An important step in narrowing the gap between approaches to the mind and approaches to the body came with the recognition in the early 2000s that the common factor associated with many of our major public health conditions such as heart disease, diabetes, and obesity was a pattern of autonomic imbalance (too much sympathetic nervous system and too little parasympathetic nervous system activity). This is one example of how persistent psychological stressors can lead a physical illness with a life of its own. While most of modern medicine continued to ignore the contributions of toxic stress to our common public health targets, Dean Ornish, MS, risked his career to find out if behavior changes could reverse heart disease.

Chapter 4 examines the wave of cases before international courts and tribunals (ICTs) against the most innovative tobacco control measures, focusing in particular on Philip Morris v Uruguay (ICSID) and Australia – Plain Packaging (WTO). It contends that the alleged ineffectiveness of the tobacco control measures was one of the key arguments of the claimants, who supported their claims by submitting a hefty amount of evidence. These evidentiary challenges presented novel and demanding tasks for adjudicators of ICTs. Against this backdrop, this chapter first analyses the nature and features of the evidentiary challenges to tobacco control measures (Section 4.2). Second, it reviews how the ICTs have assessed them, zooming in on the interpretation of flexibilities and the use of different sources of evidence (Section 4.3). The picture that emerges from this chapter is that of unnecessary, manufactured complexity. Shifting the discussions on tobacco control measures from the WHO/FCTC to trade and investment ICTs, the tobacco industry has effectively managed to masterfully use international law to its own advantage. It has reframed the debate, all while starting expensive and lengthy judicial proceedings that have taken almost a decade to be concluded.

Chapter 3 analyses how evidence has become a central element of the FCTC regime (2005–present). Section 3.1 captures the most important developments since the conclusion of the FCTC in 2003. Section 3.2 provides the theoretical framework of the chapter, focusing on the concept of path dependence in international organisations. Section 3.3 proceeds by showing that the development of the guidelines by the FCTC Conference of the Parties (COP) has been in effect a continuation of the strategy on evidence. Section 3.4 in turn highlights the second facet of the FCTC as an evidence-based regime, that is how the FCTC has mobilised new evidence at the national level. Sections 3.5 and 3.6 reflect on the consequences that the evidence-based approach has had on the outlook of the FCTC regime. Section 3.5 uses in-depth qualitative analysis to demonstrate that the evidence-based approach has reinforced the importance of the expertise of civil society organisations. Finally, Section 3.6 illustrates how the evidence-based approach has started to show its shortcomings in the work of the FCTC COP – particularly in the approach to new products like e-cigarettes (or ENDS) and in the (lack of) development of strategies to foster the implementation of tobacco control measures.

Violence and aggression never present themselves in a vacuum, yet this is typically the way policymakers approach the subject, its prevention and its management. Although guidelines exist in different sectors, too often little or no consideration is given to many of the wider issues in play, particularly the use of restraint when it becomes necessary. Despite the long-standing call for a common set of guidelines, we are only now looking at the introduction of the Restraint Reduction Network training standards, and it seems that anything approaching a set of common guidelines that all settings can embrace is a long way off. The aim of any good guidance seeking to influence practices in the prevention and management of violence and aggression should be to minimise the need for any restrictive intervention but where necessary to apply techniques as safely as possible within the relevant legislative framework. Certain staff in healthcare settings need to receive training to increase the organisation’s capacity and capability to deal with potentially violent situations without recourse to external agencies, such as police, who operate to a different set of standards to those within healthcare settings and who use techniques that healthcare staff would not wish to see used in their settings.

In this chpater, we review the standards and guidelines for adaptive trial designs and master protocols. Methodological rigour and transparent reporting are required in all clinical trials. Adaptive trial designs and master protocols are no exception. The standard reporting guidelines and risk-of-bias assessments for conventional trials can be applied to adaptive trial designs and master protocols. Adaptive trial designs have pre-planned adaptations and analysis plans that are specified in a formal way that outline how the data will be used to guide the design. Planning of adaptive clinical trials, basket trials, umbrella trials, and platform trials will require early engagement with the stakeholders and methodologists to think through potential hurdles and challenges of the statistical design and its implementation.

Lying in after giving birth has a long tradition but carries a risk of thrombosis. Blood clots form in leg veins and may embolise to the lungs, causing death. Early CEMD Reports did not recognise the benefits of early ambulation but divided thromboembolism deaths into three groups – during pregnancy, after vaginal delivery and after caesarean section. The Reports identified risk factors including age, obesity and caesarean section, and found that warning symptoms were being ignored. Shorter hospital stay reduced the number of deaths after vaginal birth. Caesarean section rates rose and an Enquiry into Perioperative Deaths (modelled on the CEMD) revealed the risk factors for post-operative thromboembolism. An 1995 an RCOG report advised on preventive measures including anticoagulants, previously avoided lest they cause bleeding. A sharp fall in deaths after caesarean section followed in 1997-9. By then thromboembolism was the leading Direct cause of maternal death and the benefits of guidelines had become clear. In 2004 the RCOG published a guideline on thromboprophylaxis in pregnancy and in 2006-8 thomboembolism fell to third place among causes of Direct death.

Haemorrhage is the leading global cause of maternal death. In the 1930s transfusion services were established in British cities, followed in 1946 by a national blood transfusion service. Drugs to cause uterine contraction were developed: ergometrine in the 1930s and oxytocin in the 1950s. In the 1930s obstetric flying squads were established, first in Bellshill and Newcastle, and in Birmingham by Hilda Lloyd, the first female RCOG president. They saved many lives but disappeared as home births fell. In the 1950s iron supplements were introduced into antenatal care to combat pre-existing anaemia. CEMD Reports highlighted the risk of vaginal examination in pregnancy. In the 1970s placental localisation by ultrasound became available. The Reports pointed out that intractable bleeding may need hysterectomy and the 1979-81 Report included the first guideline on emergency treatment of haemorrhage. Guidelines remain essential today, for example in planning care for women who refuse blood transfusion. Ectopic pregnancy can cause catastrophic bleeding in early pregnancy. The Reports showed that ethnic minorities are at higher risk and immediate surgery can be life-saving.

Hypertension associated with proteinuria occurs in pre-eclampsia, which can progress to eclampsia (convulsions) and is a major cause of maternal death globally. CEMD Reports reminded doctors that high blood pressure may have other, much rarer, causes. Early diagnosis is important but in the 1950s signs of pre-eclampsia were sometimes taken lightly, allowing eclampsia to occur. The 1979-81 Report recommended that each region should have a specialist team to advise about preventing respiratory and clotting complications. Adherence to guidelines required a major culture shift. Deaths from these complications almost disappeared and by the year 2000 the main cause of death was brain haemorrhage. The Report emphasised the need for prompt administration of antihypertensive drugs. In 1995 a controlled trial showed that magnesium sulphate, the treatment favoured in the USA, was more effective than UK treatments for eclampsia. In 2002 the MAGPIE trial, led by Prof Lelia Duley in Oxford and involving 10,000 women in 33 countries, showed that it is also effective in pre-eclampsia. The rate of fits has fallen and, since 2010, the number of deaths has been in single figures.

Chapter 4 examines the historical trends of how the three health issues of obesity, opioid use disorder, and depression in older adults have increased in prevalence over the last several decades. The chapter describes the current guidelines and practices for how health care is delivered for these patient populations and draws from perspectives and stories from health care settings.