Using evidence to improve Psychological Therapies Services

Psychological therapy services offer help to clients with many different sorts of mental health problems using a variety of therapies provided by a range of different professional groups and are supported by a large amount of research evidence. However, applying evidence-based practice in routine clinical settings presents particular challenges. This paper outlines some of the difficulties applying research findings to routine settings and argues for a more inclusive approach to linking evidence with practice. It describes a systematic approach to service evaluation and practice based evidence within a large psychological therapies service. This approach is integrated into the service delivery. It enables clinicians to become engaged in the process of reflecting on evidence in a non-threatening way and allows innovative ways of enhancing reflective practice by linking evidence with practice in routine settings

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

Background A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. Methods This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. Findings Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. Interpretation ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK.

BACKGROUND: A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. METHODS: This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. FINDINGS: Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0-75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4-97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8-80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3-4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. INTERPRETATION: ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials. FUNDING: UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D'Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca

Evaluating psychological therapies services: A review of outcome measures and their utility

We describe the use of a number of outcome measures that have been used over the past eight years to evaluate adult psychological therapies services in the Wakefield & Pontefract locality of the South West Yorkshire Mental Health NHS Trust. The psychological therapies service now has a unique database of outcome measures completed by 5563 clients, which has been used nationally and internationally for service evaluation and research purposes. Internally, the database has informed the clinical service, allowing prioritising of referrals and feedback to clinicians and referral agencies on the quality of the service and appropriateness of referrals. We describe the properties and intended use of the measures, the way results are fed back to the service and evaluate the usefulness of the measures in routine service settings. Implications for psychological therapies and other mental health services are discussed including: • Choice of generic or specific outcome measures • How the measures relate to one another • Clinical usefulness of the measures, including risk assessment • Interpretation of results, including availability of norms and how to assess change • Practical utility, including cos

Early sudden gains in psychotherapy under routine clinic conditions: Practice-based evidence.

Sudden gains---large, enduring reductions in symptom intensity from one session to the next--were identified by T. Z. Tang and R. J. DeRubeis (1999) on the basis of data from 2 manualized clinical trials of cognitive therapy for depression. The authors found similar sudden gains among clients with a variety of disorders treated with a variety of approaches in routine clinic settings. Clients (N=135 who met inclusion criteria) completed short forms of the Clinical Outcomes in Routine Evaluation (CORE-SF) preceding 7 to 74 individual sessions. Those who experienced sudden gains within their first 16 sessions (n=23) had significantly lower CORE-SF scores in their final 3 sessions than did the other clients

Assessing risk and emotional disturbance using the CORE-OM and HoNOS outcome measures at the interface between primary and secondary mental healthcare

AIMS AND METHOD There is interest in how outcome measures routinely used in mental health settings compare with each other in assessing risk and emotional disturbance. The relation between the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM), a client-completed measure, and the Health of the Nation Outcome Scale (HoNOS), a clinician-completed measure, was explored using data from 297 clients referred to secondary services by a primary care mental health liaison team. RESULTS The correlation between CORE-OM and HoNOS was 0.50, with cluster and factor analyses revealing overlap between the measures in assessing risk to self and others and general emotional issues. CLINICAL IMPLICATIONS Although the measures are typically used in different settings, the overlap suggests that both might be useful in any setting where assessment for mental health problems and risk is neede

Predicting change for individual psychotherapy clients based on their nearest neighbors

This study extended client-focused research by using the nearest neighbor (NN) approach, a client-specific sampling and prediction strategy derived from research on alpine avalanches. Psychotherapy clients (N = 203) seen in routine practice settings in the United Kingdom completed a battery of intake measures and then completed symptom intensity ratings before each session. Forecasts of each client's rate of change and session-by-session variability were computed on the basis of that client's NNs (n = 10-50 in different comparisons). Alternative forecasts used linear or log-linear slopes and were compared with an alternative prediction strategy. Results showed that the NN approach was superior to the alternative model in predicting rate of change, though the advantage was less clear for predicting variability. (PsycINFO Database Record (c) 2009 APA, all rights reserved

Therapists' recall of early sudden gains in routine clinical practice

This study followed up one by Stiles et al. (2003), which identified sudden gains – large reductions from one session to the next on a short form of clinical outcomes in routine evaluation outcome measure (CORE-SF) – by some clients in routine clinical practice. We interviewed the therapists who had treated sudden gain and non-sudden gain clients. Results showed that therapists could retrospectively identify which clients had or had not experienced sudden CORE-SF gains at substantially better than chance rates, although they identified only about half of the clients who had experienced such gains

Transforming between Beck Depression Inventory and CORE-OM scores in routine clinical practice

Abstract: Objectives. The Clinical Outcomes in Routine Evaluation – Outcome Measure (CORE-OM) and the Beck Depression Inventory (BDI) are routinely used to assess emotional problems. It would be helpful to be able to compare scores when only one of the measures is available. We investigated the relationship between the measures and produced translation tables. Methods. Level of agreement between CORE-OM and BDI-I was assessed for 2,234 clients who had completed both measures at referral for routine secondary care. Tables for predicting between the measures were constructed using several methods, including non-linear regression and non-parametric smoothing. Results were cross-validated on a separate sample of 326 clients. Results. High correlations between the measures were obtained (r=.862 for female clients; r=.855 for male clients). Accuracy in predicting caseness is higher than predicting depression levels. Conclusions. CORE-OM and BDI can be compared in routine clinical settings with acceptable accuracy