Planning and implementing safety management systems

This thesis describes a study of the content and applicability of BS8800:1996 Guide to occupational health and safety management systems. The research is presented chronologically, with literature review and content analysis of SMS related guides and standards interwoven with two elements of qualitative empirical work. The first of these was carried out shortly after publication of BS8800 in 1996, a 'before-the-event' investigation of how organisations were intending to approach SMS implementation. The challenges faced by these organisations are reviewed against standard management theory, suggesting that the initial motivation for SMS implementation governs the approach organisations will adopt to guidance such as BS8800. The second phase of empirical work was undertaken in the context of OHSAS 18001, an auditable protocol based on BS8800, which allows organisations to certify their safety management systems. A discussion of the evolution of certifiable safety management system is presented, highlighting the similarities and differences between this, BS8800, SMS and wider management system standards. A case study then reviews the experiences of a catering company that implemented 18001, motivated by the opportunity for certification as a business benefit. The empirical work is used to comment on the guidance provided by BS8800, within its evolved role as guidance organisations may use for implementation of a SMS to be certified according to the specifications of OHSAS 18001. It is suggested that optimal implementation is facilitated by initial status review, continual improvement and the use of annexes, where there are used to make changes to the existing safety management system. This thesis concludes with a discussion of these elements, highlighting pertinent areas within BS8800 where revision or amendment may be appropriate.

Undermining patient and public engagement and limiting its impact:the consequences of the Health and Social Care Act 2012 on collective patient and public involvement

Patient and public involvement has been at the heart of UK health policy for more than two decades. This commitment to putting patients at the heart of the British National Health Service (NHS) has become a central principle helping to ensure equity, patient safety and effectiveness in the health system. The recent Health and Social Care Act 2012 is the most significant reform of the NHS since its foundation in 1948. More radically, this legislation undermines the principle of patient and public involvement, public accountability and returns the power for prioritisation of health services to an unaccountable medical elite. This legislation marks a sea-change in the approach to patient and public involvement in the UK and signals a shift in the commitment of the UK government to patient-centred care. © 2013 John Wiley & Sons Ltd.

"Trade creep" and implications of the Transatlantic Trade and Investment Partnership Agreement for the United Kingdom National Health Service

The ambitious and comprehensive Transatlantic Trade and Investment Partnership Agreement (TTIP/TAFTA) agreement between the European Union and United States is now being negotiated and may have far-reaching consequences for health services. The agreement extends to government procurement, investment, and further regulatory cooperation. In this article, we focus on the United Kingdom National Health Service and how these negotiations can limit policy space to change policies and to regulate in relation to health services, pharmaceuticals, medical devices, and health industries. The negotiation of TTIP/TAFTA has the potential to "harmonize" more corporate-friendly regulation, resulting in higher costs and loss of policy space, an example of "trade creep" that potentially compromises health equity, public health, and safety concerns across the Atlantic.

Comparative efficacy and safety of biosimilar infliximab and other biological treatments in ankylosing spondylitis: systematic literature review and meta-analysis.

OBJECTIVES: To compare the efficacy and safety of infliximab-biosimilar with other biological drugs for the treatment of active ankylosing spondylitis (AS). METHODS: Systematic literature review for randomized controlled trials (RCTs) with adalimumab, etanercept, golimumab, infliximab and infliximab-biosimilar in AS was performed and indirect meta-analysis (Bayesian mixed treatment comparison) was carried out. The proportion of patients reaching 20 % improvement by the assessment of Spondyloarthritis International Society response criteria (ASAS20) at weeks 12 and 24 was used as efficacy endpoints, and the occurrence of serious adverse events at week 24 was applied to compare the safety of the biologicals. RESULTS: Altogether, 13 RCTs, identified by the systematic literature search, were included in the analysis. Results on the ASAS20 efficacy endpoint were reported for week 12 in 12 RCTs involving 2,395 patients, and for week 24 in 5 RCTs comprising 1,337 patients. All the five biological agents proved to be significantly superior to placebo. Infliximab showed the highest odds ratio (OR) of 7.2 (95 % CI 3.68-13.19) compared to placebo, followed by infliximab-biosimilar with OR 6.25 (95 % CI 2.55-13.14), both assessed at week 24. No significant difference was found between infliximab-biosimilar and other biological treatments regarding their efficacy and safety. CONCLUSIONS: This is the first study which includes a biosimilar drug in the meta-analysis of biological treatments in AS. The results have proven the similar efficacy and safety profile of infliximab-biosimilar treatment compared to other biologicals.

Efficacy and safety of infliximab-biosimilar compared to other biological drugs in rheumatoid arthritis: a mixed treatment comparison.

OBJECTIVE: The aim of this meta-analysis was to compare the efficacy and safety of infliximab-biosimilar and other available biologicals for the treatment of rheumatoid arthritis (RA), namely abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab and tocilizumab. METHODS: A systematic literature review of MEDLINE database until August 2013 was carried out to identify relevant randomized controlled trials (RCTs). Bayesian mixed treatment comparison method was applied for the pairwise comparison of treatments. Improvement rates by the American College of Rheumatology criteria (ACR20 and ACR50) at week 24 were used as efficacy endpoints, and the occurrence of serious adverse events was considered to assess the safety of the biologicals. RESULTS: Thirty-six RCTs were included in the meta-analysis. All the biological agents proved to be superior to placebo. For ACR20 response, certolizumab pegol showed the highest odds ratio (OR) compared to placebo, OR 7.69 [95 % CI 3.69-14.26], followed by abatacept OR 3.7 [95 % CI 2.17-6.06], tocilizumab OR 3.69 [95 % CI 1.87-6.62] and infliximab-biosimilar OR 3.47 [95 % CI 0.85-9.7]. For ACR50 response, certolizumab pegol showed the highest OR compared to placebo OR 8.46 [3.74-16.82], followed by tocilizumab OR 5.57 [95 % CI 2.77-10.09], and infliximab-biosimilar OR 4.06 [95 % CI 1.01-11.54]. Regarding the occurrence of serious adverse events, the results show no statistically significant difference between infliximab-biosimilar and placebo, OR 1.87 [95 % CI 0.74-3.84]. No significant difference regarding efficacy and safety was found between infliximab-biosimilar and the other biological treatments. CONCLUSION: This is the first indirect meta-analysis in RA that compares the efficacy and safety of biosimilar-infliximab to the other biologicals indicated in RA. We found no significant difference between infliximab-biosimilar and other biological agents in terms of clinical efficacy and safety.

The use of treatment theories and procedures for postural control in adult with hemiplegia: A national survey

This study investigated the use of treatment theories and procedures for postural control training used by Occupational Therapists (OTs) when working with hemiplegic adults who have had cerebrovascular accident (CVA) or traumatic brain injury (TBI). The method of data collection was a national survey of 400 randomly selected physical disability OTs with 127 usable surveys returned. Results showed that the most common used treatment theory was neurodevelopmental treatment (NDT), followed by motor relearning program (MRP), proprioceptive neuromuscular facilitation (PNF), Brunnstrom's approach, and the approach of Rood. The most common treatment posture used was sitting, followed by standing, mat activity, equilibrium reaction training, and walking. The factors affecting the use of various treatment theories procedures were years certified, years of clinical experience, work situation and work status. Pearson correlation coefficient analyses found significant positive relationships between treatment theories and postures. There were significant high correlations between usage of all pairs of treatment procedures. ^

MODERN SPORT COACHING AND THE LAW: IMPLICATIONS FOR COACH EDUCATION

Introduction
The intersection between the law of negligence and sport coaching in the UK is a developing area (Partington, 2014; Kevan, 2005). Crucially, since the law of negligence may be regarded as generally similar everywhere (Magnus, 2006), with the predominance of volunteer coaches in the UK reflective of the majority of countries in the world (Duffy et al., 2011), a detailed scrutiny of this relationship from the perspective of the coach uncovers important implications for coach education beyond this jurisdiction.  
Argumentation
Fulfilment of the legal duty of discharging reasonable care may be regarded as consistent with the ethical obligation not to expose athletes to unreasonable risks of injury (Mitten, 2013). More specifically, any ‘profession’ requiring ‘special skill or competence’ (Bolam v Friern Hospital Management Committee [1957] 1 WLR 582), including the coaching of sport (e.g., Davenport v Farrow [2010] EWHC 550), requires a higher standard of care to be displayed than would be expected of the ordinary reasonable person (Lunney & Oliphant, 2013; Jones & Dugdale, 2010). For instance, volunteer coaches with no formal qualifications (e.g., Fowles v Bedfordshire County Council [1996] ELR 51) would be judged by this benchmark of professional liability (Powell & Stewart, 2012). Further, as the principles of coaching are constantly assessed and revised (Cassidy et al., 2009; Taylor & Garratt, 2010), so too is the legal standard of care required of coaches (Powell & Stewart, 2012). Problematically, ethical concerns may include coaches being unwilling to increase knowledge, abusive treatment of players and incompetence/inexperience (Haney et al., 1998). These factors accentuate coaches’ exposure to civil liability.
Implications
It is imperative that coaches have an awareness of this emerging intersection and develop a ‘proactive risk assessment lens’ (Hartley, 2010). In addition to supporting the professionalisation of sport coaching, coach education/CPD focused on the legal and ethical aspects of coaching (Duffy et al., 2011; Telfer, 2010; Haney et al., 1998) would enhance the safety and welfare of performers, safeguard coaches from litigation risk, and potentially improve all levels of coaching (Partington, 2014). Interestingly, there is evidence to suggest a demand from coaches for more training on health and safety issues, including risk management and (ir)responsible coaching (Stirling et al., 2012). Accordingly, critical examination of the issue of negligent coaching would inform coach education by: enabling the modelling and sharing of best practice; unpacking important ethical concerns; and, further informing the classification of coaching as a ‘profession’.

Efficacy and Safety of Radium-223 Dichloride in Symptomatic Castration-resistant Prostate Cancer Patients With or Without Baseline Opioid Use From the Phase 3 ALSYMPCA Trial

Background: The phase 3 ALSYMPCA trial enrolled metastatic castration-resistant prostate cancer patients with or without baseline opioid use.

Objective: To assess the efficacy and safety of radium-223 dichloride (radium-223) versus placebo in ALSYMPCA patients by baseline opioid use.

Design, setting, and participants: Nine hundred and twenty one patients enrolled at 136 centers globally.

Intervention: Radium-223 (50 kBq/kg, intravenous injection) every 4 wk for six cycles or matching placebo, each plus best standard of care.

Outcome measurements and statistical analysis: Primary endpoint (overall survival [OS]), main secondary efficacy endpoints, and safety were evaluated by baseline opioid use. Additional analyses included time to first opioid use, time to first external beam radiation therapy for bone pain, and safety of concomitant external beam radiation therapy.

Results and limitations: At baseline, 408 (44%) patients had no pain and no analgesic use or mild pain with nonopioid therapy (World Health Organization ladder pain score 0–1 [nonopioid subgroup]), and 513 (56%) had moderate pain with occasional opioids or severe pain with regular daily opioids (World Health Organization ladder pain score 2–3 [opioid subgroup]). Radium-223 significantly prolonged OS versus placebo in nonopioid (hazard ratio [HR] = 0.70; 95% confidence interval [CI]: 0.52–0.93; p = 0.013) and opioid (HR = 0.68; 95% CI: 0.54–0.86; p = 0.001) subgroups, and significantly reduced risk of symptomatic skeletal events versus placebo, regardless of baseline opioid use (nonopioid subgroup: HR = 0.56, 95% CI: 0.39–0.82, p = 0.002; opioid subgroup: HR = 0.72, 95% CI: 0.53–0.98, p = 0.038). Time to first opioid use for bone pain was significantly delayed with radium-223 versus placebo (HR = 0.62, 95% CI: 0.46–0.85,p = 0.002). Adverse event incidences were similar between opioid subgroups.

Conclusions: Radium-223 versus placebo significantly prolonged OS and reduced symptomatic skeletal event risk with a favorable safety profile in castration-resistant prostate cancer patients with symptomatic bone metastases, regardless of baseline opioid use.

Patient summary: In this ALSYMPCA opioid subgroup analysis, baseline symptom levels did not appear to impact radium-223 dichloride efficacy or safety.

Making life better: Monitoring the wider social determinants of health and well being - key indicators 2015

This report monitors progress against the key indicators of Northern Ireland’s public health strategy ‘Making Life Better’ launched by the Department of Health, Social Services & Public Safety (DHSSPS) in 2014. In addition to presenting the revised baseline positions for each of the key indicators of the framework, the report also monitors progress against each indicator by comparing the latest position with the baseline.

Iowa Department of Public Health, Occupational Health & Safety Surveillance Program Annual Report, July 1, 2013- June 30, 2014, August 1, 2014

The mission of the Iowa OHSSP is to promote and protect the health and safety of Iowans in the workplace. The fundamental or core program provides administrative coordination and continuity across all IDPH OHSSP projects, explores options to improve the surveillance and data translation capacity of the entire program, and provides outreach, dissemination, and evaluation functions to support each project. The core program is also responsible for the Occupational Health Indicators project and Adult Blood Lead Epidemiology and Surveillance (ABLES), as well as working with external partner projects and reports.

The impact of cooking methods on the nutritional quality and safety of chicken breaded nuggets

The impact of cooking methods (industrial pre-frying, deep-fat frying and baking) on the nutritional quality and safety of chicken breaded nugget samples from supermarket and commercial brands was evaluated. The changes in the quality characteristics (nutritional composition, fatty acids profile, cholesterol and salt) of the fried food and frying oil, after ten consecutive frying operations, were evaluated. The total fat content of nuggets varied between 10.9 and 22.7 g per 100 g of edible portion and the salt content ranged from 0.873 to 1.63 g per 100 g. Taking into account one portion of nuggets, the daily intake of salt can reach 49%, which can have a significant impact on the health of those who regularly consume this type of food, especially considering the prevalence of hypertension around the world. The analysed chicken breaded nuggets are rich in unsaturated fatty acids, which have been related with potential health benefits, namely regarding cardiovascular diseases. The cholesterol content of baked samples was two times higher when compared with the fried ones. The trans fatty acids and polar compounds contents of the frying oil used for frying significantly increased, but the values were still away from the maximum recommended by legal entities for its rejection. From a nutritional point of view, it is possible to conclude that the applied cooking methods can significantly influence the nutritional quality and safety of the analysed chicken breaded nuggets. This study will contribute to important knowledge on how the applied cooking methods can change the nutritional quality and safety of foods, namely of chicken nuggets, and can be very useful for dietary recommendations and nutritional assessment.