Cochrane Handbook For Systematic Reviews Research Articles

The Diagnostic Accuracy of a Fecal Immunochemical Test in Detecting Colorectal Cancer and Advanced Precancerous Colorectal Neoplasia in Patients with Iron Deficiency: A Protocol for Systematic Review and Meta-Analysis.

Background. Iron deficiency (ID) is a common micronutrient deficiency and the leading cause of anemia worldwide. ID can be caused by chronic occult blood loss from colorectal neoplasia including colorectal cancer (CRC) and advanced precancerous colorectal lesions. Current guidelines recommend colonoscopy in both men and postmenopausal women presenting with ID anemia (IDA). However, there is controversy on the investigation of patients presenting with a lower risk of CRC including younger women with ID and those with nonanemic ID (NAID). There is a need for a triaging tool to identify which ID patients may benefit from colonoscopy. The fecal immunochemical test (FIT) is sensitive for CRC screening in an asymptomatic population, but its role in ID patients is unclear. The aim of this study is to conduct a systematic review to determine the diagnostic accuracy of FIT for detecting CRC and advanced precancerous neoplasia in individuals presenting with ID with or without anemia. Methods and Analysis. This protocol conforms with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols and Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy. A comprehensive search of the MEDLINE, Embase, and Web of Science databases will be undertaken for studies published after 2010 which involve patients with ID, who completed a FIT in the 6 months prior to colonoscopy, with FIT sensitivity and specificity calculated against the reference standard colonoscopy. The search will be limited to studies conducted after 2010 to reduce variability in colonoscopy quality. Risk of bias assessment will be conducted using the Quality Assessment of Diagnostic Accuracy Studies version 2. FIT sensitivity and specificity will be the primary measure of diagnostic accuracy, and data will be analysed using a random effects meta-analysis. Discussion. This review and meta-analysis will be the first to systematically explore the value of the FIT as a triaging tool for patients with ID. This trial is registered with CRD42022367162.

Acupuncture combined with pelvic floor rehabilitation training for postpartum stress urinary incontinence: protocol for a systematic review and meta-analysis.

The purpose of this study is to systematically evaluate the efficacy and safety of acupuncture combined with pelvic floor rehabilitation training in the treatment of postpartum stress urinary incontinence, and to promote the further promotion and application of acupuncture in the field of rehabilitation. Randomized controlled trials (RCTs) of acupuncture combined with pelvic floor rehabilitation in the treatment of postpartum stress urinary incontinence will be searched in PubMed, Web of Science (WOS), Cochrane Library, EMBASE, China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), Wanfang (WF), and VIP databases. The clinical trial Registry (ClinicalTrials.gov and Chinese clinical trial Registry) will also be searched. The search period is limited to July 1, 2023, and the language limit of this systematic review is Chinese and English. The primary outcome is clinical effective rate. International Consultation on Incontinence Questionnaire-Short Form (ICI-Q-SF), 1-h pad test, pelvic floor muscle potential value, incidence of adverse events are secondary outcomes. A meta-analysis will be performed using RevMan 5.4 statistical software. If feasible, subgroup analysis and sensitivity analysis will be performed to address potential causes of inconsistency and heterogeneity. The risk of bias will be assessed using the approach recommended by Cochrane Handbook for Systematic Reviews of Interventions, and the quality of evidence will be assessed using GRADE. This Protocol has been developed in accordance with the guideline of Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) 2015. Acupuncture combined with pelvic floor rehabilitation training can effectively promote the rehabilitation of postpartum stress urinary incontinence patients, and provide a reference for the clinical application of integrated Chinese and Western medicine treatment in the field of rehabilitation. PROSPERO CRD42023455801.

Effects of Peripherally inserted Central Catheter (PICC) materials and designs on reduction of PICC-related complications: A systematic review and meta-analysis.

Studies showed that integrating coating or valve into Peripherally Inserted Central(PICC) can prevent related complications. However, data regarding efficiency were controversial. Therefore, a systematic review was needed to analyse the effect of PICC materials and designs on reduction of PICC-related complications. We searched PubMed, Cochrane library, EMbase, grey literature and referent literature from inception to 5 August 2022. Randomized controlled trials (RCTs) and case-control study were included. Two authors extracted data independently, using a predesigned Excel form, and assessed the quality of included RCTs according to the Cochrane Handbook for Systematic Reviews (V5.1.0), case-control study was assessed by the Newcastle-Ottawa Scale. Data were analysed using Review Manager (v5.3.0). A total of 10 RCTs and one case-control study were included. Meta-analysis results showed that PICC designs reduce the incidence of obstruction, and at the critical value of PICC-associated bloodstream infection, but may have no effects on other complications. Based on the literature reviewed, we can only say PICC new materials did not reflect significant reduction on complications, what's more, the result needs more multicentre, large RCTs to support. We suggested clinicians combine descriptive research and cost-effect analysis to select appropriate PICC materials and designs for patients.

Diode laser targeting red-complex bacteria in periodontitis: a systematic review.

This systematic review examines the effectiveness of diode laser irradiation in reducing the levels of red complex bacteria as well as periodontal parameters of pocket depth and clinical attachment level. We conducted electronic searches across databases such as Scopus, Embase, Medline, and Web of Science databases in July 2022. Randomized controlled trials that evaluated the reduction of red-complex bacteria in patients with periodontitis using diode lasers were included. The primary focus was the reduction in the microbial count of red complex bacteria, whereas probing depth and attachment level were considered secondary outcomes. Articles in languages other than English were excluded. Study quality was assessed based on the Cochrane Handbook for Systematic Reviews of Interventions and the ROB2 tool. After searching the databases, eight independent studies were included, with a sample size of 210 subjects. The average age group of the study population was 30-60 years, and there was a lack of consensus on the antimicrobial effect of diode lasers. Out of the eight studies, four studies reported no significant difference in the levels of red complex bacteria before and after laser application. Three studies reported significantly lower levels of red complex bacteria in the intergroup comparison. One study reported that laser had no significant effect on intergroup bacterial levels. The combination of diode laser irradiation with scaling reduced the count of red complex bacteria and improved the clinical parameters, although not significantly. Based on the limited evidence available, the adjunctive use of diode laser for scaling and root planning may provide some additional benefit in terms of reduction of red complex bacterial count and clinical parameters. Further well-designed trials and the use of objective measures are necessary before outlining universal guidelines for best practice. The adjunctive use of diode laser in non-surgical periodontal therapy may provide a reduction in the red complex microbial count and improvement in clinical parameters, decreasing the need for periodontal surgery.

Nonpharmacological interventions and outcomes in the management of complications of human T-cell lymphotropic virus type 1-related myelopathy/tropical spastic paraparesis: A systematic review.

Human T-cell lymph tropic virus type 1 (HTLV-I)-related myelopathy/tropical spastic paraparesis (TSP) is a progressive inflammatory process affecting the spinal cord that occurs as a result of HTLV 1. The use of nonpharmacological approaches has always been one of the treatment strategies in these patients, but disagreement about these interventions and their results has led to their limited use. Therefore, this study aimed to identify nonpharmacological interventions and their consequences in these patients. We followed the Cochrane Handbook for systematic reviews of interventions. The present report is organized according to the preferred reporting items for systematic reviews and meta-analyses. This study was conducted at PubMed, Cochrane Library, Web of Science, and Scopus, among all published studies by December 30, 2021. Keywords were: HTLV-1, Human T-lymph tropic virus 1, HTLV-I-associated myelopathy, HAM/TSP, tropical spastic paraparesis, nonpharmacological intervention, nonpharmacological treatment, massage, physiotherapy, acupuncture, acupressure, and exercise. The quality of the studies was assessed using JADAD. Of 288 articles, 11 were eligible for data extraction published between 2014 and 2021. 90/9% of studies were randomized clinical trials. 81/8% of articles were of high quality. The total sample size was 253 people, of which 137 (54/15%) were women. Approaches such as exercise and motion therapy, electrotherapy, behavioral therapy, and virtual reality can be used for these patients. With these interventions, results such as improved mobility and balance, physical condition, pain, quality of life, muscle spasticity, maximum inspiratory pressure, and urinary symptoms can be achieved. The most common physical therapy method used in studies was active and passive body movements, which are associated with positive results for patients. Due to the small sample size in this group of studies, it is necessary to conduct more clinical trials for more accurate conclusions. Furthermore, due to the limited number of studies that have used electrical stimulation or combined intervention packages, it is not possible to say with certainty what effect these methods have on patients. It is necessary to conduct more clinical trials.

Individual and community-level risk factors for maternal morbidity and mortality among Native American women in the USA: protocol for systematic review

IntroductionIncidents of maternal morbidity and mortality (MMM) continue to rise in the USA. Significant racial and ethnic health inequities exist, with Native American (NA) women being three to four times...

Effectiveness of nutrition counseling for pregnant women in low- and middle-income countries to improve maternal and infant behavioral, nutritional, and health outcomes: A systematic review.

Nutritional counseling, which includes two-way interactive education, has been hypothesized to improve the health and nutritional status of pregnant women, but little is known about the impact such practice of care might have on maternal and infant health and behavioral outcomes of pregnant women living in low income, low-middle income, and upper-middle-income countries (LMIC)s. We conducted a systematic review to appraise the effectiveness and impact on health equity of two-way nutritional counseling practices in LMICs on maternal and infant behavioral, nutritional, and health outcomes. We conducted electronic searches for relevant studies on Medline, Embase, CINAHL, PsychInfo, and the Cochrane CENTRAL for randomized and non-randomized trials on the effectiveness of two-way interactive nutritional counseling among pregnant women from the date of database inception up to June 22, 2021. In addition, we searched references of included studies in systematic reviews, gray literature resources, and unpublished studies or reports that satisfied our eligibility criteria using a focused Google search. We included randomized and non-randomized controlled studies (NRS), controlled before and after, and interrupted time series that assessed the effectiveness of two-way interactive nutrition counseling targeting pregnant women in LMICs. Data extraction and risk of bias were conducted in duplicate. The risk of bias (ROB) for randomized trials (RCT) was assessed according to the Cochrane Handbook of Systematic Reviews, and ROB for NRS was assessed using the Newcastle-Ottawa scale (NOS). RCT and NRS were meta-analyzed separately. Our search identified 6418 records and 52 studies met our inclusion criteria, but only 28 were used in the quantitative analysis. Twenty-eight studies were conducted in Asia, the most in Iran. Eight studies were conducted in Africa. Two-way interactive nutritional counseling during pregnancy may improve dietary caloric intake (mean difference [MD]: 81.65 calories, 95% confidence interval [CI], 15.37-147.93, three RCTs; I 2 = 42%; moderate certainty of evidence using GRADE assessment), may reduce hemorrhage (relative risk [RR]: 0.63; 95% CI, 0.25-1.54, two RCTs; I 2 = 40%; very low certainty of evidence using GRADE assessment), may improve protein (MD: 10.44 g, 95% CI, 1.83-19.05, two RCTs; I 2 = 95%; high certainty of evidence using GRADE assessment), fat intake (MD: 3.42 g, 95% CI, -0.20 to 7.04, two RCTs; I 2 = 0%; high certainty of evidence using GRADE assessment), and may improve gestational weight gain within recommendations (RR: 1.84; 95% CI, 1.10-3.09, three RCTs; I 2 = 69%). Nutrition counseling probably leads to the initiation of breastfeeding immediately after birth (RR: 1.72; 95% CI, 1.42-2.09, one RCT). There was little to no effect on reducing anemia (RR: 0.77; 95% CI, 0.50-1.20, three RCTs; I 2 = 67%; very low certainty of evidence using GRADE assessment) risk of stillbirths (RR: 0.81; 95% CI, 0.52-1.27, three RCTs; I 2 = 0%; moderate certainty of evidence using GRADE assessment) and risk of cesarean section delivery (RR: 0.96; 95% CI, 0.76-1.20, four RCTs; I 2 = 36%; moderate certainty of evidence using GRADE assessment). Our review highlights improvements in maternal behavioral and health outcomes through interactive nutrition counseling during pregnancy. However, we are uncertain about the effects of nutrition counseling due to the low certainty of evidence and a low number of studies for some key outcomes. Moreover, the effects on health equity remain unknown. More methodologically rigorous trials that focus on a precise selection of outcomes driven by the theory of change of nutrition counseling to improve maternal and infant behavioral and health outcomes and consider equity are required.

Imaging Evaluation of Platelet-Rich Fibrin in Post-Exodontic Bone Regeneration: A Systematic Review.

Tooth extraction is the most common procedure in dental practice. However, in the long term, it may cause alveolar ridge atrophy. This systematic review aimed to evaluate the role of platelet-rich fibrin (PRF) in post-exodontic alveolar ridge preservation in terms of its effectiveness in the regeneration of bone tissue as assessed by imaging and its efficacy compared to physiological bone healing. The study is presented in accordance with the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. This systematic review was conducted using electronic databases such as PubMed, Scopus, Web of Science, and Science Direct. The gray literature search was conducted in the New York Academy of Medicine Grey Literature Report. All the studies in this systematic review were randomized controlled trials (RCTs). The risk of bias was performed according to the Cochrane Handbook for Systematic Reviews of Interventions 6.2 (RevMan 6.2). Considering the inclusion and exclusion criteria, we included 17 randomized clinical trials published up to 2022 investigating the efficacy of PRF in post-exodontic bone regeneration. Based on the results of clinical studies, it can be stated that despite not being statistically significant, PRF promotes neoformation and prevents bone loss between three and four months post-extraction.

Key Prognostic Factors in Patients with Relapsed/Refractory Follicular Lymphoma: An Evidence Based Systematic Literature and Medical Review

Introduction: A multi-center multi-country retrospective cohort study (FLORA [NCT05338879]), using real-world data (RWD) from electronic medical records (EMRs) and research databases, for patients with relapsed/refractory follicular lymphoma grade 1-3a (r/r FL) treated with standard of care is being conducted to contextualize treatment outcomes in a single-arm trial. A systematic literature review (SLR) was carried out to identify baseline prognostic factors that will be evaluated for imbalances between cohorts in the single-arm trial and RWD study. This SLR was followed by an evidence-based clinical expert review and ranking of prognostic variables in order of importance for the FLORA study as described herein. Methods: The approach and methods of the SLR (International Prospective Register of Systematic Reviews [PROSPERO] CRD42022307561) were informed by guidelines set forth by the Cochrane Handbook for Systematic Reviews of Interventions (Higgins et. al. 2021) and PRISMA (Page et. al. BMJ 2021) and described previously (Hampp et. al. ISPOR 2023). Following the conduct of the SLR, the identified potential prognostic variables were evaluated by the FLORA study team to remove treatment-specific and outcome variables, determine their availability in the single-arm trial and FLORA RWD study, and develop a questionnaire. In the questionnaire, prognostic variables were grouped by type of variable - clinical, laboratory data, or treatment characteristic. Each prognostic variable was reviewed by an international panel consisting of 3 clinical experts in the field of lymphoma who categorized the prognostic impact on treatment response and survival on a 5-point scale ranging from “Very high importance” to “Not important”. The clinicians were asked to consider possible correlation among the variables, possible effect modifiers, specific variable definitions (e.g., chemoresistant), and whether there were any other prognostically important variables not captured in the questionnaire. For each variable the clinical experts categorized the availability within routine care on a 3-point scale ranging from “Readily available” to “Limited availability”. The results of the 3 expert completed questionnaires were reviewed and the top 10 highest ranking variables were determined by summing the clinicians' categorization of prognostic impact and considering variable availability in the event of a tie. Individual interviews with each clinical expert were held to clarify variables and definitions, discuss discrepant categorization, and rank the prognostic variables from 1-10. Following the 3 interviews, the ranking of each variable was summed across the 3 experts to determine the final ranking. Results: Across the 13 studies included, the SLR identified 28 prognostic factors, including patient demographics and clinical characteristics, disease and treatment characteristics, and laboratory data. Seven clinical outcomes with statistically significant associations were identified (most commonly, overall survival [OS], progression-free survival [PFS], and relapse/progression). No additional prognostic factors were identified by the clinical experts. The final ranked list of the 10 most important prognostic variables in descending order of importance includes: progression of disease within 2 years (POD24), chemo-immunorefractory/chemoresistant, refractory to last line of therapy (LoT), number of prior LoTs, serum lactate dehydrogenase (LDH), Eastern Cooperative Oncology Group (ECOG) performance status, Follicular Lymphoma International Prognostic Index (FLIPI), age at start of LoT, Ann Arbor disease stage, and refractory to rituximab. Conclusion: SLR-based identification of prognostic factors combined with expert clinical review provides an unbiased evaluation and ranking of the level of evidence to assist in selecting prognostic factors to collect for the FLORA real-world cohort study. The appropriate selection of prognostic factors is critical for valid outcome estimation. These factors will be used for the evaluation of balance with the single-arm trial and for adjustment in a propensity score model. With this approach, the prognostic factors are chosen a priori to enable balancing of baseline covariates prior to outcome estimation.

Efficacy and safety of the integration of traditional Chinese medicine and western medicine in the treatment of diabetes-associated cognitive decline: a systematic review and meta-analysis

Objective: In order to offer possible therapeutic treatment evidence for diabetes-associated cognitive decline (DACD), we thoroughly evaluated the effectiveness and safety of combining Traditional Chinese Medicine (TCM) and Western Medicine (WM) in the current study.Methods: The present study employed a comprehensive search strategy across multiple databases, namely, PubMed, EMBASE, Web of Science, the Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang Data, Chinese Scientific Journals Database (VIP), and Chinese Biomedical Literature Database (CBM), to identify relevant articles published until July 2023. Subsequently, a systematic review and meta-analysis of randomized controlled trials (RCTs) were conducted to assess the efficacy and safety of integrating TCM with WM for the treatment of DACD. The literature included in this study was assessed using the GRADE criteria and the Cochrane Handbook for Systematic Reviews of Interventions. Statistical analysis was conducted using RevMan 5.4 software.Results: A total of 20 RCTs involving 1,570 patients were ultimately included in this meta-analysis. The pooled results demonstrated that the integration of TCM and WM therapy significantly enhanced the overall effectiveness rate compared to WM therapy alone [OR = 4.94, 95% CI (3.56, 6.85), p < 0.00001]. Additionally, the combination therapy resulted in reductions in fasting blood glucose [MD = −0.30, 95% CI (−0.49, −0.10), p = 0.003], HbA1c [MD = −0.71, 95%CI (−1.03, −0.40), p < 0.00001], TNF-α levels [MD = −8.28, 95%CI (−13.12, −3.44), p = 0.0008], and TCM Syndrome Score [MD = −5.97, 95%CI (−9.06, −2.88), p = 0.0002]. Meanwhile, the combination therapy had a positive effect on MoCA Score [MD = 2.52, 95% CI (1.75, 3.30), p < 0.00001], and MMSE Score [MD = 2.31, 95% CI (1.33, 3.29), p < 0.00001]. In addition, the safety of the combination therapy was comparable to that of the WM alone [OR = 0.40, 95% CI (0.12, 1.31), p = 0.13].Conclusion: The integration of TCM and WM therapy outperformed WM alone in DACD treatment. Simultaneously, the combination therapy could improve the therapeutic effect on blood glucose, cognitive function, and inflammation to a certain extent with few adverse effects. However, given the constraints imposed by the quality limitations of the incorporated studies, as well as the potential presence of reporting bias, it is imperative that our findings be substantiated through rigorous, large-scale, randomized controlled trials of superior quality in the future.

Radiomics to Differentiate Malignant and Benign Breast Lesions: A Systematic Review and Diagnostic Test Accuracy Meta-Analysis.

Breast cancer is a prevalent global health concern, necessitating accurate diagnostic tools for effective management. Diagnostic imaging plays a pivotal role in breast cancer diagnosis, staging, treatment planning, and outcome evaluation. Radiomics is an emerging field of study in medical imaging that contains a broad set of computational methods to extract quantitative features from radiographic images. This can be utilized to guide diagnosis, treatment response, and prognosis in clinical settings. A systematic review was performed in concordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and the Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy. Quality was assessed using the radiomics quality score. Diagnostic sensitivity and specificity of radiomics analysis, with 95% confidence intervals (CIs), were included for meta-analysis. The area under the curve analysis was recorded. An extensive statistical analysis was performed following the Cochrane guidelines. Statistical significance was determined if p-values were less than 0.05. Statistical analyses were conducted using Review Manager (RevMan), Version 5.4.1. A total of 31 manuscripts involving 8,773 patients were included, with 17 contributing to the meta-analysis. The cohort comprised 56.2% malignant breast cancers and 43.8% benign breast lesions. MRI demonstrated a sensitivity of 0.91 (95% CI: 0.89-0.92) and a specificity of 0.84 (95% CI: 0.82-0.86) in differentiating between benign and malignant breast cancers. Mammography-based radiomic features predicted breast cancer subtype with a sensitivity of 0.79 (95% CI: 0.76-0.82) and a specificity of 0.81 (95% CI: 0.79-0.84). Ultrasound-based analysis yielded a sensitivity of 0.92 (95% CI: 0.90-0.94) and a specificity of 0.85 (95% CI: 0.83-0.88). Only one study reported the results of radiomic evaluation from CT, which had a sensitivity of 0.95 (95% CI: 0.88-0.99) and a specificity of 0.56 (95% CI: 0.45-0.67). Across different imaging modalities, radiomics exhibited robust diagnostic accuracy in differentiating benign and malignant breast lesions. The results underscore the potential of radiomic assessment as a minimally invasive alternative or adjunctive diagnostic tool for breast cancer. This is pioneering data that reports on a novel diagnostic approach that is understudied and underreported. However, due to study limitations, the complexity of this technology, and the need for future development, biopsy still remains the current gold standard method of determining breast cancer type.

Different antibiotic treatments for group A streptococcal pharyngitis.

Different antibiotic treatments for group A streptococcal pharyngitis.

Key Prognostic Factors in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma: An Evidence Based Systematic Literature and Medical Review

Introduction: A multi-center multi-country retrospective cohort study (ORCHID [NCT05338879]), using real-world data (RWD) from electronic medical records (EMRs) and research databases, for patients with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL) treated with standard of care is being conducted to contextualize treatment outcomes in a single-arm trial. A systematic literature review (SLR) was carried out to identify baseline prognostic factors that will be evaluated for imbalances between cohorts in the single-arm trial and RWD study. This SLR was followed by an evidence-based clinical expert review of prognostic variables and ranking in order of importance for the ORCHID study as described herein. Methods:The approach and methods of the SLR (International Prospective Register of Systematic Reviews [PROSPERO] CRD42022307557) were informed by guidelines set forth by the Cochrane Handbook for Systematic Reviews of Interventions (Higgins et. al. 2021) and PRISMA (Page et. al. BMJ 2021) and described previously (Hampp et. al. ISPOR 2023). Following the conduct of the SLR, the identified potential prognostic variables were evaluated by the ORCHID study team to remove treatment-specific and outcome variables, determine their availability in the single-arm trial and ORCHID RWD study, and develop a questionnaire. In the questionnaire, prognostic variables were grouped by type of variable - clinical, laboratory data, molecular characteristic, or treatment characteristic. Each prognostic variable was reviewed by an international panel consisting of 3 clinical experts in the field of lymphoma who categorized the prognostic impact on treatment response and survival on a 5-point scale ranging from “Very high importance” to “Not important”. The clinicians were asked to consider possible correlation among the variables, possible effect modifiers, specific variable definitions (e.g., early chemoimmunotherapy failure), and whether there were any other prognostically important variables not captured in the questionnaire. For each variable, the clinical experts categorized the availability within routine care on a 3-point scale ranging from “Readily available” to “Limited availability”. The results of the 3 expert completed questionnaires were reviewed and the top 10 highest ranking variables were determined by summing the clinicians' categorization of prognostic impact and considering variable availability in the event of a tie. Individual interviews with each clinical expert were held to clarify variables and definitions, discuss discrepant categorization, and rank the prognostic variables from 1-10. Following the 3 interviews, the ranking of each variable was summed across the 3 experts to determine the final ranking. Results: Across the 46 studies included, the SLR identified 36 prognostic factors, including patient demographics and clinical characteristics, disease and treatment characteristics, and laboratory data. Seven clinical outcomes with statistically significant associations were identified (most commonly, overall survival [OS], progression-free survival [PFS], and overall response rate [ORR]). No additional prognostic factors were identified by the clinical experts. The final ranked list of the 10 most important prognostic variables in descending order of importance includes: early chemoimmunotherapy failure, Eastern Cooperative Oncology Group (ECOG) performance status, refractory to last line of therapy (LoT), number of prior LoTs, double or triple-hit lymphoma, age at start of LoT, Internal Prognostic Index (IPI) risk classification, Ann Arbor disease stage, serum lactate dehydrogenase (LDH), and Deauville score. Conclusion:SLR-based identification of prognostic factors combined with expert clinical review provides an unbiased evaluation and ranking of the level of evidence to assist in selecting prognostic factors to collect for the ORCHID real-world cohort study. The appropriate selection of prognostic factors is critical for valid outcome estimation. These factors will be used for the evaluation of balance with the single-arm trial and for adjustment in a propensity score model. With this approach, the prognostic factors are chosen a priori to enable balancing of baseline covariates prior to outcome estimation.

Comparison of drug-coated balloon angioplasty versus standard medical therapy on recurrent stroke and mortality rates among patients with symptomatic intracranial atherosclerotic stenosis: protocol for a systematic review and meta-analysis

IntroductionStroke remains the second leading cause of death worldwide, a common cause of which is intracranial atherosclerotic stenosis (ICAS). Medical treatment is recommended as first-line therapy for treating ICAS, but...

Internal structure validity and internal consistency reliability of the Minnesota Living with Heart Failure Questionnaire: a systematic review protocol

IntroductionThe Minnesota Living with Heart Failure Questionnaire (MLHFQ) is one of the most used tools to measure health-related quality of life in heart failure. Despite extensive use in research, evidence...

The effect of disease modifying therapies on fatigue in multiple sclerosis.

Fatigue is one of the most common and debilitating symptoms in people with multiple sclerosis (PwMS). Disease-modifying therapies (DMTs) are currently the gold standard in the treatment of MS and their effectiveness has been assessed through randomized clinical trials (RCTs). However, there is limited evidence on the impact of DMTs on fatigue in (PwMS). We conducted a systematic review to 1) understand whether fatigue is included as an outcome in MS trials of DMTs; 2) determine the effects on fatigue of treating MS with DMTs and 3) assess the quality of MS trials including fatigue as an outcome. Two independent researchers systematically searched MEDLINE, EMBASE and ClinicalTrials.gov from 1993 to January 2023 for RCTs that measured fatigue as an outcome. Adherence to reporting standards was assessed with the Consolidated Standards of Reporting Trials (CONSORT)-Patient-Reported Outcomes (PRO), while the risk of bias (RoB) was assessed with the RoB 2 tool by the Cochrane Handbook for Systematic Reviews of Interventions. The systematic review protocol was registered in PROSPERO (CRD42022383321). The search strategy identified 130 RCTs of DMTs of which 7 (5%) assessed fatigue as an outcome. Of the 7 trials, only two presented statistically significant results. In addition, the reporting of fatigue among RCTs was suboptimal with a mean adherence to the CONSORT-PRO Statement of 36% across all trials. Of the 7 trials included, four were assessed as 'high' RoB.. Fatigue has a major impact on PwMS yet there is limited trial-based evidence on the impact of DMTs on fatigue. Assessment of fatigue as an outcome is underrepresented in trials of DMTs and the reporting of PRO trial data is suboptimal. Thus, it is imperative that MS researchers conduct RCTs that include fatigue as an outcome, to support clinicians and people with MS (PwMS) to consider the impact of the different DMTs on fatigue.

A Network Meta-analysis of the Efficacy and Safety of Targeted Drug Combinations in the Treatment of Pulmonary Arterial Hypertension

Objective: This network meta-analysis aims to compare the efficacy and safety of different targeted drug combination treatment for pulmonary arterial hypertension (PAH). Methods: Searches were conducted in Cochrane, PubMed, EMBASE, China National Knowledge Infrastructure, China Biomedical Literature Database, Wanfang Database, and VIP Chinese Science and Technology Journal Data to identify both published and unpublished randomized controlled trials from inception until January 1, 2022. The risk of bias in the included studies was assessed in accordance with the Cochrane Handbook for Systematic Reviews of Interventions. A network meta-analysis was performed using Stata 16.0 software. The efficacy and safety of different targeted drugs combined treatment for PAH were evaluated based on forest plot, funnel plot, and surface under the cumulative ranking. Results: A total of 29 randomized controlled trails with 4,448 patients treated with 10 different types of targeted drug combinations were included in this study. The results of the surface under the cumulative ranking showed that the combination regimen was the best clinical option to improve symptoms and delay progression in patients with pulmonary artery hypertension compared with monotherapy. Sildenafil in combination with ambrisentan significantly improved the 6-minute walk distance and reduced N-terminal pro-brain natriuretic peptide levels. Bosentan in combination with sildenafil significantly reduced mean pulmonary artery pressure, whereas bosentan in combination with epoprostenol was more effective than other combinations in reducing pulmonary vascular resistance. Bosentan in combination with tadalafil significantly improved the Borg dyspnea score, and bosentan in combination with iloprost was the best combination for improving World Health Organization functional class/New York Heart Association functional class. In terms of safety, there was no significant reduction in the incidence of adverse events, hospitalizations, or all-cause mortality for combination therapy compared with monotherapy. Bosentan combined with sildenafil significantly reduced the risk of serious adverse events, but the risk of discontinuation due to an adverse event was higher than monotherapy. Sildenafil combined with epoprostenol reduced the risk of clinical worsening in patients with PAH. Conclusion: Compared with monotherapy, targeted drug combinations for PAH significantly improves exercise tolerance, pulmonary hemodynamic parameters, and reduces the risk of serious adverse events and clinical worsening in patients. Bosentan in combination with sildenafil and bosentan in combination with iloprost are combinations of targeted agents with significant efficacy and better safety profile than monotherapy for the treatment of PAH. Sildenafil in combination with epoprostenol has a low risk of clinical worsening in PAH.

Contralateral hamstring autografts do not provide benefit compared to ipsilateral hamstring autografts in primary or revision anterior cruciate ligament reconstruction: a systematic review.

To evaluate the clinical outcomes of primary or revision ACL reconstruction (ACLR) after contralateral hamstring autografts versus ipsilateral hamstring autograft harvest. Three databases (MEDLINE, PubMed and EMBASE) were searched from inception to April 27th, 2023 for studies investigating contralateral hamstring autografts in primary or revision ACLR. The authors adhered to the PRISMA and R-AMSTAR guidelines as well as the Cochrane Handbook for Systematic Reviews of Interventions. Data on demographics, strength measures, patient-reported outcome measures (PROMs), and rates of positive Lachman test, positive pivot-shift test and graft rupture were extracted. PROMs included Lysholm, International Knee Documentation Committee (IKDC) and Tegner scores. Nine studies comprising 371 patients were included in this review. In primary ACLR, there were no significant differences between contralateral and ipsilateral groups in isokinetic hamstring torque in the non-ACLR limb or isokinetic quadriceps torque in both limbs when tested at 60, 90, 120 or 180 degrees/second. Isokinetic hamstring torque in the non-ACLR limb was significantly weaker in the contralateral group at six months for primary ACLR; however, these deficits did not persist. There were no significant differences in postoperative median Tegner scores and Lysholm scores between contralateral and ipsilateral groups in primary ACLR. There were no significant differences in postoperative median Tegner, mean Lysholm and IKDC scores between groups in revision ACLR. There were no significant differences in positive Lachman, positive pivot-shift and rupture rates in primary ACLR between groups. Rates of positive Lachman and pivot-shift were slightly higher in the contralateral than ipsilateral group for revision ACLR. Contralateral hamstring autografts results in comparable muscle strength to ipsilateral hamstring autografts, with the exception of weaker hamstring strengths in the early postoperative period. Patient-reported outcome measures were similar between the two groups across both primary and revision ACLR, with rates of instability and failure being similar between groups for primary ACLR. Contralateral hamstring grafts do not provide additional benefit when compared to ipsilateral options for either primary or revision ACLR, and should be used only in select circumstances including insufficient ipsilateral hamstring grafts or situations where quadriceps or patella autografts are not optimal. Level IV.

White spot lesions in clear aligner therapy as compared with multi-bracket system: A Systematic Review

To evaluate incidence of white spot lesions in clear aligner treatment compared with fixed appliance therapy.Electronic databases (PubMed, Cochrane Collaboration Oral Health group database of clinical trials, Web of Science, Science Direct, Scopus) and manual search of gray literature were conducted up to September 2021. Both randomized and non-randomized controlled studies were considered for review purposes. Study selection, data extraction, quality assessment (RoB 2.0 and ROBINS-I) was performed according to the Cochrane Handbook for Systematic Reviews of Intervention. Due to the presence of high heterogeneity only qualitative analysis has been done.Out of 479 retrieved literature, 3 studies fulfilled the eligibility criteria and were included in the analysis. Studies were evaluated at low to high risk of bias. On qualitative analysis, a total of 160 new white spot lesions were developed in the clear aligner group and 362 new lesions were found in the fixed orthodontic group (P <0.001). In addition, the surface area of white spot lesion in the clear aligner group was more than the fixed appliance group but the deepest lesion was still found in the fixed appliance group. Incidence and severity of white spot lesion was found more in the fixed appliance group as compared to the clear aligner group. However, more low risk of bias studies with proper methodological quality is required to reinforce the conclusive evidence.

Comparison of ointment-based agents after excisional procedures for hemorrhoidal disease: a network meta-analysis of randomized controlled trials.

Efficient postoperative pain control is important after hemorrhoidal surgery. Although several locally applied medications have been used, current evidence regarding the optimal strategy is still conflicting. This network meta-analysis assessed analgesic efficacy and safety of the various topical medications in patients submitted to excisional procedures for hemorrhoids. The present study followed the Cochrane Handbook for Systematic Reviews of Interventions and the PRISMA guidelines. The last systematic literature screening was performed at 15 June 2023. Comparisons were based on a random effects multivariate network meta-analysis under a Bayesian framework. Overall, 26 RCTs and 2132 patients were included. Regarding postoperative pain, EMLA cream (surface under the cumulative ranking curve (SUCRA) 80.3%) had the highest ranking at 12-h endpoint, while aloe vera cream (SUCRA 82.36%) scored first at 24 h. Metronidazole ointments had the highest scores at 7 and 14 days postoperatively. Aloe vera had the best analgesic profile (24-h SUCRA 84.8% and 48-h SUCRA 80.6%) during defecation. Lidocaine (SUCRA 87.9%) displayed the best performance regarding overall morbidity rates. Due to the inconclusive results and several study limitations, further RCTs are required.