The genesis of the PM-JAY health insurance scheme in India: technical and political elements influencing a national reform towards universal health coverage.

Many countries are using health insurance to advance progress towards universal health coverage (UHC). India launched the Pradhan Mantri Jan Arogya Yojana (PM-JAY) health insurance scheme in 2018. We examine the political economy context around PM-JAY policy formulation, by examining the perspectives of policy stakeholders shaping decisions around the reform. More specifically, we focus on early policy design at the central (national) level. We use a framework on the politics of UHC reform proposed by Fox and Reich (The politics of universal health coverage in low- and middle-income countries: A framework for evaluation and action. J. Health Polit. Policy Law 2015;40:1023-1060), to categorize the reform into phases and examine the interactions between actors, institutions, interests, ideas and ideology which shaped reform decisions. We interviewed 15 respondents in Delhi between February and April 2019, who were either closely associated with the reform process or subject experts. The ruling centre-right government introduced PM-JAY shortly before national elections, drawing upon policy legacies from prior and state insurance schemes. Empowered policy entrepreneurs within the government focused discourse around ideas of UHC and strategic purchasing, and engaged in institution building leading to the creation of the National Health Authority and State Health Agencies through policy directives, thereby expanding state infrastructural and institutional power for insurance implementation. Indian state inputs were incorporated in scheme design features like mode of implementation, benefit package and provider network, while features like the coverage amount, portability of benefits and branding strategy were more centrally driven. These balanced negotiations opened up political space for a cohesive, central narrative of the reform and facilitated adoption. Our analysis shows that the PM-JAY reform focused on bureaucratic rather than ideological elements and that technical compromises and adjustments accommodating the interests of states enabled the political success of policy formulation. Appreciating these politics, power and structural issues shaping PM-JAY institutional design will be important to understand how PM-JAY is implemented and how it advances UHC in India.

Knowledge of COVID-19 and the impact on indigents' access to healthcare in Burkina Faso.

BACKGROUND: COVID-19 constitutes a global health emergency of unprecedented proportions. Preventive measures, however, have run up against certain difficulties in low and middle-income countries. This is the case in socially and geographically marginalized communities, which are excluded from information about preventive measures. This study contains a dual objective, i) to assess knowledge of COVID-19 and the preventive measures associated with it concerning indigents in the villages of Diebougou's district in Burkina Faso. The aim is to understand if determinants of this understanding exist, and ii) to describe how their pathways to healthcare changed from 2019 to 2020 during the COVID-19 pandemic. METHODS: The study was conducted in the Diebougou healthcare district, in the south-west region of Burkina Faso. We relied on a cross-sectional design and used data from the fourth round of a panel survey conducted among a sample of ultra-poor people that had been monitored since 2015. Data were collected in August 2020 and included a total of 259 ultra-poor people. A multivariate logistic regression to determine the factors associated with the respondents' knowledge of COVID-19 was used. RESULTS: Half of indigents in the district said they had heard about COVID-19. Only 29% knew what the symptoms of the disease were. The majority claimed that they protected themselves from the virus by using preventive measures. This level of knowledge of the disease can be observed with no differences between the villages. Half of the indigents who expressed themselves agreed with government measures except for the closure of markets. An increase of over 11% can be seen in indigents without the opportunity for getting healthcare compared with before the pandemic. CONCLUSIONS: This research indicates that COVID-19 is partially known and that prevention measures are not universally understood. The study contributes to reducing the fragmentation of knowledge, in particular on vulnerable and marginalized populations. Results should be useful for future interventions for the control of epidemics that aim to leave no one behind.

How far is mixed methods research in the field of health policy and systems in Africa? A scoping review.

Both the academic and the policy community are calling for wider application of mixed methods research, suggesting that combined use of quantitative and qualitative methods is most suitable to assess and understand the complexities of health interventions. In spite of recent growth in mixed methods studies, limited efforts have been directed towards appraising and synthetizing to what extent and how mixed methods have been applied specifically to Health Policy and Systems Research (HPSR) in low- and middle-income countries (LMICs). We aimed at filling this gap in knowledge, by exploring the scope and quality of mixed methods research in the African context. We conducted a scoping review applying the framework developed by Arksey and O'Malley and modified by Levac et al. to identify and extract data from relevant studies published between 1950 and 2013. We limited our search to peer-reviewed HPSR publications in English, which combined at least one qualitative and one quantitative method and focused on Africa. Among the 105 studies that were retained for data extraction, over 60% were published after 2010. Nearly 50% of all studies addressed topics relevant to Health Systems, while Health Policy and Health Outcomes studies accounted respectively for 40% and 10% of all publications. The quality of the application of mixed methods varied greatly across studies, with a relatively small proportion of studies stating clearly defined research questions and differentiating quantitative and qualitative elements, including sample sizes and analytical approaches. The methodological weaknesses observed could be linked to the paucity of specific training opportunities available to people interested in applying mixed methods to HPSR in LMICs as well as to the limitations on word limit, scope and peer-review processes at the journals levels. Increasing training opportunities and enhancing journal flexibility may result in more and better quality mixed methods publications.

A "novel" association to treat pain: tramadol/dexketoprofen. The first drug of a "new pharmacological class".

Acute and chronic pain have an important socio-economical impact. In order to help physicians to choose the appropriate drug, especially for cancer pain, in 1986 WHO has developed a three-step analgesic "ladder" for cancer pain relief in adults. Later it has also been used for acute pain and chronic non-cancer pain. In step I nonsteroidal anti-inflammatory drugs (NSAIDs) are considered with or without adjuvants, in step II the use of weak opioids for mild-moderate pain, with or without NSAIDs and adjuvant, is suggested, while the step III is reserved to strong opioids for moderate-severe pain with or without non-opioids or adjuvants. In the last two decades, a better pathophysiology knowledge has improved pain management shifting our view from the pain ladder to a modern pain pyramid, in which drugs are selected not only on the basis of pain intensity, but mainly according to mechanisms underlying pain, including peripheral and spinal sensitization which is the main trigger of chronic pain. The best pharmacological approach has become multimodal, in which drugs belonging to different steps should be combined, matching the mechanisms of action with the type of pain. An important corollary of combining analgesic drugs with different mechanism of action is that proper matching achieves the same effect with lower doses, better outcome and fewer adverse effects. In this new perspective, fixed-dose pharmaceutical combinations of different drugs are very useful to fulfil pharmacodynamics, pharmacokinetics and adherence criteria, enriching the pain pyramid of half-steps between the first and second step and between the second and third step. Hence, a new fixed combination of a NSAID with peripheral and central anti-infilammatory activities, such as dexketoprofen, and a weak opioid, such as tramadol, with double analgesic activity in the spinal cord as an opioid and, at the same time, on the descending modulatory pathways, is expected to cover a wide range of acute and recurrent painful conditions, ranging from nociceptive inflammatory pain to neuropathic pain of moderate/severe intensity. In this review we evaluate the rationale that justifies its use as new class of pharmacological modality to treat pain accordingly also to a more update view of WHO pain ladder.

The prevention of analgesic opioids abuse: expert opinion.

Opioids are drugs of reference for the treatment of moderate to severe pain. Their proper use and a periodic assessment of the patient are crucial to prevent misuse. A multidisciplinary group suggests strategies for all stakeholders involved in the management of pain and suggests the importance of the doctor-patient relationship.

OPRM1 receptor as new biomarker to help the prediction of post mastectomy pain and recurrence in breast cancer.

Breast cancer is the most common type of cancer among women worldwide. Short-term postsurgical recovery is complicated by many factors, including imbalanced inflammatory and immune response, acute pain associated with functional impairment, and chronic postmastectomy pain (CPMP), developed by about 25-60% of patients. Opioids, most common drugs used for treatment of cancer pain, are immunosuppressive, and therefore, they might directly and/or indirectly influence long-term cancer recurrence. Moreover, they also produce endocrinopathy, which consists primarily of hypothalamic-pituitary-gonadal axis or hypothalamic-pituitary-adrenal axis dysfunction. The interindividual variability in both CPMP and opioid response is believed to be largely underlined by genetic variability in the gene locus for µ-opioid receptor (OPRM1) that modulates opioid pharmacodynamics. For this reason, OPRM1 genotype may play a key role both in short-term postmastectomy outcome and in long-term follow-up, becoming a new biomarker for breast cancer recurrence in patients suffering from chronic postmastectomy pain managed by opioid therapy. Hence OPRM1 might be used in near future to customize the opioid therapy, avoiding not only opioid side effects but also the disease progression. In this review we evaluate the literature state of the art on this topic and possible steps towards obtaining the safest individualized postmastectomy analgesic therapy. Therefore, a personalized pain treatment strategy might be useful to both manage pain and control cancer disease progression.

The impact of user fee removal policies on household out-of-pocket spending: evidence against the inverse equity hypothesis from a population based study in Burkina Faso.

BACKGROUND: User fee removal policies have been extensively evaluated in relation to their impact on access to care, but rarely, and mostly poorly, in relation to their impact on household out-of-pocket (OOP) spending. This paucity of evidence is surprising given that reduction in household economic burden is an explicit aim for such policies. Our study assessed the equity impact on household OOP spending for facility-based delivery of the user fee reduction policy implemented in Burkina Faso since 2007 (i.e., subsidised price set at 900 Communauté Financière Africaine francs (CFA) for all, but free for the poorest). Taking into account the challenges linked to implementing exemption policies, we aimed to test the hypothesis that the user fee reduction policy had favoured the least poor more than the poor. METHODS: We used data from six consecutive rounds (2006-2011) of a household survey conducted in the Nouna Health District. Primary outcomes are the proportion of households being fully exempted (the poorest 20% according to the policy) and the actual level of household OOP spending on facility-based delivery. The estimation of the effects relied on a Heckman selection model. This allowed us to estimate changes in OOP spending across socio-economic strata given changes in service utilisation produced by the policy. FINDINGS: A total of 2,316 women reported a delivery between 2006 and 2011. Average household OOP spending decreased from 3,827 CFA in 2006 to 1,523 in 2011, without significant differences across socio-economic strata, neither in terms of households being fully exempted from payment nor in terms of the amount paid. Payment remained regressive and substantially higher than the stipulated 900 CFA. CONCLUSIONS: The Burkinabè policy led to a significant and sustained reduction in household OOP health spending across all socio-economic groups, but failed to properly target the poorest by ensuring a progressive payment system.

A year in review in Minerva Anestesiologica 2013.

BACKGROUND: We organized a training program for oral fiber optic intubation (FOI) under conscious sedation. The efficacy of the program was evaluated by comparing the performances of experts and novices. METHODS: The training procedure was divided into two sessions: a theoretical session on difficult airways, the fiber optic bronchoscope (FOB), remifentanil, topical anesthesia and patient interactions; and a session involving simulations of the FOI technique on dummies. For in vivo FOI, we enrolled patients requiring orotracheal intubation for elective surgery. Electrocardiograms, mean arterial pressure was railroaded over the fiberscope, and tracheal intubati6 and 7) FOIs, respectively, joined the study. To reach ±23 bpm, P=0.02), and RR was decreased (from 16±3 to 12±4 bpm, P<0.05). No differences were recorded between the experts and less-experienced anesthesiologists. The average duration of FOI was 3.3±2.0 min for experts and 4.2±2.4 min for novices (P=0.03). Procedures were successful in both groups, with patients in each group being equally satisfied with the procedures. CONCLUSION: This study highlights the importance of a structured FOI training program, demonstrating that it is possible to learn to perform FOI proficiently by practicing on dummies.

Chronic pain management in pregnancy and lactation.

During pregnancy most of women will experience some kind of pain, either as a result of a pre-existing condition (low back pain, headache, fibromyalgia, and rheumatoid arthritis) or as a direct consequence of pregnancy (weight gain, postural changes, pelvic floor dysfunction, hormonal factors). However, chronic pain management during pregnancy and lactation remains a challenge for clinicians and pregnant women are at risk of undertreatment for painful conditions, because of fear about use of drugs during pregnancy. Few analgesic drugs have been demonstrated to be absolutely contraindicated during pregnancy and breastfeeding, but studies in pregnant women are not available for most of pain medications. The aim of this paper is to review the safety profile in pregnancy or lactation of the commonly prescribed pain medications and non-pharmacological treatments. In addition to the conventional classifications from the Food and Drug Administration and the American Academy of Paediatrics, authors analyzed the currently available clinical data from literature.

How do the EMA and FDA decide which anticancer drugs make it to the market? A comparative qualitative study on decision makers' views.

BACKGROUND: The process leading to a regulatory outcome is guided by factors both related and unrelated to the data package, defined in this analysis as 'formal and informal factors', respectively. The aim of this qualitative study was to analyse which formal and informal factors drive the decision-making process of the European Medicines Agency (EMA) and Food and Drug Administration (FDA) regulators with regard to anticancer drugs, using in-depth semi-structured interviews with regulators of the two agencies. METHODS: In line with the theory and practice of qualitative research, no set sample size was defined a priori. Respondent enrolment continued until saturation and redundancy were reached. Data were collected through means of in-depth semi-structured interviews conducted either in a face-to-face setting or via Skype(®) with each regulator. The interviews were audio-recorded and verbatim transcribed. The analysis was manually carried out on the transcribed text. Data were independently coded and categorized by two researchers. Interpretation of the findings emerged through a process of triangulation between the two. RESULTS: Seven EMA and six FDA regulators, who had extensive experience with making decisions about anticancer medicines, were interviewed between April and June 2012. There is an open dialogue between the FDA and EMA, with the two moving closer and exchanging information, not opinions. Differences in decision-making between the agencies may be due to a different evaluation of end points. Different interaction modalities with industry and patients represent an additional source of divergence with a potential impact on decision-making. The key message of our respondents was that the agencies manage uncertainty in a different way: unlike the EMA, the FDA has a prevailing attitude to take risks in order to guarantee quicker access to new treatments. CONCLUSIONS: Although formal factors are the main drivers for regulatory decisions, the influence of informal factors plays an important role in the drug evaluation process.

Valproic acid induces the glutamate transporter excitatory amino acid transporter-3 in human oligodendroglioma cells.

Glutamate transport in early, undifferentiated oligodendrocytic precursors has not been characterized thus far. Here we show that human oligodendroglioma Hs683 cells are not endowed with EAAT-dependent anionic amino acid transport. However, in these cells, but not in U373 human glioblastoma cells, valproic acid (VPA), an inhibitor of histone deacetylases, markedly induces SLC1A1 mRNA, which encodes for the glutamate transporter EAAT3. The effect is detectable after 8h and persists up to 120h of treatment. EAAT3 protein increase becomes detectable after 24h of treatment and reaches its maximum after 72-96h, when it is eightfold more abundant than control. The initial influx of d-aspartate increases in parallel, exhibiting the typical features of an EAAT3-mediated process. SLC1A1 mRNA induction is associated with the increased expression of PDGFRA mRNA (+150%), a marker of early oligodendrocyte precursor cells, while the expression of GFAP, CNP and TUBB3 remains unchanged. Short term experiments have indicated that the VPA effect is shared by trichostatin A, another inhibitor of histone deacetylases. On the contrary, EAAT3 induction is neither prevented by inhibitors of mitogen-activated protein kinases nor triggered by a prolonged incubation with lithium, thus excluding a role for the GSK3ß/ß-catenin pathway. Thus, the VPA-dependent induction of the glutamate transporter EAAT3 in human oligodendroglioma cells likely occurs through an epigenetic mechanism and may represent an early indicator of commitment to oligodendrocytic differentiation.

Acute and chronic pain: where we are and where we have to go.

In recent years, increasing attention has been focused on the treatment of acute and chronic pain with a considerable number of publications about it. Nevertheless all the attention focused on it, the evidence of pain treatments is still unfolding, and occasionally conflicting. Hence it is still necessary that we point out our research efforts in trying to obtain a better understand of pathophysiology of pain and of real efficacy and safety of acute and chronic pain treatments. Our goal with this review is to summarize the latest research trends and the most advanced therapeutic standards for pain syndromes described in the literature, the discussion will be divided in four main topics, as these topics were treated during the SIMPAR (Study In Multidisciplinary PAin Research) meeting, held on December 2010 in Pavia: pathophysiology of pain, acute postoperative pain, opioids and pain, and chronic pain (Failed Back Surgery Syndrome). In the chapter of pathophysiology of pain we analyzed how to obtain a more personalized treatment through the study of the genetic and neurophysiological characteristics of patients and how to select the right local anesthetic according to anatomic and metabolizing patterns of patients. In acute postoperative pain we focalized our attention on the evidence supporting the use of continuous peripheral nerve blocks in the treatment of postoperative pain and in the prevention of chronic persistent post-operative pain, with a special attention in preventing side effects of regional anesthesia. We also reviewed the current evidence about the use of new very interesting modality to control postoperative pain after laparoscopy: pre-emptive nebulization of local anesthetic in abdominal cavity. As opioids are currently widely used to control chronic oncologic and non-oncologic pain, in this review we analyzed the level of evidence for their use, how to manage them better and psychological factors that can affect their success and/or determine addiction. Finally, we summarized the current evidence about Failed Back Surgery Syndrome focalizing our attention both in diagnosing it correctly and treating this syndrome with specific knowledge of the anatomic space that we have to approach and applying the possible treatments depending on pain pathophysiology and patient characteristics. In conclusion, it is important to try to personalize even better the therapy of patients with acute and chronic pain through a more accurate knowledge of anatomy, pathophysiology of pain, pharmacokinetic of pain drugs and of new device/therapies available.