Publications by authors named "Natasha Mitchell"

36 Publications

"Lest we forget": An overview of Australia's response to the recovery and identification of unrecovered historic military remains.

Forensic Sci Int 2021 Oct 4;328:111042. Epub 2021 Oct 4.

School of Archaeology and Anthropology, Australian National University, Canberra, ACT, Australia; School of Geosciences, University of Aberdeen, Aberdeen, United Kingdom.

The Australian Defence Force (ADF) is responsible for the recovery and identification of its historic casualties. With over 30,000 still unrecovered from past conflicts including World War One (WW1) and World War Two (WWII), the Australian Army and Royal Australian Air Force have teams that research, recover, identify and oversee the burial (or reburial) of the remains of soldiers and airmen who continue to be found each year. The Royal Australian Navy is also responsible for its unrecovered casualties. Collectively the priorities of the various services within the ADF are the respectful recovery and treatment of the dead, thorough forensic identification efforts, resolution for families and honouring the ADF's proud history of service and sacrifice. What is unique about the approach of the ADF is that the respective services retain responsibility for their historic losses, while a joint approach is taken on policies and in the utilisation of the pool of forensic specialists. Section One describes the process undertaken by the Australian Army in the recovery, identification and burial or repatriation of soldiers through its specialised unit Unrecovered War Casualties - Army (UWC-A). Section Two describes the role of the Royal Australian Air Force in the recovery of aircraft and service personnel through their specialised unit Historic Unrecovered War Casualties - Air Force (HUWC-AF). An overview of the operations of each service and case studies is presented for each section.
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http://dx.doi.org/10.1016/j.forsciint.2021.111042DOI Listing
October 2021

Assessment of Diamond™ Nucleic Acid Dye for the identification and targeted sampling of latent DNA in operational casework.

Forensic Sci Int Genet 2021 Aug 21;55:102579. Epub 2021 Aug 21.

Forensic Science SA, GPO Box 2790, Adelaide, South Australia 5001, Australia; College of Science and Engineering, Flinders University of South Australia, Bedford Park, South Australia 5042, Australia. Electronic address:

Recovery and DNA profiling of latent touch DNA deposits is a ubiquitous practice by operational forensic laboratories that provides critical evidence in many criminal investigations. Despite recent improvements in the sensitivity of contemporary DNA profiling kits, the inability to localise and visually quantify touch DNA deposits on an exhibit means that ineffective or unwarranted sampling is often performed leading to poor success. Diamond™ Nucleic Acid Dye (DD) is a fluorescent DNA binding dye which has recently been shown to bind to corneocytes enabling visualisation and targeted sampling of touch DNA deposits under controlled conditions. The ability to translate these findings to operational casework, where a diverse range of substrates is encountered and the amount and distribution of touch DNA is uncontrolled, is currently unknown. Here, we provide the first report on the use of DD in an operational context. Spraying items with DD was shown to have no impact on downstream immunological testing, DNA extraction, or DNA profiling with the GlobalFiler™ PCR amplification kit. DD was shown to effectively locate areas of touch DNA on select exhibits using the Polilight. Issues with background fluorescence, non-specific staining, interference from fingerprint enhancement reagents, or absorbance of the excitation light by black surfaces demonstrated that DD is not compatible with all exhibits. Background fluorescence also prevented the use of DD to screen for the presence of cellular material on IsoHelix swabs post-sampling but it was suitable for screening Lovell DNA tapelifts. A casework trial of 49 plastic bag and tape exhibits showed limited application of DD to triage out negative items as DNA was recovered from items where DD fluorescence was not detected. Where DD fluorescence was detected, its broad distribution prevented targeted sampling and any correlation to be made between the amount observed and DNA yield or profiling outcome. The DD procedure also increased the time taken to search exhibits and risk of inadvertent contamination. Our study suggests that DD is not suited as a generalised screening technique across all touch casework exhibits but further investigation is warranted to determine its applicability to specific exhibit types.
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http://dx.doi.org/10.1016/j.fsigen.2021.102579DOI Listing
August 2021

STEPFORWARD study: a randomised controlled feasibility trial of a self-aligning prosthetic ankle-foot for older patients with vascular-related amputations.

BMJ Open 2021 03 18;11(3):e045195. Epub 2021 Mar 18.

York Trials Unit, Department of Health Sciences, University of York, York, UK.

Objectives: To determine the feasibility of conducting a full-scale randomised controlled trial (RCT) of the effectiveness and cost-effectiveness of a self-aligning prosthetic ankle-foot compared with a standard prosthetic ankle-foot.

Design: Multicentre parallel group feasibility RCT.

Setting: Five prosthetics centres in England recruiting from July 2018 to August 2019.

Participants: Adults aged ≥50 years with a vascular-related or non-traumatic transtibial amputation for 1 year or longer, categorised as having 'limited community mobility' and using a non-self-aligning ankle-foot.

Intervention: Participants were randomised into one of two groups for 12 weeks: self-aligning prosthetic ankle-foot or existing non-self-aligning prosthetic ankle-foot.

Outcomes: Feasibility measures: recruitment, consent and retention rates; and completeness of questionnaire and clinical assessment datasets across multiple time points. Feasibility of collecting daily activity data with wearable technology and health resource use data with a bespoke questionnaire.

Results: Fifty-five participants were randomised (61% of the target 90 participants): n=27 self-aligning ankle-foot group, n=28 non-self-aligning ankle-foot group. Fifty-one participants were included in the final analysis (71% of the target number of participants). The consent rate and retention at final follow-up were 86% and 93%, respectively. The average recruitment rate was 1.25 participants/site/month (95% CI 0.39 to 2.1). Completeness of questionnaires ranged from 89%-94%, and clinical assessments were 92%-95%, including the activity monitor data. The average completion rates for the EQ-5D-5L and bespoke resource use questionnaire were 93% and 63%, respectively.

Conclusions: This feasibility trial recruited and retained participants who were categorised as having 'limited community mobility' following a transtibial amputation. The high retention rate of 93% indicated the trial was acceptable to participants and feasible to deliver as a full-scale RCT. The findings support a future, fully powered evaluation of the effectiveness and cost-effectiveness of a self-aligning prosthetic ankle-foot compared with a standard non-self-aligning version with some adjustments to the trial design and delivery.

Trial Registration Number: ISRCTN15043643.
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http://dx.doi.org/10.1136/bmjopen-2020-045195DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7978257PMC
March 2021

Comparative performance of the Phadebas® Forensic Press Test at room temperature and 37 °C for the detection of saliva stains on fabric exhibits.

Sci Justice 2021 Mar 21;61(2):170-174. Epub 2020 Nov 21.

Forensic Science SA, GPO Box 2790, Adelaide, South Australia 5001, Australia; College of Science and Engineering, Flinders University of South Australia, Bedford Park, South Australia 5042, Australia. Electronic address:

The Phadebas® Forensic Press Test (PFPT) is an enzyme-based colorimetric test used to visualise and locate latent saliva stains on forensic exhibits. The test relies upon the presence of the enzyme α-amylase which is present in high levels in saliva. Even though the optimal in vitro temperature for α-amylase activity is 37 °C, the PFPT manufacturer's protocol specifies that the PFPT should be carried out at room temperature (RT). In this study, we compared the performance of the PFPT at RT and 37 °C using combinations of four fabric types (cotton, polyester, acrylic and a cotton/polyester blend), three saliva dilutions (neat, 1:10 and 1:100) and stains aged for four time periods (1 day, 1 week, 1 month and 3 months). The intensity of the PFPT colour reactions at RT and 37 °C were not statistically different across all fabric types, saliva concentrations and stain ages, indicating that maximum sensitivity and performance of the PFPT can be achieved at RT.
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http://dx.doi.org/10.1016/j.scijus.2020.11.001DOI Listing
March 2021

Magnetic Resonance Imaging Correlates of White Matter Gliosis and Injury in Preterm Fetal Sheep Exposed to Progressive Systemic Inflammation.

Int J Mol Sci 2020 Nov 24;21(23). Epub 2020 Nov 24.

Department of Physiology, University of Auckland, Auckland 1023, New Zealand.

Progressive fetal infection/inflammation is strongly associated with neural injury after preterm birth. We aimed to test the hypotheses that progressively developing fetal inflammation leads to neuroinflammation and impaired white matter development and that the histopathological changes can be detected using high-field diffusion tensor magnetic resonance imaging (MRI). Chronically instrumented preterm fetal sheep at 0.7 of gestation were randomly assigned to receive intravenous saline (control; = 6) or a progressive infusion of lipopolysaccharide (LPS, 200 ng intravenous over 24 h then doubled every 24 h for 5 days to induce fetal inflammation, = 7). Sheep were killed 10 days after starting the infusions, for histology and high-field diffusion tensor MRI. Progressive LPS infusion was associated with increased circulating interleukin (IL)-6 concentrations and moderate increases in carotid artery perfusion and the frequency of electroencephalogram (EEG) activity ( < 0.05 vs. control). In the periventricular white matter, fractional anisotropy (FA) was increased, and orientation dispersion index (ODI) was reduced ( < 0.05 vs. control for both). Histologically, in the same brain region, LPS infusion increased microglial activation and astrocyte numbers and reduced the total number of oligodendrocytes with no change in myelination or numbers of immature/mature oligodendrocytes. Numbers of astrocytes in the periventricular white matter were correlated with increased FA and reduced ODI signal intensities. Astrocyte coherence was associated with increased FA. Moderate astrogliosis, but not loss of total oligodendrocytes, after progressive fetal inflammation can be detected with high-field diffusion tensor MRI.
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http://dx.doi.org/10.3390/ijms21238891DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7727662PMC
November 2020

The RESPECT study: a feasibility randomised controlled trial of a sexual health promotion intervention for people with serious mental illness in community mental health services in the UK.

BMC Public Health 2020 Nov 17;20(1):1736. Epub 2020 Nov 17.

Department of Health Sciences, University of York, York, England.

Background: People with serious mental illness (SMI) have sexual health needs but there is little evidence to inform effective interventions to address them. In fact, there are few studies that have addressed this topic for people with SMI outside USA and Brazil. Therefore, the aim of the study was to establish the acceptability and feasibility of a trial of a sexual health promotion intervention for people with SMI in the UK.

Method: The RESPECT study was a two-armed randomised controlled, open feasibility trial (RCT) comparing Sexual health promotion intervention (3 individual sessions of 1 h) (I) or treatment as usual (TAU) for adults aged 18 or over, with SMI, within community mental health services in four UK cities. The main outcome of interest was the percentage who consented to participate, and retained in each arm of the trial, retention for the intervention, and completeness of data collection. A nested qualitative study obtained the views of participants regarding the acceptability of the study using individual telephone interviews conducted by lived experience researchers.

Results: Of a target sample of 100, a total of 72 people were enrolled in the trial over 12 months. Recruitment in the initial months was low and so an extension was granted. However this extension meant that the later recruited participants would only be followed up to the 3 month point. There was good retention in the intervention and the study as a whole; 77.8% of those allocated to intervention (n = 28) received it. At three months, 81.9% (30 I; 29 TAU) and at 6 months, 76.3% (13 I and 16 TAU) completed the follow-up data collection. No adverse events were reported. There was good completeness of the data. The sexual health outcomes for the intervention group changed in favour of the intervention. Based on analysis of the qualitative interviews, the methods of recruitment, the quality of the participant information, the data collection, and the intervention were deemed to be acceptable to the participants (n = 22).

Conclusions: The target of 100 participants was not achieved within the study's timescale. However, effective strategies were identified that improved recruitment in the final few months. Retention rates and completeness of data in both groups indicate that it is acceptable and feasible to undertake a study promoting sexual health for people with SMI. A fully powered RCT is required to establish effectiveness of the intervention in adoption of safer sex.

Study Registration: ISRCTN Registry ISRCTN15747739 prospectively registered 5th July 2016.
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http://dx.doi.org/10.1186/s12889-020-09661-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7673083PMC
November 2020

Optimised patient information materials and recruitment to a study of behavioural activation in older adults: an embedded study within a trial.

F1000Res 2020 21;9:417. Epub 2020 May 21.

Department of Health Sciences and the Hull York Medical School, University of York,, York, UK.

Printed participant information about randomised controlled trials is often long, technical and difficult to navigate. Improving information materials is possible through optimisation and user-testing, and may impact on participant understanding and rates of recruitment. A study within a trial (SWAT) was undertaken within the CASPER trial. Potential CASPER participants were randomised to receive either the standard trial information or revised information that had been optimised through information design and user testing. A total of 11,531 patients were randomised in the SWAT. Rates of recruitment to the CASPER trial were 2.0% in the optimised information group and 1.9% in the standard information group (odds ratio 1.027; 95% CI 0.79 to 1.33; p=0.202). Participant information that had been optimised through information design and user testing did not result in any change to rate of recruitment to the host trial. ISRCTN ID ISRCTN02202951; registered on 3 June 2009.
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http://dx.doi.org/10.12688/f1000research.24051.1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7400690PMC
March 2021

Feasibility study of early outpatient review and early cardiac rehabilitation after cardiac surgery: mixed-methods research design-a study protocol.

BMJ Open 2019 12 29;9(12):e035787. Epub 2019 Dec 29.

York Trials Unit, Department of Health Sciences, University of York, York, UK.

Introduction: Following cardiac surgery, patients currently attend an outpatient review 6 weeks after hospital discharge, where recovery is assessed and suitability to commence cardiac rehabilitation (CR) is determined. CR is then started from 8 weeks. Following a median sternotomy, cardiac surgery patients are required to refrain from upper body exercises, lifting of heavy objects and other strenuous activities for 12 weeks. A delay in starting CR can prolong the recovery process, increase dependence on family/carers and can cause frustration. However, current guidelines for activity and exercise after median sternotomy have been described as restrictive, anecdotal and increasingly at odds with modern clinical guidance for CR. This study aims to examine the feasibility of bringing forward outpatient review and starting CR earlier.

Methods And Analyses: This is a multicentre, randomised controlled, open feasibility trial comparing postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control arm) versus, postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention arm). The study aims to recruit 100 eligible patients, aged 18-80 years who have undergone elective or urgent cardiac surgery involving a full median sternotomy, over a 7-month period across two centres. Feasibility will be measured by consent, recruitment, retention rates and attendance at appointments and CR sessions. Qualitative interviews with trial participants and staff will explore issues around study processes and acceptability of the intervention and the findings integrated with the feasibility trial outcomes to inform the design of a future full-scale randomised controlled trial.

Ethics And Dissemination: Ethics approval was granted by East Midlands-Derby Research Ethics Committee on 10 January 2019. The findings will be presented at relevant conferences disseminated via peer-reviewed research publications, and to relevant stakeholders.

Trial Registration Number: ISRCTN80441309.
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http://dx.doi.org/10.1136/bmjopen-2019-035787DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6937080PMC
December 2019

Sexual health promotion in people with severe mental illness: the RESPECT feasibility RCT.

Health Technol Assess 2019 12;23(65):1-136

Department of Health Sciences, University of York, York, UK.

Background: People with serious mental illness have sexual health needs, but there is limited evidence regarding effective interventions to promote their sexual health.

Objectives: To develop a sexual health promotion intervention for people with serious mental illness, and to conduct a feasibility trial in order to establish the acceptability and parameters for a fully powered trial.

Design: A two-armed randomised controlled, open feasibility study comparing usual care alone with usual care plus the adjunctive intervention.

Setting: Five community mental health providers in Leeds, Barnsley, Brighton and London.

Participants: Adults aged ≥ 18 years with serious mental illness and receiving care from community mental health teams.

Interventions: A remote, web-based computer randomisation system allocated participants to usual care plus the RESPECT (Randomised Evaluation of Sexual health Promotion Effectiveness informing Care and Treatment) intervention (three sessions of 1 hour) (intervention arm) or usual care only (control arm). The intervention was an interactive manualised package of exercises, quizzes and discussion topics focusing on knowledge, motivation and behavioural intentions to adopt safer sexual behaviours.

Main Outcome Measures: Feasibility parameters including establishing the percentage of people who were eligible, consented and were retained in each arm of the trial, retention for the intervention, as well as the completeness of the data collection. Data were collected on knowledge, motivation to adopt safer sexual behaviour, sexual behaviour, sexual stigma, sexual health service use and quality of life. Data were collected at baseline and then at 3 months and 6 months post randomisation.

Results: Of a target of 100 participants, 72 people participated in the trial over 12 months. Of the 36 participants randomised to the intervention arm, 27 received some of the intervention (75.0%). At 3 months, 59 of the 72 participants completed follow-up questionnaires (81.9%) (30 participants from the intervention arm and 29 participants from the control arm). Only the first 38 participants were followed up at 6 months. However, data were collected on 29 out of 38 participants (76.3% retention): 13 in the intervention arm and 16 in the control arm. No adverse events were reported. Participant feedback confirmed that both the design and the intervention were acceptable. The economic analysis indicated high completion rates and completeness of data among participants who continued the trial.

Conclusions: Despite the limitations, the findings suggest that it is both acceptable and feasible to undertake a sexual health promotion study for people with serious mental illness.

Future Work: A fully powered randomised controlled trial would be required to establish the clinical effectiveness of the intervention.

Trial Registration: Current Controlled Trials ISRCTN15747739.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 23, No. 65. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta23650DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6936169PMC
December 2019

Self-aligning prosthetic device for older patients with vascular-related amputations: protocol for a randomised feasibility study (the STEPFORWARD study).

BMJ Open 2019 09 20;9(9):e032924. Epub 2019 Sep 20.

Department of Sport, Health and Exercise Science, University of Hull, Hull, UK

Introduction: The majority of older patients with a transtibial amputation are prescribed a standard (more rigid, not self-aligning) prosthesis. These are mostly suitable for level walking, and cannot adjust to different sloped surfaces. This makes walking more difficult and less energy efficient, possibly leading to longer term disuse. A Cochrane Review concluded that there was insufficient evidence to recommend any individual type of prosthetic ankle-foot mechanism. This trial will establish the feasibility of conducting a large-scale trial to assess the effectiveness and cost-effectiveness of a self-aligning prosthesis for older patients with vascular-related amputations and other health issues compared with a standard prosthesis.

Methods And Analysis: This feasibility trial is a pragmatic, parallel group, randomised controlled trial (RCT) comparing standard treatment with a more rigid prosthesis versus a self-aligning prosthesis. The target sample size is 90 patients, who are aged 50 years and over, and have a transtibial amputation, where amputation aetiology is mostly vascular-related or non-traumatic. Feasibility will be measured by consent and retention rates, a plausible future sample size over a 24-month recruitment period and completeness of outcome measures. Qualitative interviews will be carried out with trial participants to explore issues around study processes and acceptability of the intervention. Focus groups with staff at prosthetics centres will explore barriers to successful delivery of the trial. Findings from the qualitative work will be integrated with the feasibility trial outcomes in order to inform the design of a full-scale RCT.

Ethics And Dissemination: Ethical approval was granted by Yorkshire and the Humber-Leeds West Research Ethics Committee on 4 May 2018. The findings will be disseminated via peer-reviewed research publications, articles in relevant newsletters, presentations at relevant conferences and the patient advisory group.

Trial Registration Number: ISRCTN15043643.
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http://dx.doi.org/10.1136/bmjopen-2019-032924DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6756612PMC
September 2019

A risk-based approach to cognitive bias in forensic science.

Sci Justice 2019 09 30;59(5):533-543. Epub 2019 Apr 30.

Forensic Science SA, GPO Box 2790, Adelaide, SA 5001, Australia.

Over the past decade, the potential impact of cognitive bias in forensic science has instigated much discussion and debate between academics, scientists and those in the justice sector. Evidence of bias influencing subjective decision-making across a range of forensic disciplines has been described in the literature. Forensic service organisations are being urged to address cognitive bias in subjective decision-making by designing processes or procedures to limit access to (irrelevant) contextual information or reduce dependence on cognitive functions. Although some laboratories have implemented bias mitigating strategies, with varying impact on operational efficiency, there has been no systematic assessment of the risk posed by cognitive bias. Forensic Science SA assessed the potential impact of bias on forensic interpretations across multiple disciplines, using a risk management framework. This process proved useful in assessing the effectiveness of existing bias mitigating strategies and identified the latent level of risk posed. While all forensic organisations should seek to implement bias limiting measures that are simple, cost-effective and do not adversely impact efficiency, using a risk-based approach has contextualised the limited benefit of introducing resource hungry measures, as postulated in the literature. That is not to suggest that forensic organisations should dismiss the potential influence of cognitive bias but they need to strike an appropriate balance between risk and return, as they do with any business risk.
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http://dx.doi.org/10.1016/j.scijus.2019.04.003DOI Listing
September 2019

Implementing mental health training programmes for non-mental health trained professionals: A qualitative synthesis.

PLoS One 2018 25;13(6):e0199746. Epub 2018 Jun 25.

York Trials Unit, Department of Health Sciences, University of York, York, England.

Introduction: Given the prevalence of mental health problems globally, there is an increasing need for the police and other non-mental health trained professionals to identify and manage situations involving individuals with mental health problems. The review aimed to identify and explore qualitative evidence on views and experiences of non-mental health professionals receiving mental health training and the barriers and facilitators to training delivery and implementation.

Methods: A meta-synthesis of qualitative evidence on the barriers, facilitators and perceived impact of mental health training programmes for non-mental health trained professionals. Systematic literature searches were undertaken of the following databases: Criminal Justice Abstracts (CJA); MEDLINE; Embase; PsycINFO; ASSIA; CENTRAL; SSCI; ERIC; Campbell Library; Social Care Online and EPOC from 1995 to 2016. Records were independently screened for eligibility by two researchers, data extraction and quality appraisal of studies was also undertaken independently by two researchers. The CASP tool was used to quality appraise included studies. Included studies were synthesised using a meta-ethnographic approach as outlined by Noblit and Hare.

Results: 10,282 records were identified and eight qualitative studies were included. A range of barriers and facilitators to training were identified and related to the delivery and content of training; the use of additional resources; and staff willingness to engage with training and organisational factors. The perceived impact of training was also discussed in terms of how it affects trainees; perceptions of mental health; self-perception; responses to situations involving mental health and the potential of training to reduce injury or physical harm in situations involving mental health. The value of training and how to measure its impact were also discussed.

Conclusion: Findings from this review have implications for those designing, implementing and evaluating mental health training programmes. It is recommended that research evaluating mental health training includes a qualitative component to ensure that the barriers and facilitators to training and its impact on trainees' perceptions of mental health are understood.

Protocol Registration Number: PROSPERO: CRD42015015981.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0199746PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6016927PMC
December 2018

CollAborative care for Screen-Positive EldeRs with major depression (CASPER plus): a multicentred randomised controlled trial of clinical effectiveness and cost-effectiveness.

Health Technol Assess 2017 11;21(67):1-252

Department of Health Sciences, University of York, York, UK.

Background: Depression in older adults is common and is associated with poor quality of life, increased morbidity and early mortality, and increased health and social care use. Collaborative care, a low-intensity intervention for depression that is shown to be effective in working-age adults, has not yet been evaluated in older people with depression who are managed in UK primary care. The CollAborative care for Screen-Positive EldeRs (CASPER) plus trial fills the evidence gap identified by the most recent guidelines on depression management.

Objectives: To establish the clinical effectiveness and cost-effectiveness of collaborative care for older adults with major depressive disorder in primary care.

Design: A pragmatic, multicentred, two-arm, parallel, individually randomised controlled trial with embedded qualitative study. Participants were automatically randomised by computer, by the York Trials Unit Randomisation Service, on a 1 : 1 basis using simple unstratified randomisation after informed consent and baseline measures were collected. Blinding was not possible.

Setting: Sixty-nine general practices in the north of England.

Participants: A total of 485 participants aged ≥ 65 years with major depressive disorder.

Interventions: A low-intensity intervention of collaborative care, including behavioural activation, delivered by a case manager for an average of six sessions over 7-8 weeks, alongside usual general practitioner (GP) care. The control arm received only usual GP care.

Main Outcome Measures: The primary outcome measure was Patient Health Questionnaire-9 items score at 4 months post randomisation. Secondary outcome measures included depression severity and caseness at 12 and 18 months, the EuroQol-5 Dimensions, Short Form questionnaire-12 items, Patient Health Questionnaire-15 items, Generalised Anxiety Disorder-7 items, Connor-Davidson Resilience Scale-2 items, a medication questionnaire, objective data and adverse events. Participants were followed up at 12 and 18 months.

Results: In total, 485 participants were randomised (collaborative care,  = 249; usual care,  = 236), with 390 participants (80%: collaborative care, 75%; usual care, 86%) followed up at 4 months, 358 participants (74%: collaborative care, 70%; usual care, 78%) followed up at 12 months and 344 participants (71%: collaborative care, 67%; usual care, 75%) followed up at 18 months. A total of 415 participants were included in primary analysis (collaborative care,  = 198; usual care,  = 217), which revealed a statistically significant effect in favour of collaborative care at the primary end point at 4 months [8.98 vs. 10.90 score points, mean difference 1.92 score points, 95% confidence interval (CI) 0.85 to 2.99 score points;    0.001], equivalent to a standard effect size of 0.34. However, treatment differences were not maintained in the longer term (at 12 months: 0.19 score points, 95% CI -0.92 to 1.29 score points;  = 0.741; at 18 months: < 0.01 score points, 95% CI -1.12 to 1.12 score points;  = 0.997). The study recorded details of all serious adverse events (SAEs), which consisted of 'unscheduled hospitalisation', 'other medically important condition' and 'death'. No SAEs were related to the intervention. Collaborative care showed a small but non-significant increase in quality-adjusted life-years (QALYs) over the 18-month period, with a higher cost. Overall, the mean cost per incremental QALY for collaborative care compared with usual care was £26,016; however, for participants attending six or more sessions, collaborative care appears to represent better value for money (£9876/QALY).

Limitations: Study limitations are identified at different stages: design (blinding unfeasible, potential contamination), process (relatively low overall consent rate, differential attrition/retention rates) and analysis (no baseline health-care resource cost or secondary/social care data).

Conclusion: Collaborative care was effective for older people with case-level depression across a range of outcomes in the short term though the reduction in depression severity was not maintained over the longer term of 12 or 18 months. Participants who received six or more sessions of collaborative care did benefit substantially more than those who received fewer treatment sessions but this difference was not statistically significant.

Future Work Recommendations: Recommendations for future research include investigating the longer-term effect of the intervention. Depression is a recurrent disorder and it would be useful to assess its impact on relapse and the prevention of future case-level depression.

Trial Registration: Current Controlled Trials ISRCTN45842879.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 21, No. 67. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta21670DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6983908PMC
November 2017

Mental health training programmes for non-mental health trained professionals coming into contact with people with mental ill health: a systematic review of effectiveness.

BMC Psychiatry 2017 05 25;17(1):196. Epub 2017 May 25.

York Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Helslington, York, YO10 5DD, UK.

Background: The police and others in occupations where they come into close contact with people experiencing/with mental ill health, often have to manage difficult and complex situations. Training is needed to equip them to recognise and assist when someone has a mental health issue or learning/intellectual disability. We undertook a systematic review of the effectiveness of training programmes aimed at increasing knowledge, changing behaviour and/or attitudes of the trainees with regard to mental ill health, mental vulnerability, and learning disabilities.

Methods: Databases searched from 1995 onwards included: ASSIA, Cochrane Central Register of Controlled Clinical Trials (CENTRAL), Criminal Justice Abstracts, Embase, ERIC, MEDLINE, PsycINFO, Social Science Citation Index. Courses, training, or learning packages aimed at helping police officers and others who interact with the public in a similar way to deal with people with mental health problems were included. Primary outcomes were change in practice and change in outcomes for the groups of people the trainees come into contact with. Systematic reviews, randomised controlled trials (RCTs) and non- randomised controlled trials (non-RCTs) were included and quality assessed. In addition non-comparative evaluations of training for police in England were included.

Results: From 8578 search results, 19 studies met the inclusion criteria: one systematic review, 12 RCTs, three prospective non-RCTs, and three non-comparative studies. The training interventions identified included broad mental health awareness training and packages addressing a variety of specific mental health issues or conditions. Trainees included police officers, teachers and other public sector workers. Some short term positive changes in behaviour were identified for trainees, but for the people the trainees came into contact with there was little or no evidence of benefit.

Conclusions: A variety of training programmes exist for non-mental health professionals who come into contact with people who have mental health issues. There may be some short term change in behaviour for the trainees, but longer term follow up is needed. Research evaluating training for UK police officers is needed in which a number of methodological issues need to be addressed.

Trial Registration: Protocol registration number: PROSPERO: CRD42015015981 .
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http://dx.doi.org/10.1186/s12888-017-1356-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5445268PMC
May 2017

CollAborative care and active surveillance for Screen-Positive EldeRs with subthreshold depression (CASPER): a multicentred randomised controlled trial of clinical effectiveness and cost-effectiveness.

Health Technol Assess 2017 02;21(8):1-196

Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.

Background: Efforts to reduce the burden of illness and personal suffering associated with depression in older adults have focused on those with more severe depressive syndromes. Less attention has been paid to those with mild disorders/subthreshold depression, but these patients also suffer significant impairments in their quality of life and level of functioning. There is currently no clear evidence-based guidance regarding treatment for this patient group.

Objectives: To establish the clinical effectiveness and cost-effectiveness of a low-intensity intervention of collaborative care for primary care older adults who screened positive for subthreshold depression.

Design: A pragmatic, multicentred, two-arm, parallel, individually randomised controlled trial with a qualitative study embedded within the pilot. Randomisation occurred after informed consent and baseline measures were collected.

Setting: Thirty-two general practitioner (GP) practices in the north of England.

Participants: A total of 705 participants aged ≥ 75 years during the pilot phase and ≥ 65 years during the main trial with subthreshold depression.

Interventions: Participants in the intervention group received a low-intensity intervention of collaborative care, which included behavioural activation delivered by a case manager for an average of six sessions over 7-8 weeks, alongside usual GP care. Control-arm participants received only usual GP care.

Main Outcome Measures: The primary outcome measure was a self-reported measure of depression severity, the Patient Health Questionnaire-9 items PHQ-9 score at 4 months post randomisation. Secondary outcome measures included the European Quality of Life-5 Dimensions, Short Form questionnaire-12 items, Patient Health Questionnaire-15 items, Generalised Anxiety Disorder seven-item scale, Connor-Davidson Resilience Scale two-item version, a medication questionnaire and objective data. Participants were followed up for 12 months.

Results: In total, 705 participants were randomised (collaborative care  = 344, usual care  = 361), with 586 participants (83%; collaborative care 76%, usual care 90%) followed up at 4 months and 519 participants (74%; collaborative care 68%, usual care 79%) followed up at 12 months. Attrition was markedly greater in the collaborative care arm. Model estimates at the primary end point of 4 months revealed a statistically significant effect in favour of collaborative care compared with usual care [mean difference 1.31 score points, 95% confidence interval (CI) 0.67 to 1.95 score points;  < 0.001]. The difference equates to a standard effect size of 0.30, for which the trial was powered. Treatment differences measured by the PHQ-9 were maintained at 12 months' follow-up (mean difference 1.33 score points, 95% CI 0.55 to 2.10 score points;  = 0.001). Base-case cost-effectiveness analysis found that the incremental cost-effectiveness ratio was £9633 per quality-adjusted life-year (QALY). On average, participants allocated to collaborative care displayed significantly higher QALYs than those allocated to the control group (annual difference in adjusted QALYs of 0.044, 95% bias-corrected CI 0.015 to 0.072;  = 0.003).

Conclusions: Collaborative care has been shown to be clinically effective and cost-effective for older adults with subthreshold depression and to reduce the proportion of people who go on to develop case-level depression at 12 months. This intervention could feasibly be delivered in the NHS at an acceptable cost-benefit ratio. Important future work would include investigating the longer-term effect of collaborative care on the CASPER population, which could be conducted by introducing an extension to follow-up, and investigating the impact of collaborative care on managing multimorbidities in people with subthreshold depression.

Trial Registration: Current Controlled Trials ISRCTN02202951.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 21, No. 8. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta21080DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5346884PMC
February 2017

Effect of Collaborative Care vs Usual Care on Depressive Symptoms in Older Adults With Subthreshold Depression: The CASPER Randomized Clinical Trial.

JAMA 2017 02;317(7):728-737

Department of Health Sciences, University of York, Heslington, England.

Importance: There is little evidence to guide management of depressive symptoms in older people.

Objective: To evaluate whether a collaborative care intervention can reduce depressive symptoms and prevent more severe depression in older people.

Design, Setting, And Participants: Randomized clinical trial conducted from May 24, 2011, to November 14, 2014, in 32 primary care centers in the United Kingdom among 705 participants aged 65 years or older with Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) subthreshold depression; participants were followed up for 12 months.

Interventions: Collaborative care (n=344) was coordinated by a case manager who assessed functional impairments relating to mood symptoms. Participants were offered behavioral activation and completed an average of 6 weekly sessions. The control group received usual primary care (n=361).

Main Outcomes And Measures: The primary outcome was self-reported depression severity at 4-month follow-up on the 9-item Patient Health Questionnaire (PHQ-9; score range, 0-27). Included among 10 prespecified secondary outcomes were the PHQ-9 score at 12-month follow-up and the proportion meeting criteria for depressive disorder (PHQ-9 score ≥10) at 4- and 12-month follow-up.

Results: The 705 participants were 58% female with a mean age of 77 (SD, 7.1) years. Four-month retention was 83%, with higher loss to follow-up in collaborative care (82/344 [24%]) vs usual care (37/361 [10%]). Collaborative care resulted in lower PHQ-9 scores vs usual care at 4-month follow-up (mean score with collaborative care, 5.36 vs with usual care, 6.67; mean difference, -1.31; 95% CI, -1.95 to -0.67; P < .001). Treatment differences remained at 12 months (mean PHQ-9 score with collaborative care, 5.93 vs with usual care, 7.25; mean difference, -1.33; 95% CI, -2.10 to -0.55). The proportions of participants meeting criteria for depression at 4-month follow-up were 17.2% (45/262) vs 23.5% (76/324), respectively (difference, -6.3% [95% CI, -12.8% to 0.2%]; relative risk, 0.83 [95% CI, 0.61-1.27]; P = .25) and at 12-month follow-up were 15.7% (37/235) vs 27.8% (79/284) (difference, -12.1% [95% CI, -19.1% to -5.1%]; relative risk, 0.65 [95% CI, 0.46-0.91]; P = .01).

Conclusions And Relevance: Among older adults with subthreshold depression, collaborative care compared with usual care resulted in a statistically significant difference in depressive symptoms at 4-month follow-up, of uncertain clinical importance. Although differences persisted through 12 months, findings are limited by attrition, and further research is needed to assess longer-term efficacy.

Trial Registration: isrctn.org Identifier: ISRCTN02202951.
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http://dx.doi.org/10.1001/jama.2017.0130DOI Listing
February 2017

Enclosing a pen reduced time to response to questionnaire mailings.

J Clin Epidemiol 2016 06 29;74:144-50. Epub 2015 Dec 29.

York Trials Unit, Health Sciences Department, University of York, York YO10 5DD, UK.

Objectives: To assess the effectiveness of including a pen in postal questionnaires on response rate, necessity of reminders, time to response, and completeness of response to the primary outcome question (POQ).

Study Design And Setting: A two-arm randomized controlled trial (RCT) embedded within the screening of older women for prevention of fracture trial (SCOOP). Women, aged 70-75 years, were randomized to receive a pen with their questionnaire (n = 3,826) or to receive the questionnaire alone (n = 3,829). The results were combined with another embedded RCT in a meta-analysis.

Results: A response rate of 92.4% was observed in the pen group compared with 91.3% in the control group (odds ratio [OR] = 1.16; 95% confidence interval [CI]: 0.98, 1.37; P = 0.08). There was a difference in reminders required (OR = 0.88; 95% CI: 0.79, 0.98; P = 0.02), time to response (hazard ratio = 1.06; 95% CI: 1.01, 1.11; P = 0.01) and some difference in the completeness of response to the POQ (OR = 1.18; 95% CI: 1.00, 1.39; P = 0.05). The pooled OR from the meta-analysis for response rate was 1.21 (95% CI: 1.05, 1.39; P = 0.01).

Conclusion: Inclusion of a pen with postal questionnaires potentially has a positive impact on response rates and the number of reminders required. There may be some reduction in time to response. Studies of different participant groups are needed to test the effectiveness over more diverse populations.
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http://dx.doi.org/10.1016/j.jclinepi.2015.12.004DOI Listing
June 2016

Bespoke smoking cessation for people with severe mental ill health (SCIMITAR): a pilot randomised controlled trial.

Lancet Psychiatry 2015 May 28;2(5):395-402. Epub 2015 Apr 28.

Faculty of Health & Social Care, University of Hull, Hull, UK.

Background: People with severe mental ill health are three times more likely to smoke but typically do not access conventional smoking cessation services, contributing to widening health inequalities and reduced life expectancy. We aimed to pilot an intervention targeted at smokers with severe mental ill health and to test methods of recruitment, randomisation, and follow up before implementing a full trial.

Methods: The Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR) is a pilot randomised controlled trial of a smoking cessation strategy designed specifically for people with severe mental ill health, to be delivered by mental health nurses and consisting of behavioural support and drugs, compared with a conventional smoking cessation service (ie, usual care). Adults (aged 18 years or older) with bipolar disorder or schizophrenia, who were current smokers, were recruited from NHS primary care and mental health settings in the UK (York, Scarborough, Hull, and Manchester). Eligible participants were randomly allocated to either usual care (control group) or usual care plus the bespoke smoking cessation strategy (intervention group). Randomisation was done via a central telephone system, with computer-generated random numbers. We could not mask participants, family doctors, and researchers to the treatment allocation. Our primary outcome was smoking status at 12 months, verified by carbon monoxide measurements or self-report. Only participants who provided an exhaled CO measurement or self-reported their smoking status at 12 months were included in the primary analysis. The trial is registered at ISRCTN.com, number ISRCTN79497236.

Findings: Of 97 people recruited to the pilot study, 51 were randomly allocated to the control group and 46 were assigned to the intervention group. Participants engaged well with the bespoke smoking cessation strategy, but no individuals assigned to usual care accessed NHS smoking cessation services. At 12 months, 35 (69%) controls and 33 (72%) people assigned to the intervention group provided a CO measurement or self-reported their smoking status. Smoking cessation was highest among individuals who received the bespoke intervention (12/33 [36%] vs 8/35 [23%]; adjusted odds ratio 2·9, 95% CI 0·8-10·5).

Interpretation: We have shown the feasibility of recruiting and randomising people with severe mental ill health in a trial of this nature. The level of engagement with a bespoke smoking cessation strategy was higher than with a conventional approach. The effectiveness and safety of a smoking cessation programme designed particularly for people with severe mental ill health should be tested in a fully powered randomised controlled trial.

Funding: National Institute of Health Research Health Technology Assessment Programme.
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http://dx.doi.org/10.1016/S2215-0366(15)00091-7DOI Listing
May 2015

Diagnostic accuracy of the Whooley depression tool in older adults in UK primary care.

J Affect Disord 2015 Aug 20;182:39-43. Epub 2015 Apr 20.

Department of Health Sciences, Seebohm Rowntree Building, University of York, Heslington, York YO10 5DD, UK; Hull York Medical School, University of York, Heslington, York YO10 5DD, UK.

Purpose Of Research: To validate the Whooley questions as a screening tool for depression amongst a population of older adults in UK primary care.

Objective: To assess the diagnostic performance of the Whooley questions as a screening tool for depression amongst older adults in UK primary care.

Participants: A cross-sectional validation study was conducted with 766 patients aged ≥75 from UK primary care, recruited via 17 general practices based in the North of England during the pilot phase of a randomized controlled trial.

Main Outcome Measures: Sensitivity, specificity and likelihood ratios comparing the index test (two Whooley questions) with a diagnosis of major depressive disorder (MDD) ascertained by the reference standard Mini International Neuropsychiatric Interview (MINI).

Results: The two screening questions had a sensitivity of 94.3% (95% confidence interval, 80.8-99.3%) and specificity of 62.7% (95% confidence interval, 59.0-66.2%). The likelihood ratio for a positive test was 2.5 (95% confidence interval, 2.2-2.9) and the likelihood ratio for a negative test was 0.09 (95% confidence interval, 0.02-0.35).

Conclusion: The two Whooley questions missed few cases of depression. However, they were responsible for a high rate of false positives. This creates additional burden on general practitioners, to conduct more detailed investigation on patients who screen positive, but many of whom turn out not to have MDD.
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http://dx.doi.org/10.1016/j.jad.2015.04.020DOI Listing
August 2015

Smoking Cessation Intervention for severe Mental Ill Health Trial (SCIMITAR): a pilot randomised control trial of the clinical effectiveness and cost-effectiveness of a bespoke smoking cessation service.

Health Technol Assess 2015 Mar;19(25):1-148, v-vi

Department of Health Sciences, University of York, York, UK.

Background: There is a high prevalence of smoking among people who experience severe mental ill health (SMI). Helping people with disorders such as bipolar illness and schizophrenia to quit smoking would help improve their health, increase longevity and also reduce health inequalities. Around half of people with SMI who smoke express an interest in cutting down or quitting smoking. There is limited evidence that smoking cessation can be achieved for people with SMI. Those with SMI rarely access routine NHS smoking cessation services. This suggests the need to develop and evaluate a behavioural support and medication package tailored to the needs of people with SMI.

Objective: The objective in this project was to conduct a pilot trial to establish acceptability of the intervention and to ensure the feasibility of recruitment, randomisation and follow-up. We also sought preliminary estimates of effect size in order to design a fully powered trial of clinical effectiveness and cost-effectiveness. The pilot should inform a fully powered trial to compare the clinical effectiveness and cost-effectiveness of a bespoke smoking cessation (BSC) intervention with usual general practitioner (GP) care for people with SMI.

Design: A pilot pragmatic two-arm individually randomised controlled trial (RCT). Simple randomisation was used following a computer-generated random number sequence. Participants and practitioners were not blinded to allocation.

Setting: Primary care and secondary care mental health services in England.

Participants: Smokers aged > 18 years with a severe mental illness who would like to cut down or quit smoking.

Interventions: A BSC intervention delivered by mental health specialists trained to deliver evidence-supported smoking cessation interventions compared with usual GP care.

Main Outcome Measures: The primary outcome was carbon monoxide-verified smoking cessation at 12 months. Smoking-related secondary outcomes were reduction of number of cigarettes smoked, Fagerstrom test of nicotine dependence and motivation to quit (MTQ). Other secondary outcomes were Patient Health Questionnaire-9 items and Short Form Questionnaire-12 items to assess whether there were improvements or deterioration in mental health and quality of life. We also measured body mass index to assess whether or not smoking cessation was associated with weight gain. These were measured at 1, 6 and 12 months post randomisation.

Results: The trial recruited 97 people aged 19-73 years who smoked between 5 and 60 cigarettes per day (mean 25 cigarettes). Participants were recruited from four mental health trusts and 45 GP surgeries. Forty-six people were randomised to the BSC intervention and 51 people were randomised to usual GP care. The odds of quitting at 12 months was higher in the BSC intervention (36% vs. 23%) but did not reach statistical significance (odds ratio 2.9; 95% confidence interval 0.8% to 10.5%). At 3 and 6 months there was no evidence of difference in self-reported smoking cessation. There was a non-significant reduction in the number of cigarettes smoked and nicotine dependence. MTQ and number of quit attempts all increased in the BSC group compared with usual care. There was no difference in terms of quality of life at any time point, but there was evidence of an increase in depression scores at 12 months for the BSC group. There were no serious adverse events thought likely to be related to the trial interventions. The pilot economic analysis demonstrated that it was feasible to carry out a full economic analysis.

Conclusions: It was possible to recruit people with SMI from primary and secondary care to a trial of a smoking cessation intervention based around behavioural support and medication. The overall direction of effect was a positive trend in relation to biochemically verified smoking cessation and it was feasible to obtain follow-up in a substantial proportion of participants. A definitive trial of a bespoke cessation intervention has been prioritised by the National Institute for Health Research (NIHR) and the SCIMITAR pilot trial forms a template for a fully powered RCT to examine clinical effectiveness and cost-effectiveness.

Trial Registration: Current Controlled Trials ISRCTN79497236.

Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment, Vol. 19, No. 25. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta19250DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4781066PMC
March 2015

Geophysical and Hydrologic Studies of Lake Seepage Variability.

Ground Water 2015 Nov-Dec;53(6):841-50. Epub 2014 Dec 31.

Department of Earth and Environmental Science, Temple University, Philadelphia, PA 19122.

Variations in lake seepage were studied along a 130 m shoreline of Mirror Lake NH. Seepage was downward from the lake to groundwater; rates measured from 28 seepage meters varied from 0 to -282 cm/d. Causes of this variation were investigated using electrical resistivity surveys and lakebed sediment characterization. Two-dimensional (2D) resistivity surveys showed a transition in lakebed sediments from outwash to till that correlated with high- and low-seepage zones, respectively. However, the 2D survey was not able to predict smaller scale variations within these facies. In the outwash, fast seepage was associated with permeability variations in a thin (2 cm) layer of sediments at the top of the lakebed. In the till, where seepage was slower than that in the outwash, a three-dimensional resistivity survey mapped a point of high seepage associated with heterogeneity (lower resistivity and likely higher permeability). Points of focused flow across the sediment-water interface are difficult to detect and can transmit a large percentage of total exchange. Using a series of electrical resistivity geophysical methods in combination with hydrologic data to locate heterogeneities that affect seepage rates can help guide seepage meter placement. Improving our understanding of the causes and types of heterogeneity in lake seepage will provide better data for lake budgets and prediction of mass transfer of solutes or contaminants between lakes and groundwater.
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http://dx.doi.org/10.1111/gwat.12309DOI Listing
July 2016

CASPER plus (CollAborative care in Screen-Positive EldeRs with major depressive disorder): study protocol for a randomised controlled trial.

Trials 2014 Nov 19;15:451. Epub 2014 Nov 19.

Department of Health Sciences, University of York, Seebohm Rowntree, Building, Heslington, York YO10 5DD, UK.

Background: Depression accounts for the greatest disease burden of all mental health disorders, contributes heavily to healthcare costs, and by 2020 is set to become the second largest cause of global disability. Although 10% to 16% of people aged 65 years and over are likely to experience depressive symptoms, the condition is under-diagnosed and often inadequately treated in primary care. Later-life depression is associated with chronic illness and disability, cognitive impairment and social isolation. With a progressively ageing population it becomes increasingly important to refine strategies to identity and manage depression in older people. Currently, management may be limited to the prescription of antidepressants where there may be poor concordance; older people may lack awareness of psychosocial interventions and general practitioners may neglect to offer this treatment option.

Methods/design: CASPER Plus is a multi-centre, randomised controlled trial of a collaborative care intervention for individuals aged 65 years and over experiencing moderate to severe depression. Selected practices in the North of England identify potentially eligible patients and invite them to participate in the study. A diagnostic interview is carried out and participants with major depressive disorder are randomised to either collaborative care or usual care. The recruitment target is 450 participants. The intervention, behavioural activation and medication management in a collaborative care framework, has been adapted to meet the complex needs of older people. It is delivered over eight to 10 weekly sessions by a case manager liaising with general practitioners. The trial aims to evaluate the clinical and cost effectiveness of collaborative care in addition to usual GP care versus usual GP care alone. The primary clinical outcome, depression severity, will be measured with the Patient Health Questionnaire-9 (PHQ-9) at baseline, 4, 12 and 18 months. Cost effectiveness analysis will assess health-related quality of life using the SF-12 and EQ-5D and will examine cost-consequences of collaborative care. A qualitative process evaluation will be undertaken to explore acceptability, gauge the extent to which the intervention is implemented and to explore sustainability beyond the clinical trial.

Discussion: Results will add to existing evidence and a positive outcome may lead to the commissioning of this model of service in primary care.

Trial Registration: ISRCTN45842879 (24 July 2012).
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http://dx.doi.org/10.1186/1745-6215-15-451DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4247639PMC
November 2014

Prior notification of trial participants by newsletter increased response rates: a randomized controlled trial.

J Clin Epidemiol 2012 Dec 15;65(12):1348-52. Epub 2012 Aug 15.

York Trials Unit, Department of Health Sciences, University of York, Heslington, YO10 5DD York, UK.

Objective: To assess the effectiveness of prenotification using a newsletter to increase questionnaire response rates within a randomized controlled trial (RCT).

Study Design And Setting: An RCT set within the context of the Medical Research Council's SCOOP trial of screening older women for fracture risk.

Results: A subsample of SCOOP participants were randomized in equal numbers to receive a newsletter approximately 6 weeks before the follow-up questionnaire or no newsletter. Of the 1,342 participants in the newsletter group, 1,291 (96.2%) returned their 24-month follow-up questionnaire compared with 1,271 of the 1,344 participants who were not allocated to receive the newsletter (94.6%). The difference of 1.6% was statistically significant (P=0.05), with an odds ratio (OR) of 1.45 (95% confidence interval [CI]: 1.01, 2.10). The newsletter and no newsletter groups required a similar number of reminders (OR 0.88, 95% CI: 0.73, 1.06), had a similar number with a complete primary outcome (OR 0.95, 95% CI: 0.57, 1.58), and took a similar time to respond (log rank 1.30, P=0.25).

Conclusions: This study supports previous research that suggests that prenotification increases survey response rate: albeit a small absolute increase. No previous study has shown this to be so within the context of patients enrolled within an RCT. Trials that use newsletters to keep their participants informed of the study's progress should use the newsletter as a prenotification device as this will increase overall response rates.
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http://dx.doi.org/10.1016/j.jclinepi.2012.05.008DOI Listing
December 2012

A randomised evaluation of CollAborative care and active surveillance for Screen-Positive EldeRs with sub-threshold depression (CASPER): study protocol for a randomized controlled trial.

Trials 2011 Oct 11;12:225. Epub 2011 Oct 11.

Department of Health Sciences, Seebohm Rowntree Building, University of York, Heslington, York, YO10 5DD, UK.

Background: Depression accounts for the greatest burden of disease among all mental health problems, and is expected to become the second-highest amongst all general health problems by 2020. By the age of 75, 1 in 7 older people meet formal diagnostic criteria for depression. Efforts to ameliorate the burden of illness and personal suffering associated with depression in older people have focussed on those with more severe depressive syndromes. Less attention has been paid to those with mild disorders/sub-threshold depressive syndromes but these patients also suffer impairments in their quality of life and level of functioning.

Methods/design: The CASPER study has been designed to assemble an epidemiological cohort of people over 75 years of age (the CASPER cohort), from which we will identify those eligible to participate in a trial of collaborative care for sub-threshold depression (the CASPER trial).We aim to undertake a pragmatic randomised controlled multi-centre trial evaluating the effectiveness and cost-effectiveness of collaborative care; a low intensity psychological intervention in addition to usual general practitioner care versus usual general practitioner care alone. General practitioners from practices based in the North of England will be asked to identify potentially eligible patients over the age of 75 years. Patients will be sent a letter inviting them to participate in the study.We aim to recruit approximately 540 participants for the CASPER trial. A diagnostic interview will be carried out to ascertain trial eligibility with the major depressive episode module of the Mini International Neuropsychiatric Interview (M.I.N.I.), eligible participants randomised to either the intervention or usual care. The primary outcome will be measured with the Patient Health Questionnaire-9 (PHQ-9) and additional quality of life measures will be collected. Data will be collected at baseline, 4 and 12 months for both trial and cohort participants.

Trial Registration: ISRCTN: ISRCTN02202951.
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http://dx.doi.org/10.1186/1745-6215-12-225DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3204244PMC
October 2011

Randomised controlled trial of food elimination diet based on IgG antibodies for the prevention of migraine like headaches.

Nutr J 2011 Aug 11;10:85. Epub 2011 Aug 11.

York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK.

Background: Research suggests that food intolerance may be a precipitating factor for migraine like headaches.

Aim: To evaluate the effectiveness of the ELISA (Enzyme Linked Immuno-Sorbent Assay) Test and subsequent dietary elimination advice for the prevention of migraine like headaches.

Design: Randomised controlled trial.

Setting: Community based volunteers in the UK.

Participants: Volunteers who met the inclusion criteria for migraine like headaches and had one or more food intolerance were included in the study. Participants received either a true diet (n = 84) or a sham diet (n = 83) sheet. Participants were advised to remove the intolerant foods from their diet for 12 weeks.

Main Outcome Measures: Number of headache days over a 12 week period (item A MIDAS questionnaire). Other measures includes the total MIDAS score and total HIT-6 score.

Results: The results indicated a small decrease in the number of migraine like headaches over 12 weeks, although this difference was not statistically significant (IRR 1.15 95% CI 0.94 to 1.41, p = 0.18). At the 4 week assessment, use of the ELISA test with subsequent diet elimination advice significantly reduced the number of migraine like headaches (IRR 1.23 95%CI 1.01 to 1.50, p = 0.04). The disability and impact on daily life of migraines were not significantly different between the true and sham diet groups.

Conclusions: Use of the ELISA test with subsequent diet elimination advice did not reduce the disability or impact on daily life of migraine like headaches or the number of migraine like headaches at 12 weeks but it did significantly reduce the number of migraine like headaches at 4 weeks.
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http://dx.doi.org/10.1186/1475-2891-10-85DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3199755PMC
August 2011

A controlled trial of envelope colour for increasing response rates in older women.

Aging Clin Exp Res 2011 Jun 1;23(3):236-40. Epub 2010 Sep 1.

York Trials Unit, Department of Health Sciences, University of York, Heslington, York, YO10 5DD, UK.

Background And Aims: Postal questionnaires are widely used in health research to provide measurable outcomes in areas such as quality of life. Participants who fail to return postal questionnaires can introduce non-response bias. Previous studies within populations over the age of 65 years have shown that response rates amongst older people can be 60% or less. The current study sought to investigate whether envelope colour affected response rates in a study about the effectiveness of screening older women for osteoporosis.

Methods: A total of 2803 eligible female participants aged between 70 and 85 were sent an invitation pack from their GP practice. The invitation was either in a brown or white envelope and contained a matching pre-paid reply envelope. A study questionnaire was also sent out in brown or white envelopes 1 week after consenting to participate in the trial.

Results: The overall response rate was 78%. There was little evidence of an effect of envelope colour on response to the invitation to participate in the trial (OR 1.04, 95% CI 0.87-1.24). Similarly, there was no influence of envelope colour on the number of participants returning their questionnaires (OR 0.99, 95% CI 0.60-1.63). There was weak evidence of an effect of envelope colour on the response rates of the consent process (OR 0.86, 95% CI 0.74-1.00). When we updated a recent meta-analysis with the results of this study, there was a non-statistically- significant trend for greater response rates with brown envelopes compared with white envelopes (OR 1.19, 95% CI 0.86-1.64, I2=92%). However, the results where influenced by one study and when this study was excluded the pooled estimate was 0.98 (95% CI 0.89-1.08, I2=0%).

Conclusion: This study found no evidence to suggest envelope colour has an effect on response to participate in a trial or questionnaire returns. There is weak evidence to suggest envelope colour may affect consent into a trial.
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http://dx.doi.org/10.1007/BF03337749DOI Listing
June 2011

A randomized trial of electronic reminders showed a reduction in the time to respond to postal questionnaires.

J Clin Epidemiol 2011 Feb 15;64(2):208-12. Epub 2010 Jun 15.

Department of Health Sciences, York Trials Unit, Area 4, Seebohm Rowntree Building, The University of York, Heslington, York YO10 5DD, UK.

Objective: To assess the effect of electronic reminders (ERs) on response rate and time to response for the return of postal questionnaires.

Study Design And Setting: This open randomized controlled trial (RCT) was conducted at the University of York. Participants who were taking part in an established RCT and who provided an electronic mail address and/or mobile telephone number were eligible to take part in the study. The intervention group received ERs on the day they were expected to receive postal questionnaires.

Results: One hundred forty-eight participants (19 male and 129 female) aged 47±11 (range, 19-65) years were studied. About 89.2% of participants returned postal questionnaires. There was no difference in questionnaire response rates in control (64 of 74 [86.5%]) vs. intervention (68 of 74 [91.9%]), groups (relative risk=1.063, 95% confidence interval: 0.949-1.189). Median questionnaire time to response was 4 days less in the intervention group (10.0±0.2; range, 10-14 days) compared with the control group (14.0±1.4; range, 10-23 days) (χ(2)(1df)=5.27, P=0.022).

Conclusion: ERs are useful tools for reducing participant time to response for postal questionnaires. We found little evidence for an effect of ERs on response rate for postal questionnaires.
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http://dx.doi.org/10.1016/j.jclinepi.2010.01.020DOI Listing
February 2011

A national survey of computerized decision support systems available to nurses in England.

J Nurs Manag 2009 Nov;17(7):772-80

Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK.

Aim: To examine the characteristics of computerized decision support systems (CDSS) currently available to nurses working in the National Health Service (NHS) in England.

Method: A questionnaire survey sent to a stratified random sample of 50% of all NHS care providers (Trusts) in England, asking respondents to provide information on CDSS currently used by nurses.

Results: Responses were received from 108 of the 277 Trusts included in the sample. Electronic patient record systems were the most common type of CDSS reported by Trusts (n = 61) but they were least likely to have features that have been associated with improved clinical outcomes.

Conclusions: The availability of CDSS with features that have been associated with improved patient outcomes for nurses in the NHS in England is limited. There is some evidence that the nature of the Trust affects whether or not nurses have access to CDSS to assist their decision making.

Implications For Nursing Management: The implementation of CDSS is increasing throughout the NHS. Many CDSS are introduced without adequate evidence to support its introduction and there is little evaluation of the benefits once they are implemented. Policy makers and nursing management should consider whether the introduction of CDSS aids nurse decision making and benefits patient outcomes.
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http://dx.doi.org/10.1111/j.1365-2834.2009.00986.xDOI Listing
November 2009
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