Nancy Briggs

Early molecular response and female sex strongly predict stable undetectable BCR-ABL1, the criteria for imatinib discontinuation in patients with CML.

Recent studies have demonstrated that some patients with chronic myeloid leukemia (CML) can maintain remission after discontinuation of imatinib. A prerequisite is stable, undetectable BCR-ABL1. It is not known how many patients achieve this response or the factors associated with its achievement. We examined 423 de novo imatinib-treated patients to determine the cumulative incidence of achieving the discontinuation criteria as defined in the CML8 study (≥2 years of undetectable BCR-ABL1 [Stable MR(4.5)]), and predictive factors. After 8 years of imatinib, the cumulative incidence of Stable MR(4.5) was 36.5%. Therefore, 9% to 15% of first-line imatinib-treated patients would maintain remission after discontinuation. The BCR-ABL1 level at 3 months and factors at diagnosis were examined for association with Stable MR(4.5): Sokal risk, age, sex, and assigned imatinib dose. The only independent predictors were female sex (54.4% vs 27.2%; P = .018) and the 3-month BCR-ABL1 (P < .001). The highest cumulative incidence of Stable MR(4.5) after 8 years was 78.2% for patients with BCR-ABL1 ≤ 0.10%(IS) at 3 months (n = 38). Time to major molecular response (MMR) influenced the time to reach Stable MR(4.5) (P < .001), suggesting slower dynamics of response with a delayed MMR. The findings justify the focus on rapid reduction of BCR-ABL1 as a strategy to maximize potential suitability for imatinib discontinuation studies. The Iris trial was registered at http://www.clinicaltrials.gov as NCT00006343. The Tops trial was registered at http://www.clinicaltrials.gov as NCT00124748. The TIDEL I trial was registered at www.ANZCTR.org.au as ACTRN12607000614493. The TIDEL II trial was registered at www.ANZCTR.org.au as ACTRN12607000325404.

Prevalence, awareness, treatment, and control of hypertension in rural China: results from Shandong Province.

Objectives Hypertension is an important public health problem in rural China with a rapidly increasing prevalence noted in recent years. This study estimates the prevalence, awareness, treatment and control of hypertension in a rural population in Shandong Province, China. Methods A cross-sectional study was conducted in rural Shandong Province, China, in April 2007 using multistage cluster sampling. A total of 16 364 rural residents aged 25 years and more were interviewed and examined. Two blood pressure (BP) measurements were obtained using a standardized mercury sphygmomanometer after a 5-min seated rest. Information on history of hypertension was obtained using a standard questionnaire. Hypertension was defined as mean systolic BP (SBP) at least 140 mmHg and/or diastolic BP (DBP) at least 90 mmHg, and/or self-reported current use of antihypertensive medication. Results Overall, 43.8% of the population had hypertension. Among hypertensive patients, only 26.2% were aware of their hypertension, 22.2% were currently undergoing antihypertensive treatment, and 3.9% achieved BP control (<140/90 mmHg). Lack of knowledge about hypertension and the importance of BP control were associated with poor compliance with nonpharmacological and pharmacological treatments. Conclusions In the study population, the prevalence of hypertension is high, but levels of awareness, treatment and control are unacceptably low. There is an urgent need for comprehensive integrated strategies to improve prevention, detection and treatment of hypertension in rural areas in Shandong Province, China.

Adjustment to infertility: the role of intrapersonal and interpersonal resources/vulnerabilities

BACKGROUND Great variability exists in the degree of adjustment to infertility, which in turn is known to influence wellbeing. The main objective of this study is to identify intrapersonal [neuroticism, adult attachment style (AAS), perceived internal control, meaning of parenthood and intrinsic religiosity] and interpersonal (social support and marital adjustment) associates of adjustment to infertility. METHOD A cross-sectional analysis of 85 consecutive heterosexual women, attending three infertility clinics in northern India during July 2005-March 2006, participated in the study. A range of scales were used to measure the intrapersonal and interpersonal attributes. The degree of adjustment to infertility was assessed using the Fertility Adjustment Scale. The data were analysed using multiple regression. RESULTS The intrapersonal model (49.3%) explained a larger proportion of variance than did the interpersonal model (28.4%). Perception of children as necessary for marital completion, and the avoidance type of AAS was associated with poorer adjustment and constituted intrapersonal vulnerabilities. In contrast, intrinsic religiosity, sexual satisfaction and familial support were associated with better adjustment and were identified as helpful intrapersonal and interpersonal coping resources. CONCLUSIONS The findings of the study highlight the merit of understanding intra- and interpersonal attributes for achieving better wellbeing outcomes. These findings would also prove valuable for researchers and practioners involved in designing and implementing psychosocial interventions.

Factors and perceptions that influence women's decisions to have a single embryo transferred.

The aim of this study was to identify factors that inhibit or promote the adoption of single embryo transfer (SET). A cohort of 163 women patients receiving IVF/intracytoplasmic sperm injection treatment, comprising 87 women choosing SET and 63 women choosing double embryo transfer (DET), were interviewed using a structured questionnaire. The data were compared using logistic regression analysis. Confidence in the chance of pregnancy with SET, younger age and first treatment were predictive of a decision for SET. Preference for a healthy and singleton pregnancy was predictive but perceptions of the incidence or risk of multiple gestation were not. Factors such as a sense of time urgency and past experience of treatment were significant and predictive of diminished choice of SET. The clinic doctor was an important influencing factor. The results of this study confirm that improved pregnancy rates in SET coupled with an official clinic policy to promote SET in younger, first cycle patients influenced many women to choose SET. However, repeated treatment, advancing age and urgency to become pregnant are factors that moderate a womans choice for SET.

The cost-effectiveness of point of care testing in a general practice setting: results from a randomised controlled trial

BackgroundWhile point of care testing (PoCT) for general practitioners is becoming increasingly popular, few studies have investigated whether it represents value for money. This study aims to assess the relative cost-effectiveness of PoCT in general practice (GP) compared to usual testing practice through a pathology laboratory.MethodsA cost-effectiveness analysis based on a randomized controlled trial with 4,968 patients followed up for 18 months and fifty-three general practices in urban, rural and remote locations across three states in Australia.The incremental costs and health outcomes associated with a clinical strategy of PoCT for INR, HbA1c, lipids, and ACR were compared to those from pathology laboratory testing. Costs were expressed in year 2006 Australian dollars. Non-parametric bootstrapping was used to generate 95% confidence intervals.ResultsThe point estimate of the total direct costs per patient to the health care sector for PoCT was less for ACR than for pathology laboratory testing, but greater for INR, HbA1c and Lipids, although none of these differences was statistically significant. PoCT led to significant cost savings to patients and their families. When uncertainty around the point estimates was taken into account, the incremental cost-effectiveness ratio (ICER) for PoCT was found to be unfavourable for INR, but somewhat favourable for ACR, while substantial uncertainty still surrounds PoCT for HbA1c and Lipids.ConclusionsThe decision whether to fund PoCT will depend on the price society is willing to pay for achievement of the non-standard intermediate outcome indicator.Trial registrationAustralian New Zealand Clinical Trial Registry ACTRN12605000272695

Early cerebral oxygen extraction and the risk of death or sonographic brain injury in very preterm infants.

OBJECTIVE To evaluate the relationship between cerebral fractional tissue oxygen extraction (cFTOE), a measure of oxygen delivery-consumption equilibrium, and the risk of early poor outcome in very preterm infants. STUDY DESIGN Cerebral blood flow, tissue oxygenation index (by near-infrared spectroscopy), and arterial oxygen content were measured, and cerebral oxygen delivery, consumption, and cFTOE were calculated at 3 intervals in the first 72 hours of life in infants ≤ 30 weeks gestational age (GA). A receiver operating characteristic curve was derived with an a priori defined dichotomized outcome of good or poor, defined as death or sonographic brain injury (grade ≥ II intraventricular hemorrhage) by day 7. RESULTS Seventy-one infants were enrolled, with a mean (SD) GA of 27 (2) weeks. cFTOE demonstrated better discrimination for the study outcome at <24 hours of age than at 48 or 72 hours of age (P = .01). The area under the curve for cFTOE at the initial measurement was no different from that for GA alone (0.87; 95% CI, 0.77-0.95 vs 0.81; 95% CI, 0.69-0.92), but the combined measure of cFTOE and GA had better discrimination (0.96; 95% CI, 0.91-1.0) than either cFTOE (P = .03) or GA (P = .016) alone. A cFTOE of 0.4 had a sensitivity of 82% and specificity of 75% for risk of early poor outcome. CONCLUSION Elevated cFTOE values are associated with increased risk of early poor outcome in very preterm infants. Its predictive value is further improved with the addition of GA.

Changes in affect and state anxiety across an in vitro fertilization/intracytoplasmic sperm injection cycle

OBJECTIVE To identify pattern of change in average positive affect (PA), negative affect (NA), and state anxiety (St ANX) across three biological end points of an IVF/intracytoplasmic sperm injection (ICSI) procedure and to examine whether the pattern varied across sociodemographic and biomedical subgroups. DESIGN Longitudinal follow-up study of PA, NA, and St ANX at three different time points: before start of study, before ovum pick-up (OPU), and before embryo transfer. SETTING Three infertility centers in northern India. PATIENT(S) Baseline data were obtained from a consecutive sample of 85 women. However, final analysis was done on data obtained from 74 women who reached the embryo transfer stage and completed the questionnaires at both OPU and embryo transfer. INTERVENTION(S) The PA, NA, and St ANX scores. MAIN OUTCOME MEASURE(S) Change in PA, NA, and St ANX scores at three stages of the treatment: baseline (T(0)), before OPU (T(1)), before embryo transfer (T(2)). RESULT(S) The PA scores before OPU and embryo transfer were significantly lower than those at baseline. The mean NA and St ANX scores before OPU and embryo transfer were significantly higher than baseline scores. Furthermore, mean NA before embryo transfer was significantly higher than mean NA before OPU. The PA and St ANX scores showed statistically insignificance within cycle variations. Furthermore, the mean PA and St ANX for a subgroup of women who reported more than moderate level of burden were less variable. CONCLUSION(S) The OPU and embryo transfer stages are more stressful than the baseline stage for most women across various sociodemographic and biomedical subgroups. Women with more than a moderate level of financial burden were relatively more stable.

Exploring the need to update lung age equations

AIMS A renewed interest in lung age is evidenced by recent smoking cessation publications. This research compares the original Morris lung age equations (1985) with contemporary Australian lung age equations. METHODS Both lung age equations were applied to the spirometry results of two sub-groups (never-smokers n=340, and current smokers n=50) from an independent dataset. Means of both lung age estimates were compared to the mean of the chronological age of each group by paired Students t-test. RESULTS The Morris lung age estimates were paradoxically lower (younger) than chronological age in both groups. The new Australian equation produced lung age estimates that were equivalent to chronological age in the never-smoker group and significantly higher (older) than chronological age in the current smoker group. CONCLUSIONS These results strongly suggest that the Morris lung age equations are in need of review. The use of contemporary lung age equations may translate into greater success for smoking cessation programs. The new Australian equations seem to possess internal validity.

Does spirometry training in general practice improve quality and outcomes of asthma care

OBJECTIVE Clinical asthma guidelines recommend spirometry for asthma diagnosis, but there is inconsistent evidence about benefits to patients in using it for ongoing management. Our aim was to determine whether training in the use of spirometry for management of asthma provided better health outcomes and improved the quality of care in the primary care setting. DESIGN Pragmatic, cluster randomized controlled trial. SETTING General practices in two states of Australia. PARTICIPANTS Forty practices and 397 adults with asthma. INTERVENTION The staff of 26 intervention practices received comprehensive spirometry training. Fourteen control practices provided usual care. MAIN OUTCOME MEASURES Primary outcome measures were quality of life, self-reported asthma symptoms and lung function. Secondary measures related to the process of care (e.g. performance of spirometry, preparation of a written asthma action plan) and patient and general practitioner rating of the acceptability and usefulness of spirometry. RESULTS There were no statistically significant differences between the groups at 12 months for quality of life (mean difference = -0.23; 95% CI: -0.44, -0.01), days off work (rate ratio = 1.52; 95% CI: 0.91, 2.54), exacerbations (rate ratio = 1.09; 95% CI: 0.85, 1.41), asthma on waking (rate ratio = 1.21; 95% CI: 0.79, 1.85), nocturnal asthma (rate ratio = 0.98; 95% CI: 0.63, 1.51) and post-bronchodilator FEV(1)/FVC ratio (mean difference = -0.01, 95% CI: -0.03, 0.02). There was no improvement in the quality of care provided. CONCLUSIONS Training in spirometry did not result in any measurable improvement in the use of spirometry, quality of management of asthma or patient outcomes in primary care.

The relationship between urinary melatonin metabolite excretion and posttraumatic symptoms following traumatic injury

BACKGROUND Associations between 24-hour urinary 6-sulphatoxy melatonin excretion and symptoms of posttraumatic stress disorder were assessed 2 days, 1 month and 6 months after traumatic injury requiring hospitalisation. METHODS Forty-eight participants were recruited following an admission to hospital for an acute traumatic injury. They completed assessments 48h after the accident, 1 month and 6 months later. A 24-hour urine collection was initiated the morning before questionnaires were administered. PTSD symptoms and caseness was determined using the Impact of Event Scale (IES-R) and the Clinician Administered PTSD Scale respectively. Urinary 6-sulphatoxy melatonin was assayed by radioimmunoassay. RESULTS Mean age of participants was 34 years (SD=12.72) and 75% were males. Ten (27%) participants met the criteria for PTSD 1 month post trauma and 6 (21%) met the criteria for PTSD at 6 months. Four of the six (67%) participants with PTSD at 6 months were also positive for major depression. Significant negative correlations were found between 6-sulphatoxy melatonin excretion at day 2 and all subscales and total score of the IES-R at the six month assessment. Controlling for depression, every one unit decrease in 6-sulphatoxy melatonin excretion was associated with a 13% increase in PTSD risk at six months (OR=1.13, 95% CI 1.00-1.27). However, this association was lost when self-reported pain, gender and employment was added to the model (OR=1.11, 0.93-1.32). CONCLUSION This study provides preliminary data suggesting disrupted melatonin levels in the first 48h following trauma may place individuals at increased risk of PTSD.