Thalidomide in Brazil: monitoring with shared responsibility?

This paper discusses issues related to the regulation and rational use of thalidomide in Brazil, by means of a historical approach comprising three different stages. The first part is a historical review of the controversial drug since it was first synthesized, then marketed and subsequently banned during the 1950s and 60s, until the present, when an apparently irreversible process of rehabilitating the drug is under way. Brazilian experience with the use of thalidomide is described, emphasizing legal, political, and institutional work led by two social movements, the Brazilian Association of People with Thalidomide Syndrome (ABPST) and the Movement for Reintegration of People with Hansen's Disease (Morhan). The article describes the results and analyzes an active search of new cases in what is a second generation of thalidomide syndrome in Brazil. Finally, based on clinical and scientific evidence of thalidomide's therapeutic efficacy, the growth of social movements struggling both for and against authorization of the drug, and a restrictive regulation proposed by the Ministry of Health, the article discusses the implementation of policies for the regulation and rational use of thalidomide in Brazil.     

Operationalising ‘sexual orientation’ in routine data collection and equality monitoring in the UK

New legal provisions and regulatory practices in the UK have afforded protection against discrimination for sexual orientation minorities and conferred rights similar to those of heterosexually partnered couples. In addition, sexual orientation has been recognised as one of the main equality strands in new equality legislation and equality governance. Government departments and statutory and other organisations now face the need to collect equal opportunities and other data on these groups to monitor compliance. However, there has been little track record in the UK of collecting data on this dimension, resulting in issues of definition, categorisation, sample size and potential measurement error having to be addressed from a negligible evidence base. Limited survey data indicate significant problems relating to item non‐response and misreporting, reflecting wider concerns about the sensitivity of the data and disclosure. Given that sexual orientation is on track to be mainstreamed in the context of workforce recruitment and service delivery, a strategy across government and other sectors is needed to pool expertise and establish a shared evidence base and stock of good practice.     

How many days of pedometer monitoring predict weekly physical activity in adults?

BACKGROUND: The study purpose was to establish the number (and type) of days needed to estimate mean pedometer-determined steps/day in a field setting. METHODS: Seven days of data were collected from 90 participants (33 males, age = 49.1 +/- 16.2 years, BMI = 27.2 +/- 4.1 kg/m(2); 57 females, age = 44.8 +/- 16.9 years, BMI = 27.0 +/- 5.9 kg/m(2)). Mean steps/day were computed for all 7 days (the criterion), each single day, and combinations of days. Analyses included repeated measures ANOVA, intra-class correlations (ICC), and regression. RESULTS: There was a significant difference (P < 0.001) between days. The difference was limited to Sunday and accounted for 5% of the variance. ICC analyses indicated a minimum of 3 days is necessary to achieve a reliability of 0.80. The adjusted R(2) was 0.79 for a single day (specifically Wednesday), 0.89 for 2 days (Wednesday, Thursday), and 0.94 for 3 days (Wednesday, Thursday, Friday). Sunday was the last day to enter the model. CONCLUSIONS: Although there is a statistical difference between days, there is little practical difference, and the primary distinction appears limited to Sunday. Although a single day of collection is not acceptable, any 3 days can provide a sufficient estimate.     

Long-term monitoring of the mortality trend of Huntington’s disease in Austria

Recent increasing incidence and prevalence rates of Huntingtons disease (HD), a fatal neurodegenerative disorder, prompted us to investigate the epidemiological dynamic of HD in Austria during the period 1970–2001. Our study demonstrated a stable HD mortality rate throughout Austria of 0.125 per 100,000 individuals during the investigated period. The median age at death from HD was 56.5 years for both sexes and remained stable during the entire period observed, indicating no prolonged survival. An above average mortality rate from HD was observed in the north-eastern parts of Austria. Our data reflect the epidemiology of HD prior to and after the availability of genetic testing and provide a solid baseline for future investigations on the epidemiology of HD.This revised was published online in April 2005. In the previous version the article category was missing.     

What is the proper use of hemoglobin A1c monitoring in the elderly?

Diabetes mellitus (DM) is a major health problem for the aging population. Glycemic control is fundamental to the management of diabetes, as glycemic levels are closely linked to development of diabetes-related complications. Measurement of the hemoglobin A1c (A1c) to assess chronic glycemic control is an integral component of diabetes care. Currently, there is no clear evidence that age alters the relationship between A1c and average blood glucose. The Diabetes Control and Complications trial and the United Kingdom Prospective Diabetes Study are the 2 main studies that have provided evidence leading to the widespread recommendation of A1c monitoring. The American Diabetes Association recommends achieving an A1c level of 7% or lower. However, older diabetics represent a heterogeneous population ranging from frail nursing home residents to active community-dwelling elderly with variable life expectancies. One needs to look at the individual in order to best balance risk versus benefit associated with tight glycemic control. Benefits of intensive therapy in an effort to lower A1c must always be weighed against the greater risk of disabling and unpredictable hypoglycemia, as the geriatric population is less likely to benefit from reducing the risk of microvascular complications and more likely to suffer serious adverse effects from hypoglycemia.     

The Global Fund’s paradigm of oversight,monitoring, and results in Mozambique

Background

The Global Fund is one of the largest actors in global health. In 2015 the Global Fund was credited with disbursing close to 10 % of all development assistance for health. In 2011 it began a reform process in response to internal reviews following allegations of recipients’ misuse of funds. Reforms have focused on grant application processes thus far while the core structures and paradigm have remained intact. We report results of discussions with key stakeholders on the Global Fund, its paradigm of oversight, monitoring, and results in Mozambique.

Methods

We conducted 38 semi-structured in-depth interviews in Maputo, Mozambique and members of the Global Fund Board and Secretariat in Switzerland. In-country stakeholders were representatives from Global Fund country structures (eg. Principle Recipient), the Ministry of Health, health or development attachés bilateral and multilateral agencies, consultants, and the NGO coordinating body. Thematic coding revealed concerns about the combination of weak country oversight with stringent and cumbersome requirements for monitoring and evaluation linked to performance-based financing.

Results

Analysis revealed that despite the changes associated with the New Funding Model, respondents in both Maputo and Geneva firmly believe challenges remain in Global Fund’s structure and paradigm. The lack of a country office has many negative downstream effects including reliance on in-country partners and ineffective coordination. Due to weak managerial and absorptive capacity, more oversight is required than is afforded by country team visits. In-country partners provide much needed support for Global Fund recipients, but roles, responsibilities, and accountability must be clearly defined for a successful long-term partnership. Furthermore, decision-makers in Geneva recognize in-country coordination as vital to successful implementation, and partners welcome increased Global Fund engagement.

Conclusions

To date, there are no institutional requirements for formalized coordination, and the Global Fund has no consistent representation in Mozambique’s in-country coordination groups. The Global Fund should adapt grant implementation and monitoring procedures to the specific local realities that would be illuminated by more formalized coordination.

     

A monitoring system for work-related accidents in Piracicaba, São Paulo, Brazil

The authors report on the development of a work accident monitoring system in Piracicaba, S?o Paulo State, Brazil, with the following characteristics: information feeding the system is obtained in real time directly from accident treatment centers; the system has universal monitoring, covering all work-related accidents in Piracicaba, regardless of the nature of the worker's employment conditions, place of work, or place of residence; health surveillance and promotion of health initiatives are triggered by identification of sentinel events; spatial distribution analysis of work-related accidents is a basic tool in designing accident awareness strategies and accident prevention policies. The system was implemented in November 2003 and by October 2004 had identified 5,320 work-related accidents, or a 3.8% annual proportional incidence of work-related accidents in the municipal area. We illustrate spatial analysis of registered work-related accidents and present a detailed investigation of one example of a serious accident.     

Changes in physical activity and heart rate variability in chronic neck–shoulder pain: monitoring during work and leisure time

Objectives

Neck–shoulder pain (NSP) is a common work-related musculoskeletal disorder with unclear mechanisms. Changes in physical activity and autonomic nervous system regulation may be involved in the pathogenesis of chronic NSP. The aim of the current study was to investigate autonomic regulation in relation to physical activity and perceived symptoms during work and leisure time among workers with chronic NSP (n = 29) as compared to a healthy control group (CON, n = 27).

Methods

Physical activity was objectively monitored for 7 days using accelerometry. Beat-to-beat heart rate was collected continuously for 72 h, with simultaneous momentary ratings of pain, stress, and fatigue. Duration of sitting/lying, standing and walking, number of steps, and energy expenditure were used as measures of physical activity. Heart rate variability (HRV) indices were extracted in time and frequency domains as reflecting autonomic regulation. Data were divided into work hours, leisure time, and sleep.

Results

The NSP group rated higher levels of stress and fatigue at work and leisure, and reduced sleep quality as compared to CON. Elevated heart rate and reduced HRV were found in NSP compared with CON, especially during sleep. The NSP group demonstrated a different pattern of physical activity than CON, with a lower activity level in leisure time. Higher physical activity was associated with increased HRV in both groups.

Conclusion

Changes in HRV reflected an autonomic imbalance in workers with chronic musculoskeletal pain. This can be explained by reduced physical activity in leisure time. Intervention studies aimed at increasing physical activity may shed further light on the association between autonomic regulation and physical activity in work-related NSP.     

Microdialysis in the intensive care unit: a novel tool for clinical investigation or monitoring?

Microdialysis is a minimally invasive tool that allows us to gain insight into metabolism at the tissue level. In human investigations, it can be safely performed in the brain (neurosurgical patients), skeletal muscle and adipose tissue. Basically, the technique allows interstitial concentrations of small solutes to be evaluated. Several limitations of the method and possible ways to circumvent them are indicated. Recent technical developments are reviewed. At present, this method is rarely used in metabolic monitoring of critically ill patients, but its potential applications are highlighted.     

Intestinal parasites in children from the Turiec region in long-term monitoring. How should we proceed with further preventive parasitologic examinations?

The results of preventive parasitological examinations for intestinal parasites in preschool and school children of the Turiec Region (Central Slovakia) in 1970-1999 are submitted. The study is divided into three cross-sections in the following decades (1970-1979; 1980-1989; 1990-1999). An acute decrease in geohelminths virtually to zero values has been found, as well as a significant decrease in intestinal protozoans. The occurrence of Enterobius vermicularis, despite its significant decrease in the recent decade, remains on a relatively high level. In the conclusion the authors discuss continuation of parasitological field examinations, and, on the basis of their 30-year experience, they submit their recommendations for the simplest and most effective way of such examinations.     

COVID-19 vaccine reactogenicity – A cohort event monitoring study in the Netherlands using patient reported outcomes

ObjectivesTo explore factors that are associated with reactogenicity in general and systemic after the first dose of COVID-19 vaccine in the Netherlands.DesignA web-based prospective cohort design using patient reported outcomes (PROs).SettingAny person who has been vaccinated with any brand of COVID-19 vaccine in the Dutch COVID immunization programme.Participants22,184 participants. Of these, 13,959 (62.9%) experienced reactogenicity in general and 11,979 (54.0%) systemic reactogenicity within 7 days after vaccination.Main outcome measuresFactors that are associated with the occurrence of reactogenicity after COVID-19 vaccination.ResultsCompared to the Comirnaty® vaccine, the highest odds ratio (OR) for developing reactogenicity was for the Vaxzevria® vaccine (OR 5.18) followed by Spikevax® (OR 2.16), and Janssen (OR 1.65). Participants with a history of COVID-19 disease had a 3.10 increased odds for reactogenicity. Women had a 2.08 increased odds compared to men. Older participants experienced less reactogenicity. Compared to the age group < 50, the ORs for the age groups 50–60, 61–79, and ≥80 were 0.36, 0.15, and 0.10 respectively. The use of an antipyretic drug, or a drug for nervous system disorders gave an increased odds of 1.34 and 1.16 respectively. A body mass index of 25.0–29.9 and over 30 was negatively associated with reactogenicity (OR 0.87 and OR 0.72 respectively). Comorbidities that were associated with reactogenicity were cardiac disorders (OR 1.26), respiratory disorders (OR 1.31), psychiatric disorders (1.37), reproductive disorders (OR 1.54), and eye disorders (OR 1.55). The factors associated with systemic reactogenicity were mostly comparable, but there were differences for comorbidities, drug use, and the strength of the regression coefficient.ConclusionsThis extensive study with over 22,000 vaccine recipients in the Netherlands demonstrated that, taken into account all factors in the model, the Comirnaty® vaccine gave the least and the Vaxzevria® vaccine the most reactogenicity in general and systemic after the first dose. Also a person with a history of COVID-19 disease, female sex and younger age had an increased odds for experiencing reactogenicity after vaccination.     

The role of supportive supervision using mobile technology in monitoring and guiding program performance: a case study in Nigeria, 2015–2016

Background

Supportive supervision is one of the interventions that fosters program improvement by way of imparting knowledge and skills to health workers. The basic challenge in supportive supervision is the availability of data in real time for timely and effective feedback. Thus, the main objective of this study was to determine the contribution of real-time data collection during supportive supervision for timely feedback and generation of evidence for health intervention planning.

Methods

We analyzed supportive supervision records collected through handheld devices employing the open data kit (ODK) platform from July 2015 to June 2016. Supervision was conducted across the country by 592 World Health Organization (WHO) officers. The availability of real-time data and the distance of health facilities to the community were analyzed.

Results

During the study period, 90,396 health facilities were supervised. The average time spent during supervision varied from 1.53 to 3.78 h across the six geopolitical zones of the country. The average interval between completion of the supervisory checklist and synchronization with the server varied from 3.9 h to 7.5 h. The average distance between the health facility and a ward varied from 5 to 24 km.

Conclusion

The use of handheld devices for supportive supervision provided real-time data from health facilities to state and zonal levels for analysis and feedback. Program officers used the findings to rectify process indicators in time for a better outcome.

     

Biological monitoring of workers exposed to 4,4′-methylenediphenyl diisocyanate (MDI) in 19 French polyurethane industries

OBJECTIVES: To study the range of urinary levels of 4,4'-methylenedianiline (MDA), a metabolite of methylenediphenyl diisocyanate (MDI), across factories in the polyurethane industries and to evaluate the validity of this biomarker to assess MDI occupational exposure. METHODS: Workers exposed to MDI, as well as non-occupationally exposed subjects, were studied and pre- and post-shift urine samples were collected from 169 workers of 19 French factories and 120 controls. Details on work activities and practices were collected by a questionnaire and workers were classified into three job categories. The identification and quantification of the total urinary MDA were performed by high-performance liquid chromatography with electrochemical detection (HPLC/EC). RESULTS: For all the factories, MDA was detectable in 73% of the post-shift urine samples. These post-shift values, in the range of <0.10 (detection limit)-23.60 microg/l, were significantly higher than those of the pre-shift samples. Urinary MDA levels in the control group were in the range of < 0.10-0.80 microg/l. The degree of automation of the mixing operation (polyols and MDI) appears as a determinant in the extent of exposure levels. The highest amounts of MDA in urine were found in the spraying or hot processes. The excretion levels of the workers directly exposed to the hardener containing the MDI monomer were significantly higher than those of the other workers. In addition, skin exposure to MDI monomer or to polyurethane resin during the curing step were always associated with significant MDA levels in urine. CONCLUSIONS: Total MDA in post-shift urine samples is a reliable biomarker to assess occupational exposure to MDI in various industrial applications and to help factories to improve their manufacturing processes and working practices. A biological guiding value not exceeding 7 microg/l (5 microg/g creatinine) could be proposed in France.     

How can the UK statutory Cryptosporidium monitoring be used for Quantitative Risk Assessment of Cryptosporidium in drinking water?

Quantitative Microbiological Risk Assessment (QMRA) is increasingly being used to complement traditional verification of drinking water safety through the absence of indicator bacteria. However, the full benefit of QMRA is often not achieved because of a lack of appropriate data on the fate and behaviour of pathogens. In the UK, statutory monitoring for Cryptosporidium has provided a unique dataset of pathogens directly measured in large volumes of treated drinking water. Using this data a QMRA was performed to determine the benefits and limitations of such state-of-the-art monitoring for risk assessment. Estimates of the risk of infection at the 216 assessed treatment sites ranged from 10(-6.5) to 10(-2.5) person(-1) d(-1). In addition, Cryptosporidium monitoring data in source water was collected at eight treatment sites to determine how Cryptosporidium removal could be quantified for QMRA purposes. Cryptosporidium removal varied from 1.8 to 5.2 log units and appeared to be related to source water Cryptosporidium concentration. Application of general removal credits can either over- or underestimate Cryptosporidium removal by full-scale sedimentation and filtration. State-of-the-art pathogen monitoring can identify poorly performing systems, although it is ineffective to verify drinking water safety to the level of 10(-4) infections person(-1) yr(-1).     

Five-year monitoring of a gay-friendly voluntary counselling and testing facility in Switzerland: who got tested and why?

ABSTRACT: BACKGROUND: An increase in new HIV cases among men who have sex with men (MSM) has been reported in Switzerland since 2001. A rapid result HIV testing for MSM through voluntary counselling and testing (VCT) facility ("Checkpoint") was opened in Geneva in 2005. This gay-friendly facility, the first to open in Switzerland, provides testing for sexually transmitted infections (STI) and rapid result HIV testing and counselling. Our objective was to analyze Checkpoint's activity over its first five years of activity and its ability to attract at-risk MSM. METHOD: S We used routine data collected anonymously about the facility activity (number of clients, number of tests, and test results) and about the characteristics of the clientele (sociodemographic data, sexual risk behaviour, and reasons for testing) from 2005 to 2009. RESULTS: The yearly number of HIV tests performed increased from 249 in 2005 to 561 in 2009. The annual proportion of positive tests among tests performed varied between 2% and 3%. Among MSM clients, the median annual number of anal intercourse (AI) partners was three. Roughly 30% of all MSM clients had at least one unprotected anal intercourse (UAI) experience in the previous 12 months with a partner of different/unknown HIV status. The main reason for testing in 2007, 2008, and 2009 was "sexual risk exposure" (~40%), followed by "routine" testing (~30%) and "condom stopping in the beginning of a new steady relationship" (~10%). Clients who came to the facility after a sexual risk exposure, compared to clients who came for other reasons, had the highest number of AI partners in the previous 12 months, were more likely to have had UAI with a partner of different/unknown HIV status in the previous 12 months (57.3%), more likely to have had an STI diagnosed in the past (41.6%), and more likely to report recent feelings of sadness or depression (42.6%). CONCLUSION: Many of Checkpoint's clients reported elevated sexual risk exposure and risk factors, and a noticeable proportion of new HIV cases among MSM living in Geneva were identified by the facility. This VCT facility attracts the intended population and appears to be a useful tool contributing to the fight against the HIV epidemic among MSM in Switzerland.     

A multispecies approach for monitoring persistent toxic substances in the Gulf of Gdańsk (Baltic sea)

Bivalve mussels are usually used for biomonitoring persistent toxic substances (PTS) in coastal ecosystems. Nevertheless, these organisms, which live attached on hard substrates, can be found along the sandy coasts only on human manufactured products. In this work different species collected in the Gulf of Gdańsk were compared to evaluate their suitability for monitoring PTS pollution at a local scale. The clam Mya arenaria seems to represent an excellent indicator of sediment pollution, mainly for organotin compounds which are selectively bioaccumulated. Organochlorine compounds are bioaccumulated in the different species mainly in function of their lipid body burden. Habitat conditions (salinity, substrate, pollution), however, strongly limited the occurrence of different species in the sampling sites; the most ubiquitous species, the common shrimp Crangon crangon, resulted therefore the most suitable to be used for the comparison of PTS pollution in this aquatic environment. Although the blue mussel (Mytilus trossulus) was confirmed to be a very useful sentinel species to compare pollution level inside and outside the Gulf of Gdańsk, we recommend the use of other species to give a more detailed picture of the pollution situation in coastal areas.