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1.  Instability of Misoprostol Tablets Stored Outside the Blister: A Potential Serious Concern for Clinical Outcome in Medical Abortion 
PLoS ONE  2014;9(12):e112401.
Introduction
Misoprostol (Cytotec) is recognised to be effective for many gynaecological indications including termination of pregnancy, management of miscarriage and postpartum haemorrhage. Although not licensed for such indications, it has been used for these purposes by millions of women throughout the world. Misoprostol tablets are most often packaged as multiple tablets within an aluminium strip, each within an individual alveolus. When an alveolus is opened, tablets will be exposed to atmospheric conditions.
Objective
To compare the pharmaco technical characteristics (weight, friability), water content, misoprostol content and decomposition product content (type A misoprostol, type B misoprostol and 8-epi misoprostol) of misoprostol tablets Cytotec (Pfizer) exposed to air for periods of 1 hour to 720 hours (30 days), to those of identical non exposed tablets.
Methods
Four hundred and twenty (420) tablets of Cytotec (Pfizer) were removed from their alveoli blister and stored at 25°C/60% relative humidity. Water content, and misoprostol degradation products were assayed in tablets exposed from 1 to 720 hours (30 days). Comparison was made with control tablets (N = 60) from the same batch stored in non-damaged blisters. Statistical analyses were carried out using Fisher’s exact test for small sample sizes.
Results
By 48 hours, exposed tablets demonstrated increased weight (+4.5%), friability (+1 300%), and water content (+80%) compared to controls. Exposed tablets also exhibited a decrease in Cytotec active ingredient dosage (−5.1% after 48 hours) and an increase in the inactive degradation products (+25% for type B, +50% for type A and +11% for 8-epi misoprostol after 48 hours) compared to controls.
Conclusion
Exposure of Cytotec tablets to ‘typical’ European levels of air and humidity results in significant time-dependent changes in physical and biological composition that could impact adversely upon clinical efficacy. Health professionals should be made aware of the degradation of misoprostol with inappropriate storage of misoprostol tablets.
doi:10.1371/journal.pone.0112401
PMCID: PMC4266501  PMID: 25502819
2.  Can we reduce costs and prevent more unintended pregnancies? A cost of illness and cost-effectiveness study comparing two methods of EHC 
BMJ Open  2013;3(12):e003815.
Objectives
To calculate the cost of an unintended pregnancy in 2011 and use this cost in a cost-effectiveness model comparing ulipristal acetate (UPA) with levonorgestrel (LNG) for emergency hormonal contraception (EHC).
Design
Retrospective analysis of published data sources and published cost-effectiveness model.
Setting
Women presenting in primary care in England for EHC within 24 or 72 h of unprotected sexual intercourse (UPSI).
Interventions
EHC of either LNG (1.5 mg) or UPA (30 mg).
Primary and secondary outcome measures
The primary outcome measure is the number and direct and indirect costs of an unintended pregnancy. The secondary outcome measure is the consequence of unintended pregnancy: miscarriage, abortion, ectopic pregnancy, stillbirth or live birth.
Results
From the comparative clinical studies of EHC we observe that if 125 women receive either LNG or UPA within 72 h of UPSI, there will be one less pregnancy due to method failure in the UPA group than in the LNG group. We calculate the cost of an unintended pregnancy to be £1663 in direct healthcare costs rising to £2922 with the inclusion of social costs. Using these costs in the comparative cost-effectiveness model shows that it costs £194 less in direct health costs alone to prevent one more pregnancy with UPA than with LNG. The inclusion of social costs of pregnancy increases this cost-saving potential to £1453 for each extra pregnancy avoided with UPA compared with LNG.
Conclusions
Clinical trials have demonstrated the superior efficacy of UPA compared with LNG as a method of EHC. Given that it costs less overall in health and social costs of pregnancy while preventing more pregnancies, UPA is said to be the dominant treatment, and primary care services should shift to offering UPA as the preferred oral option to women presenting within 24 and 72 h of UPSI.
doi:10.1136/bmjopen-2013-003815
PMCID: PMC3884700  PMID: 24353255
Health Economics; Public Health; Sexual Medicine
3.  Mechanisms for an effect of acetylcysteine on renal function after exposure to radio-graphic contrast material: study protocol 
Background
Contrast-induced nephropathy is a common complication of contrast administration in patients with chronic kidney disease and diabetes. Its pathophysiology is not well understood; similarly the role of intravenous or oral acetylcysteine is unclear. Randomized controlled trials to date have been conducted without detailed knowledge of the effect of acetylcysteine on renal function. We are conducting a detailed mechanistic study of acetylcysteine on normal and impaired kidneys, both with and without contrast. This information would guide the choice of dose, route, and appropriate outcome measure for future clinical trials in patients with chronic kidney disease.
Methods/Design
We designed a 4-part study. We have set up randomised controlled cross-over studies to assess the effect of intravenous (50 mg/kg/hr for 2 hrs before contrast exposure, then 20 mg/kg/hr for 5 hrs) or oral acetylcysteine (1200 mg twice daily for 2 days, starting the day before contrast exposure) on renal function in normal and diseased kidneys, and normal kidneys exposed to contrast. We have also set up a parallel-group randomized controlled trial to assess the effect of intravenous or oral acetylcysteine on patients with chronic kidney disease stage III undergoing elective coronary angiography. The primary outcome is change in renal blood flow; secondary outcomes include change in glomerular filtration rate, tubular function, urinary proteins, and oxidative balance.
Discussion
Contrast-induced nephropathy represents a significant source of hospital morbidity and mortality. Over the last ten years, acetylcysteine has been administered prior to contrast to reduce the risk of contrast-induced nephropathy. Randomized controlled trials, however, have not reliably demonstrated renoprotection; a recent large randomized controlled trial assessing a dose of oral acetylcysteine selected without mechanistic insight did not reduce the incidence of contrast-induced nephropathy. Our study should reveal the mechanism of effect of acetylcysteine on renal function and identify an appropriate route for future dose response studies and in time randomized controlled trials.
Trial registration
Clinical Trials.gov: NCT00558142; EudraCT: 2006-003509-18.
doi:10.1186/1472-6904-12-3
PMCID: PMC3293780  PMID: 22305183
Contrast-induced nephropathy; acetylcysteine; prevention; kidney; contrast media
4.  Problems Hearing in Noise in Older Adults 
Trends in Amplification  2011;15(3):116-126.
Difficulty understanding speech in background noise, even with amplification to restore audibility, is a common problem for hearing-impaired individuals and is especially frequent in older adults. Despite the debilitating nature of the problem the cause is not yet completely clear. This review considers the role of spatial processing ability in understanding speech in noise, highlights the potential impact of disordered spatial processing, and attempts to establish if aging leads to reduced spatial processing ability. Evidence supporting and opposing the hypothesis that spatial processing is disordered among the aging population is presented. With a few notable exceptions, spatial processing ability was shown to be reduced in an older population in comparison to young adults, leading to poorer speech understanding in noise. However, it is argued that to conclude aging negatively effects spatial processing ability may be oversimplified or even premature given potentially confounding factors such as cognitive ability and hearing impairment. Further research is required to determine the effect of aging and hearing impairment on spatial processing and to investigate possible remediation options for spatial processing disorder.
doi:10.1177/1084713811424885
PMCID: PMC4040826  PMID: 22072599
spatial processing; aging; simultaneous stream segregation; speech understanding in noise

Results 1-4 (4)