Journal of Health Policy and Outcomes Research

In recent years, haematologic treatment has undergone significant progress associated with the introduction of new drug technologies characterised by significant efficacy expressed by a deep response. At the same time the need for conducting and standardising MRD (minimal residual disease) evaluation, which can be used as an indicator for treatment discontinuation, is being debated. The aim of this paper is to indicate the significance of MRD in the assessment of treating CLL (chronic lymphocytic leukaemia) and discussing FTD (fixed time duration) treatment from a clinical and systemic perspective. Current evidence confirms that a negative end-of-treatment MRD status is a strong predictive factor for PFS (progression-free survival) and OS (overall survival) regardless of the type of first-line treatment used and the risk factors. Some new technologies used in CLL treatment (such as venetoclax) are characterised by very high efficacy and can lead to obtaining a deep response, and thus the possibility of using the treatment for a FTD. Obtaining MRD(-) means reducing the number of cancer cells, which decreases the risk of clonal resistance, and thus gives the patients a better prognosis. Administration of the most effective therapy at disease onset is particularly important in CLL treatment. It is underlined that the adopted therapeutic regimen can impact subsequent treatment lines. The greatest benefits of using highly efficacious therapies are reported in first-line treatment, which increases the chances of longer PFS and helps delay the use of subsequent treatment regimens. FTD therapies constitute a beneficial (clinical and systemic) perspective of CLL treatment.

Mariusz Kordecki

Monika Borowiack

Katarzyna Klaś

Journal of Health Policy & Outcomes Research

https://www.jhpor.com/article/2246-the-role-of-minimal-residual-disease-mrd-and-fixed-time-duration-ftd-on-the-example-of-venetoclax-in-chronic-lymphocytic-leukemia-cll---clinical-and-systemic-perspective#

慢性淋巴细胞白血病中维奈托克的最小残留病与固定时间治疗的作用——临床与系统性视角

In the context of the recently adopted law, teleconsultation is a new solution for mutual communication between the doctor and the patient. The introduced legal provisions are to improve contact with the doctor and his or her availability for the patient as a person in need of help. Such form of advice, or consultation is right now a health service provided by the doctor over distance using electronic communication channels (online, telephone). The epidemic safety means and the recommendations concerning caution in contacts with others during the ongoing COVID – 19 pandemic are key. The doctor, owing to the specific nature of the profession, is particularly exposed to the risk of infection from the patients or the places where he or she must stay. In order to counteract the COVID – 19 pandemic, new legislation has been introduced such as the Act of 2 March 2020 on special solutions related to preventing, counteracting and combating COVID-19, other infectious diseases and crisis situations caused by them and its later amendment of 31 March 2020, as well as the Regulation of the Minister Health of 12 August 2020 on the organizational standard of a teleconsultation within primary health care. The legal provisions included in these acts are related to the principles of providing health services by doctors in the form of a teleconsultation. The act determines and clarifies what a teleconsultation is, as a form of a mutual communication channel between the doctor and the patient, and the regulation applies to health services provided in this way within primary health care (POZ, family doctors), by POZ doctors. For the doctor, the changes introduced in the law are important, because they determine the new formula of providing health services, the way they are provided and the manner this fact is recorded in the medical documentation.

Rafał Patryn

Teleconsultation – Legal Aspects

远程会诊——法律方面

Introduction Atopic dermatitis (AD) is a commonly diagnosed inflammatory disease of the skin, with a chronic and relapsing course, which clinically manifests itself through eczematous skin lesions. The diagnosis is mainly based on the clinical picture of the disease. The goal of this project was to quantify the total population of AD patients in Poland and to make an attempt to determine the clinical profile of the population of patients who are moderately or severely affected by the disease. Methods The Economedica AD project consisted of two parts. The core part of the study, carried out among a representative group of specialists in dermatology and venereology, concerned the information collected from these specialists regarding both the overall health condition of the AD patients, treated by these doctors, as well as the treatment methods used for adult patients with a severe or moderate course of the disease. The second part of the study was an omnibus study, carried out on a representative group of adult Poles, and it mainly included questions concerning the potential presence of clinical AD symptoms. The combination of the two research methods allowed for an extrapolation of the collected data onto the total Polish patient population and to present detailed characteristics of AD patients in Poland. Results On the basis of the omnibus study, the total number of adult AD patients in Poland was estimated to be 705,718 (2.24% of adult Poles). 178,234 adult patients (0.6%), who in the past 12 months experienced a severe or moderate exacerbation of clinical AD symptoms, are currently in the care of dermatologists. Study population, i.e. patients with moderate or severe exacerbation of clinical condition, was also analysed in terms of general course of the disease. As a result of the analysis, estimated number of patients with mild AD was 18,560 (10% of the surveyed population); those with moderate AD: 113,264 (64% of this population), whilst 46,410 (26%) had severe AD. It should be noted that the estimates excluded patients who had only mild disease symptoms in 12 months prior to the study. In the case of 20% of severe AD patients, systemic cyclosporine therapy was initiated within the 12 months prior to the study, while 26% of patients received it within the last 24 months. An analysis of EASI or SCORAD indexes, measured for these two patient groups after the end of cyclosporin therapy, demonstrated the inefficacy of treatment for 47% and 34% of the patients respectively. Despite the clinical indications for such treatment, 54% of the patients underwent systemic cyclosporin therapy in neither of the two analysed periods, mainly due to the patient’s refusal (66%) or contraindications (24%) of the use of cyclosporine (according to the binding guidelines concerning cyclosporine therapy). Conclusions The prevalence of AD among Polish adults was estimated to be 2.24%. The results of the Economedica AD project with respect to the number of adult AD patients are similar to results of the studies carried out both in Poland and in other European countries. A detailed analysis of the subgroup of patients with a severe course of atopic dermatitis has shown a high percentage of patients for whom cyclosporin therapy turned out to be either ineffective (in 47% and 34% of patients treated with CsA in 12 and 24 months prior to the study) or intolerable; this was due to the patient’s refusal (about 66%) or contraindications connected with the patient’s health status or comorbidities (24%).

Karina Jahnz-Różyk

Magdalena Czarnecka-Operacz

Joanna Lis

Marta Polkowska

Katarzyna Wróbel

Anna Smaga

Stanisław Bogusławski

Stefan Bogusławski

Epidemiology of atopic dermatitis in Poland. Economedica AD

波兰特应性皮炎的流行病学。经济医学AD

Background: Moderate-to-severe plaque psoriasis (PsO) affects &gt;8 million Indians and has a detrimental effect on quality of life (QoL). Effective skin clearance can be one of the important factors for improving patient’s QoL. Newer biologics offer significant levels of skin clearance eventually improving QoL. However high cost of originator biologics is an impediment and poses a challenge for healthcare stakeholder to choose more efficacious and cost-effective biologic among the available options. Aims: To estimate the annual cost per responder (CPR) in PsO patients in India based on Psoriasis Area Severity Index (PASI)-75/90 for 52-weeks of treatment and estimate the number needed to treat (NNT). Methods: CPR has been developed to compare direct medical costs. The tool enables the user to input epidemiology numbers, level of drug usage and allows user to decide the biologic to choose to offer better health outcomes. Efficacy for biologics under evaluation were reported from the network meta-analysis and measured as proportion of patients achieving PASI-75/90 at week-52. NNT to obtain one patient with a PASI-75/90 response was henceforth calculated. Results: The tool demonstrates CPR and NNT results dynamically with user provided inputs. Additional number of responders who could potentially be treated with the biologic under consideration with the annual cost-savings generated were also presented. This will help users to assess comparative effectiveness of a biologic intervention by combining clinical and economic dimensions. Conclusion: This CPR tool supports evidence-based decision making for improved health outcomes in the Indian healthcare setting.

Sameer Gokhale

Sandeep Arora

Pallavi Kawatra

Cost per Responder Analysis of Biologics in Moderate-to-severe Plaque Psoriasis in Indian Healthcare Setting

印度医疗环境下中重度斑块型银屑病生物制剂的成本效益分析

Background: The aim was to study the results of the impact of thrombocytopenia on patients’ daily activities using the TSIDAV adapted to Ukrainian language. Methods: The assessment was performed using the TSIDAV vignette (thrombocytopenia Symptoms and their Impact on patients Daily Activities assessment Vignette), which was translated into Ukrainian language to obtain information on how the daily activities of adult patients with thrombocytopenia are affected by the disease symptoms. Patients (n=49) from one of the Lviv clinics participated in the study. The tool consists of two parts: first part identified the symptoms that cause particular concern to the patients; second part provides a self-assessment regarding the intensity of the specific symptoms influencing patients’ daily activities. The quantitative assessment was based on the Likert scale. Results: 49 patients with thrombocytopenia were interviewed. Bleeding episodes were of particular concern in case of the majority of the patients (22.4%). 30.6% of patients did not indicated any symptoms at all, 18.4% of respondents marked weakness and excessive tiredness. The most significant impact on the performance of daily activities, both for men, and for women, was related to “nose and /or gums bleeding” (40.0% of men and 29.2% of women). None of the respondents indicated “menstrual bleeding” as “significant impact” on their daily activities. Conclusion: The Ukrainian-language TSIDAV has confirmed its function as an instrument for assessing the impact of the thrombocytopenia symptoms on patients’ daily activities, it can be used for individualized support clinical and/or pharmaceutical intervention.

Olga Boretska

Yuliya Nastyukha

Lidiya Kaiser

Mariola Drozd

Evaluation of thrombocytopenia symptoms influence on patients' daily activities using TSIDAV adapted to Ukrainian language

评估血小板减少症状对患者日常活动的影响：基于乌克兰语适配的TSIDAV

Objectives: The aim of this study was to investigate the situation of patients with neovascular Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) in Poland, in terms of health needs and availability of treatment. Methods: We collected data on the epidemiology of both diseases from the literature, as well as statistical data and data on medical services provided obtained from the National Health Fund. Results: Based on available data, it is difficult to precisely estimate the actual number of patients with AMD and DME in Poland. In 2021, in Poland over 130 000 patients used any medical service settled according to the ICD-10 codes: H35.0, H35.8 or H36.0. About 26% with AMD and 19% with DME required hospitalization. Despite the fact that in recent years the number of patients in the Drug Program offering access to best therapeutic standards (aflibercept or ranibizumab, and then also with brolucizumab) has been increasing, it is still a small percentage of those who could be treated. Conclusions: The analysis of data regarding the implementation of the AMD and DME treatment program in Poland indicates a large untapped potential. Despite the existence of a possibly large number of patients only a small number receives treatment.

Michał Seweryn

Agnieszka Leszczyńska

Sławomir Teper

Potential in the treatment of neovascular Age-related Macular Degeneration and Diabetic Macular Edema in Poland. The population needs and access to therapy

波兰新生血管性年龄相关性黄斑变性和糖尿病性黄斑水肿治疗潜力：人口需求与治疗可及性

Objective. The aim of our study was to research the engagement and personal contribution to volunteering of pharmaceutical professionals and students in conditions of Russian-Ukrainian war. Methods. An anonymous online questionnaire-based survey was conducted among Ukrainian pharmaceutical professionals and students (n = 517; approximate response rate - 40%). The analyzed period was February-April 2023. Statistical analysis was performed using a spreadsheet Microsoft Excel. Results. The results of the questionnaire survey have shown that almost two thirds of respondents (63.45%) were engaged in volunteer activities. The most relevant sources of information about volunteering were pages, channels and groups of volunteer organizations in social networks (22.21% of responses), information from friends, colleagues, relatives, etc., related to volunteering (21.86%), various announcements in social networks (20.83%). Leaders among social networks were Telegram (28.32%), Instagram (28.05%) and Facebook (23.58%). The main motives for volunteering were the desire to help the army (43.57%) and internally displaced persons (25.73%), and the main forms of participation in volunteer activities were the collection of funds, clothes, household items, food and medicines (24.31%), transfer of funds for the needs of the army (17.36%) and for volunteer activities (17.26%). Conclusion. The role of volunteering in the conditions of the Russian-Ukrainian war among pharmacists and pharmaceutical students was studied and understood. Keywords: pharmacists, pharmacy students, volunteering, war, questionnaire survey.

Bohdan Hromovyk

Sofiia Shunkina

Yuliia Kremin

Ostap Pankevych

Volunteer activity of pharmacists and its role in the conditions of Russia's military aggression against Ukraine

药剂师志愿者活动及其在俄罗斯对乌克兰军事侵略条件下的作用

Edyta Skibińska

Robert Karaszewski

The Devastating Impact of Toxic Leadership on Health-Care Organizations

有毒领导对医疗机构的毁灭性影响

Background Despite the efforts of leading statistical authorities and experts worldwide, misuse of statistical significance remains a common, dangerous practice in public health research. There is an urgent need to quantify this phenomenon. Methods 200 studies were randomly selected within the PubMed database. An evaluation scale for the interpretation and presentation of statistical results (SRPS) was adopted. The maximum achievable score was 4 points. Abstracts (A) and full texts (FT) were compared to highlight any differences in presentation. The Wilcoxon signed-rank test was employed in this scope. Results All studies failed to adopt P-values as continuous measures of compatibility between the data and the target hypothesis as assessed by the chosen test. The vast majority did not provide information on the model specification. However, in most cases, all findings were reported in full within the manuscripts. The Wilcoxon signed-rank test showed a marked incompatibility of the null hypothesis of zero difference between A and FT scores with the data obtained in the survey: null P &lt; .001 (as assessed by the model), r = 0.87 (standardized effect size). Additionally, the score difference (207.5 points for A vs. 441.5 points for FT) indicates a scenario consistent with a substantial disparity in the completeness of the outcomes reporting. Conclusion These findings align with the hypothesis of widespread and severe shortcomings in the use and interpretation of statistical significance within public health research during 2023. Therefore, it is essential for academic journals to compulsorily demand higher scientific quality standards. The suggestions provided in this study could be helpful for this purpose.

Alessandro Rovetta

Statistical significance misuse in public health research: an investigation of the current situation and possible solutions

公共卫生研究中统计显著性误用的现状调查与可能解决方案

Purpose: Diabetes care, particularly type 2 diabetes (T2D), is recognised as a growing challenge in emergency situations. During the humanitarian crisis of war in Ukraine, it is important to focus on ensuring that patients have access to essential medicines for T2D. Since 1 April 2017, the Ministry of Health of Ukraine has been implementing the government programme "Affordable medicines". The List of reimbursed medicines necessary for the treatment of hypertension, diabetes and bronchial asthma includes 3 glucose lowering medicines (GLMs) - gliclazide, metformin, glibenclamide. From 01 April 2019, electronic prescribing has been implemented as part of the "Affordable Medicines" programme. It is important to investigate changes in the availability and affordability of GLMs for the treatment of T2D during the war and future directions in 2022-2023 in Ukraine. Methods: Information from the State Register of Medicinal Products of the Ministry of Health of Ukraine from March 2023 and February 2022 (before the start of the war) was the subject of the study. Marketing, analytical, graphical, generalisation analyses were applied. Analysis of the cost of 1 DDD GLM according to the WHO ATC/DDD index and solvency ratio analysis were applied. Results: This study is based on actual data from before the war in Ukraine and now shows that the affordability and availability of GLMs during the war in 2022-2023 has not changed dramatically. The 'Affordable Medicines' program was stably implemented, with €111.9 million allocated in 2023 and within 6 months of 2023. The National Health Service of Ukraine reimbursed €42.8 million to pharmacies for the Reimbursement List. Most Ukrainian manufacturers and foreign GLMs are very affordable due to the reimbursement system. From October 2023, 23 names of test stripes were included in the Reimbursement list of the "Affordable medicines" programme. However, foreign GLMs of innovative groups are moderately affordable for the working population based on the calculated solvency ratio. Conclusions: Our study revealed that despite the challenges of war, the healthcare system in Ukraine remains robust, particularly in ensuring stable access to pharmaceuticals for diabetes treatment. The "Affordable Medicines" programme and the Reimbursement List are updated twice a year, and the introduction of the new drugs for T2D and diabetes insipidus was completed in 2022. Thus, the innovative GLMs, despite being registered on the market in 2022, such as Semaglutide, Semaglutide and Dapagliflozin, are not affordable in 2023. A prospective trend is the inclusion of innovative GLMs for diabetes better care on the reimbursement list.

Iryna Vlasenko

Olha Zaliska

Lena Davitan

Comparative analysis of availability and affordability of hypoglycaemic medicines for Ukrainian patients during the war 2022-2023

2022-2023年乌克兰战争期间糖尿病药物的可获得性和可负担性比较分析

Publication Information	Publisher: Pro Medicina Foundation，Publishing cycle: ，Journal Type: journal，Open Access Journals: Yes
Basic data	Year of publication: 2019，Proportion of original research papers: 0.00%，Self Citation Rate:N.A.， Gold OA Rate: 0.00%
Average review cycle	网友分享经验：5 Weeks

Journal of Health Policy and Outcomes Research

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