Street-level Research on Street-level Interventions Among Drug Users: Commentary on Papers by Frank et al., Hayashi et al., Small et al., and Domanico and Malta

The purpose of this study is to describe the publication characteristics associated with therapeutic community research and illustrate differences between addiction studies and other types of therapeutic community papers. A total of 223 published reports on research pertaining to the therapeutic community in a variety of treatment settings from 1987 to 1992 were analyzed. The articles consisted mainly of addiction studies (38%) and hospital psychiatry (36%) studies. Collaborative authorship was scanty. Quantitative studies (systematic data presented and analyzed statistically) were performed more often in addiction papers than in psychiatric therapeutic community papers. Addiction studies were also cited slightly more often. Addictions are often a rather simple and distinct focus for research, as well as a major public health problem. This may lead to the smoother use of traditional quantitative research strategies and standard publication channels than in other psychiatric therapeutic community studies.     

An Ethics-based Approach to Research in Global Health: A Call to Action for Pharmacists

As opportunities and interests in international partnerships and research continue to grow in pharmacy, so, too, does the likelihood of encountering ethical challenges. We posit that the chance of encountering an ethical challenge in global health is almost inevitable. This commentary serves as an introduction to a series of four papers highlighting ethical issues in global health research for pharmacists. The authors draw on core ethical principles to guide collaborative global research in working to advance the health of people and populations worldwide.     

Women as first authors in key pharmacy journals: Analysis by publication type

BackgroundNumerous national and international studies have explored the issue of gender disparity in health science–publication rates. However, few have examined publication type (e.g., reviews and original research) and authorship order, which are 2 key factors in contribution recognition and the work’s visibility and application.ObjectiveThe objective of this work was to determine the changes in the distribution of women as first authors by publication type over time in pharmacy practice journals.MethodsThis was a bibliometric data analysis of pharmacy practice publications from January 2007 through December 2017. We used data from the U.S. Social Security Administration, and the multilingual Genderize application program interface (Genderize.io) to identify the authors’ potential gender. To determine the publication type, we used the Web of Science article list (Clarivate Analytics, Philadelphia, PA). The Cochran-Armitage trend test was used to determine the differences over time.ResultsArticles published from January 2007 through December 2017 in 8 pharmacy practice journals were reviewed (N = 14,658 articles): research articles (63.8%), reviews (17.0%), editorial material (11.1%), and letters (8.1%). There was a statistically significant increase in the number of first-authored articles and reviews by women (45.1% to 55.4% and 39.2% to 56.1%, respectively). There was not a significant increase in the proportion of women as first authors in editorials or letters over the study period.ConclusionDespite increases in research and reviews with women as first authors, there is still a need for increased representation of women in opinion-based publications such as editorials.     

Be positive about negatives–recommendations for the publication of negative (or null) results

Both positive and negative (null or neutral) results are essential for the progress of science and its self-correcting nature. However, there is general reluctance to publish negative results, and this may be due a range of factors (e.g., the widely held perception that negative results are more difficult to publish, the preference to publish positive findings that are more likely to generate citations and funding for additional research). It is particularly challenging to disclose negative results that are not consistent with previously published positive data, especially if the initial publication appeared in a high impact journal. Ideally, there should be both incentives and support to reduce the costs associated with investing efforts into preparing publications with negative results. We describe here a set of criteria that can help scientists, reviewers and editors to publish technically sound, scientifically high-impact negative (or null) results originating from rigorously designed and executed studies. Proposed criteria emphasize the importance of collaborative efforts and communication among scientists (also including the authors of original publications with positive results).     

Reducing avoidable medication-related harm: What will it take?

Consumption of quality-assured medicines is expected to maintain or improve population health. Yet in a number of situations, what is realized is lower health benefits or magnified safety risks. Recognizing the public health implications of safety risks or medication-related harm, and that some types of harm are avoidable, the World Health Organization has initiated the third Global Patient Safety challenge on Medication Safety. Under the term “Medication Without Harm”, this Challenge aims to assess the scope and nature of avoidable medication-related harm, create a framework for intervention and develop national guidance and tools to support safer medication use. The global target under the Challenge is to reduce the level of severe avoidable medication-related harm by 50% over a five-year period or within the next five years. Given a higher morbidity and mortality due to medication-related harm in low-income countries, this paper evaluates what needs to be done in low-income countries in order to achieve the global target. The ideal solution advocated requires that health planners in each low-income country determine what fraction of safety risks or harm can be prevented; and the relationship between number or frequency of avoidable harm or safety risks and the resource costs of treatment or prevention. In the absence of such information, this paper discusses a number of prevention strategies that might help; arguing that the period over which avoidable medication-related harm can be reduced by 50% will depend on whether significant continuous investments in health-system strengthening are made prior to and within that period.     

临床试验的伦理审查:妇女和孕妇

孕妇以及育龄期妇女参加临床试验,涉及她们本人、妊娠、胎儿和由胎儿长成的人、以及她们生育力的风险和受益,伦理委员会审查时需要有一些特殊的考虑.涉及妇女临床研究的特殊伦理审查问题主要包括：研究期间有怀孕的可能,其本身不能作为排除或限制育龄期妇女参加生物医学研究的理由;详尽讨论研究对孕妇和胎儿的风险,是妇女做出参加临床研究理性决定的先决条件;涉及孕妇临床研究的特殊伦理审查问题主要包括：风险和受益的判断应同时考虑研究对孕妇及胎儿两方面的风险与受益,并结合研究的类别进行考虑;只有当研究是针对孕妇或胎儿特有的健康需要,或针对孕妇总体的健康需要,并且如果合适,有来自动物实验、尤其是关于致畸和致突变风险的可靠证据予以支持,才能在孕妇群体中实施研究.     

Benefits and burdens of placebos in psychiatric research

Rationale The debate over the use of placebos in clinical trials when proven treatments exist continues to be lively, especially in psychiatric research. Current practice permits placebos in such settings, as long as the benefits outweigh the risks and burdens. Objectives To examine in depth the risk–benefit framework typically used to justify placebo controls in psychiatric drug development, by making explicit the implicit ethical tradeoffs. Methods Analysis informed by a review of currently available data on the benefits and burdens of exposing psychiatric research subjects to placebos. Results Various risk/burden thresholds for limiting placebo controls have been proposed, ranging from the currently used standards of no increased mortality or permanent morbidity to more recent proposals of 'serious but reversible harm' and 'severe discomfort.' Placebo exposure in antidepressant and antipsychotic trials appears not to increase mortality by suicide. Direct data on long-term effects are lacking. Symptom-related burdens of placebos need to be better quantified and more integrated into the ethical analysis of placebos. While the perspective of those who benefit from the practice of using placebo controls is well represented, virtually no data from the perspective of potential subjects exist. Conclusions The ethical analysis of placebos in psychiatric research has an important but limited evidence base. Suggestions for areas of further inquiry to increase that evidence base are given.     

Is selective reporting of clinical research unethical as well as unscientific?

BACKGROUND: Studies that do not confirm their prior hypotheses, otherwise called "negative" studies, receive less interest from different parties including authors, editors and sponsors, and so, not to publish such studies is a common phenomenon. Opinions differ on whether or not this phenomenon introduces imprecision into the assessment of health research and care. OBJECTIVE: The current paper gives arguments against and in favor of publishing "negative" trials, and tries to give suggestions for a more balanced approach to this problem. RESULTS: Arguments against publishing "negative" trials include: we need not publish erroneously "negative" trials; we need not publish a "negative" study out of worry that the favored treatment is inferior; full-length reports of "negative" trials devaluate the quality of literature, because the data are usually not so important, and generally receive little interest from readers, and so, not to publish them is a more or less "natural" matter of course. Arguments in favor of publishing "negative" trials include: no report reduces the flow of information because "negative" trials provide at least some evidence and balance against the overwhelming power of positive data readily accepted for publication; no report violates the promise to patient participants; studies that do not confirm prior hypotheses are especially important; not-publishing leads to unnecessary repetition of research. Initially, trials were frequently "negative" not only due to lack of power but also due to inappropriate hypotheses and poor designs. Currently, this is less so, and the issue of selective reporting, therefore, needs to be reassessed. Suggestions for a more balanced approach to the problem of selective reporting might include: careful planning before the trial begins, reduces the chance of biased and erroneously "negative" trials; any trial, "positive" or "negative", provides probabilities rather than truths; this notion does not explain away publication bias but does make it less of a problem; "negative" trials may not be appropriate for general journals but very relevant to specialist journals as well as other organs of specialist groups; ethical committees and trial review boards should address the issue of publishing as part of their function. CONCLUSION: Data from properly executed trials should routinely be made available. However, we should not forget that the empirical observations provided by clinical trials, are statistically tested, and that statistics are based merely on probabilities. It means that we must consider a more philosophical attitude to clinical trial evidence in terms of acceptance that scientific truths are rarely absolute.     

Which studies of therapy merit credence? Vitamin E and estrogen therapy as cautionary examples

A vast and continuously growing amount of material on drugs exists in the literature to read and evaluate. Frequently, the papers and their recommendations are conflicting and contradictory. Readers are faced with the dilemma of deciding what to believe. The need for evidence-based medicine as a foundation for optimal clinical research and patient care requires application of the best scientific methods. Various methods are discussed. Generally, the most powerful method to test a clinical hypothesis is the randomized, controlled clinical trial. By contrast, epidemiology/observation studies have certain inherent weaknesses that can lead to erroneous conclusions. The examples of estrogen therapy in postmenopausal women and of vitamin E therapy to reduce cardiovascular risk are discussed extensively to provide historical perspective and to demonstrate erroneous conclusions reached using epidemiology/observation studies. The sociology of journal publication is briefly described, and an attempt is made to assess who benefits and who is harmed when leading medical journals publish erroneous results. Types of bias and confounding issues leading to errors are discussed, and the need is emphasized for publication of rigorous studies after careful evaluation by editors to avoid repetition of past mistakes and to ensure publication of correct medical information.     

Prescribing of hormone therapy for menopause,tibolone, and bisphosphonates in women in the UK between 1991 and 2005

Objective The purpose of this study was to examine recent trends in the prescribing of hormone therapy for menopause, tibolone, and bisphosphonate preparations for the prevention or treatment of osteoporosis, in the UK in relation to publication of research evidence on the health effects of hormone therapy and subsequent changes in prescribing advice. Methods Individual patient-level data were obtained on the prescribing of hormone therapy, tibolone, and bisphosphonates by general practitioners in the UK between 1991 and 2005 to women aged 40 years and older in the UK General Practice Research Database. Overall and age-specific prescribing prevalence were calculated for each therapy type. Prescribing prevalence was also calculated for subcategories of hormone therapy and bisphosphonates. Results Prescribing of hormone therapy to women aged 40 years and older increased between 1991 and 1996 and remained fairly stable between 1997 and 2001. Hormone therapy prescribing has fallen by about 50% since 2002. Tibolone, a selective tissue estrogenic activity regulator, is prescribed much less commonly than hormone therapy but shows a similar pattern. Prescribing of bisphosphonates increased rapidly throughout the study period, particularly in women aged 70 years and older, with the pattern of prescribing reflecting to some extent, the availability of new weekly formulations. Conclusions Trends in the prescribing of hormone therapy in the UK appear to closely reflect new epidemiological evidence and prescribing advice. It is likely that the substantial fall in hormone therapy and tibolone prescribing seen since 2002 is a direct consequence of the publication of Women’s Health Initiative trial results and subsequent changes in advice given by the Committee on Safety of Medicines. The 1997 publication of results from the Collaborative Group on Hormonal Factors in Breast Cancer and 2003 publication of the Million Women Study findings may also have impacted on trends, particularly within certain age groups. The substantial and continuing increase in prescribing prevalence of bisphosphonates reinforces the need for research into the long-term risks and benefits of these therapies.     

Challenges and opportunities in conducting health services research through international collaborations: A review of personal experiences

There is increasing attention to international collaborations in health services research with a number of benefits. For developing and nurturing international collaboration, a growing number of funding opportunities are available globally. Having observed and experienced the growth of international collaborations in the global health research field, the authors reflect upon their own experiences in international collaboration between the United Kingdom and many different countries in the process of health services and educational research and discuss challenges and opportunities to conduct impactful research in international settings. The commentary also highlights key issues and strategies for learning and achieving more impact from global health research, including: communication, co-creation, strong leadership and sustainability.     

Perceptions of Risk in Research Participation Among Underserved Minority Drug Users

Research with underserved minority drug users is essential to quality health care and prevention. Understanding how participants perceive risk in research is necessary to inform research regulators so that research protections are neither lax, exposing participants to harm, nor overly stringent, thereby denying access to beneficial research. Data from 37 semistructured interviews of underserved, African-American crack cocaine users, collected from February to May 2006 in a large, urban setting, were analyzed using content analysis. In three hypothetical studies, participants recognized risks as relative and articulated and evaluated specific risks. Research regulators may enhance the accuracy of risk assessment in research by incorporating the views of participants. Study implications and limitations are noted. Future research on risk perception in research participation is suggested.     

Trends in authorship characteristics and collaboration in pharmacy practice publications: 2011–2020

BackgroundResearch and scholarly publications are core expectations in academia that often require collaboration. While the number of authors per document (NAPD) has increased in every discipline, co-authorship culture and collaboration patterns vary among disciplines and countries.ObjectivesTo determine the trends in the patterns and characteristics of authorship and collaborations in United States’ pharmacy practice faculty publications from 2011 to 2020.MethodsSeven pharmacy practice journals were selected based on previous studies and data from Scimago Journal and Country Rank. Articles and reviews (document types) published during the decade were obtained from the Scopus database. Data cleaning and analysis were done using Microsoft Excel, R programming language packages, and VOSviewer. The Mann-Kendall trend test was used to determine the presence of (positive/negative) monotonic trends.ResultsEight thousand and fifty-nine documents published in the selected journals (82.7% articles; 17.3% reviews) by 18,575 unique authors during the decade were analyzed. In most documents (69.3–78.7%), senior/corresponding authors were first authors. There were statistically significant upward trends in the mean NAPD (3.8 ± 2.2 to 4.7 ± 2.4), median NAPD, and related bibliometric indices (degree of collaboration, collaborative index, and collaborative coefficient). Conversely, productivity (document per unique author) significantly trended downward and had a strong, negative correlation with mean NAPD. The proportion of one-author publications also trended downward (12.2%–3.6%). Evidence also supports a downward trend in institutional collaboration and an upward trend in international collaboration.ConclusionsThe assumption that last authors are senior authors does not hold in pharmacy practice publications. The increase in NAPD is not considered as authorship inflation, but rather an authorship “upcreep” that is driven by a survival strategy to publish together, predominantly within institutions rather than across institutions or countries. Therefore, faculty publication benchmarks should be crafted to mitigate the inverse relationship between collaboration and productivity, without discouraging collaboration.     

An appeal for the presentation of detailed human derived data for dose–response calculations in nutritional science

If a diet, food or food constituent is recognised to have both health benefits and health risks, the benefits have to be compared with the risks to develop coherent scientific evidence-based dietary advice. This means that both risk and benefit assessment should follow a similar paradigm and that benefits and risks are expressed in a common currency. Dose–response functions are vital for that purpose. However, the construction of these functions is often of second interest in the currently available (epidemiological) literature. In order to bring forward the potential of epidemiological studies for the construction of the dose–response functions for benefit–risk purposes, the scientific (nutrition and health) community is asked to expand on their data presentation, either by presenting more detailed data focusing on dose–response necessities, and/or by sharing primary data.     

The history of the Central African Journal of Medicine 1953 to 1999

The Central African Journal of Medicine Company was founded in 1953 and registered in 1954 in accordance with the then existing company act. Its purpose was to assist medical personnel in central Africa find a place to publish the results of their research endeavours as well as an avenue to disseminate their clinical observation and updates. Since its first publication 46 years ago, to the present, the journal has attracted research papers from as far afield as Nigeria in West Africa, China, Hong Kong, the middle east and all the SADC states.     

What Becomes of Nuclear Risk Assessment in Light of Radiation Hormesis?

A nuclear probabilistic risk or safety assessment (PRA or PSA) is a scientific calculation that uses assumptions and models to determine the likelihood of plant or fuel repository failures and the corresponding releases of radioactivity. Estimated radiation doses to the surrounding population are linked inappropriately to risks of cancer death and congenital malformations. Even though PRAs use very pessimistic assumptions, they demonstrate that nuclear power plants and fuel repositories are very safe compared with the health risks of other generating options or other risks that people readily accept. Because of the frightening negative images and the exaggerated safety and health concerns that are communicated, many people judge nuclear risks to be unacceptable and do not favour nuclear plants. Large-scale tests and experience with nuclear accidents demonstrate that even severe accidents expose the public to only low doses of radiation, and a century of research has demonstrated that such exposures are beneficial to health. A scientific basis for this phenomenon now exists. PRAs are valuable tools for improving plant designs, but if nuclear power is to play a significant role in meeting future energy needs, we must communicate its many real benefits and dispel the negative images formed by unscientific extrapolations of harmful effects at high doses.     

An Ethics-based approach to Global Health Research Part 3: Emphasis on Partnership Funding

Acquiring funding for global health research within pharmacy can be challenging, particularly for new investigators who may have a strong interest in resolving global dilemmas related to health. Moreover, there can be inherent imbalances and ethical issues when navigating the funding process for global partnerships. There exists a lack of literature providing ethical guidance for mitigating dilemmas that may arise. This commentary discusses current funding streams for investigators interested in global pharmacy research, as well as specific recommendations for the funding process. These recommendations include managing award funds, ethical considerations for funding research partnerships, and balancing power between low to middle income countries and high-income countries. Lastly, case examples of funding partnerships involving pharmacy are highlighted, emphasizing important lessons learned. This commentary addresses the critical need for providing global health researchers with both important considerations and experience-based recommendations for navigating global funding partnerships using an ethical approach.     

Beyond the question of placebo controls: ethical issues in psychopharmacological drug studies

Rationale There is a broad range of complex ethical issues in the conduct of psychopharmacological drug studies that go beyond the question of the ethics of placebo controls. However, our empirical knowledge with respect to these issues is very limited. This review, although not exhaustive, highlights an array of ethical issues that arose from discussions within the NIMH Human Subjects Research Council Workgroup. Objectives To delineate issues in psychopharmacological drug studies that require debate and would benefit from research leading to the development of empirically-supported guidelines. Methods Information included in this report was drawn from the first author's participation as chair of the NIMH Human Subjects Research Council Workgroup, guidelines for the ethical conduct of research proposed by professional organizations to which the first and third author belong, and relevant research literature. Results We have focused on general issues relating to informed consent, research with special populations, and long-term treatment studies. Additionally, we raise issues relevant to large research-oriented institutions. Conclusions The essential ethical challenge in psychopharmacological trials is to balance risks and benefits in the context of the needs and capacities of individual research subjects. The IRB system must become evidence-based and not rely on unproven assumptions. Specific research studies should be undertaken to address many of the issues of informed consent and research ethics postulated in this paper.