Francesca Pesola

Supporting recovery in patients with psychosis through care by community-based adult mental health teams (REFOCUS): a multisite, cluster, randomised, controlled trial

BACKGROUND Mental health policy in many countries is oriented around recovery, but the evidence base for service-level recovery-promotion interventions is lacking. METHODS We did a cluster, randomised, controlled trial in two National Health Service Trusts in England. REFOCUS is a 1-year team-level intervention targeting staff behaviour to increase focus on values, preferences, strengths, and goals of patients with psychosis, and staff-patient relationships, through coaching and partnership. Between April, 2011, and May, 2012, community-based adult mental health teams were randomly allocated to provide usual treatment plus REFOCUS or usual treatment alone (control). Baseline and 1-year follow-up outcomes were assessed in randomly selected patients. The primary outcome was recovery and was assessed with the Questionnaire about Processes of Recovery (QPR). We also calculated overall service costs. We used multiple imputation to estimate missing data, and the imputation model captured clustering at the team level. Analysis was by intention to treat. This trial is registered, number ISRCTN02507940. FINDINGS 14 teams were included in the REFOCUS group and 13 in the control group. Outcomes were assessed in 403 patients (88% of the target sample) at baseline and in 297 at 1 year. Mean QPR total scores did not differ between the two groups (REFOCUS group 40·6 [SD 10·1] vs control 40·0 [10·2], adjusted difference 0·68, 95% CI -1·7 to 3·1, p=0·58). High team participation was associated with higher staff-rated scores for recovery-promotion behaviour change (adjusted difference -0·4, 95% CI -0·7 to -0·2, p=0·001) and patient-rated QPR interpersonal scores (-1·6, -2·7 to -0·5, p=0·005) at follow-up than low participation. Patients treated in the REFOCUS group incurred £1062 (95% CI -1103 to 3017) lower adjusted costs than those in the control group. INTERPRETATION Although the primary endpoint was negative, supporting recovery might, from the staff perspective, improve functioning and reduce needs. Implementation of REFOCUS could increase staff recovery-promotion behaviours and improve patient-rated recovery. FUNDING National Institute for Health Research.

Impact of cervical screening on cervical cancer mortality: estimation using stage-specific results from a nested case-control study

Background:It is well established that screening can prevent cervical cancer, but the magnitude of the impact of regular screening on cervical cancer mortality is unknown.Methods:Population-based case–control study using prospectively recorded cervical screening data, England 1988–2013. Case women had cervical cancer diagnosed during April 2007–March 2013 aged 25–79 years (N=11 619). Two cancer-free controls were individually age matched to each case. We used conditional logistic regression to estimate the odds ratio (OR) of developing stage-specific cancer for women regularly screened or irregularly screened compared with women not screened in the preceding 15 years. Mortality was estimated from excess deaths within 5 years of diagnosis using stage-specific 5-year relative survival from England with adjustment for age within stage based on SEER (Surveillance, Epidemiology and End Results, USA) data.Results:In women aged 35–64 years, regular screening is associated with a 67% (95% confidence interval (CI): 62–73%) reduction in stage 1A cancer and a 95% (95% CI: 94–97%) reduction in stage 3 or worse cervical cancer: the estimated OR comparing regular (⩽5.5yearly) screening to no (or minimal) screening are 0.18 (95% CI: 0.16–0.19) for cancer incidence and 0.08 (95% CI: 0.07–0.09) for mortality. It is estimated that in England screening currently prevents 70% (95% CI: 66–73%) of cervical cancer deaths (all ages); however, if everyone attended screening regularly, 83% (95% CI: 82–84%) could be prevented.Conclusions:The association between cervical cancer screening and incidence is stronger in more advanced stage cancers, and screening is more effective at preventing death from cancer than preventing cancer itself.

Evaluation of a positive psychotherapy group intervention for people with psychosis: pilot randomised controlled trial.

AIMS Third-wave psychological interventions have gained relevance in mental health service provision but their application to people with psychosis is in its infancy and interventions targeting wellbeing in psychosis are scarce. This study tested the feasibility and preliminary effectiveness of positive psychotherapy adapted for people with psychosis (WELLFOCUS PPT) to improve wellbeing. METHODS WELLFOCUS PPT was tested as an 11-week group intervention in a convenience sample of people with psychosis in a single centre randomised controlled trial (ISRCTN04199273) involving 94 people with psychosis. Patients were individually randomised in blocks to receive either WELLFOCUS PPT in addition to treatment as usual (TAU), or TAU only. Assessments took place before randomisation and after the therapy. The primary outcome was wellbeing (Warwick-Edinburgh Mental Well-Being Scale, WEMWBS). Secondary outcomes included symptoms (Brief Psychiatric Rating Scale), depression (Short Depression-Happiness Scale), self-esteem, empowerment, hope, sense of coherence, savouring beliefs and functioning, as well as two alternative measures of wellbeing (the Positive Psychotherapy Inventory and Quality of Life). Intention-to-treat analysis was performed. This involved calculating crude changes and paired-sample t-tests for all variables, as well as ANCOVA and Complier Average Causal Effect (CACE) Analysis to estimate the main effect of group on all outcomes. RESULTS The intervention and trial procedures proved feasible and well accepted. Crude changes between baseline and follow-up showed a significant improvement in the intervention group for wellbeing according to all three concepts assessed (i.e., WEMWBS, Positive Psychotherapy Inventory and Quality of Life), as well as for symptoms, depression, hope, self-esteem and sense of coherence. No significant changes were observed in the control group. ANCOVA showed no main effect on wellbeing according to the primary outcome scale (WEMWBS) but significant effects on symptoms (p = 0.006, ES = 0.42), depression (p = 0.03, ES = 0.38) and wellbeing according to the Positive Psychotherapy Inventory (p = 0.02, ES = 0.30). Secondary analysis adapting for therapy group further improved the results for symptom reduction (p = 0.004, ES = 0.43) and depression (p = 0.03, ES = 0.41) but did not lead to any more outcomes falling below the p = 0.05 significance level. CACE analysis showed a non-significant positive association between the intervention and WEMWBS scores at follow-up (b = 0.21, z = 0.9, p = 0.4). CONCLUSIONS This study provides initial evidence on the feasibility of WELLFOCUS PPT in people with psychosis, positively affecting symptoms and depression. However, more work is needed to optimise its effectiveness. Future research might evaluate positive psychotherapy as a treatment for comorbid depression in psychosis, and consider alternative measurements of wellbeing.

Sexual orientation and alcohol problem use among UK adolescents: an indirect link through depressed mood

BACKGROUND AND AIMS Sexual minority adolescents are more likely to engage in alcohol use than their heterosexual counterparts; however, the underlying reasons remain unclear and longitudinal research is limited. Owing to evidence that this group also experiences greater depressive symptoms than their peers, we aimed to (i) assess to what extent depressed mood explains the increased likelihood of engaging in alcohol use among sexual minority adolescents, and (ii) explore potential gender-specific patterns. DESIGN Structural equation modelling was used to test the indirect relationship between sexual orientation and alcohol use through depressed mood, with heterosexuals as the reference group. SETTINGS AND PARTICIPANTS A total of 3710 adolescents (12% sexual minority), from the Avon Longitudinal Study of Parents and Children (ALSPAC) study, assessed between the ages of 15 and 18 years. MEASUREMENTS Sexual orientation was assessed at age 15, while alcohol use was measured using the Alcohol Use Disorders Identification Test (AUDIT) at age 18. Depressed mood was indexed by the Short Mood and Feelings Questionnaire (SMFQ) at age 16. FINDINGS Sexual minority adolescents were more likely to engage in alcohol problem use compared to their heterosexual counterparts [Btotal  = 0.12, 95% confidence interval (CI) = 0.04-0.20, P = 0.003]. Depressed mood explained 21% of the link between sexual orientation and alcohol use after adjustment for covariates and earlier measures (Z = 3.2, P = 0.001). No gender differences were observed. CONCLUSIONS A higher prevalence of alcohol problem use in adolescents who are gay, lesbian or bisexual is partly explained by increased rates of depression in this group.

The relationship between clinical and recovery dimensions of outcome in mental health

BACKGROUND Little is known about the empirical relationship between clinical and personal recovery. AIMS To examine whether there are separate constructs of clinical recovery and personal recovery dimensions of outcome, how they change over time and how they can be assessed. METHOD Standardised outcome measures were administered at baseline and one-year follow-up to participants in the REFOCUS Trial (ISRCTN02507940). An exploratory factor analysis was conducted and a confirmatory factor analysis assessed change across time. RESULTS We identified three factors: patient-rated personal recovery, patient-rated clinical recovery and staff-rated clinical recovery. Only the personal recovery factor improved after one year. HHI, CANSAS-P and HoNOS were the best measures for research and practice. CONCLUSIONS The identification of three rather than two factors was unexpected. Our findings support the value of concurrently assessing staff and patient perceptions of outcome. Only the personal recovery factor changed over time, this desynchrony between clinical and recovery outcomes providing empirical evidence that clinical recovery and personal recovery are not the same. We did not find evidence of a trade-off between clinical recovery and personal recovery outcomes. Optimal assessment based on our data would involve assessment of hope, social disability and patient-rated unmet need.

Guided graded exercise self-help plus specialist medical care versus specialist medical care alone for chronic fatigue syndrome (GETSET): a pragmatic randomised controlled trial

Summary Background Graded exercise therapy is an effective and safe treatment for chronic fatigue syndrome, but it is therapist intensive and availability is limited. We aimed to test the efficacy and safety of graded exercise delivered as guided self-help. Methods In this pragmatic randomised controlled trial, we recruited adult patients (18 years and older) who met the UK National Institute for Health and Care Excellence criteria for chronic fatigue syndrome from two secondary-care clinics in the UK. Patients were randomly assigned to receive specialist medical care (SMC) alone (control group) or SMC with additional guided graded exercise self-help (GES). Block randomisation (randomly varying block sizes) was done at the level of the individual with a computer-generated sequence and was stratified by centre, depression score, and severity of physical disability. Patients and physiotherapists were necessarily unmasked from intervention assignment; the statistician was masked from intervention assignment. SMC was delivered by specialist doctors but was not standardised; GES consisted of a self-help booklet describing a six-step graded exercise programme that would take roughly 12 weeks to complete, and up to four guidance sessions with a physiotherapist over 8 weeks (maximum 90 min in total). Primary outcomes were fatigue (measured by the Chalder Fatigue Questionnaire) and physical function (assessed by the Short Form-36 physical function subscale); both were self-rated by patients at 12 weeks after randomisation and analysed in all randomised patients with outcome data at follow-up (ie, by modified intention to treat). We recorded adverse events, including serious adverse reactions to trial interventions. We used multiple linear regression analysis to compare SMC with GES, adjusting for baseline and stratification factors. This trial is registered at ISRCTN, number ISRCTN22975026. Findings Between May 15, 2012, and Dec 24, 2014, we recruited 211 eligible patients, of whom 107 were assigned to the GES group and 104 to the control group. At 12 weeks, compared with the control group, mean fatigue score was 19·1 (SD 7·6) in the GES group and 22·9 (6·9) in the control group (adjusted difference −4·2 points, 95% CI −6·1 to −2·3, p<0·0001; effect size 0·53) and mean physical function score was 55·7 (23·3) in the GES group and 50·8 (25·3) in the control group (adjusted difference 6·3 points, 1·8 to 10·8, p=0·006; 0·20). No serious adverse reactions were recorded and other safety measures did not differ between the groups, after allowing for missing data. Interpretation GES is a safe intervention that might reduce fatigue and, to a lesser extent, physical disability for patients with chronic fatigue syndrome. These findings need confirmation and extension to other health-care settings. Funding UK National Institute for Health Research Research for Patient Benefit Programme and the Sue Estermann Fund.

Psychometric evaluation of the Questionnaire about the Process of Recovery (QPR)

BACKGROUND Supporting recovery is the aim of national mental health policy in many countries. However, only one measure of recovery has been developed in England: the Questionnaire about the Process of Recovery (QPR), which measures recovery from the perspective of adult mental health service users with a psychosis diagnosis. AIMS To independently evaluate the psychometric properties of the 15- and 22-item versions of the QPR. METHOD Two samples were used: data-set 1 (n = 88) involved assessment of the QPR at baseline, 2 weeks and 3 months. Data-set 2 (n = 399; trial registration: ISRCTN02507940) involved assessment of the QPR at baseline and 1 year. RESULTS For the 15-item version, internal consistency was 0.89, convergent validity was 0.73, test-retest reliability was 0.74 and sensitivity to change was 0.40. Confirmatory factor analysis showed the 15-item version offered a good fit. For the 22-item version, the interpersonal subscale was found to underperform and the intrapersonal subscale overlaps substantially with the 15-item version. CONCLUSIONS Both the 15-item and the intrapersonal subscale of the 22-item versions of the QPR demonstrated satisfactory psychometric properties. The 15-item version is slightly more robust and also less burdensome, so it can be recommended for use in research and clinical practice.

Effects of Clinical Decision Topic on Patients’ Involvement in and Satisfaction With Decisions and Their Subsequent Implementation

OBJECTIVE Clinical decision making is an important aspect of mental health care. Predictors of how patients experience decision making and whether decisions are implemented are underresearched. This study investigated the relationship between decision topic and involvement in the decision, satisfaction with it, and its subsequent implementation from both staff and patient perspectives. METHODS As part of the Clinical Decision Making and Outcome in Routine Care for People With Severe Mental Illness study, patients (N=588) and their providers (N=213) were recruited from community-based mental health services in six European countries. Both completed bimonthly assessments for one year using the Clinical Decision Making in Routine Care Scale to assess the decision topic and implementation; both also completed the Clinical Decision Making Involvement and Satisfaction Scale. RESULTS Three categories of decision topics were determined: treatment (most frequently cited), social, and financial. The topic identified as most important remained stable over the follow-up. Patients were more likely to rate their involvement as active rather than passive for social decisions (odds ratio [OR]=5.7, p<.001) and financial decisions (OR=9.5, p<.001). They were more likely to report higher levels of satisfaction rather than lower levels for social decisions (OR=1.5, p=.01) and financial decisions (OR=1.7, p=.01). Social decisions were more likely to be partly implemented (OR=3.0, p<.001) or fully implemented (OR=1.7, p=.03) than not implemented. CONCLUSIONS Patients reported poorer involvement, satisfaction, and implementation in regard to treatment-related decisions, compared with social and financial decisions. Clinicians may need to employ different interactional styles for different types of decisions to maximize satisfaction and decision implementation.

Graded Exercise Therapy Guided Self-Help Trial for Patients with Chronic Fatigue Syndrome (GETSET): Protocol for a Randomized Controlled Trial and Interview Study

Background Chronic fatigue syndrome, also known as myalgic encephalomyelitis (CFS/ME), is characterized by chronic disabling fatigue and other symptoms, which are not explained by an alternative diagnosis. Previous trials have suggested that graded exercise therapy (GET) is an effective and safe treatment. GET itself is therapist-intensive with limited availability. Objective While guided self-help based on cognitive behavior therapy appears helpful to patients, Guided graded Exercise Self-help (GES) is yet to be tested. Methods This pragmatic randomized controlled trial is set within 2 specialist CFS/ME services in the South of England. Adults attending secondary care clinics with National Institute for Health and Clinical Excellence (NICE)-defined CFS/ME (N=218) will be randomly allocated to specialist medical care (SMC) or SMC plus GES while on a waiting list for therapist-delivered rehabilitation. GES will consist of a structured booklet describing a 6-step graded exercise program, supported by up to 4 face-to-face/telephone/Skype™ consultations with a GES-trained physiotherapist (no more than 90 minutes in total) over 8 weeks. The primary outcomes at 12-weeks after randomization will be physical function (SF-36 physical functioning subscale) and fatigue (Chalder Fatigue Questionnaire). Secondary outcomes will include healthcare costs, adverse outcomes, and self-rated global impression change scores. We will follow up all participants until 1 year after randomization. We will also undertake qualitative interviews of a sample of participants who received GES, looking at perceptions and experiences of those who improved and worsened. Results The project was funded in 2011 and enrolment was completed in December 2014, with follow-up completed in March 2016. Data analysis is currently underway and the first results are expected to be submitted soon. Conclusions This study will indicate whether adding GES to SMC will benefit patients who often spend many months waiting for rehabilitative therapy with little or no improvement being made during that time. The study will indicate whether this type of guided self-management is cost-effective and safe. If this trial shows GES to be acceptable, safe, and comparatively effective, the GES booklet could be made available on the Internet as a practitioner and therapist resource for clinics to recommend, with the caveat that patients also be supported with guidance from a trained physiotherapist. The pragmatic approach in this trial means that GES findings will be generalizable to usual National Health Service (NHS) practice. Trial Registration International Standard Randomized Controlled Trial Number (ISRTCTN): 22975026; http://www.isrctn.com/ISRCTN22975026 (Archived by WebCite at http://www.webcitation.org/6gBK00CUX)

Accounting for test reliability in student progression: the reliable change index

Developed by Jacobson and Truax, the reliable change index (RCI) provides a measure of whether the change in an individuals score over time is within or beyond that which might be accounted for by measurement variability. In combination with measures of whether an individuals final score is closer to those of one population or another, this provides useful individual‐level information that can be used to supplement traditional analyses.