North Staffordshire Hospital Research Articles

Charles Henry James Swan

Charles Henry James Swan was born in Wolverhampton and educated at Wolverhampton Grammar School. During training in the West Midlands, he obtained an MD from Birmingham University and then spent...

The Stoke CNEP Saga – how it damaged all involved

After one family made allegations about the way the study of an innovative strategy for providing nursing care was conducted, staff in the neonatal unit at North Staffordshire Hospital endured 11 years of disciplinary enquiry. And, because staff are barred from talking while under investigation, it has only recently become possible to describe in detail much of what then went on.

The CNEP trial: how a good trial was turned rotten

The CNEP trial: how a good trial was turned rotten

Frequency of nocturnal hypoxia in clinically stable patients during stroke rehabilitation

Objective: Sleep disordered breathing is common in patients with cerebrovascular disease. Nocturnal hypoxia may lead to daytime tiredness and cognitive impairment, thus affecting progress. This study assessed the prevalence of nocturnal hypoxia during rehabilitation from stroke. Design: Prospective observational trial. Setting: The stroke rehabilitation wards of the North Staffordshire Hospital, UK and of Kreiskrankenhaus Grevenbroich, Germany. Subjects: Adult patients on a stroke rehabilitation ward, 10 days to 3 months (mean 32 days, SD18) after stroke onset (n = 160). Age and local environment-matched controls (n = 156) without a history of stroke were recruited from the community at both centres. Main measures: Pulse oximetry was performed overnight on the day of enrolment from 21:00 to 09:00. The baseline awake oxygen saturation, the mean nocturnal oxygen saturation, the lowest nocturnal oxygen saturation and the 4% Oxygen Desaturation Index were calculated for each participant. Results: The mean baseline awake oxygen saturation of stroke patients was at 95.3% (SD 1.7), 0.5% lower than that of controls (P = 0.005, independent t-test). The group means of the mean nocturnal oxygen saturation for stroke patients were 0.5% lower (at 93.8% SD 2.2) than controls (P = 0.03, independent t-test). The mean lowest nocturnal oxygen saturation was at 79.4% (SD 9.9), 5.9% lower than that of the controls (P<0.001, independent t-test). Considerably more stroke patients (n = 67, 42%) than controls (n = 24, 15%) had ≥10 desaturations below the baseline per hour (P<0.001 chi-square test). Conclusion: Clinically stable stroke patients enrolled in rehabilitation programmes have lower oxygen saturation and more nocturnal desaturations than non-stroke controls.

The 1996 Continuous Negative Extrathoracic Pressure (CNEP) Trial: Were Parents' Allegations of Research Fraud Fraudulent?

Pediatricians in Britain have been watching with increasing incredulity the convoluted and dysfunctional way that their regulatory authorities have investigated allegations that fraud occurred during the conduct of a randomized, controlled trial reported in Pediatrics in December 1996.1 The study under scrutiny took place at Queen Charlotte's Hospital (London, United Kingdom) and the North Staffordshire Hospital (Stoke on Trent, United Kingdom). It was designed to determine whether the use of continuous negative extrathoracic pressure (CNEP) reduced the number of preterm infants with respiratory failure needing tracheal intubation, the length of time they needed intubation, and the time it took for them to be weaned from supplementary oxygen. It reported a marginal but statistically significant improvement in early respiratory outcomes and an even more marginal, nonsignificant increase in the number of infants in the CNEP group who did not survive to discharge. However, at least 1 family lodged a formal complaint over the way the trial had been conducted 5 months after the research article appeared, and even today, 9 years later, the issues raised by that complaint still remain unresolved. The proper conduct of clinical research, and the proper conduct of investigations into allegations of research misconduct, are rightly issues of concern to clinicians everywhere. It is worth recounting, therefore, what went wrong with the investigation of those allegations by the United Kingdom's various regulatory authorities. The initial complaint was widely reported. Indeed, 1 early headline in a national Sunday article read “Parents say ‘guinea pig’ trial killed their babies,”2 and headlines like this soon attracted the attention of a small but very active and well-organized pressure group3 that was already extremely hostile to the work of Professor David Southall, one of the principal instigators of the CNEP trial. The hostility stemmed from his use of covert … Address correspondence to Edmund Hey, DM. E-mail: shey{at}easynet.co.uk

Are any of the criticisms of the CNEP trial true?

Those who saw this banner headline on the front page of The Independent on Monday, May 8, 2000, 1 Laurance J Parents were misled over hospital trials that killed premature babies. Independent (London). May 8, 2000; : 1 Google Scholar could be forgiven for thinking that something had gone seriously wrong with clinical research in the UK, and with the oversight of neonatal research in particular. The story was triggered by a Government inquiry into clinical research done in Stoke-on-Trent. 2 NHS Executive West Midlands Regional OfficeReport of a review of the research framework in North Staffordshire Hospital NHS Trust. Leeds: NHS Executive. http://www.dh.gov.uk/assetRoot/04/01/45/42/04014542.pdfDate: 2000 Google Scholar Richard Smith, Editor of the BMJ, was in no doubt at the time that “yet another NHS [UK National Health Service] scandal” had been uncovered. 3 Smith R Babies and consent: yet another NHS scandal. BMJ. 2000; 320: 1285-1286 Crossref PubMed Scopus (19) Google Scholar “At best”, he wrote, “the episode will lead to an overdue improvement in research practice throughout the NHS. At worst, it will further undermine public confidence in the NHS and doctors, and lead to a proliferation of bureaucracy that will increase the difficulties of doing research.” Southall's CNEP trial more than stands up to scrutinyIn the late 1990s, the UK Department of Health asked Rod Griffiths to investigate whether David Southall, Martin Samuels, and their colleagues had done a clinical trial in newborn infants with respiratory distress syndrome according to best practice. Some parents had alleged that the trial was poorly supervised and that they had not given informed consent for their children to be enrolled in the study, which compared continuous negative extrathoracic-pressure ventilation (CNEP) with standard treatment. Full-Text PDF CNEP needs to returnWe welcome the findings of the study by Katherine Telford and colleagues1 in today's Lancet about the absence of evidence of harm to the long-term neurodevelopmental outcome of preterm infants treated with continuous negative extrathoracic pressure (CNEP) in our randomised trial. Support for babies and young children with respiratory failure is usually achieved by intubation and positive pressure ventilation. However, this approach can damage the immature lung, increases the risk for secondary infection, and needs analgesia or sedation. Full-Text PDF Southall and colleagues vindicated once moreThe pioneering research of David Southall and colleagues1–4 has been subjected to unprecedented scrutiny. Southall's work has often been at the cutting edge of knowledge and he has ventured into areas that are inherently controversial. He has made many important contributions to the published literature and many lives have undoubtedly been saved by his research. Full-Text PDF CNEP and research governanceRepeated headlines about baby deaths associated with experimental treatment—continuous negative extrathoracic pressure (CNEP)—attracted the attention of Members of Parliament. Their pressure on Ministers led to the question, “Could there be a problem with the system?” and this led to the review1 I chaired. Matters were further complicated when groups of parents insisted on child protection issues being considered, but they have no place here. Full-Text PDF Outcome after neonatal continuous negative-pressure ventilation: follow-up assessmentWe saw no evidence of poorer long-term outcome after neonatal CNEP whether analysis was by original pairing or by unpaired comparisons, despite small differences in adverse neonatal outcomes. The experience of our study indicates that future studies of neonatal interventions with the potential to influence later morbidity should be designed with longer-term outcomes in mind. Full-Text PDF

Longitudinal trends in trauma mortality and survival in Stoke-on-Trent 1992–1998

Objectives: To identify factors related to mortality and to test the null hypothesis of no longitudinal trend in mortality in patients admitted to the North Staffordshire Hospital (NSH) with an Injury Severity Score (ISS) greater than 15, between April 1992 and March 1998. Design: Longitudinal prospective study of 18 factors, including age, sex, mechanism of injury, anatomical injury scores and year of admission. Outcome, based on mortality at discharge, was analysed in two ways: alive or dead at discharge (mortality) and time to death or discharge (survival). Results: A decreasing trend ( P<0.01) in mortality with year of admission was detected on the log-odds scale. The trend could not be explained by a case-mix analysis, which allowed for the 17 other factors. Using multiple logistic regression analysis (mortality) and Cox proportional hazards analysis (survival), eight factors were identified as determinants of outcome: age, head AIS score, chest AIS score, abdominal AIS score, calendar year of admission, external injury AIS score, mechanism of the injury and primary receiving hospital. Conclusions: The observed improvement in survival in severely injured patients must result from the interplay of factors not controlled in this analysis or improvements in patient care or both.

Use of botulinum toxin type A in management of adult spasticity--a European consensus statement.

Anthony B. Ward, Miguel Aguilar, Zegers De Beyl, Susanne Gedin, Petr Kanovsky, Franco Molteni, Jorg Wissel and Anton Yakovleff From the Department of Rehabilitation Medicine, North Staffordshire Hospital, Stoke-on Trent, UK, Department of Neurology, Hospital Mutua Terrassa, Barcelona, Spain, Department of Neurology, Hopital Erasme, Universite Libre de Bruxelles, Belgium, Department of Neurology, Helsingborg Hospital, Sweden, Department of Neurology, Masaryk University, Brno, Czech Republic, Movement Disorders Rehabilitation Unit, Valduce Rehabilitation Centre, Costa Masnaga, Lecco, Italy, Department of Neurology, Clinic for Neurorehabilitation, Beelitz-Heilstatten, Germany, Clinical Neurology, Universite de Paris V-Rene Descartes, France

International Trauma Anesthesia and Critical Care Society (ITACCS).

International Trauma Anesthesia and Critical Care Society (ITACCS).

Providing continuity of care in high-risk patients

Further to an audit in 1990, this project aimed to improve the specialised training of midwives at North Staffordshire Hospital to facilitate the achievement of targets set within the guidelines for management of severe preeclampsia. Fifteen midwives received ‘high-risk care’ training. After completion of training, the quality of care given to patients was examined by reviewing patient notes. Despite numerous staffing changes, 85% were looked after by a ‘high dependency’ trained midwife. Appropriate monitoring and fluid management improved significantly. The proportion cared for by five or more decision makers remained high, although there were no significant differences between the three audits. Input from a specialist team was sought in 28% of cases, significantly less than in 1994, however 85% were seen by a consultant obstetrician. It is evident that the training improved the quality of care and monitoring, with minimal adverse incidents. In addition, the majority of patients were looked after at some point by a midwife with enhanced skills and a greater knowledge of high dependency care.

A randomised controlled trial to compare methods of milk expression after preterm delivery

OBJECTIVESPrimary: to compare sequential and simultaneous breast pumping on volume of milk expressed and its fat content. Secondary: to measure the effect of breast massage on milk volume and fat...

Caesarean section by choice could fulfil the inverse care law

We have assessed knowledge about caesarean sections in a group of North Staffordshire Hospital professionals and patients. Those who were more interested in having a caesarean section without medical indication were the nulliparous health professionals, the majority of whom thought they should be able to choose this option. Paradoxically, this was also the group who were most likely to consider that caesarean section is more expensive and dangerous. The explanation may be that they also felt it to be an easier, less painful and more convenient option.

Parents' understanding of a randomised double-blind controlled trial.

Recent reports in the media about the NHS inquiry at a North Staffordshire hospital have highlighted concerns about clinical trials involving children, especially about informed consent and the information given to parents. An inquiry led by Professor Griffiths has recommended that the Department of Health produce guidelines for the conduct of clinical trials (Boseley 2000, Rumbelow and Johnstone 2000). The UKCC Code of Professional Conduct (1992) requires that nurses must ‘act always in such a manner to promote and safeguard the interests and well being of patients and clients’. Polit and Hungler (1991) summarise informed consent as meaning ‘subjects have adequate information regarding the research; are capable of comprehending the information and have the power of free choice, enabling them to voluntarily consent to participate in the research or decline participation’. While actively recruiting pre-school children for a randomised controlled trial, the research team became aware that despite adhering to the consent procedure and regular contacts with parents, 14 of the 54 participants failed to complete the trial as requested. Albert and Chadwick (1992) suggest that effective communication can only take place if a message is successfully and completely transferred from one person to another. It was important that the research team (two nurses, a registrar and a consultant) were able to identify and understand any potential communication problems with the information given about the trial. A retrospective postal audit of all 54 participants was carried out to address the question of why some parents failed to complete the trial and if information given to parents should be adapted. The results of this audit will be presented in this article.

A fracture movement monitoring system to aid in the assessment of fracture healing in humans

This paper presents a new design for a device to monitor the motion of fracture fragments in diaphyseal tibial fractures. The device measures the motion that occurs at the fracture site when loaded by gait or by manipulation. It has undergone rigorous calibration and acceptance trials. The device has been used in ethically approved research clinics held at the North Staffordshire Hospital (40 patients). The paper presents a selection of results obtained using the new device. The results demonstrate several new ways of assessing fracture healing by examining fracture site motion. The following conclusions were drawn: 1. If fracture monitoring devices are to be attached to bone screws, it is essential to minimize bone screw errors. To do this, each patient must have similar bone screw lengths, orientations, alignment and siting. This is only achievable using a peroperative reduction device. 2. If fracture stiffness is to be used as a measure of fracture healing, load rate should be controlled; at the very least strain rate should be controlled. 3. It is imperative that fracture stiffness be measured in more than one plane by a biplanar device so that asymmetry may be accommodated. 4. Fracture stiffness, on its own, is probably not a sufficiently rigorous measure of healing end-point. The quantifiably viscoelastic properties of healing callus should be taken into account.

Short-term sequelae of minor head injury (6 years experience of minor head injury clinic)

Purpose : It is known that post-concussive symptoms may persist after mild head injury. However, the majority of those patients are denied follow-up or support. A minor head injury clinic was thus established in North Staffordshire Hospital in 1993 to address these problems. Methods : Patients 16 - 65 years old attending hospital with minor head injury were invited to attend the clinic two weeks after presentation. A specialized brain injury nurse and/or assistant clinical psychologist assessed them. Patients with persistent symptoms were invited to a second assessment four weeks later. Results : One thousand two hundred and fifty-five patients were invited for first assessment, the most common cause of head injury was assault (454) followed by road traffic accident (334). Six hundred and sixteen patients did not attend the first assessment; most of non-attendees were those who had been assaulted (281). Six hundred and thirty-nine patients attended, (472) were male, their mean age was 33. Forty-three per cent of them had history of recent alcohol intake. One third had had a previous head injury. Although 391 attendees were in regular employment, 219 patients were unable to return to work 2 weeks after discharge (56% ), and 49 people were still off sick 6 weeks after the injury. The most common complaints at both assessments were fatigue, headache, dizziness, irritability, sleep disturbances, poor concentration and poor memory in that order. Conclusion : This study shows a significant number of patients with minor head injury still complaining of post concussive symptoms, which may contribute to a delay in return to work. The high incidence of non-attendance among the assaulted victims may indicate that this group needs to be more effectively targeted. Further study to look at the longer-term consequences of minor head injury is required in view of these findings.

A comparison of patient characteristics and survival in two trauma centres located in different countries

Introduction: The aim of the study was to compare patient characteristics and mortality in severely injured patients in two trauma centres located in different countries, allowing for differences in case-mix. It represents a direct bench-marking exercise between the trauma centres at the North Staffordshire Hospital (NSH), Stoke-on-Trent, UK and the Oregon Health Sciences University (OHSU) Hospital, Portland, Oregon, USA. Methods: Patients of all ages admitted to the two hospitals during 1995 and 1996 with an Injury Severity Score >15 were included, except for those who died in the emergency departments. Twenty-three factors were studied, including the Injury Severity Score, Glasgow Coma Score, mechanism of injury and anatomical site of injury. Outcome analysis was based on mortality at discharge. Results: The pattern of trauma differed significantly between Stoke and Portland. Patients from Stoke tended to be older, presented with a lower conscious level and a lower systolic blood pressure and were intubated less frequently before arriving at hospital. Mortality depended on similar factors in both centres, especially age, highest AIS score, systolic blood pressure and Glasgow Coma Score. The crude analysis of mortality showed a highly significant odds-ratio of 1.64 in Stoke compared with Portland. Single-factor adjustments were made for the above four factors, which had a similar influence on mortality in both centres. Adjusting for the first three factors individually did not alter the odds-ratio, which stayed in the range 1.53–1.59 and remained highly significant. Adjusting for the Glasgow Coma Score reduced the odds-ratio to 0.82 and rendered it non-significant. In a multi-factor logistic regression model incorporating all of the factors shown to influence mortality in either centre, the odds-ratio was 1.7 but was not significant. Conclusion: The analysis illustrates the limitations and pitfalls of making crude outcome comparisons between centres. Highly significant differences in crude mortality were rendered non-significant by case-mix adjustments, supporting the null hypothesis that the two centres were equally effective in terms of this short-term indicator of outcome. To achieve a meaningful comparison between centres, adjustments must be made for the factors which affect mortality.

Case in Focus. Mediation: Billington v North Staffordshire Hospital NHS Trust

Case in Focus. Mediation: Billington <i>v</i> North Staffordshire Hospital NHS Trust

Improving the standards of care for women having caesarean sections

Improvement in the uptake of prophylactic antibiotics at caesarean section was chosen as a priority at the 1994 ASQUAM (Achieving Sustainable Quality in Maternity) meeting. The interventions used were guidelines, cyclical audit of cases and a patient-specific reminder stamp in the notes. A more detailed qualitative assessment of standards of communication and outcome was undertaken on a smaller cohort of women. Data on antibiotic prophylaxis were obtained from an audit record completed for every caesarean section undertaken at North Staffordshire Hospital from 1996 to 1998. Information on morbidity following caesarean section and on counselling was obtained from a review of the case records of a consecutive series of 75 caesarean sections and from a telephone call. In the baseline audit, 75% of women had received antibiotics; this increased to 92% in the remainder of 1996, 95% in 1997 and 98% in 1998. Fifty-eight of the 75 women were contactable by telephone (77%); of these 16 (28%) had a 'wound infection', 12 of which developed after discharge from hospital. Only 25 women (43%) remembered being counselled about the caesarean section. It is possible to achieve significant improvements in the quality of care for women having caesarean sections through the use of local guidelines, cyclical audit and reminder stamps. However, this audit, with community follow-up, raises questions about the adequacy of single dose prophylaxis. It also suggests the need for improved compliance with RCOG communication following caesarean section guidelines.

Trauma systems and major injury centres for the 21st century: an option

Trauma, especially involving accidents and falls is now the leading cause of death in the UK in the first four decades of life. This paper looks at the existing pattern of Accident and Emergency Units and suggests that because it has grown up in a fragmented and poorly co-ordinated fashion and because it is subjected to demands that it was not designed for, it is inadequate in dealing with the most severe injury cases. Following collaborative work with researchers at the North Staffordshire Hospital, the authors propose a system of thirty major trauma centres to cover the whole of the UK. Each would deal with the most severe accident cases from surrounding hospitals. Using data from the census and from health authorities, analysed within a GIS environment, a locational pattern for these centres is suggested and their catchment areas are outlined.

Cardiovascular disease and risk factors in adults with hypopituitarism.

In 1992, Cuneo et al. (1992) reviewed, in this journal, the consequences of growth (GH) deficiency during adult life and coined the term ‘Growth hormone deficiency (GHD) syndrome in adults’. Limited information was available then on cardiovascular disease and risk factors in adults with hypopituitarism. More data have been published since on cardiovascular morbidity in symptom-free hypopituitary adults. Several groups have also published results on the effects of GH therapy on cardiac structure and function and on the cardiovascular risk factors. We shall review here the epidemiological and experimental data on cardiovascular morbidity and mortality in adult hypopituitarism. We shall also examine the prevalence of cardiovascular risk factors in this group of patients and their potential causes focusing on the possible role of GH deficiency and the effects of GH replacement.