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Biomedical subjects

Jim Thornton

Publications and source records attributed to Jim Thornton.

12 recordsLinked to original sources

Protocol for the smoking, nicotine and pregnancy (SNAP) trial: double-blind, placebo-randomised, controlled trial of nicotine replacement therapy in pregnancy.

BACKGROUND: Smoking in pregnancy remains a public health challenge. Nicotine replacement therapy (NRT) is effective for smoking cessation in non-pregnant people, but because women metabolise nicotine and cotinine much faster in pregnancy, it is unclear whether this will be effective for smoking cessation in pregnancy. The NHS Health Technology Assessment Programme (HTA)-funded smoking, nicotine and pregnancy (SNAP) trial will investigate whether or not nicotine replacement therapy (NRT) is effective, cost-effective and safe when used for smoking cessation by pregnant women. METHODS/DESIGN: Over two years, in 5 trial centres, 1050 pregnant women who are between 12 and 24 weeks pregnant will be randomised as they attend hospital for ante-natal ultrasound scans. Women will receive either nicotine or placebo transdermal patches with behavioural support. The primary outcome measure is biochemically-validated, self-reported, prolonged and total abstinence from smoking between a quit date (defined before randomisation and set within two weeks of this) and delivery. At six months after childbirth self-reported maternal smoking status will be ascertained and two years after childbirth, self-reported maternal smoking status and the behaviour, cognitive development and respiratory symptoms of children born in the trial will be compared in both groups. DISCUSSION: This trial is designed to ascertain whether or not standard doses of NRT (as transdermal patches) are effective and safe when used for smoking cessation during pregnancy.

Adolescent↗

Accuracy of ultrasound biometry in the prediction of macrosomia: a systematic quantitative review.

OBJECTIVE: To determine the accuracy of ultrasonographically estimated fetal weight (EFW) and abdominal circumference (AC) in the prediction of macrosomia. DESIGN: Systematic quantitative review. METHODS: Studies were identified without language restrictions from MEDLINE (1966-2003), EMBASE (1980-2003), Cochrane Library (2003:4), SCISEARCH (1974-2003) and manual searching of bibliographies of known primary and review articles. Studies were selected if accuracy of ultrasonographically EFW or AC was evaluated for predicting macrosomia using birthweight as the reference standard. Data were extracted on study characteristics, quality and accuracy. Data were pooled to produce summary receiver operating characteristic curves (sROC) for studies with various test thresholds. Summary likelihood ratios for positive (LR+) and negative (LR-) test results were generated for an EFW of 4000 g and an AC of 36 cm for predicting birthweight of over 4000 g. MAIN OUTCOME MEASURES: Birthweight over various thresholds. RESULTS: There were 36 primary articles consisting of 63 accuracy studies (51 evaluating the accuracy of EFW, and 12 accuracy of fetal AC), including a total of 19,117 women. The sROC area for EFW was not different from the area for fetal AC (0.87 vs 0.85, P= 0.91). For predicting a birthweight of over 4000 g, the summary LRs were 5.7 (95% CI: 4.3 to 7.6) for a positive test and 0.48 (95% CI: 0.38 to 0.60) for a negative test, using Hadlock's method of ultrasonographically estimating fetal weight. For ultrasound fetal AC of 36 cm, the respective LRs for predicting a birthweight over 4000 g were 6.9 (95% CI: 5.2 to 9.0) and 0.37 (0.30-0.45). CONCLUSION: There is no difference in accuracy between ultrasonographically EFW and AC in the prediction of a macrosomic baby at birth. A positive test result is more accurate for ruling in macrosomia than a negative test result for ruling it out.

Abdomen↗

Recruiting pregnant smokers for a placebo-randomised controlled trial of nicotine replacement therapy.

BACKGROUND: Smoking in pregnancy is a public health problem and effective methods for reducing this are required. Although nicotine replacement therapy (NRT) is effective for smoking cessation in non-pregnant people, there is no direct evidence concerning its effectiveness in pregnancy. Despite this, clinical guidelines recommend the cautious use of NRT during pregnancy. Randomised controlled trials are needed to determine the safety and efficacy of NRT when used by pregnant women for smoking cessation, but the feasibility of recruiting women to such trials is unknown. Consequently, in this study we aimed to determine i) the feasibility of recruiting women to a RCT of NRT in pregnancy as they attend hospital antenatal ultrasound examinations, ii) the proportion of such women who are eligible for and interested in trial enrollment and iii) research staff perceptions of how one method of trial recruitment could be improved. METHODS: During a one month period, all women attending for antenatal ultrasound examination in an English teaching hospital were asked to complete a questionnaire which determined their eligibility to enroll in a proposed placebo controlled randomised trial investigating the effectiveness of NRT in pregnancy. Women who were eligible to participate were asked whether they would do so and those who accepted enrollment were offered an appointment with a smoking cessation advisor. RESULTS: Over 99% (851/858) of women agreed to complete a questionnaire about smoking habits whilst waiting for ultrasound examinations. 10.3% (88/851) of women attending for antenatal ultrasound fitted eligibility criteria for a proposed RCT of NRT in pregnancy, but only 3.6% [(31/851), 95% CI, 2.4 to 4.9%] indicated on the questionnaire that they would like to take part in a study involving randomisation to placebo or active patches. Researchers offered trial enrollment to 26 of these 31 women and 96% (25) accepted. Staff recruiting women believed that trial recruitment would be maximised if women attending the ultrasound department knew about trial recruitment before attending and greater staff resources were made available for this. It was also perceived that women generally under-reported the amount they smoked on questionnaires completed whilst waiting in ultrasound department areas. CONCLUSIONS: It is feasible to recruit women for a trial of NRT in pregnancy as they wait for antenatal ultrasound examinations. Using similar recruitment methods, researchers can expect to recruit between 24 and 49 women per 1000 approached.

Eligibility Determination↗

The drugs we deserve.

Explore the source record for details and available documents.

Clinical Trials as Topic↗

Killing, letting die and moral perception: a reply to Grant Gillett.

A number of philosophers in recent times have employed arguments to show that there is no morally relevant difference between killing a patient and allowing that patient to die in those circumstances where the outcome is virtually identical and where death is preventable, at least for a significant time. From his perspective as both a philosopher and a clinician, Grant Gillett has rejected such general and abstract arguments in the light of the intuitions and moral perceptions available to clinicians and those who care for the terminally ill. I argue that his strategy fails, is massively question-begging, and that his appeal to the notion of 'moral particularism', far from being an alternative to cogent philosophical argument, actually supports the very position he has attempted to discredit.

Decision Making↗