Pandora Pound

Safer Medicines

Much animal research into potential treatments for humans is wasted because it is poorly conducted and not evaluated through systematic reviews

Public acceptance of the use of animals in biomedical research is conditional on it producing benefits for humans. Pandora Pound and Michael Bracken argue that the benefits remain unproved and may divert funds from research that is more relevant to doctors and their patients

To be legitimate, research needs to be ethical, methodologically sound, of sufficient value to justify public expenditure and be transparent. Animal research has always been contested on ethical grounds, but there is now mounting evidence of poor scientific method, and growing doubts about its clinical value. So what of transparency? Here we examin...

Background The harm benefit analysis (HBA) is the cornerstone of animal research regulation and is considered to be a key ethical safeguard for animals. The HBA involves weighing the anticipated benefits of animal research against its predicted harms to animals but there are doubts about how objective and accountable this process is. Objectives i....

Background The pharmaceutical industry is in the midst of a productivity crisis and rates of translation from bench to bedside are dismal. Patients are being let down by the current system of drug discovery; of the several 1000 diseases that affect humans, only a minority have any approved treatments and many of these cause adverse reactions in hum...

Rat Trap comprehensively dismantles the case for animal research, revealing the shockingly poor science upon which most animal studies are based, and hence their ultimate futility. The author showcases the awe-inspiring technologies and approaches that would revolutionise medicine if only it were able to escape the stranglehold of animal research a...

New approach methodologies (NAMs) based on human biology enable the assessment of adverse biological effects of pharmaceuticals and other chemicals. Currently, however, it is unclear how NAMs should be used during drug development to improve human safety evaluation. A series of 5 workshops with 13 international experts (regulators, preclinical scie...

A commissioned article for the James Lind Library https://www.jameslindlibrary.org/articles/the-role-of-systematic-reviews-in-identifying-the-limitations-of-preclinical-animal-research-2000-2022/

Background Systematic reviews (SRs) are cornerstones of evidence-based medicine and have contributed significantly to breakthroughs since the 1980’s. However, preclinical SRs remain relatively rare despite their many advantages. Since 2011 the Dutch health funding organisation (ZonMw) has run a grant scheme dedicated to promoting the training, coac...

Drug-induced liver injury (DILI) causes one in three market withdrawals due to adverse drug reactions, causing preventable human suffering and massive financial loss. We applied evidence-based methods to investigate the role of preclinical studies in predicting human DILI using two anti-diabetic drugs from the same class, but with different toxicol...

Despite many decades of research, much of which has focused on studies in animals, we humans continue to suffer from multiple diseases for which there are no cures or treatments. It is now clear that insights provided by animal studies frequently fail to translate to humans, explaining the very high failure rate observed when new medicines are eval...

Abstract Systematic reviews are powerful tools with the potential to generate high quality evidence. Their application to animal studies has been instrumental in exposing the poor quality of these studies, as well as a catalyst for improvements in study design, conduct and reporting. It has been suggested that prospective systematic reviews of anim...

This chapter focuses on the use of animals in research into traumatic brain injury. It begins with a brief consideration of the epidemiology of human brain injury, before examining the various ways in which animals are used to “model” human brain injuries. The bulk of the chapter explores the impact of preclinical animal research on the treatment o...

Objectives Despite decades of research using animals to develop pharmaceutical treatments for patients who had a stroke, few therapeutic options exist. The vast majority of interventions successful in preclinical animal studies have turned out to have no efficacy in humans or to be harmful to humans. In view of this, we explore whether there is evi...

This chapter explores recent evidence relating to the quality, validity, and value of preclinical animal research (i.e., animal research that is expected to have relevance for humans), in the hope that it will provide a firm grounding for an updated ethics of animal research. The discussion is limited to the use of research animals as “models” of h...

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Additional procedures involving further animals. (DOCX)

Results of expert panel severity classifications. (DOCX)

References to the 228 animal studies. (DOCX)

Can sex and relationships education be effective if it’s not delivered in a way that is acceptable to young people? The government has announced its intention to make sex and relationships education (SRE) statutory in all secondary schools, and to make relationships education statutory in all primary schools.1 This is very welcome news. It is 17...

Supplementary Table 1. Alcohol use and drinking pattern of participants.

Objectives: Sex and relationship education (SRE) is regarded as vital to improving young people’s sexual health, but a third of schools in England lacks good SRE and government guidance is outdated. We aimed to identify what makes SRE programmes effective, acceptable, sustainable and capable of faithful implementation. Design: This is a synthesis...

Objectives Although sex and relationship education (SRE) represents a key strand in policies to safeguard young people and improve their sexual health, it currently lacks statutory status, government guidance is outdated and a third of UK schools has poor-quality SRE. We aimed to investigate whether current provision meets young people's needs. De...

Drinking is viewed by young people as a predominantly social activity which provides an opportunity for entertainment and bonding with friends. Using Bourdieu's concepts of habitus, field and capital, this article explores young people's attitudes and beliefs around alcohol use, influences on behaviour, and the role of peers, with a view to informi...

Improving laboratory animal science and welfare requires both new scientific research and insights from research in the humanities and social sciences. Whilst scientific research provides evidence to replace, reduce and refine procedures involving laboratory animals (the '3Rs'), work in the humanities and social sciences can help understand the soc...

Methodological Details. (DOCX)

Sex and relationship education (SRE) is a contested issue but debate is dominated by professionals, parents, and the media. We aimed to investigate young people's experiences of SRE.

Sociological theories seldom inform public health interventions at the community level. The reasons for this are unclear but may include difficulties in finding, understanding or operationalising theories. We conducted a study to explore the feasibility of locating sociological theories within a specific field of public health, adolescent risk-taki...

a b s t r a c t The idea of synthesising theory is receiving attention within public health as part of a drive to design theoretically informed interventions. Theory synthesis is not a new idea, however, having been debated by sociologists for several decades. We consider the various methodological approaches to theory syn-thesis and test the feasi...

Despite published work suggesting that public health interventions will probably be more effective when underpinned by relevant theory, this is often missing from their design and development. This absence might be because the theoretical published work is not easily accessible, because its sheer volume is overwhelming, or because the theories are...

Methods for reviewing and synthesising findings from quantitative research studies in health care are well established. Although there is recognition of the need for qualitative research to be brought into the evidence base, there is no consensus about how this should be done and the methods for synthesising qualitative research are at a relatively...

Provision of out-of-hours care in the UK National Health Service (NHS) has changed in recent years with new models of provision and the introduction of national quality requirements. Existing survey instruments tend to focus on users' satisfaction with service provision; most were developed without undertaking supporting qualitative fieldwork. In t...

Since 2000, out-of-hours primary medical care services in the UK have undergone major changes in the organisation and delivery of services in response to recommendations by the Carson Review and more recently, through the new General Medical Services Contract (GMS2). People calling their general practice in the evening or at weekends are redirected...

The study aimed to synthesise qualitative studies of lay experiences of medicine taking. Most studies focused on the experience of those not taking their medicine as prescribed, with few considering those who reject their medicines or accept them uncritically. Most were concerned with medicines for chronic illnesses. The synthesis revealed widespre...

Interest in how qualitative health research might be used more widely to inform health policy and medical practice is growing. Synthesising findings from individual qualitative studies may be one method but application of conventional systematic review methodology to qualitative research presents significant philosophical and practical challenges....

EDITOR—As Dobson notes, the House of Lords Select Committee on Animals in Scientific Procedures concluded that animal experiments were necessary but that more needs to be done to develop and promote alternative methods.1 Although it is clear that the committee sought the views and opinions of a wide range of experts, we were struck throughout by t...

The purpose of this work was to investigate how stroke rehabilitation professionals understand the concept of motivation and the ways that they use this concept in their clinical practice. This qualitative study used semistructured, in-depth interviews with the professionals working in the stroke unit of an inner-city teaching hospital in the UK. M...

Stroke is popularly conceived of as an illness which shatters lives. The discourse of shattered lives, articulated more generally within the sociological literature on chronic illness as ‘biographical disruption’, is examined with reference to the experience of a sample of predominantly elderly, working class people living in the East End of London...

Editor—We welcome the application of systematic reviews to the analysis of effective, healthy public policy.1 In the West Midlands we have applied Campbell principles through a public health research forum over the past two years. We have refined a shortlist of public policy interventions in education, criminal justice, and health fields through a...

Stroke patients' care in hospital tends to be poorly organised, with poor communication and a lack of information being frequent sources of complaint. The purpose of this study was to evaluate whether a patient-held record (PHR) would result in greater patient satisfaction and better care planning for stroke patients. A time series control (6 month...

The aim of this study was to identify aspects of the process of care that might help explain the improved outcomes associated with stroke units. Three different care settings for stroke patients, an elderly care unit and general medical ward in an inner-city teaching hospital and a stroke unit in another teaching hospital in the same city, were com...

To explore the attitudes and beliefs of stroke patients identified by professionals as having either "high" or "low" motivation for rehabilitation. Qualitative study with semistructured interviews. The stroke unit of an inner city teaching hospital. 22 patients with stroke who were undergoing rehabilitation; 14 with high motivation for rehabilitati...

Background: Comparative studies of patient outcomes consistently find that variations cannot be explained by case mix alone, suggesting that differences in the process of care may contribute to variations in outcome. We sought to describe local medical and social services available to patients participating in a multinational study of stroke servic...

Rehabilitation professionals have long suspected that a patient's motivation plays an important role in determining the outcome of therapy, despite the lack of a clear definition of the phenomenon. The fact that such a subjective concept is commonly used by clinicians prompted this investigation into the range and nature of professional understandi...

The objective of this study was to investigate associations between social engagement and health and social variables. Cross-sectional analysis of questionnaire data from a national cohort study was carried one. Participants were 5,905 men aged 51-70 years, from 24 general practices from 24 British towns. A nine-item social engagement scale was use...

Patients on stroke units have better outcomes but it is not known why. We investigated the process of care on a stroke unit, an elderly care unit and a general medical ward. Comparison of the three settings was by non-participant observation of 12 patients in each. Data were analysed using multi-level modelling methods. Stroke unit patients spent m...

Background and purpose: patients on stroke units have better outcomes but it is not known why. We investigated the process of care on a stroke unit, an elderly care unit and a general medical ward. Methods: comparison of the three settings was by non-participant observation of 12 patients in each. Data were analysed using multi-level modelling meth...

People with stroke are often referred to in negative terms. The phrase 'stroke victim' suggests that they are regarded as passive and deserving of pity, whilst 'the burden of care' implicates them negatively as an encumbrance to others. Much of the literature focuses on how stroke devastates peoples' lives, again casting the person with the stroke...

People with stroke are often referred to in negative terms. The phrase 'stroke victim' suggests that they are regarded as passive and deserving of pity, whilst 'the burden of care' implicates them negatively as an encumbrance to others. Much of the literature focuses on how stroke devastates peoples' lives, again casting the person with the stroke...

Despite the volume of research into patient satisfaction, it is not clear whether satisfaction ratings reflect differences in care received after stroke or the characteristics of patients. The aim of this study is to test the hypothesis that patient satisfaction is independently related to differences in care received after stroke. Stroke patients...

To explore the views of therapists working with stroke patients on the use of a patient-held record (PHR) for stroke patients. A PHR was developed in the form of a pocket-sized booklet (21 cm x 14.5 cm) in which staff recorded information relating to the patient's management. The aim of the PHR was to facilitate communication and involve patients m...

To explore subjective accounts of the consequences of stroke. Qualitative methods using depth interviews. Forty people sampled ten months post stroke from a hospital stroke register which was established in two adjacent health districts in North Thames Regional Health Authority. Interviewees reported a number of ways in which the stroke had affecte...

Stroke has traditionally been considered, both by lay people and by many people working within the health services, to be a tragic yet essentially uninteresting condition, possibly because of its associations with old age, chronicity and the widespread perception that very little can be done about it. This study explored health professionals' views...

A total of 361 consecutive admissions to hospital with acute stroke were followed up to examine the determinants of handicap 1 year and 2-3 years later. Handicap was measured using the London Handicap Scale, and data were collected on initial stroke severity, disability, mood and sociodemographic variables. Ninety-five of 170 survivors returned han...

To explore which components of care were valued by patients admitted to hospital following a stroke. Qualitative study using in depth interviews 10 months after the stroke. Two adjacent districts in North Thames Regional Health Authority. 82 survivors of stroke taken consecutively from a stroke register, 40 of whom agreed to be interviewed. Patient...

We performed a prospective observational study using a stroke register, case-note review and survey of carers with 6 months of follow-up in two adjacent health districts in East London. District 1 was a teaching district and had no special stroke service; District 2 had a comprehensive stroke service comprising stroke unit, review of all stroke adm...

Scales that measure independence in the basic self-care activities of daily living (ADLs) suffer from ceiling effects when applied to an outpatient population. The instrumental activities of daily living (IADL) measures, which assess the performance of tasks required for independence at home are more appropriate. However, validity evaluation of IAD...

This study aimed to cross validate the Guy's prognostic score in a new sample of patients of all ages admitted to hospital with a stroke and to devise and test a simpler version (the G-score). 361 consecutive acute patients with stroke who had been admitted to the acute hospitals in two adjacent health districts in East London were recruited and fo...

The Barthel Index is the best known and most popular activities of daily living (ADL) scale. Many studies have confirmed its validity and it has been validated for many different methods of administration. These include direct observation, interview of patient carer or nurse and telephone. The aim of this study was to devise and test the reliabilit...

To describe the components of physiotherapy valued by survivors of a stroke. Qualitative study using in-depth interviews. Two adjacent districts in North East Thames Regional Health Authority. 82 survivors of stroke taken consecutively from a stroke register when they reached the tenth month after their stroke, 40 of whom agreed to be interviewed....

Patient satisfaction with stroke services is a key aspect of the evaluation of the quality of services but there are no adequate means of assessing satisfaction in this area. A questionnaire derived from in-depth interviews was piloted on two samples. The resulting questionnaire consisted of two sections, one on inpatient services (Hospsat) and the...

To develop a carer satisfaction questionnaire for use as an outcome measure in stroke, to test the measure for reliability and validity, and to survey levels of carer satisfaction with services for stroke patients. Postal survey of carer satisfaction with stroke services was carried out using the questionnaire we developed and tested. Internal cons...

Assessments of outcome in stroke should include measures of the broader aims of rehabilitation, such as handicap, mood and perceived health, and these measures should be reliable. This study compared the test-retest reliability of the Barthel, Nottingham Extended Activities of Daily Living, Geriatric Depression Score (GDS) and the Nottingham Health...