Patient-reported outcome measures for monitoring primary care patients with depression: the PROMDEP cluster RCT and economic evaluation.

Background: Guidelines on the management of depression recommend that practitioners use patient-reported outcome measures for the follow-up monitoring of symptoms, but there is a lack of evidence of benefit in terms of patient outcomes. Objective: To test using the Patient Health Questionnaire-9 questionnaire as a patient-reported outcome measure for monitoring depression, training practitioners in interpreting scores and giving patients feedback. Design: Parallel-group, cluster-randomised superiority trial; 1 : 1 allocation to intervention and control. Setting: UK primary care (141 group general practices in England and Wales). Inclusion criteria: Patients aged ≥ 18 years with a new episode of depressive disorder or symptoms, recruited mainly through medical record searches, plus opportunistically in consultations. Exclusions: Current depression treatment, dementia, psychosis, substance misuse and risk of suicide. Intervention: Administration of the Patient Health Questionnaire-9 questionnaire with patient feedback soon after diagnosis, and at follow-up 10-35 days later, compared with usual care. Primary outcome: Beck Depression Inventory, 2nd edition, symptom scores at 12 weeks. Secondary outcomes: Beck Depression Inventory, 2nd edition, scores at 26 weeks; antidepressant drug treatment and mental health service contacts; social functioning (Work and Social Adjustment Scale) and quality of life (EuroQol 5-Dimension, five-level) at 12 and 26 weeks; service use over 26 weeks to calculate NHS costs; patient satisfaction at 26 weeks (Medical Informant Satisfaction Scale); and adverse events. Sample size: The original target sample of 676 patients recruited was reduced to 554 due to finding a significant correlation between baseline and follow-up values for the primary outcome measure. Randomisation: Remote computerised randomisation with minimisation by recruiting university, small/large practice and urban/rural location. Blinding: Blinding of participants was impossible given the open cluster design, but self-report outcome measures prevented observer bias. Analysis was blind to allocation. Analysis: Linear mixed models were used, adjusted for baseline depression, baseline anxiety, sociodemographic factors, and clustering including practice as random effect. Quality of life and costs were analysed over 26 weeks. Qualitative interviews: Practitioner and patient interviews were conducted to reflect on trial processes and use of the Patient Health Questionnaire-9 using the Normalization Process Theory framework. Results: Three hundred and two patients were recruited in intervention arm practices and 227 patients were recruited in control practices. Primary outcome data were collected for 252 (83.4%) and 195 (85.9%), respectively. No significant difference in Beck Depression Inventory, 2nd edition, score was found at 12 weeks (adjusted mean difference -0.46, 95% confidence interval -2.16 to 1.26). Nor were significant differences found in Beck Depression Inventory, 2nd Edition, score at 26 weeks, social functioning, patient satisfaction or adverse events. EuroQol-5 Dimensions, five-level version, quality-of-life scores favoured the intervention arm at 26 weeks (adjusted mean difference 0.053, 95% confidence interval 0.013 to 0.093). However, quality-adjusted life-years over 26 weeks were not significantly greater (difference 0.0013, 95% confidence interval -0.0157 to 0.0182). Costs were lower in the intervention arm but, again, not significantly (-£163, 95% confidence interval -£349 to £28). Cost-effectiveness and cost-utility analyses, therefore, suggested that the intervention was dominant over usual care, but with considerable uncertainty around the point estimates. Patients valued using the Patient Health Questionnaire-9 to compare scores at baseline and follow-up, whereas practitioner views were more mixed, with some considering it too time-consuming. Conclusions: We found no evidence of improved depression management or outcome at 12 weeks from using the Patient Health Questionnaire-9, but patients' quality of life was better at 26 weeks, perhaps because feedback of Patient Health Questionnaire-9 scores increased their awareness of improvement in their depression and reduced their anxiety. Further research in primary care should evaluate patient-reported outcome measures including anxiety symptoms, administered remotely, with algorithms delivering clear recommendations for changes in treatment. Study registration: This study is registered as IRAS250225 and ISRCTN17299295. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/42/02) and is published in full in Health Technology Assessment; Vol. 28, No. 17. See the NIHR Funding and Awards website for further award information.

Depression is common, can be disabling and costs the nation billions. The National Health Service recommends general practitioners who treat people with depression use symptom questionnaires to help assess whether those people are getting better over time. A symptom questionnaire is one type of patient-reported outcome measure. Patient-reported outcome measures appear to benefit people having therapy and mental health care, but this approach has not been tested thoroughly in general practice. Most people with depression are treated in general practice, so it is important to test patient-reported outcome measures there, too. In this study, we tested whether using a patient-reported outcome measure helps people with depression get better more quickly. The study was a 'randomised controlled trial' in general practices, split into two groups. In one group, people with depression completed the Patient Health Questionnaire, or 'PHQ-9', patient-reported outcome measure, which measures nine symptoms of depression. In the other group, people with depression were treated as usual without the Patient Health Questionnaire-9. We fed the results of the Patient Health Questionnaire-9 back to the people with depression themselves to show them how severe their depression was and asked them to discuss the results with the practitioners looking after them. We found no differences between the patient-reported outcome measure group and the control group in their level of depression; their work or social life; their satisfaction with care from their practice; or their use of medicines, therapy or specialist care for depression. However, we did find that their quality of life was improved at 6 months, and the costs of the National Health Service services they used were lower. Using the Patient Health Questionnaire-9 can improve patients' quality of life, perhaps by making them more aware of improvement in their depression symptoms, and less anxious as a result. Future research should test using a patient-reported outcome measure that includes anxiety and processing the answers through a computer to give practitioners clearer advice on possible changes to treatment for depression.

Depression follow-up monitoring with the PHQ-9: open cluster-randomised controlled trial.

BACKGROUND: Outcome monitoring of depression is recommended but lacks evidence of patient benefit in primary care. AIM: To test monitoring depression using the PHQ-9 questionnaire with patient feedback. DESIGN AND SETTING: Open cluster-randomised controlled trial in 141 group practices. METHOD: Adults with new depressive episodes were recruited through records searches and opportunistically. EXCLUSION CRITERIA: dementia, psychosis, substance misuse, suicide risk. The PHQ-9 questionnaire was to be administered soon after diagnosis, and 10-35 days later. PRIMARY OUTCOME: Beck Depression Inventory (BDI-II) score at 12 weeks. SECONDARY OUTCOMES: BDI-II at 26 weeks; Work and Social Adjustment Scale and EuroQol EQ-5D-5L quality of life at 12 and 26 weeks; antidepressant treatment, mental health service use, adverse events, and Medical Informant Satisfaction Scale over 26 weeks. RESULTS: 302 intervention arm patients were recruited and 227 controls. At 12 weeks 252 (83.4%) and 195 (85.9%) were followed-up respectively. Only 41% of intervention arm patients had a GP follow-up PHQ-9 recorded. There was no significant difference in BDI-II score at 12 weeks (mean difference -0.46; 95% CI -2.16,1.26), adjusted for baseline depression, baseline anxiety, sociodemographic factors, and clustering by practice). EQ-5D-5L quality of life scores were higher in the intervention arm at 26 weeks (adjusted mean difference 0.053; 95% CI 0.093,0.013). A clinically significant difference in depression at 26 weeks could not be ruled out. No significant differences were found in social functioning, adverse events, or satisfaction. In a per-protocol analysis, antidepressant use and mental health contacts were significantly greater in intervention arm patients with a recorded follow-up PHQ-9. CONCLUSIONS: No evidence was found of improved depression outcome at 12 weeks from monitoring. The findings of possible benefits over 26 weeks warrant replication, investigating possible mechanisms, preferably with automated delivery of monitoring and more instructive feedback.

Placing the suspect at a PC: A preliminary study involving fingerprints on keyboards and mice.

Digital devices now play an important role in the lives of many in society. Whilst they are used predominantly for legitimate purposes, instances of digital crime are witnessed, where determining their usage is important to any criminal investigation. Typically, when determining who has used a digital device, digital forensic analysis is utilised, however, biological trace evidence or fingerprints residing on its surfaces may also be of value. This work provides a preliminary study which examines the potential for fingerprint recovery from computer peripherals, namely keyboards and mice. Our implementation methodology is outlined, and results discussed which indicate that print recovery is possible. Findings are intended to support those operating at-scene in an evidence collection capacity.

A review of quality procedures in the UK forensic sciences: What can the field of digital forensics learn?

With a reliance on the various forms of forensic science evidence in complex criminal investigations, the measures for ensuring its quality are facing increasing scrutiny. Improvements to quality management systems, to ensure both the robust application of scientific principles and the accurate interpretation and reporting of results, have arisen as a consequence of high-profile rebuttals of forensic science evidence, combined with process improvements driven by evaluation of current practice. These improvements are crucial to ensure validity of results as well as providing assurance for all those involved in the Criminal Justice System. This work first examines the quality management systems utilised for the examination and analysis of fingerprint, body fluid and DNA evidence. It then proceeds to highlight an apparent lack of comparable quality assurance mechanisms within the field of digital forensics, one of the newest branches of forensic science. Proposals are provided for the improvement of quality assurance for the digital forensics arena, drawing on the experiences of, and more well-established practices within, other forensic disciplines.

The NHS Health Check programme: implementation in east London 2009-2011.

OBJECTIVES: To describe implementation and results from the National Health Service (NHS) Health Check programme. DESIGN: Three-year observational open cohort study: 2009-2011. PARTICIPANTS: People of age 40-74 years eligible for an NHS Health Check. SETTING: 139/143 general practices in three east London primary care trusts (PCTs) serving an ethnically diverse and socially disadvantaged population. METHOD: Implementation was supported with education, IT support and performance reports. Tower Hamlets PCT additionally used managed practice networks and prior-stratification to call people at higher cardiovascular (CVD) risk first. MAIN OUTCOMES MEASURES: Attendance, proportion of high-risk population on statins and comorbidities identified. RESULTS: Coverage 2009, 2010, 2011 was 33.9% (31,878/10,805), 60.6% (30,757/18,652) and 73.4% (21,194/28,890), respectively. Older people were more likely to attend than younger people. Attendance was similar across deprivation quintiles and was in accordance with population distributions of black African/Caribbean, South Asian and White ethnic groups. 1 in 10 attendees were at high-CVD risk (20% or more 10-year risk). In the two PCTs stratifying risk, 14.3% and 9.4% of attendees were at high-CVD risk compared to 8.6% in the PCT using an unselected invitation strategy. Statin prescription to people at high-CVD risk was higher in Tower Hamlets 48.9%, than in City and Hackney 23.1% or Newham 20.2%. In the 6 months following an NHS Health Check, 1349 new cases of hypertension, 638 new cases of diabetes and 89 new cases of chronic kidney disease (CKD) were diagnosed. This represents 1 new case of hypertension per 38 Checks, 1 new case of diabetes per 80 Checks and 1 new case of CKD per 568 Checks. CONCLUSIONS: Implementation of the NHS Health Check programme in these localities demonstrates limited success. Coverage and treatment of those at high-CVD risk could be improved. Targeting invitations to people at high-CVD risk and managed practice networks in Tower Hamlets improved performance.

Transferring knowledge about human subjects protections and the role of institutional review boards in a community-based participatory research project.

Among the first tasks in a collaboration between Tufts University and community organizations in Somerville, MA, was designing an interview instrument to assess occupational health needs among immigrant workers. Human subjects protections was a critical issue, but community partners were not well informed about the need for such protections or the role of the institutional review board (IRB). During research meetings, members of the team from Tufts trained community collaborators to work with research participants and organized a presentation by a key university IRB administrator. We present findings from the process evaluation of this project and suggest ways to (1) assess community partners' understanding about working with research volunteers, (2) train collaborators, and (3) involve IRBs.

Phosphoramidate derivatives of hydroxysteroids as inhibitors of prostate-specific membrane antigen.

Prostate-specific membrane antigen (PSMA) is a membrane-bound cell surface peptidase which is over-expressed in prostate cancer cells. The enzymatic activities of PSMA are understood but the role of the enzyme in prostate cancer remains conjectural. We previously confirmed the existence of a hydrophobic binding site remote from the enzyme's catalytic center. To explore the specificity and accommodation of this binding site, we prepared a series of six glutamate-containing phosphoramidate derivatives of various hydroxysteroids (1a-1f). The inhibitory potencies of the individual compounds of the series were comparable to a simple phenylalkyl analog (8), and in all cases IC50 values were sub-micromolar. Molecular docking was used to develop a binding model for these inhibitors and to understand their relative inhibitory potencies against PSMA.

Negative life events, social support and gender difference in depression: a multinational community survey with data from the ODIN study.

OBJECTIVE: To explore if differences in negative life events, vulnerability and social support may explain the gender difference in depression. METHODS: Cross-sectional, multinational, community survey from five European countries (n = 8,787). Depression is measured by Beck Depression Inventory, whereas negative life events and social support are measured by various questionnaires. RESULTS: Women report slightly more negative life events than men do, mainly related to the social network, but more social support in general and in connection with reported life events. This trend is the same in all participating countries except Spain, where there is no gender difference in the reported support. In general, women are not more vulnerable to negative life events than men are. However, women with no social support, who are exposed to life events, are more vulnerable than men without support. CONCLUSION: The higher rate of depression in women is not explained by gender differences in negative life events, social support or vulnerability.

Personality disorder, depression and functioning: results from the ODIN study.

BACKGROUND: There is little information of the prevalence of personality disorder (PD) in those with depressive disorder in community samples; neither is there any data on the impact of PD on service utilisation or outcome in this setting. METHODS: A two stage screening study to identify cases of depressive disorder using SCAN in five European countries. Personality assessed 6 months after the diagnostic interview. Follow-up for 1 year using symptom and social function measures. RESULTS: Personality disorder is present in 22% of a community sample with depressive disorders but the range varied from 13.7% to 33.3% across countries. Cluster C formed 43% of the total. Long-term psychotropic drug use was more common in the PD group even after depression was controlled. Those with PD had higher symptom scores at the outset and, although the PD group was more likely to be cases at follow-up, this disappeared when the depression score was co-varied. Only initial social function predicted outcome at 6 and 12 months. LIMITATIONS: The use of a non-treatment seeking population may limit the application of the findings to clinical populations. CONCLUSIONS: PD is common even in a non-treatment seeking population with depressive disorder. It impacts upon outcome at 6 and 12 months but this is related to the initial severity of depressed mood. Social function is the only independent predictor of outcome and should be assessed separately.