The United Kingdom Infantile Spasms Study (UKISS) comparing hormone treatment with vigabatrin on developmental and epilepsy outcomes to age 14 months: a multicentre randomised trial

In 1969 universal clinical screening for neonatal hip instability was formally adopted in the United Kingdom with the aim of detecting and treating children considered to be at high risk of congenital dislocation of the hip (CDH). However, clinical screening is associated with both false positive and false negative diagnoses and has never been evaluated in a randomised trial. The emergence of hip ultrasound provides renewed impetus to reconsider and formally evaluate screening for CDH. Ultrasound imaging of the newborn hip may be used as a screening test and to assess and manage infants with clinically detected hip instability. Universal primary ultrasound screening has been adopted in some European countries, but enthusiasm for this new technology has been tempered by the subsequent large' increases in treatment and follow up. This paper reviews the existing evidence to support the different approaches to screening and describes the research agenda of the MRC working party on congenital dislocation of the hip. A randomised trial of screening is required to evaluate the policy options before ultrasound screening becomes widely adopted within the United Kingdom. The feasibility and acceptability of a trial need to be explored and key issues relating to trial design addressed.

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Survival of Patients with Breast Cancer Diagnosed in the United Kingdom Trial of Early Detection of Breast Cancer

Journal of Medical Screening ◽

10.1177/096914139400100312 ◽

1994 ◽

Vol 1 (3) ◽

pp. 193-198 ◽

Cited By ~ 16

Author(s):

S M Moss ◽

R Ellman ◽

D Coleman ◽

J Chamberlain ◽

Keyword(s):

Breast Cancer ◽

United Kingdom ◽

Early Detection ◽

Cancer Mortality ◽

Tumour Size ◽

Univariate Analysis ◽

Breast Cancer Mortality ◽

Randomised Trial ◽

The United Kingdom ◽

Significant Difference

To examine the survival of patients with breast cancer diagnosed in different centres and by different methods in the United Kingdom trial of early detection of breast cancer, in order to investigate the contribution of different factors to the previously observed reductions in breast cancer mortality. A non-randomised trial of the early detection of breast cancer, in which women aged 45–64 in two districts were offered annual screening for seven years, women in a further two districts were offered education about breast self examination (BSE), and those in four districts formed a comparison group. Patients with breast cancer are classified according to the type of centre, method of detection, and attendance for BSE education. Univariate and multivariate survival analyses are carried out, including tumour size, dissemination status, and use of adjuvant treatment as additional variables. In the univariate analysis, patients with breast cancer who are nonattenders for screening have a significantly worse prognosis than those in the comparison centres. Patients whose cancer is detected by mammography have the best survival rate. The inclusion of size and dissemination status in the multivariate analysis explains only about one third of the improved prognosis in these cases. There is a significant difference between prognosis in the two BSE centres. The use of prognostic factors as recorded in this trial to predict breast cancer mortality may be inadequate.

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P201 The aetiology of infantile spasms: information from the United Kingdom Infantile Spasms Study (UKISS) using an adaptation of the paediatric classification from ICD 10

European Journal of Paediatric Neurology ◽

10.1016/s1090-3798(09)70259-4 ◽

2009 ◽

Vol 13 ◽

pp. S82

Author(s):

E. Hancock ◽

R.W. Newton ◽

A.L. Lux ◽

J.P. Osborne ◽

S.W. Edwards ◽

...

Keyword(s):

United Kingdom ◽

Infantile Spasms ◽

The United Kingdom ◽

Icd 10

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The underlying etiology of infantile spasms (West syndrome): Information from the United Kingdom Infantile Spasms Study (UKISS) on contemporary causes and their classification2

Epilepsia ◽

10.1111/j.1528-1167.2010.02695.x ◽

2010 ◽

Vol 51 (10) ◽

pp. 2168-2174 ◽

Cited By ~ 132

Author(s):

John P. Osborne ◽

Andrew L. Lux ◽

Stuart W. Edwards ◽

Eleanor Hancock ◽

Anthony L. Johnson ◽

...

Keyword(s):

United Kingdom ◽

Infantile Spasms ◽

West Syndrome ◽

The United Kingdom

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Infantile Spasms and Epilepsy Currents

Epilepsy Currents ◽

10.1111/j.1535-7511.2005.00047.x ◽

2005 ◽

Vol 5 (4) ◽

pp. 157-158 ◽

Cited By ~ 2

Author(s):

Elinor Ben-Menachem

Keyword(s):

United Kingdom ◽

Adverse Events ◽

Controlled Trial ◽

Oral Prednisolone ◽

Infantile Spasms ◽

High Morbidity ◽

Intention To Treat ◽

The United Kingdom ◽

Multicenter Randomized Controlled Trial ◽

Hormonal Treatments

The United Kingdom Infantile Spasms Study Comparing Vigabatrin with Prednisolone or Tetracosactide at 14 Days: A Multicentre, Randomised Controlled Trial Lux AL, Edwards SW, Hancock E, Johnson AL, Kennedy CR, Newton RW, O'Callaghan FJ, Verity CM, Osborne JP Lancet 2004;364:1773–1778 Purpose Infantile spasms, a severe infantile seizure disorder, have a high morbidity and are difficult to treat. Hormonal treatments (adrenocorticotropic hormone and prednisolone) have been the main therapy for decades, although little evidence supports their use. Vigabatrin has been recorded to have a beneficial effect in this disorder. We aimed to compare the effects of vigabatrin with those of prednisolone and tetracosactide in the treatment of infantile spasms. Methods The United Kingdom Infantile Spasms Study assessed these treatments in a multicenter, randomized controlled trial in 150 hospitals in the United Kingdom. The primary outcome was cessation of spasms on days 13 and 14. Minimum doses were vigabatrin, 100 mg/kg/day; oral prednisolone, 40 mg/day; or intramuscular tetracosactide depot, 0.5 mg (40 IU) on alternate days. Analysis was by intention to treat. Results Of 208 infants screened and assessed, 107 were randomly assigned to vigabatrin ( n = 52) or hormonal treatments (prednisolone, n = 30; tetracosactide, n = 25). None was lost to follow-up. Proportions with no spasms on days 13 and 14 were 40 (73%) of 55 infants assigned hormonal treatments (prednisolone, 21 of 30 [70%]; tetracosactide, 19 of 25 [76%]) and 28 (54%) of 52 infants assigned vigabatrin (difference, 19%; 95% CI, 1%–36%, p = 0.043). Two infants allocated tetracosactide and one allocated vigabatrin received prednisolone. Adverse events were reported in 30 (55%) of 55 infants receiving hormonal treatments and 28 (54%) of 52 infants receiving vigabatrin. No deaths were recorded. Conclusions Cessation of spasms was more likely in infants given hormonal treatments than in those given vigabatrin. Adverse events were common with both treatments.

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The United Kingdom Infantile Spasms Study comparing vigabatrin with prednisolone or tetracosactide at 14 days: a multicentre, randomised controlled trial

The Lancet ◽

10.1016/s0140-6736(04)17400-x ◽

2004 ◽

Vol 364 (9447) ◽

pp. 1773-1778 ◽

Cited By ~ 200

Author(s):

Andrew L Lux ◽

Stuart W Edwards ◽

Eleanor Hancock ◽

Anthony L Johnson ◽

Colin R Kennedy ◽

...

Keyword(s):

United Kingdom ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Infantile Spasms ◽

The United Kingdom ◽

Randomised Controlled

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The effect of lead time to treatment and of age of onset on developmental outcome at 4 years in infantile spasms: Evidence from the United Kingdom Infantile Spasms Study

Epilepsia ◽

10.1111/j.1528-1167.2011.03127.x ◽

2011 ◽

Vol 52 (7) ◽

pp. 1359-1364 ◽

Cited By ~ 123

Author(s):

Finbar J. K. O’Callaghan ◽

Andrew L. Lux ◽

Katrina Darke ◽

Stuart W. Edwards ◽

Eleanor Hancock ◽

...

Keyword(s):

United Kingdom ◽

Lead Time ◽

Age Of Onset ◽

Infantile Spasms ◽

Developmental Outcome ◽

Time To Treatment ◽

The United Kingdom

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The Violence of Postmodern "Gender Identity" Medicine

Dignity A Journal on Sexual Exploitation and Violence ◽

10.23860/dignity.2021.06.03.08 ◽

2021 ◽

Vol 6 (3) ◽

Author(s):

Heather Brunskell-Evans ◽

Keyword(s):

United Kingdom ◽

Identity Development ◽

Gender Identity ◽

Mental Health Professionals ◽

Gender Dysphoria ◽

Western Europe ◽

Children's Rights ◽

Hormone Treatment ◽

Children’S Rights ◽

The United Kingdom

The medical “transition” of children with “gender dysphoria” is increasingly normalized in North America, Western Europe, Australia, New Zealand, and the United Kingdom. Although each country has specific national gender identity development services, the rationale for prescribing hormone treatment is broadly similar. A minority rights paradigm underpinned by postmodern theory has gained traction in the past 10 years and has been successful in influencing public policy, the education of pediatricians, endocrinologists, and mental health professionals. In this view, any response other than an affirmation of the child’s claim to be the opposite sex or “born in the wrong body” is understood as a denial of their human rights to have their “outer” body match their authentic “inner” self. The postmodern paradigm has brought about a concomitant shift in the classification of the patient from a child who suffers “gender dysphoria” to a child who is “transgender”. Yet the practice of putting children on a medical pathway brings severe, life-long consequences including bone/skeletal impairment, cardiovascular and surgical complications, reduced sexual functioning, and infertility. Examination of postmodern “transgender” health care reveals it is rarely expert, evidenced-based or objective but on the contrary, is highly politicized and controversial. Although the High Court in the United Kingdom has ruled those children 16 years and under cannot consent to hormone treatment, several lobby groups, as well as the NHS Tavistock and Portman Hospital Trust Gender Identity Development Service (GIDS), have been granted legal permission to challenge the ruling. With the example of the United Kingdom, I demonstrate that if the appeal is successful, children’s rights to protection from bodily and psychological harm will continue to be abused by the postmodern social justice paradigm which, in the very name of upholding children’s rights, violates them.

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Control of Hormone Treatment in Animals and Residues in Meat—Regulatory Aspects and Approaches in Methodology

Journal of AOAC INTERNATIONAL ◽

10.1093/jaoac/61.5.1201 ◽

1978 ◽

Vol 61 (5) ◽

pp. 1201-1208

Author(s):

Heinrich Karg ◽

Karl Vogt

Keyword(s):

United Kingdom ◽

Animal Husbandry ◽

Hormone Treatment ◽

The United States ◽

Anabolic Agents ◽

The United Kingdom ◽

Illegal Treatments ◽

Oral Activity ◽

Methodological Approaches ◽

Layer Chromatography

Abstract Although the benefit of using anabolic hormones for fattening purposes under specific situations in animal husbandry (for instance, veal production) has been acknowledged in European countries, the regulatory consequences were quite different from those in the United States. With the exception of the United Kingdom, there were no approvals to use estrogens for other than distinct veterinary purposes. Hence the methodological approaches were rather to control the illegal treatments and imports. One measure is the uterus weight bioassay. Furthermore morphological parameters (prostate test) and estrogen determinations by thin layer chromatography in urine (also from the bladder) were proposed for detection of treated animals. Radioimmunoassays are in development and considered sensitive enough for residue studies in carcasses, perhaps applicable in combination with high pressure liquid chromatography. The re-evaluation of the regulatory situation is in progress in France and Germany and under consideration in the United Kingdom. Guidelines may be the recommendations of the FAO/WHO Symposium 1975 in Rome on anabolic agents in animal production indicating the variety of risks due to different compounds in question and preference to those with low oral activity and defined bio-degradation.

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