Final Amendments Research Articles

Preliminary test of Polish translation of the Rheumatoid and Arthritis Outcome Score - observational study.

Today, patients with inflammatory joint diseases participate in more physical activities, including sports and recreation. The tools currently used to assess quality of life and functioning in rheumatic diseases, available in Polish, do not address these problems. The Rheumatoid and Arthritis Outcome Score (RAOS) questionnaire was developed but is not available in the Polish language. This tool is used to evaluate the functional limitations of physically active people who suffer from arthritis and associated lower limb disorders. The objective of this study is the translation and cross-cultural adaptation of the RAOS into Polish. The process was carried out following the guidelines of the Evidence-Based Medicine Committee of the American Academy of Orthopaedic Surgeons (AAOS). The translation included forward and back translation, and synthesis of the transcripts. The RAOS was pre-tested in a target setting in 19 patients and final amendments were made to address concerns raised by the patients. The translation, adaptation, and pre-test of the Polish RAOS resulted in the final version of the scale, which can be found in Supplementary material 1. During pre-testing, the scale demonstrated ease of understanding, with patient feedback leading to minor corrections that were incorporated into the questionnaire structure. Before widespread implementation, a crucial step involves validating the scale through rigorous psychometric tests, including assessments of the reliability, validity and stability of the Polish RAOS. The lack of validation of the translated Polish version limits the use of the RAOS in the research environment. To solve this problem, the validation process is planned to be carried out in the next stage.

Evaluation of psychometric properties of the Persian version of the predicaments questionnaire, exploring social attitudes to suicide.

Due to the growing prevalence of suicide, assessing people's attitudes toward suicide is necessary. Therefore, this study aimed to examine the psychometric properties of the Persian version of the Predicaments Questionnaire (PQ), measuring social attitudes toward suicide. This psychometrics study evaluated face validity, content validity, temporal stability, internal consistency, and construct validity. First, the questionnaire was translated into Persian by the translate-back-translate method. The Persian version was provided to 10 experts in psychiatry for further revision. Two indicators, CVR and CVI, were calculated to evaluate the content validity. To check the face validity, we prepared a form and gave it to 10 people outside the campus to submit their opinions. Temporal stability was investigated by the test-retest method, reporting Intraclass correlation (ICC). Internal consistency was assessed by reporting Cronbach's alpha and McDonald's Omega coefficients. Construct validity was assessed using the confirmatory factor analysis to determine the number of dimensions of the questionnaire. A total of 151 students were enrolled with a mean age of 25 (SD = 0.32). The Persian PQ was valid in terms of content validity and face validity. Furthermore, it was reliable as Cronbach's alpha, McDonald's Omega, and the ICC were 0.94, 0.943, and 0.998, respectively. In addition, the confirmatory factor analysis yielded one dimension. Finally, after reviewing the experts' comments, the final amendments were made, and only question 29 was removed from the final version. Consequently, the Persian version of the PQ is acceptable in terms of content validity, face validity, temporal stability, and internal consistency.

Development of the Student Practice Evaluation Form - Revised (Second Edition) (SPEF-R2): The second action research cycle.

IntroductionThe Student Practice Evaluation Form – Revised Edition (SPEF‐R) was used across Australian universities from 2008 to 2020 to assess occupational therapy student performance on practice placement. Evolution of practice contexts, placement models and professional competency standards prompted updating of the tool. This paper describes the second and final action research cycle in the development of the SPEF‐R2.MethodsCycle 2 included three phases: (a) piloting of the SPEF‐R2 and post‐pilot survey to determine utility and applicability; (b) post‐pilot focus groups/interviews; and (c) final amendments for publication and launch. Quantitative data were summarised descriptively, and qualitative data were analysed using qualitative content analysis and reported using illustrative quotes.ResultsIn Phase 1, 23 participants piloted the SPEF‐R2 and completed a post‐pilot survey. Results indicated participants found the SPEF‐R2 relevant to a range of traditional and contemporary settings, easy to understand and an improvement over the previous version of the tool. Most participants found it more concise and less repetitive than the SPEF‐R. Participants particularly valued additions regarding culturally responsive practice, student health and well‐being and reflective practice. In Phase 2, five post‐pilot focus groups/interviews were held, gathering a deeper understanding of its utility. Discussion highlighted desire for an additional core item within the self‐management domain (Domain Two). Increased confidence in rating and provision of feedback on student performance were also evident. Reflection on findings led to final amendments and publication of the SPEF‐R2.ConclusionExtensive consultation with the occupational therapy community informed the development of the SPEF‐R2, reflecting contemporary practice and meeting the expectations of Australian occupational therapists. Action research was an effective approach to the development of the SPEF‐R2. Use of the manual and training website and support from universities are paramount if practice educators are to use the tool effectively.

Development of an individualised primary care program for acute low back pain using a hybrid co-design framework.

Low back pain is the leading worldwide cause of years lost to disability and the problem is worsening. This paper describes and demonstrates the scholarly development and contextual refinement of a primary care program for acute low back pain in Sydney, Australia. Hybrid theoretical frameworks were applied, and co-design was used to contextualise the program to the local healthcare setting. The program was developed in four stages. In stage 1, the scientific evidence about management of acute low back pain in primary care was examined. In stage 2, stakeholders (patients and clinicians) were consulted in nationwide surveys. Data from stages 1 and 2 were used to design an initial version of the program, called My Back My Plan. Stage 3 involved the contextual refinement of the program to the local setting, MQ Health Primary Care. This was achieved by co-design with primary care clinicians and patients who had sought care for low back pain at MQ Health Primary Care clinics. In stage 4, a panel of Australian experts on clinical care for low back pain reviewed the contextualised version of My Back My Plan and final amendments were made. My Back My Plan has been developed using an innovative scholarly approach to intervention development.

Thirty Years of Changes and the Current State of Swedish Animal Welfare Legislation.

Simple SummarySweden is often cited as a leading country in animal welfare and related legislation, but some recent changes in the national legislation are seen as lowering the animal welfare requirements in order to improve the competitiveness of Swedish farmers. In this study, we analysed suggested changes to the Swedish welfare legislation between 1988 and 2019 relating to horses, cattle and pigs, including the written motivations, the written stakeholder responses and the actual changes to the final regulations. We used a sample of 77 legal requirements to assess in depth whether the animal welfare level was affected by these changes in the legislation. The results showed that the animal welfare requirements in Sweden for cattle, pigs and horses increased overall during the 30-year study period, but that a number of specific requirements had been relaxed to satisfy interests other than animal welfare. Thus, the new requirements should be evaluated more fully in order to determine whether they serve their purpose in practice.Sweden is often seen as a leading country in animal welfare and legislation, but some recent amendments to the legislation are perceived as relaxing animal welfare requirements in order to improve the competitiveness of the relevant industry and of farmers. In this study, we analysed the suggested and actual changes in the Swedish national animal welfare regulations relating to horses, cattle and pigs between 1988 and 2019 and the consequences for the intended animal welfare level. The regulations and amendments, including the proposals, the written motivations, the stakeholders’ written responses to the proposed amendments and the final amendments, were scrutinised in detail. A sample of 77 requirements was then selected to assess whether and how the animal welfare level was affected by these legislative changes. The results indicated that the animal welfare protection level for cattle, pigs and horses increased overall during the 30-year period, but that a number of specific requirements had been relaxed to meet objectives other than animal welfare. It was more difficult to determine whether animal welfare improved in practice during the same period, due to the lack of systematic evaluations of the consequences of amending the regulations. Future evaluations are needed to evaluate the outcome of new legislative requirements and to monitor whether they serve their purpose in practice.

Going Dark

Going Dark

Українському народу – стабільний планомірностійкий людський розвиток (оцінка стану науково-адміністративного забезпечення). Частина І. Загальна ситуація зі стратегічним плануванням людського розвитку в Україні

The article reveals constructive ideas, recommendations and proposals for the establishment and development of scientific-methodological and methodological and administrative support of stable planned ustoichivogo regional human development in Ukraine. Carried out a detailed analysis of the publications of the Discussion club scientific journals of economic Sciences of and Economic Bulletin of Donbass during the 2014 - 2020рр., prepared by Professor V. F. Stolyarov and Ph. D. students O. V. Shinkaryuk. Details the article considers the conceptual provisions of the justification of the project of European integration on the principles chelovecheskogo approach under the slogan Ukrainian people – planned Recommendations and suggestions for the development of National and Regional programs of human development is presented as a fundamentally new direction of improvement of the existing in Ukraine the market economy on the basis of improving the social and state. The estimates of Index of regional human development in administrative areas using the methodology of its measurement 2012 institualization in coherence with the Millennium Development Goals for the period up to 2015 and Sustainable Development Goals for the period up to 2030. Formulation of problems of scientific and methodological support of stable planned ustoichivogo human development in the regions revealed in the theoretical, methodological and methodological and administrative aspects of the development of State and Regional development strategies for the period up to 2027. Systematic stages of formation of administration of the measurement and state regulation of regional human development. Recommendations and suggestions for shaping the final version or amendments of the State strategy of regional development of Ukraine in 2021-2027. Submitted 5 five discussion questions for evaluation of scientific and administrative support for the strategic planning and state regulation of regional human development in Ukraine. Proposed to develop a Planned code of Ukraine and introduce the harmonious proportions of the Golden section in the ratio of local budgets in the Consolidated state budget of Ukraine for the implementation of fiscal federalism with the aim of improving the financial autonomy of the administrative regions of a unitary state.

Broad Consent for Future Research: International Perspectives

AbstractIn the United States, final amendments to the Federal Policy for the Protection of Human Subjects (“the Common Rule”) were published on January 19, 2017, and they will take effect on January 21, 2019. One of the most widely discussed provisions is that for the first time, federal regulations governing research with humans authorize the use of broad consent for future, unspecified research on individually identifiable biospecimens and associated data. Many questions have been raised about broad consent, including what effect it will have on research and whether it adequately protects the interests of research participants.There are lessons to be learned for the U.S. and other countries by looking to countries that already have experience with broad consent for biobank collection and with the storage and subsequent use of the biospecimens and data. This article describes how broad consent works in five countries—Canada (in Quebec), Israel, Nigeria, Taiwan, and the United Kingdom—and with different types of biobanks: national biobanks, federated biobanks, and regional biobanks. Evaluating the provisions and challenges of the broad consent approaches in these countries can inform policies for this increasingly used approach to biobank regulation.

An investigation into the future of discretionary trusts in South Africa: An income tax perspective: Part 2

Background: Trusts have long been used as an estate planning mechanism, including the avoidance of estate duty and donations tax. In the 2016 National Budget the Minister of Finance indicated that Government was proposing several legislative measures during 2016/2017 to prevent individuals from using a trust to avoid estate duty (and donations tax to a certain extent). Unexpectedly, the 2016 draft Taxation Laws Amendment Bill and the final Amendment Bill did not give effect to any of these proposals, but introduced other less drastic measures to control the abuse of trusts for tax purposes, albeit with the same stated purpose.Aim: The main aim of the study was to clarify the reform proposals (albeit unclear and consequently based on certain assumptions) and to compare the reform proposals with the final amendments. This comparison will shed some light on the fairness and appropriateness of the final amendments and, more importantly, on the possibility that the reform proposals published by National Treasury in February 2016 not included in the final amendments will be enacted in the future. This investigation will assist tax practitioners and taxpayers in effective tax and estate planning, given that the reform proposals and final amendments have a possible impact on the future of discretionary trusts in South Africa.Setting: This article examines existing literature in a South African income tax environment.Methods: In order to meet this objective a qualitative approach based on a literature study of pure theoretical aspects was used.Results and conclusion: It was found that should the reform proposals become law, many trusts would become ineffective from a tax-planning perspective and these changes might erode other benefits trusts offer, jeopardising the future of discretionary trusts in South Africa.

Single IRBs in Multisite Trials

On June 21, 2016, the US government announced changes that are arguably the most significant of the last quarter century concerning the protection of human research participants—a requirement for use of central or single institutional review boards (IRBs) in multisite National Institutes of Health (NIH)–funded research. Specifically, the NIH announced a new policy (effective September 25, 2017) to mandate that nonexempt multisite research with humans funded by the NIH be reviewed by a single IRB.1 On January 19, 2017, final amendments to the federal human research participant protection regulations (the Common Rule) were also published, requiring use of a single IRB,2 although implementation will be delayed until January 20, 2020. The NIH directive seems straightforward, but effective implementation will require that institutions, researchers, and policy makers decide how to address a number of critical issues. The Common Rule amendments explicitly recognize that further guidance will need to be developed, necessitating that these stakeholders confront several dilemmas.

Constitutionalizing Single Party Leadership in Vietnam: Dilemmas of Reform

AbstractThe supremacy of the Communist Party of Vietnam (CPV) has been the basic norm in Vietnam’s constitution since 1980. While it was not changed in the final constitutional amendments in 2013, thisgrundnormwas seriously debated during the constitutional reform process between 2010-2013, thus indicating a shift in the constitutional dialogue in Vietnam. This article traces the history of this basic norm throughout constitutional amendments of the Socialist Republic of Vietnam (SRV) and assesses how the basic norm has become increasingly contested. Contestations over this basic norm have played out markedly over the recent constitutional reform process. The discursive power in these contestations has shaken the rationality-based legitimacy of this basic norm to its root. The continuing dominance of this norm depends to a large extent on how the Vietnamese party-state’s practical policy-making and policy implementation initiatives address the increasing tension between the supremacy of the CPV and other principles in the constitution.

The European Parliament proposal for the new EU General Data Protection Regulation may severely restrict European epidemiological research.

In January 2012, the European Commission presented the draft of a new General Data Protection Regulation (GDPR) to the European Parliament and the Council of the European Union. The GDPR is planned to replace the 1995 Directive 95/46/EC, which constitutes the present European legal framework for processing of personal data. Hence, this new binding Regulation will lay the legal foundation for future European epidemiology based on personal data, including register-based research. The intentions behind the new GDPR are commendable: [1] to protect the fundamental rights and freedoms of individuals, in particular their right to protection of personal data, in a society where commercial enterprises and authorities have rapidly increasing capabilities to collect, store and combine personal information; and [2] to facilitate free movement of personal data within the European Union through a uniform legislation in all member states. The Commission’s proposal is being reviewed and amended independently by the Council of the European Union and the European Parliament. In the Parliament, the Committee on Civil Liberties, Justice and Home Affairs (LIBE) was assigned the task of formulating the Parliament’s amendments. The first draft by the chairman of the Committee, Jan Philipp Albrecht, was criticized for insufficient consideration to the needs of epidemiological research. The proposed text threatened to restrict currently existing possibilities to produce scientific evidence based on European data analysis and, in turn, to impede efforts to improve public health and welfare in the union and elsewhere. In October 2013, after a long period of negotiations surrounded by intense lobbying efforts, the LIBE Committee voted on its final amendments to the Commission’s proposal [1]. Alas, although some improvements were noted, the overall outcome was largely disappointing from an epidemiological perspective. The main points are summarized in the following. The first Articles with specific relevance for scientific research are concerned with general principles (Article 5) and lawfulness (Article 6) of personal data processing. Article 5b lays down that personal data shall be collected for specified, explicit and legitimate purposes and may not be further processed in a way incompatible with those purposes (“purpose limitation”). This corresponds to an identical principle in the current 95/46/EC Directive. However, in Directive 95/46/EC there was an exemption for research, namely that further processing of data for historical, statistical or scientific purposes is not to be considered as incompatible with the original purpose as long as Member States provide appropriate safeguards. This exemption was omitted in LIBE’s amendments, dramatically reducing the scope for data sharing between research groups and severely restraining the use of retrospective (historic) cohort study designs. Such studies utilize old data collections with exposure information that was collected for other purposes than the current scientific research. Thus, hundreds of thousands person-years of follow-up may have accumulated already at the start of the retrospective cohort study, making it possible to immediately test important public health hypotheses that would otherwise take decades to address. A typical example is the study of long-term health effects of Swedish snus (snuff) in an already existing cohort of construction workers [2]. If taken literally, the omission of the exemption threatens to eliminate the possibility to use administrative registers for epidemiological research altogether.

Further development of the response scales of the Acquired Brain Injury Challenge Assessment (ABI-CA)

Primary objective: To revise the scaling of the response sets of the Acquired Brain Injury Challenge Assessment (ABI-CA) through expert input and determination of empirically based cut-points.Research design: A measurement development study with a content validity focus.Methods: Response option wording was revised through consultation with six physiotherapists with paediatric ABI expertise. Twenty-nine typically-developing children performed the ABI-CA and empirically-based cut-points for item-specific response options were derived from their time/distance/repetition results (SD values) as benchmark values. Movement quality considerations (compensatory movements) were identified from expert consultation/ABI-CA video observation and built into revised response options. The revised ABI-CA was pilot-tested with four children with ABI, aged 7–15 years, for a feasibility check.Results: Nineteen of the 23 items’ response scales were revised based on experts’ feedback and empirically-based cut-points replaced the previous arbitrarily-determined cut-points. Compensatory movement considerations were re-defined in nine items. The mean score of the refined ABI-CA was 70.0% (SD = 18.5) with four children with ABI.Conclusion: The new response options in the ABI-CA appeared suitable for testing high-functioning children with ABI and the mid-range mean score in this pilot sample indicates its potential to measure change. Recommendations are outlined for final ABI-CA amendments before large-scale validation.

The Future of Fracking: New Rules Target Air Emissions for Cleaner Natural Gas Production

Natural gas is lauded as a cleaner-burning fuel than either coal or oil, but getting the fuel out of the ground can be a dirty process, especially given the widespread adoption of the technology known as hydraulic fracturing (“fracking”). Concerns about toxic air emissions from previously unregulated fracking sites led to the U.S. Environmental Protection Agency (EPA) announcement on 18 April 2012 of new and updated air pollution regulations for these facilities and certain other elements of oil and natural gas production and transmission.1 Compliance with the new regulations is expected to result in major reductions in emissions of methane and volatile organic compounds (VOCs), particularly from new fracked natural gas wells. The rules were a hot topic nationally, drawing more than 156,000 comments after the proposed version was released in mid-2011. Under the final rules, companies have until January 2015 to fully phase in the control measures needed; by comparison, the initial proposal called for a 60-day phase-in for many major requirements. The EPA says about half of all new wells already use the equipment needed to capture the targeted emissions.2 A hydraulic fracturing natural gas drilling rig on the eastern Colorado plains. In 2009 there were more than 38,000 natural gas wells in the state. Many environmental groups consider the new regulations an improvement over the existing situation, but they tend to be disappointed much more wasn’t done. “This is quite a milestone,” says Jeremy Nichols, Climate and Energy Program director for the advocacy group WildEarth Guardians, one of two groups that filed suit against the EPA in 2009 to force action on the issue. “But is the work done? No, of course not. It’s a floor to build on, providing a minimal level of protection.” The oil and natural gas industry has its own concerns about the new rules but has indicated it can work with them. In a press release issued the day the rules were announced, Howard Feldman, director of regulatory and scientific affairs for the American Petroleum Institute, said, “EPA has made some improvements in the rules that allow our companies to continue reducing emissions while producing the oil and natural gas our country needs.”3

All advisers to registered investment companies need to evaluate their exposure to CFTC regulation after recent rule amendment

Purpose – The purpose of this article is to explain the implications for registered fund advisors of the February 9, 2012 final amendments the Commodity Futures Trading Commission (CFTC) made to its Rule 4.5 exemption from commodity pool operator (CPO) registration for registered funds.Design/methodology/approach – This article explains how amended Rule 4.5 will be applied to advisors and sub‐advisors of registered investment companies and the managers of foreign corporations controlled by registered investment companies. The article also describes the expected impact of the CPO compliance regime under a proposed harmonization of CFTC CPO regulation with Securities and Exchange Commission regulation of registered fund advisers.Practical implications – All registered fund advisers should conduct a review of each of their registered funds' portfolios, investment strategies and marketing materials to evaluate their status as CPOs by the compliance deadline. Advisers who cannot comply with the amended Rule 4....

Emerging issues under interim final regulation on plan service provider fee disclosure

PurposeThe purpose of this paper is to describe interpretive and compliance issues arising under the Labor Department's interim final regulations under the statutory exemption for the provision of services provided by Section 408(b)(2) of ERISA, which will become effective on January 1, 2012.Design/methodology/approachThe paper analyzes the published interim final regulations and considers significant comments filed in response to the proposed regulations.FindingsEffective January 1, 2012, covered service providers who rely on the statutory exemption for the provision of services provided by Section 408(b)(2) must begin complying with the interim final amendments to the regulations under Section 408(b)(2) (the “Regulation”). Among other changes, the Regulation will require service providers to provide additional disclosures of direct and indirect compensation and to identify whether they expect that they will be providing services as a fiduciary or as a registered investment adviser. The primary purpose of the Regulation is to assist plan sponsors in evaluating service provider relationships, including total compensation that will be received by the service provider and conflicts of interests to which the service provider may be subject. The Regulation will apply to both new and existing service provider arrangements on January 1, 2012. Failure to comply with the Regulation may result in the assessment of excise taxes under Section 4975 of the Internal Revenue Code unless other exemptive relief is available. Service provider arrangements may be eligible for exemptive relief under certain other statutory and administrative exemptions.Originality/valueThe paper describes possible compliance issues that may arise under the Regulation and identifies and evaluates interpretive and compliance issues that have been noted since the proposed amendments were published.

Writing a British Association of Dermatologists clinical guideline: an update on the process and guidance for authors

Writing a British Association of Dermatologists clinical guideline: an update on the process and guidance for authors

A reforma da previdência no Brasil: estudo comparativo dos governos Fernando Henrique Cardoso e Lula

After reaching macroeconomic stability while privatizing state companies and implementing other first generation reforms, Brazil has tried to balance its fiscal budget by promoting a series of second generation reforms. The present paper discusses the political processes involved in one of the most critical of these, i.e. the reform of the pension system. By comparing the pension reforms enacted under Fernando Henrique Cardoso and Luiz Inacio Lula da Silva, we try to understand how actors, preferences, and strategies shaped the final amendments approved in 1998 and 2003, respectively. We conclude that institutions have been crucial elements in the characterization of winners (present civil servants) and losers (the overall population and the future civil servants).

Final Amendments to the Merger Directive: Avoidance of Economic Double Taxation and Application to Hybrid Entities, Two Conflicting Goals

Final Amendments to the Merger Directive: Avoidance of Economic Double Taxation and Application to Hybrid Entities, Two Conflicting Goals

Spatial and temporal patterns in final amendments to provisional disease counts.

This article examines temporal and spatial patterns in the relationship between provisional and amended reports for Hepatitis A and Hepatitis B received from each state by the Centers for Disease Control and Prevention through the U.S. National Notifiable Diseases Surveillance System from 1980 to 1992. It demonstrates that, as the 1980s unfolded, the preliminary disease reports became less representative markers of final disease counts. Practitioners at the state and community levels need to be aware of the temporal and spatial instabilities in such provisional data if they are used to provide early warning of contemporary health aberrations.