Objectives To conduct an independent evaluation of the first phase of the Health Foundation’s Safer Patients Initiative (SPI), and to identify the net additional effect of SPI and any differences in changes in participating and non-participating NHS hospitals. Design Mixed method evaluation involving five substudies, before and after design. Setting NHS hospitals in the United Kingdom. Participants Four hospitals (one in each country in the UK) participating in the first phase of the SPI (SPI1); 18 control hospitals. Intervention The SPI1 (...) was a compound (multi-component) organisational intervention delivered over 18 months that focused on improving the reliability of specific frontline care processes in designated clinical specialties and promoting organisational and cultural change. Results Senior staff members were knowledgeable and enthusiastic about SPI1. There was a small (0.08 points on a 5 point scale) but significant (P<0.01) effect in favour of the SPI1 hospitals in one of 11 dimensions of the staff questionnaire (organisational climate). Qualitative evidence showed only modest penetration of SPI1 at medical ward level. Although SPI1 was designed to engage staff from the bottom up, it did not usually feel like this to those working on the wards, and questions about legitimacy of some aspects of SPI1 were raised. Of the five components to identify patients at risk of deterioration—monitoring of vital signs (14 items); routine tests (three items); evidence based standards specific to certain diseases (three items); prescribing errors (multiple items from the British National Formulary); and medical history taking (11 items)—there was little net difference between control and SPI1 hospitals, except in relation to quality of monitoring of acute medical patients, which improved on average over time across all hospitals. Recording of respiratory rate increased to a greater degree in SPI1 than in control hospitals; in the second six hours after admission recording increased from 40% (93) to 69% (165) in control hospitals and from 37% (141) to 78% (296) in SPI1 hospitals (odds ratio for “difference in difference” 2.1, 99% confidence interval 1.0 to 4.3; P=0.008). Use of a formal scoring system for patients with pneumonia also increased over time (from 2% (102) to 23% (111) in control hospitals and from 2% (170) to 9% (189) in SPI1 hospitals), which favoured controls and was not significant (0.3, 0.02 to 3.4; P=0.173). There were no improvements in the proportion of prescription errors and no effects that could be attributed to SPI1 in non-targeted generic areas (such as enhanced safety culture). On some measures, the lack of effect could be because compliance was already high at baseline (such as use of steroids in over 85% of cases where indicated), but even when there was more room for improvement (such as in quality of medical history taking), there was no significant additional net effect of SPI1. There were no changes over time or between control and SPI1 hospitals in errors or rates of adverse events in patients in medical wards. Mortality increased from 11% (27) to 16% (39) among controls and decreased from 17% (63) to 13% (49) among SPI1 hospitals, but the risk adjusted difference was not significant (0.5, 0.2 to 1.4; P=0.085). Poor care was a contributing factor in four of the 178 deaths identified by review of case notes. The survey of patients showed no significant differences apart from an increase in perception of cleanliness in favour of SPI1 hospitals. Conclusions The introduction of SPI1 was associated with improvements in one of the types of clinical process studied (monitoring of vital signs) and one measure of staff perceptions of organisational climate. There was no additional effect of SPI1 on other targeted issues nor on other measures of generic organisational strengthening. (shrink)

The article considers the nature of legalistic, or formal, conceptions of the rule of law, focusing particularly on the work of Joseph Raz and Albert Venn Dicey. It asks how such apparently narrow conceptions are generated, and how far they can resist including broader social claims. It concludes that the rationale behind legalistic conceptions compels them to address issues of poverty and the literacy of the law's subjects. However, legalistic conceptions of the rule of law can still avoid sliding into (...) the wider non‐legalistic models advanced by writers such as T. R. S. Allan. (shrink)

In this paper we want to briefly illustrate the ways in which technical, ethical and political judgements of various kinds are interwoven in the processes of healthcare decision-making in the UK. Drawing upon the research for the “Choices in Health Care” project we will borrow the notion of the hidden curriculum from education to illuminate the nature of resource allocation decision processes. In particular we will indicate some of the fundamental but largely hidden political factors in play in these processes (...) and the importance of the inchoate and implicit notion of “NHS values” in shaping UK resource allocation policies. We suggest that these more diffuse, holistic and system level value judgements are both central to understanding priority setting and at the same time difficult to reduce or abstract out into lists of single values/principles. (shrink)

In this article the relationship between Parliament and courts is examined. The views of writers on sovereignty are considered and criticized. Two criticisms of the sovereignty theorists are made: first, that they wrongly assume that a legal system must attribute supreme legal power to a single source and, second, that they wrongly assume that statutes in the English system constitute absolute exclusionary reasons for decision. It is contended that legal systems, can, and the English Constitution does, contain multiple unranked sources (...) of law. Hart's rule of recognition and Kelsen's Grundnorm are considered and compared, and found to be insufficiently flexible to meet the realities of the English Constitution. A more complicated model of judicial reactions to statutes is proposed, and decisions of the judges that run contrary to the law as set down in the statute are considered. It is contended that the relationship of the courts to Parliament ought not to be considered a purely legal issue; it also has a political dimension. (shrink)

What is good prescribing? In this paper we will look at the kinds of criteria which are relevant to evaluating prescribing. In particular we wish to challenge, or at least re-frame, the picture of prescribing as an essentially technical process. In so doing we hope to indicate something more general about the power, and limitations, of technical rationality in health care, and to contribute something to work in health care technology assessment. Finally we hope this discussion will act as a (...) stimulus towards a much needed revision of the way ‘good’ prescribing is defined by current policies, guidelines and protocols. (shrink)

The use of informed consent for surgery or research has been widely studied; however, its use in other areas of clinical practice has received less attention. This study investigates how doctors and nurses understand informed consent in relation to the prescription and administration of medicines in secondary care. It uses a qualitative analysis of semi-structured in-depth interviews with 19 doctors and 6 nurses recruited from various specialties in a teaching hospital. The results indicate a striking gap between official and actual (...) standards of practice. Providing information, assuring adherence and communication about potential treatment harms were raised as key issues instead of the principal goals of informed consent. Rather than simply treating these findings as support for a 'deficit' account of professionalism, the paper concludes that we need a richer and more grounded account of exactly when hospital medication decisions need to be subjected to the highest standards of informed consent. (shrink)