High Quality RCT Research Articles

The effects of psychological interventions on suicide for cancer patients: a systematic review and network meta-analysis

ABSTRACT Numerous psychological interventions are available for suicidal and death ideation (SDI) and suicidal behavior among cancer patients. To identify the optimal psychological interventions for reducing SDI and suicidal behavior in cancer patients. However, it remains unclear which psychological intervention is the most effective. We performed a pairwise and network meta-analysis by searching seven databases from the date of inception until 8 April 2022. An important focus of this network meta-analysis was the comparison of the effects of various psychological interventions on the reduction of SDI and suicidal behavior among cancer patients. For determining efficacy, we used standardized mean differences (SMDs) and 95% confidence intervals (CIs). Besides, a pairwise meta-analysis, inconsistency test, network meta-analysis, the surface under the cumulative rankings curve (SUCRA), comparison-adjusted funnel plot, subgroup analysis, and sensitivity analysis were also carried out. A total of 8 studies involving 1,350 patients were searched in this study. It showed that empathy therapy (SUCRA = 95.3%) has the best effect among the six interventions. Comprehensive psychological intervention (SUCRA = 77.6%) was ranked in the top two positions, followed by meaning-centered therapy (SUCRA = 40.7%). Comparison-adjusted funnel plots revealed no significant publication bias. In addition, our conclusions have not changed significantly after the sensitivity analysis. In this network meta-analysis, empathy therapy was identified as the optimal choice for reducing SDI and suicidal behaviors in cancer patients. Further multi-center and high-quality RCT studies should be conducted to make our conclusion more rigorous.

Suture Button Fixation for Lisfranc Injuries: A Systematic Review

Category: Midfoot/Forefoot; Trauma Introduction/Purpose: Lisfranc injuries remain a significant but often misdiagnosed orthopaedic injury. Alongside traditional methods of surgical fixation, including arthrodesis and ORIF with screws, suture button fixation is an emerging technique. While several studies have reviewed the outcomes of Lisfranc injuries utilizing plate, screw, and k-wire constructs for arthrodesis or ORIF, there has yet to be a review of the literature focusing on suture button fixation outcomes of Lisfranc injuries. The purpose of this systematic review is to consolidate studies utilizing suture button fixation for the treatment of Lisfranc injuries. Methods: A comprehensive literature review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) using PubMed, Embase, Web of Science, and Cochrane databases for original, English-language studies observing outcomes of Lisfranc injury until August 19, 2022. This combination search strategy employed the following keywords: ((Lisfranc OR Midfoot OR Tarsometatarsal) AND (Injury OR Instability OR Fracture OR Dislocation)) AND (ORIF OR Fixation OR Reconstruction OR suture* OR button* OR Fiber*). The quality of all included studies in this review was evaluated by a modified Coleman score. Clinical outcomes including pre and postoperative American Orthopaedic Foot and Ankle Society (AOFAS) score, pre and postoperative Visual Analogue Scale (VAS) for pain, and radiographic outcomes such as diastasis were extracted from the text and figures of each study. Return to sports/duty and time to return as well as postoperative complication diagnoses and complications were also extracted from each article. Results: Of the 10 studies included, there were 186 total patients with an age range of 13-72. In every study, all patients were able to return to sport or activity with a return time averaging from 10.8-55.1 weeks. Postoperative AOFAS scores ranged from 83.5- 97 while VAS ranged from 0.6-2.5. Complications were reported in six studies at a rate of 6.7 % including two cases of diastasis, two cases of paresthesia, one case of button irritation, and one of postoperative degenerative joint disease, with no reported revisions. Conclusion: This study summarizes the current evidence regarding suture button fixation of Lisfranc injuries including return to sport, postoperative diastasis, and patient-reported outcomes. In sum, these studies found that suture button fixation shows high levels of patient-reported outcomes, return to sport, and stable fixation in isolated Lisfranc injuries. This surgical technique is advantageous as it provides a more physiologic reduction across the Lisfranc joint and reduces the need for reoperation including the removal of hardware. Further evidence such as large sample size and high-quality RCT studies is needed to draw a definitive conclusion regarding the best treatment for Lisfranc injuries.

The Efficacy of Intercostal Nerve Block in the Management of Postoperative Pain After Costal Cartilage Harvest for Craniofacial Reconstruction Systematic Review and Meta-analysis.

Autologous costal cartilage harvest is a common procedure in craniofacial reconstruction due to its stability, dependability, and diversity. However, such a procedure is associated with severe donor-site pain postoperatively. Therefore, we aim through this study to compare the efficacy of intercostal nerve block in the management of postoperative pain in patients undergoing costal cartilage harvest for craniofacial reconstruction. This systematic review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines. The study systematically reviewed MEDLINE, Cochrane, and EMBASE databases without time-limitation. As a result of reviewing the literature, 33 articles were screened by full-text resulting in 14 articles which met our inclusion/exclusion criteria. However, only four high-quality RCT articles were included in the quantitative synthesis (meta-analysis). The findings of this study suggest that there is no significant difference in pain scores between ICNB and control groups at 12, 24, and 48h postoperatively, both at rest and with coughing. Therefore, both techniques are considered safe and effective. Our results show evidence of favorable outcome of preventive donor-site analgesia with ICNB for harvesting autologous costal cartilage in multiple studies. However, the overall outcomes were insignificant between the two arms. This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Evaluation of the impact of a self-stigma reduction programme on psychosocial outcomes among people with schizophrenia spectrum disorder

PurposeThe purpose of this study is to evaluate the effectiveness of a self-stigma reduction programme on self-stigma.Design/methodology/approachA randomized controlled trial was conducted from November 2017 to December 2018 with 278 people diagnosed with schizophrenia (PDwS). Participants were randomly assigned to receive a self-stigma reduction programme (psychoeducation, cognitive behavioural therapy and social skills training) or treatment as usual.FindingsPDwS in the intervention group experienced a greater reduction in the level of self-stigma (20.19 vs −0.62; p < 0.001) at post-intervention and (37.35 vs −0.66; p < 0.001) at six-month follow-up.Originality/valueThe first RCT examines the problem and implements intervention in middle east country. Also, the authors have conducted high-quality RCT.

Effect of pelvic floor muscle training on reports of urinary incontinence in obese women undergoing a low-calorie diet before bariatric surgery — protocol of a randomized controlled trial

BackgroundObesity represents a growing threat to health with multiple negative impacts including urinary incontinence. Pelvic floor muscle training (PFMT) is the first line of treatment for urinary incontinence. Both surgical and conservative weight loss results in improvement of urinary incontinence reports in obese women and we hypothesize that a low-calorie diet in combination with PFMT would result in additional beneficial effects to urinary symptoms in women with UI compared would with weight loss alone.ObjectiveTo assess the effect of a low-calorie diet plus PFMT protocol in obese women’s urinary incontinence reports.MethodsThis is a protocol for a randomized controlled trial that will include obese women reporting UI and being able to contract their pelvic floor muscles. The participants will be randomly allocated in two groups: group 1 will participate in a 12-week protocol of low-calorie diet delivered by a multi-professional team at a tertiary hospital; group II will receive the same low-calorie diet protocol during 12 weeks and will additionally participate in 6 group sessions of supervised PFMT delivered by a physiotherapist. The primary outcome of the study is self-reported UI, and severity and impact of UI on women’s quality of life will be assessed by the ICIQ-SF score. The secondary outcomes will be adherence to the protocols assessed using a home diary, pelvic floor muscle function assessed by bidigital vaginal palpation and the modified Oxford grading scale, and women’s self-perception of their PFM contraction using a questionnaire. Satisfaction with treatments will be assessed using a visual analog scale. The statistical analysis will be performed by intention to treat and multivariate analysis of mixed effects will be used to compare outcomes. The complier average causal effects (CACE) method will be used to assess adherence. There is an urgent need for a high-quality RCT to investigate if the association of a low-calorie diet and PFMT can provide a larger effect in the improvement of urinary incontinence reports in women with obesity.Trial registrationClinical Trials NCT04159467. Registered on 08/28/2021.

Adding caplacizumab to standard of care in thrombotic thrombocytopenic purpura: a systematic review and meta-analysis.

Immune thrombotic thrombocytopenic purpura (iTTP) is an acquired, fatal microangiopathy if untreated. Randomized controlled trials (RCTs) demonstrated faster time to response with addition of caplacizumab to standard of care (SOC). However, concerns about RCT selection bias and the high cost of caplacizumab warrant examination of all evidence, including real-world observational studies. In this systematic review and meta-analysis, we searched for comparative studies evaluating SOC with or without caplacizumab for the treatment of iTTP. We assessed risk of bias using the Cochrane risk-of-bias-2 tool (RCTs) and the Newcastle-Ottawa Scale (observational studies). The primary efficacy and safety outcomes were all-cause mortality and treatment-emergent bleeding, respectively. Secondary outcomes included exacerbation and relapse, refractory iTTP, and time to response. We included 2 high-quality RCTs and 3 observational studies at high risk of bias comprising 632 total participants. Compared with SOC, caplacizumab was associated with a nonsignificant reduction in the relative risk [RR] of death in RCTs (RR, 0.21; 95% confidence interval [CI], 0.05-1.74) and observational studies (RR, 0.62; 95% CI, 0.07-4.41). Compared with SOC, caplacizumab was associated with an increased bleeding risk in RCTs (RR, 1.37; 95% CI, 1.06-1.77). In observational studies, bleeding risk was not significantly increased (RR, 7.10; 95% CI, 0.90-56.14). Addition of caplacizumab was associated with a significant reduction in refractory iTTP and exacerbation risks and shortened response time but increased relapse risk. Frontline addition of caplacizumab does not significantly reduce all-cause mortality compared with SOC alone, although it reduces refractory disease risk, shortens time to response, and improves exacerbation rates at the expense of increased relapse and bleeding risk.

Association of nonpharmacological interventions for cognitive function in older adults with mild cognitive impairment: a systematic review and network meta-analysis.

Understanding the effectiveness of nonpharmacological interventions to improve cognitive function in older adults with MCI and identifying the best intervention may help inform ideas for future RCT studies and clinical decision-making. The main focus of this study was to assess the comparative effectiveness of nonpharmacological interventions on cognitive function in older adults with MCI and to rank the interventions. RCT studies until September 2022 were searched from six databases, including PubMed, the Cochrane Library, Embase, Web of Science, PsycINFO and CINAHL. The risk of bias in eligible trials was evaluated using the Cochrane Risk of Bias tool. Both pairwise and network meta-analyses were used, and pooled effect sizes were reported using SMD and the corresponding 95% confidence intervals. A total of 28 RCT studies were included in this study, pooling 18 categories of nonpharmacological interventions. MBE (mind-body exercise) (SMD (standard mean difference): 0.24, 95% CI: 0.08-0.41, P = 0.004), DTE (dual-task exercise) (SMD: 0.61, 95% CI: 0.09-1.13, P = 0.02), PE (physical exercise) (SMD: 0.58, 95% CI: 0.04-1.12, P = 0.03) may be effective in improving cognitive function in older adults with MCI. Acupressure + CT (cognitive training) was the top-ranked intervention among all interventions. No greater benefits of MA (mindful awareness) on cognitive function were found. Overall, nonpharmacological interventions significantly improved cognitive function in older adults with MCI. Acupressure + CT(cognitive training) was the most effective intervention for managing cognitive impairment. Future studies with high quality and large sample size RCT studies are needed to confirm our results.

Meta Analysis of Mesalazine Combined with Chinese Herbal Compound Enema in the Treatment of Ulcerative Colitis

To evaluate the clinical efficacy of mesalazine combined with Chinese herbal compound enema in the treatment of ulcerative colitis, we searched CNKI, Wangfang, VIP, CBM, The Cochrane Libarary, Pubmed, Web of Science and EMBase databases. Randomized controlled trials (RCTS) about mesalazine combined with TCM compound enema for ulcerative colitis were randomized controlled trials (RCTS), all randomized controlled trials were conducted from database establishment to August 2022, in which control group received mesalazine treatment, and treatment group received TCM reenema on the basis of control group. The "risk bias assessment" tool provided by the Cochrane Reviewer's Handbook was used for literature quality assessment, and RevMan5.3 software was used for statistical analysis. Eleven literatures were finally included, all of which were randomized controlled trials with a total of 1029 patients. The results of meta-analysis showed that the clinical effective rate of the treatment group [RR=4.26, 95%CI (2.79,6.50), P<0.00001] was higher than that of the control group. It can effectively reduce Baron score [MD=-0.98, 95%CI (-1.25, -0.71), P<0.00001], DAI score [MD=-1.61, 95%CI (-1.81, -1.42), P<0.00001], CRP value [MD=-6.61, 95%CI (-7.29. 56,-5.93), P<0.00001], the treatment group was more effective than the control group in relieving clinical symptoms, including abdominal pain [MD=-1.03, 95%CI (-1.99, -0.07), P = 0.03), diarrhea (MD = 0.86, 95% CI (1.46, 0.25), P = 0.006), and purulent blood [MD = 0.86, 95% CI (1.62, 0.09), P = 0.03). Funnel plot of clinical response rate showed obvious asymmetry between left and right, suggesting possible publication bias. Mesalazine combined with Chinese herbal compound enema has significant clinical efficacy in the treatment of ulcerative colitis, but the literature included is too few and the quality evaluation is not high, so it needs to be further confirmed by multiple books and high-quality RCT tests in the future.

META analysis on the effect of taijiquan on improving negative psychological symptoms of college students and the optimal dose.

Taijiquan, as a physical and mental exercise, can improve the negative psychology of college students. However, it is still controversial, and the optimal exercise dose of taijiquan to interfere with negative psychology has not been evaluated. This study is aimed at systematically evaluating the effect of taijiquan therapy on improving negative psychological symptoms of college students and its optimal intervention dose. Search databases such as Web of Science, Embase, PubMed, CNKI, WFSD, etc. Collect high-quality relevant RCT studies. After screening, extracting, coding and counting the data, a META analysis is done through Review Manage 5.3 and Stata 15.0 software. PICOS established the eligibility criteria to select the studies as follows: (i) population - non-clinical of college students; (ii) intervention - taijiquan intervention; (iii) comparison - taijiquan intervention group and regular physical activity group; (iv) outcomes - depression, anxiety; and (v) study design - randomized controlled trial. A total of 12 articles and 1,000 samples were included. All of the participants are college students. Taijiquan therapy can significantly reduce the depression and anxiety symptoms of college students [SMD = -0.53, 95% CI (-0.82, -0.23)], [SMD = -0.49, 95% CI (-0.90, -0.09)], with statistical significance (P < 0.05). Subgroup analysis shows that: there is a precise focus on depression and anxiety symptoms. The intervention period is more than 12 weeks, and the best effect appears when people practice 3 times a week. The best single intervention time for depression symptoms is 60 min, and for anxiety symptoms 80-90 min. It is found that taijiquan combined with mindfulness intervention can significantly reduce negative psychological symptoms like depression and anxiety of college students than single taijiquan intervention. Funnel plot combined with sensitivity analysis, Begg, Egger test showed no publication bias. Taijiquan intervention can effectively improve the negative psychological symptoms of college students, and it has great promotion value in colleges and universities. https://www.crd.york.ac.uk/PROSPERO/, identifier: CRD42022314071.

Contribution of Chinese herbal medicine in the treatment of coronavirus disease 2019 (COVID-19): A systematic review and meta-analysis of randomized controlled trials.

Coronavirus disease 2019 (COVID-19) has become a global epidemic, and there is no specific treatment for anti-COVID-19 drugs. However, treatment of COVID-19 using Chinese herbal medicine (CHM) has been widely practiced in China. PubMed, Embase, Cochrane Library, CNKI, Wanfang and VIP databases were searched to evaluate the efficacy and safety of CHM in the treatment of COVID-19. Twenty-six studies were included in this meta-analysis. The included cases were all patients diagnosed with COVID-19 according to the "New Coronary Virus Pneumonia Diagnosis and Treatment Program," with a total of 2,407 cases. Patients were treated with CHM, including 36 prescriptions, and 105 flavors of CHM were included. The results of the meta-analysis showed that the CHM group improved in lung CT, clinical cure rate, clinical symptom score and time to negative for viral nucleic acid. However, this study still has many limitations due to the limited number of included studies. Therefore, high-quality RCT studies are needed to provide more reliable evidence for CHM treatment of COVID-19. In conclusion, CHM may significantly improve the clinical manifestations and laboratory indicators of patients with COVID-19. In addition, no serious adverse reactions were found after CHM treatment. Therefore, CHM may be used as a potential candidate for COVID-19. HIGHLIGHTS: COVID-19 has become a global epidemic, and there is no specific treatment for anti-COVID-19 drugs. CHM has made a new breakthrough in the treatment of COVID-19. CHM may relieve lung CT images of COVID-19 patients. CHM may improve clinical symptoms of COVID-19 patients. CHM may inhibit the expression of inflammatory factors in patients with COVID-19.

Systematic literature review on surgical site preparation in paediatric surgery

BackgroundSurgical site infections (SSIs) in children represent a common and serious postoperative complication. Surgical skin preparation is an essential preventive measure in every surgical procedure. The most commonly used antiseptic agents for surgical skin preparation are chlorhexidine gluconate and iodophors in alcohol-based solutions. In adult patients the use of chlorhexidine-containing antiseptic solutions for preoperative skin preparation has been advocated to reduce SSI rates. Our objective was to conduct a systematic literature review on use of antiseptic agents for surgical skin preparation in children less than 16 years of age.MethodsA systematic review of MEDLINE, EMBASE, CINAHL and CENTRAL was performed using both MeSH and free text terms and using the relevant Cochrane filter to identify full text randomized trials (RCTs) and comparative observational studies. Interventions of interest were the choice of main agent in antiseptic solutions (chlorhexidine/povidone-iodine/alcohol) compared with each other or with other antiseptic agents. Primary outcome was the reported rate of surgical site infections.ResultsIn total 8 studies were included in the review; 2 RCTs and 6 observational studies. Observational studies generally did not primarily investigate the association of different antiseptics with subsequent SSI. The identified randomised controlled trials included only 61 children in total, and were of low quality. Consequently, we did not conduct a formal meta-analysis. Since the publication of a comprehensive systematic review of perioperative measures for the prevention of SSI in 2016, no randomized controlled trials comparing antiseptic agents for surgical skin preparation in paediatric surgery have been conducted.ConclusionRobust evidence on the optimal skin antisepsis to reduce SSIs in children is lacking. Direct extrapolation of effects from trials involving adults is not appropriate as physiologic characteristics and risk factors for SSIs differ between adults and children. It is therefore essential to conduct high quality RCT investigating interventions to identify optimal measures to reduce SSI rates in children.Trial registrationProspero registration (CRD42020166193).

Effect of Baihu and Guizhi decoction in acute gouty arthritis: study protocol for a randomized controlled trial

BackgroundThe prevalence rates of gout worldwide have increased annually. Acute gouty arthritis (AGA) accounts for a large proportion of gout patients and causes severe physical and mental pain in patients. Controlling the occurrence and development of gout inflammation is the first step in the treatment of gout. The main treatment drugs in gout are non-steroid anti-inflammatory drugs (NSAIDs), colchicine, and glucocorticoids, but these treatments have many adverse reactions which limit their clinical application. Baihu and Guizhi decoction (BHGZ) is one of the classic prescriptions in the Synopsis of the Golden Chamber and is a good prescription for AGA. Previous clinical studies have shown that BHGZ confers a strong benefit for treating AGA. However, the literature shows a lack of high-quality RCT research on BHGZ with respect to AGA. Therefore, in this study, we use a randomized, double-blind, controlled study with a placebo to evaluate the clinical efficacy and safety of BHGZ on the AGA of moist heat arthralgia spasm syndrome.MethodsThis study is a randomized, double-blind, controlled clinical trial. A total of 102 adult participants with AGA of moist heat arthralgia spasm syndrome will be enrolled, with balanced treatment allocation (1:1). The experimental intervention will be BHGZ plus the low-dose colchicine, and the control intervention will be placebo plus the low-dose colchicine for 10 days. To study the clinical efficacy (including VAS score; joint tenderness, joint swelling, joint movement disorder; TCM evidence efficacy score) and the changes of inflammatory indexes. At the same time, the improvement of joint inflammation in patients with AGA will be observed from musculoskeletal ultrasound imaging, and the safety evaluation will be carried out.DiscussionThis study will be the first placebo-controlled RCT to assess whether BHGZ plus low-dose colchicine have beneficial effects on changing reducing inflammation of joints for patients with AGA of moist heat arthralgia spasm syndrome. The results of this trial will help to provide evidence-based recommendations for clinicians.Trial registrationChinese Clinical Trials Register ChiCTR1900024974. Registered on 5 August 2019

Efficacy and safety of Huazhi Rougan granule in the treatment of non-alcoholic fatty liver: a systematic review and meta-analysis.

This study aims to systematically assess the effectiveness and safety of Huazhi Rougan granule in the treatment of non-alcoholic fatty liver. The PubMed, Cochrane Library, EMBASE, China National Knowledge Infrastructure (CNKI), WanFang databases, VIP databases, Chinese Biomedical Literature Database (SinoMed) were searched to identify the relevant randomized controlled trials, from the establishment of the database to June 7, 2020. The Cochrane risk of bias tool for assessing risk of bias was employed to evaluate the quality of the literatures included. Meta-analyses were performed using RevMan 5.3 software. A total of 23 related literature were retrieved, 9 studies with 1,142 participants were included in the meta-analysis. The overall quality of evidence for this study is low. Meta-analysis results suggest that, Huazhi Rougan granule combined with conventional treatment was significantly superior to the silybin control group in the improvement of liver B-ultrasound, reduction of serological indexes, increase of high-density lipoprotein and total clinical effective rate, which was statistically significant. The improvement of serum lipid parameters included alanine aminotransferase (ALT): [mean deviation (MD) =-10.49, 95% confidence interval (CI): -17.09, -3.90, P<0.05], aspartate transaminase (AST): (MD =-9.44, 95% CI: -14.62, -4.26, P<0.05), total cholesterol (TC): (MD =-0.77, 95% CI: -0.94, -0.60, P<0.05), triglyceride (TG): (MD =-0.40, 95% CI: -0.56, -0.24, P<0.05). Reduce low-density lipoprotein cholesterol: (MD =-0.40, 95% CI: -0.56, -0.24, P<0.05). Clinical effective rate: [risk ratio (RR) =1.25, 95% CI: 1.16, 1.36, P<0.05]. Occurrence of adverse reactions: Of the 9 studies included, 5 reported adverse reactions, of which 3 reported no drug-related adverse reactions. Adverse reactions were reported in 2 cases, all of which were mild adverse reactions. The clinical efficacy of Huazhi Rougan granule combined with conventional basic therapy in the treatment of non-alcoholic fatty liver may be better than that of conventional basic therapy combined with silybin, which may improve the B-ultrasonic grading effect of the liver and reduce the serum lipid parameters of the patients. it may improve the clinical symptoms of non-alcoholic fatty liver, and the incidence of adverse reactions is low, but the number of existing clinical studies is small and the quality is low, in order to further verify the above conclusions. More high-quality clinical RCT trials need to be carried out, and internationally recognized outcome indicators should be selected and uniformly included in the scoring criteria.

Meta-analysis of the Effect of Shenfu Injection on Immune Function in Patients with Sepsis

Objective: To systematically evaluate the effects of Shenfu Injection on immune function of sepsis patients by meta-analysis. Methods: The randomized controlled trials of Shenfu Injection in the treatment of sepsis published from 2000 to February 2021 were searched in CNKI, WanFang database and VIP database. The control group was treated with routine treatment; The experimental group was treated with Shenfu Injection on the basis of routine treatment. The included literature was evaluated by Cochrane bias risk evaluation table, and Shenfu Injection was used to treat patients with sepsis with RevMan 5.3 software. The results of meta-analysis were as reported. Conclusion: However, due to the limitation of the quality and quantity of the included research, multi center, large sample volume and high-quality RCT are still needed to verify the research results.

膵癌の外科治療

We provide here an outline of adjuvant and neoadjuvant treatment along with surgery from the viewpoint ofthe change in pancreatic cancer survival. Since 2000, gemcitabine and S-1 have been authorized, and gemcitabinehas been chosen for adjuvant treatment. We performed a high-quality RCT of S-1 in the adjuvant setting startingin 2014 and became the leading center for adjuvant treatment. We used resectability criteria that were annuallyreported by the American NCCN, but they were introduced in the 7th edition of the JPS guidelines in this countryand are useful for decision-making orientation. Neoadjuvant chemotherapy is a commonly recognized methodfor the management of patients with resectable and borderline resectable pancreatic tumors. However, there hasnot yet been a consensus on the best regimen choice. A RCT of preoperative chemotherapy including S-1 + GEMtreatment was performed in patients with resectable tumors in 2019, and an improvement in the long-term survivalwas demonstrated. We retrospectively evaluated the cases of patients undergoing pancreatic cancer excision at ourinstitution over the past 24 years. On the basis of resectability (R) criteria classifications, preoperative treatmentwas initiated in 38.4% of patients with UR and 53.8% of patients with BR tumors. The OS was 12.3% for patientswith BR tumors, 28.1% for those with R tumors and 24.9% for patients with UR (P = 0.038) tumors. An improvement in the survival rate was observed with adjuvant treatment. Successful execution of adjuvant treatment withS-1 contributed to long-term survival after surgery without cancer remnants. However, it is essential to preoperatively treat patients with UR tumors to control 20% of recurrences, and there is a high recurrence of cancer inpatients with BR tumors treated with chemotherapy. These treatments performed preoperatively can lead to animprovement in OS.

Comprehensive Analysis of Clinical Trials Registration for Lupus Nephritis Therapy on ClinicalTrials.gov.

Objective: Clinical trials are the most effective method for evaluating therapeutic strategies. The purpose of this study was to comprehensively assess the characteristics of trials on lupus nephritis (LN) and provide a reference for LN treatment and research.Methods: Registered therapeutic trials on drug interventions for LN were obtained from ClinicalTrials.gov up to December 3, 2020. The general characteristics, methodological characteristics, detailed characteristics, investigated drugs, eligibility criteria, and outcome measures of these trials were analyzed.Results: A total of 126 eligible trials were evaluated, and these trials mainly investigated the initial treatment of adult proliferative LN. Half of the trials enrolled <50 participants, and 70.7% of the trials lasted for 6–24 months. In total, 95.2% of trials adopted an interventional study design. Of intervention trials, 56.6% were in phase 2 or phase 3, 76.7% were randomized, 77.5% employed a parallel assignment, and 41.7% were masked. The eligibility criteria and outcome measures of the included trials varied and involved a variety of indicators. Chemical agents and biologics are the most widely studied immunotherapies, of which mycophenolate mofetil, tacrolimus, and rituximab are the most studied. In addition, some trials studied cell transplantation treatment.Conclusions: The majority of clinical trials for LN therapy registered on ClinicalTrials.gov investigated the initial treatment of adult proliferative LN, and most of these trials were randomized, parallel assigned, and insufficiently masked interventional trials with small scale, short duration, various eligibility criteria, and outcome measures. We hope that more large-scale, long-term multicenter, and high-quality RCT trials with standardized inclusion criteria/exclusion criteria and treatment effect evaluation systems will be conducted and that more energy and funding will be put into exploring biological products and stem cell therapies. In addition, trials for membranous LN, childhood-onset LN, and maintenance phase LN are needed to establish optimal treatment strategies.

Bias estimation in study design: a meta-epidemiological analysis of transcatheter versus surgical aortic valve replacement

BackgroundPaucity of RCTs of non-drug technologies lead to widespread dependence on non-randomized studies. Relationship between nonrandomized study design attributes and biased estimates of treatment effects are poorly understood. Our purpose was to estimate the bias associated with specific nonrandomized study attributes among studies comparing transcatheter aortic valve implantation with surgical aortic valve replacement for the treatment of severe aortic stenosis.ResultsWe included 6 RCTs and 87 nonrandomized studies. Surgical risk scores were similar for comparison groups in RCTs, but were higher for patients having transcatheter aortic valve implantation in nonrandomized studies. Nonrandomized studies underestimated the benefit of transcatheter aortic valve implantation compared with RCTs. For example, nonrandomized studies without adjustment estimated a higher risk of postoperative mortality for transcatheter aortic valve implantation compared with surgical aortic valve replacement (OR 1.43 [95% CI 1.26 to 1.62]) than high quality RCTs (OR 0.78 [95% CI 0.54 to 1.11). Nonrandomized studies using propensity score matching (OR 1.13 [95% CI 0.85 to 1.52]) and regression modelling (OR 0.68 [95% CI 0.57 to 0.81]) to adjust results estimated treatment effects closer to high quality RCTs. Nonrandomized studies describing losses to follow-up estimated treatment effects that were significantly closer to high quality RCT than nonrandomized studies that did not.ConclusionStudies with different attributes produce different estimates of treatment effects. Study design attributes related to the completeness of follow-up may explain biased treatment estimates in nonrandomized studies, as in the case of aortic valve replacement where high-risk patients were preferentially selected for the newer (transcatheter) procedure.

Evaluating the effectiveness of patient tailored treatment for patients with non-specific low back pain: A systematic review.

This systematic review summarizes the relevant literature on the effectiveness of tailored interventions in non-specific low back pain (NSLBP). The search strategy has been executed in December 2019 in the electronic databases PubMed, Web of Science and Embase. Study selection, data extraction and quality assessment were done independently by two authors. A total six eligible studies were identified. Five out of six articles used a classification system to subgroup patients. All active patient tailored interventions had similar or better results than the non-patient tailored interventions, most importantly on pain (short- and mid-term, not for long term follow-up). Two motor control interventions revealed sustained or increased effects at 12months follow-up for disability. For cost-effectiveness, medication use and work absenteeism, results were inconclusive. Global rating of change evaluation confirmed significant between-group results at 10weeks to 4months follow-up, but results were not maintained at 12-month evaluation. DISCUSSION& CONCLUSION: Our findings support the preliminary evidence for the use of patient tailored treatment for reductions in pain and disability. However, our results are of very low to moderate quality evidence and the observed effects strongly depend on the subgroups and the chosen interventions. More high-quality RCT's with homogenous designs and larger sample sizes are needed.

Community health worker interventions for older adults with complex health needs: A systematic review.

The number of older adults with complex health needs is growing, and this population experiences disproportionate morbidity and mortality. Interventions led by community health workers (CHWs) can improve clinical outcomes in the general adult population with multimorbidity, but few studies have investigated CHW-delivered interventions in older adults. We systematically reviewed the impact of CHW interventions on health outcomes among older adults with complex health needs. We searched for English-language articles from database inception through April 2020 using seven databases. PROSPERO protocol registration CRD42019118761. Any U.S. or international setting, including clinical and community-based settings. Adults aged 60 years or older with complex health needs, defined in this review as multimorbidity, frailty, disability, or high-utilization. Interventions led by a CHW or similar role consistent with the American Public Health Association's definition of CHWs. Pre-defined health outcomes (chronic disease measures, general health measures, treatment adherence, quality of life, or functional measures) as well as qualitative findings. Of 5671 unique records, nine studies met eligibility criteria, including four randomized controlled trials, three quasi-experimental studies, and two qualitative studies. Target population and intervention characteristics were variable, and studies were generally of low-to-moderate methodological quality. Outcomes included mood, functional status and disability, social support, well-being and quality of life, medication knowledge, and certain health conditions (e.g., falls, cognition). Results were mixed with several studies demonstrating significant effects on mood and function, including one high-quality RCT, while others noted no significant intervention effects on outcomes. CHW-led interventions may have benefit for older adults with complex health needs, but additional high-quality studies are needed to definitively determine the effectiveness of CHW interventions in this population. Integration of CHWs into geriatric clinical settings may be a strategy to deliver evidence-based interventions and improve clinical outcomes in complex older adults.

Unmet needs in Chronic Pain Management: The potential use of Curcumin

The ultimate goal of treatment for osteoarthritis can be achieved by modifying disease progression and also symptom reduction. Non-steroidal anti-inflammatory drugs and cyclooxygenase-2 inhibitors are inflammation and pain management medications that are widely used in osteoarthritis. However, this agent has been linked to have several side effects such as cardiovascular, gastrointestinal, and kidney. These side effects represent the unmet needs in the safety of existing treatment of osteoarthritis. Such results can be caused by the overlapping functions of COX-1 and COX-2 in physiological and pathophysiological systems. The overlapping functions of COX-1 and COX-2 can be the source of these side effects. The extensive history of the use of curcuminoids and boswellia in pain relief coupled with recent findings shows that this phytochemical can play a direct role in several inflammatory processes and offers strong evidence that this product can slow down cartilage degradation and reduce pain in patients with knee osteoarthritis. Our study indicated that by reducing pain and improving function, while lowering the risk of side effects, curcuminoid formulations might become a useful addition to osteoarthritis patients for pharmacological therapeutic interventions. However, further research is needed with high-quality and large-scale RCT research probably to investigates the synergistic effects of these products with other osteoarthritis treatments.