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1.  How innovative are new drugs launched in the UK? A retrospective study of new drugs listed in the British National Formulary (BNF) 2001–2012 
BMJ Open  2014;4(10):e006235.
Innovative new drugs offer potential benefits to patients, healthcare systems, governments and the pharmaceutical industry. Recent data suggest annual numbers of new drugs launched in the UK have increased in recent years, and we sought to understand whether this represents increasing numbers of highly innovative drugs being made available or the introduction of increasing numbers of drugs with limited additional therapeutic value.
Design and setting
Retrospective observational study of new drug entries in the British National Formulary (BNF).
Primary and secondary outcome measures
Number of new drugs launched in the UK each year (based on first appearance in the BNF) from 2001 to 2012, including new chemical entities and new biological drugs, categorised by degree of innovativeness according to published criteria that incorporate both clinical usefulness and the nature of the innovation.
Highly innovative, moderately innovative and slightly innovative drugs made up 26%, 18% and 56% of all newly launched drugs, respectively, for the study period (n=290). There was an upward trend in annual numbers of slightly innovative drugs from 2004 onwards (R2=0.44), which aligned closely with the recovery in total numbers of new drugs launched each year since that time. There were no discernible time trends in the highly or moderately innovative categories. New drugs for malignancy and skin disease were most likely to be characterised as highly innovative (44% and 57%, respectively).
Highly innovative new drugs comprise only around a quarter of all new drug launches in the UK. In contrast, drugs categorised as only slightly innovative comprised well over half of all new drugs and annual numbers in this category are increasing. Current policy initiatives that seek to increase the supply of innovative new drugs have long-lead times to impact, and will need careful assessment to ensure they deliver their aims without unintended consequences.
PMCID: PMC4212185  PMID: 25344485
Pharmaceuticals; Innovation; New drug launches; time trends; United Kingdom
2.  The orthopaedic error index: development and application of a novel national indicator for assessing the relative safety of hospital care using a cross-sectional approach 
BMJ Open  2013;3(11):e003448.
The Orthopaedic Error Index for hospitals aims to provide the first national assessment of the relative safety of provision of orthopaedic surgery.
Cross-sectional study (retrospective analysis of records in a database).
The National Reporting and Learning System is the largest national repository of patient-safety incidents in the world with over eight million error reports. It offers a unique opportunity to develop novel approaches to enhancing patient safety, including investigating the relative safety of different healthcare providers and specialties.
We extracted all orthopaedic error reports from the system over 1 year (2009–2010).
Outcome measures
The Orthopaedic Error Index was calculated as a sum of the error propensity and severity. All relevant hospitals offering orthopaedic surgery in England were then ranked by this metric to identify possible outliers that warrant further attention.
155 hospitals reported 48 971 orthopaedic-related patient-safety incidents. The mean Orthopaedic Error Index was 7.09/year (SD 2.72); five hospitals were identified as outliers. Three of these units were specialist tertiary hospitals carrying out complex surgery; the remaining two outlier hospitals had unusually high Orthopaedic Error Indexes: mean 14.46 (SD 0.29) and 15.29 (SD 0.51), respectively.
The Orthopaedic Error Index has enabled identification of hospitals that may be putting patients at disproportionate risk of orthopaedic-related iatrogenic harm and which therefore warrant further investigation. It provides the prototype of a summary index of harm to enable surveillance of unsafe care over time across institutions. Further validation and scrutiny of the method will be required to assess its potential to be extended to other hospital specialties in the UK and also internationally to other health systems that have comparable national databases of patient-safety incidents.
PMCID: PMC3840344  PMID: 24270831
3.  Global Research Priorities to Better Understand the Burden of Iatrogenic Harm in Primary Care: An International Delphi Exercise 
PLoS Medicine  2013;10(11):e1001554.
Using a modified Delphi exercise, Aziz Sheikh and colleagues identify research priorities for patient safety research in primary care contexts.
Please see later in the article for the Editors' Summary
PMCID: PMC3833831  PMID: 24260028
4.  How Asking Patients a Simple Question Enhances Care at the Bedside: Medical Students as Agents of Quality Improvement 
The Permanente Journal  2013;17(4):27-31.
Medical students have traditionally played a passive role in the delivery of health care. The Institute for Healthcare Improvement Open School members and leaders initiated the Ask One Question project in December 2011. Through a commitment to the project, students are learning to assume a unique position in health care settings, as both learners and caregivers. They are improving care at the bedside by asking a simple question: “How can I improve your stay today?” Using the Model for Improvement to adapt the Ask One Question concept for local use, medical students at Cardiff University (United Kingdom) asked 120 patients. A content analysis of those responses identified 89 issues across 4 broad areas for improvement, including communication issues (uncertainty about their care management and desire for more time with their health care professional); practical issues (assistance with tasks made difficult because of ill health); wider organizational and National Health Services requests; and medical needs (requiring medical or nursing intervention). A medical student, a clinical colleague, or the hospital organization could act on those issues. Actions ranged from attending to simple tasks (eg, finding spectacles) or basic care needs (eg, giving a drink) to suggestions requiring wider institutional change. On a simple but effective level, Ask One Question reflects good manners and is a demonstrable competency of patient-centered practice. It is a vehicle for enabling students to seek improvements in health care and initiate relevant actions to improve the patient experience at the bedside.
PMCID: PMC3854805  PMID: 24361017
5.  The Combined Influence of Distance and Neighbourhood Deprivation on Emergency Department Attendance in a Large English Population: A Retrospective Database Study 
PLoS ONE  2013;8(7):e67943.
The frequency of visits to Emergency Departments (ED) varies greatly between populations. This may reflect variation in patient behaviour, need, accessibility, and service configuration as well as the complex interactions between these factors. This study investigates the relationship between distance, socio-economic deprivation, and proximity to an alternative care setting (a Minor Injuries Unit (MIU)), with particular attention to the interaction between distance and deprivation. It is set in a population of approximately 5.4 million living in central England, which is highly heterogeneous in terms of ethnicity, socio-economics, and distance to hospital. The study data set captured 1,413,363 ED visits made by residents of the region to National Health Service (NHS) hospitals during the financial year 2007/8. Our units of analysis were small units of census geography having an average population of 1,545. Separate regression models were made for children and adults. For each additional kilometre of distance from a hospital, predicted child attendances fell by 2.2% (1.7%–2.6% p<0.001) and predicted adult attendances fell by 1.5% (1.2% –1.8%, p<0.001). Compared to the least deprived quintile, attendances in the most deprived quintile more than doubled for children (incident rate ratio (IRR)  = 2.19, (1.90–2.54, p<0.001)) and adults (IRR 2.26, (2.01–2.55, p<0.001)). Proximity of an MIU was significant and both adult and child attendances were greater in populations who lived further away from them, suggesting that MIUs may reduce ED demand. The interaction between distance and deprivation was significant. Attendance in deprived neighbourhoods reduces with distance to a greater degree than in less deprived ones for both adults and children. In conclusion, ED use is related to both deprivation and distance, but the effect of distance is modified by deprivation.
PMCID: PMC3712987  PMID: 23874473
6.  Index Blood Tests and National Early Warning Scores within 24 Hours of Emergency Admission Can Predict the Risk of In-Hospital Mortality: A Model Development and Validation Study 
PLoS ONE  2013;8(5):e64340.
We explored the use of routine blood tests and national early warning scores (NEWS) reported within ±24 hours of admission to predict in-hospital mortality in emergency admissions, using empirical decision Tree models because they are intuitive and may ultimately be used to support clinical decision making.
A retrospective analysis of adult emergency admissions to a large acute hospital during April 2009 to March 2010 in the West Midlands, England, with a full set of index blood tests results (albumin, creatinine, haemoglobin, potassium, sodium, urea, white cell count and an index NEWS undertaken within ±24 hours of admission). We developed a Tree model by randomly splitting the admissions into a training (50%) and validation dataset (50%) and assessed its accuracy using the concordance (c-) statistic. Emergency admissions (about 30%) did not have a full set of index blood tests and/or NEWS and so were not included in our analysis.
There were 23248 emergency admissions with a full set of blood tests and NEWS with an in-hospital mortality of 5.69%. The Tree model identified age, NEWS, albumin, sodium, white cell count and urea as significant (p<0.001) predictors of death, which described 17 homogeneous subgroups of admissions with mortality ranging from 0.2% to 60%. The c-statistic for the training model was 0.864 (95%CI 0.852 to 0.87) and when applied to the testing data set this was 0.853 (95%CI 0.840 to 0.866).
An easy to interpret validated risk adjustment Tree model using blood test and NEWS taken within ±24 hours of admission provides good discrimination and offers a novel approach to risk adjustment which may potentially support clinical decision making. Given the nature of the clinical data, the results are likely to be generalisable but further research is required to investigate this promising approach.
PMCID: PMC3667137  PMID: 23734195
7.  Patient safety in orthopedic surgery: prioritizing key areas of iatrogenic harm through an analysis of 48,095 incidents reported to a national database of errors 
With scientific and technological advances, the practice of orthopedic surgery has transformed the lives of millions worldwide. Such successes however have a downside; not only is the provision of comprehensive orthopedic care becoming a fiscal challenge to policy-makers and funders, concerns are also being raised about the extent of the associated iatrogenic harm. The National Reporting and Learning System (NRLS) in England and Wales is an underused resource which collects intelligence from reports about health care error.
Using methods akin to case-control methodology, we have identified a method of prioritizing the areas of a national database of errors that have the greatest propensity for harm. Our findings are presented using odds ratios (ORs) and 95% confidence intervals (CIs).
The largest proportion of surgical patient safety incidents reported to the NRLS was from the trauma and orthopedics specialty, 48,095/163,595 (29.4%). Of those, 14,482/48,095 (30.1%) resulted in iatrogenic harm to the patient and 71/48,095 (0.15%) resulted in death. The leading types of errors associated with harm involved the implementation of care and on-going monitoring (OR 5.94, 95% CI 5.53, 6.38); self-harming behavior of patients in hospitals (OR 2.14, 95% CI 1.45, 3.18); and infection control (OR 1.91, 95% CI 1.69, 2.17). We analyze these data to quantify the extent and type of iatrogenic harm in the specialty, and make suggestions on the way forward.
Conclusion and level of evidence
Despite the limitations of such analyses, it is clear that there are many proven interventions which can improve patient safety and need to be implemented. Avoidable errors must be prevented, lest we be accused of contravening our fundamental duty of primum non nocere. This is a level III evidence-based study.
PMCID: PMC3615848  PMID: 23569398
orthopedic surgery; patient safety incident; iatrogenic harm; error
8.  A Simple Insightful Approach to Investigating a Hospital Standardised Mortality Ratio: An Illustrative Case-Study 
PLoS ONE  2013;8(3):e57845.
Despite methodological concerns Hospital Standardised Mortality Ratios (HSMRs) are promoted as measures of performance. Hospitals that experience an increase in their HSMR are presented with a serious challenge but with little guidance on how to investigate this complex phenomenon. We illustrate a simple penetrating approach.
Retrospective analysis of routinely collected hospital admissions data comparing observed and expected deaths predicted by the Dr Foster Unit case mix adjustment method over three years (n = 74,860 admissions) in Shropshire and Telford NHS Trust Hospital (SaTH) constituting PRH (Princess Royal Hospital) and RSH (Royal Shrewsbury Hospital); whose HSMR increased from 99 in the year 2008/09 to 118 in the year 2009/10.
The step up in HSMR was primarily located in PRH (109 to 130 vs. 105 to 118 RSH). Disentangling the HSMR by plotting run charts of observed and expected deaths showed that observed deaths were stable in RSH and PRH but expected deaths, especially at PRH, had fallen. The fall in expected deaths has two possible explanations–genuinely lower risk admissions or that the case-mix adjustment model is underestimating the risk of admissions perhaps because of inadequate clinical coding. There was no evidence that the case-mix profile of admissions had changed but there was considerable evidence that clinical coding process at PRH was producing a lower depth of coding resulting in lower expected mortality.
Knowing whether the change (increase/decrease) in HSMR is driven by the numerator or the denominator is a crucial pivotal first step in understanding a given HSMR and so such information should be an integral part of the HSMR reporting methodology.
PMCID: PMC3589454  PMID: 23472111
9.  Decline in new drug launches: myth or reality? Retrospective observational study using 30 years of data from the UK 
BMJ Open  2013;3(2):e002088.
To describe trends in new drugs launched in the UK from 1982 to 2011 and test the hypothesis that the rate of new drug introductions has declined over the study period. There is wide concern that pharmaceutical innovation is declining. Reported trends suggest that fewer new drugs have been launched over recent decades, despite increasing investment into research and development.
Retrospective observational study.
Setting and data source
Database of new preparations added annually to the British National Formulary (BNF).
Main outcome measures
The number of new drugs entered each year, including new chemical entities(NCEs) and new biological drugs, based on first appearance in the BNF.
There was no significant linear trend in the number of new drugs introduced into the UK from 1982 to 2011. Following a dip in the mid-1980s (11–12 NCEs/new biologics introduced annually from 1985 to 1987), there was a variable increase in the numbers of new drugs introduced annually to a peak of 34 in 1997. This peak was followed by a decline to approximately 20 new drugs/year between 2003 and 2006, and another peak in 2010. Extending the timeline further back with existing published data shows an overall slight increase in new drug introductions of 0.16/year over the entire 1971 to 2011 period.
The purported ‘innovation dip’ is an artefact of the time periods previously studied. Reports of declining innovation need to be considered in the context of their timescale and perspective.
PMCID: PMC3585972  PMID: 23427198
Innovation; Pharmaceutical; New drugs; Drug launches; United Kingdom
10.  Mortality as an indicator of patient safety in orthopaedics: lessons from qualitative analysis of a database of medical errors 
Orthopaedic surgery is a high-risk specialty in which errors will undoubtedly occur. Patient safety incidents can yield valuable information to generate solutions and prevent future cases of avoidable harm. The aim of this study was to understand the causative factors leading to all unnecessary deaths in orthopaedics and trauma surgery reported to the National Patient Safety Agency (NPSA) over a four-year period (2005–2009), using a qualitative approach.
Reports made to the NPSA are categorised and stored in the database as free-text data. A search was undertaken to identify the cases of all-cause mortality in orthopaedic and trauma surgery, and the free-text elements were used for thematic analysis. Descriptive statistics were calculated based on the incidents reported. This included presenting the number of times categories of incidents had the same or similar response. Superordinate and subordinate categories were created.
A total of 257 incident reports were analysed. Four main thematic categories emerged. These were: (1) stages of the surgical journey – 118/191 (62%) of deaths occurred in the post-operative phase; (2) causes of patient deaths – 32% were related to severe infections; (3) reported quality of medical interventions – 65% of patients experienced minimal or delayed treatment; (4) skills of healthcare professionals – 44% of deaths had a failure in non-technical skills.
Most complications in orthopaedic surgery can be dealt with adequately, provided they are anticipated and that risk-reduction strategies are instituted. Surgeons take pride in the precision of operative techniques; perhaps it is time to enshrine the multimodal tools available to ensure safer patient care.
PMCID: PMC3416713  PMID: 22682470
Patient safety; Errors; Orthopaedics; Trauma surgery; Quality improvement
11.  Weekend admission to hospital has a higher risk of death in the elective setting than in the emergency setting: a retrospective database study of national health service hospitals in England 
Although acute hospitals offer a twenty-four hour seven day a week service levels of staffing are lower over the weekends and some health care processes may be less readily available over the weekend. Whilst it is thought that emergency admission to hospital on the weekend is associated with an increased risk of death, the extent to which this applies to elective admissions is less well known. We investigated the risk of death in elective and elective patients admitted over the weekend versus the weekdays.
Retrospective statistical analysis of routinely collected acute hospital admissions in England, involving all patient discharges from all acute hospitals in England over a year (April 2008-March 2009), using a logistic regression model which adjusted for a range of patient case-mix variables, seasonality and admission over a weekend separately for elective and emergency (but excluding zero day stay emergency admissions discharged alive) admissions.
Of the 1,535,267 elective admissions, 91.7% (1,407,705) were admitted on the weekday and 8.3% (127,562) were admitted on the weekend. The mortality following weekday admission was 0.52% (7,276/1,407,705) compared with 0.77% (986/127,562) following weekend admission. Of the 3,105,249 emergency admissions, 76.3% (2,369,316) were admitted on the weekday and 23.7% (735,933) were admitted on the weekend. The mortality following emergency weekday admission was 6.53% (154,761/2,369,316) compared to 7.06% (51,922/735,933) following weekend admission. After case-mix adjustment, weekend admissions were associated with an increased risk of death, especially in the elective setting (elective Odds Ratio: 1.32, 95% Confidence Interval 1.23 to 1.41); vs emergency Odds Ratio: 1.09, 95% Confidence Interval 1.05 to 1.13).
Weekend admission appears to be an independent risk factor for dying in hospital and this risk is more pronounced in the elective setting. Given the planned nature of elective admissions, as opposed to the unplanned nature of emergency admissions, it would seem less likely that this increased risk in the elective setting is attributable to unobserved patient risk factors. Further work to understand the relationship between weekend processes of care and mortality, especially in the elective setting, is required.
PMCID: PMC3341193  PMID: 22471933
12.  Minimising drug errors in critically ill patients 
Critical Care  2011;15(1):401.
PMCID: PMC3222016  PMID: 21235830
13.  The value of administrative databases 
BMJ : British Medical Journal  2007;334(7602):1014-1015.
Is improving but their contribution to improving quality of care remains unclear
PMCID: PMC1871738  PMID: 17510106
14.  A randomized trial of the addition of home-based exercise to specialist heart failure nurse care: the Birmingham Rehabilitation Uptake Maximisation study for patients with Congestive Heart Failure (BRUM-CHF) study 
European Journal of Heart Failure  2009;11(2):205-213.
Supervised exercise can benefit selected patients with heart failure, however the effectiveness of home-based exercise remains uncertain. We aimed to assess the effectiveness of a home-based exercise programme in addition to specialist heart failure nurse care.
Methods and results
This was a randomized controlled trial of a home-based walking and resistance exercise programme plus specialist nurse care (n = 84) compared with specialist nurse care alone (n = 85) in a heart failure population in the West Midlands, UK. Primary outcome: Minnesota Living with Heart Failure Questionnaire (MLwHFQ) at 6 and 12 months. Secondary outcomes: composite of death, hospital admission with heart failure or myocardial infarction; psychological well-being; generic quality of life (EQ-5D); exercise capacity. There was no statistically significant difference between groups in the MLwHFQ at 6 month (mean, 95% CI) (−2.53, −7.87 to 2.80) and 12 month (−0.55, −5.87 to 4.76) follow-up or secondary outcomes with the exception of a higher EQ-5D score (0.11, 0.04 to 0.18) at 6 months and lower Hospital Anxiety and Depression Scale score (−1.07, −2.00 to −0.14) at 12 months, in favour of the exercise group. At 6 months, the control group showed deterioration in physical activity, exercise capacity, and generic quality of life.
Home-based exercise training programmes may not be appropriate for community-based heart failure patients.
PMCID: PMC2639417  PMID: 19168520
Heart failure; Exercise therapy; Randomized controlled trial
15.  Fluorescence Correlation Spectroscopy Reveals Biophysical Structure of Lung Endothelial Glycocalyx: The Canopy Model 
The endothelial glycocalyx is believed to play a major role in capillary permeability by functioning as a macromolecular sieve overlying the intercellular junction. Little is known about the three-dimensional organization of the glycocalyx, nor which constituents contribute to its overall structure-function relationship. We applied fluorescence correlation spectroscopy (FCS) to evaluate albumin diffusion and concentration profiles directly within the glycocalyx overlying the intercellular junctions of lung capillary endothelial cells. FCS data were obtained before and after enzymatic digestion of the glycocalyx with pronase, heparinase, or hyaluronidase. FCS revealed a structure interacting with albumin located from 1.0 to 2.0 μm above the cell membrane; this structure was capable of reducing albumin diffusion by 30% and increasing local albumin concentration by 5-fold. Digestion of the glycocalyx with pronase or heparinase resulted in only modest changes of albumin diffusion and concentration. Hyaluronidase digestion completely eliminated albumin-glycocalyx interactions. Based on these data, the biophysical structure of lung capillary glycocalyx appears like a dense canopy approximately 1.0 μm in thickness located well above the cell surface. These data also suggest that hyaluronan is a major determinant for albumin interactions with the lung endothelial glycocalyx structure. Confocal images of heparan sulfate and hyaluronan confirm a cell-surface layer 2-3 μm in thickness, thus validating FCS-derived measurements. In summary, we have used FCS to probe the extra-cellular structure of the endothelial glycocalyx and further our understanding of the structure-function relationship.
PMCID: PMC2741179  PMID: 17483194
endothelial cells; glycocalyx; lung; fluoresence correlation spectroscopy
16.  Comparison of direct and indirect methods of estimating health state utilities for resource allocation: review and empirical analysis 
Background and objective Utilities (values representing preferences) for healthcare priority setting are typically obtained indirectly by asking patients to fill in a quality of life questionnaire and then converting the results to a utility using population values. We compared such utilities with those obtained directly from patients or the public.
Design Review of studies providing both a direct and indirect utility estimate.
Selection criteria Papers reporting comparisons of utilities obtained directly (standard gamble or time trade off) or indirectly (European quality of life 5D [EQ-5D], short form 6D [SF-6D], or health utilities index [HUI]) from the same patient.
Data sources PubMed and Tufts database of utilities.
Statistical methods Sign test for paired comparisons between direct and indirect utilities; least squares regression to describe average relations between the different methods.
Main outcome measures Mean utility scores (or median if means unavailable) for each method, and differences in mean (median) scores between direct and indirect methods.
Results We found 32 studies yielding 83 instances where direct and indirect methods could be compared for health states experienced by adults. The direct methods used were standard gamble in 57 cases and time trade off in 60 (34 used both); the indirect methods were EQ-5D (67 cases), SF-6D (13), HUI-2 (5), and HUI-3 (37). Mean utility values were 0.81 (standard gamble) and 0.77 (time trade off) for the direct methods; for the indirect methods: 0.59 (EQ-5D), 0.63 (SF-6D), 0.75 (HUI-2) and 0.68 (HUI-3).
Discussion Direct methods of estimating utilities tend to result in higher health ratings than the more widely used indirect methods, and the difference can be substantial. Use of indirect methods could have important implications for decisions about resource allocation: for example, non-lifesaving treatments are relatively more favoured in comparison with lifesaving interventions than when using direct methods.
PMCID: PMC2714630  PMID: 19729421
17.  Evidence of methodological bias in hospital standardised mortality ratios: retrospective database study of English hospitals 
Objective To assess the validity of case mix adjustment methods used to derive standardised mortality ratios for hospitals, by examining the consistency of relations between risk factors and mortality across hospitals.
Design Retrospective analysis of routinely collected hospital data comparing observed deaths with deaths predicted by the Dr Foster Unit case mix method.
Setting Four acute National Health Service hospitals in the West Midlands (England) with case mix adjusted standardised mortality ratios ranging from 88 to 140.
Participants 96 948 (April 2005 to March 2006), 126 695 (April 2006 to March 2007), and 62 639 (April to October 2007) admissions to the four hospitals.
Main outcome measures Presence of large interaction effects between case mix variable and hospital in a logistic regression model indicating non-constant risk relations, and plausible mechanisms that could give rise to these effects.
Results Large significant (P≤0.0001) interaction effects were seen with several case mix adjustment variables. For two of these variables—the Charlson (comorbidity) index and emergency admission—interaction effects could be explained credibly by differences in clinical coding and admission practices across hospitals.
Conclusions The Dr Foster Unit hospital standardised mortality ratio is derived from an internationally adopted/adapted method, which uses at least two variables (the Charlson comorbidity index and emergency admission) that are unsafe for case mix adjustment because their inclusion may actually increase the very bias that case mix adjustment is intended to reduce. Claims that variations in hospital standardised mortality ratios from Dr Foster Unit reflect differences in quality of care are less than credible.
PMCID: PMC2659855  PMID: 19297447
18.  Home-based exercise rehabilitation in addition to specialist heart failure nurse care: design, rationale and recruitment to the Birmingham Rehabilitation Uptake Maximisation study for patients with congestive heart failure (BRUM-CHF): a randomised controlled trial 
Exercise has been shown to be beneficial for selected patients with heart failure, but questions remain over its effectiveness, cost-effectiveness and uptake in a real world setting. This paper describes the design, rationale and recruitment for a randomised controlled trial that will explore the effectiveness and uptake of a predominantly home-based exercise rehabilitation programme, as well as its cost-effectiveness and patient acceptability.
Randomised controlled trial comparing specialist heart failure nurse care plus a nurse-led predominantly home-based exercise intervention against specialist heart failure nurse care alone in a multiethnic city population, served by two NHS Trusts and one primary care setting, in the United Kingdom.
169 English speaking patients with stable heart failure, defined as systolic impairment (ejection fraction ≤ 40%). with one or more hospital admissions with clinical heart failure or New York Heart Association (NYHA) II/III within previous 24-months were recruited.
Main outcome measures at 1 year: Minnesota Living with Heart Failure Questionnaire, incremental shuttle walk test, death or admission with heart failure or myocardial infarction, health care utilisation and costs. Interviews with purposive samples of patients to gain qualitative information about acceptability and adherence to exercise, views about their treatment, self-management of their heart failure and reasons why some patients declined to participate.
The records of 1639 patients managed by specialist heart failure services were screened, of which 997 (61%) were ineligible, due to ejection fraction>40%, current NYHA IV, no admission or NYHA II or more within the previous 2 years, or serious co-morbidities preventing physical activity. 642 patients were contacted: 289 (45%) declined to participate, 183 (39%) had an exclusion criterion and 169 (26%) agreed to randomisation.
Due to safety considerations for home-exercise less than half of patients treated by specialist heart failure services were eligible for the study. Many patients had co-morbidities preventing exercise and others had concerns about undertaking an exercise programme.
PMCID: PMC1821338  PMID: 17343738
19.  Admissions processes for five year medical courses at English schools: review 
BMJ : British Medical Journal  2006;332(7548):1005-1009.
Objective To describe the current methods used by English medical schools to identify prospective medical students for admission to the five year degree course.
Design Review study including documentary analysis and interviews with admissions tutors.
Setting All schools (n = 22) participating in the national expansion of medical schools programme in England.
Results Though there is some commonality across schools with regard to the criteria used to select future students (academic ability coupled with a “well rounded” personality demonstrated by motivation for medicine, extracurricular interests, and experience of team working and leadership skills) the processes used vary substantially. Some schools do not interview; some shortlist for interview only on predicted academic performance while those that shortlist on a wider range of non-academic criteria use various techniques and tools to do so. Some schools use information presented in the candidate's personal statement and referee's report while others ignore this because of concerns over bias. A few schools seek additional information from supplementary questionnaires filled in by the candidates. Once students are shortlisted, interviews vary in terms of length, panel composition, structure, content, and scoring methods.
Conclusion The stated criteria for admission to medical school show commonality. Universities differ greatly, however, in how they apply these criteria and in the methods used to select students. Different approaches to admissions should be developed and tested.
PMCID: PMC1450044  PMID: 16543300
20.  Adjusting for treatment refusal in rationing decisions 
BMJ : British Medical Journal  2006;332(7540):542-544.
Assessments of cost effectiveness are increasingly used to get the most value from limited health resources. Could adjusting for people who wouldn't want the treatment improve the process?
PMCID: PMC1388139  PMID: 16513714
21.  Recruitment of ethnic minority patients to a cardiac rehabilitation trial: The Birmingham Rehabilitation Uptake Maximisation (BRUM) study [ISRCTN72884263] 
Concerns have been raised about low participation rates of people from minority ethnic groups in clinical trials. However, the evidence is unclear as many studies do not report the ethnicity of participants and there is insufficient information about the reasons for ineligibility by ethnic group. Where there are data, there remains the key question as to whether ethnic minorities more likely to be ineligible (e.g. due to language) or decline to participate. We have addressed these questions in relation to the Birmingham Rehabilitation Uptake Maximisation (BRUM) study, a randomized controlled trial (RCT) comparing a home-based with a hospital-based cardiac rehabilitation programme in a multi-ethnic population in the UK.
Analysis of the ethnicity, age and sex of presenting and recruited subjects for a trial of cardiac rehabilitation in the West-Midlands, UK.
Participants: 1997 patients presenting post-myocardial infarction, percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery.
Data collected: exclusion rates, reasons for exclusion and reasons for declining to participate in the trial by ethnic group.
Significantly more patients of South Asian ethnicity were excluded (52% of 'South Asian' v 36% 'White European' and 36% 'Other', p < 0.001). This difference in eligibility was primarily due to exclusion on the basis of language (i.e. the inability to speak English or Punjabi). Of those eligible, similar proportions were recruited from the different ethnic groups (white, South Asian and other). There was a marked difference in eligibility between people of Indian, Pakistani or Bangladeshi origin.
Once eligible for this trial, people from different ethnic groups were recruited in similar proportions. The reason for ineligibility in the BRUM study was the inability to support the range of minority languages.
PMCID: PMC1166559  PMID: 15904499
22.  An investigation into general practitioners associated with high patient mortality flagged up through the Shipman inquiry: retrospective analysis of routine data 
BMJ : British Medical Journal  2004;328(7454):1474-1477.
Objective To identify a credible explanation for the excessively high mortality associated with general practitioners who were flagged up by the Shipman inquiry.
Design Retrospective analysis of routine data.
Setting Primary care.
Participants Two general practitioners in the West Midlands who were associated with an unacceptably high mortality of patients during 1993-2000.
Main outcome measures Observed and expected number of deaths and deaths in nursing homes.
Results Preliminary discussions with the general practitioners highlighted deaths in nursing homes as a possible explanatory factor. No relation was found between the expected number of deaths and deaths in nursing homes in each year during 1993-2000 for either general practitioner. In contrast, the magnitude and shape of the curves of a cumulative sum plot for excess number of deaths (observed minus expected) in each year were closely mirrored by the magnitude and shape of the curves of the number of patients dying in nursing homes; and this was reflected in the high correlations (R2 = 0.87 and 0.89) between excess mortality and the number of deaths in nursing homes in each year for the general practitioners. These findings were supported by administrative data.
Conclusions The excessively high mortality associated with two general practitioners was credibly explained by a nursing home effect. General practitioners associated with high patient mortality, albeit after sophisticated statistical analysis, should not be labelled as having poor performance but instead should be considered as a signal meriting scientific investigation.
PMCID: PMC428518  PMID: 15205291

Results 1-25 (27)