Medical Care Research Research Articles

Should The Pharmaceutical Industry Be A Regulated Utility?

This new book by Marcia Angell, former editor of the New England Journal of Medicine, depicts an industry peopled by executives whose greed leads them to do bad things. They waste society’s wealth on marketing instead of research. They devote too much of their research and development (RD academic institutions; public equity markets; and, yes, large, cash-rich drug companies to fund their R&D. It should go without saying that the funders invest when they expect financial returns that exceed what they can get from safer investments. The same economic imperative drives the large brand-name drug companies, but the availability of cash from sales of current products can hide that truth from the casual observer. In the short run, drug companies can squander their profits on poor R&D investB o o k R e v i e w s

Index to Medical Care Research and Review Volume 61

Index to Medical Care Research and Review Volume 61

Barriers to participating in an HIV vaccine trial

Barriers to participating in an HIV vaccine trial

Carolyn M. Clancy on the Agency for Healthcare Research and Quality.

Carolyn M. Clancy, MD, serves as Director of the Agency for Healthcare Research and Quality (AHRQ) in the U.S. Department of Health and Human Services (DHHS). Prior to her appointment as director on February 5, 2003, Dr. Clancy served as AHRQ's acting director (since March 2002) and before that as director of AHRQ's Center for Outcomes and Effectiveness Research (COER). Dr. Clancy is a general internist and health services researcher and a graduate of Boston College and the University of Massachusetts Medical Schools. Following clinical training in internal medicine, Dr. Clancy was a Henry Kaiser Family Foundation Fellow at the University of Pennsylvania. She was also an assistant professor in the Department of Internal Medicine at the Medical College of Virginia in Richmond prior to joining AHRQ in 1990. Her major research interests include women's health, primary care, access to care, and the effect of financial incentives on physicians' decisions. She holds an academic appointment at The George Washington University School of Medicine (Clinical Associate Professor, Department of Medicine) and serves as Senior Associate Editor, Health Services Research. Dr. Clancy is a member of the editorial boards of several journals (American Journal of Public Health; Journal of Evaluation in Clinical Practice; Annals of Family Medicine, and Medical Care Research and Review), has published widely in peer-reviewed journals, and has edited or contributed to seven books.

Physicians working part-time

In order to ensure the best possible medical care and high-quality research, hospital medical staff must be well educated and highly motivated. Part-time work can help to provide good human resources. Moreover, part-time jobs are often necessary as a means of juggling work and family responsibilities. The aim of this study was to illustrate the legal and educational groundwork for part-time work for physicians in Austria and to outline the advantages and drawbacks of part-time work. In March 2003, all medical doctors working part-time at hospitals in the Austrian state of the Tyrol (n = 60) were surveyed by means of a written questionnaire with the aim of finding out their motives for taking a part-time job as well as the positive and negative aspects involved. The response rate was nearly 70% (n = 40). Most of the part-time hospital physicians were female. The vast majority chose part-time employment in order to better balance family and job. Problems involved in part-time work are legal issues (part-time employment does not always qualify for medical training), the comparatively low salary and the fewer career opportunities. All respondents agreed that patient care, teaching and research are not compatible on a part-time basis. Another negative aspect is the generally strong time pressure experienced in part-time jobs. Despite these negative aspects of working part-time, advantages are considered more important, especially the better balancing of job and family and the possibility of an important early professional reintegration. Better acceptance of part-time jobs would help to make part-time work more attractive. An important improvement is associated with the forthcoming changes in the laws governing part-time work and medical training.

Goldberger’s war:The life and work of a public health crusader

In the early twentieth century, over 100,000 poor Southerners, young and old, black and white, sharecroppers and mill hands, were afflicted annually with pellagra, a mysterious and frequently fatal disease characterized by skin lesions, delirium, and gastrointestinal disturbances (1). Each flood of the Mississippi River or collapse in the price of cotton pushed up the incidence. As fatalities rose, Joseph Goldberger, an up-and-coming bacteriologist in the US Public Health Service, assigned in 1914 to investigate the growing epidemic, concluded that the widely accepted infectious etiology was incorrect. Through careful field work in prisons and orphanages, Goldberger provided strong evidence for an underlying dietary deficiency (1–7). To convince the scientific public that pellagra was not transmissible, Goldberger, his coworkers, and his wife received injections of blood and excrement from affected prisoners. That none of them came down with pellagra is part of the saga, but that they escaped hepatitis or syphilis or some other common disease was indeed fortuitous. Because pellagra’s victims were poor and socially unconnected, Goldberger’s original cure, a diet rich in lean meat, eggs, and milk, was considered unacceptable because it was too expensive. Returning to the federal government’s Hygienic Laboratory in Washington, Goldberger validated a model of the disease in dogs and showed that brewer’s yeast, at pennies a day, could do as well as the expensive diet. Political barriers, however, impeded the adoption of this inexpensive remedy. The result was that the total conquest of pellagra was delayed until 25 years after Goldberger’s discovery of a cure and ten years after his death. Alan Kraut’s book is a skilled recounting of Goldberger’s life and complements nicely Elizabeth W. Etheridge’s 1972 masterpiece, The butterfly caste: the social history of pellagra (3). Kraut recounts how Goldberger’s achievements with pellagra garnered international recognition, including support for a Nobel Prize. Unfortunately, Goldberger died from cancer in January 1929, so his nomination was disqualified. Goldberger would have been a perfect companion to Christiaan Eijkman and Frederick G. Hopkins, who were selected for the Nobel Prize later that year for their work on vitamins. Kraut mourns the vacancy, the empty third slot in that 1929 Nobel Prize. A report of the archival records of the Nobel Committee’s deliberations would have been a worthwhile addition to this book. That third slot should be declared a perpetual memorial to Goldberger, who, in 15 years of total commitment, uncovered the cause of pellagra and introduced successful prevention and a cure. Goldberger was a model research leader, revered by his colleagues who shared in his achievements. The research accomplishments of Goldberger and his colleagues, some of whom later became medical leaders, touch many still-relevant issues: the effects of poverty on medical care and medical research, the role of politics in altering the course of new therapies, and the ethical challenges of research. Also relevant are rules for researchers performing experiments on themselves and the dangers of investigating infectious diseases. Goldberger survived yellow fever and dengue and almost died of typhus, which reminds one of the present-day dangers facing health care workers in contact with patients with dangerous diseases such as ebola and SARS. Finally, Kraut uses the letters between Goldberger and his wife to highlight the ever-relevant struggles of professional versus family demands, the recurrent pain of months of separation, and the stresses of family finances on a dedicated but underpaid public servant. I also enjoyed following the story of the nine-year-old Goldberger as he emigrated with his family from a village at the fringes of the Austro-Hungarian Empire to New York’s Lower East Side. There, good luck and hard work got him through City College of New York and the Bellevue Hospital Medical College. Kraut concludes that the economics and social isolation of solo medical practice led Goldberger to seek a US government post. Turned down by the Navy, he accepted a commission in the US Marine Hospital Service, which became the US Public Health Service in 1912. This book also recalls the multiple subtle and overt instances of anti-Semitism that Goldberger endured, including the extreme prejudice practiced by the US Navy in the recruitment of officers. We are all indebted to the Navy for rejecting Goldberger and thus assuring his scientific and medical legacy. Instead of a history of a plague, Kraut presents a role model. Because of that, I recommend this book to every health care professional in his or her formative years. Curriculum committees often overvalue facts and neglect role models. It would be easy to remove 313 pages from today’s overstuffed medical curriculums and substitute this narrative of Goldberger’s life.

Pharmacogenomics in Drug Development and Regulatory Decision-making: the Genomic Data Submission (GDS) Proposal

PharmacogenomicsVol. 5, No. 1 Conference SceneFree AccessPharmacogenomics in Drug Development and Regulatory Decision-making: the Genomic Data Submission (GDS) ProposalRonald A Salerno and Lawrence J LeskoRonald A SalernoDirector, Worldwide Regulatory Affairs, Wyeth Research, Collegeville, PA 19426, USA. Search for more papers by this authorEmail the corresponding author at Salernr@wyeth.com and Lawrence J LeskoDirector, Office of Clinical Pharmacology and Biopharmaceutics, CDER, FDA, Maryland, USASearch for more papers by this authorPublished Online:28 Jan 2008https://doi.org/10.2217/14622416.5.1.25AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail FiguresReferencesRelatedDetailsCited ByRegulatory considerations for companion diagnostic devicesEunice Y Lee & Hsin-Chieh Jennifer Shen21 January 2015 | Biomarkers in Medicine, Vol. 9, No. 1Personalized Medicine in Vascular Medicine2 February 2015Personalized Medicine Basic Principles18 February 2014Pharmacogenomics in early-phase clinical developmentTal Burt & Savita Dhillon9 July 2013 | Pharmacogenomics, Vol. 14, No. 9Future Perspectives15 March 2013One Hundred Years of Drug Regulation: Where Do We Go from Here?Annual Review of Pharmacology and Toxicology, Vol. 53, No. 1Pharmacogenomics: where does Britain stand?John Hudson19 December 2011 | Pharmacogenomics, Vol. 13, No. 1European attitudes to gene therapy and pharmacogeneticsDrug Discovery Today, Vol. 16, No. 19-20Ubiquitin-Mediated Proteasomal Degradation of ABC Transporters: a New Aspect of Genetic Polymorphisms and Clinical ImpactsJournal of Pharmaceutical Sciences, Vol. 100, No. 9Studying Organ-Specific Toxicity Using Gene-Expression Profiling18 July 2011Development of Regulations for Submitting Pharmacogenomic Data to AuthoritiesEmerging New Technologies in Pharamcogenomics: Rapid SNP detection, molecular dynamic simulation, and QSAR analysis methods to validate clinically important genetic variants of human ABC Transporter ABCB1 (P-gp/MDR1)Pharmacology & Therapeutics, Vol. 126, No. 1Rapid and cost-effective SNP detection method: application of SmartAmp2 to pharmacogenomics researchYasumasa Mitani, Alexander Lezhava, Aki Sakurai, Akina Horikawa, Makoto Nagakura, Yoshihide Hayashizaki & Toshihisa Ishikawa15 July 2009 | Pharmacogenomics, Vol. 10, No. 7Perspectives on the Current State of Pharmacogenomics in Drug DevelopmentYAKUGAKU ZASSHI, Vol. 129, No. 1Application of Pharmacogenetics and Pharmacogenomics in Drug Development and Regulatory Review28 February 2013From Pharmacogenomics to Translational BiomarkersChapter 22 Pharmacogenomics for forensic toxicology in enabling personalized medicineRealizing the Promise of Pharmacogenomics: Opportunities and ChallengesBiotechnology Law Report, Vol. 26, No. 3Incorporating Pharmacogenomics into Practice30 June 2016 | Journal of Pharmacy Practice, Vol. 20, No. 3Current impact of gene technology on healthcareHealth Policy, Vol. 80, No. 2Overview of Sources of New DrugsExperience with voluntary and required genomic data submissions to the FDA: summary report from track 1 of the third FDA-DIA-PWG-PhRMA-BIO pharmacogenomics workshop28 March 2006 | The Pharmacogenomics Journal, Vol. 6, No. 5A regulatory perspective on in vitro diagnosticsNature Biotechnology, Vol. 24, No. 8Regulatory Perspectives on Pharmacogenomics: A Review of the Literature on Key Issues Faced by the United States Food and Drug Administration18 August 2016 | Medical Care Research and Review, Vol. 63, No. 3Three years of promise, proposals, and progress on optimizing the benefit/risk of medicines: a commentary on the 3rd FDA-DIA-PWG-PhRMA-BIO pharmacogenomics workshop10 January 2006 | The Pharmacogenomics Journal, Vol. 6, No. 2Application of Pharmacogenomics in Clinical Pharmacology9 October 2008 | Toxicology Mechanisms and Methods, Vol. 16, No. 2-3Genetic polymorphisms of ATP-binding cassette transporters ABCB1 and ABCG2: therapeutic implications31 October 2005 | Expert Opinion on Pharmacotherapy, Vol. 6, No. 14Pharmacogenomics of the human ABC transporter ABCG2: from functional evaluation to drug molecular design14 September 2005 | Naturwissenschaften, Vol. 92, No. 10Regulatory Perspectives on Pharmacogenomics17 December 2009Pharmacogenetics-based therapeutic recommendations — ready for clinical practice?Nature Reviews Drug Discovery, Vol. 4, No. 8Measuring the value of pharmacogenomics24 May 2005 | Nature Reviews Drug Discovery, Vol. 4, No. 6Pharmacogenomics and the Drug Discovery PipelineAmerican Journal of PharmacoGenomics, Vol. 5, No. 1Availability of pharmacogenomics-based prescribing information in drug package inserts for currently approved drugs12 October 2004 | The Pharmacogenomics Journal, Vol. 4, No. 6Translation of pharmacogenomics and pharmacogenetics: a regulatory perspectiveNature Reviews Drug Discovery, Vol. 3, No. 9Guest Editorial: Regulatory Acceptance of Toxicogenomics DataEnvironmental Health Perspectives, Vol. 112, No. 12Pharmacogenomic data: FDA voluntary and required submission guidanceRonald A Salerno, Lawrence J Lesko5 November 2004 | Pharmacogenomics, Vol. 5, No. 5Pharmacogenomic data submissions to the FDA: non-clinical case studiesJohn K Leighton, Joseph DeGeorge, David Jacobson-Kram, James MacGregor, Donna Mendrick, Alexandra Worobec5 November 2004 | Pharmacogenomics, Vol. 5, No. 5Pharmacogenomic data submissions to the FDA: clinical pharmacology case studiesGualberto Ruaño, Jerry M Collins, Andrew J Dorner, Sue-Jane Wang, Roberto Guerciolini, Shiew-Mei Huang5 November 2004 | Pharmacogenomics, Vol. 5, No. 5Pharmacogenomic data submissions to the FDA: clinical case studiesWilliam L Trepicchio, Grant A Williams, David Essayan, Sue T Hall, Lea C Harty, Peter M Shaw, Brian B Spear, Sue Jane Wang, Mark L Watson5 November 2004 | Pharmacogenomics, Vol. 5, No. 5Pharmacogenomics and variation in drug therapy Vol. 5, No. 1 Follow us on social media for the latest updates Metrics Downloaded 283 times History Published online 28 January 2008 Published in print January 2004 Information© Future Medicine LtdPDF download

Pharmacogenomics in Drug Development and Regulatory Decision-making: the Genomic Data Submission (GDS) Proposal.

PharmacogenomicsVol. 5, No. 1 Conference SceneFree AccessPharmacogenomics in Drug Development and Regulatory Decision-making: the Genomic Data Submission (GDS) ProposalRonald A Salerno and Lawrence J LeskoRonald A SalernoDirector, Worldwide Regulatory Affairs, Wyeth Research, Collegeville, PA 19426, USA. Search for more papers by this authorEmail the corresponding author at Salernr@wyeth.com and Lawrence J LeskoDirector, Office of Clinical Pharmacology and Biopharmaceutics, CDER, FDA, Maryland, USASearch for more papers by this authorPublished Online:28 Jan 2008https://doi.org/10.2217/14622416.5.1.25AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail FiguresReferencesRelatedDetailsCited ByRegulatory considerations for companion diagnostic devicesEunice Y Lee & Hsin-Chieh Jennifer Shen21 January 2015 | Biomarkers in Medicine, Vol. 9, No. 1Personalized Medicine in Vascular Medicine2 February 2015Personalized Medicine Basic Principles18 February 2014Pharmacogenomics in early-phase clinical developmentTal Burt & Savita Dhillon9 July 2013 | Pharmacogenomics, Vol. 14, No. 9Future Perspectives15 March 2013One Hundred Years of Drug Regulation: Where Do We Go from Here?Annual Review of Pharmacology and Toxicology, Vol. 53, No. 1Pharmacogenomics: where does Britain stand?John Hudson19 December 2011 | Pharmacogenomics, Vol. 13, No. 1European attitudes to gene therapy and pharmacogeneticsDrug Discovery Today, Vol. 16, No. 19-20Ubiquitin-Mediated Proteasomal Degradation of ABC Transporters: a New Aspect of Genetic Polymorphisms and Clinical ImpactsJournal of Pharmaceutical Sciences, Vol. 100, No. 9Studying Organ-Specific Toxicity Using Gene-Expression Profiling18 July 2011Development of Regulations for Submitting Pharmacogenomic Data to AuthoritiesEmerging New Technologies in Pharamcogenomics: Rapid SNP detection, molecular dynamic simulation, and QSAR analysis methods to validate clinically important genetic variants of human ABC Transporter ABCB1 (P-gp/MDR1)Pharmacology & Therapeutics, Vol. 126, No. 1Rapid and cost-effective SNP detection method: application of SmartAmp2 to pharmacogenomics researchYasumasa Mitani, Alexander Lezhava, Aki Sakurai, Akina Horikawa, Makoto Nagakura, Yoshihide Hayashizaki & Toshihisa Ishikawa15 July 2009 | Pharmacogenomics, Vol. 10, No. 7Perspectives on the Current State of Pharmacogenomics in Drug DevelopmentYAKUGAKU ZASSHI, Vol. 129, No. 1Application of Pharmacogenetics and Pharmacogenomics in Drug Development and Regulatory Review28 February 2013From Pharmacogenomics to Translational BiomarkersChapter 22 Pharmacogenomics for forensic toxicology in enabling personalized medicineRealizing the Promise of Pharmacogenomics: Opportunities and ChallengesBiotechnology Law Report, Vol. 26, No. 3Incorporating Pharmacogenomics into Practice30 June 2016 | Journal of Pharmacy Practice, Vol. 20, No. 3Current impact of gene technology on healthcareHealth Policy, Vol. 80, No. 2Overview of Sources of New DrugsExperience with voluntary and required genomic data submissions to the FDA: summary report from track 1 of the third FDA-DIA-PWG-PhRMA-BIO pharmacogenomics workshop28 March 2006 | The Pharmacogenomics Journal, Vol. 6, No. 5A regulatory perspective on in vitro diagnosticsNature Biotechnology, Vol. 24, No. 8Regulatory Perspectives on Pharmacogenomics: A Review of the Literature on Key Issues Faced by the United States Food and Drug Administration18 August 2016 | Medical Care Research and Review, Vol. 63, No. 3Three years of promise, proposals, and progress on optimizing the benefit/risk of medicines: a commentary on the 3rd FDA-DIA-PWG-PhRMA-BIO pharmacogenomics workshop10 January 2006 | The Pharmacogenomics Journal, Vol. 6, No. 2Application of Pharmacogenomics in Clinical Pharmacology9 October 2008 | Toxicology Mechanisms and Methods, Vol. 16, No. 2-3Genetic polymorphisms of ATP-binding cassette transporters ABCB1 and ABCG2: therapeutic implications31 October 2005 | Expert Opinion on Pharmacotherapy, Vol. 6, No. 14Pharmacogenomics of the human ABC transporter ABCG2: from functional evaluation to drug molecular design14 September 2005 | Naturwissenschaften, Vol. 92, No. 10Regulatory Perspectives on Pharmacogenomics17 December 2009Pharmacogenetics-based therapeutic recommendations — ready for clinical practice?Nature Reviews Drug Discovery, Vol. 4, No. 8Measuring the value of pharmacogenomics24 May 2005 | Nature Reviews Drug Discovery, Vol. 4, No. 6Pharmacogenomics and the Drug Discovery PipelineAmerican Journal of PharmacoGenomics, Vol. 5, No. 1Availability of pharmacogenomics-based prescribing information in drug package inserts for currently approved drugs12 October 2004 | The Pharmacogenomics Journal, Vol. 4, No. 6Translation of pharmacogenomics and pharmacogenetics: a regulatory perspectiveNature Reviews Drug Discovery, Vol. 3, No. 9Guest Editorial: Regulatory Acceptance of Toxicogenomics DataEnvironmental Health Perspectives, Vol. 112, No. 12Pharmacogenomic data: FDA voluntary and required submission guidanceRonald A Salerno, Lawrence J Lesko5 November 2004 | Pharmacogenomics, Vol. 5, No. 5Pharmacogenomic data submissions to the FDA: non-clinical case studiesJohn K Leighton, Joseph DeGeorge, David Jacobson-Kram, James MacGregor, Donna Mendrick, Alexandra Worobec5 November 2004 | Pharmacogenomics, Vol. 5, No. 5Pharmacogenomic data submissions to the FDA: clinical pharmacology case studiesGualberto Ruaño, Jerry M Collins, Andrew J Dorner, Sue-Jane Wang, Roberto Guerciolini, Shiew-Mei Huang5 November 2004 | Pharmacogenomics, Vol. 5, No. 5Pharmacogenomic data submissions to the FDA: clinical case studiesWilliam L Trepicchio, Grant A Williams, David Essayan, Sue T Hall, Lea C Harty, Peter M Shaw, Brian B Spear, Sue Jane Wang, Mark L Watson5 November 2004 | Pharmacogenomics, Vol. 5, No. 5Pharmacogenomics and variation in drug therapy Vol. 5, No. 1 Follow us on social media for the latest updates Metrics Downloaded 822 times History Published online 28 January 2008 Published in print January 2004 Information© Future Medicine LtdPDF download

Informed consent/assent in children. Statement of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP).

Informed consent means approval of the legal representative of the child and/or of the competent child for medical interventions following appropriate information. National legal regulations differ in regard to the question when a child has the full right to give his or her autonomous consent. Informed assent means a child's agreement to medical procedures in circumstances where he or she is not legally authorised or lacks sufficient understanding for giving consent competently. Doctors should carefully listen to the opinion and wishes of children who are not able to give full consent and should strive to obtain their assent. Doctors have the responsibility to determine the ability and competence of the child for giving his or her consent or assent. All children, even those not judged as competent, have a right to receive information given in a way that they can understand and give their assent or dissent. This consent/assent process must promote and protect the dignity, privacy and confidentiality of the child and his or her family. Consent or assent is required for all aspects of medical care, for preventive, diagnostic or therapeutic measures and research. Children may effectively refuse treatment or procedures which are not necessary to save their lives or prevent serious harm. Where treatment is necessary to save a life or prevent serious harm, the doctor has the duty to act in the best interest of the child. However, parents may also refuse to consent and in this case national laws and legal mechanisms for resolving disputes may be used.

Evidence-Based Reproductive Medicine

[[author photo]]Medical practice is more satisfying when clinicians can be confident that their actions and advice are based on the best evidence. Of course, clinical decisions also require doctors to make use of experience and common sense. There is plenty of scope for the use of both evidence and judgment: the average reproductive medicine consultation involves discussions about etiology and prognosis, decisions about diagnosis and therapy, and counseling about costs and side effects. On each point, the principles of evidence-based medicine provide a guide to the quality of the relevant medical care research. Inevitably, however, the application of this evidence must be tailored to the circumstances and needs of individual patients.

Evaluating systematic reviews and meta-analyses.

Systematic review and meta-analysis procedures make use of explicit methods to methodically search and critically appraise and synthesize the medical care research literature. The methods involve refining a clinical question, designing a search procedure to find eligible studies, and determining the validity of the eligible studies. Independent data extraction by two or more reviewers is preferred. Agreement between the reviewers with respect to relevance and validity should be measured. Meta-analysis procedures estimate an overall average effect from the individual study effects and determine whether these effects appear to measure the same relationship (that is, the studies are not heterogeneous). In the inverse variance method, which is most frequently applied, the overall effect is a weighted average of the individual study effects, where each weight is the inverse of the study variance. To evaluate a systematic review, first determine whether it addresses a question that is relevant to the patients, treatments, and outcomes that are usual in your clinical practice. Then assess the validity of the systematic review, which is reflected by quality of the individual studies, the rigor with which the systematic methods were applied, and the extent of heterogeneity. If the results of the systematic review are valid, then is the effect important enough to make a difference in your clinical practice? Applying the results to an individual patient involves the absolute treatment effect or the number needed to treat, and an awareness of the patient's specific level of risk and personal preferences.

Commentary on Majumdar et al.: Mindfulness Meditation for Health

The Journal of Alternative and Complementary MedicineVol. 8, No. 6 Original PapersCommentary on Majumdar et al.: Mindfulness Meditation for HealthJon Kabat-ZinnJon Kabat-ZinnSearch for more papers by this authorPublished Online:5 Jul 2004https://doi.org/10.1089/10755530260511739AboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail FiguresReferencesRelatedDetailsCited byMindful Versus Diaphragmatic Breathing: Spirituality Moderates the Impact on Heart Rate Variability20 September 2021 | Mindfulness, Vol. 12, No. 11Happiness and Its Association with Mindfulness: A Non-systematic Review31 August 2021 | Journal of Mahatma Gandhi University of Medical Sciences and Technology, Vol. 6, No. 1Rumination and valued living in women with chronic pain: How they relate to the link between mindfulness and depressive symptoms26 November 2018 | Current Psychology, Vol. 40, No. 3Self-Compassion and Depressive Symptoms in Chronic Pain (CP): A 1-Year Longitudinal Study19 December 2019 | Mindfulness, Vol. 11, No. 3Perceived stress mediates the relationship between mindfulness and negative affect variability: A randomized controlled trial among middle-aged to older adults20 November 2018 | Stress and Health, Vol. 35, No. 1Innovating Through Reflective Learning in Mindful OrganizationsMindfulness, selfcompassion, and depressive symptoms in chronic pain: The role of pain acceptance13 August 2018 | Journal of Clinical Psychology, Vol. 74, No. 12Cognitive Processing Styles and Mindfulness on Pain Intensity Prediction in People with Primary Headache19 November 2018 | Anesthesiology and Pain Medicine, Vol. 8, No. 6Posttraumatic Stress Disorder (PTSD)T'ai Chi Chih—An Evidence-Based Mindfulness Practice: Literature Review Marilyn Anita Vestal1 August 2017 | Alternative and Complementary Therapies, Vol. 23, No. 4Mind–Body Interventions for Irritable Bowel Syndrome Patients in the Chinese Population: a Systematic Review and Meta-Analysis19 September 2016 | International Journal of Behavioral Medicine, Vol. 24, No. 2The Role of Individual and Collective Mindfulness in Promoting Occupational Safety in Health Care3 August 2016 | Medical Care Research and Review, Vol. 74, No. 1TTAi Chi Chih, an Evidence Based Mindfulness Practice: Literature ReviewSSRN Electronic Journal, Vol. 9Studies in mindfulness: widening the field for all involved in pastoral care3 August 2016 | Pastoral Care in Education, Vol. 34, No. 3The Body Scan and Mindful Breathing Among Veterans with PTSD: Type of Intervention Moderates the Relationship Between Changes in Mindfulness and Post-treatment Depression20 October 2015 | Mindfulness, Vol. 7, No. 2Mindfulness-based Stress Reduction in Addition to Usual Care Is Associated with Improvements in Pain, Fatigue, and Cognitive Failures Among Veterans with Gulf War IllnessThe American Journal of Medicine, Vol. 129, No. 2The Role of Perceived Stress and Health Beliefs on College Students' Intentions to Practice Mindfulness Meditation8 January 2016 | American Journal of Health Education, Vol. 47, No. 1Loving-Kindness Meditation for Posttraumatic Stress Disorder: A Pilot Study25 July 2013 | Journal of Traumatic Stress, Vol. 26, No. 4Effects of Participation in a Mindfulness Program for Veterans With Posttraumatic Stress Disorder: A Randomized Controlled Pilot Study28 August 2012 | Journal of Clinical Psychology, Vol. 69, No. 1Participation in mindfulness-based stress reduction is not associated with reductions in emotional eating or uncontrolled eatingNutrition Research, Vol. 32, No. 6Association of participation in a mindfulness programme with bowel symptoms, gastrointestinal symptom-specific anxiety and quality of life9 June 2011 | Alimentary Pharmacology & Therapeutics, Vol. 34, No. 3The Influence of a Spirituality-Based Intervention on Quality of Life, Depression, and Anxiety in Community-Dwelling Adults With Cardiovascular Disease16 August 2010 | Journal of Holistic Nursing, Vol. 29, No. 1Low mindfulness predicts pain catastrophizing in a fear-avoidance model of chronic painPain, Vol. 148, No. 1EcospiritualityHolistic Nursing Practice, Vol. 23, No. 6Complementary and alternative medicine for IBS in adults: mind–body interventions30 September 2008 | Nature Clinical Practice Gastroenterology & Hepatology, Vol. 5, No. 11 Volume 8Issue 6Dec 2002 To cite this article:Jon Kabat-Zinn.Commentary on Majumdar et al.: Mindfulness Meditation for Health.The Journal of Alternative and Complementary Medicine.Dec 2002.731-735.http://doi.org/10.1089/10755530260511739Published in Volume: 8 Issue 6: July 5, 2004PDF download

Between iatrotropic stimulus and interiatric referral:: the domain of primary care research

The “iatrotropic stimulus” is a typical example of Alvan Feinstein's terminology and his clinical way of thinking about medical research. Feinstein specified “interiatric referral” as an additional important factor affecting “the likelihood that patients will appear at the particular setting in which research is being conducted.” He emphasized these phenomena as highly relevant for clinical judgment, clinical research, and clinical epidemiology. This has stimulated the realization of original clinical research in international primary medical care. It has helped to recognize the characteristics of the spectrum of health problem and morbidity patterns presented to primary care physicians and to acknowledge the position of generalistic primary care research between open population research and clinical research in referred (specialist) care. Accordingly, primary care-specific challenges in investigating (early) diagnosis, prognosis, treatment, and referral decisions have emerged. This research supports adequate decision-making by the primary care physician, which is important for effective health care. Although Feinstein was a clinical specialist and has always lived in a country without a very strong primary care tradition, he not only recognized the value of primary care research but also substantially contributed to its development.

Validación de las versiones en español de la Montgomery-Asberg Depression Rating Scale y la Hamilton Anxiety Rating Scale para la evaluación de la depresión y de la ansiedad

Affective and anxiety disorders (AfD & AnD) are the most common psychiatric diseases in the general population. This study's aim was to assess for the first time the psychometric properties of the Spanish translated versions of the Montgomery-Asberg Depression Rating Scale (MADRS) and the Hamilton Anxiety Rating Scale (HARS), which are widely used both in medical care and clinical research. A cohort, observational, prospective and multicentre study was conducted in clinically stable or unstable patients with AfD and AnD. The scales were administered at baseline and in a second study visit one week or 2 months later (to stable or unstable patients, respectively). The internal consistency, temporary stability, inter-raters reliability, factorial structure, convergent and discriminant validity, and sensitivity to change were all assessed for both scales. One hundred and eight AfD patients and 106 AnD patients were recruited in 10 psychiatry care centres from a wide geographical distribution. Both scales showed adequate properties in terms of: a) discriminant validity (MADRS/HARS-Clinical Global Impression: p < 0.001); b) convergent validity (MADRS-Hamilton Depression Rating Scale: p < 0.05 and 0.01; MADRS/HARS-EuroQoL 5D: p < 0.05; HARS-State Trait Anxiety Inventory: p < 0.05); c) internal consistency (Cronbach's alpha: MADRS = 0.88; HARS = 0.89); d) test-retest and inter-raters reliability (intraclass correlation coefficient: MADRS = 0.94 and 0.98, respectively; HARS = 0.92 and 0.92), and, e) sensitivity to change (effect size: MADRS = 2.05; HARS = 1.36). Spanish versions of MADRS and HARS scales showed good psychometric properties, similar to those of the original scales. Therefore, these scales are suitable for use in clinical practice and research in Spain.

Prospective multi-center study colon/rectum carcinoma (primary tumors)--Results of the year 2000

Surgical quality control in the form of multicentre studies make it possible to analyse the treatment status of a given surgical illness under quality assurance aspects. On 1. 1. 2000, under the patronage of the Convent of Hospital Chief Surgeons a project (ongoing) - organised and conducted by the Institute for Quality Management in Operative Medicine at the Otto-von-Guericke University of Magdeburg - was initiated to document and collect the data of patients with colorectal cancer throughout the whole of Germany. This work is supported by the German Society of Surgery, and the Surgical Working Group, Quality Assurance within the German Society of Surgery. Currently, some 282 hospitals throughout the country are involved in establishing a prospective documentation of colorectal carcinoma. Participation in this study is on a voluntary basis. The anonymity of both patients and hospitals is guaranteed, and no hospitals wishing to participate are excluded. Both operatively and conservatively treated patients are being documented, and no randomization takes place. In the year 2000, the participating hospitals documented a total of 9 477 patients with a colorectal carcinoma, including 6 975 patients with a carcinoma of the colon, and 3 402 with a rectal carcinoma. The average age of the patients was 68.5 years, and there were 5 010 men and 4 467 women. The operation rate was 99.2 %, the resection rate 95.6 %. The abdominoperineal resection rate was 27.4 %. The indicators for diagnostic quality as set out by Hermanek were largely complied with, but some deviations were noted. On the basis of the data collected, structures were established for a uniform Germany-wide quality management for a clinical condition with a major health policy impact. This information make it possible for the hospitals to identify and eliminate deficits in the structural and process quality in the diagnosis and treatment of colorectal cancer, and in this way to improve outcome quality. This means that the results of medical care research have an immediate impact on the individual treatment received by a given patient.

Overview: PPO Performance Measurement: Agenda for the Future

This special issue of Medical Care Research and Review features articles developed for a national conference on performance measurement in preferred provider organizations (PPOs). The conference, “PPO Performance Measurement: Agenda for the Future,” was held March 15-16, 2001, in Washington, D.C. It brought together various stake-holders—industry representatives, consumers, purchasers, and regulators—to discuss the state of PPO performance reporting and develop a strategy for future directions. These articles provided the background for an informed dialogue. The American Accreditation HealthCare Commission (URAC), the Consumer Coalition for Quality HealthCare, the Joint Commission on Accreditation of Healthcare Organizations, and the National Committee for Quality Assurance cosponsored the conference with a grant from the Agency for Healthcare Research and Quality to URAC.

Index to Medical Care Research and Review

Index to Medical Care Research and Review

Overview: PPO Performance Measurement: Agenda for the Future

This special issue of Medical Care Research and Review features articles developed for a national conference on performance measurement in preferred provider organizations (PPOs). The conference, “PPO Performance Measurement: Agenda for the Future,” was held March 15-16, 2001, in Washington, D.C. It brought together various stake-holders—industry representatives, consumers, purchasers, and regulators—to discuss the state of PPO performance reporting and develop a strategy for future directions. These articles provided the background for an informed dialogue. The American Accreditation HealthCare Commission (URAC), the Consumer Coalition for Quality HealthCare, the Joint Commission on Accreditation of Healthcare Organizations, and the National Committee for Quality Assurance cosponsored the conference with a grant from the Agency for Healthcare Research and Quality to URAC.

Corporate health care purchasing among Fortune 500 firms.

Trends Health AffairsVol. 20, No. 3: Lessons From Abroad TRENDSCorporate Health Care Purchasing Among Fortune 500 FirmsJames Maxwell, Peter Temin, and Corey WattsPUBLISHED:May/June 2001No Accesshttps://doi.org/10.1377/hlthaff.20.3.181AboutSectionsView articleView Full TextView PDFPermissions ShareShare onFacebookTwitterLinked InRedditEmail ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions View articleTOPICSQuality of careManaged carePremiumsHealth benefitsIndemnitiesHealth maintenance organizationsQuality measurementPrivate health insuranceQuality improvementCost containment Loading Comments... Please enable JavaScript to view the comments powered by Disqus. DetailsExhibitsReferencesRelated Article MetricsCitations: Crossref 26 History Published online 1 May 2001 InformationCopyright 2001 by Project HOPE - The People-to-People Health Foundation, Inc.PDF downloadCited by"Choose the Plan That’s Right for You": Choice Devolution as Class-Biased Institutional Change in U.S. Employer-Sponsored Health Insurance1 January 2022 | Sociological Science, Vol. 9Red, blue, and purple firms: Organizational political ideology and corporate social responsibility21 July 2016 | Strategic Management Journal, Vol. 38, No. 5Do Leveraged Firms Underinvest in Corporate Social Responsibility? Evidence from Health and Safety Programs in U.S. Firms13 December 2014 | Journal of Business Ethics, Vol. 135, No. 4Let Them Have Choice: Gains from Shifting Away from Employer-Sponsored Health Insurance and Toward an Individual ExchangeAmerican Economic Journal: Economic Policy, Vol. 5, No. 1Competitive bidding for health insurance contracts: lessons from the online HMO auctions6 December 2012 | International Journal of Health Care Finance and Economics, Vol. 12, No. 4Sleight of Hand? Practice Opacity, Third-party Responses, and the Interorganizational Diffusion of Controversial Practices16 October 2012 | Administrative Science Quarterly, Vol. 57, No. 4Are Leveraged Firms Focused on the Short-Run? Evidence from Health and Safety Programs in U.S. FirmsSSRN Electronic JournalThe $640 Billion Question — Why Does Cost-Effective Care Diffuse So Slowly?New England Journal of Medicine, Vol. 364, No. 21The Nixon-in-China Effect: Activism, Imitation, and the Institutionalization of Contentious Practices1 September 2008 | Administrative Science Quarterly, Vol. 53, No. 3Hospital Responses to the Leapfrog Group in Local Markets28 November 2007 | Medical Care Research and Review, Vol. 65, No. 2Healthcare marketing: what is salient?International Journal of Pharmaceutical and Healthcare Marketing, Vol. 1, No. 3A Physicians' Agenda for Partnering With Employers and Insurers: Fresh IdeasMayo Clinic Proceedings, Vol. 81, No. 12Policymaker use of quality of care information21 July 2005 | International Journal for Quality in Health Care, Vol. 17, No. 6Why Employers Need To Rethink How They Buy Health CareRobert S. Galvin and Suzanne Delbanco2 August 2017 | Health Affairs, Vol. 24, No. 6Are California's Large Employers Moving To Catastrophic Health Insurance Coverage? Results from a study of large California employers finds that high-deductible PPOs and consumer-driven plans are making inroads but are nowhere near dominant.James Maxwell, Peter Temin, Saminaz Zaman, and Tanaz Petigara5 June 2018 | Health Affairs, Vol. 24, No. Suppl1Commentary on “Opportunities and Challenges for Measuring Cost, Quality, and Clinical Effectiveness in Health Care”: The Fault Lies Not in our Stars but in Our System16 November 2016 | Medical Care Research and Review, Vol. 61, No. 3_supplPrivate Health Purchasing Practices In The Public Sector: A Comparison Of State Employers And The Fortune 500James Maxwell, Peter Temin, and Tanaz Petigara2 August 2017 | Health Affairs, Vol. 23, No. 2Corporate contracting for health careJournal of Economic Behavior & Organization, Vol. 52, No. 3The End of an Era: What Became of the "Managed Care Revolution" in 2001?Health Services Research, Vol. 38, No. 1p2Managing Costs, Managing Benefits: Employer Decisions in Local Health Care MarketsHealth Services Research, Vol. 38, No. 1p2Corporate Management of Quality in Employee Health PlansHealth Care Management Review, Vol. 28, No. 1Voices Unheard: Barriers to Expressing Dissatisfaction to Health PlansMilbank Quarterly, Vol. 80, No. 4Association Between Health Insurance Coverage of Office Visit and Cancer Screening Among WomenMedical Care, Vol. 40, No. 11Obstacles To Employers’ Pursuit Of Health Care QualityJ. Lee Hargraves and Sally Trude17 August 2017 | Health Affairs, Vol. 21, No. 5The Benefits Divide: Health Care Purchasing In Retail Versus Other SectorsJames Maxwell, Peter Temin, and Saminaz Zaman17 August 2017 | Health Affairs, Vol. 21, No. 5The Evolution of Quality Management in State Medicaid Agencies: A National Survey of States with Comprehensive Managed Care ProgramsThe Joint Commission Journal on Quality Improvement, Vol. 28, No. 2

Providing care at the end of life: do Medicare rules impede good care?

Providing care at the end of life: do Medicare rules impede good care?