Population, Intervention, Comparison, Outcome Research Articles

Comparison of the Effect of Glycemic Control on the Incidence of Fetal Macrosomia and Large for Gestational Age in Gestational Diabetes Mellitus Patients; A Systematic Review

Background: Gestational diabetes mellitus (GDM) can be managed with blood glucose control management, which includes a healthy lifestyle, insulin therapy, and oral anti-diabetic drug (OAD) medications when needed. Sub-optimally or poorly managed GD Mmay lead to arisk of complications, one of which is an abnormal growth in the fetus. This study aimed to compare the effect of blood glucose control management on the incidence of fetal macrosomia and large for gestational age (LGA) births in patients with GDM. Methods: This systematic review study obtained data from formerly published studies from the Science Direct database. The article search method used the characteristics of PICO (Population, Intervention, Comparison, Outcome) and compiled using the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) method. Conclusion: The use of medical nutrition therapy (MNT) and exercise in the therapeutic regimen, as well as routine monitoring of glycemic levels are very important to control the patient’s glycemic level. The use of metformin can increase the success of therapy due to reduced levels of LGA and macrosomia in GDM patients

Systematic Reviews in Medical Education.

Systematic Reviews in Medical Education.

Does the use of alcohol mouthwash increase the risk of developing oral cancer?

Design Systematic review.Case selection This study had a focused research format in terms of PICO (Population, Intervention, Comparison, Outcomes). There were no age, gender or medical conditions which restricted or excluded patients from the inclusion criteria. The intervention was the use of alcohol-based mouthwashes in comparison to the control group where no mouthwash was used. A literature search was carried out utilising three electronic databases including PubMed, Scopus and Cochrane Library. The papers included for analysis within this review were all published from 2006 onwards and animal studies, case series and case reports were excluded.Data analysis The qualitative analysis included 43,499 participants from eight papers which included two meta-analyses, one clinical trial, three case-control studies and two cohort studies, all of which fulfilled the inclusion criteria. Data were analysed by two independent reviewers who initially screened the articles and removed duplications before a second round of in-depth evaluation was conducted. A third reviewer was also included to act impartially to resolve any disagreements and reduce bias within the study. Risk of bias within studies was assessed utilising the Newcastle-Ottawa Scale (NOS) which provided a uniform approach between the reviewers. A score of 6 or greater was associated with a low level of bias.Results The primary outcome parameter measured was acetaldehyde levels in saliva and the secondary outcome factor was the risk of developing an oral cancer. The results from this review concluded that the relationship between the use of alcohol mouthwash and cancer risk is complex and influenced by multiple variables. Factors which may influence the risk of developing an oral cancer from the use of alcohol mouthwash include increased frequency of rinsing (more than three times daily), total duration of mouthwash use (>35 years), poor oral hygiene and presence of other risk factors (for example, smoking and alcohol intake).Conclusions The use of alcohol-containing mouthwashes alone (when no other risk factors are present) does not increase the risk of developing an oral cancer or lead to increased salivary acetaldehyde. However, where other risk factors for oral cancer are present, the use of an alcohol-based mouthwash may further increase this risk.

Treatment of Provoked Vulvodynia: A Systematic Review

BackgroundTreatment recommendations for provoked vulvodynia (PVD) are based on clinical experiences and there is a need for systematically summarizing the controlled trials in this field. AimTo provide an overview of randomized controlled trials and non-randomized studies of intervention for PVD, and to assess the certainty of the scientific evidence, in order to advance treatment guidelines. Data SourcesThe search was conducted in CINAHL (EBSCO), Cochrane Library, Embase (Embase.com), Ovid MEDLINE, PsycINFO (EBSCO) and Scopus. Databases were searched from January 1, 1990 to January 29, 2021. Study Eligibility CriteriaPopulation: Premenopausal women with PVD. Interventions: Pharmacological, surgical, psychosocial and physiotherapy, either alone or as combined/team-based interventions. Control: No treatment, waiting-list, placebo or other defined treatment. Outcomes: Pain during intercourse, pain upon pressure or touch of the vaginal opening, sexual function/satisfaction, quality of life, psychological distress, adverse events and complications. Study design: Randomized controlled trials and non-randomized studies of interventions with a control group. Study Appraisal and Synthesis Methods2 reviewers independently screened citations for eligibility and assessed relevant studies for risk of bias using established tools. The results from each intervention were summarized. Studies were synthesized using a narrative approach, as meta-analyses were not considered appropriate. For each outcome, we assessed the certainty of evidence using grading of recommendations assessment, development, and evaluation (GRADE). ResultsMost results of the evaluated studies in this systematic review were found to have very low certainty of evidence, which means that we are unable to draw any conclusions about effects of the interventions. Multimodal physiotherapy compared with lidocaine treatment was the only intervention with some evidential support (low certainty of evidence for significant treatment effects favoring physiotherapy). It was not possible to perform meta-analyses due to a heterogeneity in interventions and comparisons. In addition, there was a heterogeneity in outcome measures, which underlines the need to establish joint core outcome sets. Clinical ImplicationsOur result underscores the need of stringent trials and defined core outcome sets for PVD. Strength and LimitationsStandard procedures for systematic reviews and the Population Intervention Comparison Outcome model for clinical questions were used. The strict eligibility criteria resulted in limited number of studies which might have resulted in a loss of important information. ConclusionThis systematic review underlines the need for more methodologically stringent trials on interventions for PVD, particularly for multimodal treatments approaches. For future research, there is a demand for joint core outcome sets.Bohm-Starke N, Ramsay KW, Lytsy P, et al. Treatment of Provoked Vulvodynia: A Systematic Review. J Sex Med 2022;19:789–808.

Updates from Important Trials in Cardiology of 2021 (January – June)

Critical appraisal of scientific publications is an important skill that must be acquired by the contemporary cardiologists. The preliminary step to a good critical appraisal is a sound understanding of the important aspects of a trial. In this issue of the Ibrahim Cardiac Medical Journal’s “Journal Scan”, we are first providing a brief summary of late-breaking randomised controlled trials published and presented at American College of Cardiology (ACC) Scientific Sessions 2021, and EuroPCR 2021, both of which were held virtually. We look at the important points to be derived from both potentially practice-changing trials, as well as key neutral trials of relevance in the above-mentioned meetings. In keeping with a critical appraisal format, each trial is introduced with its background and aims, PICO (Population, Intervention, Comparator, Outcomes) Criteria, main results and concluding remarks. Ibrahim Card Med J 2021; 11 (1): 86-95

TERAPI SPIRITUAL TERHADAP KECEMASAN DAN DEPRESI PADA PASIEN HEMODIALISIS : LITERATUR REVIEW

In the end-stage renal disease of CKD, the patients should be hemodialysis to stabilize the state of the kidney function. Increased psychological problems such as anxiety and depression resulting from CKD complications and the consequences of hemodialysis programs performed on patients. It is important for nurses to provide psychological support to patients. The application of complementary therapies such as spiritual therapy is essential. The purpose of this study was to explore various forms of spiritual therapy in hemodialysis for anxiety and depression. This study used electronic database were identified from MEDLINE, CINAHL, Proquest, and GARUDA. The criteria of the paper in this study are : articles published at 2012 – 2020, full text, the article using English or Bahasa Indonesia, and the method of study using experimental study. We extracted 6 intervention studies and critical analyzes used PICO (Population, Intervention, Comparator, Outcome) method. After applying spiritual therapy, several studies resulted in average scores of anxiety and depression that decreased in the intervention group, including Self Paced Therapy, Prayer, Dhikr, Murotal Holy Quran and Spiritual Counseling. In addition, this therapy also has a positive impact on some aspects of the patient's life include the physical and social relationships. Based on the analysis of the results some studies on CKD patients with hemodialysis therapy for anxiety and depression experienced the results obtained that spiritual therapy like include self-paced, prayer and dhikr therapy, and spiritual counselling can decrease anxiety and depression.

ESCMID COVID-19 guidelines: diagnostic testing for SARS-CoV-2

ScopeThe objective of these guidelines is to identify the most appropriate diagnostic test and/or diagnostic approach for SARS-CoV-2. The recommendations are intended to provide guidance to clinicians, clinical microbiologists, other health care personnel, and decision makers. MethodsAn ESCMID COVID-19 guidelines task force was established by the ESCMID Executive Committee. A small group was established, half appointed by the chair and the remaining selected with an open call. Each panel met virtually once a week. For all decisions, a simple majority vote was used. A list of clinical questions using the PICO (population, intervention, comparison, outcome) format was developed at the beginning of the process. For each PICO, two panel members performed a literature search focusing on systematic reviews, with a third panellist involved in case of inconsistent results. Quality of evidence assessment was based on the GRADE-ADOLOPMENT (Grading of Recommendations Assessment, Development and Evaluation - adoption, adaptation, and de novo development of recommendations) approach. RecommendationsA total of 43 PICO questions were selected that involve the following types of populations: (a) patients with signs and symptoms of COVID-19; (b) travellers, healthcare workers, and other individuals at risk for exposure to SARS-CoV-2; (c) asymptomatic individuals, and (d) close contacts of patients infected with SARS-CoV-2. The type of diagnostic test (commercial rapid nucleic acid amplification tests and rapid antigen detection), biomaterial, time since onset of symptoms/contact with an infectious case, age, disease severity, and risk of developing severe disease are also taken into consideration.

European Stroke Organisation - European Society for Minimally Invasive Neurological Therapy expedited recommendation on indication for intravenous thrombolysis before mechanical thrombectomy in patients with acute ischaemic stroke and anterior circulation large vessel occlusion.

Six randomized controlled clinical trials have assessed whether mechanical thrombectomy (MT) alone is non-inferior to intravenous thrombolysis (IVT) plus MT within 4.5 hours of symptom onset in patients with anterior circulation large vessel occlusion (LVO) ischaemic stroke and no contraindication to IVT. An expedited recommendation process was initiated by the European Stroke Organisation (ESO) and conducted with the European Society of Minimally Invasive Neurological Therapy (ESMINT) according to ESO standard operating procedure based on the GRADE system. We identified two relevant Population, Intervention, Comparator, Outcome (PICO) questions, performed systematic reviews and meta-analyses of the literature, assessed the quality of the available evidence and wrote evidence-based recommendations. Expert opinion was provided if insufficient evidence was available to provide recommendations based on the GRADE approach. For stroke patients with anterior circulation LVO directly admitted to a MT-capable centre ('mothership') within 4.5 hours of symptom onset and eligible for both treatments, we recommend IVT plus MT over MT alone (moderate evidence, strong recommendation). MT should not prevent the initiation of IVT, nor should IVT delay MT. In stroke patients with anterior circulation LVO admitted to a centre without MT facilities and eligible for IVT ≤4.5 hrs and MT, we recommend IVT followed by rapid transfer to a MT capable-centre ('drip-and-ship') in preference to omitting IVT (low evidence, strong recommendation). Expert consensus statements on ischaemic stroke on awakening from sleep are also provided. Patients with anterior circulation LVO stroke should receive IVT in addition to MT if they have no contraindications to either treatment.

ESCMID guidelines on testing for SARS-CoV-2 in asymptomatic individuals to prevent transmission in the health care setting

ScopeThis guideline addresses the indications for direct testing of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in asymptomatic individuals in health care facilities, with the aim to prevent SARS-CoV-2 transmissions in these settings. The benefit of testing asymptomatic individuals to create a safe environment for patients and health care workers must be weighed against potential unintended consequences, including delaying necessary treatments owing to false positive results and lower quality of care owing to strict isolation measures. MethodsA total of nine PICOs (population, intervention, comparison, outcome) on the topic of testing asymptomatic individuals was selected by the panel members. Subsequently, a literature search for existing guidelines and systematic reviews was performed on PubMed, Epistemonikos, and RecMap using relevant filters available in each database. Data on article/recommendation type, setting, target population, intervention, and quality of the evidence were extracted. Credibility of the systematic reviews was evaluated using the AMSTAR tool, and level of agreement with available recommendation was evaluated with the AGREE II score. Because the evidence available from systematic reviews was deemed insufficiently updated to formulate relevant recommendations, an additional search targeting relevant guidance documents from major public health institutions and original studies was performed. Provisional recommendations were discussed via web conferences until agreement was reached, and final recommendations were formulated according to the GRADE approach. RecommendationsRecommendations were formulated regarding systematic testing in asymptomatic individuals upon admission to a health care setting, during hospital stay, before elective procedures, and before scheduled nonsurgical procedures. Moreover, recommendations regarding testing of asymptomatic visitors, personal caregivers, and health care workers in health care facilities were presented. Recommendations also were given on contact tracing in asymptomatic patients or health care workers and the possibility of a negative screening test to shorten the quarantine period. Furthermore, if applicable, recommendations were specified to transmission rate and vaccination coverage.

Impact of Varicocele Repair on Semen Parameters in Infertile Men: A Systematic Review and Meta-Analysis.

Despite the significant role of varicocele in the pathogenesis of male infertility, the impact of varicocele repair (VR) on conventional semen parameters remains controversial. Only a few systematic reviews and meta-analyses (SRMAs) have evaluated the impact of VR on sperm concentration, total motility, and progressive motility, mostly using a before-after analytic approach. No SRMA to date has evaluated the change in conventional semen parameters after VR compared to untreated controls. This study aimed to evaluate the effect of VR on conventional semen parameters in infertile patients with clinical varicocele compared to untreated controls. A literature search was performed using Scopus, PubMed, Embase, and Cochrane databases following the Population Intervention Comparison Outcome (PICOS) model (Population: infertile patients with clinical varicocele; Intervention: VR [any technique]; Comparison: infertile patients with clinical varicocele that were untreated; Outcome: sperm concentration, sperm total count, progressive sperm motility, total sperm motility, sperm morphology, and semen volume; Study type: randomized controlled trials and observational studies). A total of 1,632 abstracts were initially assessed for eligibility. Sixteen studies were finally included with a total of 2,420 infertile men with clinical varicocele (1,424 patients treated with VR vs. 996 untreated controls). The analysis showed significantly improved post-operative semen parameters in patients compared to controls with regards to sperm concentration (standardized mean difference [SMD] 1.739; 95% CI 1.129 to 2.349; p<0.001; I²=97.6%), total sperm count (SMD 1.894; 95% CI 0.566 to 3.222; p<0.05; I²=97.8%), progressive sperm motility (SMD 3.301; 95% CI 2.164 to 4.437; p<0.01; I²=98.5%), total sperm motility (SMD 0.887; 95% CI 0.036 to 1.738; p=0.04; I²=97.3%) and normal sperm morphology (SMD 1.673; 95% CI 0.876 to 2.470; p<0.05; I²=98.5%). All the outcomes showed a high inter-study heterogeneity, but the sensitivity analysis showed that no study was sensitive enough to change these results. Publication bias was present only in the analysis of the sperm concentration and progressive motility. No significant difference was found for the semen volume (SMD 0.313; 95% CI -0.242 to 0.868; I²=89.7%). This study provides a high level of evidence in favor of a positive effect of VR to improve conventional semen parameters in infertile men with clinical varicocele. To the best of our knowledge, this is the first SRMA to compare changes in conventional semen parameters after VR with changes in parameters of a control group over the same period. This is in contrast to other SRMAs which have compared semen parameters before and after VR, without reference to a control group. Our findings strengthen the available evidence and have a potential to upgrade professional societies' practice recommendations favoring VR to improve conventional semen parameters in infertile men.

Dental Implants Survival After Nasal Floor Elevation: A Systematic Review.

The aim of this work is to assess the clinical outcomes of implants placed after a nasal floor elevation procedure. A systematic review was conducted using 4 electronic databases: MEDLINE (PubMed), Cochrane Library, Directory of Open Access Journals, and Scopus, following the PRISMA (Preferred Reporting Items for Systematic Reviews) statement recommendations to answer the PICO (Population, Intervention, Comparison, Outcome) question: "In patients undergoing dental implant placement in the maxillary anterior region (P), Do implants placed after nasal floor elevation (I) have a different survival (O) from those implants placed without grafting procedures (C)? The study was pre-registered in PROSPERO (CRD42021229479). Included article quality was assessed using the "NIH quality assessment tool", "The Newcastle-Ottawa scale," and "JBI critical appraisal tools for case reports." Twelve articles were finally selected, including 151 patients and 460 implants. The weighted mean follow-up was 32.2 months, and the weighted survival rate after this period was 97.64% (range: 89.2%-100%). No statistical differences could be inferred between the treatments performed in 1- or 2-stage, following a lateral approach or a transcrestal approach or using different grafting materials. A great heterogeneity was found in study design and methodological aspects. For this reason, a quantitative analysis followed by meta-analysis was not possible. Within the limitations of this study, implants placed after a nasal floor elevation present a good survival and a low range of complications. In absence of randomized studies, the level of evidence was low, attending the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) system and based on the study quality level, the strength of evidence attending the SORT (Strength Of Recommendation Taxonomy) was B.

Use of digital technologies in the nutritional management of catabolism-prone chronic diseases: A rapid review

Diet and nutrition applications (apps) have become more readily accessible as smartphone ownership increases. These apps have the potential to improve nutritional outcomes, but it remains unclear whether they are effective in patients with catabolism-prone conditions and specialized nutritional needs. The primary aim of this rapid review was to determine if delivery of a nutrition intervention via an app was more effective than standard care in improving nutritional outcomes in patients with a selected set of catabolism-prone chronic diseases. Secondary aims included summarizing intervention components and reviewing adherence and acceptance. The research question was developed using the Population, Intervention, Comparison, Outcomes (PICO) framework. Comprehensive literature searches were conducted across three databases. Screening, study selection, extraction, and risk of bias (RoB) assessment were conducted for the included randomized controlled trials (RCTs). 15 articles were included, including 5 RCTs; 3/5 RCTs were judged to be at high RoB. The study aims, measured outcomes, and intervention components were diverse. Adherence and acceptance to the app interventions were encouraging. Due to the heterogeneity of study design, nutrition interventions, outcomes, and reporting across studies, we were unable to aggregate data regarding the impact on nutritional outcomes. Reassuringly though, the available evidence suggests high adherence and acceptance, which needs to be interpreted in light of the associated personnel support provided within each study. The use of digital technology to deliver diet and nutrition interventions in catabolism-prone conditions is feasible, easy to adhere to, and well-accepted by participants.

ESCMID COVID-19 living guidelines: drug treatment and clinical management

ScopeIn January 2021, the ESCMID Executive Committee decided to launch a new initiative to develop ESCMID guidelines on several COVID-19-related issues, including treatment of COVID-19. MethodsAn ESCMID COVID-19 guidelines task force was established by the ESCMID Executive Committee. A small group was established, half appointed by the chair, and the remaining selected with an open call. Each panel met virtually once a week. For all decisions, a simple majority vote was used. A long list of clinical questions using the PICO (population, intervention, comparison, outcome) format was developed at the beginning of the process. For each PICO, two panel members performed a literature search with a third panellist involved in case of inconsistent results. Voting was based on the GRADE approach. Questions addressed by the guideline and recommendationsA synthesis of the available evidence and recommendations is provided for each of the 15 PICOs, which cover use of hydroxychloroquine, bamlanivimab alone or in combination with etesevimab, casirivimab combined with imdevimab, ivermectin, azithromycin and empirical antibiotics, colchicine, corticosteroids, convalescent plasma, favipiravir, remdesivir, tocilizumab and interferon β-1a, as well as the utility of antifungal prophylaxis and enoxaparin. In general, the panel recommended against the use of hydroxychloroquine, ivermectin, azithromycin, colchicine and interferon β-1a. Conditional recommendations were given for the use of monoclonal antibodies in high-risk outpatients with mild–moderate COVID-19, and remdesivir. There was insufficient evidence to make a recommendation for use of favipiravir and antifungal prophylaxis, and it was recommended that antibiotics should not be routinely prescribed in patients with COVID-19 unless bacterial coinfection or secondary infection is suspected or confirmed. Tocilizumab and corticosteroids were recommended for treatment of severe COVID-19 but not in outpatients with non-severe COVID-19. ScopeThe aim of the present guidance is to provide evidence-based recommendations for management of adults with coronavirus disease 2019 (COVID-19). More specifically, the goal is to aid clinicians managing patients with COVID-19 at various levels of severity including outpatients, hospitalized patients, and those admitted to intensive care unit. Considering the composition of the panel, mostly clinical microbiologists or infectious disease specialists with no pulmonology or intensive care background, we focus only on pharmacological treatment and do not give recommendations on oxygen supplement/support. Similarly, as no paediatricians were included in the panel; the recommendations are only for adult patients with COVID-19. Considering the current literature, no guidance was given for special populations such as the immunocompromised.

Maggot Debridement Therapy for Chronic Leg and Foot Ulcers: A Review of Randomized Controlled Trials.

To critically analyze the existing randomized controlled trials (RCTs) on the clinical, economic, and psychological implications of maggot debridement therapy (MDT). An exhaustive literature search for English-language publications was conducted using MEDLINE, EMBASE, and PubMed. Keywords used for the search were based on the PICO (Population, Intervention, Comparison, Outcome) framework. The titles, abstracts, and relevant full-text articles were screened. Seven RCTs were selected after applying the inclusion and exclusion criteria. Data pertaining to the primary and secondary outcomes of each study were extracted. The data extracted were evaluated and categorized into clinical, economic, and psychological outcomes pertaining to MDT. A judicious evaluation of these outcomes was made, and the following conclusions were drawn. There exists heterogeneity in the extant RCTs, but MDT appears to be effective for a quick early debridement. For diabetic foot ulcers, MDT improves debridement, controls infection, and enhances wound healing. In chronic peripheral vascular disease ulcers, it aids in early debridement, but the final outcome is equivocal. Further robust integrated health economic and parallel qualitative assessment studies are recommended to understand the cost-effectiveness and patient acceptability and experience.

Repetitive Transcranial Magnetic Stimulation for Neuropathic Pain on the Non-Motor Cortex: An Evidence Mapping of Systematic Reviews.

Objective This study was aimed to summarize and analyze the quality of the available evidence in systematic reviews (SRs) of repetitive transcranial magnetic stimulation (rTMS) on the non-motor cortex (non-M1) for neuropathic pain (NP) through an evidence mapping approach. Methods We follow the Global Evidence Mapping (GEM) methodology. Searches were conducted in PubMed, EMBASE, Epistemonikos, and the Cochrane Library. The study type was restricted to SRs with or without meta-analysis. All literature published before January 23, 2021, were included. The methodological quality of the included SRs was assessed using A Measurement Tool to Assess Systematic Reviews (AMSTAR-2). Data were extracted according to a defined population-intervention-comparison-outcome (PICO) framework from primary studies that included SRs. The same PICO was categorized into PICOs according to interventions (stimulation target, frequency, number of sessions (short: 1–5 sessions, medium: 5–10 sessions, and long: >10 sessions)) and comparison (sham rTMS or other targets). The evidence mapping was presented in tables and a bubble plot. Results A total of 23 SRs were included. According to the AMSTAR-2, 20 SRs scored “very low” in terms of methodological quality, 2 SRs scored “low,” and 1 SR scored “high.” A total of 17 PICOs were extracted. The dorsolateral prefrontal cortex (DLPFC) is the most studied of the non-motor cortex targets. PICOs of DLPFC, premotor cortex (PMC), frontal cortex, and secondary somatosensory cortex (S2) were mainly categorized with a “potentially better” conclusion. High-frequency (5–20 Hz) rTMS of non-M1 usually lead to “potentially better” conclusions. Conclusions DLPFC, PMC, frontal cortex, and S2 seem to be promising new targets for rTMS treatment of certain NP. Evidence mapping is a useful and reliable methodology to identify and present the existing evidence gap that more research efforts are necessary in order to highlight the optimal stimulation protocols for non-M1 targets and standardize parameters to fill the evidence gaps of rTMS. Further investigation is advised to improve the methodological quality and the reporting process of SRs.

Joint Healthcare Infection Society (HIS) and Infection Prevention Society (IPS) guidelines for the prevention and control of meticillin-resistant Staphylococcus aureus (MRSA) in healthcare facilities

Joint Healthcare Infection Society (HIS) and Infection Prevention Society (IPS) guidelines for the prevention and control of meticillin-resistant Staphylococcus aureus (MRSA) in healthcare facilities

Multiple Sclerosis International Federation guideline methodology for off-label treatments for multiple sclerosis.

BackgroundA total of 2.8 million people are living with multiple sclerosis and due to disparities in access to medicines, the ability to treat this condition varies widely. Off-label disease-modifying therapies are sometimes more available or affordable in different health systems. Appropriate methodology is integral in creating high-quality and trustworthy guidelines. In this article, we outline Multiple Sclerosis International Federation’s (MSIF) approach to creating guidelines for off-label treatments for multiple sclerosis.MethodsWe use the Guidelines International Network (GIN)-McMaster Guideline Development Checklist and the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) Evidence-to-Decision (EtD) framework. We developed detailed health descriptors for health outcomes and the panel drafted PICO (Population, Intervention, Comparator, Outcome) questions and prioritised outcomes. We collaborate with independent organisations, which systematically review and collate the information. We are actively engaging stakeholders and consulting with relevant organisations, boards, working groups and individuals.ResultsThe draft guideline recommendations will be published for open comment and stakeholders will be encouraged to endorse and disseminate the guidelines. Our methodology ensures integrity and transparency in the criteria, evidence and judgement used to make recommendations.ConclusionsThis approach will facilitate transparent creation of high-quality and trustworthy guidelines, and allow the global guidelines to be adopted or adapted into national settings.

A Systematic Review of Neurofeedback for the Management of Motor Symptoms in Parkinson's Disease.

Background: Neurofeedback has been proposed as a treatment for Parkinson’s disease (PD) motor symptoms by changing the neural network activity directly linked with movement. However, the effectiveness of neurofeedback as a treatment for PD motor symptoms is unclear. Aim: To systematically review the literature to identify the effects of neurofeedback in people with idiopathic PD; as defined by measurement of brain activity; motor function; and performance. Design: A systematic review. Included Sources and Articles: PubMed; MEDLINE; Cinhal; PsychoInfo; Prospero; Cochrane; ClinicalTrials.gov; EMBASE; Web of Science; PEDro; OpenGrey; Conference Paper Index; Google Scholar; and eThos; searched using the Population-Intervention-Comparison-Outcome (PICO) framework. Primary studies with the following designs were included: randomized controlled trials (RCTs), non-RCTs; quasi-experimental; pre/post studies; and case studies. Results: This review included 11 studies out of 6197 studies that were identified from the literature search. Neuroimaging methods used were fMRI; scalp EEG; surface brain EEG; and deep brain EEG; where 10–15 Hz and the supplementary motor area were the most commonly targeted signatures for EEG and fMRI, respectively. Success rates for changing one’s brain activity ranged from 47% to 100%; however, both sample sizes and success criteria differed considerably between studies. While six studies included a clinical outcome; a lack of consistent assessments prevented a reliable conclusion on neurofeedback’s effectiveness. Narratively, fMRI neurofeedback has the greatest potential to improve PD motor symptoms. Two main limitations were found in the studies that contributed to the lack of a confident conclusion: (1) insufficient clinical information and perspectives (e.g., no reporting of adverse events), and (2) limitations in numerical data reporting (e.g., lack of explicit statistics) that prevented a meta-analysis. Conclusions: While fMRI neurofeedback was narratively the most effective treatment; the omission of clinical outcome measures in studies using other neurofeedback approaches limits comparison. Therefore, no single neurofeedback type can currently be identified as an optimal treatment for PD motor symptoms. This systematic review highlights the need to improve the inclusion of clinical information and more robust reporting of numerical data in future work. Neurofeedback appears to hold great potential as a treatment for PD motor symptoms. However, this field is still in its infancy and needs high quality RCTs to establish its effectiveness. Review Registration: PROSPERO (ID: CRD42020191097)

Digital Mammograms with Image Enhancement Techniques for Breast Cancer Detection: A Systematic Review.

Digital mammograms with appropriate image enhancement techniques will improve breast cancer detection, and thus increase the survival rates. The objectives of this study were to systematically review and compare various image enhancement techniques in digital mammograms for breast cancer detection. A literature search was conducted with the use of three online databases namely, Web of Science, Scopus, and ScienceDirect. Developed keywords strategy was used to include only the relevant articles. A Population Intervention Comparison Outcomes (PICO) strategy was used to develop the inclusion and exclusion criteria. Image quality was analyzed quantitatively based on peak signal-noise-ratio (PSNR), Mean Squared Error (MSE), Absolute Mean Brightness Error (AMBE), Entropy, and Contrast Improvement Index (CII) values. Nine studies with four types of image enhancement techniques were included in this study. Two studies used histogram-based, three studies used frequency-based, one study used fuzzy-based and three studies used filter-based techniques. All studies reported PSNR values whilst only four studies reported MSE, AMBE, Entropy, and CII values. Filter-based was the highest PSNR values of 78.93, among other types. For MSE, AMBE, Entropy, and CII values, the highest were frequency-based (7.79), fuzzy-based (93.76), filter-based (7.92), and frequency-based (6.54) respectively. In summary, image quality for each image enhancement technique is varied, especially for breast cancer detection. In this study, the frequency-based of Fast Discrete Curvelet Transform (FDCT) via the UnequiSpaced Fast Fourier Transform (USFFT) shows the most superior among other image enhancement techniques.

CML-479: Systematic Literature Review of Treatment Patterns, Long-Term Efficacy, and Safety of Dasatinib Therapy for Patients with Chronic Myeloid Leukemia

Objectives: The tyrosine kinase inhibitors (TKIs) imatinib, dasatinib, and nilotinib are approved for the treatment of chronic myeloid leukemia (CML). It is important to evaluate differences in efficacy and safety of TKIs to help guide first-line (1L) treatment decisions. The objective of this review was to assess the treatment patterns, long-term efficacy, and safety of dasatinib compared with imatinib and nilotinib in CML. Methods: A systematic literature review (SLR) was conducted by searching Embase®, MEDLINE®, and Cochrane databases (Jan 2010 – Jul 2020). Searches of key congress abstracts (2017–2020) were performed using PRISMA guidelines and the Population, Intervention, Comparator, Outcome (PICO) criteria. Eligible interventional and real-world evidence (RWE) studies describing the treatment and switching patterns, efficacy, and safety were selected. Results: Of 224 records identified, 119 reported switching or discontinuation in ≥1L settings, and 128 reported the safety and efficacy of 1L dasatinib. Discontinuation rates for dasatinib were lower than those for imatinib and nilotinib (17/22 studies). Dasatinib elicited a faster, deeper molecular response than imatinib (3/3 randomized clinical trial studies) but a similar response to nilotinib (6/6 RWE studies). Achieving an early molecular response at 3 months (n=6) or a major molecular response (MMR) at 12 months (n=7) correlated with increased 5-year overall survival (R2=0.5946 and 0.8415, respectively). Sustained use of 1L dasatinib led to improved MMR and survival. Hematologic adverse events (AEs) were similar between dasatinib and imatinib in RWE studies (n=4; 15%–50% vs 15%–40% grade 3 AEs, respectively), but certain hematologic AEs (e.g., thrombocytopenia) were higher in clinical trials (n=4). Across all studies, cardiovascular and gastrointestinal AEs were higher in patients receiving nilotinib than dasatinib. Conclusions: This SLR demonstrates that dasatinib remains an effective long-term option for 1L treatment of patients with CML, with a lower incidence of non-hematologic AEs compared with imatinib or nilotinib. Moreover, patients were more likely to remain on dasatinib, leading to improved outcomes. Funding: Funded by Bristol Myers Squibb, Princeton, NJ, USA. Previous presentation: Reprinted from Harricharan S et al. Value Health 2021;24(suppl 1):S23. Copyright 2021, with permission from Elsevier.