Reviews on recent clinical trials最新文献

{"title":"Clinical and Morphological Evaluation of Erosive and Ulcerative Gastric Lesions in Patients with Rheumatoid Arthritis.","authors":"Vladimir A Beloglazov,&nbsp;Andrey V Petrov,&nbsp;Vitalii B Kaliberdenko,&nbsp;Kseniya V Abramova,&nbsp;Shanmugaraj Kulanthaivel","doi":"10.2174/1574887117666220513102512","DOIUrl":"https://doi.org/10.2174/1574887117666220513102512","url":null,"abstract":"<p><strong>Background: </strong>One of the most important problems associated with the treatment of Rheumatoid Arthritis (RA) is erosive-ulcerative lesions (EUL) of the gastroduodenal zone, which is associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs).</p><p><strong>Aims: </strong>Our research aims to study the clinical and histo-morphological criteria for forming the EUL of the gastroduodenal zone in patients with RA.</p><p><strong>Methods: </strong>Patients were divided into 3 groups, depending on the presence of an EUL, according to Fibrogastroduodenoscopy (FGDS) data with a negative test for H. pylori. Group 1 included RA patients without EUL (n = 18), group 2 RA patients with erosive lesions of the gastroduodenal zone (n = 57), and group 3 consisted of RA patients with ulcerative lesions (n = 17). As a norm, we used data from a survey of 18 healthy donors corresponding to RA patient's age and sex distribution, where no somatic pathology was revealed. GSRS questionnaire was used for assessment of subjective symptoms. For histomorphological studies, biopsy specimens were taken during FGDS using an Olympus Evis Exera II digital video endoscope.</p><p><strong>Results: </strong>Patients of RA with EUL in the gastro-duodenal zone were significantly different from the group of healthy donors and patients of group 1 by the severity of 5 symptoms related to the upper gastrointestinal tract according to the GSRS questionnaire, including abdominal pain, heartburn, belching acid, a feeling of sucking and burning in epigastria, nausea and vomiting. In general, there were no clinically significant differences between the frequency of occurrence and the severity of symptoms on the GSRS scale between group 2 and group 3, except for complaints of heartburn. So, RA patients of group 3 had a higher rate of heartburn feeling of 3.0 (2.0-3.0) points than patients of group 2 with 2.0 (1.0-2.0) points.</p><p><strong>Conclusion: </strong>The development of a EUL of the gastroduodenal zone in patients with RA is associated with low activity of inflammation in all studied slides, regardless of structurally destructive changes in the stomach and duodenum and compensatory hyperplastic reactions in the superficial layer of mucosa membrane, which can be determined by minimal subjective sensations or even complete absence of clinical manifestations with the formation of \"silent ulcers\", complicated by bleeding and perforation.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":"18 1","pages":"46-55"},"PeriodicalIF":1.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9620361","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Post-COVID-19 Gastro-Intestinal Disturbances.","authors":"Scarpellini E,&nbsp;Tack J","doi":"10.2174/1574887118666221201104833","DOIUrl":"https://doi.org/10.2174/1574887118666221201104833","url":null,"abstract":"<p><strong>Background: </strong>Since the end of 2019, SARS-CoV-2 has been responsible for the multisystemic hyper-inflammatory disease, namely, COVID-19, as a majorly impactful pandemic. Gastrointestinal (GI) symptoms occurring during and after disease are gaining increasing attention among experts.</p><p><strong>Methods: </strong>We briefly review and comment on preliminary and recent evidences on prevalence, pathophysiology, and perspective treatment options for GI disturbances during and after COVID-19.</p><p><strong>Results: </strong>Several reports from the literature show a significant portion of COVID-19 patients suffering from GI symptoms both at the early stages of the disease and after the end of it, sometimes for several months, namely \"long-COVID-19\" patients, irrespective of vaccination. An unsolved issue regarding COVID-19 is the association between GI symptoms and the outcome of COVID-19 patients. Several studies and metanalyses suggest a worse evolution of COVID-19 in patients presenting with GI symptoms. However, these data have not been agreed. Indeed, only one uniform observation can be found in the literature: patients with chronic liver disease have a worse outcome from COVID-19 infection. Upper and lower GI symptoms have similarities with postinfectious functional dyspepsia (FD) and irritable bowel syndrome (IBS). FD and IBS following infection are recognize as pathophysiological factor the gut microbial, which is a gut microbial quali- and quantitative unbalance, namely dysbiosis. Furthermore, several preliminary reports and ongoing clinical trials have shown gut microbiota modulation by pre-, pro- and postbiotics to be effective in changing and preventing COVID-19 natural course.</p><p><strong>Conclusion: </strong>GI symptoms characterize both long- and non-long-COVID-19 with a potentially significant impact on its natural course. Gut microbiota modulation seems to be a sensible target for disease treatment and/or prevention.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":"18 1","pages":"34-40"},"PeriodicalIF":1.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9635849","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prophylactic Agents for Preventing Cardiotoxicity Induced Following Anticancer Agents: A Systematic Review and Meta-Analysis of Clinical Trials.","authors":"Ehsan Keshavarzian,&nbsp;Tella Sadighpour,&nbsp;Seyed Mohammadreza Mortazavizadeh,&nbsp;Mohammadhossein Soltani,&nbsp;Amir Farzin Motevalipoor,&nbsp;Shahriyar Shahbazi Khamas,&nbsp;Mohammad Moazen,&nbsp;Mohammad Kogani,&nbsp;Seyed Mohammad Amin Hashemipour,&nbsp;Hamid Hosseinpour,&nbsp;Rohollah Valizadeh","doi":"10.2174/1574887118666230118102252","DOIUrl":"https://doi.org/10.2174/1574887118666230118102252","url":null,"abstract":"<p><strong>Background: </strong>Anthracyclines can improve survival in many types of malignancies, but dose-dependent and irreversible results following the use of anthracyclines have been associated with cardiomyopathy. This meta-analysis aimed to compare the effects of prophylactic agents for preventing cardiotoxicity induced following anticancer agents.</p><p><strong>Methods: </strong>In this meta-analysis, Scopus, Web of Science, and PubMed were surfed for articles published by December 30^th, 2020. The keywords were angiotensin-converting enzyme inhibitor (ACEI), enalapril, captopril, angiotensin receptor blocker, beta blocker, metoprolol, bisoprolol, isoprolol, statin, valsartan, losartan, eplerenone, idarubicin, nebivolol, dihydromyricetin, ampelopsin, spironolactone, dexrazoxane, antioxidants, cardiotoxicity, n-acetyl-tryptamine, cancer, neoplasms, chemotherapy, anthracyclines, doxorubicin, daunorubicin, epirubicin, idarubicin, ejection fraction or a combination of them in the titles or abstracts.</p><p><strong>Results: </strong>A total of 17 articles out of 728 studies examining 2,674 patients were included in this systematic review and meta-analysis. Ejection fraction (EF) values in the baseline, 6-month, and 12-month follow-up in the intervention group turned out to be 62.52 ± 2.48, 59.63 ± 4.85, and 59.42 ± 4.53, whereas in the control group appeared to be 62.81 ± 2.58, 57.69 ± 4.32, and 58.60 ± 4.58, respectively. Through comparison of the two groups, EF was found to increase in the intervention group by 0.40 after 6 months (Standardized mean difference (SMD): 0.40, 95% confidence interval (CI): 0.27, 0.54), thus proving higher than that of the control groups following the cardiac drugs.</p><p><strong>Conclusion: </strong>This meta-analysis showed that prophylactic treatment with cardio-protective drugs, including dexrazoxane, beta blocker, and ACEI drugs in patients undergoing chemotherapy with anthracycline, have a protective effect on LVEF and prevent EF drop.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":"18 2","pages":"112-122"},"PeriodicalIF":1.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9556754","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of Pregabalin as a Neural Pathway Inhibitor for the Treatment of Resistant Subacute and Chronic Cough: A Pilot Clinical Trials Study.","authors":"Seyed Hasan Adeli, Abolfazl Mohammad Beigi, Sajjad Ahmadpour, Mohammad Amin Habibi, Mohammad Reza Pashaei, Ehsan Sharifipour, Mansoureh Shakeri, Akram Asghari","doi":"10.2174/0115748871262516230919070559","DOIUrl":"10.2174/0115748871262516230919070559","url":null,"abstract":"<p><strong>Background: </strong>Cough hypersensitivity syndrome is one of the causes of chronic cough. Small clinical trials have suggested the effects of pregabalin as a neural pathway inhibitor in treating subacute and chronic cough resistance.</p><p><strong>Methods: </strong>This study is an 8-week, pilot study randomized, double-blind clinical trial on 30 patients' resistant to treatment of the underlying cause who were referred to an ultra-specialized lung clinic, Shahid Beheshti Hospital, between 2021-2022. The samples were randomly divided into control (dextromethorphan and placebo) and intervention (dextromethorphan and pregabalin). Patients were evaluated at the beginning, during, and after eight weeks of treatment, using the modified standard Leicester Cough Questionnaire (LCQ) regarding the changes and the rate of recovery compared to before Participation in the study.</p><p><strong>Findings: </strong>The quality of life score of patients eight weeks after treatment had a significant difference and was higher in the intervention group (In the pregabalin group) than in the control group (p =0.006). The recovery rate of cough in 26% of patients was equal to 70%, but others were reported up to 50%.</p><p><strong>Conclusion: </strong>Pregabalin increases the quality of life in patients with subacute and chronic cough resistant to standard treatment and increases the rate of recovery in these patients.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":"269-274"},"PeriodicalIF":1.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54230812","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of OM-85 in Recurrent Respiratory Tract Infections.","authors":"Pietro Gareri,&nbsp;Caterina Trevisan,&nbsp;Angela Marie Abbatecola,&nbsp;Alba Malara,&nbsp;Raffaele Antonelli Incalzi","doi":"10.2174/1574887118666230518112806","DOIUrl":"https://doi.org/10.2174/1574887118666230518112806","url":null,"abstract":"<p><strong>Background: </strong>In older patients, prevention of acute respiratory tract infections (RTIs) is challenging. Experimental studies have consistently underlined an immune-potentiating effect of the bacterial lysates product OM85, on both cellular and humoral responses.</p><p><strong>Objective: </strong>This work aimed to assess the potential efficacy of OM-85 for RTIs' prevention in older individuals.</p><p><strong>Methods: </strong>This explorative longitudinal study included 24 patients aged 65 years or older recruited in the GeroCovid Observational Study- home and outpatient care cohort. For the study purposes, we included 8 patients treated with OM-85 from December 2020 to June 2021 (group A), and a control group of 16 patients, matched for sex and age, who did not receive bacterial lysates (group B). RTIs were recorded from the participants' medical documentation in an e-registry from March 2020 to December 2021.</p><p><strong>Results: </strong>In 2020, group A experienced a total of 8 RTIs, which affected 6 out of 8 patients (75%); group B reported 21 RTIs, with at least one event in 11 out of 16 patients (68.7%). In 2021, RTIs affected 2 out of 8 patients (25%) in group A (p < 0.02), and 13 out of 16 patients (81.2%) in group B (within this group, 5 patients had two RTIs). The RTIs' cumulative incidence over the observation period significantly differed between groups (66.7% in group A vs. 24.3% in group B; p < 0.002), as well as the decrease in RTIs frequency from 2020 to 2021. No patients in group A were affected by COVID-19 during the observation period, while among controls, two patients had SARS-CoV-2 infection, notwithstanding three doses of vaccine.</p><p><strong>Conclusion: </strong>This study suggests that bacterial lysates may provide clinical benefits for preventing RTIs. Additional research involving larger cohorts is required to verify the effectiveness of OM-85 in preventing RTIs in older adults.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":"18 3","pages":"223-227"},"PeriodicalIF":1.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10197558","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Deficits of the Methodological and Reporting Quality of Randomized Controlled Trials in the Field of Prosthetics and Orthotics in Iran: A Systematic Review.","authors":"Saeed Shahabi,&nbsp;Carlotte Kiekens,&nbsp;Parviz Mojgani,&nbsp;Chiara Arienti,&nbsp;Shabnam ShahAli,&nbsp;Kamran Bagheri Lankarani","doi":"10.2174/1574887118666230221114201","DOIUrl":"https://doi.org/10.2174/1574887118666230221114201","url":null,"abstract":"<p><strong>Introduction: </strong>Due to the development of the academic field of prosthetics and orthotics (P&O) in recent years, scientific studies in this domain have increased. However, relevant published studies, especially randomized controlled trials (RCTs), are not always of acceptable quality. Therefore, this study aimed to evaluate the methodological and reporting quality of RCTs in the field of P&O in Iran to recognize existing shortcomings.</p><p><strong>Methods: </strong>Six electronic databases, including PubMed, Scopus, Embase, Web of Science, the Cochrane Central Register of Controlled Trials, and the Physiotherapy Evidence Database, were searched from January 1, 2000, to July 15, 2022. The Cochrane risk of bias tool was applied to evaluate the methodological quality of the included studies. In addition, the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist was used to assess the reporting quality of the included studies.</p><p><strong>Results: </strong>35 RCTs published from 2007 to 2021 were included in our final analysis. The methodological quality of 18 RCTs was poor, and the quality of the rest of the studies was good (n = 7) or fair (n = 10). In addition, the median score (IQR) of the reporting quality of RCTs in accordance with the CONSORT items was 18 (13-24.5) out of 35. The results of the relationship analysis indicated a moderate correlation between the CONSORT score and the publication year of the included RCTs. Nonetheless, there was a low correlation between the CONSORT scores and the journals' impact factors.</p><p><strong>Conclusion: </strong>The overall methodological and reporting quality of RCTs in the field of P&O in Iran was not found to be optimal. To enhance the methodological quality, some items should be considered more strictly, such as blinding of outcome assessment, allocation concealment, and random sequence generation. Furthermore, the criteria of CONSORT, as reporting quality checklist, should be adopted in writing the papers, especially methods-related items.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":"18 2","pages":"92-111"},"PeriodicalIF":1.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9550371","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk Factors for Prolonged Intensive Care Unit Stay in Patients with Hypercapnic Respiratory Failure.","authors":"Nurgul Naurzvai,&nbsp;Ayshan Mammadova,&nbsp;Gul Gursel","doi":"10.2174/1574887118666230320163229","DOIUrl":"https://doi.org/10.2174/1574887118666230320163229","url":null,"abstract":"<p><strong>Introduction: </strong>Hypercapnic respiratory failure (HRF) is one of the most frequent reasons for intensive care unit (ICU) admissions. In this study, we aimed to investigate the risk factors for prolonged ICU stay in HRF patients for longer than 7, 10, and 15 days.</p><p><strong>Methods: </strong>Impact of demographics, vitals at the admission, comorbid disease severity, respiratory parameters, admission diagnosis, noninvasive mechanical ventilation (NIV) application time and settings, arterial blood gas, and blood biochemistry results were analyzed in patients with HRF to investigate risk factors for longer ICU stay.</p><p><strong>Results: </strong>A total of 210 patients who were admitted to ICU with HRF (PaCO₂ values of 45 mmHg and higher) were included in this retrospective cohort study. The mean age of the patients was 69 ± 12 years, and the mean ICU duration was 9 ± 7 days. Forty-five percent of the patients stayed in the ICU for more than one week and 10% of them stayed for more than 15 days. Risk factors for a prolonged stay in ICU for more than 7 days were high SOFA score, acute renal failure (ARF) at admission, low PaO₂/FiO₂ on the 2^nd day of admission, and high TSH level. Low FEV1 and FEV1/FVC ratio, ARF at admission, and low PaO₂/FiO₂ ratio on the 2nd day of admission were found to be risk factors for prolonged stay in ICU for longer than 10 days. Significant risk factors prolonging the ICU duration for more than 15 days were high SOFA score, low FEV1, low FEV1/FVC ratio (p</i> = 0.008), and hypothyroidism (p</i> = 0.037). FEV1% predicted less than 25.5% and FEV1/FVC% less than 46.5% were significantly associated with ICU stay longer than 10 days.</p><p><strong>Conclusion: </strong>Earlier diagnosis and treatment of patients with hypothyroidism and severe airflow obstruction could shorten the length of ICU stay of hypercapnic patients.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":"18 2","pages":"129-139"},"PeriodicalIF":1.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10092870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hyponatremia Related to Neurocritical Care: Focus on Diagnosis and Therapy: A Systematic Review.","authors":"Gianluca Mezzini,&nbsp;Stefano Marasco,&nbsp;Alessandro Bertuccio,&nbsp;Gabriele Savioli,&nbsp;Fabio Piccolella,&nbsp;Fabrizio Racca,&nbsp;Andrea Barbanera,&nbsp;Matteo Vitali","doi":"10.2174/1574887118666221208161259","DOIUrl":"https://doi.org/10.2174/1574887118666221208161259","url":null,"abstract":"<p><strong>Introduction: </strong>Hyponatremia is the most frequently occurring electrolyte disorder in neurocritical care and traumatic brain injury, aneurysmal subarachnoid hemorrhage (SAH), neurosurgery, and ischemic stroke are the clinical conditions more often associated with this condition. SIADH and CSWS are the main causes of hyponatremia in neurologically ill patients. Since hyponatremia is a negative prognostic factor for neurocritical patients, early diagnosis and consequent targeted therapy are of fundamental importance. The present review was carried out to provide a brief recap on the main causes and management of hyponatremia in the neurocritical patient.</p><p><strong>Methods: </strong>A methodical search of the medical literature using the online database MEDLINE was carried out and studies comprising case reports, prospective and retrospective observational studies, or randomized controlled clinical trials in which there is a diagnosis of hyponatremia in neurocritical patients were included.</p><p><strong>Results: </strong>18 articles were analyzed, consisting of 8 case reports, 4 case series, 3 prospective trials, 1 retrospective study, and 1 multicenter trial. A total of 1371 patients from 18 studies were included. Patients' average age was 29.28 ± 20.9, respectively. TBI was the main cause of hyponatremia in the literature reviewed; 12 studies were about the relationship between TBI and hyponatremia, 2 studies about stroke, 2 studies about SAH and 1 about hyponatremia postneurosurgical procedure.</p><p><strong>Discussion: </strong>Hyponatremia is the most common electrolyte disorder in hospitalized patients and the main scenarios of hyponatremic neurocritical patients are subarachnoid hemorrhage, ischemic stroke, traumatic brain injury and iatrogenic hyponatremia due to neurosurgical cases.</p><p><strong>Conclusion: </strong>Hyponatremia is a frequent finding in neurocritical care and is also a recognized negative prognostic factor leading to increased mortality and ICU length hospitalization. Its diagnosis and therapy are essential for correct neurocritical management. The most common cause of serum sodium abnormality is SIADH, and an early diagnosis for target treatment is paramount to prevent delayed symptoms and complications.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":"18 1","pages":"19-27"},"PeriodicalIF":1.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9635858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Composite Quality Score (CQS) as an Appraisal Tool for Prospective, Controlled Clinical Therapy Trials: Rationale and Current Evidence.","authors":"Steffen Mickenautsch,&nbsp;Stefan Rupf,&nbsp;Ivana Miletić,&nbsp;Veerasamy Yengopal","doi":"10.2174/1574887118666230104152245","DOIUrl":"https://doi.org/10.2174/1574887118666230104152245","url":null,"abstract":"<p><strong>Background: </strong>Current evidence appraisal concepts, such as the Assessment, Development and Evaluation (GRADE) approach and Cochrane's Risk of Bias (RoB) tool, rely on assumptions related to the classic problem of inductive reasoning and may suffer from insufficient inter-rater reliability.</p><p><strong>Discussion: </strong>The Composite Quality Score (CQS) has emerged as a possible trial appraisal tool that does not rely on inductive assumptions and has been shown to be of potentially very high inter-rater reliability.</p><p><strong>Conclusion: </strong>Although the current CQS concept is still under development, its current evidence is encouraging and justifies further study. This article presents the rationale and currently available research concerning the CQS and shows where further research is required.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":"18 1","pages":"28-33"},"PeriodicalIF":1.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9267963","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient-Reported Outcomes for the Assessment of Sexual Health Among Patients Affected by Inflammatory Bowel Disease.","authors":"Daniela Pugliese,&nbsp;Laura Parisio,&nbsp;Tommaso Schepis,&nbsp;Giuseppe Privitera,&nbsp;Valentin Calvez,&nbsp;Antonio Gasbarrini,&nbsp;Alessandro Armuzzi","doi":"10.2174/1574887117666220630114054","DOIUrl":"https://doi.org/10.2174/1574887117666220630114054","url":null,"abstract":"<p><p>Patients affected by inflammatory bowel disease (IBD) frequently report impaired quality of sexual life and complain of sexual dysfunctions. Both disease-specific features and psychological factors can be held responsible for these conditions. However, sexuality and all matters relating to sexual health are often wrongfully considered unrelated to IBD and, therefore, overlooked during medical visits. To overcome these difficulties and to best assess patients' perceptions about their sexual health status, the use of patient-reported outcomes (PROs) could represent a valid strategy. In real-world studies, several non-IBD specific questionnaires, exploring different domains of sexuality, have been applied and validated for the IBD population. This review summarizes the available evidence on sexual health among IBD patients and the data supporting the application of PROs to screen the quality of sexual life, as well as the rate and types of sexual dysfunctions, among IBD patients.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":"17 4","pages":"250-258"},"PeriodicalIF":1.9,"publicationDate":"2022-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10523230","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}