Hyperemesis in Pregnancy Study: a pilot randomised controlled trial of midwife-led outpatient care.

OBJECTIVE: To assess the feasibility of implementing a complex intervention involving rapid intravenous rehydration and ongoing midwifery support as compared to routine in-patient care for women suffering from severe nausea and vomiting in pregnancy, (NVP)/hyperemesis gravidarum (HG). STUDY DESIGN: 53 pregnant women attending the Maternity Assessment Unit (MAU), Newcastle upon Tyne NHS Foundation Trust, Newcastle, UK with moderate-severe NVP, (as determined by a Pregnancy Unique Quantification of Emesis and Vomiting [PUQE] score ≥nine), consented to participate in this pilot randomised controlled trial (RCT). Subsequently 27 were randomised to the intervention group, 26 to the control group. Women in the intervention group received rapid rehydration (three litres Hartman's solution over 6h) and symptom relief on the MAU followed by ongoing midwifery telephone support. The control group were admitted to the antenatal ward for routine in-patient care. Quality of life (QoL) determined by SF36.V2 score and PUQE score were measured 7 days following randomisation. Completion rates, readmission rate, length of hospital stay and pregnancy outcomes data were collected. RESULTS: Groups were comparable at baseline. Questionnaire two return rate was disappointing, only 18 women in the control group (69%) and 13 women in the intervention groups (44%). Nonetheless there were no differences between groups on Day 7 in terms of QoL, mean PUQE score, satisfaction with care, obstetric and neonatal outcomes or readmission rates. However, total combined admission time was higher in the control group (94h versus 27h, p=0.001). CONCLUSIONS: This study suggests that day-case management plus ongoing midwifery support may be an effective alternative for treating women with severe NVP/HG. A larger trial is needed to determine if this intervention affects women's QoL.

Antenatal telephone support intervention with and without uterine artery Doppler screening for low risk nulliparous women: a randomised controlled trial.

BACKGROUND: The number of routine antenatal visits provided to low risk nulliparous women has been reduced in the UK, acknowledging this change in care may result in women being less satisfied with their care and having poorer psychosocial outcomes. The primary aim of the study was to investigate whether the provision of proactive telephone support intervention (TSI) with and without uterine artery Doppler screening (UADS) would reduce the total number of antenatal visits required. A secondary aim was to investigate whether the interventions affected psychological outcomes. METHODS: A three-arm randomised controlled trial involving 840 low risk nulliparous women was conducted at a large maternity unit in North East England. All women received antenatal care in line with current UK guidance. Women in the TSI group (T) received calls from a midwife at 28, 33 and 36 weeks and women in the telephone and Doppler group (T + D) received the TSI and additional UADS at 20 weeks' gestation. The main outcome measure was the total number of scheduled and unscheduled antenatal visits received after 20 weeks' gestation. RESULTS: The median number of unscheduled (n = 2.0), scheduled visits (n = 7.0) and mean number of total visits (n = 8.8) were similar in the three groups. The majority (67%) of additional antenatal visits were made to a Maternity Assessment Unit because of commonly occurring pregnancy complications. Additional TSI+/-UADS was not associated with differences in clinical outcomes, levels of anxiety, social support or satisfaction with care. There were challenges to the successful delivery of the telephone support intervention; 59% of women were contacted at 29 and 33 weeks gestation reducing to 52% of women at 37 weeks. CONCLUSIONS: Provision of additional telephone support (with or without UADS) in low risk nulliparous women did not reduce the number of unscheduled antenatal visits or reduce anxiety. This study provides a useful insight into the reasons why this client group attend for unscheduled visits. TRIAL REGISTRATION: ISRCTN62354584.

Using psychological theory to understand the clinical management of type 2 diabetes in Primary Care: a comparison across two European countries.

BACKGROUND: Long term management of patients with Type 2 diabetes is well established within Primary Care. However, despite extensive efforts to implement high quality care both service provision and patient health outcomes remain sub-optimal. Several recent studies suggest that psychological theories about individuals' behaviour can provide a valuable framework for understanding generalisable factors underlying health professionals' clinical behaviour. In the context of the team management of chronic disease such as diabetes, however, the application of such models is less well established. The aim of this study was to identify motivational factors underlying health professional teams' clinical management of diabetes using a psychological model of human behaviour. METHODS: A predictive questionnaire based on the Theory of Planned Behaviour (TPB) investigated health professionals' (HPs') cognitions (e.g., beliefs, attitudes and intentions) about the provision of two aspects of care for patients with diabetes: prescribing statins and inspecting feet.General practitioners and practice nurses in England and the Netherlands completed parallel questionnaires, cross-validated for equivalence in English and Dutch. Behavioural data were practice-level patient-reported rates of foot examination and use of statin medication. Relationships between the cognitive antecedents of behaviour proposed by the TPB and healthcare teams' clinical behaviour were explored using multiple regression. RESULTS: In both countries, attitude and subjective norm were important predictors of health professionals' intention to inspect feet (Attitude: beta = .40; Subjective Norm: beta = .28; Adjusted R2 = .34, p < 0.01), and their intention to prescribe statins (Attitude: beta = .44; Adjusted R2 = .40, p < 0.01). Individuals' self-reported intention did not predict practice-level performance of either clinical behaviour. CONCLUSION: Using the TPB, we identified modifiable factors underlying health professionals' intentions to perform two clinical behaviours, providing a rationale for the development of targeted interventions. However, we did not observe a relationship between health professionals' intentions and our proxy measure of team behaviour. Significant methodological issues were highlighted concerning the use of models of individual behaviour to explain behaviours performed by teams. In order to investigate clinical behaviours performed by teams it may be necessary to develop measures that reflect the collective cognitions of the members of the team to facilitate the application of these theoretical models to team behaviours.

Diet and dental erosion in young people in south-east Brazil.

BACKGROUND: The regular consumption of acidic foods and drinks may be associated with dental erosion, and soft drink consumption appears to be increasing both in developed and developing countries. Dentists are aware that an acidic diet can contribute to the development of erosion; however, there may be confusion within the profession concerning the general health message of eating five portions of fruits and vegetables each day. OBJECTIVE: The aim of this study was to investigate associations between dental erosion and the consumption of acidic foods and beverages in schoolchildren in south-east Brazil. The objective was to gather information, by means of a dietary questionnaire, on frequency of intake and patterns of consumption of acidic foods and drinks in a group of schoolchildren. The hypothesis was that the experience of dental erosion among the study sample was associated with the frequency and pattern of consumption of soft drinks, fruit juices, fruits, and yogurt. METHODS: A cross-sectional study was conducted in Três Corações, south-east Brazil. A sample of 458 schoolchildren, mean age 13.8 (SD 0.39) years, completed the study. Information about potential dietary risk factors for dental erosion was collected through a questionnaire survey completed by the schoolchildren. For the dental examinations, the subjects were examined for dental erosion in a school room. Associations between dental erosion and the variables under study were investigated through processes of bivariate and multivariate analyses. The statistical significance level was set at 5%. RESULTS: Analysis of the questionnaire surveys showed that the frequency of consumption of sugared carbonated drinks was the only variable independently associated with the erosive process, with subjects who had a daily consumption of such drinks having a greater likelihood of having erosion (P = 0.015, odds ratio 1.752, 95% confidence interval 1.116-2.750). CONCLUSIONS: Of all tested factors in this sample of schoolchildren the consumption of sugared carbonated drinks is most associated with dental erosion.

A method for clinically defining "improvers" in chronic pain studies.

AIMS: To test a measurement model based on clinicians' assessments of patient data that allows simple and confident clinical validation of any statistical or numerical technique designed to separate patients improving with treatment from those who are not, particularly for pain that shows large daily variation. METHODS: Diaries using daily visual analog scales (VAS) of pain intensity were obtained from 39 patients treated for chronic temporomandibular disorders. Three experienced clinicians visually assessed 39 VAS/time graphs. Criteria indicating improvement (general trend, height and apparent frequency of graph spikes) evolved over 3 assessments. The third assessment defined improvers visually. Numeric analyses considered the difference between first and last months of treatment for mean, area under the curve (AUC), and maximum VAS scores. Thresholds of 40%, 50%, or 60% pain reduction defined improvement numerically. Aggregate sensitivity and specificity was compared with visual definition to find the optimal threshold. RESULTS: Patients were defined visually as improvers, nonimprovers, and borderline cases. Interexaminer reliability for identifying improvers was good (k = 0.79). Mean VAS and AUC were highly correlated (r = 0.999). The optimal threshold of mean and maximum VAS relative to visual definition was 50% pain reduction. Cases defined as improvers by both mean and maximum agreed best with the visual definition (sensitivity 90%, specificity 84%). CONCLUSION: Visual assessment of VAS demonstrates distinct pain/time patterns that can validate numeric definition of complex pain recovery. No single numeric method can be guaranteed to give a clinically valid outcome.

Is untargeted educational outreach visiting delivered by pharmaceutical advisers effective in primary care? A pragmatic randomized controlled trial.

BACKGROUND: There is increasing evidence that clinical guidelines can lead to improvements in clinical care. However, they are not self-implementing. While educational outreach visits may improve prescribing behaviour, the effectiveness of routine delivery of these visits by existing pharmaceutical advisers is unknown. METHODS: Within a pragmatic randomized controlled trial, involving all general practices in two primary care trusts (PCTs), routine methods were used to distribute guidelines for the choice of antidepressants for the management of depression. Intervention practices were offered two visits (most accepted only one) by their PCT pharmaceutical adviser who had been trained in the techniques of outreach visiting. Intervention practices were visited regardless of whether they had prior problems with prescribing ('untargeted' visits). The intervention was evaluated using level three prescribing analysis and cost (PACT) data for antidepressant drugs for the six months during which the intervention was delivered and the subsequent twelve months. RESULTS: Across the 72 study practices there was no significant impact of the intervention on usage of any group of antidepressant drugs. CONCLUSION: The routine use of untargeted educational outreach visiting delivered by existing pharmaceutical advisers may not be a worthwhile strategy.

A pragmatic cluster randomised controlled trial of a Diabetes REcall And Management system: the DREAM trial.

BACKGROUND: Following the introduction of a computerised diabetes register in part of the northeast of England, care initially improved but then plateaued. We therefore enhanced the existing diabetes register to address these problems. The aim of the trial was to evaluate the effectiveness and efficiency of an area wide 'extended,' computerised diabetes register incorporating a full structured recall and management system, including individualised patient management prompts to primary care clinicians based on locally-adapted, evidence-based guidelines. METHODS: The study design was a pragmatic, cluster randomised controlled trial, with the general practice as the unit of randomisation. Set in 58 general practices in three Primary Care Trusts in the northeast of England, the study outcomes were the clinical process and outcome variables held on the diabetes register, patient-reported outcomes, and service and patient costs. The effect of the intervention was estimated using generalised linear models with an appropriate error structure. To allow for the clustering of patients within practices, population averaged models were estimated using generalized estimating equations. RESULTS: Patients in intervention practices were more likely to have at least one diabetes appointment recorded (OR 2.00, 95% CI 1.02, 3.91), to have a recording of a foot check (OR 1.87, 95% CI 1.09, 3.21), have a recording of receiving dietary advice (OR 2.77, 95% CI 1.22, 6.29), and have a recording of blood pressure (BP) (OR 2.14, 95% CI 1.06, 4.36). There was no difference in mean HbA1c or BP levels, but the mean cholesterol level in patients from intervention practices was significantly lower (-0.15 mmol/l, 95% CI -0.25, -0.06). There were no differences in patient-reported outcomes or in patient-reported use of drugs, or uptake of health services. The average cost per patient was not significantly different between the intervention and control groups. Costs incurred in administering the system at the register and in general practice were in addition to these. CONCLUSION: This study has shown benefits from an area-wide, computerised diabetes register incorporating a full structured recall and individualised patient management system. However, these benefits were achieved at a cost. In future, these costs may fall as electronic data exchange becomes a reliable reality. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number (ISRCTN) Register, ISRCTN32042030.