Search

Neonatal seizures (NS) represent an important clinical manifestation among critically ill infants and are often the first sign of underlying brain injury. Early recognition and treatment are essential to reduce morbidity and mortality. The present study investigated the NS management and treatment approaches employed by level II/III neonatal intensive care units (NICUs) across the United States to identify areas of consensus and variability. Personnel associated with level II/III NICUs were directly surveyed with an electronic questionnaire. Access to neurology specialists, on-site electroencephalography (EEG) monitoring, and use of antiseizure medications was directly queried. A total of 51 NICUs participated in this survey. Twenty-five percent of the surveyed NICUs reported having an established clinical practice pathway available for treating NS. Twenty-four percent endorsed having written guidelines that provided a formal definition for the concept of "neonatal seizures." Although the majority of NICUs reported having phenobarbital available for rapid seizure management, most NICUs lacked access to additional antiseizure medications for treatment escalation. Twenty-four percent of the surveyed NICUs had no access to EEG monitoring available to them on-site. Daytime and overnight access to neurology consultants was limited and variable. Findings were consistent with a lack of equitable access for NS treatment. Areas of potential improvement include development and implementation of a protocol for rapidly treating NS that emphasizes enhanced access to EEG and rapid neurology consultation, acknowledging and improving upon resource limitations. These developments may eventually provide earlier detection, evaluation, and treatment of seizures in newborns, contributing to improved long-term outcomes. [ABSTRACT FROM AUTHOR]

Background: Clinical trials comparing the efficacy of ocrelizumab (OCR) with other disease-modifying therapies (DMTs) other than interferon (IFN) β-1a in relapsing multiple sclerosis (RMS) are lacking. Objectives: To compare the treatment effect of OCR vs six DMTs' (IFN β-1a, glatiramer acetate, fingolimod, dimethyl fumarate, teriflunomide, natalizumab) treatment pathways used in clinical practice by combining clinical trial and real-world data. Methods: Patient-level data from OPERA trials and open-label extension phase, and from the German NeuroTransData (NTD) MS registry, were used to build 1:1 propensity score-matched (PSM) cohorts controlling for seven baseline covariates, including brain imaging activity. Efficacy outcomes were time to first relapse and time to 24-week confirmed disability progression over 5.5 years of follow-up. Intention-to-treat analysis using all outcome data irrespective of treatment switch was applied. Results: The analyses included 611 OPERA patients and 7141 NTD patients. We built 12 paired-matched cohorts (six for each outcome, two for each DMT) to compare efficacy of OCR in OPERA with each DMT treatment pathway in NTD. Post-matching, baseline covariates and PS were well balanced (standardized mean difference <.2 for all cohorts). Over 5.5 years, patients treated with OCR showed a statistically significant reduction in the risk of relapse (hazard ratios [HRs].30 to.54) and disability progression (HRs.51 to.67) compared with all index therapies and their treatment switching pathways in NTD. Treatment switch and/or discontinuation occurred frequently in NTD cohorts. Conclusion: OCR demonstrates superiority in controlling relapses and disability progression in RMS compared with real-world treatment pathways over a 5.5-year period. These analyses suggest that high-efficacy DMTs and high treatment persistence are critical to achieve greatest clinical benefit in RMS. Registration: OPERA I (NCT01247324), OPERA II (NCT01412333) [ABSTRACT FROM AUTHOR]

With the deepening of aging in China, the prevalence of diabetes in older people has increased noticeably, and standardized diabetes management is critical for improving clinical outcomes of diabetes in older people. In 2021, the National Center of Gerontology, Chinese Society of Geriatrics, and Diabetes Professional Committee of Chinese Aging Well Association organized experts to write the first guideline for diabetesdiagnosis and treatment in older people in China, the Guideline for the Management of Diabetes Mellitus in the Elderly in China (2021 edition). The guideline emphasizes that older patients with diabetes are a highly heterogeneous group requiring comprehensive assessment and stratified and individualized management strategies. The guideline proposes simple treatments and de-intensified treatment strategies for older patients with diabetes. This edition of the guideline provides clinicians with practical and operable clinical guidance, thus greatly contributing to the comprehensive and full-cycle standardized management of older patients with diabetes in China and promoting the extensive development of clinical and basic research on diabetes in older people and related fields. In the past 3 years, evidence-based medicine for older patients with diabetes and related fields has further advanced, and new treatment concepts, drugs, and technologies have been developed. The guideline editorial committee promptly updated the first edition of the guideline and compiled the Guideline for the Management of Diabetes Mellitus in the Elderly in China (2024 edition). More precise management paths for older patients with diabetes are proposed, for achieving continued standardization of the management of older Chinese patients with diabetes and improving their clinical outcomes.

Treatment resistant depression (TRD) is considered when an individual fails to respond to two or more different antidepressants in adequate doses, duration and with adequate adherence within the same major depressive episode. To examine the clinical profiles of TRD patients through data from electronic healthcare records and compare characteristics and treatment pathways of ethnic minority and non-minority patients in UK. A retrospective, longitudinal, observational cohort study of patients with TRD was carried out in 10 Mental Health NHS Foundation Trusts in the Akrivia Health/UK Clinical Record Interactive Search (CRIS) system network. The CRIS system was used as a means of analysing de-identified data across 3.2 million anonymised patients' records. 10,048 patient records were deemed eligible for this study, of which 20.2 % of patients identified as BAME, and 79.8 % patients identified as White. Overall, around half of the patients were likely to be prescribed an antidepressant within 2 months of the MDD diagnosis. White patients were prescribed more antidepressants than the BAME group (p < 0.001), with a significant effect size for comorbidities. The nature of the data source limited the ability to filter for short treatment durations as clinicians did not often record concrete medication end-dates in clinical note fields. There are significant differences in care pathways between ethnic groups in relation to TRD patients. It is vital to understand factors causing these potential clinical biases and increase awareness and education to deliver the most effective treatments for TRD in ethnic minority patients. • Major ethnic differences for Treatment Resistant Depression patients in the UK • Ethnic minority patients had shorter inpatient stays and more unplanned admissions • Potential clinical biases need to be addressed to enable best treatment pathways [ABSTRACT FROM AUTHOR]

Tardive dyskinesia (TD) is a movement disorder that can arise as a side efect of treatment with dopamine receptor-blocking agents (DRBAs), including antipsychotic drugs (APDs) used to manage psychotic illnesses. Second-generation APDs (SGAs) are often preferred to first-generation drugs due to their lower propensity to cause TD, however many SGAs-treated patients still develop the condition. Although TD is a global health concern, evidence regarding the occurrence of TD and how it is managed in Asian countries is currently limited. This article reports the results of a systematic review of the published literature on TD focusing on its prevalence, types of patients, knowledge of the condition, causative factors, and usual treatment pathways in clinical practice in Asian countries. Epidemiological data suggest that the prevalence of TD is increasing globally due to an overall rise in APD use, contributing factors being polypharmacy with multiple APDs, the use of higher than necessary doses, and off-label use for non-psychotic indications. Although exact prevalence figures for TD in Asian countries are difficult to define, there is a similar pattern of rising APD use which will result in increasing numbers of TD patients in this region. These issues need to be addressed and strategies developed to minimize TD risk and manage this disabling condition which impacts patients' quality of life and daily functioning. To date, both research into TD has been predominantly psychiatry focused and the perspectives from neurologists regarding the clinicalmanagement of this challenging condition are scarce. However, neurologists have an essential role inmanaging themovement disorders manifestations that characterize TD. Optimum management of TD, therefore, should ideally involve collaboration between psychiatrists and neurologists in joint care pathways, wherever practical. Collaborative pathways are proposed in this article, and the challenges that will need to be addressed in Asian countries to improve the care of people with TD are highlighted, with a focus on the neurologist's viewpoint and the implications for the management of TD globally. [ABSTRACT FROM AUTHOR]

Tardive dyskinesia (TD) is a movement disorder that can arise as a side effect of treatment with dopamine receptor-blocking agents (DRBAs), including antipsychotic drugs (APDs) used to manage psychotic illnesses. Second-generation APDs (SGAs) are often preferred to first-generation drugs due to their lower propensity to cause TD, however many SGAs-treated patients still develop the condition. Although TD is a global health concern, evidence regarding the occurrence of TD and how it is managed in Asian countries is currently limited. This article reports the results of a systematic review of the published literature on TD focusing on its prevalence, types of patients, knowledge of the condition, causative factors, and usual treatment pathways in clinical practice in Asian countries. Epidemiological data suggest that the prevalence of TD is increasing globally due to an overall rise in APD use, contributing factors being polypharmacy with multiple APDs, the use of higher than necessary doses, and off-label use for non-psychotic indications. Although exact prevalence figures for TD in Asian countries are difficult to define, there is a similar pattern of rising APD use which will result in increasing numbers of TD patients in this region. These issues need to be addressed and strategies developed to minimize TD risk and manage this disabling condition which impacts patients' quality of life and daily functioning. To date, both research into TD has been predominantly psychiatry focused and the perspectives from neurologists regarding the clinical management of this challenging condition are scarce. However, neurologists have an essential role in managing the movement disorders manifestations that characterize TD. Optimum management of TD, therefore, should ideally involve collaboration between psychiatrists and neurologists in joint care pathways, wherever practical. Collaborative pathways are proposed in this article, and the challenges that will need to be addressed in Asian countries to improve the care of people with TD are highlighted, with a focus on the neurologist's viewpoint and the implications for the management of TD globally.

Background and objectives: With the proliferation of real-world or observational health data, there is increasing interest in studying treatment trajectories. The real-life treatment trajectories can be complex, and one has to simplify the patterns to draw any conclusions; however, oversimplification will cause the loss of essential details. Thus, the visualization challenge is to strike a balance between the two extremes. Methods: We have implemented the observation of treatment trajectories starting from cohort definitions in cooperation with medical specialists, data processing, and then generating the interactive visualizations and detailed data tables derived from input data within an open-source R package as a Shiny dashboard. The created R package called TrajectoryViz (https://github.com/HealthInformaticsUT/TrajectoryViz) enables reproducible visual analysis and visual content generation for various data investigations and explanations. Results: We illustrate the use of the tool by assessing the sequence of events present within the data of cervical cancer prevention pathways, as well as the proportions of timely follow-up procedure events. Conclusion: Building a toolset to access, manage, and analyze observational health data enables more accessible visual analysis of complicated data, adding time dimension to otherwise simplified event sequences that make up trajectories.

Young people who engage in sexually abusive behaviour account for a substantial number of sexual offences worldwide. Despite this, a limited body of work has explored the optimal pathways into treatment for these young people. This is an important question to explore given the iatrogenic effects of receiving treatment following incarceration and burgeoning legislative frameworks focusing on the diversion of youth who sexually offend. In Victoria, Australia, Therapeutic Treatment Orders were introduced to mandate young people with sexually abusive behaviours to community-based treatment without undergoing formal criminal justice processes. It is possible this unique treatment pathway helps overcome several limitations associated with traditional pathways. This article reviews existing research on pathways to treatment for young people who engage in sexually abusive behaviour before detailing Therapeutic Treatment Orders, and the role they may play in unionising criminal justice and diversion treatment frameworks. Considerations for future research are also explored. [ABSTRACT FROM AUTHOR]

Background: Psychosis is known to have an adverse impact on an individual's quality of life, social and occupational functioning. A lack of treatment options for psychotic disorders such as schizophrenia contributes to adverse outcomes for individuals. A significant proportion of people with psychosis consult both formal and traditional routes of care. This warrants a need to explore perceptions around treatment options provided by diverse care providers, as the identification of avenues for support can improve psychiatric, alternative treatment and social outcomes. Methods: Focus groups discussions (FGDs) and in-depth interviews (IDIs) were used. Interactive Research and Development (IRD) research staff conducted 20 IDIs and 2 FGDs to obtain information about the perspectives, treatment pathways and experiences of individuals with psychosis, their caregivers, and service providers. Questions for clinician care providers and faith healers revolved around perceptions of psychosis, service users' background, subject knowledge and treatment, feedback and referral mechanisms, and promotion of services. A thematic analysis was used to analyze the interviews and coding was conducted on NVivo. Results: The results were categorized into five themes: perception of psychosis, experience of seeking/receiving care, assessment and diagnosis methods, promotion of services, and living with psychosis. Across service providers and patients, there was a wide variety of causes attributed to psychosis, and an overall lack of awareness regarding severe mental health conditions from both formal and informal care-providers. Biomedical treatment received mixed reviews, while some reported it as beneficial, the limited number of institutes and clinicians to cater for patients, stigma within society and care providers, the burden of caregiving, and misinformation from faith healers were all significant barriers to treatment. Conclusion: The results highlight the use of traditional healing practices for psychosis in Pakistan, which, coupled with inadequate referral mechanisms, present an opportunity to bridge the treatment gap between clinical and traditional healing practices through integration of treatment within community structures and systems. Better awareness of psychosis and its treatment methods, alongside interventions that reduce stigma could help facilitate help-seeking behavior and reduce the burden of caregiving. [ABSTRACT FROM AUTHOR]

Benign solid liver tumors are frequently discovered during routine sonographic examinations. As a rule, malignant tumors can be excluded using contrast medium-based sectional imaging; however, unclear cases can represent a diagnostic challenge. The category of solid benign liver tumors includes first and foremost hepatocellular adenoma (HCA), focal nodular hyperplasia (FNH) and hemangioma. Based on the most recent data, an overview of the current standards in the diagnostics and treatment is given. [ABSTRACT FROM AUTHOR]

Abstract Background The influence of healthcare system factors on treatment pathways for breast cancer has been studied extensively in lower-middle-income countries (LMICs), but in upper-middle-income countries (UMICs), this area is understudied. This article focuses on the experiences of breast cancer patients in Türkiye, a UMIC with a universal healthcare system. It explores variations in treatment pathways based on the type of health insurance provider (private or state). Methods The study uses an exploratory qualitative method based on in-depth interviews with 12 breast cancer patients. The inclusion criteria were Turkish nationality, female gender, and having received treatment from a private hospital within one year of the interview. A purposeful sampling strategy was employed to recruit patients who had either social health insurance only or who had private health insurance in addition to their social health insurance. A two-stage thematic analysis of the interview data was conducted. First, we examined whether the type of insurance provider makes a difference in treatment pathways; we then identified healthcare system factors that explain these differences. Results The study revealed two distinct pathways to treatment. These differ in terms of financial protection, service coverage, and patients’ sense of equity. Patients with private insurance reported easy access to timely and comprehensive treatment. Those without, however, had to navigate complicated routes to treatment; they generally had to resort to seeking treatment from more than one hospital. We found two healthcare system factors that explained the differences: a failure to fully enforce the mandates of the state’s social health insurance in the private hospital sector and growing reliance on private insurance to gain access to essential services. Conclusions Based on data from the Turkish case, we conclude that healthcare system factors are indeed influential in shaping treatment pathways for breast cancer in UMICs with universal healthcare. These factors include a failure to fully enforce the mandates of the state’s social health insurance programme in the private hospital sector and a growing reliance on private insurance to gain access to essential services. We note that this contrasts dramatically with the situation in LMICs, where the main factors are low-quality care and shortages of medical staff, medicines, and technologies.

Summary: Background and objectives: Psoriasis is a common skin disorder with a high physical and psychological burden for patients. Up to 30% of the patients are candidates for a systemic treatment. The aim of this study was to describe the characteristics and the real‐world systemic treatment of psoriasis patients. Patients and methods: This study was based on German medical claims data. A cross‐sectional analysis observed all psoriasis patients in 2020. A longitudinal analysis was conducted, addressing psoriasis patients who newly started a systemic treatment. Results: In total, 116,507 prevalent psoriasis patients and 13,449 newly treated patients were followed. Of all prevalent patients, 15.2% received systemic treatment in 2020 (8.7% systemic corticosteroids). Of the newly treated patients, 95.2% started with conventional treatment (79.2% systemic corticosteroids), 4.0% with biologics and 0.9% with apremilast. The rate of treatment discontinuation/switch after one year was highest for corticosteroids (91.3%) and lowest for biologics (23.1%). Conclusions: Around 15% of psoriasis patients in Germany received a systemic treatment, with > 50% of these prescribed systemic corticosteroids. Therefore, we conclude that systemic treatment is not in line with guideline recommendations in a substantial number of observed patients. The lowest discontinuation/switch rates for biologics support their wider use. [ABSTRACT FROM AUTHOR]

Copyright of Journal der Deutschen Dermatologischen Gesellschaft is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

In the era of evidence-based medicine, several clinical guidelines were developed, supporting cancer management from diagnosis to treatment and aiming to optimize patient care and hospital resources. Nevertheless, individual patient characteristics and organizational factors may lead to deviations from these standard recommendations during clinical practice. In this context, process mining in healthcare constitutes a valid tool to evaluate conformance of real treatment pathways, extracted from hospital data warehouses as event log, to standard clinical guidelines, translated into computer-interpretable formats. In this study we translate the European Society of Medical Oncology guidelines for rectal cancer treatment into a computer-interpretable format using Pseudo-Workflow formalism (PWF), a language already employed in pMineR software library for Process Mining in Healthcare. We investigate the adherence of a real-world cohort of rectal cancer patients treated at Fondazione Policlinico Universitario A. Gemelli IRCCS, data associated with cancer diagnosis and treatment are extracted from hospital databases in 453 patients diagnosed with rectal cancer. PWF enables the easy implementation of guidelines in a computer-interpretable format and visualizations that can improve understandability and interpretability of physicians. Results of the conformance checking analysis on our cohort identify a subgroup of patients receiving a long course treatment that deviates from guidelines due to a moderate increase in radiotherapy dose and an addition of oxaliplatin during chemotherapy treatment. This study demonstrates the importance of PWF to evaluate clinical guidelines adherence and to identify reasons of deviations during a treatment process in a real-world and multidisciplinary setting. [ABSTRACT FROM AUTHOR]

BackgroundPsychosis is known to have an adverse impact on an individual’s quality of life, social and occupational functioning. A lack of treatment options for psychotic disorders such as schizophrenia contributes to adverse outcomes for individuals. A significant proportion of people with psychosis consult both formal and traditional routes of care. This warrants a need to explore perceptions around treatment options provided by diverse care providers, as the identification of avenues for support can improve psychiatric, alternative treatment and social outcomes.MethodsFocus groups discussions (FGDs) and in-depth interviews (IDIs) were used. Interactive Research and Development (IRD) research staff conducted 20 IDIs and 2 FGDs to obtain information about the perspectives, treatment pathways and experiences of individuals with psychosis, their caregivers, and service providers. Questions for clinician care providers and faith healers revolved around perceptions of psychosis, service users’ background, subject knowledge and treatment, feedback and referral mechanisms, and promotion of services. A thematic analysis was used to analyze the interviews and coding was conducted on NVivo.ResultsThe results were categorized into five themes: perception of psychosis, experience of seeking/receiving care, assessment and diagnosis methods, promotion of services, and living with psychosis. Across service providers and patients, there was a wide variety of causes attributed to psychosis, and an overall lack of awareness regarding severe mental health conditions from both formal and informal care-providers. Biomedical treatment received mixed reviews, while some reported it as beneficial, the limited number of institutes and clinicians to cater for patients, stigma within society and care providers, the burden of caregiving, and misinformation from faith healers were all significant barriers to treatment.ConclusionThe results highlight the use of traditional healing practices for psychosis in Pakistan, which, coupled with inadequate referral mechanisms, present an opportunity to bridge the treatment gap between clinical and traditional healing practices through integration of treatment within community structures and systems. Better awareness of psychosis and its treatment methods, alongside interventions that reduce stigma could help facilitate help-seeking behavior and reduce the burden of caregiving.

Background: Thrombosis with thrombocytopenia syndrome (TTS) has been identified as a rare adverse event following some COVID-19 vaccines. Various guidelines have been issued on the treatment of TTS. We aimed to characterize the treatment of TTS and other thromboembolic events (venous thromboembolism (VTE), and arterial thromboembolism (ATE) after COVID-19 vaccination and compared to historical (pre-vaccination) data in Europe and the US. Methods: We conducted an international network cohort study using 8 primary care, outpatient, and inpatient databases from France, Germany, Netherlands, Spain, The United Kingdom, and The United States. We investigated treatment pathways after the diagnosis of TTS, VTE, or ATE for a pre-vaccination (background) cohort (01/2017—11/2020), and a vaccinated cohort of people followed for 28 days after a dose of any COVID-19 vaccine recorded from 12/2020 onwards). Results: Great variability was observed in the proportion of people treated (with any recommended therapy) across databases, both before and after vaccination. Most patients with TTS received heparins, platelet aggregation inhibitors, or direct Xa inhibitors. The majority of VTE patients (before and after vaccination) were first treated with heparins in inpatient settings and direct Xa inhibitors in outpatient settings. In ATE patients, treatments were also similar before and after vaccinations, with platelet aggregation inhibitors prescribed most frequently. Inpatient and claims data also showed substantial heparin use. Conclusion: TTS, VTE, and ATE after COVID-19 vaccination were treated similarly to background events. Heparin use post-vaccine TTS suggests most events were not identified as vaccine-induced thrombosis with thrombocytopenia by the treating clinicians. [ABSTRACT FROM AUTHOR]

Background: The influence of healthcare system factors on treatment pathways for breast cancer has been studied extensively in lower-middle-income countries (LMICs), but in upper-middle-income countries (UMICs), this area is understudied. This article focuses on the experiences of breast cancer patients in Türkiye, a UMIC with a universal healthcare system. It explores variations in treatment pathways based on the type of health insurance provider (private or state). Methods: The study uses an exploratory qualitative method based on in-depth interviews with 12 breast cancer patients. The inclusion criteria were Turkish nationality, female gender, and having received treatment from a private hospital within one year of the interview. A purposeful sampling strategy was employed to recruit patients who had either social health insurance only or who had private health insurance in addition to their social health insurance. A two-stage thematic analysis of the interview data was conducted. First, we examined whether the type of insurance provider makes a difference in treatment pathways; we then identified healthcare system factors that explain these differences. Results: The study revealed two distinct pathways to treatment. These differ in terms of financial protection, service coverage, and patients' sense of equity. Patients with private insurance reported easy access to timely and comprehensive treatment. Those without, however, had to navigate complicated routes to treatment; they generally had to resort to seeking treatment from more than one hospital. We found two healthcare system factors that explained the differences: a failure to fully enforce the mandates of the state's social health insurance in the private hospital sector and growing reliance on private insurance to gain access to essential services. Conclusions: Based on data from the Turkish case, we conclude that healthcare system factors are indeed influential in shaping treatment pathways for breast cancer in UMICs with universal healthcare. These factors include a failure to fully enforce the mandates of the state's social health insurance programme in the private hospital sector and a growing reliance on private insurance to gain access to essential services. We note that this contrasts dramatically with the situation in LMICs, where the main factors are low-quality care and shortages of medical staff, medicines, and technologies. [ABSTRACT FROM AUTHOR]

Abstract Objectives Colorectal cancer (CRC) is the second leading cause of cancer in Europe, with 1.931.590 people newly diagnosed in 2020. The purpose of this study is the investigation of treatment options and healthcare resource metastatic CRC (mCRC) in Greece. Methods This study is based on the information collected in November 2020 by an expert panel comprising of 6 medical oncologists from major public and private centers around Greece. A 3-round survey was undertaken, according to Delphi method. The treatment phases studied were: pre-progression; disease progression and terminal care. Pharmaceutical costs and resource utilization data were considered from the perspective of the Greek National Services Organization (EOPYY). RESULTS: Experts agreed that the anticipated prevalence of RAS mutation in mCRC is 47% (30% RAS/BRAF WT Left, 17% RAS/BRAF WT Right); 8% BRAF while, MSI-H/dMMR are found in 5% of mCRC tumors. Based on mutational status, 74.8% of patients receive biological targeted therapies in combination with fluoropyrimidine/based combination chemotherapy, as 1st line treatment, and 25.2% combination chemotherapy alone. At 2nd line, 58.6% of patients receive biological targeted therapies in combination with chemotherapy, 25.4% immunotherapy, 11% combination chemotherapy and 5% biological targeted therapies. At 3rd line 56% of patients receive combination chemotherapy, 28% biological targeted therapies, 10% biological targeted therapies in combination with chemotherapy and 6% immunotherapy. The weighted annual cost (pharmaceuticals and resource use cost) in 1st line per mCRC patient was calculated at €28,407, in 2nd line €33,568, in 3rd line €25,550. The annual cost beyond 3rd line per patient regardless mutation was €19,501 per mCRC patient. Conclusions mCRC is a societal challenge for healthcare systems as the treatment is more prolonged but expand patients’ survival. Thus, reimbursement decisions should be based not just on the cost of the treatment, but on the magnitude of the benefit of its treatment on patients’ survival and quality of life.

Background: Thrombosis with thrombocytopenia syndrome (TTS) has been identified as a rare adverse event following some COVID-19 vaccines. Various guidelines have been issued on the treatment of TTS. We aimed to characterize the treatment of TTS and other thromboembolic events (venous thromboembolism (VTE), and arterial thromboembolism (ATE) after COVID-19 vaccination and compared to historical (pre-vaccination) data in Europe and the US.Methods: We conducted an international network cohort study using 8 primary care, outpatient, and inpatient databases from France, Germany, Netherlands, Spain, The United Kingdom, and The United States. We investigated treatment pathways after the diagnosis of TTS, VTE, or ATE for a pre-vaccination (background) cohort (01/2017—11/2020), and a vaccinated cohort of people followed for 28 days after a dose of any COVID-19 vaccine recorded from 12/2020 onwards).Results: Great variability was observed in the proportion of people treated (with any recommended therapy) across databases, both before and after vaccination. Most patients with TTS received heparins, platelet aggregation inhibitors, or direct Xa inhibitors. The majority of VTE patients (before and after vaccination) were first treated with heparins in inpatient settings and direct Xa inhibitors in outpatient settings. In ATE patients, treatments were also similar before and after vaccinations, with platelet aggregation inhibitors prescribed most frequently. Inpatient and claims data also showed substantial heparin use.Conclusion: TTS, VTE, and ATE after COVID-19 vaccination were treated similarly to background events. Heparin use post-vaccine TTS suggests most events were not identified as vaccine-induced thrombosis with thrombocytopenia by the treating clinicians.

Background Meningitis causes significant mortality in regions with high comorbid HIV and TB. Improved outcomes are hindered by limited understanding of factors that delay adequate care. Methods In-depth interviews of patients admitted to the University Teaching Hospital with suspected meningitis, their caregivers, doctors and nurses were conducted. Patient/caregiver interviews explored meningitis understanding, treatment prior to admission and experiences since admission. Provider interviews addressed current and prior experiences with meningitis patients and hospital barriers to care. A conceptual framework based on the Three Delays Model identified factors that delayed care. Results Twenty-six patient/caregiver, eight doctor and eight nurse interviews occurred. Four delays were identified: in-home care; transportation to a health facility; clinic/first-level hospital care; and third-level hospital. Overcrowding and costly diagnostic testing delayed outpatient care; 23% of patients began with treatment inside the home due to prior negative experiences with biomedical care. Admission occurred after multiple clinic visits, where subsequent delays occurred during testing and treatment. Conclusions Delays in care from home to hospital impair quality meningitis care in Zambia. Interventions to improve outcomes must address patient, community and health systems factors. Patient/caregiver education regarding signs of meningitis and indications for care-seeking are warranted to reduce treatment delays. [ABSTRACT FROM AUTHOR]

Introduction: Approximately 15% of patients with non-small cell lung cancer (NSCLC) harbor an epidermal growth factor receptor mutation (EGFRm). Mutation testing (including EGFRm) is recommended for patients with advanced NSCLC (aNSCLC) prior to initiating first-line therapy (L1) or after progression on targeted therapy. To elucidate current and future unmet needs, the present study characterized real-world EGFR testing patterns and treatment patterns in patients with aNSCLC. Methods: This retrospective observational cohort study evaluated newly diagnosed adult patients with aNSCLC (stage IIIB or higher) from the Flatiron Health database. Eligible patients received at least L1 during 2015–2020 (testing cohorts) or 2011–2020 (treatment cohorts). Eligible patients for the treatment cohorts had an EGFR mutation. Results: The testing cohort included 22,726 patients, 75.5% had at least one EGFR test and 15.2% of those tested were positive for EGFR mutation. From 2015 to 2020, the median time from sample collection to test results decreased substantially while the proportion of NGS EGFR tests and use of plasma samples increased. The treatment cohort included 3701 patients (95% common mutations [cEGFR], 5.0% exon 20 insertions [ex20ins]). Three or more lines of therapy (LOTs) were observed in approximately 30% of patients. For L1, most cEGFR patients received EGFR tyrosine kinase inhibitors (EGFR-TKI, 68.1%) or platinum-based chemotherapy (PBC, 24.8%); most ex20ins patients received PBC (66.1%) or EGFR-TKI (17.5%). The most common L2 was EGFR-TKI (54.1%) or PBC (22.8%) for cEGFR and immunotherapy (25.9%) or PBC (25.9%) for ex20ins. No predominant L3 was evident in either group. Conclusion: This real-world study, among the largest analyses of testing patterns for patients with aNSCLC, demonstrates a comprehensive view of treatment patterns for patients with EGFR mutations, including ex20ins. Despite recent improvement, increased use of EGFR testing, including advanced methods, is needed to optimize treatment pathways and outcomes. Additionally, the lack of a predominant therapy in later lines indicates a need for new therapies. [ABSTRACT FROM AUTHOR]

Abstract Objectives Determine the proportion of patients starting the cochlear implant evaluation (CIE) process proceeding to cochlear implantation. Determine which patient factors are associated with undergoing cochlear implantation Methods Retrospective case series of all patients scheduled for a CIE within a tertiary academic neurotology practice between January 1, 2014 and April 30, 2016. Management pathways of patients undergoing CIE were examined. Results Two hundred thirty‐seven adult patients were scheduled for CIE during the study period. Two hundred twenty‐six patients started the evaluation process, and 203 patients completed full evaluation. Of patients that completed CIE, 166/203 (82%) met criteria for implantation and 37/203 (18%) did not meet criteria. Fifty‐nine patients out of 166 patients (36%) meeting criteria did not receive implants and 107/166 (64%) underwent implantation, yielding an overall implantation rate of 47% (107/226) among patients scheduled for CIE. Common reasons for deferring CI among candidates included failure to show up for preoperative appointment (24%), choosing hearing aids as an alternative (22%), patient refusal (21%) and insurance issues (17%). Overall, CIE led to a new adjunctive hearing device (CI or hearing aid) in 113 (113/203, 56%) cases. Conclusion Fifty‐six (113/203) percent of patients who underwent CIE at an academic medical center underwent CI surgery or received an adjunctive hearing device, but 36% (59/166) of candidates did not receive a CI. Patients who forewent CI despite meeting candidacy criteria did so due to cost/insurance issues, or due to preference for auditory amplification rather than CI. Level of evidence 4.

Observational research promises to complement experimental research by providing large, diverse populations that would be infeasible for an experiment. Observational research can test its own clinical hypotheses, and observational studies also can contribute to the design of experiments and inform the generalizability of experimental research. Understanding the diversity of populations and the variance in care is one component. In this study, the Observational Health Data Sciences and Informatics (OHDSI) collaboration created an international data network with 11 data sources from four countries, including electronic health records and administrative claims data on 250 million patients. All data were mapped to common data standards, patient privacy was maintained by using a distributed model, and results were aggregated centrally. Treatment pathways were elucidated for type 2 diabetes mellitus, hypertension, and depression. The pathways revealed that the world is moving toward more consistent therapy over time across diseases and across locations, but significant heterogeneity remains among sources, pointing to challenges in generalizing clinical trial results. Diabetes favored a single first-line medication, metformin, to a much greater extent than hypertension or depression. About 10% of diabetes and depression patients and almost 25% of hypertension patients followed a treatment pathway that was unique within the cohort. Aside from factors such as sample size and underlying population (academic medical center versus general population), electronic health records data and administrative claims data revealed similar results. Large-scale international observational research is feasible.

Objectives: Colorectal cancer (CRC) is the second leading cause of cancer in Europe, with 1.931.590 people newly diagnosed in 2020. The purpose of this study is the investigation of treatment options and healthcare resource metastatic CRC (mCRC) in Greece. Methods: This study is based on the information collected in November 2020 by an expert panel comprising of 6 medical oncologists from major public and private centers around Greece. A 3-round survey was undertaken, according to Delphi method. The treatment phases studied were: pre-progression; disease progression and terminal care. Pharmaceutical costs and resource utilization data were considered from the perspective of the Greek National Services Organization (EOPYY). RESULTS: Experts agreed that the anticipated prevalence of RAS mutation in mCRC is 47% (30% RAS/BRAF WT Left, 17% RAS/BRAF WT Right); 8% BRAF while, MSI-H/dMMR are found in 5% of mCRC tumors. Based on mutational status, 74.8% of patients receive biological targeted therapies in combination with fluoropyrimidine/based combination chemotherapy, as 1st line treatment, and 25.2% combination chemotherapy alone. At 2nd line, 58.6% of patients receive biological targeted therapies in combination with chemotherapy, 25.4% immunotherapy, 11% combination chemotherapy and 5% biological targeted therapies. At 3rd line 56% of patients receive combination chemotherapy, 28% biological targeted therapies, 10% biological targeted therapies in combination with chemotherapy and 6% immunotherapy. The weighted annual cost (pharmaceuticals and resource use cost) in 1st line per mCRC patient was calculated at €28,407, in 2nd line €33,568, in 3rd line €25,550. The annual cost beyond 3rd line per patient regardless mutation was €19,501 per mCRC patient. Conclusions: mCRC is a societal challenge for healthcare systems as the treatment is more prolonged but expand patients' survival. Thus, reimbursement decisions should be based not just on the cost of the treatment, but on the magnitude of the benefit of its treatment on patients' survival and quality of life. [ABSTRACT FROM AUTHOR]

This paper explores consumers' understanding and perception of the etiology of mental illness in community-based residential facilities in Ghana. Qualitative data involving in-depth interviews were used to collect data from 15 consumers of mental health services from two residential facilities. Thematic analysis was used to analyze the data. The study showed that mental illness is generally constructed within the medical and religious-cultural notion. The religious-cultural construction aligned mental illness to Ghanaian belief systems (supernatural forces, spirituality and traditional belief) and cultural practices (social norms and values) whilst the medical construction ascribed the etiology to biological, emotional and substance abuse issues. Although consumers had a positive perception of mental illness, they were doubtful about the presence of illness. The study concludes that the combination of medical, social and religious-cultural constructs and understanding of mental illness should be integrated into advocacy and awareness programmes to better educate consumers and clinicians. [ABSTRACT FROM AUTHOR]

Abstract Background Aim of the study was to find predictors of allocating patients after transcatheter aortic valve implantation (TAVI) to geriatric (GR) or cardiac rehabilitation (CR) and describe this new patient group based on a differentiated characterization. Methods From 10/2013 to 07/2015, 344 patients with an elective TAVI were consecutively enrolled in this prospective multicentric cohort study. Before intervention, sociodemographic parameters, echocardiographic data, comorbidities, 6-min walk distance (6MWD), quality of life and frailty (score indexing activities of daily living [ADL], cognition, nutrition and mobility) were documented. Out of these, predictors for assignment to CR or GR after TAVI were identified using a multivariable regression model. Results After TAVI, 249 patients (80.7 ± 5.1 years, 59.0% female) underwent CR (n = 198) or GR (n = 51). GR patients were older, less physically active and more often had a level of care, peripheral artery disease as well as a lower left ventricular ejection fraction. The groups also varied in 6MWD. Furthermore, individual components of frailty revealed prognostic impact: higher values in instrumental ADL reduced the probability for referral to GR (OR:0.49, p

Abstract Background The standard first- and second- line chemotherapy backbone regimens for metastatic colorectal cancer (mCRC) are 5-fluorouracil (5-FU)/capecitabine-based with addition of irinotecan or oxaliplatin. Until recently, evidence for optimal sequencing post second-line was sparse. Trifluridine/tipiracil (indicated for mCRC and gastric cancer after standard chemotherapies) was made available to UK patients via a named patient programme (NPP) before receiving marketing authorisation in Europe in 2016, allowing characterisation of UK treatment pathways, and evaluation of trifluridine/tipiracil in a UK non-trial population. Methods Data collected routinely for the NPP were analysed to describe the patient demographics, clinical characteristics and treatment pathways. Patients eligible for the programme were adults (≥18 years) with histologically or cytologically confirmed mCRC who had previously received chemotherapy treatment(s). Results Of the 250 eligible patients enrolled in the NPP, 194 patients received ≥1 dose of trifluridine/tipiracil and 56 patients did not receive trifluridine/tipiracil. The following results are reported first for patients who received trifluridine/tipiracil and second for those who did not receive trifluridine/tipiracil: median (IQR) age was 63.0 (54.0–69.0) and 62.0 (54.8–69.0) years; Eastern Cooperative Oncology Group performance status score was 0 for 28 and 14%, 1 for 65 and 70%, 2 for 7 and 16%. In terms of previous systemic treatments 47 and 43% had 2 prior lines of therapy. FOLFOX-, FOLFIRI- and CAPOX-based therapies were the most common first-line regimens in patients receiving trifluridine/tipiracil (37, 35 and 21%, respectively), and in patients not receiving trifluridine/tipiracil (41, 30 and 20%, respectively). Second-line treatment regimens in patients receiving and not receiving trifluridine/tipiracil were most commonly FOLFIRI-based (48 and 41%, respectively) and FOLFOX-based (19 and 21%, respectively). Patients received a median of 2 cycles of trifluridine/tipiracil with a median treatment duration of 1.8 (95% CI: 1.8–2.4) months. In patients who discontinued treatment due to disease progression, the median progression-free duration was 2.8 (95% CI: 2.4–2.9) months. Conclusions The results highlight the number of treatment pathways used to treat mCRC in routine UK clinical practice prior to the marketing authorisation and National Institute for Health and Care Excellence approval of trifluridine/tipiracil and highlight the lack of clinical guidelines for mCRC.

Background: Urinary stone disease affects 2–3% of the general population. Ureteric stones are associated with severe pain and can have a significant impact on a patient’s quality of life. Most ureteric stones are expected to pass spontaneously with supportive care; however, between one-fifth and one-third of patients require an active intervention. The two standard interventions are shockwave lithotripsy and ureteroscopic stone treatment. Both treatments are effective, but they differ in terms of invasiveness, anaesthetic requirement, treatment setting, number of procedures, complications, patient-reported outcomes and cost. There is uncertainty around which is the more clinically effective and cost-effective treatment. Objectives: To determine if shockwave lithotripsy is clinically effective and cost-effective compared with ureteroscopic stone treatment in adults with ureteric stones who are judged to require active intervention. Design: A pragmatic, multicentre, non-inferiority, randomised controlled trial of shockwave lithotripsy as a first-line treatment option compared with primary ureteroscopic stone treatment for ureteric stones. Setting: Urology departments in 25 NHS hospitals in the UK. Participants: Adults aged ≥ 16 years presenting with a single ureteric stone in any segment of the ureter, confirmed by computerised tomography, who were able to undergo either shockwave lithotripsy or ureteroscopic stone treatment and to complete trial procedures. Intervention: Eligible participants were randomised 1 : 1 to shockwave lithotripsy (up to two sessions) or ureteroscopic stone treatment. Main outcome measures: The primary clinical outcome measure was resolution of the stone episode (stone clearance), which was operationally defined as ‘no further intervention required to facilitate stone clearance’ up to 6 months from randomisation. This was determined from 8-week and 6-month case report forms and any additional hospital visit case report form that was completed by research staff. The primary economic outcome measure was the incremental cost per quality-adjusted life-year gained at 6 months from randomisation. We estimated costs from NHS resources and calculated quality-adjusted life-years from participant completion of the EuroQol-5 Dimensions, three-level version, at baseline, pre intervention, 1 week post intervention and 8 weeks and 6 months post randomisation. Results: In the shockwave lithotripsy arm, 67 out of 302 (22.2%) participants needed further treatment. In the ureteroscopic stone treatment arm, 31 out of 302 (10.3%) participants needed further treatment. The absolute risk difference was 11.4% (95% confidence interval 5.0% to 17.8%); the upper bound of the 95% confidence interval ruled out the prespecified margin of non-inferiority (which was 20%). The mean quality-adjusted life-year difference (shockwave lithotripsy vs. ureteroscopic stone treatment) was –0.021 (95% confidence interval 0.033 to –0.010) and the mean cost difference was –£809 (95% confidence interval –£1061 to –£551). The probability that shockwave lithotripsy is cost-effective is 79% at a threshold of society’s willingness to pay for a quality-adjusted life-year of £30,000. The CEAC is derived from the joint distribution of incremental costs and incremental effects. Most of the results fall in the south-west quadrant of the cost effectiveness plane as SWL always costs less but is less effective. Limitations: A limitation of the trial was low return and completion rates of patient questionnaires. The study was initially powered for 500 patients in each arm; however, the total number of patients recruited was only 307 and 306 patients in the ureteroscopic stone treatment and shockwave lithotripsy arms, respectively. Conclusions: Patients receiving shockwave lithotripsy needed more further interventions than those receiving primary ureteroscopic retrieval, although the overall costs for those receiving the shockwave treatment were lower. The absolute risk difference between the two clinical pathways (11.4%) was lower than expected and at a level that is acceptable to clinicians and patients. The shockwave lithotripsy pathway is more cost-effective in an NHS setting, but results in lower quality of life. Future work: (1) The generic health-related quality-of-life tools used in this study do not fully capture the impact of the various treatment pathways on patients. A condition-specific health-related quality-of-life tool should be developed. (2) Reporting of ureteric stone trials would benefit from agreement on a core outcome set that would ensure that future trials are easier to compare. Trial registration: This trial is registered as ISRCTN92289221. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 19. See the NIHR Journals Library website for further project information.

Background: Emerging moderately hypofractionated and ultra-hypofractionated schemes for radiotherapy (RT) of prostate cancer (PC) have resulted in various treatment options. The aim of this survey was to evaluate recent patterns of care of German-speaking radiation oncologists for RT of PC. Methods: We developed an online survey which we distributed via e‑mail to all registered members of the German Society of Radiation Oncology (DEGRO). The survey was completed by 109 participants between March 3 and April 3, 2020. For evaluation of radiation dose, we used the equivalent dose at fractionation of 2 Gy with α/β = 1.5 Gy, equivalent dose (EQD2 [1.5 Gy]). Results: Median EQD2(1.5 Gy) for definitive RT of the prostate is 77.60 Gy (range: 64.49–84.00) with median single doses (SD) of 2.00 Gy (range: 1.80–3.00), while for postoperative RT of the prostate bed, median EQD2(1.5 Gy) is 66.00 Gy (range: 60.00–74.00) with median SD of 2.00 Gy (range: 1.80–2.00). For definitive RT, the pelvic lymph nodes (LNs) are treated in case of suspect findings in imaging (82.6%) and/or according to risk formulas/tables (78.0%). In the postoperative setting, 78.9% use imaging and 78.0% use the postoperative tumor stage for LN irradiation. In the definitive and postoperative situation, LNs are irradiated with a median EQD2(1.5 Gy) of 47.52 Gy with a range of 42.43–66.00 and 41.76–62.79, respectively. Conclusion: German-speaking radiation oncologists' patterns of care for patients with PC are mainly in line with the published data and treatment recommendation guidelines. However, dose prescription is highly heterogenous for RT of the prostate/prostate bed, while the dose to the pelvic LNs is mainly consistent. [ABSTRACT FROM AUTHOR]

Introduction: Primary Sjögren's syndrome (pSS) is an autoimmune disease that affects salivary and lachrymal glands and is associated with complex extraglandular manifestations. This study investigates the clinical and economic burden and disease course of pSS in Sweden. Methods: This retrospective cohort study utilizes data from Swedish national registries and consists of patients at least 18 years of age diagnosed in secondary care with pSS, and matched members of the Swedish general population. Healthcare resource utilization (HRU) and costs were compared. The clinical burden of pSS during follow-up was explored via year-on-year prevalence of and time-to-first extraglandular manifestation. Employment status and retirement rates were used to investigate the impact of pSS on productivity. Results: A total of 8884 patients with pSS and 88,233 general population comparators were included. Patients with pSS had significantly higher rates of HRU and higher healthcare costs than matched comparators, including twice as many outpatient visits. Costs were highest in year 1 post index before reducing in years 2 and 3 and stabilizing thereafter. Almost two-thirds of patients received their index diagnosis during an outpatient visit, and < 30% of diagnoses were from rheumatology departments. Overall, 41% of patients experienced a healthcare encounter that included a relevant extraglandular manifestation code during follow-up. Patients with pSS had significantly higher odds of early retirement than the general population at 5 years post index. Conclusions: Patients with pSS experience a high clinical and economic disease burden in Sweden. Plain Language Summary: Primary Sjögren's syndrome (pSS) is an autoimmune disease that typically affects the secretory glands that produce tears, saliva, and other secretions. Patients can experience debilitating fatigue and can also develop conditions in other parts of the body, commonly including arthritis and Raynaud's phenomenon. This study investigated the burden and disease course of pSS in Sweden. Swedish national registry data were used to match adult patients diagnosed with pSS, with members of the Swedish general population. The use of healthcare resources and their associated costs were compared. The clinical burden of pSS during patient follow-up was explored via year-on-year occurrence and cumulative incidence of extraglandular symptoms. Employment and retirement rates were used to investigate the effect of pSS on patient productivity. A total of 8884 patients with pSS and 88,233 members of the general population were included in the study. Patients with pSS had higher use of healthcare resources and higher associated costs than members of the general population, including twice as many outpatient visits. Costs were highest in the first year after diagnosis, reducing and stabilizing over the following 7 years. Overall, 41% of patients had a healthcare encounter that included a relevant extraglandular symptom code during follow-up. Almost two-thirds of patients were diagnosed during an outpatient visit, and < 30% of diagnoses were from rheumatology departments. Patients with pSS were at a greater risk of early retirement than the general population at 5 years post-diagnosis. These results indicate that patients with pSS experience a high disease burden in Sweden. [ABSTRACT FROM AUTHOR]

Objectives PsA and AS are chronic diseases associated with significant morbidities. National and international management guidelines include treatment with biologic therapies to improve outcomes and quality of life. There are limited real-world data on the patients' journey from symptom onset to diagnosis and treatment in the UK. We use real-life, linked health data to explore patient pathways and the impact of biologics on patient outcomes. Methods Data from the Secure Anonymised Information Linkage databank in Wales were used to assess diagnosis and treatment of patients ≥18 years of age with at least one International Classification of Diseases, Tenth Revision code present for PsA/AS in rheumatology clinic data and at least one Read code present in primary care records. We investigated the use of biologics while exploring demographics, comorbidities and surgical procedures of 641 AS patients and 1312 PsA patients. Results AS patients were significantly younger at diagnosis and were predominantly male. The average time from presenting symptoms to diagnosis of AS and PsA was 7.9 (s. d. 5.5) and 9.3 (s. d. 5.5) years, respectively. The proportion of patients receiving biologic treatment was significantly higher in AS (46%) compared with PsA patients (28.8%); of these, 23.1% of AS and 22.2% of PsA patients stopped/switched a biologic. There was a significant reduction in primary care involvement, sick notes and disability living allowance for both AS and PsA patients following biologic initiation. Conclusion This real-world descriptive study confirms that patients treated with biologics have reduced disability and time off work despite being initiated ∼13 years after the first symptoms and 6 years after diagnosis. [ABSTRACT FROM AUTHOR]

Objectives: Determine the proportion of patients starting the cochlear implant evaluation (CIE) process proceeding to cochlear implantation.Determine which patient factors are associated with undergoing cochlear implantation Methods: Retrospective case series of all patients scheduled for a CIE within a tertiary academic neurotology practice between January 1, 2014 and April 30, 2016. Management pathways of patients undergoing CIE were examined. Results: Two hundred thirty‐seven adult patients were scheduled for CIE during the study period. Two hundred twenty‐six patients started the evaluation process, and 203 patients completed full evaluation. Of patients that completed CIE, 166/203 (82%) met criteria for implantation and 37/203 (18%) did not meet criteria. Fifty‐nine patients out of 166 patients (36%) meeting criteria did not receive implants and 107/166 (64%) underwent implantation, yielding an overall implantation rate of 47% (107/226) among patients scheduled for CIE. Common reasons for deferring CI among candidates included failure to show up for preoperative appointment (24%), choosing hearing aids as an alternative (22%), patient refusal (21%) and insurance issues (17%). Overall, CIE led to a new adjunctive hearing device (CI or hearing aid) in 113 (113/203, 56%) cases. Conclusion: Fifty‐six (113/203) percent of patients who underwent CIE at an academic medical center underwent CI surgery or received an adjunctive hearing device, but 36% (59/166) of candidates did not receive a CI. Patients who forewent CI despite meeting candidacy criteria did so due to cost/insurance issues, or due to preference for auditory amplification rather than CI. Level of evidence: 4. [ABSTRACT FROM AUTHOR]

Objective: The implementation of clinical quality indicators for monitoring cancer care in regional, rural and remote areas.Design: Retrospective data from a population-based Clinical Quality Registry for lung, colorectal and breast cancers.Setting: All major health services in the Barwon South Western region, Victoria, Australia.Participants: All patients who were diagnosed with cancer and who presented to a health service.Intervention(s): Clinical subgroups to review variations.Main Outcome Measures(s): Clinical quality indicators for lung, colorectal and breast cancers.Results: Clinical indicators included the following: discussion at multidisciplinary meetings, the timeliness of care provided and the type of care for different stages of the disease and survival outcomes. Many of the derived clinical indicator targets were reached. However, variations led to an improvement in the tumour stage being recorded in the medical record; an improved awareness of the need for adjuvant chemotherapy for colorectal cancer; a reduction in time to treatment for lung cancer and a reduced time to surgery for breast cancer, and the 30-day mortality post-treatment for all of the tumour streams was highlighted.Conclusions: Clinical quality indicators allow for valuable insights into patterns of care. These indicators are easily reproduced and may be of use to other cancer centres and health services. [ABSTRACT FROM AUTHOR]

Wilhelmine Meeraus,1 Robert Wood,2 Rafal Jakubanis,2 Tim Holbrook,2 Geoffray Bizouard,3 Johanna Despres,3 Camille Correia Da Silva,4 Gaelle Nachbaur,4 Sarah H Landis,1 Yogesh Punekar,5 Bernard Aguilaniu,6 Afisi S Ismaila7,8 1GlaxoSmithKline, Stockley Park West, Uxbridge, UK; 2Adelphi Real World, Bollington, Cheshire, UK; 3IQVIA, Paris, France; 4GlaxoSmithKline, Rueil-Malmaison, France; 5ViiV Healthcare, Brentford, Middlesex, UK; 6Faculty of Medicine, University Grenoble-Alpes, Grenoble, France; 7GlaxoSmithKline, Collegeville, PA, USA; 8Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada Background: Increasing availability of therapeutic options for COPD may drive new treatment pathways. This study describes COPD treatment in France, focusing on identifying initial treatment modifications in patients with COPD who either initiated long-acting bronchodilator (LABD)-based therapy or escalated to triple therapy (long-acting muscarinic antagonist [LAMA] + long-acting β2-agonist [LABA] + inhaled corticosteroid [ICS]). Methods: This retrospective analysis of patients with COPD in a large general practitioner database (IQVIA Longitudinal Patient Database) in France included two cohorts: Cohort 1 – new initiators of LABD-based therapy (LAMA, LABA, LAMA + LABA, LAMA + ICS, LABA + ICS or LAMA + LABA + ICS); Cohort 2 – patients escalating to triple therapy from mono- or dual-bronchodilator-based maintenance treatment. Both cohorts were indexed on the date of initiation/escalation (January 2008–December 2013), and the first treatment modification (at class level) within the 18-month post-index observational period was described. Five mutually exclusive outcomes were defined: continuous use (no modification), discontinuation (permanent [≥91 days with no restart] or temporary [≥91 days with subsequent restart]), switch, and augmentation (Cohort 1 only). Exploratory analysis of Cohort 1 explored potential drivers of treatment initiation. Results: Overall, 5,065 patients initiated LABD-based therapy (Cohort 1), and 501 escalated to triple therapy (Cohort 2). In Cohort 1, 7.0% of patients were continuous users, 46.5% discontinued permanently, 28.5% discontinued temporarily, 2.8% augmented (added LAMA and/or LABA and/or ICS), and 15.2% switched therapy. In Cohort 2, 18.2% of patients were continuous users, 7.2% discontinued permanently, 27.9% discontinued temporarily, and 46.7% switched therapy. Exploratory analyses showed that time since COPD diagnosis was first recorded, pre-index exacerbation events, and concomitant medical conditions were potential drivers of initial maintenance treatment choices. Conclusion: Discontinuation among new initiators of LABD-based therapy was high in France, whereas few switched or augmented treatment. In comparison, permanent discontinuation within 18 months was low in patients escalating to triple therapy. Keywords: triple therapy, France, treatment pathways, treatment modification, maintenance therapy

Venous leg ulcers (VLUs) are known to place a significant burden on healthcare services, with unhealed ulcers costing 135% more than their healed counterparts over the course of a year (Guest et al, 2016). This is a consequence of unwarranted variation in care attributed to difficulties experienced by nonspecialist clinicians caring for VLU in the community. VLU healing rates are relatively unknown, and national targets for healing do not yet exist, but there is evidence in the literature that specialist VLU services improve healing rates (Moffatt et al, 1992). Healogics is a specialist third party provider of VLU and lymphoedema services to the NHS, that takes a systematic approach to the assessment and management of these coexisting conditions. This paper presents the healing rates of 1015 people with VLU treated by Healogics for the full 65-month duration of an any qualified provider (AQP) contract. Healing rates of 86.14% were obtained in an average of 117 days in line with the published healing rates from other specialist leg ulcer services (Moffatt et al, 1992; Edwards et al, 2005). The healing rates reported in this paper demonstrate that a consistent, specialist approach to VLU management that is underpinned by best practice and national guidelines can help to achieve timely healing in the majority of patients, and can identify more complex patients for whom healing is not possible, enabling them to be placed on a maintenance pathway. The authors suggest that grading of VLUs according to complexity and data collection and analysis of healing rates could help to improve healing outcomes on a national level. [ABSTRACT FROM AUTHOR]

Background: Aim of the study was to find predictors of allocating patients after transcatheter aortic valve implantation (TAVI) to geriatric (GR) or cardiac rehabilitation (CR) and describe this new patient group based on a differentiated characterization.Methods: From 10/2013 to 07/2015, 344 patients with an elective TAVI were consecutively enrolled in this prospective multicentric cohort study. Before intervention, sociodemographic parameters, echocardiographic data, comorbidities, 6-min walk distance (6MWD), quality of life and frailty (score indexing activities of daily living [ADL], cognition, nutrition and mobility) were documented. Out of these, predictors for assignment to CR or GR after TAVI were identified using a multivariable regression model.Results: After TAVI, 249 patients (80.7 ± 5.1 years, 59.0% female) underwent CR (n = 198) or GR (n = 51). GR patients were older, less physically active and more often had a level of care, peripheral artery disease as well as a lower left ventricular ejection fraction. The groups also varied in 6MWD. Furthermore, individual components of frailty revealed prognostic impact: higher values in instrumental ADL reduced the probability for referral to GR (OR:0.49, p <  0.001), while an impaired mobility was positively associated with referral to GR (OR:3.97, p = 0.046). Clinical parameters like stroke (OR:0.19 of GR, p = 0.038) and the EuroSCORE (OR:1.04 of GR, p = 0.026) were also predictive.Conclusion: Advanced age patients after TAVI referred to CR or GR differ in several parameters and seem to be different patient groups with specific needs, e.g. regarding activities of daily living and mobility. Thus, our data prove the eligibility of both CR and GR settings. [ABSTRACT FROM AUTHOR]

Background: Although used for decades in psoriasis, access to phototherapy is becoming increasingly restricted. Besides patient inconvenience, this is in large part to do with a perception of "high cost." We previously reported a comprehensive analysis of direct and indirect phototherapy treatment cost. However, no robust data exist on the actual savings associated with providing phototherapy in the treatment pathway. Objectives: To quantify the cost savings achieved by phototherapy by delaying alternative treatments. Methods: Costs accruing through the UK‐wide established treatment pathway with and without phototherapy were analysed. Direct and indirectly incurred drug treatment costs were calculated using drug tariff, laboratory cost, estate rates and clinic review costs. To enhance reliability, ranges of cost scenarios were calculated by varying parameters such as drug dosing. Results: Medium annual cost savings per patient were £2200 [range: £1800‐£2900] for NB‐UVB, and £3700 [range: £2500‐£5300] if both NB‐UVB and PUVA courses were administered, respectively. As the provider treated 656 ± 76 patients per year during the 6‐year observational window, this amounted to savings of £Mio 2.4 [range: £Mio 1.6‐£Mio 3.4], even excluding additional non‐modelled drug‐associated costs (eg diagnostics, adverse event management). Since we only consider cost savings by delay of drug treatment for the duration of phototherapy, drug price reductions through biosimilar introduction only have a small effect. We provide spreadsheets allowing adaptation cost savings projections by varying input variables. Conclusions: Healthcare providers may achieve significant cost savings by implementing and/or widening access to phototherapy. [ABSTRACT FROM AUTHOR]

Background: The standard first- and second- line chemotherapy backbone regimens for metastatic colorectal cancer (mCRC) are 5-fluorouracil (5-FU)/capecitabine-based with addition of irinotecan or oxaliplatin. Until recently, evidence for optimal sequencing post second-line was sparse. Trifluridine/tipiracil (indicated for mCRC and gastric cancer after standard chemotherapies) was made available to UK patients via a named patient programme (NPP) before receiving marketing authorisation in Europe in 2016, allowing characterisation of UK treatment pathways, and evaluation of trifluridine/tipiracil in a UK non-trial population.Methods: Data collected routinely for the NPP were analysed to describe the patient demographics, clinical characteristics and treatment pathways. Patients eligible for the programme were adults (≥18 years) with histologically or cytologically confirmed mCRC who had previously received chemotherapy treatment(s).Results: Of the 250 eligible patients enrolled in the NPP, 194 patients received ≥1 dose of trifluridine/tipiracil and 56 patients did not receive trifluridine/tipiracil. The following results are reported first for patients who received trifluridine/tipiracil and second for those who did not receive trifluridine/tipiracil: median (IQR) age was 63.0 (54.0-69.0) and 62.0 (54.8-69.0) years; Eastern Cooperative Oncology Group performance status score was 0 for 28 and 14%, 1 for 65 and 70%, 2 for 7 and 16%. In terms of previous systemic treatments 47 and 43% had 2 prior lines of therapy. FOLFOX-, FOLFIRI- and CAPOX-based therapies were the most common first-line regimens in patients receiving trifluridine/tipiracil (37, 35 and 21%, respectively), and in patients not receiving trifluridine/tipiracil (41, 30 and 20%, respectively). Second-line treatment regimens in patients receiving and not receiving trifluridine/tipiracil were most commonly FOLFIRI-based (48 and 41%, respectively) and FOLFOX-based (19 and 21%, respectively). Patients received a median of 2 cycles of trifluridine/tipiracil with a median treatment duration of 1.8 (95% CI: 1.8-2.4) months. In patients who discontinued treatment due to disease progression, the median progression-free duration was 2.8 (95% CI: 2.4-2.9) months.Conclusions: The results highlight the number of treatment pathways used to treat mCRC in routine UK clinical practice prior to the marketing authorisation and National Institute for Health and Care Excellence approval of trifluridine/tipiracil and highlight the lack of clinical guidelines for mCRC. [ABSTRACT FROM AUTHOR]

Aim: Little is known regarding uptake of epithelial ovarian cancer (EOC) treatments or patient burden in UK real-world practice. Methods: Cross-sectional surveys of patients with advanced EOC and healthcare professionals (HCPs). Results: 101 HCPs and 142 patients participated. Time from initial primary care consultation to diagnosis was ∼7 weeks. 83% patients were offered hereditary genetic testing, with 89% uptake. 53% HCPs reported surgery was performed ≤1 month in non-neoadjuvant setting. Surgery delay negatively impacted patient quality of life (61%), mental health (89%), and surgical outcomes (63%). 56% patients received active first-line maintenance treatment; patients on active surveillance had greater emotional/psychological distress. Conclusion: Treatment delays and low uptake of active first-line treatment should be addressed. Emotional support must be readily accessible throughout treatment.

Background: The clinical pathways for treating mental illness have received global attention. Several empirical studies have been undertaken on treatment pathways in Ghana. No study, however, has systematically reviewed the literature related to the pathways of mental health treatment in Ghana. Aim: This article aims to identify the pathways used to treat mental illnesses; examine the evidence about the possibility of collaboration between biomedical, faith and traditional healing pathways; and draw attention to the barriers hindering such collaboration. Methods: A search of the published literature was conducted using Medline, Embase, PsycINFO, CINAHL (EBSCO), Web of Science and Scopus databases. The search was limited to the articles that were published in English and released between 2000 and June 2018. The review synthesises both qualitative and quantitative data. Results: The findings showed that mental illnesses in Ghana are treated using a mixture of biomedical and faith-based and traditional healing services. Faith and traditional healing pathways are typically used as a preliminary source of cultural assessment before seeking biomedical treatment. There is an increasing desire for collaboration between biomedical, faith and traditional healing pathways. However, several individual factors (attitude or stigma, the perceived efficacy of treatment and differences in the treatment process) and health system factors (a lack of policy and regulation, a limited number of biomedical service providers, limited financial support and geographical isolation of services) jointly contribute to barriers precluding establishing such collaboration. Conclusion: This review recommends that policies, regulations, educational support and financial incentives should be developed to facilitate collaboration between biomedical, faith and traditional healing service provision. [ABSTRACT FROM AUTHOR]

Copyright of Der Unfallchirurg is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Purpose: To explore factors influencing treatment pathways to mental health services among consumers in Ghana. Design and Methods: Cross‐sectional design using quantitative method. Findings: Treatment pathways for mental illness were general hospitals/clinics, psychiatric hospitals, and faith‐based practices. The predisposing (age, household size, primary occupation, ethnicity, marital status, religion, and geographic location, as well as attitudes and beliefs), enabling (affordability), and need factors (severity of mental illness) were significant predictors of treatment pathways. Practice Implications: Current advocacy and awareness for mental health services in Ghana should consider the predisposing, enabling, and need factors of consumers. Policy initiatives on mental health services should ensure adequate financing mechanisms and further establish collaboration between biomedical and faith‐based services. [ABSTRACT FROM AUTHOR]

The prevalence of chronic wounds in the Helsinki metropolitan area in 2008 was investigated. Thereafter, a specialised wound care team was founded as part of the City of Helsinki Health Services, aiming for early diagnoses of chronic wounds. In the current study, we have repeated the prevalence study to analyse the changes in the prevalence of chronic wounds. A questionnaire on wound patients was sent to all units of social and health care in the Helsinki metropolitan area. We asked about the number of patients with wounds treated during a 24‐hour period, as well the aetiology and location of the wounds. A total of 911 patients had, altogether, 1021 wounds. Thus, prevalence was 0.08%. Pressure and multifactorial ulcers were the most common aetiological groups, whereas wound without defined aetiology had diminished greatly (61%) The prevalence of chronic wound decreased when compared with 2008 (0.08% vs 0.1%). The number of elderly people aged over 65 years had increased 35%, and the age‐adjusted prevalence had decreased. Wounds are treated mostly in primary care units and as outpatients. Therefore, the following conclusion may be reached: diagnostic process and implementation of treatment paths are strengthened within primary care units, yet prevalence of wounds has decreased. [ABSTRACT FROM AUTHOR]

Copyright of Der Unfallchirurg is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Spinal cord stimulation (SCS) is a well-established treatment option in the multidisciplinary approach to chronic back and leg pain. Nevertheless, careful patient selection remains crucial to provide the most optimal treatment and prevent treatment failure. We report the protocol for the PROSTIM study, an ongoing prospective, multicentric and observational clinical study (NCT05349695) that aims to identify different patient clusters and their outcomes after SCS. Patients are recruited in different centers in Europe. Analysis focuses on identifying significant patient clusters based on different health domains and the changes in biopsychosocial variables 6 weeks, 3 and 12 months after implantation. This study is the first to include a biopsychosocial cluster analysis to identify significant patient groups and their response to treatment with SCS.

Plaque psoriasis affects approximately 2% to 3% of the global population, with psoriatic arthritis observed in approximately 20% to 30% of these individuals. Upon advances in research pathophysiology and treatment over the past decade, biologic therapies have been used more to treat moderate to severe psoriasis. In Canada, reimbursement bodies have defined prior authorization criteria to determine patient eligibility for funding of biologic treatments in moderate to severe plaque psoriasis. Generally, patients will have been treated with conventional therapies such as topical steroids, phototherapy, or systemic treatments such as methotrexate and cyclosporine before starting a biologic therapy. In difficult cases or severe flares in otherwise controlled disease, practitioners may augment the regimen with one or more conventional treatments. The objective of this observational report was to identify treatment pathways for psoriasis and psoriatic arthritis patients in Canada by examining initial biologic treatment and subsequent treatment optimization patterns for informed reimbursement discussions and decisions. A retrospective chart review was conducted at Newlab Clinical Research using medical records of patients who received at least 1 of 4 biologic agents approved at that time of the survey in Canada for the treatment of plaque psoriasis (adalimumab, etanercept, infliximab, ustekinumab). The study population consisted of patients who had moderate to severe plaque psoriasis, diagnosed by a dermatologist, for at least 6 months before the study index date and who attended Newlab Clinical Research between 2008 and 2013. All current and previous agents prescribed for the treatment of psoriasis were captured. A total of 248 patients with psoriasis treated with biologics were identified, of whom 27 (10.9%) were also diagnosed with psoriatic arthritis. Prior to initiating treatment with a biologic, most patients (72.1%) were treated with (or contraindicated to) methotrexate/cyclosporine. Treatment was supplemented with topical agents (70.6%) and/or followed by a course of ultraviolet light phototherapy (51.6%). Only 2.4% of patients were treated with a biologic first. Of 248 patients treated with biologics, almost half (47.6%) needed add-on therapy, whereas 16.5% of patients had an increase in dose or dosing interval. Furthermore, 14.1% of patients added a topical agent, 10.5% a topical steroid, or 6.5% a course of phototherapy while continuing biologic therapies. Finally, 30.4% of patients switched to another biologic treatment. Adalimumab was the most common agent used as a second-line agent (37.2%), and patients who started on adalimumab mainly switched to ustekinumab as a second-line agent (73.9%). Infliximab was the agent least often used as second-line therapy. [ABSTRACT FROM AUTHOR]