adolescents in high-risk settings such as borders.

PMID:37041536 | DOI:10.1186/s12889-023-15562-6

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The moderating effect of cultural competence educational needs on the relationship between transcultural self-efficacy and cultural competence in Korean public health nurses

BMC Nurs. 2023 Apr 12;22(1):103. doi: 10.1186/s12912-023-01253-5.

ABSTRACT

BACKGROUND: In an increasingly multicultural society, cultural competence and transcultural self-efficacy of public health nurses is important for providing culturally congruent care for client from diverse cultural background. To improv this, it is needed tailored and effective educational program based on the cultural competence educational needs. This study investigated the moderating effect of cultural competence educational needs on the relationship between transcultural self-efficacy and cultural competence.

METHODS: This cross-sectional study recruited 217 public health nurses in Korea using convenience sampling from August 2018 to January 2019. A direct questionnaire was used to collect data. Study variables were analyzed using descriptive statistics, correlation, and the Hayes PROCESS macro (Model 1) moderation model.

RESULTS: The mean scores for transcultural self-efficacy, cultural competence educational needs, and cultural competence were 62.33 ± 11.08, 58.19 ± 15.08, and 97.96 ± 17.09, respectively. Transcultural self-efficacy and cultural competence educational needs were positively associated with cultural competence. In the tested model, cultural competence educational needs had a conditional moderating effect on the relationship between transcultural self-efficacy and cultural competence. The positive association between transcultural self-efficacy and cultural competence was significant at low, medium, and high levels of cultural competence educational needs and stronger for those with high needs.

CONCLUSIONS: Cultural competence educational needs may be an important determinant of cultural competence among public health nurses. To effectively increase cultural competence, transcultural self-efficacy should be increased by education programs tailored by cultural competence educational needs.

PMID:37041535 | DOI:10.1186/s12912-023-01253-5

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Reduction of venous air embolism in coronary computed tomography angiography using a modified method of saline test injection

BMC Med Imaging. 2023 Apr 11;23(1):54. doi: 10.1186/s12880-023-01006-5.

ABSTRACT

OBJECTIVES: This paper analyzed the feasibility of reducing venous air emboli introduced during tube connection in computed tomography angiography (CTA) through a modified method of saline test injection.

METHODS: A total of 386 cases of patients undergoing coronary CTA examination were randomly arranged into a control group (199 patients underwent conventional saline injection before the CTA examination) and a case group (187 patients underwent modified saline injection before the CTA examination). The two groups were compared for the location (Fisher’s exact test), number (χ2 test), and diameter (Mann-Whitney rank sum test) of the air emboli along the inflow direction of contrast agent within the scan.

RESULTS: The occurrence rate was 10.55% in the control group and 3.74% in the case group respectively, with a statistically different significance (P = 0.010). In the case group, there were 7 cases of small-grade venous air emboli. In the control group, there were 15 cases of small-grade venous air emboli and 6 cases of moderate-grade venous air emboli. No cases of large-grade venous air emboli were found in both groups.

CONCLUSIONS: The use of this modified method of saline test injection before CTA examination is able to effectively decrease the occurrence of venous air emboli introduced during tube connection, which has some certain practical significance.

PMID:37041532 | DOI:10.1186/s12880-023-01006-5

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The effect of ultrasound-guided intercostal nerve block on postoperative analgesia in thoracoscopic surgery: a randomized, double-blinded, clinical trial

J Cardiothorac Surg. 2023 Apr 11;18(1):128. doi: 10.1186/s13019-023-02210-8.

ABSTRACT

BACKGROUND: Intercostal nerve block (ICNB) is a very effective analgesic method. We aimed to explore the effect of preemptive analgesia with ultrasound-guided intercostal nerve block on postoperative analgesia in thoracoscopic surgery.

METHODS: 126 patients, aged 18-70 years, with American Society of Anesthesiologists (ASA) physical status I-II and scheduled for thoracoscopic pulmonary resection were enrolled in this study. 119 patients were left for final analysis. Patients were randomly allocated to group ICNB and group CONTROL. Patients in CONTROL group were administered sufentanil with patient-controlled analgesia device after operation In group ICNB, patients received ropivacaine ICNB prior to surgery and patient-controlled analgesia device after operation. The primary outcome is visual analog scale pain score (VAS) at rest at 0,4, 8,16,24,48,72 and 168 h postoperatively and they were compared. Surgical outcomes and rescue analgesia requirement were also recorded.

RESULTS: VAS scores were statistically significantly lower for ICNB group compared to control group at 0, 4, 8, 16, 24 and 48 h postoperatively. The duration of insertion of chest tube in ICBN group was shorter than that in control group, and the difference was statistically significant (4.69 ± 2.14 vs. 5.67 ± 2.86, P = 0.036). The postoperative hospital stay, incidence of nausea and vomiting and postoperative pulmonary infection rate in ICBN group were all lower than those in the control group, but there were no statistical differences. The frequency of rescue analgesia during 48 postoperative hours was different between the two groups (ICNB vs. Control; 9.83% vs. 31.03%, P = 0.004).

CONCLUSIONS: For patients undergoing thoracoscopic surgery, ultrasound-guided ICNB is simple, safe, and effective for providing acute postoperative pain management during the early postoperative stage.

TRIAL REGISTRATION: Chinese clinical trials: chictr.org.cn, ChiCTR1900021017. Registred on 25/01/2019.

PMID:37041525 | DOI:10.1186/s13019-023-02210-8