The Use of Telepsychiatry Services in Emergency Settings: Scoping Review.

BACKGROUND: Telepsychiatry (TP), a live video meeting, has been implemented in many contexts and settings. It has a distinct advantage in the psychiatric emergency department (ED) setting, as it expedites expert assessments for psychiatric patients. However, limited knowledge exits for TP's effectiveness in the ED setting, as well as the process of implementing TP in this setting. OBJECTIVE: This scoping review aimed to review the existing evidence for the administrative and clinical outcomes for TP in the ED setting and to identify the barriers and facilitators to implementing TP in this setting. METHODS: The scoping review was conducted according to the guidelines for the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews). Three electronic databases were examined: PubMed, Embase, and Web of Science. The databases were searched from January 2013 to April 2023 for papers and their bibliography. A total of 2816 potentially relevant papers were retrieved from the initial search. Studies were screened and selected independently by 2 authors. RESULTS: A total of 11 articles were included. Ten papers reported on administrative and clinical outcomes of TP use in the ED setting and 1 on the barriers and facilitators of its implementation. TP is used in urban and rural areas and for settings with and with no on-site psychiatric services. Evidence shows that TP reduced waiting time for psychiatric evaluation, but in some studies, it was associated with prolonged total length of stay in the ED compared with in-person evaluation. Findings indicate lower admission rates in patients assessed with TP in the ED. Limited data were reported for TP costs, its use for involuntary commitment evaluations, and its use for particular subgroups of patients (eg, those with a particular diagnosis). A single paper examined TP implementation process in the ED, which explored the barriers and facilitators for implementation among patients and staff in a rural setting. CONCLUSIONS: Based on the extant studies, TP seems to be generally feasible and acceptable to key stakeholders. However, this review detected a gap in the literature regarding TP's effectiveness and implementation process in the ED setting. Specific attention should be paid to the examination of this service for specific groups of patients, as well as its use to enable assessments for possible involuntary commitment.

The Use of Metabolomes in Risk Stratification of Heart Failure Patients: Protocol for a Scoping Review.

BACKGROUND: Heart failure (HF) is a significant health problem that is often associated with major morbidity and mortality. Metabolic abnormalities occur in HF and may be used to identify individuals at risk of developing the condition. Furthermore, these metabolic changes may play a role in the pathogenesis and progression of HF. Despite this knowledge, the utility of metabolic changes in diagnosis, management, prognosis, and therapy for patients with chronic HF has not been systematically reviewed. OBJECTIVE: This scoping review aims to systematically appraise the literature on metabolic changes in patients with HF, describe the role of these changes in pathogenesis, progression, and care, and identify knowledge gaps to inform future research. METHODS: This review will be conducted using a strategy based on previous reports, the JBI Manual for Evidence Synthesis, and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Extension for Scoping Reviews (PRISMA-ScR) guidelines. A comprehensive search of electronic databases (Medline, EBSCOhost, Scopus, and Web of Science) will be conducted using keywords related to HF, myocardial failure, metabolomes, metabonomics, and analytical chemistry techniques. The search will include original peer-reviewed research papers (clinical studies conducted on humans and systematic reviews with or without a meta-analysis) published between January 2010 and September 2023. Studies that include patients with HF younger than 18 years or those not published in English will be excluded. Two authors (UGA and MB) will screen the titles and abstracts independently and perform a full-text screen of the relevant and eligible papers. Relevant data will be extracted and synthesized, and a third author or group will be consulted to resolve discrepancies. RESULTS: This scoping review will span from January 2010 to September 2023, and the results will be published in a peer-reviewed, open-access journal as a scoping review in 2024. The presentation of the findings will use the PRISMA-ScR flow diagram and descriptive and narrative formats, including tables and graphical displays, to provide a comprehensive overview of the extracted data. CONCLUSIONS: This review aims to collect and analyze the available evidence on metabolic changes in patients with HF, aiming to enhance our current understanding of this topic. Additionally, this review will identify the most commonly used and suitable sample, analytical method, and specific metabolomes to facilitate standardization, reproducibility of results, and application in the diagnosis, treatment, and risk stratification of patients with HF. Finally, it is hoped that this review's outcomes will inspire further research into the metabolomes of patients with HF in low- and middle-income countries. TRIAL REGISTRATION: Open Science Framework; https://osf.io/sp6xj. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/53905.

Exploring the Use and Implications of AI in Sexual and Reproductive Health and Rights: Protocol for a Scoping Review.

BACKGROUND: Artificial intelligence (AI) has emerged as a transformative force across the health sector and has garnered significant attention within sexual and reproductive health and rights (SRHR) due to polarizing views on its opportunities to advance care and the heightened risks and implications it brings to people's well-being and bodily autonomy. As the fields of AI and SRHR evolve, clarity is needed to bridge our understanding of how AI is being used within this historically politicized health area and raise visibility on the critical issues that can facilitate its responsible and meaningful use. OBJECTIVE: This paper presents the protocol for a scoping review to synthesize empirical studies that focus on the intersection of AI and SRHR. The review aims to identify the characteristics of AI systems and tools applied within SRHR, regarding health domains, intended purpose, target users, AI data life cycle, and evidence on benefits and harms. METHODS: The scoping review follows the standard methodology developed by Arksey and O'Malley. We will search the following electronic databases: MEDLINE (PubMed), Scopus, Web of Science, and CINAHL. Inclusion criteria comprise the use of AI systems and tools in sexual and reproductive health and clear methodology describing either quantitative or qualitative approaches, including program descriptions. Studies will be excluded if they focus entirely on digital interventions that do not explicitly use AI systems and tools, are about robotics or nonhuman subjects, or are commentaries. We will not exclude articles based on geographic location, language, or publication date. The study will present the uses of AI across sexual and reproductive health domains, the intended purpose of the AI system and tools, and maturity within the AI life cycle. Outcome measures will be reported on the effect, accuracy, acceptability, resource use, and feasibility of studies that have deployed and evaluated AI systems and tools. Ethical and legal considerations, as well as findings from qualitative studies, will be synthesized through a narrative thematic analysis. We will use the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) format for the publication of the findings. RESULTS: The database searches resulted in 12,793 records when the searches were conducted in October 2023. Screening is underway, and the analysis is expected to be completed by July 2024. CONCLUSIONS: The findings will provide key insights on usage patterns and evidence on the use of AI in SRHR, as well as convey key ethical, safety, and legal considerations. The outcomes of this scoping review are contributing to a technical brief developed by the World Health Organization and will guide future research and practice in this highly charged area of work. TRIAL REGISTRATION: OSF Registries osf.io/ma4d9; https://osf.io/ma4d9. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/53888.

Use of Biological Feedback as a Health Behavior Change Technique in Adults: Scoping Review.

BACKGROUND: Recent advancements in personal biosensing technology support the shift from standardized to personalized health interventions, whereby biological data are used to motivate health behavior change. However, the implementation of interventions using biological feedback as a behavior change technique has not been comprehensively explored. OBJECTIVE: The purpose of this review was to (1) map the domains of research where biological feedback has been used as a behavior change technique and (2) describe how it is implemented in behavior change interventions for adults. METHODS: A comprehensive systematic search strategy was used to query 5 electronic databases (Ovid MEDLINE, Elsevier Embase, Cochrane Central Register of Controlled Trials, EBSCOhost PsycINFO, and ProQuest Dissertations & Theses Global) in June 2021. Eligible studies were primary analyses of randomized controlled trials (RCTs) in adults that incorporated biological feedback as a behavior change technique. DistillerSR was used to manage the literature search and review. RESULTS: After removing 49,500 duplicates, 50,287 articles were screened and 767 articles were included. The earliest RCT was published in 1972 with a notable increase in publications after 2000. Biological feedback was most used in RCTs aimed at preventing or managing diabetes (n=233, 30.4%), cardiovascular disease (n=175, 22.8%), and obesity (n=115, 15%). Feedback was often given on multiple biomarkers and targeted multiple health behaviors. The most common biomarkers used were anthropometric measures (n=297, 38.7%), blood pressure (n=238, 31%), and glucose (n=227, 29.6%). The most targeted behaviors were diet (n=472, 61.5%), physical activity (n=417, 54.4%), and smoking reduction (n=154, 20.1%). The frequency and type of communication by which biological feedback was provided varied by the method of biomarker measurement. Of the 493 (64.3%) studies where participants self-measured their biomarker, 476 (96.6%) received feedback multiple times over the intervention and 468 (94.9%) received feedback through a biosensing device. CONCLUSIONS: Biological feedback is increasingly being used to motivate behavior change, particularly where relevant biomarkers can be readily assessed. Yet, the methods by which biological feedback is operationalized in intervention research varied, and its effectiveness remains unclear. This scoping review serves as the foundation for developing a guiding framework for effectively implementing biological feedback as a behavior change technique. TRIAL REGISTRATION: Open Science Framework Registries; https://doi.org/10.17605/OSF.IO/YP5WAd. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/32579.

Defining Misinformation and Related Terms in Health-Related Literature: Scoping Review.

BACKGROUND: Misinformation poses a serious challenge to clinical and policy decision-making in the health field. The COVID-19 pandemic amplified interest in misinformation and related terms and witnessed a proliferation of definitions. OBJECTIVE: We aim to assess the definitions of misinformation and related terms used in health-related literature. METHODS: We conducted a scoping review of systematic reviews by searching Ovid MEDLINE, Embase, Cochrane, and Epistemonikos databases for articles published within the last 5 years up till March 2023. Eligible studies were systematic reviews that stated misinformation or related terms as part of their objectives, conducted a systematic search of at least one database, and reported at least 1 definition for misinformation or related terms. We extracted definitions for the terms misinformation, disinformation, fake news, infodemic, and malinformation. Within each definition, we identified concepts and mapped them across misinformation-related terms. RESULTS: We included 41 eligible systematic reviews, out of which 32 (78%) reviews addressed the topic of public health emergencies (including the COVID-19 pandemic) and contained 75 definitions for misinformation and related terms. The definitions consisted of 20 for misinformation, 19 for disinformation, 10 for fake news, 24 for infodemic, and 2 for malinformation. "False/inaccurate/incorrect" was mentioned in 15 of 20 definitions of misinformation, 13 of 19 definitions of disinformation, 5 of 10 definitions of fake news, 6 of 24 definitions of infodemic, and 0 of 2 definitions of malinformation. Infodemic had 19 of 24 definitions addressing "information overload" and malinformation had 2 of 2 definitions with "accurate" and 1 definition "used in the wrong context." Out of all the definitions, 56 (75%) were referenced from other sources. CONCLUSIONS: While the definitions of misinformation and related terms in the health field had inconstancies and variability, they were largely consistent. Inconstancies related to the intentionality in misinformation definitions (7 definitions mention "unintentional," while 5 definitions have "intentional"). They also related to the content of infodemic (9 definitions mention "valid and invalid info," while 6 definitions have "false/inaccurate/incorrect"). The inclusion of concepts such as "intentional" may be difficult to operationalize as it is difficult to ascertain one's intentions. This scoping review has the strength of using a systematic method for retrieving articles but does not cover all definitions in the extant literature outside the field of health. This scoping review of the health literature identified several definitions for misinformation and related terms, which showed variability and included concepts that are difficult to operationalize. Health practitioners need to exert caution before labeling a piece of information as misinformation or any other related term and only do so after ascertaining accurateness and sometimes intentionality. Additional efforts are needed to allow future consensus around clear and operational definitions.

Fertility Preservation Techniques in Neuro-Oncology Patients: Protocol for a Systematic Review.

BACKGROUND: Advancements in cancer treatments have successfully improved central nervous system (CNS) cancer survivorship and overall quality of life. As a result, the awareness of the importance of fertility preservation techniques is increasing. Currently, a range of established techniques, such as oocyte cryopreservation and sperm cryopreservation, are available. However, oncologists may be hesitant to refer patients to a reproductive specialist. OBJECTIVE: The primary aim of the proposed systematic review is to assess the best evidence for fertility preservation techniques used in patients with CNS cancers. It also aims to evaluate outcomes related to their success and complications. METHODS: This protocol was produced in adherence with the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols). Electronic databases will be systematically searched to identify studies that meet our eligibility criteria. Studies will be included if they report at least one type of fertility preserving or sparing technique in male patients of any age and female patients aged <35 years. Animal studies, non-English studies, editorials, and guidelines will be excluded from the review. From the included studies, data will be extracted and synthesized by using a narrative approach and summarized in tables. The primary outcome will be the number of patients successfully undergoing a fertility preservation technique. The secondary outcomes will include the number of retrieved oocytes, the number of oocytes or embryos vitrified for cryopreservation, clinical pregnancy, and live birth. The quality of the included studies will be assessed by using the National Heart, Lung, and Blood Institute risk-of-bias tool for any type of study. RESULTS: The systematic review is expected to be completed by the end of 2023, and results will be published in a peer-reviewed journal and on PROSPERO. CONCLUSIONS: The proposed systematic review will summarize the fertility preservation techniques available for patients with CNS cancers. Given the improvement in cancer survivorship, it is becoming increasingly important to educate patients about fertility preservation techniques. There are likely to be several limitations to this systematic review. Current literature is likely to be of low quality due to insufficient numbers, and there may be difficulty in accessing data sets. However, it is our hope that the results from the systematic review provide an evidence base to help inform the referral of patients with CNS cancers for fertility preservation treatments. TRIAL REGISTRATION: PROSPERO CRD42022352810; https://tinyurl.com/69xd9add. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/44825.

Decolonization in Sexual and Reproductive Health Research Methods: Protocol for a Scoping Review.

BACKGROUND: As researchers and implementors begin to acknowledge the repercussions of institutionalized colonialism on community and individual health, the need to decolonize research has become clear. Despite this, there is neither a singular definition of decolonizing methodologies nor an overview of the shared principles and characteristics of decolonized research needed to codify this work as common practice in global health. OBJECTIVE: The review will identify papers that reference principles of decolonization and identify shared characteristics between them. The aim of this scoping review is to review decolonized research methodologies through the lens of sexual health as a step in creating a shared understanding of best practices. We will further examine the tools and methods used to collect and analyze data within the included studies. METHODS: The protocol for this scoping review was developed using the framework from the Joanna Briggs Institute and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews). The search strategy will comprise a search of electronic databases (JSTOR, Embase, EMCare, MEDLINE [Ovid], Global Health Database, Web of Science), gray literature sources, and key studies. Titles and abstracts will be reviewed by 2 or more independent reviewers against inclusion criteria. Bibliometric details, study design, methodology, community involvement, and other indicators will be collected using a data extraction tool developed for this review. Extracted data will be analyzed using descriptive statistics and qualitative analysis of content and themes to identify common practices in decolonized methodologies within sexual health. Narrative summaries will be used to describe results in relation to the research question, and identified gaps will be discussed. RESULTS: The initial title or abstract review of 4967 studies identified by the search strategy was completed in November 2022. In total, 1777 studies met initial inclusion criteria and were sent to a second round of title or abstract review, which was completed in January 2023. In total, 706 studies were downloaded for full-text inclusion, which is expected to be completed by April 2023. We aim to complete data extraction and analysis by May 2023 and expect to publish the findings by the end of July 2023. CONCLUSIONS: There remains a gap in the research on the meaning and application of decolonized research strategies, particularly within sexual and reproductive health. The findings of this study will contribute to a shared definition of decolonized methodologies and how they can be applied as a common practice in global health research. Applications include the development of decolonized frameworks, theoretical discourses, and methodologies. The study will inform the design and implementation of future decolonized research and evaluation strategies, particularly around sexual and reproductive health. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45771.

The Effects of Online Self-management Interventions for Patients With Mood Disorders: Protocol for a Systematic Review and Meta-analysis.

BACKGROUND: Self-management has become important as a complementary approach to the recovery of patients with mood disorders, and the need for a remote intervention program has been revealed in relation to the COVID-19 pandemic. OBJECTIVE: The aim of this review is to systematically review the studies for evidence on the effects of online self-management interventions based on cognitive behavioral therapy or psychoeducation for patients with mood disorders and to verify the statistical significance of the effectiveness of the interventions. METHODS: A comprehensive literature search will be conducted using a search strategy in nine electronic bibliographic databases and will include all randomized controlled trial studies conducted up through December 2021. In addition, unpublished dissertations will be reviewed to minimize publication bias and to include a wider range of research. All steps in selecting the final studies to be included in the review will be performed independently by two researchers, and any discrepancies will be resolved through discussion. RESULTS: Institutional review board approval was not required because this study was not conducted on people. Systematic literature searches, data extraction, narrative synthesis, meta-analysis, and final writing of the systematic review and meta-analysis are expected to be completed by 2023. CONCLUSIONS: This systematic review will provide a rationale for the development of web-based or online self-management interventions for the recovery of patients with mood disorders and will be used as a clinically meaningful reference in terms of mental health management. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45528.

Investigation of individual nurses' relative hand hygiene performance using an anonymous automated electronic hand hygiene monitoring system and a nursing assignment schedule.

BACKGROUND: We investigated whether an anonymous automated electronic monitoring system (EMS) could be used to compare hand hygiene (HH) performance of individual nurses. METHODS: Prospective observational cohort study. HH performance in 10 acute-care patient rooms was estimated through an EMS that anonymously measured HH events, and room entries and exits. The association between patient room's HH compliance and the nurse in charge of each room was investigated by comparing percentile rank distributions, and through a negative binomial model. RESULTS: Over 99 days, there were 38,596 HH events and 135,546 room entries and exits (global HH performance, 28%). For 10 of 54 (19%) nurses, the median HH percentile rank of the rooms to which they were assigned was higher than the group average (P < .001; range of percentiles, 64th to 85th). A lower median percentile was seen in 9/54 (17%) participants (P < .001; range of percentiles, 22nd to 39th). The negative binomial model confirmed this association and identified 15 of 54 high performers (range of adjusted incidence rate ratios [aIRR], 1.17-1.83) and 16 of 54 low performers (range of aIRR, 0.37-0.77). DISCUSSION AND CONCLUSIONS: An association exists between a room's HH rate and its assigned nurse. This association could hold potential value for an individualized feedback strategy.

Problems and Barriers Related to the Use of Digital Health Applications: Protocol for a Scoping Review.

BACKGROUND: The use of mobile health (mHealth) apps is increasing rapidly worldwide. More and more institutions and organizations develop regulations and guidelines to enable an evidence-based and safe use. In Germany, mHealth apps fulfilling predefined criteria (Digitale Gesundheitsanwendungen [DiGA]) can be prescribed and are reimbursable by the German statutory health insurance scheme. Due to the increasing distribution of DiGA, problems and barriers should receive special attention. OBJECTIVE: This study aims to identify the relevant problems and barriers related to the use of mHealth apps fulfilling the criteria of DiGA. METHODS: This scoping review will follow published methodological frameworks and the PRISMA-Scr (Preferred Reporting Items for Systematic Reviews and Meta-analyses Extension for Scoping Reviews) criteria. Electronic databases (MEDLINE, EMBASE, PsycINFO, and JMIR), reference lists of relevant articles, and grey literature sources will be searched. Two reviewers will assess the eligibility of the articles by a two-stage (title and abstract as well as full text) screening process. Only problems and barriers related to mHealth apps fulfilling the criteria of DiGA are included for this research. The identified studies will be categorized and analyzed with MAXQDA. RESULTS: This scoping review gives an overview of the available evidence and identifies research gaps regarding problems and barriers related to DiGA. The results are planned to be submitted to an indexed, peer-reviewed journal in the first quarter of 2022. CONCLUSIONS: This is the first review to identify the problems and barriers related to the use of mHealth apps fulfilling the German definition of DiGA. Nevertheless, the findings can be applied to other contexts and health care systems as well. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/32702.

Use of Prescribed Drugs to Treat Chronic Diseases during Pregnancy in Outpatient Care in Switzerland between 2014 and 2018: Descriptive Analysis of Swiss Health Care Claims Data.

Evidence on the use of drugs during pregnancy in Switzerland is lacking. We aimed to evaluate the utilisation of drugs to treat chronic diseases during pregnancy in Switzerland. We identified all pregnancies (excluding abortions) in Swiss Helsana claims data (2014-2018). In those, we identified all claims for drugs to treat a chronic disease, which typically affects women of childbearing age. Potentially teratogenic/fetotoxic drugs were evaluated during specific risk periods. Results were demographically weighted relative to the Swiss population. We identified claims for ≥1 drug of interest during 22% of 369,371 weighted pregnancies. Levothyroxine was most frequently claimed (6.6%). Antihypertensives were claimed during 5.3% (3.9% nifedipine in T3). Renin-Angiotensin-Aldosterone System (RAAS) inhibitors were dispensed to 0.3/10,000 pregnancies during trimester 2 (T2) or trimester 3 (T3). Insulin was claimed during 3.5% of pregnancies, most frequently in T3 (3.3%). Exposure to psychotropic drugs was 3.8% (mostly Selective serotonin reuptake inhibitors (SSRIs)) and to drugs for obstructive airway diseases 3.6%. Traditional immunosuppressants (excluding corticosteroids) were claimed during 0.5% (mainly azathioprine and hydroxychloroquine), biologic immunosuppressants (Tumour necrosis factor-alpha (TNF-alpha) inhibitors and interleukin inhibitors) during 0.2%, and drugs to treat multiple sclerosis during 0.09% of pregnancies. Antiretrovirals were claimed during 0.15% of pregnancies. Patterns of drug claims were in line with treatment recommendations, but relatively rare events of in utero exposure to teratogenic drugs may have had severe implications for those involved.

Should a prescription database be used to search uncontrolled severe asthmatics?

INTRODUCTION: Many uncontrolled severe asthmatics are not on biologic therapy. We hypothesized that using a prescription database could help us identify them. MATERIAL AND METHODS: 3,309 patients who received at least one Montelukast prescription in 2019 were extracted from our prescription database. Number of packages/year, types and dosages of ICS, LABA, ICS/LABA, LAMA and monoclonal antibodies were considered for each patient. In our analysis, for subjects that took > 7 packages of ICS/LABA + LTRA +/- LAMA (high adherent) the number of oral corticosteroids (OC) packets prescribed for each of them was also looked upon. RESULTS: Patients that took ICS/LABA or ICS/LABA + LAMA continuously with high ICS doses were 188 (25.6%) and 117 (39.3%) respectively (total: 305 - 29.5%). Among them, 58 (30.9%) and 53 (45.3%) (total: 111 - 36.4%) were prescribed more than 2 OC packages. Whereas, 21 (11.2%) and 24 (20.5%) patients (total: 45 - 14.75%) received at least 4 OC package prescriptions. CONCLUSION: Approximately 36% of patients in continuous step-4/5 of GINA guidelines treatment may have severe uncontrolled asthma (overusing OC) which needed biologic treatment. In our opinion, a prescription archiving database may be a tool that can help us identify such uncontrolled asthma patients.

Demographic, tumour, and treatment characteristics of female patients with breast cancer in Sri Lanka; results from a hospital-based cancer registry.

BACKGROUND: Although breast cancer is the most common cancer among Sri Lankan women, there is little published data on patient characteristics and treatment in the local context. We aimed to describe disease characteristics and management in a large contemporary cohort of women with breast cancer at the National Cancer Institute of Sri Lanka (NCISL). METHODS: All women with invasive primary breast cancers diagnosed during 2016-2020 were identified from the NCISL breast cancer registry. The NCISL sees approximately 40% of all cancer patients in Sri Lanka. Cancer stage at diagnosis was defined according to the Tumour, Node, and Metastasis (TNM) staging system and the Estrogen (ER) and progesterone (PR) receptor status was determined based on the results of immunohistochemistry tests. Descriptive statistics were used to describe the study cohort and treatment patterns. RESULTS: Over 5100 patients were diagnosed with breast cancer during the study period at the NCISL. The mean age of the women was 56 (SD 12) years. Common co-morbidities were hypertension (n = 1566, 30%) and diabetes mellitus (n = 1196, 23%). Two thirds (66%) of the cancers were early stage (stage I & II) at diagnosis. ER/PR positivity rate was 72% and HER-2 positivity rate was 22%. Two thirds of the women had undergone mastectomy while 68% had undergone axillary clearance. The rate of chemotherapy delivery was 91% for women with node positive disease while 77% of eligible women (i.e., after wide local excision or with > 3 positive lymph nodes) had received adjuvant radiotherapy. Endocrine therapy was initiated in 88% of eligible women with hormone receptor positive disease while rate of trastuzumab use was 59% among women with HER2 positive breast cancer. CONCLUSIONS: High percentage of advanced breast cancer at diagnosis and high prevalence of comorbidities are some of the major challenges faced in the management of breast cancer in Sri Lanka. Given that stage at diagnosis is the most important prognostic factor determining survival, greater efforts are needed to promote early diagnosis of breast cancer. Considerable lapses in the concordance between guideline recommendations and the delivery of cancer care warrants closer assessment and intervention.

Use of real-world evidence for oncology clinical decision making in emerging economies.

Real-world evidence (RWE) can provide insights into patient profiles, disease detection, treatment choice, dosing strategies, treatment sequencing, adverse event management and financial toxicity associated with oncology treatment. However, the full potential of RWE is untapped in emerging economies due to structural and behavioral factors. Structural barriers include lack of regulatory engagement, real-world data availability, quality and integrity. Behavioral barriers include entrenched healthcare professional behaviors that impede rapid RWE understanding and adoption. These barriers can be addressed with close collaboration of healthcare stakeholders; of whom, regulators need to be at the forefront given their ability to facilitate use of RWE in healthcare policy and legislation.

Lay abstract Traditionally, randomized clinical trials have been used to provide insights on new medical therapies and continue to remain the gold standard for approval. The-increasing availability of patient level data in the real-world, it is now possible to generate evidence regarding the usage and potential benefits or risks of a medical therapy derived from analysis of real-world data. This evidence is collectively referred to real-world evidence (RWE). randomized clinical trials and RWE are complementary and the area of Oncology especially benefits from RWE to guide clinical decision making across the patient journey. Key benefits include cancer screening and diagnosis, optimal treatment choices (including personalized medicine) and disease management such as dosing and treatment of side effects. In recent times, RWE generation in oncology has been prolific in the USA and western Europe. With expansive biopharmaceutical investments into infrastructure harnessing patient-level data and greater local regulatory guidance, oncology patients in emerging economies may now also have the opportunity to benefit from clinical decision making informed by RWE.

Identifying Ectopic Pregnancy in a Large Integrated Health Care Delivery System: Algorithm Validation.

BACKGROUND: Surveillance of ectopic pregnancy (EP) using electronic databases is important. To our knowledge, no published study has assessed the validity of EP case ascertainment using electronic health records. OBJECTIVE: We aimed to assess the validity of an enhanced version of a previously validated algorithm, which used a combination of encounters with EP-related diagnostic/procedure codes and methotrexate injections. METHODS: Medical records of 500 women aged 15-44 years with membership at Kaiser Permanente Southern and Northern California between 2009 and 2018 and a potential EP were randomly selected for chart review, and true cases were identified. The enhanced algorithm included diagnostic/procedure codes from the International Classification of Diseases, Tenth Revision, used telephone appointment visits, and excluded cases with only abdominal EP diagnosis codes. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall performance (Youden index and F-score) of the algorithm were evaluated and compared to the validated algorithm. RESULTS: There were 334 true positive and 166 true negative EP cases with available records. True positive and true negative EP cases did not differ significantly according to maternal age, race/ethnicity, and smoking status. EP cases with only one encounter and non-tubal EPs were more likely to be misclassified. The sensitivity, specificity, PPV, and NPV of the enhanced algorithm for EP were 97.6%, 84.9%, 92.9%, and 94.6%, respectively. The Youden index and F-score were 82.5% and 95.2%, respectively. The sensitivity and NPV were lower for the previously published algorithm at 94.3% and 88.1%, respectively. The sensitivity of surgical procedure codes from electronic chart abstraction to correctly identify surgical management was 91.9%. The overall accuracy, defined as the percentage of EP cases with correct management (surgical, medical, and unclassified) identified by electronic chart abstraction, was 92.3%. CONCLUSIONS: The performance of the enhanced algorithm for EP case ascertainment in integrated health care databases is adequate to allow for use in future epidemiological studies. Use of this algorithm will likely result in better capture of true EP cases than the previously validated algorithm.

Investigation of the association between metabolic syndrome and breast cancer patients.

One of the most serious cancers among women is breast cancer. This disease is the first reason for the death of women due to cancer. Increasing breast cancer risk may associate with many factors including genetic, reproductive factors, people's lifestyle, metabolic syndrome (MS) and hormones. MS has been known as a risk factor for prostate, pancreatic, breast and colorectal cancers. The purpose of this review is to identify the relationship between MS components and breast cancer individually. This study was performed by researching electronic database references including PubMed, Google Scholar, CINAHL ProQuest, and web of science through 2019. The effect of MS with its components and breast cancer was reported in many studies. Nevertheless, a thorough understanding of the mechanisms involved remains a challenge. However, one can take several preventive measures, including a proper diet, which is one of the most important determinants of metabolic status. Also, general preventive recommendations are including reducing alcohol consumption, red meat and total fat in the diet. Moreover, increasing the consumption of vegetable and fruit reduce the proportion of MS patients to improve the outcome of breast cancer patients.

Risk of schizophrenia in relatives of individuals affected by schizophrenia: A meta-analysis.

A meta-analysis was conducted to estimate schizophrenia incidence in first-degree relatives (FDRs) of probands diagnosed with schizophrenia. The aim was to inform future schizophrenia research and improve accuracy of risk communication to patients. Schizophrenia risk in FDRs with 1 or 2 probands with schizophrenia was investigated by conducting a systematic review of cohort and case-control studies with the following criteria: published between 1977 and 2018; reported odds ratios (OR), relative risk (RR) or sufficient raw data to calculate OR or RR; used appropriate diagnostic criteria; and reported systematic proband recruitment and ascertainment of relatives. Studies were obtained via EMBASE and MEDLINE electronic database searches. From an initial 5755 articles, 19 met the inclusion criteria. Mean effect sizes across studies were estimated using random effects methods. Estimates for schizophrenia risk were OR = 7.69 (95% CI 5.11-11.56) for FDRs of one proband with schizophrenia compared to healthy control probands, increasing to OR = 11.11 (95% CI = 1.45-85.02) for FDRs with two probands with schizophrenia. These findings support the existing literature suggesting significant genetic liability for schizophrenia. The results can be used to educate individuals with a family history of schizophrenia about their risk.

TECLA-an innovative technical approach for prostate cancer registries.

Objective: To present a code-driven, electronic database for patients TrEated with robotic-assisted radiCaL prostAtectomy (TECLA), developed at Innlandet Hospital (IH), Trust, Norway, for research, local quality control and to deliver data to the National Cancer Registry of Norway (CRN). Clinical data are directly extracted from the structured documentation in the electronic medical record (EMR).Materials and methods: The urological department at IH treats about 200 patients with robotic-assisted radical prostatectomy (RARP) annually. All consenting patients registered with the procedure code for RARP are included in TECLA. Clinical data are obtained automatically from the EMR, by structured forms. Patient-reported outcome and experience measures (PROMs and PREMs) are filled in by the patients on an iPad or a smartphone.Results: The basic construct of TECLA is presented. From August 2017 to June 2018, 200 men were treated with RARP, of which 182 (91%) provided consent for inclusion in the register. Of these, 97% completed the PROM survey before treatment and 91% at 3 months follow-up. PREMs were completed by 78%. All clinical variables for the hospital stay and for the 6-week follow-up were more than 95% complete.Conclusion: This entirely electronic surgical quality register is easy to use, both for patients and clinicians, and has a high capture rate. The data collection is linked to the clinicians' workflow, without double data entry, so entering data does not add any extra work. The register design can be used by other hospitals for various surgical procedures.

Reliability of a Canadian database for primary care nursing services' clinical and administrative data.

BACKGROUND: The use of electronic clinical and administrative data can be an advantageous source of information for assessing nursing performance in primary care. In Québec (Canada), the I-CLSC electronic database could be used to measure performance indicators. However, little is known about the reliability of the data contained in this database. The objective of this study was to assess the reliability of the clinical and administrative data contained in the I-CLSC electronic database based on the data entered in medical records. METHODS: We used a longitudinal design for this study. A sample of 100 patients who had experienced 107 episodes of wound care were randomly selected from all patients who had two or more consultations during the year 2015. The paper records were used as reference. We collected data regarding eight nursing sensitive indicators from both sources. We assessed the concordance between the electronic data and the paper records by measuring inter-rater agreement. RESULTS: Six of the eight indicators showed a percentage agreement ≥ 85%, and kappa scores between 0.7 and 1.00 (p < 0.001), indicating high to perfect levels of agreement between the two data sources. Two indicators presented fair kappa scores. CONCLUSION: This database provides reliable data relating to the organization of care but shows lower reliability for specific acts performed by nurses in primary care. This existing database can be used to assess, manage and improve certain dimensions of nursing performance in primary care.

Using Big Data in oncology to prospectively impact clinical patient care: A proof of concept study.

OBJECTIVE: Big Data is widely seen as a major opportunity for progress in the practice of personalized medicine, attracting the attention from medical societies and presidential teams alike as it offers a unique opportunity to enlarge the base of evidence, especially for older patients underrepresented in clinical trials. This study prospectively assessed the real-time availability of clinical cases in the Health & Research Informatics Total Cancer Care™ (TCC) database matching community patients with cancer, and the impact of such a consultation on treatment. MATERIALS AND METHODS: Patients aged 70 and older seen at the Lynn Cancer Institute (LCI) with a documented malignancy were eligible. Geriatric screening information and the oncologist's pre-consultation treatment plan were sent to Moffitt. A search for similar patients was done in TCC and additional information retrieved from Electronic Medical Records. A report summarizing the data was sent and the utility of such a consultation was assessed per email after the treatment decision. RESULTS: Thirty one patients were included. The geriatric screening was positive in 87.1% (27) of them. The oncogeriatric consultation took on average 2.2 working days. It influenced treatment in 38.7% (12), and modified it in 19.4% (6). The consultation was perceived as "somewhat" to "very useful" in 83.9% (26). CONCLUSION: This study establishes a proof of concept of the feasibility of real time use of Big Data for clinical practice. The geriatric screening and the consultation report influenced treatment in 38.7% of cases and modified it in 19.4%, which compares very well with oncogeriatric literature. Additional steps are needed to render it financially and clinically viable.