Facilitating and motivating factors for reporting reprehensible conduct in care: A study among nurse practitioners and physician assistants in the Netherlands

Rationale, aims and objectives The aims of this study are as follows: (a) to establish whether a relationship exists between the importance that healthcare professionals attach to ethics in care and their likelihood to report reprehensible conduct committed by colleagues, and (b) to assess whether this relationship is moderated by behavioural control targeted at preventing harm. Method In this cross-sectional study, which was based on a convenience sample (n = 155) of nurse practitioners (NPs) and physician assistants (PAs) in the Netherlands, we measured ethics advocacy (EA) as a motivating factor (reflecting the importance that healthcare professionals attach to ethics and care) and "behavioral control targeted at preventing harm" (BCPH) as a facilitating factor. "Reporting reprehensible conduct" (RRC) was measured as a context-specific indicator of whistleblowing intentions, consisting of two vignettes describing morally questionable behaviour committed by colleagues. Results The propensity to report reprehensible conduct was a function of the interaction between EA and BCPH. The only group for which EA predicted RRC consisted of individuals with above-average levels of perceived BCPH. Conclusion The results suggest that the importance that healthcare professionals attach to ethical aspects in care is not sufficient to ensure that they will report reprehensible conduct. Such importance does not induce reporting behaviour unless the professionals also perceive themselves as having a high level of BCPH. We suggest that these insights could be helpful in training healthcare providers to cope with ethical dilemmas that they are likely to encounter in their work

Talking to the people that really matter about their participation in pandemic clinical research: a qualitative study in four European countries

Background Pandemics of new and emerging infectious diseases are unpredictable, recurrent events that rapidly threaten global health and security. We aimed to identify public views regarding provision of information and consent to participate in primary and critical care clinical research during a future influenza-like illness pandemic. Methods Descriptive-interpretive qualitative study, using focus groups (n = 10) and semi-structured interviews (n = 16), with 80 members of the public (>18 years) in Belgium, Spain, Poland and the UK. Local qualitative researchers followed a scenario-based topic guide to collect data. Data were transcribed verbatim, translated into English and subject to framework analysis. Results Public understandings of pandemics were shaped by personal factors (illness during the previous H1N1 pandemic, experience of life-threatening illness) and social factors (historical references, media, public health information). Informants appreciated safeguards provided by ethically robust research procedures, but current enrolment procedures were seen as a barrier. They proposed simplified enrolment processes for higher risk research and consent waiver for certain types of low-risk research. Decision making about research participation was influenced by contextual, research and personal factors. Informants generally either carefully weighed up various approaches to research participation or responded instinctively. They supported the principle of using routinely collected, anonymized clinical biological samples for research without explicit consent, but regarded this as less acceptable if researchers were motivated primarily by commercial gain. Conclusions This bottom-up approach to ascertaining public views on pandemic clinical research has identified support for more proportionate research protection procedures for publically funded, low-risk studies

Design and objectives of the South American youth/child cardiovascular and environmental (SAYCARE) Study

ABSTRACT: The purpose of this paper is to introduce the overarching study design of the South American Youth/Child Cardiovascular and Environmental (SAYCARE) study, which is an observational multicenter feasibility study held in seven South American cities: Buenos Aires (Argentina), Lima (Peru), Medellin (Colombia), Montevideo (Uruguay), Santiago (Chile), and Sao Paulo and Teresina (Brazil). Children and ~ adolescents (3-17 years of age) were studied. Methods: The data management systems, quality assurance monitoring activities, standardized operating procedure manuals, and training and study management are addressed in this paper. Various quality controls to ensure the collection of valid and reliable data are also discussed. Results and Conclusions: Data were obtained from 237 preschoolers and schoolchildren and 258 adolescents during the validation phase measurements. The results of the SAYCARE study are expected to provide higher accuracy in the assessment of cardiovascular disease risk factors, including eating behaviors, body composition, physical activity, sedentary behaviors, lipid profiles and cardiovascular health biomarkers, oral health, social conditions, environmental factors and home environment, and their determinants in children and adolescents from ages 3 to 17 in seven South American cities

Breast-milk iodine concentration declines over the first 6 mo postpartum in iodine-deficient women.

BACKGROUND: Little is known about the iodine status of lactating mothers and their infants during the first 6 mo postpartum or, if deficient, the amount of supplemental iodine required to improve status. OBJECTIVE: The objective was to determine maternal and infant iodine status and the breast-milk iodine concentration (BMIC) over the first 6 mo of breastfeeding. DESIGN: A randomized, double-blind, placebo-controlled supplementation trial was conducted in lactating women who received placebo (n = 56), 75 μg I/d (n = 27), or 150 μg I/d (n = 26) after their infants' birth until 24 wk postpartum. Maternal and infant urine samples and breast-milk samples were collected at 1, 2, 4, 8, 12, 16, 20, and 24 wk. Maternal serum thyrotropin and free thyroxine concentrations were measured at 24 wk. RESULTS: Over 24 wk, the median urinary iodine concentration (UIC) of unsupplemented women and their infants ranged from 20 to 41 μg/L and 34 to 49 μg/L, respectively, which indicated iodine deficiency (ie, UIC < 100 μg/L). Mean maternal UIC was 2.1-2.4 times higher in supplemented than in unsupplemented women (P < 0.001) but did not differ significantly between the 2 supplemented groups. BMIC in the placebo group decreased by 40% over 24 wk (P < 0.001) and was 1.3 times and 1.7 times higher in women supplemented with 75 μg I/d (P = 0.030) and 150 μg I/d (P < 0.001), respectively, than in unsupplemented women. Thyrotropin and free thyroxine did not differ significantly between groups. CONCLUSION: BMIC decreased in the first 6 mo in these iodine-deficient lactating women; supplementation with 75 or 150 μg I/d increased the BMIC but was insufficient to ensure adequate iodine status in women or their infants. The study was registered with the Australian New Zealand Clinical Trials Registry as ACTRN12605000345684

Reducing the environmental impact of trials: a comparison of the carbon footprint of the CRASH-1 and CRASH-2 clinical trials

BACKGROUND: All sectors of the economy, including the health research sector, must reduce their carbon emissions. The UK National Institute for Health Research has recently prepared guidelines on how to minimize the carbon footprint of research. We compare the carbon emissions from two international clinical trials in order to identify where emissions reductions can be made. METHODS: We conducted a carbon audit of two clinical trials (the CRASH-1 and CRASH-2 trials), quantifying the carbon dioxide emissions produced over a one-year audit period. Carbon emissions arising from the coordination centre, freight delivery, trial-related travel and commuting were calculated and compared. RESULTS: The total emissions in carbon dioxide equivalents during the one-year audit period were 181.3 tonnes for CRASH-1 and 108.2 tonnes for CRASH-2. In total, CRASH-1 emitted 924.6 tonnes of carbon dioxide equivalents compared with 508.5 tonnes for CRASH-2. The CRASH-1 trial recruited 10,008 patients over 5.1 years, corresponding to 92 kg of carbon dioxide per randomized patient. The CRASH-2 trial recruited 20,211 patients over 4.7 years, corresponding to 25 kg of carbon dioxide per randomized patient. The largest contributor to emissions in CRASH-1 was freight delivery of trial materials (86.0 tonnes, 48% of total emissions), whereas the largest contributor in CRASH-2 was energy use by the trial coordination centre (54.6 tonnes, 30% of total emissions). CONCLUSIONS: Faster patient recruitment in the CRASH-2 trial largely accounted for its greatly increased carbon efficiency in terms of emissions per randomized patient. Lighter trial materials and web-based data entry also contributed to the overall lower carbon emissions in CRASH-2 as compared to CRASH-1. TRIAL REGISTRATION NUMBERS: CRASH-1: ISRCTN74459797CRASH-2: ISRCTN86750102

Early targeted brain COOLing in the cardiac CATHeterisation laboratory following cardiac arrest (COOLCATH)

Introduction: Trials demonstrate significant clinical benefit in patients receiving therapeutic hypothermia (TH) after cardiac arrest. However, incidence of mortality and morbidity remains high in this patient group. Rapid targeted brain hypothermia induction, together with prompt correction of the underlying cause may improve outcomes in these patients. This study investigates the efficacy of Rhinochill®, an intranasal cooling device over Blanketrol®, a surface cooling device in inducing TH in cardiac arrest patients within the cardiac catheter laboratory. Methods: 70 patients were randomized to TH induction with either Rhinochill® or Blanketrol®. Primary outcome measures were time to reach tympanic ≤34 °C from randomisation as a surrogate for brain temperature and oesophageal ≤34 °C from randomisation as a measurement of core body temperature. Secondary outcomes included first hour temperature drop, length of stay in intensive care unit, hospital stay, neurological recovery and all-cause mortality at hospital discharge. Results: There was no difference in time to reach ≤34 °C between Rhinochill® and Blanketrol® (Tympanic ≤34 °C, 75 vs. 107 mins; p = 0.101; Oesophageal ≤34 °C, 85 vs. 115 mins; p = 0.151). Tympanic temperature dropped significantly with Rhinochill® in the first hour (1.75 vs. 0.94 °C; p < 0.001). No difference was detected in any other secondary outcome measures. Catheter laboratory-based TH induction resulted in a survival to hospital discharge of 67.1%. Conclusion: In this study, Rhinochill® was not found to be more efficient than Blanketrol® for TH induction, although there was a non-significant trend in favour of Rhinochill® that potentially warrants further investigation with a larger trial

Issues of informed consent for intrapartum trials: a suggested consent pathway from the experience of the Release trial [ISRCTN13204258]

Service users within the NHS are increasingly being asked to participate in clinical research. In Liverpool Women's NHS Foundation Trust, approximately 35% of women take part in research during their pregnancy. For many studies the consent process is simple; information is provided and signed consent is given. There is a difficulty, however, with obtaining informed consent from women in pregnancy who become eligible only when they develop unforeseen complications, especially when they occur acutely. The problem is compounded with women in labour who may be frightened, vulnerable, in pain, under the effect of opiate analgesia, or all of the above. If research to improve the care of these women is to continue, then special consent procedures are needed. These procedures must ensure that the woman's autonomy is protected whilst recognising that women under these circumstances vary enormously, both in their desire for information and their ability to comprehend it. This paper will discuss the obtaining of consent in this situation, and describe an information and consent pathway for intrapartum research which has been developed in collaboration with consumer groups as a way in which these issues can be tackled

Consumers as tutors – legitimate teachers?

BACKGROUND: The aim of this study was to research the feasibility of training mental health consumers as tutors for 4(th )year medical students in psychiatry. METHODS: A partnership between a consumer network and an academic unit in Psychological Medicine was formed to jointly develop a training package for consumer tutors and a curriculum in interviewing skills for medical students. Student attitudes to mental health consumers were measured pre and post the program. All tutorial evaluation data was analysed using univariate statistics. Both tutors and students evaluated the teaching program using a 4 point rating scale. The mean scores for teaching and content for both students and tutors were compared using an independent samples t-test. RESULTS: Consumer tutors were successfully trained and accredited as tutors and able to sustain delivery of tutorials over a 4 year period. The study found that whilst the medical students started with positive attitudes towards consumers prior to the program, there was a general trend towards improved attitude across all measures. Other outcomes for tutors and students (both positive and negative) are described. CONCLUSIONS: Consumer tutors along with professional tutors have a place in the education of medical students, are an untapped resource and deliver largely positive outcomes for students and themselves. Further possible developments are described

Recent physician strike in Israel: a health system under stress?

In 2011, a series of physician strikes in Israel followed eight months of unsuccessful negotiations with the government (Ministry of Health and the Ministry of Finance). Strikes by physicians may be a warning that all is not well in a health system and protestors have claimed that they signify a system failure. In contrast, others argue that strikes have been a feature of the Israeli health system from its inception and should not be a cause for alarm. This paper analyses the Israeli health system from the perspective of the strikers' demands using the World Health Organisation's six health system building blocks as a framework, including: service delivery; health workforce; information; medical products, vaccines and technologies; leadership and governance; and financing. While we recognise that the immediate causes of the 2011 strikes were concerns about salaries and working conditions, we argue that a complex set of interacting factors underlie the strikers' demands, resonating with issues relating to five of the WHO building blocks. We argue that of the five, three are most significant and limit progress with all the others: a disgruntled health workforce, many of whom believe that striking is the only way to be heard; a lack of leadership by the government in understanding and responding to physicians' concerns; and a purported information insufficiency, manifest as a lack of critique and analysis that may have prevented those at the top from making a reliable diagnosis of the system's problems. This paper argues that there are cracks within the Israeli health system but that these are not irresolvable. The Israeli health system is a relatively new and popular health system, but there are no grounds for complacency