Intervention development and treatment success in UK health technology assessment funded trials of physical rehabilitation: a mixed methods analysis.

OBJECTIVES: Physical rehabilitation is a complex process, and trials of rehabilitation interventions are increasing in number but often report null results. This study aimed to establish treatment success rates in physical rehabilitation trials funded by the National Institute of Health Research Health Technology Assessment (NIHR HTA) programme and examine any relationship between treatment success and the quality of intervention development work undertaken. DESIGN: This is a mixed methods study. SETTING: This study was conducted in the UK. METHODS: The NIHR HTA portfolio was searched for all completed definitive randomised controlled trials of physical rehabilitation interventions from inception to July 2016. Treatment success was categorised according to criteria developed by Djulbegovic and colleagues. Detailed textual data regarding any intervention development work were extracted from trial reports and supporting publications and informed the development of quality ratings. Mixed methods integrative analysis was undertaken to explore the relationship between quantitative and qualitative data using joint displays. RESULTS: Fifteen trials were included in the review. Five reported a definitive finding, four of which were in favour of the 'new' intervention. Eight trials reported a true negative (no difference) outcome. Integrative analysis indicated those with lower quality intervention development work were less likely to report treatment success. CONCLUSIONS: Despite much effort and funding, most physical rehabilitation trials report equivocal findings. Greater focus on high quality intervention development may reduce the likelihood of a null result in the definitive trial, alongside high quality trial methods and conduct.

Obesity: An Emerging Threat.

The World Health Organization (WHO) has identified obesity as a global health threat that has nearly tripled since 1975 (WHO, 2018). In 2016, of the 7.4 billion people in the world, more than 1.9 billion adults 18 years of age and older, were overweight. African-Americans were 1.4 times as likely to be obese as non-Hispanic Whites. Overweight and obesity are defined as abnormal or excessive fat accumulation that may impair health (WHO, 2018). The risk factors associated with obesity are cardiovascular, musculoskeletal, and cancer disorders (WHO, 2018). Policies that are currently in place addressing obesity are centered on nutrition, physical exercise, and parental involvement. The evidence shows that balanced diets and exercise could lead to healthy outcomes.

Clinical effectiveness and cost-effectiveness of collaborative care for depression in UK primary care (CADET): a cluster randomised controlled trial.

BACKGROUND: Collaborative care is effective for depression management in the USA. There is little UK evidence on its clinical effectiveness and cost-effectiveness. OBJECTIVE: To determine the clinical effectiveness and cost-effectiveness of collaborative care compared with usual care in the management of patients with moderate to severe depression. DESIGN: Cluster randomised controlled trial. SETTING: UK primary care practices (n = 51) in three UK primary care districts. PARTICIPANTS: A total of 581 adults aged ≥ 18 years in general practice with a current International Classification of Diseases, Tenth Edition depressive episode, excluding acutely suicidal people, those with psychosis, bipolar disorder or low mood associated with bereavement, those whose primary presentation was substance abuse and those receiving psychological treatment. INTERVENTIONS: Collaborative care: 14 weeks of 6-12 telephone contacts by care managers; mental health specialist supervision, including depression education, medication management, behavioural activation, relapse prevention and primary care liaison. Usual care was general practitioner standard practice. MAIN OUTCOME MEASURES: Blinded researchers collected depression [Patient Health Questionnaire-9 (PHQ-9)], anxiety (General Anxiety Disorder-7) and quality of life (European Quality of Life-5 Dimensions three-level version), Short Form questionnaire-36 items) outcomes at 4, 12 and 36 months, satisfaction (Client Satisfaction Questionnaire-8) outcomes at 4 months and treatment and service use costs at 12 months. RESULTS: In total, 276 and 305 participants were randomised to collaborative care and usual care respectively. Collaborative care participants had a mean depression score that was 1.33 PHQ-9 points lower [n = 230; 95% confidence interval (CI) 0.35 to 2.31; p = 0.009] than that of participants in usual care at 4 months and 1.36 PHQ-9 points lower (n = 275; 95% CI 0.07 to 2.64; p = 0.04) at 12 months after adjustment for baseline depression (effect size 0.28, 95% CI 0.01 to 0.52; odds ratio for recovery 1.88, 95% CI 1.28 to 2.75; number needed to treat 6.5). Quality of mental health but not physical health was significantly better for collaborative care at 4 months but not at 12 months. There was no difference for anxiety. Participants receiving collaborative care were significantly more satisfied with treatment. Differences between groups had disappeared at 36 months. Collaborative care had a mean cost of £272.50 per participant with similar health and social care service use between collaborative care and usual care. Collaborative care offered a mean incremental gain of 0.02 (95% CI -0.02 to 0.06) quality-adjusted life-years (QALYs) over 12 months at a mean incremental cost of £270.72 (95% CI -£202.98 to £886.04) and had an estimated mean cost per QALY of £14,248, which is below current UK willingness-to-pay thresholds. Sensitivity analyses including informal care costs indicated that collaborative care is expected to be less costly and more effective. The amount of participant behavioural activation was the only effect mediator. CONCLUSIONS: Collaborative care improves depression up to 12 months after initiation of the intervention, is preferred by patients over usual care, offers health gains at a relatively low cost, is cost-effective compared with usual care and is mediated by patient activation. Supervision was by expert clinicians and of short duration and more intensive therapy may have improved outcomes. In addition, one participant requiring inpatient treatment incurred very significant costs and substantially inflated our cost per QALY estimate. Future work should test enhanced intervention content not collaborative care per se. TRIAL REGISTRATION: Current Controlled Trials ISRCTN32829227. FUNDING: This project was funded by the Medical Research Council (MRC) (G0701013) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC-NIHR partnership.

Developing stepped care treatment for depression (STEPS): study protocol for a pilot randomised controlled trial.

BACKGROUND: Stepped care is recommended and implemented as a means to organise depression treatment. Compared with alternative systems, it is assumed to achieve equivalent clinical effects and greater efficiency. However, no trials have examined these assumptions. A fully powered trial of stepped care compared with intensive psychological therapy is required but a number of methodological and procedural uncertainties associated with the conduct of a large trial need to be addressed first. METHODS/DESIGN: STEPS (Developing stepped care treatment for depression) is a mixed methods study to address uncertainties associated with a large-scale evaluation of stepped care compared with high-intensity psychological therapy alone for the treatment of depression. We will conduct a pilot randomised controlled trial with an embedded process study. Quantitative trial data on recruitment, retention and the pathway of patients through treatment will be used to assess feasibility. Outcome data on the effects of stepped care compared with high-intensity therapy alone will inform a sample size calculation for a definitive trial. Qualitative interviews will be undertaken to explore what people think of our trial methods and procedures and the stepped care intervention. A minimum of 60 patients with Major Depressive Disorder will be recruited from an Improving Access to Psychological Therapies service and randomly allocated to receive stepped care or intensive psychological therapy alone. All treatments will be delivered at clinic facilities within the University of Exeter. Quantitative patient-related data on depressive symptoms, worry and anxiety and quality of life will be collected at baseline and 6 months. The pilot trial and interviews will be undertaken concurrently. Quantitative and qualitative data will be analysed separately and then integrated. DISCUSSION: The outcomes of this study will inform the design of a fully powered randomised controlled trial to evaluate the effectiveness and efficiency of stepped care. Qualitative data on stepped care will be of immediate interest to patients, clinicians, service managers, policy makers and guideline developers. A more informed understanding of the feasibility of a large trial will be obtained than would be possible from a purely quantitative (or qualitative) design. TRIAL REGISTRATION: Current Controlled Trials ISRCTN66346646 registered on 2 July 2014.

Cost-effectiveness of collaborative care for depression in UK primary care: economic evaluation of a randomised controlled trial (CADET).

BACKGROUND: Collaborative care is an effective treatment for the management of depression but evidence on its cost-effectiveness in the UK is lacking. AIMS: To assess the cost-effectiveness of collaborative care in a UK primary care setting. METHODS: An economic evaluation alongside a multi-centre cluster randomised controlled trial comparing collaborative care with usual primary care for adults with depression (n = 581). Costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICER) were calculated over a 12-month follow-up, from the perspective of the UK National Health Service and Personal Social Services (i.e. Third Party Payer). Sensitivity analyses are reported, and uncertainty is presented using the cost-effectiveness acceptability curve (CEAC) and the cost-effectiveness plane. RESULTS: The collaborative care intervention had a mean cost of £272.50 per participant. Health and social care service use, excluding collaborative care, indicated a similar profile of resource use between collaborative care and usual care participants. Collaborative care offered a mean incremental gain of 0.02 (95% CI: -0.02, 0.06) quality-adjusted life-years over 12 months, at a mean incremental cost of £270.72 (95% CI: -202.98, 886.04), and resulted in an estimated mean cost per QALY of £14,248. Where costs associated with informal care are considered in sensitivity analyses collaborative care is expected to be less costly and more effective, thereby dominating treatment as usual. CONCLUSION: Collaborative care offers health gains at a relatively low cost, and is cost-effective compared with usual care against a decision-maker willingness to pay threshold of £20,000 per QALY gained. Results here support the commissioning of collaborative care in a UK primary care setting.

Clinical effectiveness of collaborative care for depression in UK primary care (CADET): cluster randomised controlled trial.

OBJECTIVE: To compare the clinical effectiveness of collaborative care with usual care in the management of patients with moderate to severe depression. DESIGN: Cluster randomised controlled trial. SETTING: 51 primary care practices in three primary care districts in the United Kingdom. PARTICIPANTS: 581 adults aged 18 years and older who met ICD-10 (international classification of diseases, 10th revision) criteria for a depressive episode on the revised Clinical Interview Schedule. We excluded acutely suicidal patients and those with psychosis, or with type I or type II bipolar disorder; patients whose low mood was associated with bereavement or whose primary presenting problem was alcohol or drug abuse; and patients receiving psychological treatment for their depression by specialist mental health services. We identified potentially eligible participants by searching computerised case records in general practices for patients with depression. INTERVENTIONS: Collaborative care, including depression education, drug management, behavioural activation, relapse prevention, and primary care liaison, was delivered by care managers. Collaborative care involved six to 12 contacts with participants over 14 weeks, supervised by mental health specialists. Usual care was family doctors' standard clinical practice. MAIN OUTCOME MEASURES: Depression symptoms (patient health questionnaire 9; PHQ-9), anxiety (generalised anxiety disorder 7; GAD-7), and quality of life (short form 36 questionnaire; SF-36) at four and 12 months; satisfaction with service quality (client satisfaction questionnaire; CSQ-8) at four months. RESULTS: 276 participants were allocated to collaborative care and 305 allocated to usual care. At four months, mean depression score was 11.1 (standard deviation 7.3) for the collaborative care group and 12.7 (6.8) for the usual care group. After adjustment for baseline depression, mean depression score was 1.33 PHQ-9 points lower (95% confidence interval 0.35 to 2.31, P=0.009) in participants receiving collaborative care than in those receiving usual care at four months, and 1.36 points lower (0.07 to 2.64, P=0.04) at 12 months. Quality of mental health but not physical health was significantly better for collaborative care than for usual care at four months, but not 12 months. Anxiety did not differ between groups. Participants receiving collaborative care were significantly more satisfied with treatment than those receiving usual care. The number needed to treat for one patient to drop below the accepted diagnostic threshold for depression on the PHQ-9 was 8.4 immediately after treatment, and 6.5 at 12 months. CONCLUSIONS: Collaborative care has persistent positive effects up to 12 months after initiation of the intervention and is preferred by patients over usual care. TRIAL REGISTRATION NUMBER: ISRCTN32829227.

Multisource feedback in evaluating the performance of doctors: the example of the UK General Medical Council patient and colleague questionnaires.

PURPOSE: Internationally, there is increasing interest in monitoring and evaluating doctors' professional practice. Multisource feedback (MSF) offers one way of collecting information about doctors' performance. The authors investigated the psychometric properties of two questionnaires developed for this purpose and explored the biases that may exist within data collected via such instruments. METHOD: A cross-sectional study was conducted in 11 UK health care organizations during 2008-2011. Patients (n = 30,333) and colleagues (n = 17,012) rated the professional performance of 1,065 practicing doctors, using the General Medical Council Patient Questionnaire (PQ) and Colleague Questionnaire (CQ). The psychometric properties of the questionnaires were assessed, and regression modeling was used to explore factors that influenced patient and colleague responses on the core questionnaire items. RESULTS: Although the questionnaires demonstrated satisfactory internal consistency, test-retest reliability, and convergent validity, patient and colleague ratings were highly skewed toward favorable impressions of doctor performance. At least 34 PQs and 15 CQs were required to achieve acceptable reliability (G > 0.70). Item ratings were influenced by characteristics of the patient and colleague respondents and the context in which their feedback was provided. CONCLUSIONS: The PQ and CQ are acceptable for the provision of formative feedback on a doctor's professional practice within an appraisal process. However, biases identified in the questionnaire data suggest that caution is required when interpreting and acting on this type of information. MSF derived from these questionnaires should not be used in isolation to inform decisions about a doctor's fitness to practice medicine.

Multisource feedback questionnaires in appraisal and for revalidation: a qualitative study in UK general practice.

BACKGROUND: UK revalidation plans for doctors include obtaining multisource feedback from patient and colleague questionnaires as part of the supporting information for appraisal and revalidation. AIM: To investigate GPs' and appraisers' views of using multisource feedback data in appraisal, and of the emerging links between multisource feedback, appraisal, and revalidation. DESIGN AND SETTING: A qualitative study in UK general practice. METHOD: In total, 12 GPs who had recently completed the General Medical Council multisource feedback questionnaires and 12 appraisers undertook a semi-structured, telephone interview. A thematic analysis was performed. RESULTS: Participants supported multisource feedback for formative development, although most expressed concerns about some elements of its methodology (for example, 'self' selection of colleagues, or whether patients and colleagues can provide objective feedback). Some participants reported difficulties in understanding benchmark data and some were upset by their scores. Most accepted the links between appraisal and revalidation, and that multisource feedback could make a positive contribution. However, tensions between the formative processes of appraisal and the summative function of revalidation were identified. CONCLUSION: Participants valued multisource feedback as part of formative assessment and saw a role for it in appraisal. However, concerns about some elements of multisource feedback methodology may undermine its credibility as a tool for identifying poor performance. Proposals linking multisource feedback, appraisal, and revalidation may limit the use of multisource feedback and appraisal for learning and development by some doctors. Careful consideration is required with respect to promoting the accuracy and credibility of such feedback processes so that their use for learning and development, and for revalidation, is maximised.

The 'Reading the Mind in the Voice' test-revised: a study of complex emotion recognition in adults with and without autism spectrum conditions.

This study reports a revised version of the 'Reading the Mind in the Voice' (RMV) task. The original task (Rutherford et al., (2002), Journal of Autism and Developmental Disorders, 32, 189-194) suffered from ceiling effects and limited sensitivity. To improve that, the task was shortened and two more foils were added to each of the remaining items. About 50 adults with Asperger Syndrome (AS) or High Functioning Autism (HFA) and 22 matched controls took the revised task. Results show the revised task has good reliability and validity, is harder, and more sensitive in distinguishing the AS/HFA group from controls. Verbal IQ was positively correlated with performance, and females performed worse than males in the AS/HFA group. Results are discussed with regard to multi modal empathizing deficits in autism spectrum conditions (ASC).

The "reading the mind in films" task: complex emotion recognition in adults with and without autism spectrum conditions.

BACKGROUND: Individuals with autism spectrum conditions (ASC) have difficulties recognizing mental states in others. Most research has focused on recognition of basic emotions from faces and voices separately. This study reports the results of a new task, assessing recognition of complex emotions and mental states from social scenes taken from feature films. The film format arguably is more challenging and ecologically closer to real social situations. SAMPLE AND METHOD: A group of adults with ASC (n=22) were compared to a group of matched controls from the general population (n=22). Participants were tested individually. RESULTS: Overall, individuals with ASC performed significantly lower than controls. There was a positive correlation between verbal IQ and task scores. Using task scores, more than 90% of the participants were correctly allocated to their group. Item analysis showed that the errors individuals with ASC make when judging socioemotional information are subtle. CONCLUSIONS: This new test of complex emotion and mental state recognition reveals that adults with ASC have residual difficulties in this aspect of empathy. The use of language-based compensatory strategies for emotion recognition is discussed.

The role of mentoring in developing African American nurse leaders.

The primary purpose of this study was to explore the role of mentoring in the development of African American nurses who have achieved leadership positions in baccalaureate and graduate nursing programs. This study also explored similar and dissimilar mentoring experiences in same-race versus cross-race mentoring relationships. The theoretical framework for this study was Levinson's adult developmental theory. A sequential mixed design was utilized. Forty-seven African American nurse leaders participated in Phase 1, and 10 of the 47 were interviewed in Phase 2. The findings showed that mentoring plays a role in the personal and professional development of African American nurse leaders in baccalaureate and graduate nursing programs. Moreover, the relevance of race varies in both same-race and cross-race mentoring relationships.