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We performed a systematic survey of original papers published in The Lancet throughout the years 1945, 1946, 1970 and 1995. The Lancet was chosen due to a conservative layout through these years, and the year 1946 added to the analysis to ponder for any war-induced bias. The general layout and structure of the journal were indeed maintained throughout these years. The number of authors per paper increased steadily (from 1.7 +/- 1.3 in 1945 to 6.4 +/- 3.4 in 1995), as well as the number of papers written on behalf of investigation groups (from 1 in 1945 to 37 in 1995). Major changes were observed in the area of origin of the papers, from an overwhelming British Isles' preponderance (87% of papers published in 1945) to a partake with Continental Europe, America and international groups (27, 33, 15 and 12%, respectively of the 1995 papers). The most often addressed fields of medicine shifted from war-, surgery- and microbiology-related subjects in 1945 towards cardiology-, oncology-, and virus-related works in 1995. The most impressive and enduring change was the increase in the use of statistical tools for data analysis and presentation (0.3% of papers in 1945 vs. 60% in 1995).

Background: Aesthetics medicine, a controversial branch of clinical medicine known for its high degree of commercialization, faces numerous conflicts, particularly in some developing countries. The global aesthetics medicine industry requires enhancements of its legal and supervision framework and risk management systems. Aims: This paper aimed to provide a comprehensive visual analysis of academic achievements related to regulatory and legal issues in the field of aesthetic medicine and to identify its development trends and research hotspots. Methods: The Web of Science Core Collection was employed to retrieve relevant studies, resulting in a total of 602 research articles after selection. Utilizing bibliometric methods and CiteSpace, this study analyzed the primary countries, institutions, authors, journals, hotspots, frontiers, and trends in this domain. Results: The findings indicated rapid increases in the number of published papers. The United States emerged as the leading contributor with 131 research papers and the highest intermediate centrality. Eleven keyword clusters were identified, with "adolescence" and "office‐based surgery" being the most recent topics. We also analyzed the trends and frontiers of legal research in medical aesthetics. Conclusion: The importance of informed consent has been increasingly emphasized, and research in the field of medical aesthetics has been gradually expanding beyond individual cosmetic procedures. The management system has become more comprehensive, moreover, guidelines and medical laws have been continually published, with research shifting toward a holistic perspective that encompasses patients, medical aesthetic providers, and regulatory authorities in the study of medical aesthetics regulation and legislation. This paper also proposes some innovative directions for future research and applications. [ABSTRACT FROM AUTHOR]

To obtain data on patient demographics, clinical practices, and long-term outcomes for patients with chronic low back pain treated with implantable drug-delivery systems. The National Outcomes Registry for Low Back Pain collected data at baseline, trialing, implant (or decision not to implant), and at 6- and 12-month follow-ups. Data were collected at all time points, regardless of implant status. Numeric pain ratings and Oswestry Low Back Pain Disability scores from implanted patients were compared among baseline and 6- and 12-month follow-ups. Patients were also asked to rate their quality of life and satisfaction with the therapy. Thirty-six physicians enrolled 166 patients to be trialed for drug-delivery systems. The trialing success rate was 93% (154 patients). In all, 136 patients (82%) were implanted. In the implant group, numeric pain ratings dropped by more than 47% for back pain and more than 31% for leg pain at the 12-month follow-up. More than 65% of implanted patients reduced their Oswestry scores by at least one level at their 12-month follow-ups compared with baseline. At 12-month follow-ups, 80% of implanted patients were satisfied with their therapy and 87% said they would undergo the procedure again. Current clinical practices related to trialing of drug-delivery systems resulted in the majority of patients successfully trialed. At 12-month follow-ups, implanted patients experienced reductions in numeric back and leg pain ratings, improved Oswestry scores, and high satisfaction with the therapy. [ABSTRACT FROM AUTHOR]

Background: It is common practice for emergency physicians to give parenteral opioids for acute pain, however, some treating physicians have concerns that using parenteral opioids can lead to nausea and vomiting when used alone. Therefore, antiemetics are often given prophylactically with opioids for nausea and vomiting in the emergency department (ED). This systematic review evaluates the use of prophylactic antiemetics with parenteral opioids for the treatment of acute pain in the ED.Methods: A 10-year literature search using keywords was performed in PubMed for English-language human studies. Abstracts were screened to identify high-quality studies, which then underwent a more rigorous structured review. The recommendations are made based on the literature review.Results: Eight articles met criteria for structured review and citation in this article. These include one review article, two randomized controlled trials, three prospective observational trials, one retrospective study, and one pre- and post-intervention trial.Conclusions: Based on the literature review, routine use of prophylactic antiemetics are not indicated with administration of parenteral opioids for treatment of acute pain in the ED, as nausea and vomiting are infrequent side effects. The recent literature clearly demonstrates that there are potential undesirable side effects from the use of antiemetics when using opioids. However, one subgroup of patients, those with a known history of nausea and vomiting after opioid use or a history of travel sickness, may benefit from the use of prophylactic antiemetic when being treated with parenteral opioids. [ABSTRACT FROM AUTHOR]

Primary care physicians (PCPs) play an indispensable role in providing comprehensive care and referring patients for specialty care and other medical services. As the COVID-19 outbreak disrupts patient access to care, understanding the quality of primary care is critical at this unprecedented moment to support patients with complex medical needs in the primary care setting and inform policymakers to redesign our primary care system. The traditional way of collecting information from patient surveys is time-consuming and costly, and novel data collection and analysis methods are needed. In this review paper, we describe the existing algorithms and metrics that use the real-world data to qualify and quantify primary care, including the identification of an individual's likely PCP (identification of plurality provider and major provider), assessment of process quality (for example, appropriate-care-model composite measures), and continuity and regularity of care index (including the interval index, variance index and relative variance index), and highlight the strength and limitation of real world data from electronic health records (EHRs) and claims data in determining the quality of PCP care. The EHR audits facilitate assessing the quality of the workflow process and clinical appropriateness of primary care practices. With extensive and diverse records, administrative claims data can provide reliable information as it assesses primary care quality through coded information from different providers or networks. The use of EHRs and administrative claims data may be a cost-effective analytic strategy for evaluating the quality of primary care. [ABSTRACT FROM AUTHOR]

Background: Social determinants of health (SDOH) are the non-medical factors that impact health. Although geographical measures of deprivation are used, individual measures of social risk could identify those most at risk and generate more personalised care and targeted referrals to community resources. We know SDOH are important to health care, but it is not yet known whether their collection via the electronic health record (EHR) is acceptable and useful from the patient perspective. Aim: To synthesise relevant literature to explore patient perspectives on integrating information about SDOH into primary care EHRs, and the opportunities and challenges of its implementation in a general practice setting. Design & setting: Systematic review of primary care-based qualitative and mixed-method studies using thematic framework analysis. Method: Key databases were searched for articles reporting patient perspectives of SDOH collection within the primary care EHR. Qualitative and mixed-methods studies written in English were included. A framework analysis was conducted to identify themes. Results: From 14 included studies, the following five main themes were identified: rationale for SDOH screening and the anticipated outcomes; impact of the provider-patient relationship on patient perceptions; data, which included privacy concerns; screening process and referral; and recommendations for future research. Conclusion: Integration of information on SDOH into the EHR appears acceptable to patients. This review has added to the discussion of whether and how to implement SDOH screening and referral programmes into UK primary care systems. [ABSTRACT FROM AUTHOR]

Transgender patients are at elevated risk of intimate partner violence (IPV), but national guidelines do not recommend routine screening for this population. This paper explores the feasibility and effectiveness of routine IPV screening of transgender patients in a primary care setting by describing an existing screening program and identifying factors associated with referral and engagement in IPV-related care for transgender patients. An IPV "referral cascade" was created for 1,947 transgender primary care patients at an urban community health center who were screened for IPV between January 1, 2014 to May 31, 2016: (a) Of those screening positive, how many were referred? (b) Of those referred, how many engaged in IPV-specific care within 3 months? Logistic regression identified demographic correlates of referral and engagement. Of the 1,947 transgender patients screened for IPV, 227 screened positive. 110/227 (48.5%) were referred to either internal or external IPV-related services. Of those referred to on-site services, 65/103 (63.1%) had an IPV-related appointment within 3 months of a positive screen. IPV referral was associated with being assigned male at birth (AMAB) versus assigned female at birth (AFAB) (AOR = 2.69, 95% CI 1.52, 4.75) and with nonbinary, rather than binary, gender identity (AOR = 2.07, 95%CI 1.09, 3.73). Engagement in IPV-related services was not associated with any measured demographic characteristics. Similar to published rates for cisgender women, half of transgender patients with positive IPV screens received referrals and two-thirds of those referred engaged in IPV-specific care. These findings support routine IPV screening and referral for transgender patients in primary care settings. Provider training should focus on how to ensure referrals are made for all transgender patients who screen positive for IPV, regardless of gender identity, to ensure the benefits of screening accrue equally for all patients. [ABSTRACT FROM AUTHOR]

• Digital Mental Health Services (DMHS) can greatly increase access to care. • Training is needed so providers can effectively integrate DMHS into their treatments. • More research on DMHS is needed, along with regulatory standards. • DMHS may help reduce health disparities but questions remain about cultural tailoring. The papers in this special series make a compelling case for the value of digital mental health services (DMHS; including technology-based interventions, assessments, and prevention programs) to help address some of the currently unmet needs in mental health care. At the same time, the papers highlight the work that needs to be accomplished for DMHS to fulfill their promise. We review the papers' contributions in terms of (a) the imperative to increase access to evidence-informed, high-quality care, especially for underserved populations, both in the United States and globally; (b) ways to use DMHS to improve the ways that clinical care is provided to make treatment provision more effective and efficient; and (c) the current state of the research on DMHS for emotional disorders. We then consider lessons learned and recommendations to move the field forward, such as increasing (and making transparent) the research base on DMHS, adopting regulatory standards for DMHS, attending carefully to training issues for DMHS and best practices for dissemination and implementation, designing specifically for digital platforms, and being intentional about efforts to reduce disparities regarding who benefits from DMHS. [ABSTRACT FROM AUTHOR]

To find the trend and hot points of deafness gene research in the nearly 10 years, a bibliometric analysis of literature in the fields from Web of Science was performed. Python 3.7, Gephi 0.9.2, and SPSS 22.0 were used for cleaning, restructuring, and analysis. A total of 2828 article documents were collected, which were from 651 Science Citation Index Expanded journals, 93 countries/regions, 18 199 authors, and 3148 organizations. PLoS One published more papers than other journals. Among the journals that published more than 30 papers, 10 journals were included in the genetics & heredity class. The top country/region with highest number of papers was United States. However, the top author and top affiliation was Dai Pu (China) and People's Liberate Army General Hospital (China), respectively. The results of co-occurrence network, hierarchical clustering, and multidimensional scale analysis of keywords showed that 2 groups were classified. The 2 groups focused on the gene mutation of deafness and the research objects, methods, factors, and gene locus, respectively. Multidimensional scale analysis told the research character and some research details. The gene mutation and variant of family and population diseases were the hot points. [ABSTRACT FROM AUTHOR]

This special issue of Social Studies of Science centers on the topic of regulation in medicine and, in particular, on the notion of regulatory objectivity, defined as a new form of objectivity in biomedicine that generates conventions and norms through concerted programs of action based on the use of a variety of systems for the collective production of evidence. The papers in the special issue suggest ways in which the notion of regulatory objectivity can be tested, extended, revised, or superseded by more appropriate notions. They insist on the need to examine more closely clinical-therapeutic (and not just clinical-research) activities, and to pay more attention to the activities of regulatory agencies such as the US Food and Drug Administration and to standard-setting organizations. They call attention to the professional and organizational activities surrounding the mobilization of conventions for regulating clinical practices. Finally, they provide material that can help us to think about how analytical notions such as regulatory objectivity may or may not inform interventionist research projects. [ABSTRACT FROM AUTHOR]

This paper examines the effects of conversions between For-Profit and Not-For-Profit forms on quality of medical care in California hospitals. The sample includes elderly patients treated in California's private hospitals from 1990 to 1998 for Acute Myocardial Infarction and Congestive Heart Failure. The results suggest that converted hospitals have experienced quality changes before conversion and that ignoring these changes may bias the estimates of conversion effects. Both conversions are found to have some adverse consequences: Hospitals that converted to FP form show an increase in AMI mortality rates, while those converted to NFP status indicate an increase in CHF mortality outcomes. [ABSTRACT FROM AUTHOR]

Objective: Lung cancer is the most common type of cancer around the world, and it represents the main cause of death in the USA. Surgical treatment is the optimal therapeutic strategy for resectable non-small cell lung cancer. The principal factor for long-term survival after complete resection is the anatomic extension of the neoplasm. However, other factors also have adverse effects on operative mortality, and influence long-term outcome. In this paper we propose an algorithmic solution for the estimation of 5-years survival rate in lung cancer patients undertaking pulmonary resection. Materials and methods: We address the issue of survival analysis through decision-making techniques based on fuzzy and soft set theories. We develop an expert system based on clinical and functional data of lung cancer resections in patients with cancer that can be used to predict the survival of patients. Results: The evaluation of surgical risk in patients undertaking pulmonary resection is a primary target for thoracic surgeons. Lung cancer survival is influenced by many factors. The computational performance of our algorithm is critically analyzed by an experimental study. The correct survival classification is achieved with an accuracy of 79.0%. Our novel soft-set based criterion is an effective and precise diagnosis application for the determination of the survival rate. [ABSTRACT FROM AUTHOR]

Background: Clinical judgment is declining in new graduate nurses, which affects patient safety and is therefore tested on the Next Generation NCLEX. There is limited research describing barriers and facilitators impacting nursing faculty's experiences teaching clinical judgment. Aims: The purpose of this study was to explore barriers and facilitators affecting undergraduate nursing faculty's clinical judgment teaching methods. Methods: Sixteen qualitative interviews were conducted with full-time nursing faculty at seven universities in the Northeast and Southeast regions of the United States. Results: The findings revealed program, student, and faculty factors affecting clinical judgment teaching methods. Subthemes included time, class size, students' class preparation, critical thinking, task orientation, professional development, and faculty resistance. Conclusion: Minimizing barriers and strengthening facilitators based on participants' practices and previous research can support more effective clinical judgment pedagogy, which has the potential to achieve Next Generation NCLEX success and potentially increase patient safety. [ABSTRACT FROM AUTHOR]

This paper reviews the history of psychodynamic treatment of psychosis in the United States, emphasizing the current severe problems in this area, and exploring their causes. It recommends that we bring back the older interpersonal, humanistic approaches, recognizing that reliance on salience-muting medications is both short-sighted and dangerous. [ABSTRACT FROM AUTHOR]

In their critical path initiative, the FDA underlines the urgent need for a standardized approach to capture, receive and analyse clinical study data. Providing the data definition document in a machine readable format such as XML increases the level of automation and improves the efficiency of the regulatory review process. Case report tabulation data definition specification (CRT DDS) is the CDISC standard for providing metadata in XML format for an electronic submission to regulatory authorities such as the FDA. This paper will describe how Kendle has implemented CRT DDS (commonly known as define.xml) Standards Version 1.0.0 at Kendle. Furthermore, it demonstrates how Kendle uses the SAS® based tool Definedoc™ from Meta-Xceed, Ind. (MXI) in the define.xml generation process. Also quality control processes developed by Kendle will be discussed and some interesting features of define.xml and issues encountered with the CDISC standards will be highlighted. This paper will describe the process and challenges of generating define.xml with emphasis on the following: Define.xml generation, discussion of Definedoc™, selected define.xml features, consistency checks and obstacles. [ABSTRACT FROM AUTHOR]

National health insurance coverage estimates for the overall population and specific population subgroups are critical to policymakers and others concerned with access to medical care and the cost and sources of payment for that care. The Medical Expenditure Panel Survey (MEPS) is one of the core health care surveys in the United States that serves as a primary source for these essential national health insurance coverage estimates. The survey is designed to provide annual national estimates of the health care use, medical expenditures, sources of payment and insurance coverage for the U.S. civilian non-institutionalized population. In 2007, the survey experienced two dominant survey design modifications: (1) a new sample design attributable to the sample redesign of the National Health Interview Survey, and (2) an upgrade to the CAPI platform for the survey instrument, moving from a DOS to a Windows based environment. This study examines the impact of these survey design modifications on the national estimates of insurance coverage. The overlapping panel design of the MEPS survey and its longitudinal features are particularly well suited to assess the impact of survey redesign modifications on estimates. Since two independent nationally representative samples are pooled to produce calendar year estimates, one has the capacity to compare estimates based on the “original survey design” in contrast to those derived from the “survey redesign.” This paper examines the correlates of nonresponse incorporated in the estimation techniques and adjustment methods employed in the survey, and the measures utilized for post-stratification overall and by panel. Particular attention is given to assessing the level of convergence in coverage estimates based on the alternative designs as well as the alignment of model based analyses that discern which factors are associated with health insurance classifications. The paper concludes with a discussion of strategies under consideration that may yield additional improvements in the accuracy for these critical policy relevant survey estimates. [ABSTRACT FROM AUTHOR]

Racial-ethnic minorities receive lower quality and intensity of health care compared with whites across a wide range of preventive, diagnostic, and therapeutic services and disease entities. These disparities in health care contribute to continuing racial-ethnic disparities in the burden of illness and death. Several national medical organizations and the Institute of Medicine have issued position papers and recommendations for the elimination of health care disparities. However, physicians in practice are often at a loss for how to translate these principles and recommendations into specific interventions in their own clinical practices. This paper serves as a blueprint for translating principles for the elimination of racial-ethnic disparities in health care into specific actions that are relevant for individual clinical practices. We describe what is known about reducing racial-ethnic disparities in clinical practice and make recommendations for how clinician leaders can apply this evidence to transform their own practices. [ABSTRACT FROM AUTHOR]

The article discusses what the author refers to as the evolution of the ethical standards that are associated with clinical medical care-based human genomic sequencing in America as of 2017, and it mentions policy statements from the American College of Medical Genetics and Genomics. The ethical aspects of genomic medicine are addressed, along with opt-out policies and the risks associated with cancer and cardiovascular disease.

Two papers have appeared in the literature recently reporting the use of the Severity of Opiate Dependence Questionnaire (SODQ) with American and British samples of opiate addicts. This paper presents the findings of a third study. The SODQ was completed by a further 126 subjects attending the original New York Clinic and the results largely confirmed our earlier findings: first the four main sections of the SODQ each give a strong first factor and secondly when these are combined a strong overall factor emerges. These results are again at variance with those found in the British sample and possible reasons briefly discussed. [ABSTRACT FROM AUTHOR]

Digital health technologies (DHTs) can transform neurological assessments, improving quality and continuity of care. In the United States, the Food & Drug Administration (FDA) oversees the safety and efficacy of these technologies, employing a detailed regulatory process that classifies devices based on risk and requires rigorous review and post-market surveillance. Following FDA approval, DHTs enter the Current Procedural Terminology, Relative Value Scale Update Committee, and Centers for Medicare & Medicaid Services coding and valuation processes leading to coverage and payment decisions. DHT adoption is challenged by rapid technologic advancements, an inconsistent evidence base, marketing discrepancies, ambiguous coding guidance, and variable health insurance coverage. Regulators, policymakers, and payers will need to develop better methods to evaluate these promising technologies and guide their deployment. This includes striking a balance between patient safety and clinical effectiveness versus promotion of innovation, especially as DHTs increasingly incorporate artificial intelligence. Data validity, cybersecurity, risk management, societal, and ethical responsibilities should be addressed. Regulatory advances can support adoption of these promising tools by ensuring DHTs are safe, effective, accessible, and equitable. [ABSTRACT FROM AUTHOR]

Purpose In recognition of the importance of performance measurement and MCH epidemiology leadership to quality improvement (QI) efforts, a plenary session dedicated to this topic was presented at the 2014 CityMatCH Leadership and MCH Epidemiology Conference. This paper summarizes the session and provides two applications of performance measurement to QI in MCH. Description Performance measures addressing processes of care are ubiquitous in the current health system landscape and the MCH community is increasingly applying QI processes, such as Plan-Do-Study-Act (PDSA) cycles, to improve the effectiveness and efficiency of systems impacting MCH populations. QI is maximally effective when well-defined performance measures are used to monitor change. Assessment MCH epidemiologists provide leadership to QI initiatives by identifying population-based outcomes that would benefit from QI, defining and implementing performance measures, assessing and improving data quality and timeliness, reporting variability in measures throughout PDSA cycles, evaluating QI initiative impact, and translating findings to stakeholders. MCH epidemiologists can also ensure that QI initiatives are aligned with MCH priorities at the local, state and federal levels. Two examples of this work, one highlighting use of a contraceptive service performance measure and another describing QI for peripartum hemorrhage prevention, demonstrate MCH epidemiologists' contributions throughout. Challenges remain in applying QI to complex community and systems-level interventions, including those aimed at improving access to quality care. Conclusion MCH epidemiologists provide leadership to QI initiatives by ensuring they are data-informed and supportive of a common MCH agenda, thereby optimizing the potential to improve MCH outcomes. [ABSTRACT FROM AUTHOR]

The controversy over patients' access to stem cell interventions is familiar to scholars of the drug regulatory system and the politics of evidence-based medicine. What counts as evidence of a biomedical intervention's safety and effectiveness? Who should define and assess safety and effectiveness, and how? In the first section of the paper we describe the types of stem cells that may be therapeutically effective. We then describe how the US Food and Drug Administration asserted regulatory authority over certain stem cell interventions and the legal challenge to the agency's actions. Next, we place the debate about patients' access to stem cell interventions in the broader context of efforts in the US to promote and implement health technology assessment and the debate about standards of evidence. We then review several proposed initiatives to get stem cell and other new biomedical interventions into the clinic faster and consider the extent to which these policies can resolve the underlying conflicts about evidentiary standards for clinical use. Finally, we consider whether efforts to expedite access to biomedical technologies may undermine countervailing efforts to improve the safety and effectiveness of stem cell interventions. [ABSTRACT FROM AUTHOR]

Purpose - The purpose of this paper is to explore the relationship between hospitals' electronic health record (EHR) adoption characteristics and their patient safety cultures. The "Meaningful Use" (MU) program is designed to increase hospitals' adoption of EHR, which will lead to better care quality, reduce medical errors, avoid unnecessary cost, and promote a patient safety culture. To reduce medical errors, hospital leaders have been encouraged to promote safety cultures common to high-reliability organizations. Expecting a positive relationship between EHR adoption and improved patient safety cultures appears sound in theory, but it has yet to be empirically demonstrated. Design/methodology/approach - Providers' perceptions of patient safety culture and counts of patient safety incidents are explored in relationship to hospital EHR adoption patterns. Multi-level modeling is employed to data drawn from the Agency for Healthcare Research and Quality's surveys on patient safety culture (level 1) and the American Hospital Association's survey and healthcare information technology supplement (level 2). Findings - The findings suggest that the early adoption of EHR capabilities hold a negative association to the number of patient safety events reported. However, this relationship was not present in providers' perceptions of overall patient safety cultures. These mixed results suggest that the understanding of the EHR-patient safety culture relationship needs further research. Originality/value - Relating EHR MU and providers' care quality attitudes is an important leading indicator for improved patient safety cultures. For healthcare facility managers and providers, the ability to effectively quantify the impact of new technologies on efforts to change organizational cultures is important for pinpointing clinical areas for process improvements. [ABSTRACT FROM AUTHOR]

Background: The scale and scope of medical tourism have expanded rapidly over the last few decades. Turkey is becoming an important player in this market because of its relatively better service quality and large comparative cost advantage.Methods: This paper compares cost, quality and effectiveness of in-vitro fertilization (IVF) in the USA and in Turkey. The data from Turkey were obtained from a hospital specializing in IVF services and the US data came from secondary sources. Package price offered by the dominant IVF-service provider to international patients in Turkey was used as a measure of cost for Turkey while IVF-specific service prices were used to estimate the cost for USA. To compare quality and effectiveness of IVF services, a number of general clinical quality indicators and IVF success rate were used.Results: Indicators of quality, cost and success rate in the Turkish hospital were found to be better than the corresponding indicators in US hospitals. The cost difference of IVF services between USA and Turkey is so significant that the overall cost of obtaining the service from Turkey remains lower even with additional expenses for travel and accommodation.Conclusions: Cost-effectiveness ratio of IVF treatment per successful clinical pregnancy was much lower in Turkey than in the USA. It appears that cost and quality are the two most important factors affecting demand for health care services by international patients in Turkey. Like other important players in the medical tourism market, Turkey should be able to take advantage of its success in IVF, a highly specialized niche market, to transform its health system into an important exporter of general health services. [ABSTRACT FROM AUTHOR]

Background: Public health surveillance has traditionally relied on manual processes including paper-based reporting by clinicians. The introduction of electronic laboratory reporting increased the efficiency and completeness of infectious disease surveillance but clinical and risk factor data are often still collected manually. The use of electronic health records (EHR) has significant promise to enrich surveillance by collecting these data automatically and by expanding surveillance to chronic diseases (e.g., diabetes, hypertension, obesity). However, the extent of the use of EHRs for public surveillance is not well studied. Evidence Acquisition: The peer-reviewed medical literature was searched for descriptions of the use of EHRs for public health surveillance. Evidence Synthesis: This literature is very limited. The largest body of work describes the experience of the Electronic Medical Record Support for Public Health system (ESPnet) currently being used in Massachusetts, Ohio, and Texas. It shows both the potential and challenges of using EHRs for surveillance. Discussion: Routine incorporation of EHR data into surveillance provides a unique opportunity to expand the breadth, quality, and efficiency of surveillance efforts. However, more research is needed to document the potential benefits and limitations of EHRs. Implications: Surveillance practitioners should work with health systems and EHR vendors to explore the use of EHRs. Policymakers should increase financial support for EHR-based surveillance by building requirements into Meaningful Use and other initiatives. In addition, clinical medicine and public health should work together to develop meaningful surveillance measures that can simultaneously improve the care of individuals and populations. [ABSTRACT FROM AUTHOR]

This paper provides an overview of the rapidly evolving paradigm of "Integrative Mental Health (IMH)." The paradigm of contemporary biomedical psychiatry and its contrast to non-allopathic systems of medicine is initially reviewed, followed by an exploration of the emerging paradigm of IMH, which aims to reconcile the bio-psycho-socio-spiritual model with evidence-based methods from traditional healing practices. IMH is rapidly transforming conventional understandings of mental illness and has significant positive implications for the day-to-day practice of mental health care. IMH incorporates mainstream interventions such as pharmacologic treatments, psychotherapy, and psychosocial interventions, as well as alternative therapies such as acupuncture, herbal and nutritional medicine, dietary modification, meditation, etc. Two recent international conferences in Europe and the United States show that interest in integrative mental health care is growing rapidly. In response, the International Network of Integrative Mental Health (INIMH: www.INIMH.org) was established in 2010 with the objective of creating an international network of clinicians, researchers, and public health advocates to advance a global agenda for research, education, and clinical practice of evidence-based integrative mental health care. The paper concludes with a discussion of emerging opportunities for research in IMH, and an exploration of potential clinical applications of integrative mental health care., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background: Medical educators seek innovative ways to engage learners efficiently and effectively. Gamification has been explored as one way to accomplish this feat; however, questions remain about which contexts gamification would be most useful. Time constraints and student interest present major barriers for teaching laboratory medicine to students. This study aims to compare two versions of an interactive online module, one gamified and one not, for teaching laboratory medicine concepts to pre-clinical medical students. Methods: First-year medical students reviewed either a gamified or non-gamified version of an interactive online module in preparation for an in-person flipped classroom session on Laboratory Medicine. Learning theory guided the design of the modules and both contained identical content, objectives, and structure. The "gamified" module included the additional elements of personalization, progress meters, points, badges, and story/role play. After reviewing the module, students completed an anonymous knowledge check and optional survey. Results: One hundred seventy-one students completed the post module knowledge check as assigned (82 gamified, 89 non-gamified). Knowledge check scores were higher for the students who reviewed the gamified module (p < 0.02), corresponding to an effect size of 0.4 for the gamified module. Eighty-one students completed optional post-module surveys (46 gamified, 35 non-gamified). Instructional efficiency was calculated using task difficulty questions and knowledge check scores, and the resulting instructional efficiency was higher for the gamified module. There was no significant difference in the student-reported time required to complete the modules. Additionally, both versions of the module were well received and led to positive ratings related to motivation and confidence. Finally, examination of open-ended survey results suggested that the addition of game elements added value to the gamified module and enhanced engagement and enjoyment. Conclusions: In this setting, the addition of gamification to an interactive online module enhanced learning outcome, instructional efficiency, student engagement and enjoyment. These results should inspire further exploration of gamification for teaching Laboratory Medicine concepts to pre-clinical medical students. [ABSTRACT FROM AUTHOR]

This article describes the development of a video serial drama intervention that was designed to address factors that influence HIV in the United States among Black youth. These include HIV testing, sexual behaviors not protected by condoms, negative attitudes towards sexual minorities, and HIV stigma. Behavior-change principles (social learning theory and education-entertainment) and input from members of the priority audience formed the basis of this 27-episode (3 minutes each) drama for dissemination on multiple platforms, including in public spaces or privately online. The developmental process, specifically involving members of the population of interest and use of behavioral theory, enriched the narrative elements and likely ensured intervention acceptability, enhancing effectiveness. Public health practitioners and prevention programmers may want to consider using this intervention and/or the narrative communication approach when intervening to change behavior. [ABSTRACT FROM AUTHOR]

Clinical and translational research increasingly requires computation. Projects may involve multiple computationally oriented groups including information technology (IT) professionals, computer scientists, and biomedical informaticians. However, many biomedical researchers are not aware of the distinctions among these complementary groups, leading to confusion, delays, and suboptimal results. Although written from the perspective of Clinical and Translational Science Award (CTSA) programs within academic medical centers, this article addresses issues that extend beyond clinical and translational research. The authors describe the complementary but distinct roles of operational IT, research IT, computer science, and biomedical informatics using a clinical data warehouse as a running example. In general, IT professionals focus on technology. The authors distinguish between two types of IT groups within academic medical centers: central or administrative IT (supporting the administrative computing needs of large organizations) and research IT (supporting the computing needs of researchers). Computer scientists focus on general issues of computation such as designing faster computers or more efficient algorithms, rather than specific applications. In contrast, informaticians are concerned with data, information, and knowledge. Biomedical informaticians draw on a variety of tools, including but not limited to computers, to solve information problems in health care and biomedicine. The paper concludes with recommendations regarding administrative structures that can help to maximize the benefit of computation to biomedical research within academic health centers.

Background: The widespread availability of new computational methods and tools for data analysis and predictive modeling requires medical informatics researchers and practitioners to systematically select the most appropriate strategy to cope with clinical prediction problems. In particular, the collection of methods known as 'data mining' offers methodological and technical solutions to deal with the analysis of medical data and construction of prediction models. A large variety of these methods requires general and simple guidelines that may help practitioners in the appropriate selection of data mining tools, construction and validation of predictive models, along with the dissemination of predictive models within clinical environments., Purpose: The goal of this review is to discuss the extent and role of the research area of predictive data mining and to propose a framework to cope with the problems of constructing, assessing and exploiting data mining models in clinical medicine., Methods: We review the recent relevant work published in the area of predictive data mining in clinical medicine, highlighting critical issues and summarizing the approaches in a set of learned lessons., Results: The paper provides a comprehensive review of the state of the art of predictive data mining in clinical medicine and gives guidelines to carry out data mining studies in this field., Conclusions: Predictive data mining is becoming an essential instrument for researchers and clinical practitioners in medicine. Understanding the main issues underlying these methods and the application of agreed and standardized procedures is mandatory for their deployment and the dissemination of results. Thanks to the integration of molecular and clinical data taking place within genomic medicine, the area has recently not only gained a fresh impulse but also a new set of complex problems it needs to address.

This paper charts a course for assessing the impact of healing relationships in clinical medicine. The system of healing relationships is multidimensional, longitudinal, contextual, and emergent. In a new conceptual model, healing relationships are identified in terms of the conditions of healing intention, motivation, and information transfer, and in terms of the attributes of emotional engagement, mindfulness, and trust. Five components of quality in healing relationships--adaptability, cohesion, growth, caring-in-relation, and commitment--are noted, and the importance of timing, attunement, and cultural meaning systems are described. Communication, clinical method, caring, competence, and treatment characteristics are differentiated as mediating processes; expectancy and conditioning are positioned as antecedents of healing relationships. Multiple personal and contextual outcomes are addressed with a recommendation for assessing a minimal set of each, including symptom resolution, health status, sense of coherence, patient enablement, cost effectiveness, quality of care, efficiency, access, and healer satisfaction. A wheel of knowledge connects 3 ways of knowing--personal, connected, and objective--with appropriate methodology and research designs. Applying this wheel to the issue of assessing impact in healing relationships reveals the need for multiple methods, perspectives, and triangulations. A critical multiplist strategy is one means for advancing this area of research. A double-helix trial design is introduced, in which one strand consists of a standard quantitative approach and the other consists of qualitative methods. The 2 strands are bonded by the questions addressed and by the participants in the study.

The ongoing water crises in Detroit and Flint, Michigan, offer dramatic cases of retrogression in realizing the human right to water--particularly striking in a region that enjoys access to one-fifth of the world's freshwater and a country that has historically enjoyed near-universal access to water and sanitation. Efforts to secure safe, sufficient, affordable, acceptable, and accessible water in these cities reveal a troubling inability to protect the human right to water through legal measures. Compounding the challenge is the lack of reliable government data on the scope and impacts of the water crises--a void that residents have organized to fill. Activists have engaged a number of citizen-led research projects to demonstrate the health impacts of unsafe and unaffordable water. This paper discusses the process and potential of such projects to advance the substance of the human right to water in the United States, considering their effects within and outside the law. These research efforts have significant methodological and legal constraints with respect to widespread water insecurity, exposing a serious vulnerability in communities' ability to protect drinking water and public health in the United States through legal means. However, drawing on Amartya Sen's theory of human rights, I elaborate the extra-juridical powers of human rights, emphasizing their power to galvanize action and articulate ethical demands. Citizen science is a powerful mode of engaging residents in the articulation--and quantification--of those human rights demands, as I demonstrate with local cases. [ABSTRACT FROM AUTHOR]

Abstract: The use of medications to treat substance use disorders (SUDs) has emerged as a potentially central part of the treatment armamentarium. In this paper we present data from several recent US national surveys showing that despite the clinical promise of these medications, there has been limited adoption of pharmacotherapies in the treatment of SUDs. The data reveal variable patterns of use of disulfiram, buprenorphine, tablet naltrexone, acamprosate and injectable naltrexone. After examining the environmental and institutional context for the adoption of pharmacotherapies, the specific organizational facilitators and barriers of medication adoption are considered. The paper concludes with a discussion of the minimal clinical and administrative guidance available to enhance adoption, the lack of client and consumer knowledge of medications that puts a brake on their adoption and availability, and the difficulties that must be surmounted in bringing new medications to market. [Copyright &y& Elsevier]

The article discusses the highlights of an International Association of Gerontology and Geriatrics (IAGG) workshop on nursing homes. One of the paper presented in the workshop focused on the state of nursing homes within long-term care in Catalonia, Spain. The event also addressed the challenges posed by the increasing elderly population in China, as well as the occupancy rate in Chinese nursing homes. Another topic addressed in the workshop was chronic pain in long-term care facilities.

Electronic health records (EHRs) have emerged as a major topic in health care and are central to the federal government's strategy for transforming healthcare delivery in the United States. Recent federal actions that aim to promote the use of EHRs promise to have significant implications for laboratories and for pathology practices. Under the HITECH (Health Information Technology Economic and Clinical Health) Act, an EHR incentive program has been established through which individual physicians and hospitals can qualify to receive incentive payments if they achieve "meaningful use" of "certified" EHR technology. The rule also establishes payment penalties in future years for eligible providers who have not met the requirements for meaningful use of EHRs. Meaningful use must be achieved using EHR technology that has been certified in accordance with functional and technical criteria that are set forth a regulation that parallels the meaningful use criteria in the incentive program. These actions and regulations are important to laboratories and pathologists for a number of reasons. Several of the criteria and requirements in the meaningful use rules and EHR certification criteria relate directly or indirectly to laboratory testing and laboratory information management, and future stage requirements are expected to impact the laboratory as well. Furthermore, as EHR uptake expands, there will be greater expectations for electronic interchange of laboratory information and laboratory information system (LIS)-EHR interfaces. Laboratories will need to be aware of the technical, operational, and business challenges that they may face as expectations for LIS-EHR increase. This paper reviews the important recent federal efforts aimed at accelerating EHR use, including the incentive program for EHR meaningful use, provider eligibility, and EHR certification criteria, from a perspective of their relevance for laboratories and pathology practices. [ABSTRACT FROM AUTHOR]

The purpose of this paper is to describe the creation, evolution, and implementation of a database of nursing-sensitive and potentially nursing-sensitive indicators, the Military Nursing Outcomes Database (MilNOD). It discusses data quality, utility, and lessons learned. Prospective data collected each shift include direct staff hours by levels (i.e., registered nurse, other licensed and unlicensed providers), staff categories (i.e., military, civilian, contract, and reservist), patient census, acuity, and admissions, discharges, and transfers. Retrospective adverse event data (falls, medication errors, and needle-stick injuries) were collected from existing records. Annual patient satisfaction, nurse work environment, and pressure ulcer and restraint prevalence surveys were conducted. The MilNOD contains shift level data from 56 units in 13 military hospitals and is used to target areas for managerial and clinical performance improvement. This methodology can be modified for use in other healthcare systems. As standard tools for evidence-based management, databases such as MilNOD allow nurse leaders to track the status of nursing and adverse events in their facilities. [ABSTRACT FROM AUTHOR]

Background: Accurate prognosis is vital to the initiation of advance care planning particularly in a vulnerable, at risk population such as care home residents. The aim of this paper is to report on the revision and simplification of the MDS Mortality Rating Index (MMRI) for use in clinical practice to predict the probability of death in six months for care home residents. Methods: The design was a secondary analysis of a US Minimum Data Set (MDS) for long term care residents using regression analysis to identify predictors of mortality within six months. Results: Using twelve easy to collect items, the probability of mortality within six months was accurately predicted within the MDS database. The items are: admission to the care home within three months; lost weight unintentionally in past three months; renal failure; chronic heart failure; poor appetite; male; dehydrated; short of breath; active cancer diagnosis; age; deteriorated cognitive skills in past three months; activities of daily living score. Conclusion: A lack of recognition of the proximity of death is often blamed for inappropriate admission to hospital at the end of an older person's life. An accurate prognosis for older adults living in a residential or nursing home can facilitate end of life decision making and planning for preferred place of care at the end of life. The original MMRI was derived and validated from a large database of long term care residents in the USA. However, this simplification of the revised index (MMRI-R) may provide a means for facilitating prognostication and end of life discussions for application outside the USA where the MDS is not in use. Prospective testing is needed to further test the accuracy of the MMRI-R and its application in the UK and other non-MDS settings. [ABSTRACT FROM AUTHOR]

Objective: The aim of this paper was to review the large US National Institute of Mental Health-sponsored depression intervention effectiveness study, STAR*D, in order to evaluate critically its relevance for Australasian clinicians. Conclusions: STAR*D is a landmark study which tried to address issues of effectiveness rather than efficacy, of a number of interventions for depression. However, methodological shortcomings limit the utility of the study in informing Australasian clinical practice. [ABSTRACT FROM AUTHOR]

Data Safety and Monitoring Boards (DSMBs) have been referred to as a “growth industry,” and this trend continues to be fueled by recent FDA guidance and the NIH's requirement that DSMBs be employed in virtually all phase III clinical trials. The widening role of DSMBs has been sporadically questioned on ethical grounds, but growth has continued, despite the fact that many of the questions endure, unanswered, save for repeated references to safeguarding the scientific integrity of trials. This may be about to change. The recently appointed director of the Office for Human Research Protections (OHRP), Jerry Menikoff, is on record as regarding current practices — where consent forms often promise what the DSMB has been assembled to specifically not provide — as constituting fraudulent behavior. That is, a subject may inherently rely on, to their detriment, information that has been misrepresented in the consent document. In this paper, we assemble some of the enduring questions and top them off with Menikoff's tour de force to present what we hope will be a compelling argument to require that consent forms fairly represent what the DSMB will do — and not do — with trial data as they accumulate. We argue that DSMBs should be used only in rare circumstances, and question the practice of precluding principal investigators from DSMB membership, but our main thrust is to ensure that DSMBs, when used at all, are properly described in trial consent forms. [ABSTRACT FROM AUTHOR]

The purpose of this paper is to summarize the best evidence regarding the impact of providing patient-reported outcomes (PRO) information to health care professionals in daily clinical practice. Systematic review of randomized clinical trials (Medline, Cochrane Library; reference lists of previous systematic reviews; and requests to authors and experts in the field). Out of 1,861 identified references published between 1978 and 2007, 34 articles corresponding to 28 original studies proved eligible. Most trials (19) were conducted in primary care settings performed in the USA (21) and assessed adult patients (25). Information provided to professionals included generic health status (10), mental health (14), and other (6). Most studies suffered from methodologic limitations, including analysis that did not correspond with the unit of allocation. In most trials, the impact of PRO was limited. Fifteen of 23 studies (65%) measuring process of care observed at least one significant result favoring the intervention, as did eight of 17 (47%) that measured outcomes of care. Methodological concerns limit the strength of inference regarding the impact of providing PRO information to clinicians. Results suggest great heterogeneity of impact; contexts and interventions that will yield important benefits remain to be clearly defined. [ABSTRACT FROM AUTHOR]

Lung cancer is the leading cause of cancer mortality in men and women. Lung cancer accounts for approximately 30% of all cancer deaths in the United States. In addition, it is the most often diagnosed cancer in men, and the second most often diagnosed cancer in women. Five-year survival rates in lung cancer remain very low, around 15%. Approximately 45% of patients present with stage III disease. The majority of these patients are considered non-resectable, leading to the poor survival statistics seen in this disease. Unfortunately, survival rates have not improved in the past 30 years despite much research in diagnostics and therapeutics. Patients with advanced disease often experience multiple symptoms, including fatigue, pain, dyspnea, cough, hemoptysis, and anorexia. This paper will review the enormous toll that lung cancer takes on society, as well as individuals and families affected. In addition, we will examine psychosocial factors pertinent to lung cancer. Specifically, the article briefly discusses treatment approaches to lung cancer, as they relate to quality of life (QOL). QOL as a construct within lung cancer is then reviewed. Comment is made on the evaluation and prognostic importance of QOL. Next, economic and survivorship aspects of lung cancer are discussed. Finally, a summary of relevant psychosocial interventions for patients diagnosed with lung cancer is given. [ABSTRACT FROM AUTHOR]

The recent focus on health care quality improvement and cost containment has led some policymakers and practitioners to advocate the adoption of health information technology. One such technology is the Electronic Medical Record (EMR), which is predicted to change and improve health care in the USA. Little is known about factors that influence hospital adoption of this relatively new technology. The purpose of this paper is to determine the national prevalence of EMR adoption in acute care hospitals while examining the organizational and environmental correlates using a Resource Dependence Theoretical Perspective. Significant predictors of hospital EMR use may indicate barriers to use for some hospitals and can be used to guide policy. This study uses a non-experimental cross sectional design to examine hospital EMR use in 2004. A logistic regression approach is used to determine the correlations between hospital EMR use and organizational and environmental characteristics. Hospital EMR use was identified using the HIMSS Analytics data. Organizational and environmental variables were measured using data from the AHA, CMS (financial and case mix) and ARF. Hospital EMR adoption is significantly associated with environmental uncertainty, type of system affiliation, size, and urban-ness. The effects of competition, munificence, ownership, teaching status, public payer mix, and operating margin were not statistically significant. Significant predictors of hospital EMR adoption represent barriers that may prevent certain hospitals from obtaining and using EMRs. These hospitals include those that are smaller, more rural, non-system affiliated, and in areas of low environmental uncertainty. Since EMR adoption may be an organizational survival strategy for hospitals to improve quality and efficiency, hospitals that are at risk of missing the wave of implementation should be offered services and incentives to enable them to implement and maintain EMR systems. [ABSTRACT FROM AUTHOR]

In the United States, tobacco treatment specialists are professionals from a variety of backgrounds trained to deliver moderate to intensive evidence-based tobacco treatment in a variety of settings across the country. This paper reports the results of a study that examined the extent to which specialists participating in a larger study adhered to clinical practice guidelines for tobacco dependence using standardized patient assessments. A total of 64 tobacco treatment specialists completed a survey and two audiotaped standardized patient interviews. Overall, 41% and 31% of tobacco treatment specialists demonstrated 80% or more of session content and interviewing skills assessed, respectively, when required to demonstrate the skill in both standardized patient interactions. These rates increased to 85% and 56%, respectively, when using the less stringent criteria of demonstrating the skill in at least one of the two standardized patient interactions. Tobacco treatment specialists who had attended a greater number of types of tobacco treatment training exhibited both greater coverage of session content (p<.06) and greater interviewing skills (p<.02). Those who had achieved certification as a tobacco treatment specialist exhibited greater coverage of session content (p<.02), and those perceiving more positive support from their agency for their services exhibited greater interviewing skills (p=.02). Although the tobacco treatment specialists evaluated appear to have the necessary skills to deliver guideline-based intervention, they demonstrated only moderate adherence to the guidelines when expected to do so consistently across multiple assessments. Findings suggest specific components of tobacco treatment and interviewing skills that would benefit from strengthening through training and support. [ABSTRACT FROM AUTHOR]

In 1993, the National Institutes of Health (NIH) passed The Revitalization Act (Subtitle B) which mandated that all NIH funded clinical trials have “appropriate representation” of minority and women subjects. Our aim was to evaluate the impact of the mandate by examining the reporting and inclusion of minority and female subjects into NIH K-Award funded clinical trials, addressing the minority predominant diagnoses of diabetes and clinical obesity. Using the CRISP search engine and PUBMED, we selected publications published by the National Institute on Aging (NIA) and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) K-grant recipients during 1989–2004, associated with all the diabetes and obesity clinical trials. Studies were stratified into three timeline categories (1989–1993, pre-mandate; 1993–1996, post-mandate, and 1997–present, well past mandate) to evaluate trends in the recruiting of minorities and women before, during, and after the passing of the Revitalization Act. Of the 165 papers, only 37% disclosed race, a number that did not improve over time (p = .15), whereas 92% disclosed gender. Clinical trials that focused on females increased across the 3 timeframes (p < .001) for diabetes studies but not obesity studies. Overall, disclosure of race declined over the 3 timeframes whereas individually, the disclosure of African Americans improved. [ABSTRACT FROM AUTHOR]

Aims: Numerous studies document the effectiveness of intensive clinical interventions to treat tobacco dependence in adult smokers. Empirical studies have provided limited support for the efficacy of such interventions among adolescent smokers, yet participation, retention, and quit rates associated with these interventions tend to be relatively low. Brief clinical interventions may be a promising alternative for promoting smoking cessation in adolescents. The purpose of this paper is to examine the efficacy and use of brief clinical interventions for adolescent smokers, healthcare providers’ provision of such treatment, barriers to adoption, and policies to increase brief clinical intervention provision. Methods: Studies were collected from the Centers for Disease Control and Prevention's Office of Smoking and Health, Medline, Psychinfo, PubMed, and the Cochrane Library. We also examined references identified from pertinent articles and books and elicited suggestions from experts in the field of tobacco control. Investigations were primarily confined to those conducted in the USA to allow ease of comparisons among studies. In addition, we chose to concentrate on research conducted in the USA because differences between the USA healthcare system and that of other countries would result in different barriers to adoption and policy recommendations. Findings: Results showed that, although healthcare professionals appear to be screening adolescents for their smoking status, rates of counseling and follow-up are disappointingly low. Obstacles to brief clinical intervention adoption include clinicians’ lack of knowledge and confidence regarding brief intervention delivery, lack of understanding regarding the unique use patterns of adolescent smokers, and focus on prevention instead of treatment. Clinician training can increase the confidence with which healthcare providers interact with their adolescent patients. Organizational changes include chart reminders, reimbursement for counseling, and staff behavior monitoring. Conclusions: Additional studies on efficacious methods to help adolescent smokers quit smoking are critically needed. Research on ways in which to increase brief clinical intervention provision are also warranted to prevent teenage smokers from carrying this habit, along with its associated morbidity and mortality risks, into adulthood. [ABSTRACT FROM AUTHOR]

In the 1950s, Emanuel Friedman described the first comprehensive method of evaluating labour in clinical practice. In this landmark work, Friedman described the relationship between the duration of labour and cervical dilation as a sigmoid curve and outlined a tool for following labour progression and for identifying abnormal labour. His definitions of labour protraction and arrest continue to be applied in contemporary obstetric practice, although there have been considerable changes since in the clinical management of labour and delivery. This paper provides an overview of Friedman's work, addresses various methodological challenges in studying labour progression, and describes the utility of more advanced statistical methods for studying labour progression, such as survival analysis, compared with other approaches. Additional research that utilises and refines such methods will provide greater insight into labour progression and may assist in updating the diagnostic criteria for labour protraction and arrest disorders in contemporary obstetric practice. Moreover, such detailed information could have important clinical implications towards reducing the rate of primary caesarean delivery in the United States. [ABSTRACT FROM AUTHOR]

Objective: To examine the generalizability of two National Institutes of Health (NIH)-funded double-blind randomized placebo-controlled clinical trials in patients with chronic Lyme disease and to determine whether selection factors resulted in the unfavorable outcomes. Design: Epidemiologic review of the generalizability of two trials conducted by Klempner et al. This paper considers whether the study group was representative of the general chronic Lyme disease population. Results: In their article in The New England Journal of Medicine, Klempner et al. failed to discuss the limitations of their clinical trials. This epidemiologic review argues that their results are not generalizable to the overall Lyme disease population. The treatment failure reported by the authors may be the result of enrolling patients who remained ill after an average of 4.7 years and an average of 3 previous courses of treatment. The poor outcome cited in these trials may be explained by having selected patients who had undergone delayed treatment or multiple treatments unsuccessfully. These selection factors were not addressed by the studies' authors, nor have they been discussed by reviewers. The trials have been over-interpreted by the NIH and widely publicized in a press release. The results have been extrapolated to other groups of Lyme disease patients by commentators, by a case discussant in an influential medical journal, and by health insurance companies to deny antibiotic treatment. Conclusion: The Klempner et al. trials are assumed to be internally valid based on a Randomized Control Trial (RCT) design. However, this review argues that the trials have limited generalizability beyond the select group of patients with characteristics like those in the trial. Applying the findings to target populations with characteristics that differ from those included in these trials is inappropriate and may limit options for chronic Lyme disease patients who might benefit from antibiotic treatment. [ABSTRACT FROM AUTHOR]

There is a dearth of studies of oral lesions in children and youths using probability samples of a general population. The present paper describes the results of the Third National Health and Nutrition Examination Survey, 1988–1994 (NHANES III), and compares them to those of the National Survey of Oral Health in US Schoolchildren, 1986–1987.The NHANES III was a large US study based on a multistage probability sample. Dentist examiners were trained to recognize, classify and record, in a standard manner, the clinical characteristics of each of the 48 conditions of interest using procedures based on the World Health Organization'sGuide to Epidemiology and Diagnosis of Oral Mucosal Diseases.Examinations were performed on 10 030 individuals (10·26%) aged between 2 and 17 years, 914 of whom had a total of 976 lesions. The lip was the most frequent site of lesions (30·7%), followed by the dorsum of the tongue (14·7%) and the buccal mucosa (13·6%). Lesions were more prevalent in males (11·76%) than females (8·67%). The most prevalent lesions were lip/cheek bite (1·89%), followed by aphthous stomatitis (1·64%), recurrent herpes labialis (1·42%) and geographic tongue (1·05%). The prevalence of recurrent aphthous stomatitis in the NHANES III child and youth survey was substantially higher than that for adults, while the NHANES III adult estimates for geographic tongue (1·85%; 95% CI 1·42, 2·28) and cheek/lip bite (3·05%; 95% CI 2·36, 3·74) were substantially greater than those for children and youths (0·97% and 2·05%, respectively).Reported prevalences for rare conditions in other studies employing more selected samples (especially if standard errors or confidence intervals are not provided) should be interpreted with caution. Studies of adult populations, however valid, may have limited applicability to children. [ABSTRACT FROM AUTHOR]

Many variations exist in editorial peer review practices in clinical medicine journals. These practices will become more crucial as medical journals make more of their contents available via the World Wide Web. This paper explores five fundamental dimensions of editorial peer review variations: (1) the extent to which manuscripts are subjected to peer review; (2) the sequence of decision points in the peer review process; (3) blinding practices; (4) acceptance rates for submitted manuscripts; and (5) guidelines stating editors' expectations of reviewers. Variations in editorial peer review practices make it difficult to define a "peer reviewed journal" in clinical medicine. Research in this relatively new area of inquiry has not established the relative strengths of each variation in relation to a journal's quality.