Cost-Effectiveness of Nicotine Patches for Smoking Cessation in Pregnancy: A Placebo Randomized Controlled Trial (SNAP).

INTRODUCTION: Smoking during pregnancy is the most important, preventable cause of adverse pregnancy outcomes including miscarriage, premature birth, and low birth weight with huge financial costs to the National Health Service. However, there are very few published economic evaluations of smoking cessation interventions in pregnancy and previous studies are predominantly U.S.-based and do not present incremental cost-effectiveness ratios (ICER). A number of studies have demonstrated cost-effectiveness of nicotine replacement therapy (NRT) in the general population, but this has yet to be tested among pregnant smokers. METHODS: A cost-effectiveness analysis was undertaken alongside the smoking, nicotine, and pregnancy trial to compare NRT patches plus behavioral support to behavioral support alone, for pregnant women who smoked. RESULTS: At delivery, biochemically verified quit rates were slightly higher at 9.4% in the NRT group compared to 7.6% in the control group (odds ratio = 1.26, 95% CI = 0.82-1.96), at an increased cost of around £90 per participant. Higher costs in the NRT group were mainly attributable to the cost of NRT patches (mean = £46.07). The incremental cost-effectiveness ratio associated with NRT was £4,926 per quitter and a sensitivity analysis including only singleton births yielded an ICER of £4,156 per quitter. However, wide confidence intervals indicated a high level of uncertainty. CONCLUSIONS: Without a specific willingness to pay threshold, and due to high levels of statistical uncertainty, it is hard to determine the cost-effectiveness of NRT in this population. Furthermore, future research should address compliance issues, as these may dilute any potential effects of NRT, thus reducing the cost-effectiveness.

Quality of life among hazardous and harmful drinkers: EQ-5D over a 1-year follow-up period.

PURPOSE: To investigate the ability of the EQ-5D to discriminate between levels of alcohol risk in a large sample of hazardous and harmful drinkers, and to explore the relationship between transitions between alcohol risk levels and changes in EQ-5D up to 12 months. METHODS: This is a web-based randomised controlled trial evaluating a novel intervention for hazardous and harmful alcohol consumption. EQ-5D scores were compared among groups of drinkers at baseline (low/medium/high risk according to self-reported past week alcohol consumption), and changes in EQ-5D scores were estimated as a function of changes in alcohol consumption level. RESULTS: Baseline EQ-5D scores were dominated by problems with anxiety/depression, which increased with alcohol risk level, whilst high-risk drinkers also experienced more problems with physical HRQoL dimensions. However, the tool demonstrated a considerable ceiling effect. At follow-up, despite considerable reductions in alcohol consumption across the sample, significant changes in aggregated EQ-5D index scores were only observed for high-risk drinkers at baseline who reduced their drinking, with small improvements (0.04-0.06) compared to those who did not reduce. CONCLUSIONS: Our results suggest that the three-option EQ-5D may not be an optimal primary end point for measuring clinical and cost-effectiveness in randomised controlled trials of interventions among hazardous and harmful alcohol users, although further testing of the sensitivity of the tool in these populations is needed.

Alexander Technique Lessons, Acupuncture Sessions or usual care for patients with chronic neck pain (ATLAS): study protocol for a randomised controlled trial.

BACKGROUND: Chronic neck pain is a common condition in the adult population. More research is needed to evaluate interventions aiming to facilitate beneficial long-term change. We propose to evaluate the effect of Alexander Technique lessons and acupuncture in a rigorously conducted pragmatic trial with an embedded qualitative study. METHODS/DESIGN: We will recruit 500 patients who have been diagnosed with neck pain in primary care, who have continued to experience neck pain for at least three months with 28% minimum cut-off score on the Northwick Park Neck Pain Questionnaire (NPQ). We will exclude patients with serious underlying pathology, prior cervical spine surgery, history of psychosis, rheumatoid arthritis, ankylosing spondylitis, osteoporosis, haemophilia, cancer, HIV or hepatitis, or with alcohol or drug dependency currently or in the last 12 months, or actively pursuing compensation or with pending litigation.The York Trials Unit will randomly allocate participants using a secure computer-based system. We will use block randomisation with allocation to each intervention arm being unambiguously concealed from anyone who might subvert the randomisation process.Participants will be randomised in equal proportions to Alexander Technique lessons, acupuncture or usual care alone. Twenty 30-minute Alexander Technique lessons will be provided by teachers registered with the Society of Teachers of the Alexander Technique and twelve 50-minute sessions of acupuncture will be provided by acupuncturists registered with the British Acupuncture Council. All participants will continue to receive usual GP care.The primary outcome will be the NPQ at 12 months, with the secondary time point at 6 months, and an area-under-curve analysis will include 3, 6 and 12 month time-points. Adverse events will be documented. Potential intervention effect modifiers and mediators to be explored include: self-efficacy, stress management, and the incorporation of practitioner advice about self-care and lifestyle. Qualitative material will be used to address issues of safety, acceptability and factors that impact on longer term outcomes. DISCUSSION: This study will provide robust evidence on whether there are significant clinical benefits to patients, economic benefits demonstrating value for money, and sufficient levels of acceptability and safety. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15186354.

Developing a complex intervention for diet and activity behaviour change in obese pregnant women (the UPBEAT trial); assessment of behavioural change and process evaluation in a pilot randomised controlled trial.

BACKGROUND: Complex interventions in obese pregnant women should be theoretically based, feasible and shown to demonstrate anticipated behavioural change prior to inception of large randomised controlled trials (RCTs). The aim was to determine if a) a complex intervention in obese pregnant women leads to anticipated changes in diet and physical activity behaviours, and b) to refine the intervention protocol through process evaluation of intervention fidelity. METHODS: We undertook a pilot RCT of a complex intervention in obese pregnant women, comparing routine antenatal care with an intervention to reduce dietary glycaemic load and saturated fat intake, and increase physical activity. Subjects included 183 obese pregnant women (mean BMI 36.3 kg/m2). RESULTS: Compared to women in the control arm, women in the intervention arm had a significant reduction in dietary glycaemic load (33 points, 95% CI -47 to -20), (p < 0.001) and saturated fat intake (-1.6% energy, 95% CI -2.8 to -0. 3) at 28 weeks' gestation. Objectively measured physical activity did not change. Physical discomfort and sustained barriers to physical activity were common at 28 weeks' gestation. Process evaluation identified barriers to recruitment, group attendance and compliance, leading to modification of intervention delivery. CONCLUSIONS: This pilot trial of a complex intervention in obese pregnant women suggests greater potential for change in dietary intake than for change in physical activity, and through process evaluation illustrates the considerable advantage of performing an exploratory trial of a complex intervention in obese pregnant women before undertaking a large RCT. TRIAL REGISTRATION NUMBER: ISRCTN89971375.

Health-related quality of life in hospital inpatients with pressure ulceration: assessment using generic health-related quality of life measures.

The objective of this study was to determine the impact of pressure ulceration on health-related quality of life (HRQoL) and to undertake a pilot study for a future larger study. The study comprised two parts. First, data from a large UK prospective cohort study were analyzed and the HRQoL of 218 people with pressure ulcers was compared with that of 2,289 people without ulcers using the Short Form-36 (SF-36) questionnaire. After adjusting for age, sex, and comorbidities, patients with pressure ulceration had significantly lower scores for both the physical (coefficient=-3.12, p<0.001) and mental (coefficient=-1.50, p=0.04) component summary scores of the SF-36. Second, a small pilot study was conducted to explore use of other tools. HRQoL was assessed in six patients with and 16 patients without pressure ulcers using the SF-36, the EQ-5D and a pain visual analog scale. SF-36 scores indicated that patients with pressure ulcers had significantly poorer physical functioning (d=22.3, p=0.001), role limitations due to physical problems (d=12.9, p=0.02), and vitality (d=20.6, p=0.04) than those without. EQ-5D scores were also poorer for patients with pressure ulceration, for both the visual analog scale (d=19.2, p=0.02) and the index (d=0.29, p=0.08). Patients with pressure ulceration had more perceived pain than those without; however, this difference was of borderline significance (d=-23.9, p=0.06). Pressure ulceration therefore has an impact on HRQoL that is measurable and persists after adjusting for potential confounding.

Mothers without companionship during childbirth: an analysis within the Millennium Cohort Study.

BACKGROUND: Studies have highlighted the benefits of social support during labor but no studies focused on women who choose to be unaccompanied or who have no companion available at birth. Our goals were, first, to identify characteristics of women who are unaccompanied at birth and compare these to those who had support and, second, to establish whether or not being unaccompanied at birth is a risk marker for adverse maternal and infant health outcomes. METHODS: The sample comprised 16,610 natural mother-infant pairs, excluding women with planned cesarean sections in the Millennium Cohort Study. Multivariable regression models were used to examine, first, sociodemographic, cultural, socioeconomic, and pregnancy characteristics in relation to being unaccompanied and, second, being unaccompanied at birth in relation to labor and delivery outcomes, maternal health and health-related behaviors, parenting, and infant health and development. RESULTS: Mothers who were single (vs not single), multiparous (vs primiparous), of black or Pakistani ethnicity (vs white), from poor households (vs nonpoor), with low levels of education (vs high levels), and who did not attend antenatal classes (vs attenders) were at significantly higher risk of being unaccompanied at birth. Mothers unaccompanied at birth were more likely to have a preterm birth (vs term), an emergency cesarean section (vs spontaneous vaginal delivery) and spinal pain relief or a general anesthetic (vs no pain relief), a shorter labor, and lower satisfaction with life (vs high satisfaction) at 9 months postpartum. Their infants had significantly lower birthweight and were at higher risk of delayed gross motor development (vs normal development). CONCLUSIONS: Being unaccompanied at birth may be a useful marker of high-risk mothers and infants in need of additional support in the postpartum period and beyond.