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Background: The NHS is the biggest employer in the UK. Depression and anxiety are common reasons for sickness absence among staff. Evidence suggests that an intervention based on a case management model using a biopsychosocial approach could be cost-effective and lead to earlier return to work for staff with common mental health disorders., Objective: The objective was to assess the feasibility and acceptability of conducting a trial of the clinical effectiveness and cost-effectiveness of an early occupational health referral and case management intervention to facilitate the return to work of NHS staff on sick leave with any common mental health disorder (e.g. depression or anxiety)., Design: A multicentre mixed-methods feasibility study with embedded process evaluation and economic analyses. The study comprised an updated systematic review, survey of care as usual, and development of an intervention in consultation with key stakeholders. Although this was not a randomised controlled trial, the study design comprised two arms where participants received either the intervention or care as usual., Participants: Participants were NHS staff on sick leave for 7 or more consecutive days but less than 90 consecutive days, with a common mental health disorder., Intervention: The intervention involved early referral to occupational health combined with standardised work-focused case management., Control/comparator: Participants in the control arm received care as usual., Primary Outcome: The primary outcome was the feasibility and acceptability of the intervention, study processes (including methods of recruiting participants) and data collection tools to measure return to work, episodes of sickness absence, workability (a worker's functional ability to perform their job), occupational functioning, symptomatology and cost-effectiveness proposed for use in a main trial., Results: Forty articles and two guidelines were included in an updated systematic review. A total of 49 of the 126 (39%) occupational health providers who were approached participated in a national survey of care as usual. Selected multidisciplinary stakeholders contributed to the development of the work-focused case management intervention (including a training workshop). Six NHS trusts (occupational health departments) agreed to take part in the study, although one trust withdrew prior to participant recruitment, citing staff shortages. At mixed intervention sites, participants were sequentially allocated to each arm, where possible. Approximately 1938 (3.9%) NHS staff from the participating sites were on sick leave with a common mental health disorder during the study period. Forty-two sick-listed NHS staff were screened for eligibility on receipt of occupational health management referrals. Twenty-four (57%) participants were consented: 11 (46%) received the case management intervention and 13 (54%) received care as usual. Follow-up data were collected from 11 out of 24 (46%) participants at 3 months and 10 out of 24 (42%) participants at 6 months. The case management intervention and case manager training were found to be acceptable and inexpensive to deliver. Possible contamination issues are likely in a future trial if participants are individually randomised at mixed intervention sites., Harms: No adverse events were reported., Limitations: The method of identification and recruitment of eligible sick-listed staff was ineffective in practice because uptake of referral to occupational health was low, but a new targeted method has been devised., Conclusion: All study questions were addressed. Difficulties raising organisational awareness of the study coupled with a lack of change in occupational health referral practices by line managers affected the identification and recruitment of participants. Strategies to overcome these barriers in a main trial were identified. The case management intervention was fit for purpose and acceptable to deliver in the NHS., Trial Registration: Current Controlled Trials ISRCTN14621901., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 25, No. 12. See the NIHR Journals Library website for further project information.

Background: Chronic pain is a common cause of health-related incapacity for work among people in the UK. Individualised placement and support is a systematic approach to rehabilitation, with emphasis on early supported work placement. It is effective in helping people with severe mental illness to gain employment, but has not been tested for chronic pain., Objective: To inform the design of a definitive randomised controlled trial to assess the clinical effectiveness of individualised placement and support for people unemployed because of chronic pain., Methods: A mixed-methods feasibility study comprising qualitative interviews and focus groups with key stakeholders, alongside a pilot trial., Study Participants: Primary care-based health-care professionals, employment support workers, employers, clients who participated in an individualised placement and support programme, and individuals aged 18-64 years with chronic pain who were unemployed for at least 3 months., Intervention: An individualised placement and support programme integrated with a personalised, responsive pain management plan, backed up by communication with a general practitioner and rapid access to community-based pain services., Outcomes: Outcomes included stakeholder views about a trial and methods of recruitment; the feasibility and acceptability of the individualised placement and support intervention; study processes (including methods to recruit participants from primary care, training and support needs of the employment support workers to integrate with pain services, acceptability of randomisation and the treatment-as-usual comparator); and scoping of outcome measures for a definitive trial., Results: All stakeholders viewed a trial as feasible and important, and saw the relevance of employment interventions in this group. Using all suggested methods, recruitment was feasible through primary care, but it was slow and resource intensive. Recruitment through pain services was more efficient. Fifty people with chronic pain were recruited (37 from primary care and 13 from pain services). Randomisation was acceptable, and 22 participants were allocated to individualised placement and support, and 28 participants were allocated to treatment as usual. Treatment as usual was found acceptable. Retention of treatment-as-usual participants was acceptable throughout the 12 months. However, follow-up of individualised placement and support recipients using postal questionnaires proved challenging, especially when the participant started paid work, and new approaches would be needed for a trial. Clients, employment support workers, primary care-based health-care professionals and employers contributed to manualisation of the intervention. No adverse events were reported., Conclusion: Unless accurate and up-to-date employment status information can be collected in primary care health records, or linkage can be established with employment records, research such as this relating to employment will be impracticable in primary care. The trial may be possible through pain services; however, clients may differ. Retention of participants proved challenging and methods for achieving this would need to be developed. The intervention has been manualised., Trial Registration: Current Controlled Trials ISRCTN30094062., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 25, No. 5. See the NIHR Journals Library website for further project information.

Background: Although strategies have been developed to minimise the risk of occupational hand dermatitis in nurses, their clinical effectiveness and cost-effectiveness remain unclear., Objectives: The Skin Care Intervention in Nurses trial tested the hypothesis that a behaviour change package intervention, coupled with provision of hand moisturisers, could reduce the point prevalence of hand dermatitis when compared with standard care among nurses working in the NHS. The secondary aim was to assess the impact of the intervention on participants' beliefs and behaviour regarding hand care, and the cost-effectiveness of the intervention in comparison with normal care., Design: Cluster randomised controlled trial., Setting: Thirty-five NHS hospital trusts/health boards/universities., Participants: First-year student nurses with a history of atopic tendency, and full-time intensive care unit nurses., Intervention: Sites were randomly allocated to be 'intervention plus' or 'intervention light'. Participants at 'intervention plus' sites received access to a bespoke online behaviour change package intervention, coupled with personal supplies of moisturising cream (student nurses) and optimal availability of moisturising cream (intensive care unit nurses). Nurses at 'intervention light' sites received usual care, including a dermatitis prevention leaflet., Main Outcome Measure: The difference between intervention plus and intervention light sites in the change of point prevalence of visible hand dermatitis was measured from images taken at baseline and at follow-up., Randomisation: Fourteen sites were randomised to the intervention plus arm, and 21 sites were randomised to the intervention light arm., Blinding: The participants, trial statistician, methodologist and the dermatologists interpreting the hand photographs were blinded to intervention assignment., Numbers Analysed: An intention-to-treat analysis was conducted on data from 845 student nurses and 1111 intensive care unit nurses., Results: The intention-to-treat analysis showed no evidence that the risk of developing dermatitis was greater in the intervention light group than in the intervention plus group (student nurses: odds ratio 1.25, 95% confidence interval 0.59 to 2.69; intensive care unit nurses: odds ratio 1.41, 95% confidence interval 0.81 to 2.44). Both groups had high levels of baseline beliefs about the benefits of using hand moisturisers before, during and after work. The frequency of use of hand moisturisers before, during and after shifts was significantly higher in the intensive care unit nurses in the intervention plus arm at follow-up than in the comparator group nurses. For student nurses, the intervention plus group mean costs were £2 lower than those for the comparator and 0.00002 more quality-adjusted life-years were gained. For intensive care unit nurses, costs were £4 higher and 0.0016 fewer quality-adjusted life-years were gained., Harms: No adverse events were reported., Limitations: Only 44.5% of participants in the intervention plus arm accessed the behaviour change package., Conclusion: The intervention did not result in a statistically significant decrease in the prevalence of hand dermatitis in the intervention plus group., Future Work: Participants had a high level of baseline beliefs about the importance of using hand moisturisers before, during and after work. Future research should focus on how workplace culture can be changed in order for that knowledge to be actioned., Trial Registration: Current Controlled Trials ISRCTN53303171., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 58. See the NIHR Journals Library website for further project information., Competing Interests: Ira Madan reports being the chairperson of the National Institute for Health Research (NIHR)’s Health Technology Assessment (HTA) Mental Health panel from 1 January 2018 to December 2020. Vaughan Parsons reports personal fees from the magazine Occupational Health at Work during the conduct of the trial. Alison Wright reports other grants from the NIHR HTA programme during the conduct of the study. Julia Smedley reports other grants from NIHR via Guy’s and St Thomas’ NHS Foundation Trust (lead centre) during the conduct of the study (HTA reference number 15/107/02). Hywel Williams is Director of the HTA programme and chairperson of the HTA Commissioning Board. From 1 January 2016, he became Programme Director for the HTA programme.

Background: It is unclear whether or not the current evidence base allows definite conclusions to be made regarding the optimal maternal circulating concentration of 25-hydroxyvitamin D [25(OH)D] during pregnancy, and how this might best be achieved., Objectives: To answer the following questions: (1) What are the clinical criteria for vitamin D deficiency in pregnant women? (2) What adverse maternal and neonatal health outcomes are associated with low maternal circulating 25(OH)D? (3) Does maternal supplementation with vitamin D in pregnancy lead to an improvement in these outcomes (including assessment of compliance and effectiveness)? (4) What is the optimal type (D2 or D3), dose, regimen and route for vitamin D supplementation in pregnancy? (5) Is supplementation with vitamin D in pregnancy likely to be cost-effective?, Methods: We performed a systematic review and where possible combined study results using meta-analysis to estimate the combined effect size. Major electronic databases [including Database of Abstracts of Reviews of Effects (DARE), Centre for Reviews and Dissemination (CRD), Cochrane Database of Systematic Reviews (CDSR) and the Health Technology Assessment (HTA) database] were searched from inception up to June 2012 covering both published and grey literature. Bibliographies of selected papers were hand-searched for additional references. Relevant authors were contacted for any unpublished findings and additional data if necessary. Abstracts were reviewed by two reviewers., Subjects: pregnant women or pregnant women and their offspring., Exposure: either assessment of vitamin D status [dietary intake, sunlight exposure, circulating 25(OH)D concentration] or supplementation of participants with vitamin D or food containing vitamin D (e.g. oily fish)., Outcomes: offspring - birthweight, birth length, head circumference, bone mass, anthropometry and body composition, risk of asthma and atopy, small for gestational dates, preterm birth, type 1 diabetes mellitus, low birthweight, serum calcium concentration, blood pressure and rickets; mother - pre-eclampsia, gestational diabetes mellitus, risk of caesarean section and bacterial vaginosis., Results: Seventy-six studies were included. There was considerable heterogeneity between the studies and for most outcomes there was conflicting evidence. The evidence base was insufficient to reliably answer question 1 in relation to biochemical or disease outcomes. For questions 2 and 3, modest positive relationships were identified between maternal 25(OH)D and (1) offspring birthweight in meta-analysis of three observational studies using log-transformed 25(OH)D concentrations after adjustment for potential confounding factors [pooled regression coefficient 5.63 g/10% change maternal 25(OH)D, 95% confidence interval (CI) 1.11 to 10.16 g], but not in those four studies using natural units, or across intervention studies; (2) offspring cord blood or postnatal calcium concentrations in a meta-analysis of six intervention studies (all found to be at high risk of bias; mean difference 0.05 mmol/l, 95% CI 0.02 to 0.05 mmol/l); and (3) offspring bone mass in observational studies judged to be of good quality, but which did not permit meta-analysis. The evidence base was insufficient to reliably answer questions 4 and 5., Limitations: Study methodology varied widely in terms of study design, population used, vitamin D status assessment, exposure measured and outcome definition., Conclusions: The evidence base is currently insufficient to support definite clinical recommendations regarding vitamin D supplementation in pregnancy. Although there is modest evidence to support a relationship between maternal 25(OH)D status and offspring birthweight, bone mass and serum calcium concentrations, these findings were limited by their observational nature (birthweight, bone mass) or risk of bias and low quality (calcium concentrations). High-quality randomised trials are now required., Study Registration: This study is registered as PROSPERO CRD42011001426., Funding: The National Institute for Health Research Health Technology Assessment programme.