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1.  A Phase I Multi-Institutional Study of Systemic Sorafenib in Conjunction with Regional Melphalan for In-Transit Melanoma of the Extremity 
Annals of surgical oncology  2012;19(12):3896-3905.
Isolated limb infusion with melphalan (ILIM) corrected for ideal body weight (IBW) is a well-tolerated treatment for patients with in-transit extremity melanoma with an approximate 29 % complete response (CR) rate. Sorafenib, a multi-kinase inhibitor, has been shown to augment tumor response to chemotherapy in preclinical studies.
A multi-institutional, dose-escalation, phase I study was performed to evaluate the safety and antitumor activity of sorafenib in combination with ILI-M. Patients with AJCC stage IIIB/IIIC/IV melanoma were treated with sorafenib starting at 400 mg daily for 7 days before and 7 days after ILI-M corrected for IBW. Toxicity, drug pharmacokinetics, and tumor protein expression changes were measured and correlated with clinical response at 3 months.
A total of 20 patients were enrolled at two institutions. The maximum tolerated dose (MTD) of sorafenib in combination with ILI-M was 400 mg. Four dose-limiting toxicities occurred, including soft tissue ulcerations and compartment syndrome. There were three CRs (15 %) and four partial responses (20 %). Of patients with the Braf mutation, 83 % (n = 6) progressed compared with only 33 % without (n = 12). Short-term sorafenib treatment did alter protein expression as measured with reverse phase protein array (RPPA) analysis, but did not inhibit protein expression in the MAP kinase pathway. Sorafenib did not alter melphalan pharmacokinetics.
This trial defined the MTD of systemically administered sorafenib in combination with ILI-M. Although some responses were seen, the addition of sorafenib to ILI-M did not appear to augment the effects of melphalan but did increase regional toxicity.
PMCID: PMC4402212  PMID: 22549288
2.  Women's preferences for information and complication seriousness ratings related to elective medical procedures 
Journal of Medical Ethics  2006;32(8):435-438.
To study the preferences of patients for information related to elective procedures.
A survey was carried out using a sample of 187 women. The majority of whom were on a low‐income, who obtained obstetric or gynaecological services at St Joseph Regional Medical Center in Milwaukee, Wisconsin, while they were in a waiting room.
Many of the complications, including those that are uncommon and less serious, were considered to be relevant to the medical decisions of most patients. Average seriousness ratings associated with complications of various elective procedures were in the range of moderate to high. A frequency of complications of 1:100 or higher would factor into most women's elective treatment decisions. Women indicated a preference for receiving as much or more information pertaining to complications associated with particular elective obstetric or gynaecological procedures as other elective procedures.
Most women wish to be informed of risks and treatment alternatives, rate many complications as serious, and are likely to use information provided to make elective treatment decisions.
PMCID: PMC2563388  PMID: 16877620
3.  The evolution of the emergency care practitioner role in England: experiences and impact 
Emergency Medicine Journal : EMJ  2006;23(6):435-439.
The emergency care practitioner (ECP) is a generic practitioner who combines extended nursing and paramedic skills. The "new" role emerged out of changing workforce initiatives intended to improve staff career opportunities in the National Health Service and ensure that patients' health needs are assessed appropriately.
To describe the development of ECP Schemes in 17 sites, identify criteria contributing to a successful operational framework, analyse routinely collected data and provide a preliminary estimate of costs.
There were three methods used: (a) a quantitative survey, comprising a questionnaire to project leaders in 17 sites, and analysis of data collected routinely; (b) qualitative interpretation based on telephone interviews in six sites; and (c) an economic costing study.
Of 17 sites, 14 (82.5%) responded to the questionnaire. Most ECPs (77.4%) had trained as paramedics. Skills and competencies have been extended through educational programmes, training, and assessment. Routine data indicate that 54% of patient contacts with the ECP service did not require a referral to another health professional or use of emergency transport. In a subset of six sites, factors contributing to a successful operational framework were strategic visions crossing traditional organisational boundaries and appropriately skilled workforce integrating flexibly with existing services. Issues across all schemes were patient safety, appropriate clinical governance, and supervision and workforce issues. On the data available, the mean cost per ECP patient contact is £24.00, which is less than an ED contact of £55.00.
Indications are that the ECP schemes are moving forward in line with original objectives and could be having a significant impact on the emergency services workload.
PMCID: PMC2564336  PMID: 16714501
emergency care practitioner; intermediate care; extended skills; avoided admission
4.  Influence of evidence-based guidance on health policy and clinical practice in England 
Quality in Health Care : QHC  2001;10(4):229-237.
Objectives—To examine the influence of evidence-based guidance on health care decisions, a study of the use of seven different sources and types of evidence-based guidance was carried out in senior health professionals in England with responsibilities either for directing and purchasing health care based in the health authorities, or providing clinical care to patients in trust hospitals or in primary care.
Design—Postal survey.
Setting—Three health settings: 46 health authorities, 162 acute and/or community trust hospitals, and 96 primary care groups in England.
Sample—566 subjects (46 directors of public health, 49 directors of purchasing, 375 clinical directors/consultants in hospitals, and 96 lead general practitioners).
Main outcome measures—Knowledge of selected evidence-based guidance, previous use ever, beliefs in quality, usefulness, and perceived influence on practice.
Results—A usable response rate of 73% (407/560) was achieved; 82% (334/407) of respondents had consulted at least one source of evidence-based guidance ever in the past. Professionals in the health authorities were much more likely to be aware of the evidence-based guidance and had consulted more sources (mean number of different guidelines consulted 4.3) than either the hospital consultants (mean 1.9) or GPs in primary care (mean 1.8). There was little variation in the belief that the evidence-based guidance was of "good quality", but respondents from the health authorities (87%) were significantly more likely than either hospital consultants (52%) or GPs (57%) to perceive that any of the specified evidence-based guidance had influenced a change of practice. Across all settings, the least used route to accessing evidence-based guidance was the Internet. For several sources an effect was observed between use ever, the health region where the health professional worked, and the region where the guidance was produced or published. This was evident for some national sources as well as in those initiatives produced locally with predominantly local distribution networks.
Conclusions—The evidence-based guidance specified was significantly more likely to be seen to have contributed to the decisions of public health specialists and commissioners than those of consultants in hospitals or of GPs in a primary care setting. Appropriate information support and dissemination systems that increase awareness, access, and use of evidence-based guidance at the clinical interface should be developed.
Key Words: evidence-based guidance; guidelines; evidence-based medicine
PMCID: PMC1743459  PMID: 11743152
5.  Will alternative immediate care services reduce demands for non-urgent treatment at accident and emergency? 
Emergency Medicine Journal : EMJ  2001;18(6):482-487.
Methods—A questionnaire survey and notes review of 267 adults presenting to the A&E department of a large teaching hospital in Sheffield, England, triaged to the two lowest priority treatment streams, was conducted over seven weeks. Using defined criteria, patients were classified by the suitability of the presenting health problem to be managed by alternative immediate care services or only by A&E, and also by the likelihood, in similar circumstances, of patients presenting to other services given their reasons for seeking A&E care.
Results—Full data were obtained for 96% of participants (255 of 267). Using objective criteria, it is estimated that 55% (95% CI 50%, 62%) of the health problems presented by a non-urgent population attending A&E are suitable for treatment in either general practice, or a minor injury unit, or a walk in centre or by self care after advice from NHS Direct. However, in almost one quarter (24%) of low priority patients who self referred, A&E was not the first contact with the health services for the presenting health problem. The reason for attending A&E cited most frequently by the patients was a belief that radiography was necessary. The reason given least often was seeking advice from a nurse practitioner. Taking into account the objective suitability of the health problem to be treated elsewhere, and the reasons for attending A&E given by the patients, it is estimated that, with similar health problems, as few as 7% (95% CI 3%, 10%) of the non-urgent A&E population may be expected to present to providers other than A&E in the future.
Conclusions—The increasing availability of alternative services offering first contact care for non-urgent health problems, is likely to have little impact on the demand for A&E services.
PMCID: PMC1725697  PMID: 11696509
6.  Can we prevent accidental injury to adolescents? A systematic review of the evidence. 
Injury Prevention  1995;1(4):249-255.
OBJECTIVES: As part of the Department of Health strategy The Health of the Nation, a systematic review of published and unpublished literature relating to the effectiveness of interventions in reducing accidental injury in the population aged 15-24 years was carried out. METHODS: The literature was reviewed under the standard setting headings of road, work, home, and sports and leisure, and graded for quality of evidence and strength of recommendation using a scale published in the UK national epidemiologically based needs assessment programme. RESULTS: The most effective measures appear to be legislative and regulatory controls in road, sport, and workplace settings. Environmental engineering measures on the road and in sports have relatively low implementation costs and result in fewer injuries at all ages. There is little evidence that purely educational measures reduced injuries in the short term. Community based approaches may be effective in all age groups, and incentives to encourage safer behaviour hold promise but require further evaluation. The potential of multifactorial approaches seems greater than narrowly based linear approaches. CONCLUSIONS: Few interventions to reduce injury in adolescents have been rigorously evaluated using good quality randomised controlled trials, and where such evidence is available, fewer have been shown to be definitely worthwhile. Many studies relied on surrogate measures rather than actual injury rates, and substantial issues relating to the efficacy or implementation of preventive measures in adolescent and young adult populations remain unresolved.
PMCID: PMC1067615  PMID: 9346041
7.  Personality, health and ageing. 
Journal of the Royal Society of Medicine  1997;90(Suppl 32):27-33.
PMCID: PMC1296074  PMID: 9404314
8.  Assessing the outcome of making it easier for patients to change general practitioner: practice characteristics associated with patient movements. 
BACKGROUND. The government white paper, Promoting better health, suggested that primary health care services should be made more responsive to patient needs and that competition, brought about by the freer movement of patients between practices, could act as a mechanism for improving the quality of the services provided. Policy changes reflecting these aims were introduced with the 1990 contract for general practitioners. AIM. A study was carried out to estimate the volume of patient movement between practices not attributable to a patient's change of address or to a major change in the practice they had left, and to investigate which practice characteristics patients moved towards and which they moved away from when changing general practitioner. METHOD. Data on 2617 patient movements during June 1991 were collected from five family health services authorities. These patient movements were analysed in relation to data on practice characteristics obtained from family health services authority records. RESULTS. The estimated volume of movement of patients between practices was small (1.6% of the registered population per year). The majority of movements were between group practices; a quarter of the movements recorded were to single-handed general practitioners. However, the ratio of the number of movements from group practices to single-handed general practitioners compared with those from single-handed general practitioners to group practices was 1.37 (95% confidence interval 1.19 to 1.57). In choosing single-handed general practitioners these patients were willing to forgo access to a woman general practitioner, extended services and greater hours of general practitioner availability. Among the subset of movements between group practices, patients were more likely to gain access to a practice nurse, longer surgery hours and a woman general practitioner as a consequence of their move. CONCLUSION. The scale of patient movement observed did not indicate any substantial mechanism by which the new policy of encouraging consumerist behaviour on the part of primary care users could effect desired changes in primary care practice. Among the patient movements observed, the evidence suggests that when choosing a practice potential patients were not deterred by the fact that a practice was single-handed. The public's perception of the factors contributing to a high quality of service may conflict with the official characterization of good practice and high quality services in primary health care.
PMCID: PMC1239432  PMID: 8554837
10.  The epidemiology of sports and exercise related injury in the United Kingdom. 
A national study of exercise related morbidity (ERM) in England and Wales was carried out using a postal questionnaire sent to 28,857 adults aged 16-45 years. The questionnaire asked about regular participation in sports or other recreational fitness activities involving physical exercise, and for details of any injuries occurring during a 28 d reference period. A return rate of 68% was achieved. Comparisons with other national data sources indicated that the information obtained was reliable. It is estimated that each year there are 29 million incidents resulting in new or recurrent injuries, however minor, of which 9.8 million (95% confidence interval 8.1 to 11.4 million) result in new 'substantive' injuries which are potentially serious, result in treatment, or in participants being unable to take part in their usual activities. Soccer accounted for more than 25% of all ERM, but the risk of a substantive injury in rugby was three times that in soccer. Over one third of ERM occurred in men aged 16-25 years. The most frequently reported injuries were sprains and strains of the lower limbs. Treatment was sought in approximately 25% of ERM incidents and 7% of all new ERM incidents involved attendance at a hospital accident and emergency department. The treatment provider most likely to be consulted was a general practitioner, but physiotherapists and complementary medicine practitioners were also consulted frequently. To maximize the health benefits of exercise, research strategies to reduce the volume and severity of ERM and to identify the most appropriate ways of managing ERM should be set.
PMCID: PMC1332232  PMID: 8808535
11.  Evaluation of enzyme immunoassay (EIA) as a screening method for hepatitis B markers in an open population. 
Epidemiology and Infection  1991;107(3):673-684.
Commercially available kits for detection of hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) by enzyme immunoassay (EIA) were evaluated in American Samoa during a public health programme to eliminate the transmission of hepatitis B. The first 19,184 serum specimens obtained, representing 68% of the total cooperating population, were initially tested for anti-HBs, and those without detectable antibody were tested for HBsAg. All the antigen-positive serum samples, and a selection of the antigen- and antibody-negative specimens were tested by radioimmunoassay (RIA) for detection of both markers. Compared with the standard tests, the EIA kits for anti-HBs and HBsAg performed well; sensitivity and specificity were 90.3 and 96.0%, respectively, for antibody, and 97.8 and 97.9% respectively for antigen. Substantial disagreement between the EIA and RIA tests for HBsAg was found only for specimens considered weakly reactive by EIA. Few differences were found between three EIA method options for follow-up HBsAg testing of weakly reactive serum specimens; each option contributed about equally to improved test specificity for these 'borderline' specimens. Based on their demonstrated equivalence to the standard RIA tests, we conclude that the EIA kits for anti-HBs and HBsAg detection are suitable for use in hepatitis B control programmes in open populations.
PMCID: PMC2272086  PMID: 1752314
12.  Hepatitis B vaccination programs for health care personnel in U.S. hospitals. 
Public Health Reports  1990;105(6):610-616.
A random sample of 232 U.S. hospitals was surveyed. Of those hospitals, 75 percent had hepatitis B vaccination programs. The presence of a program was associated with hospital size (60 percent of those with 100 beds, 75 percent with 100-499 beds, 90 percent with 500 or more beds; P = 0.0013) and hospital location (urban 86 percent; rural 57 percent; P less than 0.001). The frequency of needlestick exposures per month among hospital personnel and hospital location were directly related to and best predicted the existence of hepatitis B vaccination programs. All hospitals with programs offered vaccine to high-risk personnel (as defined by the hospital). Seventy-seven percent of hospitals paid all costs for vaccinating high-risk personnel; 19 percent paid for any employee to be vaccinated regardless of risk status. Forty-six percent of hospitals with programs were estimated to have vaccinated more than 10 percent of all eligible personnel, and 13 percent to have vaccinated more than 25 percent of eligible personnel. The highest compliance rates were associated with hospitals paying for the vaccine and requiring vaccination of high-risk personnel. Fifty-four percent of hospitals attributed noncompliance to concern regarding vaccine safety and effectiveness. The reasons why there was no vaccination program in 58 hospitals were (a) low incidence of hepatitis B virus infections among personnel, (b) cost of vaccine, and (c) vaccination being offered as part of a needlestick protocol. Full utilization of hepatitis B vaccine could eliminate the occupational hazard that hepatitis B virus presents to health care personnel.
PMCID: PMC1580184  PMID: 2148012
13.  Pilot study of the epidemiology of sports injuries and exercise-related morbidity. 
In the pilot phase of a national study of the incidence of exercise-related morbidity (ERM), funded by the Sports Council, a questionnaire about recent participation in 'active sports and other recreational activities involving vigorous physical exercise' and associated injuries or illnesses was sent to a sample of 6744 people aged 16 to 65 years in two areas. Interviews with 101 respondents were held to validate the questions. Return rates of 73 and 81% from the two areas were achieved and results from the interviews indicated that sports and injuries were being reported sufficiently accurately on the postal questionnaires to yield reliable information. Of the 4961 usable returns, a total of 1249 respondents (25%) reported taking part in some activity in the 4 weeks before completing the questionnaire, and 137 (3%) reported 158 injury incidents. Nearly half (76, 48%) of these incidents resulted in some restriction in activity, and 21 resulted in some restriction in activity, and 21 resulted in a visit to a hospital casualty department. It is estimated that nationally 1-1.5 million episodes of ERM result annually in attendance at a hospital casualty department, and 4-5 million episodes of ERM result in some, usually temporary, incapacity.
PMCID: PMC1478793  PMID: 1913036
14.  TestPack Chlamydia, a new rapid assay for the direct detection of Chlamydia trachomatis. 
Journal of Clinical Microbiology  1989;27(12):2811-2814.
TestPack Chlamydia (Abbott Laboratories) is a rapid enzyme immunoassay for the direct antigen detection of Chlamydia trachomatis in endocervical specimens. The assay is self-contained, requires no specialized equipment, and yields results in less than 30 min. The clinical performance of TestPack Chlamydia versus chlamydial cell culture was evaluated with a total of 1,694 paired endocervical specimens. Discordant samples were further investigated by immunofluorescent staining and by Chlamydiazyme immunoassay, with confirmatory procedures. The sensitivity of TestPack Chlamydia with less-than-48-h-old specimens was 76.5%, while culture sensitivity was 86.7%. TestPack Chlamydia specificity was determined to be 99.5%. These results indicate that TestPack Chlamydia is an accurate test for chlamydial infection, with a positive predictive value of 96.2%. This assay is suitable for low-volume chlamydial testing in physician offices, clinics, and smaller laboratories.
PMCID: PMC267131  PMID: 2592542
16.  Drs Hunt & Coleman reply 
British Journal of Cancer  1988;57(2):236-237.
PMCID: PMC2246443
17.  Evaluation of chlamydiazyme for the detection of genital infections caused by Chlamydia trachomatis. 
Journal of Clinical Microbiology  1986;23(2):329-332.
Chlamydiazyme is a 4-h enzyme-linked immunoassay that detects an antigen of Chlamydia trachomatis directly in clinical specimens. This immunoassay was compared with cell culture for the diagnosis of chlamydial infections of the genital tract. The assay was evaluated at five clinics with a total of 1,277 cervical specimens of which 239 were culture positive. At three of these clinics where urethral samples were taken from males, 99 of 363 samples were culture positive. The sensitivity of the assay averaged 89.5% for detecting cervical infections and 78.8% for detecting male urethral infections. Specificity was 97.0% when samples from either males or females were tested. Some patients who were culture negative were infected with chlamydiae according to both Chlamydiazyme and a monoclonal antibody test that detected a chlamydial antigen distinct from the antigen detected by Chlamydiazyme. If the 15 females and 2 males who were positive by both immunoassays but culture negative were considered positive for chlamydial infection, the specificity of the assay was 98.4% in females and 97.7% in males. Chlamydiazyme is a simple and relatively rapid immunoassay that has sufficient sensitivity and specificity to supplant culture in the detection of genital chlamydial infections.
PMCID: PMC268636  PMID: 3517052
18.  Resistance to infections in mice with defects in the activities of mononuclear phagocytes and natural killer cells: effects of immunomodulators in beige mice and 89Sr-treated mice. 
Infection and Immunity  1982;37(3):1079-1085.
Beige mice, which are a homolog of the Chediak-Higashi syndrome, and mice treated with 89Sr to destroy the bone marrow provide animal models of defects in mononuclear phagocyte and natural killer cell functions. The innate resistance of these mice to viruses such as herpes simplex and encephalomyocarditis viruses, however, is normal. Moreover, treatment of the mice with immunomodulators such as Propionibacterium acnes (formerly designated Corynebacterium parvum) and pyran produced a significant increase in resistance to encephalomyocarditis virus. The antiviral effect of P. acnes in 89Sr-treated mice was exhibited during marked monocytopenia and without evidence for an inflammatory influx of macrophages into the peritoneal cavity. Treatment with P. acnes was also effective in increasing the resistance of beige mice to infection with Listeria monocytogenes. Thus, immunomodulators can be effective in mice that exhibit impaired macrophage and natural killer cell functions.
PMCID: PMC347651  PMID: 6290389
19.  General Medical Council 
British Medical Journal  1972;4(5839):548.
PMCID: PMC1788707
20.  New Consultant Contract 
British Medical Journal  1972;3(5825):532.
PMCID: PMC1785764
21.  New Consultant Contract 
British Medical Journal  1972;2(5812):532-533.
PMCID: PMC1788329
22.  Chronic Infection of the Rabbit Central Nervous System by a Slowly Growing Equine Herpesvirus 
Infection and Immunity  1972;5(2):172-175.
The spinal cords of rabbits were chronically infected by a slowly growing horse herpesvirus (a “cytomegalovirus”) inoculated directly therein. Virus was recovered from the central nervous systems of some of such animals after more than 1 year. The virus could be reisolated from all the animals killed during the first few weeks after its injection; acute focal meningomyelitis was present with involvement of gray and white matter of the cervical, thoracic, and lumbar levels of the spinal cords of these rabbits, though the nerve cells themselves remained undamaged. Thereafter, reisolation of the virus became sporadic, and no damage to the spinal cord could be histologically discerned even in animals from which the virus was recovered. No paralytic or other clinical effects could be attributed to the infection.
PMCID: PMC422343  PMID: 4344089
23.  Measurement of red cell diameter by image shearing. 
Journal of Clinical Pathology  1967;20(6):915-917.
PMCID: PMC473641  PMID: 5614079
24.  Vaginal Cytology Service 
British Medical Journal  1966;1(5503):1600.
PMCID: PMC1844792

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