Pub Date : 2023-08-25DOI: 10.1016/j.jcpo.2023.100438
Alessandro Bozzao , Damien Weber , Simon Crompton, Graça Braz, Dégi Csaba, Frederic Dhermain, Gaetano Finocchiaro, Thomas Flannery, Christof Kramm, Ian Law, Gianluca Marucci, Kathy Oliver, Christoph Ostgathe, Rosina Paterra, Gianfranco Pesce, Marion Smits, Riccardo Soffietti, Robert Terkola, Colin Watts, Alberto Costa, Philip Poortmans
European Cancer Organisation Essential Requirements for Quality Cancer Care (ERQCCs) are explanations of the organisation and actions necessary to provide high-quality care to patients with a specific cancer type. They are compiled by a working group of European experts representing disciplines involved in cancer care, and provide oncology teams, patients, policymakers and managers with an overview of the essential requirements in any healthcare system. The focus here is on adult glioma. Gliomas make up approximately 80% of all primary malignant brain tumours. They are highly diverse and patients can face a unique cognitive, physical and psychosocial burden, so personalised treatments and support are essential. However, management of gliomas is currently very heterogeneous across Europe and there are only few formally-designated comprehensive cancer centres with brain tumour programmes. To address this, the ERQCC glioma expert group proposes frameworks and recommendations for high quality care, from diagnosis to treatment and survivorship. Wherever possible, glioma patients should be treated from diagnosis onwards in high volume neurosurgical or neuro-oncology centres. Multidisciplinary team working and collaboration is essential if patients’ length and quality of life are to be optimised.
{"title":"European Cancer Organisation Essential Requirements for Quality Cancer Care: Adult glioma","authors":"Alessandro Bozzao , Damien Weber , Simon Crompton, Graça Braz, Dégi Csaba, Frederic Dhermain, Gaetano Finocchiaro, Thomas Flannery, Christof Kramm, Ian Law, Gianluca Marucci, Kathy Oliver, Christoph Ostgathe, Rosina Paterra, Gianfranco Pesce, Marion Smits, Riccardo Soffietti, Robert Terkola, Colin Watts, Alberto Costa, Philip Poortmans","doi":"10.1016/j.jcpo.2023.100438","DOIUrl":"10.1016/j.jcpo.2023.100438","url":null,"abstract":"<div><p>European Cancer Organisation Essential Requirements for Quality Cancer Care (ERQCCs) are explanations of the organisation and actions necessary to provide high-quality care to patients with a specific cancer type. They are compiled by a working group of European experts representing disciplines involved in cancer care, and provide oncology teams, patients, policymakers and managers with an overview of the essential requirements in any healthcare system. The focus here is on adult glioma. Gliomas make up approximately 80% of all primary malignant brain tumours. They are highly diverse and patients can face a unique cognitive, physical and psychosocial burden, so personalised treatments and support are essential. However, management of gliomas is currently very heterogeneous across Europe and there are only few formally-designated comprehensive cancer centres with brain tumour programmes. To address this, the ERQCC glioma expert group proposes frameworks and recommendations for high quality care, from diagnosis to treatment and survivorship. Wherever possible, glioma patients should be treated from diagnosis onwards in high volume neurosurgical or neuro-oncology centres. Multidisciplinary team working and collaboration is essential if patients’ length and quality of life are to be optimised.</p></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"38 ","pages":"Article 100438"},"PeriodicalIF":1.3,"publicationDate":"2023-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10577179","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-08-25DOI: 10.1016/j.jcpo.2023.100440
Alkesh Patel , Francesco Perrone , Darren M. Ashcroft , Nicola Flaum , Natalie Cook , Silvia Riva
Background
This study aimed to develop a British version of the Patient Reported Outcomes for Fighting Financial Toxicity of Cancer (PROFFIT): originally designed to measure financial toxicity in cancer for an Italian universal healthcare system. The instrument was carefully evaluated for crosscultural equivalence, face validity and practicality.
Methods
A systematic approach to cross-cultural adaptation was used, including forward translation, synthesis, backward translation, consolidation of translations with an expert committee, and cognitive interviews. As part of the cognitive interview process, 18 cancer patients completed a structured interview of 60–90 min in length.
Results
The translated and modified PROFFIT questionnaire demonstrated good psycho-linguistic properties, including high compliance (only one item was revised for clarity), high retrieval from memory, high decision-making processes, and high response processes.
Conclusion
PROFFIT has been found to be functional and adaptable in a new social environment. The tool may be useful for tailoring interventions to address and measure financial hardships within the cancer population, which appear to be a current challenge for public health.
Policy summary
Even in universal healthcare systems, financial toxicity due to the increase in outof-pocket expenses poses a significant problem. The FT phenomenon warrants proper attention in the United Kingdom since it may negatively impact financial well-being, quality of life, psychosocial health, and treatment adherence.
{"title":"Cross-cultural adaptation of the PROFFIT Instrument to measure financial toxicity in people living with cancer within a UK population","authors":"Alkesh Patel , Francesco Perrone , Darren M. Ashcroft , Nicola Flaum , Natalie Cook , Silvia Riva","doi":"10.1016/j.jcpo.2023.100440","DOIUrl":"10.1016/j.jcpo.2023.100440","url":null,"abstract":"<div><h3>Background</h3><p>This study aimed to develop a British version of the Patient Reported Outcomes for Fighting Financial Toxicity of Cancer (PROFFIT): originally designed to measure financial toxicity in cancer for an Italian universal healthcare system. The instrument was carefully evaluated for crosscultural equivalence, face validity and practicality.</p></div><div><h3>Methods</h3><p>A systematic approach to cross-cultural adaptation was used, including forward translation, synthesis, backward translation, consolidation of translations with an expert committee, and cognitive interviews. As part of the cognitive interview process, 18 cancer patients completed a structured interview of 60–90 min in length.</p></div><div><h3>Results</h3><p>The translated and modified PROFFIT questionnaire demonstrated good psycho-linguistic properties, including high compliance (only one item was revised for clarity), high retrieval from memory, high decision-making processes, and high response processes.</p></div><div><h3>Conclusion</h3><p>PROFFIT has been found to be functional and adaptable in a new social environment. The tool may be useful for tailoring interventions to address and measure financial hardships within the cancer population, which appear to be a current challenge for public health.</p></div><div><h3>Policy summary</h3><p>Even in universal healthcare systems, financial toxicity due to the increase in outof-pocket expenses poses a significant problem. The FT phenomenon warrants proper attention in the United Kingdom since it may negatively impact financial well-being, quality of life, psychosocial health, and treatment adherence.</p></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"38 ","pages":"Article 100440"},"PeriodicalIF":1.3,"publicationDate":"2023-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10522990","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-08-24DOI: 10.1016/j.jcpo.2023.100437
Sonia Maria da Silva , João Emilio Peixoto , Flávia Engel Aduan , Linei Augusta Urban , Leonardo Vieira Travassos , Ellyete Oliveira Canella , Salete Fonseca Rego , Alex Camara Campos , Anna Maria Araújo , Marcela Brisighelli Schaefer , Ana Lucia Kefalas , José Luis Francisco , Norma Medicis Maranhão , Radiá Pereira dos Santos , Selma di Pace Bauab , José Michel Kalaf , Luciano Fernades Chala , Henrique Lima Couto , Rosangela Requi Jakubiak , Gabriel Wingler Tinoco
Background
This study aims to provide an academic medical overview of the framework and key outcomes of two mammography quality certification programs in Brazil.
Methods
These programs assess radiation dose and phantom image quality in mammography units through a postal system. Each unit that passes this initial assessment is required to submit a sample of copies of five complete examinations. The quality of the patient images and reports is then reviewed by radiologists and medical physicist experts. Additionally, the number of mammography units and mammography coverage in the target population, were assessed.
Results
During the study period, 1007 units applied to the certification programs, and 934 (92.8%) successfully passed the assessment of radiation dose and phantom image quality. Out of these, 556 (59.5%) also passed the review of clinical image quality and reports, earning certification. The main issues related to mammogram and report quality were associated with the performance of radiographers (in terms of positioning) and radiologists (in terms of interpretation). On average, there are more than two mammography units/10,000 women in the target group. The screening mammography coverage in this group is 26.3% for women relying exclusively on the public healthcare and 58.1% for women with private healthcare plans.
Conclusion
This study demonstrates the suitability of the framework adopted by national mammography quality certification programs in a middle-income country. These programs are carried out by relatively small workforce and at reasonable costs, utilizing postal resources to cover the large number of existing mammographic units and the vast distances within the country.
Policy statement
All mammography services in Brazil must adhere to the quality requirements for examinations and reference values for radiation dose to women established by the Ministry of Health. This ensures standardized conditions for early detection of breast cancer and minimizes the risk associated with x-rays.
{"title":"Two national mammography quality certification programs in Brazil: Framework and main outcomes between 2017 and 2021","authors":"Sonia Maria da Silva , João Emilio Peixoto , Flávia Engel Aduan , Linei Augusta Urban , Leonardo Vieira Travassos , Ellyete Oliveira Canella , Salete Fonseca Rego , Alex Camara Campos , Anna Maria Araújo , Marcela Brisighelli Schaefer , Ana Lucia Kefalas , José Luis Francisco , Norma Medicis Maranhão , Radiá Pereira dos Santos , Selma di Pace Bauab , José Michel Kalaf , Luciano Fernades Chala , Henrique Lima Couto , Rosangela Requi Jakubiak , Gabriel Wingler Tinoco","doi":"10.1016/j.jcpo.2023.100437","DOIUrl":"10.1016/j.jcpo.2023.100437","url":null,"abstract":"<div><h3>Background</h3><p>This study aims to provide an academic medical overview of the framework and key outcomes of two mammography quality certification programs in Brazil.</p></div><div><h3>Methods</h3><p>These programs assess radiation dose and phantom image quality in mammography units through a postal system. Each unit that passes this initial assessment is required to submit a sample of copies of five complete examinations. The quality of the patient images and reports is then reviewed by radiologists and medical physicist experts. Additionally, the number of mammography units and mammography coverage in the target population, were assessed.</p></div><div><h3>Results</h3><p>During the study period, 1007 units applied to the certification programs, and 934 (92.8%) successfully passed the assessment of radiation dose and phantom image quality. Out of these, 556 (59.5%) also passed the review of clinical image quality and reports, earning certification. The main issues related to mammogram and report quality were associated with the performance of radiographers (in terms of positioning) and radiologists (in terms of interpretation). On average, there are more than two mammography units/10,000 women in the target group. The screening mammography coverage in this group is 26.3% for women relying exclusively on the public healthcare and 58.1% for women with private healthcare plans.</p></div><div><h3>Conclusion</h3><p>This study demonstrates the suitability of the framework adopted by national mammography quality certification programs in a middle-income country. These programs are carried out by relatively small workforce and at reasonable costs, utilizing postal resources to cover the large number of existing mammographic units and the vast distances within the country.</p></div><div><h3>P<strong>olicy statement</strong></h3><p>All mammography services in Brazil must adhere to the quality requirements for examinations and reference values for radiation dose to women established by the Ministry of Health. This ensures standardized conditions for early detection of breast cancer and minimizes the risk associated with x-rays.</p></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"38 ","pages":"Article 100437"},"PeriodicalIF":1.3,"publicationDate":"2023-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10158647","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-08-21DOI: 10.1016/j.jcpo.2023.100439
Gwen M.L. Sys
{"title":"Playing the infinite in sarcoma care and research","authors":"Gwen M.L. Sys","doi":"10.1016/j.jcpo.2023.100439","DOIUrl":"10.1016/j.jcpo.2023.100439","url":null,"abstract":"","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"38 ","pages":"Article 100439"},"PeriodicalIF":1.3,"publicationDate":"2023-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10430051","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-08-19DOI: 10.1016/j.jcpo.2023.100443
Naser Mohamadkhani , Azin Nahvijou , Mohammad Hadian
Background
Prostate Cancer screening should be discontinued at older ages because competing mortality risks eventually dominate the risk of Prostate Cancer and harms exceed benefits. We explored the Prostate Cancer screening stopping age from the patient, healthcare system, and social perspectives in Iran.
Methods
We applied Bellman Equations to formulate the net benefits biopsy and “do nothing”. Using difference between the net benefits of two alternatives, we calculated the stopping age. The cancer states were without cancer, undetected cancer, detected cancer, metastatic cancer, and death. To move between states, we applied Markov property. Transition probabilities, rewards, and costs were inferred from the medical literature. The base-case scenario estimated the stopping age from the patient, healthcare system, and social perspectives. A one-way sensitivity used to find the most influential parameters on the stopping age.
Results
Our results suggested that Prostate Cancer screening stopping ages from the patient, healthcare system, and social were 70, 68, and 68 respectively. The univariate sensitivity analysis showed that the stopping ages were sensitive to the disutility of treatment, discount factor, the disutility of metastasis, the annual probability of death from other causes, and the annual probability of developing metastasis from the hidden cancer state.
Conclusions
Men should not be screened for Prostate Cancer beyond 70 years old, as this results in the net benefit of "do nothing" above the biopsy. Nevertheless, this finding needs to be further studied with more detailed cancer progression models (considering re-biopsy, comorbidities, and more complicated states transition) and using local utility and willingness to pay value information.
{"title":"Optimal age to stop prostate cancer screening and early detection","authors":"Naser Mohamadkhani , Azin Nahvijou , Mohammad Hadian","doi":"10.1016/j.jcpo.2023.100443","DOIUrl":"10.1016/j.jcpo.2023.100443","url":null,"abstract":"<div><h3>Background</h3><p>Prostate Cancer screening should be discontinued at older ages because competing mortality risks eventually dominate the risk of Prostate Cancer and harms exceed benefits. We explored the Prostate Cancer screening stopping age from the patient, healthcare system, and social perspectives in Iran.</p></div><div><h3>Methods</h3><p>We applied Bellman Equations to formulate the net benefits biopsy and “do nothing”. Using difference between the net benefits of two alternatives, we calculated the stopping age. The cancer states were without cancer, undetected cancer, detected cancer, metastatic cancer, and death. To move between states, we applied Markov property. Transition probabilities, rewards, and costs were inferred from the medical literature. The base-case scenario estimated the stopping age from the patient, healthcare system, and social perspectives. A one-way sensitivity used to find the most influential parameters on the stopping age.</p></div><div><h3>Results</h3><p>Our results suggested that Prostate Cancer screening stopping ages from the patient, healthcare system, and social were 70, 68, and 68 respectively. The univariate sensitivity analysis showed that the stopping ages were sensitive to the disutility of treatment, discount factor, the disutility of metastasis, the annual probability of death from other causes, and the annual probability of developing metastasis from the hidden cancer state.</p></div><div><h3>Conclusions</h3><p>Men should not be screened for Prostate Cancer beyond 70 years old, as this results in the net benefit of \"do nothing\" above the biopsy. Nevertheless, this finding needs to be further studied with more detailed cancer progression models (considering re-biopsy, comorbidities, and more complicated states transition) and using local utility and willingness to pay value information.</p></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"38 ","pages":"Article 100443"},"PeriodicalIF":1.3,"publicationDate":"2023-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10031935","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-08-05DOI: 10.1016/j.jcpo.2023.100436
Ariana Znaor , Anton Ryzhov , María Lasierra Losada , Andre Carvalho , Vitaly Smelov , Anton Barchuk , Mikhail Valkov , Elena Ten , Diana Andreasyan , Saba Zhizhilashvili , Zaure Dushimova , Lilia D. Zhuikova , Alla Egorova , Alesya Yaumenenka , Sayde Djanklich , Orest Tril , Freddie Bray , Marilys Corbex
Background
Eastern Europe and Central Asia (EECA) countries have higher cervical and breast cancer mortality rates and later stage at diagnosis compared with the rest of WHO European Region. The aim was to explore current early detection practices including “dispensarization” for breast and cervix cancer in the region.
Methods
A questionnaire survey on early detection practices for breast and cervix cancer was sent to collaborators in 11 countries, differentiating services in the primary health setting, and population-based programs. Responses were received from Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, the Russian Federation (Arkhangelsk, Samara and Tomsk regions), Tajikistan, Ukraine, and Uzbekistan.
Results
All countries but Georgia, Kyrgyzstan, and the Russian Federation had opportunistic screening by clinical breast exam within “dispensarization” program. Mammography screening programs, commonly starting from age 40, were introduced or piloted in eight of nine countries, organized at national oncology or screening centres in Armenia, Belarus and Georgia, and within primary care in others. Six countries had “dispensarization” program for cervix cancer, mostly starting from the age 18, with smears stained either by Romanowsky-Giemsa alone (Belarus, Tajikistan and Ukraine), or alternating with Papanicolaou (Kazakhstan and the Russian Federation). In parallel, screening programs using Papanicolaou or HPV test were introduced in seven countries and organized within primary care.
Conclusion
Our study documents that parallel screening systems for both breast and cervix cancers, as well as departures from evidence-based practices are widespread across the EECA. Within the framework of the WHO Initiatives, existing opportunistic screening should be replaced by population-based programs that include quality assurance and control.
{"title":"Breast and cervical cancer screening practices in nine countries of Eastern Europe and Central Asia: A population-based survey","authors":"Ariana Znaor , Anton Ryzhov , María Lasierra Losada , Andre Carvalho , Vitaly Smelov , Anton Barchuk , Mikhail Valkov , Elena Ten , Diana Andreasyan , Saba Zhizhilashvili , Zaure Dushimova , Lilia D. Zhuikova , Alla Egorova , Alesya Yaumenenka , Sayde Djanklich , Orest Tril , Freddie Bray , Marilys Corbex","doi":"10.1016/j.jcpo.2023.100436","DOIUrl":"10.1016/j.jcpo.2023.100436","url":null,"abstract":"<div><h3>Background</h3><p>Eastern Europe and Central Asia (EECA) countries have higher cervical and breast cancer mortality rates and later stage at diagnosis compared with the rest of WHO European Region. The aim was to explore current early detection practices including “dispensarization” for breast and cervix cancer in the region.</p></div><div><h3>Methods</h3><p>A questionnaire survey on early detection practices for breast and cervix cancer was sent to collaborators in 11 countries, differentiating services in the primary health setting, and population-based programs. Responses were received from Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, the Russian Federation (Arkhangelsk, Samara and Tomsk regions), Tajikistan, Ukraine, and Uzbekistan.</p></div><div><h3>Results</h3><p>All countries but Georgia, Kyrgyzstan, and the Russian Federation had opportunistic screening by clinical breast exam within “dispensarization” program. Mammography screening programs, commonly starting from age 40, were introduced or piloted in eight of nine countries, organized at national oncology or screening centres in Armenia, Belarus and Georgia, and within primary care in others. Six countries had “dispensarization” program for cervix cancer, mostly starting from the age 18, with smears stained either by Romanowsky-Giemsa alone (Belarus, Tajikistan and Ukraine), or alternating with Papanicolaou (Kazakhstan and the Russian Federation). In parallel, screening programs using Papanicolaou or HPV test were introduced in seven countries and organized within primary care.</p></div><div><h3>Conclusion</h3><p>Our study documents that parallel screening systems for both breast and cervix cancers, as well as departures from evidence-based practices are widespread across the EECA. Within the framework of the WHO Initiatives, existing opportunistic screening should be replaced by population-based programs that include quality assurance and control.</p></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"38 ","pages":"Article 100436"},"PeriodicalIF":1.3,"publicationDate":"2023-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10072375","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-06-01DOI: 10.1016/j.jcpo.2023.100423
Timothée Olivier , Alyson Haslam , Vinay Prasad
Background
Financial difficulties in relation with diagnosis and treatment of patients with cancer affects their quality-of-life (QoL). We aim to characterize how financial toxicity was captured in oncology randomized clinical trials (RCTs), and to estimate how often the study-drug or other expenses were covered by sponsors.
Methods
This was a cross-sectional analysis of articles published in six high impact journals (The New England Journal of Medicine, The Lancet, JAMA, The Lancet Oncology, Journal of Clinical Oncology, and JAMA Oncology). Selected articles needed to report on a RCT published between January 2018 and December 2019, study an anti-cancer drug, and have reported QoL results. We abstracted the QoL questionnaires used; whether the survey was directly assessing financial difficulties; whether a difference in financial toxicity was reported between arms; and whether the sponsor supplied the study-drug or covered other expenses.
Results
For all 73 studies that met inclusion criteria, 34 studies (47%) utilized QoL questionnaires without direct assessment of financial difficulties. The study drug was provided by the sponsor in at least 51 trials (70%), provided according to local rules in 3 trials (4%), and undetermined in the remaining 19 trials (26%). We found 2 trials (3%) with payments or compensation to enrolled patients.
Conclusion
This cross-sectional study found 47% of articles reporting on QoL in oncology RCTs did not use QoL questionnaires directly assessing financial toxicity. Additionnaly, the study drug was supplied by the sponsor in most trials. Financial toxicity occurs in real-life settings when patients have to pay for the drugs and other medical expenses. QoL assessments from oncology RCTs lack generalizability to real-world settings, due to limited querying of financial toxicity.
Policy summary
Real-world evidence could be demanded by regulators as post-requirement studies to ensure QoL results observed in trials will replicate in patients treated outside investigational trials.
背景癌症患者在诊断和治疗方面的经济困难影响了他们的生活质量。我们的目的是描述肿瘤学随机临床试验(RCT)中财务毒性是如何被捕获的,并估计赞助商支付研究药物或其他费用的频率。方法这是对发表在六种高影响力期刊(《新英格兰医学杂志》、《柳叶刀》、《美国医学会杂志》、The Lancet Oncology、Journal of Clinical Oncology和JAMA Oncology)上的文章的横断面分析。所选文章需要报告2018年1月至2019年12月期间发表的RCT,研究抗癌药物,并报告QoL结果。我们提取了所使用的生活质量问卷;调查是否直接评估了财政困难;是否报告了武器之间在财务毒性方面的差异;以及申办方是否提供研究药物或承担其他费用。结果在所有73项符合纳入标准的研究中,34项研究(47%)使用了生活质量问卷,而没有直接评估经济困难。该研究药物由申办方在至少51项试验中提供(70%),在3项试验中根据当地规则提供(4%),在其余19项试验中未确定(26%)。我们发现有2项试验(3%)对入选患者进行了付款或补偿。结论这项横断面研究发现,47%的肿瘤学随机对照试验中报告生活质量的文章没有使用生活质量问卷直接评估经济毒性。此外,在大多数试验中,研究药物由赞助商提供。在现实生活中,当患者必须支付药物和其他医疗费用时,就会产生经济毒性。由于对财务毒性的查询有限,肿瘤学随机对照试验的生活质量评估缺乏对现实世界环境的可推广性。政策摘要监管机构可能会要求提供真实世界的证据作为需求后研究,以确保试验中观察到的生活质量结果将在试验外接受治疗的患者中复制。
{"title":"Is financial toxicity captured in quality of life assessments in oncology randomized clinical trials?","authors":"Timothée Olivier , Alyson Haslam , Vinay Prasad","doi":"10.1016/j.jcpo.2023.100423","DOIUrl":"10.1016/j.jcpo.2023.100423","url":null,"abstract":"<div><h3>Background</h3><p>Financial difficulties in relation with diagnosis and treatment of patients with cancer affects their quality-of-life (QoL). We aim to characterize how financial toxicity was captured in oncology randomized clinical trials (RCTs), and to estimate how often the study-drug or other expenses were covered by sponsors.</p></div><div><h3>Methods</h3><p>This was a cross-sectional analysis of articles published in six high impact journals (The New England Journal of Medicine, The Lancet, JAMA, The Lancet Oncology, Journal of Clinical Oncology, and JAMA Oncology). Selected articles needed to report on a RCT published between January 2018 and December 2019, study an anti-cancer drug, and have reported QoL results. We abstracted the QoL questionnaires used; whether the survey was directly assessing financial difficulties; whether a difference in financial toxicity was reported between arms; and whether the sponsor supplied the study-drug or covered other expenses.</p></div><div><h3>Results</h3><p>For all 73 studies that met inclusion criteria, 34 studies (47%) utilized QoL questionnaires without direct assessment of financial difficulties. The study drug was provided by the sponsor in at least 51 trials (70%), provided according to local rules in 3 trials (4%), and undetermined in the remaining 19 trials (26%). We found 2 trials (3%) with payments or compensation to enrolled patients.</p></div><div><h3>Conclusion</h3><p>This cross-sectional study found 47% of articles reporting on QoL in oncology RCTs did not use QoL questionnaires directly assessing financial toxicity. Additionnaly, the study drug was supplied by the sponsor in most trials. Financial toxicity occurs in real-life settings when patients have to pay for the drugs and other medical expenses. QoL assessments from oncology RCTs lack generalizability to real-world settings, due to limited querying of financial toxicity.</p></div><div><h3>Policy summary</h3><p>Real-world evidence could be demanded by regulators as post-requirement studies to ensure QoL results observed in trials will replicate in patients treated outside investigational trials.</p></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"36 ","pages":"Article 100423"},"PeriodicalIF":1.3,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9608676","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-06-01DOI: 10.1016/j.jcpo.2023.100418
Fidel Rubagumya , Jacqueline Galica , Eulade Rugengamanzi , Brandon A. Niyibizi , Ajay Aggarwal , Richard Sullivan , Christopher M. Booth
Background
Information and stories about cancer treatment are increasingly available to patients and the general public through lay media, websites, blogs and social media. While these resources may be helpful to supplement information provided during physician-patient discussions, there is growing concern about the extent to which media reports accurately reflect advances in cancer care. This review aimed to understand the landscape of published research which has described media coverage of cancer treatments.
Methods
This literature review included peer-reviewed primary research articles that reported how cancer treatments are portrayed in the lay media. A structured literature search of Medline, EMBASE and Google Scholar was performed. Potentially eligible articles were reviewed by three authors for inclusion. Three reviewers, each independently reviewed eligible studies; discrepancies were resolved by consensus.
Results
Fourteen studies were included. The content of the eligible studies reflected two thematic categories: articles that reviewed specific drugs/cancer treatment (n = 7) and articles that described media coverage of cancer treatment in general terms (n = 7). Key findings include the media’s frequent and unfounded use of superlatives and hype for new cancer treatments. Parallel to this, media reports over-emphasize potential treatment benefits and do not present a balanced view of risks of side effects, cost, and death. At a broad level, there is emerging evidence that media reporting of cancer treatments may directly impact patient care and policy-making.
Conclusions
This review identifies problems in current media reports of new cancer advances – especially with undue use of superlatives and hype. Given the frequency with which patients access this information and the potential for it to influence policy, there is a need for additional research in this space in addition to educational interventions with health journalists. The oncology community – scientists and clinicians – must ensure that we are not contributing to these problems.
{"title":"Media coverage of cancer therapeutics: A review of literature","authors":"Fidel Rubagumya , Jacqueline Galica , Eulade Rugengamanzi , Brandon A. Niyibizi , Ajay Aggarwal , Richard Sullivan , Christopher M. Booth","doi":"10.1016/j.jcpo.2023.100418","DOIUrl":"10.1016/j.jcpo.2023.100418","url":null,"abstract":"<div><h3>Background</h3><p>Information and stories about cancer treatment are increasingly available to patients and the general public through lay media, websites, blogs and social media. While these resources may be helpful to supplement information provided during physician-patient discussions, there is growing concern about the extent to which media reports accurately reflect advances in cancer care. This review aimed to understand the landscape of published research which has described media coverage of cancer treatments.</p></div><div><h3>Methods</h3><p>This literature review included peer-reviewed primary research articles that reported how cancer treatments are portrayed in the lay media. A structured literature search of Medline, EMBASE and Google Scholar was performed. Potentially eligible articles were reviewed by three authors for inclusion. Three reviewers, each independently reviewed eligible studies; discrepancies were resolved by consensus.</p></div><div><h3>Results</h3><p>Fourteen studies were included. The content of the eligible studies reflected two thematic categories: articles that reviewed specific drugs/cancer treatment (n = 7) and articles that described media coverage of cancer treatment in general terms (n = 7). Key findings include the media’s frequent and unfounded use of superlatives and hype for new cancer treatments. Parallel to this, media reports over-emphasize potential treatment benefits and do not present a balanced view of risks of side effects, cost, and death. At a broad level, there is emerging evidence that media reporting of cancer treatments may directly impact patient care and policy-making.</p></div><div><h3>Conclusions</h3><p>This review identifies problems in current media reports of new cancer advances – especially with undue use of superlatives and hype. Given the frequency with which patients access this information and the potential for it to influence policy, there is a need for additional research in this space in addition to educational interventions with health journalists. The oncology community – scientists and clinicians – must ensure that we are not contributing to these problems.</p></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"36 ","pages":"Article 100418"},"PeriodicalIF":1.3,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9617162","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-06-01DOI: 10.1016/j.jcpo.2023.100424
Sini M. Eskola , Hubertus G.M. Leufkens , Andrew Bate , Marie Louise De Bruin , Helga Gardarsdottir
Use of Real-World Data (RWD) has gained the interest of different stakeholders in cancer care. The aim of this study was to identify and describe the use of RWD/RWE during the pre-authorization phase of products authorized by the EMA in 2018 and 2019 (n = 111), with the focus on oncology medicines (n = 24). Information was extracted from the European Public Assessment Report (EPAR) summaries and recorded for 5 stages (11 categories) of the drug development lifecycle (discovery, early development, clinical development, registration/market launch, lifecycle management). Specific chapters of full EPAR were reviewed to substantiate the findings on RWD/RWE use in clinical trial design, efficacy, safety, and effectiveness evaluation. RWD/RWE is present in all stages of the oncology drug development; 100.0 % in discovery, 37.5 % early development, 58.3 % in clinical development, 62.5 % in registration decision and 100.0 % in post-authorization lifecycle management. Examples showed that trial design supported by RWD/RWE included use of open label/single arm studies; efficacy was about using either comparison of results to historical controls, supplying survey data obtained outside the clinical trial or utilizing expert panel advice; safety about including literature findings in evidence; and effectiveness on comparison of trial results of the given product to historical data or existing standard of care. The findings of this study provide specific insights into how RWD/RWE is used in development of cancer therapeutics, how it contributes to regulatory decision making and can guide further policy developments in this field.
{"title":"The role of Real-World Data and evidence in oncology medicines approved in EU in 2018–2019","authors":"Sini M. Eskola , Hubertus G.M. Leufkens , Andrew Bate , Marie Louise De Bruin , Helga Gardarsdottir","doi":"10.1016/j.jcpo.2023.100424","DOIUrl":"10.1016/j.jcpo.2023.100424","url":null,"abstract":"<div><p>Use of Real-World Data (RWD) has gained the interest of different stakeholders in cancer care. The aim of this study was to identify and describe the use of RWD/RWE during the pre-authorization phase of products authorized by the EMA in 2018 and 2019 (n = 111), with the focus on oncology medicines (n = 24). Information was extracted from the European Public Assessment Report (EPAR) summaries and recorded for 5 stages (11 categories) of the drug development lifecycle (discovery, early development, clinical development, registration/market launch, lifecycle management). Specific chapters of full EPAR were reviewed to substantiate the findings on RWD/RWE use in clinical trial design, efficacy, safety, and effectiveness evaluation. RWD/RWE is present in all stages of the oncology drug development; 100.0 % in discovery, 37.5 % early development, 58.3 % in clinical development, 62.5 % in registration decision and 100.0 % in post-authorization lifecycle management. Examples showed that trial design supported by RWD/RWE included use of open label/single arm studies; efficacy was about using either comparison of results to historical controls, supplying survey data obtained outside the clinical trial or utilizing expert panel advice; safety about including literature findings in evidence; and effectiveness on comparison of trial results of the given product to historical data or existing standard of care. The findings of this study provide specific insights into how RWD/RWE is used in development of cancer therapeutics, how it contributes to regulatory decision making and can guide further policy developments in this field.</p></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"36 ","pages":"Article 100424"},"PeriodicalIF":1.3,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9671048","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-06-01DOI: 10.1016/j.jcpo.2023.100414
Seamus O'Reilly , Hailey Kathryn Carroll , Deirdre Murray , Louise Burke , Triona McCarthy , Robert O’Connor , Claire Kilty , Sonya Lynch , Jennifer Feighan , Maeve Cloherty , Patricia Fitzpatrick , Katrina Falvey , Verena Murphy , Mary Jane O'Leary , Sophie Gregg , Leonie Young , Eilish McAuliffe , Josephine Hegarty , Anna Gavin , Mark Lawler , Maeve Mullooly
Upon the COVID-19 pandemic onset in Ireland, cancer service disruptions occurred due to prioritisation of COVID-19 related care, redeployment of staff, initial pausing of screening, diagnostic, medical and surgical oncology procedures, staff shortages due to COVID-19 infection and impacts on the physical and mental health of cancer healthcare workers. This was coupled with reluctance among people with symptoms suspicious for cancer to attend for clinical evaluation, due to concerns of contracting the virus. This was further compounded by a cyber-attack on national health service IT systems on May 14th 2021. The Irish Cancer Society, a national cancer charity with a role in advocacy, research and patient supports, convened a multi-disciplinary stakeholder group (COVID-19 and Cancer Working Group) to reflect on and understand the impact of the pandemic on cancer patients and services in Ireland, and discuss potential mitigation strategies. Perspectives on experiences were gathered across domains including timeliness of data acquisition and its conversion into intelligence, and the resourcing of cancer care to address cancer service impacts. The group highlighted aspects for future research to understand the long-term pandemic impact on cancer outcomes, while also highlighting potential strategies to support cancer services, build resilience and address delayed diagnosis. Additional measures include the need for cancer workforce recruitment and retention, increased mental health supports for both patients and oncology professionals, improvements to public health messaging, a near real-time multimodal national cancer database, and robust digital and physical infrastructure to mitigate impacts of the current pandemic and future challenges to cancer care systems.
{"title":"Impact of the COVID-19 pandemic on cancer care in Ireland – Perspectives from a COVID-19 and Cancer Working Group","authors":"Seamus O'Reilly , Hailey Kathryn Carroll , Deirdre Murray , Louise Burke , Triona McCarthy , Robert O’Connor , Claire Kilty , Sonya Lynch , Jennifer Feighan , Maeve Cloherty , Patricia Fitzpatrick , Katrina Falvey , Verena Murphy , Mary Jane O'Leary , Sophie Gregg , Leonie Young , Eilish McAuliffe , Josephine Hegarty , Anna Gavin , Mark Lawler , Maeve Mullooly","doi":"10.1016/j.jcpo.2023.100414","DOIUrl":"10.1016/j.jcpo.2023.100414","url":null,"abstract":"<div><p>Upon the COVID-19 pandemic onset in Ireland, cancer service disruptions occurred due to prioritisation of COVID-19 related care, redeployment of staff, initial pausing of screening, diagnostic, medical and surgical oncology procedures, staff shortages due to COVID-19 infection and impacts on the physical and mental health of cancer healthcare workers. This was coupled with reluctance among people with symptoms suspicious for cancer to attend for clinical evaluation, due to concerns of contracting the virus. This was further compounded by a cyber-attack on national health service IT systems on May 14th 2021. The Irish Cancer Society, a national cancer charity with a role in advocacy, research and patient supports, convened a multi-disciplinary stakeholder group (COVID-19 and Cancer Working Group) to reflect on and understand the impact of the pandemic on cancer patients and services in Ireland, and discuss potential mitigation strategies. Perspectives on experiences were gathered across domains including timeliness of data acquisition and its conversion into intelligence, and the resourcing of cancer care to address cancer service impacts. The group highlighted aspects for future research to understand the long-term pandemic impact on cancer outcomes, while also highlighting potential strategies to support cancer services, build resilience and address delayed diagnosis. Additional measures include the need for cancer workforce recruitment and retention, increased mental health supports for both patients and oncology professionals, improvements to public health messaging, a near real-time multimodal national cancer database, and robust digital and physical infrastructure to mitigate impacts of the current pandemic and future challenges to cancer care systems.</p></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":"36 ","pages":"Article 100414"},"PeriodicalIF":1.3,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9951610/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9615444","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}