Metropolitan and regional health planning: dilemmas of the Pact for Health in the Baixada Santista Metropolitan Area, Sao Paulo State, Brazil

This paper focuses on the relationship between metropolitan and regional health planning based on the processes of regionalization and the Pact for Health in the Baixada Santista Metropolitan Area, Sao Paulo State, Brazil. The method used was a case study in two stages, namely during initial implementation of the Pact for Health (2007) and the Regional Administration Committees (CGR) and in 2010. Municipal and regional health systems managers and the director of the Metropolitan Agency were interviewed, and records were analyzed from ten years of meetings of the Regional Inter-Administration Committee and the Regional Development Council. Four issues emerged: financing and infrastructure; health services utilization; inefficiency of the Regional Health Administration's instruments and decision-making levels; and the relationship between different levels in the Administration. Metropolitan health management remained as an underlying issue, appearing only incidentally or tangentially to regional management. Despite some limitations, the CGR has been legitimized as a space for regional health management.

Photodynamic antimicrobial chemotherapy (PACT) using phenothiazine derivatives as photosensitizers against Leishmania braziliensis

Background and Objective Cutaneous and mucocutaneous leishmaniasis are diseases characterized by skin or mucosal manifestations. In the new world, Leishmania braziliensis is the main etiological agent of cutaneous leishmaniasis, condition that may evolve to the mucocutaneous form. The therapeutic arsenal routinely employed to treat infected patients is unsatisfactory, especially for pentavalent antimonials, treatment recommended by the WHO, as they are often highly toxic, poorly tolerated and of variable effectiveness. This work aimed to evaluate in vitro the effectiveness of photodynamic antimicrobial chemotherapy as a new approach for the treatment of leishmaniasis. Materials and Methods A laser (??=?660?nm, 40?mW, 4.2?J/cm2, and 8.4?J/cm2, CW) associated to phenothiazine's derivatives (5 and 10?mu g/ml, toluidine blue O, methylene blue, or phenothiazine) on the promastigote forms of L. braziliensis in a single session. Samples were removed and analyzed in a hemocytometer 72?hours after PACT and viability of the parasites was assessed in quadruplicates. Results An important decrease in the number of viable parasites on all treated groups in comparison to their controls was observed as all tested compounds lead to significant parasite lethality being the highest lethality achieved with 10?mu g/ml of TBO. No lethality was observed on groups treated with laser or with any of the compounds separately. Conclusions TBO presented higher parasite lethality in comparison to MB with impressive reduction from 1?hour to 5?minutes of pre-incubation time. Lasers Surg. Med. 44: 850855, 2012. (c) 2012 Wiley Periodicals, Inc.

The phenomenological experiences of Autobiographical Memory: A cross-sectional and a longitudinal study

Phenomenology is a critical component of autobiographical memory retrieval. Some memories are vivid and rich in sensory details whereas others are faded; some memories are experienced as emotionally intense whereas others are not. Sutin and Robins (2007) identified 10 dimensions in which a memory may vary—i.e., Vividness, Coherence, Accessibility, Sensory Details, Emotional Intensity, Visual Perspective, Time Perspective, Sharing, Distancing, and Valence—and developed a comprehensive psychometrically sound measure of memory phenomenology, the Memory Experiences Questionnaire (MEQ). Phenomenology has been linked to underlining stable dispositions—i.e. personality, as well as to a variety of positive/negative psychological outcomes—well-being and life satisfaction, depression and anxiety, among others. Using the MEQ, a cross-sectional and a longitudinal study were conducted on a large sample of American and Italian adults. In both studies, participants retrieved two ‘key’ personal memories, a Turning Point and a Childhood Memory, and rated the affect and phenomenology of each memory. Participants also completed self-reported measures of personality (i.e. Neuroticism and Conscientiousness), and measures of depression, well-being and life satisfaction. The present research showed that phenomenological ratings tend (a) to cross-sectionally increase across adulthood (Study 1), and (b) to be moderately stable over time, regardless the contents of the memories (Study 2). Interrelations among memory phenomenology, personality and psychological outcome variables were also examined (Study 1 and Study 2). In particular, autobiographical memory phenomenology was proposed as a dynamic expression of personality functioning that partially explains adaptive/maladaptive psychological outcomes. In fact, the findings partially supported the hypothesized mediating effect of phenomenology on the personality association with psychological outcomes. Implications of the findings are discussed proposing future lines of research. In particular, the need for more longitudinal studies is highlighted, along with the combined application of both self-report questionnaires and narrative measures.

The Failure of Silence and the Manipulation of Memory: How Spain's pact of oblivion has failed to rid the country of its troubled past

This thesis is an analysis of Spain’s development from dictatorship to democracy in light of the trauma that it endured during the Spanish Civil War of 1936 – 1939 and the dictatorship of Francisco Franco, which lasted until 1975. Drawing from the work of Maurice Halbwachs and Pierre Nora, this thesis seeks to use the concepts of collective memory and lieux de mémoire to analyze what role memory has played in Spanish society from 1939 to the present day. Theanalysis begins with an overview of the Spanish Civil War and Franco’s ensuing dictatorship in order to establish an understanding of the trauma endured by Spain and its people. Of importance will be the manner in which the presentation of history became manipulated anddistorted under Franco as the dictator sought to control the country’s collective memory. With this background in mind, the thesis then turns to analyze how the memory of Spain’s past has affected the country’s development in two eras: during its transition to democracy in the 1970s and in the present day. Of central importance is the pact of silence that was established during the transition to democracy, which was a tacit agreement among the Spanish people to notdiscuss the past. This pact of silence still clouds Spain’s memory today and affects modern discourse concerning the past. Yet it is clear that Spain has not been reconciled to its past, as the provocation of history inevitably results in tension and controversy. The central contention of this thesis is that the pact of silence that surrounds Spain’s past has not eliminated the trauma of the Civil War and dictatorship, as demonstrated by the controversy stirred up by people, groups and places in the present day. This contention has repercussions for the study of history as a whole, as it indicates that the past cannot be muted in order to achievereconciliation; rather, it suggests that we must engage the past in order to be reconciled to it.

IN.PACT Amphirion paclitaxel eluting balloon versus standard percutaneous transluminal angioplasty for infrapopliteal revascularization of critical limb ischemia: rationale and protocol for an ongoing randomized controlled trial

BACKGROUND The effectiveness and durability of endovascular revascularization therapies for chronic critical limb ischemia (CLI) are challenged by the extensive burden of infrapopliteal arterial disease and lesion-related characteristics (e.g., severe calcification, chronic total occlusions), which frequently result in poor clinical outcomes. While infrapopliteal vessel patency directly affects pain relief and wound healing, sustained patency and extravascular care both contribute to the ultimate "patient-centric" outcomes of functional limb preservation, mobility and quality of life (QoL). METHODS/DESIGN IN.PACT DEEP is a 2:1 randomized controlled trial designed to assess the efficacy and safety of infrapopliteal arterial revascularization between the IN.PACT Amphirion™ paclitaxel drug-eluting balloon (IA-DEB) and standard balloon angioplasty (PTA) in patients with Rutherford Class 4-5-6 CLI. DISCUSSION This multicenter trial has enrolled 358 patients at 13 European centers with independent angiographic core lab adjudication of the primary efficacy endpoint of target lesion late luminal loss (LLL) and clinically driven target lesion revascularization (TLR) in major amputation-free surviving patients through 12-months. An independent wound core lab will evaluate all ischemic wounds to assess the extent of healing and time to healing at 1, 6, and 12 months. A QoL questionnaire including a pain scale will assess changes from baseline scores through 12 months. A Clinical Events Committee and Data Safety Monitoring Board will adjudicate the composite primary safety endpoints of all-cause death, major amputation, and clinically driven TLR at 6 months and other trial endpoints and supervise patient safety throughout the study. All patients will be followed for 5 years. A literature review is presented of the current status of endovascular treatment of CLI with drug-eluting balloon and standard PTA. The rationale and design of the IN.PACT DEEP Trial are discussed. IN.PACT DEEP is a milestone, prospective, randomized, robust, independent core lab-adjudicated CLI trial that will evaluate the role of a new infrapopliteal revascularization technology, the IA-DEB, compared to PTA. It will assess the overall impact on infrapopliteal artery patency, limb salvage, wound healing, pain control, QoL, and patient mobility. The 1-year results of the adjudicated co-primary and secondary endpoints will be available in 2014. TRIAL REGISTRATION NCT00941733

Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial.

BACKGROUND Drug-eluting balloons (DEB) may reduce infrapopliteal restenosis and reintervention rates versus percutaneous transluminal angioplasty (PTA) and improve wound healing/limb preservation. OBJECTIVES The goal of this clinical trial was to assess the efficacy and safety of IN.PACT Amphirion drug-eluting balloons (IA-DEB) compared to PTA for infrapopliteal arterial revascularization in patients with critical limb ischemia (CLI). METHODS Within a prospective, multicenter, randomized, controlled trial with independent clinical event adjudication and angiographic and wound core laboratories 358 CLI patients were randomized 2:1 to IA-DEB or PTA. The 2 coprimary efficacy endpoints through 12 months were clinically driven target lesion revascularization (CD-TLR) and late lumen loss (LLL). The primary safety endpoint through 6 months was a composite of all-cause mortality, major amputation, and CD-TLR. RESULTS Clinical characteristics were similar between the 2 groups. Significant baseline differences between the IA-DEB and PTA arms included mean lesion length (10.2 cm vs. 12.9 cm; p = 0.002), impaired inflow (40.7% vs. 28.8%; p = 0.035), and previous target limb revascularization (32.2% vs. 21.8%; p = 0.047). Primary efficacy results of IA-DEB versus PTA were CD-TLR of 9.2% versus 13.1% (p = 0.291) and LLL of 0.61 ± 0.78 mm versus 0.62 ± 0.78 mm (p = 0.950). Primary safety endpoints were 17.7% versus 15.8% (p = 0.021) and met the noninferiority hypothesis. A safety signal driven by major amputations through 12 months was observed in the IA-DEB arm versus the PTA arm (8.8% vs. 3.6%; p = 0.080). CONCLUSIONS In patients with CLI, IA-DEB had comparable efficacy to PTA. While primary safety was met, there was a trend towards an increased major amputation rate through 12 months compared to PTA. (Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia [INPACT-DEEP]; NCT00941733).

An analysis of IN.PACT DEEP randomized trial on the limitations of the societal guidelines-recommended hemodynamic parameters to diagnose critical limb ischemia.

OBJECTIVE Recent small single-center data indicate that the current hemodynamic parameters used to diagnose critical limb ischemia are insensitive. We investigated the validity of the societal guidelines-recommended hemodynamic parameters against core laboratory-adjudicated angiographic data from the multicenter IN.PACT DEEP (RandomIzed AmPhirion DEEP DEB vs StAndard PTA for the treatment of below the knee Critical limb ischemia) Trial. METHODS Of the 358 patients in the IN.PACT DEEP Trial to assess drug-eluting balloon vs standard balloon angioplasty for infrapopliteal disease, 237 had isolated infrapopliteal disease with an available ankle-brachial index (ABI), and only 40 of the latter had available toe pressure measurements. The associations between ABI, ankle pressure, and toe pressure with tibial runoff, Rutherford category, and plantar arch were examined according to the cutoff points recommended by the societal guidelines. Abnormal tibial runoff was defined as severely stenotic (≥70%) or occluded and scored as one-, two-, or three-vessel disease. A stenotic or occluded plantar arch was considered abnormal. RESULTS Only 14 of 237 patients (6%) had an ABI <0.4. Abnormal ankle pressure, defined as <50 mm Hg if Rutherford category 4 and <70 mm Hg if Rutherford category 5 or 6, was found only in 37 patients (16%). Abnormal toe pressure, defined as <30 mm Hg if Rutherford category 4 and <50 mm Hg if Rutherford category 5 or 6, was found in 24 of 40 patients (60%) with available measurements. Importantly, 29% of these 24 patients had an ABI within normal reference ranges. A univariate multinomial logistic regression found no association between the above hemodynamic parameters and the number of diseased infrapopliteal vessels. However, there was a significant paradoxic association where patients with Rutherford category 6 had higher ABI and ankle pressure than those with Rutherford category 5. Similarly, there was no association between ABI and pedal arch patency. CONCLUSIONS The current recommended hemodynamic parameters fail to identify a significant portion of patients with lower extremity ulcers and angiographically proven severe disease. Toe pressure has better sensitivity and should be considered in all patients with critical limb ischemia.