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The Development of Therapeutic Radiographers in Imaging and Adaptive Radiotherapy Through Clinical Trial Quality Assurance

Clin Oncol (R Coll Radiol). 2021 Mar 22:S0936-6555(21)00052-2. doi: 10.1016/j.clon.2021.02.009. Online ahead of print.

ABSTRACT

AIMS: Adaptive radiotherapy (ART) is an emerging advanced treatment option for bladder cancer patients. Therapeutic radiographers (RTTs) are central to the successful delivery of this treatment. The purpose of this work was to evaluate the image-guided radiotherapy (IGRT) and ART experience of RTTs before participating in the RAIDER trial. A plan of the day (PoD) quality assurance programme was then implemented. Finally, the post-trial experience of RTTs was evaluated, together with the impact of trial quality assurance participation on their routine practice.

MATERIALS AND METHODS: A pre-trial questionnaire to assess the experience of the RTT staff group in IGRT and ART in bladder cancer was sent to each centre. Responses were grouped according to experience. The PoD quality assurance programme was implemented, and the RAIDER trial commenced. During stage 1 of the trial, RTTs reported difficulties in delivering PoD and the quality assurance programme was updated accordingly. A follow-up questionnaire was sent assessing experience in IGRT and ART post-trial. Any changes in routine practice were also recorded.

RESULTS: The experience of RTTs in IGRT and ART pre-trial varied. For centres deemed to have RTTs with more experience, the initial PoD quality assurance programme was streamlined. For RTTs without ART experience, the full quality assurance programme was implemented, of which 508 RTTs completed. The quality assurance programme was updated (as the trial recruited) and it was mandated that at least one representative RTT (regardless of pre-trial experience) participated in the update in real-time. The purpose of the updated quality assurance programme was to provide further support to RTTs in delivering a complex treatment. Engagement with the updated quality assurance programme was high, with RTTs in 24/33 centres participating in the real-time online workshop. All 33 UK centres reported all RTTs reviewed the updated training offline. Post-trial, the RTTs’ experience in IGRT and ART was increased.

CONCLUSION: Overall, 508 RTTs undertook the PoD quality assurance programme. There was a high engagement of RTTs in the PoD quality assurance programme and trial. RTTs increased their experience in IGRT and ART and subsequently updated their practice for bladder cancer and other treatment sites.

PMID:33766503 | DOI:10.1016/j.clon.2021.02.009

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Advancing Radiotherapy for Bladder Cancer: Randomised Phase II Trial of Adaptive Image-guided Standard or Dose-escalated Tumour Boost Radiotherapy (RAIDER)

Clin Oncol (R Coll Radiol). 2021 Mar 22:S0936-6555(21)00055-8. doi: 10.1016/j.clon.2021.02.012. Online ahead of print.

NO ABSTRACT

PMID:33766502 | DOI:10.1016/j.clon.2021.02.012

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Screening for delirium in the intensive care unit using eDIS-ICU – A purpose-designed app: A pilot study

Aust Crit Care. 2021 Mar 22:S1036-7314(20)30368-4. doi: 10.1016/j.aucc.2020.12.008. Online ahead of print.

ABSTRACT

INTRODUCTION: Delirium, a common complication of an intensive care unit (ICU) admission, is inconsistently diagnosed by clinicians. Current screening tools require specialist expertise and/or training. Some are time-consuming to administer, and reliability in routine clinical practice is questionable. An innovative app designed to enable efficient and sensitive screening for delirium without specialist training (eDIS-ICU) has recently been described. This pilot study compared the eDIS-ICU against the reference standard expert assessment using DSM-V (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) criteria and the Confusion Assessment Method for the ICU (CAM-ICU).

METHODS: In this prospective, single-centre pilot study, a convenience sample of 29 ICU patients were recruited at a tertiary referral hospital between November 2018 and August 2019. After obtaining written consent, demographic and clinical data were collected, and the patients were screened for delirium using eDIS-ICU and CAM-ICU by two clinician researchers in random order. The patients were also assessed for presence of delirium independently by an expert clinician using a structured interview to diagnose as per DSM-V criteria. The results of screening and diagnosis were tabulated to allow comparison of screening tools against diagnosis; sensitivity and specificity of the tools were calculated.

RESULTS: Seven participants were diagnosed with delirium as per DSM-V criteria. The eDIS-ICU tool correctly identified six of these participants compared with two identified by CAM-ICU. The sensitivity of the eDIS-ICU tool was 86% (95% confidence interval [CI] = 81.5-100.0) compared with 29% (95% CI = 5.1-69.7) for CAM-ICU (p < 0.05), and the specificity was 73% (95% CI = 81.5-100.0) versus 96% (95% CI = 75.1-99.8), respectively.

CONCLUSION: The simple and novel eDIS-ICU delirium screening tool was noninferior to the CAM-ICU in detecting delirium as per DSM-V criteria. A definitive validation study is warranted.

PMID:33766486 | DOI:10.1016/j.aucc.2020.12.008

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Primary vs redo robotic pyeloplasty: A comparison of outcomes

J Pediatr Urol. 2021 Feb 19:S1477-5131(21)00098-X. doi: 10.1016/j.jpurol.2021.02.016. Online ahead of print.

ABSTRACT

INTRODUCTION: Robot-assisted laparoscopic pyeloplasty (RALP) is a safe and efficacious option for repair of UPJO. We hypothesize that redo-RALP is technically more difficult but has comparable outcomes to primary RALP.

METHODS: An IRB-approved single institutional registry was utilized to identify all patients undergoing primary or redo RALP from 2012 to 2019. Redo RALP consisted of pyeloplasty and ureterocalicostomy (RALUC). Peri-operative and post-operative details and outcomes were aggregated. Successful reconstruction was defined as resolution of symptoms, improved hydronephrosis and no need for additional procedures.

RESULTS: From 399 patients who underwent UPJO repair at our center, a total of 306 with a median age of 4.9 years at surgery and a median follow-up of 18.5 months were included: 276 primary and 30 redo (21 RALP and 9 RALUC). Redo group had significantly longer procedure time and length of stay compared to the primary group. However, no significant difference was noted in the post-operative complications, need for additional endoscopic procedures or redo reconstruction, and success between the two groups. Multivariate analysis showed that when controlled for age, gender, 30-days post-operative complication and anatomy of obstruction, redo as compared to primary reconstruction did not have a significant effect on success.

DISCUSSION: This study is the largest controlled cohort in the pediatric population comparing redo RALP with an established control group -primary RALP. This retrospective chart review possesses the biases innate to any retrospective study. The low number of re-operative cases as well as low rate of failure in redo RALP further complicates identification of statistically significant predictors of outcomes following redo RALP.

CONCLUSION: Redo RALP is an efficient and safe approach for reconstruction of recurrent UPJO, with low complication rate and high success rate, comparable to primary RALP.

PMID:33766473 | DOI:10.1016/j.jpurol.2021.02.016

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Prospective randomized controlled study on clinical effects of autologous skin paste in repairing medium-thickness skin donor site wounds

Zhonghua Shao Shang Za Zhi. 2021 Mar 20;37(3):232-236. doi: 10.3760/cma.j.cn501120-20200304-00121.

ABSTRACT

Objective: To explore the clinical effects of autologous skin paste in repairing medium-thickness skin donor site wounds. Methods: The prospective randomized controlled research method was applied. From October 2018 to December 2019, 18 patients with flame burn or hydrothermal scald, conforming to the inclusion criteria were admitted to Jinhua Hospital Affiliated to Zhejiang University School of Medicine, including 15 males and 3 females, aged (45±6) years. The wounds were repaired with medium-thickness skin grafts from thigh, and the wound area was (121±33) cm2 after medium-thickness skin grafting. The medium-thickness skin donor site wound in each patient was divided into 2 wounds in equal area and allocated into autologous skin paste group and conventional treatment group by flipping a coin, with 18 wounds in each group. The wounds in autologous skin paste group were repaired with skin paste prepared with remaining skin fragments after autologous medium-thickness skin grafting, and the wounds in conventional treatment group were covered with petroleum jelly gauze and fixed with sterile gauze. On 3, 7, 14, and 21 d after operation, the wound healing in 2 groups was observed, and the wound healing rate was calculated. The wound healing time in 2 groups was recorded. Occurrences of wound subcutaneous effusion and infection on 3, 7, 14, and 21 d after operation and wound ulceration in 3 months after operation were observed. In 6 months after operation, the Vancouver Scar Scale (VSS) was used to evaluate the scar formation of wounds in 2 groups. Data were statistically analyzed with analysis of variance for repeated measurement, chi-square test, and group t test. Results: The wounds in 2 groups did not heal on 3 and 7 d after operation. The wound healing rate in autologous skin paste group was (29.8±2.5)% and (95.6±4.7)% on 14 and 21 d after operation, which were significantly higher than (25.8±2.9)% and (82.6±8.9)% in conventional treatment group (t=4.3, 5.6, P<0.01). The wound healing time in autologous skin paste group was (21.8±1.6) d, which was significantly shorter than (25.6±2.0) d in conventional treatment group (t=6.24, P<0.01). On 3, 7, 14, and 21 d after operation, there were no complications such as subcutaneous effusion or infection in wounds of 2 groups. In 3 months after operation, ulceration occurred in wounds of 2 patients in autologous skin paste group, which was significantly less than 12 patients in conventional treatment group (χ2=11.688, P<0.01). The ulcerated wounds healed after dressing changes. In 6 months after operation, the VSS score of wounds in autologous skin paste group was (9.1±1.1) points, which was significantly lower than (11.3±1.2) points in conventional treatment group (t=-5.75, P<0.01). Conclusions: The remaining skin fragments after autologous medium-thickness skin grafting prepared into skin paste to repair medium-thickness skin donor site wounds can shorten wound healing time, improve wound healing quality, and reduce degree of scar hyperplasia, with a good clinical effect.

PMID:33765725 | DOI:10.3760/cma.j.cn501120-20200304-00121

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Correlation analysis of Ki67, Ck19 with clinicopathological features and apparent diffusion coefficient value of hepatocellular carcinoma

Zhonghua Yi Xue Za Zhi. 2021 Mar 23;101(11):798-802. doi: 10.3760/cma.j.cn112137-20210108-00058.

ABSTRACT

Objective: To investigate the expression of cell proliferating nuclear antigen (Ki67) and cytokeratin 19 (Ck19) in hepatocellular carcinoma (HCC), and correlation with the clinicopathological features and apparent diffusion coefficient (ADC) value of hepatocellular carcinoma. Methods: The data of 203 newly diagnosed HCC patients in the Affiliated Cancer Hospital of Zhengzhou University from January 2014 to October 2019 were retrospectively collected, and the expression of Ki67 and Ck19 and ADC values in all patients were analyzed. The relationship between Ki67 and Ck19 and the clinical pathological characteristics of the patient, and calculate the difference and correlation with the ADC value was analyzed. Results: There were statistically significant differences in tumor vascular tumor thrombus, alpha-fetoprotein (AFP), postoperative tumor recurrence, lymph node metastasis, and HCC differentiation between Ki67 positive and negative groups (χ²=5.156, 12.741, 29.925, 3.963, 77.408, all P<0.05),and negatively correlated with ADC value (r=-0.214, P=0.002). The average ADC value of HCC in the low Ki67 group was significantly higher than that of the high Ki67 group (1 089±280 vs 1 009±212, P<0.05). There were statistically significant differences in tumor vascular tumor thrombus, AFP, postoperative tumor recurrence, and lymph node metastasis between Ck19 positive and negative groups (χ²=9.058, 27.034, 4.053, 14.187, all P<0.05), but not correlated with ADC value (r=0.062, P=0.380). The expression differences of Ki67 and Ck19 in different HCC recurrence time groups were statistically significant (P<0.05). Conclusion: The positive expression of Ki67 and Ck19 in HCC was associated with the prognosis and recurrence of HCC. CK19 was not correlated with the ADC value, while Ki67 was negatively correlated with the ADC value, indicating that ADC value could provide certain imaging information for the biological characteristics of preoperative HCC.

PMID:33765721 | DOI:10.3760/cma.j.cn112137-20210108-00058

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Analysis of perioperative blood loss of posterior lumbar interbody fusion on lumbar spondylolisthesis in patients with rheumatoid arthritis

Zhonghua Yi Xue Za Zhi. 2021 Mar 23;101(11):792-797. doi: 10.3760/cma.j.cn112137-20201009-02791.

ABSTRACT

Objective: To compare the intraoperative blood loss, postoperative drainage and hidden blood loss (HBL) in lumbar posterior lumbar interbody fusion (PLIF) in patients with and without rheumatoid arthritis (RA), and analyze the relevant factors of HBL in RA patients. Methods: Fifty patients with RA (RA group) and 73 patients without RA (NRA group) treated in the Heze Municipal Hospital from January 2014 to April 2019 were enrolled in this study. The basic information, RA information, operation and related blood loss indicators in the two groups were compared. The intraoperative blood loss, postoperative drainage and HBL were the main results. The secondary results were operation time, preoperative and postoperative hematocrit (Hct) and hemoglobin (Hb) and their variation values, cases of anemia before and after surgery, number of new anemia after surgery, autologous blood and allogeneic blood transfusion, etc. The correlation factors of HBL in RA group were analyzed by multi-linear regression model. Results: There were 9 males and 41 females with a mean age of (62±7) years in RA group; and 11 males and 62 females with a mean age of (64±9) years in NRA group. The course of disease in RA group was (14.4±11.2) years, the most common anti-rheumatism drug (DMARDs) were single-drug and combined oral. There was no significant differences between the two groups in the number of vertebral bow screws and intervertebral fusion device. The incidence of surgical complications was comparable between the two groups. Differences between the two groups in total blood loss (TBL), intraoperative blood loss, and postoperative drainage were not statistically significant ((693±315) ml vs (630±365) ml, (454±373) ml vs (414±375) ml and (653±376) ml vs (675±400) ml, t=1.072, 0.388, -0.189, all P>0.05), while the HBL and the percentage of HBL in TBL were lower in the NRA group (t=6.157, 2.965, both P<0.05). According to the layered analysis of the number of surgical segments, the proportion of HBL and the HBL percentage of TBL in the NRA group for the long section (≥3 segments) surgery were better than those in the RA group. The Hct changing value was larger in the RA group than that in the NRA group (P=0.031). However, the difference of Hb reduction between the two groups was not statistically significant (P>0.05). There was no significant difference in anemia and exacerbation of anemia after surgery, allogeneic blood transfusion and the operation duration between the two groups (all P>0.05). A multi-linear regression analysis of HBL showed that higher RA’s Steinbrocker grading, did not take DMARDS, Hb changes and infusion of allogeneic blood were independently correlated to HBL (β=0.363, -0.272, 0.210, 1.204, all P<0.05). Conclusions: There is no difference in TBL, intraoperative blood loss, postoperative drainage and operation duration between the RA and NRA group, while HBL and the proportion of HBL in the TBL are higher in the RA group. The RA group has higher Steinbrocker rating, no DMRDs and more Hb changes.

PMID:33765720 | DOI:10.3760/cma.j.cn112137-20201009-02791

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The influence of XRCC1 gene polymorphism on the prognosis and safety of stage Ⅲ patients with colorectal cancer who received oxaliplatin based adjuvant chemotherapy

Zhonghua Yi Xue Za Zhi. 2021 Mar 23;101(11):759-765. doi: 10.3760/cma.j.cn112137-20200708-02061.

ABSTRACT

Objective: To investigate the influence of X-ray repair cross complementing 1 (XRCC1) gene polymorphism on the prognosis and safety of stage Ⅲ patients with colorectal cancer (CRC) who received oxaliplatin based adjuvant chemotherapy. Methods: A total of 218 stage Ⅲ patients with CRC after R0 resection and received oxaliplatin based adjuvant chemotherapy in the department of gastrointestinal surgery of the First Affiliated Hospital of Zhengzhou University from March 2012 to December 2019 were included and the baseline characteristics were collected. There were 125 male and 93 female patients, aged from 18 to 78 years. Peripheral blood and peripheral blood mononuclear cell (PBMC) specimens of the colorectal cancer patients were preserved for genotyping of XRCC1 gene genetic variation and mRNA expression of XRCC1, respectively. The association between genotype status and prognosis was analyzed by Kaplan-Meier survival analysis. And the correlation between genotype status and adverse reactions was performed with χ2 test. Results: The median follow-up time were 4.9 (0.3-7.3) years. The median disease-free survival (DFS) of the 218 patients with CRC was 4.4 years and the median overall survival (OS) was 5.5 years. The prevalence of rs1799782 in XRCC1 gene among the 218 patients was: GG genotype 62.4% (136/218), GA genotype 33.0% (72/218) and AA genotype 4.6% (10/218), minor allele frequency was 0.21. And the distribution frequencies of the three genotypes were in accordance with the hardy-weinberg equilibrium (P=0.905). GA and AA genotypes were merged in the subsequent analysis. The median DFS [M (95%CI)] of GG genotype and GA/AA genotype was 5.2 (4.5-5.9) years and 3.8 (3.2-4.4) years, which was statistically significant (χ²=6.943, P=0.008). Furthermore, the median OS [M (95%CI)] of the two genotypes were 6.0 (5.3-6.7) years and 4.5 (3.9-5.1) years, which was statistically significant (χ²=5.538, P=0.010). The mRNA expression of XRCC1 in PBMC of the patients with GA/AA genotypes was 3.8±0.6,which was significantly higher than that of the GG genotype patients(2.8±0.7) (t=6.140, P<0.001). Conclusion: The prognosis of patients with CRC who received oxaliplatin based adjuvant chemotherapy may be influenced by XRCC1 rs1799782 through mediating the mRNA expression of XRCC1.

PMID:33765714 | DOI:10.3760/cma.j.cn112137-20200708-02061

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Serum kisspeptin levels in polycystic ovary syndrome: A meta-analysis

J Obstet Gynaecol Res. 2021 Mar 25. doi: 10.1111/jog.14767. Online ahead of print.

ABSTRACT

AIM: To clarify the association of serum kisspeptin levels in women with polycystic ovary syndrome (PCOS) by meta-analysis.

METHODS: Two English databases and two Chinese databases were searched for the relationship between kisspeptin and PCOS published from 2009. After the studies screening according to specific principles, we used STATA 12.0 for meta-analysis. Standardized mean difference (SMD) and its 95% confidence intervals (95% CIs) were used as the effect size and STATA 12.0 software was performed by this meta-analysis.

RESULTS: Nine articles were included in the end, with a total of 1282 participants (699 patients and 583 controls). Heterogeneity between studies was statistically significant. Therefore, the random effects model was used to combine the effects. Meta-analysis showed statistically significant differences in serum kisspeptin levels between the PCOS patients and controls (SMD = 0.57, 95% CI [0.32, 0.82]), which indicated that there is a strong association between serum kisspeptin levels and PCOS. The source of high heterogeneity between the inclusion studies (I2 = 73.2%) might be due to the small sample size. The larger variation of kisspeptin concentration might be caused by different diagnosis criteria of PCOS and short half-time period of kisspeptin combined with nonstandard testing process.

CONCLUSION: Serum kisspeptin levels in PCOS patients were higher than non-PCOS patients. It is a hint to indicate us that kisspeptin might be an independent biomarker of PCOS patients.

PMID:33765692 | DOI:10.1111/jog.14767

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Comparative Effectiveness of the Homeopathic Preparation Traumeel S in Third Molar Extraction Surgery: A Preliminary Triple-Blind Clinical Trial

Homeopathy. 2021 Mar 25. doi: 10.1055/s-0041-1725038. Online ahead of print.

ABSTRACT

BACKGROUND AND AIM: This preliminary study aimed to evaluate whether a homeopathic preparation (Traumeel S) might be a good option to control post-operative outcomes (pain, edema and trismus) associated with surgical removal of mandibular third molar teeth. The null hypothesis was that Traumeel S is not different from dexamethasone (gold standard) in controlling these post-operative inflammatory complications.

METHODS: A randomized, “split-mouth”, triple-blind clinical trial was conducted. Seventeen healthy patients with a mean age of 20.94 ( ± 5.83) years had their lower asymptomatic bilateral third molars removed. Patients were randomized to receive Traumeel S or dexamethasone pre-operatively by injection into the masseter muscle; each patient acted as his/her own control. At 24, 48, 72 hours and 7 days after the surgery, the pain was evaluated according to a visual analog scale, edema through linear measurements of the face, and trismus through the maximum buccal opening. Wilcoxon statistics or paired t-test were used, and a significance level of 95% was adopted.

RESULTS: For pain, the results for Traumeel S were not different (p > 0.05) from those of dexamethasone after 24 hours, 72 hours, and 7 days. For edema, the results for Traumeel S were not different (p > 0.05) from those of dexamethasone at all post-operative evaluations. For mouth opening, the results for Traumeel S were not different (p > 0.05) from those of dexamethasone at 72 hours and 7 days after third molar extraction.

CONCLUSION: With the exception of some early post-operative findings, the null hypothesis is not rejected. Traumeel S might be a good alternative approach to dexamethasone for controlling pain, edema and trismus after third molar removal.

PMID:33765688 | DOI:10.1055/s-0041-1725038