Nonrandomized Interventional Study Research Articles

Single organ metastatic sites in non-small cell lung cancer: Patient characteristics, treatment patterns and outcomes from a large retrospective Canadian cohort

BackgroundThere is a paucity of information about the characteristics, treatment patterns, and outcomes of non-small cell lung cancer (NSCLC) patients with single organ metastasis (SOM). MethodsThis retrospective cohort study includes all patients with a diagnosis of stage IV NSCLC diagnosed from 2014 to 2016 and treated at Princess Margaret Cancer Centre. We compared baseline characteristics and patterns of metastatic sites between patients with SOM versus multiple (M)OM. Additionally, we identified treatment modalities and outcomes for patients with SOM. Cox multivariable models (MVA) were utilized to evaluate differences in overall survival (OS) between the SOM and MOM cohorts. ResultsOf 893 pts analyzed, 457 (51 %) had SOM, while 436 (49 %) had MOM at initial diagnosis. Demographics were comparable between the two groups. Brain was the most common site of metastasis for SOM patients. When compared to the MOM group, the SOM group had lower percentages of liver and adrenal metastases. Amongst SOM patients, 54 % received single modality treatment, and 20 % did not receive any treatment for their SOM. In MVA, patients with liver (HR 2.4), bone (HR 1.8), and pleural (HR 1.7) metastasis as their SOM site had the worst outcomes, with median OS of 6.8 months, 12.1 months, and 13.0 months respectively. Patients with SOM had a significantly improved median OS compared to those with MOM (15.9 months vs. 10.6 months; HR 0.56, 95 % CI 0.47–0.66, p < 0.001). ConclusionIn NSCLC patients who presented with SOM, survival correlated with the initial organ involved and was better overall compared to patients with MOM. SOM NSCLC may benefit from specific management strategies and SOM patients could be considered as a specific subgroup for survival analyses in observational and non-randomized interventional studies. In clinical trials, SOM can be considered as a stratification factor in the future.

Aromatherapy for the prevention of postoperative nausea and vomiting: A systematic review and meta-analysis

ABSTRACT Objectives: Postoperative nausea and vomiting (PONV) are common complications following surgical procedures. While drug-based treatments are standard, there is increasing interest in nonpharmacological alternatives, such as aromatherapy, due to potential benefits and minimal side effects. This study aimed to assess the effectiveness of aromatherapy in preventing PONV. Materials and Methods: A comprehensive systematic review and meta-analysis were conducted using PubMed, Cochrane Library, EMBASE, and CINAHL databases for studies published up to May 2023. The included studies were randomized controlled trials (RCTs) and nonrandomized studies of interventions that examined the impact of aromatherapy on PONV. The risk of bias was assessed, and the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach was employed to evaluate the certainty of the evidence. Results: Eleven studies were selected for review, with eight RCTs included in the meta-analysis. Aromatherapy effectively reduced postoperative nausea severity (standardized mean difference [SMD]: −0.93, 95% confidence interval [CI]: −1.64 to −0.22; P = 0.010), but the reduction in vomiting episodes was not statistically significant (SMD: −0.81, 95% CI: −1.98-0.37; P = 0.180). Subgroup analysis indicated that ginger essence, lavender, and peppermint oils were particularly effective in managing postoperative nausea. However, due to significant statistical heterogeneity and potential biases in the studies, the results should be interpreted with caution. The certainty of the evidence, as evaluated by the GRADE approach, was low. Conclusion: Preliminary evidence supports the potential benefit of aromatherapy in reducing the severity of postoperative nausea. However, given the low certainty of current evidence, more rigorous and standardized research is needed. The safety, affordability, and potential benefits to patient comfort make aromatherapy a promising area for further research in postoperative care.

Comparison of Facial Aesthetic Evaluation Given by Patients with Cleft Lip and/or Palate and Professionals: A Systematic Review.

To compare the differences of facial aesthetic evaluation between patients with Cleft Lip and/or Palate (CL/P) and professionals for the treatment outcome of CL/P. This systematic review was conducted on MedLine, Web of Science, Embase and Cochrane Library databases. The Risk of Bias in Non-randomized Studies of Intervention (ROBINS-I) tool was used to evaluate the included researches. Not applicable. Patients with CL/P and professionals. Not applicable. The facial aesthetic evaluation of patients with CL/P and professionals. Among the 1695 literatures retrieved, 22 articles were included, including 974 patients with CL/P and 251 professionals. The bias risk assessment on 21 articles was rated "Moderate" and only one article was rated "Serious". Due to the high heterogeneity of the included studies, meta-analysis was not possible, so descriptive analysis was conducted. Among the included studies, two articles indicated similar views from both groups, 19 noted differences between the two groups, of which three articles indicated more positive evaluation by professionals and nine articles indicated more positive evaluation by patients. The available data indicate that there is a difference between patients with CL/P and professionals in the aesthetic evaluation, but it is not clear which group is more positive. During the treatment of patients with CL/P, apart from the objective aesthetic evaluation, professionals should fully consider subjective ideas and self-assessment of patients, in order to improve the quality of life for patients.

Percutaneous Coronary Intervention versus Optimal Medical Therapy in Patients with Chronic Total Occlusion: A Meta-Analysis

Background/Objectives: Chronic total occlusion (CTO) is a prevalent finding in patients with coronary artery disease and is associated with increased mortality. Prior reports on the efficacy of percutaneous coronary intervention (PCI) compared to optimal medical therapy (OMT) were controversial. Following the emergence of recently published new evidence, a meta-analysis is warranted. The current meta-analysis assessed the effects of PCI compared to OMT in the treatment of CTO. Methods: A structured literature search was performed. Randomized controlled trials (RCTs) and non-randomized controlled studies of interventions were eligible. The primary outcome was an accumulated composite of cardiac mortality, myocardial infarction and target vessel/lesion revascularization events. Results: Thirty-two studies reporting on 11260 patients were included. Of these, 5712 (50.7%) were assigned to the PCI and 5548 (49.3%) were allocated to the OMT group. The primary outcome occurred in 14.6% of the PCI and 20.1% of the OMT group (12 trials, OR 0.66, 95% CI 0.50 to 0.88, p = 0.005, I2 = 67%). Subgrouping demonstrated a consistent reduction in the primary outcome for the PCI group in RCTs (six trials, OR 0.58, 95% CI 0.33 to 0.99, p = 0.05). The primary outcome reduction was irrespective of the study design, and it was replicable in sensitivity and subgroup analyses. Advantages in other outcomes were rather related to statistical pooling effects and dominated by observational data. Conclusions: CTO-PCI was associated with improved patient-oriented primary outcome compared to OMT in a study-level meta-analysis. This composite outcome effect was mainly driven by target vessel treatment, but a significant reduction in mortality and myocardial infarction was observed, irrespectively. These findings have hypothesis-generating implications. Future RCTs with adequate statistical power are eagerly awaited.

The prevention of adverse pregnancy outcomes by periodontal treatment during pregnancy (PROBE) intervention study-A controlled intervention study: Protocol paper.

Pregnancy increases the risk of periodontitis due to the increase in progesterone and estrogen. Moreover, periodontitis during pregnancy is associated with development of pregnancy and birth related complications. The aim of this study is to determine, whether periodontal treatment during pregnancy can reduce systemic inflammation and lower the risk of adverse pregnancy and birth related outcomes. The PROBE study is a non-randomized controlled intervention study conducted among 600 pregnant women with periodontitis. The women will be recruited among all pregnant women at two Danish hospitals in Region Zealand during their nuchal translucency scan and will subsequently be screened for periodontitis. The intervention group includes 300 pregnant women, who will be offered state-of-the-art periodontal treatment during pregnancy. The control group includes additional 300 pregnant women, who will be offered periodontal treatment after giving birth. Outcome measures include periodontal measures, inflammatory, hormonal and glycaemic markers as well as the prevalence of preterm birth risk, low birth weight and risk markers of gestational diabetes mellitus (GDM) and preeclampsia that will be collected from all screened women and further during pregnancy week 20 and pregnancy week 35 for women enrolled in the intervention. The study's findings will be published in peer reviewed journals and disseminated at national and international conferences and through social media. The PROBE study is designed to provide important new knowledge as to whether periodontal treatment during pregnancy can reduce the prevalence of complications related to pregnancy and birth. The study was registered on clinicaltrials.gov (NCT06110143).

Comparison of surgical outcomes between Kahook Dual Blade goniotomy and Trabectome surgery in patients with open-angle glaucoma

Objective: To compare the medium-term therapeutic effects of Kahook Dual Blade (KDB) goniotomy and Trabectome surgery in the treatment of patients with primary open-angle glaucoma (POAG). Methods: This study was a non-randomized prospective interventional controlled clinical study. POAG patients who underwent KDB goniotomy or Trabectome surgery at Beijing Tongren Hospital from May 2017 to April 2022 were enrolled. The definition of successful surgery was postoperative average intraocular pressure (IOP)≤21 mmHg (1 mmHg=0.133 kPa) and IOP decrease≥20%. Follow-up visits were conducted on the 1st day, 1st week, 1st, 3rd and 6th month after surgery. The IOP value, the number of IOP-lowering medications, the proportion of surgical success (average IOP≤21 mmHg at 6 months), and complications were evaluated. Statistical methods included independent sample t-test, Mann-Whitney rank sum test, χ2 test, repeated measures two-factor analysis of variance, Bonferroni, Friedman M test, Wilcoxon, and Log-rank. The Kaplan-Meier method was used to calculate the cumulative success rate of each group. Results: Seventeen male patients (17 eyes) and 10 female patients (10 eyes) were included. The mean age was (39.9±17.7) years old. There were 11 patients in the KDB group and 16 patients in the Trabectome group. There was no significant difference in clinical baseline conditions between the two groups (P>0.05). The IOPs in the KDB and Trabectome groups at postoperative 1 week [(16.6±6.3) and (16.4±4.1) mmHg) and 6 months [(17.8±5.3) and (19.9±4.4) mmHg) were lower than those before surgery [(25.1±9.3) and (27.4±9.1) mmHg) (all P<0.05). There was no significant difference in the overall IOP between groups (P>0.05). The IOP reduction rates in the KDB and Trabectome groups were 23.4% and 19.0%, with no significant difference (P=0.674). The numbers of IOP-lowering medications used in the KDB and Trabectome groups at 3 months [2.0 (1.0, 4.0) and 2.0 (1.0, 2.3)] and 6 months [2.0 (0.0, 4.0) and 2.0 (1.0, 3.0)] after surgery were not significantly different from those before surgery [4.0 (2.0, 4.0) and 3.0 (2.0, 4.0)] (both P>0.05). There was no statistical significance in the overall number of IOP-lowering medications used between the two groups (P>0.05). There was also no statistically significant difference in the proportion of patients with an IOP decrease of≥20% and the proportion of patients whose mean postoperative IOP was≤21 mmHg (all P>0.05). The proportions of IOP≤21 mmHg in the KDB group and the Trabectome group at 6 months after surgery were 81.8% and 68.8% (P>0.05). Serious intraoperative or postoperative complications occurred in neither group. Conclusions: Both KDB trabeculotomy and Trabectome surgery can effectively reduce IOP and have a good safety profile in treating POAG, with the same number of IOP-lowering medications.

Clinical effectiveness of drop-in mental health services at paediatric hospitals: A non-randomised multi-site study for children and young people and their families - study protocol.

Despite the high prevalence of mental health difficulties in children and young people with long-term health conditions (LTCs), these difficulties and experiences are often overlooked and untreated. Previous research demonstrated the effectiveness of psychological support provided via a drop-in mental health centre located in a paediatric hospital. The aim of this prospective non-randomised single-arm multi-centre interventional study is to determine the clinical effectiveness of drop-in mental health services when implemented at paediatric hospitals in England. It is hypothesised that families who receive psychological interventions through the drop-in services will show improved emotional and behavioural symptoms. Outcomes will be measured at baseline and at 6-month follow-up. The primary outcome is the difference in the total difficulties score on the Strengths and Difficulties Questionnaire (SDQ) reported by parent or child at 6 months. Secondary outcomes include self and parent reported Paediatric Quality of Life Inventory (PedsQL), self-reported depression (PHQ-9) and anxiety measures (GAD-7) and family satisfaction (CSQ-8). This trial aims to determine the clinical effectiveness of providing psychological support in the context of LTCs through drop-in mental health services at paediatric hospitals in England. These findings will contribute to policies and practice addressing mental health needs in children and young people with other long-term health conditions. ISRCTN15063954, Registered on 9 December 2022.

Efficacy of Albendazole and Mebendazole Against Soil Transmitted Infections among Pre-School and School Age Children: A Systematic Review and Meta-Analysis.

Soil-transmitted helminthic (STH) infections are the leading cause of stunting among children. To lessen the burden, the World Health Organization (WHO) recommended a periodic deworming program through the use of single-dose therapy in the endemic regions. Therefore, the purpose of this study was to synthesize evidence about the efficacy of anthelminthic drugs against STH infections among preschool and school-age children. The Preferred Reposting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria were followed in this study. Relevant electronic databases, including PubMed, Scopus, Embase, DOAJ, Science Direct, the WHO Clinical Trials.gov library, Google Scholar, and AJOL databases, were searched for relevant publications. Randomized controlled trials (RCTs) and non-randomized interventional studies focused on the efficacy of albendazole and mebendazole against STHs in children were included in the study. Review Manager was used to analyze the data. A random effects model was used to obtain the pooled estimated efficacy. To evaluate heterogeneity, the I2 test and Cochrane Q (χ2) were employed. The risk of publication bias was investigated using Egger's test and the funnel plot. The protocol of this review was registered at the PROSPERO international prospective register of systematic reviews (CRD42023401196). Of the 69 publications selected for the systematic review, 66 with complete data were included in the meta-analysis. Single doses of albendazole and mebendazole have shown satisfactory efficacy [egg reduction rate (ERR)] against Ascaris lumbricoides [95.54% (95% CI: 88.75-102.34%) and 98.69% (95% CI: 97.68-99.65%), respectively. The effectiveness of these two drugs against Trichuris trichiura and hookworms was comparatively low (< 80% ERR), except for albendazole, which showed high ERRs [93.44% (95%CI: 92.39-94.49%)] against hookworms. The cure rate (CR) of albendazole against T. trichiura, A. lumbricoides, and hookworms were 50.8%, 91.3%, and 78.32%, respectively. Likewise, mebendazole showed CRs of 48.15%, 92.8%, and 49.32% against T. trichiura, A. lumbricoides, and hookworms, respectively. Subgroups such as studies conducted after 2000, diagnostic type (McMaster), and longer follow-up weeks significantly reduced the efficacy of the two drugs against T. trichura. While the combination of albendazole or mebendazole with other drugs and RCT showed significantly improved efficacy against T. trichura. The count of eggs per gram of stool (EPG) was identified as one of the variables that negatively and significantly influenced the efficacy of albendazole or mebendazole against A. lumbricoides. Despite the wide range of ERRs and CR reported in the different articles included in this review, the pooled estimated efficacy of albendazole and mebendazole against STHs falls in the satisfactory category of WHO recommendations. Further evaluation of the combination of anthelminthic drugs as a preventive chemotherapy option and routine drug efficacy testing are necessary to prevent the emergence and widespread use of drug-resistant STHs.

How does communication affect patient safety? Protocol for a systematic review and logic model

IntroductionOne in 10 patients are harmed in healthcare, more than three million deaths occur annually worldwide due to patient safety incidents, and the economic burden of patient safety incidents accounts...

Epidemiological Burden of Neurotrauma in Nigeria: A Systematic Review and Pooled Analysis of 45,763 Patients

Neurotrauma is a significant cause of morbidity and mortality in Nigeria. We conducted this systematic review to generate nationally generalizable reference data for the country. Four research databases and gray literature sources were electronically searched. Risk of bias was assessed using the Risk of Bias in Non-Randomized Studies of Interventions and Cochrane's risk of bias tools. Descriptive analysis, narrative synthesis, and statistical analysis (via paired t-tests and χ2 independence tests) were performed on relevant article metrics (α=0.05). We identified a cohort of 45,763 patients from 254 articles. The overall risk of bias was moderate to high. Most articles employed retrospective cohort study designs (37.4%) and were published during the last 2decades (81.89%). The cohort's average age was 32.5years (standard deviation, 20.2) with a gender split of ∼3 males per female. Almost 90% of subjects were diagnosed with traumatic brain injury, with road traffic accidents (68.6%) being the greatest cause. Altered consciousness (48.4%) was the most commonly reported clinical feature. Computed tomography (53.5%) was the most commonly used imaging modality, with skull (25.7%) and vertebral fracture (14.1%) being the most common radiological findings for traumatic brain injury and traumatic spinal injury, respectively. Two-thirds of patients were treated nonoperatively. Outcomes were favorable in 63.7% of traumatic brain injury patients, but in only 20.9% of traumatic spinal injury patients. Pressure sores, infection, and motor deficits were the most commonly reported complications in the latter. This systematic review and pooled analysis demonstrate the significant burden of neurotrauma across Nigeria.

Comparison between Woven EndoBridge and coiling with and without stent assistance for intracranial bifurcation and wide-neck aneurysms: a comprehensive systematic review and meta-analysis.

The recent introduction of the Woven EndoBridge (WEB) has presented an alternative treatment modality for intracranial bifurcation and wide-neck aneurysms with a growing body of literature evaluating its efficacy. However, no previous systematic review has focused on comparing WEB with previously using endovascular approaches, specifically primary coiling (PC) and stent-assisted coiling (SAC). Herein, the authors present the first systematic review summarizing available literature to reach a consensus regarding the safety and effectiveness of WEB. A systematic review of articles identified through a search of PubMed, Embase, Scopus, and Web of Science was conducted. Studies were included if they compared WEB with PC or SAC from any aspect for intracranial aneurysms. Risk of bias was assessed using the Risk of Bias in Non-Randomized Studies-of Interventions tool. Meta-analyses of the outcomes based on stent use and rupture status were performed. A total of 16 studies were included. The three endovascular approaches were comparable in terms of baseline characteristics except for older age and smaller aneurysm neck in the PC group (p < 0.05). Moreover, the follow-up duration was shorter in the WEB group (p < 0.05). Although the WEB group demonstrated lower complete and adequate immediate occlusion rates (p < 0.01), the rates at follow-up evaluations were comparable with SAC and PC (p = 0.61 and p = 0.27, respectively). The WEB group experienced significantly fewer unfavorable neurological outcomes than the SAC group (p = 0.04), while comparable to the PC group (p = 0.36). Retreatment rates were comparable between WEB and coiling (p = 0.92). The WEB group had fewer hemorrhagic and thromboembolic complications (p < 0.01 and p = 0.01, respectively), with similar neurological and procedure-related complications compared with combined PC and SAC groups. Lastly, mortality was comparable among the different endovascular approaches. This study provides evidence on the noninferiority of WEB compared with PC and SAC in terms of angiographic outcomes. Meanwhile, our findings on lower complication rates, cost, and improved operative aspects associated with WEB establish this novel endovascular treatment as a safe and effective alternative for the treatment of bifurcation and wide-neck aneurysms.

Root resorption in clear aligner treatment detected by CBCT: a Systematic review and Meta-analysis

ObjectiveThe aim of this study was to evaluate the amount of external apical root resorption in patients who had undergone orthodontic treatment with clear aligners evaluated using cone beam computed tomography. MethodsStudies that evaluated external apical root resorption before and after comprehensive orthodontic treatment with clear aligners were assessed by performing an electronic search from 5 databases comprising PubMed, SCOPUS, EBSCO, Cochrane Library, and LILACS and manual searches in the relevant journals and the reference lists of the included studies. Database search, elimination of duplicate studies, and data extraction were performed independently by 2 authors. The quality of the included studies was assessed using the Risk of Bias in Non-randomised Studies-of Interventions and the Cochrane Collaboration's Risk of Bias Tool. Studies that reported the tooth length or volume were used for quantitative analyses. ResultsNine studies were included in the meta-analysis. The overall root length after clear aligner treatment was significantly decreased compared with the pre-treatment length using cone beam computed tomography (mean differences = −0.56 mm, 95% confidence interval [−0.73, −0.38], P < .00001). However, only the maxillary central incisors, maxillary lateral incisors, and mandibular central incisors had significant reduction in root length. The meta-analysis from 3 studies also indicated that the root volume of the upper incisors also significantly decreased (mean differences = −13.34 mm3, 95% confidence interval [−16.57, −10.10], P < .00001). ConclusionsCurrent evidence suggests that clear aligners can cause minimal root resorption. The highest amount of root resorption was observed in the maxillary central incisors.

Rituximab versus tacrolimus as corticosteroid-sparing therapy for children with steroid-dependent nephrotic syndrome: A systematic review and meta-analysis of randomized and nonrandomized controlled trials

ABSTRACT Objectives: Prolonged use of corticosteroids induced complicated course in children with steroid-dependent nephrotic syndrome (SDNS), and the use of tacrolimus, a first-line alternative calcineurin inhibitor (CNI) agent was related to some unwanted adverse effects. Rituximab, a second alternative treatment has been proven to reliably reduce the number of relapses within 12 months with minimal adverse effects. Materials and Methods: Our review follows Preferred Reporting Items for Systematic Review and Meta-analysis guidelines. All the databases were derived from MEDLINE, Proquest, EBSCOhost, Wiley, and Google Scholar within the past 11 years. The risk of bias was evaluated using the Revised Cochrane Risk of Bias Tool for Randomized Trials (RoB 2) and Risk of Bias in Non-Randomized Studies of Interventions. Meta-analysis used Review Manager (version 5.4) with a random effect model to obtain a pooled mean difference (MD) and odds ratio with 95% confidence intervals (CIs). Results: Four studies were included based on our eligibility criteria, and only three were included in the quantitative analysis. Three studies had low and one study had a moderate risk of bias. Pooled data results indicated that Rituximab was superior to tacrolimus in reducing the number of patients with 1–2 relapses (MD = 0.44, [95% CI: 0.21–0.91]) and had higher eGFR values (MD = 6.67; [CI − 2.92–10.61]). However, Rituximab showed insignificant superiority compared to tacrolimus in reducing the number of patients with 3 relapses, sustained remission, cumulative steroid use, serum cholesterol, and serum albumin concentrations. Conclusion: Rituximab exhibits more advantages in treating SDNS compared to tacrolimus, although the treatment options are highly individualized. Both regimens must also be weighed against their potential side effects to achieve a better overall health status.

P082 Nephrolithiasis associated with uricosuric therapies for the treatment of gout: a systematic review

Abstract Background/Aims Uric acid nephrolithiasis is a recognised side-effect of uricosuric therapies and a contraindication to their use. The objective of this systematic review was to assess the incidence and risk of nephrolithiasis in people with gout receiving uricosuric therapy. Methods A systematic review was undertaken using MEDLINE, Embase, Cochrane Library, Web of Science and Clinical Trials electronic databases from inception to 16th May 2023. Pre-specified search terms relating to ‘gout’, ‘uricosuric drugs’ and ‘nephrolithiasis’ and their synonyms were used. Title/abstract and full-text screening and data extraction were undertaken independently by two reviewers. Randomised controlled trials (RCTs) and observational cohort studies assessing the incidence and risk of nephrolithiasis in adults with gout treated with uricosuric therapies were included (with or without a non-uricosuric urate-lowering therapy (ULT) comparator group). The Cochrane Risk of Bias (RoB)-2 for randomised trials and the Risk Of Bias In Non-randomised Studies of Interventions (ROBINS-I) tools were used to assess the quality of included RCTs and cohort studies respectively. Results 507 articles were identified, of which 22 studies (8 RCTs, 14 cohort studies) were eligible for inclusion. The mean age of participants ranged from 51.2 years (standard deviation (SD) 10.9) to 66.8 years (SD 9.1). Participants were predominantly male (range 69-100%). Length of follow-up ranged from three months to 10 years. Eleven studies included participants with a prior history of nephrolithiasis. Ten studies assessed Benzbromarone monotherapy, five Lesinurad plus xanthine oxidase inhibitor (XOI), four Probenecid, three Sulfinpyrazone and one Lesinurad monotherapy (total 3091 participants). Ten studies included a non-uricosuric comparator group(s) (five placebo plus XOI, four XOI only, and one placebo only (total 1386 participants)), whereas 12 had no comparator group. Most studies assessed nephrolithiasis through clinical adverse event reporting rather than systematic assessment. The incidence of nephrolithiasis ranged from 0.0% to 11.8% in people receiving uricosuric therapy (four studies reported no stone events; incidence 0.1%-5% in seven studies, 5.1-10% in 9, and &amp;gt;10% in two). The incidence of nephrolithiasis ranged from 0.0% to 4.2% in those not receiving uricosurics. No studies calculated the risk of nephrolithiasis between uricosuric-treated and untreated groups. Few studies documented renal stone composition or reported the severity of clinical presentation of nephrolithiasis events. Conclusion Nephrolithiasis is a common side-effect of uricosuric therapy for gout. Future studies should provide risk estimates between uricosuric-treated and untreated groups, describe clinical presentation of stone events and, where possible, assess stone composition. Disclosure C. Dahanayake: None. R. Bajpai: Other; Dr Bajpai is a member of the Versus Arthritis College of Experts. K.M. Jordan: Other; Dr Jordan is a Trustee of the UK Gout Society. M. Lambie: Honoraria; Dr Lambie has received speakers honoraria from Baxter Healthcare and Fresenius Medical Care. Grants/research support; Dr Lambie has received an unrestricted research grant from Baxter Healthcare. E. Roddy: None.

Implementation of an antimicrobial stewardship program for urinary tract infections in long-term care facilities: a cluster-controlled intervention study

BackgroundWidespread inappropriate use of antimicrobial substances drives resistance development worldwide. In long-term care facilities (LTCF), antibiotics are among the most frequently prescribed medications. More than one third of antimicrobial agents prescribed in LTCFs are for urinary tract infections (UTI). We aimed to increase the number of appropriate antimicrobial treatments for UTIs in LTCFs using a multi-faceted antimicrobial stewardship intervention.MethodsWe performed a non-randomized cluster-controlled intervention study. Four LTCFs of the Geriatric Health Centers Graz were the intervention group, four LTCFs served as control group. The main components of the intervention were: voluntary continuing medical education for primary care physicians, distribution of a written guideline, implementation of the project homepage to distribute guidelines and videos and onsite training for nursing staff. Local nursing staff recorded data on UTI episodes in an online case report platform. Two blinded reviewers assessed whether treatments were adequate.Results326 UTI episodes were recorded, 161 in the intervention group and 165 in the control group. During the intervention period, risk ratio for inadequate indication for treatment was 0.41 (95% CI 0.19–0.90), p = 0.025. In theintervention group, the proportion of adequate antibiotic choices increased from 42.1% in the pre-intervention period, to 45.9% during the intervention and to 51% in the post-intervention period (absolute increase of 8.9%). In the control group, the proportion was 36.4%, 33.3% and 33.3%, respectively. The numerical difference between intervention group and control group in the post-intervention period was 17.7% (difference did not reach statistical significance). There were no significant differences between the control group and intervention group in the safety outcomes (proportion of clinical failure, number of hospital admissions due to UTI and adverse events due to antimicrobial treatment).ConclusionsAn antimicrobial stewardship program consisting of practice guidelines, local and web-based education for nursing staff and general practitioners resulted in a significant increase in adequate treatments (in terms of decision to treat the UTI) during the intervention period. However, this difference was not maintained in the post-intervention phase. Continued efforts to improve the quality of prescriptions further are necessary.Trial registrationThe trial was registered at ClinicalTrials.gov NCT04798365.

Potential Risks and Benefits of Desiccated Thyroid Extract for the Treatment of Hypothyroidism: A Systematic Review.

Background: Desiccated thyroid extract (DTE) is no longer recommended for the treatment of hypothyroidism but is still in use. This review aimed to summarize the available literature on treatment with DTE in adult patients with hypothyroidism. Methods: The search was conducted up until January 6, 2024, in six electronic databases. Two reviewers independently screened all the search results. The retrieved studies compared DTE treatment with levothyroxine or combination therapy with liothyronine and levothyroxine. The primary outcome was quality of life (QoL), and the secondary outcomes included symptoms, treatment preference, adverse effects, thyroid hormone levels, thyroid autoantibodies, cardiovascular measures, and gene polymorphisms in deiodinase enzymes. Results: In the qualitative synthesis, we included nine nonrandomized studies of interventions (NRSIs), two randomized clinical trials (RCTs), and three case reports. The overall quality of evidence was moderate to very low for the various outcomes. The RCTs found no difference between treatments regarding QoL and symptom score assessments. In the NRSIs, symptom and QoL assessments were in favor of DTE. The included studies indicated that DTE may cause an increase in heart rate, lower body weight, and lower high-density lipoprotein compared with other treatment regimens, but results were conflicting. Conclusions: Most studies of DTE treatment are hampered by an inferior design, and data on long-term effects and side effects are lacking. Two RCTs could not demonstrate any difference in QoL or symptom scores when comparing DTE with other thyroid hormone substitutions. Future trials of DTE in patients with hypothyroidism should be based on adequate study designs, validated measures of QoL, patients with reduced QoL, and the assessment of biomarkers reflecting long-term adverse effects.

Home versus in-centre haemodialysis for people with kidney failure.

Home versus in-centre haemodialysis for people with kidney failure.

Influence of sensory retraining on cortical reorganization in peripheral neuropathy: A systematic review.

This study systematically reviewed the literature about sensory retraining effect in comparison to other rehabilitative techniques on cortical reorganization in patients with peripheral neuropathic pain. TYPE: Systematic review. After performing an electronic search of PubMed, Web of Science, and Embase, risk of bias was assessed using the revised Cochrane risk of bias tool for randomized controlled trials and the risk of bias in non-randomized studies-of interventions for non-randomized studies of intervention. The strength of conclusion was determined using the evidence-based guideline development approach. Limited evidence indicates a higher increase in cortical inhibition and a higher reduction in cortical activation during a motor task of the affected hemisphere after graded motor imagery compared to wait-list. Higher reductions in map volume (total excitability of the cortical representation) of the affected hemisphere after peripheral electrical stimulation (PES) were observed when compared to transcranial direct current stimulation (tDCS) or to sham treatment with limited evidence. No other differences in cortical excitability and representation of the affected and non-affected hemisphere were observed when comparing mirror therapy with sham therapy or tDCS, PES with sham therapy or tDCS, and graded motor imagery with wait-list. Graded motor imagery and PES result in higher cortical excitability reductions of the affected hemisphere compared to wait-list, tDCS and sham treatment, respectively.

Effectiveness of autologous growth factor concentrates combined with topical minoxidil in patients of androgenic alopecia

Abstract Background: Concentrated growth factor (CGF) is a form of platelet concentrate. CGF contains abundant autologous growth factors that can promote cell proliferation, migration, osteogenic differentiation, and angiogenic properties in wound healing and bone regeneration. Recent studies revealed that CGF injection in hairless scalp could enhance hair density and optimize hair growth in androgenic alopecia (AGA) patients. Objective: The objective of this study was to study the effectiveness of autologous growth factor concentrate (GFC) combined with topical minoxidil in patients of AGA. Materials and Methods: A prospective nonrandomized interventional study with before and after comparison was carried out among 22 patients diagnosed with AGA. They were treated with deep intradermal injections of GFC in scalp. Four injections were administered 4 weeks apart, and patients were followed for 16 weeks. Treatment outcomes were assessed by taking photographs, using Global Aesthetic Improvement Scale (GAIS), and by performing a hair pull test after 16 weeks of therapy and compared to baseline. Incidence of adverse events was recorded. Patient’s self-satisfaction was assessed using a survey-based questionnaire at the end of the study. Results: Global macroscopic photographs showed a significant improvement in hair growth post-GFC therapy in all 22 patients. GAIS suggested that GFC treatments were effective in treating AGA, and the majority of patients were satisfied with their improvement. Hair pull test was negative in 100% of patients 4 months posttherapy. Therapy was found to be well tolerated with high patient satisfaction (100%). In addition, treatments resulted in a faster rate of hair growth and a decrease in greasy and unpleasant sensation of hair. Conclusion: GFC was found to have a promising role in the management of AGA in both males and females.

Revisión sistemática y metanálisis de estudios aleatorizados y no aleatorizados sobre revascularización guiada por reserva fraccional de flujo

Introduction and objectivesSeveral studies have investigated the effectiveness of fractional flow reserve (FFR) guidance in improving clinical outcomes after myocardial revascularization, yielding conflicting results. The aim of this study was to compare clinical outcomes in patients with coronary artery disease following FFR-guided or angiography-guided revascularization. MethodsBoth randomized controlled trials (RCTs) and nonrandomized intervention studies were included. Coprimary endpoints were all-cause death, myocardial infarction, and major adverse cardiovascular events (MACE). The study is registered with PROSPERO (CRD42022344765). ResultsA total of 30 studies enrolling 393 588 patients were included. FFR-guided revascularization was associated with significantly lower rates of all-cause death (OR, 0.63; 95%CI, 0.53-0.73), myocardial infarction (OR, 0.70; 95%CI, 0.59-0.84), and MACE (OR, 0.77; 95%CI, 0.70-0.85). When only RCTs were considered, no significant difference between the 2 strategies was observed for any endpoints. However, the use of FFR was associated with reduced rates of revascularizations and treated lesions. Metaregression suggested that the higher the rate of revascularized patients the lower the benefit of FFR guidance on MACE reduction compared with angiography guidance (P=.012). Similarly, higher rates of patients with acute coronary syndromes were associated with a lower benefit of FFR-guided revascularization (P=.039). ConclusionsFFR-guided revascularization was associated with lower rates of all-cause death, myocardial infarction and MACE compared with angiographic guidance, with RCTs and nonrandomized intervention studies yielding conflicting data. The benefits of FFR-guidance seem to be less evident in studies with high revascularization rates and with a high prevalence of patients with acute coronary syndrome.