High-quality Evidence Research Articles

Tip bendable suction ureteral access sheath versus traditional sheath in retrograde intrarenal stone surgery: an international multicentre, randomized, parallel group, superiority study

Retrograde intrarenal surgery (RIRS) is the main treatments for upper urinary tract stones. The Ureteral Access Sheath (UAS) serves as a supplementary tool, facilitating direct kidney access during RIRS. High quality of evidence comparing tip bendable suction ureteral access sheath (S-UAS) with traditional UAS in RIRS for the treatment of renal and ureteral stones is lacking. The purpose of the study is to compare the efficacy and safety of S-UAS with traditional UAS in RIRS for the treatment of renal or ureteral stones ≤30mm. An international, multicenter, and superiority randomized controlled trial included 320 intention-to-treat patients across 8 medical centers in China, the Philippines, Malaysia and Turkey from August 2023 to February 2024. The inclusion criteria were patients ≥18 years old with renal or ureteral stones ≤30mm. RIRS was performed using either S-UAS or traditional UAS. The primary outcome was the immediately stone-free rate (SFR). Secondary outcomes included SFR 3 months after operation, operating time, hospital stay, auxiliary procedures, complications (using the Clavien-Dindo grading system), and improvement in the Quality of Life (QoL) score. Differences between proportions [risk difference (RD)]/means [mean difference (MD)] and 95% confidence intervals (CI) were presented. This study is registered at ClinicalTrials.gov: NCT05952635. The S-UAS group demonstrated a significantly higher immediately SFR (81.3% versus 49.4%; RD 31.9%; 95% CI 22.5%-41.7%; p=0.004) compared to the traditional UAS group, as determined by the one-side superiority test. Additionally, the S-UAS group exhibited a higher SFR at 3 months post-operation (87.5% versus 70.0%; RD 17.5%; 95% CI 8.7%-26.3%; p<0.001), lower postoperative fever rate (RD-11.9%; 95% CI-18.7% to-4.9%; p<0.001), reduced use of stone baskets (RD-70.6%; 95% CI-77.8% to-63.5%; p<0.001), and better QoL improvement (MD 7.25; 95% CI 2.21-12.29; p=0.005). No statistically significant differences were observed in operation time, hospital stay, or the need for second-stage RIRS. In RIRS for upper urinary tract stones ≤30mm, S-UAS exhibited superior performance compared to traditional UAS, demonstrating higher SFR, reduced postoperative fever rate, and improved QoL outcomes. S-UAS emerges as a prudent and advantageous alternative to traditional UAS for RIRS. National Natural Science Foundation of China and Guangdong Province, and Zhejiang Medicine and Health Program.

Yiqi Wenyang Jiedu prescription for preventing and treating postoperative recurrence and metastasis of gastric cancer: a randomized controlled trial protocol.

Postoperative recurrence and metastasis of gastric cancer (GC) are primary factors that contribute to poor prognosis. GC recurs at a rate of approximately 70%-80% within 2 years after local treatment and approximately 90% within 5 years. "Yang-deficient toxic node" is the core pathogenesis of GC recurrence and metastasis. The Yiqi Wenyang Jiedu prescription (YWJP), a form of complementary and alternative medicine in China, is an empirical remedy to prevent postoperative recurrence and metastasis of GC. Taking the main therapeutic principles of "nourishing Qi and warming Yang, strengthening Zhengqi, and detoxifying" can aid in preventing the recurrence and metastasis of GC in patients during the watchful waiting period after surgery and adjuvant chemotherapy. This approach aims to enhance the quality of life of patients. However, high-quality evidence to support this hypothesis is lacking. This study will aim to investigate the efficacy and safety of YWJP to prevent and treat postoperative metastasis and GC recurrence. The study will be a multicenter, randomized, double-blind, placebo-parallel-controlled clinical trial. A total of 212 patients who completed adjuvant chemotherapy within 8 months of radical gastrectomy will be enrolled. Patients in the intervention group will receive the YWJP, whereas those in the control group will receive a placebo. The main outcome was the disease-free survival (DFS) rate 2 years after surgery. The secondary outcomes included DFS time, overall survival, annual cumulative recurrence and rate of metastasis after 1-3 years, cumulative annual survival after 1-3 years, fat distribution-related indicators, tumor markers, peripheral blood inflammatory indicators, prognostic nutritional index, symptoms and quality of life evaluation, medication compliance, and adverse reaction rate. There is a lack of effective therapy after the completion of adjuvant therapy during the postoperative period of watchful waiting. This study will be the first randomized clinical trial to evaluate whether complementary and alternative medical interventions can effectively prevent recurrence and metastasis during the watchful waiting period after GC surgery and to provide evidence for surveillance treatment management after GC surgery. ClinicalTrials.gov, identifier NCT05229809.

Caesarean section and anal incontinence in women after obstetric anal sphincter injury: A systematic review and meta-analysis.

Approximately 50% women who give birth after obstetric anal sphincter injury (OASI) develop anal incontinence (AI) over their lifetime. To evaluate current evidence for a protective benefit of planned caesarean section (CS) to prevent AI after OASI. MEDLINE/PubMed, Embase 1974-2024, CINAHL and Cochrane to 7 February 2024 (PROSPERO CRD42022372442). All studies reporting outcomes after OASI and a subsequent birth, by any mode. Eighty-six of 2646 screened studies met inclusion criteria, with nine studies suitable to meta-analyse the primary outcome of 'adjusted AI' after OASI and subsequent birth. Subgroups: short-term AI, long-term AI, AI in asymptomatic women. total AI, quality of life, satisfaction/regret, solid/liquid/flatal incontinence, faecal urgency, AI in women with and without subsequent birth, change in AI pre- to post- subsequent birth. There was no evidence of a difference in adjusted AI after subsequent vaginal birth compared with CS after OASI across all time periods (OR = 0.92, 95% CI 0.72-1.20; 9 studies, 2104 participants, I2 = 0% p = 0.58), for subgroup analyses or secondary outcomes. There was no evidence of a difference in AI in women with or without subsequent birth (OR = 1.00 95% CI 0.65-1.54; 10 studies, 970 participants, I2 = 35% p = 0.99), or pre- to post- subsequent birth (OR = 0.79 95% CI 0.51-1.25; 13 studies, 5496 participants, I2 = 73% p = 0.31). Due to low evidence quality, we are unable to determine whether planned caesarean is protective against AI after OASI. Higher quality evidence is required to guide personalised decision-making for asymptomatic women and to determine the effect of subsequent birth mode on long-term AI outcomes.

Perioperative Naltrexone Management: A Scoping Review by the Perioperative Pain and Addiction Interdisciplinary Network.

Substance use disorders, including alcohol use disorder, are a public health concern that affect more than 150 million people globally. The opioid antagonist naltrexone is being increasingly prescribed to treat opioid use disorder, alcohol use disorder, and chronic pain. Perioperative management of patients on naltrexone is inconsistent and remains a controversial topic, with mismanagement posing a significant risk to the long-term health of these patients. This scoping review was conducted to identify human studies in which the perioperative management of naltrexone was described. This review includes a systematic literature search involving Medline, Medline In-Process, Embase, PsycINFO, and Web of Science. Seventeen articles that describe perioperative naltrexone management strategies were included, including thirteen guidelines, one case report, and three randomized trials. Despite its use in patients with alcohol use disorder and chronic pain, no clinical studies, case reports, or guidelines addressed naltrexone use in these clinical populations. All of the guideline documents recommended the preoperative cessation of naltrexone, irrespective of dose, indication, or route of administration. None of these guideline documents were designed on the basis of a systematic literature search or a Delphi protocol. As described by the primary studies, perioperative pain relief varied depending on naltrexone dose and route of administration, time since last naltrexone administration, and underlying substance use disorder. None of the studies commented on the maintenance of recovery for the patient's substance use disorder in the context of perioperative naltrexone management. The current understanding of the risks and benefits of continuing or stopping naltrexone perioperatively is limited by a lack of high-quality evidence. In patients with risk factors for return to use of opioids or alcohol, the discontinuation of naltrexone should have a strong rationale. Future studies and guidelines should seek to address both acute pain management and maintaining recovery when discussing perioperative naltrexone management strategies.

Inferior vena cava ultrasound to predict hypotension after general anesthesia induction: a systematic review and meta-analysis of observational studies.

Hypotension after induction of general anesthesia is common and is associated with significant adverse events. Identification of patients at high risk can inform the use of preoperative mitigation strategies. We conducted a systematic review and meta-analysis to assess the diagnostic accuracy of the inferior vena cava collapsibility index (IVC-CI) and maximal diameter (dIVCmax) in predicting postinduction hypotension and to identify their predictive performance across different threshold ranges. We searched MEDLINE, PubMed®, and Embase from inception to March 2023 for prospective observational studies exploring the performance of IVC-CI and dIVCmax in predicting postinduction hypotension in adults presenting for elective surgery under general anesthesia. We excluded studies reporting on IVC parameters predicting postinduction hypotension in the obstetric patient population or exclusively in patients with obesity. Trials screening and data extraction were conducted independently. We performed meta-analyses to identify the performance of IVC parameters in predicting postinduction hypotension, followed by subgroup analyses that sought the IVC-CI range with the highest hierarchical summary receiver-operating characteristic area under the curve (HSROC-AUC). We used a bivariate random effects model to calculate summary estimates. We evaluated study quality using Newcastle-Ottawa scores and certainty of evidence using the GRADE framework. We included 14 studies involving 1,166 patients. Pooled sensitivity and specificity of the IVC-CI to predict postinduction hypotension was 0.68 (95% confidence interval [CI], 0.55 to 0.79; coverage probability, 0.91) and 0.78 (95% CI, 0.69 to 0.85; coverage probability, 0.9), respectively, with an HSROC-AUC of 0.80 (95% CI, 0.68 to 0.85, high quality of evidence). An IVC-CI threshold range of 40-45% had an HSROC-AUC of 0.86 (95% CI, 0.69 to 0.93, high quality of evidence). Preoperative IVC-CI is a strong predictor of postinduction hypotension. We recommend that future studies use an IVC-CI threshold of 40-45% (low certainty of evidence). Future studies are needed to establish whether ultrasound-guided preoperative optimization improves outcomes in high-risk patients. PROSPERO ( CRD42022316140 ); first submitted 10 March 2022.

Management of Massive Irreparable Posterosuperior Cuff Tears: A Systematic Review for Clinical &amp; Functional &amp; Radiological Outcomes

Abstract Background The management of massive irreparable cuff tears (MIRCT) remains a highly controversial subject with many possible surgical and non-surgical interventions and no clear evidence regarding the most effective and beneficial intervention. Different management options include: conservative management, partial repair, tendon transfer, superior capsular reconstruction, subacromial spacer insertion, reverse total shoulder arthroplasty (RTSA). Aim of the Work The aim of this systematic review is to compare the various methods of management of posterosuperior cuff tears without arthropathy to reach the most effective and sustainable mode of management. Patients and Methods A randomized controlled trial, non-randomized clinical trials, prospective and retrospective comparative cohort studies and case series. We will exclude cross-sectional studies, case reports and literature not in English. Results There is no high quality evidence on management of MIRCT. There was no Level I or II evidence. We included 69 papers that studied different modalities of management of MIRCT, 31 of level III and the remaining were of level IV evidence. Consequently, it’s still difficult to recommend one method of management over the other regarding the management of irreparable cuff tears. Patient age, demands, expectations, thorough clinical examination, surgeon experience and preference are still a major deciding factor when choosing and appropriate method. Conclusion Due to the unavailability of high-quality clinical studies available for guiding management of irreparable MRCT, it is consequently not possible to recommend for or against any specific treatment strategy. Rather, clinical experience, patient factors, patient expectations, and rotator cuff tear characteristics should guide clinical decision-making. Physical therapy compared to surgical treatments may have inferior outcomes. Standardized data collection, reporting and terminology are key to enhancing the quality of evidence-based medicine.

O-319 A randomised trial of time-lapse imaging of embryos in in-vitro-fertilisation treatment

Abstract Study question Do time-lapse imaging (TLI) systems used in IVF/ICSI treatment improve live birth either due to undisturbed culture conditions or improved embryo selection or both? Summary answer In women undergoing IVF/ICSI treatment the use of TLI systems does not significantly increase the odds of live birth compared to standard care without TLI. What is known already TLI systems used in IVF treatment have the potential to improve fertility outcomes either due to undisturbed culture conditions or improved embryo selection or both. However, there remains uncertainty about its benefits. Existing reviews and primary studies predominantly report no differences between the use of TLI and conventional methods. However none of the previous trials were adequaltely powered to detect meaningful differences in live birth and the quality of most trials was deemed to be low to very low. Study design, size, duration TILT (Time-lapse Imaging Trial) is a multi-centre, three-arm, parallel-group, double-blind, randomised controlled trial. Participants were randomly assigned in a 1:1:1 ratio to the TLI system for both undisturbed culture and embryo selection (TLI arm), TLI system for undisturbed culture conditions alone (undisturbed culture arm), and standard care without TLI (control arm). From June 2018 to September 2022, we randomised 1575 participants based on a pre-specified sample size to detect an 8.75% difference in live births. Participants/materials, setting, methods We randomised 1575 couples undergoing IVF/ICSI with broad inclusion criteria across seven IVF centres. The primary outcome was live birth. Secondary outcomes included clinical pregnancy, pregnancy loss, and multiple pregnancy. Primary analysis was performed based on the intention-to-treat principle for all participants with primary outcome data available and the effect estimate reported as an adjusted odds ratio (aOR). Pre-specified sensitivity analyses and subgroup analyses for age and method of embryo transfer were performed. Main results and the role of chance We recruited 2191 and randomised 1575 participants. Live birth data were available for 1558/1575 (98.92%) participants. The livebirth rates were 33.7% (175/520) in the TLI arm, 36.6% (189/516) in the undisturbed culture arm and 33.0% (172/522) in the control arm. The aOR was 1.04 (97.5% confidence interval (CI) 0.73 to 1.47) for TLI arm vs control and 1.20 (97.5% CI 0.85 to 1.70) for undisturbed culture vs control. The clinical pregnancy rates were 42.2% (219/519) in the TLI arm, 43.4% (225/518) in the undisturbed culture arm, and 40.9% (212/519) in the control arm. There were no significant differences for TLI vs control arm (aOR 1.06, 95% CI 0.82-1.38) and undisturbed culture vs control arm (aOR 1.11, 95% CI 0.86-1.46). The rates of pregnancy loss between clinical pregnancy and 24 weeks’ gestation were not statistically different when TLI (8.7%, 45/515) and undisturbed culture arms (6.4%, 33/513) were compared with control arm (8.1%, 42/517) with aOR 1.09 (95% CI 0.66-1.77) and 0.76 (95% CI 0.45-1.29) respectively. None of the other secondary outcomes demonstrated significant differences between the arms The findings were similar irrespective of the woman’s age and use of fresh or frozen embryo replacement, and for all sensitivity analyses, for primary and secondary outcomes. Limitations, reasons for caution Although the trial recruitment was delayed by the SARS-CoV-2 pandemic, this did not impact the results as patient populations, clinical care pathways and time-lapse technology remained similar. The remit of this trial did not allow assessment of the influence of TLI systems on embryology laboratory workflow or perform a health-economic analysis. Wider implications of the findings Our trial provides high-quality definitive evidence of no benefit of the use of TLI systems for embryo incubation and selection to improve success rates in women having IVF and ICSI treatment. Trial registration number ISRCTN17792989

Hydroxyurea to prevent brain injury in children with sickle cell disease (HU Prevent)-A randomized, placebo-controlled phase II feasibility/pilot study.

Central nervous system (CNS) injury is common in sickle cell disease (SCD) and occurs early in life. Hydroxyurea is safe and efficacious for treatment of SCD, but high-quality evidence from randomized trials to estimate its neuroprotective effect is scant. HU Prevent was a randomized (1:1), double-blind, phase II feasibility/pilot trial of dose-escalated hydroxyurea vs. placebo for the primary prevention of CNS injury in children with HbSS or HbS-β0-thalassemia subtypes of SCD age 12-48 months with normal neurological examination, MRI of the brain, and cerebral blood flow velocity. We hypothesized that hydroxyurea would reduce by 50% the incidence of CNS injury. Two outcomes were compared: primary-a composite of silent cerebral infarction, elevated cerebral blood flow velocity, transient ischemic attack, or stroke; secondary-a weighted score estimating the risk of suffering the consequences of stroke (the Stroke Consequences Risk Score-SCRS), based on the same outcome events. Six participants were randomized to each group. One participant in the hydroxyurea group had a primary outcome vs. four in the placebo group (incidence rate ratio [90% CI] 0.216 [0.009, 1.66], p = .2914) (~80% reduction in the hydroxyurea group). The mean SCRS score was 0.078 (SD 0.174) in the hydroxyurea group, 0.312 (SD 0.174) in the placebo group, p = .072, below the p-value of .10 often used to justify subsequent phase III investigations. Serious adverse events related to study procedures occurred in 3/41 MRIs performed, all related to sedation. These results suggest that hydroxyurea may have profound neuroprotective effect in children with SCD and support a definitive phase III study to encourage the early use of hydroxyurea in all infants with SCD.

Assessing bias in the causal role of HPV in oral cancer: Asystematic review and meta-analysis.

High-risk human papillomaviruses (HPV) are an established cause of oropharyngeal cancer. Their relationship with oral cancer remains unclear with detection ranging from 0% to 100%. HPV DNA detection or evidence of exposure alone is insufficient to conclude causality. This systematic review assesses the extent of bias in studies of HPV detection in cancers of the oral cavity. PubMed, Ovid MEDLINE, EMBASE, and PsycInfo databases were searched for observational studies reporting the effect of HPV in oral cavity specific cancers. All 15 included studies presented HPV DNA detection or serum HPV-antibodies, none included mRNA E6/E7 analysis. Cases with oral cancer had 5.36 times (95% CI 3.29-8.72) higher odds of having HPV detected compared to controls. The odds of HPV detection were higher in cell-based (OR 6.93; 95% CI 0.82-58.55) and tissue samples (OR 5.28; 95% CI 3.41-8.18) than blood-based samples (OR 3.36; 95% CI 1.53-7.40). When cancer site is clearly differentiated between oropharynx and oral cavity, 12 studies showed strong association between HPV and oral cancer, but the available estimates lack internal validity due to inconsistent measurements, high confounding, and lack of gold standard testing. There is not high-quality evidence to conclude a causal relationship of HPV with oral cancer.

Unintended Consequences of Digital Behavior Change Interventions

Abstract: Background: Digital Behavior Change Interventions (DBCIs) offer substantial potential to widely disseminate prevention and health promotion content. One key issue remains the absence of high-quality evidence of the effects of DBCIs for long-term health outcomes and unintended consequences. Here, we argue that in addition to better-quality evidence for effects on health, a more consideration of unintended consequences of DBCIs on multiple levels is warranted. Objectives: We suggest a multilevel perspective on unintended consequences of DBCIs building on a socio-ecological understanding of health promotion and prevention. Methods: Narrative literature review. Results: Unintended consequences of DBCIs can be located on the level of the individual engaging with DBCIs, on a level of social interactions, and on the level of health services, in multiple domains from health-related, behavior modification, affective aspects to data privacy and financial implications. Implications: Our proposed social–ecological perspective improves the classification of unintended consequences of DBCIs. This could facilitate building a cumulative evidence base to support the development of more effective and inclusive DBCIs.

The use of modafinil for the treatment of fatigue in multiple sclerosis: A systematic review and meta-analysis of controlled clinical trials.

Multiple sclerosis (MS) is a debilitating neurological condition affecting nearly one million people across the United States. Among the most prominent symptoms of the condition are excessive fatigue and daytime sleepiness. Numerous clinical trials have investigated the efficacy of modafinil in addressing fatigue among these patients. The objective of the present study is to assess the safety and efficacy of modafinil for the treatment of fatigue in MS. An electronic search of PUBMED, ScienceDirect, and Cochrane Central was conducted for articles published from inception to December 2023 using search terms such as "modafinil," "fatigue," and "MS." Seven studies were included in our analysis. Modafinil leads to a meaningful reduction in fatigue when compared with placebo, as measured by Modified Fatigue Impact Scale [mean difference (MD)=-4.42 [-8.01, -.84]; I2=45%; p=.02] and Epworth Sleepiness Scale [MD=-.87 [-1.64, -.10]; I2=0%; p=.03]. Modafinil also demonstrated a greater risk of precipitating adverse events (e.g., insomnia, gastrointestinal symptoms) when compared with placebo [RR=1.30 [1.03, 1.66]; I2=0%; p=.03]. In quality-of-life assessments, modafinil was associated with overall improvement in well-being [standardized mean difference=.18 [.01,.35]; I2=56%; p=.04]. The data indicates that modafinil confers a therapeutic benefit when treating fatigue in patients with MS and improves overall quality of life; however, there is a risk of precipitating adverse events. Ultimately, higher quality of evidence may be required to better inform clinical management.

Efficacy of scrambler therapy in chronic neuropathic pain: pairwise and dose-response meta-analysis

Chronic neuropathic pain (CNP) affects 7% of the world’s population and is challenging to control since existing medications are inadequate and have negative effects. Electrocutaneous devices, such as scrambler therapy (ST), have emerged as a possible option and have shown promising results in multiple randomized controlled trials (RCTs). However, the long-term efficacy of ST remains unknown. We aimed to evaluate the efficacy of ST in CNP reduction over time. We used the data sources including PubMed, Embase, Scopus, and Cochrane Central Register of Controlled Trials from inception to September 2023. Five placebo and three routine-care controlled RCTs were selected among the screened abstracts. Two authors independently extracted the data. Data was pooled using a model under the common parameters assumption. The studies were evaluated for methodological quality using the MethodologicAl STandard for Epidemiological Research (MASTER) scale. The primary outcome measure was pain reduction; pain was converted to a common 0 to 10 scale, and a weighted mean difference of more than 2 points on a 10-point pain scale was considered clinically important. Eight RCTs that evaluated the effect of ST on CNP were included, with a total sample size of 350 participants. None of the participants withdrew in all these trials owing to adverse events or lack of efficacy. There was high-quality evidence that ST reduced pain in the short term, with a mean difference of –3 points. The dose-response meta-analysis demonstrated a significant reduction in pain scores post-treatment, with a peak reduction at day 40. The effect of ST remained below the baseline values for 90 days, although with limited certainty. This study is the first dose-response meta-analysis to assess the duration of efficacy of ST in the treatment of CNP. The results demonstrated a clinically significant and more sustained reduction in pain created by ST compared to conventional treatments. Our findings indicate that ST could be used as a safe and effective alternative for managing CNP.

Guidelines and regulations applicable to vitro diagnostic tests in the UK: a scoping review

ObjectiveTo describe recommendations applicable to new diagnostic and screening tests brought to market in the UK as of 01 June 2023; and extract agreements, disagreements and gaps.DesignExtant regulations, recommendations and...

Risk factors for arrhythmias occurred in cancer patients after chemotherapy: An evidence-based systematic review and meta-analysis

ObjectivesThis study aimed to summarize the existing literature on risk factors for arrhythmias after chemotherapy in cancer patients. To provide reliable evidence for treating arrhythmias after chemotherapy in oncology patients by assessing multiple biasing factors in the literature and quantifying the risk factors. MethodsThe risk factors for arrhythmia following tumor chemotherapy were systematically collected from various reputable databases, including PubMed, Cochrane Library, MEDLINE, EMBASE, and multiple Chinese databases, covering the period from inception to May 2023. Two independent reviewers performed rigorous article screening, data extraction, and assessment of research quality. Data analysis was conducted using Review Manager 5.4 software, ensuring a standardized and robust approach to evaluate the gathered evidence. ResultsThe analysis of chemotherapy-induced arrhythmias included 16 articles, encompassing 14,785 cancer patients. Among the patients, 3295 belonged to the arrhythmia group, while 11,490 were in the non-arrhythmia group. These studies identified 12 significant risk factors associated with arrhythmias following chemotherapy in cancer patients. The findings of the analysis are as follows. General patient characteristicsThe incidence of post-chemotherapy arrhythmias was 14.33 times higher in oncology patients aged ≥60 years compared to patients <60 years of age [OR = 14.33, 95%CI (8.51, 24.13), P＜0.00001]. Patients with a smoking history exhibited a 1.67-fold higher risk of arrhythmia after chemotherapy [OR = 1.67, 95%CI (1.24, 2.25), P = 0.0007]. However, there was no significant correlation between gender and body mass index (BMI) with arrhythmia after chemotherapy in oncology patients (P = 0.52; P = 0.19) Disease-related factorsPatients with a history of hypertension, diabetes, and cardiovascular disease had a 1.93-fold, 1.30-fold, and 1.76-fold increased risk of arrhythmia after chemotherapy, respectively [OR = 1.93, 95%CI (1.66, 2.24), P＜0.00001; OR = 1.30, 95%CI (1.10, 2.52), P = 0.002; OR = 1.76, 95%CI (1.51, 2.05), P＜0.00001]. Additionally, the incidence of arrhythmia increased 1.97 times in patients with electrolyte and acid-base balance disorders following chemotherapy [OR = 1.97, 95%CI (1.41, 2.76), P＜0.00001] Chemotherapy-related factorsSeven articles examined the association between chemotherapy drugs and post-chemotherapy arrhythmias. The results indicated that oncology patients were 3.03 times more likely to develop arrhythmias with chemotherapy drugs compared to non-chemotherapy drugs [OR = 3.03, 95%CI (2.59, 3.54), P＜0.00001]. Notably, anthracyclines and fluorouracil chemotherapy demonstrated a 2.98-fold and 3.35-fold increased risk of arrhythmia after chemotherapy, respectively [OR = 2.98, 95%CI (2.51, 3.03), P＜0.00001; OR = 3.35, 95%CI (2.20, 5.10), P＜0.00001]. The risk of arrhythmia after chemotherapy was 1.72 times higher in patients with chemotherapy cycles longer than 4 weeks than those with cycles shorter than 4 weeks [OR = 1.72, 95%CI (1.30, 2.28), P = 0.0001] ConclusionThe occurrence of arrhythmia after chemotherapy in cancer patients was significantly associated with the patient's age, history of smoking, history of hypertension, history of diabetes, history of cardiovascular disease, chemotherapy drug use, and cycle. However, further high-quality evidence is needed to support these results.

Quantifying factors which influence the value of approved biologic treatments in SLE a Multi-Criteria Decision Analysis (MCDA) approach in Spain

Objective: The objective of the present study is to assess the value contribution of belimumab compared with anifrolumab in the treatment of adult patients with systemic lupus erythematosus (SLE) in Spain using reflective Multi-Criteria Decision Analysis (MCDA). Methodology: A literature review was conducted to complete the criteria included in the EVIDEM MCDA framework. A multidisciplinary panel of eight experts, including two rheumatologists and one internist specialized in managing patients with SLE, two regional decision-makers, and three hospital pharmacists scored each criterion of the MCDA framework used. The study was developed following the MCDA methodology, including criteria scoring, aggregate scoring, value determination, and discussion of findings. Performance scores provided by experts were analysed quantitatively and qualitatively. Results: SLE was considered a potentially severe and heterogeneous disease, with important unmet needs affecting a considerably sized population. Experts considered the absence of curative therapy, the adverse effects of conventional treatments, constitutive manifestations such as fatigue and organ damage accrual as relevant unmet needs in the management of SLE. Belimumab was perceived to have a slightly higher efficacy profile, with better safety profile and to provide improved Patient Reported Outcomes (PROs) than anifrolumab. Experts considered that belimumab and anifrolumab do not differ in terms of cost of intervention; however, belimumab’s advantage lies in its potential to generate savings by reducing both direct and indirect costs. Overall, belimumab’s therapeutic impact on patients with SLE is considered high and supported by high-quality evidence. Conclusion: Based on reflective MCDA methodology, belimumab is perceived as a value-added option for the treatment of adult patients with SLE when compared with anifrolumab. Nevertheless, it is important to consider the lack of head-to-head comparations and long-term data for anifrolumab regarding these conclusions. These findings underscore the potential benefits of belimumab for patients and the healthcare system, emphasizing its role as an add-on therapy in improving outcomes for individuals with SLE. Keywords: belimumab, systemic lupus erythematous, anifrolumab, autoimmune disease, multi-criteria decision analysis (MCDA).

Evaluation of the effect of low-intensity pulsed ultrasound in pain and dysfunction for knee osteoarthritis: a double-blind, randomised controlled trial protocol

IntroductionOsteoarthritis (OA) is the most common joint disorder among musculoskeletal conditions. Non-surgical treatment is the standard therapy for knee OA (KOA). Ultrasound therapy is recommended for alleviating pain and dysfunction...

Efficacy and safety of Qingfei Huatan formula in the treatment of acute exacerbation of chronic obstructive pulmonary disease: A multi-centre, randomised, double-blind, placebo-controlled trial

BackgroundChronic obstructive pulmonary disease (COPD), a common respiratory disease, can be effectively treated by traditional Chinese medicine (TCM). Qingfei Huatan, a TCM formula, has been reported to effectively alleviate the clinical symptoms of COPD patients. However, there is a lack of multi-centre, randomised, double-blind, controlled clinical trials documenting the clinical efficacy and safety of this formula in the treatment of acute exacerbation of COPD (AECOPD). ObjectiveThis study evaluated the efficacy and safety of Qingfei Huatan formula in the treatment of AECOPD, thereby providing high-quality clinical evidence. Design, setting, participants and interventionsA total of 276 patients with AECOPD were included in this multi-centre, randomised, double-blind, placebo-controlled trial and were randomised into treatment and control groups at a ratio of 1:1. Patients in the treatment and control groups took Qingfei Huatan granules or simulated Qingfei Huatan granules twice a day, for 14 days, in addition to Western medicine treatment. All patients were followed up for 3 months. Main outcome measuresThe primary outcome was time taken to symptom stabilisation. The secondary outcomes included duration of antibiotic use, clinical symptom and sign score, TCM syndrome score, dyspnoea score, and quality of life (QOL) score. Meanwhile, the safety of the formula was assessed through routine urine and stool tests, electrocardiograms, liver and kidney function tests, and the observation of adverse events throughout the trial. ResultsThe time taken for effective stabilisation (P < 0.05) and obvious stabilisation (P < 0.01), and the duration of antibiotic use (P < 0.05) were significantly shorter in the treatment group than in the control group. On days 6, 9, 12 and 14 of treatment, clinical symptom and sign score decreased in both groups, particularly in the treatment group (P < 0.01). On days 9, 12 and 14 of treatment, the TCM syndrome scores of both groups were reduced (P < 0.01), with more significant reductions in the treatment group. At 3 months after the end of treatment, the treatment group continued to have lower clinical symptom and sign score and TCM syndrome score than the control group (P < 0.01). On days 6, 9, 12 and 14 of treatment, dyspnoea and QOL scores were markedly reduced in the two groups (P < 0.05 and P < 0.01, respectively), especially in the treatment group. At 3 months after the end of treatment, dyspnoea and QOL scores were lower in the treatment group than those in the control group (P < 0.01). No serious adverse events were observed in either group. ConclusionThe Qingfei Huatan formula can effectively shorten the duration of AECOPD and antibiotic use, significantly relieve clinical symptoms, and increase QOL for AECOPD patients, with a favourable safety profile. These results suggest that this formula can be used as a complementary treatment for AECOPD patients.Trial registration: The protocol was registered at the Chinese Clinical Trial Registry (ChiCTR1900026576).Please cite this article as: Zhu HZ, Li CY, Liu LJ, Tong JB, Lan ZH, Tian SG, Li Q, Tong XL, Wu JF, Zhu ZG, Li SY, Li JS. Efficacy and safety of Qingfei Huatan formula in the treatment of acute exacerbation of chronic obstructive pulmonary disease: A multi-centre, randomised, double-blind, placebo-controlled trial. J Integr Med. 2024; 22(5): 561–569.

Gothenburg Breast reconstruction (GoBreast) II protocol: a Swedish partially randomised patient preference, superiority trial comparing autologous and implant-based breast reconstruction

IntroductionAlthough breast reconstruction is an integral part of breast cancer treatment, there is little high-quality evidence to indicate which method is the most effective. Randomised controlled trials (RCTs) are generally...

Racial and ethnic disparities in reproductive medicine in the United States: a narrative review of contemporary high-quality evidence

There has been increasing debate around how or if race and ethnicity should be used in medical research-including the conceptualization of race as a biological entity, a social construct, or a proxy for racism. The objectives of this narrative review are to identify and synthesize reported racial and ethnic inequalities in obstetrics and gynecology (ob/gyn) and develop informed recommendations for racial and ethnic inequity research in ob/gyn. A reproducible search of the eight highest impact ob/gyn journals was conducted. Articles published between January 1, 2010, and June 30, 2023 containing keywords related to racial and ethnic disparities, bias, prejudice, inequalities, and inequities were included (n=318). Data were abstracted and summarized into four themes: 1) access to care, 2) adherence to national guidelines, 3) clinical outcomes, and 4) clinical trial diversity. Research related to each theme was organized topically under the headings i) obstetrics, ii) reproductive medicine, iii) gynecologic cancer, and iv) other. Additionally, interactive tables were developed. These include data on study timeline, population, location, and results for every article. The tables enable readers to filter by journal, publication year, race and ethnicity, and topic. Numerous studies identified adverse reproductive outcomes among racial and ethnic minorities as compared to white patients, that persist despite adjusting for differential access to care, socioeconomic or lifestyle factors, and clinical characteristics. These include higher maternal morbidity and mortality among Black and Hispanic/Latinx patients; reduced success during fertility treatments for Black, Hispanic/Latinx, and Asian patients; and lower survival rates and lower likelihood of receiving guideline concordant care for gynecological cancers for non-white patients. We conclude that many racial and ethnic inequities in ob/gyn cannot be fully attributed to patient characteristics or access to care. Research focused on explaining these disparities based on biological differences incorrectly reinforces the notion of race as a biological trait. More research that deconstructs race and assesses efficacy of interventions to reduce these disparities is needed.

Pediatric Limb Ischemia: Our Experience from a Tertiary Hospital in Oman

Introduction: Pediatric acute limb ischemia (PALI) is a consequence of sudden loss of blood flow to an extremity that can progress to irreversible ischemia if not promptly treated. This may unfortunately result in life-changing consequences which include limb loss, limb length discrepancy, emotional trauma, and or financial stress. Due to the rarity of this condition, and the lack of high-quality evidence, treatment strategies have largely been anecdotal or extrapolated from treatment of the adult patient. The article is a guide to improve overall functional outcomes and reduce morbidity of PALI. Methods: The authors retrospectively analysed patient data on the electronic patient record of the hospital between January 2021 and December 2023. The patients with PALI were divided into three broad categories: iatrogenic arterial injury managed with the best medical management, managed surgically; iatrogenic deep vein injury/thrombosis, and trauma. Results: A total of 13 patients were referred during the study period. 9 were male. 8 cases were line related, 2 trauma and 3 acute deep vein thrombosis [DVT]. Two patients succumbed prior to intervention. Eight patients were managed with best medical therapy, two surgically and one by endovascular means. Conclusion: Since experience worldwide is limited with PALI, we decided to share our experience and a propose comprehensive algorithm for the management of PALI emphasizing a multi-disciplinary team approach that we follow at our hospital. Early and decisive involvement of vascular surgeons, hematologists, intervention radiologists, and pediatric intensive care physicians is necessary to achieve the most favorable outcomes.