Evidence-Based Policy: Where Is Our Theory of Evidence?

This article critically analyses the concept of evidence in evidence‐based policy, arguing that there is a key problem: there is no existing practicable theory of evidence, one which is philosophically‐grounded and yet applicable for evidence‐based policy. The article critically considers both philosophical accounts of evidence and practical treatments of evidence in evidence‐based policy. It argues that both fail in different ways to provide a theory of evidence that is adequate for evidence‐based policy. The article contributes to the debate about how evidence can and should be used to reduce contingency in science and in policy based on science

Managing Projects in an Uncertain and Volatile World: Engaging Stakeholders, and Building a Systemic View of Risk

As evidenced through both a historical and contemporary number of over-runs managing projects can be a risky business. Managers are faced with effectively working with a multitude of parties, dealing with a wealth of interlocking uncertainties and frequently undertaking these activities within a compressed timeframe. This paper describes a risk management process developed to assist managers facing such situations. The process explicitly engages a range of stakeholders using a group support system and causal mapping process and provides not only a comprehensive appreciation of the risks identified but also a greater understanding of their subtleties. Using a real case the paper will describe the process and outcomes along with its implications, before reflecting on the insights, limitations and future research

The friendly relationship between therapeutic empathy and person-centred care

‘Person-centred care’ and ‘empathy’ are receiving an increasing amount of attention in the healthcare literature. These two concepts are related; however, their relationship has hitherto not been rigorously explored. In this paper we review the differences and commonalities between common definitions of the two concepts. We found that therapeutic empathy requires both interpersonal understanding (achieved via one of several potential means) as well as caring action. We also found that person-centred care could be defined as follows: Person-centred care is therapeutic empathy (interpersonal understanding and caring action) together with continuity, coordination, teamwork, access and empowerment. Conceived this way, therapeutic empathy is included within person-centred care, but not vice-versa. There are three important consequences of our analysis. First, empathy training can provide one of the means by which (part of) person-centred care can be achieved. Second, researchers and practitioners can use our analysis of empathy and person-centred care to collaborate in approaches to both research and training. Third, philosophers, who sometimes take empathy to be a foundational concept in interpersonal understanding, can use our findings to inform their work. Finally, we hope to have provided more clarity not just on the relationship between empathy and person-centred care, but also on the nature of those two individual concepts

Learning from mixed OR method practice: The NINES case study

Despite continued interest in the use of mixed OR/MS methods, limited attention has been paid in the literature to generic lessons that could be gained from mixing methods . in practice. Many organisational problems demand the use of a mixed method approach and thus recognising and sharing lessons could prove beneficial to both practitioners and researchers. This paper reports on an in-depth evaluation of a case study involving risk identification and quantification of the Northern Isles New Energy Solutions (NINES) project which sought to trial and plan a new energy system. The intervention involved a mixed method approach and client feedback on the efficacy of the approach was sought. The evaluation reported in this paper is carried out using a set of themes taken from the literature and seeks to highlight transferable lessons. The set of lessons that emerge are presented along with their implications for both general OR modelling practice and the specific situation of mixing OR/MS methods. The paper concludes by discussing the implications of the work and directions for future work which will be of interest to both practitioners and researchers interested in mixed method OR/MS work

Effects of placebos without deception compared with no treatment: a systematic review and meta-analysis

Aim Our aim was to address the clinical efficacy of open-label placebos compared with no treatment by systematic review, and meta-analysis where possible. Methods We searched the Cochrane Injuries Group's Specialised Register, The Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE(R) In-Process & Other NonIndexed Citations (OvidSP), EMBASE (OvidSP), and clinical trials registers and screened reference lists. We ran the most recent search on April 27 2015. All randomised controlled trials of any medical condition, which had both open-label placebo and no-treatment or treatment as usual groups were included. Two authors independently applied the selection criteria and extracted data. The risk of bias of included studies was assessed using the Cochrane criteria. We used random-effects model for meta-analysis. Results After removing duplicates we screened 348 publications, assessed 24 articles for eligibility and identified 5 trials (260 participants) that met our inclusion criteria. The clinical conditions were: irritable bowel syndrome (IBS), depression, allergic rhinitis, back pain and attention deficit hyperactivity disorder (ADHD). The overall risk of bias was moderate. All 5 trials were eligible for meta-analysis. We found a positive effect for non-deceptive placebos (standardized mean difference (SMD) 0.88, 95% CI 0.62 to 1.14, P<0.00001, I2= 1%). Conclusions Open-label placebos appear to have favorable clinical outcomes, compared to no treatment or no additional treatment. Caution is warranted when interpreting the results due to the limitations including the small number of trials and lack of blinding. Larger definitive trials are now warranted to explore the potential patient benefit of open-label placebos

Effect of placental transfusion on neonatal resuscitation attempts

Objective: Overall, neonatal mortality has been shown to be reduced by: placental transfusion (the transfer of blood from the placenta to the neonatal circulation after birth); delayed cord clamping (DCM) (waiting for the umbilical cord to stop pulsating before clamping and cutting the cord); and umbilical cord milking (UCM) (clamping and cutting the cord immediately before milking the cord towards the neonate to expel remaining volume). This systematic review aimed to determine whether placental transfusion negatively impacts resuscitation by delaying it or has any effect on infant mortality, and to identify any barriers to performing it. Methods: CINAHL, MEDLINE, AMED and the British Nursing Index were searched using key terms to identify relevant English language publications between 2017 and 2019. Results: Five papers were selected for critical analysis—three randomised control trials and two cohort studies. Conclusion: Placental transfusion was not found to have a negative impact on neonatal resuscitation but, equally, had no significant effect on Apgar at 5 minutes; however, Apgar is a crude measure of infant mortality. The question remains around the proven multifaceted benefit of placental transfusion in the prehospital environment, which requires further research. There is evidence to suggest prehospital clinicians should be looking to change practice. Further research, considerations and consultations are required to ascertain the best way to implement the procedure with a balanced and proportionate approach considering neonatal thermoregulation and maternal management. The main reported barrier to placental transfusion was a lack of appropriate equipment

Impure placebo as an unsound concept and other problems in the paper by Howick et al. : [eLetter]

Kommentti artikkeliin Placebo Use in the United Kingdom: Results from a National Survey of Primary Care Practitioners, Plos One 8(3):e58247. doi: 10.1371/journal.pone.0058247Howick et al. have reported the findings of a survey that addressed the use of placebos among primary care practitioners in the United Kingdom. They adopted methodology similar to that used in previous studies performed in other countries; however, the use of this approach also means that they repeated the conceptual confusion of the previous surveys. Therefore the findings are not useful. ... The paper’s main finding “placebos are commonly used in UK primary care” is not correct. Only 0.9% of the responding general practitioners reported using pure placebos frequently. The frequency with which impure placebos are used is irrelevant because the concept is useless, as described above. Misleading a patient by administering inert substances without the explicit consent of the patient is unethical. The authors' proposal to “develop ethical and cost-effective placebos” is not possible because saving money by misleading patients is unethical. There is substantial conceptual confusion in the area of placebo and placebo-effect research, and the paper by Howick et al. does not help to reduce this confusion.Non peer reviewe

Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children

BACKGROUND: Neuraminidase inhibitors (NIs) are stockpiled and recommended by public health agencies for treating and preventing seasonal and pandemic influenza. They are used clinically worldwide. OBJECTIVES: To describe the potential benefits and harms of NIs for influenza in all age groups by reviewing all clinical study reports of published and unpublished randomised, placebo-controlled trials and regulatory comments. SEARCH METHODS: We searched trial registries, electronic databases (to 22 July 2013) and regulatory archives, and corresponded with manufacturers to identify all trials. We also requested clinical study reports. We focused on the primary data sources of manufacturers but we checked that there were no published randomised controlled trials (RCTs) from non-manufacturer sources by running electronic searches in the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE (Ovid), EMBASE, Embase.com, PubMed (not MEDLINE), the Database of Reviews of Effects, the NHS Economic Evaluation Database and the Health Economic Evaluations Database. SELECTION CRITERIA: Randomised, placebo-controlled trials on adults and children with confirmed or suspected exposure to naturally occurring influenza. DATA COLLECTION AND ANALYSIS: We extracted clinical study reports and assessed risk of bias using purpose-built instruments. We analysed the effects of zanamivir and oseltamivir on time to first alleviation of symptoms, influenza outcomes, complications, hospitalisations and adverse events in the intention-to-treat (ITT) population. All trials were sponsored by the manufacturers. MAIN RESULTS: We obtained 107 clinical study reports from the European Medicines Agency (EMA), GlaxoSmithKline and Roche. We accessed comments by the US Food and Drug Administration (FDA), EMA and Japanese regulator. We included 53 trials in Stage 1 (a judgement of appropriate study design) and 46 in Stage 2 (formal analysis), including 20 oseltamivir (9623 participants) and 26 zanamivir trials (14,628 participants). Inadequate reporting put most of the zanamivir studies and half of the oseltamivir studies at a high risk of selection bias. There were inadequate measures in place to protect 11 studies of oseltamivir from performance bias due to non-identical presentation of placebo. Attrition bias was high across the oseltamivir studies and there was also evidence of selective reporting for both the zanamivir and oseltamivir studies. The placebo interventions in both sets of trials may have contained active substances. Time to first symptom alleviation. For the treatment of adults, oseltamivir reduced the time to first alleviation of symptoms by 16.8 hours (95% confidence interval (CI) 8.4 to 25.1 hours, P 1000) and nausea whilst on treatment (RD 4.15%, 95% CI 0.86 to 9.51); NNTH = 25 (95% CI 11 to 116). AUTHORS' CONCLUSIONS: Oseltamivir and zanamivir have small, non-specific effects on reducing the time to alleviation of influenza symptoms in adults, but not in asthmatic children. Using either drug as prophylaxis reduces the risk of developing symptomatic influenza. Treatment trials with oseltamivir or zanamivir do not settle the question of whether the complications of influenza (such as pneumonia) are reduced, because of a lack of diagnostic definitions. The use of oseltamivir increases the risk of adverse effects, such as nausea, vomiting, psychiatric effects and renal events in adults and vomiting in children. The lower bioavailability may explain the lower toxicity of zanamivir compared to oseltamivir. The balance between benefits and harms should be considered when making decisions about use of both NIs for either the prophylaxis or treatment of influenza. The influenza virus-specific mechanism of action proposed by the producers does not fit the clinical evidence