Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe: executive summary.

The evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical evaluation pathway for market approval. The two-stage clinical evaluation plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report.

Mechanical thrombectomy in acute ischemic stroke: Consensus statement by ESO-Karolinska Stroke Update 2014/2015, supported by ESO, ESMINT, ESNR and EAN

The original version of this consensus statement on mechanical thrombectomy was approved at the European Stroke Organisation (ESO)-Karolinska Stroke Update conference in Stockholm, 16-18 November 2014. The statement has later, during 2015, been updated with new clinical trials data in accordance with a decision made at the conference. Revisions have been made at a face-to-face meeting during the ESO Winter School in Berne in February, through email exchanges and the final version has then been approved by each society. The recommendations are identical to the original version with evidence level upgraded by 20 February 2015 and confirmed by 15 May 2015. The purpose of the ESO-Karolinska Stroke Update meetings is to provide updates on recent stroke therapy research and to discuss how the results may be implemented into clinical routine. Selected topics are discussed at consensus sessions, for which a consensus statement is prepared and discussed by the participants at the meeting. The statements are advisory to the ESO guidelines committee. This consensus statement includes recommendations on mechanical thrombectomy after acute stroke. The statement is supported by ESO, European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), and European Academy of Neurology (EAN).

Anadromous Rainbow Smelt and Tomcod in Connecticut: Assessment of populations, conservation status, and need for restoration plan

(beginning of rainbow smelt executive summary) Evidence indicates that anadromous rainbow smelt (Osmerus mordax) populations in Connecticut and elsewhere in the northeast United States have severely declined. Several sampling programs have documented declines in Connecticut’s smelt populations over the last three decades (Marcy 1976a, Marcy 1976b, Millstone Environmental Laboratory 2005). Similar declines have also been documented in the Hudson River (ASA Analysis & Communication 2005) and in Massachusetts (personal communication, Brad Chase, MA Division of Marine Fisheries 2004). Recreational and commercial fisheries in the region for this species have virtually ceased (Blake and Smith 1984). The Connecticut Fish Advisory Committee of the Endangered Species Program has recommended that rainbow smelt be listed as threatened in Connecticut, and the National Marine Fisheries Service (2004) has recently listed rainbow smelt as a Federal Species of Concern. The purpose of this project is to develop an environmental history of rainbow smelt in Connecticut and surrounding regions, and document the current status of populations in Connecticut waters. An environmental history that assesses trends in abundance, environmental threats and historical efforts to ameliorate the threats will contribute to regional efforts to conserve these fish. Comprehensive review of the regional literature and trends associated with rainbow smelt has not been undertaken since Kendall (1926). Assessment of current abundance, distribution, areas of critical habitat, and whether the species is presently reproducing in state waters is critical for clarifying conservation status, designing a monitoring program and developing a recovery or enhancement plan, if this appears to be necessary. (beginning of tomcod executive summary) Atlantic tomcod (Microgadus tomcod) are believed to have declined significantly in Connecticut and other estuaries of the Northeast and Middle Atlantic states. Several monitoring programs indicate that the species is scarce and/or declining in the region’s estuaries (Gottschall and Pacileo 2004, Molnar 2004, Millstone Environmental Laboratory 2005, ASA Analysis and Communication 2005). Once-active recreational (NMFS MRFSS 2005, http://www.st.nmfs.gov) and commercial fisheries for this species in Connecticut are now dormant. For the past 10 years, the Connecticut Fish Advisory Committee of the Endangered Species Program has recommended that studies be undertaken to quantify the status of tomcod populations and to determine if conservation actions should be initiated. The purpose of this project is to develop an environmental history of Atlantic tomcod in Connecticut and surrounding regions, and document the current status of populations in Connecticut waters. An environmental history that assesses trends in abundance, environmental threats and historical efforts to ameliorate the threats will contribute to regional efforts to conserve these fish. Assessment of current abundance, distribution, areas of critical habitat, and whether the species is presently reproducing in state waters is critical for determining conservation status, designing a monitoring program and developing a recovery or enhancement plan, if this appears to be necessary.

Na 1 Nachlass Max Horkheimer, 493 - Korrespondenzen mit Mitarbeitern (u.a. Gerhard Brand, Ludwig von Friedeburg und Jürgen Habermas) aus dem Institut für Sozialforschung (p. V 193, 1 - 212)

Briefe zwischen Mitarbeitern des Instituts für Sozialforschung und Max Horkheimer, 1964-1973; 13 Briefe und Beilagen zwischen dem Verwaltungsleiter IfS Siegfried Geissler und Max Horkheimer, 1968-1973; 9 Briefe zwischen Klaus Körber (Institut für Sozialforschung) und Max Horkheimer, 1971-1973; 2 Briefe zwischen dem Professor Rudolf Gunzert und Max Horkheimer, 1972; 2 Briefe zwischen Dr. Joachim Bergmann (Institut für Sozialforschung) und Max Horkheimer, 1971; 2 Briefe zwischen dem Professor Gerhard Brandt und Max Horkheimer, 1971; 6 Briefe zwischen Herbert Ludwig (Institut für Sozialforschung) und Max Horkheimer, 1966-1967; 3 Briefe von Max Horkheimer an Professor Franz Böhm, 1966; Briefe zwischen den Mitarbeitern des Instituts für Sozialforschung und Max Horkheimer, 1955-1959; 4 Briefe von Jürgen Habermas an Max Horkheimer, Frankfurt, 1957-1959; 3 Briefe zwischen Christoph Oehler und Max Horkheimer, 1959; 13 Briefe zwischen Ludwig von Friedeburg und Max Horkheimer, 1955-1959; 1 Brief von Werner Wilkening an Max Horkheimer, 1958; 1 Brief von Gerhard Brandt an Max Horkheimer, 1958; 1 Brief von Max Horkheimer an den Dekan Helmut Viebrock, 1958; 2 Briefe von Egon Becker mit Helge Pross und Ludwig Friedeburg an Max Horkheimer, Frankfurt, 1958-1959; 2 Briefe von Helge Pross mit Egon Becker und Ludwig Friedeburg an Max Horkheimer, Frankfurt, 1958-1959; 1 Brief von Dieter Arenz an Max Horkheimer, Frankfurt, 1956; Briefe vom und an das Institut für Sozialforschung (Advisory Board of the Institute of Social Research), 1940-1947; Briefe und Briefentwürfe an und von Mitgliedern des Advisory Board betreffend die Zusendung von Max Horkheimer "Eclipse of Reason" und Karl August Wittvogel/Olga Lang, "Chinese Family and Society"; vom Institut für Sozialforschung, 1946-1947; 1 Brief von Edwin Borchard vom Institut für Sozialforschung, 1947; 1 Brief von Friedrich Pollock an Alfred E. Cohn, Los Angeles, 1947; 1 Brief von Friedrich Pollock an Stephan Duggan, Los Angeles, 1947; 2 Briefe zwischen Lloyd K. Garrison und Friedrich. Pollock, 1947; 1 Brief von Friedrich Pollock an Calvin B. Hoover, Los Angeles, 1947; 1 Brief von Friedrich Pollock an Philip C. Jessup, Los Angeles, 1947; 1 Brief von Friedrich Pollock an Wesley C. Mitchell, Los Angeles, 1947; 1 Brief von Friedrich Pollock an William A. Neilson, Los Angeles, 1947; 1 Brief von Friedrich Pollock an Frederick M. Padelford, Los Angeles, 1947; 1 Brief von Friedrich Pollock an Thorsten Sellin, Los Angeles, 1947; 3 Briefe zwischen John Whyte und Friedrich Pollock, 1947; 2 Briefe zwischen Louis Wirth und Friedrich Pollock, 1947; 1 Brief von Friedrich Pollock an Howard Woolston, Los Angeles, 1947; 1 Brief von George H. Sabine an das Institut für Sozialforschung, Ithaca, New York, 1946; Briefe und Briefentwürfe an und von Mitgliedern des Advisory Board betreffend den Druck eines neuen Briefkopfs des Instituts, 1940; 1 Brief von Leo Löwenthal, Pacific Palisades an Margot von Mendelssohn, 1942; 1 Brief von Leo Löwenthal an Margot von Mendelssohn, Pacific Palisades, 1942; 1 Brief von Max Horkheimer an K. Pilser, 1942; 2 Briefe zwischen Charles A. Beard und Max Horkheimer, 1940; 2 Briefe zwischen Edwin M. Borchard und Max Horkheimer, 1940; 3 Briefe zwischen Henry Sloane Coffin und Max Horkheimer, 1940; 2 Briefe zwischen Morris R. Cohen und Max Horkheimer, 1940; 2 Briefe zwischen Alfred E. Cohn und Max Horkheimer, 1940; 2 Briefe zwischen Stephen Duggan und Max Horkheimer, 1940; 2 Briefe zwischen dem Soziologen Henry Pratt Fairchild und Max Horkheimer, 1940; 2 Briefe zwischen Sidney B. Fay und Max Horkheimer, 1940; 2 Briefe zwischen Lloyd K. Garrison und Max Horkheimer, 1940; 1 Brief von Max Horkheimer an Calvin B. Hoover, 1940; 2 Briefe zwischen Robert M. Hutchins und Max Horkheimer, 1940; 2 Briefe zwischen Philip C. Jessup und Max Horkheimer, 1940; 2 Briefe zwischen Lewis L. Lorwin und Max Horkheimer, 1940; 2 Briefe zwischen Robert S. Lynd und Max Horkheimer, 1940; 2 Briefe zwischen Robert M. MacIver und Max Horkheimer, 1940; 2 Briefe von Max Horkheimer an Charles H. McIlwain, 1940; 2 Briefe zwischen Charles E. Merriam und Max Horkheimer, 1940; 2 Briefe zwischen Wesley C. Mitchell und Max Horkheimer, 1940; 2 Briefe zwischen William A. Nielson und Max Horkheimer, 1940; 5 Briefe zwischen Howard W. Odum und Max Horkheimer, 1940; 3 Briefe zwischen Frederick M. Padelford und Max Horkheimer, 1940; 3 Briefe von Max Horkheimer an Max Radin, 1940; 2 Briefe zwischen George H. Sabine und Max Horkheimer, 1940; 2 Briefe zwischen Thorsten Sellin und Max Horkheimer, 1940; 2 Briefe zwischen James T. Shotwell und Max Horkheimer, 1940; 1 Brief von dem Soziologen Louis Wirth an Franz Neumann, Chicago, 1940; 1 Brief von Louis Wirth an Franz L. Neumann, Chicago, 1940; 3 Briefe zwischen Howard Woolston und Max Horkheimer, 1940;

Na 1 Nachlass Max Horkheimer, 656 - Dokumente zur Geschichte des Instituts für Sozialforschung (p. IX 49a-IX 55.1-5)

Max Horkheimer: Über Wissenschaft und Technologie in Israel. Begrüßungsrede für Mr. Ben Sira, gehalten am 8.1.1949; 1. Notizen zur Rede, 10 Blatt; 2. David Ben Gurion, "Science and Technology in Israel", Sonderdruck, 2 Blatt; Über die Antisemitismus-Forschungen des Instituts für Sozialforschung. Protokoll einer Sitzung der Frankfurter Gesellschaft für Christlich-Jüdische Zusammenarbeit, 16.Mai 1949. Typoskript (Kopie), 2 Blatt; Max Horkheimer: Über Arbeit und Pläne des Instituts für Sozialforschung in Frankfurt. Vortrag, gehalten 1949 in Frankfurt (Clubabend). Manuskript, 3 Blatt; Zur Begründung eines Instituts für Sozialforschung, 1922; 1. Senckenbergische Naturforschende Gesellschaft, Frankfurt: 1 Brief mit Unterschrift (Kopie) an die Universität Frankfurt, Kuratorium, Frankfurt, 22.8.1922; 2. Felix Weil und Kurt Albert Gerlach: "Denkschrift über die Begründung eines Instituts für Sozialforschung" (1922). Typoskript (Kopie), 5 Blatt; Carl Grünberg: Festrede, gehalten zur Einweihung des Instituts für Sozialforschung an der Universität Frankfurt am Main, am 22.6.1924. a) Kopie (Auszug) aus dem Abdruck der Rede in Frankfurter Universitätsreden 1924, 3 Blatt b) Sonderdruck Frankfurter Universitätsreden 1924, 16 Seiten; Darstellungen des Instituts für Sozialforschung (1925-51); 1. Gesellschaft für Sozialforschung, Frankfurt: "Institut für Sozialforschung an der Universität Frankfurt am Main". Sonderdruck (Kopie), Frankfurt, 1925, 29 Seiten; 1a. Hermann Weil: "Bericht über das Heimatfest in Waibstadt am 3. und 4. September und die feierliche Übergabge meines Mausoleums in den Schutz der Stadt Waibstadt". Sonderdruck, 1927, 7 Seiten; 1b. Felix Weil, 1 Brief mit Unterschrift (Kopie) an den Minister für Wissenschaft, Kunst und Volksbildung Berlin. Frankfurt, 1.11.1929, Typoskript, 31 Blatt; 1c. Columbia University: "Report of the President of Columbia University for 1934" (darin S.7: Erwähnung des Instituts für Sozialforschung und der Zeitschrift für Sozialforschung), Sonderdruck, New York, 1934, 80 Seiten; 2. "International Institute of Social Research: A short Description of Its History and Aims", New York 1935, Sonderdruck, 15 Seiten; 3. Briefbogen des Instituts für Sozialforschung mit den Namen des Research Staff und des Advisory Committee, 1 Blatt; 4. "International Institute of Social Research. A Report On Its History, Aims and Activities 1933-1938". Sonderdruck, New York 1939, 36 Seiten; 5. "Research Bureau For Post-War Economics and Its Cooperating Institutions. Annual Repost", Sonderdruck, New York, Mai 1939, 17 Seiten; 5a. Los Angeles University of Applied Education: "General Catalogue 1947-48" (mit Erwähnungen des Instituts für Sozialforschung bzw. von Mitarbeitern), Druck, 56 Seiten; 6. Einladung zur Eröffnung des Instituts für Sozialforschung am 14. November 1951. Sonderdruck, Frankfurt 1951, 2 Blatt; Über das Institut für Sozialforschung 1924-31. Tabellarische Zusammenstellung, 1931, Typoskript mit eigenhändigen und handschriftlichen Ergänzungen, 5 Blatt; Max Horkheimer: "Die gegenwärtige Lage der Sozialphilosophie und die Aufgaben eines Instituts für Sozialforschung". Öffentliche Antrittsvorlesung bei Übernahme des Lehrstuhls für Sozialphilosophie und der Leitung des Instituts für Sozialforschung, 24.1.1931, Kopie (Auszug) aus dem Abdruck der Rede in Frankfurter Universitätsreden 1931, 4 Blatt; "History and Program of the Institute of Social Research". Veröffentlicht unter dem Titel "International Institute of Social Research. A Short Description of Its History and Aims", New York (1934 od. 1935), Typoskript, 6 Blatt.; "A Digest of the History, Program and Needs of the International Institute of Social Research". 1934, als Typoskript vervielfältigt, 4 Blatt; Julian Gumperz: "Notes for a talk", Über Ziele und Methoden der Arbeit des Instituts für Sozialforschung, 1934. Typoskript mit handschriftlicher Korrektur, 10 Blatt; "Report of the President of Columbia University for the year ending June 30, 1934".Auszug daraus, 1934, Typoskript, 1 Blatt; Über Geschichte und Tätigkeiten des Instituts für Sozialforschung. Verschiedene Berichte, ca. 1934-1937: 1. Über Geschichte, Tätigkeiten und Ziele des Instituts, nicht vor 1934, Typoskript, 5 Blatt; 2. Bericht an den Präsidenten der Columbia University, 14.3.1936, Typoskript, 2 Blatt; 3. "Dr. Horkheimer's Paper Delivered on the Occasion of an Institute Luncheon Given to the Faculty of Social Sciences of Columbia University on January 12th, 1937". Typoskript, 13 Blatt; 4. Bericht an den Präsidenten der Columbia University. 18.3.1937, Typoskript, 3 Blatt; 5. Über Programm, Mitglieder und Tätigkeiten des Instituts, 1937, a) Typoskript, 2 Blatt, b) Entwurf, Typoskript, 4 Blatt; 6. Publikationsliste 1937, Typoskript, 1 Blatt; Über "Autorität und Familie" und die "Zeitschrift für Sozialforschung". 1937, Typoskript, französisch, mit eigenhändigen Korrekturen, 4 Blatt; Max Horkheimer: Über das Institut für Sozialforschung 1938: 1. Typoskript, englische Fassung, mit handschriftlichen Korrekturen, 38 Blatt; 2. Typoskript, deutsche Fassung mit eigenhändigen Korrekturen, 37 Blatt (G.S. 12, S. 132-164); 3. Julian Gumperz: 1 Brief an Herbert Marcuse, New York, 30.8.1938; 4. Teilstück aus früherer Fassung (?), Typoskript, 1 Blatt, 5. Entwurf zu 2., a) Typoskript, 1 Blatt, b) Typoskript mit eigenhändigen Korrekturen und Ergänzungen, 2 Blatt;

Na 1 Nachlass Max Horkheimer, 658 - Berichte über die Arbeit des Instituts für Sozialforschung u.a. (p. IX 59.3-IX 63)

Grossmann, Henrik: "The Nature of Economic Crisis". Typoskript, 4 Blatt; Über die Tätigkeiten des Institutes für Sozialforschung. Verschiedene Berichte. 1940- 1941; "Report to the Trustees of the Kurt Gerlach Memorial Foundation". 25.01.1940, Typoskript, 5 Blatt; "Manuskript under preparation". Januar 1940, handschriftliche Liste, 1 Blatt; Horkheimer, Max: "Über die allgemeine Lage des Instituts". Bericht für das Advisory Bord (New York members) Meeting, 22.04.1940; sowie ein Protokoll des Treffens, Typoskript, 5 Blatt; "Annual Report on the Activities of the Société International de Recherces Sociales, Presented to the Eight General Meeting in New York City on April 27, 1940"; sowie "Report on the Activities of the International Institute of Social Research for the Year 1939". Typoskript, 13 Blatt; "Report to the Trustees of the Kurt Gerlach Memorial Foundation". 23.02.1941, Typoskript mit eigenhändigen Ergänzungen von Max Horkheimer und handschriftlichen Ergänzungen und Korrekturen von Leo Löwenthal, 7 Blatt; Liste der Veröffentlichungen und der Forschungsgebiete des Instituts für Sozialforschung; "Content of Periodicals. List of Articles and Selected Major Book Reviews Arranged According to Contibutors. List of Articles and Selected Major Book Reviews Arranged According Topics. 1934-1941". a) Typoskript, 14 Blatt; b) Typoskript , 15 Blatt; "Literatur über features". 03.02.1941, Veröffentlichungsliste, 1 Blatt; Veröffentlichungsliste zu den Gebieten Nationalsozialismus, Massenkultur, Sozialgeschichte des späteren Mittelalters; 19.12.1941, Typoskript, 1 Blatt; Ankündigung und Übersicht über die ersten Nummern der "Studies in Philosophy and Social Science". 1941; Typoskripte und Drucksachen, 3 Blatt; "Supplementary Memorandum on the Activities of the Institute from 1939 to 1941. (supplemented to December, 1942)". 1942, als Typoskript vervielfältigt, 5 Blatt; Über Organisation und Mitarbeiter des Institutes für Sozialforschung. 1943; a) Typoskript, 6 Blatt; b) Typoskript, 7 Blatt; c) Teilstück, Typoskript mit handschriftlichen Korrekturen, 2 Blatt; d) Teilstück, Typoskript, 3 Blatt; e) Entwurf, Typoskript mit handschriftlichen Korrekturen, 8 Blatt; "Annual Report on the Activities of the Social Studies Association, Inc.". 15.05.1943, Typoskript, 6 Blatt; "Statement of Prof. Dr. Max Horkheimer, Director of the Institut of Social Research on June 9, 1943. Reponse: Certain Charges made against the Institut of Social Research (Columbia University)". 1943; a) Typoskript, 6 Blatt; b) Typoskript mit handschriftlichen Randbemerkungen, 6 Blatt; c) deutsche Rückübersetzung, 1969, Typoskript mit handschriftlichen Korrekturen, 4 Blatt;

Na 1 Nachlass Max Horkheimer, 669 - "Research Project on Anti-Semitism" u.a. (p. IX 121-IX 123)

American Jewish Committee: Meetings of the Advisory Council to Dr. Horkheimer, Sitzungsprotokolle Januar - April 1945, als Typoskripte vervielfältigt, 17 Blatt; Institute of Social Research: "Studies in Antisemitism. A Report on the cooperative project for the study of antisemitism for the year ending March 15, 1944, jointly sponsored by the American Jewish Committee and the Institute of Social Research" (August 1944), a) Typoskript, gebunden, 144 Blatt, b) Typoskript, 144 Blatt; "Report on the Scientific Department of the American Jewish Committee - Dr. Max Horkheimer, Chairman" (January 5, 1945) [1989 von: Hoover Institution, Stanford]: 1. Report, Typoskript (Kopie), 7 Blatt; 2. "Condensed Version of Report for Leidesdorf", Typoskript (Kopie) mit handschriftlichen Korrekturen, 2 Blatt; 3. Memorandum 5.12.1943, Typoskript (Kopie), 1 Blatt; "Meeting of Psychiatrists and Psychoanalysts for Consideration of a Research Project on the Psychology of Antisemitism" Protokoll des Trefffens am 19.4.1945, als Typoskript vervielfältigt, 7 Blatt; "Synopsis of a proposed article on Researches in Antisemitism" (1945): 1. Aufsatz-Entwurd, Typoskript, 8 Blatt, b) Typoskript, 6 Blatt, c) Typoskript, 7 Blatt, d) Typoskript mit handschriftlichen Korrekturen, 7 Blatt, e) Typoskript mit handschriftlichen Korrekturen, 6 Blatt, f) Typoskript mit handschriftlichen Korrekturen und Manuskript, 8 Blatt; 2. L. Sussman: Entwurf, 22.3.1945, Typoskript mit "handschriftlichen Korrekturen, 3 Blatt; 3. "Notes for Dr. Klein re: article in 'Harpers'", Typoskript, 1 Blatt; 4. Harper's Magazine: 1 Brief mit Unterschrift an Max Horkheimer, New York, 8.6.1945, 1 Brief von Max Horkheimer, ohne Ort, 22.5.1945, 2 Blatt;

Na 1 Nachlass Max Horkheimer, 584 - Korrespondenzen mit Friedrich (Frederick) Pollock (p. VI 35, 315-437)

1 Brief von Frederick Pollock an Hans J. Lichtenberger, 06.02.1947; 1 Briefe von Max Horkheimer an das Institute´s Advisory Board 11.01.1947; 1 Brief von Margot von Mendelssohn an Redman Van and Storage Co. (Santa Monica), 07.01.1947; 1 Brief von Gertrud Löwenthal an Redman Van and Storage Co. (Santa Monica), 03.01.1947;

Revising the National Ambient Air Quality Standards: The integration of science and policy

Under the Clean Air Act, Congress granted discretionary decision making authority to the Administrator of the Environmental Protection Agency (EPA). This discretionary authority involves setting standards to protect the public's health with an "adequate margin of safety" based on current scientific knowledge. The Administrator of the EPA is usually not a scientist, and for the National Ambient Air Quality Standard (NAAQS) for particulate matter (PM), the Administrator faced the task of revising a standard when several scientific factors were ambiguous. These factors included: (1) no identifiable threshold below which health effects are not manifested, (2) no biological basis to explain the reported associations between particulate matter and adverse health effects, and (3) no consensus among the members of the Clean Air Scientific Advisory Committee (CASAC) as to what an appropriate PM indicator, averaging period, or value would be for the revised standard. ^ This project recommends and demonstrates a tool, integrated assessment (IA), to aid the Administrator in making a public health policy decision in the face of ambiguous scientific factors. IA is an interdisciplinary approach to decision making that has been used to deal with complex issues involving many uncertainties, particularly climate change analyses. Two IA approaches are presented; a rough set analysis by which the expertise of CASAC members can be better utilized, and a flag model for incorporating the views of stakeholders into the standard setting process. ^ The rough set analysis can describe minimal and maximal conditions about the current science pertaining to PM and health effects. Similarly, a flag model can evaluate agreement or lack of agreement by various stakeholder groups to the proposed standard in the PM review process. ^ The use of these IA tools will enable the Administrator to (1) complete the NAAQS review in a manner that is in closer compliance with the Clean Air Act, (2) expand the input from CASAC, (3) take into consideration the views of the stakeholders, and (4) retain discretionary decision making authority. ^

News media coverage of policies surrounding the HPV vaccine before and after Texas Governor Rick Perry's executive order, February 2006-February 2008

Objective. In June 2006, the first vaccine for human papillomavirus (HPV) was approved by the FDA and shortly after approval, the Advisory Committee on Immunization Practices (ACIP) voted to recommend the HPV vaccine for young girls. As a result of ACIP recommendations, state legislators introduced bills to mandate the vaccine. Policies related to public health issues, such as vaccination mandates, are often influenced by news coverage of these issues. News media, particularly in times of controversies, reinforce specific messages and plays an essential role in framing issues for the public. The objective of this study is to examine the quality, content, and scope of policies for the HPV vaccine before and after Texas Governor Rick Perry issued an executive order mandating the vaccine for middle school girls.^ Methods. The Lexis-Nexis database was used to identify 335 articles on HPV vaccination mandate policies that were published in U.S. newspapers from February 1, 2006 to February 2, 2008. The coding instrument captured information about article type, main news story concern, general information about HPV, HPV vaccine mandate policies, arguments for and against HPV vaccination mandates, arguments for and against the HPV vaccine, and sources of information.^ Results. Most news articles (82.4%) occurred after Governor Rick Perry issued an executive order mandating the HPV vaccine. Most articles mentioned that HPV is sexually transmitted (90.7%) and linked HPV infection to cervical cancer (96.1%). Only 63.9% of the articles reported that the HPV vaccine protects against types of HPV that cause cervical cancer and 18.8% of the articles reported that the vaccine protects against genital warts. Only 18.2% of the news articles presented a balanced argument regarding mandatory HPV vaccinations, and only 39.4% of the news articles presented a balanced argument for the HPV vaccine.^ Conclusions. Our study revealed that news coverage regarding mandating the HPV vaccine and issues related to the vaccine itself is biased, unbalanced, and incomplete. Since the public pays a great deal of attention to health in the media, it is essential that news stories are balanced, complete, and accurate. In order to ensure that future vaccination mandates are not covered in the same way the HPV vaccination was, public health officials, health care providers and scientists should work effectively with the media to ensure that balanced information is provided.^

Mandating the HPV vaccine

Background. HPV is the underlying cause of cervical cancer, a malignant tumor of the female genital tract. Each year, cervical cancer is newly diagnosed in approximately 10,000 women, and over 3,000 women die from the malignancy. In addition, HPV is implicated as a cause of other cancers involving the genital tract, male and female, and the head and neck. ^ Gardasil, a vaccine against HPV, was licensed by the FDA in June 2006. Early study results have shown Gardasil to be safe and effective at preventing HPV infections that are commonly associated with the development of cervical cancer, as well as other HPV-related cancers and genital warts. The vaccine is most effective when administered in childhood, before initial exposure to HPV, which typically occurs shortly after the onset of sexual activity. Accordingly, the CDC's Advisory Committee on Immunization Practices (ACIP) has recommended routine vaccination of females aged 11-12 years. ^ Taking the ACIP recommendation one step further, many states have considered school-based mandates of the HPV vaccine in an attempt to reduce the burden of HPV-related illness, in particular to reduce the disparately high incidence of cervical cancer in medically underserved populations. These mandate attempts have sparked heated debate—highlighting public concerns regarding adolescent sexuality, corporate greed, and vaccines in general. ^ Methods. My research focuses on publicly available sources of information such as medical journals, government reports (federal and state), NGO reports, newspapers, and books. I begin with a background discussion of HPV, cervical cancer, and the HPV vaccine. I then discuss public health policy issues related to vaccines, vaccine mandates, and HPV-related illness. Specifically, I discuss the public health benefit of previous vaccine mandates, the legality of vaccine mandates, and the undue corporate influence on the politics of instituting HPV vaccine mandates. In addition, I examine some of the causes behind the anti-vaccine movement and the controversy surrounding adolescent sexuality as it pertains to the HPV vaccine. In the final section, I focus on the recent failed attempt by Governor Rick Perry to mandate the HPV vaccine in Texas. A retrospective analysis of Governor Perry's policy decisions is undertaken and recommendations are made regarding future attempts to mandate the HPV vaccine, or other vaccines under development for similar sexually transmitted viral diseases such as HIV and herpes simplex. ^ Results. In Texas, as in other states across the country, HPV vaccine mandates faced opposition from those who, while they may support mandates of other vaccines, oppose mandates for the HPV vaccine based largely on the idea that HPV is a sexually transmitted disease—they see responsible sexual behavior as the appropriate method for preventing HPV-related illness. A second major group of opposition comes from those who are generally opposed to all vaccine mandates, due to concerns that mandates are intended primarily for the financial benefit of the pharmaceutical industry or due to concerns—largely unfounded—that vaccines pose a greater health threat than the illnesses they are designed to prevent. ^ Conclusion. In order to reduce opposition to vaccine mandates, care must be taken to educate the public regarding the benefits of vaccination by mobilizing the public health sector, avoid the impression that the decision to institute mandates is rash or pressured by allowing time for open debate, and minimize lobbying efforts by vaccine manufacturers. ^

Process evaluation of the Texas occupational safety & health surveillance system

Introduction: The Texas Occupational Safety & Health Surveillance System (TOSHSS) was created to collect, analyze and interpret occupational injury and illness data in order to decrease the impact of occupational injuries within the state of Texas. This process evaluation was performed midway through the 4-year grant to assess the efficiency and effectiveness of the surveillance system’s planning and implementation activities1. ^ Methods: Two evaluation guidelines published by the Centers for Disease Control and Prevention (CDC) were used as the theoretical models for this process evaluation. The Framework for Program Evaluation in Public Health was used to examine the planning and design of TOSHSS using logic models. The Framework for Evaluating Public Health Surveillance Systems was used to examine the implementation of approximately 60 surveillance activities, including uses of the data obtained from the surveillance system. ^ Results/Discussion: TOSHSS planning activities omitted the creation of a scientific advisory committee and specific activities designed to maintain contacts with stakeholders; and proposed activities should be reassessed and aligned with ongoing performance measurement criteria, including the role of collaborators in helping the surveillance system achieve each proposed activity. TOSHSS implementation activities are substantially meeting expectations and received an overall score of 61% for all activities being performed. TOSHSS is considered a surveillance system that is simple, flexible, acceptable, fairly stable, timely, moderately useful, with good data quality and a PVP of 86%. ^ Conclusions: Through the third year of TOSHSS implementation, the surveillance system is has made a considerable contribution to the collection of occupational injury and illness information within the state of Texas. Implementation of the nine recommendations provided under this process evaluation is expected to increase the overall usefulness of the surveillance system and assist TDSHS in reducing occupational fatalities, injuries, and diseases within the state of Texas. ^ 1 Disclaimer: The Texas Occupational Safety and Health Surveillance System is supported by Grant/Cooperative Agreement Number (U60 OH008473-01A1). The content of the current evaluation are solely the responsibility of the authors and do not necessarily represent the official views of the Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health.^

A review of economic analysis in the vaccination program; decision making and governance: Adivisory Committee on Immunization Practices (ACIP)

The Advisory Committee on Immunization Practices (ACIP) develops written recommendations for the routine administration of vaccines to children and adults in the U.S. civilian population. The ACIP is the only entity in the federal government that makes such recommendations. ACIP elaborates on selection of its members and rules out concerns regarding its integrity, but fails to provide information about the importance of economic analysis in vaccine selection. ACIP recommendations can have large health and economic consequences. Emphasis on economic evaluation in health is a likely response to severe pressures of the federal and state health budget. This study describes the economic aspects considered by the ACIP while sanctioning a vaccine, and reviews the economic evaluations (our economic data) provided for vaccine deliberations. A five year study period from 2004 to 2009 is adopted. Publicly available data from ACIP web database is used. Drummond et al. (2005) checklist serves as a guide to assess the quality of economic evaluations presented. Drummond et al.'s checklist is a comprehensive hence it is unrealistic to expect every ACIP deliberation to meet all of their criteria. For practical purposes we have selected seven criteria that we judge to be significant criteria provided by Drummond et al. Twenty-four data points were obtained in a five year period. Our results show that out of the total twenty-four data point‘s (economic evaluations) only five data points received a score of six; that is six items on the list of seven were met. None of the data points received a perfect score of seven. Seven of the twenty-four data points received a score of five. A minimum of a two score was received by only one of the economic analyses. The type of economic evaluation along with the model criteria and ICER/QALY criteria met at 0.875 (87.5%). These three criteria were met at the highest rate among the seven criteria studied. Our study findings demonstrate that the perspective criteria met at 0.583 (58.3%) followed by source and sensitivity analysis criteria both tied at 0.541 (54.1%). The discount factor was met at 0.250 (25.0%).^ Economic analysis is not a novel concept to the ACIP. It has been practiced and presented at these meetings on a regular basis for more than five years. ACIP‘s stated goal is to utilize good quality epidemiologic, clinical and economic analyses to help policy makers choose among alternatives presented and thus achieve a better informed decision. As seen in our study the economic analyses over the years are inconsistent. The large variability coupled with lack of a standardized format may compromise the utility of the economic information for decision-making. While making recommendations, the ACIP takes into account all available information about a vaccine. Thus it is vital that standardized high quality economic information is provided at the ACIP meetings. Our study may provide a call for the ACIP to further investigate deficiencies within the system and thereby to improve economic evaluation data presented. ^

Process evaluation of intervention program for prevention of early sexual activity and alcohol use among Hispanic teenagers

Hispanic teens are a high-risk population for initiation of early sexual activity and alcohol use which in turn has numerous social and health consequences. One strategy to address prevention of these behaviors is to implement a capacity building intervention that promotes parent child communication, encompasses their cultural values and community participation. This study describes the process evaluation of a pilot intervention program amongst Hispanic teens and their families living along the Texas-Mexico border. “Girls Lets Talk” is a small group intervention with 10-14 year old teens and their female adult family members that involves education regarding effects of alcohol use and sexual activity as well as activities for monitoring and refusal skills to prevent risky behaviors. Two waves of the program each consisting of at least seven mother daughter dyads were conducted. During the designing process, community advisory board meetings and focus groups were held to review course materials and ensure they were appropriate to the Mexican American culture. Parent and adolescent surveys were administered at the beginning and end of the intervention to assess for psychosocial outcome variables. All sessions received high mean satisfactory scores (mean of 4.00 or better on a five point scale) for both adult and adolescent participants. Qualitative feedback was obtained via debriefing sessions to evaluate experience as well as alter recruitment strategies. A Wilcoxon Sign Rank analysis of the pre and post intervention surveys was done that showed significant changes in some outcome variables such as intentions and confidence for monitoring behaviors for adults and beliefs regarding sexual activity. “Girls Lets Talk” is a promising example of how a process evaluation plan can help develop a theory based health promotion program using the community based participatory research approach. The intervention may also be effective in altering intentions and enhancing self-efficacy among parents and teens in order to decrease risky behaviors such as early sexual activity and alcohol use.^

Ethnographic and epidemiologic approaches for the programming of prenatal and birth services in Mesa los Hornos, Mexico

The investigator conducted an action-oriented investigation of pregnancy and birth among the women of Mesa los Hornos, an urban squatter slum in Mexico City. Three aims guided the project: (1) To obtain information for improving prenatal and maternity service utilization; (2) To examine the utility of rapid ethnographic and epidemiologic assessment methodologies; (3) To cultivate community involvement in health development.^ Viewing service utilization as a culturally-bound decision, the study included a qualitative phase to explore women's cognition of pregnancy and birth, their perceived needs during pregnancy, and their criteria of service acceptability. A probability-based community survey delineated parameters of service utilization and pregnancy health events, and probed reasons for decisions to use medical services, lay midwives, or other sources of prenatal and labor and delivery assistance. Qualitative survey of service providers at relevant clinics, hospitals, and practices contributed information on service availability and access, and on coordination among private, social security, and public assistance health service sectors. The ethnographic approach to exploring the rationale for use or non-use of services provided a necessary complement to conventional barrier-based assessment, to inform planning of culturally appropriate interventions.^ Information collection and interpretation was conducted under the aegis of an advisory committee of community residents and service agency representatives; the residents' committee formulated recommendations for action based on findings, and forwarded the mandate to governmental social and urban development offices. Recommendations were designed to inform and develop community participation in health care decision-making.^ Rapid research methods are powerful tools for achieving community-based empowerment toward investigation and resolution of local health problems. But while ethnography works well in synergy with quantitative assessment approaches to strengthen the validity and richness of short-term field work, the author strongly urges caution in application of Rapid Ethnographic Assessments. An ethnographic sensibility is essential to the research enterprise for the development of an active and cooperative community base, the design and use of quantitative instruments, the appropriate use of qualitative techniques, and the interpretation of culturally-oriented information. However, prescribed and standardized Rapid Ethnographic Assessment techniques are counter-productive if used as research short-cuts before locale- and subject-specific cultural understanding is achieved. ^