C Jane Morrell

Costs and effectiveness of community postnatal support workers: randomised controlled trial.

Abstract Objectives: To establish the relative cost effectiveness of postnatal support in the community in addition to the usual care provided by community midwives. Design: Randomised controlled trial with six month follow up. Setting: Recruitment in a university teaching hospital and care provided in womens homes. Participants: 623 postnatal women allocated at random to intervention (311) or control (312) group. Intervention: Up to 10 home visits in the first postnatal month of up to three hours duration by a community postnatal support worker. Main outcome measure: General health status as measured by the SF-36 and risk of postnatal depression. Breast feeding rates, satisfaction with care, use of services, and personal costs. Results: At six weeks there was no significant improvement in health status among the women in the intervention group. At six weeks the mean total NHS costs were £635 for the intervention group and £456 for the control group (P=0.001). At six months figures were £815 and £639 (P=0.001). There were no differences between the groups in use of social services or personal costs. The women in the intervention group were very satisfied with the support worker visits. Conclusions: There was no health benefit of additional home visits by community postnatal support workers compared with traditional community midwifery visiting as measured by the SF-36. There were no savings to the NHS over six months after the introduction of the community postnatal support worker service.

Measuring health-related quality of life in patients with venous leg ulcers.

Introduction: The effect on quality of life by healing leg ulcers is not known and no validated disease-specific tool is available for measuring health-related quality of life (HRQoL) for people with venous leg ulcers. The objective of this paper was to compare four generic instruments [MOS 36-Item Short-Form Health Survey (SF-36); EuroQol (EQ); McGill Short Form Pain Questionnaire (SF-MPQ) and the Frenchay Activities Index (FAI)] used for measuring HRQoL in people with venous leg ulcers, and to offer guidance on the most appropriate tool for researchers. Methods: Two hundred and thirty-three patients with venous leg ulcers were recruited as part of a randomised controlled trial of the cost-effectiveness of community leg ulcer clinics. Subjects completed questionnaires containing the four instruments on three occasions (initial assessment, 3 and 12 months). The discriminative and evaluative properties of the four instruments were compared. Results: All four instruments were acceptable to patients, taking a mean of 19.3 (SD 6.3) min to complete. At initial assessment, the SF-MPQ had poorer discriminative properties than the other three instruments and was not able to distinguish between the different patient groups in relation to age and ulcer duration. The FAI was good at discriminating between the different patient groups (at initial assessment) in relation to age, mobility and ulcer size. At the three-month follow-up, the SF-MPQ was more responsive than the other measures and detected changes in HRQoL, whereas the EQ and SF-36 did not. At 12 months, the SF-MPQ still identified differences and the SF-36 and EQ also did at this stage. Conclusion: In the absence of a validated condition-specific tool for measuring changes in general health status for patients with venous leg ulcers, we make the following recommendations. For evaluating the outcome of interventions with a short-term follow-up (three months) in a clinical study we recommend the SF-MPQ and for 12-month follow-up in a clinical study the SF-36, with or without the SF-MPQ.

A systematic review, evidence synthesis and meta-analysis of quantitative and qualitative studies evaluating the clinical effectiveness, the cost-effectiveness, safety and acceptability of interventions to prevent postnatal depression.

BACKGROUND Postnatal depression (PND) is a major depressive disorder in the year following childbirth, which impacts on women, their infants and their families. A range of interventions has been developed to prevent PND. OBJECTIVES To (1) evaluate the clinical effectiveness, cost-effectiveness, acceptability and safety of antenatal and postnatal interventions for pregnant and postnatal women to prevent PND; (2) apply rigorous methods of systematic reviewing of quantitative and qualitative studies, evidence synthesis and decision-analytic modelling to evaluate the preventive impact on women, their infants and their families; and (3) estimate cost-effectiveness. DATA SOURCES We searched MEDLINE, EMBASE, Science Citation Index and other databases (from inception to July 2013) in December 2012, and we were updated by electronic alerts until July 2013. REVIEW METHODS Two reviewers independently screened titles and abstracts with consensus agreement. We undertook quality assessment. All universal, selective and indicated preventive interventions for pregnant women and women in the first 6 postnatal weeks were included. All outcomes were included, focusing on the Edinburgh Postnatal Depression Scale (EPDS), diagnostic instruments and infant outcomes. The quantitative evidence was synthesised using network meta-analyses (NMAs). A mathematical model was constructed to explore the cost-effectiveness of interventions contained within the NMA for EPDS values. RESULTS From 3072 records identified, 122 papers (86 trials) were included in the quantitative review. From 2152 records, 56 papers (44 studies) were included in the qualitative review. The results were inconclusive. The most beneficial interventions appeared to be midwifery redesigned postnatal care [as shown by the mean 12-month EPDS score difference of -1.43 (95% credible interval -4.00 to 1.36)], person-centred approach (PCA)-based and cognitive-behavioural therapy (CBT)-based intervention (universal), interpersonal psychotherapy (IPT)-based intervention and education on preparing for parenting (selective), promoting parent-infant interaction, peer support, IPT-based intervention and PCA-based and CBT-based intervention (indicated). Women valued seeing the same health worker, the involvement of partners and access to several visits from a midwife or health visitor trained in person-centred or cognitive-behavioural approaches. The most cost-effective interventions were estimated to be midwifery redesigned postnatal care (universal), PCA-based intervention (indicated) and IPT-based intervention in the sensitivity analysis (indicated), although there was considerable uncertainty. Expected value of partial perfect information (EVPPI) for efficacy data was in excess of £150M for each population. Given the EVPPI values, future trials assessing the relative efficacies of promising interventions appears to represent value for money. LIMITATIONS In the NMAs, some trials were omitted because they could not be connected to the main network of evidence or did not provide EPDS scores. This may have introduced reporting or selection bias. No adjustment was made for the lack of quality of some trials. Although we appraised a very large number of studies, much of the evidence was inconclusive. CONCLUSIONS Interventions warrant replication within randomised controlled trials (RCTs). Several interventions appear to be cost-effective relative to usual care, but this is subject to considerable uncertainty. FUTURE WORK RECOMMENDATIONS Several interventions appear to be cost-effective relative to usual care, but this is subject to considerable uncertainty. Future research conducting RCTs to establish which interventions are most clinically effective and cost-effective should be considered. STUDY REGISTRATION This study is registered as PROSPERO CRD42012003273. FUNDING The National Institute for Health Research Health Technology Assessment programme.

Measuring psychological health in the perinatal period: Workshop consensus statement, 19 March 2013

This consensus statement is the result of an invited workshop funded by the Society for Reproductive and Infant Psychology on Measuring Psychological Health in the Perinatal Period which was held in Oxford on the 19th March 2013. The details of those who participated in the workshop can be found at the end of the consensus statement. The workshop evolved out of recognition that a major limitation to research and practice in the perinatal period is identifying valid, reliable and clinically relevant measures of psychological health. Work Shop Aims: To explore the definition and measurement of key components of psychological health and related constructs, in maternity care research. To discuss design and reporting standards of measures in the perinatal period to support measurement development and appropriate use.

A psychometric systematic review of self-report instruments to identify anxiety in pregnancy.

Aims To report a systematic review of the psychometric properties of self-report instruments to identify the symptoms of anxiety in pregnancy to help clinicians and researchers select the most suitable instrument. Background Excessive anxiety in pregnancy is associated with adverse birth outcomes, developmental and behavioural problems in infants and postnatal depression. Despite recommendations for routine psychological assessment in pregnancy, the optimal methods to identify anxiety in pregnancy have not been confirmed. Design Psychometric systematic review. Data sources A systematic literature search of the multiple databases (1990–September 2014). Review methods Identification of self-report instruments to measure anxiety in pregnancy using COSMIN guidelines to assess studies reporting a psychometric evaluation of validity and reliability. Results Thirty-two studies were included. Studies took place in the UK, Australia, Belgium, Canada, Germany, Italy, Scandinavia, Spain and the Netherlands. Seventeen different instruments were identified. Measures of validity were reported in 19 papers and reliability in 16. The overall quality of the papers was rated as fair to excellent using the COSMIN checklist. Only one paper scored excellent in more than one category. Conclusion Many instruments have been adapted for use in different populations to those for which they were designed. The State Trait Anxiety Inventory, Edinburgh Postnatal Depression Scale and the Hospital Anxiety and Depression Scale have been tested more frequently than other instruments, yet require further assessment to confirm their value for use in pregnancy.AIMS To report a systematic review of the psychometric properties of self-report instruments to identify the symptoms of anxiety in pregnancy to help clinicians and researchers select the most suitable instrument. BACKGROUND Excessive anxiety in pregnancy is associated with adverse birth outcomes, developmental and behavioural problems in infants and postnatal depression. Despite recommendations for routine psychological assessment in pregnancy, the optimal methods to identify anxiety in pregnancy have not been confirmed. DESIGN Psychometric systematic review. DATA SOURCES A systematic literature search of the multiple databases (1990-September 2014). REVIEW METHODS Identification of self-report instruments to measure anxiety in pregnancy using COSMIN guidelines to assess studies reporting a psychometric evaluation of validity and reliability. RESULTS Thirty-two studies were included. Studies took place in the UK, Australia, Belgium, Canada, Germany, Italy, Scandinavia, Spain and the Netherlands. Seventeen different instruments were identified. Measures of validity were reported in 19 papers and reliability in 16. The overall quality of the papers was rated as fair to excellent using the COSMIN checklist. Only one paper scored excellent in more than one category. CONCLUSION Many instruments have been adapted for use in different populations to those for which they were designed. The State Trait Anxiety Inventory, Edinburgh Postnatal Depression Scale and the Hospital Anxiety and Depression Scale have been tested more frequently than other instruments, yet require further assessment to confirm their value for use in pregnancy.

Training health visitors in cognitive behavioural and person-centred approaches for depression in postnatal women as part of a cluster randomised trial and economic evaluation in primary care: the PoNDER trial

AIM This paper aims to describe the training preparation for health visitors who took part in the intervention arm of a cluster randomised controlled trial and economic evaluation of training for health visitors - the POstNatal Depression Economic evaluation and Randomised (the PoNDER) trial. A secondary aim is to make available, by electronic links, the training manuals developed for and used for the cognitive behavioural approach (CBA) and the person-centred approach (PCA) training for the health visitors. The paper is of relevance to health visitors, general practitioners, nurse practitioners, midwives, clinical psychologists, mental health nurses, community psychiatric nurses, counsellors, and service commissioners. BACKGROUND The trial clinical outcomes have been published, indicating the pragmatic effectiveness of the package of training for health visitors to identify depressive symptoms and provide a psychologically informed intervention. The training was associated with a reduction in depressive symptoms at six months postnatally among intervention group women and some evidence of a benefit for the intervention group for some of the secondary outcomes at 18 months follow-up. METHODS The two experimental interventions examined in the PoNDER trial built upon promising work on the potential for psychological interventions to help women recover from postnatal depression as an alternative to pharmaceutical interventions and to address the limitations of previous research in the area. FINDINGS The package of health visitor training comprised the development of clinical skills in assessing postnatal women and identifying depressive symptoms, and the delivery of a CBA or a PCA for eligible women. This was the largest trial a health visitor intervention and of postnatal depression ever conducted. We are aware of no other rigorously performed trial that has published details of an extensively tested training programme for the benefit of health-care professionals and clients.

Coming in from the cold? An analysis of research proposals submitted by the Nursing Section at ScHARRI, 1994-1997

The Nursing Section at SCHARR was established in 1994 as one of six groups that constituted the Sheffield Centre for Health and Related Research (SCHARR). Based at the University of Sheffield, SCHARR was established as a response to the imperatives outlined in NHS Research and Development Strategy documentation for multidisciplinary health services research (HSR). The Nursing Section at SCHARR has always been fully supportive of such principles and over the past three years has worked with many different health-care researchers to maximise the nursing contribution to health services research. This paper analyses the features of 50 proposals made by the Nursing Section to funding bodies since 1994. Approximately half (52%, n=26) of all bids were successful and led to a total of nurse-related research grants worth 2.7 million pounds. Projects were significantly more likely to be funded if the method proposed was qualitative (or a combination of methods) or the lead researcher was a nurse. However, research was no more likely to be funded if a medical colleague was named as a collaborator, a statistician or health economist was involved in the bid, there were more than three named collaborators on the proposal, or the bid came from more than one university. The implications of these results are discussed in the context of recent critical commentaries on the topic of nursessupposed relative disadvantage in obtaining funds for multidisciplinary health services research.

Identification of depressive disorder among older people in care homes - a feasibility study.

BACKGROUND Depression is common among older people but more common among those living in care homes. Depression is not easily detected among older adults because of the presentation, and the tendency for older people not to complain of depression, particularly those living in care homes. In general, care home staff have limited training in recognising depression. Depression is undertreated and residents may not receive a therapeutic dose of antidepressant. The true prevalence of depression among care home residents is uncertain. METHOD This feasibility study aimed to explore the level of depression among older people in care homes by comparing the outcome of an assessment by care home staff with the outcome of a diagnostic clinical interview, using ICD-10 criteria and the 30-item Geriatric Depression Scale (GDS), conducted by a psychiatrist. RESULTS In all, 47 older people from four care homes were interviewed by a psychiatrist. Of them, 39.1% (18/46) of residents were prescribed an antidepressant and were no longer depressed; 8.7% (4/46) were prescribed an antidepressant and remained depressed; and 6.5% (3/46) of residents assessed as being depressed, had not been prescribed an antidepressant. That is, 54% (25/46) of residents had been or were currently depressed. Using ICD-10 criteria, the sensitivity of the GDS at a threshold of 10 and 11 was 100%. In total, 89.4% of residents received a correct diagnosis (presence or absence of depression) using the GDS at the 11 threshold. SUMMARY The prevalence of depression in these homes was 54%. Of the residents with depression, 72% (18/25) were managed with an antidepressant and 28% (7/25) were receiving ineffective or no treatment. The 30-item GDS can provide more useful information than a home care staff assessment for identifying depression. More research should explore the value of training home care staff to administer the 30-item GDS to optimise the management of depression in older people in care homes.

Analysing data from a cluster randomized trial (cRCT) in primary care: a case study

Health technology assessment often requires the evaluation of interventions which are implemented at the level of the health service organization unit (e.g. GP practice) for clusters of individuals. In a cluster randomized controlled trial (cRCT), clusters of patients are randomized; not each patient individually. The majority of statistical analyses, in individually RCT, assume that the outcomes on different patients are independent. In cRCTs there is doubt about the validity of this assumption as the outcomes of patients, in the same cluster, may be correlated. Hence, the analysis of data from cRCTs presents a number of difficulties. The aim of this paper is to describe the statistical methods of adjusting for clustering, in the context of cRCTs. There are essentially four approaches to analysing cRCTs: 1. Cluster-level analysis using aggregate summary data. 2. Regression analysis with robust standard errors. 3. Random-effects/cluster-specific approach. 4. Marginal/population-averaged approach. This paper will compare and contrast the four approaches, using example data, with binary and continuous outcomes, from a cRCT designed to evaluate the effectiveness of training Health Visitors in psychological approaches to identify post-natal depressive symptoms and support post-natal women compared with usual care. The PoNDER Trial randomized 101 clusters (GP practices) and collected data on 2659 new mothers with an 18-month follow-up.

Women’s views on anxiety in pregnancy and the use of anxiety instruments: a qualitative study

Abstract Objective: To explore women’s experience of anxiety in pregnancy and views on the use of anxiety instruments in antenatal care. Background: Anxiety in pregnancy is associated with adverse birth outcomes, developmental and behavioural problems in infants and postnatal depression. Despite recommendations for routine psychological assessment in pregnancy, the optimal methods to identify anxiety in pregnancy have not been confirmed. Methods: A qualitative study using two focus group discussions was undertaken. Focus group one included women in a community setting and focus group two included women in a hospital clinic setting who had received additional support for anxiety in pregnancy. Participants were women who had given birth within the past nine months and considered themselves to have been anxious during their pregnancy. Results: Three main themes were identified using template analysis: sources of support, administration of anxiety instruments and the use of instruments to prompt discussion. Women stated that anxiety instruments could help them to identify their anxious feelings and prompt a discussion around those feelings. However, they expressed concerns surrounding the administration of anxiety instruments and questioned how useful they would be in helping women access help and support. Conclusions: The introduction of anxiety instruments in antenatal care may present an opportunity to discuss women’s emotional health and anxieties. Providing women with sufficient time to discuss their anxious feelings, identified by such instruments, could facilitate access to additional support.