International Standard Setting Research Articles

The International Standard Set of Outcome Measures for the Assessment of Hearing in People with Osteogenesis Imperfecta.

The aim is to recommend a minimum standard set of clinician-reported outcome measures (CROMs) and patient-reported outcome measures (PROMs) on hearing for people with osteogenesis imperfecta (OI). This project is part of the larger "Key4OI" project initiated by the "Care4BrittleBones foundation" of which the goal is to improve quality of life of people with OI. Key4OI provides a standard set of outcome measures and covers a large set of domains affecting the well-being of people with OI. An international team of experts in OI, comprising specialists in audiological science, medical specialists, and an expert patient representative, used a modified Delphi consensus process to select CROMs and PROMs to evaluate hearing problems in people with OI. In addition, focus groups of people with OI identified key consequences of their hearing loss. These criteria were matched to categories of preselected questionnaires to select a PROM that matched their specific hearing-related concerns best. Consensus on PROMs for adults and CROMs for adults and children was reached. The focus of the CROMs was on specific audiological outcome measures and standardized follow-up. This project resulted in a clear consensus statement for standardization of hearing-related PROMs and CROMs and follow-up management of patients with OI. This standardization of outcome measurements will facilitate comparability of research and easier international cooperation in OI and hearing loss. Furthermore, it can improve standard of care in people with OI and hearing loss by incorporating the recommendations into care pathways.

Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures.

Patient-reported outcomes (PROs), such as symptoms, functioning, and other health-related quality-of-life concepts are gaining a more prominent role in the benefit-risk assessment of cancer therapies. However, varying ways of analysing, presenting, and interpreting PRO data could lead to erroneous and inconsistent decisions on the part of stakeholders, adversely affecting patient care and outcomes. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI) Consortium builds on the existing SISAQOL work to establish recommendations on design, analysis, presentation, and interpretation for PRO data in cancer clinical trials, with an expanded set of topics, including more in-depth recommendations for randomised controlled trials and single-arm studies, and for defining clinically meaningful change. This Policy Review presents international stakeholder views on the need for SISAQOL-IMI, the agreed on and prioritised set of PRO objectives, and a roadmap to ensure that international consensus recommendations are achieved.

A core syllabus for histology within the medical curriculum - The cardiovascular and lymphoid systems, the respiratory and digestive systems, and the integument.

Medical courses worldwide are undergoing significant curricular changes, including the teaching and learning of histology. In order to set international standards for the anatomical sciences, the International Federation of Associations of Anatomists (IFAA) is developing core anatomical syllabuses by means of Delphi panels. Already published is a core syllabus for the teaching of the cell and the basic tissues within medicine. Here, we record the deliberations of an IFAA Delphi panel commissioned to develop core subject matter for the teaching within a medical histology course of the cardiovascular and lymphatic circulatory system, the lymphoid, respiratory, and digestive systems, and the integument. The Delphi panel was comprised of academics from multiple countries who were required to review relevant histological topics/items by evaluating each topic as being either "Essential," "Important," "Acceptable," or "Not required." Topics that were rated by over 60% of the panelists as being "Essential" are reported in this paper as being core topics for the teaching of medical histology. Also reported are topics that, while not reaching the threshold for being designated as core material, may be recommended or not required within the curriculum.

SME owners and accountants' perceptions of financial information in small- and medium-sized entities: a Sri Lanka case study

PurposeThis paper aims to examine the perceptions of owners and accountants of small- and medium-sized entities (SMEs) on the users and their financial information needs of SME financial reporting.Design/methodology/approachPostal questionnaire surveys with owners and accountants of SMEs were used to identify users and their financial information needs. In total, 1,498 questionnaires were sent to SME owners and accountants. A total of 358 questionnaires were returned, generating 323 useable questionnaires. The management branch of stakeholder theory is used for the study which asserts that company management is expected to meet the expectations of those stakeholders who are more powerful than others.FindingsThe users of Sri Lanka SME financial information were limited to owners, banks and Department of Inland Revenue. Users and financial information needs of owners varied in relation to the size of the SME. Financial information are useful for making capital investment and planning decisions for owners regardless of the size of the SME. By sharing information with outside parties, disclosures can diminish information asymmetries between the firms and its stakeholders. The top three reasons for which owners use SME financial information are for planning purposes, estimating income tax liabilities, and taking marketing and pricing decisions.Research limitations/implicationsSince the study focuses only on the views of owner-managers and accountants of SMEs, the holistic understanding of uses of SME financial information by other user groups cannot be achieved.Practical implicationsThe results of this study provide international and local standard setters with an indication of future direction for SME financial reporting.Social implicationsThis paper extends existing knowledge on users and their financial information needs of SMEs in developing countries. Consequently, the findings of this paper make a valuable contribution to the work of practitioners such as local and international standards-setters and regulators who may be considering developing/revising financial reporting framework for SMEs either worldwide or in developing countries.Originality/valueAlthough SME financial reporting has attracted enormous attention in the recent accounting literature, academic research into SME financial reporting is scant. This paper extends existing knowledge on users and their financial information needs of SMEs in developing countries. The general purpose financial reporting model and the accounting standard IFRS for SMEs in particular would not be applicable to Sri Lankan SMEs unless it modifies to reflect the financial information needs of users of Sri Lankan SME financial information.

Single-arm studies involving patient-reported outcome data in oncology: a literature review on current practice.

Patient-reported outcomes (PROs) are increasingly used in single-arm cancer studies. We reviewed 60 papers published between 2018 and 2021 of single-arm studies of cancer treatment with PRO data for current practice on design, analysis, reporting, and interpretation. We further examined the studies' handling of potential bias and how they informed decision making. Most studies (58; 97%) analysed PROs without stating a predefined research hypothesis. 13 (22%) of the 60 studies used a PRO as a primary or co-primary endpoint. Definitions of PRO objectives, study population, endpoints, and missing data strategies varied widely. 23 studies (38%) compared the PRO data with external information, most often by using a clinically important difference value; one study used a historical control group. Appropriateness of methods to handle missing data and intercurrent events (including death) were seldom discussed. Most studies (51; 85%) concluded that PRO results supported treatment. Conducting and reporting of PROs in cancer single-arm studies need standards and a critical discussion of statistical methods and possible biases. These findings will guide the Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Data in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI) in developing recommendations for the use of PRO-measures in single-arm studies.

Corporate governance and risk management in Islamic and convectional financial institutions: explaining the role of institutional quality

PurposeThis study aimed at exploring the differential effects of different corporate governance (CG) indicators on risk management practices in Islamic financial institutions (IFIs) and conventional financial institutions (CFIs) of Pakistan. It also investigated the moderating role of institutional quality (IQ) in shaping the effects of CG practices on financial institutions of Pakistan.Design/methodology/approachA sample of 57 financial institutions including commercial banks, insurance companies and Modarba companies over the period 2006–2017 is used to carry out the empirical analysis. The authors applied the robust two-step system-generalized method of moments estimator, which is also called the dynamic panel data estimator. They also built the PCA-based composite index of CG and IQ by using different indicators to investigate the moderating role of IQ. They used three proxies for risk taking, five for CG and one for Shari’ah governance. To test the validity of the instruments, they applied the Arellano and Bond’s (1991) AR (1) and AR (2) tests and the J-statistic of Hansen (1982).FindingsThe results provided strong evidence that several individual characteristics of CG and the composite index are significantly related to the operational risk, the liquidity risk and the Z-score (a proxy for solvency risk). The results also revealed that IQ significantly and substantially contributes in reducing the level of risks. Finally, the estimation results indicated that the effects of CG on risk management are significantly different at IFIs and CFIs. This differential impact is mainly attributed to the fundamental differences in business models, operational strategies and contractual obligations of both types of institutions.Practical implicationsThe findings of this study are important for enhancing our understanding of how CG relates to risk taking in Islamic and conventional financial services industries and how good quality institutions are important for formulating the governance effects on the risk-taking behavior of financial institutions. The findings suggest that a suitable size of board should be chosen to manage the risk effectively. As the findings show that the risk-taking behavior of IFIs differs from that of CFIs, the regulators and international standard setting bodies should tailor the regulatory frameworks accordingly.Originality/valueThis paper is different from the existing studies in four aspects. First, to the best of the authors’ knowledge, this is the first empirical investigation in Pakistan, which does the comparison of IFIs and CFIs while examining the impacts of CG on risk management. Second, the paper constructs the composite index of CG by considering several different indicators of governance and examines the combined effect of governance indicators on risk management process. Third, this paper adds to the growing literature on the role of IQ by investigating whether it acts as a moderator between CG structures and risk management and if yes, then whether this moderating role is different for IFIs and CFIs. Finally, the paper builds upon the existing research work on the CG effects for different types of financial institutions by proposing a single regression based analytical framework for comparing the effects across two different types of institutions, harvesting the benefits of higher degrees of freedom and avoiding/minimizing the measurement error.

Advancement and benefits associated with ISO 9000 series

ISO 9000 is a set of internationally recognized standards for quality assurance and management. Published by the International Organization for Standardization, it aims to encourage the production of goods and services that meet a globally-acceptable level of quality. ISO 9000 is a quality management standard that presents guidelines intended to increase business efficiency and customer satisfaction. The goal of ISO 9000 is to embed a quality management system within an organization, increasing productivity, reducing unnecessary costs, and ensuring quality of processes and products.ISO 9000 was first published in 1987 by the International Organization for Standardization (ISO). It was based on the BS 5750 series of standards from BSI that were proposed to ISO in 1979.. ISO 9000 is defined as a set of international standards on quality management and quality assurance developed to help companies effectively document the quality system elements needed to maintain an efficient quality system. They are not specific to any one industry and can be applied to organizations of any size. They are issued by certification/registration bodies (also called Registrars or CB's), which are independent of ISO. CB's need to be accredited by an IAF member to be internationally recognized. ISO 9001 supports you to increase the control of your business processes. The more you control your business, the more your consistency rises. Increased consistency means your customers are getting the same good service or same good products every time they are making business with you. ISO 9000 aims to improve quality and facilitate business objectives.

Sustainability Reporting: Is Convergence Possible?

In this essay, we discuss the factors influencing the likelihood of convergence in corporate sustainability reporting. We identify several factors that negatively influence the probability of convergence in the short term. The first factor is the heterogeneity of concepts and definitions surrounding sustainability (e.g. ESG, CSR). This heterogeneity of definitions is pervasive at three levels: (1) across organizations claiming legitimacy in sustainability reporting standard-setting, (2) within standard-setting organizations over time, and (3) across firms reporting about their activities. A second factor is the large number of organizations claiming legitimacy in sustainability reporting. A third factor is related to a diversity of reporting requirements among three influential international standard setters (i.e. EFRAG, ISSB, SEC), leading to various corporate reporting choices. A fourth factor is the diversity in the objectives of standard-setting organizations. Overall, we believe that due to these sources of diversity, the probability of convergence in sustainability reporting appears limited, at least in the short term, although we identify progress in carbon emissions reporting.

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Past, present, and future of carbon accounting: Insights from scholarly research

Although accounting functions have been expanded from traditional practices to recent practices, focusing on environmental, social, and governance issues, there is still a shortcoming in conceiving different approaches to creating organizational and human interaction with the environment. In this study, we review the existing research on carbon accounting from 1994 to July 2022 in order to examine its intellectual development and make recommendations for future studies. This study also discusses the scales, methodological choices, and major themes of carbon accounting research, including the most influential articles and top contributing countries, journals, theories, and institutions. The literature was retrieved from the Web of Science (WoS) and Scopus databases, in which 137 articles were obtained from 62 high-quality journals in accounting, environment, and economics. There has been a significant increase in recent years in the number of studies, with the majority taking place in the United Kingdom, Australia, and China, as compared to the United States. On the other hand, the results show that traditional theories, such as the theory of legitimacy, the theory of organization, and the theory of stakeholders, have been evaluated previously. Although a firm’s characteristics and consumer behavior play an important role in improving carbon efficiency, economic and behavioral theories have been underrepresented in the existing literature. Furthermore, it is found that carbon accounting research provides a mechanism through which carbon emissions can be measured and quantified and helps in knowing the emissions status of companies and making the necessary strategic decisions to achieve mitigation. Therefore, policymakers have to foster setting international standards that would compile firms to report their carbon strategies similar to the international financial reporting standards, allowing investors to verify and compare firms that perform well in terms of carbon reduction.

In Search of Double Materiality in Non-Financial Reports: First Empirical Evidence

Materiality is the key principle that drives the selection of issues that companies must report on. The European Union regulation on companies’ non-financial disclosure coined a special meaning of materiality that holistically combines the two perspectives of financial and impact materiality into an overall “double materiality” (DM). The contrast detected between the early debate and the low level of empirical knowledge on DM provided by the literature on materiality disclosure gave rise to our research aim, which was to map the pioneering experiences of DM. In order to achieve this aim, we carried out an exploratory analysis on the non-financial reports of 58 companies, both European and non-European, operating in various industries (period 2019–2021). The results reveal “traces” of DM in the reports of few companies, mainly European ones. The aspects we examined, both with atomistic and summative perspectives of inquiry, highlight variety in both double materiality assessments and adoption disclosures, as well as related criticalities. This foreshadows a fragmented landscape of materiality analysis disclosure over the next few years that presently requires great attention and increased operational guidance by the international standard setters involved. The article closes by proposing implications, limitations and research perspectives.

ДЕЯКІ АСПЕКТИ МІЖНАРОДНО-ПРАВОВОЇ РЕГЛАМЕНТАЦІЇ БЕЗПЕКИ СУДНОПЛАВСТВА

The problem of ensuring the safety of navigation remains acute in maritime transport, which is one of the key issues in international trade. To implement the safety of navigation, the world community is taking steps to unify international standards, enshrine international law in national legislation, as well as strengthen the requirements for technical means of navigation. Despite the constant development of methods, techniques and technical means of safety, several thousand ships crash at sea every year, so this article is intended to highlight some aspects of international legal regulation of shipping safety. This problem has long crossed the boundaries of national and international. The main object of maritime safety, of course, is the ship as the main participant in maritime transport. The factors that pose a threat to a ship are different. This includes both weather conditions and the human factor, and the technical characteristics of the vessel. The issue of maritime safety is of a fundamental nature, and the key difficulty for its optimal solution is to distinguish between the very concept of "maritime safety" and ensuring shipping as such, ie its functional efficiency. Shipping, in the modern world, has occupied a huge niche in trade, economy, and in the transportation and service of passengers. That is, this process serves to meet the cultural, economic, scientific, recreational and other needs of mankind. Therefore, maritime safety must be ensured by both economic and legal aspects. And also for this it is necessary to create appropriate conditions for the transportation of various cargoes, for the comfort of passengers, to ensure the deployment and the necessary functioning of the navigation system, which will allow ships to follow the most profitable route with maximum safety. Given the above, this article analyzes a set of international legal standards, maritime customs and maritime practices designed to ensure the safety of navigation.

Critical Analysis of Patent Laws in Pakistan Since Independence

Intellectual property is the creative expression based on which there is the public willingness to bestow the status of the property and a patent is a recognition of an invention, which satisfies the criteria of novelty, non-obviousness, and industrial application. This paper aims to discuss the evolution of Patent laws in Pakistan. It primarily looks into the transitional phases of the patent to remain in line with the international agreement i.e. Trade-Related Aspects of Intellectual Property laws. It then examines the extent to which safeguards have historically been used in patent laws for public interest and also to meet policy objectives. This research further aimed to trace out the discrepancies in the patent law, if any, to bring those issues into the limelight and thereafter to suggest recommendations to upgrade the law accordingly. For this purpose, the available literature was reviewed through a hand search method i.e.research articles, books and websites were explored and after in-depth analytical reading, the main themes were extracted for this study. The findings indicated that the Patent Law of Pakistan is at par with the set international norms, however, there is always space for improvement to keep at par with the set international standards.

Value relevance of general government national accounts with ESA2010 accrual accounting framework. Association of ESA2010 reporting quality with decision making and accounting standardisation

Purpose: The necessity for a reliable set of international standards for the compilation of national accounts introduced the accrual accounting framework of the European System of Accounts (ESA 2010). Extensive efforts are made for convergence between Government Accounts (GA) and National Accounts (NA) under accounting standards. Design/methodology/approach: This study investigated the quality of governmental NA, in the context of ESA 2010, from 1999 through 2019, using relative value relevance models of long-term government bond yields. Findings: i) The accrual accounting framework ESA2010 generates value relevant (thus qualitative) NA financial reporting in EU member states and the United Kingdom (UK); ii) The financial variables that better interpret bonds’ return, thus governments’ necessity to borrow money, are showcased; iii) The usefulness of the ESA2010 conceptual framework for decision and policy making process considering that the accrual accounting basis fosters the financial reporting quality, is demonstrated; iv) The quality results set the premise for further discussion for the harmonization and alignment process of accounting standardisation with the ESA2010 accrual accounting framework as a resource for policy and decision making. Limitations: The methodology of value relevance models that is employed to assess the governmental statistical reporting quality with the ESA2010 accrual accounting framework is a private sector technique. Originality: This study contributes theoretically as it fosters the quality of accrual accounting basis. It moreover provides an empirical and practical contribution by introducing relative value relevance econometric models that provide stakeholders with reliable information on the financial position and performance of the government. It showcases significant financial variables and coefficients of statistical reporting for each government. With its value relevant results, it supports evidence-based decision making, allows comparisons between EU governments and the UK, and contributes to increased transparency and accountability.

Measurement of Spectral Match and Spatial Non-uniformity for Indoor Solar Simulator

This paper presents a study on the measurement of spectral match and spatial non-uniformity of the indoor solar simulator available in Universiti Teknikal Malaysia Melaka (UTeM). This indoor solar simulator which was successfully fabricated at the Applied Solar Energy Laboratory (ASEL) had used the quartz tungsten halogen lamp as its only light source. Upon its fabrication, the reliability of ASEL’s solar simulator has not been proved yet as there is no concrete evidence that it had followed the international standard set for solar simulator. Therefore, the motivation of this study had been set to determine the characteristics of the indoor solar simulator in term of its spectral match and spatial non-uniformity. The literature review conducted has revealed that there are few methods that been practiced to determine both cases. For the spectral match test, the experimental works chosen for this research was the mathematical modelling method. Meanwhile, for the spatial non-uniformity test, irradiance mapping method was used where the reading of irradiance intensity at each coordinate across the map was measured. At the end of this study, it shows that at 400-500nm and 500-600 wavelength range, the value of spectral match value obtained was 0.40 and 1.46 respectively; whereas for 600-700nm range, the spectral match measured was beyond the standard range set. On the other hand, this study also reveals that the solar simulator was capable to produce 8.42% of spatial non-uniformity across the tested area of 104cm x 80cm. The average irradiance intensity recorded for this test was 981.98 W/m2.

ROLE OF PARTICIPATORY GOVERNANCE IN SAFEGUARDING THE TRADITION OF THE SONG AND DANCE CELEBRATION

The authors discuss the role of participatory governance in safeguarding and developing intangible cultural heritage using the Nationwide Song and Dance Celebration (SDC) tradition as an example for an analysis. Although the surveys of the community show that the SDC tradition maintenance is considered to be satisfactory and the organisational system at the moment is working fine, for fostering the tradition and increasing the role of the tradition bearers’ stronger involvement and support for the bottom-up activities of the community would be recommended. This is also needed to develop a more democratic and sustainable approach to safeguarding intangible cultural heritage, as recommended by the international standard setting instruments that introduce the concept of participatory governance. Moreover, occasional dissatisfaction with authoritarian and top-down governance of the SDC emerges in public and social media, implicitly indicating the need for a more bottom-up approach and greater involvement of community members in the decision making. In addition, the principles of participatory governance should be incorporated in the Song and Dance Celebration Law to be in line with the more recent Law on Intangible Cultural Heritage. Taking into account the activities of the most powerful NGO Latvian Song Celebrations Society, the overall direction can be considered as positive, although there is still a need for improvements.

The status and development proposal of carbon sources and sinks monitoring satellite system

In order to mitigate global warming, the international communities actively explore low-carbon and green development methods. According to the Paris Agreement that came into effect in 2016, there will be a global stocktaking plan to carry out every 5 years from 2023 onwards. In September 2020, China proposed a "double carbon" target of carbon peaking before 2030 and carbon neutrality before 2060. Achieving carbon peaking and carbon neutrality goals requires accurate carbon emissions and carbon absorptions. China's existing carbon monitoring methods have insufficient detection accuracy, low spatial resolution, and narrow swath, which are difficult to meet the monitoring requirement of carbon sources and sinks monitoring. In order to meet the needs of carbon stocktaking and support the monitoring and supervision of carbon sources and sinks, it is recommended to make full use of the foundation of the existing satellites, improve the detection technical specifications of carbon sources and sinks monitoring measures, and build a multi-means and comprehensive, LEO-GEO orbit carbon monitoring satellite system to achieve higher precision, higher resolution and multi-dimensional carbon monitoring. On this basis, it is recommended to strengthen international cooperation, improve data sharing policy, actively participate in the development of carbon retrieval algorithm and the setting of international carbon monitoring standards, establish an independent and controllable global carbon monitoring and evaluation system, and contribute China's strength to the global realization of carbon peaking and carbon neutrality.

CBDCs and the More Proactive Roles of International Organizations

With the rise of cryptocurrency, along with the downward trend of physical currency usage, which was especiallyaccelerated during the COVID-19 pandemic, many national governments are exploring the idea of implementingcentral bank digital currencies (CBDCs). While CBDCs are like cryptocurrencies in that they are digital, theiroverarching concept is different. They are issued by a country’s central bank or monetary authority undergovernment control, so they are centralized and equal in value to the nation’s fiat currency. This article aims toprovide a succinct summary of what CBDC implementation could mean for nations and their citizens, with a focuson the possible routes in and impacts on developing countries in light of the potential that CBDCs could providethem. Section 1 explores the rise of CBDCs, namely, the recent surge in developing nations’ interest in themworldwide. Section 2 discusses the benefits of CBDCs, partitioning the potential upsides into four majorpoints—greater accessibility, easier domestic and cross-border transactions, cost-efficient management, and moretransparent foreign aid—with a focus on developing countries. Section 3 provides a list of the challengesaccompanying CBDC implementation, such as an exhaustive complex framework, questionable financial stability,and technological infrastructure. Section 4 presents the roles that international organizations, such as the IMF andthe BIS, could play in the entire process writ large, ranging from setting international standards, intervening duringfinancial crises, and providing infrastructural support to incentivizing CBDC adoption. Section 5 concludes thearticle.

Disclosure of key audit matters (KAMs) in financial reporting: evidence from an emerging economy

PurposeThe new audit regulation for disclosure of key audit matters (KAMs) in financial reporting has been introduced in both developed and developing countries. This study investigates the influence of three distinctive sets of variables, namely industry features, firm characteristics and auditor attributes, on the extent, pattern and level of disclosure of KAMs by companies listed in Bangladesh, an emerging economy.Design/methodology/approachThe study uses qualitative and quantitative research approaches to investigate the pattern of disclosure of KAMs and their determinants. With a sample of 447 firm-year observations from companies listed on the Dhaka Stock Exchange over 2018–2020, the study reveals industry-level, firm-level and auditor-specific characteristics that affect KAMs' communication in the new audit reporting model.FindingsThe findings suggest that significant differences exist between firms in the number and types of KAMs reported and the extent of their disclosure. The study findings also observed variations both within and across different industry sectors. Highly regulated firms disclose a greater number of KAMs, while environmentally sensitive firms are found to provide a greater detail of the issues presented as KAMs. Further, both firm size and age positively impact the number of KAMs disclosed and the extent of the disclosure provided. Big-4-affiliated auditors do not issue a significantly higher number of KAMs but deliver extensive details to their KAMs description, compared to non-Big-4 auditors. In addition, while auditors, in general, tend to issue boilerplate KAMs, Big-4 associates are found to disclose more new KAMs. However, audit fees and auditor rotation do not influence KAMs disclosure.Research limitations/implicationsThis study is based on two years of publicly available data. However, future studies could consider in-depth interviews to explore the motivation behind KAMs' disclosure in Bangladesh and other developing countries with similar cultural and contextual values.Practical implicationsThese findings have substantial policy considerations for improving firms' audit quality and, thus, their financial reporting quality, with implications for national and international standard-setters, regulators and other stakeholders.Originality/valueThis study is one of the earliest endeavours to investigate KAMs in a context of an emerging country, such as Bangladesh, which adopted KAMs' disclosure in 2018.

Association of Anticancer Immune Checkpoint Inhibitors With Patient-Reported Outcomes Assessed in Randomized Clinical Trials

The association of immune checkpoint inhibitors (ICIs) with patient quality of life has been poorly explored. To evaluate patient-reported outcomes (PROs) assessed in randomized clinical trials (RCTs) of immunotherapy-based treatments. This systematic review and random-effects meta-analysis used RCTs identified in PubMed, MEDLINE, Embase, and Scopus from database inception to June 1, 2021. A total of 2259 RCTs were identified that assessed ICIs as monotherapy or in combination with chemotherapy or combined with another ICI and/or targeted therapy vs control groups not containing immunotherapy in patients with advanced solid tumors. Studies were reviewed independently by 2 authors. This meta-analysis followed the PRISMA guidelines and recommendations of the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium. The coprimary aims of the meta-analysis were (1) pooled differences between treatment groups in the mean change of PRO score from baseline to 12 and 24 weeks of follow-up and (2) pooled differences between treatment groups in the time to deterioration of PRO score. For each end point, RCTs have been analyzed according to the type of treatment administered in the experimental group: ICIs given as monotherapy, ICIs combined with chemotherapy, or ICIs in association with another ICI and/or with targeted therapies. Of the 2259 identified RCTs, 34 (18 709 patients) met the selection criteria and were analyzed. In the group of 19 RCTs testing ICIs as monotherapy, the pooled between-groups difference of mean change from baseline to 12 weeks of follow-up was 4.6 (95% CI, 2.8-6.4), and the mean change from baseline to 24 weeks of follow-up was 6.1 (95% CI, 4.2-8.1), significantly favoring ICIs. The pooled difference was 1.4 (95% CI, -0.4 to 3.2) at week 12 and 2.5 (95% CI, -0.8 to 5.9) at week 24 in the group of 8 RCTs testing ICIs combined with chemotherapy and 2.1 (95% CI, -0.8 to 5.0) at week 12 and 2.1 (95% CI, -0.4 to 4.5) at week 24 in the group of 8 RCTs testing other ICI-containing combinations. The time to deterioration was significantly longer in the immunotherapy-containing groups compared with control groups in all 3 groups of RCTs evaluated (hazard ratios of 0.80 [95% CI, 0.70-0.91] for ICIs as monotherapy, 0.89 [95% CI, 0.78-1.00] for ICIs plus chemotherapy, and 0.78 [95% CI, 0.63-0.96] for other ICI-containing combinations). Immune checkpoint inhibitors as monotherapy appear to have a favorable association with patient-reported quality of life and can be combined with other classes of anticancer drugs without worsening this quality of life.