Registration Practices Research Articles

Evaluation of selective outcome reporting and trial registration practices among addiction clinical trials.

Selective outcome reporting occurs when trialists pre-specify primary and secondary outcomes during trial planning but alter the definitions in the published report. Here, we investigate selective outcome reporting in published addiction randomized controlled trials (RCTs) and evaluate whether particular funding sources are associated with an increased likelihood of selective outcome reporting. We conducted a cross-sectional study of published addiction clinical trials. A PubMed search was performed to identify RCTs in addiction journals from 2013 to 2017. Included studies used a randomized design to address one of the following topics: (1) drug, alcohol and tobacco addiction prevention, (2) stabilization following excessive use of a substance, (3) relapse prevention or (4) recovery maintenance. Single-center, medical research institution. Our sample included 162 RCTs that were prospectively registered with a clearly defined primary outcome. We extracted the following items from addiction RCTs: journal, funding source, trial registry number (if included), sample size, dates of subject enrollment, whether primary and secondary outcomes were denoted, all published outcomes, P-value for all outcomes and whether authors mentioned any deviations from the trial protocol as it related to RCT outcomes. In total, 47 of 162 RCTs (29.0%) had at least one major discrepancy between the trial registry and published RCT. Overall, these 47 RCTs included 54 major discrepancies. The most common major discrepancy was demotion of a primary registered outcome (19/54, 35.2%). The majority of RCTs (132/162, 81.5%) were funded from public sources. Additionally, 166 RCTs were excluded from our sample because registration could not be confirmed. There is evidence suggestive of selective outcome reporting in addiction randomized controlled trials (RCTs). The most common major discrepancies pertained to the primary outcome.

CONTRACTUAL REGISTRATION OF ORGANIZATIONAL AND LEGAL RELATIONS BETWEEN SUBJECTS INVOLVED IN THE CONDUCT OF CLINICAL TRIALS OF MEDICINAL PRODUCTS

The aim: Determination of features of contractual registration of organizational and legal relations between the subjects involved in carrying out clinical trials of medicinal products; justification of proposals on improvement of law enforcement practice in this field. Materials and methods: This research is based on the analysis of the norms of international law and legislation of particular states, practice of contractual registration of organizational and legal relations between the subjects of clinical trials of medicinal products. The research was carried out using the methods of dialectical and formal logic, general scientific and special legal research methods. Conclusions: Two models of contractual registration of organizational and legal relations between the subjects involved in clinical trials of medicinal products were justified, and law enforcement recommendations for the contractual registration of such relationships, ensuring that the clinical trial is in compliance with international regulations and ethics in this field, were given.

Повышение доступности и открытости информации по проводимым биомедицинским исследованиям в Республике Казахстан на основе разработки и запуска Национального регистра биомедицинских исследований: Аналитический обзор для формирования политики

What is the problem? • Lack of culture and legal grounds for providing open and full access to information on biomedical research (BMR) conducted in the territory of the Republic of Kazakhstan. • Lack of a unified on-line platform that provides the ability to search for specified parameters and extract information in full-text format and in an accessible language about completed and ongoing BMRs. • Low availability of information about BMR held in the territory of the Republic of Kazakhstan for the scientific and professional medical community, health policy makers and the population. Policy options Option 1. Creation of a legal basis for registration of BMR in a unified national register, providing open and full access to information about BMR held on the territory of the Republic of Kazakhstan, by: o Securing the requirement for mandatory registration of BMR in the National BMR Register in the regulatory legal acts, which determine the procedure for conducting BMR, preclinical trials (PCT) and clinical trials (CT) of drugs and medical devices; o Inclusion of the requirement for mandatory registration in the National BMR Register in contracts concluded with scientific, sociological and analytical performers in the field of health care; o The conclusion by the Ministry of Health of an agreement with the editors of scientific journals published in the territory of the Republic of Kazakhstan that all published results of BMR can be published when the BMR data is included in the National BMR Register and (or) an authoritative international register. o Elaboration of mechanisms for retrospective filling of the National BMR Register by organizations that conducted BMR in the last 10 years. Option 2. Development and launch of an online resource of the National BMR Register, which provides access for various groups of users and provides automation of the processes of registering BMR, search and analysis of information contained in the register by: o Creation of an online resource of the National BMR Register in accordance with the recommendations of the ICMJE, with filling in all data included in the authoritative registers of the CT (for example, ClinicalTrials.gov), PCT (for example, PreclinicalTrials.eu) and other registers of the BMR providing free (on state, Russian, English) and full-text access to all registered BMR; o Development of instructions for maintaining the National BMR Register, training modules on working with the register, conducting a wide information campaign among all interested parties; o Development of on-line platform for the Unified system for submitting applications for CT in integration with the National BMR Register (functioning on the principle of a “single window” for licensing procedures, information support, reporting, etc.); o The institutionalization of the mechanism of the Unified system for submitting applications for CTs by forming a Coordination Center for Clinical Trials and fixing a new mechanism for accepting applications in the Rules for conducting clinical trials of medicines and medical devices. • Option 3. Development of international cooperation in the field of BMR registration, by: o Submission of an application for the inclusion of the National BMR Register as a primary register in ICTRP (sending to WHO a profile and technical questionnaire, letters of support from the Ministry of Health of the Republic of Kazakhstan); o Ensuring regular transmission of data from the National BMR Register to ICTRP; o Development of the practice of registration of BMRs conducted on the territory of the Republic of Kazakhstan in international registries (ClinicalTrials.gov, PreclinicalTrials.eu, etc.). Vision on the implementation of policy options In assessing the feasibility of implementing the proposed policy options, taking into account the existing barriers and opportunities, we conclude that all three policy options complement each other. However, given the differences in options in the direction of actions, the resources and methods used, these policy options can give a more significant achievement of the goal of increasing the availability and openness of information on the conducted BMR in the Republic of Kazakhstan when they are combined.

Erken Modern Osmanlı İmparatorluğu’nda Devlet, Toprak ve Kayıt Pratikleri: 1670-1671 Edirne Tahriri Bize Ne Anlatır?

This article focuses on land and land registration in the post-classical period of the Ottoman Empire. Based on the 1670-71 Edirne Land Survey, it provides new information with regard to the transformation the Ottoman Empire was going through during the seventeenth century. The study aims to contribute to our current state of knowledge about the Ottoman administrative and fiscal registration practices. Furthermore, it intents to ask new questions regarding the changing nature of fiscal registers by comparing the Edirne Survey with the tax surveys of the classical period as well as with those prepared in the seventeenth century. Finally, by underlining how Ottomans used space as a measurable unit, it discusses the place of the changing perception of space vis-a-vis the changing administrative and fiscal needs. Keywords: Edirne, survey, survey register, land, measure, post-classical period.

A educação permanente como instrumento para a gestão da informação em atenção básica de saúde

Objetiva-se descrever o processo de trabalho dos profissionais da Atenção Básica, no que se refere à produção e utilização dos registros em saúde, e discutir a importância da gestão da informação em saúde e sua relevância para a qualidade dos registros de enfermagem. Trata-se de um estudo descritivo-exploratório, com abordagem qualitativa, pesquisa de campo com análise documental, que teve como cenário, três Centros Municipais de saúde localizados no municípiodo Rio de Janeiro, RJ. Brasil. Os participantes foram doze profissionais de enfermagem em atividade nestas unidades. O referencial teórico está baseado no conceito de uma prática reflexiva defendido por Donald Schön, que enfatiza ainstrução e a aprendizagem, através do fazer, sendo os dados analisados a partir das dimensões para análise e atributos para gestão da qualidade da informação propostos por De Sordi. Três categorias emergiram do estudo, as quais foramanaliticamente denominadas de: A prática do registro no ”fazer” da enfermagem, A qualidade do registro no pensar da enfermagem e Os registros de enfermagem no contexto da gestão da informação em saúde. Conclui-se a necessidadede investir em estratégias de educação permanente, visando promover o desenvolvimento da responsabilidade intelectual e, consequentemente, o aprimoramento da prática de registrar em enfermagem

Making space legible across three normative frames: The (non-)registration of inherited land in Ghana

Land registration as a state legibility making endeavor has received little success in the global south where large incidence of non-registration has been reported. However, in seeking explanations for the lack of official land rights registration, researchers tend to focus on shortcomings in the bureaucratic processes based on expectations that are implicitly informed by a Weberian ideal bureaucracy. Little connection is made to other relevant factors that play different roles in the land registration processes such as the external socio-cultural norms which produces and regulate land relations. It is therefore important to study the actual practices of land rights registration and the underlying norms that govern such practices. In this study, we qualitatively analyze the actual practices of registration at the intersection of three normative frames, namely, social norms, practical norms and official norms. We used these normative frames as a theoretical prism to analyze how the choices made by successors of inherited property across rural and urban areas in Ghana are informed, given the plural normative influences. We found that beyond organisational inefficiencies, the eventual decision of a successor of property to report transfers for registration depends on the nature of property claims (competing or complimentary), the manner of property sharing and holding, and the existence of ‘halfway-documents’ that provide some sort of legitimacy. Therefore, there is not one set of obstacles to registration, which would call for one set of solutions, instead, we need to appreciate the diverse nature of the factors that play roles in land registration in order to provide fit-for-purpose solutions.

Survival trends for primary liver cancer, 1995–2009: analysis of individual data for 578,740 patients from 187 population-based registries in 36 countries (CONCORD-2)

Background: Primary liver cancer is the fifth most common cancer world-wide, and the second most common cause of death from cancer, with an estimated 841,100 new cases and 781,500 deaths each year. Hepatocellular carcinoma (HCC) accounts for 60–80% of cases, and cholangiocarcinoma 10–40%. We examined global trends in survival for both these sub-types of liver cancer, by country, age, sex and calendar period. Methods: Data on 1,005,032 adults (aged 15–99 years) diagnosed with a primary, invasive malignant neoplasm of the liver or intrahepatic bile ducts between 1995 and 2009 were provided by 243 population-based cancer registries in 60 countries. Analysis was restricted to patients for whom the diagnosis of a primary malignancy had been confirmed by histological or cytological examination, or assignation of a specific morphology code, and to registries from which survival estimates were considered reliable. We estimated both five-year net survival and conditional five-year net survival, for patients who survived to the first anniversary of diagnosis. Funnel plots were used to examine international variation in survival and variation by age and morphology. Results: Data on 578,740 patients from 187 registries in 36 countries were included after quality control. For patients diagnosed during 2004–2009, the pooled estimate of age-standardised five-year net survival for liver cancer was 14.8% (range, 4.4–23.7%), higher than for patients diagnosed during 1995–2000 (11.0%). Survival for patients diagnosed with HCC during 2004–2009 (pooled estimate 17.4%, range 7.7–25.5%) was higher than for those with cholangiocarcinoma (8.4%, range 3.7–16.0%). Survival for patients diagnosed during 2004–2009 was higher in Canada, Italy, Japan, Taiwan and Korea (21.2–23.7%) than the pooled estimate for patients diagnosed some 10 years earlier (1995–2000; 11.0%). Conditional survival in 2004–2009 was also higher in New Zealand, Canada, Taiwan, Korea, and China (42.0–52.7%) than the pooled estimate for 1995–2000 (33.2%). Conclusions: Survival from primary cancers of the liver has increased, but it remains poor in most countries we have examined. International variation in survival highlights the potential to improve outcomes, but prevention must also remain a priority. There is a need for continued and expanded surveillance of survival, especially in low- and middle-income countries, to assess the impact of interventions in policy and treatment. Greater consistency in registration practice and coding of liver cancer would reduce the variation in data quality and further improve the comparability of survival estimates.

Genetic Algorithm based Optimized Image Registration using Fast Walsh Hadamard Transform

Numerous medical means are mandatory with accuracy and totality of data about a patient for a doctor for healthcare predictive analytics and so as to treat and take care of their patients’ remedy. Medical image registration practices bestow more affluent diagnosis and medication information to the doctors in stipulating an all-embracing allusion resource for the beneficiaries entangled in image registration as an optimization crisis. In this research work, optimization of theGenetic Algorithm based image registration technique using Fast Walsh Hadamard Transform was implemented and their evaluation of results proved to be good.

Standards Setting Organizations and Trademark Registration: An Empirical Analysis

The paper presents an empirical analysis of the trademark registration practices of 40 standards setting organizations. Key observations and conclusions include: (a) every organization had submitted a registration application with the USPTO, and all but four had active registered marks, suggesting that trademarks play an important role for SSOs; (b) nearly all SSOs appear to be emphasizing their organization name as a de facto “house mark” (although none appear to formally apply for “house mark” status with the USPTO); (c) classes 9, 35 and 42 appear to be particularly important for SSOs – and the dominance of class 9 suggests that software is playing a key role in standardization; (d) despite frequently engaging in “certification,” SSOs infrequently rely on certification marks; (e) SSOs appear to make little use of collective membership marks; and (e) SSOs display a striking diversity of approaches to trademark registration.

Ill-Protected Portraits: Mathew Brady and Photographic Copyright

ABSTRACTThis article focuses on Mathew Brady’s attempts to use copyright to protect his photographs. For a time, Brady received so much credit in the press that his name became synonymous with all photographs of the Civil War. This prominence in the photography trade and in the public imagination makes Brady’s use of copyright an ideal case for considering the relationship between photography and authorship. The research of this study cites relevant archival sources, including copyright registration practices, copyright notices on printed photographs, and the case of Brady & Gibson v. Bellew (1865), to demonstrate deliberate attempts by Brady to protect his work from infringement, secure economic compensation, and link his name legally with the images he believed would have enduring value. While copyright ultimately failed to protect Brady’s long-term financial interests, part of his attribution strategy established him as a photographic “author” and ensured that his name would remain linked with his photographs.

Impact of variation in cancer registration practice on observed international cancer survival differences between International Cancer Benchmarking Partnership (ICBP) jurisdictions

BackgroundInternational cancer survival comparisons use cancer registration data to report cancer survival, which informs the development of cancer policy and practice. Studies like the International Cancer Benchmarking Partnership (ICBP) have a duty to understand how registration differences impact on survival prior to drawing conclusions. MethodsKey informants reported differences in registration practice for capturing incidence date, death certificate case handling and registration of multiple primary tumours. Sensitivity analyses estimated their impact on one-year survival using baseline and supplementary cancer registration data from England and Sweden. ResultsVariations in registration practice accounted for up to a 7.3 percentage point difference between unadjusted (estimates from previous ICBP survival data) and adjusted (estimates recalculated accounting for registration differences) one-year survival, depending on tumour site and jurisdiction.One-year survival estimates for four jurisdictions were affected by adjustment: New South Wales, Norway, Ontario, Sweden. Sweden and Ontario’s survival reduced after adjustment, yet they remained the jurisdictions with the highest survival for breast and ovarian cancer respectively. Sweden had the highest unadjusted lung cancer survival of 43.6% which was adjusted to 39.0% leaving Victoria and Manitoba with the highest estimate at 42.7%. For colorectal cancer, Victoria’s highest survival of 85.1% remained unchanged after adjustment. ConclusionPopulation-based cancer survival comparisons can be subject to registration biases that may impact the reported ‘survival gap’ between populations. Efforts should be made to apply consistent registration practices internationally. In the meantime, survival comparison studies should provide acknowledgement of or adjustment for the registration biases that may affect their conclusions.

Of flesh and bone: emotional and affective ethnography of forensic anthropology practices amidst an armed conflict

ABSTRACTAs I set out to write about my research process with forensic anthropologists in a country with a long-lasting armed conflict, I was unable to ignore the imminent role that affect and emotions play in my practice and in my relationship with this topic. I fought the urge to disregard the struggle implied in writing about my own practice. Thus, I reflect on the effects and affects that this fieldwork and its related methods have on my approach to this topic, to the people I work and share with, and to myself. My argument is twofold. First, if one is to acknowledge that affect and emotions produce knowledge and that knowledge productions have world-making effects, as researchers we need to attend to the worlds we enact through our own research and knowledge production practices. Second, writing and registration practices constitute modes of research that, in themselves, produce knowledge. I develop my argument in three steps. I reflect on the difficulties of writing this particular text; I address my own knowledge productions – that include my own registration practices, and I attend to the worlds that I help to enact. I also pay attention to others’ registration practices.

So You Think Digital Is the Future. Your Internet Data Are Rotting

Civil registration practice usually requires records to be kept for a very long time, or even in perpetuity. Digitization has raised the matter of the (non-)longevity of digital records because of frequent, ongoing changes in hard-and software. This has not been on the radar of the enthusiasts of digital ID. It is not-for example-addressed in the World Bank-initiated 'Principles on Identification' (endorsed by more than two dozen other organizations). Record management has been identified as a vulnerability of the Aadhaar system in India in which more than a billion people have been enrolled. The currently boisterous expectations re digital ID threaten to negatively impact civil registration, including its irreplaceable legal purpose and the importance of the preservation of records of legal identity. The article concludes with an illustration using a World Bank-funded project for Tonga, the Pacific Island country with just over 100,000 inhabitants.

Geographical Indications Protection Under The New Regulation In Indonesia

Since Geographical Indications are set out in the TRIPs Agreement, Indonesia as a member of the WTO has established a regulation on Geographical Indications in national law. The regulation of Geographical Indications for the first time stipulated in Law of the Republic of Indonesia Number 14 of 1997 concerning Trade Mark. After several changes, finally Law of the Republic of Indonesia Number 20 of 2016 concerning Trade Mark and Geographical Indications superseded the previous trade mark law. The title of this statute separates the term between trade mark and geographical indications, is it correct? This paper examines the normative provisions on geographical indications in that statute and examines the practice of registration of geographical indications product which is originating from Lampung Province. The result shows that there are not so many changes which are regulated by the new Indonesian Trade Mark Law and moreover in the process of registering Geographical Indications are still associated to the registrations of trade mark. The practice of geographical indications registrations are taken a long time and complicated.

Improving immunization data quality in Peru and Mexico: Two case studies highlighting challenges and lessons learned

IntroductionThe Global Vaccine Action Plan and the Regional Immunization Action Plan of the Americas call for countries to improve immunization data quality. Immunization information systems, particularly electronic immunization registries (EIRs), can help to facilitate program management and increase coverage. However, little is known about efforts to develop and implement such systems in low- and middle-income countries. We present the experiences of Mexico and Peru in implementing EIRs. MethodsWe conducted case studies of an EIR in Mexico and of a population registry in Peru. Information was gathered from technical documents, stakeholder focus groups, site visits, and semi-structured interviews of national stakeholders. We organized findings into narratives that emphasized challenges and lessons learned. ResultsMexico built one of the world’s first EIRs, incorporating novel features such as local-level tracking of patients; however, insufficient resources and poor data registration practices led to the system’s discontinuation. Peru created an information system to improve affiliation to social programs, including the immunization program and quality of demographic data. Mexico’s experience highlights lessons in failed sustainability of an EIR and a laudable effort to reform a country’s information system. Peru’s demonstrates that attempts to improve health and other data may strengthen health systems, including immunization data. Major challenges in information system implementation and sustainability in Peru and Mexico related to funding, clear governance structures, and resistance among health workers. DiscussionThese case studies reinforce the need for countries to ensure adequate funding, plans for sustainability, and health worker capacity-building activities before implementing EIRs. They also suggest new approaches to implementation, including economic incentives for sub-national administrative levels and opportunities to link efforts to improve immunization data with other health and political priorities. More information on best practices is needed to ensure the successful adoption and sustainability of immunization registries in low- and middle-income countries.

(Re)producing Statelessness via Indirect Gender Discrimination: Descendants of Haitian Migrants in the Dominican Republic

AbstractGender discrimination as a risk factor for statelessness has been understood as direct discrimination whereby legal frameworks prohibit mothers from conferring their nationality. This article discusses research findings from the Dominican Republic where indirect gender discrimination, evident in documentation and birth registration practices applicable to Haitian migrants and descendants, is causing matrilineal transmission of statelessness. Restricting access to citizenship has become a form of migration control, just as the creation of temporary, ad hoc status forms allows the state to sidestep responsibilities for migrant incorporation. If the links between gender and statelessness are not only legal, but also historical, structural, and procedural, then disrupting this cycle requires more than legal reform. For advocacy campaigns, such as UNHCR's #IBelong Campaign and the Global Campaign for Equal Nationality Rights, to be successful, they must adopt a broader interpretation of the relationship between gender and statelessness, based on CEDAW's substantive conception of gender equality.

PELAKSANAAN PELAYANAN OLEH TENAGA KEFARMASIAN BERDASARKAN PERATURAN MENTERI KESEHATAN REPUBLIK INDONESIA NOMOR 30 TAHUN 2014 TENTANG STANDAR PELAYANAN KEFARMASIAN DI PUSKESMAS (Studi di Puskesmas Kabupaten Purbalingga)

Pharmaceutical service is an integrated activity with a view to identifying, preventing, and resolving drug related issues. Limited number of pharmacist, misappropriation of drugs, availability of drugs and legal certainty of contract pharmacist are inhibiting factors of pharmaceutical services at Public Health Center. This research is in the form of juridical normative-empirical by using secondary and primary data. Secondary data source from library study as secondary legal materials and primary data source from observation and interview as primary legal material. The results showed pharmacist is responsible for pharmaceutical services in Public Health Center, both clinical pharmacy and drug management. Drug shortages occur because the stock is empty from district health office and the presence of expired drugs comes from provincial stock buffer. Technical implementation of pharmaceutical service using guidelines in accordance with legislation. Appointment of contract worker by unauthorized persons caused administrative violations. Registration certificate and practice license are the basic of legal certainty for pharmacist.

Facilitating Transactions and Lawful Availability of Works of Authorship: The U.S. Perspective

As Associate Register of Copyrights and Director of Registration Policy and Practice at the United States Copyright Office, a significant part of my role is to be an advocate for formalities within the limits of the Berne Convention. I realize that many view registration, recordation, and other formalities as obstacles to authors. However, such formalities need not be impediments, but rather may offer valuable benefits to authors, owners, and the overall copyright ecosystem without unduly burdening creators.

Marriage Registration among Palestinians and Syrians in Jordan

Based on long-term fieldwork in Jordan, this paper discusses two marriage registration practices that have become topics of public debate and locus for intervention projects of development organizations: the early registration of marriages among Palestinian camp residents, and the non-registration of marriages among Syrian refugees. This paper shows how the narratives around marriage registration play a role in the production of identity and senses of belonging and provides insight into the overlaps and gaps between the discourses of development organizations and the concerns of those involved in these practices. In the Palestinian case, the early registration of marriage provides the couple with a limited but important space to get acquainted before the wedding. Women’s organizations and NGOs, however, often blame this practice for the increase in divorce rates before consummation. In the Syrian case, organizations focus on the negative legal and social consequences of not registering a marriage with the state, while conversations with Syrians reveal the obstacles they face while navigating the Jordanian legal system and their need to legitimize their non-registration of marriages.

Quality assurance in melanoma care: The EU-MELACARE study

BackgroundA significant disparity regarding survival outcome for melanoma among European regions is well recognized and access to high quality care for European melanoma patients needs to be improved. There is an unmet need for the implementation of minimal standard of care within defined clinical pathways and Quality Assurance (QA) indicators. ObjectiveThe EU-MELACARE study aims to identify shared variables for cutaneous melanoma cases recorded in melanoma registries across Europe. Material and methodsOpinion leaders involved in melanoma data registration and care quality analysis in 34 European countries were invited to respond to an expert survey covering questions regarding the melanoma registration practice in their countries and the characteristics, coverage and variables collected by the relevant melanoma registries. ResultsData regarding 13 melanoma registries from 11 European countries contributed to the study. The majority (61,5%) were population based registries and more than half (62%) had national coverage. The included registries collected a median of 38 variables (Interquartile Range, IRQ 21–76). We identified 24 shared variables available in >70% of registries. ConclusionsThis study provides valuable specific information on information recorded for melanoma cases are registered within Europe. A core of shared variables has been identified, which will constitute the basis for a standardized set of QA indicators for assessing and monitoring melanoma care across European countries.