Can community midwives prevent antenatal depression? An external pilot study to test the feasibility of a cluster randomized controlled universal prevention trial.

BACKGROUND: Repeated epidemiological surveys show no decline in depression although uptake of treatments has grown. Universal depression prevention interventions are effective in schools but untested rigorously in adulthood. Selective prevention programmes have poor uptake. Universal interventions may be more acceptable during routine healthcare contacts for example antenatally. One study within routine postnatal healthcare suggested risk of postnatal depression could be reduced in non-depressed women from 11% to 8% by giving health visitors psychological intervention training. Feasibility and effectiveness in other settings, most notably antenatally, is unknown. METHOD: We conducted an external pilot study using a cluster trial design consisting of recruitment and enhanced psychological training of randomly selected clusters of community midwives (CMWs), recruitment of pregnant women of all levels of risk of depression, collection of baseline and outcome data prior to childbirth, allowing time for women 'at increased risk' to complete CMW-provided psychological support sessions. RESULTS: Seventy-nine percent of eligible women approached agreed to take part. Two hundred and ninety-eight women in eight clusters participated and 186 termed 'at low risk' for depression, based on an Edinburgh Perinatal Depression Scale (EPDS) score of <12 at 12 weeks gestation, provided baseline and outcome data at 34 weeks gestation. All trial protocol procedures were shown to be feasible. Antenatal effect sizes in women 'at low risk' were similar to those previously demonstrated postnatally. Qualitative work confirmed the acceptability of the approach to CMWs and intervention group women. CONCLUSION: A fully powered trial testing universal prevention of depression in pregnancy is feasible, acceptable and worth undertaking.

Universal prevention of depression in women postnatally: cluster randomized trial evidence in primary care.

BACKGROUND: To test whether receiving care from a health visitor (HV) trained in identification and psychological intervention methods prevents depression 6-18 months postnatally in women who are not depressed 6 weeks postnatally. METHOD: The study was a prospective cluster trial, randomized by GP practice, with follow-up for 18 months in 101 primary care teams in the Trent area of England. The participants were women scoring <12 on the postal Edinburgh Postnatal Depression Scale (EPDS) at 6 weeks postnatally (1474 intervention and 767 control women). Intervention HVs (n=89, 63 clusters) were trained in identifying depressive symptoms using the EPDS and face-to-face clinical assessment and in providing psychologically orientated sessions based on cognitive behavioral or person-centered principles. The control group comprised HVs (n=49, 37 clusters) providing care as usual (CAU). The primary outcome measure was the proportion of women scoring ≥ 12 on the EPDS at 6 months postnatally. Secondary outcomes were mean EPDS score, Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) score, State-Trait Anxiety Inventory (STAI), 12-item Short Form Health Survey (SF-12) and Parenting Stress Index Short Form (PSI-SF) scores at 6, 12 and 18 months. RESULTS: After adjusting for individual-level covariates, living alone, previous postnatal depression (PND), the presence of one or more adverse life events and the 6-week EPDS score, the odds ratio (OR) for EPDS ≥ 12 at 6 months was 0.71 [95% confidence interval (CI) 0.53-0.97, p=0.031] for the intervention group (IG) women compared with the control (CAU) group women. Two subgroups were formed by baseline severity: a 'subthreshold' subgroup with a 6-week EPDS score of 6-11 (n=999) and a 'lowest severity' subgroup with a 6-week EPDS score of 0-5 (n=1242). There was no difference in psychological effectiveness by subgroup (interaction term: z=-0.28, p=0.782). CONCLUSIONS: This study provides new evidence of a universal, enduring preventive effect for depression in women who screen negative for depression postnatally.

The development of two postnatal health instruments: one for mothers (M-PHI) and one for fathers (F-PHI) to measure health during the first year of parenting.

PURPOSE: To develop and psychometrically evaluate two questionnaires measuring both positive and negative postnatal health of mothers (M-PHI) and fathers (F-PHI) during the first year of parenting. METHODS: The M-PHI and the F-PHI were developed in four stages. Stage 1: Postnatal women's focus group (M-PHI) and postnatal fathers' postal questionnaire (F-PHI); Stage 2: Qualitative interviews; Stage 3: Pilot postal survey and main postal survey; and Stage 4: Test-retest postal survey. RESULTS: The M-PHI consisted of a 29-item core questionnaire with six main scales and five conditional scales. The F-PHI consisted of a 27-item questionnaire with six main scales. All scales achieved good internal reliability (Cronbach's α 0.66-0.87 for M-PHI, 0.72-0.90 for F-PHI). Intraclass correlation coefficients demonstrated high test-retest reliability (0.60-0.88). Correlation coefficients supported the criterion validity of the M-PHI and the F-PHI when tested against the Short-Form-12 (SF-12), Edinburgh Postnatal Depression Scale (EPDS) and the Warwick and Edinburgh Mental Well-Being Scale (WEMWBS). CONCLUSION: The M-PHI and F-PHI are valid, reliable, parent-generated instruments. These unique instruments will be invaluable for practitioners wishing to promote family-centred care and for trialists and other researchers requiring a validated instrument to measure both positive and negative health during the first postnatal year, as to date no such measurement has existed.

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

OBJECTIVES: This study aimed to measure the effect and the total cost per woman of providing postnatal support at home, based on a Dutch model. The research hypothesis was furnished by some existing evidence that postnatal support could reduce the risk of postnatal depression and encourage breastfeeding. DESIGN: The randomised controlled trial aimed to measure differences in health status in a group of women who were offered postnatal support from a community midwifery support worker (SW) compared with a control group of women who were not offered this support. Women were followed-up by postal questionnaire at 6 weeks and 6 months postnatally. SETTING AND SUBJECTS: All women who delivered a baby at the recruiting hospital were eligible to take part in the trial if they lived within the study area, were aged 17 years or over, and could understand English. INTERVENTION: The intervention consisted of the SW offering practical and emotional support and to help women rest and recover after childbirth. The SW offered ten visits in the first 28 days postnatally, for up to 3 hours per day. The SW's activities included housework, talking with the mother, and care for the baby or other siblings. The service was provided in addition to routine visits by the community midwife. MAIN OUTCOME MEASURES: The primary outcome was the general health perception domain of the Short Form-36 at 6 weeks. Secondary outcomes were mean Edinburgh Postnatal Depression Scale (EPDS), Duke Functional Social Support (DUFSS) scores and breastfeeding rates. RESULTS: The 623 randomised women were well-matched by group with a good response to follow-up. At 6 weeks there was no evidence of a significant difference between the two groups for the primary outcome. There was a non-significant trend for the control group to have better mean DUFSS and EPDS scores at 6 weeks. Breastfeeding rates were not significantly different at follow-up. At 6 months, both groups had similar health status. Satisfaction with the service was higher than for all other services received. The incremental cost of introducing the service comprised setting up and running the service. There were no differences between the groups in other resource use (general practitioner contacts, hospital services, prescriptions or medicines bought for mothers and babies) to 6-month follow-up. The total mean NHS cost to 6-month follow-up for the intervention group was pound180 per woman greater than for the control group (confidence interval, pound79.60, pound272.40). CONCLUSIONS: Although women valued the service, there was no evidence of any health benefit at the 6-week or 6-month follow-up, no difference in use of NHS services, and the additional cost of the service provision would be around pound 180 per woman.

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

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 women's 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 pound 635 for the intervention group and pound 456 for the control group (P=0.001). At six months figures were pound 815 and pound 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.

Cost effectiveness of community leg ulcer clinics: randomised controlled trial.

OBJECTIVES: To establish the relative cost effectiveness of community leg ulcer clinics that use four layer compression bandaging versus usual care provided by district nurses. DESIGN: Randomised controlled trial with 1 year of follow up. SETTING: Eight community based research clinics in four trusts in Trent. SUBJECTS: 233 patients with venous leg ulcers allocated at random to intervention (120) or control (113) group. INTERVENTIONS: Weekly treatment with four layer bandaging in a leg ulcer clinic (clinic group) or usual care at home by the district nursing service (control group). MAIN OUTCOME MEASURES: Time to complete ulcer healing, patient health status, and recurrence of ulcers. Satisfaction with care, use of services, and personal costs were also monitored. RESULTS: The ulcers of patients in the clinic group tended to heal sooner than those in the control group over the whole 12 month follow up (log rank P=0.03). At 12 weeks, 34% of patients in the clinic group were healed compared with 24% in the control. The crude initial healing rate of ulcers in intervention compared with control patients was 1.45 (95% confidence interval 1.04 to 2. 03). No significant differences were found between the groups in health status. Mean total NHS costs were 878.06 pounds per year for the clinic group and 859.34 pounds for the control (P=0.89). CONCLUSIONS: Community based leg ulcer clinics with trained nurses using four layer bandaging is more effective than traditional home based treatment. This benefit is achieved at a small additional cost and could be delivered at reduced cost if certain service configurations were used.

Community-based leg ulcer clinics: organisation and cost-effectiveness.

To establish the cost effectiveness of community leg ulcer clinics using four-layer compression bandaging and the care provided by district nurses, a randomised controlled trial was set up in eight community-based research clinics in four trusts, funded by Trent Regional Health Authority. The main outcomes monitored were the amount of time needed to complete ulcer healing, patient health status, and recurrence. Satisfaction with care, use of services and personal costs were also monitored.

Psychological interventions for postnatal depression: cluster randomised trial and economic evaluation. The PoNDER trial.

OBJECTIVES: To investigate outcomes for postnatal women attributed to special training for health visitors (HVs) in systematically identifying postnatal depression and delivering psychologically informed interventions, and to establish the cost-effectiveness of the intervention. DESIGN: A pragmatic randomised cluster trial with clusters allocated to experimental HV training arms or control, with an 18-month follow-up. SETTING: GP practices in the former Trent Regional Health Authority. PARTICIPANTS: Women registered with participating GP practices who became 36 weeks pregnant during the recruitment phase of the trial, had a live baby and were on a collaborating HV's caseload for 4 months postnatally. INTERVENTION: HV training in the assessment of postnatal women, combined with either cognitive behavioural approach (CBA) or person-centred approach (PCA) sessions for eligible women, plus the option of a selective serotonin reuptake inhibitor if indicated. MAIN OUTCOME MEASURES: The primary outcome was the proportion of at-risk women with a 6-month Edinburgh Postnatal Depression Scale (EPDS) score > or = 12. The primary comparison was between at-risk women in the combined clusters randomised to HV training and women in practices randomised to provide HV usual care. The secondary comparison was to determine any differences between the proportions of women with a 6-month EPDS score > or = 12 in the CBA and PCA groups. RESULTS: HVs in 101 clusters in 29 primary care trusts collaborated in the study. From 7649 eligible women 4084 (53.4%) consented to take part: 17.3% (595/3449) of women who returned a 6-week questionnaire had a 6-week EPDS score > or = 12 and were at-risk women; 70.3% (418/595) of at-risk women had a 6-month EPDS score available. In total, 45.6% (67/147) of control group (CG) at-risk women had a 6-month EPDS score > or = 12 versus 33.9% (93/271) of intervention group (IG) women (p = 0.036). A total of 32.9% (46/140) of at-risk women in the CBA group versus 35.1% (46/131) in the PCA group had a 6-month EPDS score > or = 12 (p = 0.74). The CG mean 6-month EPDS score for at-risk women was 11.3 (SD 5.8) versus 9.2 (SD 5.4) for the IG (p = 0.002) and this remained statistically significant after adjusting for 6-week variables (p = 0.001). In total, 16.4% (150/914) of all women in the CG had a 6-month EPDS score > or = 12 compared with 11.7% (205/1745) in the IG (p = 0.003). The CG mean 6-month EPDS score for all women was 6.4 (SD 5.2) compared with 5.5 (SD 4.7) for the IG (p < 0.001). The economic analysis results showed a consistent pattern of psychological approaches being cost-effective at funding levels used by the National Institute for Health and Clinical Excellence. CONCLUSIONS: HV training was effective compared with HV usual care in reducing the proportion of at-risk women with a 6-month EPDS score > or = 12, with a wide confidence interval for the estimated intervention effect, suggesting that the true treatment effect may be small. The effect remained for 1 year. The economic evaluation demonstrated that the HV intervention was highly likely to be cost-effective compared with the control. There was no difference in outcomes between the CBA and the PCA groups.

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.

Impact of NHS Direct on other services: the characteristics and origins of its nurses.

OBJECTIVE: To characterise the NHS Direct nurse workforce and estimate the impact of NHS Direct on the staffing of other NHS nursing specialties. METHOD: A postal survey of NHS Direct nurses in all 17 NHS Direct call centres operating in June 2000. RESULTS: The response rate was 74% (682 of 920). In the three months immediately before joining NHS Direct, 20% (134 of 682, 95% confidence intervals 17% to 23%) of respondents had not been working in the NHS. Of the 540 who came from NHS nursing posts, one fifth had come from an accident and emergency department or minor injury unit (110 of 540), and one in seven from practice nursing (75 of 540). One in ten (65 of 681) nurses said that previous illness, injury, or disability had been an important reason for deciding to join NHS Direct. Sixty two per cent (404 of 649) of nurses felt their job satisfaction and work environment had improved since joining NHS Direct. CONCLUSION: The NHS Direct nurse workforce currently constitutes a small proportion (about 0.5%) of all qualified nurses in the NHS, although it recruits relatively experienced and well qualified nurses more heavily from some specialties, such as accident and emergency nursing, than others. However, its overall impact on staffing in any one specialty is likely to be small. NHS Direct has succeeded in providing employment for some nurses who might otherwise be unable to continue in nursing because of disability.