Adolescence is a key period for studying the development of depression, with studies in Europe and North America showing a pattern of elevated risk that begins in early adolescence and continues to increase as adolescents age. Few studies have examined the course of adolescent depression and associated risk factors in low and middle-income countries. This longitudinal cohort study examined depression symptom trajectories and risk factors in a sample of socio-economically disadvantaged adolescents in Chile (n = 2,508). Data were collected over an 18-month period as part of a clinical trial for secondary students aged 12 to 18 (median age 14). Clinical levels of depression were prevalent in this sample at baseline (35% for girls and 28% for boys); yet latent growth models of symptom trajectories revealed a pattern of decreasing symptoms over time. There was evidence of an anxiety-depression developmental pathway for girls, with elevated anxiety levels initially predicting poorer depression outcomes later on. Poor problem-solving skills were associated with initial depression levels but did not predict the course of depressive symptoms. Critically, the declining symptom trajectories raise important methodological issues regarding the effects of repeated assessment in longitudinal studies.
To compare the cost-effectiveness of PhysioDirect with usual physiotherapy care for patients with musculoskeletal problems.
(1) Cost-consequences comparing cost to the National Health Service (NHS), to patients, and the value of lost productivity with a range of outcomes. (2) Cost-utility analysis comparing cost to the NHS with Quality-Adjusted Life Years (QALYs).
Four physiotherapy services in England.
Adults (18+) referred by their general practitioner or self-referred for physiotherapy.
PhysioDirect involved telephone assessment and advice followed by face-to-face care if needed. Usual care patients were placed on a waiting list for face-to-face care.
Primary and secondary outcomes
Primary clinical outcome: physical component summary from the SF-36v2 at 6 months. Also included in the cost-consequences: Measure Yourself Medical Outcomes Profile; a Global Improvement Score; response to treatment; patient satisfaction; waiting time. Outcome for the cost-utility analysis: QALYs.
2249 patients took part (1506 PhysioDirect; 743 usual care). (1) Cost-consequences: there was no evidence of a difference between the two groups in the cost of physiotherapy, other NHS services, personal costs or value of time off work. Outcomes were also similar. (2) Cost-utility analysis based on complete cases (n=1272). Total NHS costs, including the cost of physiotherapy were higher in the PhysioDirect group by £19.30 (95% CI −£37.60 to £76.19) and there was a QALY gain of 0.007 (95% CI −0.003 to 0.016). The incremental cost-effectiveness ratio was £2889 and the net monetary benefit at λ=£20 000 was £117 (95% CI −£86 to £310).
PhysioDirect may be a cost-effective alternative to usual physiotherapy care, though only with careful management of staff time. Physiotherapists providing the service must be more fully occupied than was possible under trial conditions: consideration should be given to the scale of operation, opening times of the service and flexibility in the methods used to contact patients.
economic evaluation; physiotherapy; telehealth; PRIMARY CARE; costs & cost analysis
The Nurse Family Partnership programme was developed in the USA where it is made available to pregnant young mothers in some socially deprived geographic areas. The related Family Nurse Partnership programme was introduced in England by the Department of Health in 2006 with the aim of improving outcomes for the health, wellbeing and social circumstances of young first-time mothers and their children.
Methods / design
This multi-centre individually randomised controlled trial will recruit 1600 participants from 18 Primary Care Trusts in England, United Kingdom. The trial will evaluate the effectiveness of Family Nurse Partnership programme and usual care versus usual care for nulliparous pregnant women aged 19 or under, recruited by 24 weeks gestation and followed until the child’s second birthday. Data will be collected from participants at baseline, 34-36 weeks gestation, 6, 12, 18 and 24 months following birth. Routine clinical data will be collected from maternity, primary care and hospital episodes statistics. Four primary outcomes are to be reported from the trial: birth weight; prenatal tobacco use; child emergency attendances and/or admissions within two years of birth; second pregnancy within two years of first birth.
This trial will evaluate the effectiveness and cost effectiveness of the Family Nurse Partnership in England. The findings will provide evidence on pregnancy and early childhood programme outcomes for policy makers, health professionals and potential recipients in three domains (pregnancy and birth, child health and development, and parental life course and self-sufficiency) up to the child’s second birthday.
Trial registration number: ISRCTN 23019866
Pregnancy in adolescence; Prenatal care; Maternal health; Home visiting; Birth weight; Smoking cessation; Child maltreatment; Family nurse partnership; Early years prevention; Randomised controlled trial
The naturally-occurring omega (ω)-3 polyunsaturated fatty acid (PUFA) eicosapentaenoic acid (EPA) reduces colorectal adenoma (polyp) number and size in patients with familial adenomatous polyposis. The safety profile and potential cardiovascular benefits associated with ω-3 PUFAs make EPA a strong candidate for colorectal cancer (CRC) chemoprevention, alone or in combination with aspirin, which itself has recognized anti-CRC activity. Colorectal adenoma number and size are recognized as biomarkers of future CRC risk and are established as surrogate end-points in CRC chemoprevention trials.
The seAFOod Polyp Prevention Trial is a randomized, double-blind, placebo-controlled, 2 × 2 factorial ‘efficacy’ study, which will determine whether EPA prevents colorectal adenomas, either alone or in combination with aspirin. Participants are 55–73 year-old patients, who have been identified as ‘high risk’ (detection of ≥5 small adenomas or ≥3 adenomas with at least one being ≥10 mm in diameter) at screening colonoscopy in the English Bowel Cancer Screening Programme (BCSP). Exclusion criteria include the need for more than one repeat endoscopy within the three-month BCSP screening period, malignant change in an adenoma, regular use of aspirin or non-aspirin non-steroidal anti-inflammatory drugs, regular use of fish oil supplements and concomitant warfarin or anti-platelet agent therapy. Patients are randomized to either EPA-free fatty acid 1 g twice daily or identical placebo AND aspirin 300 mg once daily or identical placebo, for approximately 12 months. The primary end-point is the number of participants with one or more adenomas detected at routine one-year BCSP surveillance colonoscopy. Secondary end-points include the number of adenomas (total and ‘advanced’) per patient, the location (left versus right colon) of colorectal adenomas and the number of participants re-classified as ‘intermediate risk’ for future surveillance. Exploratory end-points include levels of bioactive lipid mediators such as ω-3 PUFAs, resolvin E1 and PGE-M in plasma, urine, erythrocytes and rectal mucosa in order to gain insights into the mechanism(s) of action of EPA and aspirin, alone and in combination, as well as to discover predictive biomarkers of chemopreventive efficacy. The recruitment target is 904 patients.
Current Controlled Trials ISRCTN05926847
Aspirin; Colorectal adenoma; Colorectal cancer; Eicosapentaenoic acid; Omega-3 polyunsaturated fatty acid
Self-harm is common in adolescents, but it is often unreported and undetected. Available screening tools typically ask directly about self-harm and suicidal ideation. Although in an ideal world, direct enquiry and open discussion around self-harm would be advocated, non-psychiatric professionals in community settings are often reluctant to ask about this directly and disclosure can be met with feeling of intense anxiety. Training non-specialist staff to directly ask about self-harm has limited effects suggesting that alternative approaches are required. This study investigated whether a targeted analysis of negative emotions and self-esteem could identify young adolescents at risk of self-harm in community settings.
Data were collected as part of a clinical trial from young people in school years 8–11 (aged 12–16) at eight UK secondary schools (N = 4503 at baseline, N = 3263 in prospective analysis). The Short Mood and Feelings Questionnaire, Revised Child Anxiety and Depression Scale, Rosenberg Self-Esteem Scale, personal failure (Children’s Automatic Thoughts Scale), and two items on self-harm were completed at baseline, 6 and 12 months.
Following a process of Principal Components Analysis, item reduction, and logistic regression analysis, three internally reliable factors were identified from the original measures that were independently associated with current and future self-harm; personal failure (3 items), physical symptoms of depression/anxiety (6 items), positive self-esteem (5 items). The summed score of these 14 items had good accuracy in identifying current self-harm (AUC 0.87 girls, 0.81 boys) and at six months for girls (0.81), and fair accuracy at six months for boys (AUC 0.74) and 12 months for girls (AUC 0.77).
A brief and targeted assessment of negative emotions and self-esteem, focusing on factors that are strongly associated with current and future self-harm, could potentially be used to help identify adolescents who are at risk in community settings. Further research should assess the psychometric properties of the items identified and test this approach in more diverse community contexts.
Self-harm; Screening; Adolescents; Negative emotions; Self-esteem
Many children do not meet physical activity (PA) guidelines. Extracurricular programmes could provide a mechanism to increase the PA levels of primary-school-aged children. Teaching assistants (TAs) are a valuable resource in all UK primary schools and could be trained to delivery after-school PA programmes. The aim of this feasibility study is to examine whether the Action 3:30 PA intervention, which is delivered by TAs, could be effective in increasing the PA of Year 5 and 6 children.
A feasibility trial will be conducted in 20 primary schools. Schools will be randomly assigned to intervention or control arms. Intervention schools will receive a 25-hour TA training programme for two TAs, a first-aid certificate course for two TAs; ongoing TA support; 40 one-hour session plans that can be delivered by TAs; Action 3:30 clubs that run twice a week for 20 weeks; and ten sets of parent information sheets that are distributed biweekly.
All measures will be assessed at baseline (Time 0), at the end of the intervention period (Time 1) and four months after the intervention has ended (Time 2). As this is a feasibility study, our primary interest is in estimating the recruitment of schools and children, adherence to the intervention, and completeness of data collection for outcomes and costs.
As the most likely primary outcome measure in a future definitive trial will be accelerometer-determined minutes of moderate-to-vigorous PA (MVPA) per day, participants will wear accelerometers for five days (including two weekend days). Several psychosocial variables that could act as mediators in a future trial will be assessed via a questionnaire. Process evaluations of the session attendance, perceived enjoyment and perceived exertion will be assessed during the intervention. At the end of the intervention period, qualitative assessments will be conducted to identify how the programme could be improved before proceeding to a larger trial.
The goal of the feasibility trial is to assess the potential of this innovative intervention approach and provide all the information necessary to design a cluster randomized controlled trial.
Children; Feasibility trial; Intervention; Physical activity; Teaching assistant
Instrumental deliveries are commonly performed in the United Kingdom and Ireland, with rates of 12 – 17% in most centres. Knowing the exact position of the fetal head is a pre-requisite for safe instrumental delivery. Traditionally, diagnosis of the fetal head position is made on transvaginal digital examination by delineating the suture lines of the fetal skull and the fontanelles. However, the accuracy of transvaginal digital examination can be unreliable and varies between 20% and 75%. Failure to identify the correct fetal head position increases the likelihood of failed instrumental delivery with the additional morbidity of sequential use of instruments or second stage caesarean section. The use of ultrasound in determining the position of the fetal head has been explored but is not part of routine clinical practice.
A multi-centre randomised controlled trial is proposed. The study will take place in two large maternity units in Ireland with a combined annual birth rate of 13,500 deliveries. It will involve 450 nulliparous women undergoing instrumental delivery after 37 weeks gestation. The main outcome measure will be incorrect diagnosis of the fetal head position. A study involving 450 women will have 80% power to detect a 10% difference in the incidence of inaccurate diagnosis of the fetal head position with two-sided 5% alpha.
It is both important and timely to evaluate the use of ultrasound to diagnose the fetal head position prior to instrumental delivery before routine use can be advocated. The overall aim is to reduce the incidence of incorrect diagnosis of the fetal head position prior to instrumental delivery and improve the safety of instrumental deliveries.
Current Controlled Trials ISRCTN72230496
Fetal head position; Second stage of labour; Intrapartum ultrasound; Randomised controlled trial
Many adolescent girls do not engage in sufficient physical activity (PA). This study examined the feasibility of conducting a cluster randomized controlled trial (RCT) to evaluate an after-school dance program to increase PA among 11–12 year old girls in Bristol, UK.
Three-arm, cluster RCT. Three secondary schools were assigned to intervention arm. Intervention participants received a 9-week dance program with 2, 90-minute dance classes per week. Participants at 2 control schools received incentives for data collection. Participants at 2 additional control schools received incentives and a delayed dance workshop. Accelerometer data were collected at baseline (time 0), during the last week of the dance program (time 1) and 20 weeks after the start of the study (time 2). Weekly attendance, enjoyment and perceived exertion were assessed in intervention participants. Post-study qualitative work was conducted with intervention participants and personnel.
40.1% of girls provided consent to be in the study. The mean number of girls attending at least one dance session per week ranged from 15.4 to 25.9. There was greater number of participants for whom accelerometer data were collected in control arms. The mean attendance was 13.3 sessions (maximum = 18). Perceived exertion ratings indicated that the girls did not find the sessions challenging. The dance teachers reported that the program content would benefit from revisions including less creative task time, a broader range of dance genres and improved behavioral management policies. At time 2, the 95% confidence intervals suggest between 5 and 12 minutes more weekday MVPA in the intervention group compared with the control incentives only group, and between 6 minutes fewer and 1 minute more compared with the control incentives plus workshop group. Between 14 and 24 schools would be required to detect a difference of 10 minutes in mean weekday MVPA between intervention and control groups.
It is possible to recruit 11–12 year old girls to participate in an after-school dance study. An after-school dance intervention has potential to positively affect the PA levels of 11–12 year old girls but an adequately powered RCT is required to test this intervention approach.
In developed countries, primary health care increasingly involves the care of patients with multiple chronic conditions, referred to as multimorbidity.
To describe the epidemiology of multimorbidity and relationships between multimorbidity and primary care consultation rates and continuity of care.
Design of study
Retrospective cohort study.
Random sample of 99 997 people aged 18 years or over registered with 182 general practices in England contributing data to the General Practice Research Database.
Multimorbidity was defined using two approaches: people with multiple chronic conditions included in the Quality and Outcomes Framework, and people identified using the Johns Hopkins University Adjusted Clinical Groups (ACG®) Case-Mix System. The determinants of multimorbidity (age, sex, area deprivation) and relationships with consultation rate and continuity of care were examined using regression models.
Sixteen per cent of patients had more than one chronic condition included in the Quality and Outcomes Framework, but these people accounted for 32% of all consultations. Using the wider ACG list of conditions, 58% of people had multimorbidity and they accounted for 78% of consultations. Multimorbidity was strongly related to age and deprivation. People with multimorbidity had higher consultation rates and less continuity of care compared with people without multimorbidity.
Multimorbidity is common in the population and most consultations in primary care involve people with multimorbidity. These people are less likely to receive continuity of care, although they may be more likely to gain from it.
chronic disease; comorbidity; family practice; primary health care; outcome and process assessment (healthcare); prevalence
Standards for the reporting of factorial randomised trials remain to be established. We aimed to review the quality of reporting of methodological aspects of published factorial trials of complex interventions in community settings.
We searched MEDLINE, EMBASE, PsychInfo and the Cochrane Controlled Trials Register to identify factorial randomised trials of complex interventions in community settings from January 2000 to August 2009. We also conducted a citation search of two review papers published in 2003. Data were extracted by two reviewers on 22 items relating to study design, analysis and presentation.
We identified 5941 unique titles, from which 116 full papers were obtained and 76 were included in the review. The included trials reflected a broad range of target conditions and types of intervention. The median sample size was 400 (interquartile range 191-1001). Most (88%) trials employed a 2 × 2 factorial design. Few trials (21%) explicitly stated the rationale for using a factorial design. Reporting of aspects of design, analysis or presentation specific to factorial trials was variable, but there was no evidence that reporting of these aspects was different for trials published before or after 2003. However, for CONSORT items that apply generally to the reporting of all trials, there was some evidence that later studies were more likely to report employing an intention-to-treat (ITT) approach (78% vs 52%), present appropriate between-group estimates of effect (88% vs 63%), and present standard errors or 95% confidence intervals for such estimates (78% vs 56%). Interactions between interventions and some measure of the precision associated with such effects were reported in only 14 (18%) trials.
Reports of factorial trials of complex interventions in community settings vary in the amount of information they provide regarding important methodological aspects of design and analysis. This variability supports the extension of CONSORT guidelines to include the specific reporting of factorial trials.
Depression is common and can have devastating effects on the life of adolescents. Psychological interventions are the first-line for treating or preventing depression among adolescents. This proposal aims to evaluate a school-based, universal psychological intervention to reduce depressive symptoms among student's aged 13-14 attending municipal state secondary schools in Santiago, Chile.
This is a cluster randomised controlled trial with schools as the main clusters. We compared this intervention with a control group in a study involving 22 schools, 66 classes and approximately 2,600 students. Students in the active schools attended 11 weekly and 3 booster sessions of an intervention based on cognitive-behavioural models. The control schools received their usual but enhanced counselling sessions currently included in their curriculum. Mean depression scores and indicators of levels of functioning were assessed at 3 and 12 months after the completion of the intervention in order to assess the effectiveness of the intervention. Direct and indirect costs were measured in both groups to assess the cost-effectiveness of this intervention.
As far as we are aware this is the first cluster randomised controlled trial of a school intervention for depression among adolescents outside the Western world.
Depression in adolescents is a significant problem that impairs everyday functioning and increases the risk of severe mental health disorders in adulthood. Relatively few adolescents with depression are identified and referred for treatment indicating the need to investigate alternative preventive approaches.
A pragmatic cluster randomised controlled trial evaluating the effectiveness of a school based prevention programme on symptoms of depression in "high risk" adolescents (aged 12-16). The unit of allocation is year groups (n = 28) which are assigned to one of three conditions: an active intervention based upon cognitive behaviour therapy, attention control or treatment as usual. Assessments will be undertaken at screening, baseline, 6 months and 12 months. The primary outcome measure is change on the Short Mood and Feeling Questionnaire at 12 months. Secondary outcome measures will assess changes in negative thoughts, self esteem, anxiety, school connectedness, peer attachment, alcohol and substance misuse, bullying and self harm.
As of August 2010, all 28 year groups (n = 5023) had been recruited and the assigned interventions delivered. Final 12 month assessments are scheduled to be completed by March 2011.
Depression is one of the most common reasons for consulting a General Practitioner (GP) within the UK. Whilst antidepressants have been shown to be clinically effective, many patients and healthcare professionals would like to access other forms of treatment as an alternative or adjunct to drug therapy for depression. A recent systematic review presented some evidence that physical activity could offer one such option, although further investigation is needed to test its effectiveness within the context of the National Health Service.
The aim of this paper is to describe the protocol for a randomised, controlled trial (RCT) designed to evaluate an intervention developed to increase physical activity as a treatment for depression within primary care.
The TREAD study is a pragmatic, multi-centre, two-arm RCT which targets patients presenting with a new episode of depression. Patients were approached if they were aged 18-69, had recently consulted their GP for depression and, where appropriate, had been taking antidepressants for less than one month. Only those patients with a confirmed diagnosis of a depressive episode as assessed by the Clinical Interview Schedule-Revised (CIS-R), a Beck Depression Inventory (BDI) score of at least 14 and informed written consent were included in the study. Eligible patients were individually randomised to one of two treatment groups; usual GP care or usual GP care plus facilitated physical activity. The primary outcome of the trial is clinical symptoms of depression assessed using the BDI four months after randomisation. A number of secondary outcomes are also measured at the 4-, 8- and 12-month follow-up points including quality of life, attitude to and involvement in physical activity and antidepressant use/adherence. Outcomes will be analysed on an intention-to-treat (ITT) basis and will use linear and logistic regression models to compare treatments.
The results of the trial will provide information about the effectiveness of physical activity as a treatment for depression. Given the current prevalence of depression and its associated economic burden, it is hoped that TREAD will provide a timely contribution to the evidence on treatment options for patients, clinicians and policy-makers.
Trial registration: ISRCTN 16900744
Objective To explore whether responses to questions in surveys of patients that purport to assess the performance of general practices or doctors reflect differences between practices, doctors, or the patients themselves.
Design Secondary analysis of data from a study of access to general practice, combining data from a survey of patients with information about practice organisation and doctors consulted, and using multilevel modelling at practice, doctor, and patient level.
Setting Nine primary care trusts in England.
Participants 4573 patients who consulted 150 different doctors in 27 practices.
Main outcome measures Overall satisfaction; experience of wait for an appointment; reported access to care; satisfaction with communication skills.
Results The experience based measure of wait for an appointment was more discriminating between practices (practice level accounted for 20.2% (95% confidence interval 9.1% to 31.3%) of variance) than was the overall satisfaction measure (practice level accounted for 4.6% (1.6% to 7.6%) of variance). Only 6.3% (3.8% to 8.9%) of the variance in the doctors’ communication skills measure was due to differences between doctors; 92.4% (88.5% to 96.4%) of the variance occurred at the level of the patient (including differences between patients’ perceptions and random variation). At least 79% of the variance on all measures occurred at the level of the patient, and patients’ age, sex, ethnicity, and housing and employment status explained some of this variation. However, adjustment for patients’ characteristics made very little difference to practices’ scores or the ranking of individual practices.
Conclusions Analyses of surveys of patients should take account of the hierarchical nature of the data by using multilevel models. Measures related to patients’ experience discriminate more effectively between practices than do measures of general satisfaction. Surveys of patients’ satisfaction fail to distinguish effectively between individual doctors because most of the variation in doctors’ reported performance is due to differences between patients and random error rather than differences between doctors. Although patients’ reports of satisfaction and experience are systematically related to patients’ characteristics such as age and sex, the effect of adjusting practices’ scores for the characteristics of their patients is small.
Recent changes in the organisation of primary health care have increased the range of professionals that patients may encounter, leading to renewed interest in the importance of continuity of care. To assess whether organisational changes have had an impact on continuity, it is necessary to define and measure the term. Researchers seeking to assess continuity face many conceptual and practical difficulties. This article argues that it is important to distinguish between three distinct but related concepts: longitudinal continuity from a minimum number of health professionals, caring relationships between patients and professionals, and well-coordinated care between professionals. An evaluation of Advanced Access as a case study is used to illustrate how researchers need to make several value judgements in operationalising longitudinal continuity. These include whether continuity should be measured from the perspective of patient, doctor, or healthcare system, the types of professionals and consultations that should be considered, the time period to be assessed, the measure to be used, and also practical considerations about data collection. It is argued that decisions about these issues should be based on an underlying hypothesis about why continuity may be important in the particular context. Distinguishing between longitudinal continuity, patient–professional relationships, and coordinated care makes it possible to examine interactions between these different concepts, and to examine relationships with outcomes such as patient satisfaction and quality of care. It will also give greater clarity to debates about whether new models of primary care reduce continuity.
continuity of patient care; family practice; outcome and process assessment (health care); primary health care
To determine the impact of establishing walk‐in centres alongside emergency departments (EDs) on attendance rates, visit duration, process, costs and outcome of care.
Eight hospitals with co‐located EDs and walk‐in centres were compared with eight matched EDs without walk‐in centres. Site visits were conducted. Routine data about attendance numbers and use of resources were analysed. A random sample of records of patients attending before and after the opening of walk‐in centres was also assessed. Patients who had not been admitted to hospital were sent a postal questionnaire.
At most sites, the walk‐in centres did not have a distinct identity and there were few differences in the way services were provided compared with control sites. Overall, there was no evidence of an increase in attendance at sites with walk‐in centres, but considerable variability across sites was found. The proportion of patients managed within the 4 h National Health Service target improved at sites both with and without walk‐in centres. There was no evidence of any difference in reconsultation rates, costs of care or patient outcomes at sites with or without walk‐in centres.
Most hospitals in this study implemented the walk‐in centre concept to a very limited extent. Consequently, there was no evidence of any effect on attendance rates, process, costs or outcome of care.
To explore the impact of establishing walk‐in centres alongside emergency departments on patient choice, preference and satisfaction.
A controlled, mixed‐method study comparing 8 emergency departments with co‐located walk‐in centres with the same number of “traditional” emergency departments. This paper focuses on the results of a cross‐sectional questionnaire survey of users.
Survey data demonstrated that patients were frequently unable to distinguish between being treated at a walk‐in centre or at an accident and emergency (A&E) department and, even where this was the case, opportunities to exercise choice about their preferred care provider were often limited. Few made an active choice to attend a co‐located walk‐in centre. Patients attending walk‐in centres were just as likely to be satisfied overall with the care they received as their counterparts who were treated in the co‐located A&E facility, although walk‐in centre users reported greater satisfaction with some specific aspects of their care and consultation.
Whereas one of the key policy goals underpinning the co‐location of walk‐in centres next to an A&E department was to provide patients with more options for accessing healthcare and greater choice, leading in turn to increased satisfaction, this evaluation was able to provide little evidence to support this. The high percentage of patients expressing a preference for care in an established emergency department compared with that in a new walk‐in centre facility raises questions for future policy development. Further consideration should therefore be given to the role that A&E‐focused walk‐in centres play in the Department of Health's current policy agenda, as far as patient choice is concerned.
Caesarean section is one of the most commonly performed major operations in women throughout the world. Rates are escalating, with studies from the United States of America, the United Kingdom, China and the Republic of Ireland reporting rates between 20% and 25%. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death.
The value of routine oxytocics in the third stage of vaginal birth has been well established and it has been assumed that these benefits apply to caesarean delivery as well. A slow bolus dose of oxytocin is recommended following delivery of the baby at caesarean section. Some clinicians use an additional infusion of oxytocin for a further period following the procedure. Intravenous oxytocin has a very short half-life (4–10 minutes) therefore the potential advantage of an oxytocin infusion is that it maintains uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhages occur. The few trials to date addressing the optimal approach to preventing haemorrhage at caesarean section have been under-powered to evaluate clinically important outcomes. There has been no trial to date comparing the use of an intravenous slow bolus of oxytocin versus an oxytocin bolus and infusion.
Methods and design
A multi-centre randomised controlled trial is proposed. The study will take place in five large maternity units in Ireland with collaboration between academics and clinicians in the disciplines of obstetrics and anaesthetics. It will involve 2000 women undergoing elective caesarean section after 36 weeks gestation. The main outcome measure will be major haemorrhage (blood loss >1000 ml). A study involving 2000 women will have 80% power to detect a 36% relative change in the risk of major haemorrhage with two-sided 5% alpha.
It is both important and timely that we evaluate the optimal approach to the management of the third stage at elective caesarean section. Safe operative delivery is now a priority and a reality for many pregnant women. Obstetricians, obstetric anaesthetists, midwives and pregnant women need high quality evidence on which to base management approaches. The overall aim is to reduce maternal haemorrhagic morbidity and its attendant risks at elective caesarean section.
Providing timely access to physiotherapy has long been a problem for the National Health Service in the United Kingdom. In an attempt to improve access some physiotherapy services have introduced a new treatment pathway known as PhysioDirect. Physiotherapists offer initial assessment and advice by telephone, supported by computerised algorithms, and patients are sent written self-management and exercise advice by post. They are invited for face-to-face treatment only when necessary. Although several such services have been developed, there is no robust evidence regarding clinical and cost-effectiveness, nor the acceptability of PhysioDirect.
This protocol describes a multi-centre pragmatic individually randomised trial, with nested qualitative research. The aim is to determine the effectiveness, cost-effectiveness, and acceptability of PhysioDirect compared with usual models of physiotherapy based on patients going onto a waiting list and receiving face-to-face care. PhysioDirect services will be established in four areas in England. Adult patients in these areas with musculoskeletal problems who refer themselves or are referred by a primary care practitioner for physiotherapy will be invited to participate in the trial. About 1875 consenting patients will be randomised in a 2:1 ratio to PhysioDirect or usual care. Data about outcome measures will be collected at baseline and 6 weeks and 6 months after randomisation. The primary outcome is clinical improvement at 6 months; secondary outcomes include cost, waiting times, time lost from work and usual activities, patient satisfaction and preference. The impact of PhysioDirect on patients in different age-groups and with different conditions will also be examined.
Incremental cost-effectiveness will be assessed in terms of quality adjusted life years in relation to cost.
Qualitative methods will be used to explore factors associated with the success or failure of the service, the acceptability of PhysioDirect to patients and staff, and ways in which the service could be improved.
It is still relatively unusual to evaluate new forms of service delivery using randomised controlled trials. By combining rigorous trial methods with economic analysis of cost-effectiveness and qualitative research this study will provide robust evidence to inform decisions about the widespread introduction of PhysioDirect services.
Current Controlled Trials ISRCTN55666618
A criticism of Randomized Controlled Trials (RCTs) in primary care is that they lack external validity, participants being unrepresentative of the wider population. Our aim was to determine whether published primary care-based RCTs report information about how the study sample is assembled, and whether this is associated with RCT characteristics.
We reviewed RCTs published in four primary care journals in the years 2001–2004. Main outcomes were: (1) eligibility fraction (proportion eligible of those screened), (2) enrolment fraction (proportion randomised of those eligible), (3) recruitment fraction (proportion of potential participants actually randomised), and (4) number of patients needed to be screened (NNS) in order to randomize one participant.
A total of 148 RCTs were reviewed. One hundred and three trials (70%) reported the number of individuals assessed by investigators for eligibility, 119 (80%) reported the number eligible for participation, and all reported the actual number recruited. The median eligibility fraction was 83% (IQR 40% to 100%), and the median enrolment fraction was 74% (IQR 49% to 92%). The median NNS was 2.43, with some trials reportedly recruiting every patient or practice screened for eligibility, and one trial screening 484 for each patient recruited. We found no association between NNS and journal, trial size, multi- or single-centre, funding source or type of intervention. There may be associations between provision of sufficient recruitment data for the calculation of NNS and funding source and type of intervention.
RCTs reporting recruitment data in primary care suggest that once screened for eligibility and found to match inclusion criteria patients are likely to be randomized. This finding needs to be treated with caution as it may represent inadequate identification or reporting of the eligible population. A substantial minority of RCTs did not provide sufficient information about the patient recruitment process.
Objective To estimate the cost to the NHS and to parents and carers of treating febrile preschool children with paracetamol, ibuprofen, or both, and to compare these costs with the benefits of each treatment regimen.
Design Cost consequences analysis and cost effectiveness analysis conducted as part of a three arm, randomised controlled trial.
Participants Children between the ages of 6 months and 6 years recruited from primary care and the community with axillary temperatures ≥37.8°C and ≤41°C.
Interventions Paracetamol, ibuprofen, or both drugs.
Main outcome measures Costs to the NHS and to parents and carers. Cost consequences analysis at 48 hours and 5 days comparing cost with children’s temperature, discomfort, activity, appetite, and sleep; cost effectiveness analysis at 48 hours comparing cost with percentage of children “recovered.”
Results Difficulties in recruiting children to the trial lowered the precision of the estimates of cost and some outcomes. At 48 hours, cost to the NHS was £11.33 for paracetamol, £8.49 for ibuprofen, and £8.16 for both drugs. By day 5 these costs rose to £19.63, £18.36, and £13.92 respectively. For parents and carers, the 48 hour costs were £23.86 for paracetamol, £20.60 for ibuprofen, and £25.07 for both, and the day 5 costs were £26.35, £29.90, and £24.02 respectively. Outcomes measured at 48 hours and 5 days were inconclusive because of lack of power; the cost effectiveness analysis at 48 hours provided little evidence that one treatment choice was significantly more cost effective than another. At 4 hours ibuprofen and the combined treatment were superior to paracetamol in terms of the trial primary outcome of time without fever; at 24 hours the combined treatment performed best on this outcome.
Conclusions There is no strong evidence of a difference in cost between the treatments, but clinical and cost data together indicate that using both drugs together may be most cost effective over the course of the illness. This treatment option performs best and is no more expensive because of less use of healthcare resources, resulting in lower costs to the NHS and to parents.
Objective To investigate whether paracetamol (acetaminophen) plus ibuprofen are superior to either drug alone for increasing time without fever and the relief of fever associated discomfort in febrile children managed at home.
Design Individually randomised, blinded, three arm trial.
Setting Primary care and households in England.
Participants Children aged between 6 months and 6 years with axillary temperatures of at least 37.8°C and up to 41.0°C.
Intervention Advice on physical measures to reduce temperature and the provision of, and advice to give, paracetamol plus ibuprofen, paracetamol alone, or ibuprofen alone.
Main outcome measures Primary outcomes were the time without fever (<37.2°C) in the first four hours after the first dose was given and the proportion of children reported as being normal on the discomfort scale at 48 hours. Secondary outcomes were time to first occurrence of normal temperature (fever clearance), time without fever over 24 hours, fever associated symptoms, and adverse effects.
Results On an intention to treat basis, paracetamol plus ibuprofen were superior to paracetamol for less time with fever in the first four hours (adjusted difference 55 minutes, 95% confidence interval 33 to 77; P<0.001) and may have been as good as ibuprofen (16 minutes, −7 to 39; P=0.2). For less time with fever over 24 hours, paracetamol plus ibuprofen were superior to paracetamol (4.4 hours, 2.4 to 6.3; P<0.001) and to ibuprofen (2.5 hours, 0.6 to 4.4; P=0.008). Combined therapy cleared fever 23 minutes (2 to 45; P=0.025) faster than paracetamol alone but no faster than ibuprofen alone (−3 minutes, 18 to −24; P=0.8). No benefit was found for discomfort or other symptoms, although power was low for these outcomes. Adverse effects did not differ between groups.
Conclusion Parents, nurses, pharmacists, and doctors wanting to use medicines to supplement physical measures to maximise the time that children spend without fever should use ibuprofen first and consider the relative benefits and risks of using paracetamol plus ibuprofen over 24 hours.
Trial registration Current Controlled Trials ISRCTN26362730.
General practices in England have been encouraged to introduce Advanced Access, but there is no robust evidence that this is associated with improved access in ways that matter to patients.
To compare priorities and experiences of patients consulting in practices which do or do not operate Advanced Access.
Design of study
Patient questionnaire survey.
Forty-seven practices in 12 primary care trust areas of England.
Questionnaire administered when patients consulted.
Of 12 825 eligible patients, 10 821 (84%) responded. Most (70%) were consulting about a problem they had had for at least ‘a few weeks’. Patients obtained their current appointment sooner in Advanced Access practices, but were less likely to have been able to book in advance. They could usually see a doctor more quickly than those in control practices, but were no more satisfied overall with the appointment system. The top priority for patients was to be seen on a day of choice rather than to be seen quickly, but different patient groups had different priorities. Patients in Advanced Access practices were no more or less likely to obtain an appointment that matched their priorities than those in control practices. Patients in both types of practice experienced problems making contact by telephone.
Patients are seen more quickly in Advanced Access practices, but speed of access is less important to patients than choice of appointment; this may be because most consultations are about long-standing problems. Appointment systems need to be flexible to accommodate the different needs of different patient groups.
appointment; family practice; health services accessibility; patient satisfaction; questionnaires
Case studies from the US suggest that Advanced Access appointment systems lead to shorter delays for appointments, reduced workload, and increased continuity of care.
To determine whether implementation of Advanced Access in general practice is associated with the above benefits in the UK.
Design of study
Controlled before-and-after and simulated-patient study.
Twenty-four practices that had implemented Advanced Access and 24 that had not.
Anonymous telephone calls were made monthly to request an appointment. Numbers of appointments and patients consulting were calculated from practice records. Continuity was determined from anonymised patient records.
The wait for an appointment with any doctor was slightly shorter at Advanced Access practices than control practices (mean 1.00 day and 1.87 days respectively, adjusted difference −0.75; 95% confidence interval [CI] = −1.51 to 0.004 days). Advanced Access practices met the NHS Plan 48-hour access target on 71% of occasions and control practices on 60% of occasions (adjusted odds ratio 1.61; 95% CI = 0.78 to 3.31; P = 0.200). The number of appointments offered, and patients seen, increased at both Advanced Access and control practices over the period studied, with no evidence of differences between them. There was no difference between Advanced Access and control practices in continuity of care (adjusted difference 0.003; 95% CI = −0.07 to 0.07).
Advanced Access practices provided slightly shorter waits for an appointment compared with control practices, but performance against NHS access targets was considerably poorer than officially reported for both types of practice. Advanced Access practices did not have reduced workload or increased continuity of care.
appointment systems; continuity of patient care; family practice; health services accessibility; workload
Few clinical rules have been derived let alone validated in primary care. A rule was derived to predict complications of acute cough in preschool children presenting to primary care. The clinical rule used the presence/absence of fever and/or chest signs to distinguish children at low, medium, and high risk of complications.
To validate a clinical rule for predicting complications of acute cough in preschool children in primary care.
Design of study
Prospective cohort study.
Thirteen general practices in Bristol and Tayside, UK.
Preschool children with cough up to 28 days and without asthma were recruited. The same sociodemographic, clinical history, examination, and complications data as for the derivation study were collected. First, univariable logistic regression was used to explore the associations with complications, and then predictors with stronger relationships (P<0.2) were modelled using multivariable logistic regression. These predictors were compared with derivation predictors with respect to their strength of association with complications. The derivation predictors were used in the validation dataset to allow comparison of the post-test probabilities of complications between derivation and validation studies.
The presence of fever and chest signs in the validation study tended to be protective for complications, with univariable odds ratios (ORs) of 0.37 and 0.81 respectively, compared with ORs of 4.86 and 2.72 in the derivation study. However, 95% confidence limits were wide and evidence for two other possible reasons for these results were found: spectrum bias and confounding by indication.
No evidence was found to validate the clinical rule for predicting complications of acute cough, possibly as a result of spectrum bias, confounding by indication, and/or chance. As paediatric infectious illness is costly and associated with high rates of antibiotic use, further research is needed to derive and validate prediction rules.
clinical prediction rule; complications; cough; primary care; prognosis; validation